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  • Li Jinfeng, Yan Xiujuan, Zhang Jinbiao, Zhang Yuan
    . 2015, 17(3): 230.
    A 63-year-old female with non-Hodgkin's lymphoma was treated with a chemotherapeutic regimen composed of rituximab, cyclophosphamide, doxorubicin, vincristine, prednisolone (R-CHOP). She was given  rituximab 600 mg plus 750 ml of 0.9% sodium chloride injection intravenous drip on the first day, at the same time treatments for hydration, alkalization, protecting visceral function, prevention of adverse reactions were given. On day 2, the patient developed an involuntary shaking limbs, a lower limbs weakness, a slightly slow reaction and an unsteady gait. MRI of the brain did not show any significant finding. On day 3, she had a fever, cognitive impairment and confusion. On day 4, the patient could not have independent feeding and defecation. Methyl prednisolone, drugs for improving microcirculation and rehydration therapy were applied. Two days later, the patient's consciousness restored. He can eat independently, defecate by himself, and his limbs and neuropsychological symptoms were relieved. Five days later, the symptoms were apparently   improved.
  • Ma Xue, Jiang Gang
    . 2015, 17(3): 227.
    Two female patients, aged 61 and 48 years old, received a combined chemotherapy of irinotecan 200 mg and lonaplatin 50 mg for cervical cancer. Patient 1 developed diarrhea, grade IV arrest of bone marrow and septicemia, accompanied by septic shock on the ninth day after the second cycle of chemotherapy. Patient 2 developed diarrhea, grade IV arrest of bone marrow, accompanied by fever on the sixth day after the first cycle of chemotherapy, and then developed secondary septicemia. Antidiarrhea, anti-infection, and immune support treatment were given. Five days later, diarrhea was controlled. Ten days later for patient 1 and six days later for patients 2, white blood cell, hemoglobin and platelet count were within normal range. After twenty days for patient 1 and six days later for patients 2, septicemia was controlled.
  • . 2015, 17(2): 101-103.
  • Si Xiaobei, Lan Yu
    . 2015, 17(3): 218.
    The proton pump inhibitors (PPI) are widely used as the treatment of choice in acid-related diseases in clinic. Long term use of PPI may further induce abnormal absorption of nutrition (vitamin B12, calcium, iron, magnesium and other minerals), abnormal proliferation of gastrointestinal mucosa, infection, and abnormal bone metabolism (osteoporosis and bone fracture), and so on. Most studies on safety of long term use of PPI are retrospective cohorts or case-control studies. More prospective randomized controlled trials should be performed and good clinical evidences should be obtained for reasonable and safe use of PPI.
  • Wang Shujun;Qian Jiaming
    . 2015, 17(1): 1-2.
  • Yan Yan;Wang Yuqin;Shen Qian;Jiang Dechun;Li Xiaoling;Liu Chen;Li Xingwei
    . 2015, 17(1): 19-8.
    ObjectiveTo develop a list of potentially inappropriate medication (PIM) for the Chinese aged people and provide reference for prevention and reduce the medication risk of the aged people.MethodsBased on the PIM lists of the United States, Canada, Japan, France, Norway, Germany, South Korea and Austria, and combined with the data of serious adverse drug reactions (ADR) in the aged people collected from China National Center for ADR Monitoring, ADR monitoring center in the People′s Liberation Army, Beijing Center for ADR Monitoring and ADR data from Beijing 22 hospitals, we created a preliminary PIM list for the Chinese aged people. Using Delphi technique experts consultation was made for the initial list. Round 1 consultantation invited 32 experts, according to the expert advice to adjust the initial list, and form a revised list. Round 2 consultantation invited 38 experts, according to the expert advice to adjust revised list, and the final version of the PIM list formed. ResultsA total of 13-class 72 medications or medication classes were selected as the Chinese aged people PIM list, each medicine had 1-6 risk points. The list was divided according to the result of expert evaluation into 35 kinds of high risk medications and 37 kinds of low risk medications. In addition, according to the frequency of drug use, the medications were divided into A and B two categories, including 24 medications or medication classes as the preferred alert medications (A), 48 medications or medication classes as routinely alert medications (B).ConclusionPIM list for the Chinese aged people have been developed, which can be taken as reference to intervention and evaluation of China′s elderly medication.
  • an Guobao;Lei Zhaobao
    . 2015, 17(1): 15-4.

    ObjectiveTo analyze the clinical characteristics and risk factors of lansoprazole-induced microscopic colitis (MC).MethodsPubMed, Da-Yi medical search, CHKD and Wanfang databases were searched and articles related to MC induced by lansoprazole were collected. The patients′primary diseases, coexisting diseases, the dosage, the way of administration, combination drugs, latent period, clinical manifestations, colonoscopic findings, the treatment measures, and the outcomes were recorded and the clinical characteristics, the risk factors of MC induced by lansoprazole were analyzed.ResultsA total of 30 articles and 62 patients with MC induced by lansoprazole were retrieved. All articles were case reports and no randomized controlled trials were found. Of all the 62 patients, 22 were male (35.5%) and 40 were female (64.5%) with age from 36 to 92 years and the average age was (69±12) years; 57 patients (91.9%) were >50 years; 43 patients were with collagenous colitis (CC) (69.4%) , 18 patients (29%) were with lymphocytic colitis (LC), and one patient with LC changed into CC (1.6%). All patients were treated with oral lansoprazole. The latent period of MC induced by lansoprazole were 5d-6 years and within 1-6 months in 31 patients (60.8%) . The most common clinical manifestations were non-bloody watery diarrhea (3-10 times daily in 59 patients, >10 times daily in 3 patients). Intestinal mucosal screening was performed for all the patients and mild abnormalities or edema were observed in 37 patients, mucosal defect and mucosal laceration in 11 patients, epithelial collagen layer thickening, inflammatory cells infiltration in lamina propria, increased lymphocytes in intraepithelial spaces in 18 patients. High-risk drugs for drug-induced MC were combined use in 20 patients and the combination drugs in 13 patients were non steroidal anti-inflammatory drugs. Fifty-eight patients with mild or moderate drug-induced MC returned to normal after withdrawl of lansoprazole and treatment with omeprazole or rabeprazole sodium and 4 patients with severe drug-induced MC recovered after withdrawl of lansoprazole and treatment with glucocorticoids.ConclusionsThe clinical characteristics in patients with MC induced by lansoprazole are watery diarrhea, mild abnormality or edema of colon mucosa, and thickening in the epithelium of colonic mucosa in histopathology. Age, gender, and combined use of drugs may be related to occurrence of MC induced by lansoprazole.

  • Wu Rui; Zhao Yi' Li Xiaoxia
    . 2015, 17(3): 170.
    ObjectiveTo observe the adverse reactions of zoledronic acid in the treatment of osteoporosis combined with rheumatic diseases and analyze the potential risk factors.MethodsMedical record data of patients with rheumatic diseases and osteoporosis who were treated with zoledronic acid during hospitalization in Xuanwu Hospital of Capital Medical University from January 2011 to December 2014 were collected and a retrospective analysis was conducted. The patients were grouped according to the occurrence of adverse reactions and their demographic characteristics, types of rheumatic diseases and medication regimen of zoledronic acid were compared. The screened risk factors for adverse reactions were analyzed by multivariate logistic regression. The results were expressed by odds ratio (OR) and 95% confidence intervals (CI).ResultsA total of 120 patients were enrolled into the study. There were 41 males and 79 females. Their ages ranged from 23 to 85 years. Of 120 patients, 64 cases (53.3%) received first infusion of zoledronic acid, 66 cases (55.0%) received the treatment with corticosteroids during hospitalization, 58 cases (48.3%) were given antipyretic analgesics before infusion of zoledronic acid and 64 cases (53.3%) received sufficient hydration before and after the infusion; 49 (40.8%) of the 120 patients were reported to have adverse reactions. All adverse reactions were of acute phase responses, including fever in 32 (65.3%), flu-like symptoms in 21 (42.9%), headache in 17 (34.7%), fatigue in 12 (24.5%), myalgia in 10 (20.4%), arthralgia in 8 (16.3%), chills in 6 (12.2%), nausea in 5 (10.2%), vomiting in 4 (8.2%), and dry cough in 1 (2.0%). No severe adverse events occurred. The incidence of adverse reactions in initial infusion patients was significantly higher than that in non-initial infusion patients[51.6% (33/64) vs. 28.6% (16/56), P=0.011]. The incidence of adverse reactions in patients with  corticosteroid therapy was significantly lower than that in patients with no corticosteroid therapy[24.2% (16/66) vs. 61.1% (33/54), P<0.001]. The patients who were given sufficient hydration before and after the infusion also had significantly lower incidence of adverse reactions than those without sufficient hydration treatments[31.2% (20/64) vs. 51.8% (29/56), P=0.023]. Multivariate logistic regression analysis suggested that initial infusion was a risk factor for adverse reactions (OR=2.631, 95%CI: 1.132-6.116, P=0.025). However, oral corticosteroid and sufficient hydration treatments before and after the infusion were protective factors (OR=0.232, 95%CI: 0.102-0.526, P<0.001; OR=0.379, 95%CI: 0.164-0.874, P=0.023).ConclusionsAcute phase responses related to zoledronic acid are common in the treatment of patients with rheumatic diseases and osteoporosis. Iniaial infusion is closely associated with adverse reactions of zoledronic acid, but oral corticosteroid and sufficient hydration treatments before and after the infusion might decrease the incidence of adverse reactions.
  • Meng Yan
    . 2015, 17(3): 214.
    ObjectiveTo analyze the characteristics of highly cited papers published in Adverse Drug Reactions Journal (our journal) during 2009 to 2013, understand the hot spots of subject development and demands of readers, and improve impact and quality of our journal. MethodsThe citation frequency of papers published in our journal from 2009 to 2013 was searched in China Academic Journal Network Publishing Database (as of April 30, 2015). Price law was used to determine the highly cited papers. The main statistical parameters included total citation frequency of papers published in our journal, average citation frequency of papers, citation frequency of highly cited papers, and average citation frequency of highly cited papers. The distribution of subjects of highly cited papers, regional distribution of authors, distribution of article types, and funding  sources were analyzed descriptively.ResultsA total of 1 052 articles were searched and 736 articles were entered into the study, including 147 original articles, 85 reviews, and 504 case reports. Of the 736 articles, 517 were cited (70.2%) and the total citation frequency was 2 170 times and average citation frequency of papers was 4 times. According to the Price law, the papers which were cited ≥5 times were considered as highly cited papers in our journal during the study period. The citation frequency of 138 highly cited papers was 1 388 times which accounted for 64.0% of total frequency (2  170 times) during the study period and average citation frequency of highly cited papers was 10 times. The subjects of highly cited 138 papers are relatively centered and the top 5 subjects were antimicrobial agents (44 papers, 31.9%), Chinese Medicine (22, 15.9%), cardiovascular system drugs (19, 13.8%), antineoplastic drugs (11, 8.0%), and endocrine system drugs (5, 3.6%); there were 87 papers (63.0%) distributed in Beijing and 51 papers (37.0%) distributed in other 17 provinces or municipality directly under the central government; 33 of the highly cited 138 papers were original articles (23.9%), 29 were reviews (21.0%), and 76 were case reports (55.1%), their citation frequency was 390, 354, and 643, respectively which accounted for 28.1%, 25.5% and 46.3% of total citation frequency 1 388 times, respectively, and the average citation frequency of original articles, reviews, or case reports were 12,12, and 9, respectively. There was 1 paper supported by National funds at top 20 highly cited papers.ConclusionsAs highly cited papers published in our journal, distribution of subjects and regions were relatively centered; distribution of authors were dispersive; reviews and case reports made more contributions; and average citation frequency of original articles and reviews was higher. It is valuable to understand the above mentioned characteristics to make measures for improvement of impact and quality of our journal.
  • Liu Jun;Zhu Yanhong
    . 2015, 17(1): 60-2.
    A 76-year-old male patient with acute coronary syndrome received regularly aspirin (0.1 g once daily), clopidogrel (50 mg once daily), atorvastatin calcium (20 mg once daily), and isosorbide mononitrate (10 mg twice daily) by mouth after undergoing percutaneous coronary intervention. He suffered from left lumbago with gross hematuria after 2 months of treatments. Laboratory tests showed the following values:urine occult blood(+++),235 red blood cells per microlitre and 17 red blood cells per high power field. Urinary system ultrasonography and renal function detection showed no abnormalities. Aspirin and clopidogel were withdrawn and the symptomatic treatments were given. Two days later, the patient′s urine recovered to normal,his left lumbago was alleviated, and the red blood cell in his urine was negative. Gene polymorphism detection of cytochrome P-450(CYP)2C19 showed that the patient carried CYP2C19*17(CT) allele and CYP2C19 enzyme had ultra rapid metabolism. Aspirin was given orally and the hematuria did not appear again.
  • Adverse Drug Reactions Journal. 2020, 22(8): 496-496.
  • Center for Drug Reevaluation, National Medical Products Administration; Chinese Pharmacists Association et al
    Adverse Drug Reactions Journal. 2022, 24(6): 284-294. https://doi.org/10.3760/cma.j.cn114015-20220503-00384
    As stated by article 12 of the Drug Administration Law of the People′s Republic of China, the state shall construct pharmacovigilance regulations to monitor, identify, assess, and control adverse drug reactions and other harmful events related to medication. Pharmacovigilance runs throughout the whole life cycle of drug from research and development to clinical use, and the core idea is to prevent and control medication risks and ensure the safety of patients and the general public. As the main places for drug consumption and the key participants in pharmacovigilance activities, the construction of pharmacovigilance system in health facilities is an important part in the construction of national pharmacovigilance regulations. At present, we are at the initial stage of the implementation of national pharmacovigilance regulations. In order to promote the establishment of pharmacovigilance system in health facilities, domestic pharmacovigilance monitoring institutions, relevant academic groups, medical colleges and universities, periodical offices, and social welfare organizations jointly initiate the compilation of Expert consensus on construction of pharmacovigilance system in health facilities by inviting experts and scholars in relevant fields to discuss, distinguish, and analyze the important concepts on adverse drug reactions/events, medication safety, pharmacovigilance, etc., in combination with cutting-edge developments. The consensus puts forward systematic principles and methods on establishing pharmacovigilance system, expecting to provide reference to health facilities in pharmacovigilance system establishment.
  • Wang Yuan, Wang Yan, Ma Ming, Pei Fei
    Adverse Drug Reactions Journal. 2022, 24(12): 658-663. https://doi.org/10.3760/cma.j.cn114015-20220905-00811
    Chemotherapy-induced peripheral neuropathy (CIPN) usually manifests as persistent pain and sensory abnormalities, and in severe cases, loss of vibration and joint position sensation, autonomic and motor dysfunction may occur, severely affecting patients′ quality of life. Mitochondrial dysfunction may be one of the mechanisms by which chemotherapeutic drugs induce peripheral neuropathy. Different mitochondrial dysfunction caused by different chemotherapy agents are reviewed from 5 aspects in this paper, including abnormal neuronal mitochondrial morphology, activation of mitochondrial permeability transition pore and its associated calcium imbalance, dysfunction of mitochondrial bioenergetics, oxidative stress, and abnormal axonal mitochondrial transport. Avoiding or improving mitochondrial dysfunction is the main strategy to prevent or mitigate CIPN.
  • Wang Qingyu, Chen Zhuang
    Adverse Drug Reactions Journal. 2023, 25(8): 497-503. https://doi.org/10.3760/cma.j.cn114015-20221110-01046
    A perfect pharmacovigilance database is the core pillar of pharmacovigilance activities. At present, the United States, Japan, Europe, and the World Health Organization have all established comparatively mature pharmacovigilance databases, which have played an important role in adverse drug reaction (ADR) monitoring, ADR signal mining, and post marketing re-evaluation of drugs. This paper summarizes the data sources, data accessibility, available elements, data quality control, and data utilization status of the 4 major databases mentioned above, so as to provide references for clinical pharmacovigilance activities and improvement of the construction of pharmacovigilance database in China.
  • Cheng Gangying, Deng Aiping, Wang Yi, Liu Jue, Zhou Qing
    . 2017, 19(1): 74-75.
    A 45-year-old man with about 10 years of drug abuse history took 96 tablets of sodium valproate sustained-release (48 g) and about 20 capsules of ziprasidone hydrochloride (>400 mg) by himself one time. He appeared comatous and had no response to being called, then he was sent to the hospital by his family members. He presented no autonomous respiration, hypotonia of the four limbs and neck (2 level) on admission. He received symptomatic supportive treatments including tracheal intubation and ventilator assisted breathing, gastric lavage, coloclyster, fluid infusion,  diuresis, and central nervous system stimulant, immediately. Two hours later, the patient awoke. Laboratory tests revealed the following results: arterial oxygen partial pressure (PaO2) 292 mmHg (1 mmHg=0.133 kPa), lactic acid 5.70 mmol/L, D-dimer 7.8 mg/L, plasma fibrinogen degradation product (FDP) 45 mg/L. Twenty-four hours later, laboratory tests revealed the following results:  PaO2  98 mmHg, lactic acid 1.7 mmol/L, D-dimer 2.2 mg/L, FDP 19 mg/L. The trachea cannula was removed. Forty-eight hours later, his consciousness returned to normal. He could finish the common action. But he still had the symptom of  drowsiness. Seven days later, the patient could answer questions accurately. His muscular tension returned to normal. He had light drowsiness occasionally.
  • Zhou Li, Luo Yongwei, Wang Yong, Jiang Juan, Jia Yuling, Gui Bo, Chong Liming, Sun Zuyue
    . 2015, 17(3): 204.
    ObjectiveTo explore the relationships between active systemic allergic reaction induced by breviscapine injection and the drug dose and the sensitization time.MethodsActive systemic allergic reaction in guinea pigs was used as experimental method. Forty-eight guinea pigs were divided into 6 groups according to random number table: breviscapine injection 1, 5, 25 and 50 mg/kg group (the breviscapine injection group 1, 2, 3, 4), 0.9% sodium chloride injection group (the negative control group) and bovine serum albumin (BSA) control group (the positive control group). Each group comprised 8 guinea pigs. Sensitization: the guinea pigs in group 1 to 4 were given the breviscapine injection  at doses of 1, 5, 25 and 50 mg/kg (0.5 ml) by intraperitoneal injection every other day for three times, respectively. The the guinea pigs in the negative control group and the positive control group were given 0.9% sodium chloride injection (0.5 ml) and bovine serum albumin (BSA) 20 mg/kg by intraperitoneal injection every other day for 3 times, respectively. Excitation: the sensitized guinea pigs in each group were divided into 2 subgroups, each subgroup comprised 4 guinea pigs. On the 14 and 21 days after the last sensitization, the guinea pigs in breviscapine 1 to 4 subgroups received 2 times of breviscapine injection intravenously (1.0 ml), respectively. The guinea pigs in the negative and the positive control subgroups  received 2 times of control articles intravenously, respectively. The symptoms of anaphylactic reaction (pilo-erection, shiver, scratching nose, sneeze, cough, vomiturition, cyanosis, dyspnea, urinary and fecal incontinence, instability of gait or tumble, convulsion or hyperspasmia, shock and death) were observed every day during the sensitization phase. The guinea pigs′ reactions which appeared in 30 min after intravenous injections were observed and the occurrence time of allergic symptoms/signs were recorded attentively. The anaphylactic reaction was determined according to the Chinese Pharmacopoeia′s allergic reaction test. ResultsThe guinea pigs in 6 groups did not show any allergic symptoms in the sensitization phase. Within 30 min in fourteenth days′ excitation,  2, 4, 4, 4 guinea pigs developed allergic reactions in the breviscapine 1 to 4 groups, respectively. But none of them were identified as allergic reaction. The 4 guinea pigs in the positive control group were judged to have positive allergic reaction. Within 30 min of 21 days′ excitation, 4、3、4、4 guinea pigs developed allergic reactions in the breviscapine 1 to 4 groups, respectively. Only one guinea pig in the breviscapine 4 group was identified as allergic reaction. The 4 guinea pigs in the positive control group were all judged positive allergic reaction. The guinea pigs in the negative control group did not develop any allergic reactions during the 2 times of excitation. The occurrence time of allergic reactions in the breviscapine groups (within 20 min after excitation) on 21 days′ excitation was shorter than those (within 25 min after excitation) occurred on 14 days′ excitation, but the difference was not statistically significant.ConclusionsThe active systemic allergic reactions induced by breviscapine injection are associated with drug dose and sensitization time. The larger dose and longer sensitization time can increase the risk of allergic reaction and shorten the latency of allergic reaction.
  • Pan Chen, Cao Mingnan, Yin Hang, Liu Ranjia, Han Qiang, Cui Xiangli
    Adverse Drug Reactions Journal. 2022, 24(11): 591-598. https://doi.org/10.3760/cma.j.cn114015-20220324-00238
    Objective To explore the international research hotpots and development trend of therapeutic drug monitoring (TDM). Methods Web of Science database was searched as of February 16, 2022, with search term of "therapeutic drug monitoring" or "drug monitoring". The research articles on TDM were collected and analyzed for the annual publication amount, countries, authors, and institutions. Citation burst was detected using CiteSpace software, and keywords-cluster was carried out by VOSviewer to visually show the research hotpots. Results A total of 2-318 articles were included, and the first one was published in 1975. The United States published the largest amount of related articles and had the closest cooperation with other countries. University of Queensland in Australia was the institution with the most publications, and Roberts JA was the author with the most publications. A total of 10 citation bursts were detected, and 6 keywords-clusters related to TDM were found by cluster analysis method. Recent international research hotspots included TDM of biologics in patients with inflammatory bowel disease, TDM of anti-infective drugs in critically ill patients, and TDM of anti-tumor drugs. Conclusions Referring to the international research hotspots, TDM should be carried out for more drugs, such as infliximab, adalimumab, and imatinib, etc., to provide personalized and precise medication care for patients and improve the safety of drug therapy.
  • Adverse Drug Reactions Journal. 2021, 23(4): 224-224.
  • Lin Zhiqiang, Zhang Qingquan, Chen Tingting
    Adverse Drug Reactions Journal. 2020, 22(7): 409-415. https://doi.org/10.3760/cma.j.cn114015-20190617-00501
    From March 2013 to December 2018, Japan, the United Kingdom, Canada, Australia, and China successively issued guidelines on therapeutic drug monitoring of voriconazole. It is recommended in guidelines at home and abroad that voriconazole should be given a loading dose, and the blood drug concentration of patients should be monitored on the third day; when adjusting the dose, adverse events occurrence or poor efficacy, increasing or stopping the drugs that may interact, and sequential administration, the blood drug concentration should be monitored again. The clinical characteristics of voricona- zole-related adverse events have been clearly defined. After adverse reactions occur during the treatment period, the drug can be stopped or reduced according to its severity. Voriconazole is not only the substrate of cytochrome P450 (CYP) 2C9, CYP2C19 and CYP3A4, but also an inhibitor of them. We should pay attention to the interaction between voriconazole and other drugs.  In the future, further research is needed to accumulate more evidence-based medical evidences for the use of the drug in different medication purposes, different diseases or different fungal infections, Child-Pugh grade C severe liver disease, and children <2 years old, so as to provide reference for clinical individualized treatment.
  • Ding Likun, Fan Tingting, Liu Meiyou, Guan Yue, Wang Jingwen, Wen Aidong
    Adverse Drug Reactions Journal. 2022, 24(9): 484-489. https://doi.org/10.3760/cma.j.cn114015-20210823-00920
    Monoclonal antibody (mAb) drugs belong to protein drugs, which are characterized by high relative molecular weight, strong polarity, and limited transmembrane. Their pharmacokinetics have certain particularity and complexity, and problems such as large individual differences in therapeutic effects, diverse biological effects, and loss of therapeutic response exist in clinical application. The blood concentration of mAb drugs is affected by many factors including the number of receptors at the target site, the level of anti-drug antibody, and the interaction between drugs. Early monitoring is helpful to timely adjust the dose of mAb drugs, improve the efficacy, and avoid or reduce the occurrence of adverse reactions. Clinical monitoring should be actively carried out to improve the level of rational use of mAb drugs and the ability of early warning of adverse reactions, so as to reduce the drug-induced injury in patients.
  • Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, et al
    Adverse Drug Reactions Journal. 2022, 24(8): 396-403. https://doi.org/10.3760/cma.j.cn114015-20220101-01321
    There are risks in the use and management of perioperative analgesics, which may be caused by analgesic methods, individual patient factors, or medication errors. In order to reduce the risk in perioperative analgesics use and improve the level of safe drug use, Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, Chinese Pharmacological Society Professional Committee of Drug-induced Diseases, Adverse Drug Reactions Journal Agency, Beijing Municipal Health Commission Clinical Safety Medication Working Group organize the domestic pharmacy experts and anesthesiology experts to formulate the guideline. The risks prevention and management measures of perioperative analgesics were described from 3 aspects including management, drugs, and special populations. The management- related risks include the risks during the formulation of analgesia plan, the risks in information/goods/drugs transmission, the risks in the use of intraoperative analgesics and analgesia pumps, which can be prevented by formulating rules and regulations, strengthening training, and improving information technology. Drug-related risks are inherent properties of drugs. Analgesics are classified into narcotic analgesics, antipyretic analgesics, and analgesic auxiliary drugs. Corresponding prevention strategies can be formulated according to the risk points of specific drugs. Special populations including the elderly, pregnant and lacta- ting women, and children, etc. have their own physiological and pharmacokinetic characteristics and countermeasures can be formulated according to specific conditions. Through comprehensive monitoring of perioperative analgesics use, the risk can be predicted, the circumvention plan can be formulated, and the pharmaceutical care can be implemented, so as to ensure the medication safety of patients. This guideline is applicable to all medical personnel who use and monitor perioperative analgesics.
  • Xiao Changqian;Han Qi
    . 2015, 17(1): 55-2.
    A 79-year-old man received an intravenous (IV) infusion of cefoperazone sodium and sulbactam sodium 1.5 g every 12 hours with concomitant use of levofloxacin 0.5 g once daily,doxofylline injection 0.2 g via pump twice daily, and an IV push of 45 mg ambroxol injection twice daily for acute exacerbation of chronic obstructive pulmonary disease. Levofloxacin was discontinued after 7 days of treatments ambroxol and doxofylline were discontinued after 13 days of treatments. Just after completion of the infusion of cefoperazone sodium and sulbactam sodium on day 16 of treatment, the patient suddenly experienced unconsciousness, convulsion of extremities, gnathospasmus, and eyes gazing rightwards, which lasted about one minute. An IV injection of methylprednisolone sodium succinate 40 mg was given immediately and 1 minute later, his consciousness restored and symptoms relieved. And then an IV injection of sodium valproate 400 mg and sodium valproate 30 mg/h via a pump were given. On day 17, 2 hours after completion of the infusion of cefoperazone sodium and sulbactam sodium, the symptoms mentioned above appeared again. An IV push of diazepam 5 mg and sodium valproate 80 mg/h were given and 2 minutes later, the symptoms alleviated gradually. Subsequently, cefoperazone sodium and sulbactam sodium was discontinued, an IV push of sodium valproate 400 mg once daily and an oral sodium valproate 0.5 g twice daily were given. After that, he didn′t experience epilepsy seizure again.
  • Wang Shihui, Cui Xiangli
    . 2017, 19(2): 149-150.
    An 81-year-old female patient with pulmonary infection was given cefoxitin 2 g by intravenous drip. After 1.5 hours of treatment, the patient self-medicated with compound glycyrrhiza oral solution 10 ml for cough. About 10 minutes later, she experienced chest tightness, dyspnea, facial flushing, hyperhidrosis, weakness of limbs and rash. Disulfiram reaction was considered. Intravenous dexamethasone 10 mg and continuous low flow oxygen were given. About 30 minutes later, the patient′s condition improved. After 2 hours, the symptoms disappeared.
  • Sun Bo, Liu Xun, Zhang Erfeng, Ma Huanqing
    Adverse Drug Reactions Journal. 2021, 23(11): 612-614. https://doi.org/10.3760/cma.j.cn1140152021051500581
    A 25yearold male patient took about 60 tablets of phenobarbital and scopolamine hydrobromide by himself (each tablet contains 30mg phenobarbital and 0.2mg scopolamine hydrobromide). About 1 hour later, he developed coma with paroxysmal limb convulsions. Drug poisoning was diagnosed. The patient received gastric lavage, catharsis, and intravenous injection of midazolam 10mg for epilepsy. Six hours later, his heart rate was 53 beats/min, breathing rate was 11 times/min, and occasional convulsions and hematuria occurred. Laboratory tests showed indirect bilirubin 16.97μmol/L, total protein 54g/L, albumin 27.6g/L, and thrombin time 25.0s. Multiple organ injury was considered and blood purification treatment was given. One day later, the patient′s consciousness was restored, heart rate was 68 beats/min, breathing rate was 16 times/min, and no convulsion occurred. Laboratory tests showed indirect bilirubin 8.69μmol/L, total protein 54.7g/L, albumin 34.0g/L, and thrombin time 16.7s.
  • Adverse Drug Reactions Journal. 2020, 22(5): 273-279. https://doi.org/10.3760/cma.j.cn114015-20190505-00399
     A small amount of commonly used and first-aid drugs stored in the inpatient wards can facilitate the temporary treatment of patients and save precious time for the treatment of critically ill patients. But there is a risk of medication errors in the link of drug storage in the inpatient wards. In order to strengthen the management of drug storage in the inpatient wards and reduce medication errors, experts in medicine, pharmacy, nursing, hospital management, and etc., were organized by Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, Chinese Pharmacological Society Professional Committee of Drug-induced Diseases, and Adverse Drug Reactions Journal Agency, to formulate the guideline for prevention of medication errors in the link of drug storage in inpatient wards based on the Expert Consensus on Medication Error Management in China. The medication errors in the link of drug storage in the inpatient wards include improper storage of drugs, wrong drug specifications, wrong drug quantity, and wrong drug placement. The risk factors include management factors (unsound management system, no designated person or post management, or no regular inspections and supervision), process factors (no corresponding standard operation process, or only imperfect or unreasonable operation process), environmental factors (unqualified drug storage space and equipment, or no special labels), human factors (no training for personnel involved in drug use, or unreasonable staff arrangement), and drug factors (too many types and quantity of drugs in inpatient wards). The prevention strategies include technical strategies (enforcement and constraint management policies, implement of informatization and intelligence management, and formulation of standardized marks and processes, and establishment of standard catalog list and audit project list) and management strategies (establishment of management systems, provision of sufficient human resources, and enhancement of training).
  • Yu Wenjun, Qiu Cuiting, Qing Weijia, Li Na
    . 2017, 19(1): 69-71.
    A 74-year-old female patient received oral carbamazepine 0.1g thrice daily because of epilepsy after acute ischemic stroke. On the third day, the patient suddenly presented drowsiness which gradually aggravated to a state of mild coma within 30 minutes. The electrocardiogram showed that sick sinus syndrome and junctional rhythm with a heart rate of 34 beats per minute. The patient was diagnosed as Adams-Stokes syndrome which may be induced by carbamazepine. She was given an intravenous injection of atropine sulfate 0.5 mg immediately. Then atropine sulfate 1 mg in 5% glucose injection 500 ml was slowly given by intravenous drip. Two hours later, the patient regained consciousness. The electrocardiogram showed restoration of sinus rhythm with a heart rate of 48 beats per minute. Carbamazepine was withdrawn and disturbance of consciousness did not recur.
  • Du Wenjin, Zhu Rongfei
    Adverse Drug Reactions Journal. 2022, 24(10): 540-545. https://doi.org/10.3760/cma.j.cn114015-20220307-00185
    Allergic diseases have serious influence on human health and quality of life. Cytokines secreted by T-helper cell type 2 (Th2), such as interleukin (IL)-4 and IL-13, play a pivotal role in the pathogenesis of allergic diseases. By recognizing and binding to IL-4 and IL-13 receptors, dupilumab can block the signal transduction pathways of IL-4 and IL-13, inhibit Th2 inflammatory reaction, and thus play a therapeutic role in allergic diseases. At present, dupilumab has been on the market in many countries and regions around the world, yet with different indications approved, mainly including atopic dermatitis, moderate-to- severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, etc. In addition, this drug may also have better curative effect on IgE-mediated allergic reactions and other dermal diseases. Meanwhile, the safety profile of dupilumab is generally good and the common adverse reactions mainly include injection site reactions (pain, ecchymosis and swelling at the injection site), ocular diseases (conjunctivitis, keratitis, itchiness of eyes and dry eyes), oral herpes, headache, and other herpes simplex virus infections. In China, dupilumab has been approved for the treatment of moderate-to-severe atopic dermatitis in patients aged ≥6 years, showing good efficacy and no obvious safety problems.
  • Tian Danxing
    Adverse Drug Reactions Journal. 2022, 24(10): 554-556. https://doi.org/10.3760/cma.j.cn114015-20220216-00128
    A 67-year-old male patient received immunotherapy with intravenous infusion of sintili- mab 200-mg once every 3 weeks due to postoperative recurrence of liver cancer, and the efficacy and tolerance was good. After 12 doses of sintilimab treatment, the patient developed a bright red skin rashes on the chest, abdomen, and extremities with itching. Oral loratadine and topical halometasone cream were given, and the rashes were improved slightly. The rashes did not spread in the next 2 doses of sintilimab treatment. But after the 3rd dose of continuing sintilimab, the patient suddenly developed a large-area rashes all over the body, which rapidly developed into blisters, ulcers, accompanied by oozing blood and fluid on the skin, itching, and pain. Drug eruptions were diagnosed, which was considered to be induced by sintilimab. The drug was stopped. After 1 week of treatments with intravenous infusion of methylprednisolone 60-mg once daily, anti-allergy, anti-infection, mucosal protection, and skin care, the rashes were repeated. Then the dose of methylprednisolone was increased, the rashes were still not relieved 1 week later, and gastrointesting bleeding occurred. After liver cancer surgery, the patient was accompanied by hypoproteinemia, liver dysfunction, and long-term high-dose glucocorticoid use. Therefore, despite active treatment measures, the patient still died of ineffective rescue.
  • Liu Yumeng, Zhu Baoqiang, Bian Yuan, Long Enwu, Wang Guojun, Hu Jiaqiang
    Adverse Drug Reactions Journal. 2022, 24(12): 617-623. https://doi.org/10.3760/cma.j.cn114015-20220505-00395
    Objective To understand the clinical characteristics of rivaroxban- related adverse events (AE) in perioperative patients. Methods The relevant databases at home and abroad (as of April 20, 2020) were searched and the case reports of AE associated with rivaroxban used during perioperative period were collected. Relevant information in patients (nationality, gender, age, medical history, application of rivaroxaban, combined drugs, and the occurrence, treatment, and outcome of AE, etc.) was extracted and analyzed descriptively. Results A total of 42 case reports of AE caused by rivaroxban during perioperative period were collected, involving 46 patients from 11 countries. Of the 46 patients,25 (54.3%) were male and 21 (45.7%) were female with an age of 16-96 years. In terms of the reasons for medication, 34 patients used rivaroxban before operation for prevention of postoperative venous thrombosis, 7 used rivaroxban after operation for prevention atrial fibrillation, stroke, or systemic thrombosis after operation, 4 discontinued rivaroxban during perioperative period, and 1 did not explain the reason for using rivaroxban. Past medical history were described in 21 patients, including hypertension, hyperlipidemia, and diabetes, etc. Combined medication was described in 22 patients, including antibiotics, non-steroidal anti-inflammatory drugs, analgesics, cardiovascular and cerebrovascular drugs, etc. The onset time of AE was recorded in 31 patients, which was 2 hours to 2 months after medication and most within 1 month. AE associated with rivaroxban were bleeding in 29 patients, liver injury in 7 patients, anaphylaxis in 6 patients, kidney injury in 3 patients, thrombosis in 3 patients, thrombocythemia in 2 patients, thrombocytopenia, pulmonary embolism, acute attack of coronary atherosclerotic heart disease, and visual loss in 1 patient each. After the occurrence of AE, 31 patients were improved after rivaroxban withdrawn, switching to other anticoagulants, and receiving symptomatic treatment; 1 patient improved after changing concomitant medications as well as reducing the dose of rivaroxban; 2 patients did not stop the drug in time and developed new allergic reaction; 2 patients were improved after using rivaroxban again; 1 patient died of hemorrhagic shock due to gastrointestinal bleeding; 9 patients′ outcome were unknown. Among the 46 patients, 18-had medication errors, of which 16-had dose error and 2 had compatibility errors. Conclusions Hemorrhage is the most common AE related to rivaroxban in the perioperative use of rivaroxban, which mainly occurs within 1 month after medication. The overall prognosis is good after rivaroxban withdrawal, switching to other anticoagulants, and symptomatic treatment. Medication error is one of the causes of AE related to rivaroxban in perioperative period.
  • Chen Wei, Hou Shuling, Chen Pan, Dang Xueping
    Adverse Drug Reactions Journal. 2022, 24(2): 88-91. https://doi.org/10.3760/cma.j.cn114015-20210726-00826
    Immune effector cell-associated neurotoxicity syndrome (ICANS) is a common adverse reaction of chimeric antigen receptor T-cell (CAR-T) immunotherapy. Its mechanism is mainly related to the destruction of brain mural cells, increase of cytokine level, the inflammation mediated by natural killer cells, and the activation of endothelial cells. The main clinical manifestations of ICANS are aphasia, tremor, dysgraphia, drowsiness, and epilepsy. In severe cases, asphyxia, coma, or brain edema may occur, and sometimes it is even life-threatening. The factors affecting ICANS include age, peak value of CAR-T amplification, product type, and disease type, etc. American Society for Blood and Marrow Transplantation recommends symptomatic and supportive treatments for mild ICANS and hormonal shock therapy for severe cases.
  • Peng Jing, Wu Mingli, Ren Xiaolei, Jiang Kaijie, Li Lanfang, Liu Zhen, Wei Tiantian, Meng Luhua, Wang Meixia, Ban Bo
    Adverse Drug Reactions Journal. 2022, 24(3): 123-129. https://doi.org/10.3760/cma.j.cn114015-20211022-01092
    Objective To analyze the risk of diabetes mellitus related to immune checkpoint inhibitors (ICI). Methods The adverse event (AE) reports on fulminant type 1 diabetes mellitus (FT1DM), type 1 diabetes mellitus (T1DM), diabetic ketoacidosis (DKA), which were related to duvalizumab, pabolizumab, nivolumab, and atezolizumab in the US FDA Adverse Event Reporting System from the first quarter of 2004 to the second quarter of 2021, were collected.The correlation between the 4 drugs and FT1DM, T1DM,and DKA were evaluated using proportional reporting odds ratio (PRR) method.AE with reports ≥3, PRR value≥2, and χ2≥4 were judged to have statistical correlations with drugs. The greater the PRR value, the stronger the correlation between AE and drugs and the stronger the risk signals. Results A total of 1-468 AE reports on diabetes mellitus were collected, 53, 386, 957, and 72 of which were related toduvalizumab, pabolizumab, nivolumab, and atezolizumab, respectively. For duvalizumab, pabolizumab, nivolumab, and atezolizumab, the PRR reflecting the correlation with FT1DM were 21.97 (χ2=40.71), 71.50 (χ2=3-531.21), 294.30 (χ2=4-3915.75), and 33.58 (χ2=279.70), respectively; the PRR reflecting correlation with T1DM were 12.12 (χ2=162.08), 21.04 (χ2=3391.17), 20.99 (χ2=5816.11), and 9.71 (χ2=224.81), respectively; the PRR reflecting correlation with DKA were 6.93 (χ2=161.26), 4.78 (χ2=426.52), 6.82 (χ2=1797.15), and 3.04 (χ2=41.84), respectively. The 4 drugs were statistically correlated with their corresponding AE. The order of risk signal intensity for corresponding AE was FT1DM > T1DM > DKA. The order of risk signal intensity for FT1DM were nivolumab > pabolizumab > duvalizumab > atezolizumab, for T1DM were pabolizumab ≈ nivolumab > duvalizumab > atezolizumab, for DKA were duvalizumab ≈ nivolumab > pabolizumab > atezolizumab. Conclusions Duvalizumab, pabolizumab, nivolumab, and atezolizumab all can cause diabetes mellitus. The risk signal intensity was the strongest for FT1DM, followed by T1DM and DKA in order.
  • Zhao Yanhua
    Adverse Drug Reactions Journal. 2022, 24(1): 49-51. https://doi.org/10.3760/cma.j.cn114015-20210226-00237
    A 77-year-old male patient with rheumatoid arthritis was given methotrexate 10-mg once a week, tripterygium glycosides 20-mg twice daily, and methylprednisolone 8-mg once daily orally. However, the patient confused the medication frequency of methotrexate with tripterygium glycosides and mistakenly took methotrexate 5-mg twice daily. After 4 days of medication (taking methotrexate 7 times, 35-mg in total), the patient developed severe oral ulcers, generalized rash, fever, cough, and expectoration. Laboratory tests showed white blood cell count 1.21×109/L, serum creatinine 288-μmol/L, γ-glutamyl- transferase 163-U/L, alanine transaminase 82-U/L, and alkaline phosphatase 235-U/L. After 6 days of medi- cation, laboratory tests showed white blood cell count 0.13×109/L, neutrophil count 0.01×109/L, serum creatinine 317-μmol/L, estimated glomerular filtration rate 18-ml/(min·1.73 m2), C-reactive protein 233.8-mg L, and procalcitonin 14.31-μg/L. The patient was diagnosed as having methotrexate poisoning, myelosuppres- sion, renal insufficiency, and pulmonary infection. All drugs were discontinued immediately. Blood perfusion, intravenous injection of calcium folinate, and symptomatic treatments such as anti-infection, elevation of white blood cells, blood transfusion, rehydration, and mouth care were given. However, the patient′s infection and myelosuppression continued to worsen, and he died of multiple organ failure 12 days later.
  • Meng Simeng, Zhang Ling, Jiang Rong, Shao Rong
    Adverse Drug Reactions Journal. 2021, 23(11): 597-602. https://doi.org/10.3760/cma.j.cn114015-20210519-00593
    Insulin switching is very common in the treatment of diabetes mellitus, which is an important link that affects the safe use of insulin. At present, insulin switching, including selection of different insulin products, dosage adjustment, and patient education has been explained in the guidelines issued by the United States, the United Kingdom, Canada, and China. Relevant information on insulin switching is various and scattered and there is a lack of systemicity and comprehensiveness. It is suggested to refer to the guidelines of other countries, fully analyze the clinical characteristics of diabetes mellitus in China, and base on the real-world research data to formulate a systematic insulin switching guideline in line with China′s national conditions, in which the selection of insulin products, dose adjustment, patient education, dietary advice, and blood glucose monitoring, etc. can be described in detail. In addition, strengthening patient tracking and medication monitoring is also a necessary mean to ensure the safety in insulin switching.
  • Zhang Mingru, Li Guoquan, Ding Likun, Zhang Di, Ye Jiajun, Li Guiyu, Yang Weidong, Wen Aidong, Wang Jing
    Adverse Drug Reactions Journal. 2021, 23(10): 508-516. https://doi.org/10.3760/cma.j.cn114015-20210715-00792
    Objective To explore the application value of radioisotope tracer technology in clinical research of biological drugs. Methods The pharmacokinetic properties of mepuzumab in healthy volunteers were evaluated by measuring the radioactive concentrations of iodine in blood and urine samples of 3 healthy volunteers at different time points within 14 days after intravenous infusion of 131I-labeled international class I new drug mepuzumab (Trial 1). Positron emission computed tomography (PET/CT) was performed on 6 healthy volunteers after intravenous injection of 68Ga-labeled nucleic acid aptamer Sgc8, and the standard uptake values of 68Ga-Sgc8 in different organs were measured to evaluate its biodistribution in healthy humans (Trial 2). Nine patients with suspected neuroendocrine tumors underwent single photon emission and X-ray computed tomography (SPECT/CT) 4 hours after intravenous injection of 99mTc-labeled octreotide to determine the radioactive uptake level in the regions of interest; the affinity and targeting of 99mTc- labeled octreotide to somatostatin receptor subtype 2 (SSTR2) were evaluated in combination with the immunohistochemical staining results of SSTR2 in patients′ biopsy tissues (Trial 3). Results The 3 healthy volunteers included in Trial 1 were male, aged 28, 45, and 25 years respectively; the injection doses of 131I-labeled mepuzumab were 21.0, 25.9, and 17.6-mg, and the injection doses of radioactivity were 364, 420, and 304 MBq, respectively. Among the 6 healthy volunteers included in Trial 2, 3 were male and 3 were female, with an age of (46±11) years, ranging from 35 to 63 years. The dose of radioactivity injected was (80±7) MBq, ranging from 69 to 87 MBq. Among the 9 patients included in Trial 3, 5 were male and 4 were female, with an age of (54±10) years, ranging from 39 to 69 years. The dose of radioactivity injected was (777±74) MBq, ranging from 740 to 925 MBq. After intravenous infusion of 131I-labeled mepuzumab, the blood radioactivity concentration reached the peak 1.5-hours later. 131I-labeled mepuzumab mainly bound to blood cells, and its whole-blood clearance half-life was 420-hours. The urine radioactivity concentration reached the peak 16-24-hours after administration and then gradually decreased after 24-hours of administration. After intravenous injection of 68Ga-labeled Sgc8, the organs with strong to weak radioactive signals were bladder, kidney, heart, uterus, liver, spleen, gallbladder, large intestine and lung. Within 3 hours after drug administration, the clearance rate was fastest in heart, followed by uterus, kidney, and liver; the clearance rate was slower in spleen and gallbladder and were slowest in large intestine and lung. All of the 9 patients had abnormal radioactivity accumulation 4 hours after intravenous injection of 99mTc-labeled octreotide and the immunohistochemical staining results of biopsy tissues showed strong positive expression of SSTR2, indicating that 99mTc-labeled octreotide had good affinity and targeting to SSTR2. The safety evaluation showed that in Trail 1, one subject developed iodine-related hyperthyroidism one month after intravenously infusion of 131I-labeled mepuzumab, which returned to normal after 8 months of continuous monitoring without intervention. No adverse reactions occurred in other subjects. Conclusions Radioisotope tracer tech- nology can noninvasively, dynamically, and visually evaluate the pharmacokinetics, biological distribution, and targeting of biological drugs in human body. It has good safety and great application value in the clinical evaluation of biological drugs.
  • Adverse Drug Reactions Journal. 2023, 25(7): 389-397. https://doi.org/10.3760/cma.j.cn114015-20230608-00421
    In 2022, a total of 22-868 cases of medication error (ME) from 315-hospitals in 26 provincial administrative regions were collected in the National Monitoring Network for Clinical Safe Medication. The number of hospitals reporting ME increased by 14.55% compared with that in 2021 (275-hospitals), and the number of reported ME cases increased by 16.76% compared with that in 2021 (19-585 cases). In 22-868 cases of ME reports, 155 (0.68%) were classified as grade A, 18-981 (83.00%) as grade B, 3-076 (13.45%) as grade C, 422 (1.85%) as grade D, 75 (0.33%) as grade E, 156 (0.68%) as grade F, 1 (<0.01%) as grade G, and 2 (0.01%) as grade H; no MEs of grade I occurred. Among the 22-713 patients involved in MEs of grade B to I, 12-668 (55.77%) were male and 10-045 (44.23%) were female; their ages were from 1 day to 102 years; 2-453 (10.80%) were children (<18 years old), 11-374 (50.08%) were young and middle-aged adults (≥18 to <60 years old), and 8-886 (39.12%) were elderly (≥60 years old). A total of 234 patients were involved in serious MEs (grade E-I), including 134 (57.27%) males and 100 (42.73%) females, aged from 4 days to 94 years, of which 37 (15.81%) were children, 83 (35.47%) were young and middle-aged adults, 114(48.72%) were elderly. The serious MEs (grade E-I) mainly occurred in the administration link [74.36% (174/234)]. The 155 grade A MEs did not involve person who triggered the ME and place where ME occurred. Among the 22-713 grade B-I MEs, 17-102 (75.30%) were triggered by physicians, 4-072 (17.93%) by pharmacists, 764 (3.36%) by nurses, 461 (2.03%) by patients and their family members, and 314 (1.38%) by other persons; the proportion of MEs triggered by physicians increased year by year for 4 consecutive years; the triggers of serious MEs were mainly patients and their family members [61.97% (145/234)]. Among these MEs, 9-238 (40.67%) occurred in clinics, 7-183 (31.63%) in hospital wards, 4-620 (20.34%) in pharmacies, 1-063 (4.68%) in pharmacy intravenous admixture services, 213 (0.94%) in the nurse stations, 321 (1.41%) in patients′ home, 6 (0.03%) in the community health service stations, and 69 (0.30%) in other places. Among the 234-severe MEs, 129 (55.13%) occurred in the patient′s home, and the proportions of MEs and serious MEs occurred in the home increased year by year for 4 consecutive years. The top 3 contents of ME were wrong drug class (4-285, 18.40%), wrong dosage (4-115, 17.67%), and wrong administration frequency (2-808, 12.06%). The top 3 persons who discovered the ME were pharmacists (17-575, 74.74%), patients and their family members (2-654, 11.29%), and physicians (1-752, 7.45%). The top 3 factors causing ME were lack of related pharmacologic knowledge (8-665, 31.94%), tiredness (4-249, 15.66%), and insufficient training of medical workers (3-502, 12.91%).
  • Song Jiawei, Wang Lu, Chen Huijuan, Liu Li, Wang Qiangqiang, Wu Wei
    Adverse Drug Reactions Journal. 2021, 23(3): 165-166. https://doi.org/10.3760/cma.j.cn114015-20201030-01098
    A 77-year-old female patient was given combined chemotherapy with paclitaxel for injection (albumin bound) and nedaplatin for ovarian malignant tumor with peritoneal metastasis. When paclitaxel for injection (albumin bound) 100-mg dissolved in 0.9% sodium chloride injection 250-ml was given intravenously for the first time, the infusion was not smooth and the drip rate was slow. After stopping infusion, the infusion device was checked and white flocculent sediment above the filter was found. Clinical pharmacists ruled out the possibility of precipitation caused by drug preparation and incompatibility contraindications, and found that the infusion device used by this patient was a precision one (the pore diameter of microporous filter was 5-μm). However, in the drug label of paclitaxel for injection (albumin bound), it was pointed out that "Use of filters with a pore size less than 15-μm may result in blockage of the filter and should not be used." On the second day, a general infusion device (filter with 20-μm pore size) was used for IV infusion of paclitaxel for injection (albumin bound) and the process was smooth and no blockage recurred.
  • Li Jiale, Li Haipian, Huang Zhaoqi, Mo Xiaolan
    Adverse Drug Reactions Journal. 2022, 24(10): 508-514. https://doi.org/10.3760/cma.j.cn114015-20220503-00388
    Objective To explore the efficacy and safety of crisaborole ointment (crisaborole) treatment in children with atopic dermatitis (AD). Methods PubMed, Embase, Medline, CNKI, Wanfang Medicine, VIP, and Chinese Medical Journal Databases were searched (up to March 2022) and the literature on randomized controlled trials (RCTs) and cohort studies of crisaborole treatment in children with AD was collected. The quality of RCTs and cohort studies was evaluated using the modified Jadad scale and Newcastle- Ottawa scale, respectively. Data on effective rate and incidence of adverse event in children treated with crisaborole were extracted. The meta-analysis of single proportions was performed with Stata 15-software. Results A total of 8 studies (4 RCTs and 4 prospective cohort studies, respectively) were entered in the analysis, including 1-855 children (aged from 3 months to 17 years) treated with crisaborole. The 8 studies were all of high quality. The meta-analysis of single proportions showed that the effective rate of children with AD treated with crisaborole for 14-28 days was 46% [95% confidence interval (CI): 32%-61%], the incidence of adverse events during treatment was 28% (95%CI: 19%-38%), and the incidence of treatment discontinuation due to adverse events was 1% (95%CI: 0-2%). Most of the adverse events caused by crisaborole were local skin reactions, mainly characterized by local pain, itching, dermatitis, paresthesia, and local infection, etc. Seven of the 8 studies reported the pain at the application site, and the incidence of pain at the application site was 17% (95%CI: 11%-24%). Most adverse events were mild to moderate and could be alleviated without treatment. Serious adverse events occurred in 8 patients (0.4%), 7 of which were unrelated to the treatment drugs. Conclusion Crisaborole has good efficacy and safety in the treatment of mild to moderate AD in children.
  • Ren Xiuhua, Yu Hengyi, Fang Yinian, Zhang Donglin, Chen Qian,
    Adverse Drug Reactions Journal. 2022, 24(6): 300-307. https://doi.org/10.3760/cma.j.cn114015-20220218-00138
    Objective To compare the pharmacokinetics and safety of single intravenous injection of the generic bevacizumab injection WBP264 and the original bevacizumab injection Avastin- in healthy male volunteers. Methods The study was designed as a randomized, double-blind, single dose, parallel, and controlled phase I clinical trial. Healthy male volunteers who were recruited publicly were randomized into the trial group (intravenous infusion of WBP264) and the control group (intravenous infusion of Avastin-), and the dose was 3-mg/kg. Peripheral venous blood was collected within 30-minutes before administration, 45-minutes after onset of the administration, immediately after finishing the administration, 2.5, 3.5, 5.5, 9.5, 13.5, 24, 48-hours and on the 5th, 8th, 15th, 22nd, 29th, 36th, 43rd, 57th, 71st, 85th, and 99th days after the administration. The plasma concentration was measured by enzyme-linked immunosorbent assay, the plasma concentration-time curve and its semilogarithmic plot were plotted, and the pharmacokinetic parameters such as the area under the plasma concentration-time curve [including AUC from time zero to the time of the last quantifiable concentration (AUC0-t) and AUC from time zero to infinity (AUC0-∞)], peak concentration (Cmax), time to peak (Tmax), plasma elimination half-life (t1/2), clearance rate (CL), and apparent volume of distribution (Vd) were calculated. When the 90% confidence intervals (CI) of the geometric mean ratio of AUC0-t, AUC0-∞, and Cmax between the trial group and the control group were between 0.80-1.25, it indicated that pharmacokinetics of WBP264 and Avastin- were similar. The physical examination, vital signs detection, electrocardiogram, and laboratory tests were performed on the subjects, the occurrence of adverse events (AEs) and the severity classification were recorded, and correlation between the AEs and the trial drug was evaluated. The anti-drug antibody and its neutralizing antibody were detected before administration and on the 8th, 15th, 29th, 43rd, 71st, and 99th days after administration to evaluate the immunogenicity of the drug. Results A total of 78-subjects were recruited, 39 in the trial group and 39 in the control group. In the trial group, 2 cases withdrew from the trial (1 case did not take the drug and 1 case withdrew for personal reason after taking the drug). Seventy-seven cases were in the safety analysis set and 76 cases in the pharmacokinetic analysis set. The differences in age, height, weight, and body mass index between the 2 groups were not significant (all P>0.05). The plasma concentration-time curves of bevacizumab between the trial group and the control group were similar. The geometric mean ratios (90%CI) of AUC0-t, AUC0-∞, and Cmax were 1.04 (0.98-1.10), 1.03 (0.98-1.10), and 1.09 (1.03-1.14), respectively. The differences in the incidence of overall AEs [89.5% (34/38) vs. 87.2% (34/39)] and the incidence of AEs possibly related to the trial drug [86.8% (33/38) vs. 79.5% (31/39)] between the trial group and the control group were not significant (all P>0.05). Only one case of AE in the trial group was grade 3 in severity and was assessed as being not related to the drug, and the rest were grade 1-2, with grade 1 AEs accounting for the vast majority. The difference in the positive rate of anti-drug antibody between the trial group and the control group was not significant [10.5% (4/38) vs. 10.3% (4/39), P>0.05]. The neutralizing antibody test was negative in the patients with positive anti-drug antibody. Conclusion The pharmacokinetics and safety of WBP264 and Avastin- are similar.
  • Cai Jun, Li Huixin, Nie Li, Han Dan, Zhang Jinping
    Adverse Drug Reactions Journal. 2021, 23(12): 644-648. https://doi.org/10.3760/cma.j.cn114015-20211201-01211
    Medication rationality index (MAI) scale sets up 10 items to evaluate the rationality of prescription medication, including indication, effectiveness, dosage, correct direction, practical direction, drug-drug interaction, drug-disease interaction, duplication, duration, and cost. MAI scale has good reliability, which can be used to evaluate the rationality of drug use and the non-essential drug use, the potential inappropriate medication in elderly patients, verify the reliability and effect of irrational drug use detection software, quantify clinical intervention measures, and predict adverse events and quality of life. Since MAI scale application involves subjective judgment, evaluators should be trained before use.
  • Peng Jing, Jiang Kaijie, Ren Xiaolei, Wu Mingli, Zhao Yanyan, Wang Meixia, Meng Luhua, Liu Zhen, Wang L
    Adverse Drug Reactions Journal. 2022, 24(2): 67-73. https://doi.org/10.3760/cma.j.cn114015-20210813-00897
    Objective To understand the main adverse event (AE) related to denosumab and the risks and provide reference for the safe use of the drug in clinic. Methods The AE reports on denosumab included in the US FDA Adverse Event Reporting System from the second quarter of 2010 to the first quarter of 2021 were collected, and the AE risk signals was explored using proportional reporting odds ratio (PRR) method. AEs with ≥3 reports, PRR value ≥2, and χ2≥4 were defined as positive risk signals. AEs were counted and classified using the preferred system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities 24.0. The PTs of top 50 adverse event reports and signal intensity were selected and analyzed. Results A total of 132-764 AE reports with denosumab as the primary suspected drug were collected, involving 5-571 PTs, and 641 positive risk signals were selected. After the second screening, the top 50 PTs in the number of AE reports and the top 50 PTs with great PRR values were obtained, and 93 PTs were included in the analysis after sifting out the repeated, involving 114-617 AE reports. The top 5 PTs in the number of AE reports were off-label use (28.7%, 32-863/114-617), death (14.2%, 16-230/114-617), osteonecrosis of the jaw (6.0%, 6-861/114-617), arthralgia (4.7%, 5-420/114-617), and limb pain (4.1%, 4-727/114-617). The top 5 PTs with the high signal intensity were giant-cell tumour of bone (PRR=402.7), malignant giant-cell tumour of bone (PRR=325.2), C-telopeptide increase (PRR=169.4), exostosis of jaw (PRR=163.2), and ionised calcium abnormal (PRR=158.1). The top 5 SOC involving AE reports were injury, poisoning and procedural complications (35.9%, 41-757/114-617), musculoskeletal and connective tissue disorders (32.7%, 37-455/114-617), general disorders and administration site conditions (18.2%, 20-814/114-617), surgical and medical procedures (4.1%, 4-744/114-617), and investigations (2.9%, 3-290/114-617). Forty-four PTs were not included in the drug instructions, of which 23 were related to the oral cavity. Conclusions Denosumab AE with the most reports were off-label use and osteonecrosis of the jaw. The risk signals of osteonecrosis of the jaw and recurrence or deterioration of giant-cell tumor of bone was strong. Most of the AE risk signals that were not included in the instructions are oral problems.
  • Zhao Bin
    Adverse Drug Reactions Journal. 2023, 25(8): 449-453. https://doi.org/10.3760/cma.j.cn114015-20230628-00478
    Signal detection of adverse drug reaction (ADR) is an important research method in post marketing pharmacovigilance. In recent years, the number of literature on ADR signal detection in China has increased significantly. However, there are still many problems in this kind of research, such as unclear understanding of the concept of ADR signal, unclear purpose of signal detection research, limited signal source, inadequate processing of data in detection, unduly single data mining algorithm, unduly short time period in data selection, and no processing and analysis on bias in signal detection. This paper provides some views on these common problems in order to improve the quality of ADR signal detection research in China.
  • Gu Zhongsheng, Ji Chunmei
    Adverse Drug Reactions Journal. 2022, 24(12): 647-651. https://doi.org/10.3760/cma.j.cn114015-20220407-00296
    Objective To explore the adverse reaction risk signals of perampanel-related psychia- tric disorders, and provide reference for the clinical safe application of perampanel. Methods The US FDA Adverse Event Reporting System database was searched, and the adverse event (AE) reports on psy- chiatric disorders from the third quarter of 2012 to the third quarter of 2021, which judged perampanel as the primary suspect drug were collected. The expression of AE was standardized using the preferred term (PT) in the Medical Dictionary for Regulatory Activities. Data such as patient general condition and psychiatric AE outcomes was extracted from AE reports and was analyzed descriptively. Risk signal mining for psychiatric adverse reactions to perampanel was performed using the reporting odds ratio (ROR) method. The positive signal PT was set as that the number of AE reports was 3 and more and the lower limit of the 95% confidence interval (CI) of the ROR was greater than 1. Results A total of 922 reports on psychiatric AE with perampanel as the primary suspect drug were collected. Of the 922 patients involved, 439 were male, 441 were female, and 42 were unknown in gender. Age were recorded in 676 patients, and the age was (38±19) years. AE outcomes were recorded in 807 patients, of which hospitalization/prolonged hospitalization, urgent treatment needs, life threatening, and death due to AE occurred respectively in 409 (44.4%), 316 (34.3%), 60 (6.5%) and 22 patients (2.4%). The 922 AEs involved 1-580 PTs, and 46 PTs were detected with positive signals by ROR method. The top 5 PTs mostly reported were aggression (286 AEs), irritability (128 AEs), suicidal ideation (110 AEs), suicide attempt (100 AEs), and anger (77 AEs). The top 5 PTs with strongest signal intensity (ROR value) were postictal psychosis (383.13), schizophreniform disorder (355.27), homicidal ideation (203.56), dissociative disorder (119.64) and delusional perception (108.34), among which dissociative disorder and postictal psychosis were AEs not recorded in the drug labels. In the 46 PTs with positive signal, 14 (30.4%) were not recorded in the drug labels, and the other 12 PTs were listed as sexually inappropriate behaviour (81.43), suspiciousness (65.20), disinhibition (32.72), impulsive behaviour (31.18), perso- nality change (22.56), abnormal behaviour (16.31), social avoidant behaviour (12.95), restlessness (6.15), bipolar disorder (5.23), affect lability (5.09), nightmare es (2.86), and fear (2.79). Conclusion psychiatric adverse reaction is a common and serious adverse reaction of perampanel, which should be paid attention to clinically.
  • Gao Yiling, Zhu Minghui, Tang Qiaoyun, Ni Tong, Wang Lin, Ma Jing
    Adverse Drug Reactions Journal. 2021, 23(7): 387-389. https://doi.org/10.3760/cma.j.cn114015-20201207-01218
    A 38-year-old female patient with recurrence of breast cancer accompanied by liver metastasis received intravenous infusion of sintilimab 200-mg on the first day and 21 days was a cycle. Before the immunotherapy, her function of liver, kidney, and thyroid was normal. Three days after the medication, the patient developed rash and itching on skin of waist. After that, diffuse erythema and desquamation appeared on skin of her whole body and blisters appeared on both upper limbs and back. At the same time, she developed blurred vision, increased eye secretions, and foreign-body sensation. Laboratory tests showed alanine aminotransferase (ALT) 123-U/L, aspartate aminotransferase (AST) 342 UL, γ-Glutamyltransferase (γ-GT) 907-U/L, alkaline phosphatase (ALP) 424-U/L, serum creatinine (Scr) 95.6-μmol/L, uric acid 691.0-μmol/L, and thyroid-stimulating hormone (TSH) 20.87 mU/L. She was diagnosed with rash, hypothy- roidism, kidney injury, conjunctivitis, and liver injury, which were considered to be associated with sintilimab. After 16 days of symptomatic treatments such as IV infusions of methylprednisolone sodium succinate for injection and magnesium isoglycyrrhizinate injection, oral administration of levothyroxine sodium and Haikun Shenxi capsules (海昆肾喜胶囊), levofloxacin eye drops, and skin care, her rash was subsided, blisters were absorbed, and the discomfort in the eyes disappeared. Laboratory tests showed ALT 111 UL, AST 122-U/L, γ-GT 1-430-U/L, ALP 321-U/L, Scr 56.0-μmol/L, uric acid 243.0-μmol/L, and TSH 13.60 mU/L.
  • 安全用药
    . 2003, 5(4): 241-245.
    近年,甘露醇静脉及口服给药的不良反多有报告,其中过敏反应较为常见,严重者可发生过敏性休克。还可致肾损害、心血管系统损害、肺水肿、中枢神经系统反应等严重不良反应,本文仅对近五年来甘露醇应用时有关不良反应的文献进行回顾,探讨导致不良反应的相关因素,以期引起临床工作者的注意。
  • Li Shanshan, Xu Xiaohan, Wu Ziyang, Zhai Suodi, Wen Jian, Cheng Yinchu
    Adverse Drug Reactions Journal. 2022, 24(12): 624-632. https://doi.org/10.3760/cma.j.cn114015-20220602-00489
    Objective To systematically evaluate the occurrence of interstitial lung disease (ILD) in patients with non-small cell lung cancer (NSCLC) treated with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI). Methods PubMed, Embase, The Cochrane Library, CNKI, WanFang, and VIP databases were searched up to April 30, 2022. Randomized controlled trials (RCT) about NSCLC treated with EGFR-TKI (8 kinds listed in China, including gefitinib, erlotinib, icotinib, afatinib, dacomitinib, osimertinib, almonertinib, and furmonertinib) compared with chemotherapy were collected. Patients was treated with EGFR-TKI monotherapy in the trial group and chemotherapy in the control group. The outcomes included the occurrence of ILD. RevMan 5.4-software was used for meta-analysis, and the effect sizes were odds ratio (OR) and the 95% confidence interval (CI). Results A total of 15 RCT were entered in the analysis, including 6 about gefitinib, 5 about erlotinib, 2 about icotinib, and 2 about afatinib, involving 2-318 patients in the trial group and 1-975 in the control group. Meta-analysis showed that the overall incidence of ILD in the trial group were higher than that in the control group [1.47% (34/2-318) vs. 0.51% (10/1-975), OR=2.44, P=0.004]; difference in incidences of ILD-related death between the 2 groups was not significant [0.35% (8/2-318) vs. 0.05% (1/1-975), OR=3.29, P=0.07]. The severity of ILD was graded in 14 RCT, and the meta-analysis showed that the incidence of more than grade 3 ILD in the trial group was higher than that in the control group [0.62%(13/2-089) vs. 0.11% (2/1-864), OR=2.60, P=0.04]. The overall incidences of ILD and the incidences of more than grade 3 ILD in the gefitinib group were higher than those in the corresponding control groups [2.31%(27/1-167) vs. 0.71% (8/1-123), OR=2.88, P=0.004; 0.86% (7/1-167) vs. 0.09% (1/1-123), OR=3.98, P=0.03]. There was no significant difference in ILD occurrence between the trial group and the control group for afatinib and erlotinib (all P>0.05). No ILD occurred in the trail group or in the control group in RCT about icotinib. Conclusions Compared with chemotherapy, NSCLC patients receiving EGFR-TKI, especially gefitinib, have higher risks of ILD and serious ILD. Therefore, clinical vigilance and monitoring should be strengthened.
  • Chen Yan, Guo Yuhang, Guo Jinmin
    Adverse Drug Reactions Journal. 2023, 25(6): 352-358. https://doi.org/10.3760/cma.j.cn114015-20220324-00238-1
    Objective To mine risk signals related to tafamidis, which was a rare disease drug and newly included in the medical insurance list. Methods The drug-related adverse event (AE) reports from the 1st quarter of 2013 to the 2nd quarter of 2022 were searched based on the US FDA Adverse Event Reporting System and AE reports with tafamidis as the primary suspect drug were extracted. The report odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method were used to detect the AE risk signals of tafamidis. A target AE with reports ≥3 and 95% confidence interval (CI) lower limit of ROR>1 was defined as a positive signal for ROR method and the larger the ROR and its lower limit of 95%CI, the stronger the signal strength. The information component (IC)-2SD>0 (SD is the standard deviation) was defined as a positive signal for BCPNN method, and the larger the IC-2SD value, the stronger the signal. According to the preferred system organ class (SOC) and preferred term (PT) from terminology of adverse drug reactions in Medical Dictionary for Regulatory Activities, AEs were counted and classified. The risk signal with positive detection results from both ROR and BCPNN methods was determined as the AE risk signal of tafamidis and analyzed. Results A total of 3-999 cases with tafamidis as the primary suspect drug were collected, including 2-942 males (73.6%), 688 females (17.2%), and 369 unknown cases (9.2%); 3-148 cases (78.7%) aged >65 years, 192 cases (4.8%) aged 18-65 years, 52 cases (1.3%) aged <18 years, and 607 cases (15.2%) were unknown; 1-064 patients were with cardiac amyloidosis, 872 patients with cardiac amyloidosis, 148 patients with peripheral nerve amyloidosis, and 176 with other diseases; 1-403 cases (35.1%) died. A total of 110 positive signals were screened with both ROR and BCPNN methods, involving 20 SOCs. The top 5 PTs of AE reports were dyspnea (338 cases), fatigue (301 cases), edema (167 cases), dizziness (111 cases), and fall (110 cases). The SOC involved were systemic lesions, neurological diseases, respiratory/thoracic and mediastinal diseases, examination, metabolic and nutritional diseases. The top 5 PTs (ROR and the 95%CI lower limit) were early feeling of fullness (28.07,11.64), lumbar spinal stenosis (26.73,15.15), aortectasia (24.36,9.11), hypoxia (22.64,10.15), and cervical radiculopathy (22.13,7.11). Four of the top 20 PTs in the AE reports were not recorded in the drug label, including dizziness, height loss, chest pain, and renal failure; 16 of the top 20 PTs in signal strength (ROR method) were not recorded in the drug label, including lumbar spinal stenosis, aortic dilatation, physical decline, cervical radiculopathy, height reduction, carotid artery disease, hyperlipidemia, orthopnea, peripheral vein disease, benign prostatic hyperplasia, carpal tunnel syndrome, emaciation, foreign body sensation in the throat, immune thrombocytopenia, positional dizziness, and aortic atherosclerosis. Conclusion Through data mining, it is found that early feeling of fullness, lumbar spinal stenosis, aortic dilatation, physical decline, and cervical radiculopathy may be the common adverse events of tafamidis, some risk signals are not recorded in the drug label, which should be paid attention to during the clinical use.
  • Wang Yu, Li Jia, Pan Yunyan, Zheng Yifan, Chen Pan, Chen Jie
    Adverse Drug Reactions Journal. 2022, 24(7): 347-352. https://doi.org/10.3760/cma.j.cn114015-20220515-00427
    Objective To explore the risk signals of edoxaban-related adverse reactions and provide reference for the clinical safety of edoxaban. Method The US FDA adverse Event Reporting System database was searched and the adverse event (AE) reports on edoxaban as the suspicious drug from the second quarter of 2011 to the first quarter of 2022 were collected. An AE with reports>3, 95% confidence interval (CI) lower limit of ROR>1, PRR>2, and χ2>4 was defined as a positive signal. AEs were counted and classified using the preferred term (PT) and system organ class of Medical Dictionary for Regulatory Activities 25.0. The PTs of top 50 in AE report amount and signal intensity were selected and analyzed. Results A total of 4-113 AE reports on edoxaban as the suspicious drug were collected and 996 PTs were involved. After calculation using ROR and PRR methods, 158 positive risk signals were obtained, involving 1-898 AE reports. PTs of the top 50 in AE report amount and signal intensity were merged 89 PTs were selected after screening out duplicates, involving 1-468 AE reports. The top 5 PTs in report amount were dyspnea, anemia, atrial fibrillation, melena, and cardiac failure; the top 5 PTs in signal intensity were angiodysplasia, urogenital haemorrhage, cardiac amyloidosis, chorea, and ischaemic cerebral infarction/cardioac- tive drug level increased. Fourty-five PTs were not included in the drug labels. Of them, acute renal injury, renal impairment, and interstitial lung disease were with more AE reports and stronger signals. Conclusions Bleeding-related events are still the key AEs that need to be monitored during the use of edoxaban. Edoxaban may also lead to renal injury and interstitial lung disease, which requires special attention.
  • Liu Yinyin, Li Fan, Fan Zhaopu, Huo Yalan
    Adverse Drug Reactions Journal. 2020, 22(7): 424-425. https://doi.org/10.3760/cma.j.cn114015-20190123-00081
    A 50-year-old male patient grinded his self-purchased blister-beetle (Mylabris) body into powder and then made it into paste for large area external use on his body skin for psoriasis. A few minutes later, the patient developed erythema and blisters on the site of medication; a few hours later, the purplish-red patches and blisters spread throughout the body, epidermis relaxed and exfoliated, and symptoms of systemic poisoning appeared. One day later, the patient developed multiple organ failure, such as respiratory failure, liver injury, kidney injury, severe hypoproteinemia, and abnormal coagulation function. Epidermolysis bullosa induced by externally application of Mylabris was diagnosed, and treatments of high-doses of pulsetherapy methylprednisolone, intravenous infusions of human immunoglobulin and human albumin, bedside hemofiltration, ventilator-assisted ventilation, and etc. were given. However, the patient′s condition deteriorated rapidly and finally he died of multiple organ failure 12-hours later.
  • Bian Yicong, Miao Liyan, Zhao Limei
    Adverse Drug Reactions Journal. 2022, 24(11): 599-603. https://doi.org/10.3760/cma.j.cn114015-20220517-00439
    Reactive metabolites is one of the main causes of drug-induced liver injury (DILI). After entering the body, some drugs can be metabolized by liver to generate drug reactive metabolites, which can deplete glutathione, and in turn bind to macromolecules such as proteins or nucleic acids in the body, alter biomacromolecule function, induce cellular oxidative stress and the body′s immune response, interfere with the body′s normal physiological function, and produce hepatotoxicity. Reactive metabolites mediated DILI may be not the action of one mechanism, but the combined effects of multiple mechanisms. This article reviews the production process of drug reactive metabolites, the mechanism of liver injury, and the means of prevention and treatment, providing an important reference for clinical safe drug use.
  • Zhou Zhangjiuzhi, Ma Leping, Zhang Wei, Li Zhaoxue
    Adverse Drug Reactions Journal. 2023, 25(3): 165-171. https://doi.org/10.3760/cma.j.cn114015-20221008-00893
    Objective To explore the adverse event (AE) risk signals of romiplostim, and provide reference for the safe use of the drug in clinic. Methods The adverse event reports on romiplostim included in the US FDA Adverse Event Reporting System from the first quarter of 2008 to the second quarter of 2022 were collected. AEs were standardized using preferred term (PT) in the Medical Dictionary for Regulatory Activities. The general situation of patients and the outcome of AEs were extracted from the AE reports and analyzed descriptively and statistically. The AE risk signals of romiplostim was explored using the reporting odds ratio (ROR) method and the proportional reporting odds ratio (PRR) method. The positive signal PT was set as that the number of AE reports was 3 and more and the lower limit of the 95% confidence interval (CI) of the ROR and PRR were greater than 1. Results A total of 12-222 AE reports with romiplostim as the primary suspected drug were collected. Among the 12-222 patients involved, 10-295-had gender records, including 4-818 males and 5-477 females; 3-789 patients with age records, ranging from 0 to 98 years, with an average age of 58 years; 5-919 patients with AE outcome records, the patient number of hospitalizations, death, life-threatening, disabling, and congenital malformation due to AEs were 3-092, 2-305, 363, 152, and 7, respectively. Twelve thousand two hundred and twenty-two AE reports involved 2-090 PTs,which occurred 20-639 times. Signal mining was performed on the top 100 PTs in the number of reports and 42 positive signals were detected. The top 5 PTs in the number of AE reports were decreased platelet count (PLT) (1-510 patients), lack of efficacy (1-488 patients), decreased efficacy (921 patients), abnormal PLT (857 patients), and death (853 patients). The PTs with signal intensity ranking in the top 5 were bone marrow reticulin fibrosis (ROR=631.43, PRR=341.43), abnormal bone marrow biopsy (ROR=202.73, PRR=159.36), abnormal platelet count (ROR=200.90, PRR=159.49), splenectomy (ROR=118.82, PRR=102.55) and thrombocytosis (ROR=84.66, PRR=76.14). There were 10 PTs not recorded in the drug instruction, whose signal intensity from high to low in the order were splenectomy, chronic lymphocytic leukemia, hemolysis, hospitalization, pleural effusion, sepsis, bone pain, off-label drug use, hemoglobin reduction, and migraine. Conclusions Bone marrow reticulin fibrosis and abnormal platelet count, as well as the resulting bleeding and thrombotic complications, are the AEs that need to be monitored during the use of romiplostim. Among the 10 PTs not recorded in the drug instruction, pleural effusion and sepsis need to be noticed.
  • Huang Xiaofang, Gong Lixian, Deng Minjia, Yang Chen
    Adverse Drug Reactions Journal. 2020, 22(5): 326-327.
    An 87-year-old female patient with hypertension was given 3 Suhuang Zhike capsules (0.45 g/capsule) for cough. Half an hour after medication, the patient suddenly developed limbs tremor, accompanied by palpitation and sweating. The symptoms lasted for about 10-minutes and relieved spontaneously. Her blood pressure was 145/79-mmHg. Her nervous system examination showed no abnormality; blood glucose, electrolyte, thyroid function, and liver and kidney function were all normal; and electroencephalogram and cranial computed tomography showed no obvious abnormality. Ephedrine in Suhuang Zhike capsules was considered to be related to her symptoms. The drug was stopped and oral alprazolam 0.4-mg was given twice daily. The symptoms of limbs tremor did not recur in the patient.
  • Guan Yue, Mu Fei, Zhang Wei, Qiao Yi, Wang Congcong, Chen Sunin, Guo Guiping, Wang Jingwen
    Adverse Drug Reactions Journal. 2021, 23(7): 342-347.
    Benifits outweigh the risks for patients with autoimmune disease (AID) in remission period to be vaccinated with coronavirus disease 2019 (COVID-19) vaccines. The mRNA vaccines, inactivated vaccines, and recombinant protein subunit vaccines are safe for AID patients, whereas the safety of recombinant adenovirus vector-based vaccines is still uncertain. Some drugs for the treatment of AID may reduce the immune response of the body to the COVID-19 vaccines and affect the immune efficacy of the vaccine, which may be related to the timing of vaccination. Based on several published relevant guidelines and recommendations for the COVID-19 vaccines in AID patients, this article elaborates on vaccination problems to be paid attention to in patients with AID treated with different drugs.
  • Shu Wenlin, Chen Shuifang
    Adverse Drug Reactions Journal. 2020, 22(12): 701-702. https://doi.org/10.3760/cma.j.cn114015-20200224-00159
    A 4 years and 7 months old boy was treated with IV infusions of azithromycin 0.16 g once daily and methylprednisolone sodium succinate 32-mg once daily and oral amoxicillin and clavulanate potassium for suspension 228.5-mg twice daily for bronchopneumonia complicated with multiple co-infections with mycoplasma, viruses, and bacteria. After 6 days of treatments, the boy′s symptoms were improved and his body temperature returned to normal. On the 7th day of treatments, the boy developed rash with itching, which subsided on the same day after symptomatic treatments. Amoxicillin and clavulanate potassium and azithromycin were discontinued, but the child still developed rash every time after IV infusion of methylprednisolone sodium succinate, which could subside later that day. After withdrawal of methylprednisolone sodium succinate, the boy′s rash did not recur.
  • Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, Chinese Pharmacological Society Professional Committee of Drug-induced Diseases, Adverse Drug Reacti
    Adverse Drug Reactions Journal. 2020, 22(1): 6-11. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.01.003
    Barcode technology is a kind of automatic recognition technology which is produced and developed in computer application and practice. Barcode technology has been widely used in drug purchase, management, dispensing, use and other aspects, and plays an important role in reducing human errors, improving work efficiency, and reducing medication errors in drug information check, information matching of drug and patient, and other important links. However, barcode technology can also lead to medication errors due to human operation, technical level, and other factors during application. In order to strengthen the prevention of medication errors related to the application of drug barcode technology in medical institutions, experts in pharmaceutical, nursing, informational, and management, who were organized by Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, Chinese Pharmacological Society Professional Committee of Drug-induced Diseases, and Adverse Drug Reactions Journal Agency, formulate the guideline for prevention of medication errors in application of barcode technology in medical institutions after several argumentation based on the Expert Consensus on Medication Error Management in China. The medication errors related to drug barcode technology may occurred in links of drug storage and delivery, drug dispensing and distribution, intravenous drug admixture, inpatient drug administration, and etc. The risk factors include systematic factors (damaged barcode quality, poor barcode printing quality, scanning and printing equipment problems, packaging problems, system defects, and sharing difficulties of internal barcode information) and human factors (barcode information maintenance error, not timely information update, wrong pasted barcode, too little internal barcode information, operation error, and improper implementation). The prevention strategies for medication errors related to drug barcode application include technical strategies (including enforcement and constraint policies, automation and information, establishment of good checking system) and management strategies (including regulatory framework, environment and personnel). The guideline is formulated for all medical staff involved in the application and management of drug barcode technology in medical institutions.
  • Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, Chinese Pharmacological Society Professional Committee of Drug-induced Diseases, et al
    Adverse Drug Reactions Journal. 2021, 23(8): 396-402. https://doi.org/10.3760/cma.j.cn114015-20210712-00785
    There are risks of medication error in the whole process of drug use and management in the operating room. The types of medication errors in operating room include prescription issuing/doctor′s order giving error, prescription/doctor′s order delivery error, drug dispensing error, labeling error, preparation error, drug application technology error, drug monitoring error, drug storage error, essential drug setting error, etc. The risk factors of medication errors in the operation room mainly exist in the links of prescription issuing and delivery, drug dispensing and distribution, drug administration and monitoring, drug management, etc. The prevention strategies of medication errors in operating room include technical strategies (mandatory and constraint strategies, implementation of automation and computerization, development of standardized identifiers and processes, establishment of audit project lists) and management strategies (recommending the management mode of operation pharmacy, increasing the support of clinical pharmacy, storing drugs in different areas in operation room, allocating human resources reasonably, standardizing management of drug maintenance, advocating safe drug use culture, and strengthening professional skills training based on post competency). This guideline is applicable to all personnel involved in the use and management of drugs in the operating room.
  • Ding Qian, Zhang Qingxia, Yan Suying
    Adverse Drug Reactions Journal. 2021, 23(12): 633-638. https://doi.org/10.3760/cma.j.cn114015-20210304-00264
    Objective To explore the clinical characteristics of dabigatran etexilate-related serious adverse events(AE). Methods Databases of CNKI, WanFang, PubMed, and Embase were searched as of October 31, 2020 and case reports on serious AE related to dabigatran etexilate were collected. Relevant information in patients (nationality, gender, age, weight, application of dabigatran etexilate, co-existing diseases and combined drugs, the occurrence, treatment and outcome of AE, etc.) was extracted and analyzed descriptively. Results A total of 77 literature were included, involving 101 patients from 20 countries. There were 64 males (63.4%) and 37 females (36.6%), aged 56-94 years with the body weight of 38-193-kg. In terms of the reasons for medication, 87 were for prevention of stroke caused by atrial fibrillation, 12 were for the treatment of venous thromboembolism or for prevention of the possible venous thromboem- bolism, and the other 2 were not described. Co-existing diseases or past medical history were described in 88 patients, including hypertension, renal insufficiency, and type 2 diabetes mellitus, etc. Combined medication was described in 67 patients, of which drugs that might increase the risk of bleeding (non-steroidal anti-inflammatory drugs, clopidogrel, P-glycoprotein inhibitors, etc.) were used in 35 patients. Other combined drugs were antihypertensive drugs and hypoglycemic drugs, etc. Serious AE occurred from 2 minutes to 5 years after medication and 33 cases occurred within 1 month after the start of medication. Serious AE associated with dabigatran etexilate were bleeding in 81 patients (including gastrointestinal bleeding, intracerebral hemorrhage, coagulation disorder, etc.), kidney injury/renal failure in 8 patients, esophageal ulcer in 4 patients, liver injury in 2 patients, and thrombocytopenia, leukocyte fragmentation vasculitis, and severe cough with dyspnea in 1 patient respectively. The main measure taken after AE occurence was drug withdrawal. Those who were not improved after drug withdrawal were given symptomatic treatment, and hemodialysis were performed on those who fail to respond to the treatment. A total of 29 patients died and all of them had bleeding events. Among the 101 patients, 43-had medication errors, of which 33-had overdose, 6 had contraindications, and 4 had wrong administration methods. Conclusions Serious AE related to dabigatran etexilate manifest mostly as bleeding in clinic and can occur from 2-minutes to 5 years after medication, which can lead to death in severe cases. Medication error is one of the important causes of serious AE related to dabigatran etexilate, so the label should be strictly followed when prescribing the drug and medi- cation guidance should be given to patients.
  • Deng Meiyu, Yu Xuhong, Zhang Linghui, Chen Ling
    Adverse Drug Reactions Journal. 2022, 24(12): 641-646. https://doi.org/10.3760/cma.j.cn114015-20220418-00330
    Objective To understand the occurrence and the clinical characteristics of meropenem- related central nervous system (CNS) adverse reactions. Methods Using the hospital information system, the electronic medical records of patients who were hospitalized in the Department of Respiratory, the 305 Hospital of the People′s Liberation Army from January 2016 to December 2021 and received meropenem were collected. Medical records of patients who developed CNS symptoms after meropenem administration were screened and analyzed retrospectively. The data extracted from the medical records mainly included gender, age, infectious diseases, underlying diseases, renal function at admission [serum creatinine, endogenous creatinine clearance (Ccr)] in the patient, the application of meropenem (dose, whether dose was adjusted according to Ccr), and the occurrence (occurrence time, main clinical manifestations, etc.), treatment, and outcome of meropenem-related CNS adverse reaction. The incidence of meropenem-related CNS adverse reactions was calculated, and their clinical characteristics was descriptively analyzed. Results A total of 636 patients used meropenem during the set period and 17 of them developed meropenem-related CNS adverse reactions, with an incidence of 2.7%. Among 17 patients, 10 were male and 7 were female, aged from 74 to 94 years with a median age of 86 years. Thirteen patients had pulmonary infection (one with urinary system infection) and 4 had acute exacerbation of chronic obstructive pulmonary disease (2 with type Ⅱ respiratory failure); 14 patients had combined renal insufficiency (10 of them had a Ccr <50-ml/min) and 5 had sequelae of cerebral infarction. Ten patients were with Ccr <50-ml/min and 3 of them did not adjust the dose of meropenem according to Ccr, resulting in excessive dosage. The time to onset of CNS symptoms in 17 patients ranged from 1 to 7 days after starting meropenem, with a median time of 3 days. Twelve patients presented mainly with psychiatric disorders (including delirium, agitation, hyperarousal, hallucinations, confusion and sleep reversal, etc.), and 5 with limb or orolingual convulsions. Meropenem was discontinued in all 17 patients after the onset of CNS symptoms and 5 of them were given symptomatic treatments. Symptoms were relieved after 1-7 days in all the patients, with a median time of 3 days. Conclusions Meropenem- related CNS adverse reactions are more common in elderly patients and patients with renal insufficiency, respiratory failure, and a history of CNS diseases. The main manifestations are mental disorders and convulsions, which mostly occur within one week of drug use. Stopping meropenem in time and receiving appropriate symptomatic treatments contribute a good prognosis in patients.
  • 调查研究
    Jia Yijie;Wang Yuqin;Chang Hongjun;Lin Xiaolan
    . 2003, 5(4): 231-234.
    Objective:To investigate adverse effects associated with traditional Chinese medicines for clinical reference.Method:ADR reports of our hospital during1998-2001were analysed.Results:ADRs occured in several organs systems,mainly in skin and its appendages and cardiovascular system.Among more severe reactions were anaphylactic shock,laryngeal edema and dyspnea,probably caused by allergy.Conclusion:Traditional Chinese medicines should be used with more care owing to yearly increase of unwanted reactions.
  • Wu Xiaoyan, Yu Hao, Zhou Yang, Cai Haodong, Jiang Yuyong
    Adverse Drug Reactions Journal. 2021, 23(11): 584-581. https://doi.org/10.3760/cma.j.cn114015-20211013-01064
    Objective To explore the effects of tenofovir alafenamide fumarate (TAF) and tenofovir disoproxil fumarate (TDF) on blood lipid. Methods The relevant databases (up to August 31, 2021) were searched. The data of dyslipidemia in treatment of hepatitis B virus (HBV) or human immunodeficiency virus (HIV) infection with TAF (trial group) and TDF (control group) in randomized controlled trials (RCTs) were collected. Methodological quality was evaluated by bias risk assessment tool of Cochrane collaborative network, and the meta-analysis was conducted using RevMan 5.3-software. The effect value was the risk ratio (RR) and its 95% confidence interval (CI). Results A total of 11 RCTs were enrolled in the analysis, including 4 on the treatment of hepatitis B (HBV subgroup) and 7 on the treatment of AIDS (HIV subgroup), and the methodological quality evaluation results showed low risk of bias for all. Eleven thousand eight hundred and eighty-eight patients were involved in the 11 RCTs, of which 6-273 were in the trial group and 5-615 in the control group. The results of meta-analysis showed that the incidences of increased low density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and triglyceride (TG) with the severity of ≥3 grade were higher in the trial group than those in the control group and the differences of incidences in LDL-C and TC increase were significant between the 2 groups [LDL-C: 2.9% (157/5-347) vs. 0.8% (37/4-727), RR=3.39, 95%CI: 2.35-4.89, P=0.001; TC: 0.7% (36/4-880) vs. 0.1% (6/4-397), RR=4.25, 95%CI: 1.91-9.45, P<0.001; TG: 0.5%(16/3-157) vs. 0.3%(8/3-102),RR=1.83,95%CI:0.81-4.15, P=0.140]. The changes of blood lipid after treatment were compared and the results showed that the increase of LDL-C was higher in the trial group (14.00-mg/dl) than that in the control group (4.00-mg/dl), and the difference was statistically significant (P=0.004). Conclusion TAF can significantly increase the levels of LDL-C and TC in patients.
  • Guo Aibin, Yin Rong
    Adverse Drug Reactions Journal. 2021, 23(12): 639-643. https://doi.org/10.3760/cma.j.cn114015-20210705-00746
    Iodinated contrast encephalopathy is a rare complication after angiography or interventional therapy with iodinated contrast medium (ICM), with an incidence of 0.13%-2.92%. Iodinated contrast encephalopathy usually occurs minutes to hours after the use of ICM. Its clinical manifestations are diverse, and transient cortical blindness is the most common. Most patients have a good prognosis and generally recover completely within 48-72-hours, while a few may have irreversible neurological damage. The pathogenesis of iodinated contrast encephalopathy is not clear, which may be related to high-dose exposure of ICM due to the damage of blood-brain barrier and the direct cytotoxicity of ICM. Previous history of chronic kidney disease and stroke are risk factors for iodinated contrast encephalopathy, and types of ICM and body parts of angiography or intervention may have different influence on it. After angiography or interventional treatment using ICM, whether patients have symptoms such as mental disorder, visual field defect, and epilepsy should be observed. Once suspicious symptoms appear, CT or magnetic resonance imaging should be completed in time to avoid delaying treatment.
  • 指南与共识
    . 2014, 16(6): 321-6.
  • 安全用药
    . 2006, 8(4): 276-279.
    盐酸西布曲明是20世纪90年代后期开发的新型减肥药,其相关不良反应临床报道较少。本文综述了国内外对西布曲明安全性评价的有关文献,对该药的常见、少见不良反应,与其他药物的相互作用以及防治措施作一介绍,以供临床参考。
  • Si Jigang, Zhou Jian, Zhao Qun, Sun Min
    Adverse Drug Reactions Journal. 2020, 22(10): 587-588. https://doi.org/10.3760/cma.j.cn114015-20191211-01020
    A 78-year-old female patient with hypertension (196/93-mmHg) received a slow IV infusion of urapidil injection 100-mg diluted into 250-ml of 0.9% sodium chloride injection to reduce blood pressure. The infusion rate was controlled at 40 drops/min. If the blood pressure dropped to the target value, the drug would be stopped temporarily. The blood pressure dropped to 152/70-mmHg when urapidil injection was intravenously infused for 40-min (about 80-ml). Then the drug was stopped temporarily. The nurse on duty did not introduce the patient′s condition and the use of urapidil to the nurse who would take turn on duty. The successive nurse did not check the doctor′s order and mistakenly infused the remained urapidil  170-ml within 60-min (60 drops/min). Five minutes later, the patient developed dizziness, fatigue, and severe vomiting, and the blood pressure dropped to 136/66-mmHg. Rehydration treatment was given imme- diately. About 2 hours later, the patient′s blood pressure increased to 158/76-mmHg and the symptoms were relieved.
  • Hao Zhenghua, Geng Xin, Yin Donghong, Duan Jinju
    . 2017, 19(1): 61-62.
    An 82-year-old female patient with severe osteoporosis received an IV infusion of zoledronic acid 5 mg after the right hip artificial femoral head replacement. About 4 hours after the end of IV infusion, the patient presented chill, fatigue, myalgia and high fever. About 6 hours later the patient occurred nausea and vomiting. About 14 hours later the patient developed dyspnea, convulsions, loss of consciousness, and tachycardia. The results of laboratory tests showed the following results: carbon dioxide-combining power (CO2-CP)14 mmol/L, B-type natriuretic peptide (BNP) 1374.07 ng/L, prothrombin time (PT) 20 s, activated partial thromboplastin time (APTT) 37 s , alanine aminotransferase (ALT) 269 U/L, aspartate aminotransferase (AST) 279 U/L, blood urea nitrogen (BUN) 34.6 nmol/L, serum creatinine (Scr) 273 μmol/L. She was diagnosed as respiratory failure, multiple organ failure due to zoledronic acid. She was transferred to ICU, and was given a tracheal intubation with ventilator assisted breathing, she received   symptomatic treatments including those to keep heart rate and blood pressure stable, to protect the functions of liver and kidney. On day 7 in ICU, the patient recovered consciousness. The laboratory tests showed the following results: ALT 135 U/L, AST 137 U/L, BUN 35.3 nmol/L, Scr 217 μmol/L, CK-MB 2.1 μg/L. On day 53 in ICU, her heart rate was 55-86 beats/min, respiration rate was 21-25 times/min, blood pressure was 102-122/51- 69 mmHg (1 mmHg= 0.133 kPa), pulse oxygen saturation was 0.97-1.00. The results of laboratory tests were: ALT 38 U/L, AST 45 U/L, BUN 7.1 nmol/L, Scr 60 μmol/L, CK-MB 1.19 μg/L, myoglobin 0.03 μg/L and BNP 401 ng /L. On day 85 in ICU, the patient regained spontaneous respiration.
  • Wang Chunhui, Wu Wei, Li Xiaoyu, Lyu Qianzhou, Xu Bei
    Adverse Drug Reactions Journal. 2021, 23(3): 158-160. https://doi.org/10.3760/cma.j.cn114015-20201008-01018
    A 60-year-old male patient with lung cancer received IV infusions of toripalimab 200-mg, bevacizumab 500-mg, and pemetrexed 1 g (the treatment was given on day 1 and 21 days was a cycle) due to the progression of tumor after 26 months of first-line and second-line chemotherapy successively. His thyroid function was normal before treatment. After the second medication of toripalimab (on day 30 after the first medication), the patient developed symptoms such as increased heart rate, fear of heat, hyperhidrosis, and weight loss. The reexamination of thyroid function showed triiodothyronine (T3) 3.4-nmol/L, thyroxine (T4) 305.0-nmol/L, free triiodothyronine (FT3) 13.1-pmol/L, free thyroxine (FT4) 55.7-pmol/L, thyroid stimula- ting hormone (TSH) 0.02 mU/L, thyroglobulin (Tg) 32.7-μg/L, antithyroglobulin antibody (TgAb) 531.0 kU/L, antithyroid peroxidase antibody (TPOAb) 318.0 kU/L, and thyroid stimulating hormone receptor antibody (TRAb) 1.00-U/L. Hyperthyroidism was considered, anti-tumor treatment was suspended, and symptoms were improved after metoprolol treatment. Ninety-seven days after the first toripalimab treatment, the patient developed symptoms such as chills, dizziness, fatigue, eyelid edema, weight gain, etc. The laboratory tests showed  T3-0.3-nmol/L, T4-20-nmol/L, FT3-1.0-pmol/L, FT4-1.8-pmol/L, TSH>100.00 mU/L, and carcinoembryonic antigen 251-μg/L. Hypothyroidism was considered, but the tumor progressed, so the treatment of toripalimab was restarted and thyroxine was supplemented at the same time. The patient′s thyroid function was gradually improved and then remained normal. More than 13 months after the first medication of toripalimab, the laboratory tests showed T3-1.3-nmol/L, T4-137.0-nmol/L, FT3-3.8-pmol/L, FT4-21.1-pmol/L, TSH 6.03 mU/L, Tg 3.9-μg/L, TgAb 432.0 kU/L, and TPOAb 222.0 kU/L.
  • Zhang Qingxia, Wang Yawei, Li Xiaoling, Wang Yuqin, Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, Chinese Pharmacological Society Professional Com
    Adverse Drug Reactions Journal. 2022, 24(5): 225-232. https://doi.org/10.3760/cma.j.cn114015-20220421-00346
    In 2021, a total of 19-585 cases of medication error (ME) from 275-hospitals in 28 provincial administrative regions were collected in the National Monitoring Network for Clinical Safe Medication. The number of hospitals reporting ME increased by 7.84% compared with that in 2020 (255-hospitals), and the number of reported ME cases increased by 23.57% compared with that in 2020 (15-849 cases). In 19-585 cases of ME reports, 278 (1.42%) were classified as grade A, 16-221 (82.82%) as grade B, 2-442 (12.47%) as grade C, 410 (2.09%) as grade D, 95 (0.49%) as grade E, 133 (0.68%) as grade F, 1 (<0.01%) as grade G, 4 (0.02%) as grade H, and 1 (<0.01%) as grade I. Among the 19-307 patients with ME of grade B to I, 10-528 (54.53%) were male and 8-779 (45.47%) were female; they aged from 1 day to 102 years, of which 2-236 (11.58%) were children (<18 years old), 9-794 (50.73%) were young and middle-aged people (≥18 to <60 years old), and 7-277 (37.69%) were elderly people (≥60 years old). A total of 234 patients were involved in serious MEs (grade E-I), including 129 (55.13%) males and 105 (44.87%) females, aged from 3 months to 99 years, of which 45 (19.23%) were children, 88 (37.61%) were young and middle-aged people, 101 (43.16%) were elderly people. Among the 16 patients with severe MEs caused by mistaken use of drugs, 14 were children, which was a double of the number in 2020 (7 in 2020); only 3 cases were reported for mistaken use of drugs in children from 2012 to 2019. The 278 grade A MEs did not involve person who triggered the ME and place where ME occurred. Among the 19-307 grade B-I MEs, 13-932 (72.16%) were triggered by physicians, 3-961 (20.52%) by pharmacists, 541 (2.80%) by nurses, 412 (2.13%) by patients and their family members, and 461 (2.39%) by other persons; the proportion of MEs triggered by physicians and patients and their family members increased year by year for 4 consecutive years (60.89%, 65.46%, and 68.05% in 2018, 2019, and 2020 by physicians, and 1.06%, 2.04%, and 2.08% in 2018, 2019, and 2020 by patients and their family members, respectively); 8-662 MEs (44.87%) occurred in clinics, 5-256 (27.22%) in hospital wards, 3-856 (19.97%) in pharmacies, 977 (5.06%) in pharmacy intravenous admixture services, 289 (1.50%) in the nurse stations, 239 (1.24%) in patients′ houses, 6 (0.03%) in the community health service stations, and 22 (0.11%) in other places; the proportion of ME occurred in clinics and at home increased year by year for 4 consecutive years (37.32%, 37.74%, and 43.24% in 2018, 2019, and 2020 in clinics, and 0.41%, 0.89%, and 1.02% in 2018, 2019, and 2020 at home, respectively). The top 3 contents of ME were wrong dosage, wrong drug class, and wrong administration frequency. The top 3 persons who discovered the ME were pharmacists, patients and their family members, and physicians. The top 3 factors causing ME were lack of related pharmacologic knowledge, tiredness, and insufficient training of medical workers.
  • Gu Ling, Bao Wenyi, Qian Jian
    Adverse Drug Reactions Journal. 2021, 23(2): 108-109. https://doi.org/10.3760/cma.j.cn114015-20200519-00558
    An 87-year-old male patient was scheduled for electronic laryngoscopy examination due to pharyngeal discomfort. Before the examination, he was anesthetized locally with 10-ml dyclonine hydrochloride mucilage in his mouth and vomited out 5-minutes later. After spitting out the medicine, the patient developed shortness of breath, fatigue, and dyspnea suddenly 5-minutes later; cold sweat and syncope appeared 20-minutes later; his pulse oximeter oxygen saturation (SpO2) decreased to 0.50 and unconsciousness appeared 30-minutes later. Severe allergic reaction was diagnosed, which mainly manifested as acute respiratory failure and might be related to dyclonine hydrochloride mucilage. Endotracheal intubation and ventilator assisted ventilation were performed immediately, and anti-infection, expectorant, nutritional support, stable internal environment maintaining treatments were given at the same time. After 6 days′ treatments, the endotracheal intubation was removed and the nasal tube was used for oxygen inhalation. Then the SpO2 was 0.99 and the above-mentioned symptoms disappeared.
  • Ye Yating, Dou Guorui, Chang Tianfang, Chu Zhaojie
    Adverse Drug Reactions Journal. 2021, 23(6): 312-316. https://doi.org/10.3760/cma.j.cn114015-20200901-00922
    The ocular adverse reactions of paclitaxels can involve the ocular surface, ocular appendages and intraocular tissue, with various clinical manifestations, such as dry eye, lacrimal duct obstruction, conjunctivitis, keratitis, macular edema, retinal injury, optic nerve injury, etc., which can lead to irreversible visual impairment. The mechanism of ocular adverse reactions is still unclear. In these adverse reactions, macular edema may be related to the dysfunction of retinal pigment epithelial cells and Müller cells caused by paclitaxel, and others may be related to the cytotoxicity of paclitaxels. Baseline eye examination should be performed prior to the use of paclitaxels, and new ocular symptoms should be closely monitored during the treatment. Ocular adverse reactions can be diagnosed definitively through routine ophthalmic examination. The main treatments are timely adjustment of drugs and symptomatic treatments.
  • Gao Feimeng, Song Zhihui
    Adverse Drug Reactions Journal. 2020, 22(6): 381-382. https://doi.org/10.3760/cma.j.cn114015-20200305-00219
    A 56-year-old male patient received an IV infusion of methylprednisolone 500-mg/d, which was changed to oral prednisone 40-mg/d after 3 days, for thyroid associated ophthalmopathy. Calcium carbonate, calcitriol, alendronate sodium, and esomeprazole magnesium enteric-coated tablets were given orally to prevent hormone-related adverse reactions. The renal function of the patient was normal in the past, but continued to decline after 1 month of medication. And at the end of 3 months after medication, the lowest estimated glomerular filtration rate (eGFR) was 33.1-ml/(min·1.73 m2). Renal diseases and urinary tract obstruction were excluded by routine urine analysis and color Doppler ultrasound examination of the kidneys. Kidney injury caused by esomeprazole magnesium enteric-coated tablets was considered. Then the drug was replaced by famotidine and the other drugs were continued. After 9 days, the renal function of the patient gradually recovered, with the eGFR of 74.0 ml/(min·1.73 m2) at discharge.
  • Wu Jianbiao, Yu Li
    Adverse Drug Reactions Journal. 2020, 22(5): 311-312. https://doi.org/10.3760/cma.j.cn114015-20180917-00931
    An 83-year-old male patient received moxifloxacin hydrochloride (moxifloxacin) 400-mg once daily orally for acute attack of chronic obstructive pulmonary disease. He developed scattered red rashes, accompanied by itching, on his both lower limbs 5 hours after the first dose. Next day, the rashes involved skin on the trunk, and purpura appeared on the multiple skin below the knees. Laboratory tests showed platelet count (PLT) 1×109/L,and thrombocytopenia related to moxifloxacin was considered. Moxi- floxacin was stopped and the treatments including hemostasis, anti-allergy, regulation of immune function, and platelet transfusion were given. On day 2 of drug withdrawal, his PLT was 3×109/L, and on day 4 the PLT was 35×109/L. He was transferred to a superior hospital and received the therapy including anti-immune response, platelet-raising, and hemostasis for 5 days. Then his PLT increased to 244×109/L.
  • Wang Fenfang, Bao Jingya, Wu Qihuan
    Adverse Drug Reactions Journal. 2023, 25(3): 190-192. https://doi.org/10.3760/cma.j.cn114015-20220615-00530
    A 56-year-old male patient with nasopharyngeal carcinoma had progressed disease after receiving radiotherapy, chemotherapy, and targeted therapy, etc. Then he received chemotherapy combined with immunotherapy (capecitabine and sintilimab). Before receiving the 3rd immunotherapy, no abnormality was found in the relevant examination in the patient. On the 3rd day of treatment, he developed cough, shortness of breath, and other symptoms, and chest CT imaging indicated inflammatory lesion of both lungs. The results of sputum culture, sputum smear examination, G test, GM test, and autoantibody examination were all negative. Infectious pneumonia and interstitial pneumonia with autoimmune features were excluded. The common respiratory adverse reaction to capecitabine was pharyngeal discomfort, and no large-scale pneumonia caused by capecitabine was reported. Therefore, it was considered to be immune- associated pneumonitis cause by sintilimab. Treatments such as intravenous injection of methylprednisolone, IV infusion of cefoperazone sodium and sulbactam sodium and moxifloxacin were given and the patient′s condition was improved. After that, methylprednisolone dose was gradually reduced, and then changed to oral prednisone. On the 10th day of oral prednisone, the symptom of shortness of breath worsened. Chest CT imaging indicated that the pneumonitis was more severe than before. Intravenous methylprednisolone was re-given but the condition was not improved.
  • Li Xue, Zhang Qingxia, Yin Chunlin
    Adverse Drug Reactions Journal. 2022, 24(7): 365-370. https://doi.org/10.3760/cma.j.cn114015-20220223-00148
    Metoprolol and propafenone are commonly used drugs in cardiovascular diseases. Both drugs are metabolized by liver cytochrome P450 (CYP) 2D6. However, propafenone is not only a CYP2D6 substrate, but also a CYP2D6 inhibitor, which may interact with metoprolol and cause adverse reactions. This interaction also depends on CYP2D6 genotype. For patients with CYP2D6 phenotypes of poor metabolizer (PM) and intermediate metabolizer (IM), the combination with propafenone can increase plasma concentration of metoprolol due to the inhibition of propafenone on CYP2D6. Therefore, the combination of metoprolol and propafenone should be avoided as far as possible. For the patients who need the combined treatment with the 2 drugs, attention should be paid to the monitoring of blood pressure, heart rate, and electrocardiogram changes during medication. If possible, CYP2D6 genotype should be detected and the drug dose should be adjusted according to the test results.
  • Li Xiaotong, Zhai Suodi, Wang Qiang, Wang Yuqin, Yin Jia, Chen Yuguo, Chen Rongchang, Zhang Hongjun, Yang Kehu, Li Tianzuo, Zheng Ya′an, Ma Qingbian, Liu Fang, Cui Chang, Zheng Hangci
    Adverse Drug Reactions Journal. 2019, 21(2): 85-91. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.002
    The recommendations of Guideline for Emergency Management of Anaphylaxis  answered 15 clinical questions about diagnosis, preparation for treatment, treatment measures, and post-treatment management of anaphylaxis and a total of 26 recommendations were formed. In the recommendations, the quality of evidence was divided into 4 levels: high, moderate, low, and very low. And the strength of recommendation was divided into 2 levels: strong and weak. The strength of recommendations was mainly determined by weighing the advantages and disadvantages, instead of relying on the quality of evidence. Emergency management of anaphylaxis in clinical practice could be carried out with reference to the recommendations of this guideline.
  • Jiang Kun, Song Linjing, You Lina
    Adverse Drug Reactions Journal. 2020, 22(9): 529-530. https://doi.org/10.3760/cma.j.cn114015-20190508-00411
    A 64‑year‑old female patient with endometrial cancer received an IV infusion of dexamethasone sodium phosphate injection 10 mg dissolved in 5% glucose injection 100 ml before chemotherapy to prevent allergic reaction induced by paclitaxel. The infusion was finished within about 30 minutes and the patient had no discomfort during the infusion. About 2 hours later, the patient developed urinary incontinence without urgent and painful urination, which gradually disappeared. Two hours after the second intravenous infusion of dexamethasone sodium phosphate injection, urinary incontinence recurred. After the intravenous infusion of dexamethasone sodium phosphate injection was replaced by oral dexamethasone tablets, the symptoms of urinary incontinence were alleviated. It was considered that the temporary urinary incontinence was probably related to dexamethasone sodium phosphate.
  • Chinese Pharmacological Society Professional Committee of Drug-induced Diseases, Guangdong Pharmaceutical Association
    Adverse Drug Reactions Journal. 2025, 27(3): 129-141. https://doi.org/10.3760/cma.j.cn114015-20240929-00070
    Iron deficiency is the most common cause of anemia. Intravenous iron is a common therapeutic drug for iron deficiency and iron deficiency anemia, which is commonly used in the treatment of anemia patients with chronic kidney disease, heart failure, inflammatory bowel disease, and cancer, as well as anemia patients in perioperative period and during pregnancy and lactation. In order to strengthen the rational use of intravenous iron and improve the pharmaceutical care level, the Chinese Pharmacological Society Professional Committee of Drug-induced Diseases and the Guangdong Pharmaceutical Association organized experts majoring in medicine, pharmacy, nursing, hospital mana- gement and other specialties to develop this consensus through discussing, retrieving domestic and foreign literature, and collecting evidence-based medical evidence. The differences among intravenous iron agents, clinical situations of applica- tion, and the safety issues are considered in the consensus, in order to provide the basis for the rational application and pharmaceutical care in clinic.
  • Wang Xin, Liu Chen, Zhang Yanhong, Ji Bingxin, Cai Haodong
    Adverse Drug Reactions Journal. 2023, 25(11): 683-689. https://doi.org/10.3760/cma.j.cn114015-20230727-00558
    Conducting quality evaluation of adverse drug reaction(ADR) case report and obtaining accurate, objective and scientific data is related to the level and quality of the entire monitoring work, and is an important basis for drug regulatory departments to formulate safety regulatory measures. The research progress and application status of the methodology of quality evaluation of ADR reports abroad were investigated through literature search in this paper. It mainly includes 3 different evaluation methods (WHO quality evaluation method, clinical documentation tool, ADR report quality algorithm) from Uppsala Monitoring Centre, Netherlands and Australia. There are currently 2 versions of ADR report quality evaluation methods in China, which are included in the appendices of the 2005 and 2012 editions of the "Adverse Drug Reaction Reporting and Monitoring Work Manual". Different ADR report quality evaluation methods have different focus points, and it is necessary to develop a scientific evaluation method suitable to provide reference for the quality supervision and management of ADR in China.
  • Zhang Hongmei, Guo Qiushi, Tian Xu, Sun Lirui
    Adverse Drug Reactions Journal. 2022, 24(7): 376-377. https://doi.org/10.3760/cma.j.cn114015-20211123-01181
    A 45-year-old male patient was treated with canagliflozin 100-mg once daily orally for type 2 diabetes mellitus due to poor blood sugar control. On the 4th day of medication, the patient developed slight abdominal distension and fatigue; on the 5th day, the patient felt nausea and general fatigue, and the color of urine became dark brown. The laboratory tests showed serum creatinine (Scr) 136-μmol/L, blood urea nitrogen (BUN) 9.7-mmol/L, urine protein (+), and urinary occult blood (++). Acute kidney injury induced by canagliflozin was considered. Canagliflozin was stopped, and acarbose 50-mg (before meal), 2 Haikun Shenxi capsules (海昆肾喜胶囊), and 3 Jinshuibao capsules (金水宝胶囊) orally thrice daily were given. After 2 days of drug withdrawal, the symptoms of nausea and fatigue disappeared, and the color of urine was normal. After 5 days of drug withdrawal, laboratory tests showed fasting blood glucose 5.6-mmol/L, Scr 112-μmol/L, BUN 8.5-mmol/L, urine protein (-), and urine occult blood (-). After 19 days of drug withdrawal, the patient′s renal function indexes were all within the normal range, and no discomfort symptoms recurred.
  • . 2017, 19(1): 76-77.
  • Yue Xiaolin, Lu Song, Luo Qiao
    Adverse Drug Reactions Journal. 2022, 24(6): 314-321. https://doi.org/10.3760/cma.j.cn114015-20211117-01169
    Objective To evaluate the efficacy, safety, and economy of meropenem in the treatment of infectious diseases by means of rapid health technology assessment. Methods The relevant databases (up to October 6, 2021) were searched to collect the meta-analyses and economic studies on the comparison of efficacy, safety, and economy in the treatment of infectious diseases with meropenem and other antibiotics. The quality of meta-analysis and economic research were evaluated by the Quality Assessment Scale for Systematic Review and Health Economics Evaluation Reporting Standard, respectively. The outcome indicators of meta-analysis were efficacy (clinical cure rate, bacterial clearance rate) and incidence of adverse drug reaction (ADR), the effect indicators were relative risk (RR), odds ratio (OR), or risk difference (RD), and the 95% confidence interval (CI). The economic research indicators were incremental cost- effectiveness ratio and minimum cost. Qualitative description of the results enrolled in this study was conducted. Results A total of 6 meta-analyses and 5 economic studies were enrolled in this study, all of which were of high quality. Efficacy: the clinical cure rate of meropenem in the treatment of febrile neutropenia were higher than those of β-lactam antibiotics alone and β-lactam antibiotics combined with aminoglycoside antibiotics, the differences were statistically significant [55.6% (956/1-720) vs. 49.3% (888/1-798), OR=1.36, 95%CI: 1.18-1.56, P<0.01; 58.3% (429/735) vs. 54.1% (415/767), OR=1.24, 95%CI: 1.01-1.53, P=0.04]. The clinical cure rate of meropenem in the treatment of abdominal infection was higher than those of ceftazidime- avibactam combined with metronidazole, ceftolozane-tazobactam combined with metronidazole, and imipenem, and the differences were all statistically significant [86.6% (581/671) vs. 82.6% (571/691), RD=-0.04, 95%CI: -0.08-0, P=0.03; 87.8% (388/442) vs. 83.1% (374/450), RD=-0.05, 95%CI: -0.10-0, P=0.04; 90.8% (1-791/1-972) vs. 87.6% (1-884/2-151), OR=1.52, 95%CI: 1. 23-1. 86, P<0.05]. The bacterial clearance rate of meropenem in the treatment of abdominal infection was higher than those of ceftazidime-avibactam combined with metronidazole, and imipenem, and the differences were all statistically significant [89.8% (491/547) vs. 85.5% (430/503), RD=-0.04, 95%CI: -0.08-0, P=0.04; 87.0% (1-109/1-274) vs. 82.3% (1-054/1-278), OR=1.45, 95%CI: 1.15-1.80, P<0.05]. The differences of bacterial clearance rate in treatment of abdominal infection among meropenem, ceftolozane-tazobactam combined with metronidazole, and β-lactam antibiotics were not statistically significant (all P>0.05). Safety: the differences of incidence of ADR in treatments of febrile neutropenia and pneumonia among meropenem, β-lactam antibiotics alone, β-lactam anti- biotics combined with aminoglycoside antibiotics, and non-carbapenem antibiotics were not statistically significant (all P>0.05). Economy: ceftazidime-avibactam, ceftolozane-tazobactam, and imipenem had better cost- effectiveness advantages than meropenem in the treatment of abdominal infection, pneumonia, and febrile neutropenia. Conclusions Meropenem has good efficacy in the treatment of febrile neutropenia and abdominal infection. There is no significant difference in safety between meropenem and other anti-biotics, but meropenem has no economic advantage.
  • Pan Bobo, Xu Xiaohong, Lu Xiaoyan, Huang Yuena, Zhong Han, Dai Youqin
    Adverse Drug Reactions Journal. 2021, 23(12): 661-663. https://doi.org/10.3760/cma.j.cn114015-20210208-00182
    A 54-year-old female patient was scheduled to undergo laparoscopic segmental resection for hepatic hemangioma. Thirty minutes before operation, an IV infusion of etimicin sulfate and sodium chloride injection 100-mg was given to prevent infection. After 2-minutes of medication, the patient developed general numbness, apathy, redness of the skin, cold sweating, and dyspnea. Her breath rate was 22 times per minute, heart rate was 110 beats per minute, blood pressure was 45/32-mmHg, and pulse oxygen saturation (SPO2) was undetectable. Anaphylactic shock due to etimicin was considered. Etimicin was discontinued immediately and treatments such as oxygen inhalation, epinephrine, methylprednisolone sodium succinate, norepinephrine, and intravenous volume expansion were administered. Twenty minutes later, the patient′s symptoms were basically relieved, with breath rate 18 times per minute, heart rate 88 times per minute, blood pressure 108/60-mmHg, and SPO2-0.99. Thirteen hours later, all symptoms disappeared.
  • 滥用误用
    . 2007, 9(1): 39-42.
    In recent years, club drugs are often abused by teens and young adults, The common club drugs are gamma- hydroxybutyrate, ktamime, MDMA, and flunitrazepam. This paper describes the acute toxic effects of the four drugs in order to be beneficial to the management of their poisoning in clinical practice.
  • 相互作用
    . 2006, 8(1): 33-38.
    通过检索Medline和中国医院数字图书馆数据库,对体内药物相互作用的发生率、发生机制、临床干预方法等内容进行综述,以期引起医务工作者的充分认识,减少药源性损害,提高临床治疗水平。
  • 综述
    . 2000, 2(3): 143-148.
    氨基糖苷类抗生素具有抗菌谱广,对大多数革兰阴性(G-)杆菌引起的感染疗效确切等特点。但该类药物具有个体差异大、治疗指数窄等缺点,应用不当,可引起严重不良反应。本文参考近期文献从葡萄糖转运及其代谢、第二信使、微量元素和线粒体功能等方面就氨基糖苷类抗生素耳毒性的可能机制及临床处置作一综述。
  • Liu Yang, Zhang Liyun, Zhang Gailian, Xu Ke, Gao Jinfang
    . 2017, 19(1): 63-64.
    A 60-year-old woman with connective tissue disease received  cyclosporine 300 mg once daily . On day 2 of adding cyclosporine, the patient  developed pharyngalgia. On day 3, she developed hematochezia, abdominal distension and abdominal pain. On day 14, she lost her vision of both eyes,  developed attacks of binoculus transient upper left gaze twice, a slight headache, and the elevated blood pressure (150/90 mmHg). Laboratory tests showed that the cyclosporine blood concentration was 372.4 μg/L. The results of cranial MRI showed bilateral frontal, parietal, occipital and temporal lobes symmetrical multiple patchy long T1, long T2 signals, the fluid attenuated inversion recovery sequence showed high signal, which suggested the vascular edema.  The patient was diagnosed as reversible posterior encephalopathy syndrome due to cyclosporine. Cyclosporine was stopped immediately. She received an IV infusion of methylprednisolone 40 mg once daily and other symptomatic supportive treatments including deprivation of body fluids, anti-epileptic, and blood pressure control, etc. On day 5 of treatment, her vision began to recover, but she had blurred vision and visual hallucinations. On day 7 of treatment, the degree of abdominal distension and abdominal pain was relieved, vision was recovered obviously, visual hallucination disappeared. Her blood pressure returned to normal (125/86 mmHg). The result of laboratory tests showed the cyclosporine blood concentration 139.2 μg/L. The result of MRI reexamination showed that the original focus disappeared.
  • Li Shanshan, Huang Xiangxin
    Adverse Drug Reactions Journal. 2022, 24(10): 546-548.
    A 3-day and 16-hour old male newborn was treated with IV infusion of meropenem 0.136 g once per 12-h combined with vancomycin 0.05 g once per 12-hours for severe infection. The platelet (PLT) was 116×109/L before treatment and reduced to 7×109/L after 11-h of treatment. Apheresis platelet by intravenous infusion was added, and PLT was 32×109/L 3 days later.Clinical pharmacists remind doctors to pay attention to adverse reactions of vancomycin when participating in ward rounds, and monitor the blood concentration of vancomycin in time. The physicians considered that the thrombocytopenia might be related to severe infection, and methylprednisolone, human immunoglobulin, cryoprecipitated antihemophilic factors, apheresis platelet products and etc. were added. The PLT increased to a transient level of 121×109/L and then continued to decrease. After 8 days of treatment, the platelet PLT decreased to 30×109/L and the trough concentration of vancomycin was 27.0-mg/L. Thrombocytopenia caused by vancomycin was considered.The pharmacist recommended temporary discontinuation of vancomycin. Vancomycin was stopped, PLT was 174×109/L 5 days later.
  • Liu Qun, Jin Wenwen, Geng Ning, Lin Zhonghua, Xin Yongning
    Adverse Drug Reactions Journal. 2020, 22(8): 484-485. https://doi.org/10.3760/cma.j.cn114015-20200506-00497
    A 63-year-old male patient took tamsulosin hydrochloride sustained release capsules 0.2-mg daily and Qianliexin capsules 2 g thrice daily by himself for urinary urgency and urodynia. Twenty- five days later, he developed itchy skin, deep brown urine, nausea, fatigue, and loss of appetite. Laboratory tests showed alanine aminotransferase (ALT) 265-U/L, aspartate aminotransferase (AST) 163-U/L, total bilirubin (TBil) 155.1-μmol/L, direct bilirubin (DBil) 74.7-μmol/L, indirect bilirubin (IBil) 80.4-μmol/L, alkaline phosphatase (ALP) 261-U/L, and gamma-glutamyltransferase (γ-GT) 184-U/L. Liver biopsy showed the cholestatic liver injury. He was diagnosed as acute drug-induced liver injury, which might be related to the above 2 drugs. The above 2 drugs were stopped and oral ursodeoxycholic acid 250-mg thrice daily was given. On day 42 of drug withdrawal, laboratory tests showed ALT 368-U/L, AST 179-U/L,TBil 504.9-μmol/L, DBil 382.8-μmol/L, IBil 122.1-μmol/L, ALP 201-U/L, and γ-GT 58-U/L. On day 91 of drug withdrawal, laboratory tests showed ALT 78-U/L, AST 62-U/L, TBil 138.1-μmol/L, DBil 118.2-μmol/L, IBil 20.2-μmol/L, ALP 140 U/L, and γ-GT 31-U/L. The patient′s liver function returned to normal 135 days after drug withdrawal.
  • 安全合理用药
    . 2007, 9(1): 28-32.
    太尼透皮贴剂是一种新型强效镇痛透皮缓释给药剂型,使用方法简便,不良反应较低,止痛效果好,广泛用于癌性疼痛(CP)和非癌性疼痛(NCP)的治疗。常见的不良反应有便秘、恶心、呕吐和嗜睡等。但如果使用不当或过量,可造成呼吸抑制甚至死亡。因此,使用芬太尼透皮贴剂时应正确选择适应证,掌握个体用药剂量,避免严重不良反应的发生。
  • Liu Ting, Fan Xiaohong, Zeng Yueping, Qin Yan, Ai Sanxi, Li Xuemei
    Adverse Drug Reactions Journal. 2022, 24(6): 332-334. https://doi.org/10.3760/cma.j.cn114015-20211124-01186
    A 69-year-old man was treated with adalimumab 80-mg subcutaneously for psoriasis for the first time. Two days later, the patient developed diffuse erythema with pruritus. Because the active stage of psoriasis was not excluded, adalimumab 40-mg subcutaneous injection was continued once a week for 4 times. The patient′s skin erythema and pruritus continued to worsen. After intravenous infusion of methylprednisolone sodium succinate 40-mg/d for 1 week, the systemic erythema and pruritus were slightly relieved, but the condition was repeated after stopping the drug. Urine routine and sediment analysis showed urinary occult blood (+++), 190 red blood cells/μl, urinary protein(+), and serum creatinine 80-μmol/L. Renal biopsy and skin histopathology suggested IgA nephropathy and psoriasiform dermatitis, respectively. After consultation with dermatologists, erythroderma caused by deterioration of psoriasis was considered. Excluding other factors, it is considered that IgA nephropathy and erythroderma were probably induced by adalimumab. Methotrexate 10-mg per week was given orally and halometasone ointment was used externally. The skin damage in the patient was gradually improved. Hematuria and proteinuria were self-relieved slowly.At one-year of follow-up, the patient′s renal function and urine routine remained normal, and nephropathy and rash did not recur.
  • Miao Miao, Wang Qian, Wang Xia, Zhang Yuan, Guan Fang, Wang Yuqi,
    Adverse Drug Reactions Journal. 2022, 24(8): 417-423.
    Objective To explore the risk factors and the predicting value of early urinary tract infection in patients treated with tacrolimus (TAC)-containing immunosuppressive regimen after kidney transplantation. Methods The medical records of patients who underwent allogeneic kidney transplantation in the Provincial Hospital Affiliated to Shandong First Medical University from January 1, 2015 to October 30, 2021 and received triple immunosuppressive regimen with TAC+mycophenolate mofetil+methylprednisolone were collected and analyzed retrospectively. Relevant clinical data of patients were extracted from the hospital information system. Patients were divided into infection group and non-infection group according to whether urinary tract infection occurred within 1 month after taking TAC and the clinical characteristics in patients between the 2 groups were compared. The risk factors of urinary tract infection were analyzed by binary logistic regression method, and the odds ratio (OR) and its 95% confidence interval (CI) were calculated. The receiver operating characteristic (ROC) curve was used to analyze the predicting value of risk factors on the risk of urinary tract infection. Results A total of 256 patients were entered in the analysis, including 208 males and 48 females, aged 34 (29, 42) years with an range from 18 to 66 years, and the body mass index of these patients was 22.9 (20.4, 25.4) kg/m2, ranging from 13.9 to 34.4-kg/m2. There were 163 living donors from relatives and 93 cardiac dead organ donors (DCD). Among the 256 patients, 56-had urinary tract infection (asymptomatic bacteriuria in 32 patients and symptomatic urinary tract infection in 24 patients) after kidney transplantation with an incidence of 21.9%. The differences in gender, age, body weight, body mass index, primary disease, comorbidity disease, donor source, length of hospital stay after surgery, time of indwelling urinary tube and ureteral stent, postoperative complications, complicated infection in other parts of the body after surgery, laboratory test results and so on in patients between the 2 groups were not significant (all P>0.05). The trough plasma concentrations of TAC on the 7th, 14th, and 21st days after taking TAC in the infection group was higher than those in the non-infection group [9.7 (8.4, 13.5) μg/L vs. 8.0 (6.3, 9.8) μg/L, P<0.001; 9.4 (7.6, 11.0) μg/L vs. 8.0 (6.3, 9.8) μg/L, P=0.002; 9.2 (7.6, 11.1) μg/L vs. 8.2 (6.3, 9.8) μg/L, P=0.002]. The binary logistic regression analysis showed that the high trough plasma concentrations of TAC on the 7th day after taking TAC (OR=1.815, 95%CI: 1.332-2.474, P<0.001) was an independent risk factor for urinary tract infection in the early stage after kidney transplantation. The ROC curve analysis results showed that the area under the ROC curve of TAC trough plasma concentration on the 7th day was 0.704 (95%CI: 0.626-0.782), with the cutoff value 8.35-μg/L, the sensitivity 76.8%, and the specificity 53.5%. The patients were divided into >8.35-μg/L group and ≤8.35-μg/L group according to this cutoff value, the incidences of urinary tract infection in the 2 groups were 31.4% (43/137) and 20.6% (13/119) respectively and the difference was statistically significant (χ2=15.603, P<0.001). Conclusion High trough plasma concentration of TAC on the 7th day after taking TAC is an independent risk factor for urinary tract infection after kidney transplantation and the predicting value is 8.35-μg/L, which has certain predicting value for early urinary tract infection after kidney transplantation.
  • Ni Chunyan
    Adverse Drug Reactions Journal. 2022, 24(3): 144-146. https://doi.org/10.3760/cma.j.cn114015-20210322-00344
    A 72-year-old male patient received anti-infectious treatments with piperacillin sodium and tazobactam sodium, moxifloxacin, and posaconazole, and expectorant treatment with acetylcysteine for pulmonary infection after lung transplantation; original antirejection therapy with tacrolimus and mycophenolate mofetil was continued. Before treatments, serum creatinine was 98-μmol/L and blood urea nitrogen was 3.4-μmol/L. On the 5th day of treatments, the trough blood concentration of tacrolimus increased to 22.9-μg/L, serum creatinine increased to 497-μmol/L, and blood urea nitrogen increased to 17.91-mmol/L. During the consultation, the clinical pharmacists learned that the patient used posaconazole and tacrolimus in combination. They also understood that posaconazole could inhibit the activity of liver cytochrome P450 (CYP) 3A4, while tacrolimus was mainly metabolized by CYP3A4 by searching the literature. Then it is considered that the acute kidney injury caused by tacrolimus occurred due to the increase of blood concentration following the simultaneous application of tacrolimus and posaconazole. Clinical pharmacists recommended that posaconazole was replaced by caspofungin and the dose of tacrolimus was reduced. The clinician adopted the above recommendations and the patient was given continuous venous-venous hemofiltration meantime. Eight days later, the patient′s serum creatinine level gradually decreased to 334-μmol/L, blood urea nitrogen was 7.6-mmol/L, and urine volume was 200-ml. Then hemodialysis was performed 3 times a week; 1 month later, the patient′s serum creatinine was 115-μmol/L, and blood urea nitrogen was 7.2-mmol/L.
  • 安全用药
    . 2006, 8(4): 279-283.
    为了解非典型抗精神病药物引起锥体外系症状(EPS)的情况,利用Medline检索系统对已公开发表的临床随机对照试验与流行病学资料进行分析。非典型抗精神病药物间引起EPS的程度各有差异,有的与剂量相关,总体较经典的抗精神病药物发生率低,严重程度轻。但临床仍应重视锥体外系症状的预防与治疗问题。
  • Wang Le, Yuan Haiyan, Ye Xi
    Adverse Drug Reactions Journal. 2022, 24(7): 373-375. https://doi.org/10.3760/cma.j.cn114015-20211203-01220
    A 52-year-old male patient with primary bronchogenic carcinoma received an IV infusion of sintilimab 200-mg on the first day, oral anlotinib capsules 12-mg once daily on day 1-14, and 3 weeks were a cycle. At the 3rd cycle of treatments, the laboratory tests showed thyroid stimulating hormone (TSH) 0.08 mU/L, and no intervention was given. At the 5th cycle, his free thyroxine (FT4) was 11.45-pmol/L and TSH was 8.19 mU/L, indicating hypothyroidism. The patient received levothyroxine sodium tablets 50-μg orally once daily. Fifty-six days later, his thyroid function returned to normal. On the 3rd day of the 8th cycle of treatments, the patient developed dry mouth, polydipsia, polyuria, nausea, and vomiting, and laboratory tests showed blood pH 7.02, β-hydroxybutyric acid 6.740-mmol/L, and random blood glucose 66.0-mmol/L, indicating diabetes ketoacidosis. Sintilimab and anlotinib were stopped and fluid replacement and insulin hypoglycemic therapy were given. Eleven days later, his ketone body turned negative, and the fasting blood glucose was 5.8-mmol/L. About 2 weeks later, the laboratory tests showed that hemoglobin A1c was 7.8%, the serum C-peptide levels on an empty stomach and 2 hours after breakfast both were less than 0.01-nmol/L, and the islet cell antibody, insulin autoantibody, glutamic acid decarboxylase antibody, and protein tyrosine phosphatase autoantibody were negative, which was consistent with the characteristics of fulminant type 1 diabetes (T1DM). On the morning of the 32nd day of sintilimab and anlotinib withdrawal, laboratory tests showed cortisol 50.7-nmol/L and adrenocorticotropic hormone (ACTH) 2.73-pmol/L, indicating hypoadreno- corticism. Treatment with glucocorticoid was given. It was considered that the patient was with  autoimmune polyendocrinopthy syndrome (APS) type II (hypothyroidism,fulminant T1DM,hypoadrenocorticism) caused by sintilimab. After 9 months of glucocorticoid treatment, cortisol was 16.6, 79.4, and 17.2-nmol/L at 8:00,16:00, and 24:00, respectively, and ACTH was 1.12-pmol/L. The patient still needed maintenance treatment with alternative hormone.
  • Shen Jianghua, Jiang Ruiqi, Zhang Qingxia, Xing Xiaoxuan, Yan Suying
    Adverse Drug Reactions Journal. 2022, 24(8): 410-416.
    Objective To understand the current status of perioperative analgesics use and management in China. Methods A questionnaire was self-designed with the content consisting of 4 dimensions (the basic information of the respondents, perioperative analgesics management, medical behaviors in perioperative analgesia, and understanding of analgesics-related knowledge) and 55 questions (8, 10, 22, and 15 questions under 4 dimensions, respectively). The questionnaire was sent through Wechat by the members of Chinese Pharmacological Society Professional Committee of Drug-induced Diseases and Anesthesiology Branch of the Chinese Medical Association. Anesthesiologists, surgeons/nurses and clinical pharmacists volunteered to participate in the survey and submitted in anonymous form directly. The investigation period was from August 1 to 31, 2020. Results A total of 204 effective questionnaires were received from 45-hospitals in 19 provinces and cities, including 43 tertiary hospitals (95.6%) and 2 secondary hospitals (4.4%). Among the 204 respondents, 46 were surgeons (22.5%), 80 were anesthesiologists (39.2%), 32 were clinical pharmacists (15.7%), and 46 were surgical nurses (22.5%). Of the 45-hospitals where the respondents work, 35 (77.8%) had established regular communication mechanisms for perioperative pain management, and 22 (48.9%) arranged clinical pharmacist to assist the work of the physician in the clinical division. Among the 204 respondents, 76.5% (156 respondents) received knowledge training on analgesics once or twice a year; 60.3% (123 respondents) had found irrational use of perioperative analgesics in their daily work, and the top 3 problems were about drug selection [74.0% (91/123)], usage and dosage [69.1% (85/123)], and drug interactions [46.3% (57/123)]; 37.3% (76 respondents) had found the problem of irrational use of the analgesia pump, and the top 3 problems were about the usage and dosage [69.7% (53/76)], drug selection [67.1% (51/76)], and contraindications [36.8% (28/76)]. Only 13.7% (28/204) of the respondents had a score of ≥120 points (full score of 150 points) in the survey for understanding of knowledge about analgesics. There was 53.9% (110/204) of the respondents with a score of <90 points, including 50.0% (23/46) of the surgeons, 43.8% (35/80) of the anesthesiologists, 46.9% (15/32) of the clinical pharmacists, and 80.4% (37/46) of the surgical nurses. Only 4 of the 15 questions had a correct answer fill rate of >50%. Conclusion Most of the hospitals surveyed have established relevant mechanisms for perioperative pain management, but there are still problems of irrational use of perioperative analgesics and analgesia pumps. About half of the surgeons, anesthesiologists, clinical pharmacists, and most of the surgical nurses have little understanding of knowledge about analgesics.
  • Wang Li, Zhang Liping, Ren Yujiao, Wang Xianjun, Li Zhengrong
    Adverse Drug Reactions Journal. 2022, 24(9): 471-477. https://doi.org/10.3760/cma.j.cn114015-20220427-00368
    Objective To investigate the occurrence and clinical characteristics of extremely severe tirofiban-induced thrombocytopenia (TIT). Methods Patients who used tirofiban during hospitali- zation in Linyi people′s Hospital from March 2015 to September 2021 was screened through the hospital information system. The medical records of patients with extremely severe TIT after medication were collected and analyzed retrospectively. The patient data extracted from the medical records included gender, age, medication indication, comorbidities, tirofiban application, combined drugs, platelet count (PLT) before and after tirofiban use, thrombocytopenia onset time from the application of tirofiban, the time to minimum value of PLT from medication, and the clinical manifestations, intervention, and prognosis of TIT, etc. Results A total of 10-354 inpatients who used tirofiban during the set period were entered, of which 20 (0.19%) had extremely severe TIT. Among the 20 patients, 16 were male and 4 were female, aged 39-84 years with an average age of 66 years, 12 of which were ≥65 years. The medication indications of tirofiban were acute myocardial infarction in 8 patients, cerebral infarction in 5 patients, unstable angina pectoris in 4 patients, and post-operation of coronary artery bypass grafting, transient ischemic attacks, and post-operation of coronary- stent implantation in 1 patient respectively. The comorbidities included hypertension in 13 patients, diabetes mellitus in 4 patients, cerebral infarction in 3 patients, and New York Heart Association (NYHA) greater than or equal to class Ⅲ heart failure in 3 patients. Tirofiban was administered by continuous intravenous pumping for 1-48-hours. The combined drugs included aspirin enteric-coated tablets, clopidogrel tablets, ticagrelor tablets, heparin, low molecular weight heparin, alteplase, and plasmin. Five patients had symptoms of chills and shivers within 1-6 hours after treatment, 7 had oral mucosal bleeding, epistaxis, gingival bleeding, skin ecchymosis, ecchymosis on venipuncture sites, tarry stool, or bloody stool within 1-7 days after treatment, and 10-had no clinical symptoms. The median time from tirofiban application to the onset of PLT decrease and to the minimum value of PLT [(1-18)×109/L] were 12 (6, 20) and 18 (12, 22) hours, respectively, and the 2 kinds of time above were consistent in 13 patients. Tirofiban was discontinued in all patients after the diagnosis of extremely severe TIT, and treatments with glucocorticoids, human immunoglobulin, and platelet infusion were given. PLT recovered to (100-258)×109/L after 3-17 days (median time 4 days) of treatments in 18 patients. The other 2 patients developed tarry stool and bloody stool 2 and 1 days after the diagnosis of TIT, respectively, followed by respiratory and cardiac arrest, and died. Conclusions Extremely severe TIT has low incidence but urgent onset, which can lead to fatal bleeding events, and some patients may have no clinical symptoms. The prognosis is generally good after tirofiban withdrawal and receiving glucocorticoids and symptomatic treatments. However, it should be alert to the adverse consequences caused by secondary bleeding events.
  • Zhang Lina, Fang Wei, Li Jinfeng, Gao Jian, Wang Bing
    Adverse Drug Reactions Journal. 2022, 24(9): 492-494. https://doi.org/10.3760/cma.j.cn114015-20220119-00060
    A 78-year-old female patient was treated with orelabrutinib 100-mg once daily orally due to recurrence of lymphoma. On the 2nd day of treatment, the patient′s fecal occult blood was weakly positive. Three days later, fibrinogen was 0.61-g/L. After intravenous infusion of cryoprecipitated coagulation factor and frozen plasma, the fibrinogen level rose slightly. The patient did not follow the doctor′s advice and took orelabrutinib irregularly, and her fibrinogen level recovered to 1.71-g/L. After further regular treatment with orelabrutinib, her fibrinogen decreased to 0.74-g/L and irregular skin ecchymosis and bleeding spots appeared in the inner side skin of both lower limbs. The fibrinogen in the patient returned to 2.17-g/L after temporary suspension of orelabrutinib and receiving 2 times of intravenous infusion of cold precipitated coagulation factor 10 U, then decreased to 0.94 g/L after reuse of orelabrutinib, and finally recovered to 3.82-g/L after 3 times of intermittent infusion of cold precipitated coagulation factor. It is considered that the hypofibrinogenemia in the patient was caused by orelabrutinib.
  • . 2018, 20(1): 2.
    Based on the potentially inappropriate medication (PIM) criteria in older adults of the United States, Canada, Japan, France, Norway, Germany, South Korea, Austria, Thailand and Chinese Taiwan, and combined with the severe adverse drug reaction (ADR) data in the elderly of China National Center for ADR Monitoring, ADR monitoring center in the Chinese People′ s Liberation Army,Beijing Center for ADR Monitoring and drug data of people over 60 years from Beijing 22 hospitals, 3 rounds of Delphi expert consultation were made to accomplish the final criteria. The criteria was divided into high risk and low risk medications according to the experts evaluation and divided into A and B alert categories according to DDDs. Finally, criteria of potentially inappropriate medications for older adults in China was formed, including medication risk and medication risk under morbid state. A sum of 13 categories 72 medications or medication classes were selected in medication risk part, for example, neurologic medication,psychotropic medication,antipyretic, analgesic and anti-inflammatory medication and cardiovascular medication. The 72 medications were divided into 28 kinds of high risk and 44 kinds of low risk medications. The 72 medications were also divided into 24 kinds of preferred alert medications(A) and 48 kinds of routinely alert medications(B).PIM in the elderly under morbid state contained 44 medications or medication classes under 27 kinds of morbid states, in which 35 medications under 25 morbid states of preferred alert medications (A) and 9 medications under 9 morbid states of routinely alert medications (B).
  • 调查研究
    Gu Ming;Ma Shiping
    . 2006, 8(5): 346-349.
    Objective: To discuss the characteristics and related factors of ciprofloxacin-induced anaphylactic shock, and provide reference for clinical safe drug use. Methods: The literature between January 1979 and December 2005 was retrieved from "Chinese Journal Full-text Database", "Chinese Science and Technology Journal Full-text Database", and "Wanfang Medicine Data China info", Eighty-one cases with ciprofloxacin-induced anaphylactic shock of 73 papers were collected and analyzed. Results: Of the 81 cases, 42(52.5%) were male, 38(47.5%) were female, and one case' sex was unknown; 62(76.5%) were intravenous infusion, and 19(23.5%) were oral administration; 78(96.3%) were recovered, 3(3.7%) were dead. The time to onsef of anaphylactic shock varied from 10 seconds after intravenous infusion of ciprofloxacin to 60 minutes in fifth day after successive treatment of intravenous infusion of ciprofloxacin. Of the cases, 24 had allergic history, 25 had no allergic history. The investigation showed that ciprofloxacin-induced anaphylactic shock was not rare, and it was occurred in almost all areas of the whole country from 1975 to 2005. Conclusion: Careful attention should be paid to the serious reaction of ciprofloxacin-induced anaphylactic shock in clinical practice to ensure safemedication use.
  • Yan Yan, Wang Yawei, Zeng Yan, Yan Suying, Wang Yuqing
    Adverse Drug Reactions Journal. 2022, 24(11): 564-570. https://doi.org/10.3760/cma.j.cn114015-20220817-00753
    Objective To understand and analyze the occurrence of medication error (ME) on insulin preparations and its influencing factors and provide reference for the standard use of insulin preparations. Methods The ME reports on insulin preparation-related MEs in the National Monitoring Network for Clinical Safe Medication (monitoring network) from May 6, 2015 to June 30, 2022, were collected and information of MEs including drugs involved, grading, error content, the persons who caused and found the errors, and the factors that triggered the errors were analyzed. Results During the set period, a total of 2-215 ME reports from 193-hospitals in 26 provinces and municipalities in China were collected in the monitoring network. A total of 2-215 patients were involved, including 1-345 males (60.72%) and 870 females (39.28%), aged from 1 to 95 years, with an average age of (52±4) years. Two thousand one hundred and eighty-two MEs (98.51%) were mild and 33 (1.49%) were severe. The 2-215 ME reports involved 8 classes and 29 kinds of insulin, and a total of 2-263 times of ME content. The top 3 ME contents of insulin preparations were variety errors (40.70%, 921), interaction/compatibility errors (18.29%, 414), and dosage errors (9.06%, 205). Among the 2-215 MEs, 58.24% (1-290 MEs) were triggered by physicians, 28.26% (626 MEs) by pharmacists, 6.5% (144 MEs) by patients and their families, 5.6% (124 MEs) by nurses, and 1.40% (31 MEs) by others; 1-741 MEs (78.60%) were detected and intercepted in time, of which 75.70% (1-318) were found by pharmacists, 14.01% (244) by patients/family members, 7.76% (135) by nurses, and 2.53% (44) by physicians. The main factors that caused MEs were lack of knowledge (23.28%, 701), similar drug names (19.36%, 583), fatigue (14.51%, 437), etc. Conclusions The contents of insulin preparations-related MEs mainly include variety error, interaction/compatibility error, and dosage error. MEs are mainly caused by physicians and mostly discovered and intercepted by pharmacists. Lack of knowledge, similar drug names, and fatigue are the major factors causing MEs.
  • Sun Haiyan
    . 2017, 19(1): 55-57.
    A 77-year-old female patient with pneumonia received an IV infusion of piperacillin sodium and tazobactam sodium 4.5 g dissolved in 0.9% sodium chloride injection 100 ml, 3 times daily. The patient′s WBC, RBC, Hb, and PLT levels were 2.0×109/L, 2.9×1012/L, 88 g/L, and 10×109/L, respectively before using the medicine. On day 4 of drug administration, her WBC, RBC, Hb and PLT were 2.0×109/L, 2.9×1012/L, 88 g/L, and 10×109/L, respectively. The result of  bone marrow smear showed decrease of nucleated cell, granulocyte series,  and  erythrocyte series′ hyperplasia. The proportion and morphology of  cells at different stages were approximately normal. She was diagnosed as acute myelosuppression associated with piperacillin sodium and tazobactam sodium. Piperacillin sodium and tazobactam sodium were stopped. On day 15 of drug withdrawal, her WBC, RBC, Hb and PLT were 4.8×109/L, 3.0×1012/L, 88 g/L, and 218×109/L, respectively.
  • Lu Jiejiu, Huang Guangming, Lyu Chunle, Liu Taotao
    Adverse Drug Reactions Journal. 2021, 23(5): 235-240. https://doi.org/10.3760/cma.j.cn114015-20201009-01019
    Objective To explore the clinical features of tacrolimus-associated posterior rever- sible encephalopathy syndrome (PRES) in patients after kidney transplantation. Methods Relevant databases at home and abroad were searched as of August 2020, and case reports of tacrolimus-associated PRES after kidney transplantation were collected. Clinical information including patient′s basic characteristics, tacrolimus application (such as route of administration, dose, blood concentration, drug combination regimen, etc.), and the occurrence time, clinical manifestation, imaging characteristics, intervention measures, and outcomes of PRES were extracted and analyzed by descriptive statistical method. Results A total of 16 patients were enrolled in the study, including 7 males and 9 females, aged from 7 to 54 years with a median age of 26 years. Of them, 6 patients were <18 years old and 10 patients were ≥18 years old. Among the 16 patients, 8 received intravenous administration and 8 oral administration. Thirteen patients had records of drug combination regimen and 1, 2, and 3 immunosuppressants were combined in 3, 8, and 2 patients, respectively. PRES occurred from 3 days to 3 months after renal transplantation and 10 patients (62.5%) occurred within 1 month after operation. Eleven of 13 patients who underwent tacrolimus plasma concentrations testing did not exceed the upper limit of the treatment window when PRES occurred. The main symptoms of PRES included convulsions/seizures-like seizures (in 11 patients), visual abnormalities (in 7 patients), persistent headache (in 6 patients), and coma or disturbance of consciousness (in 6 patients). CT and/or magnetic resonance imaging were performed in all 16 patients. Imaging features of cerebral edema or vasogenic cerebral edema were found in 15 patients and the lesions located mainly in occipital lobe (13 patients), parietal lobe (12 patients), and the frontal lobe (8 patients). After discontinuation or reduction of the tacrolimus dose and/or giving symptomatic and supportive treatments for 2-44 days (the median time of 9 days), symptoms subsided in all 16 patients and imaging examination showed cerebral edema, vasogenic cerebral edema, and other lesions subsided in 15 patients. Conclusions Tacrolimus-associated PRES mostly occurred within 3 months after renal transplantation, which was not related to the route of administration or blood concentration of tacrolimus. The clinical manifestations of tacrolimus-associated PRES were similar to those caused by other factors. After discontinuation of tacrolimus, reduction of drug dose and/or administration of symptomatic treatment, most of the symptoms disappeared quickly and the imaging changes returned to normal.
  • Chen Huiying, Xu Daliang, Zhu Ying
    Adverse Drug Reactions Journal. 2022, 24(7): 378-380. https://doi.org/10.3760/cma.j.cn114015-20211011-01052
    A 17-year-old male patient received rituximab due to nephrotic syndrome. No obvious discomfort occurred during the first treatment (500-mg by intravenous infusion). After half a year, when the second treatment (300-mg by intravenous infusion) was given, the patient developed symptoms such as fatigue of limbs and inability to lift both lower limbs. Laboratory test showed blood potassium 2.37-mmol/L. Before treatment, the serum potassium was 4.16-mmol/l, and other laboratory test indicators were basically normal. Acute hypokalemia caused by rituximab was considered. Oral potassium chloride was given. On the 2nd day, the symptoms in the patient were relieved, the feeling of powerlessness disappeared, and the blood potassium was 3.06-mmol/L. On the 3rd day, the blood potassium was 4.34-mmol/L. the potassium supplement was stopped after 3 days of medication. The next day, the blood potassium was 4.70-mmol/l, and the patient′s limb weakness and discomfort symptoms disappeared. After that, the patient did not use rituximab again, and no hypokalemia recurred.
  • Liu Wei, Wu Ziyang, Du Guanhua, Li Baohua, Miao Liyan, Song Haiqing, Wang Yuqin, Yang Kehu, Zhang Xianglin, Zhang Yanhua, Zhang Yu, Zhu Zhu, Zhu Jun, Zhai Suodi
    Adverse Drug Reactions Journal. 2023, 25(3): 133-137. https://doi.org/10.3760/cma.j.cn114015-20230302-00142
    Exposure to antineoplastics is a potential health threat. If improperly disposed, it will also cause environmental pollution, which is a medical safety issue worthy of attention. In order to improve the protection awareness of healthcare professionals exposed to antineoplastic drugs (medical personnels, drug transportation staffs, patients and their caregivers, etc.), standardize exposure protection operations, and reduce the risk and harm of occupational exposure, the Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society, the Hospital Pharmacy Professional Committee of Chinese Pharmaceutical Association, the Oncology Society of Chinese Medical Association, the Nursing Branch of China International Exchange and Promotive Association for Medical and Healthcare, and Chinese Pharmacological Society Professional Committee of Drug-induced Diseases formulated the Management guidelines for preventing exposure to antineoplastics, which was published in the 1st issue of Chinese Journal of Cancer Research in 2023. The guideline was developed referring to the World Health Organization handbook for guideline develo- pment and other international methodologies and focused on the full-process management of antineoplastics in hospitals. Using the Delphi method, clinical questions and 14 recommendations were formulated. This paper interprets 14 recommendations, hoping to help promote the implementation of the guideline.
  • Mao Min, Liao Mingyan, Mao Jian, Wang Li
    Adverse Drug Reactions Journal. 2020, 22(12): 711-712. https://doi.org/10.3760/cma.j.cn114015-20200317-00286
    A 16-year-old female patient with acute T-cell leukemia was going to undergo allogeneic hematopoietic stem cell transplantation. Pretreatment chemotherapy was required before operation. In order to reduce the degree of adverse reactions during the chemotherapy, the patient received treatments with ondansetron, dexamethasone, and fosaprepitant dimeglumine. After intravenous injections of ondansetron 4-mg and dexamethasone 5-mg, fosaprepitant dimeglumine 150-mg dissolved in 0.9% sodium chloride injec- tion 150-ml was intravenously pumped at a speed of 300-ml/h. Five minutes later, the patient developed sweating, foreign body sensation in pharynx, dyspnea, periumbilical pain, and vomiting. Anaphylactic reaction caused by fosaprepitant dimeglumine was considered. The drug was stopped immediately and intravenous injection of dexamethasone 5-mg and oxygen inhalation were given. Twenty minutes later, her symptoms of dyspnea and abdominal pain were relieved. Fifty minutes later, the allergic symptoms disappeared.
  • Zhang Kai, Tian Yingchao, Zeng Bingqing, Tang Zhihui
    Adverse Drug Reactions Journal. 2020, 22(10): 601-602. https://doi.org/10.3760/cma.j.cn114015-20191210-01009
    A 26-year-old male patient with type 2 diabetes mellitus was given liraglutide (0.6-mg/d) on the basis of insulin combined with metformin because of the poor therapeutic effect. Four days later, the dose of liraglutide was doubled and empagliflozin (10-mg orally, once daily) was added. The next day, the patient developed nausea, vomiting, and abdominal pain accompanied by elevated serum amylase and lipase (peak levels were 1-048-U/L and 26-U/L, respectively). Acute pancreatitis was diagnosed, all hypoglycemic drugs were discontinued, and fasting, gastrointestinal decompression, intravenous fluid infusion, continuous infusion of low-dose insulin, and symptomatic treatments with lansoprazole and somatostatin were given. Three days later, the patient′s symptoms were relieved, and serum amylase and lipase levels returned to normal. Ten days later, the hypoglycemic drug was changed to subcutaneous injection of insulin aspart 30 injection (24 U in the morning and 16 U in the evening) before meals and oral metformin 0.5 g thrice daily. His blood glucose was controlled and no symptoms of pancreatitis recurred. Therefore, it was considered that the patients′ pancreatitis might be related to the combined use of liraglutide and empagliflozin.
  • Zhou Changkai, Li Wenjing, Hao Xiaojia, Liu Donghua, Ji Hongyan, Xing Xiaomin, Li Jing
    Adverse Drug Reactions Journal. 2023, 25(3): 183-185. https://doi.org/10.3760/cma.j.cn114015-20220417-00327
    A 69-year-old male patient with depression was treated with amfebutamone and mirtazapine for a long time. Because of poor control of symptoms, the treatment plan was adjusted to oral duloxetine (60-mg in the morning) and mirtazapine (15-mg at night). After 13 days of treatments, the patient developed high fever (41.0-℃) with disturbance of consciousness, followed by muscle rigidity and dyspnea. His heart rate was 180 beats/min and blood oxygen saturation was 0.84. Laboratory tests showed serum creatinine (Scr) 609-μmol/L, creatine kinase (CK) 7-102-U/L, myoglobin (MYO)>3-000-μg/L, aspartate aminotransferase (AST) 88-U/L, and total bilirubin (TBil) 33.7-μmol/L. ECG monitoring showed rapid atrial fibrillation. The patient was diagnosed with malignant syndrome caused by duloxetine after excluding infection and other conditions. Duloxetine and mirtazapine were stopped immediately, and symptomatic and supportive treatments including endotracheal intubation, hemofiltration, improvement of water-electrolyte balance, and hepatoprotection were given. On the 6th day of drug withdrawal, the patient′s temperature was 38.2-℃, the blood oxygen saturation was 0.96, muscle tone was improved, and muscle tremor disappeared. On the 16th day of drug withdrawal, the patient′s condition was obviously improved, the consciousness was clear, the temperature was normal, the call could be answered, and no limb convulsion and muscle tremor occurred. Laboratory tests showed Scr 116-μmol/L, CK 250-U/L, MYO 148-μg/L, AST 38-U/L, and TBil 21.4-μmol/L.
  • Li Li, Li Gen, Chen Li, Wu Liping, Guo Wenmei, Tao Wanjun
    Adverse Drug Reactions Journal. 2020, 22(9): 511-517. https://doi.org/10.3760/cma.j.cn114015-20190910-00752
    To explore the risk signals of letrozole related adverse reactions and provide reference for the clinical safety of letrozole. Methods The risk signals related to letrozole in the adverse events (AEs) reports from the first quarter of 2009 to the first quarter of 2019 in the US FDA adverse event reporting system (FAERS) were mined using the reporting odds ratio (ROR) method and the proportional reporting odds ratio (PRR) method. An AE with reports>3 and 95% confidence interval (CI) lower limit of ROR and PRR>1 was defined as a positive signal. AEs were counted and classified using the preferred system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities (MedDRA). The PTs of top 50 adverse event reports and signal strength were selected and analyzed. Results From the first quarter of 2009 to the first quarter of 2019, a total of 31 743 AE reports with letrozole as the primary suspicious drug were reported in the FAERS database. Four hundred and eighty‑three AE risk signals with reports>3 and the 95%CI lower limit of ROR and PRR>1 were detected, involving 16 295 AE reports. After the second screening, PTs with the top 50 AE reports and those with the top 50 PTs ROR values were obtained. After screening out repeated PTs, 93 PTs were included in the analysis, involving 10 138 AE reports. The top 5 system organs in AE reports were neoplasms benign, malignant and unspecified (cysts and polyps) [24.48%(2 482/10 138)], musculoskeletal and connective tissue disorders [21.78%(2 208/10 138)], general disorders and administration site conditions [17.04%(1 728/10 138)], blood and lymphatic system disorders [17.04%(1 728/10 138)], and investigations [5.47%(555/10138)]. There were 32 PTs not labelled in the drug instructions, and PTs with the top 5 signal strength were ovarian fibrosis[ROR=379.63, 95%CI lower limit: 120.87; PRR=278.66, 95%CI lower limit: 120.39], ret gene mutation[ROR=379.63, 95%CI lower limit: 120.87; PRR=278.66, 95%CI lower limit: 120.39], antisynthetase syndrome[ROR=208.84, 95%CI lower limit: 190.30); PRR=174.20, 95%CI lower limit: 101.56], hashimoto′s encephalopathy[ROR=164.85, 95%CI lower limit: 69.68; PRR=142.51, 95%CI lower limit: 67.74], and bone marrow oedema syndrome [ROR=122.82, 95%CI lower limit: 65.47; PRR=110.00, 95%CI lower limit: 64.34]. Conclusions Through data mining, 32 adverse reaction risk signals were found, which were not labelled in the drug instructions. Of them, ovarian fibrosis, ret gene mutation, antisynthetase syndrome, Hashimoto′s encephalopathy, and bone marrow oedema syndrome had strong signals, which were worthy of clinical attention.
  • Huang Gengshi, Liu Guangren, Xiao Jieping, Han Yongzhi
    Adverse Drug Reactions Journal. 2021, 23(4): 172-177.
    Objective To investigate the risk factors of acute kidney injury (AKI) in patients with severe drug eruption. Methods Clinical data including basic information (gender, age, body mass index), type of severe drug eruption, allergenic drugs, co-existing diseases, first laboratory findings after admission, renal function during hospitalization, etc. in patients with severe drug eruption admitted to Department of Dermatology, Guangdong Provincial People′s Hospital from January 2014 to December 2020 were collected and analyzed retrospectively. Patients were divided into AKI group and non-AKI group and the clinical data were compared between the 2 groups. The risk factors of AKI in patients with severe drug eruption were analyzed by a binary logistic regression model and the odds ratio (OR) and its 95% confidence interval (CI) were calculated. Results A total of 91 patients were enrolled in the study, including 50 males and 41 females, aged 54 (40, 65) years with a range of 9-85 years. The drugs that induced severe drug eruptions were allopurinol in 48 patients, antiepileptic drugs in 23 patients, antibacterial drugs in 6 patients, and other drugs in 14 patients. There were 21 patients (AKI incidence: 23.1%) in the AKI group and 70 patients in the non-AKI group. The proportion of patients sensitized to antiepileptic drugs, baseline estimated glomerular filtration rate, levels of serum albumin and hemoglobin in the AKI group were lower than those in the non-AKI group [0(0/21) vs. 32.9% (23/70), (70±12) ml/(min·1.73 m2) vs. (103±6) ml/(min·1.73 m2), 26(23, 30) g/L vs. 36(34, 38) g/L, (116±17) g/L vs. (129±15) g/L], the proportions of patients sensitized to allopurinol, with diabetes mellitus, and with chronic kidney diseases, baseline serum urea nitrogen level, serum creatinine level, and proportion of urinary albumin positive patients were all higher than those in the non-AKI group [81.0%(17/21) vs. 44.3%(31/70), 28.6%(6/21) vs. 7.1%(5/70), 28.6%(6/21) vs. 5.7%(4/70), 7.2(4.6, 12.2) mmol/L vs. 5.0(3.8,6.4)mmol/L, 103(63, 134)μmol/L vs. 67(56, 79)μmol/L, 47.6%(10/21) vs. 17.1%(12/70)], and the differences were statistically significant (all P<0.05). Binary logistic regression analysis showed that allopurinol sensitization (OR=6.588, 95%CI: 1.006-43.123, P=0.049) was the independent risk factor for AKI in patients with severe drug eruption and serum albumin (OR=0.595, 95%CI: 0.471-0.752, P<0.001) was a protective factor. Conclusions Allopurinol sensitization was the independent risk factor for AKI in patients with severe drug eruption. Patients with low serum albumin were more likely to develop AKI.
  • Wu Wei, Chu Binbin, Liang Linchun
    Adverse Drug Reactions Journal. 2020, 22(10): 599-600. https://doi.org/10.3760/cma.j.cn114015-20191211-01013
    A 59-year-old male patient received SOX chemotherapy regimen (IV infusion of oxaliplatin injection 200-mg dissolved in 5% glucose injection 250-ml for 2 hours on the first day, oral tegafur, gimeracil and oteracil potassium 60-mg once daily on day 1-14, every 3 weeks was a cycle) for gastric cancer with multiple lymph nodes metastases. One week after the infusion of oxaliplatin during the third cycle, the patient suddenly developed deafness and blurred vision. The patient was diagnosed with sudden sensorineural deafness and acute optic neuritis after otorhinolaryngologist consultation. His sudden sensorineural deafness and acute optic neuritis were considered to be associated with oxaliplatin. Chemotherapy was discontinued and the patient was given neurotrophic and microcirculation-improving medications. One 1 week later, the patient′s vision gradually returned to normal, but the deafness persisted.
  • Guo Wei, Jia Fei, Liu Shanshan, Zhuang Hongyan
    Adverse Drug Reactions Journal. 2023, 25(3): 159-164. https://doi.org/10.3760/cma.j.cn114015-20221031-01011
    Objective To compare the efficacy and safety between the generic sertraline tablets, which was selected in the national centralized volume-based procurement of drugs (trade name: Weitating), and the original sertraline tablets (trade name: Levofloxacin) in the treatment for depressive disorder, and to provide a basis for promoting the rational use of the generic drugs. Methods Real world study using retrospective mirror-image comparison was adopted. The outpatient data of patients who were prescribed sertraline tablets one year after the implementation of the national centralized volume-based  procurement policy in Beijing Anding Hospital, Capital Medical University were collected. The patients were divided into the generic drug group and the original drug group. After the propensity score matching, the daily dose of prescription, blood concentration of sertraline, and incidence of abnormal laboratory test items (prolactin, liver and kidney function, blood lipids, etc.) of patients in the 2 groups were analyzed. Results A total of 13-659 patients with depression, generalized anxiety disorder, and obsessive-compulsive disorder were enrolled in the study, including 5-973 (43.73%) patients in the generic drug group and 7-686 (56.27%) patients in the original drug group. Among the 5-973 patients in the generic drug group, 2-167 (36.28%) were male and 3-806 (63.72%) were female, aged (34±18) years, ranging from 6 to 94 years. Among the 7-686 (56.27%) patients in the original drug group, 2-709 (35.24%) were male and 4-977 (64.75%) were female, aged (35±19) years, ranging from 6 to 95 years. The difference between the daily dose of sertraline in prescription in the generic drug group and the original drug group was statistically significant [(161.00±46.58) mg vs. (166.34±43.67) mg, t=6.614, P<0.001]. The difference of blood concentration of sertraline in patients between the generic drug group and the original drug group was statistically significant [(50.41±39.49) μg/L vs. (53.80±39.62) μg/L, t=2.616, P=0.009]. The differences in incidence of prolactin elevation and liver and kidney dysfunction between the 2 groups were not statistically significant (all P>0.05). The difference in the proportion of patients with high-density lipoprotein cholesterol lower than limit of the reference value between the generic drug group and the original drug group was statistically significant [41.75% (734/1-758) vs. 38.28% (673/1-758), χ2=4.409, P=0.039]. The difference in the proportion of patients with low-density lipoprotein cholesterol higher than the upper limit of the reference value between the 2 groups was statistically significant [41.75% (734/1-758) vs. 45.39% (798/1-758), χ2=4.738, P=0.032]. Conclusion In this study, no clinically significant differences in efficacy and safety of the generic and original sertraline tablets were found.
  • 专题讲座
    . 2005, 7(3): 203-208.
  • 调查研究
    Chen Yifan;Cai Haodong
    . 1999, 1(1): 28-32.
    Objective: To study the pathogenesis , prevention and management of the liver damage caused by tra-dional Chinese medicines on analysis of cases with liver damage. Methods: This article summarized 427 cases of liver damage caused by traditional Chinese medicines in the last fifteen years and surveyed incidence of liver damage caused by traditional Chinese medicines, distribution of primary diseases, and clinical characteristics. Results: Liver damage cases induced by traditional Chinese medicines were on the increase year by year , amounted to 32.6% in all cases of the drug-induced liver damage. Those traditional Chinese medicines used to treat osteoarthropathy, kidney diseases and skin diseases induced liver damage more often. Zhuanggu Guanjie Wan , Tripterygium wilfordii Hook. f., and Dioscorea bulbifera L. were the most major medicines inducing liver damage. The clinical characteristics and the pathogenesis of liver damage caused by different medicine were varient. Conclusion: Ratio...更多nal use of traditional Chinese medicines and study of their hepatotoxicity should be strengthened further in clinical practice .
  • Niu Xiaoqiang, Wang Yiran, Wang Huimin, Zhou Wenya, Hu Xiaoling
    Adverse Drug Reactions Journal. 2022, 24(3): 116-122. https://doi.org/10.3760/cma.j.cn114015-20211028-01108
    Objective To explore the occurrence and clinical characteristics of thyroid dysfunction caused by camrelizumab. Methods The subjects were selected from all malignant tumor patients who were treated with camrelizumab during hospitalization in Heping Hospital Affiliated to Changzhi Medical College from June 2020 to September 2021. The electronic medical records of patients who met the inclusion criteria were collected, and the general conditions, camrelizumab application, combined medication, and the thyroid function test results before and after the application of camrelizumab were collected. The causality between drugs and injuries in patients who developed thyroid dysfunction was assessed using Naranjo′s causality assessment scale. The clinical characteristics of thyroid dysfunction were analyzed based on the medical records that had evaluation results of "certainly" or "probably". Results A total of 71 patients were included in the analysis, and 22 patients (31.0%) developed camrelizumab-related thyroid dysfunction (causality assessment results were all "probably"). When thyroid dysfunction was found for the first time, hypothyroidism and hyperthyroidism were diagnosed in 11 patients, respectively, and 3 patients with hyperthyroidism developed into hypothyroidism later. The incidences of hypothyroidism and hyperthyroidism were 19.7% and 11.3% respectively. Among the 22 patients, 15 were male and 7 were female, aged 47-78 years; 10 patients were with lung cancer, 4 with gastric cancer, 3 with esophageal cancer, 2 with liver cancer, 2 with breast cancer, and 1 with peritoneal omental mesothelioma; 3 patients were treated with camrelizumab monotherapy, and 19 were treated with camrelizumab combined with chemotherapy and/or targeted drug therapy. Thyroid dysfunction all occurred in the first to sixth cycles of camrelizumab treatment, of which 15 (68.2%) in the first to third cycles. Of the 11 patients with initial diagnose of hypothyroidism, 6 had no obvious symptoms, 5 had fatigue (1 was complicated with apathy), and 4 were subclinical hypothyroidism; the severity was grade 1 in 4 cases and grade 2 in 7 cases. None of the 11 patients with initial diagnose of hyperthyroidism had significant symptoms, and 5 of them had subclinical hyperthyroid. All of the 11 cases were grade 1 in severity, 3 developed into hypothyroidism after 3, 6, and 7 cycles of camrelizumab treatment, which was grade 2 in severity. None of the 22 patients discontinued camrelizumab. No intervention was given to the patients with grade 1 hypothyroidism and hyperthyroidism, of which 3 patients with hyperthyroidism returned to normal on their own and the remaining showed no obvious changes in their thyroid function. Ten patients with grade 2 hypothyroidism received thyroid hormone replacement therapy; thyroid function was normal in 2 patients, improved in 5 patients, and without obvious changes in 3 patients. Conclusions Thyroid dysfunction is a very common adverse reaction of camrelizumab, which can present as both hypothyroidism and hyperthyroidism, and initial hyperthyroidism can evolve to hypothyroidism. Thyroid dysfunction was mostly grade 1-2 in severity and the drug does not need to be discontinued generally. Patients with grade 2 hypothyroidism should be given thyroid hormone replacement therapy.
  • 安全合理用药
    Zhang Haiying;Guan Jinglin;Li Yuzhen
    . 2008, 10(2): 116-7.

    Enteral nutrition (EN) is defined as the administration of a nutrient solution orally or by means of a feeding tube with the purpose of contributing the supply of all or part of the body's nutrient requirements. EN preparations can be classified into three types: elemental type, non-elemental type, and module type. EN is usually given with feeding tube. Non-invasive tube includes nasogastric tube and nasointestinal tube, and invasive tube includes gastrostomy tube and enterostomy tube. Indications for EN include radical surgery in patients with upper alimentary tract or upper respiratory tract, tracheal intubation, esophageal stenosis, dysphagia, anorexia nervosa, largescale burning or trauma. Although considered safer than parenteral nutrition, enteral feeding is not of without complications. The common complications of EN were as follows: (1) mechanical complications such as obstructions of the feeding tube; (2) gastrointestinal complications are abdominal distension, nausea, vomiting, and diarrhea, and they can be reduced or avoided by using gastrointestinal pump or nasointestinal tube, reducing infusion speed, increasing nutrient solution temperature, and using gastrointestinal prokinetic drugs; (3) metabolic complications are mainly hyperglycaemia, and it can be treated with insulin; (4) infectious complications are mainly inhalation pneumonia caused by inhaling nutrient solution or regurgitation into the lungs presenting with sudden dyspnea, fever, increased heart rate. Attention should be paid to its gastric retention.

  • Hu Xiaoling, Niu Yazhen, Cui Yadeng, Wang Shuai
    Adverse Drug Reactions Journal. 2022, 24(8): 437-438. https://doi.org/10.3760/cma.j.cn114015-20220411-00302
    A 75-year-old male patient with pulmonary infection received an IV infusion of piperacillin sodium and tazobactam sodium 4.5 g twice daily. Fifteen minutes after the first medication, the patient developed patches on the skin of both upper limbs with pruritus, chest tightness and suffocation. Physical examination showed heart rate 110 beats/min, breathing rate 26 breaths/min, blood pressure 196/118-mmHg, and oxygen saturation 0.85. Immediate-type hypersensitivity related to piperacillin sodium and tazobactam sodium was considered. The drug was discontinued and symptomatic treatments including glucocorticoids and antiasthma were given. Two hours later, the skin itching was alleviated, the color of erythema became lighter, and the symptoms of chest tightness and suffocation were relieved. Physical examination showed that the heart rate was 100 beats/min, the blood pressure was 150/90-mmHg, and the blood oxygen saturation was 0.90.
  • 综述
    . 2001, 3(3): 145-150.
    他汀类药物(Statins),即3-羟-3甲-戊二酰-辅酶A(HMG-CoA)还原酶抑制剂(HMG-CoA reduc—tase inhibitors),是一种新型降血脂药物,通过竞争性抑制HMG-CoA还原酶,阻断甲羟戊酸代谢的中间产物及最终产物——胆固醇的合成,降低血浆总胆固醇和LDL胆固醇,并影响机体的免疫及炎症反应、血管内皮功能、血栓形成等病理生理过程。他汀类药物有降脂和非降脂两种效应,对于延缓动脉粥样硬化进展及恶化、减少急性冠脉事件和心血管病死率,发挥着重要的作用。此类药物大多在肠道吸收,肝脏代谢,少数可直接经肾脏排泄。临床试验表明,他汀类药物安全、有效,毒副作用少。随着他汀类药物在心血管病一、二级预防中的广泛应用,有必要系统地了解本类药物的临床药理作用和常见毒副作用,为此本文特作介绍。
  • Lin Dan, Zhao Xiu, Jiang Hao
    Adverse Drug Reactions Journal. 2020, 22(11): 646-647. https://doi.org/10.3760/cma.j.cn114015-20200720-00797
    A 31-year-old male patient received moxifloxacin 400-mg orally once daily for pulmonary infection. After 9 days of treatment, the patient developed hemoptysis, hematochezia, and scattered petechia and ecchymosis on his body, with platelet count (PLT) 1×109/L. Thrombocytopenic purpura was diagnosed. Moxifloxacin were stopped and treatments such as hemostasis, recombinant human interleukin-11, and an IV infusion of concentrated platelets were given. Six days later, the patient′s petechia and ecchymosis disappeared and the PLT was 376×109/L. Bone marrow puncture result showed that it was immune thrombocytopenia.
  • Li Chunmei, Liu Lijuan, Ren Yanzhen, Zhou Xuehai, Dai Yajun
    Adverse Drug Reactions Journal. 2021, 23(12): 666-668. https://doi.org/10.3760/cma.j.cn114015-20210223-00210
    A 49-year-old male patient received transcutaneous transcatheter arterial chemoembolization and an IV infusion of camrelizumab 200-mg (on day 1 and 14 days was a cycle) due to liver cancer with intrahepatic metastasis, liver cirrhosis, splenomegaly, and ascites. On day 12 after the third IV infusion of camrelizumab, the patient developed fever, cough, and chest tightness. On day 34 after the third IV infusion of camrelizumab,chest CT showed ground glass exudation shadow in bilateral lungs. Immune-related pneumonitis and infection caused by camrelizumab was considered. High-dose methylprednisolone was given to inhibit immune reaction and cefoperazone sodium and sulbactam sodium was given to resist infection, supplemented with symptomatic and supportive treatments such as oxygen inhalation and expectorant. Eighteen days later, the patient′s body temperature returned to normal, chest tightness disappeared, but he coughed occasionally. Chest CT showed that the ground glass exudation shadow of bilateral lungs was narrowed on the scope.
  • Ma Jie, Liu Min, Cao Yidan, Wang Nan
    Adverse Drug Reactions Journal. 2022, 24(7): 380-382. https://doi.org/10.3760/cma.j.cn114015-20211210-01248
    A 37-year-old female patient with psoriasis received subcutaneous injection of secukinumab 300-mg once a week. Four weeks later, it was changed to subcutaneous injection of 300-mg once every 4 weeks. Seventy-five days later, the patient developed abdominal pain, diarrhea, and fever. The patient had no previous intestinal disease and family history of inflammatory bowel disease. Ulcerative colitis (initial, whole colon, and severe type) was diagnosed by enteroscopy, which was considered to be related to secukinumab. After 2 days of anti-inflammatory treatment with glucocorticoid, the patient′s body tempera- ture returned to normal and the abdominal pain was alleviated; after 9 days, the patient only had a dull abdo- minal pain at night and no other discomfort occurred.
  • Wang Zhizhou, Cheng Hongqin, Bai Xiangrong, Jin Ying, Jiang Dechun, Zhang Shengpeng
    Adverse Drug Reactions Journal. 2020, 22(6): 379-380. https://doi.org/10.3760/cma.j.cn114015-20181221-01269
    A 45-year-old male patient underwent craniotomy and biopsy for intracranial lesions. In order to prevent epilepsy, sodium valproate 800-mg dissolved in 0.9% sodium chloride injection 8-ml was injected intravenously after operation, and then the sodium valproate solution of this concentration was continuously pumped at a speed of 0.6-ml/h. One hour after administration, the serum lactate level of the patient increased gradually, reaching the highest level of 14.7-mmol/L, accompanied by metabolic acidosis and compensatory respiratory alkalosis, and with the lowest pH of 7.09 and the lowest base excess of -26.3. The patient fell into a coma. The hyperlactatemia and metabolic acidosis were considered to be related to sodium valproate. Sodium valproate was stopped, intravenous infusion of 5% sodium bicarbonate injection and blood purification were given at the same time. After 3 days, the lactate level of the patient returned to normal, metabolic acidosis was basically corrected, and his mind was clear.
  • Zhong Zhilei, Chen Qiuyu, Ma Ruilan, Qi Qiucheng, Li Jiaxuan, Yang Jingsi
    Adverse Drug Reactions Journal. 2021, 23(7): 337-341. https://doi.org/10.3760/cma.j.cn114015-20210224-00213
    Vaccines have made great contributions to the prevention of infectious diseases, but vaccine hesitancy is widespread in the world. The reasons for vaccine hesitancy are complex, but the main reasons are the lack of public awareness of vaccine-preventable diseases and the lack of confidence in vaccine effectiveness and safety. In the context of the continuous spread of the coronavirus disease 2019 (COVID-19) epidemic, boosting public confidence and ensuring the orderly development of the vaccination work of COVID-19 vaccines and conventional vaccines are necessary to curb the resurgence of the COVID-19 epidemic and prevent the outbreak of various infectious diseases in China. Under the current situation, the main measures to deal with vaccine hesitancy are to play the role of health care institutions, improve public health literacy, normalize the public opinion orientation of the media platform, strengthen the supervision of vaccine clinical research and production, and do a good job in surveillance and compensation for adverse events following immunization.
  • Tang Jinyan, Lu Peipei, Yang Hui, Qian Hui, Xi Junzuan, Shen Jinhua
    Adverse Drug Reactions Journal. 2021, 23(6): 324-325. https://doi.org/10.3760/cma.j.cn114015-20201120-01163
    A 53-year-old male patient received intramuscular injection of diclofenac sodium and lidocaine injection 2-ml for abdominal pain. After one hour of medication, the patient developed upper abdominal discomfort, chest tightness, shortness of breath, sweating, and slight cyanosis of lips. Oxygen inhalation was given immediately. Electrocardiogram monitoring showed blood pressure 105/60-mmHg, heart rate 125 beats/min, and blood oxygen saturation 0.75. His peripheral blood glucose could not be detected. Glucose supplement and hormone therapy were given immediately. About 30-minutes later, the patient developed unconsciousness, no pulsation of the main artery, and cardiac and respiratory arrest. Cardiopulmonary resuscitation and other treatment measures were given immediately. However, the patient did not return to spontaneous heartbeat and breathing and was declared dead. It was considered that the patient′s severe hypoglycemia might be related to diclofenac sodium and lidocaine.
  • Rui Min, Zhu Zhonghua
    Adverse Drug Reactions Journal. 2023, 25(1): 53-55. https://doi.org/10.3760/cma.j.cn114015-20220328-00249
    A 73-year-old male patient with metastatic sarcomatoid carcinoma of lymph node received an IV infusion of tirelizumab 200-mg on day 1, and 3 weeks was 1 cycle. After 10 cycles of treatment, the patient developed dizziness, chest tightness, nausea, and vomiting. Laboratory tasts showed random blood glucose 99.1-mmol/L, serum creatinine (Scr) 260 μ mo/L, blood potassium 5.8-mmo/L, blood sodium 129-mmol/L, and blood osmotic pressure 368 mOsm/(kg·H2O). Blood gas analysis showed pH 7.1 and lactic acid 2.8-mmol/L. Ketoacidosis was considered and treatments such as rehydration, hypoglycemic with insulin, and electrolyte supplement were given. After 5 days of treatments, the patient′s symptoms were improved, and laboratory tests showed blood potassium 4.4-mmol/L, blood sodium 134-mmol/L, carbon dioxide binding capacity 17.0-mmol/L, and fasting C-peptide 0.02-nmol/L. Seven days later, laboratory tests showed fasting C-peptide 0 and 2 h post-prandial C-peptide 0. The patient was diagnosed with fulminant type 1 diabetes mellitus, which was considered to be related to tirelizumab. After 19 days of treatments, laboratory tests showed fasting blood glucose 5.8-mmol/L, blood glucose at 2 hours after meal 19-mmol/L, Scr 102-μmol/L, blood sodium 139-mmol/L, blood chlorine 108-mmol/L, and blood potassium 3.9-mmol/L.
  • Zheng Aole, Li Xiaoyu, He Qingfeng, Xiang Xiaoqiang
    Adverse Drug Reactions Journal. 2023, 25(7): 430-436. https://doi.org/10.3760/cma.j.cn114015-20221202-01111
    Drug safety is always the primary concern in both the stage of new drug development and the post-marketing clinical application stage, and it is also the main reason for drug development failure and even post-marketing drug withdrawal. The physiologically-based pharmacokinetic (PBPK) model can not only routinely predict the human plasma pharmacokinetics, but also predict the concentration distribution of drugs in different tissues, which has become an important tool for predicting the adverse reactions of new drugs and has gradually attracted the attention of drug regulatory authorities. In this article, the latest progress and application of the PBPK model for predicting drug-induced nephrotoxicity, cardiotoxicity, and neurotoxicity are briefly reviewed to provide references for early prediction of adverse drug reactions in new drug development and rational clinical use of drugs.
  • Chen Qiang, Qu Shanshan, Meng Xianglei
    . 2016, 18(5): 396.
    A 65-year-old man took 4 Lianhuaqingwen capsules thrice daily by himself for upper respiratory tract infection. The patient developed facial swelling and cervical lymphadenopathy after second treatment. Laboratory examination showed the following results: alanine aminotransferase (ALT) 219 U/L,  aspartate aminotransferase (AST) 106 U/L, gamma-glutamyl transpeptidase (γ-GT) 312 U/L, alkaline phosphatase (ALP) 223 U/L, total protein 65 g/L, albumin 33 g/L, albumin-globulin ratio (A/G) 1.02, total bilirubin (TBill) 14.4 μmol/L, direct bilirubin (DBil) 6.7 μmol/L, C-reactive protein (CRP) 110.4 mg/L. drug anaphylaxis and drug-induced liver injury were diagnosed. The patient was given IV infusions of polyene phosphatidylcholine 697.5 mg, reduced glutathione 2.4 g, magnesium isoglycyrrhizinate 150 mg, sodium thiosulfate 1.28 g and intramuscular injection of dexamethasone 5 mg once daily respectively. On day 6, the laboratory tests showed the following results: ALT 69 U/L, AST 19 U/L, γ-GT 275 U/L, ALP 191 U/L, total protein 56 g/L, albumin 24 g/L, A/G 0.76, TBil 16.6 μmol/L, DBil 8.5 μmol/L, CRP 148.2 mg/L。On day 16, the facial swelling disappeared. On day 21, the laboratory tests showed the following results: ALT 53 U/L, AST 36 U/L, γ-GT 155 U/L, ALP 149 U/L, total protein 76 g/L, albumin 32 g/L, A/G 0.71, TBil 6.1 μmol/L, DBil 3.1 μmol/L, CRP 89.5 mg/L.
  • Cai Yue, Wang Yanchun, Zhou Xiaohui, Zhu Xiaoran, Tian Dongdong, Dong Zhanjun
    Adverse Drug Reactions Journal. 2022, 24(12): 664-666. https://doi.org/10.3760/cma.j.cn114015-20220317-00214
    A 49-year-old male patient with type 2 diabetes mellitus and diabetic nephropathy received long term use of retaglinide thrice daily orally, 1-mg in the morning, 2-mg in the afternoon and 1-mg in the evening. Because of the sudden acute cerebral infarction, clopidogrel was added, on the 4th day of the medication, the fasting blood glucose in the patient decreased to 2.6-mmol/L. It was considered that the interaction of clopidogrel and repaglinide caused the increase of repaglinide plasma concentration, which resulted in severe hypoglycemia in the patient. Clinical pharmacist suggested stopping repaglinide and using insulin. The physician reduced the dosage of repaglinide to twice daily, 1-mg in the morning and 0.5-mg in the afternoon, and after 3 days the patient′s fasting blood glucose fluctuated between 4.0 and 4.5-mmol/L. Since the patient had diabetes nephropathy and renal insufficiency, which might increase the risk of hypoglycemia, repaglinide was stopped, and insulin glutamine 3 U was injected subcutaneously before meals, at the same time blood glucose was closely monitored. Fasting blood glucose fluctuated between 4.9 and 5.4-mmol/L after insulin treatment.
  • Qiu Zhihong, Peng Longxi, Li Xiaoming
    Adverse Drug Reactions Journal. 2021, 23(11): 605-606. https://doi.org/10.3760/cma.j.cn114015-20210120-00085
    An 81-year-old male patient with bipedal blue toe syndrome received IV pumping of dexmedetomidine 0.2-mg dissolved in 0.9% sodium chloride injection 48-ml at the rate of 4-ml/h once daily because of severe pain in his left toe. The patient developed irritability and delirium about 6 hours after the 3rd IV pumping. The next day, the pain was relieved and dexmedetomidine was stopped. After drug withdrawal, the patient occasionally had delirium. Due to difficulty in falling asleep, the same dose of dexmedetomidine was given again on the 3rd day of drug withdrawal. The same dose of dexmedetomidine was given twice the next day and obvious delirium and irritability occurred 2-3 hours after drug administration of each time. Delirium was suspected to be related to dexmedetomidine. Dexmedetomidine was stopped again and replaced by tramadol and midazolam. On the 6th day of drug withdrawal, the patient′s consciousness turned clear, and no delirium recured.
  • 综合报道
    . 2001, 3(3): 184-186.
  • Zhao Na, Zhang Ting, Yang Yun, Liao Haibin, Li Xun, Yu Miao, Liu Ran, Yue Wei
    Adverse Drug Reactions Journal. 2021, 23(5): 241-246. https://doi.org/10.3760/cma.j.cn114015-20210225-10218
    Objective To explore the effect of evolocumab on the risk of early intracranial hemor- rhage in patients with acute anterior circulation ischemic cerebral infarction. Methods The medical records of patients with acute anterior circulation ischemic cerebral infarction who were admitted to Tianjin Huanhu Hospital within 48-hours of onset from January 2019 to September 2020 were collected and analyzed retrospectively. On the day of admission, all patients were given statin lipid-lowering therapy and the patients with fasting low density lipoprotein cholesterol (LDL-c) >3.37-mmol/L received combination therapy with statin and evolocumab. The patients who used statins alone were enrolled in the statins group and those with combined application of evolocumab were enrolled in the combination group. The situation of blood lipid level up to standard (LDL-c <1.70-mmol/L) and the occurrence of intracranial hemorrhage in the second week after admission were compared between the 2 groups. The patients were divided into bleeding group and non-bleeding group according to the occurrence of intracranial hemorrhage. The basic information, combined diseases, etiological classification of cerebral infarction, lipid-lowering program, National Institute of Health Stroke Scale (NIHSS) score on admission, blood pressure, blood lipid level, and blood lipid level in the second week of lipid-lowering treatment between the 2 groups were compared. The factors with P<0.05 were enrolled in the multivariate logistic regression analysis, odds ratio (OR) and its 95% confidence interval (CI) were calculated, and the risk factors of intracranial hemorrhage were analyzed. Results A total of 437 patients were enrolled in the analysis, including 358 (81.9%) in the statins group and 79 (18.1%) in the combination group. The differences in basic information, combined diseases, etiological classification of cerebral infarction, lipid-lowering program, NIHSS score on admission, blood pressure, and other clinical features between the 2 groups were not statistically significant (all P>0.05). The baseline levels of total cholesterol (TC), triglyceride (TG), LDL-c, and high-density lipoprotein cholesterol (HDL-c) in the statins group were lower than those in the combination group (TC: P<0.001, TG: P<0.001, LDL-c: P=0.004, HDL-c: P=0.024). At the 2nd week of lipid-lowering treatment, the levels of LDL-c and TC in the statins group and the combination group were lower than those before treatment, but the differences of LDL-c and TC levels before and after treatment in the statins group were significantly lower than those in the combination group [LDL-c: (0.66±0.91) mmol/L vs. (2.58±0.38) mmol/L, P<0.001; TC: (0.37±0.18) mmol/L vs. (1.94±0.44) mmol/L, P<0.001]. The rate of lipid level up to standard in the combination group was significantly higher than that in the statins group [87.3% (69/79) vs. 9.7% (37/358), P<0.001]. The incidences of intracranial hemorrhage were 12.0% (43/358) in the statins group and 13.9% (11/79) in the combination group within 2 weeks after admission respectively. Multivariate logistic regression analysis showed that complication with atrial fibrillation (OR=3.054, 95%CI: 1.402-6.651, P=0.005), higher NIHSS score on admission (OR=3.431, 95%CI: 1.554-7.573, P=0.001), and etiological classificantion as cardiac embolism (OR=1.544, 95%CI: 1.047- 2.278, P=0.028) were independent risk factors for early intracranial hemorrhage. Conclusions The combination of statins and elouzumab has better lipid-lowering effect in patients with acute anterior circulation cerebral infarction. No correlation is found between evolocumab and early intracranial hemorrhage.
  • 药源性疾病
    Du Liping;Mei Dan
    . 2007, 9(6): 414-419.
    Drug-induced thrombocytopenia is defined as a platelet count lower than normal range(<100×109/L) caused by a drug,resulting in bleeding and some related symptoms.Drug-induced thrombocytopenia includes at least three mechanisms such as marrow suppression,immunological and non-immunological thrombocytopenia.Drugs that have been more commonly reported to cause thrombocytopenia include cancer chemotherapy agents,heparin,quinidine,quinine,gold salts,valproic acid,and antibacterials.The incidence of thrombocytopenia induced by cancer chemotherapy agents is substantially higher than that caused by other types of drugs.Signs and symptoms associated with drug-induced thrombocytopenia are petechiae,ecchymosis,epistaxis,gingival bleeding.More significant bleeding such as gastrointestinal hemorrhage,hematauria,colporrhagia,and intracranial hemorrhage may occur.Treatment options for drug-induced thrombocytopenia include stopping the suspected causative agent;administering corticosteroids,immunog…更多lobulin or platelet transfusions;gold salt or arsenide-induced thrombocytopenia can be treated with IM dimercaprol to eliminate heavy metals.
  • Qian Zhengyue, Zhang Xiuhong
    Adverse Drug Reactions Journal. 2021, 23(12): 658-660.
    A 16-year-old female patient received ethinylestradiol and cyproterone acetate tablets (1 tablet once daily for 21 days) for artificial menstrual cycle treatment due to irregular menstruation. On the 7th day of medication, the patient developed swelling of the distal right lower extremity, accompanied by pain, and slight limitation of movement, which did not attract attention. The drug was stopped 21 days later. On the 2nd day after drug withdrawal, the patient had vaginal withdrawal bleeding and blood expectoration occurred once on the same day. After 16 days of drug withdrawal, the swelling and pain of the right lower limb was aggravated. Ultrasound showed deep vein thrombosis in the right lower limb, and CT angiography of the pulmonary artery showed embolism in the right lower pulmonary artery. Deep vein thrombosis complicated with subacute pulmonary embolism were diagnosed. Enoxaparin sodium for anticoagulation and symptomatic treatments were given, the symptoms were improved 17 days later. Laboratory tests showed that the platelet count was 90×109/L, the anticardiolipin antibody IgG was 209 GPL/ml, and the platelet-related antibody was positive. Antiphospholipid syndrome was diagnosed. It was considered that the thrombosis was related to ethinylestradiol and cyproterone acetate tablets.
  • 调查研究
    Zhang Zidian;Chen Shan
    . 2001, 3(1): 25-27.
    Objective: To investigate the adverse reactions of cephalosporins. Methods: 148 cases with allergic shock were collected and analysed mostly through Chinese literature retrieval of 1986 - 2000 in addition to a few patients of our hospital. Results: The shock appeared immediately after the drug administration in 66 cases with a severe nature and death followed if the first aid delayed. Conclusion: The treatment of shock and the skin test of drug were discussed. More attention should be attached to the shock associated with cephalosporins.
  • Dai Rui, Zhang Qingxia, Hu Yang, Xie Hao, Wang Huanling, Zhao Bin, Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs
    Adverse Drug Reactions Journal. 2023, 25(12): 717-723. https://doi.org/10.3760/cma.j.cn114015‐20230905‐00661
    Objective To understand the problems of data mining in adverse drug reaction (ADR)/adverse event (AE) signal detection study in China. Methods The literature on ADR/AE signal detection study in SinoMed, CNKI, WanFang Data and VIP databases were retrieved (up to May 30, 2022). The relevant content of the data mining in the literature was investiagted and evaluated from the following 4 dimensions and 9 items: (1) background data, including 1 item; (2) data preprocessing, including 4 items such as drug mapping, AE mapping, missing value processing, and data deduplication; (3) data mining algorithm (DMA), including 3 items such as DMA selection, DMA formula interpretation, and signal threshold; (4) interpretation of the results, including 1 item. According to the relevant specifications and technical requirements of data mining, the reporting/reporting error-free rate of the 4 dimensions and 9 items in the literature was taken as the overall quality evaluation index. Reporting/reporting error-free rate ≥60% was considered to be an excellent level of overall quality. Results A total of 165 articles were included. On the background data dimension, the reporting/reporting error-free rate of using all the other drug data of the entire database in the literature was 35.2% (58/165), which did not reach an excellent level. On the data preprocessing dimension, the reporting/reporting error-free rates of drug mapping, AE mapping, missing value processing, and data deduplication in the literature were 22.4% (37/165), 73.9% (122/165), 10.3% (17/165), and 55.2% (91/165), respectively. The reporting/reporting error-free rate on this dimension was 40.5% (267/660), which did not reach the excellent level, only the rate of AE mapping reached the excellent level. On the DMA dimension, the reporting/reporting error-free rates of ≥2 DMA, DMA formula interpretation, and signal threshold in the literature were 63.6% (105/165), 78.2% (129/165), and 87.9% (145/165), respectively. The reporting/reporting error-free rate on this dimension was 76.6% (379/495), which reached an excellent level. The reporting/reporting error-free rate was 87.4% (144/165), reaching an excellent level. The signals were interpreted as "positive" or "negative" signals in 7 articles, and the meaning of signals were interpreted as causality in 14 articles. The overall reporting/reporting error-free rate in the 165 literature, analyzed from 9 items on 4 dimensions, was 57.1% (848/1-485), which did not reach the excellent level. Conclusion The main problems in the domestic literature of ADR/AE signal detection study are the incomplete selection of background data and the lack of data preprocessing, suggesting that the further relevant studies in China should be improved on above 2 dimensions for better quality of ADR/AE signal detection research.
  • Wang Xinyi, Sun Jialin, Quan Xianghua, Jiang Man, Li Jing
    Adverse Drug Reactions Journal. 2024, 26(1): 6-11. https://doi.org/10.3760/cma.j.cn114015-20230828-00638
    Drug conditional approval refers to the accelerated approval and marketing of clinically urgently needed drugs with outstanding therapeutic value through the form of "approval first, verification later" before completing complete clinical trials. Since the 1990s, the United States, Canada, the European Union, Japan, Australia, and the United Kingdom have successively implemented drug conditional approval for marketing. In 2017, the application for conditional approval of drugs was implemented in China. In this paper, the pre-market conditions and requirements, post-market monitoring and supervision of drugs in China are compared with other countries/regions. Based on the comparison results, the possible optimization directions of China′s drug conditional approval system are summarized and explored.
  • 综述
    . 2005, 7(2): 81-90.
    本文根据近年文献报告,对5种质子泵抑制剂的作用特点、药代动力学、不良反应及相互作用进行综合比较,为临床安全合理用药提供依据。
  • 调查研究
    Bai yuguo;Zhang Aiqin;Zhang Mo;Liu Ling;Wang Haiyan;Zheng Qingmin
    . 2006, 8(5): 342-346.
    Objective: To investigate and analyse the situation of digoxin used in our hospital and the factors affecting on serum-digoxin concentration. Methods: Eight hundred and sixty-one data of serum-digoxin concentration were collected in our hospital in 2005. The relationship between serum-digoxin concentration and the factors including age ,sex, serum-creatine concentra-tion was analysed by multivariate regression analysis. Results: The serum-digoxin concentration was affected by the four factors of age, sex, serum- creatine concentration, and the dose (P≤0.05). The relationship between them were con= -0.474+0.750×dose+0.154×Scr+0.128×sex+0.003×age by multivariate regression analysis. Conclusion: Serum-digoxin concentration varies with individuals and is affected by many factors. As regards most patients, the dose of digoxin should not be over 0.125 mg daily. If the serum-creatine concentration exceed the normal range, it is likely to be renal dysfunction to the patient. In such a case, the dose of digoxin should be reduced. As regards women, the dose of digoxin should be carefully adjusted to avoid digoxin toxicity.
  • Zhao Piaopiao, Wang Xin, Fang Feimei
    Adverse Drug Reactions Journal. 2021, 23(3): 150-151. https://doi.org/10.3760/cma.j.cn114015-20200708-00753
    A 64-year-old male patient with comminuted intertrochanteric fracture of right femur received subcutaneous injection of 4-100 U nadroparin calcium once daily for anticoagulant treatment due to pulmonary embolism and thrombosis of both lower limbs before operation. His platelet count (PLT) was 166×109/L before the treatment. After 5 days of treatment, the dose of nadroparin calcium was increased to 4-100 U once per 12-h. On the 8th day after the dose increase, the patient′s PLT increased to 800×109/L. Thrombocytosis was diagnosed, which was considered to be related to nadroparin calcium. The drug was stopped and replaced by rivaroxaban 20-mg once daily orally. Five days later, the patient′s PLT decreased to 590×109/L; 34 days later, PLT was 297×109/L.
  • Ren Wenjing, Zhang Wanlu, Fu Guiying
    Adverse Drug Reactions Journal. 2021, 23(12): 624-632. https://doi.org/10.3760/cma.j.cn114015-20210508-00539
    Objective To explore the adverse reactions to sintilimab in patients with non-small cell lung cancer (NSCLC) and Hodgkin lymphoma (HL). Methods The clinical data of all NSCLC and HL patients who were treated with sintilimab during hospitalization in the Fifth Medical Center of the PLA General Hospital from January 2019 to August 2020 were collected by searching Hospital Information System. The clinical data including patients′ basic information (gender, age, diagnosis), medication (initial treatment or retreatment with sintilimab, single and cumulative dose, combined medication), and occurrence of adverse reactions (involved organs or systems, clinical manifestations, occurrence time, intervention and outcome) were recorded and analyzed retrospectively. The correlation between sintilimab and adverse reactions and the grade of adverse reactions were evaluated according to Hand Book of Adverse Drug Reaction Reporting and Monitoring in China and the International Adverse Reaction Evaluation System of Cancer Chemotherapy Drugs. Results A total of 90 patients were enrolled in the analysis, including 75 NSCLC patients and 15 HL patients, aged from 16 to 81 years with the median age of 63 years; 81 patients were initially treated with sintilimab and 9 were retreated. Eighty-eight patients received sintilimab 200-mg per cycle and 2 patient received 100-mg per cycle. The cumulative dose was 200, >200-1-000, and >1-000-mg in 39, 35, and 16 cases, respectively; 32 patients were treated with sintilimab alone and 58 were treated with sintilimab combined with other regimens. Fifty-three (58.9%) patients had adverse reactions, among which, 41 (45.6%) and 12 cases (13.3%) had grade 1-2 and ≥ grade 3 adverse reactions, respectively. The occurrence time was 1-242 days after treatment. Among the 53 patients, 37 were male and 16 were female, aged 28-80 years; 48 were with NSCLC and 5 with HL. The incidence of adverse reactions in NSCLC patients was significantly higher than that in HL patients [64.0% (48/75) vs. 33.3% (5/15), χ2=4.856, P=0.028]. Forty- eight patients were initially treated and 5 were retreated. Fifty-two patients received sintilimab 200-mg per cycle and 1 patient received 100-mg per cycle. The cumulative dose was 200, >200-1 000, and >1000-mg in 16, 26, and 11 cases, respectively. The difference in the incidences of adverse reactions among patients with different cumulative doses was significant (χ2=9.21, P=0.01). Fourteen patients were treated with sintilimab alone and 39 patients were treated with sintilimab combined with other therapeutic regimens; the incidence of adverse reactions in patients with sintilimab combined with other therapeutic regimens was higher than that in patients with sintilimab monotherapy, and the difference was statistically significant [66.1% (39/58) vs. 43.8% (14/32), χ2=4.701, P=0.03]. A total of 101 times of adverse reactions to sintilimab occurred in 53 patients (1, 2, 3, 4 and 5 kinds of adverse reactions occurred in 24, 16, 9, 2, and 2 patients, respectively), 52 times of them were recorded in the medical records, and 49 times were found by rechecking the results of laboratory and auxiliary tests; 1, 3, and 97 times of adverse reactions were evaluated as “certainly”,“probably”, and “possibly”, respectively. Eighty-nine times (88.1%) of adverse reactions were grade 1-2 and 12 times (11.9%) were equal to or greater than grade 3. Multiple systems or organs were involved in the adverse reactions including blood, hepatobiliary, gastrointestinal, endocrine, respiratory, skin and appendix, heart, skeletal muscle and connective tissue, urinary, and nervous systems, and those with the top 5 incidence rates were blood, hepatobiliary, gastrointestinal, endocrine, and respiratory system adverse reactions[24.4% (22/90), 15.6% (14/90), 14.4% (13/90), 12.2% (11/90), and 11.1% (10/90)]. Twelve patients stopped sintilimab due to adverse reactions, 4 were only closely monitored without special treatment, and 49 received one day to seven months of symptomatic treatments. Among the 53 patients, 8 were cured, 29 were improved, 6 were not improved, 9 were unknown, and 1 died. Conclusions Sintilimab could lead to adverse reactions in multiple systems or organs in patients with NSCLC and HL, such as blood, hepatobiliary, gastrointestinal, endocrine, respiratory, and skin and appendages. The incidence and grade of adverse reactions were lower than those documented in the drug label, and no new adverse reactions were detected.
  • Chen Bing, Wang Lijun, Zhang Peng, Cai Haodong
    Adverse Drug Reactions Journal. 2022, 24(1): 13-23. https://doi.org/10.3760/cma.j.cn114015-20211118-01174
    Objective To analyze and evaluate the enhancement of anticoagulant effect of warfarin by herbal and dietary supplements (HDS) based on case report literature. Methods The case reports on enhancement of anticoagulant effect of warfarin by HDS were selected by searching the relevant databases at home and abroad (up to October 10, 2021). The degree of enhancement of anticoagulant effect of warfarin by HDS was evaluated according to the increase of International Standardized Ratio and the occurrence of bleeding events in patients in the case reports. The reliability scoring standard of HDS-warfarin interaction was established according to the causatity evaluation results between HDS and enhancement of anticoagulant effect of warfarin, the number of case reports, and the other evidences (warnings issued by relevant national institutions, clinical studies, pharmacokinetic/pharmacodynamic studies, experimental animal studies, etc.) and the reliability of enhancement of anticoagulation effects of warfarin by HDS was evaluated. The reliability was evaluated as highly, relatively, possible, and suspicious reliable if the total score was ≥9, 6-8, 3-5, and
    ≤2 points, respectively. Results A total of 41 case reports were enrolled in the analysis, involving 56 patients and 26 kinds of HDS. Five kinds of HDS increased the anticoagulant effect of warfarin slightly, including Chinese angelica (Radix Angelicae Sinensis), melilotus extract tablets, pumpkin seed, fish oil, and milk thistle; 6 kinds of HDS increased the anticoagulant effect of warfarin moderately, including ginger (Rhizoma Zingiberis Recens), mango, bee pollen, scarponon grape, Persian walnut, and grifola frondosa; and 15 kinds of HDS increased the anticoagulant effect of warfarin severely, including cranberry, danshen (Salvia miltiorrhiza), glycyrrhiza (Radix Glycyrrhizae), safflower (Flos Carthami), dandelion (Herba Taraxaci), Lyciumbar barum L., grapefruit, matricaria chamomilla, pomegranate juice, astaxanthin, Artemisia absinthiu, royal jelly, bilberry(Vaccinium vitis-idaea), red dates, and St. John′s wort (Hypericum perforatum L.). The reliability of enhancement of anticoagulant effect of warfarin was evaluated as highly reliable in 1 kind of HDS, namely cranberry (11 points), relatively reliable in 8 kinds of HDS, including danshen, glycyrrhiza, safflower, dandelion, Lycium barbarum L., grapefruit, matricaria chamomilla, and pomegranate juice (8, 7, 7, 7, 6, 6, and 6 points, respectively), possibly reliable in 12 kinds of HDS, including Chinese angelica, ginger, melilotus extract tablets, mango, astaxanthin capsules, bee pollen, Artemisia absinthium, royal jelly, scarponon grape, Persian walnut, bilberry, and grifola frondosa (5, 5, 5, 5, 4, 4, 4, 3, 3, 3, 3, and 3 points, respectively), and suspicious reliable in 5 kinds of HDS, including pumpkin seed, red dates, fish oil, milk thistle, and St. John′s wort (2, 2, 2, 0, and -1 points, respectively). Conclusions The degree and reliability of enhancement of anticoagulant effect of warfarin by cranberry, danshen, glycyrrhiza, safflower, dandelion, Lycium barbarum L, grapefruit, matricaria chamomilla, and pomegranate juice are higher, which should be avoided during warfarin therapy.
  • Gao Lingyan, Zhai Dongdong, Ge Sang, Liu Hua
    Adverse Drug Reactions Journal. 2020, 22(12): 695-696. https://doi.org/10.3760/cma.j.cn114015-20200216-00122
    An 89-year-old female patient received escitalopram 10-mg once daily for depression. Three months later, the patient was admitted to hospital for sudden dizziness and a fall. Escitalopram was continued after the admission. On the 6th day of admission, the patient developed syncope again, transient ventricular tachycardia was found by electrocardiogram (ECG) monitoring, and the ECG showed the rate-corrected QT interval (QTc) 612-ms. Escitalopram was discontinued. However, the next day the patient developed ventricular tachycardia again, and the ECG showed Torsades de Pointes and QTc 727-ms. The serum potassium level was 2.84-mmol/L and the patient was given intravenous and oral potassium supplementation. On the 9th day of admission, the patient′s serum potassium level and ECG returned to normal, and the QTc was 487-ms. Escitalopram (with the same dose as before) was given again. The next 5 days, her QTc gradually extended to 506-ms, but serum potassium was normal. Escitalopram was discontinued again and the QTc shortened to 495-ms 2 days later. After 27 days of drug withdrawal, the ECG showed the QTc was 467-ms.
  • 药物滥用
    . 2005, 7(4): 272-274.
    鉴于20世纪末,我国出现俗称″冰毒(甲基苯丙胺)、摇头丸(亚甲二氧基甲基苯丙胺)和K粉(氯胺酮)″的毒品滥用问题。这些毒品被称为″新型毒品″,是相对鸦片、海洛因等传统毒品的一大类滥用毒品的称谓,同海洛因等传统阿片类毒品相比,此类毒品具有精神依赖性强,而身体依赖性相对弱的特点。现主要在娱乐场所被滥用,″新型毒品″滥用的群体广泛,不仅导致严重身心损害,也影响社会安定团结。本文主要介绍了全球范围滥用的几种″新型毒品″的药理学、毒理学作用特点和滥用导致的危害。
  • Tang Yang, Ma Yanbin, Wang Shuyun, Guo Qian, Yin Donghong, Duan Jinju
    Adverse Drug Reactions Journal. 2023, 25(11): 662-668. https://doi.org/10.3760/cma.j.cn114015-20230417-00277
    Objective To understand the risk signal of ocular adverse events (AE) related to mycophenolate mofetil (MMF) and to provide reference for the safe clinical use of this drug. Methods The US FDA Adverse Event Reporting System database was searched, and the AE reports on MMF as the primary suspect drug from the 1st quarter of 2004 to the 3rd quarter of 2022 were collected. AEs were counted and classified using the preferred system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities version 24.0, and ocular AEs were screened out. The ocular AE risk signals were explored using 3 frequency methods, including reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, and Bayesian confidence propagation neural network method, and the multi-item gamma-Possion shrinker (MGPS) method. The information of the ocular AE reports and AE risk signals of MMF were analyzed descriptively. Results A total of 402 cases of ocular AE with MMF as the primary suspect drug were collected, which involved 402 patients, 31 PTs and 5 SOCs. The 402 AE cases were reported among 33 countries, 283 of which had clinical outcome records, including death in 32 cases (11.3%), disability or blindness in 142 cases (50.2%), life-threatening in 14 cases (4.9%), and hospitalization or prolonged hospitalization in 95 cases (33.6%). Results of the frequency method showed that all 31 PTs were risk signals, while the results of the MGPS method manifested that 22 PTs were risk signals. None of the 31 PTs were recorded in the drug labels. The top 5 PTs in the number of AE reports were blindness (136 cases), cytomegalovirus chorioretinitis (37 cases), uveitis (34 cases), endophthalmitis (29 cases), and necrotising retinitis (22 cases). The ranking of signal intensity showed by the 4 methods was similar. The top 5 PTs with the high signal intensity were orbital apex syndrome [ROR=55.84, PRR=55.83, information component (IC)=5.58, empirical Bayesian geometric mean (EBGM)=47.71], quadrantanopia (ROR=43.22, PRR=43.21, IC=5.26, EBGM=38.21), retinitis viral (ROR=40.13, PRR=40.13, IC=5.16, EBGM=35.78), optic discs blurred (ROR=40.13, PRR=40.13, IC=5.16, EBGM=35.78), and serpiginous choroiditis (ROR=31.07, PRR=31.07, IC=4.83, EBGM=28.41). Conclusions The clinical manifestations of ocular AE during MMF treatment are diverse, and none of them are recorded in the drug label. The clinical outcomes are poor and can lead to blindness, which should be vigilant in clinical practice.
  • Yu Lihong, Zhao Ting, Ma Wenming
    Adverse Drug Reactions Journal. 2022, 24(7): 387-389. https://doi.org/10.3760/cma.j.cn114015-20220111-00027
    A 31-year-old pregnant woman was treated with progesterone soft capsule 0.2 g vaginally twice daily and nadroparin calcium injection 4 100 U subcutaneously once daily due to threatened abortion at 23+1 weeks of menopause. On the 16th day of treatments, laboratory tests showed alanine aminotransferase (ALT) 766-U/L, aspartate aminotransferase (AST) 411-U/L, γ-glutamyl transferase (γ-GT) 98-U/L, alkaline phosphatase (ALP) 180-U/L, and total bile acid (TBA) 40.1-μmol/L. Liver injury caused by nadroparin calcium was considered. The drug was stopped and liver protective treatments were given. On the 21st day of nadroparin calcium withdrawal, the patient had inevitable abortion and delivered a dead baby through vagina. Laboratory tests showed ALT 83 U/l, AST 103 U/l, γ-GT 37-U/L, ALP 157-U/L, and TBA 42.0-μmol/L. Liver protective treatments were continued After 35 days of nadroparin calcium withdrawal, laboratory tests showed ALT 18-U/L, AST 15-U/L, γ-GT 33-U/L, ALP 156-U/L, and TBA 6.2-μmol/L.
  • 调查研究
    Zhou Ying;Liang Yan;Lu Yunlan
    . 2001, 3(4): 222-226.
    Objective: To introduce renal failure by Mutong and the way of its prevention and treatment. Methods: 17 cases of the renal failure by Mutong in our hospital were collected to analyze the clinical characteristics and causes of the adverse reactions. Results: Mutong and the compound Mutong preparations probably caused renal failure after long-term administration and overdosage. Conclusion: Great care could be required of appropriate dosage, treatment course and correct indications in order to assure the efficacy and safe use of the drug.
  • Zhang Qingxia, Wang Yawei, Li Xiaoling, Wang Yuqin, Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, Chinese Pharmacological Society Professional Com
    Adverse Drug Reactions Journal. 2020, 22(9): 499-504. https://doi.org/10.3760/cma.j.cn114015-20200728-00818

    In 2019, a total of 15 056 cases of medication error (ME) from 234 hospitals in 24 provincial administrative regions were collected in the National Monitoring Network for Clinical Safe Medication. The number of hospitals reporting ME increased by 32.20% compared with that in 2018 (177 hospitals), and the number of reported cases increased by 28.02% compared with that in 2018 (11 761 cases). In 15 056 cases of ME reports, 52 (0.35%) were classified as grade A, 11 175 (74.22%) as grade B, 3 351 (22.26%) as grade C, 350 (2.32%) as grade D, 79 (0.52%) as grade E, 44 (0.29%) as grade F, 0 as grade G, 4 (0.03%) as grade H, and 1 (0.01%) as grade I. Among the 15 004 patients involved in ME of grade B‑I, 8 801 (58.66%)were male and 6 203 (41.34%) were female; the age of these patients ranged from 1 day to 103 years, 2 027 patients (13.51%) were <18 years old, 7 377 patients (49.17%) were ≥18 to <60 years old, and 5 600 patients (37.32%) were ≥60 years old. Serious MEs (grade E‑I) involved 128 patients, of whom 65 (50.78%) were aged over 60 years. The top 3 drugs involved in serious MEs were insulin glargine, methotrexate tablets, and warfarin tablets. The 52 cases of grade A MEs did not involve person who triggered the MEs and places where MEs occurred. In the 15 004 cases of grade B‑I MEs, 9 821 (65.46%) were triggered by physicians, 3 561 (23.73%) by pharmacists, 634 (4.23%) by nurses, 306 (2.04%) by patients and their family members, and 2.04% (4.54%) by other persons; the proportion of MEs triggered by physicians and patients and their family members were higher than those in 2018 (60.89% and 1.06%), respectively; 5 662 (37.74%) occurred in the clinics, 4 001 (26.67%) in hospital wards, 3 721 (24.80%) in the pharmacies, 1 084 (7.22%) in pharmacy intravenous admixture services, 224 (1.49%) in the nurse stations, 133 (0.89%) in patients′ houses, 4 (0.03%) in the community health service stations, and 175 (1.17%) in other places; the proportion of MEs in pharmacy intravenous admixture services and patients′ houses were higher than those in 2018 (5.52% and 0.41%), respectively. The top 3 contents of MEs were wrong drug class, wrong usage, and wrong single dose. The top 3 persons who discovered the MEs were pharmacists, nurses, and physicians. The top 3 factors cau- sing MEs were lack of related pharmacologic knowledge, tiredness, and insufficient training of medical workers.

  • Sun Pengpeng, Zhang Hui, Jiang Yumin, Wang Jingdong, Zhang Meng
    Adverse Drug Reactions Journal. 2022, 24(9): 497-499. https://doi.org/10.3760/cma.j.cn114015-20220211-00112
    A 69-year-old male patient was treated with nivolumab combined with tegafur-gimeraci- loteracil potassium due to gastric adenocarcinoma with liver, pancreas, and abdominal lymph node metastasis after completing 4 cycles of chemotherapy with oxaliplatin and raltitrexed. Ten days later, the patient developed severe rashes all over the body, which was considered to be adverse skin reactions caused by nivolumab and tegafur-gimeracil-oteracil potassium. Then the 2 drugs were stopped and treatments with methylprednisolone and antiallergic drugs were given. The rashes were gradually improved, the dose of glucocorticoid was reduced gradually, and it was stopped at last. However, on the day of glucocorticoid withdrawal, the patient developed fever, chills, and severe respiratory failure. In combination with clinical treatment, laboratory test results, and imaging changes in the patient, it was considered to be immune-related pneumonitis caused by nivolumab. Methylprednisolone, anti-infection, and high-flow nasal cannula oxygen therapy were given. Four days later, the asthma symptoms in the patient were obviously improved, and 28 days later, the pulmonary CT showed the pneumonitis was markedly improved than before.
  • Cai Jun, Li Huixin, Shu Qing, Nie Li, Han Dan, Zhang Jinping
    Adverse Drug Reactions Journal. 2021, 23(3): 128-133. https://doi.org/10.3760/cma.j.cn114015-20201202-01149
    Objective To establish the Chinese version of Medication Appropriateness Index (MAI) and evaluate the appropriateness of medication in elderly inpatients on trial. Methods According to Brislin′s translation model for cross-cultural research, the MAI was translated into Chinese through 4 steps: translation, back translation, cultural adaptation, and pre-survey. Using convenient sampling method, 300 elderly inpatients in the Department of Geriatrics, Nanjing Drum Tower Hospital from July to December 2019 were selected as the research subjects, and the Chinese version of MAI was used to evaluate the appropriateness of medication. Reliability of the Chinese version of MAI was evaluated using Cronbach′s α coefficient and intraclass correlation coefficient (ICC); the content validity and structural validity of the Chinese version of MAI were evaluated using 4-level scoring method and exploratory factor analysis, respectively. The appropriateness of medication in 300 elderly inpatients was evaluated by analyzing the MAI scores and the distribution of irrational items. Results The Chinese version of MAI contained 10 items. The evaluation results of 300 elderly inpatients were statistically analyzed. The Cronbach′s α coefficient of the scale was 0.892 and the ICC of the scale was 0.876 when 20 patients were selected for re-testing 14 days later. The item-level content validity index (I-CVI) of the Chinese version of MAI was 0.86 to 1.00 and the scale-level content validity index/average (S-CVI/Ave) was 0.96. A total of 4 common factors were extracted by explo- ratory factor analysis, the cumulative variance contribution rate was 58.132%, and the factor loading of 8 items was more than 0.4. The evaluation results of appropriateness of medication showed that the average MAI score in 300 patients was 2.6, of which 198 patients did not score 0; inappropriate medication counted 66.00% and the average MAI score of each drug was 0.2. The top 3 items with more inappropriate medication were drug-disease/abnormal condition interaction (88 cases, 29.3%), duplication (69 cases, 23.0%), and incorrect dosage (67 cases, 22.3%). Conclusions The Chinese version of MAI had good reliability and validity. The items with more inappropriate medication in elderly inpatients in the Department of Geriatrics, Nanjing Drum Tower Hospital were mainly drug-disease/abnormal condition interaction, duplication, and incorrect dose.
  • Ma Lulu, Zhang Xiuhua
    Adverse Drug Reactions Journal. 2022, 24(8): 393-395. https://doi.org/10.3760/cma.j.cn114015-20220520-00450
    The rational application of analgesics to control postoperative pain is an important measure to improve the efficacy of surgical treatment and the quality of life and prognosis of patient.The multi-mode analgesia, preventive analgesia, and the perioperative goal-oriented whole process analgesia management were recommended to control postoperative pain in relevant guidelines at home and abroad. However, irrational use of modes of analgesia and/or analgesics is still common and some patients are not satisfied with postoperative pain management. It is of high clinical significance to provide patient education with analgesic method and drug use before operation, enhance the continued medical education about postopera- tive pain management for doctors in related clinical departments, set up acute pain service management group at the hospital level for improvement of the satisfaction of postoperative analgesia, rational use of analgesics, and the prognosis of patients.
  • Wei Juanjuan, Lin Yang, Shi Xiujin
    Adverse Drug Reactions Journal. 2021, 23(2): 63-68. https://doi.org/10.3760/cma.j.cn114015-20200807-00852
    Objective To compare the occurrence and clinical characteristics of hypersensitivity reactions induced by 3 non-ionic iodine contrast media (NICMs) during percutaneous coronary intervention (PCI). Methods The patients who developed hypersensitivity reactions in iopromide, iohexol, and iodixanol application during PCI were screened out from adverse drug reaction reports of Beijing Anzhen Hospital from January 1, 2013 to December 31, 2018 and the total number of patients who underwent the PCI during that period and received the above NICMs was obtained by searching the hospital information system. The overall incidences of hypersensitivity reactions and severe hypersensitivity reactions and incidences of those induced by each of the 3 NICMs were calculated and their clinical characteristics were analyzed. Results The overall incidences of hypersensitivity reactions and severe hypersensitivity reactions induced by the 3 NICMs were 0.603% (422/69-955) and 0.024% (17/69-955). The incidences of hypersensitivity reactions induced by iohexol, iopromide, and iodixanol were 0.418% (109/26-097), 0.364% (83/22-787), and 1.092% (230/21-071), respectively; the incidences of severe hypersensitivity reactions were 0.023% (6/26-097), 0.039% (9/22-787), and 0.009% (2/21-071), respectively. Iodixanol had a higher incidence of hypersensitivity reactions than iopromide and iohexol (both P<0.001) but the lowest incidence of severe hypersensitivity reactions, which was significantly different from that of iopromide (P=0.047). Of the 422 patients who developed hypersensitivity reactions, 327 were male and 95 were female with an average age of 59 years (range: 27-101 years). The time of hypersensitivity reactions occurrence was recorded in 373 patients and time from NICMs injection to hypersensitivity reactions occurrence were 30-minutes to 90-hours with the median time of 5 hours; hypersensitivity reactions were immediate type (latency ≤1 hour) in 127 patients (34.0%) and delayed type (latency>1 hour) in 246 patients (66.0%). The hypersensitivity reactions induced by iopromide were mainly immediate type (79.5%, 62/78), while those induced by ioxamol were mainly delayed type (87.7%, 193/220). The proportion of patients with a previous history of allergy in the immediate type patients was significantly higher than that in the delayed type patients [15.0% (15/100) vs. 7.1% (14/197), P=0.030]. The most common clinical manifestation of hypersensitivity reactions was rash [78.0% (329/422)]. Among 17 cases of severe hypersensitivity reactions, 15 (88.2%) were anaphylactic shock, 1 was laryngeal edema, and 1 was dyspnea, all of which were immediate type. Hypersensitivity reactions were all improved after treatments, but PCI failed to be fully performed in 6 patients due to severe hypersensitivity reactions. Conclusions The safety of 3 NICMs for PCI was good and the incidence of hypersensitivity reactions was low; the incidence of severe hypersensitivity reactions due to iopromide was the highest. Severe hypersensitivity reactions such as anaphylactic shock might affect the performance of PCI and caution should be given.
  • 安全合理用药
    Geng Tongchao①;Shi Jianxiong②
    . 2007, 9(4): 251-255.
    Migraine is one of the most common disorders in neurological clinic.New advances in pathogenesis and drug therapy for migraine have been obtained in recent years.This paper presents the drug therapy for migraine including treatment of acute attacks and preventive therapy.The common drugs used to treat acute migraine attacks are nonsteroidal non-inflammatory drugs,triptans,ergot alkaloids,etc.And the drugs used for preventive therapy are tricycle antidepressants,anticonvulsants,β-blockers,calcium channel blockers,etc.This article reviews the therapeutic actions and potential adverse reactions of these drugs in order to benefit the safe and rational drug use in clinical practice.
  • Deng Jianhao, Zhang Jiaxing, Zhuang Qian
    Adverse Drug Reactions Journal. 2022, 24(5): 239-245. https://doi.org/10.3760/cma.j.cn114015-20211022-01091
    Objective To evaluate the cardiovascular safety of febuxostat and allopurinol in patients with gout/hyperuricemia, and to explore the difference in cardiovascular safety between Asian and non-Asian patients. Methods Randomized controlled trials (RCTs) and cohort studies of comparision of cardiovascular safety between febuxostat (the trial group) and allopurinol (the control group) in the treatment of gout/hyperuricemia were collected by searching related databases at home and abroad (up to October, 2021). The outcome indicators were the incidences of acute decompensated heart failure (ADHF), stroke, acute coronary syndrome (ACS), coronary revascularization, death from cardiovascular causes, and all-cause death. The Cochrane collaboration risk of bias risk tool and Newcastle Ottawa Scale were used to evaluate the quality of the RCTs and the cohort studies, respectively. RevMan 5.4-software was used for meta-analysis, and the effect sizes were relative risk (RR) and its 95% confidence interval (CI). Results A total of 9 RCTs and 7 cohort studies were enrolled in the analysis and 385-700 patients were involved, including 123-565 in the trial group and 262-135 in the control group. The results of quality evaluation showed that there were 4 and 5 RCTs with low and uncertain bias risk in 9 RCTs, respectively; among the 7 cohort studies, 2 and 5 were of high and medium quality, respectively. The result of meta-analysis of RCTs showed that the incidence of ADHF in the trial group was significantly lower than that in the control group [1.37% (77/5-620) vs. 2.21% (102/4-607), RR=0.74, 95%CI: 0.55-0.99, P=0.04]. The result of meta-analysis of cohort studies showed that the incidence of stroke in Asian patients in the trial group was lower than that in the control group [0.87% (519/59-559) vs. 0.90% (810/89-836), RR=0.94, 95%CI: 0.75-1.17, P=0.58]; the incidence of stroke in non-Asian patients in the trial group was lower than that in the control group, and the difference was statistically significant [1.49% (377/25-306) vs. 1.70% (1-305/76-864), RR=0.88, 95%CI: 0.78-0.98, P=0.02]; the incidence of cardiovascular death in Asian patients in the trial group was higher than that in the control group [0.96% (473/49-373) vs. 0.68% (335/49-368), RR=1.41, 95%CI: 1.23-1.62, P<0.01]. Conclusions The risk of ADHF caused by febuxostat is lower than that caused by allopurinol; the risk of stroke caused by febuxostat is lower than that caused by allopurinol in non-Asian patients; the risk of cardiovascular death caused by febuxostat is higher than that caused by allopurinol in Asian patients.
  • Ma Yuanyuan, Chen Zhibin, Wang Tan
    Adverse Drug Reactions Journal. 2021, 23(3): 163-164.
    A 47-year-old female patient received compound polyethylene glycol electrolytes powder (III) 4 bags (73.59 g/bag) dissolved in 4 L warm water in 16 divided doses to prepare for colonoscopy the next day. The patient took medicated warm water 2 L within 2 hours. She had loose stool and watery stool for more than 10 times within 1 hour after medication. The patient did not continue to take drugs because of the severe diarrhea. Fourteen hours after medication, the patient developed apathy, no response to voice stimuli, and involuntary movement of both upper limbs. Sixteen hours after medication, the patient developed unconsciousness and tetanic convulsion of limbs. Laboratory tests showed that serum sodium was 120-mmol/L and plasma osmolality was 258.22 mOsm. She was diagnosed with hyponatremia encephalopathy. Except polyethylene glycol electrolytes powder (III), the patient did not take any other drug. It was considered that hyponatremia encephalopathy was related to polyethylene glycol electrolytes powder (III). Symptomatic treatments such as sodium supplement and dehydration were given immediately. After 1 hour of treatment, the patient′s consciousness recovered; 8 hours later, her serum sodium was 142-mmol/L.
  • Zhou Nan, Guo Guiping, Mao Lichao, Guan Yue
    Adverse Drug Reactions Journal. 2020, 22(10): 597-598. https://doi.org/10.3760/cma.j.cn114015-20200218-00132
    A 51-year-old male patient received an operation treatment for paranasal sinusitis induced by radiotherapy and chemotherapy of nasopharyngeal carcinoma. One oxycodone and acetaminophen tablet (each tablet contains oxycodone hydrochloride 5-mg and acetaminophen 325-mg) was given orally thrice daily before and after the operation. Pregabalin 75-mg twice daily was added because of the poor analgesic effectiveness. During the treatment, oral oxycodone hydrochloride 10-mg was given once daily by his family members for 2 days. Two days after the addition of pregabalin, the patient developed mental disorders, such as delirium, irritability, involuntary convulsions of limbs, cognitive impairment, and disorientation. All above-mentioned analgesics were discontinued and dexmedetomidine was given for pain relief and sedation. Three days later, the mental state of the patient was improved, there was no obvious delirium, the discrimination and orientation returned to normal, and dexmetomidine was discontinued. There was an obvious time correlation between the occurrence and disappearance of mental disorders and the combination of analgesic drugs. Referring to the previous literature, it was considered that the mental disorders of the patient were caused by the interaction between oxycodone and pregabalin.
  • Tang Jie, Luo Li, Wang Rui, Liu Zhihui
    Adverse Drug Reactions Journal. 2020, 22(7): 434-435. https://doi.org/10.3760/cma.j.cn114015-20190311-00231
    A 34-year-old female patient received an intramuscular injection of compound amionpyrine antipyrine barbitone injection for acute upper respiratory infection and fever. Eight hours after medication, the patient developed deep yellow urine followed by fatigue, anorexia, and yellowish skin. Laboratory tests showed alanine aminotransferase (ALT) 764-U/L, aspartate aminotransferase (AST) 211-U/L, alkaline phosphatase (ALP) 280-U/L, gamma-glutamyltransferase (γ-GT) 861-U/L, total bilirubin (TBil) 72.0-μmol/L, direct bilirubin (DBil) 61.3-μmol/L, and indirect bilirubin (IBil)10.7-μmol/L. The patient was diagnosed as having drug-induced liver injury, which might be related to compound amionpyrine antipyrine barbitone injection. Therapy with liver-protective drugs was given immediately. Sixteen days later, her jaundice subsided. The laboratory tests showed ALT 58-U/L, AST 34-U/L, ALP 237-U/L, γ-GT 345 U/L, TBil 26.0-μmol/L, and DBil 13.1-μmol/L.
  • Adverse Drug Reactions Journal. 2020, 22(3): 188-193. https://doi.org/10.3760/cma.j.cn114015-20200225-00167
    目的 对利巴韦林和干扰素α的不良事件(AE)进行数据挖掘,为鉴别应用这两种药物治疗新型冠状病毒肺炎(新冠肺炎)过程中出现的临床症状/体征和实验室检查异常是药物引起还是疾病本身所致提供依据。 方法 根据文献及《新型冠状病毒肺炎诊疗方案(试行第五版)》中提到的新冠肺炎症状/体征及实验室检查异常结果选出本研究关注的AE。收集2004年1月1日至2019年12月31日美国FDA不良事件报告系统(FAERS)相关数据,采用报告比值比(ROR)法对利巴韦林和干扰素α进行数据挖掘。 结果 设定时段内FAERS数据库共收到7-582-463份药物相关的有效AE报告,其中利巴韦林31-775份,干扰素α 2-345份。分析结果显示,在呼吸系统、胸及纵隔疾病中可能与利巴韦林具有相关性的AE有鼻充血、咳嗽、喉疼痛、咽部水肿、咳痰和呼吸困难,可能与干扰素α具有相关性的AE有喉疼痛和咯血;在其他系统器官分类中可能与利巴韦林和干扰素α均具有相关性的AE包括发热、寒冷感、疲乏、恶心、呕吐、腹泻、头痛、关节痛、肌痛和皮疹。在实验室检查异常AE中,与利巴韦林相关的有白细胞计数降低、血小板计数降低、天冬氨酸转氨酶升高和丙氨酸转氨酶升高;与干扰素α相关的有白细胞计数降低、淋巴细胞计数降低、血小板计数降低、天冬氨酸转氨酶升高和丙氨酸转氨酶升高。 结论 利巴韦林和干扰素α相关AE中一部分与新冠肺炎的临床表现和实验室检查异常结果相似,临床实践中应当注意鉴别。
  • Qiu Xuejia, Cao Gexi, Tian Dongdong, Zhang Yue, Lian Yufei
    Adverse Drug Reactions Journal. 2020, 22(4): 221-226. https://doi.org/10.3760/cma.j.cn114015-20190212-00136
    Objective To systematically evaluate cardiotoxicity of programmed cell death 1 receptor (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitors. Methods Clinical trials of PD-1/PD-L1 inhibitor alone or in combination with other treatments for tumors were collected by searching related databases at home and abroad (up to March 2, 2019). The methodological quality of studies was evaluated using the internationally accepted Cochrane collaboration′s risk of bias assessment tool. A meta-analysis was performed using RevMan 5.3 software to compare the incidences of cardiotoxicity between PD-1/PD-L1 inhibitors (trial group) and placebo or other antineoplastic agents(control group). Results A total of 10 randomized controlled trials (RCTs) were enrolled, 9 of which were about PD-1 inhibitor alone or in combination with other antineoplastic agents, and 1 of which was about PD-L1 inhibitor monotherapy. There were a total of 5-291 patients, including 3-022 in the trial group and 2-269 in the control group. Evaluation of the methodological quality for studies showed that 4 RCTs were at high risk of bias and the other 6 were at low risk of bias. The meta-analysis showed that the incidence of cardiotoxicity in the trial group was significantly higher than that in the control group, and the difference was statistically significant[1.13% (34/3-022) vs. 0.22% (5/2-269), RR=2.38, 95%CI: 1.19-4.78, P=0.01]. Conclusion PD-1/PD-L1 inhibitors have the risk of causing heart related adverse events, which should be paid attention to in clinical application.
  • Tang Minqiong, Zhu Pengli
    Adverse Drug Reactions Journal. 2022, 24(9): 500-502. https://doi.org/10.3760/cma.j.cn114015-20220126-00082
    A 73-year-old female patient received monotherapy with pembrolizumab (IV infusion of 200-mg once every 3 weeks) for lung cancer with bone metastases. On day 12 after the 6th treatment with pembrolizumab, the patient developed severe nausea and vomiting. Laboratory tests showed random blood glucose 53.6-mmol/L and serum potassium 6.8-mmol/L. Blood gas analysis showed pH 7.3, partial pressure of carbon dioxide 19.5-mmHg, partial pressure of oxygen 15.6-mmHg, base excess -8.9-mmol/L, bicarbonate 9.5-mmol/L, lactic acid 2.5-mmol/L, and anionic gap 23.5-mmol/L. Blood ketone body test was positive. The patient had no previous history of diabetes mellitus, fulminant type 1 diabetes mellitus and ketoacidosis due to pembrolizumab were considered. Pembrolizumab were stopped and rehydration, hypoglycemia, acidosis correction, and other symptomatic treatments were given. Seven days later, her symptoms were improved partly. Laboratory tests showed fasting blood glucose 12.9-mmol/L and serum potassium 4.5-mmol/L. Blood gas analysis showed pH 7.5, bicarbonate 28.3-mmol/L, and base excess +5.7-mmol/L. Blood ketone body test was negative.
  • Adverse Drug Reactions Journal. 2023, 25(6): 383-384. https://doi.org/10.3760/cma.j.cn114015-20230615-00441
  • Li Tianzuo
    Adverse Drug Reactions Journal. 2020, 22(5): 280-282. https://doi.org/10.3760/cma.j.cn114015-20200427-00471
    Dexamethasidine (DEX) is an alpha-2 adrenoreceptor (α2-AR) agonist, which is not only used in the perioperative period, but also in outpatient examination or treatment. The characteristics and advantages of sedation and hypnosis with DEX are that patients can enter a state similar to natural sleep, which is not only beneficial to improve the sedation effect, but also easy to wake up, and there is little jaw relaxation and no obvious respiratory inhibition. The additional advantages of DEX lie in its function of anti-stress response and potential organ protection and its little influence on cognitive function. The main adverse reactions of DEX were temporary hypertension, hypotension, bradycardia, and so on. Another characteristic of DEX is the relatively slow disappearance of drug effect. Patients may have drowsiness and postural hypotension after operation. It must be noted that DEX cannot be used as an independent anesthetic in general anesthesia to act as the main analgesic and sedative, but only to play an auxiliary role, which depends on the reasonable use and dosage and is not "all" or "none". And the vital signs of patients must be closely monitored during the process of DEX application.
  • 安全合理用药
    Luo Ling;Li Qinglin;Liu Jinggen
    . 2008, 10(6): 0-0.
    Selective serotonin reuptake inhibitors (SSRIs) are a widely used newer class of antidepressants, which can treat different types of depression. The commonly used SSRIs are fluoxatine, paroxetine, sertraline, fluvoxamine, and citalopram. The SSRIs can cause various types of adverse reactions. The main adverse reactions are gastrointestinal disorders, withdrawal reactions, sexual disturbances, and syndrome of inappropriate secretion of antidiuretic hormone (SIADH), etc. SSRIs may increase the risk of suicidal thinking and behaviour in children and adolescents, but the issue remained controversial. The recent studies have suggested that exposure to SSRIs early in pregnancy appeared to be no increase in the risk of congenital malformations; however, exposure to SSRIs late in pregnancy may incresae the risk of pulmonary hypertension and withdrawal reactions of the newborn. In general, breastfeeding with SSRIs is regarded as safe because the amount of drug is very low in breast milk. But the possibility of longterm effects on development in the infant is unknown. As for the elderly, SSRIs may increase the risk of fracture. Adverse reactions resulting from interations of SSRIs with some drugs are given below. MAOIs: serotonin syndrome; diuretics: severe hyponatremia; anticoagulants: increased risk of bleeding; NSAIDs: increased risk of upper gastrointestinal bleeding; tryptophan: serotonin syndrome; astemizole, terfenadine: ventricular arrhythmias and Q-T interval prolongation; haloperidol, maprotiline: severe extrapyramidal symptoms; lithium increase in plasma lithium concentration and lithium toxicity. Overall, SSRIs have fewer adverse effects than tricyclic antidepressants, but the SSRIs do have characteristic adverse reactions of their own. Therefore, doctors should exercise caution when prescribing SSRIs to patients in clinical practice.
  • Liu Jiancheng, Ma Xin, Chen Zhesi, Ling Zesha, Wang Wenchun
    Adverse Drug Reactions Journal. 2021, 23(1): 41-42. https://doi.org/10.3760/cma.j.cn114015-20200401-00344
    A 79-year-old male patient was given an IV infusion of piperacillin sodium and tazobactam sodium 4.5 g once every 8 hours for head injury complicated by Escherichia coli pneumonia. Before the treatment, his white blood cell count (WBC) was 10.20×109/L, red blood cell count (RBC) was 3.58×1012/L, hemoglobin (HB) was 101-g/L, and platelet count (PLT) was 202×109/L. On day 2 of medication, his blood cell count began to decrease, with the lowest values of WBC 2.96×109/L, RBC 2.40×1012/L, Hb 66-g/L, and PLT 128×109/L, respectively. It was misdiagnosed as gastrointestinal bleeding because of positive occult blood in gastric juice of the patient at the same time. However, the patient had no obvious melena, his gastric fluid occult blood did not match the development of anemia, and there was no evidence of hemolysis or hemorrhage at other sites. The relationship between the blood cell count decrease and piperacillin sodium and tazobactam sodium was considered. The drug was discontinued and the patient′s blood cell count returned to levels before treatment 3 days later.
  • Lu Xiaoyan, Dai Youqin, Wu Yamiao, Yang Sijia, Zou Junyong, Chen Wei
    Adverse Drug Reactions Journal. 2020, 22(9): 550-552. https://doi.org/10.3760/cma.j.cn114015-20190708-00548
    A 64-year-old male patient with colon cancer received one cycle chemotherapy of oxaliplatin+capecitabine and 7 cycles of oxaliplatin+raltitrexed chemotherapy. There were no interstitial changes in chest CT before operation. After 8 cycles of chemotherapy, the patient deve- loped chest tightness and shortness of breath. Chest CT showed interstitial changes in bilateral lungs, which were considered to be related to oxaliplatin. After 31 days of treatments with drugs such as broad-spectrum antibiotics, glucocorticoids, acetylcysteine, and reduced glutathione, as well as noninvasive ventilator assisted ventilation, oxygen inhalation, and other symptomatic treatments, his symptoms of chest tightness and shortness of breath were relieved, and chest CT showed that interstitial lesions in the bilateral lungs were obviously relieved.
  • Dong Yuan, Dong Zhiqiang
    Adverse Drug Reactions Journal. 2023, 25(7): 441-443. https://doi.org/10.3760/cma.j.cn114015-20220622-00556
    A 63-year-old male patient with hepatocellular carcinoma received sintilimab (200-mg by IV infusion on day 1, 21 days as one cycle) after surgery. After 3 cycles of treatment, the patient developed unclear speech, mental fatigue, drowsiness, and weight loss. Laboratory tests showed triiodothyronine (T3) 0.54-nmol/L, thyroxine (T4) 13.0-nmol/L, thyroid-stimulating hormone (TSH) 98.62 mU/L, free triiodothyronine (FT3) 0.43-pmol/ml, free thyroxine (FT4) 0.25-pmol/L, cortisol (Cor) (8:00) 6.1-nmol/L, adrenocorticotropic hormone (ACTH) (8:00) 0.22-pmol/L/L. He was diagnosed as having immune-related hypothyroidism and adrenal cortex hypofunction, which was caused by sintilimab. After 4 days of treatments with glucocorticoid, the above symptoms in the patient were improved, and levothyroxine was given. The dosage of glucocorticoids given to patients was gradually reduced.After 11 days of treatments with levothyroxine, the laboratory tests showed that the thyroid function returned to normal, and levothyroxine was stopped. Adrenal cortex function was still lower than normal [Cor (8:00) 51.6-nmol/L,ACTH (8:00) 0.22-pmol/L]. Then prednisone acetate tablets 5-mg once daily orally were given continuously. At 8 months of follow-up, the adrenal cortex function in the patient remained low, and sintilimab was stopped forever.
  • Wang Chunhui, Li Qianwen, Wu Wei, Li Xiaoyu, Lyu Qianzhou
    Adverse Drug Reactions Journal. 2020, 22(10): 595-596. https://doi.org/10.3760/cma.j.cn114015-20190926-00787
    A 49-year-old male patient was treated with first-line and second-line chemotherapy regimens successively for 7 months because of Hodgkin′s lymphoma. However, the tumor failed to be well controlled. His treatment was changed to intravenous infusion of sintilimab 200-mg once every 21 days. His liver function was normal before treatment. After the second administration of sintilimab (on day 42 after the first medication), the patient developed chest distress, abdominal distension, poor appetite, and etc. Reexa- mination of liver function showed alanine aminotransferase (ALT) 1-590-U/L, aspartate aminotransferase (AST) 3-678-U/L, alkaline phosphatase (ALP) 468-U/L, gamma-glutamyl transferase (γ-GT) 399-U/L, total bilirubin (TBil) 50.1-μmol/L, and direct bilirubin (DBil) 26.8-μmol/L. Sintilimab was discontinued, but the patient′s jaundice was deteriorated. Intravenous infusion of methylprednisolone 150-mg once daily was given for 3 days, but the bilirubin reached the peak (TBil 152.6-μmol/L,DBil 109.2-μmol/L). Oral mycophenolate mofetil 0.5 g twice daily was added, the patient′s symptoms were gradually improved, and his liver function gradually recovered. After 6 days of combination use of methylprednisolone and mycophenolate mofetil, the laboratory tests showed ALT 63-U/L, AST 78-U/L, TBil 25.2-μmol/L, and DBil 12.9-μmol/L. Twenty-two dags later, his liver function returned to normal.
  • Zhang Qingxia, Wang Yawei, Li Xiaoling, Wang Yuqin, Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, et al
    Adverse Drug Reactions Journal. 2021, 23(5): 228-234. https://doi.org/10.3760/cma.j.cn114015-20210506-00532
    In 2020, a total of 15-849 cases of medication error (ME) from 255-hospitals in 24 provincial administrative regions were collected in the National Monitoring Network for Clinical Safe Medication. The number of hospitals reporting ME increased by 8.97% compared with that in 2019 (234-hospitals), and the number of reported ME cases increased by 5.27% compared with that in 2018 (15-056 cases). In 15-849 cases of ME reports, 54 (0.34%) were classified as grade A, 12-297 (77.59%) as grade B, 3-010 (18.99%) as grade C, 358 (2.26%) as grade D, 72 (0.45%) as grade E, 52 (0.33%) as grade F, 0 as grade G, 5 (0.03%) as grade H, and 1 (0.01%) as grade I. Among the 15-795 patients with ME of grade B to I, 9-347 (59.18%) were male and 6-448 (40.82%) were female, aged from 1 day to 101 years; 1-714 (10.85%) were children (<18 years old), 8-355 (52.90%) were middle aged patients (≥18 to <60 years old), and 5-726 (36.25%) were elderly patients (≥60 years old). Among the 130 patients with serious ME (grade E-I) that caused injury, 77 (59.23%) were male and 53 (40.77%) were female, aged from 4 months and 14 days to 94 years; 16(12.31%) were children, 46(35.38%) were middle aged patients, 68(52.31%) were elderly patients. Among the 9 patients with serious ME caused by mistaken use of drugs, 7 were children, accounting for 43.75% (7/16) of all children with serious ME. The 54 grade A MEs did not involve person who triggered the MEs and place where MEs occurred. Among the 15-795 grade B-I MEs, 10-748 (68.05%) were triggered by physicians, 3-797 (24.04%) by pharmacists, 578 (3.66%) by nurses, 329 (2.08%) by patients and their family members, and 343 (2.17%) by other persons; the proportion of MEs triggered by patients and their family members increased year by year for 3 consecutive years (1.06% and 2.04% in 2018 and 2019, respectively), and 49.23% (64/130) of severe ME were triggered by patients and their family members; 6-830 (43.24%) occurred in clinics, 3-808 (24.11%) in hospital wards, 3-776 (23.91%) in pharmacies, 985 (6.24%) in pharmacy intravenous admixture services, 220 (1.39%) in the nurse stations, 161 (1.02%) in patients′ houses, 2 (0.01%) in the community health service stations, and 13 (0.08%) in other places; the proportion of MEs occurred in clinics and patients′ houses increased year by year for 3 consecutive years (37.32% and 0.41% in 2018, 37.74% and 0.89% in 2019, respectively). The top 3 contents of MEs were wrong drug class, wrong usage, and wrong quantity. The top 3 persons who discovered the MEs were pharmacists, physicians, and nurses. The top 3 factors causing MEs were lack of related pharmacologic knowledge, tiredness, and insufficient training of medical workers.
  • Gao Wenjuan, Li Pengmei, Zhao Li
    Adverse Drug Reactions Journal. 2021, 23(6): 293-297. https://doi.org/10.3760/cma.j.cn114015-20210207-00162
    Objective To explore the occurrence of adverse reactions of empagliflozin in hospitalized patients with type 2 diabetes mellitus. Methods Medical records of all patients who were treated with empagliflozin during hospitalization in China-Japan Friendship Hospital from May 1 to December 31, 2020 were collected through the hospital information system. According to the main adverse reactions indicated in the label of empagliflozin, the occurrence of urinary tract infection, hypoglycemia, and hypotension after the application of empagliflozin was retrospectively analyzed. According to the Handbook of Adverse Drug Reaction Reporting and Monitoring in China, the causality between drugs and adverse reactions was evaluated, and those adverse events that were certainly, probably, and possibly related to empagliflozin were judged as empagliflozin-related adverse reactions. Results A total of 718 inpatients received empagliflozin treatment during the study period, including 517 males and 201 females, with age of (59±12) years. The doses of empagliflozin were all 10-mg orally once daily. The treatment time was (7±3) days and the length of hospital stay was (8±4) days. Among 718 patients, 17 (2.4%) experienced adverse reactions possibly related to empagliflozin, including 11 (1.5%) with urinary tract infection (all showing asympto- matic bacteriuria), 4 (0.6%) with hypoglycemia, and 2 (0.3%) with hypotension. There were 8 males and 9 females among the 17 patients with adverse reactions, and the incidence of adverse reactions in females was significantly higher than that in males [4.5% (9/201) vs. 1.5% (8/517), χ2=5.376, P=0.020]. Among the 11 patients with urinary tract infection, 4 were male, 7 were female, and the incidence of urinary tract infection in females was significantly higher than that in males [3.5% (7/201) vs. 0.8% (4/517), χ2=7.040, P=0.008]. In the medical records of the 17 patients, the above-mentioned adverse reactions were all not documented as related to empagliflozin, and were all not reported as adverse drug reactions. Conclusions The adverse reactions related to empagliflozin in hospitalized patients with type 2 diabetes mellitus were urinary tract infection, hypoglycemia, and hypotension. The prevention of urinary tract infection should be strengthened, especially in female patients. The awareness of clinical medical staff on the adverse reactions of empagliflozin needs to be improved.
  • Ma Shuangshuang, Xu Yunshan, Shen Wei
    Adverse Drug Reactions Journal. 2020, 22(8): 492-493. https://doi.org/10.3760/cma.j.cn114015-20190318-00277
     A 26-year-old female patient took oral methimazole 20-mg twice daily due to hyperthyroidism. More than a month later, she developed spastic pain of limb muscles. Laboratory tests showed alanine aminotransferase (ALT) 45-U/L, aspartate aminotransferase (AST) 121-U/L, creatine kinase (CK) 6-090-U/L, and serum potassium 4.1-mmol/L. The dose of methimazole was reduced to 10-mg once daily, but the patient′s myalgia was not improved after 3 days. Adverse reactions due to methimazole were considered and therefore the drug was discontinued. Four days after drug withdrawal, the patient′s myalgia was obviously relieved, and laboratory tests showed ALT 36-U/L, AST 50-U/L, and CK 1-954-U/L. After 18 days of drug withdrawal, her myalgia disappeared, and the ALT, AST, and CK returned to normal.
  • Niu Xiaoqiang, Cheng Linzhong
    Adverse Drug Reactions Journal. 2020, 22(12): 693-694. https://doi.org/10.3760/cma.j.cn114015-20200309-00237
    A 48-year-old female patient received compound Congrong Yizhi capsules 1.2 g (4 capsules) orally thrice daily for memory decline. About 20 days later, the patient developed nausea, anorexia, yellow urine, and yellow staining of skin and sclera. Compound Congrong Yizhi capsules were discontinued. Seven days after drug withdrawal, laboratory tests showed that alanine aminotransferase (ALT) was 1-349-U/L, aspartate aminotransferase (AST) was 827-U/L, alkaline phosphatase (ALP) was 156-U/L, and total bilirubin (TBil) was 213.7-μmol/L. Liver injury induced by compound Congrong Yizhi capsules was considered. Reduced glutathione, compound glycyrrhizin, ademetionine 1,4-butanedisulfonate, and dexa- methasone were given. The patient′s appetite was gradually improved and jaundice gradually subsided. After 36 days of treatments, ALT was 26-U/L, AST was 30-U/L, ALP was 86-U/L, and TBil was 27.2-μmol/L. The liver injury of the patient was considered to be related to Radix Polygoni Multiflori Preparata (prepared fleeceflower root) in compound Congrong Yizhi capsules.
  • 读者·作者·编者
    . 2006, 8(4): 312-314.
  • Dong Xu, Lai Yanbo, Feng Tao
    Adverse Drug Reactions Journal. 2020, 22(12): 703-704. https://doi.org/10.3760/cma.j.cn114015-20200229-00188
    A 32-year-old female patient received long-term use of paroxetine 40-mg/d orally for depression. Because of uncontrolled behavior, the patient took paroxetine about 1-000-mg at one time. About 24-hours after taking the medicine, the patient developed cough and expectoration, followed by dyspnea, and 2 days later, the patient became unconscious. The partial pressure of oxygen was 38-mmHg, and the partial pressure of carbon dioxide was 43-mmHg. Chest CT showed ground glass opacities in bilateral lungs, indicating interstitial pulmonary edema. Acute lung injury and respiratory failure were diagnosed. Then mechanical ventilation via a tracheal cannula, continuous intravenous pumping of methylprednisolone 160-mg/d, and symptomatic treatments such as anti-infection, fluid infusion, correction of acid-base imbalance were given. Her respiratory condition was gradually improved, and the partial pressure of oxygen gradually returned to normal; 5 days later, the ventilator was stopped and the tracheal tube was removed.
  • Lu Cuicui, Li Weizhe, Shen Shan, Zhang Wen
    Adverse Drug Reactions Journal. 2021, 23(4): 196-201. https://doi.org/10.3760/cma.j.cn114015-20201119-01153
    Minocycline is a semi-synthetic tetracycline antibiotic. In recent years, minocycline has been used in the treatment of chronic infections caused by multi-drug resistant bacteria and chronic diseases such as pemphigus and rheumatoid arthritis due to its lower incidence of bacterial resistance and good antibacterial effect. Long term use of oral minocycline can cause skin hyperpigmentation. According to the location, clinical features, and histopathological changes, minocycline-induced skin hyperpigmentation (MISH) is divided into 4 subtypes, but the definition of subtype 4 remains controversial. The incidence of MISH varies greatly in different studies, which may be closely related to factors such as patients′ underlying pathophysiological status, comorbid diseases, dose, and duration of treatment. For those patients who need to take minocycline for a long time, skin color should be observed. Once skin color changes were found, relevant examinations (e.g. skin biopsy) should be carried out in time to make a definite diagnosis as soon as possible. Patients with MISH should pay attention to sun protection. Reducing the dose or stopping minocycline is an effective strategy to improve MISH. Q-switched laser or picosecond laser is recommended to treat pigmentation which can not be recovered after drug withdrawal.
  • 滥用误用
    Yu Yinjiao
    . 2008, 10(5): 0-0.

    Smoking is one of major causes leading to death and more than five million people die from smoking each year worldwide. It has become a serious public health problem. Studies have been identified that there are more than 4000 compounds in tobacco and tobacco smoke. Among them at least 43 compounds are carcinogens. Regular smoking can cause a number of diseases like cancer, emphysema, heart disease, organ damage as well as dependence (addiction). The dependence is mainly caused by nicotine containing in tobacco. Most regular smoking are addicted to nicotine. So regular smokers stopping smoking may induce nicotine withdrawal symptoms including irritability, restlessness, dizziness, headache, difficulty sleeping, and inability to concentration. Most smokers who fail to succeed in quitting smoking is mainly related to the nicotine addiction. In view of this fact, a nicotine replacement therapy (NRT) was advanced. NRT is a way of getting nicotine slowly into the body without smoking. This help people not only to stop or reduce the symptoms of nicotine withdrawal, but also avoid the hazards from smoking. The results from the various studied have showed that NRT increase the rate of success in quitting smoking, and the risk for dependence to NRT product is small. NRT medicines are available as gums, patches, inhalers, sprays, and so on. All dosage forms of NRT medicines have adverse reactions. The severity of adverse reactions are generally mild, but their types differ across NRTs. The common adverse reactions are dizziness, headache, nausea, vomiting, and gastrointestinal discomfort. NRT can safely used for pationts with cardiovascular disease. NRT is not recommended for pregnant women, nursing mothers, and adolescents. In a word, nicotine replacement therapy is safe and effective in helping smokers stop using cigarettes. NRT products have been used in many countries worldwide as OTC. It is worthy of recommendation.

  • Yan Xuelian, Huang Qian, Ge Nan, Sun Wenjuan, Zhang Bo, Wang Kai
    Adverse Drug Reactions Journal. 2020, 22(11): 631-637. https://doi.org/10.3760/cma.j.cn114015-20200112-00026
    Objective To explore the clinical characteristics of immune checkpoint inhibitor- related pneumonitis (CIP) caused by pembrolizumab. Methods We reported a case of CIP caused by pembro- lizumab admitted in Peking Union Medical College Hospital and searched case reports on CIP caused by pembrolizumab in PubMed, Embase, ScienceDirect, CNKI, VIP, and Wanfang databases (as of October 1, 2019). The main clinical data (gender, age, primary diseases, use of pembrolizumab, combination drugs, time to onset of CIP, symptoms, imaging results, CIP grade, and treatment and outcome) in all reported cases were collected and analyzed. Results A total of 33 patients were enrolled, including 23 males and 10 females, aged from 44 to 91 years with a median age of 64 years. The primary diseases in 11 cases were melanoma, in 9 cases were lung adenocarcinoma, in 4 cases were lymphoma, in 3 cases were colon cancer, and in 6 patients were esophageal cancer, breast cancer, nasopharyngeal cancer, pulmonary pleomorphic carcinoma, pulmonary large-cell neuroendocrine carcinoma, and lung squamous cell cancer, respectively. Thirty patients received pembrolizumab as monotherapy, 1 patient received combination therapy of pembrolizumab with carboplatin and pemetrexed, and 2 patients received pembrolizumab combined with radiation therapy. Time to onset of CIP in the 33 patients was 1 day at the shortest and 2 years at the longest with a median time of 12(4, 16) weeks. The symptoms of CIP mainly were dyspnea in 19 cases, cough and expectoration in 15 cases, and fever in 9 cases. The common radiological features were ground glass opacities in 17 cases, consolidations in 11 cases, and grid-like high-density shadow in 8 cases. After the diagnosis of CIP, all patients stopped using pembrolizumab. Twenty-nine patients were treated with glucocorticoids, 19 patients received antibacterial therapy, 2 patients received human immunoglobulin, 1 patient received infliximab, and 2 patients did not receive any intervention. Of the 30 patients with known clinical outcomes, 24 patients were improved and 6 died. Among the improved patients, 6 patients underwent rechallenge with pembrolizumab and 1 of them developed CIP again. Conclusions The clinical symptoms and radiologic features of CIP caused by pembrolizumab are lack of specificity. Constant vigilance for the presences of fever and respiratory symptoms within 12 weeks after pembrolizumab treatment is required. The CIP in most patients can be improved after drug withdrawal and additional use of glucocorticoids, but the potential fatal risk of CIP is still need to be alert to.
  • 药物评介
    . 2002, 4(4): 278-280.
  • Li Caiyun, Xie Cheng, Zhang Xiaolan
    Adverse Drug Reactions Journal. 2023, 25(4): 250-252. https://doi.org/10.3760/cma.j.cn114015-20220524-00459
    A 23-year-old healthy male received subcutaneous injection of recombinant human granulocyte colony-stimulating factor injection (rhG-GSF) 600-μg once daily for 6 days before allogeneic hematopoietic stem cell transplantation as a donor. Before medication, there were no abnormalities in the patient′s coagulation markers, blood routine and biochemical tests, as well as electrocardiographic examination. Seven days after discontinuation of the drug, the patient developed sudden chest pain, sweating, and vomiting. Laboratory tests showed high sensitivity cardiac troponin T 3 144-ng/L, creatine kinase MB>300 μ G/L, myoglobin 505.6-μg/L, N-terminal pro-brain natriuretic peptido 1-138-ng/L, white blood cell count 17.7×109/L, platelet count 160×109/L. The electrocardiogram showed ST segment elevation myocardial infarction. A dual antiplatelet therapy of aspirin and ticagrelor was administered in conjunction with percutaneous transluminal coronary angioplasty. After surgery, anticoagulation, antiplatelet, and lipid-lowering treatments were given. On the 3rd day after surgery, the patient developed toe pain, fever, and a platelet count of 382×109/L, symptoms were gradually relieved after symptomatic treatment, but platelet count increased to 566×109/L. After consultation with hematologists and rheumatologists, combined with relevant laboratory test indicators, autoimmune and hematological system-related diseases were excluded. It was considered that coronary artery thrombosis and thrombocytosis may be related to the use of rhG-CSF, and platelet count gradually decreased to 275×109/L without special treatment. During the follow-up of 7 months, his platelet count was 235×109/L .
  • Zhang Xianglin
    Adverse Drug Reactions Journal. 2021, 23(10): 535-541. https://doi.org/10.3760/cma.j.cn114015-20210416-00467
    Rituximab is a human-mouse chimeric monoclonal antibody synthesized using genetic engineering technology and exert pharmacological effects by specifically binding to the transmembrane protein CD20 on the surface of B cells. The clinical therapeutic effect of rituximab is significant, but its pharmacological mechanism is complex, the pharmacokinetics/pharmacodynamics (PK/PD) presents as nonlinear models and is highly variable, which brings great variability and uncertainty to the effectiveness and safety of rituximab in clinic, so individualized therapy needs to be implemented to improve the rationality of medication. At present, rituximab has the basic conditions for therapeutic drug monitoring (TDM), such as detection technology of blood drug concentration, tumor biomarkers, and related genetic polymorphisms. Using these technologies, combined with comprehensive analysis of factors such as disease diagnosis, population specificity, route of administration, and drug interactions, the PK/PD model of rituximab can be constructed to predict the efficacy, toxicity, and drug resistance. It is of great significance for pharmacists to participate in the individualized rituximab treatment and carry out TDM, which can provide safer and more effective individualized treatment for patients.
  • Li Yanhua, Tian Xu, Liu Guangchen, Zhang Hongmei
    Adverse Drug Reactions Journal. 2021, 23(7): 377-378. https://doi.org/10.3760/cma.j.cn114015-20201203-01206
    A 60-year-old male patient was hospitalized due to acute attack of bronchial asthma and pneumonia and antitussive, antiasthmatic, and anti-inflammatory treatments was given. Then his symptoms were improved. Discharge medication included budesonide and formoterol fumarate powder for inhalation and montelukast sodium. On the 4th day of medication after discharge, the patient developed bilateral metatarsophalangeal joint pain with redness and swelling, abdominal distension, fatigue, and dark urine. Laboratory tests showed serum creatinine (Scr) 112-μmol/L, serum uric acid 228-μmoL/L, urine protein (+), and urine occult blood (++). Gout, rheumatoid arthritis, and other autoimmune diseases were excluded and the possibility of acute kidney injury and metatarsophalangeal joint pain related to montelukast sodium was considered. Montelukast sodium was discontinued, budesonide and formoterol fumarate powder for inhalation was continued, and symptomatic treatment was given at the same time. Seven days later, the pain of metatarsophalangeal joint was improved and the urine color returned to normal. Two weeks later, his Scr level returned to normal (75-μmol/L).
  • Feng Yanhua, Xu Zhenhua
    Adverse Drug Reactions Journal. 2021, 23(12): 651-652. https://doi.org/10.3760/cma.j.cn114015-20210126-00111
    A female infant aged 7 months and 29 days received an IV infusion of ceftriaxone sodium for injection (ceftriaxone sodium) 0.5 g dissolved in 0.9% sodium chloride injection 100-ml once daily because of acute diarrhea, moderate dehydration, and myocardial injury. Symptomatic treatments such as maintaining water and electrolyte balance and nourishing myocardium were given at the same time. Her platelet count (PLT) was 269×109/L before treatment. On day 4 of treatments, the laboratory test showed that her PLT was 893×109/L. Infection-induced thrombocytosis was considered and ceftriaxone sodium was continued at the original dose. On day 6 of treatments, her PLT was 931×109/L; on day 8 of treatments, her PLT increased to 1-018×109/L. It was considered that the increase of PLT might be related to ceftriaxone sodium. Ceftriaxone sodium was stopped and anticoagulant therapy was given. Six days later, her PLT decreased to 359×109/L; 19 days later, the PLT decreased to 224×109/L.
  • Adverse Drug Reactions Journal. 2020, 22(3): 121-129. https://doi.org/10.3760/cma.j.cn114015-20200309-00211
     2020年3月3日,国家卫生健康委员会发布《新型冠状病毒肺炎诊疗方案(试行第七版)》,提出抗病毒药物治疗方案、中医中药治疗方案及免疫治疗等。临床一线专业人员如何依据患者的病理、生理状况和药物的药理特性选择药物以及治疗中需要监测的指标,亟需明确和权威的学术支持。为此,中国药师协会治疗药物监测药师分会等11个学术团体联合编写了“新型冠状病毒肺炎及常见合并症药物治疗与药学监护指引”,期望为一线医师、药师和护士提供参考。
  • Tang Xiting, Xie Guilong
    Adverse Drug Reactions Journal. 2020, 22(10): 589-590.
    A 55-year-old male patient with hepatic complex alveolar echinococcosis, who had a history of gout for more than 4 years, developed swelling and high skin temperature of feet when he waited for the result of remote consultation and prepared for optional right hemihepatectomy in the hospital. Laboratory tests showed that uric acid was 530-μmol/L and rheumatic factor was negative. Acute gout attack was considered. He was treated with oral colchicine 0.5-mg thrice daily. About 10-hours after the first administration, the patient developed urinary incontinence. According to the consultation results, it was considered that the urinary incontinence might be related to colchicine. Colchicine was stopped immediately. The symptoms of urinary incontinence disappeared 24-hours after drug withdrawal. The symptoms of urinary incontinence recurred after the patient took the drug again by himself. Urinary incontinence did not recur after the colchicine withdrawal again.
  • 中毒救治
    Wang Ying;Qiu Zewu
    . 2007, 9(3): 190-192.
    Ricin derived from castor beans is a potent toxin, the main machanism of its toxic effects to cells is to inhibit protein synthesis in cells and result in their death. People can be poisoned via different routes of exposure to ricin. The clinical presentations of ricin poisoning depend on the route of exposure and the dose received. The patients with severe ricin poisoning may develop multi-organ failure and death. So for no specific antidote exists for ricin. The toxin vaccine of ricin is being tried out on laboratory animal. Treatment for ricin poisoning is primarily supportive medical care to minimize the effects of the poisoning.
  • Weng Xiuhua, Huang Xiaojia, Huang Yaping, Cheng Bo
    Adverse Drug Reactions Journal. 2022, 24(12): 652-657. https://doi.org/10.3760/cma.j.cn114015-20220512-00417
    Objective To investigate the clinical characteristics of pemphigoid caused by immune checkpoint inhibitors (ICIs). Methods The relevant databases at home and abroad (up to October 15, 2021) were searched and the case reports on pemphigoid caused by ICIs were collected. The relevant information of patients (gender, age, tumor type, drug varieties of ICIs, incubation period of pemphigoid, main symptoms, distribution site of lesions, biopsy and immunological examination, treatment and outcome, etc.) were collected and analyzed descriptively. Results A total of 82 relevant literature were included, involving 103 patients, 72 males and 31 females, aged 30-90 years, of which 82 (79.6%) were ≥60 years old. The primary diseases were melanoma in 45 cases (43.7%) and lung cancer in 29 cases (28.2%). The 103 patients involved 6 varieties of ICI, including programmed cell death 1 receptors [pablizumab (47 cases, 45.6%), navulizumab (44 cases, 42.7%), and terepril (4 cases, 3.9%)], and programmed cell death ligand 1 inhibitors [atezumab (3 cases, 2.9%), duvalizumab (2 cases, 1.9%)], and CTLA-4 inhibitor ipimamab (3 cases, 2.9%). Eighty-four patients had a record of the time from the beginning of ICI to the occurrence (incubation period) of pemphigoid. The incubation period of pabolizumab was 3-850 days, of navulizumab was 21-790 days, and of terepril was 70-728 days. Among 103 patients, 88 (85.4%) were bullous pemphigoid, 8 (7.8%) were mucous pemphigoid, 4 (3.9%) were non bullous pemphigoid, and 1 (1.0%) was dyshidrosiform pemphigoid; the clinical manifestations were bullous and vesicular lesions in 98 cases (95.1%), rash in 51 cases (49.5%), and pruritus in 48 cases (45.6%). Nine four patients had skin biopsy results, 78 patients (83.0%) had eosinophil infiltration in the lesion site; immunological examination was performed in 92 cases (97.8%), of which 63 cases (68.5%) were IgG and C3 deposits. Thirty-five patients had pemphigoid associated antigen test records, BP180 was detected in 25 patients, and 24 patients (96%) were positive; BP180 and BP 230 were detected simultaneously in 8 cases, both were positive in 6 cases, and BP180 was positive and BP 230 was negative in the other 2 cases; BP-Ag2 was detected in 2 cases, all of them were positive. After treatment with glucocorticoid or immunosuppressant and/or withdrawal of ICIs, 86 (83.5%) of 103 patients were improved, and 6 were not; 8 cases died, of which 7 cases of pemphigoid were improved but died of other causes, and 1 case died of unreported causes; 9 cases did not report the outcome. Conclusions ICIs can cause pemphigoid, and the incidence in the elderly is higher. The incubation period of pemphigoid varies from 3 days to more than 2 years. After glucocorticoid or immunosuppressant treatment and/or withdrawal of ICIs, most patients had good prognosis.
  • Zhu Chao, Gong Chunyan
    Adverse Drug Reactions Journal. 2021, 23(2): 110-111. https://doi.org/10.3760/cma.j.cn114015-20200509-00516
    A 26-year-old woman received laser decolorization therapy for facial freckles. After the operation, compound arbutin cream 1 g once per night was applied on the face. She developed redness, swelling, and water blisters with desquamation on her face about 12-hours after the first application of the drug. She was diagnosed as having contact dermatitis, which was considered to be related to compound arbutin cream. Then the cream was withdrawn. She received prednisone acetate 20-mg orally once daily, levocetirizine 5-mg orally once per night, and local hydropathic compress with 3% boric acid lotion. Three days later, her facial redness, swelling, and desquamation were obviously improved, and most of the water blisters disappeared. At a one-week telephone follow-up, the patient′s water blisters disappeared.
  • 安全用药
    . 2004, 6(1): 27-31.
    对乙酰氨基酚被认为具有较好的安全性而广泛用于感冒引起的发热、头痛以及各种疼痛的治疗。但其不良反应时有发生,并且大剂量使用易引起肝损害。因此,对乙酰氨基酚的安全性与合理使用问题有必要加以讨论。
  • Ma Suwen, Sun Zheng, Shao Yueying, Du Xiangying, Lu Jie
    Adverse Drug Reactions Journal. 2020, 22(10): 603-605. https://doi.org/10.3760/cma.j.cn114015-20191210-01000
    A 69-year-old female patient with diabetes mellitus was scheduled to undergo angiography of head because of acute cerebral infarction. When iopromide injection-370 was injected intravenously with a high-pressure syringe before operation, the contrast medium extravasated at the injection site of her right hand, resulting in severe subcutaneous hematoma, tissue necrosis, and infection. The maximum area of extravasation wound extended to 6.0-cm × 7.0-cm. Therapies such as local wet compress with cold 50% magnesium sulfate and dexamethasone, daily debridement and dressing change, and external application of hydrogel, silver containing hydrophilic foam, and hydrocolloid were given. On day 14 after extravasation, the necrotic tissue of the wound gradually fell off and the wound began to heal. Then the wound healed on day 35 after extravasation.
  • Liu Jinchun, Yan Xiaomin
    Adverse Drug Reactions Journal. 2022, 24(12): 667-669. https://doi.org/10.3760/cma.j.cn114015-20220324-00245
    A 38-year-old female patient with thyroid nodule received Xingqi Sanjie cream 30 g orally twice daily for 4 treatment courses in total. Each treatment course was 1 month and the interval between the 2 courses was 14 days. On the 29th day of the 4th treatment course, the patient developed poor appetite, yellowish skin and sclera, and dark urine. Laboratory tests showed alanine aminotransferase (ALT) 3-201-U/L, aspartate aminotransferase (AST) 2-262-U/L, total bilirubin (TBil) 257.2-μmol/L, direct bilirubin (DBil) 186.9-μmol/L, and alkaline phosphatase (ALP) 159-U/L. Drug-induced liver injury (severe) was diagnosed, which was considered to be related to Xingqi Sanjie cream. The drug was stopped, and symptomatic and supportive treatments including hepatoprotection and rehydration were given. Twenty-two days later, the above symptoms in the patient were improved. Laboratory tests showed ALT 209-U/L, AST 117-U/L, TBil 92.7-μmol/L, DBil 63.2-μmol/L, and ALP 82-U/L. Fifty-one days later, the yellowish skin and sclera in the patient subsided, and the urine color returned to normal. Laboratory tests showed ALT 37-U/L, AST 22-U/L, TBil 30.3-μmol/L, DBil 14.7 μ mol/L, and ALP 58-U/L.
  • Xu Zhiyu, Zhang Aiwu
    Adverse Drug Reactions Journal. 2022, 24(4): 223-224. https://doi.org/10.3760/cma.j.cn114015-20211203-01221
    A 63-year-old female patient was treated with 30 Mugua pills and Zhuifeng Tougu pills 6 g twice daily for tenosynovitis. After taking the medicine for 10 days, the patient developed nausea and vomiting, which were aggravated gradually; after taking the medicine for 22 days, the patient had fever, nausea, retching, slight pain in the upper abdomen, systemic edema, skin pruritus, and poor spirit, appetite, and sleep. Laboratory tests showed alanine aminotransferase (ALT) 454-U/L, aspartate aminotransferase (AST) 946-U/L, alkaline phosphatase (ALP) 133-U/L, gamma glutamyltransferase (γ-GT) 170-U/L, direct bilirubin (DBil) 12.8-μmol/L, and glutamate dehydrogenase 17.3-U/L. Viral hepatitis and biliary obstruction were excluded by laboratory tests and imaging examination. Drug-induced liver injury was diagnosed, Mugua pills and Zhuifeng Tougu pills were stopped, and diisopropylamine dichloroacetate injection and compound glycyrrhizin tablets were given. Liver function was gradually improved in the patient and laboratory tests showed ALT 62-U/L, AST 49-U/L, γ-GT 38-U/L, and DBil 7.2-μmol/L 12 days later. The medication was adjusted to 3 compound glycyrrhizin tablets thrice daily for 2 weeks. After 4 weeks, laboratory tests showed ALT 31-U/L, AST 26-U/L, γ-GT 30-U/L, and DBil 5.0-μmol/L.
  • Xiong Guangmei, Yang Hui, Chen Shuqiao, Jiang Hao
    Adverse Drug Reactions Journal. 2023, 25(2): 125-128. https://doi.org/10.3760/cma.j.cn114015-20220222-00141
    A 67-year-old male patient with small cell lung cancer was given chemotherapy combined with immunotherapy (irinotecan+nedaplatin+tislelizumab), 21 days as a cycle. The patient′s cough was significantly improved without blood in sputum. After 2 cycles of treatment, chemotherapy and immunotherapy were suspended because of grade Ⅳ bone marrow suppression, and radiation therapy was changed. After the 29th radiotherapy, the patient developed paroxysmal cough and sputum with bloody, accompanied by shortness of breath and no fever. Blood gas analysis showed type Ⅰ respiratory failure. Chest computed tomography (CT) showed new pleural reticular vague shadows in both lungs, especially in the right lung. Radiotherapy was stopped and chemotherapy was restarted. The patient's cough and expectoration were improved, but the shortness of breath gradually aggravated. The interstitial pneumonia lesions involved both lungs rather than being localized, by which radiation pneumonitis were ruled out. Virus and atypical pathogen infection were excluded by etiology and imaging examination. Immune-related pneumoniatis complicated with infection caused by tislelizumab was considered. High-dose methylpre- dnisolone combined with gamma globulin and infliximab were given to inhibit immune response, mero- penem, moxifloxacin, voriconazole were given successively to prevent infection, and oxygen inhalation was given. The patient′s cough, expectoration, and shortness of breath disappeared, oxygenation index was improved, and chest CT showed that the range of interstitial changes in both lungs gradually reduced.
  • Wang Xiaomeng, Lin Xiaolan, Zhuang Wei
    Adverse Drug Reactions Journal. 2022, 24(1): 3-6. https://doi.org/10.3760/cma.j.cn114015-20211218-01273
    Traditional Chinese medicine (TCM) is widely used in medical institutions in China. Because TCM is often regarded as "natural and non-toxic", the irrational use of TCM is more common, such as repeated medication, incompatibility, long-term prescription, inappropriate usage and dosage, and inapprop- riate drug combination. The development and application of TCM prescription pre-audit system is of great significance to the safety management of TCM, but the existing TCM decoction prescription audit system still has some defects and needs to be further improved. The safety of TCM can be further improved by setting up TCM clinical pharmacist post, and strengthening the monitoring of adverse reactions and the study of the interaction between TCM and western medicines. In medical institutions, the management measures of TCM safety should be constantly explored and the pharmaceutical service level of TCM should be improved to ensure the patient safety.
  • Song Yan, Xu Lingyi, Zhao Simiao, Zheng Xizi, Yang Li
    Adverse Drug Reactions Journal. 2024, 26(11): 641-646. https://doi.org/10.3760/cma.j.cn114015⁃20240831⁃00027
    Anticancer drugs are important causes of kidney injury in cancer patients. Once kidney injury occurs, it will affect anticancer therapy and patient prognosis. Thus, the Japanese Society of Nephro- logy, Japan Society of Clinical Oncology, Japanese Society of Medical Oncology, and Japanese Society of Nephrology and Pharmacotherapy have jointly formulated the Clinical Practice Guidelines for Management of Kidney Injury During Anticancer Drug Therapy 2022 and made a particular discussion on the prevention and management of anticancer drug-induced kidney injury. This article focuses on interpreting the management of kidney injury related to cytotoxic anticancer drugs, targeted therapies, and immune checkpoint inhibi-tors to more effectively guide clinical practice.
  • . 2017, 19(6): 409.
  • Wang Yan, Zhao Xinyan, Jia Jidong
    Adverse Drug Reactions Journal. 2023, 25(4): 243-247. https://doi.org/10.3760/cma.j.cn114015-20220801-00695
    Immune checkpoint inhibitors (ICIs) play the role of anti-tumor by activating the immune system in human, but they can also cause immune-mediated liver injury, which is different from conventional drug-induced liver injury in the incidence, clinical manifestations, pathogenesis, and prognosis. The main pathogenesis is that ICIs block key nodes of negative regulation of the immune response, including cytotoxic T-lymphocyte-associated antigen 4 and programmed cell death 1 receptor/programmed cell death ligand 1. Liver-injury occurs when the immune system is overactivated and loses immune tolerance to the liver. Immune-mediated liver injury includes immune-mediated hepatitis and immune-mediated cholangitis. Histopathological examination of the liver shows damage in hepatocytes and bile ducts, accompanied by central venous dermatitis mostly and granulomatous lesions partially. After diagnosis of immune-mediated liver injury, treatment should be given based on the severity, and glucocorticoids or immunosuppressants are often necessary.
  • Liu Yonghong, Chen Xiaoping, Shuai Ying
    Adverse Drug Reactions Journal. 2021, 23(9): 493-494. https://doi.org/10.3760/cma.j.cn114015-20210105-00013
    A 68-year-old male patient with type 2 diabetes mellitus received saxagliptin, metformin, and voglibose for 10 months, voglibose was switched to acarbose due to poor blood glucose control firstly and then to empagliflozin (oral 10-mg thrice daily) 2 days later. Next day,compound tropicamide eye drops was used to mydriasis and 3 hours later (2 hours after the second administration of empagliflozin), the patient developed scattered red wheal like rash with pruritus on the chest and abdomen, followed by eyelid edema. Considering allergy to compound tropicamide eye drops, loratadine and cetirizine were given, the rash gradually subsided, but the skin pruritus increased. Diffuse red macules and papules, which faded from pressure, gradually appeared on his trunk and upper limbs. Allergic dermatitis caused by empagliflozin was considered after consulting the dermatologist, empagliflozin was discontinued, fexofenadine and calamine lotion were added, and the rash subsided. Due to the patient′s condition, empagliflozin was readministered 3 days later, and the patient experienced a skin allergic reaction again 9 days after the treatment. Empagliflozin was stopped again and the rash did not recur after anti-allergic treatment. It was considered that the patient′s skin allergic reaction was possibly related to empagliflozin.
  • Liu Haiyan, Miao Qiuli, Song Yanqing, Wang Xiangfeng
    Adverse Drug Reactions Journal. 2021, 23(7): 384-386. https://doi.org/10.3760/cma.j.cn114015-20201123-01167
    A 62-year-old female patient with stomach cancer received an IV infusion of oxaliplatin and mannitol injection on day 1 and oral tegafur, gimeracil, and oteracil potassium on days 1-14 in a 21-day cycle after radical mastectomy. Pretreatment with dexamethasone and other drugs was given 3 hours before the infusion to alleviate possible adverse reactions. During the 1st cycle of chemotherapy, the patient had no other adverse reaction except nausea and fatigue, and no intervention was given. About 2 hours after oxaliplatin and mannitol injection in the 2nd cycle, the patient′s limbs were swollen and flushed, and red patches appeared on the skin. Then the erythema increased and merged into patches and her skin on the feet was desquamated. The above symptoms were improved after anti-allergic treatments. About 3 hours after oxaliplatin and mannitol injection in the 3rd cycle, the patient developed dyspnea, and systemic skin flushing and swelling accompanied by scratches. Then visible blisters on part of the skin appeared, which cracked at the flexion of the joints with exudate impregnation. The patient was given anti-allergic therapy such as prednisolone. Four days later, her skin on the whole body showed scaly desquamation, her hands and feet showed gloved desquamation, and she was diagnosed as having exfoliative dermatitis; 9 days later, her skin color became lighter and there was no new rash. Considering that exfoliative dermatitis was caused by oxaliplatin and mannitol injection, the chemotherapy regimen was switched to docetaxel (day 1) and tegafur, gimeracil, and oteracil potassium (days 1-14). The skin allergic reactions did not recur.
  • Yan Lina, Zhang Haifeng, Cui Mancang, Wu Lili
    Adverse Drug Reactions Journal. 2023, 25(9): 543-550. https://doi.org/10.3760/cma.j.cn114015-20230328-00232
    Objective To mine the risk signals of echinococcin antifungal drugs such as caspofungin-, micafungin-, and anidulafungin-related adverse events(AEs) and provide reference for their safe and rational use in clinical practice. Methods AE reports of caspofungin, micafungin and anidulafungin from January 1, 2004 to June 30, 2021 were collected by searching the US FDA Adverse Event Reporting System database. AEs were classified and standardized according to the system organ class (SOC) and the preferred terms (PT) of Medical Dictionary for Regulatory Activities 25.0. Reported odds ratio (ROR) method was used to mine the AE risk signals of above mentioned 3 drugs. An AE with reports ≥3 and 95% confidence interval (CI) lower limit of ROR>1 was defined as a positive signal. Results A total of 1-348 AE reports of caspofungin were collected, involving 73 PTs and 13 SOCs. The top 5 PTs in signal intensity were dilatation intrahepatic duct acquired, myoglobin urine present, retinitis, renal abscess, and hypoperfusion, all of which were new adverse reactions which were not recorded in the labels. A total of 837 AE reports of micafantine were collected, involving 39 PTs and 11 SOCs. The top 5 PTs in signal intensity were hepatoblastoma, leukaemoid reaction, blood creatine increase, acidosis, and skin necrosis all of which were new adverse reactions not recorded in the labels. A total of 202 AE reports of anidulafungin were collected, involving 22 PTs and 12 SOCs. The top 5 PTs in signal intensity were rectal obstruction, venous occlusive liver disease, anuria, supraventricular tachycardia, and acute respiratory distress syndrome. Except the acute respiratory distress syndrome, the other adverse reactions were new adverse reactions not recorded in the labels. Conclusions The AEs of the 3 echinocandin antifungal drugs mined in this study are mostly new adverse reactions not recorded in the labels, involving liver and biliary system, blood and lymphatic system, kidney and urinary system diseases mainly, which should be vigilant in clinical practice.
  • Adverse Drug Reactions Journal. 2020, 22(3): 130-138. https://doi.org/10.3760/cma.j.cn114015-20200223-00152
    本共识分别从新型冠状病毒肺炎疫情防控期间居家隔离药物治疗的必要性和意义、居家消毒剂的选择和合理应用、医院处方药的相关规定、长期居家药物治疗的管理等多个维度,为大众居家期间的合理用药提供指导和帮助。
  • Wang Lianshuang, Bai Li, Yu Jing, Wang Liping, Wang Xuemei, Xiang Pan, Gao Xuesong, Zhang Yao
    Adverse Drug Reactions Journal. 2020, 22(6): 355-359. https://doi.org/10.3760/cma.j.cn114015-20200509-00506
    Objective To report the clinical features of pulmonary hypertension diagnosed by echocardiography in 5 patients with novel coronavirus pneumonia (COVID-19) in order to understand the special clinical manifestations of COVID-19 and explore the possible mechanism. Methods The echocardiographic data and clinical characteristics of COVID-19 patients complicated with pulmonary hypertension diagnosed by echocardiography in Beijing Ditan Hospital, Capital Medical University were analyzed descriptively from February 5 to March 31, 2020. Results A total of 15 patients with severe and critical COVID-19 patients underwent echocardiography. Of them, 7 patients were diagnosed with pulmonary hypertension, 5 of which were confirmed as complications of COVID-19. Among the 5 patients, 4 were female and 1 was male, aged 62-78 years; 4 were with hypertension, 3 were with diabetes, and 1 was with coronary atherosclerotic heart disease. All 5 critically ill patients with COVID-19 were given ventilator-assisted breathing, 2 of which were given extracorporeal membrane oxygenation at the same time. According to echocardiography, the systolic pressure of pulmonary artery in 5 patients was 43-65-mmHg, with an average of 54-mmHg. The severity of pulmonary hypertension was graded as mild in 1 patient and moderate in 4 patients. During the follow-up, pulmonary artery systolic pressure gradually decreased to normal in 4 patients, and then ventilator and ECMO were withdrawn; 1 patient died due to respiratory failure and persistent pulmonary hypertension. Conclusions Patients with COVID-19 may be complicated by pulmonary hypertension, which is often found in the critical patients. Echocardiography is an important imaging diagnostic method for pulmonary hypertension in patients with COVID-19.
  • Liu Yanru, He Yanju
    Adverse Drug Reactions Journal. 2021, 23(10): 544-545. https://doi.org/10.3760/cma.j.cn114015-20201222-01270
    A 53-year-old female patient received IV infusion of meropenem for injection 1.0 g once every 8 hours for urinary tract infection. Her platelet count (PLT) was 151×109/L before using meropenem. On the 9th day of meropenem treatment, the laboratory test showed PLT 577×109/L and on the 12th day, the patient′s infection was controlled but PLT increased to 829×109/L. The thrombocytosis related to meropenem was considered. Meropenem was stopped and replaced by IV infusion of piperacillin sodium and sulbactam sodium for injection 5 g dissolved in 100-ml of 0.9% sodium chloride injection once 8 hours. Three days later, the patient′s PLT decreased to 782×109/L; 23 days later, PLT was 272×109/L.
  • 论著
    Cheng Xuyang①;Wang Mei①;Jiang Ruifeng②
    . 2004, 6(3): 156-160.
    Objective: To investigate the clinical characteristics of antibacterials-induced neuropsychiatric symptoms in patients with chronic renal failure. Methods: Patients with chronic renal failure treated with antibacterials, during January 1999 and December 2001,were retrospectively analysed. Results: 12 patients with chronic renal failure developed antibacterials- induced neuropsychiatric symptoms, 6 males and 6 femals, with a mean age of 64.3±9.7 years. After receiving intravenous injection daily for 1-6 days, patients presented with progressive neuropsychiatric symptoms, including extra-pyramidal system symptoms, disorientation, depressed consciousness, even coma, or apathy, agitation, hallucination, and personality changes. The very common drug involved was cephalosporins, the others were penicillins, carbopenems, quinolones and isoniazid. After withdrawal of evil agents, the neuropsychiatric symptoms disappeared within a few days. Conclusion: Antibacterial agents can cause neuropsychiatric symptoms in patients with chronic renal failure. Physicians should be aware of these potentially dangerous neurotoxicity during performing anti-infection therapy and withdrawal of the drugs whenever the adverse effects occur.
  • Liu Lanlan, Zhao Juanjuan
    Adverse Drug Reactions Journal. 2020, 22(5): 317-318. https://doi.org/10.3760/cma.j.cn114015-20190121-00054
    A 62-year-old female patient received oral aspirin enteric-coated tablets 100-mg once daily, clopidogrel hydrogen sulphate tables 75-mg once daily, metoprolol tartrate tablets 18.75-mg twice daily, and rosuvastatin calcium tablets 10-mg once daily after coronary artery stent implantation regularly according to the doctor′s instructions. Several days later, the patient developed edema of hands and feet from the distal end to the proximal end of the extremities, and he developed facial edema with rash and pruritus at the edema site. After 3 days of antiallergic treatment, there was no obvious regression of edema and new rash. After careful inquiry, the patient said that he always developed edema and increased rash symptoms about 2 hours after taking metoprolol tartrate tablets. After discontinuation of metoprolol tartrate tablets for 1 day, and other drugs were continued to be used, the patient′s edema and rash were relieved on the next day, and the above symptoms reappeared when the drug was used again according to the doctor′s instructions on the same day. When the drug was stopped again, the edema and rash were obviously improved the next day.After 2 days of discontinuation, the patient took metoprolol succinate sustained-release tablets at their own discretion, and still developed edema and rash. After discontinuation of metoprolol succinate sustained-release tablets, the edema and rash disappeared completely 10 days later.
  • . 2017, 19(3): 163.
  • Si Cheng, Ling Li, Zhang Haixia, Wu Xiaoyan, Ge Weihong
    Adverse Drug Reactions Journal. 2024, 26(8): 493-498. https://doi.org/10.3760/cma.j.cn114015‑20240119‑00049
    There is a risk of drug abuse associated with opioid drugs. With the widespread use of opioid drugs in chronic pain, it is of great significance to carry out risk monitoring of opioid drug abuse in medical institutions. This article introduces the relevant terms of opioid drug abuse, summarizes the current situation of opioid drug abuse and the risk situation of drug abuse in medical institutions, introduces the moni- toring tools for opioid drug abuse risks and the issue of discontinuation of drug treatment, and puts forward suggestions for the problems on opioid drug abuse in medical institutions, providing a reference for medical institutions to establish a pharmacovigilance system for drug abuse suitable for national conditions and promote the safe use of opioid drugs.

  • Adverse Drug Reactions Journal. 2023, 25(2): 83-88. https://doi.org/10.3760/cma.j.cn114015-20220801-00697
    Objective To explore the efficacy and safety of fenofibrate combined with ursodeoxycholic acid (UDCA) in the treatment of primary biliary cholangitis (PBC) with poor biochemical response. Methods The medical records of early PBC patients who were diagnosed with poor biochemical response to UDCA and treated with fenofibrate in Outpatient Department of the Liver Research Center of Beijing Friendship Hospital, Capital Medical University from January 2010 to January 2018 were collected and analyzed retrospectively, so as to evaluate the efficacy and safety of combination treatment. The combination treatment regimen consisted of fenofibrate and UDCA. The efficacy indicators were the efficacy rate and biochemical response rate. When the serum alkaline phosphatase (ALP) decreased to below the baseline value before treatment after 12 months of combination therapy, it was  defined as effectiveness, and when it decreased to <1.5 times of upper limit of normal (ULN), the biochemical response was achieved. The safety indicator was the incidence of adverse reactions (liver injury, kidney injury, etc.) related to fenofibrate. Results A total of 42 patients were enrolled in the analysis, including 12 males and 30 females. The age was (53±10) years when fenofibrate was added and the duration of combination therapy was from 5 days to 34 months. The efficacy analysis of 34 patients with combined treatment showed that the average level of ALP decreased from the baseline value after 12 months of treatment, of which 10 patients (29.4%) fell to the reference value range, and the effective rate was 100%. The ALP was 235 (210, 326) U/L before treatment and decreased to 134 (104, 190) U/L after 12 months of treatment, with a statistically significant difference (P=0.001). Of the 34 patients, 25 (73.5%) achieved biochemical response. The ALP before treatment was 221 (198, 256) U/L and decreased to 125 (99, 143) U/L after 12 months of treatment, with a statistically significant difference (P=0.010). Of the 42 patients, 16 (38.1%) developed adverse reactions related to fenofibrate, including liver injury in 8 patients (19.0%, one case was complicated with hearthurn), kidney injury in 4 patients (9.5%), myalgia, facial edema, heartburn, headache, and skin itch with rash in 1 patient each (each 2.3%). Of the 8 patients with liver injury, 4 were mild, 1 was moderate, and 3 were severe; the mild cases were not intervened, and the alanine aminotransferase (ALT) returned to the baseline level after 2 months; in moderate and severe cases, ALT and total bilirubin returned to the baseline level after stopping fenofibrate and receiving liver protection treatment. Of the 4 patients with renal injury, the serum creatinine (Scr) in 2 patients returned to the baseline level after withdrawal of fenofibrate, in the other 2 patients it recovered to the reference value range spontaneously without drug withdrawal. Conclusions Fenofibrate combination with UDCA is effective in the treatment of early PBC patients with poor biochemical response, the rate of biochemical response is 73.5%. The common adverse reactions of fenofibrate are liver injury and kidney injury. During the medication, the patients′ liver and kidney function should be closely monitored.
  • 综述
    . 2002, 4(2): 76-80.
    环境污染的加剧,导致过敏反应相应地增加,由此引伸对第2代组胺H1受体阻断药开发的日趋重视,新药不断上市,其作用强而持久,对中枢和植物神经系统的不良反应甚微,但部分药物对心脏的毒性却日益突出,过量或同时并用肝酶P450抑制剂偶可出现严重的心律失常(尖端扭转型室性心动过速)。为此,对其产生心脏毒性原因及合理应用问题进行探讨,以寻求应用时的防范措施。
  • 安全用药
    . 2003, 5(6): 381-383.
    近年来抗菌药物与乙醇相互作用致双硫仑样反应的发生呈明显增加,本文就此反应发生机制及相关抗菌药物予以分析探讨。其中主要涉及头孢菌素类、硝基咪唑类,以期引起临床医务人员和患者的共同关注,保证用药安全。
  • Li Lin,Liu Wenhui, Liu Yiping, Luo Zhiying
    Adverse Drug Reactions Journal. 2021, 23(8): 447-448. https://doi.org/10.3760/cma.j.cn114015-20201210-01229

    A 76-year-old male patient with small cell lung cancer received EC (etoposide and carboplatin) chemotherapy combined with camrelizumab. On the 22th day of medication, the patient deve- loped chest tightness, shortness of breath, dyspnea, limb weakness, walking difficulty, etc. Laboratory tests revealed creatine kinase (CK) 1-210-U/L and CK-MB 63 U/L. The chemotherapy and immunotherapy were stopped, but the patient′s symptoms continued to worsen. Laboratory tests showed troponin T (TnT) 336-ng/L, CK 1-025-U/L, CK-MB 74-U/L, and N-terminal pro brain natriuretic peptide (NT-proBNP) 648-ng/L. The muscle magnetic resonance imaging (MRI) and electromyogram showed muscle injury and cardiac MRI showed left ventricular fibrosis. Then immune-related skeletal muscle and myocardial injury caused by camrelizumab was considered. The patient received an IV infusion of methylprednisolone sodium succinate for injection 100-mg once daily for 13 days. Then the patient′s fatigue symptoms were improved, the levels of CK and NT-proBNP decreased to the reference range, but the levels of TnT and CK-MB were 491-ng/L and 113-U/L, respectively. Therefore, an intravenous infusion of immunoglobulin 20 g once daily was given. Five days later, his dyspnea was improved, and TNT and CK-MB decreased to 201-ng/L and 59-U/L, respectively.

  • Wang Zhizhou, Dong Xianzhe, Wang Ke, Feng Yingnan, Luo Qiao, Yue Xiaolin, Zhang Lan
    Adverse Drug Reactions Journal. 2023, 25(3): 152-158. https://doi.org/10.3760/cma.j.cn114015-20221101-01015
    Objective To compare the clinical efficacy and safety of cefdinir dispersible tablets selected in the national centralized volume-based procurement (VBP) and the original drug cefdinir capsules. Methods Clinical data of single-use cefdinir in outpatient of Xuanwu Hospital, Capital Medical University between January 1, 2020 and December 31, 2021 were collected through the hospital information system. The clinical data included gender, age, type of medical insurance, type of infection, application of cefdinir, whether to combine other antibacterial drugs, laboratory test results such as blood routine, C-reactive protein, liver and kidney function before and after cefdinir treatment, and adverse reaction report of cefdinir. After propensity score matching (PSM) of the age, sex, type of medical insurance, type of infection and whether to combine with other antibacterial drugs in the cefdinir dispersible tablets group selected in the VBP (VBP group) and the original cefdinir group (original group), the clinical application in patients in the 2 groups was compared to indirectly evaluate the efficacy of the 2 drugs. The white blood cell count, neutrophils percentage, and C-reactive protein levels before and after the use of cefdinir was compared to evaluate the efficacy. Adverse drug reaction report of cefdinir and liver and kidney function before and after the use of cefdinir were compared to evaluate the safety. Results A total of 9-514 patients treated with cefdinir were entered, including 7-037 patients in the VBP group and 2-477 patients in the original group. After PSM, each group comprised 1-268 patients, the differences in gender, age, type of infection, and combination with other antibacterial drugs were not statistically significant (all P>0.05). The daily dose, course, and use density of cefdinir in the VBP group were lower than those in the original group[(0.30±0.04) g vs. (0.35±0.12) g, P<0.001; 8(4, 8) d vs. 10(8, 10) d, P<0.001; (3.96±1.70) g vs. (5.22±2.03) g, P<0.001]. The white blood cell count, neutrophils percentage, and C-reactive protein levels after the cefdinir application in patients in the VBP group were lower than those before the use of the cefdinir [11.2(8.7, 13.8)×109 vs. 7.2(5.5, 9.9)×109, P<0.001; 80(74, 87)% vs. 66(56, 73)%, P<0.001; 23(10, 64) mg/L vs. 13(6, 44) mg/L, P=0.032]. No adverse drug reactions related to cefdinir were reported in the 2 groups. The differences in alanine aminotransferase, aspartate aminotransferase, blood creatinine, and urea nitrogen levels in patients between the 2 groups before and after use of cefdinir were not statistically significant (all P>0.05). The difference in aspartate aminotransferase before and after use of the cefdinir in the original group was statistically significant [21(18, 23) U/L vs. 23(20, 29) U/L, P=0.040], and the differences in alanine aminotransferase, blood creatinine, and urea nitrogen levels were not statistically significant (all P>0.05). The detection values of liver and kidney function in the 2 groups before and after use of the cefdinir were within the reference range. Conclusion No significant differences were found in the clinical efficacy and safety between the VBP cefdinir dispersible tablets and the original cefdinir capsules.
  • Niu Xiaoqiang
    Adverse Drug Reactions Journal. 2021, 23(6): 326-327. https://doi.org/10.3760/cma.j.cn114015-20201202-01202
    A 41-year-old female patient received Rupixiao capsules 1.6 g thrice daily for hyperplasia of mammary glands. About 30 days later, the patient developed nausea, dark urine, and yellowish skin and sclera. After 20 days of continued treatment, her symptoms worsened, so she stopped using Rupixiao capsules by herself. After 10 days of drug withdrawal, her symptoms were not improved. The laboratory tests showed alanine aminotransferase (ALT) 1-234-U/L, aspartate aminotransferase (AST) 778-U/L, gamma-glutamyltransferase (γ-GT) 174-U/L, alkaline phosphatase (ALP) 156-U/L, total bilirubin (TBil) 78.7-μmol/L, and total bile acid (TBA) 45.4-μmol/L. After excluding liver injury caused by other reasons through laboratory and auxiliary examination, drug-induced liver injury was diagnosed, which was considered to be related to Rupixiao capsules. Drugs such as reduced glutathione, polyene phosphatidylcholine, compound glycyrrhizin, ademetionine 1,4-butanedisulfonate, and bicyclol were given. The patient′s symptoms of nausea, yellow urine, and jaundice gradually subsided. After 35 days of treatments, laboratory tests showed ALT 39-U/L, AST 43-U/L, γ-GT 57-U/L, ALP 85-U/L, TBil 17.3-μmol/L, and TBA 14.3-μmol/L.
  • Wang Dongxue, Cui Yingchun, Xu Feng
    Adverse Drug Reactions Journal. 2021, 23(10): 542-543. https://doi.org/10.3760/cma.j.cn114015-20201209-01224
    A 47-year-old male patient received irbesartan 225-mg orally once daily due to nephrotic syndrome. Three days later, the dose was changed to 300-mg once daily according to the doctor′s advice. His hemoglobin (Hb) was 153-g/L before irbesartan treatment. After 6 days of medication, the patient developed fatigue and weakness. Laboratory test showed that his Hb was 89-g/L. No laboratory test abnormality was found in serum creatinine, stool routine, and bone marrow puncture. After 13 days of medication, his Hb was 87-g/L. Moderate anemia related to irbesartan was diagnosed. Irbesartan was discontinued and IV infusion of methylprednisolone sodium succinate for injection 60-mg once daily and subcutaneous injection of erythropoietin 3-000 U thrice a week were given. Seven days later, the symptoms of fatigue and weakness were improved and laboratory test showed Hb 102-g/L. Twenty-seven days later, his Hb returned to 131-g/L.
  • 中毒救治
    . 2006, 8(5): 368-369.
    秋水仙碱为抗痛风药,可有效控制关节局部的红肿热痛等炎症反应。但其治疗剂量与中毒剂量接近,在体内可被代谢为具有极强毒性的二秋水仙碱,对消化道有刺激作用,可抑制骨髓造血功能,并对神经、平滑肌有麻痹作用,甚至可引起呼吸中枢麻痹而死亡。故不宜长期或大剂量应用。出现严重不良反应须立即停药,并对症救治。
  • Wei Tiantian, Liu Zhen, Wang Zhongkui, Peng Jing, Zhang Jing
    Adverse Drug Reactions Journal. 2021, 23(12): 649-650. https://doi.org/10.3760/cma.j.cn114015-20210120-00086
    A 68-year-old male patient with advanced lung squamous cell carcinoma received intravenous infusion of pembrolizumab 200-mg once every 3 weeks. One week after the 4th IV infusion of pembrolizumab, the patient developed nausea and vomiting. Laboratory tests showed blood potassium 7.39-mmol/L, fasting blood glucose 28.1-mmol/L, β-hydroxybutyric acid 3.23-mmol/L, arterial blood pH 7.16, and bicarbonate 7.5-mmol/L. The patient was diagnosed as diabetic ketoacidosis, which was considered to be associated with pembrolizumab. After 8 days of treatments such as lowering blood sugar and correcting electrolyte disorder, his nausea and vomiting disappeared. Laboratory tests showed blood potassium 3.65-mmol/L, fasting blood glucose 7.5-mmol/L, β-hydroxybutyric acid 0.38-mmol/L, and bicarbonate 25.2-mmol/L.
  • Wang Yue, Zhu Chen, Zhang Chengliang
    Adverse Drug Reactions Journal. 2020, 22(9): 522-526. https://doi.org/10.3760/cma.j.cn114015-20191009-00805
    Oxaliplatin (OXA) is the third‑generation platinum antineoplastic agents, mainly used in the treatment of metastatic colorectal cancer. Sinusoidal obstruction syndrome (SOS) is a common and serious adverse reaction of OXA. The main clinical manifestations are splenomegaly, thrombocytopenia, abnormal liver function, and portal hypertension. The mechanism is closely related to OXA‑induced oxidative stress and inflammatory reactionsin the liver, which lead to injury of hepatic sinusoidal endothelial cells, and then lead to platelet aggregation and vascular obstruction in hepatic sinusoids. The occurrence of SOS is related to the accumulated dose and the treatment cycle of OXA. Splenomegaly is an independent predictor of OXA‑related SOS. Thrombocytopenia, elevated serum hyaluronic acid and aspartate aminotrans- ferase‑to‑platelet ratio index can also predict the occurrence of SOS. OXA should be used with caution in patients with chronic liver disease, especially in those with portal hypertension. Special attention should be paid to the occurrence of SOS during OXA treatment. For patients with symptoms of suspicious SOS, imaging examination should be performed in time. Early diagnosis and timely withdrawal of drugs are bene- ficial for the reversal of liver fibrosis, and the prognosis of patients with severe fibrosis is poor.
  • Zhang Pei, Lao Jiahui, Chen Zhaoyang, Chen Shixian, Li Xiao, Huang Xin
    Adverse Drug Reactions Journal. 2024, 26(7): 405-411. https://doi.org/10.3760/cma.j.cn114015‑20231220‑00920
    Objective To analyze the influencing factors on the occurrence of acute kidney injury(AKI) in hospitalized patients treated with esomeprazole and to construct a risk prediction model to predictthe occurrence of esomeprazole‑associated AKI. Methods The study was designed as a retrospectivestudy. The subjects were selected from patients who were hospitalized in the First Affiliated Hospital of·405·药物不良反应杂志 2024 年7月第 26 卷第7期 ADRJ,July 2024, Vol. 26, No. 7Shandong First Medical University from January 2018 to December 2020 and received treatment withesomeprazole. The clinical data of patients, including basic information, operations, intervention measures,medication, and laboratory test results, was collected through the hospital′s electronic medical recordsystem. Patients were divided into AKI and non‑AKI groups according to the occurrence of esomeprazole‑associated AKI, and the clinical characteristics between the 2 groups were compared. The least absoluteshrinkage and selection operator (LASSO regression) was used to analyze the influencing factors ofesomeprazole‑associated AKI. Patients were randomly divided into the training set and the test set at a 8∶2ratio. Based on data in the training set, 5 machine learning algorithms were used to build esomeprazole‑asso‑ciated AKI prediction models, including logistic regression, random forest, gradient boosting machine(GBM), extreme gradient boosting, and light gradient boosting machine. Based on data in the test set, the per‑formance of 5 models was validated through the area under the receiver operating characteristic curve (AUC),sensitivity, specificity, and accuracy. Results A total of 5 436 patients were enrolled in the study, including 3 231 males and 2 205 females, with an age of 61(51, 70) years. Esomeprazole‑associated AKI occurredin 393 patients, with an incidence of 7.23%. The results of LASSO regression analysis identified 24 variablesclosely related to esomeprazole‑associated, such as hepatic insufficiency, chronic renal insufficiency, hypo‑proteinemia. Based on data in the training set (4 349 patients), the esomeprazole‑associated AKI risk predic‑tion models were constructed and their predictive performance was good (all AUC>0.900). The predictiveperformance validation was conducted using the data in the test set (1 087 patients), and the results showedthat the GBM model has the highest AUC (0.922) and relatively stable performance, with small differences invarious indicators between the training and the test sets. Conclusions The use of esomeprazole is signifi‑cantly associated with AKI, and the risk is influenced by factors such as baseline renal function, comorbidi‑ties, and combined medications. The risk prediction model based on GBM algorithm is helpful for earlyassessment of the risk of esomeprazole‑related AKI in clinical practice.
  • 安全用药
    . 2006, 8(5): 363-367.
    静脉输液是最常用的药物治疗方法,但易发生不同程度的静脉炎。输液静脉炎诱发因素主要有输液的pH值及可滴定酸度、输液的渗透压、药物的化学毒性、机械性刺激等。本文对静脉炎的诱发因素及其防治进行概述,旨在对各诱发因素采取相应的预防措施,尽量减少静脉炎的发生。
  • 滥用误用
    Tang Jing①②;Wang Yuqin①
    . 2007, 9(6): 404-409.
    Vincristine is an antineoplastic agent for intravenous use only;inadvertent intrathecal administration of vincristine may cause severe neurologic damage,and often is fatal.The first fatal case of inadvertent intrathecal vincristine administration was reported by Schacht et al.in 1968.Since then,at least 20 deaths from inadvertent vincristine intrathecal administration are known to have occurred in the United States,Canada,the United Kingdom,Germany,Saudi Arabia,Singapore,Korea,and China.In published case reports,the patients developed rapid sensory and motor dysfunction followed by encephalopathy,coma,and death after inadvertent intvathecal administration of Vincristine.Early signs and symptoms were tremors,disorientation,nausea,and vomiting.The patients became unresponsive within one week.Ascending paralysis occurred in some patients.The time to death ranged from 7 to 83 days.If vincrrstine is mistakenly given by the intrathecal route,the following treatment should be initiated immedi…更多ately:removal of spinal fluid,flushing with sodium lactated Ringer' s injection and fresh frozen plasma diluted in sodium lactated Ringer' s injectiom,administration of glutamic acid,folic acid,vitamin B6 and so on.Reasons for inadvertent intrathecal vincristine administration can be the end-results of either a sigle medication error or a series of medication errors.Suggestions for preventing inadvertent intrathecal vincristine administration include vincristine should be labelled warning label on the syringe and outer wrap,stating "for intravenous use only—fatal if given intrathecally",vincristine should be prepared in a minibag for intraveous infusion rather than a syringe,the storage and delivery of vincristine should be separated from all medicines intended for intrathecal administration,and only specifically trained and designated oncology staff should prepare and administer vincristine.
  • Mao Lu, Lin Ping, Zhang Wei, Liu Fang
    Adverse Drug Reactions Journal. 2021, 23(11): 564-569. https://doi.org/10.3760/cma.j.cn114015-20210412-00442
    Objective To explore the causes of medical disputes related to drug-induced liver injury (DILI). Methods The Excel data sheet of drug-related medical disputes provided by the Beijing Municipal People′s Mediation Committee for Medical Disputes were searched and data on solved cases of DILI-related medical disputes from 2013 to 2019 were collected. The distribution characteristics, related drugs, and causes of disputes in these cases were analyzed retrospectively. Results A total of 30 cases of DILI-related medical disputes were entered. Among the 30 patients, 23 (76.7%) were female and 7 (23.3%) were male, the age ranged from 3 months to 66 years, and the median age was 37 years; 25 (83.3%) were outpatients and 5 (16.7%) were inpatients. The drugs causing liver injury were traditional Chinese medicine (decoction and/or Chinese patent drugs) in 20 patients (66.7%), western medicine in 6 patients (20.0%), traditional Chinese medicine combined with western medicine in 4 patients (13.3%). Among the hospitals involved, tertiary hospitals accounted for 80.0% (24/30) and specialized hospitals of traditional Chinese medicine accounted for 60.0% (18/30). Of the 30 cases, 19 (63.3%) were judged to be the responsibility of the hospitals and the causes of liver injury were medication defects/errors, in which 17 cases (89.5%) were the responsibility of doctors and 2 cases (10.5%) were of nurses. The main problems were lack of inquiry before medication, lack of monitoring during treatment, illegal prescription, and overdosage due to negligence. Conclusion DILI-related medical disputes often occur in outpatient department, most of the drugs involved were traditional Chinese medicine, which may be related to the lack of understanding of hepatotoxi- city of traditional Chinese medicine in physicians (especially physicians in specialized hospitals of traditional Chinese medicine) and the neglect of management for Chinese medicine prescriptions.
  • 安全用药
    . 2003, 5(3): 166-171.
    本文综述了有关甘草酸类药物引起不良反应的报道,其不良反应主要是对内分泌系统的影响:如水、钠潴留,低钾血症,高血压,假性醛固酮增多症等。过敏反应较少,罕见的不良反应有胆汁性肝硬化、上消化道或牙龈出血、腹泻和精神症状。甘草酸类药物不良反应发生的主要机制与该药的肾上腺皮质激素样作用有关。α异构体甘草酸类药物甘利欣的安全性优于β异构体甘草酸类药物。
  • 安全合理用药
    Xie Gang;Li Yunjing*
    . 2007, 9(5): 335-338.
    Hepatic injury may induced by long-term use of total parenteral nutrition.The clinical presentations were elevated values of liver enzyme and bilirubin,cholestasis,fatty degeneration,and cirrhosis.The exact mechanism of TPN-induced hepatic injury is presently unknown;it may associated with the long-term fasting,imbalance of administered nutrients,and intestinal bacterial translocation.Balance of administered nutrients,use of cyclic infusion,early enteral feeding,and supplementation of some nutrients(such as choline and L-glutamine)may be beneficial to prevention and treatment of TPN-induced hepatic injury
  • 滥用误用
    Zhang Kaigao
    . 2010, 12(3): 194-3.
    Methamphetamine(MA), commonly called as ice, is a stimulant of the family of phenethylamines, which is one of widely abused illicit drugs in the world. Methamphetamine increases the release and blocks the reuptake of the monoamine neurontransmitter, such as dopamine, norepinephrine, and serotonin, leading to high level of the chemicals in the synaptic cleft and inducing psychological and physical effects. Methamphetamine users may develop euphoria, increased physical activity and hypersexuality. Sudden withdrawal of methamphetamine in methamphetaminedependent subjects may result in abstinence reactions including sleep disturbance, depressed mood, anxiety, agnosia, and decreased physical activity. A methamphetamine abstinence reaction can be categoried into two phases: the acute phase (lasting 7~10 days), and the subacute phase (lasting a further 2 weeks). The relapse rates to the methamphetaminedependent subjects is rather high. Preventing the occurrence of relapse is of very important practical siginifance.
  • Zhao Xue, Li Fan, Zhang Yanli, Zhang Xiao, Cao Junling
    Adverse Drug Reactions Journal. 2022, 24(3): 147-149. https://doi.org/10.3760/cma.j.cn114015-20210401-00399
    A 41-year-old female patient received long-term treatment with metformin, glimepiride, sitagliptin, and acarbose for type 2 diabetes mellitus. Due to elevated blood-glucose, the hypoglycemic regimen was adjusted to metformin, acarbose, and dulaglutide (1.5-mg, subcutaneously injected once a week). After each injection of dulaglutide, the patient had severe anorexia but no intervention was given because that the patient could tolerate. Empagliflozin 10-mg orally once daily were added 3 days after the first injection and then the dose was adjusted to 10-mg next day. The day after the fourth injection, the patient developed dizziness, nausea, vomiting, general fatigue, etc. Laboratory tests showed blood glucose 20-mmol/L, arterial blood pH 7.22, partial pressure of carbon dioxide 22.1-mmHg, bicarbonate concentration 8.8-mmol/L, standard bicarbonate 12-mmol/L, total carbon dioxide content 10-mmol/L, ketone body in urine (+++), and urine sugar (++++). Diabetic ketoacidosis was diagnosed. Considering that severe anorexia after the application of dulaglutide caused serious insufficient carbohydrate intake and then empagliflozin- induced diabetic ketoacidosis was stimulated, the 2 drugs were discontinued and symptomatic and supportive treatments were given. Five days later, laboratory tests showed post-lunch blood glucose 10.1-mmol/L, ketone body in urine (+), negative urine sugar, and urine pH 5.5. Empagliflozin 5-mg once daily was added and laboratory tests showed carbon dioxide binding capacity of the blood 23.2-mmol/L, urine ketones (+++), urine sugar (++++), and uric acidity 5.0 four days later. The patient insisted on leaving the hospital. After discharge, she was treated with recombinant insulin glargine, acarbose, and empagliflozin. At 1 month of follow-up, symptoms of diabetic ketoacidosis did not recur.
  • Xu Lu
    Adverse Drug Reactions Journal. 2021, 23(11): 603-604. https://doi.org/10.3760/cma.j.cn114015 20210106 00020
    A 46 year old female patient with primary biliary cholangitis received Lanqin oral solution (蓝芩口服液) 10 ml orally thrice daily because of pharyngeal pain due to cold. About 20 minutes after taking the first dose of the drug, the patient suddenly felt general discomfort and numbness of mouth and tongue, followed by vomiting, sweating, pale complexion, dyspnea (27 times per minute), and hypotension (104/56 mmHg). Anaphylaxis induced by Lanqin oral solution was considered, the drug was discontinued and the liquid supplement to expand the blood volume and chlorphenamine maleate for anti allergy were given. One hour later, the patient′s symptoms disappeared and the blood pressure returned to 124/76 mmHg. The next day, the patient did not follow the doctor′s advice and took Lanqin oral liquid 10 ml again by herself. A few minutes later, she developed nausea and abdominal pain. The fluid infusion and symptomatic treatment were given immediately, and the symptoms disappeared 20 minutes later.
  • Sun Yue, Liu Jia, Liao Qingchi
    Adverse Drug Reactions Journal. 2020, 22(4): 266-267. https://doi.org/10.3760/cma.j.cn114015-20200103-00005
    A 72-year-old female patient received intravenous injection of furosemide injection and oral metoprolol succinate sustained-release tablets, furosemide tablets, spironolactone tablets, digoxin tablets, and isosorbide mononitrate sustained release tablets for heart failure. Continuous intravenous pumping of levosimendan 12.5-mg dissolved in 0.9% sodium chloride 45-ml at a speed of 1.5-ml/h was additionally given because of her unimproved symptoms of heart failure. After 20-hours of intravenous pumping, the patient developed unconsciousness, no response to voice stimuli, and bilateral mydriasis suddenly. The electrocardiogram monitoring showed heart rate 200 beats per minute, prolonged QT interval, and QTc period 520-ms. The laboratory tests showed serum potassium 3.02-mmol/L. She was diagnosis as Torsades de Pointes and Aspen syndrome, which were considered to be related with levosimendan. Levosimendan was stopped immediately. The treatments such as closed-chest cardiac massage, electric defibrillation, and potassium supplementation were given. Four days later, the reexamining results showed her serum potassium 4.60 mmol/L, heart rate 80 beats per minute, and QTc period 450-ms.
  • Bai Xiangrong, Wang Yangai, Chen Bing
    Adverse Drug Reactions Journal. 2023, 25(12): 712-716. https://doi.org/10.3760/cma.j.cn114015-20230403-00249
    Objective To mine the risk signals of baloxavir marboxil-related adverse events (AEs) and provide reference for rational use in clinical practice. Methods The report odds ratio (ROR) and proportional reporting ratio (PRR) methods were used to mine the risk signals of baloxavir marboxil-related AEs in the US Food and Drug Administration Adverse Event Reporting System (FAERS) from the 1st quarter of 2018 to the 4th quarter of 2022. The AE with reports ≥3 and 95% confidence interval (CI) lower limit of ROR or PRR>1 was defined as a risk signal. AEs were classified according to the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities (MedDRA) 25.1 for statistical analysis. Results A total of 1-102 AE reports were retrieved, involving 1-102 patients, and 498 were serious AE. A total of 45 AE risk signals were obtained by ROR and PRR methods. The top 10 PTs in signal intensity were febrile seizures, ischemic colitis, bacterial pneumonitis, anaphylaxis, hemorrhagic cystitis, erythema multiforme, melena, anaphylactic shock, disseminated intravascular coagulation, and anaphylactic reaction. Of them, 26 PTs were not recorded in the labels, in which the top 10 PTs were febrile seizures, ischemic colitis, bacterial pneumonia, hemorrhagic cystitis, disseminated intravascular coagulation, altered mental status, fever, rhabdomyolysis, cyanosis, and facial paralysis. The top 5 SOCs that involved more PTs were nervous system disorders, gastrointestinal disorders, respiratory system diseases, psychiatric disorders, and blood and lymphatic system disorders. Among the 498-serious AEs, a total of 5 risk signals were mined, including infectious pneumonia, diarrhea, rhabdomyolysis, allergic reactions, and abnormal behavior. Conclusion The attention should be paid to AEs not mentioned in the drug label in clinical application of baloxavir marboxil, such as febrile seizures, bacterial pneumonia, ischemic colitis, and hemorrhagic cystitis.
  • Zhang Hongmei, Tian Xu, He Yangfang, Zhou Wei
    Adverse Drug Reactions Journal. 2020, 22(12): 705-706. https://doi.org/10.3760/cma.j.cn114015-20200320-00300
     A 35-year-old female patient received metronidazole sustained release tablets 0.75 g once daily and cefuroxime axetil 0.25 g twice daily after hysteroscopy curettage for infection. Because of postoperative fever and cough, she took ibuprofen granules 0.2 g each time orally by herself. After 3 days of treatments with metronidazole sustained release tablets and cefuroxime axetil and 4 times of ibuprofen granules, the patient developed right upper abdominal pain and dark urine. On the next day, the patient′s right upper abdominal pain was aggravated progressively, she developed soy sauce-like urine and yellowish skin and sclera. Laboratory tests showed alanine aminotransferase (ALT) 403-U/L, aspartate aminotransferase (AST) 248-U/L, gamma glutamyl transpeptidase (γ-GT) 327-U/L, alkaline phosphatase (ALP) 58-U/L, total bilirubin (TBil) 72.5-μmol/L, and direct bilirubin (DBil) 41.5-μmol/L. Liver injury induced by concomitant use of metronidazole and ibuprofen was considered. Metronidazole and ibuprofen were stopped and liver-protective and symptomatic treatments were given. Cefuroxime axetil was continued. Three days later, the patient′s abdominal pain disappeared gradually, her urine color became lighter, the yellow staining of skin and sclera was alleviated, and the respiratory symptoms were improved. Nine days later, the reexamination of liver function showed ALT 88-U/L, AST 35-U/L, γ-GT 185-U/L, ALP 52-U/L, TBil 19.6-μmol/L, and DBil 9.7-μmol/L.
  • Zhang Yalan, Hong Wencong, Chen Qiying
    Adverse Drug Reactions Journal. 2023, 25(11): 656-661. https://doi.org/10.3760/cma.j.cn114015-20230410-00261
    Objective To mine the risk signals of ipilimumab-related adverse events (AEs) and provide reference for the safe use in clinical practice. Methods AE reports with ipilimumab as the primary suspect drug were collected from US FDA Adverse Event Reporting System database during March 1, 2011 to September 30, 2022. AEs were standardized and classified according to the preferred term (PT) and system organ class (SOC) in Medical Dictionary for Regulatory Activites version 26.0. The AE risk signals of ipilimumab were mined using reporting odds ratio (ROR) method. An AE with reports≥3, ROR≥2, 95% confidence interval (CI) lower limit of ROR>1 was defined as a risk signal. Risk signals were analyzed using descriptive method. Results A total of 12-329 AE reports were entered in the analysis, involving 1-915 PTs. Two hundred and sixty-eight risk signals (PTs) were obtained using ROR method, involving 21 SOCs. The top 10 PTs in report number were diarrhea, colitis, rash, fever, hypophysitis, adrenal insufficiency, decreased appetite, hypothyroidism, liver disease, and dehydration, all of which were common AEs in the labels. The top 10 PTs in signal intensity were hypophysitis, lymphocytic hypophysitis, immune-mediated dermatitis, immune-mediated adrenal insufficiency, hypopituitarism, immune-mediated liver disease, adrenocorticotropic hormone deficiency, immune-mediated encephalitis, autoimmune colitis, and immune-mediated hyperthyroidism. The SOCs involved were endocrine system diseases, skin and subcutaneous tissue diseases, hepatobiliary system diseases, gastrointestinal system diseases, and nervous system diseases. A total of 36 PTs were not included in the labels, and the top 5 in signal intensity were intracranial tumor hemorrhage, radiation necrosis, malignant pleural effusion, pulmonary granuloma, and lichenoid keratosis. Conclusions The main AEs of ipilimumab are diarrhea, colitis, rash, etc. In addition, ipilimumab might cause adverse reactions such as intracranial tumor hemorrhage, radiation necrosis, and malignant pleural effusion that are not recorded in label, which should be vigilant in clinical practice.
  • 监测简报
    . 2004, 6(1): 50-52.
  • Gao Tingting, Tai Shibin
    Adverse Drug Reactions Journal. 2022, 24(2): 106-107. https://doi.org/10.3760/cma.j.cn114015-20210601-00623
    A 53-year-old male patient received subcutaneous injection of insulin aspart 30 injection 12 units twice daily and acarbose 50-mg orally thrice daily for 13 months because of type 2 diabetes mellitus, but the patient had poor glucose control. Oral glucose tolerance test showed that the fasting, 1-hour, 2-hour, and 3-hour postprandial blood glucose were 8.84, 17.94, 21.22, and 18.51-mmol/L respectively, insulin was 109.5 mU/L, C-peptide was 0.52-nmol/L, and insulin autoantibody was >175-U/ml. Exogenous insulin antibody syndrome was considered. Insulin aspart 30 injection was discontinued and replaced by metformin, pioglitazone, acarbose, and glimepiride orally. Thirteen days later, the patient′s fasting blood glucose decreased to 7.6-mmol/L. At 1 year of follow-up, the patient′s insulin autoantibody were negative in 3 tests. It is considered that the exogenous insulin antibody syndrome in the patient was caused by insulin aspart 30 injection.
  • Duan Rong, Tang Bixia, Li Siming, Yan Xieqiao, Sheng Xinan, Cui Chuanliang,
    Adverse Drug Reactions Journal. 2020, 22(10): 553-558. https://doi.org/10.3760/cma.j.cn114015-20200208-00089
    Objective To explore the occurrence and clinical characteristics of hyperprogression of metastatic malignant melanoma caused by toripalimab (JS001). Methods The medical records of patients with metastatic malignant melanoma treated with JS001 alone or in combination with other antineoplastic agents between February 2018 and September 2019 in Department of Kidney Cancer and Melanoma of Beijng Cancer Hospital were collected. Patients displaying hyperprogression were screened into the case group, who were matched with those without hyperprogression evidence (the control group) in a 1/4 ratio according to baseline age, gender, Eastern Cooperative Oncology Group score, location of the primary lesion, and elevated level of lactate dehydrogenase (LDH). The clinical characteristics and prognosis of patients between the 2 groups were compared and the hyperprogression in the case group was analyzed descriptively. Results A total of 130 patients with metastatic malignant melanoma who received JS001 alone or in combination with other antineoplastic agents were collected. Hyperprogression occurred in 8 patients (the case group), including 5 males and 3 females, aged (52.5±8.5) years. The incidence of hyperprogression was 6.15%. Thirty-two patients without displaying hyperprogression were matched as the control group according to the baseline characteristics of patients in the case group. Patients with metastatic lesions in more than 2 organs at baseline in the case group were significantly more than those in the control group (6/8 vs. 7/32, P=0.014); the LDH level of patients in the case group significantly increased after treatment than before [(965±710) U/L vs. (264±64) U/L, P=0.025]; the progression-free survival and overall survival in patients were significantly lower than those of patients in the control group [1.7 (95%CI: 1.4-2.0) months vs. 3.1 (95%CI: 2.7-3.5) months, P<0.001; 4.8 (95%CI: 0-11.2) months vs. 10.7 (95%CI: 10.4-10.9) months, P=0.031]. Conclusions Patients with melanoma may experience hyperprogression in early stages of JS001 treatment. Patients with metastatic lesions in more than 2 organs before treatment are more likely to develop hyperprogression, and patients displaying hyperprogression have a poor prognosis. Serum LDH level monitoring can help detect tumor hyperprogression as early as possible.
  • Cai Jun, Chen Jie, Gao Lei, Hu Yun,Li Man
    Adverse Drug Reactions Journal. 2022, 24(12): 633-640. https://doi.org/10.3760/cma.j.cn114015-20220328-00250
    Objective To explore the clinical characteristics of syndrome of inappropriate antidiu- retic hormone secretion (SIADH) induced by duloxetine. Methods The diagnosis and treatment of a patient with duloxetine-related SIADH who was admitted to Nanjing Drum Tower Hospital Affiliated to Medical College of Nanjing University was reported, and the main clinical data (gender, age, prevalent diseases, use of duloxetine, combined medication, occurrence of SIADH, and intervention and outcome) of the case and related cases collected from the PubMed and Embase databases (up to December 31, 2021) were analyzed by descriptive statistics. Results A total of 27 patients were included in the analysis, including 6 males and 21 females, aged from 38 to 92 years with a median age of 74 years. duloxetine with daily dose of 20, 30, 40, 60-mg and unknown dose were in 5, 9, 1, 10 and 2 patients, respectively, and one patient with daily dose of 30-mg developed SIADH after a single overdose of 450-mg. Sixteen patients were treated with drugs that may cause hyponatremia or interact with duloxetine. Among them, 6, 2, 6, and 2 patients were treated with 1, 2, 3, and 4 drugs, respectively. The time from the beginning of duloxetine administration to the occurrence of SIADH, was 2 days to 36 months in 26 patients, with a median time of 3 days, except that one patient of overdose was 1 hour after administration, among which 21 patients occurred within 7 days. The main clinical manifestations of SIADH included nervous system symptoms (headache, dizziness, drowsiness, etc. in 20 patients), digestive system symptoms (nausea, vomiting, anorexia, etc. in 15 patients), and systemic symptoms (fatigue, limb weakness, etc. in 6 patients). When SIADH was diagnosed, the serum sodium level of the 27 patients was 98 to 132-mmol/L, with a median level of 117-mmol/L. The severity of SIADH with grade 1, 3, and 4 was in 1 (3.7%), 7 (25.9%), and 19 (70.4%) patients, respectively. After the diagnosis or suspicion of duloxetine-related SIADH, duloxetine was discontinued in all patients, fluid intake was restricted and sodium supplement was administered. Furosemide was given in 5 patients, and the serum sodium levels returned to normal within 2 to 15 days, with a median recovery time of 5 days. Conclusions Duloxetine- related SIADH mostly occurs within 7 days after the start of medication, and the degree is more serious. After stopping duloxetine, restricting the fluid intake, giving sodium supplement, and giving diuretics depending on the condition, the patient has a good prognosis.
  • Cai Haodong
    Adverse Drug Reactions Journal. 2020, 22(2): 95-102. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.007
    Three antiviral drugs, including interferon α (aerosol inhalation), lopinavir/ritonavir (oral medication), and ribavirin (intravenous infusion), are recommended by Diagnosis and Treatment of Novel Coronavirus Pneumonia (revised version, the 5th ed), which was issued by the National Health Commission of People′s Republic of China and National Administration of traditional Chinese Medicine. In addition, clinical trials on a new antiviral drug ---remdesivir which is not yet on the market has also been launched in China. Medication safety related data on treatment for infections of severe acute respiratory syndrome coronavirus, middle respiratory syndrome coronavirus, human immunodeficiency virus, lopinavir/ritonavir, and ribavirin, safety data of remdesivir in animal experiment, phase I clinical trials and clinical trials of treating Ebola virus infection, and preliminary reports of treatment in novel coronavirus pneumonia were briefly reviewed, aiming to provide evidence for clinical safety medication.
  • Liu Miaomiao, Sun Shuchen, Wang Fan
    Adverse Drug Reactions Journal. 2021, 23(3): 148-149. https://doi.org/10.3760/cma.j.cn114015-20200412-00401
    A 6-year-old girl received sinupret oral drops and mometasone furoate aqueous nasal spray for allergic rhinitis for more than 1 month, but her symptoms were not improved. Additional use of oral montelukast sodium chewable tablets 4-mg every night was given due to adenoid hypertrophy. After 7 days of montelukast sodium administration, the girl developed somnambulism once per week, which manifested as sitting up suddenly in the dream and lying down to sleep after 1-minute. Two months later, all drugs were stopped because the nasal symptoms were relieved and no sleepwalking occurred 1 week after drug withdrawal. More than a year later, the above 3 drugs were given by her parents due to the recurrence of rhinitis and the girl developed somnambulism again with worse symptoms 5 days later. After 2 weeks of continued medication, somnambulism continued to worsen. Montelukast sodium was stopped, symptoms of somnambulism were relieved 2 days later and disappeared 1 month later. Considering that somnambulism in the girl was an adverse reaction to montelukast sodium, it was replaced by oral loratadine 5-mg every night. At 3 months of telephone follow-up, the somnambulism did not occur in the girl.
  • Jiang Yongxian, Ye Xi, Li Aiyan, Qin Bo, Chen Wenwen, Lang Bingchen, Li Gen
    Adverse Drug Reactions Journal. 2023, 25(9): 538-542. https://doi.org/10.3760/cma.j.cn114015-20230116-00018
    Objective To explore the clinical characteristics of anaphylaxis caused by gonado- relin in children in gonadotropin-releasing hormone (GnRH) stimulation test. Methods The research subjects were children aged ≤14 years who experienced anaphylaxis using gonadorelin in the Chengdu Adverse Reaction Center database from January 1, 2015 to December 31, 2021. The purpose of medication was GnRH stimulation test. Through the hospital information system, the children′s basic information, usage of gonadorelin, occurrence of severe allergic reactions, and treatments and outcomes of anaphylaxis were collected and retrospectively analyzed. Results A total of 14 cases of anaphylaxis in children caused by gonadorelin in the GnRH stimulation test were collected, including 3 males and 14 females, with an age of (9±2) years. All 14 cases were evaluated with a score of ≥5 using the Naranjo evaluation method. The dose of gonadorelin in the 14 children was (2.55±0.09) μg/kg and the drug was all given by intravenously injection; anaphylaxis occurred in 4 children during the first GnRH stimulation test and in 10 children during the second GnRH stimulation test. The time from medication to anaphylaxis occurence was (6.0±3.5) minutes. The symptoms of anaphylaxis in 14 children were systemic allergic reactions, involving various systems throughout the body. All children had 3 or more types of systemic damage. After anaphylaxis occurrence, gonadorelin was discontinued in all 14 patients; 5 received intramuscular injection of adrenaline, 5 received intravenous injection of adrenaline, 1 received intravenous injection of isoprenaline and intramuscular injection of adrenaline, and 3 received intravenous injection of dexamethasone only. After treatments, all children were improved. Conclusions Anaphylaxis caused by gonadorelin in children is a rare but severe adverse reaction, and the drug may have a possibility of cross allergy with GnRH analogues. Therefore, when diagnosing and treating precocious puberty in children, medication should be given under monitoring conditions.
  • Bi Yunyan, Gao Ping, Guo Nan, Yuan Shan, Zhang Wen
    Adverse Drug Reactions Journal. 2023, 25(1): 47-52. https://doi.org/10.3760/cma.j.cn114015-20220824-00776
    With the application of immune checkpoint inhibitors (ICIs), the acute kidney injury (AKI) caused by ICIs has attracted increasingly extensive attention. The incidence of ICIs-induced AKI is 0.8%-29%, which can occur weeks or months after the first drug use or even after drug withdrawal. The typical renal histopathological features of AKI are acute tubulointerstitial nephritis, and glomerulopathy can also be seen. The risk factors include combined application of ICIs, the use of proton pump inhibitors, and having chronic kidney diseases, etc. After the diagnosis of AKI, it is necessary to decide whether to reduce the dose or stop using ICIs and start glucocorticoid treatment or add other immunosuppressive drugs accor- ding to the degree of disease and the specific situation of the patient. In case of level 3-4 AKI, ICIs shall be permanently discontinued.
  • Xing Man, Shi Shiqiang, Gao Jing, Wang Na
    Adverse Drug Reactions Journal. 2020, 22(4): 270-271. https://doi.org/10.3760/cma.j.cn114015-20181216-01249
    A 61-year-old female patient underwent intestinal preparation before electronic colonoscopy. She took polyethylene glycol electrolytes powder (Ⅳ) in 6 times (dissolved content A 24 bags and B 24 bags in warm water 3-000-ml and then took 500-ml orally per 30-minutes). During the intestinal preparation, the patient′s urine output was about 4-500-ml, diarrhea occurred 8 times, and she vomited 2 times within 5.5-hours. The patient fell into a coma at 14:00 on the day, accompanied by limb convulsion and trismus. Laboratory tests showed that the serum sodium and potassium decreased from 140-mmol/L and 4.0-mmol/L to 120-mmol/L and 2.7-mmol/L before and after treatment, respectively. In addition, his chloride was 87.2-mmol/L and bicarbonate was 11.5-mmol/L. Blood gas analysis showed pH 7.29-mmHg, partial pressure of carbon dioxide 31-mmHg, partial pressure of oxygen 105-mmHg, and base excess -10.4-mmol/L. Metabolic acidosis was diagnosed. Head CT and MRI showed no abnormalities. Electrolyte disorder, metabolic acidosis, and hyponatremia encephalopathy due to hyponatremia caused by polyethylene glycol electrolytes powder (Ⅳ) was considered. Oxygen inhalation, continuous ECG monitoring, correction of electrolyte disorders, correction of acidosis, rehydration, and other symptomatic and supportive treatments were given immediately. After 4 hours of treatments, the vital signs of the patient were gradually stable but she was still in a coma. On the third day of treatments, the patient was conscious, her serum electrolytes returned to normal, and no seizures occurred.
  • . 2016, 18(1): 52.
  • Han Maozhi, Li Shasha, Li Jing, Li Xianchao, Gao Linlin, Lu Yan, Zhou Ziyu
    Adverse Drug Reactions Journal. 2020, 22(6): 375-376. https://doi.org/10.3760/cma.j.cn114015-20200309-00240
    A 23-year-old male patient received moxifloxacin, recombinant human interferon α-2b for injection, and lopinavir and ritonavir for 7 days for novel coronavirus pneumonia. There was no abnor-malityof serum potassium. Moxifloxacin was stopped, Qingfei Paidu decoction(清肺排毒汤) was given, and then the patient′s serum potassium began to rise. On day 10 after taking the decoction, laboratory tests showed serum potassium 5.7-mmol/L and the patient was diagnosed with hyperkalemia. Insulin injection 4 U diluted to 5% glucose injection 250-ml was given once by IV infusion, and then the serum potassium decreased to 5.0-mmol/L 6 hours later and 4.6-mmol/L 2 days later. After 5 days, the serum potassium rose again and finally to 5.4-mmol/L on day 17 after taking the decoction. Insulin was given once that day and 2 days later once daily according to the previous method. Then the serum potassium decreased and did not rise again. The patient recovered from novel coronavirus pneumonia and was discharged on day 28 after hospitalization.
  • Hao Liya, Li Zhengchuan, Wang Lihua
    Adverse Drug Reactions Journal. 2020, 22(7): 420-421. https://doi.org/10.3760/cma.j.cn114015-20190201-00107
    A 56-year-old male patient purchased Shiduqing capsules by himself and took the drug orally 1.5 g thrice daily for pruritus and rash. After 7 days of administration, the patient developed yellow urine, abdominal distension, and yellowish skin. Laboratory tests showed alanine aminotransferase (ALT) 1-871-U/L, aspartate aminotransferase (AST) 1-502-U/L, alkaline phosphatase (ALP) 222-U/L, total bilirubin (TBil) 260.6-μmol/L, and direct bilirubin (DBil) 187.7-μmol/L. Viral hepatitis, autoimmune liver disease, and intra and extrahepatic space-occupying lesions were excluded by virological detection of hepatitis, autoantibody examination, and imaging examination. Liver injury caused by Shiduqing capsules was considered. Then Shiduqing capsules were discontinued and magnesium isoglycyrrhizinate injection and Shuganning injection(舒肝宁注射液) were given by intravenous infusion. Twenty-eight days later, the patient′s symptoms were improved significantly, and laboratory tests showed ALT 56-U/L, AST 65-U/L, TBil 68.9-μmol/L, and DBil 51.5-μmol/L. It was considered that the liver injury was related to the component of densefruit pittany root-bark (Cortex Dictamni) in Shiduqing capsules.
  • Lin Zhiqiang, Chen Tingting, Wu Shuifa, Hong Limian
    Adverse Drug Reactions Journal. 2020, 22(10): 573-576. https://doi.org/10.3760/cma.j.cn114015-20200414-00405
    A 56-year-old male patient with tuberculosis complicated by infection did not get better after treatment with moxifloxacin combined with rifampicin, isoniazid, ethambutol, and pyrazinamide. The invasive pulmonary aspergillosis was diagnosed by bronchoalveolar lavage fluid culture and detection of 1,3-beta-D-glucan, galactomannan antigen, and Aspergillus antibody. Moxifloxacin and anti-tuberculosis drugs were discontinued and an IV infusion of voriconazole (the dose was 300-mg once per 12-hours on the first day, the maintenance dose was 150-mg once per 12-hours) was given. On the 5th day of medication, the plasma concentration of voriconazole was zero. The consultation pharmacist considered that the voriconazole plasma concentration was related to rifampicin. The next day, the dose of voriconazole was adjusted to 200-mg once per 12-hours. Two days later, the plasma concentration of voriconazole was 1.3-mg/L. The patient′s cough and expectoration were relieved, but he still repeatedly developed high fever. On the 9th day of increase of voriconazole dose, intravenous infusion of methylprednisolone 40-mg once daily was given because connective tissue disease could not be excluded by consulting rheumatologists. The patient′s temperature returned to normal the next day and the plasma concentration of voriconazole was 3.0-mg/L. Clinical pharmacists and physicians reviewed the literature and reached a consensus: the induction effect of rifampicin on drug metabolizing enzymes in the body can last for 7-10 days or even longer after discontinuation of the drug, the monitoring of plasma concentration of voriconazole should be strengthened in patients treated with rifampicin sequential voriconazole, and the dose of voriconazole should be adjusted according to the plasma concentration until the induction effect of rifampicin on drug metabolizing enzymes completely disappears and the plasma concentration of voriconazole reaches a steady state.
  • 调查研究
    Zhang Qiuxia;Wang Yuling
    . 2004, 6(2): 82-84.
    Object iv e:To investigate kidney damage caused by low-dose of enteric-coated aspirin t ablets.Method:The outcomes of600patients tak ing aspirin(50~75mg dai ly)were retrospectively analysed from January1995to August2003in our h ospital.Results:Kid ney damage occurred in16of600cases.Its frequen cy wa s related to age of patients,dosage and treatment duration of aspirin.And imp aired renal function was returned to normal gradually when aspirin was withdrawn in them.Conclusion:Prolonged oral admi nist ration of aspirin in low-dose can cause kidney damage and ordinary exam ination of urine and renal function is suggested,especially for the elderly.
  • Zhen Jiancun
    Adverse Drug Reactions Journal. 2022, 24(11): 561-563. https://doi.org/10.3760/cma.j.cn114015-20221008-00890
    The prevalence of diabetes mellitus in China is rising year by year. Insulin is one of the important treatment means. However, insulin therapy still faced with the challenges of delayed initiation and intensive treatment, resulting in poor clinical blood glucose control. The potential risks of hypoglycemia, glycemic variability, treatment compliance, and other problems in insulin therapy make difficulties in clinic. Compared with currently used insulin, new insulin analogues have characteristics of longer action time and more stable pharmacokinetic/pharmacokinetic features, and can improve the safety of insulin treatment, glycemic variability, and patients′ treatment willingness and compliance in clinical application, thus provide good treatment options for safe, convenient, and stable control of blood glucose in diabetes patients.
  • 中毒救治
    . 2003, 5(5): 318-320.
    为提高毒鼠强中毒的诊治水平,本文介绍了毒鼠强的毒性、中毒机制、临床表现和救治研究进展,旨在增强人们对毒鼠强中毒的认识,提高抢救成功率,减少死亡和后遗症。
  • 专题讲座
    . 2005, 7(6): 445-449.
  • Zhi Yongjin, Zhou Fenfen, Wen mengjing, Wu Zhengdong, Zhu Jianfeng
    Adverse Drug Reactions Journal. 2020, 22(5): 315-316. https://doi.org/10.3760/cma.j.cn114015-20190102-00007
    A 69-year-old male patient with peripheral T-cell lymphoma received chemotherapy with intravenous doxorubicin liposome. In the first chemotherapy cycle, no obvious adverse reactions appeared. In the second chemotherapy cycle, the patient developed transient muscle soreness during the IV infusion of doxorubicin liposome. In the third chemotherapy cycle, dexamethasone and chlorphenamine were given to prevent anaphylaxis before doxorubicin liposome treatment and the infusion rate was controlled in a standardized way. However, at about 20-minutes of infusion, the patient developed nausea and vomiting. The infusion of doxorubicin was stopped immediately and replaced by IV infusion of 0.9% sodium chloride injection 250-ml. Then the patient developed facial numbness, laryngeal pain, neck discomfort, and multiple parts of skin rash with pruritus. The electrocardiogram monitoring showed heart rate 130 times/min, blood pressure 80/50-mmHg, and oxygen saturation 0.98. The patient was given oxygen inhalation and in half-lying position following the doctor′s advice, but the patient developed dyspnea, hoarseness, and slurred speech 20-minutes later. Physical examination showed the patient′s tongue was hypertrophic, his neck was swollen and thickened. Acute laryngeal edema induced by doxorubicin liposome was considered. Intravenous injection of dexamethasone 10-mg, IV infusion of 10% calcium gluconate, and aerosol inhalation of budesonide inhalation aerosol were given immediately and about 3 hours later, the symptoms gradually improved. Two days later, the allergic symptoms disappeared.
  • 安全合理用药
    Zheng Ce;Mei Dan*
    . 2007, 9(4): 256-261.
    Warfarin is an oral anticoagulant used in the treatment and prophylaxis of thromboembolic disorders.Many factors affect warfarin's anticoagulant effect(enhancement or diminishment).These factors include genetics,diseases,drugs,herbal medicines,food,etc.Several polymorphisms of CYP2C9(mainly CYP2C9*2 and CYP2C9*3),liver function insufficiency,hyperthyroidism,heart failure,and interactions of warfarin with aspirin,clopidogrel,miconazole,angelica,fennel,celery,pineapple,onion,and garlic enhance the anticoagulant effect of warfarin.Gene mutation of VKORC1 and interactions of warfarin with rifampicin,carbamazepine,ginseng,green tea,and plenty vitamin K-containing preparations or diets diminish the anticoagulant effect of warfarin.Further more,some drugs such as phenytoin sodium can increase as well as decrease warfarin's anticoagulant effect.Understanding of these factors affecting the anticoagulant effect of warfarin,regular monitoring of INR,and individualizing medication are beneficial to safe and effective use of warfarin.
  • Wang Shuo, Cai Haodong, Mei Dan
    Adverse Drug Reactions Journal. 2021, 23(7): 370-376. https://doi.org/10.3760/cma.j.cn114015-20210712-00783
    Vaccine development and vaccination are the most effective means to prevent and control coronavirus disease 2019 (COVID-19). At present, there are 4 types of COVID-19 vaccines approved for emergency use by the World Health Organization and approved conditionally for marketing and emergency use by State Drug Administration of China, including inactivated vaccine, recombinant protein subunit vaccine, messenger RNA vaccine, and adenovirus vector-based vaccine. Pre-marketing clinical studies show that the vaccines above-mentioned can effectively stimulate the body′s immune system to produce antibodies against COVID-19, the overall safety is good. Most of the adverse events after vaccination are mild or moderate. However, COVID-19 vaccination involves a large number and wide range of people, and its safety problems can not be ignored. The medical workers and researchers should be on high alert and conduct long-term monitoring to ensure vaccine safety.
  • Wang Jianglin, Zuo Xiaocong, Pang Xiaoyun
    Adverse Drug Reactions Journal. 2020, 22(7): 426-427. https://doi.org/10.3760/cma.j.cn114015-20190313-00251
    A 31-year-old female patient took mesalazine 1 g thrice daily orally for colitis gravis. Her serum creatinine (Scr) was 78-μmol/L before medication. Five months later, her blood urea (BUN) was 8.3-mmol/L, Scr was 185-μmol/L, and estimated glomerular filtration rate (eGFR) was 31-ml/(min·1.73m2).  Pathological examination of renal biopsy showed acute tubulointerstitial nephritis and glomerulosclerosis. Kidney injury related to mesalazine was considered. Then the drug was stopped. After 26 days of mesalazine withdrawal, laboratory tests showed BUN 4.0-mmol/L, Scr 130-μmol/L, and eGFR 47-ml/(min·1.73 m2). Prednisone acetate 30-mg daily was given and the dose was decreased to 15-mg daily 2 months later. Then laboratory tests showed BUN 5.5-mmol/L, Scr 93-μmol/L, and eGFR 71-ml/(min·1.73 m2).
  • Sun Zhenxiao, Yu Xiangfen
    Adverse Drug Reactions Journal. 2021, 23(3): 167-168. https://doi.org/10.3760/cma.j.cn114015-20200416-00424
    A 52-year-old male patient was given escitalopram 5-mg/d (gradually increased to 15-mg/d), trazodone 100-mg/d, and lorazepam 1-mg/d for depression. Increased salivary secretion occurred 3 days after taking the medicine. After 13 days of taking the medicine, she only took escitalopram and lorazepam due to lack of trazodone. After stopping trazodone for 3 days, the symptoms of increased salivary secretion disappeared. Trazodone 100-mg/d was added again later due to poor sleep and increased salivary secretion relapsed after 2 days of trazodone administration. Considering that the above symptoms were related to trazodone, the doctor ordered him to stop the drug and take escitalopram and lorazepam only. Three days later, the patient′s increased salivary secretion disappeared again. The patient′s depressive symptoms were relieved and increased salivary secretion did not recur at a 2-week follow-up.
  • 论著
    Yan Yan;Wang Yuqin;Shen Qian;Liu Chen;Tang Jing
    . 2014, 16(2): 74-5.

    ObjectiveCompare criteria of eight countries such as United States for potentially inappropriate medications (PIM) in elderly, to provide a reference for formulating China′s PIM criteria. MethodsUsing the database and network, the authors collect the PIM criteria in elderly that has been released from the inception to December 2012. Eight countries PIM criteria were selected and their development method, expert panel′s composition and contents were compared.ResultsPIM criteria from a total of eight countries including the United States, Canada, Japan, France, Norway, Germany, South Korea and Austria were selected for the analysis. Except the United States PIM criteria has been updated to version 4 (2012), the other countries have just published their first edition. The applicable age of respective country about PIM criteria is slightly different (≥ 65 ~ ≥ 75 years). Seven countries except Japan were using the Delphi method as a research methodology. The composition of the expert panel has pharmacist, geriatrician, psychiatrist, general and family practitioner, and so on. Eight countries′ PIM criteria were not completely consistent in the content and the form, but mainly contain three parts: independent risk factors, drug-disease interactions, and drug-drug interactions. Drugs were included in PIM criteria with the following features: the elderly are proneto poisoning and adverse reactions; the benefits of treatment outweigh its potential risks for the elderly; poor efficacy or uncertain efficacy for the elderly; drugs can be replaced with similar products. ConclusionReference and learning from foreign method and experience of PIM criteria in elderly can help us to formulate a PIM criteria for China′s situation as early as possible and promote rational use of drugs.

  • Qian Fang, Xu Yanli, Song Meihua, Tian Di, Ren Xingxiang, Ge Ziruo, Zhang Tingyu, Wang Aibin, Han Bing, Chen Zhihai
    Adverse Drug Reactions Journal. 2022, 24(4): 169-174. https://doi.org/10.3760/cma.j.cn114015-20211025-01095
    Objective To explore the occurrence and influencing factors of serum uric acid elevation in patients with coronavirus disease 2019 (COVID-19) treated with favipiravir. Methods Medical records of patients with COVID-19 who were hospitalized in Beijing Ditan Hospital between June 1, 2020 and June 30, 2021 and treated with the 5- or 10-day regimen of favipiravir were collected and retrospectively analyzed. After favipiravir withdrawal, if the elevation in serum uric acid was ≥30% of baseline level, it was defined as serum uric acid elevation. Then patients were divided into serum uric acid elevation group and non-serum uric acid elevation group. The clinical characteristics such as gender, age, body mass index, comorbidities, smoking and drinking behavior, COVID-19 grade, favipiravir regimen, and serum uric acid level and renal function before treatment in patients between the 2 groups were compared. Influencing factors of favipiravir-associated serum uric acid elevation was analyzed using multivariate logistic regression method. Results A total of 179 patients were included in the analysis, including 104 (58.1%) males and 75 (41.9%) females, aged from 19 to 70 years with a median age of 43 years. The level of serum uric acid in 179 patients after favipiravir treatment was significantly higher than before [(451±119) μmol/L vs. (332±94) μmol/L, P<0.001]. The change rate of serum uric acid from baseline level ranged from -57.1% to 157.8% with the median of 38.6%. The elevation in serum uric acid of ≥ 30% of baseline level occurred in 108 (60.3%) patients. The incidences of serum uric acid elevation in patients treated with 5-day and 10-day regimens of favipiravir were 46.8% (36/77) and 70.6% (72/102), respectively, and the difference between them was significant (P=0.001). Multivariate logistic regression analysis showed that body mass index 24.0 to <28.0-kg/m2 (OR=3.109, 95%CI: 1.209-7.994, P=0.019) and 10-day regimen of favipiravir (OR=3.017, 95%CI: 1.526-5.964, P=0.001) were independent risk factors for favipiravir-associated serum uric acid elevation. Conclusions More than half of COVID-19 patients treated with favipiravir can develop serum uric acid elevation. Overweight and 10-day regimen of favipiravir are independent risk factors for serum uric acid elevation in patients.
  • Fu Lixiang, Xiao Ping, Sun Jie, Li Guyu, Wei Yuanyuan
    Adverse Drug Reactions Journal. 2022, 24(2): 101-103. https://doi.org/10.3760/cma.j.cn114015-20210315-00305
    A 69-year-old female patient received immunotherapy with intravenous infusion of sintilimab 200-mg once per 21 days because of recurrence of left lung adenocarcinoma after operation. The patient had no history of diabetes mellitus and blood sugar level was normal before treatment. Three days after the first intravenous infusion of sintilimab, the patient felt dry mouth and fatigue, 10 days later her symptoms were worsened, accompanied by nausea. Laboratory examination showed random blood glucose 27.0-mmol/L and hypoglycemic treatment was given. On the 29th day of intravenous infusion of sintilimab, oral glucose tolerance test showed that fasting, 1, 2 and 3 hours postprandial blood glucose levels were higher than those of the upper reference value, C-peptide and insulin were lower than those of the lower reference value, urine routine showed ketone bodies (±) and glucose (++++). Autoimmune diabetes mellitus caused by sintilimab was considered. After several adjustments, the hypoglycemic regimen was finally determined as recombinant human insulin injection 12 units subcutaneously before morning and evening meals, 14 units before lunch; albumin biosynthesis human insulin injection 12 units subcutaneously at bedtime. Five days later, the patient′s symptoms such as dry mouth, fatigue, and nausea disappeared, with fasting glucose 4.8-5.8-mmol/L and postprandial glucose 7.8-8.7-mmol/L. Urine routine examination showed negative ketone body and glucose.
  • . 2017, 19(6): 403.
  • Qu Dongyan, Sun Zhongli, Peng Xiaoye
    Adverse Drug Reactions Journal. 2021, 23(4): 212-213. https://doi.org/10.3760/cma.j.cn114015-20201009-01023
    A 47-year-old male patient with bipolar disorder was given olanzapine tablets 10-mg orally once daily combined with lithium carbonate sustained-release tablets 0.3 g orally once daily due to manic episode. On the 6th day of medication, the patient received irbesartan and hydrochlorothiazide (containing irbesartan 150-mg and hydrochlorothiazide 12.5-mg in each tablet) 1 tablet orally once daily due to elevated blood pressure. Due to the aggravation of the patient′s manic symptoms, the dose of lithium carbonate was increased to 0.9 g/d from the 11th day of medication. After 13 days of combination therapy, the patient′s body temperature rised (up to 39.0-℃) and headache and tremor of both hands appeared. Laboratory test showed that his lithium concentration was 1.58-mmol/L (target plasma concentration was 0.80-1.20-mmol/L) and lithium poisoning was diagnosed. Lithium carbonate sustained-release tablets and other oral drugs were stopped immediately and symptomatic and supportive treatments such as rehydration, cooling, and diuresis were given. Meanwhile, vital signs were monitored. On the 2nd day of drug withdrawal, the plasma lithium concentration decreased to 1.14-mmol/L, the body temperature returned to normal, and the tremor of hands was relieved. On the 8th day after drug withdrawal, the plasma lithium concentration decreased to 0.45-mmol/L, and the symptoms and abnormal signs disappeared.
  • Zhang Qingxia, Bai Xiangrong, Yue Qunying
    Adverse Drug Reactions Journal. 2020, 22(6): 343-349. https://doi.org/10.3760/cma.j.cn114015-20200302-00197
    Objective To analyze the clinical characteristics of fatal cardiac adverse events associated with chloroquine, which was recommended for the antiviral treatment of novel coronavirus pneumonia, and provide reference for clinical safe drug use. Methods The fatal cardiac adverse events associated with chloroquine were searched from the World Health Organization global database of individual case safety reports (VigiBase). The clinical characteristics of the individual cases with well-documented reports (VigiGrade completeness score ≥0.80 or with detailed original reports) were analyzed. The adverse events were coded using the systematic organ classification (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities (MedDRA) version 22.1 of International Conference on Harmonization (ICH). Results Up to 23 February 2020, a total of 45 reports of fatal heart injuries related to chloroquine were reported in VigiBase, which were from 16 countries. Of them, 30 reports were fully informative. Among the 30 reports, 20 cases developed fatal cardiac adverse events after a single large dose of chloroquine. Of them, 17 cases′ fatal cardiac adverse events were caused by overdose of chloroquine (15 cases were suicide or suspected suicide, and 2 children took chloroquine by mistake); 3 cases′ fatal cardiac adverse events were caused in clinical treatment; 18 cases showed arrhythmia and cardiac arrest; 6 cases showed prolonged QRS wave or QT interval; 6 cases were with hypokalemia, including 4 severe ones. Among the 30 reports, 10 cases deve- loped fatal cardiac adverse events after multiple administration of chloroquine, of which 4 cases were treated with chloroquine for 23 days to 2 months and died of heart failure, cardiac arrest or myocardial infarction; 6 cases were treated with chloroquine for 20 months to 29 years and all of them had cardiomyopathy, which were confirmed by endomyocardial biopsy to be caused by chloroquine in 3 cases. Conclusion Cardiac toxicity was the primary cause of fatal adverse events caused by chloroquine; the main manifestation of single large dose of chloroquine was arrhythmia and the manifestation of multiple administration was cardiomyo- pathy.
  • Chen Weibi, Liu Miao, Wang Yan'gai, Zhang Yan, Su Yingying
    Adverse Drug Reactions Journal. 2021, 23(12): 670-672. https://doi.org/10.3760/cma.j.cn114015-20210218-00179
    A 15-year-old female patient with autoimmune encephalitis received methylpredniso- lone combined with plasma exchange and symptomatic treatments for convulsions, abnormal mental behavior, and involuntary facial and limb movements, including levetiracetam 0.5 g orally once per 12-hours, intramuscular injection of phenobarbital injection 0.1 g once per 6 hours, clonazepam 2-mg orally once per 8 hours, and gabapentin capsules 0.3 g orally once per 8 hours. Four days later, the dose of gabapentin was doubled; 7 days later, the patient had menstruation, but the amount of menstruation was very small; 10 days later, the patient developed lactation with serum prolactin 36.69-μg/L. Hyperprolactinemia was then diagnosed, which was considered to be related to gabapentin. Gabapentin was stopped and other drugs were continued. Six days later, the patient′s lactation disappeared and prolactin was 15.65-μg/L. In the following month, the patient′s menses returned to normal.
  • Xie Han, Xue Min, Ma Zhengliang, Qiu Yudong, Ge Weihong
    Adverse Drug Reactions Journal. 2021, 23(8): 433-435. https://doi.org/10.3760/cma.j.cn114015-20201111-01130
    In the past, clinical pharmacists were less involved in the perioperative pharmaceutical management for surgical patients, mainly related to the analgesic management of postoperative pain. In recent 2 years, clinical pharmacists have found that the perioperative patients often suffer from other underlying diseases and need long-term medication. The lack of perioperative pharmaceutical management and evaluation may increase the risk of intraoperative accidents or postoperative complications in some patients. In May 2020, a female patient with rheumatoid arthritis in Nanjing Drum Tower Hospital Affiliated to Medical College of Nanjing University failed to fully evaluate the risk of difficult airway caused by long-term use of prednisolone tablets before operation developed difficulty with facemask ventilation and tracheal intubation after anesthesia, and the operation was forced to be terminated. This incident attracted great attention from pharmacists, so they began to implement comprehensive pharmaceutical management for perioperative patients, including formulating a number of management specifications for common perioperative drugs, opening a perioperative pharmaceutical care clinic for daytime surgical patients, and implementing comprehensive perioperative pharmaceutical management for surgical inpatients. Half a year after clinical pharmacists strengthened the perioperative pharmaceutical management, the satisfaction of surgeons, nurses, and patients with their works were 98.2%, 99.1%, and 93.9%, respectively.
  • 调查研究
    Cai Haodong
    . 1999, 1(2): 92-97.
    Objective: To analyze the causes of the adverse reactions induced by Qingkailtng injection and research the ways of prevention and treatment. Methods: This article summarized 136 cases of the adverse reactions caused by Qingkailing injection in recent years, analysed the category, the clinical characteristics and causes of the adverse reactions induced by Qingkailing injection. Results: The major adverse effects of Qingkailing injection were allergic reaction type I , and were related to the allergic history and CNS diseases of the patient, diluted concentration of the drug, and other drugs combined with Qingkailing injection. Conclusion: The components and formula of Qingkailing injection should be studied in order to reduce the adverse reactions.
  • Zhang Lan, Dong Xianzhe, Wang Zhizhou
    Adverse Drug Reactions Journal. 2023, 25(3): 129-132. https://doi.org/10.3760/cma.j.cn114015-20230103-01203
    It was a very common phenomenon that an original drug was replaced by a generic drug after its patent expires. In order to further verify the efficacy and safety of domestic generic drugs selected in the national centralized volume-based procurement, the National Healthcare Security Admini stration guided a number of medical institutions to carry out large-scale real-world studies on clinical efficacy and safety of generic drugs, involving drugs for treating cardiovascular and cerebrovascular diseases, neuropsychiatric diseases, chronic hepatitis B, and tumor, and anesthetics. More than 110 thousands patients were included in the study. Evidence from real world studies and randomized controlled trials can complement each other. Because of the diversity of data, the complexity of design, the high requirements of analytical methods, and the uncertainty of the interpretation of results in the real world studies, higher requirements for the safety and efficacy evaluation and regulatory decision-making of generic drugs are put forward. Possible recommendations to constantly promote the scientificalness and standardization of the production and use of real world evidence are as follows: further strengthen the informatization construction in medical institutions and promote the standardization and convenience in real world data use, improve the scientificalness of research design and data processing, explore and improve the real world evidence quality evaluation criteria, strengthen the awareness of data security and pay attention to the participants′ privacy protection, etc.
  • Li Yun, Jin Yueping, Ge Qinggang, Liu Fang, Cheng Yinchu, Yang Li, Zhao Rongsheng
    Adverse Drug Reactions Journal. 2020, 22(6): 333-342. https://doi.org/10.3760/cma.j.cn114015-20200608-00646
    Objective To systematically evaluate the efficacy and safety of arbidol in the treatment of novel coronavirus pneumonia (COVID-19). Methods Randomized controlled trials (RCTs), cohort studies, and case-control studies on the efficacy and safety of arbidol for COVID-19, influenza, and other respiratory virus infections were collected by searching related database at home and abroad and network platform for preprint of Health Science Papers (medRxiv) (up to April 25, 2020). Quality of the enrolled studies was evaluated by bias risk assessment tool of Cochrane collaboration network and Newcastle- Ottawa Scale (NOS). Meta-analysis and descriptive analysis of relevant outcome indicators were performed using RevMan 5.3-software. Results A total of 15-studies were enrolled in the study, including 7 cohort studies with high-quality and 8 RCTs, 6 of which were with low bias risk and the other 2 of which were with medium bias risk. Among these studies, 8 were on arbidol treatment for COVID-19, including 5 retrospective cohort studies, 2 prospective cohort studies, and 1 RCT, and involving 809 patients (479 patients in the arbidol group and 330 in the control group); 7 were RCTs on arbidol treatment for influenza or other respiratory virus infections, involving 1-471 patients (745 patients in the arbidol group and 726 in the control group).In these studies, patients were treated with arbidol (0.15-1.2 g daily for 5-21 d) in the arbidol group while with the other antiviral agents or without any antiviral drug in the control group. Meta analysis on the efficacy and safety of arbidol in treatment for COVID-19-showed that the novel coronavirus (2019-nCoV) nucleic acid negative conversion rate in the arbidol group was significantly higher than that in the control group [71.7% (109/152) vs. 58.8% (94/160), relative risk (RR)=1.30, 95% confidence interval (CI): 1.01-1.67, P=0.04]; the difference of time taken for 2019-nCoV nucleic acid negative conversion between the 2 groups was not statistically significant (standardized mean difference=-0.17, 95%CI: -0.72-0.38, P=0.55); the difference of disease improvement rate shown by chest CT on day 7 after treatment between the 2 groups was not statistically significant [46.2% (30/65) vs. 50.7% (36/71), RR=0.88, 95%CI: 0.39-1.98, P=0.76]; and the difference of incidence of adverse reactions between the 2 groups was not statistically significant [16.9% (39/231) vs. 19.2% (47/245), risk difference (RD)=-0.03, 95%CI: -0.10-0.04, P=0.44]. Meta analysis on the safety of arbidol in treatment for influenza and other respiratory virus infections showed that the incidence of adverse reactions in the arbidol group was significantly lower than that in the control group [5.9% (44/745) vs. 11.3% (82/726), RR=0.52, 95%CI: 0.37-0.74, P<0.01]. Conclusion Arbidol could effectively increase the 2019-nCoV nucleic acid negative conversion rate and it might be safe to treat COVID-19 using arbidol.
  • 论著
    Zhang Xiaolan;Wang Yuqin;Yan Yan;Shen Qian;Li Xiaoling;Liu Chen;Li Xingwei;Xie Hongjuan
    . 2014, 16(2): 79-7.

    ObjectiveTo develop primary standard of potentially inappropriate medication (PIM) in Chinese aged people under morbid state and provide the basis and guide for clinical rational drug use in aged people.MethodsStandards of PIM in aged people under morbid state of the United States, Canada, Thailand, South Korea, and the Taiwan area of China were collected and, after summarizing, removing duplication, and integrating, the first round questionnaire was designed according to Delphi method to ask for the experts′ opinions. The experts′ feedback and suggestions were organized and the second round questionnaire was designed to ask for opinions again. Authoritative coefficient, positive coefficient, coordinate coefficient, mean score, and full mark rate were calculated. The selected drugs were respectively divided into grade A (frequency ≥ 3 000) and B (frequency < 3 000) standard according to medication frequency.ResultsThirty nine and 38 experts respectively took part in the 2 rounds of Delphi method investigations, who were selected from 23 grade Ⅲa hospitals in 11 provinces and 3 municipalities directly under the central government. These experts′ specialties involved 11 clinical medical specialties including neurology, psychiatry, cardiology, gastroenterology, endocrinology, urogenital epidemiology, gerontology, general medicine, pain medicine, dermatology, and respiratory medicine and 3 pharmacy specialties including clinical pharmacy, clinical pharmacology, and hospital pharmacy. After the 2 rounds of investigations, all of the authoritative coefficients of the experts were above 0.7, all of positive coefficients were 100%, and the first coordination coefficient were 0.17 and 0.21, respectively. Meanwhile, the mean scores were 3.65 and 3.94 and the means of full mark rates were 0.15 and 0.32, respectively. The first round investigation contained 188 points of drug-induced risks of 89 species (categories) of drugs under 31 kinds of morbid states and the second round investigation contained 74 points of drug-induced risks of 44 species (categories) of drugs kinds of morbid states. These indexes listed in the second round investigation were all enrolled the primary standard of PIM in Chinese aged people under morbid state. Grade A standard contained 62 points of drug-induced risks of 35 species (categories) of drugs under 25 kinds of morbid states, and grade B standard contained 12 points of drug-induced risks of 9 species (categories) of drugs under 9 kinds of morbid states.ConclusionsThe development of primary standard of PIM in Chinese aged people under morbid state has completed preliminarily. However, the standard still needs to be improved by clinical application to be used as a powerful tool for promoting rational drug use and lowering drug-induced risks of aged people.

  • 调查研究
    Liang yan;Lu Yunlan;Che Wenxi
    . 2004, 6(6): 374-378.
    Objective: To analyse the causative drugs, clinical manifestations and precautions of liver damage. Methods: 111 reports of drug-induced liver damage were presented by clinical departments in the hospital from January 2000 to December 2003 and retrospectively reviewed. Results: In 111 cases there were 58 males and 53 females,with a mean age of 46.96 years(range 8-82). 77drugs were involved,mainly antibacterials (18/111 cases,accounting for 16.22%),hormones and other related substances(17/111,15.32%), drugs acting on the CNS ,traditional Chinese medicines and antineoplastics (12/111,10.81%). Classification of drug-induced liver damage was made: hepatocellular damage(40 cases,36.04%),cholestatic damage (43cases, 38.74%)and mixed type damage(28cases, 25.22%). Conclusion: Routine liver function test, early diagnosis, immediate discontinuance of the causative drug and timely treatment are the key to management of drug-induced liver damage.
  • Xu Yifan, Xing Huichun
    Adverse Drug Reactions Journal. 2022, 24(5): 258-263. https://doi.org/10.3760/cma.j.cn114015-20220119-00063
    Drug-induced liver injury (DILI) is caused by the direct toxicity of drugs and/or their metabolites or the body-specific heterogeneous response to drugs. Since 2019, the European Association for the Study of the Liver, the American College of Gastroenterology, and the Asia Pacific Association of Study of Liver have successively updated previously published guidelines on DILI. Based on the above 3 updated guidelines and in combination with Chinese Diagnosis and Treatment Guideline on Drug-Induced Liver Injury, the Guideline for Primary Care of Drug-Induced Liver Injury (2019), and the relevant literature at home and abroad in recent years, we review the progress on the diagnosis and treatment of DILI in this paper, aiming to help the diagnosis and treatment of DILI in clinic.
  • 安全合理用药
    . 2007, 9(1): 32-35.
    重组人血管内皮抑素(YH-16,商品名:恩度,ENDOSTAR),是一种多靶点的血管内皮抑制剂。具有抑制内皮细胞迁移,诱导其凋亡,发挥其抗肿瘤血管生成作用,是用于非小细胞肺癌临床治疗的靶向药物之一,可以明显提高非小细胞肺癌的治疗有效率。但YH-16的不良反应也不应忽视,尤其是对心血管系统具有一定程度的毒副反应。临床使用中应加强患者心血管系统生理状况的评价,进行心电图监测,避免与蒽环类等具有心肌毒性的化疗药物联合使用,以减少不良反应的发生。
  • 安全用药
    Ma Lili;Zhang Jian
    . 2010, 12(3): 178-5.
    Carbapenems are a class of βlactam antibiotics with a broad spectum of antibacterial activity. The commonly used carbapenems are imipenem, meropenem, ertapenem, faropenem, panipenem, doripenem, and so on. Carbapenem antibiotics could induce neurotoxicity and the incidence is about 0.01%-0.3%. The main clinical manifestations of neurotoxicity are headache, convulsions, seizures, myoclonus, and disorder of consciousness. The mechanism of neurotoxicity induced by carbapenem antibiotics is thought to be related to inhibition of the γ-aminobutyric acid (γ-GABA) binding to the receptors and interruption neural inhibitory effect of γ-GABA eventally resulting in seizures and other neurological disorders. The risk factors for neurotoxic reactions include decreased renal function, pathologic changes in CNS, and combination therapy. The prevention and treatment of neurotoxicity induced by carbapenems are as follows: it is essential to consider appropriate choice of carbapenem antibiotics according to the relationship between seizures and the different types of the antibiotics; dosage should be carefully adjusted in patients with renal failure; concomitant use with other drugs such as highdose theophylline, NSAIDs, probenecid, and so on should be avoided; the children and elderly patients should be monitored during treatment; if carbapeneminduced seizures occur, the agent should be stopped and diazepam or sodium valproate may be given if necessary; hemodialysis could be used for patients with uncontrolled seizures induced by the antibiotics.
  • Wen Huiping, Lyu Xinzhi, Chen Yiling, Huang Xuejuan, Huang Wenhui
    Adverse Drug Reactions Journal. 2021, 23(5): 271-272. https://doi.org/10.3760/cma.j.cn114015-20201128-01184
    A 68-year-old male patient with severe active ulcerative colitis developed sleep disorder after using hormone pulse therapy. He received dexzopiclone 3-mg orally once a night to improve sleep. On the next day of medication, the patient developed ataxia symptoms such as dizziness, head drooping, and body skewing when walking, etc. The patient had a history of Parkinson′s syndrome and treatment effect of levodopa and benserazide hydrochloride was good. Dyskinesia caused by levodopa and benserazide hydrochloride were suspected. Then the drug was stopped and symptomatic treatments were given for 3 days, but his symptoms were not improved. After consultation with the neurologist, the patient was diagnosed as having ataxia, which was suspected to be related to dextrzopiclone. Four days after dextrzopiclone withdrawal, the patient′s symptoms were improved obviously. The patient resumed to use levodopa and benserazide hydrochloride before discharge and the ataxia symptoms above mentioned did not recur.
  • 综述
    . 2002, 4(4): 217-220.
    本文对已在临床应用的抗肿瘤药物所出现的不良反应结合文献进行复习,分常见的和少见的不良反应,并提出相应的预防及处理方法,供临床医务人员参考。
  • 安全用药
    . 2006, 8(3): 188-191.
    治疗心血管病常用药物在医治躯体疾病的同时,可能影响病人的性生活质量,其中用于冠心病二级预防的药物尤为明显。本文综述了近年来治疗心血管病常用药物对性功能的影响、作用机制及防治方法。
  • . 2016, 18(6): 401.
  • Wang Chunxiang, Hu Xuelian, Li Zhenzhi, Liu Shujie, Liu Yuling, Meng Chunming, Xue Gang
    Adverse Drug Reactions Journal. 2021, 23(11): 577-583. https://doi.org/10.3760/cma.j.cn114015-20211008-01046
    Objective To understand the usage status of high-alert medicines (HAM) for children in outpatient and emergency prescriptions and inpatient medication orders at department of pediatric. Methods All outpatient and emergency prescriptions and inpatient medication orders in patients with an age of <18 years between July 1, 2016 and June 30, 2018 in Huairou Maternal and Child Health Hospital Affiliated to Beijing Obstetrics and Gynecology Hospital, Capital Medical University were collected. According to the List of High-Alert Medications for the Chinese Children, the use of HAM for children in prescriptions and medication orders was analyzed retrospectively. Results A total of 297-968 prescriptions and medication orders were collected in the study, including 270-024 outpatient and emergency prescriptions (90.62%) and 27-944 inpatient medication orders (9.38%). There were 162-521 prescriptions (54.54%) involving male children and 135-447 (45.46%) involving female children with an age of (4±3) years, ranged 0-17 years. The number of drugs included in each prescription was (2±1), ranged 1-9. Of the 297-968 prescriptions and medication orders, 23-476 (7.88%) involved HAM for children. The proportion of prescriptions containing HAM for children in outpatient and emergency prescriptions was significantly higher than that in inpatient medication orders [7.92% (21-381/270-024) vs. 7.50% (2-095/27-944), P=0.013]; the proportion of prescriptions and medication orders containing HAM for children in Surgery Department [32.84% (1-220/3-715)] was significantly higher than that in Medicine Department [8.17% (22-043/269-777)] and other departments [0.87% (213/24-476)], and the difference was statistically significant (all P<0.001). The 23-476 prescriptions involved 13 categories and 42 kinds of HAM for children and the total frequency of HAM for children was 26-084. The top 3 drug categories that most frequently used were traditional Chinese medicine injections (8-694, 33.33%), antipyretic analgesic and anti-inflammatory drugs (7-505, 28.77%), and anti-infective drugs (4-011, 15.38%); the top 10 HAM for children that most frequently used were paracetamol, Yanhuning injection (炎琥宁注射液), Xiyanping injection (喜炎平注射液), vitamin K1, vidarabine, tetanus antitoxin, penicillins, phenobarbital, promethazine injections, and heparin. Adverse events occurred in 9 children due to medication errors of HAM for children, which were all grade E, and the drugs involved were Xiyanping injection, paracetamol, and vitamin K1 injection. Conclusions HAM for children was commonly used, among which the traditional Chinese medicine injection-related HAM was used more, and the proportion of prescriptions containing HAM for children was higher in departments of outpatient, emergency, and surgery. Medication errors related to HAM for children may lead to serious adverse events, so the management of HAM for children should be strengthened.
  • Wang Mengmeng, Zhang Yanni, Wu Aixin
    Adverse Drug Reactions Journal. 2021, 23(1): 20-24. https://doi.org/10.3760/cma.j.cn114015-20201119-01156
    Objective To explore the occurrence and clinical characteristics of leukopenia induced by amoxicillin sodium and clavulanate potassium for injection in patients with acute pyelonephritis. Methods The subjects were patients with acute pyelonephritis who used amoxicillin sodium clavulanate potassium for injection during hospitalization in the Department of Nephrology, the University of Hong Kong-Shenzhen Hospital from January to December 2019 and had a white blood cell count (WBC) ≥4.0×109/L before amoxicillin sodium clavulanate potassium for injection administration. Cases of leucopenia caused by amoxicillin sodium clavulanate potassium for injection were collected and the patients′ basic information, duration of treatment with amoxicillin sodium clavulanate potassium for injection, concomitant medications, blood cell count before and after administration, leukopenia occurrence, and interventions and outcomes of leukopenia were extracted from electronic medical records. The incidence of leucopenia was calculated and the clinical characteristics of the adverse reaction were analyzed. Leukopenia was defined as WBC <4.0×109/L (lower limit of WBC reference value in our hospital). Results A total of 134 patients were included in the analysis. Of them, 12 developed leukopenia, the incidence was 9.0%. Among the 12 patients, 1 (8.3%) was male and 11 (91.7%) were female with an age of (35±12) years. The time from drug administration to the onset of leukopenia ranged from 2 to 6 days and it was 3 days in 6 patients (50.0%). The WBC, neutrophil count, and neutrophil proportion were (4.7~17.5)×109/L, (3.1~15.4)×109/L, and (0.60~0.90) before drug administration, and then decreased to (2.3~3.9)×109/L, (0.8~2.4)×109/L, and (0.35~0.65) after drug adminis- tration, respectively. Fifty percent (6/12) of the patients had hemoglobin decrease >20-g/L and (or) erythrocyte count decrease >0.5×1012/L. None of the 12 patients had obvious clinical symptoms, and no other interventions were given after discontinuation of the drug. WBC returned to normal in 11 patients and was unknown in the other 1 patient because the patient was lost to follow-up on day 2 of drug discontinuation after discharge. Conclusions Amoxicillin sodium clavulanate potassium for injection can cause leukopenia in patients with acute pyelonephritis, which mostly occurs within 6 days of medication. It is generally asymptomatic and can recover after drug discontinuation. The prognosis is good.
  • 安全用药
    . 2002, 4(1): 22-25.
    随着人们生活水平的提高,已不满足于单纯的治疗药物,常服用一些抗衰老的保健药品,其中以中药因其“纯天然”的优势越来越受到青睐,一般认为中药药性平和,服用安全,纯中药制剂不会中毒,临床上常用的补益类中药有西洋参、灵芝、冬虫夏草、鹿茸、黄芪、何首乌、党参、白术、熟地、生地、当归、白芍、麦冬、丹参等,但这些补益类中草药在不同程度上都可产生不良反应。本文对近几年来几种补益类中草药的不良反应的国内文献作一介绍,通过病例说明补益药不是可以盲目服用,提倡合理使用补益类中草药。
  • Adverse Drug Reactions Journal. 2020, 22(3): 155-159. https://doi.org/10.3760/cma.j.cn114015-20200224-00161
    我国《新型冠状病毒肺炎诊疗方案(试行第六版)》在中医治疗中推荐了6个品种的口服中成药,包括藿香正气方(胶囊、丸、水、口服液)、金花清感颗粒、连花清瘟方(胶囊、颗粒)、疏风解毒方(胶囊、颗粒)、苏合香丸和安宫牛黄丸。其中藿香正气方、金花清感颗粒、连花清瘟方和疏风解毒方仅推荐在医学观察期使用,但也有用于新型冠状病毒肺炎轻型和普通型患者的报道;而苏合香丸和安宫牛黄丸则仅用于新型冠状病毒肺炎危重症患者。这6种口服中成药的安全性较好,很少有不良反应发生,但临床应用时应注意中医辨证、禁忌证、配伍禁忌,避免主治证型相似的药物叠加使用,加强不良反应的监测。
  • 相互作用
    . 2007, 9(2): 112-116.
    华法林为香豆素类口服抗凝剂,临床上应用越来越广泛,但他与许多药物和食物同时服用均会发生相互作用,从而影响抗凝效果。本文对华法林与西药、中草药和食物的不良相互作用进行概述,一起能为临床安全用药提供参考依据。
  • 综述
    . 2000, 2(3): 149-153.
    我们对近年来中药不良反应文献进行调研,将收集的文献信息进行分类总结,阐述中药不良反应产生的机制及原因,望能引起广大临床医务工作者重视中药不良反应产生的严重后果;减少中药不良反应的发生,促进我国中医药事业的发展。
  • Bao Jiali, Wang Zheyuan, Wang Fangting, Du Qiong, Zhai Qing, Xu Rui
    Adverse Drug Reactions Journal. 2023, 25(6): 359-365. https://doi.org/10.3760/cma.j.cn114015-20221121-01070
    Objective To evaluate the effectiveness of pharmaceutical services of direct to patients (DTP) sale pharmacy, taking the out-hospital pharmacy service of hypothyroidism caused by camrelizumab as an example. Methods The electronic drug records of patients who received camrelizumab (the medicine was purchased  from 3 stores under the Gaoji Suxiang Specialty Pharmacy in Hefei from July 1, 2019 to July 31, 2021) were collected and their medical history information and pharmacy service data provided by DTP pharmacists were recorded. The occurrence, intervention measures, and outcomes of camrelizumab- related hypothyroidism, as well as the patient′s compliance to the intervention were analyzed descriptively. Results A total of 489 patients were entered in the analysis, including 341 males and 148 females, aged (61±12) years with an range from 18 to 75 years. The drug was used for lung cancer in 129 patients, esophageal cancer in 112 patients, liver cancer in 60 patients, nasopharyngeal carcinoma in 8 patients, lymphoma in 4 patients, and other tumors beyond indications in 176 patients. The median treatment time of camrelizumab in these patients was 4 months, ranging from 1 to 24 months. Camrelizumab was used in monotherapy in 129 patients, in combination with chemotherapy in 156 patients, in combination with targeted drugs in 97 patients, in combination with both chemotherapy and targeted drugs in 83 patients, and in combination with both chemotherapy and radiotherapy in 4 patients; the additional treatment plans were unknown in 20 patients. Among the 489 patients, 16 patients experienced hypothyroidism, with an incidence of 3.3%, of which 6 were actively identified by pharmacists in DTP pharmacy. All 16 cases of hypothyroidism were judged to be associated with camrelizumab by the Naranjo causality evaluation method, and the severity was grade 2 in 15 cases and grade 1 in 1 case. The patient with grade 1 hypothyroidism did not receive medical intervention; camrelizumab was stopped due to disease progression, which resulted in an improvement in hypothyroidism. All 15 patients with grade 2 hypothyroidism received treatment with levothyroxine sodium. In the following 1 week, patient compliance was good, average, and poor in 3, 8, and 5 cases, respectively. Pharmacists provided corresponding interventions based on the main items that affected patient compliance. As of the end of this study, among the 15 patients with grade 2 hypothyroidism, the thyroid function turned normal in 4 patients (including 1 who stopped levothyroxine sodium due to arrhythmia), was improved in 2 patients, and had persistent condition in 9 patients. Conclusion Out-hospital pharmaceutical services provided by pharmacists in DTP pharmacy helps to ensure patient compliance and safe medication.
  • 药害史
    . 2010, 12(5): 335-3.
  • Liu Yanqing, Liu Qingping, Ding Xia, Zhang Pingfu, Ma Yanhong
    Adverse Drug Reactions Journal. 2021, 23(3): 154-155. https://doi.org/10.3760/cma.j.cn114015-20200820-00896
    A 76-year-old female patient took soaking water of Tetrastigma hemsleyanum 15 g daily by herself after lung cancer resection and chemotherapy. After 3 months of medication, the patient developed fatigue and dry mouth. After 4 months of medication, decrease of white blood cells and hemoglobin and increase of fasting blood glucose and glycosylated hemoglobin appeared and were gradually aggravated. After 6 months of medication, the white blood cell count was 2.8×109/L, hemoglobin was 88-g/L, red blood cell count was 3.05×1012/L, fasting blood glucose was 10.01-mmol/L, and glycosylated hemoglobin was 6.93%. Diabetes mellitus, leukopenia, and anemia were diagnosed, which were considered to be related to Tetrastigma hemsleyanum. The patient was asked to stop drinking the soaking water of Tetrastigma hemsleyanum and the traditional Chinese medicine decoction was given. Two months later, the patient′s blood cells returned to normal, fasting blood glucose was 6.08-mmol/L, and glycosylated hemoglobin was 6.10%. The prescribed daily dose of Tetrastigma hemsleyanum in Chinese Medicine Record is 3-9 g. Diabetes mellitus and hemocytopenia in the patient might be related to overdose and long-time use of the drug.
  • 专题讲座
    . 2003, 5(2): 101-106.
  • Li Yanjiao, Xing Ruixin, Wang Xinlu, Zhang Wenrui, Sun Lirui
    Adverse Drug Reactions Journal. 2022, 24(2): 74-79. https://doi.org/10.3760/cma.j.cn114015-20211210-01251
    Objective To analyze the clinical characteristics of pulmonary hypertension (PH) induced by dasatinib. Methods The relevant databases at home and abroad (as of December 31, 2020) were searched and the case reports on PH induced by dasatinib were collected. Clinical information including patient′s basic characteristics, dasatinib dose, occurrence time of PH, clinical manifestations, interventions, and outcomes were collected and analyzed by descriptive statistical method. Results A total of 25 patients from 24 case reports were enrolled in the study, including 16 males and 9 females, aged from 23 to 73 years with an average age of 50 years. There were 22 patients with chronic myeloid leukemia (CML) and 3 with acute lymphoblastic leukemia (ALL); the dose of dasatinib was 140-mg daily in 14 patients, 100-mg daily in 7 patients, 70-mg daily in 2 patients, and unknown in 2 patients. Time from dasatinib application to PH occurrence was 10 days to 144 months, with a median time of 37 months. The clinical symptoms included varying degrees of dyspnea in 24 patients, edema in 8 patients, hepatomegaly in 5 patients, jugular vein dilatation in 5 patients, cough in 3 patients,and chest tightness in 3 patients, chest pain in 2 patients, and fatigue in 1 patient. Pleural effusion and/or pericardial effusion were found in 20 patients by chest CT, chest X-ray or echocardiography. Cardiac function was graded as Ⅳ in 8 patients, Ⅲ in 9 patients, and Ⅱ in 4 patients according to WHO classification method, and the grade was unknown in 4 patients. Right cardiac catheterization and/or echocardiography showed elevated mean pulmonary artery pressure and/or systolic pulmonary artery pressure in 25 patients. Twenty-four patients stopped dasatinib following the doctor′s advice after the diagnosis of PH, of which 22 patients were treated with phosphodiesterase 5 inhibitor, endothelin receptor antagonist, diuretic, and glucocorticoid, and the other 2 patients were not given special intervention; one patient took dasatinib intermittently by himself. Nineteen patients were switched to other tyrosine kinase inhibitors. After discontinuation of dasatinib and giving symptomatic treatments for 1 week to 36 months (mean 7 months), 17 patients were improved, 7 were partially improved, and 1 had unknown outcome. Conclusions Dasatinib-related PH was more common in patients with CML, occurred more in male patients, and had a median occurrence time of 37 months after drug administration. The main clinical manifestation was dyspnea, often complicated with pleural effusion or pericardial effusion. After dasatinib withdrawal and specific treatments, most patients could be improved.
  • Fu Zhonghua, Guo Zihan, Wang Mengmeng, Du Qiong, Zhai Qing
    Adverse Drug Reactions Journal. 2023, 25(1): 34-39. https://doi.org/10.3760/cma.j.cn114015-20220822-00771
    Objective To explore the risk signals of brigatinib-related adverse events (AEs) and provide reference for the safe use in clinical practice. Methods The US FDA Adverse Event Reporting System database was searched and AE reports on brigatinib as the primary suspect drug from April 1, 2017 to March 31, 2022 were collected. AEs were standardized and classified according to the preferred terms (PT) and system organ class (SOC) of Medical Dictionary for Regulatory Activities 24.0. Reported odds ratio (ROR) and proportional reporting odds ratio (PRR) methods were used to mine the AE risk signals of brigatinib. An AE with reports ≥3, ROR≥2, 95% confidence interval (CI) lower limit of ROR>1, or reports ≥3, PRR≥2, and χ2>4 was defined as a positive signal. Positive PT signals were analyzed using descriptive method. Results A total of 1-564 AE reports were included in the analysis, involving 672 PTs. After analysis using ROR and PRR methods, 52 PTs with positive risk signals were obtained, involving 16 SOCs. The top 10 PTs in report amount were fatigue, diarrhea, nausea, cough, abnormal serum creatine phosphokinase, dyspnea, headache, rash, vomiting, and hypertension, all of which were common AEs in the instructions. The top 10 PTs in signal intensity were pituitary infarction, radiation necrosis, elevated amylase, esophageal varices, early saturation, elevated lipase, abnormal serum creatine phosphokinase, pulmonary toxicity, prolonged activated partial thromboplastin time, and photosensitivity. Among them, the PTs ranked 1st, 2nd, 4th, 5th, 8th, and 10th were not recorded in the label. Pneumonia and interstitial lung disease (ILD) were serious AEs, with 31 and 8 reports, respectively. In the 52 PTs, 28 were not included in the drug label, involving 12 SOCs. Conclusions The main adverse reactions of brigatinib were diarrhea, nausea, cough, and abnormal serum creatine phosphokinase and serious adverse reactions such as pneumonia and ILD were both reported, which were consistent with the common AE recorded in the drug label. In addition, brigatinib might cause pituitary infarction, radiation necrosis, pulmonary toxicity, photosensitivity, etc., which should be vigilant in clinical practice.
  • 中毒救治
    . 2007, 9(1): 43-45.
    矿物类中药中可含有铅、汞、砷等重金属成分,过量应用会导致药源性铅、汞和砷等重金属中毒。临床上对重金属中毒的误诊率较高,应引起高度重视。通过仔细采集病史,拓宽临床思维,认识矿物类中药重金属中毒的临床表现,结合毒物化学成分的检测结果,可正确诊断药源性重金属中毒,并及时采取特效解毒剂驱排治疗。
  • Wang Xiaofeng, Liu Jing, Liu Chang, Xin Zhong
    Adverse Drug Reactions Journal. 2023, 25(7): 444-445. https://doi.org/10.3760/cma.j.cn114015-20220610-00516
    A 48-year-old male patient received dapagliflozin, metformin and insulin glargine injection due to poor blood glucose control and the blood glucose control was acceptable. After 9 months, the patient′s food intake decreased due to swelling in the gum, and 3 days later, the patient developed nausea, vomi- ting, fatigue, and wheezing. The arterial blood gas analysis showed metabolic acidosis, random blood glucose 15.2-mmol/L, and urinary ketone body (+++). Dapagliflozin and other oral hypoglycemic drugs were stopped, symptomatic treatments such as insulin, fluid replacement, anti-infection, antiemesis, and correction of electrolyte disorder were given, and the patient′s condition was improved. It was considered that dapagliflozin caused ketoacidosis (DKA). The hypoglycemic treatment regimen was changed to subcutaneously injection of insulin aspart 30 injection 22 U in the morning and 16 U at night and oral metformin 0.5 g thrice daily, and the blood glucose control was acceptable. After that, no DKA symptoms recurred in the patient.
  • Bai Fang, Wang Lihua, Tao Hai, Zhou Xibin, Wang Peng, Wang Fei
    Adverse Drug Reactions Journal. 2020, 22(5): 300-305. https://doi.org/10.3760/cma.j.cn114015-20191017-0082
    Objective To explore the clinical characteristics, treatment and prognosis of patients with severe lacrimal duct obstruction caused by tegafur-gimeracil-oteracil potassium (S-1). Methods The medical records and follow-up data of the surgical inpatients with severe lacrimal duct obstruction caused by S-1 in Lacrimal Center of Ophthalmology, the Third Medical Center of Chinese PLA General Hospital from January 2017 to January 2019 were analyzed retrospectively. Results A total of 12 patients were enrolled in this study, including 7 males and 5 females, aged (53±8) years. The time of oral administration of S-1 was (4.1±1.1) months, and the time from the beginning of administration of S-1 to the onset of epiphora symptoms was (53.3±31.2) days. All the 12 patients had binocular diseases (involving 12 cases, 24 eyes) and obstruction of both upper and lower lacrimal canaliculi (involving 48 lacrimal canaliculi). Among the 48 obstructed lacrimal canaliculi, 45 (93.8%) were severe, and 3 (6.2%) were moderate. The 8 lacrimal points of the upper and lower lacrimal canaliculi in both eyes of the 2 patients were completely atresic. In 12 patients, 16 eyes in 8 patients were complicated with complete obstruction of nasolacrimal ducts and 8 eyes in the other 4 patients were complicated with incomplete obstruction of nasolacrimal ducts. Eight patients underwent laser dacryoplasty combined with bicanalicular intubation assisted by lacrimal canaliculus micro-endoscopy. After taking off the tubes, epiphora was relieved in 5 patients but not improved in the other 3 patients. Two patients underwent retrograde exploration to probe canaliculi transdacryocyst combined with bicanalicular intubation. After taking off the tubes, epiphora was relieved. Two patients underwent retrograde exploration to probe canaliculi transdacryocyst combined with dacryocystorhinostomy. After taking off the tubes, epiphora was improved obviously and only slight epiphora was found. Conclusions Severe lacrimal duct obstruction caused by S-1 was characterized by extensive multiple obstruction. Appropriate surgical treatment can improve the symptoms of epiphora in some patients.
  • Yu Yongchun, Gao Daiquan
    Adverse Drug Reactions Journal. 2020, 22(11): 654-655. https://doi.org/10.3760/cma.j.cn114015-20200223-00157
    A 76-year-old male patient with unstable angina pectoris switched to an IV infusion of imipenem and cilastatin sodium 1.0 g once every 8 hours because of the ineffective treatment of pneumonia with amoxicillin and clavulanate potassium combined with levofloxacin. The platelet count (PLT) was 109×109/L before treatment. After 9 days of medication, the patient′s symptoms of cough and dyspnea were improved, his body temperature returned to normal, but he developed skin petechiae, accompanied by a small amount of epistaxis and hematuria. At the same time, his PLT was 0. Imipenem and cilastatin sodium was immediately discontinued, recombinant human thrombopoietin combined with methylpredniso- lone and human immunoglobulin were given, the patient′s PLT gradually increased and the bleeding symptoms disappeared. Ten days later, his PLT was 173×109/L. It is suggested that high-dose imipenem and cilastatin sodium should be used cautiously in elderly patients and the monitoring should be strengthened during the treatment.
  • Lyu Zhijie, Wang Tiantian
    Adverse Drug Reactions Journal. 2022, 24(6): 327-329. https://doi.org/10.3760/cma.j.cn114015-20220128-00086
    A 72-year-old male patient took colchicine 1-mg once daily orally by himself due to the acute attack of gouty arthritis. Thirty-two days later, the patient developed diarrhea. He increased the colchicine′s dose to 1-mg thrice daily orally by himself because of aggravation of arthritis pain. Then the patient′s diarrhea was worsened and muscle pain appeared. Laboratory tests showed white blood cell count (WBC) 2.5×109/L, platelet count (PLT) 76×109/L, alanine aminotransferase (ALT) 429-U/L, aspartate aminotransferase (AST) 595-U/L, γ-glutamyl transpeptidase(γ-GT) 375-U/L, alkaline phosphatase (ALP) 265-U/L, creatine kinase 2-300-U/L, lactate dehydrogenase (LDH) 777-U/L, serum creatinine (Scr) 299 μmol/L, urine occult blood (+++), and urine protein (++). Colchicine plasma concentration was 5.9-ng/ml and urine concentration was 81.8-ng/ml. Rhabdomyolysis and multiple organ dysfunction syndrome secondary to colchicine poisoning was considered. Colchicine was stopped, and the patient′s diarrhea was improved 2 days later. The patient also received symptomatic support therapy, plasma exchange, and bedside continuous renal replacement therapy for 6 times. After 23 days of drug withdrawal, symptom of muscle soreness was improved and the laboratory tests showed WBC 5.6×109/L, PLT 266×109/L, ALT 40-U/L, AST 19-U/L, γ-GT 135-U/L, ALP 133-U/L, creatine kinase 66-U/L, Scr 138-μmol/L, negative urine occult blood, and weakly positive urine protein.
  • Gao Dandan, Jin Lifang, Wang Chunhong, Guo Xurui, Shen Weizhang
    Adverse Drug Reactions Journal. 2020, 22(11): 642-643. https://doi.org/10.3760/cma.j.cn114015-20200628-00728
    A 48-year-old female patient received chemotherapy with etoposide and carboplatin combined with whole brain radiotherapy for small cell lung cancer located in the right lung with brain metastasis. An IV infusion of toripalimab 240-mg once per 21 days in the 4th cycle of chemotherapy was combined due to tumor progression, and no radiotherapy was given again. After 7 courses of chemotherapy, the patient received monotherapy with toripalimab. On the 2nd day after the 5th administration of toripalimab, the patient developed obvious fatigue, nausea, vomiting, and repeated fever. Laboratory tests showed decreased corticotropin and cortisol (1.5-μg/L, 3.9-μg/L), increased prolactin (127.6-μg/L), and normal thyroid function. Excluding tumor occupation by pituitary magnetic resonance imaging, it was considered as hypophysitis caused by toripalimab. Symptoms disappeared after hydrocortisone replacement therapy was given. After the 9th administration of toripalimab, the patient developed polyuria, thirst, and nocturia. Laboratory tests showed decreased urine specific gravity and urine osmolality (1.010, 132-mmol/L). Diabetes insipidus as the manifestation of hypophysitis caused by toripalimab was considered. The above symptoms were improved after discontinuation of toripalimab and administration of desmopressin. After more than 3 months of the treatment, symptoms of diabetes insipidus disappeared. Then desmopressin was discontinued and diabetes insipidus did not recur.
  • Zheng Xizi, Xu Lingyi, Zhou Qingqing, Yang Li
    Adverse Drug Reactions Journal. 2024, 26(5): 261-267. https://doi.org/10.3760/cma.j.cn114015-20240319-00178
    Antineoplastic agents; Acute kidney injury; Renal insufficiency; Guideline; Interpretation
  • Zhuang Wei, Lai Xiuping, Ye Suiwen, Chen Junyi, Mai Qingxiu, Li Siming, Wu Junyan, Yao Herui
    Adverse Drug Reactions Journal. 2021, 23(9): 456-460. https://doi.org/10.3760/cma.j.cn114015-20210322-00345
    Objective To explore the correlation between immediate hypersensitivity induced by pegylated liposomal doxorubicin (PLD) and the plasma anti-polyethylene glycol (anti-PEG) antibody in advanced breast cancer patients. Methods The study was designed as a prospective and noninterventional study. The subjects were selected from advanced breast cancer patients in Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, who received monotherapy with PLD (an IV infusion of PLD 50 mg/m2 in 5% glucose solution 250 ml for 90 minutes without pretreatment with dexamethasone or other drugs). Anti-PEG antibody before administration were detected for all the patients and antibody level >2-ng/L was defined as positive. Blood in patients who had hypersensitivity within 30-minutes after the start of infusion was collected (finding the opportunity as soon as possible) and IgE, C3, and C4 levels in serum were detected. According to whether there was an immediate hypersensitivity reaction, the patients were divided into hypersensitivity group and non-hypersensitivity group and the clinical characteristics and plasma anti-PEG antibody carrying status in patients between the 2 groups were compared; according to anti-PEG antibody carrying status, the patients were divided into anti-PEG antibody positive group and negative group and the clinical characteristics and the incidence of hypersensitivity in patients between the 2 groups were compared. Results A total of 12 patients were included in the study, aged from 37 to 68 years with a median age of 50 (37-68) years. Ten patients had previously used non-pegylated anthracyclines and the median cumulative dose was 329 (185, 418) mg/m2 after a doxorubicin equivalent dose conversion. Seven patients developed hypersensitivity within 2-18-minutes after the start of infusion. Between the hypersensitivity group and the non-hypersensitivity group, differences in clinical characteristics such as age, height, weight, body surface area, previous application of anthracyclines, and the cumulative doses in patients were not significant (all P>0.05); the difference in positive rate of anti-PEG antibodies in patients was also not statistically significant (4/7 vs. 2/5, P=1.000). Among the 12 patients, 6 were positive for anti-PEG antibody and 6 were negative and the differences in the above-mentioned clinical characteristics or the incidence of hypersensitivity (3/6 vs. 4/6) in patients between the 2 groups (all P>0.05) were not significant. In the hypersensitivity group, IgE, C3, and C4 levels in serum were detected in 4 patients. Two patients with positive anti-PEG antibody had increased IgE levels (404 and 545 μg/L, respectively), 1 of which had also increased C4 level (486-mg/L); the other 2 patients with negative anti-PEG antibody had normal IgE, C3, and C4 levels. Conclusions It has not been found that PLD-induced immediate hypersensitivity is related to the anti- PEG antibody, which may be due to the small sample size of the study. It cannot be ruled out that anti-PEG antibody may be involved in the induction of the IgE-mediated immediate hypersensitivity, which may also be mediated by complement in some patients.
  • Tian Yingchao, Zeng Bingqing, Zhang Kai, Tang Zhihui
    Adverse Drug Reactions Journal. 2020, 22(10): 591-592. https://doi.org/10.3760/cma.j.cn114015-20191009-00804
    A 29-year-old female patient took vitamins with minerals tablets (29) (each tablet contains 150-μg of iodine) for nearly one year because she was preparing for pregnancy. Abnormal thyroid function was found in pre-pregnancy examination. Her free thyroxine (FT4) was 23.2-pmol/L, free triiodothyronine (FT3) was 5.56-pmol/L, and thyroid stimulating hormone (TSH) was 0.10 mU/L. According to the doctor′s advice, she stopped taking vitamins with minerals tablets (29) immediately. Five days after discontinuation of the drug, her FT4 was 21.2-pmol/L, FT3 was 5.39-pmol/L, TSH was 0.08 mU/L, and thyrotropin receptor antibody was <0.3-U/L. The results of re-examination on day 59 after drug withdrawal showed FT4-16.35-pmol/L, FT3-4.97-pmol/L, and TSH 2.36 mU/L. It was considered that the patient′s thyroid dysfunction was caused by vitamins with minerals tablets (29).
  • Liu Bo, He Huaiwu, Long Yun
    Adverse Drug Reactions Journal. 2021, 23(2): 104-105. https://doi.org/10.3760/cma.j.cn114015-20200305-00217
    A 48-year-old male patient with myocardial infarction received continuous intravenous pumping of propofol 1-2-mg/(kg· h) for 21 days due to delirium after cardiopulmonary resuscitation. On the 19th day after intravenous pumping of propofol, the patient developed high fever (the highest body temperature was 40.0-℃), decreased blood pressure (the lowest level was 90/60-mmHg), decreased urine volume (10-ml/h), and dark urine. The laboratory tests showed white blood cell count (WBC) 17.3×109/L, hemoglobin (Hb) 88-g/L, procalcitonin (PCT) 12.76-μg/L, cardiac troponin I (cTnI) 0.342-μg/L, serum creatinine (Scr) 239-μmol/L, creatine kinase (CK) 34-667-U/L, myoglobin (myo) 58-284-μg/L, lactic acid 2-mmol/L, and fungal (1-3)-β-D-glucan 457.9-ng/L. Candida albicans was identified from blood culture. The patient was diagnosed with propofol infusion syndrome and sepsis. Propofol was stopped immediately and replaced by continuous intravenous pumping of midazolam injection (5-mg/h). At the same time, treatments such as anti-infection and continuous bedside hemofiltration were given. After 3 days of treatments, the patient′s temperature dropped to within the normal range. After 7 days of treatments, laboratory tests showed WBC 5.6×109/L, Hb 95-g/L, PCT 0.12-μg/L, cTnI 0.023-μg/L, CK 43-U/L, myo 151-μg/L, Scr 78-μmol/L, and fungal (1-3)-β-D-glucan 88.9-ng/L. His urine volume was 90-100-ml/h.
  • 论著
    Liu Jiaming;Yan Suying;Liu Chen;Liu Ning;Li Xiaoling;Bai Xiangrong;Wang Yawei;Li Xingwei;Cheng Hongqin;Tang Jing;Chu Yanqi;Wang Yuqin
    . 2014, 16(4): 198-7.
    ObjectiveTo investigate the feasibility of detecting adverse drug event (ADE) using Global Trigger Tool (GTT) in Chinese medical institutions.MethodsDischarged patients′ records of the Xuanwu Hospital of Capital Medical University from January 1st to December 31st 2013 were collected. After sorting by discharged date, 30 cases were selected in a half month period by a random sampling tool of Microsoft Excel 2007 software. Unqualified cases were eliminated according to the inclusion criteria (patients aged 18 and over, one time admission in 2013, and hospitalization for more than 1 day) and exclusion criteria (patients in the Department of Obstetrics, Family Planning, Rehabilitation, Oncology, Pediatrics, and day-care ward). The 20 cases were reviewed every half a month in sequence of random sampling using 35 triggers, including laboratory indexes, antidotes, clinical symptoms, and treatment measures, that were identified by GTT recommendation, relevant foreign researches, and self-experience of Xuanwu Hospital of Capital Medical University. All cases were enrolled if the number of cases which met the inclusion criteria was less than 20. The cases in whom triggers could be detected were marked as the cases with positive triggers. The cases with positive triggers-related situations were further reviewed in order to identify or exclude ADE and then the identified ADEs were classified. The positive triggers and ADEs were analyzed by Microsoft Excel 2007 software and the positive predictive values of positive triggers were calculated.ResultsTotally 465 cases were reviewed. Of them, 256 were male and 209 female with the mean age of 57 (19~92) years. The time of hospital stay was 2 to 37 days with the mean hospital stay of 10 days. Of the 465 patients, in 208 patients(44.7%)positive triggers could be detected. Of all the 35 triggers, 22 triggers (62.9%) were positive referring to 342 times. There were 18 ADEs identified involving 16 patients and the detectable rate was 3.4% (16/465). Of the 18 ADEs, 13 ADEs had their corresponding triggers containing 8 triggers. The overall positive predictive value of 22 positive triggers was 3.8%. The 18 ADEs included pneumonia (2 ADEs), liver injury (2 ADEs), chill (2 ADEs), skin rash (2 ADEs), antibiotic-associated diarrhea (1 ADE), headache (1 ADE), dizziness (1 ADE), nausea and vomiting (1 ADE), hypoglycemia (1 ADE), over-sedation (1 ADE), delirium (1 ADE), bleeding (1 ADE), leucopenia (1 ADE), and excitation (1 ADE). There were 14 ADEs of class E and 4 ADEs of class F in the 18 ADEs which referred to 21 drugs including 5 kinds of antibacterial agents, 3 kinds of blood system drugs, 3 kinds of psychotherapeutic agents, 2 kinds of cardiovascular drugs, 2 kinds of hormone drugs, 2 kinds of Chinese patent medicines, 1 kind of lipid drug, 1 kind of drug acting bone metabolism, 1 kind of antipyretic analgesic, and 1 kind of anesthetic.ConclusionsGTT could help to early detect the signals of ADEs and provide the reference evidence of preventing drug risk. It is valuable that GTT is popularized and used in Chinese medical institutions.
  • Ruan Shishuang, Di Li, Wang Yan, Fan Limei
    Adverse Drug Reactions Journal. 2022, 24(9): 478-483. https://doi.org/10.3760/cma.j.cn114015-20220510-00413
    Objective To understand the awareness and application status of drugs used with caution in myasthenia gravis (MG) patients. Methods The list of drugs that should be used with caution in MG patients was formulated through discussion among pharmaceutical experts and neurology experts in Xuanwu Hospital, Capital Medical University, including 10 categories and more than 50 drugs like anti- infective drugs, cardiovascular drugs, sedative-hypnotics, statins, antiepileptics, antipsychotics, analgesics, anaesthetics, spasmolytics, and others. The questionnaire survey on knowledge of drugs used with caution was conducted in outpatients with MG in the Department of Neurology between January 2021 and February 2022 in Xuanwu Hospital, Capital Medical University. The contents of the questionnaire included the general demographic data of patients, the disease course and type of MG, comorbidities, drug utilization, awareness and application of drugs used with caution in MG patients, and accesses to relevant drug use knowledge. The questionnaire was distributed on-site after the patient ended the visit, and the patients were asked to participate voluntarily and answer and return the questionnaire on the spot. The participants were divided into the with and without relevant knowledge groups according to whether they were aware of drugs used with caution in MG patients, and the clinical characteristics of the patients in the 2 groups were compared. Multivariate logistic regression analysis was used to analyze the influencing factors of awareness of drugs used with caution, and the odds ratio (OR) and 95% confidence interval (CI) were calculated. Results A total of 290 questionnaires were distributed and all of them were recovered. Among the 290 patients, 165 were male and 125 were female, and the disease course of MG ranged from 3 weeks to 360 months. The clinical subtypes were ocular MG in 179 patients and non-ocular MG in 111 patients. One or more chronic disease coexisted in 174 patients (60.0%), including hypertension, hyperlipidemia, diabetes mellitus, coronary atherosclerotic heart disease, immune system disease, anxiety/depression, etc. There were 248 patients (85.5%) who had received medications for MG. In the MG patients having access way to knowledge about drugs used with caution, there were 191 (92.7%), 26 (12.6%), 22 (10.7%), and 7 (3.4%) patients through the propagation by healthcare staff, bulletin boards/display boards in the hospital, networks, and books, respectively. There were 64.8% (188/290) of the patients knowing nothing about the drugs used with caution. After the diagnosis of MG, 110 patients had used the drugs that should be used with caution, and 7 (6.4%) had aggravated MG or adverse reactions later, of which 4 applied eye drops (quinolones and macrolides in 2 patients respectively). The independent influencing factors of low awareness of drugs used with caution were not receiving drugs for MG and not obtaining precautions in medication at the time of diagnosis (OR=6.811, 95%CI: 2.252-20.593, P=0.001; OR=5.615, 95%CI: 3.223-9.785, P<0.001). Conclusion Patients with MG have low awareness of the drugs used with caution, and neurology staffs should take more effective measures to the patient education about drugs used with caution.
  • He Zhiyao, Chen Yuxian, Yan Yu, Qin Zhou, Xu Ting
    Adverse Drug Reactions Journal. 2021, 23(4): 210-211. https://doi.org/10.3760/cma.j.cn114015-20200821-00901
    A 66-year-old male urothelial carcinoma patient with liver and lymph node metastasis received an IV infusion of paclitaxel for injection (albumin bound) 400-mg on day 1 and tegafur, gimeracil and oteracil potassium capsules 50-mg orally twice daily on day 1 to day 14, the interval was 1 week, and each cycle was 21 days. A total of 9 cycles of chemotherapy were performed. The patient complained of priapism occurring about 15-hours (about 1: 00 of the next morning) after intravenous infusion of paclitaxel (albumin bound) in the cycles 1-5 and 7-9, which could disappear about 2 hours later. No special treatment was given. After that, paclitaxel for injection (albumin bound) was not used, and the patient did not have the above symptoms again after changing to immunotherapy as disease progresses. It was considered that the patient′s priapism might be related to paclitaxel for injection (albumin bound).
  • 中毒救治
    Xu Fengquan;Feng Xinghua
    . 2008, 10(6): 0-0.

    Strychni semen is the dried ripe seed of Strychnos nuxvomica L. The crude drug contains alkaloids, of which the main alkaloids are strychnine and brucine. Strychnine is the main toxic component of strychni semen. Generally, the oral intoxicating dose of strychnine in adults is 5~10 mg, and the oral lethal dose is 30 mg. Strychnine can cause excitation of all parts of the central nervous system. Early signs of intoxication are headache, dizziness, nausea, vomiting, anxiety, restlessness, and slight twitching. Generalized convulsion, increasing sensitivity of sense organs, trismus, risus sardonicus, opisthotonus, dysphagia, and dyspnea follow. The patients often die from respiratory arrest. The principle of therapy in strychni semen poisoning is the prevention or control of convulsions and asphyxia. Management includes gastric lavage, the administration of activated charcoal, sedation with diazepam or phenobarbital, respiration support, and symptomatic treatment. The following precautions should be taken for safe use of strychni semen: crude drug should not be used, and the dosage should conform to the dosage limit in Chinese Pharmacopoeia; strychni semen should not combine with some drugs such as spirit, poppy capsule, musk, and so on; strychni semen is contraindicated in pregnant women; strychni semen should be used with caution in patients with liver and renal function insufficiency, neurological disorders, hypertension, and heart disease; overuse and prolonged use of strychni semen should be avoided, otherwise careful monitoring should be performed; the dosage should be adjusted when using strychni semen from different producing area.

  • Zhang Zhicui, Han Zhenhua, Fang Fang, Li Jinchang, Cui Ping, Wei Min, Wang Jing
    Adverse Drug Reactions Journal. 2020, 22(5): 295-299. https://doi.org/10.3760/cma.j.cn114015-20181211-01232
    Objective To understand the occurrence of intraoperative memory (dream, halluci- nation, and intraoperative awareness) following anesthesia with propofol and sufentanil and analyze its influen- cing factors in patients undergoing painless curettage of the uterine cavity. Methods The modified Brice questionnaire survey results in patients who underwent painless curettage of the uterine cavity under propofol and sufentanil anesthesia in Shuangqiao Hospital from January 2017 to September 2018 were retrospectively analyzed. The memory of patients from anesthesia induction to consciousness recovery after anesthesia was evaluated, and the incidences of dream, hallucination (including sexual hallucination), and intraoperative awareness were calculated. The possible influencing factors (including age, weight, operation time, initial and total dose of propofol, and total dose of sufentanil) of intraoperative memory after anesthesia with propofol and sufentanil were analyzed using logistic regression method. Results A total of 2-142 patients were enrolled, aged (28.3±7.4) years and weighing (61.8±10.2) kg, with gestational age of (7.8±1.3) weeks and a median operation time of 5 (3-28) min; the initial dose of propofol was (94.1±20.9) mg, with a total dose of (110.0±39.8) mg; the total dose of sufentanil was (9.9±0.4) μg. Among the 2-142 patients, 1-038 (48.5%) had memory from anesthesia induction to consciousness recovery after anesthesia, 1-019 (98.2%) of which were defined as dreams, 19 (1.8%) as hallucinations, and no one had intraoperative awareness. Eleven of 1-038 patients were defined as having sexual hallucinations and the incidence was 0.5%. There was no significant correlation between the occurrence of intraoperative memory and age, weight, operation time, initial dose and total dose of propofol, and total dose of sufentanil (P>0.05 for all). Conclusion The anesthesia of propofol combined with sufentanil may lead to dreams and hallucinations in patients undergoing painless curettage of the uterine cavity, and occurrence of sexual hallucinations should be more paid attention to.
  • 综述
    . 2000, 2(1): 6-14.
    随着现代医药的发展及治疗的需要,使绝大多数患者几乎都存在多药并用状况,从而药物相互作用所致的不良反应也日趋严重,已成为处方医师和服药患者必须认真考虑的一个重要而又现实的问题。其中,以前知之甚少的药物代谢性相互作用更是人们关注的热点。本文旨在对此问题的研究进展作一概要介绍,以期引起有关方面和医务人员的重视,及早采取措施,将药物因代谢性相互作用引致的不良反应减少到最低限度。
  • Li Zuojun, Su Yanhong, Zhou Yulu, Wu Cuifang, Wang Chunjiang
    Adverse Drug Reactions Journal. 2022, 24(5): 246-251. https://doi.org/10.3760/cma.j.cn114015-20210407-00431
    Objective To understand the clinical characteristics of risperidone-induced rhabdomyolysis (RM). Methods Risperidone-related RM case reports were collected by searching relevant databases at home and abroad as of February 2021, and the patients′ general conditions, disease conditions, medication use, RM occurrence [time of occurrence, clinical symptoms, and serum creatine kinase (CK) level, etc.], and treatment and outcome were recorded and descriptively analyzed. Results A total of 16 patients were collected, including 14 males and 2 females, with age of 13-76 years. The primary diseases were schizophrenia in 11 patients, psychomotor agitation, obsessive-compulsive disorder, depressive syndrome with psychotic symptoms, depressive symptom cluster, and suspected psychotic symptoms in 1 case each. Among the 16 patients, 2 were treated with risperidone alone, and 14 were treated with risperidone combined with other drugs (6, 6, 5, 4, 3, and 1 with other antipsychotics, sedatives, antidepressants, statins, anticho- linergics, and cyclosporine, respectively, and 3, 7, 1, and 3 cases with 1, 2, 3, and 4 combination drugs, respectively). Except that the medication method was not described in 2 cases, risperidone was orally adminis- tered in 13 cases and injected in 1 case. Thirteen patients with oral risperidone had dosage descriptions, of which 12 cases′ dose met the requirements of the drug labels, and 1 case took risperidone 96-mg due to severe hallucinations induced by drug withdrawal after taking the drug with routine dose for 5 years. In addition to the patient with overdose of risperidone, the occurrence time of RM was described in 14 cases, which was 4 days to 2 years after risperidone, and 10 cases occurred within 4 to 15 days after risperidone use. The main clinical symptoms were muscle pain (10 cases), acute liver injury (8 cases), acute kidney injury (5 cases), muscle weakness (4 cases), fever (3 cases), tachycardia (3 cases), and acute tendon intermembrane space syndrome (3 cases). The CK level was 4-587 to 928-961-U/L with a median level of 27-355-U/L in the 16 patients with RM, and it was>15-000-U/L in 10 cases (62.5%). After RM occurred, risperidone was discontinued in 13 patients, continued in 2 patients, and used at reduced dose in 1 patient; 8 patients received hydration therapy, 3 received hemodialysis, 1 received organ support therapy, and 3 with acute compartment syndrome (ACS) were treated with fasciotomy. All 16 patients′ symptoms disappeared and CK levels returned to normal. Among them, the specific time of recovery were described in 12 patients. The time of symptom disappea- rance was 2-12 months and the time of CK level recovery was 7-56 days. Conclusions Risperidone-related RM mostly occurs within 4-15 days after exposure to risperidone, which is mostly related to the combination with other drugs. The elevation of CK level is usually severe, which can be complicated by ACS. Symptoms could return to normal after risperidone was discontinued and/or symptomatic treatments are given.
  • Wang Han, Tian Chunxiang, Ning Ping, Li Gen, Liang Hua
    Adverse Drug Reactions Journal. 2020, 22(8): 466-470. https://doi.org/10.3760/cma.j.cn114015-20191219-01039
    Objective To explore the clinical characteristics of granulomatous mastitis (GM)induced by antipsychotics. Methods Antipsychotic-related GM cases were collected in Chengdu Women′s and Children′s Central Hospital. Meanwhile, antipsychotic-related GM literature cases in PubMed, Embase, ScienceDirect, Wanfang, VIP, and CNKI databases up to November 2019 were searched. The age, fertility status, primary mental disease, causative agents, duration of medication, diagnosis and characteristics of breast lumps, serum prolactin level, intervention measures, and prognosis of these patients were collected and analyzed retrospectively. Results A total of 7 clinical patients and 9 literature cases with antipsychotic drug-related GM were collected, and all of them were female, aged 21-55 years, of which 10 patients were never giving birth. They took antipsychotics for 0.5-17.0 years. The causative drugs included risperidone in 8 of the 16 patients. Other antipsychotics included olanzapine, clozapine, sulpiride, aripiprazole, perphenazine, quetiapine, amisulpride, flupentixol and melitracen, and etc. Serum prolactin levels elevated in 12 patients (25.45-84.50-μg/L), were normal in 3 patients, and were not mentioned in 1 patient. Surgical resection was performed in 9 patients. GM were improved significantly in the remaining 7 patients with or without adjusting antipsychotics after receiving oral administration of bromocriptine and/or methylprednisolone. And GM recurred in 1 patient during the followed-up. Conclusion Antipsychotic-related GM may occur in women of any age, regardless of whether they have giving birth. Risperidone is the main antipsychotic drug causing GM.
  • Jiang Shuai, Cai Haodong, Dong Mei
    Adverse Drug Reactions Journal. 2020, 22(4): 217-220. https://doi.org/10.3760/cma.j.cn114015-20200225-00169
    With the continuous deepening of the research on tumor pathogenesis, more and more innovative oncology drugs have been approved on the market, mainly including targeted antitumor drugs and immune checkpoint inhibitors. These new antitumor drugs have the advantages of high specificity, precise targeting, good efficacy, and low toxicity to greatly improve the patient quality of life and prognosis. However, because of the different types and monitoring methods of their adverse drug reactions from those of the traditional chemotherapy ones, the research on these drugs from aspects of prediction of adverse drug reactions, the relationship between adverse drug reactions and gene polymorphisms, and the therapeutic drug monito- ring are still necessary to be further researched.
  • 调查研究
    Ma Jianli;Zhao Liang;Wang Shiling
    . 2000, 2(3): 166-168.
    Objective: To analyse the cases with allergic shock induced by traditional Chinese medicines for rational use of the drugs. Methods: Reports of 131 cases with allergic shock published at home during 1989-1999 were collected and the way of drug administration, dosage forms and some other aspects were sorted out and investigated. Results: Injection came first in order of the cause of allergic shock (72.52%) followed by per os (16.03 % ) , preparation for external use only (2.29% ) and others (9.16% ) . Conclusion: The rational use of the drugs with a close attention during its continuation was recommended.
  • 调查研究
    Su Hao;Li Guangxi;Li Hui
    . 2003, 5(5): 297-301.
    Objective:To observe the effect of ribavirin on hemoglobin(Hb )of SARS patients.Method:Hb changes were detected in57SARS patients around the period of ribavirin administration.Results:Estimation of Hb levels showed signifi-cant difference between before and after the start of treating(P<0.05).Hb drop was associated with daily dosage of ribavirin(P<0.05),not with its cumulative action and teatment duration.Con clusion:Ribavirin of lower dose daily is recommended in clinical practice of anti-SARS so as to avoid its adverse effects on Hb.
  • Shen Shan, Jiang Na, Li Weizhe, Zhang Wen, Lu Cuicui
    Adverse Drug Reactions Journal. 2021, 23(5): 277-278. https://doi.org/10.3760/cma.j.cn114015-20201025-01082
    A 64-year-old male patient with type 2 diabetes mellitus received metformin 0.5 g thrice daily, acarbose 100-mg thrice daily, and saxagliptin 5-mg once daily orally. The patient developed itching and erythema symptoms during the treatments. The patient learned that metformin could cause adverse reactions such as pruritus and rash by reading the drug label. Then the metformin was stopped by himself and his skin symptoms were relieved within a few days. Due to elevated blood glucose, the patient took metformin again and developed erythema and papules 2 days later, but he didn′t stop the drug. After that, swelling of both lower limbs, accompanied by skin erosion and exudation appeared gradually. Laboratory tests showed that eosinophil count was 0.66×109/L. Drug eruptions caused by metformin was considered. All oral hypoglycemic drugs were stopped and symptomatic treatments such as antihistamine and glucocorticoid were given. Five days later, his erythema and papules gradually subsided, and erosive surface of both lower limbs crusted without exudation. Laboratory tests showed eosinophil count 0.06×109/L. Dermatitis did not recur after the patient switched to insulin to control blood glucose.
  • 调查研究
    Yan Jinsong*;Guo Ping
    . 2003, 5(2): 81-83.
    Objective;To observe the side-effects of thalidomide used for multiple myeloma. Method:Thalidomide-induced unwanted effects were analysed in 32 inpatients with multiple myeloma. Results; The occurrence rate of adverse reactions was 94% in all, 87.5% in alimentary system, 84.4% in neuropsychic system,and the others included sinus bradycardia, escape rhythm, drug fever, skin rashes, edema, etc. Conclusion; Thalidomide could cause gastro-intestinal and neuropsychic disturbances, which would disappear or relieve with discontinuation of administration or reduction of dose.
  • Pan Shoudong, Wang Tianlong
    Adverse Drug Reactions Journal. 2023, 25(6): 321-323. https://doi.org/10.3760/cma.j.cn114015-20230420-00289
    The incidence of pediatric anesthesia emergence delirium (ED) is high, and the potential harm is significant. It can be diagnosed through the pediatric anesthesia emergence delirium scale (PAED). The risk factors of pediatric anesthesia ED include personal, surgical, and anesthetic factors. The anesthesia ED in children can be effectively prevented by relieving preoperative anxiety, optimizing anesthetic strategies, and providing effective postoperative analgesia. Alpha 2 agonists (eg. dexmedetomidine), opioids (eg. fentanyl), propofol, and ketamine have both preventive and therapeutic effects on anesthesia ED in children.
    【Key-words】 Delirium; Child; Anesthesia; Risk factors
  • Adverse Drug Reactions Journal. 2020, 22(10): 607-608. https://doi.org/10.3760/cma.j.cn114015-20201008-01011
  • 综合报道
    . 2002, 4(3): 163-166.
    本文根据近年来国内外有关呋塞米的不良反应的文献报道,概述了呋塞米的少见不良反应,有些不良反应比较严重,应予以重视。
  • Liang Xiao, Shen Shan, Wei Duncan, Zhang Yahui, Zhang Wen, Lu Cuicui
    Adverse Drug Reactions Journal. 2022, 24(8): 429-434. https://doi.org/10.3760/cma.j.cn114015-20220119-00055
    Objective To know the clinical characteristics of liver injury related to levetiracetam (LEV). Methods The relevant databases at home and abroad (up to August 31st, 2021) were searched and the case reports on LEV-associated liver injury were collected. Clinical information including patients′ basic characteristics, LEV application, concomitant medication, and occurrence, treatment, and outcome of liver injury, etc. were collected and analyzed by descriptive statistical method. Results A total of 17 patients were enrolled in the study, including 9 males and 8 females, aged from 1 month to 76 years with an average age of 35 years. The primary disease was idiopathic epilepsy in 7 patients and secondary epilepsy in 10 patients. Five cases had comorbidities. Thirteen patients had drug dosage records, all of which were within the range recommended in the labels; 13 patients had concomitant medication. The time from LEV treatment to the occurrence of liver injury ranged from several hours to 5 months in 17 patients and it was ≤2 months in 14 patients. The classification of liver injury was hepatocellular type in 7 patients, cholestasis type in 1 patient, mixed type in 1 patient, and unable to be determined due to lack of relevant data in 8 patients. Clinical symptoms were recorded in 10 patients, including yellowish skin and sclera in 5 cases, fever in 4 cases, nausea in 2 cases, vomiting in 2 cases, and biliuria in 2 cases. LEV was discontinued in 14 patients, 4 of whom did not received other interventions and the liver function was improved or returned to normal 2 to 20 days after drug withdrawal; LEV was replaced with other antiepileptic drugs and/or sympto- matic treatments in 10 patients, 9 patients′ liver function were improved or returned to normal (the recovery time was 5-37 days in 5 patients and not recorded in 4 patients), 1 patient had normal liver function after liver transplantation, but the liver injury recurred after LEV use again and was improved after drug withdrawal. Two patients did not stop LEV, one underwent liver transplantation due to liver failure and hepatic encephalopathy, and the prognosis was unknown; the other one developed fulminant liver failure and died. One patient had no record of whether or not stopping LEV, and the liver function returned to normal after artificial liver support treatment. Conclusions LEV-related liver injury mostly occurred within 2 months after drug administration. The clinical manifestations were similar to the liver injury caused by other drugs. Liver function usually was improved or returned to normal after the drug withdrawal. The patients who did not stop LEV had poor prognosis, and severe cases could lead to liver failure or death.
  • 药源性疾病
    Zhang Xiaoshu;Yu Aihe;Geng Yulan
    . 2007, 9(3): 195-200.
    The serotonin syndrome is a potentially life-threatening adverse reactions that results from therapeutic drug use. The mechanisms are attributed to the increase on activity of serotonergic system because 5-hydroxytryptamine (5-HT) accumulates in nervous system and 5-HT postsynaptic receptors are overactivated. The clinical feature is described as a clinical triad of mental-status changes, autonomic hyperactivity, and neuromuscular abnormalities. The syndrome often occurs in coadminstration among antidepressants or combination with other drugs. The diagnosis of the serotonin syndrome is mainly based on the clinical manifestation. Management of the serotonin syndrome involves the cessation of precipitating drugs, improvement of monitoring, control of agitation, administration of 5-HT antagonists, symptomatic treatment, the control of complication, etc. The prevention of the syndrome is more important than the treatment.
  • 药源性疾病
    SUN Zhen-xiao;YU Xiang-fen
    . 2012, 14(3): 154-6.
    Hyperprolactinemia is a common adverse effect of antipsychotic drugs. The clinical presentations of hyperprolactinemia are gynecomastia in men, and breast distending pain, galactorrhea, menstrual disturbance, sexual dysfunction, osteoporosis, and metabolic disturbance in women. The incidence of hyperprolactinemia is 25%-89%. The factors related to antipsychotic-induced hyperprolactinemia are gender, age, the type of antipsychotic drugs and dosage. The mechanism of antipsychotic-induced hyperprolactinemia may be related to blockade of dopamine D2 receptors on the anterior pituitary by antipsychotic drugs and reduction of dopamine inhibitory effect on prolactin secretion of prolactin cells, leading to prolactin elevation. Antipsychotic-induced hyperprolactinemia should be distinguished from hyperprolactinemia due to severe stress, depressive state, pregnancy, hypothyroidism, renal failure, pituitary tumor and ovarian disease. The treatment of antipsychotic-induced hyperprolactinemia includes discontinuing antipsychotic drugs, reducing antipsychotic drugs dosage, switching to a prolactin-sparing agent, prescribing a dopamine receptor agonist or Chinese herbal medicines, and using low-frequency repetitive transcranial magnetic stimulation.
  • Wang Liyan, Chen Yanwei, Li Yunming
    Adverse Drug Reactions Journal. 2020, 22(11): 650-651. https://doi.org/10.3760/cma.j.cn114015-20200203-00077
    A 55-year-old male patient with severe mitral valve insufficiency received long-time warfarin anticoagulation therapy after mechanical mitral valve replacement and the international standard ratio (INR) was 2.00-3.00. Because of oral ulcers, he took the water soaked with dandelion (Taraxacum mongolicum Hand-Mass.), which was self-purchased and sun-dried, for daily drinking. Fifteen days later, the patient developed chest tightness, shortness of breath, palpitation, and fatigue, followed by nausea, vomiting, mild edema of the lower limbs, orthopnea at night, ecchymosis on the right lower limb, and black stool successively. Laboratory tests showed hemoglobin 52-g/L, red blood cell count 2.05×1012/L. Gastrointestinal bleeding was considered, which might be related to the water soaked with dandelion drunk during warfarin therapy. Warfarin and water soaked with dandelion were stopped. The patient received symptomatic treatments including IV infusions of leukocyte-depleted red blood cell suspension 2 units (2 times in total) and esomeprazole 80-mg (twice daily), an intramuscular injection of vitamin K1-10-mg, and oral vitamin K1-20-mg. Two days later, the patient′s INR was 1.58, hemoglobin was 84-g/L, and red blood cell count was 2.33×1012/L. Five days later, his INR was 1.63, hemoglobin was 104-g/L, and red blood cell count was 3.92×1012/L.
  • Zhang Shaonan, Huang xiaohui, Yue Huijie
    Adverse Drug Reactions Journal. 2020, 22(1): 38-41. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.01.008
    Polymyxin B is mainly used in the treatment of severe drug-resistant gram-negative bacterial infection. In recent years, more and more cases of skin pigmentation caused by polymyxin B have been reported. The incidence of polymyxin B-related skin pigmentation in infants was higher than that in adults. The mechanism of polymyxin B-induced hyperpigmentation is not clear, which may be related to histamine release, skin inflammation, and the stimulation of melanin synthesis induced by polymyxin B. Although skin pigmentation has no significant effect on the treatment and prognosis in patients, it may cause psychological burden and affect the life quality, which should be paid more attention to and further studied.
  • Yang Xinliang, Ou Wei, Xie Xiaohua, Chen Yejun
    Adverse Drug Reactions Journal. 2023, 25(9): 570-572. https://doi.org/10.3760/cma.j.cn114015-20221011-00936
    A 73-year-old male patient was treated with tacrolimus 2.5-mg twice daily combined with prednisone 5-mg once daily orally for anti-rejection after lung transplantation. Due to pulmonary aspergillus fumigatus infection, the patient received voriconazole 400-mg orally twice daily on the first day and then 200-mg twice daily from the next day. During this period, the patient continued to receive anti- rejection treatments. Three days after the application of voriconazole, the patient developed decreased urine output and fatigue, serum creatinine was 196-μmol/L, and tacrolimus trough concentration was 49.0-μg/L. Acute kidney injury caused by tacrolimus poisoning was considered. Under the monitoring of blood drug concentration, tacrolimus was discontinued intermittently for 3 days, then tacrolimus was reduced to 0.5-mg once daily and voriconazole was reduced to 150-mg twice daily. Seventeen days later, the patient had a 24- hour urine output of 950-ml, serum creatinine of 154-μmol/L, and tacrolimus trough concentration of 7.7-μg/L. Twenty-two days later, his serum creatinine decreased to 142-μmol/L. It was considered that the abnormal increase of tacrolimus blood trough concentration was related to the inhibited metabolism after combined use with voriconazole.
  • Li Huan, Ding Yunlan, Zhai Qing
    Adverse Drug Reactions Journal. 2022, 24(2): 57-60. https://doi.org/10.3760/cma.j.cn114015-20220120-00064
    With the wide use of immune checkpoint inhibitors (ICI), its adverse reactions have attracted more and more attention. Due to their short time on the market, the data of ICI-related adverse reactions in Chinese population are not sufficient, so attention should be paid to the field. At present, the problems existing in adverse reaction monitoring of ICI include insufficient in-hospital monitoring, insufficient out-of-hospital monitoring, lack of monitoring research in special population, and lack of in-depth research on mechanisms and prediction indicators of ICI adverse reaction. In view of the existing problems, medical institutions should strengthen the monitoring and management of adverse reactions of ICI in hospitals, and enhance the management of special drugs such as ICI in social pharmacies. The monitoring data of adverse reactions of ICI can be further supplemented and improved through literature analysis, adverse reaction signal mining and analysis, real-world study and so on.
  • Pan Min, Fan Zhengda, Xue Jianrong, Hu Zhibang, Ma Jing
    Adverse Drug Reactions Journal. 2021, 23(4): 190-195. https://doi.org/10.3760/cma.j.cn114015-20200813-00868
    Objective To understand the occurrence of systemic adverse reactions in patients with simple allergic rhinitis (AR) after receiving subcutaneous immunotherapy (SCIT) with standardized dicid allergen injection. Methods The clinical data of AR patients who completed the whole course of SCIT with standardized mite allergen injection in AR Diagnosis and Treatment Center in Department of Otolaryngology, the Third People′s Hospital of Changzhou from August 1st, 2015 to July 31st, 2020 were analyzed retrospectively. The course of SCIT was 156 weeks, comprising 4 stages. The first 14 weeks was the dose increase phase, in which standardized mite allergen injection was given once a week and the dose was gradually increased from 5 TU in the 1st week to 5-000 TU in the 14th week; the weeks 15-52, 53-104, and 105-156 were the dose maintenance phase, in which the injection was given once every 5 weeks at the dose of 5-000 TU. According to the number of injections, the incidence of systemic adverse reactions in patients of different gender and age at different stages of the course of treatment and after injection at different doses were counted, and the types [according to the time of occurrence, the adverse reactions were divided into immediate type(≤30-min) and delayed type(>30-min)], classification (grade 1-5), clinical manifestations, and outcome of adverse reactions were analyzed. Results A total of 302 patients were enrolled in the study, including 175 males and 127 females, aged from 5 to 60 years. Of them, 187 patients were ≤14 years old and 115 were>14 years old. Three hundred and two patients received 13-687-subcutaneous injections totally and 46 patients in 120 times of injection had systemic adverse reactions. The incidence of adverse reactions was 15.23% (46/302) according to the number of cases and 0.88%(120/13 687) according to the number of injections. Among the 120 times of systemic adverse reactions, 55 (45.83%) were immediate type and 65 (54.17%) were delayed type. The adverse reactions belonged to grade 1 in 94 times of injections (78.33%, mainly manifested as nasal itching, eye itching, cough, pruritus, etc), grade 2 in 23 times of injections (19.17%, mainly manifested as asthma, diarrhea, etc), and grade 3 in 3 times of injections (2.50%, 2 mainly manifested as no response to inhaled bronchodilator and 1 as laryngeal edema). There was no significant difference in the incidences of systemic adverse reactions between the male and female patients [0.94% (76/8-091) vs. 0.79% (44/5-596), χ2=0.89, P=0.35]. The incidence of systemic adverse reactions in patients ≤14 years old was higher than that in patients >14 years old [1.14% (97/8-536) vs. 0.45% (23/5-151), χ2=17.59, P<0.01]. The incidence of systemic adverse reactions in weeks 16-52 [1.86%(40/2-153)] was higher than those in the first 14 weeks [0.99% (51/5-169)], weeks 53-104 [0.72% (23/3-194)], and weeks 105-156 [0.19% (6/3-171)], and the differences were statistically significant (χ2=9.40, P<0.01; χ2=14.30, P<0.01; χ2=41.69, P<0.01). The incidence of systemic adverse reactions at the injection dose of <5-000 TU was higher than that at the injection dose of 5-000 TU [1.11%(51/4-579) vs. 0.76%(69/9-108),χ2=4.45,P=0.04]. The systemic adverse reactions were self-relieved or could be relieved after the intervention and the outcome was good. Conclusions The incidence of systemic adverse reactions in AR patients who completed the whole course of SCIT with standardized dicid allergen injection was 0.88%, which mainly belonged to grade 1 adverse reactions. Children of ≤14 years old, during the week 16 to 52 of treatment, at the injection dose of <5-000 TU were more likely to have systemic adverse reactions.
  • 调查研究
    Feng Yanshuang
    . 2002, 4(2): 81-83.
    Objective: To analyze allergic reactions caused by traditional Chinese medicines statistically. Method: 187 ADRs were collected from national medical journals of 1999-2001 in consideration of gender, age, time, route and clinical manifastations. Results: ADR of traditional Chinese medicines was in no relation with gender and age of patients. But it was connected with route of administration. Drugs for injection ranked first on the ADR list, accounting for 109 cases. The time of ADR occurrence ranged from three minutes to seven days when drugs being taken, mostly in the period of treatment. Main manifestations of ADR were as follows: dermoreaction (122 cases), allergic shock (26), allergic rhinitis (7), allergic asthma (6), anaphylactoid purpura (5) and drug fever (17). Conclusion: Allergic reaction is the most common ADR and should be given close attention and prevented timely.
  • 综述
    . 2007, 9(1): 1-6.
    根据近年有关研究和报道对含马兜铃酸中药的毒性成分、马兜铃酸的代谢、马兜铃酸肾病的发病机制、临床特征及其诊断方法进行综述,旨在对马兜铃酸的毒理学及马兜铃酸肾病的诊治加深认识。
  • Lu Hong, Liu Fangqun, Zhao Chaohui, Zhang Hengbei
    Adverse Drug Reactions Journal. 2022, 24(6): 324-326. https://doi.org/10.3760/cma.j.cn114015-20210901-00952
    A 73-year-old male patient was given intravenous infusion of ketorolac tromethamine injection 60-mg diluted in 0.9% sodium chloride injection 250-ml once daily for gouty arthritis. At about half of the third infusion, he developed dull pain in the stomach, but did not pay much attention to it. Then vomiting (with blood in the vomitus) and melena accompanied by epigastric discomfort occurred later. The symptoms were considered to be related to ketorolac tromethamine injection, the drug was stopped, and the patient′s condition was observed. But the above symptoms continued and worsened, and palpitation, dizziness, fatigue, hematemesis, fresh blood on defecation, syncope, etc. occurred. The patient′s blood pressure was 58/33-mmHg and hemoglobin was 92-g/L. Gastroscopy and pathological examination showed multiple ulcers in antrum and the angle of the stomach, chronic superficial and erosive gastritis, duodenal bulbar inflammation, and Helicobacter pylori (+). The patients were diagnosed with peptic ulcer and hemor- rhagic shock. Norepinephrine, somatostatin, esomeprazole, and nutritional and supportive treatments were given, and 2 weeks later, the patient gradually recovered and the fecal occult blood was negative.
  • Wen Zhiyong, Guo Jiahao, Yang Xueming, Li Xueqin, He Yu, Ji Bo, Sun Yinxiang, Lu Hongyun, Wen Fangfang, Wang Guifeng, Wu Weipei, Zhou Zhiling
    Adverse Drug Reactions Journal. 2023, 25(3): 138-144. https://doi.org/10.3760/cma.j.cn114015-20221109-01041
    Objective To compare the efficacy and safety of vildagliptin tablets (the generic drug) manufactured by Qilu Pharmaceutical Co., Ltd. and vildagliptin tablets (the original drug) manufactured by Novartis Pharmaceutical Co., Ltd. in the treatment of type 2 diabetes mellitus (T2DM) in third round of national centralized volume-based procurement. Methods The study design was a multicenter retrospective cohort study. The study subjects were T2DM patients treated with vildagliptin tablets at the Outpatient Department of Zhuhai People′s Hospital, Zhongshan City People′s Hospital, Jiangmen Central Hospital, and General Hospital of Southern Theater Command of PLA from January 2020 to December 2021. Using the hospital electronic medical record system, medical records in outpatients who met the inclusion criteria were collected, and relevant clinical data were extracted. The patients were divided into generic drug group and original drug group. To exclude the interference of confounding factors, the propensity score matching method was used. The efficacy evaluation index was the magnitude of hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reductions within one year after administration. Generalized linear regression model was used to analyze the influencing factors for the magnitude of HbA1c and FPG reduction. The safety evaluation index was the incidence of adverse events within one year of drug use. Results A total of 4-511 patients with T2DM who were treated with vildagliptin tablets were collected from 4 hospitals, including 3-039 in the generic drug group and 1-472 in the original drug group. After treatment, the HbA1c and FPG in patients of the 2 groups decreased compared with those before treatment. The magnitude of HbA1c and FPG reductions in patients of the generic drug group were not significantly different from those in the original drug group [0.50 (0.05, 2.30)% vs. 0.90 (-0.10, 1.70)%, Z=0.235, P=0.814; 0.59 (-0.40, 2.20) mmol/L vs. 1.00 (-0.61, 2.32) mmol/L, Z=0.421, P=0.674]. The results of generalized linear regression model analysis showed that the therapeutic drugs did not affect the magnitude of HbA1c and FPG reductions (P=0.627, P=0.478). Compared with the original drug group, the incidences of adverse events and hypoglycemia in the generic drug group were not statistically significant [1.6‰ (5/3-039) vs. 2.7‰ (4/1-472), P=0.721; 0.7 ‰ (2/3-039) vs. 0.7 ‰ (1/1-472), P=1.000]. Conclusion The efficacy and safety of generic vildagliptin tablets manufactured by Qilu Pharmaceutical Co., Ltd. were generally consistent with those of the original drug in the treatment of T2DM.
  • Jing Shan, Wang Xin, Yang Kexu, Liu Wenfang, Li Jing, Tan Li, Suo Wei, Lu Chunyan, Lin Yang
    Adverse Drug Reactions Journal. 2021, 23(3): 113-119. https://doi.org/10.3760/cma.j.cn114015-20201012-01039
    Objective To evaluate the postprandial bioequivalence of domestic and original glucosamine sulfate capsules in Chinese healthy volunteers. Methods The trial was a single-center, randomized, open-label, single-dose, 2-preparation, 3-sequence, 3-period, partially repeated crossover design. The trialed drugs were domestic glucosamine sulfate capsules Yisuojia (test preparation) and original glucosamine sulfate capsules Viartril- (reference preparation). Healthy subjects were randomly divided into 3 groups, each group took medicine in 3 periods, but the order of taking test preparation (T) and reference preparation (R) was different, which were TRR, RTR and RRT groups. The healthy volunteers in the TRR, RTR, and RRT groups received the trialed drugs orally 30-minutes after diet supply on day 1, 4, and 7, respectively. Peripheral venous blood samples 4-ml were collected at 1-2 hours after dinner the day before medication (baseline 1), within 60-minutes before medication (baseline 2), and 15, 30, 45, 60, 90, 120, and 150-minutes and 3, 4, 5, 6, 8, 10, 14, and 16-hours after medication, respectively. Plasma was collected after centrifugation, frozen, and stored. Liquid chromatography-tandem mass spectrometry was used for the determination of glucosamine concentrations in plasma samples and main pharmacokinetic parameters such as the area under the concentration-time curve(AUC), including areas from time zero (pre-dose) to the last measurable concentration (AUC0-t) and extrapolated to infinite time (AUC0-∞), and peak concentration (Cmax) were calculated. Because glucosamine was an endogenous substance in humans, the measured blood concentration of glucosamine was corrected by subtracting the baseline value before medication (the average of baseline 1 and baseline 2). The test and reference preparations were equivalent when the geometric mean ratios (GMR) and their 90% confidence intervals (CI) for AUC0-t, AUC0-∞, and Cmax all ranged from 0.800 to 1.250. Results A total of 30-healthy volunteers were enrolled in the study, including 20 males and 10 females, aged (31±7) years with a range of 18-45 years. Ten volunteers were included in each TRR, RTR, and RRT group. One volunteer fell off in the TRR group after the first period of medication and the remaining 29 volunteers completed the trial. The baseline uncorrected GMR (90%CI) of AUC0-t, AUC0-∞, and Cmax for the test and the reference preparations were 0.985 (0.941-1.031), 1.014 (0.961-1.070), and 0.937 (0.827-1.062), respectively; the baseline corrected GMR (90%CI) of AUC0-t, AUC0-∞, and Cmax of the test and the reference preparations were 0.977 (0.923-1.035), 0.976 (0.922-1.032), and 0.932 (0.817-1.063), respectively, which all fell within the equivalence range (0.800-1.250). During the trial, no adverse events related to the trialed drugs occurred in the 3 groups. Conclusion Domestic glucosamine sulfate capsules were bioequivalent to the original when taken after diet and had a good safety profile.
  • . 2016, 18(1): 4.
  • 调查研究
    Wang Decai;Zhang Jiguo
    . 2004, 6(6): 383-386.
    Objective: To investigate the the allergic shock induced by cephalosporins. Methods: Literature was retrieved from domestic medical journals 1990-2003,and 244 cases with allergic shock in 210 papers were collected and analysed. Results: Twelve cephalosporins were involved in 244 cases and 93.8% of them were caused by six cephalosporins, namely, cefazolin, cefotaxime, cephalexin, cefoperazone, ceftriaxone and cefradine. The patients with and without allergic history accounted for 24.6% and 30.3% respectively and the others were unknown in this respect. 78.7% of the cases occurred during first administration and 86.1% did within 20 minutes of drug start. The mortality rate was about 8.2%. Conclusion: Cephalosporins could result in allergic shock and much attention should be especially paid to the patients with allergic history.
  • Chen Zhe, Zheng Xizi, Zhou Qingqing, Li Guohui
    Adverse Drug Reactions Journal. 2024, 26(8): 449-453. https://doi.org/10.3760/cma.j.cn114015‑20240603‑00413
    Accumulation of drugs and its metabolites in the body occurs and risks of adverse drugreactions increase in renal insufficiency patients due to the renal function decline or delay of renal excretionand the pharmacokinetic changes related to the decline of renal function. Therefore, the dose of anticancerdrugs should be adjusted in tumor patients with renal dysfunction. The Japanese Society of Nephrology,JapanSociety of Clinical Oncology,Japanese Society ofMedical Oncology,and Japanese Society of Nephrologyand Pharmacotherapy have jointly formulated Clinical Practice Guidelines for Management of Kidney Injury During Anticancer Drug Therapy 2022, and specifically discusses the dose adjustment of anticancer drug forpatients with renal injury in the second chapter. This article focuses on the interpretation of the principle ofdrug dose adjustment for patients with renal insufficiency and suggestions for dose adjustment of platinumdrugs and fluorouracil drugs in this chapter.
  • Li Jia
    Adverse Drug Reactions Journal. 2021, 23(2): 83-90. https://doi.org/10.3760/cma.j.cn114015-20200607-00641
    Hepatitis C virus protease inhibitors (PIs) are one of the major categories that constitute directly acting antivirals (DAA) regimen in the treatment for hepatitis C. These drugs are mainly metabolized by liver cytochrome P450 and have potential hepatotoxicity. Population pharmacokinetic study data showed that the metabolism of PIs was slower in Asians than that in White/Caucasian subjects, and the results of clinical trials and real-world studies in Asians showed that these drugs had the risk of causing liver enzyme abnormalities and bilirubin elevations. Medical workers in our country should pay full attention to the potential risks of PIs in liver safety, and should not rely too much on safety data in Europe and America. The baseline liver disease severity should be accurately assessed before selecting the DAA regimen containing PIs and the risk of disease progression should be considered. PIs are contraindicated in patients with decompensated liver disease. For patients without cirrhosis or with compensated cirrhosis, the liver function should be closely monitored during the administration of PIs and the management of liver-related adverse events should be paid attention to.
  • Wang Bing, Wang Quan, Li Jinfeng, Zhang Yuan
    Adverse Drug Reactions Journal. 2020, 22(10): 593-594. https://doi.org/10.3760/cma.j.cn114015-20191223-01056
    A 70-year-old female patient received oral rivaroxaban (10-mg once daily), amiodarone hydrochloride (200-mg thrice daily at the beginning and 200-mg twice daily 8 days later), and isosorbide mononitrate sustained release tablets (30-mg once daily) after radiofrequency ablation of atrial fibrillation. After 5 days of treatments, the patient developed weakness of both legs, which was gradually aggravated. Fifteen days later, the patient presented with weakness of the limbs, limited lifting of arms, inability to hold objects with hands, and inability to stand on legs for a long time. Electromyogram showed peripheral nerve damage. Peripheral neuropathy caused by tumor, metabolism, immunity, and inflammation were excluded by auxiliary examination, and the peripheral neuropathy caused by amiodarone was considered. Amiodarone was discontinued and oral vitamin B1, vitamin B6, and mecobalamin, and an IV infusion of thioctic acid were given. Ten days later, the patient′s symptoms were improved obviously.
  • Wang Qi, Zhao Bin, Chen Miao
    Adverse Drug Reactions Journal. 2023, 25(10): 622-628. https://doi.org/10.3760/cma.j.cn114015-20230313-00182
    Porphyrias are a group of metabolic disorders caused by the accumulation of porphyrin and its precursor substances due to enzyme defects in heme biosynthesis. The use of porphyrinogenic drugs is the main inducement of severe acute porphyria attack (APA) in porphyria gene carriers. Delta-aminolevulinic acid synthase 1 (ALAS1) in the liver is the rate-limiting enzyme of heme biosynthesis chain, which is negatively regulated by the free heme pool in liver. The core mechanism of drug-triggered APA is that drugs induce increases of the transcription and synthesis of ALAS1 in the liver through various pathways, congenital enzyme defect becomes the rate-determining step in porphyria gene carriers, a large amount of porphyrin or precursor substances accumulate in the body due to the inability to convert them into hemoglobin, and thereby APA occurs. Predicting the porphyrogenicity of drugs according to clinical experience and the che- mical structure, action mechanism, cell and animal test data of drugs can provide guidance to APA use in clinic and reduce its medication risk. However, the accuracy of prediction needs to be verified by medication data in clinical practices, and the response to porphyrinogenic drugs in porphyria gene carriers also has significant variabilities. When prescribing for porphyria gene carriers, potential risks of drug-triggered porphyria should be highly vigilant about, and drugs selection should be carefully; the delay of the treatment of other diseases due to using drugs too cautiously also should be avoided.
  • Shen Jianghua, Yu Yahui, Song Haoxin, Chu Yanqi
    Adverse Drug Reactions Journal. 2020, 22(7): 432-434. https://doi.org/10.3760/cma.j.cn114015-20190121-00066
    An 83-year-old male patient received IV infusions of linezolid 600-mg once per 12-hours and imipenem and cilastatin sodium 1 g once per 8 hours for incisional wound infection after cervical spinal fusion. Three days later, imipenem and cilastatin sodium was stopped according to the drug sensitive test result and linezolid was continued. Two weeks after the use of linezolid, the patient developed dry mouth, and abnormal sensation of tongue; and 18 days later, he developed black tongue coating in the center of the tongue, which could not relieved after drinking a lot of water. After that, the tooth root blackened and the denture pigmented gradually. It was considered as black hairy tongue, which might be associated with linezolid. Linezolid was stopped and compound chlorhexidine gargle was given for gargling. Twelve days later, the patient′s tongue coating returned to normal, the symptoms of dry mouth and thirst disappeared, and the color of tooth root became lighter.
  • 国外信息
    . 2005, 7(2): 150-154.
  • 药物滥用
    . 2005, 7(6): 430-433.
  • Ji Liwei
    Adverse Drug Reactions Journal. 2021, 23(6): 281-284. https://doi.org/10.3760/cma.j.cn114015-20210515-00575
    Sodium-glucose transporter 2 inhibitors (SGLT2i) are novel oral hypoglycemic agents, which reduces blood glucose by inhibiting the reabsorption of glucose in the proximal convoluted tubule of the kidney and increasing the excretion of glucose to the urine. SGLT2i is effective in the treatment for diabetes mellitus, but there are also some safety problems. Diabetic ketoacidosis (DKA) is a serious adverse reaction of SGLT2i. SGLT2i could cause at least a 7-fold increase in developing DKA, approximately 70% of which are euglycemic DKA (euDKA). The risk factors for euDKA include insufficient insulin secretion cell reserve, type 1 diabetes mellitus, insulin reduction or discontinuation, hypovolemia, perioperative period, weight loss, and restricted feeding, etc. Because the increase of blood glucose in patients with euDKA is not obvious, the diagnosis is often delayed, so close attention should be paid to it. Safety medication training for SGLT2i should be strengthened to improve clinicians′ understanding of SGLT2i-related euDKA, so that they can strictly grasp the indications of medication and avoid the inducement of euDKA. Once euDKA occurs, clinicians can make early diagnosis and treatment. Pharmacists should be involved in the safety management of patients using SGLT2i to improve the safety in treatment.
  • . 2016, 18(2): 83.
  • Ren Yuanqin, Zhang Lin, Chen Juanjuan, Chu Wenjiao, Wang Chen, Cai Mingzhi
    Adverse Drug Reactions Journal. 2021, 23(1): 47-48. https://doi.org/10.3760/cma.j.cn114015-20200603-00623
    A 25-year-old female patient took Congrong Tongbian oral liquid 20-ml once daily by herself for constipation. After 3 months of intermittent medication, the patient gradually developed dark urine and yellowish skin and sclera, accompanied by nausea, vomiting, and decreased appetite; 4 months later, laboratory tests showed alanine aminotransferase (ALT) 1-359-U/L, aspartate aminotransferase (AST) 859-U/L, alkaline phosphatase (ALP) 160-U/L, total bilirubin (TBil) 131.5-μmol/L, and direct bilirubin (DBil) 99.3-μmol/L. Liver injury caused by Congrong Tongbian oral liquid was considered, then the drug was discontinued, and IV infusions of magnesium isoglycyrrhizinate injection 200-mg dissolved in 5% glucose injection 250-ml once daily and polyene phosphatidylcholine injection 20-ml dissolved in 5% glucose injection 250-ml once daily were given. After the above treatments, the patient′s symptoms were gradually improved. Two weeks later, the patient′s urine color was basically normal, gastrointestinal symptoms disappeared, and liver function showed ALT 137-U/L, AST 87-U/L, ALP 126-U/L, and TBil 34.9-μmol/L. At a 2-month follow-up, the patient′s liver function returned to normal. The patient′s liver injury was most likely related to the Polygonum multiflorum in Congrong Tongbian oral liquid.
  • Chi Weijin, Yang Junzheng, Chen Baihao, Chen Chuyi, He Qi, Chen Peng
    Adverse Drug Reactions Journal. 2023, 25(9): 564-569. https://doi.org/10.3760/cma.j.cn114015-20230505-00329
    Tenofovir dipivoxil fumarate (TDF) is a anti human immunodeficiency virus and hepatitis B virus drug, which is commonly used in clinic. The osteotoxicity of TDF has always been a key issue of clinical concern. The bone toxicity of TDF is related to hypophosphatemia secondary to renal tubular toxicity. At present, there are few systematic descriptions of bone metabolism changes caused by TDF. In this paper, the effects of TDF on bone metabolism are reviewed from 3 aspects: its effects on osteoblasts and osteoclasts, bone turnover, and bone structure and fracture.
  • 调查研究
    Huang Xiang;Li Jun;Zheng Lina;Li Yong
    . 2003, 5(2): 83-87.
    Objective;To evaluate the side-effects induced by clindamycin and its safety in clinical practice. Method:According to organ/system types recommended by WHO, the adverse reactions of clindamycin in 248 cases were classified. Results; 15 organs/systems were involved and the commonest ADRs were damages of skin and its appendages, digestive system, central and peripheral nervous system. Conclusion; Clindamycin should be used with caution in patients with a history of hypersensitivity. There is a potential danger of significant diarrhoea, hematuria and respiratory depression mainly because of drug interactions.
  • Wang Haizheng, Lin Xiaolan, Zhang Peng, Wang Yawei, Chen Wenqiang
    . 2015, 17(5): 353.
    ObjectiveTo understand the characteristics of medication errors (ME) of traditional Chinese medicine in elderly patientsMethodsME reports of traditional Chinese medicine in elderly patients which were collected from International Network for the Rational Use of Drugs (INRUD) from January 1st, 2013 to November 31st, 2014 were selected and analyzed. The major types of ME, persons who triggered the ME, triggering factor, category, and persons who detected the ME were analyzed descriptively.ResultsA total of 520 ME reports were collected from 23 hospitals. The number of ME on medication usage and dosage in ME types ranked first and accounted for 48.5% (252/520), the number of deployment errors ranked second and accounted for 19.8% (103/520). In terms of the persons  triggering the ME, the percentage of physicians and pharmacists were 70.0% (333/476) and 29.4% (140/476), respectively. Triggering factors of ME were lack of knowledge of traditional Chinese medicine [30.0% (114/380)] and similar names of different drugs [16.3% (62/380)]. Intermediate and primary titles of pharmacists in persons who detected ME accounted for 53.2% (271/509) and 37.5% (191/509), respectively. The ME belonging to category A, B, and C accounted for 16.0% (83/520), 68.5% (356/520), and 13.8% (72/520)], respectively and all these errors did not do harm to patients. The errors belonging to category D and E accounted for 1.5% (8/520) and 0.2% (1/520), respectively. ConclusionsIn elderly patients, the errors in usage and dosage of traditional Chinese medicine were main types of errors and most of the ME were mild and did not do harm to patients. The triggering factor of the ME were lack of knowledge of traditional Chinese medicines in physicians and pharmacists.
  • 安全用药
    . 2004, 6(6): 387-392.
    本文对近年国内外发生的草药药害事件、草药不良反应的相关报道以及各国管理部门对此采取的相关措施进行了综合介绍。提出应切实加强对中药安全用药知识的宣传普及和不良反应的监测;规范中成药的说明书;做好中药质量的规范化、标准化工作。另外,应注意合理应用中成药,避免因其不正确应用或滥用而出现危害,影响中医药在国际上的声誉。
  • Zhang Yiqun, Ju Changbin, Li Fang, Liu Rui, Cheng Yufeng
    Adverse Drug Reactions Journal. 2022, 24(5): 233-238. https://doi.org/10.3760/cma.j.cn114015-20211218-01275
    Objective To explore the occurrence and characteristics of adverse reactions related to bevacizumab (Bev) in treatment of non-small cell lung cancer (NSCLC). Methods The medical records of NSCLC patients treated with Bev in the Respiratory Department of Bozhou Hospital of Traditional Chinese Medicine from May 2019 to March 2021 were collected. Patients with Bev-related adverse reactions, which were judged by Naranjo scoring method, were selected. The relevant information in these patients was extracted from their medical records, and the occurrence and outcomes of the adverse reactions (incidence, time of occurrence, clinical manifestation, severity, etc.) were analyzed retrospectively. The dosing regimen of Bev was IV infusion of 7.5-mg/kg once per 21 days (1 cycle). Results A total of 142 patients were included in the analysis, and 17 (12.0%), 20 (14.1%), 51 (35.9%), 35 (24.6%), and 19 (13.4%) patients received 1, 2, 3, 4, and 5 cycles of Bev treatment, respectively. All patients were treated with combination regimen with traditional chemotherapy drugs, including pemetrexed in 10 patients (7.0%), pemetrexed+carboplatin in 41 patients (28.9%), and pemetrexed+cisplatin in 91 (64.1%) patients, respectively. Among the 142 patients, 49 (34.5%) had adverse reactions, which were classified as grade 1, 2, 3, and 4 in severity in 18, 19, 6, 6 patients respectively, and the incidence of serious adverse reactions (≥ grade 3) was 8.5% (12/142). The clinical manifestations of adverse reactions included hematologic injury in 12 patients (8.5%; grade 1 in 4 and grade 2 in 8 patients), hypertension in 11 patients (7.7%; grade 1 in 4, grade 2 in 3, grade 3 in 2, and grade 4 in 2 patients), skin injury in 8 patients (5.6%; grade 2 in 5 and grade 3 in 3 patients), bleeding events in 6 patients (4.2%; grade 1 in 3, grade 3 in 1, and grade 4 in 2 patients), gastrointestinal reaction in 6 patients (4.2%; grade 1 in 3 and grade 2 in 3 patients), proteinuria in 3 patients (2.1%, grade 1), pulmonary embolism in 1 patient (0.7%, grade 4), gastric perforation in 1 patient (0.7%, grade 4), and alopecia in 1 patient (0.7%, grade 1). Bev was not discontinued in 37 patients who developed grade 1-2 adverse events, and 25 of them were given symptomatic treatments. Patients with grade ≥3 adverse reactions stopped Bev and received symptomatic treatments. All patients recovered or were improved. Conclusions The common adverse reactions in Bev treatment for NSCLC include hematologic injury, hypertension, skin injury, bleeding events, gastrointestinal reaction, and proteinuria, most of which are of grade 1-2 in severity. Severe adverse effects such as pulmonary embolism and gastric perforation occurred occasionally. Patients with grade ≥ 3 adverse reactions have a good prognosis when Bev is discontinued and symptomatic treatments are given.
  • Yue Xiaolin, Wang Yawei, Wang Xin
    Adverse Drug Reactions Journal. 2021, 23(11): 592-596. https://doi.org/10.3760/cma.j.cn114015-20210906-00969
    After administration of coronavirus disease 2019 (COVID-19) mRNA vaccine (BNT162b2 vaccine of Pfizer/BioNTech incorporation and mRNA-1273 vaccine of Moderna incorporation), some vaccinators develop vaccination-associated lymphadenopathy (VAL). VAL usually occurs 2 to 4 days after vaccination, or 2 weeks later. The incidence of VAL after the second dose of vaccine is higher than that after the first dose. Some vaccinators develop VAL after both the first and second doses of vaccination. The clinical manifestations of VAL are enlarged lymph nodes with pain in axilla, supraclavicular, neck, and inguen on the same side of the inoculation site. Imaging examination shows enlarged lymph nodes with diffuse or focal cortical thickening, etc. The pathological diagnosis is benign reactive lymphadenopathy. VAL does not need treatment and generally subsides spontaneously 5 to 16 days after onset. The mechanism of lymphadenopathy after administration of COVID-19 mRNA vaccine is unclear.
  • Adverse Drug Reactions Journal. 2020, 22(3): 201-204. https://doi.org/10.3760/cma.j.cn114015-20200227-00148
    国家卫生健康委员会和国家中医药管理局发布的《新型冠状病毒肺炎诊疗方案(试行第六版)》指出,可试用磷酸氯喹进行抗病毒治疗。氯喹既往用于疟疾、肠外阿米巴病和类风湿关节炎等疾病的治疗,关于其不良反应已有较多报道。本文重点对氯喹相关严重不良反应以及急性中毒的临床表现和处理进行文献回顾,以期为临床安全使用氯喹提供借鉴和参考。
  • 安全用药
    Zeng Lingling;Zhou Guiqin
    . 2011, 13(1): 17-4.
    Drug-induced liver injury(DILI) is one of the common adverse drug reactions. Over 1100 drugs and related substances are associated with DILI. However, there is no specific diagnostic marker to DILI so far. This paper introduces and discusses some main diagnostic criterias in order to be helpful for diagnosis of DILI in clinical practice.
  • 药源性疾病
    Lei Zhaobao
    . 2009, 11(3): 191-5.
    The term of drug-induced taste disorders refers to agusia, dysgusia, and hypogusia due to drugs. More than one hundred drugs can cause taste disorders. The main drugs causing taste disorders are anti-infectives, cardiovascular drugs, drugs used in neuropsychopathy, and antineoplatics. One of the plausible mechanisms of druginduced taste disorders is the reduction of zinc concentration in human body. Drug-induced taste disorders can negatively influence appitite, food intake, quality of life, emtional state, and importantly, medication compliance. Therefore, doctors should care for the druginduced taste disorders occurring in clinical practice.
  • 安全用药
    . 2003, 5(2): 88-91.
    抗菌药物临床应用广泛,与其用药相关的药物不良反应近年来有增多趋势,其中急性肾衰竭,通常后果严重。导致急性肾衰竭的抗菌药物类别很多,近年最常见的是β-内酰胺类,其次为氨基糖苷类。抗菌药物导致的急性肾衰竭临床表现多样化,病理改变包括急性间质性肾炎和急性肾小管坏死,致病机制常与药物的变态反应性肾损害和直接肾毒性相关。注意监测易感人群、合理用药、对可疑病例及时处理可减少急性肾衰竭的发生。
  • Wang Yanling, Zhang Qingxia
    Adverse Drug Reactions Journal. 2022, 24(7): 341-346. https://doi.org/10.3760/cma.j.cn114015-20220310-00201
    Objective To understand and analyze the occurrence of medication error (ME) on warfarin and their related factors in order to avoid or reduce adverse events. Methods All ME reports in the National Monitoring Network for Clinical Safe Medication (monitoring network) from January 1, 2016 to December 31, 2020 were collected and warfarin ME reports were selected. The grading and contents of warfarin MEs, the persons who caused and found the errors, and the factors that triggered the errors were analyzed. Results During the set period, a total of 59-987 ME reports from 30-hospitals in 13 provinces and municipalities in China were collected in the monitoring network, which included 149 ME reports (0.3%) of warfarin, involving 149 patients. Among the 149 patients, 94 were male (63.1%) and 55 were female (36.9%), aged 2-87 years. The indications of warfarin were atrial fibrillation in 78 patients, mechanical valve replacement in 47 patients, thrombosis in 10 patients, pulmonary embolism in 10 patients, and congenital heart defect in 4 patients. One hundred and thirty-two MEs (88.6%) were mild and 17 (11.4%) were severe, of which 1 caused patient death. Among the warfarin MEs, dose errors ranked the first, accounting for 29.5% (44/149), followed by medication frequency error (26.2%, 39/149) and wrong drug class (22.2%, 33/149). Among the 149 MEs, 102 (68.5%) were triggered by doctors, 25 (16.8%) were by pharmacists, and 22 (14.8%) were by patients/family members. In the 102 MEs triggered by doctors, 94 were intercepted by pharmacists or nurses and 8 were not intercepted, which were all severe MEs [7 were drug selection errors (drugs were not selected based on drug interaction) and 1 were wrong dose]. In the 25 MEs triggered by pharmacists, 24 were intercepted by pharmacists, nurses, or patients/family members and 1 was not intercepted, which was dose error(severe); the patient involved in the severe ME was treated with combined anticoagulant therapy and no thromboembolic events occurred. In the 22 MEs caused by patients/family members, 14 were intercepted by doctors, nurses, or pharmacists and 8 were not intercepted, which were severe MEs, including 1 dose error (causing patient death), 2 frequency errors, and 5 drug class errors. A total of 132 MEs were found in time and successfully intercepted. Among the persons who found the MEs, 61 were pharmacists, accounting for 46.2%; 53 were nurses, accounting for 40.1%; 10 were doctors, accounting for 7.6%; 8 were patients/family members, accounting for 6.1%. The main factors causing MEs were lack of knowledge(accounting for 57.1%, 85/149), fatigue, misreading, and machine fault (accounting for 22.8%, 34/149), and unskilled technology (accounting for 13.4%, 20/149) in order. Conclusions In the content of warfarin MEs, dose error ranks the first, and drug class errors and drug selection errors usually cause severe MEs. Pharmacists play an important role in discovering and intercepting the warfarin MEs. Lack of knowledge is the primary factor causing MEs.
  • Liu Shengye, Gao Nianting, Wu Xin'an, Li Boxia
    Adverse Drug Reactions Journal. 2022, 24(11): 609-611. https://doi.org/10.3760/cma.j.cn114015-20220309-00194
    A 64-year-old male patient underwent diagnostic imaging of lower extremity venography plus inferior vena cava angiography due to deep vein thrombosis of lower extremity. Nadroparin calcium anticoagulation was given for 3 days before the operation, and heparin sodium anticoagulation was given after the operation. On the 3rd day of the operation, the coagulation function test showed fibrinogen (FIB) 2.78-g/L, activated partial thromboplastin time (APTT) 26.4-s. Continuous intravenous pumping of argatroban 1.5-μg/(kg·min)(22-hours daily) and intravenously pumping of urokinase 600-000 U (lasting 2 hours) were given. On the 4th day of operation, the coagulation function test showed FIB 0.1-g/L and APTT 94.7-s. Considering the possible relation to drugs, urokinase was stopped, the dose of argatroban was reduced to 1.0-μg/(kg·min), and human fibrinogen was added. On the 5th day of operation, the coagulation function test showed FIB 0.49-g/L and APTT 51.2-s, and argatroban was stopped. On the 8th day of operation, the coagulation function test showed FIB 1.30-g/L and APTT 31.8-s, and fresh frozen plasma 750-ml was given twice daily by intravenous infusion. On the 11th day of operation, the coagulation function test showed FIB 2.40-g/L and APTT 28.3-s.
  • Huang Shuohan, Wang Mengmeng, Ye Xuan, Guo Zihan, Shan Han, Zhai Qing, Liu Jiyong, Du Qiong
    Adverse Drug Reactions Journal. 2023, 25(5): 308-314. https://doi.org/10.3760/cma.j.cn114015-20221009-00925
    Dual target therapy of dabrafenib combined with trametinib (DabTram) plays an important role in the treatment of malignancies. Ocular toxicities are adverse reactions which are relatively uncommon but potentially serious in DabTram treatment. At present, there is a lack of systematic research on ocular toxicities caused by DabTram, leading to insufficient understanding of this problem. In this paper, the literature on DabTram-related ocular toxicities are systematically reviewed, especially focusing on the incidence, clinical characteristics, mechanisms of occurrence, therapeutic measures and so on, and the corresponding management pathways in clinical medication were proposed to provide references for safe use of DabTram in clinic.
  • Li Qin, Zhuo Ga, Jin Meiling, Ye Xiaofen
    Adverse Drug Reactions Journal. 2021, 23(6): 317-318. https://doi.org/10.3760/cma.j.cn114015-20201111-01126
    A 40-year-old female patient took ibuprofen dispersible tablets twice (0.4 g, 3-4 hours interval) by herself due to fever. One hour after the second medication, the patient developed nausea, vomiting, and small bleeding spots on skin. One day later, she developed yellowish skin and sclera. Three days later, her urine output decreased to 300-400-ml daily. Five days later, laboratory tests showed alanine aminotransferase (ALT) 3-531-U/L, aspartate aminotransferase (AST) 811-U/L, total bilirubin (TBil) 149.7-μmol/L, creatinine (Scr) 753-μmol/L, and uric acid (UA) 800-μmol/L. She was diagnosis as having severe liver injury and acute renal failure, which was considered to be associated with ibuprofen. After 6 days of treatments such as liver protection, continuous renal replacement therapy (CRRT), and fresh frozen plasma infusion, the patient′s yellowish skin and sclera were relieved and small bleeding points reduced. Laboratory tests showed ALT 513-U/L, AST 36-U/L, TBil 31.5-μmol/L, Scr 281-μmol/L, and UA 241-μmol/L. Her urine volume was 2-500-ml per day. After CRRT was stopped and liver-protective treatment was continued for 14 days, the yellowish skin subsided and the bleeding points disappeared. Laboratory tests showed ALT 55-U/L, AST 39-U/L, TBil 15.6-μmol/L, Scr 101-μmol/L, and UA 237-μmol/L, and her urine volume was 4-000-ml per day.
  • Adverse Drug Reactions Journal. 2020, 22(3): 211-214. https://doi.org/10.3760/cma.j.cn114015-20200214-00110
    口罩作为重要的防护品,在新型冠状病毒肺炎(COVID-19)疫情期间消耗极大。为了避免口罩的不合理使用,减少疾病传播,本文介绍了口罩的分类及评价其质量和性能的重要技术指标,包括过滤效率与通气阻力、佩戴的密合度和舒适度、气流阻力、合成血液穿透性、微生物指标等。
  • Wang Caiqin, Wang Wenli
    Adverse Drug Reactions Journal. 2020, 22(11): 660-661. https://doi.org/10.3760/cma.j.cn114015-20190527-00456
    A 62-year-old female patient with bladder cancer received intravesical instillation of pirarubicin hydrochloride for injection (pirarubicin) after operation (30-mg dissolved into 5% glucose injection 30-ml was injected into the bladder through a catheter, and the instillation fluid was retained for 40-minutes). No adverse reactions occurred in the first 12 times of instillation. Seven months after operation, when the 13th instillation was performed for about 30-min, the patient developed numbness of lips, hands, and feet, profuse sweating, generalized flush, loss of consciousness, incontinences of fecal and urine, undetectable blood pressure, and heart rate of 110 beats/min. Anaphylactic shock caused by pirarubicin was consi- dered. The bladder instillation fluid was drained immediately and treatments of anti-allergy, cardiotonic, and raising blood pressure were given. The patient′s blood pressure returned to 70/50-mmHg and consciousness recovered after 1 hour. Two and a half hours later, the patient developed systemic edema and rashes. Anti- allergy treatments were re-given. The rashes disappeared 3 days later and edema subsided 11 days later.
  • 综述
    . 2002, 4(1): 1-4.
    抗生素滥用现象已引起国内外的严重关注,本文综述了抗生素滥用的根源及促进抗生素合理使用的策略。抗生素滥用根源包括治疗从经验出发、对医生及患者缺乏有效的宣传教育、患者对抗生素不切实际的期望、经济因素等;促进抗生素合理使用的策略包括对医生处方进行干预、实施抗生素控制政策、采用计算机决策支持系统、对医护人员及患者进行抗生素合理使用的宣传教育、引入临床治疗指南、对医疗过程进行审核与反馈以及对特定人群进行疫苗接种等。抗生素的合理使用需要医生、药师、患者的通力协作,避免抗生素的滥用,减少耐药性产生的机会,最终提高抗生素使用的有效性。
  • Ji Chunmei, Huang Wen, Hu Yunzhen
    Adverse Drug Reactions Journal. 2021, 23(1): 39-40. https://doi.org/10.3760/cma.j.cn114015-20200424-00466
    A 32-year-old male patient received moxifloxacin hydrochloride 400-mg orally once daily for lung infection. Four days after medication, the patient developed dizziness, blurred vision, diplopia, etc. Head CT showed no abnormalities. These symptoms were considered to be related to moxifloxacin hydrochloride and the drug was discontinued. Three days later, his symptoms were not improved. Eye examination showed his pupils are equal, round, and sensitive to light; his left eyeball had abduction disorder and right eyeball had normal movement function. The patient had no facial paralysis or muscle abnormalities. Cranial magnetic resonance imaging and other auxiliary examinations showed no obvious abnormalities. Neurotrophic drugs such as mecobalamin, mouse nerve growth factor, and fursultiamine were given, and the patient′s symptoms were gradually improved. After 25 days of drug withdrawal, the patient′s symptoms completely disappeared.
  • Wang Juanjuan, Tian Jihua, Kang Jing, Yang Jia, Chang Sijia, Ji He, Huang Taiping, Fan Weiping, Guo Jinli, Wang Yanhong
    Adverse Drug Reactions Journal. 2021, 23(9): 461-467. https://doi.org/10.3760/cma.j.cn114015-20210322-00336
    Objective To explore the injury effect and its possible mechanism of amiodarone on human umbilical vein endothelial cells (HUVECs). Methods After 3 generations of cultivation, the HUVECs were seeded in 96-well plates and incubated with amiodarone (0, 10, 20, 30, and 60-μmol/L) for 24-hours. The cell viability was detected using cell counting kit 8 (CCK-8) assay and the relative viability of cells incubated with different concentrations of amiodarone were calculated by taking the cell viability of the 0 μmol/L group as 100%. The concentration of amiodarone at which cell viability was reduced to 70% was selected for subsequent experiments. The effect of amiodarone of this concentration on the activity of HUVECs after action for different time (6, 12, 24, 36, and 48-hours) was detected using the CCK-8 assay. HUVECs cultured with amiodarone of this concentration were set as the experimental groups and those without amiodarone were set as the control group. Apoptosis rate of HUVECs was detected by Annexin V-FITC/P flow cytometry; the protein and mRNA expression levels of B-cell lymphoma 2 (Bcl-2), Bcl-2-associated X protein (Bax), Caspase-3, interleukin 10 (IL-10), IL-1β, IL-6, and tumor necrosis factor alpha (TNF-α) were detected using western blotting and real-time fluorescence quantitative polymerase chain reaction, respectively; the reactive oxygen species (ROS) was detected by DCFH-DA fluorescence probe assay; the superoxide dismutase (SOD) activity was detected by water-soluble tetrazolium-1 assay; the reduced glutathione (GSH) content was detected by microplate assay. Results The viabilities of HUVECs incubated with amiodarone at concentration of 10, 20, 30, and 60-μmol/L for 24-hours were (88.82±2.64)%, (74.96±1.75)%, (64.95±2.10)%, and (18.57±0.65)%, respectively; differences were all significant (all P<0.01) between each experiment group and control group, as well as between each experiment group. Amiodarone at a concentration of 30-μmol/L was used for subsequent experiments. After incubating with 30-μmol/L amiodarone for 6, 12, 24, 36, and 48-hours, the viabilities of HUVECs were (90.19±1.88)%, (82.81±2.51)%, (75.33±1.37)%, (65.76±1.85)%, and (47.01±3.29)%, respectively; differences were all significant (all P<0.01) between each experiment group and control group, as well as between each experiment group. Compared with the control group, the apoptosis rate of cells in the experimental group was significantly higher (48.59% vs. 16.34%, P<0.01), the protein and mRNA expression levels of pro-apoptotic proteins Bax and caspase-3, and pro-inflammatory factors IL-1β, IL-6, and TNF-α were higher (all P<0.01), whereas the protein and mRNA expression levels of anti-apoptotic protein Bcl-2 and anti-inflammatory factor IL-10 were lower (P<0.05, P<0.01). Conclusions Amiodarone can cause HUVECs injury, which would be enhanced with the increase of concentration and action time of amiodarone. Amiodarone may cause HUVECs injury by inducing apoptosis, inflammatory response, and oxidative stress.
  • 病例报告
    Li Hui;Zhang Yongdong;Xiao Yunbing;Luo Jiming
    . 2007, 9(5): 369-370.
    A 27-year-old couple with suppurative tonsillitis received IV azithromycin 0.2 g.The next day,both of them presented with gross hematuria in the whole process of urination.Urinalysis revealed their presence of RBC(+)and(+++)respectively,and protein(+++).Their liver function,renal function,and ASO were normal. A B-ultrasonic examination found no abnormality in their urinary svstem. Azithromycin was ceased immediately.After treatment with etamsylate,vitamin C,and fluid replacement,their urine became clear gradually.During 1 month of follow-up,their urine routine maintained normalization.
  • 调查研究
    Liu Zhen;Liang Yuedong
    . 2001, 3(2): 89-92.
    Objective : To analyse ADR induced by Fufang Danshen Zhusheye. Methods: 104 ADRs due to the drug were retrieved from Chinese Pharmaceutical Abstract for statistics by sex, age of patients, the time of its occurrence, and organ - system injury. Results and Conclusion : ADR appeared mostly in groups of 31 - 60 years old and more, involving anaphylaxis and injuries of various systems and organs.
  • Adverse Drug Reactions Journal. 2020, 22(12): 719-720. https://doi.org/10.3760/cma.j.cn114015-20201217-01250
  • Ni Beibei, Qin Miao, Sun Chen, Li Jing
    Adverse Drug Reactions Journal. 2020, 22(8): 471-476. https://doi.org/10.3760/cma.j.cn114015-20190527-00449
    Parenteral nutrition-associated cholestasis (PNAC) is a common and serious complication of newborns receiving parenteral nutrition support for more than 2 weeks. The occurrence of PNAC may be the result of multiple factors. Premature birth, low birth weight, long-term parenteral nutrition, lack of enteral feeding, patent ductus arteriosus, necrotizing enterocolitis, intestinal bacterial overgrowth, bacterial translocation, and imbalance of parenteral nutrition components or containing toxic ingredients are all risk factors of neonatal PNAC. The mechanism of PNAC is not clear, which may be related to the change of bile salt enterohepatic circulation, intestinal flora translocation, improper use of fat emulsions, improper use of amino acids and carbohydrate, and excessive trace elements. The prevention measurements of PNAC mainly include early enteral feeding, optimization of parenteral nutrition components, light protection during the use of nutrient solution, and so on. The therapeutic strategies of PNAC are limited, drugs such as ursodeoxycholic acid, erythromycin, phenobarbital, and rifampicin can be considered.
  • 安全合理用药
    Yu Aihea;Zhang Xiaoshub;Deng Minga
    . 2008, 10(2): 110-6.

    The common atypical antipsychotics are aripiprazole, clozapine, olanzapine, quetiapine, risperidone, and ziprasidone. Sex differences are presented in the pharmacokinetics and adverse reactions of atypical antipsychotics. Because of the lower CYP1A2 activity in women, the plasma clozapine and olanzapine concentrations are higher in women than in men. Risperidone causes hyperprolactinaemia in women, which lead to higher incidence rates of osteoporosis and sexual dysfunction in women than in men. Studies suggest that the incidence rate of metabolic syndrome is higher in women than in men: the incidence rates of obesity, hypertension, hypertriglyceridemia and decreased HDL level in women and men are 76.3% vs 35.5%, 46.9% vs 47.2%, 42.2% vs 50.7%, 48.9% vs 63.3%, respectively; the incidence rates of hyperglycemia [≥100 mg/dl(5.55 mmol/L) and ≥110 mg/dl(6.10 mmol/L)] in women and in men are 30.0% vs 21.7% and 24.2% vs 14.1%, respectively. The incidence rates of prolonged QTc interval and extrapyramidal symptoms of atypical antipsychotics are higher in women than in men. Some atypical antipsychotics have adverse effects to the fetus.

  • 综述
    . 2005, 7(6): 401-407.
    本文根据近年国内外文献资料,对临床常用氟喹诺酮类药物的不良反应进行了分析,并概述其不良反应的机制与化学结构的关系。其中N1、C5、C7、C8取代基与不良反应的程度相关;C2的H、C6的F均不可取代,与抗菌药效关系密切,与不良反应无关;C3、C4与DNA螺旋酶结合,也与药物间相互作用有关。经验表明,临床医师在新药应用与研究开发中了解药物不良反应的监测资料是十分重要的。
  • Liu Xun, Sun Bo, Zhang Huizhi, Zhang Ying, Zhao Baohong
    Adverse Drug Reactions Journal. 2020, 22(10): 583-584. https://doi.org/10.3760/cma.j.cn114015-20191125-00947
    A 24-year-old female patient took about 150 carbamazepine tablets (15 g). About 17-hours later, she was found unconscious and frequent convulsions by her family and was immediately sent to the hospital. Laboratory tests showed that the serum concentration of carbamazepine was 58.7-mg/L, creatine kinase was 411-U/L, C-reactive protein was 23.7-mg/L, and blood oxygen saturation was 0.78. Toxic encephalopathy and status epilepticus induced by carbamazepine were diagnosed. Oxygen inhalation, ECG monitoring, intravascular fluid supplement, diuresis, bedside blood filtration, and symptomatic and suppor- tive treatments were given immediately. On the 2nd day, the number of epileptic seizures decreased and the serum concentration of carbamazepine decreased to 32.9-mg/L. On the 3rd day, the patient′s consciousness recovered and seizures occurred occasionally; on the 4th day, the serum concentration of carbamazepine decreased to 12.3-mg/L, and her convulsion disappeared. After 3 days of continued treatments, the patient recovered and discharged.
  • Chen Xiaolin, Li Haixi, Yang Jie, Yang Hai
    Adverse Drug Reactions Journal. 2022, 24(7): 371-373. https://doi.org/10.3760/cma.j.cn114015-20210909-00984
    A 64-year-old female patient with paraganglioma received intramuscular injection of metoclopramide hydrochloride injection 10-mg to prevent chemotherapy-induced vomiting. Five minutes later, he developed palpitation, sweating, headache, limb weakness, and other discomfort symptoms, and the blood pressure increased to 214/101 mmHg. Hypertensive crisis was diagnosed. Urapidil 25-mg was given intravenously, and the blood pressure in the patient was continuously monitored. About 12-hours later, the patient′s symptoms were improved and the blood pressure gradually returned to normal. It is suggested in the label that metoclopramide should not be used in patients with pheochromocytoma and paraganglioma. The patient suffered from hypertension crisis due to the use of the drug, and the hospital stay was prolonged, so it was grade F medication error.
  • 安全用药
    . 2003, 5(2): 91-94.
  • 论著
    Fang Kuaifa①;Liu wenbing①;Tan Lifu①;Zhang Yihui①;Wu Pingsheng②;Bao Taicheng①
    . 2006, 8(4): 258-261.
    Objective:To investigate the effects of metoprolol on erectile function in hypertensive young men.Methods:The erectile function of 69 hypertensive young men receiving metoprolol therapy(50~150 mg/d)was investigated.The follow-up of investigation was over 12 months,and the international index of erectile function(IIEF-5)was adopted.Results:The incidence of erectile dysfunction was 79.41% after metoprolol therapy,and 36.76% and 66.18% after 3 months and 6 months of therapy respectively(P<0.01).The severity of erectile dysfunction was in direct proportion to duration and dosage of metoprolol treatment.Conclusion:Metoprolol could cause erectile dysfunction in hypertensive young men.Therefore,it is necessary to select propriate antihypertensive drugs,and use the drugs with rationality in order to decrease or avoid the occurrence of drug-induced erectile dysfuncion.
  • ADR监测
    . 2001, 3(2): 93-99.
    我们将药物不良反应定义为“药物用于防治疾病而引起可以觉察到的有害的或不利的反应,这预示着继续给药会有危险,需要预防或特定治疗措施,或减少剂量,乃至停药”,这样一些反应现今以世界卫生组织不良反应术语(WHO-ART)进行报告,后者终将成为国际疾病分类(ICD)的一个组成部分。药物不良反应可分为6类(首字母记忆法):剂量相关型(Augmented,剂量增大),剂量无关型(Bizarre,异乎寻常),剂量相关和时间相关型(chronic,慢性),时间相关型(Delayed,迟发),停药型(End of use,终止使用),治疗失败型(Failure,失败)。时间关联,疾病类型,调查结果,再激发诸方面有助于确认可疑药物不良反应的因果关系。管理包括停药(如果可能的话),及对药物不良作用进行特殊治疗。可疑的药物不良反应应该报告,监测方法能够检出不良反应,并证实其因果关联。
  • Tong Yuanxu, Li Yan, Wei Yali, Qi Lu, Liu Chen, Li Shuang, Wang Xinghe
    Adverse Drug Reactions Journal. 2022, 24(6): 308-313. https://doi.org/10.3760/cma.j.cn114015-20220224-00149
    Objective To compare the safety of the generic and the original regorafenib tablets. Methods Two single center, randomized, open-label, 2-period self-crossover phase I clinical trials (single dose) were conducted under fasting condition and with low-fat meal respectively in healthy adult volunteers. The test preparation (T) of regorafenib was produced by Beijing Sl Pharmaceutical Co.,Ltd. and the reference preparation (R) was produced by Bayer HealthCare Pharmaceuticals Inc. In the 2 trials, male healthy subjects were randomly divided into 2 groups, respectively, and took 2 times of the preparations with different order in each group, which were R-T group (subjects took R on day 1 and then T on day 13) and T-R group (subjects took T on day 1 and then R on day 13). The subjects took drugs under fasting condition and with low-fat meal in the 2 trials respectively. After medication, vital signs detection, electrocardiogram, general physical examination, blood routine, blood biochemical, coagulation function, and other tests were performed regularly, and the occurrence of adverse events (AEs) were recorded and the severity of AEs was assessed. Results Sixty-four subjects were enrolled in the trial under fasting condition, including 32 in the T-R group and 32 in the R-T group, and the safety data was obtained from 61 and 57-subjects taking T and R, respectively. Seventy-six subjects were included in the postprandial trial, including 38 in the T-R group and 38 in the R-T group, and the safety data was obtained from 74-subjects taking T and R, respectively. In the 2 trials, there was no significant difference in the incidence of AEs between subjects taking T and those taking R [41.0% (25/61) vs. 31.6% (18/57), χ2=1.125, P=0.289; 56.8% (42/74) vs. 45.9% (34/74), χ2=0.183, P=0.188]. A total of 230 AEs occurred in the 2 trials, of which 228 cases were grade 1 (99.1%, 131 and 97 AEs occurred in subjects taking T and R, respectively), 2 cases were grade 2 (0.9%, 1 AE occurred in subjects taking T and R, respectively), and no grade ≥ 3 AEs occurred. The types of AEs occurred in the 2 trials were the same, of which bradycardia was the most common, followed by prolonged QT interval of ECG. All ECG abnormalities were found during routine examinations, and no subjects had obvious clinical symptoms. Conclusion The safety of the generic and the original regorafenib tablets was consistent after a single dose administration under fasting condition and with low-fat meal.
  • 安全合理用药
    Fang Jianguo;Liu Dan
    . 2008, 10(6): 0-0.
    Fluoxetine is one of the selective serotonin reuptake inhibitors, which is often used for treating depression and obsessivecompulsive disorder. Fluoxetine cardiotoxicity includes arrhythmia, torsades de pointes ventricular tachycardia, QT internal prolongation syndrome, serious cardiac damage, and death. The mechanism of cardiac adverse reactions caused by fluoxetine remains uncertain presently. Fluoxetine can cause interactions with some drugs that are metabolized by CYP2D6 leading to cardiac adverse reactions. Clinicians should exercise caution when prescribing fluoxetine to patient with cardiovascular disease, female patients, and elderly patients. ECG monitoring might be performed, if necessary.
  • 安全用药
    Du Liping;Mei Dan
    . 2010, 12(4): 255-7.

    Immunization is one of the most important ways to prevent and control infectious diseases. An increase in vaccine use would lead to more adverse events following immunization (AEFI). The Chinese Center for Disease Control and Prevention classified AEFI into 7 categories: general reaction, unusual reaction, vaccine quality event, program error event, coincidental event, psychogenic reaction, and reaction of unknown cause. The adverse reactions after vaccination of Hepatitis B vaccine, bacille CalmetteGuerin vaccine, oral polio vaccine, measlesmumpsrubella vaccine, pertussisdiphtheriatetanus triple vaccine, Japanese encephalitis vaccine, haemophilus B conjugate vaccine, rabies vaccine, and influenza A (H1N1) vaccine and monitoring and management of AEFI were discussed, so as to provide reference for enhancement of the safety of immunization

  • 论著
    Su Henghai;Mu Guangyan;Xiang Qian;Zhou Ying;Cui Yimin
    . 2014, 16(1): 15-7.

    ObjectiveTo understand occurrence of bleeding related to drug interactions in patients who received combined treatment with warfarin and other drugs in Department of Cardiovascular Medicine and investigate control measures.MethodsThe data of inpatients using warfarin in the Department of Cardiovascular Medicine, Peking University First Hospital from January 2012 to June 2013 were collected and analyzed retrospectively. The conditions of concomitant drugs and occurrence of bleeding possibly caused by drug interactions were recorded and the drugs which were commonly used in the Department were screened.ResultsA total of 141 patients were enrolled including 90 men aged from 21 to 83 years with an average age of (63±13) years and 51 women aged from 43 to 85 years with an average age of (65±11) years. Most protopathy was atrial fibrillation which accounted for 79.4% (112 cases). Of the 141 patients, there were 14 cases (9.9%) of slight bleeding possibly because of drug interactions including 5 cases of stool occult blood, 3 cases of dermal ecchymosis and 1 case had each of the following: operative wound bleeding, oral mucosal bleeding and blood in phlegm, colporrhagia, epistaxis, hematuresis, and gum bleeding. The occurrence of bleeding in the 14patients involved totally 9 kinds of drugs containing low molecular weight heparin (related to 9 cases), atorvastatin (related to 6 cases), amiodarone (related to 4 cases), acarbose (related to 3 cases), aspirin (related to 4 cases), propafenone (related to 3 cases), omeprazole (related to 2 cases), clopidogrel (related to 2 cases), and moxifloxacin (related to 1 case) and, of them, the highest occurrence was due to low molecular weight heparin, which accounted for 64.2%. In the 9 kinds of drugs in the 141 patients, low molecular weight heparin had the highest concomitant frequency combined with warfarin accounted for 731%(103/141) and moxifloxacin had the highest bleeding incidence accounted of 1/5.ConclusionsBleeding may be caused by drug reactions due to combination therapy with warfarin and parts of clinical common cardiovascular drugs. Positive clinical pharmaceutical care of warfarin will be of great importance in prevention of bleeding.

  • Zhang Meijuan, Yin Hang, Li Jiangshuo, Hou Mengyu, Wu Jingxuan, Dong Ruihua
    Adverse Drug Reactions Journal. 2023, 25(8): 460-468. https://doi.org/10.3760/cma.j.cn114015-20221230-01194
    Objective To mine and compare the adverse event (AE) signals of allopurinol and febuxostat and provide reference for the rational and safe use of the 2 drugs in clinic. Methods The AE reports on allopurinol and febuxostat from January 1, 2009 to December 31, 2021 were collected by searching the US Food and Drug Administration Public Data Open Project (openFDA) database. AEs were classified using preferred term (PT) and systemic organ class (SOC) of the International Medical Terminology Dictionary 25.0. The AE risk signals of allopurinol and febuxostat were mined using the reporting odds ratio (ROR) method. The number of AE reports ≥3 and the lower limit of the 95% confidence interval (CI) of the ROR>1 was defined as a positive signal. The new AE risk signals of allopurinol and febuxostat were screened according to the drug labels. The radar chart was drawn according to the number of allopurinol and febuxostat risk signals. The positive PT signals were descriptively and statistically analyzed. Results The number of AE reports of allopurinol and febuxostat were 105-532 and 9-949, respectively. The analysis of the top 100 AE reports were as follows. There were 82 positive PT signals of allopurinol, involving 14 SOCs, and 61 AEs were not recorded in the drug labels; there were 86 positive PT signals of febuxostat, involving 18 SOCs, and 25 AEs were not recorded in the drug labels. The top 5 PTs in the signal strength of allopurinol were drug reaction with eosinophilia and systemic symptoms, end-stage renal disease, hypercalcemia, acute kidney injury, and chronic kidney disease; the top 5 PTs in the signal strength of febuxostat were enthesopathy, granu- loma skin, blood parathyroid hormone decreased, tenosynovitis and alanine aminotransferase abnormal. The 2 drugs had a total of 49 overlapping signals. More AE signals of allopurinol were detected in SOCs of meta- bolic and nutritional diseases, blood and lymphatic system diseases etc.; more AE signals of febuxostat were detected in SOCs of skin and subcutaneous tissue diseases, various musculoskeletal, and connective tissue diseases, etc. Conclusions Allopurinol has a higher risk of causing AEs related to kidney and urinary system, blood and lymphatic system, and metabolic system, while febuxostat has a higher risk of causing AEs related to skin and subcutaneous tissue, musculoskeletal and connective tissue, and hepatobiliary system. It is suggested that patients with gout accompanied by renal insufficiency, urinary system diseases or blood disea- ses should be careful with allopurinol, and the patients with gout accompanied by liver dysfunction should be careful with febuxostat.
  • 调查研究
    Lin Yang;Chen Yan
    . 2006, 8(3): 181-184.
    Objective: To investigate and analyse the rationality of use and cost of antimicrobials for prophylaxis during surgical procedures. Methods: The medical records of 83 surgical patients in a hospital were collected from the 1st to the 31st of October,2005,and the rationality of use and cost of antimicrobials was analysed. Results: The irrational use of antimicrobials during surgical procedures was as follows: The duration of antimicrobials use was more than 2 days(80/83,96.4%). The timing of the first dose was not within 2 hours before incision. The selection of antimicrobials was incorrect(54/83,65.1%). Secondly,the antimicrobials effect was influenced by inappropriate combination,dosage and dilution. In addition,the susceptibility testing was ignored. The investigation showed that the application of antimicrobials was higher(100%),while the cost of antimicrobials was reasonable,it accounted for 21.9% in total. Conclusion: It is necessary to carry out "Guidelines on Clinical Use of Antimicrobials"for some inappropriate uses of antimicrobials for prophylaxis during surgical procedures in order to improve the rational use of antimicrobials.
  • 学术研讨
    . 2004, 6(5): 297-299.
    本文介绍了静脉药物配置中心(PIVA)药学服务工作的实践与体会,为静脉药物集中配制工作的开展提供借鉴与参考。在PIVA里,药师将充分发挥药学专业知识专长,通过审核处方,可有效地提高合理用药水平,减少用药失误;PIVA高洁净度的配置环境及规范化的配制操作过程,保证了药液的无菌性、稳定性、相容性和输液质量;药品实行集中管理,有利于减少药品流失、降低分剂量成本。PIVA的启用拓展了药学服务内涵,使其职能由传统调配型向″以病人为中心″的药学服务模式转变。
  • Wu Shiqi, Zhu Xuelu, Su Su, Ma Wenyao, Wang Chunguang, Yan Suying, Yue Xiaolin
    Adverse Drug Reactions Journal. 2023, 25(10): 584-591. https://doi.org/10.3760/cma.j.cn114015-20221230-01197
    Objective To investigate the current status of polypharmacy among elderly outpatients with 4 types of chronic diseases such as hypertension, diabetes mellitus, coronary atherosclerotic heart disease, and cerebrovascular disease. Methods A retrospective study was conducted on the drug use of elderly (≥65 years old) outpatients with hypertension, diabetes mellitus, coronary atherosclerotic heart disease, and cerebrovascular disease with data of Beijing Municipal Health Insurance Centre database from July 2017 to September 2017. The included patients had at least 1 of 4 types of chronic diseases. Polypharmacy was defined as ≥5 different types of medication at the first visit, and non-polypharmacy was defined as <5 types of medication. The number and severity of comorbidity were quantified using the Charlson Comorbidity Index (CCI), and the prognosis of patient was evaluated at 4 levels of 0, 1, 2, and ≥3 scores. The larger the value, the more severe the disease. Based on the Beers Criteria 2015, the potential inappropriate medication (PIM) was identified using the prescription review system of Puhua Health. Results A total of 405-608 patients were included in this study, with a median age of 74 (65-107) years , and 204-219 patients (50.35%) were female. According to the type of medication used by patients, they were divided into polypharmacy group (113-594 cases, 28.01%) and non-polypharmacy group (292-014 cases, 71.99%). The CCI of the polypharmacy group was significantly higher than that of the non-polypharmacy group (P<0.001). The proportion of patients with 0, 1, 2, and ≥3 scores in the polypharmacy group was significantly higher than that of the non-polypharmacy group, and the differences were statistically significant (all P<0.001). In terms of comorbidity, the proportions of patients among the 4 types of chronic diseases were higher in the polypharmacy group than in the non-polypharmacy group (P<0.001). In terms of concomitant diseases, the proportion of patients with hyperlipidemia, cognitive impairment, heart failure, and osteoporosis in the polypharmacy group was higher than that in the non-polypharmacy group (all P<0.001). In terms of medical treatment behaviour, the median number of medical visits was higher in the polypharmacy group than in the non-polypharmacy group [2(1,3) vs. 1(1,2), P<0.001]. In terms of evaluating the unsuitability of medication, the proportion of patients with PIM in the polypharmacy group was higher than that in the non-polypharmacy group, including repeated medication [4.60% (5-227/113 594) vs. 1.64% (4-486/292 014)], contraindications [2.97% (3-376/113 594) vs. 1.13% (3-294/292 014)], interactions [6.51% (7-399/113 594) vs. 1.94% (5-658/292 014)], and lack of indications [22.39% (25-432/113 594) vs. 13.54% (39-543/292 014)], and the differences were all significant (all P<0.001). In terms of drug use categories, the top 5 most commonly prescribed drugs in the polypharmacy group were HMG-CoA reductase inhibitors (68-318 cases, 60.14%), dihydropyridines (60-951 cases, 53.66%), angiotensin receptor antagonists(45-050 cases, 39.66%), β-receptor blockers (25-675 cases, 22.60%) and sulfonylureas (16-023 cases, 14.11%). Conclusions Polypharmacy is common in elderly patients with hypertension, diabetes mellitus, coronary artery disease, and cerebrovascular disease. The elderly patients with polypharmacy have a worse baseline status and more problems with PIM.
  • 调查研究
    Ding Xiaoli;Lei Zhaobao
    . 2005, 7(5): 336-339.
    Objective: To investigate the characteristics and causative factors of tiopronin-induced anaphylatic shock for its rational use in clinic. Methods: Domestic medicine periodicals were searched between January 2000 and June 2005, and 38 cases with tiopronin-induced anaphylatic shock were analysed. Results: Routine dosages of tiopronin were administered by intravenous infusion in all cases. 86.84% of the cases developed anaphylactic shock within 30 minutes after administration, more male than female(P<0.01). Clinical symptoms of anaphylactic shock were mainly repid decrease in blood pressure, chest distress, dyspnea and chill. Allergic reactions of skin were uncommon. 97.37% of the cases(37/38) were recovered after treatment, and most cases(81.85%, 31/38)improved within one hour. Conclusion: Physicians should attach importantce to the rational use of tiopronin in clinical practice.
  • 论著
    Cai Haodong;Ma Xiuyun;Cao Chuanmei;Xu Yanli;Bu Zhijun
    . 2007, 9(1): 7-10.
    Objective: To compared the antiviral effects and safety of entecavir with those of lamivudine. Methods: Thirty-three patients with no prior history of antiviral therapy were divided randomizely into two groups: entecavir group (16 cases), and lamivu- dine group (17 cases). The dosage in the entecavir group and lamivudine group was 0.5 mg/d and 100 mg/d, respectively, and the duration of therapy was 48~96 weeks. The effects of entecavir and lamivudin on HBV DNA, ALT, HBeAg/HBeAb seroconversion, and their adverse reactions were observed during the treatment. Results: The patients with undetectable serum levels of HBV DNA in the entecavir group were more than those in the lamivudine group, that is, 56.25% versus 29.41% on week 24, and 87.50% versus 29.41% on week 48 after treatment. There were no marked differences in the HBeAg negative conversion rate, HBeAg/HBeAb seroconverse rate, and the incidence of adverse reactions between the two groups. Conclusion: Entecavir is more effective in …更多inhibiting reproduction of HBV than that of lamivudine, and entecavir is similar to lamivudine in the incidence of adverse reactions;therefore, entecavir could be used for long-term treatment of the patients with chronic hepatitis B.
  • 学术研讨
    . 2004, 6(5): 294-297.
    治疗药物监测(TDM)的目的是促进药物个体化治疗。本文通过多年的TDM实践,总结了药物剂量-血药浓度-疗效和不良反应之间的相关性,并重点举例说明TDM对各种常用药物安全应用的重要性,呼吁临床检验师、药师和医师的密切合作,运用多学科知识将TDM推向更高水平,使药物不良反应得到早期警示,以提高药物治疗的有效性和安全性。
  • Ma Jianping, Gu Lili
    Adverse Drug Reactions Journal. 2022, 24(10): 557-558. https://doi.org/10.3760/cma.j.cn114015-20220119-00056
    A 31-year-old female patient took ibuprofen sustained-release capsules (ibuprofen) 0.3 g by herself due to persistent dull pain in both sides of the waist during menstruation. Three hours later, she developed nausea and vomiting, weakness, and poor appetite. Laboratory tests showed serum creatinine 173-μmol/L, glomerular filtration rate 33-ml/(min·1.73 m2), urea 10.7-mmol/L, and uric acid 428-μmol/L. Ibuprofen-related acute kidney injury was considered. Then she received intravenous injection of methylprednisolone sodium succinate 20-mg once daily by micro injection pump and symptomatic treatments. After 14 days of treatments, her serum creatinine was 89-μmol/L, glomerular filtration rate 84.1-ml/(min·1.73 m2), and urea 8.0-mmol/L; after 21 days, her serum creatinine was 78-μmol/L, urea 3.9-mmol/L, and uric acid 313-μmol/L.
  • Zhang Wen, Wang Xusheng, Liu Yunxia, Lu Cuicui
    Adverse Drug Reactions Journal. 2021, 23(1): 30-34. https://doi.org/10.3760/cma.j.cn114015-20200331-00304
    Immune checkpoint inhibitors (ICIs)-associated immune-mediated hepatitis (IMH) is a special type of drug-induced liver injury. The risk factors of IMH include combination of different types of ICIs, comorbidities, fever, etc. Most patients with IMH are asymptomatic, but laboratory tests show mainly abnormal levels of serum transaminase. It is crucial for patients with IMH to stop or delay the use of ICIs and receive immunosuppressive therapy. The immunosuppressive therapy for IMH usually includes glucocorticoids, and the immunosuppressive agents such as tacrolimus, mycophenolate mofetil, etc. can also be added.
  • 滥用误用
    . 2007, 9(2): 117-120.
    曲马多是一个应用比较广泛的中枢作用镇痛药,临床应用已近30年。它具有镇痛作用较强、依赖性相对较弱的特点。国际上对曲马多滥用及其不良反应的监测表明,曲马多滥用的发生率为2~3/10万。近年来,在我国部分地区发生曲马多流行性滥用。本文就曲马多的药理学特点,结合国际上对曲马多依赖性的评议以及我们此前的流行病学调查结果,对曲马多依赖性进行综述和分析。
  • Yang Lu, Lin Huanyu, Xie Shanshan, Wan Jinjin, Ao Jian'gen, Zhang Weifang
    Adverse Drug Reactions Journal. 2022, 24(5): 278-280. https://doi.org/10.3760/cma.j.cn114015-20211025-01093
    A 63-year-old male patient with prostate cancer was treated with bicalutamide (50-mg orally, once daily) combined with goserelin sustained-release implant (10.8-mg subcutaneously once every 3 months), and 27 months later, goserelin was replaced by leuprorelin sustained-release microspheres (3.75-mg subcutaneously once a month). At the 32nd month after bicalutamide treatment, the patient developed progressive dyspnea and decreased physical activity without obvious inducement. At the 36th month after administration of bicalutamide, the patient developed mild edema of both lower limbs. Cardiac color Doppler ultrasound showed that the diameters of left and right atrium were 48 and 45-mm respectively, the left ventricular diameters at end systole and end diastole and the right ventricle diameter were 49, 57, and 28-mm respectively, and the left ventricular ejection fraction was 28%. Laboratory test showed that the precursor of B-type brain natriuretic peptide was 4-533-ng/L. Dilated cardiomyopathy caused by bicalutamide was considered. Bicalutamide was discontinued, leuprorelin was injected subcutaneously at a dose as before, and metoprolol, sacubitril and valsartan, and spironolactone were given. After one month of treatment, the patient′s above symptoms disappeared. Cardiac color Doppler ultrasound showed that the diameters of left and right atrium were 40 and 44-mm, respectively, the left ventricular diameters at end systole and end diastole and the right ventricle diameter were 44, 53, and 29-mm, respectively, and the left ventricular ejection fraction was 36%. The precursor of type B brain natriuretic peptide was 1-539-ng/L
  • 安全用药
    Chen Jing;Li Jian
    . 2010, 12(5): 321-4.
    Rituximab is a human/mouse chimeric anti-CD20 monoclonal antibody mainly used in the treatment of non-Hodgkin’s lymphomas. The most common rituximab-caused adverse reaction is acute infusion-related reactions and serious adverse reactions are rare. This article reviews the rituximabinduced rare adverse reactions,such as acute respiratory distress syndrome, diffuse alveolar hemorrhage, cardiac arrhythmia, sudden cardiac death, chronic heart failure, progressive multifocal leukoencephalopathy, tumor lysis syndrome, and cytokine release syndrome, as well as the possible pathogenesis,clinical features, and the management in order to provide references for safe rituximab use in clinical practice.
  • 药源性疾病
    Geng Fengying;Yang Yue;Jin Dan;Yang Hua;Ma Hui;Yang Yueming;Wang Yuxin
    . 2008, 10(6): 0-0.
    Druginduced headaches refer to a headache caused either directly or indirectly by medications, which account for 5%~10% of the headaches. Mechanism of druginduced headaches is unclear. The comnon causes of drug-induced headaches are as follows: vasodilation, benign intracranial hypertension, aseptic meningitis, disulfiram-like reactions, and analgesic overuse. Clinical presentation of druginduced headaches may be accompanied by dizziness, nausea, vomiting, facial flushing, and decreased blood pressure, besides headache symptoms. The most common causative agents include NSAIDs, histamine H2 receptor antagonists, calcium antagonists, and vasodilators. Care must be taken to distinguish a headache during drug therapy from a headache secondary to the primary disease. The symptoms of druginduced headaches may relieve after stopping the offending agents and receiving symptomatic therapy.
  • Wang Rongrong, Liu Jiao, Leng Ping
    Adverse Drug Reactions Journal. 2023, 25(12): 766-768. https://doi.org/10.3760/cma.j.cn114015-20221121-01075
    A 61-year-old male patient with diffuse large B-cell lymphoma received BeEAM pre-treatment measures such as bendamustine, cytarabine, etoposide, and melphalan for autologous hematopoietic stem cell transplantation. Anti-infective treatments such as aciclovir, posaconazole, levofloxacin, biapenem, and vancomycin were administered successively.Before the pre-treatment of transplantation, the patient′s blood potassium was 4.1-mmol/L, and after 7 days of treatment with posa- conazole and levofloxacin, the blood potassium was 3.4-mmol/L. Intravenous and oral potassium supple- mentation was administered. After 5 days of potassium supplement, the patient developed atrial fibrillation, with blood potassium level of 3.3-mmol/L. After continuing potassium  supplement for 7 days, his blood potassium level remained 3.0-mmol/L. After excluding causes of other drugs, it was considered that hypokalemia might be related to posaconazole. The posaconazole was discontinued and switched to voriconazole; 3 days later, his blood potassium returned to 4.2-mmol/L. During a 3-month of follow-up, multiple examinations showed that the blood potassium levels were within the reference range.
  • 安全用药
    Lü Qiujun;Cao Ping
    . 2010, 12(6): 410-5.
    Pharmaceutical excipients refer to any substances other than the active principal in the pharmaceutical preparation. Their functions are to protect, support or enhance the stability and bioavailability of the active ingredient besides formulating a dosage form. It is reckoned that 40 kinds and more of pharmaceutical excipients including over one thousand different materials are now used in the manufacturing of pharmaceutical products, such as solvents, absorbents, preservations,colouring agents, flavouring agents, thickening agents, antioxidants, and so on. In addition,new classes of excipients have been available in recent years. Pharmaceutical excipients are considered to be inert in contrast to active drug. However, adverse reactions to a wide range of excipients are now documented, such as hemolysis to propylene glycol, gasping syndrome to benzyl alcohol, etc. The safety of pharmaceutical excipients involves their toxicity, quality, and improper use. The clinicians should be aware of the adverse reactions associated with pharmaceutical excipients, and drug regulatory authority should strengthen the management of the safety of pharmaceutical excipients in order to safeguard the patient safety.
  • Jin Sisi, Jia Jinsheng
    Adverse Drug Reactions Journal. 2020, 22(9): 541-542. https://doi.org/10.3760/cma.j.cn114015-20191111-00901
    A 73-year-old male patient with myelodysplastic syndrome received deferasirox dispersible tablets (deferasirox) 500-mg once daily for post-transfusion iron overload. Renal function examination showed no obvious abnormality. Ten months later, the dose of deferasirox was increased to 1-000-mg once daily due to ineffective iron overload treatment. About 1 month after the dose adjustment, the patient′s fatigue was aggravated. Laboratory tests showed blood urea (BUN) 11.5-mmol/L, serum creatinine (Scr) 143-μmol/L, and estimated glomerular filtration rate (eGFR) 45-ml/(min·1.73 m2). Kidney injury was diagnosed, which was considered to be induced by deferasirox. Then deferasirox was stopped and Corbrin capsule (百令胶囊) was given. About 1 month after drug withdrawal, renal function of the patient was improved [BUN 9.1-mmol/L, Scr 111-μmol/L, and eGFR 60-ml/(min·1.73 m2)]. Due to the iron overload, deferasirox was re-given at dose of 1-000-mg once daily. About 1 month after medication, the kidney injury recurred [BUN 9.7-mmol/L, Scr 131-μmol/L, and eGFR 49-ml/(min·1.73 m2)]. The dose of deferasirox was reduced to 500-mg once daily immediately and 3 month later, renal function of the patient was improved [BUN 8.8-mmol/L, Scr 104-μmol/L, and eGFR 65-ml/(min·1.73 m2)].
  • Li Qiuyue, Sun Wenjuan, Zou Yuzhen, Jiao Lei, Hu Yang
    Adverse Drug Reactions Journal. 2020, 22(5): 306-310. https://doi.org/10.3760/cma.j.cn114015-20181030-01068
    Medication Safety Officer Society was established in America in 2013 to emphasize that the Medication Safety Officer (MSO) was an integral part of the healthcare team. After that, some countries in North America and European promulgated a series of drug safety guidelines and protocols through the relevant organizations or agencies, thus to establish the normative work pattern, content, and process of MSO. The MSO plays the role of medication safety leaders, medication safety experts, medication safety program practitioners, medication safety researchers, and medication safety educators. Based on the international MSO mode, our hospital has built up a team consisted of the pharmacy department′s director and clinical pharmacists, which has similar functions in MSO, to be responsible for medication safety of the whole hospital. The team has become the member of Drug Alert Workstation of Beijing Drug Administration. They participate in multidisciplinary drug safety research, analyze the data of Beijing ADR Monitoring Centre, and have improved the drug emergency plan in our hospital. The work mode for drug safety in our hospital include pre-warning, real-time tracking, and post-feedback.
  • Ma Jie, Wang Nan, Song Yanqing, Li Yueyang
    Adverse Drug Reactions Journal. 2020, 22(5): 321-323. https://doi.org/10.3760/cma.j.cn114015-20181214-01242
    An 8-year-old female patient received meropenem for intracranial infection after brainstem tumor resection for 13 days, but the infection was poorly controlled. Teicolanine was added and the fever was relieved 5 days later. After 2 days of the relief, the patient regained fever (body temperature was up to 39.3-℃), her upper body skin was red with itching, and the skin on the trunk and limbs was scattered with flaky red maculopapular rashes. Routine blood examination showed white blood cell count 1.07×109/L, neutrophils 0.03, and neutrophils count 0.03×109/L. Red man syndrome and neutropenia in the patient was considered. Teicolanine was discontinued and symptomatic treatments were given for 5 days. Her symptoms were not improved. Then meropenem was discontinued for 2 days but her symptoms were also not improved. Due to the infection, meropenem was re-given and methylprednisolone was added. The symptoms of adverse reactions were gradually improved and finally subsided completely and neutropils returned to normal. Then methylprednisolone was stopped. Meropenem was continued for 7 days and the symptoms above did not recur.
  • 安全合理用药
    Zi Mei①;Li Xiangxia②
    . 2007, 9(3): 182-185.
    Orlistat, a novel non-systemic treatment for obesity, is a gastrointestinal lipase inhibitor which decreases intestinal fat absorption and promotes loss of weight. The common adverse reactions of orlistat are gastrointestinal disturbances, uncommon adverse reactions are liver damage, anaphylactic reaction, etc. The purpose of this paper is to provide basis for rational application of orlistat in clinical practice
  • Sun Lu, Zhao Huanyu
    . 2017, 19(2): 84-88.
  • Wang Yu, Xie Yifan, Zhang Zhuoli
    Adverse Drug Reactions Journal. 2020, 22(8): 445-449. https://doi.org/10.3760/cma.j.cn114015-20190830-00716
    Febuxostat, a new selective xanthine oxidase inhibitor, is approved by the U.S. Food and Drug Administration in 2009 for the treatment of gout and hyperuricemia. The study on the "cardiovascular safety of febuxostat and allopurinol in patients with gout and cardiovascular comorbidities (CARES)", which was published in 2018, showed that febuxostat could increase the risk of all-cause mortality and cardiovascular related death in gout patients with cardiovascular disease. However, the subsequent clinical studies have not confirmed that febuxostat could increase the risk of cardiovascular events-related death. The inconsistent results of the studies on cardiovascular safety of febuxostat suggest that the gout patients with cardiovascular disease may benefit from continuous uric acid lowering therapy. However, during the process of using febuxostat, the risk of cardiovascular events and cardiovascular events-related death should be alerted, the combination medication and renal function of patients should be paid attention to, and the xanthine oxidase inhibitor withdrawal syndrome should be prevented.
  • Jiang Yongxian, Chen Wenwen, Yang Jia, Tao Wanjun, Li Gen
    Adverse Drug Reactions Journal. 2021, 23(2): 91-94. https://doi.org/10.3760/cma.j.cn114015-20200605-00635
    Chengdu Women and Children′s Central Hospital started the construction of a pharmacovigilance system in 2017. In August of that year, 3 venous thrombosis events related to off-label use of heamocogulase agents occurred consecutively within 1 month, which aroused the vigilance of the hospital pharmacovigilance department. And these events were designated as the risk signals of pharmacovigilance. Then the application of heamocogulase agents in the whole hospital was investigated. Intervention measures including formulation of clinical application standard of heamocogulase agents, strengthening of the prescription and medical order management, and strengthening the training of medical staff on the rational use of heamocogulase agents were formulated in connection with the medication risk links, and the pharmacovigilance system of heamocogulase agents was established. From December 2017 to February 2018 after the implementation of the intervention, the consumption of heamocogulase agents decreased by 90.8% (from 6-767 to 624) and the incidences of unreasonable medication indication, irrational course of treatment, and unjustified daily dose decreased significantly, compared with those from June to August 2017 before the intervention. As of the end of 2019, no more heamocogulase agents-related venous thrombotic events have occurred.
  • 论著
    Zhan Hanqiu;Liu Hui;Sun Na
    . 2014, 16(2): 100-7.

    ObjectiveTo evaluate the efficacy and safety of human serum albumin in treatment of patients with ascites due to cirrhosis.MethodsCochrane Library, PubMed, EMBase, Web of Science, CBM, CNKI, VIP, Wanfang Database were searched by using keywords “ascites”, “albumin”, “cirrhosis” and “randomized controlled trials”. The full text papers of randomized controlled trials (RCT) about human albumin treatment in patients with ascites due to cirrhosis were collected. The articles were selected and evaluated according to the inclusion criteria. The related information was statistically analyzed with RevMan 5.2 software, the relative risk (RR) and 95% confidence intervals (CI) were calculated. The patients in experimental group received IV infusion of human serum albumin. The patients in control group received isotonic 0.9% sodium chloride injection or artificial colloid (such as hetastarch, dextran, polygeline etc.) or no drugs. The efficacy and safety were compared between the 2 groups.ResultsA total of 688 related articles were searched and 13 RCT were enrolled into the study finally. There were 11 articles in English and 2 in Chinese. A total of 1 152 patients were entered in the study. The results of Meta-analysis showed that the incidence of hyponatremia in the experimental group (7.67%) was lower than that in the control group (14.66%), the difference was statistically significant(RR=0.60,95%CI:0.41~0.88, P=0.008). The differences of the ascites regression rates (91.67% vs. 88.44%), the incidences of renal injury (5.12% vs. 6.93%), the incidences of infection (5.04% vs. 4.93%), the incidences of hepatic encephalopathy (5.90% vs. 5.00%), the incidences of hemorrhage of digestive tract (2.57% vs. 2.73%), the incidences of hyperpotassemia (1.09% vs. 6.45%), the rehospitalization rates (52.15% vs.61.82%), the rehospitalization rates due to ascites (38.68% vs. 41.85%), the hospital mortality (3.80% vs. 4.54%), and the total mortality rates (21.40% vs. 24.83%) between the experimental group and the control group were not statistically significant ( all P >0.05). The difference of incidence of adverse reactions between the experimental group and the control group (3.13% vs. 3.05%) was not statistically significant (P=097).ConclusionThe present study can not demonstrate the obvious differences in curative effect and safety between the therapies of IV infusion of human serum albumin and artifical colloid or chloride in treatment of patients with ascites due to cirrhosis.

  • 安全用药
    . 2005, 7(2): 108-111.
    本文简述抗精神失常药物所致撤药综合征的基本特征,并对抗精神病药、抗抑郁药所致撤药综合征的临床表现、发生机制与防治以及抗焦虑药引起戒断反应的高危因素、临床表现与防治作一概述。
  • Adverse Drug Reactions Journal. 2022, 24(6): 335-336. https://doi.org/10.3760/cma.j.cn114015-20220613-00522
  • 安全用药
    YAN Xu-lin;OUYANG Ying
    . 2012, 14(2): 93-5.
    Selective cyclooxygenase-2 (COX-2) inhibitors are a new type of non-steroidal anti-inflammatory drugs (NSAIDs), which are used in treatment of rheumatoid arthritis and osteoarthritis. Selective COX-2 inhibitors are divided into relatively selective COX-2 inhibitors ( meloxicam, nimesulide and diclofenac acid, and others) and highly selective COX-2 inhibitors( celecoxib, rofecoxib, valdecoxib, etoricoxib,and other). The inhibitory effect of the former against COX-2 is significantly stronger than that against COX-1, but also partially inhibits COX-1 at the same time, while the latter only has strong inhibitory effect on COX-2 inhibitor. The main adverse reactions of selective COX-2 inhibitors are gastrointestinal ulcers, perforation or bleeding, damage to renal function, coagulation disorders and thrombosis. The factors associated with the mechanisms are as follows: the COX-2 inhibitors inhibit both COX-1 and COX-2 at the same time and weaken the protective effects on the gastrointestinal mucosa; the COX-2 inhibitors decrease glomerular filtration rate and increase retention of sodium and potassium; the COX-2 inhibitors inhibit CYP2C9’s activity and decrease warfarin’s metabolic rate; the COX-2 inhibitors affect the balance between thromboxane A2 (TxA2) and prostaglandin I2 (PGI2). Proton pump inhibitors should be taken with the selective COX-2 inhibitors in order to decrease the incidence of gastrointestinal adverse reactions. For the patients with hypertension or sodium retention tendencies, plasma concentration and renal function should be monitored regularly, dose of antihypertensive drugs should be adjusted and coadministration of multiple NSAIDs at the same time should be avoided. Selective COX-2 inhibitors in combination with low-dose aspirin may prevent and cure cardiovascular adverse reactions. If adverse reactions induced by selective COX-2 inhibitors are confirmed, the drug should be discontinued and the symptomatic treatment should be given.
  • Li Zuojun, Yang Xinliang, Chen Yejun, Wang Li, Zuo Wenjian, Liu Xiaohong, Wang Chunjiang
    Adverse Drug Reactions Journal. 2021, 23(8): 440-442. https://doi.org/10.3760/cma.j.cn114015-20201209-0122
     A 42-year-old female patient who had a fever for 10 days and was suspected of cytomegalovirus infection received IV infusions of ganciclovir 150-mg dissolved in 0.9% sodium chloride injection 100-ml and cefoperazone sodium and tazobactam sodium 2.25 g dissolved in 0.9% sodium chloride injection 100-ml twice daily. Before medication, the patient′s white blood cell count (WBC) was 12.71×109/L, platelet count (PLT) was 262×109/L, ren blood cell count (RBC) was 2.99×1012/L, and hemoglobin (Hb) was 84-g/L. Because the patient developed edema 2 days later, the drugs were adjusted to IV infusions of ganciclovir 150-mg dissolved in 0.9% sodium chloride injection 50-ml once daily and piperacillin sodium tazobactam sodium 2.25 g dissolved in 0.9% sodium chloride injection 50-ml twice daily. On day 11 of medication, laboratory tests showed WBC 3.01×109/L, 2.32×109/L, PLT 92×109/L, RBC 2.39×1012/L and Hb 68-g/L; on day 13 of medication, her WBC was 1.98×109/L, PLT was 86×109/L, RBC was 2.44×1012/L,and Hb was 69-g/L. After tracing the patient′s previous medical records, it was learned that the patient had previously experienced mild myelosuppression due to ganciclovir treatment. Then ganciclovir-induced pancytopenia was considered. Ganciclovir was stopped and subcutaneous injections of recombinant human granulocyte stimulating factor injection 200-μg once daily and recombinant human erythropoietin injection 10-000 U once a week were given. Five days later, laboratory tests showed WBC 3.82×109/L, PLT 197×109/L, RBC 3.12×1012/L, and Hb 92-g/L. The patient had renal transplantion 3 years ago. According to the level of creatinine clearance rate, overdose of ganciclovir was used in the patient.
  • An Jing, Zhou Xiaona
    Adverse Drug Reactions Journal. 2023, 25(10): 633. https://doi.org/10.3760/cma.j.cn114015-20220819-00763
    A 5-year-old and 4-month-old boy took duloxetine about 1-000-mg mistakenly. After 30-minutes, symptoms such as listlessness, vomiting, muscle tremor, disturbance of consciousness, agitation delirium, high fever, tachycardia, convulsions etc. occurred successively. Severe serotonin syndrome caused by duloxetine poisoning was diagnosed and treatments such as gastric lavage, catharsis, hemoperfusion, cyproheptadine, midazolam, and physical cooling were given. Twelve hours later, laboratory tests showed creatine kinase 674-U/L, myoglobin 247-mg/L, blood urea nitrogen 9.5-mmol/L, uric acid 452-μmol/L, serum creatinine 55-μmol/L; 36-hours later, the results were creatine kinase 674-U/L, blood urea nitrogen 10.3-mmol/L, uric acid 350-μmol/L, and serum creatinine 70-μmol/L. Coenzyme Q10 and vitamin C were given to protect organ function. Eight days later, the boy′s symptoms disappeared. Laboratory tests showed creatine kinase 149-U/L, myoglobin 66-mg/L, urea nitrogen 4.3-mmol/l, uric acid 75-μmol/L, and serum creatinine 34-μmol/L.
  • 论著
    Wang Ruiqi①;Zhang Hongyu①;Wang Zhongyan②;Xue Weiguo③;Yang Xueyuan④;Liu Quanzhong⑤;Li Ming⑥; Zheng Qingshan⑦
    . 2007, 9(2): 85-90.
    Objective: To observe the efficacy and safety of fexofenadine in treating seasonal allergic rhinitis (SAR) and chronic idiopathic urticaria (CIU). Methods: In a double-blind, double-dummy, randomized, controlled, multicenter phase Ⅱ clinical trial, the efficacy and safety of fexofenadine (60 mg twice daily) were compared with cetirizine (10 mg/d) in the treatment of SAR and CIU. The duration of treatment was 14 d for patients with SAR and 28 d for patients with CIU. Results: One hundred and forty-four patients with SAR entered the trial. Of the 144 patients, 64 receiving fexofenadine and 68 receiving cetirizine were included in PPS. The symptom score reducing index and overall effective rate in fexofenadine group were 0.719±0.182 and 85.94%, respectively. There were statistically deferences between the fexofenadine group and cetirizine group (P<0.05). One hundred and forty-four patients with CIU entered the trial. Of the 144 patients, 67 receiving fexofenadine and 68 receiving cetirizine were included in PPS. The symptoms score reducing index and overall effective rate in fexofenadine group were 0.771±0.269 and 80.60%, recpectively. There were no marked differences between the two groups (P>0.05). There were no serious adverse reactions in the two groups. The incidence of adverse reactions in the fexofenadine and cetirizine groups was 17.6% and 16.9%, respectively, and there were no significantstastistically deferences between the two groups (P>0.05). The manifestations of adverse reactions in the two groups were similar, and the main of them was drowsiness and dry mouth. There were no obvious changes of ECG after dosing in the two groups, and no significant differences of QTc before and after dosing between the two groups (P>0.05). Conclusion: Fexofenadine is an effective and safe medication for treating seasonal allergic rhinitis and chronic idiopathic urticaria.
  • 调查研究
    Xing Yuqi;Zhang Yuqiu;Shi Na
    . 2005, 7(2): 97-100.
    Objective: To investigate adverse reactions caused by Ciwujia injection. Methods:Literature was retrieved from domestic medical journals 1994-2003, and 103 cases with the adverse effects in 75 papers were analysed. Results: The adverse effects were mainly anaphylactic shock (33.98%), then systemic reactions and disorders in skin and respiratory system. Conclusion: Allergy is the common adverse reaction to Ciwujai injection and close attention should be paid to it in clinical practice.
  • 调查研究
    Fang Yueping
    . 2002, 4(4): 223-225.
    Objective: To understand the effect of aminoglycosides on kidney function in the elderly. Method: 24 cases in our hospital were retrospectively analyzed, who were under aminoglycosides treatment of different diseases in past ten years. Results: All 24 elderly patients presented renal insufficiency in varying degrees, and two of them died. Conclusion: For the elderly aminoglycosides should be administrated in a way of lower dose or longer interval between dosing.
  • Wang Quan, Tang Huaying, Wang Bing, Li Jinfeng
    Adverse Drug Reactions Journal. 2023, 25(4): 255-256. https://doi.org/10.3760/cma.j.cn114015-20220321-00221
    A 62-year-old male patient with esophageal squamous cell carcinoma received immunotherapy combined with chemotherapy regimen (intravenous infusions of tislelizumab 200-mg on day 1, paclitaxel liposome 240-mg and nedaplatin 120-mg on day 2, 21 days as a cycle) for a total of 4 cycles. The patient′s condition was partially relieved. Then the treatment was changed to intravenous infusion of tislelizumab 200-mg on day 1 and tegafur, gimeracil and oteracil potassium 40-mg in the morning and 60-mg in the evening by mouth from the first day to the 14th day, 21 days as a cycle. Only one cycle was given. After the last treatment (the 98th day of immunotherapy combined with chemotherapy), the patient developed acute muscle weakness, sensory impairment, and decreased tendon reflexes. Nerve conduction and electromyography showed peripheral nerve damage in the limbs. Peripheral neuropathy caused by tislelizumab was considered. The patient received the treatments of methylprednisolone sodium succinate, mecobalamin, and vitamin B1. Nine days later, his symptom of myasthenic was improved, and pain and warm sensation was recovered gradually. Since then, the patient had not been treated with immunotherapy.
  • Chen Yanhao, Zhou Xiaobin, Fan Shuang, Wang Xiaodong, Duan Liwei
    Adverse Drug Reactions Journal. 2022, 24(9): 490-491. https://doi.org/10.3760/cma.j.cn114015-20220610-00513
    A 62-year-old female osteoporosis patient received alendronate sodium 70-mg orally once a week (taking the drug 30-minutes before breakfast with plenty of water and keeping upright during and after taking drug for a while). After taking the drug for 3 times, the patient developed retrosternal pain on swallowing with occasional acid aversion and epigastric dull pain. Gastroscopy showed multiple shallow ulcers, with yellow and white fur on the surface, in the esophagus 20-cm to 37-cm from the incisors. Esophagitis was considered, which might be related to alendronate sodium. Alendronate was stopped, and the treatments of acid suppression, mucosal repair, proper rehydration, and total liquid intake were given. Two days later, the stabbing pain behind the sternum was relieved; 7 days later, the pain was obviously relieved and symptoms of the acid aversion and epigastric dull pain disappeared; 1 month later, the retrosternal pain on swallowing disappeared.
  • Liu Min, Miao Wei, Zhang Chao, et al
    Adverse Drug Reactions Journal. 2021, 23(6): 285-292. https://doi.org/10.3760/cma.j.cn114015-20210302-00248
    Kidney cancer usually requires multidisciplinary individualized treatments. No matter what kind of treatment, drugs are essential. According to the "six-step process" (prescription legitimacy review, patient basic information evaluation review, treatment protocol review, organ function and laboratory index review, pretreatment review, and unconventional prescription review) in prescription review proposed by the anti-tumor drug prescription review expert group and referring to domestic and foreign kidney cancer guidelines and drug instructions in recent years, this consensus selects 9 targeted drugs and 4 immunotherapeutic drugs that are currently commonly used in China and elaborates the key review points in patient basic information evaluation review, treatment protocol review, and organ function and laboratory index review of kidney cancer drug treatment, in order to provide reference for clinical front-line pharmacists to review prescriptions of kidney cancer patients and promote rational drug use in clinic.
  • Wang Xing
    . 2017, 19(4): 282.
    Thrombocytopenia is a severe adverse reaction of vancomycin, which can cause hemorrhagic death. The pathogenesis of vancomycin induced thrombocytopenia (VIT) is not clear, and most studies suggest that VIT is related to vancomycin-dependent antiplatelet antibodies IgG and IgM. In vitro studies, it was found that vancomycin induced a series of changes in human platelets, resulting in activation, apoptosis, and reduction of platelets. Clinical manifestations of VIT are various degrees of bleeding. If patient was diagnosed with VIT after ruling out the influencing factors of other diseases or drugs, drug treatment should be promptly withdrawn or changed, and in severe cases, platelets transfusion, corticosteroids, immunoglobulins, rituximab, and hemodialysis should be considered.
  • 调查研究
    Luan Hong;Li Linfeng
    . 2002, 4(5): 298-301.
    Objective: To clarify the drug- induced eruption and its relation to fever and hepatorenal damage. Method: 173 inpa-tients who developed eruption from January 1996 to December 2000 were investigated. Results: 23 drugs were suspected of inducing eruption, including penicillins responsible for 86 cases (49.7% ), antipyretic- analgesics for 17 cases (9.8% ), sulfonamides for 15 cases (8.7% ), and traditional Chinese patent medicines for 11 cases (6.4% ) . The drug eruption could be divided into three patterns: exanthem, erythema multiforme and urticaria. Eruption was combined with fever or hepatorenal damage in 29.5% and 44.5% of 173 cases respectively. Conclusion: Penicillins seem to be the main factor in association with drug eruption, followed by antipyretic- analgesics, sulfonamides and traditional Chinese patent medicines.
  • Wu Shiqi, Zheng Chunlei, Nie Fengyu, Yan Suying, Zhang Qingxia
    Adverse Drug Reactions Journal. 2024, 26(6): 369-375. https://doi.org/10.3760/cma.j.cn114015-20231204-00858
    The "Top 10 drug tips for the public in 2023" issued by the Chinese Pharmaceutical Association emphasizes the importance of drinking water correctly to the safety and efficacy of drugs. Each drug has an optimal amount of drinking water, and only the appropriate amount can ensure the efficacy and avoid adverse reactions. According to UpToDate clinical consultant, Micromedex, MCDEX evidence-based databases and the drug labels of the US FDA and the European Medicines Agency, a total of 164 drugs in 20 categories, including drugs for metabolism and endocrine system, anti-infective drugs, anti-tumor drugs, etc., were labeled with the recommendation of adequate water intake. Here we summarize the above-mentioned drugs and their recommended water intake. The common reasons to drink enough water include preventing esophageal and gastric injury, preventing kidney injury, preventing dehydration, water and electrolyte disorders, preventing constipation, reducing bladder toxicity, reducing radiation damage, and promoting stone discharge. In addition, different people have different requirements for the amount of water when taking medicine. Mastering the correct amount of water is conducive to controlling the disease and reducing the adverse drug events.
  • Wu Xiaoping, Sun Xiaojing, Li Jinfeng
    Adverse Drug Reactions Journal. 2021, 23(7): 381-383. https://doi.org/10.3760/cma.j.cn114015-20210118-00076
    A 52-year-old male patient took one compound paracetamol and amantadine hydrochloride capsule (each capsule contains 250-mg acetaminophen, 100-mg amantadine hydrochloride, 2-mg chlorphenamine maleate, 10-mg artificial bezoar, and 15-mg caffeine) by himself for a cold. Half a day after the medication, the patient developed erythema with itching on the back. The next day the rash worsened and spread throughout the body, involving the mouth, eyes, and scrotal mucosa. Then the skin rash developed into big herpes with epidermal sloughing, and the area of skin damage reached to 90%, accompanied by mild liver injury and blood glucose rise. Epidermolysis bullosa type eruption was diagnosed. High-dose glucocorticoids, immunoglobulins, and symptomatic and supportive treatments were given and her skin lesions largely recovered 3 weeks later. The patient′s epidermolysis bullosa type eruption was consi- dered to be probably related to the acetaminophen in compound paracetamol and amantadine hydrochloride capsules.
  • Ge Mengjia, Chen Ken, Ma Qingbian, Yi Zhanmiao, Zhai Suodi
    . 2016, 18(6): 405.
    ObjectiveTo evaluate the risk factors for thrombocytopenia related to linezolid (LZD) comprehensively.MethodsThe related databases were electronically searched for the case-control studies about risk factors for LZD-associated thrombocytopenia from the inception to June 2016. The quality of the literature which was enrolled into the Meta-analysis evaluated by Newcastle-Ottawa Quality Assessment Scale (NOS), and then Meta-analysis was conducted using RevMan 5.3 software. The results are presented as odds risk (OR) and 95% confidence interval (CI).ResultsA total of 25 studies involving 4 279 patients were entered, including 1 335 in the thrombocytopenia group and 2 944 in the  none thrombocytopenia group. The NOS scores of all literature were greater than or equal to 7. The result of Meta-analysis showed that, the baseline platelet count < 200×109/L (OR=3.64, 95%CI: 1.60-8.30, P=0.002), body weight <50 kg (OR=2.44, 95%CI: 1.79-3.34, P< 0.001), creatinine clearance<30 ml/min (OR=1.85, 95%CI: 1.29-2.67, P< 0.001) , duration of LZD therapy > 14 days (OR=1.76, 95%CI: 1.17-2.65, P=0.006) and age≥65 years (OR=1.54, 95%CI: 1.03-2.31, P=0.04) were identified as significant risk factors for LZD-associated thrombocytopenia.ConclusionCurrent evidence shows that the severe damage to renal function, low baseline platelet count, low body weight, long-term LZD administration and advanced age are risk factors of LZD-related thrombocytopenia.
  • 综述
    . 2001, 3(2): 73-79.
    本文阐述了血管紧张素转换酶抑制剂(AcEI)的作用机制、分类、药动学与临床应用,为合理选用ACEI提供参考。并参阅国内外相关文献,予以分析和归纳,对其作用特点及不良反应加以综述。ACEI是一类新型治疗高血压和充血性心衰的药物,合理选用,可以获得很好的治疗效果。
  • Zhang Jingyuan, Bai Yuxia, Han Sheng, Jiao Ligong, Guan Xiaodong, Shi Luwen
    . 2016, 18(6): 412.
    ObjectiveTo detect adverse drug reaction (ADR) signals using data mining algorithm and explore its application value.MethodsReports on adverse reactions induced by anti-infective drugs in National centor for ADR monitoring from January 2009 to December 2013 were collected and potential ADR risk signals were detected using proportional reporting ratio method (PRR), reporting odds ratio method (ROR), Medicines and Healthcare Products Regulatory Agency method (MHRA), Bayesian confidence propagation neural network method (BCPNN), and multi-item gamma Poisson shrinker method (MGPS). The results of detection using the above-mentioned 5 signal detection methods were compared.ResultsA total of 35 807 ADR reports induced by anti-infective drugs were collected, 35 759 effective reports were entered, and 834 suspected drugs were involved. In the 35 759 reports, 464 kinds of ADR were defined according to lowest level term and 21 kinds of ADR were defined according to system/organ classification. After the data cleaning, splitting, and encoding process, 6 620 reports containing suspected drug-adverse reaction combination were acquired. There were 3 966 reports (59.91%) in which suspected drug-adverse reaction combination appeared once, 937 reports (14.15%)  in which suspected drug-adverse reaction combination appeared twice, and 1 717  reports (25.94%) in which suspicious drug-adverse reaction combination appeared more than thrice. The number of ADR signals detected using PRR, ROR, MGPS, BCPNN, and MHRA was 651, 614, 306, 75, and 57, respectively; the categories of drugs were 194, 168, 124, 34 and 40, respectively; ADR types were 139, 139, 121, 35, and 40,  respectively. In the top ten risk signals, azithromycin-nausea were detected by the 5 signal detection methods, levofloxacin-pruritus were detected by PRR, ROR, MHRA, and BCPNN. The top ten signals detected by PRR were totally same as those by ROR and signals detected by other methods were various.ConclusionsPotential risk signals in ADR reports could be detected systematically and automatically using PRR, ROR, MGPS, BCPNN, and MHRA. However, each method has its own advantage and disadvantage and should be applied according to the actual situation and demand.
  • 综述
    . 2000, 2(2): 80-83.
    大环内酯类抗生素的心脏毒性主要表现为QT间期延长和尖端扭转型室性心动过速,临床上可出现昏迷和猝死,以红霉素诱发为多,这是大环内酯类抗生素的一种特殊类型的不良反应。其发生机制是延长心肌动作电位时间,诱发心脏浦肯野纤维的早期后除极。为减少或避免心脏毒性的发生,临床医师在应用本类药物前需了解其诱发心脏毒性的可能性,根据患者病情和合用药物情况谨慎选药,用药期间注意观察,必要时监测心电图,一旦发生心脏毒性应采取积极治疗措施。
  • Niu Ziran, Sun Yihong, Luo He, Mao Min
    Adverse Drug Reactions Journal. 2023, 25(8): 511-512. https://doi.org/10.3760/cma.j.cn114015-20220801-00702
    A 78-year-old female patient with atrial fibrillation developed tarry stools after regularly taking dronedarone, metoprolol, and rivaroxaban for 3 months. The patient stopped using rivaroxa- ban by herself for 7 days, and her black stools was gradually improved. After taking rivaroxaban again for 1 month, black stools appeared again, accompanied by fatigue, dizziness, and amaurosis fugax. Her blood pres- sure was 90/50-mmHg, heart rate was 80 beats/min, and hemoglobin was 55-g/L. Rivaroxaban was discon- tinued again and supportive treatments such as soft food, acid suppression, fluid replacement, and blood transfusion were given. After 3 days of treatments, the symptoms of fatigue were improved significantly, and no amaurosis recurred when sitting up. Hemoglobin was 75-g/L. After 6 days of treatments, the patient dis- charged formed yellow soft stools. After excluding gastrointestinal tumors through gastroscopy and tumor mar- ker examination, it was considered that the interaction of dronedarone and rivaroxaban caused the increase of rivaroxaban plasma concentration, which resulted in gastrointestinal bleeding in the patient. The patient′s anticoagulant medication was changed to dabigatran etexilate, and no gastrointestinal bleeding occurred.
  • Deng Xiaoqin, Chen Qiong, Shen Dongfang, Hu Yin, Tan Helang
    Adverse Drug Reactions Journal. 2021, 23(8): 438-440. https://doi.org/10.3760/cma.j.cn114015-20201222-01268
    A 32-year-old male patient with hyperplasia of mammary glands took 5 Rupishu tablets (乳癖舒片) orally thrice daily by himself for about 2 years. Due to the poor treatment effect, he received additional 7 Xiaojin capsules orally twice daily according to the doctor′s advice. The patient′s liver function was normal during the monotherapy with Rupishu tablets. After 50 days of medication with the 2 drugs, the patient developed dark urine and yellowish skin and pruritus. Twelve days later, laboratory tests showed alanine aminotransferase (ALT) 1-068-U/L, aspartate aminotransferase (AST) 562-U/L, total bilirubin (TBil) 106.9-μmol/L, direct bilirubin (DBil) 84-μmol/L, and alkaline phosphatase (ALP) 175-U/L. He was diagnosed as having severe drug-induced liver injury, which was considered to be associated with Xiaojin capsules. Then both drugs were discontinued. Magnesium isoglycyrrhizinate injection and adenosylmethionine for injection were given for liver protection. Twelve days later, laboratory tests showed ALT 163-U/L, AST 52-U/L, TBil 36.1μmol/L, DBil 21.7μmol/L, and ALP 142-U/L. After that, the patient took the above 2 drugs by himself again. Twenty days later, the symptoms above-mentioned and abnormal liver function recurred. Xiaojin capsules were stopped and anti-inflammatory and liver-protective treatments were given. Twenty-three days later, laboratory tests showed ALT 25-U/L, AST 19-U/L, TBil 14.3-μmol/L, DBil 3.6-μmol/L, and ALP 76-U/L.
  • Yang Shaoying, Wang Bin, Fu Linyu, Zhang Chunping
    Adverse Drug Reactions Journal. 2020, 22(11): 652-653. https://doi.org/10.3760/cma.j.cn114015-20200113-00040
    A 70-year-old male patient with type 2 diabetes mellitus was treated with sitagliptin phosphate (sitagliptin) on the basis of previous oral metformin hydrochloride due to poor glycemic control. After 16 days of medication, the patient developed erythema and blisters with itching on the skin of the limbs. Laboratory tests showed that the white blood cell count was 12.2×109/L, neutrophil count was 8.5×109/L, and eosinophil count was 4.56×109/L. Histopathological examination of the skin lesion showed blisters under the epidermis, intact epidermis at the top of the blisters, dermal papillae at the bottom of the blisters, serous fluid and eosinophils in the blisters, and slight infiltration of eosinophils in the superficial dermis under the blisters. Bullous pemphigoid was diagnosed, which was considered to be related to sitagliptin. Therefore, the drug was discontinued. One week later, erythema and blisters gradually disappeared and no erythema or blisters recured.
  • 调查研究
    Zhou Jian;Guo Daihong;He Peihong
    . 2002, 4(6): 368-371.
    Objective: To discuss the adverse reactions caused by traditional Chinese medicines(TCM). Method: 142 ADR reports from PLA ADR Database 2001 were used for statistical analysis. Results: The ADR frequency was increased with involement of many kinds of TCM, mostly by injection. Conclusion: Caution should be advised in administering TCM to patients because of the annual rise of its adverse reactions.
  • 安全用药
    . 2003, 5(1): 26-28.
  • 专题讲座
    . 2004, 6(3): 174-176.
  • Qian Yafang1, Ling Chunyan2
    Adverse Drug Reactions Journal. 2020, 22(2): 105-106. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.009
    A 63-year-old female patient received gemcitabine (1.2 g by an IV infusion on the first day) and carboplatin combination chemotherapy (500 mg by an IV infusion on the second day) because of postoperative recurrence of ovarian cancer. After finishing the first chemotherapy, the patient had slight edema and stabbing pain of both legs, and the skin from ankle to the middle of both legs gradually turned reddish. Then the stabbing pain and edema were gradually relieved and the epidermis was gradually thickened. After finishing the second chemotherapy, the skin stabbing pain and edema of both lower extremities were aggravated. During the interval of chemotherapy, the stabbing pain and edema were gradually reduced, but the skin of her legs gradually turned dark brown, the epidermis became thick and hard, showing typical scleroderma-like changes. After finishing the third chemotherapy, the stabbing pain and edema of the lower extremities were aggravated again. Then the patient was lost to follow-up. No skin injury occurred during 6 times of paclitaxel liposome and carboplatin combination chemotherapy. So the scleroderma-like changes in the patient was considered to be related to gemcitabine.
  • Huang Liang, Zhang Lingli, Wang Zhiling, Liang Yi, Wang Mengya, Hu Zhiqiang, Quan Shuyan, Zhang Zhihui
    . 2016, 18(2): 88.
    ObjectiveTo evaluate the safety of domperidone in children.MethodsClinical studies involving domperidone used in children were searched from PubMed, Embase, Cochrane Library, Chinese Biology Medical disc, CNKI, VIP, and Wanfang Database. Adverse drug reaction information bulletins which were reported by WHO Pharmaceuticals Newsletter and National Center for adverse drug reaction monitoring were searched and adverse drug reactions (ADR)/adverse drug events (ADE) related to domperidone were collected. Websites of European Medicines Agency, Food and Drug Administration of United States, Medicines and Healthcare Products Regulatory Agency (MHRA), Health Canada, and Therapeutic Goods Administration were searched and information of risks and benefits related to domperidone treatment were collected. Randomized controlled trails (RCTs) were Meta-analyzed using RevMan 5.2 software and other data were descriptively analyzed. Correlation analysis of domperidone and adverse drug reactions was performed using evaluation criteria of WHO. Severity of ADR/ADE was evaluated using criteria CTCAE 4.03 of United States Department of Health and Human Services.ResultsA total of 9 RCTs, 1 cohort study, 4 self-controlled studies, and 24 case reports were entered in this study. Meta-analysis of 9 RCTs showed the following results. There were no statistical significance in the incidence of ADR in children between the domperidone group and the control groups of placebo, cisapride, and mosapride. The incidence of ADR in children in the domperidone group was lower than that in the metoclopramide (RR=0.44, 95%CI: 0.23-0.86, P=0.02), and higher than that in the Traditional Chinese Medicine group (RR=16.09, 95%CI: 2.01-129.04, P=0.01). There were no serious adverse events of domperidone reported in the 9 RCTs. It was showed in the self-controlled study that oral domperidone was associated with QTc prolongation in neonates. One hundred and one cases of ADR were reported in 24 case reports. Of them, 80 cases (79.2%) of ADR were mild-to-moderate (CTCAE grading 1-2), 21 cases (20.8%) of ADR were severe (CTCAE grading 3), and no ADR with CTCAE grading 4-5 was reported. The results of causality assessment on above mentioned 101 cases of ADR showed that 2 cases of ADR were associated with domperidone certainly, 76 were probably, 15 cases of ADR induced by drug overdose, and 2 cases induced by combination use of medicines that may cause the same adverse reactions. In April 2014, European Medicines Agency suggested to limit clinical indications and dosage of domperidone. In September 2014, MHRA of Britain announced that domperidone was no longer to use as over-the-counter.ConclusionsNo enough evidences to prove that the incidence of ADR induced by domperidone was higher than that by the placebo, other gastro-kinetic agents, and other conventional treatments in children. The risks of serious ADR occurrence existed in children with domperidone treatment.
  • 综述
    Zheng Shanshan;Mei Dan
    . 2014, 16(3): 171-4.
    Drug-induced delirium is a common drug-induced diseases, which is especially common in patients who are at advanced ages, with nervous system disease, experienced surgical operations or in critically ill patients. Drug-induced delirium is mainly associated with neurological dysfunction, which is caused by drugs affecting neurotransmitter synthesis, release and metabolism. Anticholinergic medicines and antidepressant medicines have a relatively high pathogenic rate. Rational use of drugs can avoid drug induced delirium. Besides, early diagnosis and treatment is quite important.
  • Dong Yuexin, Yu Dan, Shen Jianghua, Zhang Yan, Chu Yanqi
    Adverse Drug Reactions Journal. 2021, 23(10): 546-548. https://doi.org/10.3760/cma.j.cn114015-20201215-01241
    A 69-year-old male patient with retroperitoneal sarcoma received anlotinib capsules (12-mg orally once daily for 14 days, interruption for 7 days) and sintilimab injection (IV infusion of 200-mg on the first day) and 21 days was a cycle. He had no history of diarrhea and previous enteroscopy showed no obvious abnormality. So the diarrhea, which occurred after 18 days of treatments, was considered to be related to the combination use of anlotinib capsules and sintilimab injection. Above 2 drugs were stopped and hormone and symptomatic treatments were given. Six days later, the patient′s diarrhea was improved, and enteroscopy showed colitis. Considering the primary disease, the patient was treated with oral anlotinib capsule monotherapy with the same dose as before. Two days later, the patient had diarrhea again, which was more serious than before, and the anlotinib capsules were stopped again. After 14 days of hormone shock therapy, anti-infection therapy, and symptomatic treatments, the patient′s diarrhea was improved.
  • 综述
    . 2003, 5(1): 1-4.
    干咳是血管紧张素转换酶抑制剂类药物一种常见的不良反应,对患者的服药依从性和生活质量具有一定的影响。女性较男性更易发生,除此之外未发现更特异的环境变量或行为因素可以解释该不良反应的发生。基础研究提示其发生机制可能涉及激肽系统、花生四烯酸通路等。已有的少数候选基因研究主要涉及血管紧张素转换酶基因和缓激肽β2受体基因等,但未得到一致的关联结果。今后的候选基因研究应该注意考虑基因与基因间、同一基因中不同变异位点间、以及性别与基因表达间的交互作用对干咳发生的影响。
  • Lyu Guanbo, Liu Chen, Wang Yuqin
    . 2015, 17(4): 241.
    ObjectiveTo analyze the contents related to elderly people in medication instructions of oral drugs commonly used in China.MethodsOral medicines in Department of Outpatient Pharmacy, Xuanwu Hospital of Capital Medical University were recorded using Electronic Management System of drugs and composition ratio of different kinds of drugs were calculated. The notes for elderly people in medicine instructions were extracted and compared with administration suggestion (risk points) of the same drugs described in 2012 edition of Beers Criteria.ResultsA total of 368 kinds of oral drugs in Department of Outpatient Pharmacy were collected. Of them, varieties of drugs for central nervous system ranked first (93 kinds, 25.3%), varieties of drugs for cardiovascular system ranked second (62, 16.8%), varieties of drugs for digestive system ranked third (38, 10.3%)。Of the 368 kinds of oral drugs, medication instructions of 259 drugs (70.4%) were marked with notes for elderly people; medication instructions of 75 drugs (20.4%) were marked that no related tests were performed, no reliable references were provided or not clear; medication instructions of 34 drugs (9.2%) were not marked. Eighty kinds of drugs which were used in Department of Outpatient Pharmacy in 2013 were included in 2012 Beers Criteria. Of them, 8 kinds of drugs (10.0%) were not marked notes for elderly people and other 72 kinds of drugs (90.0%) were marked. Compared with the 2012 edition of Beers Criteria, the 72 kinds of drugs used in Department of Outpatient Pharmacy were divided into 4 kinds of results: risk points were not marked (52.5%,42/80), risk points were different (25.0%,20/80), risk points were less than those marked in Beers Criteria (6.3%,5/80), and risk points were identical (6.3%, 5/80). ConclusionThe notes for elderly people in medication instructions of commonly used oral drugs in China need further improvement to ensure medication safety in elderly patients.
  • 论著
    Chen Linzhen;Feng Hongmei;Li Xiaosui
    . 2007, 9(5): 329-331.
    Objective:To investigate the drug resistance in Gram-negative bacilli producing AmpC enzyme and non-producing AmpC enzyme in our hospital.Methods:One hundred and thirty-one strains of Gram-negative bacilli were isolated from inpatient's samples of sputum,urine,wound secretion,blood,and vignal secretion.The susceptibility testing for 12 kinds of antibacterials was performed and their resistance rates were analysed.AmpC enzyme was examined by the method of three-dimensional test.Results:Of the 131 strains of Gram-negative bacilli,15 strains produced AmpC enzyme,accounting for 11.5%.The resistance rate of the strains producing AmpC enzyme were obviously greater than those of the strains non-producing enzyme.The resistance rates of Gram-negative bacilli to amoxicillin/clavulanate,cefoxitin,cefotaxime,and ceftriaxone were greater than those of imipenem,piperacillin/tazobactam,and cefepime.Conclusion:The antibacterials resistance in Gram-negative bacilli is associated with AmpC enzyme produced by them.Imipenem may be considered as the first choice for treating the infections caused by Gram-negative bacilli producing AmpC enzyme.
  • 综述
    . 1999, 1(1): 18-21.
    本文综述分析非甾体抗炎药物的不良反应和预防措施。其常见的不良反应有胃肠道损伤、肝肾功能损害、变态反应、血液系统异常及中枢神经系统反应等。临床医师和广大患者应严格掌握适应证和禁忌证,合理选用不良反应少的品种,避免大剂量长期应用,加用胃粘膜保护剂等,以期最大限度降低不良反应的发生
  • 安全用药
    . 2004, 6(1): 31-35.
    为了解可引起胃肠道不良反应的常用药物,经检索有关文献资料,对各类药物可能引起胃肠道不良反应的发病机制和临床特点进行分析。结果药物致胃肠道不良反应发病率较高,其并发症可威胁人的生命。因此,应积极开展用药监测,预防药物致胃肠道不良反应的发生,尽可能减轻患者病痛。
  • 病例报告
    Liang Aiqun
    . 2008, 10(6): 0-0.
    A 53-year-old woman with urinary tract infection received an IV infusion of ceftriaxone sodium 2 g dissolved in 100 ml of 0.9% sodium chloride. She had no history of heart disease and drug allergy previously. Twenty-nine minutes after the first infusion initiation, the woman presented with facial and hand flushing followed by frothing from the mouth and cardiopulmonary arrest. Cardiopulmonary resuscitation started immediately and she received IV dexamethasone, IV adrenalin, IV dopamine, closed chest cardiac compressions, endotracheal intubation, and assisted ventilation. But resuscitation was unsuccessful and she died 30 minutes later.
  • Li Yun, Li Bingsheng, Yuan Zhen, Liu Bin, Li Yixiu, Ao Jian'gen
    Adverse Drug Reactions Journal. 2023, 25(10): 614-621. https://doi.org/10.3760/cma.j.cn114015-20221227-01184
    Objective To systematically evaluate the efficacy and safety of ixazomib in patients with relapsed or refractory multiple myeloma (RRMM) in the real world. Methods Relevant databases at home and abroad were searched (up to April 2022), and the literature on real-world studies of ixazomib in the treatment of RRMM was collected. The quality of the literature was evaluated with the methodological index for non-randomized studies (MINORS) scale. Data such as the effectiveness rate and incidence of adverse events in RRMM patients treated with ixazomib were extracted. The effectiveness indicators included the overall response rate (ORR), very good partial response or better (≥VGPR) rate and median progression-free survival (PFS). The safety indicators included the incidence of adverse events (AEs) and the rate of treatment termination due to AEs, etc. Stata 13.0-software was used for meta-analysis of single proportions, and the occurrence of major adverse events was analyzed by descriptive statistics. Results A total of 12-studies were entered, including 1-006 patients. The quality evaluation results showed that all of the 12-studies were with high quality. The meta-analysis of single proportions showed that ORR of ixazomib in the treatment of RRMM was 65%[95% confidence interval (CI): 58%-72%], ≥VGPR rate was 32% (95%CI: 25%-38%), the median PFS was 21.73 (95%CI: 14.37-29.08) months, the incidence of ≥ grade 3 AEs was 39% (95%CI: 24%-55%), and the incidence of treatment termination due to AEs was 6% (95%CI: 3%-10%). AEs with an incidence of ≥10% included neutropenia, thrombocytopenia, infection, anemia, diarrhea, fatigue, peripheral neuropathy, rashes, and bone pain. Conclusion In the real world, the efficacy of ixazomib in the treatment of RRMM is lower than that in clinical trials, but the safety is similar.
  • Chen Hongxu, Wu Qing
    Adverse Drug Reactions Journal. 2022, 24(7): 384-387. https://doi.org/10.3760/cma.j.cn114015-20210119-00050
    A 44-year-old female patient was treated with docetaxel and carboplatin chemotherapy for cervical cancer and dexamethasone 7.5-mg twice daily was given the day before and on days 1 and 2 of chemotherapy. No adverse reactions occurred in the first 3 courses. No abnormality was found in laboratory tests, color Doppler echocardiography, or CT examination of chest and abdomen before the 4th chemotherapy. On day 3 and 4 of the 4th chemotherapy, the patient felt mild nausea, which was relieved after intravenous injection of metoclopramide; on day 5, she suffered sudden upper abdominal distension, pain, and discomfort, accompanied by nausea and vomiting. Chest and abdominal CT examination indicated a large amount of peritoneal effusion. Renal function tests showed blood urea 10.29-mmol/L and blood creatinine 215-μmol/L. Tumor peritoneal metastasis, acute abdomen, cardiac insufficiency, hypoproteinemia and other reasons were excluded, and the peritoneal effusion caused by docetaxel was considered, which then induced prerenal acute kidney injury. Peritoneal effusion was extracted through peritoneal puncture and glucocorticoid and diuretic therapy were given. On day 8 of chemotherapy, renal function of the patient was normal; on day 9, her abdominal distention and pain were obviously relieved; on day 11, abdominal ultrasonography showed no obvious mass or liquid dark area. After that, the patient received traditional Chinese medicine for cervical cancer and chest and abdomen CT examination was repeated every 3-6 months. Blood routine examination and liver and kidney function showed no abnormality in subsequent tests.
  • 安全用药
    . 2005, 7(3): 188-191.
    为了解静脉用免疫球蛋白(IVIG)在临床应用的不良反应,我们检索并归纳国内外相关文献资料,并对免疫球蛋白的安全性问题进行综合分析。静脉用免疫球蛋白在临床应用过程中,除能引起常见的一般反应、过敏反应外,还可导致神经、血液、泌尿、循环、呼吸系统的毒副作用,并可造成病毒传播等。静脉用免疫球蛋白现今被公认为临床使用最安全的血液制品,但不应忽视其可能引致的临床不良反应。
  • 调查研究
    Zhao Huanyu;Li Jiajing
    . 2002, 4(6): 361-364.
    Objective: To survey the adverse reactions caused by anti-infective drugs for their safe use in clinical practice. Method: ADR cases were analysed in Beijing Tongren Hospital during the last eight years. Results: 513 ADR cases were associated with 72 anti-infective drags, commonly aminoglycosides(114 cases, 22.22%), penicillins (107 cases, 20.86%), cephalosporins (97 cases, 18.91%) and quinolones(86 cases, 16.76%). Most of ADR were found in the skin and its appendages, nervous system and digestive system. Conclusion: Rational use of anti-infective drugs should be taken to decrease the occurrence of adverse reactions.
  • 学术研讨
    . 2006, 8(5): 329-331.
    儿童处于生长发育的特殊阶段,钙是最易缺乏的营养素,钙摄入不足易引起维生素D缺乏性佝偻病,但补钙过量也可造成严重危害。近年来,儿童如何补钙一直存在争议。怎样选择含钙食品和钙剂,是否需要补充维生素D以及如何补充维生素D等问题是争议的焦点。本文对钙剂吸收、预防维生素D缺乏性佝偻病、防止补钙过量,正确选择钙剂、维生素D,补钙与铅中毒等问题进行探讨,希望儿童能科学合理的补充钙剂。
  • 调查研究
    Zhou Ying;Lu Yunlan
    . 2000, 2(2): 91-94.
    Cases with liver damage induced by flutamide and bicalutamide were collected from MEDLINE of 1990-1999 and our hospital. The two drugs' adverse reactions of liver damage happened in some countries and their adoption of appropriate measures are presented in this paper. It is suggested that patients with severe liver damage should not take flutamide and bicalutamide and that individuals with poor liver function or hepatitis history take them cautiously while examined for LFT, once a month at least.
  • Ding Zheng, Zheng Yingli
    Adverse Drug Reactions Journal. 2022, 24(7): 337-340. https://doi.org/10.3760/cma.j.cn114015-20220509-00403
    Direct oral anticoagulants (DOACs) are recommended as first-line therapy in patients with atrial fibrillation and venous thromboembolic diseases in relevant guidelines at home and abroad. Compared with warfarin, DOACs have relatively fixed dose, fewer drug interactions, and no need of routine therapeutic drug monitoring in clinic. DOACs bring much convenience to anticoagulant therapy, but they also raise a series of new medication safety challenges. Pharmacists should ensure the safe use of DOAC through improving corresponding pharmaceutical care mechanism, such as assisting doctors to improve the suitability of dose in prescription, standardizing laboratory monitoring process, setting up early warning of potential drug interaction, and strengthening anticoagulant conversion and perioperative anticoagulant therapy management. In the post-coronavirus disease 2019 era, incorporating DOACs into the standardized management at anticoagulation clinics is an important work extension of the traditional anticoagulation clinics and may reduce the risk of exposure to the novel coronavirus. In addition, considering the limit in labour and work energy of clinical pharmacists, the application of DOAC-related clinical decision support system may help improve the appropriateness of prescription and reduce the adverse drug events.
  • Cong Duanduan, Xue Wei, Liu Xiaohui, Li Kexin, Hu Xin
    Adverse Drug Reactions Journal. 2022, 24(6): 281-283. https://doi.org/10.3760/cma.j.cn114015-20220606-00495
    Since healthy volunteers usually have no expected direct clinical benefits in clinical trial, it is particularly important to fully assess the risks and carry out safety monitoring in all links of the trial in combination with their group characteristics. The risk points for healthy volunteers to participate in clinical trials lie in the aspects of trial drugs, clinical trial design, and trial implementation process. The safety and rights of healthy volunteers should be better protected by implementing the Good Pharmacovigilance Practices, improving the level of risk management, enhancing the transparency of clinical trial results, and carrying out relevant risk management research.
  • Lao Haiyan, Liu Shuangxin, Ma Jianchao, Pan Yuhua, Huo Qihua, Yang Min
    . 2016, 18(1): 15.
    ObjectiveTo investigate the effect of cyclosporine on serum creatinine (Scr) levels in patients with nephrotic syndrome.MethodsThe medical record data of patients, who received the treatment with cyclosporine, diagnosed as nephrotic syndrome by renal biopsy, and hospitalized in Guangdong General Hospital from April 2010 to June 2014, were collected and retrospectively studied. Before treatment, all patients′ Scr were less than 200 μmol/L. Increase of the Scr levels by more than 10%-20%, 21%-30%, and >30% of the baseline value were defined as mild, moderate, and severe increase, respectively (severe increase of Scr is considered as renal toxicity). Changes of Scr levels before and after cyclosporine treatment, relationship between the blood concentration of cyclosporine and increase of Scr were analyzed.ResultsA total of 78 patients were enrolled in this study. Of them, 52 were males and 26 were females with age from 14 to 77 years and an average age was (43±20) years. From the results of pathological types, 14 cases had minor lesion, 12 cases had focal segmental glomerulosclerosis, and 52 cases had membranous nephropathy. The average level of Scr before treatment was (94±48) μmol/L. After one week treatment, the average level of Scr in 78 patients was (103±61) μmol/L and the difference was statistically significant compared with that before treatment (P<0.05). Of the 78 patients, 30 cases (38.5%) had increased Scr levels; mild, moderate, and severe increase was seen in 9, 11 and 10 patients respectively. The incidence of renal toxicity was 12.8% (10/78). There were no statistically significant differences in Scr levels between 1, 3, and 6 months of treatment (all P> 0.05). In patients with different pathological types including minor lesion, focal segmental glomerulosclerosis, and membranous nephropathy, the incidence of Scr increase were 28.6% (4/14), 33.3% (4/12), and 42.3% (22/52), respectively (P>0.05) and the incidence rate of renal toxicity were 7.1% (1/14), 16.7% (2/12), and 13.5% (7/52), respectively (P>0.05). The incidence of increase of Scr rose gradually with the increase of cyclospo-rine concentration. In patients with cyclosporine concentrations of ≤200 ng/ml and >200 ng/ml, the incidence of increase or severe increase of Scr were 32.2% (19/59) and 57.9%, respectively (χ2=4.008,P=0.045); the incidence of renal toxicity was 8.5% (5/59) and 26.3% (5/19), respectively (P>0.05).ConclusionsSerum creatinine may increase mildly to moderately at early stage of treatment with cyclosporine in patients with nephrotic syndrome and could be controlled effectively with timely intervention. The increase of Scr may be related to blood cyclosporin concentration. Blood cyclosporin concentration should be monitored regularly during the treatment and the drug dosage should be adjusted according to the result of monitoring.
  • Wu Shujuan, Gu Ermin, Ye Xiaolan
    Adverse Drug Reactions Journal. 2021, 23(1): 45-46. https://doi.org/10.3760/cma.j.cn114015-20200316-00278
    A 58-year-old male patient received quadruple therapy with amoxicillin 1 g, furazo- lidone 0.1 g, rabeprazole 20-mg, and bismuth potassium citrate 0.6 g twice daily for Helicobacter pylori infection for 4 weeks. Seven days after drug withdrawal, the laboratory tests showed serum creatinine (Scr) 469-μmol/L and blood urea nitrogen (BUN) 19.2-mmol/L. Renal biopsy showed acute tubular injury. The Scr level was 78-μmol/L in the physical examination of 6 months ago. Acute kidney injury was considered to be associated with the quadruple therapy. Methylprednisolone, rebamipide, and calcium carbonate were given orally. Four weeks later, the laboratory tests showed Scr 171-μmol/L and BUN 14.4-mmol/L and the above treatments were continued; 12 weeks later, his Scr was 140-μmol/L and BUN was 11.4-mmol/L.
  • 调查研究
    Zhang Lina;Shi Huiqing;Zeng Renjie
    . 2004, 6(6): 381-383.
    Objective: To analyse the characteristics of hemolysis induced by puerarin injection. Methods: From domestic medical journals 1999-2003,16 hemolysis cases due to puerarin were collected and analysed. Results: These 16 cases comprised 12 males and 4 females, mostly over 60 years old. The dose of puerarin was 200 to 600 mg once daily and hemolysis occurred chiefly within 3-10 days of the first couse of treatment except 3 cases occurring during its re-administration. It seemed to be no difference to patients with or without a history of allergy. The main symptoms were arthralgia,generalized pain, rigor, fever and macroscopic hematuria. Hemoglobin in blood was reduced and hemoglobinuria was observed. The specific antibody for puerarin was detected with immunological test. Conclusion: Puerarin-induced hemolysis was related to many factors. Much attention should be paid in the clinical use of puerarin injection.
  • Feng Ye, Yang Huixia
    Adverse Drug Reactions Journal. 2021, 23(9): 453-455. https://doi.org/10.3760/cma.j.cn114015-20210917-01000
  • 论著
    Wu Xiaoling;Zhou Minhua;Deng Jianxiong
    . 2014, 16(5): 281-5.
    Objective To understand the effect of rational use of traditional Chinese patent medicines on medication safety.MethodsBy using cluster sampling method, the adverse drug reaction (ADR) reports about traditional Chinese patent medicines (including traditional Chinese medicine for injections) derived from the Center for ADR Monitoring of Guangdong from January 1st, 2011 to December 31st, 2011, were collected and retrospectively analyzed. The information of the patients′ gender, ages, primary diseases, the suspected drugs causing ADR, drug combination, and the situation of ADR occurrence were collected. The situation of irrational drug use in these reports at 7 aspects such as indications, syndrome differentiation treatment, medication methods, dosage, combination of traditional Chinese patent medicines, concomitant use of the traditional Chinese medicines and the Western medicines, and suitability of medication were analyzed according to the protocol of evaluation standards of traditional Chinese patent medicine prescription and the rate of irrational drug use were calculated.ResultsA total of 283 reports in accordance with the inclusion criteria were collected, which comprised 283 patients. Of them, 150 were male and 133 were female with ages from 2 months to 88 years and an average age was (44±23) years. The primary diseases ranking at the top three were respiratory system disease (71 patients), nervous system disease (45 patients), and musculoskeletal system disease (42 patients). The traditional Chinese patent medicines involved in these reports were mainly antipyretic-detoxicating agents, blood activating and stasis removing agents, and reinforcing agents. The rates of irrational drug use associated with indications, medication methods, dosage, combination of traditional Chinese patent medicines, concomitant use of the traditional Chinese medicines and the Western medicines, and suitability of medication were 27.2% (77/283), 6.0% (17/283), 7.1% (20/283), 5.3% (15/283), 6.7% (19/283), 0.7% (2/283), respectively. Fifteen patients′ medication (46.8%)did not fit the syndrome differentiation classification among the 32 reports whose differentiation of syndromes could be identified.ConclusionsThe irrational drug use has marked effect on medication safety of traditional Chinese patent medicines and maybe one of the important factors in relation to adverse reactions induced by traditional Chinese patent medicines. In clinical use of traditional Chinese patent medicines, syndrome differentiation treatment should be the primary principle, medication beyond the indications should be avoided, more attention should be paid to usage and dosage of the drugs, and combination of function-similar traditional Chinese patent medicines and pharmacological action-similar traditional Chinese and Western medicines should be used cautiously.
  • 调查研究
    Wen Weijing①;Liu Lingling①;Dou Xia①;Yang Jianfeng②;Bian Queqiao③;Zhu Xuejun①
    . 2005, 7(4): 259-262.
    Objective:To analyse the causative agents and the clinical features of drug eruption. Methods: The clinical data of 196 patients hospitalized for drug eruption in dermatology department from 1998 to 2003 were retrospectively analyzed. Results: The main causative agents were with antibiotics (96 case-times), followed by analgesics-antipyretics(27), traditional Chinese medicines(18)and sulfonamides(17).The most common causative drug was amoxycillin, and the most common form of drug eruption was exanthematous one. Conclusion: Antibiotics-induced eruption is common, and traditional Chinese medicine-induced eruption is increasing, so caution is need when using these products.
  • Sun Wenfang, Chen Jing, Ding Quan, Liu Yang
    Adverse Drug Reactions Journal. 2022, 24(5): 276-277. https://doi.org/10.3760/cma.j.cn114015-20211119-01177
    A 64-year-old male patient underwent gastroscopy for dizziness and bloody stool, showing bleeding gastric ulcer. After gastroscopy, he was treated with pantoprazole sodium for injection, Danggui Buxue oral liquid (当归补血口服液), and symptomatic and supportive treatments. The patient was gradually improved and had no hematemesis and melena stool. Laboratory tests showed total bilirubin (TBil) 9.9-μmol/l and direct bilirubin (DBil) 4.6-mmol/L. Four days later, rebamipide 0.1 g thrice daily orally was added. The next morning, the patient had soy sauce colored urine and yellowish skin and sclera. Laboratory tests showed TBil 81.4-μmol/l, DBil 8.9-mmol/L, and lactate dehydrogenase (LDH) 1-448-U/L. Hemolytic jaundice was considered, which might be related to rebamipide. Then rebamipide was stopped, the other drugs were continued, and treatments such as alkalization of urine (sodium bicarbonate 1 g thrice daily by mouth) and rehydration were given. Two days later, the urine color in the patient became lighter, the yellowish skin and sclera subsided, and laboratory tests showed TBil 43.1-μmol/l, DBil 11.2-mmol/L, and LDH 842-U/L.
  • 药源性疾病
    . 2006, 8(6): 442-446.
  • 调查研究
    Zhao Chen;Zhu Wei;Lian Shi
    . 2008, 10(5): 0-0.

    Objective: To understand the types of drug eruptions and their causative agents in order to help clinicians to diagnose and treat drug eruptions. Methods: The clinical data from outpatients between January 2002 and December 2007 were collected. The latent period, causative agents, type, treatment, and outcome of drug eruptions were analyzed retrospectively. Results: A total of 341 patients[165 men and 176 women aged 3~90 years, average age (45.67±19.98) years ] were enrolled in a study. Two hundred and ninety-eight patients of them had a certain latent period. The latent period from exposure to onset of symptoms was ≤1 week in 247 cases (82.89%),~2 weeks in 28 cases (9.40%) and >2 weeks in 23 cases (7.71%). Two hundred and ninetythree patients (85.92%) received monotherapy. The common agents causing drug eruptions were β-lactam antibiotics (68 cases, 32.2%), analgesicantipyretic agents (49 case, 16.72%), quinolones (32 cases, 10.92%), Chinese patent medicines (30 cases, 10.24%), and sulfonamides (29 cases, 9.90%). Other causative agents included cardiovascular agents, antiepileptics, biological products, sedatives and hypnotics. The types of drug eruptions were morbilliform or scarlatiniform exanthema (exanthematous eruption) (147 cases), urticaria (71 cases), fixed drug eruption (60 cases), erythema multiform (7 cases), purpuric eruption (4 cases), eczematid (2 cases), severe erythema multiform (1 case), and acneiform eruption (1 case). Exanthematous eruption is mainly caused by β-lactam antibiotics (49 cases), quinolones (18 cases), analgesic-antipyretic agents (18 cases) and Chinese patent medicines (16 cases). Urticaria is mainly caused by quinolones (10 case) . Fixed drug eruption is mainly caused by sulfonamides (28 cases) and analgesic-antipyretic drugs (22 cases). All the patients fully recovered after receiving antihistamines, corticosteroids and symptomatic and supportive treatment. Conclusion: The most common drug eruptions are exanthematous eruption, followed by urticaria and fixed drug eruption. The most common drugs that cause drug eruptions are β-lactam antibiotics, analgesic-antipyretic agents, quinolones, Chinese patent medicines, and sulfonamides.

  • 专题讲座
    . 2003, 5(5): 321-325.
  • Ni Beibei, Zhao Jun, Cao Zhanqi, Guo Qie, Xu Wen, Leng Ping
    Adverse Drug Reactions Journal. 2022, 24(5): 252-257. https://doi.org/10.3760/cma.j.cn114015-20211217-01269
    Objective To understand the clinical features of granulomatous hepatitis (GH) induced by intravesical instillation with Bacille Calmette-Guérin vaccine (BCG). Methods Case reports of GH which was confirmed by liver biopsy and induced by intravesical BCG therapy were collected by searching PubMed and Elsevier databases as of December 2021. The following information of patients inclu- ding general information, intravesical BCG situations (dose, times of instillation, traumatic catheterization occurrence), GH occurrence (onset time, clinical manifestations, laboratory tests and liver biopsy results), other adverse reactions, treatments, and outcomes were extracted and analyzed descriptively. Results A total of 23 patients, who were all male, were entered in the analysis, aged from 34 to 80 years with a median age of 66 years. The primary diseases were bladder cancer in 22 patients and ureteral carcinoma in 1 patient. The times of instillation until GH occurred were recorded in 19 patients. Of them, 2 patients had instillation once and the time was 16 at most. Ten patients had traumatic catheterization during the last instillation, inclu- ding hematuria in 7 patients, pain in 2 patients, and difficulty in urethral intubation in 1 patient. Time from the last instillation to the onset of GH was from 3 h to 440 days (≤7 days in 18 patients, 10, 14, 21, 180, and 440 days in 1 patient respectively) with a median time of 3 days. Among the 23 patients, 21-had fever, 12-had jaundice, 9 had hepatomegaly, 7 had fatigue, 5 had anorexia, 2 had weight loss, and 1 had night sweats; 12 manifested as GH alone and 11-had concomitant adverse reactions. Abnormal liver function appeared in 22 patients, mainly including elevated alkaline phosphatase and elevated aspartate aminotransferase (each in 17 patients). Mycobacterium bovis identification/culture results were recorded in 20 patients and 7 were positive. Liver biopsies showed noncaseating granuloma of epithelioid in 10 patients, noncaseating granuloma in 7 patients, epithelioid granuloma in 4 patients, and hepatic granuloma without details in 2 patients. After discontinuation of BCG instillations and treatments with anti-tuberculosis agents and/or corticosteroids, 22 patients were improved and 1 patient died of BCG sepsis and multiple organ failure. Conclusions GH usually occurs within 1 week after intravesical instillation with BCG and mainly manifests as fever, jaundice, hepatomegaly, and abnormal liver function, which may be accompanied by other adverse reactions related to BCG instillation. Liver biopsy can help the diagnosis. The prognosis is good after combination therapy with anti-tuberculosis agents and corticosteroids, but death may occur in severe cases.
  • Zhang Yunchen, Huang Wenhui, Wang Fangfang, Kong Lingdong, Chen Qiuhong
    Adverse Drug Reactions Journal. 2021, 23(9): 480-486. https://doi.org/10.3760/cma.j.cn114015-20210406-00420
    Objective To understand the clinical characteristics of serotonin syndrome (SS) induced by combined use of linezolid and serotonergic drugs. Methods Relevant databases at home and abroad as of February 2021 were searched and case reports of SS induced by linezolid combined with serotonergic drugs were collected. Clinical information including patients′ basic characteristics (gender, age, underlying disease, etc.), linezolid and serotonergic drugs application (medication reasons, usage and dosage, drug elution period, etc.), and the occurrence time, clinical manifestations, intervention measures, and outcomes of SS were extracted and analyzed by descriptive statistical method. Results A total of 50 patients derived from 46 literature were enrolled in the study, including 23 males and 27 females. Of them, 49 patients were aged from 23 to 98 years, and one patient was 4 years old. The reasons for using serotonergic drugs were mental illness (36 patients), pain (8 patients), and Parkinson′s disease (2 patients), etc.; the reasons for using linezolid were staphylococcal infection (24 patients), enterococcal infection (13 patients), and empirical anti-infection treatments (11 patients), etc. Among the 50 patients, 48 were treated with serotonergic drugs and then with linezolid, and 2 were treated with linezolid and then with serotonergic drugs; the drug washout period was not recorded in 44 patients and not long enough in the other 6 patients; the serotonergic drugs were given orally in 40 patients and by intravenous infusion in 10 patients; 35 patients had usage and dosage records, which were all in line with the requirements of drug labels; 27, 16, 5, and 2 patients were treated with 1, 2, 3, and 4 kinds of serotonergic drugs respectively, and the drugs used mainly were selective serotonin reuptake inhibitors, serotonergic drugs and norepinephrine reuptake inhibitors, tricyclic antidepressants, and opioids, etc. Except the administration route of linezolid was not mentioned in 12 patients, it was given by intravenous infusion in 27 patients and orally in 11 patients. The frequency of medication met the requirements of drug labels in 49 patients, and the medication frequency of one child was lower than that specified in the drug labels. SS occurred 3 hours to 20 days after combined use of drugs, mostly 1 to 5 days. The clinical manifestations were mental state change, autonomic nerve dysfunction, and neuromuscular dysfunction in 45, 47, and 45 patients, respectively. After discontinuation of linezolid and/or serotonergic drugs and receiving symptomatic treatments for 2 hours to 9 days, 43 patients were improved, 1 patient died of cardiac arrest after SS occurrence, and 6 patients died of the primary diseases after the symptoms of SS were controlled. Conclusions SS due to linezolid combined with serotonergic drugs mostly occurred 1 to 5 days after combined use of above 2 drugs, and the clinical manifestations were similar to SS induced by other reasons. After discontinuation of linezolid and serotonergic drugs and symptomatic and supportive treatments, the overall prognosis is acceptable, but serious SS can lead to death.
  • Lu Cuicui, Zhang Yahui, Yang Rui, Zhang Wen
    Adverse Drug Reactions Journal. 2020, 22(5): 313-314. https://doi.org/10.3760/cma.j.cn114015-20181017-01004
     A 51-year-old male patient received ibuprofen intermittently for loin and leg pain for 4 years and regularly (0.2 g, thrice daily) due to the aggravation of pain for 2 years. Then the patient developed nausea and vomiting. Laboratory tests showed red blood cell count 2.13×1012/L, hemoglobin (Hb) 59-g/L, serum creatinine (Scr) 897-μmol/L, uric acid 457-μmol/L, and urine protein (+). Abdominal CT scan showed that both kidneys were with reduced volume, uneven surface, and papillary calcification. The patient was diagnosed with chronic kidney disease stage 5. It was considered that the patient′s chronic kidney disease might be associated with long-term administration of ibuprofen, according to his medication history and clinical presentations. Ibuprofen was discontinued immediately and the patient was given symptomatic treatments including fasting, temporary hemodialysis via jugular vein cannulation, and remedying anemia. Meanwhile, the efficient vascular access was established for long-term hemodialysis. After 7 days, the patient was fed with liquid diet through nasal feeding tube and no symptoms like abdominal distention, nausea, or vomiting appeared. After 22 days, semi-fluid diet was given. After 27 days, his Scr was 531-mmol/L and Hb was 84-g/L.The patient was told not to take nephrotoxic drugs such as ibuprofen, and if necessary, oral acetaminophen (maximum daily dose ≤ 3 g) and analgesic patches for topical use were recommended.
  • 论著
    Gu Jianqing①;Zheng Hongliang②;Xue Weiguo③;Zhang Hongyu①
    . 2007, 9(3): 162-165.
    Objective: To compare the efficacy and safety of R-budesonide nasal spray in the treatment of allergic rhinitis with those of budesonide nasal spray. Methods: A multi-center, randomized, open and parallel-controlled clinical trail was performed. Two hundred and twenty-two patients with allergic rhinitis were assigned randomly into two groups: experimental group (110 cases) and control group (112 cases). The patients in the experimental group received R-budesonide nasal spray 50 μg(2 puffs) into each nostril twice daily and the patients in the control group received budesonide nasal spray 64 μg (1 puff) into each nostril twice daily. The duration of treatment in the two groups was 14 days. The clinical effects were evaluated according to the symptom score reducing index regarded as the main index and the improvement in quality of life after therapy regarded as the secondary index. Results: 0The symptom score reducing index, the improvement in quality of life, and the incidence of adverse reactions were similar among the experimental group compared with the comtrol group, that is, 0.78±0.24 vs 0.76±0.23, 96.4% vs 94.6%, and 13.6% vs 14.3%. Conclusion: R-budesonide nasal spray has the same efficacy and safety as budesonide nasal spray in the treatment of allergic rhinitis.
  • Yin Huanli, Huang Yuan, Chen Zhaoyang, Xu Ting
    Adverse Drug Reactions Journal. 2021, 23(2): 106-107. https://doi.org/10.3760/cma.j.cn114015-20200420-00434
    A 37-year-old male patient with acute myelomonocytic leukemia received cytarabine combined with idarubicin for 4 times. The patient did not develop rash or skin damage during the chemotherapy except for myelosuppression and vomiting. The patient developed slight itching on the extremities on the 4th day after the 5th intravenous infusion of idarubicin (20-mg once daily, on day 1) and cytarabine (1-900-mg once per 12-hours, on day 1 to 4), and no special treatment was given. On the 2nd day after finishing the chemotherapy, the patient developed obvious dark brown pigmentation on both cheeks and red papules on his back and bilateral waist, which was considered to be related to combination use of cytarabine and idarubicin. Chlorphenamine maleate 4-mg orally once per 12-hours, and IV infusions of 20% vitamin C injection 5-ml+0.9% sodium chloride injection 100 ml+10% calcium gluconate injection 10-ml once daily were given. Seven days later, the red papules on his back and waist disappeared; 24 days later, his facial pigmentation disappeared basically.
  • Liu fang, Zhang Xiaole, Zhu Zhu
  • 论著
    Zhang Qi;Peng Miaoguan;Jiang Peipei;Huang Yanping;Min Yunbing;Li Meizhong;Huang Jufang;Luo Jinhua;Wang Dan;Wang Ying;Liao Zhihong
    . 2008, 10(6): 387-5.
    Objective: To study on relationship between sulphonylureasinduced hypoglycemia and CYP2C9 genotype in patients with type 2 diabetes. Methods: The outpatients with type 2 diabetes receiving sulphonylureas treatment were enrolled in a study from November 2006 to May 2007. The patients’blood glucose levels and CYP2C9 genotype were measured. The relationship between hypoglycemia and CYP2C9 genotype was analyzed. Results: Of 146 patients with type 2 diabetes, 43 were males, 103 were females, and their ages were 23~79 years\[average age (62.5±12.4) years\]. All patients received sulphonylureas. The specific drugs and dosages were as follows: glipizide 5~10 mg/d, gliclazide 80~160 mg/d, sustainedrelease gliclazide 30~60 mg/d, glimepiride 0.5~2 mg/d, and glibenclamide 5~10 mg/d. Seventyfour cases of 146 patients developed hypoglycemia. Of the 74 cases, 19 were sulphonylureasinducedhypoglycemia and 55 were other factorinduced hypoglycemia (as a consequence of delayed meal, less intake of food, excessive exercises, and so on).Of the 146 patients, 13(8.9%) were CYP2C9*1/*3 genotype, and 7 of the 13 cases were in the hypoglycemia group, 6 were in the nonhypoglycemia group. Of 19 cases of sulphonylureasinduced hypoglycemia, 6 were CYP2C9*1/*3 genotype. Of 55 cases of other factorinduced hypoglycemia, 1 was CYP2C9*1/*3 genotype. There was a statistical difference in CYP2C9 genotype between the sulphonylureasinduced hypoglycemia group and the other factorinduced hypoglycemia group or the nonhypoglycemia group (P<0.05). Conclusion: Sulphonylureasinduced hypoglycemia occurring in patients with type 2 diabetes might link to CYP2C9 gene mutation (CYP2C9*1/*3).
  • 论著
    Zhang Hong;Deng Xiaohu;Zhang Yamei;Zhang Jianglin;Huang Feng
    . 2008, 10(6): 0-0.
    Objective: To observe the adverse reactions of etanercept in the treatment of ankylosing spondylitis (AS). Methods:A randomized, doubleblind, placebocontrolled parallel study was conducted. From April 2005 to January 2006, 52 patients with active ankylosing spondylitis were enrolled in the study, and randomly divided into the etanercept and placebo groups (26 patients in each group). The patients' average age in the etanercept group was (27.7±8.5) years, and in the placebo group was (29.7±8.1) years. The trial duration was 12 weeks. The first 6 weeks were a doubleblind phase and the second 6 weeks were an openlabel phase. During the doubleblind phase, the patients in the etanercept group received etanercept subcutaneously in a dose of 25 mg twice a week for 6 weeks and the patients in the placebo group received inactive substance subcutaneously in a dose of 25 mg twice a week for 6 weeks. During the openlabel phase, all the patients in both groups received etanercept subcutaneously in a dose of 25 mg twice a week for 6 weeks. Routine blood test was performed at week 0, 1, 2, 4, 6, 7, 8, 10, and 12, meanwhile the dermal lesion at the site of injections, the skin and its appendages reactions, infections, hematological disorders, liver enzyme levels, autoantibody response, and other adverse reactions were observed and analysed. Results: The incidence of adverse reactions in the etanercept and placebo groups was 23% and 38%, respectively; the difference was not statistically significant (P>0.05); no serious adverse reaction occurred. During the doubleblind phase, 26.9% of the patients in the etanercept group developed local dermal lesions characterized by redness and swelling, induration, and pruritus at the site of injections, and no case of such local dermal lesions was found in the placebo group; the difference between both groups was statistically significant (P<0.05). During the trial period, the incidence of the reactions at the site of injections was 34.6%. During the doubleblind phase, 6 patients (23.1%) in the etanercept group developed neutrocytopenia, but neutrocytopenia was not found in the placebo group; the difference between both groups was statistically significant (P<0.05). The difference in the other adverse reactions including upper respiratory tract infections (5 vs 7), skin reactions (6 vs 3), and increased liver enzyme levels (5 vs 8) between the etanercept and placebo groups was not statistically significant (all P>0.05). Conclusion: Etanercept is a relatively safe agent in treatment of ankylosing spondylitis.
  • 论著
    LI Xiao-ling;YAN Su-ying;WANG Yu-qin;ZHANG Qing-xia;WANG Ya-wei;SHEN Jiang-hua;LIU Chen
    . 2013, 15(2): 64-5.

    ObjectiveTo understand the current status of medication errors (ME) report in Beijing area and improve the ME monitor and report system.MethodsME cases which were reported by pharmacy departments of 22 hospitals in Beijing in 2012 were collected and analyzed. Analysis projects included category, classification, and triggering factor of ME and the number and proportion of persons who triggered or detected ME. Category A is potential error. Category B, C, and D are mild ME which did not harm patients. Category E, F, G, H, and I are severe ME which cause harm to patients even death.ResultsOne thousand one hundred and sixty-five cases of ME were totally reported by 22 hospitals in Beijing. Proportion of ME of category A, B, C, D, E, and F were respectively 5.9% (69 cases), 71.9% (837 cases), 19.3% (225 cases), 2.2% (26 cases), 0.5% (6 cases), and 02% (2 cases). ME of category G, H, and I have not been reported. In 1165 reports of ME, 1220 errors of classification were noted. Therein, the error of kinds of medications was the highest proportion which reached 27.2% (332 errors). The errors of administration route, dosage, and time respectively accounted for 12.0% (147 errors), 14.3% (175 errors), and 7.1% (86 errors). The content of unreasonable drug use was contained in the errors of kinds of medications, administration route and time. In 1165 reports of ME, 1183 triggering factors were noted. The top three factors were sound alike, prescribing errors, and look alike, whose proportions were 19.1% (226 errors), 14.0% (166 errors), and 8.3% (98 errors), respectively. In terms of the persons that triggered ME, the proportions of doctors, pharmacists, nurses, and patients or families were respectively 66.0%, 30.6%, 1.1%, and 2.3%. In terms of the persons who detected ME, doctors, pharmacists, nurses, and patients or family members respectively accounted for 14%, 88.8%, 4.6%, and 5.2%.ConclusionsThe report system of ME in Beijing had tended to be mature gradually. The operation model could be used for reference for national systems of ME monitor and report.

  • 专题讲座
    . 2002, 4(3): 178-185.
  • 安全用药
    . 2005, 7(5): 345-348.
    长期、大面积外用糖皮质激素进行皮肤病治疗有可能产生诸多不良反应,近来出现了一类可以局部外用的免疫调节剂,由于其疗效好,安全性高,长期使用也不会有外用糖皮质激素所产生的副作用,是一类在皮肤科领域具有广阔应用前景的药物。
  • 调查研究
    Liang Yan;Lu Yunlan
    . 2003, 5(2): 77-80.
    Objective;To investigate the adverse reactions of levofloxacin injection, including the frequency, manifestationsand the related factors. Method; A multicentre prospective study of levofloxacin injection was carried out in eight hospitals in Beijing between October 2000 and September 2001, and the collected data were analysed. Results- The adverse drug reactions occurred in 143 of 4437 inpatients (3.22%) , with 58.04% of mild type. The clinical manifestations most often involved the gastro-intestinal tract and skin. Conclusion: The adverse effects of levofloxacin injection showed generally low frequency and mild symptoms, which were associated with the dose, duration,interactions of levofloxacin administration. It should be used with care in elderly patients and in allergic subjects.
  • Zhao Wenli, Jiang Lili, Luo Simin, Li Weiling, Li Lehua
    Adverse Drug Reactions Journal. 2020, 22(9): 539-540. https://doi.org/10.3760/cma.j.cn114015‑20190910‑00752-
    A 22-year-old male patient received magnesium valproate sustained release tablets with increased dosage of 1-000-mg/d and quetiapine fumarate 600-mg/d due to recurrence of bipolar disorder, on the basis of previous treatment with magnesium valproate sustained release tablets 500-750-mg/d and quetiapine fumarate 400-600-mg/d. Seventeen days later, the patient developed abdominal pain suddenly. Laboratory tests showed blood amylase 4-710-U/L, lipase 649-U/L, and urine amylase 9-116-U/L. Abdominal CT examination showed blurred images around the pancreas. Acute pancreatitis induced by magnesium valproate sustained release tablets was considered. The drug was discontinued and quetiapine fumarate was continued. At the same time, symptomatic and supportive treatments such as fasting, omeprazole, somatostatin, and ceftazidime were given. Three days later, the patient′s abdominal pain basically disappeared; 10 days later, his blood amylase was 101-U/L and lipase was 118-U/L.
  • Guo Xiaohong, Mei Dan, Xu Yanyan, Gu Haijuan, Deng Jinling
    Adverse Drug Reactions Journal. 2020, 22(7): 418-419. https://doi.org/10.3760/cma.j.cn114015-20190314-00259
     A 74-year-old male patient was treated with pemetrexed on the basis of erlotinib for lung adenocarcinoma. For the first time, pemetrexed 800-mg dissolved in 0.9% sodium chloride 100-ml was given by intravenous injection. On the 3rd day after the treatment, the patient developed generalized skin rash, and then ulceration of oral mucosa and skin ulceration of perianal and scrotal area gradually appeared. The patient was diagnosed with exfoliative dermatitis. On the 6th day after the treatment, the patient developed diarrhea, which was gradually aggravated with the increased frequency from 3 to 4 times to 10 to 12 times daily. On the 9th day, after the treatment the patient developed myelosuppression (grade IV), with white blood cell count (WBC) 0.6×109/L, neutrophils count 0.1×109/L, red blood cell count (RBC) 2.04×1012/L, hemoglobin (Hb) 65-g/L, and platelet count (PLT) 77×109/L. Despite the active treatments with anti-allergy, antidiarrheal, and blood cell regeneration stimulating drugs, the patient′s myelosuppression was aggravated. On the 15th day after the treatment, laboratory tests showed WBC 0.1×109/L, neutrophil count 0, RBC 2.53×1012/L, Hb 80-g/L, and PLT 1×109/L. The patient′s treatment was given up at the request of his family members and the patient died on the 18th day after the treatment.
  • Wang Qin1, Yang Fangfang1, Bu Yanggao1, Zhang Chenchen2
    Adverse Drug Reactions Journal. 2020, 22(2): 111-112. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.012
    A 37-year-old female patient received an IV infusion of iron sucrose injection 200 mg dissolved in 250 ml of 0.9% sodium chloride injection for ectopic pregnancy and mild anemia. About 3 minutes of infusion, the patient suddenly developed laryngeal discomfort and irritating cough. Her symptoms worsened rapidly, dyspnea and cyanosis appeared, oxygen saturation decreased to 0.87, blood pressure was 87/56 mmHg, and heart rate was 121 beats/min. Laryngeal edema induced by iron sucrose injection was considered. Iron sucrose was discontinued immediately, oxygen inhalation and a total dose of dexamethasone 20 mg by IV infusion or IV injection were given. The patient′s symptoms gradually improved. Two hours later, her vital signs were stable and the symptoms disappeared.
  • 安全用药
    . 2006, 8(2): 113-116.
    辛伐他汀为临床较常用的降血脂药,为了解其不良反应,向临床安全用药提供参考,我们搜集国内外有关辛伐他汀不良反应的文献,进行归纳分析。辛伐他汀的主要不良反应有横纹肌溶解、记忆丧失、狼疮样综合征、急性胰腺炎、血小板减少性紫癜、勃起功能障碍、肝损害、多尿等,临床应用时应予以重视。
  • 安全用药
    . 2002, 4(4): 233-235.
    本文综合有关药物引起低钠血症的报告资料,通过资料分析发现能引起低钠血症的药物为数不少,尤以脑垂体后叶素及其类似物、5-羟色胺再摄取抑制剂(SSRIs)、卡马西平等报道最多。对于轻、中度的低钠血症早发现、早治疗预后良好,严重的低钠血症如抢救不及时则可能导致脑水肿、昏迷、不可逆脑损害、甚至死亡。使用这些药物时应注意掌握剂量,并嘱患者限制液体的摄入。低钠血症的治疗以输入高渗盐水为主,伴随的其它临床症状可对症治疗。
  • 安全合理用药
    . 2007, 9(2): 105-107.
    为加强奥卡西平临床应用的安全性,本文从该药的药代动力学和药效学两方面,进一步论述其产生不良反应和与其他药物相互作用的机制,供临床选用该药时参考。
  • 药物评介
    . 2004, 6(6): 398-400.
  • Zhang Qingxia, Li Siyan, Bai Xiangrong, Wang Zimin, Yan Suying, Wang Yuqin, Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, Chinese Pharmacological Society Professional Committee of Drug?induced Diseases, Adverse Drug Reactions Journal Agency
    Adverse Drug Reactions Journal. 2024, 26(7): 390-398. https://doi.org/10.3760/cma.j.cn114015⁃20240617⁃00454
    In 2023, a total of 27 742 cases of medication error (ME) from 439 hospitals in 27 pro‑vincial administrative regions were collected in the National Monitoring Network for Clinical Safe Medica‑tion. Among them, 282 (1.02%) were classified as grade A, 22 452 (80.93%) as grade B, 4 239 (15.28%) asgrade C, 499 (1.80%) as grade D, 141 (0.51%) as grade E, 127 (0.46%) as grade F, 1 (<0.01%) as grade G,and 1 (<0.01%) as grade I; no MEs of grade H occurred. Among the 27 460 patients involved in MEs ofgrade B to I, 15 131 (55.10%) were male and 12 329 (44.23%) were female; their ages were from 1 day to103 years; 3 198 (11.65%) were children (<18 years old), 12 576 (45.80%) were young and middle‑agedadults (≥18 to <60 years old), and 11 686 (42.56%) were elderly (≥60 years old). The top 3 contents of MEwere wrong drug class (5 880 cases, 20.97%), wrong dosage (4 668 cases, 16.65%), and wrong administration·390·药物不良反应杂志 2024 年7月第 26 卷第7期 ADRJ,July 2024, Vol. 26, No. 7frequency (3 184 cases, 11.35%). A total of 270 patients were involved in severe MEs (grade E‑I), including140 (51.85%) males and 130 (48.15%) females, aged from 52 days to 94 years, of which 31 (11.48%) werechildren, 91 (33.70%) were young and middle‑aged adults, and 148 (54.82%) were elderly. The top 3 drugsinvolved were cefoperazone sodium and sulbactam sodium, metformin, and estazolam. One fatal ME wascaused by mistakenly orally taking Fufang Jingjie for fumigation and washing. Among the 27 460 gradeB‑I MEs, 19 655 (71.58%) were triggered by physicians, 5 688 (20.71%) by pharmacists, and few by nurses,patients and their family members, etc. These MEs mainly occurred in clinics (10 537 cases, 38.37%), inhospital wards (8 187 cases, 29.81%), and in pharmacies (6 470 cases, 23.56%). But among the 270 severeMEs, 121 (44.81%) occurred in the patient′s home. The top 3 persons who discovered the ME were phar‑macists (20 693 cases, 74.46%), patients and their family members (3 240 cases, 11.66%), and physicians(2 214 cases, 7.97%). The top 3 factors causing ME were lack of related pharmacologic knowledge (9 382cases, 28.3%), tiredness (5 974 cases, 18.05%), and insufficient training of medical workers (3 831 cases,11.58%). In view of MEs with high incidence or more severe in 2023, relevant risks should be paid attentionto, including misusing external drugs for internal use, ingestion of drug packaging by mistake, wrong doseconversion in children, ME in special dosing frequency, too fast infusion speed of enteral nutrition prepara‑tions and irritant intravenous preparations, interaction between montmorillonite powder and other drugs,hypernatremia caused by fosfomycin sodium, etc. In addition, strengthening the management of drug varietieswith frequent severe MEs and fatal MEs, as well as the popular science and safe drug use education forpatients, can help ensure the medication safety of patients.
  • 安全用药
    . 2004, 6(5): 312-315.
    本文对长效干扰素治疗慢性丙型肝炎中出现少见和严重的不良反应进行综合报道,包括少见的皮肤损害、严重的肺部损害和精神神经系统不良反应等,旨在提醒临床医生使用长效干扰素时应注意类似不良反应的发生,保证患者用药安全。
  • 综述
    Cai Haodong;Sun Fengxia
    . 2007, 9(4): 229-234.
    Pyrrolizidine alkaloids (Pas) in the plants is one of the main causes of hepatic veno-occlusive disease occurring.Cases of hepatic veno-occlusive disease or liver damage associated with Pas-containing plants or medicinal herbs have been reported in America, England, China, and many other countries. There are more than six thousands kinds of the plants that contain Pas in the whole world. The Pas are primarily found in members of four plant families, I.e. (1) Compositae family: mainly in the genera Senecio, Ligularia, Eupatorium, Gynura, and Petasites; (2) Boraginaceae family: all plants of this family; (3) Leguminosae family: mainly in the genus Crotalaria; (4) Orchidaceae family: in the genus Liparis. There are thirty-eight kinds of Pas-containing medicinal herbs in China, and twelve of them are common in clinical practice as follows: Senecio scanden, Senecio campestri, Gynura segetum, Tussilago farfara, Herba Eupatorii, Herba lycopi, Radix Asters, Lithospermum, Heliotropium, Crotalaria sessiliflora, Crotalaria pallide, Liparis. The Pas have minimal toxicity in their original form, but their metabolites have hepatoxicity. In most instances of Pas liver toxicity in adults, the daily intake was several milligrams or hundreds of milligrams. However, it has been suggested by the WHO that the lowest intake of Pas that cause veno-occlusive disease in a human is just 0.015 mg/(kg·d). For a 70 kg adult, that would correspond to 1 mg total per day. The clinical manifestations of hepatic veno-occlusive disease are mainly refractory ascites, jaundice, hepatomegalia. There are no specific therapy for hepatic veno-occlusive disease, except symptomatic therapy and supportive therapy. Recently, the glucocorticosteroid or heparin therapy for Pas intoxication is reported, but their effect and safety are still under research. The authors consider that the education and monitoring for Pas-containing plants intoxication should be strengthened in our country.
  • 安全用药
    . 2001, 3(1): 30-32.
  • Sun Zuoyan, Wang Daoyan, Chen Zhongguang
    Adverse Drug Reactions Journal. 2024, 26(11): 677-682. https://doi.org/10.3760/cma.j.cn114015-20240110-00021
    Objective To explore the occurrence and risk factors of piperacillin sodium and tazobactam sodium (TZP)-related hypokalemia. Methods The clinical data of adult inpatients treated with TZP in Linyi Central Hospital from January 2022 to January 2023 were collected through the hospital′s electronic medical record system, including patient demographic information, infection sites, major underlying diseases, laboratory tests, TZP use information and concomitant drugs, and patients with TZP-related hypokalemia were screened. The occurrence of TZP-related hypokalemia was analyzed by descriptive statistics. According to whether or not having TZP-related hypokalemia, the patients were divided into hypokalemia group and non-hypokalemia group, and the clinical characteristics were compared. The clinical characteristics with statistically significant differences between 2 groups were included in the multivariate logistic regression, and the risk factors of TZP-related hypokalemia were analyzed. Results A total of 363 patients were included in the analysis, of which 86 (23.7%) were with hypokalemia and were judged to be associated with TZP, 46 (53.5%) were male and 40 (46.5%) were female; the age was 76 (68, 83) years. Of the 86 patients, 76 (88.4%) had mild hypokalemia, 10 (11.6%) had moderate hypokalemia, and none had severe hypokalemia. Through clinical characteristic comparison between the hypokalemia group and the non-hypokalemia group, statistically significant differences were found in patient gender, age, body mass index, the proportion of patients with pulmonary infection, abdominal/gastrointestinal infection, and urinary tract infection, the proportion of patients with coronary atherosclerotic heart disease and without major underlying diseases, baseline hemoglobin, serum total protein, serum albumin, blood calcium, blood magnesium, and the proportion of patients using potassium preserving diuretics and other diuretics during TZP treatment (all P<0.05). The above variables were included in the multivariate logistic regression, and the results showed that only the baseline level of blood magnesium was an independent influencing factor of TZP-related hypokalemia, and the lower the level, the higher the risk (odds ratio=0.105,95% confidence interval: 0.012-0.956,P=0.045). Conclusions Hypokalemia is a common adverse reaction of TZP, which should be paid attention to in clinic. The lower level of blood magnesium at baseline may be related to the increased risk of hypokalemia during TZP treatment.
  • Yin Huanli, Yu Lei, Su Lan, Wu Fengbo
    Adverse Drug Reactions Journal. 2023, 25(12): 763-765. https://doi.org/10.3760/cma.j.cn114015-20230118-00028
    A 25-year-old woman received subcutaneous injection of semaglutide injection (semaglutide) 0.5-mg by herself for weight loss. She developed nausea and vomiting after medication but did not pay much attention to. On the 2nd week, semaglutide 1-mg was injected subcutaneously. Symptoms such as nausea and vomiting were aggravated, followed by stomach pain and distension, which could not be relieved. Laboratory tests showed alanine aminotransferase (ALT) 1-687-U/L, aspartate aminotransferase (AST) 809-U/L, alkaline phosphatase (ALP) 167-U/L, total bile acid (TBA) 178.8-μmol/L, total bilirubin (TBil) 106.3-μmol/L, direct bilirubin 64.0-μmol/L, and indirect bilirubin (IBil) 42.3-μmol/L. After excluding causes like viral hepatitis, autoimmune liver disease, obstructive jaundice, and concomitant drugs, acute liver injury caused by semaglutide was considered, and liver-protective treatments were given. Due to poor therapeutic effects, artificial liver treatment was given once, and then liver protective treatments were continued. On day 17 of treatment, laboratory tests showed ALT 579-U/L, AST 583-U/L, ALP 180-U/L, TBA 231.8-μmol/L, TBil 344.8-μmol/L, DBil 233.8-μmol/L, and IBil 111.0-μmol/L. After 6 months of treatments, the patient′s liver function returned to normal, with laboratory tests results of ALT 56-U/L, AST 33-U/L, ALP 99-U/L, TBA 2.7-μmol/L, TBil 10.5-μmol/L, DBil 3.2-μmol/L, and IBil 7.3-μmol/L.
  • 综述
    . 2006, 8(2): 81-87.
    新型抗癫痫药与传统抗癫痫药相比,具有较理想的药代动力学特性,不良反应和药物相互作用较少,耐受性和安全性较好。由于新型抗癫痫药上市时间较短,临床资料和用药经验相对较少,其安全性问题尤其值得人们关注。本文对9种新型抗癫痫药从作用机制、药代动力学、不良反应、相互作用等方面作一综合评价。
  • 安全用药
    DENG Hua;LEI Zhao-bao
    . 2012, 14(2): 88-5.
    Statins are hydroxymethyl glutarate coenzyme A reductase inhibitors, which have been used widely in clinical practice as lipid-lowering drugs currently. The clinical features of statin-induced liver injury (SILI) are not special and similar to that of other drug-induced liver injury. The hepatocellular type of SILI is more common, the cholestatic type is less common, and mixed type is rare. The mechanisms of SILI may be associated with toxicity of statins, secondary pharmacological effects of statins, immune mechanisms, and so on. The risk factors for SILI are high-dose, drug combination, a history of liver disease, etc. If the liver damage is mild, the drug dosage should be reduced and the drug is continued; if the liver damage is moderate, the drug dosage of statins should be reduced and hepatoprotective treatment should be given at the same time; if the liver damage is severe, statins should be stopped at once and symptomatic treatments should be given. During treatment with statins, clinicians should control strictly the dosage of statins, enhance laboratory monitoring, avoid drug combination, and tell the patients to improve nutritional status and pay attention to rest. Statins should be used with caution in patients with liver diseases. The SILI is reversible in most patients.
  • Zhang Yatong, Liu Junpeng, Zhao Zinan, Lu Hongliu, Hu Xin
    Adverse Drug Reactions Journal. 2020, 22(8): 450-454. https://doi.org/10.3760/cma.j.cn114015-20200309-00241
    Objective To explore the effect of amiodarone combined with rivaroxaban on the plasma concentration of rivaroxaban in patients with non-valvular atrial fibrillation. Methods This study was designed as the prospective cohort study. The subjects were selected from patients with atrial fibrillation who were hospitalized in the Department of Cardiology of Beijing Hospital from January to October 2019 and treated with rivaroxaban (≥3 days). The enrolled patients were divided into the with amio- darone combination group and the without amiodarone combination group. The trough concentration and peak concentration of rivaroxaban were detected by chromogenic substrate method with anti-Xa assay kit. Taking the plasma concentration of patients with a daily dose of 20-mg of rivaroxaban as the standard,plasma concentrations in patients with various daily doses of rivaroxaban were standardized. The measured plasma concentrations,standardized plasma concentrations,and plasma concentrations in patients at daily dose of 20-mg of rivaroxaban were respectively compared between the 2 groups. Results A total of 65 patients were entered in the study, including 12 patients in the with amiodarone combination group (the daily dose of rivaroxaban was 20-mg) and 53 patients in the without amiodarone combination group (the daily doses of rivaroxaban were 20, 15, and 10-mg in 42, 9, and 2 patients, respectively). The differences in gender, age, weight, body mass index, smoking history, CHA2DS2-VASc score, HAS-BLED score, daily dose of rivaroxaban, liver and kidney function, and platelet count of patients between the 2 groups were not statistically significant (P>0.05 for all). The trough and peak plasma concentrations of rivaroxaban in the with amiodarone combination group were higher than those in the without combination amiodarone group, but the differences were not statistically significant [(43±30) ng/ml vs. (38±26) ng/ml, t=0.569, P=0.571; (294±114) ng/ml vs. (251±87) ng/ml, t=1.473, P=0.146]. The differences in standardized trough and peak plasma concentrations of rivaroxaban [(41±28) ng/ml, (273±108) ng/ml] in patients between the 2 groups, and the trough and peak plasma concentration [(40±27) ng/ml,(249±75) ng/ml] of patients at daily dose of 20-mg of rivaroxaban were not statistically significant (P>0.05 for all). Conclusion Amiodarone has no significant effects on the plasma concentration of rivaroxaban in patients with atrial fibrillation, however, it is still necessary to strengthen the patient monitoring in those with combination use of the 2 drugs.
  • Huo Jiping, Li Xingang, Zhao Zhigang
    . 2015, 17(6): 444-448.
    Drug-induced liver injury (DILI) is a serious public health problem which can not be ignored. The mechanism of DILI include drug factors, immune mechanisms and individual factors. The traditional biological markers, such as alanine aminotransferase, aspartate transaminase, alkaline phosphatase, γ-glutamine transferase, total bilirubin, and total bile acid, lack sufficient sensitivity and specificity, so they often can not predict liver injury in the early course of the disease. MicroRNA-122, α- glutathione-S-transferase, 5′-nucleotidase, paraoxonase, purine nucleoside phosphorylase, malate dehydrogenase, and other new biological markers have higher sensitivity and specificity. Among them, microRNA-122 is expected to become a reliable new biological marker to predict hepatotoxicity because its specific, stable and sensitive expression in the liver tissue. Glutamate dehydrogenase, α-glutathione-S-transferase, arginase Ⅰand serum protein F are expected to become biological markers for hepatocellular injury. The 5′-nucleotidase has higher sensitivity and specificity than alkaline phosphatase and γ-glutamine transferase, and it is expected to become a biological marker for cholestasis. At present, these new biological markers of liver injury are still in the research stage and it will take time to get into the clinical use.
  • 综述
    . 1999, 1(2): 88-91.
    本文通过对中药不良反应病例的分析,从中药的毒性、炮制、配伍、制剂、用法、用量,以及中药市场等七个方面对中药的安全性进行了探讨。由于诸多因素可以影响中药的安全性,因此必须对其加强研究,提高合理用药水平,保障用药安全。
  • Zhang Chenyu, Guo Lin, Li Yilei, Zheng Ping, Liu Shiting
    Adverse Drug Reactions Journal. 2022, 24(2): 108-110. https://doi.org/10.3760/cma.j.cn114015-20210514-00563
    A 57-year-old male patient with type 2 diabetes mellitus and hypertension was changed to metformin 0.5-g orally thrice daily, acarbose 0.1 g orally thrice daily, and subcutaneous injection of lixisenatide 20-μg once daily due to poor control of blood glucose with sitagliptin, glimepiride, and metformin. The drugs used at the same time included mecobalamin injection, alprostadil injection, irbesartan, and bisoprolol. The blood pressure before treatment was 116/71-mmHg. Two hours after the first injection of lixisenatide, the patient′s blood pressure rose to 179/98-mmHg, accompanied by facial flushing and mild nausea. The blood pressure decreased to 125/74-mmHg after oral administration of 10-mg nitrendipine. Next day, the patient received subcutaneous injection of lixisenatide 10-μg, facial flushing recurred and blood pressure rose to 160/90-mmHg, which returned to normal after treatment with oral 10-mg nitrendipine. Thereafter, lixisenatide was discontinued and blood pressure elevation did not recur.
  • 药害史
    . 2006, 8(3): 217-220.
    众所周知,在药物发展史上曾发生过多起重大药害事件,如磺胺酏剂(含二甘醇)事件、反应停事件等,造成成百上千患者死亡。回顾这些惨痛的药害事件,从中吸取教训,无疑有助于避免或减少这类事件的发生或重演,保障患者安全。为此,本刊特开辟“药害史”栏目,欢迎广大读者、作者向本栏目踊跃投稿。
  • Bai Shuang, Liu Mingyue, Geng Zhihui
    Adverse Drug Reactions Journal. 2020, 22(2): 103-104. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.008
     A 4-year-old boy received an IV infusion of cefoperazone sodium sulbactam sodium 0.8 g once per 12 hours for severe pneumonia. On day 3 of the treatment, the child developed brown urine, abdominal pain, pale skin, and cold limbs at about 15 minutes of the infusion. Then the infusion was stopped immediately. Laboratory tests showed decreased red blood cell count 1.7×1012/L(4.7×1012 before treatment)and hemoglobin 67 g/L(121 g/L before treatment), reticulocyte 0.12, total bilirubin 54.7 μmol/L, indirect bilirubin 42.4 μmol/L, direct Coombs test positive, urine protein (++), urine occult blood (++), urobilinogen (+++), 87 urine red blood cells per high power field. The acute hemolysis caused by cefoperazone sodium sulbactam sodium was considered. The drug was discontinued immediately and IV infusion of methylprednisolone and other symptomatic treatments were given. Then the boy′s condition gradually improved. The anti infection treatment was replaced by azithromycin for injection. On day 9 of cefoperazone sodium sulbactam sodium withdrawal, the boy′s blood routine and urine routine returned to normal and the direct Coombs test was negative.
  • 调查研究
    Wang Rui;Li Naxin;Dong Jingyuan
    . 2001, 3(4): 226-229.
    Objective: To investigate the general pattern and characteristics of ADRs to cephalosporins and to guide rational drug use.Methods: 386 cases developing drug adverse reactions to cephalosporins ,reported in Chinese literature in the past 10 years, were analysed.Results:There were 45 cases of type A reaction and 341 cases of type B reaction, mostly with allergic reactions (35.49%)and urinary lesion (29.02%). Serious ADRs amounted to 93 cases, of which,7died. Among cephalosporins, ADRs of cefoperazone (97cases), cefradine (78 cases) and cefazolin (69 cases) accounted for 25.13% , 20.21 % and 17.88% , respectively.Conclusion:Rational use of cephalosporins should be strengthened in the clinical practice in order to prevent and reduce the occurence of ADRs.
  • 综述
    . 2005, 7(5): 321-325.
    妊娠结核是严重危害母婴健康的妊娠并发症之一,如果处理不当可能引起母婴的严重不良后果。了解妊娠结核的发病率、妊娠与结核病的相互影响等的最新动态,掌握妊娠结核的临床表现、诊断、药物治疗以及不良反应处理等方面的新知识,将有利于保护妊娠结核的母婴健康。
  • Shen Yabing, Su Hongxia
    Adverse Drug Reactions Journal. 2020, 22(11): 648-649. https://doi.org/10.3760/cma.j.cn114015-20200112-00035
    A 28-month-old boy with Kawasaki disease received IV infusions of human immunoglobulin 15 g and sodium fructose diphosphate for injection 2.2 g once daily, and oral aspirin enteric-coated tablets 200-mg thrice daily. Two days after the treatments, the human immunoglobulin was stopped. Three days after the treatments, the dose of aspirin enteric-coated tablets was reduced to 75-mg once daily. The boy′s liver function was normal before the treatments. On the 5th day of treatments, laboratory tests showed that alanine aminotransferase (ALT) was 897-U/L, aspartate aminotransferase (AST) was 905-U/L, and lactate dehydrogenase (LDH) was 1-525-U/L. Drug-induced liver injury caused by aspirin enteric-coated tablets was considered. Aspirin was stopped and replaced by clopidogrel hydrogen sulfate, and glutathione and heparolysate were given for liver protection. Laboratory tests showed ALT 323-U/L, AST 66-U/L, and LDH 297-U/L 14 days later and ALT 27-U/L and AST 45-U/L 20 days later.
  • Wang Yina, Zuo Li, Yan Yu
    Adverse Drug Reactions Journal. 2024, 26(6): 321-325. https://doi.org/10.3760/cma.j.cn114015-20240407-00234
    Anticancer drugs play an important role in the treatment for malignant tumors. The kidney function of patients has an important impact on the choice of anticancer drugs, the safety during treatments, and the prognosis of patients. All cancer patients should undergo comprehensive kidney function assessment before using anticancer drugs, so as to formulate an individualized anticancer regimen. The Japanese Society of Nephrology, Japan Society of Clinical Oncology, Japanese Society of Medical Oncology, and Japanese Society of Nephrology and Pharmacotherapy have formulated the Clinical Practice Guidelines for Management of Kidney Injury During Anticancer Drug Therapy 2022 and made special discussions and suggestions on the evaluation of kidney function of tumor patients before anticancer drug treatment. This article interprets this part in order to made a more comprehensive understanding on the occurrence and risk factors of kidney disease in cancer patients in the clinic. Paying attention to the kidney function assessment of cancer patients before anticancer drug treatment and mastering the correct assessment methods can help improve the kidney safety of cancer patients during treatments.
  • . 2016, 18(1): 2.
  • . 2017, 19(1): 10-16.
    目的尝试建立中国儿童高警示药品目录,为儿童用药安全提供参考。方法以美国、荷兰和西班牙儿童高警示药品目录为基础,参考国内外儿童严重ADR文献报道,北京市、广东省、安徽省、湖南省和全军ADR监测中心儿童严重不良反应报告,INRUD临床安全用药监测网用药错误数据库中儿童用药错误报告,以及“医院处方分析合作项目”收集到的处方资料,建立中国儿童高警示药品初始目录。采用德尔菲法对初始目录进行专家论证。第1轮咨询聘请专家32名,根据专家意见对初始目录进行调整,形成修订版目录;第2轮咨询聘请专家同第1轮,根据专家意见对修订版目录进行调整,形成最终版目录。结果共遴选出17大类55种/类药物纳入中国儿童高警示药品目录,每种药物附有1~4个风险点和1~4条建议。32位专家对被评价药物熟悉程度的平均赋值均>0.60,判断依据的平均赋值均>0.70,权威程度的平均赋值均>0.70。第1轮调查表指标数为63个,专家协调系数为0.18。第2轮调查表指标数为59个,专家协调系数为0.24,2轮咨询专家意见协调系数差异均有统计学意义(χ2=516.424,P<0.05;χ2=721.635,P<0.05)。结论初步建立了中国儿童高警示药品目录,可作为促进儿童合理用药、降低儿童用药风险的工具。
  • Liu Jiajia, He Guilin, Wang Yuanyuan, Mao Min
    Adverse Drug Reactions Journal. 2023, 25(1): 59-61. https://doi.org/10.3760/cma.j.cn114015-20220421-00344
    A 68-year-old female patient with breast cancer and lung metastasis received fulvestrant injection (fulvestrant) 0.5 g intramuscularly on day 1, and palbociclib capsules (palbociclib) 75-mg once daily orally for 21 days with a 7-day interval; 28 days was a cycle. Before treatments, laboratory test showed brain natriuretic peptide 811.3-ng/L and the electrocardiogram showed no obvious abnormality. During the 7th treatment cycle, the patient developed dyspnea after climbing stairs, accompanied by chest pain, chest tightness, and palpitations. N-terminal pro-brain natriuretic peptido (NT-proBNP) was 4-001-ng/L. Echocardiography showed that the left ventricular ejection fraction (LVEF) was 25%, the left ventricular wall motion was generally weakened, the left ventricle was enlarged, and the left ventricular systolic and diastolic functions were reduced. Electrocardiogram showed sinus tachycardia and ST-T changes. Heart failure with reduced ejection fraction caused by fluvestrant and palbociclib was considered. The 2 drugs were discontinued and anti-heart failure therapy including sacubitril valsartan, torasemide, and metoprolol succinate was given for 40 days. The patient′s dyspnea and chest tightness were improved. Laboratory test showed NT-proBNP 4-345-ng/L, echocardiography showed LVEF 26%, and coronary angiography showed no stenosis. Coronary artery disease was excluded, and chronic heart failure was diagnosed, with cardiac function of grade Ⅲ. After implanting the implantable cardioverter defibrillator and continuing the anti-heart failure drug treatment for 24 days, NT-proBNP decreased to 2-321-ng/L, LVEF was 25%, and cardiac function was grade Ⅰ-Ⅱ.
  • Liu Chen, Zhao Hao, Wang Ning, Li Jingjie, Chu Yanqi, Yan Suying
    Adverse Drug Reactions Journal. 2022, 24(8): 404-409. https://doi.org/10.3760/cma.j.cn114015-20220310-00200
    Objective To evaluate the efficacy and safety of sodium valproate in the prevention of epileptic seizure during the perioperative period in neurosurgical patients. Methods The medical records in patients, who were treated with sodium valproate during perioperative period in Neurosurgery Department of Xuanwu Hospital, Capital Medical University from March to June 2021, were collected and data including the basic information in patients, use of sodium valproate and the combination drugs, valproic acid blood concentration (reference range: 50-100-mg/L), and adverse reactions was recorded. The effects of the first intravenous dose of valproate and the combination drugs on the blood concentration of valproic acid and the efficacy and safety of sodium valproate in preventing epileptic seizure were analyzed. Results A total of 107 patients were enrolled, including 48 males and 59 females, aged (54±13) years. The median total dose of sodium valproate administered intravenously was 5-600-mg (range: 800-17-600-mg), the median duration of intravenous therapy was 3 days (range: 1-10 days), and the blood concentration of valproic acid was (53.5±19.6) mg/L. The median hospital stay was 16 days (range: 6-49 days) and no patients had seizures during hospitalization. The first intravenous dose of sodium valproate was insufficient in 38.3% (41/107) of the patients and the valproic acid blood concentration and its compliance rate to the reference range in these patients were significantly lower than those in the patients with appropriate first intravenous dose [(43±21)mg/L vs. (60±16)mg/L, P<0.001; 22.0%(9/41) vs. 78.5% (51/65), P<0.001]. Carbapenems was used for 1 day in combination with sodium valproate in 6 patients, 3 of whom had the blood concentration that was lower than the reference range. However the difference in the blood concentration of valproic acid between patients with and without carbapenems use was not statistically significant[(43±26) mg/L vs. (54±19) mg/L, P=0.187]. In the 107 patients, a total of 60 adverse events occurred in 49 patients (45.8%), including hyperammonemia in 33 patients (30.8%) , elevated activated partial thromboplastin time in 12 patients (11.7%), hypofibrino- genemia in 3 patients (2.9%), hyponatremia in 6 patients (5.6%), liver injury in 4 patients (3.7%), and kidney injury and thrombocytopenia in 1 patient (0.9%) each. The severity of adverse reactions was grade 1, 3, and 4 in 39, 9, and 1 patient, respectively. The incidence of serious adverse reactions of grade 3 and above was 9.3% (10/107). Of the 10 patients with serious adverse events, 7 had hyperammonemic encephalopathy, 2 had liver injury, and 1 had hyperammonemic encephalopathy and liver injury. One patient who developed grade 3 adverse reaction died due to primary disease (brain tumor with stroke). Conclusions The use of sodium valproate during perioperative period in neurosurgery patients to prevent epileptic seizures is safe and effective in general, but adverse reactions such as elevated blood ammonia, liver injury, and coagulation dysfunction may occur. Insufficient first intravenous dose and concomitant use of carbapenems may affect the blood concentration of valproic acid, which should be paid attention to.
  • 学术研讨
    . 2005, 7(3): 161-164.
  • 药物评介
    Ding Qingming①;Ren Liankun②
    . 2007, 9(4): 295-301.
    Levetiracetam,an analogue piracetam,is one of newer antiepileptic drugs used as adjunctive therapy(added to other antiepileptic drugs)of partial seizures,myoclonic seizures,and primary generalized tonic-clonic seizures.Levetiracetam is rapidly and almost completely absorbed after oral administration,and peak plasma concentration are usually achieved within 1.3 hours.The extent of bioavailability of levetiracetam is not affected by food.Levetiracetam is less than 10% bound to plasma proteins.Plasma half-life of levetiracetam is approximately 6~8 hours.The initial adult dose is 1 g in two divided doses on the first day of treatment,thereafter,the daily dose may be adjusted in increments of 1 g every 2 to 4 weeks until effective antiepileptic control is achieved,up to a maximum dose of 3 g daily.The most common adverse reactions to levetiracetam are somnolence,weakness,and dizziness.Levetiracetam should be used with caution and in reduced doses in patients with renal impairment and in patients with severe hepatic impairment.Withdrawal of levetiracetam therapy should be made gradually(reducing the daily dose by 1 g every 2 to 4 weeks),sudden withdrawal may induce an increase in the frequency of seizures.
  • Zhen Shujuan, Zhang Jianjiang, Zeng Huiqin, Wang Qin, Jia Mengmeng
    Adverse Drug Reactions Journal. 2022, 24(10): 515-521. https://doi.org/10.3760/cma.j.cn114015-20220407-00293
    Objective To explore the effect of drug metabolism gene polymorphisms on blood concentration and safety of tacrolimus (TAC) in children with refractory nephrotic syndrome (RNS). Methods The study was designed as prospective observational clinical study. The subjects were selected from the children with RNS who were hospitalized in Department of Pediatrics, the First Affiliated Hospital of Zhengzhou University from September 1, 2018 to August 31, 2019 and planned to receive TAC (first application) at the basis of glucocorticoids treatment. Clinical research files were formed and clinical conditions within 6 months of TAC treatment were recorded in detail for all subjects. The peripheral venous blood of all children was collected on the 7th day after TAC application for TAC blood trough concentration detection, and the TAC dose was adjusted according to the results. Blood samples were collected at the right time during hospitalization and gene polymorphisms of adenosine triphosphate binding cassette transporter B1 (ABCB1), cytochrome P450 (CYP) 2C19, CYP3A4, CYP3A5 and nuclear receptor subfamily 1, group I, member 2 (NR1I2) were detected. Children who completed 6 months of TAC treatment and follow-up were included. According to the genotype detection results, children were divided into wild-type group, heterozygous mutant group, and homozygous mutant group and first dose-adjusted blood trough concentration (C/D) of TAC were compared; they were divided into mutation carrier group (including heterozygous mutation carriers and homozygous mutation carriers) and wild-type group and the incidence of adverse reactions were compared. Results A total of 39 children were included in the analysis, including 24 males and 15 females, aged 3 to 13 years with a median age of 8 years. The comparison results of the first C/D of TAC among various genotype groups showed that the TAC C/D in children of CYP2C19-homozygous mutant (*2*2) group was higher than that of wild-type (*1*1) group [3.65 (2.78, 7.43) μg/L vs. 1.53 (1.27, 3.33) μg/L, P=0.032], TAC C/D in children of CYP3A5 homozygous mutant (*3*3) group was significantly higher than those of the wild-type (*1*1) group and heterozygous mutation (*1*3) group [3.68 (3.05, 5.14) μg/L vs. 2.10 (0.77, 3.56) μg/L and 1.74 (1.47, 3.25) μg/L, P=0.046, P=0.009], and no significant differences were found in TAC C/D among different genotypes in CYP3A4, ABCB1, or NR1I2 (all P>0.05). A total of 7 children had adverse reactions within 6 months of TAC treatment (Naranjo′s assessment scale, "probable" in 2 children and "possible" in 5 children), including infection, rash, hypertensive encephalopathy, and convulsions in 4, 1, 1, 1 child, respectively. The incidence of adverse reactions in ABCB1 mutation carrying children (CT and TT) was significantly higher than that in children of wild-type (CC) group [30.4% (7/23) vs. 0 (0/16), P=0.033]. Conclusion CYP2C19 and CYP3A5 gene polymorphisms have significant effects on TAC blood concentration, and ABCB1 gene polymorphisms have significant effects on the safety of TAC application, which should be noticed in clinic.
  • Wang Dongxue, Hou Jiqiu, Xu Feng
    Adverse Drug Reactions Journal. 2021, 23(9): 491-492. https://doi.org/10.3760/cma.j.cn114015-20201225-01284
     A 44-year-old male patient received moxifloxacin 0.4 g orally once daily for pulmonary infection. He had normal renal function with serum creatinine (Scr) 67-μmol/L before treatment. Three days after medication, the patient developed abdominal pain, vomiting, oliguria, and 5 days later, laboratory tests showed Scr 1-372-μmol/L, blood urea nitrogen (BUN) 30.5-mmol/L, and estimated glomerular filtration rate (eGFR) 3.3-ml/(min·1.73 m2). Acute tubulointerstitial nephritis was diagnosed by renal puncture and pathological examination. Drug-induced kidney injury was considered, which might be related to moxifloxacin. Moxifloxacin was discontinued and hemodialysis, anti-infection, and symptomatic treatments were given. The patient′s urine volume gradually recovered and renal function was improved. Fifteen days later, his Scr was 293-μmol/L and BUN was 10.5-mmol/L. One and a half months later, the Scr was 185-μmol/L and BUN was 9.8-mmol/L.
  • 论著
    Dai Zhijun①;Wang Xijing①;Kang Huafeng①;Guan Haitao①;Liu Xiaoxu①;Song Lingqin①;Cheng Chong①;Ji Zongzheng②
    . 2007, 9(1): 10-14.
    Objective: To observe the efficacy and adverse reactions of Shenqifuzheng injection used in patients with breast cancer while receiving neoadjuvant chemotherapy. Methods: Clinical deta of 126 patients with local advanced breast cancer while receiving neoadjuvant chemtherapy was collected from January, 2000 to December, 2005. The 126 patients were divided randomizely into two groups: control group (61 cases) and study group (65 cases). The patients in the control group were administered with CEF regimen (CTX 500 mg/m2, d1, 8; EPI 50 mg/m2, d1, 8; 5-Fu 500 mg/m2, d1, 8). The patients in the study group were treated with CEF regimen plus Shenqifuzheng injection (intravenous infusion of 250 ml, once daily). The cycle of chemotherapy was 28 d, and total two cycles were performed for the two groups. The efficacy, the changes of T lymphocyte and NK cells, and the adverse reactions to neoadjuvant chemotherapy in the two groups were observed before and after the treatment. Results: The overall …更多effective rate of the study group and control group were 69.2% (45/65) and 49.2% (30/61) respectively, and the difference was statistically significant between the two groups (P<0.05). The T lymphocyte subsets and NK cells in the study group were elevated in varying degree in comparison with those in the control group, and the differences were significant (P<0.05). The common adverse reactions of the two groups were myelosuppression and gastrointestinal reactions, but the severity of the reactions of the study group were relative mild than that of the control group. Conclusion: Shenqifuzheng injection can elevate immune function of patients with advanced breast cancer while receiving neoadjuvant chemotherapy. It can also enhance the efficacy and decrease the adverse reactions to neoadjuvant chemotherapy
  • Guo Hao, Qi Shibo, Zhou Tiantian, Yi Zhanmiao
    Adverse Drug Reactions Journal. 2020, 22(12): 677-682. https://doi.org/10.3760/cma.j.cn114015-20200403-00371
    Objective To explore the clinical characteristics of thrombocytopenia caused by levetiracetam (LEV). Methods The diagnosis and treatment of a patient with thrombocytopenia caused by LEV in Peking University Third Hospital were reported. The main clinical data (gender, age, indications of LEV medication, usage and dosage of LEV, comorbidities, combined medication, platelet count before and after medication, time from LEV medication to onset of thrombocytopenia, clinical management and outcome, etc.) of the case and relevant cases collected from PubMed, Embase, CNKI, and Wanfang database (as of February 1, 2020) were summarized and analyzed. Results A total of 14 patients were enrolled in the study, including 4 males and 10 females, aged from 4 months to 79 years with a median age of 57 years. There were 5 cases of primary epilepsy and 9 cases of secondary epilepsy, including 4 cases of stroke secondary epilepsy, 4 cases of brain tumor secondary epilepsy, and 1 case of viral encephalitis. Among them, 8 patients had low immune function; 4 patients were treated with LEV alone and 10 were treated with LEV combined with other antiepileptic drugs. The time from the application of LEV to onset of thrombocytopenia was 2- 150 days and the median time was 8.5 (3.2, 18.5) days after medication. The severity of thrombocytopenia was defined as grade 1, 2, 3, and 4 in 1, 4, 1, and 8 patients, respectively. After the onset of thrombocytopenia, LEV was discontinued in all the 14 patients. Of them, 9 cases were improved without special intervention, 4 cases were improved after symptomatic treatments (with human immunoglobulin, hormone, and platelet transfusion in 1 case, human immunoglobulin, hormone, and anti-CD20 monoclonal antibody in 1 case, and intravenous platelet transfusion in 2 cases), and a 4-month-old infant died of septic shock and multiple organ failure. Conclusion LEV-related thrombocytopenia may occur 2-150 days after the first medication and usually in patients with immunodeficiency, which could be improved by drug withdrawal alone or combination with symptomatic treatments as appropriate.
  • 调查研究
    Liang Yan;Zhang Haiyan;Lu Yunlan;Cui Yimin
    . 2005, 7(2): 95-97.
    Objective: To investigate the safety of influenza vaccine. Methods: After administration of influenza vaccine in 1325 individuals in 2003 the incidence type and outcome of adverse reactions (AR) were analysed. Results: The AR incidence was 55.32% (733 / 1325) including local reactions (77.76%570 / 733) with duration median of 3 days and systemic reactions (42.43%311 / 733) with duration median of 2 days. Moderate and mild AR were in a majority the latter in particular(57.57%). Persons with AR were all cured (431) or self-cured (302). Conclusion: Influenza vaccine is safer in consideration of AR nature of mildness short duration and easy recovery.
  • 调查研究
    Wang Yuqin①;Wen Manhua①;Chang Ming②;Ding Qinghua②;Zeng Yan①;Meng Li①;Wu Xiaoguang①;Tang Zhe①;Niu Guangsheng③
    . 2004, 6(2): 78-82.
    Objective : To investigate adverse reactions in SARS patients treated with glucocorticoids. Method:Clinical data of460cases with SARS in Xuanwu Hospital and China-Japa n Friendship Hospital were retrospectively analysed using SPSS statistical softw are.Results:344of460cases were under glucocorticoids therapy(GT),resu lting in decreased serum potassium(17.2%)and serum calcium(32.0%) ,increased blood sugar(30.5%),psychogeny(20.1%),bacterial infec tion(53.5%),mycotic infection(14.8%),and liver impairment (60 .2%).The incidence of adverse reactions were much higher in GT group of≥3 20mg daily than group of<320mg daily,and in GT group than in non-GT gr oup.Conclusion:Glucocorti-coids should only be used with great caution in SAR S patients,that is,paying more attention to existing indications and fol-lowi ng adverse effects,taking the drug doses as low as possible,and high doses may be only used for life-threatening case.
  • Qiu Yujie, Wang Yuqin, Zhang Qingxia
    Adverse Drug Reactions Journal. 2022, 24(9): 454-461. https://doi.org/10.3760/cma.j.cn114015-20220321-00228
    Objective To analyze the occurrence of medication errors (MEs) and their influen- cing factors on proton pump inhibitors (PPIs) and to provide reference for the standard use of PPIs in clinic. Methods The ME reports on PPI-related MEs in the National Monitoring Network for Clinical Safe Medication (monitoring network) from January 1, 2020 to December 31, 2020, were collected and information of MEs including drugs involved, ME grading, error content, the persons who triggered and found the errors, and the factors that caused the errors were analyzed. Results A total of 593 PPI-related ME reports from 97-hospitals in 21 provinces and municipalities in China were collected in the monitoring network in 2020. A total of 593 patients were involved, including 358 males (60.4%) and 235 females (39.6%), aged from 1 to 99 years old with an average age of 53.7 years. In the 593 MEs, there were 418 (70.5%), 167 (28.2%), 7 (1.2%), and 1 (0.2%) MEs were graded as grade B, C, D, and E, respectively; a total of 6 kinds of PPIs were involved and 649 times of ME occurred, of which 177 times (27.2%) were related to omeprazole, 143 (22.0%) to rabeprazole, 135 (20.8%) to esomeprazole, 123 (19.0%) to pantoprazole, 66 (10.2%) to lansoprazole, and 5 (0.8%) to ilaprazole. Among the 593 patients, the medication indications for PPIs included prevention of stress mucosal injury in 303 patients (51.1%), gastroesophageal reflux disease in 91 patients (15.3%), peptic ulcer in 64 patients (10.8%), upper gastrointestinal bleeding in 25 patients (4.2%), helicobacter pylori infection eradication in 6 patients (1.0%), and non-steroidal anti-inflammatory drug-related ulcers in 6 patients (1.0%). There were 103 patients (17.4%) received PPIs without appropriate indications and 5 patients (0.8%) with 2 indications at the same time. The 593 ME reports involved a total of 609 times of ME content, and the wrong indication (16.9%, 103/609) ranked the first, followed by the wrong drug class (16.3%, 99/609) and the wrong medication frequency (14.0%, 85/609). Among the 593 MEs, 75.1% (445 MEs) were triggered by physician, 20.7% (123 MEs) by pharmacists, 2.5% (15 MEs) by nurse, 0.7% (4 MEs) by patients/family members, and 1.0% (6 MEs) by others; 418 MEs (70.5%) were detected and intercepted in time, of which 87.6% (366/418) were found by pharmacists, 8.1% (34/418) by nurses, and 4.3% (18/418) by patients/family members. The factors that caused MEs occurred 659 times in total, mainly including lack of knowledge/insufficient training (accounting for 50.8%, 335/659), fatigue (accounting for 18.4%, 121/659), and look alike/sound alike (accounting for 9.1%, 60/659). Conclusions The contents of PPIs-related MEs mainly include wrong indications, wrong drug class, and wrong medication frequency. MEs are mainly caused by physicians and mostly discovered and intercepted by pharmacists. Lack of knowledge/inadequate training is a major factor in causing MEs.
  • Ran Shan, Zhang Ming, He Zhigao
    Adverse Drug Reactions Journal. 2021, 23(10): 555-557. https://doi.org/10.3760/cma.j.cn114015-20201230-01300
    A 78-year-old male patient with peritoneal dialysis received Juhong Tanke (橘红痰咳液) solution 10-ml thrice daily and 4 Jinqiaomai tablets (金荞麦片) thrice daily orally because of cough at night for 3 weeks(conventional abdominal dialysis maintenance treatment was given according to the original schedule). On day 5 of treatments, the peritoneal exudate was turbid. Laboratory tests showed white blood cell count (WBC) 1.1×109/L, neutrophils 0.65, hemoglobin (Hb) 105-g/L, platelet count (PLT) 90×109/L, high sensitivity C-reactive protein 26.9-mg/L, and procalcitonin 10.89-mg/L; the examination for exudate showed WBC 13-131×106/L and neutrophils 0.96. Acute diffuse peritonitis was diagnosed. Meropenem, moxifloxacin, norvancomycin, vancomycin, and linezolid were given successively along with the peritoneal dialysis, the infection was still not well controlled, and then the anti-infective drugs were changed to an IV infusion of tigecycline 50-mg twice daily. On day 9 of tigecycline treatment, the patient had sudden cold sweats and palpitations with fatigue, dizziness, and hunger. The peripheral blood glucose level was 2.0-mmol/L. An intravenous injection of 50% glucose was given and the blood glucose increased to 5.8-mmol/L. The patient had no history of diabetes mellitus, it was considered that hypoglycemia was related to tigecycline. Then tigecycline was discontinued and replaced by oral rifampicin 0.45 g thrice daily and an IV infusion of vancomycin 500-mg dissolved in 0.9% sodium chloride injection 100-ml once every 12-hours. Three days after tigecycline withdrawal, the patient′s blood glucose level was 3.0-mmol/L at dawn. Intravenous and oral glucose supplementation treatments were continued, and 19 days later, the patient′s fasting blood glucose level was 4.8-6.3-mmol/L.
  • Qiu Tingting, Kong Xianwei, Yan Yingying, Cheng Yinchu, Liu Bin, Zhou Xinghan, Yang Yiheng
    Adverse Drug Reactions Journal. 2021, 23(8): 403-407. https://doi.org/10.3760/cma.j.cn114015-20210204-00154
    Objective To construct an intelligent control system for narcotic drugs in the wards of Peking University Third Hospital and evaluate its implementation effect. Methods Based on the introduction of intelligent medicine cabinet, relevant software was developed to establish an intelligent control system for narcotic drugs, which connected with the intelligent medicine cabinet and hospital information system, and then formed an intelligent control system for narcotic drugs. In the control system, a remote database for essential narcotic drugs (essential drug database) in the wards was established and 2 closed-loop pathways for locking the batch number of narcotic drugs were designed according to whether the choice was essential drugs in the ward or drugs in the inpatient pharmacy. Based on the functional system of intelligent medicine cabinet, an intelligent management process for narcotic drugs was established, and process remode- ling was carried out in prescribing, prescription checking, drugs dispensing and distributing, and account registration, etc. The work efficiencies in remodeled processes before and after the implementation of the control system were compared. Results The intelligent control system for narcotic drugs was successfully constructed. The essential drug database was deployed in all wards of the hospital and the remote management in the whole hospital was realized. Two closed-loop pathways that could lock the drug batch number effectively controlled the first-in-first-out of narcotic drugs and solved the problem in batch number tracing of narcotic drugs. Thus the fine control of closed-loop batch number tracing, real-time counting, and accurate searching of narcotic drugs in the whole process from entering the drug storage to being used in patients was realized. Because of the establishment of intelligent management process, the manual procedures of doctors in prescribing and drug dispensing and distribution were avoided and the prescription checking procedure of pharmacist were simplified, thus the accuracy in prescribing, prescription checking, and drug dispensing and distribution was improved. The time consumptions for doctors in issuing orders and prescribing, nurses in handling problematic prescriptions, pharmacists in prescription checking and drug dispensing and distribution, and pharmacy inventory and booklet registration etc. were significantly less after the implementation of the control system than before (all P<0.001), and the work efficiency was obviously improved. Conclusion By constructing the intelligent management system for narcotic drugs in the hospital wards, the full-process closed-loop traceable management for narcotic drugs with traceable sources and whereabouts and accoun- tability in the whole hospital has been preliminarily realized, and the work efficiency has been obviously improved.
  • Li Danni, Liang Hui
    . 2017, 19(1): 59-60.
    An 11-year-old boy with Philadelphia chromosome positive acute lymphoblastic leukemia received dasatinib 60 mg once daily because of the resistance to imatinib. About five hours after drug administration, he developed generalized myalgia and ostealgia, lip edema and rash in the hands. An IV infusion of dexamethasone 3 mg and oral ibuprofen 200 mg were given, then the symptoms were mitigated. The above mentioned symptoms reappeared after the use of dasatinib the next day. The patient received dexamethasone and ibuprofen, the symptoms were relieved. Adverse reactions induced by dasatinib was considered. The dasatinib was stopped. Two days later, the patient received dasatinib at the same dosage as before and intensive treatment with vindesine, idarubicin, pegaspargase and dexamethasone, no symptoms recurred.
  • Wang Jian, Lin Xiaolan, Xu Huifang, Zhang Feng, Song Juexian, Chen Xintong, Zhang Peng, Dang Xiaofang, Zhuang Wei
    . 2017, 19(1): 65-66.
    A 20-year-old female patient took warfarin regularly at a dose of 3.75 mg once daily for sinus thrombosis and the INR value between 1.50 and 1.90. Headache was brought under control and no bleeding tendency existed. In order to further alleviate the symptoms, the patient was given decoction of traditional Chinese medicine for activating the blood. On day 4, the patient had epistaxis. On the next day, the patient started having gingival bleeding and the INR value was 2.06. The traditional Chinese medicine usage and dosage remained unchanged and the dosage of warfarin decreased to 3.00 mg/d, and then bleeding did not recur. Eighteen days later, the INR value was 1.56 and the patient had no any complaints.
  • Sun Shiguang, Fan Wei, Qi Dongmei, Liu Jian, Tian Yuejie, Xie Yanjun, Sun Rong
    . 2016, 18(4): 243.
    ObjectiveTo explore the clinical characteristics and the warning signals of Danshen lyophilized powder injection (DLPI).MethodsThe adverse drug reaction (ADR) reports of DLPI from the ADR Spontaneous Reporting Database of Shandong Province from January 1, 2005 to December 31, 2015 were collected. The clinical characteristics of ADR were analzed by descriptive statistical method. The conceptual data and the data for each year from 2005 to 2015 were analyzed to find out the warning signals of ADR induced by DLPI by the methods of proportional reporting ratio (PRR), reporting odds ratio (ROR), and bayesian confidence propagation neural network (BCPNN).ResultsA total of 887 reports and 887 patients which comprised 460 males and 427 females with the average age of (57.7±16.6) years (3 d to 91 years) were enrolled into the analysis. The patients  whose age ≥45 years accounted for 79.59% (706/887). There were 1 281 times of ADR in 887 patients which involved mainly in skin and cardio-cerebrovascular system. Top ten in turn were erythra, pruritus, dyspnea, shiver, nausea, headache, fever, palpitation, dizziness, and injection site reactions, totally 1 152 times of ADR which accounted for 65.89% (1 152/1 281). The patients stopped to use DLPI when the ADR appeared. Of the 887 patients, 557 cases were recovered and 330 had improvement after receiving the symptomatic treatments. The results of analysis on conceptual data and the data for each year by methods of PRR, TOR, and BCPNN showed that erythra (PRR method: conceptual data, from 2008 to 2015; ROR method: conceptual data, from 2008 to 2014; BCPNN method: conceptual data), pruritus (PRR method: conceptual data, 2012, 2013, 2015; ROR method: conceptual data, 2012, 2013), dyspnea (PRR method: conceptual data, from 2008 to 2014; ROR method: conceptual data, from 2008 to 2014; BCPNN method: conceptual data, 2014), shiver (PRR method: conceptual data, from 2007 to 2009; ROR method: conceptual data, from 2011 to 2013; BCPNN method:conceptual data, 2012 and 2013) could be  warning signals of ADR induced by DLPI.ConclusionsADRs due to DLPI involve mainly skin and cardio-cerebrovascular system. Erythra, pruritus, dyspnea, and shiver can be the warning signals of ADR induced by DLPI.
  • . 2017, 19(4): 241.
  • 病例报告
    Gao Ling;Yang Xiaoqing
    . 2008, 10(6): 0-0.

    A 48yearold woman was given an IV infusion of cefoperazone/sulbactam 3 g dissolved in 0.9% sodium chloride injection 250 ml for treatment of bronchitis. The patient developed difficulty breathing, agitation, lips cyanosis, and unconsciousness with an unrecordable BP about 10 minutes after starting the infusion. Cefoperazone/sulbactam was discontinued immediately. Despite treatment with oxygen inhalation, adrenaline, dexamethasone, and hydrocortisone, she died.

  • 抗菌药应用
    . 2005, 7(2): 118-124.
  • 调查研究
    Zheng Ping;Zhou Fan;Wen Yunheng
    . 2008, 10(6): 0-0.
    Objective: To investigate the causes of cefradineinduced hematuria in children. Methods: Clinical data from 19 children with hematuria induced by cefradine use in the community from March 2005 to March 2008 were collected. The patients’ sex and age, clinical presentation, dosage and administration of cefradine, the onset time, intensity and outcome of hematuria were investigated and analyzed. Results: Of the 19 children, 16 were males, 3 were females, and their age was ≤ 1 year (3 cases), ~3 years (10 cases), ~7 years (4 cases), and >7 years (2 cases). The routine dosage of cefradine was 50~100 mg/(kg·d) dissolved in 100~250 ml of sodium chloride 0.9% or glucose 5% for an IV infusion. Sixteen patients received 100 mg/(kg·d). One patient received 110 mg/(kg·d), two patients received <100 mg/(kg·d).The daily dosage was used as a single dose in 17 patients. Of the 19 patients, 17 developed gross hematuria and two developed microscopic hematuria. Laboratory tests showed RBC (+++~++++)/HP and urinary protein <0.1 g/24 h. Sixteen patients (84.2%) had normal renal function and 3 patients (15.8%) had mild elevation in SCr and BUN levels. Eighteen patients (94.7%) developed hematuria within 24 hours after receiving drug therapy. One patient’s hematuria onset was over 24 hours. After drug withdrawal, gross hematuria disappeared within 1~2 days and microscopic hematuria disappeared within 3~5 days. At 3month followup after discharge, their routine urine and renal functions normalized. Conclusion: Hematuria following an IV infusion of cefradine in childnen might be linked to the factors of large dose, high concentration, and young age.
  • 调查研究
    Zhao Chunjing①;Jiang Chengli①;Cao Yali②
    . 2004, 6(4): 235-239.
    Objective: To analyse the characterization of adverse reactions to beta-lactam antibiotics for rational drug use. Methods: 133 case reports of ADR associated with beta-lactam antibiotics were collected and analysed by Chongqing ADR Monitoring Center. Results: 26 drugs were involved in 133 ADR case reports, including ceftriaxone sodium (37 cases,constituting 27.82% of all cases), benzylpenicillin(20 cases,15.04%)and cefotaxime sodium(12 cases, 9.02%). There were 18 cases of type A reaction and 115 cases of type B reaction, among them allergic reactions in 98 cases(73.68%). Serious reactions amounted to 15 cases, of which 1 case died. Conclusion: Rational use of beta-lactam antibiotics should be emphasized in the clinical practice in order to prevent and reduce the occurrence of ADRs.
  • Li Yue, Han Qiuyuan, Liu Yang, Hou Guiying, Yao Zhipeng, Wang Xiaoyao, Wang Hongliang, Gao Yang
    Adverse Drug Reactions Journal. 2020, 22(10): 579-580. https://doi.org/10.3760/cma.j.cn114015-20191211-01016
    A 61-year-old man developed nausea, vomiting, unconsciousness, and limb convulsions after 1 hour of mistaken ingestion of European waterhemlock (Radix Archangeliae Decurrentis). Laboratory tests showed white blood cell count (WBC) 21.5×109/L, alanine aminotransferase (ALT) 246-U/L, total bilirubin (TBil) 35.3-μmol/L, creatine kinase MB (CK-MB) 20.8-μg/L, lactate dehydrogenase (LDH) 525-U/L, serum creatinine (Scr)143-μmol/L, uric acid 1-338 μmol/L, and blood ammonia 45-μmol/L. Chest compu- ted tomography showed multiple ground glass density lesions in bilateral lungs. The patient was diagnosed as having acute and severe European waterhemlock poisoning, toxic encephalopathy, aspiration pneumonia, and pulmonary edema. The treatments including ventilator assisted breathing, analgesia and sedation, anti-infection, expectorant and antiasthmatic, inhibition of gastric acid secretion, rehydration hydration, promotion of awakening, liver protection, and myocardial nutrition were given. In addition, the patient received 2 times of hemoperfusion. Five days later, the patient′s condition was improved. Laboratory tests showed WBC 12.0×109/L, ALT 94-U/L, TBil 28.2-μmol/L, CK-MB 2.7-μg/L, LDH 452-U/L, Scr 61 μmol/L, uric acid 514-μmol/L, blood ammonia 38.0-μmol/L. Then the patient was transferred to the Department of Emergency Internal Medicine for further treatment.
  • Adverse Drug Reactions Journal. 2020, 22(3): 180-187. https://doi.org/10.3760/cma.j.cn114015-20200214-00113
    目的 挖掘洛匹那韦/利托那韦(LPV/r)不良事件(AE)的风险信号,探讨LPV/r的临床安全性,为该药在新型冠状病毒肺炎(COVID-19)治疗中的安全应用提供参考。 方法 采用报告比值比法(ROR)对美国食品药品管理局不良事件报告系统(FAERS)2010年第1季度至2019年第3季度AE报告数据中LPV/r相关的风险信号进行挖掘,检测阈值为报告数大于3且ROR的95%置信区间(CI)下限大于1的AE,并对AE采用国际医学用语词典(MedDRA)的首选系统器官分类(SOC)和首选术语(PT)进行统计和分类,选取AE报告数和信号强度排名前50位的PT进行分析。 结果 2010年第1季度至2019年第3季度FAERS数据库共收到LPV/r为首要可疑药物的AE报告13-335例,检测出报告数>3且ROR的95%CI下限>1的AE风险信号455个,涉及AE报告7-718例。涉及AE报告数占比居前2位的系统器官依次为“各类损伤、中毒及手术并发症”[13.6%(1-051/7-718)]和“妊娠期、产褥期及围产期状况”[11.7%(899/7-718)],但在“各类损伤、中毒及手术并发症”所涉及的1-051例AE报告中与妊娠期药物暴露有关者为998例,占95.0%;信号数占比居首位的系统器官为“各种先天性家族遗传性疾病”[16.3%(74/455)]。另外,药物相互作用所致AE共144例,在AE报告数中排第7位。 结论 检测出LPV/r妊娠期用药相关胎儿、新生儿和婴儿异常等风险信号,提示应关注孕妇和婴幼儿使用LPV/r的风险。LPV/r与其他药物联用时的相互作用也值得关注。
  • 调查研究
    Ma Jianli;Wang Shiling; Zhou Liang;Zhang Wanxia
    . 2002, 4(2): 83-86.
    Objective: To analyze ADR reports of 163 cases from January 1998 to June 2001 in our hospital. Method: The ADR reports were classified by a descriptive research method.Results: 124 drugs were involved in these reports. In 85 cases only one drug was used and in other 78 cases more than one drug were in combination. As for intensity of ADR, there were severe 22, moderate 82, mild 59; and according to causality of ADR, certain 9, probable 114, possible 36, unlikely 4. 133 patients were symptomati-cally treated, the remaining not. 130 patients fully recovered, 31 turned for the improvement and 2 died. The leading cause of ADR was antibiotics (53.89% ) . Impairment of skin and its appendages was most commonly experienced (71.34% ) .Conclusion: Great concerns should be attached to the ADR monitoring in keeping abreast of the medical treatment in order to use the drugs safely and effectively.
  • . 2017, 19(1): 6-9.
  • . 2017, 19(5): 323.
  • . 2016, 18(4): 241.
  • 安全用药
    . 2006, 8(1): 28-30.
    吉非替尼是一种口服选择性表皮生长因子受体酪氨酸激酶抑制剂,可单药用于晚期非小细胞肺癌(NSCLC)患者经化疗后继续恶化的治疗。临床研究表明吉非替尼单独应用具有明显抗肿瘤活性,可使症状减轻。吉非替尼的主要不良反应包括痤疮样皮疹、恶心、呕吐、腹泻、皮肤干燥、间质性肺炎等。多数于停药后或经对症处理即可缓解,间质性肺炎虽然罕见却可致命,值得临床高度重视。
  • 安全合理用药
    Wu Guohao
    . 2008, 10(4): 0-0.

    Albumin, the major protein involved in maintaining colloid osmotic pressure in the blood, has been used in conditions such as burns, severe acute loss of albumin, and acute hypovolaemic shock. However, a variety of inappropriate use of albumin has been widely present in clinical practice recently, such as supplying nutrition, enhancing immunity, promoting wound healing, and expanding or maintaining blood volume in the routine treatment of fluid depletion. Actually, despite of the increase in serum albumin level, the use of albumin can not improve the therapeutic effects for original disease, reduce the incidence rate of complications, and improve clinical prognosis. One study reported that the increased deaths were 6 cases for each 100 critically ill patients using albumin, and it might be linked to increased mortality. In addition, there was no evidence that albumin administration reduces mortality in critically ill patients with hypovolaemia, burns, or hypoproteinemia. At present, the generally acknowledged indications of albumin in clinical practice are as follows: 24 hours after large area burns, acute traumatic shock, acute respiratory distress syndrome, blood replacement therapy, renal dialysis, severe hypoproteinemia and ascites, acute liver failure with hepatic coma.

  • Zhang Ailing, Qin Guijun, Meng Haiyang, Liu Yanxia, Zhang Xiaojian
    . 2015, 17(5): 357.
    Drug-induced gynecomastia with the benign enlargement of male breast glandular tissue was reported to cause an imbalance between estrogen and androgen action then lead to an increased estrogen to androgen ratio by drugs. Drugs are estimated to cause about 10%~25% of all cases of gynecomastia. Some commonly used drugs, such as spironolactone, ketoconazole, imatinib, bicalutamide, finasteride, cimetidine can cause gynecomastia. Clinical manifestations of drug-induced gynecomastia cause breast pain, tenderness or galactorrhea. Estradiol and estriol increased, while luteinizing hormone (LH), follicle stimulating hormone (FSH), and testosterone decreased in the laboratory tests. In the patients with drug-induced gynecomastia the causative medications should be withdrawn; if gynecomastia persists, the patients can be treated with tamoxifen. Surgery can be performed if treatment with tamoxifen was not effective or the clinical manifestations persist for one year.
  • 专题讲座
    . 2006, 8(3): 206-209.
  • 综述
    Jiang Yuyong;Cai Haodong
    . 2014, 16(3): 163-5.
    Tenofovir is a new class of nucleotide reverse transcriptase inhibitor with effective for treating HIV-infection and chronic hepatitis B. The potential renal toxicity of tenofovir is related to renal excretion. Renal histopathology revealed tubular injury. The main clinical manifestations of renal damage are decreased phosphorus and increased serum creatinine, and Fanconi syndrome, interstitial nephritis and acute renal failure may also develop. The bone toxicity of tenofovir is secondary to renal toxicity. The clinical manifestations include muscle weakness, bone pain and bone fracture. Tenofovir caused kidney-bone damage are associated with underlying diseases, gene polymorphism, plasma drug concentration and drug interactions. Patients taking tenofovir should be regularly monitored for renal function and electrolyte. The hypophosphatemia were treated with phosphate supplementation. The drug dosage should be adjusted when creatinine clearance rate is <50 ml/min. Renal function was improved markedly after tenofovir withdrawal in some patients, but part of patients progressed to chronic kidney disease.
  • Tang Wen, Jiang Chunyan, Sun Ying, Zhao Zhen, Ma Qing
    Adverse Drug Reactions Journal. 2020, 22(1): 12-19. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.01.004
    Objective To explore the short-term prognosis and influencing factors of oral voriconazole in elderly patients with invasive pulmonary fungal infection (IPFI). Methods By searching hospital information system in Beijing Friendship Hospital, Capital Medical University, the medical records of elderly patients (≥80 years) who were diagnosed as IPFI and treated with oral voriconazole in Department of Geriatrics from January 2016 to December 2017 were collected and analyzed retrospectively. The basic information, basic diseases, combined medication, baseline value of liver and kidney function, treatment course of oral voriconazole, and liver and kidney function and survival status within 30 days after medication were recorded. The influencing factors of all-cause liver injury, acute renal injury (AKI), and death within 30 days after oral voriconazole were analyzed by multivariate logistic regression. The odds ratio (OR) and its 95% confidence interval (CI) were calculated. Results A total of 34 patients were entered, including 20 males and 14 females with age of (91±5) years. Of them, 6 patients (17.6%) developed liver injury, 7 patients (20.5%) developed AKI, and 9 patients (26.5%) died within 30 days after treatment with oral voriconazole. Multivariate logistic regression analysis showed that age was an independent risk factor for liver injury within 30 days after treatment with oral voriconazole (OR=1.33, 95%CI: 1.03-1.73, P=0.03), baseline estimated glomerular filtration rate (eGFR)<60-ml/(min·1.73 m2) was an independent risk factor for AKI (OR=13.00, 95%CI: 1.27-133.29, P=0.03), AKI was an independent risk factor for death within 30 days (OR=48.00, 95%CI: 4.21-547.18, P<0.01). Conclusions The risk of liver injury, AKI, and death was higher within 30 days after oral administration of voriconazole in elderly patients with IPFI. Age and baseline eGFR<60-ml/(min·1.73 m2) were independent risk factors for liver injury and AKI, respectively. AKI was an independent risk factor for death.
  • 论著
    HE Qian;XIE Li-jing;Ma Pei-bin;SUN Cheng-ye
    . 2013, 15(1): 6-5.
    ObjectiveTo understand the current situation of poisoning caused by poisonous animals, poisonous plants, and poisonous mushrooms in our country in order to understand the direction of work for controlling poisoning caused by poisonous organisms and to provide scientific basis for the research on key technique for controlling poisoning.MethodsChina Hospital Knowledge Database and Wanfang Database were searched, and published literature regarding poisoning cases or events caused by poisonous animals, poisonous plants, and poisonous mushrooms in 1994-2011 was collected. The data was analyzed using retrospective descriptive epidemiological methods.ResultsThree thousand four hundred and sixty-three articles consistent with the criteria were collected and a total of 94 700 poisonous patients were reported, of which 46 110 were produced by poisonous animals, 37 172 produced by poisonous plants, and 11 418 produced by poisonous mushrooms. Poisoning mainly occurred in the south area which was abundant in various species and the case distribution was nearly consistent with that of the species. The spectrum of poison were relatively concentrated in several families, and in the number of poisoning cases caused by the top 5 poison categories, poisonous animals and poisonous plants accounted for 78.77%(36 321/46 110) and 84.03%(31 234/37 172) of total number of poisoning cases caused by the 2 kinds of poisonous organisms, respectively. The main categories of poisonous animals causing poisoning were toxic snakes, fish gall bladder, and puffer fish and main plants; the main categories of poisonous plants causing poisoning were Leguminosae and Ranunculaceae. Most poisonous mushrooms poisoning was due to unknown species which accounted for 77.09% (8802/11 418), and Amanitaceae and Boletaceae were the most common mushrooms in known poisonous mushroom poisoning. The main causes of poisoning were accidents (50.24%, 41 291/82 185) and mistaken ingestion (42.19%, 34 670/82 185) and the main route of intoxication was oral ingestion (70.34%, 66 438/94 458). The case fatality rates due to poisonous animals, poisonous plants, and poisonous mushrooms were 252%(1008/39 951), 1.66% (547/33 001), and 12.39%(1248/10 076), respectively.ConclusionsPoisoning of poisonous plants, poisonous animals, and poisonous mushrooms could cause serious damage and was characterized by higher fatality rate, significant regionalism, and relatively concentrated poisonous spectrum. Therefore, from now on, the work for controlling poisoning caused by poisonous plants, poisonous animals and poisonous mushrooms should be enhanced; surveillance system should be established; studies on the key technique for controlling poisoning should be conducted; propaganda and education on the identification, hazards, prevention of poisons should be strengthened in order to minimize the incidence of poisoning.
  • Wang Binxia, Duan Lufen, Lu Jian, Zhuang Zhiwei, Yuan Yunlong, Wu Jing, Cao Fan, Shi Lu, Xu Jinhui, Li Jingjing, Zhou Qin, Tang Lian
    Adverse Drug Reactions Journal. 2022, 24(4): 185-191. https://doi.org/10.3760/cma.j.cn114015-20211125-01190
    Objective To explore the risk factors of linezolid-induced thrombocytopenia (LIT) and evaluate their predictive value. Methods Medical records of hospital acquired pneumonia (HAP) patients who admitted in Suzhou Municipal Hospital from July 2019 to October 2021 and received linezolid were collected and retrospectively analyzed. Clinical data including general information, comorbidities, linezolid application, laboratory test results, and trough concentration of linezolid was extracted. Patients were divided into LIT group and non-LIT group according to the occurrence of LIT. Clinical characteristics were compared between the 2 groups; risk factors of LIT in patients with HAP were analyzed using a binary logistic regression model, and the odds ratio (OR) and its 95% confidence interval (CI) were calculated; the predictive value of the risk factors for LIT were evaluated using receiver operating characteristic (ROC) curve. Results A total of 74 patients were included in the study, including 55 males and 19 females, aged 82 (73, 88) years. LIT occurred in 25 patients (33.8%). Compared with the non-LIT group, the age and trough concentration of linezolid in patients in the LIT group were higher [88 (81, 92) years vs. 79(70, 86) years, P=0.001; (19.6±10.3) mg/L vs. (9.8±6.4) mg/L, P<0.001], and the baseline platelet count and baseline creatinine clearance rate were lower [181(162, 212)×109/L vs. 229 (169, 289)×109/L, P=0.025; 31(19, 44) ml/(min·1.73 m2) vs. 46 (27, 65) ml/(min·1.73 m2), P=0.018]. Binary logistic regression analysis showed that the lower baseline creatinine clearance rate (OR=0.974, 95%CI: 0.951-0.998, P=0.035) and higher trough concentration of linezolid (OR=1.156, 95%CI: 1.059-1.261, P=0.001) were independent risk factors for LIT in HAP patients. ROC curve analysis showed that the threshold of the age, trough concentration of linezolid, baseline platelet count, and baseline creatinine clearance rate were 87 years (sensitivity 56.0%, specificity 83.7%), 15.4-mg/L (sensitivity 64.0%, specificity 87.8%), 189×109/L (sensitivity 67.3%, specificity 68.0%), and 45-ml/(min·1.73 m2) (sensitivity 53.1%, specificity 80.0%), respectively. Patients were respec- tively divided into 2 groups according to the thresholds and the incidences of LIT were compared. The results showed that the incidences of LIT in patients with age and trough concentration of linezolid exceeding the thresholds and in patients with baseline plate count and baseline creatinine clearance rate lower than or equal to the thresholds were significantly higher than those in the other patients (all P<0.01). Conclusions Baseline creatinine clearance rate, trough concentration of linezolid, age, and plate count are risk factors for LIT in HAP patients and their thresholds are 45-ml/(min·1.73 m2), 15.4-mg/L, 87 years, and 189×109/L, respectively. These risk factors have good predictive value for the occurrence of LIT.
  • Li Na
    . 2015, 17(5): 361.
    Sunitinib is one of the targeting multiple receptor tyrosine kinase inhibitors. Sunitinib is used to treat advanced renal cell carcinoma, and refractory gastrointestinal stromal tumor patients with which are intolerant or resistant to imatinib. The common adverse reactions of sunitinib include fatigue and weakness, mucocutaneous adverse reactions (hand foot skin reaction, changing in skin color, hair depigmentation, splinter hemorrhages, stomatitis, and lipsotrichia), adverse reactions in cardiovascular system (hypertension, left ventricular ejection fraction decrease with or without symptoms, heart failure), and hypothyroidism etc. The mechanism of fatigue and weakness may be related to the inhibition of adenosine monophosphate-activated protein kinase, inducing hypoxia, influence of glucose transport, and decreased capability of glucose uptake. The mechanism of adverse reactions in mucocutaneous tissues may be related to the inhibition of vascular endothelial growth factor and platelet-derived growth factor, blocking the activation of melanocyte microphthalmia associated transcription factor, inhibition of signal transduction and activators of transcription 3, promoting the expression of Fas/Fas L, and inducing the mitochondrial injury. The mechanism of adverse reactions in cardiovascular system may be related to the off-target effects to heart platelet-derived growth factor receptor and the inhibition of heart angiogenesis, the inhibition of ribosomal protein S6 kinase and AMP dependent protein kinase, inducing the mitochondrial injury, and he inhibition of nitric oxide production. The mechanism of hypothyroidism due to sunitinib may be related to the decrease of  the blood supply of thyroid and inhibition of the activity of thyroid peroxidase induced by antiangiogenesis of sunitinib.
  • 安全合理用药
    Zhang Haiying;Lv Xin;Li Yuzhen
    . 2008, 10(5): 0-0.

    Microecology is a branch of vital science for research in the relationship of microorganisms with the hosts. Recently, microecological preparations are emerging in large numbers with the advance of microecology. The microecological preparations can regulate microecosystem dysbiosis, maintain microecosystem balance, and confer a health benefit on the host. The microecological preparations can be classified into three types: probiotics (live microorganisms), prebiotics (nondigestible food ingredient), and synbiotics (a mixture of probiotics and prebiotics). The indications for microecological preparations are diarrhea (including diarrhea in children, antibioticassociated diarrhea, and traveller's diarrhea), irritable bowel syndrome, inflamematory bowel disease, Helicobacter pylori infections, constipation, cirrhosis, allergy, and female genital urinary tract infections. The microecological preparations are relatively safe. However, the microecological preparations containing live microorganisms should be used in caution in patients with hypoimmunity or impaired intestinal mucosal barrier in order to avoid opportunistic infections occurring. General precautions for the use of microecological preparations are as follows: the tablet/capsule should be swallowed with warm water (at a temperature under 40℃); bismuth preparations, tannic acid, activated charcoal, tincture, and certain antibiotics in combination with microecological preparations comprising live microorganisms should be avoided; the microecological preparations should be preserved in lightprotected containers and kept in cool place.

  • 安全用药
    . 2003, 5(1): 21-23.
    目的:探讨丁卡因表面麻醉所致全身不良反应的病因、预防和处理方法。方法:回顾性总结11例不良反应者的临床表现、处理措施和预后,提出合理的防治方法。结果:11例不良反应者通过应急措施(吸氧、静脉输液、肌注和静注地塞米松等),全部抢救成功,无1例发生意外。结论:丁卡因不良反应发生与用药过量,患者对药物低耐量以及患者精神紧张有关,严格控制药物用量,适当应用镇静药和在丁卡因溶液中加入适量的肾上腺素等措施可以预防不良反应的发生。
  • 安全用药
    . 2004, 6(3): 163-166.
    近年来,国内外有关药物引起急性胰腺炎的报道有所增加。本文介绍引起或有可能引起急性胰腺炎的药物,并对其发病机制、诊断和防治进行探讨,旨在引起对药物性胰腺炎的关注,以降低其发生率。
  • 综合报道
    . 1999, 1(3): 169-172.
    据近年国内期刊有关报道,探讨抗变态反应药引起变态反应的问题。临床报告涉及的药物均为组胺H1受体拮抗剂;不良反应表现为皮肤反应、支气管哮喘、过敏性紫癜、过敏性休克。它们引起的过敏反应常易与原发症状混淆,临床应予注意。
  • Liang Haixia, Zhou Jianbo, Zhang Shengpeng, Zhu Ying, Song Zhihui
    . 2017, 19(1): 67-68.
    A 52-year-old female patient with hypertension and diabetes mellitus had mild and moderate arterial lesions of bilateral lower extremities. The computed tomographic angiography (CTA) was performed to clarify the degree of vascular stenosis. Before examination, this patient′s blood pressure was 135/73 mmHg. She was given intraarterial iopamidol [37 g(I) /100 ml] 65 ml. About one hour after the intraarterial injection, she experienced dizziness, nausea, vomiting and fatigue, her blood pressure increased to 183/93 mmHg. After taking antihypertensive drugs for about one hour, those symptoms relieved and blood pressure was 150/90 mmHg. At about 5.5 hours, the above clinical symptoms reappeared and blood pressure rose to 260/120 mmHg. Urapidil 100 mg was administered through continuous intravenous pump and the pump speed was 3.0-6.0 mg/h. After 3.5 hours of treatment, the blood pressure decreased to 160/80 mmHg and the clinical symptoms of dizziness, nausea and vomiting disappeared. Therefore urapidil was stopped and captopril 12.5 mg was temporarily orally administered. Though the constant adjustment of antihypertensive therapy, the patient′s blood pressure was stable at 140-150/70-80 mmHg.
  • Su Xiancai, Zhang Mingyuan, Chen Ting,Lai Xiaozheng
    Adverse Drug Reactions Journal. 2020, 22(5): 327-328. https://doi.org/10.3760/cma.j.cn114015-20181206-01216
    A 45-year-old female patient received oral methimazole and propylthiouracil for hyperthyroidism. The drug was discontinued 2 weeks later due to methimazole-induced agranulocytosis. About 1 month later, the patient was re-given methimazole 10-mg thrice daily according to the doctor′s instructions and advice. She developed high fever and chills about 2 hours after the first administration and half on after the second administration, respectively, with a maximum body temperature of 39.5-℃. The laboratory tests showed WBC 5.99×109/L, neutrophil 0.91, C-reactive protein 2.3-mg/L, and negative bacterial blood culture. Drug fever caused by methimazole was considered. Methimazole was stopped and symptomatic treatment was given. Four and a half hours later, the patient′s body temperature dropped to 36.5-℃. At 1 year of follow-up, the patient did not take methimazole again, and neither high fever nor chills recurred.
  • Wang Xin, Yan Suying, Cai Haodong
    Adverse Drug Reactions Journal. 2020, 22(11): 609-612. https://doi.org/10.3760/cma.j.cn114015-20200929-01003
    Medication errors have become a serious public health problem. Elderly patients have the highest incidence of medication errors. The risk factors of medication errors in elderly patients include suffering from more co-existing diseases, multiple drug use (including high-alert drugs), liver and kidney dysfunction, cognitive impairment, and living alone. The common types of medication errors in elderly patients include drug omission, failure to take medicine according to the scheduled time, wrong medication method, repeated medication due to forgetting, over dose medication, mistakenly taking drugs prohibited to be taken at the same time, and etc. Clinicians and pharmacists should participate in the medication management in the elderly patients together. Clinicians should strengthen communication with patients when prescribing prescriptions and pharmacists should strengthen the prescription review, so as to improve their medication compliance. It is suggested that medication education in the elderly patients should be patiently carried out with oral and written forms, electronic equipment could be used to help remind elderly patients of medication, and the family members of elderly patients with memory impairment should be asked to participate in the medication management.
  • 病例报告
    Wang Hongtao;Yang Wei;Sheng Qiuju;Wang Yunxiu;Liu Zhuogang;Li Yingchun;Liao Aijun
    . 2008, 10(6): 0-0.
    Two patients receiving highdose methotrexate chemotherapy developed acute renal failure.Patient 1, a 53-year-old woman with nonHodgkin lymphoma, received highdose methotrexate chemotherapy. Initially she was infused with methotrexate 500 mg intravenously within half an hour, followed by 3500 mg via infusion pump within 24 hours. Then calcium folinate was given for rescue. The first dose of calcium folinate was 30 mg/m2, followed by 15 mg/m2 intramuscularly once every 6 hours for 8 doses. The patient had no history of chronic renal disease. Her renal function was normal before chemotherapy (SCr 97.1 μmol/L, BUN 4.78 mmol/L). On day 4 after chemotherapy, she developed mild edema of the face and both hands, and oliguria; her SCr increased to 151 μmol/L. Methylprednisolone, furosemide, and calcium carbonate and vitamin D3 were given; her urinary alkalinisation and monitoring of renal function were performed (a peak SCr level of 275 μmol/L). On day 13 after chemotherapy, her renal function returned to within normal range (SCr 96 μmol/L).Patient 2, a 29-year-old man with acute lymphoblastic leukemia, received highdose methotrexate chemotherapy. Initially he was infused with methotrexate 500 mg intravenously within half an hour, followed by 4500 mg via infusion pump within 24 hours. The regimen of rescue was the same as patient 1. The patient had no history of chronic renal disease. His renal function was normal before chemotherapy (SCr 86.9 μmol/L, BUN 5.35 mmol/L). On day 3 after chemotherapy, he developed generalized edema and oliguria; his SCr increased to 235 μmol/L (peak level 360 μmol/L). The symptomatic treatment was given (the regimen was the same as patient 1). On day 30 after chemotherapy, his renal function returned to within normal range(SCr 89 μmol/L).
  • Zhang Xiaoni, Ren Xiudong, Dai Lingling
    Adverse Drug Reactions Journal. 2022, 24(2): 98-100. https://doi.org/10.3760/cma.j.cn114015-20210330-00391
    A 55-year-old male patient with rectal adenocarcinoma received oxaliplatin (200-mg intravenously infused on day 1) and capecitabine (1-500-mg orally twice daily from day 2 to 15) after operation, and 21 days was a cycle. Next day after the first intravenous infusion of oxaliplatin and before capecitabine administration, the patient developed fatigue, nausea, lower limb muscle soreness, muscle weakness, and dark urine. Laboratory tests showed creatine kinase (CK) 1-453-U/L, myoglobin>1-000-μg/L, urea nitrogen 50.0-mmol/L, serum creatinine (Scr) 192-μmol/L, uric acid 1-071-μmol/L, blood sodium 123-mmol/L, blood phosphorus 4.36-mmol/L, and bicarbonate 5.0-mmol/L. Blood gas analysis showed pH 7.3, carbon dioxide partial pressure (PCO2) 19-mmHg, partial pressure of oxygen (PO-) 110-mmHg, lactic acid 1.5-mmol/L, and base excess -15.5-mmol/L. Rhabdomyolysis, acute renal injury, electrolyte disorder, and metabolic acidosis combined with respiratory alkalosis were diagnosed, which were considered to be related to oxaliplatin. Nutritional supportive treatments, rehydration, alkalinized urine, correction of electrolyte disorders, correction of acidosis, and other treatments were given. On day 2 of treatments, the patient′s lower limb muscle soreness was relieved. On day 3, the lower limb muscle soreness subsided and the muscle strength returned to normal. On day 4, laboratory tests showed CK 73-U/L, CK-MB 1.0-μg/L, myoglobin 51-μg/L, urea nitrogen 4.8-mmol/L, Scr 66-μmol/L, uric acid 179-μmol/L, sodium 134-mmol/L, and phosphorus 0.43-mmol/L; blood gas analysis showed pH 7.4, PCO2-35-mmHg, PO- 100-mmHg, lactic acid 1.2-mmol/L, and base excess -1.3-mmol/L.
  • Wang Meiyun, Sun Zhener, Yang Xiayan, Ma Fang
    Adverse Drug Reactions Journal. 2023, 25(7): 424-429. https://doi.org/10.3760/cma.j.cn114015-20221221-01158
    Objective To observe the effect of acupressure and ear acupoint pressure bean on alleviating the adverse reactions of polyethylene glycol electrolyte powder in patients undergoing colonoscopy, and analyze the effect on patients' medication compliance and intestinal cleanliness. Methods The study was designed as a prospective, single-center, randomized controlled clinical trial. The subjects were selected from patients who planned to undergo colonoscopy in the Endoscopy Center of the Affiliated Hospital of Hangzhou Normal University and were divided into trial group (50 patients) and control group (50 patients) in terms of random number table method. Patients in the control group was given colonoscopy routine nursing, and those in the trial group was treated with acupressure and ear acupoint pressure bean therapy on the basis of routine nursing. The incidence of adverse reactions of polyethylene glycol electrolyte powder, medication compliance (8-item Morisky medication adherence scale), and intestinal cleanliness (Boston bowel preparation scale) in patients were compared between the 2 groups. Results A total of 100 patients were included initially, 8 fell off during the study, and 92 were finally entered in the analysis, including 46 in the trial group and control group respectively. There were 26 males and 20 females in the trial group, aged (47±6) years with a range from 35 to 56 years, and 25 males and 21 females in the control group, aged (46±6) years with a range from 33 to 57 years. Differences in age, gender, education level, and marital status of patients between the 2 groups were not significant (all P>0.05). The overall incidence of adverse reactions of polyethy- lene glycol electrolyte powder in the trial group was lower than that in the control group [30.4% (14/46) vs. 65.2% (30/46), χ2=11.152, P=0.001]. Adverse reactions in the trial group included nausea (11 cases), fullness (2 cases), and abdominal pain (1 case), while those in the control group included nausea (17 cases), fullness(5 cases), abdominal pain (4 cases), vomiting (2 cases), anal discomfort and rash (1 case each). The scores of 8-item Morisky medication adherence scale and Boston bowel preparation scale in the trial group were both higher than those in the control group [8 (7, 8) points vs. 6 (6, 6) points, χ2=-7.711, P<0.001; 9 (8, 9) points vs. 7 (7, 7) points, χ2=-6.721, P<0.001]. Conclusion The addition of acupressure and ear acupoint pressure bean to the routine nursing process in colonoscopy can effectively alleviate the adverse reactions of polye-thylene glycol electrolyte powder, and improve patients' medication compliance and intestinal cleanliness.
  • Liu Qingyang, Bai Xiangrong, Wang Ke, Su Su, Chu Yanqi, Zeng Yan, Tang Jing, Shen Jianghua, Zhang Qingxia, Liu Yang, Yang Jun, Wang Hailian, Jiang Dechun, Yan Suying
    Adverse Drug Reactions Journal. 2021, 23(3): 120-127. https://doi.org/10.3760/cma.j.cn114015-20201105-01105
    Objective To establish a drug-related problems (DRPs) classification system for outpatients and home patients and provide healthcare staff with tools for standardized recording of DRPs. Methods DRPs classification systems-related literature were collected by searching foreign databases. The selected DRPs classification systems were compared and analyzed, and the initial DRPs classification system was formed by integrating the characteristics of pharmaceutical care for outpatients and home patients in China. The expert consultation form of DRPs classification system was made, expert consultation was performed for 2 rounds using Delphi method, and the final DRPs classification system was formed through modification and adjustment according to expert opinions. Results A total of 25 DRPs classification systems were obtained, of which 16 were selected and then integrated to form the initial version of the DRPs classification system. The primary structure of the initial DRPs classification system consisted of 5 parts: problem state, problem type, problem cause, problem intervention, and intervention result. Each part had different number of items, among which there were different number of secondary structure items in problem cause, problem intervention, and intervention result. In the first round of consultation, 32 experts were invited and 30 consultation forms were collected, with a recovery rate of 94%. In the second round of consultation, 30 experts were invited and 30 consultation forms were collected, with a recovery rate of 100%. After 2 rounds of consultation, the acceptance rates of experts for the question state, problem type, problem cause, question intervention, and intervention result in the primary structure were 100%, 90%, 83%, 83%, and 97%, respectively. For the evaluation of 5 categories of drug treatment (indications, effectiveness, safety, economy, and compliance) in DRPs classification system, except for that the expert authority coefficient of economics was 0.79, the expert authority coefficient of the other 4 categories of issues was all >0.8. In the first and second round of consultation, the coordination coefficient of expert opinions was 0.386 (χ2=995.258, P<0.001) and 0.364 (χ2=971.232, P<0.001), respectively. After modifying with expert opinions, a final version of DRPs classification system was formed, which included 38 primary structure items in 5 categories and 90-secondary structure items in 3 categories. Conclusion A DRPs classification system for outpatients and home patients suitable for China′s national conditions has been initially established, which can be used as a standardized recording tool for DRP.
  • Wang Dongxue, Hou Jiqiu, Xu Feng
    Adverse Drug Reactions Journal. 2020, 22(10): 581-582. https://doi.org/10.3760/cma.j.cn114015-20191213-01055
    A 39-year-old male patient took orlistat 0.12 g thrice daily for weight loss. More than 4 months after medication, he developed muscle soreness of limbs and weakness of both lower limbs, with lower limb muscle strength at grade 3. Laboratory tests showed alanine aminotransferase (ALT) 65-U/L, aspartate aminotransferase (AST) 125-U/L, myoglobin>3-997-μg/L, creatine kinase (CK) 2-889-U/L, CK-MB (CK-MB) 71-U/L, serum creatinine (Scr) 1-418-μmol/L, urine protein (+++), and urine occult blood (+). Rhabdomyolysis caused by orlistat was considered. Orlistat was stopped and symptomatic treatments such as rehydration, alkaline urine, and diuretics were given. Seven days later, the patient′s symptoms were improved and the muscle strength of his lower limbs returned to grade 4. Laboratory tests showed ALT 52-U/L, AST 68 U/L, myoglobin 1-737-μg/L, CK 475-U/L, Scr 657-μmol/L, urine protein (+), and urine occult blood (-). One month later, the muscle strength of his lower limbs returned to grade 6. Laboratory tests showed ALT 35-U/L,AST 38-U/L, myoglobin 624-μg/L, and CK 192-U/L. The symptoms of myalgia and weakness of lower limbs did not recur.
  • DID讲座
    . 2006, 8(4): 288-291.
  • Liu Fang, Li Yun, Zhao Rongsheng
    Adverse Drug Reactions Journal. 2021, 23(11): 561-563. https://doi.org/10.3760/cma.j.cn114015-20211117-01170
    With the promotion of innovative medical models such as patient-centered multidiscip- linary team (MDT), more and more pharmacists are playing an important role. Owing to their education background, knowledge structure, and professional sensitivity, pharmacists pay more attention to the prevention of the adverse drug reactions/adverse events. They work closely with other medical staffs and support each other in the team to improve the safety of drug therapy in difficult and complex cases through medication reconciliation, participation in development of treatment strategy, carrying out pharmaceutical care, and patient education, etc. Pharmacists should actively participate in MDT, explore and establish standardi- zed pharmaceutical care process and mode, carry out relevant clinical studies, summarize and share experience in time, so as to promote the sustainable development of pharmaceutical care in MDT and give full play to the role in ensuring medication safety in patients.
  • Qi Bingli, Ma Yanli, Liu Shikai
    Adverse Drug Reactions Journal. 2022, 24(12): 670-672. https://doi.org/10.3760/cma.j.cn114015-20220328-00257
    A 51-year-old patient with yolk sac tumor received BEP regimen [intramuscular injection of bleomycin 30-mg, on day 2, 9, and 16), IV infusions of etoposide 100-mg/(m2· d) and cisplatin 20-mg/m2 on day 1 to 5] after comprehensive staging surgery for ovarian cancer, 21 days was a cycle. No interstitial changes in her lungs were found on chest CT before operation and before each chemotherapy cycle. On the 12th day of the 4th treatment cycle, the patient developed cough, expectoration. Laboratory tests showed white blood cell count 0.63×109/L, neutrophil count 0.16×109/L, hemoglobin 82-g/L, platelet count 42×109/L. Chest CT showed a little grid shadow in both lungs. The patient was diagnosed with myelosuppression (grade Ⅳ) and pulmonary infection. Bleomycin treatment in the 3rd week of the 4th cycle was stopped. Granulocyte colony stimulating factor, thrombopoietin, meropenem, bromhexine, blood transfusion, fluid infusion, and other symptomatic and supportive treatment were given. Bone marrow suppression was relieved, but cough and expectoration were aggravated. Chest CT showed a little grid shadow in both lungs. Glucocorticoid and amphotericin B were added, and non-invasive ventilator assisted ventilation and other symptomatic support treatments were given, but the patient′s condition worsened, and respiratory failure and death occurred 45 days after the 4th cycle of chemotherapy.
  • 综合报道
    . 2002, 4(4): 238-240.
  • Wei Huabo, Li Bo, Li Xia, Dong Yang
    Adverse Drug Reactions Journal. 2020, 22(12): 709-710. https://doi.org/10.3760/cma.j.cn114015-20200203-00082
    A 56-year-old male patient with advanced hepatocellular carcinoma received targeted therapy with lenvatinib 12-mg once daily. After 30 days of medication, the patient developed epistaxis without predisposing factors in the morning, which occurred once every half a month and could be stopped after compression. The drug was not stopped. After 97 days of medication, the patient developed abdominal pain. Physical examination showed abdominal tenderness, especially in the upper and middle abdomen, rebound pain, and muscle tension. Abdominal CT examination showed pneumoperitoneum, hydrops, and perforation of hollow organs of abdomen. Lenvatinib was withdrawn and the conservative treatments with fasting, gastrointestinal decompression, anti-infection, acid suppression, and rehydration were given. After 22 days of treatments, his abdominal pain was relieved and the fluid diet was restored. After 26 days of treatments, the patient had exhaust and defecation. After that, the patient took lenvatinib with the same dose as before by himself again for one week, and epistaxis recurred. There was no epistaxis after discontinuation of lenvatinib again. It was considered that epistaxis and perforation of hollow organs might be related to lenvatinib.
  • 论著
    Ye Lm①;Ren Yu①;Li Yi①;Song Hao①;Lj Ningning①;Chu Zhengzheng①;Xiong Ying①;②
    . 2005, 7(6): 411-417.
    Objective: To evaluate the safety of terazosin tamsulosin finasteride and their combination for the treatment of benign prostatic hyperplasia. Methods: Correlative databases websites and medical journals were searched for the randomized clinical trials (RCTs) controlled clinical trials(CCTs) cohort studies and case reports about the serious adverse events available. The quality of the literature was evaluated the data were extracted and meta-analyzed if appropriate or otherwise would be described. Results: Nine RCTs one CCTs and three other studies met the inclusion criteria. The meta-analysis suggested that tamsulosin had a better safety profile than terazosin in the occurrence of dizziness headache orthostatic hypotension and discontinuations due to adverse reactions. There was no statistic difference between terazosin and tamsulosin in the occurrence of other adverse events. By comparison with finasteride terazosin caused more dizziness and there was no statistic difference between terazosin and finasteride in the occurrence of impotence and decreased libido. Tamsulosin and finasteride were compared in only one trial so a meta-analysis could not be done. However the results of this trial indicated that tamsulosin seemed to be safer than finasteride. Two studies compared terazosin and finasteride with their combination and found contradictory conclusions. Conclusion: According to the analysis it is concluded that tamsulosin may have a better safety and acceptability profile than terazosin. There is not enough evidence of finasteride causing more impotence and decreased libido. The safety of tamsulosin and finasteride can not be made definitely because of the insufficiency of information.
  • 安全用药
    . 2004, 6(2): 97-101.
    近年,卡马西平临床严重不良反应时有报道,本文通过检索1994年-2003年国内相关文献,就其主要报道进行归纳,并探讨在护理工作中,如何加强对卡马西平不良反应的防治。
  • 调查研究
    Sun Zhenxiao;Zhang Li
    . 2010, 12(1): 26-5.
    Objective: To investigate the clinical features and causes of liver damage related to Polygonum multiflorum and its preparations in order to provide the preventive measures. Methods:The Chinese Journal Fulltext Database, Chinese Biomedical Literature Database, and Chinese Scientific and Technical Periodicals Database were searched, and the case reports of Polygonum multiflorum and its preparationrelated liver damage published in domestic literature from 1996 to 2009 were collected. The baseline characteristics of the patients, the situation of drug use, the clinical features, prognosis, and outcome of the liver damage were analysed. Results:A total of 35 patients had liver damage related to Polygonum multiflorum and its preparations. They comprised 20 men and 15 women with average age of (362 ±13.7) years. Of them, 14 received Chinese patent medicine alone, 18 received herbal pieces alone, and 3 received both Chinese patent medicine and herbal pieces. Among the patients receiving herbal pieces, 6 received raw herbal pieces, 2 received processed herbal pieces, and the others were not stated. Of the 35 patients, 18 experienced liver damage again after drug readministration, 3 might have a familial tendency to develop this disorder. The time to liver damage onset after drug administration was as follows: the shortest was 3~6 days, the longest was > 3 months, and the most was 1~4 weeks. The main clinical presentations were jaundice and abnormal liver function. The case reports of having records of liver function tests were as follows: the ALT levels in 31 patients were 102~4 584 U/L, the average level was 1 153.1 U/L; the AST levels in 25 patients were 61.5~1 937 U/L, the average level was 657.4 U/L; the average TBil levels in 29 patients were 134.9 μmol/L; the average DBil levels in 23 patients were 97.9 μmol/L. The patients with mild symptoms spontaneously recovered after drug discontinuation. Most patients were cured after receiving liverprotective treatment. Of the 35 patients, 2 improved and 33 were cured. Conclusion:Both raw and processed Polygonum multiflorum and its preparations may induce liver damage. The patients’previous history and family history of Polygonum multiflorum use should be reviewed before drug administration, the correct dose should be chosen, and the patients’liver function should be monitored during polygonum multiflorum use.
  • 中毒救治
    . 2002, 4(5): 318-319.
    我院自1997年以来收治42例斑蝥中毒患者,其中毒表现主要为胃肠道刺激症状;食道及胃灼痛感,恶心、呕吐,水样便或血便;神经系统:头痛、头晕,瞳孔散大,视物不清;沁尿系统:尿频、血尿及急性肾功能衰竭。经积极救治,42例中40例治愈,2例死亡。
  • 综述
    . 2000, 2(2): 76-80.
    万古霉素以其对耐甲氧西林金葡球菌(MRSA)的良效而著称,关注其不良反应并尽量避免其发生是合理用药内容之一。本文对与万古霉素相关的红人综合征(RMS)的国内外文献进行综述。多数报道认为:RMS是在快速静脉输注万古霉素的过程中发生的、由组胺介导的一种反应。此反应以脸、颈及躯干上部斑丘疹样红斑为特征。本文对其发生机制及发生率的不同看法根据文献进行了分析,亦介绍了发生RMS后的处理方法与预防措施。
  • 综合报道
    . 2000, 2(1): 41-44.
    本文根据近年来的文献综述了药物引起的皮肤色素沉着。引起皮肤色素沉着的药物有抗精神病药、抗菌药、降血压药、抗心律失常药、抗癌药等。药源性皮肤色素沉着,可能与药物的用量及应用时间有关。因此,应严格掌握药物的使用剂量及使用时间,以避免或降低药物不良反应的发生。
  • . 2017, 19(3): 161.
  • 综述
    . 2006, 8(4): 244-247.
    对利巴韦林的致癌、致畸和致突变作用进行了文献分析及评价,为合理安全用药提供了依据。
  • 调查研究
    Lai Shu;He Sheng
    . 2001, 3(2): 80-83.
    Objective: To make clear of the phenomenon of contradictory effects of drugs. Methods: 57 cases of AIAS published in Chinese medical periodicals during 1984 - 1998 were retrieved and analysed. Results: The shock appeared in most of cases within 30 minutes, especially within 5 minutes, after administration, accounting for 98.25% and 68.42% respectively, and resulted in 2 deaths. Conclusion: Antiallergics can cause anaphylactic shock and it is important for doctors to both get the knowledge of and pay attention to it in clinical practice in order to reduce the misdiagnosis and mistreatment of AIAS.
  • Adverse Drug Reactions Journal. 2020, 22(3): 147-150. https://doi.org/10.3760/cma.j.cn114015-20200219-00135

     国家卫生健康委员会颁布的《新型冠状病毒肺炎诊疗方案(试行第四版)》中指出,针对重型和危重型患者可使用肠道微生态调节剂维持肠道微生态平衡,预防继发细菌感染,但缺乏具体使用信息。益生菌是目前应用最广的肠道微生态调节剂,对不存在益生菌制剂使用禁忌证的新型冠状病毒肺炎重症患者,结合现有证据,临床可酌情使用益生菌制剂,可优先考虑使用在其他研究中有一定有效性和安全性证据的益生菌,告知患者正确服用的方法和服用时间,避免抗菌药物等对益生菌作用的影响,并注意监护益生菌潜在的感染风险。

  • Yuan Xiyue, Chen Jihui, Zhou Jia
    Adverse Drug Reactions Journal. 2022, 24(10): 528-533. https://doi.org/10.3760/cma.j.cn114015-20220124-00069
    Objective To understand the pre-warnings of drug dosage errors in medical advices in elderly inpatients with renal insufficiency by the prescription review system. Methods The pre-warnings of drug dosage errors in medical advices in ≥65 years old inpatients with renal insufficiency by the prescription review system in Xinhua Hospital Affiliated to Shanghai Jiao Tong University Medical College from January 1, 2021 to December 31, 2021 were reviewed, and the reasons for the wrong pre-warnings were analyzed. In the correct pre-warnings, the drugs involved in dosage errors related to kidney and the types of errors were evaluated, and the departments related to the occurrence of errors and the acceptance of physicians for pre-warnings were analyzed. Results A total of 511 medical advices on pre-warnings related to drug dose in ≥65 years old patients with renal insufficiency were included in the analysis. One hundred and eighty-three medical advices (35.8%) were evaluated as wrong pre-warnings, and 328 (64.2%) were correct pre-warnings. The medical advices with correct pre-warnings involved 25 kinds of drugs, of which the most involved drugs was antibacterial drugs [57.62%(189/328)]; the second was cardiovascular system drugs [24.70% (81/328)], among which trimetazidine tablets was the most common. Among the correct pre-warnings, 315 (96.04%) were excessive dose, and 13 (3.96%) were insufficient dose. The most common error content of excessive dose was "excessive single dose and excessive daily dose" (53.33%, 168/315), followed by "high frequency, excessive daily dose" (41.59%, 131/315); the most common errors of insufficient dose was "low frequency, insufficient daily dose" (9/13). A total of 186 (56.7%) medical advices were corrected by physicians after accepting the pre-warnings, and 142 (43.3%) were not. The acceptance rate of surgeons for pre-warning of wrong orders was higher than that of physicians, with a statistically significant difference [73.3%(96/131) vs. 45.7%(90/197), P<0.001]. Conclusions The effect of pre-warnings from the prescription review system on dosage errors related to kidney is positive. It is necessary to further improve the accuracy of the prescription review system for the dosage errors related to kidney, improve the acceptance of clinicians, and ensure the safety of patients.
  • Pang Lili, Yang Wanna, Hou Fengqin
    . 2016, 18(3): 163.
    ObjectiveTo compare and analyze the clinical characteristics of elderly and non-elderly patients with drug-induced liver injury (DILI).MethodsThe clinical characteristics of elderly (≥60 years old) and non-elderly (<60 years old) patients with DILI who sought medical advice in section for outpatients or hospitalized in Department of Infectious Diseases, Peking University First Hospital from January 1997 to September 2015 were analyzed retrospectively.ResultsThe elderly group comprised 193 patients [female:121(62.7%)] with average age of (69±7)years. The non-elderly group comprised 286 patients [female: 192(67.1%)] with average age of (43±12)years. The time from medication to the appearance of liver injury in the elderly group was 14-60 days (the median time 30 days) and the non-elderly group was 10-60 days (the median time was 30 days)(Z=-1.267, P=0.205). There were 132 cases (68.4%) with the symptoms of weakness, 121 cases (62.7%) with yellow urine, 118 cases (61.1%) of jaundice, 33 cases (17.1%) had fever in the elderly group, respectively. There were 189 cases (66.1%) with the symptoms of weakness, 182 cases (63.6%) had yellow urine, 179 cases (62.6%) had jaundice, 46 cases (16.1%) had fever in the elderly group, respectively. There were no significant differences in incidence of the symptoms mentioned above between the two groups (all P>0.05). The differences of peak values of alanine aminotransferase, alkaline phosphatase, and total bilirubin between the two groups were not statistically significant (all P>0.05). The case number of antinuclear antibody-positive in the elderly group were more than those in the non-elderly group[27(9.4%)](P<0.001). There were 221 kinds of suspected drugs which [47(24.4%)] may cause DILI in the elderly group. The top three were traditional Chinese medicine (107, 48.4%),cardiovascular agents (31,14.0%) and antimicrobial agents (18, 8.2%). There were 316 kinds of suspected drugs which might cause DILI in the non-elderly group. The top three were traditional Chinese medicine (154, 48.7%), antimicrobial (50, 15.8%), and non-steroidal anti-inflammatory drug (23, 7.3%). The number of  cases with DILI types of hepatocellular, cholestatic, and mixed in the elderly group and the non-elderly group were 157(81.4%), 13(6.7%), 23(11.9%) and 238(83.2%), 25(8.7%), 23 (8.1%), respectively. The differences were not statistically significant. The cases number of DILI classification of 1, 2, 3, 4, and 5 in the elderly group and the non-elderly group were 56(29.0%), 31(16.1%), 99(51.3%), 5(2.6%), 2(1.0%) and 65(22.7%), 37(12.9%), 174(60.9%), 4(1.4%), 6(2.1%), respectively. The differences were not statistically significant. The suspicious drugs were withdrawn and all the patients with DILI received the anti-inflammatory and hepatoprotection therapy after the appearance of clinical symptom. There were 14 cases in the elderly group and 34 cases in the non-elderly group received steroid therapy additionally. The course of disease in the elderly group were 27-78 days, the median time was 47 days. The course of disease in the non-elderly group were 30-87 days, the media time was 54 days (P=0.07). Of 193 patients in the elderly group, 176 cases (91.2%) were cured and improved, 14 cases (7.2%) developed chronic DILI, and 3 cases (1.6%) died. Of 286 patients in the non-elderly group, 254 cases (88.8%) were cured and improved, 24 cases (8.4%) developed chronic DILI, 7 cases (2.4%) died, and 1 case received liver transplantation. The difference of prognosis between the two groups were not statistically significant (P=0.856).ConclusionsThe traditional Chinese medicines and cardiovascular agents are the main drugs which due to DILI in elderly patients, the traditional Chinese medicines and antimicrobial are main drugs which due to DILI in non-elderly patients. In addition to the cases of accompanying with autoimmune phenomena in the elderly group are more than those in the non-elderly group, the clinical manifestations, treatment, and prognosis are similar in the elderly and non-elderly patients.
  • 论著
    Wang Shuzhen;Liu Hui;Zheng Junfu;Zhang Xin;Li Bing;Li Lei;Ding Huiguo
    . 2014, 16(5): 269-5.

    Objective To compare the clinical characteristics between the children and adults patients with drug-induced liver injury (DILI).Methods"Drug-induced liver injury" was selected as the key word and all the medical records in Beijing You′an Hospital Medical Records Management Center from February 2002 to June 2011 were collected. The patients who were ≤14 years were enrolled into the child group. The patients who were ≥15 years were enrolled into the adult group. The medical records of patients in the two groups were collected and analyzed retrospectively. The main analysis parameters included use of medication, clinical manifestation, and clinical pathological classification of DILI.ResultsThe main drugs which can cause DILI in child group were antibacterial drugs (13 cases, 42%), traditional Chinese medicines (9 cases, 29%), and antipyretic analgesics (6 cases, 19%). The main drugs which can cause DILI in the adult group were traditional Chinese medicines (79 cases, 69%), antipyretic analgesics (12 cases, 11%), and antibacterial drugs (8 cases, 7%) . Twenty-six patients (84%) in the child group and 114 patients (100%) in the adult group developed weak, loss of appetite, aversion to fats, nausea, vomiting and yellow urine 3 to 90 days[mean(18±15)days]and 5 to 90 days[mean(30±20)days] after drug admission, respectively. Part of patients developed fever, erythema and increased eosinophils. There were no significant differences in the levels of serum alanine transaminase (ALT), aspartate aminotransferase (AST), and glutamyltranspetidase between the two groups. But the level of serum alkaline phosphatase (ALP) in the child group was higher than that in the adult group (P<0.05). The number of mixed DILI, hepatocellular DILI and cholestasis DILI were 15 (48.4%), 8 (25%) and 8 (25%) cases in 31 patients in the child group, respectively. The number of hepatocellular DILI, mixed DILI, and cholestasis DILI were 69 (60.5%), 26 (22.8%) and 19 (16.7%) cases in 114 patients in the adult group, respectively. The proportion of mixed DILI in child group was significantly higher than that in the adult group (P<0.01). The proportion of hepatocellular DILI in the child group was significantly lower than that in the adult group (P<0.01). The drugs were withdrawn immediately after the symptoms of DILI appeared in the patient in the two groups. All the patientsion the adult group and 27 children in the child group were improved and discharged. There were 2 cases with depravation of primary diseases, 1 case discharged himself and 1 case died due to hepatic failure in the child groupConclusionsThe main drugs causing DILI are different in children and adult; in children, antibacterial drugs , while in adults traditional Chinese medicine mainly. The mainly liver injury type in children is mixed DILI. The mainly liver injury type in adults is hepatocellular DILI. It should be vigilant towards DILI when the child or adult treated with antibiotics or traditional Chinese medicine.

  • . 2015, 17(3): 161.
  • Zhou Jiancheng, Zheng Ping
    Adverse Drug Reactions Journal. 2020, 22(12): 699-700. https://doi.org/10.3760/cma.j.cn114015-20200402-00346
    A 19-year-old male patient received diuretics, cardiac function improvement, anti- infection, and liver-protective treatments for heart failure and various co-existing diseases. Ivabradine 2.5-mg twice daily was given due to his higher heart rate [90-110 beats per minutes (bpm) ], but the heart rate did not decrease (94-110 bpm). The dose of ivabradine was increased to 5-mg twice daily after 3 days of medication and the heart rate decreased slowly. After 3 days of ivabradine dose-increase, the heart rate of the patient was 71-89 bpm. On the 4th day, the patient ate about 200 g of pomelo. After that, his heart rate continued to decrease, which was 50 bpm on the 6th day. Bradycardia caused by ivabradine was considered and the drug was stopped. The heart rate of patient was 76-131 bpm 3 days after the drug withdrawal. Changes of heart rate of the patient before and after eating the pomelo suggested that there might be food-drug interaction between pomelo and ivabradine.
  • 学术讨论
    . 2000, 2(2): 113-118.
    合理用药已经是医药专业人员非常熟习的名词。但在国内论及该主题的文献中,介绍合理用药的实践经验和案例者比比皆是,而在理论的系统性和概念的完整性方面显得较为薄弱。笔者在参考大量中外相关文献的基础上,结合多年对该主题的教学心得,拟从理论研究的角度,给“合理用药”以明确的定义,解析用药合理化的评价指标,提炼合理用药概念的特点,阐述促进全社会合理用药的意义,并从药师在临床用药中作用和职责的渐变,划分合理用药在认识论上的发展过程。
  • 论著
    Luo Leiming;Yang Xue;Shi Jun;Zhu Bing;Zhu Qiwei;Fan Li
    . 2005, 7(3): 165-168.
    Objective:The effects of carvedilol on renal function in chronic heart failure(CHF) patients with chronic renal failure (CRF) was estimated. Methods: 27 CHF patients with CRF were chosen to receive carvedilol in association with routine treatment for heart failure. The changes of left ventricular ejection fraction (LVEF) and parameters of renal function were recorded and analyzed in various phases. Results: The LVEF at the end of third and twelveth months after therapy were higher than at basic line(all p<0.01). The serum creatinine increased one month after therapy(p < 0.05), but decreased subsequently under basic line either at the end of third month or twelveth month(all p< 0.05). Similarly, endogenous creatinine clearance rate(Ccr)decreased at the end of first month(p< 0.05), and then exceeded basic level at the end of third month or twelveth month(all p< 0.01). However, the microalbuminuria and total urine protein within 24 hours were not altered after therapy…更多 at any phases (all p> 0.05). Conclusion: Carvedilol, the third generation of beta-blocker, may induce transient decrease of renal function, but can improve heart function and renal function in CHF patients with CRF.
  • 调查研究
    Liu Lirongv①;Wu Tao①;Zhan Siyan①;Wu Ye②;Guo Xiaoxin②
    . 2006, 8(3): 184-187.
    The meta-analysis results of the efficacy and safety of ribavirin were reviewed. In comparing to interferon mono-therapy,the combined therapy of interferon and ribavirin had higher efficacy and higher incidence of adverse reactions in treatment of chronic hepatitis C. The efficacy of ribavirin for treating infant respiratory syncytial virus infections was not sufficiently proved,so it is necessary to conduct a larger randomized controlled trials for ribavirin.
  • 病例报告
    Chen Hui;Zhu Wei;Lian Shi
    . 2008, 10(6): 0-0.
    A 78yearold woman was hospitalized with cerebral hemorrhage, right central hemiparalysis and pulmonary infection. On day 21 after admission, her urine and stool examinations showed fungal spore and hyphae. She was considered to have fungal infections. The woman received an IV infusion of fluconazole 0.4 g daily on day 1 of therapy, followed by fluconazole 0.2 g daily. Three days later, she developed an erythematous macular eruption with mild pruritus on her chest and abdomen. Fluconazole was stopped and changed to an IV infusion of itraconazole 0.25 g twice daily. Two days later, her erythematous macular eruption with marked pruritus progressed to cover her trunk and extremities. Itraconazole was discontinued and replaced with an IV infusion of allimin and oral chlorphenamine. Five days later, her skin eruption basically subsided.
  • Cui Xiangli, Guo Heng, Wang Xiaojian, Wang Weina, Shen Su
    Adverse Drug Reactions Journal. 2020, 22(9): 545-547. https://doi.org/10.3760/cma.j.cn114015-20190731-00625
    Three patients (patient 1, a 48-years-old male; patient 2, a 65-years-old female; patient 3, a 58-years-old female) received clozapine for schizophrenia at daily doses of 200-mg, 175-mg, and 100-mg, respectively. Patient 1 developed venous thrombosis of lower limbs after 16 years of clozapine treatment, which was improved after thrombolytic therapy. Ten years later, the patient developed shortness of breath after activity and the symptom gradually worsened. Bilateral pulmonary embolism was diagnosed by computed tomographic pulmonary angiography (CTPA), and warfarin and rivaroxaban were given successively for anticoagulation. One year later, the patient developed cardiac insufficiency. The patient was diagnosed as having chronic thromboembolic pulmonary hypertension (pulmonary artery systolic pressure was 86-mmHg), chronic cor pulmonale, and cardiac insufficiency. Warfarin combined with cardiac glycosides, diuretics, and other symptomatic treatments were given. After 3 months of treatments, his dyspnea was markedly relieved and the pulmonary systolic pressure was reduced to 48-mmHg. Patient 2 developed pulmonary embolism after 5 years of clozapine treatment. After thrombolytic therapy, he was given oral warfarin and the drug was discontinued by himself 3 years later. Pulmonary embolism recurred 2 years after the drug withdrawal. Nadroparin calcium and warfarin anticoagulation was given successively and 3 months later, CTPA showed that pulmonary embolism basically disappeared. Patient 3 developed lower-extremity venous thrombosis after 2 years of clozapine treatment, and pulmonary embolism occurred 1 year later, which was improved after anticoagulation, diuretics, and other treatments. Three years later, the patient stopped warfarin by herself, and 10 months later, her pulmonary embolism recurred. Low-molecular-weight heparin sodium as bridge therapy to warfarin was given. Three months later, CTPA showed that pulmonary artery thrombosis basically disappeared.
  • 论著
    Su Yingying;Zhu Haiying
    . 2006, 8(5): 332-335.
    Objective: To analyze the effects of mannitol on the plasma osmolality and outcome in patients with brain injury. Methods: According to the plasma osmolality measured on admission and within two weeks after admission, the patients were divided into two groups: hyperosmolality group and hyposmolality group. Risk factors and outcome of short-term (30 days)were analyzed between the two groups. Results: Three hundred and six patients with bran injury were administered with mannitol used for dehydration and reduction of intracranial pressure. Of 90 patients with disturbance of plasma osmolality on admission, 72 had hyperosmolality and 18 had mild hyporsmolality. Of 216 patients with normal plasma osmolality on admission, 46 developed hyperosmolality and 6 occured mild hyposmolality within 2 weeks during the treatment of manmitol used for dehydration and reduction of intracranial pressure, and the rest maintained normal plasma osmolality. Single factor analysis showed that moderate or severe brain injury (GCS≤12), diabetes mellitus, nephropathy, and high dose of mannitol were significantly associated with plasma hyperosmolality. Multiple factor analysis showed, that, with the exception of nephropathy, risk of hyperosmolality to patients with moderate and severe brain injury was 2.6 times as high as those with mild brain injury, to diabetic patients was 2.2 times as high as the nondiabetic ones, to patients receiving mannitol > 100 g daily was 1.8 times as high as those receiving mannitol ≤100 g daily and to patients receiving > 1000 g total dose of mannitol was 2.6 times as high as those receiving ≤1000 g total dose of mannitol. The survival rate of 30 days in patients with plasma hyperosmolality (39.0%) was lower than that in patients without plasma hyperosmolatity (68.9%), and the difference was statistically significant (P<0.05). Conclusion: High daily dose or cumulative dose of mannitol could induce or aggravate the changes of plasma osmolality, and affect the survival rate of short-term in patients with brain injury.
  • 安全用药
    . 2004, 6(5): 317-319.
    本文对近年来有关克林霉素不良反应的文献资料进行归纳,其主要不良反应包括胃肠道反应、过敏反应和肝肾损害等。提示临床在用该药时严格掌握其适应证,采取正确的使用方法,并谨慎联合用药,以避免或减少不良反应的发生。
  • ADR监测
    . 2004, 6(6): 415-417.
  • Zhang Hongmei, Liu Guangchen, Tian Xu, Zhou Wei
    Adverse Drug Reactions Journal. 2020, 22(9): 533-534. https://doi.org/10.3760/cma.j.cn114015-20190722-00588
    A 32‑year‑old male patient received oral desloratadine citrate disodium tablets 8.8 mg once daily for allergic rhinitis. On the 6th day of medication, he developed sporadic red rashes on his abdomen, but he didn′t pay attention to it. On the 7th day of medication, the rashes increased and were with itching; urine color became dark brown; and he developed yellowish discoloration of hand skin and sclera. Laboratory tests showed alanine aminotransferase (ALT) 323 U/L, aspartate aminotransferase (AST) 186 U/L, gamma glutamyl transferase (γ‑GT) 309 U/L, total bilirubin (TBil) 63.9 μmol/L, and direct bilirubin (DBil) 33.6 μmol/L. He was diagnosed as having drug‑induced liver injury and allergic dermatitis, which were considered to be caused by desloratadine citrate disodium. Then the drug was stopped and the patient was given liver‑protective treatments and external application of mometasone furoate cream. On day 2 of desloratadine citrate disodium withdrawal, the color of his urine became lighter. On day 4 of drug withdrawal, the color of the rashes became lighter, the color of urine returned to normal, and there were no new rashes. On day 9 of drug withdrawal, the rashes disappeared basically. Liver function examination showed ALT 84 U/L, AST 29 U/L, γ‑GT 187 U/L, TBil 19.5 μmol/L, and DBil 8.0 μmol/L. Two weeks later, his ALT was 54 U/L, and other examination results were within the reference fange.
  • Shen Lili, Zhang Xinke, Fan Lujie, Li Xiaohua, Zhao Guoying
    Adverse Drug Reactions Journal. 2021, 23(5): 266-268. https://doi.org/10.3760/cma.j.cn114015-20201102-01107
    A 71-year-old male patient with severe stenosis of the right common carotid artery and internal carotid artery underwent aortography+cerebral arteriography+right internal carotid artery stenting under local anesthesia with contrast medium iodixanol injection. Head CT before operation showed no obvious abnormality. Ten hours after the operation, the patient developed neurological symptoms such as fever, drowsiness, choking in drinking water, incomplete motor aphasia, decrease of muscle strength and tension of left limb, convulsions, etc. Brain magnetic resonance imaging (MRI) showed increased signal intensity in the right cerebral sulcus and sulcus shallower. Contrast-induced encephalopathy caused by iodixanol was consi- dered. After 3 days of symptomatic treatments with rehydration, glucocorticoid, and mannitol, the patient′s symptoms were improved. Brain MRI showed that the hyperintensity of right cerebral cortex decreased and the sulcus gradually returned to normal.
  • Guo Zihan, Jiao Yuanyuan, Zhao Bingqing, Zhang Yanhua
    . 2015, 17(4): 282.
    Peripheral neuropathy (CIPN) induced by chemotherapy is the common dose-limiting adverse reactions of platinum, taxol and vinblastine. The mechanisms of CIPN due to platinum, taxol and vinblastine may be related to injury of dorsal root ganglion, inhibition of tubulin depolymerization and changing axonal transport, inhibition of association of tubulin from protein subunit, deletion of tubulin and dysfunction of axonal transport, respectively. Pain, numbness, acanthesthesia, burning sensation, sensory deprivation, myodynamia weakness or paralysation, constipation, sexual dysfunction, change of vision, and anaudia are the main clinical manifestations of CIPN. Usually, the amplitude and the conduction velocity of sensory nerve action potential are decreased, while the amplitude and the conduction velocity of motor nerve are normal or slightly changed before the clinical symptoms of CIPN appearance. The development of CIPN are related with sex (female), age (agedness), habits and customs (smoking history), tumor type (oophoroma),  primary disease and combination with neurotoxic drug. The more the chemotherapeutics accumulated dose is, the higher the incidence of CIPN. The shorter the administration interval of chemotherapy is, the higher the incidence of CIPN. There is no effective drug for prevention of CIPN at present. Duloxetine is the the only one drug recommended by American Society of Clinical Oncology for treatment of CIPN.
  • 安全用药
    . 2005, 7(1): 29-31.
    本文重点介绍了抗感染药物静脉滴注速度过快所致的不良反应,并就其不良反应发生的机制及防治方法进行探讨。旨在引起临床重视给药速度对患者用药安全性和有效性的影响,以减少不良反应的发生。
  • 论著
    Li Xiaohong;Ding Yan;Ma Junqi;Han Ying
    . 2008, 10(6): 0-0.
    Objective: To observe and evaluate the safety of levonorgestrelreleasing intrauterine system (LNG-IUS) in the treatment of endometriosis. Methods:A total of 59 patients with endometriosis were studied. The LNG-IUS was inserted into the uterine cavity. The acne, facial pigmentation, premenstrual mammary swelling, the body weight, and quality of life were scored and compared before and 6 months and 12 months after the insertion of the LNG-IUS. The adverse reactions to LNG-IUS were observed. Results: The acne scores before and 6 months after the insertion of the LNG-IUS were 1.00 (0.00, 3.00) and 0.00 (0.00, 2.00), respectively, the difference was not statistically significant (P>0.05); while the acne scores were 0.00 (0.00, 1.00) 12 months after the insertion of the LNG-IUS, the difference was statistically significant (P<0.01). The facial pigmentation scores before and 6 months and 12 months after the insertion of the LNG-IUS were 1.00 (0.00, 1.00); the differences were not stastically significant (all P>0.05). The premenstrual mammary swelling scores before and 6 months and 12 months after the insertion of the LNG-IUS were 220 (0.00, 4.00), 1.50 (0.00, 4.00) and 1.00 (0.00, 3.00), respectively; the differences were statistically significant (P<005, P<0.01). The body weight before and 6 months and 12 months after the insertion of the LNG-IUS were 59.00 (55.00, 64.00)kg, 59.50 (55.00, 64.00)kg, and 59.00 (54.00, 64.00)kg, respectively; the differences were not statistically significant (all P>0.05). The quality of life before the insertion of the LNG-IUS was compared with the quality of life 6 months and 12 months after the insertion of the LNG-IUS; the differences were statistically significant (all P<0.01). The intramenstrual bleeding before and 6 months and 12 months after the insertion of the LNG-IUS were 4 cases (6.78%), 16 cases (27.12%), and 14 cases (23.73%), respectively. Other adverse reactions to LNG-IUS were hair loss (1 patient) and a feeling of swelling over entire body (2 patients). Conclusion: Levonorgestrelreleasing intrauterine system is safe in treatment of endometriosis.
  • Adverse Drug Reactions Journal. 2020, 22(3): 205-210. https://doi.org/10.3760/cma.j.cn114015-20200304-00216
    儿童是新型冠状病毒的易感人群,易发生隐性感染。由于儿童群体的特殊性,疾病防控及诊疗工作面临着挑战。截至2020年2月29日,国内不同机构和学术团体已发布儿童新型冠状病毒感染防控/诊疗相关方案/建议/共识/指南(方案)29篇,其中防控方案17篇,防控和诊疗方案1篇,诊疗方案11篇。概括起来,儿童新型冠状病毒感染防控和诊治主要措施是:(1)严格按照“控制传染源”“阻断传播途径”“保护易感人群”的原则,在医院内、诊室和居家等场所执行隔离及防护、消毒措施,以有效防控儿童院内感染及家庭聚集性传播。(2)采取对症治疗为主,并避免滥用抗菌药物。(3)抗病毒治疗应根据患儿年龄、体重、临床分型、合并疾病等因素权衡利弊,发病早期推荐试用干扰素。(4)中医药治疗应遵循辨证论治的原则。(5)重症患儿可酌情采用糖皮质激素、丙种球蛋白、无带毒血浆治疗。
  • 安全用药
    HAN Yong-peng
    . 2012, 14(5): 299-3.
    Clinical presentations of oxaliplatin-induced anaphylactic reaction are respiratory tract symptoms, skin symptoms and other systemic symptoms. Hypersensitivity induced by oxaliplatin usually occurs after multiple treatment courses. The mechanisms of oxaliplatin-induced anaphylactic reaction may be associated with a high cytokine release. The risk and severity of oxaliplatin-induced anaphylactic reaction can be reduced by using allergy skin test, a slower infusion rate, a conditioning regimen and desensitization therapy.
  • 论著
    Sima Lei①*;Jia Liqun①;Yu Lili①;Pan Lin②;Guo Yanru②
    . 2007, 9(5): 320-323.
    Objective:To observe the influence of chronic oxaliplatin neurotoxicity on Nissl bodies and substance P in dorsal root ganglion in rats.Methods:Thirty Wistar rats were randomly divided into two groups:oxaliplatin group and control group.The rats in the oxaliplatin group were given oxaliplatin 4 mg/kg twice weekly by intraperitoneal injection for 9 times altogether.The rats in the control group were given the same volume of 5% glucose.50% paw withdrawal threshold(50% PWT)was measured 2 hours after each injection.The L5 dorsal root ganglion was sliced and stained 24 hours after the last injection.The morphology of dorsal root ganglion neurons,and the morphology and integrating optical density of Nissl bodies and substance P were observed.Results:50% PWT of rats in the oxaliplatin group decreased significantly after the third injection than that in the control group(P<0.01).Neuropathological examination showed,in comparison to the control group,the area of cyton,nucleus,and nucleolus In dorsal root ganglion diminished(P<0.05,P<0.01),the proportions of decentered nucleus and polynucleolus increased(P<0.01),the integrating optical density of Nissl bodies and substance P decreased(P<0.05,P<0.01).Conclusion:The peripheral neuropathy caused by oxaliplatin is related to the changes in Nissl bodies and substance P in dorsal root ganglion neuron.
  • Liang Yingqi, Chen Siying, Hou Pengcheng, Yang Ting, Yang Jun
    Adverse Drug Reactions Journal. 2023, 25(10): 629-632. https://doi.org/10.3760/cma.j.cn114015-20220708-00615
    A 77-year-old male patient with lung cancer developed creatine kinase (CK) 887 U/L, CK-MB 89 μg/L, and high-sensitivity troponin I (hs-TnI) 43-750.1-ng/L, and ECG showed multilead ST-segment elevation after 2 cycles of combination chemotherapy with camrelizumab. The patient did not undergo the 3rd cycle of anti-tumor treatment. Clinical pharmacists participated in consultations and assisted physicians in analyzing the patient′s medication. The causality between camrelizumab and the adverse event was considered as "possible" and the patient was diagnosed as immune myocarditis grade G3, receiving intravenous injection of 1-000-mg methylprednisolone pulse therapy once daily. Clinical pharmacists assisted physicians in reviewing data and developing glucocorticoid reduction plans. The dosage was reduced to 500-mg once daily after 2 days of pulse therapy. The patient′s myocardial enzymes continued to decrease after glucocorticoid reduction. After 3 days, the dosage of methylprednisolone was reduced to 40-mg by intravenous injection once every 12-hours for 7 days. The patient′s hs-TnI decreased to 2-248.6-ng/L. Methylprednisolone was changed to prednisone 40-mg twice daily orally. The physician’s advice for prednisone dose reduction: reduce the dosage by 10-20 mg per week, monitor myocardial enzymes every week, and when the dosage is reduced to 10 mg/d, and if the myocardial enzymes return to normal, maintain it for 1-2 weeks before discontinuation. The patient followed the doctor's advice and successfully stopped medication, and no glucocorticoid-related adverse reactions and cardiac discomfort recurred. The patient did not receive immunotherapy again.
  • 中毒救治
    Huang Jing①;Liu Fang①②;Zhai Suodi①②*
    . 2007, 9(4): 267-271.
    Sodium nitroprusside is a rapid and short-acting vasodilator.It is used in the treatment of hypertensive crises and severe heart failure.Sodium nitroprusside is rapidly metabolized into cyanide,which is further metabolized to thiocyanate.Therefore,cyanide poisoning or thiocyanate intoxication from their accumulation may occur with high-doses,prolonged administration of sodium nitroprusside.Should the patients develop metabolic acidosis,central nervous system depression,and cardiovascular instability that may consider cyanide poisoning or thiocyanate intoxication,and sodium nitroprusside should be stopped immediately.The patients should be given systematic therapy and antidote.The common antidotes are sodium nitrite,methylthioninium chloride,sodium thiosulfate,and hydroxocobalamin.The thiocyanate concentrations should be monitored if treatment continues for over than 3 days,and cyanide concentrations should also be monitored.Cyanide toxicity from sodium nitroprusside may be prevented by concomitant administration of sodium thiosulfate.The patient with renal impairment may use fenoldopam to replace sodium nitroprusside.
  • Liu Ying, Liu Liping,Qin Wangjun,Mao Min
    . 2017, 19(1): 72-73.
    A 79-year-old female patient with type 2 diabetes was ordered to receive subcutaneous injection of biosynthetic human insulin injection 8 U [Novolin R 3 ml: 300 U (cartridge)] before 3 meals. Because of no matching insulin pen, the nurse used normal insulin syringe (40 U/ml, 0.2 ml contains common insulin injection 8 U) as a substitution of Novolin R insulin pen and gave the patient an injection of 0.2 ml Novolin R liquid (including Novolin R 20 U) according to her experience of using normal insulin syringe formerly. About 4 hours later, the patient developed sweating, coma, and no responses to call. Her fingertip blood glucose was 2.8 mmol/L. She received an intravenous injection of 50% glucose 40 ml immediately. About 10 minutes later, her fingertip blood glucose increased to 4.4 mmol/L. About 70 minutes later, her fingertip blood glucose increased to 6.0 mmol/L and her consciousness recovered.
  • 临床观察
    Zhang Xuesong;Jin Rui
    . 2008, 10(3): 180-4.

    Objective: To observe the myopathy following telbivudine alone and telbivudine plus adefovir or interferon administration and analyze its relative factors. Methods: Five patients with myopathy related to telbivudine alone and telbivudine plus adefovir or interferon in our hospital from January 2007 to January 2008 were investigated. The dosage and administration of the drugs, the clinical manifestation of myopathy, and the results of laboratory testing were analyzed. Results: The 5 patients were men aged 25~45 years. One patient received telbivudine 600 mg once daily for 1 month. One patient received telbivudine 600 mg twice daily for 2 months, and subsequent regimen was changed to telbivudine 600 mg once daily plus adefovir 10 mg once daily for 5 months. Three patients received telbivudine 600 mg once daily plus intramuscular injection of interferon 3×106 U every other day for 3~9 months, respectively. All five patients developed myalgia and generalized hypodynamia, and cardiac muscle was involved in one patient, and three patients presented with neurological disorders. Of 5 patients, 4 patients' CK levels were 311~900 U/L. Conclusion: Telbivudine alone and telbivudine plus adefovir or interferon might induce myopathy. And the dosage of telbivudine might be associated with the severity of myopathy in certain degrees.

  • 滥用误用
    Pang Yi;Wang Jinzhong;Qin Xiaolan
    . 2009, 11(1): 40-3.
    Both Chuanwu (parent root of Aconitum carmichaeli) and Caowu (tuberous root of Aconitum kusnezoffii) contain diterpenoid alkaloids, of which the main alkaloid is aconitine. Inappropriate use of Chuanwu or Caowu may cause intoxication. Oral aconitine 3 to 5 mg may produce fatalities. This paper reports a case of Chuanwu and Caowu decoctioninduced cardiotoxicity. A 42yearold man developed numbness of the extremites, palpitation, chess distress, and dizziness one hour after taking 1 000 ml of a decoction prepared from Chuanwu 30 g and Caowu 30 g for external application by mistake. One hour and half , the patient presented with ventrcular extrasystole. He underwent gastric lavage, and received IV furosemide and IV omeperazole. After two hours, he developed mild coma, and muscular tremor. His heart rate was 209 beats/min, and his BP was 67/25 mm Hg. An ECG revealed ventricular tachycardia and ventricular fibrillation. IV amiodarone, IV lidocaine, and IV atropine were given. After 3 hours, laboratory testing revealed the following values: WBC 12.4×109/L, Hb 152 g/L, AST 812 U/L, and ALT 205 U/L. An ECG showed frequent ventricular extrasystole, paroxysmal ventricular tachycardia. Treatment included administration of dexamethasone, dopamine, lidocaine, Shengmai injection, Dahuang (rhubarb) decoction, and detoxication decoction prepared from black soybean, Fangfeng(ledebouriella root), mel, and Zhi Gancao (prepared liquorice). Six hours later, he became conscious. Three days later, an examination revealed HR 70 beats/min, R 17 times/min, SaO2 100%, AST 49 U/L,ALT 85 U/L. An ECG was normal. He was discharged 5 days later.
  • 安全用药
    . 2003, 5(3): 173-176.
    为了解别嘌醇的不良反应,检索《中国生物医学文献数椐库》1981~2002年间有关别嘌醇不良反应的文献进行分析。由别嘌醇引起不良反应的患者共151例,其中死亡22例(14.57%)。最常见的不良反应为皮疹,共132例(87.42%),其次是发热和肝肾损害。死亡率高,应引起注意。
  • Dong Yuan, Dong Zhiqiang
    Adverse Drug Reactions Journal. 2021, 23(2): 100-101. https://doi.org/10.3760/cma.j.cn114015-20200509-00504
    A 74-year-old male patient with gastric body adenocarcinoma received first-line, second-line, and third-line chemotherapy for 6, 8, and 4 cycles, respectively. Because of the poor effect of chemotherapy, the patient received targeted therapy with apatinib (750-mg orally, once daily). Eighteen days later, the patient developed fatigue and dizziness, and stopped the drug by himself. Laboratory test showed that platelet count (PLT) was 41×109/L. He was diagnosed as having grade 3 thrombocytopenia. Platelet-raising therapy was given immediately. After his PLT returned to 153×109/L, the dose of apatinib was reduced to 500-mg once daily. Twenty-one days later, the symptom of dizziness recurred and facial edema appeared. Laboratory test showed that PLT was 45×109/L. It was considered that thrombocytopenia was related to apatinib and dose-dependent. Platelet-raising therapy was given again. Thirteen days later, his PLT returned to 214×109/L and an intermittent medication method with the reduced dose was applied, that is, taking apatinib 250-mg/d for 3 days and stopping for 2 days. After that, thrombocytopenia did not recur and the patient kept in stable condition.
  • 滥用误用
    Wu Yurong
    . 2007, 9(5): 339-340.
    A 15-year-old girl received IV dexamethasone(dosage not stated)for a fever(T 38.4 ℃)2 days after the occurrence of eruption.The next day,her skin rash aggravated and she developed hemorrhagic herpes accompanied by lumbago.The third day,she developed headache,nausea,and vomiting.Laboratory tests revealed the results as follows:WBC 19.65×109/L,RBC 3.65×1012/L,Hb 123 g/L,PLT 46×109/L,ALT 4 247 U/L,AST 4 719 U/L,LDH 1 209 U/L,and CK 612 U/L.After hospitalization,the patient presented with trance,tenderness over the abdomen,percussion pain in the both renal region.Her heart rate was 130 beats/min and blood pressure was 86/60 mmHg.Laboratory tests showed the following values:WBC 17.4×109/L,L 0.32,RBC 2.56×1012/L,Hb 93 g/L,PLT 27×109/L,urine occult blood(+),PO2 11.76 mmHg,and PCO2 2.5 mmHg.She had a history of contacting closely with the patient with varicella within 2 weeks.She was diagnosed as varicella,varicella encephalitis,multiorgan injury,infective shock,disseminated intravascular coagulation,and metabolic acidosis.The patient was given treatments with elevation of blood pressure,blood volume expansion,hemostasis,correction of acidosis,anti-infection.But she developed haematemesis,continuous bleeding from oral and nasal cavity,anuria,blood pressure reduction,and deep coma.She died 12 hours after hospitalization.
  • Jin Xing, Zhou Hua, Yu Zhangfeng
    Adverse Drug Reactions Journal. 2023, 25(3): 178-180. https://doi.org/10.3760/cma.j.cn114015-20220610-00505
    A 44-year-old male patient received sodium valproate tablets 0.2 g and carbamazepine 0.1 g twice daily orally for a long time due to epilepsy, rabeprazole sodium enteric-coated tablets 10-mg once daily orally for a long time due to duodenal ulcer. Due to poor efficacy, the antiepileptic drug was adjusted to sodium valproate sustained-release tablets 0.5 g orally twice daily in combination with levetiracetam 0.25 g orally twice daily, and paroxetine 20-mg orally once daily because of depression was given at the same time. After about 3 months of treatments, the patient repeatedly suffered from limb convulsions, and the laboratory test showed serum sodium 128-mmol/L. Oral and intravenous sodium supplementation were given for 16 days, but his blood sodium level was still less than 130-mmol/L. It was considered that the hyponatremia of the patient might be caused by drugs. After stopping paroxetine, the patient′s blood sodium concentration returned to 140-mmol/L 2 days later.
  • Chen Can, Chen Zhangzhang, Li Jing, Li Yanli, Li Xiaoye, Xu Qing, Li Xiaoyu, Lyu Qianzhou
    Adverse Drug Reactions Journal. 2022, 24(7): 353-359. https://doi.org/10.3760/cma.j.cn114015-20211202-01215
    Objective To explore the effect of clinical pharmacist-led safety management in clinical use of oral anticoagulants (OACs) on reducing medication errors (MEs) in hospitalized patients. Methods On July 1st, 2018, the working group on the safe application of anticoagulants, composing clinical pharmacists majoring in cardiology, cardiac surgery, neurology, geriatrics, orthopedics, respiratory, and vascular surgery, was established at the Department of Pharmacy, Zhongshan Hospital Affiliated to Fudan University to comprehensively strengthen the intervention in the OACs prescription MEs for inpatients in relevant departments. Two percent of patients who were treated with OACs and aged ≥18 years during hospitalization in the above departments were screened using stratified sampling method and divided into pre-intervention group (patients were admitted in January 2017 to June 2018) and post-intervention group (patients were admitted in July 2018 to December 2019). The medical records of patients in the 2 groups were collected using the hospital information system, and the occurrence of MEs in the prescription link was analyzed retrospectively. Results A total of 296 and 325 patients were included in the pre- and post-intervention groups respectively. There was no significant difference in terms of gender, age, inpatient department, anticoagulation indications, OACs class, comorbidities, and concomitant medications in patients between the 2 groups (all P>0.05). The most frequently used anticoagulants in the 2 groups both were warfarin, which was used in 75.3% (223/296) and 71.4% (232/325) of the patients respectively, and followed by rivaroxaban, which was used in 17.6% (52/296) and 23.7% (77/325) of the patients respectively. Among the 296 patients in the pre-intervention group, 75 times of MEs related to OACs were found in the prescription for 72 (24.3%) patients, of which 30, 39, 5, and 1 times of MEs graded C, D, E, and F in severity respectively, and the incidence of severe MEs (grade E and F) was 2.0% (6/296). Among the 325 patients in the post-intervention group, 49 times of MEs related to OACs were found in the prescription for 47 (14.5%) patients, of which 22 times of MEs were grade C and 27 were grade D, and no severe ME was found. The incidences of overall MEs and severe MEs in the post-intervention group were significantly lower than those in the pre- intervention group (all P<0.05). Four types of MEs were all found in the prescription of OACs in the 2 groups, inclu- ding choosing inappropriate drugs (all presented as not selecting drugs based on drug interactions), wrong drug dose, drug omission, and wrong dosing frequency. The incidences of the above 4 types of MEs were 11.5% (34/296), 8.1% (24/296), 4.7% (14/296), and 0.7% (2/296) in the pre-intervention group, and 5.5% (18/325), 6.2% (20/325), 3.1% (10/325), and 0.3% (1/325) in the post-intervention group, respectively. The incidence of choosing inappropriate drugs in the post-intervention group was significantly lower than that in the pre-intervention group [5.5% (18/325) vs. 11.5% (34/296), χ2=7.143, P=0.008]. Conclusion The safety management of OACs in clinical application led by clinical pharmacists can reduce the MEs in prescriptions of OACs for inpatients, especially the incidence of severe MEs and choosing inappropriate drugs, and improve the safety of OACs in application.
  • Zhao Zinan, Jin Pengfei, Zhao Fei, Zheng Yujing, Hu Xin, Zhang Yatong
    Adverse Drug Reactions Journal. 2022, 24(2): 61-66. https://doi.org/10.3760/cma.j.cn114015-20210826-00937
    Objective To establish active surveillance programs of lung injury associated with programmed cell death 1 receptor (PD-1)/programmed cell death ligand 1(PD-L1) inhibitors. Methods The US FDA Adverse Event Reporting System was searched and case reports on PD-1/PD-L1 inhibitor-related lung injury from 2016 to 2020 were collected. Relevant guidelines/consensus and the labels of 5 PD-1/PD-L1 inhibitors (sintilimab, camrelizumab, nivolumab, tislelizumab, and atezolizumab) that were available in Beijing hospital were collected. Through comprehensive analysis on above information, a PD-1/PD-L1 inhibitor-associated lung injury risk signal set was formed. Using the user-defined function of adverse drug reaction intelligent monitoring system in the hospital information system (HIS) and technologies of trigger tool and text information extraction, the risk signals were matched to the 4 data modules (text module, doctor′s order module, test module, and examination module) in the intelligent monitoring system and the initial surveillance program was established. The initial program were optimized after 1 month of trial operation and an active surveillance program formed finally which matched the HIS electronic medical record system and conformed to the doctors′ habits in electronic medical records writing in our hospital. The electronic cases of all patients who treated with PD-1/PD-L1 inhibitors during hospitalization in our hospital from October 1, 2020 to August 6, 2021 were collected. The feasibility and accuracy were validated by applying this program to explore lung injury risk signals. Results The initial program involved 3 modules in the intelligent monitoring system other than the test module. The text module identified 6 trigger keywords/phrases and 18 exclusion keywords/phrases, the physician order module identified trigger drugs (5 PD-1/PD-L1 inhibitors and 3 kinds/classes of drugs for treating or alleviating lung injury), and the examination module identified that chest CT examination was performed and any one of the 6 trigger keywords/phrases appeared in the CT examination report. If the risk signals in the 3 modules was probed simultaneously in one patient, it was an early warning case. After a trial run of 1 month, 5 exclusion keywords/phrases were added, a class of drugs for treating or alleviating lung injury was deleted, and some modification was done in verbal statement. Electronic medical records of 303 inpatients within the set time was inspected using the surveillance program, and 41 early warning cases were detected. Through manual reviewing and causality evaluation, PD-1/PD-L1 inhibitor-related lung injury was conformed finally in 15 patients (5.0%), and the recognition accuracy of the program was 36.6% (15/41). Conclusions The surveillance program of PD-1/PD-L1 inhibitor-related lung injury was successfully established. The preliminary surveillance results showed that the program had good feasiblity and accuracy.
  • Wang Xin, Zan Qiang, Li Hui
    Adverse Drug Reactions Journal. 2021, 23(3): 156-157. https://doi.org/10.3760/cma.j.cn114015-20200929-01001
    A 50-year-old male patient was treated with adefovir dipivoxil 10-mg/d once daily for chronic hepatitis B. Seven years later, the patient developed multiple bone pains all over the body, which were gradually aggravated and restricted his movements. X-ray, CT, and magnetic resonance imaging examinations showed old fractures of the left 8th rib and the right 7th rib and fracture of the right femoral neck. Laboratory tests showed that serum creatinine was 111-μmol/L, serum phosphorus was 0.41-mmol/L, and alkaline phosphatase was 216-U/L. Bone mineral density examination showed osteoporosis in the 1st to 4th lumbar vertebrae, femoral necks, and total hipbones. Adefovir dipivoxil-induced hypophosphatemia was diagnosed. Adefovir dipivoxil was discontinued and replaced by entecavir, and oral phosphorus supplementation was given. After 2 months of treatments, the patient′s symptoms were improved. After 6 months of treatments, the bone pain basically disappeared and alkaline phosphatase, serum creatinine, and phosphorus returned to normal.
  • 综合报道
    . 2000, 2(3): 177-179.
    本文对药物不良反应中的性别差异问题作一简要介绍,并初步探讨引起这种差异的有关因素及其在临床的意义。
  • 学术研讨
    . 2005, 7(5): 326-329.
    急性感染性腹泻治疗主要包括补液和快速补充营养。而活菌制剂在其中的作用目前有两种观点,一是认为补充肠道正常菌群治疗感染性腹泻可以缩短病程,减轻症状。而另一观点认为,近年来从活菌制剂的药动学,药效学和随机应用安慰剂对照的临床试验研究提示,用活菌制剂进行额外的干预治疗并非必要,因此对活菌制剂在感染性腹泻的应用价值提出了质疑。但两种观点都提出益生元的概念,且认为活菌制剂与益生元制成合剂,即合生元是其发展方向。
  • 抗菌药应用
    . 2005, 7(5): 355-362.
  • 调查研究
    Wu Yuanshan;Zheng Qiku;Li Yueling;Bi Qili;Huang Zuojun
    . 2002, 4(6): 364-368.
    Objective: To investigate the drug-induced liver damage in recent years. Method: Literature was retrieved from CBMdisc 1990-2001. Results: Antituberculous agents, traditional Chinese medicines and immunosuppressants were the most common drugs responsible for liver damage(LD). The risk of LD might be increased in patients by concomitant administration of potentially hepatotox-ic drugs. In the cases of renal transplantation, immunosuppressants would result in acute liver failure, the major death cause of LD. Conclusion: Care should be taken for LD caused by the above drugs, with liver function monitoring in renal recipients in particular.
  • Xu Huiwei, Wu Haiwen, Xu Yingqing, Yu Haiying, Zhou Yan
    Adverse Drug Reactions Journal. 2020, 22(5): 323-325. https://doi.org/10.3760/cma.j.cn114015-20181206-01210
    A 66-year-old female patient received Gukang capsules and Jieguqili pills orally for 11 days for fracture. On day 6 after the drugs withdrawal, she developed weakness, anorexia, and yellow urine. Drugs above-mentioned were re-given and ibuprofen and codeine phosphate tablets were added. Five days later, her symptoms were aggravated. Laboratory tests showed alanine aminotransferase (ALT) 778-U/L, aspartate aminotransferase (AST) 782-U/L, alkaline phosphatase (ALP) 151-U/L, total bilirubin (TBil) 34.3-μmol/L, direct bilirubin (DBil) 24.0-μmol/L, and gamma-glutamyltransferase (γ-GT) 111-U/L. It was considered to be liver injury caused by Gukang capsules, Jieguqili pills, and ibuprofen and codeine phosphate tablets. All drugs above were withdrawn and the liver-protective and anti-jaundice treatments were given. After 21 days, laboratory tests showed ALT 24-U/L, AST 17-U/L, ALP 104-U/L, TBil 13.6-μmol/L, DBil 9.0-μmol/L, and γ-GT 52-U/L.
  • 安全用药
    Cao Jua;Su Taob;Li Xiaomeib
    . 2010, 12(5): 325-4.
    In recent years acute kidney injury(AKI) caused by antiinfective drugs is on an upward trend. Domestic data show that 39.0%54.0% of the cases of drugcaused AKI are related to anti-infective drugs, mainly aminoglycosides, β-lactams, glycopeptides, quinolones, etc. AKI usually occurs a few days or weeks after drug administration. The clinical manifestations include mainly oliguria or non-oliguric renal insufficiency. The pathologic appearance includes acute necrosis of renal tubules and acute interstitial nephritis. The risk factors for anti-infective drug-caused AKI include advanced age, renal insufficiency and combined use of anti-infective drugs with other medicines. If anti-infective drug-caused AKI occur, the drug should be withdrawn immediately and prednisone or renal dialysis given. The clinicians should pay attention to the rational drug use among the high-risk population, avoid high dosage and long-term use of the drug, and monitor the kidney function of patients so as to decrease the incidence of AKI and improve the prognosis.
  • 病例报告
    Hou Juana;Ma Jingtaob;Xu Fangb;Hu Yingb
    . 2008, 10(6): 0-0.
    A 60yearold woman with coronary heart disease received intraarterial iodixanol 50 ml prior to undergoing coronary angiography. One hour after surgery, the woman experienced dizziness, nausea, severe headache, and blurred vision. Her BP was 110/70 mmHg and her cranial CT scan was normal. She was given dexamethasone, fluid replacement and symptomatic therapy. Seven hours and a half later, her symptoms resolved completely.
  • 安全用药
    . 2006, 8(5): 355-358.
    利妥昔单抗是一种抗CD20的人鼠嵌合性单克隆抗体,能特异性地与跨膜抗原CD20结合,结合后启动介导B细胞溶解的免疫反应,诱导B细胞凋亡和提高瘤细胞对化疗的敏感性。1997年12月美国FDA批准上市,成为第一个用于治疗CD20+的B细胞非霍奇金淋巴瘤的单克隆抗体,单药有效率为40%~50%,联合CHOP方案化疗有效率达90%以上。主要不良反应包括输液反应、胃肠道反应、感染、心血管反应、血液学毒性、肝损伤等,程度一般为Ⅰ~Ⅱ级,大都见于首次用药,随着多次用药,症状会逐渐减轻或消失,属非剂量限制性毒性,无骨髓抑制,多数患者耐受良好。
  • Tong Zhiqiang, Xing Yue, Jiang Shuai, Li Xiang, Dong Mei
    Adverse Drug Reactions Journal. 2021, 23(7): 352-356. https://doi.org/10.3760/cma.j.cn114015-20210709-00772
    Patients with cancer are at high risk for coronavirus disease 2019 (COVID-19). Institutions for disease control and prevention and cancer-related learned societies in many countries recommend prioritizing cancer patients for COVID-19 vaccines. All the COVID-19 vaccines currently approved for emergency use, including inactivated vaccines, mRNA vaccines, recombinant adenovirus vector-based vaccines, and recombinant protein subunit vaccines, can be applied in cancer patients. Cancer patients with stable disease can be vaccinated against COVID-19 at any time, while patients with advanced-stage cancer or undergoing anticancer therapy should decide on the timing of vaccination according to the specific situation such as treatment methods and cancer type, etc.. The benefits of COVID-19 vaccination in cancer patients may outweigh the risks, but the immune response rate may be lower in cancer patients, especially in patients with haematological malignancies, than in healthy individuals.
  • 学术研讨
    . 2006, 8(5): 326-329.
    对于是否需要补钙、如何补钙以及其安全性如何尚存在较大争议。2006年2月16日美国《新英格兰医学杂志》刊登了“补钙加维生素D与骨折危险”的研究报告,对如何补钙问题又给人们带来新的困扰。作者根据国内外资料和个人的研究,对补钙争议的相关问题提出一些看法,旨在探讨如何安全有效地补钙。
  • . 2016, 18(3): 161.
  • 论著
    Wang Ning;Chen Haiping*
    . 2007, 9(6): 384-387.
    Objective:To discuss clinical features and risk factors of statin-induced myopathy.Methods:The clinical symptoms and the changes in serum creatine kinase(CK) concentrations and renal function in 7 patients with statin-induced myopathy from January 2004 to December 2006 were investigated retrospectively.Results:Seven male patients aged 16~71 [average age(49±19) years] were included,and three of them were over 60 years old.Of the 7 patients,3 patients were treated with a statin alone as follows:atorvastatin 10 mg daily;atorvastatin 20 mg daily;simvastatin 20 mg daily.And 4 patients received combination therapy with a statin and fenofibrate or vitamin E nicotinate as follows:atorvastatin 10 mg daily plus fenofibrate 200 mg daily;pravastatin 20 mg daily plus fenofibrate 200 mg daily;simvastatin 20 mg daily plus vitamin E nicotinate 0.2 g three times daily;atorvastatin 20 mg daily plus vitamin E nicotinate 0.2 g three times daily.The time of onset of markedly elevated serum CK concentrations(377~910 U/L)) in the 7 patients was 5 days to 26 months after treatment with statins.In addition,muscle pain occurred in 1 patient,muscle weakness occurred in 4 patients,and elevated SCr and BUN levels occurred in 1 patient,which were 340.6 μmol/L and 50.1 mmol/L respectively.Conclusion:Statins can cause myopathy,and its clinical presentations are muscle pain,muscle weakness,and elevated serum CK concentrations.Advanced age and combination therapy with a statin and fenofibrate or vitamin E nicotinate may increase the risk of myopathy.
  • Zhang Shilin, Li Zhengrong, Lai Xiangyang
    Adverse Drug Reactions Journal. 2022, 24(4): 216-217. https://doi.org/10.3760/cma.j.cn114015-20210601-00625
    A 39-year-old male patient underwent coronary angiography due to acute extensive anterior myocardial infarction and a stent was placed in the anterior descending branch. After the operation, the patient received dual antiplatelet therapy with aspirin enteric coated tablets 100-mg orally once daily and ticagrelor 90-mg orally twice daily. Four days later, the patient stopped ticagrelor by himself. Three days after drug withdrawal, he developed chest tightness and chest pain. The coronary angiography showed stent thrombosis, which was considered to be related to discontinuation of ticagrelor. Thrombus aspiration was performed and coronary angiography showed no stenosis and unobstructed blood flow. Dual antiplatelet therapy was continued after operation. At a 2-month follow-up, the patient did not have chest tightness, chest pain, or other symptoms after taking medicine regularly according to the doctor′s advice.
  • Zheng Feilang
    Adverse Drug Reactions Journal. 2023, 25(2): 120-122. https://doi.org/10.3760/cma.j.cn114015-20220507-00399
    A 75-year-old male patient with lung cancer received intravenous infusion of sintilimab 200-mg on day 1, 21 days as one cycle. Three days after the 5th cycles of treatment, the patient developed edema of lower limbs and yellowish skin on whole body. Laboratory tests showed alanine aminotransferase (ALT) 914-U/L, aspartate aminotransferase (AST) 622-U/L, alkaline phosphatase (ALP) 385-U/L, total bilirubin (TBil) 152.6-μmo1/L, direct bilirubin (DBil) 87.9-μmol/L, indirect bilirubin (IBil) 64.7-μmol/L and total bile acid (TBA) 25.8-μmol/L. The liver injury caused by other reasons was excluded by laboratory and auxiliary examination, and it was diagnosed as drug-induced liver injury, which was considered to be related to sintilimab. Drugs such as reduced glutathione, compound glycyrrhizin, ademetio- nine, polyene phosphatidylcholine, magnesium isoglycyrrhizinate, and ursodeoxycholic acid successively were given. The patient′s edema of lower limbs and yellowish skin gradually subsided. After 25 days of treatments, laboratory tests showed ALT 33-U/L, AST 33-U/L, ALP 92-U/L, TBil 18.2-μmol/L, DBil 5.2-μmol/L, IBil 13.0-μmol/L, and TBA 7.4-μmol/L.
  • Zhang Chuan, Zhang Li
    Adverse Drug Reactions Journal. 2021, 23(9): 449-452. https://doi.org/10.3760/cma.j.cn114015-20210817-00899
  • . 2017, 19(1): 3-5.
  • Feng Xin, Gai Di
    . 2017, 19(5): 321.
  • 论著
    Luo Leiming①;Li yanhan②;Gu Jie②;Liu Li①;Yang Xue①;Zhu Bing①;Zeng Qiang①;Chen Minzhi①;Wu Hongmei①;Ye ping①
    . 2007, 9(1): 14-17.
    Objective: To study on the effects of erythropoietin on risk of thrombus in patients with chronic heart failure. Methods: Forty-three patients with chronic heart failure and mild anemia were divided randomizely into two groups: erythropoietin (EPO) group (22 cases) and control group (21 cases). The patients in the EPO group were administered with polysaccharide-iron complex 150 mg two times daily plus erythropoietin 10 000~15 000 U weekly. The patients in the control group were administered with polysaceharide-iron complex 150 mg two times daily. The target haemoglobin concentration was 135 g/L, and the duration of therapy was 3 months. The plasma levels of four thrombus molecular markers including thrombin-antithrombin Ⅲ complex (TAT), prothrombin fragments 1 and 2 (F1+2), D-dimer (D-D), and plasmin-antiplasmin complex (PAP) were measured with ELISA method after 3 months treatment. Results: There were not significant differences in four thrombus molecular markers before and after treatment in the EPO group, and after treatment between the EPO group and control group (all P>0.05). Conclusion:The potential risk of thrombus is not obviously increased in patrents with chronic heart failure treated with erythroietin 10 000~15 000 U weekly.
  • 病例报告
    Zhang Chaoa;Xie Qianb
    . 2008, 10(6): 0-0.
    Two male patients developed acute renal failure after receiving an IV infusion of andrographolide injection.The first patient, a 29-year-old patient, received an IV infusion of andrographolide 0.5 g for a fever. He developed lumbago after the infusion. His SCr was 142 μmol/L in the evening at that day. The next day, he was hospitalized and his SCr was 219 μmol/L. On day 2 of hospitalization, the patient’s SCr was 332 μmol/L. Acute renal failure was diagnosed. Fluid replacement and symptomatic therapy were given. Three days later, his SCr decreased to 244 μmol/L. On day 7 of hospitalisation, his SCr decreased to 149 μmol/L. After 9 days of hospilisation, the patient was discharged, and his lumbago disappeared. A followup 10 days after discharge, his renal function normalized.The second patient, a 25-year-old man, received an IV infusion of andrographolide 0.25 g and oral azithromycin 0.25 g for a cold. After about 4 hours of the infusion, the patient developed lumbago.The next day, his SCr was 189.7 μmol/L and his BUN was 889 μmol/L. All drugs were discontinued. On day 3, his lumbago persisted, his SCr was 214 μmol/L and his BUN was 8.8 μmol/L. After receiving supportive therapy, his SCr decreased to 138 μmol/L and his BUN decreased to 6.4 μmol/L. A followup one week after discharge, his renal function normalized.
  • Zhang Lingli
    . 2016, 18(2): 81.
  • Adverse Drug Reactions Journal. 2020, 22(3): 142-146. https://doi.org/10.3760/cma.j.cn114015-20200310-00179
    国家卫生健康委员会和国家中医药管理局2020年2月18日发布的《新型冠状病毒肺炎诊疗方案(试行第六版)》将磷酸氯喹作为抗病毒试用药物之一,其后又于同月26日发布了《关于调整试用磷酸氯喹治疗新冠肺炎用法用量的通知》,2020年3月3日发布的《新型冠状病毒肺炎诊疗方案(试行第七版)》对磷酸氯喹给药方案进行了修订。磷酸氯喹半衰期长、全身分布广泛,易在体内蓄积,且不良反应与剂量相关。本文结合磷酸氯喹的药代动力学特点对给药方案进行了安全性分析,供临床医师和药师在诊治新型冠状病毒肺炎患者时参考,以降低发生不良反应的风险。
  • Yao Genqin, Song Jun, Cui Zhihong
    Adverse Drug Reactions Journal. 2021, 23(12): 653-654. https://doi.org/10.3760/cma.j.cn114015-20210226-00236
    An 86-year-old male patient with cerebral infarction was treated with dual antiplatelet therapy consisting of aspirin enteric-coated tablets 100-mg orally once daily and clopidogrel 75-mg orally once daily after thrombolytic therapy. The concomitant drugs included atorvastatin calcium, fibrinogenase for injection, butylphthalide and sodium chloride injection, pantoprazole sodium for injection, and cefoperazone sodium and sulbactam sodium for injection. After 26 days of dual antiplatelet therapy, the neutrophil count had an obvious decrease from 2.44×109/L before treatment to 0.49×109/L. Cefoperazone sodium and sulbactam sodium for injection and aspirin enteric-coated tablets were stopped successively, leucogen, Qijiao Shengbai capsules (芪胶升白胶囊), and recombinant human granulocyte colony stimulating factor injection were given, but the neutrophil count continued to decline, with the lowest value of 0.03×109/L. The correlation between neutropenia and clopidogrel was considered. Then clopidogrel was stopped and 3 days later, the patient′s neutrophils returned to normal.
  • Peng Wenxing, Shi Xiujin, Xu Xiaoyu, Zhou Yang, Zhang Yi, Lin Yang
    Adverse Drug Reactions Journal. 2020, 22(8): 460-465. https://doi.org/10.3760/cma.j.cn114015-20191021-00838
    Objective To explore the occurrence and risk factors of bleeding events in acute coronary syndromes (ACS) patients treated with ticagrelor combined with aspirin. Methods The study subjects were selected from ACS patients who were admitted to Beijing Anzhen Hospital, Capital Medical University from January to December 2017 and treated with ticagrelor and aspirin (aspirin 100-mg/d, ticagrelor 180-mg/d). Medical records of the patients who met the inclusion criteria(at age>18 years, with medication duration ≥ 1 year, and with complete follow-up records) were collected and retrospectively analyzed. The patients were divided into bleeding group and non-bleeding group according to whether there were bleeding events within 1 year. Baseline clinical characteristics such as gender, age, type of ACS, comorbidities, combined drugs, history of percutaneous coronary intervention, routine blood parameters, liver and kidney function, and etc. in patients between 2 groups were compared. The risk factors of bleeding events were analyzed using logistic regression method and the odds ratio (OR) and its 95% confidence interval (CI) were calculated. Results A total of 180 patients were entered in the analysis, including 135 males and 58 females, aged (57±10) years, with the range of 31 to 81 years. There were 39 patients in the bleeding group and 141 patients in the non-bleeding group, and the incidence of bleeding events was 21.7%. None of the differences in gender distribution, age, comorbidities, history of percutaneous coronary intervention or combined drugs in patients between the 2 groups were statistically significant (all P>0.05). The platelet count of patients in the bleeding group was significantly lower than that in the non-bleeding group [(197±49) ×109/L vs. (220±60) ×109/L, t=2.254, P=0.025]. The shortest time from medication to the onset of bleeding of the 39 patients in the bleeding group was 14 days and the longest one was 12 months. The cumulative incidences of bleeding events at 3, 6, and 12 months of medication were 12.2% (22/180), 18.3% (33/180), and 21.7% (39/180), respectively. All bleeding events were minor bleeding, and the skin mucous ecchymosis had the highest incidence, which was 15.0% (27/180), followed by gingival bleeding or nosebleed, which was 7.2% (13/180). The incidence of fundus hemorrhage was 1.7% (3/180) and incidences of gastrointestinal bleeding and hematuria were both 0.6% (1/180). Multivariate logistic regression analysis showed that low platelet count was an independent risk factor for bleeding events [OR=0.991, 95%CI: 0.984-0.999, P=0.020]. Conclusions ACS patients have a relative high risk of bleeding events when treated with ticagrelor combined with aspirin, but most of them were minor. For ACS patients with low platelet counts, this anti- platelet regimen should be used with caution and drug monitoring should be done in the whole course.
  • Fu Yuechen, Song Zhihui, Dong Rui, Zhang Chao
    Adverse Drug Reactions Journal. 2021, 23(6): 298-303. https://doi.org/10.3760/cma.j.cn114015-20200721-00798
    Objective To investigate the effect of telephone follow-up-based pharmaceutical care on medication compliance and safety in discharged patients with type 2 diabetes mellitus. Methods Type 2 diabetes mellitus patients, who were discharged from Beijing Tongren Hospital, Capital Medical University from January 2019 to December 2019 and with hemoglobin A1c (HbA1c) <9% during hospitalization were enrolled. Patients were divided into routine follow-up group and telephone follow-up group according to the post-discharge follow-up method. Patients in the routine follow-up group received routine pharmaceutical care and were followed up for 6 months after discharge, including outpatient follow-up once every 3 months and HbA1c test at the 6th month. On this basis, patients in the telephone follow-up group received pharmaceutical care by clinical pharmacists using telephone follow-up method, which was performed once every 2 weeks for the first 3 months after discharge and once a month for the next 3 months. The clinical pharmacists established follow-up registration files for patients in the 2 groups to record the condition of the patients on discharge and results of each follow-up. Scores of the "Diabetes Self-Management Scale (Chinese version)" score (DSMQ score, with a total score of 48 points, the higher the score, the better the self-management ability of the patient), "Chinese Version Morisky Medication Adherence Scale-8" score (Morisky score, with a total score of 8 points, regarding 6 to 8 points as good compliance), and blood glucose control results (evaluation index is HbA1c level, HbA1c <7.0% was used as the standard to calculate the compliance rate) 6 months after discharge and the incidences of adverse drug events during the follow-up period in patients between the 2 groups were compared. Results A total of 95 patients were enrolled in the analysis, including 48 in the telephone follow-up group and 47 in the routine follow-up group. Differences in gender and age distribution, body mass index, DSMQ score, and HbA1c level and compliance rate on discharge in patients in the 2 groups were not statistically significant (all P>0.05). Six months after discharge, both the DSMQ score and Morishy score in the telephone follow-up group were higher than those in the routine follow-up group [(38.1±4.4) vs.(34.3±4.1) points, P<0.001; (6.5±1.2) vs.(5.7±1.0) points, P<0.001]; the proportion of patients with good medication compliance in the telephone follow-up group were higher than those in the routine follow-up group [81.3%(39/48) vs. 40.4%(19/47), P=0.031]; the HbA1c level was lower and the HbA1c compliance rate was higher in the telephone follow-up group than those in the routine follow-up group[(6.2±1.2)% vs. (6.7±1.4)%, P=0.042; 72.9% vs. 51.1%, P=0.028]; the incidence of adverse drug events in the telephone follow-up group was lower than that in the routine follow-up group [6.2% (3/48) vs. 25.5% (12/47), P=0.010]. Adverse drug events occurred in patients mainly included hypoglycemia, fatty induration or infection at the insulin injection site, and gastrointestinal reactions. Conclusion Telephone follow-up-based pharmaceutical care can effectively improve the self-management ability of patients with type 2 diabetes after discharge, help patients maintain good medication compliance, thereby improving the blood glucose control effects and to a certain extent reducing the occurrence of adverse drug events.
  • Peng Huaidong, Feng Xia, Wang Ruolun
    . 2017, 19(1): 57-58.
    A 50-year-old woman received surgical treatment because of severe gastrointestinal perforation and acute diffuse peritonitis. She received subcutaneous injection of recombinant human growth hormone 5 U once daily to promote the surgical wound healing. The patient′s serum calcium was 2.51 mmol/L before treatment. On day 3 of drug administration, the serum calcium was 2.62 mmol/L. On day 13, the serum calcium was 3.17 mmol/L. Recombinant human growth hormone was stopped. One week later, the serum calcium was decreased to 2.55 mmol/L.
  • 病例报告
    Wang Chunyun
    . 2008, 10(6): 386-1.
    A 23-year-old woman with depression successively received fluoxetine, venlafaxine, amfebutamone and amantadine without adverse reactions. Subsequently duloxetine 60 mg was added to the regimen of amfebutamone 225 mg/d and amantadine 0.2 g/d, which was given in the morning. Two to three days later, the woman presented with redness and swelling on the dorsum of her feet without pain; her renal function and rheumatoid factor examinations were normal. Treatment with IV cefalexin was ineffective. Duloxetine was withdrawn after fourteen days of administration. Amfebutamone and amantadine were continued. The redness and swelling on the dorsum of her feet subsided 3-5 days later.
  • 综述
    . 1999, 1(2): 69-79.
    本文回顾了自60年代开展药物不良反应监测研究以来,传统上所采用的监测方法,包括自发报告、医院集中监测和处方事件监测各自的优缺点及在不良反应研究领域中的应用与地位;介绍了自70年代起在北美及欧洲建立的主要的大型自动记录数据库,目前在药物不良反应因果关系评价及药物流行病学研究中的应用;以及计算机在药物不良反应监测、因果关系评价中的应用等,并对从单纯的药物不良反应研究发展到药物流行病学的研究前景进行了展望。
  • 安全用药
    . 2003, 5(2): 95-97.
  • Wang Hailian, Chen Lianzhen, Jin Yan
    . 2016, 18(3): 175.
    ObjectiveTo understand the medication situation of Alzheimer′s disease(AD) of six cities in ChinaMethodsThe data were from 50 hospitals of six cities (including Beijing, Tianjin, Shanghai, Guangzhou, Chengdu and Hangzhou) in China which involved in the Hospital Prescription Analysis Cooperative Project. Prescriptions from Department of Outpatient and Emergency, doctor′s orders of inpatients in 40 days in each hospital in each year from 2012 to 2014 were selected randomly. The information of medication use about AD was extracted and analyzed using software of Visual FoxPro 8.0 and SPSS 22.0.ResultsThere were 59 891 AD patients in six cities. The patients′ prevalence peak was in 75 to 89 years, accounted for 66.9% of the total cases of AD patients (40 096 patients). Application of cholinesterase inhibitors (ChEI) and N-methyl-D-aspartate (NMDA) receptor antagonist accounted for 46.5% of the total cases of AD patients (27 827/59 891), behavioral and psychological symptoms of dementia (BPSD) accounted for 26.4% (15 811/59 891), neural nutrition agent accounted for 15.1% (9 043/59 891), prevention of AD accounted for 11.7% (7 007/59 891). There were no significant differences in constituent ratios of ChEI use alone, NMDA receptor antagonist use alone, or ChEI combined with NMDA receptor antagonist treatment in AD patients in the 3 years (P>0.05). The compound annual growth rate was 69.6% of ChEI combined with NMDA receptor antagonist treatment. The top 3 drugs in AD patients were donepezil (14 254 patients), memantine (12 278 patients), and olanzapine (4 612 patients). Total amount of AD patients′ prescriptions was 20.124 million yuan, of the top 15 drugs according to the cost for AD treatment, the cost of first-line therapy was 9.129 million yuan (45.4%), the cost of BPSD was 1.538 million yuan(7.6%), the cost of neural nutrition agent was 1.278 million yuan (6.4%), and the cost of prevention of AD was 0.433 million yuan (2.2%).ConclusionsChinese doctors in six cities could follow European and Chinese AD treatment guidelines and implement multi-target drug combination regimen for AD patients. The use of drugs in this AD patients was basically reasonable. But there were some problems in which doctors prescribed ineffective drugs, leading to heavy economic burden in AD patients.
  • Geng Kuikui, Wu Shuhua, Liu Sheng, Shen Aizong, Hou Huan, Li Yuanya
    . 2015, 17(5): 348.
    ObjectiveTo construct the active monitoring system for adverse drug reactions based on the trigger technology and explore its application value.MethodsBased on the DTHealth system and electronic medical records system, using the Brower/Server architecture, DHCMedBase2.0.doc, Ext 3.1-API Documentation technology to design the trigger of the data definition language. The monitoring group selected the adverse drug reactions which can be used to reflect with the laboratory information, 12 triggers were chosen after communicating with the clinical medical staff, the related procedures were embedded in the hospital information system, accordingly, the active monitoring system of adverse drug reaction based on the trigger technology were constructed. By the three pharmacists the full-time work, the monitoring work within 23 wards of the hospital about 800 patients were finished through the triggers of adverse drug reactions monitor, and the suspected adverse drug reactions were filtered, evaluated and reported.ResultsThe active monitoring system of adverse drug reactions based on the trigger technology started operation in January 1st, 2014, and run until the June 30th, 2014, 561 positive patients were monitored by the triggers, and 71 adverse drug reactions which involved 28 kinds of drugs were identified, the total positive rate was 12.7%. The laboratory index of 21 patients were found to have a marked abnormality but not beyond the normal range, among them the 12 patients had to change the treatment to avoid the possible adverse drug reactions. ConclusionThe application of the trigger technology successfully constructed the active monitoring system of adverse drug reactions, which can improve efficiency of the active monitoring for adverse drug reactions, at the same time, realize the early warning function.
  • Zhao Kanglu, Guo Qiufang, Ye Weijiang
    . 2015, 17(6): 403-407.
    ObjectiveTo explore the effect of combination of telbivudine (LdT) and adefovir dipivoxil (ADV) on renal function in patients with chronic hepatitis B (CHB).MethodsThe CHB patients with renal injury due to lamivudine (LAM) resistance and combination with ADV, who visited in First Affiliated Hospital of Zhejiang Chinese Medical University were enrolled into this study. The randomized controlled trial was performed in this study. The patients were divided into two groups by table of random number: the LAM+ADV group (original treatment was continued) and the LdT+ADV group (LAM was replaced with LdT). The levels of HBV DNA, alanine aminotransferase (ALT), serum creatinine (Scr), estimated glomerular filtration rate (eGFR), urinary beta 2-microspheres (Uβ2-MG), and serum creatine kinase (sCK) were compared between the 2 groups at baseline, 24 and 48 weeks of treatments.ResultsA total of 79 patients were enrolled into the study. There were 41 patients in the LAM+ADV group and 38 in the LdT+ADV group. The differences of sex distribution, age, body weight and the basal level between the 2 groups were not statistically significant (all P>0.05). There were no HBV DNA breakthrough in patients during 48 weeks of treatment in both groups. The differences of ALT levels at different time points in patients in the 2 groups were not statistically significant (all P>0.05). In the LAM+ADV group, the Scr levels at 24 and 48 weeks of treatment were higher than those at baseline [(117±11), (122±12) μmol/L vs. (113±12) μmol/L]. The difference between the baseline and 48 weeks of treatment was statistically significant (P<0.05). The levels of Scr in the LdT+ADV group at 24 and 48 weeks of treatment were lower than those at baseline [(104±10), (99±9) μmol/L vs. (109±10) μmol/L] (all P<0.05). The levels of eGFR in the LAM+ADV group at 24 and 48 weeks of treatment were lower than those at baseline[(68.9±12.2), (66.1±7.6)ml·min-1·1.73 m-2 vs. (70.9±8.1) ml·min-1·1.73 m-2]. The difference between the baseline and 48 weeks of treatment was statistically significant (P<0.05). The levels of eGFR in the LdT+ADV group at 24 and 48 weeks of treatment were higher than those at baseline [(75.1±11.4), (79.6±31.1) ml·min-1·1.73 m-2 vs. (71.4±10.6) ml·min-1·1.73 m-2] (all P<0.05). The levels of Uβ2-MG in the group of LAM+ADV at 24 and 48 weeks of treatment were higher than those at baseline[4 611(23 920, 740), 4 719 (24 109, 967) μg/L vs. 4 601(23 807, 611) μg/L]. The difference between the baseline and 48 weeks of treatment was statistically significant (P<0.05). The levels of Uβ2- MG in the LdT+ADV group at 24 and 48 weeks of treatment were lower than those at baseline [3 251(12 890, 220), 1 950 (10 119, 73) μg/L vs. 4 109 (24 703, 633) μg/L]. The difference between the baseline and 48 weeks of treatment was statistically significant (P<0.05). The difference of sCK levels between the baseline and 24 and 48 weeks of treatments[(99±31), (99±36), (96±37)]were not statistically significant (all P>0.05). The sCK levels in the LdT+ADV group at 24 and 48 weeks of treatments were higher than those at baseline[(107±38), (130±56) U/L vs. (97±31) U/L]. The difference between the baseline and 48 weeks of treatment was statistically significant (P<0.05). The differences of Scr, eGFR, Uβ2-MG, and sCK levels at baseline and 48 weeks of treatment in the 2 groups were statistically significant (all P<0.05).ConclusionsThe therapeutic regimen of telbivudine combination with adefovir dipivoxil can improve the renal function in patients with CHB. The change of sCK level should be monitor closely during the treatment.
  • 专题讲座
    . 2003, 5(4): 251-255.
  • Fei Xianshu, Guo Jing, Li Xueqi, Chen Fei, Lin Feishen
    Adverse Drug Reactions Journal. 2021, 23(12): 655-657. https://doi.org/10.3760/cma.j.cn114015-20210705-00748
    A 72-year-old male patient with secondary pulmonary tuberculosis developed skin erythema and pruritus of both lower limbs after 10 months of antituberculosis treatment with isoniazid, rifampin, ethambutol, and pyrazinamide, followed by blisters and bullae, and the skin lesions gradually spread to his whole body. The skin biopsy showed bullous pemphigoid, and the antibodies to bullous pemphigoid 180 detected by enzyme-linked immunosorbent assay was 156.8-U/ml. Considering that the patient′s bullous pemphigoid might be induced by rifampin, rifampin was discontinued and antitu- berculosis therapy was changed to isoniazid, ethambutol, pyrazinamide, and moxifloxacin. Prednisone acetate and symptomatic and supportive treatments were given at the same time. Two weeks later, the lesions were markedly improved, and the original erosive surface got scabs and basically healed. At 6 months of follow-up, the lesions recovered, and no new lesions or blisters occurred.
  • Luo Juan, Yuan Qi, Diao Changdong, Chen Xu, Fan Li, Shi Chen
    Adverse Drug Reactions Journal. 2021, 23(7): 361-364. https://doi.org/国家重点研发计划(2017YFC0909900
    Objective To compare the adverse reactions of oxycodone hydrochloride prolonged- release tablets and fentanyl transdermal system in the treatment of moderate and severe cancer pain. Methods The medical records of patients with moderate to severe cancer pain who used oxycodone hydrochloride prolonged-release tablets (oxycodone group) or fentanyl transdermal systems (fentanyl group) for more than 1 week during hospitalization in Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology from January 2018 to December 2019 were collected. The occurrence of adverse reactions after analgesic treatments were retrospectively analyzed. Results A total of 698 patients were enrolled in the analysis, including 535 in the oxycodone group and 163 in the fentanyl group. The incidence of adverse reactions in the oxycodone group was significantly higher than that in the fentanyl group [72.5% (388/535) vs. 51.5% (84/163), χ2=25.139, P<0.001]. The common adverse reactions (with incidence ≥5%) in the oxycodone group were constipation, nausea/vomiting, xerostomia, drowsiness, and dizziness, while those in the fentanyl group were constipation, nausea/vomiting, and dizziness. The incidence of constipation in the oxycodone group was significantly higher than that in the fentanyl group [60.9% (326/535) vs. 40.5% (66/163), χ2=21.209, P<0.001]. The differences in the incidence of other adverse reactions in the 2 groups were not statistically significant (all P>0.05). All adverse reactions were grade 1 or 2, which were improved after symptomatic treatments. No adverse reactions of grade 3 or more severe occurred.Conclusions Both oxycodone hydrochloride prolonged-release tablets and fentanyl transdermal system are safe during the treatment for moderate to severe cancer pain, with mild adverse reactions, which can be relieved by symptomatic treatments. Oxycodone hydrochloride prolonged-release tablets are more likely to cause constipation than fentanyl transdermal system.
  • Wu Jingling, Chen Xiaojun
    Adverse Drug Reactions Journal. 2022, 24(5): 264-265. https://doi.org/10.3760/cma.j.cn114015-20210826-00940
    A 50-year-old female patient with diabetes mellitus took metformin hydrochloride sustained release tablets (metformin) 0.5 g once daily orally by herself for 3 courses. The patient had vomiting or diarrhea after each medication. At the nearest treatment, the patient took the drug for 4 days and yellowish skin and sclera and fatigue appeared 3 days after drug withdrawal. Laboratory tests showed alanine aminotransferase (ALT) 422-U/L, aspartate aminotransferase (AST) 166-U/L, alkaline phosphatase (ALP) 276-U/L, γ-glutamyl transpeptidase (γ-GT) 369-U/L, total bilirubin (TBil) 383.0-μmol/L, and direct bilirubin (DBil) 269.9-μmol/L. After excluding the causes of viral hepatitis, autoimmune liver disease, and obstructive jaundice, liver injury caused by metformin was considered. Then metformin was stopped and treatments with magnesium isoglycyrrhizinate and Yinzhihuang granules (茵栀黄颗粒) were given. After 11 days of treat- ments, the above symptoms disappeared and the fatigue was alleviated. Laboratory tests showed ALT 225-U/L, AST 89-U/L, ALP 215-U/L, γ-GT 291-U/L, TBil 86.1-μmol/L, and DBil 44.6-μmol/L.
  • 相互作用
    . 2006, 8(3): 197-201.
    了解环孢素与其他药物之间可能发生的不良相互作用,以便合理利用有益的药物相互作用结果,供临床参考。通过检索Medline和其他医药学相关文献,对环孢素与其他药物间相互作用问题进行归纳和概述。环孢素与细胞色素P450酶系(CPY)中CYP3A4酶的多种抑制剂或诱导剂之间存在明显的相互作用,临床在联合应用时应注意监测环孢素的全血浓度,防止中毒或造成抗排异失败。
  • 调查研究
    Shi Huiqing;Zhang Lina;Zhong Yi
    . 2005, 7(2): 103-105.
    Objective: To investigate the factors of adverse reactions induced by fat emulsion injection. Methods: 25 reports of adverse raactions due to fat emulsion injection at our hospital in 2003 were retrospectively analysed. Results: Fever was the main clinical manifestation. The reactions were related to age of patients and concentration of the drug but not related to gender of patients. Conclusion: Health professionals should pay attention to the use of fat emulsion so as to reduce the occurrence of adverse effects.
  • Pan Wen, Ding Jing, Lyu Qianzhou, Li Xiaoyu
    Adverse Drug Reactions Journal. 2021, 23(3): 134-139. https://doi.org/10.3760/cma.j.cn114015-20200901-00930
    A variety of antiepileptic drugs are associated with hyponatremia, among which carbamazepine, oxcarbazepine, and eslicarbazepine are the most common, and other antiepileptic drugs involved include valproic acid, levetiracetam, lamotrigine, and lacosamide. Most patients with antiepileptic drug- related hyponatremia have mild symptoms, but severe acute or chronic persistent hyponatremia can lead to epilepsy, coma, and even death. The mechanism of hyponatremia induced by antiepileptic drugs is not fully clear and is currently thought to be likely related to abnormal antidiuretic hormone secretion. The risk factors of antiepileptic drug-related hyponatremia are older age, lower baseline serum sodium level, high drug exposure, and combination of multiple drugs. Attention should be paid to this kind of patients in clinic, and appropriate monitoring, prevention, and treatment should be carried out.
  • 调查研究
    Liu Yanping
    . 2000, 2(2): 94-97.
    The characteristics and distributions of ADRs of traditional Chinese medicines were reported in 111 cases. It was shown that there were no differences of ADRs of traditional Chinese medicines in the sex and age of patients. The time of the occurence of ADRs was longer, 35 cases (36.46%) being more than 24 hours. As to the types of reactions, there were 74 allergic reactions (66.67%), including 12 in anaphylactic shock (10.81%), 45 in skin (40.54%), 14 in drug fever (12.61%), and 3 in exfoliative dermatitis (2.70% ), 8 in digestive system (7.21%), 3 in urinary system (2.70%), 2 in cardiovascular system (1.80%), 1 in blood system (0.90%), 8 in nervous system (7.21%), 1 in respiratory system (0.90%), 14 other reactions (12.61%). The first five herb preparations of causing ADRs were arranged and discussed.
  • 论著
    Zhu Man;Wang Dongxiao;Guo Daihong;Huang Chunyan;Wang Yuqin;Yang Liping;Pei Fei;Wang Weilan;Tang Zhihui;Chen Chao;Ren Zhao
    . 2014, 16(4): 193-5.
    ObjectiveTo investigate the application of vancomycin in elderly inpatients.Methods
    The clinical data of elderly inpatients (≥60 years) treated with vancomycin from September 2012 to November 2013 in 5 hospitals including Peking University First Hospital, Beijing Hospital, Beijing Chao-Yang Hospital, Xuanwu Hospital of Capital Medical University, and Chinese PLA General Hospital were collected. All patients were divided into normal renal function group and renal insufficiency group. The application (dosage regimen, drug utilization situation, and therapeutic drug monitoring) and clinical efficacy of vancomycin and its effects on renal function in elderly patients were retrospectively analyzed. Drug utilization index (DUI) reflected the drug utilization situation. And parameters of renal function included serum creatinine (Scr), blood urea nitrogen (BUN) and creatinine clearance rate (Ccr).ResultsA total of 149 patients were enrolled in this study comprising 60 males and 89 females with age of 60-92(76±7) years. There were 87 cases in the normal renal function group and 62 cases in renal insufficiency group. The most widely used regimen of application of vancomycin was 0.50 g once every 12 hours in the normal renal function group (29/87, 33.33%) and 0.50 g once daily in the renal insufficiency group(30/62, 48.39%). The total dosage and time of using vancomycin were respectively 2 135.15 g and 1 919.5 d. And the DUI was 0.56. Among the 149 patients, 111 cases(74.50%) underwent blood concentration monitoring and there were no statistically significant differences in constituent ratio of undergoing blood concentration monitoring between the normal renal function group and the renal insufficiency group[70.11%(61/87) vs.80.65%(50/62),χ2=2.11,P=0.15]. In all patients undergoing blood concentration monitoring, trough concentration was detected and in 7 patients peak concentration was detected. The number of cases whose trough concentrations <10 mg/L was 30(49.18%) and 25 cases (50.00%) in the normal renal function group and the renal insufficiency group, respectively, and there were no statistically significant differences (χ2=2.16,P=0.54). The differences between before and after administration of vancomycin in Scr[(117±79) μmol/L vs. (119±81)μmol/L], BUN[(10.5±5.7) mmol/L vs. (12.5±8.0) mmol/L], and Ccr[(69±37) ml/min vs. (67±36) ml/min] in all the 149 patients were not statistically significant(all P>0.05). The differences between before and after administration of vancomycin in Scr[(59±16)μmol vs. (70±30)μmol/L, (189±110)μmol/L vs.(203±113)μmol/L], BUN[(7.4±3.5) mmol/L vs.(9.2±5.8) mmol/L, (14.8±6.5) mmol/L vs.(17.4±9.0) mmol/L], and Ccr[(107±29) ml/min vs.(96±26) ml/min, (44±30) ml/min vs.(33±16) ml/min] in the normal renal function group and the renal insufficiency group were not statistically significant (all P>0.05).ConclusionsThe use of vancomycin in elderly inpatients was relatively cautious. Dosage regimen should be adjusted timely according to the results of blood concentration and renal function tests and individualized administration should be adopted in order that the efficacy and safety could be improved.
  • 论著
    Sun Junan;Xia Zongling;Luo Can
    . 2014, 16(4): 209-4.
    ObjectiveTo explore the role of CRUSADE score for evaluating the risk of gastrointestinal bleeding due to antiplatelet agents.MethodsThe hospitalized patients with coronary heart disease and received antiplatelet therapy for more than 1 year before hospitalization in department of internal medicine in the Third People′s Hospital of Cixi, Zhejiang Province from September 2010 to September 2013 were enrolled into the study. The patients were divided into the gastrointestinal bleeding group and the non-gastrointestinal bleeding group according to whether gastrointestinal bleeding occurred due to antiplatelet agents. The CRUSADE score was evaluated in the 2 groups and the relationship between the CRUSADE score and gastrointestinal bleeding was analyzed.ResultsA total of 787 patients with coronary heart disease who received antiplatelet therapy more than 1 year were collected. Forty patients with gastrointestinal bleeding were enrolled into the gastrointestinal bleeding group. One hundred and sixty patients were enrolled into the non-gastrointestinal bleeding group by equidistant sampling method randomly. The gastrointestinal bleeding group comprised 31 male and 9 female with age from 45 to 88 (71±9) years. The non-gastrointestinal bleeding group comprised 100 male and 60 female with age from 36 to 89 (65±13) years. There was statistically significant difference in age between the 2 groups (P<0.05). The percentage of cases of receiving aspirin enteric-coated tablets, clopidogrel hydrogen sulfate tablets, and both the above-mentioned drugs in the gastrointestinal bleeding group and the non-gastrointestinal bleeding group were 55%(22/40),10%(4/40),35%(14/40) and 54%(86/160),7%(11/160), 39%(63/160), respectively. The difference was not statistically significant (P>0.05). The percentage of cases who had history of gastroin-testinal bleeding and peptic ulcer in the gastrointestinal bleeding group and the non-gastrointestinal bleeding group were 30.0%(12/40) and 11.9%(19/160), respectively. The difference was statistically significant (P<0.05). There were 27.5%(11/40) and 27.5%(11/40) cases with the results of CRUSADE score at high risk and very high risk in the gastrointestinal bleeding group, 8.1%(13/160) and 10.6%(17/160) cases in the non-gastrointestinal bleeding group, respectively. The difference was statistically significant (P<0.05) .ConclusionsCRUSADE score can help to evaluate the risk of gastrointestinal bleeding in patients with coronary heart disease who received antiplatelet therapy. It is suggested that the patients with coronary heart disease as well as the CRUSADE score of high risk and very high risk should receive the combination of antiplatelet agents and the proton pump inhibitor, in order to prevent or reduce the gastroin-testinal bleeding.
  • 安全用药
    . 2005, 7(5): 340-345.
    呼吸系统疾病是临床中常见的疾病之一,其中因药物导致的肺部疾病已逐渐引起人们的重视。药源性肺部疾病是药物不良反应的一种,具有涉及的药物范围广、疾病的种类多、发病机制复杂、起病方式差异大等特点。本文综述了可导致药物性肺炎、肺纤维化、哮喘、肺水肿、肺栓塞、肺出血、肺癌、肺动脉高压、肺血管炎等疾病的药物及可能的致病机制。提示药源性肺部疾病在其诊断、治疗、预后及其潜在的用药危险因素等方面均应引起医师足够的重视。呼吸系统疾病是临床中常见的疾病之一,其中因药物导致的肺部疾病已逐渐引起人们的重视。药源性肺部疾病是药物不良反应的一种,具有涉及的药物范围广、疾病的种类多、发病机制复杂、起病方式差异大等特点。本文综述了可导致药物性肺炎、肺纤维化、哮喘、肺水肿、肺栓塞、肺出血、肺癌、肺动脉高压、肺血管炎等疾病的药物及可能的致病机制。提示药源性肺部疾病在其诊断、治疗、预后及其潜在的用药危险因素等方面均应引起医师足够的重视。
  • 论著
    Zhou Li;Wu Chunqi;Wang Qingxiu;Yang Baohua;Liao Mingyang
    . 2008, 10(6): 0-0.
    Objective: To study the dose-effect and time-effect relations to spermatogenic cell apoptosis of rats induced by hydroxyurea. Methods:In the dose-effect study, 25 male Wistar rats were divided into 5 groups (5 rats in each groups). Of the 5 groups, 4 were the test groups and 1 was the control group. Each of the four test groups was administered with a different dose of hydroxyurea (100 mg/kg, 200 mg/kg, 400 mg/kg, and 600 mg/kg) by intraperitoneal injection, respectively. The control group was administered with phosphatebuffered solution 2 ml/kg. All rats were killed 12 hours after dosing. In the timeeffect study, 20 male Wistar rats were divided into 4 groups(5 rats in each groups). Of the 4 groups, 3 were the test groups and 1 was the blank control group. The three test groups were administered with hydroxyurea 400 mg/kg by intraperitoneal injection. All rats were killed 6, 12, and 24 hours after dosing. The dead rats and their testes were weighed. The testes were fixed in Bouin's solution and then stained with hematoxylineosin. Morphological changes were observed under light microscope. The TUNEL staining of apoptotic cells and PAS staining for glycogen were performed. The number of apoptotic cells was counted and the stages of seminiferous epithelial cycle were analysed. Results: There were no significant changes in weights of body and testis 6, 12, and 24 hours after dosing compared with before dosing. The results of the doseeffect study showed the rates of apoptoticpositive seminiferous tubule and apoptotic index were markedly elevated with the increase in doses, especially in 400 mg/kg \[(38.7±2.0)% and (496.4±66.8), respectively\] (P<0.01). The results of the timeeffect study showed the mean number of apoptoticpositive spermatogenic cell and apoptotic index reached a peak at 12 hours after dosing \[(12.9±2.10) and (496.4±66.8), respectively\] compared with the control group. TUNELpositive cells were mainly in stage Ⅰ~Ⅳ of seminiferous cycle. Conclusion: The spermatogenic cell apoptosis of rats induced by hydroxyurea is cell-specific and stage-specific.
  • 安全用药
    . 2006, 8(4): 269-272.
    环磷酰胺是临床常用的一种细胞毒药物,适用于多种实体瘤、白血病的治疗,但其代谢产物可产生严重的出血性膀胱炎。本文对其所致出血性膀胱炎的机制、防治、监测等问题进行概述,以期引起临床重视,提高用药的安全性和有效性。
  • 安全用药
    . 2005, 7(2): 106-108.
    近年,药源性肌病的报道有所增加,本文概要介绍不同类型肌病的临床表现与致病药物及其作用机制,旨在提高临床的诊断能力和安全用药水平。
  • Jiang Rongmeng, Song Meihua
    Adverse Drug Reactions Journal. 2020, 22(1): 2-5. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.01.002
    Special populations, such as infants, pregnant and lactating women, patients with liver and kidney dysfunction, and the elderly, have different degrees of immune dysfunction, whose probability of infection and the utilization rate of antibacterials are higher than those in other populations. The risk of adverse reactions is higher in these special populations because of their special pathophysiological state and characteristics of drug metabolism. Therefore, more attention should be paid to the safety of antibacterials in these populations. To master the pathophysiological characteristics of special populations and the pharmacokinetic characteristics of the antibacterials and strengthen the audit and comment on the prescription of antibacterials in the special populations will help to improve the level of rational use of antibacterials, so as to reduce their damages to special populations.
  • Liang Liang, Wang Ting, Feng Ru, Chen Di, Jin Pengfei
    Adverse Drug Reactions Journal. 2021, 23(10): 523-534. https://doi.org/10.3760/cma.j.cn114015-20210209-00171
    Objective To evaluate the safety of venetoclax alone or combined with CD20 monoclonal antibody (mAb) in treatment of patients with relapsed/refractory chronic lymphoblastic leukemia (R/R CLL). Methods Databases of PubMed, Embase, CNKI, Wanfang Med Online, VIP, and SinoMed and websites such as ClinicalTrials.gov, the U.S. Food and Drug Administration (FDA), and the European Drug Administration (EMA) were searched. The clinical studies with safety indicators of venetoclax alone or in combination with CD20 mAb in treatment of patients with R/R CLL were collected. Safety-relevant data were extracted and the meta-analysis was performed using R software. The effect values were the ratio of relative risk (RRR) and 95% confidence interval (CI). Results A total of 9 studies were enrolled in the analysis, all of which were single arm studies (8 prospective studies and 1 retrospective study). Eight hundred and nineteen patients were involved in the 9 studies, 719 of which were in the monotherapy group and 100 in the 2-drug combination group. The most common adverse events in venetoclax monotherapy or combined with CD20 mAb were hematologic adverse events. The risk of developing grade 3-4 neutrophilia, thrombocytopenia, and anemia was 46.96% (95%CI: 40.27%-53.76%), 20.46% (95%CI: 14.79%-27.59%), and 15.31% (95%CI: 10.30%-22.15%), respectively. Other grade 3-4 adverse events mainly included infection [17.79% (95%CI: 15.15%-20.77%)], tumor lysis syndrome [3.00% (95%CI: 1.75%-5.09%)], increased blood glucose [5.98% (95%CI: 3.80%-9.29%)], and hypokalemia [4.27% (95%CI: 2.54%-7.08%)]. Due to the adverse events, 28.82% (95%CI: 16.56%-45.24%) of patients interrupted venetoclax treatment for at least one dose, 17.19% (95%CI: 10.96%-25.94%) of patients reduced the venetoclax dose, 9.56% (95%CI: 7.64%-11.89%) of patients permanently discontinued venetoclax, and 1.90% (95%CI: 0.86%-4.17%) of patients died. Risks of grade 3-4 neutropenia and dose reduction of venetoclax were significantly higher in patients treated with venetoclax combined with CD20 mAb than in those treated with venetoclax alone (57.00% vs. 41.69%, RRR=1.36,95%CI: 1.12-1.66; 38.18% vs. 14.97%, RRR=2.55, 95%CI: 1.48-4.39). Conclusions The adverse events in venetoclax treated R/R CLL were mainly hematological adverse events and the risk of grade 3-4 neutropenia was more than 40%. After the combination with CD20 mAb, the risks of the other adverse events did not increase except for those of grade 3-4 neutropenia and dose reduction of venetoclax due to adverse events.
  • Sun Xue, Zeng Hua, Cidan Zhuoga, Deji, Zebi, Zuo Wei, Cidan Zhuoga
    Adverse Drug Reactions Journal. 2021, 23(11): 609-611. https://doi.org/10.3760/cma.j.cn1140152021022200194
    A 50yearold female patient was treated with diammonium glycyrrhizinate enteric coated capsules for about 22 months irregularly due to repeated abnormal liver function, which was changed to compound glycyrrhizin 3 tablets thrice daily later. After 4 months of treatment with compound glycyrrhizin, the patient developed myalgia with fatigue and the symptoms gradually aggravated, resulting in weakness of limbs and difficulty in walking. Compound glycyrrhizin were stopped for 1 week, but the symptoms were not improved, with a blood pressure of 160/100mmHg. Laboratory tests showed blood potassium 1.9mmol/L, alanine aminotransferase (ALT) 54U/L, aspartate aminotransferase (AST) 104U/L, creatine kinase (CK) >2200U/L, myoglobin 542.1μg/L, and blood pH 7.56. Intravenous and oral potassium supplementation and symptomatic treatments were given. Three days later, the symptoms of myalgia and fatigue were markedly improved and the blood potassium returned to 3.5mmol/L. Two weeks later, the patient′s muscle strength recovered and the blood pressure was 100/71mmHg. Laboratory tests showed blood potassium 4.2mmol/L, ALT 45U/L, AST 38U/L, and CK 44U/L. Aldosterone postural stimulation test and captopril challenge test were performed for definite diagnosis, showing normal aldosterone level and decreased renin concentration. Pseudoaldosteronism complicated with hypokalemic rhabdomyolysis was diagnosed, which was considered to be related to longterm administration of glycyrrhizic acid preparations.
  • 病例报告
    Zou Lia;Wang Lulub
    . 2008, 10(3): 216-2.

    A 44yearold woman was hospitalized after she had undergone left oviducal adenocarcinoma surgery and received the fifteenth chemotherapy. On day 2 after admission, the patient was infused with paclitaxel 180 mg intravenously, and no adverse reactions occurred. On day 3, the woman was infused with cisplatin 100 mg intravenously. After about 5 minutes of infusion, she developed palpitation, nausea, chest distress, hidrosis, and disturbance of consciousness. Her blood pressure decreased from 116/74 mmHg to 74/43 mmHg. Anaphylactic shock was diagnosed. Cisplatin was discontinued immediately, and her symptoms resolved after antianaphylactic and symptomatic treatment.

  • Si Jigang
    . 2017, 19(1): 54-55.
    A 25-year-old male patient with  bacterial gastroenteritis received an IV infusion of amikacin 0.4 g which was dissolved in 5% glucose injection 250 ml. At the end of the IV infusion of amikacin, the patient developed muffled feeling in his left ear accompanied by hearing loss. About 11 hours later, the patient′s left ear developed tinnitus and aggravation of  hearing loss.  It was considered that the tinnitus and  hearing loss were induced by amikacin. Amikacin was withdrawn immediately. He received the symptomatic treatment including  intravenous injections of  alprostadil, mecobalamin, citicoline sodium and  sodium cytidine triphosphate, intramuscular injection  of  mouse nerve growth factor, and the prednisone acetate tablets orally. Twenty-seven days later, his symptom of tinnitus disappeared, and the audition returned to normal.
  • 综述
    . 1999, 1(3): 139-145.
  • 安全合理用药
    Wen Shaojun;Liu Jielin;Liu Ya;Wang Zuoguang
    . 2007, 9(3): 172-176.
    Understanding of adverse reactions to antihypertensive drugs is of important clinical significance for long-term therapy of hypertension. This paper provide a review of the potential adverse reactions to antihypertensive drugs such as heart depression, renal damage, potassium abnormality, etc. The purpose of this review is to benefit the prevention of serious adverse reactions and improvement of medication compliance of patients with hypertension.
  • 安全用药
    Li Dan;Ren Aimin;Wang Hong
    . 2010, 12(4): 262-7.
    ABSTRACT Antibioticassociated colitis (AAC) mainly occurs 3 to 14 days after the initiation of antibiotic treatment. The incidence among inpatients is 3%29%. The underlying pathological change of AAC is imbalance of intestinal flora caused by application of broadspectrum antibiotics. The pathogenesis mechanism is that antibiotics suppress the normal intestinal flora, and then excessive growth of pathogenic and resistant bacteria occurs. The main pathogenic bacterium is Clostridium difficile(CD),which produces toxin A and toxin B that injure the intestinal mucosa, make mucin leak, and eventually cause diarrhea. Except CD, methicillin resistant Staphylococcus aureus (MRSA) and Klebsiella species are also pathogenic bacteria of AAC. According to the clinical manifestations,AAC can be divided into three types: mild type characterized by watery diarrhea, severe type by yellow or light green watery diarrhea, abdominal pain, fever, and elevated white blood cells, and fulminant type by diarrhea, high fever, dehydration, hypoproteinemia, toxic shock, intestinal paralysis, even acute intestinal perforation. After the diagnosis of AAC is confirmed, the drugs being in use should be withdrawn immediately. Treatment of metronidazole and vancomycin for 7-10 days can be given, and probiotics can be utilized in addition. For the recurrent cases, vancomycin can be used at a dosage of 125 mg in a regressive manner, and combined with human immune globulin therapy. In order to prevent AAC,the drug indication for antibiotics should be strictly controlled clinically. When the use of broadspectrum antibiotics are neccessary, the intestinal barrier function and normal flora should be monitored. Glutamine and arginine can be added to improve the intestinal immune function.
  • 调查研究
    Li Xiuhe;Zhang Ping
    . 2004, 6(5): 303-305.
    Objective: To observe the efficacy of tiopronin in children with liver damage caused by high dose methotrexate. Methods:In 103 cases,tiopronin injection was for the management of chemotherapy-induced liver damage. And Stronger Neo-Minophagen C was used in 42 cases as control. Results: In tiopronin group, 33 percent of cases maintained normal liver function, and the remaining developed liver damage, which would resolve if tiopronin administration continued. As for the efficacy, no statistical difference was observed between treatment group and control group(P> 0.05). Conclusion: Tiopronin can effectively prevent liver cells and improve liver function, and can be combined with methrexate in treatment of children with acute lymphoblastic leukemia.
  • Chen Tao, Huang Lihua, Xing Xiaoyan, Kong Xiaomu, Tu Mei
    Adverse Drug Reactions Journal. 2020, 22(10): 577-578. https://doi.org/10.3760/cma.j.cn114015-20190920-00777
    A 69-year-old female patient with type 2 diabetes mellitus received an IV infusion of alpha thioctic acid injection 0.6 g dissolved in 0.9% sodium chloride injection 250-ml for peripheral neuropathy. Eighteen hours after drug withdrawal, the patient had a sudden cold sweat with fatigue, dizziness, and hunger at night. After that, the patient repeatedly had paroxysmal cold sweat with dizziness and fatigue at night, which could be relieved after eating. The peripheral blood glucose at onset of symptoms was 2.1-mmol/L. Laboratory tests showed that fasting insulin was more than 6-945-pmol/L, insulin autoantibody was positive, and insulin release index was more than 29.00. The patient was diagnosed as having autoimmune hypoglycemia, which was considered to be related to alpha thioctic acid injection. Prednisone acetate 10-mg was given orally, thrice daily. Her symptoms of hypoglycemia were relieved 3 days later and disappeared 5 days later. Thereafter, prednisone acetate dose was gradually reduced to 1.25-mg/d and stopped about one year and 7 months later. During the treatment, her insulin autoantibody turned negative, serum insulin returned to normal, and hypoglycemia did not recur.
  • 综述
    Zeng Yan;Chu Yanqi;Wang Yuqin
    . 2007, 9(5): 305-310.
    The incidence of malformations is two to three times greater in the fetus of epileptic mothers than in the fetus of normal mothers,and antiepileptic drug is the main cause of fetal malformations.The fetal malformations are caused by not only the traditional antiepileptics,such as valproate,carbamazepine,phenobarbital,and phenytoin but also the new antiepileptics,such as lamotrigine,topiramate,oxcarbazepine,levetiracetam,and vigabatrin,which have been confirmed by the animal experiments and published case reports.The incidence of fetal malformations is 4.2% to 7.6% in pregnant women receiving antiepiletics.The malformation rate of polytherapy of antiepiletics(6.0%10.9%)is greater than that of monotherapy(3.7%6.9%).The most common clinical manifestations of fetal malformations caused by antiepileptics are craniofacial abnormalities,distal phalanges hypoplasia,congenital heart defects,microcephaly,neural tube defects,and hemorrhagic tendency.Possible mechanisms for a teratogenic action …更多of antiepileptics include causing folic acid deficiency,ion channels blockage,and neuron degeneration.The epileptic women who are pregnant or thinking about becoming pregnant should be careful of the rational choice and use of antiepileptics according to the types,frequency,and cause of seizures.During the treatment with antiepileptics,the monotherapy should be given,so far as possible,dosage should be kept to the minimum necessary to control fits,the serum concentration should be monitored,and prenatal check-up should be performed in order to reduce or avoid the occurrence of fetal malformations.
  • 药物评介
    . 2006, 8(6): 463-466.
  • 病例报告
    Liu Wen;Chen Hui;Chen huiying
    . 2008, 10(6): 0-0.

    A 41-year-old woman with adhesive ileus underwent terminal ileum resection. The woman was given intravenous injection of hemocoagulase 1 KU dissolved in 20 ml of sodium chloride 0.9% after surgery, once every two hours for three times. No adverse reactions occurred after receiving the first and second dose of the medication. However, during the third infusion, the patient abruptly developed unconsciousness, sighing respiration, cyanosis of lips, pale face, bilateral mydriasis, and cardiac arrest. The infusion was stopped immediately. She underwent closed-chest cardiac message and oxygen with assisted mask ventilation. Lidocaine, adrenaline, and atropine were given intravenously. Thirty minutes later, her heart beat and respiration recovered.

  • 安全用药
    . 2003, 5(1): 18-21.
    本文对引起药源性低钾血症的药物、临床表现、致病机理、防治措施进行简要介绍,供临床用药参考。
  • 病例报告
    Yang Bilian;Li Yuanwen;Sun Zhanxue;Li Nan
    . 2008, 10(6): 0-0.

    A 63yearold woman with a 4month history of diabetes took glipizide and acarbose without adverse reactions occurring. Later, the woman received oral famciclovir 0.25 g thrice daily for herpes simplex. Two hours after the first administration, she experienced dizziness, nausea, vomiting, abdominal pain, and diarrhea. Intestinal infection was excluded by stool examination. Famciclovir was withdrawn and switched to an IV infusion of aciclovir 0.5 g once daily. Glipizide and acarbose were continued. Meanwhile, fluid replacement and symptomatic therapy were given. The following day, her dizziness and gastrointestinal symptoms disappeared completely. The patient continuously received IV infusion of aciclovir for four days. Her herpes simplex was entirely crusted and she was fully cured and discharged.

  • 安全用药
    Yu Aihea;Zhang Xiaoshub
    . 2009, 11(2): 106-5.
    There is an increasing tendency for combined use of antischizophrenic drugs in recent years. This paper now briefly reviews the efficacy and safety to clozapine or olanzapine combined with other antischizophrenic drugs. Clozapine in combination with sulpiride is relatively definite in efficacy, but it may cause increased serum prolactin level or aggravated extrapyramidal disorders. Clozapine combined with amisulpride seems to be effective in complete improvement of patients’condition, but increased serum prolactin level may occur. Clinical trials for efficacy and safety of clozapine in combination with risperidone show different results. Olanzapine combined with some other classical antipsychotic drugs may increase some degree of therapeutic effects. Olanzapine in combination with risperidone appear to be beneficial to improvement of symptoms in patients with refractory schizophrenia. The author considers that the benefit and risk of the combinations mentioned above should be evaluated further in order to benefit to rational and safe use of the drugs.
  • 病例报告
    JI Cui-fang;XIAO Yi-wen;XU Ping;PENG Wen-xing;YUAN Hai-yan
    . 2012, 14(6): 398-3.
    A 57-year-old man took carbamazepine 0.1 g twice daily for epilepsy secondary to traumatic brain injury. Twelve days later, he developed purple patches on his trunk, which rapidly progressed to involve his face and neck. Meanwhile, skin and mucosal erosion appeared on his mouth, eyes and genitalia, accompanied by high fever. Carbamazepine was stopped. Two days later, blisters occurred on the part of erythematous skin, and then blisters ruptured and formed skin erosion. Carbamazepine-induced toxic epidermal necrolysis was diagnosed. He was treated with methylprednisolone, cefamandole nafate, compound glycyrrhizin, reduced glutathione, polyene phosphatidylcholine, and human immunoglobulin. His rashes gradually subsided. One month later, the erosion basically healed.
  • 调查研究
    Chen Chao;Liu Ping;He Peihong;Zhou Jian
    . 2003, 5(3): 159-162.
    Objective:To discuss adverse reactions to ciprofloxacin.Method:239ADR reports of ciproloxain of PLA Center for ADR Monitoring from January1999to December2001were classified and analyzed.Results:The adverse effects involved16organs/systems,with the most frequent in skin and its appendages(49.26%),followed by phlebitis(20.96%),systemic reactions(5.88%),damages in gastro intestinal tract(7.35%),CNS and PNS(4.41%),hepatobiliary system(2.57%),and mental disorder(2.21%).And allergic shock,hematuria,abnormal cardiac rhythm,impair ment of muscle,bone and blood occurred occasionally.Conclusion:In view of the occurrence of above-mentioned ad verse effects,care is ad vis able in patients re ceiv ing ciprofloxacin therapy.
  • 调查研究
    Chen Aiqun;Jia Jinsheng;Li Li
    . 2003, 5(3): 162-165.
    Objective:To understand adverse effects of Mailuoning injection.Method:Literature was retrieved from do-mestic medical journals1992-2001,and70cases with the adverse effects in49papers were collected and analysed.Re sults:The ad verse effects were mainly allergic shock(33.33%),then disorders in cardiovascular system,skin,respiratory function,urinary system,and serum sickness like reaction,etc.Conclusion:Mailuoning injection should be used with care because of its frequent adverse effects.
  • 专题讲座
    . 2005, 7(5): 363-367.
  • 安全用药
    Yan Xuelian;Zhang Cuilian;Li Dakui
    . 2009, 11(6): 420-5.
    Ceftriaxone is a thirdgeneration cephalosporin antibiotic which is used widely in clinical practice. The common adverse reactions to ceftriaxone are allergic reactions and gastrointestinal disorders. Ceftriaxone also causes hemolytic anemia which is being reported with increasing frequency recently. The authors have searched the foreign and domestic literature, and there have been 21 cases of immune hemolytic anemia caused by ceftriaxone. Of them, there have been 16 cases reported in the foreign literature including 8 deaths, and 5 cases reported in the domestic literature including one death. Generally, the dosage of ceftriaxone is 1~4 g. The time to hemolytic reaction onset is several minutes to days after ceftriaxone administration. Clinical presentations include dizziness, palpitation, short of breath, lumbago with hematuria, proteinuria; hemoglobin values were lower than the normal level, direct Coombs test was positive. The mechanism is attributed to immunecomplex reactions. Ceftriaxoneinduced immune hemolytic anemia is rare, but its mortality is high. If hemolytic reactions occur, ceftriaxone should be stopped, IV dexamethasone and a washed RBC infusion should be administered, and the urine should be alkalised.
  • 论著
    Liu Yongjiao;Yang Jing
    . 2014, 16(6): 341-4.
    ObjectiveTo analyze the status of medication error (ME) of outpatient pharmacy of Beijing Tongren Hospital Affiliated to Capital Medical University and to find effective prevention and control measures.MethodsAs a pilot run hospital of Beijing Municipal Health Bureau ME monitoring system, ME cases were reported since August 2011 by the hospital and ME reports were analyzed monthly to formulate prevention measures. ME cases of outpatient pharmacy, which were reported to Beijing Municipal Health Bureau, from August 2011 to March 2013 were collected. The ME cases were classified according to the ME classification standard of The National Coordinating Council for Medication Error Reporting and Prevention and the links in which ME cases occurred were analyzed. MEs that occurred from August 2011 to September 2012(the pilot operation stage of the Beijing ME monitoring system) were compared with those from October 2012 to March 2013( the operation stage of Beijing municipal bureau of clinical medication safety monitoring network). The effectiveness of prevention measures was evaluated.ResultsA total of 506 ME cases, accounting for 0.031%(506/1 636 429)of the number of outpatient prescriptions at the same time, were collected. There were 2 cases of category A (potential error problems), 462 cases of category B (errors happened but the drug was not given to patient, or the drug had been given to patient but was not taken), 42 cases of category C (patients had used the drug but not be harmed), and none of categories D-I. Among them, 459 ME cases occurred in the links of prescriptions by doctors including improper usage and dosage(75.16%, 345/459), improper administration route(12.64%, 58/459), improper drug selection(5.88%, 27/459), taking medication within comtraindication(3.05%, 14/459),imcompatibility(2.61%, 12/459), and improper choice of solvents(0.65%, 3/459). Forty-seven ME cases occurred in the links of dispensing prescriptions by pharmacists including sound alike, look alike, adjacent locations, and so on. Aiming to the links of doctors making prescriptions, a supervision model of "four-grade prescription comment and four-grade feedback" was carried out since October 2012 and the rate of qualified prescriptions was increased effectively. The proportion of ME cases in the links of prescriptions by doctors in all the prescription cases during the same period decreased from 0.035% (398/1 139 613) in the pilot operation stage to 0.012% (61/496 816) in the operation stage. Aiming to the links of dispensing prescriptions by pharmacists, many kinds of measures were carried out to improve the identification of easily confused drugs. The incidence of ME in the links of dispensing prescriptions by pharmacists decreased from 0.004% (40/1 139 613) in the pilot operation stage to 0.001% (7/496 816) in the operation stage.ConclusionThe ME cases in outpatient pharmacy of Beijing Tongren Hospital Affiliated to Capital Medical University were mainly category B and C and mostly occurred in the links of prescriptions by doctors. The main type of ME was usage and dosage. The supervision model of "four-grade prescription comment and four-grade feedback" could effectively prevent the ME in the links of prescriptions by doctors.
  • 综述
    Yang Xue;Xue Yu;Zou Hejian
    . 2014, 16(3): 168-3.
    Febuxostat is a new type of selective xanthine oxidase inhibitor, which mainly be used for the treatment of hyperuricemia patients with gout symptoms. The recommended initial dose of febuxostat is 40 mg once daily. In the present, there is no sufficient evidence to demonstrate that the clinical effects of febuxostat in reducing the uric acid are better than that of allopurinol. However, it is reported that febuxostat in 80 mg has better treatment effects in gout patients with diabetes or ≥ 65 years old. The common adverse reactions of febuxostat are liver dysfunction, diarrhea, headache, nausea, rash, and so on. The differences of adverse reactions in cardiovascular system between febuxostat and allopurinol are not statistically significant.
  • 综述
    . 2004, 6(1): 1-8.
    本文对近年来新核苷类药物治疗乙肝的研究现状进行综述,主要介绍在我国即将上市的阿德福韦、恩替卡韦抗乙肝病毒效果和临床安全性的研究概况,以及依曲西他平、替诺福韦等新开发药物的研究现状。旨在使临床医生对新核苷类药物治疗乙肝的合理性和安全性有更深刻的了解。
  • 安全用药
    . 2005, 7(5): 348-350.
    莪术油葡萄糖注射液是一种抗菌、抗病毒的中药制剂。因其疗效较好而广泛用于临床,但近年来,其不良反应报道增多,常见过敏反应;少见鼻出血,腹痛;罕见血尿。虽然反应程度较轻,发生率低,但偶尔可发生严重过敏性休克。本文就莪术油葡萄糖注射液的主要不良反应及其防治作一简要介绍,旨在对其安全性引起关注。
  • 病例报告
    Yuan Xiaoying;Zheng Wei
    . 2008, 10(6): 0-0.
    42year-old man with pustular psoriasis was treated with acitretin capsules 30 mg once daily. His routine blood test was basically normal before therapy. He had a RBC count of 3.65×1012/L, a WBC count of 9.5×109/L, and a PLT count of 246×109/L. One week after administration, his RBC was 3.67×1012/L, his WBC was 16.5×109/L, and his PLT was 412×109/L, respectively. Pathological examination showed thrombocytosis and bone marrow hyperplasia. An ultrasound examination showed splenomegaly. The dosage of acitretin was reduced to 15 mg/day. Three weeks later, a reexamination revealed a RBC count of 3.72×1012/L, a WBC count of 14.3×109/L, and a PLT count of 446×109/L. The dosage of acitretin was continuously reduced to 10 mg/day. Two weeks later, a reexamination revealed a RBC count of 3.48×1012/L, a WBC count of 10.3×109/L, and a PLT count of 385×109/L. No abnormal abdominal findings were observed on ultrasound examination.
  • Adverse Drug Reactions Journal. 2022, 24(7): 360-364. https://doi.org/10.3760/cma.j.cn114015-20220321-00218
    Objective To explore the effect of amiodarone on warfarin′s time in therapeutic range (TTR), daily dose of warfarin, and the occurrence of over anticoagulation in patients treated with warfarin after heart valve surgery. Methods Demographic information and clinical information of patients taking warfarin for heart valve surgery in the anticoagulation clinic in Fuwai Hospital of Chinese Academy of Medical Sciences from November 2019 to January 2021 were collected. The patients were divided into amiodarone group and control group according to whether they were treated with amiodarone. The percentage of TTR, stable daily dose of warfarin, and the proportion of times of INR>3 in patients in the 2 groups within 90 days of outpatient follow-up were retrospectively analyzed. Results A total of 407 patients were included in the study. There were 35 patients in the amiodarone group, including 15 males and 20 females, with a median age of 56 (49, 64) years, in which 20 (57.1%) had concomitant atrial fibrillation (AF). There were 372 patients in the control group, including 227 males and 145 females, with a median age of 55 (48, 63) years, in which 105 (28.2%) with AF. Within 90 days of discharge, the difference of percentage of TTR between the amiodarone and control groups was not significant [57.6% (44.6%, 70.6%) vs. 67.3% (52.3%, 82.3%), P=0.061], but the stable daily dose of warfarin in patients in the amiodarone group was significantly lower than that in patients in the control group [2.25 (1.72, 2.78) mg vs. 3.38 (2.59, 4.18) mg, P<0.001]. The median proportion (range) of times of INR>3 in the 1-14 days, 15-90 days after discharge and the whole follow-up period in patients in the amiodarone group were higher than those in the control group[0 (0-0.3) vs. 0(0-0.3), P=0.016; 0.08(0-0.3) vs. 0(0-1.0), P=0.002; 0.06(0-0.85) vs. 0(0-0.22), P=0.001]. Conclusions Amiodarone can significantly increase the risk of anticoagulation in patients treated with warfarin after heart valve surgery. The daily dose of warfarin needs to be reduced in order to achieve a higher TTR and maintain the stability of anticoagulation therapy.
  • Peng Jin'e, Liu Hui, Li Xiao, Wang Lijun, Wang Shuo, Su Haofan, Zhan Hanqiu, Zhang Wei
    Adverse Drug Reactions Journal. 2023, 25(1): 11-16. https://doi.org/10.3760/cma.j.cn114015-20220812-00739
    Objective To explore the safety of nirmatrelvir/ritonavir (Paxlovid) in the treatment of coronavirus disease 2019 (COVID-19). Methods Medical records of adult patients with COVID-19 who were hospitalized and treated with Paxlovid in Beijing Ditan Hospital, Capital Medical University between March 23 and May 31, 2022 were collected through the hospital electronic medical record system. The occurrence (time of occurrence, clinical manifestations, severity, etc.) and outcomes of adverse reactions were analyzed retrospectively and the clinical characteristics of patients with or without adverse reactions were compared. Paxlovid was administered orally with nirmatrelvir 300-mg and ritonavir 100-mg every 12-hours for 5 consecutive days. Results Three hundred and sixty-four patients were entered in the analy- sis, including 200 males (54.9%) and 164 females (45.1%), with a median age of 60 (19, 92) years. The incidence of adverse reactions of Paxlovid was 13.2% (48/364), and the adverse reactions occurred 1 to 7 days after taking Paxlovid. Among the 48 patients, 37 patients had digestive system symptoms (mainly manifested as diarrhea in 17 patients, bitter mouth in 14 patients, etc.), 7 patients had nervous system symptoms (dizziness in 5 patients, headache in 2 patients), 4 patients had respiratory system symptoms (pharyngalgia in 3 patients, pharyngeal itching in 1 patient), 2 patients had kidney injury, 1 patient had elevated blood uric acid, 1 patient had myalgia, and 1 patient had rash. Of them, 2 patients had digestive and neurological symptoms at the same time, 1 patient had digestive and respiratory symptoms at the same time, and 1 patient had digestive, neurological, and respiratory symptoms at the same time. The severity of adverse reactions was grade 1 in 33 patients (68.8%) and grade 2 in 15 patients (31.2%), and no serious adverse reactions of grade 3 and above occurred. All patients completed 5 days of treatment except 1 patient who discontinued the drug because of intolerance to grade 2 digestive symptoms (nausea and bitter mouth). There were no significant differences in gender, age, body mass index, smoking status, underlying diseases, and COVID-19 clinical classification between the patients with and without adverse reactions (all P>0.05). Conclusions Paxlovid has a good safety in the treatment of COVID-19. The main adverse reaction is digestive system symptoms, mainly diarrhea and bitter mouth. Most of the symptoms are mild and the patient′s tolerance is good.
  • 安全用药
    . 2002, 4(6): 383-385.
  • Adverse Drug Reactions Journal. 2020, 22(10): 606-606. https://doi.org/10.3760/cma.j.cn114015-20201008-01010
  • 病例报告
    Chen Yuhuang①;Tang Yonglin②;Wang Xizhen②
    . 2007, 9(4): 290-290.
    A 17-year-old man was given hydroxyethyl starch 130/0.4 sodium chloride injection 500 ml by intravenous infusion at a rate of 300 ml an hour after the operation for abdominal incised wound.About 20 minutes after the initiation of infusion,the patient developed restlessness,urticaria on the nape of his neck and his chest.After antianaphylaxis therapy,his urticaria disappeared.
  • 中药不良反应
    . 2007, 9(1): 66-66.
  • 调查研究
    Yi Zhanmiao;Liu Fang*Zhang JunLi XiaoguangZhai Suodi
    . 2010, 12(4): 251-4.
    Objective: To investigate the clinical characteristics of hematological adverse reactions induced by cinepazide in order to prevent their development. Methods: Cinepazide, adverse reaction, leucopenia, agranulocytosis, and thrombocytopenia were selected as the searchwords and PubMed(1948-2010),EMBASE (1966-2010), CBM(1978-2010), CNKI(1979-2010), VIP(1979-2010),WANFANG DATA(1989-2010) as well as Adverse Drug Reaction Monitoring Network of Beijing were searched. The literatures and the case reports of hematological adverse reactions induced by cinepazide were collected. The data were analyzed retrospectively, including characteristics of patients, drug use, as well as types, onset time, clinical manifestations, treatment and prognosis to adverse reaction. Results: A total of 14 clinical research papers and the adverse drug reaction reports were selected , 16 patients were enrolled in this study. They comprised 8 men and 8 women with average age of (73.0±11.9) years. The primary diseases were cerebral infarction (9 cases), cerebral hemorrhage (3 cases), peripheral arterial embolism (3 cases) and vertebrobasilar arterial insufficiency (1 case). Dosages of cinepazide were 160 mg/d (2 cases), 240 mg/d (2 cases), 320 mg/d (8 cases), 600mg/d (1 case) and 1 200 mg/d (3 cases), respectively. The onset time to adverse reaction induced by cinepazide was within 5 days (7 cases), 6 to 10 days (3 cases), 11 to 15 days (1 case) and more than 15 days (5 cases) after treatment, respectively. The initial symptom of adverse reactions in most patients was fever. There were 10 patients with leucopenia, 4 with agranulocytosis, 1 with thrombocytopenia and 1 with both leucopenia and thrombocytopenia,in total of 16 patients. Fifteen patients received the drug discontinuation and symptomatic treatment, 14 patients improved and 1 died. Another patient’s drug was not withdrawn. Conclusion: Cinepazide is liable to decrease leckocyte, franulocyte, and platelet. Clinical cinepazide use should be followed by a careful hematological monitoring.
  • 药源性疾病
    Liu Chen;Wang Yuqin
    . 2011, 13(6): 367-6.
    Osteoporosis is a skeletal disorder characterized by compromised bone strength that may predispose to an increased risk of fracture, which can seriously decrease the patient’s quality of life and healthy status. The common drugs causing osteoporosis are oral anticoagulants, calcineurin inhibitors, potent diuretics, proton pump inhibitors, thiazolidinediones, aromatase inhibitors, protease inhibitors, glucocorticoids, antiepileptic drugs, etc. The main mechanisms may involve promoting bone resorption, inhibition of bone formation and bone mineralization. Drug-induced osteoporosis is diagnosed by a bone mineral density test. The effective measures for preventing and treating drug-induced osteoporosis include rational drug use, regularly monitoring of bone mineral density, shortening the duration of therapy, and patients should be administered calcium, vitamin D supplementation, bisphosphonate, calcitonin, selective estrogen receptor modulator, and so on.
  • 药源性疾病
    Xu Saihui;Lei Zhaobao
    . 2007, 9(4): 273-276.
    Syncope refers to a temporary loss of consciousness due to brief generalized insufficient blood supply to the brain.The causes of syncope are myriad such as cardiovascular diseases,low blood glucose,drugs,and so on.Drug-induced syncope accounts for 2%~9%.Drug-induced sycope is classified into four types,I.e.cardiac syncope,orhostatic hypotensive syncope,vasodepressor syncope,and other syncope.Its clinical presentations are dizziness,palpitation,nausea,sweat,myasthenia of limbs,unconsciousness,fall,etc.The most common drugs are cardiovascular drugs,antipyretic analgesics,and antibacterials.The treatment for drug-induced syncope usually is cessation of the drug and to let the patient lie flat.But the method of treatment for cardiac syncope induced by drug varies with the patient's condition.The main preventive measures for drug-induced syncope include the choice of appropriate drug and dosage,control of concentration and speed to intravenous medication,caution in drug combinations,and enhancement of monitoring.
  • 安全用药
    . 2003, 5(4): 238-240.
    大剂量甲氨蝶呤(MTX)化疗,可导致造血系统损害、消化系统反应、肝肾损害等严重不良反应。如何应对不良反应的发生,将患者的痛苦减至最小是化疗成功的关键问题之一。本文根据有关文献并结合临床实际探讨大剂量MTX治疗骨肉瘤所致毒副反应及防治措施。
  • Liang Yu, Zhao Jun, Ni Beibei, Li Xiao, Guo Qie, Meng Zhen
    Adverse Drug Reactions Journal. 2023, 25(2): 89-94. https://doi.org/10.3760/cma.j.cn114015-20220927-00877
    Objective To know the clinical characteristics of liver injury related to thalidomide and its analogs. Methods The relevant databases at home and abroad (up to August 31, 2022) were searched and the case reports on thalidomide and its analogs-associated liver injury were collected. The patients′ gender, age, primary disease, drug use, occurrence of liver injury (onset time, clinical manifestations, liver function status, liver injury classification, etc.), treatment and outcome were recorded and descriptively analyzed. Results A total of 18 patients were enrolled, including 11 males and 7 females, aged from 36 to 93 years with an average age of 60 years. The primary disease was multiple myeloma in 16 patients, plasma cell leukemia and myelodysplastic syndrome in 1 patient each. Thalidomide was used in 9 patients, lenalidomide in 6 patients and pomalidomide in 3 patients. The time from the beginning of medication to the occurrence of liver injury ranged from 4 to 232 days and it was ≤ 60 days in 15 patients. The classification of liver injury was hepatocellular type in 9 patients, cholestasis type in 7 patients, and unable to be determined due to lack of data in 2 patients. Different degrees of abnormal liver function appeared in 18 patients, mainly including elevated alanine aminotransferase and aspartate aminotransferase (in 16 patients), elevated total bilirubin (in 14 patients), and elevated alkaline phosphatase (in 12 patients). Clinical symptoms were recorded in 15 patients, including jaundice (in 13 cases), fatigue (in 7 cases) and nausea (in 4 cases). After diagnosis of liver injury, thalidomide or its analogues were discontinued in all 18 patients, and 4 cases received symptomatic and supportive therapy. Liver function in 13 patients was improved or returned to normal within 7 to 28 days after drug withdrawal, and 5 patients died (2 cases died of liver failure, 3 cases died of primary diseases or other complications). Conclusions Thalidomide and its analogs associated liver injury mostly occurs within 2 months after drug administration and the clinical symptoms were similar to those caused by other drugs. After drug withdrawal, the liver function in most patients could be improved or return to normal, but a few may progress to liver failure and death.
  • Huang Meixia, Li Qun, Wang Yingzheng, Liao Huajun, Wang Yinghao, Wu Shuisheng
    Adverse Drug Reactions Journal. 2022, 24(1): 7-12. https://doi.org/10.3760/cma.j.cn114015-20210719-00798
    Objective To explore the relationship between high performance liquid chromato- graphy (HPLC) fingerprint and toxicity of Gelsemium elegans fermented by Ganoderma lucidum (Ganoderma lucidum-Gelsemium elegans) for different time. Methods Gelsemium elegans was processed by biphasic solid-state fermentation with Ganoderma lucidum. A total of 10-samples of Ganoderma lucidum- Gelsemium elegans were collected after fermentation for 9, 11, 13, 15, 17, 19, 21, 23, 25, 27 days (sampling twice on day 27, number: S1-S10) and the fingerprints were determined by self-established HPLC. One hundred specific pathogen-free ICR mice were randomly divided into 10 groups (each group comprised 10 mice, half were male and half were female). The median lethal dose of Ganoderma lucidum-Gelsemium elegans collected after fermentation for 11 days in mice was used as the final concentration in toxicity test. S1-S10 Ganoderma lucidum-Gelsemium elegans solutions were prepared and given to 10 groups of mice respectively by gavage administration and the death of mice was observed. According to the calculation formula of grey correlation analysis, the correlation coefficients between the common peaks of S1-S10 Ganoderma lucidum-Gelsemium elegans in chromatographic fingerprint and their toxicity test results (death rate in mice) was calculated and the main components contributing to the toxicity of Ganoderma lucidum-Gelsemium elegans were analyzed. Results A total of 17 common peaks were identified in the chromatographic fingerprint spectrum of S1-S10 Ganoderma lucidum-Gelsemium elegans. The mortalities in mice caused by S1-S10 of Ganoderma lucidum-Gelsemium elegans were 1.00, 1.00, 0.80, 0.70, 0.60, 0.60, 0.50, 0.40, 0, and 0, respectively. The grey correlation analysis showed that the correlation coefficients of common peak 7, 3, 6, 9, 1, 8, 17, and 12 to toxicity were 0.868, 0.838, 0.830, 0.828, 0.824, 0.820, 0.818, and 0.802, respectively. The chemical components represented by these 8 chromatographic peaks had more contribution to the toxicity of Ganoderma lucidum-Gelsemium elegans. Conclusions With the extension of fermentation time, the toxicity of Ganoderma lucidum-Gelsemium elegans decreased gradually, and toxicity was the lowest at 27 days of fermentation. The toxicity of Gelsemium elegans after fermentation was the result of a join action from multiple components. The identification of the main toxicity components can provide a reference for the quality control of Ganoderma lucidum-Gelsemium elegans and the fermentation process optimization.
  • 药物评介
    . 2007, 9(1): 62-66.
    他克莫司软膏为大环内酯类免疫调节剂,是治疗特应性皮炎(AD)的非皮质类固醇类外用制剂,他克莫司可抑制钙调磷酸酶的活性及阻止多种细胞因子生成,从而抑制T淋巴细胞活化,发挥药理作用。临床用于治疗AD疗效确切,不良反应较少。本文对他克莫司软膏的药理特性、临床应用和不良反应进行概述,供临床合理应用参考。
  • Wang Rui, Wang Xiangfeng, Song Yanqing, Li Yueyang
    Adverse Drug Reactions Journal. 2020, 22(7): 428-429. https://doi.org/10.3760/cma.j.cn114015-20190220-00166
    A 6-year-old boy received VDLD chemotherapy regimen (oral dexamethasone 0.75-mg once daily on days 1-7; intravenous injection of vincristine 1.45-mg on the 7th, 15th, 21th, and 29th day; intravenous infusion of daunorubicin 29-mg on the 8th and 15th day; intramuscular injection of L-asparaginase 4-850 U on the 8th, 11th, 14th, 17th, 20th, 23rd, 26th, and 29th day) for acute B lymphoblastic leukemia. On the 7th day, vincristine was injected intravenously after oral administration of dexamethasone. About 7 hours later, the child developed distending pain in both eyes, blurred vision, headache, and vomi- ting. The measurement of binocular intraocular pressure showed 62-mmHg in the left eye and 61-mmHg in the right eye. It was diagnosed as acute secondary glaucoma in both eyes, which was considered to be related to dexamethasone and vincristine. Above-mentioned chemotherapy regimen was stopped and the treatment of reduction of intraocular pressure and conventional therapy for glaucoma were given. One week later, the child′s intraocular pressure returned to normal. Then chemotherapy regimen was changed and his symptoms of glaucomadid did not recur.
  • Luo Guoqing, Zhong Jianxun
    . 2017, 19(1): 52-53.
    A 69-year-old female patient suffered from cholestasis caused by acute viral hepatitis A was  treated with ursodeoxycholic acid  capsules  250 mg thrice daily. The patient developed facial flushing after a week. The symptoms relieved after the drug discontinuation. Three days later, the patient continued to take the medicine at the same dose, the symptom of facial flush recurred accompanied by facial swelling and systemic red rash. The medicine was discontinued immediately. The patient was under the treatment with IV infusions of vitamin C, calcium gluconate and methylprednisolone, intramuscular injection of diphenhydramine hydrochloride, oral loratadine and cetirizine hydrochloride, externally used calamine lotion, fluticasone propionate cream and fusidic acid cream. However, scattered bulla with clear liquid and cankered part appeared on the patient′s trunk skin, the diagnosis of drug eruption was made. She was given IV infusion of cefoperazone sodium and tazobactam sodium and oral mizolastine. One day later, the patient developed pain at lower limb skin, large red patches occurred on her thigh and trunk, double outer thighs with bulla of clear fluid, multiple target red patches on both legs with blisters of clear fluid. She was considered as having epidermolysis bullosa. She received an IV infusion of human immunoglobulin 20 g once daily. The target red patches were fused and formed diffuse erythema. After 3 days, the pain relived with the diffuse erythema faded away and the wizened bulla. After another two days, the blisters formed skin erosion in the thighs. After 3 days, the erosion was clean and dry, the dose of methylprednisolone was reduced. One week later, her liver function returned to normal. After 5 days, the erythema on the thigh and trunk appeared flake desquamation. Methylprednisolone was stopped and the patient received oral prednisone and externally used compound lactic acid ointment.
  • 安全用药
    Zhou Jianqiu;Mei Dan
    . 2011, 13(1): 27-5.

    Pharmaceutical packaging materials refer to packaging materials and containers which come into direct contact with medicines. Present major pharmaceutical packaging materials include the following four categories: glass, rubber, plastic, and metal materials. Pharmaceutical packaging materials might interact with the medicines which are packed. Some pharmaceutical packaging materials could absorb the active ingredient in medicines, thus decreasing their curative effects, and some may release hazardous substances, thus harming the body tissues. Therefore, quality control of pharmaceutical packaging materials should be strengthened; appropriate pharmaceutical packaging materials should be selected according to characteristics of medicines; and attention should be paid to drug safety problems associated with pharmaceutical packaging materials.

  • 综述
    . 2004, 6(3): 145-150.
    新开发的第Ⅳ代喹诺酮类药物中,有些对社区获得性呼吸道感染的主要病原体肺炎链球菌抗菌作用明显增强,被誉为“呼吸”喹诺酮类。本文对这类药物的抗菌作用、药效学特点、安全性和与其他药物相互作用等加以综述,旨在探讨其在呼吸系统感染中的治疗地位及安全性。
  • 论著
    Lu Meihua
    . 2008, 10(4): 0-0.

    Objective: To study the effects of insulin aspart and human regular insulin on blood glucose in elderly type 2 diabetic patients with irregular food intake. Methods: Thirtythree elderly patients with type 2 diabetes mellitus \[18 men, 15 women, average age (65.82±2.85) years\] were enrolled in a clinical study from February 2006 to April 2007. They initially received regimen A (SC human regular insulin 30 minutes before each meal and SC human isophane insulin at bedtime for 4 months), followed by regimen B (SC insulin aspart 1015 minutes after meals and SC human isophane insulin at bedtime for 4 months). The fasting and 2hour postprandial (after breakfast, midday meal, and evening meal) blood glucose levels were measured twice a week. The frequency and severity of hypoglycemia as well as the changes in glycosylated haemoglobin (HbAlc) levels were observed comparatively between the two regimens. Results: The fasting and 2hour postprandial (after breakfast, midday meal, and evening meal) blood glucose levels were (7.37±4.22) mmol/L, (9.73±3.38) mmol/L, (10.23±3.96) mmol/L, and (10.85±3.36) mmol/L for regimen A, and (701±1.74) mmol/L, (9.23±1.58) mmol/L, (9.22±1.28) mmol/L, and (9.76±1.32) mmol/L for regimen B, respectively. The differences were statistically significant (all P<0.01). The fluctuations of postprandial blood glucose were lower for regimen B than for regimen A. The difference values of HbAlc before and after treatment was (3.08±0.96)% for regimen A and (3.37±0.47)% for regimen B (P<0.01), respectively. The frequency of hypoglycemia and the incidence of moderate-to-severe hypoglycemia were 68 cases and 36.70% for regimen A, and 21 cases and 19.05% for regimen B, respectively. The differences were statistically significant (P<0.001). Conclusion: In elderly type 2 diabetic patients, subcutaneous injection of insulin aspart after meals can effectively decrease the blood glucose levels, reduce the fluctuation of postprandial blood glucose levels, and diminish the frequency and severity of hypoglycemia. It is a safe and effective regimen for elderly type 2 diabetic patients with irregular food intake.

  • Song Haiqing
    Adverse Drug Reactions Journal. 2022, 24(9): 449-453. https://doi.org/10.3760/cma.j.cn114015-20220915-00848
    The theme of World Patient Safety Day 2022 is Medication Safety. Medication safety has become a hot issue in the field of life science research, and the adverse effects of drugs on the central nervous system have gradually attracted clinical attention. Common drug-induced neurological disorders include drug-induced epilepsy, drug-induced extrapyramidal disorders, drug-induced encephalopathy, drug-induced stroke, drug-induced visual impairment, drug-induced spinal cord injury, drug-induced sleep disorders, drug-induced cognitive dysfunction, drug-induced serotonin syndrome, and drug-induced peripheral neuropathy. The drugs that cause drug-induced neurological disorders mainly include antipsychotic drugs, antianxiety and antidepression drugs, anticonvulsant drugs, chemotherapy drugs, and some drugs for cardiovascular system diseases such as statins. The principles for treatment of suspected drug-induced neurological disorders include: (1) improving examination and clarifing diagnosis; (2) removing the causes and stopping or reducing the use of pathogenic drugs; (3) eliminating pathogenic drugs in the body; (4) giving symptomatic treatments and nutritional support.
  • 综述
    . 2004, 6(5): 289-293.
    氟喹诺酮类药物不同品种间安全性存在着明显差别,如曲伐沙星的中枢神经系统反应和肝脏毒性;司帕沙星和格帕沙星对心血管的影响;培氟沙星引发的肌腱损伤;替马沙星与严重的溶血性尿毒症有关;司帕沙星和洛美沙星引起的严重光毒性;克林沙星可引起光毒性和血糖过低;左氧氟沙星的安全性相对较高,不良反应中以胃肠道症状多见。我们就其不同品种间的不良反应差异问题进行文献复习与综述,旨在提高该类药物应用的安全性,减少不良反应的发生。
  • Zhang Xuelan, Zhang Xia
    . 2016, 18(2): 132.
    Oxaliplatin is commonly used in treatment or adjuvant therapy of metastatic colorectal cancer. Oxaliplatin-induced peripheral neuropathy is a sensory neuropathy characterized by peripheral neuritis with dose-limiting and dose-dependent manner. The incidence of acute oxaliplatin-induced peripheral neuropathy is 86% to 95% and its occurrence is related to the oxalate which is one of oxaliplatin metabolites in the body. The clinical manifestations are mainly reversible extremities paresthesia and dysesthesia induced or exacerbated by the cold stimulation. Oxaliplatin-induced chronic peripheral neuropathy, with accumulative and reversible manner, may be related to the drug-induced nerve cell damage and the change of pain signal modulation and transmission, and its incidence rate is dose-related. The clinical manifestations include peripheral sensory function decrease or absence, upper and lower extremity numbness, and even physical dysfunction. The neurotoxicity of oxaliplatin can be prevented or reduced by the avoidance of the cold stimulation during treatment, appropriate extension of the drug infusion period and the application of certain drugs.
  • . 2015, 17(3): 237.
  • 病例报告
    Jiang Qingweia;Li Jianb;Chen Shuchangc
    . 2009, 11(1): 47-3.
    A 73yearold man received a prolonged treatment with warfarin after undergoing mitral valve replacement, and his international normalized ratio(INR) was maintained between 2.0~3.0. The patient received capecitabine chemotherapy due to stomach cancer. During the second cycle of the chemotherapy, he developed hemorrhagic blisters on his feet, nose bleeding, ecchymoses on his buttock, melena, and gross hematuria, and his INR increased. Warfarin was withdrawn immediately. Bleeding stopped after administration of fresh frozen plasma replacement and vitamin K1. The INR was maintained between 1.5~2.5 after the dosages of warfarin and capecitabine were decreased, and the chemotherapy continued and no further bleeding occurred. The increased anticoagulant effect of warfarin may be associated with the capecitabineinduced suppression of cytochrome P450 2C9 isoenzyme. A review of the literature indicates bleeding occurring in patient receiving warfarin plus capecitabine usually is within 2~6 weeks after initiation of the combined chemotherapy. The most common hemorrhage is gastrointestinal bleeding. In order to avoid bleeding occurring, prothrombin time (PT) and INR should be closely monitored, and the dosage of warfarin should be individualized.
  • 监测简报
    . 2004, 6(3): 189-191.
  • Gai Di, Liu Chen, Yan Suying, Wang Yuqin
    . 2016, 18(1): 41.
    Acute kidney injury (AKI) is a common clinical critical illness. Several foreign studies showed that patients with drug-induced AKI accounted for 15%-27% of patients with AKI occurred during hospitalization and a domestic research showed that the proportion was 28.9%. The evaluation methods of causality assessment between drugs and AKI are experts judgement or global introspection, Karch & Lasagnar evaluation method, recommended standard for ADR monitoring center of Health Planning Commission of China, and Naranjo Adverse Drug Reaction Probability Scale(NADRPS), etc. The etiology of drug-induced AKI can be divided into 3 categories, including prerenal, renal, and postrenal. Predisposing factors include advanced age, diabetes, hypertension, chronic kidney disease, low serum albumin, etc. Prevention measures are avoiding and correcting all kinds of risk factors, selecting drugs of low toxicity or no toxicity to kidney, and if necessary early dialysis treatment should be given. Development and improvement of computer aided automatic alert system is very important in prevention, early diagnosis and early treatment of AKI.
  • 综述
    Dai Ning;Ma Qing;Chen Haiping
    . 2014, 16(2): 107-4.

    Wide use of loop diuretics in patients with cardio-renal syndrome may cause loop diuretic resistance, that means the patients′reactions to loop diuretics decline. The mechanisms of loop diuretic resistance are the decrease of renal perfusion, the changes of kidney structure, the excessive activation of neurohormones, the abnormal reaction of tubule-glomerular feedback, sodium retention after diuretic therapy, and hypoproteinemia. Treatment principles for loop diuretic resistance are avoidance of excessive diuretic therapy, continuous and constant infusion of loop diuretics, combined use of drugs to increase renal blood flow, angiotensin converting enzyme inhibitors or angiotensin receptor blockers, positive correction for hypoproteinemia, combined use of different diuretics, application of new diuretics, and blood purification, etc.

  • ADR监测
    . 1999, 1(1): 41-44.
    药物警戒中志愿报告体系的内容,包括数据的收集、评价、解释等。主要目标是提供以往未知的或是重要的药物不良反应的信息。对其中个例报告的评价分两步:先是逐份评价,再集中评价。个例报告的不确定性是志愿报告体系的固有缺陷。因果评价因而已成为各国药物警戒中心的一项常规工作。但至今尚无一种可靠的因果评价方法能消除不确定性,或是对其定量,因此,因果评价的科学价值有限。现有的因果评价方法都是用于所有不良反应和所有药物的一般性方法,与千差万别的药物引起的千变万化的不良反应不相适应。流行病学认为,一般不能从个例报告得出因果关系,现有的各种药品不良反应因果评价标准并不能改变这一结论。
  • 安全用药
    . 2003, 5(4): 245-247.
    黄热病减毒活疫苗是由减毒17D毒种生产而成,具有良好的安全记录,但近年来美国和澳大利亚等国报道的由接种黄热病疫苗所致的嗜内脏毒性和嗜神经毒性的严重不良反应较多,甚至导致患者死亡事件的发生。引起世界各地药品管理当局的高度重视,我国每年使用黄热病减毒活疫苗(17D株)10多万人次,同样存在潜在危险。应引起有关部门特别关注。
  • Zhao Yanyan, Zhang Huixian, Meng Luhua, Feng Jianbo
    Adverse Drug Reactions Journal. 2022, 24(8): 424-429. https://doi.org/10.3760/cma.j.cn114015-20220207-00099
    Objective To explore the risk of cholangitis induced by different immune checkpoint inhibitors (ICIs). Methods Through the OpenVigil data platform, adverse event (AE) reports related to nivolumab, pembrolizumab, cemiplimab, avelumab, durvalumab, atezolizumab, ipilimumab, and tremelimu- mab from the first quarter of 2011 to the third quarter of 2021 in the US FDA Adverse Event Reporting System (FAERS) database were collected. Risk signal mining for cholangitis was performed using reported odds ratio (ROR) method. The detection threshold of the risk signal was set as that the number of AE reports was greater than or equal to 3 and the lower limit of the 95% confidence interval (CI) of the ROR was greater than 1. The higher the ROR and its 95%CI lower limit, the stronger the signal intensity. The intensity of the risk signal of cholangitis due to different ICIs was compared and the main characteristics (sex, age, type of primary tumor, time of occurrence of AE, and outcome) of patients with ICIs-related cholangitis were analyzed descriptively. Results A total of 52-440 AE reports related to the above 8 ICIs were collected, of which 410 cases were about cholangitis. The drugs that were detected with positive risk signals were nivolumab, pembrolizumab, atezolizumab, durvalumab monotherapy, and ipilimumab combined with nivolumab. Their number of AE reports were 213, 107, 48, 5, and 29 (402 patients in total), and the corresponding ROR (lower limit of 95%CI) were 37.88 (32.89), 26.07 (21.46), 32.12 (24.10), 13.63 (5.65), and 14.46 (10.02), respectively. The risk signal intensity was nivolumab, atezolizumab, pembrolizumab, ipilimu- mab combined with nivolumab, and durvalumab in order. Seeing from the available data among the reports, males were more than females (233∶110=2.1∶1), 55.2% (222/402) of patients were 65 years old and over, and 48.0% (193/402) of patients were non-small cell lung cancer. ICIs-related cholangitis could result in hospitalization or prolongation of hospitalization in 42.3% (170/402), requiring emergency treatment in 40.0% (161/402), life-threatening in 2.0% (8/402), and death in 15.7% (63/402) of patients. Conclusions The risk of cholangitis induced by ICIs is different and the risk signal of nivolumab is the strongest. Cholangitis is a serious AE of ICI, which should attract clinical attention.
  • Wang Xinyu, Yu Hui, Yang Zhiyan, Zhang Yundi, Li Yue, Li Yan
    Adverse Drug Reactions Journal. 2023, 25(4): 237-242. https://doi.org/10.3760/cma.j.cn114015-20220816-00751
    Objective To explore the risks of medication errors of insulin degludec(IDeg) in clinical application using failure mode and effect analysis (FMEA). Methods A research group on the risk points of medication errors was established in the First Affiliated Hospital of Shandong First Medical University. The risk points of medication errors were collected through questionnaire survey, literature research, and on-the-spot investigation. The severity, frequency of occurrence, and likelihood of detection were scored to determine the risk priority number (RPN) and formulate corresponding preventive measures. Results After comprehensive evaluation, 32 risk points were found in the 4 links of physician prescription, pharmacist dispensing, nurse administration, and patient medication. The RPN was ranked from high to low, and 10 key risk points (RPN>70 points) were selected. (1)The pharmacist did not give the patients guidance on the use of IDeg; (2)Patients did not know that they should actively report to the physicians about the use feeling and adverse reactions of the drug; (3)Patients did not clear about the content of medication monito- ring; (4)Patients did not master how to use the drug; (5)Pharmacists did not conduct medication feedback survey on patients; (6)Patients did not attach importance or thought it was unnecessary to receive medication guidance from pharmacists; (7)Physician′s prescription was wrong, resulting in overdose; (8)Doctors and patients did not communicate well, and patients did not know what medicine they were using; (9)Pharmacists did not fully understand drug information such as drug properties, prohibited population, interaction, medication time, etc.; (10)Pharmacists ignored the commonly used dose of the drug, applicable population, and other information in the process of reviewing the prescription. According to above-mentioned risk points, the risk intervention suggestions of IDeg were put forward, including the maintenance of basic drug information, the prescription of doctors, the dispensing of pharmacists, the patient medication link, the nurse administration link, the collection of medication error reports, and the strengthening of personnel training. Conclusion The FMEA method can be used to effectively find out the risk points of medication errors in the clinical application of IDeg, the priority of IDeg risk management can be determined through quantitative evaluation, and corresponding preventive measures can be formulated.
  • 综述
    . 2005, 7(1): 1-4.
    肾素-血管紧张素系统(RAS)参与动脉粥样硬化的发病过程,血管紧张素II(AngII)是诱发或加重动脉粥样硬化的重要因素。AT1(AngII)受体拮抗剂通过恢复和维持血管内皮功能,增强纤维蛋白溶解,防止低密度脂蛋白的氧化修饰等作用,在抗动脉粥样硬化进程中发挥重要作用,有着广阔的临床应用前景。
  • 安全合理用药
    Shi Guiying
    . 2007, 9(5): 332-334.
    Thalidomide was withdrawn from the market in the early 1960s after it was discovered that it produced teratogenic effects.Despite its withdrawal from market,thalidomide research did not discontinued.In the mid-1960s,it was found that thalidomide was an effective treatment for erythema nodosum leprosum;therefore,it was reintroduced to clinical practice.Since then,thalidomide has been used in several other diseases.However,serious adverse reactions,such as peripheral neuropathy,thrombosis,cytopenia,and hapatoxicity,occurred in thalidomide treatment.Understanding these adverse reactions no doubt is helpful to safe use of thalidomide.
  • Li Xiaoli, Wu Kunrong, Yin Ying, Li Rui, Zhang Shufang, Guan Ziwan, Li Yan
    Adverse Drug Reactions Journal. 2020, 22(4): 239-246. https://doi.org/10.3760/cma.j.cn114015-20190327-00292
    Objective To explore the risk factors of myelosuppression caused by nedaplatin in patients with lung cancer. Methods The medical records of postoperative patients with advanced lung cancer and receiving nedaplatin-based chemotherapy in Shandong Provincial Qianfoshan Hospital from June 2015 to August 2018 were searched using hospital information system and analyzed retrospectively. Accor- ding to sex, age (<60 years old, ≥ 60 years old), glutathione mercaptotransferase (GSTP) 1A313G genotype (AA or AG), pathological classification (non-small cell lung cancer, small cell lung cancer), having smoking history or not, being with or without liver injury and kidney injury, the patients were divided into 2 groups, respectively. The overall myelosuppression incidence and incidences of myelosuppression with different manifestations and different degrees were compared respectively between each 2 groups of patients with above-mentioned 7 different clinical features. The risk factors of nedaplatin-induced myelosuppression were analyzed using logistic regression. Results A total of 46 patients were enrolled, including 34 males and 12 females. Among the 46 patients, 30 cases developed myelosuppression after administration of nedaplatin, and the overall incidence of myelosuppression was 65.2%, including 20 cases of grade Ⅰ-Ⅱ (43.5%) and 10 cases of grade Ⅲ-Ⅳ (21.7%). After administration of nedaplatin, the incidence of severe myelosuppression in patients with small cell lung cancer (3/5)was higher than that with non-small cell lung cancer (17.1%) (P<0.05), showed by the univariate analysis; the overall incidence of leukopenia in males was higher than that in females (58.8% vs. 25.0%); the overall incidence of leukopenia and neutropenia was higher in patients with smoking history than that in patients without previous smoking history (68.0% vs. 28.6%, 0.01%, P=0.01; 64.0% vs. 33.3%, P=0.04); the overall incidence of thrombocytopenia in patients with small cell lung cancer was higher than that with non-small cell lung cancer (4/5 vs. 9.8%, P<0.01); the differences in the incidences of different degrees of neutropenia in patients with and without smoking history were statistically significant (P=0.03); the differences in the incidences of different degrees of leukopenia, neutropenia, and thrombocytopenia in patients with different pathological classification were statistically significant (P<0.01 for all). The binary logistic regression analysis showed that the risk of thrombocytopenia in patients with small cell lung cancer was higher than that with non-small cell lung cancer (OR=25.00, 95%CI:2.20-284.61, P=0.01). The orderial logistic regression analysis showed that a pathological classification of small cell lung cancer was a risk factor for severe myelosuppression, leukopenia, neutropenia, and thrombocytopenia(OR=13.20, 95%CI: -4.67-0.49, P=0.02; OR=22.20, 95%CI: -5.37-0.83, P=0.01; OR=19.49, 95%CI: -5.11- 0.82, P=0.01; OR=13.87, 95%CI: -4.89-0.38, P=0.02). Conclusions A pathological classification of small cell lung cancer is an independent risk factor for severe myelosuppression in lung cancer patients after taking nedaplatin. Male patients with a history of smoking are more likely to have leukopenia/neutropenia.
  • 病例报告
    Zhang Wei;Liu Xiujin
    . 2008, 10(6): 0-0.
    A 68yearold woman with pulmonary tuberculosis was administered with IV rifamycin 0.5 g once daily, oral isoniazid 0.3 g once daily, and oral ethambutol 0.5 g thrice daily. Her routine blood tests were normal (WBC count 4.91×109/L, neutrophils 0.729) before therapy. After 12 days of therapy, her WBC count and neutrophils decreased to 2.48×109/ L and 0.557, respectively. Leucopenia and neutropenia were considered to be possibly rifamycinrelated. rifamycin was discontinued. Seven days later, the woman’s WBC count and neutrophils returned to within normal limits (4.41×109/L and 0.622, respectively). IV rifamycin 0.5 g once daily was restarted. Seven days later, her WBC count and neutrophils decreased to 2.93×109/L and 0.487, respectively. rifamycin was withdrawn again and switched to IV levofloxacin 0.2 g twice daily. Isoniazid and ethambutol were continued. Ten days later, her routine blood tests were normal.
  • 药物警戒
    . 2002, 4(2): 87-90.
    本文概述国际药物不良反应数据库的发展情况。WHO乌普萨拉监测中心负责国际药物监测的技术工作,该中心收集60个国家药物监测中心疑为药物不良反应的报告,每年共约15万份,目前该数据库已累积200余万份报告。为适应现有的和未来的用户需求,新系统按数据字段(data fields)和功能性(functionality)设计。新的数据库有无限量的数据字段,WHO药物监测系统以及时、安全方式传递、存储和检索信息,并通过完善的服务器技术,保证国际互联网(Internet)可以安全传递数据和文档。
  • 安全用药
    . 2006, 8(6): 431-433.
    贝伐单抗(Bevacizumab,Avastin)是一种重组的血管内皮生长因子单克隆抗体,是首个批准上市的血管内皮生长因子(VEGF)抑制剂。通过抑制能够刺激新血管形成的VEGF,使肿瘤组织无法获得所需的血液、氧和其他养分而最终″饿死″,达到抑制肿瘤生长和转移的功效。于2004年2月26日,美国食品和药物管理局(FDA)批准贝伐单抗联合5-Fu化疗方案用于治疗晚期结直肠癌的一线药物,贝伐单抗单药治疗的有效率为15%-20%,与化疗联合应用的有效率为30%-50%。贝伐单抗及与化疗方案联用的常见不良反应包括高血压、出血、血栓形成、蛋白尿、心脏毒性等,严重罕见的不良反应有胃肠道穿孔、伤口愈合并发症等。贝伐单抗单药使用的不良反应程度轻微,联用后贝伐单抗并不增加化疗方案的毒副作用,多数患者耐受良好。
  • Yu Liping, Peng Xiangjun, Chen Jie, Wang Ping, Zhang
    Adverse Drug Reactions Journal. 2022, 24(2): 92-93. https://doi.org/10.3760/cma.j.cn114015-20210311-00292
    A 75-year-old female patient underwent total thyroidectomy and neck lymph node dissection for thyroid malignant tumor. In order to supplement thyroid hormone after operation, the patient was given levothyroxine sodium tablets 100-μg by nasal feeding once daily. On the 5th day of treatment, the patient developed fever, with highest body temperature 39.0-℃. The levothyroxine sodium were stopped, then her body temperature decreased to 36.2 ℃ the following day. After giving nasal feeding of levothyroxine sodium tablets again or oral levothyroxine sodium tablets produced by other manufacturers, fever recurred in the patient and the body temperature returned to normal after drug withdrawal. It was considered that the patient′s fever was drug fever caused by levothyroxine sodium tablets.
  • Xiao Guirong, Zhang Weidong, Liu Yixian, Fan Ping, Hu Ming, Xu Ting
    Adverse Drug Reactions Journal. 2021, 23(11): 570-576. https://doi.org/10.3760/cma.j.cn114015-20210407-00425
    Objective To explore the effect of clinical pharmacists′ intervention in therapeutic drug monitoring (TDM) of voriconazole on medication safety. Methods The study subjects were inpatients with fungal infection, admitted from January 2019 to June 2020 in the Department of Infectious Diseases, West China Hospital, Sichuan University, who were scheduled to be treated with voriconazole. Using random-cluster method, patients were divided into intervention group and control group based on their doctor medical groups. In the intervention group, clinical pharmacists participated in the whole process of voricona- zole TDM and provided pharmaceutical care, while in the control group, no clinical pharmacists participated in TDM. The percentage of voriconazole-treated patients achieved target trough concentration(1.5-5.5-mg/L), the incidence of adverse reactions, and clinical cure rate between the 2 groups were compared. The timely (within 24-hours) management rate of medication orders containing drugs with interaction by doctors and the detection frequency of blood drug concentration were compared between the 2 groups. Results A total of 303 patients were enrolled in the analysis, including 166 in the intervention group and 137 in the control group. There was no significant difference between the 2 groups in demographic characteristics, liver function indexes, types of fungal diseases, main combined diseases, and the use of drugs with interactions with voriconazole before voriconazole treatment (all P>0.05). After receiving voriconazole, percentage of patients achieved target trough concentration in the intervention group was similar to that in the control group in the first detection [55% (91/166) vs. 50% (69/137), P=0.440] while significantly higher in the last detection[81% (134/166) vs. 47% (65/137), P<0.001]. The total frequency of trough concentration detection in the intervention group and the control group were 403 and 244 respectively. Percentage of detection values consisted with target trough concentration was significantly higher, while percentage of detection values exceeding target trough concentration (>5.5-mg/L) was significantly lower in the intervention group than those in the control group, respectively [63% (254/403) vs. 44% (107/244), P<0.001; 19% (63/403) vs. 22% (54/244), P=0.037)]. The total incidence of voriconazole-related adverse reactions [14% (23/166) vs. 23% (31/137)], the incidence of severe adverse reactions [2% (4/166) vs. 8% (11/137)], and incidence of liver injury [Council for International Organizations of Medical Sciences standard: 8% (13/166) vs. 15% (21/137); International Drug-induced Liver Injury Expert Working Group standard: 2% (4/166) vs. 7% (10/137)] in the intervention group were significantly lower than those in the control group (all P<0.05), and the clinical cure rate was similar in the 2 groups [86% (142/166) vs. 81% (111/137), P=0.291]. In the intervention and control groups, some patients were using drugs which had interactions with voriconazole when starting voriconazole treatment, and the timely management rates of these medication orders were 71% (24/17) and 18% (3/17) respectively, with a statistically significant difference between the 2 groups (P=0.001). The detection frequency of voriconazole trough concentration in the intervention group (2.4 times per patient) was higher than that in the control group (1.8 times per patient), and the proportion of patients with ≥3 detection was significantly higher [38% (63/166) vs. 23% (32/137), P=0.006]. Conclusion The involvement of clinical pharmacists in voriconazole TDM can enlarge the percentage of patients who achieve target trough concentration, improve the timely management rate of medication orders containing drugs with interactions with voriconazole, reduce the incidence of voriconazole-related adverse reactions, and improve medication safety.
  • Song Zhihui, Li Quanzhi, Ji Liwei, Tang Yan, Zeng Yan, Zhen Jiancun
    Adverse Drug Reactions Journal. 2022, 24(11): 571-577. https://doi.org/10.3760/cma.j.cn114015-20220915-00844
    Objective To understand the status quo and problems of insulin application at home in patients with diabetes mellitus. Methods Pharmacists in many hospitals across the country were organized to conduct a questionnaire survey on status quo of insulin application in patients with diabetic mellitus, so as to understand their insulin use, insulin injection behavior, insulin treatment adherence, glucose monitoring adherence, insulin preservation behavior, rate of up to target blood glucose, and the incidence of adverse reactions such as hypoglycemia. The questionnaire contained 50 questions, the accuracy rate of 21 questions related to insulin application norms was calculated, and the effect of insulin application behavior of patients on the efficacy and safety of insulin therapy was investigated. Results Clinical pharmacists from 31-hospitals across the country participated in the questionnaire distribution and survey, and 240 valid questionnaires were returned. Among the 240 patients, 106 (44.2%) were male and 134 (55.8%) were female, aged (58±15) years; 210 (87.5%) had type 2 diabetes mellitus, 25 (10.4%) had type 1 diabetes mellitus, and 5 (2.1%) had other types; 151 (62.9%) patients were treated with one kind of insulin, 89 (37.1%) were treated with 2 kinds of insulin, and a total of 13 kinds of insulin were involved; 97.9% (235/240) of the patients had at least one wrong or irregular insulin use behavior, 75.0% (180/240) had at least one problem related to insulin treatment adherence, 70.4% (169/240) had poor glucose monitoring adherence, and 68.8% (165/240) had at least one irregular insulin preservation behavior. The rate of up to target blood glucose was only 13.8% (33/240), and the incidence of hypoglycemia was 55.8% (134/240). The total correct rates of answers to insulin use behavior and treatment adherence in patients with up to target blood glucose were significantly higher than those in patients without up to target blood glucose [71.4% (57.1%, 81.0%) vs. 61.9% (52.4%, 71.4%), P=0.045; 77.8% (55.6%, 88.9%) vs. 66.7% (55.6%, 77.8%), P=0.023], and differences in the correct rate of answers to insulin use behavior and each behavior between the patients with and without hypoglycemia were not statistically significant (all P>0.05). Conclusions Insulin has a wide variety and similar drug names, which are easily confused, leading to medication errors. The incidence of irregular insulin injection behavior, treatment adherence, and insulin preservation behavior in patients is high, which may affect the rate of up to target blood glucose.
  • 调查研究
    Chen Yan①;Dun Zhe②;Wu Ye③;Deng Peiyuan④;Cao Liya③;Wang Mei⑤;Zhan Siyan①
    . 2004, 6(5): 300-303.
    Objective: To investigate ADR knowledge among health professionals(HP) at Haidian district in Beijing. Methods: By cluster sampling, a questionnaire survey was conducted in 947 subjects of 17 hospitals. Results: 44.9 percent of all subjects showed that they knew clearly the adverse reactions to the drugs they ever used, and over 60% of subjects could pass a right judgment on ADR. Most of HP believed that the ADR reporting should be necessary and practicable. HP aged 35-45 had richer knowledge of ADR than other age groups (x2=21.73,P<0.05). The scores of ADR knowledge were significantly different among the HP in hospitals at different rating (x2=11.68,p<0.05). Conclusion: It is now urgent to provide more training courses for HP in order to elevate their levels of ADR knowledge.
  • 专题讲座
    . 2005, 7(1): 51-54.
  • 中毒救治
    . 2006, 8(3): 202-204.
    钩吻是毒性极强的外用中药,应用不当或误服可致中毒,有时还可致命。主要毒性成分是钩吻碱,以钩吻素子含量最高。钩吻中毒主要抑制延髓呼吸中枢,并抑制脑和脊髓的运动中枢。临床表现以呼吸系统、神经系统症状为主,可出现呼吸衰竭和呼吸肌麻痹,是钩吻中毒最常见的死因。目前尚无特效解毒剂,以对症支持治疗为主。洗胃时须注意监测呼吸情况,必要时先行气管插管再洗胃。
  • Zuo Yihui1, Edward Lee2, Hu Weiping1, Ye Xiaofen3, Zhang Jing1
    Adverse Drug Reactions Journal. 2020, 22(2): 77-84. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.005
    Objective To explore the occurrence of hepatic injury related to amphotericin B and analyze its influencing factors. Methods The medical records of inpatients, who received amphoteric B during hospitalization and had complete records of liver function before and after medication, were searched from the Hospital Information System of Zhongshan Hospital, Fudan University from January 2013 to December 2017 and analyzed retrospectively. Liver injury was classified and diagnosed according to the Guidelines for the diagnosis and treatment of drug-induced liver injury and its incidence was calculated. According to the age (≤45 or >45 years old), with or without history of liver injury/liver disease within 3 months before admission, the dosage form of amphotericin B (non-liposome or liposome), the maximum daily dose (<30 or ≥30 mg), the maximum daily dose/body weight (<0.5 or ≥0.5 mg/kg), with or without step-up dosage, the course of treatment (≤21 or >21 d), the cumulative dose (<600 or ≥600 mg), cumulative dose/body mass (<10 or ≥10 mg/kg), with or without combination use of liver-protective drugs, and with or without combination use of other drugs with hepatotoxicity, the patients were divided into 2 groups, respectively. The levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil), alkaline phosphatase (ALP), and gamma-glutamyltransferase (γ-GT) were compared respectively in patients in each 2 groups with above-mentioned 11 different clinical features. The influencing factors of hepatic injury related to amphotericin B were analyzed using multivariate logistic regression analysis and multiple linear regression analysis, whose effect values were expressed as odds ratio (OR) with 95% confidence interval (CI) and standardized regression coefficient with 95%CI and value of R2. Results A total of 42 patients were enrolled, including 31 males and 11 females with ages from 13 to 92 years old and body mass (65.0±12.3)kg. Of the 42 patients, 26 patients were ≥45 years old; 15 patients had history of hepatic injury/liver disease; 30 patients used amphotericin B, 10 used amphotericin B liposome, and 2 used both of them; 25 patients received the maximum daily dose of amphotericin B <30 mg and the maximum daily dose/body mass <0.5 mg/kg, 17 patients had the maximum daily dose ≥30 mg and the maximum daily dose/body mass ≥0.5 mg/kg; 28 patients used amphptericin B with step-up dosage, 14 patients′ initial doses were the maximum daily dose; 24 patients′ cumulative dose of amphotericin B and the cumulative dose/body mass were <600 mg and <10 mg/kg, respectively, while 18 patients′ cumulative dose of amphotericin B and the cumulative dose/body mass were ≥600 mg and 10 mg/kg, respectively; 29 patients received combination use of hepato-protective drugs; 33 patients received combination use of other hepatotoxic drugs. The levels of TBil and ALT in 42 patients after amphotericin B treatment were obviously higher than those before medication (P=0.019, P=0.017). Seven patients were diagnosed as drug-induced liver injury, the incidence of drug-induced liver injury was 16.7%. The result of multivariate logistic regression analysis showed that history of hepatic injury/liver disease within 3 months before admission was the independent risk factor for elevated γ-GT level after medication (OR=2.029, 95%CI:1.037-3.970, P=0.039). The results of multiple linear regression analysis showed that the maximum daily dose ≥30 mg and the cumulative dose ≥600 mg were the independent risk factors for elevated TBil level after medication (standardized regression coefficient: 0.59, 95%CI: 0.28-0.90, P=0.001; standardized regression coefficient:1.61, 95%CI: 0.14-3.07, P=0.033; R2=0.524); hepatic injury/liver disease within 3 months before admission was the independent risk factor for elevated ALP and γ-GT levels after medication (standardized regression coefficient: 0.85, 95%CI: 0.25-1.45, P=0.006, R2=0.205; standardized regression coefficient: 0.89, 95%CI: 0.29-1.50, P=0.005, R2=0.206). Conclusions The incidence of liver injury related to amphotericin B in Zhongshan Hospital, Fudan University is 16.7%. The maximum daily dose of amphotericin B ≥30 mg and cumulative dose ≥600 mg are the independent risk factors for the elevated level of TBil, history of hepatic injury/liver disease within 3 months before admission is the independent risk factors for elevated levels of ALP and γ-GT.
  • 期刊评价
    . 2008, 10(3): 225-4.

    目的:科学、客观地评估《药物不良反应杂志》的质量。方法:运用文献计量学方法,统计分析2003-2007年《药物不良反应杂志》刊文量、刊文内容、作者信息、引用参考文献量和主要评价指标。结果:该刊30期共刊登学术论文1 228篇,专门报道药物不良反应和安全用药,学术性、实用性强;作者群在不断扩大,遍及全国31个省、市和自治区;论文合著率较高,为7158%;引用参考文献5 706篇,篇均4.65篇;主要评价指标上升幅度较大,影响因子呈快速上升趋势。在2005-2007年版《中国期刊引证报告》、《中国学术期刊综合引证报告》、《中国科技期刊引证报告》中,其影响因子均居药学期刊前列,2007年版分别为1.591,1.498和0.935,均居药学期刊首位。结论:《药物不良反应杂志》是具有鲜明特色的药学专业性学术刊物,其质量和影响力提高显著,对我国药学学科的发展、提高临床安全用药水平和促进药物安全信息的交流具有积极推动作用。

  • 病例报告
    Chen Guimei
    . 2008, 10(4): 0-0.
    A 1.5yearold boy was hospitalized with chill and fever after an IV infusion of ceftriaxone sodium 1.0 g for upper respiratory tract infection. On admission, he appeared listlessness and sallow. Routine blood tests revealed the following: Hb 92 g/L, RBC 4.21×1012/L, MCV 68.4 fl, PCV 0.288, and Ret 0.01. On day 2 after admission, he was given an IV infusion of ceftriaxone 10 g dissolved in 100 ml of glucose 5% again. Five hours later, he developed yellowish of the skin, and further 2 hours later, dark urine and temperature of 39 ℃ occurred. Laboratory testing showed the following: Hb 45 g/L, RBC 1.83×1012/L,PCV 0.12, Ret 0.03, and a positive direct Coombs test. Acute hemolytic anemia was diagnosed. Ceftriaxone sodium was stopped immediately. He was treated with IV dexamathasone, IV immunoglobulin, and a red cell transfusion. His symptoms were relieved, and laboratory testing showed the following: RBC 3.60×1012/L,Hb 91 g/L,PCV 0.289, and Ret 0.036.
  • 安全用药
    . 2002, 4(6): 382-383.
  • Liu Xiaoman, Chen Xiao
    Adverse Drug Reactions Journal. 2022, 24(10): 505-507. https://doi.org/10.3760/cma.j.cn114015-20220812-00736
    Immunosuppressants can be used to treat a variety of pediatric diseases. However, at present, the information on children′s drug use in drug labels are insufficient, the drug specifications and dosage forms are lacking, and off-label prescribing is more common. The pathophysiological status and drug metabolism characteristics in children are obviously different from those in adults, and the immune system is not yet mature, so the risk in drug use is higher than that in adults. It is necessary to find a balance between insufficient and excessive immunosuppression. However, it is difficult for infants to feed drugs, and children and adolescents have poor treatment compliance in the absence of guardian management, which may lead to reduced efficacy or treatment failure. It is necessary to strengthen the monitoring of adverse reactions and treatment drug monitoring of immunosuppressants therapy in children, and carry out research on pharmacogenomics to ensure the safety of immunosuppressants in children from multiple dimensions.
  • 安全用药
    . 2004, 6(4): 240-243.
    肾毒性是传统抗炎药和特异性环氧合酶-2抑制剂最常见的不良反应,其发生率为3%~5%。肾毒性表现有末梢水肿、急性肾衰、间质性肾炎、肾病综合征及肾乳头坏死等,轻者停药可恢复,少数患者可致死。非甾体抗炎药所致肾毒性可见于肾功能正常者,及高危人群,如已有肾病变、心衰、肝病、服利尿剂或ACE抑制剂及老年患者。对接受非甾体抗炎药治疗的患者,在治疗前和治疗中都应密切监测尿常规和肾功能指标。
  • Chen Wenwen, Jiang Yongxian, Tao Wanjun, Yangjia, Li Gen
    Adverse Drug Reactions Journal. 2021, 23(1): 35-38. https://doi.org/10.3760/cma.j.cn114015-20200714-00770
    A 4-month and 19-day-old girl with a body weight of 4.4-kg was treated with 5% digoxin oral solution 0.9-ml (0.045-mg) once per 12-hours after repair of ventricular septal and atrial septal defects. Spironolactone, hydrochlorothiazide, and captopril were given at the same time. The blood concentration of digoxin was detected on the 6th day of medication, and the pharmacist found that it was more than 5.0-μg/L, and immediately went to the ward to see the child. The bedside electrocardiograph showed that the baby girl had reduced heart rate (80 beats/min), arrhythmia, third-degree atrioventricular block, complete right bundle- branch block, and ST-T changes. Digoxin poisoning was diagnosed and digoxin was immediately discon- tinued. Three days later, the blood concentration of digoxin decreased to 1.66-μg/L, and her heart rate and electrocardiograph returned to normal. By reviewing the medication information of the baby, a digoxin poisoning event due to overdose of digoxin and drug interactions was diagnosed. Due to the event, the use of digoxin in hospitalized children in the whole hospital from January 2017 to May 2019 was investigated. Among 323 children, 14 children (4.3%) overdosed with digoxin; 235 children (72.8%) were treated with digoxin for more than 5 days, but the detection rate of blood concentration was only 12.8% (30/235); 67.5% children (240/323) were prescribed drugs that might interact with digoxin or increase the risk in digoxin treatment. Through the analysis of risk factors, improvement measures such as optimizing medical order audit system, increasing the monitoring rate of digoxin blood concentration, and strengthening training were put forward, and an expert consensus in the hospital was reached. After implementation of the improvement measures, a total of 47 children were prescribed digoxin in the whole hospital from January to June, 2020, none of them were given overdose of digoxin, and the monitoring rate of digoxin blood concentration was increased to 40.4% (19/47).
  • Li Xiaojuan, Zhang Aiwu
    Adverse Drug Reactions Journal. 2021, 23(5): 273-274. https://doi.org/10.3760/cma.j.cn114015-20201119-01158
    A 46-year-old female patient was treated with Jingangteng capsules 2 g (4 capsules) thrice daily and Kangfuyan capsules 1.2 g (3 capsules) twice daily after hysterectomy. After 23 days of treatments, the patient developed gastrointestinal discomfort, and Jingangteng capsules and Kangfuyan capsules were stopped 2 days later. However, gastrointestinal discomfort gradually worsened and symptoms such as nausea, dark urine, and yellow staining of the skin and sclera appeared. After discontinuing the drug for 10 days, laboratory tests showed alanine aminotransferase (ALT) 366-U/L, aspartate aminotransferase (AST) 485-U/L, alkaline phosphatase (ALP) 145-U/L, gamma glutamyltransferase (γ-GT) 67-U/L, total bilirubin (TBil) 67.1-μmol/L, and direct bilirubin (DBil) 59.5-μmol/L. Viral hepatitis and biliary obstruction were excluded by laboratory tests and imaging examination, and drug-induced liver injury was diagnosed. Oral liver-protective drugs and IV infusions of compound glycyrrhizin injection and polyene phosphatidylcholine injection were given successively, but jaundice continued to deepen with the peak TBil and DBil values of 189.7-μmol/L and 159.4-μmol/L, respectively. An IV infusion of ademetionine 1,4-butanedisulfonate for injection 1 g dissolved in 5% glucose injection 250-ml was given once daily. Three days later, the patient′s symptoms were improved and the jaundice subsided obviously; 9 days later, the liver function was improved obviously and laboratory tests showed ALT 29-U/L, AST 50-U/L, γ-GT 36-U/L, TBil 66.5-μmol/L, and DBil 53.2-μmol/L; 1 month later, her liver function returned to normal.
  • Liu Min, Yi Wei, Cai Haodong
    . 2016, 18(2): 126.
    Tenofovir disoproxil fumarate (TDF) is a nucleotide reverse transcriptase inhibitor used in the treatment of human immunodeficiency virus or hepatitis B virus (HBV) infection. It can effectively reduce the HBV DNA level of chronic HBV infected pregnant women, preventing HBV mother-to-child transmission. TDF has been recommended by the European Society of Liver Disease as drug of choice for HBV infection in pregnant women and designated as class B drug for pregnancy by the United States Food and Drug Administration. No adverse outcome or impact has been observed in current researches on TDF to mothers or fetus or to babies through breast feeding exposure. More in-depth and meticulous researches are needed for the safety of TDF in human pregnancy and lactation.
  • Xu Peng, Zhang Guozhu
    . 2017, 19(1): 17-21.
    ObjectiveTo analyze the prevalence and risk factors of potentially inappropriate medication (PIM) use among elderly inpatients.MethodsThe data of patients  ≥65 years of age and hospitalized in Department of Internal Medicine in the Third People′s Hospital of Hefei from January to December in 2015 were collected and the gender, age, department, diseases that patient suffered from, hospitalization days, drug varieties used in one patient, methods of payment were recorded. The patients were divided into 2 groups: the 65-79 years old group and the  80 years old group. The utilization rate of PIM drugs, the drug varieties, the proportion of PIM use between the patients in the 2 groups were calculated. The risk factors of PIM use was analyzed by Logistic regression method.ResultsA total of 388 patients (their ages were from 65 to 79 years and their average age was (76±7) years were enrolled in this study, including 206 males and 182 females. Of the 388 patients, 278 (71.6%) patients were in the 65-79 years old group and 110 (28.4%) were in the  ≥80 years old group. The utilization rate of PIM drugs was 54.9% (213/388) and the utilization rate of high-risk PIM drugs was 28.6% (111/388). The utilization rate of PIM drugs in the 65-79 years old group was 57.9% (161/278) and 47.3% (52/110) in the ≥80 years old group (χ2=3.604, P=0.058). Among 213 patients receiving PIM drugs, 132 (62.0%) patients were prescribed with one PIM drug, and 56 (26.3%), 17 (8.0%), 6 (2.8%), 2(0.9%) patients were prescribed with 2 to 5 PIM drugs, respectively. Twenty-four PIM drugs were used in the 213 patients and 17 high-risk PIM drugs were used in 111 patients, accounting for 33.3% (24/72) of the total number of PIM drugs and 48.6% (17/35) of the high-risk PIM drugs, respectively. According to the ratio of application, the top 3 drugs were insulin, anticoagulants, sedatives and hypnotics in the 65-79 years old group and anticoagulants, sedatives and hypnotics, and theophylline in the ≥80 years old group. The results of Logistic regression showed that the main risk factors of PIM use were ages (OR=0.531, 95%CI: 0.326-0.865, P=0.011) and prescribed drugs varieties (OR=3.927, 95%CI: 2.678-5.757, P<0.001). ConclusionsThe utilization rate of PIM drugs in elderly inpatients in our hospital was higher. The risk factors of PIM use were patients′ages and drugs varieties.
  • Zeng Jiawei, Chen Xiao
  • 调查研究
    Lu Qingli;Fang Juanjuan
    . 2001, 3(1): 18-21.
    Objective: To find out the present situation of adverse reaction of traditional Chinese medicines. Methods: Reported cases of ADR related to traditional Chinese medicines were collected from Chinese Pharmaceutical Abstracts (1990-1999) and Title List of ADR Literature (1980-1989). Results: 2732 cases of adverse reactions were caused by traditional Chinese medicines and allergy was in the first place of ADR under this survey. Conclusion: Appropriate mesaures should be taken in order to assure the safe use of the drugs.
  • 论著
    Zhou Jueqian;Pan Junli;Chen Shuda;Chen Liujing;Chen Ziyi;Liu Zhonglin;Zhou Liemin
    . 2008, 10(3): 158-5.

    Objective: To analyse risk factors for severe drug eruption induced by carbamazepine in clinical practice in order to decrease its development. Methods: The clinical data of 55 inpatients with carbamazepineinduced drug eruption were collected from 1997 to 2007. Of the 55 patients, 28 were nonsevere eruption and 27 were severe eruption. The relationship between the severe eruption and the age, sex, allergic history, epilepsy, initial dosage of carbamazepine, and latent of eruption was analyzed. Other adverse reactions were compared between the two groups. Results: The relationship between the severity of drug eruption and the age, sex, allergic history, and epilepsy was not found (P>0.05). It was linked to initial dose of carbamazepine and longer latent period of eruption. And there were differences in the initial dosage of carbamazepine and the latent period of eruption between the severe eruption group and the nonsevere eruption group. The initial dosage of carbamazepine was (155.74±81.130) mg/d and (124.11±44.867) mg/d(P<005), respectively. The latent period of eruption was (11.81±7.45) days and (6.14±5.30) days (P<0.01). The severity of liver damage in patients with severe eruption is greater than that in patient with nonsevere eruption (P <0.01). The condition of patients with a fever occurring in the early stage was severe. Conclusion: The high initial dose of carbamazepine and long latent period of eruption may increase the drug eruption intensity.

  • Wang Xinyu, Zhang Yundi, Li Yue, Zong Huiying, Han Wenqian, Liu Lun, Wang Qian, Guo Lubo, Di Huifeng, Zhen Xiaohui, Sun Deqing, Su Ying, Zhang Zonglin, Peng Jing, Cao Xiaofu, Liu Ning, Liu Jian, Lu Cuicui, Wang Li, Geng Tao, Li Rongji, Sun Guodong, Zhang Fan, Zhang Lin, Ma Chuanjiang, Tan Siyuan, Qian Dongfang, Li Yan
    Adverse Drug Reactions Journal. 2023, 25(11): 649-655. https://doi.org/10.3760/cma.j.cn114015-20230706-00505
    Objective To compare the efficacy and safety of insulin degludec and insulin glargine U100 in patients with type 2 diabetes mellitus. Methods This study was a retrospective cohort study. The subjects were patients with type 2 diabetes mellitus who were hospitalized in 13-3A-level general hospitals in Shandong Province from September 2018 to December 2021. According to the type of basal insulin used, the patients were divided into insulin degludec group and insulin glargine U100 group. The basic information and laboratory test results in patients in the 2 groups were collected, the differences of fasting blood glucose level and incidence of hypoglycemia between the 2 groups were compared. The patients with complete blood glucose monitoring data in the 2 groups were selected and their blood glucose fluctuations were compared. Results A total of 1-152 patients were entered in the study, including 552 patients in the insulin degludec group and 600 patients in the insulin glargine U100 group. The difference in the basic conditions in patients in the 2 groups was not statistically significant (all P>0.05). After treatment, the fasting blood glucose levels in patients in the 2 groups were lower than those before treatment, with statistically significant differences [10.2 (8.8, 12.5) mmol/L vs. 7.5 (6.6, 8.7) mmol/L, Z=-19.443, P<0.001; 10.0 (8.6, 11.7) mmol/L vs. 7.8 (6.6, 9.0) mmol/L, Z=-15.449, P<0.001], but the difference in fasting blood glucose levels between the 2 groups after treatment was not statistically significant (Z=-1.427, P>0.05). The incidence of hypoglycemia in the insulin degludec group was lower than that in the insulin glargine U100 group [1.09% (6/552) vs. 2.83% (17/600), Z=4.481, P=0.032]. The intraday blood glucose standard deviation, maximum blood glucose fluctuation range, postprandial blood glucose fluctuation range, and average blood glucose fluctuation range in patients with complete blood glucose monitoring data in the insulin degludec group were significantly lower than those in the insulin glargine U100 group [(1.7±0.6) mmol/L vs. (2.4±1.0) mmol/L, (4.5±1.6) mmol/L vs. (6.7±2.9) mmol/L, (1.8±1.0) mmol/L vs. (3.3±1.2) mmol/L, (2.9±1.3) mmol/L vs. (4.6±2.1) mmol/L; all P<0.001]. Conclusion The efficacy of insulin degludec in the treatment of type 2 diabetes mellitus is equivalent to that of insulin glargine U100, but the risk of hypoglycemia and blood glucose fluctuation is lower.
  • 调查研究
    Than Hui①;Guo Daihong②;Chen Chao②;Liu Zhimin③;Yan Shuangtong①;Zhong Wenwen①;Lin Yang①;Zhang Dong④;Qian Xiaoshun④
    . 2006, 8(5): 339-342.
    Objective: To understand the effect of gatifloxacin on blood glucose levels in hospitalized patients. Methods: A retrospective study was performed by computer system. The data of blood glucose levels of 732 patients receiving gatifloxacin and 32 patients receiving erythromycin were analysed and compared between 1 June 2005 and 1 June 2006. The causality of dysglycemia associated with gatifloxacin and risk factors were evaluated by exculsion and case analysis. Results: Of 732 patients, 27(3.69%) were hyperglycemia, 8(1.09%)were hypoglycemia. Of 35 patients with dysglycemia, 24(68.57%) were no diabetic, 27(27.14%)were elderly patients (age>60 ). Thirty-two patients receiving erythromycin did not develop dysglycemia. All patients with dysglycemia were recovered after appropriate therapy. Conclusion: Dysglycemia may occur in patients receiving galifloxacin, especially in eldly patients. Clinicians should be aware of the risks of this adverse event and monitor blood glucose levels in all patients receivinggatifloxacin in order to ensure patient safety.
  • Chen Jingcheng, Ji Yuan, Zhu Meng, Zhou Xuejun, Zhu Aoshuang
    Adverse Drug Reactions Journal. 2018, 20(6): 426-430. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.006
    ObjectiveTo compare the efficacy and safety of long-term use of dabigatran and warfarin for prevention of stroke in elderly patients with atrial fibrillation. MethodsThe study was designed as a prospective randomized controlled trial. The subjects were outpatients or inpatients who were diagnosed as non-valvular atrial fibrillation and needed anticoagulant therapy in Changzhou No.2 People′s Hospital. The study started on March 20, 2015. Patients in accordance with the inclusion criteria were randomly divided into the dabigatran group (dabigatran 110 mg, twice daily) and warfarin group (warfarin dose was adjusted by regular follow-up results to maintain INR in the range of 2.0-3.0). After two years of follow-up, effectiveness of preventing thromboembolism events and occurrence of hemorrhagic events were compared between the two groups; occurrence of extracranial hemorrhage was also compared in patients with different ages (<60 years old group, 60-<80 years old group,  ≥80 years old group) between the two groups.ResultsUp to October 2015, a total of 180 patients were enrolled, including 114 males (63.3%) and 66 females (36.7%); 65 patients (36.1%) were <60 years old, 108 patients (60.0%) were 60-<80 years old, and 7 (3.9%) were ≥80 years old. There were 90 patients in the dabigatran group and in the warfarin group, respectively. During the period of 2-year follow-up, stroke and non-central nervous system embolism occurred in 6 patients and intracranial hemorrhage in 5 patients in each group, extracranial hemorrhage occurred respectively in 12 and 16 patients in the warfarin and dabigatran groups, without statistically significant differences (P>0.05 for all comparisons). Comparisons of the extracranial hemorrhage incidences in patients with different ages between the 2 groups showed that the incidence of extracranial hemorrhage in patients <60 years old in the dabigatran group was lower than that in the warfarin group (11.4% vs. 13.3%); the incidences of extracranial hemorrhage in patients aged 60-<80 and ≥80 years in the dabigatran group were higher than those in the warfarin group (19.6% vs. 12.2%, 50.0% vs. 33.3%, respectively), without statistically significant differences (P>0.05 for all comparisons).ConclusionsThe effectivenessfor preventing stroke and the incidences of hemorrhagic events were respectively similar in elderly atrial fibrillation patients with long-term use of dabigatran and warfarin. The risk of extracranial hemorrhage in very elderly patients needs to be further studied by expanding the sample size.
  • Adverse Drug Reactions Journal. 2020, 22(3): 173-175. https://doi.org/10.3760/cma.j.cn114015-20200220-00142
    为充实抗击疫情一线的药学力量,中国药理学会药源性疾病学专业委员会和中国医院协会药事管理专业委员会委托多名药学专家讨论并撰写了本文,从个人素质、工作经历以及专业实践能力3个方面提出对支援一线药师的胜任力要求,并对准备赴一线药师的能力提升给予建议。本建议适用于为选拔赴抗击疫情一线的药师提供指引,也可为其他地区对拟赴抗疫一线药师的培训提供参考。
  • Yan Shubin, Liu Xiao, Bu Yishan
    Adverse Drug Reactions Journal. 2020, 22(9): 543-544. https://doi.org/10.3760/cma.j.cn114015-20191230-01105
    An 86-year-old male patient received IV infusions of meropenem (1 g once per 12-hours) combined with ciprofloxacin lactate and sodium chloride injection (200-mg once daily) for pneumonia, respiratory failure, and multidrug resistant Pseudomonas aeruginosa infection suggested by sputum bacterial culture. On the 4th day of treatments, the patient developed a sudden drop in blood pressure, and his pulse could not be measured. ECG monitoring suggested ventricular fibrillation. After the treatments of electric defibrillation and amiodarone injection, his sinus rhythm restored. The next day the patient had another three episodes of ventricular fibrillation. All electrolytes were normal during emergency examination and ECG examination showed that the QT interval was normal. Ciprofloxacin was discontinued and replaced by meropenem combined with fosfomycin, and ventricular fibrillation did not recur. Twenty-six days later, the patient′s pneumonia was aggravated and sputum bacterial culture result showed multidrug resistant Pseudomonas aeruginosa infection, which was sensitive to ciprofloxacin and moderately sensitive to levofloxacin. Then meropenem (the same dosage and usage as before) combined with levofloxacin injection (200-mg once daily) were given. On the fifth day of treatments, the patient developed ventricular fibrillation again and his heart rhythm returned to normal after electric defibrillation and amiodarone treatment. Levofloxacin was discontinued and meropenem combined with fosfomycin were given again. Then ventricular fibrillation did not recur. The patient′s ventricular fibrillation was considered to be possibly related to ciprofloxacin and levofloxacin.
  • ADE简报
    . 2001, 3(3): 201-201.
  • 中毒救治
    . 2006, 8(1): 42-44.
    百草枯对人畜均有很强的毒性,近几年,因其中毒的病例呈上升趋势,但至今对百草枯中毒的治疗国内外尚处于研究阶段,对各种救治方法的疗效存在较大争议。本文就百草枯中毒的机制、病理改变、临床表现以及目前百草枯中毒救治的主要措施进行简要概述。
  • Sun Lirui, Zhou Wei, Tian Xu, Zhang Hongmei, Guo Qiushi
    Adverse Drug Reactions Journal. 2021, 23(6): 332-334. https://doi.org/10.3760/cma.j.cn114015-20201204-01210
    A 42-year-old male patient, who suffered serious wound pollution due to falling after drinking, received an intravenous infusion of levofloxacin hydrochloride injection 0.2 g dissolved in 0.9% sodium chloride injection 250-ml to prevent infection. When the first dose of levofloxacin was infused intravenously for about 2-minutes (about 4-ml), the patient suddenly developed dyspnea, restlessness, and agitation. His heart rate was 120 beats per minute, breath rate was 26 times per minute, blood pressure was undetectable, and blood oxygen saturation was 0.80. Levofloxacin was immediately discontinued and antiallergic therapy such as epinephrine and dexamethasone was given. Two minutes later, the patient′s heart rate dropped to 50 beats per minute, breathing decreased to 8 times per minute, and cyanotic appeared on the skin. Anaphylactic shock and type 2 respiratory failure were diagnosed and cardiopulmonary resuscitation, tracheal intubation, balloon assisted ventilation, and norepinephrine etc. were given immediately. Three hours later, the patient developed dark urine and elevated creatine kinase (CK), myoglobin, alanine aminotransferase, aspartate aminotransferase, and serum creatinine (Scr). His peak value of CK was 17-160-U/L, myoglobin was >3-000-μg/L, and peak value of Scr was 492-μmol/L. Rhabdomyolysis with acute kidney injury was considered. The symptomatic and supportive treatments such as hemofiltration, plasma infusion, correction of acidosis, and fluid replacement were given. Ten hours later, the patient′s blood pressure returned to normal, ventilator assisted breathing was continued, and the patient′s condition was gradually improved. Thirty-four days later, the levels of myoglobin, CK and Scr returned to within the normal range. Thirty-eight days later, the patient returned to spontaneous breathing and the ventilator was withdrawn.
  • 学术研究
    . 2005, 7(1): 7-10.
    为临床提供安全、有效、合理及经济的药品是医院药师的责任。要是在实际工作中发现药品潜在的安全性问题时,应及时与患者和医生沟通及交流,有助于减少差错,提高用药安全性,同时加强对患者用药教育也是要是面临的新挑战。本文就药品质量、用药教育并结合工作中遇到的问题进行探讨。
  • 病例报告
    Li Songyang
    . 2009, 11(4): 277-2.
    A 74yearsold women was hospitalized with acute bacillary dysentery. The patient remained in shock despite treatment with antiinfectives, fluid supplement, fluid expansion, dopamine, and metaraminol. Subsequently, she received IV Shenfu 20 ml in 5% glucose 20 ml, and then an IV infusion of Shenfu 80 ml in 5% glucose 500 ml. Thirty minutes later, her blood pressure increased from 60/40 mm Hg to 90/60 mm Hg, but she presented with arrhythmia, and her atria premature beat frequency was 8~12/min. Shenfu injection was withdrawn and changed to an infusion of hydroxyethyl starch 500 ml. Thirty minutes later, her atrial premature beats disappeared.
  • 病例报告
    Cao Yantao;Li Zhenzhou;Zhang Xin;Zhang Yaofen
    . 2007, 9(4): 279-280.
    A 78-year-old man with facial paralysis was given nifedipine,vitamin B1,cobamamide,sodium asscinate,and Xue-saitong injection after admission.And zolpidem at bedtime was given for his inability to sleep.During the 3 days of zolpidem treatment,in the first day,the patient fell asleep within 1 hour after ingestion of zolpidem 10 mg.And 3 hours later,the man got up,walked and talked with somebody while asleep.But he had no memory of that event subsequently.In the second day,the patient took zolpidem 5 mg,and no such behaviours occurred.In the third day,he developed the behaviours again 5 hours after ingestion of zolpidem 10 mg.After discontinuation of zolpidem,the behaviours did not recur.
  • 滥用误用
    Li Mengying;Gan Qiongping;Li Zhuoman
    . 2007, 9(4): 265-266.
    A 21-year-old female with lumbar pain took phenylbutazone 0.2 g thrice daily and prednisone 10 mg thrice daily.About 26 days later,she developed a fever,dark urine,oedema,skin rash.Three days later,the drugs were stopped,but her symptoms continued aggravating.Nine days later,she was admitted.Her body temperature was 38.7 ℃ and pulse was 112 beats/min.She presented with severe yellowing of skin and sclera.Laboratory tests revealed the following values:Tbil 190.9 μmol/L,Dbil 132.2 μmol/L,Alb 29 g/L,Glob 31 g/L,ALT 251 U/L,AST 64 U/L,ALP 233 U/L,γ-GT 251 U/L,LDH 594 U/L,WBC 13.5×109/L.A lumbar MRI showed the 3rd and 4th lumbar vertebral body tuberculosis.The patient was given the anti-infective therapy,supportive therapy,methylprednisolone pulse therapy,and plasmapheresis.But her jaundice was aggravated gradually,and she developed abdominal distention,oliguresis,deep red-cloured tabular ecchymosis on trunk and limbs.Her levels of BUN and Cr were 15.5 mmol/L and 189 μmol/L,respectively.A B-scan ultrasound displayed a great quantity of seroperitoneum.A blood routine test revealed the values as follows:WBC 1.7×109/L,RBC 2.04×1012/L,Hb 58 g/L,PLT 19×109/L.A bone marrow examination showed acute aplastic crisis.The patient died on day 9 after admission
  • Xie Zhenguo, Chen Lin, Yu Kun, Peng Zhe, Gong Hongmei, Liao Yunpeng, Lin Min
    Adverse Drug Reactions Journal. 2021, 23(2): 69-75. https://doi.org/10.3760/cma.j.cn114015-20200706-00742
    Objective To explore the risk and influencing factors of atrial fibrillation (AF) due to ivabradine. Methods The database of US FDA Adverse Event Reporting System (FAERS) was searched and the drug-related adverse event (AE) reports from the 2nd quarter of 2015 to the 4th quarter of 2019 were extracted. According to the first suspicious drug, the reports were divided into ivabradine group and other drugs group, which were further divided into AF event group and non AF event group, respectively. The signal intensity of AF events related to ivabradine was screened and statistically analyzed by reporting odds ratio (ROR). If the number of AF events was more than 3 and the lower limit of 95% confidence interval (CI) of ROR was more than 1, the AF signal was positive. The stability of the results was evaluated by subgroup analysis and sensitivity analysis and the adjusted ROR value was calculated using logistic regression model in order to reduce the influence of confounding factors. The differences of clinical characteristics such as age, gender, dose, and indications between patients in the AF event group and non AF event group were compared. The clinical characteristics with significant difference (P<0.05) were enrolled in the multivariate logistic regression model to analyze the influencing factors of AF induced by ivabradine. Results A total of 6-019-954 reports were entered in the analysis, including 1-799 cases (0.03%) in the ivabradine group and 6-018-155 cases (99.97%) in the other drugs group. There were 51 cases (2.83%) of AF events in the ivabradine group and 24-266 cases (0.40%) of AF events in the other drugs group. The overall ROR of AF events induced by ivabradine was 7.21 (95%CI: 5.45-9.52) and the overall adjusted ROR was 6.81 (95%CI: 5.13-9.02). The results of subgroup analysis and sensitivity analysis were consistent with the results of overall analysis basically. Multivariate logistic regression analysis showed that the risks of AF after ivabradine administration in the 70-79 years old and ≥80 years old patients were higher than that in the <60 years old patients [odds ratio (OR)=6.525, 95%CI: 1.896-22.456, P=0.003; OR=4.948, 95%CI: 1.050- 23.315, P=0.043]. Conclusions Ivabradine has a risk of AF. Advanced age may be associated with increased risk of ivabradine related AF.
  • 学术讨论
    . 2001, 3(4): 244-248.
    推断药物与不良事件之间因果关系过程就是因果评价。因果评价是一项严肃的工作,不仅是对患者安全用药的有力保护,而且也是对有限药物资源的维护,因果评价方法很多,其中常用的方法主要有全面内省法、联合评价法和贝叶斯法。这些方法各有利弊,善加利用,有助于解决药物不良事件因果评价中的疑难问题。
  • Feng Bo, Liu Peng, Zhang Yajun, Hu Peng
    Adverse Drug Reactions Journal. 2021, 23(8): 443-444. https://doi.org/10.3760/cma.j.cn114015-20210111-00041
    A 39-year-old female patient took omeprazole enteric-coated capsules 40-mg orally for stomachache. About 2.5-hours after the medication, the patient developed generalized itching, followed by urticaria like rash all over the body, dyspnea, and palpitations. Anaphylaxis due to omeprazole enteric coated capsules was considered. Anti-allergic drugs such as dexamethasone, calcium gluconate, and vitamin C were given immediately. Two hours later, dyspnea, palpitations, and pruritus were relieved and the rash completely subsided 3.5-hours later.
  • 调查研究
    Lu Shuwei;Cai Haodong
    . 2000, 2(4): 225-228.
    Objective: To find out the clinical indications of bifendate and the mechanism of its causing hepatic injury. Methods: Bifendate, 7.5 mg tid, was taken for 28 days in 64 patients with viral hepatitis who had the abnormal ALT and no jaundice, and their liver function changes were observed. Results: The effect of bifendate was related to the clinical types of hepatitis, the values of both AST and AST/ALT ratio before therapy. Conclusion: The protective effect of bifendate on liver remains to be studied.
  • Zhao Feiyan, Zhang Xialan, Qin Yuanyuan, Tang Qiuyue, Zhang Dengyu, Shen Xikun, Huang Yuyu
    Adverse Drug Reactions Journal. 2021, 23(7): 379-380. https://doi.org/10.3760/cma.j.cn114015-20201204-01212
    A 43-year-old female patient received Fuyanshu capsules 1.6 g orally thrice daily for pelvic inflammation. The traditional Chinese medicine decoction was added 1 week later. After 10 days of combination therapy, the patient developed fatigue, which was gradually aggravated, and yellowish skin and sclera appeared. Seven days later,laboratory tests showed alanine aminotransferase (ALT)>1-000-U/L, aspartate aminotransferase (AST) >750-U/L, gamma-glutamyltransferase (γ-GT) 148-U/L, alkaline phosphatase (ALP) 153-U/L, and total bilirubin (TBil) 56.3-μmol//L. After excluding viral hepatitis, autoimmune liver disease, obstructive jaundice, and other causes, liver injury caused by Fuyanshu capsules combined with traditional Chinese medicine decoction was considered. After Fuyanshu capsules and traditional Chinese medicine decoction were discontinued, reduced glutathione, glycyrrhizic acid preparation, and ursodeoxycholic acid were given. Seven days later, the patient′s symptoms were improved obviously and laboratory tests showed ALT 323-U/L, AST 125-U/L, γ-GT 149-U/L, ALP 109-U/L, and TBil 35.8-μmol/L。Twenty-seven days later, the patient′s symptoms disappeared and laboratory tests showed ALT 62-U/L, AST 42-U/L, γ-GT 67-U/L, ALP 67-U/L, and TBil 18.7-μmol/L. There are 7 same components in Fuyanshu capsule and traditional Chinese medicine decoction. It was considered that the liver injury was related to the increase of hepatotoxicity caused by the combination of the two drugs.
  • Li Yuan, Zhang Wenwen, Zhang Yuchen
    Adverse Drug Reactions Journal. 2024, 26(9): 530-534. https://doi.org/10.3760/cma.j.cn114015-20231211-00871
    Objective To mine risk signals of adverse events (AE) related to methylphenidate in children, and provide insights for the safe clinical use of the drug. Methods AE reports of children with methylphenidate as primary suspect drug were collected from the US FDA Adverse Event Reporting System (FAERS) database during the 1st quarter of 2004 to the 1st quarter of 2023. The AEs were standardized and classified using the preferred term (PT) and system organ class (SOC) of the Medical Dictionary for Regulatory Activities 26.0, and the reporting odds ratio (ROR) method and Bayesian confidence propagation nerve (BCPNN) method were used respectively to mine the AE risk signals of the drug. An AE with reports
    ≥3, the lower limit of the 95%CI of ROR>1,and information component (IC)-2SD>0 was defined as a risk signal. Descriptive analysis on the risk signals was performed. Results A total of 13?777 reports were collected. Two hundred risk signals were obtained using ROR and BCPNN method, involving 18 SOCs. Top 10 PTs in the number of reports were decreased appetite, aggression, headache, insomnia, agitation, psychomotor hyperactivity, anxiety, irritability, tics, and suicidal ideation, of which suicidal ideation was not recorded in the label; the SOCs involved were psychiatric disorders, metabolism and nutrition disorders, nervous system disorders. Top 10 PTs by signal strength were coronary artery dissection, Huntington′s disease, zoophobia, nail picking, polydipsia, lip?biting disorder, Alice in Wonderland syndrome, depression, onychophagia, and dermatillomania, all adverse reactions except depression were not recorded in the label; the SOCs involved were cardiac disorders, various congenital familial genetic disorders, and psychiatric disorders. Conclusions The main AEs related to methylphenidate in children are decreased appetite, aggression, headache, insomnia, and other adverse reactions recorded in the label. However, methylpheni- date may also lead to adverse reactions such as suicidal ideation, coronary artery dissection, Huntington′s disease, nail picking, and other adverse reactions not recorded in the label. Clinicians and pharmacists should be vigilant during the use of methylphenidate.
  • 综述
    Yang Xinghua;Zhan Siyan
    . 2008, 10(6): 381-6.
    Objective: The casecrossover study design proposed by Maclure in 1991 is a method to assess the transient effects on the risk of onset of rare acute events. The case-crossover study has the following features: only data from patients are required; this design allows each patient to serve as his/her own control; patient-level confounding variables, such as gender, are readily controlled; this study eliminates the bias in control selection. The case-crossover study is most suitable for evaluating relations within the following characteristics: the individual exposure varies within short time intervals; the disease has abrupt onset and short latency; the induction period is short. The case-crossover study has been applied in assessing several adverse drug events, such as vaccine safety, drug-induced skin reactions, drug exposure and insidious outcome, the suspected risks of illicit drug use. The case-crossover study is worth using in the investigation of acute adverse events.
  • 期刊评价
    Li Yanqiong;Sun Yanmin;Feng Yaping;Zhang Jing;Li Jiajia
    . 2008, 10(5): 0-0.

    Objective: To examine the frequency and type of citations of articles published in Adverse Drug Reactions Journal and to reveal the characteristics of citations in this journal. Methods: The citations of articles published in Adverse Drug Reactions Journal from 2003 to 2007 were collected. The frequency and type of the citations, Price index, and the top cited journal were statistically analyzed with bibliometris methods. Results: From 2003 to 2007, Adverse Drug Reactions Journal contained 385 articles, and 354 of them had a total of 4 849 references, for an average of 12.6 references per article. The citation rates were 91.9%. Of the 4 849 references, 89.3% were from journals, and 7.5% were from books. The Price index was 62.9%. The citations in the top 20 cited journals in citation frequency were 22.8% of the total citations. Conclusion: The citation of articles published in Adverse Drug Reactions Journal has characteristics of a large number and a wide range. The journal is one of the important sources in drug safety information.

  • 综述
    . 2001, 3(1): 1-5.
    为妊娠妇女及乳母处方非甾体抗炎药时,应谨慎权衡利弊。非甾体抗炎药作为前列腺素合成抑制剂可致凝血功能异常、子宫动脉导管收缩并延长产程。水杨酸盐对动物可致畸,但尚缺乏使人致畸的依据。孕妇使用阿司匹林可致分娩时及产前、产后出血,并致新生儿患出血性疾病。一般认为吲哚美辛对胎儿的循环有影响并能致畸,但也尚有争议。而萘普生对胎儿的循环、凝血以及肾脏功能均有影响。布洛芬、保泰松也可引起先天性缺损。因此,该类药物一般应避免使用于妊娠妇女。从物理、化学性质,药动学方面看,虽然大部分非甾体抗炎药在乳汁中的排泌率低,对乳儿的影响不大,但吲哚美辛由于半衰期长、代谢物仍有活性,乳母使用可能会使乳儿发生不良反应。而乳儿发生水杨酸盐毒性反应早有报道。乳儿肝肾功能未健全,乳母阿司匹林用量的21%又可通过乳汁被乳儿摄入,水杨酸盐应为乳母的禁忌药物。
  • 调查研究
    Cheng Xiaohong;Zhong Xin;Liu Cuizhong
    . 2002, 4(5): 301-303.
    Objective: To study the diagnosis, treatment and prognosis of antiepileptic drug hypersensitive syndrome (DHSS) . Method: 11 children with DHSS due to antiepileptic drugs (AED) during hospitalization from May 1995 to April 2002 were enrolled and followed up for the clinical data collected and analysed. Results: Fever, eruption, mucosal lesion, desquamation and pigmentation appeared in all patients. Moreover, liver damage occurred in 7 cases. Lymphadenovarix, heart and kidney disorders each occurred in 4. Marrow involvement was found in 2 and Stevens - Johnson syndrome in 1. All cases were given corticosteroid and clinic relief was observed thereafter. Followed up for 6 months, seven of 11 cases showed reversible internal organ dysfunction. Skin pigmentation still existed though. Seven cases with indication for the continuation of AED therapy switched phenytoin, carbamazepine and phenobarbi-tal to sodium valproate (5 cases) and topiramate (2), with no resulting hypersensitivity and seizure. Conclusion: DHSS usually occurs within 1 to 6 weeks after initiation of AED therapy, typically presents with fever, eruption and internal organ involvement. The prognosis is quite well if suspected drugs discontinue and the expectant treatment starts.
  • 中药不良反应
    Zhang Ming;Qian Lu;Wang Yuliang;Shi Geping;Chen Qian
    . 2009, 11(6): 448-2.
    A 53yearold woman with neurasthenia and neurosis received 4 Bushenyinao capsules thrice daily and estazolam 2 mg at bedtime. After 70 days, her mental symptoms recurred, accompanied by somnolence, yellowish skin and sclera. Liver function revealed the following values: ALT 274 U/L, AST 57.0 U/L, TBiL 32.4 μmol/L, DBiL 19.8 μmol/L and routine urine tests showed bilirubin (++), urobilinogen (++), and ketone (+). Bushenyinao capsules were stopped, estazolam was continued, and liverprotective treatments were given. Three weeks later, her liver function returned to within normal range.
  • 论著
    Wang Rui;Ren Zebin;Li Guofu
    . 2014, 16(4): 213-6.
    ObjectiveTo evaluate the efficacy and safety of dexmedetomidine in treatment of elderly patients in perioperative period.MethodsCNKI, CBM, VIP,WanFang Database, PubMed, Embase, Web of Science, and Cochrane Library from the inception to October 2013 were searched using "dexmedetomidine", "α2 receptor agonist", "elderly patients", "aged", "adverse reactions", "adverse drug reactions", "adverse events", and "safety" as key words. Randomized controlled trials (RCT) on dexmedetomidine treatment for elderly patients in perioperative period were collected and studies in accordance with inclusion criteria were analyzed with RevMan 5.2 software. The differences of heart rates during and after the operation, mean arterial pressure (MAP), the cumulative amount of fentanyl, and incidence of adverse reactions (vomiting, hypotension, bradycardia) between the dexmedetomidine group and the saline group were compared and the results were showed with weight mean difference (WMD), (relative risk,RR), and 95% confidence interval (CI).ResultsA total of 6 RCT papers involving 403 elderly patients (200 patients in the dexmedetomidine group and 203 patients in the saline group) were entered into this study. Of them, 4 RCT papers were high quality articles and 2 were low quality articles according to the Jadad scores. The heart rates and MAP in patients in the dexmedetomidine group were markedly lower than those in the saline group[heart rate: WMD =-11.70,95% CI (-13.76 to -9.65),P<0.01; MAP: WMD=-8.74, 95% CI (-10.81 to -6.68), P<0.01], the cumulative amount of fentanyl in patients in the dexmedetomidine group was markedly lower than that in the saline group [RR=-7.22,95%CI: -11.30 to -3.14, P<0.01]. There were no statistically significant differences in incidence of vomiting [RR=-0.11, 95% CI (-0.26 to -0.03)], bradycardia [RR=5.16,95% CI: 0.63 to 42.24], and hypotension [RR=1.01,95% CI: 0.28 to 3.69]in perioperative period between the two groups(all P>0.05).ConclusionDexmedetomidine could stabilize the heart rate and arterial pressure in elderly patients in perioperative period and have definite sedative effect and good drug safety.
  • 安全用药
    Liu Ran
    . 2009, 11(6): 416-4.

    Licorice is a commonly used traditional Chinese medicine which mainly contains glycyrrhizin ( glycyrrhizinic acid ), glycyrrhetinic acid, and flavonoid. Large dosage or longterm use of licorice or glycyrrhizinic acid may cause pesudohyperaldosteronism. Clinical presentations are increased blood pressure, palpitation, shortness of breath, arrhythmia, somnolence, generalised asthenia, tetraplegia, hypokalemia, lower limb and systemic edema, etc. The subjects prone to developing pseudohyperaldoteronism include the elderly, women, and those with cardiovascular disease or renal impairment. The mechanism of pseudohyperaldoteronism from licorice or glycyrrhizinic acid is associated with inhibition of 11 betahydroxysteroiddehydrogenase and increased activation of mineralocorticoid receptors. The measures of prevention and treatment are as follows: large dosage and longterm use of licorice or glycyrrhizinic acid should be avoid; the drug should be used very carefully in the elderly, the patients with cardiovascular disease, renal disease, hypertension, and diabetes mellitus; licorice or glycyrrhizinic acid in combination with cardiac glycoside or diuretics should be avoided; serum potassium level should be measured and blood pressure should be monitored regularly during drug therapy; once pseudohyperaldosteronism occurs, the drug should be stopped; patients with severe symptoms should be administered an appropriate potassium supplement, oral triamterence, and a low sodium diet.

  • 论著
    CHEN Zhang-zhang;Lü Qian-zhou
    . 2012, 14(4): 218-6.

    ObjectiveTo investigate the risk factors for linezolid-associated thrombocytopenia. Methods The clinical data of 162 in-patients receiving linezolid for infections in Zhongshan Hospital, Fudan University from January 2011 to July 2012 were collected and retrospectively analyzed. The patients were divided into the thrombocytopenia group and the normal platelet group according to the platelet count after linezolid administration. The main analytic indicators included sex, age, body weight,platelet count, serum creatinine clearance rate (Ccr),levels of albumin, hemoglobin, alanine aminotransferase(ALT)and aspartate aminotransferase (AST) before linezolid administration, dosage, administration route and duration of linezolid therapy, and the situation of drug combination. The correlated variables which affected platelet count were analyzed by t test, Mann-Whitney U test and Kruskal-Wallis H test, respectively. The selected risk factors were analyzed by stepwise Logistic regression, and the odds ratio (OR) and 95% confidence intervals (CI) were calculated. ResultsOne hundred and sixty-two patients comprised 113 male and 49 female with average age of (57.2±16.1) years. All of them received IV infusion of linezolid 600 mg twice daily. The duration of linezolid therapy was 1-46 days and the median time was 6 days. The platelet normal group comprised 115 cases and the thrombocytopenia group comprised 47 cases. The median time of thrombocytopenia onset in 47 patients was 4.5 days, the average count of platelet was (53±29)×109/L, the cases who developed mild, moderate and severe thrombocytopenia were 25,10 and 12, respectively. Stepwise Logistic regression analysis revealed the following results: before drug administration, the OR and 95% CI for Ccr<50 ml/min were 6.75 and 2.93~15.58, P=0.000; the OR and 95% CI for platelet count<100×109/L were 4.54 and 1.53~13.50, P=0.006; the OR and 95% CI for AST>75 U/L were 2.73 and 1.07~6.99, P=0.036; the OR and 95% CI for duration of linezolid therapy>14 days were 4.00 and 1.40~11.39, P=0.009. ConclusionThe Ccr and platelet count below normal, the AST level above normal before linezolid administration and the duration of linezolid therapy over 14 days may be the risk factors for linezolid-associated thrombocytopenia.

  • 安全用药
    WANG Tian-lin;GUO Dai-hong
    . 2012, 14(6): 365-4.

    Thrombocytopenia is one of the serious adverse reactions to linezolid. The risk factors for linezolid-induced thrombocytopenia are advanced age, female, long-term treatment, combined use of 3 kinds or more of antibiotics, lower baseline platelet count and renal insufficiency. Local symptoms of linezolid-induced thrombocytopenia are gingival bleeding, epistaxis, purpura and, in severe cases, gastrointestinal bleeding may occur. The most commonly seen general symptoms are fever, chills, generalized aching pain, nausea, vomiting, abdominal pain and arthralgia. The mechanism of thrombocytopenia induced by linezolid may be associated with bone marrow suppression, immune mediation or oxidative stress. Vitamin B6 might be effective in treating linezolid-induced thrombocytopenia, but the mechanism is presently unknown.

  • Yao Yao, Ge Weihong
    . 2016, 18(4): 293.
    A 48-year-old female patient was hospitalized 2 times for pseudotrichinosis. She received an IV infusion of methylprednisolone 60 mg once daily (changed to oral prednisone acetate 20 mg once daily after discharging) and oral methotrexate 10 mg once a week. After 107 days of treatments with the above-mentioned drugs, thalidomide 50 mg once daily by mouth was added because of recurrent erythra in her face and trunk. One hundred and thirty-six days later, methotrexate was withdrawn for the liver injury. Forty-eight days after receiving thalidomide, her skin rash was aggravated and accompanied by desquamation and erosion. Thalidomide was stopped. Anti-infective and anti-allergic treatments, skin protective treatments were given. Fourteen days later, her skin rash was ameliorated.
  • Shi Dingyi, Sun Yiming
    Adverse Drug Reactions Journal. 2020, 22(8): 488-489. https://doi.org/10.3760/cma.j.cn114015-20190403-00342
    A 59-year-old female patient mistakenly took air potato (Dioscorea bulbifera L.) as Polygonum multiflorum (1 steamed piece daily, and 2 on the last day) for healthcare. Ten days later, the patient developed jaundice, fatigue, anorexia, and nausea. Laboratory tests showed alanine aminotransferase (ALT) 1-090-U/L, aspartate aminotransferase (AST) 2-620-U/L, gamma-glutamyltransferase (γ-GT) 98-U/L, total bilirubin (TBil) 566.3-μmol/L, direct bilirubin (DBil) 301.5-μmol/L, and total bile acid (TBA) 351.4-μmol/L. Toxic hepatitis caused by air potato was diagnosed. IV infusions of compound glycyrrhizin injection, reduced glutathione for injection, and Yinzhihuang injection (茵栀黄注射液) and oral ursodeoxycholic acid tablets and traditional Chinese medicine decoction were given. After 25 days of treatments, her liver function were improved obviously, and laboratory tests showed ALT 39-U/L, AST 90-U/L, γ-GT 115-U/L, TBil 60.6-μmol/L, DBil 34.5-μmol/L, and TBA 121.5-μmol/L.
  • Wang Dongxue, Hou Jiqiu, Xu Feng
    Adverse Drug Reactions Journal. 2021, 23(6): 328-329. https://doi.org/10.3760/cma.j.cn114015-20201202-01198
    A 66-year-old female patient received gabapentin 0.3 g once daily for restless legs syndrome. After 3 days of medication, she developed muscle soreness, weakness of both legs, and dark brown urine. Laboratory tests showed myoglobin 2-855.0-μg/L, creatine kinase (CK) 3-009-U/L, CK-MB 61-U/L, serum creatinine (Scr) 542-μmol/L, urine protein (+++), and urine occult blood (+). Her lower limb muscle strength was grade 1. Rhabdomyolysis caused by gabapentin was considered. Then the drug was stopped, and the symptomatic treatments including rehydration, alkalized urine, diuresis, etc. were given. After 5 days of treatments, the patient′s dark brown urine and muscle soreness disappeared, weakness of both lower limbs was improved, and lower limb muscle strength returned to grade 3. Laboratory tests showed ALT 35-U/L, AST 55-U/L, myoglobin 929.0-μg/L, CK 325-U/L, Scr 557-μmol/L, urine protein (+), and urine occult blood (-). At a 1-month follow-up, the symptoms above-mentioned did not recur. Laboratory tests showed ALT 30-U/L, AST 38-U/L, myoglobin 135.0-μg/L, and CK 187-U/L.
  • Liang Huayu, Zhang Lan, Xing Xiaoxuan, Wang Sai, Wang Yuqin
    . 2017, 19(1): 22-30.
    ObjectiveTo understand the situation and influencing factors of potentially inappropriate medication(PIM) in elderly patients in outpatient and emergency departments in China.MethodsPrescriptions for patients aged ≥65 years with complete prescribing information from 79 hospitals in six cities including Beijing, Shanghai, Guangzhou, Tianjin, Hangzhou and Chengdu from February 1st, 2014 to December 31st, 2014 were collected. All prescriptions for elderly patients of 10 working days in each quarter were collected and the basic information (including region, hospital grade, gender, age, department, and major disease/disease status) and medication information (including drug name, drug specification, drug dosage form, drug dose, and the number of combined drugs) were recorded. The situation and influencing factors of PIM in elderly patients based on the Chinese PIM list and 2012 Beers criteria were analyzed.ResultsA total of 2 962 232 prescriptions were collected, of them, 1 499 201 were for male patients and 1 463 031 ones for female patients. The ages were from 65 to 120 years and the average age was (75±7) years. The number of combined drugs were 1-15 and the average number was 2.2±1.5. According to the Chinese PIM list (Chinese list,including 72 drugs)and 2012 Beers criteria (Beers criteria,including 124 drugs and 100 of them were in the Chinese market), the detection proportion of prescriptions for elderly patients containing PIM in outpatient and emergency departments were 15.81%(468 228/2 962 232)and 9.16% (271 250/2 962 232), respectively (P<0.001); the detection proportion of PIM varieties in prescriptions were 90.28%(65/72)and 70.00% (70/100), respectively (P<0.001); the detection proportion of PIM varieties with high risks or high recommendation and high evidence levels were 85.71% (30/35) and 67.50% (27/40), respectively (P=0.065). The proportion of prescriptions with one inappropriate medication in all PIM prescriptions were 91.83%(429 977/468 228) and 92.79%(251 696/271 250), respectively. The top 10 drugs in PIM prescriptions were clopidogrel, estazolam, alprazolam, doxazosin, nicergoline, zolpidem, diclofenac, insulin, olanzapine, and warfarin according to the Chines PIM list, and estazolam, alprazolam, doxazosin, terazosin, zolpidem, diclofenac, meloxicam, olanzapine, clonazepam, and spironolactone according to 2012 Beers criteria. Multiple logistic regression analysis showed that the cities, hospital grade, gender, age, departments for treatment, the number of combined medica-tions, and disease or disease states were independent risk factors for PIM. The risks of PIM in patients with sleep disorder, depression, coronary heart disease, Alzheimer disease, prostate hyperplasia and arthritis or joint pain were higher than in patients with other diseases or disease status.ConclusionsThe prevalence of PIM use according to the Chinese PIM list and 2012 Beers criteria in elderly patients in outpatient and emergency departments in China were not optimistic. Risk factors of PIM use in elderly patients in China were the regional distribution, hospital grade, gender, age, the number of combined medications, department for treatment, and disease/disease status.
  • 安全用药
    . 2005, 7(2): 111-113.
    血液制品是特殊的药品。应用血液制品的安全性值得关注。本文介绍了经输血传播的病原体、不同的血液制品感染和危险性以及血液制品输用中存在的问题,以供临床医务人员参考。
  • 综述
    . 2004, 6(4): 217-225.
    含马兜铃酸类成分中药导致的肾损害-马兜铃酸肾病近年受到国内外医药学界的广泛关注,本文根据10年来的临床与药学研究,从马兜铃酸肾病的临床特征、相关药物以及马兜铃酸的代谢过程、毒性作用及致病机制等方面进行了探讨,并提出了今后的研究方向。
  • Gong Junyan, Zhao Bo, Li Ruonan, Ai Jinwei, Zhou Xingjian
    Adverse Drug Reactions Journal. 2021, 23(12): 668-670. https://doi.org/10.3760/cma.j.cn114015-20210218-00182
    A 55-year-old female patient took acarbose, benazepril, and levamlodipine besylate intermittently and aspirin enteric-coated tablets and atorvastatin calcium regularly due to type 2 diabetes mellitus and hypertension, etc. After changing to bezafibrate for lipid-lowering and Gansulin 30R for glucose lowering (other treatments continued), the patient developed muscle soreness of both lower limbs and dark brown urine 7 days later. Laboratory tests showed aspartate aminotransferase (AST) 213-U/L, creatine kinase (CK) 8-655-U/L, CK-MB 555-U/L, lactate dehydrogenase (LDH) 579-U/L, α-hydroxybutyrate dehydrogenase (α-HBDH) 505-U/L, and myoglobin (MYO) 135-μg/L. Rhabdomyolysis was considered, which might be related to bezafibrate. Then bezafibrate was stopped. The patient was asked to drink plenty of water and urinate frequently, and the symptomatic and supportive treatments such as rehydration, alkalization of urine, liver protection, and kidney protection were given. After 11 days of drug withdrawal, her symptom of muscle soreness was relieved and the color of urine became lighter; laboratory tests showed CK 105-U/L and MYO 119-μg/L. After 18 days of drug withdrawal, the patient′s myalgia disappeared, urine color returned to normal; laboratory tests showed AST 37-U/L, CK 75-U/L, CK-MB 45-U/L, MYO 75-μg/L, and LDH 241-U/L.
  • 调查研究
    Shi Yili;Li Meiying;Zhu Qian;Li Kunyan
    . 2001, 3(2): 87-89.
    Objective: To discuss reasons for drug fever caused by Fufang Danshen Zhusheye. Methods: In accordance with the established method and Chinese Pharmacopoeia eight lots of the drug were tested for bacterial endo-toxin and impurities. Results: Of the eight lots, two which induced drug fever showed positive endotoxin test. Conclusion: The drug fever was relative to bacterial endoxin in Fufang Danshen Zhusheye
  • 论著
    Liu Shumin①*;Yao Zhuxing①;Zhang Lixia②
    . 2007, 9(1): 17-20.
    Objective: To observe the effects of milkvetch root (Radix Astragali) on hepatotoxicity induced by cocklebur fruit (Fructus Xanthii). Methods: Sixty-five male mice were divided into following five groups (13 mice in each group): 1:1 group (cocklebur fruit 5 g/kg plus milkvetch root 5 g/kg), 1:2 group (cocklebur fruit 5 g/kg plus milkvetch root 10 g/kg), 2:1 group (cocklebur fruit 5 g/kg plus milkvetch root 2.5 g/kg), cocklebur fruit group (cocklebur fruit 5 g/kg), and control group (physiological saline). The duration of administration was 4 weeks, and the weight of mice was measured weekly. After the last administration of the medicines, the serum levels of ALT and AST were measured, the liver index was calculated, and the GSH-PX, GST, and MDA of the liver were measured. Results: The weight gain in the 1:1 groups and 2:1 groups was marked higher than that in the cocklebur fruit group (P< 0.05), the liver index was lower than that in the cocklebur fruit group (P<0.05). The serum levels of AST and ALT in the three experimental groups were lower than those in the cocklebur fruit group, and there were statistically differences in comparison of the 2:1 group with the cocklebur fruit group. The activity of GSH-PX and GST in the 1: 2 group and 2:1 group were higher than those in the cocklebur fruit group, the differences were statistically significant (P<0.05; P<0.01). The content of MDA in the 1:2 group and 2:1 group were lower than that in the cocklebur fruit group, there were stastistically differences in comparison of the 2:1 group with the cocklebur fruit group (P<0.05). Conclusion: Milkvetch root could decrease the hepatoxicity of cocklebur fruit, and the 2:1 groupis better than other ones.
  • 调查研究
    Qi Xiaolian;Zhang Jingli;Ma Wenhui;Wang Yuqin
    . 2007, 9(1): 24-27.
    Objective: To investigate the situation of antibacterial-associated diarrhea occurring in our hospital. Methods: Forty-four patients with antibacterial-associated diarrhea in our hospital were investigated and analysed retrospectively from January to June in 2005. Results:The antibacterial-associated diarrhea accounted for 41.5% of infectious diarrhea. Most of patients with antibacterial-associated diarrhea were elderly patients and patients with liver or renal dysfunction. The common causative agents were levofloxacin, cefoperazone / sulbactam, clindamycin, and so on. All these agents were given by intravenous infusion. The initial time of onset of diarrhea occurred 2 days after the start of antibacterial drug therapy. The symptoms of diarrhea disappeared after 7 days of treatment with antifungal agents and microecological preparations. Conclusion:Intraveously administered antibacterial drugs may cause diarrhea; therefore, physicians should be care of using these drugs in treating patients, especially in elderly patients and patientswith liver or renal dysfunction, in order to avoid the occurrence of diarrhea
  • Zhang Zhihui, Zhang Lingli, Zhang Yongjun, Wan Chaomin, Liang Yi, Huang Liang, Quan Shuyan, Hu Zhiqiang
    . 2016, 18(3): 188.
    ObjectiveTo evaluate the safety of metoclopramide in children.MethodsReports on clinical studies involving metoclopramide treament in children were searched at PubMed, Embase, Cochrane Library, CNKI, VIP, and Wanfang Database from inception to September 2014. Adverse drug reaction information bulletins and pharmacovigilance information related to metoclopramide were searched from China Food and Drug Administration (CFDA), US FDA, Health Canada, and European Medicines Agency (EMA). The relationship between the adverse reactions and metoclopramide were evaluated using evaluation criteria of WHO and the characteristics of adverse reactions were descriptively analyzed.ResultsA total of 54 articles in accordance with inclusion criteria were entered in this study. No RCT was included. A total of 646 cases of adverse reactions were reported in the 54 articles. Of them, 42 cases of adverse reactions in the 29 case reports were reported and 604 cases in the 25 case series reports were reported. In the 646 children, 352 cases were males and 284 were females with ages from 2 months to 18 years old, of them, 174 cases (26.9%) were <1 year, 367 cases (56.8%) were 1-6 years old, 85 cases (13.2%) were 6 to 14 years old, and 20 cases (0.03%) were >14 years. Among the 42 cases of adverse reactions, 29 cases had extrapyramidal reactions; 4 cases had gynecomastia; 2 cases had nausea syndrome and apnoea, respectively; 1 case had hyperaldosteronism, skin rashes, blood pressure increase, and circulatory failure, respectively; 39 cases were cured, 2 cases were improved but sequelae remained, and 1 case was transferred to other hospital for treatment. All adverse reactions among the 604 cases of adverse drug reactions in the 25 case series reports were extrapyramidal reactions, all patients were cured without sequela. It was reported that 16 cases of 58 cases with adverse reactions in 2008 CFDA Bulletins were children. In 2011 and 2009, the FDA and Health Canada warned that long-term or large doses of metoclopramide could cause tardive dyskinesia. In 2013, the EMA recommended that metoclopramide was limited to short-term use (≤5 d), should not be applied to children under 1 year of age and only as second-line drugs for the prevention of nausea and vomiting in chemotherapy and postoperative treatments in children >1 year of age.ConclusionThe risks of extrapyramidal reactions and other serious adverse reactions existed in children with conventional dose of metoclopramide.
  • Yuan Tangjuan, Xu Jiadong, Gu Lili, Liang Pei, Lu Hong
    . 2016, 18(1): 8.
    ObjectiveTo explore the effect of different dosage of acyclovir (ACV) on renal function and its mechanism in mice.MethodsThirty ICR mice were divided into the control, ACV 150 μg/g and 600 μg/g groups by complete randomization method. Each group comprised 10 mice. The mice in the ACV 150 and 600 μg/g groups were injected with different dosage of ACV, the control group were injected with same volume of 0.9% sodium chloride via caudal vein once daily for 7 days. The mice′ body weight before the first medication and after the last medication was weighed. The levels of serum creatinine (Scr) and urea nitrogen (BUN) after medication were detected. The mice were sacrificed after collecting the blood samples. The mice kidneys were weighed and the renal coefficient was calculated. One kidney was used for pathologic examinations, and the other was for detection of expression of kidney injury factor-1 (KIM-1), interleukin-6 (IL-6), tumor necrosis factor-ɑ (TNF-α) and transforming growth factor-β1 (TGF-β1) by immunohistochemical Envision two-step method. The expression score was calculated according to the staining intensity and the percentage of positive cells.ResultsOn day 7 of medication, the body weight of mice in the ACV 150, 600 μg/g groups were lower than that in the control group [(29.0±0.59) g, (23.6±3.0) g vs. (31.9±2.4) g, P<0.05, P<0.01], the renal coefficient and the levels of BUN and Scr in ACV 600 μg/g group were higher than those in the control group [(8.52±0.77)% vs. (6.04±0.71)%,P<0.01; (204 74) μmol/L vs. (133±30) μmol/L, P<0.01; (13.8±2.8) mmol/L vs. (6.9±1.2) mmol/L, P<0.05]. There were renal tubular dilatation and few inflammatory response cell in renal interstitium in the ACV 150 μg/g group and infiltration of flammatory cells in renal interstitium. There were infiltration of flammatory cells and fibroplasia in renal interstitium and some renal tubular deformation and necrosis in ACV 600 μg/g group. The expressions of KIM-1, IL-6, TNF- α and TGF-β1 in renal tissues of mice in the ACV 150 and 600 μg/g groups were all positive. The expression score of KIM-1 in ACV 150 and 600 μg/g groups were higher than that in the control group [(2.5±1.5), (4.2±2.1) vs. (1.0±3.2),both P<0.05]. The expression scores of IL-6,TNF-αand TGF-β1 in the ACV 600 μg/g were higher than those in the control group [(1.5±0.5) vs. (0.2±1.5), (6.5±1.5) vs. (3.0±2.3), (3.5±2.5) vs. (1.2±2.7), all P<0.05] . ConclusionsThe doses of ACV 150 and 600 μg/g can cause different degree of renal tubular damage and interstitial inflammation in mice. The renal toxicity of ACV may be related to the apoptosis induced by oxidative stress.
  • Li Xinlei, Tang Hongbo, Feng Xin
    . 2016, 18(3): 238.
    Two female patients who aged 42 and 33 years with adenomyosis  and hysteromyoma, respectively  were  hospitalized for surgical treatment. They had not history of kidney disease. They developed the symptoms of nausea, vomit, hematuresis, hypourocrinia, and slight puffy swelling after the second and fourth times of IV infusion of amoxicillin and clavulanate potassium 2.4 g, respectively. Laboratory examination showed  the increase of serum creatinine (Scr) and urea nitrogen (BUN)(case 1: Scr 423 μmol/L, BUN 7.2 mmol/L;case 2:Scr 443 μmol/L, BUN 6.8 mmol/L). Amoxicillin and clavulanate potassium were stopped to use in both patients immediately and symptomatic treatments which included those for relieving vomiting, hemostasis, diuresis, and fluid infusion were given to them. The two patients were transferred to another hospital′s   nephrology department for hemodialysis on day 5 and 3 of receiving amoxicillin and clavulanate potassium, respectively. The two patients′ urine volume, levels of Scr and BUN were returned to normal on day 18 and 20 after transferring, respectively (case 1: Scr 49 μmol/L, BUN 4.1 mmol/L;case 2: Scr 55 μmol/L, BUN 5.1mmol/L).
  • 药源性疾病
    Liu Yuanmei;Li Xiaomei
    . 2008, 10(4): 0-0.
    Druginduced acute renal failure (DARF) refers to a clinical syndrome characterized by acute disturbances of water and electrolytes, acidbase imbalances, and azotemia. DARF is a common druginduced disorder, accounting for about 19 to 40 percent of parenchemal acute renal failure. Its clinical features were the occurrence of oliguria-or nonoliguria-type ARF several days or weeks after the exposure to causative drugs. A part of patients may present with drug rash, fever, anemia, liver injury, nervous system impairment, and so on. The most common clinicalpathological types of DARF include acute tubular necrosis and acute interstitial nephritis. The main mechanisms of DARF involve in renal hypoperfusion secondary to hemodynamics alteration induced by drugs, acute tubular necrosis caused by toxicity to tubular epithelial cells, acute interstitial nephritis caused by hypersensitivity, lumens obstruction resulting from drug crystal deposition and glomerulonephritis mediated by immune reaction. The relevant risk factors for DARF include nephrotoxicity of drugs, dosage, treatment duration, and the patients’ status, such as advanced age, blood volume insufficiency, diabetes, previous kidney damage or renal insufficiency, etc. Common drugs associated with DARF include antibiotics, nonsteroid antiinflammatory drug, diuretics and certain medical Chinese herbs. The key point of this article is to introduce the clinical features, prevention and treatment of DARF caused by drugs frequently used in cardiovascular systems, gastrointestinal systems, and anti-virus drugs.
  • Chen Can, Li Qianwen, Wang Chunhui, Pang Yushi, Li Xiaoyu
    Adverse Drug Reactions Journal. 2022, 24(9): 462-470. https://doi.org/10.3760/cma.j.cn114015-20220302-00167
    Objective To evaluate the preventive effect of angiotesion converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB) and beta-blockers against trastuzumab-related cardiotoxicity in patients with breast cancer. Methods Databases of PubMed, Embase, and Web of Science and Clinical Trials.gov were searched (up to February 28, 2022) and randomized controlled trials (RCTs) on ACEI/ARB or beta-blockers in preventing trastuzumab-related cardiotoxicity in female breast cancer patients, who were treated with trastuzumab containing regimens and without underlying cardiac diseases, were collected. Patients in the trial group were given intervention measures of ACEI, ARB, or beta-blockers while those in the control group were given placebo or no intervention. The primary outcome indicator was the change of left ventricular ejection fraction (LVEF) from baseline, and the secondary outcome indicators were the incidence of cardiotoxic events, the incidence of trastuzumab discontinuation, and the change of blood pressure. Random effects model in Revman 5.4 was used for meta-analysis, the effect sizes of enumeration data were the relative risk (RR) and its 95% confidence interval (CI), and those of measurement data were the mean difference (MD) and its 95%CI. Results A total of 4 RCTs and 844 patients were included in the analysis, including 520 patients in the trial group and 324 patients in the control group. The results of the meta-analysis showed that patients in the trial group treated with ACEI/ARB had a lower LVEF reduction (MD=1.37%, 95%CI: 0.49%-2.25%, P=0.002) and higher mean value of systolic blood pressure decrease (MD=-5.99-mmHg, 95%CI: -9.15--2.83-mmHg, P<0.001) than those in the control group; patients in the trial group treated with beta-blockers had a lower risk of trastuzumab discontinuation due to cardiotoxicity than those in the control group [14.4% (27/187) vs. 26.6% (49/184), RR=0.55, 95%CI: 0.36-0.84, P=0.006]; other outcome indicators including the risk of cardiotoxic events in the patients of the trial group treated with ACEI/ARB or beta-blockers were not significantly different from those in the control group (all P>0.05). Conclusion ACEI/ARB may have a certain preventive effect on trastuzumab-related LVEF reduction in breast cancer patients, but ACEI/ARB and beta-blockers could not reduce the risk of trastuzumab-related cardiotoxic events.
  • 安全用药
    . 2003, 5(6): 383-388.
    以头孢地嗪为代表的许多抗菌药物,在治疗过程中通过增强机体防御系统对细菌的噬杀能力,改善宿主的防御功能,提升机体免疫力,产生协同抗菌作用;也有部分药物显示多重性的免疫调节作用,在某些情况下呈现免疫抑制功能。相关的研究表明有些药物在感染性疾病、免疫性疾病的治疗中具有较高的临床应用价值;同时也提示在实际应用中,不仅要考虑抗菌药对特定细菌的敏感性、抗菌强度,还应考虑抗菌药的体内药效、安全性与免疫调节作用的关系。
  • Yuan Wei, Li Yunjing, Xu Ping, Liu Wenhui
    Adverse Drug Reactions Journal. 2020, 22(8): 477-478. https://doi.org/10.3760/cma.j.cn114015-20190305-00207
    A 56-year-old male patient with recurrent renal cell carcinoma and splenic metastasis received oral sunitinib 50-mg/d (4 weeks of medication and 2 weeks of withdrawal were defined as 1 cycle; the dosage was reduced to 25-mg/d after 2 cycles). And intravenous infusion of pembrolizumab 100-mg once every 3 weeks was added because of his illness. After 3 cycles of sunitinib and 5 cycles of pembrolizumab treatments, the patient developed muscle and joint pain, joint swelling, movement disorder, abnormal limb sensation and gradually developed symptoms such as difficulty in defecation, choking of drinking water, dysphagia, and dyspnea. The patient was diagnosed as Guillain-Barre syndrome after neurologist consultation, which might be related to the combination use of sunitinib and pembrolizumab. The above 2 drugs were stopped and dexamethasone and human immunoglobulin (pH4) for intravenous injection were given. Three days later, the patient could turn over on his own; 5 days later, his symptoms of dysphagia, dyspnea, and muscle and joint pain were relieved; 10 days later, he could stand beside the bed; one and a half month later, he could walk independently.
  • Xu Yong, Feng Jihong
    . 2016, 18(1): 35.
    Nucleoside/nucleotide analogues (NAs) which used to treat chronic hepatitis B and had been in the domestic market include adefovir dipivoxil (ADV), tenofovir (TDF), lamivudine ( LAM), telbivudine (LDT) and entecavir (ETV).  ADV and TDF have nephrotoxicity , LAM and ETV have a lesser effects on kidney function , and LDT has certain effect of improving kidney function. The diagnostic criteria of kidney injury due to NAs are serum creatinine (Scr) level higher than that of the baseline value (>44.2 μmol/L) or serum phosphorus level lower than that of the baseline value (<0.5 mmol/L) on two successive detections. The incidence rate of kidney injury due to ADV was higher than that due to TDF. The clinical manifestation of kidney injury due to ADV and TDF was Fanconi syndrome. The patient develops local or systemic osteodynia, osteoporosis, and amyasthenia, even limitation of activity and halisteresis in serious cases. The laboratory tests show increase in Scr, decrease in serum phosphorus and uric acid. The mechanisms of nephrotoxicity of ADV and TDF are related to injury of renal tubular epithelial cell mitochondria, change of renal tubular transport protein, and accumulation of drugs in proximal convoluted tubule. The nephrotoxicity of NAs are related to dosage, patients′ age, body weight, baseline level of estimated glomerular filtration rate (eGFR), primary disease, genetic factor, diet and drug. The patient who takes ADV or TDF for long term should monitor SCr, serum phosphorus, eGFR, uric acid, microalbuminuria,and glucose in urine regularly. ADV or TDF should be stopped timely in the case of appearance of symptom of kidney injury. The medication should be changed to LDT or ETV. Phosphorus compounds, vitamin D and calcium should be given.
  • 综述
    . 2006, 8(5): 321-325.
    血管紧张素Ⅱ拮抗药物(包括血管紧张素转换酶抑制剂和血管紧张素受体拮抗剂)已在临床得到广泛使用,尽管安全性相对较好,但仍会出现不良反应,而且医生对其仍缺乏足够认识。本文对其作用机制、主要不良反应及其防治进行概述,以有助于合理应用该类药物。
  • Guan Xiaoyan, Chen Zhang, Ning Junjie
    Adverse Drug Reactions Journal. 2022, 24(6): 322-324. https://doi.org/10.3760/cma.j.cn114015-20211130-01205
    An 11-month-old female infant underwent liver transplantation due to congenital biliary atresia at the age of 4 months. She was treated with mycophenolate mofetil (MFF) combined with tacrolimus orally after the operation. Six months after the medication, the infant developed intractable diarrhea, which was not improved after the treatment of diarrhea cessation, parenteral and enteral nutrition supports. Laboratory tests showed that stool tests were negative for Salmonella, Shigella, Campylobacter, Clostridium difficile, Yersinia, Enterotoxigenic Escherichia coli, and parasites; plasma cytomegalovirus DNA was negative. Serum concentration of tacrolimus was 9.3-mg/L. Colonoscopy and pathological examination showed characteristics of inflammatory bowel disease. Colitis caused by MMF was considered. Then MMF was discontinued and other treatments were continued. One week after the drug discontinuation, diarrhea stopped in the infant. At 1 month follow-up, diarrhea did not recur.
  • Wu Guiying, Sun Zhiqiang, Wuriliga, Wang Yong, Bai Lijie
    Adverse Drug Reactions Journal. 2022, 24(2): 96-98. https://doi.org/10.3760/cma.j.cn114015-20210318-00326
    Two patients (patient 1, a 59-year-old female; patient 2, a 67-year-old female) were treated with recombinant human tumor necrosis factor-α receptorⅡ: IgG Fc fusion protein (rhTNFR: FC) due to axial spondyloarthritis and rheumatoid arthritis, respectively. Patient 1 received subcutaneous injection of rhTNFR: FC 50-mg once a week. After 3 times of treatment, the patient developed miliary red papules on both upper arms, accompanied by pruritus. The patient stopped rhTNFR: FC by herself and the papules were relieved. Two weeks later, RhTNFR: FC was used again, the red papules on bilateral upper arms recurred and were aggravated, and miliary red papules on both shoulder and back and edematous erythema on left ankle were observed. Drug eruption due to rhTNFR: FC was considered. Then rhTNFR: FC was stopped. The drug eruption was relieved after 10 days of anti-allergic treatments and subsided 1 month later. Patient 2 received subcutaneous injection of rhTNFR: FC 50-mg once a week. After 4 times of treatment, scattered bean-size red papules appeared on her left lower limb, which gradually enlarged, accompanied by desquama- tion. Drug eruption due to rhTNFR: FC was considered. Then rhTNFR: FC was stopped and glucocorticoid, other anti-rheumatic drugs, and calcium supplement were given. Fourteen days later, the papule were almost disappeared.
  • 药物评介
    . 2006, 8(2): 148-151.
  • 病例报告
    Qu Caihong;Li Xiaoyan
    . 2011, 13(6): 374-4.
    A 35-year-old male patient was admitted to hospital because of severe chronic hepatitis B and spontaneous bacterial peritonitis. The patient received treatment with liver-protective drugs, medications used to treat jaundice, diuretics, a drug inhibiting the secretion of gastric acid (omeprazole) and anti-viral drug (adefovir dipivoxil and lamivudine). During the treatment, the patient developed pulmonary invasive fungal infections. The patient’s symptoms improved after treatment with caspofungin for 10 days. Subsequently, the patient was administered oral voriconazole at an initial dose of 0.4 g and then 0.2 g twice daily instead of caspofungin for economic reasons. On day 3 of voriconazole treatment, the patient developed frequent nausea and vomiting. His symptoms were not improved after symptomatic treatment. On day 10 of treatment, the patient was given an IV infusion of voriconazole 0.2 g twice daily. His frequent vomiting remained unchanged. On day 14 of voriconazole treatment, the patient developed muscle soreness in his extremities. Laboratory tests revealed following levels: AST 880 U/L, ALT 166 U/L, CK 22 855 U/L, and CK-MB 442 U/L. Voriconazole was discontinued, and 4 days later, his CK and CK-MB levels decreased to 5625 U/L and 73 U/L, respectively, but his AST and ALT levels increased to 1226 U/L and 396 U/L, respectively. The myopathy and worsening liver function were considered to be possibly related to adverse interactions between voriconazole and omeperazole. The patient finally developed severe hepatic failure and was discharged at his family’s request.
  • 病例报告
    HU Yang;WANG Lan;MEI Dan;ZHANG Bo
    . 2012, 14(5): 319-3.
    A 16-year-old female patient received escitalopram oxalate 10 mg once daily for anorexia nervosa. More than one month after receiving the drug, she presented to other hospital with amenorrhea. Liver function tests showed the following results: alanine aminotransferase (ALT) 222 U/L, aspartate aminotransferase (AST) 124 U/L, and albumin 45 g/L. Escitalopram oxalate was discontinued. One week later, the drug was readministered and liver-protective treatment was given at the same time. However, her liver function did not improved and she was hospitalized in Peking Union Medical College Hospital. On admission, her liver function tests showed the following results: ALT 3257 U/L, albumin 37 g/L, TBil 37.7 μmol/L, DBil 21.3 μmol/L. Escitalopram oxalate was stopped immediately and liver-protective drugs such as glutathione, S-adenosylmethionine, compound glycyrrhizin, polyene phosphatidyl choline, sodium glutamate, and potassium glutamate were given. Two months later, her liver function returned to normal, and she was discharged.
  • Zou Jun, Li Xin, Deng Mingfeng, Xie Jin, Huang Linlin
    . 2016, 18(1): 46.
    Variability of platelet response (VPR) is the differences of different people in response to antiplatelet drugs. Clopidogrel are commonly used as clinical anti-platelet drugs, it irreversibly blocks the platelet ADP P2Y12 receptor, inhibits the binding of ADP and platelet receptor and inhibits activation of ADP-mediated glycoproteinⅡb/Ⅲa complex, thereby inhibits platelet aggregation. Clopidogrel VPR mechanism is unclear, it may be linked to a combination of internal factors and external factors, external factors include patient race, age, body mass index, compliance, obesity, insulin resistance, disease states and drug interaction; internal factors include the absorption and metabolism, and platelet receptor gene polymorphism. The detection methods of clopidogrel VPR are mainly as vasodilator-stimulated phosphoprotein and adenosine diphosphate ADP as targets for testing. Summarizes evidence based medicine of clopidogrel and finding standard of platelet function testing method are important to implementing individualized treatment and evaluation of the prognosis.
  • Gao Ruya;Ji Liwei;Zhu Kongcai;Hu Xin;Cao Guoying
    . 2015, 17(1): 27-9.
    ObjectiveTo analyze the risk factors of adverse drug reactions related to iodinated contrast medium.MethodsAll the hospitalized patients, who underwent coronary angiography (CAG) or percutaneous coronary intervention (PCI) from April 20th 2013 to July 20th 2013 in Beijing Hospital, were investigated using a questionnaire on usage of iodinated contrast medium designed by the research group. The investigation included patients′ basic information, main discharge diagnosis, information on surgery, combined drugs, the results of laboratory tests before and after using iodinated contrast medium, and information on adverse drug reactions and adverse events. The questionnaire was filled in by the research group according to the patient′s subjective feelings one day after surgery and on discharge and the medical records. Using the patient′s sex, age, body mass index (BMI), CAG or PCI, usage of iodinated contrast medium, allergic history, history of drinking, coexisting diseases, kinds of iodinated contrast medium used this time, and combined drugs as independent variables, the whole iodinated contrast medium-related adverse reactions and adverse reactions of single system were studied by the single-factor analysis. The significant statistical variables were selected and the logistic regression analysis including odds ratio (OR) and 95% confidence interval (CI) was performed. ResultsTotally 581 patients were enrolled into this study; 364 were men (62.7%) and 217 women (38.3%) with an average age of (65±12) years (29-90). The patients′ levels of BMI were 15.8-41.0 kg/m2 with an average level of (25.5±3.4) kg/m2. Of them, 338 patients (58.2%) underwent CAG and 243 patients (41.8%) underwent PCI. The number of patients receiving iohexol injection (Shuangbei), iohexol injection (Omnipaque), iodixanol injection (Visipaque), and iopromide injection (Ultravist) were 173 (29.8%), 160 (27.5%), 164 (28.2%), and 84 (14.5%), respectively. And the dosage of iodinated contrast medium was 23-500 ml with an average dose of (136±77) ml. Of the 581 patients, 69 patients (11.9%) developed iodinated contrast medium-related adverse reactions. The incidences of Shuangbei, Omnipaque, Visipaque, and Ultravist were respectively 12.7% (22/173), 7.5% (12/160), 18.3% (30/164), and 6.0% (5/84) and there were no statistically significant differences among the different kinds (P<0.05, P<0.01). The 69 patients experienced 88 adverse reactions in total including 60 mild reactions and 28 moderate reactions. These reactions involved skin and accessories (23 reactions, 26.1%), central and peripheral nervous system (17 reactions, 19.4%), gastro-intestinal system (14 reactions, 15.9%), autonomic nervous system (12 reactions, 13.6%), urinary system (12 reactions, 13.6%), systemic disorders (8 reactions, 9.1%), and musculoskeletal system (2 reactions, 2.3%). The logistic regression analysis showed that the risk factors of skin and accessories disorders were duration of hospital stay (OR=1.083, 95%CI: 1.024-1.146, P=0.005), history of liver disease (OR=4.483, 95%CI: 1.815-11.072, P=0.001), and allergic history (OR=5.686, 95%CI: 2.136-15.135, P=0.001); the risk factors of gastro-intestinal system disorders were history of liver disease (OR=3.879, 95%CI: 1.110-13.552, P=0.034) and insulin use (OR=3.764, 95%CI: 1.087-12.027, P=0.036); the risk factors of central and peripheral nervous system disorders was allergic history (OR=6.778, 95%CI: 1.187-38.685, P=0.031); the risk factors of urinary system disorders was anti-infective drug use (OR=6.918, 95%CI: 1.425-33.589, P=0.016); the risk factors of musculoskeletal system disorders was BMI (OR=0.608, 95%CI: 0.376-0.984, P=0.043); the risk factors of the systemic reactions were history of liver disease (OR=2.925, 95%CI: 1.412-6.061, P=0.004), having PCI (OR=2.546, 95%CI: 1.071-6.054, P=0.034), underweight (OR=10.743, 95%CI: 2.040-56.572, P=0.005), and allergic history (OR=2.925, 95%CI: 1.191-7.183, P=0.019).ConclusionsThe main risk factors of adverse drug reactions related to iodinated contrast medium to different system were different. The main systemic risk factors of the iodinated contrast medium-related adverse reactions were history of liver disease, underweight, and allergic history.
  • . 2015, 17(3): 167.
  • 调查研究
    Feng Xia;Zhang Chunmei;Zhong Yi
    . 2005, 7(5): 332-335.
    Objective: To investigate the clinical manifestions and causative factors of adverse reactions following sufentanil injection in order to safe use of the drug. Methods: 173 cases treated with sufentanil in our hospital were retrospectively studied and the results were statistically analysed by SPSS (version12). Results: Of 173 patients, the adverse events were found in 33 cases with incidence 19.08%, and adverse reactions were found in 17 cases with incidence 9.83%. The main adverse reactions were cardiovascular and gastrointestinal reactions . The adverse reactions had no relation with sex, age of patients and combination use of drugs(P > 0.05), and they had relation with administration and dosage of sufentanil(P < 0.01). Most adverse reactions occurred 2- 6 hours after administration. Conclusion:Clinical adverse reactions caused by sufentanil should be mastered for safe use of the drug.
  • Ni Qian, Qi Wei, Tan Lin, Chen Lulu,Zhou Mofei, Hu Xin, Tan Ling
    Adverse Drug Reactions Journal. 2021, 23(8): 408-415. https://doi.org/10.3760/cma.j.cn114015-20210125-00107
    Objective To explore the role of medication safety self-assessment according to        “2011 ISMP Medication Safety Self Assessment for Hospitals (Chinese version)”(Chinese version of ISMP) in improving the level of medication safety in hospitals. Methods The main results of medication safety self-assessment conducted by Beijing hospital using the Chinese version of ISMP in 2018 and 2020 were compared and analyzed. The assessment was organized by The Drug Risk Management Group of The Professional Committee of Therapeutic Drug Monitoring in The Chinese Pharmacological Society and the content  included in the comparative analysis was 10 key elements, 20 core characteristics, and 161 evaluation items in the Chinese version of ISMP. Each item was scored referring to the Likert′s Five-Level Scoring and the corresponding score of choices A-E was 0, 0, 2, 3, and 4 respectively. The actual scores of the items and the percentage scores of 10 key elements in the 2 self-assessment activities were compared. Items with the greatest improvement (0 score in 2018 and 4 score in 2020) and those with no improvement (the score in 2020 was not higher than that in 2018) were found. Results The median actual score of 161 items in 2020 were higher than that in 2018 and the difference was statistically significant [4(3, 4) vs. 3(2, 4) scores, P<0.001]. The median percentage scores of items under key elements Ⅰ (patient information), Ⅱ (drug information), Ⅴ (drug standardization, storage, and distribution) were significantly higher than those in 2018 [75.5%(50.0%,100%) vs. 100%(100%,100%),P=0.002;25.0%(0,75.0%) vs.100%(75.0%,100%),P<0.001;50.0%(50.0%,100%) vs. 100%(100%,100%), P=0.003)]. In 2020, the percentage score of key element Ⅳ (drug labeling, packaging, and nomenclature) was 100%, the same as that in 2018; the percentage scores of the other 9 key elements were higher than those in 2018. Among them, the percentage score of key element Ⅶ (environmental factors, workflow, and staffing patterns) increased to 100% (94.2% in 2018) and those of the other 8 key elements were from 73.4% to 97.2%. There were 14 items with the greatest improvement and 1, 7, 3, 2, and 1 item of them was under key elements Ⅰ, Ⅱ, Ⅴ, Ⅵ (medication device acquisition, use, and monitoring), and Ⅷ (staff competency and education), respectively. However, there were 24 items that had not been improved and 2, 4, 2, 4, 1, and 11 items of them were under key elements Ⅰ, Ⅱ, Ⅴ, Ⅷ, Ⅸ (patient education), and Ⅹ (quality process and risk management), respectively. Conclusion Using the Chinese version of ISMP in self-assessment of medication safety in hospital will help improve the level of hospital medication safety.
  • Chen Bihong, Shen Yuqin, Hu Huaiqiang
    Adverse Drug Reactions Journal. 2022, 24(8): 435-436. https://doi.org/10.3760/cma.j.cn114015-20220110-00012
    A 54-year-old male patient with amyotrophic lateral sclerosis received mecobalamin, idebenone, coenzyme Q10, etc. After 1 week of treatment, edaravone injection, citicoline sodium capsules, and vitamin E capsules were added because the patient had no significant improvement in upper limb weakness, chest tightness, and suffocation. On day 10 of edaravone injection treatment, the patient developed increased sweat on his head and neck. Laboratory tests showed white blood cell count 1.7×109/L, neutrophil percentage 0.25, and neutrophil count 0.4×109/L. Neutropenia was considered, which might be related to edaravone. Edaravone injection was stopped, other treatments were continued, and a subcutaneous injection of granulocyte stimulating factor injection 150-μg was given once. Two days later, the white blood cell count was 9.6×109/L, neutrophil was percentage 0.72, and neutrophil count was 6.9×109/L.
  • 综述
    . 2002, 4(5): 292-296.
    为了解非典型抗精神病药物的不良作用,检索国外有关文献中临床试验的数据,比较典型与非典型抗精神病药物之间,及各种非典型抗精神病药物之间不良作用的差异。非典型药物致锥体外系综合症(EPS)、迟发性运动障碍(TD)发生率均低于典型药物;一般非典型药物血中催乳激素增高低于典型药物。其他不良作用的发生率可能与典型药物相同。非典型药物引起患者体重增加是值得关注的问题,在非典型药物之间,不良作用发生的类型、严重程度均有差异,临床医生选择用药应个体化。
  • 论著
    Luo Leiming;Fan Li;Zhang Ling;Xue Hao;Shi Jun;Liu Yu;Zhu Qiwei;Liu Guoshu
    . 2006, 8(2): 97-100.
    Objective: To evaluate the clinical safety following long-term use of simvastatin with usual dose in very elderly patients with angina pectoris. Methods: One hundred and sixty patients with angina pectoris over age 75 were selected for the research. The patients were assigned into simvastation group (in short: statin groups) and the control group, according to the second degree prevention criterion of cornary heart disease from Guideline in Prevention and Cure of Lipid Abnormality. Eighty-nine patients in statin group were administered simvastation 10-20 mg daily, besides anti-ischemia therapy, 71 patients in the control group received anti-ischemia therapy only. The treatment course was 12 months. Blood-lipid, blood-glucose, liver function, renal function and serum CK level were measured before treatment and druing the end of the first, third, sixth and twelfth month of the treatment, and a follow-up investigation with questionnaire and telephone interview was performed.Results: In statin group, the follow-up to ten patients were lose and one patient died. In the control group, the follow-up to eight patients were lose and 3 patients died. The comparison of adverse reaction incidence between statin group and the control group was as follows: elevated hepatic transaminase (5.1%, 5.0%, P>0.05), elevated creatine (3.8%, 5.0%, P>0.05), sleep disorder (10.3%, 10.0%, P>0.05) , dementia (5.1%, 5.0%, P> 0.05), gastrointestinal tract disorder (12.8%, 11.7%, P>0.05), and aggravated renal function (6.4%, 5.0%, P>0.05), there was no significant deference statistically between the two groups. Conclusion: Long-term use of simvastatin in an usual dose is safe for very elderly patients withangina pectoris.
  • 病例报告
    Li Runping;Xia Xin
    . 2007, 9(5): 360-361.
    A 44-year-old woman with varicosis received iopromide 370 100 ml,0.9% sodium chloride 40 ml,and dexamethasone 10 mg by bolus injection with a high pressure syringe at a speed of 2.5 ml/s before CT enhancement scanning examination.After intravenous injection,the patient suddenly presented with unconsciousness,respiration and cardiac arrest.He was given cardiopulmonary resuscitation,tracheal intubation,and antishock drugs immediately.Two hours later,the patient died.An autopsy showed extensive eosinophilic granulocyte infiltration in many organs and tissues,pulmonary edema,larynx and epiglottis edema.
  • Li Zhixia, Zeng Xiantao, Chai Sanbao, Quan Xiaochi, Wu Shanshan, Yang Zhirong, Zhan Siyan, Sun Feng
    . 2015, 17(3): 185.
    ObjectiveTo evaluate the risk of dyspepsia and anorexia due to glucagon-like peptide-1 receptor agonist (GLP-1 RA) in patients with type 2 diabetes mellitus (T2DM).MethodsThe electronic database of Chinese BioMedical Literature Database(CBMdisc), Chinese Medical Current Contents(CMCC), Medline, EMbase, the Cochrane Library and web site of ClinicalTrials.gov were searched from inception to May 1st 2014. Those randomized controlled trials whose inclusion criteria including patients with T2DM as the research object, comparisons of GLP-1 RA and placebo or other conventional anti-diabetic drugs as the intervention measures, and dyspepsia and anorexia as the outcomes were collected. A traditional Meta-analysis and a Network Meta-analysis were used and relational graph and rank ordering figure of all the intervention measures were drawn. ResultsA total of 42 randomized controlled trials were enrolled into this study involving 20 916 patients with T2DM and 13 kinds of intervention measures comprised 7 kinds of GLP-1 RAs (exenatide, exenatide release agent, liraglutide, lixisenatide, taspoglutide, albiglutide, and dulaglutide), 5 kinds of conventional anti-diabetic drugs (insulin, metformin, sulfonylureas, sitagliptin, and thiazolidinediones ketones), and placebo. The traditional Meta-analysis showed that, compared with placebo, the whole of GLP-1 RAs could increase the risks of dyspepsia [odds ratio(OR)=3.04, 95% confidence interval (CI): 1.79-5.16] and anorexia (OR=2.57, 95%CI: 1.69-3.91) and there were statistically significant differences (P<0.05). The Network Meta-analysis showed that, compared with placebo, albiglutide, exenatide, exenatide release agent, liraglutide, lixisenatide, and taspoglutide could increase the risks of dyspepsia with statistically significant differences (all P<0.05) and, of them, liraglutide was at the greatest risk and the risk was 7.69 (1/0.13) times as high as that of the placebo. Compared with insulin, metformin, sulfonylureas, sitagliptin, and thiazolidinediones ketones, GLP-1 RAs could also increase the risks of dyspepsia in the patients with T2DM and, of them, liraglutide was at the greatest risk,which was 13.58, 4.17 (1/0.24), 3.85 (1/0.26), 5.00 (1/0.20), and 3.70 (1/0.27) as high as that of insulin, metformin, sulfonylureas, sitagliptin, and thiazolidinediones ketones, respectively. Compared with placebo, dulaglutide, exenatide, liraglutide, and taspoglutide could increase the risks of anorexia with statistically significant differences (all P<0.05) and, of them, dulaglutide was at the greatest risk, 5.53 times as high as that of the placebo. Compared with insulin, sulfonylureas, thiazolidinediones ketones, and sitagliptin, GLP-1 RAs could also increase the risks of anorexia in the patients with T2DM ( all OR>1.00 except for lixisenatide versus sitagliptin ) and, of them, dulaglutide was at the greatest risk, 48.91, 16.65, 36.24, and 4.75 times as high as that of insulin, sulfonylureas, thiazolidinediones ketones, and sitagliptin, respectively. There was no statistically significant difference between two kinds of GLP-1 RAs for risks of dyspepsia and anorexia (all P>0.05). The risks of dyspepsia and anorexia due to the 13 kinds of intervention measures were ranked by rank ordering figure and liraglutide and dulaglutide were at the greatest risks.ConclusionBoth the traditional Meta-analysis and Network Meta-analysis showed that GLP-1 RAs could increase the risk of dyspepsia and anorexia in patients with T2DM.
  • 监测交流
    . 2005, 7(1): 61-63.
  • 安全用药
    . 2002, 4(6): 378-382.
  • 学术研讨
    . 2006, 8(4): 248-251.
    钙不仅是维持骨健康的基本元素,也是参与全身多系统生理功能的重要物质,补钙是防治骨质疏松症的基础措施。近期,美国WHI的研究结果对补钙引起了争议,本文认为该研究设计和实施方面的局限性影响了研究结果的可靠性和科学性,并限制了其推广价值。本文还进一步阐述了对钙的吸收,补钙与肾结石的关系,以及钙剂选择标准和专家共识意见,提出了科学、安全补钙的合理建议。
  • . 2016, 18(1): 1.
  • Adverse Drug Reactions Journal. 2020, 22(3): 194-196. https://doi.org/10.3760/cma.j.cn114015-20200305-00222
    洛匹那韦/利托那韦(LPV/r)是国家卫生健康委员会和国家中医药管理局推荐的新型冠状病毒肺炎(COVID-19)抗病毒治疗药物之一。几项体外试验研究结果显示,LPV/r有抑制SARS病毒和中东呼吸综合征(MERS)冠状病毒的作用,但也有研究并未发现其有抑制SARS病毒的活性或活性较弱。2篇文献报道了LPV/r治疗SARS有一定临床疗效,1篇文献报道了LPV/r治疗1例MERS患者取得成功。近来也有少量LPV/r治疗COVID-19的报道,但是均尚缺乏高质量的对照研究。
  • Adverse Drug Reactions Journal. 2020, 22(3): 176-179. https://doi.org/10.3760/cma.j.cn114015-20200222-00146
    新型冠状病毒肺炎疫情暴发后,数万名患者被隔离治疗,轻/中症患者被隔离在方舱医院集中治疗,有些患者可能会出现应激相关障碍。对出现焦虑、抑郁、胸闷、心跳加快等症状,病程不足3 d,且无法进行心理干预的患者,可以经验性给予苯二氮  类(BZD)药物治疗;当患者应激反应症状持续3 d没有明显改善时,建议启动治疗。治疗方法包括支持疗法、心理危机干预和药物治疗。药物治疗以对症治疗应激引起的焦虑、抑郁为主,其中抗抑郁药起主要治疗作用,BZD药物起辅助治疗作用。
  • 综述
    . 2003, 5(2): 73-76.
    本文探讨手性药物的代谢动力学及药效学特征,阐明其药理活性和不良反应实质。结果表明有些手性药物在临床上的应用是有益的,有些则会造成不良后果。因此,通过对手性药物的深入研究,对临床合理应用手性药物具有重要的意义。
  • Li Anxia, Xue Shuyi, Zhao Bingqing, Ping Yaodong
    Adverse Drug Reactions Journal. 2023, 25(11): 700-702. https://doi.org/10.3760/cma.j.cn114015-20220808-00726
    A 49-year-old male patient with primary hepatocellular carcinoma was treated with donafenib combined with tislelizumab. After 2 cycles of treatments, he developed persistent fever, poor appetite, fatigue, decreased white blood cells, hemoglobin, platelets, and fibrinogen, and significant increase of serum ferritin(91-501-μg/L) and splenomegaly. Hemophagocytic lymphohistiocytosis was diagnosed, which was consideredto be caused by tislelizumab. He received intravenous infusion of methylprednisolone 60-mg/d for 4 days, 40-mg/d for 7 days, 28-mg/d for 5 days, and at last, oral prednisone 35-mg/d was given, with dose reduction to discontinuation within 4-6 weeks. During the treatment, his laboratory tests results were improved. The patient did not use tislelizumab again and donafenib treatment was reused, and the above symptoms did not recur.
  • He Fei, Liang Xin, Mei Zhihong, Li Guohui
    Adverse Drug Reactions Journal. 2021, 23(8): 424-432. https://doi.org/10.3760/cma.j.cn114015-20210201-00141
    Objective To explore the clinical characteristics of hyponatremia associated with cyclophosphamide (CTX). Methods The diagnosis and management of a breast cancer patient with severe hyponatremia after CTX treatment in Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College was reported. The main clinical data of this patient and the relevant cases collected by searching PubMed, Embase, CNKI, and Wanfang database (as of January 26, 2021), including gender, age, indications of CTX, usage and dosage of CTX, time from the application of CTX to the occurrence of hyponatremia (latency), and clinical manifestations, treatment and outcome of severe hyponatremia, etc., was descriptively analyzed. Results A total of 34 patients were included in the analysis, including 4 males and 30 females, aged from 27 to 87 years with the median age of 56 years. The primary disease were malignant tumor in 22 cases (17 cases of breast cancer), systemic lupus erythematosus in 6 cases, glomerulonephritis in 3 cases, scleroderma in 2 cases, and monoclonal gamma globulinosis in 1 case. Among the 34 patients, 22, 8 and 1 of 31 patients who received CTX intravenously developed severe hyponatremia after the first, second and seventh dose of treatments, respectively. Among them, 27 cases had latency records, which were 3-96-h (median time 24-h) and 25 cases had latency ≤48-h. The latency of severe hyponatremia induced by oral CTX was 1 d, 21 d and 30 d, respectively. The lowest value of blood sodium in 34 patients was 102-124-mmol/L, and in 30 patients (88.2%) were less than 120-mmol/L. The main clinical manifestations were disturbance of consciousness (20 cases), nausea and vomiting (17 cases), and epileptic seizures (15 cases). Twenty-two cases (64.7%) underwent hydration rehydration in a short time before and after CTX treatment, 1 case did not undergo hydration rehydration, and 11 cases had no relevant descriptions. After severe hyponatremia occurrence, CTX treatment was discontinued in all 34 patients. After sodium supplementation and water restriction, blood sodium returned to normal 8 h ~ 24 d (median time 48-h) after drug withdrawal, and returned to normal within 5 d in 27 cases (79.4%). Of them, one patient was still in coma after blood sodium returned to normal, and was diagnosed with central pontine myelinolysis one week later. Conclusions CTX-associated severe hyponatremia mostly occurs within 48-h of intravenous administration and the latency of oral administration is longer. It occurs usually in patients with large amount of hydration and rehydration in a short time before and after medication. The prognosis in most patients is good when CTX is stopped, sodium is supplemented and water is limited.
  • 病例报告
    . 2005, 7(3): 218-218.
  • Qiu Xuejia, Cao Gexi, Duan Baojing, Dong Zhanjun
    Adverse Drug Reactions Journal. 2020, 22(7): 393-397. https://doi.org/10.3760/cma.j.cn114015-20200402-00345
    Objective To explore the clinical and pathological characteristics of heomlytic- uremic syndrome (HUS) induced by gemcitabine. Methods The relevant databases abroad were searched up to November 12, 2018. Case reports and clinical research papers about HUS induced by gemcitabine were collected. The patient′s general situation, use of gemcitabine, symptoms of HUS, relevant laboratory test results, renal biopsy results, time from medication to HUS onset, and the treatments and outcomes of HUS were recorded. The clinical and pathological characteristics of HUS induced by gemcitabine were analyzed by descriptive statistical method. Results A total of 61 patients were enrolled in the study, including 22 males and 35 females with 4 unknown gender. The age of patients ranged from 25 to 81 years. The primary diseases included pancreatic cancer in 22 cases, lung cancer in 18 cases, cholangiocarcinoma in 7 cases, mammary cancer in 5 cases, ovarian cancer in 4 cases, non-Hodgkin′s lymphoma in 2 cases, soft tissue sarcoma in 1 case, bladder cancer in 1 case, and kidney cancer in 1 case. HUS occurred in 2-34 months after the first application of gemcitabine, and the median time was 6 months. The cumulative dose of gemcitabine was 4-000-99-540-mg/m2 when HUS occurred, and the median cumulative dose was 19-100-mg/m2. Of the 61 patients, 54 patients developed HUS symptoms, including hypertension (43 cases, 79.6%), peri- pheral edema (31 cases, 57.4%), and dyspnea (20 cases, 37.0%), and 7 patients were asymptomatic. There were different degrees of increase in serum creatinine and lactate dehydrogenase and decrease in platelet and hemoglobin in 61 patients. Fifteen patients performed renal biopsy and the thrombotic microangiopathy were found in all cases. Gemcitabine were stopped after the occurrence of HUS in all patients, and therapies such as symptomatic treatments, plasmapheresis, hemodialysis, symptomatic treatments+plasmapheresis, symptomatic treatments+glucocorticoid, or rituximab or ikuzumab treatment on the basis of above- mentioned therapy were given. Of the 61 patients, HUS was improved in 34 (55.7%) cases, but 27 patients  (44.3%) died within 1-65 months after the occurrence of HUS, of which 13 cases (21.3%) died of HUS. Conclusions The main clinical manifestations of HUS caused by gemcitabine are hypertension, peripheral edema, and dyspnea. A few patients may be asymptomatic, but all develop abnormal laboratory indicators related to toxuria and hemolysis. The main pathological changes in the kidney are thrombotic microan- giopathy. The prognosis of HUS is poor. Severe cases can lead to death.
  • Xu Shanshan, Song Zhihui, Han Furong, Zhang Chao
    Adverse Drug Reactions Journal. 2020, 22(11): 625-630. https://doi.org/10.3760/cma.j.cn114015-20200303-00209
    Objective To explore the occurrence of potentially inappropriate medication (PIM) and its influencing factors in elderly inpatients in department of general internal medicine. Methods The medical record data of elderly patients (≥65 years) discharged from the Department of General Internal Medicine in Beijing Tongren Hospital, Capital Medical University between January 1st and December 31st, 2019 were collected. The occurrence of PIM in these patients during hospitalization was evaluated according to the 2019 Beers Criteria of the American Geriatric Association (2019 AGS Beers criteria) and Criteria of Potentially Inappropriate Medications for Older Adults in China (2017 Chinese criteria). Patients were grouped according to their gender, age (<75, ≥75 years), number of diseases (≤5, 6-9, ≥10), number of drugs (1-4, 5-9, ≥10), and length of hospital stay (≤7, 8-14, ≥15 d) and the occurrence of PIM between the groups was compared. Logistic regression was used to analyze the influencing factors of PIM, and the odds ratio (OR) and its 95% confidence interval (CI) were calculated. Results A total of 511 patients were included in the analysis. Of them, 257 were males and 254 were females, aged 65-103 years with a median age of 75 years; the number of drugs ranged from 2 to 75, with a median number of 18; number of diseases ranged from 1 to 27, with a median number of 11; length of hospital stay ranged from 3 to 73 days, with a median time of 12 days. According to the 2019 AGS Beers criteria, the incidence of PIM was 56.56% (289/511), involving 30 drugs and 618 times of drug administration. The top 3 drugs were diuretics (42.72%, 264/618), benzodia- zepines and benzodiazepine receptor agonists (16.34%, 101/618), and anticholinergic drugs (12.62%, 78/618). According to the 2017 Chinese criteria, the incidence of PIM was 55.19% (282/511), involving 31 drugs and 496 times of drug administration. The top 3 drugs were benzodiazepines and benzodiazepine receptor agonists (20.36%, 101/496), theophylline drugs (19.96%, 99/496), and clopidogrel (17.34%, 86/496). The results of logistic regression analysis showed that age (≥75 years), number of drugs (≥5), number of disea- ses (≥10), and length of hospital stay (>7 days) were risk factors for PIM (P<0.001 for all). Conclusions The incidence of PIM in elderly inpatients in Department of General Internal Medicine in our hospital were similar using the 2 criteria, but the drugs involved were different. Using different criteria to evaluate PIM can complement each other and help pharmacists find more PIM.
  • Wan Suxin, Xiang Yi, Huang Gu, Xiao Yaping, Sun Qiuyan
    Adverse Drug Reactions Journal. 2023, 25(11): 695-696. https://doi.org/10.3760/cma.j.cn114015-20220905-00819
    A 77 year-old female patient was treated with compound chlorhexidine gargle to rinse the pus cavity due to gingival abscess. After 10-minutes, the patient developed palpitation and pale face, followed by respiratory failure, undetectable blood pressure, inaccessible arterial pulsation, no spontaneous breathing, and disappearance of pupillary light reflex, which was considered as anaphylactic shock. Cardiopulmonary resuscitation, endotracheal intubation mechanical ventilation, intravenous infusion of dopamine, intravenous injection of epinephrine and other resuscitation were given immediately. About 40-minutes later, the patient returned to sinus rhythm (141 beats/min), blood pressure was 70/40-mmHg. The patient was transferred to the intensive care unit to continue the treatments such as fluid infusion, organ protection, mild hypothermia brain protection, prevention of epilepsy, correction of electrolyte disorders etc. Despite active rescue and treatments, the patient still died 6 days later due to a recurrence of cardiac arrest.
  • Zhou Boya, Wang Aihua, Yuan Sisi, Feng Xin
    Adverse Drug Reactions Journal. 2020, 22(2): 107-108. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.010

     A 60-year-old female received recombinant human interferon α2b capsule for vaginal foams 800 000 U/capsule every night by putting it in the vaginal vault for cervical human papillomavirus infection. Five hours after the first administration, she developed influenza-like symptoms such as headache, muscle ache, fatigue, and fever (38.5-38.9 ℃). Twenty-four hours later, another capsule was used again and above-mentioned symptoms persisted. Then the drug was stopped and physical cooling was given. On day 2 of drug withdrawal, the patient′s temperature decreased to 37.5-37.9 ℃. On day 3, her headache, muscle ache, and fatigue alleviated. On day 4, her temperature returned to normal and her influenza-like symptoms disappeared.

  • 论著
    Jin Jianmin;Zhang Husheng;Chen Dongning
    . 2008, 10(3): 168-5.

    Objective: To study the tolerance and safety of moxifloxacin in the treatment of elderly patients with communityacquired lower respiratory tract infections. Methods: One hundred and ninetyseven patients with communityacquired lower respiratory tract infections [104 men, 93 women, average age (73±11) years] were included in the study. They received IV moxifloxacin 400 mg/d for 7~10 days, followed by oral moxifloxacin 400 mg/d for 3~6 days. The duration of treatment was about 2 weeks. The tolerance and safety of moxifloxacin were observed. Results: Twoweek therapy was accomplished in 194 patients, and the therapy was discontinued in 3 patients because of neuropsychic disorders and rash. Of the 194 patients, 135 cured perfectly, 42 improved significantly, and 17 improved. The adverse reactions occurred in 24 patients, and the main reactions were mild neuropsychic and gastrointestinal disorders. Conclusion:Moxifloxacin is a relatively effective and safe agent for treating communityacquired lower respiratory tract infections. It is well tolerated to elderly patients.

  • 安全用药
    . 2004, 6(3): 161-163.
    静脉输液不当可引起循环超负荷、血液稀释、病原微生物污染、栓塞、静脉炎、营养物质补充不当及诱发药物过量反应等。患者病情、配制操作、配制程序、伍用药物、输液溶媒及输液速度等因素均是静脉输液应用中应认真对待的问题。静脉输液相关不良反应多,应加强安全注射的教育和管理。
  • 调查研究
    Wang Ting;Fang Juanjuan
    . 1999, 1(1): 22-25.
    Objective: To analyse the adverse drug reactions induced by antiinfective drugs. Methods: Reported cases of adverse drug reactions related to antiinfective drugs were collected from Chinese Pharmaceutical Abstracts (1994September, 1998), and arranged in order according to the number of cases for analysing. Results: Penicillins, quinolones and cephalosporins were in the first three places; and serious adverse drug reactions amounted to 535 cases, chief among the reactions were allergic shocks and functional damage to liver and kidney. Conclusion: Rational use of antiinfective drugs should be strengthened in the clinical practice in order to prevent and reduce the occurence of adverse drug reactions.
  • Zhang Jiaxing;Wang Zhongyuan;Xie Juan;Chen Qi;Gao Ling;Luo Lei;Li Lianhua;Xiong Shijuan;Sheng Changcheng
    . 2015, 17(1): 3-9.
    ObjectiveTo systematically evaluate the effectiveness and safety of pantoprazole sodium(PAN) and omeprazole(OME) treatments in patients with duodenal ulcer.Methods"Panto-prazole sodium", "omeprazole", "ulcer", and "randomized controlled trial" were selected as key words and PubMed, Embase, the Cochrane Library, VIP, CNKI, and Wanfang databases from the inception to September 2014 were searched. Randomized controlled trials (RCT) on comparison of PAN and OME treatments in patients with duodenal ulcer were selected. According to the intervention measures, the subjects were divided into the PAN group and the OME group. The medication comprised oral and intravenous administration. The Meta-analysis was performed using RevMan 5.2 software. The outcomes included the ulcer healing rate, the pain relief rate and time, the incidence of adverse drug reactions, and the recurrence rate at six months. ResultsA total of 17 RCTs involving 1 847 patients were entered, including 1 008 in the PAN group and 839 in the OME group. The patients in 12 RCTs received drugs by mouth and the patients in other 5 RCTs received intravenously and the Meta-analysis was performed respectively. The ulcer healing rates in patients with 2 or 4 weeks of oral PAN treatment, the pain relief rates in patients with 1, 2 or 4 weeks of oral PAN treatment were compared with those in patients with oral OME treatment at the same period and the differences were not significant. The pain relief rates in patients with 3 days of oral PAN treatment were higher than those in patients with 3 days of oral OME treatment [relative risk (RR)=1.27, 95% confidence interval(CI): 1.03-1.57, P=0.03]. The differences of the pain relief time, the incidence of adverse drug reactions, and the recurrence rates of six months between the patients with oral PAN treatment and the patients with OME treatment were not significant. The differences of the ulcer healing rates, the pain relief rates, the incidence of adverse drug reactions, and the recurrence rates of six months between the patients with intravenous PAN treatment and the patients with intravenous OME treatment were not significant.ConclusionBoth PAN and OME are safe and effective drugs for duodenal ulcer treatment.
  • Liao Juan, Ma Yuanji, Tang Hong
    Adverse Drug Reactions Journal. 2022, 24(4): 192-196. https://doi.org/10.3760/cma.j.cn114015-20211124-01187
    Objective To understand the management status of suspected unexpected serious adverse reaction (SUSAR) reports in clinical trial sites in China after the release of the 2020 edition of Good Clinical Practice (new GCP). Methods The serious adverse event (SAE)/SUSAR reporting requirements files in each site as of June 30, 2021 were downloaded after logging into the "summary of SAE/SUSAR reporting requirements in national sites under the new GCP" platform on an APP named Yaoyanshe (药研社). The requirements on SUSAR reporting management from above files in each site were extracted, including the acceptance process of the SUSAR reports submitted by the clinical trial sponsor and the processing process after receiving the reports (whether the investigator is required to sign for reading and evaluating the SUSAR reports, the time limit and form/format for the investigator to submit the SUSAR reports to the clinical trial institution and the ethics committee, and the processing method in the clinical trial institution and the ethics committee after receiving the SUSAR reports). The collected data were analyzed by descriptive statistics. Results The SUSAR reporting requirements files in the analysis were collected from 194-sites in 30 provincial administrative regions across the country. In the acceptance process of SUSAR reports submitted by the sponsor, 69.6% (135/194) of the sites required the investigators to sign for reading and evaluating the SUSAR reports, 24.2% (47/194) required the sponsor to submit the SUSAR reports to the clinical trial institution and/or ethics committee, and 6.2% (12/194) had no clear requirements. In the processing process after receiving the reports, 85.1% (165/194) of the sites required the investigators to submit the SUSAR reports to the clinical trial institution and the ethics committee at the same time, 13.4% (26/194) only required the investigators to submit them to the ethics committee, and 1.5% (3/194) had no clear requirements. Except that 1.0% (2/194) sites had no explicit requirements, for lethal/life-threatening SUSAR, 94.3% (183/194), 2.6% (5/194), and 2.1% (4/194) sites required investigators to submit the reports within 7 days, monthly, and quarterly, respectively. Except that 2.6% (5/194) sites had no explicit requirements, for non lethal/life-threatening SUSAR, 54.6% (106/194), 12.9% (25/194), 29.4% (57/194), and 0.5% (1/194) sites required investigators to submit the reports within 15 d, monthly, quarterly, and semiannually, respectively. Requirements on the form/format of SUSAR reports for investigators in submitting were different among sites. Only 12.9% (25/194) of the sites required the ethics committee to filing or meeting in handling of SUSAR reports, and 5.7% (11/194) required feedback on the handling opinions from the ethics committee. Conclusions Requirements on SUSAR reporting are of great differences among sites. The management of SUSAR reports in some sites does not meet the requirements in the new GCP, which may affect the risk control in clinical trials and need to be further standardized.
  • 综述
    Sun Zhenxiao;Yu Xiangfen
    . 2014, 16(5): 294-3.
    Rabbit syndrome(RS) is a tardive extrapyramidal syndrome associated with prolonged use of drugs, especially antipsychotics. The incidence of RS induced by antipsychotics ranged from 1.5% to 4.4%. The clinical characteristics of RS is fast and rhythmic involuntary movement of oral and masticatory muscles. The mechanism of RS may be associated with imbalance of the cholinergic and dopaminergic neurotransmission in the basal ganglia. RS should be distinguished from tardive dyskinesia. About treatment of RS, anticholinergic agents is the first choice. Some patients switching to an atypical antipsychotic with high anti-cholinergic properties is another treatment strategy.
  • 中毒救治
    Wang Dixin;Li Suyan
    . 2007, 9(5): 341-346.
    Thallium is a very toxic heavy metal,the lethal dose for adults is approximately 12 mg/kg.The exact mechanism of thallium poisoning is unclear;however,it may competitively inhibit potassium action,bind to sulfydryl group of proteins and enzymes,and form insoluble complexes with riboflavin.The triad of gastroenteritis,polyneuralgia,and alopecia is regard as the classic syndrome of thallium poisoning.Gastrointestinal symptoms,such as nausea,vomiting,and abdominal pain,occur early.Neurologic symptoms are pain and paresthesias of the lower extremities,convulsions,and coma.Hair loss may appear within 1 to 3 weeks after thallium poisoning.Other signs and symptoms are skin eruptions,renal injury,tachycardia and visual disturbances,etc.Death may result from respiratory failure.A 24-hours urine thallium concentration is the most accurate way to assess thallium poisoning.If urine thallium concentration is more than 0.3 mg/L,it is of diagnostic significance.Differentiation of thallium toxicity fr…更多om Guilliam-Barre syndrome,lead poisoning,and arsenic toxicity should be made.Oral thallium poisoning may be treated with activated charcoal,magnesium sulfate,Prussian blue,etc.The usual dose of Prussian blue is 250 mg/kg daily,given in 4 divided doses by mouth.Hemoperfusion has been reported to be effective in eliminating absorbed thallium.
  • 专题讲座
    . 2004, 6(5): 323-329.
  • 病例报告
    Xu Xiaojuna;Sun Chunhuab
    . 2009, 11(2): 133-2.
    A 17yearold boy with chronic granulocytic leukemia was treated with imatinib 400 mg twice daily for about 4 months, but this had no effect. Later, imatinib was changed to dasatinib 70 mg twice daily. About one month and a half later, the patient initially presented with body temperature of 39.2℃, followed by generalized myalgia, ostalgia, and arthralgia. After treatment with 1 rectal indometacin 50 mg suppository thrice daily and an IV infusion of dexamethasone 2.5 mg, his pains lessened. Dasatinib was continued for the clinical needs of the patient. His pains reappeared, and rectal indometacin suppositories were given.
  • 病例报告
    . 2005, 7(2): 135-136.
  • 监测交流
    . 2006, 8(1): 59-61.
  • Chen Xintong, Zhuang Wei, Wang Yawei, Zhou Jingyan, Lin Xiaolan
    . 2016, 18(4): 255.
    ObjectiveTo investigate the status and influencing factors of medication error (ME) in traditional Chinese medicine.MethodsME reports in Xuanwu Hospital of Capital Medical University from January 1st, 2014 to November 31st, 2014 were collected from International Network for the Rational Use of Drugs (INRUD).Of them, ME reports of traditional Chinese medicine were selected. Category, content, persons who triggered the ME, triggering factor, persons who found the ME were analyzed descriptively.ResultsA total of 863 ME reports were collected and 477 reports (55.27%) related to traditional Chinese medicine were selected. Of the 477 ME reports, 180 reports(37.74%) were related to Chinese patent drugs and 297 reports (62.26%) were related to Chinese herbal drugs. Four hundred and seventy-seven patients were reported in the 477 ME reports. Of the 477 patients, 218 patients (45.70%) were male, 221(46.33%) were female, and in 38 (7.97%) the sex was not clear. Their ages were from 4 to 92 years and 113 patients(23.69%) were ≥66 years old. Of the 477 MEs, 83 cases (17.40%) belonged to category A, 389 cases(81.55%) belonged to category B, 5 cases(1.05%) belonged to category C, and none of the patients were hurt. The dosage errors in content of MEs ranked the first and accounted for 31.03% (148/477), errors of drug category ranked the second and accounted for 12.16% (58/477). In persons who triggered the ME, doctors accounted for 68.13% (325/477), pharmacists accounted for 23.06% (110/477). Four hundred and sixty-seven cases of the 477 MEs were caused by a factor, 28 cases were caused by 2 kinds of factors, 10 cases were caused by 3 kinds of factors, and a total of 525 person-time MEs were reported. Lack of professional knowledge of traditional Chinese medicine was the first triggering factor and accounted for 24.57%(129/525), fatigue was the second triggering factor and accounted for 17.72%(93/525). The main persons who found the MEs were pharmacists with primary and medium professional titles and accounted for 61.49% (289/470) and 36.81% (173/470), respectively. ConclusionsMEs related to traditional Chinese medicine accounted for half of all MEs and most of them were related to Chinese herbal drugs. The main persons who triggered the MEs were doctors and pharmacists. The main triggered factors were lack of professional knowledge of traditional Chinese medicine and fatigue. Pharmacists play an important role to find and correct ME related to traditional Chinese medicine in time for protecting the patient′s medication safety.
  • Qin Qiong, Xue Ling, Zhou Ling
    Adverse Drug Reactions Journal. 2020, 22(10): 585-586. https://doi.org/10.3760/cma.j.cn114015-20191210-00996
    A 66-year-old female patient with rheumatic heart disease underwent mitral valve replacement and coronary artery bypass grafting under general anesthesia. After the operation, she received warfarin 1.25-mg once daily for anticoagulation, intravenous infusions of imipenem and cilastatin sodium and teicoplanin for anti-infection. After 9 days of treatments, the patient developed a large area of skin rash with itching on her abdomen, chest, and back. She was diagnosed as having exanthematous drug eruption. The above-mentioned drugs were stopped and low molecular weight heparin was given by subcutaneous injection. Three days after the drug withdrawal, her rash was improved markedly. She was given warfarin again due to her illness. Ten days later, the rash on her chest and back recurred. Warfarin was stopped again and replaced by low molecular weight heparin. At the same time, oral loratadine and external application of calamine lotion were given. The rash was improved 3 days after warfarin was stopped again. Skin allergic reaction did not recur after switching to warfarin produced by another manufacturer.
  • Wang Wenjin, Chen Wenhui, Wu Shaolin
    Adverse Drug Reactions Journal. 2020, 22(7): 430-431. https://doi.org/10.3760/cma.j.cn114015-20190121-00068
    An 84-year-old male uremic patient treated with maintaining hemodialysis received IV infusion of piperacillin sodium and sulbactam sodium 5 g dissolved in 0.9% sodium choride 100 ml twice daily for pneumonia. The patient developed fever (the highest body temperature was 39.6-℃) on the night of medication, and itchy skin the next day. On the 4th day, patchy erythema appeared on the skin of his trunk and limbs, accompanied by erosion, exudation, and tenderness. Nikolsky′s sign was positive. Toxic epidermal necrolysis was diagnosed. Piperacillin sodium and sulbactam sodium were discontinued and replaced by moxifloxacin; the original dialysis mode was changed to continuous veno-venous hemodiafiltration combined with hemoperfusion once every other day on the basis of conventional therapy of glucocorticoids combined with low-dose immunoglobulin; and skin care and supportive treatment were strengthened at the same time. After 3 weeks, the skin lesions of the patient basically recovered.
  • Cai Jun, Cui Wenxia, Gao Lei, Shi Xiaoting, Pan Fenghui, Hu Yun
    Adverse Drug Reactions Journal. 2020, 22(9): 505-510. https://doi.org/10.3760/cma.j.cn114015-20191120-00928

    To explore the clinical characteristics of perioperative euglycemic diabetic ketoacidosis (euDKA) induced by sodium‑glucose cotransporter 2 (SGLT2) inhibitors. Methods The case reports of perioperative euDKA caused by SGLT2 inhibitors published up to June 30, 2019 were collected by searching the relevant databases and the following information of patients including demographic characteristics, types of diabetes, use of SGLT2 inhibitors, onset time and clinical manifestation of euDKA, the blood glucose and pH, serum bicarbonate and anion gap, β-hydroxybutyric acid and ketone body concentration in urine when diagnosing euDKA, predisposing factors of euDKA, as well as the treatments and outcomes were collected. The clinical characteristics of perioperative euDKA induced by SGLT2 inhibitors were analyzed descriptively. Results A total of 27 patients (from 20 articles) were collected, including 13 males and 14 females with an age of (58±12) years; 26 patients were with type 2 diabetes mellitus and 1 with type 1 diabetes mellitus. Of them, 15 cases were treated with canagliflozin, 6 cases were treated with dapagliflozin, and 6 cases were treated with empagliflozin; the onset time of euDKA was 10 hours to 10 days after operation and within 3 days after operation in 21 cases (77.8%); 24 cases had similar symptoms as ketoacidosis and 3 cases had no obvious symptoms; the blood glucose was (9.5±2.2) mmol/L when diagnosing euDKA and the other laboratory test results were similar to those of ketoacidosis. The main factors inducing euDKA were operation and low carbohydrate diet. After the occurrence of euDKA, all patients received insulin and rehydration the- rapy, and then 26 cases (96.3%) got better and 1 (3.7%) died. Conclusions The perioperative euDKA mainly occurred within 3 days after operation. The main inducing factors of euDKA were operation and low carbohydrate diet. After insulin and rehydration therapy, most patients had a good prognosis.

  • Yang Meimei, Fan Ping, Gao Yangyang, Xu Ting
    . 2016, 18(6): 466.
    A 44-year-old female patient with acute appendicitis received an IV infusion of piperacillin sodium and tazobactam sodium 4.5 g once every 8 hours. No other combined drugs were given at the same time. The patient′s alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels were 27 U/L and 21 U/L, respectively before treatment. Three days later, the patient′s abdominal pain was alleviated, but her ALT and AST levels increased to 159 U/L and 124 U/L, respectively. It was considered that the liver injury was induced by piperacillin sodium and tazobactam sodium. The drug was stopped at that day and IV infusion of cefoxitin sodium 2 g+0.9% sodium chloride 100 ml twice daily and magnesium isoglycyrrhizinate injection 0.1 g+5% glucose injection 250 ml once daily were given. On the 5th day of piperacillin sodium and tazobactam sodium were withdrawn, the patient′s ALT and AST levels were 65 U/L and 32 U/L and on the 42th day, 31 U/L and AST 23 U/L, respectively.
  • 监测交流
    . 2006, 8(5): 387-388.
    目的:探讨药品不良反应(ADR)成本测算的研究模式和意义。方法:采用回顾性方式,将收集的ADR病例统计分析后分为3组,A组:因ADR住院治疗和住院期间发生ADR导致住院时间延长者;B组:发生ADR但未导致住院或住院时间延长采用药物治疗者;C组:发生ADR但停药后自愈者;分别对3组病例给予不同层面的成本测算。结果:利用项目法和人力资本法可以分别测算出3组ADR病例造成的直接和间接成本,忽略隐性成本。继而测算出个人和医疗保险分别承担的比例,最终可结合现行医药卫生改革趋势和社会经济发展状况,进行敏感性分析和预测。结论:通过上述ADR的成本测算模式,可加强对ADR相关费用的系统监测与分析,有效地改善整个医疗机构的成本效益,为指导临床合理用药,减少医药费用的支出提供科学依据。
  • Chen Kuixia, Pan Dan, Li Li, Dou Nina, Zhao Kexin
    Adverse Drug Reactions Journal. 2020, 22(9): 537-538. https://doi.org/10.3760/cma.j.cn114015-20190904-00734
     A 77‑year‑old male patient received intravenous infusion of levofloxacin 0.5 g for preventing infection before transrectal prostate biopsy. Three hours after the infusion finished, erythema with pruritus appeared on his trunk, buttocks and limbs. Two days later, the patient developed fever, aggravated rash, and large area of blisters. Three days later, the blisters were broken and Nikolsky sign was positive. Toxic epidermal necrolysis was diagnosed, which was considered to be related to levofloxacin. Symptomatic treatments including combination use of glucocorticoid and human immunoglobulin and skin wound care were given. Fifteen days later, his rash completely subsided and the skin wound healed basically.
  • 调查研究
    Zhang Jingli;Zhao Xia;Ma Wenhui;Wang Lihong;Wang Guizhen
    . 2007, 9(1): 21-24.
    Objective: To investigate the rationality of prophylactic antibacterial use in the perioperative period in order to elevate the levels of rational drug use. Methods: Nine hundred and forth-eight inpatients receiving surgical procedure were investigated and analysed retrospectively for prophylactic antibacterial use in March, 2006. Results: Of the 1 841 times of prophylactic antibacterial use in 948 cases, 1 039 (56.44%) were rational,189 (10.27%) basically rational, and 613 (33.29%) irrational. The patterns of irrational drug use were manifested in the following forms: overlong duration of administration, inappropriate timing of administration, overdose, incorrect choice of drugs, inappropriate indication, less frequency of administration, and so on. Conclusion: There were some patterns of irrational prescribing in the prophylactic antibacterial use in the perioperative period; therefore, it is necessary to carry out "Guidelines on Clinical Use of Antimicrobials" in order to avoid the inappropriate use of antibacterials
  • 病例报告
    . 1999, 1(3): 189-189.
  • Hu Lihua, Meng Yao, Wang Xiaoling
  • 安全合理用药
    Li Ran;Wang Rui
    . 2008, 10(4): 0-0.
    Colistin is a polypeptide antibiotic that was used in 1960s for the treatment of infections caused by Gramnegative bacteria. Colistin was almost abandoned in the 1980s because of the reported toxicity and the development of new antibacterials. However, the increased incidence of infections by multidrug resistant Gramnegative bacteria has motivated the reintroduction of colistin into the clinical practice. Several studies indicate that colistin is an effective agent for treating multidrug resistant Gramnegative bacterial infections, especially for infections (such as pneumonia, bacteremia, prosthesis arthrosis infection, and urinary infection) caused by multidrug resistant baumanii and pseudomonas aeruginosa, and the clinical response rate is 66.7%~87%. The main adverse reactions of colistin are nephrotoxicity and neurotoxicity. The incidence rate of nephrotoxicity to colistin was 26.1% in the early years, and was 14% in recent studies. No neuromuscular blockade was found in the recent 15 years. At present, colistinresistant Gramnegative strains develop due to its wide use in clinical practice. Therefore, attention should be paid to the clinical colistin use as follows: the dosage, administration, duration, combination with other nephrotoxic drugs, and rational and safe use in patients with renal insufficiency.
  • Ye Zhen, Lyu Xin, Yu Zhe, Wei Jilin, Cheng Cheng, Xue Hui, Deng Xu
    Adverse Drug Reactions Journal. 2021, 23(10): 548-550. https://doi.org/10.3760/cma.j.cn114015-20210118-00073
    A 73-year-old male patient with diabetic mellitus complicated with peripheral vascular lesions and neuropathy received sarpogrelate on the basis of previous treatments with ticagrelor, nifedipine controlled-release tablets, candesartan cilexetil, metoprolol tartrate sustained-release tablets, and isosorbide mononitrate dispersible tablets for aggravated numbness and coldness of hands and feet with lower limb pain. Oral mucosal bleeding occurred after 12 days of treatments and platelet count (PLT) was 7×109/L after 16 days of treatments. Before sarpogrelate was added, PLT was 229×109/L. The patient had taken ticagrelor or sarpogrelate alone in the past, no bleeding occurred, and the patient had no history of abnormal blood cells and platelets. Considering that the thrombocytopenia was caused by the combination use of sarpogrelate and ticagrelor, the 2 drugs were stopped, 300-ml of platelet plasma was given that day, and aspirin enteric-coated tablets 100-mg orally once daily was given on the second day. Nineteen days later, the PLT recovered to 187×109/L。
  • 病例报告
    Zhang Na
    . 2008, 10(2): 146-2.
    A 78yearold woman with cerebral infarction received IV cinepazide maleate injection 160 mg once daily. On day 3, the woman experienced a fever; her WBC count decreased from 7.32×109/L to 2.3×109/L; neutrophil count decreased from 6.14×109/L to 1.7×109/L. Cinepazide maleate injection was withdrawn immediately, and berbamine and batilol were given. Two days later, her temperature fell to normal, and laboratory testing showed a WBC count of 2.6×109/L with N 20×109/L. Two weeks later, her WBC and neutrophil counts retured to normal limits. A followup period lasting two months showed that her blood routine tests remained normal.
  • 药物评介
    . 2004, 6(5): 320-322.
  • 病例报告
    . 2004, 6(6): 413-414.
  • 安全用药
    . 2004, 6(4): 243-246.
    5-羟色胺综合征(serotoninsyndrome熏SS)是一种罕见的,由抗抑郁药所致的特异的药物并发症。本文对可导致SS的药物以及SS的临床表现、诊断、治疗、预防作一详细介绍,以引起临床医务人员的注意。
  • Wang Baohua, Yu Dan, Zhu Xu, Zhao Limei
    Adverse Drug Reactions Journal. 2021, 23(2): 102-103. https://doi.org/10.3760/cma.j.cn114015-20200724-00806
    A 45-year-old female patient received drospironone and ethinylestradiol tablets (Ⅱ) (containing drospirone 3-mg and ethinylestradiol 0.02-mg in each tablet) orally, once daily after endometrial polypectomy. On the 11th day of medication, the patient developed headache, movement disorder of left limb, and unclear speech without obvious inducement and CT angiography of the head showed cerebral infarction in the right parietal lobe and temporal lobe, which was considered to be related to drospironone and ethinyl estradiol. Drospirone and ethinylestradiol tablets (Ⅱ) was stopped. The treatments such as improving the symptoms of brain injury, reducing intracranial pressure, lowering blood lipids, supplementing iron and potassium, and oxygen inhalation were given. After 11 days of treatments, her movement function of the left limb was improved but the rest had no significant change.
  • Adverse Drug Reactions Journal. 2020, 22(3): 170-172. https://doi.org/10.3760/cma.j.cn114015-20200219-00134
    新型冠状病毒肺炎疫情防控期间,大力推进互联网医院建设,对病情稳定的慢性病复诊患者提供线上药学服务,不仅可降低患者交叉感染的风险,还可保障患者治疗药物管理得以持续。本文从福建医科大学附属第一医院的互联网医院平台运行实际出发,介绍了互联网药学服务特色以及新思路,可为当下及未来互联网医院药学服务发展提供借鉴和参考。
  • 调查研究
    Cheng Jinghua;Cai Haodong
    . 2000, 2(1): 15-19.
    Objective: To approach the clinical manifestations and pathogenesis of adverse reactions caused by Zhuangguguanjie Wan (ZW), a ready-prepared Chinese medicine. Methods: 156 ZW-induced ADR cases in 1992-1998 were collected and reviewed from CBM, Beijing Centre for ADR Monitoring and Beijing Ditan Hospital. Results: ZW is generally for the aged and the most common manifestation is live damage characterized by cholesta-sis, which would be related with improper pattern identification, individual differences and toxicity of some ingredients in ZW. Conclusion: ZW administration needs liver function tested regularly because liver damage might be produced. It is suggested that ZW formula be readjusted.
  • 论著
    Liu Sha①;Du Guiyou②;Li Li②;Xao Yongqing②
    . 2006, 8(3): 169-174.
    Objective: To study the mechanism of nephrotoxicity from aristolochic acid-I(AA-I)in terms of toxicokinetics. Methods: AA-I extracted from Aristolochia Fangchi (containing 80.5% of AA-I)was orally administered to male Wistar rats in a dose of 125、62.5、15.2mg/kg respectively,and the samples (plasm,bile,urine,faeces and organs) were collected in accordance with experimental design. AA-I and its metabolite aristololactam-I (AL-I) in samples were determined by HPLC method. Meanwhile,the changes in renal function and pathology were examined. Results: The metabolism of AA-I in a toxic dose was correspondence to two-compartment model.The main toxicokinetics parameters of AA-I in a dose of 125 and 62.5mg/kg were as follows respectively: T1/2α1.03h、0.45h,T1/2β6.10h?6.54h,CL 3.021.41 ml/(min·kg),AUC 33.10、35.22 μg/(ml·h),Tpeak 0.62、1.35h. AA-I and AL-I were distributed in all organs,and the acumulation of AA-I and AL-I in organs was obvious. Compared with the blank group,BUN and Cr in middle and high dosage group were obviously high(P< 0.01). The histological and pathological examination showed that crescent formation of glomerular capsule and necrosis of renal tubule in high dosage group. Conclusion: The metabolism of Aristolochia Fangchi extract in a toxic dose was correspondence to two-compartment model,and the distribution of AA-I and AL-I was wide and the accumulation of them was specific. The severity of renal impairment of rats was especially related to the concentration of AL-I in kidney.
  • ADR监测与防治
    . 2000, 2(3): 169-171.
  • 病例报告
    Li Zhuojun;Liu Ji;Liu Jiaming
    . 2010, 12(2): 141-2.
    A 39yearold women with an upper respiratory tract infection received an IV infusion of clindamycin, ribavirin, and Shuanghuanglian for two days. However, these had no obvious effect. And they were replaced by cefoperazone and asarone. She was administered an IV infusion of cefoperazone 2 g in 5% glucose 250 ml without adverse reactions, followed by an IV infusion of asarone 16 mg dissolved in 5% glucose 250 ml. About 5 minutes after asarone infusion start, the patient suddenly developed chest distress, dyspnea, convulsion. Subsequently, she experienced confusion, respiratory and cardiac arrest. Finally, the patient died desipite resuscitation attempts.
  • Zhang Xiaoli, Zhou Zhongjiang, Zheng Ping
    Adverse Drug Reactions Journal. 2021, 23(3): 145-147. https://doi.org/10.3760/cma.j.cn114015-20200530-00609
    A 63-year-old male patient with glucose-6-phosphate dehydrogenase (G6PD) deficiency and type 2 diabetes mellitus received long-term use of glimepiride (2-mg once daily) and no adverse reactions occurred. He underwent percutaneous coronary intervention (PCI) followed by drug-eluting stent (DES) implantation because of acute inferior myocardial infarction. After the operation, dual antiplatelet therapy with oral aspirin enteric-coated tablets (100-mg once daily) and ticagrelor (90-mg twice daily) was given. Clinical pharmacists participated in the ward round and learned that the patient had a history of G6PD deficiency. After consulting the list of unsafe drugs for G6PD deficiency patients, the pharmacists found that glimepiride and aspirin were high-risk drugs that could induce hemolysis in G6PD deficiency patients. It was believed that the combination of the 2 drugs might increase the patient′s risk of hemolysis. They recommended that glimepiride should be discontinued and routine aspirin after PCI and DES should be continued. The physician adopted the pharmacists′ advice and the hypoglycemic agent was replaced by metformin hydrochloride. The patient recovered soon after surgery. At a 3-month follow-up, no hemolytic reaction occurred in the patient.
  • 病例报告
    . 2002, 4(2): 125-126.
  • Liu Jiyu, Zhao Li, Zou Hejian, Xue Yu
    Adverse Drug Reactions Journal. 2022, 24(10): 534-539. https://doi.org/10.3760/cma.j.cn114015-20211227-01302
    Objective To explore the clinical characteristics of rituximab-related progressive multifocal leukoencephalopathy (PML) in patients with rheumatoid arthritis (RA). Methods The relevant domestic and international databases (as of November 2021) were searched and case reports on PML in RA patients treated with rituximab were collected. Clinical data such as gender, age, underlying disease, use of rituximab, combination drugs, time to onset of PML, clinical manifestations, results of ancillary examinations(imaging, cerebrospinal fluid), intervention and prognosis were extracted and analyzed descriptively. Results A total of 10 patients were enrolled in the study, including 1 male and 9 females, aged from 51 to 83 years with an average of 66 years. All of the patients were suffering from moderate to severe RA, 9 of which had a disease duration of ≥3 years and 1 had no disease duration record. The usage and dosage of rituximab in the 10 patients were in accordance with the instructions, and all the patients received combined medication with conventional synthetic disease-modifying anti-rheumatic drugs or glucocorticoids. The time from the last dose of rituximab to the onset of PML was recorded in 9 patients, which were 2-8, 16, and 18 months in 7, 1, and 1 patient respectively, with a median time of 6 months. Clinical symptoms were recorded in 6 patients, mainly including ataxia, speech disorders, cognitive impairment, and focal sensory deficits, etc. Six patients had head magnetic resonance imaging, and all of the results were consistent with the imaging changes of PML. Four patients had cerebrospinal fluid anti-John Cunningham virus test, which were positive for viral DNA in 3 patients and negative in 1 patient (the patient was diagnosed with PML by brain tissue biopsy). After the diagnosis of PML, 1 patient received no intervention, 3 had no record of intervention measures, 5 were treated with mefloquine and mirtazapine alone or in combination (2 of which were combined with plasma exchange and 1 with glucocorticoids), and 1 was treated with mirtazapine and nitrofurantoin in combination. Seven patients died due to ineffective treatment, 2 survived but had severe neurological sequelae, and the final outcome of 1 patient was not reported. Conclusions Rituximab-related PML mostly occurs 2 to 8 months after the last application of the drug, which has similar clinical manifestations and imaging to that due to other causes and usually aggravate progressively with a high mortality rate. The survivors may have severe neurological sequelae.
  • 调查研究
    CAI Haodong
    . 1999, 1(1): 36-40.
    Objective: To analyse the causes of the adverse reactions induced by Shuanghuanglian and to study the way of their prevention and treatment. Methods: This article summarized 179 cases of the adverse reactions caused by shuanghuanglian in recent years, and analysed the classification, clinical characteristics and causes of the adverse reactions induced by Shuanghuanglian . Results: The adverse reactions of Shuanghuanglian were related to the quality of the preparation, the application of the drug and the individual factors. Conclusion: To pay great attention to the adverse reactions of shuanghuanglian .
  • 调查研究
    Wen Wei① Ji Liwei② Zhang Xinchao①
    . 2006, 8(2): 105-109.
    Objective: To analyse the causal factors of acute hepatic injury induced by intravenous infusion of amiodarone. Methods: The clinical feature, primary disease, indications of amiodarone, characteristics of hepatic injury, concomitant medicines and prognosis of patients were analyzed in 15 cases. Of the cases 2 were the inpatients of our hospital in 2005, and 13 were collected from foreign and domestic medical journals between 1998 and 2005. The dosage of intravenous amiodarone was (1073.3±412.7)mg, the duration of administration was (24±7.9)h. Results: The peak of AST was (5283±5219)U/L and ALT was(4075±3508)U/L. The liver function was improved one day after discontinuation of intravenous amiodarone, and the liver function of 7 cases who adopted oral amiodarone after stopping intravenous amiodarone continued to improve. Conclusion: Acute hepatic injury induced by intravenous amiodarone is uncommon, and it may be in associationwith polysorbate 80, as a cosolvent, contained in amioidarone injection.
  • Yang Chunsheng, Meng Yumei, Jiang Wenyong, Wang Hongna, Liang Jinshan, Liu Yanmei, Kan Chunna, Zhu Xueliang, Liu Yu, Yu Jianpeng
    Adverse Drug Reactions Journal. 2021, 23(5): 279-280. https://doi.org/10.3760/cma.j.cn114015-20201130-01191
    A 65-year-old female patient with chronic renal failure undergoing continuous hemo- dialysis received an IV infusion of cefmenoxime 1 g twice daily for acute pancreatitis. The values of prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (APTT) were within the normal range before treatment. After 11 days of treatment, the patient developed multiple ecchymoses on the skin and bleeding from the venipuncture site which was not easily stopped. The reexamination of coagulation function showed PT 127-s, INR 10.72, and APTT 86-s. Coagulation dysfunction was considered and an IV infusion of leukocyte-reduced fresh-frozen plasma 150-ml was given. Examination of coagulation function next day showed PT 101-s, INR 8.49, and APTT 65-s. Mixing study for evaluation of abnormal coagulation testing showed that PT and APTT could be corrected, suggesting coagulation factor deficiency. Blood coagulation disorders caused by cefmenoxime was considered. Then the drug was discontinued and switched to amoxicillin sodium and clavulanate potassium, and a subcutaneous injection of vitamin K1-10-mg was given once daily. Three days after the drug withdrawal, her coagulation function returned to within the normal range (PT 15-s, INR 1.19, APTT 36-s).
  • 病例报告
    Lan Anjie;;Chu Yanqi;Liu Lihong;Yuan Fang
    . 2010, 12(2): 137-2.
    A 69yearold women received an IV push of amiodarone 150 mg for arrhythmia, paroxysmal supraventricular tachycardia, and a heart rate of 166 beats/min. Thirty minutes later, the patient developed sinus bradycardia and hypotension. Her heart rate was 35 beats/min and blood pressure was 81/50 mm Hg. She was undergone temporary pacemaker. Meanwhile fluid supplementation and an IV dopamine were given. One hour later,her symptoms relieved. She was treated with an IV infusion of amiodarone 300 mg diluted in 5% glucose 50 ml via pump at a rate of 0.6 mg/min for intermittent episodes of tachycardia. The next day,her laboratory tests revealed the following values:ALT 1 770 U/L,AST 1 360 U/L,TBil 130.20 μmol/L, DBil 98.40 μmol/L; PT 17.3 s, INR 1.45. Amiodarone was stopped and she received symptomatic and supportive treatment. One week later,her symptoms improved.
  • 病例报告
    Bao Zhongying①;Yang Hong②;Liu Meisheng①
    . 2007, 9(5): 373-374.
    A 62-year-old woman with acute bacillary dysentery was administered with IV fleroxacin and glocuse injection 100 ml(0.4 g)once daily.On day 3,she developed a generalized aching pain of muscles and joints.A physical examination showed the left knee and ankle joint swelling,tenderness on the lateral part of medial head of gastrocnemius muscle,and pain occurring in joint motion.A B-mode ultrasonography revealed hydrarthrosis of the left knee.And a MRI showed her left knee anterior cruciate ligament injury,hydrarthrosis,periarticular soft-tissue swelling.Laboratory test results were as follows:erythrocyte sedimentation rate 130 mm/h,C-reactive protein 42 mg/L.Fleroxacin was discontinued,and she was given articular immobilization and local physiotherapy.The repeated B-mode ultrasonography showed her left knee joint was restored to normal status.Three months later,her levels of erythrocyte sedimentation rate and C-reactive protein normalized on re-examination.
  • 安全用药
    . 2005, 7(1): 23-26.
    本文概要介绍了可诱发青光眼的药物,并对其诱发青光眼的作用机制和临床干预进行探讨,旨在加深医务人员对药源性青光眼的认识,提高临床合理用药和诊断水平,避免或减少误诊误治的发生。
  • Li Wei, Li Quanzhi, Li Quan, Wang Zhixin, Xu Xiaojie, Wang Ru, Deng Wei
    Adverse Drug Reactions Journal. 2022, 24(11): 578-583. https://doi.org/10.3760/cma.j.cn114015-20220714-00636
    Objective To compare the efficacy and safety of continuous subcutaneous insulin analogues infusion (CSII) and multiple daily insulin analogues injection (MDII) in fracture patients with type 2 diabetes mellitus (T2MD) during the perioperative period. Methods The medical data of patients with lower limb fracture complicated with T2MD in Beijing Jishuitan Hospital from 2017 to 2021 were collected by hospital information system and analyzed retrospectively. The medical data of patients extracted included gender, age, body weight, body mass index (BMI), fracture site, pain score and grading, time from fracture to admission, duration of T2MD, laboratory test results at admission, blood glucose control regimen and monitoring result after admission, and the adverse events. Patients were divided into CSII group and MDII group according to blood glucose control regimen during the perioperative period. The clinical features, time to reach target blood glucose range, insulin application, and adverse events in patients of the 2 groups were compared. Results A total of 207 patients were enrolled in this study, including 90 males and 117 females, aged (61±15) years with BMI of (25.5±3.5) kg/m2. No significant differences were found in gender, age, BMI, fracture site, pain score and grading, time from fracture to admission, duration of T2MD, and laboratory test resurts at admission in patients between the 2 groups (all P>0.05). Patients in the CSII group had shorter time to reach target range of fasting blood glucose, 2-h postprandial blood glucose, and the both than those in the MDII group [(48.7±30.2) h vs. (78.7±44.5) h, P=0.003; (66.8±31.5) h vs. (93.3±47.6) h, P=0.001; (68.4±30.5) h vs. (96.3±48.1) h, P<0.001]. The total daily dose and total pre-prandial dose of insulin per unit weight in patients when the fasting and 2-h postprandial glucose both reach the target range were less in the CSII group than those in the MDII group [(0.67±0.20) U/kg vs. (0.73±0.17) U/kg, P=0.030; (0.34±0.10) U/kg vs. (0.38±0.09) U/kg, P=0.004]. In 207 patients, hypoglycemia occurred in 17 patients for 23 times with an overall incidence of 8.2%(17/207). The difference in the incidence of hypoglycemia was not significant between the 2 groups [4.9%(5/102) vs. 11.4%(12/105), P=0.319]. None of the 5 patients with hypoglycemia in the CSII group had hypoglycemia for 2 times or more, while 4 of the 12 patients in the MDII group had 2 times of hypoglycemia and 1 had 3 times of hypoglycemia. Other adverse drug events included allergy, systemic edema, nodular hyperplasia of subcutaneous fat, and persistent bleeding at the injection site. Eight patients in the CSII group had other adverse events, including device failure in 5 patients, and using insulin pump during anesthesia, in magnetic field environment, and in humid environment in 3 patients respectively. Conclusions CSII regimen is helpful for fracture patients with T2DM to achieve target blood glucose range earlier, and provides more ways and opportunities to correct hypoglycemia in patients. However, the insulin pump needs more professional maintenance in practice, so it has limitations to some extent in clinical application.
  • Huang Guangming, Zhang Hongliang, Huang Zhenguang, Liu Taotao
    Adverse Drug Reactions Journal. 2021, 23(9): 474-479. https://doi.org/10.3760/cma.j.cn114015-20201125-01174
    Objective To explore the clinical characteristics of posterior reversible encephalopathy syndrome (PRES) induced by bevacizumab. Methods Relevant databases at home and abroad were searched as of August 2020 and the case reports of PRES induced by bevacizumab were collected. The basic information of the patients, application of bevacizumab (usage and dosage, single use or combined use, combination regimen, etc.), occurrence time of PRES, clinical manifestations, imaging characteristics, intervention measures and outcomes, etc. were recorded and descriptively analyzed. Results A total of 25 patients derived from 21 literature were enrolled in the study, including 6 males and 19 females, aged from 6 to 72 years with a median age of 52 years. The primary diseases were colorectal cancer in 13 patients, breast cancer in 4 patients, lung adenocarcinoma in 2 patients, and each cholangiocarcinoma, liver cancer, ovarian cancer, renal cell carcinoma, hepatoblastoma, and glioblastoma in 1 patient respectively. Seven patients had a history of hypertension. Twenty-one patients were treated with bevacizumab combined with chemotherapy, and the other 4 were treated with bevacizumab alone. PRES occurred from 16-hours to 196 days after first use of bevacizumab, mostly within 21 days after the last medication. The main clinical manifestations included blood pressure elevation (in 21 patients), generalized tonic-clonic seizures (in 17 patients), persistent headache and dizziness (in 12 patients), coma or disturbance of consciousness (in 11 patients), visual impairment or vision loss (in 9 patients), nausea and vomiting (in 6 patients), language impairment or aphasia (in 5 patients), etc. Twenty-four patients underwent head magnetic resonance imaging and the results showed that vasogenic brain edema occurred in occipital lobe, parietal lobe, frontal lobe, cerebellum, or temporal cortex; one patient underwent head computed tomography examination and the result showed mild atrophy of the posterior cerebellum. After the diagnosis of PRES, all the 25 patients stopped taking bevacizumab and received symptomatic treatments. Twenty-three patients had normal blood pressure and relieved symptoms 2-13 days later with imaging examinations showing disappeared brain lesions after 9 days to 10 weeks (2 of which finally died because their condition of PRES worsened later), and the other 2 patients died because their symptoms were not relieved after symptomatic treatments. Two patients resumed bevacizumab treatment after the clinical symptoms and brain lesions in imaging examination disappeared completely, and PRES did not recur. Conclusions The time from the application of bevacizumab to the occurrence of PRES is various, mostly within 21 days after the last application. The clinical and imaging manifestations of PRES induced by bevacizumab are similar to those of PRES caused by other factors. After stopping bevacizumab and receiving symptomatic treatments, most patients could have a good prognosis. It should be alert to the deterioration of the PRES which can lead to death.
  • Wang Yina, Zuo Li, Yan Yu
    Adverse Drug Reactions Journal. 2024, 26(7): 385-389. https://doi.org/10.3760/cma.j.cn114015-20240507-00308
    Due to the characteristics of cytotoxicity, vascular toxicity, and immunotoxicity, anticancer drugs may be more likely to cause kidney injury than other drugs. It is an important content in anti  tumor treatment to fully understand the clinical manifestations and risk factors of anticancer drug related renal injury, and evaluate the disease severity reasonably, so as to better adjust the anticancer schedule. Thus, the Japanese Society of Nephrology, Japan Society of Clinical Oncology, Japanese Society of Medical Oncology, and Japanese Society of Nephrology and Pharmacotherapy have jointly formulated the Clinical Practice Guidelines for Management of Kidney Injury During Anticancer Drug Therapy 2022 and made special discussions and suggestions on the definition, evaluation methods, main clinical manifestations, and risk factors of drug induced kidney injury in cancer patients after receiving anticancer drug treatments. This article interprets this part of the content in order to make more effective guidance in clinical practice.

  • 调查研究
    Tan Cie
    . 2001, 3(3): 151-154.
    Objective: To profile the drug- fever due to antimicrobial agents.Methods: In this study 12 hospitalized cases between June 1998 and September 1999 were enrolled who had drug - fever confirmed during antiinfective treatment. Results: More antimicrobials resulted in fever in 12 patients, even more than one drug responsible for the fever in 6 cases. The temperature was back to normal 2-3 days after withdrawal of the drug (9 cases) while it was down pretty soon with another suitable drug substituted (3 cases) .Conclusion: Drug- fever is mainly caused by β- lactam antibiotics like piperacillin sodium. It is important that doctors should bear the ADR of drug - fever in mind to avoid misdiagnosis.
  • 调查研究
    Wu Yuanshan;Zheng Qikun
    . 2000, 2(2): 88-91.
    86 drugs could cause hematuria on reference review of 1980-1998. Analgesic and anti-inflammatory agents were the culprit in both kinds (22) and cases (230), and Ganmaotong was the first among them. The causes of hematuria were discussed. Rational use of drugs was suggested in order to reduce the drug-induced renal damage.
  • Han Mei, Ge Ming, Liu Yuee
    Adverse Drug Reactions Journal. 2020, 22(4): 233-238. https://doi.org/10.3760/cma.j.cn114015-20190409-00348
    Objective To explore the clinical characteristics of hand-foot syndrome(HFS) induced by apatinib. Methods Case reports of HFS induced by apatinib were collected through sear- ching PubMed, VIP, CNKI, and Wanfang databases (up to March 20, 2019). The clinical characteristics of HFS induced by apatinib were analyzed according to the literature above and the information from 2 related patients admitted to Kailuan General Hospital. Results A total of 16 patients were enrolled in the study, including 9 males and 7 females, aged (62±16) years. Apatinib was applied for gastric cardia cancer in 4 patients, lung cancer in 4 patients, ovarian cancer in 2 patients, thyroid cancer in 2 patients, and other malignant tumors in 4 patients. And it was used alone in 11 patients and in combination with other antineoplastic agents in 5 patients. Dosages of apatinib included 850-mg/d in 3 patients, 500-mg/d in 6 patients, 425-mg/d in 1 patient, and 250-mg/d in 6 patients (the dose was increased to 500-mg/d in 2 patients after 1 and 2 weeks of administration, respectively). According to the severity, HFS was classified as grade 1 in 2 patients (12.5%), grade 2 in 6 patients (37.5%), and grade 3 in 8 patients (50.0%). Except that the time from application of apatinib to HFS occurrence was not known in 1 patient, the median time from medication to HFS occurrence was 3 (1-11) weeks in other 15 patients, and 10 (66.7%) of them developed HFS within 3 weeks of administration. In addition to the skin lesions of HFS, the skin/mucous membrane damage also appeared on perianal area, genital, axillary fossa, groin, and mouth in 5 patients. Among the 16 patients, 13-had other adverse events, including hypertension in 10 patients (62.5%). The symptoms of 8 patients with HFS of grade 1-2 mostly improved or were tolerable after symptomatic treatments. And in detail, 3 patients′ symptoms had no effect on the treatment of apatinib, 4 patients could tolerate a reduced dose or re-medication after a pause, and 1 patient stopped medication. Symptomatic treatment effects were poor in 8 patients with grade 3 HFS, 4 of whom stopped apatinib because of the serious HFS and 3 of whom died. Conclusions The HFS induced by apatinib usually occurs within 3 weeks after administration, which can involve many parts of the body except for the skin of hands and feet, and are accompanied with hypertension mostly. HFS symptoms can be relieved by symptomatic treatments, reasonable dose reduction, or drug withdrawal in most patients.
  • Wang Chuan, Liu Min, Li Zhongdong
    . 2016, 18(1): 19.
    ObjectiveTo evaluate the incidence of equal to or greater than grade 3 adverse reactions of cetuximab combined with chemotherapeutic drugs or only chemotherapeutic drugs in treatment of patients with advanced colorectal cancer (ACRC)or metastatic colorectal cancer (mCRC).MethodsThe databases of MEDLINE, PubMed, Embase, Cochrane Library, China National Knowledge Infrastruc-ture, Wanfang Database and Vip Database from the  inception to September 2014 were searched. The randomized controlled trial (RCT) which were about cetuximab combined with chemotherapy drugs (experimental group) or only chemotherapy drugs (control group) in treatment of patients with ACRC or mCRC were collected. The software of Review Manager 5.3 was used for meta-analysis. The incidence of equal to or greater than grade 3 adverse reactions of cetuximab combined with chemotherapy drugs or only chemotherapy drugs between the two groups were compared. The results were shown by odds ratio (OR) and 95% confidence intervals (CI).ResultsA total of 14 papers were enrolled into this Meta-analysis. There were 9 RCTs without the blinding design, 3 RCTs without the number of lost and 2 RCTs without the patients' basic information out of the 14 papers. The result of the test of heterogeneity showed no significant heterogeneity among the RCTs. A total of 9 876 patients were enrolled into the Meta-analysis, including 4 927 patients in the experimental group and 4 949 in the control group. The incidence of 9 kinds of ≥3 grade of adverse reactions among the 11 adverse reactions which reported in the 14 papers in the experimental group were higher than those of the control group, such as acneform rash [14.2% (695/4 886) vs. 0.2% (12/4 926), OR=57.03, 95% CI: 33.85-96.10, P<0.001], oral mucositis [5.4% (134/2 466) vs. 1.9% (48/2507), OR=2.97, 95% CI: 2.13-4.16, P<0.001], hand-foot syndrome [7.9% (114/1 439) vs. 3.1% (45/1 436), OR=2.68, 95%CI: 1.88-3.83, P<0.001], anaphylactic reaction [5.2% (102/1 973) vs. 1.9% (39/2 014), OR=2.66, 95%CI: 1.84-3.86, P<0.001], anorexia [4.3% (124/2 878) vs. 2.4% (70/2 914), OR=1.82, 95%CI: 1.35-2.45, P<0.001], diarrhea [17.9% (876/4886) vs. 12.6%(539/4926), OR=1.80, 95% CI: 1.60-2.02, P<0.001], fatigue [6.4% (242/3 793) vs. 4.2% (162/3 818), OR=1.53, 95% CI: 1.24-1.87, P<0.001], nausea and vomiting [8.4% (380/4 548) vs. 7.1% (325/4 590), OR=1.22, 95%CI: 1.04-1.42, P<0.001], and leucopenia [17.8% (869/4 886) vs. 16.1% (794/4 926), OR=1.14, 95%CI: 1.02-1.27, P=0.02]. There was no significant difference in the incidence of anemia between the experiment group and the control group [2.6% (33/1 258) vs. 2.4% (29/1 231), OR=1.11, 95% CI: 0.68-1.83, P=0.67]. The incidence of peripheral neuropathy in the experiment group was lower than that in the control group[10.5% (170/1 620) vs. 14.7% (237/1 608), OR=0.67, 95%CI: 0.54-0.83, P<0.001]. The sensibility analysis showed the above-mentioned results were steady and dependable.  ConclusionComparison with only using chemotherapeutic drugs in treatment of patients with ACRC or mCRC, cetuximab combined with chemotherapy drugs may increase the incidence of ≥ 3 grade adverse reactions except severe anemia and severe peripheral neuropathy.
  • Chen Zhidong
    . 2015, 17(1): 40-4.
    ObjectiveTo understand occurrence and causes of severe medication errors (SME) in hospital and provide a basis for formulating preventive measures.MethodsAdverse drug reactions or adverse events cases which were reported by the Sixth People′s Hospital Affiliated to Shanghai Jiao Tong University from 2010 to 2013 were collected. And the ME cases of category E to I (Categories E through I were respectively errors occurred that may have contributed to or resulted in temporary harm to the patient [E], hospitalization or prolonged hospitalization [F], permanent patient harm [G], required intervention necessary to sustain life [H], and the patient′s death [I]. SME contained ME of category E to I.) were selected and analyzed retrospectively. Main analysis indexes included category, clinical manifestation, triggering factor, and involved drug and department. ResultsA total of 511 adverse drug reactions or adverse events cases were collected. Of them, 80 SME cases (15.66%) were selected. Proportion of SME cases in 2010 to 2013 were respectively 22.52%(59/262), 16.67%(10/60), 3.95%(3/76), and 7.08%(8/113) to all the adverse drug reactions or adverse events cases in that year. Of the 80 SME cases, the proportion in 2010, 2011, 2012, and 2013 were respectively 73.75% (59 cases) , 12.50% (10 cases), 3.75% (3 cases), and 10.00% (8 cases) and the proportion of category E, H, and I were respectively 95.00% (76 cases), 3.75% (3 cases), and 1.25% (1 case). The most manifestation of ME of category E was skin rash and all the symptoms of ME of category H were anaphylactic shock. ME of category I caused the patient′s death. In 80 SME cases, there were 81 records including 78 records (96.30%) of excessive doses for one time and 1 record each of excessive doses for a day, insufficient solvent, and contraindication. The 80 SME cases were related to 18 kinds of drugs and, of them, 76 records (93.83%) were related to 14 kinds of antibacterial agents. The 80 SME cases were associated with 14 departments and the top three were respectively the department of emergency(46.25%, 37/80), osteology(15.00%, 12/80), and general surgery(11.25%, 9/80).ConclusionsThe ME of category E was primary SME in our hospital and the main triggering factor was excessive doses for one time. However, there was 1 ME case of category I which resulted in the patient′s death. So some effective preventive measures should be carried out to strengthen prevention.
  • Yang Wanna, Hou Fengqin
    . 2015, 17(4): 291.

    Oxaliplatin is the third generation of platinum drugs, used in chemotherapy of colorectal carcinoma. Oxaliplatin can injure hepatic sinusoidal endothelial cells to induce hepatic sinusoidal obstruction syndrome (HSOS). The incidence of oxaliplatin induced HSOS was 77.4%. The clinical manifestations were hepatalgia, weight gain, ascites, hepatomegaly and jaundice. Histopathologic features include hepatic sinusoidal dilation and congestion, centrilobular vein obstruction, perisinusoidal fibrosis and centrilobular hepatic cell necrosis. The lack of typical imaging manifestations, biomarkers and effective treatment, so prevention-oriented strategy is important. Bevacizumab, regorafenib, sorafenib, recombinant human soluble thrombomodulin, and antioxidant may prevent HSOS. Defibrotide is recommended for treatment of HSOS.

  • 论著
    Bai Yan;Li Yue;Liu Bin;Wang Kun;Mei Hekun;Zhang Ying;Wang Jin;Wang Rui
    . 2014, 16(3): 134-5.
    To investigate the research progress of hepatotoxicity due to antifungal drugs, in order to provide a reference for clinical safety use of antifungal drugs.Methods"Antifungal drugs" and "hepatotoxicity" were selected as the keywords, and PubMed, Embase, Web of Science, Chinese Academic Periodical Full-text Database China HowNet Chinese Academic Journal (CNKI) and Chinese Biomedical Literature database (CBMdisc) were searched. All literature on hepatotoxicity due to antifungal drugs were selected. A database of literature accepted for final bibliometric study was established by using Microsoft Excel. The parameters of bibliometrics such as published time (years), the top 5 countries and institutes in publishing, literature′s type, published time (years), top 5 journals in publishing number, top 10 articles in terms of cited frequency were studied. The main content and hotspot of literature were analyzed. The clinical manifestations, mechanism, incidence and prophylactico-therapeutic measures of hepatotoxicity due to antifungal drugs were summarized.ResultsA total of 221 articals (193 in English, 28 in Chinese) were enrolled in the study, of which 116 were original articles, 49 reviews and 56 case reports. The published time of first original publication of hepatotoxicity due to antifungal drugs were 1976. The journal which published largest number of articles was Mycoses. The highest citation number of individual article was 531. The main clinical manifestations were weak, right upper quadrant pain, diarrhea, jaundice, cholestasis and fever. The severe cases could cause liver failure. Laboratory examination showed elevated serum transaminases, bilirubin, and alkaline phosphatase. The incidence of liver toxicity due to azole antifungals was higher, the incidence of liver toxicity due to amphotericin B was lower. The antifungal drugs should be used with caution in patients with hypohepatia. For the patients who used antifungal drugs for long time, the liver function should be monitored regularly. If liver injury occurs, the antifungal drugs should be stopped immediately. Some patients′ liver function test results could return to the normal levels before administration of the symptomatic treatment and the supportive liver protection therapy. The mechanism of hepatotoxicity due to antifungal drugs was unknown, it may be related to the damage of cytoplasmic membrane structure and inhibition of metabolism in cytochrome P450 2D6 enzyme. ConclusionsThe research abroad on hepatotoxicity due to antifungal drugs are ahead of China. Hepatotoxicity due to antifungal drugs is partially reversible.
  • Jiang Yongxian, Li Gen, Wang Yulan, Wu Bo, Wang Han, Zhu Ling
    Adverse Drug Reactions Journal. 2020, 22(1): 25-31. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.01.006
    Objective To explore the occurrence and clinical characteristics of hypersensitivity reactions induced by antimicrobial drugs in neonates. Methods The reports of hypersensitivity reactions induced by antimicrobial drugs in Neonatology Department of Chengdu Women′s and Children′s Central Hospital from January 1, 2015 to December 31, 2017 were collected. According to the basic information of children provided by the reports, the electronic medical records of the children were collected from the hospital information system and the data of application, occurrence, treatments, and outcomes of hypersensitivity reactions were recorded. The clinical manifestations, types, and severity of hypersensitivity reactions were evaluated by 3 pharmacists according to relevant standards. From the hospital information system, the total number of outpatients and inpatients in Department of Neonatology in the same period was counted, the usage of antimicrobial drugs was recorded, and the incidence of hypersensitivity reactions due to antimicrobial agents was caculated. Results A total of 73 reports of hypersensitivity reactions to antimicrobial drugs in Department of Neonatology were entered, involving 73 newborn infants; there were 21-146 infants using antimicrobial agents at the same time, so the incidence of antimicrobial hypersensitivity reactions was 0.35%. Among the 73 children, 34 were male and 39 were female; the ages on visit or admission to the hospital was (14±7) days; 69 (94.52%) were given injections of antimicrobial agents and 4 (5.48%) were given oral preparations. A total of 20 antimicrobial agents of 7 categories were used; the top 3 were cephalosporins (32 infants, 43.84%), penicillins (21 infants, 28.77%), and cephamycins (6 infants s, 8.22%). The top 3 drugs with higher incidence of hypersensitivity reactions were levofloxacin hydrochloride injection (2/4), erythromycin lactobionate for injection [1.29% (4/311)], and vancomycin hydrochloride for injection [1.07% (4/374)]. Among the 73 infants, 4 (5.48%) had immediate hypersensitivity reactions, of which 3 were severe (including 1 with anaphylactic shock, 1 with dyspnea, and 1 with severe anaphylactic reaction) cases; 69 (94.52%) had nonimmediate hypersensitivity reactions, mainly manifested as rash, digestive system symptoms, and fever, of which 6 were severe cases (including 3 infants with hepatobiliary system injury, 2 with neutropenia, and 1 with severe drug eruption). After discontinuation of suspected drugs and/or antiallergic and symptomatic treatments, 71 of 73 newborns recovered (97.26%) and 2 (2.74%) improved. Conclusions The incidence of hypersensitivity reactions induced by antimicrobial drugs in newborns in Chengdu Women′s and Children′s Central Hospital was 0.35%. The clinical types of hypersensitivity reactions induced by antimicrobial drugs in neonates were mainly nonimmediate types, most of them were general hypersensitivity reactions, but the immediate drug hypersensitivity reactions were mostly severe hypersensitivity reactions.
  • Li Xiaoling, Yan Suying, Wang Yuqin, Zhao Chengcheng, Lu Lu
    . 2015, 17(4): 247.
    ObjectiveTo investigate the method of essential medicines selection in China. The angiotensin II receptor antagonist (ARB) drugs were taken as templet.MethodsARB drugs recommended by "Guidelines for the prevention and control of hypertension in China 2010" including losartan, valsartan, irbesartan, telmisartan, candesartan and olmesartan were included as the intended evaluating drugs. Each drug′s information (I), safety (S), administration restriction and frequency of drug administration (af), and efficacy (E) scores were evaluated respectively and were put together as ISafE. The weight and evaluation of every index were confirmed by the suggestions of specialists in clinical medicine, pharmacy, and epidemiology in China. The weight of safety and efficacy were 40%, respectively, and the information and administration restriction and frequency of drug administration were 10%, respectively. The score of each drug′s ISafE was calculated. The ratio of each drug′s daily medication costs to score of ISafE was the essential medicine cost index (EMCI).The EMCI of each drug was ranked according to the value. The  lower the drug′s EMCI value, the drug would be more likely to be recommended.Results The scores of information in the 6 ARB drugs from high to low in turn were losartan,valsartan, telmisartan, irbesartan, candesartan, and olmesartan. The scores of efficacy in the 6 ARB drugs from high to low in turn were olmesartan, telmisartan, valsartan, irbesartan, candesartan, and losartan. The scores of safety in the 6 ARB drugs from high to low in turn were telmisartan, olmesartan, irbesartan, candesartan, valsartan, and losartan. The 6 ARB drugs had the same scores in af value. The scores of ISafE in the 6 ARB drugs from high to low in turn were telmisartan, olmesartan, irbesartan, valsartan, losartan, and candesartan. The EMCI value of valsartan was the lowest among the domestic ARB drugs. The above-mentioned result was consistent with that of valsartan, which was the only ARB drug enrolled into the Chinese essential medicine list. The EMCI value of telmisartan was the lowest among the joint-stock ARB drugs.ConclusionISafE method, which has been optimized and localized, has the characteristics of objective information and high maneuverability and could provide reference for improvement of the selection of essential drugs in China.
  • 论著
    Ma Xiuyun;Cai Haodong;Xu Yanli;Bu Zhijun;Cao Chuanmei
    . 2007, 9(2): 81-84.
    Objective: To evaluate the dose-response relationship and safety of entecavir for treating chronic hepatitis B virus infection. Methods: In a randomized, double-blind, placebo-controlled study, the patients with hepatitis B virus infection and without previous antiviral therapy were assigned to following 3 groups in the ratio of one to one to one: entecavir 0.5 mg/d group, entecavir 0.1 mg/d group, and placebo group. The patients were treated for 28 d. The postdosing follow-up was 56 d. And then the patients in the three groups were treated with entecavir 0.5 mg/d during the 48 weeks open-label treatment phase of the study. The postdosing follow-up was 24 weeks. Results: The entecavir 0.5 mg/d had more potent antiviral activity than that of entecavir 0.1 mg/d, and the HBV DNA breakthrough was slower after discontinuation of the drug. In the end of open-label treatment phase, the HBV DNA levels were decreased to < 0.7 mmol/ml in 81.6% patients, and the rate of HBeAg/anti-Hbe seroconversion was 7.9%. But the HBV DNA levels were increased again in 80% patients after the drug withdrawal. There were no statistically differences (P=0.428) in the incidence of adverse events between the entecavir therapy group and placebo group, the serious adverse reactions related to the entecavir were not found during the open-label treatment phase. Conclusion: Entecavir has potent antiviral activity against HBV, and its antiviral effect is related to the dosage. The entecavir 0.5 mg/d is more effective and safer in treating patients with chronic hepatitis B virus infection.
  • 病例报告
    . 2005, 7(1): 60-60.
  • 安全用药
    . 2004, 6(1): 20-22.
    本文介绍了肝素相关性血小板减少症的发病机理、临床表现、诊断和治疗方面的研究,以有助于提高临床对该综合征的早期识别、早期诊断和治疗。
  • 安全用药
    . 2004, 6(1): 22-27.
    本文重点介绍了常用抗高血压药物的不良反应及有关临床处理对策。旨在加深对抗高血压药物不良反应的认识,提高临床安全用药水平,减少不良反应的发生。
  • 中毒救治
    . 2005, 7(2): 114-115.
    乌头类中药主要毒性成分是乌头碱等生物碱,人口服乌头碱3~5m g可使人致死。乌头碱主要损害循环系统及中枢神经系统,其对循环系统的损害主要是导致各种心律失常。目前治疗上尚无特效解毒剂,早期、足量、反复给予阿托品及其他抗心律失常药物的使用是主要的治疗措施,血液灌流对于重度中毒患者有较好的疗效。
  • Cai Haodong
    Adverse Drug Reactions Journal. 2021, 23(7): 357-360. https://doi.org/10.3760/cma.j.cn114015-20210702-00739
    Patients with chronic kidney disease (CKD) are at high risk for coronavirus disease 2019 (COVID-19). Government agencies or learned societies in many countries recommend prioritizing patients with CKD for COVID-19 vaccines. The immune response rate to the COVID-19 vaccines is lower in hemodialysis patients and kidney transplant recipients compared with that in healthy individuals, and increasing the number of vaccinations each member of these population may improve their immune response rate. There was no significant difference in the incidence of adverse reactions after vaccination between patients with CKD and healthy controls. Patients with stable CKD should be vaccinated against COVID-19 unless there were contraindications to vaccination. The mRNA vaccines, inactivated vaccines, and recombinant protein subunit vaccines are all safe for patients with CKD. Patients with CKD treated with rituximab or high-dose glucocorticoid need to weigh the benefits and risks before vaccination, and COVID-19 vaccines can be given when rituximab treatment ends for more than 6 months or after glucocorticoid reduction.
  • 中毒救治
    . 2004, 6(1): 36-39.
    对乙酰氨基酚是解热镇痛抗炎药中最常用的药物。本文对其发生中毒的机制、早期及晚期中毒的救治以及预防等方面的研究进行介绍。
  • 调查研究
    He Suiping Liang Jianhua
    . 1999, 1(3): 159-162.
    Objective: To analyze ADR distribution and the cost of treatment for ADR. Method:Original data of 126 ADR cases and of durgs used for the treatment of ADR were statistically analyzed; and the amount of money spent on drugs for treating ADR was calculated. Result:In 126 cases, ADRs caused by antibacterial drugs ranked first. The major clinical manifestations of ADR in decrease order of frequency were skin reactions, digestive system reactions, nervous system reactions and cardiovascular system reactions. Medium and severe reactions accounted for 71.4% ; the mean duration was 11.13 days; and 13 kinds of drugs were used most frequently. The expense in drugs only was 117675. 34 yuan, and the highest one used for a patient was 32315. 89 yuan. Conclusion: It would be helpful to decrease the occurance of ADR and improve the pharmaceutical care through the drug safety monitoring and the analysis of ADR-related cost.
  • 病例报告
    Sun Xiangju;Wu Yubo;Jiang Aihua
    . 2010, 12(6): 409-2.
    A 57yearold male patient was hospitalized with cerebral infarction and received ozagrel, aspirin and fusudil. On day 7, he took zolpidem 10 mg due to insomnia and anxiety at bed time. The patient presented with urinary incontinence at night. The next day, he had no memory of the event. After a day’s interval, his zolpidem dose was decreased to 5 mg. The patient’s abovementioned symptoms recurred after repeated administration of zolpidem. A review of his history revealed that, a few months earlier, he had received zolpidem and had developed the same reaction.
  • 论著
    WANG Ying-zheng;LU Min;ZHOU Ying;CUI Yi-min
    . 2012, 14(5): 277-5.
    ObjectiveTo evaluate the efficacy and safety of combination therapy with saxagliptin and metformin in patients with type 2 diabetes. Methods “saxagliptin” and “metformin” were selected as keywords and PubMed and EMbase were searched. All randomized controlled trials (RCTs) of saxagliptin therapy in patients with type 2 diabetes were selected. According to the inclusion criteria, the articles were selected, evaluated, and meta-analyzed with RevMan 5.1 software. The levels of glycosylated haemoglobin (HbA1c) and fasting plasma glucose (FPG), the incidence of hypoglycemia after the treatment with saxagliptin + metformin (the saxagliptin group), placebo + metformin (the placebo control group) and other hypoglycemic drugs + metformin (the positive drug control group) were compared in patients with type 2 diabetes and their results were presented in mean difference (MD) or relative risk (RR) with 95% confidence interval (CI). ResultsA total of 5 RCTs were entered. The results of meta-analysis were as follows: the treatment effect of decrease in HbA1c levels in the saxagliptin group was better than that in the placebo control group ( MD=-0.59, 95%CI:-0.87 to -0.32, P=0.00) and the positive drug control group (MD=-0.36, 95%CI:-0.73 to -054, P=0.00); the treatment effect of decrease in FPG levels in the saxagliptin group was better than that in the placebo control group (MD=-1627,95%CI:-21.64 to -10.91, P=0.00); however, the difference in treatment effect of decrease in FPG levels between the saxagliptin group and the positive drug control group was not statistically significant (MD=-2.75, 95%CI:-22.52 to 17.01, P =0.78); there was no significant difference in the incidence of hypoglycemia between the saxagliptin group and the placebo control group or the positive drug control group (RR=0.55,95%CI:0.15 to 2.09, P=0.38). ConclusionThe combination therapy with saxagliptin and metformin is effective to decrease the HbA1c and FPG levels in patients with type 2 diabetes. It also has a good safety profile.
  • 病例报告
    Wang Ling;Yu Yongyang;Zhang Baohui
    . 2007, 9(5): 375-375.
    A 50-year-old woman with chronic asthmatic bronchitis received IV furosemide 20 mg for treating oedema of the lower extremity.Then she developed severe dyspnoea and cyanosis of the face and lips.After inhalation of oxygen,anti-anaphylaxis and symptomatic treatment,her symptoms relieved.Tracing her previous history,the patient had developed the similar symptom following intravenous injection of diuretics for oedema many years before.
  • Yang Jia, Jiang Yongxian, Chen Wenwen, Tao Wanjun, Li Gen
    Adverse Drug Reactions Journal. 2021, 23(4): 202-204. https://doi.org/10.3760/cma.j.cn114015-20200702-00733
    An one-month-old boy was treated with diazoxide capsules purchased by his parents from abroad for congenital hyperinsulinemia. In order to correct his hypoglycemia, the treatment plan was designed as follows: diazoxide capsules with an initial dose of 8.72-mg orally thrice daily [5-mg/(kg·d)] and intravenously high concentration glucose were given at the same time, then the supplement of intravenous glucose was gradually reduced and the dose of diazoxide was gradually increased under close monitoring of blood glucose levels, and finally the intravenous glucose was stopped with the stable blood glucose level (≥3.9-mmol/L). During the first 7 days of treatment, the dose of intravenous glucose and diazoxide were adjusted as planned, the child′s blood glucose was 3.1-5.3-mmol/L, and no hypoglycemia occurred. On the 8th day, the pharmacist found that the child was not awake and the blood glucose was 2.2-mmol/L during patient rounds. After questioning his parents, it was found that the dose of diazoxide was reduced to the initial dose by the parents themselves, leading to an episode of hypoglycemia, which was a medication error caused by the lack of self-supplied drugs management. The pharmacist immediately intervened on his parents′ treatment adherence. The dose of diazoxide was re-adjusted and the child′s blood glucose returned to normal. With the increase of the diazoxide dose, the child developed an adverse reaction of water and sodium retention. The addition of hydrochlorothiazide was recommended by the pharmacists after reviewing previous literatures and the adverse reaction of the child disappeared. Through this case, the clinical management standard of self-supplied drugs for special diseases and the database of safe drug use were established and a multi-disciplinary team for joint services consisting physicians and pharmacists was formed in the hospital under the efforts of clinical pharmacists. The safety management of medication in treatment of hospitalized and discharged children was strengthened and good results have been achieved.
  • 专题讲座
    . 2003, 5(3): 178-183.
  • Qiu Lulu, Lyu Huiyi
    . 2015, 17(6): 455-455.
    A 73-year old woman with hypertension received amlodipine (5 mg once daily) and bisoprolol (2.5 mg once daily). One year later, she developed the symptoms of gingival swelling, bleeding, and difficult to chew and occlude. She was diagnosed as gingival hyperplasia by a doctor of department of stomatology and underwent resection of gingiva that had hyperplasia. The patient could chew 5 days after the operation. The patient′s gingival hyperplasia was considered as amlodipine-induced gingival overgrowth. Amlodipine was withdrawn and use of hydrochlorothiazide was started, but bisoprolol was continued. The result of return visit 6 months after operation showed the symptoms of gingiva, swelling and bleeding did not occur again, and the blood pressure was controlled stablely.
  • Ren Hao, Zhao Jinjun, Lin Jingli, Cui Danyu, Lai Weinan, Huang Qin, Yang Min
    . 2015, 17(3): 232.
    Four female patients (aged 17, 14, 25, and 20, respectively) with systemic lupus erythematosus (cases 1 and 2 were complicated with type IV lupus nephritis) received high-dose methylprednisolone pulse therapy, which included an IV infusion of methylprednisolone 0.5 g daily for 3 days, and then instead of prednisone 1-2 mg·kg-1·d-1 orally. Five to eighteen days after administration, the four patients developed the symptoms of mental disorders, such as exciting, garrulous, anxiety, mania, hardly fall asleep, even delusion of persecution and suicidal tendency. The four patients returned to normal completely after 19 days to 2.5 months by decreasing the dosage of the steroid gradually and the treatment with sedatives and antipsychotic drugs.
  • 中毒救治
    . 2007, 9(1): 46-47.
  • 病例报告
    FENG Zao-ming;TANG Min;HUANG Mao-tao
    . 2013, 15(1): 49-2.
    A 62-year-old male patient was hospitalized with bullous pemphigoid. He received prednisone 15 mg thrice daily, loratadine 10 mg once daily, and cefradine 0.5 g thrice daily by mouth as well as symptomatic and supportive therapy. Three days later, occasional agitation appeared in the patient. However, he did not receive any treatment. Seven days later, the dose of prednisone was increased to 60 mg/d for poor control of rash. Eight days later, he experienced anxiety, dysphoria, agitation, persecutory delusion, abnormal behavior, memory loss, and occasional failure to recognise location. The dose of prednisone was then decreased to 45 mg/d. Loratadine was discontinued. He was switched to oral cyproheptadine 2 mg thrice daily, and other therapy was the same as before. One week later, the patient′s psychiatric symptoms gradually relieved and he was discharged. The dose of prednisone was gradually reduced and then stopped 45 days after discharge. The patient had no recurrence of similar psychiatric symptoms at a 3-month follow-up.
  • 论著
    Xu Juan① Song Wei①;Jin Hui②;Sun Xuejing①;Su Li①;Li Ta②;Ji Bingxin①;Zhang Chenwei①
    . 2007, 9(5): 311-315.
    Objective:To observe the effects of recombinant human granulocyte colony-stimulating factor(rhG-CSF)on peripheral active signal of T cell surface antigen(CD4+CD28+,CD8+CD28+),activated T cells,and regulatory T cells during mobilization of hematopoietic stem cells and its safety of application in health donors.Methods:Thirty normal hematopoietic stem cells donors(19 males,11 females,median age 28 years,range 14~56 years)received rhG-CSF 5 μg/kg daily subcutaneously for 4~6 days.Relative fluorescence intensity(RFI)of CD28 antigen expression on peripheral CD4+ cells and CD8+ cells,the percentage of CD4+CD25low and CD4+CD25high in CD4+ T cells were measured with a flow cytometry before rhG-CSF administration and on day 1,day 3,and day 7 after rhG-CSF discontinuation,respectively.The peripheral WBC and PLT counts,liver and renal functions,and ultrasonic measurement of spleen were performed on the day1,day 7,and day 30 after rhG-CSF discontinuation.Results:Relative fluorescence intensity of CD28 antigen expression on peripheral CD4+ cells and CD8+ cells was 14.91±6.10 and 11.10±3.74 before rhG-CSF administration,respectively,and decreased to 11.93±5.39 and 8.53±3.74 on day 3 after rhG-CSF discontinuation,respectively.The differences were statistically significant(P=0.034,P=0.033).The percentage of CD4+CD25low T cells in CD4+ cells was(21.4±8.87)% before rhG-CSF administration,and decreased to(18.23±5.89)% on day 3 after rhG-CSF discontinuation.The difference was no statistically significant(P>0.05).The percentage of CD4+CD25high T cells in CD4+ T cells was(4.16±1.62)% before rhG-CSF administration and increased to(6.43±2.46)% on day 1 after rhG-CSF discontinuation.The difference was statistically significant(P=0.000).The WBC count and ultrasonic measurement of spleen were(5.91±1.02)×109/L and(33.76±2.76)cm2 before rhG-CSF administration,respectively,and increased to(34.13±8.07)×109/L and(46.85±4.53)cm2 on day 1 after rhG-CSF discontinuation ;the PLT conut were(228.07±73.69)×109/L before rhG-CSF administration,and decreased to(158.27±40.69)×109/L on day 7 after rhG-CSF discontinuation.The differences were statistically significant(all P=0.000).ALT and Cr were(28.23±7.69)IU/L and(60.70±15.86)μmol/L before rhG-CSF administration,respectively,and were(27.17±7.23)IU/Land(61.10±16.38)μmol/L on day 1 after rhG-CSF discontinuation,respectively.The differences were no statistically significant(all P>0.05).Conclusion:rhG-CSF can decrease relative fluorescence intensity of CD28 antigen expression,decrease and increase the percentage of activated T cell and regulatory T cells in CD4+ T cells,respectively.The changes return to baseline levels prior to mobilization on day 7 after rhG-CSF discontinuation.There is no untoward effects to liver and renal functions in health donors
  • Qiu Yanlong, Guan Haifang
    Adverse Drug Reactions Journal. 2021, 23(1): 49-50. https://doi.org/10.3760/cma.j.cn114015-20200203-00078
    A 2-year-old boy with hydrocele of spermatic cord received an IV infusion of ketorolac tromethamine injection 7-mg after laparoscopic high ligation of bilateral sheath to relieve pain. About 17-hours after the medication, the boy developed gross hematuria. Ultrasonic examination showed blood clots in the bladder. Routine urine analysis showed urine occult blood (++), red blood cells >50 cells per high-power field in urine microscopy, and protein (+++). The boy did not use other drugs in the same period, and hematuria related to ketorolac tromethamine injection was considered. The boy received IV infusions of etamsylate injection 0.5 g once daily and then ceftriaxone sodium for injection 0.5 g once daily successively. After 6 days of treatments, the boy′s gross hematuria disappeared. Routine urine analysis showed urine occult blood (+++), 3 red blood cells per high-power field in urine microscopy, and urine protein (+++). Eleven days later, the re-analysis showed urine occult blood (+), none red blood cell per high-power field in urine microscopy, and urine protein (++). One month later, the re-analysis showed urine occult blood (-) and urine protein (-).
  • Wu Jingfang, Xin Meiyun, Han Lei
    Adverse Drug Reactions Journal. 2020, 22(8): 490-491. https://doi.org/10.3760/cma.j.cn114015-20190311-00243
    A 7-year-old boy coughed for 7 days. His parents fed him fresh and ripe cocklebur fruit (Fructus Xanthii) once which was picked and fried by themselves (unknown dose). On the 3rd day after feeding the cocklebur fruit, the boy developed paroxysmal epigastric pain, with vomiting, anorexia, fatigue, drowsiness, and low fever. The laboratory tests showed alanine aminotransferase (ALT) 3-344-U/L, aspartate aminotransferase (AST) 3-501-U/L, serum total bilirubin (TBil) 26.5 μmol/L, direct bilirubin (DBil) 19.0 μmol/L, albumin (ALB) 32.8-g/L, and blood ammonia 120-μmol/L. On the 6th day after feeding the cocklebur fruit, the boy developed aggravated fatigue, irritability, slightly slow response, and light yellowish staining of sclera. The laboratory tests showed ALT 4-565-U/L, AST 4-335-U/L, TBil 32.9-μmol/L, DBil 23.4-μmol/L, ALB 30.2-g/L, and blood ammonia 124-μmol/L. Acute liver failure due to cocklebur fruit poisoning was considered. The boy received blood purification therapy (2 plasmapheresis and 4 days′ hemodiafiltration) and symptomatic treatments. The laboratory tests showed ALT 1-043-U/L, AST 203-U/L, TBil 22.0-μmol/L, DBil 12.3-μmol/L, ALB 39.1-g/L, and blood ammonia 36.3-μmol/L. The blood purification therapy was stopped and the symptomatic treatments was continued. The laboratory tests 2 weeks later showed ALT 24-U/L, AST 35-U/L, TBil 13.8-μmol/L, DBil 4.6-μmol/L, and ALB 47.3-g/L.
  • 安全信息
    . 2009, 11(6): 450-1.
  • 中毒救治
    . 2003, 5(6): 393-394.
    文法拉辛为一新的抗抑郁药,是一种与其他抗抑郁药结构不同的双环化合物,本文对其急性中毒的临床表现、诊断与治疗加以探讨,以引起临床注意。
  • 论著
    ZHANG Yan-li;YI Nuo;CAO Yan-jun;FANG Fang;CAI Hao-dong
    . 2012, 14(6): 341-4.
    To explore the safety of fetus exposed to telbivudine in mother’s uterus. Methods The subjects were neonates whose mother underwent prenatal examination and delivered in Department of Obstetrics and Gynecology, Beijing Ditan Hospital, Capital Medical University from January 1 to November 15, 2012. All neonates were divided into 2 groups: the telbivudine group (the neonates borne by HBV-infected mothers receiving telbivudine 600 mg once daily during pregnancy) and the control group (the neonates borne by HBV-infected mothers receiving no either telbivudine or the same kind of drugs during pregnancy). All neonates’gender, birth weight and their mothers’age, parity, gestational weeks, and delivery pattern in the 2 groups were compared. The venous blood of neonates in the 2 groups were collected at birth and the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), α-hydroxybutyrate dehydrogenase (α-HBDH), creatine kinase (CK), and its isoenzyme (CK-MB) in the 2 groups were detected. ResultsThirty-one neonates entered into the telbivudine group and 35 neonates entered into the control group. There were no statistically significant differences in the neonates’gender, birth weight and their mothers’age, parity, gestational weeks, and delivery pattern in the 2 groups. There were no statistically significant differences in the levels of ALT, AST, LDH, α-HBDH, CK, CK-MB, and CK-MB/CK in the neonates in the 2 groups. ConclusionThere are no marked influence on levels of liver enzyme and myocardial enzyme in neonates borne by HBV-infected mothers receiving telbivudine during pregnancy, and the adverse influence of telbivudine on neonate safety has not been found.
  • 安全用药
    Yang Xinghua;Cui Xin
    . 2010, 12(5): 329-4.
    The commonly used contraceptives currently are combined oral contraceptives (COC) which consist of estrogen and progestogen and are only available for women. Use of COC may cause several serious adverse reactions and one of them is venous thromboembolism(VTE). VTE usually occurs within 1-2 years of starting COC use, but it is unaffected by duration of use, and disappeared after drug withdrawal. The risk of developing VTE among oral contraceptive users is 4 times that of nonusers. The occurrence of VTE is related to the dose of estrogen and the type of progestogen in combined oral contraceptives. The incidence of VTE is obviously reduced if the dose of estrogen is<50 μg; and the risk of developing VTE is higher in third-generation oral contraceptives than in second-generation oral contraceptives. The mechanism of VTE might be that estrogen in COC promotes the activation of fibrinogen, increases level of the coagulation factors, decreases the level of antiprothrombin, and enhances the coagulation function. The risk factors for COC-induced VTE are cardiovascular diseases, advanced age, smoking, VTE or family history of VTE, and longterm bed rest. It is suggested that the women of reproductive age should be screened for the risk factors before receiving COC in order to decrease the risk of developing VTE.
  • 不良事件
    . 2006, 8(3): 224-224.
  • 病例报告
    Bao Zhongyinga;Liu Meishenga;Yang Hongb
    . 2008, 10(3): 215-2.

    A 26yearold man was administered IV levofloxacin 0.3 g twice daily for treatment of pneumonia. Three days later, the man experienced insomnia and temporal paraphasia. On day 5, he presented with extreme excitement, abnormal behavior, and inability to fall asleep. The patient was treated with diazepam. The next day, levofloxacin was withdrawn and his symptoms improved gradually. He regained normal status 24 hours after discontinuation of levofloxacin.

  • 国外文献题录
    . 2001, 3(4): 269-270.
  • 病例报告
    . 2005, 7(2): 137-138.
  • 药源性疾病
    Jiang Yuyong
    . 2008, 10(3): 199-6.
    Autoimmune hepatitis (AIH) is a chronic inflammatory liver disease in which the body's own immune system destroys liver cells. It is believed that the main causes of AIH may be linked to a combination of genetic factors and environmental factors. The environmental factors include viruses, toxin, drugs, and so on. As for the drugs, studies show that minocycline, interferon, statins, clometacin, and infliximab can induce hepatocellular injury in genetically predisposed patients. The onset time of druginduced autoimmune hepatitis (DAIH) is 2~24 months after medication. About 80%~90% of patients are women. The manifestations of DAIH are fatigue, anorexia, and upper abdominal discomfort, jaundice, hepatomegaly accompanied by fever, skin rash, and arthralgia. The clinical characteristics are as follows: lower frequency; dose independence; a long interval between initiation of drug therapy and disease development; hypergammaglobulinemia and high titer of autoantibodies (such as ANA and ASMA). Currently, the most effective therapy for DAIH is immune suppression. Most patients' condition improves after treatment with glucocorticosteroid alone or in combination with azathioprine.
  • 实验论著
    Jin Yong; Liu Shumin; Liu Ying; Mou Hong
    . 2010, 12(1): 17-4.
    Objective: To study the toxic effects of ethyl acetate, nbutanol, and water extracts from 65% alcohol extractions of cocklebur fruit on liver in rats in order to provide a basis for a further investigation of the toxic constituents of cocklebur fruit (Fructus Xanthii). Methods:Twentytwo kilogram of ground cocklebur fruit was macerated in 8-fold amounts of 65% alcohol for 6 hours, and then was extracted by heating under a reflux condenser for 2 hours. The total number of extracting was two times. The alcohol extractions were combined, and the alcohol were retrieved with vaccum distillation till no smell of alcohol. The extractions were concentrated further. The concentrated solution was extracted with petroleum ether, followed by retrieval of petroleum ether. The extractions were extracted with ethyl acetate and nbutanol in turn. The solvents were retrieved and then the water layer was evaporated to dryness with vaccum evaporator. Four point eight gram of ethyl acetate extracts, 24 g of nbutanol extracts,and 56 g of water extracts were mixed with 2000 mL of normal saline solution containing 3% Tween80, respectively. The concentration of the suspensions were 0.0024, 0.012, and 0.028 g/ml, respectively. Forty SPF male rats were randomly divided into 4 groups and each group comprised 10 rats. The three drugexposed groups were gavaged with 2.5 mL of ethyl acetate, nbutanol, and water extract suspensions twice daily, respectively (the dosage was 0.06 g/kg, 0.3 g/kg, 0.7 g/kg daily, respectively). The empty control group was gavaged with same volume of normal saline solution containing Tween80 twice daily. The duration of gavage was 28 days. The appearance, diet, and activities of rats were observed. The body weight of the rats were weighted before drug administration and 14, 21, and 28 days after drug initiation. On day 29, serum levels of ALT, AST, AKP, TBil, and DBil were measured. Subsequently, the rats were sacrificed and the liver index was calculated and changes in histomorphology were observed. Results: The rats in the water extract group developed lusterless fur and decrease in diet and activities 7 days after drug initiation. The rats in the nbutanol extract group developed lusterless fur and listlessness 14 and 21 days after drug initiation as well as erect hair and lassitude 28 days after drug initiation. The rats in the ethyl acetate extract group had no marked changes. The body weight of rats in the nbutanol extract group were (240.6±24.1) and (255.1±21.3)g 21 and 28 days after drug initiation, respectively. The body weight of rats in the water extract group were respectively (214.2±20.5),(230.7±21.2), and (239.1±18.5)g 14, 21, and 28 days after drug initiation, and their body weight were all lower than that of the rats in the empty control group at the same time points [(251.7±27.2),(280.7±38.2), and(306.2±36.5)g, (P<0.05, P<0.01)]. The AST levels in the nbutanol extract group was(112.6±24.3)U/L, which was marked higher than that [(79.9±20.4)U/L] in the empty control group ( P<0.01). The levels of ALT, AST, and AKP in the water extract group were respectively (51.1±3.9),(112.9±16.6), and (198.4±41.8)U/L, which were marked higher than those [(44.3±6.2), (79.9±20.4) and (152.2±39.9)U/L] in the empty control group (P<0.05, P<0.01). The liver indexes in the ethyl acetate extract and water extract groups were respectively 4.71±0.89, and 5.80±0.64, which were marked higher than that (3.14±0.33) in the empty control group (P<0.01). The levels of TBil and DBil in all the drugexposed groups increased, but there were no statistically significant differences(P>0.05). In the nbutanol extract and water extract groups, the pathological changes such as enlarged hepatic cell space, karyolysis, and inflammatory cell infiltration were observed under the light microscope. Conclusion:The nbutanol extracts and water extracts from alcohol extractions of cocklebur fruit have marked hepatotoxicity to rats.
  • 病例报告
    Chen Yingjie;Zhang Lai
    . 2007, 9(5): 358-359.
    A 30-year-old man with upper respiratory tract infection received IV cefradine 1.0 g without skin test.Half an hour later,he developed generalized skin rash with pruritus.After anti-anaphylaxis therapy,his symptom relieved slightly.On day 3,the patient developed asthenia,anorexia,nausea,dark urine,and yellowing of the skin and sclera.Laboratory test revealed the levels as follows:ALT 235.4 U/L,AST 264.1 U/L,γ-GT 175.5 U/L,ALP 239 U/L,Tbil 283.7 μmol/L,Dbil 176.3 μmol/L,CHE 2 153 U/L,and Cr 271.2 μmol/L.He received liver-protective,anti-inflammatory,and symptomatic treatment.Forty days later,his symptoms resolved,and his blood biochemistry values returned to normal limits.
  • . 2015, 17(6): 449-452.
    Bevacizumab, a monoclonal antibody to vascular endothelial growth factor,has been used in the treatment of colorectal cancer, lung cancer, breast cancer, kidney cancer, and glioblastoma, etc. Gastrointestinal perforation (GIP) is a serious and unusual adverse reaction induced by bevacizumab. The incidence of GIP is different due to different types of tumor .The clinical manifestations of GIP are related to perforation site. The main symptoms include abdominal pain, nausea, vomiting, fever, pelvic pain, diarrhea and symptoms of urinary tract infection due to colon-ureter fistula. The risk factors of GIP induced by bevacizumab include age, dosage, history of past illness, primary tumor type and combination of medications. The mechanisms of GIP induced by bevacizumab are inhibition of clotting factors,inhibition of intestinal wall cells′ proliferation and healing, inducing tumor cell death, and reducing intestinal stability. The treatment of GIP induced by bevacizumab are surgical or non-surgical therapy, the latter include antibiotics and total parenteral nutrition. The patient with GIP cannot receive bevacizumab again.
  • . 2017, 19(4): 289.
  • Ma Jie, Wang Nan, Liu Min, Song Yanqing
    Adverse Drug Reactions Journal. 2021, 23(10): 552-554. https://doi.org/10.3760/cma.j.cn114015-20201230-01302
    A 56-year-old male patient was scheduled to undergo debridement due to his left forearm trauma, and functions of his heart, liver, and kidney were normal. Before operation, human tetanus immunoglobulin 250 U was injected intramuscularly without discomfort; 80-minutes later, intravenous infusion of levofloxacin hydrochloride injection was started. After 2-minutes of infusion (approximately 8-ml), the patient had sudden dyspnea, dysphoria, and vomiting. His blood pressure could not be measured due to agitation and blood oxygen saturation was 0.82. Levofloxacin was immediately stopped and electrocar- diographic monitoring and oxygen inhalation were given. But the patient became unconscious, his heart rate dropped to 50 beats/min, and blood pressure was 71/45-mmHg. Immediately, cardiopulmonary resuscitation was performed, and epinephrine, dexamethasone, etc. were given. Anaphylactic shock caused by levofloxacin was considered and type Ⅱ respiratory failure appeared, he was transferred to the Intensive Care Unit to assist breathing with an invasive ventilator. Laboratory tests revealed cardiac troponin T 0.253-mg/L, myoglobin >3-000-mg/L; aspartate aminotransferase 1-079-U/L, alanine aminotransferase 798-U/L, γ-glutamyl transpeptidase 157-U/L; serum creatinine 157 μmol/L. It was considered that the patient developed multiple organ dysfunction syndrome. Continuous hemofiltration, symptomatic treatments such as liver protection, and nutrient therapy for myocardium were given. After 9 days, the patient was detached from the respirator; after 13 days, hemofiltration was stopped; after 29 days, the patient′s mind became clear and the laboratory indexes of heart, liver and kidney returned to normal.
  • Xue Shuyi, Chen Xiaolin, Gong Jing, Zhang Guanmin, Zhang Yanhua, Yin Yue
    Adverse Drug Reactions Journal. 2023, 25(8): 508-510. https://doi.org/10.3760/cma.j.cn114015-20220721-00658
    A 66-year-old male patient with malignant melanoma received combined treatments with apatinib (oral 250 mg once daily),temozolomide (oral 500-mg on day 1 and 400-mg/d on days 2-4),toripalimab(240 mg intravenous infusion on days 1 and 15). After 5 cycles (28 days as a cycle), the patient developed multiple rashes, which were not alleviated after reducing the dose of apatinib to 250-mg orally once every 3 days in the 6th treatment cycle. Laboratory tests showed that serum albumin was 28.5-g/L, total serum protein was 55.5-g/L, eosinophil percentage was 0.096, and venous potassium was 3.17-mmol/L. Erythroderma caused by combination of apatinib and toripalimab was considered, and the 2 drugs were stopped. The patient received the treatments of methylprednisolone,loratadine,diphenhydramine,tria- mcinolone acetonide and econazole nitrate cream and mupirocin ointment (external coating), and skin care. At the same time, symptomatic treatments such as protein supplement, diuresis, potassium supplement, and stomach protection were given. After 10 days of treatments, the rash subsided, and desquamation and itching were improved.
  • Cui Yali, Yu Jindong
    . 2016, 18(3): 227.
    A 55-year-old male patient with acute peripheral facial paralysis received an IV infusion of Shuxuening(舒血宁) injection 20 ml+0.9% sodium chloride 250 ml once daily; prednisone 15 mg, vitamin B110 mg, and mecobalamin 0.5 mg thrice daily by mouth; and decoction of Traditional Chinese Medicine once daily. Three hours after administration of the medicine, he developed polyuria, 6 times within 5 hours with about 500 ml each time. At the same day, prednisone, vitamin B1, and mecobalamin were stopped by himself and decoction was taken continuously, then his urine output decreased. On the second day morning, prednisone was taken and other drugs were stopped, polyuria reappeared. On the third day, prednisone was stopped and other drugs were taken, the patient′s polyuria disappeared. It was considered that the polyuria was induced by prednisone.
  • 安全用药
    Xia Jinghong;Liu Shuang;Li Hong
    . 2010, 12(3): 183-5.
    Clostridium difficileassociated diarrhea (CDAD) mainly occurs in association with the administration of broadspectrum antibiotics. The incidence of CDAD has been trending upward. The antibiotics frequently implicated in Clostridium difficileassociated diarrhea are amoxicillin, clindamycin, lincomycin, cephalosporins. The time to CDAD onset generally is 5-10 days after antibiotics treatment. CDAD in inpatients is 15%~25% of antibacterialassociated diarrhea(AAD) patients and the mortality is about 6%~30%. The mechanism of the occurrence of CDAD is that antibiotics inhibit normal gastrointestinal flora and enable Clostridium difficile to multiple and release toxin A (enterotoxin) and toxin B (cytotoxin) that induce intestinal mucosal injury as well as degeneration, necrosis, and fibrinous exudation of epithelial cells, leading to diarrhea and other symptoms. Clinical presentations mainly include diarrhea(watery stools), fever, abdominal pain, colitis, pseudomembranous (PMC), toxic megacolon, sepsis, and even death. The risk factors for CDAD are the elderly, serious underlying diseases, a prolonged hospitalization, administration of broadspectrum antibiotics and weakened immune function. If CDAD is confirmed, the suspected antibiotics should be withdrawn and metronidazole or vancomycin could be given. The patients with relapse may be treated with another 10~14 days course of metronidazole or vancomycin. The patients with multiple relapses may be treated with cholestyramine, probiotics, and human immulloglobulin.
  • Wang Kehua, Guo Qiongjie, Wang Na
    Adverse Drug Reactions Journal. 2024, 26(3): 157-161. https://doi.org/10.3760/cma.j.cn114015-20231218-00894
    Objective To understand the adverse event (AE) risk signal of doxycycline in children and provide reference for the safe use of the drug in clinic. Methods AE reports of children with doxycycline as primary suspect drug were collected from the US FDA Adverse Event Reporting System (FAERS) database during the 1st quarter of 2004 to the 3rd quarter of 2023. AEs were standardized and classified according to the preferred term (PT) and system organ class (SOC) in Medical Dictionary for Regulatory Activities 26.1. The AE risk signals of doxycycline were mined using reporting odds ratio (ROR) method. An AE with reports ≥3 and the lower limit of the 95%CI of ROR >1 was defined as a risk signal. Descriptive analysis on the risk signals was performed. Results A total of 637 AE reports related to doxycycline in children were collected, involving 107 PTs and 21 SOCs. The top 10 PTs in the number of reports (including juxtaposition) were vomiting, depression, dysphagia, Jarisch-Herxheimer reaction, cholangitis sclerosing, headache, colitis ulcerative, oesophageal ulcer, nausea, oesophagitis, and suicidal ideation. Among them, depression, Jarisch-Herxheimer reaction, cholangitis sclerosing, colitis ulcerative and suicidal ideation were not recorded in labels. The top 10 PTs in signal intensity were Jarisch-Herxheimer reaction, photoonycholysis, hypnopompic hallucination, oesophageal ulcer, oesophageal injury, hypnagogic hallucination, vitritis, onycholysis, cholangitis sclerosing, erosive oesophagitis. Among them, Jarisch-Herxheimer reaction, hypnopompic hallucination, hypnagogic hallucination, vitritis and cholangitis sclerosing were not recorded in labels. Psychiatric disorders were not covered by adverse reactions in the label. Conclusions The main AEs of doxycycline in children are vomiting, dysphagia, oesophageal ulcer, nausea, oesophagitis, all of which are recorded in the drug label. In addition, doxycycline may also cause AEs that are not recorded in drug label, such as Jarisch-Herxheimer reaction, sclerosing cholangitis, ulcerative colitis, and psychiatric disorders.
  • 安全用药
    Wang Hongbao;Guo Lin;Guan Yongbiao*
    . 2010, 12(2): 109-5.
    Puerarin is a kind of isoflavones extracted from dried roots of Pueraria lobata (Willd.) Ohwi or Pueraria thomsonii benth.. Puerarin injection is used in the treatment of cardiovascular and cerebrovascular diseases. In recent years, reports about acute intravascular hemolysis induced by puerarin injection have increased. By searching domestic related literature between 1993 and 2005, 32 patients with puerarin injectioninduced acute intravascular hemolysis were collected. They comprised 21 men and 11 women with average age of (69±9) years. Of them, 10 patients died with average age of (72 ± 5) years. Of 25 patients with complete data, 21 patients received puerarin injection alone and 3 received combination therapy; and intravenous infusion of puerarin 100700 mg dissolved in 0.9% sodium chloride or 5% glucose was given; the duration of drug use was 5-10 days in 22 cases and >10 days in 3 cases. The clinical manifestations of intravascular hemolysis were mainly lumbago, backache, hematuria, oliguria, hemoglobinuria, increased reticulocyte count(0.05-0.30), and hyperbilirubinemia(29.1-123.2μmol/L).Twentytwo patients’symptoms disappeared or stabilized after stopping drug therapy and giving glucocorticoid, antihistamines or hemodialysis treatment. The possible factors for puerarin injectioninduced intravascular hemolysis were the quality of puerarin injection, allergic diathesis and age of patients, duration of drug use, and combination therapy. The mechanism may be related to immune and nonimmune response induced by puerarin injection or its promoting oxidative reaction. The preventive measures are as follows: puerarin injection should not be given to patients with allergic history; the dosage should be adjusted to patients with advanced age, renal and hepatic insufficiency; concomitant use with drugs that may cause hemolysis should be exercise with caution.
  • 综述
    . 2000, 2(2): 73-76.
    催乳素由下丘脑催乳素释放因子和催乳素释放抑制因子调节,生理情况下抑制性影响占优势。引起高催乳素血症的原因有多种,药源性因素是其中之一。本文对可引起高催乳素血症的药物进行了概述,并给出了预防和处理药物引起的高催乳素血症可供选择的几种方法。
  • 学术论坛
    Zhou Chaofana;Lin Yuhuab
    . 2008, 10(3): 184-6.
    Cinnabar (Zhusha) has a history of two thousand years and more as a traditional Chinese medicine, and it was included in each edition of Chinese Pharmacopoeia from 1963 to 2005. Cinnabar is mainly used for treatment of palpitation and terror, insomnia and dreaminess, epileptic seizure, infantile convulsion, blurred vision, aphtha, inflammation of throat, and ulcer and swelling of the skin. Recent studies suggest that cinnabar has sedative, hypnotic, anticonvulsive, antiarrhythmic, antibacterial, and antiparasitic effects. Daily dosage of cinnabar is 0.1~0.5 g in Chinese Pharmacopoeia. However, according to incomplete statistics, the commonly used dosage of about 170 cinnabar preparations exceeds the dosage limit in Chinese Pharmacopoeia. The main composition of cinnabar is mercuric sulfide (HgS). Despite lower toxicity of mercuric sulfide, acute or chronic poisoning can occur after high dosage or longterm use of cinnabar. And it might be related to free mercury or soluble mercuric salts in cinnabar. The presentations of cinnabar poisoning were oral mucosal ulcer, acute gastroenteritis, neurological and renal damage, circulatory failure, and death. The authors suggest that the scientific reassessment of its benefit and risk in clinical practice should be performed on the basis of a thorough investigation and study in the efficacy and safety of cinnabar and its preparations.
  • 论著
    Shi Jun;Luo Leiming;yang Xue;Xue Hao;Liu Guoshu
    . 2005, 7(2): 91-94.
    Objective: To study plasma-potassiun concentration affected by benazepril and spironotactone combination in CHF patients with or without chronic renal failure. Methods: 60 CHF patients without CRF(CHF/ CRF-)and 24 CHF patients with CRF( CHF/CRF+)were chosen to receive benazepril or benazepril plus spironolactone therapy. The changes of plasma- potassium concentration and incidence of hyperkalaemia were followed up and investigated. Results: The plasma- potassium concentration was increased after two weeks therapy in all patients(p < 0.01). Compared with single benazepril therapy benazepril and spironolactone combination induced significant increase of plasma-potassium concentration in patients with CHF/CRF+ (P< 0.01) but not in those with CHF/CRF-(P > 0.05). With the same combination therapy the plasma-potassium concentration was higher in patients with CHF/CRF+ than in those with CHF/CRF- (P< 0.01). Although incidence of hyperkalaemia was 33% in CHF/CRF+ patients receiving the combination therapy, differences compared with the other were not of significance. Conclusion: Application of benazepril and spironolactone combinatim is safe for CHF patients without CRF, and the incidence of hyperkalaemia is lower. But in those with CRF, there is a risk of hyperkalaemia. The cautions should be given to those receiving combination therapy to prevent them from hyperkalaemia.
  • 调查研究
    Li Qing;Leng Jinhua
    . 2002, 4(4): 221-223.
    Objective: To determine ADR occurrence associated with quinolones in clinical practices. Method: ADR reports received by the monitoring center in our hospital were processed and analysed. Results: Nine drugs of quinolones were involved in 150 ADR case reports. The ADR manifestations mainly covered rash, phlebitis, and troubles in alimentary system, cardiovascular system and nervous system. Conclusion: Quinolones can cause unwanted reactions, even serious ones. The solution for the problem is the withdrawal of drug and the use of expectant treatment.
  • ADE简报
    . 2000, 2(1): 61-61.
  • 论著
    Cao Min;Wu Bin;Ma Ding;Bai Yu;Liu Shumin
    . 2011, 13(5): 287-7.

    Objective: To observe the effects of Fructus Xanthii on urinary metabolic profile and overall characterization and blood biochemical indicators in rats in order to explore the application of metabolomics method in evaluation of toxicity in traditional Chinese medicine. Methods: Thirty male Wistar rats were divided into the low-dose group, the high-dose group, and the control group using random-digital table method, each group comprised 10 rats. The rats in the low-dose and high-dose groups were gavage-fed a certain volume of suspension containing aqueous extract of Fructus Xanthii (equivalent to crude drug 1.05 and 21.0 g/kg) once daily for 28 days, respectively. The rats in the control group were gavage-fed the same volume of 0.9% sodium chloride solution. The changes in body weight, coat, movement and mental status in rats were observed during the drug administration. The serum levels of ALT and AST were measured before drug administration and 7,14,21,and 28 days after drug administration, respectively. A 24-hour urine sample of each rat was collected and the metabolic profiles and the overall characterization were determined using ultra-high performance liquid chromatography/time of flight mass spectrometry. Results: The rats in the high-dose group developed lusterless fur, depilation, decrease in food ingestion and activities, and unresponsiveness during the drug administration. Only 2 rats in the low-dose group developed lassitude and lusterless fur 28 days after drug dministration. Twenty-one and 28 days after drug administration, the body weight of rats in the high-dose group were markedly lower than that in the low-dose group (P<0.05) and the control group (P<0.01), but the differences in body weight between the low-dose group and the control group was not statistically significant in each time point ( all P>0.05). Twenty-one days after drug administration, the levels of ALT and AST in the high-dose group[( 42.9±3.9)U/L, (107.9±12.7)U/L]were markedly higher than those in the low-dose group [( 33.8±4. 4)U/L, (95.8±16.6)U/L]and the control group[( 31.8±4.4)U/L, (93.5±15.8)U/L], the differences were statistically significant ( all P<0.05). Twenty-eight days after drug administration, ALT and AST in the high-dose group reached peak levels. There was no statistically significant difference in ALT and AST levels between the low-dose group and the control group in each time point (all P>0.05). The distributions of 24-hours’urine metabolite phenotypic clustering 7, 14, 21 and 28 days after drug administration in the high-dose group were deviated from the control group, and the deviation increased with the prolonged drug administration. The distributions of 24-hours’urine metabolite phenotypic clustering 7, 14 and 21 days after drug administration in the low-dose group were near and partly overlapped with those of the control group, but a single cluster appeared 28 days after drug administration. Conclusion: The metabolomic method has higher sensitivity in detection of Fructus Xanthii-induced hepatotoxicity and might be used in the toxicity evaluation of traditional Chinese medicine.

  • Xia Fan, Bao Qi, Tan Yanhong, Gao Jie
    . 2016, 18(5): 337.
    ObjectiveTo explore preventive function of glutathione against liver injury caused by high-dose methotrexate (HD-MTX).MethodsData of patients with hematological malignancy and receiving HD-MTX therapy in the First Affiliated Hospital of Soochow University between Jan, 2013 to Mar, 2016 were retrospectively analyzed. The chemotherapy schemes included MTX alone (scheme 1), MTX with cytarabine (scheme 2), and MTX with vindesine (scheme 3). The patients were divided into 2 groups, the glutathione group and the control group. The liver injury in the 2 groups were analyzed.ResultsA total of 123 patients were enrolled in the study. Of them, 25 males and 25 females were in the glutathione group and their median age was 38 years (7 to 62 years), 43 males and 30 females were in the control group and their median age was 25 years (7 to 61 years). One hundred and twenty-three patients received a total of 155 times of HD-MTX therapy. Fifty patients in the glutathione group received 57 times of HD-MTX therapy (16 times in the 13 patients, 22 times in the 21 patients, and 19 times in the 16 patients in the scheme 1, 2, and 3, respectively); 29 times of liver injury occurred in the 27 patients (6 times in the 5 patients, 13 times in the 13 patients, and 10 times in the 9 patients in the scheme 1, 2, and 3, respectively); 73 patients in the control group received 98 courses of HD-MTX therapy (38 courses in the 23 patients, 37 courses in the 30 patients, and 23 courses in the 20 patients in the scheme 1, 2, and 3, respectively), 51 times  of liver injury appeared in the 40 patients (18 times in the 11 patients, 23 times in the 20 patients, and 10 times in the 9 patients in the scheme 1, 2, and 3, respectively). There were no significant differences in the incidence of liver injury between the 2 groups and among the 3 chemotherapy schemes (all P>0.05). There was no significant difference in theⅠ-Ⅳ grade of liver injury between the 2 groups (P=0.772). The types of liver injury in the scheme 1 and scheme 2 were mixed [58.3% (14/24) and 50.0% (18/36), respectively], and the type of liver injury in the scheme 3 was cholestatic [50.0%(10/20)].ConclusionPreventive treatment with glutathione in the patients with hematological malignancy could not reduce the incidence of liver injury caused by high-dose methotrexate.
  • 调查研究
    Yang Liming①;Lu Ping①; Wang Liran②; Wang Qipeng①; Guo HongYan①; Yang Yanping①
    . 2004, 6(1): 11-14.
    Objective: To investigate the effects of both dialysis and drug treatme nt on mannitol-induced osmotic nephrosis. Method: 53 cases aged 25-81 with manni tol-induced osmotic nephrosis were treated with a combination therapy of drugs and individualized hemodialysis/ peritoneal dialysis. Results: After treatment , much improvement occured in 48 cases, that is, gradual disappearance of sympto ms, normalized urinary output, serum creatinine and blood urea nitrogen decreas ed from 1934.8ìmol/L and 49 mmol/L to normal level respectively. Conclusion: P roper dialysis and drugs therapy could produce a satisfactory effect on mannitol-induced osmotic nephrosis.
  • 病例报告
    Zhang Haiying;Shi Xiaowei;Li Yuzhen
    . 2008, 10(6): 0-0.

    A 46-year-old woman was hospitalized with tuberculous pleurisy. She was treated orally with rifampicin 450 mg once daily, isoniazid 300 mg once daily, pyrazinamide 500 mg thrice daily, and ethambutol 750 mg once daily. Her platelet count was 335×109/L before treatment. After 14 days of therapy, her platelet count decreased to 1.8×109/L, and the dense bleeding points and ecchymoses occurred on her skin of extremities and abdomen. Rifampicin was withdrawn, and platelet transfusion and methylprednisolone treatment was given. The other therapy remained unchanged. One week later, her platelet count increased to 1642×109/L.

  • 滥用误用
    Li Hong;Ren Aimin
    . 2011, 13(2): 103-2.
    A 19yearold man with infectious mononucleosis was prescribed an IV infusion of aciclovir 600 mg in 10% glucose 250 ml but, due to a medication error, he received an IV infusion of aciclovir 3.0 g in 10% glucose 250 ml. Nine hours after infusion completion, he developed marked lumbago, oliguria, 2+ urine protein, and 2+ urine occult blood followed by a 24hour anuria period. On day 3, his renal function tests revealed a serum creatinine level of 557 μmol/L and a urea level of 9.2 mmol/L. Renal ultrasonography showed diffuse bilateral renal lesion. He received blood purification and an IV infusion of methylprednisolone 40 mg/d for 2 days. His renal function improved and urine volume increased. On day 15, both his renal function and routine urine tests returned to normal and he was discharged with complete recovery.
    KEY WORDSaciclovir; acute renal failure
  • Zhang Qingxia, Zhu Yidan, Liu Baojing, Xu Xin, Lu Yun
    Adverse Drug Reactions Journal. 2022, 24(4): 197-202. https://doi.org/10.3760/cma.j.cn114015-20211020-01081
    Coronavirus disease 2019 (COVID-19) can increase the risk of thrombosis and arterial embolism events in patients. The more serious the condition, the higher the risk. Therefore, many academic groups at home and abroad have successively issued guidelines on the prevention and treatment of throm- bosis in patients with COVID-19. Among them, American Society of Hematology 2021 guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19 (ASH guidelines) and its updates are newer and have more detailed recommendations on the application of anticoagulant drugs to prevent venous thromboembolism in acutely and critically ill patients with COVID-19. This review aims to provide reference for clinic through general viewing the ASH guidelines as well as other relevant guidelines at home and abroad.
  • Yan Jiaju, Zhang Yuping
    Adverse Drug Reactions Journal. 2023, 25(7): 439-441. https://doi.org/10.3760/cma.j.cn114015-20220718-00645
    A 57-year-old male patient with brain metastases after radical resection of adenocarcinoma of the lung and adjuvant chemotherapy received anlotinib 12-mg orally once daily (2 weeks on and 1 week off) combined with temozolomide 150-mg orally once daily (3 weeks on and 1 week off). After 5 months of treatments, the patient developed symptoms such as cough, chest tightness, and exertional dyspnea, which gradually worsened. No obvious abnormalities were found in laboratory tests, electrocar- diogram, or cardiac echocardiography. Chest CT examination showed interstitial pulmonary edema in bilateral lungs, which was considered to be related to anlotinib. Anlotinib and temozolomide treatments were stopped and glucocorticoid and symptomatic treatments were given. Five days later, the patient′s cough, chest tightness, and other symptoms were relieved. Anlotinib was replaced by bevacizumab, which was combined with temozolomide to continue the anti-tumor treatment, and the patient did not experience discomfort. One month later, chest CT showed that the interstitial edema in bilateral lungs was markedly absorbed.
  • 中毒救治
    Gao Lehong;Sun Wei
    . 2010, 12(5): 333-2.
    Four patients with asthma, 2 men and 2 women aged 54-65 years, received 4-9 compound phenytoin sodium, ephedrine hydrochloride and theophylline tablets daily, each tablet contains phenytoin sodium 50 mg, the total daily dosage of phenytoin sodium was 200-450 mg, and the duration of treatment was 1-4 years, they developed dizziness, nystagmus, gait instability and signs of cerebellar ataxia during treatment. Laboratory tests showed that the blood phenytoin concentrations were 34.15-94.12 μg/mL and that were 1.4-4.7 times the therapeutic blood concentration. They were diagnosed with phenytoin poisoning. The tablets were discontinued. Four to seven days later, their manifestations mentioned above disappeared. On reexamination, two patient’s blood phenytoin concentrations decreased to 1.03 μg/mL and 1.14 μg/mL, respectively.
  • 药源性疾病
    SUN Zhen-xiao;YU Xiang-fen
    . 2012, 14(1): 34-5.

    Objective: Tardive dystonia (TDt) is one of extrapyramidal symptoms that starts after long-term use of antipsychotic drugs. It has been reported that the incidence of TDt ranged from 2.7% to 5.3%. Its main clinical feature is that voluntary movements of one or more voluntary muscles are difficult, or abnormal postures because of difficult voluntary movements. The mechanism of TDt is generally considered to be associated with postsynaptic dopamine receptor supersensitivity caused by sustained inhibition of the dopaminergic neurotransmission or anti-noradrenergic effect of antipsychotics. TDt should be distinguished from acute dystonia, tardive dyskinesia, idiopathic dystonia, secondary dystonia, familial dystonia and conversion symptoms. Once TDt developed, dopamine receptor antagonists should be stopped, atypical antipsychotic drugs or other drugs or deep brain stimulation could be used. Symptoms might improve after such treatment.

  • 安全合理用药
    . 2007, 9(2): 103-105.
    肿瘤坏死因子-α抑制剂(TNF-αI)etanercept、infliximab和adlimumab能有效治疗类风湿性关节炎、强直性脊柱炎和炎性肠病,对银屑病和银屑病关节炎有极好的临床疗效,并能有效控制银屑病皮疹、肌腱端炎和指(趾)炎。但是肿瘤坏死因子-α抑制剂也有少见的不良反应能够诱发银屑病和掌跖脓疱病,已发生40余例。本文探讨TNF-αI产生这种双相作用的原因。
  • 病例报告
    Du Hui;Huang Wei
    . 2014, 16(1): 46-3.

    A 28-day-old male neonate received paracetamol half a bag (about 0.125 g) by his parents for 2 days of wheezing and one day of fever. Half a day later, the neonate′s symptoms worsened. Physical examination showed the following results: temperature 38.1 ℃, heart rate 273 beats/min, respi-ratory rate 43 breaths/min, nodding-like breathing, lip cyanosis, 3-retraction sign (+), wet and dry rales in bilateral lungs, abdominal distention, and the liver edge palpated at 6 cm below the right costal margin. Laboratory examination showed the following levels: alanine aminotransferase (ALT) 979 U/L, aspartate aminotransferase (AST) 1 661 U/L, alkaline phosphatase (ALP) 469 U/L, gamma-glutamyl transpeptidase (γ-GT) 158 U/L, glutamyl dehydrogenase (GLDH) 294 U/L, lactate dehydrogenase (LDH) 2 989 U/L, α-hydroxybutyrate dehydrogenase (α-HBDH) 1 141 U/L. Neonatal pneumonia combined with heart failure and acute liver injury were diagnosed. Anti-inflammatory, antiviral, liver-protection, and enzyme reducing therapy were given. Seven days later, reexaminations showed the following results: ALT 72 U/L, AST 32 U/L, ALP 244 U/L, GGT 128 U/L, GLDH 31 U/L, LDH 262 U/L.

  • Liu Yunxing, Shu Qing, Yang Xian, Yao Yao, Wang Hong, Zhao Cheng, Ge Weihong
    Adverse Drug Reactions Journal. 2020, 22(5): 319-320. https://doi.org/10.3760/cma.j.cn114015-20190801-00628
    A 58-year-old female patient received cyclosporine 75-mg twice daily orally for dermatomyositis. Seven days later, the patient developed chest pain and dyspnea suddenly. Her oxygen saturation was 79% and the blood pressure was 190/125-mmHg. Laboratory tests showed her brain natriuretic peptide (BNP) 1 470.0 ng/L. The electrocardiogram showed a tall and sharp T-wave in the precordial lead. Chest X-ray showed enlarged heart shadow and suffused shadow in the right lung. The patient was diagnosed as acute left ventricular failure, which was considered to be related to cyclosporine. Cyclosporine was discontinued immediately. After the treatments with oxygen inhalation and IV infusions of methylprednisolone 80-mg and IV injection of furosemide 80-mg for 8 days, her symptoms improved and the BNP decreased to 318.0 ng/L. Then she received tacrolimus 2-mg twice daily orally for dermatomyositis. On day 2 of dermatomyositis treatment, she felt chest tightness and her BNP increased to 1-010.0 ng/L. Lefe ventricular failure induced by tacrolimus was considered. Tacrolimus was stopped immediately and the symptomatic treatments such as diuresis were given. On day 3 of dermatomyositis withdrawal, her chest tightness disappeared and the BNP decreased to 57.5 ng/L.
  • 调查研究
    Yuan Jin;Yao Xiaoli
    . 2007, 9(2): 100-102.
    Objective: To understand the occurrence and clinical features of seizures induced by fluoroquinolones. Methods: The reported cases with seizures induced by fluoroquinolones from CBMdisc (1978-01-2006-06) and CHDL(1994-01-2006-06) were collected and analyzed. Results: Fifty-four patients with fluoroquinolones-induced seizures (31 males, 23 females) were collected. Five of them had a previous history of epilepsy. The common causative medications, in the order of frequency, were ciprofloxacin, ofloxacin, levofloxacin, norfloxacin, and so on. Forty three patients were administered intravenously, and 7 patients were administered orally. Six patients were coadministered with theophylline-containing preparations. Of the 54 patients, 47 were generalized tonic-clonic seizures, 7 were partial seizures. The time of onset of seizures was 10 min to 6 d after fluoroquinolones use. The duration of seizures was 20 s to 10 min. The seizure frequency was 1 to 5 times. After drug withdrawal or systematic…更多 therapy, all the patients had recovered and were discharged, except one patient died from neurospongioma and cerebral infarction. Conclusion: Seizures might be induced by intravenous or oral administration of fluoroquinolones. Clinicans should be aware of the risks of fluoroquinolones-induced seizures in order to be beneficial to safe drug use.
  • 论著
    Zhang Liwei①;Luo Beijie①;Song Yan②;Huang Dangshen①;Shen Dong①;Zhang Xiuwen①
    . 2007, 9(5): 316-319.
    Objective:To study the efficacy and safety of domestic recombinant human brain natriuretic peptide(rhBNP)for treating acute decompensated heart failure.Methods:The clinical data of 15 inpatients with acute decompensated heart failure from January 2005 to March 2006 were collected.The patients received rhBNP 1.5 μg/kg by bolus intravenous injection within 1~3 minutes followed by 0.007 5 μg/(kg·min)for 25.9~46 hours(total dosage 1.0 mg).The changes in BP,HR,respiration rate,urinary output,SCr,BNP,and left ventricular ejection fraction(LVEF)were compared before and after treatment.Results:Dyspnea in the 15 patients was improved in varying degrees.Respiration rate decreased from(35.2±6.1)breaths/min to(24.4±5.0)breaths/min(P>0.05).Urine output increased from(1 452.7±1 611.9)ml/d to(2 149.4±1 279.6)mg/d,and the dose of furosemide was decreased from(86.0±77.2)mg/d to(40.0±28.2)mg/d.Heart rate decreased from(97.4±29.9)beats/min to(79.8±15.0)beats/min(all P<0.05).After 24 hours of stopping rhBNP,the symptoms were improved further(all P<0.05).Ventricular arrhythmia in 2 patients was markedly improved.The patients developed mild blood pressure decreasing,but the difference was no statisticadly significant before and after treatment(P>0.05).There were no changes in SCr,BNP,and LVEF.Three of the 15 patients died in hospitalization.Of the 3 patients,2 cases died from multiorgan failure and 1 case died from ventricular fibrillation.At follow-up of 8~32 weeks,11 cases survived and 1 case died from gastrointestinal hemorrhage.Conclusion:Domestic rhBNP can relieve the clinical symptoms of acute decompensated heart failure.It demonstrates good tolerance in treatment of acute decompensated heart failure.
  • 安全合理用药
    Zhang Wenyan;Yuan Yaozong
    . 2008, 10(3): 190-5.
    Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for treatment of rheumatic and cardiovascular diseases in clinical practice. The most common adverse reactions to NSAIDs are gastrointestinal discomfort, nausea, and severe reactions are peptic ulcer, gastrointestinal bleeding or perforation. The pathogenesis of gastrointestinal injury is that NSAIDs inhibit COX enzyme system, thus blocking the prostaglandin synthesis; in turn, interferes with normal mucosal protective mechanisms, leading to local injury. The risk factors for gastrointestinal injury induced by NSAIDs are old age, a history of peptic ulcers or bleeding of gastrointestinal tract. Ways of preventing NSAIDsinduced gastrointestinal injury include the use of ulcer-preventing drugs, the choice of new high-selective COX-2 inhibitors, the use of antiHelicobacter pylori therapy according the patient's condition, and taking different therapeutic programs based on patientrelated risk factors.
  • 调查研究
    Zhang Yuewen①;Shi Lifeng②;Li Jianping①;Wang Shoudong①;Fang Xiaoyan①;Bai Ming①;Chang Liming③
    . 2005, 7(2): 100-103.
    Objective: To analysis allergic reactions caused by Shuanghuanglian in clinical practice. Methods: 111 cases with allergy due to Shuanghuanglian were collected and analysed from "China Periodicals Net"(2000.12-2004.3). Results: It was shown that Shuanghuanglian-induced allergy was not related to sex and age of patients but related to route of admi-nistration. As for the types of allergy 67 were anaphylactic shock (accounting for 60 %) 61 skin reactions (55 %) 14 the other reactions (13%) and 31 suffered more than one symptoms of allergy. Shuanghuanglian-induced allergy occurred from one minute to three days after administration of the drug and 97 cases (87%) developed the symptoms of allergy in the period of treatment. Conclusion: Immediate hypersensitivity reaction (such as anaphylactic shock)is the common type of allergy associated with Shuanghuanglian.
  • 综述
    . 1999, 1(1): 14-17.
    两种威胁生命的不良反应,原发性肺动脉高压及心瓣膜异常,与芬氟拉明和右芬氟拉明因果相关。本文介绍了自这些不良反应的出现到芬氟拉明和右芬氟拉明从世界撤销的全过程,并介绍了撤销造成的影响以及芬氟拉明和右芬氟拉明不良反应机制研究的新进展。
  • 综述
    . 2006, 8(3): 165-168.
    洋地黄强心苷类药用于治疗充血性心力衰竭(心衰)已有200年的历史,但是人们对它治疗心衰合并窦性心率、左室舒张功能障碍为主的心衰及右心衰竭的作用及其安全性一直存在争议。1997年国外进行的大规模临床对照试验(DIG)对这一问题作出了明确回答,肯定了洋地黄强心苷类药治疗心衰的重要作用。
  • WHO信息
    . 2001, 3(1): 56-56.
  • 论著
    YI Zhan-miao*;LIU Fang;PEI Zhen-e;ZHOU Bing;XING Li-qiu;ZHANG Li-ming. *Department of Pharmacy;Peking University Third Hospital;Beijing 00;China
    . 2012, 14(6): 352-4.
    analyse clinical characteristics, related factors, treatments, and prognosis of myopathy and peripheral neuropathy associated with telbivudine. Methods Reports of myopathy and peripheral neuropathy were selected from reports of serious adverse reactions caused by telbivudine identified from the Beijing Adverse Drug Reactions Monitoring Network database from January 1, 2010 to June 30, 2011. The general information, medication, clinical symptoms, laboratory tests results, treatments, and prognosis in patients with myopathy and peripheral neuropathy caused by telbivudine were analyzed. ResultsA total of 27 reports were entered, involving 27 patients. Of them, there were 25 patients (92.6%) with myopathy and 2 (7.4%) with peripheral neuropathy. The causal relationship between telbivudine and the described adverse reactions was assessed as possible. Of 25 patients with myopathy, 24 were male and 1 was female with an average age of (33±12) years. All patients received telbivudine 600 mg once daily. Duration of medication use were 6-<10 months in 6 patients (24.0%); 10-15 months in 13 patients (520%); >15 months in 6 patients (24.0%). The clinical symptoms were muscular soreness and muscular tenderness. The serum creatine kinase levels in all patients increased (651-14 466 U/L). After telbivudine were stopped and symptomatic treatments were given, one patient was cured, 21 improved (84.0%), and 2 died. One male patient developed rhabdomyolysis and refractory lactic acidosis and then gave up treatment. Two patients with peripheral neuropathy manifested as numbness and paresthesia on their fingertip, toe, and foot; one of them improved after the drug discontinuation and symptomatic treatments, and the other one had not improved at the time of reporting. ConclusionLong-term use of telbivudine can induce serious adverse reactions such as myopathy and peripheral neuropathy. The symptoms improved in most patients after drug discontinuation and symptomatic treatments.
  • Adverse Drug Reactions Journal. 2020, 22(3): 197-200. https://doi.org/10.3760/cma.j.cn114015-20200224-00158
     国家卫生健康委员会和国家中医药管理局发布的《新型冠状病毒肺炎诊疗方案(试行第六版)》首次提出可试用磷酸氯喹治疗新型冠状病毒肺炎(COVID-19)。氯喹治疗病毒感染的作用机制包括通过pH依赖性抑制病毒穿入、脱壳等复制过程而发挥抑制病毒作用;通过干扰病毒黏蛋白与血管紧张素转化酶2的结合而发挥抑制病毒作用以及通过抑制肿瘤坏死因子α等炎性细胞因子表达和细胞自噬作用抑制炎性反应。氯喹治疗冠状病毒感染的研究多为体外试验,目前尚无该药用于COVID-19有效性和安全性评价的临床研究结果。氯喹可导致多个系统或器官的不良反应,包括心血管系统、眼、皮肤、消化系统、神经精神系统、内分泌系统、血液系统和耳等,而且与多种药物存在相互作用。本文对临床用药过程中的药学监护提出了具体建议。
  • ang Zhe, Chai Lina, Yang Dongliang, Qiao Yi, Wen Aidong
    . 2018, 20(1): 53.
    In order to identify the cause for abdominal pain and diarrhea by electronic colonoscopy, one male patient aged 54-year-old took orally polyethylene glycol-electrolyte powder including two bags of agents A and B respectively which were dissolved in 300 ml warm water, and taken 1 time every 20 minutes, for 4 times. Two hours later, many dark red spots with a diameter of 0.5 cm  were scattered on both lower limbs which were partly fused into ecchymosis, with clear boundary and not faded after pressing. Meanwhile the patient developed abdominal paroxysmal colic and the pain site was not fixed. The stool, urine routine and kidney function were urgently examined, and their results were normal. The results of colonoscopy showed that the colonic mucosa was widely edematous and there were scattered spotty and patchy mucosal hyperemia, which were remarkable at descending colon and lower segment. It was considered to be abdominal type Henoch-Schonlein purpura which might be related with polyethylene glycol-electrolyte powder. After glucocorticoid and symptomatic treatment, the abdominal pain disappeared and ecchymosis subsided within 15 days.
  • 病例报告
    Yan Ni;Wang Yirui;Wang Xia;Wu Shenglin;Du Xia
    . 2014, 16(1): 45-2.

    An 82-year-old male patient with coronary atherosclerosis heart disease received iodixanol injection 60 ml for arteriography. On day 2 after operation, the patient developed erythema multiforme and itching. Aspirin, bisoprolol, atorvastatin, and clopidogrel were stopped and anti-allergy treatments were given. Eight days later, the symptoms worsened gradually. Delayed anaphylactic reaction induced by iodixanol was considered. Laboratory examination showed the following results: white blood cell count 10.1×109/L, neutrophils 0.79, eosinophils 0.02, high sensitivity C reaction protein 13.9 mg/L, and procalcitonin 0.189 μg/L. Severe erythema multiforme was diagnosed. The patient′s symptoms improved after treatments with methylprednisolone sodium succinate, sodium fusidate, mouth care (lidocaine+dexamethasone+sodium bicarbonate solution), wet dressing for lip (normal saline+ gentamicin+dexamethasone).

  • 病例报告
    Shen Weimin;Wang Xin;Liu Xiaofeng;Yan Qing;Cao Lei
    . 2007, 9(5): 365-366.
    A 52-vear-old woman was scheduled to undergo right partial thyroidectomy for right thyroid occupying lesion.Preopera- tive electrocardiographic monitoring showed the following records:BP 140/83 mmHg,HR 90 beats/min,ECG normal,pulse oxygen saturation(SpO2) 0.96.She received 20 ml of a mixed solution prepared with 0.75% ropivacaine solution and 2%lidocaine solution in a rafto 0f 1 to 1 for bilateral cervical plexus block. Five minutes after administration,the woman developed palpitation,chest dis- tress,breath holding,mental stress,excitation and logorrhea.His BP was 168/95 mmHg,his HR was 120 beats/min with frequent premature ventricular contraction and occasional bigeming,and his SpO2 was 0.90. And the auscuhation revealed wheezes in the lungs and anlhythmia.After receiving midazolam,lidocaine,dexalnethasone,and oxygen,she recovered gradually.
  • Li Yang, Huo Jiping, Cui Jian, Wang Kai, Ren Shuang, Yang Li
    Adverse Drug Reactions Journal. 2022, 24(10): 522-527. https://doi.org/10.3760/cma.j.cn114015-20220302-00164
    Objective To investigate the effect of drug metabolism related gene polymorphism on the efficacy of clopidogrel in patients with acute coronary syndrome (ACS). Methods The medical records and follow-up records of ACS patients, who were hospitalized in the People′s Hospital of Daxing District between 2017 and 2019, received standardized treatment with aspirin (100-mg/day)+clopidogrel (75-mg/day), and underwent testing for genetic polymorphisms related to clopidogrel absorption/metabolism, were collected. The patients were divided into thrombotic event group and non-thrombotic event group according to whether they experienced thrombotic events such as myocardial infarction, stent thrombosis, and cerebral infarction within 1 year of treatment. The age, gender, smoking history and drinking habits, underlying diseases, drug combination, and alleles related to clopidogrel absorption/metabolism in patients in the 2 groups were compared. The factors affecting the clinical efficacy of clopidogrel was analyzed using logistic regression model. Results A total of 342 patients were included in the analysis, including 274 males and 68 females, aged (58±9) years; of them, 78 (22.8%) developed thrombotic events. The differences in age, gender, smoking history, drinking history, hypertension, diabetes mellitus, hyperlipidemia, percutaneous coronary intervention history, proportion of combined with calcium channel antagonists, cytochrome P450 (CYP) 2C19*3, paraoxonase-1 Q192R, and adenosine triphosphate binding cassette transporter B1 C3435T between the thrombotic event group and the non-thrombotic event group were not statistically significant (all P>0.05), but the body mass index (BMI), the proportion of CYP2C19*2 GG type and CYP2C19*17 CT type in patients in the thrombotic event group were lower than those in the non-thrombotic event group (all P<0.05), and the proportion of patients with proton pump inhibitor and CYP2C19*17 CC type in the thrombotic event group was higher than that in the non-thrombotic event group (all P<0.05). Multivariate logistic regression analysis showed that high BMI (OR=0.915, 95%CI: 0.847-0.989, P=0.026), CYP2C19*2 GG type (OR=0, 95%CI: 0-0.008, P<0.001), and GA type (OR=0.028, 95%CI: 0.003-0.296, P=0.003) were independent protective factors for thrombotic events after clopidogrel treatment; CYP2C19*17 CC type (OR=2-856.665, 95%CI: 87.337-93-436.810, P<0.001) was an independent risk factor for thrombotic events after clopidogrel treatment. Conclusion CYP2C19*2 and CYP2C19*17 mutations are important factors affecting the efficacy of clopidogrel and the occurrence of thrombotic events after treatment in ACS patients.
  • Long Xia, Zeng Xiaohuan, Gan Xiaohong
    Adverse Drug Reactions Journal. 2020, 22(4): 227-232. https://doi.org/10.3760/cma.j.cn114015-20190615-00491
    Objective To explore the risks and influencing factors of regorafenib related hepatobiliary system injury. Methods Reports of regorafenib related hepatobiliary system adverse events received from 4th quarter, 2012 to 3rd quarter, 2018 in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database were collected. The signal intensity of hepatobiliary system adverse events related to regorafenib was screened and statistically analyzed by report odds ratio (ROR) and proportional report ratio (PRR), and their influencing factors were analyzed by logistic regression analysis. Results A total of 26-013 adverse event reports related to regorafenib were retrieved, and 28 preferred terms were screened as suspicious hepatobiliary system related adverse event signals. Results from sorting the signal intensity of adverse events using ROR, PRR and their lower limit of 95% confidence interval (CI) showed that elevation of jaundice and bilirubin had the strongest signal (ROR=8.56, 95%CI lower limit: 7.66; PRR=8.46, 95%CI lower limit: 7.58), followed by other laboratory abnormalities (ROR=6.05, 95%CI lower limit: 4.95; PRR=6.03, 95%CI lower limit: 4.94) and then liver related diseases (ROR=5.46, 95%CI lower limit: 4.71; PRR=5.43, 95%CI lower limit: 4.69). Logistic regression analysis showed that the risk of hepatobiliary system adverse events was higher when the regorafenib dose was>80~<160-mg/d, compared with the dose of ≤80-mg/d (OR=1.702, 95%CI: 1.230-2.356, P=0.001), and was lower in patients with gastrointestinal stromal tumors, compared with other tumors (OR=0.436, 95%CI: 0.240-0.792, P=0.006). Conclusion Regorafenib has the risk of hepatobiliary system injury, and a higher dose may be related to the increased risk.
  • Adverse Drug Reactions Journal. 2020, 22(6): 383-384. https://doi.org/10.3760/cma.j.cn114015-20200615-00686
  • 调查研究
    Huang Huiyi
    . 1999, 1(2): 97-99.
    Objective: To promote the clinical level on diagnosis and therapy of drug-induced hepatitis. Methods: According to the medical history, treatment, clinical symptoms, liver function tests, etiological signs and effects of the drug withdrawal, a comprehensive diagnosis was made for the patients admitted to the hospital from 1994 to 1998 due to suffering from viral hepatitis, and eventually a confirmed diagnosis was made that 36 patients among them were suffered from the drug-induced hepatitis. Results: In 36 cases of drug-induced hepatitis, the traditional Chinese medicines accounted for 15 (41.7%) antituberculotics 8 (22.2%), antibiotics 4 (11.1%), sul-fonamides 1 (2. 78%), and sex hormones, nonsteroidal antiinflammatory drugs, antidiabetics, antineoplastics accounted for 2 (5.56%) separately. 35 of 36 drug-induced hepaiitis cases were a-cutic, and only one case was chronic. Conclusion; the attention should be paid to drug choice, dosage and course of treatment for the patients, especially for the patients with hepatorenal insufficiency, the ADR monitoring should be strengthened, and organic function test should be made regularly in orde to prevent the occurrence of drug-induced hepatitis
  • 学术研讨
    . 2006, 8(2): 88-91.
    本文就基因多态性对抗癫痫药的疗效、药代动力学的影响以及不良反应基因的预测等有关问题作一介绍,旨在加深了解基因多态性及其变异对抗癫痫药敏感性的影响,以提高抗癫痫药的疗效,减少其不良反应的发生。
  • 调查研究
    Shi Yulan;Zhu Min
    . 2005, 7(1): 20-22.
    Objective: To observe the respiratory depression caused by intravenous midazolam . Methods: 129 cases of general anaesthesia were divided into three groups randomly-43 cases each. The cases in 3 groups were given midazolam injection with doses of 0.05-0.1 and 0.15 mg per kg respectively. Respiratory rate(RR)-respiratory volume(RV) and blood oxygen saturation were observed. Results: The RR-RV and blood oxygen saturation of the three groups all descended-with significant differences between groups 2-3 and group 1(P< 0.05). Conclusion: Intravenous midazolam could cause respiratory depression-so an initial dose of 0.05 mg per kg is advisable in clinical practice.
  • 调查研究
    Ma Fubao;Diao Liandong;Tang Fenyang
    . 2004, 6(1): 14-17.
    Objective: To make assessment of reactions after vaccination. Method: T he vaccination reactions reporting system was established in Jiangsu province in 2002. Results: 273 cases of vaccination reactions were reported in 2002 and the major clinical symptoms were systemic rash (51.28%) and local reactions (16.12% ). The reporting peak was in April and May. 13 vaccines caused unwanted effects and Japanese B encephalitis inactivated vaccine and DPT were responsible for 70. 33% and 20.15% of the total cases respectively. Conclusion: To strengthen the va ccination reactions reporting system is beneficial to implementing the planned i mmunization programme.
  • 论著
    Shi Wei;Wu Jinyu;Xie Yongxiang;Li Zhenzhong
    . 2006, 8(4): 254-258.
    Objective:To observe the efficacy of jiaweifuzilizhongtang on the renal function and clinical symptoms of patients with aristolochic acid nephropathy(AAN).Methods:Twenty-seven patients with AAN were treated with jiaweifuzilizhongtang.The observation indexes such as blood urea nitrogen(BUN),serum creatinine(SCr),endogenous creatinine clearance rate(CCr),erythrocyte(RBC),hemoglobin(Hb),twenty-four-hour proteinuria quantitation(24 h Upro),N-acety-β-D-glocosamidase(NAG),Urine Osmole(Uosm),were determined before and after treatment,and the score of patients' symptoms including aversion to cold,cold limbs,fatigue,weakness,anorexia,nausea,pale complexion and lassitude in loin and legs were also calculated.Results:Compared with that of pre-treatment,the renal function of patients after treatment was significantly improved(P<0.05)according to the indexes of BUN,SCr,CCr,RBC and Hb,24 h Upro,NAG,Uosm.Meanwhile,after treatment the score of clinical symptoms was obviously different(P< 0.05)from that of pre-treatment,and the total clinical effective rate was 74.07%.Conclusion:Jiaweifuzilizhongtang is effective for treating the patients with aristolochic acidnephropathy(AAN).
  • 安全合理用药
    Hu Zhonghui;Wang Quanjun;Liao Mingyang
    . 2009, 11(1): 28-3.
    Andrographolide injection (Lianbizhi injection) is an antibacterial and antiinflammatory agent. Recently, andrographolide injectioninduced acute renal injury has been reported, and its potential safety issue has caused widespread concern. The clinical feature of the renal disorder is that the latent period from exposure to onset of symptoms is short and it usually occurs after one dose. The presentations are lumbago, nausea, oliguria, anuria, and an increase in serum creatinine and urea nitrogen. The experimental study has suggested that andrographolide injection has no marked toxic effects on the renal tissue of rats, but administration of large dosage within a short time period may cause renal injury to some extent. Andrographolide injectioninduced nephrotoxicity may be associated with its potential toxicity or allergic reactions. In addition, high concentration or andrographolide injection combined with nephrotoxic drugs may produce renal injury. Clinicians should be aware of the previous allergic history of the patients before the drug use. The concentration and the delivery rate of infusion should be appropriate. Using andrographolide injection in combination with other nephrotoxic drugs should be avoided. The drug should not be used for patients with renal diseases.
  • Huang Wenhui, Chen Qiuhong, Xue Honglin, Zhang Yunchen
    Adverse Drug Reactions Journal. 2021, 23(6): 304-311. https://doi.org/10.3760/cma.j.cn114015-20210315-00304
    Objective To systematically evaluate correlation between the risk of malignancy and dapagliflozin in type 2 diabetes mellitus. Methods The databases such as PubMed, the Cochrane Library, American Clinical Trial Registry, Embase, JAMA, Wiley-Blackwell, Springer Link, Elsevier, Ovid, Taylor & Francis Online, CNKI, Wanfang, and VIP (up to March 2021) were searched. The randomized controlled trials (RCTs) on dapagliflozin with outcome indicators including malignancy occurrence were collected. Data extraction and quality analysis were performed for the enrolled literature, and meta-analysis was conducted using RevMan 5.3-software. Results A total of 22-studies were enrolled in the analysis, all of which were multicenter RCTs, and the quality evaluation results were all grade A. Thirty-one thousand four hundred and fifty-one patients were involved in the 22-studies, of which 16-267 were in the experimental group (dapagliflozin 5 or 10-mg daily) and 15-184 in the control group (placebo or other hypoglycemic drugs). The course of treatment in the 22-studies ranged from 24 weeks to 5.2 years and it was 24 weeks in 15-studies (68.2%). A total of 1-302 patients developed malignancy during the trials, including 661 in the experimental group and 641 in the control group. The results of the meta-analysis showed that, regardless in the overall study of different dapagliflozin doses or in studies of dapagliflozin 5 or 10-mg/d, the differences in the risk of malignancy between the experimental group and the control group were not statistically significant [overall study: 4.2% (661/15-911) vs. 4.1% (648/15-884), RR=1.02, 95%CI: 0.92-1.13, P=0.72; dapagliflozin 5-mg/d: 0.8% (10/1-181) vs. 0.6% (7/1-172), RR=1.35, 95%CI: 0.57-3.17, P=0.49; dapagliflozin 10-mg/d: 4.4% (651/14-730) vs. 4.4% (641/14-712), RR=1.01, 95%CI: 0.91-1.13, P=0.78]; the differences in the risk of breast cancer were not statistically significant [overall study: 0.2% (25/12-216) vs. 0.2% (25/12-215), RR=1.00, 95%CI: 0.59-1.69, P=1.00; dapagliflozin 5-mg/d: 0.6% (2/348) vs. 0 (0/347), RR=3.00, 95%CI: 0.31-28.65, P=0.34; dapagliflozin 10-mg/d: 0.2% (23/11-868) vs. 0.2% (25/11-868), RR=0.93, 95%CI: 0.54-1.59, P=0.78]; the differences in the risk of bladder cancer were not significantly significant [overall study: 0.1% (16/12-021) vs. 0.2% (28/12-019), RR=0.59, 95%CI: 0.33-1.07), P=0.08; dapagliflozin 5-mg/d: 0.7% (1/137) vs. 0 (0/137), RR=3.00, 95%CI: 0.12-73.00, P=0.50; dapagliflozin 10-mg/d: 0.1% (15/11-884) vs. 0.2 % (28/11-882), RR=0.55, 95%CI: 0.30-1.02, P=0.06]. Conclusion Dapagliflozin may not increase the risk of malignancy in patients with type 2 diabetes mellitus, but its long-term safety needs further study.
  • . 2018, 20(1): 9.
  • Adverse Drug Reactions Journal. 2020, 22(3): 165-169. https://doi.org/10.3760/cma.j.cn114015-20200214-00114
    对于感染2019新型冠状病毒(2019-nCoV)的高血压病患者,是否应该停用血管紧张素转换酶抑制剂/血管紧张素Ⅱ受体阻滞剂(ACEI/ARB)类药物,存在两种相反观点。血管紧张素转换酶2(ACE2)已经被证实是肾素-血管紧张素系统(RAS)负向调控的关键酶,激活ACE2/Ang(1-7)/Mas轴后可以拮抗血管紧张素Ⅱ对RAS激活后的有害作用。ACE2也是SARS病毒和2019-nCoV感染细胞的功能性受体,ACE2在2019-nCoV感染中的作用及对新型冠状病毒肺炎病情的影响,目前尚不明确。目前尚没有ACEI/ARB增加2019-nCoV 感染风险和加重病情的证据。对感染2019-nCoV的高血压病患者不建议停用ACEI/ARB 类药物。
  • Zhu Jianxin, Ma Liping, Zhao Jihong, Shen Sijing
    . 2016, 18(1): 74.
    A 66-year-old male patient with coronary atherosclerotic heart disease received an IV infusion of Shuxuening injection 18 ml+0.9% sodium chloride injection 250 ml once daily after cataract surgery. About 30 minutes after the second infusion start, the patient suddenly experienced chill, whole body pain, nausea and vomiting. His body temperature was 40.2 ℃, heart rate was 110 beats/min, blood pressure was 95/56 mmHg. Laboratory test revealed the following levels: alanine aminotransferase 116 U/L, aspartate aminotransferase 165 U/L, total bilirubin 17.8 μmol/L, direct bilirubin 9.6 μmol/L, urea nitrogen 7.6 mmol/L, and creatinine 110 μmol/L. The patient was diagnosed as anaphylactic shock, liver and kidney injury. Shuxuening injection was stopped. He was treated with intramuscular injection of diphenhydramine 20 mg, IV infusions of dexamethasone 5 mg, IV infusion of glutathione 1.2 g once daily, oral Bailing capsule(百令胶囊) 2 g thrice daily. Two days later, his body temperature was 36.6 ℃, the blood pressure was 124/76 mmHg, and the heart rate was 69 beats/min. The following day, laboratory test showed the following values: alanine aminotransferase 75 U/L, the aspartate aminotransferase 37 U/L, the total bilirubin 8.4 μmol/L, the direct bilirubin 3.0 μmol/L, the urea nitrogen 4.8 mmol/L, and the creatinine 73 μmol/L.
  • 病例报告
    . 2004, 6(1): 48-49.
  • 调查研究
    Li Hong;Zhong Jiming;Zhou Haiyang;Fan Xingzhong
    . 2000, 2(1): 25-27.
    Objective: To give an opinion of using the drug by summarizing adverse reactions of Tripterygium Wilfordii (TW). Methods: Adverse reactions caused by TW were analysed in 82 patients with glomerular diseases. Results: TW may cause headache and dizziness, leukopenia, gonadal toxicity, etc. The patients mostly recovered from adverse reactions by making adjustments in both dose and course of TW and adding relevant treatment. Con- elusion: A reasonable regimen of TW contributes to improving its effects and decreasing its adverse reactions.
  • 论坛
    . 2013, 15(2): 61-3.
  • Wang Yawei, Li Xiaoling, Yan Suying, Wang Yuqin
    . 2016, 18(3): 181.
    ObjectiveTo know the situation of ME in the present and explore the characteristics of ME between the elderly and non-elderly patients in China.MethodsME reports from September 22, 2012 to June 30, 2015 in the Monitoring Network of Medication Safety in China Core Group of International Network for the Rational Use of Drugs (INRUD) were taken. The patients with age  65 years were entered into the elderly patient group and other patients were entered into the non-elderly patient group. The ME category, the persons that triggered ME, ME content, and drugs related to ME in the 2 groups were analyzed and compared.ResultsWithin A total of 8 421 cases of ME were reported and involved 8 421 patients. Of them, 2 503 patients (29.72%) were in the elderly patient group and 5 918 (70.28%) in the non-elderly patient group. The most errors [98.41%(8 287/8 421)] belonged to the second level of ME which did not induce injury to patients. The difference of distribution of ME with different categories between the elderly and non-elderly patient groups were not statistically significant (P>0.05). The errors that triggered by doctors and pharmacists were 5 599 cases (66.49%) and 2 567 cases (30.48%), respectively. The errors that triggered by doctors in the elderly patient group were higher than those in the non-elderly patient group [69.64%(1 743/2 503) vs. 65.16%(3 856/5 918)], the errors that triggered by pharmacists in the elderly patient group was lower than those in the non-elderly patient group [27.21%(681/2 503) vs. 31.87%(1 886/5 918)], and the differences between the 2 groups were statistically significant (all P<0.05). The top 5 errors that triggered by doctors were drug dosage [27.56%(1 543/5 599)], administration frequency [12.40%(694/5 599)], indication [9.09%(509/5 599)], route of administration [8.64%(484/5 599)], and solvent [7.89%(442/5 599)]. The errors about administration frequency, contraindication, and interaction in the elderly patient group were higher than those in the non-elderly patient group (all P<0.05). The top 5 errors that triggered by pharmacists were variety of drugs [51.69%(1 327/2 567)], number of drugs [14.57%(374/2 567)], specification [12.23%(314/2 567)], others [6.31%(162/2 567)], and dosage form [4.25%(109/2 567)]. The errors about number of drugs, administration time, administration frequency, and solvent in the elderly patient group were higher than those in the non-elderly patient group (all P<0.05). There were 6 742 drugs involved in ME, the top 5 drugs were anti-infective agents (1 309 cases, 19.42%), cardiovascular drugs (848 cases, 12.58%), digestive system drugs (649 cases, 9.63%), nervous system drugs (584 cases, 8.66%), and respiratory system drugs (543 cases, 8.05%). The proportions of respiratory system drugs, urinary and reproductive system drugs, allergy and immune system drugs, biological products/vaccines, rheumatoid arthritis and arthritis drugs, and ear/mouth/throat drugs used in the elderly patient group were higher than those in the non-elderly patient group (all P<0.05).Conclusion The most MEs in China belong to the second level which occurred but did not cause injury to the patients, doctors and pharmacists are key personnel that trigger the ME. The doctors or pharmacists that trigger the ME, ME contents, the composition of drugs related to ME are different between the elderly patients and the non-elderly patients. Doctors should pay more attention to frequency of administration, contraindication, and interaction of drugs during prescribing for elderly patients, pharmacists should pay more attention to the number of drugs, administration time, frequency of administration, and solvent during allocating drugs for elderly patients.
  • 1Department of Clinical Pharmacy, Xiaogan Hospital
    Adverse Drug Reactions Journal. 2020, 22(2): 109-110. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.011
    A 53-year-old female patient received an IV infusion of nivolumab 140 mg once daily 20 months after the operation of intrahepatic cholangiocarcinomas. The drug was used on the first and 20th days of the treatment. On day 3 of the second injection of the drug, the patient developed weakness in both lower limbs, which was aggravated on day 14, accompanied by symptoms such as blurred vision, ptosis, chest tightness, short of breath, and palpitation. On day 24 of the second injection of the drug, her condition became worse, the patient raved, then developed no response to voice stimuli. The patient′s consciousness recovered after mechanical ventilation with nasotracheal intubation and symptomatic and supportive treatments. The patient was diagnosed as drug-induced myasthenia gravis crisis combined with heart failure and respiratory failure. After 19 days of treatments with hormone and human immune globulin, her ptosis and palpitation were improved. However, her respiratory failure was not improved. She was unable to breathe sponta- neously.
  • 病例报告
    Zheng Shiming
    . 2008, 10(6): 0-0.
    An 18 yearold woman received general intravenous anesthesia with propofol for induced abortion. The woman received IM atropine 0.5 mg 30 minutes before being transferred to the operating room. Her blood pressure was 116/68 mmHg, her heart rate was 70 beats/min, and her SPO2 was 97% after she was transferred to the operating room. She developed chest distress followed by dysphoria, pallor, dyspnea and extensive urticaria on her chest after a slow IV injection of propofol about 50 mg. Her blood pressure was 50/30 mmHg, her heart rate was 138 beats/min and her SPO2 was 85%. Propofolinduced anaphylactic shock was suspected. Propofol was discontinued immediately. Adrenalin, dexamethasone, promethazine and dopamine were given. Her symptoms improved ten minutes later.
  • 中毒救治
    . 2006, 8(2): 122-123.
  • 监测交流
    . 2005, 7(5): 379-381.
  • 论著
    Lou leiming;Zhu Qiwei;Shi Jun;Yang Xue;Song Kangxing;Zhu Bing;Liu Guoshu;Ye Ping
    . 2006, 8(3): 174-177.
    Objective: To estimate the effect of beta-blocker metoprolol or combination of metoprolol and ACE inhibitor benazapril on glomerular filtration function in mild or moderate hypertensive patients with concealed renal insufficiency (CRI). Methods: Seventy-three hypertensive patients with CRI were divided randomly into two groups,metoprolol (MET) group and metoprolol + benazapril (MET+BEN) group. Patients in the two groups received 6 months therapy with metoprolol 50-75 mg daily or metoprolol 25 mg + benazapril 5-10 mg daily respectively. The target of blood pressure was under 140/90 mm Hg. The serum uric acid (SUA),serum creatinine (SCr) and glomerular filtration rate (GFR) were investigated before therapy and after 6 months of therapy. Results: ①The systolic and diastolic blood pressure level,and control rate were not different between the two groups((131.3±9.9 vs 71.9±10.5,132.0±10.2 vs 68. 9±10.7 mm Hg,78.4% vs 77.8%,P>0.05); ②In MET group,SUA and SCr increased and GFR decreased after 6 months of therapy than those before (from 429±57 to 439±62 mmol/L P<0.05,from 103±14 to 109±17μmol/L P<0.01,from 52.9±5.84 to 49.9± 6.9ml/min·1.73 m2 P<0.01 respectively); ③in MET+BEN group,compared with before therapy,SUA and SCr decreased and GFR increased significantly after therapy (from 426±62 to 417±57 mmol/L,P<0.01;from 105±13 to 98±12μmol/L,P<0.01,from51.3±5.6 to 54.7±6.2 mL/min·1.73 m2,P<0.01 respectivly); ④After 6 months of therapy,SUA and SCr in MET+ BEN group were lower than those in MET group (417±57 vs 439±62 mmol/L,P<0.01; 98±12 vs 109±17μmol/L,P<0.01),GFR higher than that in MET group (54.7± 6.2 vs 49.9± 6.9 ml/min·1.73m2,P<0.01). Conclusion: Metoprolol monotherapy might not be used for treating hypertensive patients with concealed renal insufficiency for its decreasing glomerular filtration functing. But thecombined therapy with metoprolol and ACE inhibitor benazapril might be beneficial to renal function.
  • 安全用药
    . 2004, 6(2): 92-95.
    本文概要介绍了对甲状腺功能和临床检测有较大影响的主要药物,并对其发生率、影响机制和可能的临床干预进行了探讨。旨在加深医药界人士对药物影响甲状腺功能及检测这一临床课题的认识,提高临床合理用药水平,避免或减少误诊误治的发生。
  • Wu Xiaoyan1, Gao Xuesong2, Liu Ruyu3, Guo Jiang4, Cai Haodong3
    Adverse Drug Reactions Journal. 2020, 22(2): 85-94. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.006
    Objective To systematically evaluate the efficacy and safety of tenofovir disoproxil fumarate(TDF) treatment during the second or third trimester of pregnancy for preventing mother-to-infant transmission of hepatitis B virus (HBV). Methods Randomized controlled trials (RCTs) and cohort studies on efficacy and safety of TDF in the second and third trimester of pregnancy for the prevention of mother-to- infant transmission of HBV were collected by searching related databases at home and abroad (up to July 20, 2019). Quality of RCTs and cohort studies were evaluated using bias risk assessment tool of Cochrane collaboration networks and Newcastle-Ottawa Scale, respectively. Meta-analysis was performed using RevMan 5.3 software. The continuous data were expressed using standardized mean difference (SMD) and its 95% confidence interval (CI). The effect values of meta-analysis of dichotomous variables were expressed using odds ratio (OR) and its 95%CI for effectiveness outcome or risk ratio (RR) and 95%CI for safety outcome. Results A total of 12 studies (2 RCTs and 10 cohort studies) were entered, including 1 326 HBV-infected mothers and their 1 281 infants, of which 729 mothers took TDF (the TDF group) and 597 mothers were without intervention or took placebo (the control group) in the second or third trimester of pregnancy. The results of quality evaluation showed that one of the 2 RCTs was at low risk of bias and the other one was at high risk of bias; 9 of the 10 cohort studies were of high quality and one was of medium quality. The meta analysis for effectiveness outcomes showed that the baseline HBV DNA level in patients in the TDF group was significantly higher than that in the control group (SMD=0.15, 95%CI: 0.04-0.26, P=0.008), the prenatal HBV DNA level in patients in the TDF group was significantly lower than that in the control group (SMD=-5.41, 95%CI: -7.26--3.56, P<0.001), the proportion of mothers with HBV DNA undetected before delivery in the TDF group was significantly higher than that in the control group [20.3% (41/202) vs. 2.0% (4/203), OR=27.55, 95%CI: 7.32-103.85, P<0.001], and the HBV infection rate of infants born to mothers in the TDF group was significantly lower than that in the control group [0.8% (5/618) vs. 9.1% (47/516), RR=0.13, 95%CI: 0.07-0.27, P<0.001]. The meta analysis for safety outcomes showed that the differences in the incidence of birth defects, mortality, birth weight, height and head circumference between the TDF group and the control group were not statistically significant (P>0.05 for all), the difference in the incidence of postpartum alanine aminotransferase level rise between the TDF group and the control group was not statistically significant (P>0.05); the results of one study showed that the proportion of mothers with grade 1-2 asymptomatic creatine kinase increase in the TDF group was higher than that in the control group [7.2% (7/97) vs. 0 (0/100), P=0.006] and the differences in the incidence of other adverse pregnancy events and complications in the 2 groups were not statistically significant (P>0.05 for all). Conclusion The treatment of TDF in the second and third trimester of pregnancy can effectively prevent mother-to-infant transmission of HBV and has no significant impact on growth and development of the fetus.
  • 安全用药
    ZENG Han-qing;ZHANG Qiong;PENG Wen-xing
    . 2012, 14(4): 232-5.

    Atorvastatin, a 3-hydroxy-3methylglutaryl-coenzmye A (HMG-CoA) reductase inhibitor, is a lipid-lowering drug with good effects on plasma lipids. Atorvastatin can cause dose-dependent increase in serum aminotransferase accompanied by an enlarged liver, jaundice, an increased direct bilirubin level, and a prolonged prothrombin time. The types of atorvastatin-induced liver injury are cytotoxic, cholestatic, and mixed. The mechanism of atorvastatin-induced cytotoxic liver injury may be related to breakage of hepatocyte chromosome DNA and change in hepatocyte morphology by competitive inhibition of HMG-CoA and ultimately causes hepatocyte apoptosis. The mechanism of atorvastatin-induced cholestatic liver injury may be related to the decreased expression or dysfunction of transporter, which located in sinusoidal membrane of hepatocytes and bile duct membrane, or may be related to the inhibited activity of bile salt and bile acid excretion relative transporter protein. The measures of treatment and prevention for atorvastatin-induced liver injury include: before atorvastatin administration, patients’liver function should be tested and the physician should be aware of patients’medical history, other medications, and alcohol habit; it is suggested that atorvastatin should be started at a small dose; if atorvastatin-induced mild-to-moderate increase in aminotransferase occurs, the dosage should be reduced and the patient might receive liver-protective drug; once severe liver injury appears, the drug should be discontinued immediately and symptomatic treatment should be given.

  • Ma Huanqing, Ma Changxing, Zhang Erfeng, Sun Bo
    Adverse Drug Reactions Journal. 2022, 24(1): 40-42. https://doi.org/10.3760/cma.j.cn114015-20210305-00271
    A 74-year-old male patient was hospitalized for cerebral infarction, hypertension, diabetes mellitus, and coronary atherosclerotic heart disease. During the hospitalization, a thyroid ultrasound examination revealed suspicious nodules. In order to make a definite diagnosis, thyroid ultrasonography was performed, during which 2.4-ml of sulphur hexafluoride microbubbles for injection and 5-ml of 0.9% sodium chloride injection were given intravenously. Ten minutes later, the patient developed fever, confusion, profuse sweating, red skin rash, and blood pressure 80/60-mmHg, and anaphylactic shock caused by sulphur hexafluoride microbubbles for injection was considered. The patient was given intravenous injection of dexamethasone 10-mg, intravenous infusion of adrenaline 1-mg dissolved in 0.9% sodium chloride injection 250-ml, intramuscular injection of promethazine 25-mg, and mask oxygen. About 3-minutes later, the patient′s consciousness gradually turned clear, and the blood pressure rose (103/72-mmHg); 1.5-hours later, the patient′s consciousness was completely recovered, the blood pressure was 143/86-mmHg, the heart rate was 98 beats/min, and the blood oxygen saturation was 0.98. Twenty-four hours later, the rash was basically disappeared, and the patient′s condition was stable.
  • Dai Hongyin, Tuo Mingfu, Chen Hejun, Zhang Yuanyuan, Zhang Yaling, Duo Wenbo
    Adverse Drug Reactions Journal. 2024, 26(8): 460-466. https://doi.org/10.3760/cma.j.cn114015⁃20240226⁃00116
    Objective To explored the clinical characteristics and risk factors of acute kidney injury (AKI) caused by vancomycin combined with piperacillin sodium and tazobactam sodium (VPT) in adult patients with severe infections. Methods Clinical data of adult patients with VPT?related AKI (AKI group) hospitalized at the Affiliated Hospital of Gansu Medical College and People′s Hospital of Hengshui from January 2022 to August 2023 due to severe infections were collected. The occurrence time, severity, and prognosis of AKI in the AKI group were descriptive statistically analyzed. According to the ratio of 1∶1, patients in the control group were randomly selected from those who did not develop AKI after using VPT in the same period. The general information, disease status, baseline laboratory tests results, and the application of VPT and combined drugs, etc. in patients of the 2 groups were collected. The influencing factors of AKI caused by VPT were analyzed by univariate and multivariate logistic regression. Results A total of 1?547 adult patients with severe infections were treated with VPT, of which 175 (11.3%) deve- loped AKI. Among the 175 patients, 81 (46.3%) were male and 94 (53.7%) were female, with an age of (55±22) years; the time from VPT treatment to the occurrence of AKI was (4±1) days, and the severity of AKI was staged as grade 1, 2 and 3 in 97 (55.4%), 54 (30.9%), and 24 (13.7%) patients, respectively. After drug withdrawal, the renal function gradually recovered in 169 (96.6%) of the 175 patients with AKI, and 6 (3.4%) patients needed continuous renal replacement therapy. Multivariate logistic regression analysis showed that the trough concentration of vancomycin >20?mg/L [odds ratio (OR)=2.105, 95% confidence interval (CI): 1.427-3.105, P=0.022], the duration of vancomycin treatment ≥11 days (OR=1.518, 95%CI: 1.232-1.871, P=0.014), the duration of piperacillin sodium and tazobactam sodium treatment ≥14 days (OR=1.826, 95%CI: 1.152-2.894, P=0.029) and longer duration of combined vasoactive drugs (OR=3.315, 95%CI: 1.428-7.695, P=0.005) were independent risk factors for VPT?related AKI. Conclusions VPT? related AKI in adult patients with severe infections mostly occurs within one week of combination therapy, and the severity was mostly stage 1 and 2. The trough concentration of vancomycin >20?mg/L, longer course of VPT treatment, and longer time of combined vasoactive drugs can increase the risk of VPT?related AKI.
  • Sun Huibin, Zhang Zhong, Liu Zheng, Zhang Huizhi
    Adverse Drug Reactions Journal. 2020, 22(1): 32-37. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.01.007
    Objective To explore the effect of dose adjustment based on doxofylline blood concentration monitoring on safety of combination of doxofylline and terbutaline for respiratory diseases.  Methods The subjects were selected from patients who received doxofylline injection, terbutaline sulphate solution for nebulizationor, and the combination of the two drugs and hospitalized in Department of Respiratory Medicine of Zhengzhou Second People′s Hospital from January 1, 2014 to December 31, 2018. Patients who met the inclusion criteria were divided into 3 groups: doxofylline group, terbutaline group, and combination of doxofylline and terbutaline group (combination group). All patients in the 3 groups were given conventional treatments and symptomatic treatments. Doxofylline 300-mg once daily was given by an IV infusion and terbutaline 2-ml (5-mg) thrice daily was given by atomized inhalation for 7-14 days. Adverse reactions in the 3 groups were compared. The dosage of doxofylline in patients with adverse reactions of grade 1 was adjusted to 250-mg once daily, 200-mg once daily for patients with adverse reactions of grade 2, and doxofylline was stopped in patients with adverse reactions of more than grade 3. The blood concentration of doxofylline, the proportion of the patients whose adverse reactions were alleviated or disappeared, the length of hospital stay, and the efficiency of treatment before and after dose adjustment of doxofylline in patients in the doxofylline group and the combination group were compared. Results A total of 6-582 patients were entered in the study. Of them, 1-438 patients were in the doxofylline group, including 793 males and 645 females with age of (61±11) years; 2-217 patients were in the terbutaline group, including 1-281 males and 936 females with age of (60±15) years; 2-927 patients were in the combination group, including 1-644 males and 1-283 females with age of (63±12) years. The differences in gender, age distribution, basic disease, combined disease, and combination medication among the 3 groups were not statistically significant (P>0.05). The overall incidences of adverse reactions in the 3 groups were 13.1% (189/1-438), 8.9% (197/2-217), and 21.2% (620/2-927), respectively, which was higher in the combination group than that in the doxofylline group (χ2=41.271, P<0.001) and the terbutaline group (χ2=142.766,P<0.001) and higher in the doxofylline group than that in the terbutaline group (χ2=16.738,P<0.001). The incidences of tremor and headache in the combination group were higher than those in the other 2 groups(P<0.001), the incidence of hyperglycemia was higher than that in the doxofylline group(P=0.003), the incidence of insomnia was higher than that in the terbutaline group(P<0.001), the incidence of tachycardia was higher than that in the terbutaline group(P<0.001), the incidence of nausea was lower than that in the doxofylline group(P<0.001)and higher than that in the terbutaline group(P<0.001), the incidence of mood disorders was higher than that in terbutaline group (P=0.017). No adverse reactions of more than grade 3 occurred in the 3 groups, the difference in proportions of patients with adverse reactions of grade 1 and grade 2 was not statistically significant(χ2=1.097,P=0.578). The difference in blood concentration of doxofylline in patients with adverse reactions between the combination group and the doxofylline group was not statistically significant before dose adjustment (P>0.05), but all decreased after dose adjustment (all P<0.001) and the blood concentration of doxofylline in the combination group was lower than that in the doxofyllin group [(8.38±2.19) μg/ml) vs. (10.64±2.55) μg/ml, P<0.001]; the proportion of patients whose adverse reactions were alleviated or disappeared in the combination group was higher than that in the doxofylline group [40.81% (253/620) vs. 30.16% (57/189), P=0.008], the hospitalization time was shorter than that in the doxofylline group [(10±2) d vs. (15±3) d, P<0.001], the treatment efficiency was higher than that in the doxofylline group [531 (85.65%) vs. 136 (71.96%), P<0.001]. Conclusion When doxofylline injection is combined with terbutaline solution for nebulizationor, the blood concentration of doxofylline can be controlled at (8.38±2.19) μg/ml by monitoring the blood concentration of doxofylline, which can not only improve the treatment efficacy, but also improve the medication safety.
  • 病例报告
    Qin Li;Liu Miao;Wu Rongrong;Cao Mingxue;Zhu Hong;Xia Hui;Liu Fengqun
    . 2014, 16(3): 180-2.
    A 51-year-old male hepatitis B patient with decompensated liver cirrhosis received IV infusions of somatostatin 3 mg for continuous 12 hours, lansoprazole 30 mg every 12 hours, vitamin K1 10 mg once daily due to upper gastrointestinal hemorrhage. The IV infusions of vitamin K1 and lansoprazole were completed within 2 hours and the patient did not present discomfort symptoms. About 2.5 hours after the IV infusion of somatostatin, the patient developed chills and dyspnea. Somatostatin was withdrawn immediately. About 10 minutes later, he lost consciousness and had no response to voice stimuli. His heart rate was 160 times/min, respiratory rate was 32 breaths/min, and blood pressure undetectable. He was treated with oxygen mask. Intravenous dexamethasone 10 mg, subcutaneous injection of epinephrine 1 mg and intramuscular injection of promethazine 25 mg were given. About 20 minutes later, the patient slowly began to regain consciousness, but still had listlessness and apathy. His symptoms such as chills and dyspnea disappeared 1.5 hours later, and then his heart rate was 110 times/min, respiratory rate was 23 breaths/min, and blood pressure was 109/50 mmHg. His therapy was changed to octreotide acetate 0.5 mg in 0.9% sodium chloride injection 60 ml every 12 hours via IV pump, lansoprazole and vitamin K1 were continued, the similar symptoms did not recur.
  • 病例报告
    . 2006, 8(5): 380-380.
  • 安全用药
    . 2006, 8(3): 191-196.
    多发性硬化是发生在中枢神经系统的一种主要由细胞免疫介导的自身免疫性疾病,同其他大多数自身免疫性疾病一样,目前多发性硬化不能治愈。主要治疗药物包括免疫调节药如干扰素β、卡帕松等;免疫抑制药如糖皮质激素、米托蒽醌、环磷酰胺。本文依据国外最新文献资料,就治疗过程中部分药物的不良反应和处理作一概述。
  • 论著
    Luo Qiang;Tu Mingli;Lei Huaiding;Liu Xianjun;Zhu Shaoming
    . 2005, 7(3): 168-170.
    Objective:To observe the effects and safety of COFETOL cough syrup and budesonide inhalation in treatment of patients with cough variant asthma(CVA). Methods: 72 cases of CVA were dividid into 3 groups: group"COFETOL+budeosonide"(n=30, mean age 35.33±18.56 yrs) receiving the two drugs, group"budesonide"(n=21, mean age 34.88±22.12yrs)receiving budesonide only, and group"prednisone"(n=21, mean age 32.67±19.55 yrs) served as control. The relief time of cough was recorded and the scores of both symptom and bronchial provocative test were added for evaluation of treatment efficiency. The adverse reactions were compared among the three groups. Results: Under the above treatment for 14 days, the effective rates were 90.00%, 90.04% and 90.48% respectively, with no differences in statistics (P> 0.05) between them. The rates of remarkable effects of group "COFETOL+budesonide" were higher than group "budesonide"(60% vs 14.29%, P<0.01),and similar to group "prednisone"(61.90%, P> 0.05). The relief time of cough on average for group "COFETOL+budesonide"(5.9±1.9 days)was obviously shorter than group "budesonide"(9.9±3.2 days, P < 0.01), and no different from group "prednisone"(6.8±2.2days, P > 0.05). Mouth mycosis infection occurred in one case of group"COFETOL+budesonide"(3.33%), hoarse voice did in one case of group "budesonide"(4.76%)and 8 cases with adverse reactions in group "prednisone"(38.09%, P < 0.01). Conclusion: The combination of COFETOL cough syrup and budesonide inhalation is a rapid, secure and new alternative method for treatment of CVA
  • Feng Zhihong, Wei Bing, Teng Guojie, Yu Chunni, Ren Kui, Gao Shang, Nie Xiuhong
    . 2015, 17(3): 196.
    ObjectiveTo evaluate the safety of pirfenidone in treatment of idiopathic pulmonary fibrosis (IPF).MethodsPubMed, the Cochrane library, EMbase, CNKI, and WanFang database were searched using the keywords pirfenidone, idiopathic pulmonary fibrosis, and IPF from January 1999 to January 2015. Randomized controlled trials (RCTs) of pirfenidone in treatment of IPF were selected. The patients in the trial group were given pirfenidone alone while the patients in the control group were given oral placebo. The primary end point event of the outcome was the incidence of pirfenidone′s adverse events. The Meta-analysis was performed using RevMan 5.2.ResultsA total of 4 articles including 5 RCTs were enrolled. There were 945 patients in the trial group and 766 patients in the control group. The incidents of many kinds of adverse events in the trial group were markedly higher than those in the control group, including gastrointestinal discomfort [12.6% (101/804) vs. 5.2% (40/766), RR= 2.31, 95% CI: 1.63-3.29, P< 0.01], nausea [34.6% (241/695) vs. 15.0% (99/659), RR= 2.373, 95% CI:1.92-2.92, P< 0.01] and vomiting [13.3% (83/623) vs. 6.3% (39/624), RR= 2.13, 95% CI:1.48-3.06, P< 0.01], diarrhea [25.8% (161/623) vs. 20.4% (127/624), RR= 1.27, 95% CI: 1.03-1.56, P=0.02], anorexia [15.2% (122/804) vs. 4.7% (36/766), RR= 3.10, 95% CI:2.16-4.46, P<0.01], abnormal liver function [6.0% (49/804) vs. 1.7% (13/766), RR= 2.48, 95% CI: 1.46-4.23, P<0.01], rash [30.4% (189/623) vs. 10.3% (64/624), RR= 2.95, 95% CI: 2.27-3.83, P< 0.01], photosensitivity reaction [24.7% (129/526) vs. 6.1% (30/489), RR= 5.54, 95% CI: 1.78-17.30, P<0.01], insomnia [10.4% (65/623) vs. 6.6% (41/624), RR=1.59, 95% CI: 1.09-2.31, P= 0.02], dizziness [16.4% (120/732) vs. 9.8% (72/731), RR=1.67, 95% CI: 1.27-2.19, P<0.01], fatigue [25.6% (178/695) vs. 16.3% (108/659), RR= 1.60, 95% CI: 1.29-1.98, P< 0.01], and weight loss [10.1% (63/623) vs. 5.4% (34/624), RR= 1.85, 95% CI: 1.24-2.77, P= 0.03]. However, there was no statistically significant difference in treatment-related serious events [26.5% (165/623) vs. 26.4% (165/624), RR= 1.00, 95% CI: 0.83-1.20, P= 0.94]. Compared with the control group, there was a statistical significance in the rate of drug withdrawal in the trial group [14.6% (117/804) vs. 9.0% (69/766), RR= 1.62, 95% CI: 1.22-2.15, P<0.01). ConclusionThe common adverse events of pirfenidone are gastrointestinal, skin, and neurological system damage and fatigue and loss of weight. The adverse events are mild and mostly recoverable without obvious sequelae. The pirfenidone is safe and well-tolerated.
  • 药源性疾病
    LIU Chen;WANG Yu-qin
    . 2012, 14(3): 160-5.
    Drug-induced hypertension is one of the common adverse drug reactions. The mechanism of drug-induced hypertension may involve stimulation of sympathetic nervous system activity, sodium and water retention, renin-angiotensin-aldosterone system activation, and changes in function and structure of arterial elasticity. Clinical presentations are increased blood pressure, rebound phenomenon, and even hypertensive crisis. The risk factors for drug-induced hypertension are advanced age, sex, genetic causes, previous history of hypertension, overweight, susceptibity to sodium, and underlying diseases. The drugs known to cause hypertension should be avoided in high-risk patients; if drug treatment is necessary, the treatment should start with a minimum dosage and blood pressure should be monitored during treatment. Once drug-induced hypertension occurs, the drug should be discontinued immediately or the dosage should be reduced, and symptomatic treatment should be given.
  • 病例报告
    Guo Heng;Cheng Sheng
    . 2010, 12(5): 366-3.
    A 47yearold woman received fluvastatin 40 mg per night after coronary stenting. Meanwhile she was given aspirin, clopidogrel, metoprolol and isosorbide mononitrate. Two months later, the patient presented with asthemia, emaciation, anorexia, and nausea with yellowish skin and dark urine. Biochemical tests showed the following levels: ALT 777 U/L, AST 903 U/L, ALP 367U/L, γ-GT 678U/L, TBil 158.78 μmol/L, DBil 123.86 μmol/L, IBil 34.92 μmol/L, TBA 139.7 μmol/L. Autoantibody tests were positive for antinuclear antibody and antiSSA antibody. Fluvastatin was withdrawn and aspirin, clopidogrel, metoprolol and isosorbide mononitrate were continued. She was treated with compound glycyrrhizin, reduced glutathione, and ursodeoxycholic acid as well. Subsequently, her liver function improved gradually. One month later, biochemical tests revealed the following values: ALT 29 U/L, AST 33 U/L, ALP 122 U/L, γ-GT 150 U/L, TBil 40.04 μmol/L, DBil 26.84 μmol/L, IBil 13.20 μmol/L, TBA 25 μmol/L. Then the patient was discharged. Her liver function normalized on reexamination a month after discharge.
  • WAN Li-yan;ZHANG Ce;GUO Wei-hong;CUI Jian;LI Hong-mei
    . 2013, 15(6): 306-8.
    ObjectiveTo assess the efficacy and safety of sitagliptin in patients with type 2 diabetes mellitus.MethodsPubMed, Embase, the Cochrane Library, and Wanfang Database was searched by using “sitagliptin” as keyword. Randomized controlled trials (RCT), whose endpoints were the level of glycosylated hemoglobin lower than 7% and adverse reactions rates, of sitagliptin in the patients with type 2 diabetes mellitus were collected. The qualities of the RCT which could accord with inclusion criteria were evaluated. The related information was selected and statistically analyzed with RevMan 5.2 software and the odds ratio (OR) and 95% confidence intervals (CI) were calculated.ResultsA total of 25 RCT were entered. Meta-analysis showed the control rate of glycosylated hemoglobin lower than 7% of sitagliptin is better than that of placebo (OR=3.02, 95%CI: 2.48 to 3.67, P=0.00) , worse than that of thiazolidinedione (OR=0.60, 95%CI: 0.41 to 0.88, P=0.01) , and similar to that of merformin (OR=078, 95%CI: 0.51 to 1.19, P=0.25) , glucagon-like peptide (GLP-1) receptor agonists (OR=0.53, 95%CI: 0.15 to 1.92, P=0.34), and sulfonylureas (OR=0.93, 95%CI: 0.58 to 1.48, P=0.76). The adverse reactions rates of sitagliptin was similar with that of placebo (OR=1.11, 95%CI: 0.89 to 1.39, P=0.33) and lower than that of merformin (OR=0.42, 95%CI: 0.32 to 0.55, P=0.00), thiazolidinedione (OR=065, 95%CI: 0.45 to 0.94, P=0.02), GLP-1 receptor agonists (OR=0.45, 95%CI: 024 to 0.83, P=001), and sulfonylureas (OR=0.38, 95%CI: 0.32 to 0.47, P=0.00).ConclusionSitagliptin was effective in lowering the glycosylated hemoglobin level in the patients with type 2 diabetes mellitus and the adverse reaction rate of sitagliptin was lower than those of other antidiabetic drugs.
  • 中毒救治
    Qiu Zewu;Wang Zhe;Peng Xiaobo;Shen wei;Sun Chengwen;Jiang Yanping
    . 2010, 12(2): 114-3.
    Botulinum toxin(BTX) is a neurotoxin produced by Clostridium botulinum. BTX poisoning could cause multiple organ dysfunctions. All 6 patients were women aged 25-55 years. They developed poisoning symptoms 2-9 days after starting injection of BTX. Clinical manifestations included blepharoptosis, dysphagia, blurred vision, barylalia, weakness in the extremities, dyspnea, insomnia accompanied by agitation, and so on. One of them experienced respiratory failure Ⅱ. All the patients received anti-infection, nutritional support, anxiolytic and symptomatic therapy. Meanwhile the patients with severe poisoning received ventilator support and hemoperfusion. All patients recovered and were discharged.
  • 综述
    Yang Wenjun;Xu Xiang
    . 2014, 16(1): 35-4.

    The term of drug-induced thromboembolism refers to intravascular thrombosis and/or thromboembolism due to drugs and resulting in impaired tissue and organ function. The main mechanisms of drug-induced thromboembolism involve injury of endothelial cells, the change of blood components and hemodynamic abnormality. Drugs which cause thrombosis mainly include contrast media, chemotherapeutic agents, immunosuppressive agents, immunopotentiators, cyclooxygenase-2 inhibitors, antipsychotic agents, and hormones. The most common drug-induced thrombosis is deep vein thrombosis such as portal vein, splenic vein, renal vein, or cerebral venous sinus. Arterial thrombosis is less common. Drug-induced thrombosis could be treated with unfractionated heparin, low molecular weight heparin, fondaparinux sodium, warfarin, urokinase, alteplase, argatroban, recombinant hirudin or danaparoid sodium.

  • Wang Fangfang1, Chen Weihong1, He Zhiqiang1, Xu Zheng2
    Adverse Drug Reactions Journal. 2020, 22(2): 69-76. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.004
    Objective To explore the clinical characteristics and risk factors of acute hepatic injury (AHI) due to amiodarone hydrochloride injection. Methods The study was designed as centralized monitoring. The monitored subjects were patients who were hospitalized in Shanxi Bethune Hospital and received amiodarone hydrochloride injection from March 1, 2018 to February 28, 2019, in which the patients with virus hepatitis, autoimmune liver disease, primary carcinoma of liver or hepatic metastasis of malignant tumor, and abnormal liver function before medication were excluded when analyzing the clinical characteristics and risk factors of AHI due to amiodarone hydrochloride injection. The special clinical records of the patients, who developed abnormal liver function after medication and were adjudged as AHI by attending physician and clinical pharmacist, were established by specially-assigned person. The laboratory tests records of the patients treated with the drug were rechecked through the Hospital Information System every month. After finishing the monitoring, the electronic medical records of monitored subjects were collected by searching the Hospital Information System; the patients′ basic information, basic diseases, the total dose of amiodarone hydrochloride injection, combination drugs, the detection results of alanine aminotransferase (ALT),aspartate aminotransferase (AST), and total bilirubin (TBil) before and after application of amiodarone hydrochloride injection, the time from medication to AHI occurrence, and the clinical manifestations, treatment and outcome of AHI were recorded. The patients were divided into the AHI group and the non-AHI group and the clinical features between the 2 groups were compared. The indices of P<0.2 between groups were analyzed using the multivariable logistic regression model, and odds ratio (OR) and its 95% confidence interval (CI) were calculated. Results A total of 271 patients were enrolled into the study. Of them, 34 patients developed AHI, the incidence of AHI was 12.5%. The differences of sex distribution, age, height, body weight, total dose by intravenous medication, situations of other combination drugs (including antiplatelet drugs, statins, Beta-adrenergic blockers, anticoagulants, hormones, and antineoplastic drugs and etc.) between the AHI group and the non-AHI group (237 patients) were not statistically significant (P>0.05 for all). The proportion of patients with coronary atherosclerotic heart disease in the AHI group was higher than that in the no-AHI group [58.8% (20/34) vs. 30.8% (73/237), χ2=10.358, P=0.001]. The differences of ALT, AST and TBil levels between the 2 groups before application of amiodarone hydrochloride injection were not statistically significant (P>0.05 for all). The levels of ALT, AST, and TBil in the AHI group were significantly higher than those in the non-AHI group after application of amiodarone hydrochloride injection [341 (176, 1175) U/L vs. 25 (16, 31) U/L, P=0.014; 439 (167, 1?586) U/L vs. 36 (24, 56) U/L, P=0.029; 36.0 (15.3, 42.1) μmol/L vs.18.6 (14.8, 22.1) μmol/L, P<0.001], and also significantly higher than those in the non-AHI group (P=0.006, P=0.026, P<0.001). Of 34 AHI patients, 19, 14 and 1 patients developed abnormal liver function on day 2, 3 and 5 of medication, respectively, all of them had no obvious clinical signs and symptoms. After being diagnosed as having AHI, 29 patients discontinued the amiodarone hydrochloride injection treatment, 3 changed to lidocaine, and 2 discontinued it after 1 and 3 days of continued medication, respectively. All 34 patients received symptomatic treatments such as liver-protective drugs, in which 32 patients (94.1%) were improved, including 25 patients (78.1%) with liver function within the reference range, 7 patients with ALT and AST levels within 2 times of upper limit of reference range values and their TBil level within the reference range. The other 2 patients (5.9%) developed multi-organ dysfunction syndrome, in which one patient returned with normal liver function after treatment and one died. The results of multivariate regression analysis showed that coronary atherosclerotic heart disease, combined basic diseases ≥3 kinds, and combination drugs ≥3 kinds were the independent risk factors for AHI due to amiodarone hydrochloride injection (OR=3.209, 95%CI: 1.537-6.704, P=0.002; OR=2.437, 95%CI: 1.083-5.486, P=0.031; OR=3.172, 95%CI: 1.507-6.677, P=0.002). Conclusions AHI due to amiodarone hydrochloride injection occurred mostly within 3 days of medication, which are acute onset and no obvious clinical signs and symptoms. The AHI′s diagnosis is mainly based on liver function examination. Patients with coronary atherosclerotic heart disease, combined basic diseases ≥3 kinds, and combination drugs ≥3 kinds are independent risk factors for AHI due to amiodarone hydrochloride injection.
  • 药物评介
    . 2005, 7(2): 116-117.
  • 论著
    Wang Lina①;Liu Fang②;Wu Yubo①;Li Shuang②
    . 2006, 8(5): 336-338.
    Objective: To study the effect of Shuxuetong injection on cell apoptosis of rats with cerebral ischemia. Methods: Seventy-two male Wistar rats were randomly divided into three groups: cerebral ischemia group, treatment group, and control group. Each group had 24 rats. Cerebral ischemia model was performed by embolisming middle cerebral artery. The rats of treatment group were injected with Shuxuetong 0.2 ml/kg. The rats of cerebral ischemia group and control group were injected with physiological saline. The nerve cell apoptosis of cerebral tissue was detected by TUNEL test mediated with deoxynucleotidyl transferase terminal. Results: The number of TUNEL positive cells was significant increased with the time prolonging in cerebral ischemia group and obviously decreased in treatment group (P< 0.01). Conclusion: Shuxuetong injection can obviously inhibit the nerve cell apoptosis of rats with cerebral ischemia.
  • 药源性疾病
    Wu Liyong;Jia Jianping
    . 2008, 10(4): 0-0.
    Sleepwalking is a sleep disorder characterized by walking or other unusual behaviors or activities during sleep, and it usually occurs during the slowwave stages of non-rapid eye movement sleep. Sleepwalking caused by drugs is called druginduced sleepwalking. The common drugs causing sleepwalking were sedative hypnotics, antipsychotic drug, antidepressant, and so on. It is said that the development of druginduced sleepwalking may need a combination of factors: a history of sleepwalking, a drug increasing slowwave sleep, and a external and internal stimulus. The mechanism of druginduced sleepwalking is not well understood. A hypothesis is proposed that some neurotransmitter such as serotonin and gammaaminobutyric acid can increase slowwave sleep, leading sleepwalk. The principle of treatment for druginduced sleepwalking includes decrease in dosage or cessation of causative drugs, removal of risk factors, making safe environment, and administration with benzodiazepines.
  • Liu Yanhui, Ruan Wenyi, Chen Huiying, Mei Kangkang, Cai Heping
    Adverse Drug Reactions Journal. 2023, 25(8): 469-474. https://doi.org/10.3760/cma.j.cn114015-20230227-00121
    Objective To explore the risk signals of montelukast-related adverse events (AEs) in pediatric patients and provide reference for the safe use. Methods AE reports of children with montelukast as the primary suspect drug from the first quarter of 2004 to the third quarter of 2022 were collected by searching the US FDA Adverse Event Reporting System database (FAERS). AEs were standardized and classified according to the preferred terms (PT) and system organ class (SOC) of Medical Dictionary for Regulatory Activities 23.0. Proportional reporting odds ratio (PRR) method was used to mine the AE risk signals of montelukast. An AE with reports ≥3, PRR≥2, and χ2>4 was defined as a positive signal, which were analyzed using descriptive method. Results A total of 5-179 AE reports were included in the analysis, involving 1-295 PTs, and 233 positive PTs were obtained by PRR method. The top 10 PTs in AE reports were aggres- sive behavior, anxiety, suicidal ideation, abnormal behavior, depression, anger, nightmares, insomnia, crying loudly and night terrors. Except crying loudly, all of them were adverse reactions recorded in the label. The top 10 PTs in signal intensity were sensory overload, arrhythmia, separation anxiety disorder, loneliness phobia, dust allergy, Mille-Fisher syndrome, eosinophilic granuloma complicated with polyangitis, personality disorder in children, night terrors and decreased platelet adhesion. Among them, abnormal heart rate, Mille-Fisher syndrome and decreased platelet adhesion were not recorded in the label. A total of 59 of the 233 positive PTs were not recorded in the label, involving 10 SOCs. The top 5 SOCs were social environment, mental illness, injury, poisoning and surgical complications, general conditions and administration site, and respiratory, thoracic and mediastinal diseases. Conclusion The main AEs of pediatric patients receiving montelukast treatment in the US FAERS are aggressive behavior, anxiety, depression, insomnia, night terrors, etc., all of which are adverse reactions recorded in the label; adverse reactions not recorded in the drug label include abnormal heart rate, Miller-Fisher syndrome, and decreased platelet adhesion.
  • Wang Qian, Liu Chen, Duan Fangfang, Chang Chunyan, Zhai Hang, Yang Song
    Adverse Drug Reactions Journal. 2021, 23(9): 487-490. https://doi.org/10.3760/cma.j.cn114015-20210429-00514
    A 29-year-old male hepatitis C antibody-positive patient did not receive systematic treatment because there was no obvious symptoms and his liver function was normal. Later, the patient was diagnosed with diffuse large B-cell lymphoma (DLBCL) stage Ⅳ and received immunochemotherapy. The drugs included rituximab, etoposide, cyclophosphamide, epirubicin, vincristine, and methylprednisolone. Immunochemotherapy had the risk of inducing hepatitis C activity and causing liver injury, so it is necessary to explore the right timing and agents of direct acting antivirals (DAAs) for hepatitis C virus (HCV). Then we built a special research team. By reviewing the relevant guidelines and literature, querying the drug interaction website of Liverpool University, and consulting relevant experts, it was decided to treat HCV while immunochemotherapy with sofosbuvir/ledipasvir regimen, which had the least risk of drug-drug interactions (DDIs) with his immunochemotherapy agents. After 12 weeks of treatment, hepatitis C was cured in the patient and there was no obvious DDIs and serious hepatotoxic events.
  • 中毒救治
    Huang Guang;Tang Yu;Wang Junfang;Du Tieying
    . 2009, 11(2): 111-3.
    Shandougen is dried root and rhizome of Sophora tonkinensis Gapnep, which contains matrine and oxymatrine, and so on. Shandougen has antiinflammatory, antipyretic, antibacterial and antiviral effects, and its common dosage is 3~6 g daily. The dosage >10 g may cause toxication. The main symptoms of toxication include nausea, vomiting, abdominal pain, diarrhea, tremor of extremities, convulsion, coma, tachycardia, respiratory depression, decreased blood pressure. Death may result from respiratory failure and pulmonary edema. This paper reports globus pallidus lesion and generalized torsion dystonia due to Shandougen poisoning in two patients. Patient 1, a 12yearold boy, received from Shandougen 20 g/day which was prepared to a decoction and was divided into three equal doses for hepatitis. Patient 2, a 4yearold boy, received from Shandougen 5 g/day which was prepared to a decoction for a cold. Later, both patients developed globus pallidus lesion and generalized torsion dystonia. Shandougen was discontinued and oral clonazepam was given, then their symptoms were markedly relieved.
  • 病例报告
    . 2006, 8(6): 448-449.
  • 中毒救治
    Cui Jing;Wang Jingwen
    . 2009, 11(1): 37-3.
    A 26yearold woman ingested 70 colchicine 0.5 mg tablets or more in a suicide attempt. Three hours later, she developed nausea, vomiting, abdominal pain, and diarrhea. Ten hours later, she was given an emetic and gastric lavage. After 3 days, she presented with a fever of 39℃, muscular pain, and abdominal pain. Laboratory values include: WBC 0.7×109/L, PLT 7×109/L, ALT 94 U/L, AST 398 U/L, ALB 25 g/L, CK 4 723 U/L, CK-MB 169 U/L, LDH >1 000 U/L,α-HBDH 1 837 U/L, BUN 4.09 mmol/L, SCr 76 μmol/L, potassium 2.66 mmol/L, calcium 1.6 mmol/L, phosphate 0.14 mmol/L, serum myoglobin 217 μg/L. The woman was diagosed with colchicine poisoning. Multiorgan system failure occurred. Filgrastin, platelet transfusion, correction of electrolyte, IV fluid, and other symptomatic therapy were given. After 21 days of treatment, her body temperature and laboratory values retured to normal except paralysis of bladder sphincter and periperal paresthesia and she was discharged.
  • 调查研究
    Dong Shenga;Qi Xiaolianb;Hu Yongshenga
    . 2008, 10(6): 0-0.
    Objective: To analyse the effects of oral sodium valproate on plasma fibrinogen levels. Methods: Clinical data from the patients with decreased plasma fibrinogen levels in our hospital from March 2007 to January 2008 were collected. The patients’sex and age, dosage and administration of sodium valporate, treatment duration, time period after drug withdrawal, changes in fibrinogen levels before and after drug withdrawal, and outcome were investigated retrospectively. Results: Of the 7 patients [6 males and 1 female aged 15~43 years, average age (23.43±9.24) years], four received sustainedrelease sodium valporate tablets and three received sodium valporate tablets. The dosage was 0.1~0.6 g two to three times daily. Treatment duration was (8.9±8.8) months. The time period after drug withdrawal was (6.14±3.80) d. Fibrinogen levels before and after drug withdrawal were (1.56±0.45)g/L and (3.98±2.23)g/L, respectively. The difference was stastistically significant (P<0.05). After stopping sodium valproate and receiving symptomatic therapy, six patients’fibrinogen levels increased to 2.0 g/L, One patient’s fibrinogen level increased from 1.58 g/L to 1.71 g/L 6 days after drug withdrawal. Conclusion: Sodium valproate can decrease plasma fibrinogen levels of patients. Fibrinogen levels should be monitored during sodium valproate therapy for preventing severe bleeding.
  • 综述
    . 2006, 8(4): 241-244.
    静脉滴注免疫球蛋白用于多种自身免疫性疾病和炎症性疾病的治疗,其作用机制包括对自身抗体的作用,抑制补体结合,阻止膜攻击复合物形成,调节巨噬细胞Fc受体,抑制致病性细胞因子和其他免疫调节分子等。该药不反应反应较少,主要有皮肤过敏反应、无菌性脑膜炎、血浆黏度增加和血栓形成以及肾功能损害等。
  • 调查研究
    Zhang Yuqiu①;Huang Xiang②
    . 2003, 5(5): 308-311.
    Objective:To review adverse reactions related to interferon.Method:Literature survey was based on national medical journals of1993-2002for analysis.Re sults:153adverse reactions of99cases taking interferon were reported.In the initial stage of therapy the commonest reactions were flu-like symptoms.After administration repeatedly,many organs/systems were involved.Con clusion:The adverse reactions of interferon are usually mild and re versible,rarely severe and fatal.Care should be taken in order to prevent and reduce the occurrence of unwanted reac tions.
  • 病例报告
    . 2001, 3(1): 40-40.
  • Su Yanxu, Luo Xiu
    . 2016, 18(6): 461.
    A 66-year-old man received an adjuvant chemotherapy with gemcitabine (1.8 g intravenous infusion, d1 and d8, 21-day as a cycle) and cisplatin (100 mg intraperitoneal perfusion, 1 time/week) for recurrence of postoperative cholangiocarcinoma. On day 11 after the second IV infusion of gemcitabine, the patient′s platelet count was 537×109/L. Six days later, the platelet count increased to 1 191×109/L. Secondary thrombocytosis was considered. Oral aspirin 100 mg once daily and subcutaneous injection of low molecular weight heparin calcium 5 000 U twice daily were given. Five days later, the platelet count was 838×109/L, oral hydroxyurea 0.5 g thrice daily was given. Seven days later, the platelet count was 232×109/L.
  • 监测简报
    . 2004, 6(1): 53-54.
  • 病例报告
    Lou Qiaozhen
    . 2010, 12(5): 359-2.

    A 43yearold female patient with respiratory infection was given an IV infusion of cefoperazone sodium/sulbactam sodium ( dosage not stated ) . Several minutes later, the patient suddenly developed chest tightness and nausea, followed by a coma. Cefoperazone sodium/sulbactam sodium was discontinued immediately and dexamethasone, promethazine, and adrenalin were given. Her condition continued to worsen and respiratory and cardiac arrest appeared. Her heart beat was restored normal after cardiopulmonary resuscitation but she was absence of spontaneous respiration. Her pulse rate was 147 beats/min and blood pressure was undetectable. She presented with lip cyanosis, generalised severe edema, massive ecchymoses, and anuria during the disease course. Laboratory tests revealed the following values: SCr 214 μmol/L, BUN 8.3 mmol/L, K+ 2.9 mmol/L, pH 6.67, and BE -14. The patient finally died from cardiac failure despite resuscitation attempts for 44 hours.

  • 病例报告
    Zhao Haiqin;Han Wenmei
    . 2010, 12(3): 213-2.
    Two men with chronic hepatitis, aged 40 and 72 years, were treated with adefovir dipivoxil 10 mg once daily for abnormal liver function. They experienced renal damage in the third and second years, respectively. The patient 1 had a SCr level of 166 μmol/L and a serum phosphorus level of 0.69 mmol/L; the patient 2 had a SCr level of 124 μmol/L, a serum phosphorus level of 0.61 mmol/L, and a 2+ urine protein. Adefovir dipivoxil was reduced to 10 mg once every other day, and then their biochemical indices normalized gradually. Later, the patient 2 voluntarily increased adefovir dipivoxil dosage to 10 mg once daily for elevated HBV DNA level. One month later, his SCr level was 119 μmol/L. Subsequently, his renal function returned to within normal range after his dosage reduction again.
  • 病例报告
    Xing Yan;Lu Shan;Tang Ya'nan;Zhou Wei
    . 2008, 10(6): 0-0.

    A 1year and 9monthold girl with Kawasaki disease took dipyridamole 25 mg for treatment of thrombocytosis (684×109/L). About 15 minutes after taking the first dose, the girl developed vomiting, drenching sweats, pallor, perioral cyanosis, swelling of her lips, and dyspnea. She had a temperature of 36.3℃, a HR of 130 beats/min, a respiration rate of 32 breaths/min, and a BP of 97/54 mmHg. Dipyridamoleinduced anaphylaxis was diagnosed. Intramuscular adrenalin was administered immediately. Her symptoms resolved 5 minutes later. Cetirizine and methylprednisolone were given 30 minutes later. She recovered completely one hour later.

  • 综述
    . 2003, 5(3): 151-155.
    本文重点介绍了细菌耐药性的特点与发展,细菌耐药机制,以及有关临床干预。旨在加深对细菌耐药性问题的了解和重视,提高临床合理用药水平,避免或减少细菌耐药性的发生。
  • 综述
    DingLi①;ChengGang②
    . 2007, 9(3): 153-157.
    Sorafenib, an oral multikinase inhibitor, is a novel multi-targeted antineoplastic agent that can inhibit angiogenesis and tumor cell proliferation. Clinical studies have showed that sorafenib is effective in treatment of patients with advanced renal cell carcinoma and in prolongation of progression-free survival (PFS) and overall survival (OS) of the patients. The effects of sorafenib on some other cancers are also under investigations. The common adverse reactions to sorafenib are rash, hand-foot syndrome, hypertension, diarrhea, and so on.
  • Tian Xiaojiang, Wang Xiaoli, Wang Kejing, Chen Lin
    Adverse Drug Reactions Journal. 2020, 22(7): 398-403. https://doi.org/10.3760/cma.j.cn114015-20190726-00612
    Objective To systematically understand the occurrence of dabigatran etexilate-related bleeding events, and provide reference for clinical safe drug use. Methods Reports on adverse event (AE) and bleeding event, in which dabigatran etexilate was considered as the first suspected drug, in the US Food and Drug Administration Adverse Event Reporting System (FAERS) from January 2004 to April 2019 were extracted. According to the preferred system organ class (SOC) and preferred term (PT) from terminology of adverse drug reactions in Medical Dictionary for Regulatory Activities, the bleeding event reports were classified, and the patient′s age, gender, drug dosage and AE occurrence were extracted. Based on SOC and PT respectively, the signals of dabigatran etexilate-related hemorrhage were detected using 3 methods inclu- ding reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN). If the results were all positive using the 3 methods, it would be considered as the suspected AE signal. Results A total of 56-501 AE reports with dabigatran etexilate as the primary suspected drug were collected, in which 19-737 (34.93%) reports were about bleeding events. Among the 19-737 patients, 9-687 (49.08%) were male, 9-790 (49.60%) were female, and 260 (1.32%) were with unknown gender; their ages ranged from 18 to 95 years, 2 742 (13.89%) patients were <75 years old, 15-051 (76.26%) were ≥75 years old, and 1-944 (9.85%) were with unknown age; the dose of dabigatran etexilate was 110-mg once daily in 416 patients (2.11%), 110-mg twice daily in 2 346 patients (11.89%), 150-mg once daily in 525 patients (2.66%), 150-mg twice daily in 402 patients (20.33%), and unknown in 12-438 patients (63.02%); 9-242 patients (46.83%) developed serious bleeding events, and 3-260 patients (16.52%) died. The SOCs with positive signals detected using the 3 methods were gastrointestinal disorders(14-382 cases,72.87%), central nervous disorders (3-216 cases,16.29%), renal and urinary disorders (7.41%, 1-462 cases), skin and subcutaneous tissue disorders (2.92%, 576 cases), and eye disorders (0.51%, 101 cases). The top 3 SOCs with higher signal intensities were gastrointestinal disorders, renal and urinary disorders, and central nervous disorders. A total of 32 PTs with positive signals were detected using the 3 methods. Of them, 12 PTs were positive in gastrointestinal disorders, and the top 5 PTs with higher signal intensities were lower gastrointestinal bleeding, gastrointestinal bleeding, upper gastrointestinal bleeding, chronic gastrointestinal bleeding, and melena; 2 PTs were positive in renal and urinary disorders, in which the urinary tract hemorrhage was with higher intensity; 11 PTs were positive in central nervous disorders, and the top 5 PTs with higher signal intensities were intracranial hemorrhage, intracranial hematoma, hemorrhagic stroke, subdural hemorrhage, and epidural hemorrhage; 4 PTs were positive in skin and subcutaneous tissue disorders, and the signal intensity of subcutaneous hemorrhage ranked the first; 2 PTs were positive in eye disorders, in which the conjunctival hemorrhage was with higher intensity. Conclusions Bleeding is more severe in dabigatran etexilate-related AEs, and gastrointestinal bleeding is more common. Patients with age ≥75 years have a higher risk of bleeding, which should be paid attention to in clinic.
  • Xu Yichun, Liu Chen, Shen Jianghua, Zhang Lan, Chu Yanqi
    Adverse Drug Reactions Journal. 2022, 24(3): 139-143. https://doi.org/10.3760/cma.j.cn114015-20210909-00976
    Contrast induced acute kidney injury (CI-AKI) is a serious complication after contrast- enhanced CT scanning. Since the incidence of CI-AKI after contrast-enhanced CT scanning is very low, it is particularly important to screen the high-risk population of CI-AKI for targeted prevention using the risk assessment model. In this paper, 6 risk prediction models for CI-AKI after contrast-enhanced CT scanning are retrieved by searching the literature at home and abroad, including Herts′ prediction equation, Kim′s nomogram prediction model, Huang′s scoring prediction model, Moos′s risk factor prediction model, Jeon′s risk scoring prediction model, and Baek′s risk scoring model for CI-AKI prognosis in patients with chronic kidney disease. The predictive factors involved in the 6 models include estimated glomerular filtration rate, serum creatinine, and serum albumin before contrast-enhanced CT scanning, patient′s age, history of diabetes mellitus, hypertension, and chronic kidney disease, development of acute hypotension or congestive heart failure, and repeated use of contrast. Baek′s risk scoring model is used to predict the development and outcome of CI-AKI in patients with chronic kidney disease after contrast-enhanced CT scanning, while the other 5 models are prediction models for the risk of CI-AKI after contrast-enhanced CT scanning. However, the performance indicators of these 6 models are incomplete and lack of external verification by other researchers.
  • Zhang Jingyue, Yang Chong, Lan Gaoshuang, Sun Yinjuan, Zhang Linlin, Yuan Hengjie
    Adverse Drug Reactions Journal. 2023, 25(10): 577-583. https://doi.org/10.3760/cma.j.cn114015-20230420-00291
    Objective To provide a basis for the selection of antiemetic regimen by establishing an artificial intelligence model for predicting chemotherapy-induced nausea and vomiting (CINV) in cancer patients receiving platinum-based chemotherapy with high emetic risk. Methods The clinical information on cancer patients who received cisplatin or carboplatin with area under the blood concentration-time curve (AUC) ≥4 and registered in the Department of Oncology, Tianjin Medical University General Hospital from January 2018 to December 2022 was collected, including gender, age, history of alcohol consumption, history of vomiting in pregnancy, chemotherapy cycle, patient expects to have CINV, chemotherapeutic agents, antiemetic regimen, out-of-hospital antiemetic treatment, sleep of less than 7 hours on the night before chemotherapy, occurrence of CINV in the previous cycle, and creatinine clearance (Ccr). After pre-proces- sing, the data were randomly divided into the training set and the test set. The training set was used to construct the prediction model, and the test set was used to evaluate the prediction efficiency of the model. Three algorithms, gradient boosting decision tree (GBDT), random forest (RF), and logistic regression (LR), were used to build a prediction model and evaluate the model performance, respectively. The evaluation metrics included accuracy, sensitivity, recall, F1 value (the reconciled mean of sensitivity and recall), and area under the receiver operating characteristic curve (AUROC). Finally, Shapley Additive exPlanation (SHAP) was applied to analyze the interpretability of the clinical features with predictive significance. Results A total of 698 patients, 439 males (62.9%) with a median age of 64 (21, 84) years, were included in this study and received a total of 1-654 cycles of chemotherapy. The chemotherapy regimen contained cisplatin in 364 cases with 864 cycles of chemotherapy, and carboplatin with AUC ≥4 in 361 cases with 790 cycles of chemotherapy. The number of treatment cycles in which neurokinin-1 receptor antagonist (NK-1 RA), 5-hydroxytryptamine-3 receptor antagonist (5-HT3 RA), and dexamethasone were selected as the antiemetic regimen was 1 347, and in those with the selection of 5-HT3 RA and dexamethasone was 307. The Spearman′s correlation analysis showed no strong correlation between the feature variables in the patients, and all of them could be used for model building. GBDT optimal hyperparameters n_estimators=500, max_depth=9; RF optimal hyperparameters max_depth=5; LR optimal hyperparameters penalty=L2. Three prediction models, GBDT, RF and LR, were established based on the optimal hyperparameter training data, respectively. The accuracy of GBDT model was 0.903, sensitivity was 0.882, recall was 0.903, F1 value was 0.883, and AUROC was 0.778±0.036 (95%CI: 0.739-0.814); the accuracy of RF model was 0.885, sensitivity was 0.861, recall was 0.885, F1 value was 0.870, and AUROC was 0.679±0.041 (95%CI: 0.636- 0.720); the LR model had an accuracy of 0.817, a sensitivity of 0.851, a recall of 0.817, an F1 value of 0.832, and an AUROC of 0.682±0.042 (95%CI: 0.639-0.723). Ccr, age, chemotherapy cycle, history of alcohol consumption, and patient expects to have CINV were the main features predicted by the model. The risk of CINV was negatively associated with Ccr, age, and chemotherapy cycle. And the risk of CINV was lower in patients with no history of drinking alcohol and patient expects to have CINV. Conclusion The GBDT, RF, and LR models could all predict the risk of CINV in patients receiving platinum-based chemotherapy with high emetic risk, with the GBDT model having the best predictive effect.
  • 安全合理用药
    Sun Fengxia
    . 2007, 9(6): 400-403.
    Nimesulide is a non-steroidal anti-inflammatory drug,and is a selective inhibitor of cyclooxygenase type 2(cox-2).It is well tolerated,and has a relatively low occurrence of adverse drug reactions especially in the gastrointestinal tract.Recently,in some countries nimesulide has been withdrawn from the market because of nimesulide-induced severe liver injury and death.However,finalising a review of liver safety of nimesulide the European Medicines Agency(EMEA) has concluded that the benefits of the drug still outweigh its risks,but that there is need to restrict its use.The pathogenic mechanisms of nimesulide-induced liver injury are unclear,possibly associated with the immunologic and metabolic idiosyncratic reactions.The precautions against nimesulide-induced liver injury include administering nimesulide only in a good indication;limiting the drug to a maximum duration of 15 days;avoiding high dosage and drug combinations;administering the medication with cautions in the elder and wo men;avoiding use in children;monitoring liver function in case the duration of nimesulide use is more than 1 week.
  • 病例报道
    . 1999, 1(2): 117-117.
  • 学术讨论
    . 2000, 2(3): 182-186.
    本文列举临床现有的不合理用药表现,大致划定了临床不合理用药的范围,并从人员因素、药物因素和外界因素几方面剖析了导致不合理用药的原因,揭示了不合理用药造成的医学、经济学和社会学后果,为进一步探索和制定促进合理用药的对策提供了基础。
  • 调查研究
    Yan Yuanyuan;Zhang Zhiping;Zhou Xiaoqing;et a.
    . 2000, 2(2): 98-102.
    Objective: To review PN-caused adverse reactions, complications, clinical manifestation and patho-genesis. Methods: 2947 entries (1995-1998) from the data bank of all-army ADR monitoring center were analysed together with the references retrieved. Results: 59 cases of PN-ADR accounted for 2% . Major complications of PN were enterogenous infection and cholestasis. Conclusion: PN support therapy needs balance of its efficacy, side effect and cost so as to use it rationally.
  • 病例报告
    . 2004, 6(3): 207-207.
  • 监测交流
    . 2006, 8(1): 56-59.
  • 论著
    Wang Hong;Huang Ying;Zhang Shuwen;Ren Aimin;Zhang Lixia;Wang Bao'en
    . 2007, 9(4): 247-250.
    Objective:To analyze the etiology and clinical characteristics of pneumonia secondary to immunosuppressant regimens in renal transplant patients.Methods:The clinical data of 51 renal transplant patients with pneumonia receiving immunosuppressant regimens from four hospitals in Beijing between January 1999 and December 2004 were collected.The renal transplant patients were administered orally with cyclosporine 90~400 mg daily,mycophenolate mofetil 500~1 500 mg daily,and prednisone 5~30 mg daily for 3 months,and then the dosage was decreased to maintenance dose(Blood cyclosporine concentration was maintained in 100~200 ng/ml).The etiology,clinical manifestations,incidence of organs dysfunction and death to the renal transplant patients accompanied with pneumonia were analyzed.Results:The principal clinical characteristics of the 15 patients were interstitial pneumonia.The clinical manifestations were fever and cough.A chest X-ray revealed a blurred shadow.Of 51 cases,17 cases(33.33%)were bacterial infections,7 cases(13.73%)were virus infections,4 cases(7.84%)were pulmonary carinii infection,1 case(1.96%)was fungal infections,8 cases(15.69%)were unknown and 14 cases(27.45%)were mixed infections.Bacterial culture revealed Gram negative bacteria constituted the majority.Of total bacterial strain count,Gram negative bacteria accounted for 60% and Gram positive bacteria accounted for 40%.Adult respiratory distress syndrome and disseminated intravascular coagulation occurred in 11 cases(21.57%)and 4 cases(7.84%),respectively.Of all patients,11 cases(21.57%)died,and 40 cases(78.43%)were cured.Conclusion:Pneumonia is a severe complication in renal transplant patients receiving immunosuppressant regimens.Early diagnosis,anti-infective therapy,and adjustment of immunosuppressant regimens benefit to decrease the occurrence of pneumonia and to increase the cure rate.
  • Hu Xinling, Zhang Wen, Sha Dan, Yang Xiaolin
    . 2016, 18(4): 297.
    A 23-year-old male patient was given the chemotherapy regimen consisting of IV infusion of oxaliplatin (225 mg, the first day) and oral capecitabine (1.5 g in the morning, 2.0 g in the evening, the first day to the 14th day) after resection of colon cancer. The chemotherapy cycle was 21 days. Six hours after the first infusion of oxaliplatin, the patient began to have blurred vision, upper quadrant visual field defect and amaurosis when sitting. The symptoms occurred as intermittent episodes 5-6 times, about 10 seconds each time. On day 2, eye examination showed no abnormality, and he had a clear vision than the day before. On day 3, the visual field returned to normal. The chemotherapy regimen of the second cycle was changed to single drug capecitabine. Abnormal visual field did not recur.
  • Zhang Menghua, Chen Zhiyao, Liu Xiaoxue, Shan Zhili, Yang Gang, Zhou Qiyang, Zhou Yudi, Zhou Xiaojun, Miao Liyan
    Adverse Drug Reactions Journal. 2021, 23(10): 517-522. https://doi.org/10.3760/cma.j.cn114015-20210413-00446
    Objective To explore the value and threshold of steady-state trough plasma concentration (trough concentration) of imatinib mesylate (IM) and its active metabolite N-desmethyl imatinib (NDI) in predicting the risk of moderate to severe adverse reactions in patients with gastrointestinal stromal tumors (GIST). Methods The subjects were selected from GIST outpatient who received IM treatment and re-visited doctor in the First Affiliated Hospital of Soochow University form July 2020 to March 2021. On the day of re-visiting, the relevant clinical information and occurrence of IM-related adverse reactions within 28 d prior to the trial of selected patients was asked and recorded and blood were collected (22 to 24-hours after the last medication) to determine IM and NDI trough concentration. Twenty-eight days after blood collection, telephone follow-up was conducted to record IM-related adverse reactions occurrence. Blood routine and blood biochemical examination results within 28 days before and after blood collection were collected through the hospital information system. After evaluating causality for adverse reactions and grading their severity, patients without or with grade I adverse reactions were regarded as the no/mild group and those with grade Ⅱ~Ⅴadverse reactions were regarded as the moderate-severe group. The risk factors of moderate-severe adverse reactions were analyzed by comparing the main clinical characteristics of patients in the 2 groups, and the value and threshold of IM and NDI trough concentrations in predicting the risk of moderate-severe adverse reactions were analyzed by receiver operating characteristic (ROC) curve. Results A total of 119 patients were recruited in this study and 113 (95.0%) had adverse reactions. There were 65 patients in the no/mild group and 54 in the moderate-severe group. The differences in the gender and dose distribution of patients in the 2 groups were statistically significant (χ2=19.772, P<0.001; χ2=9.817, P=0.020); proportions of females, patients at dose of 300-mg/d, and patients at dose of 600-mg/d in the moderate-severe group were greater than those in the no/mild group. The trough concentration of IM and NDI of patients in the moderate- severe group were significantly higher than those of patients in the no/mild group[1-695 (1-258, 2-261) μg/L vs. 1-360 (938, 1-643) μg/L, P<0.001; 324(223, 379) μg/L vs. 264(217, 338) μg/L, P=0.042]. ROC curve analysis results showed that the breakpoints of IM and NDI trough concentrations for moderate-severe adverse reactions in patients with GIST were 1-539-μg/L (sensitivity 62.3%, specificity 70.3%) and 303-μg/L (sensitivity 56.6%, specificity 68.7%) respectively. The 119 patients were grouped according to the breakpoint concentrations. The incidences of moderate-severe adverse reactions were 63.0% (34/54) and 30.8% (20/65) in patients with IM trough concentration >1-539-μg/L and ≤1-539-μg/L, respectively and 59.6% (31/52) and 34.3% (23/67) in patients with NDI trough concentration >303-μg/L and ≤303-μg/L, respectively. The differences were statistically significant (P<0.001, P=0.006). Conclusions The trough concentrations of IM and NDI are of some value in predicting the risk of moderate-severe adverse reactions in patients with GIST. Drug monitoring should be strengthened in patients with IM trough concentration >1-539-μg/L and NDI trough concentration >303-μg/L to ensure the safety of IM use.
  • Zheng Yuan, Yan Chen, Li Bin, Li Zhengxiang, Yuan Hengjie
    Adverse Drug Reactions Journal. 2024, 26(9): 524-529. https://doi.org/10.3760/cma.j.cn114015‑20231108‑00783
    Objective To mine the adverse events (AE) of nervous system caused by epidermal growth factor receptor (EGFR) inhibitors, and provide reference for the safe use of EGFR inhibitors in clinics. Methods AE of nervous system caused by gefitinib, erlotinib, afatinib and osimertinib were searched from FDA Adverse Drug Event Reporting System (FAERS) database using OpenVigil data platform from 2004, 2004, 2013, and 2015 to the 2nd quarter of 2023, respectively. The AE was standardized using the preferred term (PT) in the Medical Dictionary for Regulatory Activities 23.0 version. Data such as patient general condition and AE of nervous system was extracted from AE reports and was analyzed descriptively. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used for detection of AE signal of nervous system. AE that simultaneously met the following conditions was considered as a risk signal: the number of report cases ≥3, lower limit of the 95% confidence interval of ROR≥1, PRR≥2, and χ2≥4. Results A total of 422 nervous system AE cases related to gifitinib were collected, involving 297 patients and 42 preferred terms (PT); 10 risk signals were detected, including dementia, brain oedema, demyelina- tion, leukoencephalopathy, hemiplegia, vocal cord paralysis, neurological symptom, cerebral atrophy, intracranial pressure increase and neuropathy, with 64 AE cases involved. One thousand seven hundred and fifty?five nervous system AE cases related to erlotinib were collected, involving 1?477 patients and 69 PT; 7 risk signals were detected, including ageusia, hyperaesthesia, facial pain, demyelination, motion sickness, vocal cord paralysis, peripheral paralysis, with 142 AE cases involved. Two hundred and forty?seven nervous system AE cases related to afatinib were collected, involving 212 patients and 32 PT; 7 risk signals were detected, including ageusia, cerebral infarction, brain oedema, epilepsy, central nervous system lesion, leukoencephalopathy, cerebral disorder, with 49 AE cases involved. Six hundred and fifty?two nervous system AE cases related to osimertinib were collected, involving 582 patients and 46 PT; 3 risk signals were detected, including cerebral infarction, vocal cord paralysis, facial paralysis, with 54 AE cases involved. Ageusia was an AE already included in the label of afatinib, while other AE were not included. Conclusion Most of the EGFR inhibitor?related AE signals found in the FAERS database are not included in the labels, and should be monitored during the clinical use.
  • 病例报告
    Gu Jianying;Xu Guixiang
    . 2007, 9(5): 378-378.
    A 39-year-old woman with hepatitis B and hepatic cirrhosis received IV tiopronin 0.2 g once daily.Thirty-nine days later,she developed obvious swelling of both parotid glands with mild tenderness.The next day,her bilateral retroauricular lymph nodes were enlarged.Tiopronin was discontinued immediately and replaced to IV reduced glutathione 1.2 g once daily.Two days later,the swelling of her parotid glands and retroauricular lymph nodes resolved gradually.
  • 安全用药
    Zhou Xiping;Li Hong
    . 2011, 13(1): 21-6.
    Iodinated contrast media (ICM) are the most commonly used drugs in diagnostic visualisation technique. ICM may be classified as ionic and nonionic according to their chemical structure or highosmolar, lowosmolar, and isoosmolar according to their osmolality. ICM are generally considered to be relatively safe, but serious adverse reactions may occur, such as severe immediate hypersensitivity reactions. Severe immediate hypersensitivity reactions may lead to angioedema, unconsciousness, profound hypotension, arrhythmias, respiratory arrest and cardiac arrest, and so on. The incidence rates of severe immediate hypersensitivity reactions to ionic and nonionic ICM are 0.1%- 0.4% and 0.02%- 0.04%,respectively. The most significant risk factor for an immediate hypersensitivity reaction is a history of a hypersensitivity reaction to contrast media. Other risk factors are the history of asthma and allergic history to drug or food, and so on. The mechanism of ICM-induced immediate hypersensitivity reactions may be related to histamine release from basophil and mast cells. Histamine release might be due to a direct membrane effect associated with the solution osmolarity or the chemical structure of ICM, an activation of the complement system, as well as the formation of bradykinin and the activation of antigenantibody reactions mediated by IgE. The preventive and therapeutic measures are as follows: (1) application of low-osmolar or iso-osmolar and nonionic ICM as far as possible; (2) the skin test and the premedication such as glucocorticoid and antihistamine to the patients with risk factors should be recommended; (3) the patients with moderate or severe hypersensitivity reactions to ICM should receive the symptomatic and supportive treatments.
  • 调查研究
    Fang Juaniuan;Li xuqin
    . 1999, 1(2): 99-101.
    Objective: To investigation ADR information on hematuria. Methods: To collect ADR cases of hema-turia from Chinese Pharmaceutical Abstract 1994 1998 and make an analysis. Results: In five years, there were 273 cases associated with 51 kinds of westeren medicines and traditional Chinese medicines. Among them 152 cases were induced by the compound diclofenac tablets, accounting for 55.4% . Conclusion: Great attention should be paid to drug-induced hematuria. The formulation of compound diclofenac tablets should be reevaluated.
  • 调查研究
    Gong Wenwu
    . 2001, 3(3): 156-159.
    Objective: To review ADRs related to compound danshen injection. Methods: Literature survey was based on national medical journals of 1990 - 2000. Results: 123 ADRs of 91 cases taking compound danshen injection were reported showing no differences in the patients' ages and twice more ADRs in male than in female. The occurrence of ADRs was commonly within two hours after injection. As to types of reaction, there were 94 allergic reactions (76.42%) and 29 other reactions (23.58%), the former being skin reactions (46), drug fever (20), anaphylactic shock (18), anaphylactic ashma (6), angioneuroedema (4). Contusion: The ADR is mostly in allergy with its mechanism analysed.
  • 药物评介
    . 2005, 7(5): 382-385.
  • 安全用药
    . 2002, 4(2): 93-95.
    本文介绍了丙戊酸钠肝毒性的临床表现为:肝酶增加、血氨升高、抑制凝血、低血糖和酸中毒、微囊状脂肪变性及抑制β氧化;并对其提出了预防和治疗措施。
  • 中毒救治
    Xie Lijing;Ding Maobai;Sun Chengye
    . 2008, 10(6): 0-0.
    Coriaria sinica Maxim is a Chinese herbal medicine. The plant contains sesquiterpene lactons, of which the main toxic components are coriamyrtin, tutin, etc. Coriamyrtin and tutin are a antagonist of γ-aminobutyric acid receptor. They cause the stimulation of the central nervous system and the enhancement of the spinal cord reflex, leading to convulsions. All parts of the plants are toxic, especially in unripe fruits. Ingesting the fruits 15~60 g may cause intoxication. The LD50 of coriamyrtin in mice by intramuscular injection is 1.75 mg/kg. Reports of accidental poisoning in children who eating the fruits are frequent. Generally, the onset time of intoxication symptoms after ingestion of Coriaria sinica Maxim is 0.5~3 h. Early symptoms of Coriaria sinica Maxim poisoning are nausea, vomiting, dizziness, headache, chest distress, abdominal disomfort. Anxiety, restlessness, increased blood pressure, accelerated respiration, generalized convulsion follow. The patients often died from cardiopulmonary arrest. Management includes gastric lavage, catharsis, administration with diazepam or phenobarbital, symptomatic and supportive treatment.
  • 论著
    Zhou Bing;Zhang Jun;Pei Zhen'e;Lin Xin;Zhan Siyan
    . 2008, 10(4): 0-0.

    Objective: To study the effects of gatifloxacin on blood glucose in order to provide scientific basis for clinical safe use of the drug. Methods: Four hundred and seventyfive inpatients receiving gatifloxacin or levofloxacin from 13 hospitals between May 2007 and October 2007 were enrolled in a follow-up study. The gatifloxacin group were 230 cases and the levofloxacin group were 245 cases. All patients were administered with an IV infusion of a dose of 400 mg daily for 7 days. Blood glucose levels were measured before drug administration, on day 4 after drug administration, and after drug discontinuation. Results: The incidence of high blood glucose and elevated blood glucose after drug discontinuation were greater in the gatifloxacin group than in the levofloxacin group (13.91% vs 6.53% and 18.70% vs 9.80%, respectively). The differences were statistically significant (P<0.01). The incidence of reduced blood glucose after drug discontinuation were greater in the levofloxacin group than the gatifloxacin group (36.73% vs 22.17%). The differences were statistically significant (P<0.01). The incidence of high blood glucose, elevated blood glucose, and reduced blood glucose after drug discontinuation to the gatifloxacin group were 12.90%, 17.74%, and 22.58% in diabetic patients, and 14.29%, 19.05%, and 24.40% in non-diabetic patients, respectively. The differences were no statistically significant (all P>0.05). Conclusion: Gatifloxacin can elevate or reduce blood glucose levels. Therefore, care should be taken and blood glucose levels should be monitored in clinical gatifloxacin use.

  • 实验论著
    Yang Jun;Jiang Dechun;Qi Xiaolian
    . 2009, 11(5): 321-4.
    Objective: To determine the serum concentrations of western medicine compositions in patients taking traditional Chinese antiepileptic preparations in order to benefit their rational use. Methods:From September 2006 to September 2007, 176 epileptic patients taking traditional Chinese antiepileptic preparations were enrolled in the study. The patients comprised 102 men and 74 women aged 3~63 years [average age (26.27±11.67)]. Their disease duration was 1~42 years [average disease duration (11.9±8.68) years]. The patients’fasting serum phenytoin, phenobarbital, valproate, and carbamazepine concentrations were determined with fluorescence polarization immunoassay. Results: Of 176 blood samples, 174 contained one or more than one the abovementioned western medicine compositions, but the western medicine composition was not detected in two blood samples from the two patients receiving Huafeng pills and Hupobaolong pills. One hundred and thirtytwo patients took traditional Chinese medicine alone and 44 patients took traditional Chinese medicine combined with western medicine. One hundred and sixty-nine epileptic patients’condition was not controlled; of them, 9 patients’ blood phenobarbital level is over the upper limit of effective concentration, and 2 of the 9 patients developed somnolence and decreased mentality. Conclusion: Close monitoring of blood drug concentration should be performed during the clinical use of traditional Chinese antiepileptic preparations for benefit to rational drug use.
  • 论著
    ang Yue;Li Xuerong;Zhong Ren;Yang Jing;Sun Lirong
    . 2011, 13(5): 278-5.
    Objective: To compare the efficacy and safety of pegaspargase (PEG-Asp) and L-asparaginase (L-Asp) in treatment of children with acute lymphocytic leukemia (ALL) in order to provide a basis for the selection of chemotherapy regimen for children with ALL. Methods: The clinical data of children with ALL who received intensive treatment with PEG-Asp (PEG-Asp group ) or L-Asp(L-Asp group) at Department of Pediatric Haematology,the Affiliated Hospital of Medical College, Qingdao University from March to December 2010 were collected and analysed. The children in both groups received intensive treatment with vincristine, pirarubicin, and prednisone. In addition, the PEG-Asp group was given IM pegaspargase 2500 U/m2 once every two weeks for two times, and the L-Asp group was given an IV of L-Asp 6000 U/m2 once every other day for eight times. Laboratory tests, including routine blood, coagulation function, serum amylase, urinary amylase, blood glucose and liver function, were performed regularly, and bone marrow examination was conducted before and after chemotherapy. The duration of remission and hospitalization were recorded. The efficacy of treatment and adverse reactions were observed. The adverse reactions were classified as grades 0-4 according to common terminology criteria for adverse events 3.0 (CTCAE v3.0) formulated by National Cancer Institute (NCI). Results: The PEG-Asp group comprised 20 boys and 20 girls with median age of 6.3 years. The L-Asp group comprised 33 boys and 27 girls with median age of 6.7 years. The children in the 2 groups were complete remission by results of bone marrow examination before intensive treatment and the duration of follow-up after intensive treatment. The difference in the duration of complete remission between the PEG-Asp group [(13.2±2.0)month] and the L-Asp group[(13.9±1.8)month]was not statistically significant. The average days of hospitalization was shorter in the PEG-Asp group[(11.5±7.1)d]than those in the L-Asp group[(18.5±4.9)d], the difference was statistically significant (P<0.05). The positive rates of skin tests in the PEG-Asp group and the L-Asp group were 10.0% and 21.7% respectively, the difference was not statistically significant. During the intensive treatment, allergic reactions such as rash or swelling of lip and throat or diarrhea appeared in the PEG-Asp group (1 case) and the L-Asp group (4 cases), the coagulation disorder, leukopenia, neutropenia, thrombocytopenia, decreased hemoglobin level and increased levels of alanine aminotransferase, total bilirubin, total cholesterol, urea nitrogen, blood sugar as well as hypoproteinemia appeared in all children in the two groups. There was no statistically significant difference in the distribution of patients with adverse reactions between the two groups. Conclusion: PEG-Asp and L-Asp are safe and effective in the intensive treatment of children with acute lymphocytic leukemia, their pattern and grade of adverse reactions are similar, but PEG-Asp has the features of lower frequency of administration and shorter duration of hospitalization.
  • Zhang Yinan, Zhao Zhigang
    Adverse Drug Reactions Journal. 2021, 23(2): 57-62. https://doi.org/10.3760/cma.j.cn114015-20210210-00176
    With the rapid development of the medical industry, patient safety has attracted more and more attention. Medication safety is an important part of patient safety. Research on medication safety of patients started earlier in the United States, a relatively perfect adverse event reporting and risk management mechanism has formed, and a lot of experience on medication safety in the research and practice has been accumulated. Britain and Australia have published their strategies and suggestions on improving medication safety on government websites and achieved certain results. At present, the problem of medication safety in China is still serious, so it is urgent to strengthen the improvement of medication safety. We should learn from the experience of the above countries and make efforts in establishing medication safety teams, making full use of information technology, strengthening the monitoring and reporting of medication risk, using self-assessment projects to improve safety management, and guiding pharmacists to go deep into clinical work, etc., so as to improve the current situation of medication safety in China.
  • Zhang Xinfeng, Qiao Cuixia, Cheng Xufeng, Wang Huaizhang, Yang Xuchu, Gao Qilong
    . 2015, 17(6): 457-459.
    A 57-year-old male patient received oral sorafenib 400 mg twice daily for pulmonary metastases after operation of thyroid carcinoma. About 3 and a half months of treatment, the patient experienced dizziness, pain in the anterior region of the heart and blood pressure of 180/105 mmHg (before treatment it was 120/75 mmHg). He received oral metoprolol administration (initial dose of 25 mg twice daily, gradually increased to 200 mg twice daily). About one and a half months later, he received sustained release capsules of isosorbide mononitrate 50 mg once daily because of the intermittent attack of precordial pain. Angina pectoris still occurred frequently. He underwent percutaneous coronary intervention twice (a total of 2 stents implantation). Hypertension and angina pectoris were still poorly controlled. On month 19 of sorafenib treatment, the dose of drug was reduced to 400 mg once daily. His blood pressure was 135/85 mmHg but angina still occurred intermittently. On month 22, sorafenib was stopped. Two months later, the patient′s blood pressure declined to 130/80 mmHg, and the frequency of angina pectoris decreased. Four months after the termination of sorafenib, his blood pressure was 120/75 mmHg and no episode of angina pectoris occurred.

     

  • Xu Jingpu, Kong Wei, Dai Wenting, Zheng Liya, Fu Changfang
    . 2015, 17(4): 310.
    A 65-year-old female patient was given treatment scheme of bevacizumab (0.386 g, the first day), oxaliplatin (150 mg, the first day) and capecitabine (1 g, twice daily, the first day to the 14th day) for colon cancer with liver metastasis. Twenty-three days after administration, the patient developed upper abdominal pain. She was diagnosed of gastrointestinal perforation and diffuse peritonitis by abdominal X-ray and CT scan. Emergency exploratory laparotomy was performed and a perforation with a size about 5 cm×2 cm was found at the location of ascending colon 5 cm away from ileocecus. Then an ascending colon and terminal ileum fistula operation was performed. After the patient's condition was stable, she was given oxaliplatin and capecitabine to continue treatment.
  • Han Junwei, Li Yuanping, Cheng Yao, Wang Xiaocheng, Zhou Min, Song Jianbo
    Adverse Drug Reactions Journal. 2022, 24(3): 130-138. https://doi.org/10.3760/cma.j.cn114015-20210625-00716

    Objective To systematically evaluate the risk of severe gastrointestinal events in patients with cancer caused by vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR- TKI). Methods Randomized controlled trials of VEGFR-TKI in the treatment of tumors were collected by searching relevant databases at home and abroad (up to March 2, 2019). The patients who were treated with a VEGFR-TKI were enrolled into the trial group, and those who received placebo or another VEGFR-TKI were enrolled into the control group. The outcomes included the incidence of serious gastrointestinal events. The Jadad scoring method was used to assess the quality of included studies. The Review Manager 5.3-software was used for direct meta-analysis on the risk of severe gastrointestinal events. Stata 13.0-software and linear mixed model based on frequency framework were used for network meta-analysis on severe gastrointestinal events at the highest risk. The results were expressed by relative risk (RR) and its 95% confidence interval (CI). Results A total of 38-studies were included in the analysis, all of which were high-quality studies (Jadad score 4-7), comprising a total of 15-217 patients (9-130 in the trial group and 6-087 in the control group). The results of direct meta-analysis showed that the risks of severe diarrhea, severe anorexia, and severe nausea in the trial group were higher than those in the control group respectively, and the differences were statistically significant [6.8% (602/8-894) vs. 0.7% (49/6-584), RR=6.62 (95%CI: 5.00-8.76), P<0.001; 2.5% (201/7-937) vs. 0.7% (41/5-831), RR=2.14 (95%CI: 1.40-3.25), P<0.001; 1.5% (92/6-343) vs. 0.4% (21/4-870), RR=1.95 (95%CI: 1.23-3.12), P=0.005]; the risk of severe diarrhea was the highest [6.8% (602/8-894)]. There was no significant difference in the risk of severe vomiting and severe abdominal pain compared with the control group [1.4% (79/5-788) vs. 0.7% (32/4-428), RR=1.49 (95%CI: 0.90-2.47), P=0.120; 1.7% (82/4-766) vs. 1.1% (40/3-628), RR=1.35 (95%CI: 0.84-2.16), P=0.210]. The results of network meta-analysis on risk of severe diarrhea events showed that the relative risks of severe diarrhea caused by varieties of VEGFR-TKI were axitinib>anlotinib>cabozantinib≈vandetanib≈sunitinib≈lenvatinib≈sorafenib≈pazopanib>regorafenib>fruquintinib>apatinib in the order. Conclusion The application of VEGFR-TKIs, especially axitinib, can increase the risk of severe diarrhea in patients with tumors, which deserves clinical attention and vigilance.

  • Zhang Lin, He Congcong, Zhao Jiani, Lyu Jing, Zhang Yueying
    Adverse Drug Reactions Journal. 2023, 25(12): 748-754. https://doi.org/10.3760/cma.j.cn114015-20230426-00318
    Post-contrast acute kidney injury (PC-AKI) is one kind of the serious adverse reactions of iodine contrast agents. With the rapid development of computed tomography technology, the use of intravenous iodine contrast agents has significantly increased. Although the incidence is very low, PC-AKI after intravenous injection has attracted attention. At present, there is no effective treatment measure which is evidence-based for PC-AKI. Effective risk prediction and prevention of PC-AKI are important measures to reduce the occurrence risk and relieve the kidney injury. Rehydration therapy is currently recommended in clinical practice for the prevention and treatment of PC-AKI. In recent years, there are also many scholars studying the prevention and treatment measures such as remote ischemic precondition, drug therapy, and renal replacement therapy.
  • 病例报告
    Chu Yanqi;Yan Suying;Wang Yuqin
    . 2009, 11(4): 285-2.
    Three women aged 28~45 years underwent hysterotomy or laparoscopic exploration. After surgery, their incisions were sprayed with fibrin glue (each vial contains fibrinogen 50 mg, factor Ⅷ 10 U, and thrombin 400 U). About 3~15 minutes after spraying, all three patients developed rash and patients 1 and 2 also had dyspnea. Symptomatic treatment was given and their symptoms gradually improved.
  • 中药不良反应
    . 2006, 8(5): 392-392.
  • 调查研究
    Liu Guiyang;Chai Dong;Qian Jiao;Wang Rui
    . 2005, 7(3): 175-178.
    Objective:To investigate the knowledge level of antibacterials rational use among health professionals(HP) in a general hospital. Methods: A questionnaire survey was conducted in 299 subjects with different ranks of professional title. Results: On a hundred-mark system, the average was 67.4±14.7 in HP. The comparison of their cognitive abilities was as follows: pharmaceutists were much better than doctors and nurses, HP in internal medicine better than HP in surgery, and middle-ranking HP had good marks in this survey, followed by senior HP and junior HP. Conclusion: It is necessary to conduct training courses for HP in order to improve their knowledge of antibacterials rational use.
  • ADR监测与防治
    . 2000, 2(4): 241-243.
  • . 2015, 17(6): 401-402.
  • 药物评介
    . 1999, 1(3): 195-197.
  • Tu Kangwan, Zhu Yinfang, Tang Qin, Zhou Min, Fu Decai, Xu Shufan, Du Fanfan, Su Qilin
    Adverse Drug Reactions Journal. 2023, 25(5): 315-317. https://doi.org/10.3760/cma.j.cn114015-20220515-00434
    Two patients (patient 1, a 61-year-old male; patient 2, a 58-year-old female) received red yeast rice 6 g once daily orally because of abnormal blood lipids. Patient 1 had schistosomal cirrhosis and cholestatic hepatitis, with triacylglycerol 5.32-mmol/L. After 26 days of oral administration of red yeast rice, the patient developed limb weakness, with creatine kinase (CK) 604-U/L. Red yeast rice was stopped immediately and 3 days later, the patient developed lower limb muscle soreness, with CK 117-748-U/L. After 12 days of treatments with dexamethasone and rehydration, his symptoms gradually disappeared, with CK 79-U/L. Patient 2 had acute hepatitis, with triacylglycerol 2.34-mmol/L. After 24 days of oral administration of red yeast rice, the patient developed weakness and muscle soreness in both lower limbs, with CK 52-222-U/L. Red yeast rice was stopped immediately, and after 12 days of treatments with methylprednisolone and hydration, her symptoms were improved, with CK 210-U/L.
  • 安全用药
    . 2003, 5(6): 390-392.
    榄香烯乳注射液属二类抗肿瘤新药。其主要成分为中药温莪术提取物β-榄香烯,属挥发油类,主要用于恶性肿瘤的治疗。榄香烯乳注射液的主要不良反应包括静脉炎、发热、疼痛、诱发出血、过敏反应和药液外渗(漏)致局部组织坏死等。本文对其不良反应及其防治措施加以介绍。
  • 中药不良反应
    LI De-min;YANG Dao-wen;ZHANG Shu-nan
    . 2013, 15(1): 55-3.

    A 54-year-old female patient with rheumatoid arthritis, osteoarthropathy received leflunomide 20 mg,once daily. After 5 months of therapy, 4 Yuxuebi capsules thrice daily was added to her regimen. About five hours after took the second dose of Yuxuebi, the patient′s body temperature rose to 38.8 ℃, red rashes appeared on her palm and rapidly progressed to involve her entire body, accompanied by pharyngeal pain, dizziness, chest distress, asthenia, abnormal vision. Her blood pressure was 86/47 mm Hg. He received anti-allergic treatment such as calcium gluconate, vitamin C, hydrocortisone sodium succinate, and loratadine combined with Chinese herbal decoction. On day 2 of admission, laboratory tests showed the following values: white blood cell count 18.3×1012/L, neutrophils 0.96, C-reactive protein 148 mg/L, procalcitonin 2.16 ng/ml, alanine aminotransferase 54 U/L, aspartate aminotransferase 55 U/L, direct bilirubin 7.8 μmol/L, urea 11.2 mmol/L, and creatinine 209 μmol/L. X-ray showed lung infection. An IV infusion of cefoxitin sodium was given. On day 3 of admission, the patient′s body temperature returned to normal, and she developed allergic stomatitis. She was treated with oral Kangfuxin Ye (康复新液) and gargled with compound chlorhexidine gluconate gargle. On day 8 of admission, her anaphylactic symptoms disappeared.

  • Shen Qushen, Chen Chibang, Zhou Yongheng, Peng Nanxing, Liu Chunxia
    . 2016, 18(4): 314.
    A 24-year-old male patient with viral meningoencephalitis received intravenous infusion of acyclovir 0.5 g thrice daily, Xingnaojing injection (醒脑静注射液) 20 ml once daily, mannitol injection 250 ml thrice daily, creatine phosphate sodium 1 g once daily, insulin injection (6 U+5% glucose injection 500 ml+ potassium chloride injection 10 ml), Xueshuantong injection (血栓通注射液) 500 mg once daily, mecobalamin injection 2 ml once daily, and oral butylphthalide soft capsules 0.2 g thrice daily, ranitidine bismuth citrate capsules 0.2 g twice daily, etc. On day 7, the patient developed visual blurring and could not see distant objects clearly. At the same time, the patient experienced mydriasis with diameter about 5.0 mm and conjunctival congestion. Acyclovir was discontinued and other drugs were continued. Five days after withdrawal, his symptoms of conjunctival congestion, mydriasis, and vision were improved. At 2 months of follow-up, blurred vision did not recur.
  • Li Gang, Chen Min
    . 2016, 18(5): 330.
    ObjectiveTo evaluate the efficacy and safety of adjuvant therapy combined with everolimus in theatment of breast cancer.MethodsThe related data-bases were searched. The RCTs in neoadjuvant therapy or adjunctive therapy for breast cancer in combination with everolimus (experimental group) or placebo (control group) were collected.  The RCTs were Meta-analyzed using RevMan 5.3 software. The efficacy and safety of the two groups were compared. The results were shown by relative risk (RR), hazard ratio (HR) and 95%CI.ResultsEight RCTs and 2 877 patients were enrolled into the Meta-analysis, including 1 679 patients in the experimental group and 1198 patients in the control group. Two RCTs applied neoadjuvant therapy and 6 RCTs applied adjunctive therapy. The results of quality evaluation of 8 reports showed 2 of low risk and 6 of unknown risk. Meta-analysis show the following results. The effective rate of the experimental group  and the control group applying neoadjuvant therapy were 92.6% (150/162) and 88.7% (141/159), the difference was not statistically significant (RR=1.04, 95%CI: 0.97-1.12, P=0.23). The effective rate of the experimental group  and the control group applying adjunctive therapy were 83.0% (1 081/1 303)and 76.0%(623/820), the difference was not statistically significant(RR=1.12, 95%CI: 0.96-1.29, P=0.14).  The progression-free survival of the patients in the experimental group applying adjunctive therapy were longer than that in the control group, the difference was statistically significant (HR=0.60, 95%CI: 0.44-0.82, P=0.001).  The overall survival of the patients in the experimental group applying adjunctive therapy were longer than that in the control group, but the the difference was not statistically significant (HR=0.74, 95%CI: 0.48-1.16, P=0.19). The evaluation results of safety showed the following results. The incidence rates of erythra, fatigue, and anemia in the experimental group applying neoadjuvant therapy were higher than those in the control group, the differences were statistically significant (all P<0.05). The incidence rates of stomatitis, erythra, diarrhoea, loss of appetite, dyspnea, peripheral edema, pneumonia, thrombocytopenia, aleucocytosis, and lymphocytoponia in the experimental group applying adjunctive therapy were higher than those in the control group, the differences were statistically significant (all P<0.05).ConclusionsIt is necessary to discuss whether combination  with everolimus in neoadjuvant therapy before operation having a forward benefit. Combination  with everolimus in adjunctive therapy after operation can prolong the patients′s  progression-free survival. The ADR type induced by combination with everolimus in neoadjuvant therapy is less than that in adjunctive therapy. The results of  the study are only for low-intensity recommendation.
  • 安全合理用药
    Kong Jian;Sun Zhongshi;Zhu Zhu
    . 2008, 10(3): 195-4.
    Fentanyl is an opioid agonist, and is a potent narcotic analgesic. It is one of the most commonly used narcotic analgesics in clinical practice. Three fentanyl sustainedrelease preparations on the market now include fentanyl transdermal system, oral transmucosal fentanyl citrate, and fantanyl buccal tablets. These fentanyl preparations should only be used for patients who are opioidtolerant and chronic pain that is not well controlled with other analgesics. They are not to be used to treat sudden, occasional, or mild pain or pain after surgery. Death and lifethreatening adverse effects may occur after doctors inappropriately prescribe the preparations of fentanyl or patients incorrectly use them. The symptoms of fentanyl overdose include trouble breathing, slow heartbeat, severe sleepiness, trouble walking or talking, feeling faint, dizzy, and confused. The dosage strength of fentanyl in a certain product is not to the same dosage strength of fentanyl in other fentanylcontaining products. Therefore, they must be not directly substituted with each other. If necessary, the conversion of dosage should be performed.
  • 病例报告
    . 2004, 6(2): 124-124.
  • 安全合理用药
    Xia Peiyuan
    . 2008, 10(5): 0-0.

    The term hazardous drugs refer to the drugs that have carcinogenicity, teratogenicity, reproductive toxicity, genotoxicity, organ toxicity at low doses, including antineoplastic agents, antiviral agents, hormones, immunosuppressive agents, and so on. A large number of studies have showed that healthcare workers who prepare or administer hazardous drugs may have the risks for occupational exposure to these drugs. Exposures to hazardous drugs may occur through inhalation of respiratory tract, skin contact, skin absorption, ingestion of alimentary tract, and so on. Inhalation and skin contact/absorption are the most likely routes of exposure to hazardous drugs. Occupational exposure to hazardous drugs can lead to decrease in immunity, increase in risk for cancer occurring, and potential reproductive damage. The common adverse effects of hazardous drugs are dizziness, fatigue, alopecia, cough, nausea, vomiting, abnormal menstruation, and skin rash. In addition, chronic liver damage may occur after long-term exposure to hazardous drugs. In order to diminish the risk of exposure to hazardous drugs to healthcare workers, the following safe protective procedures should be included: Good work practice should be formulated; The health care workers who have potential contact with these hazardous drugs should receive a safety education and training; Preparation should be carried out in designated area; Use of biological safety cabinets; Personnel protective equipment (including gloves, isolation gowns, safety glasses, face shields, and respirators) should be worn; Adequate care should be taken in the disposal of waste material; Acute exposure to hazardous drugs should be managed promptly.

  • 病例报告
    . 2006, 8(5): 385-385.
  • Adverse Drug Reactions Journal. 2017, 19(5): 368.
  • 病例报告
    Wei Ming;Niu Xiangping
    . 2014, 16(3): 179-1.
    A 67-year-old female patient received midazolam maleate 7.5 mg at bedtime for insomnia. She experienced falling asleep fast and better sleep quality during the initial treatment period. Three months later, she self-medicated double dosage due to poor sleep. Two months later, she developed auditory hallucination occasionally during the daytime and suffered somnambulism frequently at night, and complicated by delirium and agitation. Midazolam maleate was discontinued and switched to doxepin 25 mg every night. At a follow-up 2 weeks later, the symptoms of somnambulism and delirium disappeared.
  • Li Taoming, Zou Le, Hu Lin, Yin Tao
    Adverse Drug Reactions Journal. 2020, 22(1): 20-24. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.01.005
    Objective To explore the occurrence and clinical characteristics of antibacterial-associated encephalopathy (AAE) in patients with chronic kidney disease (CKD). Methods The electronic medical records of patients with CKD stages 3-5 and treated with antibacterials for more than 2 days during hospitalization in Xiangya Hospital of Central South University from January 1 to December 31, 2016 were collected. The patients who were with neuropsychiatric symptoms or diagnosed as encephalopathy after antibacterials treatments were screened out and scored by clinicians and pharmacists using Naranjo evaluation method. The patients with scores of ≥ 4 were judged as AAE. The AAE patients′ basic information, basic disease information, application of antibacterials, and AAE related information were extracted and analyzed descriptively. Results A total of 977 (40.07%) of 2-438 inpatients with CKD stages 3-5 were treated with antibacterials. Thirty-three patients (3.38%) were judged to have AAE by comprehensive evaluation. Among 33 patients with AAE, 15 patients were male and 18 were female, with age of 68 (56, 78) years (ranging from 27 to 88 years); 2 patients were with CKD stage 3b, 6 patients with stage 4, and 25 patients with stage 5; 21 patients underwent dialysis; their serum creatinine was (492±265) μmol/L, blood urea nitrogen was (16.9±10.7) mmol/L, and estimated glomerular filtration rate (eGFR) was 10.4 (7.0, 14.9) ml/(min·1.73 m2). The antibacterials related to AAE were beta-lactams and fluoroquinolones, of which cefepime had the highest incidence of AAE [28.57%(4/14), 95%CI: 1.5-55.6], followed by ceftazidime [14.67%(11/75), 95%CI: 6.5-22.9]. The time from the use of antibacterials to the occurrence of AAE was (6±3) days. The main clinical manifestations of AAE were delirium and mania (45.45%, 15/33), involuntary movement of limbs and epilepsy (18.18%, 6/33 for both), apathy (15.15%, 5/33), lethargy (12.12%, 4/33), delusion and hallucination (3.03%, 1/33). Thirty-three patients with AAE were treated with discontinuation or replacement of antibacterials, intensive dialysis, hemofiltration, and symptomatic treatments. By the time of discharge, the symptoms in 30 patients (90.9%) disappeared and 3 patients (9.10%) were not cured. Conclusions The patients with CKD were at increased risk for AAE, especially for those treated with beta-lactams. The dosage of antibacterials drugs should be adjusted according to eGFR in CKD patients and monitored during the treatment so as to prevent the occurrence of AAE.
  • Zhou Cuiyun, Chen Huiqing
    Adverse Drug Reactions Journal. 2020, 22(10): 563-567. https://doi.org/10.3760/cma.j.cn114015-20190906-00740
    Objective To investigate the occurrence of adverse reactions in healthy females after vaccination with human papillomavirus (HPV) vaccine. Methods The subjects were healthy females of the right ages who were vaccinated with 4-valent HPV vaccine and 9-valent HPV vaccine in Beijing Friendship Hospital, Capital Medical University from February 2018 to June 2019. The basic information (age, identity, education, and etc.), vaccination, adverse reactions, and outcomes of HPV vaccine recipients were collected by the self-established HPV vaccine recipient information login system and analyzed retrospectively. The differences of adverse reactions of recipients with different vaccines and different times of vaccines were compared. Results A total of 677 recipients were enrolled in the analysis. Five hundred and ten reci- pients with an age of (33±6) years received the first dose of 4-valent HPV vaccine, and 467 of them received the second dose; 167 recipients with an age of (24±2) years received the first dose of 9-valent HPV vaccine, and 118 of them received the second dose. Among the 677 recipients, 533 (78.7%) were cadres or office workers, 85 (12.6%) were students, and 59 (8.7%) were housewives; 525 (77.5%) had bachelor degree or above and 152 (22.5%) had below bachelor degree. The adverse reactions after HPV vaccination included injection site local reactions (including pain, swelling, and induration) and systemic reactions (including fever, nausea, fatigue, and menstrual cycle disorders). The differences in the incidences of overall and local adverse reactions after inoculations between the first dose of 4-valent HPV vaccine and the first dose of 9-valent HPV vaccine were statistically significant [2.5% (13/510) vs. 15.6% (26/167), χ2=39.283, P<0.001; 1.6% (8/510) vs. 12.6% (21/167), χ2=37.169, P<0.001], but the difference in the incidence of systemic reactions was not statistically significant [1.0%(5/510)vs. 3.0%(5/167), χ2=3.505,P=0.061]. The differences in the incidences of overall adverse reactions, local reactions, and systemic reactions between the second doses of 4-valent HPV and 9-valent HPV vaccines were not statistically significant [1.3% (6/467) vs. 2.5% (3/118), χ2=0.984, P=0.321; 0.6% (3/467) vs. 2.5% (3/118), χ2=3.350, P=0.067; 0.6% (3/467) vs. 0 (0/118), χ2=0.762, P=0.383]. The differences in the incidence of local and systemic adverse reactions between the first and the second dose of 4-valent HPV vaccine were not statistically significant [1.6% (8/510) vs.0.6% (3/467), χ2=1.879, P=0.171; 1.0% (5/510) vs. 0.6% (3/467), χ2=0.343, P=0.558]. The difference in the incidence of local adverse reactions between the first dose and the second dose of 9-valent HPV vaccine was statistically significant [12.6% (21/167) vs. 2.5% (3/118), χ2=9.024, P=0.003], and the difference in the incidence of systemic adverse reactions was not statistically significant [3.0% (5/167) vs. 0(0/118), χ2=3.596, P=0.058]. The local or systemic reactions after vaccination did not need treatment and could be self-relieving. Conclusions A few healthy females vaccinated with 4-valent or 9-valent HPV vaccines may have adverse reactions, most of which are mild and self-relieving. The adverse reactions of the 2 HPV vaccines mainly occur after the first dose of vaccination. The incidence of adverse reactions of the first dose of 9-valent HPV vaccine is higher than that of the first dose of 4-valent HPV vaccine.
  • Tian Xu, Zhang Hongmei, Sun Lirui, Guo Qiushi, Zhou Wei
    Adverse Drug Reactions Journal. 2020, 22(8): 486-487. https://doi.org/10.3760/cma.j.cn114015-20190423-00382
     A 56-year-old female patient received epalrestat 50-mg thrice daily orally because of the diagnosis of diabetic peripheral neuropathy. After 3 times of epalrestat treatment that day (about 10-hours after the first medication), the patient developed red papules on the face and patch-like erythema on the head and neck. On day 2 of epalrestat treatment, the rashes were progressively aggravated and the patient was diagnosed with erythema multiforme-type drug eruption. Considering that it might be caused by epalrestat, the drug was replaced by lipoic acid injection and symptomatic treatments with dexamethasone, vitamin C injection, and calcium gluconate injection were given. Three days later, the patient′s allergic symptoms were alleviated. Anti-allergic drugs were phased out gradually while the other drugs were continued. Six days later, the patient had no discomfort and was discharged from the hospital. At 20 days of follow-up, the rashes did not recur.
  • 调查研究
    Li Chuna;Liu Enshengb;Mu Ronga;Li Zhanguoa
    . 2010, 12(1): 21-5.
    Objective: To explore the incidence and risk factors of retinopathy induced by hydroxychloroquine. Methods:Search words such as hydroxychloroquine, antimalarials, eye, ocular, retinopathy, maculopathy, and retinotoxic were selected, and MEDLINE, EMBASE, OVID, Science Direct, and Springer databases were searched. The data of clinical use of hydroxychloroquine from the English literature published between 1963 and 2008 were collected. According to the criteria for entering, literature were strictly selected; incidence of retinopathy and nonretinopathy induced by hydroxychloroquine were calculated; relationship between the dosage of hydroxychloroquine, the length of drug use and retinopathy induced by hydroxychloroquine were analyzed. Results: Twenty one papers were selected. Of them, 11 were prospective study and 10 were retrospective study. A total of 5 210 patients entered the study. Of them, 25 patients had retinopathy and its incidence was 0.48%. In the prospective and retrospective studies, the incidences of retinopathy were (0.43% 11/2 549)and 0.53% (14/2 661), respectively. Ten of the 21 papers had evaluation of nonretinopathy and 2 599 patients entered the study. Of them, the incidences of corneal deposit and ocular muscle imbalance were 0.50% and 023%, respectively. Average daily dosage of hydroxychloroquine treatment was (7.6±3.4)mg/(kg·d)in the 25 patients developing retinopathy. The incidence of retinopathy was 0.40%(17/4 292)in patients receiving the dosage ≤6.5 mg/(kg·d) and 0.87%(8/918)in those receiving>6.5 mg/(kg·d). There was no significant difference between the two different dosages(P=0068). The average duration of hydroxychloroquine treatment was(63.5±56.5)months. The average time of drug use to retinopathy onset was (78.9±74.0)months in 17 patients receiving dosage ≤6.5 mg/(kg·d)and (46.8±20.2) months in 8 patents receiving dosage >6.5 mg/(kg·d). During 3 months of followup after drug discontinuation, of 25 patients, 9 patients’retinopathy was stable, 2 patients’visual field improved slightly, 1 patient’s retinopathy aggravated, and other 13 patients’outcome was not stated. Conclusion: Hydroxychloroquine might cause retinopathy, which is an irreversible lesion. Its incidence is lower and risk factors are dosage and the length of drug use. Therefore,correct dosage should be given and ocular examination should be performed regularly during the clinical use of hydroxychloroquine.
  • 论著
    Huang Daoqiu;Li Baiqun
    . 2009, 11(1): 17-6.

    Objective: To study the safety and efficacy of compound moxiflocacin ear drops to experimental animals. Methods:In skin irritation testing, 20 rabbits were divided into 2 groups: the normal skin group and the damaged skin group (10 rabbits in each group). Compound moxifloxacin ear drops 1 ml and normal saline 1 ml were applied to the right and left sides in the one and same rabbit once daily for 7 days, respectively. The skin reactions were observed and scored.In skin allergy testing, 30 guinea pigs were divided into the following three groups: the compound moxifloxacin ear drops group, the 1% 2,4dinitrochlorobenzene group, and the normal saline group (10 guinea pigs in each group). The depilated areas of guinea pigs in the three groups were applied with 0.5 ml of abovementioned three medications, respectively. Allergic skin reactions were observed 6, 24, 48, and 72 hours after administration. In acute toxicity testing, 100 mice were devided into 2 groups: the subcutaneous injection group and the intraperitoneal injection group (50 mice in each group). Every group was redivided into 5 variable dosage groups: 40, 32, 26, 20, and 16 ml/kg in the subcutaneous injection group, and 32, 26, 21, 16, and 13 ml/kg in the intraperitoneal injection group. The mortality of the mice was observed for 7 days. LD50 and 95% confidence interval were calculated. In the efficacy study, 30 rabbit models of otitis media were randomly divided into 5 groups as fellows: the three variable dosage of compound moxifloxacin ear drops treatment groups, the ofloxacin ear drops positive control group, and the blank control group (6 rabbits in each group). In the three variable dosage of compound moxifloxacin ear drops treatment group, 0.8, 0.5, and 0.2 ml of compound moxifloxacin ear drops were applied into the ear three time daily, respectively. In the ofloxacin ear drops positive control group, 0.5 ml of ofloxacin was applied into the ear three times daily. In blank control group, nothing was applied. The efficacy to otitis media was evaluated one week after treatment. Results: No compound moxifloxacin ear dropsinduced erythema, swelling, and allergy were found. The subcutaneous and intraperitoneal LD50 were 25.55 ml/kg and 22.58 ml/kg for mice, respectively. The rate of high efficacy to the three variable dosages of compound moxifloxacin ear drops and the ofloxacin ear drops were 83.3%~100% and 666%, respectively, compared with the blank control group. Conclusion: Compound moxifloxacin ear drops is a safe and effective agent in treatment of otitis media.

  • 不良事件
    . 2006, 8(2): 156-156.
  • 调查研究
    Li Yueling;Huang Zuojun;Wu Yuanshan;Zheng Qikun
    . 2000, 2(3): 159-164.
    Objective: To check if antibacterials were rational in clinical use. Methods: 143 inpatients between June and December 1998 were enrolled for retrospective analysis of drug administration. Results: 132 cases took antibacterial drugs accounting for 92.3% , among them 69 cases (52.3%) for treatment and 63 cases (47.7%) for preventive purposes. From the said patients only 16 samples were collected and sent for bacterial culture, its positive rate being 31.5% . Antibacterials taken covered 43 kinds of 10 categories, altogether 1573 drug-days. The rate of the unreasonable application was 39.4% (52/132 cases) or 42.5% (668/1573 drug-days) . Medication for wrong indications or for a longer period than neccessity could be the main problem. Conclusion: In order to upgrade the diagnostic and therapeutic level, medical professionals should have knowledge of and be familiar with antibacterials and use them in a reasonable way in combination with bacterial culture and drug sensitivity test, if possible.
  • 药物滥用
    . 2005, 7(1): 32-36.
    精神活性物质滥用对个人和社会造成严重危害。物质滥用包括非违禁物质的滥用,违禁物质的非法使用。被滥用的违禁物质和非违禁物质均为依赖性物质(或药物),具有强化作用与奖赏效应,使用者将出现愉悦欣快的精神效应,引起一些人非医疗目的周期性或连续地使用该物质,使脑发生复杂的不良变化,最终导致对该物质的依赖和成瘾。物质成瘾是慢性、复发性脑疾病,具有强迫性觅药和用药而不顾及不良后果的行为特征。物质依赖不是缺乏意志和力量的问题,而是一种影响任何人的医学疾病。当前采用药物治疗物质依赖性和行为干预的方法减少其危害已取得成效,但大多数成瘾者仍然得不到相应的治疗。要减低物质滥用及相关疾病所造成的负担,必须依靠以证据为基础的治理政策和规划。
  • 实验论著
    Hu Zhonghui;Wu Chunqi;Wang Quanjun;Wang Qingxiu;Yang Baohua;Shi Chang;Liao Mingyang
    . 2010, 12(2): 83-8.
    Objective: To observe the effects of a single injection of Lianbizhi on the endogenous metabolite in SD rat urine using metabonomics technique in order to explore the mechanisms of Lianbizhi-induced renal damage. Methods:Two kinds of Lianbizhi injections were used in this experiment as follow: Lianbizhi A containing andrographolide sodium bisulfis 98.7% and other related substance 1.3%, Lianbizhi B containing andrographolide sodium bisulfis 49.1% and other related substance 50.9%. Twenty five SPF male SD rats were randomly divided into five groups: the high-dose(1 600 mg/kg)and low-dose (400 mg/kg) Lianbizhi A groups, the high-dose(400 mg/kg)and low-dose (100 mg/kg) Lianbizhi B groups, and the control group (normal saline). Each group comprised 5 rats. All rats received respectively a single intravenous injection of Lianbizhi 10 mL/kg via caudal vein. The rat urine samples were collected over a 12 hours period before dosing, as well as within 0~6, 7~12, 13~24 and 25~48 hours after dosing respectively, and 1H nuclear magnetic resonance (1H NMR) spectra of urine samples were measured. The blood biochemical indices were measured 48 hours after dosing. Results: The results of blood biochemical indices testing showed that the ALP level in the high-dose Lianbizhi A group and highdose Lianbizhi B group were respectively (306±13) and (294±45) U/L ,which were higher than that [(207±47) U/L] in the control group. The ALB levels in the high-dose Lianbizhi A and Lianbizhi B groups were respectively (28.26±1.07) and (27.34±1.01) U/L, which were higher than that [(25.70±0.37) U/L] in the control group. The TP levels in the highdose Lianbizhi A and Lianbizhi B groups were respectively (51.32±3.36) and (50.10±2.36) g/L, which were higher than that [(45.76±1.73 )g/L] in the control group, all differences were statistically significant (all P<0.05). In addition, the BUN levels in the high and low-dose Lianbizhi A groups as well as high-dose Lianbizhi B group were respectively (6.94±0.49), (6.69±0.31), and (6.81±0.38) mmol/L, which were higher than that [(5.90±0.45 ) mmol/L] in the control group, the differences were statistically significant ( P<0.05). The TG levels in the high- and low-dose Lianbizhi B groups were respectively (1.13±0.36) and (0.84±0.18)mmol/L, which were higher than that [(0.57±0.10) mmol/L] in the control group, the differences were statistically significant ( P<0.05). No marked changes were found in other blood biochemical indices. The time-course trajectories diagram of the urinary 1H NMR revealed the urinary metabolic profiles in all rats after dosing initially deviated from and subsequently returned to the levels of the control group. The principle components analysis (PCA) of 1H NMR at different time periods showed there was no significant difference in the rat urinary metabolic profiles among the 5 groups before dosing. The metabolic profiles in the drug-exposed groups could be distinguished from those in the control group, and the metabolic profile in the high-dose Lianbizhi B group deviated farthest from those in the control group 0-6 hours after dosing. Meanwhile, the trimethylamine(δ2.90)and dimethylglycine(δ2.94)levels increased and the citric acid (δ2.54,δ2.66)and α-ketoglutarate(δ2.46,δ3.02)levels decreased in the drugexposed groups compared with the control group. The metabolic profiles in the drug-exposed groups could be distinguished from those in the control group 7-12 hours after dosing . Compared with the control group, citric acid and α-ketoglutarate in the drug-exposed groups decreased and the TMA and DMG levels in the high- and low-dose Lianbizhi A groups and high-dose Lianbizhi B group increased. The metabolic profiles in the drugexposed groups could not distinguished from those in the control group within 13-48 hours after dosing and the metabolic profiles in the drug-exposed groups gradually returned to the levels of the control group. Conclusion:There is a correlation between the contents of other related substance in the Lianbizhi injection and the changes in the levels of rat urine endogenous metabolites. And the decrease in the levels of citric acid and α-ketoglutarate as well as the increase in the levels of trimethylamine and dimethylglycine suggest that the mechanism of renal damage caused by Lianbizhi injection may be related to its effects affecting the energy metabolism of mitochondria and osmotic pressure in renal medulla.
  • Chen Xiaoli, Zhang Rui, Liang Yan, Yang Zhen, Du Shuzhang
    Adverse Drug Reactions Journal. 2022, 24(4): 203-205. https://doi.org/10.3760/cma.j.cn114015-20210609-00658
    A 53-year-old male patient with small intestinal stromal tumor received imatinib 400-mg orally once daily after surgery. One month later, the patient developed eosinophilia, but it was not treated. Imatinib was continued. Four months later, edema and pain appeared in the hands, feet, and abdomen, which gradually spread to the whole body; ulcers appeared in part skin of the chest and back, and multiple maculopapular and ulcers were scattered throughout the whole body, accompanied by ulceration, exudation, itching, and pain. Eosinophil count was 2.7×109/L. Combined with the results of bone marrow aspiration and skin biopsy, it was diagnosed as eosinophilia and drug-induced rash, which were considered to be caused by imatinib. Clinical pharmacists participated in multidisciplinary consultation, analyzed the relationship between the adverse reactions and the drugs, and recommended stopping the drug, monitoring the blood concentration of imatinib for subsequent use, and adjusting its dosage. Doctors suspended imatinib treatment, and glucocorticoids and antihistamines were given. Then the patient′s rash was improved, and imatinib was continued at a reduced dose.
  • 调查研究
    Nie Yingjuan;Qian Yuanyu;Ren Suqin;Yang Xiaoqiu;Guo Daihong;Meng Qingyi
    . 2003, 5(6): 377-380.
    Objective: To investigate the situation of antihypertensive drugs' use and their adverse effects for elderly outpatients. Method: Information of antihypertensive drugs' use and the resulting adverse effects in 955 elderly cases with primary hypertension in outpatient department was collected by questionnaire visit and physical examination. Results: The most common drugs, which the patients would use to decrease blood pressure, were nifedipine delayed-release tablet(69.8%), nifedipine(30.8%) and metoprolol(27.5%), and then followed by indapamide, enalapril, terazosin, benazepril and captopril. Only nearly half of patients' blood pressure were under control in normal range (systolic pressure <140mmHg, dialectic pressure <90mmHg). The most common adverse effects were lower limb edema for calcium antagonists, hypokalemia for diuretics, cough for ACEI (angiotensin-converting enzyme inhibitors), bradycardia for βreceptor blockers and postural hypotension for αreceptor blockers. Conclusion: Antihypertensive drugs were not satisfactory for control of blood pressure and the adverse reactions were common in elderly outpatients.
  • 病例报告
    Huang JinaZhou MinaLiu JingbFang KunWang ZhidongbZhu LingbQiao AizhenbZhu Daqiang
    . 2010, 12(3): 201-4.
    A 21yearold man received combined chemotherapy with methotrexate 3.0 g, ifosfamide 2.0 g, gemcitabine 1.0 g, vinorelbine 20 mg, bortezomib 2.05 mg, Lasparaginase 10 000 U and prednisone 100 mg before undergoing transplantation of bone marrow stem cells denoted by his mother. Twentyfour hours later, he developed oliguria. His SCr, BUN, and uric acid levels were 246 μmol/L, 16.3 mmol/L, and 497 mmol/L, respectively. Thirtysix hours later, his blood methotrexate concentration was 25 μmol/L. Ultrasound examination revealed a slightly heterogeneous distribution in the renal density and a 2.1 cm x 2.3 cm echofree area in the right upper pole of kidney. Acute renal damage was diagnosed. The patient received treatments including calcium folinated 200 mg/3 h, adequate dehydration, alkalization of urine, and hemodialysis. The blood methotrexate concentration decreased, and his SCr and BUN levels returned to normal. Analysis of methylenetetrahydrofolate reductase C677T genotype in his mother’s peripheral blood lymphocytes, the patient’s peripheral blood lymphocytes and oral epithelial cells revealed that C:T was 1:1,1:1 and 1:1.5 respectively. Therefore, it suggested that the renal damage might be link to genotype.
  • 病例报告
    Qiu Changa;Jiang Fanb;Kuang Ruyic
    . 2010, 12(4): 286-3.
    Three patients with insomnia developed sleep behavior disorders after administration of zolpidem. Patient 1, a 56yearold woman, fell asleep after taking zolpidem 10 mg. One hour later, she walked into kitchen, opened the door of refrigerator, and then ate the food. Thirty minutes later, she went to bed voluntarily. The next day, the patient had no memory of that event. The similar conditions did not recur after zolpidem was decreased to 5 mg. Patient 2, a 23yearold woman, went to sleep after administration of zolpidem 10 mg. About two hours later, her classmate received one short message from the patient’s mobile phone. The second day, she had no memory of that event. The abovementioned symptoms did not recur after zolpidem discontinuation. Patient 3, a 28yearold woman, fell asleep after receiving zolpidem 15 mg. Ten minutes later, the patient experienced soliloquy and cannot recognize her roommate. The next day, she had no memory of the event. The abnormal behavior was not recur after zolpidem discontinuation.
  • Xue Hui, Ye Zhen, Wei Jilin, Lyu Xin, Zhu Shuqin, Deng Xu, Li Ying, Chen Chunguang, Cheng Cheng
    Adverse Drug Reactions Journal. 2021, 23(3): 152-153. https://doi.org/10.3760/cma.j.cn114015-20200820-00897
    A 66-year-old male patient with type 2 diabetes mellitus was treated with oral dapagliflozin (10-mg once daily) and pioglitazone hydrochloride and metformin hydrochloride (515-mg twice daily) regularly for more than 5 months and no adverse reactions occurred. Pioglitazone hydrochloride and metformin hydrochloride was changed to acarbose capsules (50-mg thrice daily orally) by himself. Three days later, the patient developed generalized skin itching with fever (at high temperature up to 41.0-℃), followed by pustules in the size of soybean to broad beans scattering on the whole body. Then acarbose capsules were stopped immediately. After consultation with dermatologists, acute generalized exathematous pustulosis was diagnosed. The patient was treated with dexamethasone for anti-allergy, insulin for management blood sugar, and cefoxitin for anti-infection. On the 4th day after discontinuation of acarbose capsules, the patient′s rash was improved and scab formed at the ulceration site; on the 9th day, the rash subsided.
  • 综述
    Wang Tao;Ye Qinong;Jiang Zefei
    . 2014, 16(5): 290-4.
    Endocrine therapy is an important treatment method for patients after breast cancer surgery. At the present, selective estrogen receptor modulator (such as tamoxifen) and aromatase inhibitors (such as anastrozole, letrozole, and exemestane) are main treatment drugs for patients after breast cancer surgery. The patients receiving adjuvant endocrine therapy need usually about 5 years and some patients need 10 years. The adverse reactions induced by tamoxifen were symptoms related to gynecology and cardiovascular system. The treatment measures include regular detection of the patients′ endometrium, pressure, and blood lipid, etc. and symptomatic treatments. The adverse reactions induced by aromatase inhibitors are as follows. (1) Adverse reactions related to bone. The treatment measures are supplement of vitamin D and calcium, and bisphosphonates maybe given. (2) Joint and muscle symptoms. The patients with mild symptoms are given vitamin D, calcium, and appropriate physical exercise. The patients in marked symptoms are given non steroidal anti-inflammatory drugs or the treatment drugs are stopped for 3-4 weeks. (3) Adverse reactions in cardiovascular system. The patients are given symptomatic treatments.
  • 调查研究
    Ma Jianlia;Ren Hongye;Liang Shulib
    . 2008, 10(4): 0-0.

    Objective: To analyze the related risk factors for drug-induced epileptiform seizures. Methods: The data of 148 patients with drug-induced epileptiform seizures were collected from CNKI and CMB between 1997 and 2007. The risk factors for drug-induced epileptiform seizures were analyzed retrospectively, including age, sex, and primary diseases of patients; causative drugs, dosage, and drug combination; type, onset time, duration, and prognosis of seizures. Results: Of the 148 patients, 82 were men, 66 were women. Their average age was (40.16±24.08) years. Fifteen patients of them had history of epilepsy .The first three kinds of drugs that may induce epileptiform seizures were antimicrobial drugs, drugs acting on the central nervous system, and anesthetics. Eighty-two cases (55.41%) of epileptiform seizure were caused by antimicrobial drugs, and quinolones accounted for 39 of 82 cases. Thirtyfour cases (22.97%) were caused by drugs acting on the central nervous system, and antipsychotic accounted for 20 of 34 cases. Eight cases (5.41%) caused by anesthetics, and ketamine accounted for 6 of 8 cases. The most common type of epileptiform seizures was generalized tonicclonic seizure (120 cases, 81.08%), followed by complex partial seizure (15 cases, 10.14%). The patients < 19 years of age were 32 cases (21.6%), and the patients ≥60 years of age were 52 cases (35.14%). The patients receiving drug overdose were 21 cases (14.19%). Of 45 patients receiving drug combination, 10 patients developed epileptiform seizures. The time of seizure onset was 3 minutes to 6 months after the first administration of the drug, lasting from 4 seconds to 20 minutes. After drug withdrawal or symptomatic therapy, 147 patients with epileptiform seizures improved or recovered, and one patient died from pulmonary infections and circulatory failure. Conclusion: The risk factors for drug-induced factors include the effects of drugs on the central nervous system, patient's age (older or younger age), history of epilepsy, primary diseases, overdose, and drug combination.

  • 安全用药
    . 2004, 6(2): 101-105.
    本文对1998年-2002年8月有关文献记载的卡托普利不良反应508例,按系统分类统计,并作综合报道。结果表明,其不良反应几乎可在各系统出现,其中以剧烈干咳、味觉异常、蛋白尿、血尿和低血压等最常见;能危及生命的有:急性血小板减少症、高血钾、严重心律失常和肾功能衰竭。
  • ADE简报
    . 2001, 3(1): 27-27.
  • Qiu Zhihong, Ma Yinling, He Lien, Dong Zhanjun
    . 2017, 19(2): 147-148.
    A 61-year-old female patient with stomach discomfort received omeprazole enteric coated tablet 40 mg once daily. On day 3 of administration of omeprazole, she presented sporadic  erythema and stopped the medicine by herself. Three days after drug withdrawal, her symptom of erythema improved. She received omeprazole enteric coated tablet at the previous dosage again. Two days after taking medicine again, the patient developed rash all over her body, severe diarrhea and vomiting, acute renal injury and allergic shock in succession. She was diagnosed as severe allergic reaction due to omeprazole. The patient received the treatments of antianaphylaxis, maintaining the function of circulatory system, fluid infusion, and continuous veno venous hemodiafiltration. But the therapeutic effect was poor. The patient died on the second day after giving up the treatment which decided by her family members.
  • Mei Kangkang, Luo Zhihong, Wang Jian, Qu Lijun
    . 2016, 18(2): 121.
    Mercaptopurine is used to treat children with acute lymphoblastic leukemia. Mercaptopurine can cause bone marrow suppression and liver toxicity, threatening the lives of children, resulting in interruption or discontinuation of the chemotherapy, increasing the risk of disease recurrence. The mercaptopurine dosage regimens should be adjusted according to drug metabolizing enzyme genotypes, detection of intra-erythrocytic metabolic products, and creating a physical model. Individualized administration should be adopted in order to improve the efficacy and safety of mercaptopurine.
  • Chen Yi, Ying Yingqiu, Li Shanshan, Yang Li, Zhai Suodi
    Adverse Drug Reactions Journal. 2020, 22(11): 662-664. https://doi.org/10.3760/cma.j.cn114015-20200708-00751
    A 74-year-old male patient underwent posterior lumbar decompression, fusion, and internal fixation under general anesthesia for lumbar spinal stenosis. Sevoflurane (1.5%), propofol, sufentanil, etomidate, and cisatracurium were used for anesthesia, followed by dexamethasone for allergy prevention, cefuroxime for infection prevention, and hydroxyethyl starch for hemodynamic stabilization. Inhalation of sevoflurane (1.5%) and introvenous pumping of remifentanil 300-μg/h and phenylephrine 0.4-mg/h were given for anesthesia maintenance during the operation. The operation process went smoothly and no anaphylaxis occurred within 4 hours. At the end of the operation, vancomycin powder 1 g was given topically at the surgical site and intravenous injection of flurbiprofen axetil 50-mg was given 15-minutes later. Twenty minutes after the medication, the patient′s pulse oxygen saturation was not detectable and the blood pressure fell to 45/20-mmHg. Severe anaphylaxis was diagnosed. The central vein was immediately switched on, and intravenous injection of epinephrine and norepinephrine and intermittently intravenous injection of norepinephrine were given. Ten minutes later, the pulse oxygen saturation returned to 1.00 and 15-minutes later, the blood pressure became stable. At the same time, 2 000-ml of sodium lactate Ringer′s injection was given. The patient was in stable condition 5 hours later and was transferred out of the operating room. The severe anaphylaxis in this patient was considered to be related to vancomycin and flurbiprofen axetil.
  • 病例报告
    Song Zhihui;Zhao Huanyu
    . 2014, 16(1): 54-2.

    A 78-year-old woman with type 2 diabetes received an IV infusion of omeprazole sodium injection 20 mg and levofloxacin lactate and sodium chloride injection 0.3 g successively for nausea, vomiting, acidic regurgitation, and diarrhea for 3 days. The patient developed hyperhidrosis, palpitation, pale, and unconsciousness 10 minutes after IV infusion of levofloxacin lactate and sodium chloride infusion. Laboratory examination showed blood glucose was 3.0 mmol/L. Levofloxacin lactate and sodium chloride infusion was discontinued temporarily. She was given an IV infusion of glucose saline 500 ml, candy and bread. Five minutes later, her symptoms were mitigated. An IV infusion of levofloxacin lactate and sodium chloride infusion was given again. The symptoms mentioned above recurred 5 minutes later. Laboratory examination showed blood glucose was 1.9 mmol/L. Levofloxacin lactate and sodium chloride infusion was withdrawn immediately, and an IV bolus of 50% glucose 20 ml and IV infusion of 5% glucose 500 ml were given successively. Ten minutes later, her hypoglycemia symptoms disappeared, and the blood glucose increased to 9.6 mmol/L.

  • 病例报告
    Yang Wei;Gu Jian
    . 2010, 12(6): 426-3.
    A 14yearold girl with lymphoma stage Ⅳ was hospitalized and received her sixteenth course of chemotherapy. On admission, laboratory testing revealed the following levels: WBC count 5.58×109/L, Hb 88 g/L, PLT count 143×109/L, SCr 42 μmol/L, ALT 38 U/L. Her heart, liver and renal functions were almost normal. Methotrexate was given intravenously according to the following protocol: a total methotrexate dose of 4 g, one third of the total dose within 0.5 hour, and then the remaining dose within 23.5 hours. Meanwhile, dexmethasone 5 mg, cytarabine 40 mg, and methotrexate 12.5 mg were administered intrathecally, and IV vincristine 1.8 mg was given. On day 2 of chemotherapy,the girl developed fever, vomiting, diarrhea and edema in her lower limbs. On day 3, laboratory investigations showed the following levels: WBC count 2.49×109/L,PLT count 24×109/L,Hb 58.0 g/L, potassium 2.74 mmol/L,SCr 179 μmol/l,CK 1 089 U/L. Her blood methotrexate concentrations 24 and 42 hours after chemotherapy completion were 168.0 and 65.0 μmol/L, respectively. During blood purification period, her blood methotrexate concentrations were 36.5 μmol/L (66 h), 29.4 μmol/L (73 h), 22.1 μmol/L (77 h) and 16.0 μmol/L (90 h). On day 5 of chemotherapy, her urine volume decreased to 460 mL, followed by anuria and convulsions. After receiving IV diazepam 5 mg, her convulsions was relieved, but she still had agitation.
  • 病例报告
    Feng Jinguang①;Shi Wei②
    . 2007, 9(3): 203-204.
    An 82-year-old man with type Ⅱ diabetes mellitus was treated with glipizide 5mg thrice daily for 1-2 years. Later glipizide was stopped and his regimen was changed to acarbose 50mg thrice daily and then increased to 100 mg thrice daily for 3 months. He developed lethargy. Laboratory tests revealed the following values: blood glucose 2.1 mmol/L, ALT 62 U/L, AST 55 U/L. The patient was given glucose 50% and glucose 10% intravenously. Two hours later, he slowly began to revive. Acarbose was discontinued. The patient received compound α-ketoacid tablets and silibinin. Three months later, laboratory tests showed the ollowing values: fasting blood glucose 6.2 mmol/L, ALT 30 U/L, AST 26 U/L.
  • 调查研究
    Che Ning;Tan Ling;Fu Dexing
    . 2005, 7(3): 178-181.
    Objective:To review the occurrence of drug-induced eye disorders and analyse their relation with the causative drugs and the routes of administration. Methods: The papers on drug-induced eye disorders in 28 domestic medical journals from 1997 to 2003 were collected and analysed. Results:There were 156 cases of drug-induced eye disorders caused by 42 drugs. The clinical findings included glaucoma, visual deterioration, loss of sight, disorders in conjunctiva and retina, and the causative drugs were mostly antimicrobials, hormones, and antineoplastics. Conclusion: When administered by eye, the drugs caused adverse reactions due to misuse of medicines, inappropriate manipulation and medication errors during or after operations. As for other routes of administration, eye damage occurs mostly at regular doses.
  • 病例报告
    . 2002, 4(2): 120-120.
  • 安全合理用药
    Yu Aihe
    . 2007, 9(3): 177-181.
    Atypical antidepressants are safer than tricylic antidepressants, but their overdose use may cause severe life-threatening adverse reactions. This article provides adverse reaction profiles of four atypical antidepressants including mitrazapine, venlafaxine, amfebutamone, and Hypericum perforatum extract, and their management.
  • 调查研究
    Ma Suwen;Li Kuncheng
    . 2007, 9(3): 169-171.
    Objective: To investigate the effects of Ⅳ dexamethasone on the incidence and severity of allergic reactions induced by iopromide used for contrast-enhanced CT scan. Methods: During the period from January 2005 to February 2006, 4 114 patients receiving Ⅳ iopromide 90~100 ml for contrast-enhanced CT scan were collected. The patients were divided into the following two groups: experimental group (2 363 cases) and control group (1 751 cases). The patients in the experimental group were administered with Ⅳ dexamethasone 5 mg 20 min before administration of iopromide. The patients in the control group were administered iopromide alone. The incidence and severity of allergic reactions in the two groups were observed and analyzed. Results: Among the experimental and control groups, there were 15 (0.6%) and 35 (2.0%) cases with allergic reaction, respectively. The difference of incidence of allergic reaction between them were statistically significant(P<0.05). Mild and moderate allergic reactions in the experimental group were 9 and 6 cases, and in the control group were 19 and 16 cases, respectively. There was no significant difference in the severity of allergic reactions between the two groups(P>0.05). Conclusion: Intravenous injection of dexamethasone before contrast-enhanced CT scan could decrease the incidence of allergic reactions induced by iopromide. But it does not influence on theseverity of allergic reactions.
  • Gao Lingyan, Gao Lihua, Liu Hua
    Adverse Drug Reactions Journal. 2024, 26(5): 315-317. https://doi.org/10.3760/cma.j.cn114015-20231115-00807
    A 31-year-old woman received semaglutide injection subcutaneously for weight loss. Three months later, the electrocardiogram showed sinus tachycardia, and the laboratory tests showed triiodothyronine (T3) 2.75-nmol/L, thyroxine (T4) 199.86-nmol/L, free triiodothyronine (FT3) 11.31-pmol/L, free thyroxine (FT4) 46.63-pmol/L, thyroid-stimulating hormone (TSH)<0.005 mU/L. Considering the sinus tachycardia and hyperthyroidism caused by semaglutide injection, the drug was discontinued, and methimazole 10-mg orally, twice daily and metoprolol 25-mg orally twice daily were given. After treatment for more than 1 month, the electrocardiogram of the patient was normal, and the thyroid function examination showed T3-1.79-nmol/L, T4-127.33-nmol/L, FT3-4.94-pmol/L, FT4-15.87-pmol/L, and TSH<0.005 mU/L. However, there were elevated liver enzymes, showing alanine aminotransferase 327-U/L, aspartate aminotransferase 148-U/L, and γ-glutamyl transpeptidase 123.4-U/L. Then, methimazole and metoprolol were stopped, and silibinin 140-mg orally thrice daily combined with bicyclol 50-mg thrice daily were given. More than 1 month after treatments, the patient′s thyroid function and liver function were normal, and silibinin and bicyclol were stopped. After that, the thyroid function, liver function and electrocardiogram were all normal in repeated examinations.
  • Ophthalmic Pharmacy Professional Committee of Peking Safety Medicine Foundation, Medicine Therapy Management Working Committee of Chinese Pharmacists Association, Clinical Pharmacy Branch of China International Exchange and Promotive Association for Medical and Health Care
    Adverse Drug Reactions Journal. 2025, 27(2): 65-78. https://doi.org/10.3760/cma.j.cn114015-20241216-00206
    Intravitreal injection (IVI) is an administration technique that uses a syringe to deliver drugs into the vitreous cavity. Currently, multiple IVI drugs have been successively approved for the treatment of various fundus diseases, including antivascular endothelial growth factor drugs, intravitreal sustained- release glucocorticoid drugs, and so on. Meanwhile, there are many injection drugs off label used by IVI. At present, there is a lack of pharmaceutical care guidance documents for the clinical application of IVI drugs. To promote the development of pharmaceutical care for IVI drugs, Ophthalmic Pharmacy Professional Committee of Peking Safety Medicine Foundation, Medicine Therapy Management Working Committee of Chinese Pharmacists Association, and Clinical Pharmacy Branch of China International Exchange and Promotive Association for Medical and Health Care organized experts to formulate this consensus based on clinical practice experience and with reference to relevant domestic and foreign research data, guidelines, and literature. This consensus combs the characteristics of clinical application of IVI drugs, relevant pharmaceutical services before, during and after injection, and forms 26 recommendations for 5 clinical issues, which can be used by medical institutions at all levels to carry out pharmaceutical services of IVI drugs. The users are medical staff in medical institutions at all levels (including pharmacists, physicians, nurses, and other relevant staff), and the target population for application is mainly patients using IVI drugs.
  • 安全用药
    . 2006, 8(4): 272-276.
    磷是人体内的重要元素,具有许多生理功能。磷代谢异常时,出现高磷血症和低磷血症。本文对″药物性高磷血症″的病因、临床表现及治疗作一简要概述,提醒临床在应用含磷药物时,要密切观察患者体内血磷的变化,减少和避免高磷血症的发生,保障用药安全有效。
  • 临床论著
    Qiu Rong;Fu Yan;Zhao Xingshan;Gao Haiqing;Liu Kunshen;Zhao Tongbing;Li Shuren;Ren Ziwen;Hua Qi
    . 2009, 11(5): 315-6.
    Objective: To compare the differences in edema and other adverse reactions of levamlodipine versus amlodipine, nifedipine, and felodipine. Methods:A multicentre, randomized, open-label, self-control study was performed. Form June 2008 to March 2009, 83 patients with mild-to-moderate primary hypertension, who experienced edema after receiving amlodipine (38 cases), nifedipine (30 cases), and felodipine (15 cases), were enrolled in the study. All abovementioned medications were discontinued one week, then levamlodipine 2.5~5.0mg/d for 8 weeks was given. The observations and comparisons before and after levamlodipine treatment included: the severity of edema and other adverse reactions; the values of blood pressure, heart rate, and body weight; the results of routine blood tests and biochemical blood tests. Results:The severity of pitting edema at insteps was (2.69±1.21)mm one week before starting levamlodipine treatment and (1.63±1.35)mm and (1.74±1.90)mm after 4 and 8 weeks of treatment, respectively; the difference between one week before starting treatment and after 4 weeks of treatment was statistically significant (P< 0.05). The calf circumference 1 and calf circumference 2 were respectively (37.73±2.48)cm and (35.41±2.85)cm one week before starting treatment and (37.18±2.50)cm and (34.73±2.96)cm after 8 weeks of treatment; the differences were statistically significant (P< 0.05, P< 0.01). The ankle circumference were (23.47±2.19)cm 1 week before starting treatment and (22.83±2.09)cm after 8 weeks of treatment; the difference was statistically significant (P< 0.01). The incidence of facial flushing was 15.7% one week before starting treatment and 7.3%, 2.5%, and 1.3% after 2, 4, and 8 weeks of treatment, respectively. The incidence of dizziness was 4.8% one week before starting treatment and 2.4%, 0, and 1.3% after 2, 4, and 8 weeks of treatment. The blood pressure was (140.59±12.92)/(86.76±9.63) mm Hg before starting treatment and (125.76±8.53)/(77.84±6.46)mm Hg after 8 weeks of treatment, and heart rate was (70.93±8.30)beats/min before starting treatment and (69.17±6.52) beats/min after 8 weeks of treatment, respectively; the differences were statistically significant (P< 0.001, P< 0.05). Red blood cell count and hemoglobin level were (4.45±0.60)×1012/L and (131.22±14.95)g/L before starting treatment and (4.66±0.62)×1012/L and (138.09±17.46)g/L after 8 weeks of treatment, respectively; the differences were statistically significant (P< 0.05, P<0.01). No statistically significant difference in the indices of body weight, routine blood tests, and biochemical blood tests was found between before treatment and after treatment(all P> 0.05). Conclusion:levamlodipine is a relatively safe agent for treatment of hypertension, compared with amlodipine, nifedipine, and felodipine.
  • 调查研究
    Kou Xiujing;Yang Xiaochen;Zhang Liming;Zheng Qiang
    . 2008, 10(2): 94-6.

    Objective: To analyze the risk factors of myelopathy induced by intrathecal methotrexate. Methods: Thirtysix patients with intrathecal methotrexateinduced myelopathy were collected from English literature between 1969 and 2007. The age and original diseases of the patients, the dosage and frequency of intrathecal methotrexate, combined drugs, myelopathy and its outcome were analyzed. Results: Thirty (83.3%) patients age was < 18 years. Thirtyfour cases stated the sigle dose of methotrexate, and 28 (77.8%) of them received methotrexate ≤15 mg, the others received methotrexate < 50 mg. Twentyseven patients received more than 5 injections. Paraplegia after first injection occurred in 2 cases. Eleven patients received methotrexate alone, and 25 patients were given methotrexate combined with cytarabine and/or dexamethasone. The time of myelopathy onset in 11 patients was within 24 hours after intrathecal injection. Flaccid paralysis involving the lower extremities or the extremities occurred in 35 patients. After treatment of highdose methylprednisolone and folic acid, 21 patients motor and sensory functions of the extremities partly or fully recovered. And 11(30.6%) patients died. Conclusion: Intrathecal methotrexateinduced myelopathy might be linked to more frequent injection and higher total dosage of methotrexate, and multiple concomitant medications.

  • 病例报告
    . 2006, 8(6): 455-455.
  • 调查研究
    Li Zili;Shi Shushan;Jiang Jinwe;Wang Renrun;Li Fang
    . 1999, 1(1): 33-35.
    Objective: To analyse ostconecrosis induced by glucocorticoids in the clinical practice, and provide basis for early prevention , diagnosis and treatment. Methods: 128 cases of osteonecrosis were induced by glucocorticoids treatment during the 10 years between 1986 and 1995, and the aspects of age, sex, course of diseases, primary diseases, dose of glucocorticoids, and early clinical manifestation were analysed. Results: The incidence of osteonecrosis was lower in doses normally than in doses abnormally, and the incidence was higher in long treatment course than in short treatment course. Conclusion: Rational use of glucocorticoids and early prevention can reduce the incidence of osteonecrosis.
  • 中毒救治
    . 2007, 9(2): 121-124.
    解毒药物在急性中毒的救治中发挥重要作用,但其在救治过程中引起的不良反应容易被忽视。本文对常用解毒药物的不良反应分别进行概述,以助于临床安全应用。
  • 病例报告
    Xie Yiru①;Chen Ruiqing②;Huang Chuzhu①
    . 2007, 9(5): 366-367.
    A 39-year-old female patients with reflux esophagitis and antral chronic gastritis was administered with omeprazole enteric coated tablets 20 mg twice daily,domperidone tablets,and hydrotalcite chewable tablets.After two weeks treatment,she developed drowsiness,fatigue,anorexia,and low fever.Her count of WBC decreased from 6.3×109/L to 3.6×109/L.Omeprazole was replaced with ranitidine 150 mg twice daily.Domperidone and hydrotalcite therapy was continued,and leueogen 20 mg thrice daily was added to her regimen.Three days later,her count of WBC increased to 4.2×109/L.At follow-up,her blood cell count restored to normal limits.
  • 安全信息
    . 2010, 12(3): 225-1.
  • Chen Yan, Yang Shenshen, Wang Zimin, Wang Weihua
    Adverse Drug Reactions Journal. 2023, 25(6): 379-381. https://doi.org/10.3760/cma.j.cn114015-20220613-00523
    A 98-year-old male patient received cefoperazone sodium and sulbactam sodium and ambroxol etc. due to pulmonary infection. Before treatments, the patient′s coagulation function was basically normal, and the platelet count was within the reference range. Due to poor anti-infection effect, cefoperazone sodium and sulbactam sodium was changed to voriconazole combined with piperacillin sodium and tazobactam sodium 13 days later, which was adjusted to voriconazole, meropenem and linezolid glucose injection 7 days later. Three days after linezolid administration, the patient′s temperature was 39.3-℃, and scattered dark red petechiae appeared on his both hands, upper limbs, shoulders and back, with some appearing as patchy ecchymosis, without tenderness pain and fading when pressing. Laboratory tests showed that prothrombin time was 18.4-s, international normalized ratio was 1.50, activated partial thromboplastin time was 53.6-s, fibrinogen was 5.11-g/L, and plasma D-dimer was 4.27-mg/L. It was considered to be allergic purpura, which might be related to linezolid glucose injection. The drug was stopped and replaced by tigecycline, and the treatment such as anti-allergy, fluid replacement, and plasma infusion were given. Eleven days later, the patient′s skin petechiae and ecchymosis disappeared. Laboratory tests showed prothrombin time 16.2-s, international normalized ratio 1.28, activated partial thromboplastin time 35.6-s, fibrinogen 2.62-g/L, and plasma D-dimer 2.48-mg/L.
  • 安全用药
    Yu Yaping
    . 2009, 11(6): 410-6.
    An increased risk of venous thromboembolism (VTE) may occur in patients with multiple myeloma( the incidence is about 3%~10%), the risk could further increase during treatment with thalidomide or lenalidomide. The risk factors for VTE are age, obesity, history of venous thromboembolism, central venous catheter, complications (infections, diabetes mellitus, cardiovascular disease, etc.), surgery, hereditary thrombophilia, combined therapy with highdose dexamethasone, doxorubicin, erythropoietin, or multidrug chemotherapy. Generally, the time to VTE onset is within 6 months after treatment. A study shows that incidence of VTE may decrease after receiving prophylaxis of venous thrombosis during treatment with thalidomide or lenalidomide. VTE may be prevented as follows: lowrisk patients receive aspirin; highrisk patients receive low molecular weight heparin(LMWH) or an adequate dosage of warfarin; the patients receiving highdose dexamethasone or doxorubicin or multidrug chemotherapy should be administered LMWH or an adequate dosage of warfarin for 4~6 months in general.
  • 实验研究
    Luo Xia;Wang Qing;Zhou Lian;Dong Yan;Jiang Yiping
    . 2010, 12(3): 160-6.

    ABSTRACTObjective: To observe the effects of different concentrations of Tween-80 solutions and injections of Chinese herbal medicine with different contents of Tween-80 on degranulation of RBL-2H3 cells in order to explore the relationship between Tween-80 and anaphylaxis caused by injections of Chinese herbal medicine. Methods:RBL-2H3 cells were cultured in vitro and the different concentrations (40, 20, 10, 2, 1, 0.2, 0.1, 0.05mg/mL) of Tween80 solutions were added into the supernatants and then stained with neutral red. The degranulated cells in the different concentrations of Tween-80 solutions and the control groups were counted, respectively; the percentage of degranulated cells were calculated, and the amount of β-hexosaminidase and histamine release from the cells in the supernatants were measured. The contents of Tween-80 in the chuanghuning and xiangdan injections were determined, and the 50% concentration of inhibition (IC50) of the 2 injections to the RBL-2H3 cells and histamine release from the cells in the supernatants in the 2 injection groups were measured. Results:The experiment of neutral red staining showed degranulation of RBL-2H3 cells, manifested as enlarged mast cells with vacuoles. The percentage of degranulation of RBL-2H3 cells in the 40, 20, 10, 2, 1, 0.2, 0.1 mg/mL Tween-80 solution groups and the RPMI 1640 control group were (57.38±0.47), (32.54±2.33), (21.74±0.72), (16.96±0.26), (11.40±1.70), (9.71±0.26), (7.22±0.15), and (1.51±1.39)%, respectively. There were significant differences between the two groups (P<0.05,P<0.01). The percentage of βhexosaminidase release from RBL2H3 cells in the 40, 20, 2, 1, 0.2 mg/mL Tween-80 solution groups and the RPMI 1640 control group were (52.44±1.53), (18.91±0.77), (7.50±1.82), (6.65±0.20), (6.15±0.27), and (0.35±0.06)%, respectively. There were significant differences between the two groups (P<0.05, P<0.01). The different concentrations of Tween-80 solutions induced different levels of histamine release. There was a linear relationship between the percentage of degranulation, β-hexosaminidase release, histamine release from RBL-2H3 cells and the concentration (20-0.1mg/mL) of Tween-80 solutions (r=0.986 2, r=0.984 9, r=0.974 0). The contents of Tween-80 in the chuanghuning and xiangdan injections were (0.086±0.004) and (0.070±0.007) μg/mL, respectively. The IC50 of the two injections to RBL-2H3 cells were (57.4±1.2) and (1.0±0.2) μL/mL, respectively. The levels of histamine release in the chuanghuning and xiangdan injection groups were (2.39±0.01) and (1.87±0.00) ng/mL, respectively. Conclusion:Tween-80 can induce RBL-2H3 cells to release inflammatory mediators; the levels of histamine release from the RBL2H3 cells are related to the contents of Tween-80 in the injections of Chinese herbal medicine;Tween-80 contained in injections of Chinese herbal medicine may be related to the anaphylaxis.

  • 安全用药
    . 2005, 7(4): 267-271.
    肾功能不全时药物的肾脏排泄速度减慢或清除量降低,主要经肾脏排泄的药物及其活性代谢产物易在体内蓄积,使药物的血浆半衰期延长,导致药物的毒副作用发生率明显增高。其机制主要涉及体内毒素和代谢产物蓄积、水电解质及酸碱平衡失调、药物的血浆蛋白结合率变化等因素影响了药物的体内分布容积和代谢过程,并干扰了肝脏代谢酶的功能。肾功能减退时应严格掌握用药原则,可根据肾功能损害程度粗略估计药物剂量或根据药物剂量调节因子方程式个体化给药。
  • 调查研究
    Su Wanzeng;Wang Qing;Wang Minru;Wang Xinmei;Zhang Yongmei
    . 2003, 5(1): 8-11.
    Objective: To analyse the clinical manifestations and management of drug-induced adverse reactions. Method: The inpatients of 1989-2001 were retrospected, who developed unwanted reactions during treatment courses. Results.- In 127 cases of adverse reactions cardiovascular drug-induced ones accounted for 77 cases (60.63%),followed by hormones (22 cases, 17.32%), antibiotics ( [leases, 8.66%), antineoplastic drugs (3 cases, 2.36%) and others (Meases, 11.02%). Among them were 48 cases of severe reactions (37.79%), resulting in 6 deaths (4.72%) . Serious reactions included anaphylaxis, laryngeal edema, ventricular tachycardia, angioneurotic edema and acute renal failure. Conclusion: Adverse reactions can be associated with many drugs, mostly with cardiovascular drugs.
  • 病例报告
    . 2000, 2(4): 244-244.
  • ADR监测
    . 2001, 3(2): 100-103.
  • 病例报告
    . 2002, 4(1): 50-50.
  • 病例报告
    Ma Jin;Zhong Yong
    . 2009, 11(1): 62-2.
    Two patients developed corneal ulcer following use of tobramycindexamethasone eye drops.Patient 1, a 54yearsold man with neovascular glaucoma and central retinal vein occlusion in his right eye, underwent glaucoma valve in plantatim. Postoperatively, one drop of tobramycindexamethasone eye drops as instilled into his operated eye every one hour. On day 7, superficial oval ulcer with grey edema along its edge occurred in the temporal part of corneal limbus in his right eye. The ulcer depth was onethird of corneal thickness. Swab cultures were negative for bacteria and fungi. Corneal ulcer was considered to be tobramycindexamethasone eye dropsinduced. The eye drops were discontinued immediately, and recombinant bovine basic fibroblast growth factor eye drops, sodium carboxymethylcellulose eye drops, vitamin C tablets, and vitamin B2 tablets were given. Two days later, his corneal ulcer was complete healing.Patient 2, a 28yearsold woman with traumatic cataract and subluxation of lens in her left eye, underwent cataract extract and intraocular lens implanation in her left eye. After surgery, one drop of tobramycindexamethasone eye drops was instilled into her operated eye every one hour. On day 3, a beltlike ulcer with grey oedema along its edge occurred in temporal part of corneal limbus in her left eye. The ulcer depth was twothird of corneal thickness. Swab cultures were negative for bacteria and fungi. Tobramycindexamethasone eye drops were stopped as the drops were suspected as a causative factor for the corneal ulcer. Recombinant bovine basic fibroblast growth factor eye drops, sodium carboxymethylcellulose eye drops, vitamin C tablet, and vitamin B2 tablets were administrated. After 3 days, her corneal ulcer was complete healing.
  • 安全用药
    . 2003, 5(5): 313-317.
    本文对碘化造影剂引起的肾损害及其发生率、临床表现、发病机理、危险因素、预防措施以及治疗作了简要介绍。造影剂肾损害在有糖尿病或肾功能不全等高危因素的患者中发生率较高,而普通人群发生率低。只要注意患者的选择、合理使用造影剂、适当采取预防措施,可以防止肾损害的发生或减轻其危害性。
  • WHO信息
    . 2004, 6(2): 137-137.
  • 论著
    DU Hui;BAO Yong-bo
    . 2013, 15(3): 148-4.

    ObjectiveTo explore the occurrence and related factors of blood coagulation dysfunction due to cefoperazone sodium and sulbactam sodium in neonates.MethodsCase records of the neonates who developed blood coagulation dysfunction due to cefoperazone sodium and sulbactam sodium for injection (ADR group) in Zaozhuang Municipal Hospital of Shandong Province from May 2007 to April 2012 were collected and retrospectively analysed. The general situation, the situation of drug use, clinical symptoms, laboratory examinations [activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT), and fibrinogen (FIB)], and clinical outcomes of the neonates were recorded. The results of coagulation function tests of normal neonates for the control (the normal control group) were obtained from a literature. Related factors of adverse reactions were analysed in Logistic regression.ResultsThere were 36 neonates (19 males and 17 females) in the ADR group, which accounted for 4.7% of 768 neonates. There were 32 neonates (25 males and 7 females) in the control group. The values of APTT, PT, and TT in the ADR group were longer markedly than those in the control group [(50.3±14.4) s vs. (42.5±6.4) s,P<0.05; (16.2±3.9) s vs. (13.4±2.6) s, P<0.01; (21.2±4.5) s vs. (16.3±3.7) s,P<0.01]. The FIB level was lower markedly than that in the ontrol group [(1.7±0.4) g/L vs. (2.0±0.6) g/L, P<0.05]. Gestational age <34 weeks, weighing <2000 g, and birth asphyxia history were risk factors of blood coagulation dysfunction induced by sodium cefoperazone sodium and sulbactam. After the drug withdrawal, vitamin K1 and other supportive treatments were given, the blood coagulation function of 34 neonates (94.4%) returned to normal within 7 days and 2 neonates (5.6%) died of deterioration of their primary diseases.ConclusionThe incidence of neonates′blood coagulation dysfunction induced by sodium cefoperazone sodium and sulbactam is 4.7% and risk factors are preterm birth, low weight, and history of asphyxia.

  • Xia Peiyuan
    . 2017, 19(2): 81-83.
  • 论著
    Liu Chen;Wang Yuqin;Shen Qian;Li Xiaoling;Jiang Dechun;Li Xingwei
    . 2014, 16(6): 336-5.
    ObjectiveTo evaluate rationality of drug application in aged inpatients with brain infarction in Xuanwu Hospital of Capital Medical University. MethodsMedication records of ≥60 years old inpatients with brain infarction from January 1st, 2011 to December 31st in our hospital were collected. The patients′ general information was descriptively analyzed and drug utilization index (DUI), defined daily cost (DDC), and an average daily cost of each patient were calculated. Published guidelines in our country and abroad were searched and the therapeutic drugs used in aged inpatients with brain infarction in our hospital were compared with recommended drugs in Chinese guideline, and the rationality of drug use in our hospital was evaluated. ResultsData of a total of 430 patients were collected. Of them, 272 patients were male and 158 were female. The age of the patients was from 60 to 92 years and an average age was (71±7) years. The average number of diseases in each patient was 5.4. A total of 243 kinds of drugs were used during hospitalization and an average number of kinds of drugs in each patient was 17. A total of 8 guidelines related to brain infarction published in USA, Japan, China, South Africa, New Zealand, United Kindom, Europe, and Brazil were searched. There were 7 kinds of drugs in the above mentioned guidelines, including thrombolytic drugs, antiplatelet drugs, anticoagulation drugs, antifibrinolytic drugs, volume extending drugs, drugs for vasodilation, and neuroprotective drugs. The Chinese guideline recommended 3 kinds of drugs, including thrombolytic, antiplatelet, and antifibrinolytic drugs. Of them, 4 drugs in 2 kinds were used in our hospital, including alteplase (rt-PA), urinary kallidinogenase, aspirin, and clopidogrel and their DUI were 1.0, 1.2, 1.2, and 1.2, respectively. Thirteen kinds of neuroprotective drugs were used in aged inpatients with brain infarction in our hospital, whose cost accounted for 38.75% (1 782 343.6/4 599 576.7) of total medication cost, which was 17 times (1 782 343.6/103 779.7) the cost of recommended drugs in the Chinese guidelines. ConclusionsDrugs used in aged inpatients with brain infarction in our hospital are in accordance with recommended drugs in Chinese guidelines. However, neuroprotective drugs which are not recommended in Chinese guidelines are used excessively, which cost too much and should be standardized further.
  • Shen Changlong, Fu Shuangnan, Zhou Kun, Gong Man, Yu Li, He Tingting
    Adverse Drug Reactions Journal. 2020, 22(4): 268-269. https://doi.org/10.3760/cma.j.cn114015-20180813-00787
    A 52-year-old male patient received self-purchased Yinaoning tablets (益脑宁片) (3 tablets, trice daily) orally for health care. On day 18 of medication, the patient developed jaundiced skin and sclera and dark urine. On day 24, he developed fatigue and anorexia. Laboratory tests showed alanine aminotransferase (ALT) 1-132-U/L, aspartate aminotransferase (AST) 953-U/L, total bilirubin (TBil) 80.0-μmol/L, direct bilirubin (DBil) 73.4-μmol/L, alkaline phosphatase (ALP) 203-U/L, and gamma-glutamyltransferase (γ-GT) 155-U/L. Acute liver injury induced by Yinanning tablets was considered. Then the drug was discontinued and liver-protective therapy and drugs for anti-jaundice were given. On day 6 of drug withdrawal, the laboratory tests showed ALT 192-U/L, AST 158-U/L, TBil 51.0-μmol/L, DBil 39.9-μmol/L, ALP 178-U/L, and γ-GT 149-U/L, his appetite recovered, and the yellowish skin and sclera improved mar- kedly. On day 13 of drug withdrawal, his yellowish skin and sclera disappeared, and the laboratory tests showed ALT 56-U/L, AST 62-U/L, TBil 30.7-μmol/L, DBil 22.4-μmol/L, ALP 164-U/L, and γ-GT 142-U/L. At 6 months of follow-up, there were no abnormalities in his liver function.
  • Zhang Qingwen;Dong Yonghua
    Adverse Drug Reactions Journal. 2009, 11(6): 431-1.
    A 68yearold man with prostatic hyperplasia received an IV infusion of cefminox sodium 3.0 g in 0.9% sodium chloride 250 ml twice daily and an IV infusion of amoxicillin and clavulanate potassium 1.8 g in 0.9% sodium chloride 250 ml twice daily for prevention of infections for 5 days. On day 6, after infusion of 10 ml of cefminox sodium, the patient developed dizziness, nausea, chest distress, polyhidrosis, weak pulse, undetectable blood pressure. The infusion was stopped immediately. Oxygen inhalation, SC adrenaline, an IV push of dexamethasone, and an IV infusion of dopamine were given. Subsequently, his symptoms worsened and he presented with unconsciousness, deep coma without spontaneously breathing. Finally, the patient died despite resuscitation attempts.
  • 安全用药
    . 2004, 6(3): 166-169.
    为了解抗真菌药物伊曲康唑的不良反应,查阅国内外公开发行的医药期刊有关伊曲康唑不良反应的病例报道。伊曲康唑的主要不良反应包括过敏反应、消化系统、神经系统和内分泌系统反应等,其肝毒性反应值得重视。
  • 病例报告
    Zhu Caiyong;Sun Aijuan;Zhen Ying
    . 2008, 10(6): 0-0.
    Three patients experienced musculoskeletal pain after treatment with acitretin.The first patient, a 35-year-old woman with palmoplantar pustulosis, ingested acitretin 30 mg/d. After one week of treatment, she experienced myalgia in her right shoulder, back, and right upper limb, so she reduced acitretin dosage to 20 mg/d herself, and her pain symptoms disappeared after a week. Half a month later, she increased acitretin dosage to 30 mg/d again for her poorly controlled palmoplantar pustulosis. Three days later, the myalgia reappeared at the same sites, so her acitretin dosage was decreased to 20 mg/d again, and her pain symptoms disappeared after a week.The second patient, a 42-year-old man with palmoplantar pustulosis, ingested acitretin 30 mg/d. Nine days later, he developed severe generalized musculoskeletal pain, which significantly interfered with his daily activities. The patient discontinued acitretin himself, but his pain did not disappear after a week. Subsequently, he received oral nonsteroidal antiinflammatory drugs, and his symptoms resolved gradually after five days.The third patient,a 57-year-old man with psoriasis, ingested acitretin 30 mg/d. Five days later, he developed bilateral knee joint pain. Acitretin was stopped at once. Three days later, his pain disappeared completely.
  • Huang Yuan, Xie Jianhui, Mei Haibo, Tan Qian, Zhao Xin, Ouyang Yaqi, Yi Yinzhi, Mo Shasha
    Adverse Drug Reactions Journal. 2021, 23(5): 260-265. https://doi.org/10.3760/cma.j.cn114015-20210101-00001
    Objective To explore the safety of pamidronate disodium as adjuvant therapy in children with congenital pseudarthrosis of tibia (CPT).  Methods Medical record data of children with CPT who received pamidronate disodium for the first time and completed 3 doses of treatment during hospitalization in Department of Orthopedics, Hunan Children′s Hospital from July 1, 2019 to June 30, 2020 were collected and analyzed retrospectively. The regimen of medication was slow IV infusion of pamidronate disodium 0.5-mg/kg on day 1 and 1.0-mg/kg on days 2 and 3, dissolved in 0.9% sodium chloride injection 250-ml (the infusion time was >3 hours). Adverse reactions were monitored during and after the IV infusion. Peripheral venous blood was collected 2-3 hours after finishing the 3rd dose of treatment and blood calcium and phosphorus levels were detected. The children were divided into ≤1 year old group, >1-3 years old group, and >3 years old group, and the occurrence of adverse reactions in different age groups were compared.  Results A total of 81 children were enrolled in the analysis, including 54 males and 27 females, aged 0.4 to 15.4 years, with 10 cases in the ≤1 year old group, 46 in the >1 to 3 years old group, and 25 in the >3 years old group. After medication in the 81 children, fever with temperature ≥38.0-℃ occurred 53 times in 34 children (42.0%), of which 39 times were grade 1 (38.0-39.0-℃) and 14 times were grade 2 (>39.0-40.0-℃). The incidence of fever on the day after the 2nd dose was significantly higher than that after the 1st and 3rd doses (all P<0.05). The differences in the incidence of fever and the degree of fever among the 3 groups were not statistically significant (all P>0.05). The temperature of children with fever decreased to below 38.0-℃ within 1-16-hours after drug-therapy or physical cooling. After the 3rd dose of treatment, the levels of serum calcium and phosphorus were significantly lower than those before administration [(2.06±0.17) mmol/L vs. (2.42±0.12) mmol/L, (1.01±0.23)mmol/L vs. (1.71±0.18)mmol/L, all P<0.001]. The incidences of hypocalcemia and hypophosphatemia were 56.8% (46/81) and 19.8% (16/81) respectively, but none of patients with hypocalcemia and hypophosphatemia had obvious related symptoms. Conclusions Pamidronate disodium is safe as adjunctive therapy in children with CPT. The main adverse reactions are fever, asymptomatic hypocalcemia, and hypophosphatemia. Fever can be recovered quickly after intervention, and the levels of serum calcium and phosphorus can return to within the normal range after drug withdrawal.
  • 调查研究
    Yang Meizhen;Liu Fang
    . 2008, 10(2): 100-4.

    Objective: To investigate the case reports of paraplegia resulting from intrathecal methotrexate administration and to analyse the factors influencing prognosis of paraplegia. Methods: Eleven case reports of paraplegia resulting from intrathecal methotrexate administration were collected from the database of Chinese medical literature between 1978 and 2007. The patients sex and age, dosage of methotrexate, combination with cytavabine, dosage of cytarabine, frequency of intrathecal injection, onset time and outcome of paraplegia were investigated. The factors influencing the prognosis were analyzed. Results: Of the 11 patients, 4 were reversible and 7 were irreversible. There was no statistical deference in sex, age, and the level of the injury to the spinal cord between reversible and irreversible cases (P>0.05). Less frequent intrathecal injection, more rapid onset of paraplegia after the last injection, lower dosage, and fewer combination with cytarabine were found in reversible cases compared with irreversible cases. The diffences were statistically significant (P<0.05). Conclusion: The possible causes of unfavourable prognosis were more frequent intrathecal injections, paraplegia occurring over 24 hours after the last injection, higher dosage, and combination with cytarabine.

  • 药物评介
    . 2004, 6(3): 170-173.
  • 病例报告
    Wang Hua
    . 2007, 9(5): 362-362.
    A 62-year-old woman with acute interstitial nephritis and mesangial proliferative glomerulonephritis was treated with IV methylprednisolone 80 mg.After about five minutes of infusion,she developed nasal obstruction,nasal discharge,sneezing,tongue numbness,generalized pruritus,sporadic urticaria on her chest and back.The infusion was stopped immediately,and she was treated with loratadine 10 mg by mouth and IV calcium gluconate 10 ml.Half an hour later,her symptoms disappeared almost completely.
  • 调查研究
    He Rong;Liu Zhuang;Duan Xuefei
    . 2003, 5(6): 374-377.
    Objective: To observe adverse effects in SARS patients receiving corticosteroids. Method: 98 SARS cases were treated with or without corticosteroids, that is, divided into treatment group(57 cases) and control group(41). The former was then subgrouped under three different doses of the drug:<160mg/day(16 cases), ≥320mg/day(6) and in-between(35); and under different administration duration: <20 days(19 cases), ≥20 days(38). The adverse effects were compared between corticosteroids groups and control group. Results: In corticosteroids groups and control group, hypopotassemia was 43.9% and 26.8%, elevation of blood-glucose concentration was 45.6% and 22.0%, secondary infections were 31.6% and 14.6% respectively. Fever recurred markedly in the former(38.6%) during a gradual reduction in dosage while 17.1% in the latter. Thoracic x-ray manifestations showed more severe inflammation in the former (21.1%) than in the latter (7.3%). And occurrence rates of unwanted reactions were positively related with the doses and duration of treatment among corticosterodis groups. Conclusion: Corticosteroids treatment of SARS infection may result in hypopotassemia, elevation of blood glucose and more secondary infections. When its dosage reduces gradually, fever would recurred.
  • 病例报告
    GAO Feng.
    . 2012, 14(2): 129-2.
    A 49-year-old woman with acute upper respiratory tract infection received an IV infusion of cefmetazole 2.0 g in 250 ml of 0.9% sodium chloride solution twice daily. After 3 days of treatment, her symptoms improved and cefmetazole was stopped. Fifteen days later, pain and swelling occurred in her left forearm. Blood vessels from the puncture site to the elbow showed a obvious bulge in the skin and cord-like change, an increase in hardness of the vein, venous tenderness, scattered and variable size of erythema along the vein. She was diagnosed with delayed phlebitis. Topical magnesium sulfate solution, dexamethasone for injection, and melilotus extract tablets were given. After 4 weeks, her symptoms subsided gradually, the color of vessels changed from red to brown. After 12 weeks, the color of the vessels normalized. There was a slight decrease in hardness of the vein and blood vessels were less elastic.
  • Xiong Yu, Bian Yuan, Tang Xiting, Tong Rongsheng, Cui Xiaojiao, Jiang Min, Yang Zhiyong
    Adverse Drug Reactions Journal. 2020, 22(6): 373-374. https://doi.org/10.3760/cma.j.cn114015-20200316-00281
    A 50-year-old male patient with agitated depression and hyperlipemia received oral amoxicillin and clavulanate potassium 0.5 g once daily and 2 lopinavir and ritonavir tablets twice daily for novel coronavirus infection, based on previous drugs including quetiapine, clonazepam, and atorvastatin calcium. After 3 days, lopinavir and ritonavir was changed to oral arbidol 200-mg, thrice daily due to suspicious drug interaction. After taking arbidol for 3 days, the patient developed red papules on the whole body. Considering that it might be related to amoxicillin and clavulanate potassium, the drug was stopped and loratadine was given. But the rashes were aggravated. Considering that the drug eruption was caused by arbidol, arbidol was discontinued and the rashes subsided in a large area the next day. Then vitamin C injection, calcium gluconate injection, and ribavirin were added. After 5 days, the rashes subsided completely. After 17 days, the patient recovered from pneumonia.
  • . 2015, 17(3): 184.
  • 病例报告
    WANG Li-jun;ZHAN Han-qiu
    . 2012, 14(3): 186-2.

    A 39-year-old man with chronic active hepatitis B and type 2 diabetes mellitus received compound glycyrrhizin, glutathione, polyene phosphatidylcholine, coenzyme complex, alprostadil, thymopentin and diammonium glycyrrhizinate, followed by entecavir, acarbose, and bicyclol. He then developed scattered maculopapular involving his entire body, with partial confluence on his chest and abdomen. Drug-induced rash was considered. All drugs were discontinued except entecavir. He was treated with methylprednisolone, calcium gluconate, vitamin C and loratadine, but these were ineffective. He subsequently had a large area of skin rash and worsening edema with blister, erosion, and desquamation. He was diagnosed with toxic epidermal necrolysis associated with entecavir. Entecavir was discontinued immediately and anti-anaphylactic treatment was continued. Ten days after the withdrawal of the entecavir, his skin lesions improved and, twenty days later, his skin eruptions disappeared completely.

  • 调查研究
    Song Yan;Yao Fenghua;Zhang Yiyan;Zhang Liwei;Li Yijun;Chen Fengkun
    . 2006, 8(4): 266-268.
    Objective:To investigate the clinical characteristics of renal injury caused by Guanxinsuhe pills.Methods:Restrospective study was done in 11 patients with renal injury caused by Guanxinsuhe pills.The clinical characteristics of renal injury,and the relationship between medication,the course of disease,and renal injury were analysed.Results:The dosage in 7 of 11 cases was as pharmacopoeia prescribes,but 4 patients was on overdose of the drug.The duration of treatment was 2~120 months(87.8±58.6),and 150~8760 pills(6084.6±1221.0)were used.The renal injury occurred within 4~216 months(41.1±36.6)after initiation of the drug use.All patients were diagnosed as chronic tubulointerstitial nephropathy with renal tubular acidosis,renal glucoseuria and hyposthenuria.The severity of anemia was not parallel to renal dysfunction.The symptoms were fatigue,anorexia,nausea,vomiting,polyuria or increased nocturia,and accompanied with various severity of chronic renal dysfunction.Urinary protein was less than 1.0 g/24 h.Seven patients were chronic renal diseases in level 4~5,and 4 patients were in level 3.Conclusion:Guanxinsuhe pills could cause renal injury,the mechanism of adverse reactions may associated with aristolochic acid containing in Radix Aristolochiae,which is an ingredient of Guanxinsuhe pills.
  • 抗菌药应用讲座
    . 2008, 10(2): 129-2.
  • 学术讨论
    . 2000, 2(4): 248-253.
    我国目前不合理用药形势十分严峻,极大地影响到卫生保健体制改革的顺利进行,必须研究出一套行之有效的解决办法。本文是合理用药系列文章的第3篇,从宏观调控的角度出发,营造合理用药的氛围,提高全民的合理用药意识,完善相应的药品监督管理制度和评价体系,以充分发挥医疗机构乃至药师的作用,并围绕如何促进合理用药的问题,提出具有普遍意义的对策供讨论。
  • 病例报告
    . 2002, 4(5): 337-337.
  • ADE简报
    . 2000, 2(3): 198-198.
  • Wei Min, Xia Zongling
    Adverse Drug Reactions Journal. 2020, 22(9): 527-528. https://doi.org/10.3760/cma.j.cn114015-20190513-00416
    A 63‑year‑old male patient with lung metastases from bladder cancer received IV infusions of nivolumab (1 mg/kg) and ipilimumab (3 mg/kg) once every 21 d. On day 3 after the second medication, the patient developed paroxysmal chest tightness, which could be self‑mitigated by lying down for several minutes. Laboratory tests showed high‑sensitive troponin Ⅰ 4 340 ng/L and creatine kinase  (CK)‑MB 98.9 μg/L. Immune‑related myocarditis due to combination use of nivolumab and ipilimumab was considered. After methylprednisolone with prednisone sequentially and symptomatic and supportive treatments such as fluid infusion, liver and stomach protection, improvement of myocardial metabolism, and reduction of oxygen consumption, the patient′s symptoms were improved obviously. Laboratory tests showed  high-sensitive troponin Ⅰ 192 ng/L and CK‑MB 28.4 μg/L.

     

  • 病例报告
    CHEN Qiu-hong;SHI He-kun
    . 2012, 14(3): 183-2.

    A 60-year-old male with fracture received an IV infusion of propylgallate 180 mg in 0.9% sodium chloride 250 ml for prevention of deep vein thrombosis after undergoing surgery. About ten minutes later,the patient abruptly developed chest tightness, dyspnea, pallor, lip cyanosis, and cold peripheral extremities. ECG monitoring revealed a heart rate of 104 beats/min, his blood oxygen saturation was 0.85, and his blood pressure was 80/50 mm Hg. Propylgallate was discontinued immediately. Anti-allergic treatment, blood volume expansion, and mask oxygen were given. Twenty minutes later, his anaphylactic symptoms gradually improved, his blood oxygen saturation increased to 0.96, and his blood pressure increased to 100/58 mm Hg.

  • 安全用药
    Liu Xiao;Zhou Ying;Cui Yimin
    . 2011, 13(2): 95-4.
    Fluoroquinolone antibacterials levofloxacin, ciprofloxacin, gatifloxacin and moxifloxacin have been reported to cause torsades de pointes (TdP). Clinical manifestations of TdP are dizziness, fainting, or even cardiac arrest. QT interval prolongation and TdP are visible on the electrocardiogram (ECG). The mechanism of TdP is unclear, it may be associated with inhibition of cardiac K+ channels and blocking of K+ outflow. The risk factors for causing TdP are female, advanced age, underlying organic heart disease (especially congestive heart failure, QT interval prolongation and bradycardia), liver and kidney dysfunction, hypokalemia, and hypomagnesemia, as well as combined use with other drugs that can cause QT interval prolongation. Once a patient develops to QT interval prolongation and TdP, the causative agent should be discontinued immediately. Potassium and magnesium supplements are given to inhibit the early afterdepolarization. Artificial temporary cardiac pacing or isoprenaline is used to maintain normal heart rate. For the unconscious patient with ventricular fibrillation, external electrical cardioversion could be carried out.
  • 综述
    . 2007, 9(2): 77-80.
    普拉克索为新一代非麦角碱类选择性多巴胺D2和D3受体激动剂。该药能有效改善早期及晚期帕金森病的运动症状,延缓和减轻左旋多巴相关运动并发症的发生和程度,并能缓解帕金森病伴发的抑郁症状。普拉克索的不良反应轻微,不引起肺纤维化等并发症,但其所致的幻觉、嗜睡和突然入睡等不良反应值得临床医师重视,以加强临床用药的安全性。
  • 中毒救治
    Wang Zhe;Niu Wenkai;Qiu Zewu
    . 2007, 9(6): 410-411.
    A 26-year-old woman ingested a sigle dose of vitamine C Yinqiao<、i> 150 tablets(containing paracetamol 15.75 g).Six hours later,she developed dizziness,nausea,and vomiting.And 14 hours later,her symptoms were aggrevated to asthenia,mild yellowing of the skin and mucous membrane,and percussion tenderness over hepatic region.The laboratory tests revealed the following values:ALT 6 127 U/L,AST 4 014 U/L,Tbil 40 μmol/L,Dbil 21 μmol/L,APTT 27.9 s,and PT 29.4 s.She was diagnosed with acute severe liver damage due to paracetamol poisoning.The patient was given symptomatic treatment for 3 weeks.And then her liver function returned to normal limits.
  • 安全用药
    . 2004, 6(5): 309-312.
    查阅国内外有关非典型抗精神病药物与体重增加的临床试验资料和文献,并进行整理、分析。结果发现,非典型抗精神病药物氯氮平、奥氮平、奎硫平、左替平、利培酮均不同程度地引起体重增加,而齐哌西酮对体重的影响较小;体重增加一般发生于用药6~12周。本文对非典型抗精神病药物致体重增加的药理学机制及药物的顺应性等问题进行介绍。
  • Yang Yu, Huang Yayun, Zhang Yunxia, Qin Qianqian, Xue Zhimin, Zhao Ruiling, Xu Xinwen, Wang Xiaoling
    Adverse Drug Reactions Journal. 2023, 25(5): 281-286. https://doi.org/10.3760/cma.j.cn114015-20220527-00475
    Objective To analyze the information related to child-prohibition in drug labels in China. Methods The existing drug labels for chemical drugs and biological products included in the China Pharmacopoeia 2020 (Ch.P) were collected through searching websites such as "Yaozhiwang" "Dingxiangyuan" and "Yimaitong", and information related to child-prohibition was extracted. The expression and existing problems of information about child-prohibition were analyzed. Results A total of 1-741 and 149 chemical and biological products were included in the Ch.P, respectively, of which 411 (23.6%) and 6 (4.0%) products involved information of child-prohibition. Information of child-prohibition was expressed in 18 ways, such as "prohibited" "not recommended" and "try not to", etc. Issues of child-prohibition information in drug labels of the same drug from different manufacturers were inconsistent text descriptions, inconsistent age range, and incomplete information on whether there was benzyl alcohol; issues in the same drug label was different age ranges for child-prohibition in different chapters. Conclusions There are inconsistencies and non-standard issues in information related to child-prohibition in the existing drug instructions in China. Drug manufacturers should conduct full lifecycle management of drug labels in accordance with the "Technical Guidelines for Writing Information on Children′s Medication in the Instructions of Chemical Drugs and Therapeutic Biological Products (trial)", and continuously standardize and improve the information of child-prohibition.
  • 中毒救治
    Wei Zhaofu
    . 2008, 10(5): 0-0.

    Aluminium phosphide is a pesticide. It reacts with the wet, water or acid to form hydrogen phosphide(PH3),a very toxic gas, which produces inhibition of the cytochrome oxidase, blocking the electron transfer chain and oxidative phosphorylation producing an energy crisis in the cells. The latent period of acute aluminium phosphide poisoning is within 24 hours, and in most patients it is 1~3 hours. Symptoms of exposure to hydrogen phosphide gas include headache, dizziness, nausea, vomiting, and difficulty breathing. Severe exposure may damage liver, kindneys, lungs, nervous and circulatory systems, and may cause death. Diagnosis of aluminium phosphide poisoning is made from exposure history and clinical presentations. Treatments include gastric lavage, oxygen supplementation, blood purification, administration of intravenous dopamine, corticosteroids, and magnesium sulfate. This paper presents a patient died from hydrogen phosphide gas inhalation. A 19-yearold woman, who lived in a room which had aluminium phosphide and the wet floor, was hospitalized with upper abdominal pain, nausea, vomiting, dizziness, and fatigue. The next day, she presented with incontinences of feces and urine, unconsciousness, cyanosis, wet rale in both lung, a heart rate of 40 heats/min, a blood pressure of 70/40 mmHg, a respiration rate of 10~12 breaths/min. Her ECG showed bradycardia. Laboratory testing revealed the following values: WBC 12.3×109/L, BUN 15.3mmol/L, SCr 171 μmol/L, CPK 260~710 U/L, LDH 240~695 U/L, AST 463 U/L, ALT 398 U/L, ALP 230 U/L, TBil 36.3 μmol/L, phosphate 1.68 mmol/L, calcium 1.6 mmol/L, and magnesium 0.45 mmol/L. She was diagnosed with aluminum phosphide poisoning. Despite treatment with oxygen, vasoactive substances, and other protective and symptomatic therapy, the patient died from multiorgan failure.

  • 综述
    . 2001, 3(1): 5-9.
    喹诺酮类药物抗菌谱广、抗菌活性强,与其它抗生素无交叉耐药性而为临床广泛应用,但其治疗儿科感染性疾病的安全性尚未得到公认。实验证实喹诺酮类药物对幼年动物骨关节有损害,但许多临床资料表明对儿童关节的毒性并不如动物实验中那样严重。因此,使用原则是不作为感染性疾病的首选药。当其它药物治疗无效时,在掌握剂量和疗程的情况下,可谨慎使用。
  • . 2015, 17(2): 81-83.
  • 综述
    Xie Qiufen;Xiang Qian;Zhou Ying;Cui Yimin
    . 2014, 16(6): 362-5.
    Amiodarone, one of Class Ⅲ antiarrhythmic drugs, may lead to hepatic injury, the incidence of which is about 14% to 82%. Clinical manifestations differ widely from asymptomatic elevated liver enzymes to fulminant hepatic failure and even death. Histopathological findings are similar to those of alcoholic liver disease and characterized by lysosomes phospholipidosis and granular cells. Pathogenesis includes toxicity of amiodarone and its major metabolite, immunological mechanisms, and genetic factors. Intravenous AIHI is mainly related to the effect of cosolvent, polysorbate 80. Men, heart failure and plasma concentration >2.5 mg/L may be risk factors. Indications to use amiodarone should be strictly controlled and patients′ physical conditions should be considered for choosing methods of administration. Monitoring closely is needed for liver function and/or blood concentration during treatment. When liver function is abnormal, weigh the benefits and risks of treatment carefully, and decide whether dosage reduction or withdrawal of the drug is necessary.
  • 论坛
    Zhang Xue;Wu Jiarui;Dong Ling
    . 2014, 16(1): 7-3.
  • Zhang Wei, Feng Linlin, Ping Zhao
    . 2015, 17(2): 130-133.
    Steroid-induced osteonecrosis of femoral head(SONFH)is the pathological process of the active ingredient of the femoral head death caused by the high-dose or long-term use of glucocorticoids. The SONFH is associated with gene polymorphisms included blood coagulation system components, drug metabolizing enzymes and transporters, lipid metabolism proteins, vascular endothelial growth factor gene. The researches of SONFH-related gene polymorphisms provide the basis of  investigation of disease′ pathogenesis, early prevention, and implementation of individualized treatment. However, due to the differences in national, regional, and testing methods and the difficulties in collecting cases of SONFH and control group which did not develop osteonecrosis after using hormone, some findings are inconsistent and the further large sample, multi-center, standardized tests still needed to confirm.
  • 论著
    Zheng Xizi;Su Tao;Wang Yu
    . 2011, 13(4): 218-5.

    Objective: To investigate the clinical characteristics and treatment of fluoroquinolone-induced acute interstitial nephritis. Methods: Clinical data on patients who were definitely diagnosed as having fluoroquinolone-induced acute interstitial nephritis in Department of Medicine and Institute of Nephrology, Peking University First Hospital between January 2002 and September 2010 were collected and retrospectively analyzed. The baseline characteristics, fluoroquinolone usage, combined therapy, laboratory tests, pathological examination of the kidney, and follow-up were recorded. Results: Five patients [3 males and 2 females with average age of (48.6±6.1) years] were enrolled in the study. Of them, 3 patients received levofloxacin and 2 received pefloxacin for urinary infections or fever. The duration of the treatment was 1 to 12 days. The time to onset of an elevated serum creatinine level after drug administration was 7 to 15 days [average (11±3) days]. The patients developed nausea,vomiting,congestive rash, fever, and chills. Laboratory tests showed that 12-60 days after treatment start, the 5 patients developed elevated serum creatinine and urine protein levels, and abnormal urine acidification capability in varying degrees, accompanied by haematuria (4 cases), renal glycosuria (4 cases), elevated urinary α1-MG level(3 cases), and aseptic leukocyturia(2 cases).Clinical symptoms disappeared 1 to 2 days after drug withdrawal, but serum creatinine levels, routine urine test results, microscopic examination of urinary sediment, and urine acidification capability did not return to normal. After 1 to 6 weeks of glucocorticoid therapy,serum creatinine levels returned to the normal ranges, urine protein levels decreased, and haematuria, glycosuria and aseptic leukocyturia disappeared, but urinary α1-MG and urine acidification capability in some patients remained abnormal. Conclusion: The clinical presentation of fluoroquinolone-induced acute interstitial nephritis is lack of specificity. Routine blood and urine tests and kidney function test should be performed regularly during the period of fluoroquinolone therapy. If acute interstitial nephritis occurs, the drug should be discontinued immediately, and glucocorticoid therapy might be given.

  • 综述
    . 2004, 6(6): 361-365.
    药物相关性血栓性血小板减少性紫癜/溶血尿毒症综合征(TTP/HUS)的发病机制主要为免疫介导或药物的直接毒性作用,不同药物引起TTP/HUS的临床表现和预后有所不同。目前有必要制订药物相关性TTP/HUS的诊断标准和治疗方案,以便及时、准确地做出诊断,并尽早给予合理治疗。
  • 综述
    . 2004, 6(2): 73-77.
    近年研究发现,环氧化酶有两种同工酶,即COX-1和COX-2。COX-1对机体功能具有生理性保护作用,而COX-2主要参与炎症等病理反应的调节。非甾体类药物的抗炎镇痛等作用源于对COX-2的抑制,而胃肠道等不良反应的发生则与COX-1被抑制密切相关。本文介绍了COX-1与COX-2的主要特点;目前已上市的几种选择性COX-2抑制剂及其在治疗肿瘤、老年性痴呆、动脉粥样硬化等方面的前景;以及增加心血管不良事件等方面研究进展。
  • 调查研究
    Zhang Renlinga;Qi Yingb;Wang Yuqingc
    . 2009, 11(3): 179-4.
    Objective: To investigate the clinical features of oedema and the changes in liver and renal function and thyrotropin level in type 2 diabetic patients following the addition of pioglitazone. Methods:Eight type 2 diabetic patients receiving hypoglycemic agents plus pioglitazone from January to December in 2008 were enrolled in the retrospective investigation. The 8 patients comprised 2 men and 6 women with age of 5268 years \[average age (58.62±5.65) years\]. All patients received more than 2 hypoglycemic agents (metformin, gliquidone, nateglinide, insulin, repaglinide, and acarbose), followed by pioglitazone 1530 mg daily. The time of oedema onset and disappearance and its clinical features were investigated in patients following the addition of pioglitazone. Before and during pioglitazone administration and 2 weeks after oedema disappearance, the urinary analysis, liver and renal function tests were performed. In addition, the TSH level was measured after oedema onset and 2 weeks after oedema disappearance. Results: All patients developed oedema 510 days after pioglitazone start, and its features were bilateral pitting oedema in both feet and legs. The oedema subsided 27 days after pioglitazone withdrawal. The laboratory tests before and during pioglitazone administration and 2 weeks after oedema disappearance revealed that urinary protein was negative; the median serum urea level was 6.20 mmol/L, 6.36 mmol/L, and 5.90 mmol/L, respectively; the median SCr level was 83.5 μmol/L, 87.0 μmol/L, and 78.0 μmol/L, respectively; the median ALT level was 31.5 U /L, 32.0 U /L, and 33.0 U /L, respectively. The TSH level after oedema onset and 2 weeks after oedema disappearance was 7.1 mU/L and 6.9 mU/L, respectively. Conclusion: Type 2 diabetic patients receiving hypoglycemic agents may develop pitting oedema in both feet and legs following the addition of pioglitazone, but there is no effect on liver and renal function and thyrotropin level, and oedema rapidly resolved after pioglitazone discontinuation.
  • 安全用药
    . 2005, 7(3): 182-185.
    近年来发现,许多非心血管药物也可引起Q-T间期延长和诱发尖端扭转型室速(TdP)。本文对可能引起此类不良反应的非心血管药物、作用机制及防治措施作一简要介绍。
  • 论著
    Luo Leiming;Ye Ping;Zhu Qiwei;Zhang Ling;Zhu Bing;Yang Xue;Shi Jun;Zhang Minghua;Liu Guoshu
    . 2007, 9(3): 158-161.
    Objective: To evaluate the efficacy and safety of simvastatin plus acipimox for treating combined hyperlipidemia. Methods: Sixty-three patients with coronary heart disease and combined hyperlipidemia were divided into the following two groups: simvastatin plus acipimox group(32 cases) and simvastatin group(31 cases). All patients in the two groups were receiving anti-ischemia therapy. The patients in simvastatin plus acipimox group were administered with simvastatin 20 mg/day and acipimox 500 mg/day. The patients in simvastatin group were administered with simvastatin 20 mg/day. The duration of treatment was 3 months. The changes in serum lipid concentrations were compared between the two groups before and after the treatment. The adverse reactions were recorded.. Results: After treatment, the levels of the serum total cholesterol(TC), low density lipoprotein cholesterol(LDL-C), and triglyceride(TG) were decreased in two groups. But in simvastatin plus acipimox group, they were significantly decreased, and the high density lipoprotein cholesterol(HDL-C) level was increased. The incidence of adverse reactions in the two groups were similar, except the skin reactions were more frequent in simvastatin plus acipimox group. Conclusion:The regimen of simvastatin plus acipimox is capable of lowering LDL-C, TC, and raising HDL-C. It is an effective and safe therapy in treatment of combined hyper- lipidemia.
  • Li Zhengrong, Zhang Zonglin, Ou Zhihong, Shi Zengcheng, Li Junsheng, Che Fengyuan
    . 2017, 19(4): 260.
    ObjectiveTo select drugs inducing international normalized ratio (INR) elevation by concomitant use of warfarin in inpatients.MethodsThe data of inpatients with increased INR rise (INR>3.50) because of concomitant use of warfarin and other drugs in Linyi People′s Hospital, Shandong University from January 2012 to December 2016 were collected and analyzed retrospectively. The baseline conditions, combination drugs, INR rise during treatments, bleeding events, treatments and outcomes in inpatients were recorded. Drugs that could increase anticoagulant effect of warfarin were screened.ResultsA total of 100 patients were enrolled in this study, including 43 men and 57 women aged from 26 to 86 years with an average age of (64±13) years. Primary diseases in 64 patients were atrial fibrillation, in 15 patients were after heart valve replacements, in 10 patients were pulmonary embolism, in 7 patients were lower extremity venous thrombosis, and in 4 patients were myocardial infarction with left ventricular thrombus. Hospital stay were 5-39 d and the average time was (17±7) d; the time of warfarin treatments were 3-36 d and the average time was (11±5) d. Of the 302 kinds of drugs combined with warfarin in the 100 patients, 40 kinds of drugs were found to induce INR elevation, including 16 kinds of anti-infective drugs (66 cases), 7 kinds of endocrine system drugs (28 cases), 4 kinds of cardiovascular system drugs (30 cases), 4 kinds of nervous system drugs (5 cases), 3 kinds of proton pump inhibitors (21 cases), 3 kinds of blood system drugs (4 cases), 2 kinds of proprietary Chinese medicine preparations (10 cases), 1 kind of non-steroidal anti-inflammatory drugs (2 cases). According to the number of drug use, the top ten drugs were piperacillin sodium and tazobactam sodium (27 cases), methylprednisolone (22 cases), levofloxacin (20 cases), amiodarone (20 cases), omeprazole (19 cases), cefoperazone sodium and sulbactam sodium (11 cases), fluvastatin sodium (10 cases), compound liquorice preparations (9 cases), voriconazole (7 cases), latamoxef (4 cases), and moxifloxacin (4 cases). The number of drug combination was 1-5 kinds in each patient, combination drug was 1 kind in 31 cases, 2 kinds in 46 cases, 3 kinds in 18 cases, 4 kinds in 4 cases, and 5 kinds in 1 case. Of the 100 patients with INR elevation, 83 patients stopped taking warfarin and 13 patients were given intramuscular injection of vitamin K1 at the same time, 17 patients′warfarin dose was decreased from 1.25-3.75 mg to 0.75-3.00 mg, then the INR levels in all patients decreased to <3.0. Seven patients had mild bleeding before warfarin withdrawal, including 4 cases of subcutaneous hemorrhage, 1 case of subarachnoid hemorrhage, 1 case of hematochezia, and 1 case of blood in phlegm.ConclusionsMany commonly used drugs in clinical practice, such as compound preparations of β-lactam antibiotics and β-lactamase inhibitors, quinolones, glucocorticoid, anti-arrhythmic drugs, and proton pump inhibitors, etc., could cause INR elevation and increase bleeding risk.
  • Wang Yujie, Yue Qingxi, Yuan Yongfang
    . 2016, 18(6): 444.
    Genetic polymorphisms of drug-metabolizing enzymes and drug transporters play an important role in antineoplastic drugs toxicity. Drug metabolizing enzymes are associated with antineoplastic drug toxicity include cytochrome P450, flavin-containing monooxygenase, monoamine oxidase, diamine oxidase, alcohol dehydrogenase, catalase, aldehyde dehydrogenase, glutathione S-transferase, UDP-glucuronosyl transferase, sulfotransferase, N-acetyltransferase 2 and thiopurine methyltransferase. Drug transporters are associated with antineoplastic drug toxicity including organic anion transporting polypeptide, organic anion transporter and ATP-binding cassette. Most gene function and single-nucleotide polymorphism are associated with antineoplastic drug toxicity are unclear. Gene bank improved continuously and clarifying the mechanism of between drug toxicity and polymorphisms could promote the individualized treatment and reduce the risk of adverse drug reactions.
  • Tang Hongbo;Zhou Zhimin;Yan Suying;Liang Xinyun;Li Yifan;Dai Yinmei;Feng Xin
    . 2015, 17(1): 44-5.
    Nano drug delivery system (NDDS) is a kind of drug delivery system which are made up of drugs and drug carriers and their particle sizes are less than 1 000 nm. In general, polymeric micelles, liposome, nano capsule, microemulsion, and organic or inorganic nanoparticles are used as carriers in NDDS, pharmacodynamic substance and carriers are combined into new type of controlled/slow release preparations or the drugs are directly processed into nanoparticles. Embryo toxicity is an important index for non-clinic safety evaluation of NDDS. The in vitro studies showed that embryo toxicity of NDDS is related to physical and chemical properties of nanoparticles, such as size and modification materials on surface, exposure time of nanoparticles, and dosage. It has been shown that zinc oxide nanoparticles have embryo toxicity, titanium dioxide, silica, magnesium oxide, and quantum dots have different degrees of embryo toxicity, and polystyrene based nanoparticles have no embryo toxicity. The in vivo studies showed that zinc oxide nanoparticles, quantum dots containing cadmium or selenium, and high concentrations of nano silver have embryo toxicity in one or several animal models, such as rat, mouse, zebrafish, Paracentrotus lividus, Xenopus laevis, and Mytilus Galloprovincialis. Silica, titanium dioxide, chitosan nanoparticles and single-walled carbon nanotubes at different dose and size showed different effects on embryonic development of different animal models. Embryotoxic or teratogenic effects of NDDS include stagnation, miscarriage, and deformity, and the mechanism of toxicity is mainly related to oxidative stress and inflammation. Though embryo toxicity of NDDS in models, methods and content need further exploration and research, studies which have been carried out provide important references for further research.
  • 安全用药
    Lei Zhaobao
    . 2010, 12(2): 105-4.
    Statins are inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase .They have actions on reduction of endogenous cholesterol synthesis and are mainly used for the treatment of hypercholesterolemia, mixed hypercholesterolemia, and for the prevention of coronary heart disease and stroke. The most common adverse reactions of statins are diarrhea, nausea, headache and rash. Erectile dysfunction (ED) in association with statins was first reported by Bruckert in 1996. A total of 4 471 case reports of statininduced adverse reactions were collected by French Pharmacovigilance System from 1 January 1985 to 31 December 2006.Of them, 51 reports(1.14%) were statin-induced ED, including simvastatin (19 cases), atorvastatin (18 cases), pravastatin (8 cases), rosuvastatin (4 cases), and fluvastatin (2 cases). The mean time to ED onset after starting statins was 62 days (median 29 days, range 1-100 days): 25% of patients within 9 days and 75% of patients within 75 days after starting statins. Approximately 57% of cases recovered after withdrawal of statins. The mechanism of statin-induced ED may be attributed to the influence of cholesterol reduction on steroid hormone (including testosterone) synthesis, as well as individual differences and psychological state. The preventive and therapeutic measures are as follows: concomitant use of drugs that may caused ED should be avoided, such as antipsychotics, tricyclic antidepressants, fibrate lipid-lowering drugs, and β-blockers; if ED induced by statins is confirmed,the statins should be discontinued or changed to other lipid-lowering drugs.
  • 调查研究
    Wei Jianying;Kang Shulan
    . 2000, 2(2): 86-88.
    131 perioperative cases in 1999 were randomly sampled from medical records of our hospital. An investigation of antimicrobials administration was done, including different kinds, use in combination, frequency and duration .
  • 观察研究
    Cui Huijuan;Li Oujing;Tan Huangying;Li Yuan
    . 2009, 11(4): 249-4.
    Objective: To observe the efficacy of Huangqi injection in prevention and treatment of neurotoxicity induced by oxaliplatincontaining chemotherapy regimen. Methods:From September 2006 to September 2008, 40 patients with stomach or large intestinal cancer were enrolled in the study. The patients comprised 23 men and 17 women with age of 32-75 years (mean age 60 years) and were randomly divided into two groups: The test group and the control group (20 cases in each group). All patients were treated with one cycle of a oxaliplatincontaining chemotherapy regimen, which comprised oxaliplatin 130 mg/m2 on day 1, fluorouracil 0.5 g on days 1-5, and calcium foliate 0.2 g on days 15; in the test group, 30 ml of Huangqi injection was added to the regimen on days 1-7. The manifestation of peripheral neurotoxic reactions was observed and nerve growth factor levels were measured. Results: The situation of neurotoxicity occurring was as follows: in the control group, 2 patients had grade 0 toxicity, 10 had grade 1 toxicity, 6 had grade 2 toxicity, and 2 had grade 3 toxicity; in the test group, 14 patients had grade 0 toxicity and 6 had grade 1 toxicity. The incidence rate of neurotoxicity in the test and control groups was 30% and 90%, respectively. The difference was statistically significant (P<0.01). In the test and control groups, the nerve growth factor levels were(167±10)ng/ml and(204±19)ng/ml before chemotherapy as well as(152±8)ng/ml and(133±12)ng/ml 2 days after chemotherapy, respectively. In the control group, the nerve growth factor levels were markedly decreased 2 days after chemotherapy compared with before chemotherapy. The difference between the two groups was statistically significant (P<0.01). Conclusion: Huangqi injection has some degree of efficacy in prevention and treatment of neurotoxicity induced by oxaliplatincontaining chemotherapy regimen.
  • 病例报告
    . 2000, 2(4): 254-254.
  • 安全用药
    . 2004, 6(4): 248-250.
    多西紫杉醇主要作用于肿瘤细胞的M期,属细胞周期特异性药物。抗肿瘤效果与紫杉醇相当,或对部分肿瘤的疗效稍高于紫杉醇。临床上主要用于卵巢癌、转移性乳腺癌和非小细胞肺癌等,疗效显著。多西紫杉醇的主要不良反应包括骨髓抑制、液体潴留、血管性水肿、过敏反应、消化道反应等。本文就多西紫杉醇不良反应类型及临床上采取的预防和常规处理方法进行探讨。
  • 病例报告
    . 2002, 4(6): 404-404.
  • 病例报告
    Liang Xiaoli;Song Jianhua;Pei Yifang
    . 2007, 9(5): 367-368.
    An 83-year-old man with bile tract infection was given IV cefoperzone sodium and sulbactam sodium 2.0 g once in the daytime and 1.0 g once in the evening.Within six days of therapy,his platelet count progressively decreased from 164×109/L to 68× 109/L Cefoperzone sodium and sulbactam sodium was withdrawn and levofloxacin was given. One week later,the patient’s platdet returned to normal limits.
  • Zhang Xiaoying, Kong Yi, He Min
    . 2016, 18(1): 62.
    An 85-year-old woman with lung cancer received icotinib tablet 125 mg three times daily. Her platelet count (PLT) was 216×109/L before medication. On day 7 of administration, her PLT decreased to 107×109/L. On day 11, PLT decreased to 81×109/L, and 73×109/L on day 15. The patient was diagnosed as thrombocytopenia due to icotinib. Icotinib was stopped and Shengxuexiaoban capsule (升血小板胶囊) 1.8 g twice daily was given. Then her PLT was monitored closely. Twenty-four days after drug withdrawal, her PLT was 40×109/L. Forty-two days after drug withdrawal, her PLT returned to 153×109/L. On day 43 of drug withdrawal, the patient recovered to take primary dose of icotinib. The dosage of Shengxuexiaoban capsule increased to 1.8 g three times daily. On the third day of medication once again, the patient′s PLT was 132×109/L. The results of detection of PLT were normal after that.
  • Zhu Danyan
    Adverse Drug Reactions Journal. 2021, 23(6): 330-332. https://doi.org/10.3760/cma.j.cn114015-20201008-01006
    A 54-year-old male patient received furosemide, sacubitril and valsartan, trimebutine, and live combined bifidobacterium, lactobacillus and enterococcus capsules for heart failure, atrial fibrillation, abdominal distension, and diarrhea. The patient′s renal function was normal before medication and the serum creatinine (Scr) was 93-μmol/L. On day 2, due to the patient′s cough and sputum, paracetamol, pseudoepherine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate (containing 325-mg paracetamol, 30-mg pseudoephedrine hydrochloride, 15-mg dextromethorphan hydrobromide and 2-mg chlorphenamine maleate in each tablet) 325-mg orally were added once every 6 hours. On day 3, the patient developed dysuria and lower abdominal pain. Laboratory tests showed Scr 215-μmol/L and B-type natriuretic peptide 0.091-μmol/L; emergency ultrasonography of urinary system showed prostatic calculus, normal prostate size, and full bladder. Considering that paracetamol, pseudoepherine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate caused acute urinary retention and then acute kidney injury, the drug was stopped on that day and the other drugs were continued. On the 2nd day of drug withdrawal, the patient′s dysuria was relieved and Scr was 162-μmol/L; on the 3rd day of drug withdrawal, the patient′s symptoms disappeared and Scr was 134-μmol/L.
  • Guo Xiaodi, Li Wendong, Chen Jinglong
    Adverse Drug Reactions Journal. 2020, 22(7): 385-392. https://doi.org/10.3760/cma.j.cn114015-20200509-00515
    Objective To systematically evaluate the safety of immune checkpoint inhibitor ipilimumab combined with chemotherapy for advanced solid tumors. Methods Randomized controlled trials (RCTs) of ipilimumab combined with chemotherapy (the trial group) versus placebo combined with chemotherapy (the control group) for advanced solid tumors were collected by searching related databases (up to April 30, 2020). The outcome indicators were treatment-related adverse events (AEs), including fatigue, rash, nausea, diarrhea, neutropenia, alanine aminotransferase (ALT) elevation, and aspartate aminotransferase (AST) elevation. The methodological quality of studies was evaluated using the Cochrane collaboration risk of bias tool. RevMan 5.3-software and R software was used in meta-analysis and the effect values were expressed as relative risk (RR) and its 95% confidence interval (CI). Results A total of 5 RCTs (2 for non-small cell lung cancer, 2 for small cell lung cancer, and 1 for metastatic melanoma) were entered in this study, involving 2-532 patients, in which 1-335 patients were in the trial group and 1-197 patients in the control group. The results of quality evaluation showed that 5 RCTs were all high-quality studies. The results of meta-analysis showed that the incidences of treatment-related grade 1-5 AEs and grade 3-5 AEs in the trial group were significantly higher than those in the control group [87.27% (1-165/1-335) vs. 82.04% (982/1-197), RR=1.07, 95%CI: 1.03-1.10, P<0.001; 50.26% (671/1-335) vs. 37.68% (451/1-197), RR=1.40, 95%CI: 1.07-1.82, P=0.010]. However, the results of subgroup analysis showed that the difference in incidences of treatment-related grade 1-5 AEs and grade 3-5 AEs were statistically significant only in patients with metastatic melanoma between the trial group and the control group [98.79% (244/247) vs. 94.02% (236/251), RR=1.05, 95%CI: 1.02-1.09, P=0.005; 56.28%(139/247) vs. 27.89%(70/251), RR=2.02, 95%CI: 1.61-2.53, P<0.001]. The analysis of common AEs showed that the risks of rash, diarrhea, and liver injury increased in the trial group (all P<0.05) and the difference in treatment-related death between the 2 groups was not statistically significant [1.05%(14/1-335) vs. 0.42%(5/1-197),χ2=3.374, P=0.066]. Conclusion The risk of AEs in patients with advanced solid tumors treated with combination of ipilimumab and chemotherapy is higher than that with chemotherapy alone, especially the immune-related AEs, which deserves clinical vigilance.
  • 论著
    ZHU Rong-fei;CHEN Hao;WANG You-na;ZHANG Shu-chen;LIU Guang-hui
    . 2012, 14(4): 205-5.

    ObjectiveTo evaluate the efficacy and safety of concomitant use of mometasone furoate nasal spray and montelukast sodium chewable tablets in children with moderate to severe allergic rhinitis. Methods The subjects were selected from the children who were aged from 6 to 12 with moderate to severe allergic rhinitis and presented to outpatient department of Tongji Hospital, Tongji Medical College, Huazhong University of science and Technology from September 2011 to March 2012. According to the time order of treatment, the children were divided into the following 2 groups using randomized digital table: the combination therapy group and the mono-drug therapy group. The children were treated with mometasone furoate nasal spray 100 μg once daily plus one chewable tablet of montelukast sodium 5 mg once daily in the combination therapy group and mometasone furoate nasal spray alone 100 μg once daily in the mono-drug therapy group. The treatment course was 2 weeks in the 2 groups. On days 7 and 14 of treatment, the symptoms of allergic rhinitis were scored using 0-10 cm visual analogue scale, the adverse reactions were recorded, and the statistical analysis were performed in the 2 groups. ResultsA total of 252 children were entered in this study. The combination therapy group comprised 127 children, including 54 boys and 73 girls with average age of (8.1±2.6) years. The mono-drug therapy group comprised 125 children, including 58 boys and 67 girls with average age of (8.7±3.0) years. The differences in gender, age distribution,treatment course, general symptoms of allergic rhinitis, and single symptom of allergic rhinitis between the 2 groups were not statistically significant (P>0.05). Two children were withdrawn from the study due to joint pain, abdominal pain, and sleep disorders after the drug use. Compared with the scores before treatment, the scores of general symptoms of allergic rhinitis on days 7 and 14 of treatment decreased by (4.7±1.9) and (5.5±2.2) scores [(2.6±1.7) and (1.8±1.7) vs (7.3±1.3) scores] in the combination therapy group, (3.9±2.2) and (4.9±1.7) scores [(3.2±2.0) and (2.3±2.1) scores vs (7.2±1.5) scores] in the mono-drug therapy group. The differences before and after treatment in the 2 groups were statistically significant (P<0.05 for all comparison). The efficacy in the combination therapy group was better than that in the mono-drug therapy group(P<0.05). On days 7 and 14 of treatment, the efficacy for single symptom of runny nose or stuffy nose in children in the combination therapy group were better than that in the mono-drug therapy group (P<0.05 for all comparison). The differences in runny nose and stuffy nose scores between the 2 groups were statistically significant (P<0.05). The differences in sneezing and itchy nose scores between the 2 groups were not statistically significant (P>0.05). Five children presented with adverse reactions in the combination therapy group (3.9%); of them, mometasone furoate nasal spray-related adverse reactions were nasal bleeding (2 cases) and dry nose (1 case), and montelukast sodium chewable tablets-related adverse reactions were joint pain, abdominal pain (1 case), and sleep disorders (1 case). Four children (3.2%) in the mono-drug therapy group presented with adverse reactions, including 2 cases of nasal bleeding and 2 cases of dry nose. The difference in adverse reaction incidence between the 2 groups was not statistically significant (P>0.05). All adverse reactions in the 2 groups were mild, and resolved soon after drug withdrawal. No severe adverse reactions occurred in the 2 groups. ConclusionThe efficacy of the concomitant use of mometasone furoate nasal spray and montelukast sodium chewable tablets is better than that of mometasone furoate nasal spray alone. The combination therapy has a good safety.

  • 学术研究
    . 2005, 7(1): 5-7.
    昔布类药物塞来昔布和罗非昔布最初以其抗炎特点用于治疗类风湿关节炎和骨性关节炎,其疗效与对照的萘普生相当,但已显示出心血管不良事件增高的趋势。1999年以来,昔布类抗炎药物用于结、直肠腺瘤性息肉的防治。其中,罗非昔布25mg/d组的疗程超过18个月后,心脑血管事件发生率达3.5%,明显高于安慰剂组的1.5%。为此,该药于2004年9月30日从全球撤市;同样,塞来昔布也因以400mg/d和800mg/d防治腺瘤性息肉的临床研究中,当疗程平均达33个月时,与安慰剂对比,心血管事件的危险性分别增加2.5倍和3.4倍。为此,美国FDA于2004年12月17日发出紧急通告,停止塞来昔布原订5年的临床试验熏并要求用其他药品替代该产品。
  • 病例报告
    Yu Aihea;Nie Zhaohuab;Sun Guangb;Liu Lib;Xu Donglianb;Chen Guanghenga
    . 2008, 10(3): 205-2.
    Two patients with mental disorders died from renal failure following intravenous infusion of vancomycin for treating pulmonary infection. The first patient, an 84yearold man with mental disorders, underwent tracheotomy due to his pulmonary infection and respiratory failure. Initially, the glucocorticosteroids, ceftazidime, and etimicin were given to the patient, and subsequently changed to intravenous infusion of vancomycin 1 g twice daily. His Cr and BUN levels were 71 μmol/L and 7.3 mmol/L before vancomycin therapy, respectively, and increased to 223 μmol/L and 27.3 mmol/L on the day 9 of treatment, respectively. His urine volume decreased from 1 930 ml (on day 6 of treatment) to 650 ml (on day 8 of treatment). He developed pulmonary embolism, acute renal failure, metabolic acidosis, cardiac arrhythmia, and mild coma. Despite continuous resuscitation efforts, he died. The second patient, a 58yearold woman with mental disorders, was initially given cefepime, imipenemcilastatin, and low molecular heparin calcium, and subsequently changed to intravenous infusion of vancomycin 1.0 g twice daily for pulmonary infection. Her Cr and BUN levels were 87 μmol/L and 7.5 mmol/L before vancomycin therapy, respectively, and increased to 124 μmol/L and 14.7 mmol/L on day 3 of vancomycin therapy, respectively; and 436 μmol/L and 30.1 mmol/L on day 6 of vancomycin therapy, respectively. Her urine volume decreased to 900 ml on day 3 of vanconmcin therapy, and to 200 ml on day 6 of vancomycin therapy. She developed diarrhea. Acute renal failure was diagnosed. Vancomycin was discontinued. Despite continuous resuscitation efforts, she died on day 3 after vancomycin discontinuation.
  • 调查研究
    Dai Zhijun①;Wang Xijing①;Liu Xiaoxu①;Wu Wenying②;Ji Zongzheng③;Kang Huafeng①;Xue Fengjie①; Xue Xinghuan①
    . 2006, 8(4): 262-265.
    Objective:To evaluate the adverse effects of three different regimens in order to provide a basis for selection one of them used as neoadjuvant chemotherapy for local advanced breast cancer.Methods:During the period 2000-2005,a retrospective study was done for adverse effects and short-term efficacy to the three regimens in 89 patients with local advanced cancer.The 89 patients were assigned to 3 chemotherapy groups:CEF group(cyclophosphamide + epirubicin + fluorouracil,36 cases),NEF group(vinorelbine + epirubicin + fluorouracil,32 cases),TAC group(docetaxel + epirubicin + cyclophosphamide,21 cases),and treated with one of the three regimens for 2 cycles,every cycle was 28 d.Results:①The response rate(RR)of the breast primary tumor in CEF,NEF,and TAC groups was 47.2 %(17/36),71.9 %(23/32)and 85.7 %(18/21),respectively.The difference of response rate between CEF group and NEF group was significant(x2=4.251,P< 0.05)and so was between CEF group and TAC group(x2=8.292,P=0.004).But there was no difference between NEF group and TAC group(x2=1.386,P>0.05).② The adverse reactions of TAC group were leukopenia(21/21,100%),alopecia(21/21,100%),arthralgia or myalgia(12/21,51.1%),flash of face(9/21,42.9%)and hypersensitivity(4/21,19%).The incidence of leukopenia to TAC group was obviously higher than that in CEF group and NEF group.Thirteen of 32 cases in NEF group developed peripheral phlebitis(40%).Some other adverse reactions such as decreased hemoglobin level,thrombocytopenia,and gastrointestinal lesions were similar in the three group.Conclusion:NEF is an effective and tolerable regimen for treatment of patients with local advanced breast tumor.
  • 临床论著
    Li Weili;Ma Xiuyun;Wu Lu;Cai Haodong
    . 2010, 12(2): 77-6.
    Objective: To compare the efficacy and safety of longterm treatment with tebivudine versus lamivudine in patients with chronic hepatitis B. Methods: Thirty-nine patients with chronic hepatitis B in accordance with inclusion criteria were enrolled in the study from March 2004 to February 2005. Thirtynine patients were randomly divided into two groups and received doubleblind therapy: the tebivudine group (22 cases) and the lamivudine group (17cases). The tebivudine group comprised 18 men and 4 women with average age of (30.9±7.8) years and the patients were given tebivudine 600mg once daily for 104 weeks. The lamivudine group comprised 13 men and 4 women with average age of (30.4±8.5)years and the patients were given lamivudine 100mg once daily for 104 weeks. After 104 weeks, all patients in the two groups received openlabel tebivudine therapy and were given tebivudine 600mg once daily for another 104 weeks. The serum HBV DNA levels, complete response rates and ALT levels were measured every 8 weeks. The Seroconversion of HBeAg after 104 weeks of therapy and the viral breakthrough rates as well as the adverse reactions of tebivudine during the treatment were observed in the two groups. Results: In the tebivudine and lamivudine groups at weeks 52 and 104 of the doubleblind therapy, the complete response rates of HBV DNA were 72.2%(16/22)and 77.3%(17/22),47.1%(8/17)and 47.1%(8/17), respectively; the ALT normalization rates were 100%(22/22)and 86.4%(19/22),82.3%(14/17)and 76.5%(13/17), respectively. The HBV DNA breakthrough rates were respectively 4.5%(1/22), 18.2%(4/22), and 28.6%(6/21) in the tebivudine group at weeks 60, 104 and in year 3, but there was no increase in cases of breakthrough in year 4; the HBV DNA breakthrough rates were 23.5%(4/17)and 41.2%(7/17)respectively at weeks 52 and 104 in the lamivudine group. The levels of HBV DNA in 4 patients with lamivudine resistance in the two groups decreased to the lower limit of detectable value after treatment combined with adefovir for 8-24 weeks. Five patients experienced 9 episodes of elevated creatine kinase (CK) levels [(1 065~4 915)U/L] without muscle symptoms in the tebivudine group during the doubleblind therapy; and 6 patients experienced 9 episodes of elevated CK levels [(1 036~45 984)U/L] with muscle symptoms during the open-label tebivudine therapy. Conclusion: Telbivudine is more effective than lamivudine in the treatment of patients with chronic hepatitis B,and the drug is well tolerated.
  • 综述
    . 2003, 5(6): 366-370.
    本文对非肽类血管紧张素Ⅱ受体拮抗剂临床研究进展进行综述。非肽类血管紧张素Ⅱ受体拮抗剂除治疗高血压还具有治疗充血性心力衰竭,逆转左心室肥厚,预防动脉粥样硬化、偏头痛、房颤复律后复发,脑保护,肾保护,抗肿瘤等多面的作用,安全性高,具有广阔的发展前景。
  • Zhao Lei
    . 2016, 18(2): 116.
    ObjectiveTo analyze the adverse reactions and the correlative factor of zoledronic acid injection in postmenopausal osteoporosis patients.MethodsThe clinical data of postmenopausal osteoporosis patients who were hospitalized in endocrinology department of Xuanwu Hospital during October 2012 to May 2015 were collected. The patients′ age, with or without history of bone fracture, with or without receiving bone resorption inhibitors before treatment, the occurrence of adverse reactions including fever, influenza-like symptoms, headache, myalgia, arthralgia on day 3 and 14 after receiving zoledronic acid injection, and the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine (Scr) and urea nitrogen (BUN) before and 3 days after receiving zoledronic acid injection were recorded. The related factor of the above-mentioned adverse reactions was analyzed by multifactor logistic regression method.ResultsA total of 105 medical records of postmenopausal osteoporosis patients were enrolled into the study. The patients′ages ranged from 49-83 years, and the average age was (69±9) years. There were 17 cases with history of bone fracture, and 79 cases who received bone resorption inhibitors before treatment. All the patients received IV infusion of zoledronic acid 5 mg/100 ml. On day 3 after receiving zoledronic acid injection, the overall incidence of adverse reactions and the incidences of fever, influenza-like symptoms, headache, myalgia, and arthralgia were 45.7% (48/105) and 39.0% (41/105), 37.1% (39/105), 26.7% (28/105), 32.4% (34/105), 32.4% (34/105), respectively. On day 14 after receiving zoledronic acid injection, the overall incidence of adverse reactions and the incidences of fever, influenza-like symptoms, headache, myalgia, and arthralgia were 2.9%(3/105), 0, 0, 1.0%(1/105), 1.9% (2/105), 1.0% (1/105), respectively. The overall incidence on day 14 after receiving zoledronic acid injection was obviously lower than that on day 3(P<0.001). The difference of levels of patients′ ALT, AST, Scr, and BUN before medication and 3 days after medication were not statistically significant (all P>0.05). The result of multivariate logistic regression analysis showed that the age was negatively correlated with fever, influenza-like symptoms, and myalgia, and irrelevance to headache and arthralgia. Taking bone resorption inhibitors before receiving zoledronic acid injection was negatively correlated with the five kinds of adverse reactions mentioned above. The overall incidence and the above-mentioned five kinds of adverse reactions in patients age ≥ 60 years were lower than those in the patients aged<60 years (P<0.01, P<0.05, respectively).ConclusionsThe common adverse reactions of zoledronic acid injection in postmenopausal osteoporosis patients are fever, influenza-like symptoms, headache, myalgia, and arthralgia. The age and the history of receiving bone resorption inhibitors are negatively related to the above-mentioned adverse reactions.
  • Zhao Xixi, Wang Haifei
    . 2016, 18(4): 311.
    An 80-year old male patient, who had many kinds of diseases, received isosorbide mononitrate, irbesartan and hydrochlorothiazide, furosemide, spironolactone, and acarbose for more than 2 years and was added olanzapine 5 mg once daily because of sleep disorder. One month later, he developed bilateral lower limbs edema and half a month after that he developed right breast pain. Spironolactone was stopped. Four days later, the patient′s symptoms were not improved and color Doppler ultrasound examination of breast showed masculine mastoplasia. Olanzapine was withdrawn and 5 days later, his right breast pain and bilateral lower limbs edema relieved. Spironolactone and the above-mentioned drugs except olanzapine were given again. At 3 weeks of follow-up, the patient′s symptoms did not recur.
  • . 2015, 17(2): 117-120.
    ObjectiveTo explore the impact of pharmacist intervention on the potentially inappropriate drug application in the elderly patients in the primary health care institutions.MethodsTwenty four primary health care institutions in Beijing were selected. The researchers selected 15 kinds of potentially inappropriate drugs according to the Beers criteria and lists of potentially inappropriate drugs of USA, UK, and Japanese and organized a training of medication safety for pharmacists in above primary health care institutions. From February 10th, 2014 to February 20th, 2014, education on the risks of potentially inappropriate drug application in the elderly patients was carried out among the doctors in above mentioned institutions and relevant documents were distributed. Prescriptions for the elderly outpatients in the 24 primary health care institutions before (from June 3, 2013 to June 7, 2013) and after (from March 12, 2014 to March 16, 2014) the intervention were collected and the proportions of prescriptions containing 15 kinds of potentially inappropriate drugs in the prescriptions containing the appropriate diagnosis before and after the intervention were calculated and compared.ResultsThe number of collected prescriptions in the elderly patients before and after the intervention was 12 243 and 11 571, respectively. Before the intervention, there were 10 kinds of inappropriate drugs, including estazolam, diazepam, ibuprofen, diclofenac, belladonna, theophylline, aminophylline, chlorpheniramine, digoxin, compound reserpine triamterene, and glyburide. After pharmacist intervention, the proportions of prescriptions of 5 kinds of potentially inappropriate drugs in the elderly patients decreased significantly, including ibuprofen (5.92% vs. 27.43%), diclofenac (5.92% vs. 13.17%), chlorpheniramine(1.08% vs. 4.86%), digoxin (2.40%  vs. 7.56%) and glyburide (1.61% vs. 8.03%), all P<0.001.ConclusionPharmacist intervention has a positive effect on improving the potentially inappropriate drug application in the elderly patients.
  • 病例报告
    Zhu Wenjing;Ma Hong
    . 2014, 16(5): 316-3.
    A 37-year-old male patient received an intravenous infusion of compound glycyrrhizin injection 60 ml (containing 120 mg of glycyrrhizin) for reactivation of chronic hepatitis B. His symptoms improved markedly after 12-day treatment and the regimen was changed to oral compound glycyrrhizin tablets (containing 150 mg of glycyrrhizin, two tablets every time, thrice daily) and silymarin (140 mg, thrice daily). After 2 weeks of taking the medicines, the patient developed weakness of lower extremities and the symptom worsened gradually. After 25 days of taking the medicines, he presented with grade 3 muscle strength, hypomyotonia, a level of creatine kinase (CK) 8 378 U/L, and a level of potassium 2.2 mmol/L. Compound glycyrrhizin tablets and silymarin were discontinued, combined with the biopsy of musculus gastrocnemius, rhabdomyolysis and hypokalemia were diagnosed, and potassium chloride, reduced glutathione, and spirolactone were given. After 10-day treatment, he returned to grade 5 muscle strength, normal muscular tension, a level of CK 459 U/L, and a level of potassium 5.1 mmol/L. Three months later, the physical examination showed normal lower extremities and the levels of CK and potassium were respectively 156 U/L and 4.8 mmol/L.
  • Li Xiaole, Guo Wei, Xu Yongsheng
    Adverse Drug Reactions Journal. 2021, 23(1): 10-14. https://doi.org/10.3760/cma.j.cn114015-20200706-00744
    Objective To understand the clinical features of vancomycin-associated drug-induced hypersensitivity syndrome (DIHS) in children. Methods Case reports on vancomycin-associated DIHS in children were collected by searching the relevant databases home and abroad up to May 31, 2020. Patients′ relevant information (sex, age, primary disease, time from medication to onset of DIHS, main symptoms, organs and systems involved, hematological changes, RegiSCAR score, treatment and outcome) was extracted and descriptively analyzed. Results A total of 12 children with DIHS caused by vancomycin were enrolled in the study, including 10 males and 2 females. Their ages ranged from 22 months to 17 years, with a median age of 14 years. The median time from vancomycin exposure to occurrence of DIHS was 17 days, ranging from 5 to 35 days. The main clinical features were fever (12 patients, 100.0%), rash (12 patients, 100.0%), lymphadenopathy (8 patients, 66.7%), and mucosal injury (5 patients, 41.7%). Among the 12 children, 9 (75.0%) had liver injury, 4 (33.3%) had kidney injury, 2 (16.7%) had lung injury, 1 (8.3%) had spleen injury, and 1 (8.3%) had myocardial injury. Blood routine examination showed increased eosino- philia in the 11 children (91.7%) and increased atypical lymphocytosis in 5 children (41.7%). After the diagnosis of DIHS, vancomycin was discon-tinued in all the 12 children. After treatments with glucocorticoids, antihistamines, gammaglobulins, etc. (1 patient underwent liver transplantation), 11 children (91.7%) were improved and 1 (8.3%) died. Conclusions The clinical manifestations of DIHS caused by vancomycin in children are typical, mainly manifested by fever, rash, lymphadenopathy, etc. The damaged organs are mainly the liver, followed by the kidneys. Most of the children have a good prognosis, and a few may have severe organ damage leading to death.
  • 监测简报
    . 2004, 6(1): 52-53.
  • ADR咨询
    . 1999, 1(3): 178-178.
  • Zhou Hong
    Adverse Drug Reactions Journal. 2009, 11(6): 435-2.
    A 70yearold woman received tinidazole 2 g twice daily for two days. On day 3, amoxicillin 0.5 g thrice daily was added to the regimen. On the next day, the patient developed diarrhea with 3~6 bloody stools per day. Routine stool test showed RBC 200 cells/HP, WBC 10 cells/HP, occult blood (+); and enteroscope revealed pathological changes consistent with haemorrhagic colitis. Amoxicillin was stopped.Meanwhile fluid supplementation and symptomatic treatment were given, his condition became stable. Two weeks later, his symptoms improved obviously.
  • 安全用药
    Zhao Chengcheng;Yan Suying
    . 2011, 13(6): 363-4.
    Tigecycline is a new broad-spectrum antibiotic. This antibiotic is the first clinically available drug in glycyclines. It is structurally similar to tetracycline. Tigecycline is active against Gram-positive and Gram-negative bacteria and is used for treatment of complicated skin and soft tissue infections and complicated intra-abdominal infections. Generally, tigecycline less commonly causes acute pancreatitis. However, recent data indicate that tigecycline-induced acute pancreatitis has somewhat increased. The clinical presentation of tigecycline-induced acute pancreatitis is nausea, vomiting, abdominal pain, abdominal distension, and elevation in serum lipase and amylase levels. The mechanism of pancreatitis caused by tigecyclins remains unclear, but because of the structural similarity between tigecycline and tetracycline, it is plausible that tigecycline may be via the same mechanism as tetracycline to precipitate an acute episode of pancreatitis. If pancreatitis is considered to be caused by tigecycline, prompt discontinuation of tigecycline therapy is necessary. The management of tigecycline-induced pancreatitis includes administration of IV fluids, avoidance of food, and other symptomatic treatments. Clinicians should observe patients for signs and symptoms of pancreatitis, and monitor serum lipase and amylase levels during treatment with tigecycline.
  • 病例报告
    Du Jubaoa;Chu Yanqib;Guo Shuang;Qi Xiaolianb;Zhao Chenc
    . 2010, 12(6): 431-3.
    A 45yearold man received cefminox, monosialoteterahexosylganglioside, edaravone and gingko biloba flavonal glycosides for spinal injury and pulmonary infections after operation of cervical disc prolapse. One day later, cefminox was stopped, and the patient was given an IV infusion of imipenem/cilastatin sodium 0.5 g every eight hours. One day after this medication change, red rashes with pruritus appeared on his shoulder, neck, and chest. Three days later, his rash increased over large area of her skin, with confluence to sheetlike fashion. Red maculopapules occurred on back and inner side of the thighs which progressed to involve his both shanks and feet. Imipenem/cilastatin sodium was withdrawn and switched to an IV infusion of piperacillin sodium/tazobactam sodium 4.5 g 8hourly. No new rashes occurred ever since. However, his skin lesions continued to progress. He developed exfoliation, and sheetlike desquamation occurred. After symptomatic and supportive treatments, his skin symptoms improved.
  • ADR监测
    . 2004, 6(5): 340-341.
  • 病例报告
    Zhang Haiying;Shi Xiaowei;Li Yuzhen
    . 2009, 11(1): 53-3.
    A 59yearold man with hepatitis C was given IM interferon α1b 3,000,000u once every other day and oral ribavirin 300mg twice daily. After about six weeks of treatment, the man experienced severe dry cough and dyspnea. He had a temperature of 36.3℃ and a WBC of 7.72×109/L with N 0.82. Blood gas analysis revealed the following: PCO2 36 mmHg,PO2 48 mmHg and SaO2 87%. Chest Xray showed increased pulmonary markings over both lungs and a patchy nubilous shadow in lower field of right lung. Chest CT plain scan revealed bilateral lung diffuse effusion with atelectasis in lower lobe. Interstitial pneumonia was diagnosed. The patient’s adverse reaction was considered to be possibly interfereon and ribavirinassociated. The medications were discontinued. The patient was treated with azithromycin and ceftriaxone. His respiratory tract symptoms rapidly resolved one day later.
  • Liu Hengli, Li Xia, Yang Xinping, Yang Cuixian, Zhang Mi, Li Huiqin, Zhang Shuangmei, Wu Xingqian, Li Yuwei, Wang Haiyang
    Adverse Drug Reactions Journal. 2023, 25(1): 21-27. https://doi.org/10.3760/cma.j.cn114015-20220603-00491
    Objective To explore the clinical characteristics of tenofovir disoproxil fumarate (TDF)-related Fanconi syndrome (FS) in patients with HIV infection/AIDS (HIV/AIDS). Methods The medical records of patients with HIV/AIDS who were hospitalized in Yunnan Provincial Hospital of Infectious Diseases from December 2017 to February 2021, treated with antiretroviral therapy (ART) containing TDF, and diagnosed as FS were collected by searching hospital information system. Information such as gender, age, body weight, body mass index (BMI), ART treatment regimen and period, time of FS diagnosis, main clinical characteristics, results of laboratory test at admission and discharge, dual energy X-ray bone mineral density (BMD) test results, and interventions and outcomes were retrospectively analyzed. Results A total of 16 HIV/AIDS patients were diagnosed with TDF-related FS in the setting period, including 6 patients with complete FS and 10 with incomplete FS. FS were accompanied with chronic hepatitis C, hypertension, liver cancer, or depression in 7 patients. Sixteen patients received ART containing TDF for a minimum of 20 months and a maximum of 168 months with an average time of 68 months. The initial symptoms of FS were bone pain, fatigue, nausea, anorexia, polydipsia, polyuria, weight loss, etc. The time from initial symptoms to diagnosis of FS was 2 weeks at least, 24 weeks at most, with an average time of 7 weeks. Laboratory test results were as follows: all 16 patients had positive urine glucose under normoglycemic conditions and 14 patients had positive urine protein; 11, 11, 4, and 4 patients had low urine phosphorus, hypocalciuria, hypokalemia, and hyponatruria, respectively; 13, 12, 8, and 7 patients had hypophosphatemia, hypokalemia, hypocalcemia, and hyponatremia, respectively; 11 patients had serum creatinine increase; 10 patients had serum uric acid decrease; 1 patient had serum uric acid increase. Dual energy X-ray BMD detection was performed in 15 patients, of which 2, 2, and 11 patients had normal, reduced, and osteoporotic BMD, respectively. After diagnosis of TDF-related FS, 16 patients stopped using TDF immediately. After replacement of ART protocol without TDF and symptomatic treatment for an average time of 29 days, the above symptoms were alleviated, and some laboratory test indicators returned to the reference value range. The prognosis was good. Conclusions TDF-related FS mostly occurs within 68 months of drug use. The clinical symptoms of FS are nonspecific. Laboratory tests show that urine glucose is positive under normal blood glucose. Most of the patients have low blood phosphorus, low urine phosphorus, hypocalciuria, and osteoporosis. The prognosis is better after discontinuing TDF, replacing therapy with ART regimen without TDF, and giving symptomatic treatments.
  • 安全用药
    . 2001, 3(3): 162-164.
  • 抗菌药应用
    . 2005, 7(3): 196-202.
  • 病例报告
    Cheng Ruizhen;Yin Anning
    . 2007, 9(5): 328-328.
    A 22-year-old woman with infection received ceftazidime 3.0 g by intsavenous drip.One hour after the initiation of the infusion,she developed distending pain of toes,toothache,chest distress,and perioral numbness.The infusion was stopped immedia-tely.She was given antianaphylaxis therapy.About one and a half hour later,the symptoms resolved.
  • Wang Rui, Song Yanqing, Mao Lichao, Wang Xiangfeng
    Adverse Drug Reactions Journal. 2021, 23(1): 43-44. https://doi.org/10.3760/cma.j.cn114015-20191230-01082
    A 17-month-old female infant received combination chemotherapy with cisplatin, etoposide, and bleomycin (IV infusion of cisplatin 8.5-mg on day 1 to 5, IV infusion of etoposide 42-mg on day 1 to 5, IV infusion of bleomycin 6 units on day 1) after yolk sac tumor resection. Two weeks after finishing the chemotherapy, the child developed hearing loss. Her hearing thresholds evaluation showed 32 decibel for the left ear and 45 decibel for the right ear. Two women in her mother′s family were known to be with acquired deafness by questioning the family history. The results of deafness gene screening showed that the child was a carrier of the mitochondrion 12SrRNA gene m.1555A>G site homogeneous mutation, so it was considered that the hearing loss of the child was related to her deafness susceptibility gene and ototoxicity of cisplatin.
  • Han Jian, Zhang Liyun, Zhang Gailian, Xu Ke, Hou Ruihong
    . 2017, 19(5): 389.
    A 34-year-old female patient took by herself ibuprofen sustained-release capsules 300 mg orally due to systemic muscle trauma. One day later, diffused erythema papules occurred on her neck, gradually involving her eyes, mouth, nose, trunk and limbs, and accompanied by fever. The drug was stopped at the same day, but the symptoms were aggravated progressively. She was diagnosed with Stevens-Johnson syndrome. Glucocorticoids, human gamma globulin and symptomatic supportive treatments were given. Fourteen days later, the symptoms were improved and 30 days later, her body skin color returned to normal.
  • Wang Shuang, Wang Yu, Wen Ying
    . 2016, 18(6): 449.
    A 43-year-old male patient with HIV and HBV coinfection who had no underlying kidney disease received  antiviral  therapy, including  oral administration of tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg, and efavirdine 600 mg once daily. Thirty-three days after drug administration, the results of laboratory test showed the following volumes: serum creatinine (Scr)  134 μmol/L, blood  urea nitrogen (BUN) 7.0 mmol/L, creatinine clearance  62 ml/min. Tenofovir disoproxil fumarate was stopped and changed to zidovudine 300 mg twice daily. The other drugs were taken sequentially. On day 5 of tenofovir disoproxil fumarate  withdrawal, the results of laboratory test showed Scr 490 μmol/L, BUN 28.8 mmol/L, creatinine clearance 17 ml/min; on day 11 of tenofovir disoproxil fumarate  withdrawal, the results of laboratory test showed Scr  95 μmol/L, BUN 3.4 mmol/L, creatinine clearance 88 ml/min. He was diagnosed as reversible acute kidney injury induced by tenofovir  disoproxil fumarate. The results of  reexamination 6 months later showed Scr 56 μmol/L, BUN 2.8 mmol/L, creatinine clearance 148 ml/min.
  • 安全信息
    . 2014, 16(3): 131-1.
  • Zhang Yang, Shi Limin, Cheng Sheng, Luo Xiao, Wen Aiping, Liao Yin
    . 2015, 17(6): 408-411.
    ObjectiveTo evaluate the kidney′s safety of edaravone injection.MethodsThe clinical data of patients who were hospitalized in Neurology Department of Beijing Friendship Hospital, Capital Medical University from January 2014 to June 2014 and had complete medical records, aged ≥45 years and received edaravone injection for cerebrovascular disease were collected and analyzed retrospectively. The patients′ information, complications, time of application of edaravone injection (30 mg, twice daily, IV infusion), drug combination  and the levels of serum creatinine were recorded. The serum creatinine elevated to ≥26.4 μmol/L, or increased 1.5 times of baseline were the diagnostic criteria of kidney injury after receiving edaravone injection.ResultsA total of 237 patients′medical records comprised 163 male and 74 female, with average age of (65±9) years (50 to 86 years) were collected. The average time of edaravone injection administration was 11 days (2 to 26 days) for all patients. Eleven patients (4.6%) developed kidney injury. There was no statistical significance in the incidence of kidney injury between male and female patients[4.9% (8/163) vs.4.1% (3/74),P>0.05 for all comparisons]. The incidence of kidney injury in patients who were 75 years or older was higher than those in the patients who aged between 45 to 59 years and 60 to 74 years [11.4% (4/35) vs. 3.8% (3/80), 3.3% (4/122),P<0.05 for all comparisons]. The incidence of kidney injury in patients with chronic renal insufficiency or renal cyst was higher than that in patients without chronic renal insufficiency or renal cyst [9.1%(2/22) vs. 4.2%(9/215),7.7%(2/26) vs. 4.3%(9/211),P<0.05]. The average level of serum creatinine in the 11 patients before treatment was (68±24) μmol/L (26 to 113 μmol/L) and increased to (101±36) μmol/L (52 to 187 μmol/L) after receiving edaravone injection for 9 to 13 days (average days of 11). The serum creatinine levels of the 11 patients returned to the levels before administration after edaravone withdrawal. The 11 patients with kidney injury were all co-treated with three or more kinds of drugs. ConclusionsThe kidney′s safety of edaravone injection is higher in patients who were under 75 years, without chronic renal insufficiency and renal cyst. Dynamic monitoring of kidney function should be given in patients who are  75 years or older, with chronic renal insufficiency or renal cyst when receiving edaravone injection.
  • Qi Huaji, Ma Kuifen, Lyu Junhao, Zhou Qin, Peng Wenhan
    Adverse Drug Reactions Journal. 2021, 23(4): 216-218. https://doi.org/10.3760/cma.j.cn114015-20201116-01143
    A 55-year-old male patient with a history of hypertension and type 2 diabetes mellitus received sodium phosphates oral solution 45-ml diluted in 750-ml or more warm water in 2 divided doses for bowel cleansing on the night before and the morning of the day of colonoscopy. After the colonoscopy, the patient developed abdominal distension. Eighteen days after the colonoscopy, elevated serum creatinine (Scr) was found with a peak value of 175-μmol/L. Thirty-five days after the colonoscopy, Scr was 168-μmol/L and the glomerular filtration rate calculated by the plasma-creatinine-based equations Chronic Kidney Disease Epidemiology Collaboration was 38.54-ml/min. Renal puncture and pathological examination showed tubular epithelial cell injury with calcium phosphate deposits, and acute phosphate nephropathy was diagnosed. The patient was advised to drink more water and was given symptomatic treatments such as diuretic furosemide. Five months later, the Scr recovered to 105-μmol/L.
  • 实验论著
    Luo Jia;Wang Huiji*
    . 2009, 11(6): 391-6.
    ABSTRACTObjective: To study the protective effects of glutamine on nonsteroidal antiinflammatory durg (NSAID)induced smallintestinal mucosal lesions in rats in order to provide the basis for safe drug use. Methods:Ninety SPF grade male SpragueDawley rats were randomly allocated into nine groups: the 4 model groups, the 4 protection groups, and the 1 empty control group. Each group comprised ten rats. The rats in the 4 model groups were given indomethacim 2.5 mg/kg, aspirin 50 mg/kg, ibuprofen 30 mg/kg, and celebrex 20 mg/kg twice daily for 14 days, respectively. The rats in the 4 protection groups were given abovementioned four different kinds of NSAIDs, meanwhile glutamine 100 mg/kg was given at the same time, respectively. All drugs were dissolved in 2 ml of sodium carbaxymethycellulose ( CMC ), which was passed into the stomach. The rats in the empty control group were given 2 ml of CMC. On day 15, all rats were sacrificed. The depth and area of rats’smallintestinal mucosal lesion were measured with the CMIAS multifunction color image analytical system, and the accumulative depth and area of the lesions were calculated. The myeloperoxidase (MPO), malondialdehyde( MDA ), superoxide dismutase (SOD), nitric oxide (NO) levels in the smallintestinal homogenate were measured. Results: In the indomethacin, aspirin, ibuprofen, and celebex model groups, the accumulative depth of smallintestinal mucosal lesions was 5 954, 511, 1 361, and 1 447 μm, respectively, the accumulative area of smallintestinal mucosal lesions was 1 956 592, 164 304, 339 711, and 445 611 μm2, respectively. The differences were statistically significant in all the model groups compared with the empty control group except the aspirin group (all P<0.05 ). The severity of lesions in the indomethacin group was greater than that in the other model groups( P<0.05 ). In the indomethacin, aspirin, ibuprofen, and celebrex protection groups, the acumulative depth and area of smallintestinal mucosal lesion were 1206, 443, 616, and 723 μm as well as 390 450, 92 192, 209 655, and 238 827 μm2,respectively. Their severity of lesions was markedly lower than that of the model groups. In the indomethacin, aspirin, ibuprofen, and celebrex protection groups, the MPO levels were (1.10±0.35),(0.53±0.19),(0.83±024),and(0.37±0.17)U/g; and in the corresponding model groups, the MPO levels were (2.37±0.63),(1.66±0.50),(1.35±035), and(1.14±0.38)U/g. The MPO levels in the protection groups were markedly lower than those in the corresponding model groups. The differences were statistically significant (all P<0.05 ). The MDA levels in the indomethacin protection group were markedly lower than those in the indomethacin model group[(0.50±0.16)vs(1.19±0.77)nmol/mg, P<0.05)]. The SOD levels in the indomethacine, aspirin, ibuprofen, and celebrex model groups were respectively (3.53±0.64),(4.03±1.28),(3.44±1.05), and(3.70±1.53)U/mg, which were markedly lower than those in the empty control group[(5.49±1.09)U/mg, all P<0.05)]. The SOD levels in the corresponding protection groups were respectively(4.03±1.28),(4.46±1.10),(4.29±1.53), and(4.00±1.08)U/mg, which were higher than those in the model groups, but there were no statistically significant differences. There were no statistically significant differences in the NO levels between the protection groups and model groups (P>0.05). Conclusion: Glutamine has protective effects on NSAIDinduced smallintestinal mucosal lesions in rats.
  • Gao Bei;Liu Fang;Zhang Jun
    . 2011, 13(6): 354-5.
    Objective: To investigate the clinical characteristics, related factors, as well as prevention and treatment of phlebitis associated with an infusion of alprostadil. Methods: Beijing Adverse Drug Reactions Monitoring Network database from 2003 to 2010 was searched for reports of phlebitis associated with an infusion of alprostadil. The patient’s gender, age, family history and past history of phlebitis, primary disease, dosage form of alprostadil, route of administration, dosage, duration of treatment, time to phlebitis onset after drug administrations, clinical manifestations, severity of phlebitis, management and prognosis were analyzed. Results: A total of 246 reports with of phlebitis associated with alprostadil were collected. These patients comprised 167 men with average age(66.7±16.1)years and 79 women with average age (68.1±12.3) years. Of the 246 patients, 23 patients had past history of phlebitis and 5 patients had family history of phlebitis. The main primary diseases were neurological disease(92 cases, 37.4%), surgical disease(26 cases, 10.6%), and cardiovascular disease(25 cases, 10.2%). Percentage of 99.2(244 cases) of patients received alprostadil injection and 0.8% (2 cases) of patients received alprostadil powder for injection. The alprostadil injection dosage was 10 μg/d for 87.3% (213 cases) of patients and 20 μg/d for 86% (21 cases) of patients. The dosage of alprostadil power for injection was 10 μg/d for 0.8% (2 cases) of patients. The administration of drug was as follows: 97.2% (239 cases) of patients were treated with alprostadil by IV infusion and 2.8% (7 cases) of patients were injected with alprostadil intravenously. The median of duration of treatment were 2 days. The median of time to phlebitis onset after drug administration was 20 minutes. When the severity of phlebitis was determined according to the criteria of Intravenous Nurses Society (INS), 145 patients (66.5%) had grade 1, 57 patients (26.1%) had grade 2, and 15 patients (6.9%) had grade 3 phlebitis. The main clinical manifestations were erythema and pain in injection-site with formation of a strip and cordlike mass of the vein. There were no significant differences in gender, age, administration route, dosage, and treatment duration between patients with grades 1 and 2 phlebitis and patients with grade 3 phlebitis (P>0.05 for all comparisons). The measures of management included drug withdrawal, topical application of medications, a slower infusion rate, a change of injection site, an IV infusion of alprostadil diluted with 0.9% sodium chloride. In 203 reports with description of prognosis, 124 patients were cured and 79 improved. Conclusion: The intravenous administration of alprostadil can induce phlebitis. It’s severity is relatively mild and prognosis usually is good after immediate drug discontinuation and/or symptomatic treatment.
  • 调查研究
    Wang Yurong;Zhao Xiaohui;Shi Ailan;Li Yong
    . 2001, 3(1): 21-25.
    Objective: To analyse ADR due to compound formulas. Methods: The ADR types, clinical findings and related drugs were presented in 285 cases of 1994 - 1998 in BMA General Hospital. Results: 75 cases with ADR resulted from 35 compound formulas accounting for 26.3% , with 12 organs or systems involved. Among them 21.3% had ADR history and 36% showed moderate or severe symptoms. Conclusion: Compound formulas can be the cause of ADR and the pharmacovigilance needs strengthening.
  • 论著
    Luo Leiming;Fan Li;Liu Jing;Liu Yu;Zhang Minghua;Liu Guoshu
    . 2005, 7(1): 11-14.
    Background: The roles of statins on first or second prevention of coronary heart disease by lipid-lowering or non-lipid-lowering effects were widely identified. Statins can improve prognosis of patients with various cholesterol levels-which is relied on long-term continuing therapy. Objective: By analyzing appearance of simvastatin therapy compliance and its affecting factors-the study would supply evidence for promotion of statins intervention. Methods: Unstable angina patients with average cholesterol levels were chosen to receive simvastatin for secondary prevention of coronary heart disease. The therapy compliance-drug adverse reactions and reasons of non-compliance were investigated and followed up. Results:The simvastatin therapy compliance in 3-6-and 18 months was respectively 68.9%-48.0%-40.0%-with a significant lowering in the first 6 months. The clinic types of unstable angina and patient's age showed no influence on therapy compliance-but compliance of high-risk patients was in a low level. The causes of non-compliance were dut to patient's poor knowledge for lipid control levels in high-risk condition and non-lipid-lowerigng effect of statins-and consideration of financial burden-etc. Conclusion: In second prevention of cardiovascular events with simvastatin in unstable patients with average cholesterol levels-there is a low level of therapy compliance. It is very important for physicians to improve compliance of patients for statins therapy.
  • 安全用药
    . 2003, 5(1): 23-26.
  • 调查研究
    Guo Lizhu
    . 2004, 6(4): 231-235.
    Objective: To investigate the agents, pathogenesis and management of liver impairment induced by traditional Chinese patent medicines (TCPM). Methods:103 hospitalized cases with TCPM-induced hepatitis in 1991-2003 were retrospectively analysed. Results: TCPM-induced hepatitis was mainly due to drugs for osteoarthropathy, followed by drugs for dermatoses. And clinical presentation was mostly hepatocellular damage and cholestasis. Improvement and recovery were achieved most part of patients treated with drugs for liver disorders. Conclusion: Hepatitis can be induced by TCPM, especially those for osteoarthropathy and dermatoses, which may suggest the hepatotoxicity or prescription incompatibility in the above drugs.
  • Yan Xing, Xu Yuan, Lin Na
    Adverse Drug Reactions Journal. 2020, 22(5): 289-294. https://doi.org/10.3760/cma.j.cn114015-20200226-00174
    To observe the influence of intranasal dexmedetomidine premedication on general anesthesia effect and safety in pediatric patients undergoing monocular fundus examination for the first time. Methods Pediatric patients with monocular retinoblastoma (RB) who underwent fundus examination under the general anesthesia for the first time in Beijing Tongren Hospital, Capital Medical University from October 2018 to April 2019 were divided into the dexmedetomidine group and the control group by random number table method, each group comprised 30 cases. Before entering the operating room, the children in the dexmedetomidine group received intranasal dexmedetomidine 2-μg/kg and 0.9% sodium chloride injection 0.02-ml/kg in the control group, respectively. Thirty minutes later, the children were transferred to the operation room. Their heart rate and pulse oximetry saturation (SpO2) were monitored and recorded. The children in the 2 groups were anesthetized with 8% sevoflurane inhaled through a mask and then placed into a laryngeal mask for maintenance anesthesia by inhaling 2%-3% sevoflurane. Spontaneous breathing was retained during the operation. The heart rate and SpO2 before nasal administration drip (T0), 30-minutes after nasal drip (T1), at the time of laryngeal mask placement (T2), at the beginning of operation (T3), and at the time of laryngeal mask removal (T4) and retention time in post anesthesia care unit (PACU) were compared between the patients in the 2 groups. The children′s separation status from parents when entering the operation room were evaluated by the Parental Separation Anxiety Scale (PSAS), the emergence agitation degree in PACU were evaluated by the Pediatric Anesthesia Emergence Delirium (PAED) scale, and the level of sedation of children at consciousness recovery in PACU were evaluated by Ramsay score. Results The differences of children′s general condition, SpO2 at different time points, and the retention time in PACU between the 2 groups were not statistically significant (P>0.05 for all). Except T0, the heart rates at time points of T1-T4 in the dexmedetomidine group were lower than those in the control group, and the differences were statistically significant (P<0.05 for all). Compared with those in the control group, the children in the dexmedetomidine group were more easily separated from their parents when entering the operation room; the PSAS score was lower [(2.40±0.81) vs. (2.93±0.87), P=0.018]; the incidence of restlessness during the consciousness recovery period was lower [ (16.7%, 5/30) vs. (63.3%, 19/30), P<0.001]; Ramsay score was higher [(3.2±0.7) vs. (1.9±0.6), P<0.001]; and PAED score was lower [6 (2, 12) vs. 12 (5, 8), P<0.001]. Conclusions Intranasal dexmedetomidine premedication can reduce children′s anxiety degree of separation from parents when entering the operation room and the incidence of emergence agitation during recovery period after general anesthesia, and did not prolong the retention time in PACU. It is suggested that intranasal dexmedetomidine premedication is effective and safe in general anesthesia for ultra-short daytime ophthalmological ambulatory surgery in children.
  • Zhou Huting, Liu Pengcheng, Yao Dongning
    Adverse Drug Reactions Journal. 2024, 26(10): 620-626. https://doi.org/10.3760/cma.j.cn114015-20240428-00289
    The Vaccine Adverse Event Reporting System (VAERS) in the United States is the earliest vaccine safety surveillance system in the world, established in 1990. The VAERS database can be used to detect new, unusual, or rare adverse events following vaccine to identify potential safety issues with marketed vaccines. This paper introduces the basic situation and data acquisition methods of VAERS database, summarizes the format, content, relevance and practical application methods of VAERS data packet, and reviews the research on vaccine safety data analysis and signal mining by foreign scholars using VAERS data in recent years, so as to provide reference for Chinese scholars in use of VAERS database and the data opening of surveillance data of suspected adverse event following immunization in China.
  • Li Xiaoxiao, Yi Zhanmiao, Zhao Rongsheng, Liu Fang, Huang Runzhou
    . 2015, 17(3): 209.
    ObjectiveTo explore application value of PDCA cycle method in intravenous (IV) infusion speed management in inpatients.MethodsPatients hospitalized in the 2nd ward of Department of Neurology, Peking University Third Hospital were selected as subjects and IV infusion speed standards were drown up using a quality improvement management, Plan-Do-Check-Action (PDCA) cycle method. Before and after the management, data related to IV infusion speeds from May 20th to 26th, 2013 (before management) and May 12th to 18th, 2014 (after management) and adverse drug reactions/events (ADR/ADE) evaluated absolutely, probably, or possibly related to drugs from August 2012 to May 2013 (before management) and August 2013 to May 2014 (after management) were collected, the qualified rates of IV infusion speeds and ADR/ADE rates were calculated.ResultsThere were 40 beds of ward of department of Neurology. During May 20th to 26th , 2013, 33 kinds of injections were used in patients (255 person-time), and 11 kinds of injections (belonged to 7 types, 184 person-time) were selected as pilot injections for IV infusion speed management. The qualified rates of IV infusion speed were 82.4%-100.0% and the average IV infusion speed was 94.6%±6.7%. During May 12th to 18th , 2014, 39 injections were used in patients (721 person-time). Among them, 11 pilot injections were used in patients (483 person-time), the qualified rates of IV infusion speed were 85.7%-100.0% and the average IV infusion speed was 96.6%±5.1%. The qualified rate of IV infusion speed after IV infusion speed management increased than that before IV infusion speed management, but difference between them was not statistically significant (P>0.05). A total of 145 cases of ADR/ADE which were evaluated absolutely, probably or possibly related to drugs were collected. Of them, 49 cases of ADR/ADE were related to IV infusion speed, including 22 cases before IV infusion speed management (accounted for 36.1% of 61 cases of ADR/ADE  during the same time) and 27 cases after IV infusion speed management (accounted for 32.1% of 84 cases of ADR/ADE during the same time). As for the ADR/ADE involved in 11 pilot injections, 3 cases occurred before management (accounted for 4.9% of 61 cases of ADR/ADE during the same time) and 4 cases occurred after management (accounted for 4.7% of 84 cases of ADR/ADE during the same time).ConclusionApplication of PDCA cycle method may improve quality of IV infusion speed management in inpatients and increase medication safety management level.
  • 综述
    Wang Wanqing;Miao Liyan
    . 2014, 16(4): 237-5.
    Irinotecan is a chemotherapeutic agent widely used in the treatment of gastrointestinal cancer and small cell lung cancer. The common adverse reactions of irinotecan are delayed onset diarrhea and neutropenia. These adverse reactions are associated with genetic factors and non-genetic factors. Genetic factors include genetic polymorphisms of various enzymes and transporters, such as carboxylesterase, liver uridine diphosphate glucuronosyltransferase 1A, and cytochrome P450 3A4. Non-genetic factors including age, smoking, and drug combination can also affect the susceptibility of irinotecan and metabolism of drugs. Providing an individualized treatment according to different genotypes can improve clinical response of irinotecan and decrease the incidence of adverse reactions.
  • 安全用药
    Li Yunjing;Li Xueqin
    . 2010, 12(6): 415-4.

    Prolonged use of total parenteral nutrition(TPN) may induce intestinal complications. The clinical presentations of intestinal complications are abdominal pain, diarrhea, nausea, vomiting, water and electrolyte disturbance, and even a shock. The mechanisms of TPNinduced intestinal complications might be associated with atrophy intestinal mucosa and intestinal barrier damage, leading to bacterial overgrowth and translocation. The preventive measures for TPNinduced intestinal complications are as follows: the duration of TPN use should be decreased if possible; TPN should be combined with enteral nutrition as early as possible. Alanylglutamine,growth hormone, and some other nutritional factors can be added to solutions for TPN in patients who were prolonged use of TPN.

  • Jin Qiaofeng
    Adverse Drug Reactions Journal. 2009, 11(5): 371-2.
    A 29-year-old woman with suspected ectopic pregnancy received an IM methotrexate 80 mg after undergoing a diagnostic curettage. One week later, an IM methotrexate 80 mg was readministrated for continuing increase in blood β-HCG level. On the day of injection, the patient developed lumbago, nausea, and vomiting. On the fifth day, she presented with fever, sore throat, generalised skin rash, and mouth ulcer. On the eleventh day, routine blood testing revealed following levels and values: WBC count 1.0×109/L, Hb 106 g/L, PLT count 138×109/L, ALT 267.3 U/L, AST 183.3 U/L, γ-GT 166.9 U/L. Filgrastim, reduced glutathione, fluid supplement, and symptomatic treatment were given. The count of white blood cells and platelet decreased further. Subsequently. Bone marrow aspiration showed megakaryocyte dysmaturity. Laboratory examination revealed following levels: CK 39 U/L, CK-MB 3.2 U/L, ALT 70.2 U/L. Symptomatic treatment was given. Reexamination on her liver function was normal. Her status became stable and she was discharged.
  • 中毒救治
    Wang Dixin;Li Suyan;Xue Changjiang
    . 2007, 9(5): 346-348.
    Four patients(3 men and 1woman aged 19~51 years)developed acute thallium poisoning.The clinical presentations were the triad of gastroenteritis,polyneuropathy,and alopecia.Their urine thallium concentration was 885~7 143 μg/L.The four patients were treated with Prussian blue 250 mg/kg daily,and hemoperfusion was added to their regimen in three of them.Later,the patient's symptoms were relieved and their urine thallium concentration decreased to 0.01~216 μg/L
  • 调查研究
    Liang Bing;Zhou Guangyou;Yin Ling;Zhang Han
    . 2004, 6(2): 85-87.
    Objective:To investigate the liver disorders in connection with tr ad itional Chinese patent medicines(TCPM).Method:During1998-2000,liv er disorders caused by TCPM were analysed in41patients with different disease s.Results:Icterus,symptoms of alimentary system and abnormal liver function occured in all patients.Withdrawal of TCPM and start of liver-protective thera py made liver function normalized within1-4weeks.Conclusion:Hepatic reactio ns to TCPM were re-ported increasingly and great importance should be attached to it.
  • 药物评介
    . 2000, 2(4): 268-270.
  • 专题讲座
    . 2002, 4(2): 114-119.
  • 论著
    Cao Chuanmei;Ma Xiuyun;Cai Haodong
    . 2006, 8(2): 92-97.
    Objective: To observe the efficacy and safety of adefovir for treating HBeAg positive chronic hepatitis B. Methods: A randomized, double-blind and placebo-controlled trial was performed. Forty patients were selected and adefovir was administered orally in a dose of 10 mg daily. The effects of adefovir on the level of serum hepatictis B virus(HBV) deoxyribonucleic acid(DNA), alanine aminotransferase(ALT) and e antigen/e antibody seroconversion were observed. The adverse reactions to the drug were monitored. Results: The 132 weeks of treatment and observation to 37 patients were accomplished. The outcomes showed that HBV DNA level reduced, and ALT level returned to within normal range. The e antigen/e antibody seroconversion rate was elevated gradually with the continued use of the drug. Follow-up observations lasting 36 weeks found no recurrence in the cases (6 patients) who were complete response over half a year and discontinuation of the drug. The life quality of the patients was improved during the treatment. The adverse reactions were slight. Conclusion: Adefovir is an effective and safe medication for treating HBeAg positive chronic hepatitis B.
  • 病例报告
    Zhai Yinghui;Li Haitao
    . 2009, 11(6): 436-3.
    Two patients with hypertension developed gingival hyperplasia after administration of nifedipine. Patient 1, a 43yearold man, recevied nifedipine 10 mg twice daily. After 5 years of therapy, the patient developed of gingival papilla enlargement accompanied by hyperemia of gingival margin. Nifedipine was withdrawn and changed to candesartan cilexetil. One months later, his symptoms improved.Patient 2, a 78yearold woman, was treated with nifedipine 30 mg once daily due to poor control of hypertension. After one year of the therapy, the patient experienced of gingival papilla enlargement with mild hyperemia. Nifedipine was discontinued and switched to amlodipine. Two weeks later, her symptoms relieved.
  • 病例报告
    Liu Jinxian;Liang Xiuyan
    . 2007, 9(4): 284-285.
    An 82-year-old man,suffering coronary heart disease and hypertension for many years,was hospitalized for treatment.He started receiving amlodipine 5 mg once daily.A week later,he developed lower limbs oedema.Fifteen days later,he developed anasarca further.Examination revealed him pleural and pericardial effusion.In consideration of cardia insufficiency,his amlodipine dosage was increased to 5 mg twice daily.The next day,his anasarca aggravated rapidly.Amlodipine was discontinued.Then he was administered nifedipine controlled-release tablets 30 mg once daily and frusemide 20 mg twice daily.Two days later,his oedema relieved gradually.After one month,the patient's oedema resolved completely and he was discharged.Five months later,the patient was admitted again for hypertension(180~170/120~100 mmHg).The dose of nifedipine controlled-release tablets was increaded to 30 mg twice daily.Twenty days later,he developed oedema of eyelid and lower limb again.An ultrasonic cardiography showed mil…更多d pericardial effusion.Nifedipine controlled-release tablets was decreased to 30 mg once daily,and frusemide 20 mg twice daily was added to his regimen.Three days later,the oedema resolved gradually.The patient recovered and was discharged after 3 weeks
  • 安全用药
    Ren Zhenwen;Zhou Ying;Cui Yimin;
    . 2010, 12(3): 188-6.
    Ibutilide is a class Ⅲ antiarrhythmic used in the treatment of atrial fibrillation or flutter. One of the serious adverse reactions to ibutilide is arrhythmias, manifested as QT interval prolongation and torsade de pointes ( TdP ). The time to TdP onset is within 1 hour after drug administration. The mechanism of ibutilideinduced TdP may be related to the repolarization abnormalities. The measures of prevention and treatment of ibutilideinduced arrhythmias are as follows: if arrhythemias occures, the drug showed be withdrawn immediately, electrical cardioversion, isoprenaline and atropin injections, potassium and magnesium supplements as well as beta blockers should be given; electrolyle abnormalities should be corrected before treatment strart; concomitent use of ibutilide with other antiarrhythmics should be avoided; ECG monitoring should be carried out during ibutilide treatment; Ibutilideinduced arrhythmics is liable to occure in women than men, and caution is needed when using ibutilide in women.
  • Lin Lu*, Chen Wenying, Hong Xiaofeng, Zhang Xiaojuan, Yang Min
    . 2015, 17(4): 304.
    A 43-year-old man with type 2 diabetes was treated with an intravenous (IV) infusion of piperacillin-tazobactam (4.5 g dissolved in 0.9% sodium chloride for injection 100 ml, every 8 hours) for diabetic foot gangrene. There were pain, ulceration and purulent secretions on his right foot back before treatment. His body temperature was 36.8 ℃. Laboratory test before the treatment showed the following values: white blood cell count (WBC) 11.5×109/L, neutrophil 0.73, eosinophils 0.02, C-reactive protein (CRP) 104.0 mg/L. On day 4 of treatment, the symptom of his foot was alleviated, the purulent secretion from foot was reduced. Laboratory test showed that  WBC was 9.4×109/L, neutrophil 0.61, eosinophils 0.03. On day 12 of treatment, laboratory test showed that WBC was 6.1×109/L, neutrophil 0.60, eosinophils 0.04. On day 14 of treatment, the patient had high fever (41.2 ℃), laboratory test showed the following values: WBC 3.4×109/L, neutrophil 0.58, eosinophils 0.11, CRP 11.3 mg/L, erythrocyte sedimentation rate 86 mm/1 h, procalcitonin 0.08 μg/L. The patient was diagnosed as late-onset drug fever due to piperacillin-tazobactam. On day 15, piperacillin-tazobactam was stopped. Forty-eight hours after drug withdrawal, his body temperature decreased to 36.8 ℃. The results of reexamination of routine blood test showed almost normalized values: WBC 9.8×109/L, neutrophil 0.70, eosinophils 0.04.
  • Guo Ruipeng, Zhang Guoxiang
    Adverse Drug Reactions Journal. 2020, 22(7): 416-417. https://doi.org/10.3760/cma.j.cn114015-20190410-00352
     A 46-year-old female patient with rheumatoid arthritis received oral folic acid 10-mg thrice daily for nutritional megaloblastic anemia. About 8-minutes after the first administration, the patient developed itchy skin all over the body, followed by diffuse macular papules on the head, face, limbs, and trunk. Considering the immediate anaphylaxis caused by folic acid, folic acid was discontinued and chlorp- henamine 4-mg was given orally. However, her skin symptoms were aggravated, followed by shortness of breath, chest tightness, nausea, and etc. Symptomatic treatments with dexamethasone, 10% calcium gluconate, promethazine, and oxygen inhalation were given immediately. Forty minutes later, her itchy skin was relieved; 5 hours later, the rashes subsided; and 7 hours later, the allergic symptoms disappeared. After 3 days of treatment with chlorphenamine, folic acid desensitization treatment was performed. Then no adverse reactions recurred and the patient′s anemia was gradually improved. The patient continued to took oral loratadine and folic acid. At 1 month of follow-up, she had no discomfort, and the laboratory tests showed hemoglobin 113.5-g/L. Drugs were stopped and the patient was instructed to visit the department of rheumatology for the treatment of rheumatoid arthritis.
  • Liao Wenjian, Luo Yonghang, Li Yudong, Su Yong
    Adverse Drug Reactions Journal. 2023, 25(3): 180-182. https://doi.org/10.3760/cma.j.cn114015-20220515-00426
    A 49-year-old female patient took febuxostat 20-mg once daily orally due to chronic kidney disease and hyperuricemia. On day 9 of medication, the patient developed facial hot flashes, and then purplish red maculopapules gradually appeared on the head, face, trunk, and both lower limbs. The rash were aggravated and spread gradually all over the body, involving the eyes, mouth, and vaginal mucosa. Lysis blisters appeared at the waist, and the area of epidermalysis was less than 10%. Laboratory tests showed white blood cell count 2.1×109/L, neutrophil count 1.7×109/L, hemoglobin 59-g/L, platelet count 97×109/L, C-reactive protein 105.6-mg/L; serum creatinine 1-062-μmol/L, and uric acid 647-μmol/L; human leukocyte antigen B*5801 allele was positive. Severe erythema multiforme induced by febuxostat was considered. Febuxostat was stopped immediately and treatments including protective isolation care, methylprednisolone, immunoglobulin, hemodialysis combined with hemoperfusion were given. On day 16 of treatments, black scab was found on the lip mucosa, and 30% skin scab peeled off. After 19 days of treatments, most of the scabs of whole body fell off, and new skin was visible. Laboratory tests showed that white blood cell count and platelet count returned to normal, C-reactive protein was 2.41-mg/L, serum creatinine was 582-μmol/L, and uric acid was 424-μmol/L.
  • . 2015, 17(2): 84-86.
  • 论著
    Xue Hao①;Luo Leiming②; Peng Yingxin①;Liu Guoshu②
    . 2004, 6(4): 226-228.
    Objective: To investigate the effects of carvedilol on vascular endothelial function and insulin resistance in hypertensive patients with type 2 diabetes mellitus. Methods: Following discontinuation of any cardiovascular drugs for 2 weeks, 41 patients with arterial hypertension and diabetes mellitus were divided randomly into carvedilol group(21cases) and metoprolol group(20 cases). Before treatment and after 6 months of treatment, fasting glucose and insulin were measured. Insulin sensitivity index was calculated. Reactive congestion and nitroglycerin-induced dilation of the brachial artery were assayed with high-resolution ultrasound. Results:After 6 months of treatment, carvedilol significantly reduced blood pressure. Fasting insulin was reduced and insulin sensitivity index was increased significantly. Reactive congestion and nitroglycerin-induced vasodilatation were improved. And after 6 months of treatment with metoprolol, fasting blood sugar and insulin was increased and insulin sensitivity index was reduced slightly. Reactive congestion and nitroglycerin-induced vasodilatation were not improved. Conclusion: Carvedilol effectively reduced blood pressure and improved insulin resistance, endothelial-dependent vasodilatation and endothelial-independent vasodilatation in hypertensive patients with type 2 diabetes mellitus.
  • 安全用药
    . 2001, 3(3): 164-168.
  • 论著
    Luo Leiming;Fan Li;Xue Hao;Yang Xue;Shi Jun;Zhu Bing;Ye Ping
    . 2005, 7(6): 408-411.
    Objective: To estimate the tolerance and safety of carvedilol on chronic heart failure(CHF) patients with chronic renal dysfunction(CRD). Methods: 68 CHF patients with CRD were chosen to receive carvedilol therapy in addition to sufficient anti-heart failure treatment including digitalis ACE inhibitors and diuretics. The carvedilol was given from 6.25 mg to 37.5 mg each day and the course of treatment lasted six months. The tolerance and adverse effects of carvedilol were investigated. Results: Carvedilol is well tolerated for all 68 CHF patients with CRD being under treatment through the end of study. Carvedilol significantly improved cardiac output and renal filter function. 22 patients reached the target dose of 37.5mg/day, and the average dose tolerated by patients was 25.2 mg/day. The incidence of adverse effects occurred in 19 cases most of them were minor and reversible and only 4 of them were serious and needed urgent management. Conclusion: The third generation of beta-blocker carvedilol could improve cardiac and renal function in chronic heart failure patients with chronic renal dysfunction. Moreover it is safe and tolerant.
  • 不良事件
    . 2005, 7(5): 389-389.
  • 论著
    Fu Qi;Ma Xiuyun;Xu Yanli
    . 2004, 6(3): 154-156.
    Objective: To investigate whether bradycardia is related with ribavirin treatment in SARS patients. Methods: 181 cases with SARS were retrospectively enrolled and divided into two groups in this case-control study, that is, ribavirin group (ribavirin and basic therapy) and control group (basic therapy only). Results: Compared with control group, ribavirin therapy decreased the SARS patients' heart rate (p< 0.05) at 0-3 days and OR was 4.1(1.59-10.55). Conclusion: When given by intravenous infusion, ribavirin caused a dose-related bradycardia in SARS patients
  • 安全用药
    Cai Haodong
    . 2009, 11(5): 346-5.
    Peripheral neuropathy is defined as a damage of the peripheral motor nerve , sensory nerve, and autonomic nervous system. Recently, peripheral neuropathy caused by combination therapy with telbivudine and interferon has been sometimes reported, and the incidence is 16.7%. The time to onset of peripheral neuropathy during combination with telbivudine and interferon is 4.5 months. Telbivudine plus interferon-induced peripheral neuropathy manifests as mononeuropathy or polyneuropathy, and it mainly is sensory nerve damage. Diagnosis of peripheral neuropathy is based on clinical manifestation, the results of electromyography and nerve conduction velocity tests. Peripheral neuropathy must be distinguished from myopathies which could be produced by telbivudine. Telbivudine combined with interferon should be avoided in clinical practice as much as possible. If peripheral neuropathy caused by telbivudine plus interferon is confirmed, both drugs should be stopped.
  • 论著
    Liu Jia;Shao Jianping;Yan Nan;Zhu Hua;Luo Can
    . 2014, 16(1): 22-5.

    ObjectiveTo explore the problem of anticoagulation therapy in hospitalized patients with atrial fibrillation and obtain evidences for safer anticoagulant therapy in clinical practice.MethodsThe medical records of patients with non-valvular atrial fibrillation who were hospitalized in Department of Cardiology, Northern Jiangsu People′s Hospital from January 1 to August 31, 2013 were collected and analyzed retrospectively. The patients were evaluated after risk stratification of thromboembolism and the risk of hemorrhage by CHADS2-VASc score and HAS-BLED score according to the 2010 ESC Guidelines for Management of Atrial Fibrillation. The main indicators of analysis included the patients′ risk stratification of thromboembolism, the score of risk of hemorrhage, the situation of applying anticoagulant, international normalized ratio (INR), hemorrhagic complication, thromboembolic events, and the compliance with medication in patients who received different therapeutic regimen of atrial fibrillation (ventricular rate control and rhythm control).ResultsA total of 134 patients were enrolled into the study, including 69 male and 67 female with an average age of(67±14)years (20 to 91years). The number of patients whose CHA2DS2-VASc score 0, 1, and ≥2 were 11, 23, and 100, respectively. The number of patients whose HAS-BELD score ≥3 was 13. The patients who received the ventricular rate control and the rhythm control therapy were 85 and 49, respectively. Among the 85 patients who received the rate control treatment, there were 1,12,72 cases whose CHA2DS2-VASc scores were 0, 1, and ≥2, respectively. One patient with CHA2DS2-VASc score 0 received aspirin. Two, 8, and 2 patients with CHA2DS2-VASc score 1 received warfarin, antiplatelet drug (only aspirin, only clopidogrel or both), and did not receive any anticoagulants (one patient had contraindication), respectively. There were 2 patients who received only clopidogrel developed multiple focal cerebral ischemia as shown by head CT examination in the 8 patients who received antiplatelet drugs. Thirty-three, 35, and 4 patients with CHA2DS2-VASc score≥2 received warfarin, antiplatelet drug and did not receive any anticoagulants, respectively. The cases number of INR <2.0, 2.0-3.0, and >3.0 were 25, 7 and 1 respectively in patients who received warfarin on discharge. The average CHA2DS2-VASc score and HAS-BLED score in 49 patients who received the rhythm control therapy were (2.3±1.8) and (1.3±1.1), respectively. Twenty-five patients received warfarin. The number of INR <2.0, 2.0-3.0, and >3.0 were 17, 5 and 2 respectively in patients who received warfarin on discharge. One patient did not monitor INR. Fifteen of 134 patients developed cerebral infarction. Among them, 8 patients (53.3%) received warfarin and none achieved INR standard on discharge.ConclusionsThe main problems of anticoagulation therapy in hospitalized patients with atrial fibrillation are the lower rate of receiving warfarin therapy and the lower intensity of anticoagulation treatment. Unnecessary concern of clinicians about hemorrhagic complication is the main reason of irregular anticoagulant therapy.

  • 病例报告
    Zhou Xianghong;Li Ling;Wu Hong
    . 2007, 9(5): 374-375.
    A 46-year-old woman with herpes zoster and a 22-year-old man with post-closed thoracic drainage received tramadol 100 mg twice daily for unbearable pain.After 1 to 2 days of administration,they developed urinary frequency as many as 20 to 30 times every day.Their total urine volume per day increased obviously.Physical examination and urine routine test found no abnormality.After the cessation of tramadol,their urinary frequency disappeared.
  • 专题讲座
    . 2004, 6(6): 401-405.
  • 监测交流
    . 2005, 7(2): 143-144.
  • 中毒救治
    . 2002, 4(3): 173-175.
  • 调查研究
    He Suiping;Liang Jianhua;An Yuan
    . 2002, 4(1): 11-13.
    Objective: To analyze adverse drug reactions and its related factors in 94 elderly patients. Method: ADR reporting forms over years of our hospital were collected and reviewed. Results: 1 .Patients with ADR over 60 years old accounted for 39.5% of all ADR forms, occuring more in male than in female. 2.Clinical manifestations of dermoreaction and nervous system reaction were demonstrated, ranking the first and second respectively on the ADR order list. 3. Most drugs of inducing ADR were for the treatment of cardiac cerebral - vascular diseases and infectious diseases. Conclusion: Occurrence of ADR in the elderly is in the close relation with their original diseases and the combined use of drugs.
  • Adverse Drug Reactions Journal. 2021, 23(6): 335-336. https://doi.org/10.3760/cma.j.cn114015-20210610-00670
  • 综述
    . 1999, 1(1): 1-7.
    本文概述了我国建国50年来抗高血压药物的发展和使用状况,结合国外资料,重点对利尿剂、β受体阻滞剂、钙拮抗剂、血管紧张素转换酶抑制剂,以及血管紧张素Ⅱ受体阻滞剂进行了再评价,旨在为临床医师和药师提供较好的、合理用药的信息。
  • Tian Zhaolong;Li Yanhong;Wang Tianlong
    Adverse Drug Reactions Journal. 2009, 11(6): 428-2.
    A 43yearold man underwent an operation for pain in both lower limbs after spinal cord impairment. His blood pressure was 157/100 mm Hg after admission and 110/70 mm Hg after anesthesia induction during surgery. Subsequently, the patient was given an IV infusion of ceftriaxone 2 g dissolved in 100 ml of sodium chlorid 0.9% after he was turned over from dorsal position to prone position. Several minutes later, his blood pressure dropped to 60/40 mmHg and his heart rate was 100 beats/min. Electrocardiogram revealed an inverted T wave. Postural hypotension was considered and his condition improved after management. The surgery was completely uneventfully. His vital signs were stable after operation. On day 2, the patient received an IV infusion of ceftriaxone again. After infusion of 10 ml, he experienced generalized itching, chest distress, polyhidrosis, and dyspnea suddenly. Physical examination showed a BP of 70/40 mm Hg, a heart rate of 130 beats/min, and a SpO2 of 0.80. Ceftriaxone was withdrawn immediately and antiallergic treatment, fluid expansion, and antishock therapy were given. Finally, his symptoms disappeared and blood pressure returned to within normal range.
  • 药物评介
    Sun Ying;Pan Qi
    . 2007, 9(3): 220-224.
    Insulin glargine produced by recombinant DNA technology is a recombinant human insulin analog that is a long-acting blood-glucose-lowing agent. The effect profile of insulin glargine was relatively constant with no pronounced peak, and the duration of its effects was prolonged (up to 24 hours). This profile allows once-daily dosing as a normal basal insulin, the principal adverse reaction to insulin glargine is hypoglycemia, but lower incidence of nocturnal hypoglycemia is more apparent with insulin glargine compared with some other insulin preparations.
  • Huang Wenhui, Xie Fenghua, Xu Xiaoxin, Fei Yan
    . 2017, 19(1): 37-43.

    ObjectiveTo evaluate the risk of urinary tract infection (UTI)and upper respiratory tract infection (UPI) induced by saxagliptin 5 mg/d.MethodsThe related databases were searched (until June 2016) for randomized controlled trials (RCTs). The RCT about the risk of urinary tract infection and upper respiratory tract infection induced by saxagliptin between the patients with type 2 diabetes using saxagliptin 5 mg/d alone or with other hypoglycemic agents (test group) and the patients using placebo (control group) were collected. The main outcome of all RCTs  were UTI and URTI rates. The literature was in Chinese and English only. The data and the quality of the enrolled literature was extracted and evaluated, respectively. The soft ware RevMan 5.3 was used for the Meta-analysis. The results were expressed as relative risk (RR) and 95% confidence interval (CI).ResultsA total of 16 reports which included 17 RCTs comprised 6 236 patients [3 226 cases in the test group (T), 3 010 cases in the control group (C)] with a course of treatment from 12 to 206 weeks were enrolled into the Meta-analysis. The studies on the risk of UTI and URTI which were induced by saxagliptin 5 mg/d comprised 6 088 patients (T: 3 152, C: 2 936) and 4 851 patients (T: 2 461, C: 2 390), respectively. The studies about the risk of UTI and URTI which were induced by saxagliptin 5 mg/d plus metformin comprised 1 741 patients (T: 879, C: 862). The results of quality evaluation of 16  articles showed 13 of Grade A and 3 of Grade B. Meta-analysis showed that there were no significant differences between saxagliptin 5 mg/d monotherapy or combined with other antidiabetic drugs and the placebo in the risk of UTI [6.66% (210/3 152)vs. 5.82% (171/2 936), RR=1.15, 95%CI: 0.94-1.40, P=0.17) and URTI [8.00% (197/2 461) vs. 7.66% (183/2 390), RR=1. 04, 95%CI: 0.86-1.26, P=0.71)]. There was no significant difference between saxagliptin 5 mg/d combined with metformin and the placebo in the risk of URT [7.17% (63/879) vs. 6.15% (53/862), RR=1.16, 95%CI: 0.82-1.65, P=0.40].ConclusionThe results of this study shows that there is no evidence of saxagliptin 5 mg/d to increase the risk of UTI and URTI in patients with type 2 diabetes mellitus.

  • Li Huibo, Tang Huilin, Ding Shigang, Zhao Rongsheng
    . 2017, 19(2): 113-120.
    ObjectiveTo systematically evaluate the relationship between proton pump inhibitors (PPI) and the risk of fractures.MethodsThe related databases were electronically searched for the cohort studies and the case-control studies about the relationship between proton pump inhibitors and the risk of fractures from inception to July 12, 2016. Meta-analysis were conducted using RevMan 5.3 softwear. The results were presented as odds ratio (OR) or relative risk (RR) and 95% confidence interval (CI). The evidence quality of the enrolled literatures were evaluated by Grades of Recommendation, Assessment, Development, and Evaluation.ResultsA total of 20 reports which were related to 21 studies involving 9 cohort studies, 12 case-control studies and 2 076 154 subjects were enrolled in the study. There were 262 298 cases who used PPI and 1 813 856 cases who did not use PPI in the 2 076 154 subjects. The pooled results of Meta-analysis of cohort studies showed that compared with the subjects who had not used PPI, the risk of fracture increased 85% in the subjects who used PPI (OR=1.85, 95%CI: 1.55-2.21, P<0.000 01); the risk of hip fracture increased 58% (OR=1.58, 95%CI: 1.07-2.33, P<0.000 01);the risk of fracture in the subjects who were ≥50 years old increased 58% (OR=1.58, 95%CI: 1.47-1.70, P<0.000 01). The pooled results of Meta-analysis after combination of case control studies showed that compared with the subjects who had not used PPI, the risk of fracture increased 39% in the subjects who used PPI (OR=1.39, 95%CI: 1.26-1.52,  P<0.000 01); the risk of hip fracture increased 45% (OR=1.45, 95%CI: 1.23-1.69, P<0.000 01); the risk of fracture in the subjects who were ≥50 years old increased 43% (OR=1.43, 95%CI: 1.14-1.79, P=0.002). There were no explicit dose-effect relation and time-effect relation between PPI and hip fracture. The risk of fracture in female and male patients who used PPI increased 110% and 88% as compared with those in female and male patients who never used PPI (OR=2.10, 95%CI: 1.50-2.92, P=0.000 1; OR=1.88, 95%CI: 1.14-3.11, P=0.01), respectively. The result of quality evaluation by GRADE showed that the risk factors (including fracture, hip fracture, female, male, and the patient’s age 50-years or older) which increased the degree of fracture after PPI use were all very low quality evidences.ConclusionPPI use modestly could increase the degree of risk of all kinds of fracture and hip fracture, especially in females.
  • Yang Zhonghui, Tan Haihong, Shen Dandan
    . 2016, 18(4): 316.
    A 37-year-old male patient received nimesulide 0.1 g twice daily because of lower back pain. The platelet count was 155×109/L before the drug use. On day 4 of treatment, petechiae appeared and did not disappear after pressing. Nimesulide was stopped by himself. On day 5, the platelet count was 3×109/L. An IV infusion of gamma globulin and large dose of methylprednisolone were given. Three days later, his platelet count was 108×109/L and petechiae decreased. One month later, his platelet count was 125×109/L and petechiae disappeared.
  • 相互作用
    Cui Ying;Liu Zhijun;Fu Dexing
    . 2007, 9(3): 186-189.
    Patients with thromboembic disease and moderate pains usually receive warfarin plus tramadol for the anticoagulation and relief to the pain. Recent studies indicate that tramadol can enhance warfarin’s anticoagulation which may increase the international normalized ratio(INR) and the risk of hemorrhage. If it is necessary to combine the two drugs in clinical practice, the dosage of warfarin should be reduced in order to avoid the life-threatening adverse reactions.
  • 临床论著
    Li Dishan;Chen Haiping
    . 2009, 11(6): 381-5.
    Objective: To study the related factors for antimicrobialassociated diarrhea (AAD) in hospitalized elderly patients. Methods: A prospective study was conducted from January 2007 to June 2008, 163 elderly patients were hospitalized with pulmonary, biliary, and urinary infections. The patients comprised 132 men and 31 women aged 65~103 years [average (82±7) years]. Antimicrobials were infused intravenously and the prescribed dosage was given according to the drug label. When using a certain antimicrobial to treat different patients, the drug was used with the same dosage, but the treatment course varied. The relationship between AAD and some factors, including the patients' age, duration of hospitalization, medical intervention( such as nasal feeding, intubation and mechanical ventilation, indwelling catheter) , the kinds of antimicrobial agents, and treatment course, was analysed. Results: Of the 163 patients, 48 developed antimicrobialassociated diarrhea. The incidence was 29.4%. Diarrhea occurred in 2~26 days after receiving the medicine. Nineteen patients had diarrhea with <5 stools per day. Twentynine patients had diarrhea with ≥5 stools per day. Loose stools and watery stools were commonly seen, and mucous stools and bloody purulent stools with abdominal pain and abdominal distention were seldom observed. The incidence of diarrhea in patients aged <80 years and those aged ≥80 years was 25.5% (13/51) and 31.3%(35/112), respectively. The difference was not statistically significant (P>0.05). The incidence of AAD in patients with <30 days of hospitalization and those with ≥30 days of hospitalization was 17.8% (19/107) and 51.8%(29/56), respectively. The difference was statistically significant (P<0.001). The incidence of AAD in the patients undergoing medical intervention and those undergoing no medical intervention was 78.9%(15/19) and 22.9%(33/144), respectively. The difference was statistically significant (P<0.01). The incidence of AAD in patients receiving 1, 2, and ≥3 kinds of antimicrobials was 13.3%(11/83), 29.4%(15/51), and 75.9%(22/29), respectively. The differences were statistically significant when the incidences were compared with each other (P<0.05,P<0.01). The antimicrobial agents which induced high incidence of AAD were cefoperazonesulbactum (42.9%), clindamycin (40.0%),amoxicillinclavulanate potassium and piperacillintazobactam (35.7%). The incidence of AAD in the patients receiving <7 days, 7~15 days, and > 15 days of drug therapy were 14.3%(4/12), 20.8%(15/72), and 46.0%(29/63), respectively. Logistic multiregression analysis showed that combined use of antimicrobials and the medical intervention were independent risk factors for ADD. Conclusion: The elderly patients are prone to develop antimicrobialassociated diarrhea and its related factors include the kinds of antimicrobials, multiple drug therapy, prolonged drug use, and medical intervention. Close monitoring the AAD occurring should be performed in the elderly patients receiving antimicrobials.
  • 论著
    Bai Yao;Duan Jingli
    . 2011, 13(4): 205-8.
    Objective: To evaluate the efficacy and safety of liposome encapsulated paclitaxel (LEP) in the treatment of patients with non-small-cell lung cancer (NSCLC). Methods: Medline, Embase, PubMed, Wanfang,CNKI database (from 1980 to 31 July 2011),Cochrane systematic evaluation and controlled trials register in Cochrane Library (Issue 2,2011) were searched. The randomized controlled trials (RCT) of LEP therapy compared with paclitaxel (PTX) in patients with NSCLC were collected. According to the inclusion criteria, the articles were selected, evaluated, and meta-analyzed. The treatment efficiency and the incidence of adverse reactions between LEP and PTX in patients with NSCLC were compared and their results were presented in relative risk (RR) or odds ratio (OR) with 95% confidence interval (CI). Results: A total of 1057 related articles were searched and 11 RCT were selected according to the inclusion and exclusion criteria. A total of 627 patients were entered in this study. Of them, 329 patients were in the LEP group and 298 patients were in the PTX group. The results of meta-analysis showed that the differences in the treatment efficiency between the LEP and the PTX groups were not significant (RR=1.16,95% CI:0.93-1.46,P=0.19); the differences in the incidence of leukopenia, thrombocytopenia, anemia, hair loss between the 2 groups were not significant (P>0.05). The incidence of nausea and vomiting, rash, myalgia, peripheral neuritis, and dyspnea were lower in the LEP group than in the PTX group, their OR (95% CI) were 0.48 (0.33-0.69), 0.17 (0.08-0.40), 0.23 (0.15-0.35), 0.41 (0.21-0.81), and 0.18 (0.06-0.50), respectively; the differences were significant (all P<0.01). Conclusion: LEP is similar to PTX in efficacy, but LEP is safer than PTX.
  • 病例报告
    LONG Ming-li
    . 2012, 14(1): 57-3.

    A 50-year-old male with pulmonary infections received levofloxacin, as a result of poor effect, was ready to switch to cefoperazone sodium and tazobactam sodium. About 10 minutes after a skin allergy test was carried out, the patient experienced chest distress, palpitations, shortness of breath, dyspnea, heart rate was 120 beats/min. Cefoperazone sodium and tazobactam sodium-induced anaphylactic reactions was considered, dexamethasone 10 mg was given by IV bolus immediately and underwent electrocardiogram monitoring. His symptoms such as chest distress, shortness of breath, and dyspnea were improved 1.5 hours later. Blood gas analysis indicated:PCO2 26 mm Hg, PO2 47 mm Hg, HCO3- act 19 mmol/L, HCO3- std 22 mmol/L, pH 7.49. After 8 hours, the symptoms of allergic reactions subsided.

  • 病例报告
    ZHAO Jing;KE Hui-xing;ZHANG Ai-ling;WANG Dan-dan;YANG Li-ping
    . 2013, 15(2): 102-3.
    A 74-year-old male patient received latamoxef, biapenem, moxifloxacin, teicoplanin, vancomycin hydrochloride, linezolid, and daptomycin in succession for about one month of cough, expectoration, and fever after resection of rectal cancer. Teicoplanin was changed to moxifloxacin after 12 days of teicoplanin treatment. On day 4 of moxifloxacin treatment, the patient developed congestive rash and itching on his limbs and trunk. Moxifloxacin was stopped and changed to vancomycin hydrochloride as well as anti-allergic treatment, and then the rash improved. On day 8 of vancomycin hydrochloride treatment, the patient developed rash again on his limbs. Vancomycin hydrochloride was withdrawn and changed to teicoplanin. On day 5 of teicoplanin treatment, more rash occurred and some of them developed vesicles on the surface and fused into lamella. Linezolid was given and anti-allergic treatment was continued. Old vesicles were absorbed gradually and no new vesicles reoccurred. Teicoplanin-induced delayed-type hypersensitivity was considered. Cross allergies caused by vancomycin hydrochloride and teicoplanin could not be excluded.
  • 调查研究
    Liu Guiyang;Yu Fengying;Chen Chao;Ma Liang;Wang Yuyu
    . 2010, 12(6): 397-4.
    Objective: To compare the adverse reactions of amoxicillin and amoxicillin/clavulanate potassium in order to provide a reference for safe drug use in clinical practice. Methods: The adverse reaction reports associated with amoxicillin and amoxicillin/clavulanate potassium from database of PLA Adverse Drug Reaction Monitoring Center between march 2000 and march 2010 were collected and retrospectively analyzed. The reported cases were divided into two groups: the amoxicillin group and the amoxicillin/clavulanate potassium group. The clinical manifestations, outcomes, and severity of adverse reactions, the influences of adverse reactions on the primary diseases, and the time to adverse reaction onset were compared between the two groups. Results: A total of 576 adverse reaction reports associated with amoxicillin and amoxicillin/clavulanate potassium were collected. Of the reports, 438 adverse reaction reports associated with amoxicillin involved 814 adverse reactions, and 138 adverse reaction reports associated with amoxicillin/clavulanate potassium involved 233 adverse reactions. The amoxicillin group comprised 220 men and 218 women with a mean age of (36.4±19.0) years, and the amoxicillin/clavulanate potassium group comprised 62 men and 76 women with a mean age of (40.4±20.9) years. The percentages of skin and appendages disorders, gastrointestinal system disorders, circulatory system disorders, and central nervous system disorders occurring in patients in the amoxicillin and amoxicillin/clavulanate potassium groups were 77.4%(n=630) vs 55.8%(130) , 5.3%(43) vs 19.7%(46) , 1.3%(11) vs 4.3%(10), and 1.3%(11) vs 4.3%(10), respectively. The percentages of cases of nonserious and serious adverse reactions in the two groups were 92.5% (405 cases) vs 97.8% (135 cases) and 7.5% (33 cases) vs 2.2% (3 cases) , respectively. As to the influence of adverse reactions on primary diseases in the two groups, the percentages of marked and no marked influences were 9.1% (40 cases) vs 1.4% (2 cases), 90.9% (398 cases) vs 98.6% (136 cases), respectively. The differences between the 2 groups in all above indexes were statistically significant (All P<0.05). The median time to adverse reactions onset in the two groups were 3 days and 1 day, respectively. Conclusion: The clinical use of amoxicillin/clavulanate in treating infectious diseases appears to be relatively safe compared with amoxicillin.
  • 病例报告
    Wu Sanlan;Chen Dongsheng
    . 2014, 16(5): 303-2.
    A 45-year-old woman received an intravenous injection of levofloxacin (0.4 g, once daily), Suhuangzhike (苏黄止咳) capsules (3 capsules, thrice daily) by mouth, and montelukast sodium (10 mg at bedtime, once daily) by mouth for acute attack of chronic bronchitis. About 30 min after the first administration of montelukast sodium, the patient developed numbness of extremities and tremor, dyspnea, and generalized weakness, followed by nausea and vomiting and the symptoms lasted for about 2 hours without alleviating. Montelukast sodium was discontinued, levofloxacin and Suhuangzhike capsules were applied continuously, and symptomatic treatments were given at the same time. The numbness of extremities and tremor and dyspnea relieved, nausea and vomiting did not recur until 16 ∶ 00 of the following day.
  • 临床论著
    Wang Gang;Liu Aiyong;Gao Wenbin;Wang Wulong;An Hongliang
    . 2010, 12(1): 1-4.
    Objective: To explore the clinical safety of weekly singleagent paclitaxel chemotherapy plus three dimensional conformal radiotherapy in treatment of elderly patients with locally advanced nonsmall cell lung cancer(NSCLC). Methods: A multicentre, openlable trial was performed. From January 2006 to December 2008, 56 patients with stage Ⅲ NSCLC were enrolled in this study. They comprised 39 men and 17 women with age of 60~78 years and the mean age was 67 years. These 56 patients included squamous carcinoma (36 patients), adenocarcinoma (20); Ⅲa stage NSCLC (34) and Ⅲb stage NSCLC(22). An intravenous infusion of paclitaxel 40 mg/m2 was given once a week, followed by 3D-CRT(6MV-X ray, 95%PTV/60Gy/2Gy/30f) once daily 3 hours after paclitaxel infusion completion. The duration of treatment was 6 weeks. The changes in primary focus and mediastinal lymphatic metastasis as well as adverse reactions and survival situation were recorded during treatment and in week 2 after treatment completion. Results: All 56 patients completed 6week therapy. The total effective rate to primary focus of NSCLC was 821%(46/56) and the total effective rate to mediastinal lymphatic metastasis was 91.1%(51/56). The total effective rate to primary foci of squamous carcinoma and adenocarcinoma was 88.9%(32/56) and 70.0%(14/20), respectively, and the total effective rate to mediastinal lymphatic metastasis of squamous carcinoma and adenocarcinoma was 97.2%(35/36) and 80.0%(16/20), respectively. There was no statistically significant difference among different types of pathology. Acute adverse reactions to chemotherapy were mainly bone marrow suppression, the incidence of a reduction of white cells, hemoglobin, and platelets were 42.9%(24/56), 51.8%(29/56), and 30.4%(17/56), respectively, and the incidence of nausea and vomiting were 42.9%(24/56). Acute adverse reactions to radiotherapy were mainly radiationinduced esophagitis and pneumonia, and their incidence was 17.9%(10/56) and 58.9%(33/56), respectively. All the adverse reactions mentioned above in the patients with squamous carcinoma and adenocarcinoma were mild. The mean time to disease progression was respectively 7.8 months and 5.6 months, the mean survival time was respectively 11.3 months and 10.2 months, oneyear survival rate was respectively 47.2% and 35.0%, and twoyear survival rate was respectively 25.0% and 15.0%. Conclusion: Weekly singleagent paclitaxel chemotherapy plus 3D-CRT has better shortterm efficacy and safety in treatment of elderly patients with locally advanced NSCLC.
  • ADR术语
    . 2004, 6(5): 353-354.
  • Xu Huia;Xu Qianqianb;Tong Xuhui;RuNinga;Zhang Yana
    Adverse Drug Reactions Journal. 2009, 11(4): 262-2.
    A 29-year-old man developed paraphasia and abnormal behaviors after taking a total of 20 paracetamol (0.5 g) tablets within one day. After admission, laboratory tests revealed the following values: ALT 26 U/L, AST 16 U/L, BUN 43 mmol/L, SCr 235 μmol/L, and blood glucose 4.2 mmol/L. The next day, he presented with a coma and his blood glucose was 1.2 mmol/L. Symptomatic treatment was given. Two weeks later, his blood glucose level and renal function were return to within normal ranges.
  • 安全用药
    Nan Fei;Dang Haihong
    . 2009, 11(3): 183-5.
    Hepatitis C is an infectious disease caused by hepatitis C virus. Treatment of hepatitis C viral infection is mainly to use interferon or interferon plus ribavirin. Depression may occur in the patients with hepatitis C following treatment with interferon. The time of depression onset is 1-8 weeks after starting interferon. The prevalence rate of interferon-induced depression is 17%-82%. The risk factors for depression occurring include patients' heredity, neuropsychic condition before interferon treatment, hepatitis C itself, and the dosage, duration, administration route, and formulations of interferon. The mechanisms of interferoninduced depression are decreased 5-HT levels, hypothalamic-pituitary-adrenocortical (HPA) axis activation, proinflammatory cytokine activation, increased intercellular adhesion molecule-1, increased nitric oxide levels, and decreased dipeptidyl peptidase levels. Treatment and prevention of depression include assessment of patient condition before treatment and appropriate choice of anti-depression drugs after depression occurring.
  • 不良事件
    . 2006, 8(3): 223-223.
  • 调查研究
    Li Yanhan;Luo Leiming;Zhang Ling
    . 2002, 4(5): 297-298.
    Objective: To investigate the influence of digoxin treatment on R - R intervals in the elderly with continuous atrial fibrillation. Method: Concentration of plasma digoxin, frequency of long R - R intervals and pattern of atrioventricular conduction in response to synchronized cardioversion were observed in 84 cases after administration of digoxin. Results: Small doses of digoxin could decrease the ventricular rate and long R- R intervals appeared in 37 cases, accounting for 44 percent. No cases were with second-degree atrioventricular block after the cardioversion. Conclusion: Small doses of digoxin showed the safe and effective control over the ventricular rate. The long R- R intervals may be associated with increased atrioventricular junctional concealed conduction induced by digoxin' s parasympathominetic effect rather than its overdose use. So it would not be considered as an indicator of the withdrawal of the drug.
  • Sun Qi, Zhang Yaming
    . 2015, 17(6): 462-463.
    A 88-day-old boy was vaccinated with the acellular pertussis, diphtheria, tetanus, inactivated poliomyelitis, hemophilus influenza type b conjugate vaccine. Twenty-five days later, scattered red rash occurred on his face, both legs and hip, which had asymmetric distribution and not faded when pressed. His platelet count (PLT) was 18×109/L. Idiopathic thrombocytopenic purpura was diagnosed. He was given oral prednisone 5 mg thrice daily. The next day, the PLT was 3×109/L. He was treated with IV infusions of dexamethasone 5 mg, human immunoglobulin 5 g and vitamin C 1 g, then an intravenous injection of vitamin K1 5 mg. Three days later, the purpura basically subsided, the PLT was 290×109/L. Follow up of 1.5 years showed that his PLT had no abnormal changes.
  • 病例报告
    Chen Xia
    . 2011, 13(6): 393-1.
    A 65-years-old man with renal colic received a suppository of diclofenac 50 mg. Ten minutes later, the patient developed facial and generalized flushing, chest tightness, short of breath, tachycardia and dysphoria. Oxygen inhalation 3 L/min, an IV infusion of 10% glucose 500 ml, dexamethasone 10 mg via a Murphy’s dropper, and SC adrenaline hydrochloride 1.0 mg were given immediately, and then his symptoms subsided. Seventy minutes later, the patient developed dysphoria, short of breath, and tachycardia again. SC adrenaline hydrochloride 0.5 mg was readministered. Twenty minutes later, the patient gradually became quiet with normal respiration. Ten hours after receiving the diclofenac suppository, facial and generalized flushing disappeared.
  • 病例报告
    Chen Jinyue;Ru Aizhen
    . 2007, 9(3): 157-165.
    A 12-year-old girl with asthma was treated with montelukast sodium chewable tablets 5mg once daily and ketotifen 1mg twice daily. Two days later, she presented with enuresis once every night. On day 6, her enuresis was increased to three times at night. She stopped use of ketotifen, but enuresis still occurred. Later, montelukast sodium was discontinued. There was no occurrence of enuresis within a week. The enuresis recurred when she took the drug again. Then she stopped the drug again. At follow-up, 4 months later, there was no recurrence of the enuresis.
  • 论著
    Diao Yiping
    . 2007, 9(4): 243-246.
    Objective:To compare the acute toxicity and irritation of water extracts and alcohol extracts from raw kansui and vinegared kansui.Methods:Raw kansui and vinegared kansui were extracted with water and alcohol,respectively.The extracts were prepared to solutions at different concentrations in water.Then acute toxicity test(LD50)in mice and eye and skin irritation test in rabbits was performed with the solutions.The control was normal saline.Results:The half lethal dose(LD50)and 95% confidence interval of alcohol extract of raw kansui were(24.64±6.57)mg/g and 18.07 to 31.21 mg/g,respectively.The half lethal dose(LD50)and 95% confidence interval of alcohol extract of vinegared kansui were(106.35±15.88)mg/g and 90.47 to 122.23 mg/g,respectively.The toxicity of alcohol extract of vinegared kansui was significantly diminished as compared with alcohol extract of raw kansui(P<0.01).The alcohol extract of raw kansui had severe irritation.The irritation of alcohol extract of vinegared kansui was markedly diminished.There was statistically significance in comparison between the two alcohol extract groups or between the both groups and the control group(all P<0.01).The water extract of raw kansui and vinegared kansui had no irritation.There was no statistically significance in comparison between the two groups and the control group.Conclusion:The water extract of raw kansui and vinegared kansui had no toxicity approximately.The toxicity and irritation of alcohol extract of vinegared kansui was markedly lower than that of raw kansui,it was comparatively safer.
  • 调查研究
    Zhou Ying;zheng Guifeng
    . 2000, 2(1): 20-23.
    Objective: To analyze the liver damage caused by Zhuangguguanjie Wan for providing information about rational use of the drug. Methods: Liver damage caused by Zhuangguguanjie Wan in our hospital in the last seven years was reviewed in order to analyze its incidence, time of occurrence, clinical characteristics and cost. Results: Most cases were before 1996 and symptoms appeared after 48 days of taking medicine on average. The patients' ALT were 451065 U/L, T-BIL were 21.3376mol/L. The average time they were in hospital was 39.44 days and the average cost was 5605.36 yuan. Conclusion: Drug administration authorities should strengthen the management of package inserts and drug advertisement and the patient should be regularly tested for liver function when using it.
  • 中毒救治
    DONG Gao-hong;ZHANG Yan-guo;HAN Yue-dong;HU Xin-hong;WEI Kai-jun
    . 2012, 14(3): 165-2.
    A 49-year-old male patient ingested a Chinese herb decoction daily for psoriasis, the decoction contained Sophora tonkinensis root 15 g ( recommended dose 3-6 g/d ) and 11 other herbs. On day 4, he presented with weakness of limbs, anorexia, dysphasia, and decreased memory. On day 11, the decoction was stopped. On day 15, the patient suddenly developed coma, incontinence of feces and urine, and rigidity in extremities. The toxic encephalopathy was considered to be induced by an overdose of Sophora tonkinensis root. An IV injection of high-dose glucocorticoid combined with human immunoglobulin and other symptomatic treatments were given, his neurological symptoms disappeared.
  • 综述
    Jiang Luxi;Chen Yu;Zhao Li
    . 2014, 16(2): 114-5.

    Medications in pregnancy can be divided into five categories (A, B, C, D, X). Bronchial asthma medications involve controller medication and relief medication. Inhaled corticosteroids are recommended as first-line controller medications for pregnant women with asthma. Low to medium dose of these drugs is generally safe and budesonide (category B) is considered to be the first choice. Short-acting β2 -agonists are recommended as first-line relief medications for pregnant women with asthma and albuterol (category C) is the first choice. Systemic corticosteroids during pregnancy could cause elevated incidence of hypertension in pregnancy and preeclampsia. Besides, systemic corticosteroids in first trimester of pregnancy could induce occurrence of fetal cleft lip and cleft palate. Leukotriene modifier, cromolyn, and nedocromil have generally been established as safe to mothers and infants, but none of them is the first choice. Low dose theophylline for mild persistent asthma during pregnancy can be chosen, but serum concentrations must be monitored, and theophylline is not the first choice either. The use of long-acting β2 -agonists during pregnancy alone has no marked effect on fetal growth and development while the safety to mothers remains to be further investigated. Poor asthma control can lead to hypoxia in pregnant women and it can cause much harm to the mothers and infants. It appears that the risk of consequences of poorly controlled asthma is higher than the adverse effects of asthma medications. In a word, asthma therapy in pregnancy should firstly weight the advantages and disadvantages. Choice of appropriate medication is critical for ensuring maternal and infant health.

  • 中毒救治
    . 2002, 4(3): 169-172.
  • 综述
    . 2003, 5(5): 292-296.
    本文介绍了个体遗传多态性以及遗传药理学在安全用药中的作用。加深对药理效应和药物代谢个体差异的遗传因素及个体化用药的了解,从而提高临床疗效,减少药物不良反应。
  • 药物评介
    . 2005, 7(4): 304-306.
    度洛西汀是一种新型选择性5-羟色胺(5-HT)和去甲肾上腺素双重再摄取抑制剂,用于治疗重症抑郁和糖尿病性周围神经病变。与传统的抗抑郁药物相比,本品起效迅速,不良反应相对较小。本文对应用度洛西汀的禁忌证和不良反应进行了归纳和介绍,为该药的临床安全应用提供参考。
  • ADR咨询
    . 1999, 1(1): 44-44.
  • 安全用药
    Cai Haodong
    . 2009, 11(4): 253-5.
    Telbivudine is an oral nucleoside analogue with specific activity against the hepatitis B virus. It is an effective and convenient medication for treatment of chronic hepatitis B. However, telbivudine-associated creatine kinase elevations and myopathy have been sometimes reported in recent years. Therefore, the authors has reviewed the related medical literature in order to provide the basis for the safe telbivudine use in clinical practice. In the GLOBE trial, creatine kinase elevations were more frequent among patients on telbivudine treatment. Grade 3 or 4 CK elevations occurred in 7.5%-12.9% of patients treated with telbivudine. The majority of grade 3 or 4 CK elevations were transient, reversible, asymptomatic, and spontaneously declined, rarely leading to discontinuation. Myopathy is an unusual adverse reaction to telbivudine. The incidence of telbivudineassociated myopathy is lower than that of zidovudine-induced myopathy. But isolated cases of rhabdomyolysis have been reported during postmarketing use of telbivudine. The clinical characteristics of telbivudineassociated myopathy are similar to those seen in zidovudine therapy and different from those observed in statin therapy. The exact mechanism of CK elevations and myopathy associated with telbivudine is unknown. The CK level should be monitored during telbivudine treatment. If telbivudineassociated myopathy is confirmed, the drug therapy should be discontinued, and coenzyme Q10 may be given.
  • 病例报告
    QIAN Chong-fu;LIANG Xiao-li;HE Lu-lu
    . 2012, 14(3): 174-2.

    A 21-month-old boy with upper respiratory tract infection was given nimesulide granules 50 mg in 2 divided doses at 15-hour intervals. Three hours after taking the first dose, he developed convulsion, pallor and yellowish urine. Fifteen minutes after taking the second dose, he redeveloped convulsion, progressive worsening pallor, strong tea-colored urine. Laboratory tests showed the following levels and values: C-reactive protein 79.0 mg/L, white blood cell count 35.6×109/L, neutrophil count 27.1×109/L, hemoglobin 33.0g/L, platelet count 471×109/L, thrombin time 17.2 seconds,prothrombin time 20.4 seconds, international normalized ratio 1.63 and activated partial thromboplastin time 27.5 seconds, fibrinogen 2.95 g/L. He underwent electrocardiogram monitoring and received oxygen inhalation therapy, an IV infusion of dexamethasone, methylprednisolone and human immunoglobulin, an IV infusion of sodium bicarbonate, and a transfusion of washed red blood cells. The child worsened and presented with coma, twitching limbs, his blood pressure was 131/103 mm Hg and his heart rate was 153 beats/ min. He was treated with plasma exchange, anti-infective therapy, immunosuppressive drugs, hydration, and nutritional support, and then his condition improved. On hospital day 8, repeat routine blood tests showed a white blood cell count of 7.0×109/L, a neutrophil count of 5.3×109/L, a hemoglobin level of 117 g/L, a platelet count of 311×109/L, and a reticulocyte count of 0.02.

  • 病例报告
    Zhang Haiying;Ren Xiaolei;Li Yuzhen
    . 2011, 13(3): 188-2.
    A 79-year-old woman with rheumatoid arthritis was administered loxoprofen 60 mg. Two hours later, she developed generalised weakness, polyhidrosis, and red urine. Her blood myohemoglobin was 938 μg/L and urinary myohemoglobin was 2102 μg/L. Meanwhile the patient developed hematuria and her leukocyte count increased. Increased myohemoglobin was considered to be induced by loxoprofen. Loxoprofen was discontinued and the patient received anti-infective and supportive treatments. On day 7 of drug discontinuation, the blood myohemoglobin was 24 μg/L and urinary myohemoglobin was 174 μg/L. But her infection of urinary system did not improve and therapy was continued.
  • 安全用药
    Zhao Wei;Zhang Jianglin;Huang Feng
    . 2011, 13(4): 228-4.

    Leflunomide is an isoxazole agent and has immunosuppressant effects. It is mainly used in treatment of rheumatoid arthritis. Common adverse reactions of leflunomide include gastrointestinal disturbances, elevated liver enzyme levels, hypertension, headache, and alopecia. Recent studies have showed that leflunomide can cause peripheral neuropathy. The time to symptom onset of peripheral neuropathy is about 6 months after leflunomide treatment start. Clinical presentations are bilateral numbness, tingling, burning sensation, and pain in the extremities, cold peripheral extremities, and weakness of the extremities. The mechanism of leflunomide-induced peripheral neuropathy might be related to a direct neurotoxicity of the drug. The risk factors for peripheral neuropathy development include advanced age, diabetes mellitus, and combination therapy. Once symptoms of peripheral neuropathy associated with leflunomide occur,the drug should be withdrawn within 30 days.

  • Peng Wei;Gao Jie;Miao Liyan
    Adverse Drug Reactions Journal. 2009, 11(6): 429-2.
    A 65yearold man with lung cancer received gefitinib 250 mg once daily due to poor tolerance to several chemotherapeutic drugs. Two days later, the patient presented with chest distress, short of breath, and wheezing was heard in both lungs. His oxygen saturation was 0.60. Laboratory tests revealed the following levels and values: PO2 63 mm Hg, PCO2 45 mm Hg, ALT 445 U/L, AST 383 U/L, LDH 2 277 U/L, HBDH 968 U/L. A pulmonary CT scan showed bilateral pulmonary interstitial fibrosis with infections. Gefitinib was withdrawn. He was treated with an IV push of methylprednisolone, ambroxol hydrochloride, and omeprazole. His symptoms did not resolve. The resuscitation was unsuccessful and he died from multiple organ failure.
  • 论著
    Zhou Ying①;Lu Min①;Tian Shuohan①;Liang Yan①;Zhang Huilin①; Cui Yimin*;Zhang Jun②;Zhang Liming②;Zhan Siyan③
    . 2007, 9(4): 235-238.
    Objective: To investigate the effects of gatifloxacin on blood glucose metabolism, and compared those with levofloxacin. Methods: In a retrospective cohort study, 300 hospitalized patients with infectious diseases while receiving gatifloxacin or levofloxacin in our hospital from September 2005 to August 2006 were assigned to two groups: gatifloxacin group (150 cases: diabetics 35 and nondiabetics 115) and levofloxacin group (150 cases: diabetics 38 and nondiabetics 112). The patients in the gatifloxacin group were administered with IV gatifloxacin 400 mg daily. The patients in the levofloxacin group were administered with IV levofloxacin 200~500 mg daily. The changes of blood glucose were analyzed in the two groups. Results: Dysglycemia in the gatifloxacin group was 6 cases (4.0%) and in the levofloxacin group was 1 case (0.7%). The differences between the two groups were statistically significant (P=0.044). In the galifloxacin group, of the diabetic patients, 2 (5.71%) were hyperglycemia, 1 (2.86%) was hypoglycemia, and 2 (5.71%) were both hypoglycemia and hyperglycemia; of the nondiabeticy patients, 1(0.87%) was hyperglycemia. In the levofloxacin group, of 38 diabetic patients, 1 (2.6%) was both hypoglycemia and hyperglycemia. Conclusion: The incidence of dysglycemia related to gatifloxacin is higher than that of levofloxacin. Blood glucose levels should be monitored carefully when gatifloxacin is used in patients, especially in diabetic patients.
  • 病例报告
    Xiao Wenkai;Luo Leiming
    . 2007, 9(3): 212-213.
    Two patients developed severe anaphylactic reactions during intravenous infusion of monosialotetrahexosyl gangliosi- de sodium. The first patient, a 91-year-old man with Parkinson disease, was treated with monosialotetrahexosyl ganglioside sodium 40 mg by intravenous infusion. After 10 minutes of infusion, he developed shiver, palpitation, and cold sweat. His BP was decreased from 155/70 mmHg on admission to 130/60 mmHg. The second patient, an 84-year-old man with chronic renal failure and cerebral ischemia was treated with monosialotetrahexosyl ganglioside sodium 60 mg. After five minutes of infusion, the patient developed chest distress, palpitation, dizziness, shiver, peripheral coldness, cold sweat, and apathy. His BP was decreased from 150/80 mmHg on admission to 90/60 mmHg. After anti-anaphylaxis treatment and symptomatic therapy, both patients recovered. Monosialotetrahexosyl ganglioside sodium was stopped. There was no recurrence of similar symptoms.
  • 病例报告
    ZHENG Xiao-yuan;ZHANG En-juan;ZHANG Zhe
    . 2013, 15(2): 109-3.
    A 25-year-old female patient with pulmonary and intestinal tuberculosis received a HRZE antitubercular regimen comprising isoniazid (H) 0.3 g once daily, rifampicin (R) 0.45 g once daily, pyrazinamide (Z) 3 g once every three days, ethambutol (E) 0.75 g once daily. Three days later, she developed hepatic dysfunction. Six days later, she developed acute hepatic failure with hepatic encephalopathy. Laboratory tests showed the following values: alanine aminotransferase (ALT) 519 U/L, aspartate transaminase (AST) 1854 U/L, albumin 29.6 g/L, total bilirubin (TBil) 89.9 μmol/L, direct bilirubin (DBil) 59.2 μmol/L, prothrombin time 113 s, international normalized ratio 918, D-dimer 0.8 mg/L. All antitubercular agents were stopped, polyene phosphatidyl choline, reduced glutathione, ademetionine 1,4-butanedisulfonate, alprostadil, Xiangdan injection (香丹注射液) were given. On day 9, she presented with coma, fructose sodium diphosphate and mannitol were added to her regimen. She received plasma exchange and transfusions of fresh frozen plasma and cryoprecipitate. On day 11, she revived and supportive therapy was continued. One month later, repeat testing showed the following results: ALT 25 U/L, AST 64 U/L, albumin 39.4 g/L, TBil 65.8 μmol/L, DBil 40.2 μmol/L.【
  • 病例报告
    Li Zhenghan;Wu Donghong;Xu Binhua;Liu Jie;Wang Liping
    . 2014, 16(4): 245-3.
    A 35-year-old female patient received oral thiamazole 10 mg twice daily, vitamin B4 20 mg thrice daily, and two tablets of batilol tablets (50 mg per tablet) thrice daily for hyperthyroidism. On week 2 of medication, because of decreasing level of white blood cells, thiamazole was reduced to 10 mg once daily and four tablets of berbamine hydrochloride tablets thrice daily were added to the regimen. On day 16 of medication, the patient experienced fever with a peak temperature of 37.8 ℃ and red rash and itching on the limbs followed by generalized arthralgia. On day 20, slight swelling and positive tenderness appeared on proximal interphalangeal joints of index fingers and middle fingers of both hands, and metacarpopha-langeal joints of right index finger and middle finger. Positive tenderness also appeared on her both wrist joints, both ankle joints, and bilateral knee joints. Laboratory tests revealed the following values: erythrocyte sedimentation rate 42 mm/1 h, C-reactive protein 32 mg/L, antinuclear antibodies(ANA) 1 ∶ 320, and anti-histone antibodies(AHA)(+). Thiamazole was stopped while the other drugs were continued as before. Subsequently, the symptoms of pain and swelling of her joints gradually improved. After half a year of drug withdrawal, the ANA and AHA became negative.
  • 论著
    Li Wenjing;Huang Nan;Zhu Rongfei
    . 2014, 16(4): 205-4.
    ObjectiveTo understand the clinical characteristics of psychiatric adverse effects (PAE) caused by montelukast sodium and provide reference for clinical rational drug use.MethodsThe children who received montelukast sodium treatment in the department of allergy in Tongji Hospital from 2010 to 2013 were followed up and their data were collected. The diagnosis, situation of drug combination, the clinical manifestations, time of onset, and severity of the PAE, and the time to symptoms disappearing after drug discontinuation were analyzed.ResultsThe data of 1 481 children who met inclusion criteria were collected. Of them, 1 015 children were male and 466 were female. Their ages ranged from 3 to 17 years. Of the 1 481 patients, 623 children′s ages were 3-6 years, 603 were 7-12 years, and 255 were 13-17 years. Among them, 780 cases were diagnosed as allergic asthma and 701 cases allergic rhinitis. A total of 17 children developed PAE after treatment with montelukast sodium and the incidence rate was 1.15%(17/1 481). The incidence rate of PAE in male sodium and female children was 1.28(13/1 015) and 0.86%(4/466), respectively. The incidence rate of PAE among 3-6 year-old children, 7-12 year-old children,and 13-17 year-old children were 1.61% (10/623), 0.83% (5/603), and 0.78%(2/255), respectively. The incidence rate of PAE in children with allergic asthma and allergic rhinitis were 1.15% (9/780) and 114% (8/701), respectively. There were no significant differences in the incidence rates of PAE among different gender, ages, and diseases (all P> 0.05). Among the 17 children who developed PAE, 9 children developed sleep disorders (7 nightmare and 2 insomnia), 5 children developed behavior disorders (4 aggressiveness, 1 hyperactivity), 2 children developed unspecified anxiety, and 1 developed nightmares combined with hyperactivity. The PAE were mild in 14 patients and moderate in 3 patients. There were 15 patients whose PAE occurred within 1 week after montelukast sodium treatment and 1 patient whose PAE occurred within 2 week and 3 months. All the 17 patients recovered within 1 week after montelukast sodium discontinuation.ConclusionsThe PAE occurred in children after montelukast sodium treatment is mainly sleep disorders, especially nightmare. Most of PAE are mild and the children recover soon after drug withdrawal.
  • 论著
    Zhang Ailing;Liu Yao;Yang Liping;Hu Xin
    . 2014, 16(6): 350-6.
    ObjectiveTo analyze the influential factors for recurrent adverse cardiovascular events within one year and 15 years after percutaneous coronary intervention (PCI) in patients with coronary atherosclerotic heart disease (CHD).MethodsThe patients with CHD, who underwent PCI or bypass operation of coronary artery meanwhile in Department of Cardiology, Beijing Hospital from January 1998 to March 2013,had complete medical records and received dual antiplatelet therapy with clopidogrel and aspirin for one year, were enrolled in the study. Patients′ specimens of blood were collected and cytochrome P450(CYP)2C19 genotype associated with metabolism of clopidogrel were detected. The patients were divided into the reference metabolizers group (*1/*1), intermediate metabolizers group (*1/*2 and *1/*3) and slow metabolizers group (*2/*2, *2/*3 and *3/*3) by the results of genotype detection. The situation of recurrent adverse cardiovascular events within one year and 15 years after the first PCI and the correlative factors were analyzed retrospectively.ResultsA total of 210 patients were enrolled in the study. They comprised of 148 males and 62 females with age 49184 (67±10) years. There were 163 and 47 patients undergoing PCI for the first and second times, respectively. There were 185 and 25 patients undergoing PCI only and bypass operation of coronary artery meanwhile, respectively. There were 158, 156, and 91 cases complicated with hypertension, hyperlipoidemia, and diabetes, respectively. The incidence of adverse cardiovascular events in the reference metabolizers group, the intermediate metabolizers group, and the slow metabolizers group within one year after PCI were 13.3%(13/98), 24.7% (23/93), and 31.6% (6/19), respectively. The incidence of adverse cardiovascular events in the slow metabolizers group and the intermediate metabolizers group were 2.37 and 1.86 times of those in the reference metabolizers group, respectively. Carrying CYP2C19*2 or *3 genotype was the independent risk factor (OR=1.781, 95%CI: 1.04213.046, P=0.035) and moderate drinking of white spirit was the independent protection factor (OR=0.054, 95%CI: 0.17511.016, P=0.045) in adverse cardiovascular events within one year after PCI. The incidence of adverse cardiovascular events in the reference metabolizers group, the intermediate metabolizers group, and the slow metabolizers group within 15 years after PCI were 32.7% (32/98), 33.3%(31/93), and 36.8% (7/19), respectively, the differences among the 3 groups were not statistically significant. Combination with diabetes (OR=3.243, 95%CI: 1.24515.165, P<0.05)and with familial history of CHD (OR=2.683, 95%CI: 1.23215.359, P=0.006)were the independent risk factors in adverse cardiovascular events within 15 years after PCI.ConclusionsCarrying CYP2C19*2 or *3 genotype is the risk factor in recurrent adverse cardiovascular events in patient with CHD within one year after PCI. Combination of diabetes and with familial history of CHD are the risk factors in recurrent adverse cardiovascular events within 15 years after PCI. It is suggested that the patients who prepare to perform PCI or have performed PCI recently should detect the CYP2C19 genotype and decide whether or not to receive the antiplatelet therapy with clopidogrel by the results of genotype detection.
  • Xing Xiaoxuan, Chu Yanqi, Bai Xiangrong, Yan Suying
    . 2016, 18(6): 417.
    ObjectiveTo evaluate the efficacy and safety of preventive treatments with proton pump inhibitors (PPI) and histamine 2 receptor antagonists (H2RA) for stress ulcer bleeding (SUB) in postoperative patients.MethodsThe Cochrane library, Medline, Embase, CBM, CNKI, VIP, Wan Fang Data etc. were searched from the inception to March 2016. Randomized controlled trials (RCT) and quasi-RCT (qRCT) of preventive treatments with PPI and H2RA for SUB were collected. Inclusion criteria was any of the following outcome measures: (1) incidence of SUB, (2) SUB-related morbidity, (3) gastric juice pH, (4) hospital days, (5) hospital days in ICU, (6) adverse reactions related to SUB treatments with PPI or H2RA. Quality of methodology was evaluated using bias risk assessment tool from Cochrane collaboration networks. Meta-analysis was performed using RevMan 5.3 software and the results were expressed as relative risk (RR) and its 95% confidence interval (CI). Rating quality of evidence for outcome measures was assessed using the Grading of Recommendations Assessment Development and Evaluation (GRADE).ResultsA total of 14 RCTs and 1 qRCT were entered into this study and 1 334 patients were involved. Of the 1 334 patients, 653 were in the experimental group (PPI group) and 681 were in the control group (H2RA group). The overall quality of the 15 studies was lower. Randomization and double-blinding methods were applied only in one study, no allocation concealment methods were used, and patients′s loss to follow-up or withdrawal from the trial was not reported in any of the 15 studies. The funnel plot of SUB and SUB-related morbidity showed no significant publication bias. Meta-analysis showed that the incidences of SUB were 5.1% (25/493) and 17.7% (92/521) in the PPI group and H2RA group, respectively; there was statistically significant difference between the 2 groups [RR=0.33, 95%CI: 0.22-0.49; P<0.01]. The SUB-related morbidity was 0.6% (2/328) and 2.2% (8/359) in the PPI group and H2RA group, respectively; there was no statistically significant difference between the 2 groups [RR=0.39, 95%CI: 0.12-1.30; P=0.12]. Adverse drug reactions (ADR) were reported in 2 studies. The ADR incidences were 3.2% (1/31) and 6.1% (2/33) in the PPI and H2RA groups, respectively in 1 of the 2 studies [RR=0.53, 95%CI: 0.05-5.58, P=0.60] and no ADR was reported in the other study.ConclusionsPPI was superior to H2RA in preventing SUB, but there was no statistically significant difference in the SUB-related morbidity in patients with PPI and H2RA treatments. The incidence of adverse reactions of PPI and H2RA was low and mild.
  • . 2017, 19(3): 239.
  • 病例报告
    Chen Hong;Li Yan
    . 2008, 10(3): 157-2.

    A 47yearold man with hepatitis B was given atorvastatin 20 mg once daily and clopidogrel 75 mg once daily after undergoing percutaneous transluminal coronary angioplasty and stent implantation. About 3 months later, the patient was admitted to our hospital with fatigue, anorexia, and dark urine. Laboratory tests showed the following values: ALT 2 549 U/L, AST 1 621.7 U/L, TBil 42.3 μmol/L, and HBV DNA 8.41×105 copies/ml. Atorvastatin was discontinued, and clopidogrel was continued. He received liverprotective treatment. Four weeks later, his symptoms improved gradually, and his ALT, AST, TBil, and HBV DNA levels were 73.9 U/L, 51.8 U/L, 22 μmol/L, and <500 copies/ml, respectively.

  • 调查研究
    Wang Yuhua;Huang Caihong
    . 2004, 6(1): 9-11.
    Objective: To observe the clinical manifestations and pathological chan ges of drug-induced renal impairment. Method: 25 cases with drug-induced renal i mpairment were analysed retrospectively, who were confirmed clinically and patho logically. Results: 25 cases included both acute (20) and chronic (5) renal fail ure. In former there were acute renal tubular necrosis (13) and acute interstiti al nephritis (7). And their outcomes were deaths (2), recovered (15) and chronic (3). In latter all 5 cases were chronic interstitial nephritis, resulting in 3 deaths. The renal impairment related to dosage and couse of treatment for follow ing drugs: gentamicin, contrast media, cisplatin, methotrexate, NSAIDs, longdanx ieganwan, while no such relations were found in ampicillin, cefazolin, ciproflox acin. Conclusion: Dosage and course of the above-mentioned drugs for treatment should be cautioned, together with consideration of patients' age and physical condition, such as dehydration, hypoproteinemia, diabetes, nephrosis, the elderl y and children in particular.
  • 病例报告
    . 2005, 7(2): 138-139.
  • 不良事件
    . 2005, 7(2): 94-94.
  • 调查研究
    Zhang Fengxian;Liang Anpeng;Song Meihong
    . 2000, 2(3): 156-159.
    Objective: To analyse the rifampicin-induced renal insufficiency for clinical reference.Methods: The data of 32 cases were collected and reviewed from the national journals of 1991-1998. Results: Rifampicin-induced renal insufficiency related to the drug taken in the past and the hypersensitive constitution, yet it was in no relation with the dosage and discontinuous duration of the drug. Conclusion: Rifarnpicim would be cautiously tried for patients in clinical practice. The patient with allergic history should not take it; he should stop the drug immediately when allergic signs appeared at the early stage of administration.
  • 论著
    Fang Zhenwei;Shi Jia;Tang Huilin;Lin Yang
    . 2014, 16(5): 274-7.
    Objective To evaluate the effects of dapagliflozin on cardiovascular safety in patients with type 2 diabetes mellitus.MethodsPubMed (up to November 2013) and Cochrane Library, Embase, CNKI, and Wanfang Database (up to October 2013) were searched using "dapagliflozin", "sodium-glucose cotransporter 2 inhibitor*", "SGLT2 inhibitor*", and "BMS 512148" as keywords. Randomized controlled trials (RCT) concerning the effects on cardiovascular safety of dapagliflozin in patients with type 2 diabetes mellitus were filterted. The intervening measures included dapagliflozin in comparison with placebo or other hypoglycemic agent and combination therapy of dapagliflozin and other hypoglycemic agent in comparison with concomitant use of the same hypoglycemic agent and placebo or another hypoglycemic agent. The primary endpoint was major adverse cardiovascular event (MACE) and the secondary endpoints included myocardial infarction, stroke, all-cause mortality, and cardiovascular mortality. Meta-analysis was conducted using RevMan 5.2 software. The dichotomous outcomes were tested by Mantel-Haenszel and odds ratios (OR) and 95% confidence interval (CI) were calculated.ResultsA total of 11 RCT papers were enrolled in this Meta-analysis. There was no statistically significant difference in the incidence of MACE between the dapagliflozin group (0.39%, 5/1 271) and the placebo group (0.54%, 3/551) (OR=0.65, 95%CI:-0.16-2.65, P=0.55), and also between the dapagliflozin group (0.24%, 1/422) and the metformin group (0.24%, 1/409) (OR=0.97, 95%CI:-0.14-6.88, P=0.98). There was no statistically significant difference in the incidence of stroke between the dapagliflozin group (0.28%, 3/1 060) and the placebo group ( 0.29%, 1/343) (OR=0.76, 95%CI:-0.11-5.14, P=0.77). There was no statistically significant difference in the incidence of all-cause fatalities between the dapagliflozin group (0.26%, 6/2 278) and the placebo group (0.18%, 2/1 082) (OR=0.91, 95%CI:-0.30-2.75, P=0.86), and also between the dapagliflozin group (0.24%, 1/422) and the metformin group (0.24%, 1/409) (OR=0.97, 95%CI:-0.14-6.88, P=0.98). There was no statistically significant difference in the cardiovascular fatalities between the dapagliflozin group (0.24%, 3/1 271) and the placebo group (0.18%, 1/551) (OR=0.81, 95%CI:-0.16-4.27, P=0.81), and also between the dapagliflozin group (0.24%, 1/422) and the metformin group (0.24%, 1/409) (OR=0.97, 95%CI:-0.14-6.88, P=0.98).ConclusionDapagliflozin did not increase the risk of MACE in patients with type 2 diabetes mellitus.
  • Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, Chinese Pharmacological Society Professional Committee of Drug-induced Diseases, Chinese Pharmaceuti
    Adverse Drug Reactions Journal. 2019, 21(2): 92-97. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.003
    Drug labels are texts with legal effects in guidance of doctors′ prescribing and patients′  rational drug use. Medication errors related to drug labels referred to medication errors caused by defects in drug labels (with uncertain, inaccurate or inconsistent information), or by incorrect understanding or improper execution of drug labels by physicians, pharmacists, nurses, or patients. Medical, pharmacy and legal experts, who were organized by Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, Chinese Pharmacological Society Professional Committee of Drug-induced Diseases, Chinese Pharmaceutical Association Professional Committee of Hospital Pharmacy, and Adverse Drug Reactions Journal Agency, formulated the guideline for prevention of medication errors related to drug labels, based on the Expert Consensus on the Management of Drug Errors in China. The medication errors related to the drug labels included drug selection errors, drug management errors in the pharmacy and clinical medication errors. The risk factors of medication errors related to drug labels included systematic factor, such as self-defects in drug labels, human factors, such as misunderstanding or improper execution on drug labels by clinicians, pharmacists, nurses, and patients. The prevention strategies for medication errors related to the drug labels included technical strategy, such as enforcement and constraint policy, automation and informatization of information collection and detection of drug labels; management strategies, such as corresponding regulatory framework, education and information services. The guiding principles applied to the medical staff participating in maintenance of drug label information and drug selection, management, and use, and the patients who use drugs according to the labels.
  • Xie Aqing, Wang Lin
    Adverse Drug Reactions Journal. 2020, 22(4): 257-261. https://doi.org/10.3760/cma.j.cn114015-20190516-00422
    The overexpression of programmed cell death 1 receptor (PD-1) on the surface of T cells and programmed cell death 1 ligand 1 (PD-L1) secreted by tumor cells in tumor tissue inhibits the cellular immune response to a certain degree, so that the growth of tumor cells can escape the surveillance and clearance of the immune system. PD-1/PD-L1 inhibitors are specific protein antibodies designed for the expression of PD-1 or PD-L1, which can prevent the interaction between PD-1 and PD-L1 on tumor cells, thus partially restore T cell function and enhance tumor cell killing by T cells. However, because of the increasingly prominent drug resistance of PD-1/PD-L1 inhibitors in clinical applications, their efficacy cannot be sustained or even there were non-response to drugs in some patients. Recent studies have found that the expression of PD-1 and PD-L1 is regulated by many immune factors, and the transport and degra-  dation processes of PD-L1 are also affected by many factors, such as glycosylation, phosphorylation, ubiquitination, and so on. The researches on the regulatory factors that may interfere in the PD-1/PD-L1 pathway will help to develop new treatment strategies to overcome drug resistance of PD-1/PD-L1 inhibitors in tumor, thereby improving the efficacy of tumor immunotherapy.
  • Li Huanfen, Hu Yueqin
    . 2016, 18(2): 149.
    A 45-year-old woman with sepsis, pulmonary infection and cholecystitis received IV infusion of moxifloxacin for injection 0.4 g (250 ml) once daily. About 30 minutes after the first IV infusion, the patient developed the symptoms of dizziness and blurred vision. Two hours later after the end of IV infusion, the above-mentioned symptoms disappeared spontaneously. The same symptoms recurred about 30 minutes after IV infusion on the next day. Moxifloxacin was stopped and changed to IV infusion of piperacillin and tazobactam 4.5 g added to 0.9% sodium chloride for injection 100 ml once per 8 hours. Subsequently the patient did not have the symptoms of dizziness and blurred vision.
  • Wan Liyan, Yuan Liping, Wei Jianying, Wu Yang, Ning Ming, Xu Dan, Dong Moran
    . 2016, 18(3): 170.
    ObjectiveTo investigate the potentially inappropriate medications (PIM) and their risk factors in elderly inpatients.MethodsThe medical record data of patients≥65 years, who were discharged from the Department of Geriatrics in Tsinghua University First Hospital between October 2013 and May 2014, were collected and retrospectively studied. The PIM and PIM related to certain diseases were evaluated according to the 2012 Beers criteria. Multivariate logistic regression were performed to analyze the risk factors of PIM.ResultsA total of 217 patients were enrolled in this study. Of them, 120 (55.3%) were males and 97 (44.7%) were females with age from 65 to 97 years and their average age was (80±6) years. In the 217 patients, the disease categories were 3 to 14 in each patient, 3-5 in 52 patients (24.0%), 6-10 in 141 patients (65.0%), 11-14 in 24 patients (11.1%), and the average category was 7±3. The hospitalization time was 4-57 days with average time of (17±10) days in each patient. In the 217 patients, the categories of drugs were 2-49 each day in each patient, 2-5 kinds in 33 patients (15.2%),6-10 in 84 patients (38.7%), >10 kinds in 100 patients (46.1%), and the average category was 12±8. In the 217 patients, 79 patients (36.4%) received PIM listed in the 2012 Beers criteria, 16 kinds of drugs were involved and cumulative 76 PIMs were found. Of them, the most wildly used drugs were sedatives and hypnotics [51.3% (39/76)]. In the 79 patients with PIM, 42 patients were given PIMs related to certain diseases in the 2012 Beers criteria, 18 kinds of drugs were involved and cumulative 62 PIM involving disease status such as fracture, dementia, insomnia, constipation, heart failure, prostatic hyperplasia, delirium, chronic kidney disease, and Parkinson′s disease. Logistic regression analysis showed that the risk factors of PIM were hospitalization time (OR=1.06, 95%CI: 1.022-1.094, P=0.001), disease categories (OR=1.15, 95%CI: 1.014-1.302, P=0.03), and daily used drug categories (OR=1.05, 95%CI: 1.005-1.104, P= 0.03).ConclusionThe incidence of PIMs in elderly inpatients was high and its risk factors are hospitalization time, disease categories and daily used drug categories.
  • 中毒救治
    Xie Lijing;Wang Yingwei; Long Xin;Sun Chengye
    . 2011, 13(4): 240-3.

    A 44-year-old man took the tuber of Alocasia macrorrhiza by mistake. Several minutes after ingestion of the tuber, he presented with numbness of lip, sore throat, nausea, vomiting, salivation, dyspnea, and dysphonia. Twenty minutes after poisoning, he was hospitalized and diagnosed as having acute laryngeal edema. He received diphenhydramine 20 mg and dexamethasone 5 mg via IV push, followed by an IV infusion of dexamethasone 10 mg. Meanwhile oxygen inhalation, liver protective treatment, and other symptomatic treatment were given. Five hours after poisoning, his symptoms gradually resolved and, 50 days later, he recovered. Alocasia macrorrhiza is a poisonous plant of Alocasia Schott in the family Araceae, and it contains sapotoxin and calcium oxalate which can induce neurological and gastrointestinal disorder after ingestion of the plant. The latent period from exposure to onset of symptoms is 10 to 30 minutes and death might occur in patients with severe poisoning. Skin contact or eye contact with Alocasia macrorrhiza juice can cause pruritus, conjunctivitis, and even blindness. Inhalation of Alocasia macrorrhiza powder can lead to severe mucosal irritation in the eye, nasal cavity, and throat. Poisoning could be diagnosed by the history of contact with the plant and clinical manifestations. There is no specific antidote for Alocasia macrorrhiza poisoning and main management is symptomatic treatment.

  • 论著
    Wu You;Jia Jianping
    . 2006, 8(6): 417-422.
    Objective:To observe the effect of Dengzhanshengmai capsules on cerebral ischemia and reperfusion injury in rats,and discuss its mechanism. Methods:Eighty rats were divided into 5 groups:sham-operated group 1,sham-operated group 2,saline control group,low-dose Dengzhanshengmai group,and high-dose Dengzhanshengmai group. Each group had 16 rats. The middle cerebral artery occlusion model in rats were made by the modified suture-occluded method of Zea longa. The rats were administrastion with Dengzhanshengmai capsules orally before and after cerebral ischemia. Neurological score was carried out. Some haematological indexes (such as prothrombin time,fibrin content,and maximum agglutination rate of platelets),plasma endothelin level,and serum nitrogen oxide level were measured. The size of crebral infarct and edema,the activity of SOD,and the content of MDA were measured as well. Results:The neurological score in the low-dose and high-dose Dengzhanshengmai groups after 2 and 24 hours reperfusion was lower than those of the control group(1.75±0.68?1.71±0.77 vs2.35±0.86,1.88±0.81、 1.71±0.69 vs2.65±1.17,P<0.05). The PT in the high-dose Dengzhanshengmai group was longer than that of the saline control group (18.0±0.8s vs17.0±0.6s,P<0.05) while the level of ET was lower(13.9±4.9 pg/ml vs26.3±13.2,P<0.05). The infarct size and edema size in the Dengzhanshengmai group were smaller than those of the saline control group(10.3±3.8%? 9.7±5.7% vs11.9±3.0%,7.7±3.0%、 6.9±3.9% vs 18.3±7.0%,P<0.05),The activity of SOD in the Dengzhanshengmai group was higher than that of the saline control group (291±78 U/mg、 301±92U/mg vs213±40 U/mg,P<0.05)while the content of MDA was much lower(1.41±0.47nmol/mg、 1.36±0.61nmol/mg vs 2.09±0.32 nmol/mg,P<0.05,P<0.01). But no significant differences were found in the levels of Fg,maximum aggregation of platelets,and nitrogen oxide. Conclusion:Dengzhanshengmai capsules is effective for preventing and treating cerebral ischemia and reperfusion injury.The mechanisms of its effect may be associated with improving the activities of antioxidases,suppressing lipidperoxidation,alleviatingthe injuries induced by free radicals,suppressing blood agglomeration,and reducing blood vessel resistance.
  • 调查研究
    Huang Jiwei;Peng Haiying
    . 2006, 8(6): 423-425.
    Objective:To discuss the clinical features,predisposing factors,and prevention of SSRI discontinuation syndrome. Methods:The clinical features,the predisposing causes,and management in 42 patients with SSRI discontinuation syndrome were investigated retrospectively. Results:The main symptoms of SSRI discontinuation syndrome were dizziness,nausea,vomiting,headache,abnormal sensation,depressed mood,insomnia,anxiety,and agitation. The symptoms began within 1 to 5 days after discontinuation of SSRI and persisted 1 to 7 days. Of the 42 patients,27 had taking paroxetine,6 sertraline,6 citalopram,and 3 fluoxetine. The predisposing factors of SSRI discontinuation syndrome were sudden withdrawal by oneself (30 cases),missed doses (6 cases),dose reduction (4 cases),and drug switching (2 cases). Conclusion:There should be care of discontinuation syndrome after abrupt cessation of SSRI in clinical practice. The SSRI implicated most often is paroxetine. The gradual tapering or use of an agent with longer half-life is necessary in order to avoid the development of SSRIdiscontinuation syndrome.
  • 病例报告
    Lin Wanzhen;Yuan Gang;Chen Xiao
    . 2009, 11(4): 283-2.
    A 63 yearold man with diabetes mellitus and hypertension received longterm treatment with hypoglycemic and antihypertensive agents. The patient was administered with calcium dobesitate 0.5g once daily for retinal hemorrhage. Eight days later, the man developed a fever (38.8℃) and asthenia. After discontinuation of calcium dobesilate and symptomatic treatment, he recovered. Subsequently, his fever recurred after readministration of calcium dobesilate. There were four relapses in total. Other medications were not stopped during calcium dobesilate use.
  • 病例报告
    Liu Walia;Wang Lixiab;Wang Junhuia
    . 2008, 10(3): 211-2.

    A 21yearold woman received intravenous infusion of clindamycin 0.6 g in 500 ml of glucose 5% once daily for treating hyperpyrexia. Three days later, IV clindamycin was changed to oral clindamycin 0.3 g. After taking the second oral clindamycin, she presented with skin rash over her entired body. The laboratory test revealed the following values: ALT 267 U/L, AST 176 U/L, γ-GT 202 U/L. Clindamycininduced adverse reactions were suspected. Clindamycin was discontinued, and she was treated with IV dexamethasone, vitamin C, glucurolactone, and bifendate. Twenty days later, her skin rash disappeared completely and her liver function parameters decreased, and then the patient was discharged. On reexamination, her liver function returned to normal range 3 weeks after discharge.

  • 中毒救治
    . 2005, 7(1): 37-40.
    常见的致痉挛性灭鼠剂有八个品种,其中五种为禁用品种。该类灭鼠剂对所有哺乳动物毒性都很大,对中枢神经系统均有直接兴奋作用,主要表现为癫痫样发作,常伴有程度不同的意识障碍。中毒主要原因是误食含灭鼠剂的毒饵或被灭鼠剂污染的食物。多数致痉挛性灭鼠剂无特效解毒剂,仅乙酰胺为氟乙酰胺、氟乙酸钠及甘氟中毒的特效解毒剂。
  • 中毒救治
    . 2005, 7(5): 351-353.
    复方苯乙哌啶片为具有收敛及减少肠道蠕动的常用止泻药。该药常引起中毒,尤其是低剂量即可引起儿童中毒,现已被国外列为儿科重大危害药物之一,不宜作为治疗儿童腹泻病的常规用药。本文就该药的药代动力学、中毒的临床表现、诊断及治疗作一介绍,以对其中毒问题引起重视,加强对该药的管理和使用。
  • 论著
    XIE Li-jing;WANG Xiao-jun;HOU Xiao-ping;LIU Quan-ru;WANG Ying-wei;LONG Xin;MA Pei-bin;SUN Cheng-ye
    . 2013, 15(1): 17-5.

    ObjectiveTo validate the effects of the etiological judgment model for poisoning event in a poisoning event caused by Aconitum in Tacheng District, Xinjiang Uygur Autonomous Region. Methods The main point of the etiological judgment model for poisoning event was synthesized determination according to the results of the scene, cases and laboratory research. After receiving the report of poisoning event, the specialists in local Center for Disease Control and Prevention (CDC) hastened to the scene to conduct epidemiological investigation, to obtain the clinical features of the poisoning patients, and to collect the specimen of blood and vomitus of patients and the fresh sample of suspicious poisonous plants. Chinese Center for Disease Control and Prevention organized the relevant institutes to conduct morphological and DNA molecular identification of the poisonous plant, toxin detection of the blood and vomitus specimen. The above-mentioned results were synthesized to determine the poisoning reason and provide guidance for clinical diagnosis and treatment.ResultsOn May 30, 2010, 13 staffs in a metal company in Tacheng District picked and ate the “wild celery” which grew in nearby mountain. Within 15 to 30 minutes after eating the “wild celery”, they successively developed numbness in mouth, lips, and limbs, as well as asthenia, nausea and vomiting. They were sent to a local hospital, 4 patients died on the way to the hospital,other 9 patients received rescue therapy in the hospital, 2 of them died about 4 hours after poisoning despite resuscitation attemempts. The morphological identification of fresh sample of suspected poisonous plants was demonstrated as Aconitum, Raunnculaceae. Aconitine was detected in a vomitus specimen and 3 blood specimens. The aconitine content in blood specimens were 0.17, 0.25 and 0.48 μg/L, respectively. The result of DNA molecular identification showed that the fresh leaves of suspected poisonous plants collected from the scene belonged to the same species of Acontium. This event was determined as a sudden poisoning event caused by picking and eating Acontium stems and leaves by mistaken.ConclusionThe etiological judgment model for poisoning event might play an important guiding role in the determination of the cause of poisoning events.

  • 病例报告
    Huang Lifang
    . 2007, 9(5): 371-372.
    A 45-year-old man with primary hypertension took nifedipine tablets 5 mg thrice daily for 6 years.And no adverse reac- tions were found.Later,he received nifedipine sustained-release tablets 10 mg twice daily.One year later,he developed gingival hy- perplasia with bleeding and pain.After the treatment with roxithromycin,metronidazole and fenbufen capsules,his conditions did not improve.Drug-induced gingival hyperplasia was suspected,the nifedipine sustained-release tablets Was discontinued and replaced with benazepril and metoprolil.One month later,his gingival hypcwlasia disappeared.Afterwards,the patient took nifedipine sustained-re- lease tablets 5 mg twice daily again because of poor control of his hypertension.Two months later,his gingival hyperplasia recurred. One month after stopping the drug,the symptom resolved again.
  • 病例报告
    Liu Bibo
    . 2007, 9(5): 376-376.
    A girl,aged 2 years and 8 months,received IM analgin(dosage not stated)for upper respiratory infection.Approximately 6 hours later,she developed scarlatiniform erythema.Despite treatment with dexamethasone and chlorphenamine,her symptoms did not resolve.An examination showed mild swelling of left submaxilary and retroauricular lymph node,generalized erythema with pustules.Her WBC was 17×109/L and her N was 0.856.After treatment with dexamethasone,calcium gluconate,chlorpheniramine,and azithromycin for 3 days,her erythemas resolved and pustules obviously diminished.Six days later,she recovered.Tracing her previous history,the girl had developed scarlatiniform erythema following taking analgin 4 months before.
  • 病例报告
    Su Dan
    . 2007, 9(5): 359-359.
    A 41-year-old woman with bronchial asthma was administered with clindamycin phosphate 1.5 g by intravenous infusion.She had a intolerable bitter taste.Examination showed many white herpes with different size on both sides of the body of tongue.Approximately 30 minutes after the accomplishment of infusion,his allotriogeusia resolved gradually.And herpes on the tongue disappeared one day later.After replacement with penicilin for anti-infection treatment,the symptom did not recur.
  • Liang Huayu, Wang Yuqin
    . 2016, 18(4): 286.
    Benzbromarone is a potent uricosuric drug by inhibiting the re-absorption of uric acid salt in renal proximal convoluted tubules and widely used for gout and hyperuricemia. The common adverse reactions of  benzbromarone are gastrointestinal symptoms (including diarrhea, stomach discomfort, and nausea),  skin  allergies (including rash and itching), and  abnormal liver function with the increase of  aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase. Hepatotoxicity induced by benzbro-marone is mainly associated with the  suppression of β-oxidation and respiratory chain, reducing the synthesis of ATP, increasing the generation of reactive oxygen species, promoting the opening of mitochondrial permeability transition pore and leading to apoptosis induced by the release of cytochrome C. In addition, the synthesis of  adjacent benzene ortho-quinone intermediate and the decrease of glutathione, level could exacerbate hepatotoxicity. Cytochrome P450(CYP) oxidase is important for metabolism of benzbromarone and increase of the activity of CYP2C9/CYP3A4 and  CYP2C9*3 mutation are likely to increase the hepa-totoxicity of benzbromarone.
  • 综述
    He Bishan;Lin Zichao;Huang Hongbing;Liu Tao;Wang Fenghua
    . 2014, 16(4): 232-5.
    Chemotherapeutic regimens based on fluoropyrimidines such as 5-fluorouracil, capecitabine, and tegafur, gimeracil and oteracil potassium (S1) are widely used in a variety of solid tumor therapy. Cancer patients are high-risk persons of thrombosis and anticoagulant therapy is recommended for patients with thrombosis or with risk factors of thrombosis. At present, warfarin is the widely used oral anticoagulant. There are drug interactions when 5-fluorouracil, capecitabine, and S1 are given in combination with warfarin and it may lead to elevated international normalized ratio and symptoms of bleeding. Most patients could recover after warfarin withdrawal, dosage reducing, and replacement with low-molecular heparin. However, a few patients may require blood transfusion. The mechanism of drug interactions due to concomitant use of fluoropyrimidines and warfarin remains unclear and may be related to inhibiting activity of metabolic enzyme of warfarin—hepatic cytochrome P450 2C9 by 5-fluorouracil or its metabolites.
  • . 2015, 17(3): 164.
  • Zhang Wensi, Zhang Yanhua, Li Xuemei, Han Jingxia, Ding Yi
    Adverse Drug Reactions Journal. 2020, 22(11): 613-618. https://doi.org/10.3760/cma.j.cn114015-20200302-00195
    Objective To explore the occurrence of medication errors (MEs) involving cytotoxic drugs in pharmacy intravenous admixture service (PIVAS). Methods All the prescriptions containing cytotoxic drugs from January 2016 to December 2019 in PIVAS in Peking University Cancer Hospital were collected using the hospital information system. ME records found by pharmacists during the prescription review were screened out (defined as prescription error) and "the medication error record book" was searched to screen out MEs in PIVAS (defined as admixture errors) in the same period. Descriptive analysis was conducted on the grade, classification, links in which the MEs occurred, people who triggered, ME content, and the involved cytotoxic drugs of these MEs. In addition, the MEs that were not found in PIVAS but passed to the next link were defined as out-door errors. Results A total of 347-367 prescriptions involving cytotoxic drugs were received in PIVAS in our hospital during the study period, in which 1-080 MEs were found, and the incidence of ME was 0.31%. The 1-080 MEs were all grade B errors that did not cause patient harm, of which 841 (77.87%) were prescription errors and 239 (22.13%) were admixture errors. Five MEs were not intercepted and led to out-door errors and the incidence of out-door errors was 0.01‰(5/347-367). The top 5 ME contents were wrong solvent (63.15%, 682/1-080), incomplete prescription (11.67%, 126/1 080), wrong number (8.80%, 95/1-080), wrong dose (6.11%, 66/1-080), and wrong method in intravenous administration (4.35%, 47/1-080). A total of 32 cytotoxic drugs were involved in 1-080 MEs and the top 5 were paclitaxels (23.24%, 251/1-080), fluorouracil (12.59%, 136/1-080), doxorubicin (6.39%, 69/1 080), cisplatin (5.46%, 59/1-080), and etoposide (5.37%, 58/1-080). Conclusions The incidence of ME was 0.31% in PIVAS in our hospital, all of which were grade B errors. The errors mainly were prescription errors, the main contents were wrong solvent, and the main drugs involved were paclitaxels, fluorouracil, doxorubicin, cisplatin, and etoposide.
  • 综合报道
    . 2002, 4(5): 315-317.
    近年来,关于药物引起无菌性脑膜炎的报道有增多趋势。报道最多的药物类别有非甾体抗炎药物、抗微生物药物、静注丙种球蛋白、单克隆抗体;报道较少的有鞘内注射造影剂、抗癫痫药物、疫苗、抗肿瘤药物等。药源性无菌性脑膜炎以发热、头痛、脑膜刺激征、恶心和(或)呕吐、关节肌肉疼痛、脑脊液中性粒细胞增多和蛋白质浓度升高、脑脊液培养无细菌生长、病程短、停药后恢复快为特征。
  • Wang Bing, Zhou Guangjie, Li Jinfeng, Tang Huaying, Zhang Ailun, Huang Huixuan
    Adverse Drug Reactions Journal. 2022, 24(4): 220-222. https://doi.org/10.3760/cma.j.cn114015-20210914-00995
    A 66-year-old male patient with anxiety and depression received lorazepam 1-mg twice daily and buspirone 10-mg twice daily. Two months later, the patient developed chills, fever, drowsiness, and stiffness of limbs, etc. Laboratory tests showed white blood cell count 13.5×109/L, neutrophils 0.89,C-reactive protein 68.7-mg/L, serum creatinine 211-mmol/L, direct bilirubin 10.3-mmol/L, alanine amino- transferase 96-U/L, aspartate aminotransferase 121-U/L, creatine kinase (CK) 4-557-U/L, CK-MB 83-U/L, lactate dehydrogenase 462-U/L, α-hydroxybutyrate dehydrogenase 339-U/L, and troponin 116-ng/L. Malignant syndrome caused by buspirone was considered. The drug was stopped, lorazepam was continued, and oxygen inhalation, ECG monitoring, physical cooling, anti-infection, and other treatments were given. The patient still had fever and developed deep coma, with brown urine and myoglobin >3 000-mg/L. Secondary rhabdomyolysis was considered. Anti-infection treatment was continued and treatments such as correcting electrolyte balance, alkalizing urine, and diuresis were given. On the 10th day of drug withdrawal, the patient had normal limb activity and urine color, his creatine kinase was 246-U/L, and myoglobin was 856-mg/L. One month later, the laboratory tests showed no obvious abnormalities and no malignant syndrome releted symptoms recurred. The rhabdomyolysis secondary to malignant syndrome in the patient was considered to be possibly related to buspiron and the combination with lorazepam might promote its occurrence.
  • 论著
    Li Lianzhen①;Gao Webin①;Xu Bo②;Yin Liangwei③
    . 2006, 8(3): 177-180.
    Objective: To observe the effect and safety of weekly low-dose gemcitabine therapy for treatinng on-small-cell lung cancer.Methods:Eighty-four patient with non-small-cell lung cancer were randomly and evenly assigned into two groups:routine groupand trial groups.Routine therapy(routinegroup)was as follows:Gemcitabine 1200mg/m2,by intravenous infusio,non day 1,8,15. Weekly low-dose therapy(trialgroup) was as follows: Gemcitabine 600mg/m2,by intravenous infusion,on day 1,8,15 ,22. Twenty-eight days constitutead sigle course of treatment for each group,and the patients of each group should receive2 courses of treatment in succession at least. The therapeutic effect and safety were evaluated in the end of the second course of treatment. Results:Chemotherapy effectiv reate was 23.81% in routine group,28.57% in trial group(p>0.05).Most adverse reactions were mild. The adverse reaction such as leucocyte or hemoglobin decrease,nausea and vomiting,inappetenc,eliverimpairmentwere significant differenbtetween the2 groups(p<0.05) ,while there were no significant difference in platelet decrease,kidney impairment,cutaneous reaction,dropsy and so on between the 2 groups(p>0.05). Conclusion: Weekly low-dose gemcitabine therapy is safe and effective in treatment of non-small-cell lung cancer.
  • 调查研究
    Yin Jian;Wu Xhiqiang;Hou Peng
    . 2005, 7(1): 17-20.
    Objective: To investigate the clinical characteristics and treatment of the upper gastrointestinal (GI)bleeding induced by low-dose aspirin (ASP). Methods: The data of patients with bleeding from non-esophageal varices were retrospectively analysed and divided into ASP group(38 cases) and non-ASP group(342)according to ASP administration before bleeding. Results: Average age of ASP group(64.5±5.4)is older than non-ASP group (43.5±16.5). The occurrences of gastric ulcer and mucosal lesion were higher in ASP group(69.1%)than in non-ASP group(26.70%)(P<0.01).No difference was found in bleeding amount and Hb .Hemostatic time was longer in ASP group(average 3.7 days)than in non-ASP group(average 2.3days)(P<0.05). Conclusion: Low-dose ASP is attributed to upper GI bleeding in old patients-with high occurrence of gastic disorders and longer hemostatic time.
  • 病例报告
    Lyu Xiaofei;Nian Min;Li Haiqin;Qiu Su
    . 2014, 16(3): 175-2.
    A 21-year-old female with acute gastroenteritis received an intravenous infusion of levofloxacin 0.4 g, once daily. She developed palpitation, sense of suppression in the chest and dizzy suddenly during the intravenous infusion on day 3. Electrocardiographic examination showed the following results: heart rate 39 times/min, third degree atrioventricular block, junctional escape beat and ventricular escape. Levofloxacin was withdrawn immediately. Twenty-six minutes later, third degree atrioventricular block converted to first-degree atrioventricular block and the heart rate was 58-66 times/min spontaneously.
  • 调查研究
    Ma Xiuyun;Cai Haodong;Zheng Hong;Duan Ying
    . 1999, 1(3): 154-159.
    Objective: To observe prospectively the adverse reactions of a new drug, lamivudine, for hepatitis B. Methods: The adverse reactions were observed and both hematology and biochemical analyses were made in two groups, with lamivudine 100 mg a day and the other with starch tablet by random double blind placebo control clinical method for twelve weeks, and then the treatment followed for forty to one hundred and fifty-six weeks with lamivudine 100 mg a day. Results: During the double blind treatment period, no significant differences were shown in their incidence of the adverse reactions and hematology and biochemical indices. Some light adverse reactions were produced in patients, but with good tolerance in the open treatment period. The most patients' liver function was improved. However, more studies must be done on whether it is associated with a hyperlipidaemia or cardiovascular complications. Conclusion: Lamivudine is safe for hepatitis B. It has few adverse reactions and can be use...更多d for a long time with care of the blood lipid profile.
  • . 2013, 15(6): 301-1.
  • 病例报告
    HUANG Yu-ling;YANG Hui;XU Cang-hai
    . 2012, 14(2): 109-3.
    A 68-year-old woman with paronychia received an IV infusion of ceftriaxone sodium 4.0 g in 0.9% sodium chloride 250 ml once daily. She developed low back pain during drug therapy. On day 3, she was hospitalized with transient syncope and hematuria. On admission, she presented with severely jaundiced skin and sclera. Laboratory tests revealed the following results:white blood cell count 39.4×109/L, neutrophil 0.97, red blood cell (RBC) count 1.9×1012/L, hemoglobin (Hb) 42 g/L, reticulocytes 0.03, blood urea nitrogen 15.0 mmol/l, serum creatinine (SCr) 336 μmol/L, alanine aminotransferase (ALT) 380 U/L, aspartate aminotransferase (AST) 930 U/L, gamma-glutamyltransferase (γ-GT) 60 U/L, total bilirubin (TBil) 235.1 μmol/L, direct bilirubin (DBil) 130.6 μmol/L, and indirect bilirubin (IBil) 104.5 μmol/L, lactate dehydrogenase 2198 U/L, creatine kinase 211 U/L, α-hydroxybutyric dehydrogenase 1538 U/L, creatine kinase-MB 22 U/L, prothrombin time 21.3 seconds, activated partial thromboplastin time 50.5 seconds, thrombin time 29.6 seconds, fibrinogen 1.03 g/L, D-dimer 10.4 mg/L, and Coomb’s C3(+). Routine urine tests showed the following results: urine bilirubin(++), occult blood (+++),protein(++)and 3 RBC/high power field. Ceftriaxone sodium-induced acute hemolytic anemia with multiorgan failure was considered. An IV injection of human immunoglobulin and glucocorticoid was given. She received continuous renal replacement therapy, hemodialysis, plasma exchange, repeated transfusions of washed red blood cells, fresh frozen plasma and cryoprecipitate, urinary alkalinization, liver protection, and other symptomatic treatment. On day 57, laboratory testing showed the following levels: RBC count 4.0 ×1012/L,Hb 112 g/L. SCr 110 μmol/L, ALT 13 U/L, AST 20 U/L, TBil 11.7 μ
  • 病例报告
    Zhang Yan;Zhang Yunzhou;Su Yingying
    . 2010, 12(4): 290-3.
    A 49yearold man with ventilatorassociated pneumonia received etimicin and meropenem. Three days later, sputum culture showed methicillin resistant Staphylococcus aureus (MRSA). Etimicin was withdrawn and then norvancomycin 400 mg dissolved in 0.9% sodium chloride 250 mL was given by an IV pump every 12 hours while meropenem was continued. After 13 days of therapy, the patient developed fever of 39.9 ℃, lamellar red rashes in his neck, chest, abdomen, and back which gradually progressed to involve his body from the neck to both groins. Routine blood tests revealed the WBC count of 1.39×109/L and proportion of neutrophiles of 0.06×109/L. Norvancomycin was withdrawn and cefoperazone sodium and sulbactam sodium was given via an IV pump, while meropenem use was maintained. Meanwhile he was given cimetidine and filgrastim. Four days later, almost all rashes disappeared. Eleven days later, the counts of WBC and proportion of neutrophiles returned to normal. Subsequently, norvancomycin was discontinued and the abovementioned symptoms did not recur and the routine blood examination results were within the normal range.
  • 论著
    Zou Deling;Liu Xingli;Fang Yue;Chen Yanli;Geng Ning;Pang Wenyue
    . 2014, 16(2): 86-5.

    ObjectiveTo compare the efficacy and safety of intravenous application of amiodarone or esmolol in elderly patients with ventricular arrhythmia following acute myocardial infarction (AMI) within 48 hours, and provide reference for safeuse of medication in clinical practice.MethodsElderly hospitalized patients with severe ventricular arrhythmia following AMI in department of Cardiology in Shengjing Hospital of China Medical University from January 2009 to June 2013 were enrolled into the study. The patients were divided into amiodarone group and esmolol group. The patients in amiodarone group received intravenous injection of amiodarone 150 mg in 5% glucose solution 20 ml within 10 minutes, then an IV infusion of amiodarone 1 mg/min was given by syringe pump for 6 hours, then an IV infusion of amiodarone 0.5 mg/min was given for 24-48 hours. After finishing the intravenous application, the patients were given amiodarone orally 0.2 g thrice daily for 7 days. The patients in esmolol group received intravenous infusion of esmolol 0.5 mg/kg within 1 minute, then a venoclysis of esmolol 0.1 mg/(kg·min) was given by syringe pump for 6 hours, then a venoclysis of esmolol 0.05 mg/(kg·min) was given for 24-48 hours. After finishing the intravenous application, the patients were given metoprolol orally 25 mg, twice daily for 7 days. The patient who still had ventricular tachycardia after intravenous application of amiodarone or esmolol for 6 hours in amiodarone group or esmolol group should receive the above-mentioned esmolol or amiodarone treatment, respectively. The efficacy and safety within 48 hours between the 2 groups were compared. ResultsThe effective rate in amiodarone group and esmolol group within 48 hours were 92.1% (35/38) and 75.0 (27/36), respectively (P=0.046). The incidence of adverse reactions in the 2 groups were 39.5% (15/38) and 19.4% (7/36), respectively (P=0.060). Two patients who had accompanied heart failure in the amiodarone group developed acute liver injury 24 hours after intravenous application. Two weeks later, their liver function returned to normal after drug withdrawal and symptomatic treatment.ConclusionsThe effective rate of intravenous application of amiodarone was higher than that of esmolol in treatment for elderly patients with ventricular arrhythmia following AMI. Amiodarone and esmolol are relatively safe. The liver function should be monitored in the elderly AMI patients when intravenous application of amiodarone were given. Once liver injury occurs, the drug should be discontinued immediately and the symptomatic treatment should be given.

  • Adverse Drug Reactions Journal. 2020, 22(3): 139-141. https://doi.org/10.3760/cma.j.cn114015-20200214-00115
    新型冠状病毒肺炎疫情的暴发使肿瘤患者的药物治疗受到影响。中国药理学会药源性疾病学专业委员会肿瘤分会专家组从落实“长处方”政策、关于用药延迟或漏用的处理、关于肿瘤患者感染新型冠状病毒的处理、药物治疗方案选择、药物使用管理以及药物不良反应监测和管理等几个方面对疫情防控期间肿瘤患者药物治疗管理提出了具体建议。
  • 调查研究
    Li Yongyu;Chen Liju;Liu Shangyun
    . 2003, 5(5): 306-308.
    Objective:To investigate adverse effects following administration of Shuanghuanglian.Method:1204pediatric inpatients were treated with Shuanghuanglian due to acute respiratory infections and its adverse reactions were analysed statis-tically.Re sults:The ADR occurance rates were8.39%(101out of1204cases),specifically9.48%in children receiving mixed use of Shuanghuanglian and antibiotics and6.04%in children taking Shuanghuanglian alone.The difference between the two was significant (P<0.05).The adverse effects of Shuanghuanglian were mainly rash and gastro-intestinal disturbances.Con clu sion:More adverse reactions occurred in patients treated with Shuanghuanglian and antibiotics in mixed use than Shanghuanglian alone.
  • 安全用药
    . 2001, 3(4): 231-233.
  • 论著
    Xu Juan*;Zhao Hong;Su Li;Ji Bingxin;Hui Wuhan
    . 2006, 8(4): 252-254.
    Objective:To evaluate risk factors of infection in patients with idiopathic thrombocytopenic purpura(ITP)during treatment of glucocorticoids.Methods:The occurence of infections to 98 cases with ITP were analyzed retrospectively during the treatment of glucocorticoids.The relative risks to concomitance of diabetes mellitus and the age of patients were evaluated.The correlations between treatment duration and infection events as well as its severity were analyzed.Results:Twenty-one cases of 98 patients occurred infections and two patients of them died of severe infections during the treatment.The odds ratio of concomitance diabetes mellitus for infections was 14.709(95%CI,4.788-46.984,x2=25.107,P=0.000).The elderly patients were 4.754(95%CI,1.321-17.102,x2= 5.85,P=0.017).The correlations between treatment duration and infection events as well as its severity had statistical significance(r= 0.505,P=0.000 and r=0.515,P=0.000,respectively).Conclusion:Concomitance diabetes mellitus and the elderly of patients with ITP are risk factors for occurrence of infections during the treatment of glucocorticoids.There are closely correlations between treatment duration and infection events as well as its severity.
  • Wang Suhong, Cheng Yan, Yang Maoguang, He Yangfang, Shen Hong, Cai Hanqing
    Adverse Drug Reactions Journal. 2021, 23(8): 436-438. https://doi.org/10.3760/cma.j.cn114015-20201202-01203
    -An 82-year-old female patient received monotherapy with nivolumab (240-mg by an IV infusion on the firsr day, 14 days as a cycle) because of multiple metastases of central adenocarcinoma in the right upper lobe of the lung. After 8 cycles of immunotherapy (about 4 months), the patient developed severe nausea and vomiting. Laboratory tests showed random blood glucose 43.2-mmol/L and β-hydroxybutyric acid 5.3-mmol/L. Blood gas analysis showed pH 7.01, bicarbonate root 4.0-mmol/L, alkali residual -22.4-mmol/L, serum potassium 6.1-mmol/L, and lactic acid 2.9-mmol/L. The patient had no previous history of diabetes mellitus. Fulminant type 1 diabetes mellitus due to nivolimab was considered. Nivolumab was stopped and rehydration, hypoglycemia, acidosis correction, and other symptomatic treatments were given. Two days later, her symptoms were improved obviously. Laboratory tests showed fasting plasma glucose 15.8-mmol/L and β-hydroxybutyric acid 0.2-mmol/L. Blood gas analysis showed pH 7.39, bicarbonate root 21.2-mmol/L, alkali residual -3.8-mmol/L, serum potassium 4.3-mmol/L, and lactic acid 1.0-mmol/L.
  • 调查研究
    Wang Guishuang
    . 2003, 5(4): 234-237.
    Objective:To observe diammonium glycyrrhizinate for impaired liver function due to lamivudine-induced HBV mutation.Method:40HBV-mutation cases,because of taking lamivudine for over one year,were randomly divided into treatment group and control group,20each.Two groups all received liver-protective remedies,with or without diammonium glycyrrhizinate respectively.Re sults:15cases in treatment group returned to normal liver function and only9in control group did,showing remarkable difference(P<0.05).Conclusion:Diammonium glycyrrhizinate could improve the impaired liver function in patients with lamivudine-induced HBV mutation.
  • 病例报告
    Wang Yanhui
    . 2009, 11(3): 215-3.

    A 69-year-old woman with coronary heart disease and hypertension received captopril, atenolol, isosorbide dinitrate, and nifedipine for two years and more. After admission, enteric-coated aspirin 0.1 g once daily and SC low molecular weight heparin calaium 5 000 U once every 12 hours were added to her regimen due to unstable angina. The next day, her enteric-coated aspirin dosage was increased to 0.3 g once daily, and low molecular weight heparin calcium was changed to heparin sodium 800-1 500 U/h, which was administered via an intraveous infusion pump. Forty-eight hours later, heparin sodium was switched to SC low molecular weight heparin calcium 6 000 U once every 12 hours again. On day 5, the patient developed retroperitoneal hematoma, and the amount of bleeding was 1 000-1 200 ml. Entericcoated aspirin and low molecular weight heparin calcium were withdrawn. RBC suspension, batroxobin, and fluid expansion were given. On day 28 after hospitalization, a CT scan revealed that his hematoma was absorbed in some degree and she was discharged two days later. Two months after discharge, repeated CT scan showed that a greater part of hematoma was absorbed.

  • 调查研究
    Lai Beia;Zhang Chunmeia;Xia Qunb;Chen Yingjuana;Ma Yuqinga;Huang Ciboa
    . 2008, 10(3): 177-3.

    Objective: To investigate the eye disorders induced by hydroxychloroquine in treating rheumatic diseases. Methods: Eightthree hydroxychloroquinetreated patients with rheumatic diseases in our hospital were investigated from January 2003 to June 2007. The type and frequency of adverse reactions associated with hydroxychloroquine were analysed. Results: The initial dosage of hydroxychloroquine used in 83 patients was 200~400 mg/d, subsequent dosage was decreased to 100~200 mg/d. Of the 83 patients, 12 developed adverse reactions as follows: 5 cases (6.0%) of eye disorders, 3 cases(3.6%)of neurological disorders, 2 cases (2.4%) of gastrointestinal disorders, 1 case (1.2%)of skin rash, and 1 case (1.2%)of oedema. Of the 14 patients receiving visual field testing, one patient's visual field defect probably related to hydroxychloroquine, and another patient’s visual field defect possibly related to hydroxychloroquine. Conclusion: Hydroxychloroquine might induce eye disorders. It is relatively mild in severity, and improve after stopping hydroxychloroquine or decreasing its dosage.

  • 安全用药
    . 2005, 7(1): 26-29.
    许多药物可引起胰腺炎,本文通过查阅中国生物医学文献数据库和PUBMED近20年的有关文献,对可引起胰腺炎的主要药物进行回顾分析,以期对临床安全用药有所帮助。
  • 监测交流
    . 2005, 7(3): 223-225.
  • 综述
    . 2003, 5(4): 224-228.
    应用rhGM-CSF或rhG-CSF治疗由药物或KOSTAMAN综合征等引起的粒细胞减少症疗效较明确,可明显降低死亡率,两者之间无明显差异;白细胞缺乏合并真菌感染,rhGM-CSF可加速中性粒细胞恢复,缩短真菌清除时间,与抗感染药合用可提高疗效;两者单独使用治疗再障可提高粒细胞数,降低感染率;与EPO、ALG/ATG联合治疗再障或重型再障,实验组与对照组有显著性差异,生存率明显提高;在强化免疫抑制的基础上联用治疗重型再障,实验组优于对照组,在提高缓解率、降低死亡率方面具有重要的临床意义。有学者指出rhGM-CSF在体内外对肺鳞状细胞癌的侵袭有促进作用。临床常见不良反应有发热、骨痛、过敏反应,罕见的不良反应有Sweet综合征、类白血病反应、血压下降、癫痫发作等。
  • 会议纪要
    Wu Xiaoyan
    . 2014, 16(3): 187-3.
  • ie Fujun, Tian Mei
    . 2015, 17(6): 461-462.
    A 63-year-old male patient with hypertension received oral amlodipine besylate 5 mg once daily, telmisartan 80 mg once daily was added to his regimen because of the blood pressure variability. Two months later, his alanine aminotransferase (ALT) was 543 U/L and aspartate aminotransferase (AST) was 311 U/L. Amlodipine besylate and telmisartan were stopped and switched to fosinopril 10 mg once daily. After eight weeks, laboratory tests revealed the following levels: ALT 19 U/L, AST 25 U/L, γ-glutamine transferase 34 U/L, alkaline phosphatase 68 U/L, total bilirubin 14.8 μmol/l, and direct biliru-bin 2.6 μmol/L. Amlodipine besylate 5 mg once daily was readministrated due to elevated blood pressure. After 3 and a half months, his liver function reexamination showed the following levels: ALT 13 U/L, AST 28 U/L, γ-glutamine transaminase 18 U/L, alkaline phosphatase 61 U/L, total bilirubin 10.6 μmol/l, direct bilirubin 2.4 μmol/L.
  • 病例报告
    Song Yan;Li Jijun;Li Xueyi;Chen Fengkun;Zhang Yiyan;Zhao Changzheng;Li Xiaorui
    . 2007, 9(6): 427-428.
    A 48-year-old women with chromic renal failure underwent dialysis therapy.She was given oral fenofibrate 200 mg every night for treating elevated blood lipid.Before administration,laboratory test showed the following vaules:Hb 97 g/L,PLT 202×109/L,Cr 907 μmol/L,BUN 30.62 mmol/L,TG 2.56 mmol/L,TC 5.4 mmol/L,ALT 16 U/L,AST 37 U/L,CK 52 U/L,and LDH 182 U/L,and serum electrolyte concentrations were normal.After 11 days of treatment,she developed hypodynamia,general muscular soreness,dark urine,and the urine volume decreased from 1 800 ml/day to 250 ml/day.The laboratory examinations revealed the levels as follows:Hb 79 g/L,PLT 102×109/L,Cr 1 112 μmol/L,BUN 37.1 mmol/L,K+ 8.7 mmol/L,CK 1 979 U/L,ALT 619 U/L,AST 1 880 U/L,LDH 3 470 U/L.The urine routine test showed protein(+) and RBC(┼┼┼).Arterial blood gas analysis revealed a pH level of 7.503,a partial carbon dioxide pressure level of 36.1 mmHg,a partial oxygen pressure level of 55 mmHg,and an oxygen saturation of level 0.863.She was diagn…更多osed as a case of rhabdomyolysis with liver and renal functional damage.Fenofibrate was stopped immediately.The patient was underwent hemodiafiltration.Six days later,her myalgia and debilitation improved.Her urine volume returned to 650 ml/d.Eight days later,her Hb,PLT,and Cr normalized.Twelve days later,her liver function returned to normal limits.
  • 病例报告
    Dai Yihui;Wang Xiaohong
    . 2007, 9(3): 209-210.
    A 75-year-old man with cerebral infarction in convalescence was administered with IM recombinant human interferon α-2b three million IU. About 20min later, he developed shakes, dyspnea, disable of lying flat, and cold sweat. Examination revealed a body temperature of 38.5℃, a BP of 200/100mmHg, a respiratory rate of 40 breaths/min, and a heart rate of 130 beats/min. He presented with trance, wet rales with wheeze in the inferior part of the lungs. An ECG showed complete left bundle-branch block and sinus tachycardia. After receiving symptomatic therapy, he improved gradually.
  • Wang Hongyana;Lin Zhusenb;Zhu Xiaofaa;Rui Menga;Hua Cana
    Adverse Drug Reactions Journal. 2009, 11(6): 434-2.
    A 91yearold man with bullous pemphigoid took longterm oral prednisone acetate tablets 5 mg/d. He received sustainedrelease sodium valproate 250 mg once daily for epileptic seizure. Five months later, the dosage was increased to 500 mg once daily. After 2 weeks, the patient experienced 3 tarry stools. Laboratory tests revealed the following levels: Hb 84 g/L, PLT 45×109/L; stool occult blood (+). Sustainedrelease sodium valproate tablets was decreased to 125 mg once daily and symptomatic therapy was given. Seven days later, his platelet count normalized and upper gastrointestinal haemorrhage subsided.
  • 病例报告
    Wang Xueni;Liu Ze;Wang Wei;Wang Luni
    . 2011, 13(4): 256-2.

    A 59-year-old man developed a temporary skin rash on his lower limbs after taking carbamazepine 0.1 g 1-2 times daily for seven days for tinnitus. His rash disappeared after withdrawal of carbamazepine. Subsequently, he was hospitalised with worsening tinnitus and received oral carbamazepine 0.1 g twice daily and oral mecobalamin 1 mg thrice daily. On day 2 of admission, his temperature was 39.2 ℃ and, on day 3, he presented with a red maculopapular rash on his face, body, and both knees. Biochemical blood tests revealed the following values: ALT 359 U/L, AST 137 U/L, γ-GT 506 U/L, and LDH 273 U/L. Carbamazepine and mecobalamin was stopped. Methylprednisolone and anti-allergic therapy were given. Two day later, his temperature normalized and, five days later, rash and hepatic function improved gradually. On day 9 of admission, the patient had a fever again with a temperature of 38.1 ℃. Later, his rash recurred and progressed to involve his entire body. Laboratory tests showed the following levels: WBC 13.78×109/L with eosinophils 0.113, ALT 187 U/L, AST 45 U/L, γ-GT 374 U/L, and LDH 239 U/L. Carbamazepine-induced hypersensitivity syndrome was diagnosed. Methylprednisolone and human immune globulin were given and his rash and hepatic function improved. On day 16 of admission,the rash reappeared on his lower extremities, and then resolved after administration of methylprednisone and symptomatic treatment.

  • 安全用药
    . 2006, 8(1): 30-32.
    H1受体拮抗剂能与组胺竞争效应细胞上的的组胺H1受体,使组胺不能同H1受体结合,从而抑制其引起过敏反应的作用。近年来,组胺H1受体拮抗剂引起的不良反应已有报道,主要为中枢神经抑制作用,体重增加、心律失常、肝肾毒性等。本文就其不良反应及合理应用作一概述,旨在为临床安全用药提供参考。
  • 病例报告
    . 2002, 4(2): 121-122.
  • 临床论著
    Li Xiuhea;Du Juana;Yang Lia;Yang Pinga;Zhong Jiaqia;Zhou Kuna;Gao Wenwena;Ying Donga;Zhu Xiaofana;Zou Yaoa
    . 2009, 11(2): 82-5.
    Objective: To study the effects of highdose methotrexate on liver and renal function in children with acute lymphoblastic leukemia. Methods:From March 2004 to May 2008, 165 hospitalized children with acute lymphoblastic leukemia were enrolled in the study and divided into two groups: the 3 g/m2 dose group (119 cases) and the 5 g/m2 dose group (46 cases). The 3 g/m2 dose group comprised 64 men and 55 women with average age of(104.88±21.40)months. The 5 g/m2 dose group comprised 37 men and 9 women with average age of(101.57±20.43)months. The drug administration was as follows: A bolus dose of onesixth of a total dose of methotrexate 3 g/m2 or 5 g/m2 was infused intravenously and was completed within 30 minutes, then the rest fivesixths dose was infused intravenously and was completed within 23.5 hours, while an IV infusion of 5% sodium bicarbonate 3~5 ml/kg was given until the blood methotrexate concentration was < 0.1 μmol/L and urinary pH was 6~8. An IV fluid hydration 2~3 L/m2 daily was given. An IV calcium foliate was given 36 hours after methotrexate administration for rescue. A total calcium foliate dose was 3%~5% of methotrexate dose, and the total dose was divided into 6~8 doses, one dose every 6 hours was given, and the initial dose was double. An IV infusion of reduced glutathione 0.6~1.2 g/d and an IV infusion of polygene phosphateidylcholine 232.5~465 mg/d were given for 10~14 days, respectively. Blood methotrexate concentration was measured 24, 36, 48, 72, and 96 hours after administration. Liver and renal function was recorded before and 2~7 days after methotrexate administration, as well as after chemotherapy completion. The urinary volume and pH were recorded 24 hours after chemotherapy initiation. Results: Blood methotrexate concentrations 24, 36, and 48 hours after administration in the 5 g/m2 dose and the 3 g/m2 dose groups were(130.99±67.23)μmol/L,(1.95±0.98)μmol/L,(2.13±3.03)μmol/L, and(55.02±29.46)μmol/L,(1.22±0.75)μmol/L,(1.28±2.75)μmol/L, respectively. The differences were statistically significant(P<0.01, P<0.05, P<0.05). During chemotherapy, γ-GT, TBill, and DBill levels in the 5 g/m2 dose and the 3 g/m2 dose groups were respectively(63.94±76.41)U/L,(24.87±42.91)μmol/L,(12.19±29.92)μmol/L, and(40.72±35.34)U/L,(13.01±6.26)μmol/L,(4.39±2.59)μmol/L, the differences were statistically significant (all P<0.01). The ALT, AST and ALP levels in the 5 g/m2 dose and 3 g/m2 dose groups were respectively (187.29±171.18)U/L, (85.47±111.59)U/L,(141.71±69.24)U/L, and(165.93±178.84)U/L,(73.45±82.42)U/L,(138.60±59.92)U/L, the differences were statistically significant (all P<0.05). There were no statistical differences between during treatment and before treatment in both groups, as well as between both groups during treatment (all P>0.05). After liverprotective treatment, the ALT, AST and ALP levels decreased markedly, and the ALT, AST and ALP levels in the 5 g/m2 dose and 3 g/m2 dose groups were respectively(47.86±37.84)U/L,(24.00±10.78)U/L,(115.40±34.43)U/L and(75.16±68.52)U/L,(32.78±27.65)U/L,(151.27±60.18)U/L, and the differences were statistically significant (all P<0.05). In the first and second days, the fluid output in the 5 g/m2 dose and 3 g/m2 dose groups were respectively (3 673±974) ml,(4 216±1 189)ml and(3 236±1 039)ml,(3 832±1 134)ml, the fluid output was higher in the 5 g/m2 dose group than in the 3 g/m2 dose group, and the differences were statistically significant (P<0.05). No marked changes in urinary pH were found. Conclusion: Highdose methotrexate can cause liver damage in children with acute lymphoblastic leukemia, and the intensity of damage is doserelated. Reduced glutethine plus polygene phosphateidylcholine has protective effects to liver.
  • 实验论著
    Bai Shuyuan;Wang Peichang
    . 2009, 11(5): 325-5.

    Objective: To investigate the distribution and drug resistance of 1103 strains of bacteria isolated from urine culture in order to provide a basis for appropriate selection of antibacterials in clinical practice. Methods:The urine samples from the outpatients and inpatients in our hospital from September 2006 to August 2008 were cultured and 1103 strains of bacteria were isolated. The identification of bacteria and antibacterial sensitivity tests of the isolates were performed by a routine method and VITEK 32 automatic measurement system. The results were evaluated according to NCCLS/CLSI 2006. Results: Among 1103 strains of bacteria, 647(58.7%) strains were Gramnegative bacilli and 456(41.2%) were Gram-positive coci. The first 5 bacteria isolation rates were Escherichia coli (427 strains, 38.7%), Coagulase negative staphylococcus (154 strains, 14.0%), Enterococcus faecalis (137 strains, 12.4%), Staphylococcus aureus (75 strains, 6.8%), and Enterococcus faecium (63 strains, 5.7%). Among the 1103 cases of patients whose urine culture was positive for bacteria, 448 (40.6%) cases were males and 655 (59.4%) were females; 1014 (91.9%) cases were inpatients and 89(81%) cases were outpatients. The first three wards to bacteria isolation rates were the ICU (41.6%), general geriatric wards (116%), and internal neuropathic wards (10.9%). ESBLsproducing strains of E. coli were 44.7% (191/427) of E. coli and ESBLsproducing strains of K. pneumonia were 65% (39/60) of K. pneumonia. The drug resistance rate of ESBLsproducing strains to 15 antibacterials was higher than that of ESBLsnon-producing strains, but both were sensitive to imipenem. Oxacillin-resistant strains of Coagulase negative staphylococci(ORCNS) were 76.0% (117/154) and oxacillin-resistant strains of staphyococcus aureus(ORSA) were 57.3% (43/75) . Antibacterial sensitivity tests revealed that E. coli and K. pneumonia were sensitive to imipenem (resistance rate was zero). The resistance rate of acinetobacter to imipenem was the lowest and it was 26.7%. The resistance rate of Pseudomonas aeruginosa to piperacillintazobactam was the lowest and it was 7.4%. The resistance rate of Proteus mirabilis to cepholosporines was 0~2.9%; ORSA and ORCNS were all sensitive to vancomycin(resistance rate was zero); the resistance rate of Enterococcus faecalis to nitrofurantoin was 2.2%. Conclusion: Resistant strains isolated from urine culture is tending increasingly. Appropriate drug selection in clinical practice should be based on the results of antibacterial sensitivity tests in order to avoid the development of resistant strains.

  • 论著
    wang Lina①;wu Yubo①;Zhao Jinpeng②;Guan Yinghui②;Jin Hui①;Jin Mingji①;Yang Hong①
    . 2006, 8(6): 410-414.
    Objective:To study the effect of osmotic pressure reduction of mixed parenteral nutrition solution on vessel irritation. Methods:Ninety patients performed with radical operation for advanced gastric carcinoma were divided into 3 groups:peripheral vein administration group,central vein administration group,and routine supplemental solution control group; each group had 30 cases. The patients in the two administration groups were given mixed parenteral nutrition solution and enteral nutrition for 5 days before operation; mixed parenteral nutrition solution on the first day after operation,the enteral nutrition used as an adjunct to mixed parenteral nutrition solution on the third day after operation,and mixed parenteral nutrition solution used as an adjunct to enteral nutrition on the seventh day after operation. The patients in the control group were given routine supplemental solution within one week ofter operation.The content of glucose and amino acid for mixed parenteral nutrition solution in the peripheral vein administration group was < 10% and 3% respectively (osmotic pressure was 900~950 mosm/L). The preparation of mixed parenteral nutrition solution for the central vein administration group was made according to the standard prescription (osmotic pressure was 1200~1300 mosm/L). The nutritive indexes were measured on the day before operation,the third day and the fifth day after operation. The incidence of complications including phlebalgia,extravasation,phlebitis,and superficial phlebothrombosis was observed. Results:The serum transferrin and albumin levels were increased on the seveth days after operation (P<0.01),and the incidence of complications after operation was lower (P=0.024) in the peripheral vein administration group compared with the central vein administration group. There were no statistical differences between the two administration group in their serum transferrin and albumin levels. No severe complications were found in the peripheral vein administration group. Conclusion:The osmotic pressure reduction of mixed parenteral nutritionsolution may decrease the vessel irritation and beneficial to safe drug use.
  • 专题讲座
    . 2000, 2(4): 273-276.
    本文从传统药物不良反应评价的局限性出发,提出生命质量评价是药物不良反应评价有益的必要补充。根据目前学术界对生命质量观的认识,概述了生命质量的概念、评价内容和评价方法。最后对生命质量评价在药物不良反应中的应用前景进行预测。
  • 调查研究
    Zhao Hui;Wang Huizhu
    . 2003, 5(4): 229-231.
    Objective:To discuss the relation between glucocorticoid therapy and secondary infection(SI )of SARS patients.Method:Bacterial cultures of blood,urine,stool and sputum of the SARS patients were made in our hospital from26March to24May2003,with statistic analysis of the cases treated with glucocorticoid.Results:There were80individual strains of bacteria isolated from253cases.174patients of them were treated with glucocorticoid.The SI rate was19.0%,while the SI rate of79patients without steroids treatment was7.6%.Statistics showed the significant difference between the two (P<0.01).In severe SARS SI rate was25.9%,for the rest,12.9%.SI rate for patients under the low dose was10.3%and under the high dose,23.3%.Conclusion:The SI rate in SARS patients with glucocorticoid treatment was higher than the rate without it.The severe paitents were much easier infected after steroids because of their suppressed immunity.So the glucocorticoid should be used carefully.
  • 病例报告
    QU Cai-hong;QIN Feng;SONG Mei-hua
    . 2012, 14(3): 179-3.

    A 48-year-old male patient underwent resection of space-occupying lesion in his left tempus because of encephalopyosis with secondary epilepsy. The patient received an IV infusion of monosialotetrahexosylganglioside 40 mg and then an Ⅳ infusion of benzylpenicillin sodium 32 million U (negative skin test) on the first day after operation. About 5 minutes after infusion completion, the patient developed agitation, lip cyanosis, coarse breath sound with audible wheezes in the lungs. His respiratory rate (RR) increased to 30-40 breathes/min, his heart rate (HR) increased to 178 beats/min, his blood pressure decreased to 80-88/48-60 mm Hg, and his blood oxygen saturation was 0.60. The patient immediately received oropharyngeal ventilation tube, sputum aspiration, mask oxygen, tracheal intubation, and assisted breathing by a ventilator, followed by an IV infusion of dopamine 100 mg, metaraminol 40 mg, methylprednisolone 0.5 g, an IV bolus of deslanoside 0.2 mg and dexamethasone 4 mg. Two hours later, his HR and RR decreased to 110 beats/min and 19 breathes/min, respectively, and his blood pressure and blood oxygen saturation increased to 125-135/70-90 mm Hg and 1.00, respectively. His vital signs were stable. The anaphylactic shock was suspected to be associated with benzylpenicillin sodium. On the second day after operation, benzylpenicillin sodium was withdraw and an IV infusion of monosialotetrahexosylganglioside 40 mg in 0.9% sodium chloride solution 100 ml was continued. About 10 minutes later, the patient developed agitation and tachypnea again, his HR increased to 160 beats/min, his blood oxygen saturation decreased to 0.85, and his blood pressure decreased to 77/45 mm Hg. The IV infusion was stopped immediately. Symptomatic treatment such as mechanical ventilation, increasing blood pressure, decreasing HR, anti-anaphylaxis, and anti-inflammatory agents was given. Forty minutes later, his HR and RR decreased to 110 beats/min and 18 breathes/min, respectively, and his blood pressure and blood oxygen saturation increased to 110-145/60-90 mmHg and 0.98, respectively. The patient ’s vital signs were stable.

  • Jiang Chunling;Yang Siyun
    Adverse Drug Reactions Journal. 2010, 12(2): 132-2.
    A 29yearold man with tuberculosis received one capsule of compound rifampicin (each capsule contains rifampicin 600 mg and isoniazid 600 mg ) every other day. After 3 months of therapy, his symptoms improved and drug was stopped by himself. One year later, the patient developed cough, night sweats and other symptoms again. So he took compound rifampicin capsules at the abovementioned therapeutic dosage by himself. After 8 days of treatment, nausea, vomiting, lumbago, edema of face and both lower extremities, decreased urine output, and dark urine appeared. Laboratory examinations revealed the following values: BUN 21.2 mmol/L, SCr 877.8 μmol/L, protein (+), and occult blood (+ + +). On ECT test, his left and right kidneys showed GFR levels of 21.11 ml/min and 20.98 ml/min, respectively. Rifampicin was withdrawn and hemodialysis was given. Meanwhile he was treated with symptomatic and supportive therapies. Twentyfive days later, his symptoms improved.
  • 病例报告
    Aygul·Yunus①;Fang Baomin②;Yang Yimeng②;Zhang Yatong③
    . 2007, 9(6): 440-441.
    A 68-year-old woman received a diagnostic treatment with oral isoniazid 0.3 g,ethambutol 0.75 g,and rifampicin 0.45 g for exclusion of tuberculosis.Five minutes after administration,she suddenly developed dizziness.Her blood pressure was 80/57 mmHg and oxygen saturation was 0.90.After a ten-minute infusion of glucose and sodium chloride injection,her blood pressure returned to normal value and the symptom was relieved.The next day,rifampicin was discontinued and the other two drugs were continued.Ten minutes after administration,the patient developed dizziness,polyhidrosis,coldness of the extremities,and a BP of 64/42 mmHg.She was treated with fluid supplementation,oxygen,adrenline,dopamine,and metaraminol.Two hours later,her BP increased to 102/60 mmHg.Afterwards,isoniazid and ethambutol were both discontinued and replaced with oral rifampicin and pyrazinamide.No syptoms mentioned above recurred.
  • 综述
    . 1999, 1(3): 145-150.
    拉米夫定(lamivudine)是新一代核苷类抗病毒药。其不良反应较轻微,发生率也不高,病人的耐受性较好。本文综述了1992年以来文献报道的与拉米夫定有关的少见不良反应,提示临床医生在拉米夫定长期应用期间,以及与其他药物联合应用时注意。
  • Qi Yanxia, Qin Yuhua
    . 2016, 18(1): 64.
    A 30-year-old female patient with pelvic inflammation received levofloxacin tablets 0.5 g once daily and ornidazole dispersible tablets 0.5 g twice daily for 14 days. On day 13 of drug use, the patient developed aching limbs and fatigue. The symptoms were worsened after drug withdrawal. Laboratory tests on day 12 after drug withdrawal showed the following values: creatine kinase(CK) 939 U/L, creatine kinase isoenzyme(CK-MB) 41.3 U/L, lactate dehydrogenase(LDH) 313 U/L. The patient was diagnosed as rhabdomyolysis. She was informed to drink plenty of water, received sodium bicarbonate tablet (0.5 g, thrice daily) and coenzyme Q10 tablet (10 mg, thrice daily). Two weeks later, the values of CK, CK-MB, and LDH were 96 U/L, 21 U/L, and 287 U/L, respectively. Her symptoms of aching limbs and fatigue disappeared. The results of subsequent visit three months later showed that the above mentioned parameters returned to normal.
  • Zhu Yuanchao, Liang Liang, Zhao Ming, Zhao Zinan, Yang Liping
    . 2016, 18(5): 342.
    ObjectiveTo analyze the effect of clarithromycin on blood concentration of cyclosporine in hematopathy patients.MethodsData of hematopathy patients, who received cyclosporine monotherapy at first and then followed by cyclosporine+clarithromycin combination therapy because blood concentration of cyclosporine could not meet the requirement with cyclosporine monotherapy, hospitalized in Beijing Hospital from February 1st 2012 to January 31st 2015 were collected and retrospectively analyzed. Analysis indicators included: (1) cyclosporine dose, cyclosporine concentration, cyclosporine dose/concentration before and after the combination therapy, cyclosporine concentration with the same dose of cyclosporine before and after the combination therapy; (2) rate of reaching standard blood concentration of cyclosporine before and after the combination therapy; (3) adverse drug reactions.ResultsA total of 13 patients were enrolled in this study. Of them, 5 patients were male, 8 were female, and  the average age was (65±16) years (36-83 years). Eleven of 13 patients were diagnosed as aplastic anemia, 2 were diagnosed as myelodysplastic syndrome. A total of 189 times of blood concentration of cyclosporine monitoring in 13 patients were performed, 3-43 times were performed in each patient [mean(15±13)times] and the median time was 11; 73 times were performed before the combination therapy, 1-21 times in each patient and the median time was 4; 116 times were performed after the combination therapy, 1-25 times in each patient and the median time was 5. Cyclosporine total dose and daily dose after receiving combination therapy were lower than those before combination therapy [(187.5±32.3) μg·L-1 vs. (153.0±35.4) μg·L-1, (2.9±0.6) mg·kg-1·d-1 vs. (2.3±0.6) mg·kg-1·d-1, P<0.001]; cyclosporine concentration and cyclosporine concentration/dose after receiving combination therapy were higher than those before combination therapy [(207.6±49.8) μg·L-1 vs. (116.3±34.1) μg·L-1, (87.3±25.9) vs. (40.6±9.1)] (P<0.001). Blood concentration with the same dose of cyclosporine before and after the combination therapy were (105±44) and (233±80) mg·kg-1·d-1 and the blood concentration of cyclosporine+clarithromycin treatment were (2.5±1.0) times of cyclosporine monotherapy. Rates of reaching standard cyclosporine concentration were 15.4% (2/13) and 76.9% (10/13) before and after the combination therapy (P=0.005). There were no significant differences in blood pressure, serum creatinine, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, and γ-glutamyl transferase after cyclosporine monotherapy and cyclosporine+clarithromycin combination therapy for 1 month (all P>0.05).ConclusionCyclosporine and clari-thromycin combination therapy may increase the cyclosporine blood concentration safely and effectively and reduce cyclosporine dose.
  • Guo Chenyu, Zheng Wenwen, Li Kaimin, Lu Congxiao
    . 2016, 18(3): 216.
    A 58-year-old male received a continuous intravenous fusion of sodium valproate 33.6 mg/h for 3 days because of epileptic seizure. Seven days later the patient underwent the the excision of lesion of left temporal lobe. The day after operation his platelet count (PLT) decreased from 242×109/L which was tested on hospitalization to 100×109/L, but he did not receive any treatment for the decreasing PLT. He received the continuous intravenous infusion of sodium valproate according to the primary dose again for 4 days. His PLT decreased to 72×109/L, prothrombin time (PT) prolonged to 20.7s from 13.4 s, and fibrinogen (FIB) decreased from 2.08 to 0.99 g/L. The patient was diagnosed as thrombocytopenia and hypofibrinogenemia induced by sodium valproate. Sodium valproate was  withdrawn and cryoprecipitate 6.0 U was given. One week after drug withdrawal the laboratory tests showed the following values: PLT 294×109/L,PT 13.2 s,and FIB 2.57 g/L.
  • . 2017, 19(5): 375.
  • 病例报告
    Zhang Zheng
    . 2007, 9(5): 363-364.
    A 43-year-old woman received 2%lidocaine solution 3 ml for local oral anesthesia.Two minutes later,she developed dizziness and nausea,and then progressed to unconsciousness,pale,sweating,short of breath,and cyanosis of the lips.Her heart rate WaS 145 beats/min,and her blood pressure was undetected.After treatment with epinephrine,dopamine,dexamethasone,and rapid fluid resuscitation,the patient's consciousness recovered and her blood pressure and heart rate returned to normal limits.However,2 hours later,the patient developed dyspnoea,orthopnea,coughing up pink frothy sputum.Her finger tip pulse oxygen saturation (SpO2) decreased to 0.78 during inhalation of oxygen 5 L/min.Her blood pressure increased to 180/110 mmHg,and heart rate Was 140 beats/min.Extensive rales and wheezes in the lungs were heard.After receiving nitroprusside sodium,lanatoside C,and furosemide thempy,the patient’s symptoms disappeared.
  • 病例报告
    Bi Jinlian
    . 2007, 9(4): 271-271.
    A 40-year-old man with fracture of left thumb was given intravenously ossotide injection 50 mg once daily.On day 6 during the infusion,the patient suddenly developed severe thoracalgia,abdominalgia,and lumbago,a fever(T 39 ℃),generalised cyanosis,and dyspnea.Two hours later,his blood pressure was decreased from 140/110 mmHg on admission to 70/50 mmHg,accompanied by unconsciousness and gatism.After discontinuation of ossotide injection instantly,he received antishock therapy.One hour later,he recovered.His blood pressure was 100/70 mmHg and respiration rate was 20 breaths/min.
  • . 2013, 15(5): 279-1.
  • 调查研究
    Chen Linzhen;Li Xiaosui;Li Ruiying
    . 2005, 7(5): 330-332.
    Objective: To investigate the prevalence and the drug sensitivity of staphylococcus in clinic so as to provide scientific basis for rational drug use. Methods: 351 staphylococcus strains isolated from inpatient specimens were identified,and screening test for methicillin-resistant staphylococcus(MRS), qualitative determination for β-lactamase and testing for bacterial sensitivity to antimicrobial agents were performed. Results: Staphylococcus were dramatically found in respiratoty infection, accounting for 65.0% (228/351). The isolation rate of MRS was 85.2% (299/351)and MRSA 81.0% (145/179). Staphylococcus strains with positive β-lactamase were 91.5%(321/351). The resistance rates of staphylococcus to 8 antibiotics were 68.9% to 97.7%, except vancomycin. Conclusion: MRS is one of the important pathogens causing nosocomial infection and its infection rate is trending upward.
  • 病例报告
    . 2003, 5(6): 403-405.
  • 调查研究
    He Suiping;Zhen Jiancun;Ma Zhenzi
    . 1999, 1(1): 25-27.
    objective: To understand the relationship between digoxin toxicity and serum digoxin concentration. Methods: The criterion for diagnosis of digoxm toxicity was established. The serum digoxin concentration was measured by fluorescence polarization immunoassay. Results: 31 of 213 patients receiving digoxin were intoxicated. The incidence of toxicity was 14.5% . Conclusion: The occurence of digoxin toxicity is close related to serum digoxin levels, and the risk of digoxin toxicity is increased with the increase of serum digoxin concentration.
  • 安全用药
    . 2006, 8(5): 358-363.
  • 学术论坛
    Zhou Chaofana;Lin Yuhuab
    . 2008, 10(2): 104-6.

    Realgar (Xionghuang) has a history of two thousand years and more as a traditional Chinese medicine, and it was included in each edition of Chinese Pharmacopoeia from 1963 to 2005. Realgar is mainly used for treatment of snack and insect bite, parasitogenic abdominal pain, convulsions, and malaria. Recent studies suggest that realgar has antibacterial, analgesic and antiinflammatory effects as well as the effect of enhancing immunity; realgar preparations are effective for treating leukemia. The daily dosage of realgar is 0.05~0.1 g. Actually, according to incomplete statistics, the commonly used dosage of about 66 realgar preparations exceeds the dosage limit in Chinese Pharmacopoeia. The main composition of realgar is arsenic disulfide (As2S2). Despite lower toxicity of arsenic disulfide, acute or chronic poisoning can occur after high dosage or longterm use of realgar. And it might be related to soluble arsenic trioxide (As2O3) in realgar. Realgarinduced serious adverse reactions include hemorrhage, hepatorenal failure, paralysis of respiration centre, and death. The authors suggest that the scientific reassessment of its benefit and risk in clinical practice should be performed on the basis of a thorough investigation and study in the efficacy and safety of realgar and its preparations.

  • Wang Yu, Zhao Xinyan
    Adverse Drug Reactions Journal. 2023, 25(2): 65-68. https://doi.org/10.3760/cma.j.cn114015-20220804-00716
    Most patients with drug-induced liver injury (DILI) have a good prognosis. However, 11%-17% of the patients will suffer from chronic DILI, and 6%-10% will suffer from acute liver failure, even death or need for liver transplantation. In 2019, the incidence of DILI in China was 23.8/100-000 person year, which was far higher than that in western countries, so the study on DILI should not be ignored. This paper summarizes the hot issues in the field of DILI in recent years, mainly including the new diagnostic markers, the genetic susceptibility, the in vivo and in vitro models of idiosyncratic DILI, the diagnosis of chronic DILI, the treatment scheme, the prognosis model, the liver injury caused by immune checkpoint inhibitors, etc., in order to provide a reference for clinical workers in future research.
  • 论著
    Luo Leiming;Mao Li;Zhu Qiwei;Gu Jie; Li Yanhan;Zhang Ling;Zeng Qiang;Xue Hao;Zhu Bing;Yang Xue;Wu Hongmei;Ye Ping
    . 2008, 10(4): 0-0.

    Objective: To study the efficacy and safety of carvedilol for preventing recurrence of paroxysmal atrial fibrillation (PAF) in order to benefit rational and safe use of carvedilol. Methods: Fiftythree patients with PAF were enrolled in a prospective, randomized, parallel, controlled study, and assigned to two groups: the carvedilol (CAV) group (27 cases) and the metoprolol(MET)group (26 cases). The patients in both groups received carvedilol 25 mg daily or metoprolol 50 mg daily, respectively. Duration of treatment was 1 year. MMP2 and MMP9 expressions in peripheral blood monouclear cells, silent heart rate (SHR), left atrial diameter (LAD), left ventricular enddiastolic diameter (LVEDd), and left ventricular ejection fraction (LVEF) were measured before and after treatment. Atrial fibrillation (AF) recurrence parameters including AF recurrence rate, occurrence frenquency (OF), occurrence sustain time (OST) and occurrence ventricular rate (OVR) were all recorded during one year of therapy. Results: ⑴ In comparison of after treatment with before treatment, LVEDd and LVEF found no change in the two groups (all P>0.05); SHR was (68±12) beats/min and (61±9) beats/min in the CAV group, and (69±11) beats/min and (61±11) beats/min in the MET group, respectively, SHR was significantly slower after treatment than before treatment (all P<0.05); there was no significant change in LAD in the CAV group (P>0.05), but LAD in the MET group was markedly greater (P<0.01); MMP2 and MMP9 expressions before and after teatment were (138.5±56.4) ng/dl, (103.7±49.5) ng/dl and (19.6±11.1) ng/dl, (11.3±9.4) ng/dl in the CAV group, MMP2 and MMP9 expressions were markedly lower after treatment than before treatment (P<0.05, P<0.01), MMP2 and MMP9 expressions showed no significant decrease in the MET group (P>0.05). OF decreased significantly in the CAV group (P<0.01), but there was no marked difference in the MET group (P>0.05). ⑵ In comparison of both groups after treatment, LAD was marked lower in the CAV group than in the MET group (P<0.01), but there was no statistically difference in other parameters of heart morphology and function (all P>0.05); MMP2 and MMP9 expressions, OF and OST of AF were lower in the CAV group than in the MET group (P<0.01, P<0.05); and there was no significant difference for AF recurrence rate and OVR in both groups (all P>0.05). ⑶ A positive correlation was observed between OF and LAD (r=0.826, P<0.01), and the expressions of MMP2 and MMP9 (r=0.773, r=0.819, all P<0.01). ⑷ No severe AV block was found in both groups. The two drugs did not influence on the blood glucose levels. Conclusion: Carvedilol could be safely and effectively used for preventing recurrence of paroxysmal atrial fibrillation.

  • 病例报告
    Long Sen
    . 2008, 10(5): 0-0.

    A 30-year-old man was treated with antipsychotic drugs for depression. The patient had no history of hypertension and his blood pressure was normal before therapy. He started receiving monotherapy with clozapine 150 mg at noon and 225 mg in the evening, and his blood pressure was normal. On day 13 of clozapine treatment, fluoxetine 20 mg in the morning was added to his regimen. On day 2 of combination therapy, he experienced dizziness and a BP of 150/105 mmHg. After clozapine dosage was reduced to 125 mg at noon and 200 mg in the evening and fluoxetine dosage was increased to 40 mg, his blood pressure increased further to 160/110 mmHg. Therefore, fluoxetine was stopped and clozapine dosage was further reduced to 100 mg at noon and 175 mg in the evening. Two days later, his blood pressure normalized.

  • 调查研究
    Jiang Shuang;Wang Xiaobo;Xi Ronggang;Yang Dongcai
    . 2003, 5(1): 13-17.
    Objective: To specify clinical characteristics and causes of adverse reactions to cardiovascular drugs. Method: 739 adverse reactions to cardiovascular drugs were collected and analyzed from domestic articles in 1998-2001. Results: Adverse reactions to cardiovascular drugs occurred in the body's seven systems, with respiratory system in the highest proportion(29.8%) . Six groups of drugs were involed and ACEI was the main one for causing ADR (230 cases) . As for ADR intensity, severe reactions were showed in 46 cases, among them 15 deaths. Most of ADR were caused by oral administration(65.5%) and in age of 51 and upwards (78.9%). Conclusion:The occurrence of adverse reactions to cardiovascular drugs was related to drugs' pharmacology, route of administraction, interactions and patients' age, individual difference.
  • 调查研究
    Ma Guoer
    . 1999, 1(2): 104-105.
    Objective: To study the measures for the management of liver injury through antituberculosis treatment. Methods: An increase in aspartate aminotransferase (AST), ranging from 2-6 times the upper limit of the normal (ULN) was recorded in 18 patients. The former therapy was continued fully in 13 patients (AST 2×ULN4 × ULN), and a modified therapy (rifapentine instead of rifampicin) was reintroduced in the other 5 patients (AST 4×ULN6XULN). At the same time, all 18 patients were treated with drugs for liver protection. Results: Treatment was finished successfully in 17 patients. Only one old male patient who had a relapse didn' t finish the treatment because of nausea, bad appetite and jaundice. Conclusions: In spite of an increase in AST level to approximately 6×ULN during antituberculosis therapy, the therapy can be continued in full in most cases and the drugs for liver protection are necessary at the same time.
  • 论著
    Lui Shumin;Yao Zhuxing;Bai Qingyun;Xu Ying
    . 2006, 8(1): 17-19.
    Objective: To observe the effects of different dosages of cocklebur fruit (Fructus Xanthii) on body weight, serum transaminase and hepatic malonaldehyde level of mice. Methods: 60 mice were divided into 4 groups (15 mice each). The three treatment group (low, medium and high dosage) were fed 1.04 g/kg, 5.28 g/kg, 20.8 g/kg dosage of cocklebur fruit powerdered extract (1 g equivalent to 15 g crude drug) daily for 4 weeks respectively, while the control group was administered with physiological saline. The body weight, hepatic malonaldehyde and serum transaminase level were measured every week after drug administration. Results: The weight gain in the treatment groups was less than that in the control group in the first two weeks. The high dosage treatment group showed weight loss in the third week, and all treatment groups showed weight loss in the fourth week. A total increase in body weight of the treatment group was significant lower than that of the control group (P< 0.05 or P<0.01). The level of serum aspartate transaminase in the high dosage treatment group was much higher than that of the control group. The difference was significant (P<0.05). The hepatic malonaldehyde level of the three treatment groups were much higher than that of the control group,the comparison between the high dosage treatment group and the control group P< 0.001, the comparison between the low or medium dosage treatment group and the control group P< 0.05.Conclusion: A harmful effect of cocklebur fruit was found on mice gastro-in- testinal system, including lipid peroxidization in liver.
  • 病例报告
    ZHAO Shan-shan;ZHANG Li-li;ZHAO Ping;LI Jing
    . 2012, 14(4): 255-3.
    An 82-year-old male patient with incomplete intestinal obstruction developed unconsciousness, sweating, shortness of breath, and low blood pressure about 5 minutes after receiving an IV injection of iohexol 70 ml mixed with normal saline 30 ml for an abnormal contrast-enhanced CT scan. The patient was immediately given an IV injection of dexamethasone and adrenalin, an IV infusion of dopamine, an IV infusion of sodium bicarbonate, oxygen inhalation, intravenous nikethamide, flunarizine, atropine, and continuous closed-chest cardiac compression. He ultimately died despite resuscitation efforts. Autopsy showed epiglottis and throat edema, while no pathological changes, such as volvulus, intussusception, and intestinal necrosis were seen. Histopathology examination showed eosinophil infiltration in his throat, esophagus, liver, lung, and intestine, suggesting that the patient might die of allergic reactions to iohexol.
  • 病例报告
    Chu Yanqi
    . 2007, 9(4): 287-287.
    A 52-year-old man with colonic cancer was administered with IV oxaliplatin(Eloxatin)150 mg after operation.In the cycle 5,the patient received IV oxaliplatin(Aiheng)and developed cough and skin flush.In the cycle 6,he presented with skin flush,pruritus,cough,dyspnoea,and hypotension(63/45 mmHg)after 10 minutes of intravenous infusion of oxaliplatin(Eloxatin).Anaphylactic shock was diagnosed.The symptoms relieved after symptomatic therapy.
  • 病例报告
    Li Gang
    . 2007, 9(3): 181-181.
    A 63-year-old man ingested atorvastatin calcium 10mg once daily for decreasing the level of total cholesterol and triglycerides. 15 days later, laboratory tests revealed that his AST and ALT were increased from 35U/L to 153U/L and from 37U/L to 228U/L, separately. Atorvastatin calcium was withdrawn. The patient received glutathion therapy. After 5 days of therapy, his AST and ALT were decreased to 73U/L and 90U/L, separately. Thirty days later, the levels of AST and ALT were normal.
  • 中药不良反应
    Wu Yuntao;Cao Jingjing
    . 2007, 9(6): 443-444.
    An 81-year-old man with a history of coronary heart disease,hypertension,diabetes mellitus,and cerebral infarction for many years was given corticosteroids for treating pemphigoid for 5 months.Then he received 250 ml of IV Shenqifuzheng injection so as to improve microcirculation and enhance immunity.Seven hours later,he developed oozing of blood on the skin scabs of pemphigoid,gross haematuria,and sludged blood in the mouth.His platelet count decreased from 163×109/L to 5×109/L.Shenqifuzheng injection was stopped.The oozing of blood of his skin and mucosa stopped after treatment with batroxobin.He received IV plasma 230 ml,platelet suspension 24 U,and etamsylate 3 g.Then his skin and mucosa did not bleed,and the urine color turned pale yellow.The patient's platelet count gradually increased to normal limits.
  • Li Li, Liu Taotao, Jiang Xia
    . 2015, 17(4): 264.
    ObjectiveTo investigate the use of global trigger tool (GTT) for evaluating adverse drug events (ADE) in hospitalized patients.MethodsFourteen triggers were selected according to Institute for Healthcare Improvement Global Trigger Tool for Measuring Adverse Events and situation of medicine administration in China. Three hundred discharged patients′ medical records, coming from hospital information system of the First Affiliated Hospital of Guangxi Medical University from January to December 2013, were selected randomly and examined. The records with positive triggers were filtered and analyzed on estimation and classification of ADE as well as damage of organ and system. The detection rate of triggers was calculated and compared with the voluntary reporting rate of ADE in the same year.ResultsA total of 300 patients were involved in the 300 records. Of them, there were 59 patients with positive triggers accounting for 19.67% and 72  cases with positive triggers including 48 patients with only one positive trigger, 9 patients with 2 positive triggers, and 2 patients with 3 positive triggers. The cases with positive triggers were analyzed on estimation of ADE. Sixty-four ADEs were confirmed and these ADEs involved 49 patients. The detection rate of ADE was 16.33% (49/300). The 64 ADEs contained 53  ADEs (82.81%) of level E, 6 ADEs (9.38%) of level F, and 5 ADEs (7.81%) of level H. The most common damage of organ was gastrointestinal system and a total of 21 cases developed gastrointestinal damages. The clinical manifestations were vomiting (20 cases) and diarrhea (1 case). The voluntary reporting rate of ADE in the same year was 0.43%(286/66 395), compared with the detection rate of triggers (16.33%), the difference was statistically significant (χ2=1 479.589,P<0.001).ConclusionCompared with the voluntary reporting rate, GTT could find more ADE.
  • 安全信息
    . 2014, 16(2): 70-1.
  • 病例报告
    Liu Chenyun
    . 2007, 9(5): 370-370.
    A 42-year-old woman with hyperthyrosis and nodular goiter received thiamazole 10 mg thrice daily,leucogen,and prop- ranolol for one month.She developed asthenia,anorexia,dark urine,and severe yellowing of the skin.Laboratory tests revealed the following levels:ALT 1 670 U/L,AST 1 524.3 U/L,Tbil 289.3μmot/L,Dbil 129.3 μmol/L,ALB 28.9 g/L,and A/G 0.7.A type-B ultrasonogram showed the echo of her liver was coarse.Thiamazole was withdrawn and other drugs were continued.In addition,she received liver.Protective treatment.One month later,the patient’s symptoms improved gradually,and her liver function returned to normal levels.
  • 调查研究
    Pan Qiaoyi;Wang Lei;Yah Shufeng
    . 2000, 2(1): 28-30.
    Objective: To review the adverse reactions induced by quinolones and make safety assessment of the drugs on the market. Methods: Clinical reports on ADR of quinolones, published during the last five years, were collected and analysed by means of literature metrology. Results: In accordance with the incidence of ADR nofloxacin ranked the first, followed by ciprofloxacin, pipemidic acid, pefloxacin, ofloxacin and enoxacin. Various clinical manifestations were involved, mostly allergic reactions and neurological symptoms. Conclusion: Physician s attention should be drawn to ADR surveillance and rational medication.
  • 综述
    . 2000, 2(1): 1-5.
    本文介绍了ELITE-2试验结果和已出现的ADRs报告对“沙坦”类抗高血压药的临床应用、作用机制和前景产生的影响。同时也介绍了一种即将上市的新药奥培垂特。
  • 安全用药
    Lian Xiaolan
    . 2011, 13(4): 232-4.

    Thiourea antithyroid drugs have an inhibitory effect on the production of thyroid hormone and are used in the treatment of hyperthyroidism in clinical practice. The commonly used thiourea antithyroid drugs are methimazole and propylthiouracil. Their adverse reactions include drug eruption, granulocytosis, serious hepatic injures, ANCA-associated vasculitis and teratogenicity. Severe hepatic injures and ANCA-associated vasculitis are mainly related to propylthiouracil, while teratogenicity is caused by methimazole. Methimazole is a first-choice drug for treating children and non-pregnant women with hyperthyroidism, while propylthiouracil is a first-choice drug for treating pregnant and breast-feeding women. The measures of the prevention and treatment of adverse reactions to thiourea antithyroid drugs are as follows: rational drug use, regular monitoring, drug withdrawl immediately after developing related adverse reactions and treatment.

  • 论著
    Zhang Minyan
    . 2006, 8(1): 19-21.
    Objective: To study the effects of nitrofurazone and ephedrine nasal drops on mucociliary transport function in children. Methods: 6o children aged 10-14 years with eustachian tube dysfunction but without nasal disease were selected and administered nitrofurazone and ephedrine nasal drops (two drops three times daily for 10 days). Mucociliary transport rate (MTR) was measured by saccharin technique before drug administration, after a 10 days use of nitrofurazone and ephedrine nasal drops, and after a one month discontinuation of the drug. Results: The mean nasal MTRs were (12.56±3.82)mm/min and (8.04±2.12)mm/min before drug administration and after a 10 days use of the drug respectively. The difference was significant (P< 0.01). The MTRs was (11.21±2.52)mm/min after a one month discontinuation of the drug, which showed no significant difference from that before administration of the drug. Conclusion: A ten days use of nasal decongestants as nitrofurazone and ephedrine nasal drops may cause reversible inhibition of mucociliary transport function.
  • 不良事件
    . 2005, 7(3): 229-229.
  • 论著
    Zhou Ying;Huang Lihua;Liang Yan;Jiang Guangxia;Cui Yimin
    . 2009, 11(1): 9-4.
    Objective: To investigate the risk of developing secondary cancer in patients who had received Chinese herbal medicines containing aristolochic acid after kidney transplant. Methods: The data from the kidney transplant recipients in our hospital were collected from January 1, 2000 to December 31, 2007. The patients were divided into the following two groups: the receiving aristolochic acid group and naive aristolochic acid group. The incidence and relative risk of secondary cancer in kidney transplant recipients in both groups were analysed. Results: The total kidney transplant recipients were 279 [147 men and 132 women, aged 16~64 years, average age(41.3±11.7) years]. Of them, twentythree patients (7 men and 16 women) with average age of (55.4±7.8) years had received Chinese herbal medicines containing aristolochic acid. Of the 23 patients, 15 developed secondary cancer after kidney transplant, and the incidence was 65.2%. The mean duration of treatment with Chinese herbal medicines containing aristolochic acid was 2.75 (0.33~29) years. Two hundred and fiftysix patients (140 men and 116 women) with average age of (39.9±11.0) years had not received Chinese herbal medicines containing aristolochic acid. Of the 256 patients, 3 developed secondary cancer, and the incidence was 1.2%. The risk of developing secondary cancer in the patients who had received Chinese herbal medicines containing aristolochic acid was about 150 times greater than that in the patients who had not received Chinese herbal medicines containing aristolochic acid (RR: 158.125, 95% CI: 38.013~657.767, P=0.000). Conclusion: The patients who have received Chinese herbal medicines containing aristolochic acid may have an increased risk of developing secondary cancer after kidney transplant.
  • 学术研讨
    . 2006, 8(1): 8-12.
    传统的急救用药习惯和方法可引起许多不良反应,为了纠正这些问题,“2000心肺复苏指南”发表以来,根据循证医学的原则,对急危重症患者抢救的方法、技术、用药等进行了修订或改进。“2005心肺复苏指南”对上述问题又做出了进一步的建议。本文总结阐述了心肺复苏用药途径及常用药物使用的一些新的观念和理论,并在循证医学基础上就两个指南修改的原因进行解读,供医药同行参考。
  • 病例报告
    Chen Huiyun
    . 2007, 9(4): 255-261.
    A 21-year-old man with pneumonia was administered with IV azitromycin 0.5 g once daily.He developed persistence dull pain in the wrist and knee joint on day 2 after therapy.Physical examination showed every joint was normal.Laboratory tests revealed ASO and RF were also normal.Azithromycin was stopped and it was replaced with levofloxacin.Five days later,his arthralgia disappeared
  • Adverse Drug Reactions Journal. 2020, 22(3): 160-164. https://doi.org/10.3760/cma.j.cn114015-20200224-00162
    我国《新型冠状病毒肺炎诊疗方案(试行第六版)》推荐了8个品种的中药注射剂,包括喜炎平注射液、血必净注射液、热毒宁注射液、痰热清注射液、醒脑静注射液、参附注射液、生脉注射液和参麦注射液。8个中药注射剂主要适用于重型和危重型患者,其中喜炎平注射液适用于疫毒闭肺证患者,血必净注射液适用于瘀毒互结证和内闭外脱证患者,热毒宁注射液适用于疫毒闭肺证患者,痰热清注射液适用于痰热阻肺证患者,醒脑静注射液适用于热入营血,内陷心包证患者,参附注射液适用于内闭外脱证和阳气暴脱之厥脱证患者,生脉注射液适用于气阴两虚证和内闭外脱证患者,参麦注射液适用于气阴两虚证患者。中药注射剂最常见的不良反应为过敏反应,严重者可发生过敏性休克,应注意监测。
  • Guo Nan, Gao Ping, Jin Haobin, Sheng Jia, Shi Yaru, Bi Yunyan, Lyu Zhimei, Zhang Wen
    Adverse Drug Reactions Journal. 2023, 25(4): 197-203. https://doi.org/10.3760/cma.j.cn114015-20220923-00869
    To explore the characteristics and factors affecting the occurrence of renal injury in patients with abnormal biochemical indexes of renal function after the use of immune checkpoint inhibitors (ICIs), and to provide reference for selection of clinical treatment regimen. Methods Patients who were treated with immune checkpoint inhibitors researched and developed independently in China including camrelizumab, sintilimab, tislelizumab, and toripalimab from March 1, 2021 to February 28, 2022 and showed estimated glomerular filtration rate (eGFR) <90-ml/(min·1.73 m2) and/or serum creatinine (Scr)>105-μmol/L were retrieved from the China Hospital Pharmacovigilance System. The clinical data including general information, anti-tumor treatment regimen, laboratory test results, and concomitant medications were collected. Patients were divided into kidney injury group and non-kidney injury group, and all the clinical characteristics were compared between the 2 groups, the influencing factors of kidney injury were analyzed using a binary logistic regression model, the odds ratio (OR) and its 95% confidence interval (CI) were calculated. Results A total of 222 patients were entered in the analysis, including 170 males and 52 females, with a median age of 67 (36, 85) years. Of them, 144 patients were treated with carrilizumab, 38 with sindilizumab, 31 with tirelizumab, and 9 with treprolizumab; 29 patients (13.1%) developed kidney injury, including 26 cases of grade 1 and 3 cases of grade 2 renal injuries; the time of renal injury occurrence was 19-355 days after the first application of ICIs, and the median time was 108 days. After diagnosed of kidney injury, 13 out of 29 patients stopped ICIs, of which 6 had recovered kidney function and 7 had no improvement; 16 patients continued the ICIs treatment, of which 10 patients had recovered or improved kidney function and 6 had no improvement. The clinical characteristics of patients in the 2 groups were compared, and 10 variables including age, gender, baseline renal function, previous use of carboplatin, previous radiotherapy, combined chemotherapy containing cisplatin, combined paclitaxel chemotherapy, combined tyrosine kinase inhibitor (TKI) anti-vascular therapy, combined proton pump inhibitors, and combined radiotherapy were screened for the binary logistic regression analysis. The results showed that female (OR=3.046, 95%CI: 1.149-8.077), ≤65 years (OR=3.649, 95%CI: 1.435-9.274), combined TKI anti-vascular therapy (OR=4.773, 95%CI: 1.496-15.227), and combined radiotherapy (OR=8.655, 95%CI: 1.268-59.076) were independent risk factors for the development of kidney injury. Conclusions The incidence of kidney injury in patients with eGFR <90-ml/(min·1.73 m2) and/or Scr >105-μmol/L after using ICIs is 13.1%. In these patients, female, ≤65 years, combined TKI anti-vascular therapy, and combined radiotherapy may be risk factors for the development of ICI-associated kidney injury.
  • Cui Jiali, Niu Yurong, Liu Ning, Wang Huiyun, Song Shanai, Zhang Chuantao, Zhang Xiaochun, Hou Helei
    Adverse Drug Reactions Journal. 2023, 25(11): 641-648. https://doi.org/10.3760/cma.j.cn114015-20230601-00388
    Objective To explore the clinical manifestation, treatments, and outcomes of immune checkpoint inhibitor (ICI)-induced immune-mediated liver injury (IMLI). Methods The patients with ICI- related IMLI and hospitalized in the Department of Oncology, the Affiliated Hospital of Qingdao University from January 2018 to November 2022 were collected. The basic information, tumor treatments, clinical manifestation, treatments and outcomes of the patients with IMLI were retrospectively analyzed. Results A total of 29 patients were included in the study, including 17 males (58.6%) and 12 females (41.4%), with a median age of 65 years. The median treatment cycle from the use of ICI to the occurrence of liver injury was 3 cycles, and the median time was 78 days. In patients with IMLI, 48.3% (14/29) had no obvious symptoms and 51.7% (15/29) had symptoms such as decreased appetite, nausea, abdominal distension, fatigue, fever and jaundice; 44.8% (13/29) were accompanied by other immune-related adverse events. The clinical classification of IMLI was hepatocellular type in 18 patients (62.1%), cholestasis type in 4 patients (13.8%), and mixed type in 7 patients (24.1%). According to the Common Terminology Criteria for Adverse Events (CTCAE) classification, severe liver injury (≥ grade 3) accounted for 86.2% (25/29), while according to the Chinese Diagnosis and Treatment Guideline on Drug-Induced Liver Injury (DILI guidelines) classification, severe liver injury (≥ grade 2) accounted for 34.5% (10/29). All 29 patients discontinued the treatment of ICIs after occurrence of IMLI, and 28 patients were treated with glucocorticoids, 7 of which were combined with mycophenolate mofetil and/or human immunoglobulin and artificial liver; 22 patients (75.9%) were improved. In the other 7 patients that did not recover, 4 discharged automatically, 2 died, and 1 could not be judged. ICI was rechallenged in 3 patients after liver function improvement, and IMLI did not recur. Conclusions The IMLIs often occur 2 to 3 months after the start of ICI treatment, the most common clinical type is hepatocyte type, and the severity of clinical symptoms in patients vary from mild to severe. After discontinuing ICIs and receiving glucocorticoid treatments, most patients may have a good prognosis.
  • 病例报告
    Pang Fujia
    . 2007, 9(5): 364-364.
    A 31-year-old man was treated with norfloxacin 0.4 g by intravenous infusion for acute gastmenteritis.After 40 minutes of infusion,he developed an insensible feeling on his left face.Followed by paroxysmal electric shock-like megalgia lasting about 10 seconds every times and the pain attacks occurred every 5 minutes approximately.The infusion was stopped immediately and the patient was given symptomatic and supportive therapy.The next day,norfloxacin was replaced with amikacin.The frequency and severity of pain attacks were reduced.After 3 days of therapy,his trigeminal neuralgia-like pain disappeared completely.
  • 调查研究
    Qi Xiaolian①;Xin Yanli②;Chen Lianzhen①;Wang Yuqip①
    . 2005, 7(4): 256-259.
    Objective:To evaluate the safety of clindamycin injection for prevention of postopevative infection. Methods: By way of questionnaire and interview, the patients receiving clindamycin injection for prevention of postoperative infection were investigated and analysed. Results: 98 inpatients were involved in the study of clindamycin for prevention of postoperative infection, 51 cases of them used clindamycin alone(infection control rate 100%), and 47 cases of them used clidamycin in combination with other drugs, 7 cases occurred adverse drug reactions, mainly nausea, vomiting, diarrhea, granulocytopenia and increased transaminases. Conclusion: Clindamycin can prevent the postoperative infections when used alone and in regular doses.
  • 临床论著
    Jiang Beiqi;Li Zhengdong;Zhuang Zhigang
    . 2009, 11(3): 165-5.
    Objective: To observe docetaxel-related adverse reactions to TAC regimen (docetaxel plus epirubicin and cyclophosphamide) and AC-T regimen (epirubicin plus cyclophosphamide followed by docetaxel) in treatment of breast cancer in order to evaluate their clinical safety. Methods: From July 2004 to June 2008, 110 patients with confirmed breast cancer were enrolled in the study and divided into two groups: the TAC regimen group and the AC-T regimen group. The TAC regimen group comprised 72 patients; patient age ranged from 28 to 55 years [average age (45±7.2) years]. The AC-T regimen group comprised 38 patients; patient age ranged from 35 to 66 years [average age (48±6.4) years]. The patients in the TAC regimen group received an IV push of epirubicin 60 mg/m2, an IV push of cyclophosphamide 500 mg/m2, and an IV infusion of docetaxel 75 mg/m2 on day 1 of every 21-day cycle for 6 cycles. The patients in the AC-T regimen group received an IV push of epirubicin 75 mg/m2 and an IV push of cyclophosphamide 500 mg/m2 on day 1 of every 21-day cycle for 4 cycles, followed by an IV infusion of docetaxel 75mg/m2 on day 1 of every 21day cycle for 4 cycles. Docetaxelrelated adverse reactions were observed during treatment with the two regimens. Results:Neutropenia in the TAC regimen and AC-T regimen groups was 72 cases (100%) [64 cases (88.9%) of grade 3/4 neutropenia] and 32 cases (84.2%) [16 cases (42.1%) of grade 3/4 neutropenia], respectively; granulocytic fever was 62 cases (86.1%) and 6 cases (15.8%), respectively. The differences in grade 3/4 neutropenia and granulocytic fever between the TAC regimen and AC-T regimen groups were statistically significant (all P<0.01). Anaphylaxis was 10 cases (13.9%) and 5 cases (13.2%), respectively; watersodium retention was 3 cases (4.17%) and one case (2.63%), respectively; peripheral neurotoxicity was 33 cases (45.8%) and 12 cases (31.6%), respectively; changes in skin and nail were 28 cases (38.9%) and 13 cases (34.2%), respectively. There were no significant differences in incidence of anaphylaxis, water-sodium retention, peripheral neurotoxicity, and changes in skin and nail between the TAC regimen and AC-T regimen groups (all P>0.05). Conclusion: AC-T regimen is a relatively safe chemotherapy regimen.
  • 综述
    . 2006, 8(3): 161-165.
    阿尔茨海默病是一种退行性脑病。目前药物治疗手段包括补充胆碱能神经递质、抑制β-淀粉样肽沉积、抗氧化、雌激素治疗、抗炎治疗、调节钙平衡、调节谷氨酸能神经传递系统功能、抑制tau蛋白过度磷酸化及传统中医药治疗等。随着人们对其发病机制的了解,其治疗策略日益增多,临床前景广阔,成为科学家的研究热点。
  • 安全用药
    . 2002, 4(5): 306-308.
    通过检索文献中辛伐他汀的不良反应病例报告,了解其不良反应及安全应用。辛伐他汀的主要不良反应有肌病,并伴有肌酸磷酸激酶(CPK)升高,ALT升高及肾功能损害等,且不良反应与剂量相关。选择合适人群、剂量,用药期间注意监测CPK 及肝、肾功能,可安全有效地应用于临床。
  • 病例报告
    Bi Jinlian
    . 2007, 9(5): 368-368.
    A 56-year-old female patient was hospitalized with vomiting of unknown reason for more than a month.A laboratory test revealed her cortisol level of 58.0 nmol/L at 8:00 AM.The patient Was diagnosed as having hypoadrenocorticism.She was glven IV hydrocortisone 100 mg daily.Three days later,the patient developed manic-state which manifested excitement,delirium,and uncon-、 tmllable behaviors.Hydroeortisone was withdrawn immediately.After one day of symptomatic therapy,the patient regained normal sta- tus.
  • 论著
    Bai Yurong①;Hu Taohong①;Pei Yu②;Tong Weihang③
    . 2007, 9(6): 381-383.
    Objective:To observe the changes in urine glucose and blood glucose induced by puerarin injection in patients with hypertension.Methods:Nineteen in-patients with hypertension [11 male,8 female,average age(71.11±3.54) years] were administered with intravenous infusion of puerarin 500 mg dissolved in 250 ml of sodium chloride injection 0.9%.The urine glucose and blood glucose levels were measured 1 hour,5 hours,11 hours,and 21 hours(the next day,fasting) after the start of administration and at the same time as mentioned above in the next day(discontinuation of puerarin).Results:The positive rates of urine glucose were 15.8%,84.2%,and 36.8% respectively 1 hour,5 hours,and 11 hours after the start of administration,and 0,5.26%,and 5.26% respectively at the same time as mentioned above in the next day.The positive rates in the former were higher than those in the latter.The deferences were statistically significant(P<0.05,P<0.01,P<0.05).The urine glucose test was negative 21 hours after the start of administration.There were no statistical differences between the former and the latter in blood glucose levels(P>0.05).Conclusion:Puerarin injection may cause positive urine glucose in patients with hypertension,which rapidly becomes negative after the cessation of the drug.Puerarin injection has no effects on blood glucose.
  • 临床论著
    Zhang Yanfang;Hu Yuhong
    . 2010, 12(3): 157-3.
    Objective: To evaluate the efficacy and safety of telbivudine in preventing mothertoinfant HBV transmission in HBVinfected pregnant women during the last trimester of pregnancy. Methods:A total of 120 pregnant women, who had positive HBsAg and HBeAg with a HBV DNA level of ≥1×106 copies/mL,were divided into two groups: the telbivudine group aged 2336 years and the control group aged 24-37 years. Each group comprised 60 cases. The subjects in the telbivudine group received telbivudine 600 mg once daily from 28 weeks of pregnancy till 1 month after delivery. The subjects in the control group did not receive telbivudine. The serum HBV DNA levels in the two groups were measured at 28 weeks of pregnancy, upon delivery and 6 months after delivery, respectively. The adverse reactions to subjects in the telbivudine group were observed. The infants in the two groups received IM HBIG 200 U immediately after birth and 1 month after birth, and IM hepatitis B vaccine 10 μg immediately after birth as well as 1 month and 6 months after birth, respectively. The serum HBsAg and HBV DNA levels in all infants were measured 24 hours, 6 months, and 1 year after birth, respectively. Results:There was no significant difference in serum HBV DNA levels between the telbivudine group[(6.62±0.90)×106 copies/mL] and the control group[(7.22±1.27) ×106 copies/mL] at 28 weeks of pregnancy. The serum HBV DNA level in the telbivudine group[(0.49±0.54) ×103 copies/mL] was significantly decreased compared with the control group[(7.46±1.06) ×106 copies/mL] immediately after delivery(P<0.05). There was no significant difference in HBV DNA levels between the telbivudine group[(6.23±0.85) ×106 copies/mL] and the control group[(7.55±1.88) ×106 copies/mL] 6 months after delivery. Thirteen subjects in the telbivudine group had a mild elevation in creatine kinase during 2836 weeks of pregnancy. Telbivudine was stopped. Two weeks later,the creatine kinase levels in the subjects mentioned above returned to normal range. The number of 6monthold infants, who were positive for HBsAg and HBV DNA, was significantly lower in the telbivudine group (1 case) than that in the control group (11 cases) (P<0.05). The rate of mothertoinfant HBV transmission in 12monthold infants in the telbivudin group and the control group were 98.3% and 81.7%, respectively. The difference was statistically significant (P<0.05). Abnormal development was not found in the infants in the two groups. Conclusion:Telbivudine appears to be effective and safe in preventing HBV mothertoinfant transmission and has no influence on infant development.
  • 中药不良反应
    Ma Huizhen;Guo Meizi;Zhang Wei
    . 2007, 9(4): 291-292.
    A 77-year-old man with primary hypertension was administered with losartan potassium 50 mg once daily for a prolonged treatment.Xuezhikang tablets 0.6 g twice daily were added to his regimen for increased blood lipids.After 56 days of administration of Xuezhikang tablets,the patient developed dark urine,yellowing of skin,and mild hypodynamia.Laboratory tests revealed the following values:ALT 1 017 U/L,AST 511 U/L,AKP 312 U/L,γ-GT 236 U/L,Tbil 91.2 μmol/L,Dbil 63 μmol/L,Alb 39.2 g/L,cholinesterase 6.6 U/L,LDH 244 U/L,BUN 7.4 mmol/L,Cr 101 μmol/L,urobilinogen(+),urobilirubin(+++).After withdrawal of Xuezhikang tablets and liver protective treatment with silybin meglumine,reduced glutathione,and alprostadil injection for about one month,his liver function returned to normal.
  • 药物评介
    . 2007, 9(2): 146-149.
    雷洛昔芬是第二代选择性雌激素受体调节剂,在骨组织中具有雌激素样作用,在乳腺组织和子宫内膜中则有抗雌激素样作用,可用于治疗绝经后妇女骨质疏松症,临床研究发现它还有预防浸润性乳腺癌(invasive breast cancer)的作用。其常见的不良反应主要有流感样症状、潮热、小腿痉挛、外周水肿、宫腔积液及胆囊疾病等,严重的不良反应有静脉血栓栓塞和致死性卒中,不同研究报道的不良反应发生率不完全相同。长期使用雷洛昔芬治疗对冠心病患者的突发事件危险无显著影响,也不会增加患子宫内膜癌的风险。雷洛昔芬降低临床椎骨骨折(clinical vertebral fractrue)和浸润性乳腺癌的风险与增加静脉血栓栓塞和致死性卒中的风险相当,临床医师在选用该药时应权衡利弊综合考虑。
  • 论著
    Lin Na;Li Tianzuo
    . 2011, 13(2): 69-4.
    Objective: To summarize the effectiveness and safety of general anesthesia with sevoflurane inhalation during phacoemulsification and intraocular lens implantation for cataracts in children. Methods: The clinical data from 145 children (84 boys and 61 girls, aged 3 to 8 years, ASA physical statusⅠorⅡ) who underwent the phacoemulsification and intraocular lens implantation under general anesthesia with sevoflurane inhalation in Beijing Tongren Hospital during the period from May 2009 to August 2010 were collected and analyzed, retrospectively. Anesthetic induction was performed with 8% sevoflurane and oxygen (5 L/min) via a face mask. The venipuncture was performed after the children became unconscious, and a laryngeal mask airway (LMA) was inserted when the bispectral index scale (BIS) was <60 and the lower jaw relaxed. Anesthetic maintenance was performed with 3% 4% sevoflurane and oxygen (2 L/min) via a LMA and the spontaneous respiration was maintained, the artificial ventilation was performed intermittently during the operation. The BIS value, heart rate (HR) and respiratory rate (RR) were recorded before anesthetic induction (T1), at the time point of the lowest BIS after being unconscious (T2), before insertion of a LMA (T3), and during anesthetic maintenance (T4), respectively. The adverse reactions, such as cough, breath holding, laryngospasm, vomiting, increased secretions and hypoxemia were monitored during the induction and maintenance of anesthesia. Results: Before anesthetic induction, the children’s BIS value was 9498 (98±2) and the HR was (111±10)beats/min. Unconsciousness appeared 1534 (20±3)s after inhalation of 8% sevoflurane, meanwhile the BIS value decreased to 1238 (23±7), the HR increased to (160±12) beats/min, and the maximum HR was 180 beats/min. In comparison with the BIS value and HR before anesthetic induction, the differences were statistically significant (all P<0.01). At the lowest BIS value, jerking movements occurred in the limbs and the body in 73.1% cases (106/145) lasting for 510 s and then disappeared. When BIS value increased to 2442 (35±4) and the children’s lower jaws relaxed, the LMA could be inserted smoothly. The differences in HR was statistically significant (P<0.01) between T3 [(97±10)beats/min] and T1[(111±10)beats/min]. The differences in average RR among the duration of anesthetic induction[(21.6±34)/min], the duration of anesthetic maintenance[(29.0±3.8)breath/min], and before the anesthetic induction[(24.6±3.6)breath/min] were statistically significant (all P<0.01). There were no breath holding, laryngospasm, cough, increased secretions, vomiting, hypoxemia and other severe adverse reactions in 145 children during anesthesia and their operations were completed uneventfully. Conclusion: The general anesthesia with sevoflurane inhalation is effective and safe during cataract surgery in children but, during anesthetic induction, they should be carefully monitored in order to avoid the accident injury due to jerking movements of the limbs and the body.
  • Wang Yanning, Zhou Yujie, Miao Liyun
    Adverse Drug Reactions Journal. 2020, 22(7): 404-408. https://doi.org/10.3760/cma.j.cn114015-20190916-00769
    Pulmonary arterial hypertension (PAH) is a rare but extremely serious adverse reaction of interferon (IFN). The onset of PAH in patients treated with IFNα was earlier than that in patients treated with IFNβ. The symptoms in most patients could be alleviated or recovered after discontinuing IFN and/or receiving PAH-targeted drug therapy, but a few patients might develop irreversible PAH, which even led to death. Possible risk factors for IFN-associated PAH included portal hypertension, human immunodeficiency virus infection, connective tissue diseases, valvular heart diseases, diabetes mellitus, and etc. The patho- genesis of IFN-associated PAH remains unclear at present. Patients treated with IFN should be examined by echocardiography and right heart catheterization as soon as they have symptoms such as dyspnea and impaired exercise tolerance. After the diagnosis of PAH, IFN should be discontinued immediately and PAH-targeted drug therapy should be given.
  • Gao Lei, Li Man, Cai Jun, Cui Wenxia, Hu Yun
    Adverse Drug Reactions Journal. 2020, 22(11): 656-657. https://doi.org/10.3760/cma.j.cn114015-20200119-00054
    A 77-year-old female patient received an intravenous infusion of zoledronic acid injection 5-mg for osteoporosis. The patient had a history of asthma and no asthma attacks before medication. Nineteen hours after the intravenous infusion of zoledronic acid injection, the patient developed asthma, dyspnea, and wheezing in both lungs. Bronchial asthma attack was diagnosed, which was considered to be induced by zoledronic acid injection. An IV infusion of methylprednisolone, venous pumping of doxofylline, and aerosol inhalation of salbutamol, ipratropium bromide, and budesonide for inhalation were given immediately. Thirty minutes later, her symptoms of asthma and dyspnea were relieved. Twenty-six hours later, bronchial asthma recurred and was improved again after the above treatments. However, the patient′s exercise tolerance decreased. After 3 months of treatments with inhalation of budesonide and formoterol fumarate powder for inhalation and oral administration of montelukast, her exercise tolerance returned as before zoledronic acid injection.
  • Sun Libo, Song Yanqing, Hu Xue, Li Yanjiao
    Adverse Drug Reactions Journal. 2021, 23(1): 25-29. https://doi.org/10.3760/cma.j.cn114015-20200728-00815
    Objective To analyze the clinical characteristics of novel oral anticoagulants (NOAC)-related leukocytoclastic vasculitis (LCV). Methods PubMed, Embase, ScienceDirect, Ovid, and Scopus databases were searched as of August 2020 and case reports on NOAC-related LCV were collected. Relevant information in patients including gender, age, primary disease, co-existing disease, NOAC application, combined medication, LCV occurrence, treatment and outcome of LCV, and etc. was extracted and analyzed using descriptive statistical method. Results A total of 13 patients were collected; 6 were from the United States, 2 from Turkey, 2 from Spain, and 3 from Greece, South Korea, and Denmark, respectively. There were 8 males and 5 females, aged 29 to 95 years, and 9 patients were ≥60 years old.   Apixaban was applied in 5 patients, rivaroxaban in 5 patients, and dabigatran etexilate in 3 patients. Dose of NOAC was recorded in 7 patients, all of which were within the recommended range of the instructions. Time from taking NOAC to the occurrence of LCV was recorded in 12 patients, ranging from 3-18 days (7-10 days in 7 patients) after the first medication. All 13 patients developed skin lesions, presenting as purpura and/or rash. Skin lesions involved limbs and trunk in 4 patients, lower limbs in 7 patients, lower limbs and trunk in 1 patient, and upper limbs and trunk in 1 patient. Twelve patients underwent skin biopsy at the lesion site; 11 patients had neutrophil infiltration and 1 had only eosinophil infiltration. NOAC was stopped in all the 13 patients after diagnosis of LCV. Among them, other anticoagulants were switched in 12 patients and glucocorticoids were given in 9 patients. Finally, 8 were cured and 5 were improved. Conclusions NOAC-related LCV usually occurred 7-10 days after the first medication, mainly manifested as purpura and rash and often involved the lower extremities. The prognosis was good after drug withdrawal and appropriate application of glucocorticoid according to patient conditions.
  • Song Haiyan, Zhang Hongyan, Sun Shiguang
    . 2016, 18(6): 439.
    ObjectiveTo evaluate the rationality of clinically using Shengmai injection in inpatients extracted and explore the related factors.MethodsMedical records of patients who were hospitalized in the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from January to December in 2015 and treated with Shengmai injection were extracted through hospital information system. Twenty medical records in each month were selected randomly. The rationality of Shengmai injection treatments were evaluated according to 8 items in drug information leaflets (diagnosis of diseases in western medicine, diagnosis of diseases in traditional Chinese medicine, dosage, solvents, volume of solvents, drug concentration, administration frequency, and incompatibility; scored as 1 or 0 for each parameter) and drug utilization index (DUI, DUI=1.0 means the drug usage was rational, otherwise was irrational). The patients who developed adverse events were matched with those who did not develope adverse events with ratio of 1 ∶  4 and correlation between the above-mentioned 8 items and the occurence of adverse events were analyzed using multivariate conditional logistic regression model.ResultsA total of 240 records were collected, including 240 patients. Of them, 116 patients were males and 124 were females with age from 44 to 78 years, their average age was (59±13) years. All 240 patients had diagnosis of western medicine and 206(85.8%) patients had diagnosis of traditional Chinese medicine. The total rate of drug use rationality of 8 items in drug information leaflets was 59.7% (1 147/1 920); 2 items of them, administration frequency and incompatibility were 100%; the rates of drug use rationality of other 6 items were  drug concentration 62.1%(149/240), drug dosage 57.5% (138/240), solvents 48.3% (116/240), diagnosis of disease of western medicine 42.9% (103/240), volume of solvents 38.8% (93/240), and diagnosis of diseases of traditional Chinese medicine 28.3% (68/240). DUI of Shengmai injection in patients in our hospital during 2015 was 1.23-1.69 and the average DUI was 1.62±0.21. Seven adverse events related to Shengmai injection occured in 7 patients (dyspnea in 3 patients, rash in 2 patients, itching in 1 patient, and shivering in 1 patient). All these adverse events were induced by irrational drug use. Multivariate conditional logistic regression analysis showed that the occurence of adverse events were related to diagnosis of diseases of traditional Chinese medicine (OR=0.617, 95%CI: 0.491-0.810, P<0.05) and drug concentration (OR=0.533, 95%CI: 0.385-0.733, P<0.05).ConclusionsIrrational use of Shengmai injection in clinics existed, mainly in off label drug use, overdose, and improper solvents. The occurence of adverse events was related to diagnosis of diseases of traditional Chinese medicine and drug concentration.
  • 安全用药
    . 2003, 5(6): 388-389.
    曲妥珠单抗是第一个用于治疗人表皮生长因子受体2(HER2)阳性转移性乳腺癌的人源化的单克隆抗体药物,临床上主要用于治疗HER2阳性的转移性乳腺癌,疗效确切,毒副作用轻微,耐受性好。其常见的不良反应主要是发热反应、心功能障碍等,本文对其不良反应的预防及处理方法作一介绍。
  • 调查研究
    Gao Wenbin①;Yu Keda②;Wang Lishuang②;Wang Lei②;Ying Liangwei②
    . 2005, 7(1): 15-17.
    Objective: To observe cardiotoxicity and safety of high-dose epirubicin by continuous intravenous infusion. Methods: 147 women with no existing heart problems received chemotherapy after breast cancer resection. They were treated with epirubicin in combination with other antineoplastics-24-hour continuous intravenous infusion of high-dose epirubicin for observation group (80 mg per m2 body-surface)and intravenous injection of its low-dose for control group (40 mg per m2 body-surface)-once every 3 weeks as a course for 6 consecutive courses. Cardiac function was carefully monitored with electrocardiography and contrast echocardiography before and after treatment at the end of the second-fourth-sixth courses and the third and sixth months. Results: Cardiotoxicity didn't occure until at the end of the fourth course. Its incidence was increased with time-more in observation group than in control group but with no statistical difference between them. Conclusion: High-dose epirubicin administered by continuous intravenous infusion is safe and the resultant cardiotoxicity is much the same as one caused by usual doses of the drug. Patients showed tolerance to epirubicin.
  • 病例报告
    Zhang Jie
    . 2009, 11(2): 142-1.
    A 57yearold man with posthepatitic cirrhosis received an IV infusion of cefmetazole sodium 2 g dissolved in 100 ml of glucose 5% for a peritoneal infection. About 5 minutes after infusion completion, he abruptly developed chill and chest distress. On examination, he had a pulse rate of 130 beats/min, a respiratory rate of 24 breaths/min, a BP of 130/70 mm Hg, a blood oxygen saturation of 0.95, and an increase in breath sound in his lungs. Oxygen inhalation therapy, IV dexamethasone 2 mg and IV calcium gluconate 10% were given immediately. Forty minutes later, his symptoms were relieved. Two hours and a half later, his pulse rate was 96 beats/min, his respiratory rate was 22 breaths/min, and his BP was 110/70 mm Hg. A review of his medical history revealed that he had received cefmetazole sodium 2 g twice daily for 15 days one month earlier and no adverse reaction was found.
  • 中药不良反应
    Han Feng;Shi Bei;Jian Lingyan*
    . 2008, 10(3): 220-1.

    A 40yearold woman with type Ⅱ diabetes was administered with 100 ml of IV saffloryellow sodium chloride injection for treatment of numbness of hand and foot. After about one minute of infusion, the woman experienced severe abdominal pain, facial flushing, dyspnea, skin eruption on her neck and a BP of 60/40 mmHg. The intravenous infusion was discontinued at once. Her symptoms markedly improved thirty minutes after symptomatic treatment; her BP was 100/70 mmHg and her skin eruption resolved gradually. The following day, her condition was stable.

  • 病例报告
    Li Qizhi;Yang Xiaowei;Yan Zhijun;Zhang Dongsheng;Jiang Zaihui
    . 2009, 11(6): 396-1.
    A 90yearold man received an IV infusion of levofloxacin 0.3 g twice daily and then an IV infusion of adenosine triphosphate 20 mg, coenzyme A 100 U, and 7 ml of sodium chloride 10% dissolved in 250 ml of glucose 5% once daily for pneumonia complicated by cephalic shingles. The second day, the patient developed sleeplessness, auditory hallucination, visual hallucination, and thought incoherence. Neurological examination did not show positive signs. Levofloxacin was stopped and switched to azithromycin. One day later, his mental symptoms disappeared.
  • 安全用药
    . 2004, 6(4): 246-248.
    阿莫西林/克拉维酸钾抗菌谱广且副作用较少,但近年也有一些少见的严重不良反应报告,包括肝毒性反应、消化性溃疡、出血性肠炎、粒细胞减少、多形性红斑、药物热等。本文对此加以综合介绍,以引起临床注意。
  • Li Chen, Su Haibin, Hu Jinhua, Shi Chenhui
    Adverse Drug Reactions Journal. 2022, 24(9): 502-504. https://doi.org/10.3760/cma.j.cn114015-20220119-00058
    A 37-year-old female patient took orlistat capsules 120-mg thrice daily orally for weight loss. Four weeks later, she developed fatigue, poor appetite, and nausea; 6 weeks later, jaundice and decreased urine volume occurred and laboratory tests showed alanine aminotransferase (ALT) 7-631-U/L, aspartate aminotransferase (AST) 6-295-U/L, total bilirubin (TBil) 46.0-μmol/L, serum creatinine (Scr) 266-μmol/L, and international normalized ratio (INR) 1.73. Acute liver and kidney injury caused by orlistat capsules was considered. Then orlistat was discontinued, and symptomatic and supportive treatments such as liver protection, enzyme lowering, fluid replacement, and renal perfusion improvement were given. Ten days later, the symptoms above-mentioned in the patient were improved obviously, and laboratory tests showed ALT 181-U/L, AST 25-U/L, TBil 9.8-μmol/L, Scr 121-μmol/L, and INR 0.9. The liver and renal function in the patient was normal both at 3 months and 1 year of follow-up.
  • Ren Hao, Zhu Jianfu, Qiu Haitang
    Adverse Drug Reactions Journal. 2022, 24(4): 175-184. https://doi.org/10.3760/cma.j.cn114015-20210927-01023
    Objective To explore the efficacy and safety of aripiprazole in the treatment of antipsychotic-induced hyperprolactinemia (AIH). Methods Randomized controlled trials (RCTs) of aripiprazole in treating AIH were collected by searching relevant databases at home and abroad (up to November 29, 2020). Patients in the trial group was treated with aripiprazole on the base antipsychotic drugs, and those in the control group was treated with or without additional placebo. Outcome indicators included serum prolactin normalization rate, serum prolactin level, and the incidence of major adverse events. Meta-analysis was performed using RevMan 5.4-software. The effect size of counting data was risk ratio (RR) and its 95% confidence interval (CI), and the effect size of measurement data was standardized mean difference (SMD) and its 95%CI. Results A total of 23 RCTs were entered in the analysis, including 1-530 patients, 816 patients in the trial group and 714 patients in the control group. The meta-analysis results showed that the normalization rate of serum prolactin in the trial group was higher than that in the control group at the end of the treatment course (4-24 weeks) [73.5% (150/204) vs. 4.1% (8/194), RR=16.58, 95%CI: 8.61-31.93, P<0.001]. According to the dose of aripiprazole, the patients were divided into 5-mg/d and 10-mg/d subgroups. The analysis results showed that the serum prolactin levels in patients in the 2 trial subgroups were lower than those in their corresponding control groups at the end of the treatment, and the differences were statistically significant [SMD=-1.25, 95%CI: -1.66--0.84,P<0.001; SMD=1.93, 95%CI: -2.38--1.48, P<0.001]. There were no significant differences in the incidence of overall adverse events, extrapyramidal reactions, insomnia, somnolence, and weight gain in patients between the trial and control groups during the trial [26.5% (103/388) vs. 24.1% (94/390), RR=1.10, 95%CI: 0.90-1.36, P=0.35; 26.0% (53/204) vs. 34.0% (70/206), RR=0.77, 95%CI: 0.58-1.02, P=0.06; 8.4% (31/368) vs. 9.9% (37/372), RR=0.86, 95%CI: 0.56-1.33, P=0.50; 5.6% (19/340) vs. 4.7% (16/342), RR=1.16, 95%CI: 0.64-2.12, P=0.63; 0 vs. 7.9% (7/89), RR=0.18, 95%CI: 0.03-0.99), P=0.05]. Conclusion Aripiprazole is safe and effective in the treatment of AIH, but the long-term efficacy and safety need to be explored.
  • Yan Jingjing, Han Yi, Fan Manli
    Adverse Drug Reactions Journal. 2021, 23(6): 319-321. https://doi.org/10.3760/cma.j.cn114015-20201202-01196
    A 44-year-old male patient was hospitalized twice for chronic hepatitis B and alcoholic cirrhosis with hepatic encephalopathy. During the 2 times of hospitalization, the patient was treated with reduced glutathione and ornithine aspartate and developed bilateral submandibular gland enlargement on the 2nd day after the first medication in each hospitalization. Physical examination showed no abnormal skin color and temperature, no obvious tenderness, intact oral mucosa, and no redness and swelling of submandibular gland duct orifice. Ultrasonic examination showed diffuse enlargement of bilateral submandibular gland and visible peripheral lymph nodes and bilateral cervical lymph nodes. It was never aware to be drug-related in the first occurrence of submandibular gland enlargement, therefore the drug was not stopped and no special treatment was given. The patient′s submandibular gland enlargement subsided spontaneously 2 days later. During the 2nd hospitalization, the patient developed bilateral submandibular gland enlargement again, which was considered to be related to reduced glutathione because no submandibular gland enlargement appeared in the patient during the repeated use of ornithine aspartate in the past. Then the reduced glutathione was stopped and ornithine aspartate was continued. The patient′s submandibular gland enlargement subsided completely 1 day later.
  • Wu Guiying, Wuriliga, Li Hongbin, Tie Ning, Bai Lijie, Wang Yong
    Adverse Drug Reactions Journal. 2023, 25(9): 574-576. https://doi.org/10.3760/cma.j.cn114015-20221008-00922
    A 34-year-old male patient received a subcutaneous injection of 300 mg of secukinumab once a week for 5 times, subsequently 300-mg once every 4 weeks for 3 times because of psoriasis. Then the patient developed bloody purulent stool. Electronic colonoscopy revealed diffuse mucosal congestion and edema in the sigmoid colon at a distance of 25 cm from the anus. The pathological examination results of tissue biopsy showed severe chronic inflammation, erosion, and shallow ulcer formationin the sigmoid colon. Inflammatory bowel disease caused by secukinumab was considered. Then the drug was stopped, and mesalazine enema solution 60 g once daily was given. After half a month of treatment, the patient′s bloody purulent stool was improved significantly, and after 2 months, it disappeared. Electronic colonoscopy showed that the mucosa of the sigmoid colon was rough, granular, and scattered with small patches of bleeding at a distance of 20-cm to 25-cm from the anus, which was diagnosed as having ulcerative colitis (in remission). Mesalazine enema was discontinued and changed to mesalazine suppository 0.5 g once daily.
  • 安全用药
    Jia Dongganga;Zhao Wanzhenb Lei Zhaobao
    . 2010, 12(1): 37-5.
    Amoxicillin-clavulanate potassium is a widely used antibiotic and its antimicrobial spectrum is the same as that of amoxicillin. Hepatitis and cholestatic jaundice related to amoxicillinclavulanate potassium have been reported. The mechanism is unclear, however, it may involve in immune reactions or metabolism factors. The incidence is about 0.001%~0.022%. The time to hepatotoxic reaction onset is several days or weeks( average 8.9 days) after treatment start. Clinical manifestations include jaundice, itching, weakness, nausea, vomiting, hepatomegaly, skin rash, abdominal pain, fever, and so on. The serum ALT, AST, alkaline phosphatase, and γ-GT levels markedly increase ( 2~10 times the upper limit of normal). Generally, jaundice subsided within 1 to 8 weeks after the drug discontinuation and liver functions return to within normal range 4 to 16 weeks after the drug stop. The risk factors for hepatotoxic reactions include male (the ratio of males to females is about 4 to 1 or 2 to 1 ), advanced age, long-term treatment, and combination therapy ( especially hepatotoxic drugs such as acetaminophen, allopurinol, and erythromycin ). Preventive measures are as follows: never use amoxicillin-clavulanate potassium unless there is a good indication; the drug should be avoided or used very carefully in male aged > 65 years; the treatment duration should not exceed 14 days; multidrug therapy should be avoided; monitoring should be performed during treatment. -
  • Cheng Honga;Wu Shuyunb
    Adverse Drug Reactions Journal. 2009, 11(4): 298-1.
    A 37-year-old man received Zhixue capsules (dosage not stated). About two weeks later, the patient presented with asthenia, anorexia, dark urine, yellowish skin and sclera. Liver function tests revealed the following levels: ALT 2966 U/L,AST 1865 U/L,TBil 96.7 μmol/L,DBil 56.9 μmol/L. On day four after admission, liver function tests showed the following values: ALT 946.9 U/L,AST 164.7 U/L,TBil 200.9 μmol/L,DBil 130.1 μmol/L;PT 20.4 s,PTA 30.9%,and INR 1.65. After 10 days of symptomatic treatment, his symptoms improved. One month after hospitalization, his ALT was 36 U/L, his AST was 20.4 U/L, his TBil was 29.2 μmol/L,his DBil was 17.0 μmol/L, and his prothrombine time and eosinophilic granulocyte count normalized.
  • 综述
    . 1999, 1(1): 8-13.
    全世界有1亿多妇女使用OC。对于绝大多数使用者来说OC产生的效益远大于危险性。1960年OC上市后很快出现不良反应报告。嗣后开展OC与心血管疾病与癌症等风险关系的流行病和临床研究。本文主要介绍这些研究的结论性意见。已证实OC使用者静脉血栓症风险增加,与心肌梗死的关系意见不一致。含高剂量雌激素复方制剂可增加心肌梗死发生风险,尤其伴有吸烟等心血管疾病危险因素的妇女更易出现。脑血管疾病的危险性不大。OC与癌症的因果关系无可靠证据。虽然有不少研究探讨这个问题,其结果仍不一致。一些病例对照研究证实OC可减少子宫内膜癌和卵巢上皮癌的发生风险。虽然OC的绝对危险性很低,仍然须要强调在我国700多万使用者中开展OC不良反应市场后监察以及效益与风险的流行病学评价的必要性。
  • 论著
    Fan Shuangyi①;Chen Xiaowei②;Fan Hongxiao②;Zhang Chunqing②;Wu Yi②;Xue Li②;Hu Zhian②
    . 2006, 8(2): 101-104.
    Objective: To investigate the effects of borneol in the treatment of impaired awake activity and cognitive function induced by long-term continuous operations. Methods: A rat model of long-term continuous operations was first established by using a treadmill protocol. All of the rats were divided into three groups: vehicle-treated operational group, borneol-treated operational group and non-operational group. Subsequently, locomotor activity, wakefulness time and active avoidance response of rats during the subjective day were observed after application of borneol. Results: There were 6 rats fortest in each of the thres group. The results showed that borneol at the dose of 0.4 g/kg had a prominent stimulated effect on spontaneous locomotive activity (non-opreational group 54.1 ±5.4 times/min, vehicle-treated operational group 15.5±8.3 times/min, borneol-treated operational group 26.8±7.8 times/min; n=6, P<0.05) and wake-fulness time (non-operational group 639±46 min, vehicle-treated operational group 411±36 min, borneol-treated operational group 501±52 min, P<0.05). Moreover, borneol showed an improved action on the cognitive function of rats (non-operational group 5.63±1.01 s, vehicle-treated operational group 6.85 ±1.24 s, borneol-treated operational group 6.26±0.96 s; P<0.05) after long- term continuous operations. Conclusion: Borneol appears to have a potential function in the treatment of impaired awake activity anddepressed cognitive function caused by long-term continuous operations.
  • 调查研究
    Chen Yan;Jin Xue;Nie Lei
    . 2005, 7(6): 418-421.
    Objective: To investigate norvancomycin use in surgical patients and evaluate the rationality and cost of medications. Methods: 253 surgical cases under norvancomycin therapy were collected and analysed retrospectively and at random. Results: Norvancomycin administration could be irrational in many ways, mainly untimely use before operations (97.6%) misuse(92.9%)and overlong use of more than 2 days after operations(88.9%). Norvancomycin was used with other 2-3 other antibiotics simultaneously in 8 cases and even with antagonistic antibiotics in 11 cases. The per case expence of norvancomycin was 1910.32 Yuan and accounted for 30.28% of the total drug expenses in this survey. Conclusion: Norvancomycin is the last choice in curing Gram-positive bacterial infection and its irrational use should be avoided in order to diminish the adverse reactions.
  • 病例报告
    Di Yanan;Peng Deyin
    . 2007, 9(5): 357-357.
    A 54-year-old man with decompensated cirrhosis was given recombinant human granulocyte colony stimulating factor(rhG-CSF)200 μg once daily subcutaneously.The next day,dark urine occurred.On day 4,he developed palpebral oedema,gross hematuria,and oliguria.His level of BUN increased from 4.8 mmol/L to 7.9 mmol/L(maximum:13.9 mmol/L),and the level of Cr increased from 113 μmol/L to 154 μmol/L(maximum:308 μmol/L).rhG-CSF was withdrawn.The patient was treated with reduced glutathione,tiopronin,furosemide,and symptomatic and supportive treatment.Two weeks later,the patient,s renal function returned to normal limits.
  • 临床论著
    Cui Shijun;Zhang Jian;Gu Yongquan;Yu Hengxi;Li Jianxin;Wang Zhonggao
    . 2010, 12(4): 234-6.
    Objective: To assess the efficacy and safety of lauromacrogol 400 for the treatment of varicose veins of the lower extremities. Methods: A prospective, randomized, doubleblind trial was conducted. Ninety six outpatients from March 2008 to March 2009 in Xuanwu Hospital of Capital Medical University were selected into the phase Ⅱ clinical trials investigating the treatment of varicose veins of the lower extremities with lauromacrogol 400. Of them, 5 patients were males and 91 were females with an average age of (46±10) years. The varicose veins were classified into spider veins, reticular veins, and medium to largesized veins according to the types. Each type of varicose veins comprised 32 patients, which were allocated in a ratio of 3:1 into the treatment group (24 cases) and control group (8 cases), respectively. The patients with spider veins, reticular veins, and medium to largesized veins in the treatment group were injected with 0.5%(0.1-0.2 mL), 1% (0.1-0.3 mL), 3% (0.5-2.0 mL) lauromacrogol 400 into their varicose veins, respectively; and the patients in the control group received the same volume of water for injection, respectively. The patients received 1 to 3 treatment courses, and each course was 2 to 4 weeks. The main criterion for efficacy (improvement of varicose veins) and the secondary criterion for efficacy (patients’satisfaction), adverse reactions were observed; efficacy and safety of the drug were assessed. Results: Eighty-eight patients completed the trial, and 8 was lost during the trial. The response rates in the patients with spider veins, reticular veins, and medium to largesized veins in the treatment group were 87.0%, 95.2%, and 82.6%, respectively; and 0, 14.3%, and 0 in the control group, respectively. The differences were statistically significant in comparison of the corresponding values between the treatment and control groups (all P<0.05). The scores of patients’satisfaction in the treatment group were 4.43±1.16, 4.75±0.44, and 3.58±1.44, respectively; and 2.33±0.82, 2.43±1.13, and 2.25±0.71 in the control group, respectively. The differences were statistically significant in comparison of the corresponding values between the treatment and control groups (all P<0.05). The scores of safety assessment in the treatment group were 4.87±0.34, 4.70±0.47, and 4.28±0.90, respectively; 4.67±0.52, 4.90±0.01, and 4.88±0.36 in the control group, respectively. The differences were not statistically significant in comparison of the corresponding values between the treatment and control groups (all P>0.05). The incidence rate of adverse reactions in the treatment and control groups were 37.5% and 25.0%, respectively. The difference was not statistically significant between the treatment and control groups (P>0.05). Conclusion: Lauromacrogol 400 injection is an effective and safe drug for the treatment of varicose veins of the lower extremities.
  • 病例报告
    YU Xiao-ling
    . 2012, 14(5): 312-2.
    A 37-year-old woman with HIV received IV cefoperazone sodium and sulbactam sodium 3.0 g once daily via a pump for pulmonary infection. On day 21, the drug therapy was changed to oral moxifloxacin 400 mg once daily. On day 3 of oral moxifloxacin therapy, the patient developed skin pruritus. On day 7, her face and entire body developed numerous red papules and skin pruritus with red swelling. Drug eruption was suspected. Moxifloxacin was stopped. Anti-allergic drugs such as calcium gluconate, dexamethasone, and loratadine were given. Two days later, she presented with diffuse dark red patch, scaly skin, generalized swelling and difficulty keeping eye open, and edema in her lower extremities. After 8 days, she had exfoliative desquamation on her face and trunk, and her pruritus gradually subsided.
  • WANG Xiao-jun;ZHAN Wei-hua;ZHENG Zao-qian
    . 2013, 15(6): 355-1.
    A male patient aged 26 years received intramuscular infusion of ketorolac tromethamine 30 mg for abdominal pain. About 5 minutes after injection finish, the patient felt dizziness and weakness. Meanwhile, he developed generalised sweating and syncope. His blood pressure was 65/40 mm Hg and heart rate was 108 beats/min. He was immediately given oxygen inhalation, intravenous infusion of epinephrine, dexamethasone, and metaraminol, and intramuscular promethazine. About 30 minutes later, the patient came to his senses and his symptoms gradually improved with a blood pressure of 105/75 mm Hg and a heart rate of 80 beats/min. Thereafter, no discomfort recurred
  • Liu Jiaming, Bai Xiangrong, Chu Yanqi, Tang Jing, Zeng Yan, Wang Yuqin, Yan Suying
    . 2017, 19(4): 246.
    ObjectiveTo investigate the impact of trigger refinement on adverse drug event (ADE) detection efficiency through applying Global Trigger Tool (GTT).MethodsThe sample of medical records of patients discharged from Xuanwu Hospital of Capital Medical University from January 1st to June 30th 2014, and from July 1st 2014 to June 30th 2015 were selected randomly. The medical records of former period were reviewed by using unrefined ADE triggers (including 30 items) and refined triggers (including 8 items), respectively. The medical records of latter period were reviewed by using refined ADE triggers. All medical records were reviewed manually. The medical records were checked thoroughly in order to identify ADEs after detecting trigger. The classification of the severity of ADE was categorized by the National Coordinating Council for Medication Error Reporting and Prevention index of E to I. The ADE detection rate and positive predictive value (PPV) of ADE in the medical records in different period using unrefined triggers and/or refined triggers were compared.ResultsFour hundreds and eighteen medical record samples from January to June 2014 were reviewed using unrefined ADE triggers. ADE occurred in 38 of the 418 cases. The ADE detection rate was 9.1%. Fifty-three ADEs were identified to be associated with 38 patients. The top 3 ADEs were abnormal hepatic function, diarrhea, and rash. Fifty ADEs were classified as E (94.3%), and 3 ADEs were classified as F(5.6%). The top 3 drugs caused ADE were antibiotics (15 cases), antineoplastics (6 cases), and hormone and related drugs (6 cases). Twenty-three triggers could be detected from 30 triggers. The times of positive detecting of triggers were 552. The 35 ADEs were identified. The PPV was 6.3% (35/552). The 30 triggers were refined based on the above-mentioned results. There were 8 refined triggers by deleting undetected triggers and removing the triggers which could be detected, but it was difficult to judge the causality with drugs. The same 418 records were reviewed again by applying the refined triggers. ADE occurred in 33 patients. The ADE detection rate was 7.9%. Forty-four ADEs were identified to be associated with the 33 patients. The top 3 events were diarrhea, abnormal hepatic function, and rash. Forty-one ADEs were classified as E (93.2%), and 3 ADEs were classified as F (6.8%). The top 3 most commonly implicated drug classes were antibiotics (13 cases), central nervous system drugs (5 cases), and hormone and related drugs (4 cases). All 8 triggers could be detected. A total of 120 times of detections were checked. Twenty-five ADEs were identified. The overall PPV was 20.8%. The difference of PPC between the refined triggers and the unrefined triggers was statistically significant (P<0.05). Eight hundreds and thirty-seven medical records sample from July 2014 to June 2015 were reviewed by using refined ADE triggers. ADE occurred in 60 of 837 cases. The ADE detection rate was 7.2%. Seventy-four ADEs were identified to be associated with the 60 patients. The top 3 events were rash, vomiting, and abnormal hepatic function/diarrhea/nausea. Seventy ADEs were classified as E (94.6%) and 4 ADEs were classified as F (5.4%). The top 3 most commonly implicated drug classes were antibiotics (14 cases), antineoplastics (9 cases), and central nervous system drugs (9 cases). All 8 triggers could be detected. A total of 252 times of detections were checked. Twenty-five ADEs were identified. The overall PPV was 9.9%. The difference of PPC between the refined triggers and the unrefined triggers was not statistically significant (P>0.05).ConclusionsThe refined triggers can improve the efficacy of ADE detection of GTT and increase the PPV. Decrease of the number of triggers has no effect on confirming the categories and severities of ADE and can be easily implemented.
  • Wang Chao, Zhao Liming, Tan Tao
    Adverse Drug Reactions Journal. 2021, 23(3): 160-162. https://doi.org/10.3760/cma.j.cn114015-20200803-00836
    A 57-year-old male patient was given pemetrexed and carboplatin chemotherapy (on day 1) combined with camrelizumab (on day 2) immunotherapy for lung adenocarcinoma, 21 days for a cycle. The patient developed elevated alanine aminotransferase after medication in the 2nd and 3rd cycle, which was considered to be caused by chemotherapy. Then the chemotherapy was stopped and only immunotherapy was continued. After the 4th immunotherapy, vascular nevus appeared on the patient′s face, neck, and back, ranging in different sizes (0.1-1.2-cm), red or red and black, and higher than the skin surface. It was considered to be the reactive cutaneous capillary endothelial proliferation caused by camrelizumab. Due to patient′s condition, immunotherapy was continued. Vascular nevus with larger size was surgically removed and bevacizumab was added to prevent angiogenesis. At 6-month of follow-up, the vascular nevus was found not at the excision site but in other parts.
  • 病例报告
    WEN Zhen-hua;LI Jing-yang;Zhang Liang
    . 2012, 14(4): 251-2.
    A 28-year-old female patient receive an IV infusion of methylprednisolone 40 mg once daily for systemic lupus erythematosus. On day 5, an IV infusion of cyclophosphamide 0.8g was added to the regimen, at the same time she was given hydration therapy and urinary alkalinization. The next day, she developed gross hematuria. Her urinary sediment counting for 3 hours revealed 1.63×106 RBCs/hour with 90% isomorphic RBCs. Cystoscopy revealed hemorrhage of bladder mucosal. Hemorrhagic cystitis induced by cyclophosphamide was considered. Methylprednisolone was continued, and she received etamsylate, adequate hydration therapy and urinary alkalinization. Gross hematuria disappeared after 3 days. Two weeks later, a repeat urine sediment examination was normal. Fifteen days later, the patient was retreated with cyclophosphamide pulse therapy and, at the same time, she was given an IV infusion of mesna, hydration therapy and urinary alkalinization. Hematuria did not reappear.
  • 论著
    Chen Xue①;Qi Huanying①;Jiang Bin②;Zhang Jianzhong①
    . 2007, 9(4): 239-242.
    Objective: To investigate the relationship between bimolane/ethylimine treatment and secondary leukemia in patients with psoriasis. Methods: According to entry criteria, 189 patients hospitalized for psoriasis during the period from January 1990 to March 2006 were enrolled. Of the 189 patients, 39 patients with secondary leukemia entered into the case group (22 patients had received bimolane/ethylimine) and 150 patients without secondary leukemia entered into the control group (19 patients had received bimolane/ethylimine). The odds ratio(OR) of secondary leukemia, type of leukemia, and chromosome aberration rate in the patients who had received or had not received biomolane/ethylimine treatment were analyzed. Results: Of the 41 patients who had received bimolane/ethylimine treatment, 22 patients(53.66%) developed leukemia. And of the 148 patients who had not received bimolane/ethyline treatment, 17 patients(11.49%) developed leukemia (OR=8.92, 95% confidence interval=3.7621.44, P<0.01). Chromosome examination revealed that 10(83.33%) of 12 patients who had received bimolane/ethylimine treatment had chromosome aberration and 5(62.50%) of 8 patients who had not received bimolane/ethylimine treatment had chromosome aberration, the rate of chromosome aberration had no stastistically difference (P>0.05).Acute promyelocytic leukemia (M3) was the predominant type (53.85%) followed by acute granulocytic leakemia (M2) (25.64%). Conclusion: Secondary leukemia may be associated with bimolane/ethylimine used in the treatment for psoriasis. Granulooytic leukemia is the main form of leukemiainduced by bimolane/ethylimine.
  • 论著
    Liu Guangjian;He Guohou;Huang Chaofen;Wang Yunfu;Ye Tianxiong;Fan Huayan
    . 2007, 9(3): 166-168.
    Objective: To compare the efficacy and safety of paroxetine plus low-dose amitriptyline with paroxetine use alone in treating patients with depressive sleep disorder. Methods:Sixty patients were randomly divided into two groups: group A and group B. The patients in the group A were given paroxetine 20 mg/day in the morning. The patients in the group B were given paroxitine 20 mg/day in the morning and amitriptyline 6.2525 mg at 12 h before bedtime at night. The duration of therapy was six weeks. HAMD was scored before the therapy and in the end of 2nd, 4th, and 6th week after the therapy. The adverse reactions of patients in the two groups were observed and recorded, while the"Sleep Difficulty Form"was filled by the patients every day. Results:After six weeks of treatment, the patients in the two groups were improved in their feeling of sleep. Compared with the group A, the group B had more rapid and sustained action to facilitate sleep (P<0.01). There were no statistically differences in other clinical effects between the two groups (P>0.05). The common adverse reactions in the group A were anxiety and insomnia at the initiation of therapy, and in the group B were dry mouth, constipation, and decreased sexual function. Conclusion:Compared with paroxetine use alone, paroxetine plus low-dose amitriptyline is more effective and safer in treating the depressive sleep disorder
  • Yan Chunyan
    Adverse Drug Reactions Journal. 2010, 12(1): 60-1.
    A 67yearold man recevied an IV infusion of compound amino acid 250 ml once daily after undergoing resection of esophageal cancer. On day 3, the patient developed chest distress, short of breath, nausea, and polyhidrosis after infusion of compound amino acid about 15 ml. Compound amino acid was discontinued immediately, and then an IM of promethazine hydrochloride and an IV push of dexamethasone, adrenaline, lidocaine, and nikethamide were given. Meanwhile he underwent artificial respiration, external chest compression, and endotracheal intubation. Two hours later, the resuscitation was unsuccessful and he died.
  • 论著
    Xu Guoxun;Xue Jixiu*;Fan Long;Wang Yuqin
    . 2007, 9(6): 393-396.
    Objective:To investigate the effects of medications used in anaesthesia on insulin resistance in elder patients with cholelithiasis.Methods:Forty patients with cholelithiasis undergoing cholecystectomy or biliary duct exploratory surgery were divided into two groups:the elder patients group(≥60 years,8 males,12 females) and the non-elder patients group(<60 years,9 males,11 females).All patients received midazolam 0.05 mg/kg and atropine 0.5 mg by intramuscular 30 minutes before operation,followed by midazolam 0.08 mg/kg,fentanyl 2~3 μg/kg,propofol 1.5~2 mg/kg,and vecuronium bromide immediately after they entered the operating room.The patients were given propofol 2~4 mg/(kg·h),and isoflurane 0.5%~2% during operation.TNF-α,IL-6,insulin,and blood glucose were measured before anaesthesia,60 minutes after anaesthesia,and 24 hours after operation.Results:TNF-α,IL-6,blood glucose,insulin,and insulin resistance in the two groups markedly increased 60 minutes after anaesthesia compared with before anaesthesia(P<0.05).TNF-α,blood glucose,and insulin resistance in the elder patients group were higher than those in the non-elder patient group(P<0.05).TNF-α,IL-6,blood glucose,insulin,and insulin resistance increased in both group 24 hours after operation(P<0.05).Differences of TNF-α,blood glucose,and insulin resistance between the two groups were statistically significant(P<0.05).Conclusion:Medications used in anaesthesia may affect insulin resistance,especially in elder patients.
  • 论著
    Wang Jiazhi;Liu Shumin;Zhao Yan;Tang Qing
    . 2009, 11(1): 13-4.
    Objective: To observe rat liver cell injury induced by diterpene lactiones extracted from Dioscorea bulbifera L. Methods:Dioscorea bulbifera pieces 3 kg were extrated with alcohol 75%, and alcoholic extract was extracted with chloroform, and then 22 g of extract were obtained; 18 g of the extract were mixed with 40 ml of Tween 80 (polysorbate 80), and then diluted with distilled water until the resulting suspension was 0.044 g/ml. Twenty SD male rates were divided into the following two groups: the extract group and the control group (10 rates in each group). In the extract group, 2.5~3 ml (dose calculation based on bodyweight, 1.19 g/kg) of the extract suspension were poured into the rats' stomach two times daily for 7 days. In the control group, the rats were given an equal volume of distilled water containing the same amount of Tween 80 two times daily for 7 days. The appearance, activity, and food intake were observed. After 7 days, the rats were weighed, liver glutathione peroxidase (GSH-PX), catalase (CAT) and superoxide dismutase levels were measured, the liver index was calculated, and the liver cell ultrastructure was observed under transmission electron microscopy. Results: Dry, brittle and dull hair, hair loss, hypoactivity, lying curled up, and reduced food intake occurred in rats in the extract group, The change rate of rat's weight in the extract and control groups was (0.929±0.032)% and (1.170±0.046)%, respectively. The difference was statistically significant(P<0.01). The liver index in the extract and control groups was 14.54±2154 and 8.602±0.170, respectively. There was statistically significant difference(P<0.01);GSH-PX, CAT, and SOD levels in the extract and control groups were (157.63±57.44) U/L and (0.92±0.61) U/L, (131.12±27.54) U/L and (375.41±46.92) U/L, (6.44±2.25) U/L and (253.05±34.84) U/L, respectively. The differences were statistically significant (all P<0.01). Ultrastructually, markedly increased lipid droplets and smooth endoplasmic reticulum, swelling and myeloid changes of mitochrondia, dissolution of surface microvilli of hepatocytes, and unclear perisinusoidal space were found in the extract group. Conclusion: The diterpene lactones extracted from Dioscorea bulbifera have liver cell toxicity. The machanism may be associated with diterpene lactoneinduced oxidative damage to hepatocellular mitochrondia.
  • 综述
    . 2000, 2(4): 216-220.
  • Zhang Chong, Chen Guiju, Pan Jie, Lu Juan, Cheng Yujie
    Adverse Drug Reactions Journal. 2023, 25(4): 229-236. https://doi.org/10.3760/cma.j.cn114015-20220515-00428
    Objective To explore the effects of inhaled budesonide (i-BUD) on the growth rate and height of asthmatic children. Methods Databases of PubMed, Embase, Cochrane Library, CNKI, and Wanfang were searched (up to April 30, 2022), and randomized controlled trials (RCTs) and high-quality cohort studies on the effects of i-BUD on growth rate and height in asthmatic children were collected. Patients in the observation group were treated with i-BUD, and those in the control group were treated with placebo or no drug. The outcome index was the height and growth rate of the children in short- and long-term treatment with i-BUD. The Cochrane Collaboration risk of bias assessment tool was used for methodological quality assessment of RCT studies, and the Newcastle Ottawa scale (NOS) was used for quality assessment of cohort studies. Stata 11.0-software was used for the meta-analysis, and the effect sizes were expressed as mean difference (MD) with its 95% confidence interval (CI). Results A total of 16-studies were included in the meta-analysis (15 RCTs and 1 cohort study), including 2-578 patients in the observation group and 2-422 in the control group. Risk of bias was low in 9 of the 15 RCTs, high in 2 RCTs, and unclear in 4 RCTs. The NOS score of the only prospective cohort study was 8 (high quality). The short-term effects of i-BUD on the growth rate of the lower limbs in children were examined in 6 studies. The exposure time to i-BUD in children in the observation group ranged from 2 to 8 weeks and the meta-analysis showed that the growth rate of lower limbs of children was significantly slower than that of children in the control group (MD=-0.18-mm/week, 95%CI: -0.24--0.13 mm/week, P<0.01). Subgroup analysis by dose showed that the growth rate of children′s lower limbs was similar in the 2 groups at 200 μg/d of inhaled i-BUD (MD=-0.10-mm/week, 95%CI: -0.25-0.05 mm/week, P=0.209); the growth rate of children′s lower limbs was significantly lower in the observation group at 400-μg/d and 800-μg/d of inhaled i-BUD than that in the control group (MD=-0.17-mm/week, 95%CI: -0.23--0.10 mm/week, P<0.01; MD=-0.34-mm/week, 95%CI: -0.48--0.20 mm/week, P<0.01). The effect of long-term (≥1 year) exposure to i-BUN on children′s height was observed in 10 studies. The meta-analysis showed that the height of children under long-time exposure to i-BUD was significantly lower than that of children in the control group (MD=-0.72-cm, 95%CI: -0.86--0.58 cm, P<0.01). The subgroup analysis according to the i-BUD exposure time showed that the height of children with 1-year, 2-years, and 4-6 years of i-BUD exposure was significantly lower than that in the corresponding control group (MD=-0.60-cm, 95%CI: -0.75--0.44 cm, P<0.01; MD=-1.30-cm, 95%CI: -1.70--0.90 cm, P<0.01; MD=-1.15-cm, 95%CI: -1.67--0.64 cm, P<0.01), but the impact of i-BUD on height of children was not significant when the average exposure time was 9.2 years (MD=-0.60-cm, 95%CI: -2.15-0.95 cm, P=0.448). Conclusion Short-term and long-term application of i-BUN both may affect the growth rate and height of asthmatic children.
  • 调查研究
    Mao Lu;Li Jing;Zhen Jiancun
    . 2008, 10(4): 0-0.

    Objective: To investigate the amoxicillininduced renal damage and its clinical characteristics. Methods: The case reports of amoxicillininduced renal damage were collected from medical literature between 1979 and 2007. The dosage and administration of amoxicillin and onset time and clinical characteristics of adverse reactions were analyzed. Results: The patients with amoxicillininduced renal damage were 32 cases [11 men, 21 women, average age (38.95±23.53) years]. Of the 32 patients, 16 received amoxicillin alone, 9 received amoxicillin combination with other drugs, 7 received amoxicillin/clavulanate potassium; 21 was administered by intravenous infusion, 9 was administered by mouth, and two patients’route of administration was not stated. Of the 32 patients, 20 patients' dosage exceeded the common dosage limits, and one patient’s dosage was not stated. The renal damages caused by amoxicillin were acute renal failure, acute interstitial nephritis, and hematuria. The average onset time of renal damage was (8.57±3.10) days in usual dosage and (1.05±1.57) days in overdose. Conclusion: Amoxicillin can cause severe renal damage, especially in overdose.

  • 论著
    Xu Juan;Ji Bingxin;Su Li;Sun Xuejing;Liu Congyan
    . 2008, 10(5): 0-0.

    Objective: To investigate the efficacy and safety of hematopoietic stem cell mobilization by granulocyte colony-stimulating factor (G-CSF) in patients with progressive multiple sclerosis (MS). Methods: Thirtyfour patients with secondary progressive MS were enrolled in a study. G-CSF 5 μg/kg daily for 4~6 days was used for mobilization of autologous hematopoietic stem cells. Mononuclear cells (MNCs) after mobilization were collected by blood cell separator. The absolute numbers of CD34+ cells and mononuclear cells were detected by flow cytometry. The type and incidence of adverse reactions were observed after G-CSF therapy. The expanded disability status scale (EDSS) was used to evaluate the condition of the patients before and after G-CSF therapy. Results: The numbers of collected CD34+ cells and MNCs cells were (2.68±0.89)×106/kg and (2.98±1.19)×108/kg, respectively. After transplantation, the median time of neutropil returning to >0.5×109/L and platelet returning to >50×109/L was 13 days (range 9-17 days) and 16 days (range 11-21 days), respectively. Transplantationrelated mortality was zero. Seventeen patients (50%) presented with muscle pain and fatigue, but the symptoms resolved without medication. Two patients experienced an increase in 0.5 points on the EDSS after mobilization by G-CSF, but no statistically significant difference was observed compared with before mobilization (P=0.16). Conclusion: The efficacy and safety of mobilization by G-CSF alone can meet the clinical requirement for autologous hematopoietic stem cell transplantation in treating patients with progressive MS.

  • 药物滥用
    Liang Juncehng① Xu Guozhu① Shen Liyang① Yang Jianhui② Xiao Zaoxiang② Li Jun② Deng Yanping①
    . 2006, 8(2): 117-120.
    Objective: To observe the efficacy and safety of TAIKANGNING capsules for the treatment of heroin withdrawal symptoms. Methods: Fifty heroin-dependent patients were treated with TAIKANGNING capsules in an open trial. The usual oral dose of TAIKANGNING was 1.5~3.0g, three times daily. The dosage of the drug was administered according to the withdrawal symptoms. The maximum dose was 4.0g three times daily for 10 day. Daily changes of total scores in withdrawal symtoms, daily changes of scores in each main withdrawal symptoms and changes of scores in HAMA(Hamilton anxiety scale)were adopted as index of detoxification efficacy. Results: The daily changes of total scores in withdrawal symptoms, daily changes of scores in each main withdrawal symptoms and changes of scores in HAMA were greatly reduced after administration of TAIKANGNING capsules. The difference was significant statistically in comparison with those of before treatment(P< 0.001). The adverse reactions of TAIKANGNING capsules including nausea, vomit, diarrhea, dry mouth, blur version were observed. The influence of the drug on breath, heart rate and blood pressure was not found. Conclusion:TAIKANGNING capsules is effective and safe in the detoxification of heroin-dependent patients.
  • 中毒救治
    . 2003, 5(4): 248-250.
  • 安全合理用药
    Fang Zhenwei①②;Zhai Suodi①*
    . 2007, 9(6): 397-400.
    Erlotinib is a tyrosine kinase inhibitor of epidermal growth factor receptor.It is used in second-and third-line treatment of patients with locally advanced or metastatic non-small cell lung cancer.The common adverse reactions to erlotinib are acneiform skin rash and diarrhea.The incidence of rash is 61.2%~82.0%.Typically,the rash involved the face,neck,and trunk.Rash onset is usually about 1 week after starting therapy,with maximal intensity in the second or third week.It usually subsides by week 4 in most patients,although it does persist for longer periods in a few patients.Clinical trial shows that the rash is dose-related,and overall survival in the patients who develop a moderate to severe rash is longer than the patients who have a mild rash or none at all.Development of an erlotinib-associated rash may be an indicator that the drug is effective in treatment of lung cancer.
  • 病例报告
    Wang Huimin;Ji Lisha
    . 2007, 9(5): 361-362.
    A 54-year-old man with diarrhea accompanied by pus and blood stool was given compound sodium phosphate tablets 80 tablets in 2 divided doses by mouth for bowel cleansing before electronic colonoscopy.Five hours after administration,the patient developed urinary retention.After the treatment of urethral catheterization,the symptom was relieved.The next day,the urinary retention did not recur
  • 实验研究
    Du Jiaxin;Ma Manling;Gu Yuhong
    . 2010, 12(3): 166-3.
    Objective: To observe the effects of fenofibrate on rat erectile function and testosterone level in order to explore the reasons of fenofibrateinduced erectile dysfunction(ED). Methods:Thirty female SD rats were unsexed and, 2 weeks later, received SC injection of estradiol benzoate 20 μg and progesterone 500 μg 48 hours and 4 hours before mating experiment, respectively. Thirty male SD rats were randomly divided into two groups: the fenofibrate group and the control group. Each group comprised 15 rats. The rats in the fenofibrate group were gavaged with fenofibrate (31.5mg/kg) dissolved in distilled water (total volume 4mL) once daily for 14 days. The rats in the control group were gavaged with same volume of distilled water once daily for 14 days. The mating experiment was performed on the first day after medication withdrawl. The mount frequency (MF), intromission frequency (IF), mount latency (ML) and ejaculation latency (EL) of the rats in the two groups within 30 minutes were observed and recorded. The levels of testosterone in serum and penile tissue were measured using radioimmunoassay. Results:The MF and IF of rats in the fenofibrate group were (9.45±1.65), (4.15±1.38) times/min, ML and EL were (14.0±7.0), ( 5.3±5.9) minutes, respectively. The MF and IF of rats in the control group were (31.23±3.85), (12.8±3.02) times/min, ML and EL were (6.2±4.3), (16.2±6.0) minutes, respectively. The differences were statistically significant (all P<0.05). The levels of the testosterone in serum and penile tissue were (51.26±34.15), (62.57±46.37)nmol/L in the fenofibrate group, and (153.72±83.98), (164.89±94.02) nmol/L in the control group, respectively. The differences were statistically significant (all P<0.05). Conclusion: Fenofibrate can decrease rats’erectile function and testosterone level. The decreasing testosterone level induced by fenofibrate might be one of the main reasons of ED.
  • 病例报告
    Mao Sufang;Yan Tingnian
    . 2007, 9(4): 264-266.
    A 55-year-old woman with headache caused by mild cerebral vasospasm received nimodipine 30 mg thrice daily.Ten days later,the patient developed distending pain of renal region,frequent nocturia,dark and turbid urine.The urine routine test revea-led protein(+++),blood cell(+++),glucose(+).Renal function examination showed the following values:BUN 6.1 mmol/L,Cr 129.3 μmol/L.Nimodipine was stopped.She was administered with carbazochrome 5 mg and vitamin K 4 mg thrice daily.Five days later,the symptoms disappeared.The reexaminations showed that urine routine and renal function were normalized.
  • 调查研究
    Tao Ye
    . 1999, 1(3): 162-164.
    Objective: To understand the contradictory effects of scopolamine in the treatment of asthma. Methods: The health condition of 9 old patients being treated with scopolamine for chronic bronchitis or pulmonary heart disease was analyzed. Results: 9 patients with dyspnea were exacerbated due to intravenous infusion of scopolamine. Six of nine patients turned to be unconscious and one died. Conclusion: In the treatment of senile chronic bronchitis and pulmonary heart disease, scopolamine should not be used, and other anticholinergics be used with care.
  • ADR咨询
    . 2006, 8(5): 396-396.
  • Duan Wenqi, Pei Yanyu, Zhao Ming, Yang Liping
    Adverse Drug Reactions Journal. 2021, 23(4): 184-189. https://doi.org/10.3760/cma.j.cn114015-20201218-01252
    Objective To explore the factors influencing the severity and prognosis of vancomycin- associated acute kidney injury (AKI). Methods Case reports on vancomycin-associated AKI were collected by searching the relevant databases home and abroad up to June 2020. Patients′ relevant information such as general condition, underlying diseases, infecting species, treatment of vancomycin, baseline serum creatinine (Scr), baseline estimated glomerular filtration rate (eGFR), time from medication to onset of AKI, Scr elevation rate, eGFR decline rate, management of AKI, and outcomes were recorded and descriptively analyzed. The influence factors of the rates of Scr elevation and eGFR decline in patients were analyzed using robust regression method and the influence factors of the prognosis of vancomycin-associated AKI were analyzed by comparing the main clinical features of patients with basic recovery and improvement of Scr level. Results A total of 81 reports involving 109 patients were enrolled in the analysis, including 65 males and 44 females, aged from 1 to 84 years with a median age of 49 years, of which 20 were ≤15 years old and 61 (56.0%) suffered from underlying chronic diseases. The median daily dose of vancomycin was 2.00 (0.75, 6.00) g in 89 adult patients and 40.0 (10.3, 240.0) mg/kg in 20 pediatric patients. The median time from medication to onset of AKI was 7 (1, 135) days, and 80 (73.4%) occurred within 14 days after first medication. Seventy-five patients (68.8%) had concomitant use of drugs with potential nephrotoxicity. The median value of peak Scr was 408 (53, 1-000) μmol/L, and the median eGFR was 44.3 (4.2, 280.7) ml/(min·1.73 m2) after developing AKI. Steady-state trough concentration of vancomycin was recorded in 57 patients, which was 46.2 (11.8,284.0) mg/L before or at onset of AKI. Except 4 patients died and 1 patient was lost to follow-up, the Scr level basically recovered in 50 patients, were improved in 51 patients, and did not recover in 3 patients, which required continuous renal replacement therapy. Robust regression analysis showed that the trough concentration of vancomycin and the number of concomitant nephrotoxic drugs were significantly correlated with the rates of Scr elevation and eGFR decline after AKI (all P<0.05). The age and peak Scr in patients with basic recovery of renal function were significantly lower than those in patients with improved renal function (all P<0.001), while the lowest eGFR value was significantly higher(P=0.036). Conclusions Patients with higher trough concentration of vancomycin and more nephrotoxic drugs would have greater elevation of Scr and the decline of eGFR. Older age, higher Scr peak value, and lower eGFR was associated with worse recovery of the renal function.
  • Wang Zixin, Liu Lijie, Meng Qingling, Chen Wei, Zhang Jing, Zheng Hui, Ji Congying
    . 2016, 18(4): 273.
    ObjectiveTo explore the safety of salbutamol and doxofylline treatments with different orders.MethodsThe subjects were inpatients who need to be treated with salbutamol and doxofylline in Department of Respiratory and Critical Care Medicine Ward, Beijing Hospital during September 2012 to December 2014. Firstly, the nurses were divided into A, B, and C groups and the admitted patients in accordance with inclusion criteria were entered into the  on-duty nurses′ group. The patients in the group A received intravenous injection of doxofylline after salbutamol inhalation, the patients in the group B received salbutamol inhalation and intravenous injection of doxofylline at the same time, and  the patients in the group C received salbutamol inhalation after intravenous injection of doxofylline (a total of 1 to 2 treatment cycles, the treatment was stopped if adverse reactions occurred). The adverse reactions in the 3 groups were observed.ResultsEach group comprised 100 patients. There were 63 males in the group A and average age was (71±13) years; 58 males in the group B and average age was (71±12) years; 64 males in the group C and average age was (73±12) years.  The diseases in patients in the 3 groups included chronic obstructive pulmonary disease, pneumonia, lung cancer, lung infection, bronchiectasis, and bronchial asthma, etc. The differences of age, gender distribution, and percentages of different diseases among the three groups were not statistically significant (all P>0.05). Totally 24 cases of adverse reactions appeared in 16 patients in the 3 groups, including 12 cases of palpitations, 10 cases of shortness of breath, and 1 case of finger tremor. The incidence of adverse reactions in the 3 groups were 2% (2/100), 10% (10/100), and 5% (5/100), respectively. The difference between the group A and the group B was statistically significant (P=0.045).ConclusionsSalbutamol inhalation and intravenous injection of doxofylline with different order had an marked impact on medication safety. The incidence of adverse reactions was the lowest when the patients were given intravenous injection of doxofylline after salbutamol inhalation.
  • Yu Yuncui, Yang Yu, Xu Yang, Cai Ting, Nie Xiaolu, Liu Yiwei, Peng Xiaoxia, Zhan Siyan, Wang Xiaoling, Jia Lulu
    . 2017, 19(3): 168.
    ObjectiveTo explore the feasibility of post-marketing active safety surveillance for pediatric medication based on big medical data.MethodsA questionnaire on hospital information systems was conducted using cross-sectional study method in 17 children′s hospital of Beijing Children′s Hospital Group during May to July, 2016. Variables for post-marketing active safety surveillance for pediatric medication was designed in the questionnaire which included 146 questions of six aspects, database features, degree of computerization (including 21 variables), degree of structuring (involving 39 variables), data type, data encoding, degree of linkage on information systems, and data sharing willingness. The data were analyzed using Excel 2007 software.ResultsThe recovery rate of the questionnaire was 100%. There were 17 children′s hospitals, of them, 14 hospitals were level 3 A and 3 hospitals were level 3 B, distributed in 17 provinces or regions in China. Data starts from 1999 to 2014 in the different hospitals′ information systems with a total of 60 million children′s medical records. The 21 variables used to evaluate the degree of computerization computerized in all departments in 10 hospitals and in half of the departments in 2 hospitals. Of the 39 variables used to evaluate the degree of structuring, 10 variables structured in the 17 hospitals, 23 variables structured in the 10-16 hospitals, and 6 variables structured in the 2-6 hospitals. However, there was a big difference in the data types and data coding among the information systems. The data encoding were mostly based on the hospital standard. Four modules of variable information (baseline information, drug exposure,diagnosis information, laboratory test) could be linked by a uniform number in 10 hospitals, partially linked in 7 hospitals. Meanwhile, 12 hospitals have the willing to share the desensitization data to support post-marketing drug safety studies. ConclusionsMost children′s hospitals in this study have willing and conditions to integrate data of different modules of information systems to form the data chain. It is feasible to monitor actively the post-marketing safety of children′s drugs based on the big medical data. However, the medical data need to be further standardized firstly because of the big difference in the data structure and types among the medical systems.
  • Song Chunrong, Wei Qiang, Zhang Li, Xu Yi, Duan Meifan
    Adverse Drug Reactions Journal. 2020, 22(6): 377-378. https://doi.org/10.3760/cma.j.cn114015-20190930-00791
    A 32-year-old female patient with nephrotic syndrome got pregnant during treatments with losartan potassium tablets (50-mg once daily), methylprednisolone tablets(12-mg every other day), and dipyridamole tablets(50-mg once daily). She continued these drugs during pregnancy. Ultrasonographic examination at 24+2 weeks of gestation indicated oligohydramnios, which lasted until 32+2 weeks of gestation. The amniotic fluid volume ranged 1.1-3.4-cm, and the amniotic fluid indexes were 1.9-6.9-cm. Losartan and methylprednisolone were discontinued, and nifedipine controlled released tablets (30-mg once daily) were given to reduce blood pressure. Amniotic fluid volume gradually increased to normal. At 34+4 weeks of gestation, her blood pressure rose to 177/113-mmHg. Preeclampsia was diagnosed. She was treated with magnesium sulfate (IV infusion at a speed of 1 g/h), oral nifedipine controlled released tablets(60-mg once daily) and labetalol (200-mg twice daily). Then her blood pressure was 143/82-mmHg and urinary protein detection was positive (++). At 35+3 weeks of gestation, a baby boy was delivered by cesarean section, with a body length of 43-cm and a weight of 2 200 g. Neonatal Apgar scores at 1-min and 5-min were both 10, and no birth defects were found. During the follow-up to 24 months of age, his growth and development were good, and intellectual development and physical exercise were normal.
  • 中药不良反应
    Guo Dongjie;Li Jingshan
    . 2007, 9(6): 446-447.
    A 32-year-old man with chronic viral hepatitis B was administered with 40 ml of compound glycyrrhizin injection mixed with 100 ml of sodium chloride injection 0.9% once daily by intravenous infusion for 11 days.And then the dosage of compound glycyrrhizin injection was increased to 100 ml mixed with 250 ml of sodium chloride injection 0.9% once daily for 7 days.The patient developed dizzy,eyes distending,mild blurred vision during intravenous infusion every day.Despite discontinuation of the drug,his blurred vision was aggravated.Ophthalmological examination revealed bilateral papilloedema,swelling 1 D,blurring of the optic disc margins with minor bleeding.The patient's BP was 90/70 mmHg.Then he was treated with vitamin B1 and other medicines.A few days later,his papilloedema subsided,but his blurred vision did not improve.
  • 药源性疾病
    WEN Jian-bo;LEI Zhao-bao
    . 2012, 14(5): 290-4.
    Clinical manifestations of drug-induced microscopic colitis (DIMC) are mainly chronic (continuous or intermittent) non-bloody watery diarrhea, a normal or almost normal endoscopic examination, and special histopathological characteristics. The drugs which cause DIMC mainly include nonsteroidal anti-inflammatory drugs, proton pump inhibitors, selective serotonin reuptake inhibitors, and others. The mechanism is associated with abnormal immunization. Risk factors for DIMC are middle-aged and elderly people, female, and combination therapy. The measures for treatment and prevention are as follows: the causative drugs should be discontinued; the patients with mild symptoms of DIMC could be treated with loperamide; the patients with severe symptoms of DIMC could be treated with budesonide; if drug treatment is ineffective, patients might undergo surgery; the drugs known to induce DIMC should be used with caution in patients with allergic diathesis, autoimmune disease, and allergic disease.
  • 调查研究
    Xiong Fengzhen
    . 2002, 4(3): 154-156.
    Objective: To understand ADR induced by calcium antagonists. Method: Medical literature was retrieved from Chinese Pharmaceutical Abstracts (1992-1999) including 113 articles of 30 journals for ADR occurrence after calcium antagonist treatment. Results: Among 7 calcium antagonists causing ADR in 166 cases nifedipine came first (62 cases, accounting for 37.35% ), followed by flunarizine (51 cases, 30.72%) and nimodipine (20 cases, 12.05%) .ADR of 48 cases (28.92%) located in central nervous system, then 26 cases (15.66% ) in cardiovascular system, and 21 cases (12.65% ) in skin. Except for 2 deaths, 164 cases all recovered after discontinuation of the calcium antagonists and start of the expectant treatment .112 cases ( 67.5 % ) were the elderly over 50. Conclusion: Most of elderly patients suffering from cardio - cerebro - vascular diseases were susceptible to calcium antagonists and should be put in close attention clinically with the adjusted doses.
  • 药物警戒
    . 2002, 4(1): 14-19.
    由于市场效益和临床需求的驱动,对新药的结构修饰或新化学单体的开发异常迅猛。但鉴于新药上市审批程序的缺陷和生产前临床试验病例数量的限制,近年来为数不少的新药相继被发现有严重的不良反应而退出市场,上市和撤出货架的间隔周期也日趋缩短。因此,临床医师和药师应慎重地选择和合理应用新药。另对新药评价和上市后监测的模式也尚待我们思考。
  • 病例报告
    Li Mianshana;Liang Shuwenb;Liu Ganga;Feng Ruijuanc
    . 2008, 10(2): 115-1.

    A 40yearold man with pulmonary infection developed mild tinnitus after intravenous infusion of clindamycin phosphate 600 mg. Six hours later, he received the second infusion of clindamycin, his tinnitus reappeared accompanied with nausea and vomiting, and then aggravated tinnitus and lightning pain in the left face occurred. The pain repeated up to 10 times or more and lasted for several seconds to two minutes, and trigeminal neuralgia was diagnosed. Clindamycin was discontinued. Twelve hours later, his symptoms were relieved.

  • 病例报告
    . 2004, 6(5): 333-334.
  • 安全用药
    . 2004, 6(5): 315-317.
    合理应用药物的副作用为人类造福,使患者也能从廉价的老药获得新的治疗作用。本文介绍了红霉素、氨基糖苷类、西咪替丁、谷维素、卡托普利的副作用在治疗中的良好效果,可供临床参考。
  • 调查研究
    Guo Daihong①;Liu Guiyang①;Wei Xin②;Liu Jing②;Wang Xiang②
    . 2004, 6(2): 88-91.
    Objective:To understand current use of drugs for inpatients.Met ho d:Prescription Automatic Screening System(PASS)was used for investigation of possible drug interactions.Results:7314prescriptions of1207inpatients were analysed,and739drugs were involved in total,6drugs per prescription o n average.The frequency of drug administration was as follows in order:drugs regulating water and electrolytes,cardiovascular drugs,antimicrobials,gastro-intestinal drugs,hormones,drugs affecting the blood,vitamins and minerals. There were drug-drug interactions in204cases and drug-food ones in235cas es.The incidence of adverse reactions were3%,22.8%and42.62%respec tively for1-4,5-9and over10drugs in combined use.Conclusion:In order to avoid adverse reactions the prescribing should follow the principle of ration al drug use,and the number of the drugs should be prescribed as few as possible .
  • Quan Rui, Li Shuwen, Weng Xisheng, Li Na, Chen Weiheng
    Adverse Drug Reactions Journal. 2023, 25(5): 276-280. https://doi.org/10.3760/cma.j.cn114015-20221019-00964
    Objective To investigate the safety of Tenghuang Jiangu tablets in the treatment of knee osteoarthritis. Methods Medical records of knee arthritis patients who used Tenghuang Jiangu tablets in 43-hospitals from September 2019 to January 2021 were collected and the incidence, clinical manifestations, severity and outcome of adverse events were descriptively analyzed. Results A total of 2-505 patients were entered in the analysis, including 788 males (31.46%) and 1-717 females (68.54%), with ages of 50-76 years and a median age of 61 years. The duration of medication was (57±3) days. Among the 2-505 patients, 1-949 cases (77.80%) received the drug twice daily, 553 (22.08%) thrice daily, and 3 (0.12%) once daily; 79(3.15%) patients developed 82 adverse events during Tenghuang Jiangu tablets treatment, including 39 cases of adverse events of digestive system (42 times), 8 cases of systemic adverse events, 6 cases of infectious adverse events, 6 cases of skin and mucous membrane adverse events, 5 cases of neurological adverse events, 4 cases of respiratory system adverse events, 3 cases of eye organ adverse events, 3 cases of cardiac organoid adverse events, 3 cases of injury adverse events, and 2 cases of reproductive system and breast adverse events. A causal evaluation was conducted on the above-mentioned adverse events, with only one case evaluated as possible and the rest as suspicious. Only one patient stopped using Tenghuang Jiangu tablets after an adverse event occurred, while the other patients did not stop the medication, and all patients returned to normal after untreated or symptomatic treatments. Conclusions The incidence of adverse events in the treatment of knee osteoarthritis with Tenghuang Jiangu tablets is 3.15%. Common adverse events include digestive system adverse events, systemic adverse events, infectious adverse events, skin and mucous membrane adverse events, and neurological adverse events.
  • 调查研究
    Zhou Shan
    . 2004, 6(6): 378-380.
    Objective: To investigate the causative drugs and clinical manifestations of drug-induced dyskinesia. Methods: Drug-induced dyskinesia occurred in 96 children during their hospitalization between January 1999 and December 2003, and was retrospectively analysed. Results: The causative drugs were metoclopramide,chlorpromazine,levamisole and haloperidol in this survey. 89 of 96 cases were acute dystonias and 7 were parkinsonism.On withdrawal of the drugs and start of expectant treatment,the symptoms were soon resolved. Conclusion: Dosage of above causative drugs should be strictly controlled for children.
  • 中药不良反应
    . 2006, 8(5): 389-390.
  • 安全用药
    Wang Guishuang;Cai Haodong
    . 2010, 12(1): 31-6.
    Adefovir dipivoxil and tenofovir are nucleotide analogue used for treatment of hepatitis B and other viral diseases. Recently, it has been reported that these two drugs have nephrotoxicity. Adefovir dipivoxil or tenofovirassociated nephrotoxicity is defined as an increase ≥0.5mg/dL from baseline in serum creatinine or a serum phosphorus value of <1.5 mg/dL on two consecutive laboratory tests. The incidence of adefovir dipivoxilassociated nephrotoxicity was doserelated; it is 22%~50% at dose ≥ 30 mg daily, and is similar to the placebo at dose 10 mg daily. The incidence of tenofovirassociated nephrotoxicity was markedly lower than that of adefovir dipivoxil. The severity of nephrotoxicity in most patients is relatively mild. The mechanism of nephrotoxicity may be associated with toxicity of these two drugs to mitochondria. The pathologic changes resulted from nephrotoxicity were mainly extensive edema of epithelium in proximal convoluted tubule, cellular necrosis and vacuolization. The preventive measures are as follows: the renal function and serum phosphorus levels should be monitored regularly during drug therapy; concomitant use of nephrotoxic drugs should be avoided; the drug dosage should be adjusted according to creatinine clearance rate.
  • 论著
    GUO Chao;YANG Cheng-liang;LI Xin-he;YANG Zhu-liang;XIE Li-jing
    . 2013, 15(1): 22-5.

    ObjectiveTo report the epidemiological investigation of a poisonous mushroom poisoning event occurring in Tengchong County, Yunnan Province in order to provide reference for preventing and controlling similar poisonous mushroom poisoning.MethodsAfter receiving the report of poisoning event, the specialists in local Center for Disease Control and Prevention (CDC) hastened to the scene and they conducted epidemiological investigations, identification of poison and analysis of the results.ResultsAround 3 o′clock in the afternoon on June 30,2012, six members of a family comprising a grandfather (case 1, 56-year-old), a grandmother (case 2, 47-year-old), and four granddaughters (case 3, 4, 5, and 6 aged 8, 8, 7, and 1.5 years, respectively) ate a dish containing “malijun” for lunch, which was picked by the grandfather at that day. Around 4-6 o′clock the next morning, two granddaughters (cases 3 and 5) and the grandparents developed nausea, vomiting, and diarrhea successively and then presented to a local health center. They were treated with symptomatic therapy and then returned home. Case 4 experienced diarrhea only without seeking medical advice and case 6 just drank a little juice of the dish and she had no marked symptoms. On July 2, cases 3 and 5 developed lethargy and coma. All the six patients presented to the People′s Hospital of Tengchong County and were diagnosed with group poisonous mushroom poisoning which was reported to local CDC. Case 3 died despite resuscitation attempts in the emergency department. Case 1 was admitted to hospital and case 2 was staying treatment in emergency department and both of them recovered on days 26 and 19 after poisoning, respectively. The other three kids were transferred to provincial medical institutions in the same day and recovered on days 10 to 13 after poisoning. The fresh sample of “malijun”, which was picked by specialists of CDC at the location, was identified as Galerina sulciceps rather than the edible mushroom Laccaria vinaceoavellanea which was commonly called “malijun” by local people. This event was determined as a sudden acute poisonous mushroom poisoning event caused by picking and eating Galerina sulciceps by mistaken.ConclusionsThe appearance of Galerina sulciceps may be easily confused with that of Laccaria vinaceoavellanea, thus, the poisoning may occur due to picking and eating by mistaken. Management of the information on poisoning should be enhanced, and the spectrum of poisonous mushrooms in different districts should be controlled by professional institutes. Medical staff should be trained to reinforce knowledge of diagnosis and treatment of poisonous mushrooms, and popular science education in the prevention of common poisonous mushrooms poisoning to general public should be conducted.

  • 调查研究
    Lv YuanCui HongLiu Jian
    . 2010, 12(3): 169-6.
    Objective: To assess the efficacy and adverse reactions of homemade pazufloxacin and levofloxacin for treating bacterial infections of the respiratory and urinary systems. Methods: Searching CNKI database from 1993 to 2008,the published domestic literature focusing on randomized controlled trials of pazufloxacin and levofloxacin therapy for bacterial infections of the respiratory and urinary systems were collected. According to the criteria for entering, the literature was strictly selected and the quality of selected literature was assessed based on the demand of a metaanalysis. And its results were analyzed by Revman 5.0 and Stata 10.0 software. The odds ratio (OR), 95% confidence interval (95%CI) , and P value of clinical cure rate, response rate, bacterial clearance rate, and the incidence of adverse reactions of homemade pazufloxacin and levofloxacin for treating bacterial infections of the respiratory and urinary systems were calculated. Results: Ten randomized controlled trials from 2005 to 2008 were selected. A total of 1 974 patients entered the trials. Of them, 982 patients were in the pazufloxacin group, 992 patients were in the levofloxacin group. The metaanalysis revealed the following results: the clinical cure rates in the homemade pazufloxacin and levofloxacin groups for treating bacterial infections of the respiratory and urinary systems were 66.6% and 65.7%, respectively; the response rates were 92.3% and 91.5%, respectively; the bacterial clearance rates were 95.1% and 93.3%, respectively; the incidence of adverse reaction rates were 12.5% and 12.9%, respectively; their pooled OR were 1.05(95% CI 0.86-1.27,P=0.650), 1.10 (95% CI 0.79-1.53, P=0.560), 1.45 (95% CI 0.932.27, P=0.100), and 0.97 (95% CI 0.74-1.26, P=0.810),respectively. The differences were no significance. Conclusion: The efficacy and adverse reactions of the homemade pazufloxacin therapy for bacterial infections of respiratory and urinary system are similar to those of levofloxacin.
  • 调查研究
    Yao Linqing;Fang Juanjuan
    . 2000, 2(1): 31-34.
    Objective: To find out the causes, incidence and resulting risks of drug-induced diseases. Methods: 165 patients with drug-induced diseases were admitted to hospital during Jan. 1994Oct. 1999 and their data analysed. Results: The increasing incidence of drug-induced diseases was demonstrated because of the non-standard and irrational drug administration. The causing medications in proper order were antimicrobial agents, antipyretic-analgesics and Chinese medicine. Conclusion: The drug-induced diseases can be reduced through some measures taken, such as drug-use guidance, knowledge updating among medical personnel and so on.
  • Liu Shuo, Kang Wanli, Xu Rui, Zhang Jing, Mao Xinfeng, Cheng Kai
    Adverse Drug Reactions Journal. 2020, 22(12): 665-669. https://doi.org/10.3760/cma.j.cn114015-20191225-01067
    Objective To analyze the influencing factors of the degree of increase in serum uric acid in patients with hyperuricemia related to pyrazinamide. Methods The National ADR Monitoring Information Network System was searched and the adverse reaction reports of hyperuricemia induced by pyra- zinamide that were reported from January 2012 to June 2019 in Beijing Chest Hospital, Capital Medical University were collected. The patients′ gender, age, height, weight, history of drug allergy, antituberculosis therapy, time of pyrazinamide treatment, and serum uric acid level before and after the treatment were recorded. Linear regression method was used to analyze the influence of the above factors on the degree of increase in serum uric acid, which was expressed by the change rate of serum uric acid. Results A total of 177 patients were enrolled in the study, including 124 males and 53 females; their ages were from 15 to 82 years, with a median age of 33 (23, 54) years; their body weight was (60±12) kg, in which 34 cases (19.2%) were <50-kg, 123 cases (69.5%) were 50-75-kg, and 20 cases (11.3%) were >75-kg; their height was (170±8) cm. Among the 177 patients, 143 cases (80.8%) received first-line regimen and 34 cases (19.2%) received second-line regimen; the time of pyrazinamide treatment was 1 to 97 days, with a median time of 8 (6, 11) days; 33 cases (18.6%) had history of drug allergy. The baseline uric acid level in 177 patients was (288±72) μmol/L before pyrazinamide administration and (640±105) μmol/L when hyperuricemia occurred. The change rate of serum uric acid was (139±82)%. Univariate linear regression analysis showed that body weight was negatively correlated with the change rate of serum uric acid (r=-1.343, t=-2.660, P=0.009). The difference in the change rate of serum uric acid among patients with different body weight was statistically significant (χ2=6.977, P=0.031). The difference in the change rate of serum uric acid between the <50-kg group and the >75-kg group was statistically significant (Z=-2.544, P=0.011). Conclusions Body weight is an independent influencing factor for the degree of increase in serum uric acid in patients with hyperuricemia related to pyrazinamide. The change rate of serum uric acid in hyperuricemia patients with lower body weight is higher.
  • Adverse Drug Reactions Journal. 2020, 22(1): 1-1. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.01.001
  • 病例报告
    . 2007, 9(1): 42-42.
  • 临床论著
    Fan Yan;Bai Nan;Wang Rui*;Song Xiu-jie;Liang Beibei;Li Ran;Li Yulian;Cai Yun;Chai Dong
    . 2009, 11(6): 386-5.
    Objective: To evaluate the safety and tolerance of continuous intravenous infusions of caderofloxacin lactate injection in Chinese healthy adult volunteers. Methods:In AprilJuly 2009, 12 healthy adult volunteers were selected and enrolled in the study. They comprised 6 men and 6 women aged 25~35 years [average(31.8±2.8) years]. Their body mass index was 19.8~24.1(22.2±1.3)kg/m2. Caderofloxacin lactate 400 mg/2 h was infused intravenously at a constant rate once daily for 7 days. The subjects’vital signs and adverse events were observed and recorded. The routine blood and urine tests as well as biochemical tests were performed. The intensive monitoring for the changes in the QT interval and corrected QT(QTc) interval one hour before drug initiation and 3 and 6 hours after drug initiation as well as OGTT on days 3, 5, and 8 after drug initiation were performed. Results: Eleven subjects completed a 7day continuous infusions but one woman stopped her infusion due to menstruation on day 3. The subjects’ body temperature, pulse, respiratory rate and blood pressure and other vital signs were within the normal range after drug administration. A total of 7 cases of adverse events occurring included 5 cases of slightly increased triglyceride levels, one case of slightly increased total protein levels, one case of transient low blood glucose level(2.96 mmol/L). The 7 adverse events may not have a causal relationship with the drug in the analysis. On days 2, 5, and 8 after drug initiation, one subjects’WBC count (2.75×109/L, 3.07×109/L, and 2.95×109/L, respectively) and neutrophil count (0.39, 0.33, and 0.39, respectively) were lower than the normal limits, but both normalized 2 days after drug discontinuation. The events may be associated with the drug. On 7 successive days after drug initiation, the difference in a certain level of AST, TB, and urea among the days was statistically significant (all P<0.05), but there was no clinical significance. On days 2, 3, 4, and 7 after drug initiation, the QT interval prolonged compared with before drug administration, but the QT interval was <450 ms. No abnormal changes in clinical significance were seen. On day 5 after drug initiation, 11 subjects’ fasting blood glucose level was (4.21±0.35)mmol/L, which was lower than that [(4.74±0.59)mmol/L] 1 day before drug administration. On days 3 and 5, 11 subjects’ blood glucose levels one hour after meal was (6.20±1.58), (6.07±1.19) mmol/L, which were lower than that [(8.47±2.51) mmol/L)] one day before drug administration. Although the difference was statistically significant (P<0.05), but there was no clinical significance. Other routine blood and urine tests as well as biochemical tests revealed no marked changes before and after drug administration. Conclusion: Continuous intravenous infusions of caderofloxacin lactate injection exhibit good tolerance and safety
  • 病例报告
    Zhou Meizhen;He Chengsong
    . 2007, 9(6): 432-432.
    A 94-year-old man with rectal adenocarcinoma received capecitabine chemotherapy.In cycle 3,capecitabine 1500 mg twice daily was given.Twelve days after the administration of capecitabine,he developed drowsiness,palpitation,and a fever.His SCr increased from 145 μmol/L to 173 μmol/L,and BUN increased from 10.9 mmol/L to 27.4 mmol/L.Capecitabine was discontinued immediately.Six days later,his SCr and BUN rose to 310 μmol/L and 62.5 mmol/L,respectively.He was given compound α-keto acid,diuretics,and low protein diet.Then his SCr and BUN gradually decreased.At follow-up 4 months later,his levels of SCr and BUN normalized.
  • 论著
    FU Dong;LI Zhen-hua;LIU Min;CAI Hao-dong
    . 2012, 14(3): 149-5.
    ObjectiveTo explore the influence of antiviral therapy on pregnancy outcome in active hepatitis B patients during pregnancy. Methods The patients, who were in 8-24 weeks of pregnancy and had abnormal liver function [alanine aminotransferase (ALT) ≥3×upper limit of normal] and HBV DNA level ≥5 lg copies/ml in the department of gynaecology and obstetrics, Beijing Ditan Hospital, Capital Medical University from August 2006 to April 2011, were selected. According to the patients’will, they were divided into the antiviral treatment group receiving lamivudine or telbivudine and the liver-protective treatment group receiving polyene phosphatidyl choline, adenosylmethionine, glutathione, Ganxile (肝喜乐) tablets and Ligankang (利肝康) tablets etc. The liver disease outcome during pregnancy, severe adverse events and neonates’outcome in the 2 groups were compared. ResultsA total of 102 patients were entered in this study. Of them, 56 patients were in the antiviral treatment group and 46 patients were in the liver-protective treatment group. There were no statistically significant differences in baseline characteristics of patients between the 2 groups (P>0.05). Fifty-three patients completed pregnancy and 3 patients lost from follow-up in the antiviral treatment group. Thirty-seven patients completed pregnancy in the liver-protective treatment group. Of the other 9 patients, 5 patients lost from follow-up, 2 selected artificial termination of pregnancy, and 2 patients’pregnancy failed. The rate of ALT levels returning to normal [90.6% (48 patients)] and the rate of HBV DNA levels changing to negative [58.5% (31 patients)] before delivery in the patients in the antiviral treatment group were higher than those [18.9% (7 patients), 8.1% (3 patients)] in the liver-protective treatment group (P=0.000 for all comparisons). The rates of natural or artificial termination of pregnancy (0) and non-birth-related hospitalization [7.5% (4 patients)] in the patients in the antiviral treatment group were markedly lowered than those [9.8% (4 patients), 26.3% (10 patients)] in the liver-protective treatment group (P=0.020, P=0.023). There were no significant differences in the rate of hospitalization due to abnormal liver function between the 2 groups (P=0.061). Of the 53 neonates in the antiviral treatment group, 46 completed the whole course of immunization and no neonate failed; of the 37 neonates in the liver-protective treatment group, 30 completed the whole course of immunization and 3 neonates (10.0%) were HBsAg-positive. The difference in the blocking rates of mother-to-child transmission in the neonates between the 2 groups was statistically significant (P=0.029). ConclusionLamivudine or telbivudine treatment used in active hepatitis B patients during pregnancy is safe and effective for mother and fetus. The treatment could inhibit effectively HBV replication, decrease ALT levels, and reduce the risk of HBV mother-to-child transmission.
  • 病例报告
    Yang Qing;Li Fan;Hu Bing
    . 2011, 13(4): 247-3.

    A 7-year-old girl received an IV infusion of cefathiamidine 2.0 g in 0.9% sodium chloride 100 ml once daily and an IV infusion of mezlocillin 2.0 g dissolved in 0.5% glucose 100 ml once daily for nine days for preventing infection after surgery. On day 2 after withdrawl, the patient developed generalized pruritus accompanied by sporadic rashes and low-grade fever. Subsequently, her rash progressively worsen and became purple and more extensive; vesicles with erosion were seen on the lesion surface; the rash mainly involved her trunk, and erosion and purulent exudation were noted in the oral and conjunctival mucosa. She was then hospitalised and treated with azithromycin, fusidic acid, methylprednisolone, human immunoglobulin, and drugs for external use. Her symptoms of skin improved gradually and, two weeks later, she recovered and was discharged.

  • ADR监测
    . 2004, 6(5): 342-344.
  • 病例报告
    Yang Xinyun;Xiao Xianglin;Xiao Liting
    . 2009, 11(4): 278-2.
    A 83yearold man with chronic obstructive pulmonary disease and pulmonary heart disease complicated with infection received an IV infusion of ciprofloxacin 400 mg once daily and an IV infusion of methylprednisolone 40 mg twice daily. The next day, the patient developed agitation and hyperemotion. Ciprofloxacin was discontinued and the dosage of methylprednisolone was decreased to 40 mg once daily, and the patient's mental status slightly improved. On day 6, the abnormal mental status and abnormal behavior reappeared in the patient; he had delusion of persecution and behavior of selfmutilation. Pulmonary encephalopathy and theophylline poisoning were excluded. Abnormal mental symptoms were considered to be possibly methylprednisoloneassociated. Methylprednisolone was discontinued and switched to oral prednisone. His mental status gradually improved.
  • 病例报告
    Chen Yanmei;Wu Yuntao
    . 2008, 10(3): 207-1.

    An 89yearold man with type Ⅱ diabetes mellitus and hypertension was hospitalized with pulmonary infection. The hypoglycemia and antihypertensive agents were discontinued, and he was infused with pazufloxacin 0.3 g twice daily intravenously. After one hour of the third infusion of pazufloxacin, the patient developed a cold sweat, and his blood glucose level decreased from 10 mmol/L to 2.7 mmol/L. Pazufloxacin was discontinued immediately, and he received intravenous injection of 60 ml of glucose 50%, intravenous infusion of glucose 10%, and sufficient foods. Twentyfour hours later, his blood glucose increased to 5.6 mmol/L gradually.

  • 病例报告
    . 2000, 2(4): 263-263.
  • ADR监测
    . 1999, 1(2): 108-111.
    主要介绍第二军医大学长海医院ADR监察工作的发展过程,如何在工作中不断完善医院ADR监察的组织机构,制定可行的工作程序,提高医务人员对监察工作的认识,使ADR监察成为医院的常规工作之一。通过对ADR的分析,研究预防ADR的措施,从而减少或减轻ADR的发生,提高药物治疗水平。
  • 专家论坛
    . 2012, 14(1): 1-3.
  • WANG Jia-yu;LI Qing;ZHANG Pin;YUAN Peng;MA Fei;CAI Rui-gang;LUO Yang;FAN Ying;LI Qiao;XU Bing-he
    . 2013, 15(3): 123-5.

    ObjectiveTo determine the effect and influence factors of amenorrhea due to adjuvant chemotherapies of anthracycline-based and anthracycline followed by taxen in premenopausal patients with early breast cancer.MethodsCase records of the patients who were premenopausal and estrogen receptor-positive with early breast cancer and received adjuvant chemotherapies of anthracycline-based and anthracycline followed by taxen in Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College from 2008 to 2010 were collected and retrospectively analysed. The chemotherapy regimens included anthracycline-based regimen 6EC (epirubicin 75 mg/m2 and cyclophosphamide 600 mg/m2 for 6 cycles and each cycle taking 21 days ) and the anthracycline followed by taxen regimen 4EC-4T ( epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 for 4 cycles and each cycle taking 21 days, followed by paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 for 4 cycles and each cycle taking 21 days). The patients were divided into two groups by the regiments. The incidence of chemotherapy-induced amenorrhea (CIA) was calculated and the recovery situation of menses and ovarian function in the patients with CIA during two years after the end of chemotherapy was recorded. The ovarian function was showed by luteinizing hormone, follicle-stimulating hormone, and estradiol levels. Influence factors of CIA was analysed in Logistic regression and χ2 test methods. ResultsNinety-six patients were enrolled in this study. Of them, 45 patients were in the 6EC group with a media age of 43-year-old and 51 patients were in the 4EC-4T group with a media age of 42-year-old. Seventy-seven of ninety-six patients (80.2%) suffered from CIA during two years after the end of chemotherapy. Of the 77 patients with CIA, 51 patients′menses(66.2%) normalized and 53 patients′ovarian function(68.8%) normalized during the two years after the end of chemotherapy. There were no statistical differences in the CIA incidence, the rate of recovery of menses, and the rate of recovery of ovarian function between the 4EC-4T and the 6EC groups [75.6% (34/45) vs. 84.3% (43/51), 70.6% (24/34) vs. 62.8% (27/43), 73.5% (25/34) vs. 65.1% (28/43), P>005 for all the comparisons]. Age was an important influence factor of outcome of CIA [P=0.048, hazard ratio=0.759, 95% confidence interval (0.448, 0.968)]. The incidences of CIA and the rates of recovery of ovarian function in the patients aged >40 years and the patients aged ≤40 years were 86.9% (53/61) vs. 686% (24/35), 56.6% (30/53) vs. 100.0% (24/24) respectively,(P=0.022, P=0.000). The time of menses recovery synchronized with the time of ovarian function recovery in the patients aged ≤40 years and the time of menses recovery (a median time of 11 months) was later than the time of ovarian function recovery ( a median time of 9 months ) in the patients aged >40 years.ConclusionsBoth anthracycline-based and anthracycline followed by taxen regiments can induce CIA in the premenopausal patients with early breast cancer and the incidence and outcome of the two groups are similar. Age is an important influence factor of the incidence and outcome of CIA. The choice of endocrinotherapy after postoperation chemotherapy for the younger patients with CIA should be careful.

  • 病例报告
    Zhou Yue;Xiao Hui;Luo Min
    . 2007, 9(6): 431-431.
    A 69-year-old woman was hospitalized with posterior-circulation ischemia.She was given intraveous infusion of edaravone 30 mg twice daily.She felt palpitation and chest distress after the first infusion in the morning,and the symptoms were aggravated after the second infusion in the afternoon.Her BP was 130/70 mmHg,and heart rate was 70 beats/min.Premature beats were 2 to 3 times/min.A 24-hour Holter-ECG monitoring showed sinus arrhythmia,frequent ventricular premature beat,and non-sustained ventricular tachycardia.Edaravone was stopped,and oral amiodarone 0.2 g thrice daily was given.Twelve days later,the symptoms disappeared.An ECG re-examination was normal.
  • Luo Aijing, Liu Juan, Huang Lingjin, Hu Qinghua, Luo Wanjun, Chen Xuliang
    Adverse Drug Reactions Journal. 2020, 22(8): 455-459. https://doi.org/10.3760/cma.j.cn114015-20191210-01002
    Objective To explore the effect of network medication guidance on anticoagulation management of warfarin. Methods The study was designed as the retrospective cohort study. Study subjects were selected from patients who underwent cardiac valve replacement during January 2018 and April 2019 in the Department of Cardiovascular Surgery of Xiangya Hospital, Central South University, and took oral warfarin for 3 months or more after operation. According to the mode of revisit, the patients were divided into 4 groups: 1-month post-operation network group (INR review results were uploaded online for more than 2 times within 1 month after operation), 1-month post-operation control group (INR was reviewed in Xiangya Hospital 1 month after the operation and INR data was recorded), 3-month post-operation network group (INR review results were uploaded online for more than 4 times within 3 months after operation), and 3-month post-operation control group (INR was reviewed in Xiangya Hospital 3 months after the operation and INR data was recorded). The gender and age distribution of patients in the network group and the control group, as well as INR and INR compliance rate at 1 or 3 months after operation were compared. Results A total of 420 patients underwent cardiac valve replacement in Xiangya Hospital during the study period, and all of them were prescribed warfarin for anticoagulation. Among the 420 patients, 266 patients (63.3%) had network or Xiangya Hospital revisit records 1 month after operation, 71 of which were included in the 1-month post-operation network group and 178 of which in the 1-month post-operation control group; 132 (31.4%) patients had network or Xiangya Hospital revisit records 3 month after operation, 46 of which were included in the 3-month post-operation network group and 77 of which in the 3-month post-operation control group. Patients in the 1-month post-operation network group had lower age, higher INR compliance rate, and lower incidence of insufficient anticoagulation than those in the 1-month post-operation control group, and the differences were all statistically significant [(49±10) years vs. (53±11) years, P=0.009; 64.8%(46/71) vs. 45.5%(81/178), P=0.006; 21.1%(15/71) vs. 46.6%(83/178), P<0.001]. Patients in the 3-month post-operation network group had higher INR, higher INR compliance rate, and lower incidence of insufficient anticoagulation than those in the 3-month post-operation control group, and the differences were all statistically significant [(2.05±0.45) vs. (1.84±0.62), P=0.044; 67.4% (31/46) vs. 30.9% (30/97), P=0.002; 30.4% (14/46) vs. 54.5% (42/77), P=0.009]. Conclusions Network medication guidance is helpful to improve the effect of warfarin anticoagulation management and improve the INR compliance rate of patients after cardiac valve replacement. The main manifestation of substandard anticoagulation is insufficient anticoagulation, which should be paid attention to.
  • He Cuiyao, Liu Chengjun, Jia Yuntao, Lyu Fengjun
    . 2016, 18(1): 60.
    A 2 months and 14 day old boy was hospitalized for drug eruptions and pneumonia. He received an IV infusion of fluconazole 24 mg twice daily because of Candida albicans positive in sputum culture, and plasma 1-3-beta-D dextran 324 ng/L during the processes of anti-infection and anti-allergic treatment. The boy′s liver function was normal and the abdominal ultrasound examination had no abnormality seen before taking fluconazole. On day 5 after administration of fluconazole, the boy developed new rash on the mouth and lower limbs, moderate xanthochromia, pitting edema of skin over the whole body, and obvious abdominal distension after eating foods. Laboratory test showed alanine aminotransferase (ALT) 579 U/L, aspartate aminotransferase (AST) 655 U/L, total bilirubin (TBil) 71.9 μmol/L, direct bilirubin direct(DBil) 48.7 μmol/L, and alkaline phosphatase (ALP) 89 U/L on day 6 after administration of fluconazole. Ultrasound examination showed hepatomegaly and strong echo of strip in right hepatic lobe. On day 7, fluconazole was replaced by IV infusion of voriconazole 28 mg diluted in 5% glucose 15 ml twice daily. On the second day of using voriconazole, laboratory tests revealed the following results: ALT 761 U/L, AST 717 U/L, TBil 132.3μmol/L, DBil 112.4 μmol/L, ALP 104 U/L, prothrombin time 57 s, partially activated prothrombin 88 s, international normalized ratio 4.86, blood ammonia 79 μmol/L and lactic acid 6.5mmol/L. The patient was diagnosed as liver failure. Voriconazole was stopped. The boy received the symptomatic treatments which including liver-protecting and cholagogue agents, reducing blood ammonia, supplying coagulation factors, and 2 times of plasmapheresis. The boy was suggested to consider liver transplantation, because of his liver function had no significant improvement during the 5 days′ treatment. His parents gave up the treatment and discharged by themselves. The boy was died on the second day of discharging which known from follow-up.
  • Wang Peng, Hu Yong
    . 2016, 18(3): 194.
    ObjectiveTo analyze the characteristics of bleeding caused by ticagrelor and provide reference for clinical medication safety.MethodsNational Adverse Drug Reaction Monitoring System was searched and adverse drug reaction reports on bleeding induced by ticagrelor from January 2013 to December 2014 were collected. The patients′ sex, age, primary disease, manifestations of bleeding, evaluation of causality were analyzed. Ttreatment and outcome were recorded.ResultsA total of 36 patients with bleeding were entered in this study. Of them, 26 patients were males, 7 were females, and sex of 3 were not clear; their ages were 40-113 years. The primary diseases of bleeding were acute coronary syndrome (ACS) in 20 patients, ACS combined with coronary heart disease in 5 patients, coronary heart disease and coronary heart disease combined with other diseases in 7 patients, and other diseases in 4 patients. The percentages of patients with gastrointestinal bleeding and intracranial hemorrhage induced by ticagrelor were 54.6% (20/36) and 19.4% (7/36), respectively. Of the 25 patients who were treated with ticagrelor and aspirin, 18 patients developed gastrointestinal bleeding and 7 patients developed intracranial hemorrhage. Of the 36 patients with bleeding, 17 patients were cured, 8 were improved, 2 were not improved, 3 died, and 6 were not clear.ConclusionsFatal/life-threatening bleeding (gastrointestinal bleeding, intracranial hemorrhage) induced by ticagrelor accounted for large proportion and was mainly serious bleeding. However, most patients with bleeding induced by ticagrelor could recover or improve after treatments.
  • Wang Tailing, Wang Guiqiang
    . 2015, 17(4): 315.
    A 36-year-old woman developed fatigue, anorexia, and yellowish skin after taking Paiduyangyan capsule by herself for a month. Liver function tests showed the following results: alanine aminotransferase (ALT) 1 032 U/L, aspartate aminotransferase (AST) 602 U/L, total bilirubin (TBil) 61.7 μmol/L, direct bilirubin (DBil) 45 μmol/L,  γ-glutamyl transferase (γ-GT) 148 U/L, alkaline phosphatase (ALP) 140 U/L. Paidugangyan capsule was stopped and liver-protective treatments were given but there were no marked treatment effects. The levels of above mentioned parameters increased continuously and anti nuclear antibody (ANA) level increased one month after the onset of the liver injury. The highest titer of ANA was >1 ∶  1 000. Liver biopsy result suggested that the liver injury was caused by drugs. Four and a half months after the onset of liver injury, the patient received prednisolone (initial dose was 60 mg once daily and then the dose was gradually reduced). After 3 months of prednisolone treatment, the patient′s liver function parameters returned to normal. After 7 months of prednisolone treatment, the patient′s ANA level returned to normal and all symptoms disappeared. After 7 and a half months of treatment, prednisolone was stopped. The symptoms did not recur at 7 years of follow-up.
  • Lan Yu;Liu Xiao
    Adverse Drug Reactions Journal. 2009, 11(5): 369-1.
    A 63-year-old woman with asthma received salmeterolfluticasone propionate dry powder for inhalation. The dose was two inhalations of salmeterol 50 μg and fluticasone 250 μg twice daily. Fourteen months later, the patient developed foreign body sensation on swallowing. The durg was continuing and 2 allitride enteric-coated tablets thrice daily was given. Fourteen days later, his symptoms disappeared.
  • 病例报告
    Man Hui
    . 2007, 9(3): 208-208.
    A 38-year-old woman with onychomycosis was administered with ketoconazole 200mg daily. After two months and a half, she developed anorexia and severe yellowing of the skin and sclera. Laboratory tests revealed the following values: ALT 213.5 U/L, AST 317.5 U/L, Tbil 597.9 μmol/L, Dbil 269 μmol/L, PTA 47.5%. The marks of viral hepatitis were negative. Liver pathological diagnosis was subacute hepatic necrosis. According to the history of taking ketoconazole, drug-induced hepatitis and subacute hepatic necrosis were diagnosed. After symptomatic therapy and pulse methylprednisolon therapy, the woman had an ALT level of 16.4 U/L, a Tbil level of 36.9 μmol/L, and a PTA level of 92%. After 45 days in hospital, she improved obviously and was discharged
  • 安全合理用药
    . 2007, 9(2): 108-111.
    上消化道出血是消化系统常见疾病,因某些药物引起上消化道出血的病例近年来屡见报道,应引起临床工作者的高度重视。本文对几类常见的可引起上消化道出血的药物的种类、发病机制、临床表现和防治等作一概述,以期对临床安全合理用药,减少药物不良反应有所帮助。
  • 中药不良反应
    . 2007, 9(1): 61-61.
  • 调查研究
    Fan Jianrong;Liu Maoshun;Li Yanqin
    . 2000, 2(2): 84-86.
    Objective:To analyse the existing status of dependence caused by the abuse of non-narcotic analgesics. Methods: The outpatients having taken a considerable amount of non-narcotic analgesics were enrolled as our subjects. The patients were followed up with the events recorded, investigated and diagnosed. Results: The abuse of non-narcotic analgesics in most cases proved to be iatrogenic, leading to the drug dependence, which a great attention was being paid to in the community. Conclusion: Extensive publicity and rational use would be the key to reducing the abuse of this kind of drugs.
  • 论著
    Luo Leiming;Chen Minzhi;Shi Jun;Zhang Ling;Yang Xue;Zhu Qiwei
    . 2004, 6(3): 151-154.
    Objective: To evaluate the efficacy and safety of antiarrhythmics for prevention of recurrence of paroxysmal atrial fibrillation(PAF). Methods: Patients with PAF were randomly divided into three groups treated with amiodarone, propafenone and atenolol respectively, and a control group. They were followed up regularly for a year. Results: Low-dose amiodarone and propafenone could reduce recurrence rate of atrial fibrillation and shorten its lasting time and extend the time of sinus rhythm. Amiodarone is better than propafenone in efficacy and both show little difference in adverse effects. Conclusion: Low-dose amiodarone and propafenone could be first-choice drugs to prevent PAF with high safety and low incidence of adverse effects.
  • 综述
    . 2002, 4(2): 73-76.
    他汀类药物能够有效防治急性冠脉综合征,但不能完全用其降脂作用解释。本文对他汀类药物非降脂作用在急性冠脉综合征防治中的作用及其机制进行讨论。他汀类药物减少胆固醇合成的中间产物,通过其抗炎、调节免疫、抑制细胞增殖、改善内皮功能、抑制血栓形成的非降脂作用,在多个环节上干扰或阻断急性冠脉综合征的发病过程。对他汀类药物非降脂作用的认识,有助于这类药物更广泛、更准确的应用。
  • 病例报告
    Zhang Xuxia;Li Hongling
    . 2008, 10(2): 142-2.
    A 37yearold man underwent gallbladder resection was administered IV clindamycin 3 g twice daily after surgery. The following day, the patient developed generalized pain, brown urine with occult blood. Laboratory testing showed the following values: free hemoglobin 196 mg/L, reticulocyta count 0.20, urine hemosiderin (+), TBil 83.32 μmol/L,and IBil 60.2 μmol/L. Acute drug-induced hemolytic anemia was diagnosed. Clindamycin was discontinued, and he was hydrated by infusion of alkaline fluid and given reduced glutathione. One week later, his indices normalised gradually.
  • 病例报告
    Cao Jingjinga;Wang Hujunb
    . 2008, 10(2): 139-2.

    An 82yearold man was hospitalized with coronary heart disease, hypertension, and diabetes. After admission, he was administered with coronary vasodilators, antihypertensive drugs, and hypoglycemia agents. The patient sometimes took estazolam for a poor sleep. Later, estazolam was switched to zolpidem 10 mg at bed time. Three hours later, the patient got up, walked around, raved, and passed urine on the floor. The next day, the symptoms disappeared, and the patient had no memory of that event. Zolpidem was discontinued and estazolan was continued. The symptoms did not reappear.

  • 国外文献题录
    . 2004, 6(5): 348-349.
  • Han Junling;Wu Shuyun
    Adverse Drug Reactions Journal. 2009, 11(6): 385-2.
    A 39yearold man with psoriasis recurrence received acitretin capsules, Qingdai capsules, and compound aminopolypeptide tablets, as well as anthralin ointment for external application. Two months later, the patient developed pain in the hepatic region and abdominal distension. Liver function revealed the following values: ALT 71.0 U/L, AST 42.0 U/L, γGT 90.9 U/L. The abovementioned medicines were stopped and his symptoms were not relieved. Subsequently, repeated blood tests were positive for antinuclear antibody, antimitochondrial antibody, smooth muscle antibody, and liver and renal microsomal antibody. His liver function was abnormal. Liver biopsy was compatible with the pathological changes of druginduced hepatic damage. His liver function tests remained abnormal at follow up after one month.
  • 调查研究
    Song Yan;Zhang Yiyan;Li Jijun;Zhang Liwei;Yao Fenghua;Yin Pei;Chen Fengqun;Li Xueyi
    . 2006, 8(6): 425-428.
    Objective:To analyse the causes of misdiagnosis to Guanxinsuhe pills-related renal injury in order to be benefial to its exact diagnosis and treatment. Methods:Thirty-one cases with Guanxinsuhe pills-related injury were reviewed,and the causes of misdiagnosis to 9 of them were analysed. Results:All of the 9 cases were middle-aged and elderly patients. They were diagnosed as chronic tubulointerstitial nephrothy with renal tubular acidosis,renal glucoseuria,hyposthenuria,and decreased renal function in varying degree. The severity of anemia was not parallel to decreased renal function. Of the 9 patients,7 took Guanxinsuhe pills according to the dosage of pharmacopoeia,and 2 took the dosage higher than that of pharmacopoeia. Of the cases,5 were misdiagnosed as hypertensive nephropathy,2 diabetic nephropathy,and 2 chronic glomerulonephritis. Seven of the 9 patients were not asked about the history of Guanxinsuhe pills use,and 2 patients had the history of Guanxinsuhe pills use but they were not diagnosed as Guanxinsuhe pills-related renal injury. Conclusion:The most of cases with Guanxinsuhe pills-related renal injury are middle-aged and elderly patients. Since clinician are not well aware of renal toxicity and renal injury of Guanxinsuhe pills,the Guanxinsuhe pills-related renal injury of middle-aged and elderly patients with diabetic or hypertension are usually misdiagnosed as diabetic nephropathy or hypertensive nephropathy. Therefore,the patients with renal injury,especially in middle-aged and elderly patients,should be asked about the history of Guanxinsuhe pills use in order to avoid the missed diagnosis or misdiagnosis.
  • 调查研究
    Tao Ye;Yuan Caixia
    . 2000, 2(3): 154-156.
    Objective: To improve the safety of propafenone in treatment of paroxysmal supraventricular tachycardia (PSVT) . Methods: Lanatoside and metaraminol failed in conversion in 23 cases with arrhythmia, who had complication of heart failure or hypotension or shock. Now the above drugs were used alone or in combination followed by propafenone injected. Results: The effective rate of arrhythmia conversion was 91.3% in study groups. No heart failure, hypotension and shock were induced or worsened and no any other serious cardiovascular side-effects were observed. Conclusion: Propafenone still remains an effective and safe drug for PSVT.
  • 调查研究
    Jin Weiqiu;WuPenglan;YangChunyan
    . 2000, 2(1): 23-25.
    Objective: To improve the understanding of drug-induced non-cardiogenic pulmonary edema (DINCPE). Methods: The clinical manifestations of 9 cases with DINCPE were analyzed and its diagnosis and e-mergency treatment discussed. Results: The high cure rate of DINCPE was observed if treatment began at early stage. However, its early diagnosis remained low. Conclusion: Physicians should be familiar with and think of DINCPE when the pulmonary edema is refractory to the traditional inotropic and diuretic therapy , with the corresponding treatment at once.
  • 调查研究
    Zhai Wei①;Zhang Liming②;Yan Wei②;Qin Ying③;Zhan Siyan③;Liang Jianhui④;Cui Yimin②
    . 2007, 9(2): 95-99.
    Objective: To understand the prevalence of psychotropic adyerse event in emergency patients in order to provide scientific basis for the safe use ang control of psychotropic drugs.Methosa:During the period from December 2005 to March 2006,the adverse drug events of emergency patients were investigated by use of a questionnaire in 9 emergency deperyment of general hospitals and 2 emergency medical centres.The adverse events of psychotropic drugs were analysed and compardwith that of non-psychotropic drugs.Results:Of the 339 cases of adverse events,psychotropic adverse events were 241 cases(71.09%),and most of them were non-medical use including suicide(68.46%),drug abuse and drug dependence(2.90%).The psychotropic adverse events were mainly caused by catalog Ⅱ psychotropic drug,and the most common drug was diazepam(33.33%).Compared with the patients receiving non-psychotropic drugs,the patients receiving psychotropic drugs were younger,their dosages,emergency treatment,hospital adnission,and death were significant higher.Conclusion:Psychotropic adverse events are common in emergency patients.Therefore,it is necessary to strengthen the monitoring and prevention strategies.
  • 中药不良反应
    Yang Yiheng;Zhou Yanli
    . 2007, 9(3): 214-215.
    Two patients developed liver dysfunction after treatment with Xianlinggubao capsules for osteoporosis. The first patient, a 65-year-old woman with hypertension and cerebral insufficiency, was treated with Jiangyalinghao and ginkgo biloba leaf tablets. And then her regimen was added to Xianlinggubao capsules 1.5g twice daily. Six months later, laboratory inves- tigations revealed ALT and AST levels of 85 U/L and 93 U/L, respectively. Xianlinggubao capsules were stopped, and Jiangyalinghao and ginkgo biloba leaf tablets were continued. After 20 months of cessation of Xianlinggubao capsules, her ALT and AST levels decreased to 17 U/L and 28 U/L, respectively. The second patient, a 68-year-old woman with atrophic gastritis, was receiving a long-term therapy with cisapride. And then her regimen was added to Xianlinggubao capsules1.5g twice daily. Two months later, laboratory tests showed following values: ALT 158 U/L and AST 123 U/L. Xianlinggubao capsules were discontinued, and cisapride was continued. In addition, the patient was administered with glucurolactone 200 mg thrice daily for 15 days. Approximately 6 months later, her ALT was 35 U/L and AST was 23 U/L.
  • 调查研究
    Han Rui;Duan Jingli;
    . 2010, 12(2): 100-5.
    Objective: To analyze and evaluate the rationality of antibacterial use in patients undergoing oral and maxillofacial surgery in the perioperation period in order to raise the level of rational antibacterial use. Methods: Case records were randomly collected from the 4 037 patients discharged from Peking University Hospital of Stomatology following undergoing oral and maxillofacial surgery during the period from January to December 2009. The patients’sex, age, operation type, and the situation of antibacterial use in the perioperation period were retrospectively investigated and analyzed, and the rationality of antibacterial use was evaluated. Results: A total of 997 case records was colleted. These patients comprised 506 males (50.75%) and 491 females (49.25%) with average age of 31 years. Of them, 167 patients were ≥60 years, 217 patients≤10 years. The patients undergoing clean, cleancontaminated, and contaminated surgeries were 183 cases (18.36%), 806 cases (80.84%), and 8 cases (0.80%), respectively. All patients received antibacterials. Of them, 486 patients (48.75%) received a single antibacterial agent and 511 patients (51.25%) received a combination of two antibacterial agents. The three classes of most commonly used antibacterials were successively penicillins (581 cases, 38.53%), nitroimidazoles (447 cases, 29.64%), and cephalosporins (321 cases, 21.29%). The patients receiving metronidazole combined with penicillin as well as metronidazole combined with cefuroxime were 233 cases (45.6%) and 210 cases (41.1%), respectively. Before surgery, the antibacterials used for prophylaxis were given mainly by intravenous route, but 2 cases by oral route. The timing of antibacterials used for surgical prophylaxis (0.5-2.0 h before surgery) was rational to 979 patients; of them, the patients undergoing clean,cleancontaminated and contaminated surgeries were 181 cases (98.91%), 790 cases (98.01%), and 8 cases (100%), respectively. The timing of antibacterials used for surgical prophylaxis was irrational to 18 patients; of them, fourteen patients received antibacterials <0.5 hours before surgery and four 2.5 hours before surgery. The duration of antibacterial use after surgery was rational or basically rational to 804 patients; of them, the patients undergoing clean, cleancontaminated, and contaminated surgeries were 125 cases (68.31%), 671 cases (83.25%), and 8 cases (100%), respectively. Antibacterial use was irrational in 193 patients; the main problem was prolonged drug use, and the longest was 10 days. In the perioperation period, rational and basically rational antibacterial use were respectively 47 cases (4.71%) and 686 (68.81%), the total was 733 (73.52%). Of them, clean, cleancontaminated, and contaminated surgeries were 121, 605, and 7 cases, respectively. Antibacterial use were irrational in 264 patients (26.48%). Conclusion: The inappropriate antibacterial use in oral and maxillofacial surgery in the perioperation period includes drug use without indication, improper drug selection, improper timing of antibacterials used for surgical prophylaxis, and prolonged use of antibacterials after surgery. Therefore, further implementing the guidelines related to clinical antibacterial use and strengthening the education of appropriate drug use are essential.
  • 安全用药
    ZHAO Wen-yan;ZHANG Jian
    . 2012, 14(5): 294-5.
    Linezolid is an oxazolidinone antibiotic and has potent antibacterial activity against most Gram-positive bacteria. The most common serious adverse reactions caused by linezolid is hematologic toxicity, such as anemia and thrombocytopenia. The possible mechanism of linezolid-associated hematologic toxicity is bone marrow suppression and immune mediation. The risk factors for linezolid-associated hematologic toxicity include advanced age, long-term treatment, lower baseline blood cell counts, hepatorenal dysfunction and so on. The measures of prevention and treatment are as follows: linezolid should be only used for labeled indications; prolonged use of linezolid should be avoided; a combination of linezolid and drugs that cause bone marrow depression should be avoided; linezolid concentrations should be monitored in patients with advanced age and/or severe hepatorenal failure; routine blood tests should be performed during treatment. If cytopenia occur, linezolid should be discontinued immediately, and blood transfusions should be given in patients with severe symptoms.
  • 病例报告
    Ren Xiaolei;He Zhen;Li Yuzhen
    . 2011, 13(3): 182-2.
    A 62-year-old woman presented with cough, expectoration, and fever after receiving amiodarone 300 mg/d for 4 years for atrial fibrillation. A chest CT scan revealed bilateral pulmonary diffuse interstitial infiltrations. Drug-induced interstitial pneumonitis was considered to be related to amiodarone. Amiodarone was discontinued, and prednisone was given. Her condition gradually improved.
  • Du Haiyan, Lin Yang
    . 2015, 17(4): 275.
    Aspirin is an antiplatelet drug with the most abundant evidences of evidence-based medicine, which was used in the primary prevention of cardio and cerebrovascular diseases. It has been controversial on the benefits and the bleeding risks of aspirin for primary prevention of cardio and cerebrovascular diseases. In the present, the evidences mainly come from 9 large scale randomized controlled trials in the world and related Meta-analysis. In recent years, it is tended not to emphasize the role of aspirin for primary prevention in guidelines on cardio and cerebrovascular disease prevention in several countries. It is suggested in Chinese expert consensus on antiplatelet therapy published in 2013 that aspirin is given to the patients with medium and high risks who are decided according to the risks of cardio and cerebrovascular diseases.
  • Xing Yuzhi
    . 2016, 18(1): 68.
    Two female patients (41 and 28 years old, respectively) received an intravenous infusion of cefoxitin sodium for gallstones and cholecystitis. Abdominal pain was relieved after 21 and 7 days of treatments, then the drug was stopped. Two or 3 days after drug withdrawal, pain and swelling appeared in her both forearms, the point of puncture turned red, and streak-like lesions occurred along the direction of the vessels. Treatments such as raising the wounded limb, immobilization, local spray liquid dressing, and wet compression with magnesium sulfate were given. After 3 or 4 days, redness, swelling, pain, and streak-like lesions basically disappeared.
  • Zhang Yan, Zhou Zhigang
    Adverse Drug Reactions Journal. 2024, 26(7): 431-436. https://doi.org/10.3760/cma.j.cn114015‑20240220‑00100
    Kratom is a new psychoactive substance originating from Southeast Asia, and its spe‑cial medicinal value in Southeast Asia and the harm of abuse in Europe and America have always been aconcern. In recent years, the abuse of kratom has occurred in China. It is urgent to improve the understand‑ing of Kratom and strengthen the supervision of its use. This paper summarizes the current situation ofKratom application at home and abroad, reviews the research progress of its active ingredients, pharmacologicaleffects, adverse reactions and addiction, analyzes the regulatory situation of Kratom, and puts forward sugges‑tions on how to strengthen the regulation in China.
  • Li Yun, Li Qing, Jin Yueping, Cai Yuewei
    Adverse Drug Reactions Journal. 2020, 22(8): 479-481. https://doi.org/10.3760/cma.j.cn114015-20200714-00773
    A 34-year-old female patient with Helicobacter pylori (Hp) infection received quadruple therapy for eradication of Hp infection, which contained esomeprazole, colloidal bismuth pectin, amoxicillin, and furazolidone. Before the treatment, the patient′s physical examination results were normal except the positive 14C urea breath test. On day 6 of medication, the patient developed fever, nausea, vomiting, and diarrhea, which returned to normal after drug withdrawal. About 20-minutes after taking furazolidone again 3 days later, the patient developed dizziness, amaurosis, vomiting, hand and foot convulsions with chills, unconsciousness, high fever, muscle soreness, fatigue, and generalized skin congestion with rash. Meanwhile her blood pressure was 76/34-mmHg. Laboratory tests showed alanine aminotransferase (ALT) 365-U/L and aspartate aminotransferase (AST) 596-U/L. Anaphylactic shock, and drug-induced liver injury were consi- dered. It was considered that the anaphylactic shock might be related to furazolidone, and liver injury might be related to esomeprazole, amoxicillin, and furazolidone. Symptomatic treatments such as blood pressure-raising, cooling, anti-allergy, and liver-protective drugs were given immediately. Ten days later, the above-mentioned symptoms disappeared completely, her body temperature was 36.3-℃, blood pressure was 126/75-mmHg, ALT was 59-U/L, and AST was 38-U/L.
  • 论著
    ZHANG Xiao-ran;QIU Ze-wu;CUI Wen-hua;PENG Xiao-bo
    . 2013, 15(2): 83-4.
    ObjectiveTo analyze and summarize the clinical manifestations and treatments of acute thallium poisoning.MethodsThe clinical data of patients with acute thallium poisoning, who were hospitalized in Affiliated Hospital of Academy of Military Medical Science from 2009 to 2011 were collected and analyzed retrospectively.ResultsFourteen patients with acute thallium poisoning comprised 8 males and 6 females with an average age of 42 years (rang 9 to 68) were hospitalized from 2009 to 2011. Of them, 1 case complained poisoning by others; 1 case suspected poisoning by accidental mistake; 2 cases lived together with thallium poisoned patients; the other 10 poisoned cases were of unknown aetiology. The early clinical manifestations of thallium poisoning were gastrointestinal symptoms including nausea, vomiting, and abdominal pain (5 cases), and neurological symptoms including acroanesthesia, pain, and memory loss (13 cases). Ten patients developed abnormal hepatic function, 8 patients developed hair loss, and in one patient Mees line appeared. Before treatment, the patients′ serum and urine thallium levels were 3764.0 to 197 μg/L and 29 100.0 to 0.2 μg/L, respectively. After the supportive therapy (1 case), prussian blue therapy (4 cases) and prussian blue combined with hemoperfusion therapy (9 cases), the patients′ serum and urine thallium levels decreased to 68.0 to 2.4 μg/L and 542.0 to 11.3 μg/L, respectively. Thirteen patients with neurological symptoms were markedly improved during the hospitalization period, but the mild acroanesthesia and pain in limbs were still existed after discharge. The gastrointestinal symptoms in five patients were alleviated or disappeared within a week. The liver enzyme levels in ten patients with abnormal hepatic function returned to the normal levels within 2 to 4 weeks. Of the 8 patients with hair loss, 5 were improved during the hospitalization period, the other 3 had no obvious changes. No significant change of sign appeared in the patient with Mees line.ConclusionsIf a patient has gastroenteric symptoms of unknown causes together with neurological symptoms, it should be considered as heavy metal poisoning. Prussian blue combined with hemoperfusion has good efficacy and safety in treatment of thallium poisoning.
  • Zhang Jianxin, Zhu Fengyan, Song Yanying
    Adverse Drug Reactions Journal. 2007, 9(5): 324-328.
    Objective:To observe the effects of risperidone on blood glucose and lipid in first-episode,drug-na?ve patients with schizophrenia.Methods:Sixty-two first-episode,drug-na?ve patients with schizophrenia were given risperidone 2~6 mg once daily for 12 weeks.The mental symptoms were assessed with PANSS,adverse reactions were assessed with TESS,and blood glucose,total cholesterol(TC),triglycerides(TG),high-density lipoproteins(HDL),and low-density lipoproteins(LDL)were measured with glucose oxidase methods before administration and in the end of the fourth,eighth,and twelfth week after administration.Results:Of the sixty-two patients,22(35.48%)were cured,38(61.29%)marked improved,and 2(3.23%)responded after 12 weeks of treatment.Twenty-two patients developed adverse reactions including insomnia,dry mouth,constipation,tremor,and akathisia.The differences were statistically significant as compared TC and TG concentration in the end of the fourth,eighth,and twelfth week during treatment,HDL concentration in the end of eighth week during treatment,and LDL concentration in the end of the twelfth week during treatment with those before treatment(P<0.01,P<0.05,P<0.05).The difference as in blood glucose concentration were no statistically significant as compared before medication with after medication(P>0.05).Conclusion:Risperidone may effective relieve the symptoms of first-episode patients with schizophrenia and its adverse reactions are relatively mild.Risperidone has no effects on blood glucose,but it may obviously elevate the levels of TC and TG.
  • 病例报告
    . 2001, 3(2): 114-115.
  • 专题讲座
    . 2005, 7(2): 125-127.
  • 国外文献题录
    . 2001, 3(1): 58-59.
  • 中毒救治
    He Chengjian;Deng Lipu;Liao Guqing;Xie Rongjun;Liu Wei
    . 2009, 11(2): 114-3.

    Objective:To investigate the clinical features of raw fish gallbladder poisoning. Methods: Between May 2004 and October 2008, clinical data of inpatients with raw fish gallbladder poisoning were collected. The patients’ sex and age, number of raw fish gallbladder ingestion, onset time and symptoms of intoxication, liver and renal function, myocardial enzyme levels, management, and outcome were analysed. Results: A total of 24 cases of raw fish gallbladder poisoning comprised 9 men and 15 women aged 8-65 years [average age (26.9±3.4) years]. Every patient took 1-2 raw fish gallbladder. Acute gastrointestinal disorders occurred 2-72 hours after taking raw fish gallbladder. Of them, 15 patients were accompanied with renal failure [BUN (34.5±13.7) mmol/L, SCr (825±172) μmol/L], 12 were accompanied with liver function insufficiency [ALT (958±523.5) U/L, AST (562.5±256.8) U/L], and 12 were accompanied with heart damage [LDH (3 423.4±101.5) U/L]. After blood perfusion and hemodialysis, the patients recovered. Conclusion: Raw fish gallbladder may cause multiorgan failure. Blood perfusion combined with hemodialysis is an effective measure for management of raw fish gallbladder poisoning.

  • Jia Qinhui;Ning Hongxia;Li Fang
    Adverse Drug Reactions Journal. 2009, 11(6): 427-1.
    A 86yearold man with aplastic anemia received omeprazole 80 mg/d via an IV pump for control of upper gastrointestinal hemorrhage. On day 8 of therapy, the patient developed agitation, hyperphasia, irritability, loss of selfcontrol, refusal to eat, pulling out a stomach tube on his own, hallucination and illusion, and refusal of all therapy. On day 10 of therapy, omeprazole was stopped. Three days later, his mental symptoms relieved gradually. The abovementioned symptoms recurred after readministration of omeprazole via an IV pump and subsided after the drug discontinuation.
  • 中药不良反应
    Ma Hairong①;Tian Di②
    . 2007, 9(6): 444-445.
    A 43-year-old man with hypertension,cerebral infarction,and pharyngitis was treated with 40 ml of Qingkailing injection mixed with 250 ml of glucose injection 10% by intravenous infusion at a rate of 45 drops/min.After 30 minutes of infusion,he developed nausea,vomiting,a high fever(T 40 ℃),palpitation,chest distress,short breath,dyspnoea,cyanosis of lips,and profuse sweating.His BP declined from 170/140 mmHg to 85/40 mmHg,and he had a respiratory rate of 32 breaths/min and a pulse rate of 110 beats/min.An ECG revealed myocardial ischemia.Qingkailing injection was stopped immediately.The patient was given treatment with anti-anaphylaxis,blood volume expansion,elevation of blood pressure,and cardiopulmonary resuscitation.Thirty-eight minutes later,the man died.
  • 论著
    Xu Jingfeng;Liu Jie;Xu Lin;Fan Weihong
    . 2007, 9(6): 388-392.
    Objective:To investigate the drug resistance of pathogenic microorganisms from the in-patients in our hospital.Methods:The pathogenic microorganisms were isolated from in-patients' samples of blood,urine,sputum,genital tract secretion,feces,and wound secretion between January 2005 and December 2006.The antibacterial sensitivity testing of isolated bacterial strains was performed and their resistance rate was analyzed.Results:The predominant isolates were Escherichia coli(17.6%),Klebsiella pneumonia(16.1%),Pseudomonas aeruginos(23.5%),Acinetobacter baumannii(12.8%),Enterobacter cloacae(19.8%),and Staphylococcus aureus(10.2%).The detect rate of ESBL-producing isolates,from Klebsiella pneumonia and Escherichia coli was 41.3%.Gram-negative bacteria were susceptible to piperacillin sodium/tazobactam sodium,imipenem,and meropenem.The resistance rate of Staphylococcus aureus to cephalosporins was >70%.The average resistance rate of ESBL-producing organisms to 21 commonly used antibacterial agents was 74.1%.The detection rates of pathogenic microorganisms was as follows:ESBL-producing organisms 41.3%,Staphylococcus aureus 10.2%,oxacillin-resistant Staphylococcus aureus 49.0%.Vancomycin-resistant Staphylococcus was undetected.Conclusion:ESBL-producing organisms and oxacillin-resistant Staphylococcus aureus have multi-resistance.And antibacterial sensitivity testing of isolated bacterial strains is important in the selection of effective antibacterial agents and their rational use for clinical therapy
  • 相互作用
    . 2007, 9(1): 36-38.
    小剂量(75~150mg)阿司匹林(ASA)是防治心脑血管疾病(心肌梗死、脑梗死等)的基本药物之一。布洛芬是非甾体类抗炎药(NSAIDs),广泛应用于儿童和成年人。但长期服用小剂量阿司匹林预防心血管疾病,能否同时服用布洛芬治疗慢性疼痛,是人们普通关注的问题。本文对阿司匹林与布洛芬相互作用的有关文献进行综述,供临床安全用药参考。
  • . 2015, 17(6): 475-475.
  • Zhao Jing, Zhang Zhong
    . 2016, 18(2): 150.
    A 73-year-old male with unilateral skull skin herpes simplex virus infection received an IV infusion of acyclovir 500 mg. One and half hours later he received intramuscular injection of mecobalamin injection 0.5 mg. About 15 minutes after intramuscular injection of mecobalamin, the patient suddenly developed dizziness, sweat, paleness, obnubilation, no response to voice stimuli, and blood pressure was undetectable. He received the treatments with oxygen inhalation, sufficient fluid resuscitation, and regimens to raise blood pressure. The patient became conscious gradually, pulse rate was 63 beats/min, blood pressure was 140/73mmHg(1 mmHg=0.133 kPa), respiratory rate was 20 times/min. After replacing mecobalamin with muscular amino acids, peptides and nucleotide, the similar adverse reactions did not recur.
  • Jin Xueqin, Ru Jinli, Xie Xiaoxiang, Sun Huiping, Che Guozhu
    . 2015, 17(3): 223.
    A 30-year-old male was diagnosed as tenosynovitis for complains of pain and swelling in the right metacarpophalangeal joint of thumb. He received a local blockade injection with 1 ml of compound  betamethasone. He felt immediate relief of the pain and swelling. After 24 hours, he started a persistent hiccups which exerted marked influcence on his sleep and apptite. He tried to treat with omeprazole and metoclopramide, domperidone, but they had no obvious effect. So the patient took herbal medicine by himself. The hicuups continued for about 2 days and gradually disappeared.
  • Huang Hongping, Chen Qingxin, Yu Tian, Chen Huaman
    Adverse Drug Reactions Journal. 2023, 25(1): 17-20. https://doi.org/10.3760/cma.j.cn114015-20220928-00881
    Objective To explore the safety of azivudine tablets in the treatment of moderate coronavirus disease 2019 (COVID-19). Methods Clinical data of adult COVID-19 patients who were hospitalized and treated with azivudine tablets at Xinglin Branch, the First Affiliated Hospital of Xiamen University from August 18 to September 18, 2022 were collected. The incidence, clinical manifestations, severity, and outcome of adverse reactions during treatment were analyzed descriptively and statistically. Results A total of 117 patients were entered in the analysis, including 68 males (58.1%) and 49 females (41.9%); the age ranged from 18 to 76 years, with a median age of 44 years. The course of COVID-19 before taking azivudine tablets ranged from 2 to 25 days, with an average time of 13 days. Azivudine tablets were applicated for 2-14 days with an average time of 8 days. Among 117 patients, 10 patients (8.5%) had adverse reactions during taking azivudine tablets, including 5 patients with gastrointestinal reactions (2 had nausea, 2 had diarrhea, and 1 had abdominal distension), 2 patients with liver dysfunction and 2 patients with dizziness, 1 patient with elevated serum triglyceride level, and 1 with fatigue. Of them, one patient had 2 times of adverse reactions, which manifested as dizziness and abdominal distension. All patients recovered after discontinuation of azivudine tablets and/or symptomatic treatments. The severity of adverse reactions was grade 1 in 7 patients and grade 2 in 3 patients, and no grade 3 and above serious adverse reactions occurred. All adverse reactions observed in the study had been recorded in the drug label, and no new adverse reactions were found. Conclusions Azivudine tablets is safe and well tolerated in the treatment of moderate COVID-19. The common adverse reactions were gastrointestinal reactions, abnormal liver function, and dizziness.
  • Lin Xiaofeng, Wang Fangfang, Fei Yan
    Adverse Drug Reactions Journal. 2017, 19(6): 438.
    Medication treatment during pregnancy has both pros and cons on the fetus. The drugs commonly used in pregnancy include: (1) Blood and hematopoietic system drugs, which are folic acid and iron-containing drugs mainly. Folic acid can reduce fetal neural tube deformity and multiple risks in early pregnancy, but it may also affect fetal bone formation. Iron supplement can effectively reduce the risk of maternal anemia, low birth weight and premature birth. (2) Digestive and metabolic system agents, which include antemetic, antacids, magnesium, calcium and other minerals, insulin and antidiabetic drugs. Vitamin B6, H1-receptor antagonists, trimethobenzamide and metoclopramide are safe and effective on morning sickness, but phenothiazine has the risk of teratogenic effects on fetus. (3) Systemic anti-infection agents, which include penicillin G, ampicillin, piperacillin, mezlocillin etc. Roxithromycin, erythromycin and azithromycin are commonly used because the macrolides are difficult to cross the placental barrier. Clarithromycin and spiramycin should be used with caution because of the toxicity to the fetus. (4) Skin disease agents are mainly for local application, including calamine lotion, antifungal agents, antibiotic ointment and corticosteroid ointment, which have less effect on the fetus. The measures for risk prevention in pregnancy drugs use include improving education on safe medication during pregnancy, strengthening the communication between the pregnant women and the medical staff, providing the counseling of safe medication and the individual administration.
  • 病例报告
    Wu Chunying;Qian Yanbin
    . 2007, 9(6): 435-435.
    A 76-year-old woman with chronic renal insufficiency was admitted with cerebral infarction and hypertension.During hospitalization,she received IV nitroglycerin 5 mg diluted in 100 ml of sodium chloride injection 0.9% for treating chest pain and chest distress.After infusion,the patient developed left eye pain,blurred vision,and headache.After administration of nitroglycerin on day 2,her left eye pain was aggravated and visual acuity was found that only light perception remained.An ophthalmic examination of her left eye showed a vertical oval-shaped pupil(4 to 5 mm in diameter) with no light reflex,bulbar conjunctival congestion and edema,corneal edema,lens opacity,shallow anterior chamber(<1/3 CT),and an intraocular pressure of 54 mmHg.An acute attack of angle-closure glaucoma was diagnosed.Nitroglycerin was stopped immediately.He was administered with IV mannitol,oral acetazolamide and sodium bicarbonate,carteolol eye drops,and pilocarpine eye drops.After 8 hours of administration…更多,symptom of her the left eye gradually improved,and her intraocular pressure was within normal limits.
  • 中毒救治
    Wu Liyonga;Che Linhaia;Liu Fangyanb;Li Yalinb;Tang Huib;Xing Xiurongb;Sun Changyib;Qin Jianb;Jia Jianpinga
    . 2010, 12(2): 117-3.
    Methamphetamine, commonly called as ice (MA), is illegal drugs. MA abuse could cause severe psychiatric and physical disorders even lifethreatening reactions. A 28-year-old man had a history of MA abuse for one year and more and he took MA four to five times every month on average. The patient experienced 5~6 episodes of agitation, confusion, convulsion of extremities, and trismus within 4 hours, and each episode lasted for 3~5 minutes. He subsequently was admitted to hospital. Physical examination showed temperature of 38.5℃, a BP of 140/90 mm Hg, a respiratory rate of 30 breaths/min, and a heart rate of 120 beats/min, delirium, confusion, sluggish light reflex, agitation, and generalized polyhydrosis. Toxicological analysis revealed the following results: serum MA 0.2 μg/ml, serum amphetamine 0.1 μg/ml, urine MA 12.3 μg/ml, urine amphetamine 1.3 μg/ml. MA serum concentration reached a fatal dose of the drug. He underwent endotracheal intubation and ventilator support. Meanwhile he was given symptomatic and supportive treatments. Two days later, he returned to consciousness and spontaneous respiration. The patient was discharged after six days of hospitalization in the intensive care unit.
  • 滥用误用
    Li Qinghong;Zhao Xiaohong;Qiao Shi;Li Fei
    . 2007, 9(4): 262-264.
    Objective:To study on the occurance of acute gastritis during detoxication of heroin-dependent patients.Methods:In retrospective study,the clinical data of 2 084 heroin-dependent patients with acute gastritis diagnosed by gastroscopy were collected,the relationship among gastritis and the administration,dosage,duration,and abstinence time of heroin abuse were analysed.Results:Of 2 084 patients,442 cases(21.21%)occurred acute gastritis.The incidence of acute gastritis was higher in patients using the higher doses,longer duration of medication,longer abstinence time,and intravenous injection(P<0.01).Conclusion:Heroin-dependent patients may occur acute gastritis during detoxication and care should be given to it.
  • LIU Pei;REN Ke-yu;WANG Yan-ting;ZHANG Wei;CAO Bin;WEI Liang-zhou
    . 2013, 15(5): 288-1.
    A 45-year-old man received rabeprazole sodium enteric-coated tablets 10 mg once daily for acid regurgitation. Three week later, the symptom worsened, so he self-medicated double dosage. He developed generalized weakness, inappetence, dark yellow urine after 3 days. Rabeprazole sodium enteric-coated tablets was stopped. Laboratory tests showed the following values: alanine aminotransferase 401 U/mL, aspartate aminotransferase 314 U/mL, alkaline phosphatase 143 U/mL, γ-glutamyl transferase 359 U/mL, total bilirubin 22.7 μmol/L. He was given liver protective drugs. One week later, the levels of alanine aminotransferase and aspartate aminotransferase were 40 U/L and 15 U/L, respectively.
  • 安全用药
    Li Xiaoling;Wang Yuqin
    . 2009, 11(4): 257-3.
    Trastuzumab is a humanised monoclonal antibody used for treatment of metastatic breast carcinoma in patients whose tumors overexpress the human epidermal growth factor receptor-2 (HER-2) protein. Recently, trastuzumabinduced cardiotoxicity has caused widespread concern. Manifestations of trastuzumabinduced cardiotoxicity include asymptomatic decreases in left ventricular ejection fraction, tachycardia, palpitation, dyspnea, chest pain, which may progress to congestive heart failure. The risk factors for trastuzumabinduced cardiotoxicity are advanced age, a previous history of heart disease, and trastuzumab combined with anthracyclines. The mechanism of cardiotoxicity induced by trastuzumab is unclear, it may be associated with inhibition of HER2 signalling pathway. Prevention and treatment include monitoring left ventricular ejection fraction regularly and use of angiotensinconverting enzyme inhibitors.
  • 药物滥用
    Zhang Kaigao
    . 2009, 11(3): 198-3.
    The term of chronic non-cancer pain refers to a painful condition which is caused by various kinds of diseases and not associated with cancer lasting more than six months.Recently, prescription opioid use for treatment of chronic noncancer pain is increasing. Prescription opioid abuse has been a health problem and caused widespread concern. Risk factors for prescription opioid abuse are mainly non-opioid substance abuse and mental disorders. The patient with non-cancer pain and behaviors of non-opioid substance abuse or mental disorders is prone to develop prescription opioid abuse.
    KEY WORDS
  • 病例报告
    Xie Zhijina;Wang Yanchuana;Wang Taob;Sun Weia;He Yangjuna
    . 2009, 11(5): 361-1.
    A 79-year-old man with tinea cruris received an IV infusion of fulconazole 200 mg/d for prevention of fungal infection after undergoing an femoral head prosthetic replacement. Three hours after infusion completion, the patient developed facial flushing, hyperphasia, insomnia, and mild excited state. The next day, his symptoms improved. The above-mentioned symptoms recurred after readministration of fluconazole injection, and then he presented with disorientation, hyperemotion, flight of ideas, visual hallucination, and delusion of persecution. Fluconazole was stopped and switched to itraconazole 0.2 g once daily. Two days later, his symptoms disappeared.
  • 实验论著
    Liu Renhui;Wang Pei;Jin Xihong;Wang Yali;Kang Xue;Wang Xiujuan
    . 2010, 12(1): 5-5.
    Objective: To observe the effects of dexamethasone on hypothalamicpituitaryadrenocortical (HPA) axis and bone metabolism in rats with ovalbumininduced asthma at different stages of intervention (before withdrawal, during withdrawal, after withdrawal). Methods:Ninety rats were randomly divided into three groups (30 rats in each group): the normal control group, the asthmatic model group, the dexamethasone intervention group. The rats in each group were redivided respectively into 3 subgroups (10 rats in each subproup) according to the time to be sacrificed (on days 49, 77, and 91). The rat model of asthma was established by ovalbumin (OVA) injection sensitization followed by challenge with gaseous ovalbumin. Dexamethasone intervention group received intraabdominal injection of dexamethasone 0.5 mg/kg from day 35 to day 48 (at the stage before withdrawal). The dose of dexamethasone was decreased by 0.1mg/kg every week from day 49 to day 76 (at the stage during withdrawal). Dexamethasone was stopped on day 77 and observations were carried on until day 90 (at the stage after withdrawal). Gaseous normal saline solution containing 0.1%OVA was inhaled twice a week in the asthmatic model and dexamethasone intervention groups. At all stages of the experiment, the indexes of spleen and adrenal, levels of serum CORT, plasma ACTH, hypothalamic CRH, and plasma BGP were measured. Results:(1) On day 49, in the normal control, asthmatic model, and dexamethasone intervention groups, the spleen indexes were 1.504±0.213, 1.548±0.208, and 1.254±0.239, respectively; the adrenal indexes were 0.132±0.039, 0.108±0.027, and 0.065±0.017, respectively; the levels of CORT were (2 301±628)ng/L, (1 658±486)ng/L, and (235±160)ng/L, respectively; the levels of ACTH were (62.7±17.4)ng/L, (32.7±17.2)ng/L, and (19.7±8.8)ng/L, respectively; the levels of CRH were (5.77±2.01)ng/mg·prot, (4.20±1.87)ng/mg·prot, and (3.40±1.28)ng/mg·prot, respectively; the levels of BGP were (5.22±2.14)μg/L, (3.64±1.40)μg/L, and (0.65±0.62)μg/L, respectively. The levels of ACTH and CRH in asthmatic model group were significantly lower than those in the normal control group (P<0.01 and P<0.05, respectively). The level of CRH in dexamethasone intervention group was significantly lower than that in the normal control group. Other laboratory values in dexamethasone intervention group were significantly lower than those in the normal control and asthmatic model groups. (2) On day 77, in the normal control, asthmatic model, and dexamethasone intervention groups, the spleen indexes were 1.515±0.169, 1.567±0.180, and 1.287±0.380, respectively; the adrenal indexes were 0.112±0.058, 0.100±0.027, and 0.069±0.022, respectively; the levels of CORT were (2 433±379)ng/L, (1 905±410)ng/L, and (355±239)ng/L, respectively; the levels of ACTH were (65.3±31.0)ng/L, (38.4±11.7)ng/L, and (39.6±14.9)ng/L, respectively; the levels of CRH were (5.05±1.62)ng/mg·prot, (4.15±1.39)ng/mg·prot, and (3.04±1.37)ng/mg·prot, respectively; the levels of BGP were (2.63±0.96)μg/L, (2.50±1.20)μg/L, and (0.79±0.53)μg/L, respectively. The level of CORT in the asthmatic model group was significantly lower than that in the normal control group (P<0.01). The indexes of spleen and the adrenal, the levels of CORT, CRH, and BGP in the dexamethasone intervention group were significantly lower than those in the normal control and asthmatic model groups (P<0.05 or P<0.01), except the level of ACTH. (3) On day 91, in the normal control, asthmatic model, and dexamethasone intervention groups, the spleen indexes were 1.463±0.190, 1.786±0.316, and 2.278±0.412, respectively; the adrenal indexes were 0.112±0.021, 0.110±0.020, and 0.093±0.017, respectively; the levels of CORT were (2 627±509)ng/L, (2 318±364)ng/L, and (2 212±400)ng/L, respectively; the levels of ACTH were (63.0±33.5)ng/L, (48.8±19.9)ng/L, and (30.7±19.1)ng/L, respectively; the levels of CRH were (5.39±1.40)ng/mg·prot, (3.80±0.94)ng/mg·prot, and (3.67±1.09)ng/mg·prot, respectively; the levels of BGP were (4.58±2.19)μg/L, (3.21±1.34)μg/L, and (1.93±0.91)μg/L, respectively. The spleen index in the asthmatic model group was significantly higher than that in the normal control group (P<0.01). The CRH level in the asthmatic model group was significantly lower than that in the normal control group (P<0.01). The spleen index in dexamethasone intervention group was significantly higher than that in the normal control and asthmatic model groups. The adrenal index, the levels of ACTH and BGP in dexamethasone intervention group were significantly lower than those in the normal control and asthmatic model groups (P<0.05, P< 0.01). The levels of CORT and CRH in dexamethasone intervention group were significantly lower than those in the normal control group(P<0.05, P<0.01). Conclusion:Dexamethasone has different inhibitory effect on HPA axisrelated indexes at different stages in rats of asthmatic model. It also inhibit the bone metabolism at all stages.
  • 调查研究
    Li Yalin;Zhao Yan;Tang Hui;Li Xiaoyu;Sun Changyi;Qin Jian
    . 2006, 8(6): 428-430.
    Objective:To investigate the effects of etimicin plus other antibacterials on renal function in elderly patients with severe pneumonia. Methods:Forty-seven elderly patients with severe pneumonia who were receiving etimicin plus other antibacterials were analysed retrospectively. Of the 47 elderly patients,32 were 60~79 years old,15 were old than 80 years. The changes in serum creatinine (Scr),blood urea nitrogen (BUN),and urine protein were observed before and after treatment,and creatinime clearance rate (Ccr) were calculated. Results:Before etimicin treatment,the mean value of Scr,BUN and Ccr in the 42 patients were 106±26.5 μmol/L,6.3±2.9 mmol/L,and 44±14 ml/min respectively. After etimicin treatment,the mean value of Scr and BUN were reduced to 97±17.7 μmol/L and 5.4±2.6 mmol/L,respectively,and Ccr was elevated to 46±13 ml/min. But there were no statistical differences between before treatment and after treatment in their data (P>0.05). Urine protein was decreased obviously after treatment (P<0.01). Conclusion:There is no marked renal toxicity of etimicin plus other antibacterials in the treatment of the elderly patients with severe pneumonia,so it might be a safer therapy for thepatients.
  • 调查研究
    Jiang Yuyong
    . 2003, 5(1): 11-13.
    Objective: To analyze the causes of drug rash misdiagnosed as eruptive contagious diseases. Method; 18 inpa-tients misdiagnosed as eruptive contagious diseases were reviewed in our hospital in last eight years. Results; 1.Drug rash was supposed to be measles by mistake in the first place. 2.Antibacterials and nonsteroidal anti-inflammatory drugs were the most common causes of drug rash. 3.Doctors might be careless in consultation and examination although the diseases shared some presentations in clinic. Conclusion; Diagnosis of drug rash should be improved so as to reduce the misdiagnosis that would have been avoided.
  • 药物滥用
    . 2005, 7(3): 192-195.
    滥用MDMA(迷魂药)的年青人不断增加。他们错误地认为使用MDMA不引起伤害。大多数医药卫生人员也不甚了解使用MDMA的不良反应和并发症。因此,有必要强化卫生部门及其工作者掌握MDMA药理学和神经毒性知识,对中毒者起动早期治疗,降低危害。
  • 病例报告
    . 2005, 7(2): 133-133.
  • 调查研究
    He Suiping;Li Jianwei;Quan Yanli;Huan Yanru
    . 2000, 2(4): 232-235.
    Objective: To understand the condition of the antibacterial drug utilization and the effects of these drugs on the nosocomial infections. Methods: The data of 44 patients of the nosocomial infections were in entry and statistical analysis with a software of pharmacoepidemiology. Results: In 44 cases, the frequency of antibacterial administration was 88.64% before nosocomial infections, 31.86% for preventive purposes and 33.63% for unreasonable application. Moreover, the microbiological assay and drug sensitive test were not done in 95.5 % of the cases before antibacterials taken. The nosocomial infections mostly occured in the patients who took the drugs for a long time, the gastrointestinal infections standing first on the list. In 8 risk factors of the nosocomial infections, the constitutive ratio and afterwards infection rate of the broadspectrum antibacterial utilization were 29.06 % and 3.93 % , ranking the first and the seventh, respectively. Conclution: Antibacterials are empirically used in clinic for both prevention and treatment with less attention to the microbiological assay and the drug sensitive test. The administration of an-tibacterials is a protective factor, and one of the risk factors for the nosocomial infections, too.
  • 综述
    . 2001, 3(4): 215-221.
    他汀类药物通过其有效地降低总胆固醇和LDL胆固醇及药物对动脉粥样硬化的直接作用,在正常和高血脂个体的一、二级预防中,显著降低冠脉突发事件和冠脉性死亡,降低总死亡率。随着这类药物的广泛应用,其安全性越来越受到人们的重视。他汀类药物的毒副作用可能对机体的肝脏功能及骨骼肌、视觉系统、中枢神经系统造成损伤,但通常状态下,这些毒副作用的发生率较低,多为可逆性损害,不会对机体造成很大的损伤,药物的临床效益远远大于其毒副作用的风险。不同类型他汀类药物的毒副作用也不相同。近来,他汀类药物的肌肉毒性及由此引起的肾功能衰竭已经受到人们的重视,有关机制有待于进一步研究。临床上合理、准确地选择药物,严格控制药物剂量、避免药物间相互作用,将有利于控制或减少药物毒副作用的发生。
  • 调查研究
    Bai Yuguoa;Zhang Aiqina;Li Jingmingb;Li Xiamingc;Zhang Moa;Jiao Pinga
    . 2009, 11(5): 330-5.
    Objective: To investigate the current situation of antibacterial use in inpatients for reference to rational drug use in clinical practice. Methods:In a retrospective study, five hundred case records of patients receiving antibacterials each year were randomly selected in Beijing Anzhen hospital in 2006 and 2007. The situation of prophylactic and therapeutic uses of antibacterials were investigated, and the irrational phenomenon of antibacterial use was analyzed according to Beijing Medical Institutions Antibiotic Clinical Practice Guidelines. Results: In 2006, the 500 patients comprised 317 males and 183 females aged 5 months~89 years, average age was (55.6±15.6) years; of them, surgical patients was 194 and nonsurgical patients was 306. In 2007, the 500 patients comprised 236 males and 264 females aged one month to 90 years, average age was (52.7±24.6) years; of them, surgical patients were 209 and nonsurgical patients were 291. In 2006 and 2007, the patients receiving prophylactic use of antibacterials for grade I surgery were 162 cases (87.1%) and 122 cases (93.1%), respectively; before surgery, the patients who took more than 48 hours of treatment were 154 cases (95.1%) and 118 cases (96.7%), respectively; before grade I, II, and III surgery, the patients took more than 24 hours of treatment were 49 cases (28.8%) and 77 cases (38.5%), respectively. In 2006 and 2007, the patient with no indication receiving therapeutic antibacterial use were 152 cases (30.4%) and 97 cases (19.4%), respectively; the patients receiving inappropriate treatment course were 153 cases (30.6%) and 115 cases (23.0%), respectively; the patients receiving inappropriate combination therapy were 62 cases (74.7%) and 198 cases (65.8%), respectively; the patients receiving antibacterial sensitivity tests were 35 cases (7%) and 500 cases (100%), respectively; the patients whose drug therapy regimen were not adjusted according to the antibacterial sensitivity tests were 17 cases (48.8%) and 172 cases (34.4%), respectively. In addition, 4 patients aged <18 years in 2006 received fluoroquinolones inappropriately; 3 patients aged > 60 years in 2006 as well as 9 patients aged >60 years and 2 young children in 2007 treated with vancomycin without monitoring of renal function and dosage individualization. Conclusion: The situation of rational antibacterial use in inpatients significantly improved in 2007 compared with in 2006, but the level of rational drug use should be further raised in order to completely meet the demand of the “Guideline”.
  • 病例报告
    Han Haixiao;Li Junxiang;Jiang Yidun;He Lingyan
    . 2009, 11(1): 49-2.
    A 76yearold woman was administered with of oral levofloxacin 0.2 g twice daily for 5 days and levofloxacin eye drops for 1 week after undergoing cataract extraction. Two weeks later, the woman presented with asthenia, jaundiced skin and sclera, dark urine, abdominal distension, and anorexia. Laboratory investigations revealed the following levels: ALT 1 645 U/L,AST 885 U/L,γ-GT 198 U/L,ALP 155 U/L,TBil 68.9 μmol/L,DBil 42.8 μmol/L,IBil 26.1 μmol/L,ALB 33.9 g/L,APTT 41.8 s. She had no history of liver disease previously. Serological tests for hepatitis virus, cytomegalovirus, EB virus, rubella virus, and IgM of Coxsackie virus were negative; serological tests for antinuclear antibody and antimitochondrial antibody were negative. Other causes of liver damage were excluded. After 3 weeks of treatment with reduced glutathione, ursodesoxycholic acid, Yinzhihuang injection, and vitamin B complex, her jaundice markedly subsided and liver function tests showed the following: ALT 51 U/L,AST 33 U/L,γ-GT 79 U/L,ALP 102 U/L,TBil 19.2 μmol/L,DBil 5.8 μmol/L,IBil 13.2 μmol/L,ALB 42.1 g/L.
  • 病例报告
    Jia Ning;Zhao Pengtai;Zhong Chengfu;Liu Xiaozong;Liu Ying
    . 2009, 11(1): 22-2.
    An 82yearold man, who had a 15year history of type II diabetes, received a longterm treatment with 5 Xiaoke pills thrice daily. The medication was changed to diformin 0.25g twice daily three months ago. The man experienced fatigue in recent one week. Unconsciousness, spasm of extremities, convulsion, upward eye deviation, and trismus occurred abruptly five hours before admission. Physical examination showed light coma, hypermyotonia in his neck and extremities, bilateral positive Babinski sign. His blood glucose level was 1.70 mmol/L; his brain CT scan only revealed senile brain changes. Hypoglycemic coma was diagnosed. The patient was infused with 500ml of glucose injection 10% intravenously at once. Thirty minutes later, his convulsion ceased and his consciousness recovered gradually. Diformin was stopped and acarbose was given. His blood glucose level fluctuated between 5.6~10.8 mmol/L and his hypoglycemia did not reappear.
  • 病例报告
    Zhao Yue;Xie Ying;Hao Yongling
    . 2007, 9(3): 207-207.
    A 57-year-old woman with right thalamic hemorrhage was administered with baclofen 515mg thrice daily for treating his myospasm. Three months later, her regimen was changed to tizanidine hydrochloride 1mg thrice daily. On day 2 after administration of tizanidine, she developed excitement, euphoria, disturbance of thinking, and incoherence of speech. The values of laboratory tests revealed that the blood, stool, urine, electrolytes, liver and renal function were normal. A head CT scan showed no new focus was found. A medical and neurological examination revealed there was no new physical sign. After stopping use of tizanidine, the patient’s emotion was stabilized gradually and other similar psychiatric symptoms did not reappear.
  • 病例报告
    Wu Gangyong
    . 2007, 9(6): 434-434.
    A 62-year-old woman with acute left heart failure,lung infection,type 2 diabetes mellitus,and diabetic foot received furosemide,lanatoside C,and IV gatifloxacin 0.4 g injection once daily.Five days later,she developed bradycardia.An ECG revealed a sinus rhythm with a heart rate of 54 beats/min,a Q-T interval of 0.56 second,and ST-T wave changes.Gatifloxacin was discontinued immediately.She was given symptomatic treatment.Seven days later,the ECG showed her heart rate increased to 67 beats/min and her Q-T interval was 0.36 second.
  • Zhang Shuainan, Li Xuzhao, Wang Yu, Lu Fang, Liu Shumin
    . 2015, 17(6): 415-419.
    ObjectiveTo study the potential protective and toxic effects of Acanthopanax senticosus harms (AS) in rats.MethodsTwenty male SD rats were divided into the AS-treated and control groups by random number table method. Each group comprised 10 rats. The rats in the AS-treated group were gavage-fed with AS extracts 31.6 mg/kg (equivalent to crude drug 0.386 g/kg in human) once daily for 20 days and the volume of the drug was 10 ml/kg. The rats in the control group received an equal volume of saline once daily for 20 days. The urinary samples of 24 h from rats in the 2 groups which were gavage-fed for 1, 5, 10, 15, and 20 days were collected respectively. Ultra-performance liquid chromatography-quadrupole time-of-flight-mass spectrometry was used to detect the ion intensities of metabolites from urinary samples. The ion intensities of urinary metabolites at different time points in the 2 groups were compared. The ion intensity of each metabolite was normalized with respect to the total ion intensities to generate a data matrix. The data matrix at different time points were processed by partial least-squares-discrimination analysis (PLS-DA) of EZinfo software. Characteristic metabolites were screened according to the PLS-DA score plot. Two sets of data matrix with relatively large distance were further processed by orthogonal partial least-squares-discrimination analysis (OPLS-DA) and the variable importance of project (VIP) scores were calculated. Characteristic metabolites induced by AS intervention were screened from variables with VIP>1 and P<0.05 and their mass-charge ratios were detected and compared to the information in Human Metabolome Database (HMDB), and the corresponding metabolites were identified at last. The potential protective or toxic effects of AS in rats represented by these metabolites were analyzed through literature review.ResultsPLS-DA score plot showed that the urinary metabolic profiles at different time points in the 2 groups had good similarity within groups or time period and presented clustering phenomenon. The urinary metabolic profiles in rats in the 2 groups which were gavage-fed for 1, 5, 10, 15, and 20 days partly overlapped. The urinary metabolic profiles in rats in the AS-treated group with 20 days of AS treatment were far from those in the control group. Two sets of data matrix with relatively large displacement were further processed and 6 potential intervention targets of AS with VIP>1 and P<0.05 were screened and identified as 3-methylguanine, 3-methylglutarylcarnitine, 3-hydroxydodecanedioic acid, tiglylcarnitine, kynurenic acid, and 13-cis-retinoic acid by comparing with the information of HMDB. At the 20 d of AS-treated group, the expression of 3-methylguanine, kynurenic acid, and 3-hydroxydodecanedioic acid were up-regulated and the expression of tiglylcarnitine, 3-hydroxydodecanedioic acid, and 13-cis-retinoic acid were down regulated. By reviewing the related literature, kynurenic acid, 13-cis-retinoic acid, and 3-methylguanine may have potential protective effects in rats which were treated with AS and the other 3 metabolites may have potential toxicity.ConclusionThe potential intervention effects of AS in rats had two sides, which may have protective effects, and may also have toxic effects.
  • Xu Juntang
    Adverse Drug Reactions Journal. 2020, 22(8): 441-444. https://doi.org/10.3760/cma.j.cn114015-20200807-00850
    At present, there are two kinds of oral antithrombotic drugs commonly used, including antiplatelet agents and anticoagulants. Before initiation of antithrombotic drugs, the risk of bleeding should be routinely assessed and measures to prevent bleeding should be taken as soon as possible. Methods for improving the efficacy and safety of warfarin include close monitoring during use, anticoagulative management, physician training, and patient education. Novel oral anticoagulants are easy to use, take effect quickly, and their dosage need not be monitored and adjusted in routine clinical practice, but the liver and kidney function should be taken into consideration for dosing regimen. After acute coronary syndrome (ACS) and percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) was routinely given. The risk of bleeding and ischemia/thrombosis should be carefully evaluated and balanced before taking these medications, and the optimal drug combination and the duration of DAPT should be selected.
  • Yang Gangqi, Lu Wanting, Lu Yinying, Li Fei, Li Hongyan
    Adverse Drug Reactions Journal. 2022, 24(1): 30-34. https://doi.org/10.3760/cma.j.cn114015-20210223-00207
    Chemotherapy-induced neuropathic pain (CINP) is a common adverse reaction in cancer chemotherapy, which is dose-dependent. CINP initially presents as acute pain syndrome and can lead to chronic neuropathic pain if not cured or recurrent. The pathophysiological mechanisms of CINP include mitochondrial dysfunction, calcium dyshomeostasis, oxidative stress, activation of apoptotic pathways, loss of myelin and non-myelin fibers, activation of the immune system, and increased expression of ion channels, etc. The mechanism of neuropathic pain induced by different chemotherapeutic drugs is different. There is a lack of effective CINP control measures and the highly recognized therapeutic drug is serotonin and norepinephrine reuptake inhibitor duloxetine.
  • Shen Xiaoju, Zeng Jiawei, Wu Haiyan, Chen Jie, Chen Xiao
    ObjectiveTo understand the occurrence of vancomycin-associated acute kidney injury (AKI) in patients in the pediatric intensive care unit (PICU) and explore the risk factors.MethodsMedical records data of children in the PICU receiving vancomycin treatment, treatment course>48 h, and having vancomycin trough concentration monitoring data in the First Affiliated Hospital of Sun Yat-sen University from January 2013 to July 2017 were collected from the hospital information system and retrospectively analyzed. Occurrence of AKI was judged based on Pediatric-Modified RIFLE (pRIFLE) criteria. The children were divided into the AKI group and non-AKI group. The risk factors of vancomycin-associated AKI were analyzed using the multivariable logistic regression model.ResultsA total of 170 patients were entered in this study. Of them, 104 patients were male and 66 were female with ages from 5 days to 15.4 years and the median age was 1.3 years. Thirty-six patients (21.05%) developed AKI, including 31 patients (18.24%) with risk of kidney injury, 4 patients (2.35%) with kidney injury, and 1 patient (0.59%) with kidney failure, no patient with kidney loss and end-stage kidney disease. The results of multivariate logistic regression analysis showed that the elevated estimated creatinine clearance (OR=1.010, P<0.001), more than 5 kinds of concomitant nephrotoxic drugs (OR=2.808, P=0.019), average vancomycin trough level ≥17 mg/L (OR=10.426,P<0.001), combined with carbapenems antibacterial drugs (OR=4.263, P=0.013), and combined with voriconazole injection (OR=3.165, P=0.038) were all the independent risk factors of AKI occurrence.ConclusionsThe incidence of vancomycin-associated AKI was 21.18% in PICU patients in our hospital. Vancomycin trough level ≥17 mg/L and more than 5 kinds of concomitant nephrotoxic drugs would increase risk of AKI in PICU patients.
  • 病例报告
    Zhang Hanyu
    . 2014, 16(2): 123-2.

    A 37-year-old male received compound glycyrrhizin 25 mg three times daily for one month because of positive HBsAg, HBeAb, HBcAb and increased serum aminotransferase. He developed ache in both lower extremities and fatigue. Laboratory tests revealed the following results: serum potassium 1.8 mmol/L, creatine kinase 8378 U/L. The patient was considered to have compound glycyrrhizin-induced hypokalemia and rhabdomyolysis. Compound glycyrrhizin was stopped and the patient was treated with potassium supplement and fluid infusion for 10 days. His serum potassium increased to 5.1 mmol/L, creatine kinase decreased to 450 U/L. His ache in both lower extremities and fatigue symptoms disappeared.

  • 论坛
    . 2014, 16(2): 71-1.
  • Han Yi, Pei Fei
    . 2016, 18(5): 381.
    An 82-year-old man with dilated cardiomyopathy received Qili Qiangxin capsule 1.2 g thrice daily, Co-enzyme Q10 10 mg thrice daily and spironolactone 20 mg once daily. Digoxin 0.125 mg once daily was added to his regimen due to heart failure. Five days later, he was developed nausea, vomiting and sleepiness. His serum digoxin level was > 4 ng/ml. Digoxin was discontinued. He was treated with 10% potassium citrate solution 20 ml. On day 4 after drug withdrawal, the serum digoxin level was still>4 ng/ml.On day 5, the Qili Qiangxin capsule and spironolactone were stopped on the next day. On day 6, the nausea, vomiting and sleepiness were improved. One day 12, his serum digoxin level decreased to 2.3 ng/ml.
  • 病例报告
    Wang Laicheng;Lti Dongmei
    . 2007, 9(4): 285-286.
    A 33-year-old man and an 18-year-old man started receiving chemotherapy with VDCLP regimens(vincristine,daunomycin,cyclophosphamide,asparaginase,and dexamethasone)for acute lymphoblastic leukemia.On day 19 of chemotherapy,they continued receiving intravenously asparaginase 10 000 U and dexamethasone 10 mg once daily,and other drugs were discontinued.After 5 days of using the two drugs,they developed thirst,dry mouth,polydipsia,polyuria,and so on.Laboratory tests showed:fasting blood glucoses >30 mmol/L and urine glucose(++++).After withdrawal of the two drugs and insulin therapy,their fasting blood glucoses returned to normal.
  • 中药不良反应
    . 2007, 9(1): 60-60.
  • 论著
    Zhang Hui;Yan Shengli;Wang Yangang;Shi Shasha;Han Lihui
    . 2011, 13(4): 213-5.
    Objective: To study the relationship between the A/G polymorphism at position 49 in exon 1 of cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) gene and leukopenia caused by antithyroid drugs (ATD) in the Chinese Han patients with Graves’disease (GD) in the north China. Methods: The subjects in this study were patients with GD (the GD group) and the healthy people (the healthy control group) in the medical center for checking the body in the Affiliated Hospital of Qingdao University from September 2009 to June 2010. The GD group comprised 3 subgroups: the post-ATD therapy leucopenia group, the post-ATD therapy normal leucocytes group and the pre-ATD therapy leukopenia group. Clot of non-anticoagulative blood from a peripheral vein in each subject was collected, genomic DNA was extracted, and genotype at position 49 in exon 1 of CTLA-4 gene was detected using polymerase chain reaction-restriction fragment length polymorphism. A part of samples were selected randomly and sequenced. The genotype and allele frequencies were calculated. Results: Two hundred and eleven patients in the GD group (73 patients in the post-ATD therapy leukopenia group, 86 patients in the post-ATD therapy normal leucocytes group, and 52 patients in the pre-ATD therapy leukopenia group) and 85 healthy people in the healthy control group were enrolled in this study. In the GD group, the genotype frequencies of AA, AG and GG at position 49 in exon 1 of CTLA-4 gene were 2.4% (5 cases),38.8% (82 cases), and 58.8% (124 cases), respectively; the allele frequencies of A and G were 21.8% and 78.2%, respectively. In the healthy control group, the genotype frequencies of AA, AG and GG were 15.3% (13 cases), 32.9% (28 cases), and 51.8% (44 cases); the allele frequencies of A and G were 31.8% and 68.2%, respectively. The differences in the genotype and allele frequencies in the 2 groups were significant (χ2=17.74,P=0.000 1;χ2=6.48,P=0.01). There were no significant differences in the genotype and allele frequencies at position 49 in exon 1 of CTLA-4 gene between the post-ATD therapy leucopenia group, the post-ATD therapy normal leucocytes group, and the pre-ATD therapy leukopenia group (P>0.05). Conclusion: In Chinese Han patients in north China, the development of GD is related to polymorphism of CTLA-4 gene at position 49 in exon 1, and ATD therapy-induced leucopenia seems to be not related to the polymorphism.
  • 论著
    Zhang Yunjian;Liu Chunping;Zhang Weihua;Xia Guoguang
    . 2009, 11(1): 5-4.
    Objective: To analyse the clinical characteristics and management of syndrome of inappropriate secretion of antidiuretic hormone(SIADH) induced by pituitrin in order to benefit the safe use of pituitrin. Methods:Clinical data from patients with hemoptysis receiving pituitrin from 3 hospitals were collected between January 2000 and December 2007. The serum and urine sodium, plasma and urine osmolality, liver and renal functions, treatment, and outcome were analysed in patients who met the criteria for SIADH. Results: A total of 304 patients with hemoptysis received pituitrin therapy. Of them, 89 patients (53 men and 36 women) with age 21~82 years\[average age (57.6±21.3) years\] developed SIADH. The dosage and administration were as follows: an initial dose of pituitrin 6 U was given via a Murphy’s dropper, followed by 3~6 U/h via an infusion pump. After hemorrhage ceased, the dosage of pituitrin was decreased. The durations of treatment were 2~9 days. A cumulative dose was 76~800 U. Hyponatremia occurred in 36 days after starting pituitrin use. Thirty one patients (34.83%) were mild hyponatremia (serum sodium>120~130 mmol/L), 49 patients (55.06%) were moderate hyponatremia (serum sodium >110~120 mmol/L), and 9 patients (10.11%) were severe hyponatremia (serum sodium 104~110mmol/L). Sixtynine patients developed hyponatremiaassociated clinical symptoms including lassitude and asthenia in 55 cases (36.7% frequency), anorexia and nausea in 48 cases (32.0%), apathy, headache, and dizziness in 35 cases (23.3%), delirium, convnlsion, and coma in 12 cases (8.0%). After the dosage decrease or discontinuation of pituitrin, water restriction, and salt administration, 85 patients' serum sodium level return to within the normal limits, 2 patients with lung cancer died of uncontrolled pulmonary hemorrhage, and the other 2 patients developed central pontine myelinolysis (CPM) leading to upper and lower limb dyskinesia and dysphasia. Conclusion: Pituitrin might cause SIADH, and hyponatremia occurring is doserelated. Therefore, a suitable dosage of pituitrin should be the one which can just stop bleeding, and high dosage of pituitrin should be avoided if possible.
  • 病例报告
    Chen Minjianga;Ye Wenlingb;Li Xuemeib
    . 2008, 10(5): 0-0.

    A 29-year-old woman was hospitalized with chronic renal insufficiency and hyperthyroidism. She was given propranolol 10mg thrice daily for treating sinus tachycardia. Her blood potassium level was 4.64 mmol/L before propranolol therapy, and increased to 6.41mmol/L on day 9 of treatment,but his urinary volume did not decrease and no evidence showed that his renal function deteriorated. Her blood potassium level still remained elevated after treatment with low potassium diet, intravenous injection of hypertonic glucose, insulin,and furosemide. The blood potassium level returned to normal range after reducing dosage of propranolol, and elevated once more after increasing dosage again. Propranolol was discontinued and changed to metoprolol. His blood potassium level normalized.

  • 学术讨论
    . 2001, 3(3): 187-192.
    药物不良反应的资料主要来源于新药上市前的临床试验和上市后监测。与药物有效性资料不同,药物不良反应资料十分零散,以个案报告居多,加上受到各种内外因素的制约,各单独研究结果或报告之间存在较大的异质性,这在药物不良反应发生率的报道方面显得尤为突出,很难在药物治疗实践中作为可靠的科学依据。本文分析了药物不良反应资料汇总中存在的问题,揭示其原因或影响因素,有针对性地提出具体的解决办法。
  • 论著
    Fan wanhu;.Zhang shuIin
    . 2006, 8(6): 407-410.
    Objective:To study the safety of peginterferon α-2b plus ribavirin for treating chronic hepatitis C. Methods:Forty patients with chronic hepatitis C were divided randomizely into two groups:treatment group (26 cases) and control group (14 cases). The two groups were well-matched at entry,with no statistical differences in the patients' characteristics including average age,hight,weight,blood pressure,heart rate,temperature,and so on (P>0.05). The patients in the treatment group were administered with peginterferonα-2b 50 μg subcutaneously,once a week,plus ribavirin 800~1050 mg by mouth,once daily. The patients in the control group were administered with recombinant interferon α-2b 3 MIU subcutaneously,three times a week,plus ribavirin 800~1050 mg by mouth,once daily. The total therapy duration for the two groups was 48 weeks,and a 24-week observation was performed after treatments. Results:The manifestations of adverse reactions in the two groups were almost same,and the common signs and symptoms were fatigue,indisposition,fever,nausea,thrombocytopenia,hypothyroidism,and so on. There was no significant difference between the two groups in the incidence of adverse reactions.Conclusion:The safety of peginterferonα-2b plus ribavirin for treating chronic hepatitis C is comparable to that of recombinant interferonα-2b plus ribavirin.
  • 病例报告
    Liu Chunmei;Li Haihong;Wang Wei
    . 2008, 10(3): 208-1.

    A 70yearold man with upper respiratory tract infection was administered with intravenous infusion of levofloxacin 0.2 g twice daily and oral Shuanghuanglian solution 10 ml thrice daily. After the third infusion of levofloxacin, the man experienced pain of finger joints. And after the fifth infusion of levofloxacin, his painful swelling of finger joints worsened, and wrist, shoulder, elbow, and knee joints were involved; skin rash occurred. Laboratory investigations revealed the following levels: ALT 1 705 U/L, AST 754 U/L. Levofloxacin was withdrawn, and he received liverprotective and symptomatic treatment. One week later, his painful swelling of joints and skin rash resolved, his ALT level was 80 U/L, and his AST level returned to normal range.

  • 调查研究
    Zhao Jinhe;Qiu Zhihong
    . 2000, 2(3): 164-166.
    Objective: To determine the effect of clozapine on ECG of patients. Methods: 260 clozapine-treated inpatients were randomly enrolled for ECG analysis. Results: Abnormal changes of ECG were observed in 162 cases (62.31 % ) and 94.12 % of the remarkable changes could be returned to normal after a decrease or stop of clozapine taken. Conclusion: Clozapine could lead to abnormal ECG to a high degree. Most of the cases would be back to normal state of ECG when the above-mentioned step was started.
  • 安全用药
    . 2003, 5(5): 312-313.
    本文着重介绍喹诺酮类药物的心脏毒性,以引起医务人员的警觉。喹诺酮类药物的心脏毒性主要表现为心律紊乱和QT间期延长,其发生频率随药物品种不同而异,司帕沙星和格帕沙星对心脏毒性大于其他同类药物,并有剂量依赖性。喹诺酮类药物引起心脏毒性的机制尚不清楚。提醒医生须合理应用喹诺酮类药物,严重心血管疾病者、心律失常患者、老年患者、电解质失调者应慎用此类药物。
  • 临床论著
    Liu Yan;Zhang Jian
    . 2010, 12(4): 240-6.
    Objective: To investigate the effects of cytochrome P450 (CYP) 2C9 gene polymorphisms and age in Chinese Han patients on warfarin dose in order to benefit warfarin dose adjustment. Methods:Between April 2008 and March 2009, 161 inpatients at stabilized status on warfarin therapy from Beijing Friendship Hospital of Capital Medical University entered the study. The patients were divided into the following two groups: the elderly group and the adult group. The elderly group comprised 55 male patients and 45 female patients with average age of (72±6) years. The adult group comprised 34 male patients and 27 female patients with average age of (49±8) years. Warfarin dose, International Normalized Ratio (INR), cases of overanticoagulation and bleeding, the duration of warfarin treatment achieving the steady doseeffect relationship were recorded. The CYP2C9 gene types in patients in both groups were measured using ABI 3700 DNA sequencer. Maintenance dose of warfarin, the incidence of overanticoagulation in the initiatial period of warfarin treatment, the incidence of bleeding, the time achieving the steady doseeffect relationship were compared between patients with different genotypes and ages. Results:There were no significant differences in distribution of CYP2C9 AA and AC genotypes between the adult and elderly groups (P>0.05). The maintenance doses of warfarin were markedly lower in patients with AC genotype than in those with AA genotype [(2.40±0.96) mg vs (2.73±0.65) mg, P<0.01]; the warfarin maintenance dose in patients with AA and AC genotypes were markedly lower in the elderly group than in the adult group[(2.47±0.48) mg vs (3.24±0.85) mg,(2.08±0.71) mg vs (2.72±1.04) mg, both P<0.01]. During the initiatial period of warfarin treatment, the incidence rate of overanticoagulation was markedly higher in patients with AC genotype than in those with AA genotype (35.0% vs 5.7%, P<0.01); the incidence rate of overanticoagulation in patients with AA genotype was markedly higher in the elderly group than in the adult group (9.3% vs 0, P<0.05). The incidence rate of bleeding was markedly higher in patients with AC genotype than in those with AA genotype (30.0% vs 5.0%, P<0.05); the incidence rate of bleeding in patients with AA genotype was markedly higher in the elderly group than in the adult group (8.1% vs 0, P<0.05). The time achieving stable doseeffect relationship was markedly longer in patients with AC genotype than in those with AA genotype[(21.4±3.2)d vs (10.0±3.5)d, P<0.01]; there was no statistically significant difference in the patients with same genotype between the elderly group and the adult group. Conclusion:The CYP2C9 gene polymorphisms and age in Han Chinese patients can affect warfarin dose. The result from a measurement of CYP2C9 gene polymorphism could be used as a basis for warfarin dose adjustment.
  • ZHAN Mei;YIN Xi;XU Ting
    . 2013, 15(6): 314-6.
    ObjectiveTo evaluate the efficacy and safety of dipeptidyl-peptidase Ⅳ (DPP-4) inhibitors for treatment of type 2 diabetes mellitus.MethodsThe Cochrane Library, PubMed, Embase, Science Citation Index, the Chinese Journal Full-text Database, Chinese Scientific and Technical Periodicals Database, Chinese Biomedical Literature Database, and Wanfang Database were searched from the inception to August 2013. The key words were sitagliptin, vildagliptin, saxagliptin, linagliptin, alogliptin, dipeptidyl-peptidase Ⅳ, systematic reviews, and meta-analysis. According to the inclusion and exclusion criteria, articles for systematic reviews and meta-analysis were selected. Their methodological qualities were evaluated using QQAQ scale and the data were analyzed using descriptive analysis. The main outcomes included the changes in hemoglobin A1c (HbA1c) and homeostasis model assessment of β-cell index (HOMA-β) and incidence of adverse events.ResultsA total of 18 articles were entered in this study. Of them, scores of methodological quality in 89 percent of articles (16 articles) were 6.0-7.0. The effects of DPP-4 inhibitors on HbA1c levels in patients with type 2 diabetes mellitus were evaluated in thirteen articles. The effects of sitagliptin, vildagliptin, saxagliptin, and linagliptin on HbA1c reduction were better than those of the placeboes, but the conclusions were controversial with other oral hypoglycemic drugs. The effects of DPP-4 inhibitors on HOMA-β levels in patients with type 2 diabetes mellitus were evaluated in five articles. Sitagliptin, vildagliptin, and saxagliptin could significantly improve HOMA-β levels compared with the placeboes. The effect of sitagliptin on HOMA-β level improvement was not better than other oral antidiabetic drugs. The incidences of adverse events during the DPP-4 treatments were evaluated in 14 articles. The differences in the incidences of adverse events and hypoglycemia between the treatments with sitagliptin, vildagliptin, saxagliptin, linagliptin and the placeboes were not statistically significant. The incidences of hypoglycemia in treatment with sitagliptin and vidagliptin were lower than those with other oral hypoglycemic drugs. ConclusionDPP-4 inhibitors could control effectively the blood glucose in patients with type 2 diabetes mellitus and the short-term safety was good.
  • Zeng Jiantao, Li Quan
    . 2016, 18(2): 142.
    A 67-year-old man with acute gangrenous appendicitis received intravenous infusion of ceftriaxone sodium (2 g once every 12 hours ) and ornidazole (0.5 g once every 12 hours) after emergency appendectomy. Three days later, antibiotics were changed to piperacillin sodium and tazobactam sodium (4.5 g once every 8 hours by intravenous infusion) based on the results of drug sensitivity. His platelet count (PLT) was 288×109/L before the operation, 308×109/L on the second day and 1 128×109/L on the 12th day of piperacillin sodium and tazobactam sodium treatment. The examination of bone marrow smear showed hyperplasia of bone marrow. Thrombocytosis was considered to be related to piperacillin sodium and tazobactam sodium. piperacillin sodium and tazobactam sodium was withdrawn and cefoperazone sulbactam sodium (3 g once every 12 hours by intravenous infusion) was given. After 9 days of treatment, his platelet count decreased to 360×109/L. Fifteen days later, his platelet count was 332×109/L.
  • . 2017, 19(6): 401.
  • Li Ying, Du Liping, Li Lingling, Mei Dan
    . 2017, 19(2): 121-125.
    A variety of medications can lead to weight change. Overweight are risk factors for cardiovascular diseases. Weight gain was associated with the use of glucocorticoids, insulinsecretagogues, thiazolidinediones, atypical antipsychotics, valproate, lamotrigine, antidepressants and H1-receptor antagonist. Weight loss was associated with the use of metformin, glucagon-like peptide-1 receptor agonist, alpha-glucosidase inhibitors, zonisamide, topiramate, fluoxetine and bupropion. Weight change reduces medication adherence and influences the treatment of primary disease. Clinicians should balance the advantages and disadvantages and strengthen the patients′ medical education to reduce the drug adverse effect on the body weight.
  • Tang Lian, Wang Sannan, Weng Xiaohong, Shang Erning
    . 2016, 18(2): 99.
    ObjectiveTo analyze the clinical efficacy of linezolid, the influence of linezolid on PLT and risk factors for treatment of neonatal septicemia.MethodsThe medical record data of  neonates, who received the treatment with linezolid, diagnosed as late onset gram positive bacterial sepsis, and hospitalized in Department of Neonatology, Suzhou Municipal Hospital from June 2009 to May 2015, were collected. The  infants′ sex, age in days when medication was applied, body weight when they were born, gestational weeks at birth, diagnosis and complications, course of treatment, combined antimicrobial agents, results of pathogenic bacterial culture and laboratory examination before and after treatment, and the prognosis were recorded. Linezolid's clinical efficacy, bacteriological efficacy, and the influence on PLT in  infants were analyzed. The risk factors of linezolid related thrombocytopenia were analyzed by single and multi factor Logistics regression analysis.ResultsA total of  195 infants were enrolled in the study. Of them, 109 were boys and 86 were girls with age in days when medication from 8 to 28 days and an average age in days was (16±8) days, gestational weeks at birth from 27 to 42 weeks and average gestational weeks was (33±3) weeks, time of medication from 7 to 23 days and an average time was (12±4) days. Of the 195 infants, 133 (68.21%) were premature babies and 96 (49.23%) were used of other antimicrobial agents  at the same time. The results of evaluation of clinical efficacy showed the recovery were 117 cases(60.00%), excellence were 58 cases(29.74%). The total effective rate was 89.74%. There were 208 bacterial strain of gram-positive bacteria and 18 of gram-negative bacteria in 195 infants. The results of bacteriological efficacy showed the bacteria eradication were 178 cases(91.28%), partial removal of bacteria were 11 cases (5.64%), bacteria not cleared were 3 (1.54%) cases, and bacterial substitution were 3  (1.54%) cases. The bacterial eradication rate was 96.92%. There were 27 cases appeared  PLT decreasing on 5 to 15 days of medication [an average days of (9±5)d] in 195 infants. Of them, 22 cases (81.48%) were  premature, 19 infants with normal PLT baseline developed thrombocytopenia inⅠ,Ⅱ,Ⅲ and Ⅳdegree were 8,7,4 and 0 cases, respectively. Six cases appeared the decreasing of hemoglobin (>50% of baseline). Eight infants with thrombocytopeniaⅠdegree baseline developed to Ⅱ,Ⅲ and Ⅳdegree were 5,1, and 2 cases, respectively. Two cases appeared the decreasing of hemoglobin (>50% of baseline ). Linezolid was withdrawn immediately in 27 infants who developed thrombocytopenia. Of them, 19 cases PLT returned to normal by themselves on 3 to 13 day [an average time was (5±4) days] of drug withdrawal , and two cases discharged according to their parents, PLT in 6 cases returned to normal after receiving the symptomatic treatment. The results of Logistics regression analysis showed that body weight when they were born, gestational weeks at birth, baseline levels of PLT, albumin and total bilirubin were related to thrombocytopenia due to linezolid, gestational weeks at birth, baseline levels of PLT, albumin and total bilirubin were  independent risk factors of thrombocytopenia due to linezolid. ConclusionsLinezolid has a good efficacy in treatment of neonatal gram-positive bacterial sepsis.  The risk of thrombocytopenia due to linezolid may be increased when the infants receiving linezolid who with premature birth, or lower PLT baseline, or hypoproteinemia  or hyperbilirubinemia.
  • . 2013, 15(6): 304-2.
  • 论著
    LONG Xin;SUN Cheng-ye;XIE Li-jing;WANG Ying-wei;LIU Bing
    . 2013, 15(1): 11-6.

    ObjectiveTo evaluate the efficiency of the three molecular marker techniques for identification of plant genus in order to select the most suitable molecular technique to rapidly identify a poisonous plant at the scene of the poisoning accident.MethodsNineteen samples of leaves in 18 species of common poisonous plants of Ranunculaceae and Euphorbiaceaec were selected. Genomic DNA of these samples were extracted using improved hexadecyltrimethylammonium bromide (CTAB) method, species identification (genus level) were performed using random amplified polymorphic DNA (RAPD), inter-simple sequences repeats (ISSR) and DNA barcoding, cluster analysis were performed using NYSTS, SPSS, PAUP, and MEGA software. Accuracy, reliability, timeliness, and operability were compared between the 3 molecular marker techniques.ResultsAccuracy: genus level of samples failed to be identified using RAPD; and the accuracy rates in genus level of identification using ISSR and DNA barcoding were 68% and 100%, respectively. Reliability: the subjective influence rates and the repetitive rates in RAPD and ISSR were 47% and 26% as well as 47% and 45%, respectively; the success rates of amplification and sequencing of trnH-psbA fragment using DNA barcoding both were 100%. Timeliness: the time from extraction of DNA to accomplishment of identification in the 3 molecular marker techniques were 8.5, 9.0, and 42.2 h, respectively. Operability: species identification using RAPD and ISSR could be done in a common laboratory; special sequencing equipment was needed when using DNA barcoding technique in the identification of poisonous plants.ConclusionThe preliminary study results show that DNA barcoding is a molecular identification technique more suitable for rapid determination of the poisonous plant at the scene of the sudden poisoning accident.

  • 安全用药
    Liu Rong;Zhang Haiying
    . 2010, 12(6): 406-4.
    Quinolones are synthetic broadspectrum antibiotics. With the widespread use of quinolone, the case reports about achilles tendon injury are increasing. The common medicines causing achilles tendon injury include ciprofloxacin, norfloxacin, gatifloxacin, enoxacin, moxifloxacin, and levofloxacin. The mechanisms of quinoloneinduced achilles tendon injury may be related to cell damage, local magnesium deficiency and tissue necrosis. The major clinical manifestations of achilles tendon injury are unilateral or bilateral achilles tendon pain and inflammatory edema, and in severe cases achilles tendon rupture may occur. According to the report, the average time to achilles tendon injury onset is six days after drug start and the average time to recovery is fourteen days after drug discontinuation. The most common risk factors for achilles tendon injury are concomitant corticosteroid therapy, renal insufficiency, advanced age, hyperthroidism, diuretic use, peripheral vascular diseases, rheumatoid arthritis, diabetes mellitus, and strenous sports activity. Once symptoms associated with achilles tendon injury occur, the drug should be withdrawn immediately, activities should be stopped, and corticosteroids can be given for relieving swelling and pain. Quinolonesinduced achilles tendon injury can lead to serious consequences. Therefore, indiscriminate use of qinolones should be avoided and the drugs should be used with caution in patients with risk factors.
  • 安全用药
    Gao Chen;Zhou Ying
    . 2011, 13(4): 236-4.

    Ceftriaxone is a third generation cephalosporin, and it has a broad-spectrum antimicrobial activity. Ceftriaxone readily forms a precipitate of calcium-ceftriaxone salt with calcium in bile and urine, and this results in formation of pseudostone. Most patients with ceftriaxone-associated pseudolithiasis are asymptomatic. Ultrasonography is the most usual method for the diagnosis of ceftriaxone-associated pseudostone. Review of medical history and drug usage is helpful for an accurate diagnosis. The main risk factors for ceftriaxone-associated pseudolithiasis development include dosage, duration of treatment, rate of intravenous infusion, fasting, and dehydration. Ceftriaxone-associated pseudolithiasis is reversible and resolves spontaneously after drug withdrawal, there is no

    need for any operations. Symptomatic treatment should be given, if necessary.

  • 调查研究
    Wang Huimin①;Lian Hongxing①;Xu Jijun①;Li Haishan②;Chen Xinzhi③
    . 2003, 5(6): 371-374.
    Objective: To study the alleviative effects of silibinin(SB), one of the flavonoid chemicals, on the cardiac toxicity to mouse, which was caused by doxorubicin(Dox). Method: Compared with the Kunming mice treated with Dox, the content changes of blood serum creatine kinase(CK), aspartate aminotransferase (AST)and cardiac MDA were determined in mice by administration of both Dox and SB. Results: SB could antagnize the activity increasing of CK and AST which was caused by Dox, and significantly lower the level of MDA in heart. Conclusion: SB can reduce the formation of lipid peroxiation, thus alleviating cardiac toxicity markedly.
  • 中药不良反应
    Zhang Ji①;Chen Nian②;Li Shuang②;Ou Ning①
    . 2007, 9(6): 445-446.
    A 15-year-old boy with eczema was treated with Kunmingshanghaitang one tablet thrice daily.Twenty days later,his regimen was added to ebastine 10 mg once daily.One week later,he developed a fever of 39.8 ℃,skin rash with desquamation,yellowing of sclera,and hepatomegaly with tenderness.Laboratory tests revealed the following values:ALT 440.5 U/L,AST 809.7 U/L,CRP 10.8 mg/L,IgG 10.9 g/L,IgA 1.8 g/L,IgM 1.7 g/L,C3 0.61 g/L,and C4 0.069 7 g/L.He was treated with methylprednisolon and symptomatic therapy.Two weeks later,his skin damage improved,and all values of laboratory tests returned to normal ranges.
  • Yang Xinyuna;Zhong Shuqingb; Xiao Litinga
    Adverse Drug Reactions Journal. 2009, 11(5): 373-2.
    A 52yearold man with pneumonitis complicated by hydrothorax received combination therapy with cefuroxime and clindamycin for 3 days and then an IV infusion of cefoperazonesulbactam for 3 days. On day 7, cefoperazonesulbactam was stopped and switched to an IV infusion of vancomycin 0.5 g thrice daily due to poor efficacy. After further 10 days, the patient developed fever and his temperature was 40.2℃.The routine blood testing revealed following values: WBC count 2.7×109/L and neutrophil count 1.8×109/L. Vancomycin was stopped and changed to an IV infusion of meropenem 0.5 g thrice daily. Meanwhile symptomatic therapy was given. Two days later, his routine blood testing normalized.
  • 国外信息
    . 2005, 7(1): 70-72.
  • 调查研究
    Wang Yong;Peng Chenghong
    . 2002, 4(1): 9-11.
    Objective: To discuss the safe dosage of octreotide given through hepatic artery. Method: 18 cases who accepted radical excision of liver cancer were given drugs through hepatic artery pump. The first day's dosages were octreotide 200μg, suspension of CDDP and lipiodol 18ml (CDDP 40mg and superliquefied lipiodol 10ml), and the following day only octreotide 200fig. The remedy repeated every 4-8 weeks. Their vital signs, general condition, and routine laboratory examination were observed before and after the administration of drugs. Results: The adverse reactions were mostly symptoms of alimentary tract: nausea and vomiting (66.67%), anorexia (77.78%), constipation (27.78%), abdominal distention (72.22%), pain in right hypochondria! region (61.11%), facial hectic fever (88.89%, among them 55.56 % suffered hectic fever of whole body), palpitation (22.22%), hepatic function disorder (77.78%), thrombocytopenia and decreased PT (5.56%), transient fever (16.67%), paralytic ileus (5.56%) . Any transparent problems of myocardium and renal function didn't be found. Conclusion: 1.Administration of octreotide 200fμg through hepatic artery is safe. 2.Facial hectic fever or whole body hectic fever seems to be the only and transient body reaction to octreotide given through artery. 3. It is needed to be further confirmed whether octreotide is helpful to the prevention of relapse and metastasis after radical excision of liver cancer.
  • 中毒救治
    . 2002, 4(1): 29-31.
  • 病例报告
    Li Yancui;Hou Daping;Lei Lili;Jing Hongying
    . 2009, 11(2): 139-1.
    A 68yearold woman with diabetic retinopathy received 5 ml of IV fluorescein sodium 1% as an allergy test for ocular fundus angiography. Three minutes after injection, the woman developed dyspnoea and unconsciousness. His BP was 40/20 mmHg. She experienced one minute of cardiac arrest. The patient was administered with IM promethazine 50 mg, IM dexamethasone 10 mg, and IM adrenaline 1 mg, immediately. Subsequently, an examination revealed a pulse rate of 124 beats/min and a BP of 147/81 mmHg. The patient was in a coma vigil. After 175 days of hospitalization, she was discharged with a coma vigil.
  • 临床论著
    Wang Zhiying;Liang Biyun;Fu Zhuo
    . 2009, 11(3): 170-4.
    Objective: To observe the influence of atropine on anesthetic effect and safety of propofol during enteroscopy.Methods: Between March 2008 and July 2008, eighty patients planning to undergo enteroscopy were enrolled in the study and divided into two groups: the test group and the control group (40 cases in each group).The test group comprised 23 men and 17 women with average age (53±19) years. The control group comprised 26 men and 14 women with average age ( 50±22) years. The patients in the test group received an slow IV push of 0.250.5 ml of atropine 0.1mg/ml diluted in sodium chloride 0.9% to total of 5 ml, and slow IV push of propofol 1.52.5 mg/kg in not less than 30 seconds.The patients in the control group received propofol alone, the dosage and administration were the same as those in the test group.The patients’heart rate, blood pressure, and blood oxygen saturation before and 5, 10 minutes after administration, limb movement, period of consciousness, dosage of propofol, and adverse reactions were observed and recorded. Results:The heart rate of patients in both groups decreased 5 minutes after administration compared with before administration: (77.2±8.9) beats/min vs (73.5±9.1) beats/min, respectively, in the test group; (79.7±7.2) beats/min vs (68.4±12.3) beats/min, respectively, in the control group. The different in heart rate was statistically significant (all P<0.01). The systolic pressure and blood oxygen saturation in both groups decreased 5 minutes after drug administration compared with before drug administration: (136±12.5) mm Hg vs (123.2±14.3) mm Hg and (97.5±0.8)% vs (95.2±0.7)%, respectively, in the test group; (138±14.6) mm Hg vs (108±12.2) mm Hg and (97.8±0.7)% vs (90.3±0.8)%, respectively, in the control group. Systolic pressure and blood oxygen saturation markedly decreased in the control group compared with the test group, the differences were statistically significant (all P < 0.01). In the test and control groups, the total scores of limb movement was 22 and 46, the consciousness period was (2.8±1.3) min and (4.8±2.1) min, and the total dosage of propofol was (124±16) mg and (138±20) mg, respectively; the differences between the two groups were statistically significant (all P < 001). The incidence of adverse reactions in the test and control groups were 65% and 87.5%, respectively, including blood oxygen saturation <80% (2.5% vs 10.0%), bradycardia (0% vs 12.5%), and allergic erythema (7.5% vs 12.5%). Conclusion: Propofol combined with atropine is an effective and safe anesthetic regimen for painless enteroscopy.
  • Han Zhongling, Wu Jianhua, Xue Yufeng, Yang Li, Zheng Haiyan, Yang Jing, Teng Liang
    Adverse Drug Reactions Journal. 2022, 24(1): 24-29. https://doi.org/10.3760/cma.j.cn114015-20210601-00624
    Objective To explore the impact of adverse drug events (ADE) on readmission in renal transplant recipients and survival of the transplanted kidney. Methods The hospital information system was searched and medical records of patients who underwent renal transplantation in Beijing Road Medical Area of Xinjiang Military Region General Hospital from January 2008 to December 2018 and were re-admitted at least once (as of December 2020) were collected and analyzed retrospectively. Patient information such as gender, age, weight, ethnicity, kidney transplantation status, postoperative immunosuppressive treatment plan, readmission status, and kidney transplant survival time was extracted and the ADE signals were detected through reviewing the patient re-admission medical history using a self-established global trigger tool. The correlation between ADE and readmission was evaluated by Karch and Lasagna method; patients were included in the ADE-related readmission group (ADE admission group) and the non-ADE- related readmission group (non-ADE admission group) based on the correlation results. The clinical characteris- tics and the cumulative survival rate of kidney transplants between the 2 groups were compared. Results A total of 198 patients (1-426 times of readmission) were entered in the analysis, including 154 males and 44 females with an age of 14-62 years, and 118(59.6%) were Han nationality. The immunosuppressive drugs included cyclosporine, tacrolimus, sirolimus, etc. After renal transplantation, 240 times of readmission (16.8%) in 94 patients (47.5%) were associated with ADE. In the ADE readmission group, the number of diagnosed diseases and postoperative readmission times were more and the length of hospital stay was longer than those in the non-ADE readmission group [4 (3,6) vs. 3 (2,5), P=0.001; 6(3, 9) times vs. 4 (2, 8) times, P=0.022; 20(13, 33) days vs. 14 (11, 25) days, P=0.010]. Kaplan-Meier curve showed that the 1-, 3-, 5-, and 10-year cumulative survival rates of kidney transplants were 90.1%, 84.1%, 79.0%, and 57.6% in ADE- related readmission group, which were 99.0%, 94.7%, 90.8%, and 80.4% in non-ADE-related readmission, and the difference was statistically significant (P=0.001). Conclusions ADE can increase the readmission times, prolong the length of hospital stay, and reduce the cumulative survival rate of kidney transplants. The monitoring of ADE in renal transplant recipients should be strengthened.
  • Zhang Juan, Wang Yinglin, Zhao Quan
    Adverse Drug Reactions Journal. 2022, 24(3): 157-159. https://doi.org/10.3760/cma.j.cn114015-20210518-00585
    A 44-year-old male patient with type 2 diabetic ketosis received intravenous injection of 3.375 g piperacillin sodium and tazobactam sodium once every 8 hours for urinary tract infection. The patient′s platelet count (PLT) was 288×109/L before treatment. After 5 days of treatment, the patient′s PLT increased to 729×109/L. Secondary thrombocytosis was diagnosed, which was considered to be related to piperacillin sodium and tazobactam sodium. The drug was stopped and replaced by levofloxacin 0.5 g once daily orally. Five days later, the patient′s PLT decreased to 491×109/L; 14 days later, the PLT decreased to 280×109/L.
  • 安全合理用药
    Wang Mengran;Li Min
    . 2009, 11(1): 31-4.
    Rosiglitazone is a thiazolidinedione oral antidiabetic that improve insulin sensitivity and is used for the treatment of type 2 diabetes mellitus. In recent years, cardiovascular events associated with rosiglitazone cause concern. A meta analysis showed that in the rosiglitazone group, as compared with the control group, the odds ratio for myocardial infarction was 1.43 [95% confidence interval (CI) 1.03 to 1.98, P=0.03], and the odds ratio for cardiovascular death was 1.64 [95%CI 0.98 to 2.74, P=0.06]. The study has suggested that rosiglitazone may increase the risk of myocardial infarction and cardiovascular death. However, recently, an interim study of RECORD showed that 49 cases of myocardial infarction occurred in the rosiglitazone group, and 40 in the control group (P=0.34); congestive heart failure was 47 cases and 22cases in the rosiglitazone and the control groups, respectively (P=0.003). The study has suggested that rosiglitazone may not increase the risk of myocardial infarction and cardiovascular death, but may increase the risk of congestive heart failure. In addition, FDA issued a new Medication Guide and Prescribing information for rosiglitazone in 2008, and rosiglitazone is contraindicated in patients with severe heart failure. Therefore, the use of rosiglitazone should be based on balanced riskbenefit estimation and the dose should be individualized.
  • 论著
    Han Ming;Wu Yan;Sun Xianchang;Liu Rulin
    . 2008, 10(5): 0-0.

    Objective: To study the efficacy of ligustrazine in prevention of cisplatininduced ototoxicity . Methods: Eighty guinea pigs with normal hearing and the weight of 250~350 g were randomly divided into four groups (20 guinea pigs in each group): the normal saline group, the cisplatin group, the ligustrazine group, and the ligustrazine plus cisplatin group. The first three groups were intraperitoncally injected with normal saline 4 ml/kg daily, cisplatin 4 mg/kg daily, and ligustrazine 140 mg/kg daily, respectively. The fourth group was intraperitoncally injected with ligustrazine 140 mg/kg daily on day 1 and 2; and from day 3, cisplatin 4 mg/kg daily was given 30 minutes after ligustrazine administration for 6 days. Changes in auditory brain stem response (ABR) threshold were determined before medication and after the last medication. In addition, the SOD activity and malondialdehyde(MDA) content in the cochlea tissues of 10 guinea pigs in each group were measured and morphologic changes in cochlea hair cells of other 10 guinea pigs in each group were observed under transmission electron microscope after the last medication. Results: The ABR thresholds in the normal saline group, the cisplatin group, the ligustrazine group, and the ligustrazine plus cisplatin group were (55.652±6.562) dB, (40.556±4.532) dB, (42.321±5.362)dB, and (45.639±6.069) dB, respectively. The ABR thresholds in the cisplatin group were markedly higher than in the other three groups (P<0.01). The SOD activities in the normal saline group, the cisplatin group, and the ligustrazine plus cisplatin group were (33.30±5.89) U/mg, (21.44±6.42) U/mg, and (29.69±4.47) U/mg, respectively. The SOD acitivities in the cisplatin group were significantly lower than in the normal saline group (P<0.01). And there was no statistically significant difference in the SOD activities between the ligustrazine plus cisplatin group and the normal saline group (P>0.05). The MDA contents in the normal saline group, the cisplatin group, and the ligustrazine plus cisplatin group were (10.34±1.74) nmol/mg, (15.72±2.04) nmol/mg, and (11.07±1.56) nmol/mg, respectively. The MDA contents in the cisplatin group were significantly higher than in the normal saline group (P<0.01). And there was no statistically significant difference in the MDA contents between the ligustrazine plus cisplatin group and the normal saline group (P>0.05). The body and nucleus of hair cells remained basically normal in the ligustrazine plus cisplatin group, while the pyknosis, agglutination of nucleus chromatin, vacuolar degeneration, and the damage of ultra structure were marked in the cisplatin group.Conclusion:Ligustrazine has protective effects for cisplatininduced ototoxicity.

  • 病例报告
    Lu Mina;Zhou Yinga;Cui Yimina;Gao Yingb;Guo Xiaohuib
    . 2008, 10(3): 212-2.

    A 52year old woman with type Ⅱ diabetes mellitus initially treated with insulin aspart and subsequently insulin zinc protamine. About 3 months later, the regimen was changed to subcutaneous injection of insulin aspart 30 (dosage not stated). About one month later, skin rash and pruritus occurred at the injection sites. The skin disorders lasted from 2 to 3 hours, and then resolved. About further 2 months later, she presented with localized lipoatrophic areas (about 1~4 cm in diameter) at insulin aspart 30 injection sites on her forearm and abdomen. Insulin aspart 30 was discontinued, and switched to oral nateglinide 60 mg twice daily. One year later, her areas of lipoatrophy basically disappeared.

  • 病例报告
    . 2002, 4(1): 44-44.
  • 病例报告
    . 2005, 7(2): 128-129.
    A 78-year-old man got lumbago, edema for 9 years and cough, expectoration for 30 years, and was hospitalized with progressive severity of the symptoms for 5 days. He was diagnosed as coronary heart disease,chronic bronchitis, diabetes, and treated with anti-infection and symptomatic therapy. Several days later, he received allopurinol 100mg twice daily by mouth,because of high serum concentrations of uric acid. The patient developed chill, hyperpyrexia and fatigue after 9 consecutive days of administration. Physical examination revealed a temperature of 39.6℃ and lab findings included WBC 0.8×109/L with neutrophil 0.4. Aplastic anemia was approved on bone marrow puncture. Allopurinol was withdrawn immediately and the the symptoms were resolved.
  • 安全用药
    . 2005, 7(4): 263-267.
    众多新药的不断上市及老药新用增加了药物诱发风湿病的种类和发病率。根据近年文献研究报道,本文总结了易诱发风湿性疾病如系统性红斑狼疮/药物性狼疮、亚急性皮肤红斑狼疮、血管炎、硬皮病、肌炎的药物种类及疾病的临床特点和可能的致病机制,以便对这些药物诱发的风湿性疾病做出及时、准确的判断,从而有效防治药物诱发的风湿病。
  • Li Changqing, Ha Si, Liu Donghua,Cao Zhongchao
    . 2015, 17(3): 225.
    A 55-year-old man with hypertension, type 2 diabetes, abnormal liver function [alanine aminotransferase (ALT) 74 U/L, γ-glutamytransferase (γ-GT) 712 U/L)]and hypokalemia (3.40 mmol/L) received extended release nifedipine 30 mg once daily, benazepril 10 mg once daily, acarbose 25 mg three times a day before each meal, potassium chloride tablets 1.0 g three time daily, and an IV infusion of compound glycyrrhizin 60 ml (120 mg) once daily. On day 14 after administration the patient developed lower legs weakness and myalgia. The result of examination of animal force of limbs was Ⅳ level. The serum potassium was 1.1 mmol/L. Compound glycyrrhizin and benazepril were stopped. The patient was given potassium chloride tablets 2.0 g orally and an IV infusion of 10% potassium chloride 40 ml dissolved in more than 1 000 ml of 0.9% sodium chloride. The speed of IV infusion was 1.0 g  potassium chloride/hour. The serum potassium was 1.5 mmol/L four hours after drug withdrawal. The spirolactone 40 mg three times daily was added. Twenty four hours later, the patient′s serum potassium increased to 2.9 mmol/L, his symptom of myasthenia of limbs improved. Forty eight hours later, his serum potassium was 3.1 mmol/L, but he developed whole body myalgia, distending pain in both lower extremities and choking sensation in chest. Laboratory test showed creatine kinase(CK)50 940 U/L, CK-MB 441 U/L, lactate dehydrogenase (LDH) 1 992 U/L,aspartate aminotransferase (AST) 441 U/L, T (cTnT) 0.20 ng/ml,serum creatinine (SCr) 317 μmol/L,blood urine nitrogen (BUN) 18.2 mmol/L,uric acid (UA) 533 mol/L,and carban dioxide-combining Power (CO2-CP) 35.5 mmol/L. Myoglobins in blood and urine did not tested. The color of urine was dark brown. The patient was diagnosed severe hypokalemic,rhabdomyolysis,and renal injury. He received the symptomatic treatments of potassium supplement, fluid infusion, nutritional support, and protection of renal function. On day 5 of compound glycyrrhizin withdrawal, the laboratory test showed the following values: serum potassium 3.3 mmol/L, CK 10 292 U/L,Cr 252 μmo/L, BUN 16.3 mmol/L, UA 472 μmo/L;on day 10 of compound glycyrrhizin withdrawal, the laboratory test showed the following values: serum potassium 4.6 mmol/L, CK 107 U/L,Cr 116 μmo/L, BUN 6.4 mmol/L, UA 189 μmol/L. His blood pressure was maintained at 130-160/70-90 mmHg, and the symptoms of myasthenia of limbs, myalgia in whole body disappeared completely.
  • Tian Danli, Xu Yangui
    Adverse Drug Reactions Journal. 2021, 23(1): 6-9. https://doi.org/10.3760/cma.j.cn114015-20200731-000824
    The elderly are susceptible to a variety of diseases and the problem of multiple medications is common. Therefore, the rational use of medications in the elderly, especially the rational use of antibacterial drugs, is very important. The elderly have unique physiological and pathological characteristics. The decrease of immune function with aging and various factors such as malnutrition, primary disease, decreased mucosal barrier function, weakened cough reflex, and functional changes of the urinary tract system may increase the chance of infection in the elderly. Recommendations for the application of antibacterial drugs in the elderly include strictly grasping of the indications and selecting drug carefully, being alert to adverse drug-drug interactions, paying attention to the safety of drugs in new indications, and formulating individualized therapeutic regimen, etc. The irrational use of antibiotics not only increases the economic burden of patients, but also directly leads to the emergence of bacterial resistance. Clinicians should strictly grasp the indications of antibiotics, monitor the blood drug concentration as much as possible, formulate individualized drug administration plan, and pay attention to medication monitoring, so as to promote the medication safety in the elderly.
  • Shang Junmei, Liu Xin, Zhang Bo
    Adverse Drug Reactions Journal. 2021, 23(5): 247-251. https://doi.org/10.3760/cma.j.cn114015-20201230-01299
    Objective To explore the clinical features of dropped head syndrome(DHS) related to mitogen-activated extracellular signal regulated kinase inhibitors. Methods Case reports of dropped head syndrome caused by MEK inhibitors were collected by searching PubMed and Embase databases as of December 20, 2020. The following information of patients including gender, age, primary diseases, use of MEK inhibitors, occurrence time and clinical symptoms of DHS, and treatments and outcomes were extracted and analyzed descriptively. Results A total of 7 patients were entered; 4 from the United States, 2 from France, and 1 from Germany. There were 4 males and 3 females, aged from 56 to 76 years. The primary diseases were metastatic melanoma in 6 patients and Erdheim‐Chester disease in 1 patient. Of them, 3 patients were treated with selumetinib, 2 were with cobimetinib, and 1 was with binimetinib and trametinib respectively. Time from the first application of MEK inhibitors to the onset of DHS was from 0.5 to 20 months with a median time of 1 (1, 2) month. Major symptoms of DHS were neck pain, neck extensor weakness, and limited head lifting, which might be accompanied by neck stiffness in some patients. The pain on the neck could spread to the shoulders and occipital region, and a few patients might only have interscapular pain. At the time of diagnosis of DHS, the serum concentration of creatine kinase (CK) was elevated (150~1-011-U/L). After the diagnosis of DHS, 5 patients stopped taking MEK inhibitors and DHS symptoms were relieved or disappeared; 2 patients were treated with glucocorticoids for 1 to 4 weeks, but DHS symptoms were not relieved, then they stopped taking MEK inhibitors and DHS symptoms were improved. In total, the symptoms of DHS in the 7 patients were relieved after 14-30 days of MEK inhibitors withdrawal, with serum CK returning to within normal range. Three patients rechallenged MEK inhibitors with reduced doses; 1 patient had no recurrence of DHS and the remaining 2 patients had mild recurrences of DHS, which could resolve spontaneously or stay a stable condition. Conclusions DHS related to MEK inhibitors usually occurs within 1 month of medication, accompanied by an increase in CK level. The symptoms can be relieved or disappear after stopping medication in time and CK level will return to normal.
  • Sun Ying, Gu Yongli, Yang Guangsheng, Sun Zengxian
    Adverse Drug Reactions Journal. 2021, 23(5): 268-270. https://doi.org/10.3760/cma.j.cn114015-20201019-01054
    A 73-year-old male patient received immunotherapy (IV infusion of camrelizumab injection 200-mg once every 21 days) for mediastinal and right cervical lymph node metastasis after operation of esophageal cancer. Before immunotherapy, laboratory tests showed cardiac troponin I (cTnI) <0.01-μg/L, creatine kinase (CK) 69-U/L, and CK-MB 16-U/L。Electrocardiogram (ECG) showed no obvious abnormality. The day after the first IV infusion of camrelizumab, the patient developed fatigue, which were relieved without any treatment. The day after the second IV infusion of camrelizumab, he developed chest tightness, palpitation, and fatigue without obvious inducement. Laboratory tests showed cTnI 0.14-μg/L, CK 440-U/L, and CK-MB 39-U/L. ECG showed ST-T segment changes. Immune myocarditis due to camrelizumab was consi- dered. An IV infusion of methylprednisolone injection (60-500-mg/d) was given. After 16 days of treatment, the patient′s chest tightness and palpitations were improved. Laboratory tests showed cTnI 0.48-μg/L, CK 94-U/L, and CK-MB 37-U/L.
  • Adverse Drug Reactions Journal. 2020, 22(4): 272-272. https://doi.org/10.3760/cma.j.cn114015-20200423-00459
  • 病例报告
    Hu Yang;Qiu Lulu;Wang Lan;Zhang Bo
    . 2014, 16(5): 300-2.
    A 17-year-old woman with infectious endocarditis received an IV infusion of cefmetazole sodium 2 g three times daily and amikacin 0.4 g once daily. On day 6 of treatment, blood routine examination revealed the following levels: leucocyte count 23.4×109/L, neutrophile granulocyte 0.92,neutrophil granulocyte absolute value 21.6×109/L. On day 13 of treatment, blood routine examination revealed the following levels: leucocyte count 6.6×109/L, neutrophile granulocyte 0.70, neutrophil granulocyte absolute value 4.6×109/L. On day 14, amikacin was withdrawn and IV infusion of cefmetazole sodium was given at the original dose sequentially. On day 28 of treatment, blood routine examination revealed the following values: leucocyte count 2.6×109/L, neutrophile granulocyte 0.37,neutrophil granulocyte absolute value 1.0×109/L. Cefmetazole sodium was withdrawn and changed to an IV infusion of vancomycin 0.5 g every 8 hours. Seven days after replacement of drug, blood routine examination revealed the following: leucocyte count 6.1×109/L, neutrophile granulocyte 0.60,neutrophil granulocyte absolute value 3.7×109/L.
  • 病例报告
    Chen Zhidong;Hu Rongmei
    . 2007, 9(5): 372-372.
    An 80-year-old man with hypertension and renal disease was treated with lisinopril tablets 10 mg once daily,piperazine ferulate tablets 150 mg thrice daily,and coated aldehyde oxystarch granules 5 g twice daily.After 6 days of therapy,he developed a generalized skin rash with pruritus and a vesicular rash on his palms.After symptomatic therapy,the rashes disappeared.Then he ceased taking lisinopril and continued receiving piperazine ferulate tablets and coated aldehyde oxystarch granules.The symptoms did not reappear.
  • 滥用误用
    Zhang Junxia
    . 2009, 11(6): 425-427.
    A 44yearold man received Tusanqi(Senecio chrysanthemoides DC) 30g/d as a substitute for tea for eight weeks for leg pain and total doses were 1680g. After administration of Tusanqi the patient developed abdominal distension, asthenia, anorexia, dark urine, yellowish skin and sclera, and ascites. Liver function testing revealed the following levels and values: ALT 388.9U/L, AST 394.3 U/L, TBil 86.8 μmol/L, PTA 37.8%. Examinations showed intraabdominal infections. Gastroscopy revealed varicosity of oesophagus and gastric fundus. His abdominal CT scan showed evidence of hepatic venular occlusive disease. Antiinfective and symptomatic treatments were given. His liver function did not improve, intraabdominal infections was not controlled, and ascites did not subside. The patient was discharged voluntary.
  • 中药不良反应
    . 2007, 9(1): 56-57.
    Summary: A 50 year-old man with anorexia had taking 20 grain Chinese herbal medicine quisqalis fruit (Fructns Quisqualis) and drinking the infusion of quisqalis fruit skin instead of tea. Three days later, he developed symmetrical muscle pains and weakens, of limbs and trunk accompanied with elbows symmetrical erythma. Ten days later, the rash covered his limbs and trunk, and he also had dysphagia. Laboratory investigation showed CK 6 304 U/L and LDH 1 014 U/L.Electromyograpy revealed myogenic damage. A muscle biopsy showed increased nucleus of muscle cells, degenerative atrophy of the muscle fibres, and a lymphocyte and plasmocyte infiltration. Dermatomyositis was diagnosed. The patient's condition was improving after 3 weeks treatment with glucocorticoid and immunoglobulin.
  • 临床论著
    Xia Jinghong;Liu Haibo;Liu Shuang*;Wang Lingyan;Wang Wenjing
    . 2010, 12(4): 246-5.

    Objective: To discuss the occurrence and risk factors of antibacterialassociated diarrhea(AAD) in hospitalized patients in order to provide rational antibacterial use for reference. Methods: Between December 1, 2008 and November 30, 2009, the data of patients with diarrhea from Beijing Anzhen Hospital, Capital Medical University were collected. According to their medical history and stool tests, the patients were divided into two groups: the antibacterialassociated diarrhea group (the AAD group) and the nonantibacterialassociated diarrhea group (the nonAAD group). The clinical characteristics of patients, the situation of the antibacterial use, and the medical intervention measures were compared between the two groups; and the risk factors related to AAD were analyzed. Results: A total of 297 patients with diarrhea entered this study. The AAD group (n=194) comprised 101 male patients with average age of (69±14) years and 93 female patients with average age of (70±16) years. The nonAAD group (n=103) comprised 63 male patients with average age of (61±13) years and 40 female patients with average age of (65±12) years. The rates of patients with age of ≥60 years,number of ICU cases, ≥21 days of a hospital stay, number of a fasting regimen, receiving medical interventions and intensive nursing care,were more in the AAD group than in the nonAAD group.They were 81.4% (158 cases) vs 69.9%(72 cases),47.4% (92 cases) vs 35.9%(37 cases), 37.1%(72 cases) vs 19.4% (20 cases), 49.0% (95 cases) vs 33.0% (34 cases), 30.4% (59 cases) vs 14.6% (15 cases) and 43.3% (84 cases) vs 28.1% (29 cases),respectively (all P<0.05). The rates of patients receiving antibacterial treatment>14 days and /or ≥2 antibacterial agents combined were more in the AAD group than in the nonAAD group. They were 43.3% (84 cases) vs 20.4% (21 cases ),84.0% (163 cases) vs 53.4% (55 cases), respectively (all P<0.01). The antibacterial agents frequently implicated in AAD were cephalosporins, cephamycins, compoundlactamase inhibitors, carbapenems, quinolones, and lincomycin. There was no statistically significant difference in the prognoses between the two groups. The risk factors for AAD included age of ≥60, medical interventions, >14 days of antibacterial use, combined antibacterial therapy. Conclusion: Antibacterialassociated diarrhea is one of the common diarrhea in hospitalized patients. Therefore, long time antibacterials use and/or multiple antibacterial use should be avoided. Care should be taken in clinical use of antibacterial for the patients with advanced age, underlying diseases, and underlying fasting regimen and/or medical interventions.

  • BAI Yang;DAI Shan-shan;KONG Lei;LI Hong-mei;SUN Rui-fang
    ObjectiveTo analyze occurrence situation and improvement direction of drug dispensing errors at outpatient pharmacy.MethodsReports in non-punitive medication error reporting system at outpatient pharmacy of Civil Aviation General Hospital from February 2012 to January 2013 were collected. Cases of drug dispensing errors were selected and analyzed according to incidence, category, content, triggering cause, occurrence time, and drug classification of errors and persons who triggered or detected errors.ResultsOne hundred and thirty cases of drug dispensing errors were included. Error cases occurred mainly in February, July, and August and the incidences were 0.037%, 0.022%, and 0.034%, respectively. The incidence of drug dispensing errors in the whole year was 0.009%. Of the 130 cases, errors of category A, B, and C were respectively 4 cases (3.1%), 120 cases (92.3%), and 6 cases (4.6%). The persons who triggered errors of 126 cases of category B and C were respectively elementary pharmacists (108 cases), interns (13 cases), and intermediate pharmacists (5 cases). The persons who detected errors of 126 cases of category B and C were respectively intermediate pharmacists (95 cases), primary pharmacists (30 cases), nurses (2 cases), patients (2 cases), and senior pharmacist (1 case). The most common errors content was errors of drug varieties which accounted for 73.8%. Of the 130 cases, sound-alike drugs caused the most errors which accounted for 34.6%. The errors occurred mainly from 8∶00 to 10∶59 and from 13∶00 to 14∶59. Of 126 cases of category B and C, proportions of western medicine, Chinese patent medicine, high-risk drug, and narcotic drug were respectively 57.9% (73 cases, involving 129 kinds of drugs) , 38.1% (48 cases, involving 74 kinds of drugs), 3.2% (4 cases, involving 3 kinds of drugs) , and 0.8% (1 case, involving 2 kinds of drugs).ConclusionDrug dispensing errors could be prevented by renewing facility, managing drug location, optimizing work norm and procedure, strengthening education and training, and constructing culture of non-punitive drug safety.
  • 调查研究
    Qi Wenjie;Wang Hong;Ren Aimin;Zhang Lixia;Zhang Shuwen
    . 2005, 7(4): 252-256.
    Objective:To investigate the involed pathogens and their drug resistance in patients with acute infection. Methods: A retrospective study was performed of clinical data of the pathogens prevalence and the resistance to antimicrobial drugs in 85 patients with acute infection admitted to Beijing Friendship Hospital between 2002-2004. Results: Gram-negative bacteria were the main cause of infection, accounting for up to 50.0%, followed by Gram-positive bacteria(26.8%), and fungi (23.2%). Predominant Gram-negative bacteria included Enterobacter sp, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae and Acinetobacter. The Gram-positive bacteria included Staphylococci and Enterococci. Candida was the main cause of fungal infection. Vancomycin was active against Gram-positive cocci, which were resistante to penicillin in 66-100% of reslstance rate. A higher resistance to ampicillin was found among common Gram-negative bacteria, which were, however, lower resistance to tienam and sulperazone. After the treatment for 10 days , the resistance to antimicrobial drugs increased significantly in S. aureus, Escherichia coli and Enterobacter cloacae. Conclusion: Closely monitoring the pathogens prevalence , the resistance to antimicrobial drugs, and following rational antimicrobial therapy would provide an efficient measure for reducing the emergence of drug-resistant pathogens.
  • 专题讲座
    . 2001, 3(4): 274-277.
  • 论著
    Wang Huibinga;Zhang Jinpingb
    . 2008, 10(2): 86-3.

    Objective: To compare the damage of auricular vein and peripheral tissue caused by mannitol and β-aescine sodium in rabbits. Methods: Twelve healthy rabbits were randomly divided into three groups with 4 rabbits in each group: the mannitol group received 5 ml of mannitol 20% intravenously, the β-aescine sodium group received 5 ml of aescine sodium 0.02% intravenously, the control group received 5 ml of sodium chloride 0.9% intravenously. Each rabbit received two injections every day, ie, the left ear margin vein received the injection in the morning, and the right ear margin vein received the injection in the afternoon. The duration of medication was 3 days. The severity of damage on day 1 and day 3 and the degree of recovery on day 4~7 to the rabbits auricular vein and peripheral tissue were observed. Results: A pathological examination showed that on day 1, no marked changes in vascular and peripheral tissue of rabbit's ears were found in the mannitol and control groups, but vascular expansion and hemorrhage of rabbit's ears were found in the β-aescine sodium group. On day 3, the damage to vascular and peripheral tissue of rabbit's ears which were within 0.5 cm of the injection site was aggravated in the mannitol and β-aescine groups as follows: distruction of vascular endothelial cells, intravascular stasis and inflammatory edema of peripheral tissue occurred in the mannitol group; vascular expansion and inflammatory response occurred in the β-aescine sodium group; and no changes were found in the control group. On day 4, inflammation and edema to the peripheral tissue relieved in varying degrees in the mannitol and β-aescine sodium groups. However, on day 5 and day 7, a 1 cm×1 cm nercotic tissue which was 2 cm from the injection site, and a 0.6 cm×0.4 cm necrotic tissue which was 3.5 cm from the injection site occurred in two rabbits of the mannitol group, respectively. No necrotic tissue was found in the β-aescine sodium group. Conclusion: The appearance of damage caused by mannitol is later than that of β-aescine sodium. And severity of damage to the vascular and peripheral tissue caused by mannitol is more serious than that caused by β-aescine sodium.

  • 调查研究
    Zhao Yinga;Gao Linan;Shi Aixinb;Sun Fuchenga;Fu Dexingb
    . 2008, 10(3): 173-4.

    Objective: To discuss the clinical characteristics of shock induced by intravenous amiodarone in treating patients with atrial fibrillation. Methods: The clinical data of shock induced by intravenous amiodarone in treating patients with atrial fibrillation were collected from Chinese medical literature between 2003 and 2007, including the patients baseline heart diseases and the rhythm, heart rate, blood pressure, cardiac function status, and ECG changes during the period of atrial fibrillation attack. The concentration of fluid, delivery rate of intravenous infusion, and total dosage of amiodarone, and the manifestation, duration, and management of shock were analyzed. Results: The clinical data of seven patients with amiodaroneinduced shock were collected. Two of the 7 patients came from our hospital. Amiodarone was dissolved in 100 ml of glucose 5%, the concentration of amiodarone was 1.5~1.7 mg/ml, and the delivery rate was 2.5~1.0 mg/min by intravenous administration. The onset time of shock was within 2 minutes after medication in 4 cases, and from 5 to 20 minutes in 3 cases. The shock lasted from 3 to 120 minutes. Two patients accompanied with disturbance of consciousness, and five patients were still atrial fibrillation during the period of shock. Conclusion: The intravenous amiodarone might induce shock. The clinical condition is critical and it improves after immediate symptomatic treatment.

  • 安全合理用药
    Liu Long;Jing Baojie;Wu Lu
    . 2008, 10(4): 0-0.
    Terbinafine is an allylamine antifungal drug given by mouth in the treatment of fungal infections of the skin and nails. The common adverse reactions of terbinafine are gastrointestinal disturbances. However, there have also been rare cases of liver damage recently, sometimes leading to death. The mechanism of hepatotoxicity may be associated with inhibition of cytochrome CYP2D6 or direct toxicity of metabolite of terbinafine, allylic aldehyde. This papar has collected 40 reported cases of terbinafineinduced liver damage from the database of PubMed, Reactions, and CNKI. Of the 40 cases, 13 were male, 27 were female. Their age ranged from 24 to 75 years. The daily dosage of terbinafine was 250 mg. The time of liver damage onset was 5 days to 18 weeks after starting terbinafine therapy. The main clinical types were acute hepatocellular hepatitis, cholestatic hepatitis, and fulminant hepatitis. Of the 40 cases, 3 were hepatic failure, 2 were blood disorders, 1 was autoimmune hepatitis, and 1 was hepatic veno-occlusive disease and died after liver transplant. Treatment for terbinafineinduced liver damage includes corticosteroid therapy and liver transplant for severe patients. Before prescribing terbinafine, clinicians should be confident there is a clear indication for its use, and liver function should be assessed; during terbinafine therapy, close clinical observation and regular monitoring liver function should be performed.
  • 病例报告
    . 2004, 6(6): 406-407.
    A 33-year-old woman was hospitalized with somnolence and incoherent speech for 5 days. She was given thymic peptide 20mg by intramuscular injection daily in order to prevent SARS before the admission. Physical examination showed somnolence, inability of understanding, orientation and calculation, tendon hyperreflexia and positive Babinski reflex. MR showed multiple pathological changes throughout her periventricular and subcortical white matter. She was diagnosed as acute demyelinating disease and treated with prednisolone. Her condition improved after treatment. A 52-year-old man was hospitalized with numbness of right hand for 3 months and weakness of right limbs for 11 days. The patient was given thymic peptide 20mg by intramuscular injection once a week in order to prevent SARS. After the second administration, he had low fever, and the above-mentioned numbness and weakness occurred. MR showed large areas of T1 and T2 hyperintensity around ventricles of brain. He was diagnosed as multiple sclerosis, and his condition was improved after treatment.
  • 不良事件
    . 2005, 7(5): 388-388.
  • 调查研究
    CAI Haodong;MA Xiuyun;CUI Zhenyu
    . 2003, 5(5): 301-305.
    Objective:To evaluate the long-term efficacy and appropriate course of lamivudine for hepatitis B virus infec-tion.Method:Adults who were HBsAg,HBeAg,and HBV DNA positive were enrolled in this study.Lamivudine was given100mg daily for three years(156weeks)and its effects on HBV DNA,HBeAg,ALT and HBV mutation was observed.Re -sults:Lamivudine had an obvious inhibiting effect on HBV DNA,and was effective for keeping ALT normal.At the second year,virus mutation occurred in39.8%of patients,partly with rebound of HBV DNA level.The effects of lamivudine were associated with ALT and HBV DNA level of patients before treatment.It was safe with good tolerance and its adverse reac-tions were mild.Conclusion:Lamivudine is good for inhibiting replication of virus and maintenance of normal ALT.Patients with positive HBeAg and HBV DNA,lower DNA level and higher ALT level are the best candidates of lamivudine treatment.Its long-term effects for HBV infection are related to HBV mutation.
  • 病例报告
    Sun Yang①;Yuan Liping②
    . 2007, 9(5): 377-377.
    A 66-year-old man with transient ischemic attack was hospitalized for treatment.Batroxobin 10 BU by intravenous injection was added to his regimen for treating raised plasma fibrinogen.One hour after infusion,he developed perioral numbness and swelling.Ten hours later,he developed perioral diffuse swelling.Angioedema was diagnosed.After 5 hours of cetirizine treatment,his oedema resolved gradually.The next day,batroxobin was withdrawn,and the angioedema did not recur.
  • 病例报告
    Wei Qiuren
    . 2007, 9(6): 430-430.
    A 45-year-old woman with right papillitis and ischemic optic neuropathy received intraveous infusion of nimodipine 4 mg once daily.On day 15 after administration,her platelet count decreased from 256×109/L to 47×109/L,and then decreased to 32×109/L on day 28.Nimodipine was stopped and switched to intraveous infusion of cerebroprotein hydrolysate 30 mg once daily.Five days later,the patient' s platelet count returned to 174×109/L.
  • 论著
    Zhou Shuang;Sheng Xiaoyan;Xiang Qian;Zhao Liping;Zhou Ying;Cui Yimin
    . 2014, 16(6): 327-9.
    ObjectiveTo evaluate systematically the efficacy and safety of lispro insulin (LP) in patients with type 2 diabetes mellitus (T2DM)Methods"Type 2 diabetes mellitus", "lispro insulin", and "randomized controlled trail" were selected as the key words and Medline, Embase, PubMed, Cochrane library, CNKI, and WanFang Data were searched. The evaluation of methodological quality for the literature in accordance with inclusion criteria and Meta-analysis were performed. According to the intervention measures, the subjects were divided into the experimental group (treated with LP) and the control group [treated with biosynthetic human insulin (HI)]. All subjects in the 2 groups could be treated with other oral hypoglycemic drugs or insulin at the same time. The efficacy was evaluated using fasting blood-glucose, 2 h postprandial blood glucose, glycemic excursion, glycosylated hemoglobin, C-peptide, and cholesterol levels; the safety was evaluated using the incidence of hypoglycemia.ResultsA total of 25 literature were entered in this study and their quality evaluation results were 2 high quality articles, 9 medium quality, and 14 low quality. A total of 2 975 patients were entered in the study. The Meta-analysis showed the following results. The efficacy of LP treatment in patients with T2DM to decrease the fasting blood-glucose, 2 h postprandial blood glucose, glycosylated hemoglobin, and cholesterol were better than those of HI treatment (MD=-0.16, 95%CI:-0.27--0.06, P=0.00; MD=-1.38, 95%CI:-1.46--1.30, P=0.00; MD=-0.28, 95%CI:-0.33--0.24, P<0.00; MD=-0.26, 95%CI:-0.35--0.18, P=0.00). The differences of glycemic excursion and C-peptide changes in the experimental and the control groups were not significant statistically (MD=-0.51, 95%CI: -1.04-0.01, P=0.05; MD=-0.02, 95%CI:-0.26--0.22, P=0.88); the incidence of hypoglycaemia was lower in the experimental group than that in the control group (OR=0.53, 95%CI: 0.38-0.74, P=0.00).ConclusionLispro insulin is effective and safe in treatment in patients with T2DM.
  • 病例报告
    Wei Yanhong;Zhang Yatong;Wu Suowei
    . 2014, 16(2): 120-1.

    A 75-year-old male patient received regularly fluvastatin sodium 80 mg once daily after intracoronary stent implantation. The medication was changed to atorvastatin calcium 10 mg every night because his lipid levels could not reach the standard. On day 4, the patient′s insomnia became worse than before, he was awake all night. Atorvastatin calcium was stopped and rosuvastatin calcium 10 mg every night was given. Three days later, his insomnia was relieved.

  • Li Zhengrong, Wang Ling, Shi Zengcheng, Bao Yulin
    . 2016, 18(1): 26.
    ObjectiveTo explore the warfarin anti-coagulation effect and safety of clinical pharmacist-participated anticoagulation management service (AMS) on patients with atrial fibrillation after percutaneous balloon mitral valvuloplasty(PBMV).MethodsThe patients who underwent PBMV were divided into trial group and control group by random number table. The patients in the trial group received the clinical pharmacist-participated AMS. The clinical pharmacist provided adjusted warfarin dosage suggestion to clinician and warfarin anticoagulant education to the patients and their family members. The patients in the control group received warfarin following the visiting doctor′s advice. Anticoagulant effect indicators included international normalized ratio (INR) compliance rate, effective anticoagulation rate, anticoagulant deficiency rate and excessive anticoagulation rate. Safety evaluation indicators were embolism and bleeding events during the anticoagulant therapy.ResultsA total of 131 patients were enrolled in the study. The trial group comprised 68 and the control group 63 patients, respectively. The differences in the patients′ age, sex composition, body weight, smoking and drinking habits, degree of mitral stenosis, combined disease, baseline INR, and preliminary warfarin dosage after PBMV were not significant between the 2 groups (all P>0.05). The INR compliance rate in the trial group and the control group were  53.3% (217/407) and 41.8% (155/371), respectively (P=0.001); effective anticoagulation rates were  55.9% (38/68) and 33.3% (21/63), respectively (P=0.016); anticoagulant deficiency rate were 19.9% (81/407) and 27.8% (103/371), respectively (P=0.003); and the excessive anticoagulation rates were 7.9%(32/407) and 14.0%(52/371), respectively (P=0.006). There were 6 and 9 patients developed minor bleeding events and each was one slight embolism in the trial group and the control group, respectively. The incidence rate of adverse reactions in the trial group (10.3%) was lower than that in the control group (15.9%), but the difference was not significant.ConclusionThe clinical pharmacist-participated AMS may increase the INR compliance rate and the effective anticoagulation rate, decrease the anticoagulant deficiency rate and the excessive anticoagulation rate, and help to increase the effectiveness and safety of warfarin treatment in the patients with atrial fibrillation after PBMV.
  • Xing Yue, Dong Mei
    Adverse Drug Reactions Journal. 2022, 24(3): 113-115. https://doi.org/10.3760/c ma.j.cn114015-20220224-00150
    Immune checkpoint inhibitors (ICI) is a class of high-profile immunotherapy drugs for tumor, which has showed remarkable efficacy in the treatment of a variety of malignant tumors. However, ICI can also induce a series of immune-related adverse events (irAE), which are common in endocrine system with an incidence of about 40%. The irAE in endocrine system has obvious impacts on the efficacy of ICI for primary diseases and quality of life in patients, which may even be life-threatening. It is suggested that the diagnosis and treatment of irAE in endocrine system should be improved through further strengthening the research on the mechanism, diagnosis, and differential diagnosis of irAE, constructing multidisciplinary teams on diagnosis and treatment, and performing whole process management of tumor patients treated with ICI.
  • 病例报告
    Jiang Yan;Zhang Lei
    . 2014, 16(5): 314-3.
    An 61-year-old woman with fever received an IV infusion of moxifloxacin 0.4 g once daily. Seventy-four minutes after IV infusion, the patient stared at her right side, convulsions over the body, pallor, gnathospasmus, loss of consciousness and incontinentia urinae suddenly. Totally 3 paroxysmal attacks occurred, each persisted for 3-4 seconds in a minute. Electrocardiogram showed frequent ventricular premature beats, short array torsades de pointes ventricular tachycardia and ventricular flutter. Moxifloxacin was withdrawn immediately. She received an IV infusion of 0.9% sodium chloride injection 250 ml plus potassium chloride 0.7 g and magnesium sulfate 1.25 g. Forty-six minutes later the patient regained consciousness, electrocardiographic monitoring showed sinus rhythm and the premature beat disappeared. The patient had a history of 36 years of schizophrenia and took chlorpromazine 400 mg/d for long time. The patient′s fever disappeared after moxifloxacin and chlorpromazine withdrawal and receiving piperacillin sodium and sulbactam sodium, ceftazidime, and olanzapine successively. After that her torsades de pointes did not recur in twenty days of hospitalization.
  • 调查研究
    Zhang Yan;Zhu Haiying;Cheng Hongqin;Chu Yanqi;Yang Yiwei;Fu Qiang
    . 2009, 11(6): 406-4.

    Objective: To investigate the clinical features of neurotoxicity induced by cefepime use in patients with chronic renal failure in order to provide the basis for rational use of cefepime. Methods:In JanuaryApril 2009, 6 patients with chronic renal failure receiving cefepime were enrolled in the investigation. The time to neurological symptom onset, clinical presentations, and the time to the symptom relief were investigated. The liver and renal function, blood glucose, electrolyte, pH, pO2, and pCO2 levels were measured. Results: Six patients comprised 3 men and 3 women aged 54~92 years [avaergy age (74±13)]. All 6 patients received an IV infusion of cefepime 2~8 g daily for pulmonary infections.Neurological symptoms occurred in 1~3 days after initiation of cefepime infusion. Clinical presentations included agitation, verbal incoherence, delirium, confusion, somnolence, and 1 case of involuntary tremor of the extremities. The symptoms relieved within 3 days after cefepime discontinuation and symptomatic therapy. There was no marked difference in biochemical values in all 6 patients before and after cefipime administration. Conclusion: Neurotoxicity may occur in patients with chronic renal failure receiving an IV infusion of cefepime; care should be taken when using cefepime to treat patients with renal failure.

  • 中毒救治
    Wang Ying
    . 2007, 9(3): 194-194.
    A 42-year-old woman with arthralgia took adonisidum decoction (1ml is equivalent to adonisidum 2mg) 200ml twice daily for 2 days. She developed dizziness, palpitation, xanthopsia, nausea, and vomiting. After admission, an electrocardiographic monitoring revealed atrial flutter and atrioventricular block Ⅱ°to Ⅲ°. She was given oxygen and symptomatic therapy. On day 3, the patient’s ECG was normal.
  • 中药不良反应
    . 2007, 9(1): 57-57.
  • 病例报告
    . 2000, 2(1): 64-64.
  • 安全用药
    ZHANG Kai-gao
    . 2012, 14(1): 31-3.

    Opioids are the most widely used medications for managing moderate to severe clinical pain. During the past several years, sex differences in opioids adverse reactions including respiratory depression, gastrointestinal disorders, cardiovascular effects, analgesia tolerance and dependence have received increasing attention. Further study on sex differences in opioids adverse reactions will improve individualized therapies.

  • 论著
    Yu Zhiying;Gu Qun;Zhang Bin
    . 2011, 13(5): 294-7.

    Objective: To systematically compare and evaluate the efficacy and safety of parenteral iron preparation plus

    recombinant-human erythropoietin (rHuEPO),oral iron preparation plus rHuEPO, and rHuEPO alone in treatment of patients with

    chemotherapy-induced anemia (CIA). Methods: PubMed (from 1966 to April 2011), EMbase (from 1974 to April 2011), CBM (from

    1978 to April 2011), CNKI (from 1979 to April 2011), and Cochrane systematic evaluation and controlled trials register in

    Cochrane Library (from 1960 to Issue 1,2011) were searched using keywords “anemia”, “chemotherapy-induced anemia”,

    “ferrous sulfate”, “ferrous fumarate”, “sodium ferric gluconate complex”, “iron sucrose injection”, “iron dextran

    injection”, “recombinant-human erythropoietin”, “darbepoetin alfa”, and“epoetin alfa”. Randomized controlled trials

    (RCT) on the three different regimens in treatment of patients with CIA were collected. According to the inclusion criteria,

    the articles were selected and evaluated. All data were meta-analyzed using RevMan 5.0 software. After the patients received

    the three different regimens, the average value of haemoglobin (Hb) level changes, the effective rate, the blood transfusion

    rate, the incidence of adverse drug reactions (ADRs), and the average value of quality of life score changes were calculated.

    Results: A total of 106 related articles were searched and 6 RCT were selected according to the inclusion criteria. A total

    of 1294 patients were entered in this study. The results of meta-analysis showed that the differences in the average value of

    Hb level changes, the effective rate, the blood transfusion rate, the incidence of ADRs between the parenteral iron and oral

    iron regimens were not significant (all P>0.05). The weighed mean difference[95% confidence interval (CI) ]of the average

    value of Hb level changes between the parenteral iron and no iron regimens was 0.54 (0.16-0.91, P=0.005); the odds ratio (95%

    CI) of the effective rate and the blood transfusion rate between above 2 regimens were 2.07 (1.18-3.65, P=0.01)and 0.66

    (0.46-0.93, P=0.02), respectively. The differences were significant. Conclusion: Parenteral iron preparation plus rHuEPO

    could significantly increase the Hb level and effective rate, as well as decrease blood transfusion rate in the treatment of

    the patients with CIA, compared with use of rHuEPO alone, but in a comparison of parenteral iron preparation plus rHuEPO with

    oral iron preparation plus rHuEPO, there is no significant difference in the effectiveness of treatment.

  • 综合报道
    . 2001, 3(4): 237-240.
  • 综述
    . 1999, 1(2): 86-88.
    本文概述苯二氮(艹卓)类镇静催眠药的药物依赖性表现特征和形成因素;以及避免发生药物依赖性,正确合理使用苯二氮(艹卓)类药物的基本原则。
  • SARS防治
    . 2003, 5(4): 217-222.
    目的:研究SARS病人临床特征及其免疫发病机制和治疗。方法:52例确诊SARS病人,35例1周内入院者进行联合抗病毒治疗,17例在院外接受过大剂量糖皮质激素组1周以上者为对照,探索SARS治疗方法。检测病人不同阶段T淋巴细胞亚群、B细胞、NK细胞水平及血常规淋巴细胞计数,研究SARS病人免疫功能变化规律。结果:SARS病人69%具有双峰热型特点,病情演变呈阶段性,可分为四个时期:发热期、肺损伤期、免疫麻痹期、恢复期。早期以联合抗病毒治疗35例,重症3例,无1例死亡;早期大剂量应用糖皮质激素者17例,重症7例,死亡7例,死亡均与严重机会感染有关。SARS病人起病初即有T细胞、B细胞、NK细胞下降,在病程8~12天降至最低,普通病人第3周恢复正常,重型死亡病例持续低下。血常规淋巴细胞计数与流式细胞仪T细胞亚群直线相关,可代替后者观察病情。结论:SARS病人主要矛盾是免疫力低下,病毒直接杀伤淋巴细胞可能是其原因。早期联合抗病毒治疗有较好疗效,不宜应用大量糖皮质激素治疗。
  • 调查研究
    Mao Yonghui;Wang Haitao;Wang Songlan;Fang Fang;Wu Hua
    . 2006, 8(2): 109-112.
    Objective: To investigate the clinical characteristics and mechanism of renal failure due to acute hyperphosphatemia following intravenous fructose diphosphate injection. Methods: Five patients with renal failure due to acute hyperphosphatemia following intravenous fructose diphosphate were retrospectively studied. One patient underwent renal biopsy and the specimens were processed for pathological test. Results: Five patients had an elevation of serum phosphorus around 6.15-9.99mmol/L with polysystemic injury and acute renal failure or chronic renal function insufficient. The pathological finding showed that an acute tubular interstitial nephropathy with calcium deposit in tubular cavity and the wall of microvessels. Conclusion: Fructose diphosphate could cause severe hyperphosphatemia and adverse reactions in many systems especially in kidney. The mechanism of renal failure could be acute nephrocalcinosis.
  • 病例报告
    Wen Jing;Wen Zongping
    . 2008, 10(3): 209-1.

    An 87yearold woman with cerebral infarction and stress ulcer received intravenous injection of omeprazole 40 mg in 10 ml of sodium chloride 0.9%. Approximately 10 minutes later, the woman developed palpitation with a heart rate of 124 beats/min, and her ECG showed sinus tachycardia. Her symptoms resolved gradually after one hour. The next day, the abovementioned symptoms reappeared after repeated exposure to the same regimen, and relieved after one hour. Omeprazole was discontinued and changed to ranitidine. The abovementioned symptoms did not recur.

  • Zhang Haiying;Li Yuzhen
    Adverse Drug Reactions Journal. 2009, 11(6): 445-2.
    A 52yearold woman received gefitinib 250 mg once daily for adenocarcinoma of right lung. After 3 months of the therapy, the patient developed generalised itching with rash. Subsequently, the lesion was aggravated and she experienced perioral vesicles and dysphagia. Gefitinib was withdrawn and vitamin C and calcium gluconate were given, and then his skin sympotms improved.
  • 病例报告
    . 2004, 6(5): 331-332.
    A 30-year-old man was diagnosed as "myofascitis" and treated with celecoxib 200mg once daily. On day 3 he developed multiple skin lesions with pruritus and pain on his abdomen, and stopped celecoxib immediately. The skin rash was increased progressively and distributed over trunk, legs and arms, then feet and face. The skin lesions were expanded and partially fused. Then the patient was treated with intravenous infusion of dexamethasone 10mg daily. 3 days later,pruritus was decreased but skin pain was increased. Thenthe man was treated with intravenous infusion of 10% calcium gluconate 20ml plus lotion calamine for 3 days. Illness condition unimproved, he was admitted to hospital. He had a history of hypersensitivity to sulfadiazine during childhood. Physical examination revealed mouth ulcers. The man was given dexamethasone,& 10% calcium gluconate, erythromycin, ciprofloxacin, and antihistamines plus lotion calamine during hospitalization. 10 days later, the symptoms lessened; 40 days later, the skin rash resolved gradually.
  • 调查研究
    Yang Liming①;Jiang Yah①;Wang Liran②;Jin Fuhua①;Wang Xicha0①;Zhang Rui③
    . 2004, 6(4): 229-231.
    Objective: To study the treatment of rifampicin-induced acute interstitial nephritis(AIN). Methods: 29 cases with rifampicin-induced AIN, aged 25-59, were treated with individualized hemodialysis (or peritoneal dialysis) and drugs. Results: After the above-mentioned treatment, all patients improved considerably, that is, gradually symptoms resolved,urinary outflow increased and normalized, serum creatinine and blood urea nitrogen were lowered from 2091.3μmol/L and 55 mmol/L to normal respectively. Conclusion: The treatment with dialysis and drugs combination shows satisfactory effects on rifampicin-induced AIN.
  • Sun Shuzhena;Yang Dongpingb
    Adverse Drug Reactions Journal. 2009, 11(6): 419-2.
    A 36yearold woman, who underwent cesarean section, received an IV infusion of azithromycin 0.5 g+vitamin B6 200 mg in 5% glucose 500 ml for prevention of infections. Eight hours later, the patient experienced bilateral parotid swelling, mild pressing pain, and difficulty in opening mouth. Azithromycin was stopped and his symptoms subsided.
  • 病例报告
    Wu Cuifang;Liu Yulan;Jia Sujie
    . 2009, 11(5): 362-2.
    Two male and one female patients aged 17,30, and 14 years received chemotherapy with vincristine, pirarubicin, and predinisone for acute lymphocytic leukemia. On 1~2 cycles of therapy, the patients experienced symptoms such as numbness and muscle weakness in their extremities, inablity to completely extend their fingers, movement limitation of interphalangeal and metacarpophalangeal joints, and muscular atrophy in their limbs. After treatmeat with VitB1, VitB12, and mecobalamin, their symptoms sightly improved.
  • Chang Hongyua;Li Fanga;Nie Yalinga;Hou Qingxiangb;Zhang Hongc;Li Mand;Zeng Lia;Zhang Xiaa
    Adverse Drug Reactions Journal. 2010, 12(1): 42-3.
    A 53dayold female infant was hospitalized for somnolence and refusal to drink milk after she was given 2 drops of naphazoline nosal drops by parents themselves for nasal obstruction. On admission, physical examination showed a pulse of 80 beats/min, a respiratory rate of 30 breaths/min, depression, somnolence, pale face, low response, abnormal respiratory rhythm, peripheral coldness, weak primary reflection. Subsequently, she developed sobbing at long intervals, and her respiratory rate was 18~20 breaths/min. She was treated with oxygen inhalation, anisodamine, and naloxone. Six hours later, her symptoms improved and she recovered and was discharged after 3 days.
  • 病例报告
    Wu Huijin;Cui Yinhua;Wen Xiying
    . 2009, 11(4): 288-2.
    A 36yearold woman with suppurative tonsillitis received amoxicillin capsule 0.5 g. Five hours later, the patient developed abdominal pain, lumbago, accompanied by frequency and urgency of urination and painful micturition. Routine urine tests showed dark red turbid urine, RBC(++), WBC 1~2 cells/HP, protein(++). Amoxicillin was stopped and changed to penicillin. Two days later, her symptoms improved. Ten days later, a repeated routine urine test was normal.
  • 论著
    Meng Junhua;Li Xiaoying;Shao Limin;Wang Lei;Hao Jianling;Wang Hong
    . 2006, 8(1): 22-23.
    Objective: To observe the efficacy and safety of lipoprostaglandin E1 for diabetic peripheral neuropathy. Methods: 102 patients with diabetic peripheral neuropathy were randomly divided inte two groups. 50 patients in the treatment group were treated with lipoprostaglandin E1 10-20 μg/d while 52 patients in the control group were administered Xuesuantong 20 ml/d. Symptomatic improvement in peripheral neuropathy was compared between the two groups. Results: The percentages of patients improving in numbness pain dysesthesia and sensation of coldness were 91.1% 95% 86.6% and 84% respectively in the treatment group which were all higher than those in the control group(70% 72.1% 66.7% and 57.1% respectively)(p<0.05). No obvious adverse reactions were found in all patients. Conclusion: Treatment with poprostaglandin E1 is effective and safe for diabetic peripheral neuropathy.
  • 病例报告
    . 2006, 8(3): 196-196.
  • 综述
    . 2002, 4(1): 4-8.
    牙龈增生是牙周组织的异常增殖,常表现为疼痛,出血,咬合困难并影响美观。导致牙龈增生的因素是多方面的,其中药物引起的牙龈增生是不可忽视的因素之一,且日益为人们所关注。本文就近10年来钙拮抗剂、环孢素、抗癫痫类药物所致牙龈增生的临床表现,发病机制及其处理方法进行综述,旨在引起对药物致牙龈增生不良反应的重视。
  • 安全用药
    . 2002, 4(1): 20-22.
    本文介绍了亚胺培南/西司他丁钠致精神症状、癫痫发作及听视力下降等神经系统不良反应,并对其作用机制、影响因素及防治措施进行了探讨。
  • 综合报道
    . 2002, 4(2): 99-101.
    本文对医药期刊中关于奈福泮不良反应的散在报告进行了综合报道。奈福泮(平痛新)的不良反应主要涉及消化系统、神经系统、心血管系统及过敏反应,少见成瘾、过量中毒、呼吸停止、尿潴留等。医师使用本品时应注意患者选择,密切观察。
  • 病例报告
    Zhang Xiangyang;Wang Yuran;Ren Xiaolei;Zhu Jihong
    . 2011, 13(5): 308-3.

    A 81-year-old woman, who had hyperlipidemia and was treated with simvastatin 40 mg/d for the previous 1 year, received a single additional dose of ursodexoycholic acid 250 mg for her cholelithiasis. The next day, she presented with fatigue, generalized muscle ache and pain, and dark urine. On day 10, her creatine kinase (CK) level was 12 650 U/L. Rhabdomyolysis was diagnosed. The patient was treated with hydration, intravenous infusion of sodium bicarbonate and intermittent furosemide. During this period, her CK level peaked at 80 539U/L and CK-MB/CK level peaked at 7.4%. ubsequently, her symptoms and laboratory indices gradually returned to normal; she was discharged.

  • 论著
    Xi Chunhua;Wang Yanhua;Li Tianzuo
    . 2011, 13(3): 142-5.
    ABSTRACT Objective: To explore the effectiveness and safety of low-dose midazolam or ketamine on prevention of postoperative agitation induced by sevoflurane in non-hospitalized children. Methods: The children who underwent strabotomy under general anesthesia with sevoflurane entered a prospective randomized study.The children were divided into the midazolam group, the ketamine group and the control group by using ballot method. Anesthesia was induced with 8% sevoflurane and oxygen (5 L/min) via a face mask in all children. The laryngeal mask airway was inserted and the spontaneous respiration was maintained after the children became unconscious and jaw relaxed. Anesthesia was maintained with 2.0%-2.5% sevoflurane in an oxygen-nitrous oxide mixture. The children in the control,midazolam and ketamine groups were administered 0.9% sodium chloride 5 ml,midazolam 0.02 mg/kg (diluted with 0.9% sodium chloride to 5 ml), and ketamine 0.2 mg/kg (diluted with 0.9% sodium chloride to 5 ml) by slow intravenous push 10 minutes before the end of surgery, respectively. The laryngeal mask airway was removed, the children were transferred to the post anesthesia care unit(PACU) and the agitation was scored. If the child’s score was≥4, an IV push of propofol 2.0 mg/kg was given. The anesthesia time, recovery time from the anesthesia, the situation of postoperative agitation, whether receiving propofol, PACU length of stay, and the adverse reactions in children in the three groups were recorded. Results: A total of 61 children (aged 3-6 years, ASA physical status Ⅰ-Ⅱ)entered this study from May to November 2010.The control group comprised 11 boys and 9 girls with average age of (5.0±0.8) years and body weight of 14-27 kg; the midazolam group comprised 13 boys and 8 girls with average age of (5.0±0.4) years and body weight of 13-24 kg; the ketamine group comprised 10 boys and 10 girls with average age of (5.0±0.9) years and body weight of 15-30 kg. There were no statistically significant differences between the three groups in the gender, age, body weight, and the ratio of surgery for single or both eyes (P>0.05). The recovery time from the anesthesis in the midazolam and ketamine groups[(32.8±6.5) and (286±8.6) min, respectively]were longer than that in the control group[(19.8±5.0)min, P<0.01], the incidence of postoperative agitation in the midazolam and ketamine groups[19%(4/21), 15%(3/20)]were lower than that in the control group[55%(11/20), P<0.05]. No statistically significant differences were observed between the three groups in regards to anesthesia time, whether receiving propofol, PACU length of stay, and the adverse reactions (P>0.05). Conclusion: Low-dose midazolam or ketamine is safe and effective in preventing postoperative agitation induced by sevoflurane.
  • CAO Fang;WANG Jing-wen;CHANG Ying;WANG Lei;QIAO Yi;WEN Ai-dong
    . 2013, 15(6): 350-2.
    A 58-year-old female patient with type 2 diabetes mellitus treated with metformin hydrochloride (0.5 g twice daily)and insulin (subcutaneous of injection insulin 8、8、10 U before three meals respectively and subcutaneous injection of insulin glargine 8 U before sleep). Sitagliptin 100 mg once daily was added to her regimen due to unsatisfactory efficacy. Three weeks later, the patients felt nausea, vomiting and abdominal pain. Laboratory examination showed a serum amylase value of 267 U/L and urine amylase value of 933 U/L. Abdominal ultrasonography revealed seroperitoneum. She was diagnosed as having acute pancreatitis. Sitagliptin and metformin hydrochloride were withdrawn and insulin was continued. Symptomatic treatment such as acid suppression, inhibition of digestive enzyme and fluid supplement were given. Six days later, the patient′s condition improved, the levels of serum amylase and urine amylase were 76 U/L and 288 U/L, respectively.
  • 论著
    SU Ying-ying;TIAN Fei;CHEN Wei-bi;GAO Ran;ZHANG Yun-zhou;ZHANG Yan;YE Hong;GAO Dai-quan;LIU Fang
    . 2013, 15(1): 27-6.

    ObjectiveTo investigate the safety of a loading dose of IV antiepileptic drugs (AED) in the treatment of adult patients with generalized convulsive status epilepticus (GCSE).MethodsA method for the analysis of pooled data was adopted. The results from the two prospective randomized controlled trials (RCTs) performed by Xuanwu Hospital from January 2007 to January 2010 and from June 2010 to May 2012 were collected. The clinical data were analyzed and compared among the patients in the diazepam group,the diazepam and subsequent valproate group,and the diazepam and subsequent phenobarbital group. A loading dose of IV diazepam (0.2 mg/kg, 5 mg/min) was as first-line AED treatment for all patients in the 3 groups. Second-line AED treatment were as follows: in the diazepam group, a loading dose of IV diazepam (0.2 mg/kg, 5mg/min) was given, then a maintenance dose of IV diazepam (4.0 mg/h, increase by 1.0 μg/kg every 3 minutes) was given via a pump. In the diazepam subsequent valproate group,a loading dose of IV diazepam [30 mg/kg , 6 mg/(kg·min)] was given, then a maintenance dose of IV valproate 1-2 mg/(kg·h)was given via a pump. In the diazepam subsequent phenobarbital group, a loading dose of IV phenobarbital (20 mg/kg,50 mg/min)was given, then a maintenance dose of IV phenobarbital (100 mg/6 h, 50 mg/min) was given. The second-line AED treatment should be continued until 24 hours after epileptic seizure stopped, then the dosage was gradually reduced. The patients should be closely monitored for reactions after drug administration.ResultsA total of 101 patients were enrolled in the study. They comprised 53 male and 48 female with mean age of (42±16) years. The diazepam group comprised 20 male and 18 female with mean age of (41±19)years. The diazepam and subsequent valproate group comprised 22 male and 18 female with mean age of (45±15)years. The diazepam and subsequent phenobarbital group comprised 11 male and 12 female with mean age of (41±14)years. There was no statistically significant difference among the baseline data of patients in the three groups. The termination rate of GCSE in the diazepam,diazepam and subsequent valproate, and diazepam and subsequent phenobarbital groups were 63.2% (24/38), 57.5% (23/40)and 60.9% (14/23), respectively. The difference was not statistically significant (P=0.902). There were 6 cases(158%) of adverse reactions in the diazepam group. The number of cases of respiratory depression, circulatory depression,and bone marrow depression were 2, 3, and 1, respectively. There were 11 cases (27.5%) of adverse reactions in the diazepam and subsequent valproate group. The number of cases of slight hyperammonemia without hyperammonemia encephalopathy, mild abnormal liver function, and bone marrow depression were 8, 2, and 1, respectively. There were 11 cases (47.8%) of adverse reactions in the diazepam and subsequent phenobarbital group. The number of cases of respiratory depression, circulation depression, mild abnormal liver function, and bone marrow depression were 3, 2, 5, and 1, respectively. The incidence of adverse reactions in the diazepam group was markedly lower than that in the diazepam and subsequent phenobarbital group (P=0.033). The above-mentioned adverse symptoms could resolve after drug withdrawal and symptomatic treatment.ConclusionsA loading dose of IV diazepam or IV valproate or IV phenobarbital are effective and safe in the treatment of adult patients with GCSE. The patient should be closely monitored for adverse reactions during the antiepileptic treatment, especially in the patients receiving diazepam combined with phenobarbital. Once adverse reactions developed, the drug should be stopped and symptomatic treatment should be given.

  • 病例报告
    . 2007, 9(2): 138-139.
  • 调查研究
    Sun Lin;Liu Xiangyuan;Zhao Jinxia;Deng Xiaoli
    . 2009, 11(6): 397-9.
    Objective: To assess the risk of serious infections associated with tumor necrosis factorα(TNFα) inhibitors (etanercept, infliximab, and adalimumab) for treating patients with rheumatoid arthritis (RA). Methods:Searching PubMed, EMBASE, and Cochrane Library from January 1998 to January 2009, the published literature of randomized controlled trials on serious infections related to TNFα inhibitor use for treating patients with rheumatoid arthritis was collected. According to the criteria for entering, the literature was strictly selected and the quality of selected literature was assessed based on the demand of metaanalysis. And its results were analyzed by Review Manager 4.2 software. The odds ratio (OR), 95% confidence interval (95%CI), and P value for serious infections were calculated to assess the effect of TNFα on the risks of developing serious infections in patients with RA. Results: Sixteen randomized controlled trials were selected for metaanalysis. The 16 trials included 4 articles on etanercept, 5 on infliximab, and 7 on adalimumab. A total of 8541 patients entered the trials. Of them, 5 812 patients were in the TNFα group (1 347 patients receiving etanercept, 2 064 patients receiving infliximab, and 2 401 parents receiving adalimumab), and 2 729 patients in the control group. Metaanalysis revealed the following results: the pooled OR (95% CI) to serious infections was 1.43 (95% CI 1.08~1.89, P<0.05) in the TNFα inhibitor group, compared with the control group. In the etanercept, infliximab, and adalimumab groups, the OR (95% CI) was 0.93 (95% CI 0.59~1.45, P>0.05), 1.68 (95% CI 1.05~2.68, P<0.05), and 2.07 (95% CI 1.15~3.37, P<0.05), respectively. The risk of developing serious infections in the highdose TNFα inhibitor group was higher than that in the lowdose TNFα inhibitor group (OR 1.62, 95% CI 1.13~2.33, P<0.01) and the control group (OR 1.87, 95% CI 1.30~2.69, P<0.01). The differences were statistically significant. In a comparison of the lowdose TNFα inhibitor group to the control group (OR 1.31, 95% CI 0.93~1.85, P>0.05), there was no statistically significant deference in the risk of developing serious infections. Conclusion:The patients with rheumatoid arthritis receiving TNFα inhibitors could increase a degree of the risk of developing serious infections, especially in higher dosage. Therefore, the patients should be closely monitored following treatment with TNFα inhibitors in clinical practice.
  • 病例报告
    Hu Weidong①;Wang Shuya②
    . 2007, 9(6): 436-437.
    Two elderly patients developed hyperglycemia after intravenous infusion of gatifloxacin.The first patient,an 81-year-old man with acute exacerbation of chronic obstructive pulmonary diseases received intraveous infusion of gatifloxacin 0.4 g mixed with 250 ml of glucose injection 5% once daily.Three days later,he presented with dysphoria,polyuria,polydipsia,and fatigue.His blood glucose rose from 6.01 mmol/L to 28.84 mmol/L.Gatifloxacin was stopped.He was treated with IV insulin 12 U.Two days later,his blood glucose declined to 5.2 mmol/L.The second patient,a 61-year-old man with obstructive cholangitis and cholestatic cirrhosis received intravenous infusion of gatifloxacin 0.4 g mixed with 250 ml of glucose injection 5% once daily,glutathione 1.2 g mixed with 250 ml of glucose and sodium chloride injection once daily,and Xiaoyanlidan tablets 6 tablets thrice daily.On day 4 after treatment,his blood glucose increased from 5.60 mmol/L to 13.81 mmol/L.Then clindamycin was given instead o…更多f gatifloxacin.Three days later,his blood glucose dropped to 5.84 mmol/L
  • Li Dandan, Li Hongwei, Shen Su
    . 2016, 18(4): 282.
    Ticagrelor, a P2Y12 receptor reversible antagonist, plays the role of anti-platelet through inhibiting platelet aggregation medicated by adenosine diphosphate.Dyspnea is the most common adverse reaction of ticagrelor, and the possible mechanisms include adenosine accumulation theory: ticagrelor can lead to dyspnea by inhibiting the reuptake of adenosine through red blood cells, inducing ATP release from red blood cells, and then accumulate and degradate to adenosine or directly metabolize into adenosine analogs. Inhibition of neuronal P2Y12 receptor: ticagrelor can inhibit P2Y12 receptor, increase cAMP production, improve prostaglandin E2 (PGE2) activity, increase vagal C fibers excitability, and then cause dyspnea. Similar reaction to transfusion-related acute lung injury (TRALI): the reversible combination of ticagrelor and P2Y12 receptor could accumulate aged, exhausted, and destroyed platelets, initiate apoptotic program, lead to the similar reaction of TRALI, and finally cause dyspnea. Reducing the dose of ticagrelor or intravenous injection of theophylline (5 mg/kg) can effectively alleviate ticagrelor-related dyspnea.
  • Li Xue, Zhang Ping, Qi Haimei
    . 2017, 19(3): 215.
    A 59-year-old male patient received intravenous infusion of zoledronic acid 4 mg once a month because of esophageal cancer with bone metastasis. After 11 times of treatments, the patient developed parulis. Zoledronic acid was stopped. Then he was improved after abscess incision, irrigation drainage, and anti-infective treatments. Then an intravenous infusion of pamidronate 80 mg once a month was given. A total of 8 times of treatments were given and about 1 month after the last treatment, he developed pus and pain in local wounds, intermittent fever, and visible bone exposure and fistula formation after tooth extraction operation. Pamidronate was stopped, infected focal lesion of maxilla was cleared, his bone carinal was repaired, and systemic and local anti-infection treatments were given. Four months later, his wound was healed. Bisphosphonates associated osteonecrosis of maxilla was considered.
  • Xu Man, Xie Cheng
    . 2017, 19(4): 308.
    A 77-year-old male patient with hyperuricemia received febuxostat 40 mg orally once daily. On the night of the first dose administration, red rash appeared on his hands. On day 8, the skin rashes progressively spread over his entire body. The patient received an IV infusion of ticarcillin disodium/clavulanate potassium 3.2 g due to his pulmonary infection on the night of the same day. The next morning his symptoms of rashes worsened and accompanied with pruritus. Febuxostat and ticarcillin disodium/clavulanate potassium were withdrawn. He was given a temporary intravenous injection of dexamethasone 2 mg. On day 4 of drug withdrawal, his whole body turned red, dry and accompanied with severe pain and pruritus. He received an IV infusion of dexamethasone 10 mg once daily. On day 6, his skin had exfoliation (100% of body surface area). On day 11,he was diagnosed with exfoliative dermatitis and received an IV infusion of methylprednisolone 40 mg once daily and human immune globulin 20 g once daily. On day 16, his systemic skin became dry with desquamation. On day 19, his erythra almost disappeared.
  • Zhang Haihong, Mu Yan
    Adverse Drug Reactions Journal. 2020, 22(12): 717-718. https://doi.org/10.3760/cma.j.cn114015-20200325-00343
    A 78-year-old male patient with coronary atherosclerotic heart disease received intravenous infusions of levofloxacin lactate and sodium chloride injection 0.6 g once daily and cefminox sodium for injection 2 g once per 12-hours for pulmonary infection after percutaneous coronary intervention. Eight hours after the first medication, round reddish brown rashes, which were higher than the skin surface, appeared on the patient′s neck and limbs skin. The patient had a history of drug eruption after taking ciprofloxacin. After consultation with dermatologists, the patient was diagnosed as having fixed drug eruption, which was considered to be related to levofloxacin lactate and sodium chloride injection. Then the drug was discontinued and cefminox sodium was continued. At the same time, antiallergic treatment was given. Seven days later, the patient′s rash was subsided.
  • Zhang Weiwei, Du Wenwen, Li Pengmei
    Adverse Drug Reactions Journal. 2020, 22(12): 670-676. https://doi.org/10.3760/cma.j.cn114015-20200716-00781
    Objective To explore the clinical characteristics of pancytopenia induced by metho- trexate (MTX) in treatment for patients with ectopic pregnancy. Methods The diagnosis and treatment of a case of pancytopenia induced by MTX in treatment for a patient with ectopic pregnancy in China-Japan Friendship Hospital were reported. The main clinical features of this case and the related cases collected from CNKI, Wanfang, VIP, and PubMed databases (as of June 30, 2020) were summarized and analyzed. The total dose of MTX, time from the first dose of MTX to onset of pancytopenia, and lowest values of white blood cell count (WBC), hemoglobin (Hb), and platelet count (PLT) between the dead and the surviving patients were compared. Results A total of 18 patients were included in the analysis, aged from 20 to 41 years with an average age of 30 years. Among them, 2 patients were suffering from chronic kidney disease and undergoing renal dialysis. The time from the first dose of MTX to onset of pancytopenia in patients was (7±3) days, ranging from 3 to 19 days. The lowest values of WBC, Hb, and PLT were (0.80±0.55)×109/L, (70±22) g/L, and (30±27)×109/L, respectively. Red blood cell count values were descripted in 10 patients and the lowest value was 1.98×1012/L. The severity of pancytopenia were defined as grade 2, grade 3, grade 4, and grade 5 in 5 patients (27.8%), 6 patients (33.3%), 1 patient (5.6%), and 6 patients (33.3%), respectively. The main clinical manifestations were skin and mucous membrane damage (in 18 patients), fever (in 17 patients), and gastrointestinal reaction (in 13 patients). Eleven patients (61.1%) had complications and 6 of them died. The median value of the lowest WBC in the dead patients was significantly lower than that in the surviving patients [0.35 (0.20-0.60)×109/L vs. 0.83 (0.22-1.80) ×109/L, Z=2.722, P=0.007], whereas the differences in the total dose of MTX, time to onset of pancytopenia, or lowest values of Hb and PLT between the dead and the surviving patients were not statistically significant (all P>0.05).Conclusion Pancytopenia is a rare but fatal adverse reaction of MTX in treatment for patients with ectopic pregnancy and patients with lower WBC often have a worse prognosis.
  • 论坛
    . 2014, 16(5): 257-2.
  • Liao Wanmin, Ai Ling, Zhang Xianwei
    . 2015, 17(5): 391.
    A 49 year-old female underwent laparoscopic uterine myoma plus hysteroscopy operation under general anesthesia. She received an intravenous injection of dezocine 2.5 mg because of pain after anesthesia recovery. About 20 seconds later she fell asleep. She developed orbit-pressing reflex slowing, cyanosis of lips, and reduced amplitude of respiration. Her pulse oxygen saturation was 0.80, breathing rate was 7 beats/min. The patient received nasal catheter oxygen immediately. Her pulse oxygen saturation returned to 1.00, breathing rate increased to 16/min one minute later, and regained consciousness gradually.
  • 病例报告
    Liu Na;Hu Jiangwei;Hou Caiyan;Shu Xiangrong;Wu Ye;Li Jin
    . 2007, 9(3): 205-205.
    A 39-year-old woman with chronic granulocytic leukemia was administered with imatinib mesylate 400 mg twice daily. Two days later, she developed dyspnea, hypotension, and Kussmaul's sign. A chest CT scan showed hydropericardium and pleural effusion. After discontinuation of the drug and performance of thoracentesis as well as pericardiocentesis, she recovered.
  • 调查研究
    Wang Xiuyun;Fang Juanjuan
    . 1999, 1(3): 151-154.
    Objective: To find out the situation of drug-use in our hospital and show the importance of pharmaceutical care in hospitals. Methods: 218 medical records of the patients discharged from hospital in Apr. 1999 were sampled randomly, and 1301 prescriptions were analysed. The frequency of the same drug used, drugs used in combination and the drug interaction were calculated. Results: The prescriptions, each for use of drugs above six kinds, accounted for 75.4% . The prescriptions causing the rise of adverse drug interactions accounted for 12.7% . Conclusion: As drugs used in combination were so many, pharmaceutical care should be strengthened to assure the use in effective, safe and economic way.
  • 病例报告
    Zhong Jianling;Chen Shizhu;Xie Bo
    . 2011, 13(4): 253-2.

    Four male patients (aged 20,40,22, and 28 years) with chronic superficial gastritis or duodenal ulcer or gastric ulcer received omeprazole 20 mg twice daily. Three of them were given oral omeprazole alone. One of them received combined treatment with omeprazole, azithromycin, and colloidal bismmth pectin. Two days later, they developed dizziness, fatigue, chest distress, and short of breath. Their heart rate decreased to 44 beats/min, 46 beats /min, 46 beats /min, and 44 beats /min, respectively. After discontinuation of omeprazole and administration of IM atropine 0.5 mg 3 times a day, four patients’ heart rate returned to baseline.

  • 病例报告
    . 2000, 2(2): 119-119.
  • 病例报告
    Zhan Shengli;Cai Ming;Shi Bingyi;Li Zhouli;Wei Xing;Liang Tao;Li Pengcheng
    . 2009, 11(3): 218-3.

    Two man with coronary artery disease or myocardial ischemia developed priapism after receiving alginic sodium diester (dosage not stated).Patient 1, a 35-year-old man with coronary artery disease, received an IV infusion of alginic sodium diester. On day 7, the patient developed priapism, and then he was hospitalized with an erection of 32 hours duration. The man underwent blood aspiration from the corpora cavernosa and received corpora cavernosa irrigation with phenylephrine, low molecular weight heparin, and normal saline. Three days later, his priapism resolved.Patient 2, a 41-year-old man with myocardial ischemia, received an IV infusion of alginic sodium diester. On day 3, the patient developed priapism, and then he was hospitalised with an erection of 72 hours duration. Corpora cavernosa irrigation and cavernosal-glandular shunt were not successful in relieving the priapism. Subsequently, cavernosalglandular shunt plus cavernous dilation were performed again. The next day, his priapism subsided completely.

  • 安全用药
    . 2003, 5(3): 176-177.
    吉西他滨是一种破坏细胞复制的二氟核苷类抗代谢药物,主要用于治疗局部进展性或转移性非小细胞肺癌和不能手术的晚期或转移性胰腺癌。吉西他滨的常见不良反应有骨髓抑制、胃肠道反应、流感样反应、水肿、过敏反应、肾毒性等。本文对其不良反应及防治予以介绍。
  • Li Ning, Chen Huanlei, Wang Zhenhua
    Adverse Drug Reactions Journal. 2023, 25(5): 271-275. https://doi.org/10.3760/cma.j.cn114015-20221008-00896
    Objective To explore the adverse reaction risk signals of Xuesaitong injection, and provide reference for the safe and reasonable application of the drug.-Methods The risk signals of adverse reactions/events (AR/AE) associated with Xuesaitong injection were mined using 3 methods, including reporting odds ratio (ROR), proportional reporting ratio (PRR), and the Comprehensive Standard-Method of Medicines and Healthcare Products Regulatory Agency (MHRA) based on data in Shandong Province Adverse Drug Reaction Monitoring Center Database from 2018 to 2020. Results A total of 2-606 AR/AE reports with Xuesaitong injection as the primary suspect drug were collected, involving 1-209 males (46.39%) and 1-397 females (53.61%). The median age of these patients was 63 years, ranging from 10 to 100 years, and 55.72% (1-452/2-606) of them were over 60 years. Severe AR/AE accounted for 13.24% (345/2-606). AR/AE involved a total of 15 organs/systems, and relevant preferred names (PN) appeared 4-218 times. Among them, the organs/systems involved ranking top 3 in frequency were skin and accessories [37.15% (1-567/4-218)], systemic disorders [18.21% (768/4-218)], and central and peripheral nervous system [14.13% (596/4-218)]. There were a total of 19 risk signals that were positive by the ROR, PRR, and MHRA method, including sneezing, worsening palmus, discomfort in the cardiac area, dry throat, worsening headache, distention in the head, shortness of breath, convulsions, chills, high fever, chest tightness, tachycardia, worsening dizziness, papules, skin warm, palpitation, palmus, feeling cold, and erythema. The top 5 PN with severe cases were shortness of breath, high fever, convulsions, tachycardia, and chest tightness. Conclusions Xuesaitong injection can lead to severe anaphylaxis and the most common organs/systems involved are skin and accessories, systemic disorders, and central and peripheral nervous system. Severe cases often present with shortness of breath, high fever, convulsions, tachycardia, and chest tightness, which require intensive monitoring during use of the drug.
  • Cheng Xiuli, Jiang Qingjun, Hu Jin
    Adverse Drug Reactions Journal. 2022, 24(10): 551-553. https://doi.org/10.3760/cma.j.cn114015-20220211-00113
    A 54-year-old female patient with aortic dissection received parenteral nutrition treatments due to malnutrition risk, including IV infusions of fat emulsion amino acid (17) and glucose (11%) injection 1 440-ml once daily, compound amino acid injection (18 AA-II) 250-ml once daily, and medium and long chain fat emulsion injection (C6-24) 250-ml once daily. Other treatments included drugs to maintain blood pressure and control heart rate, analgesics, 10% potassium chloride injection, etc. The laboratory tests before treatments showed alanine aminotransferase (ALT) 36-U/L, aspartate aminotransferase (AST) 35 U/L, γ-glutamyl transpeptidase (γ-GT) 51-U/L, total bilirubin (TBil) 8.3-μmol/L, and alkaline phosphatase (ALP) 129 U/L. After 8 days of parenteral nutrition treatments, laboratory tests showed ALT 343-U/L, AST 357 U/L, γ-GT 343-U/L, TBil 21.4-μmol/L, and ALP 376-U/L. The liver injury caused by parenteral nutrition was considered. Parenteral nutrition was stopped, other treatments were continued, and liver-protective treatments such as glutathione combined with diethylamine dichloroacetate were given. Eight days later, the laboratory test showed ALT 42-U/L, AST 29-U/L, γ-GT 55-U/L, TBil 8.4-μmol/L, and ALP 107-U/L.
  • 调查研究
    Yang Liancheng;Zhou Zhuan;Chen Tongli;Yang Xinying
    . 2000, 2(4): 228-232.
    Objective: To understand the aspects of drug-induced allergic shock and its causes. Methods: The cases with drug-induced allergic shock were retrieved from 24 journals in Chinese of 1991-1999. Results: 487 cases were collected and the allergic shock was caused by 109 drugs, mostly by antibiotics. It came rapidly with 69 deaths, occuring within 5 minutes after drug administration in 65% of the patients (317 cases) . The reasons of the shock were discussed in this paper. Conclusion: The work here is for clinical reference in order to reduce its occurrence and the resulting death.
  • 调查研究
    Zhang Enjuan;Ge Qin;Jiang Min
    . 2004, 6(1): 17-19.
    Objective: To investigate the occurrence of anaphylactic shock induced by lincomycin injection. Method: The reports of lincomycin-induced shock were re trieved and analysed, totaling 44 papers on 46 domestic medical journals of 199 4-2002. Results: Anaphylactic shock occurred in 61 cases, including 8 deaths. Co nclusion: Anaphylactic shock due to lincomycin should be paid more attention to , being dangerous enough to cause death if treated improperly and untimely.
  • Wang Hujun;Zhai Jianguo
    Adverse Drug Reactions Journal. 2010, 12(1): 53-2.
    Three male patients, aged 46~91 years, received respectively an IV infusion of linezolid 600 mg twice daily for infections. Their platelet counts were normal before linezolid administration. All of them developed thrombocytopenia after 3~17 days of therapy. Platelet counts were 95×109/L, 74×109/L, and 86×109/L, respectively. Linezolid was stopped and switched to imipenemcilastatin sodium, vancomycin, and meropenem; and other treatments were unchanged. The level of platelet returned to within normal range.
  • 病例报告
    Li Lina;Bie Junb
    . 2008, 10(5): 0-0.

    A 60-year-old man with small cell lung cancer was treated with a chemotherapy regimen consisting of IV cisplatin 30 mg on days 1~3 and IV irinotecan 240 mg on day 3 in 28-day cycles. He took sodium bicarbonate 0.5 g thrice daily while starting chemotherapy. On day 5 of chemotherapy, the patient experienced diarrhea with 10 watery stools and more a day. The volume of watery stool was 40~50 ml each time. He presented with mild dehydration. Loperamide, norfloxacin,and fluid replacement were given immediately. His diarrhea was relieved.

  • 学术讨论
    . 2001, 3(1): 38-40.
    药物安全性的可靠资料大多来自临床试验报告。由于各种原因,对同一种药物的安全性试验,报告的结果之间存在着一定的差异,因而单项临床试验的结果不足以作为评价用药风险的科学证据。传统的综述方法对众多单项试验结果的合并能力有限,因而系统性综述方法开始被运用到药物安全性评价领域。本文介绍了系统性综述法和定量综述法—荟萃分析(Meta-analysis)的基本概念,详细介绍了实施步骤,对该方法的推广和正确使用有参考价值。
  • Xun Pinga;Sun Lib;Li Zhongyana;Yu Donghuia
    Adverse Drug Reactions Journal. 2010, 12(1): 68-2.
    A 50yearold man was hospitalized for angina pectoris. He received an IV infusion of sodium ferulate 0.3 g dissolved in 0.9% sodium chloride 150 ml and an IV infusion of cinepazide maleate 160 mg in 250 ml of glucose 5%. Meanwhile he was given aspirin, atorvastatin, benazepril, and isosorbide mononitrate. On admission, the patient developed diarrhea with 10 watery stools per day after infusion completion. On second day, his symptoms aggravated after readministration of an intravenous infusion. His diarrhea was considered possibly related to cinepazide maleate, and then cinepazide maleate was withdrawn and other medications were continued, his diarrhea stopped.
  • Tian Ye, Zhang Muyu, Han Sheng, Guan Xiaodong, Zou Wujie, Shang Jinxin, Shi Luwen
    . 2017, 19(5): 340.
    ObjectiveTo explore the possible safety difference of anti-infective agents with the same generic drug name produced by different manufacturers.MethodsSpontaneous Reporting System for Adverse Drug Reactions of Beijing was searched. The reports of adverse drug reactions (ADR) of levofloxacin, azithromycin, moxifloxacin, clindamycin, cefuroxime, etimicin, cefoperazone sulbactam sodium, cefoxitin, ceftriaxone and ornidazole from January 2009 to December 2013 were collected. The number of ADR reports, types of ADR, suspicious drugs which induced ADR, and the manufacturers were recorded. The number of ADR signals was detected by reporting odds ratio (ROR) method. The safety of drugs was evaluated according to the number of signal and the type of ADR.ResultsA total of 18 366  ADR reports of 10 kinds of anti-infective drugs were collected. The top five ADR′s types were skin and subcutaneous tissue diseases (7 644), gastrointestinal diseases (2 505), systemic diseases and various parts of the site of treatment (1 761), nervous system disease (1 592) and immune system diseases (1 254) successively. The sum of the digits above accounted for 80.3% in total number of 10 kinds of anti-infective drugs ADR reports (14 756/18 366). The drugs which caused the five kinds of ADR were levofloxacin, azithromycin and clindamycin/moxifloxacin mainly. The numbers of ADR signals of evofloxacin, azithromycin, moxifloxacin, clindamycin, cefuroxime, etimicin, cefoperazone sulbactam sodium, cefoxitin, ceftriaxone, and ornidazole which were detected by ROR method were 17, 20, 1, 23, 9, 9, 20, 5, 1 and 9, respectively. The ADR types related to ADR signals were 11, 12, 1, 12, 6, 8, 10, 5 and 8, respectively. The numbers of manufacturers related to ADR signals were 9, 13, 1, 14, 6, 9, 11, 5, 1 and 9, respectively.ConclusionsThere are some differences in ADR signals and ADR types among the 10 kinds of anti-infective agents with the same generic drug name produced by different manufacturers. It is suggested that there are some differences in safety of the above-mentioned drugs.
  • Lai Yuan, Zhang Jin, Li Kai
    Adverse Drug Reactions Journal. 2020, 22(5): 283-288. https://doi.org/10.3760/cma.j.cn114015-20200223-00151
    Objective To explore the effect and safety of dexmedetomidine with different ways of administration on nerve block anesthesia in elderly patients undergoing untensioned repair of inguinal hernia. Methods The elderly patients who underwent untensioned repair of inguinal hernia in Shenyang Fourth People′s Hospital from June 2017 to June 2019 and met the inclusion criteria were randomly divided into local nerve block by ropivacaine+dexmedetomidine group (local anesthesia group) and local nerve block by ropivacaine+intravenous pumping of dexmedetomidine group (local anesthesia+intravenous pumping group) using random number table. Local anesthesia group: 15-ml of solution obtained by a certain dose of dexmedetomidine (calculated by 1-μg/kg) diluted in a suitable volume of 0.9% sodium chloride injection+15-ml of 0.375% ropivacaine were injected locally among iliohypogastric nerve and ilioinguinal nerve under the guidance of ultrasound, and meanwhile 0.9% sodium chloride injection were pumped intravenously at the speed of 1-ml/(kg·h) until the end of operation. Local anesthesia+intravenous pumping group: a dose of dexmedetomidine (calculated by 1-μg/kg) was intravenous pumped, 30-ml of 0.375% ropivacaine were injected among iliohypogastric nerve and ilioinguinal nerve under the guidance of ultrasound 10-minutes later, and at the same time, dexmedetomidine was pumped intravenously at the speed of 0.25-μg/(kg·h) until the end of operation. The patients′ basic information including sex, age, body weight, body height, grade determined by American Society of Anesthesiologists Physical Status Classification, and the operation time were recorded. The changes of heart rate and mean arterial blood pressure (MAP) at different time points [before anesthesia (T0), anesthesia completion (T1), beginning of operation (T2), 15-minutes after anesthesia (T3), 30-minutes after anesthesia (T4)], the onset and maintenance time of sensory nerve block, the analgesic effect during the operation, the patient analgesia satisfaction score at the 24th hour after operation, the visual analogue scale (VAS) scores at 0, 3rd, 6th, 9th, and 12th hour after operation in resting state, and the occurrence of adverse reactions were compared between the 2 groups. Results The differences of basic information in patients between the 2 groups were not statistically significant (P>0.05 for all). The heart rate of patients at T2 and T3 in the local anesthesia+intravenous pumping group were lower than those in the local anesthesia group [(62.55±5.66) beats/min vs. (76.70±6.47) beats/min, (53.83±5.07) beats/min vs. (74.98±5.40) beats/min, P<0.001 for both]. Intra-group comparison showed that the heart rate of patients at T2 and T3 were lower than that at T0 in the local anesthesia+intravenous pumping group [(62.55±5.66) beats/min vs. (72.50±7.14) beats/min, (53.83±5.07) beats/min vs. (72.50±7.14) beats/min, P<0.001 for both]. The differences of MAP at different time points between the 2 groups and in intra-group comparison were not statistically significant (P>0.05 for all). The onset time of anesthesia in the local anesthesia group was shorter than that in the local anesthesia+ intravenous pumping group [(5.2±1.1) min vs. (12.5±0.7) min, P=0.010], while the maintenance time of anesthesia was longer [(742.5±3.5) min vs. (631.0±1.4) min, P=0.010]. There were 38(95%), 2(5%), and 0(0) patients having good, fine, and bad analgesic effect in the local anesthesia group, and 30(75%), 8(20%), and 2(5%) in the local anesthesia+intravenous pumping group, respectively. The difference of analgesic effect between the 2 groups was statistically significant (χ2=6.541, P=0.038). The patients′ anesthesia satisfaction score at the 24th hour after operation in the local anesthesia group was higher than that in the local anesthesia+intravenous pumping group [(9.5±0.7) vs. (7.0±1.4), P=0.030]. The VAS scores at 0, 3rd, 6th, 9th, and 12th hour after operation in resting state in the local anesthesia+intravenous pumping group were higher than those in the local anesthesia group (P<0.05 for all). Intra-group comparison showed that the VAS scores at the 5 time points above-metioned in the local anesthesia group were no statistically significant (P>0.05 for all), the VAS scores at 9th and 12th hour after operation in the local anesthesia+intravenous pumping group were higher than that at 3rd hour, the differences were statistically significant (P<0.05 for both). The dif- ference of the incidence of adverse reactions after operation between the 2 groups was not statistically significant (χ 2=0.697, P=0.410). Conclusions The analgesic effect of local injection of ropivacaine+dexmedetomidine is better than that of local nerve block of ropivacaine+intravenous pumping of dexmedetomidine. Thus the anesthesia program of local nerve block with ropivacaine+dexmedetomidine is recommended in the elderly patients undergoing untensioned repair of inguinal hernia.
  • Chen Yanzeng, Wang Xiaochun, Lei Zhaobao, Yang Caixia
    . 2018, 20(1): 56.
    A 52-year-old male patient received an IV infusion of cefuroxime sodium 1.5 g one hour before undergoing vasovasotomy (skin test: negative). One hour after the operation, he received IV infusion of levofloxacin hydrochloride sodium chloride injection 0.4  g and cefuroxime sodium 1.5 g. The sporadic light red erythra appeared on his both lower extremities and skin redness on his  feet achilles tendon on the next day. The clinical doctor thought that the erythra was not serious, so the drugs were not stopped. On day 3 after operation, his erythra was serious. There were blisters on the erythra, accompanied with pruritus and mild pain. The serious skin redness eveloped on his achilles tendon of both feet and accompanied by mild pain. The patient was diagnosed as erythema morbilliforme and tendinitis achillea which might be related to levofloxacin hydrochloride and cefuroxime sodium. Levofloxacin hydrochloride sodium chloride injection and cefuroxime sodium were stopped. The patient received symptomatic treatment including antianaphylaxis. On day 3 of drug withdrawal, the erythema decreased, the blisters were absorbed. The degree of inflammation alleviated. On day 6 of drug withdrawal, his erythema and tendinitis achillea recovered.
  • Shi Yingqin, Li Yao
    . 2018, 20(1): 62.
    A 78-year-old female patient with acute cerebral infarction received butylphtha-lide soft capsules 0.2 mg thrice daily. One week later, she experienced fatigue and anorexia. Two weeks later, she presented with yellowish skin and sclera. Laboratory tests revealed the following levels: aminotransferase (ALT) 1 574 U/L, aspartate aminotransferase (AST) 1 135 U/L, direct bilirubin (DBil) 58.8 μmol/L, indirect bilirubin (IBil) 62.0 μmol/L. Liver damage was diagnosed and considered to be related to butylphthalide soft capsules, and then the medication was discontinued. The patient was given IV infusions of reduced glutathione 1.8 mg, Shuganning injection (舒肝宁注射液)10 ml, polyene phosphorylcholine 232.5 mg and magnesium isoglycyrrhizinate 150 mg once daily. On day 4 after symptomatic treatment, she had an ALT level of 840 U/L, an AST level of 640 U/L, a DBil level of 50.1 μmol/L, an IBil level of 57.1 μmol/L. On day 17, the yellowish skin and sclera significantly improved, the diet returned to normal and physical strength recovered, the results of reexaminination showed ALT 64 U/L, AST 41 U/L, DBil 13.9 μmol/L, IBil 18.6 μmol/L.
  • Qiu Yanlong, Ma Ling, Xiang Longyun, et al
    Adverse Drug Reactions Journal. 2019, 21(6): 406-413. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.002
    ObjectiveTo understand preliminarily the current status of medication safety management in medical institutions in Linyi.MethodsSelf assessments of medication safety on the principle of voluntariness were conducted in the member units of the Clinical Pharmacy Committee of Linyi Medical Association (all were public hospitals), which were organized by the Linyi Pharmaceutical Affairs Quality Control Center. The investigation was conducted in using the questionnaires of "2011 ISMP Medication Safety Self Assessment for Hospitals (Chinese version)". The questionnaire included 10 key elements, 20 core indicators, and 270 assessment projects. Twenty-nine of the 67 member units expressed willingness to participate. A WeChat version of the questionnaire was sent on February 28, 2018 and required to complete and submit within 3 months. After the questionnaire was collected, the overall implementation status of each key element and each assessment project in all participated hospitals were counted. The results were expressed in the proportion of implementation, partial implementation, and non-implementation, and the implementation status in urban hospitals and rural hospitals were descriptively analyzed.ResultsAs of May 28, 2018, the questionnaires in 24 of 29 hospitals were submitted and the recovery rate was 82.8%. Twenty-four hospitals were from one district and 7 counties (3 districts and 9 counties in total), including 12 urban hospitals (4 tertiary hospitals and 8 secondary hospitals) and 12 rural hospitals (all were primary hospitals). Among the 10 key elements, the elements Ⅶ (environmental factors, workflow and staffing patterns) had the highest proportion of overall implementation [56.55% (285/504)] in the 24 hospitals, and the elements Ⅱ (drug information) had the lowest one [26.77% (212/792)] . In the 24 hospitals, the implementation proportion of 270 assessment projects was 37.11% (2 405/6 480), the partial implementation proportion was 26.33% (1 706/6 480), and the non-implementation proportion was 36.56% (2 369/6 480). The key elements with the highest and lowest implementation proportions in the 12 urban hospitals were Ⅶ[62.70% (158/252)] and Ⅱ[33.08% (131/396)], respectively. The key elements with the highest and lowest implementation proportion in the 12 rural hospitals were Ⅶ [50.40% (127/252)] and Ⅳ [drug labeling, packaging, and nomenclature, 15.28% (33/216)], respectively. The proportions of implementation, partial implementation, and non-implementation of 270 assessment projects in the urban hospitals were 49.32% (1 598/3 240), 29.48% (955/3 240), and 21.20% (687/3 240), respectively, and 24.91% (807/3 240), 23.18% (751/3 240), and 51.91% (1 682/3 240) in the rural hospitals, respectively. The implementation proportion of key elements in the rural hospitals was lower than that in the urban hospitals.ConclusionsThe results of the questionnaire preliminarily reflected the current status of medication safety management in urban and rural hospitals in Linyi City. There are great differences in the implementation of key elements related to medication safety between the urban and the rural hospitals, but the levels of medication safety management in both rural and urban hospitals need to be improved.
  • Sheng Xiaoyana;Tang Ziyonga;Duan Jinglia
    Adverse Drug Reactions Journal. 2010, 12(1): 66-2.
    A 17yearold women with pulmonary tuberculosis received pyrazinamide, ethambutol, rifampicin, and isoniazid. Two months later, pyrazinamide and ethambutol were stopped and rifampicin 0.45 g/d and isoniazid 0.3 g/d were continued. After another three months, the patient developed pitting edema in both lower extremities, followed by asthenia, short of breath, and frothy urine. Rifampicin and isoniazid were stopped. Laboratory tests revealed the following levels and values: plasma Alb 12.6 g/L, TG 2.11 mmol/L, 24hour urine protein 5.511~8.283 g, CCr 181 ml/min. Oral prednisolone and symptomatic treatment were given. Meanwhile, she was treated with pyrazinamide, ethambutol, and isoniazid for consolidation of therapeutic effect. Fifteen days later, her symptoms improved and she was discharged. She had no recurrence at follow up.
  • 中毒救治
    Huang Renfa;Shi Wei;Wu Jinyu;Tang Yu;Xie Liping
    . 2007, 9(6): 412-413.
    A 73-year-old woman took about 20 g of kaemfer dutchmanpipe root powder for treating stomach discomfort.Ten minutes later,she developed vomiting.She did not resolve Despite symptomatic therapy.Three days later,she developed oliguria.A routine urine test revealed the following values:pH 9.0,Glu(+),PRO(┼┼),and KET(+).She had a BUN level of 17.8 mmol/L,a SCr level of 708 μmol/L,and a UA level of 294.5 μmol/L.A B-ultrasonography showed diffused parenchymatous lesions in the kidneys.She was diagnosed with acute aristolochic acid nephropathy and acute renal failure due to kaempfer dutchmanspipe root poisoning.After treatment with Jinshuibao capsules,dopamine,furosemide,sodium bicarbonate,hydrocortisone,and hemodialysis,the patient's urine volume gradually increased.Her renal function improved and the symptoms disappeared.At follow-up 3 months later,her renal function remained stable
  • 病例报告
    Jin Zhenbo
    . 2007, 9(4): 280-281.
    A 34-year-old woman with hyperthyroidism was given propylthiouracil 100 mg thrice daily and diazepam 10 mg thrice daily.Nineteen days later,she developed a fever(T 38.3 ℃),skin rash,pharyngodynia,nausea,and so on.Laboratory test revealed:WBC count 1.18×109/L,neutrophile granulocyte count 0.50×109/L,ALT level 457 U/L,AST level 120 U/L,blood glucose level 8.49 mmol/L.Propylthiouracil was withdrawn.The patient was treated with reduced glutathione,silybin meglumine,loratadine,diazepam,and filgrastim.After 4 weeks of therapy,the patient's blood routine returned to normal limits and her liver function obviously improved.
  • 病例报告
    Zhang Daoli;Li Fang
    . 2007, 9(3): 202-203.
    A 28-year-old man with recurrent ulcerative colitis received sulfasalazine 1g four times daily. One week later, he developed continual epigastric tormina with nausea and vomiting. His serum amylase level was 601 U/L, and urinary amylase level was 1703 U/L. He was hospitalized with acute pancreatitis. After the discontinuation of sulfasalazine and receiving symptomatic therapy, the patient recovered and was eventually discharged. At follow-up, 2 years and 7 months later, there was no recurrence of the acute pancreatitis.
  • 安全信息
    . 2011, 13(6): 400-2.
  • 病例报告
    GUO Heng;XIN Hua-wen;PANG Yu-tao;FAN Xing
    . 2012, 14(5): 324-3.
    A 26-year-old male patient, who had undergone renal transplantation 4 years before and received hemodialysis in the past 5 months, was treated with an IV infusion of piperacillin sodium and tazobactam sodium 4.5 g in 0.9% sodium chloride 100 ml once daily for pulmonary infections. Five hours after the second infusion, the patient suddenly experienced convulsion, unconsciousness, upward deviation of the eyes, and twitching of legs. He was given IM diazepam 10 mg, followed by IV diazepam 7 mg, and then above-mentioned symptoms subsided.
  • 药物评介
    . 2001, 3(2): 133-135.
  • 安全用药
    . 2002, 4(3): 159-161.
  • 病例报告
    Meng Yunhui
    . 2009, 11(5): 314-1.

    A 40-year-old man received ibuprofen 50 mg thrice daily for pain in his right lower limb. About 2 months later, the patient developed palpitations, nausea, vomiting, and decreased urinary output (300 ml/d), then presented to hospital. Routine urine testing revealed 2 + protein and renal function tests showed a BUN level of 51.7 mmol/L, a SCr level of 1490.4 μmol/L. Reducing blood pressure and blood purification treatments were given. One months later, his renal function gradually normalized. -

  • 论著
    Huang Xiong;Du Wenjia;Xue Shijian;Tong Zishun;Jiang Zeyu
    . 2008, 10(2): 77-4.

    Objective:To compare the efficacy in treating schizophrenia and the influence on serum prolactin level of aripiprazole versus risperidone. Methods: Eighty patients with schizophrenia in our hospital from May 2005 to May 2006 were randomly divided into following two groups: the aripiprazole group (40 cases) and the risperidone group(40 cases). The initial dose in the aripiprazole group was 10 mg/d, and subsequent dose was increased to 20~30 mg/d in the end of 2 weeks. The initial dose in the risperidone group was 1 mg/d, and subsequent dose was increased to 4~6 mg/d in the end of 2 weeks. The total duration of treatment was 8 weeks. The curative effects and adverse reactions in the two groups were evaluated with the positive and negative syndrome scale (PANSS) and the treatment emergent symptoms scale (TESS). Serum prolactin level was measured with chemoluminescence technique. Results:The effective rate in the aripiprozole and risperidone groups was 72.5% and 77.5%, respectively. There was no significant difference between the two groups (P>0.05). The principal adverse reactions in the aripiprazole group were drowsiness, headache, gastrointestinal disorders, and akathisia; lactation and amenia were not found. The main adverse reactions in the risperidone group were acute myodystonia, tremor, akathisia, lactation or amenia, and weight gain. Serum prolactin level after 8 weeks of risperidone treatment was higher than that before treatment. The difference was markedly significant (P<0.01). The serum prolactin level was elevated 3.5 times in male patients and 8 times in female patients. And the serum prolactin level was no changes in the aripiprazole group. Conclusion:Aripiprazole is a relatively effective and safe agent in the treatment of schizophrenia.

  • 病例报告
    . 2004, 6(5): 335-336.
  • 调查研究
    Gao Wenbin;Wang Lishuang;Wang Lei;Wang Huaijin;Yin Liangwei
    . 2003, 5(3): 156-159.
    Objective:To investigate the blood toxicity of topotecan and evaluate its safety in clinical practice.Method:113cases with non-small cell lung cancer were divided into three treatment groups:53cases in TP group(topotecan0.75mg per m 2 body-surface and cisplatin20mg per m 2 on days1to5),30cases in NP group(vinorelbine25mg per m 2 on day1and day8,and cisplatin20mg per m 2 on days1to5),30cases in HP group(hydroxycamptothecine6mg per m 2 and cisplatin20mg per m 2 on days1to5).3courses(a course of21days)were given,then the blood toxicity was assessed.Results:The efficacy rate of TP group was39.62%,NP group33.33%and HP group30.00%,with no significant differences between them(P>0.05).As for blood toxicity in TP group,third degree and fourth degree leucopenia occured in18and15cases respectively,accounting for62.26%,and third degree and four th degree thrombocytopenia in15and13cas-es respectively,accounting for52.83%.Compared with NP and HP groups,both leucopenia and thrombocytopenia in TP group showed significant differences(P<0.05).Conclusion:Blood counts should be made frequently because white blood cells and platelets would be seriously affected by topotecan,resulting in leucopenia and thrombocytopenia.
  • Cai Yinglian, Yang Wenhua, Zhang Min, Zheng Zhongjian, Lin Senlin, Lin Yiqing, Chen Shuifang, Chen Xuemei
    Adverse Drug Reactions Journal. 2024, 26(11): 658-664. https://doi.org/10.3760/cma.j.cn114015-20240607-00423
    Objective To explore the characteristics and mechanism of Chinese herbs with fertility toxicity. Methods Chinese herbs with reproductive toxicity, developmental toxicity and genetic toxicity were retrieved from Traditional Chinese Medicine System Toxicology Database. The property, taste, meridian tropism, toxicity classification and performance, and the toxic component and action target of each medicinal material were collected and descriptive statistical analysis was performed. Results A total of 55 kinds of Chinese herbs with fertility toxicity were screened out. They were mostly warm [20 (36.4%)] or cold [15 (27.3%)] in property, and mostly bitter and pungent in taste [bitter-pungent, bitter, and pungent accounted for 30.9% (17/55), 23.6% (13/55) and 18.2% (10/55)]. The channel tropisms were mainly liver, lung, spleen, and kidney [58.2% (32/55), 38.2% (21/55), 38.2% (21/55) and 34.5% (19/55)], and the main manifestations of its reproductive toxicity were reproductive function damage in males and females, abnormal embryonic growth and development and genetic/cytotoxicity, which might lead to reduced pregnancy rate, miscarriage, abnormal fetal growth and development, etc. There were 29 kinds of Chinese herbs with 35 known fertility toxic components. Among them, 30 toxic components had 11 known toxic targets. The more common toxic targets included thyroid hormone receptor beta, cytochrome P450 1A1, sex hormone-binding globulin and interleukin-1 beta. Conclusions Chinese herbs with fertility toxicity are mostly warm or cold in property, and bitter and pungent in taste; their channel tropisms are mainly liver, lung, spleen and kidney; they mainly affect fertility and embryonic development by changing the body′s endocrine and interfering with sex hormone metabolism.
  • Gan Jimei, Han Xiaojun, Huang Yao, Xu Guoqiang, Yang Qiao
    Adverse Drug Reactions Journal. 2023, 25(6): 376-378. https://doi.org/10.3760/cma.j.cn114015-20220525-00463
    A 31-year-old female patient accidentally found a bean-sized lump under the right buttock, causing slight pain when pressing. Ultrasound examination revealed multiple cystic nodules of varying sizes in the subcutaneous fat layer of the right buttock. The patient underwent right buttock mass resection and was diagnosed as foreign body granuloma according to the postoperative pathology and medical history. Five years ago, the patient received bilateral intramuscular injection of progesterone (10-15-mg once daily) into the buttocks for 3 months due to threatened miscarriage. Afterwards, no other medication was injected into the buttocks. Therefore, it was considered that the foreign body granuloma in her buttock was related to the injection of progesterone. Two months later, the patient underwent extended resection of soft tissue tumor under the gluteus maximus muscle of the left buttock, and the postoperative pathological results were the same as that of the first time.
  • 病例报告
    Jiang Fangning
    . 2008, 10(3): 213-2.

    A 33yearold woman was hospitalized with viral hepatitis B, hepatic cirrhosis (compensation period), splenomegaly, and portal hypertension. The woman developed marked swelling of bilateral parotid glands and submandibular glands with mild tenderness about 20 minutes after starting intravenous infusion of tiopronin 0.2 g. Tiopronin was discontinued immediately, and her salivary glands swelling subsided gradually. Later, tiopronin was switched to diammonium glycyrrhizinate, and salivary glands swelling did not reappear.

  • Wu Jinglin;Sun Yanbing
    Adverse Drug Reactions Journal. 2009, 11(3): 195-2.
    A 46-year-old woman with uremia and anemia received an IV infusion of iron dextran 100 mg twice a week while undergoing hemodialysis. The patient experienced headache every time 30 minutes after infusion initiation. She presented with generalized myalgia and arthralgia after the seventh infusion. Iron dextran injection was stopped and switched to an oral iron preparation. Her symptoms relieved one week later.
  • 病例报告
    Ren Aimin;Jiang Xiujuan;Bai Jing
    . 2008, 10(3): 214-2.

    A 30yearold woman with postpartum hemorrhage received sublingual misoprostol 600 μg. Fifteen minutes later, the patient suddenly developed dizziness, chill, breath holding, pale face, peripheral coldness, listlessness, and cold sweat. Physical examination showed a BP of 150/100 mmHg, P of 105 beats/min, R of 24 breaths/min. Misoprostolinduced anaphylactic reaction was suspected. The woman was given oxygen, antianaphylactic therapy immediately, and misoprostol was replaced with oxytocin for treating postpartum hemorrhage. Seven hours later, her symptoms were relieved.

  • 论著
    WANG Dong-xue;LIU Yu-qing;GAO Guan-nan;LIN Jing-yu;ZHANG Li-ming;LI Yi-shi
    . 2012, 14(6): 356-4.
    ObjectiveTo investigate the characteristics of adverse drug reactions (ADRs) caused by amiodarone tablets and injection in order to provide reference for safe drug use in clinical practice. Methods The reports of adverse reactions to amiodarone assessed as definite association, probable association and possible association in Center for ADR Monitoring of Beijing from January 2006 to February 2011 were collected. The clinical manifestations of ADRs, the ratio of servious adverse reactions, and outcome between the two dosage forms of amiodarone were compared. ResultsA total of 180 reports related to adverse reactions of amiodarone were collected, including 180 patients and 195 cases of adverse reactions. One hundred and eighty patients comprised 119 male and 76 female with average age of 64 years (2 months to 97 years). Twenty one patients had a history of adverse drug reactions. One hundred and ninty-five cases of ADRs included 151 cases (77.4%) of common ADRs and 44 cases (22.6%) of serious ADRs. Forty-six cases of ADRs included 13 (28.3%) serious cases associated with amiodarone tablets. One hundred and forty-nine cases of ADRs included 31 (208%) serious cases associated with amiodarone injection. The ratio of serious ADRs caused by amiodarone tablets was slightly higher than by injection, but the difference was not statistically significant (χ2=1.12,P=0.29). The clinical manifestations of ADRs caused by amiodarone tablets included increased hepatic enzymes (34.7%), hyperthyroidism or hypothyroidism (173%), cough,expectoration or dyspnea (109%), eruption (8.7%), headache, dizziness (4.3%), rhabdomyolysis (4.3%), allergy (22%), etc. The clinical manifestations of ADRs caused by amiodarone injection included increased hepatic enzymes (255%), phlebitis (27.5%), eruption (141%), allergy (81%), arrhythmia (6.0%), headache, dizziness (5.4%), a drop in blood pressure (4.7%), etc. There was not significant difference in the outcome of ADRs caused by amiodarone between the two dosage forms (χ2=8.18,P=0.09). Conclusion Amiodarone tablets and injection have some different adverse reactions, so different emphasis on ADR monitoring should be conducted. Guidance of medication and monitoring of relevant indicators should be strengthened, especially in patients receiving amiodarone tablets.
  • WANG He;WANG Chao;HUANG Guang-wei;CHEN Xing-wei;REN Ai-min;WANG Hong
    . 2013, 15(5): 280-2.
    A 71-year-old woman received an IV infusion of imipenem-cilastatin sodium 0.5 g every 8 hours for suspicious hospital-acquired infection. On day 3, the patient suddenly developed convulsion, opisthotonos, and trismus complicated within unconsciousness and shortness of breath. The symptoms lasted 2~3 minutes and this attack was relieved spontaneously without any treatment. About 15 minutes later, the above symptoms recurred and, 1~2 minutes later, she returned to normal status spontaneously. About 75 minutes and 2 hours later, the symptoms reappeared respectively lasting for 3-5 minutes and both diazepam and Xingnaojing(醒脑静) were given. About 50 minutes after the fourth seizure, the above-mentioned attack recurred and phenobarbitone was changed to an IV infusion of sodium valproate 400 mg via pump due to poor effect. About one hour later, the patient fell asleep quietly. The next day, imipenem-cilastatin sodium was discontinued and switched to latamoxef sodium and she did not experienced seizure anymore.
  • 病例报告
    Luo Jiaa;Wang Zhaob;Huang Chaob;Fu Lib;Cui Huab
    . 2010, 12(5): 349-3.
    A 36-year-old man with acute leukemia received a DA regimen (an IV infusion of daunomycin 100 mg once daily on days 1-3+an IV infusion of arabinoside 100 mg in the morning and 150 mg at night on days 1-7) . On day 6 of admission, a chest CT scan showed pericardial thickening. On day 11, the patient developed cough, shortness of breath, palpitation. His blood pressure was 145/105 mm Hg and heart rate was 120 beats/min. His heart sound was distant. Based on the findings of ultrasound cardiogram, pericardial effusion and acute cardiac tamponade were considered. He underwent pericardiocentesis immediately; however, the treatment failed. On day 12, the patient died from respiratory and circulatory failure.
  • 安全信息
    . 2011, 13(1): 37-1.
  • 病例报告
    . 2007, 9(2): 130-131.
    A 9-year-old boy with rheumatoid disease took nimesulide 50 mg twice daily. He developed asthenia, anorexia, and jaundice after 77 d of nimesulide therapy. Laboratory tests revealed the following values: Tbil 325.0 μmol/L, Dbil 216.9 μmol/L, ALT 916 U/L, ALB 35.5 g/L, γ-GT 750 U/L, and ALP 480 U/L. The boy lapsed into a coma on day 2 after admission. He received symptomatic therapy, and underwent phasmapheresis and continuous veno-venous hemofiltration treatment. The patient died from hepatic failure.
  • 病例报告
    Liu Ying;Chen Ranhong
    . 2007, 9(4): 282-283.
    Two old women developed abdominal colic,diarrhea,and arrhythmia after treatment with salmon calcitonin injection.The first patient,a 67-year-old woman was hospitalized with lumbar intervertebral disk degenerative disease and osteoporosis.She was given oral calcium gluconate 1 g twice daily and IM salmon calcitonin 50 IU once daily after an intradermal skin test was negative.Thirty minutes after injection,she developed abdominal colic and excreted yellow mushy stool.Two hours later,she developed palpitation.An ECG showed arrhythmia,paroxysmal ventricular tachycardia and abiogeny atrial premature beats.The symptoms lasted for 1 hour and then disappeared.After 3 days of administration,her symptoms were aggravated and she developed bilateral palpebral oedema.Then the regimen was changed to salmon calcitonin 50 IU once weekly.Two weeks later,these symptoms still existed.Salmon calcitonin was discontinued.Five days later,the symptoms relieved.An ECG showed normal.The second patient,a 65-year-old woman with lumbar intervertebral disk herniation and degeneration of bilateral knee joints was admitted.Laboratory test revealed her blood calcium level was 2.02 mmol/L.She was administered with IM salmon calcitonin 50 IU after a negative intradermal skin test.Two hours later,she developed abdominal colic,urinary frequency of micturition,urgency of urination,and diarrhea.An ECG showed sinus tachycardia.Six hours later,her symptoms relieved spontaneously.She did not receive the second injection.
  • 中药不良反应
    Liu Yan;Li Zhenzhou;Cao Yantao;Wang Wenyan
    . 2007, 9(3): 217-218.
    A 53-year-old woman with hyperthyroidism and atrial fibrillation for 17 years was given with Shuxuetong injection 8ml once daily by intravenously drip after admission because of marked dizziness and a history of thrombus. One year ago, the patient experienced cerebral infraction and then received warfarin 3.125 mg once daily. Her international normalized ratio (INR) ranged from 1.9 to 2.5 before admission. After 2 weeks of Shuxuetong infusion, her laboratory tests revealed the following values: prothrombin time (PT) 49.7 s, prothrombin activity (PT%) 12.3%, activated partial thromboplastin time (APTT) 74.8 s, INR 3.70, platelet count (PLT) 254×109/L. Shuxuetong injection was stopped, and the dosage of warfarin was changed from 3mg once daily to 1.5 mg once daily. Three days later, her PT and INR were decreased to 24.3 s and 1.91, respectively. The dosage of warfarin was returned to 3 mg once daily. The patient had no hemorrhage during the therapy.
  • 病例报告
    Zhang Fang;Chen Anjin;Yu Shunxiang
    . 2007, 9(6): 441-447.
    A 26-year-old woman with systemic lupus erythematosus accompanied by lupus nephritis and femoral head necrosis was treated with long-term use of prednisone 10 mg once daily.Mycophenolate mofetil 0.75 g twice daily was added to her regimen after hospitalization.Three days later,she developed a fever(T 39.0 ℃),nasal obstruction,pharyngalgia,and rude respiration in the lungs.She had a WBC count of 12.8×109/L and a neutrophil rate of 0.924.Mycophenolate mofetil was withdrawn and antondin was given by intramuscular injection.The next day,her body temperature returned to normal limits.Ten days later,the patient presented with prolonged high fever(T 39 ℃39.4 ℃) and the similar symptoms again following readministration of mycophenolate mofetil.After the cessation of the drug and symptomatic treatment,her fever gradually subsided.
  • 病例报告
    Li Wanhui;Li Dongyun;Hou Li
    . 2007, 9(6): 437-438.
    An 80-year-old woman with primary thrombocytosis received orally hydroxycarbamide 0.5 g thrice daily and IV breviscapine 50 mg once daily.On day 4,the dosage of hydroxycarbamide was then increased to 1.0 g thrice daily.After 5 days of treatment,the patient developed reddish skin rash on her chest and abdomen,with unbearable pruritus.Breviscapine was discontinued,and she was given anti-anaphylaxis therapy.And the dosage of hydroxycarbamide was decreased to 0.5 g thrice daily because her platelet count had declined from 1 120×109/L to 489×109/L.One week later,the patient's skin rash was markedly aggravated and fused to big patchy erythema,extending to the lumbus,back,hip,and limbs.Hydroxycarbamide was discontinued,and anti-anaphylaxis therapy was continued.The patient's skin rash resolved gradually.Afterward,she was treated with IV breviscapine,and the skin rash did not recur.
  • 药物评介
    . 1999, 1(3): 193-195.
  • Zhang Qingxia, Wang Yawei, Li Xiaoling, Wang Yuqin, Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, Chinese Pharmacological Society Professional
    Adverse Drug Reactions Journal. 2019, 21(1): 2-8. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.002
    The National Monitoring Network for Clinical Safe Medication was established in September 2012 by Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs (INRUD). As of December 31, 2018, a total of 40 873 cases of medication error (ME) were collected. In 2018, 11 761 cases of medication error (ME) from 177 hospitals in 24 provincial administrative regions were reported in China, of which 55 (0.47%) were classified as grade A, 9 419 (80.09%) as grade B, 2 001 (17.01%) as grade C, 179 as grade D ( 1.52%), 69 (0.59%) as grade E, 33 (0.28%) as grade F, 3 (0.02%) as grade G, 2 (0.02%) as grade H, and 0 as grade I; of which a total of 107 cases (0.91%) were determined as serious ME because of leading to patient harm. A total of 11 706 cases of ME (grade B-H) involved patients, including 6 668 males (56.96%) and 5 038 females (43.04%). These patients aged from 1 day to 105 years, of which 1 365 patients (11.66%) aged <18 years, 5 956 patients (50.88%) aged ≥18 to <60 years, and 4 385 patients (37.46%) aged <60 years. The top 3 drugs involved in serious ME were vancomycin hydrochloride, cefoperazone sulbactam, and methotrexate tablets. The 55 cases of class A ME did not involve people who triggered the ME and places where ME occurred in. In the 11 706 cases of class B-H ME, 7 128 (60.89%) were triggered by physicians, 2 920 (24.94%) by pharmacists, 513 (4.38%) by nurses, 124 (1.06%) by patients and their families, and 1 021 (8.72%) by other people; 4 369 (37.32%) occurred in the clinic, 3 625 (30.97%) in the pharmacy, 646 (5.52%) in the pharmacy intravenous admixture services, 230 (1.96%) in the nurse station, 48 (0.41%) at home, 1 (0.01%) in the community health service station, and 178 (1.52%) in other places. The top 3 contents of ME were wrong drug class, wrong total dose, and wrong single dose. The top 3 people who discovered the ME mostly were pharmacists, nurses, and patients and their families. The top 3 factors mainly causing ME were lack of related pharmacologic knowledge of medical staff, tiredness of medical staff, and presence of look alike and sound alike drugs.
  • Zhang Wenzhu, Zhang Yuanyuan, Zhao Yan
    . 2016, 18(2): 137.
    An 11-year-old boy with pneumonia received an IV infusion of azithromycin 0.375 g once daily and piperacillin sodium and tazobactam sodium 1.25 g every 8 hours after 3 days of azithromycin treatment. On day 8 of azithronycin treatment, the boy′s condition was improved markedly and azithromycin was stopped. On day 12, the boy developed fever and on day 14 his highest temperature reached 39.0 ℃. On day 12, piperacillin sodium and tazobactam sodium was withdrawn. On day 16, a large area of erythema multiforme appeared in the boy′s face, neck, and trunk. The rash increased gradually, fused into lamella, and emerged into blisters and rupture. Symptomatic treatments were given. Ten days later, the boy′s rashes was improved and was discharged.
  • Zang Ruohong;Yu Ran
    Adverse Drug Reactions Journal. 2010, 12(2): 143-2.
    A 54yearold women with anxious state received venlafaxine 75 mg and zolpidem tartrate 10 mg at bedtime. About 15 minutes later, the patient developed hallucination which disappeared after fell asleep. Subsequently, her symptoms aggravated. The adverse reactions were considered to be related to concomitant use of these two drugs, so zolpidem tartrate and venlafaxine were given separately and the interval time was over two hours. One week later, his symptoms subsided.
  • 病例报告
    Dong Yanfen;Li Qiuyan
    . 2007, 9(3): 206-206.
    A 76-year-old woman with diabetes mellitus received oral dimethylbiguanide for 10 years. Repaglinide 1mg twice daily and then rosiglitazone 4mg once daily were added to her regimen. Five months later, she developed sweat, weakness, short of breath, pale face, and so on. Laboratory tests revealed the following values: Hb 84 g/L, RBC 2.87×1012/L, HCT 0.26. She discontinued rosiglitazone and received symptomatic therapy. One month and a half later, the level of Hb was increased to 110 g/L, RBC and HCT were normal.
  • 论著
    ZHOU Li;JIANG Juan;WANG Yong;CHEN Ying;XU Li;CHONG Li-ming;YAN Han;WANG Hua;SUN Zu-yue
    . 2013, 15(2): 87-6.
    ObjectiveTo explore the feasibility and the best application regimen of cyclophosphamide as the positive control drug of embryo-fetal developmental toxicity test with rabbits and provide evidences for smoothly developing standardized reproductive toxicity tests.MethodsCommon New Zealand rabbits were used for the experiment and the date of mating success was day 0 of pregnancy (GD 0). Pregnant rabbits were divided into 4 groups including group A using cyclophosphamide (14 rabbits, given intragastric cyclophosphamide 18 mg/kg once daily from GD 6 to 20), group B using cyclophosphamide ( 11 rabbits, given subcutaneous injection of cyclophosphamide 25 mg/kg once daily from GD 10 to 13), group C using cyclophosphamide (12 rabbits, given intramuscular injection of cyclophosphamide 15 mg/kg once daily from GD 6 to 18, and solvent control group (12 rabbits, given intragastric normal saline 2 ml/kg once daily from GD 6 to 18). The general situation of the animals during drug use was observed. The pregnant rabbits were weighed in every group at GD 0, 3, 6, 10, 13, 15, 18, 20, 24, and 28 respectively and extrauterine weight gain was calculated. Serum of rabbits was taken at GD 5 and 28 respectively and the levels of testosterone, progesterone, and estradiol were tested. At GD 28, the rabbits were killed and fetal rabbits were taken. Corpora lutea count, implantation count, live birth rate, absorbed embryo rate, and stillbirth rate were recorded. Fetal rabbits were examined and aberration rates of appearance, internal organs, and bones were calculated.ResultsBody weight of rabbits in group A at GD 10 and 15 and body weight of rabbits in group B and C at GD 15 were all markedly lower than that in solvent control group(P<0.05 or P<0.01). Extrauterine weight gain in group A with use of cyclophosphamide was significantly lower than that in solvent control group[(-0.013±0.163)kg vs.(0208±0194)kg, P<0.01]. The differences of hormone levels at GD 28 and 5 showed the hormone levels changed markedly in group A while using cyclophosphamide and, compared with solvent control group, there were statistically significant difference in change range of estradiol and testosterone (P<0.01 or P<0.05) and there was no significant difference in change range of progesterone (P>0.05). There was no statistical significance in change range of hormone between group B, C using cyclophosphamide and solvent control group. Gross anatomy showed that there was no markedly abnormal manifestation of female rabbits. Live birth rate in group A and B using cyclophosphamide (65.1%, 19.2%) were markedly lower than that in solvent control group (93.1%) (all P<0.01). Absorbed embryo rates (17.4%, 539%) and stillbirth rates (174%, 26.9%) in group A, B using cyclophosphamide were markedly higher than that in solvent control group (4.2%, 2.8%) (all P<0.01). Aberration rates of appearance (60.6%, 93.3%, 16.1%), internal organs (62.9%, 93.3%, 25.9%), and bones (91.4%, 1000%, 61.7%) were markedly higher than that in solvent control group (0, 0, 3.0%) (all P<001).ConclusionIt was feasible that using cyclophosphamide as the positive control drug of embryo-fetal developmental toxicity test with New Zealand rabbit and the best regimen was intragastric cyclophosphamide 18 mg/kg once daily from GD 6 to 20 for 15 days continuously.
  • Zhang Huifang
    Adverse Drug Reactions Journal. 2009, 11(3): 164-2.
    A 38-year-old man took 3 metamizole sodium 0.5 g tablets himself for a cold. About 30 minutes later, the patient developed dizziness, chest distress, asthenia, and red petechiae and ecchymoses on his face, neck, trunk, and extremities. Three hours later, the patient was hospitalized with aggravated symptoms. An examination revealed a temperature of 37.2℃, a heart rate of 118 beats/min, a respiratory rate of 32 breaths/min, and a BP of 30/0 mm Hg. She experienced agitation, unconsciousness, general clamminess, incontinence of urine, and bilateral mydriasis. Routine blood tests revealed the following: WBC count 12.6×109/L with 80% neutrophils, platelet count 136×109/L. An ECG showed tachycardia and sinus arrhythmia. Despite treatment with adrenaline, dexamethasone, promethazine, and sodium bicarbonate, the resuscitation was unsuccessful and he died.
  • 中毒救治
    Wang Wen;Li Junjie
    . 2009, 11(4): 264-3.
    A 54-year-old man with chronic bronchitis received compound phenytoin sodium, ephedrine hydrochloride and theophylline tablets (each tablet contains phenytoin sodium 50mg, chlorphenamine maleate 1mg , ephedrine hydrochloride 5mg, caffeine 7.5 mg, theobromine 12.5 mg, theophylline 125 mg, and belladonna liquid extract 0.009 ml) for 1 year and more. His daily dose was unfixed; average daily dose was 6 tablets, sometimes increasing to 8 tablets per day. One year later, the patient developed perioral numbness, unsteady gait; coughing and choking while drinking, alalia, dysphagia, dizziness, blurred vision, and nystagmus. Brain MRI showed a mild brain white matter degeneration. Laboratory testing revealed a serum phenytoin level of 94.12×103μg/L. Phenytoin poisoning was diagnosed. The drug was discontinued and changed to theophylline sustainedrelease tablets; folic acid and vitamin B12 were given. After one week, the patient became able to walk independently and his dizziness relieved.
  • 专题讲座
    . 2002, 4(1): 38-42.
    药物治疗的疗效、剂量和毒性反应的个体和种族差异是临床实践和药物开发研究中的一个主要问题。在众多的影响因素中,遗传因素具有很重要的作用。本文主要从药动学和药效学两方面论述遗传因素对药物疗效和不良反应的影响,并综述了个体化用药存在的问题及前景。
  • 调查研究
    Du Min①;Guo Chao②;Tang Zhaojie①;Han Jinti①;Gao Wenbin①;Wang Huaijin①
    . 2004, 6(5): 306-308.
    Objective: To observe the toxic reactions caused by arsenious acid for solid carcinoma so as to evaluate its safety in clinical practice. Methods: 50 patients with cancer received two 10-day courses of intravenous infusion of arsenious acid 0.1mg/kg/day with a 5 day interval and the resulting toxic reactions were assessed. Results: The toxic reactions were found, occurring in blood(3 cases, 6%),heart(1 case, 2%)and gastrointestinal tract (8 cases, 16%). Conclusion: Arsenious acid was proved to be safe with a mild toxic reactions during its treatment for cancer.
  • Zhang Jinhua, Niu Peiguang
    Adverse Drug Reactions Journal. 2025, 27(1): 2-5. https://doi.org/10.3760/cma.j.cn114015-20241023-00112
    With the aging of the population and the increasing number of patients with throm- boembolic diseases, oral anticoagulants are more and more widely used. Anticoagulant-related nephropathy (ARN) is a significant adverse reaction in the treatment with oral anticoagulants, generally considered to be a form of acute kidney injury caused by excessive anticoagulation. The mechanisms involved may include glomerular hemorrhage, obstruction of renal tubules by red cell casts, and damage to tubular epithelial cells. Abnormalities in coagulation function and renal function are the main risk factors for ARN; older age, diabetes mellitus, and cardiovascular diseases such as hypertension and heart failure also increase the  risk of ARN occurrence. ARN should be managed based on individual patient characteristics. Benefits and risks of treatment should be carefully considered when choosing oral anticoagulants; renal function should be closely monitored during treatments to detect potential risks early. In case of ARN, it is advised to promptly adjust the anticoagulant therapy and provide symptomatic supportive treatments. In severe cases, treatments with methylprednisolone combined with hemodialysis can be employed.
  • Suo Wei, Jing Shan, Liu Wenfang, Lu Chunyan, Yang Kexu, Liu Jingyi,
    Adverse Drug Reactions Journal. 2022, 24(6): 295-299. https://doi.org/国家科技重大专项(2017ZX09304017)
    To evaluate the bioequivalence and safety of domestic and original pyrazinamide tablets under fasting condition. Methods A single center, randomized, open-label, two period self-crossover trial was conducted in healthy adult volunteers. The test preparation (T) of pyrazinamide tablets was produced by Taicang Pharmaceutical Factory and the reference preparation (R) was produced by A&Z Pharmaceutical Inc. (Pyrazinamide-). The healthy subjects were randomly divided into 2 groups and took the drugs for 2 times with different order in each group, which were R-T group (subjects took R on day 1 and then T on day 8) and T-R group (subjects took T on day 1 and then R on day 8). Pharmacokinetic parame- ters were used as endpoints to assess the bioequivalence. Peripheral venous blood samples (3-ml) were collected from subjects within 1 hour before taking the drug and at 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, and 210-minutes and 4, 5, 6, 8, 12, 24, 36, and 48-hours after taking the drug. Plasma was frozen after centrifugation of the blood samples. The plasma pyrazinamide concentrations were determined by a tandem liquid chromatography-mass spectrometry method and the main pharmacokinetic parameters such as peak concentration (Cmax) and the area under the concentration-time curve (AUC), including AUC from time zero (pre-dose) to the time of the last quantifiable concentration (AUC0-t) and AUC from time zero to infinity (AUC0-∞), were calculated. The test and reference preparations were judged as bioequivalence when the 90% confidence intervals (CI) of geometric mean ratios for AUC0-t, AUC0-∞, and Cmax all ranged from 0.80 to 1.25. Adverse events occurred in subjects during the trial were observed and recorded. Results A total of 24-healthy volunteers were enrolled in the trial, including 16 males and 8 females aged 18-50 years, with 12 in the R-T and T-R groups, respectively. All subjects completed the trial. After taking medicine under fasting condition, the 90%CI of the geometric mean ratios of Cmax, AUC0-t, and AUC0-∞ for the test and reference prepa- rations were 0.93-1.09, 0.98-1.03, and 0.98-1.03, respectively. During the trial, the incidence of adverse events was 25.0% (6/24) and 3 cases occurred after taking the test and reference preparations respectively, which were grade 1 in severity. Conclusion The domestic and original pyrazinamide tablets were bioequivalence and with good safety when taken under fasting condition.
  • Ye Chao, Wang Zhaohui
    Adverse Drug Reactions Journal. 2021, 23(11): 614-616. https://doi.org/10.3760/cma.j.cn114015-20210118-00074
    A 74 year old female patient underwent percutaneous coronary intervention due to acute non ST segment elevation myocardial infarction. Iodixanol 160 ml was injected intravenously during the operation. Angiography showed that coronary artery disease was type B and and no drug adverse reactions occurred during the operation. About 12 hours after the operation, the patient developed nausea, vomiting, and blindness; about 30 hours after the operation, she developed memory decline, irritability, and anxiety with a serum creatinine of 174 μmol/L. Her serum creatinine was 134 μmol/L before operation. After consultation with the ophthalmologists and neurologists and the cranial CT examination (showing increased density of the tentacles, a small amount of suspected subarachnoid hemorrhage, and softening lesions in bilateral basal ganglia) during disease progression, it was considered to be contrast encephalopathy. Symptomatic treatments such as IV infusions of methylprednisolone 80 mg twice daily and torasemide 10 mg once daily and fluid replacement were given. Two days later, the patient had improved vision and memory and consciousness recovered; 3 days later, her vision and spirit returned to normal.
  • 论著
    Luo Rong;Su Yingying
    . 2008, 10(5): 0-0.

    Objective: To compare the efficacy and safety of two different doses of mannitol 20% for treating the patients with acute moderate-to-severe stroke. Methods: Fifty-four patients with acute moderate-to-severe stroke (massive cerebral infarction or large-volum spontaneous intracerebral hemorrhage) were randomly divided into the high-dose group (27 cases) and the low-dose group (27 cases) from march 2007 to march 2008. The patients in the highdose group were given an IV infusion of 250 ml of mannitol 20% every 6 hours for 5 days, then changed to 125 ml of mannital 20% every 6 hours for 5 days. The patients in the low-dose group were given an IV infusion of 125 ml of mannitol 20% every 6 hours for 10 days. The efficacy was evaluated by Glasgow Coma Scale (GCS) score and the incidence of brain hernia on day 1, 3, 5, 7, and 10 of therapy. No changes or no increase in GCS scores, no brain hernia, or brain hernia improvements were regarded as effectiveness. The safety was evaluated by the type and incidence of adverse reactions. The prognosis was assessed by case fatality rates on day 7 and 90 and modified Rankin Scale (mRS) score on day 90 after stroke onset. Results: The efficacy was confirmed in 20 cases (81.5%) in the highdose group and 23 cases (85.2%) in the lowdose group. There was no statistically significant difference between the two groups (P>0.05). In safety comparison of the high-dose group and the lowdose group, the incidences of acute renal damage, electrolyte abnormality, and osmolality disturbance were 11.1% versus 3.7%, 40.7% versus 44.4%, and 29.6% versus 14.8%, respectively. No acute heart failure was observed. There was no statistically significant difference in the type and incidence of adverse reactions between the two group (P>0.05). In comparison of prognosis, on day 7 after onset, the case fatality rate was 18.5% in both groups. On day 90 after onset, the case fatality rate was 22.2% in the high-dose group and 25.9% in the low-dose group. No statistically significant difference was observed in the case fatality rate between the two groups (P>0.05). On day 90 after onset, 77.8% of patients had poor prognosis (mRS 4~6 scores) in the high-dose group and 70.4% of patients in the low-dose group. There was no statistically significant difference in the prognosis between the two groups. Conclusion: Low-dose mannitol appears to be effective and safe for treating the patients with acute moderate-to-severe stroke.

  • 学术研讨
    . 2004, 6(6): 368-373.
    本文根据临床工作体会并结合近年研究报道,对抗乙肝病毒药物临床应用的有关问题,包括治疗时机、药物的选择、疗效的判断、疗程以及特殊人群用药等问题进行探讨。
  • 论著
    CAO Yan-jun;FANG Fang;LIU Min;CAI Hao-dong
    . 2013, 15(2): 69-4.
    ObjectiveTo explore the cause of drug resistance in patients with chronic hepatitis B during pregnancy and the management policy.MethodsThe clinical data of 20 pregnant women with chronic hepatitis B received lamivudine (LAM) or telbivudine (LdT), developed drug resistance during pregnancy, and delivered full-term newborns from January 1,2007 to December 31,2012 in Beijing Ditan Hospital were collected and analyzed retrospectively. The main indicators of analysis included the situation of antiviral drug use before and after pregnancy, the occurrence time of drug resistance and the restriction measures during pregnancy, HBV-DNA load, liver function, maternal and neonatal outcomes.ResultsLAM group comprised 12 patients with age of 26 to 38 (31±3) years, received LAM 100 mg/d for 15 to 8 years before pregnancy. Of them, 3 patients had received entecavir for 2 years and then changed to LAM. LdT group comprised 8 patients with age of 27 to 34 (31±2) years, received LdT 600 mg/d for 2.0 to 4.5 years. Of them, a patient had received entecavir for 2 years and then changed to LdT. The drug resistance occurred during 0-12, 13-27, and 28-40 weeks of pregnancy in LAM group in 1, 2, and 9 cases, in LdT group in 1, 1, and 6 cases, respectively. A total of 15 (75%) patients developed drug resistance during 28-40 weeks of pregnancy. Of 12 patients in LAM group, 4 substituted tenofovir (TDF) 300 mg/d for LAM, 3 received LAM and added adefovir dipivoxil after 28 weeks of pregnancy, 4 received LAM continually and added adefovir dipivoxil after childbirth, another one substituted telbivudine for LAM but was not effective and added adefovir dipivoxil after childbirth. Of 8 patients in LdT group, 2 substituted TDF 300 mg/d for LdT, 6 received LdT continually and combined with adefovir dipivoxil 10 mg/d after childbirth. Twenty pregnant women were all singleton and had full-term natural labor. In LAM group, a newborn′s venous HBV DNA load was 1.56×106 copies/ml and diagnosed as intrauterine infection associated with mother′s drug resistance. In LdT group, a newborn developed annexal ear on the right side, another newborn had intracranial bleeding and anemia, both were not correlated with drug and mothers′drug resistance. Twenty newborns were followed-up for 2 to 57 months, all had normal growth and development.ConclusionsDrug resistance monitoring during pregnancy should be applied for chronic hepatitis B women receiving antiviral therapy, especially for the patients receiving antiviral therapy for a long time before pregnancy. The drug resistance may lead to liver disease aggravation and increase the risk degree of hepatitis B virus mother-to-infant transmission. When drug resistance occurred, the liver funcion should be monitored regularly and the therapy should be changed in the following circumstances: fully informed the risk, weighed the advantage and disadvantage, and signed informed consent. TDF is the best choice for LAM or LdT-resistant patients during pregnancy.
  • CAI Hao-dong
    . 2013, 15(3): 157-4.

    Hepatitis B virus (HBV) in a dormant or latent state in patients with cancer may be reactivated when the patients receive antineoplastic combined chemotherapy protocols or immunosuppressive agents therapy. Then, the patients develop symptoms of hepatitis, accompanied by HBV DNA levels exceeding more than 10 times of basic level or absolute HBV DNA levels >20,000 IU/ml. Due to HBV reactivation, 4.5%-8.1% patients dead from liver disease and 23.3%-71.0% of patients′chemotherapy program have to be discontinued or changed. The mechanism of HBV reactivation may be that antineoplastic agents and immunosuppressive agents suppress the function of T cells and natural killer cells and massive viral replication is induced subsequently. The HBV reactivation in cancer patients is in relation to the stages of HBV infection, the type of malignancy, and the chemotherapy protocols. Lamivudine and other nucleos(t)ide analogues could be used to prevent and treat effectively HBV reactivation in cancer patients. Patients with cancer should be screened for HBV infection before receiving chemotherapy. A preventive use of nucleos(t)ide analogues is effective to decrease the incidence and severity of HBV reactivation in high-risk patients.

  • LI Sheng-nan;MA Qing;CHEN Hai-ping
    . 2013, 15(5): 269-4.
    ObjectiveTo preliminarily evaluate the kidney′s safety of cinepazide maleate injection.MethodsThe clinical data of patients who were hospitalized in Medical Care Center of Beijing Friendship Hospital during August 2011 to July 2012 and had complete medical records, aged ≥60 years and received cinepazide maleate injection for cardiovascular and cerebrovascular diseases were collected and analyzed retrospectively. The serum creatinine elevated ≥26.4 μmol/L, or increased 1.5 times of baseline, or urine volume<0.5 ml/(kg·h) were the diagnostic criteria of kidney injury after received cinepazide maleate injection.ResultsData of a total of 489 patients were collected. They comprised 377 male with average age of (83±7) years (60 to 106 years), and 112 female with average age of (81±8) years (63 to 100 years). There were 160 cases (32.7%) aged between 60 to 80 years and 329 cases (67.3%) over 80 years. There were 265 (54.2%) infections, 223 (45.6%) chronic kidney diseases, 125 (25.6%) diabetes, 32 (6.5%) cancers, and 24 (4.9%) with critical illness in 489 patients. One hundred and fifty cases received combined treatment with angiotensin-converting enzyme inhibitors/angiotensin Ⅱ receptor blockers (ACEI/ARB) at the same time. The treatment method of cinepazide maleate injection was 320 mg, IV infusion once daily and the average time of administration was 12 days (2 to 68 days) for all patients. Fourteen (2.9%) patients developed kidney injury, they comprised 12 male(3.2%) and 2 female (1.8%), one case aged between 60 to 80 years (0.6%), 13 cases aged over 80 years (4.0%). The level of serum creatinine was 54-217 μmol/L [(105±48) μmol/L] before treatment and increased to 86-276 μmol/L [(142±57) μmol/L] 2 to 15 days (mean of 6 days) after receiving cinepazide maleate injection. The incidence of kidney injury in patients who were over 80 years was higher than that in patients aged between 60 to 80 years (P=0.043). The incidence of kidney injury in patients with chronic renal insufficiency was higher than that in the patients without chronic renal insufficiency (P=0.002). No cases developed the symptoms of oliguria or anuria in 14 patients. Nine patients (64.3%) had the records of dynamic monitoring of kidney function. Of them, cinepazide maleate injection was withdrawn immediately in 6 patients after developing renal damage and three patients continued to receive cinepazide maleate injection until the end of therapeutic course. The result of dynamic monitoring of kidney function showed that the levels of serum creatinine in above-mentioned 9 patients returned to the baseline level 3-12 (an average of 6 d) days after drug withdrawal. Five patients (35.7%) did not undergo the dynamic monitoring of kidney function. Of them, one patient stopped cinepazide maleate injection and four patients continued the medication. All the patients who developed kidney injury did not receive any drug treatment, did not develop irreversible kidney injury and did not bring adverse effects on the primary diseases.ConclusionsCinepazide maleate injection may cause kidney injury in elderly patients. Dynamic monitoring of kidney function should be given in patients at advanced age with chronic kidney disease.
  • 中药不良反应
    Yang Yepeng;Wang Xiaohui
    . 2007, 9(4): 292-293.
    Two psychotic patients developed leucopenia during treatment with Qingkailing injection for upper respiratory tract infection.The first patient,a 30-year-old woman with paranoid personality disorder received long-term treatment with venlafaxine 150 mg daily and quetiapine fumarate 0.2 mg daily.On day 3 after admission,she occurred upper respiratory tract infection.Laboratory test revealed a WBC count of 5.7×109/L.She started receiving Qingkailing injection 40 ml + sodium chloride injection 0.9% 500 ml once daily by intravenous infusion.The next day,her WBC was decreased to 3.2×109/L.After 5 days of administration with Qingkailing injection,her WBC was decreased to 2.0×109/L.On day 6 after the cessation of Qingkailing injection,her WBC was increased to 4.7× 109/L.On reexaminations,the WBC counts were in normal limits.The second patient,a 35-year-old woman with bipolar affective disorder developed upper respiratory tract infection after 2 months of admission.She was administered intraven ously with Qingkailing injection 30 ml + glucose injection 5% 500 ml once daily and WeiC Yinqiao 2 tablets thrice daily.On day 5,her symptom of upper respiratory tract infection disappeared and her body temperature returned to normal.But her WBC was decreased from 7.8×109/L to 3.1×109/L.Qingkailing injection was discontinued.One week later,her WBC was increased to 5.8×109/L.During 3 months of follow-up,the WBC was normal.
  • 中药不良反应
    Wang Ying
    . 2007, 9(4): 293-294.
    Two women with coronary heart disease and angina pectoris were administered intravenously with Ciwujia injection 60 ml.After 2 to 3 minutes of therapy,they suddenly developed dyspnoea,cyanose of the lips,polypnea,rhonchi in the lungs.Ciwujia injection was stopped immediately.After administration of oxygen,IV glucocorticoid,and other symptomatic therapy,the patient recovered gradually.
  • 病例报告
    Zhang Chao;Zhai Suodi
    . 2007, 9(6): 426-426.
    A 55-year-old woman received oral terbinafine 250 mg once daily for onychomycosis.About one month later,she developed decreased sensitivity to salty and bitter taste.More than one month after continuation of terbinafine,she had a total loss of the ability to taste.Terbinafine was discontinued.Her taste sense did not recover during 20 days of follow-up.
  • ADR监测与防治
    I.Ralph Edwards
    . 2000, 2(2): 103-105.
    WHO国际药物监测合作个C主任I.RalPh Edwards教授和MohalnedH Farah博士在怪国药物临床安全性学术会助(杭州,2000年4月)上作了学术报告,征得本人同意,译成中文发表于本刊,以飨读者。
  • Wang Lijun, Zhan Hanqiu
    ObjectiveTo explore the etiology, clinical features and outcome of drug-induced liver failure (DILF) for reference to safe drug use in clinical practice.MethodsThe information of patients with DILF, who were admitted to the Department of Liver Disease in Beijing Ditan Hospital Capital Medical University from January 1, 2007 to December 31, 2016 was collected using hospital information system and analyzed retrospectively.ResultsA total of 108 patients were entered investigation, including 46 males (42.6%) and 62 females (57.4%), aged 11 to 81 years with a median age 48 (35, 61) years. Of the 108 patients with DILF, 48 patients (44.4%) received Western medicines,43 patients (39.8%) received traditional Chinese medicines, 13 patients (12.0%) received Western medicines combined with traditional Chinese medicines, and 4 patients (3.7%) received medicines with no definite classifications. In 61 patients receiving Western medicines or Western medicines plus traditional Chinese medicines, the top 3 Western medicines were antituberculosis drugs (29.5%, 18/61), nonsteroidal anti-inflammatory drugs (18.0%, 11/61) and anti-infective agents except antituberculosis drugs (14.7%, 9/61). Of 56 patients receiving traditional Chinese medicines or traditional Chinese medicines plus Western medicines, 15 had osteoarthrosis, 15 had skin diseases(53.6% in total, 30/56). Ten patients had no definite diseases, who only took traditional Chinese medicine for recuperation or health care, accounting for 23.3% of the 43 patients receiving traditional Chinese medicines. Among the 108 DILF patients, 44 patients (40.7%) were diagnosed as having subacute liver failure, 41 patients(38%) as acute liver failure, 21 patients(19.4%) as acute-on-chronic liver failure, and 2 patients(1.9%) as chronic liver failure; according to their pathologic features, 66 patients(63.4%) had hepatocyte liver injury, 6 patients(5.8%) had cholestasis liver injury, and 32 patients(30.8%) had mixed type liver injury. The length of hospitalization of 108 patients was 1-183 days, and the medium length of hospitalization was 22 (10, 44) days. In addition, 33 patients (30.6%) died during their hospitalization, 3 patients (2.8%) were judged to be cured, 40 patients(37.0%) were improved, and 32 patients(29.6%) were invalid at the time of their discharge. The MELD scores of patients in the effective treatment group (cure and improvement) and ineffective treatment group (ineffectiveness and death) were (24.2±6.7) and (36.4±12.3), respectively. And the difference was statistically significant(t=-5.9245, P<0.001). A MELD score cut-off values of ≥32.3 (sensitivity 60.0%, specificity 93.0%) was determined as having invalid or death risk for patients with DILF.ConclusionsWestern medicines that might induce liver failure mainly include anti-infective drugs(especially antituberculous drugs) and nonsteroidal anti-inflammatory drugs. Traditional Chinese medicines and their preparations as well as heath care products were also an important cause of DILF. The major pathological features of DILF were hepatocyte liver injury. The prognosis of patients with DILF is poor. MELD score might be used to predict the prognosis of DILF.
  • 安全用药
    Ji Liwei;Li Kexin
    . 2011, 13(2): 90-5.
    Combined oral contraceptives are the most widely used contraceptives preparations, they contain two sex hormone: progestogen and estrogen. COC may cause cardiovascular diseases. Epidemiological evidence suggests that the dyslipidemia may be associated with these diseases. The mechanism of this phenomenon is not entirely clear; the elevation of blood triglyceride levels may be related to a decrease in lipolytic activity of liver and triglyceride removed as well as an increase in blood insulin levels. Different preparations of COC should be alternated if possible for a longterm use of the contraceptives in women of childbearing age, and blood lipid levels should be monitored during the period of COC use.
  • 安全用药
    Tian huijun;Zhang Jiatang*
    . 2009, 11(5): 335-5.
    Zidovudine is a nucleoside analogue, which is the first-line drug for the treatment of AIDs. Since 1987, zidovudine associated myopathy has been sometimes reported. The incidence is 2%~18%. The clinical presentation is myalgia, muscle weakness and creatine kinase elevations. The mechanism of zidovudine-induced myopathy might be linked to the damage of skeletal muscle mitochondria. The prevention and treatment include: (1) on the treatment, the low-dose of zidovudine should be initially given and then gradually increasing to regular dosage. (2) the levels of creatine kinase should be monitored during the treatment. (3) if zidovudineinduced myopathy is confirmed, the drug should be stopped immediately, and corticosteroids, coenzyme Q10 , and carnitine may be given.
  • 论著
    Chen Jinyue①;Qin Yaochun①;Li Haiying①;Wen Jun①;Liang Yu②
    . 2006, 8(6): 414-417.
    Objective:To study the effect of Xuesaitong injection on hemolytic degree of human erythrocytes in order to provide evidence for its clinical safe use. Methods:The test solutions were prepared by diluting Xuesaitong injection (containing total saponin of Sanqi 100 mg) to 25 mg/ml,1 6.7 mg/ml,and 10 mg/ml. The hemolytic degree of human erythrocytes caused by the test solutions was measured by spectrometry and routine macroscopy. Results:The hemolytic reaction was caused by the test solutions of 25 mg/ml and 16.7mg/ml,but it was not caused by the test solution of 10 mg/ml. Conclusion:The hemolytic reaction of Xuesaitong injection is related to its concentration. Therefore,Xuesaitong injection should be diluted to appropriate con-centration before administration,and the concentration of solution no more than 10mg/ml is safe.
  • 专题讲座
    . 2001, 3(1): 62-65.
    “需治疗人数”(number needed to treat,NNT)被定义为绝对危险度减少值的倒数,它是指为预防1例不良事件发生,临床医师在一段时间内应用某一疗法需治疗的患者数。NNT及其扩展指标NNTus(有效且无副作用)和NNHUF(不仅无效且发生副作用)具体直观,贴近医生和患者的实际要求,可对药物疗效及其不良反应进行综合评价,还可利用它们方便地进行成本-效益分析,是评价药物不良反应的较好指标。
  • 病例报告
    . 2003, 5(6): 399-399.
  • Fang Zhenwei, Zhao Yiru, Zhang Ying, Lin Yang
    Adverse Drug Reactions Journal. 2024, 26(1): 25-32. https://doi.org/10.3760/cma.j.cn114015-20230406-00252
    Objective To evaluate the efficacy and safety of hybutimibe in the treatment of hypercholesterolemia. Methods Relevant databases and clinical trial registration websites at home and abroad were searched (up to March 27, 2023), and randomized controlled trials (RCTs) of hybutimibe in the treatment of hypercholesterolemia have been collected. Patients in the trial group were given hybutimibe with or without other hypolipidemic agents, and those in the control group were given placebo or other hypolipidemic agents as same as that in the trial group. The primary outcome in effectiveness was the change rate of low-density lipoprotein cholesterol (LDL-C). The primary outcomes in safety were incidences of overall adverse events (AEs), serious AEs (SAEs), the trial termination due to AEs, and trial drug-related AEs. The secondary outcome in safety was incidence of the major AE reported in ≥ 2 trials. Meta-analysis was performed using RevMan 5.4-software. The effect sizes of counting data were expressed by the relative risk (RR) and its 95% confidence interval (CI). The effect sizes of measurement data were expressed by mean difference (MD) and its 95%CI. Results A total of 4 RCTs and 1-488 patients were entered in the analysis, including 952 patients in the trial group and 536 in the control group. The results of meta-analysis showed that at 8-12 weeks of treatment, the decrease rate of LDL-C in the trial group (hybutimibe 20 or 10-mg daily with or without atorvastatin 10-mg daily) was significantly greater than that in the control group (hybutimibe 20-mg daily: MD=-13.36%, 95%CI: -15.28% - -11.44%, P<0.001; hybutimibe 10-mg daily: MD=-10.80%, 95%CI: -14.90%- -6.71%, P<0.001); at 52 weeks of treatment, the average decrease rate (from baseline) of LDL-C in the trial group (hybutimibe 20 or 10-mg combined with atorvastatin 10-mg daily) was significantly greater than that in the control group with atorvastatin 10-mg daily monotherapy (-41.92% and -39.34% vs. -31.56%, all P<0.001); the incidences of overall AEs [47.94% (338/705) vs. 49.75% (202/406),RR=0.99, 95%CI: 0.87-1.12], SAEs[2.64% (16/606) vs. 2.79% (10/358), RR=1.19, 95%CI: 0.53-2.66], trial termination due to AEs[4.11% (29/705) vs. 4.68% (19/406), RR=0.67, 95%CI: 0.17-2.65], and trial drug-related AEs [12.38% (75/606) vs. 11.45% (41/358), RR=0.87, 95%CI: 0.37-2.06] were similar between the 2 groups at 8-12 weeks of treatment (all P>0.05). Conclusion Hybutimibe could effectively reduce LDL-C level in patients with hypercholesterolemia, with good medication safety.
  • Hao Jie, Yuan Xiaotong, Li Yuwang, Peng Fangchen, Li Yuanping
    Adverse Drug Reactions Journal. 2022, 24(6): 329-331. https://doi.org/10.3760/cma.j.cn114015-20211222-01293
    A 53-year-old male patient with stage Ⅳ diabetic nephropathy received an IV infusion of torasemide 40-mg which was put into a small pot once daily for edema of both lower limbs. On the 3rd day of medication, the dose of torasemide was increased to 80-mg/d according to the doctor′s advice due to poor diuretic effect. Eight hours later, the patient developed bilateral visual occlusion and blurred vision. Ophthalmological examination showed normal visual acuity and intraocular pressure in both eyes. The loss of binocular visual field caused by torasemide was considered. Then the drug was discontinued. After 2 days of drug withdrawal, the patient′s visual field loss disappeared. Because of the patient′s disease condition, IV infusion of torasemide 40-mg which was put into a small pot once daily was given again for 6 days, and the patient did not develop symptoms of visual field loss. The change of visual field might be related to the high dose of torasemide.
  • 学术讨论
    . 2002, 4(2): 102-106.
    可疑药物不良反应的因果评价是复杂的鉴别诊断过程。导致临床不良事件的原因有药物的,也有非药物的。为了正确识别造成特定不良事件的真正原因,需要用科学、可靠的方法排除许多不确定因素的干扰。贝叶斯法以贝叶斯定理为基础,根据特定药物不良反应病例的资料,估算药物原因的先验概率和后验比,推测具有最大可能性的原因。本文系统介绍了贝叶斯法的原理、基本概念和在药物不良反应因果评价中的实施步骤。
  • 调查研究
    Long Ling
    . 1999, 1(2): 102-103.
    Objective: To make a follow-up observation of patients with nasoseptal perforation caused by beclometa-sone nasal spray, and put forward preventive measures. Methods: 178 cases of inpatients having applied more than 2 canisters of the drug from 1996 to 1999 were continually observe with rhinoscope for 36 months, and the pathological process of the nasal septum was clinically analyzed. Results: In the 178 cases, there were 12 cases (6.74% ) of mucosal ischemia of the nasal septum, 6 cases (3.37%) of thinned mucosa of nasal septum, 3 cases (1.69% ) of nasal septum mucosal defect, and 5 cases (2.81 % ) of nasal septum perforation. Conclusion: Operate strictly in accordance with the directions, and change the methods for holding the canister to spray the drug into nose; the drug is contraindicated or used with great care for patients before or after nasal septum correction is performed; monthly examination of nasal septum is necessary to prevent perforation for patients using the drug continually.
  • 综述
    . 2006, 8(6): 401-406.
    抗癫痫药的合理使用包括对癫痫发作类型和综合征的正确诊断,选择合理的单药或多药治疗,剂量应个体化,进行血药浓度监测及对测定结果的正确解释。关注抗癫痫药在特殊人群中的合理安全使用,预防抗癫痫药的过处理以及与患者充分的沟通和定期随访等,最大限度地提高抗癫痫药的疗效,降低其不良反应,以提高癫痫患者的生活质量。
  • 药物评介
    . 2006, 8(3): 227-230.
  • 学术研讨
    . 2004, 6(6): 366-368.
    房颤的抗凝治疗历来是一个值得关注的问题,房颤患者经过抗凝治疗后可以明显降低血栓和脑卒中的发病率。本文根据近年研究,对房颤华法林抗凝治疗的适应证与注意事项、如何监测及调整剂量、抗凝过度的处理等问题做一概述。
  • 病例报告
    Cai Shaoping;Chang Xiujuan;Liu Ze
    . 2008, 10(5): 0-0.

    A 54-year-old man with hepatitis B and posthepatic cirrhosis was administered with an IV infusion of ademetionine 1,4-butanedisulfonate 1 000 mg dissolved in 250 ml of glucose 5% for hyperbilirubinemia. Five minutes later, the man developed chest distress, short breath, dyspnea, cyanosis of lips, and bilateral wheezing. He had a body temperature of 37.0 ℃, a respiratory rate of 30 breaths/min, a heart rate of 120 beats/min, and a BP of 125/82 mmHg. Ademetionine 1,4-butanedisulfonateinduced anaphylactic reaction was suspected. The medication was withdrawn immediately. His condition improved after nasal oxygen supplementation and adrenalin administration. Author comment: anaphylaxis induced by ademetionine 1,4-butancdisulfonate is uncommon, and care should be taken in clinical use of the drug.

  • 滥用误用
    Wang Mengran;Zhang Jian
    . 2008, 10(2): 123-5.

    Doping is a generic name of prohibited drugs and methods defined by the International Sport Organization. Doping includes anabolic agents, peptide hormones, β2 receptor agonists, diuretics, narcotics, etc. Peptide hormone is a newer kind of doping, which includes five types: erythropoietin (EPO), human growth hormone (hGH), insulinlike growth factor-1 (IGF-1), gonadotrophins, insulin, and corticotrophins. Peptide hormones are endogenous substances of human body, so it is difficult to detect them. However, abuse and misuse of peptide hormone is harmful to human health. For example, EPO may cause anaphylaxis, hGH may cause acromegaly, IGF-1 may cause acute hypophosphatemia, gonadotrophins may cause precocious puberty in male, insulin may cause blurred vision, corticotrophins may cause amenorrhea in female, etc.

  • 论著
    Yan Benyong;Zhang Feng;Sun Li;Liang Juncheng;Fan Huaying;Shi Jie;Xu Guozhu;Deng Yanping
    . 2011, 13(3): 137-5.
    Objective: To study the tolerance of Yanshen oral solution and to determine its safe dosage. Methods: A total of 38 healthy volunteers (aged 18-32 years) entered the tolerance study and received a single-dose regimen or a multi-dose regimen in clinical trials. The single-dose regimen was an open study, 26 subjects were divided into 5 groups: the 5 ml dose group (n=4), the 10 ml dose group (n=4), the 20 ml dose group (nn=6), the 30 ml dose group (n=6), and the 40 ml dose group (n=6). The multiple-dose regimen was a randomized, double-blinded, and placebo-controlled study, 12 subjects were divided into 2 groups: the Yanshen group (n=6) and the placebo group (n=6). The ratio of male to female in each group was 1 to 1. During the study periodthe subjectsvital signs and adverse events were observed and recorded; routine blood, urine, and stool tests, blood biochemical tests (including the levels of K+, Na+, Ca2+, Cl-, glutamic-pyruvic transaminase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, urea nitrogen, creatinine, etc.) , and electrocardiogram (ECG) were performed and all the results were statistically analyzed. Results: There were no differences in the age, gender, body weight and height among the 4 single-dose groups (the 40 ml dose group was canceled because of intolerance) and between the 2 multiple-dose groups. The maximum tolerance dose was 30 ml in the single-dose regimen and 20 subjects completed the study. A dose of 20 ml thrice daily for 7 consecutive days was selected for the multiple-dose regimen study. There were no statistically significant changes in vital signs, the routine blood, urine, and stool tests, and blood biochemical tests in all subjects after receiving the single-dose or multiple dose regimens. In the single-dose regimen study, sinus bradycardia occurred in 1 subject each in the 20 ml dose and 30 ml dose groups. All subjects receiving the multi-dose regimen had normal ECG. The main adverse reactions after drug administration were mild nausea and vomiting. In the single-dose regimen study, nausea occurred in 1 subject in the 5 ml dose group and 3 subjects in the 20 ml dose group, vomiting occurred in 1 subject in the 5 ml dose group and 2 subjects in the 20 ml dose group; in addition, all 6 subjects in the 30 ml dose group developed nausea and vomiting. In the multiple-dose regimen study, mild nausea and vomiting occurred in 2 subjects in the Yanshen group; however, the symptoms improved 30 min after developing adverse reactions. Conclusion: Yanshen oral solution could be well tolerated in a dose of 20 ml thrice daily with no severe adverse reactions.
  • ZHANG Ai-wu;WANG Yi
    . 2013, 15(6): 357-2.
    A 60-year-old female patient with hypetension received an IV infusion of cattle encephalon glycoside and ignotin injection 6 ml in 0.9% sodium chloride injection 250 ml for fluctuation of blood pressure, dizziness, numbness of the limbs, and blurred vision. About 30 minutes later, the patient developed skin pruritus, red and swollen eyelids, red papules in her chest, urticaria rashes in her head and neck, and chest tightness. The infusion was immediately stopped and symptomatic treatment was given. The next day, her symptoms of skin worsened and gradually developed into erythema multiforme-type drug eruption. An IV infusion of dexamethasone, vitamin C, and calcium gluconate, oral levocetirizine, and calamine lotion for topical application were given for 10 days. And then her erythema completely subsided.
  • 病例报告
    Shen Ge;Jiang Zefei;Song Santai;Wu Shikai;Wang Tao;Zhang Shaohua;Lu Xinyou;Zeng Min
    . 2007, 9(6): 413-419.
    A 44-year-old women with breast cancer was treated with oral tamoxifen 20 mg/d as adjuvant endocrine therapy after breast operation and chemotherapy.Three months later,her levels of ALT,AST,and γ-GT increased.After 6 months of medication,her liver function examination showed the levels as follows:ALT 396 U/L,AST 278 U/L,and γ-GT 211 U/L.After liver-protective treatment,her hepatic function returned to normal limits.Then she was treated with anastrozole and goserelin instead of tamoxifen,and liver dysfunction did not recur.
  • 临床论著
    Su Lia;Ji Bingxina;Dong Huiqingb;Hui Wuhana;Zhang Pub;Xu Juana
    . 2010, 12(3): 153-4.
    Objective: To restrospectively analyze the efficacy and safety of autologous peripheral blood stem cell transplantation(APBSCT) in treatment of patients with secondary progressive multiple sclerosis(MS). Methods: Between 2001 and 2010, 41 patients with secondary progressive multiple sclerosis in Xuanwu Hospital of Capital Medical University entered the study. They comprised 31 women and 10 men with mean age of 36 years. All patients received SC G-CSF 5 μg/kg for five days to mobilize hematopoietic stem cells. Peripheral blood mononuclear cells were collected by cell separator, and CD34+ cells selected by CliniMACS in 28 cases. The mononucleur cell or CD34+ cells were stored at -80℃ in refrigerator. The patients received a BEAM conditioning regimen comprising becenum (camustine) 300 mg/m2×1 d, etoposide (teriposide) 150 mg/m2×4 d, cytosine arabinoside 200 mg/m2×4 d, and melphalan 140 mg/m2×1 d. After the conditioning regimen, the CD34+ cells or PBMC preserved at low temperature were restored, and were infused intravenously. The degree of recovery in the neurological function after APBSCT was evaluated with EDSS and the adverse reactions were evaluation with Common Terminology Criteria for Adverse Events V 3.0. Results: Two patients were lost to followup. The followup duration to 39 patients after APBSCT ranged from 6 to 100 (mean 51) months. Of them, 16 patients’state was improved, 8 stable, and 15 recurrence and progression. The cumulative 100month progressionfree survival rate was 55.5%. The adverse reactions due to APBSCT were as follows: after the conditioning regimen, the neutrophils and platelet counts in 41 patients were <0.5×109/L and <25×109/L, respectively, and hematopoietic reconstitution was achieved after supportive treatment in all patients, 37 patients developed diarrhea; 3 patients presented with tenipeideinduced anaphylaxis; 26 patients experienced infections, including 19 cases of neutropenia with fever, 2 cases of soft tissue abscess, 2 cases of septicemia,1 case of pulmonary fungal infection,1 case of skin infection, and 1 case of alimentary tract infection. Six patients developed engraftment syndrome. There was no death associated with APBSCT. Conclusion: APBSCT is a relatively effective and safe therapy for the secondary progressive multiple sclerosis; however, closely observing the possible occurrence of adverse reactions during the use of APBSCT is necessary.
  • 中药不良反应
    Zhang Junzhong
    . 2007, 9(3): 215-215.
    A 47-year-old women with esophagitis took Zengshengping 3 tablets thrice daily. Six months later, she developed nausea and jaundice. Laboratory tests revealed the following values: Tbil 122.2 μmol/L, Dbil 108.0 μmol/L, ALT 581 U/L, AST 277 U/L, GGT 125 U/L. The patient's condition improved after withdrawal of the drug and 8 days of treatment with diammonium glycyrrihizinate,Yinzhihuan injection, and inosine tablets. The values of laboratory tests were as follows: Tbil 94.7 μmol/L, Dbil 81.2 μmol/L, ALT 162 U/L, AST 142 U/L, GGT 125 U/L. Her symptoms improved obviously
  • Shi Tianlu, Zhang Yonghuang, Li Yu, Zhang Lei, Deng Mingying, Jiang Ling
    . 2016, 18(5): 321.
    ObjectiveTo evaluate the relationship between MTHFR C677T and A1298C gene polymorphism  and the adverse reactions of blood system induced by methotrexate (MTX).Methods The  databases of PubMed, Science Direct, Web of Science, CNKI, VIP, and Wanfang Database from the inception to August 2015 were searched. The reports about the the relationship between MTHFR C677T and A1298C gene polymorphism and the adverse reactions of blood system induced by MTX were searched. The quality of enrolled articles were evaluated according to the Strengthening the Reporting of Genetic Association Studies(STREGA). The software Review Manager 5.3 was used for the Meta-analysis. The results were expressed as odds ratio (OR) and 95% confidence interval (CI).ResultsA total of 21 papers related to MTHFR C677T comprised 1 846 patients and 15 papers related to MTHFR A1298C comprised 1 317 patients were enrolled into the Meta-analysis.  The result of evaluation of the quality of the reports was reliable (all scores ≥3). The results of the Meta-analysis showed that compared with the patients who carrying MTHFR C677T (CC) , the risk of arrest of bone marrow induced by MTX in the patients who were carrying MTHFR C677T (CT+TT) significantly increased [52.1 % (88/169) vs. 55.7% (123/221), OR=0.63, 95%CI: 0.40,  0.97, P=0.04 ]. Among the patients who were carrying MTHFR A1298C (AC+CC), the risk of aleucocytosis induced by MTX in the patients who were carrying MTHFR A1298C (AA) significantly increased [51.6 % (83/161) vs. 43.8% (84/192), OR=1.68, 95%CI: 1.07, 2.63, P=0.02].ConclusionsThe polymorphisms of MTHFR C677T and A1298C are associated with the adverse reactions of blood system induced by MTX in the patient with ALL. The patients who were carrying MTHFR C677T  (CT+TT) or MTHFR A1298C (AA) were easy to develop arrest of bone marrow or aleucocytosis, respectively.
  • 病例报告
    Li Ling;Song An;Song Guangyao
    . 2014, 16(4): 252-2.
    A 74-year-old male patient with coronary atherosclerotic heart disease given clopidogrel hydrogen sulfate, aspirin, Tongxinluo(通心络), coenzyme Q10, atorvastatin calcium, vitamin E and vitamin C after undergoing coronary artery stent implantation. He stopped taking atorvastatin calcium because of the lipid-lowering effect was not good and switched to rosuvastatin calcium 10 mg once daily by himself. The patient′s blood glucose level elevated within four months. His fasting blood glucose ranged from 6.5 to 7.8 mmol/L and postprandial blood glucose ranged from 7.7 to 10.5 mmol/L. Seven months later, his fasting blood glucose peaked at 12.5 mmol/L, and postprandial blood glucose peaked at 16.0 mmol/L, glycosylated hemoglobin level was 9.6%. He discontinued rosuvastatin calcium by himself. Three months later, the fasting blood glucose and postprandial blood glucose were down to 5.9 mmol/L and 7.4 mmol/L, glycosylated hemoglobin level was back to 6.6%.
  • Yang Jie, Yu Lei, Zou Dan, Lu Jingli, Wang Jin, Zhang Xiaojian
    . 2016, 18(5): 385.
    A 51-year-old female patient with breast cancer received tamoxifen citrate (10 mg, twice daily) for 40 months after surgery. Routine physical examinations 1 and 8 months after drug withdrawal showed mild fatty liver. Abdominal CT examination showed severe fatty liver about 13 months after drug withdrawal. The liver function was normal and no related symptoms appeared. Liver biopsy was performed and histopathological examination showed that about 60% liver cells appeared macrovesicular steatosis and approximately 30% liver cells in microvesicular steatosis. Severe fatty liver was confirmed. IV in fusion of phosphatidylcholine 10 ml and glutathione 1.2 g once daily were given. Three days later, the above-mentioned drugs were stopped. At 18 months of follow-up, the abdominal ultrasonography examination showed no further development in the patient′s fatty liver.
  • 病例报告
    Li Hua;Zhao Hongyan;Zhao Junyan
    . 2010, 12(1): 65-1.
    A 38yearold woman was hospitalized for druginduced liver damage due to ketoconazole. After admission, the patient received an IV infusion of compound glycyrrhizin injection 100 ml ( containing glycyrrhizin 200 mg ) in 5% glucose 250 ml for two weeks. Subsequently, she developed generalized edema which was marked in her both lower extremities. Her blood pressure was within 136~140/90~100 mm Hg and the level of serum potassium was 2.56 mmol/L. The drug was discontinued, spironolactone tablets and controlled-release potassium chloride tablets were given. Seven days later, her symptoms improved. She was discharged after 26 days of hospitalization and had no discomfort at 2week follow up.
  • . 2013, 15(6): 319-1.
  • DUAN Dan-dan;QI Xiao-le;ZHANG Ya-jun
    . 2013, 15(3): 175-2.

    A 59-year-old women received 2 capsules of Xuezhitong capsules three times daily due to hyperlipoidemia. Before treatment laboratory test showed the following values: total cholesterol 8.43 mmol/L, triglycerides 3.86 mmol/L, LDL cholesterol 5.28 mmol/L, alanine amino-transferase 37 U/L, aspartate aminotransferase 33 U/L,γ-glutamylacyl transferase (γ-GT) 46 U/L, and total bilirubin 10.9 μmol/L. Four weeks after receiving Xuezhitong capsules, the parameters of serum lipid were improved but γ-GT values increased to 166 U/L. Xuezhitong capsules were stopped. γ-GT values decreased to 86 U/L 2 months later and 59 U/L 3 months later. The patient self-medicated with Xuezhitong capsules again for 4 weeks and then the drug was withdrawn. Liver function test revealed γ-GT 159 U/L. Two months later γ-GT decreased to 92 U/L.

  • 病例报告
    Zhou Hong;Chen Shanshan
    . 2010, 12(5): 346-3.
    Five in-patients with pulmonary thromboembolism, 3 males and 2 females aged 46-67 years, received anticoagulant therapy with SC nadroparin calcium 0.7-0.8 mL (7175-8200 IU) 12-hourly or dalteparin sodium 0.2 mL (5000 IU) 12-hourly. Three to eight days after the treatment, all of them developed hepatic dysfunction. Laboratory tests showed the following results of liver enzymes: AST 48-157 U/L,ALT 92-288 U/L, and γ-GT 52-248 U/L. The medicines were discontinued and the patients were treated with liver protective therapy.Three to five days later, their liver enzyme levels improved.
  • 安全用药
    Wen Yingqi
    . 2009, 11(3): 188-3.
    Sorafenib is a multikinase inhibitor, which is used in the treatment of advanced renal cell carcinoma and many other types of solid tumors. One of the most common adverse reactions to sorafenib is handfoot skin reaction (HFSR). The incidence of HFSR is 33.8%. The clinical manifestations of HFSR are numbness, tingling, erythema, swelling, blister, dry skin, chap, and desquamation on the hands and feet. The mechanisms of sorafenibinduced HFSR is unclear, but may be related to inhibition of VEGF, PDGF, c-kit, RET, and FLT3. Prevention and treatment of HFSR include dosage adjustment according to the intensity of HFSR and symptomatic treatment.
  • 病例报告
    Wang Changyuan;Qin Jian;Sun Changyi;Wang Jing
    . 2008, 10(2): 135-2.

    A 66yearold man with lumbago was treated with nimesulide 100 mg twice daily. He developed jaundice and pruritus after 7 days of treatment, followed by dyspnea, oliguria, hepatorenal failure gradually. Serologic tests for viral hepatitis A, B, and C were negative. Nimesulideinduced multiorgan dysfunction syndrome was suspected. After admission, he was treated with sultamicillin, methylprednisolone, glutathione, and continuous venovenous hemofiltration. The patients condition including hepatic and renal functions progressively worsened accompanied with gastrointestinal tract hemorrhage. He died on day 4 after admission.

  • 论著
    Wang Xiukun;Zhao Yong;Liang Aihua;Liu Ting;Li Chunying;Tang Xilan;Yi Yan;Tang Hongjun;Ye Zuguang
    . 2008, 10(2): 81-5.
    Objective:To observe the acute toxicity of climbing groundsel herb from different producing areas in our country. Methods: The climbing groundsel herb for experimental study was from 6 different producing areas: Guangxi, Hubei, Jiangsu, Zhejiang, Sichuan, and Henan. One hundred and forty Kunming adult mice were divided into 7 groups (20 mice in each group): the Guangxi group, the Hubei group, the Jiangsu group, the Zhejiang group, the Sichuan group, the Henan group, and the control group. The mice in the 6 experimental groups were perfused to the stomach with water extracts of different climbing groundsel herbs (1 ml of extracts was equivalent to 2 g of climbing groundsel herb), and mice in the control group was perfused with distilled water. All mice were given 30 ml/kg, twice (at interval of 6 hours) daily. The observations on toxic reactions and deaths in mice were performed within 14 days. The body weight and feeding amount for mice were weighed every three days. The liver indices were measured and pathological examination was performed. In addition, young mice, adult mice, and rats were perfused with water extracts of Henan climbing groundsel herb in different concentration for measuring the LD50. Results: No death was found in mice of the Guangxi and Hubei groups. The mortality rates of mice in the Jiangsu, Zhejing, Sichuan, and Henan groups were 20%, 15%, 30%, and 100%, respectively. An autopsy showed that a markedly swollen and dark red liver with necrotic focus was found in living and dead mice. A microscopic examination revealed more binuclear, macronuclear, and irregular nuclear cells in the liver, inflammatory cellular infiltration, multiple calcific foci, and dilatation and stasis in hepatic central veins and focal hepatic sinus in living mice. The mices liver indices markedly increased in the Zhejing and Sichuan groups. The changes in body weight and feeding amount in the living mice of experiment groups were not found. The young mice, adult mice and rats LD50 for Henan climbing groundsel herb was 48.51 g/kg, 4615 g/kg, and 98.41 g/kg, respectively. Conclusion: The toxicity of climbing groundsel herb varies with different producing areas. No marked toxicity was found in climbing groundsel herb from Guangxi and Hubei. There is some degree of toxicity in climbing groundsel herb from Jiangsu, Zhejiang, Sichuan, and Henan. The climbing groundsel herb from Henan is the most toxic one among these herbs, its toxicity is related to species variation, and the tolerance in rates is greater than that in mice.
  • 病例报告
    Chen Dongyanga;Wang Huibinga;Gu Xinb;Jiang Qinga;Yuan Taoa; Xu Zhihonga
    . 2009, 11(2): 135-2.
    Patient 1, a 79yearold man, was hospitalized with fracture of right femoral neck. The patient started receiving SC lowmolecularweight heparin calcium 3 075 U in the evening of the day before undergoing total hip joint replacement. Cefotaxime sodium, sodium aescinate, and omeprazole were given and a drain was inserted after surgery. On day 3 after surgery, the drain was removed, then a total of 400 ml of bloodstained fluid flowed from his drain site within 2 hours. Coagulation test revealed the following: PT 146 s, APTT 54.7 s, TT 13.7 s, FIB 3.2g/L, and AT Ⅲ 68.6 s. Routine blood test showed a Hb level of 76 g/L and a PLT count of 188×109/L. IM thrombin 1 000 U was given immediately. Six hours later, IM thrombin 1 000 U, an IV infusion of fresh plasma 800 ml and 5 units of erythrocyte suspension were administered. On day 3 after surgery, lowmolecularweight heparin calcium was discontinued. The following day, a repeated coagulation test remained normal. Blood oozing from incision site did not recur.Patient 2, a 74yearold woman was hospitalized with fracture of right femoral neck. She received SC lowmolecularweight heparin calcium 3 075 U 12 hours before undergoing total hip joint replacement. During the surgery, the patient experienced more blood oozing. Coagulation test revealed an APTT of 58.7 s. IV protamine 30 mg and IM thrombin 1 000 U were given immediately. Lowmolecularweight heparin calcium was stopped after surgery. Her wound did not showed marked blood oozing on day 2 after surgery.
  • 专题讲座
    . 2001, 3(2): 136-139.
  • 不良事件
    . 2005, 7(2): 146-146.
  • 中药不良反应
    Liu Qing;Wen Liping
    . 2009, 11(1): 70-2.
    A 17yearold girl received a Jiuhuazhichuang suppository for her anal fissure. About 23 minutes after starting administration with the suppository, the girl abruptly developed pruritus, lip swelling, and wheal of various sizes on her skin. After hospitalization, she was treated with IM dexamethasone 10 mg, IV 10% calcium gluconate 10 ml diluted in 50% glucose 20 ml. Her Jiuhuazhichuang suppository was eliminated with rectal administration of a Kaisailu (20 ml of a glycerin solution). Later, she experienced generalized asthenia and unconsciousness, her pulse rate was 108 beats/min, her respiratory rate was 30 breaths/min, and her BP was 70/48 mmHg. IM 0.1% adrenaline 0.3 ml and IV fluids were given immediately. Four hours later, the symptoms completely disappeared. An examination showed a pulse rate of 70 beats/min, a respiratory rate of 18 breaths/min, and a BP of 120/80 mm Hg.
  • 病例报告
    Guo Guihong;Yuan Zhen'e
    . 2008, 10(3): 217-2.
    A28yearold woman took fluconazol 150 mg for monilial vaginitis. Three hours later, the woman developed purplish red erythema of varying sizes (1.5~6 cm2) with swelling and pruritus on bilateral armpits, elbows, and toes. The patient had a previous history of adverse drug reactions, and had developed drug eruptions at the abovementioned same site after taking aspirin and sulfonamide. Therefore, the erythema was diagnosed as fixed drug eruption. Fluconazal was withdrawn. After treatment with loratadine 10 mg once daily, vitamin C 0.2 g twice daily, and external glucocorticosteroid cream. One week later, her swelling and prurities resolved, and residual pigmentation was left.
  • 安全信息
    . 2009, 11(3): 224-2.
  • 病例报告
    Wang Yanhui
    . 2008, 10(5): 0-0.

    A 41-year-old hypertension. One week later, the man developed hyposmia, which was aggravated gradually. Three months later, his dosage of nifedipine was changed to 20 mg twice daily. Meanwhile, enalapril and carvedilol were added to his regimen. He developed a complete loss of olfaction on day 3 after receiving the dosage regimen. An examination of nasal cavity showed nasal mucosa congestion and both inferior turbinate hypertrophy. Obstructive anosmia was suspected. His olfaction returned to normal status on day 6 after discontinuation of sustainedrelease nifedipine tablets. The other antihypertensive drugs were continued. The olfactory disturbance did not reappear.

  • 安全用药
    Gao Xuan;Li Zhiping
    . 2011, 13(3): 165-4.
    Gefitinib is a selective inhibitor of the tyrosine kinase activity of the epidermal growth factor receptor, which is used in the treatment of non-small-cell lung cancer. Gefitinib can cause interstitial lung disease (ILD). The mean time to gefitinib-induced ILD onset is 24-42 days. The incidence of ILD is 0.44%-2.0%, and the mortality rate of ILD is 0.12%-0.5%. The clinical manifestations are dyspnea, respiratory distress, dry cough, and cyanosis. Diffuse infiltration shadow and alveolar interstitial shadow were seen on chest imagine studies. Advanced age, male, smoking history, a previous history of ILD, and the long duration of treatment are th risk factors for gefitinib-induced ILD. During gefitinib therapy, chest imaging should be performed regularly. Once ILD occur, gefitinib should be discontinued, and high-dose IV glucocorticoid, oxygen inhalation therapy, and anti-infective therapy should be administered. The prognosis is generally good.
  • 综述
    Wang Shujun;Qian Jiaming
    . 2014, 16(6): 359-3.
    The incidence of drug-induced pancreatitis (DIP) is not reported accurately. If DIP is not diagnosed, suspected drugs will be taken continuously by patients and relapsed pancreatitis will occur accompanied with painfulness and unnecessary medical expenses. There are no unified classification methods for drug-induced pancreatitis in the present. The most commonly used classification methods are 3-kind-method and 4-kind-method, which are divided by the number of patients and provocative tests or the number of patients, provocative tests, the incubation period, and the exclusion of other causes, respectively. The mechanisms of DIP are direct toxicity and idiosyncratic reactions. Diagnosis of DIP is difficult because it has no special clinical manifestations and specific diagnostic markers. For patients diagnosed as idiopathic pancreatitis, a careful examination for the patients′ medication histories is necessary. Treatments for DIP are similar to acute pancreatitis and discontinuation of the suspected drugs is the key point.
  • Yao Danlin, Mu Hongmei
    . 2015, 17(4): 307.
    A 45 year-old woman with acute bronchitis  took moxifloxacin 0.4 g orally by herself. She  developed pruritus and rubefaction on the whole body, edema in the face, hoarseness, vomiting, abdominal pain, and diarrhea 5 minutes after taking the medicine. About 25 minutes later, she developed clouded vision and became unconscious. She was given an intravenous injection of methylprednisolone 120 mg, and rapid intravenous drip of 0.9% sodium chloride injection 1 000 ml. But the abdominal pain did not alleviate. She developed colporrhagia one hour after taking the medicine. The result of abdominal ultrasound examination showed no obvious abnormity. Then she was given an intramuscular injection of meperidine 100 mg. About 30 minutes later, her abdominal pain was relieved. Twenty-four hours after receiving moxifloxacin, her colporrhagia was stopped. The patient had a similar experience of morbidity, diagnosis and therapy one month ago.
  • Wu Liyao, Sheng Xiaoyan, Ma Lingyue, Zhao Xia,Zhou Ying,Cui Yimin
    . 2015, 17(3): 181.
    ObjectiveTo explore adverse reactions induced by cyclosporine in patients with rheumatic diseases.MethodsClinical data of patients diagnosed with rheumatic diseases and treated with cyclosporine ( 3 d) in Peking University First Hospital from January 2013 to December 2014 were collected and analyzed retrospectively.ResultsData of a total of 46 patients in accordance with inclusion criteria were collected. Of them, 20 patients were diagnosed with systemic lupus erythematosus, 8 with dermatomyositis, 6 with sicca syndrome, and 4 with undifferentiated connective tissue diseases and etc. There were 2-13 kinds of combination drugs in this 46 patients. In addition to cyclosporine treatment, all of them were treated with glucocorticoid, 39 with non-steroidal antiinflammatory drugs, 12 with other immune suppressants, 20 with antibiotics, 15 with hypoglycemic drugs, 14 with antihypertensive drugs, and 8 with proton pump inhibitors at the same time. Of the 46 patients, 21 developed 33 patient-time adverse drug reactions and the incidence was 45.7%. Of the 21 patients, 14 patients developed 1 kind of adverse reaction, 3 patients developed 2 kinds of adverse reactions, 3 patients developed 3 kinds of adverse reactions, and 1 patients developed 4 kinds of adverse reactions. The incidence of different adverse reactions were as follow: infection 21.7%(10/46), urea nitrogen increase 10.9%(5/46), gastrointestinal reactions 10.9%(5/46), blood glucose increase 8.7%(4/46), blood pressure increase 8.7%(4/46), and liver injury 6.5%(3/46), dizziness and headache 2.2%(1/46), and hypoleucocytosis 2.2%(1/46). Severe adverse reactions occurred in 5 patients and in 4 of them improved after treatments with drug withdrawal or symptomatic therapy, including recurrence of pulmonary tuberculosis in 2 patients, aggravation of original interstitial lung disease in 1 patient, and peptic ulcer in 1 patient; the fifth patient with repetitive infection died of primary disease after drug withdrawal. Moderate adverse reactions in 8 patients improved after symptomatic treatments. Mild adverse reactions in 7 patients were self-relieved and not clear in 1 patient because of discharge.ConclusionsThe incidence of adverse reactions induced by cyclosporine is high. The incidence of infection is higher and more severe. During the treatments, infection, blood glucose, blood pressure, and liver and renal function should be monitored to ensure medication safety.
  • Deng Jianxiong, Wang Zhifei, Xie Yanming, Li Bing, Ma Lin, Wang Jincun, Zhang Xinjing, Wu Hui
    . 2018, 20(1): 15.
    To revalue the post-marketing safety of Xiyanping injection.MethodsThe research was carried out by prospective hospital based monitoring method. The leading organizations were Guangdong Medicine Adverse Reaction Monitoring Center and Chinese of Basic Research in Clinical Medicine Institute. The participants were 21 hospitals in 6 provinces/municipality directly under the Central Government which located in Northeast China, Central China, South China, and Southwest China. Monitoring objects were all patients who used Xiyanping injection when they were hospitalized. The set sample size was not fewer than 30 000 cases. Every patient who used Xiyanping injection filled in Xiyanping injection screening card (screening card) by research staff manually. The patient who developed adverse reactions (ADR) after using Xiyanping injection filled in Xiyanping injection monitoring table (monitoring table) by clinical pharmacist manually. All the hospital should report the screening card and the monitoring table to Guangdong Provincial Drug Reevaluation Report Management System (Reevaluation Report Management System) every month.The monitoring study ended when the number of screening cardrunning up to 30 000. The reported data were collected and the incidence rate of Xiyanping injection were calculated. The clinical characteristics of adverse reactions were analyzed.ResultsData were collected through the Reevaluation Report Management System till January 23, 2015. The monitoring study ended. Five hospitals stopped participation in the monitoring study because of discontinuity of cases′ data from March to August, 2013.  A total of 30 759 screening cards and 23 monitoring tables which were from 16 hostipals were collected finally. There were 18 295 (59.48%) male and 12 464 (40.52%) female in 30 759  patients. Of them the number of patients whose age <4 years were 16 501 (53.64%). The patients′primary diseases were mainly respiratory disease, infectious disease, parasitic disease, and digestive system disease. All the patients used Xiyanping injection with standard doses according to the instructions. Two thousands and eight hundred-ten (9.02%) patients did not use prescriptive menstruums. There were 28 353 patients (90.98%) who were treated with combined drugs at the same time.The top 4 combined drugs were antimicrobial agents, electrolyte acid-base balance and nutrition drugs, respiratory system drugs, and digestive system drugs successively. Twenty-three of 30 759 patients developed ADR related to Xiyanping injection, the ADR incidence rate was 0.75‰, 95% confidence interval (CI) was 0.47‰ to 1.12‰. The results of deciding the relevance of ADR with Xiyanping injection as "in all probability", "possible" and "unable to judge" were 12 (51.27%), 10 (43.48%) and 1 (4.35%) cases, respectively. Thirty-four ADR soccurred in 23 patients.The main clinical manifestations of ADR were erythra (19 cases), pruritus (7 cases), shiver with cold (4 cases), fever (3 cases), and cyanotic lips (1 case). The degree of adverse reactions were all general.Nineteen patients improved or recurred on the same day of drug withdrawal and treatment of antianaphylaxis. Three patients improved or recured within 2 days. One patient improved on the day 14 of drug withdrawal and treatment of antianaphylaxis.ConclusionThe incidence of ADR due to Xiyanping injection from 2012 to 2015 were lower and have better safety.
  • Ren Peipei, Fu Ying
    . 2016, 18(1): 65.
    A 68-year-old female patient self-medicated with 1 tablet of compound paracetamol and amantadine hydrochloride (each tablet contained acetaminophen 250 mg, amantadine hydrochloride 100 mg, calculus bovis factitious 10 mg, caffeine 15 mg, and chlorpheniramine maleate 2 mg) because of nasal discharge and cough on the second day of trabeculectomy with covering of amniotic membrane in her right eye. About 30 minutes after administration, she developed dizziness, nausea, vomiting, urinary incontinence, itching on her arms and calves, and pale. Her blood pressure was 80/44 mmHg and heart rate was 90 beats/min. Anti-allergic treatments, blood volume expansion, and oxygen mask were given. Thirty minutes later, her blood pressure increased to 90/62 mmHg. The patient′s symptoms gradually alleviated 2 hours later and the blood pressure increased to 106/69 mmHg 6 hours later.
  • Lu Qin
    Adverse Drug Reactions Journal. 2010, 12(1): 62-2.
    A 33yearold woman received an IV infusion of pazufloxacin 0.5 g in 0.9% sodium chloride 500 ml. After infusion of 60 ml, the patient developed headache, dizziness, coldness, involuntary head shaking, downward eye deviation, trismus, mild convulsion of extremities, signs of clawhand, and confusion. Pazufloxacin was withdrawn and promethazine and dexamethasone were given. Forty minutes later, her symptoms disappeared, but she could not remember what happened then. She was discharged after 24 hours of hospitalization and there was no recurrence at oneweek follow up.
  • 病例报告
    Zhang Li;Duan Lifang
    . 2007, 9(3): 201-202.
    An 18-year-old female with postoperative malignant glioma was administered with phenytoin sodium 100mg thrice daily for prevention of epileptic seizure. Sixteen days later, she presented with a fever (38.2℃). The patient was given paracetamol. The next day, she developed erythema, blister, and a high fever (40℃). Paracetamol was stopped immediately. The patient still had blister, and progressed to anabrosis of conjunctiva and oral mucosa. She had a WBC count of 15.59×109/L and an ALT level of 87 U/L. Phenytoin sodium was withdrawn and the woman was treated with glucocorticoids, symptomatic and supportive therapy. After 45 days of therapy the patient recovered and was discharged.
  • 病例报告
    Guo Lai;Zhang Gaihua
    . 2008, 10(5): 0-0.
    A 62-year-old woman with a suspected pulmonary infection developed chill, chest distress, short breath and hyperpyrexia two hours and a half after receiving an IV infusion of azithromycin 0.5 g, and then dysphoria and delirium occurred. ECG examination showed fast atrial fibrillation. Her symptoms resolved after anti-anaphylactic and symptomatic treatment. Azithromycin was withdrawn and changed to amoxicillin. The above-mentioned symptoms did not recur.
  • 病例报告
    Mao Sufang
    . 2008, 10(4): 0-0.

    34-year-old woman with bronchitis was infused with 200 ml (0.4 g) of azithromycin sodium chloride injection intravenously. The patient presented with tongue tip numbness after receiving 80 ml of the infusion. A tongue examination did not reveal any abnormalities. Two hours after the infusion, her tongue tip numbness disappeared. The next day, her tongue tip numbness recurred after the second infusion of azithromycin. On day 3, azithromycin was replaced with ceftriaxone and the symptom did not recur.

  • Liu Chunyu;Xie Zhiyi;Qin Long
    Adverse Drug Reactions Journal. 2009, 11(3): 201-3.
    A 26yearold man was hospitalized with myalgia in his lower extremities, chest distress and palpitation. On admission, he had oliguria, dark urine, a BP of 80/50 mm Hg, and a heart rate of 120 beats/min. Laboratory test results were as follows: CK 906 U/L, CK-MB 100 U/L, ALT 310 U/L, AST 369 U/L. Urinalysis revealed the following results: WBC count 1493.2/μl, RBC count 193.1/μl, cast 65/μl, pathologic cast (+), bilirubin (++), occult blood (++), protein (++), specific gravity 1.030. Blood gas analysis revealed a pH of 6.9 and a PO2 of 64 mm Hg, which was considered to be metabolic acidosis. An IV infusion of sodium bicarbonate 5% was given. A review of his medical history showed that he had a history of chronic hepatitis B and received telbivudine 600 mg once daily for 11 months and more. Laboratory test showed his blood myoglobin level was more than 500 ng/ml. The man was diagnosed with telbivudineassociated rhabdomyolysis and treated with hemofiltration, methylprednisolone, and symptomatic therapy. Telbivudine was discontinued and changed to entecavir. The second day of hospitalisation, he had a peak CK level of 1300 U/L, a CKMB level of 61 U/L, a ALT level of 512 U/L, and a AST level of 579 U/L. Four days later, his urine volume normalized, renal function gradually returned to within normal ranges. On day 12 of hospitalisation, his myalgia in the lower extremities markedly improved and his muscle strength recovered to grade Ⅳ; he had a CK level of 144 U/L, a CK-MB level of 15.1 U/L, a ALT level of 57 U/L, a AST level of 34 U/L, and normal electrolyte levels.
  • 药物警戒
    . 2002, 4(4): 227-230.
  • ADR监测
    . 1999, 1(1): 45-47.
    介绍同仁医院6年来开展ADR监察工作的经验和目标,包括建立院ADR监察工作小组,完善ADR监察报告工作制度,对医务人员的宣传教育等,以达安全合理用药,保证医疗质量。
  • 综合报道
    . 2002, 4(5): 312-314.
    本文对博莱霉素肺毒性反应的发生机制、临床表现、危险因素及其防治措施作一综合报道。博莱霉素所致的肺毒性反应的发生率约占使用含博莱霉素化疗患者的2%~46%,因肺毒性死亡的患者约占所有用博莱霉素治疗患者的3%;博莱霉素的肺毒性是严重的、有时甚至是致命的副作用。一些危险因素可能会增加博莱霉素的致病率或致死率。降低博莱霉素的累积剂量可能是目前最有效的预防方法。
  • 综合报道
    . 2000, 2(3): 180-181.
    本文概述了近年来文献报道氟喹诺酮类药物在临床应用中,引起消化系统、循环系统、血液系统、神经系统、过敏等不良反应,以及对软骨发育的影响,提示临床使用这类药物时尚须慎重。
  • SARS防治
    . 2003, 5(4): 222-223.
  • WHO信息
    . 2002, 4(4): 277-277.
  • 监测交流
    . 2005, 7(2): 141-142.
  • 病例报告
    Li Zhaowu;Li Yafang;Liu Xingfen
    . 2009, 11(1): 55-1.
    A 38yearold woman was hospitalized with cholecystolithiasis and acute episode of chronic cholecystitis. The woman was given an IV infusion of ceftriaxone sodium 2.0 g dissolved in 250ml of sodium chloride injection 0.9%. After about 150ml of the infusion, she experienced tetany and dysphoria. Her blood calcium level was 1.85 mmol/L; her blood sodium level, blood potassium level, liver and renal function, and blood glucose level were within normal limits. Ceftriaxone sodium was withdrawn immediately. Antianaphylactic and symptomatic treatment showed no improvement in her symptoms. The patient was administered with 10 ml of calcium gluconate 10% diluted in 20ml of glucose 25% by intravenous injection. Fortyfive minutes later, the abovementioned symptoms resolved gradually; eight hours later, her blood calcium level incrcased to 2.35 mmol/L. The next day, ceftriaxone was replaced with ampicillin and the described above symptoms did not reappear.
  • 病例报告
    Huang Lin;Li Yuzheng;Zheng Jianyong;Jiao Meng;Xiao Shasha;Han Ling
    . 2009, 11(4): 294-3.
    A 14yearold girl with dilated cardiomyopathy and a 3yearold boy with endocardial fibroelastosis developed alopecia during receiving carvedilol and other 5~6 medications. Patient 1 received an initial dose of carvedilol 1.25 mg once daily, which was gradually increased to 5 mg thrice daily. One month later, the patient developed marked hair loss, then the dosage was adjusted to 5 mg twice daily. Her alopecia obviously improved. Patients 2 received an initial dose of carvedilol 0.5 mg once daily, which was gradually increased to 3.3 mg twice daily. The boy developed marked hair loss, then the dosage was adjusted to 2 mg twice daily. His alopecia significantly improved.
  • Tan Yunduxi;Li Yuzhen
    Adverse Drug Reactions Journal. 2009, 11(4): 267-2.

    A 56-year-old and mycophenolate mofetil 500 mg once every 12 hours. Blood tacrolimus level was 6.8 ng/ml. The patient was treated with piperacillin sodium-tazobactam sodium and metronidazole for low-grade fever. On day 8 of hospitalization, 1 fluconazole 200 mg capsule twice daily was added to his regimen for prevention of fungal infections. Blood tacrolimus level was 7.9 ng/ml. On day 10 of fluconazole therapy. He developed bradykinesia, left gaze deviation of his eyes, tic of upper limbs, trismus, and confusion. Blood tacrolimus level was 12.4 ng/ml. Tacrolimus was adjusted to 1.5 mg once daily. His symptoms relieved. On day 35 of hospitalization, blood tacrolimus level was 7.8 ng/ml.

  • 病例报告
    Duan Liling
    . 2009, 11(1): 66-1.
    A 22yearold man underwent debridement and suture for wound on his right forehead. After surgery, the man was administered with desensitization injections of tetanus antitoxin (TAT) due to a positive TAT skin test. Fifteen minutes after the first intramuscular injection of TAT 150 U, he presented with mild itching on his trunk without skin rash. And about two minutes after the second intramuscular injection of TAT 300 U, the patient developed dizziness, blurred vision, and chest distress. He was placed in the supine horizontal position immediately. Physical examination showed a temperature of 37.5℃, a pulse rate of 74 beats/min, a respiratory rate of 20 breaths/min, a BP of 40/20 mmHg, consciousness, pale face, cold extremities, and muffled heart sound with an HR of 74 beats/min. Anaphylactic shock was diagnosed. He was administered oxygen inhalation therapy immediately, followed by adrenalin, promethazine, anisodamine, dexamethasone, calcium gluconate, dextran 40, and sodium bicarbonate. His condition normalized five hours later.
    KEY WORDS
  • 病例报告
    Zhou Dan
    . 2008, 10(4): 0-0.
    A 7-year-old boy with childhood autism was treated with oral huperzine A 50 μg twice daily. About 30 minutes after the first administration of the drug, the boy presented with collapsing to the ground, convulsion of the extremities, and upward deviation of the eyes. The symptoms lasted for about 1 minute, followed by lethargy. Epileptiform seizure was diagnosed. He quickly regained consciousness after treatment with fluid replacement, atropine, and furosemide; his convulsion did not reappear. Afterwards, the patient did not use the medication again. During 10 months of followup, his convulsion did not occur.
  • 病例报告
    . 2006, 8(5): 375-375.
  • 病例报告
    Zhang Guangping
    . 2007, 9(3): 211-212.
    A 72-year-old woman with depressive disorder received clomipramine (maximal dose 75 mg/day) and paroxetine(maximal dose 70 mg/day) one after another in a period of 13 years. She developed a cough and itch of throat after treatment of these drugs. And the cough disappeared on stopping the drugs, and reappeared on repeated exposure.
  • 病例报告
    Bian Hailin
    . 2010, 12(5): 362-2.
    A 83yearold woman received an IV infusion of levofloxacin 0.3 g in 5% glucose 250 mL once daily for biliary tract infections. The next day, the patient developed skin erythema and itching, followed by blisters with ulcerations, mainly on her chest, abdomen, buttocks and genital area. Nikolsky sign was positive. Laboratory examination results were as follows: WBC 8.43×109/L, N 0.74, β2microglobulin 12.80 mg/L,SCr 458 μmol/L, BUN 16.0 mmol/L, uric acid 404 μmol/L, and urine protein (+). She was diagnosed with toxic bullous epidermolysis type drug eruption with renal damage. Levofloxacin was discontinued immediately and replaced with an IV infusion of ceftazidine 1.0 g once daily, an IV infusion of methylprednisolone 80 mg twice daily, IM promethazine 12.5 mg and an IV infusion pantoprazole. In addition, external application of methyl violet and symptomatic treatment were given. Seven days after treatment initiation, her renal function partially recovered, and her skin lesions improved, but the ulceration on the buttocks remained unchanged. About one month later, she completely recovered.
  • 病例报告
    GAO Yang;YU Kai-jiang;WANG Hong-liang;LIU Yang
    . 2013, 15(1): 39-2.
    A 22-year-old female irregularly self-administered nimesulide 100 mg and ibuprofen 400 mg every time (dose frequency not stated) for 27 days for intermittent fever. On day 23 of taking these medicines, yellowish skin, sclera, and soybean-oil-color urine developed. Physical examination showed marked jaundiced skin in her whole body, upper abdominal tenderness, and her liver edge was palpated 3 cm below her xiphoid process. Laboratory tests revealed the following results: white blood cell count 12.3×109/L, prothrombin time 22 s, prothrombin activity 34%, fibrinogen 1.63 g/L, alanine aminotransferase 407 U/L, aspartate aminotransferase 558 U/L, total bilirubin 179.7 μmol/L, direct bilirubin 165.0 μmol/L, and ammonia 101 μmol/L. The patient was considered to be drug-induced liver failure. Nimesulide and ibuprofen were stopped and the patient was treated with anti-infective and liver-protective drugs, medications used to treat jaundice and decrease ammonia levels, fresh frozen plasma transfusions at a certain intervals, and plasma exchange. On day 25 after hospitalization, the patient′s liver function basically returned to normal.
  • 病例报告
    LI Dan-dan;XIE Qian;WANG Yue;ZHAO Rong-sheng
    . 2012, 14(5): 317-3.
    A 75-year-old woman received IV infusion of foscarnet sodium 3 g once daily combined with mecobalamin, vitamin B1, Xinhuang tablets (新癀片), and aciclovir ointment for herpes zoster. On day 4, she developed extremity and facial edema accompanied with nausea, anorexia and skin pruritus. On day 10, above-mentioned drugs were stopped except aciclovir ointment. On day 12, laboratory tests showed the following levels: serum creatinine 142 μmol/L, blood urea nitrogen 8.6 mmol/L, urine specific gravity 1010. Acute renal failure and acute interstitial nephritis was considered. The woman's fluid intake was restricted, and she received a low-salt, low-fat, and a high-protein diet. Five days later, her edema subsided and pruritus disappeared. Laboratory tests showed the following results: serum creatinine 86 μmol/L, blood urea nitrogen 7.4 mmol/L, phosphorus 0.9 mmol/L.
  • . 2017, 19(2): 156-158.
  • Wu Dandan, Zeng Ying, Lai Weihua
    Adverse Drug Reactions Journal. 2024, 26(8): 474-479. https://doi.org/10.3760/cma.j.cn114015‑20240126‑00064
    Objective To mine the risk signals of hypoxia?inducible factor prolyl hydrocylase inhibitor (HIF?PHI)?related adverse events (AEs) and provide reference for the safe use of the drugs in clinic practice. Methods AE reports of HIF-PHI drugs were collected from the US FDA Adverse Event Repor- ting System (FAERS) database during January 1, 2004 to September 30, 2023. AEs were classified and standardized according to the system organ class (SOC) and the preferred term (PT) in Medical Dictionary for Regulatory Activities 25.0. The AE risk signals of above mentioned 3 drugs were mined using reporting odds ratio (ROR) method. An AE with reports ≥3 and the lower limit of the 95% confidence interval (CI) of ROR >1 was defined as a risk signal. Descriptive analysis on the signals was performed. Results Only AE report data for roxadustat, daprodustat, and vacladustat were collected. A total of 78 AE reports related to roxadustat were collected, involving 12 PTs and 8 SOCs. The top 5 PTs in signal intensity were shunt occlusion, central hypothyroidism, gastrointestinal perforation, colon cancer, and hepatic function abnormal. Except for central hypothyroidism, the other 4 were not recorded in the labels. A total of 459 AE reports related to daprodustat were collected, involving 29 PTs and 13 SOCs. The top 5 PTs in signal intensity were gastrointestinal erosion, retinal haemorrhage, haemorrhoidal haemorrhage, abnormal feces and colon cancer. Retinal haemorrhage, abnormal feces and colon cancer were new adverse events not recorded in the labels. A total of 26 AE reports related to vadadustat were collected, involving 6 PTs and 4 SOCs. The top 5 PTs in signal intensity were drug eruption, face oedema, colon cancer, gastrointestinal haemorrhage, and dehydration, all of which were new adverse event not recorded in the labels. Conclusions The risk signals of roxadustat, daprodustat and vadadustat are mostly adverse events not recorded in the labels, such as shunt obstruction, gastrointestinal perforation, colon cancer, etc. When using the 3 drugs, clinicians should not only pay attention to the adverse reactions recorded in the labels, but also be alert to the adverse events not recorded in the labels.

  • Li Bing, Liang Li, Chen Yan, Guo Yuhang, Liu Xia, Fu Qiang, Guo Jinmin
    Adverse Drug Reactions Journal. 2024, 26(7): 417-422. https://doi.org/10.3760/cma.j.cn114015‑20231117‑00814
    Objective To mine the risk signals of adverse events of limaprost and provide reference for safe use of the drug. Methods US FDA Public Data Open Project (OpenFDA) platform wassearched, and the adverse event (AE) reports on limaprost from January 1, 2004 to October 1, 2023 werecollected. AEs were classified and standardized according to the system organ class (SOC) and preferredterms (PT) of Medical Dictionary for Regulatory Activities version 25.1. The reporting odds ratio (ROR) methodwas used to mine the risk signal of limaprost. An AE with reports ≥3, ROR ≥2 and the lower limit of the 95%confidence interval (CI)>1 was defined as a risk signal, which was analyzed descriptively. Results A totalof 1 618 AE reports with limaprost as the primary suspect drug were collected, 69 risk signals were identi‑fied, involving 17 SOCs. Of the 69 PTs, 10 were recorded in the drug instructions including hepatic functionabnormal, red blood cell count decreased, drug eruption, blood pressure decreased, liver disorder, plateletcount decreased, anaemia, haemoglobin decreased, pyrexia, and decreased appetite. The other 59 risksignals were not recorded in the drug instructions. The top 10 PTs in signal intensity were scleroderma,·417·药物不良反应杂志 2024 年7月第 26 卷第7期 ADRJ,July 2024, Vol. 26, No. 7tumour haemorrhage, brain natriuretic peptide increased, inappropriate antidiuretic hormone secretion,colitis microscopic, large intestine perforation, cardiac failure acute, depressive symptom, cardiac failurechronic, pulmonary alveolar haemorrhage. The risk signals with more than 10 reports were inappropriate antidiuretic hormone secretion, interstitial lung disease, renal impairment, cardiac failure, pneumonia, fall, etc.Conclusion In addition to the AEs recorded in the instructions, limaprost may also cause serious adversereactions such as tumour haemorrhage, brain natriuretic peptide increased, and inappropriate antidiuretichormone secretion, which are not recorded in the instructions and have a poor prognosis.
  • Xie Qing, Song Ziyang, Man Chunxia, Lu Cuilian, Zhai Suodi, Yan Suying, Liu Hua
    Adverse Drug Reactions Journal. 2024, 26(2): 70-75. https://doi.org/10.3760/cma.j.cn114015-20230925-00709
    Objective To explore the clinical characteristics of mirtazapine-related thrombocytopenia. Methods The diagnosis and treatment of a patient with mirtazapine-related thrombocytopenia who was admitted to the Aerospace Center Hospital was reported, and the main clinical data (gender, age, indications of mirtazapine use, dosage of mirtazapine, combined medication, platelet count before and after medication, time from application of mirtazapine to thrombocytopenia occurrence, clinical treatment and prognosis, etc.) of the case and similar cases collected by searching relevant databases (up to August 31, 2023) were analyzed by descriptive statistic method. Results A total of 9 patients were enrolled in the analysis, including 4 males and 5 females; the age ranged from 28 to 74 years, with a median age of 52 years. The indication of medication was depression in 8 patients, and 1 had no record. The daily dose of mirtazapine was 15-mg in 4 patients, 30-mg in 3 patients, and no record in 2 patients. Two patients were treated with mirtazapine alone, 6 patients were treated with mirtazapine combined with other drugs, and it was not recorded in 1 patient. The time from the application of mirtazapine to occurrence of thrombocytopenia in the 9 patients ranged from 2 to 28 days, with a median time of 8 days. The severity of thrombocytopenia was grade 1, 3, and 4 in 3, 3, and 2 patients, respectively; 1 patient had no relevant record. Of the 5 patients with severe thrombocytopenia, 3 developed bleeding, and 1 had skin ecchymosis. The results of drug-dependent antiplatelet antibody test in 2 patients were positive. Nine patients stopped mirtazapine treatment after diagnosis of thrombocytopenia, 6 patients did not receive special intervention, and 3 patients were given symptomatic treatments. After drug withdrawal for 2-43 days with the median time of 9 days, platelet counts returned to the reference range in 7 patients, platelet count increased in 1 patient, and platelet count was unknown but skin symptom was improved in 1 patient. Conclusions Mirtazapine-related thrombocytopenia usually occurs within 10 days of treatments, which can be improved after drug withdrawal. It is suggested to monitor the blood routine before and after the application of mirtazapine.
  • Yang Jun, Shi Yafei, Qi Shuya, Chen Wei, Li Guohui
    Adverse Drug Reactions Journal. 2021, 23(9): 468-473. https://doi.org/10.3760/cma.j.cn114015-20210209-00170
    Objective To compare the efficacy and safety between the generic pemetrexed produced by Sichuan Huiyu Pharmaceutical Co., LTD and the original pemetrexed produced by Eli Lilly Nederland B.V. in the treatment for patients with non-small cell lung cancer (NSCLC). Methods The subjects were patients who received generic and original pemetrexed from March 2019 to December 2019 in Cancer Hospital of Chinese Academy of Medical Sciences. Demographic characteristics (age, gender, past history, etc.), treatment-related information (NSCLC stage, treatment regimen, underlying diseases, etc.), occurrence of adverse events, and efficacy evaluation in patients were collected. Patients were divided into the generic group and the original group, and the general situation, clinical use of pemetrexed, and adverse events in patients in the 2 groups were compared. After propensity score matching for 7 variables such as gender, age, body weight, body surface area, Eastern Cooperative Oncology Group (ECOG) score, tumor stage, and standardized chemotherapy dose, the efficacy and safety in patients between the 2 groups after 2 cycles of treatment with generic and original pemetrexed were compared. Results A total of 182 patients were enrolled in the study, including 85 patients in the generic group and 97 patients in the original group. The differences in age, gender, ECOG score, body weight and body surface area, and underlying chronic diseases between the 2 groups were not statistically significant (all P>0.05). The patients with advanced stage Ⅲ and Ⅳ cancer in the generic group were significantly more than those in the original group [92%(78/85) vs. 79% (77/97), P=0.032]. The proportion of palliative chemotherapy and maintenance chemotherapy in the generic group was higher than that in the original group (P<0.001). The difference in median dosage between the generic group and the original group was statistically significant [900 (800, 1-000) mg/m2 vs. 800 (800, 900) mg/m2, P=0.019]. The difference in chemotherapy cycles between the 2 groups was statistically significant [5 (4, 10) vs. 4 (2, 4), P<0.001]. The overall incidence of adverse events and the incidences of bone marrow toxicity and liver toxicity in the generic group were higher than those in the original group (P=0.018, P=0.037, P=0.018). After propensity score matching, there were 38 patients in both groups, and the differences in the objective response rate, disease control rate and the incidence of adverse events between the 2 groups were not statistically significant [26% (10/38) vs. 32%(12/38), P=0.723; 89% (34/38) vs. 96% (36/38), P=0.674; 47%(18/38) vs. 24%(9/38), P=0.055]. Conclusion After propensity score matching, the difference in the efficacy and safety between the generic and the original pemetrexed was not significant.
  • He Yanxia, Xue Bing, Zhao Shumin
    . 2016, 18(2): 154.

    A 56-year-old male patient received oral warfarin 3 mg once daily for acute pulmonary embolism. Warfarin was added to 4.5 mg once daily based on international normalized ratio. On day 10 after administration of warfarin, the patient presented severe epigastric pain. Laboratory tests showed that serum amylase level was 360 U/L and 960 U/L on the next day. Abdominal ultrasound examination and CT showed a diffusely enlarged pancreas and fluid exudation around pancreas. The patient was diagnosed as acute pancreatitis. Warfarin was withdrawn and somatostatin and omeprazole were given. His abdominal pain was relieved obviously and serum amylase decreased to 130 U/L on the 10th day after warfarin withdrawal. Fifteen days after warfarin withdrawal, warfarin 3 mg once daily was given again because of varicose vein of lower limb. One week later, the patient′s abdominal pain appeared again and serum amylase elevated to 256 U/L. Warfarin was stopped again. Three days later, the patient′s condition improved. After one week, his serum amylase returned to 78 U/L.

  • Huang Wanyu
    . 2015, 17(6): 433-435.
    ObjectiveTo investigate the rational use of  antibacterial drugs after special rectification activity.MethodsDischarge records of 1 200 patients (8 to 12 per month in each department) in the Second People′s Hospital of Huaihua of Hunan Province Affiliated Hongjiang Hospital in 2012 (during the special rectification) and 2013 (after the special rectification) were selected randomly from 10 clinical departments, including internal medicine, surgery, gynecology, and paediatrics departments, etc. Retrospective analysis and comparison were done on number of types of antibacterial drugs, utilization rate, density of antibacterial drugs use, microbiological samples inspection rate before use of antibacterial drugs, the condition of antibacterial drug usage and antibacterial drug classification application in type Ⅰincision surgery patients.ResultsTotally 35 antibacterial drugs were used in 2012 while 36 in 2013. The usage rate of antibacterial drugs was 57.2%(686/1 200) in 2012 and 65.2% (782/1 200) in 2013(χ2=16.16, P<0.05). The antibacterial drugs use density was 39.4 DDDs/(100 patients·d) in 2012 and 46.6 DDDs/(100 patients·d) in 2013(t=5.00, P<0.05). Microbial samples′ detection rates of restricted antibacterial drugs before using were 46.7%(219/469) and 43.4%(254/585). The usage rates of antibacterial drugs in type I incision operation were 29.4% (40/136) and 45.3%(58/128)(χ2=7.14, P<0.05). The rates of rational use of preoperative drug delivery time were 52.5%(21/40) and 63.8% (37/58). The rates of rational use of duration of postoperative medication were 50.0%(20/40) and 53.4% (31/58). The usage rates of non-restricted antibacterial drugs were 29.3%(201/686) and 23.5% (184/782)(χ2=6.29, P<0.05). The usage rates of restricted drugs were 68.4%(469/686) and 74.8% (585/782)(χ2=7.49, P<0.05).ConclusionThe target reaching rate of antibacterial drugs utilization was reduced after special rectification, which warns that establishing long-term intervention and supervision mechanism is important.
  • 病例报告
    Wang Xinming;Wang Lei
    . 2014, 16(4): 249-2.
    A 3-year-old boy received an IV infusion of clindamycin 0.15 g twice daily for ulcerative stomatitis. Before giving clindamycin, his platelet count was 250×109/L. On day 2, the boy presented with red ecchymosis on left knee joint. On day 3, the boy developed gingival bleeding and skin scattered petechiae, his platelet count was 0 and activated partial thromboplastin time was 32 s. Clindamycin was stopped. IV infusions of methylprednisolone (30 mg, once daily) and human immunoglobulin (6 g, once daily), oral amino-polypeptide (0.2 g, thrice daily) were given. On day 4, his platelet count was 64×109/L, activated partial thromboplastin time was 26 s, prothrombin time was 12 s. After a week, the platelet count returned to 135×109/L and ecchymosis disappeared.
  • 论坛
    . 2014, 16(2): 72-2.
  • 病例报告
    Wu Min;Jiang Yin
    . 2007, 9(3): 210-211.
    A 56-year-old woman with liver dysfunction was administered with IV dexamethasone 10mg, and then IV iopromide 300 50ml before liver enhanced CT scan. Ten minutes later, she developed facial flushing, chest distress, tachypnea, and coma. Immediately, she was treated with oxygen, IV dexamethasone 10mg, IM proazamine 25mg. Her BP was 155/75mmHg. An electrocardiogram showed sinus tachycardia. Laboratory tests revealed the following levels: Glu 14.5mmol/L, WBC 13.74×109/L, and potassium 2.0 mmol/L. After treatment with fluid replacement, electrolyte supplement, and anti-allergy agent, the patient’s consciousness was restored.
  • 中毒救治
    Wu Na;Wang Dixin
    . 2008, 10(5): 0-0.

    A 5-month-old female infant with eczema was externally applied with Yisaoguang ointment which contains red lead (Pb3O4), ceruse and some other traditional Chinese mineral medicines. Ten days later, she developed listlessness, dysphoria, and mild anaemia. Laboratory tests revealed that her ALT, AST, and lead level were 61 U/L, 81 U/L, and 342.3 μg/L, respectively. Acute lead poisoning was suspected. Yisaoguang ointment was discontinued. After dimercaptosuccinate and symptomatic treatment, her symptoms were relieved. Subsequently, she was given methionine. Half a month later, her lead level and other laboratory values returned to normal range.

  • 调查研究
    Tan Zhiping;Wang Huichuan;Sha Furong
    . 2002, 4(6): 371-373.
    Objective:To investigate the association of hematuria with the intravenous drip of cefradine. Method: 18 cases with hematuria due to cefradine were received and analysed at the emergency department of our hospital from July 2000 to July 2001. Results: 1. The majority of patients with hematuria were young adults. 2. Hematuria occurred almost within an hour after intravenous drip of cefradine. 3. Hematuria could be related with dosage and purity of cefradine, and individual hypersensitivity. Conclusion: Much attention should be paid to cefradine for intravenous drip in order to reduce frequency of hematuria.
  • Liu Shunan;Li Hua;Tang Guorong
    Adverse Drug Reactions Journal. 2009, 11(4): 266-1.
    A 44yearold woman with vestibular neuritis received Ginkgo leaf injection 20 ml once daily, followed by an IV push of furosemide 10 mg once daily for improvement of circulation and reduction of intracranial pressure. On the third day, the patient developed generalized rash, dizziness, chest distress, palpitation, cold sweat, pallor, dyspnoea about 1 minute after an IV push of furosemide. Her blood pressure was 60/35 mm Hg. Furosemide was discontinued immediately, and oxygen inhalation, dexamethasone, adrenaline, and promethazine were given. Half an hour later, her breath was stable, rash subsided, and her blood pressure was 100/60 mm Hg. Ginkgo leaf injection was continued. The abovementioned symptoms did not recur.
  • Dong Yanhui
    Adverse Drug Reactions Journal. 2009, 11(4): 280-2.
    A 40yearold woman received an IV infusion of levofloxacin 0.2 g twice daily, 4 glycyrrhyza tablets, Xianzhuli solution 20 ml thrice daily, and 1 theophylline sustainedrelease 0.2 g tablet twice daily for acute attack of chronic bronchitis and obstructive emphysema. The next day, the patient developed abnormal behavior, visual hallucination, and auditory hallucination. Pulmonary encephalopathy and theophylline poisoning were excluded, and mental disorder was considered to be levofloxacinassociated. Levofloxacin was stopped and antipsychotics were given. Two days later, her symptoms disappeared.
  • 病例报告
    Zhang Xua;Zuo Changrub;Ma Yana
    . 2009, 11(2): 131-2.
    A 22yearold male patient received an IV infusion of compound glycyrrhizin 3 ampoules containing glycyrrhizin 120 mg dissolved in 250 ml of glucose 5%. About 5 minutes after infusion start, the patient presented with pale, dyspnea, chest distress, palpitation, cold sweat, and decreased blood pressure. An examination showed a temperature of 37℃, a heart rate of 162 beats/min, and a BP of 80/40 mm Hg. An ECG revealed ventricular extrasystole. His blood pressure decreased to 60/35 mm Hg. The infusion of compound glycyrrhizin was stopped immediately. Adrenalin, dexamethasone, dopamine, and amiodarone were given. His blood pressure and heart rate gradually returned to normal.
  • 病例报告
    Zhang Huifang
    . 2009, 11(2): 86-2.
    A 7yearold boy received an IV infusion of aspirinDLlysine 0.35 g dissolved in 100 ml of glucose 5% for pharyngodynia, cough, and fever. After infusion of about 35 ml, the boy presented with severe edema of eyelid and conjunctiva, slight congestion of palpebral conjunctiva, and mild blurred vision. The infusion was stopped immediately. Dexamethasone eye drops, cold wet compress, IM promethazine, IV calcium gluconate 10%, and IV dexamethasone were given. His symptoms completely disappeared 4 hours later.
  • 病例报告
    Yang Xiaoguang;Su Guoyun;Li Buyun
    . 2009, 11(2): 132-2.
    A 28dayold male neonate was treated with an IV infusion of cefmenoxime 0.1 g dissolved in 20 ml of sodium chloride 0.9% for infectious diarrhea. About 2 to 3 minutes after the start of the infusion, the neonate abruptly developed cyanosis, unconsciousness, and a heart rate of 80 beats/min; his femoral artery pulsation was absent. The infusion was stopped immediately. Oxygen inhalation therapy, closedchest cardiac massage, an IV push of 0.1% adrenaline 0.3 ml and dexamethasone 3 mg were given. About 20 seconds later, he experienced cardiopulmonary arrest. The patient was treated with endotracheal intubation, cardiopulmonary resuscitation and IV fluid supplement immediately. About 4 minutes after resuscitation, his respiration and heart beat were restored.
  • 中毒救治
    . 2002, 4(4): 241-243.
  • 调查研究
    Dai Hua;Ye Lika
    . 2002, 4(3): 150-153.
    Objective: To investigate the clinical medication in the hospital. Method: 338 cases out of 1283 inpatients in 2000 were randomized for the analysis of prescription patterns. Results: The problems of drug use were presented, such as improper drug combinations, drug incompatibility, irrational use of antibiotics and low level of drug monitoring. Conclusion: The clinical medication practice should be improved.
  • 调查研究
    Zhang Deliang
    . 2001, 3(3): 154-156.
    Objective: To determine the effect of risperidone and chlorpromazine on ECG.Methods: ECG of 252 subjects taking risperidone and that of 262 cases with chlorpromazine ingested were in comparison. Results: ECG abnormal rate of the former was 11.12%and the latter 34.74% , showing significantly different from each other. Conclusion: Risperidone is safer than chlorpromazine as for its damage to heart.
  • 综合报道
    . 2002, 4(2): 96-98.
    本文根据近10年来有关氟桂利嗪(西比灵)在临床使用中的不良反应个案报道,从神经系统、内分泌功能紊乱、过敏反应以及其它不良反应等4个方面进行了综合报道,以供临床参考。
  • 病例报告
    . 2005, 7(2): 130-131.
    An 82-year-old man was presented with dizziness for 30 years and progressive severity of nausea for one month. He was diagnosed as hypertension. He stopped taking antihypertensive drugs one year before the present hospitalization. The man was given zolpidem 10mg, once per night by mouth due to insomnia. 20 minutes after the second administration, the patient developed abnormal behavior and incorrect response. Physical examination showed inabilities of orientation, calculation and memory, mild stiff neck and positive Hoffmann sign. The man had no family history of mental disorders in the past. The above symptoms did not recur after withdrawal of zolpidem. It seems reasonable to link his symptoms to zolpidem treatment.
  • Liu Xiao;Liang Yan;Sun Peihong
    Adverse Drug Reactions Journal. 2009, 11(4): 293-2.
    A 38yearold woman was hospitalized with erythroderma and acute renal failure. On admission , the laboratory testing revealed a WBC count of 25.03×109/L, a RBC count of 4.26×1012/L, Hb 130 g/L, and a platelet count of 279×109/L. On day 7 of hospitalization,the patient received an IV infusion of linezolid 600mg twice daily for control of infections. On day 17, linezolid was discontinued and changed to an IV infusion of teicoplanin 400 mg once every 48 hours. On day 19, her platet count was 25×109/L. On day 20, teicoplanin was stopped and switched to an IV infusion of linezolid 600mg twice daily. Her platelet count was 37×109/L. On day 22, linezolid was discontinued and changed to an IV infusion of teicoplain 400 mg, and fresh plasma 200 ml and platelet 200ml were transfursed, respectively. On day 35 of hospitalization, her plateled count was 101×109/L.
  • 滥用误用
    Ren Aimin;Shen Shufeng;Zhang Junxia
    . 2008, 10(2): 128-1.

    A 46yearold man with ascites and abdominal cavity infection received IV Ruipuxin (cefoperazone/sulbactam)3 g without skin testing. One minute later, the patient developed a flushing in face and neck, generalized pruritus, numbness of the lips and tongue, and dyspnea. An examination revealed the following values: SPO2 0.98, BP 90/60 mmHg, and P 110 beats/min. Laryngoscopy showed laryngeal edema. Oxygen therapy and symptomatic treatment were given. One hour later, his symptoms resolved. The patient had experienced generalized prupritus after injection of Linglanxin (cefoperazone/sulbactam) a half month before.

  • 实验论著
    Hu Zhonghui;Wu Chunqi;Wang Quanjun;Wang Qingxiu;Luo Yongwei;Yang Baohua;Lu Shujie;Liao Mingyang
    . 2010, 12(1): 10-7.
    Objective: To study the toxic effects of two kinds of Lianbizhi injections on rats in order to provide experimental evidence for the causes of adverse reactions. Methods:Two kinds of Lianbizhi injections were used in this experiment as follows: Lianbizhi A containing andrographolide sodium bisulfis 98.7% and other related substance 1.3%, Lianbizhi B containing andrographolide sodium Bisulfis 49.1% and other related substance 50.9%. Seventy SPF male SD rats were randomly divided into 7 groups: the low-dose (400 mg/kg), moderatedose (800 mg/kg), and highdose (1 600mg/kg) Lianbizhi A groups, the lowdose (50 mg/kg), moderatedose (100 mg/kg), and highdose (200mg/kg) Lianbizhi B groups, and the empty control group (normal saline). Each group comprised 10 rats. All rats received respectively a single intravenous injection of Lianbizhi 10 mL/kg via caudal vein. The presentation of rats was observed within 3 hours after drug administration. The rats’urine was collected within 0~6, 7~12, 13~18 and 19~24 hours after drug administration. The levels and values of acetone bodies, occult blood, BUN, creatinine (Crea), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), N-acetyl-β-D-glucosaminidase (NAG) , and β2 microglobulin (β2-MG) were measured. The blood was collected from rat’s hearts, and the biochemical indexes were measured. Finally, the rats were sacrificed. Their organs were weighed, organ coefficient was calculated, and histopathological changes in the kidney were observed. Results: Two rats in the highdose Lianbizhi B group developed convulsion and erect hair, and they recovered 30 minutes later. No abnormal manifestation was found in rats in other groups. The number of rats having positive ketones in urine[≥(+2)] in high-, moderate-, and low-dose Lianbizhi A groups and highdose Lianbizhi B group was more than that in the control group. The number of rats having positive occult blood in urine[≥(+2)] in the high-, moderate-dose Lianbizhi A groups and high-, moderate-, and low-dose Lianbizhi B groups was more than that in the control group. The BUN levels in the highdose Lianbizhi A group were (319±108) mmol/L before drug administration and increased to (488±139) mmol/L within 7~12 hours after drug administration. The difference was statistically significant (P<0.05). The Crea levels in the high-, moderate-, and low-dose Lianbizhi A groups as well as high- and moderate-dose Lianbizhi B groups were respectively (3 338±1534),(3502±1457),(3428±1 729),(3 305±922),and (3 480±870) mol/L before drug ministration and increased respectively to (6 137±1 544), (5 847±1 319), (5 630±1 622), (5 613±1 968), and (5 218±1 496) mol/L within 7~12 hours after drug administration. The differences were statistically significant (all P<0.05). In addition, the Crea levels in high and moderatedose Lianbizhi A groups were markedly higher than that [(4 326±576) mol/L] in the control group (P<0.05). The increase in Crea levels was related to the dose of andrographolide sodium bisulfis(r=0.790 9). The ALP level in the high-dose Lianbizhi A group was (152±61) U/L within 7~12 hours after drug administration, which was higher than that [(99±37)U/L] in the control group. The ALP level in the high-dose Lianbizhi B group was (143±42)U/L within 7~12 hours after drug administration, which was higher than that [(94±42)U/L] before drug administration and that in the control group. The differences were statistically significant (all P<0.05). The LDH levels in the high, moderate, and lowdose Lianbizhi A groups as well as high-and moderate-dose Lianbizhi B groups were respectively (19±7), (18±11), (18±8), (17±5), and (17±10)U/L before drug administration, and then increased respectively to (88±56), (80±27), (50±17), (57±16), and (28±6)U/L within 0~6 hours after drug administration. The LDH levels in the high-, moderate-, and low-dose Lianbizhi A groups as well as highdose Lianbizhi B groups increased respectively to (44±21), (36±17), (34±13), and (31±7)U/L within 7~12 hours after drug administration. The differences were statistically significant (all P<0.05). In addition, the LDH levels in the high-, moderate-, and low-dose Lianbizhi A groups as well as high and moderatedose Lianbizhi B groups were higher than that [(18±10)U/L] at the same time periods in the control group, the LDH levels in the high-, moderate-, and low-dose Lianbizhi A groups as well as high-dose Lianbizhi B groups were higher than that [(23±7)U/L] at the same time periods in the control group. The differences were statistically significant (all P<005). The increase in LDH levels was related to the dose of andrographolide sodium bisulfis(r=0.899 0). The NAG levels in the high- and moderate-dose Lianbizhi A groups were respectively (0.30±0.04) and (0.31±0.04) U/L within 0~6 hours after drug administration; the NAG levels in the high-, moderate-, and low-dose Lianbizhi A groups were respectively (0.45±0.07), (0.40±0.18), and (0.37±0.14) U/L within 7~12 hours after drug administration; the NAG levels in the high-, moderate-, and low-dose Lianbizhi A groups as well as high-, moderate-, and low-dose Lianbizhi B groups were respectively (0.35±0.09), (0.31±0.06), (0.39±0.18), (0.60±0.09), (0.57±0.06), and (0.33±0.08)U/L within 13~18 hours after drug administration; the NAG levels in the moderate-and low-dose Lianbizhi A groups as well as high-, moderate-, and low-dose Lianbizhi B groups were respectively (0.32±0.03), (0.39±0.14), (0.32±0.07), (0.34±0.05), and (0.29±0.08)U/L within 19~24 hours after drug administration; which were higher than those [(0.26±0.05), (0.22±0.06), (0.24±0.07), and (0.24±0.06)U/L] in the control group. The differences were statistically significant (P<0.05). The β2MG levels in the high-dose Lianbizhi B group was (1.03±0.45) mg/L within 19~24 hours after drug administration, and it was (0.54±0.24)mg/L in the control group; the difference was statistically significant (P<0.05). The increase in NAG and β2-MG levels was associated with the amount of other related substance (r=0.874 9,r=0.981 9). There were no statistically significant differences in biochemical results in rats between the drugexposed groups and the control group. No marked changes in the appearance of rat’s organs, histopathology, and organ coefficient were found. Conclusion: The potential nephrotoxic effects of Lianbizhi injection on rats is related to its purity and dosage; high amount of other related substance and high dosage of the drug could increase renal damage.
  • 调查研究
    Yang Jingsong;Guo Limin;Xiao Kewu;Ai Xiong
    . 2001, 3(2): 83-86.
    Objective: To review the cases with DIUR in recent years.Methods: Chinese Pharmaceutical Abstract, Chinese Biomedical Abstract and CMSS Database of 1988 - 1999 were retrieved with an analysis of 309 DIUR cases.Results: On the list of DIUR high frequency analgetics ranked first (32.4%) followed by cardiovascular drugs (16.8%) and anti - infectives (11.7%) . Morphine and nifedipine were among the top drugs for urinary retention, leading to 79 and 30 cases respectively. In addition, sex, age, the way of drug administration and drug dose were the considerable factors, too.Conclusion: Rational use of drugs is suggested in order to reduce DIUR.
  • 国外文献题录
    . 2002, 4(1): 58-59.
  • 病例报告
    Xu Lanying
    . 2007, 9(4): 281-282.
    A 65-year-old man started receiving antituberculous treatment with isoniazide 0.3 g/d,rifampin 0.45 g/d,pyramide 0.5 g twice daily,and ethambutol 0.75 g/d after the operation of lymphoid tuberculosis.After 18 days of treatment,he developed chilly,hypodynamia,cough,and chest distress.He was treated with paracetamol and amoxicillin.The next day,his cough was aggravated and followed a fever(T 38 ℃),dyspnea,inability to lie flat,cyanosis of the lips,wheezing in the lungs.After symptomatic therapy,he relieved.After discontinuation of the antituberculous drugs,the asthma-like symptom disappeared.One week later,isoniazide was given to the patient at first,then,rifampin and pyramide were added respectively to his regimen every three days.The asthma-like symptom did not appear.But within several hours after addition of ethambutol,the asthma-like symptom reappeared.
  • Nan Ling;Liao Shumei
    Adverse Drug Reactions Journal. 2009, 11(5): 378-2.
    A 47-year-old man received an IV infusion of Danhong injection 40 ml in glucose and sodium chloride injection 250 ml once daily for infections after undergoing a achilles tendon repair on his left foot. On day 9 of therapy, 10 minutes after infusion start, the patient presented with a fever, and reddened, swelling, heated, and painful wound on his left lower limb. The symptoms subsided voluntarily without treatment. The abovementioned symptoms recurred after repeated infusion of Danhong injection, accompanied by bleeding from wound; and the amount of blood was 60 ml approximately. Management of wound was given. On day 12, the drug was discontinued and abovedescribed symptoms did not recur.
  • 中药不良反应
    . 2007, 9(1): 35-35.
  • 卷首语
    . 2013, 15(1): 1-1.
  • 病例报告
    . 2010, 12(3): 208-2.
    A 52yearold man with trauma received an IV infusion of monosialotetrahexosylganglioside 40 mg dissolved in 0.9% sodium chloride 250 mL once daily and IM gastrodine 200 mg twice daily for 14 days. Eight days later, the patient suddenly developed aching pain in limbs with weakness. Ten days later, he experienced worsened weakness in extremities and was unable to stand upright accompanied by polyhidrosis. Physical examinations showed decreased myodynamia and muscular tension in limbs and tendon reflexes were absent. Cerebrospinal fluid testing revealed albuminocytological dissociation. He received multiple treatments, including peripheral nerve nourishment, dehydration, and improving brain cell metabolism. Monosialotetrahexosylganglioside and gastrodine were not readministered. His conditions relieved after 15 days.
  • 病例报告
    Wang Yuping;Lin Hong
    . 2011, 13(1): 55-2.
    A 9monthold male infant received an IV infusion of ceftriaxone sodium for fever and cough, and then his temperature normalized. However, he developed facial pale, cry and noisy, and loss of appetite. Two days later, ceftriaxone sodium was replaced with IM penicillin, and the infant experienced lowgrade fever again. A further two days later, routine blood tests revealed the following levels: Hb 67 g/L, RBC 2.95×1012/L, WBC 22.16×109/L with neutrophils 0.30,lymphocytes 0.60,monocytes 0.07,and abnormal lymphocytes 0.03. He was administered an IV infusion of ceftriaxone sodium 0.9 g dissolved in 100 ml of 10% glucose, followed by intravenous ambroxol 15 mg via Murphy’s dropper. After receiving the infusion about 70 ml, the baby suddenly presented with facial pale, cry and noisy, brownish red urine, short of breath. Laboratory testing showed the following values: Hb 27 g/L, RBC 1.75×1012/L with reticulocytes 0.045, Coomb’s C31∶4, urine occult blood (+++), and urinary RBC 2-8 cells per high power field. Ceftriaxone sodium was stopped immediately. Meanwhile he received RBC transfusions and methylprednisolone pulse therapy. On day 6, routine blood tests showed a Hb level of 111 g/L and a RBC count of 3.83×1012/L. His condition improved.
  • 安全用药
    Song Haiqing
    . 2011, 13(4): 223-5.

    Statins are broadly used in the prevention of coronary heart disease and ischemic stroke. However, several studies indicate that statins may increase the risk of hemorrhagic stroke. The mechanism might be associated with cholesterol level, microbleed, and pharmacological action of statins. Manifestation of statins-induced hemorrhagic stroke is intracerebral hemorrhage which includes lobar hemorrhage and deep hemorrhage. A previous history of drug use is an important basis for a causal relationship assessment. Treatment measures include drug discontinuation, reducing intracranial pressure, control of blood pressure, and symptomatic treatment.

  • 综述
    Zhang Yunjian;Wang Xiaofang
    . 2014, 16(1): 30-5.

    New oral anticoagulants include direct thrombin inhibitor and factor Xa inhibitors. The direct thrombin inhibitor, dabigatran etexilate, and the factor Xa inhibitor, rivaroxaban and apixaban, have been approved in China; another oral agent, factor Xa inhibitor, betrixaban is being evaluated in a phase Ⅲ clinical trial; meanwhile the direct factor Xa inhibitor, edoxaban has also been approved in Japan. Compared with warfarin, dabigatran etexilate was superior in reducing the risk of intracerebral hemorrage, but it may be associated with increase of major or clinically significant minor bleeding in patients with acute coronary syndromes and risk of acute myocardial infarctionor acute coronary events. Rivaroxaban has been found to be superior to warfarin for stroke prevention in nonvalvular atrial fibrillation with significant reduction in the risk of intracerebral hemorrage,superior to enoxaparin in prophylaxis of venous thromboembolism in orthopedic surgery with similar major bleeding risk. Compared with warfarin, apixaban was superior in reducing the risk of stroke, systemic embolism or death and was associated with less intracerebral hemorrage and a similar or lower rate of major bleeding. The safety of apixaban was associated with its dose. Efficacy and safety of edoxaban were superior to warfarin in atrial fibrillation with the adverse drug reactions of bleeding. Betrixaban was as effective as enoxaparinin preventing venous thromboembolism in knee replacement patients, but had a lower risk of bleeding.

  • 论著
    Kang Jianbang;Tian Zhihong;LI Xiaoxia;Zhang Runmei;Duan Jinju;Zhang Ruiqin
    . 2014, 16(3): 147-6.
    ObjectiveTo understand the species and susceptibility of pathogens isolated from patients hospitalized in Departments of Internal Medicine and Surgery, and provide scientific basis for reasonable application of antibacterials and prevention and control of drug-resistant bacteria.MethodsThe pathogen isolation and drug sensitive test reports were collected from inpatients in Departments of Internal Medicine and Surgery in Second Hospital of Shanxi Medical University in 2012. The specimens included urine, blood, secretions, sputum, feces, throat swabs, cerebrospinal fluid, and so on. The original data were analyzed by WHONET 5.5 and SPSS 16.0 software and the distribution and susceptibility of pathogens isolated from patients hospitalized in Departments of Internal Medicine and Surgery were compared.ResultsA total of 4 268 strains of bacteria were isolated from 4 092 patients. Of them, 2 257 strains were isolated from 2 182 patients in the Department of Internal Medicine and 2 011 were isolated from 1 910 patients in the Department of Surgery. The top 5 bacteria in Department of Internal Medicine were Escherichia coli, Klebsiellapneumonia, Pseudomonas aeruginosa, Coagulase-positive Staphylococcus aureus, and Aerobacter cloacae. The top 5 bacteria in Department of Surgery were Escherichia coli, Pseudomonas aeruginosa, Klebsiellapneumonia, Acinetobacter baumannii,and Aerobacter cloacae. The antimicrobial susceptibility of some pathogens isolated from patients in Department of Internal Medicine were higher than that in Department of Surgery, they were as follows: Escherichia coli vs. cefoperazone/sulbactam, cefepime, ceftazidime, ceftriaxone, amd cefuroxime nitrofurantoin[62.7%(271/432) vs. 580%(202/348), 65.5%(283/432) vs. 55.5%(193/348), 63.8%(275/431) vs. 53.3%(185/347), 41.8%(180/431) vs. 34.4%(120/349), 34.0%(146/430) vs. 26.6%(93/349)]; Enterobacter cloacae vs. cefepime[94.4%(151/160) vs. 83.3%(140/168)]; Pseudomonas aeruginosa vs. amikacin [92.2%(190/206) vs. 86.1%(230/267)]; Acinetobacter baumannii vs. imipenem, meropenem, cefoperazone/sulbactam, ciprofloxacin, and minocycline [30.1%(31/103) vs. 19.0%(41/216), 29.7(30/101) vs. 17.5%(38/217), 19.4%(20/103) vs. 10.8%(23/213), 19.2%(19/99) vs. 9.8%(20/204), 23.2%(22/95) vs. 11.1%(22/198)]. The antimicrobial susceptibility of some pathogens isolated from patients in Department of Internal Medicine were lower than that in Department of Surgery, they were as follows: Staphylococcus aureus vs. trimethoprim/sulfamethoxazole, gentamicin, clindamycin [54.8% (40/73) vs. 78.9%(71/90), 50.0%(37/74) vs. 71.3%(62/87), 28.8%(21/73) vs. 46.6%(41/88)]; Klebsiella pneumoniae vs. levofloxacin [77.3%(269/348) vs. 90.5%(239/264)], Pseudomonas aeruginosa vs. tobramycin [81.8%(148/181) vs. 88.7%(235/265)]. The differences above mentioned were statistically significant (all P< 0.05). ConclusionsThe species of bacteria isolated from patients in Department of Internal Medicine and Surgery are different and the susceptibility of the same kind of bacteria to the same kind of antibacterial agent is also different. Clinician should use antibacterials rationally according to the results of drug sensitivity tests.
  • He Jianhua, Yi Jin
    . 2015, 17(6): 467-468.
    A 66-year-old female patient, who was treated with atorvastatin calcium 20 mg once daily 7 years after coronary stent implantation, received sertraline for her depression. The initial dose of sertraline was 25 mg once daily and increased gradually to 150 mg once daily. Her depressive symptoms were improved obviously. Fifty-two days after beginning of sertraline treatment, the patient felt very weak and fatigued. Laboratory examination showed the following results: alanine aminotransferase (ALT) 1 170 U/L, aspartate aminotransferase (AST) 805 U/L, gamma-glutamyl transpeptidase (γ-GT) 97 U/L, total bilirubin 9.6 μmol/L,direct bilirubin 3.1 μmol/L. Drug-induced liver injury  was diagnosed. Sertraline and atorva-statin calcium were stopped and liver-protective treatments were given. Her liver function was improved. Two weeks after drug withdrawal, laboratory test showed ALT 98 U/L, AST 47 U/L, γ-GT 101 U/L and ALT12 U/L, AST 17 U/L, γ-GT 12 U/L 3 months later.
  • Adverse Drug Reactions Journal. 2022, 24(10): 559-560. https://doi.org/10.3760/cma.j.cn114015-20221014-00950
  • Fan Junyu, Jiang Ting, He Dongyi
    Adverse Drug Reactions Journal. 2023, 25(1): 6-10. https://doi.org/10.3760/cma.j.cn114015-20211227-01303

    The biological disease-modifying antirheumatic drugs (DMARD) effectively prevented the progression of rheumatic diseases, improved the prognosis of patients, and promoted the innovation of the treatment pattern of rheumatic diseases. However, these drugs also have potential risks of inducing infection, malignant tumors, and immunogenicity of drugs, which should be paid attention to. At present, there are few relevant researches in China. This article introduces the research status of the above potential risks of biological DMARD in recent years, and puts forward some suggestions, hoping to contribute to the domestic related research and clinical safe drug use.

  • Liang Xiaomeng
    Adverse Drug Reactions Journal. 2022, 24(7): 382-384. https://doi.org/10.3760/cma.j.cn114015-20211217-01272
    A 3-year-old male patient underwent adenoidectomy under general anesthesia due to adenoidal hypertrophy and was given penehyclidine hydrochloride injection by intravenous injection to inhibit gland secretion; anesthesia induction with propofol, succinylcholine chloride, and naborphine injection were given by intravenous injection; sevoflurane was used for anesthesia maintenance. About 7 hours after the operation, the patient developed dark urine and lower limbs pain. Laboratory tests showed alanine aminotransferase (ALT) 256-U/L, aspartate aminotransferase (AST) 1-706-U/L, creatine kinase (CK)>16-000-U/L, CK-MB>1-000-U/L, myoglobin (MYO) 417-μg/L, and urine occult blood (+). Symptomatic treatments such as rehydration, alkalization of urine, and protection of myocardium were given. On the 1st day after the surgery, the urine color in the boy returned to normal and myalgia disappeared; on the 3rd day, MYO was 42-μg/L; on the 7th day, laboratory tests showed ALT 126-U/L, AST 41 U/L, CK 395-U/L, and CK-MB 23-U/L. One month later, the cardiac enzyme, liver and kidney functions in the child were all within the normal range. According to literature review, penehyclidine hydrochloride injection, propofol, naborphine injection, and sevoflurane are less likely to cause rhabdomyolysis, and it is considered that the rhabdomyolysis in the boy was more likely to be related to succinylcholine chloride.
  • Liu Jinchun, Tong Rui, Sheng Xiangling, Fang Qijun, Wu Weihua
    Adverse Drug Reactions Journal. 2024, 26(11): 665-671. https://doi.org/10.3760/cma.j.cn114015-20240511-00333
    Objective To analyze the occurrence and clinical features of liver injury induced by dandelion, a food-medicine homologous traditional Chinese medicine. Methods The patients with liver injury caused by taking dandelion, who were admitted to the Department of Infectious Diseases, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School from January 1, 2017 to December 31, 2023, were enrolled in this study. The electronic medical records of the patients were retrieved, and the patients′ general information, using of dandelion, combined medication, clinical manifestations, and liver biochemical test results were recorded. The causal relationship between dandelion and the liver injury were evaluated, and the clinical manifestations, classification, severity, treatment and prognosis of liver injury were analyzed. Results A total of 13 patients were enrolled in the study, including 8 females and 5 males. The age ranged from 29 to 78 years. Nine patients took dandelion by themselves, and 4 accor- ding to the doctor′s advice. The administration methods included dandelion root tea drink, whole herb tea drink, and powder drink mixed in water. Most patients′ liver injury occurred within 90 days after taking dandelion. The main clinical manifestations were yellowish staining of skin and sclera, dark urine, abdominal distension, abdominal pain, loss of appetite, etc. The laboratory tests showed that serum aminotransferase and bilirubin increased in 13 patients, alkaline phosphatase increased in 12 patients, and plasma ammonia increased in 5 patients. The causality evaluation results showed "probable related" in 8 cases and "highly probable related" in 5 cases. The clinical classification showed that 11 patients were of hepatocellular type and 2 of mixed type. The severity was mainly grade 2 (8 of 13 patients). Two patients with grade 3 and 2 patients with grade 4 developed liver failure. After symptomatic treatments, 11 patients′ liver function returned to normal or were improved; 2 patients′ condition progressed, of which 1 patient survived after liver transplantation and 1 patient died. Conclusions Dandelion can cause liver injury, mostly occurring within 90 days after administration, with moderate severity. After stopping dandelion and giving symptomatic treatments, most patients have a good prognosis, but there is a risk of liver failure and death.
  • Jiao Xiaohong, Yu Ming, Tang Gairu, Li Xunchang
    . 2017, 19(4): 304.
    A 54-year-old male patient received a long-term use of nifedipine (30 mg/d) due to hypertension of grade 3 (very high risk). In the 9th year of treatment, the patient developed purple in the face, dark purple areas and swollen in his lower limbs skin, and half a year later, the symptoms gradually aggravated, abdominal distension, chest tightness, shortness of breath, and generalized edema appeared. Abdominal ultrasound examination showed a large volume of peritoneal effusion in his abdominal cavity. Nifedipine was stopped, compound reserpine table 2 tablets thrice daily, captopril 25 mg thrice daily, and symptomatic and supportive treatments were given. After 11 days of treatments, the patient′s  abdominal distension, chest tightness, and shortness of breath were improved, peritoneal effusion was markedly reduced. Three months later, the edema subsided and peritoneal fluid disappeared. At more than 2 years of follow-up, the patient had been taking reserpine, captopril, and rosuvastatin, and edema and peritoneal fluid did not recur.
  • Cheng Jun,Zhang Guanjun,Han Yixuan
    Adverse Drug Reactions Journal. 2020, 22(10): 568-572. https://doi.org/10.3760/cma.j.cn114015-20191230-01099
    Objective To explore the clinical features of metronidazole-related acute pancreatitis. Methods Literature included in PubMed database up to September 2019 were searched and cases with a clear causal relationship between metronidazole and acute pancreatitis and relatively complete clinical data were collected. The following information of patients including nationality, gender, age, primary diseases, comorbidity, metronidazole medication, combined medication, occurrence of acute pancreatitis (time from medication to the onset of acute pancreatitis,symptoms, major laboratory tests results, pancreatic imaging findings, and etc.), and clinical treatments and outcomes was extracted. The collected data was analyzed by descriptive statistical method. Results A total of 12 patients were entered, including 8 from the Unite States, 4 from Greece, France, Ireland, and Turkey, respectively; 3 were males and 9 were females, aged from 22 to 63 years. The primary diseases in 5 patients were vaginitis and in 7 patients were Crohn disease, aspiration pneumonia, ulcerative colitis, pseudomembranous colitis, periodontal abscess, and ulce- rative colitis combined with Clostridium difficile colitis, and Clostridium difficile colitis, respectively; 1 of them were accompanied by history of peptic ulcer. A total of 24 times of metronidazole-related acute pancreatitis occurred in 12 patients (1, 2, 3, and 4 times occurred in 4, 5, 2, and 1 patients, respectively); 23 of them occurred in oral medication and 1 in intravenous medication; 16 cases occurred when metronidazole was used alone and 8 when metronidazole was in combination with other drugs. Time from the first application of metronidazole to the onset of acute pancreatitis was (3.9±2.8) days in 12 patients, time from reapplying metronidazole to recurrence of acute pancreatitis in 8 patients was (3.0±2.5) days, and the range of occurrence time both were 12-hours to 8 days after medication. The clinical symptoms, laboratory tests, and imaging findings of metronidazole-related acute pancreatitis were similar to those caused by other drugs. All the 24 times of acute pancreatitis had clinical symptoms, including 24 times of abdominal pain, 21 times of nausea, and 20 times of vomiting. Metronidazole was discontinued after the diagnosis of acute pancreatitis. Treatment measures were described in 17 times of acute pancreatitis, including symptomatic and supportive treatments such as fasting, analgesia, and antiemesis in 11 times. All patients recovered after 2-22 days of metronidazole withdrawal. Conclusions Metronidazole-related acute pancreatitis usually occurred within 8 days of medication and it mainly manifested as abdominal pain. Prodromal symptoms such as nausea and vomiting might occur in some patients. Early diagnosis and timely discontinuation of the drug might be helpful to a better prognosis in general.
  • 论著
    Chen Xin;Yang Li;Zhai Suodi
    . 2011, 13(2): 73-5.
    Objective: To systematically evaluate the risk of cardiovascular events with rosiglitazone and pioglitazone treatment in over 65yearold patients with type 2 diabetes mellitus. Methods: A search of Cochrane Library (1996 to 2010), PubMed (1966 to 2010), Embase (1966 to 2010), CJFD (1979 to 2010), CBM (1978 to 2010) and VIP (1989 to 2010) were conducted using keywords “rosiglitazone”,“pioglitazone”,“cardiovascular events”,“cardiovascular risk”,“elderly population”,“65 years old”,and “cohort study”. Retrospective cohort studies in comparison of cardiovascular events between rosiglitazone and pioglitazone in over 65yearold patients with type 2 diabetes mellitus were collected. According to the inclusion criteria, the literature was selected and assessed. The metaanalysis of data was conducted using RevMan 5.0 software. The relative risk ratio (RR) and 95% confidence interval (CI) of myocardial infarction, heart failure, and allcause mortality due to rosiglitazone or pioglitazone treatment in over 65yearold patients with type 2 diabetes mellitus were calculated. Results: Seventyfour related articles were obtained and, after detailed screening, three retrospective cohort studies from 2008 to 2010 were located, with a total of 295 668 patients (including 104 479 receiving rosiglitazone and 191 189 receiving pioglitazone). The metaanalysis revealed the following results: the incidence rates of myocardial infarction, heart failure and total mortality in the patients receiving rosiglitazone were higher than those in the patients receiving pioglitazone, their RR (95%CI) were 1.05(0.98-1.13,P=0.17),1.22(1.05-1.40,P=0.007) and 1.14(1.08-1.21,P<0.000 01),respectively. Conclusion: The risk of heart failure and allcause mortality is higher in rosiglitazone treatment than in pioglitazone treatment in over 65yearold patients with type 2 diabetes mellitus.
  • 论著
    Tian Jinghua;Xu Fei;Liu Yanan;Song Shujing;Hua Wenhao;Ma Xiuyun;Cai Haodong
    . 2011, 13(6): 341-7.

    Objective: To discuss the drug resistance occurring in chronic hepatitis B patients after an 8-year treatment with entecavir resistance. Methods: Sixty-three chronic hepatitis B patients were enrolled in the clinical trials (a randomised, double-blind, phase Ⅱ clinical trial of entecavir dosage and efficacy, a randomised, double-blind, phase Ⅲ clinical trial treating chronic hepatitis B patients with entecavir versus lamivudine, a phase Ⅲ clinical trial of entecavir for treating lamivudine-refractory patients with chronic hepatitis B, and a subsequent open-label clinical trial) from 2003 to March 2007, and then they continued therapy with continued follow-up. In the 8 years ending in March 2011, a cumulative incidence of entecavir resistance was calculated. Hepatitis B virus reverse transcriptase sequence mutations was detected and the causes of drug resistance were analysed. Results: Among 63 patients, 3 patients lost from follow-up after a 2-year treatment. One patient was transferred to another medical centre after 2 years and a half of treatment. In addition, of 59 patient, 16 received drug therapy for 4-6 years and 43 for 7-8 years. The duration of follow-up was 4-8 years and median follow-up duration was 7 years. Thirty patients developed clinical resistance to entecavir. Cumulative incidence of resistance was 20.5%. Nine patients with exhibiting drug resistance underwent the detection of HBV RT sequence mutations, 5 of them had lamivudine resistance-associated mutations of L180M and M204V and 1-2 mutation site of ETV resistance and the findings were compatible with ETV resistance profile. Three patients only had lamivudine resistance mutations. One patient had mutation sites of ETV resistance and ADE resistance mutations of A181T. Drug resistance development may be related to prior therapy of lamivudine, high viral load before treatment, poor virological response after a 6-month treatment, and poor medication compliance. Conclusion: Entecavir has a low resistance rate after long-term use of entecavir for treating chronic hepatitis B. Closely monitoring and improving medication compliance may decrease the development of resistance in patients who have an inadequate response to entecavir during the initial treatment period.

  • 病例报告
    Qu Caihonga;Su Xiangyangb
    . 2010, 12(5): 354-3.
    An 18-year-old woman received ciclosporin 100 mg 12-hourly, mycophenalate 200 mg 12-hourly, and methylprednisolone 8 mg 12-hourly following undergoing allergenic peripheral hematopoietic stem cell transplantation. The blood ciclosporin level was maintained at 177-283 ng/L. Two months later, oral voriconazole 200 mg 12-hourly was added to her regimen for treating pulmonary fungal infections. On day 8 of the drug therapy, the patient developed headache, dizziness, and blurred vision, he was then hospitalized with emergency. Symptomatic treatment was ineffective and her condition continued to worsen, and then symptoms of epileptiform seizure, such as trismus and convulsion of her limbs, occurred. Urgent testing revealed a blood ciclosporin level of 378 ng/L. Epileptiform seizure was considered to be related to elevated blood ciclosporin level. Ciclosporin and voriconazole were discontinued immediately. After 10 days of symptomatic and supportive treatment, the patient’s condition improved gradually, but the pulmonary fungal infections were not controlled. Vorconazol 200 mg 12-hourly was given orally again, and the ciclosporin dose was decreased to 75 mg 12-hourly. Her blood ciclosporin was maintained at approximately 250 ng/L. After 12 days of treatment in hospital, the patient was discharged with her medicines. At 1-month follow-up, her above-mentioned symptoms did not recur.
  • 病例报告
    LI Yu;CHEN Yu;LIU Hong-bo;FENG Xue-wei;ZHAO Li
    . 2012, 14(2): 107-3.
    A 55-year-old man with diabetic hyperosmolar coma and severe pneumonia received combination therapy with an IV infusion of imipenem and cilastatin sodium 1.0 g three times daily and levofloxacin 0.5 g once daily. An IV infusion of linezolid 0.6 g twice daily was added to his regimen due to poor efficacy, and then his temperature dropped gradually. On admission, his red blood cell count, hemoglobin level, and platelet count were respectively 4.4×1012/L, 141 g/L, and 251×109/L and, on the first day of linezolid therapy, were 3.7×1012/L, 122 g/L, 88×109/L, respectively. On the fifth day, his platelet count decreased to 34×109/L. Linezolid was discontinued immediately and changed to teicoplanin. Imipenem and cilastatin sodium and levofloxacin were continued and fresh blood plasma 200 ml was administered. On the sixth day after linezolid discontinuation, the platelet count returned to normal range (192×109/L). However, the red blood cell count and hemoglobin level fell progressively and, on the eighth day, reaching minimum values of 2.2×1012/L and 69 g/L, respectively. Then the two values increased gradually and, on day 27 after drug discontinuation, approached normal range.
  • ADR监测与防治
    . 2000, 2(4): 239-241.
  • 病例报告
    Cai Xuzhen;Huang Lina;Zheng Keyan
    . 2008, 10(6): 0-0.
    An 68-year-old woman was treated with allopurinol 0.1 g thrice daily for hyperuricemia. She received traditional Chinese medicines (injection) for 3 days during allopurinol treatment period. After 51 days of allopurinol treatment, the patient developed rash. Loratadine and traditional Chinese medicines were given, but her symptoms worsened. Three days before hospitalization, the patient's rash progressed to involve her entire body and dyspnea occurred. After admission, physical examination revealed ulceration of lips and oral mucous membrane, generalized red maculopapule, and superficial desquamation. Laboratory testing showed that BUN level increased from 7.10 mmol/L to 34.19 mmol/L, and SCr level increased from 131 μmol/L to 499 μmol/L. Allopurinol hypersensitivity syndrome was diagnosed. Allopurinol was discontinued. An infusion of dexamethasone 10 mg once daily was given. Finally, the patient died from renal failure and concurrent generalized infection.
  • 病例报告
    Wang Changlian; Lin Weiwei
    . 2009, 11(4): 292-2.
    A 53yearold man with upper respiratory infection received levamisole 50 mg once daily for 3 days for enhancing immunity. Fifteen days later, the patient developed dizziness and somnolence. Subsequently, his condition deteriorated and he had bradykinesia, slurred speech, difficulty walking, confusion, and convulsion; one month later, he went into a deep coma. His aEEG showed diffuse δ wave activities. NMR revealed the punctuate and patchy foci of T1 and T2 signal prolongations in the basal ganglia area and frontal and parietal lobes. Hypersignals were on FLAIR sequences and DWI . Levamisoleinduced demyelinating encephalopathy was diagnosed. Corticosteroids and symptomatic treatment were given. After one month, the patient improved, but he still had unstable walking.
  • 病例报告
    . 2005, 7(2): 105-105.
  • 病例报告
    . 2005, 7(2): 156-156.
  • 病例报告
    . 2005, 7(3): 216-218.
  • 中毒救治
    . 2002, 4(1): 32-32.
  • 监测交流
    . 2005, 7(6): 458-460.
  • 药物安全动态
    . 2006, 8(1): 67-72.
  • Chang Qinga;Shen Yanronga;Wang Lulub
    Adverse Drug Reactions Journal. 2009, 11(5): 365-1.
    A 37-year-old man with moyamoya was hospitalized for reexamination after undergoing an extracranialintracranial vascular anastomosis. After admission,an IV infusion of clindamycin 1.2 g dissolved in 250 ml of sodium chloride 0.9% was given for prevention of infections. The second day, the patient developed generalized itching, red papules covering his submaxilla and limbs, sporadic vesicles, and some vesicles fusing into lamellar pattern, as well as epidermolysis and exfoliation with exudation. His temperature was 37.6℃. Routine blood testing revealed following values : WBC count 14.5×109/L and 0.87 neutrophils. Dexamethasone, calcium gluconate, and promethazine were given immediately. Three days later, his rash subsided.
  • 病例报告
    Wang Xin;Zou Jianming;Wu Suning
    . 2009, 11(5): 366-1.
    A 25yearold woman with colpitis mycotica received oral allitrid 20 mg. Two hours later, the patient developed sporadic erythema in her upper limbs which progressed to involve her entire body. The erythma was symmetry and rednees with exduation at some sites. Her lesion site was calor and itching. Meanwhile she experienced facial edema, erosion of oral mucosa and upper lip, slight edema and hyperemia of urethral meatus and vaginal orifice, as well as arthralgia. Her temperature was 39.0℃. An IV infusion of dexamethasone and vitamin C were given immediately. Meanwhile she treated with oral methylprednisolone and drug for external application. Ten days later, her erythema gradually subsided.
  • 学术动态
    . 2010, 12(5): 371-3.
  • 病例报告
    . 2007, 9(1): 47-47.
  • 病例报告
    Lei Li;Luo Jizheng;Meng Junying;Song Yingxin;Bai Yun;Wang Lun;Wang Quan;Wu Liqun
    . 2007, 9(4): 277-278.
    Two old men with lung cancers died from interstitial 1ung disease during treatment with erlotinib.The first patient,an 84-year-old man with adenocarcinoma of lung and osseous metastasis was given erlotinib 150 mg once daily for osteodynia.At the first night,he developed a fever(T 38.3℃),cough,and expectoration in spite of osteodynia relieved.After anti-infective therapy with ceftriaxone sodium,his body temperature returned to normal.But the patient's condition deteriorated gradually.After 11 days of erlotinib therapy,he developed dyspnea.His partial pressure of oxygen in arterial blood was 67.5 mmHg after treatment with oxygen 5 L/min.A chest X-ray revealed diffused interstitial change in the lungs.Erlotinib was withdrawn.The patient died of respiratory failure in the next day.The second patient,a 69-year-old man with right lung squamous carcinoma received chemotherapy,radiotherapy,and symptomatic therapy.A CT scan revealed the focus slightly decreased in size,and the patient's condition was stable.After 2 days of receiving erlotinib 150 mg once daily,he developed skin rash on face and trunk.His rash recovered by local symptomatic treatment.After 29 days of administration of erlotinib,he developed a fever,aggravation of cough and short breath.His count of WBC was 10.2×109/L.The efficacy of anti-infective therapy was not apparent.Repeat CT scan showed diffused interstitial change in the 1ungs on day 35.Erlotinib was discontinued.The next day,the patient's condition aggravated suddenly.He presented with severe dyspnea.Arterial blood gas analysis revealed hypoxemia.On day 3 he died of respiratory failure.
  • ADR系列问答
    . 2007, 9(1): 74-74.
  • 论著
    Zhang Wenhui;Yilihamu·Kelimuaji;Nusulaiti·Aihemaiti;Du Yunnan;Ma Xiaojie
    . 2014, 16(4): 227-5.
    ObjectiveTo investigate the effects of glucose and lipid metabolism disorder induced by olanzapine on cognitive function in rats.MethodsForty healthy male SD rats of clean degree were divided into the olanzapine group and the control group using random-digital table, each group comprised 20 rats. The rats in the olanzapine group received intragastric administration of olanzapine 1.2 mg/kg once daily for 4 weeks for duplicating adiposity model. The rats in the control group received intragastric administration of same volume of 0.9% sodium chloride solution once daily for 4 weeks. The rats′ body weight in the 2 groups were measured every week during the intragastric administration. The levels of serum fasting blood-glucose, total cholesterol (TC), triacylglycerol (TG), high density lipoprotein cholesterol (HDL-C), and low density lipoprotein cholesterol (LDL-C) in rats in the 2 groups were measured after the intragastric administration. The Y maze test was carried on and the number of shocks which was the criterion of learning ability were recorded and compared between the 2 groups. The Morris water maze was carried on and the escape latency was recorded and compared between the 2 groups. The morphological changes in hippocampal CA1 area in the 2 groups were observed after the maze experiments.ResultsThe body weight on the second, third, and fourth weeks of intragastric administration in the olanzapine group was higher than those in the control group (all P<0.05). The body weight on the fourth week of intragastric administration in the olanzapine group was 20% more than that in the control group (P<0.05). The levels of serum fasting glucose, TC, TG, and LDL-C in the olanzapine group were obviously higher than those in the control group, the level of serum HDL-C was significantly lower than that in the control group ( all P<0.05 ) at the end of the four weeks of intragastric administration. The result of Y maze test showed the number of shocks in the olanzapine group was obviously more than that in the control group [(82.65±0.12) times vs. (50.25±0.02) times,P<0.05]. The result of Morris water maze test showed the escape latency in the olanzapine group was longer than that in the control group [(62.20±0.10) s vs. (23.54±0.12)s, P<0.05] . The morphological experiment showed the malalignment, deletion, and edema appeared in the hippocampal CA1 area neurons in the olanzapine group at the end of four weeks of intragastric administration.ConclusionOlanzapine can increase the levels of rats′ blood-glucose and blood lipid, and affect the cognitive function.
  • Hou Wenjing, Wen Aiping
    Adverse Drug Reactions Journal. 2024, 26(5): 257-260. https://doi.org/10.3760/cma.j.cn114015-20240402-00215
    Chronic kidney disease (CKD) has become a global public health problem. Slowing disease progression is vital in CKD management, and drug therapy is an important part of the treatment for CKD patients. However, the risk for adverse drug event is higher in patients with CKD due to impaired renal function, prolonged disease duration, presence of multimorbidity and polypharmacy. Therefore, it was recommended to promote medication safety in patients with CKD through the following 4 specific strategies: (1) carrying out more studies to improve evidence-based practice for medication in patients with CKD; (2) conducting dose adjustments according to glomerular filtration rate and continuous drug therapy monitoring to a dynamic management of the dose; (3) implementing multidisciplinary care; (4) utilizing appropriate information technology actively.
  • 病例报告
    Sun Hongyan;Cao Kai;Sun Min
    . 2014, 16(4): 244-2.
    A 61-year-old male patient with lumbar disc herniation received oral methocarbamol 0.5 g twice daily. On day 6 of treatment, the lumbago was alleviated and the patient stopped the drug without permissions. Six days later, he took the same dose of methocarbamol for worsened lumbago. On day 7 of treatment with methocarbamol again, the patient developed icteric skin, dark urine and anorexia. Six days later, the patient stopped the drug again due to apocleisis. Laboratory tests showed the following results: alanine aminotransferase (ALT) 2 369 U/L, aspartate aminotransferase (AST) 1 198 U/L, direct bilirubin (DBil) 87.1 μmol/L, indirect bilirubin (IBil) 75.4 μmol/L. Drug-induced liver injury was diagnosed. He received IV infusions of glutathione 1.8 g once daily and magnesium isoglycyrrhizinate 0.2 g once daily. Two days later, laboratory tests showed the following results: ALT 1 331 U/L, AST 503 U/L, DBil 73.9 μmol/L, IBil 68.9 μmol/L. Thirteen days later, repeat liver function tests showed the following levels: ALT 231 U/L, AST 72 U/L, DBil 34.5 μmol/L, IBil 45.0 μmol/L. His therapy was changed to oral glutathione 0.4 g thrice daily and diammonium glycyrrhizinate 0.15 g thrice daily. His jaundice subsided at follow up after one month, and liver function tests showed the following levels: ALT 19 U/L, AST 21 U/L, DBil 2.3 μmol/L, IBil 11.4 μmol/L.
  • 病例报告
    Chen Jin;Gao Jie
    . 2014, 16(6): 375-3.
    A 53-year-old man took ciclosporin, mycophenolate mofetil, and prednisone regularly for seven years and two months after kidney transplantion. And because of radical operation for colon cancer, ciclosporin was stopped and switched to oral sirolimus 2.0 mg once daily. After about half a month of drug use, the plasma concentration of sirolimus was 12.65 ng/ml. And then, the dosage of sirolimus was reduced to 1.5 mg once daily by the patient. After 4 days, the dosage of sirolimus was changed to 1.0 mg once daily according to the doctor′s advice. One week later, clarithromycin 0.25 g twice daily orally was added because of pustules on his lips. On day 4 of concomitant use of the four drugs, the plasma concentration of sirolimus was higher than 30 ng/ml. Clarithromycin was discontinued on the day and the other drug did not change. After one week, the plasma concentration of sirolimus reduced to 9.82 ng/ml.
  • 中药不良反应
    Tan Wenchao;Yuan Dongmin
    . 2007, 9(3): 219-219.
    A 77-year-old woman with coronary heart disease and unstable angina was administered with Kudiezi injection 40ml once daily. On day 3, after ten minutes of infusion, she developed shudder, cold limbs, palpitation, nausea, and vomiting. A physical examination showed the following values: T 37.3℃, P 95 times/min, BP150/100 mmHg. Immediately, Kudiezi injection was withdrawn and she was given symptomatic therapy. A half hour later, the patient occurred nausea and vomiting again. A re-examination revealed the values as follows: T 39.4℃, P 84 times/min, BP140/80 mmHg. Four hours after administration of IM bromisoval procaine 2 ml and symptomatic therapy, she recovered with a body temperature of 37.9℃, a pulse of 75 times/min, a BP of 95/60 mmHg. She felt the symptoms relieved obviously.
  • 病例报告
    Qin Xuewei;Zhang Bin
    . 2010, 12(1): 64-1.
    A 64yearold woman undergoing an operation for lumbar spinal canal stenosis under general anesthesia received an IV infusion of atropine 0.5 mg and dexamethasone 10 mg via Muphy's dropper before surgery. Twenty mintues later, she developed palpitation, dyspnea, and squeezing pain in the substernal area. Meanwhile, her heart rate was 181 beats/min and blood pressure was 275/115 mm Hg. An IV push of esmolol, urapidil, and lidocaine hydrochloride was given successively, then her vital signs became stable and the operation was completed uneventfully.
  • 实验论著
    Bai Shuyuan;Wang Peichang*;Li Yan;Zhang Lili;Min Rong;Zhang Hongyan;Wang Yuying;Shang Jing
    . 2010, 12(2): 96-4.
    Objective: To investigate the trend in development of resistance of Acinetobacter baumannii and Pseudomonas aeruginosa to 15 different kinds of commonly used antibacterial agents in clinical practice in order to provide a basis for appropriate selection of antibacterial agents. Methods:The strains of Acinetobacter baumannii and Pseudomonas aeruginosa were isolated from blood, urine, sputum, pus and other specimens from inpatients in Xuanwu Hospital of Capital Medical University during the period 20062009. The identification of bacteria and antimicrobial susceptibility testing were performed by a routine method and VITEK 32 automatic measurement system. The results were evaluated according to CLSI 2008. Results:Isolation rates of Acinetobacter baumannii during the period 20062009 were 8.7%(251/2 885), 7.6%(218/2 868), 7.6%(172/2 263)and 13.1%(396/3 023), respectively. The isolation rate in 2009 increased markedly. Isolation rates of Pseudomonas aeruginosa during the period 20062009 were 14.5%(417/2 885),13.3%(382/2 868),14.1%(319/2 263)and 10.7%(322/3 023), respectively. The isolation rate decreased year by year. Resistance rates of Acinetobacter baumannii to 12 different types of antibacterial agents during the period 20062009 increased: resistance rate of Acinetobacter baumannii to imipenem and meropenem were 10.4% and 11.2% in 2006 and increased to 56.3% and 57.1% in 2009, respectively. Resistance rate of Acinetobacter baumannii to cefepime and piperacillintazobactam were 22.7% and 20.3% in 2006 and increased to 64.1% and 52.5% in 2009, respectively . The resistance rate of Acinetobacter baumannii to cefoperazone-sulbactam was the lowest (26.8%) in the 15 antibacterial agents and that to other 14 antibacterial agents was higher than 50%. Resistance rates of Pseudomonas aeruginosa to piperacillintazobactam and cefepime were 22.8% and 18.6 % in 2006 and increased to 29.2% and 38.8% in 2009, respectively. Resistance rates of Pseudomonas aeruginosa to imipenem and levofloxacin were 42.4% and 45.8% in 2006, and decreased to 35.4% and 37.9% in 2009, respectively, and those to other 11 antibacterial agents were stable. The resistance rate of Pseudomonas aeruginosa to cefoperazonesulbactam in 2009 was the lowest (15.0%). Conclusion: Analysis of the resistance rate of Acinetobacter baumannii and Pseudomonas aeruginosa is beneficial to the appropriate choice of antibacterial agents and preventing transmission of drug-resistant strains.Ceroperazone-sulbactam may be considered the drug of choice in the treatment of the infections caused by the two bacteria.
  • 病例报告
    Wang Yuzhu;Chang Yan;Wang Qing;Lu Congzhe;Yu Xiaohong
    . 2010, 12(2): 136-2.
    Two male patients, aged 52 and 79 years, received SC nadroparin calcium 6 000 IU every 12 hours for cerebral infarction and unstable angina pectoris, respectively. Liver function tests in patient 1 showed an ALT level of 169 U/L on day 6; and laboratory examinations in patient 2 revealed the following values on day 3: ALT 246 U/L, γ-GT 521 U/L, TBil 28.5 μmol/L, DBil 8.9 μmol/L. Nadroparin calcium was stopped and an IV infusion of polyene phosphatidylcholine was given. Subsequently, their liver function improved gradually.
  • 病例报告
    . 2000, 2(1): 50-50.
  • 论著
    TANG Zhi-hui;WANG Bo;GUO Dai-hong;ZHU Man;CHEN Chao
    . 2012, 14(5): 273-4.
    Objective To analyze the clinical data of hospitalized patients due to adverse drug reactions (ADR) in endocrine ward in order to provide the basis for safe drug use in clinical practice. Methods The clinical data of discharged patients’medical records in Chinese PLA General Hospital endocrine ward from January 2011 to June 2012 were collected. The hospitalized patients due to ADR were diagnosed according to the clinical manifestations and the ADR evaluation criterion. The type of ADR, drugs associated with adverse reactions, duration of hospitalization, cost of hospitalization and outcome of patients were retrospectively analyzed. ResultsA total of 3187 patients’medical records were collected. Of them, 15 patients (0.47%) were hospitalized due to ADR. They comprised 7 males and 8 females with an average age of (59±16) years, an average duration of hospitalization of (13.5±9.7) days, and an average cost of (9182±4258) yuan. Of them, four patients (27%) were diagnosed with drug-related adverse reactions on admission, six (40%) were diagnosed with drug-related adverse reactions on discharging from hospital, and the other five patients (33%) were diagnosed with drug-related adverse reactions by analyzing the medical records. Six patients had drug or food allergic history. The type of ADR included hypoglycaemia, hypokalemia, renal tubule acidosis,liver enzyme elevations, electrolyte disturbances, and hypothyroidism. The symptoms were similar to those of the endocrine system diseases. Fifteen patients improved and discharged after drug withdrawal and symptomatic treatment. The drugs related to adverse reactions included hypoglycemic drugs, hypoglycemic Chinese patent medicine and health products, methimazole, and adefovir. ConclusionThe drugs that cause adverse reactions in this study are commonly used medications in the endocrine ward. The clinicians should closely monitor the signs and symptoms of adverse reactions when using above-mentioned drugs, and should be aware of the methods of diagnosis, differential diagnosis, and management.
  • 中药不良反应
    ZHANG Xiu-hong;JIANG Li-sha
    . 2013, 15(1): 54-2.

    A 53-year-old woman self-medicated with 4 Lingzhiyishou capsules thrice daily to improve physical strength and vitality. Two months later, the patient developed dark urine. About four months later, she presented with jaundiced skin and sclera, upper abdominal discomfort, accompanied by nausea, fatigue, and lassitude. Laboratory tests revealed the following levels: alanine aminotransferase (ALT) 1114 U/L, aspartate aminotransferase (AST) 611 U/L, γ-glutamyl transferase (γ-GT) 235 U/L, alkaline phosphatase (ALP) 158 U/L, total bilirubin (TBil) 104.5 μmol/L, direct bilirubin (DBil) 63.2 μmol/L, indirect bilirubin (IBil) 41.3 μmol/L, total bile acid (TBA) 165.3 μmol/L. She was diagnosed with drug-induced liver injury. Lingzhiyishou capsules were stopped and she was given reduced glutathione, magnesium isoglycyrrhizinate, and ademetionine 1, 4-butanedisulfonate. Two week later, repeat liver function tests showed the following levels: ALT 69 U /L, AST 35 U/L, γ-GT 100 U/L, ALP 137 U/L, TBil 30.1 μmol/L, DBil 14.4 μmol/L, IBil 15.7 μmol/L, TBA 70.2 μmol/L.

  • . 2013, 15(5): 244-4.
  • 不良事件
    . 2004, 6(5): 347-347.
  • 不良事件
    . 2004, 6(5): 345-345.
  • 综述
    Zhang Li;Chen Haiping
    . 2008, 10(5): 0-0.
    Objective: Peroxisome proliferatoractivated receptor gamma (PPAR-γ)agonist mainly includes thiazolidinediones and novel nonthiazolidinediones PPAR-γ agonist. The commonly used thiazolidinediones are troglitazone, pioglitazone, and rosiglitazone. One of the common adverse reactions to PPAR-γ agonist is edema, which may worsen or precipitate congestive heart failure (CHF). The incidence of edema is 3%~28.9%. PPAR-γ agonist combined with other oral antihyperglycemic agents or insulin can increase the incidence of edema. The mechanisms of edema induced by PPAR-γ agonist involve watersodium retention, blood vessel dilation and increased vascular permeability, particularly associated with the deregulation of renal salt and water transport proteins distribution over distal tubes and collecting ducts which plays an important role in development of watersodium retention. PPAR-γ agonistinduced edema is often mild, and it subsides gradually after drug discontinuation. PPAR-γ agonist should be avoided in patients with moderate to severe CHF [New York Heart Association (NYHA) class Ⅲ~Ⅳ], and should be used with caution in patients with mild CHF (NYHA classⅠ~Ⅱ). PPAR-γ agonists should be given as low dosage as possible. The dosage should be gradually increased, if necessary. PPAR-γ agonists combined with diuretics may be given. The patients' weight and edema should be closely monitored. Strategies for prevention and management of edema include the use of novel and selective PPAR-γ moderators, specific inhibitors of protein kinase C-β or epithelial sodium channel, and PPAR-γ antagonists.
  • 病例报告
    Zhao Yanmei;Wang Xuemei;Zhang Junxia;Jin Wanping
    . 2008, 10(2): 136-2.

    An 81yearold woman with pulmonary metastasis of liver cancer received oral sorafenib 400 mg twice daily. On week 4, the patient experienced a prickling on her hands, feet, and nipples accompanied with desquamation. On week 6, she presented with nausea, anorexia and an increase in number of stools. Despite a decrease in her sorafenib dosage to 400 mg once daily and symptomatic treatment, the symptoms still did not improve. On week 20, severe anorexia, marked nausea, diarrhea with 10~20 times watery stools daily and weight loss of 7 kg occurred in the patient. Sorafenib was discontinued. Two months later, her nausea resolved; her appetite improved; her daily number of stools was reduced to 2~3, and her weight loss did not occur again.

  • Wu Aihuia;Zhou Rongbina;Han Juqiangb;Zhang Yuanboa;He Yanga;Chen Dongmeia
    Adverse Drug Reactions Journal. 2009, 11(3): 222-2.

    A 23-year-old man with acute purulent tonsillitis received 1 aspirin 0.5 g effervescent tablet for a fever. About thirty minutes after administration, the patient developed facial swelling, mild skin flushing over his entire body, pruritus, chest distress, short of breath, dyspnea, and cyanosis. After admission, an examination revealed a BP of 70/40 mm Hg, a heart rate of 125 beats/min, a respiratory rate of 36 breaths/min. He had popular eruption of different sizes on his entire body and wheezing over both lungs. ECG showed sinus tachycardia. Oxygen inhalation, dexamethasone, promethazine, and fluid expansion were given immediately. Half an hour later, his symptoms improved gradually.

  • 个案分析
    . 2003, 5(1): 51-53.
  • 学术研讨
    . 2005, 7(4): 241-244.
    为了解儿童青少年使用5-羟色胺(5-HT)再摄取抑制剂(SSRIs)与有害事件的关联,对已公开发表的临床随机对照试验报告及流行病学资料进行分析。尽管有研究报告揭示SSRIs与日益增多的有害事件有关,但已知的临床研究结果并不能提供足够的证据,证明两者之间存在关联。对严重抑郁障碍,最佳治疗方案应为氟西汀与认知行为治疗相结合;SSRIs不应作为治疗轻、中度抑郁症的首选药物而应作为二线治疗药物。对SSRIs与有害事件的相关性有必要进一步做出及时评估,为其临床安全应用提供可靠依据。
  • 论著
    Liu Sheng;Liu Guoshu;Luo Leiming;Qin Xiuchuan;Zhang Minghua
    . 2005, 7(3): 171-174.
    Objective:To study the effects of Taizhian capsule on patients with primary hyperlipidemia accompanied by slightly elevated transaminase. Methods: 90 outpatient cases with primary hyperlipidemia accompanied by slightly elevated transaminase were chosen randomly in the PLA General Hospital, People Hospital of Peking University and the Third Hospital of Peking University, 30 cases each. All patients had 3 capsules orally each time and 3 times daily for 12 weeks. The multicentre and self-reference statistic study was adopted. A series of examinations were performed before and during the treatment, such as lipid profile and liver function. Meanwhile, the adverse reactions were recorded all the time. Results: 12 weeks after treatment, TC and TG decreased significantly(p<0.01); HDL-C increased while LDL-C decreased to a certain extent(p<0.05); levels of liver enzymes such as ALT and AST dropped markedly(p<0.01). No serious adverse reactions were discovered. Conclusion: Taizhian capsule had desirable effects on patients with primary hyperlipidemia accompanied by slightly elevated transaminase, in addition to good compliance and relative safety.
  • ADR护理
    . 2005, 7(1): 48-50.
    肝动脉化疗栓塞术后的主要并发症有发热、胃肠道反应、肝区疼痛、肝衰竭、呃逆等。我们对76例次肝动脉化疗栓塞术治疗原发性肝癌患者进行临床观察,对其并发症采用相应的护理,旨在提高护理水平和患者的生命质量。
  • 安全用药
    . 2005, 7(6): 427-429.
    二妙丸(散)和四妙丸均以燥湿清热为主,用于湿热病症。二妙丸(散)用于湿热证湿重于热的各种病症,而四妙丸则是以二妙为底,主要治疗湿热痿痹症等。在药理作用方面,由于二妙丸具有明显的免疫抑制作用,对于某些以变态反应为诱因的疾病疗效颇佳;而四妙丸中因加味的牛膝、薏苡仁能增强免疫功能,故有明显的免疫调节作用,不宜用于以变态反应为主要病因的疾病。
  • 病例报告
    Liu Ruining;Zhou Xin
    . 2009, 11(4): 289-2.
    A 76yearold man was hospitalized with coronary heart disease. An examination revealed jaundice and blood coagulation disorder. Congestive liver damage was considered. Three diammonium glycyrrhizinate 50 mg capsules thrice daily, fosinopril, torasemide, and potassium citrate were given. The next day, the patient developed diarrhea. Diammonium glycyrrhizinate was discontinued. Other medications were continued and dioctahedral smectite was given. His diarrhea resolved. His diarrhea reappeared after readmitnistration of diammonium glycyrrhizinate capsules and resolved after the drug discontinuation.
  • 中药不良反应
    Liu Chenyun;Liu Yuehong;Man Hui
    . 2008, 10(2): 149-1.

    A 34yearold man with necrosis of femoral head was administered with oral Diedashenggu granules 10 g once daily. After two months, he developed nausea, aversion to fats, and abnormal liver function. Half a month after drug withdrawal, the liver function returned to normal limits. The medication was continued. Three months later, the patient presented with dark urine and hypodynamia. Laboratory investigations revealed the following values: ALT 1 008 U/L, TBil 633 μmol/L, DBil 482 μmol/L, Blood ammonia 96 μmol/L, PTA 43.1%. Color ultrasound examination showed rough liver echo, splenomegaly, and ascites. Diedashenggu granules was discontinued, and he was given liverprotective treatment. Two months later, his symptoms resolved gradually and his liver function normalised.

  • 病例报告
    Li Jian;Zhao Shuqing
    . 2009, 11(2): 145-1.
    A 48yearold woman received 1 oxycodoneacetaminophen tablet (containing oxycodone hydrochloride 5 mg and acetaminophen 500 mg) for right lower leg trauma. One hour later, she experienced dizziness. The next day, the patient received 1 oxycodoneacetaminophen tablet again after breakfast. One hour later, she presented with vague pain in her temples, vertigo, nausea, and unstable walking. She was administered an IV infusion of ligustrazine and an IV infusion of Shuxuetong. Seven hours later, she improved. In the evening, the patient developed the same symptoms after the third administration of 1 oxycodoneacetaminophen tablet. Her symptoms relieved after administration of IM promethazine 25 mg. Oxycodoneacetaminophen tablets were discontinued, and her headache and vertigo did not recur.
  • 病例报告
    Zhang Yan;Deng Liqin
    . 2009, 11(2): 143-1.
    A 39yearold woman received oral ritodrine 10 mg every four hours for vaginal bleeding. After 13 days, her ALT increased from 29 U/L to 180 U/L, and her AST increased from 30 U/L to 107 U/L. Serologic testing was negative for hepatitis B and C viruses. Ritodrine was stopped and Shanguogen and silibinin were given. Her liver function returned to within normal range 11 days later.
  • 专题研讨
    . 2002, 4(6): 386-389.
  • 学术论坛
    Zhou Chaofan
    . 2009, 11(2): 103-3.
    Chinese herbal medicine injection-induced serious adverse events have been often reported in recent years, and its safety issue has caused widespread concern. This paper generally discusses the relationship between the safety and crude drug quality, prescription ingredients, manufacturing technology, quality control, label revision, clinical use, monitoring and administration, as well as reevaluation.
  • Yang Xinyun;Xiao Liting
    Adverse Drug Reactions Journal. 2009, 11(6): 441-2.
    A 58yearold woman was hospitalized with greater occipital neuralgia. After admission, routine blood examination revealed a WBC count of 4.90×109/L and a platelet count of 273×109/L. Carbamazepine 0.1 g twice daily was given. The next day, the dosage was changed to carbamazeping 0.1 g thrice daily, then clonazepam, rotundine, and lansoprazole were given. Two days later, her headache was exacerbated. The carbamazepine dosage was increased to 0.2 g thrice daily, then paracetamol and dihydrocodeine tablets were added to the regimen. Eight days later, the patient developed diffuse ecchymosis involving her trunk. Routine blood testing showed following values : WBC count 2.87×109/L and PLT count 4×109/L. Carbamazepine was stopped, and other medications were continued. Etamsylate, methylprednisolone, and platelet transfusions were given. After five days of the therapy, his values of blood routine testing normalized.
  • GAO Jie;ZHANG Jing-jing;WANG Jin;ZHANG Wen-wen;YU Di;QIAN Yu-lan;ZHENG Xiao-xian;DING Xiao-liang;MIAO Li-yan
    . 2013, 15(5): 258-5.
    ObjectiveTo explore the correlation between HLA-B*5801 allele and allopurinol-induced severe cutaneous adverse reaction (SCAR) in Han ethnic group patients in Jiangsu province.MethodsThe patients who developed SCAR after receiving allopurinol were enrolled in SCAR group (36 cases), the patients without any adverse reaction receiving allopurinol over 6 months were enrolled in allopurinol control group (50 cases) and 167 healthy volunteers were enrolled in healthy control group. The subjects′peripheral blood samples were taken to detect the HLA-B*5801 allele by sequence-specific primer polymerase chain reaction and polymerase chain reaction-sequencing based typing, in order to analyze the correlation between HLA-B*5801 allele and allopurinol-induced SCAR.ResultsThere were 36 cases in SCAR group comprised 22 males and 14 females with median age of 61 years (21 to 87 years). There were 50 cases in allopurinol control group comprised 42 males and 8 females with median age of 74 years (49 to 93 years). The difference of sexual distribution between 2 groups was statistically significant (P=0.02). The dose of allopurinol in two groups was 0.1-0.3 g everyday and the median dose was 0.2 daily. The subjects in SCAR group developed SCAR 5 to 47 days after receiving allopurinol. The case number of cases with drug hypersensitivity syndrome, Stevens-Johnson syndrome(SJS), toxic epidermal necrolysis (TEN) and SJS/TEN were 20, 10, 3 and 3, respectively. The positive rate of HLA-B*5801 allele was 97.2% (35/36) in SCAR group, 8.0% (4/50) in allopurinol control group, and 12.0%(20/167)in healthy control group. The risk of developing SCAR was significantly higher in subjects with positive HLA-B*5801 allele than those with negative HLA-B*5801 allele (OR=403, 95%CI: 43-3761, P=0.000). The sensitivity and specificity of the HLA-B*5801 allele for prediction of allopurinol-induced SCAR were 97.2% and 92.0%, respectively.ConclusionsThe HLA-B*5801 allele in Han ethnic group in Jiangsu province is highly correlated with allopurinol-induced SCAR. The patients should be received genetic screening before administration of allopurinol, which may decrease the incidence of SCAR induced by allopurinol.
  • LEI Zhao-bao
    . 2013, 15(6): 342-4.
    Dipeptidyl-peptidase Ⅳ (DPP-4) inhibitors are a new class of oral hypoglycemic drugs. These drugs can effectively reduce glycated hemoglobin, as well as have a good tolerability and safety. Acute pancreatitis is a rare, but serious adverse reaction of DPP-4 inhibitors. The latent period of DPP-4 inhibitor induced acute pancreatitis is from 14 to 515 days. The symptom includes abdominal pain, and laboratory examination showed that serum amylase, lipase and elastase levels are markedly elevated. The pathological examination showed diffuse edema and necrosis of pancreas and peripancreatic tissue. The mechanism of DPP-4 inhibitors induced acute pancreatitis mainly relates to the allergy and direct toxicity of the drugs or metabolite to pancreas. DPP-4 inhibitor should be used with caution in patients with a history of pancreatitis. Closely monitoring the clinical presentations and the levels of serum amylase, lipase and elastase during treatment with DPP-4 inhibitors is the effective measure to prevent the occurrence and development of acute pancreatitis.
  • Ding Ling;Hu Yi
    Adverse Drug Reactions Journal. 2010, 12(1): 63-1.
    A 73yearold man received an IV infusion of gatifloxacin 200 mg twice daily for acute attack of chronic obstructive pulmonary disease. Three days later, the patient developed agitation and fear. His symptoms worsened and experienced hallucination, delusion of persecution, and other mental symptoms in the following two days. Gatifloxacin was discontinued and diazepam and chlorpromazine hydrochloride were given. Two days later, abovementioned symptoms subsided.
  • 病例报告
    Zeng Jianming
    . 2007, 9(3): 176-176.
    Initially, a 79-year-old man with prostate hyperplasia and calculus was irregularly given norfloxacin 400mg twice daily, and then the dosage of the drug was increasing. Six years later, the dosage of norfloxacin was increased to 1200mg thrice daily. The patient developed facial pigmentation and it was gradually aggratated. After stopping of the drug, his facial pigmentation faded.
  • 海内外交流
    . 2014, 16(6): 383-2.
  • 论坛
    Luo Leiming
    . 2014, 16(1): 2-5.
  • Yan Tingting, Liu Wei, Yang Li, Chen Ken, Zhai Suodi
    . 2016, 18(5): 356.
    Statins play an important role in prevention of cardiovascular and cerebrovascular diseases for their excellent lipid-lowing efficacy. However, statins can increase the risk of the occurrence of acute kidney injury (AKI) with significant dose correlation. Statins related AKI is associated with acute tubular necrosis when rhabdomyolysis occurred. Statins can lead to proteinuria or elevated serum creatinine levels, most of the changes are transient.  Statins related proteinuria is caused by protein malabsorption in renal tubules. Renal safety of statins is different, rosuvastatin and simvastatin are more likely to cause renal adverse reactions. Atorvastatin and fluvastatin are safer to kidney with little renal excretion. Patients with chronic kidney disease are safe to use statins since they could reduce the risk of cardiovascular events. However before statins therapy starts, risk and benefit evaluation should be carried out, and attentions should be paid to drug selection and dose adjustment.
  • Wang Zhen, Hua Lu
    . 2016, 18(4): 298.
    A 65-year-old female patient took warfarin regularly at a dose of 3.75 mg once daily for atrial fibrillation and cerebral infarction and the INR value was maintained between 1.95-2.12. She ate dried red jujube (50-100 g/d) as nutritional supplements. Three weeks later, she found a hematoma on her left forearm, about the size of duck′s egg, and gross hematuria. The INR increased to 3.22. Warfarin was discontinued. The next day, the hematuria disappeared and the hematoma was alleviated. She continued to eat the jujube. Two days later, the hematoma was absorbed with only an ecchymosis left. On day 4 after warfarin withdrawal, the INR was 1.72. The patient was advised to stop eating the jujube and continue warfarin anticoagulation at a dose of 3.75 mg once daily. Six days later, the INR was 1.78 and the ecchymosis disappeared completely.
  • 病例报告
    Jiang Yuyong;Liu Yang;Hou Yixin
    . 2014, 16(5): 307-3.
    A 49-year-old man suffered from gout and received treatment with allopurinol 0.1 g thrice daily. He mistook the drug 0.3 g thrice daily for 5 days and subsequent regimen was changed to 0.1 g thrice daily. The patient developed fever, skin pruritus and maculopapules 25 days after drug administration. Seven days later, erythroderma appeared on his limbs, face and abdomen. He developed ulcers in mouth, and the bilateral tonsils were covered with large white exudate. Laboratory testing showed the following results: white blood cell count 14.1×109/L, eosinophil count 1 100×106/L, alanine aminotransferase 130 U/L, aspartate aminotransferase 93 U/L, total bilirubin 160.5 μmol/L, direct bilirubin 144.3 μmol/L, blood urea nitrogen 39.2 mmol/L, serum creatinine 628 μmol/L, uric acid 508 μmol/L, and prothrombin activity 61%. Allopurinol-induced hypersensitivity syndrome, drug induced liver injury and acute exacerbation of chronic renal insufficiency were diagnosed. Allopurinol was discontinued and he was given IV infusions of compound glycyrrhizin, glutathione, vitamin C, vitamin B6, imipenem and cilastatin sodium, and human albumin. On day 5 after administration, the patient developed fever, cough and gastrointestinal hemorrhage. Then he was transferred into intensive care unit and received methylprednisolone pulse therapy. The patient developed pulmonary infection, typeⅠrespiratory failure, reduced urine and kidney failure successively in the following two weeks. On day 31 of admission, the patient died from liver and renal failure and septic shock.
  • 病例报告
    Huang Qianqiu①;Wang Yuqin②;Shi Luwen①
    . 2007, 9(3): 189-224.
    A 35-year-old woman with ectopic pregnancy was administered with levofloxacin 0.2g/day and carbazochrome 80mg/day by infusion on different intravenous lines following an exploratory laparotomy. The next day, she developed rash on the limbs shortly after starting of carbazochrome infusion, and then the occurrence of dyspnoea about 20 minutes later. Carbazochrome was stopped and levofloxacin was continued. Two hours later, her symptoms were relieved gradually.
  • 病例报告
    Wu Huijin;Li Chunmin;Zhang Yingfen
    . 2009, 11(5): 374-1.

    A 65yearold man with mycoplasma pneumonia received an IV infusion of cefpiramide 1.0 g twice daily. On day 1 of therapy, the patient developed lightning pain in his right cheek; the pain radiated to the left cheek and forehead, which occurred once every 10 minutes and lasted for 10 seconds. Thirteen days later, he presented with dozens of red papules in different sizes on his skin. Cefpiramide was stopped and switched to clindamycin. Two days later, the pain in his cheek subsided.

  • Chen Yaning;Guo Qiyu;Huang Huogao;Yao Hebin
    Adverse Drug Reactions Journal. 2009, 11(5): 367-2.
    A 45-year-old man with diabetes mellitus received thiamazole 10 mg thrice daily for hyperthyroidism. One month later, the patient experienced repeated episodes of muscular pain which lasted for one minute every time. His creatine kinase was 746 U/L. Thiamazole was stopped. Two weeks later, his symptoms disappeared and the creatine kinase level returned to within normal range. Myalgia recurred after readministration of thiamazole, then thiamazole was discontinued.
  • 病例报告
    Zhou Changfu;Zhang Aixiang
    . 2009, 11(1): 39-2.
    A 50yearold man with a cold and fever received cefalexin 0.25 g capsules thrice daily and metamizole sodium 0.5 g tablets thrice daily. His temperature returned to normal after administration. The next day, the man developed erythema, skin rash with pruritus over his entire body, followed by blister with burning pain. His temperature increased again, and peaked at 40 ℃. After hospitalization, physical examination showed erythema and blister on his face, trunk, and extremities, damaged skin involving 50% of his body surface area, severe conjunctive congestion. Laboratory examination revealed the following values: WBC 18.9×109/L,N 0.78,L 0.12,M 0.10 and ALT 74 U/L. He was diagnosed with toxic bullosa epidermalysis. Cefalexin and metamizole sodium were discontinued immediately. He was treated with dexamethasone, ketotifen, cefoperazone sodiumsulbactam sodium, diammonium glycyrrhizinate. His damaged skin improved to some extent and his temperature decreased to 38.5 ℃. On day 6 after admission, the patient restarted receiving metamizole sodium 0.5 g tablets twice daily for a fever. His erythema became aggravated. The medication was withdrawn immediately. Antianaphylactic therapy was given again. Ten days later, his skin symptoms subsided.
  • 安全信息
    . 2009, 11(3): 223-1.
  • 药物评介
    . 2002, 4(1): 35-37.
  • 调查研究
    Gong Lianbing;Zhang XiaOjun;Zhao wei
    . 2002, 4(3): 156-158.
    Objective: To analyze the causes of drug rash. Method: The medical records of 50 patients with drug rash were reviewed, which occurred during 1995 - 2000 in the 305th hospital of PLA. Results: The leading sensitizing drugs were penicillin, cefazolin. acetylsalicylic acid and sulfonamides. The traditional Chinese herbal preparations accounted for 20%of ADR . Conclusion: In order to reduce the occurrence of the adverse reactions drugs should be used in a rational way, especially for patients with allergic history.
  • 病例报告
    . 2001, 3(2): 121-122.
  • 网络医药
    . 2002, 4(4): 252-256.
  • 病例报告
    . 2005, 7(3): 215-216.
  • 调查研究
    Fu Ying
    . 2005, 7(4): 245-250.
    Objective:To review both positive and negative evidences of links between MMR vaccine and autism. Methods: The original articles in this field were retrieved and analysed through searching engine of Google, Medline and Lancet . Results: Conclusions in five articles focusing on pathogenesis were supportive of the links, and thirteen ones on epidemiological surveys were against the links. By comparison of their scientific nature, the latter was more convincing than the former. Conclusion: The existing information shows no enough evidence for MMR-induced autism. And hypothesis on au-tism due to abnormal MMR immumity in children needs further investigation.
  • Lu Meizhi, Li Wenhao, Yang Shen, Yan Wensheng, Zhang Yunfang
    Adverse Drug Reactions Journal. 2022, 24(11): 606-608. https://doi.org/10.3760/cma.j.cn114015-20220314-00203
    A 62-year-old male patient received aspirin, clopidogrel, and atorvastatin calcium after percutaneous coronary intervention for coronary atherosclerotic heart disease. One week later, the patient received anti-Helicobacter pylori (Hp) therapy with amoxicillin capsules, clarithromycin tablets, bismuth tartrate capsules, and pantoprazole sodium enteric coated tablets due to Hp infection, and two to three days after taking the drugs, the patient developed systemic fatigue, nausea, joint discomfort and muscle soreness, which were gradually aggravated. Laboratory tests showed muscle hemoglobin (MYO)>1-000-μg/L, serum creatinine (Scr) 69-mmol/L, urea nitrogen (BUN) 3.5-mmol/L, alkaline phosphatase (ALP) 148-U/L, alanine aminotransferase (ALT) 750-U/L, aspartate aminotransferase (AST) 850-U/L, g-glutamyl tran- speptidase (γ-GT) 181-U/L, lactate dehydrogenase (LDH) 1-177-U/L, creatine kinase (CK) 8-144-U/L, CK-MB 255-U/L. Atorvastatin calcium was stopped, and symptomatic and supportive treatments such as alkalized urine and fluid replacement were given, and anti-Hp treatments were continued. However, the CK level was continued to increase. CK reached 15-794-U/L 4 days after atorvastatin calcium discontinuation. It was considered that the patient′s rhabdomyolysis might be related to interaction between atorvastatin calcium and clarithromycin. Then the anti-Hp drugs were discontinued. On the 2nd of drug withdrawal, the patients′ muscle soreness was alleviated than before; on the 4th day, CK and other serum enzymology indexes began to decline; on the 8th day, the patient′s fatigue and muscle soreness completely disappeared, with CK 908-U/L; on the 15th day, ALT was 105-U/L, AST was 42-U/L, γ-GT was 107-U/L, CK was 143-U/L, CK-MB was 29-U/L, and LDH was 339-U/L; 5 weeks later, the patient took atorvastatin again, myalgia and fatigue did not recur, and no abnormality was found in blood biochemical indexes.
  • Ma Xiaoyan, Xu Xinmin, Li Ruihong, Li Min, Zhang Yan, Wang Huizhu
    Adverse Drug Reactions Journal. 2021, 23(12): 617-623. https://doi.org/10.3760/cma.j.cn114015-20210518-00586
    Objective To understand the distribution and drug resistance of pathogens isolated from acquired immunodeficiency syndrome (AIDS) inpatients in Beijing area in recent years. Methods The data on strain identification and antimicrobial susceptibility tests of clinical isolates of pathogens from AIDS inpatients in Beijing Ditan Hospital, Capital Medical University between January 2015 and December 2020 were collected and analyzed descriptively and retrospectively. Results A total of 728-strains of pathogens were included in the analysis, mainly isolated from blood samples (292-strains, 40.1%), bronchial lavage fluid samples (116-strains, 15.9%), sputum samples (114-strains, 15.7%), urine samples (83-strains, 11.4%), bone marrow samples (26-strains, 3.6%), cerebrospinal fluid samples (24-strains, 3.3%), and pleural effusion samples (24-strains, 3.3%). Among the 728 pathogenic strains, 235 (32.3%) were Gram-negative bacilli, mainly including Pseudomonas aeruginosa, Escherichia coli, Salmonella spp., and Acinetobacter baumannii; 162 (22.3%) were Gram-positive cocci (22.3%), mainly including coagulase negative staphylococci and Staphylococcus aureus; 139 (19.1%) were mycobacteria, including Mycobacterium tuberculosis and nontuberculous mycobacteria; 108(14.8%) were fungi, mainly including Cryptococcus neoformans and Talaromyces marneffei; 84 (11.5%) were other pathogenic strains. According to the calculation of single strain, the top 5 pathogens were Mycobacterium tuberculosis, coagulase negative staphylococcus, nontuberculous mycobacteria, Pseudomonas aeruginosa, and Escherichia coli suceesively. In comparison with the distribution of pathogens isolated from AIDS patients in the same hospital in 2009-2014, the proportion of Gram-negative bacilli decreased (40.73% from 2009 to 2014), and the proportions of Gram-positive cocci, fungi, and Mycobacterium tuberculosis were similar (19.15%, 14.02%, and 9.27% respectively in 2009-2014), and the proportion of non tuberculosis mycobacteria increased significantly (it was not calculated separately and classified into ‘others’ because of the relatively low proportion, and the proportion of others was 6.34% in 2009-2014) successively. Gram-negative bacilli were mostly isolated from respiratory samples (47.2%, 111/235), followed by urine samples (20.4%, 48/235); Gram-positive cocci were mostly isolated from blood samples (45.7%, 74/162), followed by bone marrow samples (13.0%, 21/162); mycobacteria were mainly isolated from blood samples (72.7%, 101/139), followed by respiratory samples (26.6%, 37/139); fungi were mainly isolated from blood samples (44.4%, 48/108), followed by respiratory samples (19.5%, 21/108) and cerebrospinal fluid samples (17.6%, 19/108). The results of antimicrobial susceptibility tests showed that the resistance rate of Gram-positive cocci decreased and the rate of the Gram-negative bacilli increased obviously in 2015-2020, compared to those in 2009-2014 in clinical isolates from AIDS patients in the same hospital respectively. Conclusion In recent years, the proportion of Gram-negative bacilli  decreases, the proportion of nontuberculous mycobacteria increases significantly, and the drug resistance rate of most Gram-negative bacilli increases significantly in clinical isolates from AIDS inpatients in Beijing.
  • 病例报告
    . 2005, 7(1): 57-58.
    An 81-year-old man was attacked by "sinusitis"and treated with azithromycin 500mg daily one week prior to admission. He felt upper abdominal discomfort and anorexia after taking the medication. It was considered the common side effects associated with azithromycin. The agent was still taken and the symptoms worsened progressively. Afterward, the man developed fever, dark urine and yellow skin. Physical examination revealed a temperature of 38℃,jaundice,tenderness and percussion pain on right upper abdomen and positive Murphy sign. WBC count was 11.4x109/L. Ultrasound showed gall bladder of 5.2x11.2cm. He was diagnosed as drug-induced hepatic damage and acute cholecystitis. His symptoms achieved complete remission after withdrawal of the medication and treatment of impaired liver function and inflammation.
  • WHO信息
    . 2001, 3(4): 266-266.
  • 安全用药
    . 2005, 7(6): 424-427.
    氯胺酮系非巴比妥类速效静脉麻醉药,有良好的镇痛作用,对呼吸抑制作用较轻、因能使气道平滑肌舒张,适用于气道高反应性病人的麻醉而被广泛应用。但该药物对中枢神经系统、呼吸系统、循环系统、消化系统等的不良反应渐为人们所认识,而近年娱乐场所开始流行用其作为致幻剂(K粉)所产生的成瘾性问题,更引起全社会的重视。
  • 病例报告
    Yuan Jina;Xiao Qingb;Wang Xiaoyanc;Shi Leia
    . 2009, 11(4): 286-2.
    A 48yearold women with chronic hepatitis B received entecavir 0.5 g daily for about 15 months, and then she developed asthenia, insomnia, and weight loss. Thyroid function tests revealed the following levels: FT3 17.24 pmol/L, FT4 43.93 pmol/L, and TSH 0.009 mU/L. Hyperthyroidism is considered to be entecavirassociated. Entecavir was withdrawn, and propylthiouracil, propranol, and vitamin B6 were given. Her prognosis was unknown because of lose to followup.
  • 病例报告
    Li Weilan;Shao Hua;Zheng Xiangyu
    . 2009, 11(2): 144-2.
    A 92yearold man with chronic obstructive pulmonary disease received an infusion of moxifloxacin 400 mg once daily and an infusion of cefotaxime 3.0 g three times daily for pulmonary infection. The next day, the patient developed chest distress, palpitation, abnormal vision, listlessness, and subsequently developed dysphoria, auditory hallucination, hallucination, delirium, and aggrevated abnormal vision. Moxifloxacin was stopped and cefotaxime was continued. The following day, his symptoms relieved, and his symptoms disappeared completely five days later.
  • He Hanjun
    Adverse Drug Reactions Journal. 2010, 12(1): 41-2.
    A 52-year-old man with hypertension, hypertensive cardiopathy, and left ventricular hypertrophy received digoxin 0.125 mg once daily, benazepril 10 mg once daily, controlledrelease nifedipine 30 mg once daily, hydrochlorothiazide 25 mg once daily, and spironolactone 20 mg once daily. Seven days later, the patient developed bilateral, symmetrical breast enlargement accompanied by mild pressing pain and hyposexuality. Spironolactone was stopped. Five days later, his conditions relieved. The abovementioned symptoms recurred after readministration of spironolactone and improved markedly after the drug discontinuation again.
  • 不良事件
    . 2004, 6(5): 346-346.
  • 病例报告
    Chen Fuchao;Li Peng;Fang Baoxia
    . 2009, 11(6): 432-1.
    A 69yearold man with allergic dermatitis was given ebastine 10 mg once daily 0.05%, beclometasone cream and 03% ciprofloxacin lactate cream for external application. Fifteen days later, the patient developed aggravated rash and his liver function tests revealed the following values: ALT 173 U/L, AST 120 U/L. Ebastine and ciprofloxcin lactate cream were stopped. Antiallergic and liverprotective treatments were administrated. One week later, his rash improved and liver function returned to within normal range.
  • 中药不良反应
    . 2007, 9(2): 80-80.
  • 中药不良反应
    Liu Changchun
    . 2007, 9(3): 218-219.
    55-year-old woman with a history of 3-year hypothyroidism took levothyroxine sodium 6.25 μg every other day. Recently, she experienced lacunar cerebral infarction and was given IV propylgallate 180mg once daily. The patient presented with a headache and fullness of head while receiving IV propylgallate and oral levothyroxine in the same day. Her blood pressure was increased from previous level of 126130/70 mmHg to 150/90 mmHg. She was given oral losartan potassium 100mg and then her blood pressure was decreased to 140/80 mmHg. Two day later, her blood pressure was increased to 146/90 mmHg following treatment with propylgallate again.
  • 病例报告
    . 2007, 9(1): 50-51.
  • 病例报告
    ZHANG Han-yu
    . 2013, 15(1): 42-2.
    An 81-year-old woman with pulmonary fungal infection received an IV infusion of fluconazole 200 mg once daily. Ten minutes after infusion started, the patient′s electrocardiogram showed frequent ventricular premature beats, and then an IV push of lidocaine and an IV infusion of potassium chloride were given immediately. Ten minutes later, the patient′s electrocardiogram showed torsades de pointes and ventricular fibrillation. She was immediately treated with chest compression and defibrillation, followed by IV lidocaine, IV magnesium sulfate and IV potassium magnesium aspirate. The next day, torsades de pointes and ventricular fibrillation occurred again 5 minutes after an IV infusion of fluconazole. Fluconazole was withdrawn immediately and her therapy was changed to itraconazole injection for antifungal therapy. After this change, her torsades de pointes and ventricular fibrillation did not recur.
  • 病例报告
    GAO Yang;YU Kai-jiang;WANG Hong-liang;LIU Hai-tao
    . 2012, 14(6): 387-3.
    A 47-year-old female patient self-medicated with paracetamol (0.5 g per time) and metamizole sodium (0.25 g per time) for fever, fatigue, cough, and pharyngalgia. She took the drugs irregularly (3-4 times daily for 3 days) and the patient’s symptoms were slightly relieved. On day 4, laboratory tests showed the following values: a lanine transaminase (ALT) 7247 U/L, aspartate transaminase (AST) 2483 U/L, urea nitrogen 28.3 mmol/L, creatinine 630 μmol/L and 12-hour urinary volume for was 400 ml. Hepatic injury and acute renal failure were diagnosed. The treatments including liver protection, fresh frozen plasma infusion, an IV infusion of prostaglandin E1, and continuous renal replacement therapy were given. Four days after treatment, a reexamination showed the following values: ALT 93 U/L, AST 56 U/L, urea nitrogen 19.1 mmol/L, creatinine 166 μmol/L, urinary volume 4000 ml/d and her hepatic and renal functions basically returned to normal.
  • 论著
    SHI Xue*;LIU Zheng-mao;ZHU Xiu-dan;GUO Xiu-hua
    . 2012, 14(3): 137-5.

    ObjectiveTo explore the effects of Fuzheng Jianpi decoction on adverse reactions to chemotherapy in children with solid tumor. Methods The children with solid tumor who were in/out-patients in oncological surgery of Beijing Children’s Hospital during the period from January 2005 to January 2008 were enrolled in the study. The children were divided into the chemotherapy drug group (the control group) and the chemotherapy drug plus Fuzheng Jianpi decoction group (the treatment group) by randomized digital table. The decoction contained 17 Chinese herbs. The time of taking the decoction was from the day before beginning of each chemotherapy cycle to one week after the end of chemotherapy. The peripheral blood cell count, scores for adverse reactions, compliance and the situation of chemotherapy completion in the two groups during the sixth and twelfth month of chemotherapy were observed and compared. ResultsA total of 167 patients were enrolled in the study. The control group (84 cases) comprised 48 boys and 36 girls with average age of (3.8±2.6) years. The treatment group (83 cases) comprised 45 boys and 38 girls with average age of (3.7±2.7) years. The differences in tumor types, tumor stages, white blood cell count, platelet count, and hemoglobin concentration before chemotherapy between the two groups were not statistically significant (P>0.05 for all comparison). The white blood cell count and hemoglobin concentration in the treatment group were higher than those in the control group [(4.2±2.0)×109/L vs (3.1±1.9)×109/L, P<0.01;(95±20) g/L vs (87±15) g/L,P<0.05)], the difference in platelet count between the two groups was not statistically significant (P>0.05) during the sixth month of chemotherapy. Three indexes of children in the treatment group were higher than those in the control group [white blood cell count:(3.8±1.8)×109/L vs (3.0±1.6)×109/L,P<0.01;hemoglobin concentration:(87±23) g/L vs (80±18) g/L, P<0.05;platelet count:(170±65)×109/L vs (146±51)×109/L, P<0.05] during the twelfth month of chemotherapy. Compared with the control group, the severity of vomiting was reduced markedly, activities of daily living, appetite and body weight were increased in the treatment group during the sixth month and the twelfth month of chemotherapy, respectively. The differences were statistically significant (P<0.01 for all comparison). The severity of constipation in the treatment group was lighter than that in the control group during the sixth month of chemotherapy (P<0.01). The severity of pain in the treatment group was lighter than that in the control group during the twelfth month of chemotherapy (P<0.05). The chemotherapy compliance in the treatment group was better than that in the control group [86.7%(72/83) vs 69.0% (58/84), P<0.01)]. The rates of chemotherapy completion in the treatment group was higher than that in the control group [81.9%(68/83) vs 667% (56/84), P<0.05]. ConclusionFuzheng Jianpi decoction can reduce the severity of adverse reactions to chemotherapy and might be used as an adjuvant treatment in children receiving chemotherapy for solid tumor.

  • 病例报告
    YANG Xiao-hui;PENG Yan
    . 2012, 14(2): 118-3.
    An 82-year-old man received lung cancer radiotherapy (44 days) and oral gefitinib 250 mg once daily. The patient presented with rash on day 19, and fever on day 38. On the 47th day, he was diagnosed with radiation-induced lung injury. The patient was cured completely after receiving antibiotics and glucocorticoids. On day 70, the patient developed dyspnea, his respiratory rate was 32 breaths/min, accompanied by cough. Laboratory tests revealed the following results: white blood cell count 4.0×109/L, neutrophils count 3.7×109/L. Blood gas analysis indicated the following: pH 7.06, PaCO2 36 mm Hg, PaO2 45 mm Hg, oxygen saturation 055. Based on his chest X-ray findings and clinical manifestations, gefitinib-associated interstitial pneumonia was considered. Gefitinib was stopped immediately. He received endotracheal intubation, mechanical ventilator, and an IV infusion of meropenem and methylprednisolone. After 1 week of treatment, the symptoms subsided. After 1 week interval, the patient developed dyspnea again. Blood gas analysis indicated the following: pH 743, PaCO2 34 mm Hg, PaO2 40 mm Hg. In a short time period, the patient developed left heart failure, upper gastrointestinal hemorrhage, type Ⅱ respiratory failure, renal and hepatic insufficiency, acute myocardial infarction successively. Despite treatment with liver-protective drugs and diuretics, the patient rapidly progressed to multiorgan failure and eventually died.
  • Adverse Drug Reactions Journal. 2017, 19(6): 448.
  • WANG Dong;CAO Jiang;JIANG Xue-wei;BAI Nan;WEN Ke;ZHANG Yong;WANG Jin;WANG Rui
    . 2013, 15(6): 325-5.
    ObjectiveTo investigate the research progress and clinical and pathological characteristics of visual disturbances due to voriconazole, in order to provide a reference for clinical safety use of voriconazole.Methods“Voriconazole” or “vfend” + characterized word of visual disturbances, “voriconazole” + “adverse reactions” were selected as the keywords and PubMed, Embase, Web of Science, CNKI and Chinese Medical Citation Index were searched. All literatures about visual disturbances due to voriconazole were selected. The evaluated databases of literatures accepted for bibliometric study was established by Microsoft Excel. The indexes of bibliometrics such as published time of literature, literature′s type, the first author′s country and institution, loaded media, number of papers and citation rates were recorded and analyzed. The clinical and pathological parameters of visual disturbances due to voriconazole such as clinical manifestations, degree of severity, prognosis, mechanism, prevention and treatment were recorded and analyzed.ResultsA total of 119 articles (92 in English and 27 in Chinese) were enrolled in the study, of which 61 were original articles, 36 reviews, 17 case reports, and 5 conference papers. The publication time of first original publication of visual disturbances due to voriconazole in abroad and China were 1999 and 2008, respectively. The area distribution of the first authors of 92 English articles were Europe (33 pieces, 359%), North America (27 pieces, 30.4%), Asia (26 pieces, 28.3%), Oceania (5 pieces, 54%) and South America (1 piece, 1.1%), respectively. The highest cited rates of English and Chinese article were 1542 and 17 times, respectively. Visual disturbances due to voriconazole usually occurred in the first week after administration. Intravenous administration was more easily lead to visual disturbance than oral administration. The main clinical manifestations of visual disturbance were visual disturbances, involuntary vision disorder, visual impairment, visual abnormalities, color change and light flash. Most patients′ vision could recover within 1 to 3 days spontaneously. The mechanism of visual disturbances due to voriconazole might be related to the dysfunction of rod and cone type optical nerve bipolar cells.ConclusionsEurope and Unite State are ahead of China in the research on visual disturbance due to voriconazole. Visual disturbances due to voriconazole is transient and reversible. Voriconazole is relatively safe in clinical practice.
  • 病例报告
    Liu Na;Hou Caiyan;Zhang Weiyi;Li Jin
    . 2010, 12(5): 364-2.
    A 36yearold man with leukemia received an IV infusion of vancomycin 1 g in 0.9% sodium chloride 100 mL once every 12 hours and an IV infusion of moxfloxacin 0.4 g once every 12 hours for respiratory infections. Three days later, laboratory tests revealed the following levels: SCr 549 μmol/L, BUN 11.17 mmol/L, serum K+ 3.76 mmol/L. Vancomycin was withdrawn and changed to linezolid. Moxfloxacin was continued. The patient’s condition continued to worsen and he developed nausea, edema in lower limbs, and abdominal distension. His urine volume was 1000 mL/d. Meanwhile his SCr level was 848 μmol/L and BUN level was 19.8 mmol/L. Subsequently, he received hemofiltration. After three times of hemofiltration, his symptoms disappeared and renal function indices returned to within the normal range.
  • 论著
    Li Yan;Liu Yongjun;Qin Chao;Chen Wei;Xu Meng;Liu Guangyang;Zhu Delin;Gao Hong
    . 2011, 13(2): 78-7.
    Objective: To investigate the immune toxicity of human umbilical cord mesenchymal stem cells (UCMSC) on Wistar rats. Methods: One hundred and twelve SPF grade Wistar rats were randomly divided into 4 groups: the solvent group (a dose of solvents 5 ml/kg), the lowdose group (a dose of 1×107 human UCMSC/kg), the highdose group (a dose of 5×107 human UCMSC/kg) and the control group (a dose of 1×107 rat UCMSC/kg). Each group comprised 28 rats (14 males and 14 females). UCMSC once every 2 weeks was given via the caudal vein for 4 doses. The graft versus host diseases (GVHD) scores were evaluated every week after the UCMSC injection start. The IgG and IgM levels and the numbers of T cell subtypes (CD3+, CD4+, and CD8+) were measured. The pathological changes in lymphonode, thymus and spleen were observed and organ coefficients were calculated 1 and 13 weeks after the final dose of UCMSC. Results: The GVHD scores were 0 after injection of UCMSC in all groups. One week after the final dose of UCMSC, the IgG and IgM levels of female rats in the lowdose group[ (0.65±0.12) and (0.63±0.14)g/L, respectively]and the highdose group[ (0.06±0.01) and (0.06±0.01) g/L, respectively] increased markedly than those in the solvent group [(0.41±0.17) g/L and (0.04±0.01) g/L, P<0.05 and P<0.01, respectively]. Thirteen weeks after the final dose of UCMSC, the IgM level of the male rats in the highdose group [(0.05±0.01) g/L] increased markedly than that in the solvent group [(0.03±0.01) g/L, P<0.05]. The IgM levels of male and female rats in the control group [(0.06±0.02) and (0.05±0.02) g/L, respectively]increased markedly than those in the solvent group [(0.05±0.02) g/L, both P<0.05]. There were no statistically differences in the IgG and IgM levels of male and female rats among groups 13 weeks after the final dose of UCMSC (all P<0.05). One week after the final dose of UCMSC, the spleen coefficient of female rats in the lowdose group[(0.274±0.016) %] and the highdose group [(0.294±0.019) %] increased markedly than that in the solvent group [(0.232±0.012)%, P<0.01]. The spleen coefficient of male rats in the highdose group [(0.242±0.027)%] increased markedly than that in the solvent group [(0.202±0.012)%, P<0.01]. The spleen coefficient of male and female rats in the control group [(0.261±0.019)% and (0.236±0.014)%, respectively] increased markedly than that in the solvent group (P<0.01). There were no statistically differences in the spleen and thymus coefficients among groups 13 weeks after the final dose of UCMSC (all P>0.05). The percentage of CD3+, CD4+, and CD8+ T cells and ratio of CD4+/CD8+ in all groups were within the normal range. The histopathological examination of thymus, lymphonode and spleen showed no abnormal changes. Conclusion: Human umbilical cord mesenchymal stem cells can induce elevation of immunoglobulin level and spleen coefficients in Wistar rats, and this effect is transient and reversible.
  • 综合报道
    . 1999, 1(3): 173-176.
    本文概述革兰氏阴性杆菌、葡萄球菌、肠球菌、肺炎球菌、淋球菌等对多种抗菌药物的高度耐药现状及临床应对原则,在使用青霉素类、头孢菌素类、万古霉素等药物时尤要慎重。
  • 中药不良反应
    Li Lihua;Jiang Wei;Liu Lu;Zhang Jing
    . 2007, 9(3): 216-216.
    A 46-year-old woman was admitted with cerebral infarction. She was given Xueshuantong injection 0.6g in 250 ml glucose 5% by intravenous infusion. After about 50 min of infusion, she developed severe dysphoria, hypodynamia and hidrosis. Laboratory tests revealed a potassium level of 2.7 mmol/L. An ECG showed flattened T and heightened U waves. After receiving of symptomatic therapy, the potassium level was increased to 4.5 mmol/L. Three hours later, the patient fell into sleep quietly. The next day, the symptoms were relieved completely.
  • 中毒救治
    He Yuhua
    . 2007, 9(3): 193-193.
    A 57-year-old woman with rheumatoid arthritis took an overdose of aconite. One day later, she presented with general numbness, palpitation, nausea, and vomit. Aconite poisoning was diagnosed. She was given atropine 0.5mg by intramuscular injection and then atropine 1mg by intravenous drip. All the symptoms disappeared after symptomatic treatment.
  • 病例报告
    Song Yan;Li Hui
    . 2007, 9(6): 439-439.
    A 57-year-old woman was scheduled to undergo the second cycle of chemotherapy for right small cell lung cancer.She was given granisetron and diphenhydramine for pretreatment.Then she received intravenous infusion of teniposide 100 mg dissolved in 250 ml of glucose injection 5% at a speed of 60 drops/min.About two minutes after initiation of the infusion,the patient suddenly developed breath holding and cyanosis,and then loss of consciousness,cardiac and respiratory arrest.The infusion was stopped immediately,and she was given cardiopulmonary resuscitation,elevation of blood pressure and anti-anaphylactic treatment.Ten minutes later,her respiration and heartbeat recovered.She had a heart rate of 150~160 beats/min and a blood pressure of 100/60 mmHg.A large area of red skin rash appeared on her body.The anti-allergic and anti-shock therapy was continued and her skin rash resolved after 12 hours.And 17 hours later,the patient's consciousness recovered and her general condition improved.
  • 病例报告
    . 2004, 6(6): 373-373.
  • 病例报告
    Cai Yana;Yang Pinglinb;Zang Quanjinb;Bao Hea
    . 2009, 11(6): 444-2.
    Two female patients, respectively aged 54 and 50 years, received an IV infusion of cinepazide maleate 320 mg dissolved in 5% glucose 500 ml after undergoing lumbar operation. During infusion, the patients developed pain in both lower extremities and their symptoms relieved gradually after stopping cinepazide maleate. On day 2, the abovementioned symptoms recurred after readministration of cinepazide maleate in patient 1 and improved after the drug discontinuation
  • 病例报告
    Wang Shaobing;Xiao Houping
    . 2008, 10(5): 0-0.

    A 58-year-old woman, who has a history of penicillin allergy, was treated with an IV infusion of enoxacin glyconate 0.4 g once daily for hemorrhoids infection. On days 1 and 2 of therapy, the woman developed nausea and anorexia. On day 3, the patient experienced visual loss, reduced hearing, trembling limbs, and dysphoria about 30 minutes after treatment. Her symptoms resolved after promethazine and calcium gluconate were administered. Enoxacin was stopped and the abovementioned symptoms did not reappear.

  • 安全用药
    Yang Bo;Zhu Liqin;Wu Zhiheng;Zhu Tieliang
    . 2009, 11(5): 340-6.
    Continuous renal replacement therapy (CRRT) is one of the important advance in critical care medicine in recent years. CRRT is commonly used in treatment of critically ill patients with or without renal failure. Many critically ill patients with acute renal failure often have severe infections and require antibacterial therapy. However, drug clearance is variable in critically ill patients receiving CRRT. Therefore, many antiinfective drugs cannot reach or maintain an effective therapeutic concentration leading to decrease in their efficacy and promoting the development of resistant bacteria. The factors influencing the effects of antiinfective drugs are CRRT mechanical factors and drug factors; and drug factors include the rate of proteinbinding, metabolic pathway, molecular mass, apparent volume of distribution, and molecular charge. For this reasons, monitoring for blood drug concentration during CRRT should be performed, and the dosage of antiinfective drugs should be adjusted according to the results of monitoring in order to achieve a desired therapeutic efficacy.
  • 中毒救治
    . 2006, 8(5): 370-370.
  • 中毒救治
    . 2006, 8(3): 204-205.
    目的:探讨树脂吸附剂治疗急性摇头丸中毒的疗效。方法:将36例急性摇头丸中毒患者随机分为常规治疗组(常规组)和常规治疗基础上加树脂吸附治疗组(树脂组),观察比较治疗后3、6、12h两组的疗效、副作用和并发症。结果:治疗组的疗效明显优于对照组(H=3.9,P<0.05),尤其是6h时疗效更佳(H=10.4,P<0.01);2组均未发现明显的副作用和并发症。结论:树脂吸附能迅速清除血液中的有毒物质,可有效治疗急性摇头丸中毒。
  • 监测交流
    . 2005, 7(3): 221-223.
  • 病例报告
    . 2002, 4(4): 237-237.
  • 病例报告
    Yang Mu;Ren Wei
    . 2009, 11(2): 121-2.
    A 68yearold man with diabetes mellitus and renal disease received an IV infusion of vancomycin 0.5 g diluted in 0.9% sodium chloride 250 ml once daily. Three days later, his WBC and neutronphil decreased from 14.3×109//L and 0.90 to 1.1×109//L and 0.45, respectively. Vancomycin was discontinued and SC filgrastim 150 μg was given. The following day, he died from hypotensive shock.
  • Yao Danlin;Yang Geng;Liang Ying;Cheng Yao;Wang Jing
    Adverse Drug Reactions Journal. 2009, 11(4): 296-2.
    A 42yearold man received an IV infusion of dexamethasone 10 mg, lincomycin 1.8 g, and ribavirin 0.2 g in 100 ml of glucose 50% for upper respiratory tract infection. Two hours after infusion completion, the patient developed weakness in his extremities, difficulty walking, muscular hypotonia in the extremities, and lose of tendon reflex. An ECG revealed flattened T waves and increased U waves. His serum potassium level was 1.7 mmol/L. Hypokalemia was diagnosed. He was treated with oral and intravenous potassium supplements. After 16 hours, his muscular strength normalized and his serum potassium level increased to 3.8 mmol/L.
  • 临床论著
    Luo Tao;Zhang Jian;Chen Bing;Li Jianxin;Yu Hengxi;Gu Yongquan;Cui Shijun;Yang Shengjia;Qi Yixia
    . 2009, 11(5): 310-5.

    Objective: To assess the efficacy and safety of homemade lipoprostagladin E1 injection in the treatment of peripheral arterial occlusive disease. Methods:A randomized, controlled study was conducted by Xuanwu Hospital of Capital Medical University. From September 2006 to September 2007, 207 patients with peripheral arterial occlusive disease were enrolled in the study and divided into two groups: the homemade lipoprostagladin E1 group (101 cases) and the non-homemade lipoprostagladin E1 group (106 cases ). The homemade lipoprostagladin E1 group comprised 72 males and 29 females with an average age of (63.8±9.3) years. The non-homemade lipoprostagladin E1 group comprised 67 males and 39 females with an average age of (63.7±8.4) years. The patients in both groups were administered an IV infusion of the homemade lipoprostagladin E1 10 μg and nonhomemade lipoprostagladin E110 μg via Murphy’s dropper once daily for 2 weeks, respectively. Rest pain score, anklebrachial index, maximal painless walking distance, and the area of ischemic ulceration were recorded before treatment and on the day of treatment end , and adverse reactions were observed during treatment. Results: In the homemade lipoprostagladin E1 and nonhomemade lipoprostagladin E1 groups, the rest pain scores were (1.30±1.54) and (1.52±1.74) after 2 weeks of treatment as well as (2.37±2.17) and (2.38±2.29) before treatment; the differences were statistically significant (P<0.01, P<0.001), but there was no statistically significant difference between the two groups(P>0.05); the anklebrachial indexes were (0.76±0.22) and (0.74±0.22) after treatment as well as (0.68±0.20) and (0.66±0.21) before treatment, respectively; the differences were statistically significant (P<0.05, P< 0.01), but there was no statistically significant difference between the two groups (P> 0.05). The improvement rate of the walking distance of patients with claudication was 10.34% and 16.13% before and after treatment, respectively; there was no statistically significant difference between the two groups(P>0.05). The difference in the area of ischemic ulceration was not statistically significant before and after treatment (P>0.05). In the homemade lipoprostagladin E1 group, 9 patients developed adverse reactions including elevated liver aminotransferase (3 cases), phlebitis (3 cases), dermatitis (1 case), abnormal WBC count (1 case), elevated INR (1 case); the incidence was 8.9%. In the non-homemade lipoprostagladin E1, 8 patients developed adverse reactions including phlebitis (2 cases), dermatitis (1 case), gastrointestinal uncomfort (1 case), palpitation (1 case), chest distress (1 case), abnormal WBC count (1 case), and fatigue (1 case); the incidence was 7.5%. The difference in the incidence of adverse reactions was not statistically significant between the two groups (P>0.05). Conclusion: The homemade lipoprostagladin E1 injection is a safe and effective agent for treatment of peripheral arterial occlusive disease.

  • 病例报告
    Jing Baojie
    . 2007, 9(6): 433-433.
    A 30-year-old woman with hepatic echinococcosis received oral mebendazole 200 mg twice daily after operation.Ten days later,her level of ALT increased to 101 U/L.The doage of mebendazole was decreased to 100 mg twice daily.Twenty days later,her ALT increased to 200 U/L.After liver-protective treatment,the patient's liver function returned to normal levels.Then mebendazole was continued.The level of ALT increased to 300 U/L.Mebendazole was discontinued.Half a month later,the patient's ALT was 605 U/L,and Tbil was 126 μmol/L.And she developed anorexia and dark yellow urine.The patient was given liver-protective and symptomatic treatment.Twenty-five days later,her symptom improved and liver function normalized.
  • 病例报告
    . 2000, 2(1): 52-53.
  • 病例报告
    Liu Xiao;Liang Yan
    . 2010, 12(5): 365-2.
    A 54yearold woman with coronary heart disease irregularly received Guanxinsuhe capsules for about 10 years(approximate 200 capsules per year). Recently, she took 2 paracetamolcontaining Ganmao capsules three times daily and intermittently took paracetamol( 20 capsules in total) for her fever and respiratory tract infection. Two weeks later, the patient developed nausea and oliguria. Her urine volume decreased to 150 mL/day. Renal function test revealed SCr 997.6 μmol/L and BUN 18.67 mmol/L. Acute interstitial nephritis and renal failure were diagnosed. The renal injury was considered to be related to paracetamol combined with aristolochic acidscontaining Guanxinsuhe capsules. All drugs were discontinued. The patient was treated with methylprednisolone and hemodialysis. One month later, her urine volume increased to 2000 mL/day and other indices almost normalised, and then she was discharged.
  • 中毒救治
    Lü Fangfanga;Li Guoqianga;Lu Gangb;Yang Boc
    . 2010, 12(4): 273-3.
    Three patients (2 men and 1 woman), aged 14, 4, 37 years, took wild mushrooms picked by themselves. One day later, the 3 patients presented with nausea, vomiting, abdominal pain, diarrhea and other gastrointestinal symptoms. The abovementioned symptoms did not relieve after treatments, and liver and cardiac muscle damage occurred. Four days later, the three patients experienced yellowish skin and sclera. Meanwhile the laboratory tests revealed ALT 1 101-6 580 U/L, AST 715-1 965 U/L, TBil 38.5-153.2 μmol/L, DBil 16.9-63.1 μmol/L, IBil 21.6-90.1 μmol/L, LDH 1 036-2 234 U/L, CK-MB 18-36 U/L, CK 30-669 U/L. Toxic mushroom poisoning and liver failure were diagnosed. The three patients were given with albumin dialysis, plasmapheresis, and symptomatic and supportive treatments. The patients’condition improved and were discharged after 14 days of hospitalization.
  • LI Xiang;XU Liang;CAI Ming
    . 2013, 15(6): 359-2.
    A 29-year-old male patient after kidney transplantation underwent enhanced CT examination for the transplant renal dysfunction and received intravenous diatrizoate meglumine injection 20 ml (12 g ). Twelve hours later, the patient developed illness and more secretion in throat followed by slight neck swelling. Twenty hours later, his symptom aggravated and dyspnea, dysphagia, and hoarseness appeared. Physical examination showed obvious neck swelling and enlargement and slight generalized edema. Intravenous dexamethasone 10 mg and aerosol inhalation of budesonide 1 mg were given immediately and, in the meantime, he underwent electrocardiographic monitoring and oxygen inhalation. About four hours later, his condition improved and, two days later, the anaphylactic symptoms disappeared.
  • 病例报告
    LIU Jia;XU Jian-guo;ZOU Ying
    . 2013, 15(1): 41-2.
    A 45-year-old male patient with dilated cardiomyopathy, atrial fibrillation, pulmonary arterial hypertension, and heart failure received torasemide, furosemide, spironolactone, perindopril, metoprolol, cefodizime, and polyene phosphatidylcholine. At the same time, he was administered warfarin 2.5 mg once daily. On day 3, laboratory examination showed the following results: international normalized ratio (INR) 1.16, urea 8.9 mmol/L, uric acid 625 μmol/L. Benzbromarone 50 mg thrice daily was added to his treatment regimen. The next day, his INR value increased to 3.43. On day 9, His INR value increased to 4.56 and warfarin was stopped at the same time. On the seventh day after warfarin discontinuation, his INR value decreased to 1.28. On day 14, he was readministered warfarin 2.5 mg once daily. Six days later, his INR value increased to 3.52. Benzbromarone was stopped at the same day, and warfarin was withdrawn on the second day. Three days later, his INR value decreased to 1.98.
  • Zhou Xiaoming,Tan Hao,Chen Yu,Zhao Limei,Zhao Li
    . 2016, 18(6): 429.

    ObjectiveTo explore the safety and efficacy of recombinant tissue-type plasminogen activator (rtPA) and to do the literature case reviewMethods The related data-bases were searched. The literatures about treatment for pregnant women with  pulmonary embolism by rtPA was collected. The patients′basic information, the situation of fibrinolytic therapy (including type, dosage, and usage of rtPA, and the outcomes of fibrinolytic therapy), the occurrence of ADR, and the outcomes of pregnancy were recorded. A descriptive statistical analysis for the above-mentioned results was performed.ResultsReports involving 16 patients were enrolled into the study, 15 papers in English and 1 in Chinese. The average age of the 16 patients were (32±6) years (21-40 years). The numbers of cases in early, interim, and late stage of pregnancy were 6 (37.5%), 4 (25.0%) and 6 (37.5%), respectively. The patient′clinical manifestations included shock (11 cases), chest pain (8 cases), dyspnea (8 cases), syncope (2 cases),  with blood pressure 67-122/40-87mmHg,  heart rate 106-158 beats/min, and oxyhemoglobin saturation 79%-96%. The number of patients who were diagnosed as acute pulmonary embolism by color doppler echocardiography, pulmonary ventilation and perfusion scan, and spiral CT pulmonary arteriography were 13, 6 and 2, respectively. Fifteen patients received ateplase for fibrinolytic therapy, among them 14 cases′dosages were 41-100 mg/2.0-4.5 hours, another patient had no record of dosage. One patient received monteplase for fibrinolytic therapy, the dosage was 1 600 000 U/2 hours. The route of administration was intravenous injection. After 14 days of fibrinolytic therapy, a patient died of recurrent pulmonary embolism. The other patients′all clinical manifestations disappeared. Four patients (25%) had bleeding after fibrinolytic therapy. Two of the 4 patients presented with vaginal bleeding during childbirth, the amount of bleeding were  8 900 ml and 2 238 ml, respectively. Their vaginal bleeding was stopped after the blood transfusion therapy. The other 2 of the 4 patients had bleeding at puncture site and nose, respectively. The bleeding was stopped after 48 hours by local compression. The outcome of pregnancy showed that 13 of the 16 pregnant woman delivered live births including one case of premature delivery and placental abruption. Two of the other three of the 16 pregnant women underwent voluntary induction of labor in early pregnancy and one had abortion due to dead fetus in uterus after 28 weeks of pregnancy. There was a live-born infant who died from acute respiratory distress syndrome on 14th day after birth in 13 live-born infants.ConclusionTreatment with rtPA for thrombolytic therapy is effective and relatively safe for the pregnant women with pulmonary embolism.

  • Shu Wenlin, Su Zhijian
    . 2017, 19(6): 467.
    A 62-year-old female patient with left knee osteoarthritis was treated with an IV infusion of compound ossotide injection 90 mg dissolving in 0.9% sodium chloride injection 250 ml once a day. About 5 minutes after IV infusion on the first day, the patient complained of chest tightness, dyspnea, cold sweat, upper eyelid edema, cyanosis, and vomiting of pale yellow stomach contents. Her blood pressure was 101/72 mmHg, heart rate was 103 beats per minute, breathing rate was 25 times per minute. Compound ossotide injection was discontinued immediately. She was given an intravenous injection of dexamethasone 5 mg and an intramuscular injection of adrenaline 1 mg. About 20 minutes later, her blood pressure decreased to 39/24 mmHg, pulse rate was 59 beats per minute, breathing rate was 24 times per minute. She developed urinary and fecal incontinence and drowsiness. The patient was diagnosed as anaphylactic shock caused by compound ossotide injection. She was given an intramuscular injection of adrenaline 1 mg again, an IV infusion of dopamine 160 mg, and symptomatic treatment. About 40 minutes later, her heart rate was 70 beats per minute, blood pressure was 95/56 mmHg, breathing rate was 12 times per minute. The patient sequentially received an IV infusion of methylprednisolone 40 mg and an intravenous injection of dopamine 10 mg. About 20 minutes later, the patient regained consciousness. Methylepinephrine 10 mg and  dopamine 180 mg were pumped with gradually reduced speed. Twelve hours later, the patient′s symptoms disappeared. Her body temperature was 36.4 ℃, heart rate was 54 beats per minute, breathing rate was 19 times per minute, and blood pressure was 94/57 mmHg.
  • Ye Xiaolan, Zheng Xiaochun, Yang Xiuli, Zhang Guobing
    A 63-year-old male patient presented with diarrhea at the previous night after taking colchicine by himself for acute gout attacks and then he changed to take diclofenac sodium himself (75 mg twice daily) for 3 days. On the third day after diclofenac sodium treatment, nausea and vomiting occurred, then the drug was stopped (the total dose was 375 mg). Two days after the drug withdrawal, the patient successively developed reduced urine output and chest discomfort. Laboratory tests showed serum creatinine 758.4 μmol/L, blood urea 13.9 mmol/L, and blood potassium 3.1 mmol/L. He was diagnosed as having acute kidney disease (AKI) and was admitted to the Department of Nephrology. After admission, he received oral compound α-Ketoacid tablets (4 pills thrice daily), benidipine tablets (4 mg once daily) and Jinshuibao capsules (金水宝胶囊, 1.98 g thrice daily), and was asked to drink more water. On the 7th day after the drug withdrawal, renal biopsy was performed and the histopathological examination result of renal tissue showed acute tubular damage. The above-mentioned treatments were continued and the patient′s renal function was improved gradually. On the 24th day after diclofenac sodium withdrawal, his serum creatinine was 89 μmol/L and blood urea was 7.5 mmol/L. Diclofenac sodium-associated AKI was considered.
  • Luo Jingjing, Wu Xin′an, Xue Gang, Li Jiahua, Rong Chengting
    Adverse Drug Reactions Journal. 2021, 23(4): 221-223. https://doi.org/10.3760/cma.j.cn114015-20201105-01108
    A 55-year-old male patient had received a variety of antibiotics including vancomycin for injection for sepsis and pulmonary infection after the trauma surgery for multiple fractures due to a traffic accident, which caused antibiotic-associated diarrhea and bullous rash. But the exact allergenic drug was unknown. After the infection was improved, the above antibiotics were discontinued and loratadine 10-mg orally once daily was given, and the rash gradually subsided. The patient had another pulmonary infection during trauma recovery period and was given an IV infusion of cefoperazone sodium and sulbactam sodium 3 g once per 12-hours. After the treatment, the patient′s antibiotic-associated diarrhea worsened, then cefoperazone sodium and sulbactam sodium was discontinued, and vancomycin 0.5 g orally once per 6 hours was given. About 1 hour after the 4th dose of oral vancomycin, the patient developed skin erythema on the neck, which quickly spread to the upper chest, without fever or itching. Red man syndrome caused by oral vancomycin was considered after a dermatologist consultation. Vancomycin was discontinued, an intravenous injection of dexamethasone 5-mg and an intramuscular injection promethazine 25-mg were given, and loratadine was continued. The erythema began to subside and the diarrhea occurred less after 4 days of drug withdrawal. After 7 days of drug withdrawal, the patient′s diarrhea was improved and her skin erythema largely subsided.
  • 病例报告
    Duan Yanlong;Wang Bin;Ma Xiaoli;Zhang Dawei;Yang Jing;Zhang Yonghong
    . 2010, 12(3): 204-3.

    A boy aged ten years and eight months with nonHodgkin lymphoma was hospitalized for chemotherapy. On day 8, 15, and 22 of chemotherapy, the patient received an IV push of vincristine 2 mg once daily and an IV infusion of daunorubicin 50 mg via pump. Fortytwo hours after the third administration of daunorubicin, he suddenly developed confusion, mydriasis, disappeared light reflex, respiratory arrest, undetectable blood pressure, ventricular fibrillation. Electrocardiogram showed cardiac arrest. The resuscitations were given immediately and, two minutes later, he experienced sinus rhythm and his consciousness recovered gradually. Subsequently, he presented with another two similar episodes and each episode lasted for about 10 minutes. Three days later, a 24hour ECG revealed 9 isolated atrial premature beats, 1 ventricular premature beat, and widespread STsegment changes. At 2year follow up, daunorubicin was not given and vincristine was continued, and the patient had no recurrence of similar episode.

  • 法规准则
    . 2007, 9(5): 349-353.
  • 病例报告
    Chen Hong
    . 2008, 10(2): 99-1.

    A 5yearold boy with a cold and fever was treated with azithromycin 0.25 g dissolved in 250 ml of glucose 5% intravenously once daily for 3 days. And then he developed hypodynamia and anorexia. His ALT level increased to 351 U/L. The patients condition improved gradually after treatment with proheparin and vitamin C. Fourteen days later, his ALT level returned to normal limits. The boy was fully recovered.

  • 病例报告
    Li Hui;Wang Meikang;Han Ying;Wang Ying;Zhao Yangong
    . 2009, 11(2): 113-2.
    A 47yearold man received an intravenous injection of microvesicle sulfur hexafluoride 59 mg dissolved in 5 ml of sodium chloride 0.9% for abdominal contrastenhanced ultrasonography 40 days or more after cholecystectomy. He abruptly experienced chest distress, dizziness, nausea, pale face, cold sweat, dyspnea, and a short period of unconsciousness during intravenous injection. Physical examination showed a temperature of 35.8℃, a pulse rate of 100 beats/min,a respiratory rate of 25 breaths/min, and a BP of 40/0 mmHg. Meanwhile generalized skin flush, conjunctival congestion, and palpebral edema occurred. ECG revealed sinus tachycardia. His blood potassium, blood sodium, blood chlorine levels were 2.63 mmol/L, 142 mmol/L, and 103 mmol/L,respectively. Anaphylactic shock was diagnosed. He received oxygen inhalation therapy, and dexamethasone, adrenalin, dopamine, metaraminol, potassium chloride, and sodium bicarbonate were administered intravenously immediately. Later, his blood pressure and electrolytes normalized and his symptoms disappeared gradually.
  • 论著
    Tao Ximin;Shi Shanyu;Gao Wenbin;Han Jindi
    . 2008, 10(3): 163-5.

    Objective: To observe and evaluate the safety of topotecan and hydroxycamptothecine in treating patients with brain metastatic carcinoma. Methods: Eightysix patients clinically diagnosed as having brain metastatic carcinoma entered the study from April 2004 to December 2007. The primary carcinoma of the patients was small cell lung carcinoma (26 cases), nonsmall cell lung carcinoma (32 cases), and mammary cancer (28 cases). The 86 patients were randomly divided into two treatment groups: the topotecan group (44 cases) and the hydroxycamptothecine group (42 cases). The patients in the topotecan group were treated with topotecan 0.8~1.0 mg/(m2·d) in 100~150 ml of sodium chloride 0.9% or glucose 5%, by intravenous infusion within 30 min on day 1~5. The patients in the hydroxycamptothecine group were treated with hydroxycamptothecine 4.0~6.0 mg/(m2·d) in 100~150 ml of sodium chloride 0.9% or glucose 5%, by intravenous infusion within 30 min on day 1~5. The chemotherapy was 2 cycles, and one cycle was 21 days. The curative effects were evaluated in the end of the second cycle. The response rate, clinical benefit rate, and adverse reactions were evaluated and compared between the two groups. Results: Two cycles of chemotherapy and evaluation of efficacy were accomplished in 84 cases of the two groups. The percentage of accomplishment was 97.6%. The response rate and clinical benefit rate of topotecan versus hydroxycamptothecine were 37.21 vs 36.59% and 81.40% vs 73.17%, respectively. There were no statistical differences (P>0.05). The manifestation of blood toxicity was leukocytopenia and thrombocytopenia. The leukocytopenia and thrombocytopenia in Ⅲ~Ⅳ degrees were 29.55% and 13.64% in the topotecan group, respectively, and 7.14% and 2.38% in the hydroxycamptothecine group, respectively. There were marked differences between the two groups (P<0.05). Conclusion: Low-dose topotecan and hydroxycamptothecine have a relatively good therapeutic effect, safety, and tolerance in the treatment of brain metastatic carcinoma.

  • 病例报告
    . 2000, 2(3): 193-193.
  • 病例报告
    . 2003, 5(1): 50-50.
  • Wang Wei, Jia Zhixiang, Zhou Hua
    Adverse Drug Reactions Journal. 2023, 25(1): 57-59. https://doi.org/10.3760/cma.j.cn114015-20220315-00204
    A 37-year-old male patient was treated with tacrolimus, sirolimus, and methylpredniso- lone after renal transplantation to prevent rejection reaction. The function of the transplanted kidney recovered, serum creatinine was about 130-μmol/L, and serum uric acid was about 350-μmol/L. After 2 years and 6 months of renal transplantation, sirolimus was switched to mizolibin due to edema of his lower extremities. After taking mizolibin for 21 days, the patient developed nausea, poor appetite, and decreased urine volume (1 500-ml/24-h), and the symptoms gradually worsened. Laboratory tests showed serum crea- tinine 635-μmol/L and serum uric acid 1-750-μmol/L. The color Doppler ultrasonography of the transplanted kidney showed multiple stones and decreased color of blood flow signal. Acute renal failure, hyperuricemia, and calculus in transplanted kidney were diagnosed. Considering that it was related to mizolibin, the drug was discontinued and replaced by sirolimus, and hemodialysis, uric acid lowering, alkalizing urine, and other treatments were given. After 6 days of mizolibin discontinuation, the patient had no nausea or poor appetite. His urine volume was 3-000-ml/24-h, serum creatinine was 247-μmol/L and serum uric acid was 207-μmol/L. The color Doppler ultrasonography of the transplanted kidney showed no stone with abundant colorful blood flow signals. After 13 days of mizolibin discontinuation, the serum creatinine was 156-μmol/L and the serum uric acid was 123-μmol/L.
  • Yang Wenjuan, Sun Zhe, Yang Canyu, Liu Fang
    Adverse Drug Reactions Journal. 2023, 25(4): 253-254. https://doi.org/10.3760/cma.j.cn114015-20220812-00742
    An 85-year-old male patient received left thyroxine sodium (LT4) 50 μg orally once daily for replacement therapy because of ischemic stroke and hypothyroidism. Next day, laboratory test showed that blood potassium was 3.0 mmol/L. He was given potassium chloride sustained-release tablets 1 g orally thrice daily. Six days later, the patient complained of a rapid heartbeat after slight activity. Laboratory tests showed that blood potassium was 3.3 mmol/L and a potassium magnesium aspartate tablet was administered orally thrice daily. After 8 days of potassium supplementation treatments, the patient's blood potassium level was 3.5 mmol/L, while the blood pressure increased to 163/90 mmHg. Losartan potassium 50 mg once daily was given orally.  Clinical pharmacist consulted and learned that the patient continued to take his own LT4 75 μg once daily while following the doctor's instructions to take LT4 50 μg once daily. The patient was instructed to immediately stop taking his own medication and the LT4 dose was adjusted to 75 μg once daily. Thirteen days later, the patient's serum potassium returned to 4.0 mmol/L and no further discomfort occurred.
  • ADR监测
    . 1999, 1(2): 106-107.
    本文介绍我院自1996年成立ADR监测小组以来,在制定并实施ADR监测报告制度,做好ADR报告的收集、整理、评估、归档等方面所做的一系列监测工作,并如实地阐明了存在的一些问题以及开展ADR监测工作的体会与建议,为我国在县(市)级医院开展ADR监测工作进行了有益的尝试。
  • 不良事件
    . 2005, 7(2): 144-144.
  • 病例报告
    . 2000, 2(2): 126-127.
  • 病例报告
    . 2003, 5(6): 406-407.
  • 病例报告
    Jin Zhenbo
    . 2009, 11(3): 211-2.
    A 36-year-old woman with hyperthyroidism was given thiamazole 10 mg thrice daily and propranolol 10 mg thrice daily. Twentythree days later, the patient presented with skin rash, loss of appetite, and nausea. Laboratory test revealed the following levels: WBC count 1.6×109/L, absolute neutrophil count 0.80×109/L, ALT 125.0 U/L, and AST 62.0 U/L. Thiamazole was withdrawn. After treatment with reduced glutathione, silibinin, loratadine, and filgrastim, the patient improved. Her WBC count was 4.30×109/L, her absolute neutrophil count was 3.1×109/L, and her ALT and AST levels were 27.0 U/L and 17.0 U/L, respectively.
  • 病例报告
    Xie Fujun;Chen Yanqiu
    . 2009, 11(1): 50-2.
    A 55yearold man, who had a 2year history of type 2 diabetes and 4year history of hypertension, treated with repaglinide 2 mg thrice daily, acarbose 50 mg thrice daily, diformin 500 mg thrice daily, sustainedrelease nifedipine 30 mg once daily, and fosinopril 10 mg once daily. Rosiglitazone 4 mg once daily was added to his regimen and repaglinide was increased from 2 mg thrice daily to 3 mg thrice daily due to poor control of his blood glucose. After one week of treatment, he developed epidermal sclerosis, dehiscence, and excoriation with pain on his palms and soles. Exfoliative keratolysis was diagnosed. Exfoliative kerotolysis was considered to be rosiglitazoneassociated. Rosiglitazone was withdrawn and other drugs were continuous. The patient was given vitamin C and vitamin B complex. His excoriation improved 3 days later, and the condition of his skin normalized 3 weeks later.
  • 病例报告
    Liu Jianhong;Zhang Yujin;Xun Yifei;Ding Wen;Yuan Yuqin;Hong Xiaoxi;Guo Lixia;Ding Haiyan
    . 2008, 10(4): 0-0.

    A 48yearold woman who had a history of penicilin hypersensitivity was administered with an IV infusion of levofloxacin 0.2 g for upper respiratory infection. After 2 minutes of this infusion, the woman developed dizziness, nausea and vomiting. Subsequently unconsciousness and cardiorespiratory arrest occurred. She was given cardiopulmonary resuscitation and IV dexamethasone 10 mg immediately. Thirty seconds later, her breath and heartbeat recovered. Thirty minutes later, her respiration, heart rate, and blood pressure returned to normal limits. The medication was switched to azithromycin and the similar reactions did not reappear.

  • 病例报告
    . 2006, 8(6): 441-441.
  • 病例报告
    . 2007, 9(2): 90-90.
  • 中药不良反应
    . 2007, 9(1): 59-60.
  • 中药不良反应
    SU Lian-ming;AI Jiang;KONG Xiang-hong
    . 2012, 14(1): 61-3.

    A 30-year-old female patient with psoriasis took Keyin Wan 10 g twice daily for one month by herself. After drug withdrawal, asthenia, yellowish skin and sclera, anorexia, and dark urine appeared in the patient. Laboratory tests showed the following values: alanine aminotransferase (ALT)196 U/L, aspartate aminotransferase (AST)133 U/L, gamma-glutamyltransferase (γ-GT)59 U/L, total bilirubin (TBil)577.7 μmol/L, direct bilirubin (DBil)392.5 μmol/L, and indirect bilirubin (IBil)185.2 μmol/L. She was treated with glucurolactone, polyene phosphatidyl choline, ademetionine, and other symptomatic therapy for 15 days, and then her symptoms improved gradually and liver function tests revealed an ALT level of 56 U/L, an AST level of 62 U/L, a γ-GT level of 42 U/L, a TBil level of 96.7 μmol/L, a DBil level of 56.4 μmol/L, and a IBil level of 68.8 μmol/L.

  • Cai Haodong, Wang Yuqin
    Adverse Drug Reactions Journal. 2020, 22(6): 329-332. https://doi.org/10.3760/cma.j.cn114015-20200519-00549
    Facing the unprecedented epidemic situation of novel coronavirus pneumonia (COVID-19), medical workers in China have not only successfully controlled the spread of the epidemic in Chinese mainland in just 4 months, but also have made great achievements in scientific research on COVID-19. In the past 4 months, a total of 1-033 English papers about COVID-19 written by Chinese scholars have been published and included in PubMed database, which is 6.6 times the number of articles published in 2003. The proportion of papers published by authors in Chinese mainland has increased from 48.7% (76/156) during the SARS epidemic in 2003 to 84.8% (876/1-033) with 4 months in 2020. The papers were also published significantly earlier than before. Chinese researchers identified the novel coronavirus that caused the outbreak less than 1 month after the COVID-19 outbreak (on January 7, 2020) and reported it to the WHO. They also published articles on the genetic sequence and transmission dynamics of the virus and clinical characteristics of COVID-19 patients in that month. China pays more attention to drug safety of patients. The proportion of English and Chinese literature published by pharmaceutical authors increased from 0 and 0.2% (10/4-023) in 2003 to 2.3% (24/1-032) and 9.3% (215/2-317) from January to April in 2020, respectively. China has not only become a model for the world in epidemic control, but also made important contributions to the relevant academic research.
  • Wang Chunhua1,2, Hu Xiao2, Yang Cuicui2, Hu Chaoying2, Zhang Lan1,2
    Adverse Drug Reactions Journal. 2019, 21(1): 30-35. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.006
    Phase I clinical trial is a preliminary clinical pharmacology and human safety evaluation test of investigational products and used to observe the tolerance of human body to investigational products and obtain pharmacokinetic data in human body. The lack of clinical safety data of investigational products makes it difficult to judge the causality of adverse events (AE) in trials. There is no uniform criteria for causality assessment. Hill criterion is more widely used at present. There are 3 methods to assess the causality between investigational products and AE: expert judgment, algorithms, and probabilistic approaches. The major method for causality assessment of AE used in China, which is similar to the expert judgment method, is basically consistent with that in the World Health Organization′s Uppsala Monitoring Center (UMC). However, these evaluation methods are more suitable for post-marketing drug evaluation than for phase I clinical trials. With the join of our country in the International Conference on Harmonisation(ICH), Phase I clinical trials have gradually increased. Related evaluation guidelines should be published and an AE database should be established in China, basing on the metabolic and pharmacodynamic characteristics of the investigational products (including data from the preclinical studies) and the clinical manifestations of the subjects, and referring to the Hill criteria commonly used in the world, to conduct phase I clinical trials well on the premise of guaranteeing the safety of the subjects and provide more valuable and accurate information for the following studies of investigational products at home and abroad.
  • 病例报告
    Guo Haiping;Zhou Wenyan;Cui Shuping;Li Sa;Tong Qiuyan
    . 2014, 16(4): 247-1.
    A 59-year-old male patient received regularly aspirin, clopidogrel, etc. by mouth after operation for coronary angiography, balloon dilatation, and coronary stent implanting. Two months later, the patient developed multiple and superficial oral ulcer on his tongue and oral mucosa. The patient stopped clopidogrel medication by himself and other drugs were continued. The oral ulcer alleviated gradually and disappeared one month later. The oral ulcer recurred when the patient received clopidogrel for 2 months again and healed after the clopidogrel withdrawal.
  • 论著
    Sun Xiangju;Wu Yubo;Jiang Aihua;Xu Na;Liang Jing;Wu Yumeng
    . 2014, 16(6): 345-5.
    ObjectiveTo analyze and compare the prothetic effects of reduced glutathione and polyene phosphatidyl choline on liver injury evoked by cyclophosphamide in mice.MethodsForty Kunming mice were divided into the liver injury model group, the reduced glutathione group, the polyene phosphatidyl choline group, and the control group by simple random sampling. Each group comprised 10 mice. The mice in the fornamed 3 groups received intraperitoneal injection of cyclophosphamide (100 mg·kg11·d11) to evoke the liver injury on day 1 to 4 of the experiment and 0.9% sodium chloride solution 0.2 ml, reduced glutathione 180 mg· kg11· d11, and polyene phosphatidyl choline 90 mg·kg11·d11 were given respectively in the 3 groups on day 5 to 14 of the experiment. The mice in the control group received intraperitoneal injection of same volume of 0.9% sodium chloride solution on day 1 to 14 of experiment. The body weight of mice in the 4 groups were measured on the first day before intraperitoneal injection of cyclophosphamide and the fifteenth day of the experiment. The mice in the 4 groups were executed on the fifteenth day of the experiment. The blood samples were taken from eye pit before the mice were killed and the serum total bilirubin and glutathione levels were measured. Their liver tissue were taken and weighed, and the liver coefficient were calculated. The liver tissue were taken and the activities of alanine aminotransferase (ALT), aspartate aminotransferase (AST), superoxide dismutase (SOD), catalase (CAT) and the level of malonaldehyde (MDA) in the liver tissue were measured. The morphological changes in the liver tissue in the 4 groups were observed.ResultsOn day 15 of experi1ment, the body weights in mice in the liver injury model group, the reduced glutathione group, and the polyene phosphatidyl choline group were lower significantly than those in the control group (P<0.01 or P<0.05). The body weights in mice in the reduced glutathione group were higher than those in the liver injury model group (P<0.05). The liver coefficient in mice in the liver injury model group (5.74%±0.11%) was higher than that in the control group (4.68%±0.37%) and the reduced glutathione group (4.81%±0.19%) (all P<0.01). The liver coefficient in mice in the polyene phosphatidyl choline group (5.25%±0.35%) was higher than that in the control group(P<0.05). The levels of serum total bilirubin in the liver injury model group, the reduced glutathione group, and the polyene phosphatidyl choline group [(129.8±1.9), (110.9±1.3), and (125.7±2.6) μmol/L] were higher than those in the control group [(100.8±3.0) μmol/L] (all P<0.01). The level of serum total bilirubin in mice in the reduced glutathione group was lower than that in the liver injury model group (P<0.01). The levels of serum glutathione in mice in the liver injury model group and the polyene phosphatidyl choline group [(50.5±1.9) and (55.9±2.4) g/L] were lower than those in the control group and the reduced glutathione group [(73.8±4.3) and (71.3±3.7) g/L](all P<0.01). The activities of AST, ALT, SOD, and CAT in the liver tissue in mice in the liver injury model group, the reduced glutathione group, and the polyene phosphatidyl choline group were lower than those in the control group [(144.5±7.9),(223.1±15.1),(173.9±5.3)U/mg vs. (332.6±7.3)U/mg], [(50.5±4.0),(108.0±8.0), (62.3±2.0)U/mg vs. (139.6±7.0)U/mg], [(99.0±9.7), (165.0±114.6), (115.6±7.3)U/mg vs. (207.6±8.3)U/mg], [(35.4±1.0), (39.3±1.1), (36.3±1.2)U/mg vs. (42.5±2.3)U/mg] (all P<0.01). The MDA levels in the liver injury model group, the reduced glutathione group, and the polyene phosphatidyl choline group were higher than those in the control group[(23.4±2.6), (16.3±1.5), (20.2±1.9)nmol/mg vs. (10.2±2.2)nmol/mg] (all P<0.01). But the levels of above1mentioned four enzymes in the reduced glutathione group were higher than those in the polyene phosphatidyl choline group and the liver injury model group (P<0.01 or P<0.05), the levels of MDA were lower than those in the polyene phosphatidyl choline and the liver injury model groups (all P<0.05). There were many necrotic foci and inflammatory corpuscles in hepatic tissue in mice in the liver injury model group, the structure of hepatocyte was inordinate. The structure of most hepatocytes in the reduced glutathione group was normal, only few necrotic foci were seen. Part of the hepatocytes in the polyene phosphatidyl choline group showed gap increase, swelling, and a few necrotic foci. ConclusionsReduced glutathione has significant repairing effects on liver injury in mice evoked by cyclophosphamide. Polyene phosphatidyl choline can only increase the ALT activity in the model of liver injury evoked by cyclophosphamide in mice.
  • Kong Xiangling, Tian Meilei, Hao Yugui
    Adverse Drug Reactions Journal. 2020, 22(7): 436-437. https://doi.org/10.3760/cma.j.cn114015-20190402-00304
    A 69-year-old male patient was given pituitrin 24 U dissolved in 0.9% sodium injection for continuous intravenous pump once per 12-hours for alcoholic cirrhosis complicated by upper gastrointestinal hemorrhage. At the same time, omeprazole, octreotide, hemocoagulase, plasma, and symptomatic and supportive treatments were given conventionally. On the second day, the patient developed tongue swelling. Considering that it might be related to therapeutic drugs, intravenous injection of dexamethasone 5-mg and intramuscular injection of promethazine 25-mg were given. Due to the improvement of bleeding symptoms, pituitrin was stopped and other drugs continued to be used. Eight days later, black stool recurred in the patient and pituitrin was given again. The next day, the patient had tongue swelling again, which was improved after the same treatments. The patient′s tongue swelling was considered as angioedema caused by pituitrin.
  • 病例报告
    LIANG Yuan;YANG Na;WANG Xian-ling;DOU Jing-tao;DU Jin;LÜZhao-hui;MU Yi-ming
    . 2012, 14(2): 113-3.

    Three female patients (aged 65, 61, and 51 years, respectively) with anterior pituitary hypofunction received an infusion of hydrocortisone 100 mg once daily, they developed mental symptoms such as excitation, delusion, hallucination 24-72 hours after starting therapy. The dosage of hydrocortisone was gradually decreased and then the drug was discontinued. Four to five days after drug withdrawal, the mental symptoms subsided.

  • 病例报告
    WU Xiao-li;GAO Le-hong;SONG Hai-qing;WANG Yu-ping;ZHAN Shu-qin
    . 2013, 15(1): 46-2.
    Two patients with chronic hepatitis B developed limb pain and asthenia after receiving adefovir dipivoxil (ADV) 10 mg/d. Patient 1 were male aged 58, patient 2 were female aged 55. Laboratory tests revealed that serum phosphorus levels in patients 1 and 2 were 0.71 and 0.58 mmol/L, respectively; 24-hour urinary phosphorus levels in patients 1 and 2 were 6.82 and 4.57 mmol/24 h, respectively. Joint X-ray showed osteoporosis; a bone scan revealed increased radiotracer uptake. The 2 patients were diagnosed with hypophosphatemic bone disease. Electromyography showed peripheral nerve damage in patient 1 and he was considered to have hypophosphatemic bone disease complicated with peripheral neuropathy. Adefovir dipivoxil was continued, supplementary phosphate and phosphorus-rich foods were given, their symptoms improved.
  • 病例报告
    CAI Ran;LIU Xiao-meng
    . 2013, 15(2): 93-2.
    碘克沙醇; 急性肾损伤
  • . 2013, 15(3): 177-3.
  • 中毒救治
    Xu Jing;Zhu Weiguo;Wang Dixin
    . 2009, 11(1): 35-2.
    The traditional Chinese medicine Xiaoerqizhen pills, which contain realgar and cinnabar, are used for treatment of acute infantile convulsion and constipation. This paper reports that two adults developed chronic arsenic poisoning after prolonged use of highdose Xiaoerqizhen pills.Patient 1, a 36yearold woman, received 40~80 Xiaoerqizhen pills once daily for three years for constipation. Two to three months after starting Xiaoerqizhen pills use, she developed fatigue, anorexia, and dark skin pigmentation on her abdomen. In recent one year, she developed dizziness, headache, insomnia, and numbness of her limb ends. After admission, an examination showed pigmentation on his face, trunk, and extremities, pachyderma on palms and soles. Her blood arsenic level was 7.3 μg/L, and her urine arsenic level was 0.117 mg/L. Chronic arsenic poisoning was diagnosed. After completing three courses of therapy with sodium dimercaptopropane sulfonate, her symptoms markedly improved.Patient 2, a 40yearold man, received 20~80 Xiaoerqizhen pills one to two times daily for 7 years for constipation. During the treatment, he gradually presented with fatigue, anorexia, nausea, abdominal distension, pigmentation over his entire body, severe keratodermia, and numbness of extremities, hepatoemegaly, splenomegaly, and anemia. His urine arsenic level was 4.28 mg/L. He was diagnosed with chronic arsenic poisoning. After completing five courses of therapy with sodium dimercaptopropane sulfonate, his symptoms were markedly improved and he was discharged.
  • 临床观察
    Wang Lina;Qi Xiaolianb;Gao Rana
    . 2009, 11(1): 23-5.
    Objective: To observe the safety of prolonged treatment with high blood phenobarbital concentration for acute encephalitis with refractory, repetitive partial seizures (AERRPS). Methods: Between July 2003 and September 2008 the inpatients with encephalitis, who met the Sakuma diagnostic criteria for AERRPS in 2001, were enrolled in this study. The dosage and administration were as follows: an intravenous or intramuscular injection of phenobarbital 200 mg, followed by an IV infusion of 1~1.5 mg/(kg·h) or an intramuscular or intravenous injection of 200 mg every 2~4 hours. The total daily dosage was 1.2~2.4 g. The blood phenobarbital concentration reached 100 μg/ml in about 24 hours. The high blood phenobarbital concentration was maintained for 24~100 days. During the treatment with high blood phenobarbital concentration, the patients’blood pressure, heart rate, heart rhythm, respiration, skin disorders, consciousness, pupils, and seizures were observed. The routine blood test and biochemical analysis were performed. Prolonged EEG monitoring was conducted. The observation on outcome was at least 6 months. Results: During the treatment with high blood phenobarbital concentration, 5 patients were in coma status, the Glasgow coma scales were scored 3~5. No burstdepression pattern was found under an EEG monitoring. Most of brain stem reflexes remained and spontaneously breathing disappeared. Three cases of sinus tachycardia, 2 cases of ventricular tachycardia or supraventricular tachycardia occurred. Two patients' blood pressure decreased to 64~84/40~55 mmHg. Five patients’ALT, AST, and γGT levels were 57~385 IU/L, 38~365 IU /L, and 54~542 IU /L, respectively. The blood ammonia level increased to 103.7 μmol/L. The severity of skin dosorders was mild. Renal function was not affected by the treatment. When blood phenobarbital concentration decrased to < 50 μg/ml, the patients’consciousness and spontaneous breathing recovered, and adverse reactions were basically disappeared. Conclusion: Prolonged treatment with high blood phenobarbital concentration may cause severe adverse reactions. Therefore, the patients with AERRPS receiving prolonged treatment with high blood phenobarbital concentration should be given artificial ventilation and close monitoring, and the adverse reactions should be managed immediately in order to benefit the patient safety.
  • 安全信息
    . 2009, 11(2): 148-1.
  • 病例报告
    Zhou Mina;Huang Jina;Liu Jingb;Duan Lianningb;Yan Hongminb;Qiao Aizhenb
    . 2009, 11(2): 137-2.
    A 17yearold girl was treated with oral tacrolimus 2 mg in the morning and 3 mg in the evening for acute lymphocytic leukemia; the combined drugs included famotidine injection, micafungin injection, and azithromycin sodium chloride injection. After 30 days of treatment, the patient developed prolonged sleeping time, reduced speech, and slowed responses, and then progressed gradually to lethargy, decreased memory, visual hallucination, slowed speech, and incorrect calculation, and so on. The neurological disorder was considered to be possibly tacrolimus plus azithromycinassociated. Tacrolimus was discontinued. Two days later, his symptoms relieved.
  • 病例报告
    . 2003, 5(3): 212-212.
  • Zhou Mingfang, Wang Wenjing, Jiang Hongli, Wang Fuchuan, Yi Wei
    Adverse Drug Reactions Journal. 2023, 25(1): 28-33. https://doi.org/10.3760/cma.j.cn114015-20220427-00372
    Objective To explore the effect of tenofovir disoproxil fumarate (TDF) treatment on renal function for preventing mother-to-infant transmission of hepatitis B virus (HBV) in pregnant women during the second and third trimester of pregnancy. Methods The subjects were selected from pregnant women with HBV infection who were registered in Department of Gynecology and Obstetrics, Beijing Ditan Hospital, Capital Medical University and delivered between January and December 2021. The pregnant women who had HBV DNA ≥2.0×105 IU/ml and took TDF at 24-28 weeks of gestation were included in treatment group, and the pregnant women who had HBV DNA <2.0×105 IU/ml and did not use anti-HBV drugs during pregnancy were included in control group. The medical records data of pregnant women in the 2 groups were collected, including urine routine examination, liver function, renal function, estimated glomerular filtration rate (eGFR), blood phosphorus, serum markers of hepatitis B, HBV DNA, ect. at 24-28 weeks of gestation (baseline data), renal function, eGFR, serum phosphorus at 36-37 weeks of gestation, delivery, and 42 days postpartum, and adverse events related to renal tubular injury. Serum creatinine (Scr), blood urea nitrogen, eGFR, and blood phosphorus at baseline level, 36-37 weeks, delivery and 42 days postpartum, and changes of Scr and blood phosphorus before and after treatment between the 2 groups were compared, and adverse events related to renal tubular injury in the treatment group were recorded. Results A total of 189 pregnant women were entered in the analysis, including 106 in the treatment group and 83 in the control group. The differences in age, proportion of primipara, baseline level of alanine aminotransferase, Scr, blood urea nitrogen, eGFR and blood phosphorus between the 2 groups were not statistically significant (all P>0.05), but the proportion of HBeAg-positive women and HBV DNA level in the treatment group were significantly higher than those in the control group (all P<0.05). The differences in Scr, blood urea nitrogen, eGFR, and blood phosphorus between the treatment group and the control group at 36-37 weeks of gestation, delivery and 42 days postpartum were not statistically significant (all P>0.05). The trends of changes in Scr, blood urea nitrogen, eGFR, and blood phosphorus from baseline level to 42 days postpartum were similar between 2 groups (all P>0.05). None of the pregnant women in the treatment group had adverse events related to renal tubular injury, such as hypophosphatemia, elevated Scr, renal hypouricemia, β2-microglobulinuria, non-diabetic glycosuria, metabolic acidosis, etc. Conclusion TDF is safe for the kidney in the second and third trimester of pregnancy to strengthen the blocking of mother-to-infant  transmission of HBV.
  • Zhao Na, Liu Wei, Chu Yanqi
    Adverse Drug Reactions Journal. 2024, 26(3): 188-190. https://doi.org/10.3760/cma.j.cn114015-20230613-00429
    An 87-year-old female patient with Alzheimer's disease received donepezil 5-mg once daily orally for 8 years and then memantine 10-mg once daily orally was added due to the progression of the condition. Three months later, the patient suddenly fell into a coma and did not respond to call, acompanied by shortness of breath and wheezing. The patient had needle like changes in the pupils of both eyes, with blood pressure 190/100-mmHg and heart rate 56 beats per minute.  The Glasgow Coma Scale (GCS) was E1V1M1. It was considered that the patient was poisoned due to drug accumulation caused by combination use of donepezil and memantine (blood concentration of methotrexate 215-mg/L, warning value: 30-mg/L; blood concentration of donepezil 33-mg/L, warning value: 20-mg/L). The 2 drugs were stopped, and symptomatic and supportive treatments such as fluid hydration, blood pressure reduction, and brain awakening were given. On the 3th day after drug discontinuation, the patient′s consciousness temporarily shifted to drowsiness, and her GCS was E1V1M1; on the 7th day after drug discontinuation, the patient′s consciousness became clear and she was able to answer simple questions, with GCS E4V4M4, blood pressure 126/67-mmHg, and normal pupil size.
  • 综合报道
    . 2002, 4(3): 166-168.
    本文简要综合报道药物引起的颅内压增高症,并初步探讨药源性颅内压增高的机理、临床意义及防治,以供临床参考。
  • 综合报道
    . 2002, 4(1): 26-28.
    膦甲酸是一种广谱抗病毒药物,可有效治疗巨细胞病毒(CMV)、单纯疱疹病毒感染和人类免疫缺陷病毒感染。研究表明,应用膦甲酸治疗期间可发生电解质紊乱、酸中毒、贫血、发热、呕吐等副作用,膦甲酸的肾毒性主要有以下表现:引起急性肾功能衰竭(病理改变表现为肾小球新月体形成、肾小管性间质性肾炎)、肾小管性酸中毒、肾小管性尿崩症等。
  • 病例报告
    . 2005, 7(3): 174-174.
  • 不良事件
    . 2005, 7(4): 307-307.
  • 论著
    Liang Hongwei;Sun Li;Shen Liyang;Deng Yanping
    . 2008, 10(3): 153-5.

    Objective: To analyze the hepatorenal damage and risk factors in moderate heroindependent patients. Methods: The moderate heroindependent patients who abused heroin<2.0 g/d in the last week and whose scores of the abstinence syndrome were 65~140 entered the study. The liver function indices in 1 455 cases, renal function indices in 1 407 cases, and risk factors were analysed retrospectively. Results: The percentages of abnormal ALT, AST, TBil, BUN, and Cr levels were 45.43%, 38.63%, 17.11%, 6.25%, and 4.12%, respectively. Multivariate Logistic regression analysis showed that risk factors for abnormal ALT were sex, duration and route of drug abuse (OR was 0.653, 1.150, and 2.263, respectively); and risk factors for abnormal AST were sex and route of drug abuse (OR was 0.692 and 2.447, respectively). Conclusion: The severity of liver damage is higher than that of renal damage in moderate heroin-dependent patients. The risk for abnormal ALT is higher in the patients with a longer term of abuse. The risk for abnormal ALT and AST in male patients and intravenous route administration is higher than in female and other route of administration .

  • 安全用药
    . 2002, 4(4): 231-233.
    目的:探讨小剂量脂溶性β-阻滞剂—美托洛尔(美多心安)在治疗老年恶化劳力型心绞痛中的安全性。方法:观察在治疗老年恶化劳力型心绞痛时,美托洛尔对心脏起搏及传导系统及心脏外系统的毒副作用。结果:美托洛尔能有效控制老年恶化劳力型心绞痛的发作,严重心动过缓、房室传导阻滞少见,且与年龄及联合应用钙拮抗剂有关,无窦性停搏和Ⅱ°Ⅱ型以上房室传导阻滞发生,药物的心外系统副作用发生率低。结论:依照小剂量起始、逐渐加量的原则,美托洛尔可安全、有效、迅速地控制老年恶化劳力型心绞痛发作,其心内、心外副作用发生率低。对于80岁以上的高龄或合用钙拮抗剂的患者,该药加量时应该更加慎重。
  • 病例报告
    Wu Shuyun;Hou Zhiwen;Li Yan
    . 2008, 10(5): 0-0.

    A 30-year-old pregnant woman was hospitalized with chronic hepatitis B. After treatment with liverprotective medications, her liver function improved. In order to reduce transaminase levels further, bifendate 15 mg thrice daily was added to her regimen. Two weeks later, her liver function worsened. Laboratory investigations revealed the following: ALT 24.9 U/L,AST 328.9 U/L,TBil 32.0 μmol/L,DBil 20 μmol/L. The bifendate was stopped, and other liverprotective medications were continued. Her liver function returned to normal limits.

  • 病例报告
    . 2006, 8(6): 449-450.
  • 调查研究
    Huang Yu;Song Youhua;Tang Guang;Zhang Shige;Zhang Lifang;Gong Lianbing;Shang Shulan
    . 2000, 2(4): 221-225.
    Objective: To investigate the use of sedatives and hypnotics in Beijing. Methods: 10877 Beijng citizens were enrolled in our study by questionaire or interview for statistic analysis of the above medicine utilization. Results: The findings showed the rate of sedatives and hypnotics taken increased with age, and that the different effects appeared at different ages. Conclusion: The management of sedatives and hypnotics in institutions of health services and publictiy of the safety of administration cannot be overemphasized in order to avoid their abuse and get the better outcomes.
  • . 2013, 15(4): 181-2.
  • 病例报告
    Wang Zhiqing
    . 2010, 12(4): 284-3.
    Two patients (a woman aged 76 years and a man aged 56 years ) with uremia undergoing hemodialysis received an IV infusion of cefepime 1 g every 12 hours for respiratory tract infections, respectively. The woman developed listlessness, unresponsiveness, agitation, followed by agnosia and aphasia on day 5 of treatment, and ECG revealed diffuse slow waves. The man presented with nausea, vomiting, agitation, myocolonia, dysphasia, unresponsiveness, and mental confusion on day 3 of treatment. In addition, brain CT showed no marked change in both patients. Neurological adverse reactions were considered to be related to cefepime. Therefore,cefepime was discontinued and hemodialysis was continued. Subsequently, neurological and mental adverse reactions disappeared and both patients were discharged.
  • 实验论著
    Wu Bin;Cao Min;Liu Shumin;Jin Yong;Wang Yu
    . 2010, 12(6): 381-6.

    Objective: To observe the effects of different concentrations of water extracts of cocklebur fruit on liver function and morphology in rats, in order to provide experimental evidence for safe use of cocklebur fruit in clinical practice. Methods: Twentytwo kilogram of ground cocklebur fruit was extracted with 65% alcohol. The alcohol extractions was extracted with petroleum ether, ethyl acetate and nbutanol in turn. The organic solvents were retrieved. Seven hundred and fortythree point six gram of water extracts of cocklebur fruit was obtained. The water extracts was mixed with normal saline solution containing 3% Tween80, and two different concentrations of suspensions (28.00 mg/mL and 1.12 mg/mL) was prepared. One hundred and fortyfour SPF SD male rats, weighing (200±10)g, were divided into the highdose group, the lowdose group and the control group by randomdigit table method, each group comprised 48 rats. The 2.5mL of 28.00 g/mL suspension and 2.5mL of 1.12 g/mL suspension were perfused into the rats’stomach in the high-dose and the low-dose groups twice daily, respectively. The rats in the control group was perfused with same volume of normal saline solution containing 3% Tween80 twice daily. The duration of gavage feeding was 28 days. The appearance, intake of food, and activities of rats were observed. The body weight of the rats were weighed, the serum levels of ALT, AST and AKP were measured 7, 14, 21, and 28 days after drug initiation and 7, 14 days after drug withdrawal, respectively. Subsequently, the rats were sacrificed, the liver index was calculated(liver weight/body weight×100%) and the liver histopathology was scored and graded. Results: During a 28day period of medication, the rats in the highdose group developed erect hair, epilation, lassitude, anorexia, and were unresponsive to stimuli. Only a few rats in the lowdose group developed lassitude and listlessness. Fourteen days after drug withdrawal, the rats’activities and intake of food were increased, degree of lassitude improved and the gloss of coat normalized in the highdose group. Twentyone and 28 days after drug initiation and 7 days after drug withdrawal, the body weight of rats in the highdose group[(10.5±4.2),(10.2±3.1),(12.1±4.5) g] were markedly lower than those in the lowdose group[(15.3±2.10), (16.7±4.2), (17.6±3.2) g\] and the control group[(18.6±3.4), (20.5±5.2), (19.6±2.5)g],the serum levels of ALT[(42.8±3.2), (49.3±5.9), (43.2±3.2)U/L], AST[(108.8±11.7), (119.8±16.3), 110.5±17.6)U/L] were markedly higher than those in the lowdose group [(33.7±4.6), (34.8±5.4), ( 33.5±4.9)U/L,(94.7±12.6), (95.4±10.7), (96.8±12.8)U/L]and the control group[(31.2±4.3), (32.5±6.3), (31.7±5.7)U/L, (92.3±16.2), (92.9±20.3), (93.7±16.3)U/L], the serum levels of AKP [(197.2±25.7), (210.4±41.8), (189.3+17.6)U/L] were markedly higher than those in the lowdose group [(174.3±22.6), (175.3±27.4), (176.3±22.8)U/L]and the control group [(171.3±25.6), (172.5±28.7), (172.8±26.3)U/L].Twentyone and 28 days after drug initiation and 7 days after withdrawal, the liver indexes in the highdose group(4.2±0.4, 5.0±0.7, 4.9±0.3)were markedly higher than those in the lowdose group and the control group[(3.4±0.6, 3.6±0.6, 3.9±0.6), (3.0±0.4, 3.2±0.3, 3.4±0.5)]. Fourteen, 21 and 28 days after drug initiation and 7 days after drug withdrawal, the median score of liver pathology in the highdose group (1.0, 1.5, 3.0, 1.5) were markedly higher than those in the lowdose group (0.2, 0.5, 0.8, 0.5) and the control group(0.1, 0.1, 0.2, 0.1). The differences of each index mentioned above between the highdose group and the lowdose group as well as the control group were statistically significant(P<0.05, P<0.01) , but the differences between the lowdose group and the control group were no statistically significant(P>0.05). Conclusion: The rat’s liver damage due to the water extract of cocklebur fruit is related to its dosage and duration of drug use; highdose and prolonged use may increase liver damage.

  • 实验论著
    Feng Tongfu;Wang Qi;Zhang Wei;Li Danrong;Li Li
    . 2010, 12(6): 387-6.

    Objective: To screen carboplatinresistant human ovarian cancerrelated protein in order to explore the molecular mechanism of resistance at the protein level. Methods: The total proteins of parental (SKOV3) and carboplatinresistant (SKOV3/CB) cell lines derived from human ovarian cancer were extracted, the differentially expressed proteins were separated and screened by twodimensional liquid chromatography. The proteins were identified by electrospray ionizationtandem mass spectrometry (ESIMS/MS). Results: A total of 54 differentially expressed proteins were isolated and screened. Of these proteins, the expression of 20 proteins were upregulated in SKOV3 cell line and the expression of 34 proteins were upregulated in SKOV3/CB cell line. Four proteins whose expression were upregulated in SKOV3/CB cell line associated with carboplatin resistance were identified, including superoxide dismutase, cyclindependent kinase 6 inhibitor, transcriptional adapter 1 protein,and proapoptotic caspase adapter protein. These proteins were associated with oxidation and reduction,cell cycle control,apoptosis and others. Conclusion: The mechanism of carboplatin resistance in the human ovarian cancer may be related to different kinds of proteins; and these experimental data will be valuable for further study of platinum resistance in the human ovarian cancer.

  • 病例报告
    Zhang Jing;Wang Ting;Guo Xiaofang;Qiao Jianfeng
    . 2014, 16(4): 249-2.
    A 78-year-old female patient with myocardial infarction received oral aspirin 100 mg once daily and clopidogrel hydrogen sulfate 75 mg once daily. She developed pruritus and erythema on her abdomen and both lower extremities in the next morning. The clopidogrel hydrogen sulfate was discontinued and she was treated with loratadine 10 mg once daily. Her pruritus had improved and erythema had subsided after 2 hours. On day 2, the patient self-administered clopidogrel hydrogen sulfate 75 mg. She presented with anaphylactoid symptoms again and loratadine was continued. Four days later, the patient underwent coronary angiography and percutaneous coronary intervention. She received dual antiplatelet therapy with oral ticagrelor 90 mg twice daily and aspirin 100 mg once daily after surgery. The patient had no discomfort at 6 months follow-up.
  • Liu Zhisheng, Li Xingli, He Jianmei, Wei Xiuqing, Zheng Jun, Zhao Junshi, Chen Xi
    . 2016, 18(2): 105.
    ObjectiveTo explore the occurrence of adverse reactions  and its influencing factors in the teenagers aged 12 to 24 years who received 1 year or more longer antiviral therapy.MethodsNational Information System for AIDS Control and Prevention was searched and the data of teenagers and young adults aged 12 to 24 years with HIV/AIDS treated in Hunan Province from October 1, 2003 to October 31, 2013 were collected. The information included sex, age,  marital status, route of infection, interval between diagnosis and treatment, with or without symptoms and signs at the beginning of treatment, opportunistic infection, clinical stages, counts of peripheral blood CD4+T lymphocytes (CD4 cells), initial treatment plan, and the type and incidence rate of adverse reactions in each month during the first year of treatment. The related factors between antiviral therapy and the adverse reactions were analyzed by Logistic regression model.ResultsA total of 559 patients were enrolled into this study. Of them, 312 were males and 247 were females with the average age (22±2) years. The route of infection was sexual transmission accounting for 90.9%  (508/559). The number of cases with peripheral blood CD4 cell count ≥200 accounted for 55.1% (300/544).The singles accounted for 65.5% (366/559). The interval between diagnosis and treatment was from 0 to 1 859 days and an average time was 198 days, median time was 53 days. At the beginning of treatment , the number of cases with symptoms and signs accounted for 29.7% (166/559), associated opportunistic infections accounted for 28.8% (169/589), and the clinical stages of  Ⅰ,Ⅱ,Ⅲ, and Ⅳ accounted for 266 (50.5%), 124 (23.5%), 99 (18.8%), and 38 (7.2%), respectively. The initial treatment plans for the patients of male, female, 12-18 years, and 19-24 years were mainly lamivudine+zidovudime+nevirapine,  they accounted for 45.2% (141/312), 37.2% (92/247), 45.9% (45/98), and 40.8% (188/461), respectively. The incidence of adverse reactions in the first month during the treatment was the highest which accounted for 19.3% (108/559), including nausea and vomitting (37.0%, 40/108), erythema (34.3%, 37/108), and fatigue (28.7%, 31/108). The incidence of adverse reactions in the second month during the treatment was 11.7% (57/486), including erythema (35.1%, 20/57), fatigue (26.3%, 15/57) and appetite changes (24.6%,14/57). thereafter, the incidences of adverse reactions of each month were lower than 10.0%. The results of single factor analysis for correlative factors of adverse reactions in the first month during the treatment  showed age, sex, route of infection, with or without symptoms and signs at the beginning of treatment, with or without opportunistic infection, clinical stages and number of CD4 cells were related to the adverse reactions (all P<0.05 ). The result of multi factor Logistic regression analysis showed age 19-24 years old (OR=1.782, 95%CI: 1.293-3.554, P=0.002), female (OR=1.904, 95%CI: 1.204-3.013, P=0.006), with symptoms and signs at the beginning of treatment (OR=3.025, 95%CI:1.902-4.810, P=0.000) were the risk factors of the adverse reactions.ConclusionsThe mail adverse reactions of antiviral therapy in patients aged 12-24 years during the first year′s treatment were  gastrointestinal reaction and skin lesions. The incidence of the adverse reactions in the first month during the treatment was the highest. Age 19-24 years, female, and with symptoms and signs at the beginning of treatment are the the risk factors of the adverse reactions.
  • 用药错误
    Zhang Mengmeng;Zhang Ting;Wang Shuang;Zhao Juan;Zhai Suodi
    . 2014, 16(5): 286-4.
    Objective To reduce the occurrence of medication error (ME) by analyzing a case of inadequate communication about the rate adjustment of intravenous infusion pump and making improvable plans and carrying out.MethodsAn ME case of category D was analyzed using root cause analysis (RCA). The steps were as follows: forming an RCA team, collecting and analyzing relevant information on this ME event, drawing flowcharts to mine the direct causes, drawing fishbone diagram to confirm the root causes, and making improvable plans.ResultsThe event was identified as "inadequate communication about the rate adjustment of intravenous infusion pump". The direct causes included inadequate communication between doctors and nurses, lack of record about the rate adjustment of intravenous infusion pump, and nurses′heavy workload. The root cause was lack of a mechanism of carrying out and recording of the rate adjustment of intravenous infusion pump. The improvable plans contained establishing and standardizing the mechanism of carrying out and recording of the rate adjustment of intravenous infusion pump, introducing intelligent intravenous infusion pump or designing an appropriate record sheet of the rate adjustment of intravenous infusion pump to note the process of rate adjustment, reinforcing learning and training of medical staff on norm and standard procedure. The implement achievements were as follows. Standard procedure and regulatory framework were established, the appropriate record sheet of the rate adjustment of intravenous infusion pump were designed, doctors were asked to implement written statement of the rate adjustment and explain when shift exchange, and the charge nurses were asked to implement signature confirmation after the rate adjustment. Meanwhile, the learning and training of medical staff were carried on to clarify about the roles. After a follow-up observation of pharmacist, the kind of the event did not recur in the wards.ConclusionME event could be reduced by establishing standardized flow and regulatory framework, introducing advanced technology, and reinforcing learning and training of medical staff.
  • 病例报告
    Liu Jun
    . 2014, 16(1): 40-2.

    A 42-year-old female received warfarin 3.00 mg/d to prevent thromboembolism after replacement of tricuspid valve. On day 3 of treatment, her prothrombin time (PT) was 15.5 s and the international normalized ratio (INR) was 1.3, warfarin was adjusted to 3.75 mg/d. On day 8, the patient presented atrial fibrillation, the heart rate was 81 beats/min, then amiodarone 0.2 g oral administration once daily was added. On day 16, the patient presented hematuria, laboratory tests showed the following values:PT 60.0 s, INR 5.1, urine red blood cell count 300/μl, warfarin was withdrawn immediately and amiodarone was maintained at the original dose. At the same time, the patient received an IM injection of vitamin K1 10 mg. Four hours later, her PT and INR decreased to 48.2 s and 4.1, respectively. The patient was received an IM injection of vitamin K1 10 mg again. Four hours later, her PT and INR decreased to 18.7 s and 1.6, respectively. The urine color gradually returned to normal. On day 17, PT and INR were 18.7 s and 1.6, respectively, urine red blood cell count was zero. The anticoagulant therapy with warfarin 1.50 mg/d was resumed.

  • hao Xiaowei;Chen Hongli;Xu Canli
    . 2015, 17(1): 54-1.
    A 56-year-old female patient with chronic hepatitis B was treated with lamivudine 100 mg once daily. Three years later, the patient developed numbness of extremities. Electromyography showed slower sensory nerve conduction velocity. She was given treatment with vitamin B1 and mecobalamin for two months, but her symptoms was not improved. Lamivudine was discontinued and therefore switched to adefovir dipivoxil 100 mg once daily. Two months later, her symptom of numbness improved significantly.
  • Wang Huijuan;Cao Tao;Wang Zheng;Li Yalin;Wang Changyuan
    . 2015, 17(1): 72-2.
    A 60-year-old male suddenly developed right limb weakness and disturbance of consciousness on process of drinking. One hour later, he was sent to the Emergency Department,Xuanwu Hospital of Capital Medical University. Physical examination showed blood pressure of 70/40 mmHg, heart rate of 112 beats/min, breathing rate of 20 times/min, sluggish light reflex, both upper limbs muscle strength of grade 0, Babinski sign of left side(+)and right side(±). His random blood glucose was 6.4 mmol/L and his cranial CT examination was normal. Electrocardiographic monitoring, oxygen inhalation, and drugs of raising blood pressure were given immediately. Two hours after visiting the emergency department, the patient developed vomiting and received IV naloxone 0.4 mg. About 5 hours after visiting emergency, the doctor was informed from the patient′s family member that the patient might have taken cefaclor. Disulfiram-like reactions due to drinking after administration of cephalosporin antibiotics was considered. Then dexamethasone 5 mg intravenously was given and about 7 hours after visiting the emergency department, the patient′s blood pressure was 90/50 mmHg, light reflex was sensitive, muscle strength was grade 5, and bilateral babinski signs were negative. About 14 hours after visiting emergency department, the patient recovered. Then he said he had taken cefaclor for upper respiratory tract infection.
  • Zou Gongmina;Zhang Xuefenga;Zhang Shilinb
    Adverse Drug Reactions Journal. 2010, 12(6): 396-1.
    A 45yearold male patient with nephrolithiasis selfmedicated with oral propantheline 30 mg for loin and abdomen pain. One hour later, his abdominal pain relieved, but he presented with dry mouth, palpitations, and facial flushing followed by lower abdominal pain and distension, dysuria, and bladder filling. Acute urinary retention was considered. He was placed with a urinary catheter and then he urinated about 2 000 mL in 4 hours. His abdominal distention disappeared and his urinary function gradually normalized. The second day, he urinated by himself.
  • 病例报告
    Cairang Dangzhou;Wu Hailing
    . 2010, 12(6): 429-3.
    A 69yearold man received an IV infusion of clindamycin 0.6 g dissolved in 0.9% sodium chloride 250 mL for prevention of infections following ocular surgery. Twenty minutes later, the patient developed itching and aches in his chest and abdomen, followed by red maculopapular eruption. Clindamycininduced exfoliative dermatitis was diagnosed and the drug was discontinued. The patient was given an IV infusion of 10% calcium gluconate 10 mL and vitamin C 3.0 g added to 5% glucose 250 mL; he was also receiving dexamethasone 10 mg once daily via a Murphy’s dropper and oral loratadine 10 mg once daily. On day 2, furfuraceous skin desquamation occurred on his chest, abdomen, and upper thigh and, on day 3, large areas of exfoliation appeared on his chest and abdomen. After 10 days of treatment, the patient’s skin lesion resolved and he was discharged.
  • 论著
    Bai Yuguo;Wei Guoyi;Zhao Qiang
    . 2011, 13(6): 359-4.
    Objective: To understand the problems of warfarin use in clinical practice and to provide reference for its rational use. Methods: The medical records of patients who stayed in the hospital for more than 7 days and received warfarin with international normalized ratio (INR) monitoring in Beijing Anzhen Hospital from January to May 2010 were collected. The data of the patients’age, gender, dosage and duration of warfarin therapy, INR monitoring frequency, INR values and adverse reactions were collected. According to the primary diseases, the patients were divided into 3 groups: artificial mechanical heart valve replacement group (AMH group), atrial fibrillation group (AF group), and other diseases group (OD group). All results were compared and analyzed among the 3 groups. Results: A total of 339 inpatients were collected. Of them, 252 patients (142 males and 110 females with age from 11 to 78 years) were in the AMH group, 33 patients (23 males and 10 females with age from 20 to 84 years) in the AF group and 54 (38 males and 16 females with age from 12 to 77 years) in the OD group. The medians of warfarin dosage in the AMH, AF and OD groups were 3.0(1.5, 6.0), 3.0(1.5, 3.0) and 3.0(1.5, 6.0)mg, respectively. The medians of warfarin treatment duration in the 3 groups were 9(2, 61), 5(2, 15), and 10(2, 42)d, respectively. The warfarin dosage was higher in the AMH group than in the AF group (P<0.01).The warfarin treatment duration was longer in the AMH and OD groups than in the AF group (P<0.01). The medians of INR monitoring frequency were 5 (2, 21), 1(1, 2) and 6 (1, 20) in the 3 groups, respectively. The percentage of patients who had an INR within safe range in the 3 groups were 40.9% (103/252), 12.1% (4/33) and 46.3% (25/54), respectively; the percentage of patients who had an INR below safe range were 10.7% (27/252), 84.8% (28/33) and 38.9% (21/54), respectively; the percentage of patients who had an INR above safe range were 48.4%(122/252),3.1%(1/33)and 148%(85/54), respectively. The differences in the percentage of patients who had an INR within the safe range between the AMH and AF groups, as well as AF and OD groups were significant; the differences in the percentage of patients who had an INR below the safe range among the 3 groups were significant; the differences in the percentage of patients who had an INR above the safe range between the AMH and AF groups, as well as AMH and OD groups were significant (P<0.01 for all comparisons). Seventy-one (209%) patients had a reversible increase in serum transaminase level, 8(2.4%) had nausea and vomiting, 5(1.5%) had diarrhea, 2(06%) had nasal hemorrhage and 1 (0.3%) prothrombin time prolongation during warfarin treatment. Conclusion: The percentage of inpatients who had an INR within the safe range was lower, especially in patients with atrial fibrillation, and the percentage of patients who underwent artificial mechanical heart valve replacement and had an INR above safe range was higher. This suggests that INR monitoring should be enhanced to improve the rational use of warfarin, and liver function and coagulation indexes should be monitored regularly to reduce occurrence of adverse reactions.
  • 卷首语
    . 2014, 16(1): 1-1.
  • 中毒救治
    Wu Qiong;Guo Xiaoqing;Pu Xiuhong;An Tao
    . 2007, 9(4): 272-272.
    A 3-year-old boy took atenolol 62.5 mg by misuse.Three hours later,he developed restlessness,pale,coldness of extremitis,mild cyanosis,sweating on forehead.His blood pressure was too low to measure.His HR was 80 beats/min.After the treatments of emetic,gastric lavage,catharsis,and fluid replacement,his symptoms were relieved.His blood pressure returned to 100/70 mmHg,and HR increased to 100 beats/min.He was cured and discharged
  • 调查研究
    Liu Min; Wang Ling; Li Ping; Cai Haodong
    . 2008, 10(4): 0-0.
    Objective: To investigate mothertoinfant HBV transmission and infant development in pregnant women with HBV infections during lamivudine therapy. Methods: The data of 15 pregnant women during lamivudine therapy from January 2002 to June 2007 were collected. The liver function and HBV DNA levels of mothers and infants, complications of pregnancy, and infant development were investigated and analyzed. Results: Fifteen women with HBV infections were 27~32 years old (median age 29 years). Their ALT and HBV DNA levels were 86~405 U/L and 6.03×105~2.67×107 copies/ml, respectively. They received lamivudine 100 mg once daily. The treatment time was 4~13 months. The women started to become pregnant after their liver functions returned to normal and HBV DNA levels decreased to <1×105 copies/ml. Lamivudine therapy was continued until labor. Their ALT levels remained normal before and during pregnancy. Their HBV DNA levels decreased to <1×105 copies/ml (80% of the patients <500 copies/ml) before pregnancy. And during pregnancy, 14 patients’HBV DNA levels were not detectable, one patient’s HBV DNA level decreased to 2.45×103 copies/ml. And their ALT levels decreased to 11~41 U/L(median level 23 U/L). No complications of pregnancy were found. The six-month infants’ALT levels were 8~33 U/L (median level 20 U/L), their HBV DNA, HBsAg, and HBeAg were negative, and no abnormal development was observed. Apgar score to neonate was 8~10. Conclusion: Lamivudine appears to be effective in preventing mother-to-infant HBV transmission, and the investigation found no abnormal infant development.
  • 病例报告
    Hao Jianhua;Geng Yanfang
    . 2008, 10(4): 0-0.

    A 50yearold woman was scheduled to receive chemotherapy comprising vinorelbine 40 mg/d on day 1 and 8 in combination with cisplatin 40 mg/d on day 2~4 after undergoing right upper lobectomy for mucinous adenocarcinoma. On day 2 after vinorelbine therapy (before starting cisplatin therapy), the patient developed constipation. After symptomatic treatment, her constipation improved. However, on day 7 after the first cycle of chemotherapy her symptoms aggravated, and abdominal pain and distension, nausea, and vomiting occurred. An abdominal X-ray showed intestinal obstruction. Her neutrophil count decreased to 0×109/L. Vinorelbine therapy was discontinued, and recombinant human granulocyte colony stimulating factor was given. Her constipation did not recur and her neutrophil count increased to 16.48×109/L.

  • 论著
    Yan Honga;Zhang Qianhuanb;Jin Lijuna;Zhang Bina;Dong Taiminga;Wu Handonga
    . 2008, 10(4): 0-0.

    Objective: To compare the frequency and intensity of nephropathy of isosmolar contrast media with lowosmolar contrast media in patients with renal insufficiency undergoing coronary angiography (CAG) or precutaneous coronary intervention (PCI). Methods: Four hundred and sixtyone inpatients with renal insufficiency in our hospital from March 1, 2003 to September 1, 2007 were divided into two groups: the isosmolar contrast media group (131 cases) and the lowosmolar contrast media group (330 cases). All the patients underwent CAG or PCI. The serum creatinine levels on the day before CAG or PCI and on day 1,3, and 7 after CAG or PCI were measured. And the adverse reactions in the two groups were observed. Results: On the day1, 3, and 7 after CAG or PCI, incidence of nephropathy was 6.9%, 19.1%, and 19.8% in the isosmolar contrast media group, and 23.9%, 36.4%, and 39.4% in the lowosmolar contrast media group, respectively. The deferences between the two groups were statistically significant(all P<0.05). On the day 1 and 3 after CAG or PCI, the increased serum creatinine levels were (15.8±55.5) μmol/L and (123±58.0) μmol/L in the isosmolar contrast media group, and (20.1±53.7) μmol/L and (38.3±62.4) μmol/L in the lowosmolar contrast media group, respectively. The deferences between the two groups were statistically significant (all P<0.05). Conclusion: Isosmolar contrast media is less nephrotoxic than lowosmolar contrast media used in the patients with renal insufficiency. And it is safer for the patient with renal insufficiency undergoing CAG or PCI.

  • Guo Huijuan
    Adverse Drug Reactions Journal. 2010, 12(1): 69-1.
    A 26yearold women received Lulutongyimugao 10 ml orally after delivery. Five minutes later, the patient developed generalized skin itching, palpitation, dizziness, nausea, vomiting, and throat discomfort. About twenty minutes later, she presented with edema of lip, cyanosis, and dyspnea. Physical examination showed a BP of 90/55 mm Hg and a heart rate of 170 beats/min. Lulutongyimugao was withdrawn, and she was treated with an IV infusion of dexamethasone and vitamin C, oxygen inhalation, and underwent breath and ECG monitoring. Half an hour later, her symptoms relieved; one day later, her vital signs became stable. She was discharged after three days of hospitalization.
  • Wang Suobin;Jia Jianping
    Adverse Drug Reactions Journal. 2010, 12(1): 56-3.
    Two patients developed osmotic demyelination syndrome after receiving an IV infusion of pituitrin for hemoptysis secondary to pulmonary tuberculosis. Patient 1, a 45yearold man,received an IV infusion of pituitrin 10U on day 1, followed by 24~36U/d on days 2, 3, and 4. On day 5, pituitrin was discontinued. Pituitrin 24U/d was readministered for 2 days due to recurrence of hemoptysis. Subsequently, the patient developed agitation, paraphasia, and involuntary movement of his extremities. Laboratory testing revealed a blood sodium level of 110 mmol/L. After receiving a sodium supplement for 2 days, his blood sodium level increased to 134 mmol/L. A cranial MRT revealed symmetrical signal abnormities on long T1 and long T2 in his bilateral caudate nuclei and lenticular nuclei. Symptomatic treatments were given and the patients’symptoms improved somewhat.
  • 调查研究
    Wang Yu
    . 2002, 4(4): 225-226.
    Objective: To observe adverse reactions associated with rabies vaccine. Method: From August 2000 to October 2001, 1152 visits of outpatients were injected with rabies vaccine in our hospital and resulting reactions were surveyed. Results: Adverse reactions appeared in 12 cases, male 1 and female 11, accounting for 1.04% and happening after first injection of vaccine (8 cases), second injection (3) or over three injections (1). The manifestations varied from mild (4 cases) to moderate (6) to severe (2), such as local induration, general urticaria, dizziness, fever and the like. Conclusion: Rabies vaccine could cause adverse reactions, so the monitoring after its injection is important for professional practices.
  • Liu Yu;Zhang Yuanyuan;Wu Yimei;Zhao Xiuli;Zhang Xiaoshu
    Adverse Drug Reactions Journal. 2009, 11(3): 203-3.

    An 18-year-old man with epilepsy received carbamazepine treatment for 3 months, but no effects were observed, then carbamazepine was changed to sodium valproate 0.2 g daily for 40 days and more. Subsequently, the patient suddenly developed convulsion on limbs with unconsciousness, then he was hospitalized. His consciousness recovered after management. He presented with dizziness, diplopia, nausea, vomiting, and tinnitus. Examination revealed dysarthria, nystagmus and ataxia. On day four after admission, his blood ammonia level was 117.6 μmol/L. Routine blood testing and liver and renal function examination were normal. A brain MRI found no marked abnormalities. His symptoms improved after discontinuation of sodium valproate and his dizziness recurred after readministration of sodium valproate. Sodium valproate was stopped immediately and switched to clonazepam. His symptoms disappeared. His blood ammonia level decreased to 66 μmol/L.

  • 中药不良反应
    Liu Xiurong;Fu Lijun;Miao Bichuan
    . 2008, 10(2): 150-2.

    A 55yearold woman took 1 000 ml of senna infusion (1 ml was equivalent to senna 0.03 g) rapidly at night before colonoscopy. Two hours later, she developed frequent diarrhea. Six hours later, abnormal behavior, rave, and dysphoria occurred. Her blood sodium level was 120 mmol/L. Druginduced hyponatremia was suspected, and sodium chloride 3% was given intravenously. The next day, the patient regained normal consciousness and her blood sodium level return to normal limits.

  • 药物误用
    Guo Yuzhi;Ji Fangru;Tian Yin
    . 2009, 11(2): 122-1.
    A 35yearold woman received an IV infusion of azithromycin 0.5 g dissolved in 250 ml of glucose injection 5% once daily for acute laryngopharyngitis. The woman experienced difficulty falling asleep at night. The next day, the same symptom reappeared after infusion. She was administered with 5 Anshen tablets, followed by oral diazepam 10 mg, but her insomnia did not improve. Azithromycin was withdrawn and switched to an IV infusion of levofloxacin 100ml once daily. Her sleep normalized one day later. A review of her medical history showed that she had developed insomnia after azithromycin treatment one year before.
  • 临床论著
    Fan Long;Xue Jixiu;Wang Tianlong
    . 2009, 11(3): 161-4.
    Objective: To observe the changes in serum amyloid-beta (1-40) [Aβ(1-40)]and zinc levels in elderly patients receiving general anesthesia with isoflurane during perioperative period. Methods: From June 2007 to March 2008, forty patients planning to undergo laparatomy were enrolled in the study. The patients were divided into following two groups based on age: the elderly patient group (20 cases) and the nonelderly patient group (20 cases). The elderly patient group comprised 12 men and 8 women with average age of (72.39±4.11) years. The nonelderly patient group comprised 11 men and 9 women with average age of (48.15±5.62)years. After transferring to the operation room, the patients in both groups received anesthesia induction and endotracheal intubation, followed by isoflurane 1 to 1.5 minimal alveolar concentration (MAC) for anesthesia maintenance. Three ml of blood was taken from the patients’cubital vein before anesthesia and 2, 4, and 24 hours after anesthesia, respectively. Serum Aβ(1-40) and zinc levels were measured with ELISA and biochemical analysis, respectively. Results: Average serum Aβ(1-40) level before anesthesia in the elderly patient and nonelderly patient groups were (5.03±1.96)μg/ml and (3.92±0.46) μg/ml, respectively. The difference was statistically significant (P<0.05).Average serum Aβ(1-40) levels 2,4, and 24 hours after anesthesia in the elderly patient and nonelderly patient groups were increased: (7.95±1.66) μg/ml, (7.63±1.51) μg/ml, (6.94±1.43) μg/ml and (5.15±0.72) μg/ml, (6.34±0.99) μg/ml, (4.81±0.81) μg/ml, respectively. The differences in Aβ(1-40) level in both groups between before anesthesia and after anesthesia, as well as at different time points after anesthesia between the two groups, were statistically significant (all P<0.05). Average serum zinc levels before anesthesia in the elderly patient and non-elderly patient groups were (14.36±1.38) μg/ml and (14.64±1.75)μg/ml, respectively. Serum zinc levels 2,4 and 24 hours after anesthesia in the elderly patient and nonelderly patient groups were (12.71±1.36) μg/ml, (10.64±1.83) μg/ml, (8.07±1.61) μg/ml and (13.10±1.68) μg/ml, (11.16±1.74) μg/ml, (9.40±1.99) μg/ml, respectively. The differences in serum zinc levels in both groups between before anesthesia and after anesthesia, as well as 24 hours after anesthesia between the two groups, were statistically significant (all P<0.05). Conclusion: Markedly increased serum amyloid-beta (1-40) levels and decreased serum zinc levels occur in elderly patients receiving general anesthesia with isoflurane during perioperative period.
  • 病例报告
    . 2005, 7(2): 129-129.
    A 51-year-old man was hospitalized with severe pain on waist and limitation of movement for one hour. He was diagnosed as compression fracture on lumbar vertebrae 1, and treated with intravenous infusion of sodium aescinate 10mg daily. The patient developed fever, sweat, nausea, fatigue, anorexia, yellowing of sclera and the skin after receiving the medication. Physical examination showed tenderness on right upper abdomen and percussion pain on both renal areas. Lab findings showed ALT 753U/L, T-Bil 80.1μmol / L and BUN 19.44mmo / L. It was considered to be drug-induced hepatorenal impairment. Sodium aescinate was then withdrawn. 10 days later his conditions were returned to normal.
  • 病例报告
    . 2000, 2(3): 189-190.
  • Dai Rui, Zhang Qingxia, Hu Yang, Wang Huanling, Zhao Bin, Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs
    Adverse Drug Reactions Journal. 2023, 25(8): 475-481. https://doi.org/10.3760/cma.j.cn114015-20220801-00693
    Objective To understand the current situation and problems of research design in adverse drug reaction (ADR) signal detection study in China. Methods The literature on ADR signal detection study in SinoMed, CNKI, WanFang Data and VIP databases were retrieved (up to May 30, 2022). The research purpose, research direction (target drug, target ADR), source database of signals, target drug role, reference drug, signal detection algorithm, and bias control of the literature were analyzed descriptively one by one. Results A total of 165 articles were included, of which 146 (88.5%) were published in core journals. From 2013 to 2022 (January to May, 2022), there were 4, 3, 2, 7, 8, 11, 20, 29, 55, and 26 relevant articles, respectively. Problems in these studies were as follows: research purposes were not clear in 6.7% (11/165) of the literature; target ADRs were selected as non targeted in 80.6% (133/165) of the literature; the domestic database was less utilized [only 9.7% (16/165)]; did the selection range of the target drug role were not mentioned in 33.9% (56/165) of the literature; only a single algorithm for signal detection was used in 36.4% (60/165) of the literature; bias analysis was not conducted in 85.5% (141/165) of the literature. Conclusions The domestic literature on ADR signal detection has problems of poor standardization in research design, such as unclear research purpose and direction, incomplete research items, etc. Chinese scholars should further improve the quality of research design while strengthening the research on ADR signal detection.
  • 调查研究
    Yang Xiaoqing;Yao Hai;Huang Yiming;Liu Fei
    . 2005, 7(6): 421-423.
    Objective: To analyse allergic reactions caused by Yuxingcao injection in clinical practice. Methods: 120 cases with allergy due to Yuxingcao injection were retrieved and analysed from"China Periodicals Database"(1994-2005.1). Results: It was shown that Yuxingcao injection-induced allergy was not related to sex and age of patients but related to route of administration(P < 0.05), intravenous infusion in particular. The main clinical symptoms were cardiac distresss,dyspnea, mental confusion and others,featuring fast start and quick development, and 92.50% of the reactions occurred within 30 minutes after treatment (P < 0.05). Among 120 cases, 37 were anaphylactic shock (accounting for 30.83%) and 23 of them were severe. Conclusion: Immediate hypersensitivity reactions(such as anaphylactic shock) due to Yuxingcao injection should be paid more attention by medical staffs.
  • 学术研讨
    . 2006, 8(1): 12-16.
    他莫昔芬是一种选择性雌激素受体调节剂,在不同的靶组织内可表现雌激素或抗雌激素样作用。它是乳腺癌内分泌疗法的常用药物之一,但是他莫昔芬在子宫内膜表现雌激素样作用,有增加子宫内膜癌的危险。因此,对服用他莫昔芬患者的密切监测、随访显得十分重要。本文对他莫昔芬作用机制;服用他莫昔芬后内膜受体变化;他莫昔芬致子宫内膜病变的组织病理类型、分期、分级;DNA损伤情况和患者的监测进行文献复习。
  • 综述
    . 1999, 1(2): 80-85.
  • Xiao Lan;Yang Mingli
    Adverse Drug Reactions Journal. 2009, 11(6): 443-2.
    A two years and ten months girl was hospitalized for cough and fever. Routine blood tests revealed the following levels: WBC count 10×109/L, Hb 105g/L,PLT count 188×109/L. The patient was given with cefuroxime sodium for 5 days but the therapy had poor effect. Lobar pneumonia was considered. On day 6 of admission, his routine blood test showed a WBC count of 14×109/L, a Hb level of 97g/L, and a PLT count of 254×109/L. He received imipenemcilastatin sodium 70 mg every eight hours. On day 11 of admission, routine blood test revealed the following: WBC count 15.7×109/L, Hb 104 g/L, PLT count 1 349×109/L. Bone marrow aspiration showed marked hyperplasia and all kinds of megakaryocytes and platelets covering smear. On day 13, imipenemcilastatin was discontinued. On day 14, routine blood test revealed a WBC count of 6.9×109/L, a Hb level of 104 g/L, and a PLT count of 226×109/L.
  • 病例报告
    Zhou Xianghong;Zhu Xiaohua;Li Ling;Wu Hong
    . 2007, 9(4): 288-288.
    A 55-year-old woman with type 2 diabetes mellitus took glimepiride 2 mg once daily at half hour before breakfast.Three days later,she developed vertigo.A TCD examination revealed cerebral arteriosclerosis and vertebra-basilar artery insuf-ficiency.She was received anti-vertigo therapy with flunarizine,difenido,and scopolaline.But the efficacy of the therapy was not apparent.After 3 days of therapy,the dose of glimepiride was increased to 4 mg once daily for increased blood glucose.After one hour of administration,her vertigo was aggravated,and accompanied with nausea and vomit.Because the patient could not take glimepiride,the vertigo was relieved at night of the next day and disappeared 4 days later.One hour of using glimepiride again later,the vertigo was recurred.Glimepiride was stopped.28 hours later,the patient's symptoms of vertigo disappeared
  • 中药不良反应
    Lei Lili①;Jing Hongying①;Zhang Lizhi②
    . 2007, 9(6): 442-442.
    A 73-year-old woman with cerebral thrombosis took 10 ml of Xiedukang oral solution twice daily.About two months later,she developed dark urine,yellowing of the skin,mucous membrane,and sclera.After the drug was stopped,the liver function examination revealed the results as follows:ALT 417 U/L,AST 413 U/L,ALP 186 U/L,TBA 112.8 μmol/L,and Tbil 238.3 μmol/L.After liver-protective treatment,the patient's jaundice resolved,and her liver function returned to normal levels.
  • 病例报告
    Feng Hua;Wei Limin;Wang Kejie;Lang Yu
    . 2007, 9(6): 392-409.
    A 39-year-old man with right renal lithiasis was scheduled to receive operation under general anesthesia.Anesthesia was induced with midazolam 5 mg,fentanyl 0.2 mg,vecuronium bromide 8 mg,and propofol 40 mg by IV bolus.Tracheal intubation was performed and anesthesia was then maintained with vecuronium bromide 4 mg/h,propofol 100 mg/h,and remifentanil 0.25 mg/h by continuous intravenous infusion.After intubation,the patient developed bronchospasm.His airway pressure rose to 40 cmH2O,and SpO2 decreased to 0.78.Wheezing rales in the lungs were heard.Despite treatment with isoflurane inhalation,IV aminophylline,dexamethasone,and the ketamine,and the cessation of remifentanil infusion,the symptom did not obviously improve.After stopping vecuronium bromide infusion was stopped,the patient's airway pressure gradually fell off and the wheezing rales in the lungs decreased.Propofol was discontinued.Thirty minutes later,the patient breathed spontaneously after extubation.His SpO2 returned to 0.99.The wheezing rales almost disappeared.
  • 病例报告
    . 2000, 2(1): 49-49.
  • ZHU Xiao-li; WANG Zhen; WANG Pu;CHEN Xiao-wei
    ObjectiveTo investigate the rational use of antibiotics for infection prophylaxis in retroauricular expander implantation during perioperative period.MethodsThe subjects were 63 consecutive patients, who received retroauricular expander implantations in Peking Union Medical College Hospital from February 4th, 2013 to July 10th, 2013. The surgical patients hospitalized from February 4th to June 9th received IV infusion of sodium cefmetazole 1-2 g twice daily from 30 min before the operation to 2 days after the operation in 3 consecutive days (the 3-day medication group); the surgical patients hospitalized from June 13th to July 10th received only one time of IV infusion of cefuroxime 0.75-1.50 g 30 min before the operation and the infusion must be finished within 30 min (the one-time medication group). There were 32 patients in the 3-day medication group. Of them, 26 patients were men and 6 were women with ages from 6 to 38 years and an average age of (11.5±6.5) years; 26 patients were <14 years, 3 were 14-17 years, and 3 were ≥18 years. There were 31 patients in the one-time medication group. Of them, 26 patients were men and 5 were women with ages from 6 to 32 years and an average age of (12.3±6.3) years; 22 patients were <14 years, 5 were 14-17 years, and 4 were ≥18 years. There was no significant difference in ages between the 2 groups (P=0.73). All patients were implanted with 50 ml reniform expander. Negative pressure drainage tubes were placed in all surgical patients and could not be pulled out until the liquid became serum-like fluid with light-yellow color and less than 5 ml. The situation of surgical site infections and adverse reactions during perioperative period were observed. ResultsThe drainage time was 4-5 days with an average of 4.4 days in the 3-day medication group and 3.5-4.5 days with an average of 4.2 days in the one-time medication group. There was no significant difference in the drainage time between the 2 groups (P=0.07). The incisions in all patients healed well and no infections or hematoma occurred. Eczema or herpetiform changes on skin behind ear appeared in one patient in the three-day medication group and in one patient in the one-time medication group, respectively. One patient developed rashes on the neck and chest in the one-time medication group. The rashes disappeared after symptomatic treatments.ConclusionsPreoperative one-time treatment with bactericidal antibiotics is enough for postoperative infection prophylaxis in retroauricular expander implantation. It′s a rational regimen of antibiotic use and worthy of clinical popularization.
  • 病例报告
    NIE Wen-bin
    . 2012, 14(1): 45-3.

    A 71-year-old man was hospitalized with acute cerebral infarction, ventricular premature beats and hyperhomocysteinemia. He received an IV infusion of Shuxuetong (疏血通) injection 6 ml, Xingnaojing (醒脑静) injection 20 ml and piracetam injection 250 ml once daily, and oral administration of aspirin 0.1 g,folic acid 5 mg and mecobalamin 500 μg once daily. In addition, the patient received atorvastatin calcium 10 mg once daily for bilateral carotid atherosclerosis which was diagnosed using ultrasonography. His creatine kinase(CK) was 90 U/L on admission and was increased to 777 U/L and 1332 U/L on days 3 and 6 of atorvastatin calcium therapy, respectively. The dark urine appeared and urinary occult blood test was positive. Atorvastatin calcium was withdrawn and other treatment was unchanged. The CK level was decreased to 1126 and 129 U/L on days 3 and 7 of drug withdrawal, respectively. The urine became light yellow in color and urine occult blood test was negative.

  • 病例报告
    Liu Haiyana;Li Tingtinga;Wang Yafengb;Yang Guipingb;Liu Hongb
    . 2011, 13(4): 259-2.

    A 46-year-old female patient received aspirin 0.1 g once daily,atorvastatin calcium 10 mg once daily, bezafibrate 0.2 g twice daily, and nifedipine 30 mg twice daily for 10 days for hyperlipidemia and primary hypertension. On day 8 of treatment, the patient experienced muscular pain in both lower limbs and, on day 9, the pain progressed to involve her bilateral shoulder and back, both upper extremities, and then the whole body. Thereafter, she present with aggravated generalised muscular pain, muscle stiffness in both lower limbs, and red-brown urine. Biochemical blood tests showed the following levels: creatine kinase 21 507 U/L, creatine kinase MB 5460 U/L, lactate dehydrogenase 1517 U/L, alanine aminotransferase 194 U/L, aspartate aminotransferase 895 U/L, and creatinine 268 μmol/L. The patient improved after receiving blood purification, urinary alkalinization, as well as liver and kidney protective treatment.

  • 病例报告
    Li Jie;Li Yang
    . 2011, 13(2): 110-3.
    A 66yearold man with myocardial infarction was hospitalized and underwent percutaneous transluminal coronary angioplasty and stenting immediately. The day after surgery, he received clopidogrel 75 mg once daily, intial dose of aspirin 300 mg followed by 100 mg per day, fluvastatin 20 mg once daily, and fosinopril sodium 10 mg once daily. One month later, the patient developed chills and high fever. Routine blood tests revealed the following values: white blood cell count 1.1×109/L with neutrophils 0.034, absolute value of neutrophils 0.037×109/L, red blood cell count 3.6×1012/L, hemoglobin 113 g/L, and platelet count 119×109/L. Bone marrow aspiration and biopsy showed nonsevere aplastic anemia. He received symptomatic treatment, his routine blood tests showed marked decreases in his complete blood count. On day 44 of hospitalization, routine blood tests revealed the following values: white blood cell count 2.6×109/L with neutrophils 0.367, absolute value of neutrophils 0.954×109/L, red blood cell count 3.6×1012/L, hemoglobin 113 g/L, and platelet count 84×109/L. Clopidogrel and aspirin were withdrawn immediately and switched to warfarin 2.5 mg once daily and cilostazol 100 mg twice daily,other medicines continued also. Subsequently, the routine blood tests were performed, and complete blood count gradually increased after reaching the lowest values. Bone marrow aspiration was repeated two times and results showed that bone marrow picture gradually returned to normal. On day 102 of hospitalization, routine blood tests revealed the following values: white blood cell count 5.8×109/L with neutrophils 0.552, absolute value of neutrophils 3202×109/L, red blood cell count 4.2×1012/L, hemoglobin 140 g/L, and platelet count 170×109/L. He was prescribed clopidogrel 50 mg once daily, aspirin 100 mg once daily. One week later, his routine blood tests showed marked decreases in complete blood count and, two weeks later, routine blood tests revealed the following values: white blood cell count 3.4×109/L with neutrophils 0.349, absolute value of neutrophils 1.187×109/L, red blood cell count 4.0×1012/L, hemoglobin 133 g/L, and platelet count 176×109/L. Subsequently, clopidogrel alone was stopped and changed to cilostazol 100 mg thrice daily. After one week, his blood picture normalized.
  • 病例报告
    Zeng Huiqing;Zheng Yali;Lv Zhi;Zhang Xueling;Wang Huiling
    . 2010, 12(3): 215-2.
    A 71yearold man received voriconazole for aspergillosis. An IV infusion of voriconazole 300 mg twice daily on day 1 and 200 mg twice daily on day 2 were given. Two days later, the patient developed short of breath, tachycardia and was unable to keep horizontal position. A blood gas analysis revealed the following value: pH 7.32,PO2 7.02 kPa,PCO2 8.59 kPa,BE-6.25. On day 4, his 24hour urine volume was 300 mL, and his BUN and SCr levels were 28.32 mmol/L and 318 μmol/L, respectively. Voriconazole was considered to be the causative agent for type Ⅱ respiratory failure with acute renal failure. Voriconazole was discontinued and change to an IV infusion of micafungin 100 mg/d. Meanwhile symptomatic therapy and hemodialysis were given.Three days later, the patient returned to normal gradually.
  • 中毒救治
    Li Qing;Lei Zhaobao
    . 2010, 12(4): 276-2.
    A 44yearold woman started receiving an IV infusion of amoxicillin 6 g dissolved in 500 mL of 0.9% sodium chloride once daily for preventing infection 5 days before undergoing hysteromyomectomy. On day 6, the patient developed hematuria 15 minutes after surgery, and serum creatinine level was 140.99 μmol/L. Acute renal failure was considered to be related to amoxicillin overdose. Amoxicillin was discontinued and switched to cefotaxime and mezlocillinsulbactam. Meanwhile she was given furosemide, pantoprazole. On day 14 after surgery, the patient’s renal function returned to normal.
  • 论坛
    Ding Huiguo
    . 2014, 16(3): 132-2.
  • . 2016, 18(2): 157.
  • Mei Dan, Ni Meixin, Gao Jie
    . 2016, 18(3): 213.
    An 88-year-old female with pulmonary adenocarcinoma received gefitinib 250 mg once daily. Four days after gefitinib treatment, the patient presented with aggravated chest distress and short of breath in resting state. Seven days later, she still had the above-mentioned symptoms and gefitinib was withdrawn. The pulmonary CT scan showed diffusive exudation in her bilateral pulmonary and acute interstitial pneumonia was considered. After treatments with methylprednisolone and anti-infective drugs, the patient′symptoms relieved for a while, but she died from pulmonary infection combined with respiratory failure finally.
  • ADR系列问答
    . 2014, 16(6): 326-1.
  • Zhou Ting;Wang Chunjiang;Su Qunfang
    . 2015, 17(1): 49-5.
    PubMed, Nature database, ScienceDirect database and China National Knowledge Infrastructure(from year 2009 to 2013)were searched. The journal articles on correlation between gene polymorphism and adverse drug reactions were collected and analyzed. This article reviews the articles on correlation between adverse drug reactions and pleomorphic gene of metabolic enzymes, transporters, immune molecule and receptors. The metabolic enzymes mainly included cytochrome P450 2C9, N-acetyltransferase 2, uridine diphosphate glucuronosyl transferase 1A6, methylenetetrahydrofolate reductase, matrix metalloproteinase-9 and dihydropyrimidine dehydrogenase. The transporters mainly included solute carrier family 22 member 2, calcium channel, voltage-dependent, gamma subunit 6, solute carrier family 6 member 12, and ATP-binding cassette B1. The immune molecules mainly included human lymphocyte antigen (HLA) for instance HLA-B, HLA-A and HLA-C. The receptors mainly included dopamine 2 receptors/ankyrin repeat and kinase domain containing 1 Taq IA, chemokine receptor 3, orphan nuclear receptor NR4A1, pregnane X receptor and interleukin-4-receptor alpha. Understanding the relationship between gene polymorphism and adverse drug reactions is helpful to facilitate individualized drug administration and avoid or reduce the occurrence of adverse reactions.
  • An Hong, Wu Liyong, Yin Na, Song Haiqing, Jia Jianping
    . 2015, 17(6): 456-457.
    A 36-year-old women with epilepsy received oral carbamazepine 0.4 g twice daily for ten years (blood concentration of carbamazepine ranged from 5.5 to 9.5 μg/ml) and received oral erythromycin cycloocarbonate 0.5 g twice daily for wheezing and infection. Six to seven hours after first dose of oral erythromycin cyclocarbonate, she developed acute dizziness and walking instability, aggravated during the next day, and accompanied by blurred vision. On the third day, the patient′s dizziness aggravated further, she could not stand up and walk independently and developed nausea and vomiting. Blood concentration of carbamazepine was 24.1 μg/ml. It was highly suspected that the patient′s ataxia was caused by the interaction of carbamazepine and erythromycin cyclocarbonate. Erythromycin cyclocarbonate was immediately discontinued,while the dosage of carbamazepine was reduced. At the same time intravenous fluid and symptomatic treatments were given. Twenty-four hours after treatments, the patient′s dizziness was obviously improved. Five days later, her ataxia disappeared and her blood concentration of carbamazepine was 10.3 μg/ml. At 3 months of follow-up, dizziness and ataxia did not recur.
  • 安全用药
    Lu Meihua
    . 2010, 12(4): 269-4.

    Linezolid is an oxazolidinone antibacterial widely used for the treatment of infections caused by vancomycinresistant enterococci and meticillinresistant staphylococcus aureus. The patients may developed increased blood lactate level, even lactic acidosis 1-16 weeks after linezolid administration. The clinical presentations are nausea, vomiting, diarrhea, tachycardia, and mental confusion. The mechanism of lactic acidosis induced by linezolid may be related to inhibit mitochondrial protein synthesis. The measures of prevention and treatment are as follows: the blood lactic acid should be monitored during linezolid treatment; if the blood lactate level is higher than the normal value, the drug should be discontinued; the patient with severe lactic acidosis should be given symptomatic treatment; linezolid combined with SRRIs should be avoided.

  • 病例报告
    Ren Xiaolei;Xu Pan;Li Yuzhen
    . 2010, 12(3): 217-2.
    Two male patients, aged 87 and 74 years, respectively, received an IV infusion of moxifloxacin 0.4 g once daily for pulmonary infections. On day 3, they both developed creatine kinase elevation and positive occult blood in urine. Their CK levels were 5 964U/L and 3 531U/L, respectively. Patient 1 experienced pressing pain on bilateral calf muscle. Moxifloxacin was discontinued and the two patients were given ceftazidime and meropenem, respectively. Treatment with alkalinization of their urine was given and their symptoms improved.
  • 病例报告
    Dai Huiqing;Zhang Wenyue;Li Quanzhi
    . 2010, 12(3): 211-2.
    A 55yearold woman received quetiapine 0.2 g once daily and zolpidem 5 mg at bedtime for abnormal behavior, agitation, and insomnia. After 9 days of treatment, the patient developed dysphagia, polyhydrosis, followed by gradual dysphasia, occasional delirium state, involuntary convulsion of both hands and hypermyotonia in extremities. Her temperature was 38℃ and blood pressure was 171/87 mm Hg. Laboratory tests revealed the following values: WBC count 24.2×109 /L, CK 22 820 U/L, CK-MB 225 U/L, myoglobin 1 790 U/L, LDH 2 565 U/L. Quetiapine and zolpidem were discontinued the electrolyte abnormalities were corrected, and she received liverprotective treatment, supportive therapy with nutrition, and hemodialysis. On day 10, the symptoms relieved obviously. And she was discharged after 36 days of hospitalization.
  • 病例报告
    Jiang Lianhua
    . 2011, 13(3): 195-1.
    A 40-year-old woman received an IV infusion of ceftriaxone sodium 2.0 g dissolved in 0.9% sodium chloride 250 ml for her upper respiratory tract infection (gastrointestinal type). About 5 minutes after infusion start, the patient experienced chest tightness, dyspnea, followed by convulsions, foam at mouth and no response to verbal stimuli. The medicine was discontinued immediately, and her blood pressure was undetectable. She received endotracheal intubation and anti-shock therapy. Two hours later, her BP increased to 138/68 mm Hg, but she remained in a moderate coma. The patient was hospitalized and then she received anti-shock therapy and the treatment for the correction of acid-base disturbances. On day 2 of admission, a head CT showed diffuse swelling in the brain tissue. During 3 weeks in hospital, the patient was still in a coma. Nine months after discharge, the patient remained in a vegetative state.
  • 病例报告
    YANG Zhong-hui;ZHOU Yong-qi;CHEN Guo-mei
    . 2012, 14(1): 52-3.

    A 74-year-old man with high uric acid received oral allopurinol 0.1 g twice daily. On day 16, the patient presented with generalized itching and, on day 21, pin tip-like red rash on his skin of chest and back appeared. No improvement occurred despite the drug was discontinued and a 2-day symptomatic therapy was given. Aggravated rash, dizziness, and chest tightness appeared in the patient and then he was admitted to hospital. After admission, examinations showed the following levels and values: heart rate 73 beats / min, blood pressure 70/46 mm Hg, alanine aminotransferase 124 U/L, aspartate aminotransferase 80 U/L, blood urea nitrogen 22.6 mmol/L, serum creatinine 151 μmol/L, and uric acid 738 μmol/L. After admission, his heart rate decreased to 42 beats/min on one occasion. After a 21-day symptomatic and supportive treatment, his rash disappeared basically and blood pressure, heart rate and renal function normalized, while liver function remained abnormal.

  • 论著
    QIAN Ying
    . 2013, 15(2): 73-6.
    ObjectiveTo evaluate the monitoring quality of adverse events following immunization (AEFI) from 2009 to 2011 in Guangling District, Yangzhou City, Jiangsu Province preliminarily. Methods
    The data of AEFI in Guangling District from 2009 to 2011 were collected through the AEFI information system of China and analyzed by descriptive epidemiological method.ResultsA total of 24 kinds of va-ccine were inoculated from 2009 to 2012 in Guangling District, the accumulative total inoculation doses were 732 005, the accumulative total AEFI cases were 388, the reporting rate was 53.7 per 100 000 doses. In seven state indicators of AEFI monitoring system, reporting rate within 48 hours, investigation rate within 48 hours, and classification rate were 100.0%. The input rate of questionnaire within 3 days, upload rate of investigation report within 7 days, integrity rate of key project in questionnaire, and report coverage rate in districts were not up to the standard of AEFI during 2009. The input rate of questionnaire within 3 days and upload rate of investigation report within 7 days were increased greatly during 2010, but were not up to the standard of AEFI yet. The completion rate of all indicators of AEFI monitoring system reached 100.0% since 2011. Of 388 cases of AEFI, the common adverse reactions were found in 330 cases (850%), the main clinical manifestations were fever, red swelling and induration in injection area. The abnormal reactions were found in 50 cases (12.9%), the clinical manifestations were allergic skin rashes (40 cases, 80.0%), angioedema (3 cases, 6.0%), BCG abscess (2 cases, 4.0%), morbilliform rash (2 cases, 4.0%), allergic purpura (1 case, 2.0%), febrile convulsion (1 case, 2.0%), and diarrhea (1 case, 20%). The coincidental events occurred in 8 cases (2.1%). The top five vaccines associated with reporting rate of AEFI were pneumococcal 7-valent conjugate vaccine(PCV-7,507.9/100 000), 23-valent pneumococcal polysaccharide vaccine (343.2/100 000), poliomyelitis vaccine (monkey kidney cell) oral (166.7/100 000), hemophilus influenzae type b conjugate vaccine(163.8/100 000)and measles and rubella combined vaccine, live (MR,147.1/100 000). The top five vaccines associated with abnormal reactions reporting rate were MR(88.3/100 000), PCV-7(63.5/100 000), influenza vaccine (split virion), inactivated(17.0/100 000), MR(16.9/100 000)and measles vaccine, live(13.7/100 000).ConclusionsThe operation quality of AEFI surveillance system in Guangling District, Yangzhou City improves year by year from 2009 to 2012. The completeness and sensitiveness are well.
  • 病例报告
    Chen Hui;Zhu Wei;Lian Shi
    . 2008, 10(5): 0-0.

    A 24-year-old man with symptomatic epilepsy received an intermittent therapy of sodium valproate for 16 years. On admission, his ALT and AST levels were 41 U/L and 56 U/L, respectively. The patient's ALT and AST levels increased to 224 U/L and 99 U/L respectively 9 days after undergoing epileptogenic focus resection. He was given an IV infusion of diammonium glycyrrhizinate 150 mg mixed with 5% Glucose injection 250 ml once daily. Four days later, the man developed bilateral erythema and blister with pruritus in his extremities. Subsequently, his erythema progressed to involve his neck, axillary fossa, cubital fossa, groin, and popliteal fossa. These lesions consisted of a central maculopapule and papulovesicle surround by erythematous ring. Druginduced eczematid was diagnosed. Diammonium glycyrrhizinate was stopped, and cetirizine and vitamin C were given. Three days later, skin eruption and pruritus subsided. According to his history, he experienced generalized erythema with pruritus after treatment of an IV infusion of diammonium glycyrrhizinate one year ago.

  • 病例报告
    HouHuiling
    . 2008, 10(3): 183-2.
    A 51yearold woman with a history of allergic disorders received budesonide for inhalation and oral montelukast sodium 10 mg daily for treating bronchial asthma. On day 3, the patient experienced skin rash with pruritus on her extremities. Montelukast sodium was discontinued immediately, and budesonide was continued. She was treated with loratadine 10 mg daily. Three days later, the skin rash lessened; and one week later, the skin rash disappeared.
  • 临床论著
    Luo Leiming;Zhu Qiwei;Zhu Bing;Ma Qin;Zeng Qiang;Yang Xue;Wu Hongmei;Mao Li;Ye Ping
    . 2009, 11(5): 305-5.

    Objective: To assess the efficacy and safety of homemade bezafibrate in treatment of hypertriglyceridemia. Methods: Form May 2006 to July 2007, 132 patients with hypertriglyceridemia were enrolled in the study and randomly divided into the following three groups: the bezafibrate group (59 cases), the fenofibrate group (55 cases), and the control group (18 cases). The bezafibrate group comprised 45 male and 14 female patients with an average age of (51.4±15.4) years. The fenofibrate group comprised 42 male and 13 female patients with an average age of (51.5±15.5) years. The control group comprised 13 male and 5 female patients with an average age of (52.7±16.0) years. The bezafibrate group was administered bezafibrate 200 mg orally thrice daily, the fenofibrate group was administered fenofibrate 100 mg orally thrice daily, the control group received nondrug therapy. The duration of treatment was 3 months. The blood levels of triglyceride, total cholesterol , low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol were measured before and after therapy and compared among the three groups. The adverse reactions were observed. Results: In the bezafibrate and fenofibrate groups, the levels of TG, TC and LDL-C were respectively(3.16±0.60),(5.25±0.56),(2.76±0.45)and(3.13±0.55),(5.28±0.52),(2.82±0.41)mmol/L before treatment and deceased respectively to (2.42±0.43),(4.93±0.47),(2.55±0.44)and(2.43±0.43),(4.97±0.47),(2.48±0.45)mmol/L after treatment, and the differences were statistically significant (all P<0.01); the levels of HDL-C were respectively (1.09±0.18) and (1.10±0.16) mmol/L before treatment and increased respectively to (1.23±0.13) and (1.22±0.18) mmol/L after treatment, and the differences were statistically significant (all P<0.01). In the control groups, after treatment, the levels of TG, TC, and LDL-C were respcetively (3.10±0.40), (5.22±0.42), and (2.81±0.57)mmol/L, which were higher than those in the bezafibrate group (P<0.05, P<0.01); and the levels of TG and LDL-C were markedly higher than those in the fenofibrate group (P<0.05, P<0.01); HDL-C level was (1.10±0.13)mmol/L, which was markedly lower than that in the bezafibrate and fenofibrate groups(all P<0.05). There was no statistically significant difference in the indices between the two treatment groups (all P> 0.05). In the bezafibrate and fenofibrate groups, gastrointestinal symptoms occurred in 11 cases (18.6%) and 9 cases (16.4%), respectively; there was no statistically significant difference (P> 0.05); Transient elevation of ALT, AST, and CK levels occurred. There were no statistically significant differences in rash and some other adverse reactions between the two treatment groups (all P> 0.05). Conclusion: Homemade bezafibrate is a safe and effective lipidlowering agent.

  • 病例报告
    Gao Linan;Zhao Yinga;Wang Xinyuea;Shi Aixinb;Sun Fuchenga
    . 2009, 11(1): 67-2.
    Two female patients with rheumatic heart disease developed shock following infusion of amiodarone.The first patient, a 47yearold woman with rheumatic heart disease, received an IV infusion of amiodarone 150 mg diluted in 100 ml of glucose 5%. After about 70 ml of the infusion, the patient developed chest distress, restlessness; her blood pressure decreased to 59/32 mmHg and heart rate was 116 beats/min. Amiodarone was stopped. She was treated with IV dopamine 10 mg. Twenty minutes later, her blood pressure gradually returned to 100/70 mmHg and her heart rate was 110 beats/min.The second patient, a 62yearold woman with rheumatic heart disease, received an IV infusion of amiodarone 150 mg diluted in 100 ml of glucose 5%. After two minutes of the infusion, the patient developed numbness of her lips, chest distress, short breath, a feeling of fullness of the head. Amiodarone was withdrawn and changed to an infusion of sodium chloride 0.9%. Her symptoms were exacerbated. The patient presented with pale, cyanosis, restlessness; her blood pressure decreased to 50/0 mmHg and her heart rate was 140-170 beats/min. The patient was treated with IV dexamethasone 2 mg and IV dopamine 10 mg successively, and then an IV infusion of dopamine 20 mg diluted in 100 ml of sodium chloride 0.9%. Twenty minutes later, her blood pressure gradually returned to 90/50 mmHg and her heart rats was 118-160 beats/min. The patient's symptoms improved.
  • 病例报告
    Ji Fusheng;Xie Linjing
    . 2008, 10(2): 145-2.

    A 55yearold alcoholic man with pulmonary tuberculosis received oral isoniazide 0.3 g/d, rifapentine 0.45 g/d twice weekly, pyrazinamide 1.5 g/d. Three weeks later, the patient experienced hypodynamia, anorexia, dark urine, yellowish of skin and sclera, and ascites. Laboratory investigations revealed the following values: ALT 178.9 U/L, AST 85.7 U/L, TBiL 136.4 μmol/L, DBiL 134 μmol/L. Serologic tests for hepatitis A, B, C, D, and E were negative. The patient was given liverprotective and symptomatic treatment. Twelve days later, his symptoms improved and his liver function returned to normal ranges.

  • 药物滥用
    Zhang Kaigao
    . 2009, 11(2): 117-3.
    Opioid abuse can cause dependence and addiction accompanied by neurological impairment. Opioid neurotoxicity is associated with opioidinduced neuronal oxidative stress, apoptosis, and inhibition of neurogenesis in the brain. Understanding the mechanisms of opioid neurotoxicity may benefit to improve the treatment of opioid addition.
  • 系列问答
    . 2009, 11(2): 150-1.
  • 病例报告
    Xie Xiaoju;Sun Jing
    . 2008, 10(5): 0-0.

    A 75-year-old woman was administered with an IV infusion of gatifloxacin 0.4 g dissolved in 500 ml of glucose 5% after undergoing cholecystectomy. On the second day, she presented with visual illusion, hallucination, excitement, restlessness, and persecutory delusion about five hours and a half after the infusion. Twelve hours later, her symptoms gradually resolved. On the third day, gatifolxacin was discontinued and her psychiatric symptoms did not reappear.

  • 论著
    Xu Chuanjin;Zhang Wenzhong;Kong Suli;Cai Shanglang
    . 2008, 10(5): 0-0.

    Objective: To study the effects of the low-osmolality nonionic contrast media iopromide on renal function in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). Methods: One hundred and fifty-eight patients with ACS undergoing PCI were divided into two groups: the normal renal function group (88 cases) and the mild renal dysfunction group (70 cases, serum creatinine levels 120.45~232.5 μmol/L). Blood urea nitrogen (BUN) and serum creatinine (SCr) levels were measured before PCI and 24 hours, 48 hours, and 7 days after PCI. Results: The BUN levels before PCI and 24 hours, 48 hours, and 7 days after PCI in the normal renal function group were (5.45±1.65)mmol/L, (5.60±1.58)mmol/L, (5.55±1.70)mmol/L, and (5.48±1.81)mmol/L, respectively. There was no statistically significant difference in BUN levels before and after PCI (P>0.05). The BUN levels before PCI and 24 hours, 48 hours, and 7 days after PCI in the mild renal dysfunction group were (7.83±3.14) mmol/L, (8.43±3.37) mmol/L, (8.76±2.97) mmol/L,and (8.11±3.18)mmol/L, respectively; no statistically significant difference was observed in BUN levels before and after PCI (P>0.05). The SCr levels before PCI and 24 hours and 48 hours after PCI in the normal renal function group were (82.54±23.57)μmol/L, (85.48±22.47)μmol/L, and (86.51±21.72)μmol/L, respectively. The SCr levels before PCI and 24 hours and 48 hours after PCI in the mild renal dysfunction group were (176.25±28.47)μmol/L, (181.71±25.54)μmol/L, and (187.34±27.46)μmol/L, respectively. The difference in SCr levels before and after PCI was not significant between both groups (P>0.05). The renal function returned to the preoperative level 7 days after PCI. Conclusion: Low-osmolality nonionic contrast media iopromide has no marked effects on renal function in patients with ACS undergoing PCI.

  • 病例报告
    . 2004, 6(5): 330-330.
    A 21-year-old woman experienced serious pain on left renal area the previous night, and diagnosed as spasm of the ureter. The patient was treated with nifedipine 10mg three times and ofloxacin 0.2g twice daily in clinic. She complained of urinary frequency at night, without other discomforts after the medication. So no treatment was started and only the outflow and frequency of urine were observed. 5 days later, her urinary outflow was 100-300ml a time, 7-10 times a day, including 3-5 times at night. Nifedipine was discontinued while ofloxacin was continued. The frequent micturition was decreased obviously, and resolved in the evening.
  • 国外文献题录
    . 2002, 4(2): 132-134.
  • 综述
    . 2002, 4(5): 289-292.
    本文从评价抗高血压药物疗效的传统指标的局限性出发,引入生命质量的概念及其作为评价药物疗效的新指标的价值,并概述了生命质量评价在四种主要抗高血压药物疗效评价中的应用。
  • 病例报告
    . 2005, 7(6): 449-449.
  • 监测简报
    . 2003, 5(6): 410-411.
  • 病例报告
    . 2000, 2(2): 129-129.
  • 病例报道
    . 1999, 1(1): 49-49.
  • 中毒救治
    . 2002, 4(2): 107-110.
  • YANG Ji-hong;SONG Qi-wen;ZHENG Zhi-chang;SUN Wei-min;CHENG Ming-liang
    . 2013, 15(6): 320-5.
    ObjectiveTo analyze existing problems and countermeasures during the reporting work of hospital adverse drug reaction(ADR).MethodsADR reports which were reported by Affiliated Hospital of Guiyang Medical College during the period from January 2008 to December 2012 and received by National Center for ADR Monitoring were collected. Analysis was made to see whether these ADR reports could meet the requirement of “An ADR case” published by National Health and Family Planning Commission in 2011. The monitoring period of drug (new drugs) and outside monitoring period of drug (older drugs) were calculated on approval number respectively listing <5 and ≥5 years.ResultsFour hundred and eighty-five ADR reports were collected. Of them, 242 cases (49.9%) were received from 2012 and 243 cases (50.1%) were received from 2008 to 2011. Significantly increasing ADR reports in number was associated with the implementation of ADR reporting quantitative measures in Guiyang since 2012. Of the 485 ADR reports, there were 107 cases (22.1%) in accordance with the reporting requirement including 22 cases caused by new drugs and 85 cases of new and serious ADR caused by old drugs. The 22 cases caused by new drugs, involving 18 kinds of new drugs, included 5 cases of serious ADR reports and 17 cases of general ADR reports. Old drug-induced ADR reports were 463 cases involving 384 kinds of drugs and, of them, there were 85 cases (18.4%) in accordance with the reporting requirement including 9 cases of new ADR reports and 76 cases of serious ADR reports.ConclusionsThe main existing problem during the reporting work of hospital ADR is low quality of ADR reports. Implementation of ADR reporting quantitative measures played a limited role in improving the reports quality. Subdividing the definition of ADR, making reporting scope clear, perfecting reporting system, implementing feasible institution of new drugs monitoring, and improving reports quality and their usable value are suggested.
  • 病例报告
    Zhang Na
    . 2011, 13(1): 48-1.
    A 75-year-old man received an IV infusion of ambroxol hydrochloride glucose injection 50 ml (containing ambroxol hydrochloride 30 mg and glucose 2.5 g) for pulmonary infection. About 30 minutes later, the patient abruptly experienced chest distress, cold sweat, nausea, and dizziness. Physical examination showed a blood pressure of 40/0 mm Hg, cyanosis, pale face, cold extremities, and confusion. The intravenous infusion was stopped immediately. He underwent electrocardiogram monitoring and received oxygen inhalation therapy, dexamethasone, promethazine, and dopamine. His blood pressure became stable and was 130/70 mm Hg 4 hours later. His other vital signs were normal, and his symptoms disappeared. During a twoweek hospitalization, intravenous infusion of ambroxol hydrochloride was not readministered and similar symptoms did not recur.
  • Zhang Shengyu;Wang Xia;Jiang Ling;Shi Tianlu
    . 2015, 17(1): 66-2.
    A 25-year-old man with chronic renal insufficiency received oral alfacalcidol 0.5 μg every night, compound α-Ketoacid 2.52 g thrice daily, Shengxuening (生血宁) 0.5 g thrice daily, and subcutaneous injection recombinant human erythropoietin 2500 U once every other day. On day 15, laboratory tests showed the following results: alanine aminotransferase (ALT) 411 U/L,aspartate aminotransferase (AST) 341 U/L. He was given an IV infusion of reduced glutathione 1.2 g once daily. The next day, aminotransferase levels continue to increase, combined with an IV infusion of polyene phosphatidylcholine 465 mg once daily. On day 20, his liver function reexamination showed the following levels: ALT 1 768 U/L, AST 1 164 U/L, alkaline phosphatase 338 U/L, gamma-glutamyl transferase (γ-GT) 210 U/L. The alfacalcidol was stopped at that day and other drugs were continued. Three days after withdrawal, the levels of ALT, AST, and γ-GT were 644 U/L, 206 U/L, and 254 U/L, respectively. Fourteen days later, the level of ALT and AST decreased to 47 U/L and 58 U/L.
  • . 2015, 17(3): 240.
  • 论著
    Long Liang;Li Lulu;Yan Min;Yin Tao
    . 2014, 16(2): 91-4.
    ObjectiveTo explore the occurrence and related factors of kidney injury induced by tacrolimus in elderly patients.MethodsThe clinical data of patients who were hospitalized in Xiangya Hospital during December 2011 to October 2013 and had complete medical records, aged≥60 years, and received tacrolimus treatments were collected and analyzed retrospectively. The main analytic indicators included the change of serum creatinine before and after tacrolimus treatment, the blood trough concentration of tacrolimus, and the drug combinations. The tacrolimus trough concentration >15.0 μg/L was considered as a positive result and the positive rates after tacrolimus treatment in patients in the renal damage and the no renal damage groups were compared.ResultsA total of 127 patients were enrolled in this study. There were 11(8.7%)patients in the renal damage group and 116 patients in the no renal damage group. It comprised 6 men with age of 61 to 80 (69±11) years, and 5 women with age of 60 to 85 (69±11) years in the renal damage group; while it comprised 64 men with age of 60 to 89 (74±9) years, and 52 women with age of 60 to 85 (70±6) years in the no renal damage group. There were no statistical significance in gender and age distribution in patients between the 2 groups (P>0.05). The serum creatinine levels before tacrolimus treatment were 57-363 (179±90) μmol/L in patients in the renal damage group and 42-350 (150±65) μmol/L in patients in the no renal damage group. The difference was no statistical significance between the 2 groups (P>0.05). The serum creatinine levels increased to 176-639 (358±183) μmol/L after 5 to 20 (11±6) days receiving tacrolimus treatments in patients in the renal damage group. The difference before and after treatment was statistically significant (P<0.05). The blood trough concentration of tacrolimus was 5.9-15.1 μg/L in 11 patients in the renal damage group and >15.0 μg/L (81.8%) in 9 of them; the tacrolimus trough concentration was 4.7-16.9 μg/L in 116 patients in the no renal damage group and >15.0 μg/L (36.2%) in 42 of them. The difference between the 2 groups was statistically significant (P=0.00). Eleven patients with renal damage were treated with cytochrome P450 3A inducers/inhibitors combined with glucocorticoid; 3 of them combined with nephrotoxic drug at the same time. When the kidney injury appeared in the 11 patients, tacrolimus was stopped immediately and changed to other immunosuppressants in 9 patients and the drug dosages were adjusted in 2 patients. No irreversible kidney injury occurred in any of the patients.ConclusionTacrolimus may induce renal damage in elderly patients, which may be related to the blood trough concentration of tacrolimus as well as potential interactions among combined drugs.
  • Chang Liuyi, Zu Xiuhong, Luan Zhonghua, Wang Weimin
    Adverse Drug Reactions Journal. 2023, 25(2): 117-120. https://doi.org/10.3760/cma.j.cn114015-20220414-00322
    A 77-year-old male patient received amiodarone 0.2 g twice daily orally for arrhy- thmia. After 15 months of amiodarone treatment, he developed some symptoms such as poor appetite, reduced diet, nausea and vomiting, and dysphagia. After 22 months of amiodarone treatment, laboratory tests showed white blood cell count 13.5×109/L, neutrophil 0.78, C-reactive protein 117.4-mg/L, erythrocyte sedimentation rate 32-mm/1 h, alanine aminotransferase (ALT) 286-U/L, aspartate aminotransferase (AST) 215-U/L, alkaline phosphatase (ALP) 107-U/L, γ-glutamyl transferase (γ-GT) 45-U/L, total bilirubin (TBil) 14.8-μmol/L, direct bilirubin 9.3-μmol/L, and albumin 30-g/L. After treatments with anti-infection, hepatoprotection, and albumin supplementation, the above symptoms were improved and amiodarone was continued. After 40 months of amiodarone treatment, laboratory tests showed ALT 87-U/L, AST 106 U/L, ALP 308-U/L, γ-GT 1-242 U/L, and TBil 11.2-μmol/L. According to the results of liver biopsy, it is suspected that the patient was alcoholic liver fibrosis. After excluding alcoholic liver disease, viral hepatitis, autoimmune liver disease, and tumors by imaging and liver biopsy, it was considered to be associated with long-term use of amiodarone. Amiodarone was withdrawn, but the patient died 3 months later because of ascites and jaundice.
  • 论著
    Chen Qian;Liang Beibei;Li Yue;Niu Hui;Di Xiuzhen;Chu Xiaomeng;Bai Yan;Wen Ke;Liu Xu;Wang Jin;Wang Rui
    . 2014, 16(2): 95-5.

    ObjectiveTo investigate the research progress in nephrotoxicity due to polymyxin and provide a reference for clinical safe use of polymyxin.Methods“Polymyxin”, “colistin”, “colistimethate”,“nephrotoxicity”, and “renal toxicity” were selected as the keywords and PubMed, Embase, Web of Science, Chinese Medical Citation Index, and Chinese BioMedical Disc were searched. All literature about nephrotoxicity due to polymyxin were enrolled. The evaluated databases of literature accepted for bibliometric study were establish by Microsoft Excel. The parameters of bibliometrics such as literature′s language, literature′s type, publication date, the countries and institutes ranking in the top 5 in publishing, top 5 journals in publishing number, and top 10 most frequently cited articles. The main content and hotspot of literature were analyzed. The clinical manifestations, mechanism, and prophylactico-therapeutic measures of nephrotoxicity due to polymyxin were summarized.ResultsA total of 95 articles (90 in English, 3 in Chinese, 1 in French and 1 in Portuguese) were enrolled in the study, of which 82 were original articles and 13 were reviews. The published time of first original publication of nephrotoxicity due to polymyxin was in 1952. The countries ranking in the top 5 in publishing were United States (29 pieces), Greece (12 pieces), Turkey (8 pieces), Australia (6 pieces), and Korea (5 pieces), respectively. The highest citation rate of article was 156 times. The mode of administration of polymyxin were intravenous infusion and nebulized inhalation. Kidney injury due to polymyxin usually occurred in 4-10 days after administration. The main clinical manifestations were myodynia, weakness, dark urine, hematuria, and proteinuria. Laboratory examination showed elevated serum creatinine and depressed creatinine clearance rate. After the drug withdrawal and supportive treatments, some patients′ renal functions returned to the levels before administration. The incidence of nephrotoxicity due to polymyxin elevated following the increase of dosage and decreased following the lengthening of dosing interval. The mechanism of nephrotoxicity due to polymyxin was unknown, it may be related to the increase of membrane permeability and the change of transmembrane potential of ureteric epithelial cells.ConclusionsGreece is ranked at the leading position in the research of nephrotoxicity due to polymyxin. The researchers pay more attention to the high-qulity articles. The degree of nephrotoxicity due to polymyxin can be alleviated by decreasing dose, extending the dosing interval, and combined use of kidney-protective drugs. Once kidney injury due to polymyxin occurred, the drug withdrawal and supportive treatments should be given immediately.

  • 病例报告
    Zhou Xuan;Lu Min
    . 2014, 16(2): 122-2.

    A 57-year-old woman with postoperative infection of rectal melanoma received an IV infusion of levofloxacin 0.2 g/100 ml twice daily. She developed weakness, hyperhidrosis, and palpitation 20 minutes after IV infusion. Laboratory examination showed that blood glucose was 2.7 mmol/L. Levofloxacin was discontinued immediately. She was given an IV infusion of 10% glucose 500 ml and candy. Her symptoms were mitigated. She was given an IV infusion of levofloxacin injection on the next day. The symptoms mentioned above recurred 10 minutes later. Laboratory examination showed blood glucose was 2.8 mmol/L. Levofloxacin was discontinued immediately and the symptomatic treatment was given again. Her hypoglycemia symptoms relieved. After switching to other antibiotics, her infection was under control and the hypoglycemic reaction did not occur again.

  • 病例报告
    Lan Anjie;Liu Lihong;Luo Jing;Wang Dan;Gao Wenjing
    . 2011, 13(4): 249-2.

    A 20-year-old man with heart failure received an Ⅳ infusion of deslanoside

    0.4 mg twice daily, a slow intravenous injection of amiodarone 75 mg and then a continuous

    infusion of 1 mg/min via a pump, and furosemide 20 mg once daily. On day 3 of treatment, he

    developed obnubilation and somnolence, his blood pressure was 78/36 mm Hg. Dopamine,

    nikethamide, lobeline were given immediately, meanwhile he was placed on a respirator for

    assisted respiration. On the same day, his blood digoxin level reached 7.3 μg/L.

    Deslanoside, amiodarone, and furosemide were stopped, nasal administration of phenytoin

    sodium 0.1 g was given three times daily. On day 5, his blood digoxin level decreased to

    0.82 μg/L.

  • 论著
    ANG Ke-xu;LIN Yang;LIU Wen-fang;LI Jing;SUO Wei;WU Wei;QIU Qi;DU Hai-yan;ZHOU Zi-jie;ZHAO Gui-ping;WANG Yun-long;PAN Yu;YAN Xiu-juan;JIA Xiao-xin
    . 2012, 14(5): 282-4.
    ObjectiveTo study pharmacokinetic and pharmacodynamic characteristics of homemade bivalirudin in healthy male subjects and evaluate its safety preliminarily in order to provide the scientific basis for a phase Ⅱ/Ⅲ clinical trial and clinical use of the drug. Methods Healthy male subjects were collected and received a single intravenous bolus injection of bivalirudin 0.75 mg/kg. Plasma concentrations of bivalirudin within 180 min after injection were determined by liquid chromatography-tandem mass spectrometric (LC-MS/MS) method for pharmacokinetic analysis. The activated clotting time were measured for pharmacodynamic analysis. At the same time, the vital signs and safety evaluation indexes were observed in all subjects before and after medication. ResultsTen healthy male subjects were entered. Their age, height, weight, and body mass index were (29.5±3.4) years, (1707±5.5) cm, (66±7) kg, and (22.2±1.7) kg/m2, respectively. The pharmacokinetic parameters were as follows: peak concentration (Cmax) (8347±1586) μg/L, peak time (Tmax) 5 min, elimination half-life (T1/2z)(41.6±9.0) min, area under the curve (AUC0-t)1240 (98.4-182.3) min·μg/L, area under the curve (AUC0-∞)(131.9±26.8) min·μg/L,mean retention time (MRT0-t)(25.6±31) min, volume of distribution (Vz) (354.8±103.9) ml/kg, clearance (CL)(5.9±1.1)ml/(min·kg). The pharmacodynamic parameters were as follows: basic effect (E0)(146±17) s,concentration for 50% of maximal effect (EC50)2225 (799-42 008) μg/L,maximal effect (Emax)(4072±294) s. No changes in X-ray, cranial CT, 12-lead ECG and laboratory examination (routine blood and urine tests, blood biochemical tests, immunological tests, 5 tests of coagulation) were observed after the trail. No adverse drug reaction occurred during the trial. ConclusionHomemade bivalirudin seems to have the characteristics of rapid onset of action and shorter half-life and might be used as a safer anticoagulant in patients undergoing percutaneous coronary intervention.
  • 病例报告
    . 1999, 1(3): 164-164.
  • 论著
    Du Biao①②;Xiang Zhiguo②
    . 2007, 9(2): 91-94.
    Objective: To observe the efficacy and safety of aripiprazole used for treating patients with senile schizophrenia. Methods: Seventy patients with senile schizophrenia were randomly divided into following two groups: aripiprazole group [17 males, 18 females, age(66.2±2.4) years] and haloperidol group [18 males, 17 females, age(65.4±2.4) years].The initial dosages for the aripiprazole and haloperidol groups were 510 mg/d and 2 mg/d respectively, and then adjusted to (12.8±3.3) mg/d and (7.3±3.6) mg/d respectively according to the condition of disease. The duration of therapy was 8 weeks. PANSS was used to assess the clinical efficacy, and TESS was used to assess adverse reactions. Results: The effective rate in the aripiprazole and haloperidol groups was 88.6% and 85.7% respectively. There were no stastistically deferences between the two groups (P>0.05). The adverse reactions of aripiprazole were mild and less. Conclusion:Aripiprazole is an effective and safe drug used for treating patients with senile schizophrenia.
  • 专题讲座
    . 2002, 4(6): 396-399.
  • 监测简报
    . 2004, 6(3): 191-193.
  • 病例报告
    . 2005, 7(2): 90-90.
  • 病例报告
    . 2000, 2(3): 192-192.
  • 专题讲座
    . 2000, 2(3): 205-209.
  • 调查研究
    Lin Xin;Zhang Liming;Zhang Jun;Zhou Bing;Zhan Siyan
    . 2008, 10(2): 89-5.

    Objective: To investigate the present condition of professional structure and expertise of the staffs in five adverse drug reaction (ADR) monitoring centres at provincial level in order to provide scientific basis of human resources for developing intensive medicine monitoring programme and improving ADR monitoring system. Methods: The information relative to the staffs in the five centers was investigated and collected with selfquestionnaire and qualitative interview, including the personal information, ability of monitoring and research, and expertise level. Results: Fiftythree staffs in the five centers were investigated. The number of valid questionnaires was fiftytwo.The average age was (35±8) years. The ratio of male to female was 0.93∶1. The staffs with high or middle professional title were 53.9%. The percentages of doctor, master, and bachelor were 7.7%, 32.7%, and 51.9%, respectively. The percentages of clinical medicine, pharmacy, public health, computer, and statistics, were 46.1%, 21.1%, 58%, 3.8%, and 1.9%,respectively. Most staffs lacked epidemiological and statistical knowledge. Conclusion: The professional structure and expertise of the staffs in the five ADR monitoring centres at provincial level were equal to the task of ADR monitoring. However, the centres should be staffed with some specialists of public health, statistics, and computer, and some staffs should be trained with abovementioned expertise in order to benefit the development of intensive medicine monitoring programme and improvement of ADR monitoring reporting system.

  • 病例报告
    Huang Zhihu;Chen Baoan;Ding Jiahua;Zhao Gang;Wang Jun;Liu Deliang
    . 2009, 11(2): 130-2.
    A 31yearold man received oral imatinib mesylate 400 mg once daily for chronic granulocytic leukemia. The patient had no previous history of heart disease or hypertension. An ECG and ultrasound revealed normal cardiac function before treatment. On day 1 of therapy, he experienced precordial discomfort. On day 6, he developed arrhythmia and atrioventricular block Ⅲ, his heart rate was 45 beats/min. Imatinib mesylate was discontinued. He received supportive treatment and a temporary pacemaker. His symptoms improved.
  • 病例报告
    Cao Yuean;Peng Chaosheng;Long Nanzhan
    . 2009, 11(1): 58-2.
    A 52yearold man with hypertension, who had been receiving oral valsartan 80 mg daily for six years or more, underwent intracoronary stent implantation for coronary atherosclerosis. Clopidogrel tablets 75 mg/day, aspirin entericcoated tablets 100 mg/day, isosorbide mononitrate sustainedrelease tablets 40 mg/day, and atorvastatin calcium tablets 10 mg/day were given after surgery. Approximately one month later, bisoprolol 5 mg/day was added to his regimen due to palpitation. After 3 days of treatment, the man developed dry cough. His routine blood test, chest Xray, and echocardiography were normal. Symptomatic treatment showed no marked effect. Bisoprolol was discontinued and his cough improved three days later. Five months later, the patient restarted receiving bisoprolol due to palpitation, and his cough reappeared. Codeine was given, but this had no effect on his congh. Bisoprolol was stopped again. One week later, his symptom diappeared.
  • 病例报告
    Liu Hui;Sun Fenggang
    . 2008, 10(2): 141-2.

    A 47yearold woman with urinary infection received oral moxifloxacin hydrochloride 400 mg. Two to three hours later, the woman developed nausea and hyperhidrosis, and 5~6 hours later, she developed visual hallucinations with seeing people and animals. The visions lasted for about 3 hours. The next day, the visual hallucinations reappeared 2 hours after repeated exposure to the same dose of moxifloxacin. Her EEG showed more rhythm with β fast wave. Moxifloxacin was discontinued, and she was given symptomatic therapy. The symptoms disappeared. At followup after half a year, there were no neurological symptoms and signs, and her EEG was basically normal.

  • 病例报告
    Zhu Man;Sun Yan
    . 2008, 10(3): 167-2.

    Patient 1, an 80yearold woman underwent resection of bullas of the right lung and fixation of pleural friction received intravenous infusion of fat emulsion for seven consecutive weeks. Later, her TBil, DBil, and TG levels increased from 12.5 μmol/L, 3.3 μmol/L and 0.95 mmol/L to 141.5 μmol/L, 104.3 μmol/L, and 13.64 mmol/L, respectively; her PLT decreased from 189×109/L to 48×109/L. After stopping fat emulsion, her TBil, DBil, and TG levels were 46.2 μmol/L, 33.1 μmol/L, and 2.50 mmol/L, respectively; her PLT was 51×109/L. And ten day later, the patient died of circulatory and respiratory failure.Patient 2, an 89yearold man with pulmonary infection, left pneumothorax, and waterelectrolyte disturbances received intravenous infusion of fat emulsion for three consecutive weeks. Later, his TBil, DBil, and TG levels increased from 9.5 μmol/L, 4.1 μmol/L, and 1.03 mmol/L to 210.8 μmol/L, 182.1 μmol/L, and 13.96 mmol/L, respectively; his PLT level decreased from 242×109/L to 128×109/L. After stopping fat emulsion infusion, his TBil, DBil, TG and PLT level were 152.4 μmol/L, 89.3 μmol/L, 5.32 mmol/L, and 88×109/L, respectively. The patient died of multiorgan failure.

  • 安全用药
    . 2002, 4(4): 235-237.
    本文通过对320例口服头孢拉定住院患者的临床观察,以探讨头孢拉定临床用药的安全性与合理性。320例患者中,发生不良反应11例,发生率为3.44%。不良反应的发生与年龄、不合理用药有关。其中60岁以上的老年人7例,占全部不良反应的63.64%;12岁以下的儿童3例,占全部不良反应的27.27%。320例中,头孢拉定不合理用药22例,占6.88%,其中60岁以上的老年人15例,主要问题为用药时间过长。结果提示,头孢拉定在临床上应用是安全的,但要注意合理用药,老年患者慎用。
  • 病例报告
    . 2006, 8(3): 210-210.
  • 病例报告
    . 2006, 8(3): 215-215.
  • 病例报告
    . 2002, 4(1): 45-45.
  • 病例报告
    . 2001, 3(3): 195-195.
  • 病例报告
    . 2005, 7(5): 371-371.
  • 病例报告
    . 2004, 6(3): 183-184.
  • 病例报告
    HU Yang;WANG Lan;ZHANG Bo;MEI Dan;LI Da-kui
    . 2012, 14(6): 382-3.
    A 29-year-old male patient with Crohn disease received an IV infusion of infliximab 300 mg. On day 4 after the first administration, his routine blood tests showed the following levels: white blood cell count 4.63×109/L, neutrophil count 2.39×109/L, hemoglobin 144 g/L, platelet count 138×109/L. On day 25 after the second administration, he developed pinhead-sized purple petechiae on his skin. Laboratory tests showed the following levels: white blood cell count 2.07×109/L, hemoglobin 109 g/L, platelet count 10×109/L. He received recombinant human granulocyte colony-stimulating factor, recombinant human thrombopoietin and intermittent blood transfusion, but blood cell count fell progressively. Aplastic anemia was diagnosed according to bone marrow smear and bone marrow biopsy. And then he was treated with meropenem, hydrocortisone, erythropoietin, ciclosporin, stanozolol, rabbit anti-human thymocyte immunoglobulin, and ganciclovir. About 2 months later, reexamination showed the following findings: white blood cell count 2.06×109/L, neutrophil count 1.62×109/L, red blood cell count 2.51×1012/L, hemoglobin 73 g/L, and platelet count 24×109/L. He was discharged and continued receiving ciclosporin treatment. The patient developed fever on the second day. After 7 days, purplish red petechiae scattered on his upper limbs and back. He was hospitalized again. Routine blood tests showed white blood cell count 4.59×109/L, neutrophil count 3.80 ×109/L, red blood cell count 2.45×1012/L, hemoglobin 74 g/L, and platelet count 56×109/L. Severe aplastic anemia was diagnosed. The patient finally died from severe anemia (his hemoglobin level decreasing to 38 g/L), severe infection and hemorrhage despite resuscitation attempts.
  • 论著
    WANG Hai-yan;CHEN Yan-mei;WANG Hu-jun
    . 2012, 14(2): 69-4.

    ObjectiveTo evaluate the efficacy and safety of isepamicin in the treatment of patients with advanced age and severe infection caused by Gram negative bacilli. Methods From March 2008 to December 2010, the clinical data of treatment with isepamicin in the patients with advanced age and severe infection caused by Gram negative bacilli in the Military General Hospital of Beijing PLA was collected and analyzed with retrospective method. An IV infusion of isepamicin 200-400 mg once daily was given. The treatment course was 3-7 days. The major indexes were effective rate, pathogens clearance rate, peripheral white blood cell count (the proportion of neutrophils) before and after the treatment, renal function, and the incidence of adverse reactions after isepamicin treatment. ResultsA total of 33 patients were collected. Of them, 31 were men and 2 were women with average age of (93±4) years (from 80 to 100). Thirty-one patients had lung infections, 2 patients had urinary system infections. The main pathogens in patients were Pseudomonas aeruginosa. All patients were treated with isepamicin alone or in combination with other drugs due to the poor treatment outcome in clinical practice and appearance of resistant Gram negative bacilli during bacterial culture. After 3-10 days of treatment, the effective rate was 97.0% (32/33); bacterial clearance rate was 90.9% (30/33); the peripheral white blood cell count and the proportion of neutrophils were (14.0±4.2)×109/L and 0.81±0.06 before treatment, (11.0±3.3)×109/L and 0.74±0.08 after treatment, respectively; the differences were statistically significant (both P=0.00). There were no significant differences before and after the treatment in the levels of creatinine and urea nitrogen (P>0.05). During the treatment, 19 patients’urine volume decreased and returned to normal 2-3 days after drug discontinuation. No other adverse reactions were observed. ConclusioIsepamicin treatment in combination with other antimicrobials is effective in patients older than 80 years of age with severe infection caused by Gram negative bacilli. Application of isepamicin is safe under strict control of drug indications, dosage, administration, treatment course, and regular monitoring.

  • LI Fang;MA Ping;LAN An-jie;LI Cheng-min;LIU Xiao-hui;TONG Wei-hang
    . 2013, 15(5): 290-2.
    A 25-year-old male patient with upper abdominal pain for 3 hours received combination treatment with famotidine tablets 20 mg twice daily and 2 roter tablets thrice daily. After 2 days of treatment,his upper abdominal pain became worse than before, liver function tests showed the following levels: alanine aminotransferase (ALT)178 U/L. Then he received an IV infusion of famotidine 20 mg and glucurolactone 266 mg twice daily. On day 2 of hospitalization, liver function tests showed the following levels: ALT133 U/L, aspartate aminotransferase (AST) 63 U/L, γ-glutamyl transferase (γ-GT)162 U/L;on day 8 of hospitalization, repeat liver function tests revealed the following levels:ALT 414 U/L, AST 134 U/L, γ-GT 714 U/L, alkaline phosphatase 161 U/L, total bilirubin (TBil) 15.2 μmol/L, direct bilirubin (DBil) 9.7 μmol/L, so it was considered that the liver damage may be associated with famotidine, then famotidine was discontinued immediately and switched to an IV infusion of pantoprazole sodium 40 mg in 0.9% sodium chloride 100 ml twice daily. An IV infusion of reduced glutathione 1.8 g and compound glycyrrhizin 160 mg in 5%glucose 250 ml once daily was given. Five days after famotidine withdrawal, repeat liver function tests revealed the following levels:ALT 62 U/L, γ-GT 315 U/L, TBil 13.1 μmol/L, DBil 6.2 μmol/L. A week later, his liver function tests revealed the following levels:ALT 28 U/L, AST 31 U/L.
  • GAO Yang;JIA Liu;YU Kai-jiang
    . 2013, 15(5): 294-2.
    A 14-year-old female patient took Polygoni Multiflori Radix Praeparata and Tribuli Fructus decoction for vitiligo (dose not stated). Thirty-eight days later, she developed yellowish sclera and skin. She appeared disturbance of consciousness after 42 days. Laboratory tests revealed the following results: white blood cell count 13.8×109/L, prothrombin time 27.6 s, prothrombin activity 24%, activated partial thromboplastin time 75.7 s, fibrinogen 1.08 g/L, alanine aminotransferase 510 U/L, aspartate aminotransferase 254 U/L, total bilirubin 395.7 μmol/L, direct bilirubin 319.4 μmol/L, ammonia 65 μmol/L, and urine bilirubin +++. Drug-induced liver injury, acute liver failure, and hepatic encepha-lopathy were diagnosed. She was treated with glutathione, ademetionine 1,4-butanedisulfonate, compound amino acid, naloxone hydrochloride, Xingnaojing (醒脑静), aceglutamide, diisopropylamine dichloroace-tate, polyene phosphatidylcholine, ornithine aspartate, omeprazole sodium and mannitol by intravenous infusion, nasal feeding lactulose oral solution, intermittent infusion of fresh frozen plasma and plasma exchange. On day 5, the patient′s liver function improved and consciousness was restored. On day 16, she recovered well.
  • 论著
    QIN Xiu-chuan;WANG Chun-mei;SUO Min;WEN Bo
    . 2013, 15(1): 33-5.

    ObjectiveTo study the effects of intracoronary pre-injection of tirofiban before primary percutaneous coronary intervention (PPCI) on coronary forward blood flow and myocardial tissue perfusion in patients with acute ST-segment elevation myocardial infarction(STEMI). MethodsThe STEMI patients who were scheduled for PPCI from January 2010 to December 2011 in Beijing Anzhen Hospital were enrolled in the study as the subjects and were divided into the tirofiban group and the control group by random number table. The patients in both groups chewed aspirin 300mg and clopidogrel 300-600 mg before coronary angiography, and received heparin at the standard dosage (100 U/kg)during the operation. The patients in the tirofiban group were given a slow IV push of tirofiban(10 μg/kg)within three minutes through a guiding catheter after coronary angiography, followed by a continuous IV infusion of tirofiban 0.15 μg/kg per minute for 36 hours via a mini pump, while the patients in the control group did not received any drugs. The patients in both groups received the same routine anticoagulant treatment after PPCI. The data including baseline characteristics of patients features of coronary angiogram, clinical prognosis,incidences of mild, moderate and severe hemorrhage, thrombocytopenia and in hospital mortality were collected and compared between the 2 groups. The efficacy and safety of intracoronary pre-injection of tirofiban were analyzed.ResultsA total of 737 patients enrolled in the study. There were 324 patiens in the tirofiban group comprising 233 male and 91 female with average age of (62±10)years. There were 413 patients in the control group comprising 301 male and 112 female with average age of (60±11)years. The differences in sex and age distribution, cases complicated with hypertension and diabetes mellitus, smoking status, percentage of anterior myocardial infarction, the time from disease onset to treatment, the percentage of patients with thrombolysis in myocardial infarction (TIMI) grade 0 flow before PPCI, utilization rate of thrombus aspiration catheter during PPCI, incidence of moderate hemorrhage and thrombocytopenia between the 2 groups were not statistically significant (all P>0.05). No severe hemorrhage occurred in both groups. The percentage of patients with TIMI grade 3 flow after PPCI, percentage of grade 3 myocardial blush grade (MBG), rate of ST-segment decline and rate of mild hemorrhage were significantly higher in the tirofiban group than in the control group, they were 96.0%(311/324)vs 91.3%(377/413),92.3%(299/324)vs 87.2%(360/413),91.4%(296/324)vs 85.7%(354/413),6.8%(22/324)vs 2.7%(11/413), respectively, but the in hospital mortality was lower than that in the control group [0.9%(3/324)vs 3.1% (13/413)](all P<0.05). Logistic regression analysis indicated that intracoronary pre-injection of tirofiban was the independent factor affecting TIMI grade 3 flow after PPCI(OR=1.947,95%CI:1.156-4.022,P=0.036).ConclusionsIntracoronary pre-injection of tirofiban before PPCI may improve the coronary forward blood flow and myocardial tissue perfusion, and it may also increase the mild haemorrhage rate, but there is no need for clinical intervention. It has better efficacy and safety to patients with STEMI.

  • Wang Ling
    . 2016, 18(6): 451.
    A 15-year-old boy with intracranial infection received an IV infusion of piperacillin sodium and tazobactam sodium 4.5 g dissolved in 0.9% sodium chloride injection 100 ml, once per 6 hours. About six hours after IV infusion, the boy developed dark red rash which had pinpoint or rice grain size all over the body. Flaccid blisters were appeared on surface of part of the rash. His skin temperature gone up, combined with pruritus and tenderness pain obviously. His body temperature was between 37.4-37.7℃. The result of examination of  Nikolsky′s sign was positive. He was diagnosed as toxic epidermal necrolysis due to piperacillin sodium and tazobactam sodium. Piperacillin sodium and tazobactam sodium was stopped. The boy received the treatments of anti-infection, antianaphylaxis, and enteral nutrition, etc. Sixteen days later, the rash on his face, body, arms and legs faded away. The result of follow up by telephone one month later showed that there was no scar on the boy′s skin.
  • Hu Yemin, Huang liang, Wen Xianrong, Luo Hao
    Adverse Drug Reactions Journal. 2020, 22(11): 644-645. https://doi.org/10.3760/cma.j.cn114015-20200115-00050
    A 31-year-old female patient with schizophrenia got pregnant naturally during the treatment with clozapine (50-mg/d) and had been taking the drug during the pregnancy. Prenatal fetal ultrasound and chromosome examination showed no obvious abnormalities. The mother received subcutaneous injections of insulin aspart injection and insulin detemir injection and oral iron polysaccharide complex capsules for gestational diabetes mellitus and mild anemia successively during pregnancy. One live male infant was delivered by cesarean section at 39+2 weeks of gestation, with a birth weight of 3-280 g. The infant′s Apgar score was 10. Physical examination of the newborn showed scattered ecchymosis on limbs skin, pinpoint-like petechiae on whole-body skin, and arrhythmia by heart auscultation. Laboratory tests showed prothrombin time 14.4-s, activated partial thromboplastin time 69.4-s, thrombin time 22.9-s, fibrinogen 1.27-g/L, and platelet count 366×109/L. Neonatal coagulation dysfunction was diagnosed, which was considered to be possibly related to clozapine. Intravenous infusions of vitamin K1 injection and human fibrinogen were given. Four days later, ecchymosis and petechiae on his whole body were less than before, prothrombin time was 11.4-s, activated partial thromboplastin time was 45.0-s, thrombin time was 20.6-s, and fibrinogen was 2.22-g/L. Eight days later, his ecchymosis and petechiae basically disappeared.
  • Wang Lijun, Chen Bing, Zhang Peng, Jiang Yuyong, Cai Haodong
    Adverse Drug Reactions Journal. 2023, 25(9): 556-563. https://doi.org/10.3760/cma.j.cn114015-20230630-00485
    Objective To analyze and evaluate the decrease of anticoagulant effect of warfarin by herbal and dietary supplements (HDS) based on case report literature. Methods The case reports on decrease of anticoagulant effect of warfarin by HDS were selected by searching the relevant databases at home and abroad (up to June 24, 2023). The degree of decrease of anticoagulant effect of warfarin by HDS was evaluated according to the reduction degree of international normalized ratio and the occurrence of thrombotic events in patients in the case reports. The reliability scoring criteria of HDS-warfarin interaction was established according to the causality of the interaction between HDS and warfarin, the number of case reports, and the other evidences (warnings issued by relevant national institutions, clinical studies, pharmacokinetic/pharmacodynamic studies, animal studies, etc.). It was evaluated as highly, relatively, possibly, and suspiciously reliable if the total score was ≥9, 6-8, 3-5, and ≤2 points, respectively. Results A total of 17 case reports were enrolled in the analysis, involving 25 patients and 11 kinds of HDS. Two kinds of HDS reduced the anticoagulant effect of warfarin severely, including ginseng (Radix Ginseng)[(American ginseng (Radix Panacis Quinquefolii), red ginseng, etc.] and Myrrh; 5 kinds of HDS reduced the anticoagulant effect of warfarin moderately, including St. John′s wort (Hypericum perforatum L.), tea [green tea (Camellia sinensis), black tea], peppermint (Herba Menthae), coenzyme Q10, and chitosan; 4 kinds of HDS reduced the anticoagulant effect of warfarin slightly, including milkvetch root (Radix Astragali seu Hedysari), avocado, seaweed (Sargassum), and soya (Glycine max). The reliability of anticoagulant effect reduction of warfarin was evaluated as highly reliable in 1 kind of HDS, namely St. John′s wort (10 points), relatively reliable in 2 kinds of HDS, including ginseng and tea (8 and 6 points, respectively), possibly reliable in 7 kinds of HDS, including Myrrh, peppermint, coenzyme Q10, chitosan, milkvetch root, avocado, and seaweed (5, 5, 5, 4, 4, 4, and 3 points, respectively), and suspiciously reliable in 1 kind of HDS, namely soya (2 points). Conclusion The degree and reliability of anticoagulant effect reduction of warfarin by ginseng (American ginseng, red ginseng, etc.), St. John′s wort, and tea(green tea, black tea), are higher, which should be paid attention to by clinicians and clinical pharmacists.
  • Liu Jieli, Sun Ping, Zuo Ximeng, Yang Zhenrui, Wang Tangshun, Shi Xiaoguang
    Adverse Drug Reactions Journal. 2022, 24(4): 218-220. https://doi.org/10.3760/cma.j.cn114015-20211008-01034
    A 19-year-old female patient received risperidone 3-mg twice daily for schizophrenia. She did not have nipple discharge before taking the drug. After taking the drug, nipple discharge occurred intermittently. One year later, a mass with pain in the right breast was found, which could not be alleviated after treatments with Rupi Sanjie capsules (乳癖散结胶囊), cefdinir, ibuprofen, rifampicin, and isoniazid and continued to increase, accompanied by bilateral knee pain, nodular erythema and tenderness of lower limbs. Laboratory tests showed white blood cell count 18.4×109/L and serum prolactin 37.42-μg/L. Ultrasonography of the right breast showed a 13.2-cm×11.0-cm×3.0-cm area low echo with unclear boundary, local fluidity, and abundant blood flow signals around. Granulomatous lobular mastitis of right breast (abscess stage) and hyperprolactiemia was diagnosed. After excluding physiological and pathological reasons, it was considered that risperidone caused hyperprolactinemia, which then induced granulomatous mastitis. However, risperidone could not be stopped without the guidance of a specialist, so only abscess incision, drainage, debridement, anti-infection, and anti-inflammatory were given. Purulent secretions gradually decreased, pain alleviated, and erythema of lower limbs partially subsided. Then risperidone dose was adjusted to 2-mg twice daily under the guidance of her psychiatrist. The serum prolactin level decreased (28.36-μg/L). At 1 year of follow-up, granulomatous mastitis did not recur.
  • Xu Jinghang, Liang Rongyue, Yu Yanyan
    Adverse Drug Reactions Journal. 2020, 22(6): 366-372. https://doi.org/10.3760/cma.j.cn114015-20200516-00539
    Since the outbreak of novel coronavirus pneumonia (COVID-19), a number of clinical studies have been carried out globally in order to explore efficacy and safety of drugs for novel coronavirus (2019-nCoV). These studies were mainly focused on drugs with anti-2019-nCoV activity tested in vitro and those previously used for the treatment of SARS and Middle East respiratory syndrome, including remdesivir, lopinavir/ritonavir, chloroquine, hydroxychloroquine, arbidol, interferon, ribavirin, and etc. The recent clinical studies on anti-2019-nCoV drugs are reviewed in this article, but the current research results are inconsistent, which are insufficient to constitute evidence for the efficacy and safety of these drugs in the treatment of COVID-19. In the absence of specific antiviral agents, remdesivir can be a treatment option for patients with critical illness or rapid progress. Some clinical studies are still in progress. We are looking forward to more large-scale and multicenter clinical trials to provide safe and effective evidence for antiviral treatment in the future.
  • 论坛
    Ren Hong
    . 2014, 16(3): 129-3.
  • GUAN Nian-bo;JIA Cheng-hui
    . 2013, 15(3): 162-2.

    A 57-year-old male patient with pancreatic cancer received postoperative chemotherapy with an IV infusion of gemcitabine 1.6 g on days 1 and 8 combined with 3 capsules of tegafur, gimeracil and oteracil potassium orally (each capsule contains tegafur 20 mg, gimeracil 5.8 mg, and oteracil potassium 19.6 mg) twice daily on days 1-14 and one cycle took 21 days. On day 3 of drug use, the patient developed generalized burning pain and his highest temperature reached 39.6 ℃. Sporadic prunosus pruritus appeared in his limbs, chest, and back. Tegafur, gimeracil and oteracil potassium capsules were stopped immediately and gemcitabine was continued. On day 5 of drug use, the inside of his limbs, chest, and back were covered a large area of erythema multiforme, of which experienced vesicular in the center, red bulla fusing into lamella, and rupture and wound exposure, accompanied by erosive oral mucosa at the same time. Symptomatic treatments were given and, two weeks later, the rashes basically subsided. One week later, he received two cycles of combination chemotherapy with gemcitabine and fluorouracil and two cycles of capecitabine for chemotherapy as well and the rashes did not recur.

  • 病例报告
    Zu Xiaolin;Zhang Haibo;Zhu Xiaoling;Ma Linan
    . 2011, 13(3): 186-2.
    Patient 1, a 24-year-old man, received aspirin 300 mg, clopidogrel 300 mg, and an IV push of heparin 10 000 U ,then he underwent coronary arteriography, percutaneous transluminal angioplasty and stenting for acute myocardial infarction. His platelet count was 228.0×109/L before surgery. One hour after surgery, his platelet count decreased to 36.2×109/L. Heparin-induced thrombocytopenia was considered. Subsequently, heparin was discontinued, and an IV infusion of argatroban 0.5-2 μg·kg-1·min-1 was given. On day 3, the patients platelet count increased to 101×109/L and, on day 4, the platelet count returned to normal range.Patient 2, a 69-year-old man, with coronary atherosclerotic cardiopathy received an IV push of heparin 3000 U during coronary arteriography. Subsequently, he underwent coronary bypass. SC low-molecular-weight heparin 1 mg·kg-1·12 h-1 was given for 7 days before surgery and an IV infusion of heparin 7000 U was given during surgery. His platelet count was 197×109/L before surgery and decreased to 19.2 ×109/L after surgery. Heparin was stopped and an IV infusion of argatroban 0.5-1.5 μg·kg-1·min-1 was given. His platelet count increased to 146.0×109/L.
  • 论著
    HUANG Lu-fen;WANG Qing;DONG Yan;ZHOU Lian;WANG Pei-xun
    . 2012, 14(1): 20-6.

    ObjectiveTo explore the effect of traditional Chinese medicine injections (TCMI) on expression of immune cell surface molecules and provide reference for evaluating the allergenicity of TCMI. Methods Using a random block design, the female BALB/c mice were divided into the control group and 12 kinds of TCMI groups[the Yadanzi (鸦胆子), the Aidi (艾迪), the Xiangdan(香丹), the Gegensu(葛根素), the Honghua (红花), the Xingnaojing (醒脑静), the Xiyanping (喜炎平), the Shuxuening (舒血宁), the Yuxingcao (鱼腥草), the Shengmai (生脉), the Huangqi (黄芪), and the Dengzhanxixin (灯盏细辛) groups]. Each group comprised 7 mice. According to the equivalent dose used in the clinical practice, TCMI 50 μl was subcutaneously injected into the toe of left hind limb of each mouse in the TCMI groups, respectively. Equal volume of phosphate buffer solution was injected into the same site of each mouse in the control group. The mice were sacrificed on day 5 after injections, and the left popliteal fossa lymph node (PLN) was removed and the cell suspension were prepared. The ratio of CD4+ and CD8+ T cells, B cells, CD11c+ cells, F4/80 cells and the expression of early activation molecules CD69, MHCⅡ, co-stimulatory molecules CD86, CD80 and CD40 were detected using flow cytometry. Results Compared with the control group, the ratio of CD4+ T cells and the expression of CD69 molecule decreased in the Yadanzi group; the ratio of CD8+ T cells and the expression of CD69 molecule decreased in the Aidi group; however, the ratio of B cells increased and its expression of CD69 molecule decreased in the above-mentioned 2 groups;the ratio of the B cells increased and expression of CD69 molecule decreased in the Gegensu, Xiangdan and Xiyanping groups, the expression of CD69 molecule decreased in the T cells in the Gegensu group; the ratio of CD8+ T cells decreased in the Xiangdan and Xiyanping groups, the ratio of CD8+ T cells and the expression of CD69 molecule decreased in the Xingnaojing group; the expression of CD69 in the CD8+ T and B cells in the Yuxingcao and Dengzhanxixin groups, the ratio of CD8+ T cells decreased in the Honghua group. Compared with the control group, the ratio of CD11c+ and F4/80 cells increased in the Yadanzi, Aidi and Xiangdan groups; the ratio of F4/80 cells increased in the Honghua and Gegensu groups; the expression of MHCⅡ molecule on the CD4+ T cell surface increased in 10 kinds of TCMI groups except the Shuxuening and Yuxingcao groups; the expression of CD40 molecule on the CD11c+ cell surface increased in the Yadanzi, Aidi and Gegensu groups; the expression of CD80 molecule on the CD11c+ cell surface increased in the Xingnaojing group; the expression of CD86 molecule on the CD11c+ cell surface increased and the expression of CD40 molecule on the F4/80 cell surface decreased in the Xiangdan and Honghua groups. Compared with the control group, the expression of CD44 molecule on the CD4+ T cell surface increased in the Xiangdan and Xiyanping groups and decreased in the Huangqi group; the expression of CD44 molecule on the CD8+ T cell surface increased in the Yadanzi, Aidi, Xiangdan, Honghua, Xiyanping and Xingnaojing groups. ConclusionDifferent kinds of TCMI can cause various changes of immune cell surface molecules; a comprehensive investigation of these molecules can provide scientific basis and reference for allergy evaluation of TCMI.

  • 病例报告
    . 2007, 9(2): 131-132.
    A 53-year-old woman with chronic viral hepatitis B was administered with peginterferon α-2a 135 μg/week subcuta-neously for 18 doses. After a 18 d discontinuation of the drug, she occurred cough and dyspnea. Myodynamia of both upper limbs was grade Ⅳ and both lower limbs was grade Ⅲ, A chest x-ray showed interstitial inflammation in the lungs. Laboratory tests revealed CK-MB 329 U/L and CK 4 099 U/L. The levels of CK-MB and CK in the patient were decreased to 13 U/L and 40 U/L respectively, after antiviral therapy, symptomatic therapy and pulse methylprednisolon therapy .
  • 病例报告
    . 2007, 9(2): 111-111.
  • 病例报告
    Yuan Xiangpinga;Cheng Zhentianb;Pan Yuxingb;Liu Zhijun
    . 2010, 12(2): 133-2.
    A 83yearold man with pneumonia received an IV infusion of moxifloxacin 0.4 g in 0.9% sodium chloride once daily and aerosol inhalation of ipratropium bromide and salbutamol. On day 2, biochemical tests showed an ALT level of 201 U/L, an AST level of 455 U/L, and a TBil level of 60 μmol/L. Meanwhile he experienced yellowish skin and sclera. Subsequently, his jaundice progressively worsened and laboratory examinations revealed the following values: TBil 126 μmol/L, DBil 98.6 μmol/L, CCr 187.5 μmol/L, BUN 40.16 mmol/L, 24hour urine protein 0.8 g. Moxifloxacin was withdrawn and changed to concomitant use of cefatriaxone and azithromycin. Twentythree days later, the patient’s biochemical tests basically returned to normal.
  • 中药不良反应
    Yang Yia;Sun Shuboa;Lei Lilia;Nie Leib
    . 2010, 12(2): 147-1.

    A boy aged one and a half years with constipation was given one tablet of Niuhuangjiedu by his parents themselves. One hour later, the child developed facial edema. Subsequently, he experienced convulsion, facial and peripheral cyanosis, respiratory and cardiac arrest, and he was then hospitalized. Physical examination showed a coma state, a sluggish light reflex, a respiratory rate of 60~80 breaths/min, and a blood pressure of 35/0 mm Hg. Laboratory tests revealed the following values: ALT 368.00 U/L, AST 2 000.00 U/L, CK 2 000.00 U/L, LDH 9 040 U/L, Urea 15.20 mmol/L, SCr 114.30 μmol/L. Resuscitations were given immediately and he died from respiratory and cardiac arrest.

  • 安全用药
    . 2005, 7(3): 185-188.
    马来酸罗格列酮属于噻唑烷二酮类口服抗糖尿病药物,可有效降低血糖,改善血管内皮细胞功能。根据近年来的临床应用,发现其可引起面部和下肢水肿、贫血、肝损害及心力衰竭等不良反应,应引起临床重视。
  • 病例报告
    . 2005, 7(3): 214-214.
  • 中毒救治
    . 2003, 5(1): 29-30.
    垂体后叶素是目前治疗大咯血最有效的止血药,但使用时静脉注射过快或用药剂量过大可发生多种不良反应,严重者导致药物中毒性脑病。因此,临床医生应合理使用垂体后叶素,对其不良反应,尤其是中毒反应要给予高度重视。
  • 病例报告
    . 2003, 5(1): 53-53.
  • 安全用药
    . 2003, 5(3): 171-173.
    拉米夫定治疗成人慢性乙型肝炎患者的疗效和安全性已得到肯定,但其对儿童患者的应用报道尚少。本文介绍了近年来国外学者对拉米夫定治疗慢性乙型肝炎儿童患者疗效与安全性的研究进展,供临床参考。
  • 安全用药
    . 2006, 8(5): 350-355.
    抗血小板聚集、抗凝和溶栓等药物广泛应用于冠心病和脑血管病防治。药物对血细胞影响的报道也日渐增多。本文主要介绍抑制血小板花生四烯酸代谢药物、二磷酸腺苷(ADP)受体拮抗剂、血小板糖蛋白IIb/IIIa(GPIIb/IIIa)受体拮抗剂、抗凝和溶栓药物对白细胞、血小板和血红蛋白等血液成分的影响及防治措施,以提高人们对这类药物安全性的认识。
  • 病例报告
    . 2004, 6(2): 116-117.
  • 中药不良反应
    . 2006, 8(5): 390-390.
  • Chen Zhongming
    Adverse Drug Reactions Journal. 2009, 11(3): 212-2.

    A 41-year-old male patient was hospitalized with peptic ulcer bleeding. After admission, the patient was treated with an IV infusion of pantoprazole 40 mg twice daily, an IV infusion of pazufloxacin 0.3 g once daily, etamsylate, aminomethylbenzoic acid, and hydroxyethyl starch. On day 3 of therapy, his WBC count decreased from 11.8×109/L to 1.7×109/L. Leukopenia was considered to be possibly pazufloxacinassociated. Pazufloxacin was stopped and switched to ceftezole, and pantoprazole was continued. His WBC count was 2.7×109/L two days later and 4.1×109/L one week later.

  • 临床论著
    Zhang Jing;Liu Mei;Lin Wei;Li Xiaoqing
    . 2009, 11(2): 87-4.
    Objective: To observe the adverse reactions caused by different doses of Nacetylcysteine (NAC) in treatment of patients with severe liver diseases for an approach to the drug safe use. Methods: Between February 2006 and January 2008, 173 patients with various patterns of severe liver diseases in our hospital were enrolled in the study. One hundred and seventythree patients were divided into 3 groups: the highdose group (25 cases), the lowdose group (66 cases), and the doseescalation group (82 cases). The highdose group comprised 16 men and 9 women with average age (42.3±3.6) years. The lowdose group comprised 42 men and 24 women with average age (41.6±4.8) years. The doseescalation group comprised 51 men and 31 women with average age (45.2±5.2) years. The drug administration was as follows: the patients in the highdose group were administered an IV infusion of NAC 8 g dissolved in 10% glucose 250 ml once daily; the patients in the lowdose group were administered NAC 4 g dissolved in 10% glucose 250 ml once daily, while oral famotidine 20 mg twice daily and slowly IV push of 10% calcium gluconate 10 ml mixed with 50% glucose 20 ml were given. The patients in the doseescalation group received an initial dose of IV NAC 4 g/d, and if no adverse reaction occurred, the dose of NAC was increased to 8 g/d on day 4. The administration and other medications were the same as those in the lowdose group. All patients were observed at least two weeks. Results: In the highdose group, adverse reactions occurred in 16 cases (64%) of 25 patients including 9 cases (36%) of skin disorders, 2 cases (8%) of chest distress and dizziness, 3 cases (12%) of gastrointestinal disorders, one case (4%) of anaphylactic shock, and one case (4%) of lower limbs dyskinesia. The Model for EndStage Liver Disease (MELD) scores to the patients experiencing adverse reactions and the patients no experiencing adverse reactions in the highdose group were 11.26±5.47 and 18.38±5.71, respectively. The difference was statistically significant (P<0.05). It indicated that the condition of patients experiencing adverse reactions was mild. In the lowdose group, adverse reactions occurred in 2 cases (3.03%) of 66 patients including 1 case of rash, and 1 case of upper abdominal discomfort. The incidence of adverse reactions in the lowdose group was lower than that in the highdose group. The difference was statistically significant (P<0.001). The MELD scores in the patients experiencing rash and the patients experiencing upper abdominal discomfort were 11.38 and 10.29, respectively. In the doseescalation group, 4 patients(4.88%) developed adverse reactions within 3 days of treatment; seven(8.97%) of other 78 patients developed adverse reactions in more than 4 days of treatment, and the incidence was higher than the lowdose group and lower than the highdose group (all P<0.001). Of the 78 patients, 31 patients’MELD score was >15, and one case of gastrointestinal disorders and one case of skin rash occurred; 47 patients’MELD score was <15, and 3 case of gastrointestinal disorder, one case of scalp swelling and one case of skin rash occurred. The difference between both of them was statistically significant (P< 0.001). The patients’adverse reactions disappeared after discontinuation of the drug and symptomatic treatment. Conclusion: Lowdose or doseescalation NAC combined with oral famotidine and IV calcium gluconate 10% is a safe regimen in treatment of severe liver diseases, but relatively mild cases of severe liver diseases should be closely monitored during treatment in order to avoid or decrease adverse reaction occurring.
  • 病例报告
    Yang Yia;Lei Lilia;Qin Wenbob
    . 2008, 10(3): 210-2.

    Three men, aged 38, 46, and 41 years, were infused with alginic sodium diester 100 mg once daily intravenously. Two to four days later, they developed penile erection lasting for 24~72 hours. The patients were treated with ice packs and compression to the penis, aspiration of the excess blood from the penis, irrigation of the penis using heparinised saline solution, intracavernous injection of dopamine, and oral administration of diazepam. Later, their symptoms resolved completely.

  • 病例报告
    . 2000, 2(1): 53-53.
  • Cao Shufang; Huang Dongwei;Tan Ruixing;Zhang Deming
    Adverse Drug Reactions Journal. 2009, 11(6): 439-3.
    A 78yearold man with idiopathic pulmonary interstitial fibrosis received combination therapy with prednisone, azathioprine, and tripterygium glycosides. Azathioprine 150 mg/d was given for 19 months and the total dose was 93 g. Two year later, the patient developed fever and dyspnea. On admission, routine blood test revealed following values: WBC count 0.83×109/L, N 006, L 0.86, M 0.18~0.39, PLT count 74×109/L, Hb 121 g/L. Bone marrow smear showed marked hyperplasia of nucleated cells with 50% unclassifiable cells which was dark grey and mediumlarge with pseudopods and small redpruple particales filling with the cytoplasm without Auer body. Bone marrow biopsy showed hypoplasia and decreases in three cell lineages. Staining of blood cells was negative or weakly positive for peroxidase and 90% positive rate of alkaline phosphatase. On day 76 of admission, bone marrow picture revealed marked hyperplasia of nucleated cells with 56% immature mononuclear and inhibition of three cell lineages on reexamination. A SC cytarabine 200 mg/d was given for 2 days, but this had no obvious effect. On day 128 of admission, he died.
  • 病例报告
    Pan Xiaoping;Cai Guangxian;Liu Baiyan;Zeng Bairong;Zhang Hong
    . 2009, 11(4): 276-2.
    A 65yearold man who relapse 2 years and more after surgery of pulmonary carcinoma received oral erlotinib 150 mg once daily. The patient had no previous history of cardiovascular diseases, and his ECG was normal before erlotinib therapy. On day 5 of therapy, he developed chest distress, dizziness, short of breath, and transient syncope. After erlotinib discontinuation and receiving symptomatic treatment, his symptoms gradually relieved and his heart rate normalized. Subsequently, erlotinib was readministered and the patient developed transient syncope again, his heart rate ranged from 45 to 54 beats/min (minimum heart rate<32 beats/min) and he also had frequent atrial and ventricular premature beats, atrial flutter, atrial fibrillation, sinus pause, and tachycardiabradycardia syndrome, so the patient underwent permanent pacemaker implantation.
  • 病例报告
    Li Jingdonga;Zhao Shuguoa;Chang Xiaoyueb
    . 2009, 11(4): 287-2.
    A 35yearold woman with acute pulvic inflammation received an IV infusion of metronidazole 0.5 g, followed by an IV infusion of fibrauretin 80 mg in 500 ml of glucose 5%. The patient developed tongue numbness, salivary gland swelling, and a fever of 38.2℃ while receiving about 200 ml of fibrauretin infusion. Fibrauretin was stopped immediately. An IV infusion of dexamethasone 10 mg and IM diphenhydramine 20 mg were given. Thirty minutes later, his symptoms gradually relieved. The next day, salivary gland swelling disappeared basically. Subsequently, the patient received cefotaxime and metronidazole, and the abovementioned symptoms did not recur.
  • 调查研究
    Gao Wenbin;Yin Liangwei;Qi Xiaojun;Wang Huaijin
    . 2003, 5(1): 5-8.
    Objective; To observe ramosetron's effects on prevention of gastrointestinal reactions induced by cisplatin and doxorubicin. Method: 156 cancer patients with an indication of intra-arterial chemotherapy were randomly divided into two groups, 78 cases each receiving cisplatin (≥50mg/m2) and doxorubicin (≥40 mg/m2) respectively in the therapy scheme. 15-30 minutes before chemotherapy group one was given with ramosetron 0.3mg and group two granisetron 3mg (plus dexam-ethasone10mg) by intravenous injection. The patients were monitored during the first three days for effects and unwanted reactions of the two drugs. Results; Compared with granisetron, ramosetron showed the same therapeutic effects on anorexia, nausea and vomiting. And no significant differences of adverse reactions were found in the two groups, such as headache, carebaria, thirst, constipation, diarrhea, hot flushes, fatigue, drowsiness, insommia and dysphoria. Conclusion; As a new generation of 5-HT3-receptor antagonist, ramosetron has proved to be safely used for its antiemetic properties in clinical practice.
  • 病例报告
    . 2006, 8(5): 378-378.
  • 病例报告
    . 2006, 8(3): 214-215.
  • 综合报道
    . 2000, 2(4): 245-247.
  • 专题讲座
    . 2006, 8(1): 45-49.
  • 调查研究
    Wu Jiarui;Zhang Bing
    . 2006, 8(1): 24-27.
    Objective: To investigate the clinical characteristics and causative factors of Chuanhuning injection-induced thrombocytopenia. Methods: 62 cases of Chuanhuning injection-induced thrombocytocytopenia were collected by a search of domestic medical journals published between January 1994 and December 2004, and analysed by literature metrology. Results: Of the patients 33 were male, and 29 were female 53.4% of them were younger than 18 years old. Routine dosages of Chuanhuning injection were administered by intravenous infusion in all cases, and 44.2% developed thrombocytopenia within 2-6 hours after administration. Conclusion: It is important to understand Chuanhuning injection-caused thrombocytopenia, so as to be safe use of the drug.
  • 病例报告
    . 2003, 5(6): 407-407.
  • 病例报告
    . 2002, 4(2): 122-122.
  • 专题讲座
    . 2002, 4(4): 245-251.
  • Sun Yunchuana;Jiang Jialib
    Adverse Drug Reactions Journal. 2009, 11(6): 433-2.
    A 74yearold man with coronary heart disease received atorvastatin calcium 20 mg once daily, isosorbide mononitrate 20 mg twice daily, metoprolol 25 mg twice daily, fosinopril sodium 10 mg once daily, and entericcoated aspirin 0.1 g once daily. After about 3 months of therapy, the patient developed yellowish skin and sclera, skin itching, claylike stool, and dark urine. Laboratory tests revealed the following levels and values: ALT 85 U/L, AST 80 U/L, TBil 246.8 μmol/L, DBil 138 μmol/L, total bile acid 95.5 μmol/L, ALP 221 U/L, γGT 240 U/L, urine bilirubin 50 μmol/L. Atorvastatin calcium was discontinued and other medications were continued. Meanwhile liverprotective treatment was given and his symptoms improved. Fiftyone days later, his liver function normalized.
  • Zhang Aiwu;Wang Yi
    Adverse Drug Reactions Journal. 2009, 11(5): 375-2.
    A 22yearold woman received 5 Narusanwei pills for gingival swelling and pain. Thrity minutes later, the patient developed chest pain, dizziness, and nausea. He was hospitalied with aggravated symptoms accompanied by vomiting, pale, and peripheral cyanosis of limbs after 6 hours. He was treated with oxygen inhalation and underwent ECG monitoring immediately. An examination revealed a BP of 80/50 mm Hg, apathy,and confusion. ECG showed frequent ventricular extrasystole with bigeminy and ventricular fibrillation. The myocardial enzyme tests revealed the following levels: AST 151.1U/L, LDH 532U/L, CK 1113U/L, CK-MB 135.5U/L, α-HBDH 427U/L, and troponin T 1.60 μg/L.He was diagnosed with frequent ventricular premature beats, ventricular fibrillation, druginduced cardiac damage, and cardiac shock. A potassium supplement, an IV infusion of dopamine, and symptomatic therapy were given. Her condition improved. And he recovered after 15days of further treatment. The patient had no recurreace of any symptoms at 2-month follow-up .
  • 病例报告
    Zhang Xiuhong;Lu Yi
    . 2010, 12(2): 113-2.
    A 55year old woman received initially one tablet of paracetamol, pseudoephedrine hydrocholoride and dextromethorphan hydrobromide Tablets Ⅱ (day use tablets), and subsequently one tablet of paracetamol, pseudoephedrine hydrochloride, diphenhydramine hydrochloride and dextromethorphan hydrobromide tablets (night use tablets). Two weeks later, the patient developed facial erythema which gradually increased and progressed to involve her trunk and extremities. Meanwhile she experienced oral mucosa erosion, conjunctiva hyperemia, erosion in palpebral margin, numerous vesicles on toes, as well as erythema in labium majus. Her temperature was 39.2℃. Routine urine tests revealed the following values: WBC 182.2 cells/μL, RBC 89.6 cells/μL, ketone(+), leukocyte esterase(++), glucose(++++), occult blood(+++). She was given antiallergic, preventing infective, symptomatic, and supportive treatments. Four days later, her condition improved and the erythema disappeared after 13 days.
  • 病例报告
    . 2000, 2(1): 69-69.
  • 病例报告
    Li Hui;Wang Meikang;Wang Ying;Gao Wa
    . 2010, 12(6): 428-2.
    A 71yearold man received an IV infusion of dicycloplatin 650 mg in 5% glucose 1000 mL for chemotherapy after undergoing excision of right lung cancer. The infusion was completed within 4 hours. The next day, the patient developed weakness in lower limbs and nausea. Three weeks later, he received his second chemotherapy course and the regimen was the same as the first chemotherapy. The next day, he developed nausea and right nasal cavity bleeding. Laboratory tests revealed the following levels: WBC count 3.04×109/L, N 0.50, L 0.37, Hb 83 g/L, RBC count 2.76×1012/L, PLT count 35×109/L. Local nasal cavity hemostasis and other symptomatic treatments were given immediately. Three days later, nasal cavity bleeding ceased and his routine blood tests normalized. Laboratory tests showed the following levels: WBC count 4.04×109/L, N 0.53, L 0.35, Hb 86 g/L, RBC count 4.16×1012/L, PLT count 87×109/L.
  • 病例报告
    PENG Hui;QI Xiao-lian
    . 2012, 14(5): 302-3.
    A 3-year-old girl with epilepsy received valproate sodium 180 mg once per 12 hours, but due to poor response, ketogenic diet therapy was added to her regimen. Before giving ketogenic diet therapy, her blood ammonia level was 64 μmol/L. On days 1-3 of ketogenic diet therapy, the ratio of fat and carbohydrate to protein in her diet was gradually increased from 1 ∶ 1 to 3 ∶ 1. On day 4, the ratio was adjusted to 4 ∶ 1 and her blood ammonia level was 63 μmol/L. On day 7 of ketogenic diet therapy, her blood ammonia level rose to 95 μmol/L, and then valproate sodium was changed to 120 mg once per 12 hours orally. On day 10 of ketogenic diet therapy, valproate sodium was decreased to 60 mg once per 12 hours orally and, on day 11, her blood ammonia level was 68 μmol/L. On day 13 of ketogenic diet therapy, she continued to receive valproate sodium at a decreased dosage. During ketogenic diet therapy, her epileptic condition was well controlled.
  • 论著
    Lu Min;Zhou Ying;Liu Xiao;Cui Yimin
    . 2014, 16(1): 27-3.

    ObjectiveTo explore the effects of metformin discontinuation before and after iodine contrast agents use on blood glucose levels in diabetic patients.MethodsAll subjects were diabetic inpatients in Peking University First Hospital from January 1 to December 31, 2012. The inclusion criteria included that the blood glucose levels were basically within safe range, metformin was stopped 48 hours before and after iodine contrast agents use, and the glucose levels were monitored and recorded at five time points (fasting, 2 h after breakfast, 2 h after lunch , 2 h after supper and before bedtime). The patients whose hypoglycemic therapies were adjusted during metformin discontinuation were entered in the adjustment group and the patients whose hypoglycemic therapies were not adjusted during metformin discontinuation were entered in the non-adjustment group. The clinical data of patients in the 2 groups were collected and retrospectively analyzed.ResultsA total of 80 patients in accordance with inclusion criteria were enrolled in this study. Of them, 62 patients (87.5%) were in the non-adjustment group and 18 (22.5%) were in the adjustment group. The metformin was stopped 2-4 days. The blood glucose levels in the patients in the non-adjustment group increased to different degrees at five-point [(7.7±1.4)mmol/L vs.(7.0±1.2)mmol/L, (9.5±1.7)mmol/L vs.(9.0±1.8)mmol/L, (10.9±2.3)mmol/L vs.(8.6±1.9)mmol/L, (9.9±1.7)mmol/L vs.(8.6±1.7)mmol/L, (9.1±1.9)mmol/L vs.(8.5±1.6)mmol/L]after drug discontinuation. Compared with before drug discontinuation, the blood glucose levels at fasting, 2 h after lunch and 2 h after super increased significantly (P=0.01, P=0.00, P=0.00). The differences of the blood glucose levels before and after drug discontinuation in the patiets in the adjustment group were not statistically significant [(7.9±1.2)mmol/L vs.(8.1±1.8)mmol/L, (8.0±2.2)mmol/L vs.(8.5±2.4)mmol/L, (9.2±2.9)mmol/L vs.(10.3±1.9)mmol/L, (9.4±2.1)mmol/L vs.(9.1±2.4)mmol/L, (10.0±2.3)mmol/L vs.(9.3±2.2)mmol/L; P>0.05 for all comparisons].ConclusionsThe blood glucose levels increased significantly in diabetic patients without adjusting hypoglycemic therapy when metformin was stopped before and after iodine contrast agents use. The adjustment for hypoglycemic therapy will benefit the control of blood glucose level.

  • Shu Wenlin;Su Zhijian
    . 2015, 17(1): 63-2.
    An 88-year-old male patient with chronic obstructive pulmonary disease received an IV infusion of piperacillin sodium and tazobactam sodium 4.5 g twice daily for lung infection. His renal function was normal before drug use. On day 2, his serum urea and creatinine were 9.7 mmol/L and 164 μmol/L respectively, and 24 hour urine volume was 100 ml. He was given bladder irrigation but still had anuria. Acute renal insufficiency was considered. On day 3, the patient was treated with continuous renal replacement and piperacillin sodium and tazobactam sodium was stopped. On day 6, the urine volume increased to 2 150 ml. After an interval of 4 days, the patient received piperacillin sodium and tazobactam sodium (the same dosage as before) again for secondary lung infection. On the second day, the patient developed oliguria again and his serum urea and creatinine were 34.9 mmol/L and 382 μmol/L respectively. Piperacillin sodium and tazobactam sodium was withdrawn. Two days later, the urine volume increased obviously. Four days later, his serum urea and creatinine were 12.9 mmol/L and 168 μmol/L respectively.
  • Zhang Hanyu
    . 2015, 17(5): 383.
    A 70-year-old man with pneumonia received an IV infusion of ceftizoxime sodium 3 g in 0.9% sodium chloride 250 ml twice daily. Twenty minutes after the first infusion, he developed low back pain, chills and confusion. He presented with moderately jaundiced skin and sclera. Laboratory tests revealed the following results: white blood cell (WBC) count 11×109/L, neutrophil 0.8, red blood cell (RBC) count 3.2×1012/L, hemoglobin 91 g/L, reticulocytes 0.081, total bilirubin 98 μmol/L, indirect bilirubin 80 μmol/L. Direct Coomb′s test(+). He developed strong tea-colored urine. Routine urine tests showed the following results: urine bilirubin (+), occult blood (+++), 0-2 red cells per high power field. Ceftizoxime sodium-induced acute hemolytic anemia was considered. He received hydration and alkalizing of urine. Ceftizoxime sodium was switched to fosfomycin. On day 5, the jaundice disappeared and the color of urine returned to normal. Laboratory tests showed the following results: WBC count 4×109/L, RBC count 4.2×1012/L, hemoglobin 131 g/L, reticulocytes 0.015, total bilirubin 17 μmol/L, indirect bilirubin 10 μmol/L, urine bilirubin (-), occult blood (-), 0-1 red cells per high power field.
  • An Hong, Wu Liyong, Wang Lin, Jia Jianping
    . 2016, 18(3): 233.
    A 55-year-old male patient self-medicated with 2 fentanyl transdermal patches (8.4 mg/paste) for neck discomfort. After 4 hours, he presented sobbing respiration and disturbance of consciousness. He was comatose without breathing when he was sent to the emergency room. He received electrocardiographic monitoring, tracheal intubation and assisted breathing with ventilator immediately, at the same time, IV injection of nikethamide 0.375 g and lobeline hydrochloride 3 mg were given. Arterial blood gas analysis showed the concentration of hydrogen ions was 6.97, carbon dioxide partial pressure was 97.8 mmHg, oxygen partial pressure was 86.2 mmHg and oxyhemoglobin saturation was 0.90. Six hours later, the patient′s consciousness turned clear. The next day, toxicological tests showed that fentanyl concentration in blood and urine was 70 ng/ml and 92 ng/ml respectively. On the third day, reexamination of arterial blood gas analysis showed that the concentration of hydrogen ions was 7.46, carbondioxide partial pressure was 30.2 mmHg, oxygen partial pressure was 151.0 mmHg and oxyhemoglobin saturation was 1.00, and then the tracheal intubation was removed.
  • Li Jinfeng, Qu Guanghong, Zhang Yuan
    Adverse Drug Reactions Journal. 2020, 22(7): 422-423. https://doi.org/10.3760/cma.j.cn114015-20190201-00113
    A 75-year-old male patient received an IV infusion of salivae miltiorrhizae, liguspyragine hydrochloride and glucose injection 200-ml once daily for cerebral infarction. No other drugs were used in the same period. About 6 hours after the first administration, the patient developed erythema and blister all over the body, accompanied by obvious itching. Next day, the patient had a fever, blisters of different sizes could be seen on a large area of swollen erythema, some of the blisters were broken, the area of skin lesions was more than 50% of the body surface, and Nikolsky′s sign was positive. Epidermolysis bullosa caused by salivae miltiorrhizae, liguspyragine hydrochloride and glucose injection was considered. The drug was stopped and anti-allergy and anti-infection treatments including methylprednisolone, calcium gluconate, loratadine, and cefazolin sodium were given. Meanwhile, skin care was strengthened. Three days later, the patient′s body temperature returned to normal, the color of erythema became lighter, and the blisters became smaller. Fifteen days later, the patient′s skin injury basically healed.
  • Zhang Zhiqi, Gao Jie
    Adverse Drug Reactions Journal. 2022, 24(8): 439-441. https://doi.org/10.3760/cma.j.cn114015-20211222-01291
    A 58-year-old female patient with breast cancer received cyclophosphamide and doxorubicin hydrochloride liposome injection chemotherapy twice after modified radical mastectomy. The patient was pretreated with dexamethasone injection 5-mg before chemotherapy. After each chemotherapy, mucosal ulcer of different degrees occurred, and both hands and feet were red and swollen, which showed an aggravating trend, but were all improved after a few days. After the 3rd chemotherapy, the patient′s hands and feet were red and swollen, accompanied by blisters and exudation, her body temperature rose up to 40.0 ℃, with large area of erythema on his back, axillary erythema with erosion exudation, and oral mucosal ulcer. It was considered that the patient was likely to have hand-foot syndrome. Methylprednisolone, cefoxitin, omeprazole, and other drugs, external skin care measures such as wet compress of the affected area with furacilin solution and keeping the skin moist were given. After 15 days of treatments, the patient′s hands and feet symptoms were improved. Then doxorubicin hydrochloride liposomes injection were stopped and replaced by docetaxel, and hand and foot symptoms in the patient did not recur.
  • Wu Yupei, Yin Yuesong, Wang Qian, Wang Dongmiao, Zhang Lina
    Adverse Drug Reactions Journal. 2022, 24(9): 494-496. https://doi.org/10.3760/cma.j.cn114015-20220720-00655
    A 66-year-old female patient with infiltrating adenocarcinoma in left lung received anlotinib 12-mg orally once daily (2-week medication followed by 1-week discontinuation, 3 weeks was a cycle). After 14 months of regular medication, the patient developed palpitation and chest tightness. Laboratory tests showed that the N-Terminal pro-brain natriuretic peptid (NT-proBNP) was 1-698-ng/L; echocardiography showed decreased apical wall motion and left ventricular diastolic dysfunction. Heart failure was condsidered, which was suspected to be related to anlotinib. Anlotinib was stopped and symptomatic treatments were given. Eight days later, her symptoms above-mentioned were alleviated and NT-proBNP was 485-ng/L. Because of the illness condition, the patient took anlotinib again at original dose according to the doctor′s instructions. Three months later, the above symptoms recurred and ventricular fibrillation occurred suddenly. Considering that the heart failure in the patient might be caused by anlotinib. Anlotinib was stopped again. After 11 days of treatments with diuretics, cardiac function improvement, myocardial nutrition, and potassium supplement, the patient′s condition was improved obviously. After that, the patient did not take anlotinib again.
  • Zhu Wenting, Bai Qiujiang, Nie Li
    Adverse Drug Reactions Journal. 2024, 26(12): 762-764. https://doi.org/10.3760/cma.j.cn114015-20240130-00073
    A 78-year-old female patient with type 2 diabetes for 30 years, hypertension for more than 10 years, diabetes nephropathy for 4 years, and renal anemia for several years additionally received roxadustat (70 mg thrice per week orally) for anemia. After 5 days, the patient developed sudden chest tightness, asthma, acute left heart failure, and depressed edema of both lower limbs. The electrocardiogram showed sinus arrest, escape rhythm, and a heart rate of 40 beats per minute. Laboratory test results showed   blood  pH 7.31, blood potassium 5.3 mmol/L, blood creatinine 304 μmol/L, B-type natriuretic peptide 1 280.0 ng/L, high sensitivity troponin T 0.042 μg/L, and creatine kinase MB 0.83 μg/L. Acute left heart failure, hyperkalemia, and metabolic acidosis caused by roxadustat were considered. Roxadustat and other long-term oral medication such as hypoglycemic and antihypertensive drugs were discontinued. Symptomatic treatments such as sodium bicarbonate, insulin, furosemide, calcium gluconate, and blood filtration were given. Two days later,the patient′s heart rate and blood potassium returned to normal; 7 days later, the patient′s B-type natriuretic peptide was 168.0 ng/L, blood creatinine was 170 μmol/L, and blood potassium was 4.13 mmol/L. The patient had no chest tightness or asthma, and no edema in both lower limbs. Long-term oral medication such as hypoglycemic and antihypertensive drugs were given again. At a 1 month follow-up, the patient did not experience chest tightness or asthma, and the electrolyte levels were normal.
  • Yin Yue, Zhang Yanhua
    Adverse Drug Reactions Journal. 2024, 26(9): 513-518. https://doi.org/10.3760/cma.j.cn114015‑20240628‑00495
    Drugs or their metabolites may accumulate in the body due to the decline of renal excretion function in cancer patients with renal insufficiency. Therefore, adjusting the treatment scheme and drug dose according to the patient′s renal function is an important part of anticancer treatment for these patients. The Japanese Society of Nephrology, Japan Society of Clinical Oncology, Japanese Society of Medical Oncology, and Japanese Society of Nephrology and Pharmacotherapy have jointly formulated Clinical Practice Guidelines for Management of Kidney Injury During Anticancer Drug Therapy 2022, and specifically discusses the dose adjustment of anticancer drug treatment for patients with renal injury in the second chapter.
    This article focuses on the interpretation of the application and dose adjustment of antifolate agents, BCRABL1 tyrosine kinase inhibitors, epithelial growth factor receptor tyrosine kinase inhibitors, antibody molecularly targeted agents and tumor adjuvant therapy drugs such as bone‑modifying agents in patients with renal injury in this chapter. 
  • Zhang Lina, Wang Quan, Li Jinfeng, Fang Wei
    Adverse Drug Reactions Journal. 2023, 25(9): 572-574. https://doi.org/10.3760/cma.j.cn114015-20220615-00527
    A 66-year-old male patient with chronic bronchitis for more than 50 years received 0.1 g of aminophylline once or twice daily orally. Because of cough and runny nose, he took 1 compound parace- tamol and amantadine hydrochloride tablet twice daily orally and added the dose of aminophylline to 0.2 g twice daily by himself. After 3 days of medication, the patient experienced sudden unconsciousness and limb convulsions without any triggering factors, with a total of 6 episodes. The results of brain magnetic resonance imaging and electroencephalography were normal. The possibility of intracranial infection could be ruled out through cerebrospinal fluid examination. Laboratory test showed creatine kinase (CK) 1-574-U/L. After 4 days of experimental treatments with haloperidol, piperacillin sodium, tazobactam sodium, budesonide suspen- sion, etc., his CK was 217-U/L and no further seizures occurred. The patient′s seizures were considered to be related to combination of compound paracetamol and amantadine hydrochloride, and aminophylline.
  • ia Shuhong, Cui Lei, Dong Mingrui, Duan Xiaohui, Wang Renbin, Jiao Jinsong, Peng Dantao
    . 2016, 18(6): 453.
    A 60-year-old male patient took metronidazole 0.6-1.0g daily by himself for one month because of his toothache  and the feeling of insect creeping at anus. He developed numbness on toes after stopping  metronidazole gradually. About 10 days later, he received an IV infusion of ornidazole 0.5 g, cefuroxime sodium 2.25 g, and vinpocetine 20 mg daily for 10 days because of dizziness and vomiting.The numbness extended to his haunch 5 days after IV infusion of ornidazole. Two months after stopping ornidazole, his numbness descended to knee. The results of electromyogram 10 months after appearance of numbness showed that the axial cord injury of sensory nerves in both lower limbs  and right upper limb, the degree of injury in lower limbs was more severe than that in the upper limb. Sural nerve biopsy revealed that myelinated fiber density was reduced severely, thin myelinated fibers increased. There were swollen axons and myelobulbar structure, and nerve regenerative clusters. The results of sural nerve biopsy suggested axonal lesion. The results of accessory examinations eliminated the metabolism, immunity, and inflammation related peripheral neuropathy. The patient was diagnosed as peripheral sensory neuropathy due to metronidazole. He received nutritional therapy. The feeling himself to numbness showed that his symptoms was slightly improved at follow up one year later.
  • Zhang Yan, Su Yingying, Ye Hong, Gao Daiquan
    . 2015, 17(5): 321.
    ObjectiveTo evaluate the efficacy and safety of intravenous immunoglobulin (IVIG) for treatment of anti-N-methyl-D-aspartate (NMDA) receptor encephalitis.MethodsData of patients with anti-NMDA receptor encephalitis seen in Xuanwu Hospital, Capital Medical University from January 2012 to December 2014 were collected and a retrospective study was conducted. All patients received the first course of treatment with IVIG 0.4 g/(kg·d), once daily for 5 consecutive days. The adverse reactions of IVIG during the observational period of IVIG administration and one week thereafter were recorded. The therapeutic effect of IVIG was assessed by using modified Rankin Scale one month post IVIG. According to the therapeutic effect of IVIG, patients were divided into effective group and ineffective group.ResultsTwenty-six patients were enrolled, including 11 male and 15 female with an average age of (25±10) years (16 to 57 years). The duration from symptom onset to starting treatment of IVIG was 8-68 days (median 26 days). Treatment effects were assessed after one month post IVIG. Fourteen patients (53.8%) had improvement (effective group, including 6 patients who were improved significantly and 8 patients improved). The mean duration between the treatment of IVIG and clinical improvements was 17 (range 7-30) days. Percentage of male in the effective group was higher than that in the ineffective group [64.3% (9/14) vs.16.7% (2/12), P<0.05]. The efficacy rate in males patients was higher than that in female patients[81.8% (9/11) vs. 33.3% (5/15), P<0.05]. During the observational period, 3 patients had fever, 2 patients had abnormality of liver function, and 1 patient had rash. The symptoms and abnormality of laboratory tests disappeared after reducing the speed of IVIG infusion, liver-protective and antianaphylactic treatment. ConclusionThe treatment with IVIG for anti-NMDA receptor encephalitis was effective and relatively safe, therefore IVIG could be used as the first-line immunotherapy.
  • Wang Jian, Bao Feng, Pan Weigang,
    . 2015, 17(2): 112-116.
    To analyze the risk of hyponatremia induced by antidepressant drugs and related risk factors.MethodsMedical record data of patients who were treated with antidepressant drugs during hospitalization in Beijing Anding Hospital, Capital Medical University from January 2009 to December 2010 were collected and a retrospective controlled study was conducted. The blood sodium level <135 mmol/L was defined as hyponatremia (the levels of 131-<135, 120-130, and <120 mmol/L were defined as mild, moderate and severe hyponatremia, respectively). The patients whose serum sodium levels were <135 mmol/L at lease one time during hospitalization were enrolled into the hyponatremia group. The detection day when the serum sodium level was <135 mmol/L for the first time was defined as calibration date. The patients whose serum sodium levels were from 135 to 144 mmol/L were enrolled into the control group. They were selected randomly before or after 5 days of calibration date. The demographic characteristics, psychiatric diseases, combined somatic diseases, related laboratory examinations, antidepressant drugs, and other concomitant drugs in patients in the 2 groups were compared. The risk factors related to hyponatremia were evaluated using Logistic regression analysis and the odds ratios (OR) with 95% confidence intervals (95% CI) were calculated.ResultsA total of 214 patients were enrolled into the study. Of them, 58 patients were in the hyponatremia group and 156 were in the control group. The numbers of patients with mild, moderate, and severe hyponatremia were 38 (65.5%), 8 (13.8%), and 12 (20.7%), respectively, among the 56 patients in the hyponatremia group. The percentages of patients ≥ 65 years old, with alcohol or drug dependence, selective serotonin reuptake inhibitors (SSRI) treatment in the hyponatremia group were higher than those in the control group [65.5% (38/58) vs. 37.8% (59/156), 24.1% (14/58)  vs. 3.6% (6/156), 69.0% (40/58) vs. 38.5% (60/156), all P<0.001]. The percentages of patients with lung disease, combined use of diuretics, anti-epileptics or β-adrenoceptor blockers in the  hyponatremia patients were higher than those in the control group. The results of the Logistic regression analysis showed that SSRI treatment, age ≥65 years, alcohol or drug dependence,  combined use of diuretics, anti-epileptics or β-adrenoceptor blockers were risk factors related to hyponatremia [SSRI treatment:χ2 =8.336, OR=3.023, 95%CI: 1.02-9.67, P=0.001; age ≥65 years:χ2=6.482, OR=2.911, 95%CI: 1.36-9.06, P=0.032; alcohol or drug dependence:χ2 =5.632, OR=2.428, 95%CI: 1.20-4.94, P=0.021;combined use of anti-epileptics:χ2 =6.717,OR=2.217, 95%CI: 1.21-4.03, P=0.010; combined use of diuretics:χ2 =5.893, OR=1.920, 95%CI: 1.07-3.44, P=0.028; combined use of β-adrenoceptor blockers:χ2 =3.853, OR=1.643, 95%CI: 1.00-2.69, P=0.049].ConclusionsAntidepressive agents treatment, especially SSRI is a high-risk factor of hyponatremia. Age ≥ 65 years, alcohol or drug dependence, combined use of diuretics, anti-epileptics or β-adrenoceptor blockers are risk factors of hyponatremia in patients taking antidepressive agents.
  • 论著
    LIU Xia;XIANG Zheng;XIAO Hang;ZHANG Jian-feng;LI De-wei;DOU De-qiang
    . 2012, 14(5): 285-4.
    ObjectiveTo explore the effects of half hemolytic degree (HD50) detection on alerting hemolytic reactions caused by saponin-containing traditional Chinese medicine compound injection. Methods The red cell suspension (volume fraction 11%) was prepared with blood taken from the ear edge vein of rabbits and physiological saline solution. The red cell suspension was added into the saponin-containing traditional Chinese medicine compound injection (Shenmai injection or Shengmai injection) with different batch numbers and different concentrations produced by different pharmaceutical factories. The HD50 was detected using spectrophotometry, the concentration-hemolytic degree curve was performed by Sigmaplot 10.0 software and HD50 was calculated. The contents of total phenols and tannins in the two kinds of above-mentioned injections were measured according to the method in Chinese Pharmacopoeia. The correlation between contents of total phenols, tannins and HD50 was analyzed using SPSS 19.0 software. ResultsThe differences in HD50 were significant among six batches of Shenmai injection produced by Hebei Shenwei pharmaceutical factory. Among them, two batches of injection failed to reach the half hemolysis at the highest concentration, and the HD50 of other four batches of injection (0116, 0.147, 0.182 and 0.236 ml/ml ) were lower than those of two batches of injection (0.333, 0.363 ml/ml) produced by Sichuan Shenghe pharmaceutical factory. The Shenmai injections with lower HD50 had higher content of tannins. The hemolytic activity, the contents of total phenols and tannins in Shengmai injection produced by Shanxi Taihang pharmaceutical factory were higher than those in Shengmai injection produced by Sichuan Yibin pharmaceutical factory(the former were 0.066 ml/ml, 1.298 mg/ml and 0.361 mg/ml, the latter were 0.079 ml/ml, 0.221 mg/ml, and 0.029 mg/ml, respectively). HD50 and content of total phenols in Shenmai injection showed a significant negative correlation (r=-0.936, P=0.009). ConclusionHD50 detection could reflect the hemolytic activity of saponin-containing traditional Chinese medicine compound injection and might use in alerting the hemolysis caused by the drugs.
  • 论著
    GUO Xiang;ZHANG Hong-shun;LONG Xin;SUN Cheng-ye
    . 2012, 14(2): 82-6.
    ObjectiveTo study the pathological changes of paraquat-induced ocular injury process in rabbits in order to lay the basis for creating an animal model of paraquat-induced ocular injury. Methods Using a random number table, 20 healthy conventional New Zealand white rabbits were divided into 5 groups, each group comprised 4 rabbits. paraquat stock solution 100 μl was dropped into left conjunctival sac of each rabbit and then its eyelids were closed. paraquat stock solution was kept in conjunctival sar for 30 seconds ( the 30 seconds group), 1 hour ( the 1 hour group), 4 hours ( the 4 hours group), 8 hours ( the 8 hours group), and 24 hours ( the 24 hours group), respectively. The normal saline solution 100 μl was dropped into the right conjunctival sac of each rabbit served as controls. After exposure to paraquat stock solution, both eyes were washed with normal saline solution for 5 minutes. Conjunctival, iridal, and corneal injuries were observed under slit lamp and corneal fluorescent staining and scores were recorded. The highest accumulated score of ocular injury and complete recovery time were recorded. The animals were sacrificed on day 21 of experiment and the corneas were detached for histopathological observation. Results In the 30 seconds group, mild to moderate conjunctival irritation occurred and iridal and corneal injuries were not observed; the highest accumulated score of ocular injury reached a peak of (14.0±2.3) on day 2 of experiment; the complete recovery time was (9.5±0.6) days; corneal tissue slice revealed no marked pathologic changes. In the 1 hour group, moderate to severe conjunctival irritation appeared, iris did not develop injury and cornea presented with local injure; (5.5±1.9) days after exposure to paraquat stock solution, the highest accumulated score of ocular injury reached a peak of (475±8.5) which was higher than that in the 30 seconds group (P<0.05); the complete recovery time was (13.5±2.4) days; tissue slice showed epithelium flat cell layer losing at corneal injury site. In the 4 hours, 8 hours, and 24 hours groups, the rabbits developed corneal and iris injury which gradually aggravated with the prolonged exposure to paraquat stock solution besides severe conjunctival irritation; on days (6.2±1.0), (7.7±1.0), and (7.2±2.1) of experiment, the highest accumulated score of ocular injury reached the peak of (67.5±10.5), (79.5±9.7), and (80.0±9.5), respectively, which were all higher than the scores in the 30 seconds and 1 hour groups (all P<0.05). There was no statistically significant difference among the 4 hours, 8 hours, and 24 hours groups (P>0.05). Two rabbits in the 4 hours group recovered completely on days 12 and 19 of experiment, respectively, while the other 2 rabbits and all rabbits in the 8 hours and 24 hours groups did not recover completely until 21 days of experiment. Histopathological observation revealed the following: in the 4 hours group, a part of corneal epithelium cells of rabbits losing and “moth-eaten” changes; in the 8 hours group, corneal epithelium flat cells and prickle cells losing, columnar basal cells existing and a part of them even reaching corneal stroma layer, structural disorder of corneal stroma fiberboard layer, granulation tissue and corneal neovascularization appearing; in the 24 hours group, whole corneal epithelial layer exfoliating and only stroma layer, intraelastic layer, and endothelial cell layer existing. ConclusionExposure to paraquat stock solution for 30 seconds could cause conjunctival injury and exposure to paraquat stock solution for 1 hour could cause corneal injury. Exposure to paraquat stock solution for more than 4 hours could cause ocular injury, which was difficult to recover, such as nubecula and scar healing of corneal injury. Ocular injury following rabbit eye was exposed to paraquat stock solution for ≥ 4 hours might serve as an animal mode of ocular injury to paraquat.
  • 论著
    Wang Mei;Ai Hui;Wang Chunmei;Zu Xiaolin;Wang Chenggang;Zhu Xiaoling
    . 2011, 13(3): 157-4.
    Objective: To evaluate the short-term efficacy and safety of different doses of clopidogrel therapy in patients with left main coronary artery disease undergoing percutaneous coronary intervention (PCI). Methods: The ≤75-year-old patients with left main coronary artery disease (a>75% stenosis in the left main stem) undergoing PCI were hospitalized in Emergency Department of Beijing Anzhen Hospital from January 2006 to January 2010 and served as the subjects. All clinical data from the subjects were collected and retrospective analysis was conducted. Patients were divided into the 75 mg dose group (oral administration of 75 mg/d on days 1-30 after PCI) and the 150 mg dose group (oral administration of 150 mg/d on days 1-30 after PCI) according to the doses of clopidogrel use. Maximal platelet aggregation rate and time was measured and recorded before PCI and 1, 7, 14 and 30 days after PCI, and adverse events were observed during hospitalization. Results: A total of 120 hospitalized patients undergoing PCI were enrolled in this study. Of them, 46 were male and 18 were female with mean age of (52±7) years in the 75 mg dose group and 35 were male and 21 were female with mean age of (50±8) years in the 150 mg dose group. The maximal platelet aggregation rates and time before PCI and 1, 7, 14, 30 days after PCI were 84%±18% and (240±48)s, 81%±14% and(238±44)s, 59%±12% and (210±42)s, 48%±10% and (199±40)s, 43%±10% and (184±30)s in the 75 mg dose group, and 86%±16% and (244±46)s, 77%±16% and (239±46)s, 51%±11% and (180±41)s, 40%±10% and (166±33)s, 38%±9% and (159±35)s in the 150 mg dose group. The results of maximal platelet aggregation rate and time showed a decreasing trend after PCI in both groups and the values of the 2 indexes in the 150 mg dose group were lower than those in the 75 mg dose group (all P<0.01). In a comparison of the two platelet aggregation index values 7, 14 and 30 days after PCI with those before PCI or one day after PCI in both groups respectively, the differences were statistically significant (all P<0.05). A comparison of maximal platelet aggregation rate 14 and 30 days after PCI with those 7 days after PCI in both groups showed that the differences were statistically significant (all P<0.05). In the 150 mg dose group, a comparison of maximal platelet aggregation rate one day after PCI with that before PCI revealed that the difference was statistically significant (P<0.05). There were no cardiovascular events such as severe bleeding, myocardial reinfarction and stroke in patients in both groups. No statistically significant between-group difference was found in the incidence [12 cases (18.7%) in the 75 mg dose group, 13 cases (23.1%) in the 150 mg dose group]of adverse reactions, including mild bleeding, abdominal pain, dyspepsia, constipation, rash , dizziness, and headache (χ2=1.046,P=0.593). Conclusion: The dose of clopidogrel 75 mg/d or 150 mg/d is effective and safe in the treatment of patients with left main coronary artery disease undergoing PCI. However, compared with the dose of 75 mg/d, clopidogrel 150 mg/d could significantly inhibit the platelet aggregation and not increase the risk of bleeding, so it might be more beneficial to reduction of the ocurrence of thrombosis after PCI.
  • 病例报告
    Liu Haiyan;Li Tingting
    . 2011, 13(3): 197-2.
    An 80-year-old male patient received an IV infusion of cefodizime sodium 1.5 g dissolved in 0.9% sodium chloride 250 ml for pulmonary infections. While receiving about 10 ml of the infusion, the patient developed palpitation, chest distress, cold intolerance, generalized pruritus, and high fever. Physical examinations showed a temperature of 39.6 , red lamella appearing on generalized skin, especially on his limbs. The infusion was discontinued immediately and he received symptomatic treatment and supportive therapy. Then palpitation and cold intolerance were subsided and his temperature decreased. However, his skin symptoms did not improve. The next day, some flaccid vesicles appeared on his back and limbs, which later progressed to erosion. Skin symptoms due to cefodizime sodium were considered and the drug was not readministered. He received hydrocortisone, chlorphenamine, and other anti-allergic therapy. Meanwhile, fusidic acid was given for anti-infection. Subsequently, his skin symptoms and pulmonary infections improved gradually.
  • 不良事件
    . 2003, 5(1): 54-54.
  • 不良事件
    . 2005, 7(5): 390-390.
  • 病例报告
    Wu Xiaoxiong;Zhu Shijie
    . 2009, 11(1): 60-2.
    A 53yearold woman received 6 cycles of chemotherapy with paclitaxel and carboplatin after undergoing radical operation of endometrioid adenocarcinoma of right ovary. Each cycle lasted 21 days. On day 1 of each cycle, she was given an IV infusion of paclitaxel 270 mg and an IV infusion of carboplatin 700 mg, respectively, followed by a rest period of 20 days. After the third cycle of chemotherapy, the patient developed feet numbness. During 4~6 cycles, she presented with exacerbated feet numbness, and lower extremities weakness that made standing and walking difficult. Despite administration with vitamin B complex tablets and mecobalamin injection, her symptoms did not disslove. The adverse reactions were considered to be paclitaxel and carboplatininduced. The patient was treated with an IV infusion of timopentin 1 mg once daily, an IV infusion of compound Kushen injection 15ml once daily, oral vitamin B6 60 mg twice daily and a Chinese herbal decoction. Fifteen days later, his symptoms were relieved.
  • 病例报告
    Liu Haiyana;He Meiyanb;Wang Yafengc
    . 2009, 11(1): 52-2.
    A 42yearold woman, who was coinfected with chlamydia and mycoplasma, started receiving minocycline herself with an initial dose of 0.2 g, followed by 0.1 g every 12 hours. After 5 days of treatment, the patient developed lumbago. On day 6, the drug was stopped. Her symptom was relieved. On day 7, minocycline was restarted. On day 10, she experienced fever, severe headache, and gross hematuria. The following day, chest distress, short of breath, and dry cough occurred. Minocycline was discontinued. Routine blood test revealed the following: WBC 10.08×109/L and N 0.73. Urinalysis revealed 78 WBCs per highpower field, erythrocytes (+++), and protein (+++). After admission, a CT scan revealed diffuse infiltration in her right upper lung lobe and bilateral pleural effusion. Mecillinam, ligustrazine and azitromycin were administered intravenously successively. His chest pain and chest distress improved to some extent. Pulmonary allergy vasculitis was diagnosed. Dexamethasone and chlorpheniramine were given. Symptoms further improved. Ten days after hospitalization, a CT scan revealed her foci in both lungs and pleural effusion disappeared. In addition, a renal biopsy revealed IgAnephropathy. She was treated with dexamethasone, aspirin, dipyridamole, benazepril, and ligustrazine. One month later, urinalysis showed that her protein and occult blood were negative.
  • 中毒救治
    Wang Zhe;Qiu Zewu;Peng Xiaobo;Sun Chengwen
    . 2009, 11(4): 260-2.
    Xiaozhiling injection (containing a small amount of chlorabutanol) is mainly used for treatment of hemorrhoid. A 32-years-old woman received local injection of Xiaozhiling for vascular nevus on her right check. The patient had no discomfort after the first injection of Xiaozhiling 10 ml. One week later, after the second injection of Xiaozhiling 15 ml, she developed dizziness, chest distress, nausea, vomiting, and then tachycardia, decreased blood pressure, respiratory distress, and hematemesis. An examination showed a pulse rate of 181 beats/min, a respiration rate of 40 breaths/min, a BP of 56/39 mmHg. Laboratory test revealed the following values: WBC count 15.38×109/L, N 0.924, PLT count 80×109/L, PT 17.7 s, PTA 54.1%, AST 55 U/L, TBil 22μmol/L, DBil 2 μmol/L, GLU 16.8 mmol/L, LDH 683 U/L, ALB 22 g/L, Chest X-ray revealed a flaky nubilous shadow in the lungs. Blood gas analysis showed type Ⅰrespiratory failure. Blood and urine tests revealed a chlorobutamol level of 920 ng/ml and of 854 ng/ml, respectively. After symptomatic treatment, blood and urine chlorobutamol levels decreased to 280 ng/ml and 130 ng/ml, respectively. The results of routine blood test, liver and renal function tests, and a chest CT scan returned to within normal ranges.
  • Zhang Fang;Chen Anjin
    Adverse Drug Reactions Journal. 2009, 11(3): 217-2.

    A 54-year-old male renal transplant recipient received allopurinol, prednisone, and sodium bicarbonate for gout in the past three years. In recent one month, his gout symptoms were exacerbated, then he was hospitalized and celecoxib 0.2 g twice daily was added to his regimen. The patient's renal function was normal and his urine protein was negative before treatment. After three days of therapy, he developed a 1+ urine protein and increased foamy urine. Celecoxib was stopped. After 3 further days, his foamy urine decreased and his urine protein became negative.

  • 国外文献题录
    . 2002, 4(3): 204-206.
  • 病例报告
    Zheng Yi
    . 2010, 12(1): 4-2.
    A 79yearold man with bronchiectasia and pulmonary infections was given an IV infusion of teicoplanin 400 mg/d dissolved in 0.9% sodium chloride 250 ml due to poor control of his disease. On second day, the patient experienced exciting, euphoria, coprolalia, delirium, irritability, accompanied by skin itching. On day 3, his mental symptoms aggravated. Teicoplanin was discontinued and, two days later, the abovementioned symptoms subsided.
  • 综合报道
    . 2001, 3(3): 178-182.
    甲硝唑是用于治疗原虫感染和厌氧菌感染的重要药物之一,随着甲硝唑在临床应用范围的扩展,其不良反应不断增加,一些少见的不良反应也渐有报道。本文将近年来出现的甲硝唑少见的不良反应及一些 严重不良反应综合报道,以引起临床医务人员的重视,将该药导致的不良反应减少至最低。
  • 病例报告
    . 2006, 8(1): 53-54.
  • ADE简报
    . 2000, 2(2): 133-133.
  • 安全用药
    Lou Ying;Li Yishi
    . 2011, 13(1): 32-6.
    Warfarin is a coumarin anticoagulant widely used in the treatment and prevention of thromboembolic disorders. Warfarin has narrow therapeutic window and individual differences in dose, and hemorrhagic complications may occur in clinical use of warfarin. Recent studies indicate that the individual difference in warfarin dose is associated with gene polymorphisms influencing metabolism and action of warfarin such as CYP2C9,VKORC, and so on. The paper reviews the progress of the pharmacogenomics of warfarin in order to provide a reference for rational use of warfarin in clinical practice.
  • 调查研究
    Tong Yuanyuan;Zhang Li;Yang Jinsheng;Yang Xiaohui;Sun Zhenxiao
    . 2010, 12(3): 175-3.
    Objective: To investigate the clinical characteristics and causes of liver damage related to Xiaohe tablets in order to provide reference for clinical rational drug use. Methods: "Xiaohe tablets" were selected as the search words and the China Hospital Knowledge Database (CHKD, 1994-2009)and Chinese Biomedical Literature Database (CBM, 1978-2009)were searched. The case reports of liver damage associated with Xiaohe tablets were collected and analysed. Results: A total of 194 patients were collected. All patients were women with age of 17 to 55 years. Of them, 68 were indicated the dosage of 2-7 pills thrice daily. The duration of drug use was 14-180 d. The patients presented with gastrointestinal symptoms such as nausea, abdominal distension after about 50 days of therapy and yellowish skin and sclera after 30-140 days of therapy. Biochemical test results were as follows: ALT 68-1 700U/L, AST 40-1 260 U/L, TBil 8.0-795.4 μmol/L, DBil 2.3-391.8 μmol/L. Of 194 patients, 10 underwent pathological examination of liver tissue, showing hepatocyte swelling, scanty cytoplasm, ballooning degeneration, and hepatocyte necrosis. Most patients restored gradually 10 days to 4 months after drug discontinuation. Of them, 190 (97.9%) were clinical cure, 3 (1.5%) improved, and 1 (0.5%) with acute liver failure died of septic shock. Conclusion: Xiaohe tablets can induce liver damage, and most of them are reversible; the liver damage may be related to dosage and duration of drug therapy; the drug should be avoided to use for patients having liver disease; and the patients’liver function should be closely monitored during the drug use.
  • 调查研究
    Liang Yan;Liu Xiao;Gao Bo;Zhang Haiyan;Cui Yimin
    . 2010, 12(5): 317-4.
    Objective: To investigate the adverse reactions caused by influenza A H1N1 vaccine and evaluate its safety. Methods: From October to December 2009, the medical professionals of Peking University First Hospital, who were vaccinated with influenza A H1N1 vaccine, were followedup within 3 months after vaccination. The baseline characteristics of medical professionals, the incidence, intensity, clinical manifestations, latency, and duration of adverse reactions as well as the relationship between the adverse reactions and allergic history of medical professionals were investigated and analyzed. Results: A total of 898 medical professionals were vaccinated. They comprised 226 men and 672 women with age of 18-87 [mean age (38±13) years]. The incidence of adverse reactions was 17.7% (158/898); of them, the men accounted for 14.6% (33/226) and women 18.8% (126/672) . There was no statistically significant difference in the incidence of adverse reactions between genders (χ2 =1.42, P=0.23).The incidence of adverse reactions in medical professionals with or without allergic history were 39.5% (17/43) and 16.6% (142/855), respectively. The difference was statistically significant (P<0.01). Of 159 persons who experienced adverse reactions, 67 experienced local reactions (42.1%) and its main manifestation was injection-site pain, 107 experienced systemic reactions including headache, sore throat, dizziness, asthenia, runny nose, fever, aching pain over the entire body, somnolence, and cough. The median latency and duration of local reactions were 0.08(0.02-8.00) hours and 48.00(1.00-720.00) hours, respectively. The median latency and duration of systemic reactions were 8.00(0.02-672.00) hours and 48(0.07-672.00) hours, respectively. The intensity of local and systemic reactions was mild to moderate, mainly mild (136/159, 85.5%). Conclusion: The adverse effects to influenza A H1N1 vaccine are mild and shorttime, and the vaccine is a relatively safe agent.
  • Zhou Yana;Zhu Shuqingb
    Adverse Drug Reactions Journal. 2010, 12(5): 351-2.
    A 60-year-old woman undergoing maintenance hemodialysis due to uremia received oral methotrexate 7.5 mg for arthralgia. Two days later, she developed generalised sporadic red rashes, sore throat, mouth ulcer, and sporadic ecchymosis in upper arms. Four days later, routine blood testing revealed the following levels: WBC count 0.6×109/L, RBC count 2.13×1012/L, Hb 69 g/L, PLT count 24×109/L, and reticulocyte count 0.1%. Bone marrow aspiration showed hypoplasia of granulocyte, red blood cell, and megakaryocytic series. She was treated with an IV infusion of methylprednisolone 80 mg, SC filgrastim 300 μg, an IV infusion of human immunoglobulin 2.5 mg, platelet 100,000 U transfusion, and symptomatic and supportive therapies. Subsequently, her symptoms improved gradually and her routine blood testing results returned to previous levels.
  • 病例报告
    ZHOU Xiao-ming;CHEN Yu;FENG Xue-wei;ZHAO Li
    . 2012, 14(4): 247-3.
    An 80-year-old male patient was given imipenem/cilastatin, vancomycin, caspofungin, micafungin, and meropenem for post-operative infections, but these had no effect. The treatment was then switched to an IV infusion of meropenem 1.0 g every 8 hours combined with an IV infusion of voriconazole 400 mg every 12 hours on the first day followed by 200 mg every 12 hours. On days 5-9 of treatment, the laboratory tests showed the following levels: serum creatine (SCr) 154-208 μmol/L, blood urea nitrogen (BUN) 24.3-35.9 mmol/L, serum cystatin C 4.54-5.44 mg/L, blood pH 7.18-7.34, Cl-122-130 mmol/L, K+3.4-4.1 mmol/L, standard bicarbonate 12-15 mmol/L, actual bicarbonate 13-14 mmol/L,anion gap 13-14 mmol/L. Urinalysis revealed the following levels: RBC count 3.8-4.8 cells/HP, protein ±, and pH 5.5. Acute renal tubular acidosis and acute renal injury were diagnosed. On day 9 of treatment, voriconazole administration was changed to a 200 mg intravenous infusion every morning and a 200 mg nasal feeding every night. But the patient presented with hyperchlorine acidosis and hypokalemia on day 3 after a change in administration and, on day 11, voriconazole was stopped and meropenem was continued. Two days after drug discontinuation, his SCr and BUN reached peak values of 282 μmol/L and 49.4 mmol/L, respectively. Subsequently, his SCr and BUN levels gradually decreased and normalized on days 25 and 34 after drug discontinuation, respectively. The blood gas analysis results basically returned to normal on day 25 after drug withdrawal.
  • 中药不良反应
    . 2007, 9(1): 58-59.
  • ADR咨询
    . 2004, 6(5): 352-352.
  • 病例报告
    Chen Guoqing;Zheng Guoyong
    . 2010, 12(1): 67-2.
    A 86yearold woman with hypertension, sequelae of cerebral infarction, and hyperlipemia received telmisartan, aspirin, nicergoline, simvastatin, Danhong injection, and deproteinized hemoderivative of calf blood injection. After 14 days of therapy, Danhong and deproteinized hemoderivative of calf blood injection were stopped and an IV infusion of meclofenoxate 0.25 g dissolved in 20 ml of sodium chloride 0.9% twice daily was added to his regimen. On the day of meclofenoxate administration, the patient experienced urinary frequency, urgency, and incontinence. Renal function revealed a BUN level of 7.10 mmol/L and a SCr level of 88 μmol/L. Meclofenoxate was withdrawn immediately and other medications were continued, his symptoms relieved gradually. Three days later, his condition was stable and he was discharged.
  • 病例报告
    Liu Ensheng;Chen Youguang;Li Yuzhen
    . 2007, 9(6): 428-429.
    A 52-year-old woman with rheumatoid arthritis received oral diclofenac potassium 50 mg thrice daily,oral bismuth potassium citrate 110 mg thrice daily,and IV technetium methylenediphosphonate [99mTc]-MDP injection 200 mg once daily.One week later,she developed nausea,vomiting,cough,and pharyngalgia.Her Cr increased from 95 μmol/L to 542 μmol/L,and her BUN increased from 6.76 mmol/L to 18.9 mmol/L.All drugs were withdrawn.She was treated with prednisolone,levofloxacin,and plasmapheresis.But her symptoms were not markedly relieved.Her Cr was 638 μmol/L and BUN was 25.8 mmol/L.A renal needle biopsy showed renal amyloidosis and acute tubular necrosis.After hemodialysis and symptomatic treatment,the patient's condition became stable.Her Cr decreased to 379~442 μmol/L,and BUN decreased to 12.3~20.76 mmol/L.At follow-up 1 year later,her renal function did not recover.
  • Jiang Yuyong, Meng Peipei, Wang Fei, Song Yuanyuan
    . 2015, 17(6): 440-443.
    The interferon is a commonly used drug which is used to treat viral hepatitis. Due to its significant role in the regulation of immune system, it can conduce to inflammatory bowel diseases, such as ulcerative colitis, Crohn's disease, and ischemic colitis. Interferon-related ulcerative colitis is more common, generally occurs from two weeks to several years after interferon therapy, the patients complain of abdominal pain and diarrhea, mucus stool is the main manifestation. A total colonoscopy shows diffuse mucosal edema, ulcer, and hyperemia. The patients are treated with mesalazine, sulfasalazine or glucocorticoids. Some patients may continue interferon therapy after the symptoms improved. Interferon-related Crohn′s disease is rare and the prognosis is poor. Interferon-related ischemic colitis lesions generally are confined to the descending colon,   long-term ulcers, mucosal edema and erosion bleeding. The symptoms are relieved within 2 weeks after interferon discontinuation and symptomatic therapy. Then interferon therapy can be continued.
  • Li Xianmin, Lin Fang, Mu Jingsong
    Adverse Drug Reactions Journal. 2020, 22(8): 494-495. https://doi.org/10.3760/cma.j.cn114015-20190408-00346
    A 27-year-old male patient mistakenly took an anti-obesity agent containing sibutramine. Two months later, the patient developed fever and myalgia. Two days later, his above symptoms were aggravated, and unconsciousness, rashes, and oliguria appeared. Laboratory tests showed serum creatinine 748-μmol/L, aspartate aminotransferase 299-U/L, alanine aminotransferase 102-U/L, total bilirubin 101.6-μmol/L, direct bilirubin 85.5-μmol/L, lactate dehydrogenase 3-070-U/L, myoglobin 12-081-μg/L, and creatine kinase 18-517-U/L. Rhabdomyolysis with multisystem injury caused by sibutramine was diagnosed. The anti-obesity agent was discontinued, and continuous renal replacement therapy and symptomatic and supportive treatments such as magnesium isoglycyrrhizinate, acetylcysteine, and terlipressin were given. After 2 weeks, the patient′s symptoms disappeared, the rashes subsided, and the liver and kidney functions and laboratory tests such as creatine kinase and myoglobin returned to normal.
  • Ren Jing, Zheng Yao
    Adverse Drug Reactions Journal. 2022, 24(11): 614-616. https://doi.org/10.3760/cma.j.cn114015-20220225-00162
    A 58-year-old male patient received subcutaneous injection of enoxaparin 4-000 U twice daily and continuous IV pump of tirofiban hydrochloride for injection 12.5-mg dissolved in 0.9% sodium chloride injection 250-ml at a speed of 5-ml per hour after coronary angiography and coronary stent implantation. Aspirin enteric coated tablets and clopidogrel bisulfate tablets were taken orally at the same time. Fifteen hours later, the patient developed bloody sputum and scattered bleeding spots on the trunk and extremities. Laboratory test showed platelet count (PLT) 1×109/L and extremely severe thrombocytopenia was considered. The above treatments were stopped immediately and 8 U of platelets were infused intravenously once. Next day, his PLT returned to 30×109/L, and clopidogrel bisulfate tablets were given again; on the 3rd day, his PLT returned to 57×109/L, and aspirin enteric coated tablets were given again; on the 6th day, his PLT returned to 144×109/L. According to heparin-induced thrombocytopenia scoring system, the patient′s score was 1, indicating that the possibility of heparin-induced thrombocytopenia was low, so it was considered that the patient′s extremely severe thrombocytopenia was probably caused by tirofiban.
  • Li Baojian, Hu Xiaoling, Yue Zichen
    Adverse Drug Reactions Journal. 2025, 27(3): 153-161. https://doi.org/10.3760/cma.j.cn114015-20240614-00446
    Objective To mine the adverse event (AE) risk signals of semaglutide and liraglutide in weight management populations, and provide references for the safe use of these drugs in relevant patients. Methods The reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, Bayesian confidence propagation neural network (BCPNN) method, and empirical Bayesian geometric mean (EBGM) method were used to mine the AE risk signals of semaglutide and liraglutide in weight management populations from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from the 1st quarter of 2010 to the 4th quarter of 2023. Adverse events that met the criteria of all 4 mining methods were considered as risk signals. The adverse events were classified and statistically analyzed using the system organ class (SOC) and preferred term (PT) of the 26.1 version of the Medical Dictionary for Regulatory Activities 26.1 version, and the identified risk signals were analyzed. Results During the set period, 2 292 AE reports for semaglutide for weight management (excluding diabetes) and 2 973 for liraglutide were retrieved. The semaglutide-related AE reports involved 83 PTs, among which 57 were already recorded in the instructions and 26 were not. Among the 26 PTs not recorded in the labels, the top 5 PTs in terms of AE report numbers were increased appetite, hunger, panic attack, binge eating, and feeling cold; the top 5 PTs in terms of ROR values were lack of satiety, hunger-induced ketoacidosis, myoglobinuria, binge eating, and bulimia. The liraglutide-related AE reports involved 74 PTs, among which 60 were already recorded in the instructions and 14 were not. Among the 14 PTs not recorded in the labels, the top 5 PTs in terms of AE report numbers were weight gain, increased appetite, binge eating, weight fluctuation, and pancreatic cyst; the top 5 PTs in terms of ROR values were lack of satiety, binge eating, hepatic adenoma, increased appetite, and pancreatic cyst. Three PTs of severe AEs that were not recorded in the labels for semaglutide were identified, namely, olfactory abnormality, ketoacidosis, and panic attack. One PT of severe AE that was not recorded in the labels for liraglutide was identified, namely, metastatic pancreatic cancer. Conclusion The AE risk signals of semaglutide and liraglutide in weight management include AEs not recorded in the labels, and some are even serious AEs, which need to be identified and prevented in clinical practice.
  • Adverse Drug Reactions Journal. 2020, 22(3): 215-216. https://doi.org/10.3760/cma.j.cn114015-20200312-00266
    1位29岁女性护士在治疗新型冠状病毒感染患者期间不慎被患者用过的针头扎破手指。因担心职业暴露感染口服洛匹那韦/利托那韦片(洛匹那韦200-mg/利托那韦50-mg)2片,2次/d。首次服药4 h后出现全身红色皮疹,伴颜面部肿胀。给予氯苯那敏片8-mg口服,地塞米松磷酸钠注射液5-mg肌内注射。服药后8.5-h患者出现大汗淋漓,面色苍白,伴腹痛、腹泻,血压70/50-mmHg(1-mmHg=0.133-kPa),体温35.2-℃,心率87次/min,呼吸22次/min,脉搏微弱,四肢发冷,血氧饱和度0.93。诊断为洛匹那韦/利托那韦致过敏性休克,给予静脉扩容、鼻导管吸氧及心电监护。患者症状逐渐缓解,2.5-h后患者血压恢复至108/89-mmHg,次日皮疹消退。
  • 病例报告
    Sun Ruifang;Liu Lei;Bai Yang
    . 2014, 16(1): 48-2.

    A 29-year-old woman underwent curettage and uterine artery embolization for cervical pregnancy and colporrhagia. Her physical and laboratory examination before operation showed normal liver function. The patient received paracetamol and dihydrocodeine tartrate 20 pills within 20 hours by herself because of postoperative pain. Laboratory tests on day 2 of drug use revealed the following levels: alanine aminotransferase (ALT) 263 U/L, aspartate aminotransferase (AST) 226 U/L. She was given tabellae glucurolactone 100 mg three times daily. On day 3 of drug use the patient developed nausea, vomit, and poor appetite. Laboratory tests on 4 day of drug use revealed the following levels: ALT 1 128 U/L, AST 1 006 U/L, total bilirubin 44.7 μmol/L. The patient was diagnosed as severe liver injury due to overdose of paracetamol and dihydrocodeine tartrate. She received an IV infusion of polyene phosphatidyl choline 930 mg dissoloved in 5% glucose injection 100 ml, compound glycyrrhrzin injection 80 ml plus 0.9% sodium chloride 250 ml, and reduced glutathione sodium 1.8 g dissoloved in 5% glucose injection 100 ml once daily. On day 9 of treatment of liver the patient′s diet return to normal, the symptoms of nausea and vomit were disappeared. Laboratory tests showed the following levels: ALT 404 U/L,AST 32 U/L. On 21 day of treatment of liver, laboratory tests showed the following levels: ALT 34 U/L,AST 18 U/L.

  • 论坛
    . 2014, 16(2): 68-3.
  • 论著
    Shi Xiujin;Wei Guoyi;Lin Yang;Zhang Haibo;Zhong Yu;Bai Yuguo;Zhou Yang;Jia Yixin
    . 2014, 16(3): 153-6.
    ObjectiveTo explore the correlation between polymorphisms of multidrug resistance 1(MDR1) gene and nephrotoxicity induced by cyclosporine (CsA) in heart transplant recipients. Methods
    The patients who received cardiac transplantation in Beijing Anzhen Hospital from January 2004 to December 2012, postoperative immunosuppression treatment with CsA, and follow-up for at least 12 months, were selected as subjects. All patients were divided into the kidney injury group and the no kidney injury group according as whether kidney injury occurred after CsA treatment. Leukocyte genomic DNA was extracted from the blood which was taken for CsA concentration monitoring after heart transplant. According to information sites in HapMap database, genotype and allele frequencies of 16 tags of MDR1 SNP were analyzed by matrix-assisted laser desorption ionization time of flight mass spectrometry (MALDI-TOF MS). SNP allele frequencies were compared with frequencies obtained from dbSNP database and non-conditional binary logistic regression analysis was used to analyze the correlation between the SNP genetic polymorphisms and kidney injury induced by CsA.ResultsA total of 65 patients were entered into this study. Of them, 19 patients were in the kidney injury group (17 males and 2 females) with age of 18-59 (44±13) years and 46 patients were in the no kidney injury group (39 males and 7 females) with age of 14-71 (42±15) years. There was no statistically significant difference in age and gender between the 2 groups (P>0.05 for all comparisons). According to MALDI-TOF MS detection results, the differences of allele frequencies in 16 tag SNP and corresponding data in dbSNP database, and the differences of allele frequencies in 16 tag SNP between the 2 groups were not statistically significant (all P>0.05). Based on the non-conditional Logistic regression analysis, there was no significant correlation between genetic frequency of MDR 1 in these 16 Tag SNP and the CsA nephrotoxicity in patients with kidney injury.ConclusionNo statistically significant correlation between MDR1 gene polymorphism and nephrotoxicity induced by cyclosporine in heart transplant recipients is found.
  • 病例报告
    Sun Fangli;Wu Jun;Jiang Lili;Xiao Shuxin;Teng Chunyuan
    . 2010, 12(2): 127-2.
    A 29-year-old man with chronic hepatitis B received IM interferon α-2b 3,000,000 IU every other day. Four months later, telbivudine 600 mg once daily was added to his regimen due to poor efficacy. At the ninth month of combination therapy, the patient experienced muscle aching pain and, at month 11, the two drugs were discontinued. At month 15, he developed nausea, vomiting, diarrhea, abdominal pain. Subsequently, constipation and upper abdominal pain after meal appeared and he was hospitalized. On admission, laboratory tests revealed the following levels: pH 7.25, lactic acid 11 mmol/L, and serum amylase 305 U/L. The treatments including fluid supplementation, anti-infection, and correction of acidosis were given. After 6 days of admission, his symptoms relieved.
  • 病例报告
    Pang shufang①;Miao Zhenli②
    . 2007, 9(4): 289-289.
    A 53-year-old woman with colpitis mycotica received an intravaginal application of nysfungin powder 1×106 U after the treatment with infrared instrument.Eleven hours later,she developed a high fever(T 39.2 ℃)and palpitation.An ECG showed sinus tachycardia.After symptomatic treatment,she recovered.The next day,the similar symptoms reappeared after she received nysfungin again,and she was cured after antianaphylaxis therapy.The nysfungin powder was replaced with miconazole suppositories 400 mg and then it was inserted into the vagina after treatment with infrared instrument.No such adverse reactions occurred.
  • 病例报告
    . 2007, 9(1): 27-27.
  • 药源性疾病
    WANG Xiao-fang;ZHANG Yun-jian;XIA Guo-guang
    . 2012, 14(4): 224-4.

    Drug-induced interstitial lung disease is the most common type of drug-inducedrespiratory diseases. It is known that a lot of drugs can cause interstitial lung diseases. The underlying mechanism may be associated with allergy and the direct cellular toxicity. Its clinical symptoms, imaging, and histopathology were untypical. Clinical diagnosis of the disease was based on the medical history (medication history), clinical features, chest imaging, histopathological changes, and response to treatment. If interstitial lung diseases were suspected to be drug-induced, the drug should be discontinued immediately and glucocorticoid could be given. The prognosis is good if intervention is rapid.

  • FAN Chun-lei;DONG Jin-ling;LI Lei;WU Yong-le;DING Hui-guo
    . 2013, 15(3): 170-2.

    Three patients with severe liver diseases and infections(all males, aged 40, 68, and 50, respectively)were treated with carbapenem, linezolid, and fluconazole. No obvious change of hemogram result was found during the period of drugs use. The therapy was replaced with an IV infusion of piperacillin sodium and tazobactam sodium 4.5 g every 8 hours due to poor efficacy. Patient 1 developed platelet count decrease and anemia after the treatment with piperacillin sodium and tazobactam sodium for 11 days. Patients 2 and 3 developed platelet count decrease and exacerbation of anemia after the treatment with piperacillin sodium and tazobactam sodium for 4 and 7 days, respectively. Three patients′ hemoglobin levels and plateletcounts apparently recovered on days 31, 21, and 7 after the discontinuation of medication, respectively.

  • SONG Li-xue;WANG Jin-ping;GAO Xin;XU Wei-dong
    . 2013, 15(3): 136-5.

    ObjectiveTo explore the correlation between UDP-glucuronosyltransferases 1 family polypeptide A(UGT1A)gene polymorphism and the adverse reactions induced by antineoplastic agent irinotecan, in order to provide a reference of individual therapy for patients with tumor.MethodsThe subjects were 233 healthy volunteers and 196 patients with tumor received irinotecan. The healthy volunteers comprised 169 male and 64 female with mean age of (25±5) years. Of the 196 patients with tumor, 92 had carcinoma of rectum, 45 had cervical carcinoma, and 59 had epithelial ovarian cancer. They comprised 54 male and 142 female with a mean age of (61±19) years. The gene polymorphism of UGT1A1*6, UGT1A1*28, UGT1A3*1, UGT1A3*2, UGT1A3*3, UGT1A3*4, and UGT1A9*22 were detected by pyrosequencing. The genotypic mutation frequency of UGT1A in subjects between the 2 groups were compared. The incidences of delayed diarrhea and neutropenia in patients with different UGT1A genotypes were compared. The risk factors of adverse reactions due to irinotecan were analyzed by Logistic regression analysis. The results were represented by odds ratio (OR) and 95% confidence interval (CI).ResultsThe UGT1A3*2 genotypic mutation frequency in the patients with tumor was significantly lower than that in the healthy volunteers (50.3% vs. 68.5%, P=0.014), and the UGT1A3 * 3 genotypic mutation frequency in the patients with tumor was significantly higher than that in the healthy volunteers (26.0% vs. 6.2%, P=0.001). The incidences of level Ⅱ-Ⅳ and Ⅲ-Ⅳdelayed diarrhea, and the neutropenia were 48.5% (95 cases), 11.2% (22 cases), and 49.0% (96 cases) in 196 patients with tumor, respectively. The incidences of level Ⅱ-Ⅳ and Ⅲ -Ⅳ delayed diarrhea in UGT1A1*28 wild type (WW) carriers were significantly lower than those in the mutant heterozygote (WM)+homozygous mutant (MM) genotype carriers [Ⅱ-Ⅳ: 40.4%(57/141)vs. 69.1%(38/55),P=0.006;Ⅲ-Ⅳ: 5.7%(8/141) vs. 25.5%(14/55),P=0.001]. The incidences of level Ⅱ-Ⅳdelayed diarrhea in UGT1A9*22 (WW) carriers were significantly lower than those in the WM and MM carriers [26.2%(17/65)vs. 47.6%(40/84),P=0.006;26.2%(17/65)vs. 51.1%(24/47)P=0.0057]. There were no statistical differences in incidences of level Ⅲ-Ⅳ neutropenia among the patients with different genotypes. Logistic regression analysis showed that UGT1A genotype was related to the delayed diarrhea(OR=5.657,95%CI: 4.782-7.245,P=0.039). ConclusionUGT1A1* 28 and UGT1A9* 22 gene polymorphism may increase the risk of delayed diarrhea induced by irinotecan.

  • . 2013, 15(3): 152-5.

    The efficacy of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI) is good in treatment for non-small-cell lung cancer. The commonly used EGFR-TKI in clinical are gefitinib, erlotinib, and icotinib in the present. With the wide application of EGFR-TKI, adverse drug reactions (ADR) associated with EGFR-TKI are studied deeply. The main ADR associated with EGFR-TKI are rash, paronychia, hair alterations, diarrhea, liver damage, interstitial lung disease, and so on. The mechanisms that lead to these adverse reactions are not clear. Symptomatic treatments should be given when the symptoms are mild and the dosage of EGFR-TKI should be reduced or withdrawn when the symptoms are severe in patients with more common adverse reactions such as rash and paronychia. Symptomatic therapy should be given and functions of the liver and lungs should be monitored regularly in patients with more serious liver damage or interstitial lung disease.

  • 临床论著
    Lin Na;Li Tianzuo**;Lin Hong;Zhang Bingxi
    . 2010, 12(4): 229-5.
    Objective: To observe postoperative recovery and adverse reactions after application of sevoflurane inhalation anesthesia with laryngeal mask and ketamine intravenous anesthesia in ambulatory children undergoing eye surgery in order to compare the anesthetic effectiveness and safety of the two different types of anesthetic agents. Methods: Two thousand seven hundred and seventythree children aged from 4 months to 14 years undergoing cataract, glaucoma, strabismus, ophthalmoplasty, retina, or corneal surgeries at Beijing Tongren Hospital from January to December 2008 were divided into the following two groups: the sevoflurane inhalation anesthesia with laryngeal mask group (the sevoflurane group, n=1 074) and the ketamine intravenous anesthesia group(the ketamine group, n=1 699). The sevoflurane group comprised 698 boys and 376 girls with average age of (4.0±3.0) years. The ketamine group comprised 1 056 boys and 643 girls with average age of (5.4±3.0)years. The children in sevoflurane group received sevoflurane inhalation by mask, and its concentration was increased from 5% to 8% with an oxygen flow rate of 5 L/min. After the patients lost consciousness, venipuncture was established and then the laryngeal mask was inserted, and sevoflurane 1.5%-2.5% was given for maintenance anesthesia during the surgery. The children in the ketamine group received ketamine 2 mg/kg in 10 mL of 0.9% sodium chloride injection intravenously after venipuncture was established, and ketamine 0.5-1.0 mg/kg was given intermittently for maintenance anesthesia during the surgery. Aldrete Scores, PACU length of stay, and adverse reactions during intraoperation period were recorded and analyzed. Results: The children having a score of 10 were discharged from PACU. The length of PACU stay of patients was (23.6±16.1) min and (56.2±34.9) min in the sevoflurane and ketamine groups, respectively. The difference was statistically significant (P<0.01). There was no significant difference in length of PACU stay of patients undergoing different types of surgeries in the sevoflurane group (P>0.05). While the length of PACU stay of patients undergoing phacoemulsitication, intraocular lens implantation, and ophthalmoplasty was shorter than that of patients undergoing strabismus surgery. The difference was statistically significant (P<0.05). Ninety percent of patients in the sevoflurane group developed tachycardia which normalized within 10 seconds during induction of anesthesia. Six patients’SpO2 in the ketamine group was less than 92% during surgery. The incidence of postoperative agitation was 47.6% (511 cases) and 39.8% (676 cases) in the sevoflurane and ketamine groups, respectively. The incidence of nausea and vomiting was 8.4% (90 cases) and 10.2% (173 cases) in the sevoflurane and ketamine groups, respectively. The difference was not statistically significant (P>0.05). Conclusion: Sevoflurane inhalation anesthesia with laryngeal mask has higher anesthetic effectiveness, more rapid recovery after surgery, and has less adverse reactions compared with ketamine intravenous anesthesia; and it is suitable for non-hospitalized children undergoing eye surgery.
  • 安全用药
    Wang Boya;Yan Suying
    . 2011, 13(2): 99-4.
    Linezolid is an oxazolidinone antibacterial used for the treatment of Grampositive infection of the respiratory tract and skin, including those due to vancomycin resistant enterocooci. The common adverse reactions are diarrhea, nausea, vomiting, headache, and rash. Linezolid may cause thrombocytopenia, and the risk factors for thrombocytopenia are prolonged use of linezolid, advanced age, and renal insufficiency. The mechanism of thrombocytopenia induced by linezolid might be linked to bone marrow suppression or immunemediated platelet decrease. The measures for prevention and treatment of thrombocytopenia are as follows: highdose and prolonged use of linezolid should be avoided; platelet count should be closely monitored during linezolid therapy; linezolid combined with drugs that produce bone marrow suppression should be avoided; linezolid therapy should be discontinued in patients who developed thrombocytopenia, and transfusion of platelets should be considered in patients having severe thrombocytopenia.
  • 病例报告
    . 2005, 7(5): 354-354.
  • 病例报告
    . 2002, 4(1): 19-19.
  • 病例报告
    . 2002, 4(1): 52-52.
  • 中毒救治
    . 2003, 5(2): 98-100.
  • 安全信息
    . 2010, 12(1): 71-1.
  • 病例报告
    Zhang Bin;Dong Peiling;Ding Huiguo
    . 2008, 10(4): 0-0.

    A 35yearold man with chronic hepatitis B took adefovir 10 mg/day. Three months later, his liver function returned to normal; fifteen months later, his HBV DNA level was <1×103 copies/ml. However, his HBeAg was still positive. After two years of treatment, adefovir was withdrawn by himself. After forty days of adefovir discontinuation, the man developed fatigue and anorexia. Laboratory testing showed the following results: ALT 1 884.9 U/L, AST 1 135.4 U/L, TBil 42.8 μmol/L, DBil 16.8 μmol/L, HBV DNA 1.27×107 copies/ml. Viral rebound due to adefovir withdrawal was suspected. Subsequently he was admitted to hospital and given oral entecavir 1 mg/day and liverprotective and symptomatic therapy. However, the patient's symptoms became aggravated gradually, and deepening jaundice occurred. Laboratory investigations revealed the following values: TBil 428 μmol/L, PTA 13.8%, INR 5.8. He was diagnosed with hepatic failure. Despite treatment with nonbiotype artificial liver and plasmapheresis, his condition deteriorated further, and hepatic encephalopathy occurred. Finally he died of hepatic failure.

  • 病例报告
    He Yong;Xu Xiuyun
    . 2008, 10(2): 147-2.

    A 39yearold woman with onychomycosis took ketoconazole combined with griseofulvin for more than 2 months. Two months after discontinuation of the drugs, she developed severe yellowish in the skin and sclera. Liver function tests showed the following levels: ALT 564 U/L,AST 621 U/L,TBil 387 μmol/L. An ultrasound B examination revealed an increased liver echo intensity and a small amount of hydrops in abdominal cavity. She was diagnosed with severe subacute hepatitis. After admission, despite receiving liverprotective and symptomatic therapy as well as plasmapheresis, her liver damage progressively worsened. She died after discharge.

  • 实验论著
    Shen Lianzhong;Zhou Xiaobing;Liu Li;Qi Weihong;Li Xin;Jiang Hua;Wang Chao;Geng Xingchao;Li Bo
    . 2009, 11(4): 237-6.

    Objective: To study the causes of neurological damage event related to some cytarabine preparations manufactured by Shanghai Hualian Pharmaceutical Factory in order to improve the manufacture and administration of medicinal products. Methods:The animals for the experiment were cynomologus monkeys, rhesus monkeys, and Beagle dogs. The drugs for testing include neurological damage event-related cytarabine (or event-related cytarabine for short), non-neurological damage event-related cytarabine (or non-event-related cytarabine for short), vincristine, and normal saline. The route of administration was intrathecal (lumbar) injection. Sixteen cynomolgus monkeys were divided into four groups (4 monkeys in each group): the normal saline 0.5 ml group, the non-event-related cytarabine 20 mg group, the eventrelated cytarabine 10 mg group, and the eventrelated cytarabine 20 mg group. Fifteen rhesus monkeys were divided into five groups (3 monkeys in each group): the nonevent-related cytarabine 20 mg group, the eventrelated cybarabine 20 mg group, the non-event-related cytarabine 20 mg plus vincristine 8 μg group, the noneventrelated cytarabine 20 mg plus vincristine 80 μg group, and the vincristine 200 μg group. Twenty-two Beagle dogs were divided into seven groups (4 dogs in the event-related cytarabin 40 mg group and 3 dogs in each other groups): the normal saline 2 ml group, the non-event-related cytarabine 40 mg group, event-related cytarabine 40 mg group, non-event-related cytarabine 40 mg plus vincristine 16 μg group, non-event-related cytarabine 40 mg plus vincristine 160 μg group, the vincristine 16 μg group,and the vincristine 160 μg group. Results:In the cynomologus monkey experiments: 2 monkeys in the event-related cytarabine 10 mg group and 3 monkeys in the event-related cytarabine 20 mg group developed poor coordination in lower limbs and bradykinesia; one monkey in the event-related cytarabine 10 mg group was moribund 42 days after drug administration and 2 monkeys in the eventrelated cytarabine 20 mg group were moribund 23 days and 42 days after drug administration, respectively. In the rhesus monkey experiments: one monkey 12 days after drug administration and two monkeys 41 days after drug administration were moribund in the event-cytarabine 20 mg group; one monkey in the non-event-related cytarabine 20 mg plus vincristine 8 μg group was moribund 21 days after drug administration; two monkeys in the non-event-related cytarabine 20 mg plus vindristine 80 μg group were moribund 10 days and 21 days after drug administration, respectively; three monkeys in the vincristine 200μg group died 12-15 days after drug administration. In Beagle dog experiments: four dogs in the event-related cytarabine 40 mg group and two dogs in the non-event-related cytarabine 40 mg plus vincristine 16μg developed difficulty walking 9-13 days after drug administration; two dogs in the non-event-related cytarabine 40 mg plus vincristine 160μg group were moribund 6-7 days after drug administration; three dogs in the vincristine 160 μg group were moribund 4-12 days after drug administration. No neurological damage symptoms were observed in the normal saline and non-event-related cytarabine groups. Conclusion: Intrathecal (lumbar) injection of a vincristine-containing cytarabine preparation can cause neurological damage.

  • 临床论著
    Ge Feijiao;Liu Jianzhi;Qiu Hui;Liu Liejun;Wang Yan;Zhao Chuanhua;Li Zhiqiang;Xu Jianming
    . 2009, 11(2): 77-5.
    Objective: To investigate clinical efficacy and safety of morphine sulfate suppositories in treatment of moderate to severe cancer pain. Methods: A multicentre randomized double-blind, placebocontrolled study was conducted. Form March 2005 to March 2006, a total of 132 patients with moderate to severe cancer pain was enrolled in the study. The patients were divided into two groups: the treatment group (66 cases) and the control group (66 cases). The treatment group comprised 35 men and 31 women with average age (52.8±11.9) years. The control group comprised 46 men and 20 women with average age (58.2±10.9) years. The patients in the treatment group were administered 1 morphine sulfate 20mg suppository by rectum and 1 placebo tablet by mouth. The patients in the control group were administered 1 morphine sulfate 20mg tablet by mouth and 1 placebo suppository by rectum. The patients were administered the second dose when the moderate pain recurred. The daily dose was not more than 100 mg. The duration of treatment was 7 days. The analgesic efficacy and adverse reactions to morphine sulfate suppositories were assessed. Results: Baseline pain intensity measured with visual analogue scale in the treatment and control groups was 7.1±1.3 and 6.8±1.2, respectively. The difference was not statistically significant (P > 0.05). The pain intensity in patients in both groups decreased 15 and 30 minutes, 1.0, 1.5, 2.0, 3.0, 4.0, and 6.0 hours after administration, compared with before administration. The difference in pain intensity between before administration and at different time points after administration was as follows: after the first administration, it was respectively 0.80±1.33, 2.09±1.77, 3.27±1.92, 4.14±2.05, 4.26±2.13, 3.70±2.09, 3.27±2.11, and 2.88±2.35 in the treatment group and 0.74±1.41, 197±1.93, 3.15±2.11, 3.82±2.16, 3.95±2.13, 3.52±2.12, 3.00±2.19, and 2.70±2.23 in the control group; after the second administration, it was respectively 0.92±1.37, 5.35±1.53, 3.05±1.94, 3.38±1.85, 3.70±2.02, 3.52±2.00, 3.05±2.06, and 2.84±2.22 in the treatment group and 0.72±1.03, 4.95±1.49, 2.77±1.84, 3.27±1.98, 3.27±1.95, 3.05±1.77, 2.67±1.68, and 2.25±1.88 in the control group. The differences in pain intensity before and after treatment in both groups were statistically significant (all P<0.001). But there was no statistically significant difference in the pain intensity between the two groups (all P>0.05). The response rate to analgesia in both groups was 71.21%, the pain intensity in the treatment and control groups was respectively 2.74 and 2.86 two hours after the first injection and 4.12 six hours after the first injection. The times of administration in the treatment and control groups were respectively 2.542.97 and 2.523.03 from day 2 to day 7. The differences in the response rate, pain intensity, and times of administration between both groups were not statistically significant 2 and 6 hours after administration (all P >0.05). The incidence of adverse reactions was 27.27% in both groups. The main adverse reactions in the treatment and control groups were vomiting (13.64% vs 9.09%), nausea (10.61% vs 10.61%), constipation (6.06% vs 7.58%), somnolent (3.03% vs 6.06%), dizziness (3.03% vs 6.06%), skin pruritus (1.52% vs 1.52%). The differences between both groups were not statistically significant (P > 0.05). Diplopia (1.52%) and rectal tenesmus (1.52%) occurred in the treatment group; respiratory depression (1.52%) and finger tip convulsion (1.52%) occurred in the control group. Conclusion: Analgesic efficacy of morphine sulfate suppositories is similar to morphine sulfate tablets. It is a more tolerable, safe, and effective dosage form for treatment of moderate to severe cancer pain.
  • 病例报告
    Xu Li;Li Chunrong;Liang Aimin
    . 2009, 11(2): 129-1.
    A 75yearold man was hospitalized with dizziness, asthenia, fever, and cough. Acute myelomonocytic leukemia was diagnosed. Filgrasting and tretinoin were given. Fifteen days after hospitalization, his chronic pulmonary obstruction was exacerbated. He was treated with mezlocillin, cefazolin sodium pentahydrate, and cefoperazonesulbatam, and subsequently his symptoms relieved. After a further 16 days, laboratory testing revealed the following: WBC 4.38×109/L, N 0.71, and SCr 78 μmol/L. He had a body temperature of 38.5℃. The patient received an IV infusion of norvancomycin 800 mg once every 12 hours for 7 days. On day 5 of therapy, he presented with a marked reduction of urine volume which was 600 ml/day. On day 7, his urine volume decreased to 300 ml/day. His SCr was 362 μmol/L. Urinalysis revealed protein (+) and erythrocytes(+). Norvancomycin was stopped and diuretics were given. Two days later, his renal function normalized and his SCr was 120 μmol/L.
  • 安全信息
    . 2009, 11(1): 71-1.
  • 论著
    Du Yuanyun;Zhu Wei;Lian Shi;Feng Jingchun;Zhao Guang;Liu Quanzhong
    . 2009, 11(1): 1-4.
    Objective: To observe and evaluate the clinical efficacy and safety of capsaicin liniment in treatment of patients with postherpetic neuralgia. Methods: A multicenter, randomized, doubleblind, placebocontrolled study was performed. Between September 2005 and December 2007, Two hundred and forty patients with postherpetic neuralgia who met the selection criteria were enrolled in this study. Of the 240 patients, 231 met the intentiontotreat analysis and entered the efficacy evaluation. The 231 patients were randomly divided into two groups: the treatment group (117 cases) and the control group (114 cases). The treatment group comprised 52 men and 65 women [average age (59.23±10.12) years, mean disease duration 5(1, 398) months]. The control group comprised 53 men and 58 women [3 patients' sex not stated, average age (57.44±11.32) years, mean disease duration 5(1,110) months]. The patients in the treatment group applied 0.075% capsaicin liniment and the patients in the control group applied its inactive vehicle liniment. The 0.075% capsaicin liniment and its inactive vehicle liniment were applied to the area of postherpetic neuralgia three times a day, respectively. The treatment duration was 2 weeks. A return visit examination was performed once a week. The efficacy, adverse reactions and changes in routine blood, routine urine, liver and renal function tests were observed. Results: Twentyeight patients were lost to followup (no evaluating data in 3 cases in the treatment group and 6 cases in the control group). The total effective rate to postherpetic neuralgia in the treatment and control groups were 86.32% (101/107) and 31.58% (36/114), respectively. The difference between the two groups was statistically significant (P<0.05). The main adverse reactions were a burning skin sensation, local redness and swelling. The incidence of adverse reactions in the treatment and control groups were 9.17% (11/120) and 8.33% (10/120), respectively. There was no statistically difference between the two groups (P>0.05). Conclusion: Capsaicin liniment is an effective and relatively safe agent in treatment of postherpetic neuralgia.
  • 中毒救治
    . 2002, 4(6): 390-393.
  • 病例报告
    . 2006, 8(4): 293-294.
  • 病例报告
    . 2004, 6(6): 412-412.
  • 综述
    . 2002, 4(3): 145-149.
    随着拉米夫定在我国慢性乙型肝炎治疗中的广泛应用,引起的HBV变异性耐药已成为越来越突出的问题。本文重点综述了近年来有关拉米夫定相关性变异的发生机制,发生率,影响变异样出现的可能因素,变异后对乙型肝炎的影响及拉米夫定相关性变异的防治。
  • 专题讲座
    . 1999, 1(1): 63-64.
  • 病例报告
    . 2000, 2(3): 188-189.
  • 病例报告
    HOU Xiao-ping;ZHOU Yun-fei
    . 2012, 14(5): 310-3.
    An 86-year-old man received one flupentixol and melitracen tablet once daily for suspected anxiety disorder. After starting treatment, he gradually developed listlessness, somnolence, weakness, and anorexia. On days 19, he developed nausea. On days 28, his symptoms progressed to dysphagia, inability to stand or walk, slow response. Serum electrolyte test showed the followed levels: potassium 40 mmol/L, sodium 121 mmol/L, chlorine 84 mmol/L. Hyponatremia and hypochloremia were diagnosed. Flupentixol and melitracen tablets decreased to 1/2 tablet once daily. The next day, his mental status and appetite improved remarkably. One week later, flupentixol and melitracen tablets decreased to 1/4 tablet once daily. Two weeks later, flupentixol and melitracen tablets was discontinued. The patient returned to normal. A repeat serum electrolyte test showed a potassium level of 4.3 mmol/L, a sodium level of 135 mmol/L, and a chlorine level of 98 mmol/L.
  • 病例报告
    . 2007, 9(1): 54-55.
  • 病例报告
    . 1999, 1(3): 185-185.
  • 病例报告
    . 2007, 9(2): 116-116.
  • 病例报告
    Yu Xiongjie;Wang Linxia;Liu Shengyou
    . 2010, 12(2): 134-2.
    A 41yearold man received an IV infusion of sodium fusidate 0.5 g every eight hours for pulmonary infection after undergoing an operation of delayed sternal closure. On day 3 after drug administration, the patient developed yellowish skin and sclera. Bultrasound showed an increase in liver volume. Laboratory tests revealed the following levels: ALT 68 U/L, AST 43 U/L, ALP 58 U/L, γ-GT 42 U/L, TBil 121.8 μmol/L, and DBil 73.3 μmol/L. Sodium fusidate was stopped and switched to vancomycin. Meanwhile he was given symptomatic therapy. Three weeks later, his liver function returned to within normal range.
  • Sun Limei, Su Haitao, Wang Hairong
    . 2015, 17(5): 330.
    ObjectiveTo find out the therapeutic scheme which was effective and made less injury for liver in patients with pulmonary tuberculosis complicated with hepatitis B.MethodsThe clinical data of patients with pulmonary tuberculosis and hepatitis B who received combination therapy of 3HLVE/6HLE (H: isoniazid; L: rifapentine; V: levofloxacin; E: ethambutol) or 3HRZE/6HRE (R: rifampicin; Z: pyrazinamide) in Qingdao Chest Hospital from January, 2010 to December, 2013 were collected and analyzed retrospectively. The patients were divided into the observation group and the control group. The patients in the observation group received combination therapy of 3HLVE/6HLE (H, L, V, and E were given for 3 months as the intensifying period and then H, L, and E for 6 months as a consolidation period), while the patients in the control group received combination therapy of 3HRZE/6HRE (H, R, Z, and E were given for 3 months as the intensifying period and then H, R, and E for 6 months as the consolidation period). The patients in the 2 groups received silibinin capsules at the same time. The patients′serum alanine aminotransferase (ALT) levels, serum total bilirubin (TBil) levels, the sputum bacterial negative conversion rate, and the efficiency of lesion absorption after 3 or 6 months of treatments were recorded and the incidence of liver injury and efficacy of anti-tuberculosis scheme between the 2 groups were compared.ResultsA total of 102 patients in accordance with the inclusion criteria were collected. Of them, 50 cases were in the observation group and 52 cases in the control group. There were no statistically significant differences in patients′age, gender distribution and tuberculosis lesions between the 2 groups (P>0.05). The incidence of liver injury in the observation group (26.0%, 13/50) was lower than that in the control group (46.2%, 24/52) (P<0.05); the degree of liver injury in the observation group[ALT:(81.6±8.5)U/L vs.(92.0±14.7)U/L; TBil :(22.5±10.2)μmol/L vs.(36.8±14.5)μmol/L]was lower than that in the control group (P<0.05); the time to liver function normal-ization in the observation group (15.4±3.1 d) was shorter than that in the control group (18.2±3.9 d) (P<0.05). After 3 months of treatment, the sputum bacterial negative conversion rate in the observation group (85.4%, 35/41) was higher than that in the control group (64.1%, 25/39) (P<0.05). After 6 months of treatment, the difference of the sputum bacterial negative conversion rate between the 2 groups was not statistically significant (P>0.05). After 3 or 6 months of treatment, the differences of the efficiency of lesion absorption between the 2 groups was not statistically significant (P>0.05). ConclusionAnti-tuberculosis scheme of 3HLVE/6HLE was a better therapeutic scheme in the early stage in patients with pulmonary tuberculosis and hepatitis B, which was more effective and made less liver injury.
  • Tang Airong, Shen Wei
    . 2017, 19(4): 298.

    A 58-year-old female patient with sour regurgitation, pyrosis, nausea, and vomiting received an IV infusion of esomeprazole sodium for injection 40 mg once daily. Before treatment, her white blood cell (WBC) count was 4.5×109/L and neutrophil (NEUT) count was 2.8×109/L. On day 2 of medication, her WBC was 3.4 ×109/L and NEUT 1.7×109/L. On day 7, the patient′s WBC was 2.1×109/L and NEUT 0.1×109/L. On day 10, her WBC was 1.6 ×109/L and NEUT 0×109/L, she developed chillness and fever (38.4 ℃). On day 11, her temperature reached 40 ℃ with throat discomfort. She was diagnosed with neutropenia combined with upper respiratory infection due to esomeprazole sodium for injection. Esomeprazole sodium for injection was stopped and meropenem for anti-infection and recombinant human granulocyte colony-stimulating factor for increasing neutrophil were given at the same day. On day 3 of drug withdrawal, her temperature descended to 36.4 ℃. On day 4, her WBC was 2.3×109/L and NEUT 0.8×109/L. On day 10, her WBC increased to 8.0 ×109/L and NEUT 4.9×109/L.

  • Zhan Shipeng, Tang Min
    . 2017, 19(2): 142-143.

    A 20-year-old male with athetosis received sodium valproate 500 mg twice daily. Twenty days after treatment, the patient developed general erythematous which faded after pressing, increased skin temperature, facial swelling,  and enlargement of superficial lymph node in his head and neck. Laboratory tests showed the following values: white blood cell (WBC) 18.3×109/L, neutrophils 0.392, lymphocytes 0.364, monocytes 0.137, eosinophils 0.097, procalcitonin (PCT) 0.3 μg/L, alanine aminotransferase (ALT) 311 U/L, aspartate aminotransferase (AST) 148 U/L, alkaline phosphatase (ALP) 295 U/L, gamma-glutamyl transferase (γ-GT) 169 U/L. The patient was diagnosed as drug induced hypersensitivity syndrome (DIHS). Valproate was withdrawn. He received the symptomatic treatments which included glucocorticoid, antihistamines, liver protection and topical medication. Twenty days later, his erythematous rash were disappeared mainly. Fifty-five days later, his erythematous rash disappeared completely. Laboratory tests showed the following values: WBC 8.6×109/L, eosinophils 0.005, ALT 32 U/L, AST 22 U/L, ALP 66 U/L, γ-GT 67 U/L.

  • Adverse Drug Reactions Journal. 2020, 22(3): 151-154. https://doi.org/10.3760/cma.j.cn114015-20200305-00221
    新型冠状病毒肺炎(COVID-19)的患者中一些病例合并细菌和/或真菌感染,但实际中,使用抗菌药物的比例较高。我国《新型冠状病毒肺炎诊疗方案》中指出:“避免盲目或不恰当使用抗菌药物,尤其是联合使用广谱抗菌药物”。本文根据以往在严重急性呼吸综合征、中东呼吸综合征治疗中的经验和目前发表的COVID-19相关文献中细菌和真菌感染以及抗菌药物应用的情况,提出在COVID-19治疗中抗菌药物的应用应遵循以下原则:(1)对尚未确诊的患者在病因不明且不能排除细菌感染时,可短期经验性使用抗菌药物;(2)对已经确诊的COVID-19患者,在没有细菌感染证据的情况下应避免预防性使用抗菌药物;(3)有医院内感染证据的COVID-19患者应根据病原学检查,选择适当的抗菌药物。
  • Pan Daiyong, Jiang Baoyu, Huang Xiuyun
    Adverse Drug Reactions Journal. 2020, 22(4): 252-256. https://doi.org/10.3760/cma.j.cn114015-20190202-00115
    Objective To understand the condition of the cognition and behavioral intention of the public on adverse drug reactions (ADRs). Methods On-the-spot questionnaire survey was conducted, using self-designed paper and WeChat questionnaires, on patients or their family members who were waiting to see a doctor or get medicine in the outpatient department in the First Affiliated Hospital of Guangxi University of Science and Technology from September to December, 2018. The respondents filled in the questionnaires anonymously and the on-site questionnaire recovery was conducted. Qualified questionnaires were screened out by 2 pharmacists. A score and its percentile one were given for each question about the cognition and behavioral intention of ADRs in the questionnaires, and the results were statistically analyzed. Results A total of 519 questionnaires were collected, of which 508 were qualified, and the effective recovery rate was 97.9%. The median scores of the cognition and behavioral intention of respondents on ADRs were 50 (0, 100) and 86 (36, 100), respectively. Both the scores of cognition and behavioral intention on ADRs in the elderly respondents ≥60 years of age were lower than those in the respondents with 20-39 and 40-59 years of age (P>0.05 for all). Both the scores of cognition and behavioral intention on ADRs in the respondents with college/university degree were significantly higher than those in the respondents with middle school/secondary professional degree (P>0.05 for all). Both the scores of cognition and behavioral intention on ADRs in the urban respondents were significantly higher than those in the suburban and rural respondents (P>0.05 for all). Only 55.9% (284/508) of the respondents knew the right answer to the definition of ADRs, 44.1% (224/508) of the respondents thought that ADRs were caused by medication errors, drug quality, or medical errors, and 62.6% (318/508) of the respondents thought that hospitals, drug manufacturers, and drug regulatory departments should be responsible for the ADRs. After the occurrence of ADRs, 91.9% (467/508) of the respondents expressed their willingness to report it to the relevant departments, but 25.6%(130/508) of them did not know which department the ADRs should be reported to or how to fill in the report form. Conclusions The cognition of the public on ADRs was relatively lower. Although there was an intention to report ADRs, it was limited by the lower cognition and the lack of know- ledge of ADRs reporting departments and channels.
  • Liu Kexin, Chen Wenying, Lao Haiyan
    . 2016, 18(5): 377.
    A 71-year-old woman with acute kidney injury complicated with acute left heart failure received IV infusion of cefoperazone sulbactam sodium (cefoperazone 1000 mg plus sulbactam 500 mg dissolved in 0.9% sodium chloride injection 100 ml, once per 12 hours) because of pulmonary infection. The laboratory tests before taking the medicine revealed the following results: activated partial thromboplastin time (APTT) 43.7 s, prothrombin time (PT) 14.8 s, international normalized ratio (INR) 1.16, fibrinogen (FIB) 5.86 g/L. The results of reexamining in the morning of  day 6 of drug administration showed APTT 84.3 s, PT 54.9 s, INR 6.00, FIB 3.38 g/L. She was diagnosed as dysfunction of blood coagulation due to cefoperazone sulbactam sodium. Cefoperazone sulbactam sodium was stopped the same day, change with IV infusion of imipenem and cilastatin and intravenous injection of vitamin K1. The results of reexamining in the  afternoon of  day of change  medical prescription showed APTT 42.6 s, PT 15.1 s, INR 1.19, FIB 3.55 g/L. On day 6 of cefoperazone sulbactam sodium withdrawal, the results of reexamining showed APTT 34.9 s, PT 13.6 s, INR 1.05, FIB 3.56 g/L.
  • Bao Yushuang, Wang Chunyan, Du Shuhua, Song Wei
    . 2016, 18(2): 152.
    A 74-year-old male patient with urinary tract infection received an intravenous infusion of levofloxacin 0.3 g twice daily. On day 4, the patient developed muscular soreness in bilateral crus. The next day, the patient′s symptom of muscle pain became worse accompanied by waist and back pain and the urine was brown with decreased urine volume. Laboratory tests revealed the following results: alanine aminotransferase (ALT) 1 487 U/L, aspartate aminotransferase (AST) 106 U/L, γ-glutamine transferase (γ-GT) 94 U/L, total bilirubin (TBil) 37.4 μmol/L, direct bilirubin 25.2 (DBil) μmol/L, creatine kinase (CK) 1 446 U/L, lactate dehydrogenase (LDH) 414 U/L, alpha-hydroxybutyric dehydrogenase (α-HBDH) 464 mmol/L, creatine kinase isoenzyme (CK-MB) 34 U/L,  serum creatinine 397 μmol/L, blood urea nitrogen (BUN) 28 mmol/L, uric acid (UA) 823 mmol/L, carbon dioxide combining power (CO2CP) 17 mmol/L, urine occult blood (+++), urine protein(+++), microscopic examination of white blood cell 3-5/HP. The patient was considered to have rhabdomyolysis with acute renal failure induced by levofloxacin. Levofloxacin was withdrawn, and he received the supplement of fluid, alkalinization of urine, diuretic and liver protection therapy. Two days later, the patient′s urine volume increased. One week later, the muscle pain disappeared. Eight days later, laboratory tests revealed the following results: ALT 48 U/L, AST 39 U/L, γ-GT 60 U/L, TBil 19.6 μmol/L, DBil 11.5 μmol/L, CK186 U/L, LDH 235 U/L, α-HBDH 160 mmol/L, CK-MB 22 U/L, SCr 98 μmol/L, BUN 7.8 mmol/L, UA 397 mmol/L, CO2CP21 mmol/L.
  • 病例报告
    Liu Min;Yi Wei;Cai Haodong
    . 2010, 12(2): 130-2.

    A 31yearold woman received telbivudine 600 mg once daily for chronic viral hepatitis B. After 10 months of therapy, SC interferon 3 million units every other day was added to her regimen. After 9 months of treatments, interferon was stopped and telbivudine was continued. The patient developed numbness in both lower limbs and her symptoms aggravated. Subsequently, she experienced obvious myalgia, weakness in lower extremities, and paresthesia. Physical examinations showed slight hypoalgesia in peripheral extremities, weak tendon reflex in both lower limbs, slightly pale skin in her distal lower extremities, and grey nail in left hallux. Laboratory test showed a CK level of 1 694.3 U/L. Motor nerve conduction velocity tests revealed increased latency and decreased amplitude in her distal left nerus peroneus communis; sensory nerve conduction velocity tests revealed slow velocity in her left tibial nerve. Telbivudine was withdrawn and switched to lamivudine. Meanwhile she was treated with vitamin B1 and coenzyme Q10. Two months later, her symptoms improved.

  • 病例报告
    Yang Shizhen
    . 2009, 11(5): 372-1.
    A one-year-old female child was hospitalized with infectious diarrhea complicated by mild dehydration. Ceftriaxone and ribavarin were given. On day 4 after admission, furazolidone 30 mg thrice daily was added to the regimen due to poor control of infections. Three days later, the patient presented with yellowish skin and sclera. Liver function examination revealed following levels : ALT 196 U/L, AST 67 U/L, TBil 71.2 μmol/L, DBil 61.4 μmol/L, IBil 9.8 μmol/L. Furazolidone was stopped, ceftriaxone and ribavarin were continued, and symptomatic therapy was given. One week later, her jaundice disappeared and liver function normalized.
  • Wang Liru;Zheng Yi;Chen Yijuan;Wang Xin;Shi Bin
    Adverse Drug Reactions Journal. 2009, 11(5): 363-3.
    Two patients with chronic renal insufficiency developed encephalopathy due to cefepime for pulmonary infections. Patient 1, a 56-year-old woman received an IV infusion of cefepime 2.0 g twice daily. Two days later, the patients developed apathy, cognitive disorder, abnormal behavior, insomnia, involuntary limb tremor. On day 4, his symptoms were aggravated. Electroencephalogram revealed persistent slow waves and frequent triphasic waves. Cefepime was stopped and hemodialysis was given immediatedly. Two days later, his symptoms improved.Patient 2, a 22-year-old man was treated with an IV infusion of cefepime 2.0 g once every 8 hours. On day 5 of therapy, the patient developed abnormal speech, abnormal behavior, congnitive disorder, and involuntary limb tremor. Cefepime was stopped and hemodialysis was given. After further 2 days, his symtoms disappeared.
  • 病例报告
    . 2007, 9(2): 132-133.
  • 安全信息
    . 2013, 15(2): 82-1.
  • DONG Yan
    . 2013, 15(5): 292-2.
    A 69-year-old woman with hypertension received oral tizanidine for muscle spasm due to traumatic brain injury. Her blood pressure was 135-174/73-90 mm Hg and heart rate was 60-80 beats/min before using the medicine. The dosage of tizanidine was increased to 4 mg thrice daily and, on day 2, her heart rate decreased to 45 beats/min. Tizanidine was stopped. The next day, her blood pressure was 180/100 mm Hg and heart rate was 120 beats/min. Captopril and nifedipine were given to adjust blood pressure and heart rate, but the effect was not good. Tizanidine 2 mg was given. About an hour later, her blood pressure was 124/69 mm Hg and heart rate was 65 beats/min. Twenty days later, tizanidine 2 mg was given again for hypermyotonia of lower extremity. Half an hour later, her blood pressure decreased to 60/40 mm Hg. Metaraminol was given and then the blood pressure returned to normal. Her blood pressure increased to 180/100 mm Hg again on the following day. The blood pressure tended to be stable gradually by concomitant use of amlodipine besylate, irbesartan, captopril and nifedipine.
  • . 2013, 15(3): 179-2.
  • 病例报告
    Zhang Hongmei
    . 2010, 12(3): 219-1.
    A 45yearold man received an IV infusion of cefotaxime sodium 4g in 0.9% sidium chloride 250 mL and Shuanghuanglian injection 40 mL in 5% glucose 250 mL for upper respiratory tract infection. On second day, IV infusions of cefotaxime sodium and Shuanghuanglian injection were given continuously and no adverse reaction developed. When receiving an IV infusion of ribavirin about 50mL, the patients developed pale, chest distress, short of breath with a BP of 40/10 mm Hg. The infusion was stopped immediately. Oxygen inhalation therapy, adrenalin, dexamethasone, dopamine, and calcium gluconate were given. The patient’s symptoms improved. On third day, the patient did not receive ribavirin infusion and he had no adverse reaction again.
  • 中毒救治
    Zheng Wenbo;Ding Zhirong;Li Huangen
    . 2010, 12(6): 424-2.
    A 27yearold woman selfmedicated with 42 tablets of amlodipine 5 mg and, 30 minutes later, developed repeated vomiting accompanied by a BP of 73/41 mm Hg. She was given IV fluid supplement and dopamine via IV pump for maintaining blood pressure. On day 2 of admission, her urine volume decreased to 200 mL within 15 hours, her BUN and SCr were 12.4 mmol/L and 158 μmol/L,respectively. The patient gradually developed chest tightness, short of breath, SpO2 of 92% and facial edema. Ultrasound examination showed massive pleural and abdominal effusions, and she underwent pleural drainage for aspirating effusions and relieving oppressive symptoms in the heart and lungs. On hospital day 3, her ALT and AST levels were 117 U/L and 89 U/L, respectively. On day 5, the patient developed polyuria with a urine volume up to, on average, 4 000 mL a day, and her serum potassium levels decreased from 34 mmol/L to 2.5 mmol/L. She was treated with a potassium supplement. On day 7, her urine volume was normal and her serum potassium level increased to 3.45 mmol/L. Eleven days after hospitalisation,the patient recovered and was discharged.
  • 综述
    . 2006, 8(1): 1-7.
    阿尔茨海默病在老年人中发病率高,已成为老年人的第四大死因。胆碱酯酶抑制剂是目前防治该病使用较多的一类药物。本文对其药理特性、不良反应、药物相互作用及临床使用进行概述,以有助于其在防治阿尔茨海默病中的合理应用。
  • 病例报告
    . 2005, 7(5): 368-368.
  • 病例报告
    . 2000, 2(2): 127-127.
  • 病例报告
    . 2004, 6(3): 186-186.
  • 监测交流
    . 2005, 7(4): 302-303.
  • 安全用药
    . 2006, 8(6): 433-436.
    卡介苗淋巴结炎为卡介苗常见不良反应,通常分为非化脓性和化脓性两类。其诱发因素涉及卡介苗本身的特性、被接种者的免疫状态和年龄以及接种技术。卡介苗淋巴结炎的防治方法包括提高接种技术、局部治疗及全身抗结核治疗。
  • 中药不良反应
    Bao Zhongyinga;Qiu Shuangb;Yuan Xiaodong
    . 2009, 11(6): 447-1.
    A 75yearold man with vertebrobasilar ischemia received an IV infusion of Danhong injection 20 ml in 5% glucose 250 ml. About 1-2 minutes after infusion initiation, the patient developed feverish face with itching, swelling of both eyelids and lips, tightening sensation in the pharyneal region, dyspnea, palpitation, and cold sweat. An examination revealed a heart rate of 136 beats/min and a BP of 50/30 mm Hg. Danhong injection was stopped immediately, and oxygen inhalation, adrenaline, dopamine, and dexamethasone were given. Twelve hours later, his vital signs became stable, and he was discharged without discomfort.
  • 病例报告
    Fan Chunlei;Zhang Xin;Ding Huiguo
    . 2008, 10(4): 0-0.
    A 36yearold woman with chronic hepatitis C was administered with peginterferon α-2b 80 μg once weekly by subcutaneous injection. The woman developed flu-like symptoms and leukopenia during treatment. Subsequently the dosage of peginterferon α-2b was decreased to 50 μg by subcutaneous injection once weekly. Her symptoms improved after decreasing the dosage of interferon. After 3 months of administration, she presented with persistent hypopotassaemia. Her renal function and urine routine tests were normal; her thyroid function examination showed the following values: T3 0.53 ng/ml, T4 3.35 μg/dl, FT3 0.55 pg/ml, FT4 0.00 ng/dl, TSH >100.0 μU/ml. The patient was diagnosed with hypothyroidism. Peginterferon α-2b was stopped. Thyroxin and potassium chloride were given. Her thyroid function and serum potassium returned to normal limits.
  • Du Guantao;Chen Guilin
    Adverse Drug Reactions Journal. 2009, 11(3): 197-2.
    A 67-year-old man with chronic obstructive pulmonary disease and infection received 2 compound methoxyphenamine capsules (each capsule contains aminophylline 25 mg) thrice daily and an IV infusion of enoxacin 0.2 g once daily. After five days of therapy, he developed chest distress, nausea, short of breath, and several times of vomiting. Enoxacin was stopped. Three days later, his serum theophylline concentration was 19.06 μg/ml. Compound methoxyphenamine capsules were continued. His symptoms mentioned above relieved.
  • Su Su, Gao Lingling, Ma Wenyao, Wang Chunguang, Cui Xiaohui, Liu Tong, Yan Suying
    Adverse Drug Reactions Journal. 2022, 24(2): 80-87. https://doi.org/10.3760/cma.j.cn114015-20210917-01001
    Objective To investigate the influence of potentially inappropriate medication (PIM) on emergency treatment or hospitalization events due to heart failure in elderly outpatients. Methods The data of outpatient, emergency patient, and inpatient above 65 years old collected in Beijing Medical Insurance Affairs Management Center database from July 1, 2016 to September 30, 2016 were retrospectively analyzed. PIM in the outpatient western medicine prescription was identified using the 2015 Beers Criteria-. PIM exposure was defined as at least one PIM was prescribed within 3 months and patients were divided into the PIM exposure and non-PIM exposure groups accordingly. Clinical outcome events were defined as experiencing emergency treatment or hospitalization events due to heart failure after ≥14 days of PIM exposure. Clinical characteristics in patients between the 2 groups were compared and the exposure of specific PIM (PIM with the 3 highest use frequency) in the PIM exposure group was described. Influencing factors of clinical outcome events were analyzed using logistic regression analysis. Results A total of 506-214 patients were entered in the study, including 252-604 males (49.90%) and 253-610 females (50.10%), aged from 65 to 105 years with a median age of 74 (68, 80) years. Definition of PIM exposure was met in 192-740 patients (38.07%); clinical outcome events occurred in 249 patients, of which 131 patients (0.03%) received emergency treatment and 118 patients (0.02%) hospitalized due to heart failure. Incidences of emergency treatment and hospitalization due to heart failure in patients of the PIM exposure group were higher than those of the non-PIM exposure group [0.04% (78/192-740) vs. 0.02% (53/313-474), P<0.001; 0.04% (71/192-740) vs. 0.01% (47/313-474), P<0.001]. The 3 PIM that used most frequently were vasodilators, diuretics, and central nervous system drugs. Multivariate analysis showed that PIM exposure and use of vasodilators and central nervous system drugs had no significant effects on the occurrence of emergency treatment and hospitalization events due to heart failure, while age ≥75 years old and use of diuretics had significant effects. Compared with the 65-74 age group, the risk of emergency treatment for heart failure in patients of the 75-84 age group and ≥85 age group increased by 3.00 times (OR=4.00, 95%CI: 2.46-6.51) and 7.14 times (OR=8.14, 95%CI: 4.64-14.29), respectively, and the risk of hospitalization for heart failure increased by 1.33 times (OR=2.33, 95%CI: 1.52-3.57) and 2.59 times (OR=3.59, 95%CI: 2.03-6.36), respectively. Compared with patients without diuretics treatment, patients treated with diuretics had a 1.91-fold increase in the risk of emergency treatment and hospitalization events due to heart failure (OR=2.91, 95%CI: 1.72-4.93) and 1.72-fold increase (OR=2.72, 95%CI: 1.56-4.74), respectively. Conclusions PIM increases the risk of emergency treatment or hospitalization due to heart failure in elderly outpatients, but it is not an independent influencing factor. Age ≥75 years and diuretics use were independent influencing factors of emergency treatment or hospitalization in elderly patients.
  • Wang Shaojun, Li Chao, Liu Caixia, Su Wuyun, Huang Congxiu
    Adverse Drug Reactions Journal. 2024, 26(1): 12-17. https://doi.org/10.3760/cma.j.cn114015-20230912-00678
    Objective To explore the occurrence of immune-related adverse events (irAEs) and the relationship to efficacy of camrelizumab in treatment for patients with non-small cell lung cancer (NSCLC). Methods Clinical data of patients with NSCLC who received camrelizumab in at the Affiliated Hospital of Inner Mongolia Medical University from December 2020 to December 2022 were collected, and the efficacy of camrelizumab and the occurrence of irAEs were retrospectively analyzed. Patients were divided into irAEs group and non-irAEs group according to whether they developed irAEs. The objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS) of the 2 groups were compared. Results A total of 48 patients were entered in the analysis, including 41 males (85.4%) and 7 females (14.6%), with an age of (65.9±7.4) years; the median treatment cycle was 9 (6, 14); the overall ORR was 52.1% (25/48), the DCR was 83.3% (40/48), and the median PFS was 11 months. Among the 48 patients, 34 patients (70.8%) had 59 times of irAEs, of which 8 patients (16.7%) had at least one irAE of grade ≥3. The median time of irAEs occurrence was 5 (3, 7) treatment cycles. The irAEs with an incidence of >10% included reactive cutaneous capillary endothelial proliferation (RCCEP), thyroid injury, skin injury, lung injury, liver injury, and blood toxicity, with the incidences of 37.5% (18/48), 18.8 (9/48), 16.7% (8/48), 12.5% (6/48), 10.4% (5/48), and 10.4% (5/48), respectively. Compared with non-irAEs group, patients in the irAEs group had higher ORR and DCR [64.7% (22/34) vs. 3/14, 91.2% (31/34) vs. 9/14] and longer median PFS (12.0 months vs. 7.0 months, hazard ratio=0.418, 95% confidence interval: 0.193-0.905), and the differences were statistically significant (all P<0.05). Conclusions The common irAEs of camrelizumab in treatment for patients with NSCLC was RCCEP, and fewer serious irAEs occurs. To a certain extent, patients who experience irAEs during camrelizumab treatment may predict a more pronounced therapeutic response.
  • Zheng Feilang, Zhang Lin, Wang Yiran, Wang Shuai, Wang Ke, Liu Ping
    Adverse Drug Reactions Journal. 2024, 26(1): 44-49. https://doi.org/10.3760/cma.j.cn114015-20231107-00780
    Objective To explore the occurrence and clinical characteristics of thyroid dysfunction caused by sintilimab. Methods The subjects were selected from malignant tumor patients who were treated with sintilimab during hospitalization in the Oncology Department in Heping Hospital Affiliated to Changzhi Medical College from July 1, 2021 to June 30, 2023. Electronic medical records of patients meeting the inclusion criteria were collected; the general conditions, sintilimab application, combined medication, and the thyroid function test results before and after sintilimab application were recorded. For patients with thyroid dysfunction, the causal analysis between sintilimab application and the dysfunction was conducted using Naranjo′s causality assessment scale. The clinical characteristics of sintilimab-related thyroid dysfunction were analyzed based on the medical records that had evaluation results of "certainly" or "probably". Results A total of 145 patients were included in the analysis, and 24 (16.6%) had sintilimab-related thyroid dysfunction, with the causality assessment results "probably". Among the 24 patients, 14 were male and 10 were female, aged 37-87 years; 5 were treated with sintilimab monotherapy, 16 were with combination of chemotherapy drugs, and 3 were with combination of targeted drugs. All 24 patients had baseline thyroid function test results, of which 23-had normal thyroid function and 1 had subclinical hyperthyroidism. Twenty-four patients with thyroid dysfunction included 13-hypothyroidisms, 5 subclinical hypothyroidisms, 2 hyperthyroidisms, and 4 subclinical hyperthyroidisms; 11 occurred within 3 treatment cycles; the severity was grade 1 or 2, without obvious clinical symptoms, except that 4 hypothyroidism patients had mild fatigue. The 13-hypothyroidism patients were treated with levothyroxine sodium tablets (levothyroxine), 9 patients recovered or were improved, and 4 patients were with persistent but not worsening condition. Three of the 5 subclinical hypothyroidism patients were treated with levothyroxine, 2 patients recovered and 1 developed subclinical hyperthyroidism later; the remaining 2 patients were given intensive monitoring without medication intervention, and they developed hypothyroidism later, which recovered after treatment with levothyroxine. None of the 6 patients with hyperthyroidism or subclinical hyperthyroidism received any intervention. Of them, 1 patient with subclinical hyperthyroidism was self-healed and 5 patients developed hypothyroidism or subclinical hypothyroidism later. After giving levothyroxine, 3 patients recovered or were improved  and 2 had persistent but not worsening condition. Conclusions Thyroid dysfunction is the most common immune-related adverse events of sintilimab, mainly hypothyroidism. The clinical symptoms are not obvious, and the severity is mostly grade 1 or 2. When using sintilimab, the thyroid function of patients should be routinely monitored. When hypothyroidism occurs, timely supplementation of levothyroxine is recommended, and the prognosis is generally good.
  • Zhao Na, Ye Xia, Wang Zhiyan, Lu Chao, Hu Fangyuan, Yuan Lei
    Adverse Drug Reactions Journal. 2023, 25(8): 454-459. https://doi.org/10.3760/cma.j.cn114015-20221226-01168
    Objective To explore the neurological adverse events (AE) associated to brexucabtagene autoleucel (brexu-cel) and their risk of occurrence. Methods Neurological AE reports related to brexu-cel were collected through the US FDA Adverse Event Reporting System database from July 1, 2020 to September 31, 2022. The AEs were classified and counted according to the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities (MedDRA) 24.1. The information component (IC) method and the reporting odds ratio (ROR) method were used to perform signal mining. AEs with ≥3 reports and a lower limit of 95% confidence interval (CI) for IC>0 or that for ROR>1 were defined as positive risk signals. The proportion of patients who suffered fatal outcomes after experiencing neurological AEs related to brexu-cel was analyzed. Results A total of 1-960 neurological AE reports related to brexu-cel were collected, involving 559 patients and 22 PTs. Fifteen positive signals (PT) were detected by using the IC and ROR methods. The top 5 PTs in the number of AE reports were immune effector cell-associated neurotoxicity syndrome (153 reports), altered mental status (32 reports), encephalopathy (29 reports), tremor (27 reports), and aphasia (25 reports); the top 5 PTs with the high signal intensity were immune effector cell-associated neurotoxicity syndrome (IC=7.81, ROR=235.74), encephalopathy (IC=4.74, ROR=26.96), aphasia (IC=4.28, ROR=19.58), cerebral edema (IC=3.35, ROR=10.24), and incontinence (IC=3.04, ROR=8.22); incontinence (6 cases, IC=3.04, ROR=8.22) was not recorded in the drug instruction. Patients involved in 17 PTs, out of the 22 PTs, had fatal outcomes, and the proportion of deaths from immune effector cell-associated neurotoxi- city syndrome was 18% (28/153). The PTs with a proportion of patient deaths >50% were unresponsive to stimuli (80%, 4/5), brain oedema (75%, 6/8), cerebrovascular accident (67%, 2/3), lethargy (60%, 3/5), and seizure (57%, 4/7). Conclusions Neurological AEs related to brexu-cel are common, of which incontinence is not yet recorded in the drug instruction. The clinical outcomes of some AEs (unrespontive to stimulus, brain oedema, and lethargy) are poor and should be closely monitored.
  • Chen Shuifang, Chen Hui, Chen Xuemei, Lyu Meiling, Shen Jiumei, Ji Fengqing
    Adverse Drug Reactions Journal. 2023, 25(4): 223-228. https://doi.org/10.3760/cma.j.cn114015-20220622-00553
    Objective To investigate the protective effect of reduced glutathione (GSH) on diclo- fenac-induced acute kidney injury (AKI) in rats and its mechanism. Methods Thirty-three male 8-week-old specified pathogen-free SD rats were randomly divided into control, model, and GSH groups (11 rats in each group) according to a random number table method. Diclofenac sodium solution (200-mg/kg) was intragastrically administered to rats in the model group and GSH group to establish the AKI model. Thirty minutes later, rats in the GSH group were treated with intragastric administration of GSH solution (500-mg/kg), while rats in the control and model groups were with 0.9% sodium chloride injection of equal volume. After 24-hours of administration, blood sample was collected and kidneys were isolated. Kidney function [blood urea nitrogen (BUN), serum creatinine (Scr)], kidney histopathology, and serum and kidney tissue oxidative stress indicators such as malondialdehyde (MDA), superoxide dismutase (SOD), and the inflammatory cytokines such as tumor necrosis factor (TNF)-α and interleukin 6 (IL-6) were examined. The results of each examination results among rats of the 3 groups were compared. Results The BUN and Scr in rats of the model group were significantly higher than those in the control and GSH groups[BUN: (14.34±8.47) mmol/L vs. (7.89±2.20) and (8.46±3.58) mmol/L; Scr: (34.44±6.56) μmol/L vs. (24.77±9.50) and (29.28±4.33) μmol/L, all P<0.05]. Glomerular and tubular morphological changes were observed in both model and GSH rats, but the change in rats of GSH group was less severe than that of the model group. The mean levels of MDA, TNF-α, and IL-6 in both serum and kidney tissue in rats of GSH group were significantly lower than those of the model group[MDA: (9.5±0.2) nmol/ml vs. (10.2±0.6) nmol/ml, (3.6±0.3) nmol/ml vs. (4.0±0.2) nmol/ml; TNF-α: (2.9±2.5) pg/ml vs. (5.4±3.0) pg/ml, (420.9±40.3) pg/ml vs. (470.4±31.3) pg/ml; IL-6: (92.1±34.4) pg/ml vs. (123.9±16.6) pg/ml, (7-547±604) pg/ml vs. (8-047±470) pg/ml, all P<0.05], while the activity of SOD was significantly higher than that in the model group[(102.8±2.8) U/ml vs. (99.7±4.1) U/ml, (387.0±12.7) U/ml vs. (375.9±11.7) U/ml, all P<0.05]. Conclusion GSH has a protective effect on diclofenac-induced acute kidney injury in rats, and its possible mechanism is to inhibit oxidative stress and inflammatory reactions.
  • 病例报告
    Yi Shuzhen;Wang Aili;Yang Zhengwei;Ren Tinglin
    . 2008, 10(2): 137-2.

    A 53yearold man who had received coronary artery bypass graft and ventricular aneurysmectomy was administered with cardiovasculcer drugs, diuretics, and antiinfective drugs. On day 3 after surgery, he developed ventricular tachycardia. The patient was administered with amiodarone 75 mg and subsequent 150 mg intravenously, and then he was infused with a minute dose of amiodarone (600 mg mixed with 50 ml of sodium chloride 0.9%) in the rate of 3 ml/h via infusion pump. On day 4~6 and on day 7 after surgery, the daily dosages of amiodarone were 864 mg and 108 mg, respectively, and they were given with a minute dose via infusion pump. Before surgery, his ALT and TBil levels were 23 U/L and 16 μmol/L, respectively. On day 7 after surgery, his ALT, AST, and TBil levels were 364 U/L, 325 U/L, and 35.8 μmol/L, respectively. On day 9 after surgery, his ALT, AST, and TBil levels were 2 667 U/L, 2 418 U/L, and 53.9 μmol/L, respectively. Amiodarone was discontinued and other medications were continued. The patient was given liverprotective treatment. His ALT, AST, and TBil levels decreased to 24 U/L, 20 U/L, and 187 μmol/L, respectively.

  • 病例报告
    Wang Huaguanga;Pei Yanxiangb
    . 2008, 10(2): 85-2.

    A 54yearold woman with duodenal bulb ulcer took esomeprazole 20 mg once daily, gefarnate 50 mg thrice daily, and hydrotalcite 500 mg thrice daily. Nearly half a month later, she developed anorexia and dark urine gradually. After another one month, she developed yellowish of sclera and pruritus. At out-patient department, her liver function examination showed the following values: AST 890 U/L, ALT 1 123 U/L, ALP 204 U/L, γ-GT 277 U/L, TBil 169.7 μmol/L, DBil 99.7 μmol/L, IBil 70.0 μmol/L,TBA 234.6 μmol/L. Esomeprazole was discontinued after admission, and the patient was treated with reduced glutathione and tiopronin. One week later, the patients yellowish of sclera resolved gradually and urine color returned to normal. On reexamination 3 weeks later, her liver function markedly improved, and then she was discharged from the hospital.

  • 中药不良反应
    Cheng Sheng
    . 2009, 11(1): 69-2.
    A 34yearold woman with chronic pelvic inflammation took 4 Jingangteng 0.5 g capsules thrice daily and Danefukang paste 10 g twice daily. The woman had no previous history of drug allergy and chronic liver disease. After 17 days of treatment, she developed yellowish skin and sclera, nausea, vomiting, abdominal distention, and anorexia. Her liver function tests showed the following values: ALT 828 U/L, AST 768 U/L, TBil 222.1 μmol/L, DBil 100.8 μmol/L, and TBA 283.0 μmol/L. Her jaundice persisted after admission. Her total bilirubin level peaked at 273.4 μmol/L. Her PTA and INR levels were 45.6% and 1.63, respectively. A liver biopsy revealed patchy necrosis in hepatic lobules, severe piecemeal necrosis and bridging necrosis in portal areas. Druginduced severe hepatitis was diagnosed. The two medications were stopped. The patient was given liverprotective and supportive treatment, and plasmapheresis therapy. After 12 weeks of hospitalization, her laboratory testing revealed the following: ALT 49 U/L, AST 47 U/L, TBil 52.0μmol/L, DBil 44.3μmol/L, and TBA 37.9μmol/L. Three months after discharge, her liver function returned to within normal range.
  • 病例报告
    . 2004, 6(6): 365-365.
  • 调查研究
    . 2001, 3(1): 10-17.
    背景:PPA(phenylpropanolamine,苯丙醇胺)常见于食欲抑制药和咳嗽感冒药中,以往病例报告表明含PPA的药物与出血性中风有关,通常发生在首次使用后。为阐明二者相关性,我们设计了一项病例对照研究。方法:18~49岁的男、女性研究病例来自美国43所医院,其合格标准包括在参与项目前30天内发生蛛网膜下腔出血或颅内出血,而既往并无确诊的脑损伤史。采用随机电话拨号,为每个病例安排2例对照进行面访。结果:调查人群包括702名病例和1376名对照。女性服用含PPA食欲抑制药和出血性中风危险之间相关联的调整比值比为16.58(95%可信区间1.51~182.21,P=0.02);女性首次服用含PPA药物与出血性中风危险之间关联的调整比值比3.13(95%可信区间0.86~11.46,P=0.08),所有首次服用的PPA皆为咳嗽感冒药。男、女性调查人群服用含PPA药物与出血性中风危险二者关联的调整比值比为1.49(95%可信区间0.84~2.64.P=0.17);男、女性调查人群服用含PPA的咳嗽感冒药与出血性中风危险二者关联的调整比值比为1.23(95%可信区间0.68~2.24,P...更多=0.49),服用舍PPA的食欲抑制药与出血性中风危险关联的调整比值比为15.92(95%可信区间1.38~184.13,p=0.03)。对男性的分析结果表明:服用含PPA的咳嗽感冒药未引起出血性中风危险增加,男性无一例使用食欲抑制药。结论:结果显示食欲抑制药中的PPA(咳嗽感冒药中的PPA也有可能)是女性出血性中风的一个独立的危险因素。
  • 安全用药
    . 2002, 4(3): 162-162.
    本文介绍应用顺铂加金葡液胸腔注射治疗胸水取得了较好效果,但用药1~3个月可引起患者用药侧胸廓有不同程度的缩窄,对其原因进行了探讨。
  • 不良事件
    . 2006, 8(1): 64-64.
  • 病例报告
    . 2000, 2(3): 186-186.
  • 安全用药
    Cai Haodonga;Liu Minb
    . 2010, 12(6): 401-5.
    Antiviral therapy is generally accepted as an important therapeutic measure for hepatitis B. But there are much controversies over the safety of antihepatitis B virus (HBV) nucleoside (nucleotide) analogues used in pregnant and breastfeeding women. This article reviews the recent medical literatures regarding antiHBV nucleoside (nucleotide) analogues used in pregnant and breastfeeding women in order to provide evidences of antiviral therapy in treating HBVinfected pregnant and breastfeeding women and preventing mothertoinfant HBV vertical transmission.
  • LING Mei;WU Qian-Hu
    . 2013, 15(5): 254-4.
    ObjectiveTo explore the clinical characteristics and risk factors of hepatic veno-occlusive disease (HVOD) induced by senecio chrysanthemoides and provide reference for its rational drug use in clinical practice.MethodsThe CHKD database and Wanfang medicine database were searched using “senecio chrysanthemoides”, “herba gynurae segeti”, and “hepatic veno-occlusive disease” as key words and literature related to HVOD induced by senecio chrysanthemoides were collected and analyzed.ResultsA total of 81 patients with HVOD induced by senecio chrysanthemoides were selected. Of them, 50 were males (61.7%) and 31 females (38.3%) aged from 17 to 81 and with an average of (51±1) years. There were 73 patients (90.1%) aged ≥45 years. Of the 81 patients, 60 patients′primary diseases were orthopedic problems and 11 patients had chronic hepatic diseases. All patients took the drugs by themselves. The time of onset was 1 week to 2 years after taking the drugs. The higher the daily dose was, the earlier the time of onset was; if daily dose was low but medication time was long, the time of onset was late relatively. Thirty-six patients had chronic onset and 45 were subacute onset. The main clinical manifestations were gastrointestinal symptoms and water-sodium retention. Laboratory examination showed abnormal coagulation function and liver function. Liver biopsies in 46 patients showed endothelial damage and luminal stenosis in veins of the hepatic lobule. After the drugs withdrawal and supportive treatments, 14 patients were cured, 32 were improved, and 15 died. Twenty patients′ treatments were given up and their outcomes were unknown. ConclusionsHVOD induced by senecio chrysanthemoides is related to dosage and the mortality is high. Prevention is more important for HVOD induced by senecio chrysanthemoides. Education should be enhanced and the correct methods of taking herbal medicines should be taught.
  • QU Cai-hong;XIE Xiao-yuan;XIAO Pei-yu
    . 2013, 15(5): 286-2.
    A 22-year-old female patient who was newly diagnosed with adult-onset Still′s disease received an oral nimesulide 100 mg twice daily because her arthralgia and fever were not improved after one week of treatments with anti-inflammatory drug methylprednisolone as well as liver and stomach-protective treatments. Before the nimesulide administration, the patient′s aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels were 60 U/L and 50 U/L, respectively and her renal function was normal. After 9 days of nimesulide treatment, her AST and ALT levels were 458 U/L and 450 U/L, respectively. Drug-induced liver injury associated with nimesulide was suspected. Nimesulide was stopped and liver-protective treatments were given. Eleven days later, her AST and ALT levels were 221 U/L and 97 U/L, respectively. Because of the patient′s condition, nimesulide was given again. On the 4th day, she developed dysuria and her levels of serum urea nitrogen, serum creatinine, and uric acid were 11.2 mmol/L, 109 μmol/L, and 435 μmol/L, respectively. On the 5th day of administration, her AST and ALT levels were 542 U/L and 104 U/L, respectively. Drug-induced liver injury as well as renal injury associated with nimesulide was considered. Nimesulide was stopped. Four days later, her renal function returned to normal and 2 weeks later, her AST and ALT levels returned to 47 U/L and 32 U/L, respectively.
  • 病例报告
    . 2007, 9(2): 94-94.
  • Wang Yonga;Liu Haiyanb;Xie Jianzhongb
    Adverse Drug Reactions Journal. 2010, 12(2): 90-2.
    Three patients( 1man and 2 women aged 1845 years ) received an IV infusion of Lianbizhi injection 0.5 g in 5% glucose injection 250ml once daily. On days 2 or 3 of therapy, lumbago appeared. Renal function tests revealed the following values: BUN 9.6~15.3 mmol/L, SCr 233.0~550.0 μmol/L, blood uric acid 553.0~722.0 μmol/L. Lianbizhi injection was withdrawn immediately and symptomatic and supportive treatments were given. Their symptoms subsided and renal functions returned to within normal range.
  • Huang Jinzhu, Luo Xiao, Li Yong, Li Xin, Wang Ziqi, Tong Chunxiang, Zhao Zhenman, Lu Laichun
    . 2015, 17(4): 268.
    ObjectiveTo evaluate the effectiveness and safety of posaconazole in antifungal prophylaxis.MethodsCNKI, VIP, CBM, Wangfang Database, PubMed, Cochrane Library, Embase, OVID, and Web of Science from the inception to March 2014 were searched. The randomized controlled trials (RCT) which compared posaconazole with placebo or other antifungal drugs in antifungal prophylaxis and the endpoint was the incidences of invasive fungal infection (IFI), all-cause mortality, or adverse reactions were collected. The related information was selected and RevMan 5.1 software of Cochrane Collaboration was used for statistical analysis. The results were expressed as odds ratios (OR) and its corresponding 95% confidence intervals (CI).ResultsA total of 6 RCTs were enrolled into the study. Of them, 4 RCTs were comparison of posaconazole with one other antifungal drug, and 2 RCTs were comparison of posaconazole with two kinds of other antifungal drugs. There were 1 410 cases in the experimental group and 929 cases in the control group. The results of Meta-analysis showed that the incidence of IFI in the experimental group was lower than that in the control group (OR=0.37, 95%CI: 0.27-0.50, P<0.000 01). The results of comparison of posaconazole with other antifungal drugs showed that the incidence of invasive fungal infections in the experimental group were lower than those in the fluconazol group (OR=0.42, 95% CI: 0.28-0.64, P<0.000 1) and the itraconazole group (OR=0.33, 95% CI: 0.21-0.53,P<0.000 01). There were no statistical significant differences in incidence of invasive fungal infections between the experimental group and the control groups of voriconazole and amphotericin B (OR=0.13, 95% CI: 0.01-2.67, P=0.19; OR=0.11, 95% CI: 0.01-2.34, P=0.16). The incidence of invasive mold infection in the experimental group was lower than that in the fluconazole group (OR=0.25, 95% CI: 0.12-0.51, P=0.000 1) . There was no statistical significant difference in incidence of invasive mold infection between the experimental group and the itraconazole group (OR=0.10, 95% CI: 0.01-1.59, P=0.10). There were no statistical significant differences in incidence of invasive candida infection between the experimental group and the control groups of fluconazol and itraconazole (P=0.91, P=0.33). The all-cause mortality in the experimental group was lower than that in the control group (OR=0.64, 95% CI: 0.49-0.82, P=0.000 5). The incidence of adverse reactions in the experimental group was lower than that in the control group (OR=0.81, 95% CI: 0.66-0.99, P=0.04); but the result of subgroup analysis showed that there were no statistical significant difference in the incidence of adverse reactions between the experimental group and the control groups such as fluconazol, itraconazole, voriconazole, and amphotericin B liposomes (all P>0.05). It was considered that publication bias existed in above-mentioned 6 RCTs. ConclusionThe effectiveness of posaconazole in antifungal prophylaxis is better than those in the non-posaconazole drugs and the safety of posaconazole is similar to the non-posaconazole drugs.
  • 会议纪要
    . 2014, 16(1): 57-1.
  • Zhang Lixin;Fan Rong;Ren Tianshu;Ren Liuli;Dang Dasheng;Shi Guobing
    . 2015, 17(1): 11-4.
    ObjectiveTo explore the short-term efficacy and safety of the proton pump inhibitor (PPI) pantoprazole sodium versus rabeprazole sodium for preventing gastrointestinal hemorrhage after percutaneous coronary intervention (PCI) which used aspirin and clopidogrel dual antiplatelet therapy.MethodsThe clinical data of patients who were hospitalized in the General Hospital of Shenyang Military Command during February to April 2014 and were diagnosed as coronary heart disease (CHD) and received PCI were collected and analyzed retrospectively. The patients were divided into pantoprazole group (an IV infusion of pantoprazole sodium 40 mg in 0.9% 100 ml sodium chloride, once daily) and rabeprazole group (oral rabeprazole sodium 10 mg once daily). Three days before PCI, the two groups received dual antiplatelet therapy with clopidogrel and aspirin. The occurrence of gastrointestinal hemorrhage and major cardiovascular events and incidence of adverse reactions within two months after PCI were compared.ResultsA total of 84 patients were enrolled in this study, each group had 42 cases. Pantoprazole sodium group comprised 23 males and 19 females with an average age of (65±8) years; rabeprazole sodium group comprised 22 males and 20 females with an average age of (66±8) years. During follow-up, none of the two groups of patients developed gastrointestinal hemorrhage, no cardiovascular events including myocardial infarction, recurrent angina, stent thrombosis, revascularization occurred. The incidence of gastrointestinal reaction in the pantoprazole sodium group and rabeprazole sodium group were 9.5%(4/42) and 11.9%(5/42), respectively. The results of liver function, kidney function and blood routine tests were within normal range in two groups before and after treatment. Before treatment, pantoprazole sodium group serum aspartate aminotransferase [(47±28)U/L] was higher than that of rabeprazole sodium group [(24±13)U/L], the difference was significant (P=0.020). After treatment, pantoprazole sodium group serum aspartate amino-transferase (28±15) U/L was significantly lower than that before treatment (P=0.026).ConclusionsIn patients underwent PCI and dual antiplatelet therapy, combined treatment with pantoprazole sodium or rabeprazole sodium may be effective in preventing gastrointestinal hemorrhage and do not increase the risk of cardiovascular events within short time. There was no significant difference in efficacy and safety for preventing gastrointestinal hemorrhage in short-term between intravenous pantoprazole sodium and oral rabeprazole sodium.
  • 中药不良反应
    Lin Fang;Li Ke
    . 2014, 16(5): 319-2.
    A 25-year-old female patient with eczema and nettle-rash received 4 Runzaozhiyang capsules (润燥止痒胶囊) thrice daily followed the doctor′s advice. She developed fatigue, jaundiced skin and sclera, poor appetite, and dark urine about one month after drug administration. Laboratory tests revealed the following results: alanine aminotransferase 2 211 U/L, aspartate aminotransferase 3 977 U/L, total bilirubin 299.0 μmol/L and direct bilirubin 157.2 μmol/L. The diagnosis on admission was drug-induced acute liver failure. The patient was given liver protecting agents and jaundice relieving therapy. On day 6 of admission, the patient developed fever, vomiting, and abdominal distension. The testing of ascites revealed the following results: total cell count 2 110×106/L, leucocyte count 1 200×106/L, neutrophilic granulocyte 0.80. She was diagnosed as primary peritonitis and treated with anti-bacterial therapy. On day 7 of admission, the patient developed dysphoria and slow in response. The blood ammonia was 107 μmol/L. She was diagnosed as hepatic encephalopathy and treated with blood ammonia-reducing medicine. On day 9 of admission, the patient developed lethargy and dyspnea and treated with tracheal intubation. On day 10 of admission, the patient lost consciousness, had no response to orbital pressing, bilateral mydriasis, and dullness of light reflex. On day 11 of admission, she developed high fever and declined blood pressure. The blood ammonia was 306 μmol/L. She was diagnosed as hepatic encephalopathy (stage IV) and treated with drugs, enema, and continuous hemofiltration. On day 12 of admission, the patient died due to septic shock caused by abdominal infection.
  • 病例报告
    Zhou Hong;Yu Xiaojia;Liu Lihong
    . 2014, 16(6): 374-2.
    A 75-year-old female patient received treatments with cefoxitin, dyphylline, acetylcy-steine, and torasemide for interstitial pneumonia accompanied with infection. Before treatments, the laboratory test results were as follows: peripheral white blood cell count 9.8×109/L, neutrophile granulocyte 0.76, albumin 27.6 g/L, urea nitrogen 7.99 mmol/L, creatinine 130 μmol/L, uric acid 388 μmol/L. On hospital day 6, she received an IV infusion of cefepime 2 g twice daily instead of cefoxitin because of poor treatment effect. Other therapies were the same as before. On hospital day 9, the patient developed mania and no special treatment was given. On hospital day 10, she developed restlessness, paraphasia, and delirium. Cefepime, dyphylline, and acetylcysteine were discontinued at the same day and IM injection of diazepam 5 mg twice daily was given. On hospital day 12, the mental symptoms disappeared, dyphylline and acetylcysteine treatments were given again. The mental symptoms did not recur.
  • Fu Dong*, Liu Min, Yi Wei, Hu Yuhong, Cai Haodong
    . 2015, 17(4): 253.
    ObjectiveTo explore the safety and effectiveness of tenofovir disoproxil in patients with chronic hepatitis B during pregnancy.MethodsThe female patients with chronic hepatitis B in Beijing Ditan Hospital, Capital Medical University from January 1, 2011 to May 24, 2013, taking tenofovir disoproxil before pregnancy or during the first trimester of pregnancy (0-12 weeks of gestation) at least until delivery, were enrolled in the study. The efficacy of tenofovir disoproxil, adverse events during pregnancy and perinatal period, fetal growth and birth conditions, and the growth and development of newborns were observed. The active and passive immunization with hepatitis B vaccine 10 μg (0-1-6 regimen) and hepatitis B immune globulin (100-200 U) were administered to the newborns.ResultsForty-eight cases of pregnant women, of whom 3 cases (6.2%) had spontaneous abortion in early pregnancy; one case had spontaneous abortion and became pregnant again, were eligible for inclusion and 46 of the pregnant women were eventually enrolled into the study. Neither adverse events associated with tenofovir disoproxil nor abnormal laboratory test results and liver disease progression or DNA HBV rebound were found in any of the 46 pregnant women. The 46 pregnant women delivered 47 newborns, fetal tenofovir disoproxil exposure time was 31 to 41 weeks, in average (37.6+3.0) weeks, no fetal growth restriction or developmental delay were found in pregnancy monitoring. None of the 47 newborns had any abnormality at birth, and the results of screening for hearing, phenylketonuria and congenital hypothyroidism were all negative. The blocking of HBV mother-to-child transmission was successful. During the follow-up of 1-4 years after birth, except for 2 cases of hereditary diseases, no birth defects, organ damage or abnormal development associated with tenofovir disoproxil were found. Conclusion Tenofovir disoproxil is relatively safe for the mother and fetus during pregnancy with chronic hepatitis B, and its antiviral effect is reliable.
  • . 2016, 18(1): 76.
  • Ma Yanli, Zhao Jing
    . 2017, 19(2): 140-141.
    A 30-year-old woman was hospitalized because of ectopic pregnancy. She received an intramuscular injection of methotrexate 75 mg and mifepristone tablets 300 mg taking orally in three days. On day 5, the patient developed fever and oral ulcers. On day 7, red rashes appeared on her face and limbs. Laboratory tests showed the following results: C-reactive protein (CRP) 105.3 mg /L, procalcitonin 0.33 μg/L, white blood cell (WBC) 2.5×109/L, neutrophil count 0.85, red blood cell (RBC) 3.3×1012/L, platelet count (PLT) 244×109/L, hemoglobin (Hb)103 g/L. On the 8th day, abdominal pain and diarrhea appeared, her values of WBC, neutrophils, RBC, PLT, and Hb were 0.7×109/L, 0.31, 3.4×1012/L, 202×109/L, 105 g/L. She was diagnosed as myelosuppression due to methotrexate. She received an IV infusion of methylprednisolone 80 mg once daily, subcutaneous injection of recombinant human granulocyte colony stimulating factor 300 μg, and the symptomatic supportive treatments included anti-infection, volume expansion, and intravenous nutrition. However, the patient′s condition did not improve obviously. On day 10, the erythema widely distributed throughout her body. Laboratory tests showed WBC 0.2×109/L, neutrophil count 0.14, RBC 2.7×1012/L, PLT 62×109/L, Hb 84 g/L. On day 11, the patient was transferred to another hospital for treatment. It was told by follow-up that the patient died from respiratory and circulatory failure on the third day after transfer.
  • 病例报告
    . 1999, 1(3): 188-188.
  • 病例报告
    . 2007, 9(1): 49-49.
  • LIU He-ping;WU Xin-rong;YUAN Jin
    . 2013, 15(5): 298-3.
    A 20-year-old woman took herbal medicine Polygonum multiflorum powder 15 g/d by herself for blacking hair. Two weeks later, the patient presented with poor appetite and fatigue and, three weeks later, she experienced yellowish urine and liver function tests showed the following values: aspartate transaminase (AST) 878 U/L, alanine aminotransferase (ALT) 1121 U/L, total bilirubin (TBil) 100.8 μmol/L, direct bilirubin (DBil) 77.4 μmol/L. On day 42 of using Polygonum multiflorum powder, laboratory test revealed the following levels: AST 472 U/L,ALT 755 U/L,TBil 102.9 μmol/L,DBil 76.7 μmol/L, WBC count 3.2×109/L, neutrophil count 0.27×109/L. Liver damage and agranulocytosis were considered to be probably produced by the medicine. Polygonum multiflorum was withdrawn and liver-protective medications were used to treat jaundice, and other comprehensive therapy were given. Ten days after treatment, laboratory test revealed the following levels: ALT 62 U/L, AST 73 U/L, DBil 20.5 μmol/L, TBil 30.2 μmol/L, WBC count 6.2×109/L, neutrophil count 3.60×109/L.
  • 中药不良反应
    ZHOU Yan-ping;SUN Li-jian;YU Shan-shan;ZHANG Shi-long;ZHOU Xu
    . 2012, 14(5): 327-2.
    A 62-year-old male patient self-medicated with oral senecio chrysanthemoides powder 15 g daily for injury. After half a year, the patient appeared ascites. Senecio chrysanthemoides was stopped. The hepatoprotective treatment was ineffective in the local hospital and he developed severe jaundice and hepatic encephalopathy, and then he was admitted to our hospital. Laboratory examinations showed the followed levels and values: WBC count 13×109/L, total protein 37 g/L, total bilirubin 128.9 μmol/L, direct bilirubin 103.3 μmol/L, alanine aminotransferase 104 U/L, serum creatinine 298 μmol/L, blood urea nitrogen 38.1 mmol/L, uric acid 975 μmol/L, prothrombin time 31.7 seconds, prothrombin activity 26%, C-reactive protein 16 mg/L, creatine kinase 383 U/L. Drug-induced hepatic veno-occlusive disease was diagnosed. Despite treatment with liver-protective drugs, medications used to treat jaundice, anti-infective drugs, diuretics, and nutritional support, patient progressed to multiple organ failure and eventually died.
  • 病例报告
    WEN Li;YU Yi-chun;ZHOU Hao;WEN Wei;ZHANG Xin-chao
    . 2012, 14(2): 120-3.
    An 88-year-old male presented to hospital with acute exacerbation of atrial fibrillation. He had a history of bronchial asthma, but there was no signs of asthma attack on admission. The patient was given an IV bolus of amiodarone 150 mg in 5% glucose 10 ml at a rate of 1 ml/min. About 6 minutes after the injection was started (amiodarone about 90 mg), the patient suddenly experienced respiratory arrest, generalised cyanosis, unconsciousness, no breath sound around bilateral pulmonary lobes. Amiodarone was withdrawn immediately. He received assisted ventilation and oxygen inhalation therapy. After 2 minutes of respiratory arrest, his consciousness and breath gradually recovered. But he presented with marked expiratory dyspnea and widespread wheeze over both lung fields. Then methylprednisolone and doxofylline were added to his regimen. Eight minutes later, he became conscious gradually and pulmonary wheeze vanished. At the same time, the ventricular rate was stable around 70-80 beats/min. Twenty-five minutes later, shortness of breath and palpitation subsided.
  • 中药不良反应
    Luo Xiao;Cheng Sheng
    . 2010, 12(3): 223-2.
    A 51yearold woman received Sanjiuweitai for chronic atrophic gastritis. Three months later, the patient developed icteric sclera and dark urine. Laboratory tests revealed the following levels and values: ALT 215 U/L, AST 158 U/L, ALP 134 U/L, γ-GT 129 U/L, TP 69.5g/L, ALB 33.5 g/L, TBil 139.2 μmol/L, DBil 71.0 μmol/L, IBil 68. 2 μmol/L. Viral hepatitis was excluded. Liver biospy revealed hepatocellular swelling and necrosis. Druginduced liver damage was diagnosed. Sanjiuweitai was discontinued and liverprotective treatment were given. One month later, her hepatic function returned to normal.
  • 中药不良反应
    Jiao Lin
    . 2011, 13(2): 131-2.
    A 46yearold woman selfmedicated with 2 pills (6 g) of Kudan thrice daily for her psoriatic arthritis. After 5 days, the patient developed fatigue and abdominal distension.She continued taking the drug, and her symptoms worsened. Nineteen days later, Kudan pills were stopped. On day 2 after drug discontinuation, she had markedly jaundiced skin and sclera, and then she was hospitalized. Biochemical tests revealed the following values: ALT 1384 U/L, AST 1311 U/L, TBil 91.4 μmol/L, DBil 53.5 μmol/L, IBil 37.9 μmol /L. Druginduced live damage was diagnosed and she received glycyrrhizin diammonium, reduced glutathione and other treatment. Twenty days later, her symptoms disappeared and liver function basically returned to normal, and then she was discharged.
  • 论著
    Xie Lijing;Zhang Lixia;Zhou Jing;Sun Chengye
    . 2011, 13(3): 161-4.
    Objective: To study the skin irritation and sensitization of Toxicodendron vernicifluum (T.vernicifluum) leaf in animals. Methods: Flesh leaves (free of rachises) of T.vernicifluum were collected, frozen, and ground. Ground T .vernicifluum leaves were prepared into a paste with distilled water at room temperature; the ratio of the leaf to distilled water was 1 to 1. Skin irritation testing was conducted in 6 New Zealand white rabbits. A patch (3 cm×3 cm) of fur of each rabbit was shaved from both sides of its back. The paste 1.0 g was applied to the bare skin on the left side of the back and maintained for 4 hours and then cleaned off. Distilled water 0.5 ml was applied to the bare skin on the right side of the back as control. Skin responses in the part applied with the paste were observed and scored 1, 24, 48 and 72 hours after cleaning. Skin sensitization testing was conducted in 50 albino guinea pigs. These pigs were divided into 3 groups: the experiment group (10 males and 10 females), the positive control group (10 males and 10 females) and the negative control group (5 males and 5 females). A patch (2 cm×2 cm) of fur of each pig was shaved from both sides of its back. On the beginning of experiment and on days 7 and 14 of experiment, the paste 0.8 g, 2.5% 2,4-dinitro-chlorobenzene 0.2 g and distilled water 0.4 ml were applied to the bare skin on the left side of each pig’s back in the experiment, positive control and negative control groups and maintained for 6 hours and then cleaned off, respectively. On days 28 of experiment, the paste 08 g was applied to the bare skin on the left side of each pig’s back in the experiment and negative control groups, 1.0% 2,4-dinitro-chlorobenzene 0.2 g was applied to the bare skin on the left side of each pig’s back in the positive control group and maintained for 6 hours and then cleaned. The rate and severity of sensitization were calculated and assessed 24 and 48 hours after cleaning, respectively. Results: In the skin irritation testing, 3 rabbits developed erythema after applying the paste to their skin. The average irritation score was 0.67 and the irritation severity was mild. In the skin sensitization testing, the guinea pigs in the experiment and negative control groups did not develop erythema and edema 24 and 48 hours after applying the paste to their skin. The average sensitization score was zero, sensitization rate was zero, and sensitization severity was mild. The guinea pigs in the positive control group developed erythema and edema and the average sensitization score was 3.65 and sensitization rate was 100% 48 hours after applying the paste to their skin. The sensitization severity was severe. Conclusion: The skin irritation of T .vernicifluum leaf is mild and there is no skin sensitization in the experimental animals.
  • 病例报告
    . 2005, 7(5): 370-371.
  • 综合报道
    . 2001, 3(2): 110-111.
  • 病例报告
    Mao Wanheng;Shang Qianhui;Jiang Qianfeng
    . 2008, 10(5): 0-0.

    A 63-year-old man had a history of epilepsy and hypertension. In recent 3 years, he has been receiving one tablet of sustainedrelease nifedipine 10 mg twice daily. Enalapril was added to his treatment two months ago due to poorly controlled hypertension. The patient developed gross hematuria with a small amount of blood clots 8 hours after administration of enalapril. Urinalysis showed occult blood (++++). Renal, urethra or bladder stones and tumors were not determined by B-scan ultrasound. Enalapril was stopped. Symptomatic therapy was given and hematuria disappeared. Sustainedrelease nifedipine tablets were continued. Above-mentioned symptoms did not recur.

  • 病例报告
    . 2004, 6(5): 336-336.
  • 中毒救治
    . 2004, 6(4): 251-252.
  • 综合报道
    . 2001, 3(3): 182-184.
  • 监测简报
    . 2003, 5(3): 195-196.
  • Ma Yanli, Zhou Yang, Zhang Donglei, Zhang Lijuan, Ning Meiying, Zhao Jing
    Adverse Drug Reactions Journal. 2022, 24(1): 35-37. https://doi.org/10.3760/cma.j.cn114015-20210223-00212
    A 25-year-old female patient took 4 Rupi Sanjie capsules orally (0.55 g/capsule) thrice daily and Xiangshao granules 1 bag (4 g/bag) orally thrice daily by herself for breast nodule. After 2 months, the patient developed yellow urine, skin itching, and yellowish skin and sclera. Laboratory tests showed alanine aminotransferase (ALT) 1-334-U/L, aspartate aminotransferase (AST) 717-U/L, alkaline phosphatase (ALP) 164-U/L, total bilirubin (TBil) 88-μmol/L, and γ-glutamyltransferase (γ-GT) 127-U/L. Liver injury caused by Rupi Sanjie capsules and Xiangshao granules were considered. The 2 drugs were stopped and the treatments of liver protection and cholagogic were given. Three weeks later, her symptoms above-mentioned disappeared and the laboratory tests showed ALT 106-U/L, AST 88-U/L, ALP 88-U/L, TBil 13-μmol/L, and γ-GT 32-U/L. At 1 month of follow-up, the patient′s liver function returned to normal. The patient′s liver injury might be related to the component of bupleurum in Rupi Sanjie capsules and Xiangshao granules and the component of prunella vulgaris in Rupi Sanjie capsules.
  • Ma Zikun, Guo Tiantian, Wang Yu, Wu Ting, Wang Yan, Li Kexin, Ou Xiaojuan, Jia Jidong, Zhao Xinyan
    Adverse Drug Reactions Journal. 2023, 25(2): 69-75. https://doi.org/10.3760/cma.j.cn114015-20220801-00700
    Objective To investigate the difference in clinical characteristics of drug-induced liver injury (DILI) between patients of different gender. Methods Through the hospital electronic medical record system, clinical data of patients hospitalized because of DILI at Liver Research Center, Beijing Friendship Hospital, Capital Medical University from January 2005 to January 2021 were collected and retrospectively analyzed. The collected information included gender, age, body mass index, underlying diseases, medication, results of the first laboratory tests after admission, clinical manifestation and types of DILI, etc. The patients were divided into 2 groups according to gender and the clinical characteristics of DILI were compared. The factors affecting death/liver transplantation in DILI patients were analyzed by Cox regression method. Results A total of 616 patients with DILI were entered, including 139 males (22.6%) and 477 females (77.4%). The median age was 56 (47, 64) years, ranging from 18 to 80 years. Drugs that caused DILI were traditional Chinese medicine and/or health care products (TCMHCP) in 345 patients (56.0%), western drugs in 148 patients (24.0%), and TCMHCP and western drugs in 123 patients (20.0%). Death/liver transplantation occurred in 42 patients (6.8%), including 3 liver transplantation, 19 death directly caused by the liver disease, and 20 death with causes other than liver disease. The incidences of dark urine and abdominal distension, severe liver injury, and death/liver transplantation in male patients were all higher than those in female patients, respectively [71.9% (100/139) vs. 60.0% (286/477), P=0.010; 28.8% (40/139) vs. 18.7% (89/477), P=0.010; 46.8% (65/139) vs. 40.5% (193/477), P<0.001; 15.1% (21/477) vs. 4.4% (21/139), P<0.001]. Laboratory test results such as the white blood cell count, hemoglobin, total bilirubin, direct bilirubin, total bile acid, triglyceride, and low density lipoprotein cholesterol in male patients were all higher than those in female patients, while the levels of pre-albumin, immunoglobulin G, immunoglobulin M, and serum creatinine were lower (all P<0.05). Cox regression analysis showed that male, older age, low albumin, high total bile acid, high serum creatinine, and prolonged international normalized ratio (INR) were the independent influencing factors of death/liver transplantation in patients with DILI. Conclusions Clinical manifestation are different in DILI patients of different gender hospitalized in the Liver Research Center, Beijing Friendshop Hospital, Capital Medical University. In male patients, cholestasis is more obvious, the disease condition is more serious, and death/liver transplantation is more common. Male patients and patients with older age, lower albumin, higher total bile acid, higher serum creatinine, and higher INR are more prone to death/liver transplantation, which should be paid attention to in clinic.
  • 病例报告
    . 2002, 4(1): 48-49.
  • 病例报告
    Hao Shijun;Xie Zhuomin;Li Yunsheng;Gao Xiafen;Cheng Yongjun;Chen Xiaoli
    . 2008, 10(5): 0-0.

    A 22-year-old man had a 3-year history of nephrotic syndrome. He was treated with prednisolone 40 mg and azathioprine 50 mg twice daily for recurrence of the disease. The patient's routine blood and liver function levels were normal before treatment. Two months after the therapy, his ALT level increased to 110 U/L. Subsequently, the dosage of azathioprine was changed to 50 mg once daily, and the previous dosage of prednisolone was maintained, and he was also given liverprotective treatment, but his abnormal liver function persisted. Three months later, the patient developed hyperpyrexia, headache, mild jaundice, pancytopenia and worsening liver function. His routine blood test showed a WBC count of 1.40×109/L with 96.57% lymphocytes, a RBC count of 1.09×1012/L,a Hb level of 35 g/L,a PLT count of 19.20×109/L. His liver function tests revealed the following values: ALT 386 U/L,AST 303 U/L,GGT 147 U/L,total bilirubin 102 μmol/L,and direct bilirubin 78 μmol/L. Azathioprine was stopped. Antiinfective,liverprotective therapy and blood transfusion were given. Thirty days later, his symptoms improved, his jaundice subsided gradually, his routine blood and liver function levels normalized and he was discharged.

  • 病例报告
    . 2004, 6(3): 185-186.
  • 不良事件
    . 2002, 4(3): 203-203.
  • 中毒救治
    . 2005, 7(5): 353-354.
  • ADE简报
    . 2000, 2(4): 266-266.
  • 中毒救治
    . 2002, 4(2): 111-111.
  • 网络医药
    . 2002, 4(6): 400-403.
  • 病例报告
    Du Jinming;Liu Baoping
    . 2011, 13(3): 192-2.
    A 76-year-old man self-medicated oral colchicine 3 mg/15 h in divided doses for his acute gouty arthritis. The next day, he developed confusion, no response to verbal stimuli, profuse sweating, and no spontaneous activity of his limbs. Laboratory tests showed a blood glucose level of 26 mmol/L, and his liver function, electrolytes and serum creatinine were in normal range. Hypoglycemia was diagnosed. An IV push of 50% glucose 20 ml was given immediately and, about 2 minutes later, he regained consciousness, and then it was changed to an IV infusion 10% glucose 500 ml. One hour later, he gradually returned to normal. The next morning, he redeveloped profuse sweating, confusion accompanied with a blood glucose level of 3.2 mmol/L. After administration of an IV push of 50% glucose 20 ml, the patient improved. He was observed for 4 days, and then he was discharged without discomfort.
  • 病例报告
    Song Yan;Ji Dianzhong;Li Jijun;Zhang Yiyan;Yao Fenghua;He Zongze;Zhao Changzheng
    . 2010, 12(5): 345-2.

    A 60-year-old woman with systemic lupus erythematosus initially received oral methylprednisolone 40 mg/d. After 45 days of methylprednisolone therapy, mycophenolate mofetil 0.75 g was added to her regimen. A further 38 day’s later, the patient developed fever, tight chest, and hypoxemia. A chest Xray showed that the lines in her lungs was increased and blurred, and her lung field was groundglass pattern. Laboratory tests revealed that her CD4+ Tlymphocyte count was 103/mm3, and pneumocystis jirovecii was detected in her brochovesicular lavage solution. The patient was diagnosed with pneumocystis pneumonia. The dosage of mycophenolate mofetil was reduced to 0.5 g twice daily. In addition, caspofungin 50 mg/d and 2 sulfamethoxazole,sulfadiazine and trimethoprim tablets four times daily were given. Five days after drug administration, her tight chest and dyspnea improved.

  • 病例报告
    Yi Shuzhen
    . 2010, 12(6): 433-2.
    A 59 yearold woman with breast cancer received a patch of transdermal fentanyl (8.4 mg) for back and loin pain control. Thirty minutes later, she fall asleep and, about 4 hours later, she became unconscious accompanied with head backwards position, stiffness of neck, tetany, bilateral miosis, a sluggish papillary light reflex, and a slow respiratory rate (6-7 breaths/min); her SpO2 decreased to 0.77. The abovementioned adverse reactions were considered to be related to fentanyl overdose. The patch of transdermal fentanyl was removed immediately. Oxygen inhalation and IV naloxone 0.2 mg were given. Subsequently, the patient’s tetany relieved and her respiratory rate increased to 18 breaths/min. She regained consciousness and there was no abnormality in her sensory and motor functions.
  • SHEN Qun-hong;TANG Li-yang;ZHANG Xiao-le;SHENG Ying

    ObjectiveTo explore the influence of drug safety environment on pharmacists′drug safety practice.MethodsThe subjects of the investigation were 1959 pharmacists (1763 from 3A hospitals and 196 from 2A hospitals), who were selected from 112 hospitals of 26 provincial administrative regions in China using stratified sampling method. Baseline survey questionnaire about patient safety and medication errors was designed by the research group and the survey was performed by filling out an online questionnaire and paper questionnaires. In this questionnaire, 4 dimensions, including drug safety knowledge, attitude, environment, and practice, and 6, 3, 8, and 6 sub-dimensions corresponding to above 4 dimensions were designed. There were 102 questions altogether. Five-point scale was used for each question and higher scores represented good performance. Specified ordinary least squares regression models were used to analyze dataset from this survey.ResultsThe scores of drug safety knowledge, attitude, environment, and practice in 1959 pharmacists were (3.45±0.23), (3.72±0.45), (3.35±0.50), and (3.68±0.48), respectively. The results showed that drug safety knowledge, attitude, and environment had significant positive influences on drug safety practice and among them the influence of drug safety environment was the largest. Among the 8 sub-dimensions of drug safety environment, hospital regulation and drug safety culture of work team had the largest influence on pharmacist′s drug safety practice. The pharmacist′s drug safety knowledge had the largest influence on basic drug safety practice, while drug safety environment had the largest influence on pharmacists′advanced drug safety practice.ConclusionsThe drug safety environment is the most important factor to influence pharmacists′drug safety practice in China. The most effective way to increase the levels of pharmacists′drug safety practice is to improve pharmacists′drug safety knowledge levels and improvement of the drug safety environment is the most effective way to increase the levels of drug safety practice.

  • Liao Qiuju, Zheng Zheng, Zhao Yi, Li Xiaoxia
    . 2015, 17(6): 428-432.
    ObjectiveTo explore the factors related to ovarian injury after cyclophosphamide therapy in the patients with systemic lupus erythematosus (SLE) and Takayasu arteritis (TA).MethodsData of patients with SLE and TA hospitalized in Xuanwu Hospital of Capital Medical University from June 2012 to October 2014 were collected and a retrospective study was conducted. All patients received cyclophosphamide treatment and were followed up in the outpatient setting. The patients with SLE who used cyclophosphamide treatment were divided into SLE group and the patients with TA who used cyclophosphamide treatment were divided into TA group. The overall incidence of ovarian injury, the incidence of amenorrhea and the time after cyclophosphamide treatment and the cumulative dosage which led to ovarian injury and amenorrhea were recorded and compared. ResultsSixty-three patients were enrolled, 46 cases were in SLE group, ages ranged from 15 to 41years; 17 cases were in TA group, ages ranged from 17 to 37 years. Two groups of patients with ovarian injury after cyclophosphamide occurred mainly from 20 to 39 years. The overall incidence of ovarian injury and incidence of amenorrhea in two groups had no statistically significant difference [60.9%(28/46) vs. 35.3%(6/17), 19.6%(9/46) vs. 5.9%(1/17), all P>0.05]. The ovarian injury in SLE group occurred in week 6 after cyclophosphamide treatment, the average time was 13 weeks. In TA group ovarian injury occurred in week 16, the average time was 21 weeks. Ovarian injury occurred earlier in SLE group than that in TA group, the difference was statistically significant (P=0.021). The cumulative dose of cyclophosphamide in SLE group was lower than that the TA group [(7.2±0.8) g vs.(8.0±0.9) g], the difference was statistically significant (P=0.045). The cumulative dose of cyclophosphamide and the age showed a negative correlation (SLE group r=-0.681, P=0.028; TA group r=-0.244, P=0.043).ConclusionsThe cumulative dose of cyclophosphamide in patients with SLE and TA is a risk factor for ovarian injury. The cumulative dose of cyclophosphamide in SLE patients was less than patients with TA. The older patient who use cyclophosphamide initially are at greater risk of ovarian injury.
  • Chen Shuifang, Guo Yaochang
    Adverse Drug Reactions Journal. 2020, 22(12): 697-698. https://doi.org/10.3760/cma.j.cn114015-20200210-00099
    A 40-year-old female patient was treated with sulfasalazine 0.75 g thrice daily for spondyloarthritis. On the 20th day of medication, the patient developed skin rash all over the body, which was gradually aggravated and accompanied by fever, lymphadenectasis, and splenomegaly. Laboratory tests revealed the white blood cell count 14.4×109/L, the eosinophil count 0.82×109/L, the urinary occult blood (+++), alanine aminotransferase 84 U/L, and aspartate aminotransferase 96 U/L. Drug-induced hypersensi- tivity syndrome was diagnosed and considered to be related to sulfasalazine. Sulfasalazine was discontinued and intravenous infusions of methylprednisolone combined with human immunoglobulin were given. At the same time, anti-infection, anti-allergy, and liver-protective treatments were given additionally. After 8 days of treatments, the rash began to subside and itching was improved; after 18 days, the rash basically subsided and laboratory tests showed the results returned to normal.
  • 中毒救治
    Zhao Ruizhan;Li Shuanlu;An Guohui
    . 2014, 16(2): 119-2.

    A 30-year-old male patient took about 300 pills of salbutamol (2 mg/pill ) by himself after a quarrel with his family and was hospitalized in emergency department. The patient had dizziness, headache, giddiness, palpitation and dry mouth, etc. and was treated with emetic and cathartic treatments, oral medicinal charcoal tablets for poison adsorption, correction of electrolyte imbalance, maintaining acid-base balance, and hemoperfusion combined with hemodialysis. Clinical symptoms improved 3 days later and he was discharged. And the patient had no uncomfortable feelings during follow-up visit 7 d later.

  • Liu Chenyun, Lin Zhaoxia, Zhao Xiaofang
    . 2015, 17(6): 464-465.
    A 34-year-old female patient received oral nifuratel 0.4 g thrice daily and nifuratel-nystatin vaginal suppositories 0.2 g twice daily. After 1 day of treatment, the patient developed scattered rashes and desquamation on her whole body, diffused hemorrhagic rashes on her lower extremities. Nifuratel was stopped. Twenty-one days later, the patient developed abdominal pain, dark urine, fatigue, and yellowish skin. Rashes and desquamation were not improved. The levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin (TBil), direct bilirubin, and prothrombin activity (PTA) were 945 U/L, 1 027 U/L, 226 U/L, 290.1 μmol/L, 225.9 μmol/L, and 53%, respectively. Hepatitis A, B, C, D, E virus infection markers were negative and the patient had no history of abnormal liver function. It was considered that the liver injury and exfoliative dermatitis were caused by nifuratel. Anti-allergic and hepato-protective treatments were given. After 3 months of treatments, the rashes basically subsided. The levels of ALT, AST, TBil, and PTA were 85 U/L, 47 U/L, 51.4 μmol/L, and 83%, respectively. At 75 days of follow-up, the patient′s results of liver function tests returned to normal, the rashes disappeared completely, and the levels of ALT, AST, TBil were 20 U/L, 26 U/L, and 5.4 μmol/L, respectively.
  • Zhuang Hongyan, Liu Shanshan, Du Haixia, Cui Yonghua
    . 2016, 18(3): 220.
    An 11-year-old female patient was given sertraline 25 mg once daily and quetiapine 25 mg once daily for childhood emotional disorders. The patient′s white blood cells count(WBC) was 4.6×109/L and neutrophil count(NEUT) was 1.8×109/L two days later. The patient was diagnosed as neutropenia. Quetiapine was stopped and sertraline was given continually. At the same time berbamine hydrochloride 84 mg thrice daily and leucogen 20 mg thrice daily were given. Six days later, the dosage of sertraline was increased to 50 mg once daily to improve the symptoms and vitamin B6 10 mg thrice daily was given. On day 13 of sertraline therapy, the WBC was 3.5×109/L and the NEUT was 1.4×109/L. Leukopenia was diagnosed. On day 24 of sertraline therapy, the WBC was 3.3×109/L and the NEUT was 1.4×109/L. Anduolin(安多霖) capsules 0.64 g twice daily were added to her regimen. Sertraline dose was reduced to 25 mg once daily the next day and was stopped 2 days later. Five days later, the patient′s WBC was 4.4×109/L and NEUT was 2.0×109/L. Then, fluvoxamine was given to improve mood. Seven days later, the patient′s WBC was 4.6×109/L and NEUT was 2.3×109/L.
  • 论著
    CUI Wen-hua;QIU Ze-wu;SUN Cheng-wen;WANG Zhe;PENG Xiao-bo
    . 2013, 15(2): 79-4.
    ObjectiveTo explore the significance of early measurement of plasma-paraquat concentrations in assessing the severity of liver and kidney injury and predicting the outcome in patients with acute paraquat poisoning (APP).MethodsThe case reports of patients with APP in Department of Gastroenterology, Affiliated Hospital of Academy of Military Medical Science from June 2006 to June 2012 were collected and retrospectively analyzed. The inclusion criteria were as follows: the patients were orally poisoned, without undergoing infusion and hemoperfusion treatment, the time from poisoning to admission ≤ 6 h. According to the plasma-paraquat concentrations measured on admission, the patients were divided into the low-concentration group (<0.5 mg/L), moderate-concentration group (0.5-2.0 mg/L), and high-concentration group (>2.0 mg/L). The highest values of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood urea, and serum creatinine levels detected during hospitalization in the 3 groups were compared. The mortalities in the 3 groups were calculated and compared.ResultsData of a total of 87 patients were collected according to the inclusion criteria. Of them, 48 patients were male and 39 were female with age of 9-76 (30±14) years. There were 31, 27, and 29 patients in the low-, moderate-, and high-concentration groups, respectively. The differences in gender, age distribution, and the time from poisoning to admission among the 3 groups were not statistically significant (P>0.05). The median (Q1, Q3) of the highest values of AST, ALT, total bilirubin, blood urea, and serum creatinine levels in the 3 groups were 39(18, 87), 126(92, 249), and 345(108, 666) U/L; 29(25, 37), 120(57, 222), and 233(106, 361) U/L; 24(18, 33), 31(22, 52), and 65(39, 86)μmol/L; 77(59, 136), 243(134, 421), and 295(248, 489) μmol/L; 8(5, 11), 15(13, 21), and 24(19, 27) mmol/L; respectively. The mortalities in the 3 groups were 3.2% (1/31), 44.4% (12/27), and 86.2% (25/29), respectively. Pairwise comparisons among the 3 groups were performed and the differences in all items mentioned above were significant statistically (P<0.05 or P<0.01). Conclusion
    Plasma-paraquat concentrations measured in the early stage of paraquat poisoning could be used to assess the severity of liver and kidney injury and predict the outcome in patients with APP.
  • 论著
    SUN Mei-ping;GU Kai-chen;MIAO Liang;XU Ruo-hui;LAN Bei
    . 2012, 14(6): 345-7.

    ObjectiveTo evaluate the operating quality of adverse events following immunization (AEFI) surveillance system and analyze the reported cases in Beijing during 2011 in order to provide the basis for further improvement of monitoring AEFI. Methods The data of individual cases of AEFI in Beijing during 2011 were collected through the AEFI information system of China, analyzed by descriptive epidemiological methods and evaluated according to the AEFI monitoring index. The diagnostic quality of cases of AEFI was investigated by quantitative questionnaire and qualitative group interview. ResultsEight hundred and sixty cases of AEFI were reported in Beijing during 2011. The reporting rate was 9.60 per 100 000 doses. Six of seven state indicators (report coverage rate in districts, reporting rate within 48 hours, investigation rate, input rate of questionnaire within 3 days, upload rate of investigation report within 7 days, and classification rate) were up to the standard of AEFI system except the integrality rate of key project in questionnaire. CDC of Beijing and districts held a total of 27 AEFI expert meetings during 2011. Ninety-five cases of AEFI were discussed and, among them, rare adverse reactions were 55, serious rare adverse reactions were 8, and 7 cases were excluded due to abnormal reactions. There were some differences in working condition among expert groups in different districts. Of 860 cases of AEFI, common adverse reactions were 526 (61.2%), abnormal reactions were 209 (24.3%), coincidental events were 117 (13.6%), psychogenic reactions were 8 (0.9%). The main biological products associated with AEFI were diphtheria, tetanus and acellular pertussis combined vaccine adsorbed (DPT) and measles and rubella combined vaccine, live. The main clinical presentations of AEFI were allergic rash (79.5%) and angioneurotic edema (90%). Allergic rash was mainly caused by measles rubella combined vaccine (37.7%). No accidents of vaccine quality and vaccination were reported. ConclusionThe operating quality of AEFI surveillance system in Beijing during 2011 is at higher level. However, the standardized management of AEFI expert group should be improved. The incidence of rare adverse reactions due to measles and rubella combined vaccine, live is higher, the further investigation and analysis should be performed.

  • 病例报告
    Zhu Aihua;Shi Jing;Ni Jingnian;Xu Yamei
    . 2011, 13(6): 373-2.

    An 88-year-old man received an IV infusion of cefoperazone sodium/sulbactam sodium 2 g twice daily for pulmonary infection. One week later, the patient developed thrombocytopenia and coagulation abnormalities. Laboratory tests revealed a platelet count of 22×109/L, a prothrombin time (PT) of 41 s, a prothrombin activity (PTA) of 17 %, a prothrombin time ratio (PTR) of 3.97, an international normalized ratio (INR) of 3.19. Coagulation abnormalities were considered to be related to cefoperazone sodium/sulbactam sodium and then the medication was discontinued. On day 3 of drug discontinuation, the patient developed aggravated coagulation abnormalities. Laboratory tests revealed the following results: PT 55 s, PTR 5.28, INR 4.05. An IV infusion of fresh frozen plasma and IM vitamin K1 were given. On day 3 of these treatments, his coagulation basically returned to normal, and laboratory tests revealed the following values: PT 12 s, PTA 113%, PTR 1.07, INR 1.06. On day 9 of the treatments, his platelet count was 197×109/L.

  • 综合报道
    . 1999, 1(3): 176-178.
    本文对近几年报道的使用甘露醇发生的主要不良反应作一综合报告,并提示该药应用时的注意事项。
  • 病例报告
    . 2000, 2(1): 55-55.
  • 中药不良反应
    . 2007, 9(2): 143-143.
  • 病例报告
    . 2005, 7(1): 58-59.
    A 35-year-old man was hospitalized with herpes on left neck and shoulder with pain for one week and lumbago for 3 days. He was diagnosed as zoster and treated with intravenous infusion of aciclovir 0.5g once daily prior to admission. The patient suddenly developed lumbago and limited movement after receiving the medication the second day, with percussion pain on bilateral kidney areas. The agent was withdrawn immediately. Ultrasound showed substantial echo increase in kidneys. It was considered that lumbago was associated with intravenous infusion of aciclovir. His symptoms lessened gradually after discontinuation of the medication.
  • 病例报告
    . 2003, 5(5): 340-340.
  • 文献题录
    . 2005, 7(2): 148-149.
  • 病例报告
    . 2005, 7(6): 450-450.
  • 病例报告
    Zhu Zhijian
    . 2008, 10(2): 143-2.

    A 56yearold man with hepatitis B and posthepatitic cirrhosis complicated by ascites was administered with 250 ml of glucose 5% mixed with adenosine triphosphate 40 mg and coenzyme A 100 U intravenously, and then furosemide 20 mg was added via Murphys dropper. Ten minutes later, the man developed pain over renal region. Abnormalities in urine routine and ultrasound B examinations were not found. His symptoms disappeared after receiving IM nefopam. The pain over renal region reappeared on repeated exposure to furosomide. Furosemide was discontinued and other drugs was continued, his symptoms disappeared.

  • 中药不良反应
    Ren Huali;Zhao Jingli;Zhao Hongfen;Li Xiaoxia
    . 2008, 10(2): 151-1.
    A 28yearold woman with mucocutaneous hemorrhoids and anal fissure received Jiuhuazhichuang suppositories. Three minutes later, she developed facial flushing with itching and numbness, swelling of the lips, nausea, vomiting,diarrhea, dizziness, and unconsciousness. Her blood pressure was 60/40 mmHg, her heart rate was 120 beats/min. After symptomatic and supportive therapy, she regained consciousness, and her symptoms were relieved.
  • 病例报告
    Meng Xiaobin;Zeng Huanghui;Lin Jianchang
    . 2009, 11(2): 136-2.
    An 87yearold woman took nifedipine 10 mg three times daily herself for hypertension. The next day, the patient developed flush with pruritus on her neck, trunk, abdomen and back, swelling of her extremities, and increased body temperature. After admission, an examination showed that her body temperature was 38℃, her respiratory rate was 98 breaths/min; her local skin presented with desquamation, and onefourth of her bodysurface was involved. Laboratory testing revealed the following: WBC count 17.5×109/L, neutrophilcount 14.8×109/L. Druginduced exfoliative dermatitis was diagnosed. Levocetirizine, calcium gluconate, cimetidine, and dexamethasone were given. Eight days later, her examination showed a temperature of 36.8℃, a respiratory rate of 20 breaths/min, a WBC count of 9.7×109/L, and a neutrophil count of 8.25×109/L. His flush and pruritus improved and the swelling of extremities subsided, then she was discharged.
  • Li Lihua;Zhao Yilei;Jiao Yi
    Adverse Drug Reactions Journal. 2010, 12(1): 44-2.
    A 42yearold woman received tamoxifen 10 mg once daily for longterm maintenance therapy after undergoing mammary cancer radical operation. Irbesartan 150 mg once daily was added to her regimen due to hypertension. One month later, the patient developed painful left cervical and axillary lymph nodes and left breast. Mammary cancer metastasis was excluded. The abovementioned symptoms were considered to be irbesartanassociated. Irbesartan was stopped and tamoxifen was continued. One week later, his symptoms disappeared. Subsequently, amlodipine and metoprolol were used for control of blood pressure and the abovementioned symptoms did not recur.
  • 病例报告
    . 2003, 5(2): 113-114.
  • 网络医药
    . 2004, 6(2): 109-112.
  • Yao Xiaoli, Xiao Weizhong
    Adverse Drug Reactions Journal. 2022, 24(8): 444-446. https://doi.org/10.3760/cma.j.cn114015-20211230-01314
    A 64-year-old male patient with Parkinson′s disease received long-term use of levodopa and benserazide hydrochloride, piribedil sustained-release tablets, and selegiline. Due to involuntary twisting of head and limbs, amantadine was added and dyskinesia was relieved. Five months later, the patient felt general fatigue and weakness, and the blood sodium was 120-mmol/L. He was given sodium supplementation treatment, and the blood sodium level rose briefly and then decreased again. Excluding other factors that could cause hyponatremia, it was considered that the hyponatremia was caused by syndrome of inappropriate antidiuretic hormone secretion, which was induced by amantadine. Amantadine was stopped, sodium supplement treatment was continued, and 7 days later, the blood sodium level gradually returned to normal. After stopping sodium supplementation, fatigue and weakness did not recur, and blood sodium level did not decrease at one month of follow-up.
  • 不良事件
    . 2004, 6(6): 421-421.
  • 病例报告
    . 2006, 8(5): 379-379.
  • 病例报告
    . 2003, 5(1): 45-45.
  • 病例报告
    . 2000, 2(3): 191-192.
  • 综述
    . 2000, 2(4): 213-216.
  • 病例报告
    . 2005, 7(5): 376-376.
  • 药物评介
    . 1999, 1(1): 60-62.
  • 病例报告
    . 2007, 9(2): 136-136.
  • 病例报告
    . 2007, 9(2): 136-137.
  • 病例报告
    Yuan Xiao;Sun Zimin;Wang Zuyi;Liu Huilan;Geng Liangquan;Tong Juan;Yao Wen
    . 2007, 9(6): 424-425.
    A 33-year-old man with chronic granulocytic leukemia was administered with busulfan,cyclophosphamide,and antithymocyte globulin successively for pretreatment before allogeneic hematopoietic stem cell transplant.On day 3 before transplant,he started receiving intravenous infusion of antithymocyte globulin 200 mg mixed with 500 ml of sodium chloride injection 0.9% at a rate of 25 to 50 ml/h.Three hours and a half later,the patient developed shivering,and his body temperature gradually rose to 39.6 ℃.He was given symptomatic treatment.After 8 hours of antithymocyte globulin infusion,the patient developed strong tea-colored urine.A routine urine test revealed the results as follows:protein(┼┼┼┼),pH 8.5,RBC(-),and occult blood(┼┼).Antithymocyte globulin was discontinued.He was treated with a large dose of sodium bicarbonate injection.The next morning,his urine color turned light,and his routine urine values were essentially normal.Then he was given the second dose of antithymocyte globulin …更多200 mg by intravenous infusion at a rate of 10 ml/h.Half an hour later,he presented with soy sauce-colored urine.Antithymocyte globulin was ceased again,and he was given sodium bicarbonate injection.Two days later,his urine color and urine values normalized.And then basiliximab was given instead of antithymocyte globulin for the pretreatment.The patient did not develop abnormal reactions.
  • SARS防治
    . 2003, 5(6): 361-364.
    目的:提高临床医生重视SARS患者支持疗法的意识,降低病死率。方法:调查SARS患者临床各期的静脉入量、热量及营养问题,分析上述情况对患者预后的影响。结果:早期入院治疗,给予适当的静脉补液及肺损伤期注意补充足够热量可明显改善SARS的预后;多数重症SARS患者在整个病程中都存在着不同程度的低白蛋白血症、贫血、血糖升高和低钙血症等营养问题。结论:早期治疗,注意适当静脉补液,纠正液体入量不足,采用静脉高营养治疗,尤其对重症SARS患者病程的各期及时发现和纠正各种营养问题,对改善SARS预后非常重要。
  • 病例报告
    Li Lihua;Zhao Yilei;Jiang Wei
    . 2010, 12(3): 210-1.
    A 34-year-old man with psychosis received sulpiride 100 mg twice daily. Four weeks later, the patient experienced involuntary tongue thrusting with salivation. Sulpiride was withdrawn and he was given scopolamine and diazepam. Three hours later, his conditions relieved and, three days later, the symptoms disappeared. Subsequently, his regimen was swtiched to olanzapine for psychosis. He had no recurrence at 2month follow up.
  • ZHU Zhong-hua;ZHU Hui-ya;LING Yun
    A 61-year-old woman with acute episodes of chronic cholecystitis received an IV infusion of cefotiam hydrochloride 2.0 g in 0.9% sodium chloride injection 100 ml twice daily, and an IV infusion of pantoprazole 60 mg in 0.9% sodium chloride injection 100 ml twice daily. On day 2, the patient′s body temperature rose, erythematous skin rashes appeared on her face and extremities, accompanied by itching. Cefotiam hydrochloride was stopped. She was treated with IV dexamethasone and IM promethazine. The above symptoms did not markedly improve. On day 3, skin rashes spread over her entire body, accompanied by throat discomfort, facial swelling, palpebral edema, and conjunctival congestion. Stevens-Johnson syndrome was diagnosed. Pantoprazole was stopped, glucocorticoid and antihistamine treatment was continued. On day 5, palpebral edema was relieved. On day 6, rashes on her limbs was significantly improved and facial swelling disappeared. On day 9, her generalized rashes basically subsided.
  • He Yanxia;Xue Bing
    . 2015, 17(1): 61-2.
    A 75-year-old woman with chronic obstructive pulmonary disease received sertraline 25 mg once daily for anxiety and depression. Her hemoglobin was 140 g/L and platelet count was 175×109/L before taking sertraline. Three days after drug administration, she presented with melena and was stool occult blood positive. Blood routine examination revealed that the hemoglobin was 60 g/L and platelet count was 2×109/L. Sertraline was stopped and two doses of platelet were transfused. Intravenous dexamethasone 5 mg was given. The next day, the platelet count was 15×109/L accompanied with the improvement in hematochezia. The platelet count reached 25×109/L and 85×109/L on the third day and tenth day after sertraline discontinuation respectively. On day 13, her platelet count returned to 105×109/L.
  • Wu Zeyang, Zhou Xiaoming, Gu Xiu, Chen Yu, Zhao Limei, Zhao Li
    . 2017, 19(2): 132-133.
    A 60-year-old man with septicemia received an IV infusion of tigecycline (first 100 mg, then 50 mg every 12 hours). The patient developed abdominal distension, pain, and tenderness at left lower abdomen on the tenth day of cumulative medication. Laboratory tests showed the following values: white blood cell (WBC) 18.4×109/L, neutrophile granulocyte 0.90, serum amylase 432 U/L, lipase 432 U/L, urinea amylase 389 U/L. The result of abdominal CT showed effusion in abdominal pelvis, exudation around duodenum and stomach. The patient was diagnosed as acute pancreatitis induced by tigecycline. The patient was told to fast. He accepted gastrointestinal decompression by indwelling gastric tube. Tigecycline was withdrawn. He received symptomatic treatments including acid suppression, inhibition of pancreatic secretion, and intravenous infusion. Six days after symptomatic treatment, the patient′s abdominal symptoms were disappeared. Laboratory test showed the following values: serum amylase 95 U/L, lipase 222 U/L, urinea amylase 93 U/L.
  • Pang Shangyi, Liu Chao
    . 2017, 19(4): 312.
    A 60-year-old female patient with chronic gastritis received oral rabeprazole sodium enteric-coated tablets 20 mg once daily for 2 weeks. Five weeks after the drug discontinuation, the patient presented with dry mouth, dry stool, and weight loss. Laboratory tests revealed the following levels: serum creatinine (Scr) 265 μmol/L, blood urea nitrogen (BUN) 13.6 mmol/L, albumin 41 g/L, urinary occult blood (++), urinary protein (+++), and urinary glucose (+++). One week later, the disease progression occurred, laboratory tests showed the following values: Scr 525 μmol/L, BUN 15.6 mmol/L, hemoglobin 85 g/L, potassium 3.4 mmol/L, iron 5 μmol/L, and 24-hour urine protein 2 100 mg. Acute renal injury, moderate anemia, and hypokalemia were diagnosed. She received oral prednisone acetate, sodium bicarbonate, gemcitabine, itopride hydrochloride, calcium carbonate, ferrous succinate, folic acid, uremic clearance granule and subcutaneous injection of recombinant human erythropoietin injection. Two weeks later, the values of Scr, BUN and 24-hour urine protein were 315 μmol/L, 13.8 mmol/L and 1 300 mg, respectively. Renal biopsy showed acute interstitial nephritis. The treatments were continued. After 5 weeks of treatment, Scr was 214 μmol/L, BUN was 10.8 mmol/L, hemoglobin was 129 g/L, 24-hour urine protein was 1 100 mg, urine occult blood (-), urine glucose (+).
  • XU Yan-gui
    . 2013, 15(6): 346-4.
    Extravasation of chemotherapy drugs for cancer could lead to local skin swelling, burning pain, vesicle, phlebitis, and even tissue necrosis. Moreover, surgical debridement and skin-grafting were needed for serious patients. The degree of injury generally includes local inflammatory response phase, venous inflammatory response phase, and tissue necrosis phase. According to the degree of irritation of issue after extravasation, the chemotherapy drugs could be divided into vesicants, stimulants, and non-stimulants. The drug should be stopped immediately once extravasation occurred. Moreover, aspirating endovascular and extravascular drug and early therapy containing cold compress, fomentation, and wet compress with drug should be given to avoid much serious complications. The important measures of preventing extravasation due to chemotherapy drugs for cancer include strengthening safe medication education for patients and their families and mastering correct method of drug use.
  • 病例报告
    Ouyang Hongtao;Huang Xiaofang
    . 2011, 13(6): 383-3.
    A 16-year-old woman with schizophrenia received the initial dose of quetiapine fumarate was 100 mg every night, this dosage was gradually increased, until the dosage reached 600 mg/d (200 mg at daytime, 400 mg at night) on day 40 of treatment. The same day, the patient developed involuntary head shaking and blinking. Her symptoms were considered to be associated with quetiapine fumarate, therefore the drug dosage was reduced to 400 mg at night. On day 3, the patient progressed to acute dystonia. Quetiapine fumarate was discontinued immediately and switched to oral olanzapine. Meanwhile, she received an IM scopolamine butylbromide 0.3 mg, an IV infusion of 5% glucose 500 ml and an IV infusion of glucose and sodium chloride 1000 ml. The next day, her dystonia symptoms disappeared.
  • 病例报告
    . 2007, 9(1): 48-48.
    Summary: A 62-year old man with multiple myeloma was administered with thalidomide 50 mg daily by mouth. His heart rate was decreased from 88 beats/min to 62 beats/min after 4 days therapy, and to 42 beats/min after 5 days therapy. Electrocardiograph showed sinus bradycardia. Thalidomide therapy was discontinued, The patient was prescribed intramuscular atropine 0.5 mg every four hours for 4 times, and his heart rate was increased to >60 beats/min.
  • 病例报道
    . 1999, 1(2): 116-116.
  • 国外文献题录
    . 2004, 6(2): 134-136.
  • 病例报告
    . 2002, 4(3): 149-149.
  • 病例报告
    . 2005, 7(2): 132-132.
  • 病例报告
    . 2004, 6(3): 177-178.
    Summary A 41-year-old woman experienced breast cancer removed by surgery with chemotherapy and radiotherapy. 15 days after taking letrozole 2.5mg daily by mouth, the patient felt flustered and the heart rate was 100-110 beats/min. Heart examination by color ultrasound showed normality while ECG showed atrial premature beat, 6-20 beats/min. The patient's heart rate and ECG recovered gradually after a stop of medication.7 days later,taking another letrozole caused the above symptoms again.The symptoms resolved after discontinuation of letrozole.
  • 病例报告
    . 2001, 3(4): 257-257.
  • 药物误用
    Sun Jingwen;Yang Fang
    . 2009, 11(5): 351-2.
    A 10 year and 4 month old boy with epilepsy received lamotrigine 12.5 mg once daily and sodium valproate 0.13 g thrice daily. Four days later, the patient developed generalised red rash with pruritus. His symptoms disappeared after lamotrigine discontiuation.The above-mentioned symtoms recurred after readministration of lamotrigine, followed by fever. Despite discontinuation of lamotrigine, his rash did not relieved; on the contrary, his rash gragully increased. He presented with generalised skin flushing with swelling, rhagade, rupture, and scales. The therapy was given, but this had no effect. The boy experienced repeated fever and yellowish sclera. Liver function examination revealed the following levels: ALT 408 U/L, AST 228U/L, γ-GT 336 U/L, TBil 162.4μmol/L, DBil 112.4 μmol/L, IBil 50 μmol/L; and routine urine tests showed urobilinogen (+) and bilirubin (++). The symptoms gradually improved after anti-infective and antiallergic treatment.
  • 安全用药
    . 2002, 4(6): 376-378.
  • 实验论著
    Luo Yongwei;Shi Chang;Wu Chunqi;Wang Quanjun;Liu Yanqing;Yang Baohua;Hu Zhonghui;Zhang Yujie;Liao Mingyang
    . 2009, 11(2): 96-4.
    Objective: To evaluate the effects of the new antineoplastic compound MC004 on embryonic development. Methods:Midbrain cells were harvested from 13dayold rat embryos, and diluted until the resulting cell density of suspension was 5×106/ml; the survival rate of the cells was >95%. Each well in 6 and 9 well plates was respectively poured into 10 μl of cell suspension, then was incubated at 37℃ with 5 % carbon dioxide for 2 hours. After incubation, different concentrations of MC004(5, 2.5, 1.25, 0.625, 0.312 5, 0.156 25, 0.078, 0.039, 0.019 5, 0.009 8, 0.004 9 μg/ml)was added to each well in 6 well plates until the final volume was 2 ml, and different concentrations of MC004(5, 2.5, 1.25, 0625, 0.312 5, 0.156 25, 0.078, 0.039, 0.019 5μg/ml)was added to each well in the 96 well plates until the final volume was 200 μl. The corresponding volume of Ham’s F-12 complete medium was used in the control group. After 5 days of culture in vitro, the culture medium was removed and the cells were fixed and stained. The number of colony formation in 6 well plates was counted under light microscopy, then the 50% inhibition concentration of differentiation was calculated. The cells absorbency of each well in 96 well plates was measured with microplate reader at 570 nm, then the 50% inhibition concentration of proliferation was calculated. Results: In different MC004 dose groups, the number of colony formation and nerve fiber bundle among colonies decreased. The doseeffect relationship was marked. The 50% inhibition concentration of differentiation to MC004 was 0.062 4 μg/ml. The 50% inhibition concentration of proliferation to MC004 was 0.196 3 μg/ml. Conclusion: MC004 could nonspecifically inhibit cell proliferation and differentiation in vitro, and it might have teratogenetic effect.
  • 病例报告
    Li Nan;Yang Bilian;Li Yuanwen;Sun Zhanxue
    . 2009, 11(1): 65-1.
    A 68yearold man with hypertension, who had been receiving valsartan 80 mg once daily for 1 year, took terbinafine 0.25 g once daily for onychomycosis. After twenty days of treatment, the man developed hypogeusia. After twelve weeks of treatment, he lost all sense of taste. Terbinafine was discontinued. Two months later, his sense of taste returned to some extent.
  • 临床论著
    Teng Guojie;Nie Xiuhong
    . 2009, 11(4): 223-4.
    Objective: To analyze the risk factors for resistance development of Pseudomonas aeroginosa isolates found in lower respiratory tract specimen from patients undergoing mechanical ventilation in order to provide scientific basis for rational antibacterial use. Methods:From January 2006 to January 2009, seventy-eight patients undergoing mechanical ventilation, who had a sputum culture positive for Pseudomonas aeruginosa, were enrolled in the investigation. The time to resisance development of Pseudomonas aeroginosa to therapeutic drugs was observed, and the age, gender, and underlying diseases of patients, APACHE Ⅱ scores, medication use one week before therapy, the time to stay in the ICU before therapy, and the effects of concomitant use of vancomycin or fluconazole on resistance of Pseudomonas aeruginosa were analysed. Results: The 78 patients comprised 37 men and 41 women with age of 45-82 years [mean age (68±10) years]. Of the 78 patients, 43 received an IV infusion of ceftazidime 2 g in 0.9% sodium chloride 100 ml once every 8 hours, and 35 received an IV infusion of piperacillintazobactum 4.5 g in 0.9% sodium chloride 100 ml once every 6 hours. The resistance development of Pseudomonas aeruginosa was seen in total 28 patients. The time to resistance development was 424 days. Of the 43 patients receiving ceftazidime, 21 developed bacterial resistance. The mean time to resistance development was 8.9 days. Of the 35 patients receiving piperacillintazobactam, 7 developed bacterial resistance. The mean time to resistance development was 16.7 days. Multivariate logistic regression analysis showed that the use of imipenem one week before the isolation of Pseudomonad aeruginosa was the independent risk factor for the resistance development of Pseudomonas aeruginasa. Conclusion: The risk for the resistance development of Pseudomonas aeruginosa in ceftazidine therapy is higher than in perperacillintazobactam therapy. The patients who have received imipenem before therapy may increase the risk for the resistance development of Pseudomonas aeruginosa.
  • 安全信息
    . 2008, 10(3): 222-1.
  • Wang Xiao, Liu Huaxue
    Adverse Drug Reactions Journal. 2022, 24(1): 42-43. https://doi.org/10.3760/cma.j.cn114015-20210223-00209
    A 50-year-old male patient had diarrhea due to unclean diet. According to the doctor′s advice, the patient received the first dose of montmorillonite powder 6 g orally. The next day, he developed abdominal pain, abdominal distention, and no defecation. Enema was ineffective. Physical examination showed abdominal distension, percussion drum sound, obvious abdominal tenderness, and reduced bowel sound. The patient was diagnosed with complete ileus by abdominal CT. After 5 days of symptomatic treatments such as diet prohibition, gastrointestinal decompression, and enema defecation, the patient returned to normal exhaust and defecation. After excluding other intestinal lesions through abdominal X-ray, enhanced CT, and enteroscopy, it is considered that the patient′s complete ileus was related to montmorillonite powder.
  • Deng Xiaoqin
    Adverse Drug Reactions Journal. 2021, 23(10): 550-552. https://doi.org/10.3760/cma.j.cn114015-20201228-01294
    An 86-year-old male patient received aspirin enteric-coated tablets (100-mg orally once daily) and atorvastatin calcium tablets (10-mg orally once daily) due to cerebral infarction. After 1 week, enteric-coated tablets were switched to clopidogrel (75-mg orally once daily), and Xueshuantong injection(血栓通注射液) (450-mg/d) and cattle encephalon glycoside and ignotin injection (5-mg/d) were given by IV infusion. After 4 days of treatment, the platelet count (PLT) decreased from 132×109/L before treatment to 52×109/L. Clopidogrel was discontinued, but PLT continued to decrease, accompanied by fever. After 2 days of drug withdrawal, PLT decreased to 4×109/L;after 3 days of drug withdrawal, PLT was 1×109/L and the patient developed gingival bleeding. Leucogen was given orally, platelets and coagulation factors were supplemented intravenously, but PLT did not increase. On the 5th day of drug withdrawal, the patient gradually developed unconsciousness and rapid atrial fibrillation and finally died due to respiratory and circulatory failure. After the patient died, thrombotic thrombocytopenic purpura due to clopidogrel was diagnosed.
  • Li Xiang, Zhou Yan, Li Qin
    Adverse Drug Reactions Journal. 2023, 25(3): 185-187. https://doi.org/10.3760/cma.j.cn114015-20220412-00315
    An 80-year-old male patient with lower extremity atherosclerosis obliterans received urokinase 20-000 U/h for thrombolytic therapy. His blood pressure before the treatment was 120/60-mmHg. Blood pressure increased progressively to 224/131-mmHg after 6 hours of thrombolysis. Urapidil 40-mg/h was given by microinjection pump and blood pressure was 200/91-mmHg 1 hour later. The blood pressure decreased to 150/80-mmHg after reducing the urokinase to the minimum maintenance dose of 4-000 U/h. The blood pressure rose again 2.5-hours after the original dose of urokinase was given again. After stopping urokinase again, the blood pressure decreased to 160/97-mmHg and remained stable. Since then, there was no increase in blood pressure.
  • Cai Haodong
    Adverse Drug Reactions Journal. 2024, 26(3): 129-132. https://doi.org/10.3760/cma.j.cn114015-20231218-00892
    Old drugs are generally considered as drugs that have been on the market for many years and are well known by medical workers and the public. There are still many unsolved problems about the safety of older drugs. Some adverse reactions of old drugs may not be fully understood at present, the safety of their application in special populations still needs long-term monitoring, the study on mechanism of many adverse reactions of old drugs need to be strengthened, and most adverse reactions lack specific diagnostic biomarkers and effective prevention and treatment measures. The adverse reaction content in the old drug labels needs to be continuously improved, and many safety issues in drug application still require standardized expert consensus and guidance.
  • Yan Yuanmei, Zheng Yuexin, Mai Lusi, Chang Huili
    Adverse Drug Reactions Journal. 2024, 26(5): 280-284. https://doi.org/10.3760/cma.j.cn114015-20231222-00927
    Objective To explore the influencing factors of coagulation disorders caused by cefoperazone sodium and sulbactam sodium in patients with chronic renal insufficiency. Methods The medical records of adult patients with chronic renal insufficiency, who were hospitalized and treated with cefoperazone sodium and sulbactam sodium in the Department of Nephrology of the Affiliated Qingyuan Hospital, Guangzhou Medical University, Qingyuan People′s Hospital from January 2021 to December 2022, were collected. Patients who developed coagulation disorders related to cefoperazone sodium and sulbactam sodium were imputed as having an end-point event, and the occurrence of end-point events in these patients was analyzed descriptively. According to whether an end-point event occurred, patients were divided into end-point event group and non-end point event group. Univariate and multivariate logistic regression analysis were performed on the risk of end-point events. Results A total of 121 patients with renal insufficiency were included in the analysis, including 76 males (62.8%) and 45 females (37.2%), aged (66±13) years. Among 121 patients, 39 (32.2%) had end-point events, and 6 (5.0%) had clinical bleeding. The results of univariate analysis showed that the differences in age, renal replacement therapy, and daily and total doses of cefoperazone sodium and sulbactam sodium of patients between 2 groups were statistically significant (all P<0.05). Multivariate logistic regression analysis was performed using the occurrence of end-point events as dependent variables, and age, renal replacement therapy, and daily and total doses of cefoperazone sodium and sulbactam sodium as independent variables. The results showed that only older age was an independent risk factor for the occurrence of end-point events (odds ratio=1.044, 95% confidence interval: 1.004-1.086, P=0.029). Conclusions Patients with renal insufficiency have a higher risk of coagulation disorders in treatment with cefoperazone sodium and sulbactam sodium, and older age is an independent risk factor. Cefoperazone sodium and sulbactam sodium should be used cautiously in elder patients, and coagulation function monitoring should be strengthened in clinical use.
  • Zhang Hongtao, Wang Zhikui
    Adverse Drug Reactions Journal. 2023, 25(2): 122-125. https://doi.org/10.3760/cma.j.cn114015-20220822-00771-1
    A 59-year-old female patient received treatments of improvement of heart function, anti-rheumatism (oral total glucoside of white paeony capsules 0.6 g twice daily, oral iguratimod 25-mg twice daily), and anti-infection, etc. due to rheumatic heart disease, acute exacerbation of chronic cardiac dysfunction, rheumatoid arthritis, and pulmonary infection. Before medication, the prothrombin time (PT) was 15.5-s, and the international normalized ratio (INR) was 1.2. Considering that the patient had valvular heart disease and mural thrombus in the left atrium, oral warfarin 2.5-mg once daily was added the next day. PT was prolonged and INR increased. On the 10th day of warfarin application, her PT was 45.0-s and INR was 4.8. Warfarin was discontinued and the dose of iguratimod was reduced to 25-mg orally once daily. On the 2nd day of warfarin discontinuation, PT was 53.2-s and INR was 5.9; on the 3rd day, PT was 80.8-s and INR was 10.1. Then iguratimod was stopped and vitamin K1 was given. After 3 days, the PT was 22.4-s and INR was 2.0. Later, oral warfarin 2-mg once daily was added due to the disease condition. The PT was 19.8 to 27.4-s and INR was 2.1 to 2.9. It was considered that the prolonged PT in the patients might be related to the combination of iguratimod and warfarin.
  • Liu Cunfei, Liu Wenqi, Li Zhengrong, Zhu Zongfa, Wang Yuxi, Zhang Shouwen
    Adverse Drug Reactions Journal. 2025, 27(2): 120-122. https://doi.org/10.3760/cma.j.cn 114015-20240412-00247
    A 66-year-old female patient with multiple chronic diseases was on long-term treat- ment with digoxin, spironolactone, metoprolol, atorvastatin, dapagliflozin, and entecavir, with no abnormality platelet count (PLT). Due to hypertrophic obstructive cardiomyopathy and atrial fibrillation, digoxin was discontinued, and rivaroxaban 15 mg once daily orally was added to prevent thrombosis. Concurrently, furosemide, sacubitril valsartan, meglumine adenosine cyclophosphate, and silibinin was given for cardiac load reducement, blood pressure control and heart failure improvement, myocardial nutrition, and liver function improvement, respectively. After the initiation of this regimen, the patient′s PLT gradually decreased and was 51×109/L on day 13. Drug-induced thrombocytopenia was considered, with rivaroxaban being the likely causative agent. Rivaroxaban was then switched to warfarin, methylprednisolone 40 mg was administered intravenously once, and the remaining medications were continued. The patient′s PLT gra- dually increased. On day 11 after discontinuing rivaroxaban, the PLT was 155×109/L. At a 2-week follow- up, PLT of the patient was 169×109/L.
  • 病例报告
    Wu Xiuping
    . 2009, 11(3): 213-2.

    A 63-year-old man was hospitalized with angina pectoris. On admission, his blood pressure was 130/80 mm Hg. After hospitalization, he received oral administration of aspirin, simvastatin, and Tongxinluo, followed by an IV infusion of nitroglycerin 10 mg dissolved in 250 ml of glucose 5%. The patient developed increased blood pressure (150/90 mm Hg), headache, and chest distress half an hour after the first infusion start. The next day, headache, chest distress, and increased blood pressure (170/100 mm Hg) recurred 5 minutes after the second infusion start. Subsequently, nitroglycerin was stopped; all his other medications were continued. His blood pressure normalized.

  • 病例报告
    . 2006, 8(6): 457-457.
  • 病例报告
    . 2003, 5(4): 255-255.
  • 病例报告
    . 2002, 4(2): 86-86.
  • 不良事件
    . 2005, 7(4): 308-308.
  • 病例报告
    . 2005, 7(3): 210-211.
  • 病例报告
    . 2002, 4(1): 25-25.
  • 病例报告
    . 2002, 4(4): 280-280.
  • 中毒救治
    . 2002, 4(5): 320-320.
  • WHO信息
    . 2003, 5(5): 354-354.
  • 病例报告
    . 2006, 8(1): 7-7.
  • 病例报告
    . 2006, 8(2): 133-133.
  • 病例报告
    . 2007, 9(1): 51-52.
  • 病例报告
    . 2003, 5(6): 392-392.
  • 病例报告
    . 1999, 1(3): 183-184.
  • 病例报告
    . 2007, 9(2): 133-134.
  • 中药不良反应
    Wang Qi
    . 2007, 9(4): 294-301.
    A 32-year-old man with waist sprains pasted a Jieguling patch.Four hours later,he developed facial oedema,sporadic rash and vesicle on the skin of waist,back,limbs,and neck,and accompanied a mild fever(T 38 ℃).Two days later,he was hospitalized.A laboratory test showed his renal function was normal.Then he was given dexamethasone 5 mg intravenously once daily.After one day of therapy,his symptoms were obviously relieved.Eleven days later,he almost restored.
  • 安全信息
    . 2011, 13(3): 204-1.
  • 病例报告
    Sun Lijie;Liu Shuwang;Chen Baoxia;Zhang Yongzhen;Gao Wei
    . 2010, 12(5): 348-2.
    A 77yearold man underwent subcutaneous injection of nadroparin calcium 6 150 U every 12 hours as preventive anticoagulation treatment before radiofrequency catheter ablation. Two days later, the patient developed dizziness, faint, abdominal pain, and a palpable mass in his abdomen. Nadroparin calcium was withdrawn. Subsequently, he vomited coffeegroundlike gastric content 200 mL, and his blood pressure and heart rate were 80/50 mm Hg and 110 beats/min, respectively. CT showed abdominal masses. The next day, he experienced ecchymosis at the left lumbo-abdominal site and a markedly enlarged abdominal mass with elevated tension and obvious tenderness. His hemoglobin was 74 g/L. Abdominal ultrasongraphy revealed slight effusion around the liver, kidney, spleen, and in his abdominal cavity. His hemoglobin was 80 g/L 48 hours after the withdrawal of nadroparin calcium. Subsequently, he was given symptomatic and supportive treatments and the abovementioned symptoms were alleviated gradually. Four days after drug withdrawal, the patient began to eat liquid food and gastrointestinal hemorrhage did not recur anymore. His hemoglobin was 120 g/L 4 weeks after drug withdrawal and he remained in a stable condition during 8 months of follow-up.
  • 病例报告
    He Yonga;Xu Xiuyunb
    . 2010, 12(6): 445-2.
    A 76yearold women received nimodipine,clopidogrel,  troxerutin, and oxiracetan for treating acute cerebral infarction and essential hypertension. On hospital day 3, irbesartan 0.15 g once daily was added to her regimen in an attempt to control her hypertension. After 7 days of treatment, her BP was 125/60 mm Hg and her condition improved, and then she was discharged. After discharge, she continued to take clopidogrel, nitredipine, nimodipine, hydrochlorothiazide, and irbesartan. On day 5 after discharge, she had an examination in the outpatient clinic and her renal function tests showed BUN 14.42 mmol/L, SCr 114.0 μmol/L, potassium 6.89 mmol/L, BP 150/70 mm Hg. She was diagnosed with hyperkalemia and hospitalized again. She underwent diuresis and potassium elimination. The increased serum potassium level was considered to be related to antihypertensive agents, and then irbesartan and nitrendipine were discontinued and changed to controlledrelease nifedipine 30 mg once daily. Three days later, her serum potassium level and renal function normalized, and she was discharged. A review of her history showed that, about one year earlier, she had received candesartan cilexetil and had developed increased serum potassium levels.
  • LIU Cai-hong;HE Yong
    . 2013, 15(5): 297-2.
    A 36-year-old female patient with open bone defect received external fixation. She received oral Xianlinggubao capsules 1.5 g twice daily for postoperative recovery. Five hours after taking the first dose, a few red papules appeared on her both knee joints. The medicine was not stopped. The red papules spread all over the body on the next day. Xianlinggubao capsules was stopped and loratadine 10 mg once daily was given. Three days later, the skin rashes became darker in color than before. Loratadine was continued for 2 days. Four weeks later, the skin rashes basically subsided.
  • Huang Xiuman, Zhu Hong, Li Xinqing, Tong Weihang
    . 2017, 19(3): 213.
    A 65-year-old female patient with hepatitis B cirrhosis, pulmonary infection, abdominal infection and respiratory failure received lactulose oral solution, furosemide, spironolactone, entecavir, potassium chloride injection, polyene phosphatidyl choline, ademetionine 1,4-butanedisulfonate, reduced glutathione, human albumin, thymopentin, vitamin K1, L-ornithine L-aspartate, piperacillin sodium tazobactam sodium, teicoplanin, methylprednisolone sodium succinate, compound glycyrrhizin, lanso-prazole, kuhuang injection(苦黄注射液) and salbutamol sulfate solution. Amiodarone hydrochloride injection 0.15 g was given to the patient by slow intravenous infusion due to atrial fibrillation, and then the drug was diluted by 5% glucose injection to 10 mg/ml by a continuous infusion pump delivering 3 ml/h. On day 2, scattered rash appeared on her left thigh. On day 3, the rash extended to the left leg, piperacillin sodium tazobactam sodium and teicoplanin were stopped. She was given intramuscular injection of promethazine hydrochloride 25 mg and intravenous injection of calcium gluconate 1 g, the rash area decreased. That night, the heart rate of the patient was up to 128 beats/min, and the injection pump speed of amiodarone hydrochloride was adjusted for 6 ml/h. The next day, the rash throughout the limbs and chest, kuhuang injection was stopped and oral cyproheptadine hydrochloride 4 mg twice daily was given. On day 7, the patient developed generalized diffuse erythema, thymopentin and compound glycyrrhizin were stopped. On day 8, the rash exacerbated accompanied by desquamation. Scarlatiniform erythema drug eruption induced by amiodarone hydrochloride was considered. Amiodarone hydrochloride was withdrawn. She was given intravenous injection of dexamethasone 10 mg and calcium gluconate 1 g. The next day, the rash subsided significantly.
  • Zhang Lingli, Peng Rui, Peng Yan
    . 2015, 17(4): 257.
    ObjectiveTo evaluate the relationship between the uridine diphosphate-glucuronosyl-transferase 1A1 (UGT1A1)*6 polymorphisms and grade 3-4 neutropenia and diarrhea induced by irinotecan.MethodsThe databases of PubMed, Science Direct, Wiley Online Library, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Database and VIP from the inception to January 15, 2015 were searched. The clinical research papers which were about the relationship between the UGT1A1*6 polymorphisms and grade 3-4 neutropenia and diarrhea induced by irinotecan were collected. The quality of methodology in enrolled papers were evaluated. The software Review Manager 5.3 was used for Meta-analysis. The evaluating indicators of the relationship between UGT1A1*6 and the adverse reactions of irinotecan were odds ratio (OR) and 95% confidence interval (CI).ResultsA total of 14 papers were enrolled into this Meta-analysis. The numbers of papers in Chinese and English were 5 and 9, respectively and all the papers were from Asian countries. The result of Begg test showed that there were no obvious publication bias in the enrolled papers. The results of Meta-analysis showed that compared with the patients who carried UGT1A1*1/*1 (wild type),the risk of grade 3-4 neutropenia induced by irinotecan in the patients who carring UGT1A1*6/*6 (homozygous mutation) was significantly increased (OR=3.01,95%CI:2.01-4.50,P<0.000 01). Compared with the patients who carried UGT1A1*1/*1 (wild type),the risk of grade 3-4 diarrhoea induced by irinotecan in the patients carring UGT1A1*6/*6 (homozygous mutation) and the patients carring UGT1A1*1/*6 (heterozygous mutation) were significantly increased (OR=3.79,95%CI:2.38-6.04,P<0.000 01;OR=1.68,95%CI:1.16-2.42,P=0.006). ConclusionsThe polymorphisms of UGT1A1*6 are associated with grade 3-4 neutropenia and diarrhea induced by irinotecan. The risk of grade 3-4 neutropenia due to irinotecan in the patient carring UGT1A1*6 homozygous mutation is increased. The risk of grade 3-4 diarrhoea induced by irinotecan in the patients carring UGT1A1*6 homozygous mutation and heterozygous mutation is increased.
  • 论著
    Liu Yamin;Shao Hua;Li Weilan;Zhi Hong;Luo Can
    . 2014, 16(1): 10-5.

    ObjectiveTo explore the relationship between the response variability in patients with acute coronary syndrome (ACS) treated with clopidogrel and the recurrent cardiovascular events.MethodsThe ACS patients received loading dose of clopidogrel (300 mg/d) on the first day of hospitalization or before percutaneous coronary intervention, then received maintenance dose of clopidogrel (75 mg/d) from the second day, in addition, all patients received aspirin (100 mg/d) for one year. The patients′ maximal aggregation rate (MAR) and inhibition of platelet aggregation(IPA)were measured before and 24 hours after administration of loading dose of clopidogrel. The patients were divided into non-response to clopidogrel, low-response to clopidogrel, and response to clopidogrel groups according to the IPA. The patients were followed-up at the end of 1, 3, 6, and 12 months after administration, respectively. The situation of recurrent cardiovascular (CV) events including cardiovascular death, acute and subacute stent thromboses, recurrent acute coronary artery syndrome, and ischemic stroke were recorded. The differences in accumulative incidence of recurrent CV events among the 3 groups were compared by Kaplan-Meier survival analysis.ResultsA total of 190 patients with ACS who were hospitalized in the Department of Cardiology, Zhongda Hospital, Southeast University from October 2009 to March 2013 were enrolled into the study, comprising 111 males and 79 females with an average age of (66.1±7.8) years. There were 53, 46, and 91 patients in the non-response to clopidogrel group, the low-response to clopidogrel group, and the response to clopidogrel group, respectively. The differences in the sex composition, combined risk factors, and drug combination among the 3 groups were not significant (all P>0.05). The average age in the non-response to clopidogrel group [(69.1±7.8) years] was older than that in the response to clopidogrel group [(64.3±7.4) years] (P<0.05). The accumulative incidence of recurrent CV events on 1, 3, 6, and 12 months in the non-response to clopidogrel group [11.3%(6/53)、20.8%(11/53)、22.6%(12/53) and 35.8%(19/53) were significantly higher than those in the response to clopidogrel group [1.1%(1/91)、1.1%(1/91)、2.2%(2/91) and 9.9%(9/91)] (all P< 0.05). The results of Kaplan-Meier survival analysis showed that the accumulative incidence of recurrent CV events in the non-response to clopidogrel group were significantly higher than those in the low-response to clopidogrel group (P<0.05) and the response to clopidogrel group (P<0.01). ConclusionsThe response variability to clopidogrel of patient with ACS may be associated with recurrent CV events. The patient who received clopidogrel should be given the examination of MAR and IPA in order to decrease or avoid the recurrent CV events.

  • Song Haoxin, Zeng Linan, Xu Bei, Chen Zhe, Lin Mao, Yi Qiusha, Zhang Lingli
    . 2018, 20(3): 216-219.
    Medication safety officer (MSO) is an expert and manager of medication safety. Management of medication safety by MSO has been popularized and plays an important role in the medical institutions of the United States (US) and the United Kingdom (UK). The results of systematic search and analysis of literature showed that the setting of MSO in US and UK was mainly based on various characteristics of the adverse drug events (for example, the large number, high possibility for patient damage and economic loss, poor quality of the reports,inadequate management and preventability),and aimed to reduce its occurrence and then to guarantee the medication safety in patients. In US and UK, the MSOs mainly worked in large hospitals or large health care provider organizations, while the position level was not clearly defined. Responsibilities of MSOs mainly included the formulation and practice of a medication safety program, supervision and improvement of medication safety system, providing professional advice on medication safety, management and reporting of medication safety information in internal medical institution, receiving and transmitting medication safety information outside and carrying out medication safety training. In addition, the US put forward some specific qualification requirements for the position, including educational background, practicing qualification, related training experience, etc. The setting of MSO may be one of the effective measures to solve the problem of medication safety. It is suggested to set up a MSO management system in China′s medical institutions and actively explore a novel management mode of medication safety in China.
  • Li Zhengrong
    . 2015, 17(5): 373.
    A 30-year-old female patient received an IV infusion of cefotaxime sodium 1.0 g for toothache. About 20 minutes later, the patient developed chest tightness, palpitation, and limbs shaking. The drug was immediately stopped and an IV injection of dexamethasone was given. However, the symptoms were not improved and the patient was presented to emergency department in our hospital. On admission, electrocardiogram revealed acute myocardial ischemia, troponin T (TnT) 0.033 μg/L, creatine kinase (CK) 175 U/L, creatine kinase isoenzyme MB (CK-MB) 2.95 μg/L. About 0.5 hour of admission, the patient developed asthmatic symptoms and coughed up pink frothy sputum. Ventilator support, morphine, torasemide, dopamine, nitroglycerin, and diprophylline were given. About 4.5 hours of admission, her symptoms were improved. About 7 hours of admission, TnT was 0.551 μg/L, CK-MB 2.95 μg/L, myohemoglobin 149 μg/L. Five days of admission, ECG returned to normal and 1 week later, TnT, CK-MB and myohemoglobin levels returned to normal.
  • Lyu Shichen;Liu Lingling
    . 2015, 17(1): 57-2.
    A 87-year-old female patient received an intravenous infusion of levofloxacin lactate (300 mg/100 ml) and vitamin C 1.0 g for community-acquired pneumonia. Fourteen hours later, about 40 minutes after the second levofloxacin lactate infusion start, the patient presented with chill, shortness of breath, and vomiting and the infusion was stopped immediately. And then she developed respiratory and cardiac arrest. After 1 minute of cardiopulmonary resuscitation, she returned to normal breath and heartbeat and experienced atrial fibrillation with a heart rate of 150 beats/min. About 30 minutes of nitroglycerin infusion via pump start, the patient developed suddenly unconsciousness and ventricular tachycardia and returned to sinus rhythm after undergoing electroversion. Fifteen minutes later, the electrocardiogram showed torsades de pointes with a heart rate-adjusted QT interval of 557 ms. Nitroglycerin was withdrawn and amiodarone was given. Torsades de pointes did not recur. At the next night, her electrocardiograph monitoring revealed frequent torsades de pointes. Amiodarone was given immediately and, about 15 seconds later, she returned to sinus rhythm. Hereafter, the patient did not developed torsades de pointes again.
  • Pan Kunming, Ma Lingyun, Zhou Ying, Yang Li, Cui Yimin
    . 2017, 19(6): 443.
    Vancomycin (VAN) is an important drug for the treatment of severe Gram-positive bacterial infection. Acute kidney injury (AKI) is main adverse reaction of VAN. However, the mechanism of VAN-associated AKI (VA-AKI) remains unclear and current evidence suggests that it may be associated with renal tubular injury induced by VAN. Elderly population, poor pathophysiological status, accompanied by nephrotoxic drugs, long length of VAN therapy and higher VAN serum trough concentration are risk factors of VA-AKI and obesity shows no association with VA-AKI. The influence of the population of newborns and children, VAN administration method on VA-AKI remains controversial. For the patient concomitant of risk factors, more targeted protection and prevention should be given during clinical treatment.
  • . 2013, 15(5): 241-3.
  • 中药不良反应
    HU Yu;CHEN Gang;ZHOU Li-hong
    . 2013, 15(2): 115-1.
    A 76-year-old man was administered IV safflower injection 20 ml and IV Shenqi Fuzheng injection (参芪扶正注射液) 60 ml once daily for worsened left foot pain accompanied by arthralgia in his left knee. On day 7, he developed subconjunctival ecchymosis with a diameter of 5 mm on the nasal side of his left eye. Safflower injection was stopped and Shenqi Fuzheng injection was continued. Meanwhile, he was given symptomatic therapy. Six days later, his ecchymosis gradually resolved and, nine days later, disappeared completely.
  • 病例报告
    ZHAO Yi;LI Si-zhao;LI Xiao-xia
    . 2012, 14(4): 237-4.
    Two patients developed pulmonary tuberculosis after receiving infliximab treatment. Patient 1, a 23-year-old male patient with ankylosing spondylitis, received oral methotrexate, leflunomide and loxoprofen and an IV infusion of infliximab. The initial dose of infliximab was 200 mg, followed by the same dose at weeks 2, 6 and 8. The patient developed fever, cough and expectoration two months after the fourth infusion. The serum mycobacterium tuberculosis antibodies were positive. His chest X-ray showed diffuse miliary shadows in both lungs and he was diagnosed with miliary tuberculosis. Patient 2, a 54-year-old man with rheumatoid arthritis, received methotrexate, celecoxib and infliximab. The therapy regimen of infliximab was the same as the patient 1. The patient presented with cough and expectoration one month after the second infusion. A chest CT scan showed inflammatory changes in his lungs. The T-cell interferon-gamma release assays were positive. The possibility of pulmonary tuberculosis was considered. Both of the patients improved after treatment with anti-tuberculosis drugs.
  • 论著
    FANG Fang;LIU Min;CAI Hao-dong;CAO Yan-jun
    . 2012, 14(2): 73-4.

    ObjectiveTo explore the safety of lamivudine (LAM), telbivudine (LdT), and tenofovir (TDF) used in patients in early pregnancy. Methods The chronic hepatitis B patients taking LAM, LdT, and TDF in early pregnancy in Beijing Ditan Hospital from January 1, 2007 to December 31, 2011 were selected as subjects. All subjects were divided into the LAM group, the LdT group, and the TDF group. The situation that embryo stopped growing, spontaneous abortion,and ectopic pregnancy was monitored. The rate of pregnancy failure was calculated and its reason was analyzed. The rates of pregnancy failure were compared with those reported in past papers in the non-HBV affected mothers and HBV affected mothers in early pregnancy. ResultsOf the 92 patients in the LAM group, 11(11.6%) failed in the 95 pregnancies. Of the 60 patients in the LdT group, 6(9.5%) failed in the 62 pregnancies. Of the 11 patients in the TDF group, 1(9.7%) failed in the 12 pregnancies. There is no statistically significant difference in the rate of pregnancy failure among the 3 groups (P=0.923). The rates of pregnancy failure were not higher than those reported in past papers in the non-HBV affected (11%~16%) and HBV affected mothers (16.7%~21.9%). All pregnancy failure patients were suffered from diseases that were not related to chronic hepatitis B. ConclusionExposure to LAM, LdT, and TDF in early pregnancy is relatively safe to patients with chronic hepatitis B and no increase in the rate of pregnancy failure.

  • 病例报告
    A Li Mujiang;Deng Xiaoyan
    . 2011, 13(2): 128-2.
    A 57yearold man with acute myocardial infarction underwent coronary artery stenting. After the surgery, he was given aspirin 100 mg once daily, clopodigrel 75 mg once daily, and simvastatin 40 mg once daily at bedtime. On day 5, he developed aching pain in his right lower limb. On day 8, his creatine kinase was 2085 U/L and serum creatine was 187 μmol/L. Meanwhile he experienced dark urine and occult blood (+). Simvastatin was withdrawn, aspirin and clopodigrel were continued, and coenzyme Q10 was administered. On day 2 of drug discontinuation, his aching pain in his right lower limb improved markedly and creatine kinase level was 1337 U/L. On day 11 of drug discontinuation, his creatine kinase level decreased to 186 U/L and his serum creatine level was 101 μmol/L, and then he was discharged.
  • 论著
    XIANG Zheng;ZHANG Jian-feng;HE Fan;LI De-wei;XIAO Hang;DOU De-qiang
    . 2012, 14(1): 15-5.

    ObjectiveTo explore the function of half hemolytic dose(HD50) detection in alerting hemolytic adverse drug reactions caused by Xuesaitong injections and analyze the cause of abnormal hemolysis. Methods The red cell suspension (volume fraction 1.1%) was prepared with blood taken from the ear edge vein of rabbits and physiological saline solution. The red cell suspension was added into the different concentrations of Xuesaitong injections produced by different pharmaceutical factories and their hemolytic degrees were detected using spectrophotometry. Curve relationship between concentrations and hemolytic degrees were performed using Sigmaplot 10.0 software and half hemolytic dosage was calculated. Full wavelength scanning for hemoglobin in the red cell suspension of rabbit which had been added Xuesaitong injections, gallic acid or tannic acid was conducted and the changes of maximum absorbance wavelength were analyzed. The contents of phenols and tannin in the Xuesaitong injections were measured according to the method described in Chinese pharmacopeia. ResultsNormal (red blood cells ruptured and the supernatant changed into red) and abnormal hemolysis (the supernatant changed from red to brown or reddish brown) caused by Xuesaitong injections could be observed by naked eyes. The differences of HD50 were marked among injections produced in the different pharmaceutical factories and even among different batch numbers of the same pharmaceutical factory. The highest HD50 value was about 60 times of the lowest one. The characteristic absorption peak of hemoglobin disappeared in the scan spectra after the red cells suspension of rabbit were added into gallic acid, tannic acid or some Xuesaitong injections, suggesting that the abnormal hemolysis induced by some Xuesaitong injections were similar to that induced by tannin. The contents of phenols and tannin were higher relatively in the Xuesaitong injections with stronger hemolytic ability. ConclusionHD50 detecting could reflect the hemolytic activity of traditional Chinese medicine injections and alert the abnormal hemolysis induced by them. The abnormal hemolysis may be related to the higher contents of phenols and tannin in the traditional Chinese medicine injections.

  • 病例报告
    . 2001, 3(1): 29-29.
  • 病例报道
    . 1999, 1(1): 52-52.
  • 安全信息
    . 2009, 11(2): 146-2.
  • Chen Lu, Xu Lei
    Adverse Drug Reactions Journal. 2023, 25(4): 211-217. https://doi.org/10.3760/cma.j.cn114015-20220714-00632
    Objective To investigate the occurrence and clinical characteristics of immune-related adverse events (irAEs) caused by pembrolizumab (PEM) in elderly patients with advanced lung cancer. Methods The subjects were selected from the elderly patients with advanced lung cancer who received PEM therapy (200-mg was given by intravenous infusion once every 21 days and 21 days was a cycle) in the Affiliated Hospital of Inner Mongolia Medical University from August 2020 to July 2022. The medical records of patients meeting the inclusion criteria were collected through the Hospital Electronic Medical Record Information System, the clinical data such as patients′ basic information, pathological type of lung cancer, clinical stage, whether or not combination with chemotherapy, the occurrence time of irAEs, clinical manifestations, intervention, and prognosis were recorded and analyzed retrospectively. The irAEs were graded according to the Common Terminology Criteria for Adverse Event (CTCAE) Version 5.0 developed by the National Cancer Institute of the United States. Results A total of 100 patients were enrolled in the analysis, of which 22 (22%) patients developed irAEs. Among the 22 patients, 19 were male and 3 were female, aged from 61 to 90 years, including 15 lung squamous cell carcinomas and 7 lung adenocarcinomas. There were 4 patients with clinical stage Ⅲ and 18 patients with stage Ⅳ; one patient received PEM monotherapy and 21 patients received PEM combined with chemotherapy. A total of 28 cases of irAEs occurred in 22 patients (19 cases of 1 type of irAE, 1 case of 2, 3, and 4 types of irAE each), including 10 cases of skin irAEs (3 in grade 1, 3 in grade 2, and 4 in grade 3), 8 cases of immune-related pneumonitis (1 in grade 1, 7 in grade 2), 7 cases of irAEs involving the endocrine system (1 case of hypothyroidism in grade 1, 3 cases of hypothyroi- dism in grade 2, 1 case of adrenocortical dysfunction in grade 1, 1 case of hyperglycemia in grade 1, and 1 case of pituitary inflammation in grade 4), 2 cases of immune-associated hepatitis (1 in grade 1, 1 in grade 3), 1 case of ICI-related myocarditis in grade 3. The shortest occurrence time of the 28 cases of irAEs was on the day of initial medication, the longest was 20 days after the 17th cycle of medication, and 22 cases occurred between the 1st to 8th cycles of medication. After the occurrence of irAEs, 5 patients discontinued PEM and most received hormone and/or symptomatic treatment. Twenty patients were cured or self-healed, 1 partially recovered, and 1 was not improved. Conclusions Elderly patients with advanced lung cancer who receive PEM may experience skin, lung, endocrine system, liver, and heart irAEs, mostly occurring between the 1st to 8th cycles of medication, mostly in grades 1 and 2. Discontinuation of medication and hormone and/or symptomatic treatment can lead to a better prognosis.
  • Wang Quan, Zhou Guangjie, Li Jinfeng
    Adverse Drug Reactions Journal. 2022, 24(11): 604-606. https://doi.org/10.3760/cma.j.cn114015-20220211-00114
    A 79-year-old male patient with small cell lung cancer (extensive stage) received EC chemotherapy regimen (IV infusions of etoposide 0.1 g on day 1 to 3 and carboplatin 400-mg on day 1) combined with immunotherapy (IV infusion of duvalizumab 620-mg on day 1), and 21 days was a cycle. On the 16th day of the 3rd cycle (the 58th day after the first medication), the patient developed left limb tremor and epilepsy. Biochemical examination of cerebrospinal fluid showed total protein 642-mg/L, white blood cell count 10×106/L. Electroencephalogram showed a small amount of sharp waves in bilateral lower temporal lobe. Immune-related encephalitis due to durvalumab was considered. Durvalumab was discon- tinued, glucocorticoid was given to suppress immune responses, and levetiracetam was given for antiepileptic treatment. Thirty-five days later, no obvious tremor appeared in the left limb and no seizure recurred.
  • Wang Quan, Yan Xiujuan, Li Jinfeng
    Adverse Drug Reactions Journal. 2022, 24(8): 446-448. https://doi.org/10.3760/cma.j.cn114015-20220119-00049
    A 72-year-old male patient was treated with first-line chemotherapy and radiotherapy because of limited-stage small cell lung cancer. The tumor condition was stable in the evaluation of therapeutic effect. Later he received camrelizumab 200 mg alone by IV infusion once every 3 weeks.. On day 3 of the 2nd treatment cycle, the patient developed an acute binocular horizontal diplopia. Cerebral magnetic resonance examination showed no evidence of cerebral metastasis, stroke, traumatic brain injury, and meningitis, and other eye diseases were excluded by ophthalmic examination. Immune-related isolated abducens nerve palsy induced by camrelizumab was considered. The drug was stopped and intravenous infusion of methylprednisolone sodium succinate 30-mg once daily was given. One week later, the patient′s diplopic symptom was improved significantly. Prednisolone acetate tablets were given orally and the dose was gradually reduced. One month later, diplopia disappeared and did not recur at one month of follow-up.
  • 实验论著
    Jia Zhenrong;;Qiu Yinsheng;Wang Daju;Wang Cheng
    . 2009, 11(2): 91-5.
    Objective: To study the toxic effects of zidovudin on rat hepatocytes in primary culture. Methods: The hepatocytes were isolated from Wistar rats with a twostep perfusion technique and the hepatocellular viability were tested with trypan blue exclusion. The hepatocytes which had more than 85% viability were used in the experiment. The experiment was divided into four groups as follows: the medication group, the positive control group, the negative control group, and the blank control group. The hepatocyte suspension (3×105 cells/ml) were inoculated into culture plates: 200 μl was inoculated into each well of 96 well culture plates, 1ml was inoculated into each well of 24 well culture plates, 2.5 ml was inoculated into each well of 6 well culture plates. The hepatocytes were cultured in the incubator with 5% carbon dioxide at 37℃ for 4 hours, then the supernate was discarded. The hepatocytes were exposed to zidovudine 10, 5, 3.3, 2, 0.4, and 0.08 mmol/L in the medication group, carbon tetrachloride 10, 2, and 0.5 mmol/L in the positive control group, 1% DMSOcontaining DMEM in the negative control group, and DMEM in the blank control group. The activity of hepatocytes in the 96 well plates were measured with MTT experiment 6, 12, and 24 hours after exposure. The amounts of AST, ALT, and LDH release from hepatocytes in the 24 well plates were measured 6 and 12 hours after exposure. The hepatocytes in 6 well plates were stained with HE, and morphological changes were observed 12 hours after exposure. Results:The optical density (OD)to zidovudine (3.3 mmol/L) and carbon tetrachloride (2 mmol/L) 6, 12, and 24 hours after exposure was (1.20±0.17) versus (0.99±0.08), (0.89±0.09) versus (1.20±0.13), and (1.01±0.09) versus (0.88±013), respectively. The OD in the negative control group was (1.34±0.08), (1.11±0.10), and (1.03±0.11), respectively, at the same time points. The hepatocyte activity in the zidovudine and carbon tetrachloride groups, compared with the negative control group, markedly decreased. The difference was statistically significant (all P<0.05). The effect of zidovudine 10 mmol/L on hepatocyte activity was lower than that of carbon tetrachloride 10 mmol/L. Six and twelve hours after exposure to zidovudine 3.3 mmol/L, the amounts of AST release were (1853±2.02) KarU and (26.86±2.61) KarU, the amounts of ALT release were (15.16±218) KarU and (27.48±2.27) KarU,and the amounts of LDH release were(1 681.00±193.98) U/L and (2 708.55±78.73) U/L, respectively. In the negative control group, the amounts of AST release were (15.91±1.62) KarU and (37.71±2.54) KarU,the amounts of ALT release (1966±0.74) KarU and (23.42±1.46) KarU,and the amounts of LDH release were(2 036.39±134.56) U/L and (2 870.21±87.73) U/L, respectively, at the same time points. Compared with the negative control group, zidovudine could significantly effect the amounts of AST, ALT, and LDH release. The difference were statistically significant (all P<0.05). The membrance rupture and karyopknosis of hepatocytes were occurred after exposure to zidovudine ≥3.3 mmol/L. And after exposure to carbon tetrachloride 10 mmol/L, the hepatocytes become smaller, and the membrance rupture and karyopyknosis of hepatocytes occurred. Conclusion: Zidovudine ≥3.3 mmol/L has hepatocellular toxicity, but its toxicity is less than carbon tetrachloride.
  • 病例报告
    Chen Guoqing
    . 2009, 11(1): 59-1.
    A 52yearold woman with calculous cholecystitis received an IV infusion of enoxacin glyconate 0.2 g twice daily. She had no history of diabetes mellitus. Her blood glucose level was normal before therapy,but it was elevated on day 2 of therapy. Despite treatment with insulin, there were no good results. Her blood glucose level fluctuated between 10.20~11.20 mmol/L. Enoxacin glyconate was discontinued and other medications remained unchanged. Her blood glucose level normalized gradually.
  • 滥用误用
    He Ming
    . 2008, 10(2): 127-1.

    A 33yearold man with suspected urinary infection developed a dyspnea,coma,and undetectable blood pressure immediately after intramuscular injection of 2 ml of fibrauretin. Four hours after resuscitation attempts, he recovered. The patient often took fibrauretin tablets, but he did not experience anaphylaxis. However, he had experienced mild anaphylactic reactions from fibrauretin injection four years before.

  • Li Lihua;Zhao Yilei;Wu Xingfan
    Adverse Drug Reactions Journal. 2009, 11(4): 284-2.
    A 45yearold woman with hypertension received lacidipine 4 mg and nifedipine controlledrelease tablets. Eight hours later, the patient presented with flushing, pruritus, and urticaria on her limbs and trunk. An examination showed a temperature of 38.2℃, facial, lip and eyelid oedema. Laboratory tests revealed the following values: WBC count 8.0×109/L, N 0.708, L 0.246, E 0.58. Symptomatic treatment was given. One week later, rash and oedema subsided. Subsequently, the drugs were changed to amlodipine and nifedipine controlled-release tablets, and no allergic reaction recurred.
  • 病例报告
    Pi Ying;Zhang Nianwei
    . 2008, 10(4): 0-0.

    A 64yearold man was hospitalized with hypertension and chronic renal failure complicated by superficial abscess of left ankle. The man was infused with cefazolin sodium pentahydrate 2 g dissolved in 100 ml of sodium chloride injection 0.9% every 12 hours intravenously for treating infection. Three days later, the man developed mental disorder, consciousness disturbance and convulsion. Water and electrolyte disturbances, uremic encephalopathy, cerebrovascular accident and viral encephalitis were excluded by CT examination and blood biochemical analysis. Cefazolin sodium pentahydrate was stopped and other medications were unchanged. The patient’s encephalopathic symptoms resolved gradually.

  • 国外文献题录
    . 2002, 4(4): 273-274.
  • 实验论著
    Kong Yi;Sun Yabin;Li Guofeng;Duan Lian;Chen Yehao
    . 2010, 12(5): 313-4.
    Objective: To observe the effects of compound Huanggan granules (CHG) on the intestinal mucosa transport of a P-glycoprotein substrate rhodamine 123 (R123) and a non-P-glycoprotein substrate 6-carboxyfluorescein(CF)in order to provide the evidence of rational use of the combination of CHG and a Pglycoprotein substrate drug. Methods: Twenty SPF SD male rats, weighing(250±20)g, were divided into the normal saline(NS) group and the CHG group by randomdigit table method (n=10, in each group). The rats in the NS and CHG groups were gavaged with normal saline solution (20 mL/kg) and 1.0 g/L CHG solution (20 mL/kg) twice daily for 7 days, respectively. One week later, the rats were fasted for 16-18 hours and anesthetized with 10% chloral hydrate(3 mL/kg, IP), and a 3-4 cm segment of jejunum of each rat was obtained. The effects of rat jejunum mucosa in both groups on the permeability of R123 and CF were measured by ussing chamber method in vitro.The apparent permeability coefficient (Papp) of absorptive (mucosal to serosal) and secretary (serosal to mucosal) transport direction of R123 and CF as well as the efflux ratios(ER) were compared between the two groups. Results: The Papp of R123 in the absorptive direction in the NS and CHG groups was (3.54±0.86) ×10-6 cm/s and (2.39±0.44)×10-6 cm/s, respectively,and the Papp of R123 in the secretory direction was (8.68±3.76)×10-6 cm/s and(8.34±2.47)×10-6 cm/s, respectively. The Papp of CF in the absorptive direction in the NS and CHG groups was (5.40±3.20)×10-6 cm/s and (3.28±1.41)×10-6 cm/s, respectively, and the Papp of CF in the secretory direction was (5.09±1.71)×10-6 cm/s and(3.98±1.02)×10-6 cm/s, respectively. There was no statistically significant difference (all P>0.05). The ER of R123 and CF in the NS group were 2.45 and 0.94, the ER of R123 and CF in the CHG group were 3.50 and 1.21, respectively. Conclusion: The compound Huanggan granules have no marked effect on Pglycoprotein activity in the intestinal mucosa. It is suggested that the combination therapy with CHG and a Pglycoprotein substrate drug which is similar to rhodamine 123 is relatively safe.
  • 病例报告
    Fan Chun;Wang Ying
    . 2010, 12(4): 282-3.
    A 73yearold man with atrial fibrilation received IV infusions of amiodarone 800 mg/d for one week, and then 600 mg/d for one month, 400 mg/d for two months, and 200 mg/d for three months by mouth. After six months, the patient developed dry cough and shortness of breath. CT scan revealed pulmonary interstitial fibrosis in both lungs. Laboratory tests revealed the following levels and values: WBC 22.68×109/L, N 0.76; BUN 11.20 mmol/L, SCr 182 μmol/L; blood pH 7.36; PO2 35 mm Hg, PCO2 49 mm Hg and SaO2 64%. Amiodaronerelated pulmonary interstitial fibrosis with infections was considered.The patient was given oxygen inhalation through a face mask, an IV infusion of levofloxacin 0.5 g once daily, an IV infusion of cefoperazonesulbactam 3.0g twice daily, an IV infusion of methylprednisolone 40 mg twice daily, and acetylcysteine 0.6 g twice daily. On the day 14 of therapy, the man had a severe decrease in pulmonary diffusion capacity, severe hypoxemia ( SaO2 < 50%), a BUN level of 18.90 mmol/L, a SCr level of 286 μmol/L, and a urine volume of 200 mL/d. On day 21 of hospitalization, his BUN was 24.10 mmol/L and his SCr was 357 μmol/L. The patient's blood pressure decreased markedly with frequent episodes of atrial fibrillation. Finally, the patient died of failure and pulmonary infections.
  • 病例报告
    CHEN Wen-ju;YANG Qiang-qiang;FANG Hui-juan;DONG Yuan-yuan;SU Ye-feng;WANG Ying-ying;CUI Xin-gang
    . 2012, 14(6): 394-3.
    A 34-year-old women self-medicated with 3% acyclovir ointment application and an IV infusion of acyclovir 0.25 g in 0.9% sodium chloride 100 ml for herpes zoster. About 2 minutes after the start of infusion, the patient developed lip numbness, chest distress, dizziness and asthenia. Acyclovir was stopped, and she presented to a hospital emergency department and was treated with oxygen inhalation. Soon afterwards, she developed the erythema on her skin of head and face, chest and proximal limb, as well as lip cyanosis and swelling. About 8 minutes after acyclovir infusion stopped, she had blurred vision, and her blood pressure decreased to 70/40 mm Hg. About 13 minutes later, she presented with amaurosis, nausea and vomiting. She was treated with IV dexamethasone, IV adrenaline, and an IV infusion of hydrocortisone, followed by dopamine and norepinephrine via a pump. After 14 hours, the allergic symptoms disappeared completely.
  • ZENG Qian;XIE Xue-yuan;LIU Ping;LI Xiao-hui
    . 2013, 15(5): 282-2.
    A 52-years-old female patient with breast cancer received chemotherapy regimen(epirubicin and cyclophosphamide for 4 cycles followed by docetaxel for another 4 cycles)after operation. She experienced diarrhea with watery stool around 10 days after each treatment cycle of docetaxel, was treated with montmorillonite powder and her diarrhea disappeared. A chest CT scan revealed no abnormal finding before sequential chemotherapy with docetaxel, while effusion in both lungs after docetaxel chemotherapy. Two months later, effusion in both lungs disappeared.
  • Li Xuewena;Gu Xinb;Meng Fanchaoa;Zong Jieb;Cui Lanzhub;Lu Gangb;Huang Liangshengc
    Adverse Drug Reactions Journal. 2010, 12(1): 61-2.
    A 52yearold man underwent a CTA test. After an IV bolus injection of iohexol 20 ml, his heart rate increased from 65 beats/min to 90 beats/min and he developed throat discomfort, cough, and skin itching on hands. Then iohexol was withdrawn. Subsequently, the patient experienced generalized asthenia, faint, confusion, weak pulse, and polyhidrosis, her blood pressure was undetectable. Antiallergic, antishock, and symptomatic treatments were given immediately, his symptoms improved gradually. He recovered after one week.
  • Huang Banghua;Hong Min;Pu Yanfang
    Adverse Drug Reactions Journal. 2010, 12(2): 142-2.
    A 40yearold man with pericoronitis accompanied by spaces infections received an IV infusion of cefoxintin sodium 2 g in 5% glucose 100 ml. About 5 minutes after cefoxitin sodium infusion start, the patient experienced numb tongue and peripheral extremities, dizziness, abdominal colic with an urge to defecate. Physical examination revealed weak pulses, muffled heart sounds, mild lip cyanosis, and cold peripheral extremities. His heart rate was 110 beats/min and blood pressure was undetectable. Adrenaline, dexamethasone, and methylprednisolone were given. One hour later, his symptoms improved.
    KEY WORDS
  • 病例报告
    Lv Feijuan;Yang Yanling;Yang Daichun
    . 2010, 12(2): 129-2.
    A 25-year-old man with hypokalemic periodic paralysis received telbivudine 600 mg/d once daily for chronic viral hepatitis B. After 10 months of treatment, the patient developed nausea, vomiting, generalised aching pain, decreased urinary output, and dark urine. Telbivudine was discontinued and switched to lamivudine. Symptomactic and supportive treatments were given. His aching pain in lower limbs was still marked and he was hospitalized. Rhabdomyolysis, metabolic acidosis, and chronic viral hepatitis B were diagnosed. Lamivudine was stopped. Meanwhile he received symptomatic and supportive therapies. His symptoms aggravated and, on day 9 of admission, he died from respiratory and circulatory failure.
  • Huang Xiaojing, Gao Naijun, Huang Lin, Gu Qun, Feng Wanyu
    . 2017, 19(3): 226.
    A 19-day-old female neonate was treated with an IV infusion of meropenem 26 mg every 8 hours for neonatal clinical sepsis. Before the treatment, the newborn′s neutrophil count (NEUT) was 1.0×109/L. On day 3 of administration of meropenem, the NEUT was 1.0×109/L. On day 4, meropenem dosage was increased to 52 mg every 8 hours to strengthen the anti-infective therapy. On day 8, the NEUT was 0.9×109/L. On day 16, the NEUT declined to 0.3×109/L. On day 20, her infection was under control, and meropenem was withdrawn. The results of reexamination 3 days later showed NEUT 3.3×109/L.
  • Ma Xiaoyan, Cai Haodong
    . 2015, 17(3): 235.
    A 69-year-old patient with hepatitis B cirrhosis to join clinical trials of antiviral therapy. His baseline serum creatinine level was 89 μmol/L and creatinine clearance was 56 ml/min. He was given oral lamivudine 100 mg daily. His serum creatinine level was 91 μmol/L and creatinine clearance was 54 ml/min 48 weeks later. Adefovir dipivoxil 10 mg daily was added to the regimen. Three years later, the patient′ s serum creatinine level increased to 113 μmol/L and creatinine clearance was 39 ml/min. He was considered as renal insufficiency due to adefovir dipivoxil. The dosage of adefovir dipivoxil was reduced to 10 mg once every other day and lamivudine was continued according to the original dose. Six months later, the patient′ s serum creatinine level was 88 μmol/L and the creatinine clearance was 50 ml/min.
  • Bao Chunrong, Yu Zicheng
    . 2015, 17(4): 287.
    Ritodrine hydrochloride, a beta 2 adrenergic receptor agonist, is used for prevention of preterm birth. Maternal cardiac arrhythmias, pulmonary edema, rhabdomyolysis, parotitis, granulocytopenia, acute generalized exanthematous pustulosis, nausea, vomiting, and elevated blood glucose are the main adverse reactions induced by ritodrine hydrochloride in the pregnant woman. The possible mechanisms of the above-mentioned adverse reactions may be associated with ritodrine hydrochloride inducing electrolyte imbalance, hypokalemia, changes of pulmonary capillary wedge pressure, muscular transient ischemia due to hypokalemia, hypersecretion of salivary amylase, bone marrow suppression, and promoting of glycogenolysis. The mechanism of acute generalized exanthematous pustulosis induced by ritodrine hydrochloride is yet unknown. Fetal over growth, fetal tachycardia, and neonates transient neutrophil reduction may be the main adverse reactions induced by ritodrine hydrochloride in the fetuses. The possible mechanisms may be associated with fetal insulin hypersecretion which is due to maternal hyperglycemia induced by ritodrine hydrochloride, immune-mediated toxic reactions through placental barrier, as well as changes in placental blood flow. The maternal heart rate, blood glucose, routine blood tests, liver and kidney function should be checked regularly when the pregnant woman is receiving ritodrine hydrochloride. Once the adverse reactions occured, ritodrine hydrochloride should be discontinued and the symptomatic treatment should be given. In infants whose mother received ritodrine hydrochloride, cardiac function should be evaluated by echocardiography when necessary,  blood glucose should be checked, and breast-feeding or formula feeding should be started as early as possible.
  • a Xiaolei, Zhang Lanyue, Wang Ran, Feng Xin
    . 2015, 17(6): 459-460.
    A 30-year-old female patient with uterine fibroids and endometriosis received subcutaneous injection of leuprorelin acetate microspheres sustained release 3.75 mg. One week later, the patient developed weakness, tired of greasy foods, decreased food intake, and occasional nausea. Laboratory tests revealed the following results: alanine transaminase (ALT) 1 108 U/L, aspartate transaminase (AST) 612 U/L, total bilirubin (TBil) 141 μmol/L, direct bilirubin (DBil) 115 μmol/L, albumin 43 g/L, gamma glutamyltranspeptidase (γ-GT) 188 U/L, urine bilirubin ++. The patient was considered as liver injury induced by leuprorelin acetate microspheres sustained release for injection. She received symptomatic treatments which included hepatoprotective, jaundice-relieving and cholestasis-lessening regimens. Thirty days later, the laboratory tests showed ALT 5 U/L, AST 17 U/L, TBil 27 μmol/L, DBil 11 μmol/L, γ-GT 107 U/L, and urine bilirubin negative.
  • 病例报告
    Wang Jiesong*;Zhang Chaoli;Fei Jun;Xie Yajun;Guan Xiaochan;Wu Jiuhong
    . 2014, 16(6): 379-2.
    A 63-year-old female patient underwent coronary CT angiography and received an intravenous iohexol injection (350 mg/ml ) 80 ml as the contrast agent. At the sixth minutes of observation after CT test completion, the patient developed palm itching, bilateral conjunctival congestion and edema, sweating, vertigo, nausea, and vomiting a small amount of gastric contents and then followed by lip cyanosis, facial edema, cold limbs, skin ecchymosis, and bleeding the injection site. Blood gas analysis showed an oxygen saturation of 0.83 and an oxygen partial pressure of 47 mmHg. About an hour after CT scan, the laboratory test revealed the following levels: blood platelet count 19×109/L, prothrombin time (PT) 18 s, and thrombin time (TT) 6 s. Treatments with anti-anaphylaxis, coagulation factor supplementation, and correction of acidosis and electrolyte disorder were given. After 7.5 hours after CT scan, her blood platelet count was 8×109/L. The next day, large pieces of skin ecchymosis appeared in many parts of her body, a body temperature reached 38.1 ℃ and a blood platelet count was 6×109/L. Symptomatic and supportive therapy was continued and her condition gradually improved. On day 4, she presented with normal temperature, disappeared facial edema, and relief of skin ecchymosis. On day 6, her level of blood platelet and all the values of coagulation functions returned to normal.
  • 用药错误
    Chen Weibi;Gao Lehong
    . 2014, 16(6): 381-2.
    A 67-year-old woman was given furazolidone 0.6 g daily for gastritis. About one month after drug use, the patient developed rashes and itching on many parts of her body. About 40 days after drug use, symmetric numbness appeared in the area of her limbs and progressed to appear around the mouth as well as in tongue. About 50 days after drug use, she experienced dizziness and unstable walking accompanied gradually by hyperaction, a few of visual and auditory hallucination, and occasional involuntary shaking of her both upper extremities. About 60 days after drug use, the patient had taken furazolidone 36 g in total and stopped the drug. Electromyography test showed peripheral neurogenic damage. She was given an intravenous infusion of dexamethasone, thioctic acid, ganglioside, and compound coenzyme combined with intramuscular vitamin B1 and mecobalamine. On day 14 of therapy, her mental state and walking normalized, dizziness and numbness around the mouth and of tongue improved remarkably. At follow up after half a year, the patient had only light numbness in the acra of her limbs and skin pigmentation and others returned to normal.
  • 病例报告
    . 2000, 2(1): 56-56.
  • 病例报告
    . 2000, 2(1): 54-54.
  • 病例报告
    ZHANG Rui-li;MEI Na;XIA Kun;LI Guo-hui
    . 2013, 15(1): 51-2.
    A 68-year-old men received an IV infusion of moxifloxacin 400 mg once daily for severe pneumonia occurring after undergoing a surgery for lung cancer. On the fourth night, he developed involuntary soliloquy. A review of his medical history revealed that he had experienced similar symptoms with an abnormal expression on his face 3 days after starting levofloxacin treatment and had recovered after drug withdrawal. Moxifloxacin was withdrawn and changed to an IV infusion of etimicin 0.2 g twice daily. Four days later, his symptom of soliloquy disappeared and did not recur before he was discharged.
  • 病例报告
    Li Yingran;Lu Rongzhi
    . 2011, 13(4): 243-2.

    Four very-low-birthweight premature infants (a pair of female twins, gestational age 31 weeks; a pair of male twins, gestational age 29 weeks.) received linezolid 10 mg/kg every 8 hours via an IV pump for anti-infective treatment 22-31 days after birth. Patients 1 and 2 were given linezolid alone. Patient 3 was prescribed combination therapy with linezolid, meropenem, and amphotericin B liposome. Patient 4 was administered concomitant use of linezolid and amphotericin B liposome. On days 4, 16, 8, and 10 after drug administration, they all experienced thrombocytopenia and the minimum platelet count was 27×109/L, 74×109/L, 23×109/L, 4×109/L, respectively. Six to seventeen days after linezolid withdrawl and administration of symptomatic treatment, their platelet count returned to normal.

  • 不良事件
    . 2005, 7(3): 227-227.
  • 国外信息
    . 2005, 7(1): 72-73.
  • WHO信息
    . 2003, 5(3): 207-207.
  • 病例报告
    . 2003, 5(1): 47-47.
  • 病例报告
    . 2005, 7(5): 369-370.
  • 病例报告
    Xiang Pan;Wang Fang;Wang Yu;Li Ping
    . 2009, 11(1): 64-1.
    A 73yearold man, who had 20 years or more history of hypertension, was treated with oral sustainedrelease nifedipine, furosemide, spironolactone, and aspirin. Subsequently captopril 12.5mg thrice daily was added to his regimen due to elevated blood pressure. After 3 days of therapy, he developed spitting up water on drinking, eating difficulties with cough and nausea. A gastroscopy showed marked edema of epiglottis. Captopril was withdrawn and his remaining medications were continued. Two days later, his drinking and eating normalized; his cough improved.
  • 临床论著
    Li Xia;Ye Hong;Su Yingying
    . 2009, 11(4): 229-4.
    Objective: To observe adverse reactions of antishivering drugs used for patients with acute ischemic stroke during hypothermia therapy. Methods: Between 1 November 2005 and 30 August 2007, 15 patient who had acute ischemic stroke with an onset time within 3 days received hypothermia therapy. The patients comprised 10 men and 5 women with mean age (57±1) years. Of the 15 patients, 10 received surface cooling and 5 received endovascular cooling. All patients received antishivering drugs before hypothermia therapy. The patients receiving surface cooling were administered with an IV push of a loading dose of chlorpromazine 25 mg and a loading dose of promethazine 25 mg, followed by a continuous infusion pump delivering 15 mg/h of chlorpromazine and promethazine, and then their dosage was adjusted according to the grade of shivering. The patients, who received endovascular cooling and was not in a coma, were administered with an IV push of a loading dose of pethidine 1 mg/kg and a loading dose of promethazine 25 mg, followed by a continuous infusion pump delivering pethidine 2535 mg/h and promethazine 1.53 mg/h; when patients developed grade 1 shivering, an IV push of pethidine 1025 mg was given again, followed by a continuous infusion pump delivering pathidine 5 mg/L until the shivering was controlled. The patients, who received endovascular cooling and was in a coma, was administered with an IV infusion of a loading dose of atracurium 0.4 mg/kg, followed by a continuous infusion pump delivering 5 μg/(kg·min); the maximum dose was 45 mg/h. Results: Adverse reactions occurred in 7 of 15 patients (46.7%). Of the 10 patients receiving surface cooling, 4 developed adverse reactions including 2 cases of rapid atrial fibrillation (154 beats/min and 157 beats/min) and 2 cases of decreased blood pressure (from 171/82 mm Hg to 97/50 mm Hg and from 192/109 mmHg to 113/87 mm Hg). Of the 5 patients receiving endovascular cooling, 3 presented with adverse reactions including 1 case of decreased respiratory rate (8 breaths/min) and 1 case of decreased respiratory rate with decreased heart rate (77 beats/min) and decreased blood pressure (88/39 mm Hg), 1 case of decreased blood pressure (57/39 mm Hg). Of the 7 patients who experienced adverse reactions, 5 recovered after symptomatic treatment and 2 did not complete their hypothermia therapy due to rapid atrial fibrillation. Conclusion: Adverse reactions of antishivering drugs are mainly heart rate change and decreased blood pressure; most of them are mild and do not affect the hypothermia therapy.
  • Zhang Xuguang
    Adverse Drug Reactions Journal. 2010, 12(1): 54-2.
    A 64yearold man received aspirin 300 mg once daily and clopidogrel 75 mg once daily and an IV infusion of urokinase 1.5 million units. Meanwhile he was treated with isosorbide dinitrate, metoprolol, and lovastatin. One month later, aspirin was reduced to 100 mg once daily while clopidogrel was maintained at constant dose. Seven months later, the patient developed fever and sore throat. Routine blood tests revealed the following levels: WBC count 1.6×109/L, PLT count 82×109/L. Clopidogrel was withdrawn and other treatments remained unchanged. Seven days later, the levels of WBC and platelet returned to normal range. Aspirin, metoprolol, and lovastatin were continued and there was no recurrence of thrombocytopenia at one year of follow up.
  • 病例报告
    Zhou Xin;Liu Ruining;Li Hongjie
    . 2009, 11(3): 208-2.

    An 84-year-old woman was hospitalized with marked emaciation and anorexia. On admission, her liver function examination revealed the following values: ALT 10.0 U/L, AST 20.2 U/L, and γ-GT 16.3 U/L. An IV infusion of alany1 glutamine 20 g plus compound amino acid (18AA-Ⅱ) 500 ml was given. Three days later, her ALT level was 98.7 U/L, her AST level was 172.3 U/L, and her γ-GT level was 16.0 U/L. On day 5 after admission, the infusion was stopped; and on day 16, her liver function normalized. An IV infusion of alany1 glutamine plus compound amino acid (18AA-Ⅱ) was readministered. Four days after administration, her ALT and AST levels increased to 149.8 U/L and 129.5 U/L, respectively. The infusion was stopped again and her liver function normalized gradually.

  • 病例报告
    Wang Ping
    . 2009, 11(4): 279-2.
    Two patients with Parkinson's disease developed mental disorders after receiving levodopa and benserazide tablets (each tablet contains levodopa 200 mg and benserazide 50 mg).  Patient 1, a 70yearold woman, received an initial dose of a half levodopa and benserazide tablet once daily, then the dose was gradually increased to 3 tablets once daily. Eight months later, the patient developed repression and agitation. Subsequently, the dosage was increased to 4 tablets divided into 2 doses. After 3 weeks, she presented with confusion of consciousness, hallucination, and suicidal attempt. Therefore, the dosage was decreased to 3 tablets divided into 3 doses and her symptoms disappeared. Patient 2, a 65yearold woman, received 3 levadopa and benserazide tablets once daily. Two months later, she experienced insomnia, agitation, asthenia, repression. The dosage was decreased to 2 tables once daily. Her symptoms resolved one week later.
  • 中药不良反应
    . 2006, 8(5): 393-393.
  • 病例报告
    . 2006, 8(3): 213-213.
  • 安全用药
    . 2001, 3(3): 168-173.
    本文对老年特殊人群的安全用药进行分析,结合老年的生理功能、病理生理改变,对老年高血压、 老年心衰、老年心律失常及老年急性心肌梗死的合理、安全用药进行阐述。
  • 病例报告
    . 2006, 8(5): 376-377.
  • 临床论著
    Zhang Jianxin;Shang Lan
    . 2009, 11(3): 158-3.
    Objective: To observed the effects of risperidone on electrocardiogram (ECG) in drugnaive patients with firstepisode schizophrenia. Methods:Ninetyfive drugnaive inpatients with firstepisode schizophrenia between January 2004 and December 2008 were enrolled in the study. The patients comprised 40 men and 55 women with average age of (33.85±10.80)years. Seventytwo patients’age was < 40 years and 23 patients’age was 40-70 years. The disease duration was ≥5 years in 32 cases (33.68%) and <5 years in 63 cases (66.32%).The patients started receiving risperidone at an initial dose of 1 mg once daily that was gradually increased to 2-6 mg daily within 2 weeks for a total of 3 months; of them, 32 patients received lowdose risperidone (<4 mg/d) and 63 patients received high-dose risperidone (≥4 mg/d). The patients’ECG was performed before and 1, 2, and 3 months after administration. The relationship among sex, age, disease duration, dosage and ECG changes was observed. Results: Risperidone-induced abnormal ECG mainly was sinus arrhythmia including sinus tackycardia, sinus bradycardia, and sinus irregularity, and secondly was ST-T changes. Abnormal ECG occurred respectively in 37 cases (38.95%), 28 cases (29.47%), and 31 cases (32.63%) 1,2, and 3 months after administration. Of them, male and female patients were respectively 19 cases (47.5%), 14 cases (35.0%), 12 cases (30.0%) and 18 cases (32.7%), 14 cases (25.5%), 19 cases (345%); the patients with age of 4070 years and < 40 years were respectively 5 cases (21.7%), 5 cases (21.7%), 6 cases (26.1%) and 32 cases (44.4%), 23 cases (31.9%), 25 cases (34.7%); the patients with disease duration of ≥5 years and < 5 years were respectively 12 cases (37.5%), 9 cases (28.1%), 6 cases (18.8%) and 25 cases (39.7%), 19 cases (30.2%), 25 cases (39.7%); the patients receiving low-dose and highdose risperidone were respectively 8 cases (25.0%), 7 cases (21.9%), 8 cases (25.0%) and 29 cases (46.0%), 21 cases (33.3%), 23 cases (36.5%). There were no differences in ECG changes in different time points among the patients with different sex, age, disease duration, and doses(all P>0.05). Conclusion: The effects of risperidone on ECG in drugnaive patients with firstepisode schizophrenia are mild. It is a less cardiotoxic antipsychotic drug.
  • 药物误用
    Zhou Xiaolong;Liu Zhongchu;Zeng Yonglan
    . 2009, 11(2): 123-1.
    A 38yearold man received 1 levodopa and benserazide 125 mg tablet for Parkinson disease. Thirty minutes later, the patient developed shanking of his hands and muscle spasm in his extremities, which lasted for 1~2 hours. Levodopa and benserazide tablets were stopped, and trihexyphenidyl was given. The above symptoms were disappeared. A review of his medical history revealed that he had received levodopa and benserazide tablets and had developed the same symptoms mentioned above one year earlier.
  • Chen Zhaoxiaa;He Lianghongb
    Adverse Drug Reactions Journal. 2009, 11(5): 334-1.
    A 16-year-old boy with right ptosis received neostigmine testing. Before testing, his blood pressure was 96/60 mm Hg. An IM neostigmine 1 mg was given. Fourteen minutes later, the patient developed chest distress, short of breath, dyspnea, tic of limbs, pallor, cyanosis, and weak pulse. His blood pressure was 60/40 mm Hg. Oxygen inhalation, adrenaline, dexamethasone, and fluid supplementation were given immediately. Thirtyfive minutes later, his symptoms disappeared and blood pressure returned to within normal range.
  • Zhao Min;Zhang Xiuhong
    Adverse Drug Reactions Journal. 2010, 12(1): 58-2.
    Anaphylactic reactions appeared in two patients after administration of an IV infusion of rituximab. Patient 1, 61yearold women with nonHodgkin lymphoma, was hospitalized for chemotherapy. On day of admission, the patient received an IV infusion of rituximab 600 mg once daily. Two hours later, she developed throat discomfort followed by short of breath, chilliness, fever, shivers and her temperature was 37.8℃. Rituximab was withdrawn and an IV dexamethasone was given. Her symptoms relieved after two hours. About half an hour after restarting an IV infusion of rituximab, she experienced dysphyagia, short of breath, polyhydrosis with a BP of 80/52 mm Hg. Rituximab was stopped again and antiallergic therapy was given. Four hours later, her symptoms improved.Patient 2, 52yearold women with chronic lymphocytic leukemia, was treated with combined chemotherapy with fludarabine and rituximab. She received an IV infusion of rituximab 600 mg once daily. About half an hour later, the patient presented with chest distress, short of breath, tightened throat, lip cyanosis accompanied by chilliness, shivers, and diffuse wheezing in both lungs. Rituximab was discontinued and oxygen inhalation and antiallergic treatments were given. Two hours later, her symptoms relieved. On second day, she was administrated with combined chemotherapy with cyclophosphamide and fludarabine, the abovedescribed symptoms did not recur.
  • 病例报告
    . 2003, 5(1): 42-43.
  • 病例报告
    . 2006, 8(1): 54-54.
  • 病例报告
    . 2001, 3(4): 221-221.
  • 病例报告
    Xu Yamei;Kou Lanjun;Hang Haiyan
    . 2011, 13(5): 315-2.

    A 76-year-old woman received an IV infusion of cefoperazone sodium and sulbactam sodium 1.5 g thrice daily, IV Shengmai 40 ml, IV sulfotanshinone sodium 60 mg, and IV isosorbide mononitrate 10 mg for pulmonary infection and coronary heart disease. On day 4 of treatment, she developed coagulation disorders. Laboratory tests revealed a prothrombin time (PT) of 58.4 s, a prothrombin activity (PTA) of 13%, an international normalized ratio (INR) of 3.83, and a thromboplastin time (APTT) of 38.5 s. On day 5, sulfotanshinone sodium was discontinued. On day 7, her coagulation disorders aggravated, and laboratory tests showed the following levels: PT 105.8 s, PTA 5.8%, INR 7.02, APTT 49.7 s. On day 12, coagulation disorders was considered to be related to cefoperazone sodium and sulbactam sodium and then the drug was withdrawn, and other medicines were continued. She presented with gross hematuria and ecchymosis on her chin in the evening. On day 13, the patient developed hematemesis, and her APTT was 99.4 s. An IV infusion of fresh frozen plasma, IV carbazochrome sodium sulfonate, and IM vitamin K1 were given immediately. On day 15, repeat blood coagulation tests revealed the followed levels: PT 11.00 s, PTA 123.3 %, INR 1.048, APTT 30.10 s.

  • 病例报告
    WANG Ke-ke;JIANG Ming-yan;ZHU Peng-li;ZHANG Lin;LI Yan
    . 2013, 15(2): 113-2.
    A 24-year-old male patient with secondary hypertension received a therapeutic trial (diagnostic treatment) with spironolactone in order to exclude primary aldosteronism. He was given oral spironolactone 20 mg after lunch, after dinner and the next morning, respectively. About 3 hours after taking the first dose, the patient developed weakness of limbs, dizziness, and headache. The patient underwent bed rest and oxygen inhalation. About 30 minutes later, his symptoms relieved. Three hours after taking the second dose, he developed weakness. About two hours after taking the third dose, the above-mentioned symptoms recurred, accompanied by lethargy. The symptoms relieved spontaneously 2 hours later. Spironolactone was withdrawn. Five days later, the patient was retreated with oral spironolactone 20 mg after supper. Two hours after the drug use and the next morning, dizziness, hypodynamia, and lethargy recurred. Then, the symptoms relieved spontaneously
  • 病例报告
    WANG Min;CAI Hao-dong;GUO Li-zhu
    . 2012, 14(6): 373-3.

    A 57-year-old man with chronic hepatitis B received adefovir 10 mg daily orally. About three years after the start of the drug therapy, the patient developed bilateral lower limb swelling and pain in the morning and an elevation of serum alkaline phosphatase. After 4 years of the drug therapy, the patient was admitted to Xuanwu Hospital of Capital Medical University due to worsening pain in his lower limbs, and asthenia. Physical examination showed grade 4 muscle strength of the both lower limbs, weakened tendon reflexes, and hypalgesia in extremities. Laboratory test revealed a markedly reduced serum phosphate level of 0.59 mmol/L and electromyogram showed neurogenic injury. X-ray and ultrasonic examination showed osteoporosis. The patient was diagnosed with hypophosphatemic osteopathia and peripheral neuropathy related to adefovir. So adefovir was stopped and his therapy was changed to entecavir. The symptoms gradually improved. One month later, the serum phosphate level returned to normal (0.99 mmol/L) and, 3 months later, his bilateral lower limb pain disappeared completely, muscle strength was normal, and osteoporosis improved markedly.

  • 论著
    Lan Xi;Wang Shengfeng;Zhai Suodi;Ren Jingtian;Jiao Ligong
    . 2014, 16(3): 143-4.
    ObjectiveTo analyze risk signals of liver injuries related to nonsteroidal anti-inflammatory drugs (NSAID) and application of reporting odds ratio (ROR) in data mining.MethodsA search of adverse drug reaction(ADR) reports in Beijing of national monitoring system of adverse drug reaction from January 1st 2013 to December 31st 2013 was conducted using keywords "liver" and "gallbladder" . Of these filtered reports, the cases whose causal relationship of drugs and liver injuries was judged as "positive", "likely", or "possible" were enrolled into liver injury group and the rest cases were all enrolled into non-liver injury group. Using NSAID as the target drugs and the other drugs as non-target, ROR and its 95% confidence interval (CI) of liver injuries related to NSAID were calculated according to formula of ROR. The lower limit of 95% CI >1 was regarded as suggestive of ADR signal.ResultsAfter removing duplication, 14 657 patients were enrolled in the study, which comprised liver injury group 626 patients including 35 cases of liver injuries due to NSAID and non-liver injury group 14 031 patients. Of the 35 patients with liver injuries related to NSAID, 30 patients were associated with single-preparation NSAID and 6 patients were associated with compound-preparation. The ROR levels and their 95% CI of single-preparation NSAID, compound-preparation NSAID, and general NSAID were respectively 1.78 (1.22-2.61), 1.80(0.78-4.15), and 1.76 (1.24-2.51). Both of the lower limits of 95% CI of live injuries related to single-preparation NSAID and general NSAID were higher than 1 and there were ADR signals. Thirty-seven kinds of drugs were involved by 35 cases of liver injuries. Of them, the ROR levels and their 95% CI of single-preparation parecoxib, single-preparation aspirin, compound-preparation ibuprofen and pseudoephedrine, and compound-preparation parace-tamol and amantadine hydrochloride were respectively 8.00(2.03-27.78), 2.45(1.43-4.21), 22.00(1.40-359.32), and 11.22(1.02-123.94) and there were ADR signals.ConclusionsAttention should be paid to liver injuries related to NSAID. The method of ROR can help analyze ADR signals and provide useful early-warning of drug safety.
  • Cheng Jun
    . 2016, 18(3): 197.
    ObjectiveTo summarize the clinical characteristics of subacute cutaneous lupus erythematosus (SCLE) due to proton pump inhibitor (PPI).MethodsThe database of China National Knowledge Infrastructure, VIP, Wanfang and PubMed were searched. The reports in literature about SCLE related to PPI were collected. The patients′ sexuality, age, history of past illness, medications, the time from medication to appearance of SCLE symptoms, clinical characteristics of SCLE, results of laboratory examination, treatment and prognosis. The clinical characteristics of SCLE related to PPI were analyzed.ResultsA total of 10 cases were reported to have SCLE due to PPI overseas and 26 patients were enrolled in this study. They comprised 4 males (15.4%) and 22 females (84.6%) with the average age of (63±14) years. Of them, 23 cases (88.5%) were over 50 year-old, six patients had the history of autoimmune disease. All the patients received PPI orally. Twenty seven case-times of SCLE occurred. Of them, numbers of cases caused by lansoprazole, omeprazole, esomeprazole and pantoprazole were 9, 8, 5 and 5 case-times, respectively. The time from medication to appearance of SCLE symptoms were from 8 days to 5 years, median time was 3 months. The clinical characteristics of SCLE due to PPI were multiple annular erythema or scale plaque on body, limbs and face. One patient was accompanied by arthralgia. The results of laboratory examination showed the positive rates of anti dry syndrome antigen A antibody (SSA), antinuclear antibodies (ANA), anti dry syndrome antigen B antibody (SSB), anti-histone antibody (AHA), and direct immuno fluorescence test were 81.8% (18/22), 76.9% (20/26), 17.6% (3/17), 6.3% (1/16), and 30.0% (6/20), respectively. There were 21 patients who stopped PPI after appearance of SCLE. Of them, 14 patients′erythema disappeared without any treatment, 6 patients′erythema disappeared after receiving symptomatic treatment, and one died after switching to other kind of PPI. There were 5 patients who continued to use PPI after appearance of SCLE. Of them, 2 patients′erythra persisted, 3 patients died.ConclusionsThe characteristics of patients with SCLE due to PPI included the following: most of the patients were more than 50 years old, female, and having history of autoimmune diseases. The key action of improving the prognosis after appearance of SCLE is to stop the medicine immediately.
  • Liu Xiao, Ren Xiaolei, Mu Weijing, Mao Liuying, Ma Chao, Zhang Rui, Zhou Yingqun, Feng Wanyu, Wang Ruitao, Hu Yang, Liang Yan
    . 2018, 20(1): 23.
    ObjectiveTo understand the rationality and safety of oral antihypertensive drugs on chronic renal disease (CKD) combined with hypertension hospitalized patients.MethodsIt was a multi-center and retrospective investigation. The electronic medical records of CKD with hypertension patients who were hospitalized in 6 comprehensive hospitals in Beijing and used oral antihypertensive drugs on October 1st, 2013 to March 31st, 2015 were collected. The pharmacists who participated in the project from the 6 research centers filled out the investigation form. According to the drug instruction, the rationality of antihypertensive medication was evaluated by daily dose, frequency of drug delivery, the dosage for renal insufficiency, contraindications and adverse interactions.ResultsThere were 2 833 valid cases in this study, 1 730 males and 1 103 females. The ratio of male to female was 1∶  0.64. The range of age was 18~101 years. The average age was (61±18) years. There were 1 630 (57.54%) cases whose age was ≥60; 314  (11.1%) cases were CKD level 1, 526 (18.6%) cases were CKD level 2, 1 117 (39.4%) cases were CKD level 3, 423 (14.9%) cases were CKD level 4, 453 (16.0%) cases were CKD level 5. 144 (5.1%) cases were hypertension level 1, 592 (20.9%) cases were hypertension level 2, 1 398 cases (49.3%) were hypertension level 3, and 699 (24.7%) cases were not graded. The oral hypotensive drugs applied during the hospitalization of 2 833 patients included calcium channel blockers (CCB), beta blockers, diuretics, angiotensin Ⅱ receptor blocker (ARB), angiotensin converting enzyme inhibitors (ACEI), alpha/beta blockers and alpha blockers. 1 022(36.1%) cases used 1 kind of antihypertensive drugs, 1 032(36.4%) cases used 2 kinds of antihypertensive drugs, 591(20.9%) cases used 3 kinds of antihyper-tensive drugs, 157(5.5%) cases used 4 kinds of antihypertensive drugs and 31(1.1%) cases used 5 kinds of antihypertensive drugs. A total of 6038 cases of antihypertensive drugs were administered. The top priority was CCB(35.11%, 2 120), the second was beta blockers(17.26%, 1 042) and the third was diuretics(16.23%, 980). The choice of a single drug for antihypertensive drugs was reasonable. The 2, 3, 4, 5 combined drug users who were not recommended by the guidelines were 4.8% (50/1 032), 21.2% (125/591), 28.0% (44/157) and 64.5% (20/31) respectively. The situation of blood pressure control was evaluated with blood pressure target values achieved rate. With blood pressure below 130/80 mmHg as the standard, the admission and discharge blood pressure target achieved rate was 31.2% (884/2 833) and 29.5% (799/2 705) respectively. With blood pressure below 140/90 mmHg as the standard, the admission and discharge blood pressure target achievement rate was 53.6% (1 519/2 833) and 64.4% (1 743/2 705) respectively. Among the 2 833 cases, 903 (31.9%) cases had 1 204 times of unreasonable use of the drug. The top three were excessive daily frequency of medication  (1 029, 85.5%), total daily dosage (114, 9.5%), and use of drugs that were contraindicated (51, 4.2%). Two cases had adverse drug reactions related to antihypertensive drugs.ConclusionThe use of antihypertensive drugs in patients with CKD in the six hospitals involved in the investigation was reasonable, but there was still some problems in the combination of drugs. Some doctors are not familiar with the drug instructions, and there are some problems such as increasing the frequency of drug use, overdose medication, and use of drugs that are contraindicated. Clinical pharmacists should be more involved in clinical work in these areas.
  • Adverse Drug Reactions Journal. 2019, 21(1): 75-75. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.020
  • Lin Chaojin, He Guilin, Jia Nuan, Chen Suichen, Liu Chaoran
    Adverse Drug Reactions Journal. 2024, 26(3): 190-192. https://doi.org/10.3760/cma.j.cn114015-20230801-00572
    A 68-year-old female patient with invasive urothelial carcinoma received immune treatments with disitamab vedotin 120-mg and toripalimab 240-mg intravenously on the first day, and 14 days was a cycle. Nineteen days after the first medication, the patient complained of lower back muscle soreness. Laboratory tests showed creatine kinase (CK) 1-079-U/L and CK-MB 33-U/L. The 2nd cycle of immunotherapy was suspended and prednisone 20-mg orally once daily was given. Five days later, the patient felt chest tightness, and laboratory tests showed CK 3-366-U/L, CK-MB 91-U/L, lactic dehydrogenase 518-U/L, myoglobin 1-282-μg/L, high-sensitivity troponin T 0.068-μg/L, and N-terminal pro-brain natriuretic peptide 148-ng/L. Myocarditis caused by the combination of disitamab vedotin and toripalimab was considered, referring to the cardiac color Doppler ultrasound examination. Prednisone was switched to IV infusion of methylprednisolone 160-mg once daily. The above laboratory test indicators gradually decreased, but the electrocardiogram showed ectopic heart rhythm. Amiodarone was added. After 11 days of methylprednisolone treatment by IV infusion, methylprednisolone 20-mg orally once daily was given, which was gradually reduced and discontinued finally. Four days later, the patient′s laboratory indicators and electrocardiogram showed no abnormalities in the re-examination.
  • Shen Aizong, Zhang Shengyu, Su Dan, Fang Xiaolin, Chen Di
    Adverse Drug Reactions Journal. 2019, 21(1): 50-54. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.009
    Gastrointestinal promotility drugs are effective in treating gastrointestinal diseases such as functional dyspepsia (FD) and gastroesophageal reflux disease (GERD), but there are few effective and safe drugs in the present. Cinitapride hydrogen tartrate (cinitapride) is a gastrointestinal promotility drug that marketed in China in 2015. It belongs to 5-hydroxytryptamine receptor agonist and is mainly used to treat mild to moderate FD. Several clinical trials have shown that cinitapride is superior to metoclopramide or domperidone for treatment of gastrointestinal dysfunction, FD and GERD, and has good safety. Because cinitapride is metabolized not only by cytochrome P450 (CYP) 3A4 enzyme but also by CYP2C8, the risk of drug interaction is lower. The free drug concentration of cinitapride is much lower than that of cisapride and domperidone, resulting in a lower risk of cardiotoxicity. So cinitapride is a new choice for treatment of FD and GERD.
  • Song Lipo, Wang Chunmei, Chu Yanqi, Ji Xunming, Duan Jiangang, Wei Libing, Ning Yachan, Huang Ying, Zhang Jian
    ObjectiveTo analyze the clinical characteristics of liver injury related to edaravone in treating patients with acute ischemic stroke (AIS).MethodsAmong the AIS patients treated with edaravone in Vascular Surgery ICU of Xuanwu Hospital Capital Medical University from January 2014 to October 2017, 9 patients were diagnosed as having liver injury associated with edaravone by active monitoring. The total number of patients treated with edaravone at the same period in Vascular Surgery ICU were obtained from the hospital information system and the incidence of liver injury associated with edaravone was calculated. The clinical data of the 9 patients were collected and analyzed retrospectively.ResultsThe incidence of liver injury associated with edaravone was 8.7% (9/103). The 9 patients included 6 males and 3 females. The age of the patients was 52-83 years and their average age was (65± 6) years. The time for the occurrence of liver injury was 3-9 days and the average time was (6±2) days. The main manifestations of liver injury were increase of alanine aminotransferase (9 cases), aspartic aminotransferase (7 cases), alkaline phosphatase (4 cases), total bilirubin (2 cases), and accompanied by rash in 1 case. Using RUCAM scale, 7 patients were classified as "highly probable" and 2 patients were classified as "probable". Using  "Grade of DILI severity"" standard, all the 9 patients were diagnosed as "mild liver injury". After 4-13 days of edaravone withdrawal, 8 patients had normal liver function and 1 case improved.ConclusionsEdaravone might cause liver injury, mainly manifesting liver dysfunction. The degree of liver injury was mild, and the prognosis was good after timely intervention.
  • Han Yi, Jin Naishi, Mu Yan
    . 2016, 18(2): 140.
    A 74-year-old female patient with coronary artery disease underwent primary percutaneous coronary intervention and received iodixanol 220 ml during the operation.Before the intervention, the patient′s white blood cell (WBC) count was 8.6×109/L, neutrophil (N) count was 4.2×109/L, eosinophil (E) count was 0.36×109/L, and serum creatinine level was 122 μmol/L. On day 4 postoperation, the patient developed erythema of back and right upper limb, swelling of hands (especially the right hand). She was given prednisone 5 mg and loratadine 10 mg once daily. On day 5 postoperation, the patient developed pruritus and pain on generalized skin, erythema of abdomen and thighs, and skin chapping with exudation of right hand. The patient′s WBC count was 12.7×109/L, N count was 8.6×109/L, and E count was 0.73×109/L. Delayed exfoliative dermatitis induced by iodixanol was considered. Dexamethasone 10 mg once daily was given by an IV infusion and calamine lotion was externally applied on the skin surface. After 4 days of treatments, the pruritus was improved and the patient developed excessively keratinization with pachulosis and crusting in the right hand and arm. Dexamethasone was stopped. After 14 days of treatments, the patient′s WBC count was 10.6×109/L, N count was 6.6×109/L, and E count was 0.37×109/L; her skin returned to normal.Then, prednisone and loratadinetreatments were stopped.
  • Wang Lijun, Liu Gang, Wang Yu, Zhan Hanqiu, Tang Yanfen, Chen Qi
    . 2015, 17(6): 471-472.
    A 41-year-old man with epilepsy after glioblastoma resection received oral oxcarbazepine (an initial dose of 0.3 g twice daily, which was increased to 0.6 g twice daily) and valproate sodium (500 mg, once daily). Nasal feeding lamotrigine 25 mg twice daily was added to her regimen due to poor control of epileptic condition. On day 17 of lamotrigine therapy, an IV infusion of ceftriaxone 2 g once daily was given for pulmonary infection. On day 19 of lamotrigine therapy, the patient developed red maculopapular eruptions successively on the face, neck, chest, back, arms, abdomen and legs, some rashes fused into lamella. He was diagnosed drug eruptions. Lamotrigine and ceftriaxone were discontinued immediately. Oxcarbazepine and valproate sodium were continued. He was given dexamethasone, calcium gluconate and vitamin C. Five days later, his skin lesions were improved. Nine days after lamotrigine withdrawal, the skin eruptions subsided.
  • Zhang Huijie, Tang Shaohui
    . 2017, 19(5): 399.
    A 51-years-old female patient with acute gastroenteritis and pneumonia received an IV infusion of levofloxacin mesylate and sodium chloride injection 0.4 g once daily. On day 10, the patient developed dizziness, chest tightness, and palpitations. Her pulse rate was 45 beats/min, heart rate was 47 beats/min, and blood pressure was 105/56 mmHg (1 mmHg=0.133 kPa). Electrocardiogram revealed sinus bradycardia and sinus arrhythmia. The electrocardiographic change was considered to be related to levofloxacin mesylate and sodium chloride injection treatment. Low flow oxygen and an IV infusion of isoproterenol 1 mg were given. After 1 hour, the patient pulse rate was 65 beats/min, heart rate was 67 beats/min, blood pressure was 120/76 mmHg, dizziness relieved. The electrocardiogram showed sinus rhythm. The levofloxacin mesylate and sodium chloride injection was stopped by the doctor orally, however, the treatment was not recorded in the medical record. The next day, levofloxacin mesylate and sodium chloride injection 0.4 g was given again. The above symptoms recurred after 5 hours. The electrocardiogram showed sinus bradycardia, the heart rate was 53 beats/min. After the same treatment as that used the previous day, the patient recovered.
  • Liu Aihua
    . 2010, 12(3): 206-3.
    Four patients (three men and one woman aged 22-60 years) were diagnosed as having viral encephalitis, symptomatic epilepsy, trigeminal neuralgia and cerebral hemorrhage, respectively. They received carbamazepine 0.10.2g three times daily. Within one month after starting carbamazepine, they developed apathy, somnolence and anorexia. Their serum sodium levels decreased from 141.0, 143.0, 141.6 and 139.8mmol/L to 122.2, 112.1, 121.8 and 116.6 mmol/L, respectively. Carbamazepine was withdrawn and changed to other drugs. Meanwhile the patients received symptomatic and supportive therapies. Their levels of serum sodium returned to 138.0, 144.0, 139.2 and 144.2 mmol/L, respectively.
  • 病例报告
    . 1999, 1(3): 186-186.
  • WHO信息
    . 2004, 6(1): 62-62.
  • 不良事件
    . 2003, 5(1): 28-28.
  • 不良事件
    . 2005, 7(3): 228-228.
  • 病例报告
    . 2000, 2(3): 195-195.
  • 病例报告
    . 2003, 5(2): 87-87.
  • 病例报告
    . 2005, 7(5): 375-376.
  • 病例报告
    Jiang Liang;Zhong Qiang;Lu Xiaoxiao
    . 2008, 10(4): 0-0.

    A 40yearold woman with acute pyelonephritis received an intravenous infusion of cefotaxime sodium 2 g dissolved in 250 ml of sodium chloride 0.9%. No adverse reactions were found. Later, fleroxacin 0.4 g dissolved in 500 ml of glucose 5% was infused intravenously. She developed chill after receiving about 250 ml of the infusion. Her BP was 100/70 mmHg, and HR was 84 beats/min. The infusion was stopped. She was given IM promethazine and IV dexamethasone. Approximately 17 minutes later, convulsion of her extremities, undetectable blood pressure, heart arrest, and respiratory arrest occurred in the woman. Despite continuous resuscitation efforts, she died.

  • 系列问答
    . 2008, 10(3): 223-2.
  • 中药不良反应
    Zhang Yanhua;Ling Shihua
    . 2008, 10(3): 219-1.

    A 42yearold woman, who had an over 10year history of adnexitis, took Jingangteng syrupus 10 ml thrice daily intermittently. At that period of time, the results of her liver function tests were normal. However, the patient presented with generalized asthenia and nausea after receiving Jingangteng syrupus for two consecutive years in recent years. Laboratory tests revealed the following values: ALT 525 U/L, AST 520 U/L. Serologic tests for hepatitis A, B, C, D, and E were negative. A liver biopsy was consistent with the pathologic changes in druginduced hepatic injury. Jingangteng syrupus was discontinued. After one month of liverprotective treatment, her liver function tests normalized.The authors suggest that the Jingangteng syrupusinduced hepatic injury might be associated with its longterm use, and attention should be paid for the longterm use of this drug in clinical practice.

  • 不良事件
    . 2002, 4(3): 200-200.
  • 安全信息
    . 2009, 11(1): 72-1.
  • 安全信息
    . 2009, 11(4): 299-1.
  • 病例报告
    . 2006, 8(6): 453-453.
  • 病例报告
    . 2001, 3(3): 186-186.
  • 病例报告
    . 2002, 4(1): 46-46.
  • 病例报告
    . 2004, 6(4): 239-239.
  • 病例报告
    . 2000, 2(4): 220-220.
  • 病例报告
    . 2000, 2(4): 260-260.
  • 病例报告
    . 2000, 2(4): 261-261.
  • 病例报告
    . 2001, 3(3): 199-200.
  • 病例报告
    . 2006, 8(5): 371-372.
  • 安全用药
    . 2004, 6(2): 95-96.
    近年,随着促红细胞生成素临床应用的增多,其引起纯红细胞再生障碍性贫血的报道有所增加,本文根据国外文献报道,探讨促红细胞生成素引起纯红细胞再生障碍性贫血发病机制,及其诊断、治疗和预防。
  • ADR护理
    . 2002, 4(1): 33-34.
  • 药物评介
    . 2001, 3(4): 271-273.
  • 中毒救治
    . 2005, 7(6): 435-436.
    本文通过我院收治的1例复方苯乙哌啶片中毒及既往报道的中毒病例,对复方苯乙哌啶片引起的神经系统损害进行临床分析,以期对临床安全使用该药有所警示。
  • 政策法规
    . 2006, 8(2): 124-126.
  • 病例报告
    . 2002, 4(2): 123-124.
  • 专题讲座
    . 1999, 1(2): 128-132.
  • 专题讲座
    . 2000, 2(1): 65-69.
  • 中药不良反应
    . 2007, 9(2): 145-145.
  • 病例报告
    . 2007, 9(2): 149-149.
  • 病例报告
    Huang Jiantong;Li Peilan
    . 2011, 13(1): 59-2.
    A 53yearold male patient with pharyngitis was given an IV infusion of clindamycin 600 mg dissolved in 0.9% sodium chloride 250 ml. After infusion completion, the patient developed a coma and unresponsiveness to verbal stimuli. His respiratory rate was 12 breaths/min and his pupils showed no light reflex. He received oxygen inhalation therapy and fluid supplement and, one hour later, he remained in a deep coma. The patient was treated with mannitol, furosemide,naloxone,puerarin and sodium ozagrel by intravenous infusions, respectively. After about 12 hours of treatment, the patient regained consciousness and, after about 15 hours of treatment, he suddenly presented with mania. IM haloperidol 5 mg was given. After about 20 hours of treatment, his mental condition basically returned to normal.
  • 论著
    Li Geng;Peng Shaozhong;Cai Dake;Lai Xiaoping;Su Ziren
    . 2011, 13(3): 153-4.
    Objective: To evaluate the improved hemolysis test method for detecting a hemolytic reaction induced by puerarin injection. Methods: Twenty-four Beagle dogs (body weight 6-8 kg,the ratio of male to female was 1∶1) were obtained and 50% and 2% fresh erythrocyte suspensions were prepared. The standard hemolysis test method in the 2005 edition of the Chinese Pharmacopoeia and improved hemolysis test method established by our laboratory were used in this study. The features of the improved method were increase in puerarin concentration and incubation time. Beagle dog erythrocytes were incubated with different concentrations of puerarin injection and/or propylene glycol, and the hemolytic reaction was observed. In addition, the normal saline and the distilled water served as the negative and positive control, respectively. The incidence of hemolysis was calculated and all results were analyzed statistically. Results: When using the standard hemolysis test method in the pharmacopoeia, no hemolysis occurred in Beagle dog erythrocytes within 3 hours following application of propylene glycol 3.3-16.7 ml/L and puerarin 0.33-1.67 mg/ml. When using improved hemolysis test method, hemolytic phenomenon occurred in 4 Beagle dogs’erythrocytes following application of propylene glycol 100 ml/L, and the incidence of hemolysis was 16.6%; compared with the negative control, the difference was statistically significant (P<0.05); in addition, hemolytic phenomenon occurred in 16 Beagle dogs’erythrocytes following application of propylene glycol 100 ml/L and puerarin 10 mg/ml, the incidence of hemolysis was 66.7%; the difference was statistically significant, compared with the negative control (P<0.01). Correlation analysis showed that the incidence of hemolysis was not correlated with the concentration of propylene glycol (r=0.571, P>0.05), and significantly correlated with the concentration of puerarin(r=0.952, P<0.01). Conclusion: The improved hemolysis test method appeared to be more effective than the standard hemolysis test method in detection of a hemolytic reaction induced by puerarin injection.
  • . 2013, 15(5): 247-1.
  • . 2016, 18(5): 352.
  • 病例报告
    Li Ying;Xu Zheng;Zhang Haiying;Feng Wanyu;Gong Pihua
    . 2014, 16(3): 176-2.
    An 86-year-old female patient with pulmonary infection was treated with IV infusions of ceftriaxone sodium 2.0 g once daily, azithromycin 0.5 g once daily, and ambroxol hydrochloride 30 mg twice daily. About 30 minutes after the fourth infusion of azithromycin, the patient abruptly developed chest tightness and suffocation. Electrocardiography showed Ⅲ degree atrioventricular block. Azithromycin was stopped immediately and she was treated with oxygen inhalation. One hour later, the symptoms of chest tightness and suffocation disappeared. Five hours later, a repeat electrocardiography showed sinus rhythm. Azithromycin was not given again and the similar symptoms did not recur any more.
  • 病例报告
    Qi Hongliang;Zhou Hui;Li Li
    . 2014, 16(2): 121-2.

    A 71-year-old male patient received intravenous amiodarone 150 mg followed by amiodarone 600 mg with continuous microdose venous pump after pacemaker implantation. Liver function was normal before the operation. On day 3 of drug use, the patient presented with nausea, vomiting, and yellowish skin with a alanine aminotransferase (ALT) value of 2 954 U/L, a aspartate aminotransferase (AST) value of 156 U/L, a total bilirubin (TBil) value of 56.4 μmol/L, a direct bilirubin (DBil) value of 37.4 μmol/L, and an indirect bilirubin (IBil) value of 19.0 μmol/L. Amiodarone was withdrawn and protective liver therapy was given. On day 5 of amiodarone withdrawn, tests revealed the following values: ALT 965 U/L, AST 296 U/L, TBil 35.6 μmol/L, DBil 21.3 μmol/L, and IBil 14.3 μmol/L, and on day 15, ALT 37 U/L, AST 27 U/L, TBil 14.0 μmol/L, DBil 6.7 μmol/L, and IBil 7.3 μmol/L.

  • Sun Wenfang, Xia Binbin, Cheng Hua
    Adverse Drug Reactions Journal. 2024, 26(2): 87-92. https://doi.org/10.3760/cma.j.cn114015-20231121-00829
    Objective To mine and analyze the signals of the adverse event (AE) of erenumab and provide reference for the safe application of the drug. Methods The reports of AE from 2004 to the first quarter of 2023 were extracted from the US FDA Adverse Event Reporting System database, and the full data and data after 2018 were analyzed respectively. AEs were classified according to preferred term (PT) and the system organ class (SOC) of Medical Dictionary for Regulatory Activities (MedDRA) 23.0 version for statistical analysis. The reported odds ratio (ROR) method and Bayesian confidence progressive neural network (BCPNN) method were used to mine the AE risk signals. Results A total of 38-348 AE reports with erenumab as the primary suspect drug were collected, involving 2-629 PTs. The number of risk signals screened by the ROR and BCPNN methods from the full data and data after 2018 was 99 and 115, respectively, involving 19 SOCs. Among them, the most frequently reported AEs were injection site reactions and constipation, which were consistent with the label. Among the top 30 PTs, 13 were not recorded in the label, including pineal cyst, postural tachycardia, positive histone antibody, spastic eye movements, fear of injection, post-concussion syndrome, Raynaud effect, psychogenic seizures, coronary artery dissection, premature menopause, trichorrhexis, collagen disease, and blepharospasm. Conclusion In clinical application of erenumab, in addition to the adverse reactions recorded in the label, attention should also be paid to the adverse events mined in this study.
  • ong Xiaoying, Zheng Xiaoxian, Yu Xun, Cao Xiufang
    Adverse Drug Reactions Journal. 2024, 26(2): 101-105. https://doi.org/10.3760/cma.j.cn114015-20230904-00655
    Objective To explore the effects of pharmaceutical services through enterprise WeChat for outpatients with cancer pain. Methods A retrospective study was conducted on patients who were first diagnosed and/or previously treated for cancer pain and visited Outpatient Department of the First Affiliated Hospital of Soochow University from January 1, 2020 to January 30, 2023. The outpatients were divided into conventional pharmaceutical services management group (conventional group) and pharmaceutical services management group through enterprise WeChat (enterprise WeChat group) based on whether they received pharmaceutical services for cancer pain through enterprise WeChat. Prescription appropriateness, changes in cancer pain and life quality evaluation indicators after treatment in patients between the 2 groups were recorded and compared. Results A total of 174 patients were included, with 87 patients in each group. There were no significant differences in age and gender between the 2 groups (all P>0.05). Before the pharmaceutical services management for cancer pain through enterprise WeChat, the differences in the proportion of patients with pain free, mild, moderate, and severe pain after pain relief treatments between the 2 groups were not significant (all P>0.05). In the conventional group, 13 out of 87 patients (14.9%) had inappropriate prescriptions, and 2 out of 87 (2.3%) in the enterprise WeChat group, with statistically significant difference (χ2=8.828, P<0.05). After management with enterprise WeChat, the patients of pain-free increa- sed from 19 to 55 (63.2%) in the enterprise WeChat group, and from 18 to 41 (47.1%) in the conventional group. The difference in the proportion of pain-free patients between the 2 groups was statistically significant (χ2=4.555, P=0.033). The differences in the scores of various indicators of life quality between the 2 groups before management with enterprise WeChat were not significant (all P>0.05). After the management with enterprise WeChat, life quality scores in all the 8 dimensions were significantly higher than those in the conventional group (all P<0.05). Conclusion The utilization of enterprise WeChat could improve the treatment effect of cancer pain, enhance their life quality, help improve the quality of pharmaceutical services, and have certain promotion and utilization value.
  • Liu Jinchun, Zhang Fan
    Adverse Drug Reactions Journal. 2023, 25(2): 114-116. https://doi.org/10.3760/cma.j.cn114015-20220411-00300
    Two patients (patient 1, a 49-year-old female; patient 2, a 51-year-old female) took Anshen Bunao liquid 10-ml twice daily orally by themselves because of poor sleep. None of the 2 patients had concomitant medications. Patient 1 and patient 2 developed fatigue and poor appetite after 7 and 10 days of Anshen Bunao liquid treatment, respectively. Laboratory tests showed that alanine aminotransferase (ALT), aspartate transaminase (AST), and alkaline phosphatase (ALP) were 1-147-U/L, 1-271-U/L, 215-U/L and 805-U/L, 333-U/L, 227-U/L, respectively. Then Anshen Bunao liquid was stopped and hepatoprotective therapy was given. Seven days later, symptoms of fatigue and poor appetite in the 2 patients were improved, amd laboratory tests showed that the levels of ALT, AST, ALP decreased to 222-U/L, 396-U/L, 122-U/L and 85-U/L, 23-U/L, 129-U/L, respectively. Patient 1 took Anshen Bunao liquid again. Two days later, she developed abdominal discomfort with vomiting, ALT was 409-U/L, and AST was 339-U/L. After stopping the drug and giving liver-protective treatments for nearly 4 months, ALT was 32-U/L, AST was 22-U/L, and ALP was 89-U/L. Patient 2 did not take the drug again. Re-examination after 138 days after discharge, ALT was 39-U/L, AST was 28-U/L, and ALP was 130-U/L.
  • 病例报告
    Wang Jianmin;Yang Shengping;Hu Long
    . 2014, 16(1): 39-2.
    A 51-year-old male patient, who was treated with warfarin 2.5 mg once daily for 5 years after cardiac valve replacement, received IM dipyrone for his cold (dose not stated). He developed pain, swelling and ecchymosis of left buttock after 3 days. Ultrasonic examination showed low echo area on the left buttock. Laboratory tests showed an international normalized ratio (INR) 6.2. Warfarin was stopped and an IV infusion of vitamin K1 40 mg once daily was given. Three days later, the INR value decreased to 1.0. Incision and drainage on the left buttock was performed. On the second day after operation, the INR was 1.2 and warfarin was received again according to original dosage. Two weeks later, the area of ecchymosis was reduced, and INR level was 2.0. After one month of follow-up, the ecchymosis subsided completely, the INR level was 2.1.
  • Wang Jie, Zhang Fubin, Zhang Fang, Ma Shuai, Du Tiekuan
    . 2016, 18(3): 209.
    Two male patients (aged 73 and 62 years, respectively) received an intravenous infusion of ertapenem 0.5 g once daily and 1.0 g once daily for perianal abscess and intestinal obstruction. On day 5 and 9, the two patients developed neuropsychiatric symptoms, such as seizures, hallucination and sleep-walking. Ertapenem was withdrawn, the neuropsychiatric symptoms did not recur.
  • YU Jian-liang
    . 2013, 15(5): 289-2.
    A 67-year-old male patient with gingivitis received ornidazole orally 1.0 g once daily, cefradine 0.5 g thrice daily, and paracetamol 0.5 g twice daily. Three days later, the pain was relieved, but the patient developed dizziness, headache, and fatigue. Cefradine and paracetamol were stopped and ornidazole was continued. Four days later, the patient developed sudden mental disorder,which was mild during the daytime and severe at night. EEG examination revealed that frequency of α waves became slow and irregular and scattered θ waves appeared. The patient was diagnosed with delirium. Ornidazole was stopped. IM haloperidol 5 mg once daily, IV infusion of vitamin B6 0.2 g, adenosine triphosphate 40 mg, coenzyme A 200 U, and vitamin C 2.0 g in 10% glucose and sodium chloride injection 1000 ml, and oral olanzapine 5 to 10 mg twice daily were given. Three days later, the patient′s consciousness recovered. Then, haloperidol was stopped and the dose of olanzapine was reduced to 0.25 g once daily. On day 6 of treatments, the patient′s dizziness, headache, and fatigue disappeared, physical strength recovered, and EEG examination showed normal results. On day 7 of treatments, antipsychotics were discontinued. After more than 3 months of follow-up, the patient′s mental state was normal.
  • XIE Li-jing;TANG Li-ping
    . 2013, 15(6): 330-6.
    ObjectiveTo explore whether it would be possible to distinguish the poisonous mushrooms and the confusable edible mushrooms by visualized method and provide the basis for prevention and treatment of mushroom poisoning.MethodsThe types of dangerous poisonous mushrooms were confirmed by literature and experts′ opinions. The macroscopical morphological features were compared between the common poisonous mushrooms and the edible mushrooms. The specimens of mushroom were field-collected and the macroscopical and microcosmic features were identified by traditional morphological method. The visualized identification methods of poisonous mushrooms reported in literature, books and periodicals, and circulated among the people were tested and verified with examples.ResultsFifteen kinds of common and dangerous poisonous mushrooms were selected preliminarily. The macroscopical morphological features were compared between the common poisonous mushrooms and the confusable edible mushrooms according to the professional books, literature and the experience. The results of the above-mentioned comparison proved that it was impossible to distinguish the poisonous mushrooms and the confusable edible mushrooms according to macroscopical morphological features only. The traditional morphological features (including both macroscopical and microcosmic features) of 12 kinds of field-collected mushroom species were identified. The results showed that the identification of mushroom′s type must be completed by the taxonomic professionals according to the macroscopical and microcosmic features. The results of verification showed that none of the 6 kinds of visualized methods which were widely circulated could be used as general identification method of poisonous mushrooms. ConclusionsThere is no simple and general visualized identification method for poisonous mushrooms at present. The stress of control poisonous mushrooms poisoning should be put on the study of identifying technique and the correction of misunderstanding in identification of poisonous mushrooms.
  • HU Xiao-jing;SUN Xin-min;HUANG Wen;QIU Heng;MU Ji-zheng;WANG Li-xia;WANG Qi
    . 2013, 15(5): 248-6.
    ObjectiveTo observe the effects of Yuhong Ointment on rat′s liver and kidney functions and histomorphology of heart, brain, liver, kidney and spleen after transdermal administration repeatedly, in order to provide experimental evidences for safe use of Yuhong Ointment in clinical practice.MethodsA total of 100 SPF SD rats of equal number of both genders, weighting 200 g, were divided into 5 groups: matrix control group, 1 time concentration of Yuhong Ointment group (containing 0.4% calomel), 2 times concentration of Yuhong Ointment group (containing 0.8% calomel), 4 times concentration of Yuhong Ointment group (containing 1.6% calomel) and calomel group (containing 1.6% calomel) by drawn lots randomly, each group comprised 20 rats. The model of rat′s skin injury was prepared. Yuhong Ointment in different concentrations were applied on the skin-impaired once daily for 28 days. The levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), creatinine (Cr) and N-acetyl beta-D glucosaminidase (NAG) of rats in different groups were measured before treatment, 14 and 28 days after treatment, and 28 days after drug withdrawal, respectively. Ten rats in every group were sacrificed on 28 days after treatment and 28 days after drug withdrawal, respectively. The heart, brain, liver, kidney, and spleen of rats in different groups were taken and weighed up. The organ coefficients were calculated and the histomorphological changes of liver, kidney and spleen were examined.ResultsThere were no statistically significant differences in levels of serum ALT、AST、BUN、Cr and NAG in rats among the different concentrations of Yuhong Ointment groups, 1.6% calomel group and matrix control group (all P>0.05) . The level of serum Cr in rat of 1.6% calomel group was significantly higher than that of matrix control group 28 days after drug withdrawal (P<0.05). The kidney coefficients of rats in 2 times and 4 times concentration of Yuhong Ointment group and 1.6% calomel group were significantly higher than that in the matrix control group (P<0.05) on 28 days after treatment and 28 days after drug withdrawal. The differences of coefficients of heart, brain, liver, and spleen of rats in different groups were not statistically significant (all P>0.05). There were no obvious morphological changes in liver, kidney and spleen in different groups 28 days after treatment.ConclusionsNo obvious toxic reactions were observed in rats after transdermal administration of Yuhong Ointment repeatedly. The high concentrations of Yuhong Ointment maybe bring reversible kidney injury. The kidney function of patient who received large volume of Yuhong Ointment for long-term should be monitored.
  • 病例报告
    Feng Renyang
    . 2010, 12(3): 220-1.
    A 46yearold male patient received allopurinol 0.2 g twice daily for hyperuricaemia. After 28 days of therapy, the patient experienced sheeted edematous erythema with itching on his trunk and extremities. Allopurinol was stopped. Subsequently, his symptoms worsened and he presented with generalized flushing, and swelling with purpura, palpebral edema, perioral exudation and sabbing. Laboratory examinations revealed a WBC count of 20.2×109/L with 0.32 eosinophils and an ALT level of 52 U/L. A bone marrow smear showed his eosinophils increased.The patient was treated with an IV infusion of methylprednisolone 80 mg dissolved in 5% glucose 250 mL. Three days later, his symptoms improved.
  • 病例报告
    Qiao Weia;Li Yimingb;Shen Lingmeia;Zhang Xiaopinga
    . 2010, 12(5): 353-2.
    A 100yearold male patient with pneumonia received an IV infusion of imipenem/cilastatin sodium 0.5 g in 0.9% sodium chloride 100 mL every 12 hours. Two hours after the second infusion completion, the patient suddenly presented with confusion, upward gaze, trismus, and cyanosis. His heart rate was 126 beats/min, blood pressure was 178/86 mm Hg, and oxygen saturation was 80%. Supportive and symptomatic treatment was given immediately and, about four minutes later, the symptoms improved. Imipenem/cilastatin sodium was withdrawn and changed to meropenem. Ten days later, his pneumonia was cured. Imipenem/cilastatin sodium were not given again and epileptic seizure did not recur anymore.
  • 病例报告
    Zhao Yunyan;Wu Jinlan;Li Guozhong
    . 2010, 12(5): 356-2.
    A 81yearold woman received an IV infusion of ceftazidime 3.0 g dissolved in 250 mL of 5% glucose, twice daily, and an IV infusion of 0.5% ornidazole 100 mL once daily, respectively, for ossifying fibroma with facial cellulitis in her left lower jaw bone. In that evening the patient developed involuntary tremor of head and right hand. The laboratory examination and electrocardiogram showed no marked change. No abnormal changes were found on her cranial CT examination except slight encephalatrophy. She was given IM diazepam 10 mg and oral levodopabenserazine 0.125 mg,thrice daily. Three days later, her symptoms did not improved. Her tremor was considered to be ceftazidimeinduced extrapyramidal reactions. Ceftazidime was discontinued and changed to cefazolin. Her other medicines remained unchanged. Her left facial cellulitis improved and tremor disappeared.
  • 病例报告
    . 2007, 9(2): 134-135.
  • 病例报告
    . 2000, 2(1): 51-51.
  • 病例报告
    . 2007, 9(1): 53-53.
  • 安全用药
    . 2001, 3(4): 230-231.
  • 病例报告
    . 2005, 7(1): 4-4.
  • ADR监测与防治
    . 2000, 2(3): 171-174.
  • 病例报告
    . 2006, 8(2): 134-135.
  • 国外文献题录
    . 2003, 5(5): 350-351.
  • 病例报告
    . 2000, 2(4): 258-259.
  • 病例报告
    . 2000, 2(4): 255-256.
  • 病例报告
    Cheng Sheng
    . 2009, 11(3): 205-2.
    A 55yearold woman, who had no previous history of liver disease, received nimesulide 0.1 g twice daily for prolapse of lumbar intervertabral disc. Twenty days later, the patient developed epigastric distention and pain, nausea, and anorexia. Liver function examination showed the following values: ALT 377 U/L, AST 105 U/L, TBil 13.72 μmol/L. She had negative serology for HBsAg and hepatitis A, C, E antibodies. Ascites were evident on an ultrasonography, an abdominal paracentesis was performed, and 180 ml of turbid yellow ascitic fluid were drained off. Routine tests revealed that her ascitic fluid contained WBC 1 720×106/L; a Rivata test was positive. Nimesulide was stopped, and polyene phosphatidylcholine, compound glycyrrhizin, glucurolactone, and levofloxacin were given. On day 10 after hospitalization, her ascitic fluid was disappeared. Then her liver function gradually improved and he was disoharged. Two months after discharge, her liver function returned to within normal ranges.
  • Ding Yongfu
    Adverse Drug Reactions Journal. 2009, 11(5): 320-1.
    A 63yearold man received an IV infusion of bromhexine 16 mg for cough after repair of inguinal hernia. During infusion, the patient developed polyhidrosis, hypermyotonia of both lower extremities, as well as talipes varus and inflexion. Bromhexine was stopped, an IV infusion of 20 ml of calcium gluconate 10% was given. Twenty minutes later, the symptoms improved. Three days later, he was discharged and his symptoms disappeared completely.
  • 中毒救治
    . 2006, 8(4): 284-284.
  • 安全信息
    . 2008, 10(2): 152-1.
  • 病例报告
    . 2001, 3(2): 104-104.
  • 病例报告
    . 2001, 3(3): 196-196.
  • 药物评介
    . 2000, 2(3): 202-204.
  • 不良事件
    . 2006, 8(1): 63-63.
  • 病例报告
    . 2006, 8(1): 50-51.
  • 不良事件
    . 2005, 7(5): 386-386.
  • 病例报告
    . 2000, 2(2): 125-125.
  • 病例报道
    . 1999, 1(2): 125-125.
  • 病例报告
    Xing Dan
    . 2010, 12(4): 294-2.
    A 47yearold woman was hospitalized for aggravated symptoms of thrombocytopenic purpura. After admission, she received amifostine and platelet transfusion. On day 11, her temperature was 38.8 ℃ and then she was given ibuprofen 0.05 g. The next day, the patient developed whealandred rash with pruritus in both lower limbs. On day 13, her temperature was 38.9 ℃, the patient was administered ibuprofen 0.05 g again. Subsequently, she presented with red wheal in extremities, chest, and back, and some rashes fusing into lamella in knees and buttocks followed by marked pain in her feet and knees. On day 17, her temperature was 39.5 ℃. After the third administration of ibuprofen 0.1 g, she developed obviously generalised pain and vesicles in her jaw, both upper arms, abdomen, and back. She underwent physical methods for lowering fever and received glucocorticoid and human immunoglobulin. Meanwhile she received symptomatic therapies for vesicles. Her symptoms improved and, on day 21, the laboratory test revealed a PLT count of 151×109/L. She recovered and was discharged after one month of hospitalizaiton.
  • 病例报告
    Wang Xinyu;Xu Xinye;Sun Chao;Niu Jie;Gao Wei
    . 2011, 13(3): 189-2.
    A 68-year-old woman with malignant gastric stromal tumor received imatinib 400 mg once daily after surgery. Half a year later, ultrasonic cardiogram showed a mild pericardial effusion. Five years later, the patient developed mild edema in both lower extremities and atrial fibrillation, and ultrasonic cardiogram showed a moderate pericardial effusion. Imatinib was discontinued and, two weeks later, pericardial effusion decreased. Three weeks later, pericardial effusion subsided completely, atrial fibrillation did not recur, and her lower limbs edema significantly improved. Imatinib was readministered according to the above-mentioned dosage. Two weeks later, a little pericardial effusion appeared and, on months 3 and 6, ultrasonic cardiogram revealed no pericardial effusion and she did not present with atrial fibrillation.
  • 安全信息
    . 2012, 14(2): 87-1.
  • 述评
    . 2014, 16(2): 65-3.
  • 论著
    Zhang Ti;Zhou Jingkai;Liu Mei;Li Shuang;Zhao Limei;Chen Yu
    . 2014, 16(5): 264-5.
    ObjectiveTo investigate the efficacy, safety and compliance of valproic acid (VPA) monotherapy and VPA in combination with oxcarbazepine (OXC) in children with epilepsy.MethodsA retrospective analysis of clinical data of children with epilepsy, treated in Shengjing Hospital of China Medical University from October 2012 to October 2013 was performed. The patients were treated with VPA (VPA group) or VPA in combination with OXC (VPA+OXC group) continuously for more than 2 months and were followed up for 1 year. The situation of drug use [VPA daily dose, OXC daily dose, concentration dose ratio (CDR) of VPA, medication compliance(evaluated by retention raty)], situation of epilepsy control and occurrence of adverse reactions were recorded and compared.ResultsA total of 208 children were included in the study, 105 children were in the VPA group, 62 male cases and 43 female cases, aged 1 to 15 years, mean (6.8±3.4) years; 103 children were in the VPA+OXC group, 60 male cases and 43 female cases, aged 1 to 15 years, mean (7.4±3.5) years. There was no significant difference in VPA daily dose, CDR, and the retention rate [(507±207) mg vs.(498±164) mg, (4.2±2.3) (μg·kg)/(ml·mg) vs. (4.3±1.6) (μg·kg)/(ml·mg), 81.9% vs. 79.6%, respectively, P>0.05)]. At one year follow-up, the efficacy rate in the VPA+OXC group [82.5% (85/103)] was significantly higher than that in the VPA group [61.9% (65/105)] (P<0.05). During one year of follow-up, there was no significant difference in liver function abnormalities and adverse reactions in the VPA and VPA+OXC groups [13.3%(14/105) vs. 15.5%(16/103), 4.8%(5/105) vs. 6.8%(7/103), respectively, P>0.05]. But the incidence of adverse reactions in the 2 groups and the liver function abnormalities in the VPA+OXC group in children aged from 1 to 10 years were higher than that aged from 11 to 15 years (P<0.05); the incidence of adverse reactions and liver function abnormalities in children with CDR of 5-13 (μg·kg)/(ml·mg) was higher than that in children with CDR of 1-5 (μg·kg)/(ml·mg) (P<0.05).ConclusionsThe efficacy, safety and compliance of VPA in combination with OXC treatment is better than that of VPA monotherapy in children with epilepsy. Age and the plasma concentration maybe the risk factors of adverse reactions and liver function abnormalities.
  • Du Qiu, Zhang Jinping
    . 2018, 20(1): 65.
    A 66-year-old male patient with obstructive jaundice by percutaneous transhepatic cholangial drainage operation, pulmonary infection was found 15 days later, An IV infusion of cefodizime 2 g once every 12 hours was given for about 12 d and then was shifted to oral cefaclor suspension liquid 0.25 g once every 8 hours. Two days after drug administration, he developed red papules on chest, back and both lower limbs, without itching, adverse reactions induced by cefaclor were considered. The red papules subsided after cefaclor was stopped and intramuscular injection of promethazine hydrochloride 12.5 mg was given. Eight days after stopping cefaclor, the patient underwent an operation which was "explorative laparotomy and hepatic hilar biopsy for a space-occupying lesion" under general anesthesia. An IV infusion of cefodizime 2 g once every 12 hours was given again for antiinfection, and comprehensive support treatment for prevention of stress ulcer, analgesia, liver protection drugs were given. Three days later, the patient developed skin itching, herpes on lips, facial and torso redness, slight swelling, high skin temperature, a little damder, and erosion on mouth, genital and other parts of the body could be seen with exudation. Exfoliative dermatitis induced by cefodizime was considered. Then all drugs were immediately stopped, IV infusion of methylprednisolone 40 mg, once daily, compound glycyrrhizin injection 60 ml, once daily; oral loratadine 10 mg, once daily; topical use calamine lotion; sodium bicarbonate mouthwash. Two days after administration of the drugs, the patient began to have desquamation, 7 days later the symptoms of exfoliative dermatitis had mitigated, the symptoms of infection gradually improved without using any other anti-infective drugs. Sixteen days later, the symptoms got improved and no symptoms recurred.
  • Zhang Hongyu, Teng Fei, Ye Wei, Wen Yubing, Zheng Ke
    Adverse Drug Reactions Journal. 2023, 25(8): 504-505. https://doi.org/10.3760/cma.j.cn114015-20220919-00854
    A 67-year-old female patient with lymph node metastasis from lung adenocarcinoma received the treatment of chemotherapy, immunotherapy, and targeted therapy (cisplatin, pemetrexed, pembrolizumab, and lenvatinib) at the same time. After the end of the third cycle of treatment, the patient developed elevated blood pressure (160/100-mmHg), blood creatinine increase (from 90-μmol/L to 160-μmol/L), anemia (hemoglobin 90-g/L), and metabolic acidosis (total carbon dioxide 18-mmol/L). Renal histopathological exami- nation showed tubulointerstitial damage. Excluding kidney injury caused by other drugs, it was considered to be the immune adverse reaction caused by pembrolizumab. The drug was discontinued and hormone, antihypertensive, and symptomatic treatments were given. After 5 months, the patient′s blood pressure was 110-120/70-80-mmHg, serum creatinine decreased to 130-μmol/L, hemoglobin was 117-g/L, and total carbon dioxide was 26-mmol/L.
  • Su Yunjuan, Song Yuqing, Dong Qian, Yang Liu, Chen Yongfu, Zhang Sujuan, Wu Qiming
    ObjectiveTo explore the clinical characteristics, prevention, and treatment of acute liver injury (AHI) induced by intravenous amiodarone.MethodsThe medical records data of 5 patients with AHI caused by intravenous amiodarone in our hospital were collected and retrospectively analyzed, and in the meantime, case reports on intravenous amiodarone-induced AHI in PubMed, CNKI and Wanfang Data were searched. The clinical data of 5 patients in our hospital and case reports from the literature were summarized and the clinical characteristics of AHI induced by intravenous amiodarone were analyzed.ResultsThe 5 patients with AHI induced by intravenous amiodarone in our hospital included 3 males and 2 females with ages of 22-70 years. The total doses of amiodarone were 450-750 mg, incubation periods (the period from drug use to AHI occurrence) were 24-48 h, and the types of liver injury were all hepatocyte type, of which 2 patients′  were liver failure. A total of 59 patients with amiodarone-induced AHI were collected (5 in our hospital and 54 from the literature), including 40 males (67.8%) and 19 females (32.2%) with ages from 1 year and 10 months to 93 years and a median age of 69 (58, 75) years. In these 59 patients, the incubation periods ranged from 6 hours to 8 days and the median period was 2 (1, 3) days, and that of 55 patients (93.2%) were less than or equal to 3 days. The incubation periods of 17 patients with liver failure and 42 patients with non-liver failure were 1 (1, 2) days and 2 (1, 3) days respectively, and the difference was statistically significant (P=0.033). The peak values of ALT, which were recorded in 55 patients, ranged from 178 to 8 400 U/L, and the median value was 2 418 (922, 4 250) U/L. The peak values of AST, which were recorded in 56 patients, ranged from 165 to 17 471 U/L, and the median value was 2 658(1 205,7 250)U/L. The AST peak values of 16 patients with liver failure and 42 patients with non-liver failure were 6 195 (3 370, 6 850) U/L and 2 383 (1 115, 5 040) U/L, respectively, and the difference was statistically significant (P=0.032). Among the 59 AHI patients, 44 patients′ liver function returned to normal, 4 patients′  liver function improved, and 11 patients died, of whom 9 (81.8%) developed liver failure.ConclusionAHI induced by intravenous amiodarone is an acute onset and severe disease with a short incubation period, and should be monitored timely.
  • 临床论著
    Liang Ying;Mi Yuhong;Liu Shuang
    . 2010, 12(6): 393-4.
    Objective: To analyze the clinical characteristics of effects of pituitrin on serum sodium levels in the patients with hemoptysis. Methods: Between October 2006 and October 2009, the clinical data from the patients with hemoptysis receiving pituitrin in emergency intensive care unit(EICU) of Beijing Anzhen Hospital Affiliated to Capital Medical University were collected and retrospectively analyzed. Results: A total of 14 patients with hemoptysis received pituitrin. The initial dose of pituitrin 3-5 U in 20 mL of 0.9% sodium chloride was given by slowly intravenous push, and then pituitrin 6-12 U in 250 mL of 0.9% sodium chloride was given by intravenous infusion. After bleeding cessation, pituitrin was given in a dose of 6-12 U in 250 mL 0.9% sodium chloride by intravenous infusion, lasting 24-48 hours, and then the drug was discontinued. Four patients’bleeding ceassed after one day of pituitrin therapy, and then the drug was stopped, their serum sodium levels showed no change. Ten patients’bleeding ceased after 2-12 days of pituitrin therapy, and then the drug was withdrawal, their serum sodium levels decreased from (137.4±1.3)mmol/L(on admission) to (124.9±5.6) mmol/L (P<0.05). The ten patients comprised 4 male and 6 female with age of 47-79 years (mean age 62 years). Of them, 9 patients received pituitrin for 2-9 days(mean duration 4 days), and their mean cumulative dosage of pituitrin was 57 U(24-108 U). They presented with nausea, vomiting, dizziness and fatigue and were diagnosed with mild hyponatremia. Another patient received pituitrin for 12 days, and the cumulative dosage of pituitrin was 124 U. The patient developed torpor and lethargy, followed by transient polyuria after drug withdrawal and was diagnosed with severe hyponatremia. All patients with hyponatremia were treated with 3%- 4% sodium chloride by intravenous infusion for sodium supplement.Their serum sodium levels increased from (124.9±5.6) mmol/L to (138.1±1.2) mmol/L (P<0.05). After symptomatic treatment, all patients recovered and were discharged. Conclusion: The patients’clinical presentations and serum sodium levels should be closely monitored during treatment of hemoptysis with pituitrin. Once hyponatremia occur, pituitrin should be discontinued and the symptomatic treatment should be given.
  • 病例报告
    Zhou Meishan
    . 2010, 12(6): 437-2.
    A 3yearold boy was given one tablet of compound paracetamol and phenylephrine tablets (each tablet contains paracetamol 125 mg, phenylephrine hydrochloride 2.5 mg, chlorpheniramine maleate 1 mg, vitamin B11 mg ) thrice daily by his mother for his cold. Two days later, he developed red eruption around nose. Subsequently eruption progressed to involve his entire body, and partial eruption progressed to development of ulceration with purulent secretion, and then exfoliation occurred. Laboratory tests revealed a WBC count of 14.3×109/L with 0.086 eosinophils. The patient received symptomatic and supportive treatments for 16 days, and then his symptoms relieved.
  • 病例报告
    Qiu Xiaoyana;Qi Weilinb;Wang Dayoua
    . 2010, 12(6): 438-2.

    A 73yearold schizophrenic woman received chlorpromazine (150 mg in morning, 100 mg at night) and benzhexol (4 mg twice daily) for 30 years. Olanzapine 10 mg twice daily was added to the regimen. Two months later, the patient presented with creatine kinase elevation, acheiving a level of 15 570 U/L, and accompanied by fever, hypermyotonia, tachycardia and a pulse of 105 beats/min. Olanzapine was withdrawn and chlorpromazine and benzhexol were continued, meanwhile symptomatic and supportive treatments were given, her creatine kinase level gradually decreased close to normal level. On day 19 after drug discontinuation, the patient selfmedicated with olanzapine 10 mg once daily, the creatine kinase level increased again, acheiving a level of 700 U/L, and then normalized after drug discontinuation.

  • ADR监测
    . 1999, 1(3): 165-167.
  • 病例报告
    . 1999, 1(3): 203-203.
  • ADR监测与防治
    . 2000, 2(1): 38-40.
  • 不良事件
    . 2005, 7(2): 113-113.
  • 病例报告
    . 2003, 5(5): 291-291.
  • 病例报告
    . 2002, 4(4): 264-264.
  • 个案分析
    . 2002, 4(2): 127-128.
  • 安全用药
    . 2001, 3(2): 107-109.
  • 安全用药
    . 2001, 3(1): 34-35.
  • 病例报告
    . 2006, 8(2): 135-135.
  • 病例报告
    . 2006, 8(2): 13-134.
  • 病例报告
    . 2000, 2(3): 190-190.
  • 病例报告
    . 2004, 6(5): 337-337.
  • 病例报告
    . 2004, 6(6): 410-411.
  • Li Xueqinga;Suo Lixiab;Shao Yajunc;Yin Jinhuab
    Adverse Drug Reactions Journal. 2009, 11(3): 206-2.

    Three patients with diabetes mellitus (1 man and 2 women aged 42~65 years) received repaglinide 0.5~2 mg thrice daily. Their liver functions were normal before repaglinide administration. About 12 months of therapy, the patients presented with yellowish skin and sclera. Liver function tests revealed the following values: ALT 205~1 350 U/L, AST 183~835 U/L, γ-GT 155~585 U/L, TBil 52.8~158.8 μmol/L. Repaglinide was stopped and liver-protective treatment was given. Their symptoms subsequently improved.

  • Pan Yuyan
    Adverse Drug Reactions Journal. 2009, 11(3): 209-2.

    A 48-year-old woman with fatty liver and mild increase in liver enzyme level (ALT 54.2 U/L) was treated with tiopronin 02 g thrice daily. Eight days later, the patient developed asthenia, anorexia, and yellowish urine. Laboratory testing revealed the following values: ALT 562.1 U/L, AST 253.9 U/L, DBil 26.2 μmol/L, TBil 38.3 μmol/L. Serology tests for hepatitis A, C, D, E viruses were negative. Tiopronin was withdrawn immediately and an IV infusion of magnesium isoglycyrrhizinate and sodium deoxyribonucleotide was given. Subsequently, her liver function improved gradually. Eighteen days after discharge, her ALT was 27.1 U/L and her AST was 19.1 U/L.

  • 病例报告
    Jing Baojie;Yang Yajun
    . 2008, 10(4): 0-0.
    A 44yearold man took terbinafine 0.25 g once daily for onychomycosis. Three weeks later, the man developed fatigue, anorexia, dark urine and yellowish of sclera. Laboratory investigations revealed the following: ALT 102.7 U/L,AST 24.6 U/L,TBil 156.5 μmol/L,DBil 73.1 μmol/L. Serologic tests for hepatitis A, B, C, D, E were negative. Liver biopsy findings indicated druginduced liver damage with cholestasis. Terbinafine was stopped. He was given liverprotective treatment for about two months. His liver function improved and laboratory tests showed the following levels: ALT 51.6 U/L,AST 36.9 U/L,TBil 42.8 μmol/L,DBil 198 μmol/L. The patient was discharged after 58 days of hospitalization.
  • 不良事件
    . 2004, 6(6): 418-418.
  • 病例报告
    . 2004, 6(6): 409-409.
    A 54-year-old man was hospitalized with severe chest pain,spreading to the back and abdomen continuously for 6 hours. He was diagnosed as aortic dissection aneurysm type Ⅰ and treated with intravenous infusion of sodium nitroprusside 100mg by speed of 150μg/min.5 days later,the patient developed mild restless while his BP was 150/96mmHg.Then he was treated with intravenous infusion of sodium nitroprusside 150mg by speed of 200μg/min.His BP was 120/80mmHg, and the patient developed mania, euphoria, incoherent speech, visual and auditory hallucination, abnormal behavior and refusal of all the treatments on no purpose. The symptoms lessened after withdrawal of sodium nitroprusside for 12 hours. 24 hours later, his symptoms were resolved completely. There were no mental disorders to occurr with taking other antihypentensive drugs.
  • 病例报告
    . 2006, 8(5): 374-375.
  • 安全用药
    . 2001, 3(3): 174-175.
  • ADR监测
    . 2004, 6(4): 267-268.
  • 病例报告
    . 2001, 3(1): 49-49.
  • 病例报告
    . 2000, 2(4): 259-259.
  • 国外文献题录
    . 2003, 5(3): 204-206.
  • 病例报告
    . 2006, 8(1): 16-16.
  • 不良事件
    . 2006, 8(1): 61-61.
  • WHO信息
    . 2004, 6(2): 138-138.
  • 病例报告
    . 2002, 4(1): 28-28.
  • 病例报告
    . 2002, 4(3): 193-193.
  • 病例报告
    . 2002, 4(3): 191-191.
  • 不良事件
    . 2005, 7(2): 140-140.
  • 病例报告
    . 2000, 2(2): 120-120.
  • 病例报告
    . 2003, 5(6): 402-402.
  • 病例报告
    . 2004, 6(1): 49-49.
  • 病例报告
    . 2007, 9(2): 135-136.
  • 病例报告
    Nie Xina;Zhang Yatongb
    . 2010, 12(3): 212-2.
    A 74yearold man with gastric cancer was hospitalised for chemotherapy. The next day, he was given zolpidem tartrate 10 mg for insomnia at night. One hour later, he developed agitation, confusion, auditory hallucinations, and delirium. These symptoms did not relieved after administration of promethazine and haloperidol. Four hours later, his symptoms subsided sponancously and his consciouness recovered, however, he could not remember the prior events. The abovementioned symptoms did not reccur after the drug discontinuation.
  • 中药不良反应
    Xiao Linghui;Luo Jun
    . 2011, 13(6): 395-2.
    A 4-year-old girl with upper respiratory tract infection received Qingkailing injection, ribavirin, and energy mixture. The patient was given an IV infusion of Qingkailing injection 8 ml in 5% glucose 150 ml. About ten minutes after the infusion started, she developed skin pruritus and wheal on her palm and neck that rapidly progressed to involve her whole body, followed by pallor, short of breath, and a blood pressure of 60/30 mm Hg. The infusion was discontinued immediately. Oxygen inhalation and symptomatic treatment with epinephrine and dexamethasone were given. Her condition improved gradually and, one hour later, her vital signs were stable.
  • HE Li-en;QIU Zhi-hong;DONG Zhan-jun
    . 2013, 15(6): 356-2.
    A 72-year-old woman received an IV infusion of cefamandole 2.0 g for preventing infection after colonoscopic polypectomy. Two hours after infusion completion, the patient presented with severe abdominal pain and the symptom did not relieve after spasmolysis. At the next 11∶ 00 am, she suddenly developed hypotension (the minimum level of 80/50 mm Hg) and elevated heart rate. Treatments for raising blood pressure and supplying blood volume were given immediately. At 12∶ 30 am, an IV infusion of cefamandole 2.0 g was given again and, after infusion completion, she developed shock and a low blood pressure of 70/30 mm Hg. And she experienced gradually acute kidney injury, acute pulmonary edema, left heart dysfunction, liver damage, hypocytosis, coagulation disorders, and disseminated intravascular coagulation. The patient was admitted to intensive care unit and, after two-week resuscitation, her condition improved. Two months later, her hepatic function, coagulation function, and blood cells returned to normal except abnormal renal function ( a serum creatinine level of 165 μmol/L and a urea nitrogen level of 9.1 mmol/L ).
  • 病例报告
    ZHANG Yun-jian;WANG Xiao-fang;HU Ping;XIA Guo-guang
    . 2013, 15(2): 98-3.
    A 68-year-old man with primary hepatic carcinoma received an infusion of iopromide 30 ml for transhepatic arterial chemotherapy. About 20 minutes after completion of the infusion, the patient suddenly developed dyspnea. Physical examination showed a blood pressure of 130/76 mm Hg, a heart rate of 130 beats/min, and a saturation of pulse oximetry of 0.80. Intravenous (IV) dexamethasone 10 mg was given. Arterial blood gas analysis revealed the following levels: pH 7.31, partial pressure of carbon dioxide 34 mm Hg, and partial pressure of oxygen 69 mm Hg. Chest radiograph examination indicated multiple patchy shadows diffusing in bilateral lungs. The diagnosis of iopromide-induced noncardiogenic pulmonary edema was considered. The patient received non-invasive assisted ventilation and IV furosemide 20 mg were administered. About 12 hours later, his dyspnea was improved and oxygenation index (OI) value was 110. Thirty-six hours after therapy, he was treated with oxygen masks and the value of OI was 132. Two days later, he received oxygen inhalation through nasal tube and the value of OI was 175 and, five days later, the value of OI reached 260. About two weeks later, his dyspnea disappeared and arterial blood gas analysis revealed all the measurements were normal.
  • 病例报告
    YANG Yuan-bin
    . 2012, 14(6): 396-3.
    A 51-year-old woman with rheumatic heart disease and cerebral embolism received warfarin for about one year and the dosage was reduced gradually from 2.25 mg/d to 1.5 mg/d. At the same time, she was given tizanidine 2 mg thrice daily (2 mg twice daily at the first week)because of her right upper limb spasticity. About 20 days later, her menstruation started and lasted more than 20 days. Tizanidine was withdrawn and, 5-6 days later, her menstruation stopped. Laboratory examination showed the following results: prothrombin time 19.5 s, prothrombin activity 64.9%, prothrombin time ratio 1.56, international normalized ratio 1.61, partial thromboplastin time 37.2 s, thromboplastin time 13.5 s, fibrinogen 3.8 g/L. Warfarin was continued at the same dose as before. The situation of prolonged menstrual period and increased menstrual flow did not reccur at a one-year follow-up.
  • 病例报告
    CHEN Wen-jing;NAN Shan-ji;SONG Chun-ling;YAN Wei
    . 2013, 15(1): 48-2.
    A 51-year-old female patient with trigeminal neuralgia received carbamazepine 0.2 g thrice daily by mouth for about one year. She took carbamazepine at a cumulative dose of2 g within one day for aggravated pain. On the second day, the patient developed dizziness, blurred vision, numbness and weakness in her right extremities after taking carbamazepine 0.4 g, and then she was admitted into hospital. Physical examination showed the following results: right central facial and tongue nerve paralysis, absence of pharyngeal reflex, muscle strength of grade 4 in her right limb, hypalgesia in her right side of face and limbs. Examination of cranial magnetic resonance imaging and diffusion-weighted magnetic resonance imaging showed no abnormal changes. Carbamazepine was stopped and drug for improving circulation was given. Four days later, the patient recovered completely.
  • Zhang Fangming, Xie Cheng
    A 69-year-old male patient received oral aspirin (100 mg once daily), ticagrelor (45 mg twice daily), amlodipine besylate (5 mg once daily), losartan potassium (50 mg once daily), metoprolol sustained release tablets (47.5 mg once daily), and atorvastatin (10 mg once daily) after coronary angiography. After 28 days of treatments, ticagrelor was discontinued for economic reason and changed to clopidogrel (75 mg once daily). The next day, symmetrical erythema and needle-shaped papules appeared on skin of the abdomen and limbs, and gradually throughout the whole body. Then, mung bean-sized blisters and papulo-vesicle appeared and part of them fused into lamella with a small amount of exudation and severe itching. Two weeks later, the skin of the distal extremities thickened and the skin surface was rough and desquamated. The patient had developed 2 episodes of similar symptoms in the past. Six years ago, the similar symptoms occurred for the first time. The patient developed rashes 4 to 5 days after taking aspirin and clopidogrel after PCI. Clopidogrel was discontinued after 10 months and, half a month later, the skin symptoms completely subsided. Fourteen months ago, the similar skin symptoms occurred for the second time. Clopidogrel was given after PCI and rashes appeared 2 days later. The skin rash was relieved after anti-allergic treatments. The patient stopped taking clopidogrel herself 9 months later, the skin symptoms completely subsided half a month later. Clopidogrel-induced eczema-like drug eruption was considered. Clopidogrel was withdrawn and antihistamine, glucocorticoid, and antipruritic were given. Two weeks after drug withdrawal, the papules on the trunk were flattened and became dry, the part of the ruptured vesicles on the abdomen healed, scales of the limbs reduced, itching subsided, and no new skin lesions appeared.
  • 病例报告
    Zhang Ming;Xu Liwen;Gu Xijun
    . 2014, 16(5): 311-2.
    A 78-year-old man received intravenous infusion of ceftizoxime sodium 2.25 g once daily, oral carbamazepine 0.2 g twice daily, oral nimesulide 100 mg twice daily, intravenous infusion of dihydroxypropyl theophylline 0.5 g once daily, oral mecobalamin 0.5 mg thrice daily, intravenous infusion of dexamethasone 5 mg for one time, intramuscular injection of meperidine hydrochloride 25 mg for one time, and intramuscular injection of bucinnazine hydrochloride 100 mg for three times for postherpetic neuralgia and chronic obstructive pulmonary diseases with infection. On day 7, ceftizoxime sodium was stopped and changed to intravenous infusion of fosfomycin sodium 8 g once daily. On day 11, his blood routine examination showed the following levels: white blood cell count 1.6×109/L with neutrophils 0.03, neutrophil absolute count 0.1×109/L, and lymphocyte absolute count 0.9×109/L. All the drugs were discontinued and symptomatic and supportive treatment was given. On day 15, the level of white blood cell became 0.9×109/L with neutrophils 0.02, a absolute value of neutrophil and lymphocyte were respectively 0.1×109/L and 0.7×109/L. According to bone marrow smear histology, agranulocytosis was diagnosed. On day 17, the patient developed pneumothorax and atelectasis in the right lung. On day 20, acute respiratory failure and multiple organ failure occurred with infection and the resuscitation was unsuccessful.
  • 病例报告
    Lin Tianlai;Cai Xiaozhen;Ding Zhirong;Zeng Haiwen
    . 2014, 16(5): 309-2.
    A 76-year-old male patient received an IV infusion of micafungin 50 mg in 0.9% sodium chloride 100 ml once daily for pulmonary infection. Ninety minutes after the first infusion, the patient presented with chills, fever and dark brown urine. Laboratory testing showed the following levels: white blood cells count 25.2×109/L, hemoglobin 73 g/L, platelet count 179×109/L, blood urea nitrogen 6.4 mmol/L, serum creatinine 96 μmol/L, procalcitonin 14.13 ng/ml, prothrombin time 17 s, activated partial thromboplastin time 44 s, D-dimer 8.7 mg/L, and routine urine tests showed white blood cells (+++) , urine occult blood test (+++) , urobilinogen (+++) , urine ketones (+++), urine protein (+++) and nitrite positive. The patient was considered as acute hemolysis. Micafungin was stopped. He was given an IV injection of methylprednisolone 40 mg and hydration and urinary alkalinization. However, his urine volume was reduced from 100-150 ml/h to 10-20 ml/h in 4 hours and developed dark urine. The following day, his white blood cells count was 18.6×109/L, red cells count was 1.7×1012/L, hemoglobin was 57 g/L, platelet count was 116×109/L, reticulocytes was 0.05, albumin was 25 g/L, indirect bilirubin was 20.4 μmol/L, aspartate transaminase was 108 U/L, alanine aminotransferase was 42 U/L, blood urea nitrogen was 17.9 mmol/L, serum creatinine was 230 μmol/L, and direct antiglobulin test was positive. He was considered to have acute kidney failure. The patient received anti-infective treatment, continuous renal replacement therapy, and infusion of erythrocyte suspension and plasma. Ten days later, the patient was still anuric and presenting worsening jaundice, family members gave up treatment.
  • 病例报告
    Jiang Chengping;Li Shengqian
    . 2014, 16(1): 43-2.

    A 43-year old woman with scapulohumeral periarthritis received celecoxib 0.2 mg twice daily for 2 weeks. She developed upper abdominal persistent dull pain, distension, nausea and vomiting two hours after the last administration. Laboratory tests showed the following values: serum amylase 1 822 U/L, amylopsin 1 529 U/L, lipase 1 410 U/L, white blood cell count 12.7×109/L, neutrophils 0.74, and lym-phocytes 0.16. Abdominal ultrasound examination and magnetic resonance cholangiopancreatography showed a diffusely enlarged pancreas and fluid exudation around pancreas. The patient was diagnosed as acute pancreatitis. Celecoxib was withdrawn. Thirteen days after the therapy with jejunitas, nutritional supporting, enzyme inhibition, acid suppression, and anti-infection, her symptoms of abdominal pain and distension were disappeared. Laboratory tests showed the following values: serum amylase 86 U/L, amylopsin 48 U/L, lipase 55 U /L, white blood cell count 7.2×109/L,neutrophils 0.65, and lymphocytes 0.32. Abdominal CT showed caputpancreatis, corpora pancreatic, and pancreatic tail were located on the same level, the pancreatic shape and size were normal.

  • Li Xiaoye, Lyu Qianzhou
    . 2015, 17(5): 374.
    A 58-years-old male patient underwent stent implantation in anterior descending coronary artery in emergency angiography because of acute chest pain. After operation, aspirin 100 mg and clopidogrel 75 mg once daily were given. Two weeks later, the patient was hospitalized again due to chest pain.Coronary angiography demonstrated stent thrombosis. Thrombectomy was performed, meanwhile, thrombelastogram revealed that clopidogrel presented low reactivity. Subsequently, the daily dose of clopidogrel was adjusted to 150 mg. One month later, thrombelastogram showed adenosinediphosphate inhibition rate was within the normal range, no chest pain and other symptoms recurred at 3 months of follow-up and coronary angiography showed stent patency.
  • Li Yinghui, Hang Yongfu, Liang Yan
    . 2016, 18(1): 71.
    A 31-year-old male patient received an oral moxifloxacin 0.4 g once daily for respiratory infection and after 3 days of treatment, his symptoms were not improved and appeared urine decrease. Moxifloxacin was stopped and changed into levofloxacin 0.2 g twice daily by mouth. After 8 days of treatment, the patient′s symptoms was not improved apparently and appeared urinary protein(+), 5-10 erythrocytes/high magnification (HP), 3-5 white blood cells/HP, serum creatinine 419 μmol/L. Renal biopsy showed acute tubular interstitial nephropathy. Drug-induced acute interstitial nephritis-induced by moxifloxacin and levofloxacin was considered. Levofloxacin was stopped and an IV infusion of methylpred-nisolone 250 mg once daily was given, and 3 days later, it was changed into oral prednison 40 mg once daily. After 7 days of treatment, the patient′s blood creatinine was 168  mol/L, urea 13.6 mmol/L, glomerular filtration rate 45.8 ml/min/1.73 m2. The patient got better and was discharged. At 2 months of follow up, the patient′s blood creatinine was 119 μmol/L and urea was 6.2 mmol/L.
  • Xia Fan, Gao Jie, Xie Cheng, Ge Yongqin, Miao Liyan, Jin Zhengming
    . 2017, 19(4): 277.
    ObjectiveTo evaluate the function of "high-dose methotrexate (HD-MTX) protocol" in the patients with HD-MTX-induced acute kidney injury (AKI). MethodsThe medical record data of patients with hematological malignancy received HD-MTX therapy in the First Affiliated Hospital of Soochow University from January 2013 to December 2016 were collected and retrospectively analyzed. The patients who received chemotherapy before the establishment of "HD-MTX protocol" were enrolled into the control group (between January 2013 to September 2014), and the patients who received chemotherapy after the establishment of "HD-MTX protocol" were enrolled into the observation group (between October 2014 to December 2016). The incidence of delayed MTX elimination and AKI between the 2 groups were compared.ResultsA total of 234 patients were enrolled in the study. There were 78 patients in the control group including 50 males and 28 females with the age 3 to 64 years and median age 25 years, of them, 57 patients with leukemia and 21 patients with lymphoma. There were 156 patients in the observation group including 92 males and 64 females with the age 6 to 64 years and median age 26 years, of them, 129 patients had leukemia and 27 patients had lymphoma. The percentage of patients with no-prehydration and no-preurine alkalinization in the control group was higher than that in the observation group[60.1% (47/78) vs. 4.5% (7/156), 80.8% (63/78) vs. 8.3% (13/156)], and the median volume of intravenous hydration was less than that in the observation group[0 (0-500) ml vs. 1 750 (1 250-2 100) ml]. The differences between the 2 groups were statistically significant (χ2=91.168, P<0.001; χ2=124.415, P<0.001; Z=-9.224, P<0.001). The incidence of delayed MTX elimination and AKI after MTX infusion in the control group was higher than that in the observation group [21.8% (17/78) vs. 12.2% (18/156). 20.5% (16/78) vs. 10.3% (16/156)]. The differences between the 2 groups were statistically significant (χ2=4.300, P=0.038; χ2=4.634, P=0.031). In the control group, there were 16 patients with AKI, the patients with grade Ⅰ, grade Ⅱ and grade Ⅲ  were 6, 2 and 8 respectively. In the observation group, there were 16 patients with AKI, the patients with grade Ⅰ, grade Ⅱ  and grade Ⅲ  were 11, 4 and 1 respectively. The degree of kidney injury in the control group was higher than that in the observation group (Z=-2.286, P=0.022).ConclusionThe "HD-MTX protocol" can significantly decrease the incidence of delayed MTX elimination and AKI, especially the incidence of grade Ⅲ AKI.
  • Adverse Drug Reactions Journal. 2021, 23(6): 316-316. https://doi.org/10.3760/cma.j.cn114015-20210607-00643
  • Wu Danwei, Xing Ying, Zhen Jiancun
    . 2017, 19(4): 272.
    ObjectiveTo understand the clinical characteristics of daptomycin induced rhabdomyolysis.MethodsPubMed, Elsevier Science Direct, Embase, Springer-link, Wiley Online Library, CNKI, and Wanfang Data (to January 2017) were searched and case reports on daptomycin induced rhabdomyolysis were collected. Data related to rhabdomyolysis induced by daptomycin were analyzed descriptively. Relevance evaluation of case reports in accordance with inclusion criteria were performed. ResultsA total of 10 patients with rhabdomyolysis induced by daptomycin were collected.  Of 10 patients, 8 cases′s gender were recorded, including 3 males and 5 females. Their ages were 34 to 70 years and the average age was 54 years. There were no muscle pain or discomfort history in all patients. Daptomycin dosage in 4 patients (5~6 mg·kg-1·24 h-1) did not exceed the maximum dosage recommended in instructions; daptomycin dosage in 6 patients (7.2 mg·kg-1·48 h-1, 8 mg·kg-1·24 h-1, 6 mg·kg-1·12 h-1, 10 mg·kg-1·24 h-1 and 6.5 mg·kg-1·24 h-1) were higher than that recommended in instructions; daptomycin dosage in 1 patient was 500 mg·24 h-1 (the dosage could not be evaluated because of no body weight record). The time of rhabdomyolysis occurrence after daptomycin treatment was 2-16 days and the average time was 8 days. As the main clinical manifestations, 8 patients had myalgia, 6 patients had muscular weakness, and 2 patients had myoglobulinuria; serum CK levels were all abnormally elevated to 1 754-25 234 U/L with an average level of (13 044±8 351) U/L. Combination drugs in 9 patients were recorded; of them, the kinds of combination drugs were 1, 2, 3, 5, and 8 drugs in 2, 2, 2, 1, and 2 patients, respectively. The combination drugs included antilipemic, antibiotics, antidiabetic agents, antiviral drugs and etc. Daptomycin was stopped after rhabdomyolysis occurrence, symptomatic treatments were given; 5-18 days later, serum CK levels normalized in 4 patients, and 3-14 days later, serum CK levels decreased to some degrees (from 1 754-25 234 U/L to 125-7 647 U/L) in 5 patients; serum CK level normalized in 1 patient and the time was not mentioned. Symptoms were improved 5-14 days after daptomycin withdrawal in 3 patients and the improvement time was not mentioned in 7 patients. Relevance evaluation of adverse reactions were probably in 9 patients and possible in 1 patient.  The rhabdomyolysis occurrence was related to frequency of administration in 2 patients.ConclusionsDaptomycin alone or combined with other drugs may cause rhabdomyolysis. The frequency of administration is likely to be a risk factor. Stopping daptomycin and giving symptomatic treatments could improve symptoms and the serum CK levels may return to normal or  markedly decrease within about 2 weeks.
  • Zhang Di*, Zhou Ying, Cui Yimin, Liang Yan
    . 2015, 17(6): 453-454.
    A 52-year-old male patient with suprarenal epithelioma started to receive the targeted therapy of sunitinib (50 mg daily for 4 weeks, then at an interval of 2 weeks, six weeks for 1 cycle) one month after the right nephrectomy. Laboratory tests revealed the following results: serum creatinine 140-150 μmol/L, albumin 44-46 g, and platelet count (PLT) (129-136)×109 /L, respectively during the first 4 cycles of treatment. His serum creatinine increased to 192 μmol/L, albumin decreased to 32 g/L, and PLT decreased to 69×109 /L on the second weeks during the fifth cycle. After the end of drug use during the sixth cycle his serum creatinine increased to 284 μmol/L, albumin decreased to 25 g/L and PLT decreased to 56×109 /L. On the third week during the seventh cycle his serum creatinine, albumin and PLT were 247 μmol/L, 22 g/L and 71×109 /L, respectively. He was diagnosed as kidney injury due to sunitinib. The targeted therapy of sunitinib was stopped. The patient was suggested to visit the Division of Nephrology. According to the advice of doctor in Nephrology, the patient received the targeted therapy again 95 days later. But the dosage of sunitinib was decreased to 37.5 mg daily, the medication cycle was the same as it was before. The patient′s serum creatinine increased during the medication period and decreased during the interval according to the patient′s family member′s recounting. But the detection values were not clear. Five months later, his serum creatinine increased to 300 μmol/L, and sunitinib was stopped by himself. Two months later, the patient developed brain metastases and no longer used sunitinib.
  • Yang Shuiyuan, Wu Hong, Zeng Siyu, Tong Yanli, Mei Qinghua
    . 2015, 17(4): 306.
    A 50-year-old female patient with serious borderline tumor received chemotherapy with paclitaxel and carboplatin (an IV infusion of paclitaxel 198 mg and  carboplatin 395 mg on the first day of treatment, the cycle of treatment was 21 d) after undergoing total hysterectomy, bilateral ovarian, and greater omentum resection. After the IV infusion of third chemotherapy cycle, the patient developed persistent and progressive numbness and pain of fingers which could radiate to the elbow. After treatment with carbamazepine and mecobalamin, the symptoms were not relieved. Thus it was considered that the adverse reactions may be caused by chemotherapy drugs. So the chemotherapy was paused temporarily, and prednisone, rebamipide, mouse nerve growth factor for injection,  and mecobalamin were given. After 14 d of treatments, the patient′s symptoms were alleviated apparently. At half a year of follow-up, the patient developed slight atrophy in the right thenar muscle and hypoesthesia in bilateral index finger and middle finger palm.
  • 论著
    Zheng Jiao;Ning Ning;Yang Lijun
    . 2014, 16(4): 219-5.
    ObjectiveTo investigate the effect of puerarin on cytochrome P450 (CYP) 2D6 activity and its relationship with CYP2D6 genotypes in human.Methods(1)In vitro experiment: human liver microsomal incubation mixtures was prepared with normal liver tissues from a surgical excision of patients with introhepatic cholelithiasis; different concentrations of puerarin (0, 0.025, 0.050, 0.100, 0.200, 0.400, and 0.800 mmol/L) and metoprolol were added into the incubation mixtures and the productive rate of metoprolol metabolite (α-hydroxymetoprolol ) was detected using HPLC, which was used to access the activity of CYP2D6. (2)In vivo test: 18 male healthy volunteers with age of 19-26(22±4) years and weight of 62~75(69±7) kg were selected as the subjects. Of them, 6 patients were genotype of CYP450 2D6 *1/*1, 6 were genotype of *1/*10, and 6 were genotype of *10/*10. The test comprised 3 stages and was carried out using a two-phase crossover design. The subjects were divided into 2 groups by simple randomization method. The first stage (the 1st day to the 11th day): the subjects in one group received an IV infusion of puerarin 400 mg once daily for 10 days and the subjects in another group received nothing. All subjects received metoprolol 100 mg orally early in the morning on the 11th day. The second stage (the 12th to the 17th day): all subjects received nothing. The third stage (the 18th to the 28th day): the subjects, who received nothing in the first stage, received an IV infusion of puerarin 400 mg once daily for 10 days and the subjects in another group received nothing. All subjects received metoprolol 100 mg orally early in the morning on the 28th day. Urine was collected from 0 to 8 h after metoprolol administration on the 11th and 28th days. The concentration of metoprolol and α-hydroxymetoprolol was detected by HPLC and its ratio was used to assess CYP2D6 activity.ResultsThe results of in vitro experiment showed that α-hydroxymetoprolol levels in human liver microsomal incubation mixtures after treatment with puerarin 0, 0.025, 0.050, 0.100, 0.200, 0.400, and 0.800 mmol/L were (0.018±0.001), (0.015±0.001), (0.015±0.001), (0.012±0.001), (0.011±0.001), (0.010±0.001), and (0.005±0.002) mmol/(mg·h), respectively. The productive rate of α-hydroxymetoprolol decreased with increase of puerarin concentrations and the difference in population mean was statistically significant (F=30.750, P=0.000). The results of pairwise comparision showed that the productive rate of α-hydroxymetoprolol in the puerarin 0.100, 0.200, 0.400, and 0.800 mmol/L groups were markedly lower than those in the puerarin 0, 0.025, 0.050, 0.100, 0.200, 0.400, and 0.800 mmol/L groups (P<0.05); the productive rate of α-hydroxymetoprolol in the puerarin 0.200, 0.400, and 0.800 mmol/L groups were markedly lower than those in the puerarin 0.025 and 0.050 mmol/L groups (P<0.05); the productive rate of α-hydroxymetoprolol in the puerarin 0.800 mmol/L group was markedly lower than those in the puerarin 0.100, 0.200, and 0.400 mmol/L groups (P<005). The results of in vivo test showed that the ratios of metoprolol and α-hydroxymetoprolol in urine in the 18 subjects before and after puerarin treatment were 1.11±0.55 and 1.73±0.94, respectively. The difference was statistically significant (P<0.01). The changes of CYP2D6 activity in urine in all subjects with different CYP2D6 genotypes in the 3 groups were compared and the differences were not statistically significant.ConclusionPuerarin could inhibit the activity of CYP2D6 in a dose-dependent manner, but it is not related to the CYP2D6 genotypes.
  • Guo Hu, Huang Daoqiu
    . 2018, 20(1): 73.
    A 31-year-old female patient with rhinitis received Biyanning granule 15 g by herself. The patient developed palpitation, dyspnea, idrosis, debilitation, feeling obstruction of throat, abdominal pain, nausea, vomiting (gastric content), and decrease of blood pressure (49/30 mmHg), shortly afterwards. She developed drowsiness about 30 minutes later. She was diagnosed as anaphylactic shock due to Biyanning granule. The patient received anti anaphylactic shock treatments which included an IV infusion of 0.9% sodium chloride injection, intravenous pumping of dopamine hydrochloride injection, intravenous injection of dexamethasone sodium phosphate injection, and intramuscular injection of epinephrine for injection. About 50 minutes later, her blood pressure increased to 80/57 mmHg. Two hours later, the above-metioned symptoms relieved, blood presure fluctuated between 90-100/60-80 mmHg. Twelve hours later, the symptoms disappeared, blood pressure was 106/66 mmHg.
  • Yao Wenxin, Liu Wei, Liu Zhijun
    Adverse Drug Reactions Journal. 2019, 21(4): 285-289. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.008
    The traditional concept was that combination of 2 or more kinds of drugs with higher plasma-protein binding degree might increase the free concentration of 1 or more of the drugs due to their competition for plasma-protein binding, which eventually might enhance the efficacy and toxicity of the drugs. But in the clinical practice, the combination of drugs with higher plasma usually did not develop so many serious drug interactions protein binding degree. It was demonstrated from the following 4 aspects in this article that combination of drugs with higher plasma-protein binding degree was less likely to result in clinically significant interactions due to competition for plasma protein binding: (1) the amount of proteins that could bind to drugs in plasma was greater than that of the drug molecules; (2) apparent drug volume of distribution (Vd); (3) plasma clearance rate of drug; (4) area under plasma concentration-time curve. It was necessary to re-recognize the inherent concept above-mentioned.
  • Ouyang Cuiwen, Liu Xiaoqi, Zhang Xiaojuan, Zhong Shilong
    Adverse Drug Reactions Journal. 2021, 23(4): 214-216. https://doi.org/10.3760/cma.j.cn114015-20201020-01059
    A 79-year-old male patient with diabetes mellitus was given tolvaptan (15-mg orally once daily) combined with furosemide, levosimendan, and recombinant human brain natriuretic peptide for heart failure 7 years after coronary artery bypass grafting and clopidogrel, metoprolol, ezetimibe, insulin glargine, and liraglutide were given concomitantly for coronary atherosclerotic heart disease and diabetes mellitus. Three days later, his heart failure symptoms were improved, but he developed hypernatremia. His blood sodium rised from 136-mmol/L on admission to 152-mmol/L. After stopping tolvaptan, the serum sodium level continued to rise, with a peak value of 168-mmol/L. After relaxing his water intake restriction, serum sodium gradually decreased to 160-mmol/L. On the 4th day of drug withdrawal, dapagliflozin (5-mg orally once daily) was added; on the 5th day, the blood sodium was 146-mmol/L.
  • 病例报告
    Jia Hai;Chu Yanqi;Li Wei;Yuan Jiyong
    . 2011, 13(5): 321-2.

    A 57-year-old male patient received urokinase 200 000 U via pump every six hours and heparin sodium 12 500 U in 0.9% chloride sodium 50 ml via minipump for 24 hours for thrombolytic therapy. In same day, the platelet level was 126×109/L and, on day 3 and 4, the platelet count respectively decreased to 99×109/L and 65×109/L. Heparin-induced thrombocytopenia was considered. Heparin sodium was stopped and switched to argatroban. The patient then underwent the second thrombolytic therapy with urokinase. The platelet count increased at once after heparin sodium discontinuation and, on days 2 and 4, his platelet level was 93×109/L and 113×109/L, respectively. His platelet count returned to a baseline level on day 5.

  • 病例报告
    Lü Yanan
    . 2011, 13(4): 258-1.

    A 52-year-old woman with acute tonsillitis took oral levofloxacin 0.2 g trice daily. Three days later, the patient developed urinary urgency, urinary frequency, hypogastrium pain, brown urine with blood clot accompanied by dysuria. Laboratory tests showed occult blood (+++) and ultrasonography revealed acute cystitis. Levofloxacin was stopped. On day 2 after drug discontinuation, urine color normalised and, on day 5, routine urine tests were normal. Two weeks later, ultrasonography showed her bladder was normal.

  • 病例报告
    Wang Hujun;Xu Yang
    . 2011, 13(4): 251-2.

    A 52-year-old female patient himself took azithromycin 0.5 g once daily for upper respiratory tract infections. Three days later, the patient developed smell and taste disorders. Azithromycin was discontinued immediately. However, two weeks after cessation of the drug, her sense of smell and taste still did not return.

  • 病例报告
    . 2007, 9(2): 140-141.
  • 病例报告
    . 2003, 5(6): 409-409.
  • 综合报道
    . 2001, 3(2): 111-113.
  • 病例报告
    . 2001, 3(2): 139-139.
  • 病例报告
    . 2003, 5(4): 250-250.
  • 药物评介
    . 2001, 3(1): 60-61.
  • 病例报告
    . 2002, 4(1): 49-49.
  • 病例报告
    . 2003, 5(3): 188-189.
  • 病例报告
    . 2004, 6(2): 122-123.
  • 病例报告
    . 2006, 8(5): 384-384.
  • 病例报告
    . 2006, 8(4): 298-299.
  • 药物误用
    Zhang Qionga;Li Huiqinb;Wang Peimina
    . 2009, 11(2): 120-2.
    A 46yearold woman with nasopharyngeal carcinoma had received radiotherapy and chemotherapy for four years and more. After hospitalization, she received chemotherapy with paclitaxel and oxaliplatin. On day 2 after chemotherapy completion, SC filgrastim 200 μg was given for preventing chemotherapyinduced neutropenia. About 30 minutes after administration, the patient suddenly experienced dizziness, dyspnea, palpation, chest distress, nausea, vomiting, and shiver. Physical examination revealed the following: pulse rate 87 beats/min, respiratory rate 28 breaths/min, BP 80/53 mm Hg, and SPO2 0.94. Oxygen inhalation therapy, IM diphenhydramine, and IV push of dexamethasone, IM metoclopramide, an IV infusion of dopamine were given immediately. After 20 minutes, a repeated examination revealed the following: pulse rate 73 beats/min, respiratory rate 23 breaths/min, BP 101/64 mm Hg, and SPO2 0.99. One hour later, her symptoms relieved. A review of her medical history showed that she had developed anaphylactic shock after subcutaneous injection of filgrastim four years earlier.
  • 病例报告
    Wang Xiaotaoa;Liu Zaifua;Peng Zhanrongb
    . 2008, 10(2): 144-2.

    A 65yearold man with hepatitis B was hospitalized with cirrhosis (decompensate period) and ascites. He was infused with hepatocyte growth promoting factors 80 mg dissolved in 100 ml of glucose 5% intravenously. Two minutes later, the man developed cyanosis involving the face and lips, severe dyspnea, highpitched laryngeal stridor, and a three concave sign in inspiration. The infusion was discontinued, but other drugs were continued. The patient received corticosteroids and oxygen therapy. Twenty minutes later, his symptoms disappeared.

  • 病例报告
    . 2002, 4(3): 196-197.
  • 不良事件
    . 2004, 6(6): 420-420.
  • 网络医药
    . 2003, 5(4): 256-258.
  • 病例报告
    . 2004, 6(6): 411-412.
  • 不良事件
    . 2004, 6(6): 414-414.
  • 病例报告
    . 2006, 8(1): 32-32.
  • 病例报告
    . 2001, 3(2): 117-118.
  • 病例报告
    . 2004, 6(1): 8-8.
  • 病例报告
    . 2004, 6(3): 176-176.
  • 病例报告
    . 2005, 7(3): 209-209.
  • 病例报告
    . 2005, 7(1): 22-22.
  • 中药不良反应
    . 2007, 9(2): 144-145.
  • 安全信息
    . 2007, 9(4): 302-302.
  • 中毒救治
    Li An;Sun Limei;Wang Dixin
    . 2010, 12(2): 120-2.
    A 46-year-old man received one Chinese herbal medicine pill prepared by a clinic ( each pill contained approximately 21 mg of calomel ) twice daily and he took 13 pills in total. On day 7, the patient developed dizziness, chest distress, and mouth ulcer accompanied by fever and generalized pain. His symptoms exacerbated and he was hospitalized. His temperature was 37.2℃. Physical examination showed congested erythema, which faded when pressed, in both face and trunk skin and oralmucosal congestion, as well as gingival swelling. Laboratory tests revealed the following levels: blood mercury 0.029 mg/L, urine mercury 39.565 μmol/molCr, ALT 61 U/L, AST 28 U/L, BUN 7.42 mmol/L, SCr 67.0 μmol/L, blood β2-microglobulin 1 549.20 ng/mL, urine β2-microglobulin 167.0 ng/mL. Unithiol therapy was given. His condition improved, and urine mercury tended to normal. On reexamination, his liver functions, blood and urine β2-microglobulin levels returned to within normal range.
  • 病例报告
    Xiong Xiaodong;Hu Yongfang
    . 2011, 13(5): 319-3.

    A 68-year-old woman with infective endocarditis received linezolid 0.6 g twice daily orally. A half month later, she developed asthenia and lassitude. Routine blood tests showed a WBC count of 4.18×109/L,a RBC count of 3.23×1012/L,a Hb level of 76 g/L,and a PLT count of 40×109/L. Linezolid was withdrawn. Eleven days later, her hemogram result returned to normal, she was retreated with oral linezolid 0.6 g twice daily. After 14 days of therapy, repeat routine blood tests showed the following values: WBC count 3.50×109/L,RBC count 2.51×1012/L,Hb 71.0 g/L, and PLT count 36×109/L. Linezolid was withdrawn again. After drug withdrawal, the patient developed fever lasting for five days (peak temperature 38.5 ℃) accompanied by cough, yellow sputum and stuffy nose and he was then hospitalized. After hospitalization, the patient received 3 transfusions of concentrated red blood cells 400 ml. Routine blood tests showed the following values: WBC count 5.90×109/L,RBC count 3.33×1012/L,Hb 95 g/L and PLT count 158×109/L. On hospital day 21, the patient received IV linezolid 0.6 g twice daily. On hospital day 36, routine blood tests showed a WBC count of 2.30×109/L,a RBC count of 2.21×1012/L, a Hb level of 61 g/L, and a PLT count of 29×109/L. Linezolid was withdrawn again. Three transfusions of red cell suspension 400 ml were given with SC recombinant human granulocyte-colony stimulating factor 150 μg/day for 4 days. Subsequently, the patient was discharged at her request.

  • 病例报告
    Zhao Xia;Li Yan;Xu Wei;Han Yi
    . 2014, 16(3): 183-2.
    A 63-year-old woman with colon cancer was treated with a chemotherapy consisting of irinotecan and oxaliplatin. She was given irinotecan 200 mg plus oxaliplatin 200 mg by subclavian vein intubation on the first day, and irinotecan 160 mg on the 8th day. On day 7, the patient developed yellow stools. The chemotherapy discontinued. Drugs for protection of intestinal mucosa and antidiarrheal agent were given. On day 8 night, she had a fever. The temperature was 38.0 ℃. Laboratory tests showed the following values: WBC count 0.27×109/L,platelet count 117×109/L. Anti-infection therapy was given. On day 14, the severe watery stool appeared again, laboratory tests showed following values: serum potassium 2.26 mmol/L, sodium 126 mmol/L. She received the therapies for infection control and correcting electrolyte imbalance. On day 16, the patient presented persistent fever, severe abdominal distension with intestinal paralysis. Laboratory tests showed following values: WBC count 0.25×109/L,platelet count 25×109/L. She was given imipenem and cilastatin sodium and octreotide. On day 18, her blood pressure decreased to 70/40 mmHg, blood oxygen saturation was not monitored. She was in a coma. On day 19, the patient died despite all rescue measures.
  • Li Longkuan, Xie Juan
    . 2015, 17(6): 436-439.
    Valproic acid is metabolized via β-oxidation in the body and produces 2-propyl-2-pentenoic acid (2-ene-VPA) which has antiepileptic activity and sedation but also has certain hepatotoxicity and neurotoxicity. 2-ene-VPA is eliminated slowly than VPA and has a high binding protein as to VPA. Hepatotoxicity of 2-ene-VPA is lesser than VPA but also can interfere with the normal oxidation of fatty acid. The valproic acid-induced hyperammonemic encephalopathy may refer to the accumulation of 2-ene-VPA in brain. The pharmacological action and safety of 2-ene-VPA need more pre-clinical evaluation.
  • Liu Xiaoqi, Yang Min
    . 2015, 17(2): 121-125.
    ObjectiveTo explore the clinical characteristics and prognosis in patients with interstitial lung disease (ILD) induced by gefitinib or erlotinib.Methods"Epidermal growth factor receptor tyrosine kinase inhibitors" "gefitinib" "erlotinib" "interstitial lung disease" "case report", and corresponding Chinese vocabularies were selected as key words and PubMed, MEDLINE, Web of Science, CNKI, Wanfang databases, VIP and CBMdisc from January 2001 to April 2014 were searched. The case reports of ILD induced by gefitinib or erlotinib were collected, the patients′ age, sex, pathologic diagnosis and staging, anamnesis, history of treatment, ILD occurrence time, clinical manifestations, treatments and outcome were recorded. ResultsA total of 40 reports involving 60 patients were entered. Fifty-nine cases were diagnosed as non-small cell lung cancer. Thirty-five (58.3%) patients were treated with gefitinib, 34 of them were given 250mg/d and one was given 500 mg/d. Twenty-five (41.7%) cases were treated with erlotinib 150 mg/d. The shortest occurrence time of ILD was one day after medication, the longest time was 210 days after medication. Thirty-three (55.0%) patients developed ILD during 7-28 days after medication. The major clinical manifestations of ILD due to gefitinib and erlotinib were dyspnea, cough and fever. Ten (16.7%), 2 (3.3%) and 2 (3.3%) cases  developed erythra, diarrhea and liver injury at the same time, respectively. The patients who were diagnosed as ILD were withdrawn immediately and treated with symptomatic and harmonic therapy. Thirty patients' clinical symptom and imaging features were improved 3-90 days (median 10 days) later. Thirty patients died 1-80 days (median 6 days) later. The patients who were diagnosed as ILD in less than 7 days after medication, had history of pulmonary fibrosis or radiation pneumonitis, and developed liver injury meanwhile (4, 2, 2, respectively) died.ConclusionsThe median time of ILD induced by gefitinib or erlotinib was 24 days (1-210 days). The major clinical manifestations of ILD were dyspnea, cough and fever. The prognosis was poor in patients who were diagnosed as ILD within 7 days after medication, had history of pulmonary fibrosis or radiation pneumonitis, and developed liver injury meanwhile.
  • Chen Jing
    . 2017, 19(2): 134-135.
    A 3 year-old girl with acute bronchitis received budesonide nebulising suspension 2 ml and terbutaline sulphate solution for nebulization 1 ml twice daily. After 3 days of treatment, the girl′s symptoms of cough and asthma were not improved. The laboratory test showed the following values: fasting blood-glucose 6.2 mmol/L, urine ketone bodies positive. It was told by her parents that the girl ever been used budesonide nebulising suspension and ipratropium bromide solution for inhalation to treat cough with good curative effect with no adverse reactions. It was considered that the increased blood glucose and the positive of urine ketone body were correlated to terbutaline sulfate. Terbutaline sulfate solution for nebulization was stopped, and changed to ipratropium bromide 1.25 ml and budesonide nebulising suspension 2 ml twice daily. Three days later, the gril′s symptoms of cough and shortness of breath disappeared, the laboratory test showed the following values: fasting blood-glucose 6.1 mmol/L, urine ketone bodies positive. The results of reexamination one month later showed fasting blood-glucose 5.1 mmol/L, urine ketone bodies negative.
  • Li Jianwei, Yang Rui
    Adverse Drug Reactions Journal. 2023, 25(3): 187-189. https://doi.org/10.3760/cma.j.cn114015-20220411-00303
    A 32-year-old male patient with community-acquired pneumonia received levofloxacin hydrochloride injection 0.6 g by intravenous infusion once daily. About 30-minutes after the first medication, the patient developed blister-like red rash on the palms of both hands and pelma of both feet. Considering that it was related to levofloxacin hydrochloride injection, the drug was discontinued and an IV infusion of dexamethasone sodium phosphate injection 5-mg was given. On the second day, the patient′s body temperature was 39.8-℃, the rash and itching symptoms were aggravated, scattered erythematous rash appeared on his face, chest and back, both upper and lower limbs, and erosion and ulcer appeared on the mucous membranes of the mouth, eyes and vulva. The patient was diagnosed as having Stevens-Johnson syndrome. Anti-inflammatory and anti-allergic treatments such as methylprednisolone, calcium gluconate, ganciclovir, imipenem and cilastatin sodium, pantoprazole, as well as symptomatic and supportive treatments such as mucosal repair, nutritional support, skin care, etc. were given. Seven days later, the patient′s temperature returned to normal; 7 days later, many blister-like red skin rashes on the trunk became pale and collapsed; 24 days later, new skin could be seen on the hands and feet of the patient, the erythematous rash on the chest and back was subsided, and the mucosa of the mouth and vulva was well healed.
  • Liao Ziqiong, Dong Shujie, Zhao Rongsheng
    Adverse Drug Reactions Journal. 2024, 26(4): 251-253. https://doi.org/10.3760/cma.j.cn114015-20240311-00148
    A 63-year-old female patient with multiple systemic metastases from lung adeno- carcinoma was treated with befotertinib (75-mg orally once daily) and other symptomatic supportive treatments. Before treatments, her platelet count (PLT) was 177×109/L. After 35 days of medication, the patient had a transient loss of consciousness with chest tightness and shortness of breath. Computed tomography pulmonary angiography showed multiple embolism in bilateral pulmonary arteries. Laboratory tests showed that D-dimer was 35.16-g/L, and PLT was 34×109/L. The pulmonary embolism and throm- bocytopenia were considered to be caused possibly by befotertinib. Befotertinib was stopped, and enoxaparin sodium injection and rivaroxaban were given successively for anticoagulation. Thirteen days later, the chest tightness and shortness of breath were significantly improved, D-dimer was 0.57-g/L, and the PLT was 123×109/L.
  • Lu Jin, Zhan Guanjun, Xu Jiabing, Meng Zhongjing, Li Nini, Liu Zhongqiu, Hu Linlin
    Adverse Drug Reactions Journal. 2024, 26(10): 608-614. https://doi.org/10.3760/cma.j.cn114015-20240126-00067
    Objective To explore the clinical characteristics of tigecycline-associated hypofibrinogenemia in critically ill patients, and analyze risk factors for its occurrence. Methods Clinical data of patients treated with tigecycline in the Intensive Care Unit (ICU) at Zhongda Hospital Affiliated to Southeast University from January 2021 to December 2022 were collected and retrospectively analyzed. Patients were divided into hypofibrinogenemia group and non-hypofibrinogenemia group according to their fibrinogen levels. General information, laboratory tests results, tigecycline application, combined drugs, and blood concentration of tigecycline were compared between the 2 groups. Variables with P<0.10 in intergroup comparisons were included in a multivariate logistic regression model to analyze the risk factors for tigecycline-associated hypofibrinogenemia, and odds ratios (OR) and its 95% confidence intervals (CI) were calculated. Results A total of 79 patients using tigecycline were collected, including 43 cases with hypofibrinogenemia and 36 cases without hypofibrinogenemia. Univariate analysis showed that the differences in patients with diabetes [41.9%(18/43) vs. 16.7%(6/36)], acute kidney injury [41.9%(18/43) vs. 19.4%(15/36)], and baseline fibrinogen (before tigecycline treatment) ≤4 g/L [37.2%(16/43) vs. 16.7%(6/36)] between the 2 groups were statistically significant (all P<0.05). The related factors (P<0.10) of the 2 groups, including diabetes, acute renal injury, continuous renal replacement therapy, baseline FIB ≤4 g/L (before using tigecycline), larger total dose of tegacycline and longer treatment duration, were included in the multivariate logistic regression analysis. The results showed that diabetes (OR=4.851, 95%CI: 1.180-19.494, P=0.029), continuous renal replacement therapy (OR=8.610, 95%CI: 1.987-37.311, P=0.004), and longer treatment duration (OR=1.452, 95%CI: 1.018-2.071, P=0.040) were independent risk factors for tigecycline-related hypofibrinogenemia. Conclusion In critically ill patients, with diabetes, continuous renal replacement therapy, and longer treatment duration of tigecycline may increase the risk of hypofibrinogenemia.
  • Xie Yajun, Zhao Bei, Li Shixing, Li Xiaoye, Shi Ning
    Adverse Drug Reactions Journal. 2024, 26(9): 574-576. https://doi.org/10.3760/cma.j.cn114015-20240509-00321
    A 61-year-old male patient with coronary heart disease was treated with dual antiplatelet therapy, lipid-lowering therapy (atorvastatin) and other symptomatic drugs after coronary interventions. Because the patient was at ultra-high-risk of cardiovascular events, had multiple in-stent restenosis, and had uncontrolled blood lipids, subcutaneous injection of evolocumab 140?mg was added once every 2 weeks. The platelet count (PLT) of the patient was within the reference range before evolocumab application. After 2 injections of evolocumab, he developed bloody sputum, blood blisters on the lips and scattered bleeding points around the body, with PLT 19×109/L. The dual antiplatelet therapy and evolocumab were suspended, but the bleeding was aggravated. According to the results of bone marrow puncture and biopsy, the patient was diagnosed with idiopathic thrombocytopenic purpura. Glucocorticoid, human immunoglobulin, recombinant human thrombopoietin and platelet transfusion were given but not effective. Subsequently, herombopag was added and PLT gradually increased. After 25 days, the PLT was 109×109/L.
  • Huang Nianxu, Lu Jin
    . 2016, 18(3): 215.
    A 59-year-old female patient with type 2 diabetes mellitus was treated with metformin 0.5 g thrice daily. Vildagliptin 50 mg twice daily was added to her regimen due to poor control of her diseases. Four weeks later, the patient developed acute abdominal pain. Laboratory tests showed the following values: serum amylase 588 U/L, lipase 1 226 U/L. Abdominal ultrasound showed a small amount of peritoneal fluid around the pancreas. Acute pancreatitis was diagnosed. Vildagliptin and metformin were stopped. Fluid infusion, anti-infection therapy, acid suppression therapy, and nutritional support therapy were given. On day 9, the abdominal pain disappeared, the serum amylase was 64 U/L, and the lipase was 102 U/L.
  • Su Na, Wei Chunyan, Xu Ting
    Adverse Drug Reactions Journal. 2015, 17(2): 104-111.
    To evaluate the safety of liraglutide treatment in patients with obesity or overweight.MethodsLiraglutide, overweight, obesity, weight loss, and glucagon-like peptide-1 were selected as the key words and the Cochrane Library, PubMed, Medline, Embase, VIP, CNKI, and WanFang databases were searched. Randomized controlled trails (RCT) of liraglutide treatment for obesity or overweight were selected and the Meta-analysis were performed using RevMan 5.3.0 software. The safety were evaluated by the incidence of common (mild hypoglycaemia, nausea, diarrhea, headache, nasopharyngitis) and serious adverse drug reactions (severe hypoglycaemia, gastrointestinal reactions, and pancreatitis).ResultsA total of 12 RCTs and 3 260 patients with overweight or obesity (2 956 and 664 patients respectively) were entered in this study. The treatment course was 8-56 weeks. The results of the incidence of common adverse drug reactions were as follows. The difference of the incidence of common adverse drug reactions in the liraglutide group [75.6% (436/577)]and the placebo group [68.5% (316/461)] was statistically significant [relative risk (RR)=1.37, 95% confidence interval (CI): 1.02-1.86, P=0.04], the difference between the liraglutide group [74.9% (176/235)]and the exenatide group [78.8% (183/232)] was not statistically significant (P=0.31), the difference between the liraglutide group [57.1% (24/42)]and the insulin group [75.6% (436/577)] was statistically significant (P<0.01), the difference between the liraglutide group [92.7%(228/246)]and the glimepiride group [57.1%(24/42)] was statistically significant (P<0.01). The incidence of mild hypoglycaemia in the liraglutide group was higher than that in the placebo group [17.7% (82/464) vs. 9.6%(22/228)], lower than that in the insulin group [7.5% (7/94) vs. 21.2% (21/99) ] and in the glimepiride group [8.1% (20/246) vs. 24.2% (60/248)], and the incidence of diarrhea in the liraglutide group was higher than that in the glimepiride group [18.7% (46/246) vs. 8.9% (22/248)] (P<0.01 for all comparisons). The incidences of the serious adverse events were 4.3% (13/302) in the liraglutide group and 2.0% (6/308) in the placebo group (RR=2.19, 95%CI: 0.85-5.68, P=0.11), 5.1% (12/235) in the liraglutide group and 2.6% (6/232) in the exenatide group. There were no statistically significant differences (P=0.17). One patient in the liraglutide group died of pancreatitis and 9 patients stopped treatment because of serious gastrointestinal reactions.ConclusionThe safety of liraglutide treatment is slightly inferior to that of insulin and glimepiride, but the patients′ tolerance to liraglutide is good.
  • Lu Yu, Ma Delin, Yu Xuefeng
    . 2015, 17(2): 138-141.
    Rosiglitazone and pioglitazone belong to thiazolidinediones (TZD) insulin sensitizers, mainly used for the treatment of type 2 diabetes. Rosiglitazone was restricted to use or withdrawn from the market due to possibly increased cardiovascular events in 2010, and then was released for insufficient evidence in 2013. The large prospective clinical trial and Meta-analysis indicated that pioglitazone has cardiovascular protective effect, since the drug reduced risk of myocardial infarction/stroke/death of patients with type 2 diabetes. The different cardiovascular risk of rosiglitazone and pioglitazone maybe related to the differences in effect on lipid metabolism or in gene regulation.
  • 病例报告
    Lu Min;Zhou Ying;Cui Yimin;Bai Wenpei
    . 2014, 16(3): 177-2.
    A 41-year-old female patient received tripterygium glycosides 20 mg thrice daily, prednisone 20 mg once daily, valsartan 80 mg once daily, amlodipine besylate 5 mg once daily, calcium carbonate 750 mg thrice daily and calcitriol 0.25 μg once daily for glomerulonephritis and renal hypertension. Tripterygium glycosides and prednisone had to discontinue because the patients developed amenorrhea about one month after the therapy, and amenorrhea has lasted for five months. The sex hormone levels were measured as follows: luteinizing hormone 29 U/L, follicle-stimulating hormone 7 U/L, estradiol 1 168 pmol/L, prolactin 0.02 nmol/L, testosterone 0.12 nmol/L; progesterone 1.5 nmol/L. Hormone replacement therapy with dydrogesterone 10 mg twice daily for 10 days was given. Her menstruation started on day 4 after dydrogesterone discontinuation and lasted for 5 days. The regular menstrual cycle has been restored.
  • 病例报告
    Gao Jie;Hang Yongfu;Xie Cheng;Zheng Xiaoxian
    . 2014, 16(2): 125-2.

    A 13-year-old boy (weighing 24 kg) after allogeneic transplantation due to acute lymphoblastic leukemia received an IV infusion of azithromycin at a dose of 20.8 mg/kg because of pneumonia. At the end of intravenous infusion of azithromycin for the first time, the boy developed palpitation and the heart rate was 225 beats/min, blood pressure 75/45 mmHg, and oxygen saturation 0.98. The ECG examination showed supraventricular tachycardia and narrow QRS complex. The bedside echocardiographic examination showed a small amount of pericardial effusion,slight decrease of the motion range of left ventricular posterior wall, and ejection fraction 0.58. Azithromycin was discontinued immediately and his carotid sinus and eyeball were pressed alternately. About 10 minutes later, his heart rate dropped to 120 beats/min, sinus rhythm recovered, and blood pressure was 92/62 mmHg. Two days later, his ECG examination showed normal and his heart rate was 87 beats/min.

  • Han Peng, Zhu Shenyin
    Drug-induced peripheral neuropathy (DIPN) is a disease caused by drug′s direct or indirect damage on the structure or function of peripheral nerve. The main clinical characteristics are the dysfunctions of sensory, motor and autonomic nerves in the area of the affected nerves. The sensory nerve abnormality includes paresthesia, burning sensation, and tactile sensitivity reduction. The motor nerve abnormality includes limited mobility, and weakened or disappeared deep tendinous reflect. The autonomic nervous′ symptoms include constipation, abdominal pain, frequent micturition, and sexual dysfunction. The mechanism of DIPN includes the drug′s direct injury on the peripheral nerves, the immune-mediated nerve injury and the inflammatory damage of the neurotrophic vessels. The pathological nerve fibers show that the changes of segmental demyelination, axonal degeneration, dense granule and vacuole. The results of neuroelectrophysiological examinations show that the decrease of the amplitude and conduction velocity of sensory nerve action potential, and the normal or light change of the amplitude and conduction velocity of motor nerve action potential. The diagnosis of DIPN are mainly on the basis of the history of drug exposure, clinical characteristics and the results of neuroelectrophysiological examination. The causality between the drugs and the peripheral neuropathy is evaluated by Naranjo. The treatment of DIPN includes drug withdrawal or decreasing of the dosages of suspected drugs, taking anticonvulsants, antidepressants or opioid drugs, local anesthetics, and lipophilic antioxidants-zinc sulfate at the same time.
  • 病例报告
    Li Tingting;Liu Haiyan
    . 2011, 13(4): 245-1.

    A 72-year-old male patient received an IV infusion of cefoperazone/tazobactam 2 g in 5% glucose 250 ml twice daily for 8 days, an IV infusion of bromhexine 4 mg twice daily for 15 days, oral aminophylline 0.1 g every 8 hours for 17 days, and two chewable tablets of montelukast sodium 10 mg every night for 16 days for acute exacerbations of chronic bronchitis. On day 17, the patient presented with upper limb tremor, especially in fingers. His symptoms was considered to be produced by montelukast sodium chewable tablets and did not recur after drug discontinuation.

  • 病例报告
    Sun Jian;Liu Peng;Fu Dexing;Liu Zhijun
    . 2011, 13(2): 121-2.
    A 75yearold male patient with prostatic carcinoma received carbamazepine 0.1 g twice daily for postherpetic neuralgia. Two days later, he experienced a weak urine stream, disabling frequent urination, and stuttering urination. Five days later, carbamazepine was increased to 0.2 g twice daily. His dysuria aggravated, and then his urine was drained using a urinary catheter. The drug was discontinued. The next day, the patient urinated himself and, on day 5, he recovered completely.
  • 病例报告
    Zhang Songzhen;Wang Jimei
    . 2010, 12(4): 268-2.
    A 48yearold woman with intervertebral disk hernia and right arm pain received an IV infusion of ceftriaxone sodium 3 g once daily, dispersible nimesulide 0.1 g,twice daily and 2 compound chlorzoxazone tablets, three times daily. Five days later, the patient presented with nausea, vomiting and abdominal pain. Ceftriaxone sodium was discontinued. She was given mosapride and weiyankeli for 4 days with no improvement. The patient was hospitalized for abdominal pain. Abdominal ultrasonography showed 1.8 cm×0.9 cm echo-dense sand-like calculi in her gallbladder. No intra- or extrahapatic bile duct dilatation was seen. Cholecystolithiasis was considered to be related to ceftriaxone sodium. The patient received symptomatic treatment of antacid and spasmolysis. After seven days of the treatment, her calculi decreased in size and then she was discharged. One month later, no calculi were detected on repeat ultrasound examination.
  • 病例报告
    LIU Qing;LUO Gang;LEI Zhao-bao
    . 2012, 14(5): 323-2.
    An 87 year-old male patient received an IV infusion of fluconazole 0.4g once daily for chronic obstructive pulmonary disease (COPD) and Candida albicans infection. The patient experienced agitation, anxiety, delirium, and trembling of his hands at the night. On day 3, the dose of fluconazole reduced to 0.2 g once daily, and a antipsychotic medication was given. But the patient’s mental symptoms was progressively exacerbated. On the day 5, fluconazole was discontinued, and itraconazole capsules were given orally. The patient’s mental symptoms disappeared. On days 8 and 10, sputum cultures results were negative, and the symptoms of COPD was relieved. The patient’s mental symptoms did not reappear on telephone follow-up at 15 days after discharge.
  • 病例报告
    TANG Mao-xing;XIA Shu
    . 2012, 14(4): 240-3.
    A fifty-year-old male patient undergoing stomach cancer surgery received three tegafur, gimeracil and oteracil potassium capsules (each capsule contains tegafur 20 mg,gimeracil 5.8 mg, and oteracil potassium 19.6 mg) twice daily postoperatively. Three days later, the patient developed dizziness, asthenia, dark urine, and severe yellowing of his skin and sclera. Laboratory examinations showed the following levels and values: WBC count 2.2×109/L with neutrophils 0.79, RBC count 2.6×1012/L, hemoglobin 79 g/L, total bilirubin(TBil) 120.7 μmol/L, direct bilirubin(DBil) 27.2 μmol/L. Tegafur,gimeracil and oteracil potassium capsules were stopped immediately and he received treatment with drugs to protect liver and medications to stimulate white blood cell production for 2 days. But skin and scleral yellowing progressively worsened. Laboratory examinations revealed the following levels and values: WBC count 17.6×109/L with neutrophils 0.88, RBC count 1.0×1012/L, hemoglobin 32 g/L, hematocrit(HCT) 0.10, TBil 140.4 μmol/L, DBil 43.9 μmol/L. A transfusion of washed red blood cells and symptomatic treatment with dexamethasone, human immunoglobulin, and other medications were given. The ratio of glucose-6-phosphate dehydrogenase (G6PD)/ 6-phosphate glucose acid dehydrogenase was 0.36. Acute hemolytic anemia was considered to be produced by G6PD deficiency. The transfusion of washed red blood cells was continued and dexamethasone was tapered and discontinued and human immunoglobulin was also withdrawn. His anemia gradually improved. Nine days after tegafur,gimeracil and oteracil potassium capsules withdrawal, his dizziness and asthenia basically resolved and mild jaundice of his skin and sclera remained. Laboratory tests showed a WBC count of 3.3×109/L with neutrophils 0.77, a RBC count of 2.6×1012/L, a hemoglobin level of 82 g/L, and a HCT level of 0.24. The patient was discharged at the same day. Four days after discharge, his routine blood tests and other examinations were repeated at a local hospital and the results basically returned to normal.
  • 病例报告
    HE Zhong-fang;ZHENG Mao-hua;WU Xin-an;XU Ji-guang;LUO Yi-cheng
    . 2012, 14(5): 308-2.
    A 46-year-old woman received an IV infusion of piperacillin sodium/tazobactam sodium 4.5g every 8 hours for postoperative intracranial infection . Her WBC count decreased from 10.61×109/L before treatment to 1.79×109/L on day 13 of treatment and 1.00×109/L on day 15 of treatment, respectively. Piperacillin/tazobactam was withdrawn immediately and switched to other antibacterial drugs, and then hypodermic recombinant human granulocyte macrophage colony stimulating factor(rhGM-CSF)150 μg once daily was given. Four days after the treatment changes, her WBC count increased to 6.95×109/L. Six days after the treatment changes, her cerebrospinal fluid WBC count increased from 8×106/L(15 days after the first administration) to 56×106/L, she was readministered an IV infusion of piperacillin /tazobactam 4.5 g every 8 hours and her rhGM-CSF dosage remained unchanged. After a 6-day treatment, her intracranial infection was cured, antibacterial drugs were stopped.On days 2 and 5 of treatment, her WBC count was 2.67×109/L and 1.65×109/L, respectively. On day 8, rhGM-CS was withdrawn and WBC count was 5.75×109/L. On day 15, WBC count was 4.56×109/L.
  • 病例报告
    Huang Jiantong
    . 2010, 12(3): 182-2.
    A 74yearold woman with tuberculosis pleuritis received streptomycin, isoniazid, rifampin, and pyrazinamide. After one week of therapy, her liver and renal damage occurred. Antituberculous drugs were stopped and her liver and renal functions normalized. Antituberculous treatment was given again and the patient developed fever and skin pruritis. Her symptoms improved after discontinuing these drugs and receiving antiallergic treatment. Then she was administered isoniazid 0.2 g, pyrazinamide 1.0 g, ethambutol 0.75 g. Thirty minutes later, she experienced cold intolerance, fever, nausea, vomiting, confusion, and lip cyanosis. Her termperature was 40.5℃ and pulse was 120 beats/min. Subsequently, the patient presented with oliguresis, cervical rigidity. Her muscle strength was grade 2 in left upper and lower limbs while grade 0 in right upper and lower limbs. Laboratory tests revealed the following levels and values: ALT 41 U/L, AST 99 U/L, BUN 13.57 mmol/L, SCr 481 μmol/L, myoglobin 2 470 μg/L, troponin 0.52 μg/L, LDH 442 U/L, α-hydroxybutyric dehydrogenase 315 U/L, CK 2 789 U/L, CK-MB 50 U/L, and serum amylase 384 U/L. She was treated with symptomatic and supportive therapies and, two days later, her conditions relieved. Antituberculous treatment with pyrazinamide, ethambutol, levofloxacin was given again and there was no recurrence of any adverse reactions after further two months of treatments
  • 专题讲座
    . 1999, 1(3): 198-203.
  • 病例报告
    . 2007, 9(1): 55-55.
  • 药物评介
    . 2002, 4(6): 419-420.
  • 病例报告
    . 2002, 4(6): 410-410.
  • 病例报告
    . 2002, 4(4): 251-251.
  • 病例报告
    . 2001, 3(4): 229-229.
  • 病例报道
    . 1999, 1(1): 56-56.
  • 监测交流
    . 2005, 7(2): 142-143.
  • 病例报告
    . 2000, 2(4): 276-276.
  • 病例报告
    . 2006, 8(1): 55-55.
  • 病例报告
    . 2003, 5(4): 228-228.
  • 病例报告
    . 2003, 5(1): 48-48.
  • 病例报告
    . 2003, 5(4): 261-261.
  • 病例报告
    . 2004, 6(2): 113-114.
  • 系列问答
    . 2008, 10(3): 224-2.
  • 病例报告
    Tong Wei
    . 2009, 11(2): 140-2.
    A 53yearold woman with renal function insufficiency undergoing peritoneal dialysis was hospitalized with tunnel inflammation related to peritoneal dialysis. The woman received an IV infusion of aztreonam 3 g twice daily and an intraperitonal infusion of vancomycin 0.125 g dissolved in 2 000 ml of peritoneal dialysate four times daily. The next day, she developed palpitation, chest distress, short breath, and congestive erythema with a prickling sensation on her face, neck, and chest. The peritoneal dialysate containing vancomycin was withdrawn immediately. The patient underwent peritoneal lavage with vacomycinfree dialysate and received IV dexamethasone 5 mg. Twenty minutes later, her symptoms resolved. The following day, her congestive erythema disappeared. Vancomycin was discontinued and switched to intraperitoneal teicoplanin. Aztreonam was continued with no adverse reactions. One week later, the patient completely recovered and was discharged.
  • 临床论著
    Sun Lidong;Zhang Mei;Tang Xin
    . 2009, 11(3): 153-5.
    Objective: To evaluate the efficacy and safety of compound famotidine chewable tablets in treatment of symptoms in gastric acidrelated diseases. Methods: Sixty patients with gastric acidrelated diseases from September 2005 to March 2006 were randomly divided into two groups: the compound famotidine group and the famotidine group (30 cases in each group). The compound famotidine group comprised 12 men and 18 women with average age (45.50±10.09) years. The famoditine group comprised 14 men and 16 women with average age of (49.72±9.54) years. The patients in compound famotidine group received 1 compound famotidine chewable tablet (each tablet contains famotidine 10 mg, calcium carbonate 800 mg, magnesium hydroxide 165 mg) once daily when gastric acidrelated symptoms occurred on day 1; and on day 2, 1 tablet once or twice daily when symptoms occurred or 1 tablet at bed time if no symptoms occurred; the maximum daily dosage was 2 tablets. The patients in the famotidine group received 1 famotidine 20 mg capsule when gastric acidrelated symptoms occurred on day 1, and the administration were the same as those in the compound famotidine group on day 2; the maximum daily dosage was 2 capsules. The duration of treatment was 7 days in both groups. Observations included immediate symptom relief rate and complete symptom relief time 10, 30, 60, and 120 minutes after the first administration, symptom scores before treatment and after treatment completion, symptom relief rate after treatment completion, adverse reactions, routine blood tests, blood calcium level, liver and renal function, and changes in electrocardiogram. Results: The complete symptom relief time after the first administration in the compound famotidine and famotidine groups was (64.31±39.64) min and (72.75±51.41) min, respectively; there was no significant difference (P>0.05). The immediate symptom relief rate 10 and 30 minutes after the first administration in the compound famotidine and famotidine groups was 53.57% vs 82.14% and 22.22% vs 5556%, respectively; the differences were statistically significant (all P<0.05). The immediate symptom relief rate 60 and 120 minutes after the first administration was 89.29% vs 92.86% and 81.48% vs 92.59%, respectively; there was no significant difference (all P>0.05). The immediate symptom relief rate after treatment completion in both groups were 92.86% and 96.30%; there was no significant difference (P>0.05). The symptom scores in the compound famotidine and famotidine groups were (3.70±1.18) and (4.39±1.27) before treatment, and (2.93±1.12) and (2.72±1.26) after treatment completion, respectively; the difference between before treatment and after treatment was statistically significant (all P<0.01), but there was no significant difference between the two groups (P>0.05). The incidence of adverse reactions was 3.57% (one case of dry mouth) in the compound famotidine group and 7.41% (one case of dizziness and one case of nausea) in the famotidine group, there was no significant difference between the two groups (P>0.05). No abnormal changes were found in routine blood tests, liver and renal function, and blood calcium level (all P>0.05). Conclusion: Compound famotidine chewable tablets can rapidly relieve heartburn and acid regurgitation, it is a safe and effective medical preparation in treatment of symptoms in gastric acidrelated diseases.
  • 病例报告
    Cui Huidi;Yu Guilan;Zhu Liqun
    . 2008, 10(4): 0-0.
    An 83yearold woman with increased blood uric acid was administered with oral allopurinol 100 mg/day. Two weeks later, the woman developed nausea, asthenia and jaundice. Laboratory investigations revealed the following values: ALT 945 U/L,AST 1 521 U/L,TBil 259.3 μmol/L,DBil 137.8 μmol/L. Serologic tests for viral hepatitis A, B, C and E were negative. Liver damage associated with allopurinol was suspected. Allopurinol was discontinued, and compound glycyrrhizic acid glycoside was given. Her symptoms improved gradually one month later and her liver function returned to normal limits.
  • 病例报告
    . 2004, 6(2): 114-114.
  • ADR监测
    . 2004, 6(6): 417-418.
  • 病例报告
    . 2004, 6(5): 332-333.
  • 中药不良反应
    . 2006, 8(6): 436-436.
  • WHO信息
    . 2004, 6(3): 204-204.
  • 不良事件
    . 2006, 8(1): 66-66.
  • 中毒救治
    . 2005, 7(6): 434-435.
  • 病例报告
    . 2002, 4(3): 195-196.
  • 病例报告
    . 2003, 5(6): 401-402.
  • 专题讲座
    . 2000, 2(2): 137-141.
  • 病例报告
    . 2005, 7(2): 136-137.
  • 病例报告
    . 2005, 7(2): 139-139.
  • 病例报告
    . 2005, 7(2): 134-135.
  • 病例报告
    . 2005, 7(4): 314-314.
  • 个案分析
    . 2002, 4(4): 267-268.
  • 病例报告
    . 2005, 7(1): 50-50.
  • 病例报告
    . 2003, 5(5): 338-338.
  • 病例报告
    Ning Xiaohong;Zhang Zaijun;Bai Chunmei
    . 2010, 12(2): 144-2.
    A 76yearold man received controlledrelease morphine sulphate 30 mg tablets every 12 hours and potassium diclofenac 25 mg every 8 hours for pulmonary cancer pain. On day 10, the patient developed upper abdominal pain, accompanied by fever, nausea, and vomiting. His temperature was 38.5℃. Both abdominal CT scan and B-ultrasound revealed dilation of intrahepatic and extrahepatic bile duct and enlarged gallbladder. Controlledrelease morphine sulphate tablets were withdrawn and potassium diclofenac was continued. Meanwhile he was given symptomatic and supportive treatments. His symptoms relieved and abdominal Bultrasound reexamination showed no dilation of intrahepatic and extrahepatic bile duct.
  • 病例报告
    . 2007, 9(2): 139-140.
  • WANG Xue-mei;ZHAO Hong;ZHANG Jun-xia;YANG Ya-jun;CAI Feng-xia;XIE Wen;CAI Hao-dong
    . 2013, 15(6): 353-2.
    A 42-year-old man with chronic hepatitis B was treated with combined use of lamivudine 100 mg once daily and adefovir dipivoxil 10 mg once daily. After a month the patient developed muscle aches in his extremities, asthenia and edema in his lower extremities. Laboratory tests showed that creatine kinase and myoglobin were 9368 U/L and >4317 μg/L, respectively. Electromyography indicated a myogenic lesion of right deltoid muscle. Rhabdomyolysis was suspected. Lamivudine and adefovir dipivoxil were stopped. The creatine kinase levels decreased and symptoms of muscular weakness improved. One year later, the patient had recurred edema in his lower extremities, abdominal distension and intermittent fever. Creatine kinase and myoglobin were 5546 U/L and >1200 μg/L, anti-Jo-1 antibody was positive. The patient was diagnosed with polymyositis and antisynthetase syndrome. He was given treatment with liver-protective, diuretics and neurotrophic agents. Two weeks later, he was given entecavir 0.5 mg once daily. Two months later, he was given glucocorticoid treatment. One month later, the muscle aches and asthenia improved, and his creatine kinase levels dropped to normal.
  • 病例报告
    Hong Xiaojian;Yang Wei;Dou Xuekai;Zhong Jianli
    . 2010, 12(5): 357-2.
    A 62yearold man with atrial fibrillation was given amiodarone 200 mg and, 6 hours later, he received another amiodarone 200 mg. Three hours after the second administration of amiodarone, the patient developed intermittent weakness in his extremities and each episode lasted for several minutes. In the next morning, his weakness disappeared and he was treated with amiodarone 200 mg again. Half an hour later, he presented with tremor of both hands with convulsion. Laboratory test revealed a Ca2+ level of 2.38 mmol/L. Five minutes after administration of diazepem and calcium gluconate, his symptoms subsided. Subsequently, amiodarone was discontinued and the abovementioned symptoms did not recur.
  • 病例报告
    Zhao Xin;Xie Weiping;Dai Guanqun
    . 2011, 13(2): 124-2.
    A 77yearold male patient received an IV infusion of imipenem/cilastatin sodium 0.5 g in 0.9% sodium chloride 100 ml thrice daily, followed by an IV infusion of linezolid 0.6 g twice daily, then an IV infusion of ambroxol 0.045 g in 0.9% sodium chloride 50 ml twice daily for chronic obstructive pulmonary diseases accompanied by pulmonary infections. An IV infusion of voriconazole 0.2 g twice daily was added to his regimen due to Aspergillus infection. After the third intravenous administration of voriconazole, the patient developed yellow vision. Subsequently, his treatment was switched to oral administration of voriconazole 0.2 g twice daily and other drugs were continued. On day 2 of oral administration, his yellow vision was significantly relieved and, on day 6, his symptoms subsided completely. His yellow vision did not recur after further 9 days of oral voriconazole therapy.
  • Fu Yilan, Yang Liping, Gong Qian, Liu Ni, Zhu Qing, Cao Lizhi
    . 2015, 17(3): 229.
    A 50-year-old male with non-Hodgkin lymphoma received topotecan combined with cisplatin (IV infusion of topotecan 2 mg, from the first day to the fourth day; IV infusion of cisplatin from the first day to the third day, a course of treatment was 3 weeks). Blood routine examination before chemotherapy revealed the following levels: white blood cell(WBC) 4.21×109/L, neutrophil counts(NEU) 2.85×109/L. On day 2 after the end of administration of topotecan, the patient developed nausea, obvious weak. Blood routine examination showed WBC 1.88×109/L, NEU 0.99×109/L. On day 3, his body temperature increased to 38.7 ℃, blood routine examination showed WBC 0.38×109/L,NEU 0.10×109/L. The patient was diagnosed as agranulocytosis (Ⅳ degree) accompanied infective fever. He received recombinant human granulocyte colony-stimulating, sulbactam and cefoperazone, fluconazole,moxifloxacin,piperacillin and tazobactam, and isepamicin, successively. Twelve days later, his body temperature returned to normal. Twenty-three days later, blood routine examination showed WBC 5.86×109/L,NEU 4.57×109/L.
  • Yao Shuyang, Zhang Yi, Hu Mu, Wang Ruotian, Zhi Xiuyi
    . 2016, 18(2): 111.
    ObjectiveTo compare the efficacy and safety between crizotinib and platinum-containing two-drug regimens in advanced non-small-cell lung cancer (NSCLC) patients with positive echinoderm microtubule-associated protein-like 4 (EML4)-anaplastic lymphoma kinase (ALK) fusion gene.MethodsThe  hospitalization records and outpatient follow-up data of all advanced NSCLC patients with positive EML4-ALK fusion gene in Department of Thoracic Surgery, Xuanwu Hospital of Capital Medical University from December 2013 to February 2015 were collected for retrospective analysis. The patients were divided into the crizotinib group (crizotinib 250 mg twice daily, 28 days as a cycle, continuing to take crizotinib as long as progression of disease or could not tolerate due to adverse reactions) and the platinum-containing two-drug regimens group (docetaxel plus carboplatin or pemetrexed plus carboplatin, 21days as a cycle, no more than 6 cycles, continuing to take platinum two-drug regimen as long as progression of disease or could not tolerate due to adverse reactions). The efficacy [complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), overall response rate (ORR) ,disease control rate (DCR) and progression free survival (PFS)] and adverse reactions between the two groups were compared.ResultsA total of 31 patients were enrolled in the study. The crizotinib group comprised 11 and the platinum two-drug regimen group 20 patients, respectively. The difference of the general clinical data was not significant between the 2 groups. After the treatment for 2-18 cycles (median treatment cycle:8 ), among 11 patients in the crizotinib group, the best responses as PR, SD, and PD were 8 (72.7%), 2 (18.2%) and 1 (9.1%), respectively. The ORR and DCR were 72.7% and 90.9%. After the treatment of 2-6 cycles (median treatment cycle:6 ), among 20 patients in the platinum two-drug regimen group, the best responses as PR, SD, and PD were 7 (35.0%), 7 (35.0%), and 6 (30.0%), respectively. The ORR and DCR were 35.0% and 70.0%. The efficacy in the crizotinib group was better than that in the platinum two-drug regimen group (u=-2.19, P=0.04). One patient with PD in the crizotinib group was evaluated as PD after 2 cycles of treatment, its FBS was 2 months, the drugs were not stopped and the patients′conditions were not deteriorated at 10 months of follow-up. Another patient, whose efficacy was PR, changed to PD after 12 months of treatment and died due to progression of NSCLC after one month of crizotinib withdrawal. His(Her)PFS was 2 months. The patient′s condition had no further progression during the following 10-month follow-up. There were 6 patients judged as PD after 2 cycles chemotherapy in the platinum two-drug regimen group. Their PFS were 1.5 months, and they were changed the therapeutic regimen after judging as PD. Other 4 patient  in the platinum two-drug regimen group judged as PD during follow-up, and their PFS were 10.0, 4.5, 5.0, and 6.0 months, respectively. The incidence of Ⅰ-Ⅱ adverse reactions in the crizotinib group was 81.8% (9/11), and there was no Ⅲ-Ⅳ adverse reactions in the crizotinib group. The incidence of Ⅰ-Ⅱ adverse reactions in the platinum two-drug regimen group was 55.0% (11/20), and Ⅲ-Ⅳ was 45.0% (9/20). The difference in total incidence of adverse reactions between the 2 groups was statistically significant (χ2=5.872, P=0.027).ConclusionThe efficacy and safety of crizotinib are better than those of platinum-containing two-drug regimens in the treatment of  advanced NSCLC patients with positive EML4-ALK  fusion gene.
  • 病例报告
    Jia Liu;Gao Yang;Wang Hongliang;Yu Kaijiang
    . 2011, 13(2): 116-2.
    A 41yearold female patient with chronic hepatitis B cirrhosis was hospitalized and received IV infusions of reduced glutathione 1.2 g once daily and IM recombinant human interferon α-2b(rhIFNα-2b)500 ×106 U once daily. One week later, laboratory tests showed the following results: white blood cell count 1.9×109/L, neutrophil count 0.48×109/ L, hemoglobin 118 g /L, erythrocyte count 3.7×1012/L, and platelet count 81×109/L. The rhIFNα-2b was stopped, other medicines were continued, and SC recombinant human granulocytemacrophage colonystimulating factor 75μg was given once daily. On day 5 of the treatment, repeated laboratory tests showed a white blood cell count of 4.8×109/L, a neutrophil count of 3.12×109/L, a hemoglobin level of 118 g /L, a erythrocyte count of 3.8×1012/L, and a platelet count of 61×109/L. RhIFNα2b once every other day was given again. Ten days after readministration, she had a persistent fever accompanied by chest tightness and vomiting. Laboratory tests showed the following values and levels: white blood cell count 0.1×109/L, undetectable neutrophil count, platelet count 20×109/L, hemoglobin 92 g/L, erythrocyte count 3.3×1012/L. RhIFNα-2b was discontinued immediately and she received symptomatic therapy. Aplastic anemia was diagnosed according to clinical symptoms and bone marrow aspiration findings. She received additional treatment with human immunoglobulin and glucocorticoid. On day 15, her platelet count decreased to 3×109/L and Klebsiella pneumoniae was detected in her blood culture. On day 17, the patient suddenly developed dyspnea, edema, petechiae and ecchymoses. On day 19, her condition worsened and, despite resuscitation attempts, she died.
  • 病例报告
    Liu Zhenbaoa;Zhang Yanlib;Zhao Yingchuna;Sun Xiaominc
    . 2011, 13(4): 261-2.

    A 34-year-old woman received combined treatment with sulpiride 0.4 g twice daily and trihexyphenidyl 4 mg twice daily for 4 years for schizophrenia. One year ago, the patient repeatedly developed defecation and urination disorders. Her symptoms worsened more than 10 days ago. Physical examination showed mild distension of the lower abdomen and hypoactive bowel sounds. Routine blood tests showed a white blood cell count of 26.7×109/L with neutrophils 0.92. Abdominal ultrasound and CT examinations revealed paralytic ileus and urinary retention. It was considered to be associated with the concomitant long-term use of sulpiride and trihexyphenidyl. Both drugs were stopped and symptomatic and supportive treatments were given. Her symptoms improved and she was discharged.

  • 论著
    Yao Shujuan;Zhang Ping;Qi Junyuan
    . 2011, 13(5): 283-4.

    Objective: To observe the efficacy and safety of bortezomib combined with thalidomide for the treatment of relapsed and refractory multiple myeloma (MM). Methods: The clinical data from patients with relapsed and refractory multiple myeloma in our hospital between March 2007 and December 2010 were collected and analyzed retrospectively. The treatment regimen was as follows: IV bortezomib 1.3 mg/m2 was given on days 1,4,8,and 11; oral thalidomide 100 mg/d was given every day; each treatment course was 21 days. The efficacy was evaluated according to response criteria from the European Group for Blood and Marrow Transplantation (EMBT) and the adverse drug reactions were evaluated by NCI-CTCAE Version 3.0. Results: A total of 66 patients with relapsed and refractory MM received bortezomib combined with thalidomide and 7 patients were excluded because of their own reasons. At last, 59 patients were entered in this study. Of them, 37 were men and 22 were women with median age of 51 years (from 30 to 64). The median number of treatment courses was 6 (range:2-8). The median observation period was 5 months (from 2 to 10 months). Of the 59 patients, 6 were complete response, 12 were partial response, 20 were minimal response;the total effective rate was 64.4%. The most common adverse reactions were gastrointestinal symptoms (n=42, 36 cases of nausea or vomiting, 29 of diarrhea). Other adverse reactions were fatigue (37), thrombocytopenia (23), acroanesthesia (18), fever (15), breathlessness and/or palpitation (5), postural hypotension (4), vision disorders (1). The patients’adverse reaction symptoms were alleviated after dosage reduction or discontinuation of the drugs and symptomatic treatment. Conclusion: Bortezomib combined with thalidomide is an effective and safe regimen for treating patients with relapsed and refractory MM.

  • 病例报告
    Xu Yu
    . 2011, 13(5): 306-2.

    A 80-year-old man with cerebral infarction and hyperglycemia received atorvastatin calcium 20 mg once daily.

    The patient developed chest pain,chest distress, and asthenia 20 days after drug administration. Laboratory tests showed that

    creatine kinase (CK) elevated from 130 U/L to 741U/L, accompanied by abnormal renal function and electrolyte imbalances. On

    day 28, the patient received moxifloxacin 0.4g IV infusion for pulmonary infection. Subsequently, the patient’s CK elevated

    from 741U/L to 3565U/L. Atorvastatin calcium was withdrawn, and cefoperazonesulbactam sodium was given instead of

    moxifloxacin. Ten days later, his CK level gradually decreased to 54 U/L, and the other biochemical test results returned to

    normal.

  • 病例报告
    GAO Yi-fan;YANG Cheng;LI Hong
    . 2013, 15(1): 52-2.
    A 68-year-old man underwent operation for cervical spondylopathy, herniated disk, spinal canal stenosis, compressive myelopathy, and cervical spinal cord injury. After the start of the operation, dexamethasone 10 mg, cisatracurium besilate 2 mg, and hemocoagulase 2 U were given intravenously. Five minutes later, the patient′s blood pressure fell to 50/40 mm Hg, his heart rate was 130 beats/min and oxygen saturation was 0.90. He developed red rashes on his limbs and trunk. Phenylephrine, methylprednisolone, and diphenhydramine were given immediately. Meanwhile the operation was given up and surgical incision was sutured. Ten minutes later, his blood pressure rose to 110/65 mm Hg and vital signs became more stable. Three days later, he underwent operation again and, five hours after the start of the operation, he received IV cisatracurium besilate 5 mg. Five minutes later, the patient′s blood pressure fell again (55/40 mm Hg) and red rashes appeared on his limbs and trunk. Phenylephrine, methylprednisolone, and other resuscitative measures were administered. Twenty minutes later, his blood pressure returned to 105-115/65-70 mm Hg and, one hour later, his surgery was completed uneventfully.
  • 病例报告
    TONG Xue-fei;GUO Hai-jun
    . 2013, 15(2): 107-2.
    A 43-year-old male patient received rectal administration of indomethacin suppository 50 mg for fever. About 20 minutes later, the patient developed chest tightness, shortness of breath, dyspnea, cyanosis of face, lips and limbs, orthopnea, and wheeze covering both lungs. Oxygen inhalation, aerosol inhalation of budesonide, intravenous infusion of methylprednisolone and doxofylline were given urgently. Blood gas analysis showed respiratory acidosis and electrocardiogram revealed acute myocardial ischemia. He underwent endotracheal intubation and ventilator support. After 4 days of comprehensive resuscitation, his condition became gradually stable.
  • JIANG Hao;CHEN Ying;HE Ju-ying
    . 2013, 15(3): 164-2.

    A 56-year-old man received a radiotherapy plus cetuximab molecular targeted therapy for nasopharyngeal carcinoma. He received an IV infusion of cetuximab 600 mg first time, and then 400 mg once a week. Eleven days after the first medication, red macules and pustules appeared on his face, chest and back. His oral mucosa was red and swollen at the same time. Loratadine and furancilin solution were given for anti-allergic treatment and gargle. The dose of cetuximab decreased to 300 mg on the 4th medication, but the symptoms were not improved. He developed ulcers in mouth, map-like changes in corpora linguae, and skin erosion in neck. A gargle with sodium hydrocarbonate solution and anti-infective therapy were given. Cetuximab was withdrawn after 6 times of medication. About 6 weeks after drug withdrawl, the patient′s injuries in his skin and oral mucosal were improved.

  • 中药不良反应
    . 2007, 9(2): 143-144.
  • 病例报告
    . 2007, 9(1): 52-53.
  • 病例报告
    . 1999, 1(3): 179-179.
  • 病例报告
    . 2004, 6(1): 46-47.
  • 病例报告
    . 2003, 5(5): 331-332.
  • 病例报告
    . 2002, 4(6): 409-409.
  • 病例报告
    . 2001, 3(4): 255-255.
  • 不良事件
    . 2005, 7(5): 381-381.
  • 病例报告
    . 2005, 7(5): 374-375.
  • 病例报告
    . 2005, 7(5): 339-339.
  • 国外信息
    . 2005, 7(6): 466-468.
  • 药物滥用
    . 2006, 8(1): 41-41.
  • 不良事件
    . 2003, 5(1): 57-57.
  • 病例报告
    . 2001, 3(3): 197-197.
  • 个案分析
    . 2001, 3(3): 204-205.
    患者女,36岁,北京郊区农民。因头痛3d,晕厥12h,伴低热于2000年10月24日入院。患者于3d前自觉头痛、恶心,测体温正常。在当地医院就诊后回家静脉输液治疗。入院前12h,家人发现患者面色苍白,四肢厥冷,大汗淋漓,晕厥在床旁,急送医院诊治。在当地医院发现血压为0,立即给予静脉输注多巴胺和阿拉明治疗,3h后血压升至90/60mmHg,测体温37.8℃,患者神志清楚,但精神极差,自觉乏力,心慌。在当地医院观察至血压平稳后,转入上级医院求治。入院时查体:T:37.5℃,P:100次·min-1,R:18次·min-1,BP:80/50mmHg。神志清楚,四肢循环差,全身散在少量出血点和小片状瘀斑,表浅淋巴结未触及肿大。颈软,无抵抗,心肺听诊未见异常,腹平软,无压痛、反跳痛,肝脾未触及。下肢不肿,神经系统检查无异常。化验:WBC 6.0×109·L-1,N 0.75,Hb 125g·L-1,BPC 90×109·L-1,尿蛋白(+),ALT和AST均正常,Cr 183μmol·L-1,BUN:11.3mmol·L-1。入院后患者尿量较少,半日来仅400ml,怀疑为流行性出血热,但检测出血...更多热抗体IgM为(一),请求主任会诊。
  • WHO信息
    . 2001, 3(3): 206-206.
  • 病例报告
    . 2004, 6(2): 117-118.
  • 病例报告
    . 2003, 5(2): 117-117.
  • 病例报告
    . 2006, 8(5): 377-378.
  • 病例报告
    Wang Changjun
    . 2009, 11(2): 105-2.
    A 42yearold woman with acute gastroenteritis received oral metoclopramide 10 mg thrice daily and amoxicillin 1.0 g thrice daily. After 30 minutes of the first administration, the woman developed involuntary movement of extremities, difficult walking, leftward head and neck rotation, submaxilla deviation, tongue protrusion, and unclear speech. Physical examination showed a temperature of 36.5℃,a pulse rate of 96 beats/min, a respiratory rate of 24 breaths/min, and a BP of 100/70 mm Hg. She had consciousness, slowed responses, masklike face, torsion of head and neck to the left, bilateral tendon hyperreflexia, and negative pathologic reflex. Metoclopramideinduced extrapyramidal disorders were suspected. IM atropine 1 mg and IM diazepam 5 mg were given immediately. The abovementioned symptoms disappeared gradually thirty minutes later. Metoclopramide was stopped and amoxicillin was continued. The abovementioned symptoms did not reappear.
  • 安全信息
    . 2009, 11(2): 147-1.
  • 系列问答
    . 2009, 11(1): 73-2.
  • 病例报告
    Deng Xiaowei;Xu Mingbao;Shan Haili;Wang Nina;Yang Yanwen
    . 2008, 10(4): 0-0.

    A 55yearold woman with lung adenocarcinoma started receiving erlotinib 150 mg once daily after stopping paclitaxel, carboplatin, and gefitinib. Two weeks later, the woman developed skin eruption on her forehead and back. She also had paronychia on both hands and feet. A subungual abscess occurred on her great toes. The patient underwent partial excision of nail root, the dosage of erlotinib was reduced to 120 mg once daily, and epidermal growth factor gel was given for external use. Approximaly 3 weeks later, her paronychia resolved, but skin eruption on her forehead and trunk still remained.

  • 病例报告
    . 2004, 6(5): 308-308.
  • 病例报告
    . 2002, 4(1): 42-42.
  • 病例报告
    . 2001, 3(1): 50-50.
  • 病例报告
    . 2002, 4(1): 34-34.
  • 病例报道
    . 1999, 1(2): 119-119.
  • 病例报告
    . 2001, 3(4): 234-234.
  • 病例报道
    . 1999, 1(1): 48-48.
  • 病例报告
    . 2003, 5(5): 334-335.
  • 病例报告
    . 2004, 6(3): 187-188.
  • 病例报告
    . 2007, 9(2): 99-99.
  • 病例报告
    YANG Fei;QI Xiao-lian
    . 2013, 15(2): 108-2.
    A 73-year-old man was hospitalized for acute cerebral infarction accompanied by epilepsy, hypertension, bronchitis, coronary atherosclerotic heart disease, and atrial fibrillation. He received mannitol, glycerol and fructose, valsartan, bisoprolol fumarate, cinepazide maleate, ozagrel sodium, piperacillin sodium and tazobactam sodium, ceftazidime, etimicin, and atorvastatin calcium. Laboratory tests before treatment showed the following levels: alanine aminotransferase (ALT) 18 U/L, aspartate aminotransferase (AST) 25 U/L. On day 13, his ALT and AST levels increased to 243 U/L and 111 U/L. Cinepazide maleate was stopped. Glucurolactone and glutathione were given. On day 7 of cinepazide maleate withdrawal, his ALT and AST levels decreased to 36 U/L and 27 U/L, respectively.
  • 病例报告
    YANG Rui;HUANG Xin;HAN Yi;SU Le-qun;LI Hong-jian
    . 2013, 15(2): 105-2.
    A 64-year-old man received an IV infusion of moxifloxacin 0.4 g once daily with concomitant use of oral Feilike capsules (肺力咳胶囊)and oral cetirizine for pulmonary infection. On day 2, biochemical tests showed an alanine aminotransferase (ALT) level of 49 U/L and an aspartate aminotransferase (AST) level of 30 U/L. On day 5, the values of ALT and AST rose to 166 U/L and 53 U/L, respectively. On day 9, moxifloxacin was withdrawn and changed to levofloxacin 0.5 g once daily orally. Meanwhile, liver-protective treatment was given and Feilike capsules and cetirizine were continued at original dosage. On day 10, the values of ALT and AST were respectively 111 U/L and 28 U/L, and on day 13, the value of ALT was 77 U/L and the value of AST was 23 U/L. Two months later, hepatic function returned to normal (an ALT level of 28 U/L and an AST level of 21 U/L).
  • QIN Jing;QIAN Xin-yu;LI Ai-min;LUO Rong-cheng
    . 2013, 15(6): 336-6.
    ObjectiveTo explore the target and mechanisms of the cardiotoxicity of recombinant human endostatin (endostar).MethodsThe myocardial cell line H9c2 was used as subjects and the following tests were performed. (1) H9c2 cells were divided into the control group (without drug intervention), intervened groups including 100, 200, and 400 μg/ml endostar co-cultured for 24 h or 48 h, respectively. The apoptosis rate of H9c2 cells in different groups were detected by flow cytometry. (2) The H9c2 cells were divided into the control group and the intervened group of 400 μg/ml endostar co-cultured for 24 h. The changes of ultrastructure of cells were observed by transmission electron microscope. (3) The H9c2 cells were divided into the control group and the intervened groups including 100, 200, and 400 μg/ml endostar co-cultured for 18 h, respectively. The mitochondrial membrane potential was recorded by JC-1 fluorescence probe. (4) The H9c2 cells were divided into the control group and the intervened group of 400 μg/ml endostar co-cultured for 24 h. The release condition of cytochrome C were observed by method of immunocytochemistry. (5) The H9c2 cells were divided into the control group and the intervened groups including 100, 200, and 400 μg/ml endostar co-cultured for 24 h, respectively. The ADP/ATP ratio was detected by the method of chemiluminescence.Results(1) The apoptotic rate of 200 μg/ml endostar co-cultured for 24 h group and the 400 μg/ml endostar co-cultured for 24 h and 48 h groups were higher than that in the control group [24 h:(16.34±3.72)%, (27.03±3.91)% vs.(6.99±1.72)%; 48 h:(24.89±477)% vs.(6.44±1.81)%; all P<0.01]. The apoptotic rate of the 200 μg/ml endostar co-cultured for 24 h group was higher than that in the endostar co-cultured for 48 h group[(16.34+3.72)% vs.(11.34±309)%, P<0.01]. (2) The H9c2 cells′ ultrastructure of control group presented normal. The H9c2 cells in the group of 400 μg/ml endostar co-cultured for 24 h showed pyknotic and fragmental in nuclei, the massed chromatin, intracellular vacuoles, dilation of endoplasmic reticulum, mitochondrial swelling, and appearance of apoptotic body. (3) Compared with the control group, the degree of depolarization of mitochondrial transmembrane potential decreased following of the increasing concentration of endostar in 100, 200, and 400 μg/ml endostar intervened groups. (4) Cytochrome C of the H9c2 cells in the control group mainly distributed in the mitochondria. Cytochrome C of the H9c2 cells in the group of 400 μg/ml endostar co-cultured for 24 h were released from mitochondria to the cytoplasm. (5) ADP/ATP ratio of H9c2 cells in the 200 μg and 400 μg/ml endostar groups were significantly higher than those in the control group(1.14±0.11, 1.31±0.18 vs. 0.98±0.09, all P<0.01). ConclusionsCardiomyocyte mitochondria may be the target of the cardiotoxicity of endostar. The cardiomyocyte apoptosis evoked via the mitochondrial-dependent pathway is one of the mechanism of myocardial damage.
  • LI Feng-yun; HUANG Ya-qiu; MA Chao; ZHANG Shu-rong
    A 79-year-old female patient received an IV infusion of moxifloxacin 400 mg once daily for hospital acquired pneumonia. On the night, the patient experienced talking to herself, anxiety, and a blood pressure of 135/85 mm Hg. The anti-infective treatment continued following the doctor′s advice. Hereafter she developed worsened psychic symptoms which included being not able to know families, irrelevant reply, hallucination, mania, and agitation. After infusion of moxifloxacin for 5 days, she presen-ted with a blood pressure of 190/110 mm Hg, a temperature of 39.6 ℃, and a normal electroencepha-logram. Moxifloxacin was stopped and changed to an IV infusion of meropenem 0.5 g once every 8 hours. Meanwhile, irbesartan was added to the regimen for control of blood pressure. Two days later, her psychic symptoms relieved and the blood pressure and temperature returned to within normal range. At a follow-up 2 weeks later, her blood pressure remained normal basically when irbesartan was not taken again after discharge and psychic symptoms did not recur.
  • 安全用药
    ZHAO Li-ping;REN Hua-li;ZHOU Ying;CUI Yi-min
    . 2012, 14(2): 98-3.
    Levetiracetam (LEV)-induced hematological adverse reactions include leukopenia, neutropenia, thrombocytopenia, and pancytopenia; and the incidence was 0.01%-0.13%. The shortest time to LEV-associated thrombocytopenia onset or aggravation is 3 days after drug administration and the longest time could reach to 60 days after drug use. Meanwhile, hypochromia or pancytopenia may occur. The platelet count could decrease to < 1×109/L in the serious patient. Besides the reduction of platelet count showed by laboratory test, mucosal bleeding, skin petechia, hematuria, and other symptoms may also develop. Although the mechanism of LEV-associated thrombocytopenia is unclear, marrow suppression, immune complex formation, and direct harm by nonimmune factors are thought to be related to it. Attention should be paid to the patients with symptoms and signs related to thrombocytopenia after LEV use and routine blood tests should be regularly performed. LEV should be withdrawn immediately if thrombocytopenia-related symptoms occur. Patient with more mild symptoms can recover spontaneously one week after drug discontinuation and patient with more severe symptoms should be treated with platelet transfusion. Patients with severe hemorrhagic symptoms could be treated with short-term glucocorticoid.
  • 病例报告
    Hao Zhiqiang
    . 2010, 12(3): 222-1.
    A 45yearold man suffering from prostatitis took 4 Pulean tablets thrice daily. He developed hematuria after one week of treatment. Pulean tablets were discontiuned and routine urine test showed that hematuria disappeared. Two months later, the patient took pulean tablets again according to his previous dosage and then hematuria recurred . The drug was stopped, and his hematuria did not recur at oneyear follow up.
  • 中毒救治
    Shen Wei;Qiu Zewu;Peng Xiaobo
    . 2010, 12(6): 419-2.
    Two patients,a 36yearold man and a 68yearold woman,were hospitalized with numbness and stabbing pain in their extremities. The blood thallium concentrations in the patients 1 and 2 were 1 642 and 158 μg/L, respectively. Thallium poisoning was diagnosed. The patients were treated with oral prussian blue 250 mg/(kg·d), blood purification, etc. Subsequently, the blood thallium concentrations in the patients 1 and 2 gradually decreased to 5 and 4 μg/L, respectively; their clinical symptoms were significantly relieved.
  • Su Yanyan, Zhang Yunfang, Li Hongyan, Luo Jie
    . 2015, 17(6): 473-474.
    Two female patients receiving peritoneal dialysis aged 52 (case 1) and 57 (case 2) were treated with fenofibrate 200 mg once daily for increasing serum triacylglycerol. They experienced muscular soreness and weakness in lower limbs and back on 6 and 8 days after taking fenofibrate, respectively. The case 2 also had reduced urine volume. Laboratory tests showed the following values in case 1: serum aspartate aminotransferase (AST) 154 U/L, creatine kinase (CK) 1 862 U/L, creatine kinase isoenzyme (CK-MB) 67 U/L, lactate dehydrogenase  (LDH)1 074 U/L, urea nitrogen 14.5 mmol/L,creatinine 926 μmol/L, glomerular filtration rate (GRF) 5.4  ml·min-1·1.73 m-2, and myoglobin >1 000 μg/L. Laboratory tests showed the following values in case 2: AST 150 U/L, CK 10 070 U/L, CK-MB 171 U/L, LDH 399 U/L,urea nitrogen 12.9 mmol/L, creatinine 881 μmol/L, GFR 4.3  ml·min-1·1.73 m-2, and myoglobin >1 000 μg/L.The patients were diagnosed as rhabdomyolysis due to fenofibrate. The symptoms of muscle aches and fatigue in the  2 patients disappeared on day 5 and 3 after fenofibrate withdrawal, respectively. Laboratory tests showed the following values 12 days after drug withdrawal in case 1: AST 35 U/L,CK 68 U/L,CK-MB 23 U/L,LDH 626 U/L, usea nitrogen 10.6 mmol/L, creatinine 725 μmol/L. Laboratory tests showed the following values 7 days after  drug withdrawal in case 2: AST 37 U/L, CK 219 U/L, CK-MB 18 U/L, LDH 356 U/L, urea nitrogen 12.5 mmol/L and  creatinine 852 μmol/L. Her urine volume returned to the level recorded before medication.
  • Huang Ying, Wang Chunmei, Li Jianxin, Wei Libing, Ning Yachan
    . 2015, 17(2): 152-154.
    A 73-year-old male patient underwent stent implanting of left iliac artery and recanalization of left superficial femoral artery due to atherosclerotic obliterans of artery of lower extremity and received IV push of 4 000 U unfractionated heparin (UFH) during the operation. On the operation day, the patient was transferred into Intensive Care Unit due to acute renal insufficiency caused by left perirenal hematoma and acute cardiac insufficiency. Laboratory examination showed the following values: hemoglobin 147 g/L, platelet count 113×109/L, serum creatinine 247 μmol/L, blood urea nitrogen 10.6 mmol/L. On day 2 postoperation, he received non-heparin continuous renal replacement therapy on bed (the tubes were rinsed with UFH before hemodiafiltration and deep venous catheters were sealed with UFH during the hemodiafiltration). On day 3 postoperation, the patient′s PLT dropped to 73×109/L. On day 5 postoperation, the temperature of his left foot decreased and the pulse of dorsal artery of his left foot disappeared. UFH was given intravenously at the rate of 500-625 U per hour. On day 7 postoperation, the patient′s PLT suddenly dropped to 16×109/L, he developed skin cyanosis on his left lower limb and cyanoderma on his plantar. Vascular ultrasonography examination showed that thrombosis occurred on his left femoral vein and right internal jugular vein, occlusion appeared on his left superficial femoral artery. Heparin-induced thrombocytopenia with thrombosis was considered. UFH was stopped immediately and intravenous argatroban was given and tube rinsing and sealing with UFH was replaced with saline in continuous renal replacement therapy. On day 12 postoperation, the PLT count increased to 121×109/L. However, the patient died of multiple organ failure at last.
  • Zhang Xi;Ma Xiaoya
    . 2015, 17(1): 74-2.
    A 7-year-old boy with epilepsy received sodium valproate (0.25 g in the morning and 0.5 g at night) for 2 years. Lamotrigine was added because of exacerbation of the illness. The dosage of lamotrigine on the first, second and third weeks were 12.5, 25.0, and 37.5 mg once daily, respectively. On day 15 of taking lamotrigine, he developed erythema on foot, accompanied by pruritus and reddening of the eyes. After that the boy developed erythema on entire body, blister on neck, arms and legs, erosion of oral mucosa occurred accompanied by fever. The boy was hospitalized on day 20 of taking lamotrigine. Laboratory tests showed the following values: white blood cell count 7.6×109/L, red blood cell count 3.9×1012/L, hemoglobin 106 g/L, high-sensitivity C-reactive protein (hs-CRP) 5.5 mg/L, albumin 25 g/L, alanine aminotras nferase (ALT) 66 U/L, and aspartate aminotransferase (AST) 58 U/L. Lamotrigine was withdrawn, and the boy received the symptomatic treatments including anti-inflammation, anti-anaphylaxis, liver protection and fluid infusion. On day 3 of admission, the boy developed high fever, drowsiness and shiver. Laboratory tests showed the following values: ALT 47 U/L, AST 33 U/L, lactate dehydrogenase (LDH) 207 U/L, creatine kinase 322 U/L, creatine kinase isoenzyme (CK-MB) 185 U/L, and alpha-hydroxybutyric dehydrogenase 258 U/L. Meanwhile vesicles appeared on erythematous skin and ulcers occurred. A large area of exfoliation appeared on his neck and face. Ulcers were red with exudates. The purulent secretion was secreted from dental ulcer surface. He was diagnosed as toxic epidermal necrolysis. Then the boy received complex treatments included methylprednisolone, compound glycyrrhizin,gamma globulin, and antimicrobial drug. On day 9 of admission, most liquid in the blister on the trunk and limbs were absorbed. Laboratory test showed the following values: LDH 205 U/L, creatine kinase 247 U/L, CK-MB 31 U/L, ALT 28 U/L,and AST 23 U/L. On day 13 of admission, the boy′s vital sign were stable, erythema on the body disappeared. On day 15, he was discharged. The result of follow-up one year later showed no scars on the boy′s skin.
  • Hou Xiaoping, Wei Xuan
    . 2015, 17(5): 371.
    Two elderly patients (one was male, 90 years-old; the other female, 63 years-old) with coronary disease and depression received citalopram 20 mg daily for 4 years and 1 year, respectively. The width of their electrocardiogram QT interval was normal. They received diltiazem 15 mg three times daily (the male) and 30 mg three times daily (the female) due to recurrent attacks of angina pectoris. QT interval prolongation was found by electrocardiographic examination on day 4 (the male) and day 83 (the female) of medication with diltiazem, the QT interval/corrected QT interval(QT/QTc) were 448/526 ms (the male) and 430/447 ms (the female), respectively. The QT/QTc in the male patient decreased to 432/510 ms 5 days after diltiazem withdrawal. The QT/QTc in the female patient decreased to 388/406 ms on 35 days after diltiazem′s dosage was halved.
  • Zhang Xiaolan, Zhao Peng, Ma Guoxian, Gao Jiayi
    . 2015, 17(4): 296.

    A 68-year-old female patient with multiple fractures of the right distal radius received oral compound codeine phosphate and ibuprofen sustained release tablets (containing ibuprofen 0.2 g, codeine phosphate 13 mg per tablet) 3 tablets twice daily  after plaster external fixation. Ten minutes after the first administration, the patient developed wheezing, palpitation, pale, cough, expectoration, nausea, and vomiting. Oxygen inhalation, IV infusion of doxofylline and methylprednisolone sodium succinate for injection, and terbutaline sulphate solution for nebulization and budesonide suspension for inhalation were given immediately. Two hours after treatments, wheezing was relieved and wheezing rales in the lung disappeared. By asking the medical history, it was found that the patient had developed wheezing after taking somedon and was diagnosed as bronchial asthma 1 month ago in another hospital.

  • Yang Qing, Tong Deyin, Jin Xin, Li Shuang, Yuan Ling, Cai Ning
    . 2018, 20(1): 43.
    Allopurinol is an inhibitor of xanthine oxidase, which is used for the treatment of gout and hyperuricemia by inhibiting uric acid synthesis thereby reducing uric acid. Allopurinol can cause severe cutaneous adverse reactions (SCAR), including drug hypersensitivity syndrome, Stevens-Johnson syn-drome (SJS), and toxic epidermal necrolysis (TEN). The study on the correlation between HLA-B*58∶01 alleles and allopurinol-induced SCAR in different racial groups showed that there was a strong correlation between HLA-B*58∶01 alleles and allopurinol-induced SCAR in Taiwan, Hong Kong, and the mainland of China, as well as in Thailand, Korea with high frequency of HLA-B*58∶01, while there was also an significant correlation between them in Japan and Europe with low frequency of HLA-B*58∶01. Presently, there have been few studies on the specific mechanism of HLA-B*58∶01 alleles in the process of the allopurinol-induced SCAR. Representative research found that allopurinol and its metabolite oxypurinol directly and immediately activates the drug-specific T cells by bounding to HLA-B*58∶01 through the mechanism of pharmacological interaction with immune receptors, afterwards leading to SCAR.
  • Hu Lin, Li Taoming, Dai Tingting, Zou Le, Yin Tao
    ObjectiveTo understand the clinical features of drug-induced kidney injury (DIKI) in inpatients.MethodsThe  medical records data of inpatients diagnosed as DIKI from January 31, 2010 to January 31, 2017 were retrospectively analyzed. The main analytic indicators included general conditions of patients, degree of renal damage, outcomes, and suspected drugs causing acute kidney injury (AKI), and so on.ResultsA total of 20 patients were entered into this study, including 16 males (80.0%) at age 8 to 80 years and the average age of (44±20) years, 4 females (20.0%) at age 27 to 71 years and the average age of (49±22) years. Eleven patients (55.0%) were ≤44 years old (young people), 4 patients (20.0%) were 45-59 years old (middle-aged people), 5 patients (25.0%) were ≥60 years old (old people). The kinds of diseases were 2 to 6 in each patient in the 20 patients. Of them, 3 patients (15.0%) had 2 kinds of diseases at the same time, 7 patients (35.0%) had 3 kinds of diseases, 5 patients (25.0%) had 4 kinds of diseases, 4 patients (20.0%) had 5 kinds of diseases, 1 patient (5.0%) had 6 kinds of diseases. The serum creatinine (Scr) and blood urea nitrogen (BUN) values in the 20 patients were 56.0-132.5(89.1±22.1)μmol/L and 2.9-8.5(4.9±1.6)mmol/L before medication, respectively and significantly increased to 128.0-506.0 (241.8±112.8) μmol/L and 4.3-28.0 (13.0±5.9) mmol/L after medication, respectively. After treatments with hemodialysis or renal protective drugs, the Scr and BUN values were significantly reduced to 52.0-439.0(174.8±97.5) μmol/L and 1.0-27.6(9.3±7.1)mmol/L, respectively. The differences of Scr and BUN levels between before medication and after medication, before treatment and after treatment were statistically significant (all P<0.05). All DIKI during hospita-lization were AKI. Six patients (30.0%) were in AKI stage 1, 10 patients (50.0%) in AKI stage 2, and 4 patients (20.0%) in AKI stage 3 (acute renal failure). By the time of discharge, 5 patients were cured, in 12 patients the condition was improved, 1 patient had no change, in 1 patient the condition was deteriorated, and 1 patient died. The effective rate of treatments was 85.0%. A total of 29 kinds of drugs were used in combination in the 20 inpatients, and 6-24(14±5) kinds of drugs were used in each patient. Five categories and 12 drugs were found to induce kidney injury in this study, involving antibacterial drugs(15 patients), chemotherapeutic drugs (2 patients), antiviral drugs (2 patients), immunosupp-ressants (3 patients), and anti-gout drugs(1 patient). Kidney damage was clearly documented in the instructions of all above-mentioned drugs. The time from medication to onset of DIKI was 1-56 days and the median time was 9 days.ConclusionsAntibacterial drugs, especially antifungal drugs such as amphotericin B, were the main drugs causing kidney injury in hospital. The DIKI was AKI during hospitalization, and the treatment effect for AKI was good.
  • Yi Qiaoyan, Xie Yanjun, Shu Yutong, Zhang Qiuhong, Qi Yingmei, Li Min, Zhao Xia, Liu Fengqin, Li Xia, Han Yi
    Adverse Drug Reactions Journal. 2024, 26(3): 133-137. https://doi.org/10.3760/cma.j.cn114015-20230824-00629
    Objective To explore the adverse cardiac event risk signals in arsenical for injection, improve the clinical understanding of the cardiac toxicity of arsenical. Methods The risk signals of adverse cardiac events associated with arsenical for injection were mined using 3 methods, including reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, and the Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard method based on data in Shandong Provincial Center of Adverse Drug Reaction Monitoring (Shandong data) in China from the first quarter of 2003 to the fourth quarter of 2022 and the data in US FDA Adverse Event Reporting System (FAERS) database from the fourth quarter of 2003 to the third quarter of 2023. The definition of risk signal in ROR and PRR method was the number of adverse event reports ≥3 and the lower limit of 95% confidence interval (CI) of ROR and PRR >1. The definition of risk signals in MHRA comprehensive standard method was the number of adverse event reports ≥3, PRR>2, and χ2>4. Results There were a total of 358 reports on arsenical for injection in Shandong data, of which 275 (76.8%) were related to arsenious acid and sodium chloride injection, and 83 (23.2%) were related to arsenic trioxide for injection. Among the 358 reports, adverse cardiac reactions were reported in 25 reports (7.0%), and severe cases accounted for 28.0% (7/25). There were a total of 1-294 reports on ATO in FAERS, and adverse cardiac events were reported in 418 reports (32.3%), of which severe cases accounted for 62.2% (260/418). The signal mining results form 275 reports on arsenious acid and sodium chloride injection in Shandong data showed that QT interval prolonged, chest tightness, cardiopalmus, and palpitations were risk signals. Among them, the signal strength of QT interval prolonged was the strongest. A total of 35 adverse cardiac event signals were mined in FAERS data, of which the signal strength of QT interval prolonged and long QT syndrome were the strongest. In addition, the strength of 6 arrhythmia signals (bradyarrhythmia, supraventricular premature contraction, ventricular premature contraction, torsade de pointes, ventricular tachycardia, and atrioventricular block) and 6 cardiac organic lesion signals (pericarditis, endocarditis, pericardial effusion, myocarditis, mitral regurgitation, and cardiac enlargement) also ranked high. Conclusions Arsenical for injection is strongly associated with cardiotoxicity, and the proportion of severe cases is relatively high. The cardiotoxicity mainly affects the QT interval, and can also manifest as various types of arrhythmias and some cardiac organic lesions. 
  • Lin Na, Zhao Mengmeng, Wang Guyan
    Adverse Drug Reactions Journal. 2023, 25(6): 332-338. https://doi.org/10.3760/cma.j.cn114015-20230425-00308
    Objective To observe the occurrence of residual neuromuscular blockade (RNMB) in post anesthesia care unit (PACU) in patients undergoing selective laryngeal surgery under general anesthesia and provide reference for improving the safety of muscle relaxants during the perioperative period. Methods The adult patients who underwent laryngeal surgery in Beijing Tongren Hospital, Capital Medical University from July 2020 to March 2021 were collected. According to the muscle relaxants used in the surgery, the patients were divided into rocuronium bromide group, mivacurium chloride group, and cisatracurium group. The general information of patients in the different groups [age, body mass index, American Society of Anesthesiologists (ASA) classification, etc.], duration of surgery, anesthesia time, stay time in PACU, and recovery of neuromuscular function (expressed using train of four ratio, abbreviated as TOFr) were recorded and analyzed. The ability to speak and raise one′s head in PACU, as well as the occurrence of adverse events such as gastroesophageal reflux, aspiration, and dyspnea were also recorded. Results A total of 320 patients were enrolled in the study, including 188 males (58.8%) and 132 females (41.2%), with a mean age of (50±13) years. The duration of surgery was (38.6±30.1) minutes, anesthesia time was (57.2±32.8) minutes, and stay time in PACU was (34.6±11.4) minutes. There were 115, 141, and 64 patients in the rocuronium bromide, mivacurium chloride, and cisatracurium groups, respectively. The differences in age, body mass index, and ASA grade in patients among the 3 groups were not significant (all P>0.05). The anesthesia time and duration of surgery in patients of the mivacurium chloride group were shorter than those of the rocuronium bromide and cisatracurium groups [(43.53±23.90) minutes vs. (67.54±37.72) minutes and (68.84±29.34) minutes;(26.87±22.18) minutes vs. (47.16±34.83) minutes and (48.84±27.57) minutes], and the differences were statistically significant (all P<0.01). The difference in stay time in PACU among the 3 groups was not statistically significant (P>0.05). At the moment of entering PACU, 272 (88.6%) of 320 patients had TOFr<0.9, of which 105 (32.8%) had TOFr<0.7; when leaving PACU, the TOFr of all patients was>0.9. Except the time point of leaving PACU, TOFr in the rocuronium bromide group at the other time points were higher than those in the cisatracurium group (all P<0.01). Except the 2 time points of the moment of entering and leaving PACU, TOFr in the mivacurium chloride group was higher than those in the cisatracurium group (all P<0.01). At the moment of entering PACU and 5-minutes after entering PACU, TOFr in the mivacurium chloride group was lower than those in the rocuronium bromide group (all P<0.05). When entering PACU, 79 of 320 patients had saturation of pulse oximetry (SpO2)<0.95 and the difference in SpO2-among the 3 groups was statistically significant (P=0.029), of which 4 cases (6.25%) had SpO2<0.90 in the cisatracurium group, and the incidence of hypoxemia was higher than that in the other 2 groups. The differences in ability of speach and head lifting of patients among the 3 groups when entering PACU were statistically significant (P=0.036, P<0.001). No adverse events such as reflux, or aspiration, dyspnea occurred in patients in PACU. Conclusions The incidence of RNMB in patients undergoing laryngeal surgery entering PACU immediately is high and the degree of RNMB is more severe, with TOFr gradually increasing and RNMB decreasing over time. The patients who receive cisatracurium have a high incidence and severity of postoperative RNMB. Routine monitoring and neuromuscular monitoring in PACU are beneficial for patients′ perioperative safety.
  • Li Jia, Chen Xiao
    Adverse Drug Reactions Journal. 2024, 26(6): 326-330. https://doi.org/10.3760/cma.j.cn114015-20240321-00184
    Anti-microbial agents are one of the most widely used drugs in clinical practice, with a high incidence of adverse drug reactions, and the safety problem is very prominent. There are many factors that affect the occurrence, development and severity of adverse reactions caused by anti-bacterial agents. The research on the related risk factors is one of the measures to ensure the safety and effectiveness of anti-  infection treatment, and it is also the premise of preventing and identifying adverse reactions caused by anti-bacterial agents. This paper summarizes and evaluates the research hotspots and methods on common adverse reactions risk factors for anti-bacterial agents, and puts forward relevant suggestions according to the problems and deficiencies existing in the current research status, with the aim of promoting research on adverse reactions-related risk factors for anti-bacterial drugs in China and ensure the safety of patients′ medi-cation.
  • 安全信息
    . 2014, 16(5): 285-1.
  • Lin Fangfang, Wang Ling
    . 2016, 18(5): 373.
    A 35-year-old male patient with right parietal lobe cerebral hemorrhage broke into the ventricle and bilateral pneumothorax received IV infusions of tazobactam sodium/piperacillin sodium 4.5 g every 8 hours, teicoplanin 400 mg every 12 hours, mannitol 125 ml thrice daily, esomeprazole sodium 40 mg once daily and ambroxol 45 mg twice daily. On day 3, laboratory tests showed the following results: alanine aminotransferase (ALT) 99 U/L, aspartate aminotransferase (AST) 120 U/L, γ-glutamine transferase (γ-GT) 299 U/L, alkaline phosphatase (ALP) 87 U/L. The dosage of teicoplanin was changed to 400 mg once daily. He was given an IV infusion of reduced glutathione 2.4 g once daily. The next day, aminotransferase levels continued to elevate, esomeprazole sodium was stopped and he received an IV infusion of magnesium isoglycyrrhizinate 200 mg once daily, parenteral nutrition was changed to enteral nutrition. On day 8, his liver function reexamination showed the following levels: ALT 430 U/L, AST 262 U/L, γ-GT 456 U/L, ALP 164 U/L. Acute drug-induced liver injury induced by teicoplanin was considered. The teicoplanin was stopped. His therapy was changed into vancomycin 1 g every 12 hours and other drugs were continued. Twenty-three days after teicoplanin withdrawal, the values of ALT, AST, γ-GT and ALP were 130 U/L, 51 U/L, 49 U/L, and 94 U/L, respectively.
  • 病例报告
    Lv Dong;ZHAO Min
    . 2012, 14(6): 391-2.
    A 68-year-old male patient received an IV infusion of moxifloxacin 0.4 g once daily for infection after radical surgery for cardiac cancer under abdominoscope. On day 10, the patient developed yellow sclera and laboratory tests revealed the following values: total bilirubin 58.6 μmol/L, direct bilirubin 37.4 μmol/L, alkaline phosphatase (ALP) 130 U/L, γ-glutamyl transferase (γ-GT) 147 U/L, alanine aminotransferase (ALT) 25 U/L, aspartate aminotransferase (AST) 38 U/L. On day 13, ALT and AST levels increased to 1582 U/L and 3285 U/L, respectively. Moxifloxacin was withdrawn immediately, and his therapy was changed to imipenem cilastatin sodium. At the same time, he received an IV infusion of reduced glutathione 2.7 g once daily. Twenty-seven days after moxifloxacin withdrawal, the patient’s indicators of liver functions returned to normal level except that ALP and γ-GT levels were still higher than the normal value.
  • ZHAO Hui;ZHAO Ying;ZHEN Jian-cun;ZHAO Xing-shan
    An 87-year-old woman with convulsions and bradycardia received a continuous IV infusion of sodium valproate 1200 mg once daily by a pump at a rate of 20 ml per hour. Her platelet count was 214×109/L before treatment. Eight days after treatment, her platelet count decreased to 63×109/L. Sodium valproate injection was withdrawn and her therapy was changed to sustained-release sodium valproate tablets 500 mg/d once daily. Five days later, the patient′s platelet count decreased to 25×109/L. Sustained-release sodium valproate tablets were withdrawn. The patient received platelet transfusion 1 U and amino-polypeptide tablets 1000 mg three times a day. After eight days of symptomatic treatment, the patient′s platelet count increased to 160×109/L.
  • BAO Shi-jie;ZHOU Xiao-yong
    . 2013, 15(3): 165-2.

    Two male patients, aged 17 and 36 years old, took amoxicillin 0.5 g for upper respiratory tract infection. Erythema appeared on their trunk about four hours after taking the third dose in patient 1 and about six hours after taking the first dose in patient 2, respectively, and then spread to their whole body, accompanied by fever. Acute generalized exanthematous pustulosis was diagnosed. Anti-inflammatory and anti-allergy treatments were given. Five days later, the erythema and pustules basically subsided.

  • 病例报告
    . 2007, 9(2): 140-140.
  • 病例报告
    . 2004, 6(1): 47-47.
  • ADE简报
    . 2000, 2(1): 58-58.
  • 病例报告
    . 1999, 1(3): 181-181.
  • 不良事件
    . 2005, 7(1): 63-63.
  • 病例报告
    . 2005, 7(3): 225-225.
  • 病例报告
    . 2005, 7(3): 219-219.
  • 病例报告
    . 2000, 2(2): 121-121.
  • 病例报告
    . 2002, 4(2): 124-124.
  • 病例报告
    . 2001, 3(2): 115-116.
  • 不良事件
    . 2003, 5(1): 69-69.
  • WHO信息
    . 2003, 5(5): 352-352.
  • 病例报告
    . 2006, 8(2): 147-147.
  • WHO信息
    . 2003, 5(4): 276-276.
  • 病例报告
    . 2000, 2(4): 253-253.
  • 病例报告
    . 2001, 3(3): 200-200.
  • 病例报告
    . 2003, 5(2): 116-116.
  • 病例报告
    . 2003, 5(2): 110-111.
  • 病例报告
    . 2006, 8(3): 216-216.
  • 病例报告
    . 2001, 3(3): 198-198.
  • 病例报告
    Miao Jieping
    . 2008, 10(4): 0-0.
    A 69yearold woman with uremia undergoing longterm hemodialysis was treated with an IV infusion of cefepime 1.0 g twice daily for pulmonary infection. Three days later, the woman developed aphasia, apathy, isomnia, and abnormal behaviors. An EEG examination showed mild-to-moderate abnormality without spike and sharp wave activity. Nonconvulsive status epilepticus was excluded. Cefepime-induced psychiatric disturtance was suspected. On day 5, cefepime was stopped. Two days later, she fully recovered.
  • 病例报告
    . 2004, 6(6): 407-408.
    A 23-year-old man complained of headache, sore throat and fever for 2 days and was diagnosed as upper respiratory tract infection in a clinic. The patient developed nausea, abdominal distension, abdominal pain and diarrhea after receiving intravenous infusion of levofloxacin 200mg. Physical examination showed abdominal muscular tension, abdominal tenderness and positive shifting dullness while ultrasound suggested ascites.His symptoms were resolved after stopping the medication and taking dexamethasone 15mg. No abnormality on abdomen was found by ultrasound. Six months later, the same symptoms were recurred after intravenous infusion of levofloxacin 200mg and returned to normal gradually after withdrawal of levofloxacin and start of the same therapy. It is considered that ascites is associated with levofloxacin.
  • 病例报告
    Li Jia;Wang Chunping;Tian Shuohan
    . 2008, 10(2): 140-2.

    A 30yearold woman underwent caesarean section was presented with a fever(37.7-39.5 ℃)from the day of surgery to day 5 after surgery. Bacterial culture tests showed that she was infected with E.coli. The patient was administered with imipenem/cilastatin 500 mg dissolved in 250 ml of sodium chloride 0.9% intravenously. Fifteen minutes later, the woman developed chill, palpitation, and dyspnea. The medication was withdrawn immediately. She was given oxygen therapy, physical hypothermy, and corticosteroids. Fortyfive minutes later, her symptoms were relieved, and two hours and a half later, her temperature was 38.4 ℃.

  • 病例报告
    . 2000, 2(3): 176-176.
  • ADR监测与防治
    . 2000, 2(3): 175-175.
  • 病例报告
    . 2001, 3(2): 116-117.
  • 病例报告
    . 2001, 3(4): 277-277.
  • WHO信息
    . 2001, 3(4): 265-265.
  • 病例报告
    . 2001, 3(4): 253-253.
  • 安全用药
    . 2002, 4(2): 92-93.
    目的:分析鱼胆中毒误用皮大霉素的教训,以避免误诊误治加重肾脏损害。方法:回顾性对比分析35例鱼胆中毒的治愈率及肾功能损害情况。结果:35例鱼胆中毒未用庆大霉素22例患者全部治愈,13例误用庆大霉素的患者中2例死于急性肾功能衰竭,1例转为慢性肾功能衰竭。未用与使用庆大霉素患者的治愈率比较,经卡方法计算确切概率,P<0.05。肾功能损害程度,血液透析次数,用庆大霉素组明显高于未用庆大霉素组,P<0.01。结论:鱼胆中毒后再误用庆大霉素更加重急性肾功能衰竭的恶化。
  • 病例报告
    . 2003, 5(5): 336-336.
  • 综合报道
    . 2000, 2(1): 44-47.
    本文检索MEDLINE,EMBASE和PHARMBASE近5年文献中药物对泌尿系统的不良反应,包括出血性膀胱炎、尿潴留、尿失禁、膀胱癌和泌尿系统结石。
  • 中药不良反应
    . 2007, 9(1): 60-61.
  • HAN Yu-bo;CHENG Zhi-min;LI Xiang-hui
    . 2013, 15(3): 168-2.

    A 57-year-old woman, who had 20 years history of hypertension, was treated with long-term use of oral aspirin, nifedipine, and bisoprolol fumarate. Oral clopidogrel hydrogen sulfate 75 mg once daily and an IV infusion of cinepazide maleate 320 mg once daily were added to her regimen due to angina pectoris caused by coronary atherosclerotic heart disease. Six hours later, the patient developed intermittent hematuria, followed by urinary frequency, urinary urgency, and urodynia. Routine urine test showed occult blood (+++) and 17 red blood cells/HP. Ultrasonography showed no abnormal changes in bilateral kidney and bladder. Clopidogrel hydrogen sulfate was withdrawn. The next day, her urine color was normalized gradually and routine urinalysis showed occult blood (++) and 4 red blood cells/HP. Three days later, all results in the routine urine test was within normal range.

  • SHI Xiu-jin;WEI Guo-yi;ZHOU Yang;ZHENG Qing-min
    . 2013, 15(3): 141-7.

    ObjectiveTo understand the changes in cyclosporine A (CsA) blood concentration, the occurrence of rejection and adverse reactions in patients after heart transplantation (HT), and to explore their correlations.MethodsThe clinical data of patients who underwent HT in Beijing Anzhen Hospital from January 2010 to December 2011 were collected and analyzed retrospectively. The patients′general condition, monitoring situation of CsA blood concentration, as well as the occurrence of rejection and adverse reactions were recorded. The relationship between CsA trough concentration (C0), peak concentration (C2), and rejection, adverse reactions were analyzed.ResultsTwenty-seven patients were enrolled in the analysis. They comprised 24 males and 3 females with a mean age of (38±14) years, a mean height of (170±10) cm, a mean body weight of (68.0±15.8) kg. Primary diseases included 18 cases with dilated heart disease, 4 cases with coronary atherosclerotic cardiopathy, 3 cases with valvular cardiomyopathy, one case with arrhythmogenic right ventricular cardiomyopathy, and one case with noncompaction of ventricular myocardium. The CsA blood concentration was low in early postoperative phase(<1 month). Of the 75 C0 tests, the levels of C0 in 35 tests (46.7%) were below the range of effective concentration. Of the 69 C2 tests, the levels of C0 in 56 tests (81.2%) were below the range of effective concentration. C0 increased from 1 to 3 months after HT, decreased gradually 4 months after HT, and tended to be stable 7 months after HT. C2 increased from 1 to 3 months after HT, decreased gradually 4 months after HT, and increased slightly 13 months after HT. Rejection occurred in 9 of the 27 patients (33.3%), in 8 cases acute rejection occurred 4 to 12 months after HT. The main clinical manifestations were fatigue, loss of appetite, and palpitation after exercise and irritability. One patient died. In one case chronic rejection occurred 13 months after HT, the clinical manifestations included increased heart rate and peripheral blood lymphocyte count. Seven of the 27 patients (25.9%) developed renal injury. The main clinical manifestations were decline in creatinine clearance, rise in serum urea, creatinine and potassium, and hyperuricemia. The renal injury occurred in 3, 2, and 2 patients within 1 month, 3 to 6 months and 7 to 12 months after HT, respectively. One patient (3.7%) developed liver injury 2 months after HT, the clinical manifestations were increased levels of alanine aminotransferase (ALT) and total bilirubin (TBil).The levels of total cholesterol, LDL-cholesterol, and triglycerides increased in 18 patients (66.7%), occurred in 17 and 1 patients within 3 months and 7 to 12 months after HT, respectively. The levels of fasting plasma glucose increased in 10 patients (37.0%) and occurred in 7, 2 and 1 patients within one month, 4 to 12 months, and 18 months after HT, respectively. C0 and C2 in patients with non-rejection were significantly higher than those with acute rejection [(216±90) μg/L vs. (167±103) μg/L, (718±297) μg/L vs. (472±251 ) μg/L, all P<0.01]. C0 and C2 in patients with adverse reactions were significantly higher than those without adverse reactions [(241±93) μg/L vs. (190±95) μg/L, (837±314) μg/L vs. (596±283) μg/L, all P<0.01]. C0 was related to the blood serum urea, the creatinine, and the fasting plasma glucose (r=0.359, P=0.000; r=0.170, P=0.014; r=0.164, P=0.018). C0 and C2 were related to the TBil,TC, and LDL-C (r=0.182, P=0.009; r=-0.170, P=0.018; r=0.267, P=0.001; r=0.320, P=0.000; r=0.251, P=0.001; r=0.275, P=0.000). ConclusionsThe CsA blood concentration in patient after HT is closely related to the occurrence of rejection and adverse reactions. Monitoring of CsA blood concentration is helpful to adjust the dose of CsA timely in order to reduce the incidence of rejection and adverse reactions.

  • 病例报告
    YI Shu-zhen
    . 2012, 14(1): 42-2.

    An 88-year-old male, received clopidogrel sulfate, aspirin, metoprolol tartrate, telmisartan, simvastatin, dalteparin sodium and nitroglycerin for acute coronary syndrome. On day 5 of treatment, the dosage of simvastatin was increased from 20 mg every night to 40 mg every night. On day 8, telmisartan was stopped and amlodipine besylate and diltiazem 15 mg thrice daily were added. On day 42, the patient developed severe skeletal muscular weakness and myalgia. Laboratory tests revealed the following levels: creatine kinase(CK) 8100 U/L, creatine kinase-MB 305 U/L, troponin 0.046 μg/L, alanine aminotransferase (ALT) 102 U/L, aspartate aminotransferase (AST) 151 U/L. Simvastatin was stopped and he was given by an IV infusion of tiopronin. On day 16 of simvastatin withdrawal, repeat biochemical blood tests revealed the following levels: CK 55 U/L, ALT 13 U/L, and AST 14 U/L. Eight days later, simvastatin 10mg every night was administered again combined with diltiazem 30 mg thrice daily. Abnormalities of CK and liver function tests were not seen with a 22-day of treatment.

  • 病例报告
    Zhang Renlinga;Qi Yingb
    . 2010, 12(3): 221-1.
    A 66yearold woman with hyperthyroidism received levothyroxine sodium 50 μg once daily for three years. She was recently diagnosed with type II diabetes. Repaglinide 1 mg twice daily was added to her regimen.One week later, the patient developed unconsciouness. Laboratory testing showed a blood glucose level of 2.3 mmol/L. Hypoglycemia was diagnosed and repaglinide was stopped. Glucose injection was given. Her blood glucose levels increased to 3.9,5.1, and 8.7 mmol/L. Her consciouness gradually recovered. Her repaglinide therapy was replaced with neteglinide 120 mg thrice daily. And her hypoglycemia did not recur
  • 中药不良反应
    Fu Xiaoda;Fu Cuili;Li Cuiling
    . 2011, 13(5): 324-2.

    Two patients developed eye disorders after receiving 6 Zhuanggushenjin capsules thrice daily for loin and leg pain. Patient 1, a 51-year-old man, developed blurred vision, conjunctival hyperemia, subconjunctival hemorrhage and decreased vision at week 10 of treatment. The medicine was stopped. He was given symptomatic treatment and his ocular symptoms improved. Half a year later, the patient 1 took Zhuanggushenjin capsules again, and his decreased vision and conjunctival hyperemia as well as diplopia recurred. His symptoms relieved after drug discontinuation, but his left-eye diplopia remained so on follow-up after one year. Patient 2, a 76-year-old woman, developed dry eye, blurred vision, conjunctival hyperemia and subconjunctival hemorrhage at week 2 of treatment. The medicine was discontinued and her symptoms disappeared and her vision improved after symptomatic treatment.

  • 病例报告
    Sun Xin;Zhou Jie;Jiang Sunmin;Yao Ying;Zhang Yan
    . 2014, 16(5): 306-2.
    A 43-year-old woman received one tablet of ethinylestradiol and cyproterone acetate (containing cyproterone acetate 2 mg and ethinylestradiol 0.035 mg in one tablet) once daily for dysfunctional uterine bleeding. The patient took the drug regularly. On day 9, she developed generalized iris-like erythema with itching and the drug was stopped. The next day, the area and number of iris-like erythema increased and accompanied by severe itching and pain, the rashes on her face fused into lamella pattern and her face swelled significantly. It was diagnosed as multiform erythema induced by drugs. Mizolastine, loratadine and diammonium glycyrrhizinate were given orally and compound betamethasone was given with a single intramuscular injection. On the day 3, the patient received an IV injection of dexamethasone sodium phosphate 5 mg+5% glucose injection 500 ml and diammonium glycyrrhizinate and sodium chloride injection 150 mg (250 ml) once daily. Topical application of triamcinolone acetonide econazole nitrate cream was given at the same time. Eight days later, her symptoms alleviated and erythema gradually subsided.
  • 病例报告
    Yuan Yue;Zhang Qun
    . 2014, 16(1): 42-2.

    A 90-year-old male patient with hypertension and vascular dementia was treated with amlodipine besilate, donepezil hydrochloride and olanzapine. Oral topiramate 25 mg twice daily was added to his regimen due to irritability and other abnormal mental status and behaviors. On day 22 of treatment with topiramate, he developed generalized flushing. An infusion of methylprednisolone 20 mg once daily was given. After 13 days, diffuse erythema involving his entire body with pruritus and partial plaques fusion developed. His symptoms progressed to large areas of skin exfoliation after 5 days. Exfoliative dermatitis was diagnosed. Topiramate was stopped and he was treated with methylprednisolone double dosage and topical zinc oxide lotion. At the same time, he received symptomatic treatment and supportive therapy such as anti-inflammatory and albumin supplement. Twelve days later, patient′s rash subsided.

  • hang Chuan, Zhang Lingli, Wang Xiaodong, Lang Bingchen, Liu Dan, Li Jialian
    . 2015, 17(3): 175.
  • Cai Haodong
    Adverse Drug Reactions Journal. 2021, 23(1): 2-5. https://doi.org/10.3760/cma.j.cn114015-20210113-00052
    The coronavirus disease 2019 (COVID-19) epidemic is facing the most critical situation. As of January 11, 2021, there have been nearly 90 million confirmed cases worldwide and nearly 2 million deaths. The local epidemic situation in China is sporadic and locally clustered, and the situation of epidemic prevention is difficult and complicated. In this situation, there are many problems in medication safety of patients, such as safety issues in off-label medication and compassionate medication of COVID-19 treatment, safety problems in the combination use of drugs for COVID-19 and drugs for other diseases, monitoring of adverse drug reactions in COVID-19 treatment, the safety issues in self-purchased drugs for prevention and treatment of COVID-19, and the medication safety in patients with other diseases during the epidemic. Therefore, it is necessary to pay more attention to the medication safety of patients to fight the epidemic scientifically and to win a greater victory in the fight against the COVID-19 epidemic at a smaller price.
  • Chu Min, Liu Aihua
    Adverse Drug Reactions Journal. 2020, 22(4): 262-264. https://doi.org/10.3760/cma.j.cn114015-20190327-00295
    Three patients with epilepsy (patient 1, a 60-year-old female with a history of heart disease; patient 2, a 29-year-old male; patient 3, an 18-year-old male) received oxcarbazepine orally for epileptic seizures (patient 1 received 0.3 g twice daily; patient 20.45 g twice daily; patient 3-0.6 g twice daily). Intermittent syncope or palpitations occurred in patient 1, 2, and 3 on day 4, 5, and 1 after medications, respectively. All 3 patients showed arrhythmias in electrocardiograms. Patient 1 developed atrial fibrillation, cardiac arrest, degree III sinoatrial block, degree II type II atrioventricular block; patient 2 and 3 deve- loped different degrees of atrioventricular block. Above-mentioned arrhythmias were considered to be cardiotoxicity caused by oxcarbazepine. In patient 1, the number of syncope was reduced from 2 to 3 times per day to 1 time per day after 3 days of oxcarbazepine withdrawal, but the electrocardiogram still showed degree II type II atrioventricular block. Then no syncope recurred after implantation of heart pacemaker. In patient 2, no syncope recurred after 5 days of oxcarbazepine withdrawal. In patient 3, no palpitations recurred after reduction of oxcarbazepine to 0.45 g twice daily and addition of other antiepileptic drugs for 2 days.
  • Mu Hong, Wang Lili, Li Jun
    Adverse Drug Reactions Journal. 2020, 22(2): 119-120. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.016
    A 75-year-old female patient received an intravenous infusion of moxifloxacin hydrochloride injection 0.4 g for prevention of infections after lumbar operation. About 10 minutes later, the patient developed sudden general discomfort, wet and cold skin, drenching sweats. Meanwhile her heart rate was 130 beats/min, breath rate was 26 times/min, and blood pressure was 57/37 mmHg. Anaphylactic shock caused by moxifloxacin was considered. Moxifloxacin was stopped immediately, ECG monitoring and oxygen inhalation through nasal catheter were given. Then, intravenous injection of adrenaline hydrochloride injection 0.5 mg, furosemide injection 10 mg, nitroglycerin injection 2.5 mg, and sublingual metoprolol tartrate tablet 12.5 mg were given successively. After 80 minutes, the patient′s symptoms relieved, with heart rate 88 beats/min, breath rate 18 times/min, and blood pressure 95/54 mmHg.
  • Li Xianchao, Li Jing, Ren Jixia, Lu Yan, Han Maozhi, Li Shenghui, Li Shasha
    Adverse Drug Reactions Journal. 2020, 22(2): 113-115. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.013
    A 62-year-old male patient received propacetamol hydrochloride for analgesia, cefuro- xime sodium for anti-infection, adenosine cobalamin for nutrition of nerve, and low molecular weight heparin calcium for anticoagulation for burst fracture of the third lumbar vertebra and multiple fractures of transverse process of lumbar spine caused by traffic accident. The patient′s liver function was normal before medication. He underwent the operation under general anesthesia 2 days later. Low molecular weight heparin calcium was stopped before the operation. On day 3 after the operation (on day 5 of medication), the patient developed abdominal distension and pain. The results of laboratory tests showed alanine aminotransferase (ALT) 9 315 U/L, aspartate aminotransferase (AST) 10 760 U/L, gamma glutamyltransferase (γ-GT) 47 U/L, alkaline phosphatase (ALP) 101 U/L, total bilirubin (TBil) 71.3 μmol/L, direct bilirubin (DBil) 48.5 μmol/L, and indirect bilirubin (IBil) 22.8 μmol/L. Drug-induced liver injury was considered. Propacetamol hydrochloride was discontinued and liver-protective drugs were given. The next day, the patient developed yellow staining of his sclera and whole body skin, then followed by confusion, decreased blood oxygen saturation, low blood pressure, and hypoglycemia. The results of reexamination showed ALT 5 975 U/L, AST 3 659 U/L, γ-GT 100 U/L, ALP 141 U/L, TBil 175.2 μmol/L, DBil 101.4 μmol/L, IBil 73.8 μmol/L, and prothrombin time 21.2 s. The patient was diagnosed as acute liver failure. Cefuroxime sodium and adenosine cobalamin were discontinued and symptomatic and supportive treatments such as increasing blood pressure, fluid supplement, and correction of acidosis were given. However, the patient′s condition was not improved. He was transferred to other hospital on the same day. On the 4th day, he died of multiple organ failure.
  • 病例报告
    LIU Jun
    . 2012, 14(6): 393-2.
    A 62-year-old male patient received combined therapy with aspirin 0.1 g once daily and warfarin 3.0 mg once daily for prevention of thrombosis after undergoing aortic valve replacement. On day 5 of treatment, he presented with vague pain in the upper abdomen. On day 14, his abdominal pain worsened and, on day 15, he presented with melena. Laboratory tests showed the following values: red blood cell count 2.2×1012/L, hemoglobin 65 g/L, prothrombin time (PT) 45.9 s, international normalized ratio (INR) 3.7, fecal occult blood (++). Gastroscopy revealed gastric ulcer with hemorrhage. Aspirin and warfarin were withdrawn, and then the patient was given hemostatic and symptomatic treatment. On day 2, the patient’s abdominal pain was relieved and hemorrhage ceased. His PT decreased to 12.8 s and his INR decreased to 1.1 one week later. The patient resumed the anticoagulation treatment with warfarin.
  • 病例报告
    JIA Su-jie;ZHANG Xiao-juan;YANG Min
    . 2013, 15(1): 44-2.
    ZHANG Xiao-juan, Department of Pharmacy, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510080, China, Email: xiaojuanzhang@yahoo.com.cn【Abstract】A 56-year-old man with acute myocardial infarction underwent coronary arteriongraphy and percutaneous coronary intervention (PCI) after receiving regular treatment with oral aspirin and clopidogrel for 2 months. His platelet count was 185×109/L before PCI. Unfractionated heparin was given during the operation and an continuous IV infusion of tirofiban [0.1 μg/(kg·min)]was given for 36 hours via a micropump after PCI. About 12 hours after starting tirofiban, the patient presented with sporadic ecchymoses on both upper extremities and the platelet count decreased to 5×109/L. Tirofiban, aspirin, and clopidogrel were withdrawn immediately and dexamethasone was given. On day 4 after PCI, clopidogrel was given again. On day 5 after PCI, aspirin was resumed. On day 6 after PCI, his ecchymoses disappeared and the platelet count returned to normal level. The patient′s severe thrombocytopenia was considered to be induced by tirofiban.
  • HUANG Yu-ming;QIN Kai-yu;ZHAN Han-qiu;Qi Yan-yun;XU Dong-mei;JIANG Mei-juan;XUE Cheng-lian;GAO Jun-hua;ZHANG Lei
    . 2013, 15(6): 351-2.
    A 67-year-old male patient with cerebral infarction and depression received paroxetine 20 mg once daily. Five days later, the patient developed fatigue, apathy and loss of appetite. Laboratory test showed a serum sodium level of 128 mmol/L. His serum sodium level was 136 mmol/L before paroxetine therapy. Paroxetine was discontinued and changed to flupentixol and melitracen, and oral saline was administered. One week later, the level of serum sodium returned to 134 mmol/L and his clinical symptoms were improved. One month later, his serum sodium level was 142 mmol/L.
  • 病例报告
    . 2007, 9(1): 49-50.
  • 药物评介
    . 2000, 2(1): 62-64.
  • ADR监测与防治
    . 2000, 2(2): 108-108.
  • 不良事件
    . 2002, 4(2): 129-129.
  • 综合报道
    . 2001, 3(4): 240-243.
    本文概述了近年来文献报道卡托普利在临床应用中引起循环系统、呼吸系统、泌尿系统、消化系统、血液系统、代谢系统及其他不良反应,提示临床使用时尚须注意。
  • 病例报告
    . 2000, 2(2): 124-125.
  • 病例报告
    . 2005, 7(3): 216-216.
  • 病例报告
    . 2005, 7(3): 195-195.
  • 不良事件
    . 2005, 7(2): 147-147.
  • 不良事件
    . 2005, 7(1): 67-67.
  • 综合报道
    . 2001, 3(1): 36-37.
  • 病例报告
    . 2002, 4(5): 334-335.
  • 不良事件
    . 2005, 7(5): 388-389.
  • 安全信息
    . 2008, 10(3): 221-2.
  • 国外文献题录
    . 2002, 4(5): 349-350.
  • 病例报道
    . 1999, 1(1): 62-62.
  • 病例报告
    Wang Nan;Ni Jianghong;Zhou Xiaodong;Xie Xuejian;Zhang Zheng
    . 2009, 11(1): 56-2.
    A 48yearold man with hyperthyroidism took propylthiouracil 100 mg once daily for 5 years or more. He developed leukopenia during treatment. Despite treatment with drugs used in leukopenia, his leucocyte level was still lower than the normal range. Recently, the man presented with dry cough, fever, and chill. His body temperature peaked at 39.6℃. Penicillin was administered for 3 days, but his fever remained. A chest CT scan revealed inflammation of the lungs. He was treated successively with ceftriaxone and azithromycin, but his cough and fever still remained. After admission, his temperature was 38.3℃, and laboratory investigations revealed the following levels: CRP 98.0 mg/L, ASO 505.0 U/ml,high sensitivity CRP 84.2 mg/ml, IgG 18.9 g/L, immunoglobulin κ light chain 16.7 g/L,CA125 108.9 U/ml,antiendothelial cell antibody (AECA) titre 1:10,antinuclear antibody titre 1:320, His antineutrophil cytoplasmic antibody was positive. Pulmonary smallvessel vasculitis was considered to be propylthiouracilassociated. The medication was withdrawn. IV levofloxacin, IV cefoperazonetazobactam, and oral prednisone were administered. Three days later, his symptoms markedly improved.
  • 不良事件
    . 2004, 6(6): 392-392.
  • 病例报告
    . 2006, 8(4): 295-295.
  • 中毒救治
    . 2006, 8(4): 285-285.
  • 不良事件
    . 2006, 8(3): 222-222.
  • 病例报告
    . 2003, 5(2): 115-115.
  • Dai Hengfen, Xiao Jingwen, Ouyang Yu, Hou Haijuan, Zheng Caiyun, Zhang Yan
    Adverse Drug Reactions Journal. 2023, 25(12): 761-763. https://doi.org/10.3760/cma.j.cn114015-20230419-00287
    A 17-year-old female patient developed fever after novel coronavirus infection and took ibuprofen sustained-release capsules 0.3 g 4 times within 3 days by herself. During the medication, the patient developed the symptoms such as chest tightness, shortness of breath, limbs fatigue, sweating, muscle soreness, and dark urine successively. Laboratory tests showed creatine kinase (CK) 583-800-U/L, CK-MB 45-μg/L, lactate dehydrogenase 4-772-U/L, serum creatinine (Scr) 392-μmol/L, myoglobin 87-μg/L, and urea nitrogen 32.8-mmol/L. It was considered that rhabdomyolysis with acute kidney injury might be related to ibuprofen. The patient was given symptomatic treatments such as renal replacement therapy, hemodialysis, blood transfusion, rehydration, diuresis, etc. Thirty-three days later, the patient′s muscle soreness and other symptoms disappeared, the urine color returned to normal, laboratory tests showed CK 168-U/L, myoglobin 24-μg/L, and Scr 52-μmol/L.
  • 病例报告
    . 2006, 8(3): 211-212.
  • 病例报告
    . 2006, 8(3): 212-213.
  • 病例报告
    . 2003, 5(4): 259-259.
  • 病例报告
    . 2003, 5(4): 264-264.
  • 病例报告
    . 2006, 8(6): 450-451.
  • 综合报道
    . 2001, 3(3): 176-178.
    Infliximab是一种肿瘤坏死因子(TNF)阻滞剂,用于治疗中、重度的克罗恩氏病及顽固性类风湿性关节炎。本文重点介绍了infliximab在美国及欧盟上市的情况、临床试验中以及上市后发生的不良反应的情况,同时也与另一种治疗顽固性类风湿性关节炎的TNF阻滞剂etanercept进行了简单地比较。
  • 不良事件
    . 2004, 6(5): 293-293.
  • 病例报告
    . 2003, 5(4): 281-281.
  • 病例报告
    . 2002, 4(1): 43-43.
  • 中药不良反应
    Hu Wei;Shi Shaohong;Yang Jiayao
    . 2008, 10(6): 0-0.

    A 35-year-old woman was hospitalized with worsening of generalized rash. Before admission, she had taken Baixuanxiatare tablets for one year. After hospitalisation, she received monoammonium glycyrrhizinate, chlorphenamine, diphenhydramine, and acitretin. Four days after admission, because of bloody stools, she underwent enteroscopy, which revealed a dark brown colic mucous membrane. Colon biopsies showed the presence of pigmentladen mononuclear phagocytes within the lamina propria. Melanosis coli was diagnosed. Baixuanxiatare tablets were discontinued and other drugs were continued. One year later, a repeated enteroscopy revealed normal mucosa in the colon. Melanosis coli might be associated with anthraquinonecontaining aloe in Baixuanxiatare tablets.

  • Gao Jie;Xie Cheng;Miao Liyan
    Adverse Drug Reactions Journal. 2009, 11(4): 282-2.
    A 50yearold man with lung adenocarcinoma received an IV infusion of omeprazole 40 mg and an IV infusion of ondansetron 8 mg for prevention of vomiting before chemotherapy. About 15 minutes after ondansetron infusion start, the patient developed rash on his chest and arms. Ondansetron was stopped and dexamethasone and promethazine were given. Forty minutes later, the rash progressed to involve his entire body, and blurred vision, cold sweat, chest distress, asthenia, weak pulse, and muffled heart sounds occurred. Physical examination showed a HR of 75 beats/min and a BP of 50/40 mm Hg. The patient was treated with oxygen inhalation, SC adrenaline, an IV push of dexamethasone, and an IV infusion of dopamine. His symptoms relieved, and 5 hours later, his vital signs became stable.
  • 病例报告
    Cui Baozhu
    . 2009, 11(3): 214-2.

    An 87yearold man was hospitalized with lung metastasis of renal cancer complicated by lung infection. After admission, his ECG showed atrial premature beats with occasional ventricular premature beats. The patient was treatment with ceftizoxime and levofloxacin. On day 5 of hospitalization, he received an IV infusion of recombinant human interleukin-2 21 million units in 0.9% sodium chloride 100 ml. The next day, the patient developed paroxysmal atrial fibrillation. Initially, 2-3 episodes occurred every day and each episode lasted for 1-2 minutes. Four days later, multiple episodes occurred and each episode sometimes lasted for 10 minutes and more. Propafenone 100 mg thrice daily was given by mouth, but this had no obvious effect. Atrial fibrillation was considered to be possibly recombinant human interleukin-2-associated. Recombinant human interleukin-2 was stopped immediately. Subsequently, his ECG did not reveal any atrial fibrillation.

  • 病例报告
    . 2001, 3(1): 46-46.
  • 监测简报
    . 2004, 6(2): 126-127.
  • 病例报告
    . 2001, 3(2): 119-120.
  • 病例报告
    . 2003, 5(1): 49-49.
  • 病例报告
    . 2003, 5(1): 43-44.
  • 病例报告
    . 2006, 8(2): 131-132.
  • 不良事件
    . 2005, 7(2): 154-154.
  • 病例报告
    . 2004, 6(3): 169-169.
  • 安全用药
    . 2001, 3(1): 32-34.
  • 病例报告
    . 2001, 3(4): 256-256.
  • 网络医药
    . 2003, 5(5): 326-330.
  • 不良事件
    . 2005, 7(1): 31-31.
  • WHO信息
    . 2002, 4(4): 276-276.
  • 病例报告
    HANG Yong-fu;GAO Jie
    . 2012, 14(6): 384-2.
    A 31-year-old woman received allopurinol 0.1 g twice daily and colchicine 1.0 mg once daily orally for acute gout. Fifteen days later, the patient developed gross. Routine urine tests revealed urine occult blood (+++), urinary protein(+), LEU-U(+), RBC 4439/μl, WBC 921/μl. Allopurinol and colchicine were withdrawn immediately. Anti-infective and hemostatic treatments were given. On day 10 after drug withdrawal, Routine urine tests revealed urine occult blood (++), urinary protein (-), RBC 2-4/μl, WBC 0/μl. On day 16 after drug withdrawal, Routine urine tests revealed urine occult blood (-), urinary protein (-), RBC 1/μl, WBC 0/μl.
  • 病例报告
    Li Xueqin;Li Yingran
    . 2011, 13(6): 380-3.
    Three infants (patient 1, a 2-day-old male infant; patient 2, a 41-day-old female infant; patient 3 a 1-day-old male infant) were administered human immunoglobulin in doses of 2.5 g, 2.5 g, and 1.25 g by IV infusion for enhancing immunologic function, respectively. Two hours after completion of the infusion, their blood glucose increased to 11.0, 9.6, and 8.0 mmol/L, respectively. Subsequently, their blood glucose returned to the normal range within 24 hours. However, patient 1 redeveloped hyperglycemia and his blood glucose reached 10.1 mmol/L after repeated infusion of human immunoglobulin 2.5 g. Ten hours later, his blood glucose fell to 5.0 mmol/L without treatment.
  • 病例报告
    Zhang Haiying;Liu Yi;Li Yuzhen
    . 2011, 13(2): 120-2.
    A 72yearold woman received combined therapy with warfarin and nadroparin calcium for suspected pulmonary embolism, and the international normalized ratio (INR) was stable at 1.23-2.81. Eight days after combination therapy, nadroparin calcium was stopped and warfarin 3 mg/d alone was given. Two days later, her INR was 3.31. A sputum culture test showed Candida albicans, and an IV infusion of fluconazole 0.4 g once daily was added to her regimen,while warfarin was adjusted to 1.5mg/d. On days one and six of combination therapy with fluconazole and warfarin, her INR was 3.91 and 7.31, respectively. Warfarin was immediately withdrawn and fluconazole was continued according to the original dose. At the same time, the patient received IM vitamin K1 40 mg. On days 1, 2, and 3 after warfarin withdrawal, her INR decreased to 4.91, 2.01, and 1.30, respectively. On day 5 after drug withdrawal, the patient was readministered warfarin 1.5 mg/d and fluconazole was adjusted to 0.2 g/d simultaneously. On day 4 of combination therapy, her INR was 1.68.
  • 病例报告
    Ouyang Hua
    . 2011, 13(2): 113-2.
    A 61-year-old male patient with small cell lung cancer received SC recombinant human interleukin -11(rhIL-11) 3 mg once daily for thrombocytopenia which occurred during chemotherapy. On day 5 of drug therapy, the patient presented with mild edema in his lower extremities, which progressed to a severe edema on day 7. The edema was considered to be related to rhIL-11.The drug was discontinued immediately. The man received diuretic therapy with hydrochlorothiazide and spironolactone. Two days after drug withdrawal, his edema gradually diminished and then subsided. Two months later, his thrombocytopenia recurred. SC rhIL-11 3 mg/day was readministered. Five days after initiation of rhIL-11, mild edema in his lower extremities recurred. His edema subsided two days after discontinuation of rhIL-11.
  • 中毒救治
    Liao Qiuju;Wang Jing;Xing Xiurong;Qin Jian;Wang Changyuan
    . 2010, 12(4): 278-2.
    A 24yearold woman took 70 tablets of phenformin 25 mg. One day later, the patient experienced vomiting, abdominal pain, diarrhea, dyspnea, delirium, agitation, unconsciousness, and no response to voice stimuli. Her blood pressure was 70/39 mm Hg and heart rate was 114 beats/min. The laboratory examinations revealed the following levels and values: glucose 0.06 mmol/L, lactic acid 32.51 mmol/L, SCr 169 μmol/L, pH 6.89, PCO2 20 mm Hg, PO2 71.2 mm Hg, SaO2 0.913, BE -19.8 mmol/L, and HCO3- 16.5 mmol/L. She was given an IV push of 50% glucose 40 mL, and an IV infusion of 5% sodium dicarbonate 250 mL, fluid supplementation, ventilator support, hemofiltration, and other treatments. Four days later, the patient returned to normal consciousness and spontaneous respiration and, 10 days later, she recovered and was discharged.
  • Dai Ting, Pan Wenlan, Guo Junping
    . 2018, 20(1): 63.
    A 52-year-old women with multiple metastasis of cervical cancer started to receive the targeted therapy with apatinib (250 mg daily).  Five months later,the patient developed chest tightness and shortness of breath.  The symptoms were not relieved after oxygen and intravenous methylprednisolone 40 mg were given.  Ninety minutes later, the patient developed dyspnea, cough, pinky foam sputum, bilateral lower pulmonary rales, and elevated myocardial enzymes.  An intravenous bolus of Cedilanid 0.3 mg and furose-mide 20 mg were given,and her  symptoms were relieved.  Apatinib was discontinued,and she was treated with glyceryl trinitrate 10 mg,aspirin 0.1g daily,clopidogrel 75 mg daily,atorvastatin calcium 20 mg daily,and metoprolol 12.5 mg twice daily.  The patient′s symptoms were relieved at day 2 after treatment.  The myocardial enzymes declined gradually,and it returned to normal 12 days later. Two months after apatinib withdrawal,the symptoms of acute left heart failure did not reccur.
  • Wu Ruiqin
    . 2015, 17(3): 222.
    A 2-year-old girl with bronchopneumonia received an IV infusion of  sodium fusidate 125 mg in 0.9% sodium chloride 100 ml once daily. On day 5, extravasation of liquid medicine was found on left opisthenar when 80 ml liquid medicine was infused. The swelling area on the back of left hand was about 3.0 cm×3.5 cm. The IV infusion was stopped immediately and magnesium sulphate hydropathic compress and mucopolysaccharide polysulfate cream were given. The swelling on back of left hand was subsided evidently nine days later. There was no symptom of necrosis in local skin. The parents found that tendon adhesion in girl′s third, fourth and fifth fingers 36 days after extravasation. The girl could not do the action of taking object by hand. The girl received the lysis of adhesions of tendon on the third, fourth and fifth fingers. The girl performed physical exercise for three months after operation. The follow-up result showed that the girl′s hand function were well recovered on 6 months after operation.
  • 病例报告
    Yang Jingxiu;Ge Shengrong
    . 2014, 16(2): 126-3.

    Two male infants (aged 5 months and 19 days, and 3 months and 19 days, respectively) were given an intravenous infusion of ceftriaxone sodium 0.7 g in 0.9% sodium chloride 100 ml once daily and an intravenous infusion of ceftriaxone sodium 0.6 g in 0.9% sodium chloride 50 ml once daily for bronchitis and infectious diarrhea, respectively. On day 10 and 4, white granules were found on skin surface of the two infants′oschea. There were no inflamed urinary meatus and abnormal results of routine urine tests. The white granules gradually decreased and disappeared after ceftriaxone sodium was withdrawn.

  • Ding Zheng, Wang Ranran, Feng Shoujun, Zheng Yingli
    . 2016, 18(3): 201.
    New oral anticoagulants(NOAC) including dabigatran, rivaroxaban, apixaban and edoxaban have been widely used clinically. These drugs are the direct coagulation factor inhibitor. They have the stable pharmacokinetics so that patients don′t require routine coagulation monitoring. They can be administrated in fixed doses and have few drug interactions. NOAC have been recommended in 2014 guideline for the management of patients with atrial fibrillation by American Heart Association, American College of Cardiology and Heart Rhythm Society. NOAC can be a replacement in patients who have contraindications for warfarin. The dose-adjustment of NOAC is based on the particular pharmacokinetic characteristics and kidney function of the elderly. Pharmaceutical care plan is helpful to increase the safety and efficacy of the medication in the elderly.
  • Li Danni, Ding Wenwen, Wei Pingping, Zhang Lei, Liang Hui
    . 2017, 19(3): 174.
    ObjectiveTo explore the influence of pegaspargase on coagulation function in children with acute lymphocytic leukemia (ALL).MethodsMedical records of children with ALL and receiving pegaspargase treatments from May 2013 to May 2016 in Qingdao Women and Children′s Hospital were collected and retrospectively analyzed. The children all received pegaspargase treatments after complete remission with induction therapy. The levels of activated partial thromboplastin time (APTT), prothrombin time (PT), and fibrinogen (FIB) before and after pegaspargase treatments (on the 5th, 10th, 15th, 20th, and 25th days) were analyzed, the occurrence of hemorrhage and thrombosis and the outcome of the children with abnormal coagulation function were observed.ResultsA total of 30 patients were entered in this study and received 69 pegaspargase treatments. Coagulation indicators were abnormal in 30 patients (100%) and 68 cases of pegaspargase treatments (98.6%), of them, only APTT prolonged in 1 patient (3.3%) and 4 cases of pegaspargase treatments (5.8%), only FIB decreased in 5 patients (16.7%) and 19 cases of pegaspargase treatments (27.5%), and both APTT and FIB were abnormal in 19 patients (63.3%) and 40 cases of pegaspargase treatments (58.0%). APTT, FIB and PT were all abnormal in 5 patients (16.7%) and 5 cases of pegaspargase treatments (7.2%). Abnormal APTT and FIB appeared on the 5th day after the pegaspargase treatments in 35 and 54 cases of pegaspargase treatments, respectively. Abnormal PT appeared on the 10th day of pegaspargase treatments. The levels of APTT were (37±4), (51±7), (55±11), and (46±11) s (F=41.31, P<0.01); the levels of FIB were (2.6±0.5), (1.1±0.3), (0.9±0.4), and (1.5±0.8) g/L (F=125.31, P<0.01), there were statistically significant differences between the different time points (P<0.01). None of the patients developed hemorrhage or thrombosis, and the abnormality of coagulation function did not affect the chemotherapy.ConclusionPegaspargase could influence the coagulation function of ALL children, especially hypofibrinogenemia and prolonged APTT, which is not serious in most cases and no hemorrhage or thrombosis occurred.
  • Li Shuang
    . 2016, 18(6): 464.
    A 74 year old male patient received an IV infusion of tigecycline 50 mg per 12 hours because of septic shock induced by diverticulum of small intestine complicated with perforation after surgery. Before IV infusion, the results of laboratory test showed the following valumes: total bilirubin (TBil) 11.1 μmol/L, direct bilirubin (DBil) 2.3 μmol/L, indirect bilirubin (IBil) 8.2 μmol/L. On day 4 of drug administration, the results of laboratory test showed the following volumes: TBil 99.1 μmol/L, DBil 48.1 μmol/L, IBil 32.3 μmol/L. On day 6 of drug administration,  the patient developed yellow scle, the results of laboratory test showed the following volumes: TBil 206.3 μmol/L, DBil 126.7 μmol/L, IBil 45.4 μmol/L. Tigecycline was stopped. On day 4 of drug withdrawal, the results of laboratory test were TBil 167.4 μmol/L, DBil 98.2 μmol/L, IBil 36.1μmol/L. Two weeks later, TBil was 18.3μmol/L, DBil 3.4 μmol/L, IBil 11.6μmol/L.
  • Liu Lihua, He Xin, Ma Hongling, Chen Shenjue, Zhang Mingxiang
    . 2017, 19(4): 293.
    A 76-year-old man with bronchopneumonia received an IV infusion of ceftizoxime sodium 2 g twice daily. Before treatment, laboratory tests showed the following results: white blood cell count (WBC) 10.8×109/L, neutrophil 0.94, red blood cell count (RBC) 3.8×1012/L, hemoglobin (Hb) 121 g/L, total bilirubin (TBil) 12.6 μmol/L, indirect bilirubin (IBil) 8.7 μmol/L, serum creatinine (Scr) 151 μmol/L, blood urea nitrogen (BUN) 10.7 mmol/L, endogenous creatinine clearance rate 35 ml/min. On day 11, about 10 minutes after beginning infusion of the 22nd dosage of ceftizoxime, he developed low back pain with bladder distending pain and yellowish skin and sclera. Ceftizoxime sodium was withdrawn immediately. Urethral catheter drained soy sauce-colored urine 200 ml. Laboratory tests revealed the following results: WBC 15.7×109/L, neutrophil 0.68, RBC 1.1×1012/L, Hb 73 g/L, reticulocytes 0.023, TBil 83.8 μmol/L, IBil 61.8 μmol/L, Scr 127 μmol/L, BUN 11.9 mmol/L, D-dimer 9.8 mg/L, direct Coomb′s test positive, urine bilirubin (++), occult blood (++), 2-3 red blood cells per high power field. He received treatments such as hydration and urinary alkalinization, infusion of methylprednisolone, transfusion of washed red blood cells and etc. However, he had sustained low urine output, progressive jaundice, and finally died 8 hours later. Acute hemolytic anemia was considered to be induced by overdose of ceftizoxime sodium.
  • 病例报告
    Liu Jun;Wei Jun
    . 2014, 16(3): 181-2.
    A 63-year-old male patient received anticoagulation therapy with a SC injection of enoxaparin sodium 4 000 U twice daily on the first day after mitral valve and aortic valve replacement. His platelet counts were within normal range before surgery and on the first day after surgery. On day 2 after surgery,his platelet count decreased to 41×109/L and a SC injection of recombinant human interleukin-11 15 mg once daily was given. On day 3 after surgery,his platelet count was 22×109/L. Enoxaparin sodium was withdrawn. On days 4 and 5,the platelet counts increased to 45×109/L and 59×109/L,respectively. On day 6, his platelet count was 128×109/L.
  • Su Na, Xu Jiayue, Xu Ting
    . 2015, 17(6): 420-427.
    ObjectiveTo evaluate the safety of exenatide treatment in patients with obesity or overweight.MethodsCochrane library, PubMed, Embase, CNKI, VIP,  and Wanfang databases were searched. Randomized controlled trails (RCT) of exenatide treatment and comparison with placebo and other hypoglycemic agents in patients with obesity or overweight (with or without type 2 diabetes) were selected and Meta-analyses were performed using Revman 5.3.0 software. The safety was evaluated by the incidences of common and serious adverse drug reactions. The results were expressed as relative risk(RR) and 95% confidence interval (CI).ResultsA total of 25 RCTs and 5 307 patients with obesity or overweight were entered in this study. The incidence of common adverse drug reactions in the exenatide group was lower than that in the taspoglutide group [89.1% (343/385) vs. 93.9% (370/394), RR=0.95, 95%CI: 0.91-0.99, P=0.02], and higher than that in the insulin group [74.3% (473/637) vs. 60.0% (362/603), RR=1.22, 95%CI: 1.06-1.41, P=0.01]. The differences between the exenatide group and the placebo or metformin groups were not statistically significant (both P>0.05). The results of the incidence of single adverse drug reaction were as follows. The incidences of mild hypoglycemia, nausea, vomiting, diarrhea,  constipation, and headache in the exenatide group were higher than those in the placebo group (P<0.01, P<0.01, P<0.01, P<0.01, P<0.01, and P=0.02); the incidences of nausea, vomiting, diarrhea, and constipation in the exenatide group were higher than those in the insulin group (P<0.01, P<0.01, P<0.01, P=0.02); the incidence of diarrhea in the exenatide group was lower than that in the metformin group (P=0.01); the incidence of nausea in the exenatide group was higher than that in the rosiglitazone group (P=0.01); the incidences of nausea, vomiting, and constipation in the exenatide group were lower than those in the taspoglutide group (P=0.02, P<0.01, P<0.01); the incidences of nausea, vomiting, and diarrhea in the exenatide group were higher than those in the sitagliptin group (P=0.01, P<0.01, P=0.03). The differences of the incidence of serious adverse reactions in the exenatide group and the placebo, insulin, taspoglutide, and sitagliptin groups were not statistically significant (all P>0.05). Only one patient died due to myocardial infarction in the placebo group, other patients with serious adverse reactions recovered after treatments.ConclusionsThe safety of exenatide treatment in patients with obesity or overweight was slightly inferior to insulin and sitagliptin, and better than taspoglutide. The safety of exenatide treatment for obesity or overweight was good.
  • 个案分析
    . 2012, 14(2): 101-4.
  • 病例报告
    ZENG Da-yong;WANG Chang-lian
    . 2013, 15(2): 95-2.
    A 38-year-old woman with left lower extremity vascular malformations received anterograde venography of deep vein of left lower limb. She was given an IV bolus of dexamethasone 10 mg, and followed by 0.9% sodium chloride injection 50 ml plus ioversol injection 50 ml at the rate of 0.3 ml per second. About 1 minute after IV bolus , the patient appeared pale, had cyanotic lips, chest stuffy, nausea, vomiting, blood pressure undetectable and no autonomous respiration. ECG showed ventricular fibrillation. She was given an IV bolus of dexamethasone and epinephrine immediately, and IV infusion of dopamine, isoprenaline, amiodarone, sodium bicarbonate, and atropine for several times. At the same time she was given closed cardiac massage,mouth-to-mouth resuscitation and electric defibrillation, and a temporary pacemaker was implanted. Two days later, the patient finally died despite resuscitation attempts of ventricular flutter.
  • 中药不良反应
    . 2007, 9(1): 57-58.
  • 中药不良反应
    Jia Min
    . 2009, 11(5): 376-2.
    Four female patients aged 29~40 years washed Buguzhi with bare hands under the sun outside. One day later, erythema with vesicle occurred in their hands, and the lesion site became slightly increased skin temperature and causalgia. The antiinflammatory, antiinfective and antiallergic treatments were given. Their erythema was subsided without cicatrix, but brown pigmentation remained.
  • 病例报告
    . 2002, 4(4): 262-262.
  • 病例报告
    . 2005, 7(1): 56-57.
    A 56-year-old man experienced fever and pharyngitis and was self-treated with amoxycillin capsule 0.5g. 4 hours later, he developed redness and blisters on skin, more serious on head, neck, chest, back and arms. It was considered that the skin rash was associated with amoxycillin. The agent was withdrawn immediately and treated with dexamethasone, antibiotics and calamine lotion. His conditions were deteriorated progressively including a temperature of 39.7℃, skin redness and edema spreading to legs. The herpes were increased and fused while some were broken and dropped. The patient was diagnosed as epidermolysis bullosa. The symptoms lessened and resolved gradually after receiving dexamethasone, antibacterials and supportive treatment.
  • 病例报告
    . 2001, 3(1): 9-9.
  • 安全用药
    . 2001, 3(2): 106-107.
  • 不良事件
    . 2005, 7(6): 465-465.
  • 中毒救治
    . 2003, 5(1): 30-32.
  • 病例报告
    . 2000, 2(3): 187-188.
  • WHO信息
    . 2001, 3(2): 128-128.
  • 病例报告
    . 2001, 3(3): 159-159.
  • 病例报告
    . 2005, 7(5): 372-373.
  • 病例报告
    . 2002, 4(3): 192-192.
  • WHO信息
    . 2004, 6(1): 63-63.
  • 不良事件
    . 2004, 6(6): 405-405.
  • 病例报告
    . 2004, 6(4): 250-250.
  • Wang Yueyuan, Zhou Yanglin, Yang Liu, Gou Mengqiu, Bian Yuan
    Adverse Drug Reactions Journal. 2021, 23(7): 348-351. https://doi.org/10.3760/cma.j.cn114015-20210624-00707
    Solid organ transplant (SOT) recipients are a high-risk population for coronavirus disease 2019 (COVID-19), and the safety and efficacy of COVID-19 vaccines in this population is of great concern. At present, the published studies on COVID-19 vaccines for SOT recipients are mainly about mRNA vaccines and there are a few cases reports on recombinant adenovirus vector-based vaccines. These results show that the COVID-19 vaccines are safe for the SOT recipients, but the immune response rates are lower and the incidence of vaccine breakthrough infections is higher than that in the general population. Based on the results of the current studies, SOT recipients can start to be vaccinated with COVID-19 vaccines 1 to 3 months after organ transplantation. Prevention of COVID-19 after vaccination is still necessary to avoid vaccine breakthrough infections.
  • 病例报告
    . 2004, 6(4): 260-260.
  • 病例报告
    . 2006, 8(6): 406-406.
  • 病例报告
    . 2006, 8(5): 382-383.
  • 病例报告
    . 2003, 5(2): 111-111.
  • 病例报告
    . 2006, 8(4): 251-251.
  • 病例报告
    . 2001, 3(2): 122-122.
  • 病例报告
    . 2006, 8(1): 52-53.
  • 中毒救治
    . 2005, 7(4): 276-277.
  • 病例报道
    . 1999, 1(1): 32-32.
  • 病例报告
    . 2004, 6(1): 45-46.
  • TANG Rui;ZHANG Hong-yu
    ObjectiveTo evaluate the efficacy and safety of danazol in treatment of hereditary angioedema (HAE).MethodsThe clinical data of patients with HAE in Department of Allergy, Peking Union Medical College Hospital during the period of 1985-2010 were collected and analyzed retrospectively. The patients were required to have received danazol over one year, the follow-up time was required to be longer than or equal to one year or the follow-up times were more than or equal to 5, and all the subjects should have complete follow-up data. The efficacy of danazol was evaluated according to the changes of frequency of hydroderma, abdominal pain and laryngeal edema, the changes of C1 and C4 inhibitor levels and the function of C1 inhibitor before and after treatment. The safety of danazol was evaluated according to the changes of liver function, body weight, and female′s menstruation before and after treatment.ResultsA total of 24 patients were enrolled in the study. They comprised 12 males and 12 females with an average age of (36±15) years and an average course of disease of (14.7±8.5) years. The initial dose of danazol was 200 mg twirce or thrice daily orally. One to 4 weeks later, the dosage was decreased to maintenance level gradually. The maintenance dose for male and female were (169±94) mg/d and (130±56) mg/d, respectively. The median time and the four quartile range of receiving danazol in 24 patients were 5 (1.1-10.3) years. The incidences of hydroderma, abdominal pain, and laryngeal edema before treatment were present in 100% (24 cases), 70.8% (17 cases), and 62.5% (15 cases), respectively. After the treatment, the variables mentioned above decreased to 41.6% (10 cases), 12.5% (3 cases), and 8.3% (2 cases), respectively. The differences were statistically significant (all P<0.01). One to 4 weeks after treatment, the level and function of C1 inhibitor in 24 patients increased from (0.08±0.06) g/L and (0.14±0.04) U/ml to (0.12±0.07) g/L (P=0.05) and (0.26±0.05) U/ml(P<0.001), respectively. But the level and function of C1 inhibitor did not returned to the normal yet. There were 22 patients whose C4 levels detection results were recorded. Of them, 17 patients presented to hospital before 2004 and 5 after 2004. Their levels of C4 were (23.5±12.6) mg/L, (56.9±30.0) mg/L and (0.06±0.01) g/L, (0.08±0.01) g/L before and after treatment, respectively. The differences were statistically significant (all P<0.05). Thirty and 45 days after treatment, two patients′ serum ALT levels increased from 25 and 20 U/L to 138 and 74 U/L, as well as developed alopecia, seborrhea, and dysthesia at the same time. The ALT levels in the two patients with abnormal liver function decreased to normal level after liver protective treatment. Six patients gained weight. Six females developed menelipsis or dysmenorrhea. The females′ symptoms of menstrual disorder were improved when the dosage of danazol was decreased to 200 mg/d daily or every other day.ConclusionsDanazol is effective and safe in treatment of HAE. It is suggested that C4 level may be an important monitoring indicator of danazol in HAE treatment.
  • 会议纪要
    . 2012, 14(5): 335-3.
  • 中药不良反应
    Jiao Lin
    . 2010, 12(4): 296-2.
    A 40yearold woman took Diaoliu pills 6 g thrice daily for her hyperplasia of mammary glands. After 5 days of the treatment, the patient developed the upper abdominal discomfort and nausea, followed by vomiting, fatigue and dark urine. Laboratory tests results: ALT 926 U/L,AST 452 U/L,TBil 68.9 μmol/L,DBil 36.5 μmol/L,IBil 32.4 μmol/L. Druginduced liver damage was diagnosed. Diaoliu pills were discontinued and liverprotective treatments were given. After 20 days of hospitalization her clinical symptoms disappeared and all laboratory indices returned to normal.
  • 病例报告
    Gao Lehong
    . 2011, 13(4): 255-2.

    A 16-year-old female patient with progressive myoclonic epilepsy developed non-convulsive status epilepticus after receiving oral phenytoin 0.15 g every 12 hours for one week. An EEG showed continuous spike-and-slow-wave complexes in all leads. Seven weeks after that, the patient was admitted to our hospital, her phenytoin dosage was reduced to 0.05 g twice daily at once and then withdrawn 2 days later. At the same time, the patient was given sodium valproate 0.3 g every 8 hours; clonazepam 1mg every 12 hours; levetiracetam 0.25 g every 12 hours. On day 3 of treatment, the patient’s myoclonic seizures disappeared. On day 6 of treatment, the EEG revealed sporadic spike-and-slow-wave complexes and slow waves. Twelve days after admission, the patient’s condition was stable, and she was discharged.

  • hen Yanfang, Feng Xia, Wang Ruolun
    . 2015, 17(4): 300.
    A 47-year-old man received an IV infusion of edaravone 30 mg twice daily for acute cerebral infarction. Three days later, the patient developed yellowish sclera. Laboratory examination showed the following levels: aspartate aminotransferase (AST) 269 U/L, alanine aminotransferase (ALT) 1 944 U/L, γ-glutamyl transpeptidase (γ-GT) 133 U/L, total bilirubin (TBil) 100.01 μmol/L, and platelet count 70×109/L. The patient was diagnosed as severe liver injury and thrombocytopenia due to edaravone injection. Edaravone was stopped and an IV infusion of polyene phosphatidylcholine 465 mg once daily was given. Seven days later, the patient′s yellowish sclera disappeared. Laboratory examination showed AST 44 U/L, ALT 187 U/L, γ-GT 148 U/L, TBil 25.4 μmol/L, and platelet count 121×109/L. Twelve days later, reexaminations showed AST 39 U/L, ALT 77 U/L, and γ-GT 126 U/L.
  • Liao Yin, Cheng Sheng, Luo Xiao, Wen Aiping, Zhang Yang, Shi Limin
    . 2015, 17(5): 325.
    ObjectiveTo evaluate the effectiveness and safety of immunosuppressive program including tacrolimus (FK506) in infants after liver transplantation.MethodsThe medical records of infants who underwent liver transplantation for biliary atresia and receiving the immunosuppressant of FK506 combined with methylprednisolone (MP) after operation in Beijing Friendship Hospital during June 2013 to September 2014 were collected. The infants′ general clinical situation, recipient survival rate, survival rate of transplanted liver, transplant complication, acute rejection rate, and adverse reactions were recorded. The whole blood trough concentration of KF506 on day 3, 7, 15 and one month after medication and occurrence of rejection and adverse reactions were recorded.ResultsA total of 54 infants were enrolled into this study, 50% were boys.  The children′s age was 4-19 months, the median age was 8 months. Seven infants died within 14 to 45 days after liver transplantation. Both recipient survival rate and survival rate of transplanted liver were 87%. Three cases (5.6%) developed transplant complication on days 7-9 after operation, among them 2 cases had hepatic artery thrombosis and 1 case had bile leakage, respectively. Ten infants (18.5%) developed acute rejection on days 4-14 after operation. The incidence of adverse reaction during hospitalization was 35.2% (19/54).  Twenty-five case-times adverse reactions involved 19 infants. There were 5 case-times of severe adverse reactions which involved 5 infants (3 cases died from epilepsia, increased creatinine, and heart failure, respectively; 2 cases recovered to normal from increased serum alanine aminotransferase after the treatment of liver protection). There were 20 case-times general adverse reactions (diarrhea, vomiting and skin rash etc.) which involved 17 infants. They all improved after symptomatic treatment. The mean blood concentration of FK506 on days 3, 7, 15 and one month after medication were (9.6±5.7), (8.7±4.5), (9.2±3.7) and (8.6±4.1) μg/L, respectively. The blood concentration of FK506 was 2.4-9.3 μg/L with an average concentration of (5.10±2.04)μg/L when acute rejection occurred and 6.2-23.9 μg/L with an average concentration of (11.67±3.58) μg/L when adverse reactions occurred. The average blood concentration of FK506 was(11.67±3.58)μg/L and the concentrations in 17 of 25 cases were over 10 μg/L. ConclusionFK506 at blood concentration 6.0-11.0 μg/L in infants used for immunosuppressive therapy after liver transplantation is relatively effective and safe.
  • 病例报告
    Tang Rui;Zhang Hongyu
    . 2014, 16(4): 250-2.
    A 17-year-old female who was diagnosed as typeⅠhereditary angioedema (HAE-Ⅰ) received an IV infusion of 6-aminocaproic acid 4 g once daily. Headache and nausea appeared about one hour after the IV infusion and developed severe bitemporal headache accompanied with weakness, mental fatigue and difficult to move. The symptoms were disappeared about one hour after the IV infusion finished. The above-mentioned symptoms were recurrent and ingravescent during the IV infusion of 6-aminocaproic acid from the second to the eighth days. The symptoms were disappeared about one hour after the IV infusion finished.
  • 病例报告
    Yang Siyun;Hu Xiaoyan;Ji Yifei;Su Qiang;Pan Zhaoping;Jiang Zhongcai
    . 2014, 16(6): 377-2.
    Patient 1, a 25-year-old female with ectopic pregnancy received an IV infusion of desmopressin acetate 15 μg every 12 hours due to tubal embryo surgery incision and pelvic adhesion separation surgery. On day 2, about 30 minutes after the start of infusion, the patient developed delirium, confusion, convulsion, and trismus. Laboratory tests showed that serum sodium was 125 mmol/L (preoperative serum sodium was 142 mmol/L). Hyponatremic encephalopathy induced by desmopressin acetate was considered. Desmopressin acetate was withdrawn immediately and she was given sodium supplement. About 10 minutes later, the patient′s symptoms relieved. She had consciousness and serum sodium level rose to 141 mmol/L on the next day. Patient 2, a 42-year-old female patient received an IV infusion of desmopressin acetate 18 μg every 12 hours after radical treatment of perianal abscess. On day 4, the patient developed dizziness, sweating, tremor of hands, chills, and oliguria. On day 5, the patient developed nausea, upward deviation of the eyes, and muscular rigidity and clonus in both upper limbs. Laboratory tests showed that serum sodium was 124 mmol/L (preoperative serum sodium was 141 mmol/L). Her CT examination showed extensive edema in white matter of the cerebral hemisphere. Hyponatremic encephalopathy induced by desmopressin acetate was considered. Desmopressin acetate was stopped and she was given symptomatic treatments such as sodium supplement. One day later, the patient′s symptoms disappeared and her serum sodium increased to 138 mmol/L.
  • Chen Weizhi
    A 65-year-old male patient received an IV infusion of ceftriaxone sodium 3.0 g/d for cough in local clinic. Sixteenth hours after the medication, he developed swelling and pain, ecchymosis and blister on skin of his forearms, haematoma at the venipuncture spot, and gross hematuria. No other drugs were applied at the same time. The results of laboratory test showed prothrombin time (PT)>100 s, activated partial thromboplastin time (APTT) >180 s, urine red blood cell(+++), urine occult blood(+++), urine white blood cell (+), and urine protein(++). The patient′s coagulation disorder was considered to be related to ceftriaxone sodium. IV infusion of vitamine K1, IV bolus of fresh frozen plasma, and local debridement were given. Fifteen days later, the patient′s skin ecchymosis alleviated and blisters disappeared. The results of laboratory test showed PT 14 s and APTT 30 s, and routine urine test was normal.
  • Sun Zhenxiao, Yu Xiangfen
    Adverse Drug Reactions Journal. 2021, 23(1): 51-52. https://doi.org/10.3760/cma.j.cn114015-20200624-00715
    A 61-year-old female patient with depressive disorder was prescribed paroxetine hydrochloride 20-mg orally once each morning, but the patient took the drug thrice daily by mistake. On the 6th day of medication, the patient suddenly fell down. She was unconscious accompanied by limb convulsion, presenting as epileptic attack. Electroencephalogram (EEG) showed a moderate abnormality. The patient had no previous history or family history of epilepsy, the cause of the seizures was considered to be overdose of paroxetine hydrochloride. The drug was taken correctly as prescribed by doctor and magnesium valproate sustained release tablets 0.25 g orally twice daily were added. The patient did not have any further epileptic attack and the EEG recovered to normal.
  • Yang Jing, Cui Xiangli, Yang Hui, Liu Lihong
    A 36-year-old male patient undergoing renal transplantation had postoperative fever and painful urination. Laboratory tests showed the white blood cell count (WBC) 17.1×109/L, neutrophils 0.92, hemoglobin (Hb) 113 g/L, and calcitonin (PCT) 3.04 μg/L. Urinary tract infection was considered and an IV infusion of cefoperazone sodium and sulbactam sodium 1.5 g every 8 hours was given. On day 4 of medication, painful urination was relieved and his body temperature returned to normal. Laboratory tests showed PCT 0.43 μg/L, WBC 8.5×109/L, neutrophils 0.90, and Hb 81 g/L. Anti-infective treatment was continued and subcutaneous injection of recombinant human erythropoietin injection (CHO cell) 4 000 IU every 48 hours was given. On day 7, laboratory tests showed his WBC 9.7×109/L, neutrophils 0.88, PCT 0.15 μg/L, and Hb 74 g/L. The reduction of hemoglobin was considered to be associated with cefoperazone sodium and sulbactam sodium. Cefoperazone sodium and sulbactam sodium was replace by sequential therapy of oral cefuroxime. On day 2 of drug replacement, his Hb was 80 g/L and recombinant human erythropoietin injection (CHO cell) was discontinued. On day 7, his Hb was 90 g/L and on day 12, 97 g/L.
  • 论著
    hang Shibin;Song Yanming;Feng Li;Zhao Yuan;Ding Huiguo
    . 2014, 16(3): 139-4.
    ObjectiveTo preliminarily evaluate efficacy and safety of endoscopic embolization with Glubran-2 glue for gastric varices in liver cirrhosis.MethodsForty-nine patients with cirrhosis gastric varices, admitted to Beijing You′an Hospital from January 2011 to December 2012, underwent endoscopic embolization with Glubran-2 glue under gastroscopy. Of the 49 cases, 40 were males and 9 females with age of 34-82 (55±11) years. Of these patients, 19 were at Child-Pugh class A, 23 class B, and 7 class C. Of the 49 patients, 22(44.9%) had isolated gastric varices (IGV) and 27 patients (55.1%) had gastro-esophaged varices (GOV). The methods were as follows: 50% glucose was prefilled in injection syringe and, after injecting Glubran-2 glue at the location of gastric varices, the left Glubran-2 glue in injection syringe was injected into the varicose vein via the 50% glucose. The Glubran-2 glue was given by way of one spot or multiple spot and each spot needed Glubran-2 glue 1.0-3.0 ml. The endoscopic embolization completed at one time as possible. The situation of varicose veins disappearing was observed under gastroscopy at months 1, 3, 6 after treatment. Safety evaluation index included postoperative burning sensation below the xiphoid, ectopic embolism, fever, blood routine test before operation and at 3 days after operation, and liver and renal functions before operation and at months 1, 3, 6 after operation.ResultsThe total dose of Glubran-2 glue for IGV patients was 2.0-12.0 ml every patient with an average dose of (4.7±2.6) ml and for GOV patients was 1.0-9.0 ml with an average dose of (4.2±2.1) ml. Of the 49 patient, varicose veins of 45 patients (91.8%) disappeared and varicose veins of 4 patients(8.2%) improved; extrusions of glue was seen in 18 patients (36.7%) at one month, 30 patients (61.3%) at 3 month, and 1 patient (2.0%) at 6 months after treatment. All the patients experienced burning sensation below the xiphoid after glue injection. Three patients presented with fever after operation but their temperature did not exceed 38 ℃. No patient developed ectopic embolism. Nine patients (18.4%) deve-loped errhysis due to local ulcer because of extrusions of glue and massive haemorrhage did not occur. There were no obvious differences in blood routine test and liver and renal functions before and after treatment.ConclusionEndoscopic embolization with Glubran-2 glue is effective and safe for treatment of gastric varices in liver cirrhosis patients.
  • 病例报告
    Zhang Yanmei;Song Yanqin;Ouyang Yanjun
    . 2011, 13(5): 322-2.

    A 48-year-old man developed liver cancer recurrence and received SC recombinant human interferon α2b. An initial dose was 1 million units thrice weekly for one month, and the dose was then increased to 2 million units thrice weekly. After 1 month of treatment, the patient developed cold intolerance, fatigue, muscle ache and pain in his loins and lower limbs, and his condition deteriorated. Thyroid function tests revealed the following levels: TSH 0.085 mU/L, FT3 2.20 pmol/L, FT4 3.52 pmol/L. Thyroid ultrasound showed bilateral reduced thyroid size, diffuse bilateral thyroid damage. Recombinant human interferon α2b was stopped and he was given levothroxine sodium 25 μg once daily. One month later, repeat thyroid function tests showed the following levels: TSH 0.053 mU/L, FT3 2.52 pmol/L, FT4 9.51 pmol/L.

  • 病例报告
    He Xiaobo;Wang Xiaoyan
    . 2011, 13(5): 310-2.

    A 84-year-old woman received simvastatin 40 mg thrice daily for coronary atherosclerotic cardiopathy. After ten years treatment, the patient developed generalised muscular pain and asthenia. On admission, physical examination showed increased muscle tone and marked tenderness. Laboratory examination revealed creatine kinase level was 4488U/L. Rhabdomyolysis was considered to be induced by simvastatin, so simvastatin was stopped and other drugs were continued, and coenzyme Q10 was administered. After 12 days, her creatine kinase level decreased to 85 U/L.

  • BAI Fan;LIU Yang;FENG Lei
    A 78-year-old man, who was newly diagnosed with epidermal growth factor receptor-positive lung cancer, received treatment with oral erlotinib 150 mg once daily. Laboratory test before the chemotherapy showed the following values: alanine aminotransferase (ALT) 12 U/L, aspartate aminotransferase (AST) 16 U/L, total bilirubin (TBil) 22.0 μmol/L, direct bilirubin (DBil) 7.6 μmol/L. Two weeks after chemotherapy treatment, re-examination revealed the following values: ALT 30 U/L, AST 33 U/L, TBil 20.0 μmol /L, DBil 6.3 μmol/L. Two months after chemotherapy, the patient presented with dark urine and yellowish whole skin and sclera. Seventy-five days after the chemotherapy, laboratory test showed the following values: ALT 368 U/L, TBil 182.1 μmol/L, DBil 155.2 μmol/L. Erlotinib was discontinued and liver-protective treatment was given. On day 4 after erlotinib discontinuation, the levels of ALT, AST, TBil, and DBil were 171 U/L, 177 U/L, 322.0 μmol/L, and 278.2 μmol/L, respectively. On day 6 after erlotinib discontinuation, methylprednisolone was added to his regimen. On day 12 after erlotinib discontinuation, the levels of ALT, AST, TBil, and DBil were 132 U/L, 141 U/L, 172.6 μmol/L, 135.4 μmol/L, respectively. Two months after erlotinib discontinuation, the levels of ALT, AST, TBil, and DBil were 12 U/L, 30 U/L, 19.8 μmol/L, and 13.5 μmol/L, respectively. Then chemotherapy was switched to 6 cycles of gemcitabine and nimotuzumab and abnormal liver function did not recur.
  • LIU Li-hui;HU Wen-qing;SHI Bing;YE Li-ping;ZHANG Yong-qing
    . 2013, 15(5): 284-2.
    A 52-year-old woman underwent the allogeneic hematopoietic stem cell transplantation because of severe aplastic anemia. She received cyclosporine to prevent graft versus host disease after operation. Two months later, the patient′s therapy was changed to tacrolimus 0.5-1.5 mg twice daily orally because of her renal inadequacy. The trough concentration of tacrolimus was 2.4-7.2 μg/L. The patient developed shortness of breath, fatigue and orthopnea subsequently. The result of echocardiography showed a hypertrophy of interventricular septum (13 mm) 50 days after administration of tacrolimus. Tacrolimus was withdrawn, and her therapy was changed to sirolimus and mycophenolate mofetil capsules. The patient′s symptoms improved gradually. Twenty days later, the echocardiogram showed the thickness of interven-tricular septum was 10 mm.
  • 安全信息
    . 2013, 15(1): 32-1.
  • 中毒救治
    . 2003, 5(6): 394-395.
  • 实验论著
    Tang Qing;Liu Shumin**;Wang Jiazhi;Zhou Qi;Liu Tianyu
    . 2010, 12(2): 91-5.

    Objective: To study the expression of grp78 and bad genes in rat livers after giving Dioscorea bulbifera rhizome alone and Dioscorea bulbifera rhizome plus Angelica sinensis root in order to explore the mechanism of Dioscorea bulbifera rhizome induced liver damage and actions of Angelica sinensis root on alleviation of liver damage induced by Dioscorea bulbifera rhizome. Methods:A total of 30 clean grade SD male rats were divided randomly into three groups: the Dioscorea bulbifera rhizome group, the Dioscorea bulbifera rhizome plus Angelica sinensis root group and the control group. Each group comprised 10 rats. The rats in the 3 groups mentioned above were respectively gavaged with 2 mL of the suspension of Dioscorea bulbifera rhizome extracts (1 mL of the suspension was equivalent to Dioscorea bulbifera rhizome 0.067g), 2 mL of the suspension of Dioscorea bulbifera rhizome extracts plus Angelica sinensis root extracts (1 mL of the suspension was equivalent to Dioscorea bulbifera rhizome 0.067 g and Angelica sinensis root 0.133 g), and 2 mL of 0.5% sodium carboxymethyl cellulose (CMC) solution twice daily for 14 days. The expression of grp78 and bad genes in rat livers were measured by quantitative realtime PCR (real time Q-PCR) 24 hours after the last administration. Results:After it was corrected by housekeeping gene gapdh, the expression of grp78 and bad genes in rat livers in the three groups were as follows: 2-△△Ct of grp78 and bad genes in the Dioscorea bulbifera rhizome group were 339.9 and 256.2, respectively; 17.0 and 9.9 in the Dioscorea bulbifera rhizome plus Angelica sinensis root group, respectively; 1.0 and 1.0 in the control group, respectively. The expression of grp78 and bad genes were upregulated in the Dioscorea bulbifera rhizome group compared with the control group. The difference was significant(P<0.01). The expression of grp78 and bad genes were downregulated in the Dioscorea bulbifera rhizome plus Angelica sinensis
    root group compared with the Dioscorea bulbifera rhizome group. The difference was significant(P<0.01). Conclusion:Dioscorea bulbifera rhizome can increase the expression of grp78 and bad genes in rat livers,which may be the mechanism of liver damage induced by Dioscorea bulbifera rhizome. Antagonistic actions of Angelica sinensis root on the expression of Dioscorea bulbifera rhizome-induced up-regulated grp78 and bad genes in rat livers is one of the possible mechanisms of alleviation of Dioscorea bulbifera rhizomeinduced liver damage.

  • 安全信息
    . 2007, 9(3): 225-225.
  • 安全信息
    . 2007, 9(3): 227-227.
  • 病例报告
    . 2003, 5(5): 332-333.
  • 调查研究
    Ye Xiaoqing;Huang Xiaodie;Wang Hui;Zhang Lili
    . 2005, 7(4): 250-252.
    Objective:To observe if aprotinin therapy is associated with increased risk of perioperative myocardial infarction in patients undergoing coronary artery bypass grafting(CABG). Methods: 11 patients scheduled for CABG received mild hypothermia cardiopulmonary bypass(CPB)and aprotinin 5 million kallikrein-inhibiting units. 6 cases were perfused with cold blood cardioplegic solution and others were perfused with HTK solution. Creatine kinase-MB(CK-MB) were detected and abnormal electrocardiogram and chest pain were recorded during and after operation. Results: CK-MB increased significantly during CPB and on the first day after operation and returned to normal on the second day after operation. All patients didn't complain of chest pain, and an ECG showed transient ST-segment elevation in 5 cases. One patient died of respiratory failure and others recovered . Conclusion: There is no proof that the use of large-dose aprotinin can increase the risk of perioperative myocardial infarction in …更多patients undergoing coronary artery bypass grafting.
  • 不良事件
    . 2004, 6(3): 188-188.
  • 专题讲座
    . 2006, 8(2): 127-129.
  • 监测简报
    . 2004, 6(2): 125-126.
  • 不良事件
    . 2002, 4(2): 141-141.
  • 药物滥用
    . 2006, 8(4): 286-287.
    滥用或长期使用阿片类物质可增加肝肾细胞脂质过氧化反应,引起肝肾细胞生物化学发生改变,血清丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、乳酸脱氢酶、尿素氮、肌酐和脂质过氧化反应产物丙二醛(MDA)水平显著升高;光学显微镜检查可观察到肝脏中心小叶充血、病灶坏死,肾脏管形细胞空泡化等组织病理学变化。
  • 安全信息
    . 2010, 12(1): 70-1.
  • 病例报告
    Liu Na;Hou Caiyan;Wu Ye;Li Jin
    . 2009, 11(2): 141-1.
    A 34yearold woman, who was a normal hematopoietic stem cell donor, received SC filgrastim 300 μg twice daily for mobilization of bone marrow stem cell. The next day, the donor experienced headache, lumbago, nausea, and vomiting. On day 3, her symptoms became aggravated, her vomiting was frequent (4 to 5 times daily) and led to eating difficulties. Routine blood tests revealed a WBC count of 66×109/L, a PLT count of 221×109/L, and a Hb level of 124 g/L. She gradually improved 4 days later.
  • 不良事件
    . 2004, 6(3): 150-150.
  • WHO信息
    . 2002, 4(3): 207-207.
  • 病例报告
    . 2006, 8(5): 373-374.
  • 不良事件
    . 2006, 8(3): 220-220.
  • 中药不良反应
    . 2006, 8(5): 391-392.
  • 病例报告
    . 2001, 3(3): 194-194.
  • 病例报告
    . 2000, 2(4): 256-257.
  • 安全用药
    . 2001, 3(2): 105-106.
  • Fan Kaiting, Qiao Yuchen, Wang Rui, Xie Bingxin
    Adverse Drug Reactions Journal. 2024, 26(12): 720-725. https://doi.org/10.3760/cma.j.cn114015-20240826-00006
    Objective To explore the occurrence and clinical characteristics of infusion-related reactions (IRRs) caused by lecanemab in Chinese patients with Alzheimer disease, and summarize the nursing management experience of IRRs. Methods This study was a single center retrospective study and the subjects were Alzheimer′s disease patients who received lecanemab (10 mg/kg, once every 2 weeks) in the Department of Neurology, Xuanwu Hospital, Capital Medical University from June 26 to August 18, 2024. The occurrence, clinical characteristics, severity, and outcome of IRRs that occurred during the treatment of lecanemab in these patients were descriptively analyzed. Results A total of 45 patients were included in the study, including 15 males (33.3%) and 30 females (66.7%); the age ranged from 52 to 82 years, with a median age of 62 years. Among the 45 patients, 15 (33.3%) developed IRRs, including 6 males and 9 females, and 2 of them had a previous history of allergy. In the 15 patients, there were 3, 8, 1 and 3 patients with 1, 2, 3 and 4 treatment cycles, respectively; 13 patients were pretreated with diphenhyd-ramine 30 minutes before lecanemab treatment; 14 patients had IRRs in the first cycle of lecanemab treatment, and 1 in the second cycle; IRRs occurred within 5 hours after finishing the intravenous infusion of lecanemab in 13 patients and on the second day after the administration in 2 patients. The main manifestations of IRRs were fever and chills; some patients had headache, nausea, and vomiting symptoms, and only 1 patient developed rash and itching. After symptomatic treatments, these symptoms in the 13 patients were relieved soon, and IRRs did not recur after the continued treatment of lecanemab according to the regime. The severity of IRRs was grade 1, 2, and 3 in 5, 9, and 1 patient, respectively. The incidence of severe IRRs was 2.2% (1/45). Conclusions IRRs are common adverse reactions of lecanemab, mainly characterized by fever and chills, with mild severity. Generally, lecanemab-related IRRs occurs after the first administration, and may not occur again in the continued treatments. Vital signs should be routinely monitored in lecanemab treatment. Once IRRs occur, timely treatments should be given according to the severity, and the prognosis is usually good.
  • Lin Caiyan, Ma Danfang, Chen Chongze, Wei Feng
    Adverse Drug Reactions Journal. 2022, 24(5): 271-273. https://doi.org/10.3760/cma.j.cn114015-20211011-01054
    A 47-year-old female patient with Helicobacter pylori (HP) infection received anti-HP regimen, including pantoprazole enteric coated tablets 40-mg orally twice daily, amoxicillin capsules 1 g orally twice daily, and furazolidone tablets 0.1 g orally thrice daily. The patient had previously taken amoxicillin capsules and pantoprazole enteric coated tablets several times without adverse reactions. On the 12th day after receiving anti-HP treatment, the patient developed fever, shortness of breath, body temperature of 38.3-℃, and conjunctival hemorrhage of the right eyeball. Laboratory tests showed that percentage of eosinophils was 0.08. Chest CT showed interstitial pulmonary edema in bilateral lungs and a small amount of effusion in the right pleural cavity. Acute lung injury associated with furazolidone was considered. Furazolidone was stopped. The patient received glucocorticoid and symptomatic treatments. Six days later, the patient′s symptoms such as fever and shortness of breath were relieved and the conjunctival hemorrhage in the right eye was absorbed; laboratory test showed that percentage of eosinophils was 0.008; the chest CT showed that the interstitial pulmonary edema in bilateral lungs was more absorbed than before and the pleural effusion on the right side was basically absorbed.
  • 不良事件
    . 2002, 4(1): 53-53.
  • 病例报告
    . 2004, 6(4): 253-253.
    A 72-year-old man was hospitalized with pathological changes of both hip joints. Day 6 after op-eration of hip joint replacement, the patient was treated with intravenous infusion of fleabane. He devel-oped headache, palpitation and dyspnea during the infusion, then the agent was discontinued immediately. Oxygen was administrated. ECG showed sinus arrhythmia and frequent atrial premature beats of 4-5/min. It was considered in association with fleabane. 30 minutes later, the symptoms including headache and palpitation lessened, respiration was stable and ECG showed normality. Headache and palpitation resolved 1 hour later.
  • 病例报告
    . 2004, 6(4): 259-260.
  • 不良事件
    . 2006, 8(3): 225-225.
  • 病例报告
    Wu Rongrong;Chen Hongge;Wei Zhenman;Han Jin
    . 2008, 10(5): 0-0.

    A 64-year-old woman with breast cancer developed jaundice and abnormal liver function after chemotherapy. A liver CT scanning was performed to determine whether there were liver metastases after admission. The woman suddenly developed dizziness, chest distress, and dyspnea after administration of IV iopamidol 30 mg. Subsequently, unconsciousness and generalized convulsion occurred. Her blood pressure was unrecordable. The patient was diagnosed with iopamidolinduced anaphylactic shock. Her symptoms recovered gradually following antianaphylactic and antishock treatment.

  • 病例报告
    . 2006, 8(4): 302-302.
  • 安全用药
    . 2002, 4(5): 304-305.
  • 病例报告
    . 2001, 3(2): 109-109.
  • 病例报告
    . 2001, 3(4): 273-273.
  • 病例报告
    . 2006, 8(2): 136-136.
  • 病例报告
    . 2003, 5(1): 44-45.
  • WHO信息
    . 2003, 5(5): 353-353.
  • 监测简报
    . 2004, 6(3): 193-194.
  • 病例报告
    . 2004, 6(3): 194-194.
  • ADR监测与防治
    . 2000, 2(3): 174-174.
  • 药物评介
    . 2000, 2(2): 135-136.
  • 病例报道
    . 1999, 1(1): 51-51.
  • 病例报告
    . 2002, 4(4): 257-257.
  • 病例报告
    YAO Hong-ping
    . 2013, 15(1): 38-2.
    A 50-year-old female patient received oral methimazole 25 mg twice daily for hyper-thyroidism. About 5 months later, she developed fatigue, yellow urine. Her symptoms progressed to severe jaundiced skin and sclera after 10 days. Laboratory tests revealed the following levels: alanine aminotransferase 54 U/L, aspartate transaminase 105 U/L, total bilirubin 628.6 μmol/L, direct bilirubin 542.7 μmol/L, total cholesterol 1.7 mmol/L, total protein 60 g/L, albumin 33 g/L, alkaline phosphatase 130 U/L, total bile acid 145.2 μmol/L, γ-glutamyl transferase 83.1 U/L. Methimazole was stopped, her regimen was changed to oral prednisone 10 mg four times a day and oral propranolol 10 mg thrice daily. At the same time, liver-protective drugs, and the drugs used for the treatment of jaundice were given. About 1 month later, the patient suddenly developed palpitation, agitation, irrelevant speech, and slow response. Labor-tory tests showed that the blood ammonia level was 25 μmol/L, grade Ⅰhepatic encephalopathy was diagnosed. And then she was treated with liver-protective drugs, and the drugs used for the treatment of jaundice and hepatic encephalopathy. One week later, her hepatic encephalopathy symptoms improved, and her jaundice was relieved three weeks late.
  • JIN Meng-ya;WU Jia-rui;DONG Ling;ZHANG Xiao-meng
    . 2013, 15(5): 277-3.
    The toxic traditional Chinese medicine (TCM) is the drugs that may damage the body′s tissues and organs, disrupt or destroy the normal physiological function, lead to pathologic changes, and even threaten life when the drugs are improperly used. Totally 83 kinds of toxic TCM, including 10 kinds of extremely toxic, 42 kinds of toxic, and 31 kinds of slightly toxic TCM as described in the Chinese Pharmacopoeia (2010). Currently, progresses have been made in the studies on bioactive components, toxicokinetics, and metabonomics of the toxic TCM in our country. But some problems still exist, such as relatively small species members of TCM were entered in the safety evaluation research, limited study methods, and the non-standard management. The effective ways to promote rational use of toxic TCM include some measures such as learning the safety evaluation methods in other counties and formulating the strict quality standards.
  • 中毒救治
    SONG Yu-guo;DU Xu-qin
    . 2012, 14(6): 369-4.

    Paraquat can do human body harm by digestive tract, skin and mucosa, and some other routes. Clinical manifestations of acute paraquat poisoning include single or multiple organs damage of skin and mucosa, lung, liver, kidney, and so on. Patients may develop asymptom or mild local irritant symptoms and, after a latent period of several hours to several days, the conditions may become aggravated suddenly. At present, no specific effective method can be used for treating acute paraquat poisoning and the long latency is an important “time window” for clinical management. There is still ongoing controversy surrounding the effect of blood purification for acute paraquat poisoning; nevertheless, part of patients may be saved by early and repeated blood purification. Blood concentration of paraquat is closely related to clinical manifestation and prognosis of poisoning and the higher concentration can cause the greater harm to human body and the higher fatality.

  • 学术动态
    . 2011, 13(4): 266-1.
  • 中毒救治
    Deng Zhen;Xiang Yunjie;Shen Qing
    . 2011, 13(1): 38-2.
    An 8monthold male infant suffered from pneumonia and treatment with salbutamol sulfate 0.8 mg (1/3 tablet) thrice daily was planned. However, because of his parents’misunderstanding, the infant was given a single dose of salbutamol sulfate 7.2 mg (3 tablets). One hour later, the infant presented with nausea, vomiting, and diarrhea with 6 watery stools. A routine stool examination showed watery stool with fat globules (++). Salbutamol sulfate was withdrawn. Cefoperazone sodium/sulbactam sodium, asarone, and sodium bicarbonate were given; in addition, he received an enema and antidiarrheal treatment. As a result, his condition was brought under control.
    KEY WORDSsalbutamol sulfate; diarrhea
  • 综述
    Gao Ruya;Zhu Kongcai;Hu Xin;Cao Guoying
    . 2014, 16(5): 297-3.
    Polymyxin E and polymyxin B were the polypeptide antibiotic which were obtained from the Bacillus polymyxa medium. They were used to treat the resistant bacterial infection with Pseudomonas aeruginosa, Acinetobacter baumannii and Klebsiella pneumonia. The adverse reactions of polymyxin E were renal toxicity and nervous system toxicity. Age, dose and the combination with other drugs are the risk factors of renal toxicity. Combination with antioxidant, free radical scavenger and some Chinese medicine with protective effect on the kidney may reduce the renal toxicity of polymyxin E and improve the curative effect. Patients with renal insufficiency do not need to adjust the dose when they used polymyxin E and polymyxin B. Novel derivatives of polymyxin had lower renal toxicity.
  • Wang Lijun, Sun Na, Liu Hui, Li Xiaoqing, Zhan Hanqiu
    . 2017, 19(3): 178.
    ObjectiveTo analyze the efficacy and safety of oseltamivir in children with influenza H1N1.MethodsThe medical records of patients who were hospitalized and treated with oseltamivir in Beijing Ditan Hospital, Capital Medical University from Mar. 2009 to Mar. 2016 were analyzed retrospectively. They were divided into two groups according to the age: children group (≤14 years) and adults group (18-60 years). The duration of fever, length of stay, efficacy and adverse drug reactions were analyzed.ResultsA total of 349 patients were enrolled into the analysis. There were 159 cases in the children group which comprised 87 male and 72 female, aged from 10 months to 14 years with average age of (7±4) years, including 18 severe cases (11.3%). There were 190 cases in the adults group which comprised 117 male and 73 female, aged from 18 to 60 years with average age of (32±12) years, including 19 severe cases (10.0%). The differences in duration of fever and the length of stay between mild patients of the two groups were not statistically significant (P>0.05). The duration of fever and the length of stay were shorter in severe patients of children group than in severe patients of adults group [(2.3±1.3)d vs. (5.2±5.3)d, (6.8±4.4)d vs. (12.7±8.1)d, both P<0.05]. The rate of efficacy of the children group and the adults group were 100.0% (159/159) and 99.5% (189/190). There was no significant difference between the two groups (χ2=0.839, P>0.05). There was no significant difference in incidence of adverse events between the two groups [5.0% (8/159) vs. 3.7% (7/190), χ2=0.382, P>0.05].ConclusionOseltamivir is effective in the children with influenza H1N1 and it is safe with a low incidence of adverse reactions.
  • Zhao Hong, Hui Wuhan, Ji Bingxin, Hu Ronghua, Sun Wanling, Wan Suigui, Su Li
    . 2016, 18(1): 31.
    ObjectiveTo evaluate the effectiveness and safety of subcutaneous injection of bortezomib in patients with polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes (POEMS) syndrome.MethodsSince January 2013, patients who  were newly diagnosed with POEMS syndrome in hematology department of Xuanwu Hospital of Capital Medical University were given treatments with subcutaneous injection of bortezomib 1.3 mg/(m2·d) on day 1, 4, 8, 11 and dexamethasone 20 mg/d on day 1, 2, 4, 5, 8, 9, 11, 12 for a period of 28 days. The treatments included no more than 4 cycles. The effects and adverse reactions/events of the treatments were observed.ResultsUntil April 2015, 6 patients with POEMS syndrome were admitted. These patients aged from 37 to 66 years included 1 male, 5 female. All patients first presented with polyneuropathy, accompanied by monoclonal gammopathy, organomegaly, edema, endocrinopathy and pigment in skins. Optic disc edema was found in 4 patients and 3 patients had bone lesions. After 2 to 4 cycles of treatments, peripheral neuropathy was improved in 5 patients. Monoclonal gammopathy disappeared in 5 patients. Organomegaly, edema, endocrinopathy and skin changes recovered to different degree in all 6 patients. Recovery of optic disc edema was found in all 4 patients. Adverse reactions/events happened in 6 patients during the therapy. Peripheral neuropathy of 1 and 2 grade were reported in 3 patients. Three patients developed 1 and 2 grade of gastrointestinal reactions during treatments. Three patients developed respiratory tract infection. One patient developed mild anemia. One patient developed abnormal liver function. No patient discontinued therapy because of adverse events.ConclusionSubcutaneous injection of bortezomib may be an effective and safe treatment for POEMS syndrome.
  • Li Ting, Feng Yufei, Ni Qian, Zhou Deping
    ObjectiveTo systematically evaluate the efficacy and bleeding risk of new oral anticoagulants (NOAC) in treatment for acute venous thromboembolism (VTE).MethodsRandomized controlled trials (RCT) about NOAC treatment for VTE in related databases collected up to December 2017 were searched. The literature in accordance with the inclusion criteria were selected and evaluated. The outcome measures included recurrence rate of VTE, all-cause mortality, incidence of hemorrhea or incidence of clinically relevant non-major (CRNM) bleeding. The results of RCT in accordance with inclusion criteria were combined using network meta-analysis. The effect measures were expressed in odds ratio (OR) with its corresponding 95% confidence interval (CI). ResultsA total of 9 RCT comprising 27 827 patients and 5 anticoagulant drugs (rivaroxaban, apixaban, edoxaban, dabigatran, and warfarin) were enrolled in the study. The quality evaluation showed that 4 of 9 RCT′s bias risks were low, 2 were uncertain, and 3 were high. Network meta-analysis results showed that neither the differences of recurrence rate of symptomatic VTE nor that of all-cause mortality among the patients with acute VTE using 5 different anticoagulant drugs were statistically significant. The results of surface under the cumulative ranking probability (SUCRA) showed that apixaban had the highest probability of having the optimal curative effect in decreasing symptomatic recurrence rate and all-cause mortality (SUCRA: 69.0%, 77.1%), followed by rivaroxaban (SUCRA: 60.7%, 51.4%). About the safety of the drugs, the risk of hemorrhoea induced by apixaban was lower than that induced by dabigatran and edoxaban (dabigatran vs. apixaban, OR=2.36, 95%CI: 1.16-4.83; edoxaban vs. apixaban, OR=2.64, 95%CI: 1.36-5.13). The risk of CRNM bleeding associated with apixaban was lower than that associated with rivaroxaban and edoxaban (edoxaban vs. apixaban, OR=1.67, 95%CI: 1.26-2.20; rivaroxaban vs. apixaban, OR=2.09, 95%CI: 1.59-2.74). The risk of CRNM bleeding associated with dabigatran was lower than that due to edoxaban and rivaroxaban (edoxaban vs. dabigatran, OR=1.36, 95%CI: 1.01-1.84; rivaroxaban vs. dabigatran, OR=1.71, 95%CI: 1.27-2.30). The results of SUCRA showed that the probability of hemorrhoea induced by apixaban was the lowest (SUCRA: 98.2%), followed by rivaroxaban, dabigatran, edoxaban, and warfarin; the probability of CRNM bleeding induced by apixaban was the lowest (97.0%), then followed by dabigatran, edoxaban, rivaroxaban, and warfarin.ConclusionsFor adult patients with new-onset or relapsed acute VTE, the efficacy of NOAC and warfarin were similar. The risk of bleeding with NOAC treatment was significantly lower than that with warfarin, of which, apixaban had the highest probability of having the best efficacy and the lowest risk of bleeding.
  • Mao Yimin
    Adverse Drug Reactions Journal. 2020, 22(2): 58-61. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.002
    Drug-induced liver injury (DILI) is the main reason for the failure of new drug research and development before marketing, warning increase post?marketing and withdrawal from the market, which is an important part of drug safety monitoring. It is very important for scientific supervision and clinical practice to pay attention to the liver safety of drugs and carry out corresponding transformation research. The premise of scientific supervision for DILI is to have a comprehensive understanding for its mechanism, risk factors, clinical diagnosis and evaluation, prediction for prognosis, effective interventions and overall assessment for risk/benefit. The mechanism of DILI is related to many links such as drug metabolism, hepatocyte death mechanism, signal transduction pathway, mitochondrial function damage, immune damage, genetic and environmental factors, and etc. For some drugs, combined detection of protein tyrosine phosphatase non-receptor type 22 and human leukocyte antigen is expected to be an important method to screen the high?risk population of DILI. Due to the lack of specific diagnostic markers, the diagnosis of DILI is facing challenges. The complex clinical phenotype of DILI also makes diagnosis more difficult. European and American countries have set up a special cooperative network of DILI, in which DILI patients were prospectively entered for follow?up and biological sample database were established, effectively promoting the research progress in DILI field. The Hepatox network platform (www.hepatox.org) established specially for DILI in China has been launched and more than 30?000 real world databases on DILI patients have been established, which lays a good foundation for subsequent transformation research.
  • Guo Yin, Li Yongtao
    . 2016, 18(3): 218.
    Two patients (patient 1, 78-year-old female; patient 2, 39-year-old male) received hemocoagulase for injection 4 KU once daily due to bleeding of left lower abdominal mass and traumatic shock, respectively. After 8 or 4 days of hemocoagulase treatments, fibrinogen levels in the 2 patients decreased (1.49 g/L decreased to 0.71 g/L in the patient 1; 2.01 g/L decreased to 0.52 g/L in the patient 2) and active bleeding appeared. It was considered that hypofibrinogenemia was caused by hemocoagulase for injection. Hemocoagulase for injection was stopped and blood plasma cryoprecipitate were given in the 2 patients. Five days later, the fibrinogen level in patient 1 was 2.01 g/L and abdominal ultrasonography showed no active bleeding in the left lower abdomen; the fibrinogen level of patient 2 was 3.44 g/L and the liquid from thoracic drainage tube turned to light red.
  • Zhang Junqiang, Xu Fei, Xu Xiaoling, Zhou Qianqian
    . 2017, 19(5): 377.
    A 60-years-old male patient with epidermal growth factor receptor gene exon 19 deletion mutant small cell lung cancer (T4N3M1b, exensive disease) received tyrosine kinase inhibitor erlotinib 150 mg orally once daily. On day 28 of medication, the patient felt aggravated chest distress. The result of reexamination of chest CT showed interstitial changes in lungs. He was diagnosed as interstitial lung disease due to erlotinib. Erlotinib was stopped. The patient received methylprednisolone for anti-inflammatory and symptomatic treatment. However, his symptoms were not relieved and the tumor progressed. The patient died on day 33 of erlotinib withdrawal.
  • 病例报告
    Zhao Mingxing;Chu Ruixue;Shi Xiaoping;Zhao Kaiming;Zhang Hua
    . 2010, 12(4): 293-2.
    A 58yearold man with primary hypertension received felodipine sustainedrelease tablets 5 mg once daily, atorvastatin calcium 10 mg once daily, and vitamin E 0.1 g once daily. Three months later, his blood biochemical tests showed a serum potassium level of 3.11 mmol/L. The patient was given potassium chloride sustainedrelease tablets, and his serum potassium level returned to normal. However, the potassium level decreased again after drug discontinuation, and then he was hospitalized. On admission, his serum potassium level was 3.35 mmol/L. Hypokalemia due to primary aldosteronism was excluded. Felodipine sustainedrelease tablets were withdrawn and switched to irbesartan 0.15 g once daily. Potassium chloride sustainedrelease tablets 0.5 g thrice daily was added to the regimen, and other treatments continued. Two weeks later, his blood biochemical tests revealed a serum potassium level of 4.19 mmol/L. Potassium chloride sustainedrelease tablets were stopped and, one month later, his serum potassium level was 3.85 mmol/L. Subsequently, his serum potassium level was normal on reexaminations.
  • 病例报告
    He Jiebaoa;He Jingchengb;Zhang Biqingc;Lu Xiaohuib;Luo Peib
    . 2011, 13(4): 262-2.

    A 45-year-old male patient himself took devilpepper root decoction(250 ml equivalent to 25 g) thrice daily for sore throat. On day 4 of treatment start, he developed yellowish urine, On day 7, he developed nausea, vomiting, asthenia, anorexia, yellowish skin and sclera. On day 9, he was hospitalized. Laboratory tests showed the following values: ALT 1735 U/L, AST 682 U/L. He was diagnosed with drug-induced hepatitis. Devilpepper root was discontinued immediately and he was given oral Yinzhihuang granule, followed by infusions of glutathione, matrine and diammonium glycyrrhizinate. On hospital day 12, repeat liver function tests revealed the following levels: ALT 97 U/L, AST 32 U/L. He recovered well and was discharged.

  • 安全信息
    . 2011, 13(4): 268-2.
  • ZHU Rong-fei;LIU Guang-hui;HUA Qing-quan;MA Jian;DONG Pin;TAN Guo-lin;FENG Yong
    . 2013, 15(5): 263-6.
    ObjectiveTo evaluate the efficacy and safety of beclometasone dipropionate aqueous nasal spray in the treatment of allergic rhinitis.MethodsThis is a multicenter, randomized, double-blind, and positive drug parallel controlled clinical trial. The patients with allergic rhinitis and who met the eligibility criteria were enrolled and divided into the test group and the control group. The patients in the test group received beclometasone dipropionate aqueous nasal spray and the patients in the control group received beclometasone dipropionate nasal spray. All patients in the 2 groups were administered two inhalations of beclomethasone dipropionate into each nostril twice daily (each inhalation contains beclometasone dipropionate 50 μg) for 14 days. The efficacy of these two drugs was evaluated according to the total scores of symptoms of rhinitis, scores of signs and quality of life and percentage changes of patients in three scores mentioned above when the treatment was over. The safety of these two drugs was evaluated according to the incidence of adverse events/adverse reactions, the results of laboratory tests, and ECG when the treatment was over.ResultsA total of 239 patients were included into the efficacy analysis. Of them, 120 patients were in the test group and 119 were in the control group. There was no significant differences in gender, age, rhinitis symptoms, and signs before the drug administration between the 2 groups (P>0.05). The total scores of symptoms of rhinitis, scores of signs and quality of life on days 7 and 14 of treatment decreased significantly as compared with those obtained before the treatment in the both groups (P<0.05), but there was no significant difference in the extent of decrease between the 2 groups (P>0.05). When the treatments were over, the differences in the percentage changes of patients of rhinitis symptoms, signs and quality of life scores before and after treatments in the both 2 groups were statistically significant (P<0.05), but there was no significant difference between the 2 groups (P>0.05). A total of 241 patients were included into the safety analysis. Of them, 121 patients were in the test group and 120 were in the control group. There were 12 adverse events in 10 patients in the test group. Of them, 2 events in the 2 patients were adverse drug reactions, including 1 case with throat discomfort and another case with nose bleeding. There were 20 adverse events in the 13 patients in the control group. Of them, 11 events in 7 patients were adverse drug reactions and nose bleeding and dry nose were their major manifestations. There was no significant difference in the incidence of adverse events between the 2 groups (P>0.05). No severe adverse events occurred during the clinical trial.ConclusionBeclometasone dipropionate aqueous nasal spray could effectively control the symptoms of allergic rhinitis and its efficacy and safety were similar to those of beclometasone dipropionate nasal spray.
  • 病例报告
    . 2005, 7(1): 47-47.
  • 病例报告
    . 2002, 4(6): 408-408.
  • 病例报告
    . 2004, 6(3): 178-178.
    Summary A 63-year-old man was admitted to hospital due to upper abdominal pain with nausea and vomiting for 12 hours, and diagnosed as acute severe pancreatitis. The patient was treated with fasting and sustained gastrointestinal decompression and with subcutaneously octreotide 0.1mg every 8 hours. His BP was elevated to 210/120mmHg.The man was managed with nifedipine,nitroglycerin and sodium nitroprusside without good results. Then octreotide was discontinued, and BP was gradually returned to normal.
  • 病例报告
    . 2005, 7(3): 212-213.
  • WHO信息
    . 2003, 5(3): 208-208.
  • 国外文献题录
    . 2003, 5(1): 59-60.
  • 网络医药
    . 2003, 5(1): 39-41.
  • 病例报告
    . 2006, 8(1): 73-73.
  • 病例报告
    . 2006, 8(1): 27-27.
  • 病例报告
    . 2001, 3(4): 263-263.
  • ADE简报
    . 2001, 3(2): 126-126.
  • 不良事件
    . 2002, 4(3): 175-175.
  • 网络医药
    . 2002, 4(5): 330-332.
  • 药物安全动态
    . 2006, 8(3): 231-231.
  • 病例报道
    . 1999, 1(2): 124-124.
  • 病例报告
    . 2004, 6(5): 338-339.
  • 病例报告
    . 2006, 8(5): 383-383.
  • 病例报告
    . 2004, 6(2): 91-91.
  • ADR咨询
    . 1999, 1(1): 13-13.
  • 病例报告
    . 2003, 5(4): 263-264.
  • 病例报告
    . 2003, 5(4): 258-258.
  • 病例报告
    . 2004, 6(5): 334-335.
  • ADR监测
    . 2004, 6(4): 265-266.
  • Zhang Yueyi, Ye Wenling, Li Mingxi, Ye Wei, Wen Yubing, Zheng Ke, Li Xuemei, Ai Sanxi
    Adverse Drug Reactions Journal. 2021, 23(9): 497-499. https://doi.org/10.3760/cma.j.cn114015-20201229-01296
    A 64-year-old female patient received postoperative adjuvant chemotherapy with oxaliplatin and capecitabine after radical resection of rectal cancer for rectal adenocarcinoma with multiple lung metastases. Due to poor therapeutic effect, the patient was switched to anlotinib treatment at a dose of 12-mg/d orally for 2 weeks with a 1-week break and 3 weeks was one cycle. During the second cycle of anlotinib treatment, the patient developed edema, proteinuria, hypertension, and hypoalbuminemia, with normal serum creatinine. The renal pathology suggested renal thrombotic microangiopathy, which was in line with the clinical and pathological manifestations of drug-related renal injury due to anti-vascular endothelial growth factor. After discontinuation of anlotinib and receiving symptomatic treatment such as blood pressure control, the edema gradually subsided along with remission of proteinuria. Three months later, the patient had no proteinuria and the serum albumin was normal.
  • Cai Junying, Chen Wanwen, He Yuwen
    Adverse Drug Reactions Journal. 2023, 25(4): 204-210. https://doi.org/10.3760/cma.j.cn114015-20221107-01035
    Objective To explore the influencing factors of immune checkpoint inhibitor-related pneumonitis (CIP) in lung cancer patients caused by programmed cell death 1 receptor (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitors. Methods A retrospective analysis was conducted on clinical data of lung cancer patients treated with PD-1/PD-L1 inhibitors in the First Affiliated Hospital of Guangzhou Medical University from January 2018 to June 2022. Patients with CIP were included in the CIP group, and those who did not experience any immune-related adverse events during the same period were screened in a 1∶1 ratio and included in the control group. The clinical characteristics in patients of the 2 groups were compared and influencing factors of CIP were analyzed using binary logistic regression method. The effect sizes were the odds ratio (OR) and its 95% confidence interval (CI). Results A total of 246 patients (123 in the CIP group and 123 in the control group) were entered in the analysis, including 208 males and 38 females, aged (63±9) years with a range of 32 to 86 years. The diagnosis was non-small-cell lung cancer in 234 patients and small cell lung cancer in 12 patients. There were no statistically significant differences in age, gender, history of respiratory diseases, tumor histological types, TNM stages, and types of immune checkpoint inhibitors used in patients between the 2 groups (all P>0.05). Compared with the control group, patients in the CIP group had a lower body mass index [(21.5±3.2) kg/m2 vs. (22.6±3.0) kg/m2, P=0.004], higher proportion of patients with Eastern Cooperative Oncology Group Performance Scale (ECOG-PS) ≥2 points[39.0% (48/123) vs. 22.0% (27/123), P=0.004], higher proportion of patients with a history of radiation therapy [25.2% (31/123) vs. 13.8% (17/123), P=0.024], and lower proportion of patients with combination therapy with chemotherapy/targeted drugs[82.9%(102/123) vs. 97.6%(120/123), P<0.001]. Before immunotherapy, the peripheral blood interleukin-1β and interferon-α were lower [1.97 (1.04, 2.74) ng/L vs. 2.40 (1.75, 4.03) ng/L, P=0.021; 2.08 (0.89, 3.00) ng/L vs. 2.76 (1.97, 3.94) ng/L, P=0.012], lymphocyte count was lower [1.4(1.0, 1.8)×109/L vs. 1.5(1.2, 2.1)×109/L, P=0.030], and the neutrophil-to-lymphocyte ratio was higher [3.85 (2.50, 6.40) vs. 3.11 (2.25, 4.61), P=0.006] in patients of the CIP group than those in the control group. The binary logistic regression analysis showed that baseline ECOG-PS ≥2 points (OR=3.400, 95%CI: 1.180-9.798, P=0.023) and combination of PD-1/PD-L1 inhibitors and chemotherapy/targeted therapy (OR=0.047, 95%CI: 0.005-0.454, P=0.008) were independent influencing factors for the occurrence of CIP. Conclusion The ECOG-PS ≥ 2 points before immunotherapy is an influencing factor for CIP, and the combination with chemotherapy/targeted therapy may reduce the risk of developing CIP in patients treated with PD-1/PD-L1 inhibitors.
  • Wang Yazhi, Duan Fangfang, Li Yue, Yang Song
    Adverse Drug Reactions Journal. 2024, 26(1): 50-52. https://doi.org/10.3760/cma.j.cn114015-20230911-00669
    A 63-year-old female patient with esophageal cancer received tislelizumab mono- therapy (intravenous infusion of 200-mg once every 21 days) after surgery. The patient had no disease history of chronic liver disease or diabetes mellitus. At day 39 after the fourth cycle of tislelizumab treatment, abnormal liver function was found, with alanine aminotransferase 494-U/L, aspartate aminotransferase 442-U/L, alkaline phosphatase 1-161-U/L, and total bilirubin 21.4-μmol/L. Then no further tislelizumab was given. After excluding liver injury caused by other reasons through liver pathological examination and relevant laboratory tests, it was considered to be related to tislelizumab. After giving methylprednisolone (32-mg/d orally) and liver protective treatments, the patient′s liver function was gradually improved. After 2 weeks of treatment, the dose of methylprednisolone was reduced to 16-mg/d, and 2 weeks later, the patient′s fasting blood glucose rose to 19.4-mmol/L. The dose of methylprednisolone was reduced to 8-mg/d. After 2 days, the blood glucose rose to 33.7-mmol/L, blood lactate 3.66-mmol/L, and urinary ketone (++++). Diabetic ketoacidosis was diagnosed and methylprednisolone was discontinued. The fasting and 2-hour postprandial serum insulin and C-peptide levels were significantly reduced, suggesting the damage of pancreatic islet function. Type 1 diabetes caused by tislelizumab was considered. After treatments such as insulin supplement and correcting acidosis, the patient's liver function was improved. At 8 months of follow-up, the patient′s liver function returned to normal, but long-term insulin supplement was needed to control blood glucose.
  • Wang Lijian, Fan Ruoxi, Zhu Xu, Guan Yu, Li Lei
    Adverse Drug Reactions Journal. 2024, 26(3): 145-149. https://doi.org/10.3760/cma.j.cn114015-20231204-00864
    Objective To analyze the general rules and characteristics of adverse reactions of succinylated gelatin injection and provide reference for safe and rational clinical use. Methods Adverse reaction reports related to succinylated gelatin injection in National Adverse Drug Reaction Monitoring System database from January 2004 to August 2021 were collected. Retrospective analysis of patients′ gender, age, primary disease, reason for drug use, combined drugs, and time of adverse reaction occurrence from drug use, clinical manifestations, severity and patient outcomes were performed, and classified statistics were performed according to systematic organ class (SOC) and preferred terms of Medical Dictionary for Regulatory Activities. Results A total of 3-036 adverse reaction reports of succinylated gelatin injection were entered, including 710-serious cases (23.39%), and the top 5 SOCs involved diseases of the immune system, systemic diseases and various reactions at the administration site, skin and subcutaneous tissue diseases, vascular and lymphatic diseases, and respiratory/thoracic and mediastinal diseases. The main symptoms were anaphylactic shock, similar rapid severe allergic reaction, chills, fever, and other rapid severe allergic reactions. Among the 3-036 patients, 1-543 were cured, 1-480 were improved, 3 were not improved, 2 had sequelae, 2 died, and 6 had unknown results. The SOCs involved in adverse reactions and not recorded in labels included ocular organ diseases, various musculoskeletal and connective tissue diseases, metabolic and nutritional diseases, kidney and urinary system diseases, etc. Conclusions The adverse reactions related to succinylated gelatin injection are mostly associated with anaphylaxis. Severe adverse reactions are consistent with the characteristics of rapid severe anaphylaxis, but there may be related risks not covered in labels.
  • Li Chao, Chen Ya, Peng Guiqin, Bai Hao, Lai Xiangyu, Chen Wanyi
    Adverse Drug Reactions Journal. 2022, 24(5): 273-273. https://doi.org/10.3760/cma.j.cn114015-20210925-01017
    A 56-year-old male patient with lymphoma received anti-tumor treatments with treprizumab (intravenous infusion of 240-mg once every 21 days) combined with rituximab, gemcitabine, and oxaliplatin. On day 5 after the first treatment of treprizumab, the patient developed rash all over the body and a large area of erythema on the trunk and limbs, accompanied by pruritus and pain, and the exfoliation area of the whole body was more than 30%. Laboratory tests showed white blood cell count 12.4×109/L, neutrophil count 11.5×109/L, erythrocyte sedimentation rate 162-mm/1 h, C-reactive protein 74-mg/L, and procalcitonin 1.09-μg/L. The patient had received antineoplastic therapy with rituximab, gemcitabine, and oxaliplatin and no skin reaction occurred. Stevens-Johnson syndrome induced by treprizumab was considered. Protective isolation care and symptomatic treatments such as glucocorticoid, immunoglobulin, and anti-infection were given. After 23 days of treatments, the patient was improved, and the skin ulceration area decreased to 10%. After 31 days of treatments, regenerated skin appeared under most of the ulcerated skin , and laboratory tests showed erythrocyte sedimentation rate 46-mm/1 h, C-reactive protein 15-mg/L, and procalcitonin 0.04-μg/L.
  • WHO信息
    . 2003, 5(2): 135-135.
  • 安全信息
    . 2006, 8(6): 467-467.
  • 病例报告
    . 2006, 8(6): 454-455.
  • 不良事件
    . 2006, 8(3): 226-226.
  • Ling Yilan
    Adverse Drug Reactions Journal. 2009, 11(3): 196-2.
    A 39-year-old woman with mania received lithium carbonate 0.5 g at noon and 0.75 g in the evening as well as clozapine 12.5 mg at noon and 62.5 mg in the evening for 10 years and more. About one year ago, the patient developed dizziness, asthenia, low extremeities shiver, and hands tremor. On examination, lithium poisoning was suspected. Laboratory test revealed that her serum lithium concentration was 2.4 mmol/L . Lithium carbonate was stopped. An IV infusion of 1000 ml of sodium chloride 0.9% once daily was given, and clozapine was continued. Seven days later, her serum lithium concentration decreased to 0.33 mmol/L and her symptoms gradually improved.
  • 病例报告
    . 2001, 3(1): 47-47.
  • 病例报告
    . 2001, 3(1): 45-45.
  • 不良事件
    . 2006, 8(1): 62-62.
  • 药物滥用
    . 2006, 8(1): 39-40.
  • 病例报告
    . 2005, 7(6): 453-453.
  • 病例报告
    . 2006, 8(2): 132-133.
  • 专题讲座
    . 2003, 5(1): 33-38.
  • 病例报告
    . 2005, 7(1): 10-10.
  • ADR护理
    . 2002, 4(2): 112-113.
  • . 2013, 15(5): 268-1.
  • 病例报告
    ZHOU Gan-ping;LU Qi-zhi;LIN Chun-yan;QUAN Xue-mei
    . 2013, 15(2): 100-2.
    A 62-year-old female patient received an IV infusion of levofloxacin 0.5 g once daily for urinary tract infection, red rash developed on inner side of her upper limbs and back on the same day. The levofloxacin was discontinued and anti-allergic treatments were given. The next day, she received an IV infusion of cefoperazone sodium and sulbactam sodium 4.0 g every 8 hours and clindamycin 0.75 g once daily for pulmonary infection. After six days, she experienced oral mucosal erosion, diffused red swelling and flaccid vesicles appeared on her multiple body regions, and partial exfoliation occurred. Epidermolysis bullosa was diagnosed. Antibiotics were discontinued and an IV infusion of methylprednisolone 80 mg once daily was given. Her skin symptoms relieved after 3 days. The next day, she received an IV infusion of amikacin sulfate 0.4 g every 8 hours for a secondary infection of the skin. The rash appeared again on the same day. Glucocorticoid combined human immunoglobulin and supportive treatments were given. Her symptoms of skin gradually improved.
  • 论著
    Zhang Wei;Wan Suigui;Wang Xi;Sun Xuejing;Liu Congyan;Liu Yan;He Jingjuan;Zhao Hong;Xu Juan
    . 2011, 13(1): 13-4.
    Objective: To explore the efficacy and safety of ciclosporine in treatment of myelodysplastic syndrome (MDS) with erythroid hypoplasia. Methods: Five patients were diagnosed with MDS by routine blood tests ,bone marrow morphology, flow cytometry and karyotype analysis. All patients were treated with ciclosporine 100-200 mg/d. The efficacy was assessed according to the modified criteria of the International Working Group (2006), and adverse reactions were evaluated with Common Terminology Criteria for Adverse Events V3.0. Results: Five patients comprised 3 males and 2 females, aged 47-71 years with median age of 56 years. All patients achieved hematologic improvementerythroid (HI-E) after 1 month of ciclosporine treatment. The hemoglobin levels in 4 patients were 94-146 g/L with average level of 118 g/L after 3 months of treatment ( 1 patient was treated with ciclosporine for only 1 month). The hemoglobin levels in 3 patients were stable. The hemoglobin level in another patient decreased to the level before treatment because ciclosporine was withdraw by himself after 3 months of treatment, and returned gradually to the normal after he took ciclosporine again. Six adverse reactions occurred in 5 patients including gingival hyperplasia (n=3), polytrichia (n=2), and skin pigmentation (n=1), but there was no grade ≥3 adverse reactions Conclusion: Preliminary study results show that ciclosporine is effective and safe in treatment of MDS with erythroid hypoplasia.
  • 安全信息
    . 2007, 9(6): 450-450.
  • Zou Le, Yin Tao, Huang Shiqin, Zhu Ying
    . 2017, 19(5): 353.
    ObjectiveTo understand the occurrence of hepatic dysfunction induced by imipenem-cilastatin sodium in preadult inpatients and analyze the influencing factors.MethodsData of inpatients receiving imipenem-cilastatin sodium treatment  in Xiangya Hospital of Central South University from January 1st, 2016 to December 31st, 2016 were collected and analyzed retrospectively. The patients′ general condition, utilization of imipenem-cilastatin sodium, combined medication, clinical effect, and liver function etc. were recorded. The influencing factors of hepatic dysfunction, especially severe liver injury caused by imipenem-cilastatin sodium were analyzed.ResultsA total of 143 preadult inpatients were enrolled into this study. Of them, 86 patients were males and 57 were females; 61 of them were <1 year old, 9 were 1-3 years old, 6 were 4-10 years old, 67 of them were 11-18 years old, and their median age was 9 years. There were 176 infections in the 143 patients. Most of the infections were respiratory tract infection, sepsis, and septicemia. Imipenem-cilastatin sodium was given via intravenous infusion in all patients. At the same daily dosage, the drug was given every 6 hours in 30 patients (21.0%), every 8 hours in 79 patients (55.2%), every 12 hours in 31 patients (21.7%), once daily in 3 patients (2.1%). Eighty-five patients were given combined drugs that could cause liver dysfunction, such as vancomycin, voriconazole, fluconazole, and azithromycin etc. Of the 143 patients, 59 had hepatic dysfunction (41.3%), 24 had liver injury (16.8%), and 11 had severe liver injury (7.7%). Thirty-four patients with hepatic dysfunction received drugs that could cause liver dysfunction during the imipenem-cilastatin sodium treatment. Occurrence of liver dysfunction was not correlated with any of the following factors: patients′ gender, ages, whether or not having malignant tumor, systemic infections, frequency of administration at the same daily dosage, combination drugs that could cause liver dysfunction, liver-protective drugs use before imipenem-cilastatin sodium treatment (all P>0.05). However, the difference in the incidence of severe liver injury between the <1 year old and 11-18 years old patients was statistically significant [18.0%(11/61) vs. 0(0/67), P<0.001], the difference in the incidence of severe liver injury between the inpatients with malignancies or not was statistically significant [0 (0/46) vs. 11.3% (11/97), P<0.01], the difference in the incidence of severe liver injury between the inpatients whose administration frequency was every 6 hours and once daily was statistically significant [0(0/30) vs. 1/3, P=0.001].ConclusionsNon-adult inpatients who were treated with imipenem-cilastatin sodium were prone to develop hepatic dysfunction. Inpatients at age <1 year or receiving higher single dose are more likely to have severe liver injury.
  • Xiao Yange, Zhang Qianying, Tang Zhihui
    . 2017, 19(3): 220.
    A 13-year-old girl with hyperthyroidism was treated with methimazole 10 mg, 3 times daily, and 10 days later the dose was changed to 15 mg once daily. The red rash broken out on her thighs and back on the 18 day and disappeared 4 days after symptomatic treatments. On day 29 of medication, the patient developed migratory polyarthritis which had aggravation and accompanied rash all over the body. Methimazole was withdrawn on day 29. On day 6 of drug withdrawal, her symptom of polyarthralgia was aggravated. The results of laboratory test showed erythrocyte sedimentation rate (ESR) 69 mm/1 h, interleukin 6 (IL-6) 26.2 ng/L, C-reactionprotein (CRP) 41.2 mg/L, rheumatoid factors< 9.69 U/ml, antineutrophil cytoplasmic antibodies (ANCA) positive, antinuclear antibody (ANA)1 ∶  640 positive (homogeneous particles). She was diagnosed as erythra and polyarthritis due to methimazole. The girl received oral loratadine dispersible tablets 10 mg once daily and ibuprofen suspension 20 ml 3 times daily. On day 13 of symptomatic  treatments, her symptom of arthralgia was alleviated obviously, ESR decreased to 28 mm/1 h, CRP 12.8 mg/L, loratadine dispersible tablets and ibuprofen suspension were stopped. On day 5 of drug withdrawal, her erythra disappeared completely. On day 7 of drug withdrawal, her symptoms of arthralgia disappeared completely. The results of review on day 40 of drug withdrawal showed ESR 5 mm/1 h, ANCA negative.
  • Zhang Xiaolan, Wang Wenge
    . 2016, 18(2): 138.
    A 57-year-old female with vaginitis received oral nifuratel 0.4 g thrice daily and nifuratel vaginal tablets 250 mg once every night for topical use. After 13 days of treatment, the patient developed red rashes on generalized skin with itching. Laboratory tests showed the following values: white blood cell (WBC)  count 7.8×109/L, neutrophil 0.70, lymphocytes 0.20, eosinophil 0.006, platelet (PLT) 185×109/L, and erythrocyte sedimentation rate (ESR)54 mm/1 h. She was given IM injection of diphenhydramine 20 mg, oral loratadine 10 mg and cetirizine 10 mg once daily. But the patient′s symptoms were not improved and her rashes exacerbated and accompanied by fever, her rashes can be seen on both face and body shin accompanied with rashes area and number increasing.Three days later, the patient developed edematous erythema on her trunk and upper limbs, a large pieces of dark red ecchymosis on her both lower limbs. Laboratory test showed ESR was 68 mm/1 h. The patient was diagnosed as anaphylactoid purpura with infection. Nifuratel, loratadine, and cetirizine were stopped and IV infusion of azithromycin 0.5 g and methylprednisolone 80 mg once daily were given. After 2 days of treatments, the rashes partly disappeared,  azithromycin 0.5 g and prednisone 5 mg once daily were given by mouth and 3 days later, the rashes disappeared. Azithromycin was stopped and oral prednisone 5 mg once daily was given . After 4 days of treatment, the rashes completely disappeared. Prednisone was stopped.
  • Li Xingang, Zhao Kun, Lu Yanxia, Zhao Zhigang, Liu Zhenhua
    . 2015, 17(5): 343.
    ObjectiveTo evaluate the correlation between paraoxonase 1 (PON1) Q192R polymorphism and cardiovascular adverse events in patients treated with clopidogrel.MethodsWeb of Knowledge, PubMed, ScienceDirect, Embase, Cochrane Library, China National Knowledge Infrastructure, Wanfang, and CQVIP were searched from the inception to March 2015 and prospective cohort studies in accordance with the criteria were collected. Meta-analysis was performed using RevMan 5.3 software and the results were represented as odd ratio (OR) and 95% confidence interval (CI).ResultsA total of 12 studies and 10 090 patients were included in this Meta-analysis. Of them, 2 113 patients were Asian, 7 396 were European, and 581 were North American; 4 096 patients had QQ genotypes and 5 994 QR+RR genotypes. All studies were high quality. The incidence of cardiovascular adverse events in patients with PON1 192QQ genotypes in Asian group was 8.1% (38/472) and 10.8% (177/1 641) in patients with QR+RR genotypes (OR=1.06, 95%CI: 0.64-1.75, P=0.82). The incidence of adverse events in patients with PON1 192QQ genotypes in North American group was 10.4% (27/260) and 10.9% (35/321) in patients with QR+RR genotypes (OR=0.95, 95%CI: 0.56-1.63, P=0.42). The incidence of adverse events in patients with PON1 192QQ genotypes in European group was 6.5% (217/3 364) and 5.6% (225/4 032) in patients with QR+RR genotypes (OR=1.21, 95%CI: 0.85-1.73, P=0.28). After integrating the 3 subgroups, the incidence of cardiovascular adverse events in patients with PON1 192QQ genotypes was 6.9% (282/4 096) and 7.3% (437/5 994) in patients with QR+RR genotypes (OR=1.13, 95%CI: 0.89-1.44, P=0.33). No statistically significant publication bias or selective bias was found from funnel plot. ConclusionThere were no correlation between the PON1Q192R polymorphism and the cardiovascular adverse events in patients treated with clopidogrel.
  • Liu Zhiyan, Zhao Rongsheng
    . 2017, 19(6): 477.
    An 82-year-old male patient with atrial fibrillation took atorvastatin calcium (20 mg/d) by himself following advise of other person. About one month later, he developed muscular soreness, weakness, and brown urine. The results of laboratory tests showed myoglobin (Mb)>3 000 μg/L, creatine kinase (CK) >16 000 U/L, urea nitrogen 16.0 mmol/L, serum creatinine (Scr) 347 μmol/L, creatinine clearance 15 ml/min. The patient was diagnosed as rhabdomyolysis and acute kidney injury which related to atorvastatin calcium. After the withdrawal of atorvastatin calcium and 13 days of treatments with fluid infusion, alkalizing urine, and diuretic, the patient′s muscular soreness and weakness were improved. The results of laboratory test showed Mb 2 340 μg/L, CK 61 U/L, urea nitrogen 7.1 mmol/L, were Scr 189 μmol/L, and creatinine clearance 30 ml/min. Urine test showed no abnormal results.
  • Li Yi, Yin Fenghua, Lai Bei
    . 2015, 17(4): 318.
    A 72-years-old woman mistook digoxin 40 tablets (10 mg) within 7 days for chronic cardiac insufficiency. She developed nausea, vomiting, blurred vision, xanthopsia, chloropsia and dizziness. After admission, her heart rate was 38 beats/min and blood pressure was 135/75 mmHg. Electrocardiogram revealed atrial fibrillation with 3rd degree atrioventricular block. Digitalis poisoning was diagnosed. She was given oral theophylline 200 mg, intramuscular injection of 10 mg anisodamine. After 2.5 hours, the heart rate did not significantly change. She was given intramuscular injection of atropine 0.5 mg, intravenous infusion of atropine 0.5 mg and 1.0 mg once every 0.5 hour. Her heart rate continued to decline, the lowest heart rate was 19 beats/min, and developed unconsciousness and hallucination. She received isoprenaline 1 mg by a continuous infusion pump delivering 0.5 μg per minute. The heart rate was maintained at about 40 beats/min. On day 2, the patient regained consciousness. Electrocardiogram showed atrial fibrillation with ventricular bigeminy. Isoprenaline was stopped and ventricular bigeminy disappeared. Her heart rate was 38 times/min. On day 5, the blurred vision, xanthopsia and chloropsia disappeared. On day 6, the nausea and vomiting disappeared. On day 8, the electrocardiogram revealed atrial fibrillation with a heart rate of 54 beats/min.
  • Zhang Fan;Zhang Luming;Zhang Wenzhou
    . 2015, 17(1): 70-3.
    A 78-year-old male patient with cerebral infarction received an IV infusion of ozagrel sodium 40 mg twice daily. On day 2, the patient developed purple rash with itching on his feet and left groin. A review of his medical history revealed that he had similar symptoms after taking ozagrel sodium 2 years ago. Ozagrel sodium was withdrawn and anti-allergic therapy was given. On day 3 of ozagrel sodium withdrawal, purple rash occurred on his hands and right groin. He was given an IV infusion of methylprednisolone 40 mg once daily and oral chlorphenamine 4 mg once daily. His symptoms gradually exacerbated, on day 5, the patient presented with blister on the rash and oral-mucosal erosion. It was diagnosed as erythema multiforme induced by drug. Methylprednisolone administration was changed to a 40 mg IV infusion twice daily. Three days later, his erythema was lighter in color than before and no new rashes occurred. Methylprednisolone was stopped. Two days after methylprednisolone withdrawal, the patient experienced aggravated eruption on left foot with pain and a high temperature of 39 ℃. Methylprednisolone 40 mg twice daily was administered again. Three days later, the temperature declined to normal. Eight days later, the rash on the feet, hands, and the groin basically subsided, the pain and itching disappeared, the blister became scabby or exfoliated and the oral mucosa erosion healed. Methylprednisolone was switched to oral prednisone and the dose was reduced each week until the drug stopped. Two weeks after prednisone discontinuation, the rashes disappeared completely.
  • Xiang Qian;Mu Guangyan;Zhao Nan;Zhou Ying;Cui Yimin
    . 2014, 16(5): 259-5.

    Objective To explore the effects of pharmaceutical intervention based on genotype detection on curative effect and safety in hospitalized patients receiving warfarin.MethodsThe medical records of patients hospitalized in the Department of Cardiology, First Hospital of Peking University whose dosages of warfarin were adjusted according to the results of CYP2C9*2, CYP2C9*3, vitamin K epoxide reductase complex subunit (VKORC1)G-1639A genotype testing from June 2013 to March 2014 (experimental group) and the patients received warfarin but did not carry the genotype testing (control group) from June to December 2012 were collected and analyzed retrospectively. The length of hospital stay, administration time of warfarin, proportion of patients whose international normalized ratio (INR) ≥3.0 had happened, incidence of bleeding associated with warfarin, INR values and warfarin dosage on discharging were compared between the patients in the two groups. The correlation of warfarin dosage on discharging and the suggested dosage proposed by clinical pharmacist, the above-mentioned parameters and the genotype in the experimental group were analyzed.ResultsThere were 102 patients in the experimental group comprised 62 male and 40 female with average age of (63±16) years (14-88). There were 140 patients in the control group comprised 89 male and 51 female with average age of (64±13) years (21-85). The patients′ primary diseases included auricular fibrillation, deep vein thrombosis, pulmonary embolism and renal vein thrombus, etc. There were no statistically significant difference between age and sexual distinction in the 2 groups. The average length of hospital stay and average administration time of warfarin in patients in the experimental group were obviously longer than those in the control group [(16.7±8.4) d vs. (12.6±6.0) d, (13.2±8.2) d vs. (9.9±6.1) d, all P<0.001]. There were no statistically significant difference of the proportion of INR≥3.0, incidence of bleeding associated with warfarin, and INR values on discharging between the 2 groups. The warfarin dosage on discharging in patients carried CYP2C9*1/*3 (7 cases) were lower than those in the patients carried CYP2C9*1/*1 (95 cases) in the experimental group [(1.79±0.57)mg/d vs. (3.12±1.13)mg/d,P=0.003]. The warfarin dosage on discharging in patients carried VKORC1-1639 GG (1 case) and VKORC1-1639GA (20 cases) were more than those in the patients carried VKORC1-1639AA (81 cases) in the experimental group [6.00,(3.55±1.63)mg/d vs. (2.87±0.92)mg/d,P=0.002]. The length of hospital stay and administration time of warfarin in patients who INR≥3.0 were longer than those in the patients who INR<3.0 [(24.7±10.9)d vs. (15.2±6.9)d,(21.8±10.9)d vs. (11. 6±6.4)d,all P<0.001] and the dosages of warfarin on discharging was lower than that in the patients who INR<3.0 in the experimental group [(2.50±1.02) mg/d vs. (3.13±1.15) mg/d,P=0.042]. In the control group, the difference of length of hospital stay between the patients who INR ≥3.0 and <3.0 was no statistically significant, the administration time of warfarin in patients who INR≥3.0 was longer that in the patients who INR <3.0 [(12.6±6.5)d vs. (9.3±5.8)d,P=0.015],and the warfarin dosages on discharging was lower than that in the in the patients who INR <3.0 [(2.49±1.17)mg/d vs.(3.11±0.99) mg/d,P=0.007]. The cases of fecal occult blood positive, slightly higher of red blood cell in the urine, and gingival bleeding were 8 and 14 in the experimental group and the control group, respectively. No severe bleeding was appeared in both groups. The bleeding was significantly correlated with the length of hospital stay and the administration time of warfarin in the control group(P=0.001, P=0.008). There was no correlation between bleeding and warfarin curative indexes in the experimental group.ConclusionsThe pharmaceutical intervention based on genotype detection can eliminate the effect of genetic factors on warfarin curative effect, avoid prolonging hospitalization caused by adjusting the dose repeatedly, and have a positive role in determination of warfarin maintenance dose. The pharmaceutical intervention has no effect on safety. It is suggested that the patient who receives warfarin anticoagulant therapy should do the genotype detection.

  • 病例报告
    . 2007, 9(2): 141-142.
  • 病例报告
    Xu Jing;Chen Jie;Luo Ziling
    . 2010, 12(4): 292-2.
    A 69yearold woman was hospitalized for chest pain. On day 2 of admission, the patient had poor sleep at night. She received trazodone 50 mg once daily at bedtime and her symptoms did not improve after 4 days of drug therapy. Trazodone was stopped and changed to citalopram 10 mg at bedtime. But the symptoms did not relieve. Depression was diagnosed and she was given concomitant use of citalopram 20 mg and quetiapine 50 mg at bedtime. She developed urinary hesitancy, straining, and decreased urine volume. On day 6, she experienced difficult urination and urinary retenion. Citalopram and quetiapine were withdrawn and she underwent insertion of an urethral catheter. Five days later, her symptoms improved and spontaneous micturition was restored.
  • 论著
    LI Zhi-fei;XIU Dian-rong;WU Wen-han;LEI Yu-tao;LI Zong-yan
    . 2012, 14(1): 26-5.

    ObjectiveTo compare the analgesic efficacy and safety between domestic disposable postoperative local anesthesia analgesic system and imported disposable intravenous infusion analgesia device. Methods A prospective, randomized, double-center controlled trial was conducted. The subjects who were underwent intra-abdominal or abdominal wall surgeries in Peking University Third Hospital and Peking University First Hospital from January to September 2008 were divided into the test group and the control group by randomized block method. Each group comprised 80 patients. The patients in the test group and the control group used domestic disposable postoperative local anesthetic analgesic system and imported disposable intravenous infusion analgesia device, respectively. Visual analogue scale(VAS), satisfaction’s degree to analgesic systems or device, whether analgesics were used, whether discomfort sensation appeared, whether activities were affected, whether inflammation or leakage of liquid occurred, and whether the adverse reactions or events happened were observed 24 and 48 hours after operation, respectively. ResultsThe test group comprised 47 males and 33 females with average age (50.3±14.6) years. The control group comprised 48 males and 32 females with average age (49.5±12.7) years. There were no significant differences in age, gender, height, body weight, operation types and the initial analgesic VAS scores between the two groups 24 and 48 hours after operation (P>0.05 for all comparisons). There were no significant differences in VAS scores, using of analgesic, degree of satisfaction’s discomfort sensation, affecting of activity and incidence of inflammation between the two groups(P>0.05 for all comparisons). The number of cases with leakage of liquid in the test group (10 cases,12.5%) was higher than that in the control group(2 cases, 2.5%), the difference was statistically significant(P<0.05). The main reason of higher incidence of leakage of liquid in the test group was associated with improper location of infusion catheter of local anesthesia analgesic system. ConclusionBoth domestic disposable postoperative local anesthesia analgesic system and imported disposable intravenous infusion analgesia device have favorable analgesic efficacy and safety.

  • 病例报告
    CHU Yan-qi;WANG Wei
    . 2013, 15(2): 104-2.
    An 80-year-old female patient was given an IV infusion of imipenem and cilastatin sodium 0.5 g every 8 hours for Enterobacter cloacae detected in fluid drainage of incision after intercondylar fracture of femur open reduction and internal fixation. On day 3, the eosinophil count was increased from 230×106/L before using this medicine to 520×106/L. On day 9, her eosinophil count was 770×106/L. On day 11, an IV infusion of vancomycin hydrochloride 1 g every 12 hours was prescribed for coagulase negative Staphylococcus detected in fluid drainage of incision. On day 18, the eosinophil count was 1810×106/L. Imipenem and cilastatin sodium was stopped. On day 21, the patient developed skin rash with pruritus on both lower extremities. She was given anti-allergic therapy. On day 26, her conditions improved, but the eosinophil count was still 2990×106/L. So vancomycin hydrochloride was stopped. The patient′s rash gradually subsided. On day 48, the eosinophil count decreased to 20×106/L.
  • 病例报告
    CUI Jin;ZHU Chong-gui;ZHU Mei;LIU Wei
    . 2012, 14(5): 321-2.
    A 28-year-old woman received an IV injection of methylprednisolone 40 mg once daily for hypophysitis-induced central diabetes insipidus. Two weeks later, her regimen was changed to oral prednisone 10 mg thrice daily and azathioprine 50 mg twice daily. On day 4, the patient developed upper abdominal distension, acid regurgitation and nausea. His symptoms did not improved after symptomatic treatment. Prednisone was discontinued after 1 week. Two weeks later, the patient developed severe upper abdominal pain accompanied by vomiting. Gastroscopy revealed chronic gastritis. Azathioprine was discontinued. The gastrointestinal symptoms markedly improved after 2 days. One week later, the gastrointestinal symptoms disappeared, but her urine volume gradually increased. The patient received oral azathioprine 50 mg again. The same symptoms recurred after 1 hour. His symptoms relieved after symptomatic treatment.
  • 专家论坛
    . 2012, 14(1): 12-3.
  • 病例报告
    . 2002, 4(2): 113-113.
  • 病例报告
    . 2002, 4(4): 258-259.
  • 病例报告
    . 2001, 3(4): 250-250.
  • 病例报道
    . 1999, 1(1): 21-21.
  • 病例报告
    . 2002, 4(6): 411-411.
  • WHO信息
    . 2002, 4(4): 275-275.
  • 病例报告
    . 2004, 6(3): 184-185.
  • 病例报告
    . 2003, 5(6): 405-406.
  • 中毒救治
    . 2006, 8(2): 121-122.
  • 病例报告
    . 2001, 3(1): 43-43.
  • 病例报告
    . 2001, 3(1): 44-44.
  • 病例报道
    . 1999, 1(2): 114-114.
  • 病例报告
    . 2006, 8(4): 306-306.
  • 病例报告
    . 2003, 5(2): 106-106.
  • 病例报告
    . 2006, 8(6): 447-447.
  • ADR术语
    . 2003, 5(2): 137-140.
  • 病例报告
    . 2000, 2(4): 257-257.
  • SARS防治
    . 2003, 5(5): 289-289.
  • WHO信息
    . 2001, 3(1): 55-55.
    为介绍国外ADR发生的情况,本刊经世界卫生组织国际药物监测合作中心同意,将WHO Pharmaceuticals Newsletter等资料中部分内容译成中文,供临床用药参考。
  • Yu Kunpeng, Xu Hongbin
    Adverse Drug Reactions Journal. 2023, 25(10): 607-613. https://doi.org/10.3760/cma.j.cn114015-20230616-00443
    Objective To explore the adherence and its influencing factors of tegafur, gimeracil and oteracil potassium (S-1) treatment in patients with tumor-node-metastasis (TNM) stage Ⅲ gastric cancer after operation. Methods Medical records of adult patients with stage Ⅲ gastric cancer after operation in the Second Affiliated Hospital of Nanjing University of Chinese Medicine from October 2018 to April 2022 and treated with oral S-1 were collected, and the S-1 adherence and its related factors in these patients were retrospectively analyzed according to their S-1 treatment information. Good adherence was defined as completing 8 cycles of S-1 treatment within 186 days (14 days of continuous medication and 7 days of discontinuation as 1 cycle). The patients were divided into good and poor S-1 adherence groups. Univariate and multivariate logistic regression analysis were performed to analyze the factors affecting S-1 adherence of patients. Results A total of 148 patients were entered in the study, including 116 males (78.4%) and 32 females (21.6%), with a median age of 67 (27-85) years. Sixty-nine patients (46.6%) completed ≥ 8 cycles of S-1 treatment within the set time and had good adherence; 79 (53.4%) patients had poor adherence. The reasons for interruption or failure to complete treatments as scheduled in the 79 patients were serious adverse reactions in 30 (38.0%) patients, refusal to treat in 27 (34.2%) patients, and poor curative effect in 22 (27.8%) patients. Univariate and multivariate logistic regression analysis showed that lack of or partial understanding of the disease [odds ratio (OR)=5.368, 95% confidence interval (CI): 1.488-19.370, P= 0.010; OR=3.393, 95%CI: 1.309-8.793, P=0.012], gastric cancer with a course of less than 1 year (OR=10.214, 95%CI: 2.400-43.472, P=0.002), and TNM stage Ⅲa (OR=3.879, 95%CI: 1.522-9.886, P=0.005) were the independent influencing factors of poor adherence to S-1 treatment in patients with gastric cancer. Conclusions Less than half of the gastric cancer patients with stage Ⅲ after operation had good adherence to S-1 treatment. Insufficient understanding of the disease, short duration of gastric cancer, and TNM stage Ⅲa were independent influencing factors for poor adherence to S-1 treatment in gastric cancer patients. Increasing patients′ understanding of the disease and strengthening patient education may be important strate- gies to improve S-1 treatment compliance.
  • Yuan Meng, Yang Chunyan, Wu Yuanzhu, Ye Mingqi, Luan Jiajie
    Adverse Drug Reactions Journal. 2022, 24(10): 549-551. https://doi.org/10.3760/cma.j.cn114015-20220215-00124
    A 69-year-old female patient received olaparide 300-mg orally twice daily after 6 cycles of chemotherapy with albumin paclitaxel+carboplatin regimen after cytoreductive surgery for ovarian cancer. The platelet count (PLT) was 151×109/L before the olaparide treatment, and on the 14th day of medication, her platelet count (PLT) was 17×109/L and platelet-associated immunoglobulin was positive. Immune thrombocytopenia due to olaparib was considered. The patient did not take the drug again. Thrombopoietin, eltrombopag, methylprednisolone, and platelet transfusion were given successively, but the PLT in the patients increased and decreased repeatedly, with the highest being 67×109/L, minimum 4×109/L.
  • 病例报告
    . 2000, 2(4): 262-262.
  • ADR监测与防治
    . 2000, 2(4): 243-244.
  • 病例报告
    . 2001, 3(3): 175-175.
  • WHO信息
    . 2002, 4(1): 60-60.
  • WHO信息
    . 2001, 3(3): 208-208.
  • 病例报告
    . 2006, 8(6): 452-453.
  • 病例报告
    . 2003, 5(4): 262-263.
  • 病例报告
    . 2006, 8(5): 381-381.
  • 病例报告
    . 2006, 8(4): 305-305.
  • 不良事件
    . 2004, 6(6): 397-397.
  • WHO信息
    . 2002, 4(3): 208-208.
  • 病例报道
    . 1999, 1(2): 118-118.
  • 病例报道
    . 1999, 1(2): 85-85.
  • WHO信息
    . 2001, 3(2): 129-129.
  • 不良事件
    . 2005, 7(5): 387-387.
  • 不良事件
    . 2005, 7(5): 392-392.
  • ADR术语
    . 2002, 4(4): 282-284.
  • 不良事件
    . 2006, 8(2): 145-145.
  • 病例报告
    . 2006, 8(2): 112-112.
  • 病例报告
    . 2005, 7(6): 456-456.
  • 病例报告
    . 2005, 7(6): 436-436.
  • 不良事件
    . 2005, 7(3): 231-231.
  • ADE简报
    . 2000, 2(2): 134-134.
  • 病例报告
    . 2005, 7(1): 59-60.
  • 病例报道
    . 1999, 1(1): 40-40.
  • 病例报道
    . 1999, 1(1): 57-57.
  • 病例报告
    . 2002, 4(2): 90-90.
  • 病例报告
    LU Gui-qing;BI Zhi-gang;CHU Xiao-yan;KANG Li;LIU Yan;FU Zhi-liang;YIN Xiao-qing;WANG Yi-ting
    . 2012, 14(4): 249-03.
    A 66-year-old man received carbamazepine 100 mg twice daily for trigeminal neuralgia. On day 10 of therapy, he developed generalized skin rash with pruritus and tenderness. Five days later, his symptoms progressed to ulceration and erosion involving his eyelids, nasal cavity, lips and oral mucosa, along with diffuse maculopapular rash was on his trunk and limbs, and a positive Nikolsky’s sign. Drug-induced bullosa epidermolysis was diagnosed. Carbamazepine was discontinued. He was treated with methylprednisolone, human immunoglobulin, human serum albumin, azithromycin and cyclophosphamide. Ten days later, his rash basically subsided.
  • FEI Xiao-fei;LI Xin-yan;ZHENG Lu
    . 2013, 15(3): 161-2.

    A 37-year-old male underwent the synchronal radiochemotherapy combined with nimotuzumab for stageⅢ nasopharyngeal carcinoma. He received an IV infusion of nimotuzumab 200 mg dissoloved in 0.9% sodium chloride 250 ml on the first, sixth, forty-first, and forty-eighth days, respectively. The intensity-modulated radiation therapy was given from the sixth day to the fifty-first day. Two cycles of the synchronal chemotherapy [an IV infusion of cisplatin 80 mg/(m2·2 d), 3 weeks for a cycle] were given from the twenty-eighth day.The patient reported anosphrasia on the second day after the first IV infusion of nimotuzumab. The symptom of insensitivity to all kinds of smell lasted till the fifty-seventh day when the patient′s condition was improved and he was discharged. The patient reported that he could smell pungent smell one month after discharge for subsequent visit and his olfactory sensation was partly restored on six month′s subsequent visit.

  • 病例报告
    Nie Xina;Pan Qib
    . 2011, 13(1): 52-2.
    A 62yearold woman with type 2 diabetic mellitus was hospitalized with relapsing hypoglycemia. Routine blood tests showed that her eosinophil count and percentage were 1.72×109/L and 25.4%, respectively. Eosinophilia was diagnosed. A review of her medical history revealed that she had received SC aldesleukin 200 million units once every other day for 4 months and more after undergoing radical operation for cancer of the gastric antrum. During the treatment of aldesleukin, her eosinophil counts and percentages were gradually increasing as follows: on day 3, 0.02×109/L and 2.3%; on day 11, 0.33×109/L and 7.4%; on day 26, 3.07×109/L and 38.7%; on day 34, 4.21×109/L and 47.1%. Eosinophilia was considered to be related to aldesleukin. Aldesleukin was discontinued and, two weeks later, her eosinophil count returned to normal range.
  • 病例报告
    Zhou Changfu;Zhang Aixiang;Xia Lingli
    . 2010, 12(5): 369-2.
    A 82yearold woman with hypertensive emergency received sublingual nifedipine 10 mg. Twenty minutes later, the patient presented with asthenia, palpitation, coldness in her extremities, and facial pallor. Her blood pressure was 80/50 mm Hg and pulse rate was 110 beats/min. Electrocardiogram showed sinus tachycardia. She was given blood volume expansion, ECG monitoring, and other supportive and symptomatic treatment. Twenty minutes later, her blood pressure was 120/70 mm Hg and her discomfort including asthenia and palpitation gradually improved. The next day, her blood pressure was elevated again. The abovementioned symptoms recurred after administration of sublingual nifedipine and improved after symptomatic therapy.
  • ADR系列问答
    . 2009, 11(5): 379-1.
  • ADR监测与防治
    . 2000, 2(1): 35-36.
  • 病例报告
    . 1999, 1(3): 182-182.
  • 不良事件
    . 2004, 6(1): 58-58.
  • 中毒救治
    Wei Hongjiang;Cui Xiutao;Yu Gang
    . 2014, 16(4): 242-2.
    A 46-year-old male patient mistook fresh radix aconite kusnezoffii and radix aconiti powder about 5 g and, after 3 hours, he developed consciousness disorder and generalized convulsion. The electrocardiogram showed ventricular flutter with a heart rate of 220 beats/min. Electric defibrillation and an IV push of amiodarone were given immediately. But his heart rhythm did not return to normal. An IV push of amiodarone was given again. Meanwhile an IV push of lidocaine 100 mg and 25% magnesium sulfate 8 ml (2 g) were administered. The heart rhythm normalized. The electrocardiogram revealed frequent multifocal polymorphic ventricular premature contractions. A continuous intravenous infusion of amiodarone and lidocaine via pump was continued. Two minutes later, polymorphic ventricular tachycardia recurred and the heart rate was 180-190 beats/min. None of IV push of amiodarone and lidocaine and electroversion was effective. After the second intravenous push of magnesium sulfate 8 ml (2 g), ventricular tachycardia remained however his heart rate decreased to 160-170 beats/min. So the patient received the third intravenous push of magnesium sulfate 8 ml (2 g) and his heart rate was 140-150 beats/min. Ten minutes later, the forth intravenous push of magnesium sulfate 8 ml (2 g) was given and his heart rhythm normalized. Two hours later, the patient was treated with hemoperfusion. At the first one hour, he had polymorphic ventricular tachycardia four times and every intravenous push of magnesium sulfate 1-2 g was effective. Next day, the patient had no symptoms and the electrocardiogram showed sinus rhythm with a rate of 75 beats/min.
  • 综述
    You Lu
    . 2014, 16(6): 367-3.
    The hematological adverse reactions caused by lamotrigine includes decreasing count of white blood cell, neutrophil, and platelet, as well as disseminated intravascular coagulation. However, patient will not develop obvious clinical symptom. The mechanism of this adverse reactions is not clear and the risk factors include mainly concomitant use of other antiepileptic drugs, initial dose exceeding the recommended dose, too fast dose escalation, and so on. In the initial application and the process of gradually added count of lamotrigine, possible hematological adverse reactions must be alerted. The decision of drug discontinuation and changing should not be simply made only on the basis of leukocyte count. If the examination of bone marrow smear is normal or the ratio of bone marrow precursor cell to precursor cell of red blood cell increases, the drug can still be given. If the above ratio decreases or the level of neutrophil count is less than or equal to 0.5×109/L, the drug should be stopped or switched to other medication. These patients who ever had thrombocytopenia or leucopenia should be monitored regularly and should be treated with the laboratory test once every quarter at least. The surgery should be given very carefully to these patients and platelet function should be examined preoperatively.
  • . 2015, 17(2): 90-93.
  • Yan Xuelian, Xu Linlin, Mei Dan, Ge Nan
    A 64-year-old male lung cancer patient with bone metastasis received oxycodone hydrochloride prolonged-release tablets for pain in right shoulder and back and bilateral hypochondrium. The initial dose was 10 mg twice daily and was increased to 80 mg twice daily gradually. Because of poor analgesic effect, the first fentanyl transdermal patch 4.2 mg was applied and kept pasted for 48 hours. On the third day, the second patch 8.4 mg was given and kept pasted for 72 hours. On the 5th day, the patient developed severe mental symptoms such as agitation and delirium, accompanied by fever and increased heart rate. Midazolam, diazepam, olanzapine, meropenem, and indomethacin suppository were given, but his symptoms were not improved. It was considered that combined use of high dose oxycodone and fentanyl induced delirium. Then, oxycodone hydrochloride prolonged-release tablet was changed to morphine sulfate sustained-release tablet. However, because morphine sulfate sustained-release tablets could not be taken by mouth due to the patient′s agitation, fentanyl was increased to 2 patches (16.8 mg). On the second day, the patient presented with hematuria and serum creatine phosphokinase (CK) increased from 26 U/L 6 days ago to 1 511 U/L. Serotonin syndrome and rhabdomyolysis induced by fentanyl were considered. Fentanyl transdermal patches were removed immediately and continuous intravenous pumping of morphine 2 mg/h was applied. After fentanyl transdermal patch withdrawal, his mental symptoms and hematuria gradually disappeared, body temperature and heart rate returned to normal. Serum creatine phosphokinase decreased to 82 U/L 8 days after fentanyl withdrawal.
  • 安全信息
    . 2014, 16(4): 204-1.
  • 会议纪要
    . 2014, 16(1): 56-1.
  • 安全信息
    . 2014, 16(2): 85-1.
  • Zhang Liang, Lin Feishen, Zhou Qiuyun, Ding Hongzi, Wang Jie
    . 2017, 19(4): 256.
    ObjectiveTo analyze the relationship between pyrazinamide plasma concentration and liver injury in patients with tuberculosis and explore the early prediction method of drug-induced liver injury (DILI) in initial treatment in patients with tuberculosis.MethodsData of tuberculosis patients (all the patients were initially treated, no other complications, and underlying disease) receiving 2HREZ/4HR treatment regimen [isoniazid, rifampicin, ethambutol, and pyrazinamide were given at the first 2 months of treatment, isoniazid and rifampicin were given at the later 4 months of treatment] in Nanjing Chest Hospital, Medical School of Southeast University from January to December 2016 were collected. According to the pyrazinamide concentration in serum on the 6th day of treatment, patients were divided into 3 groups, the <20 mg/L group, 20-40 mg/L group, and >40 mg/L group. The incidences of DILI in the 3 groups were compared.ResultsA total of 45 patients in accordance with the criteria were collected, including 33 males and 17 females with age from 18 to 50 years and an average age of (34±10) years. Among them, 36 patients had pulmonary tuberculous, 9 patients had tuberculous pleurisy, and 5 patients had tuberculosis meningitis. The pyrazinamide concentrations in serum were 16-51 mg/L and the average concentration was (35±9) mg/L. There were 4 patients in the <20 mg/L group, 28 patients in the 20-40 mg/L group, and 13 patients in the >40 mg/L group. Of the 45 patients, 11 patients developed DILI and the incidence was 24.4%. The pyrazinamide plasma concentrations in the 11 patients with DILI were 26 mg/L to 51 mg/L, 4 patients′ concentrations were  40 mg/L and 7 patients′ concentrations were >40 mg/L. The incidences of DILI in the <20 mg/L, 20-40 mg/L, and >40 mg/L groups were 0/4, 14.2 %( 4/28), and 53.85% (7/13), respectively. The difference between the 20-40 mg/L and the >40 mg/L groups was statistically significant (χ2=7.708, P=0.008).ConclusionsThe DILI incidence in initial treatment of tuberculosis patients increased with increase of pyrazinamide plasma concentration. Early therapeutic drug monitoring for pyrazinamide could predict the occurrence of DILI and was beneficial for reducing or avoiding the effect of DILL for tuberculosis treatment.
  • ADE简报
    . 1999, 1(3): 190-190.
  • 病例报告
    . 1999, 1(3): 197-197.
  • 中毒救治
    Liu Jingkai;Xu Puqin
    . 2010, 12(6): 421-3.
    Objective: To summarize the treatment experience of acute blasting fume poisoning. Methods: The clinical data from patients with acute blasting fume poisoning in our hospital from October 2007 to November 2009 were collected and retrospectively analyzed. Results: A total of 6 patients were hospitalized. They were all male with mean age 38 years (range 3443 years). The time to disorder onset was 3120 min. All 6 patients developed dizziness, headache, nausea, vomiting, and asthenia. Some of them were accompanied by unconsciousness (4 cases), convulsion (1 case), urinary incontinence (2 cases), dyspnea (2 cases), and so on. Chestexaminations showed one case of peribronchitis and one case of interstitial inflammation in both lungs. Encephalogram examination revealed one case of lowamplituded slow waves. After hyperbaric oxygen, symptomatic and supportive treatments, the 6 patients all improved and were discharged; two of them still had mild dizziness and headache. Conclusion: Early diagnosis and timely treatment with hyperbaric oxygen as well as symptomatic and supportive therapy are effective measures for successful management of acute blasting fume poisoning.
  • 安全信息
    . 2011, 13(6): 400-1.
  • CHEN Run-hua;ZHANG Chang;LI Xiao-hong;HAN Hai-xiao;YAO Yu-pu;WANG Zhi-bin;LI Jun-xiang
    . 2013, 15(5): 296-2.
    An 80-year-old man with unresectable advanced esophageal cancer who gave up radiotherapy and chemotherapy received an IV infusion of 1 million U interleukin dissolved in 100 ml of 0.9% sodium chloride once daily, 15 ml compound matrine injection dissolved in 250 ml of 0.9% sodium chloride once daily, and 50 ml ranitidine injection into the IV drip bulb twice daily. Before treatment, laboratory tests showed the following values: alanine aminotransferase (ALT) 44 U/L, aspartate aminotransferase (AST) 24 U/L, cholinesterase (CHE) 388 U L, total bilirubin (TBil) 29.2 μmol/L, direct bilirubin (DBil) 7.3 μmol/L, and indirect bilirubin (IBil) 21.9 μmol/L. On day 4 of treatment, laboratory tests showed the following values: ALT 72 U/L, AST 71 U/L, γ-glutamyl transferase (γ-GT) 74 U/L, CHE 3387 U/L, and developed nausea, vomiting and aurigo. On day 29 of treatment, laboratory tests showed the following values: AST 67 U/L, γ-GT 597 U/L, CHE 2734 U/L, alkaline phosphatase (ALP) 151 U/L, TBil 203.0 mol/L, DBil 102.5 mol/L, IBil 100.5 mol/L, albumin (ALB) 32.6 g/L. The compound matrine injection was withdrawn and the liver-protective treatment was given. One month later, his symptoms of nausea, vomiting and aurigo were mitigated and liver function reexamination showed the following values: ALT 15 U/L, AST 21 U/L, γ-GT 59 U/L, ALP 66 U/L, TBil 46.1 mol/L, DBil 16.2 mol/L, IBil 29.9 mol/L.
  • MU Wei-jing;REN Xiao-lei;ZHANG Hai-ying;FENG Wan-yu
    A 72-year-old male received fluoxetine 20 mg daily for 24 months for post-stroke depression (PSD)due to cerebral infarction. After eighteen months of treatment, the patient developed synclonus tremens suddenly but without other complicated syndromes. The patient′s condition improved spontaneously on the next day and did not leave any discomfort. After twenty-three months of treatment, the patient developed similar synclonus tremens two times again.The results of physical and laboratory examinations showed no obvious abnormality. The result of electrocardiogram examination eliminated the seizures and essential tremor. It was considered the suspected 5-serotonin syndrome induced by fluoxetine. Fluoxetine was stopped and the patient had no recurrence of synclonus tremens.
  • 病例报告
    GUO Jian-ming;GU Yong-quan;LI Xue-feng;GUO Lian-rui;CUI Shi-jun;WU Ying-feng;TONG Zhu;WU Xin;ZHANG Jian;WANG Zhong-gao
    . 2012, 14(1): 50-3.

    A 74-year-old female patient underwent synthetic vascular bypass grafts and, after surgery, received an IV infusion of heparin 8.33 U·Kg-1·min-1 via pump, oral clopidogrel 50 mg once daily, sarpogrelate 100 mg thrice daily, and warfarin 3 mg/d. On the second day after surgery, heparin was withdrawn and switched to subcutaneous dalteparin sodium 0.4 ml once every 12 hours. On day 7 after surgery, her platelet count was 301×109/L and dalteparin sodium was stopped. Meanwhile, simvastatin 20 mg/d was added to the regimen and oral clopidogrel, sarpogrelate, and warfarin were given according to original dosage. At the sixth postoperative month, warfarin was discontinued and other three medications were continued. At that moment, reexamination showed a platelet count of 240×109/L. At the ninth postoperative month, retests revealed that the platelet count decreased to 1×109/L and the levels of white blood cell and hemoglobin were normal. Clopidogrel and sarpogrelate were withdrawn immediately and oral simvastatin was continued. At 4 weeks after discontinuation, her platelet count returned to 156×109/L.

  • 误用滥用
    REN Ai-min;LI Hong;SHEN Shu-feng;LIANG Dong-zhu
    . 2012, 14(3): 167-2.
    A 29-year-old female self-administered metformin hydrochloride 500 mg thrice daily to lose weight. About one year later, she developed fever, upper abdominal pain, vomiting, yellowish urine, and clay-like stool. The liver function tests revealed the following levels: alanine aminotransferase(ALT)782 U/L, aspartate aminotransferase(AST)346 U/L, total bilirubin 26 μmol/L, C-reactive protein 23 mg/L. Metformin hydrochloride was withdrawn and liver-protective treatment was given. Fifteen days later, repeat liver function tests showed an ALT level of 65 U/L and an AST level of 50 U/L.
  • 病例报告
    . 2001, 3(4): 251-251.
  • 病例报道
    . 1999, 1(1): 55-55.
  • 病例报告
    . 2002, 4(4): 266-266.
  • 病例报告
    . 2005, 7(3): 213-213.
  • 监测交流
    . 2005, 7(6): 457-458.
  • 监测交流
    . 2006, 8(2): 140-141.
  • 病例报告
    . 2003, 5(1): 46-47.
  • 不良事件
    . 2006, 8(3): 201-201.
  • 不良事件
    . 2004, 6(2): 141-141.
  • 病例报告
    . 2002, 4(1): 8-8.
  • 病例报道
    . 1999, 1(2): 123-124.
  • 病例报告
    Pan Hong
    . 2008, 10(4): 0-0.

    A 64-year-old man was hospitalized with coronary heart disease accompanied by unstable angina pectoris. On hospital day 3, he was infused with sodium ferulate 0.6 g dissolved in 250 ml of glucose 5% at a rate of 3 ml/min. After receiving about 30 ml of the infusion, the man developed persistent angina pectoris, pale face, and fatigue. His BP was 80/50 mmHg; his ECG showed myocardial ischemic change. Sodium ferulate was discontinued. His condition improved after the patient was given with oxygen therapy and placed in the horizontal position. His myocardium enzymogram was within normal ranges. Acute myocardial infarction was excluded. And his angina pectoris was considered to be related to sodium ferulate.

  • 病例报告
    Tu Jianjun;Peng Maolan
    . 2008, 10(4): 0-0.

    A 5monthold girl with infectious diarrhea accompanied by mild dehydration was administered with an IV infusion of 250 ml of glucose 10% mixed with 8 ml of sodium chloride 10% and 3 ml of potassium chloride 10%. Five minutes later, the girl developed chill, fever and dyspnea. The infusion was discontinued. Her condition improved after treatment with dexamethasone. The next day, the girl was given the same fluid again, then anaphylactic reaction reappeared. On day 3, potassium chloride was stopped and other drugs was unchanged. The fluid therapy was continued and anaphylactic reaction did not occur.

  • 不良事件
    . 2004, 6(6): 386-386.
  • 病例报告
    . 2003, 5(2): 112-113.
  • 病例报告
    . 2003, 5(2): 119-119.
  • WHO信息
    . 2003, 5(2): 133-133.
  • WHO信息
    . 2003, 5(2): 134-134.
  • 病例报告
    . 2004, 6(2): 118-118.
  • 病例报告
    . 2001, 3(3): 205-205.
  • 病例报告
    . 2003, 5(3): 191-192.
  • 病例报告
    . 2003, 5(4): 283-283.
  • Zhang Xin, Tong Qingdong, Sun Jiamin
    Adverse Drug Reactions Journal. 2023, 25(10): 638-640. https://doi.org/10.3760/cma.j.cn114015-20220823-00772
    A 20-year-old female patient took compound Zaoren capsules (containing processed ziziphi Spinosae Semen and L-tatrahydropal matine, 1 capsule at bedtime, 12 capsules in total) by herself intermittently due to insomnia. Fifteen days later, she developed fatigue and dark yellow urine. Laboratory tests showed total bilirubin (TBil) 62-μmol/L, direct bilirubin (DBil) 49-μmol/L, alanine aminotransferase (ALT) 1-658-U/L, aspartate aminotransferase (AST) 1-525-U/L, γ-glutamic trans-ferase (GGT) 160-U/L, alkaline phosphatase (ALP) 149-U/L, and total bile acid (TBA) 90.2-μmol/L. She received liver-protective treatments. After 30 days, the symptoms of fatigue and dark yellow urine were relieved, and laboratory tests showed TBil 24-μmol/L, DBil 13-μmol/L, ALT 54-U/L, AST 68-U/L, GGT 170-U/L, and ALP 90-U/L. Nine months later, the patient took compound Zaoren capsules (1 capsule/4 d, 3 capsules in total) again due to insomnia. Fourteen days later, the patient developed yellow sclera and dark yellow urine, and laboratory tests showed TBil 44-μmol/L, DBil 29-μmol/L, ALT 2-041-U/L, AST 1-152-U/L, GGT 110-U/L, ALP 155-U/L, and TBA 28.0-μmol/L. The liver-protective treatments were given again, and the symptoms of yellow sclera and urine were relieved 18 days later. Laboratory tests showed ALT 199-U/L, AST 78-U/L, and GGT 55-U/L. The liver injury is considered to be caused by tetrahydropalmatine in compound Zaoren capsules.
  • Ma Shixin, Li Fei, Wei, Chaoyu, Jin Cailong, Wang Lunqing
    Adverse Drug Reactions Journal. 2023, 25(12): 724-731. https://doi.org/10.3760/cma.j.cn114015-20230627-00472
    Objective To analyze the influencing factors on the prognosis for survival in patients with advanced non-small-cell lung cancer (NSCLC) treated with immune checkpoint inhibitors (ICIs) and to construct a nomogram for predicting the prognosis for survival. Methods The research was designed as a retrospective study. The subjects were selected from advanced NSCLC patients who visited Qingdao Municipal Hospital from January 2019 to December 2021 and received ICIs. The clinical data of patients was extracted through the hospital diagnosis and treatment system. A Cox proportional risk model was used to analyze the factors affecting the prognosis for survival in patients. Patients were randomly divided into the modeling group and validation group according to a ratio of 7∶3. Using R4.2.1-software, a nomogram was built, and its prediction performance was verified based on the bootstrap repeated sampling method. Patients were divided into low- and high-risk groups according to the nomogram. The overall survival (OS) of patients was described through Kaplan-Meier curve, and the difference between the 2 groups was compared using the log-rank test. Results A total of 161 patients with advanced NSCLC were included in the analysis, with an age of (65±8.7) years. Among the 161 patients, 127 were male, 113-had a pathological classification of NSCLC as adenocarcinoma, 86-had an Eastern Coperative Oncology Group Performance Status (ECOG PS) score ≥2, and 113-had ICI combined with other treatments. By December 2022, 81 patients (50.3%) had experienced immune-related adverse events (irAEs), of which 14-had grade 3 or 4 irAEs and 15-had irAEs in multiple systems. Eighty-six patients died. Cox regression analysis showed that advanced lung cancer inflammation index (ALI)≥29.8 [hazard ratio (HR)=0.48, 95% confidence interval (CI): 0.28-0.85, P=0.011], ECOG PS score ≥2  (HR=2.17, 95%CI: 1.21-3.90, P=0.009), and having irAEs (HR=0.40, 95%CI: 0.21-0.76, P=0.005) were prognostic factors for survival in patients with advanced NSCLC treated by ICIs. The nomogram was established based on factors of age, gender, ECOG PS score, irAEs, and ALI, and the total score of each patient was calculated. The patients were divided into the low-risk group (126 cases) and high-risk group (35 cases) according to the optimal cut-off value (183.82) of the receiver operator characteristic curve. The Kaplan-Meier curve and log-rank analysis showed that there was a statistically significant difference in OS between the 2 groups (P<0.00-1). Conclusion ALI, ECOG PS score, and irAEs are independent factors affecting the prognosis for survival in advanced NSCLC patients receiving ICIs, and the nomogram constructed based on multiple biological indicators can effectively predict patient prognosis for survival.
  • 读者·作者·编者
    . 2006, 8(4): 315-316.
  • 不良事件
    . 2006, 8(3): 221-221.
  • 病例报告
    . 2004, 6(5): 354-354.
  • 病例报告
    Zhang Yan;Yao Ying
    . 2009, 11(3): 220-2.
    Two patients developed swelling of submandibular glands and parotid glands due to combined use of ondansetron and lappaconite via an intravenous analgesia pump after surgery. Patient 1, a 30-year-old woman with ovarian tumor and cervicitics, received IV cefodizine and IV ornidazole respectively, and ondansetron 16 mg and lappaconitine 64 mg in 100 ml of sodium chloride injection 0.9% were administered via an intravenous analgesia pump for control of vomiting and relief of pain after undergoing ovarian tumor resection. Nine hours later, swelling of bilateral submandibular glands and parotid glands occurred. The analgesia pump was removed immediately and IV dexamethasone 10 mg was given. After 5 days, her salivary glands swelling subsided. Patient 2, a 42-year-old woman with hysteromyoma and early pregnancy, received an infusion of cefuroxime and an infusion of levofloxacin, respectively, and ondansetron 8 mg plus lappaconitine 40 mg in 95 ml of sodium chloride injection 0.9% were administered via an intravenous analgesia pump for control of vomiting and relief of pain after undergoing subtotal hysterectomy. Eight hours later, the patient developed swelling of bilateral submandibular glands and parotid glands accompanied with palpitation, chest distress and dyspnea. The analgesia pump was removed immediately and IV dexamethasone 10 mg and IM promethazine 25 mg were given. The next day, her salivary glands swelling was markedly subsided and her dyspnea relieved.
  • 实验论著
    Wang Fengyu;Luan Guodong;Ren Leiming*;Wu Zhigang;Wang Xue
    . 2009, 11(4): 243-6.
    Objective: To observe the effect of (-) doxazosin[(-)DOX], (+) doxazosin[(+)DOX], and (±) doxazosin[(±)DOX]on the contraction activity in isolated rabbit ileum and duodenum in order to provide the experimental basis for doxazosininduced digestive system disorders. Methods:The isolated preparations of rabbit ileum, ileal longitudinal muscle, ileal circular muscle, and duodenum were prepared.The ends of each preparation were fixed in the Magnus bath and tension converter, respectively. The experiments were divided into four groups: the (-)DOX group, the (+)DOX group, the (±)DOX group,and the distilled water control group.Each of (-)doxazosin, (+) doxazosin, and (±) doxazosin had three concentrations of 3, 10, and 30μmol/L; 15, 35, and 100 μl of distilled water served as controls. Three different concentrations of (-)DOX, (+)DOX, and (±)DOX, as well as 15, 35, and 100 μl of distilled water were added into the Magnus bath. The contraction frequency and amplitude of ileum, ileal longitudinal muscle, duodenum were measured. In addition, 150 μl of (-)DOX, (+)DOX, (±)DOX, and distilled water was added into to the bath, respectively. Twenty minutes later, carbachol was added into to the bath. The contraction frequency and amplitude were recorded after carbachol administration. Results:The 3 drugs all inhibited the ileum contraction frequency. At (-)DOX, (+)DOX, and (±)DOX concentrations of 30 μmol/L, ileum contraction frequency was(8.2±1.6)/min,(7.1±1.5)/min and(6.8±1.4)/min, respectively; the differences were statistically significant compared with the contraction frequency before drug administration [(11.0±1.5)/min,(10.3±1.7)/min and(10.6±2.1)/min]or the contraction frequency of distilled water[(10.6±1.6)/min](all P<0.01). The 3 drugs all inhibited the contraction frequency of ileal longitudinal muscle. At (-)DOX, (+)DOX, and (±)DOX concentrations of 30μmol/L, the contraction frequency of ileal longitudinal muscle was (10.1±1.5)/min,(9.7±21)/min and(9.0±2.2)/min, respectively; the difference were statistically significant compared with the contaction frequency before drug administration [(12.9±2.8)/min,(13.9±1.7)/min and(13.0±18)/min](all P<0.01).The 3 drugs all did not affect the carbacholinduced contraction activity of ileal circular muscle. The differences were not statistically significant compared with distilled water (all P>0.05).The 3 drugs all inhibited the contraction frequency and contractile force of duodenum.At (-)DOX, (+)DOX, and (±)DOX concentrations of 30 μmol/L, the contraction frequency of duodenum was(11.9±1.2)/min,(14.2±26)/min and(12.5±1.8)/min,respectively; the differences were statistically significant compared with the contraction frequency before drug administration [(16.5±1.4)/min、(17.5±1.8)/min and(15.1±1.5)/min]or the contraction frequency of distilled water [(16.0±2.2)/min](all P<0.01). In addition, the contractile force of duodenum was (0.75±0.44)g,(0.71±022)g and(0.87±0.58)g, respectively ; the difference were statistically significant compared with the contractile force before drug administration[(3.81±0.66)g,(4.12±066)g and(3.96±0.74)g]or the contratile force of distilled water [(3.87±0.70)g](all P<0.01).Conclusion: Doxazosin and its enantiomers all have inhibitory action on contraction frequency of ileum and ileal longitudinal and contraction frequency and amplitude of duodenum; of them, the inhibitory action of (-) doxazosin is relatively weak.
  • WHO信息
    . 2001, 3(4): 264-264.
  • 病例报告
    . 2001, 3(2): 120-120.
  • 不良事件
    . 2002, 4(4): 285-285.
  • 病例报告
    . 2003, 5(1): 38-38.
  • 不良事件
    . 2006, 8(2): 144-144.
  • 病例报告
    . 2000, 2(2): 123-123.
  • 病例报告
    . 2005, 7(4): 296-296.
  • 病例报告
    . 2001, 3(4): 249-250.
  • ZHANG Lu;WU Qing-jun;MAO Jiang-feng
    . 2013, 15(3): 174-2.

    A 69-year -old woman was hospitalized because of repeated cough and cough up phlegm for 4 months and fatigue for one month. The electrolyte analysis revealed a potassium level of 2.4 mmol/L and an electrocardiogram showed flat T waves, fusion of T and U waves, and the heart rate-corrected QT (QTc) interval of 468 ms. Hypokalemia was diagnosed. Potassium supplement treatment was given. However, the potassium level was 3.2-3.3 mmol/L after 2 days of treatment. A careful history taking revealed that the patient had been taking compound licorice tablets by herself for cough for more than 2 months (a total of more than 500 tablets). The compound licorice tablets were stopped and potassium supplement was given continuously. The next day, the patient′s potassium level increased to 4.4 mmol/L and her fatigue relieved. An electrocardiogram showed normalization of T waves and QTc interval. After 3 days of discontinuation of compound licorice tablets, the potassium supplement treatment was stopped. The patient′s potassium level remained 3.6-3.9 mmol/L. Abnormal potassium level did not recur during the 3 months of follow-up.

  • 病例报告
    Su Dan;Luo Can
    . 2011, 13(5): 318-2.

    A 74-year-old man received an IV infusion of levofloxacin 0.3 g once daily and 6 Zhenqifuzheng capsules twice daily for hydrothorax and chronic obstructive pulmonary diseases. His platelet count was 108×109/L before treatment and, on days 13 and 14 after drug administration, his platelet count dropped to 10×109/L and 7×109/L, respectively. Levofloxacin and Zhenqifuzheng capsules were withdrawn. He received platelet transfusions for three days, IV infusions of cefmetazole sodium 2.0 g twice daily, calf spleen extractive injection 10 ml once daily, and oral berbamine hydrochloride 112 mg 3 times a day. Twelve days later, his platelet count returned to 105×109/L.

  • 病例报告
    Ye Jin;Wang Jingwen
    . 2011, 13(4): 246-2.

    A 74-year-old woman with herpes zoster received IM cobamamide 1 mg/d for 3 days, oral vitamine B1 10 mg thrice daily, and oral ribavirin 0.4 g every eight hours. Three days later, the patient developed dizziness, asthenia, and anorexia. Six days later, she experienced dizziness with unconsciousness lasting several seconds, followed by nausea and palpitation. Laboratory examination revealed a Hb level of 75 g/L and a reticulocyte count of 9.2%. Anemia was considered to be associated with ribavirin and then the drug was withdrawn. One week after drug withdrawl, routine blood tests showed a Hb level of 95 g/L and a reticulocyte count of 9.5%. Thirty-seven days after drug withdrawl, her routine blood test results returned to normal and her symptoms improved gradually.

  • 病例报告
    Chen Huiyun
    . 2010, 12(5): 368-2.
    A 71yearold man received nitrendipine 10-20 mg daily for the treatment of hypertension.Five years later, he developed gingival hyperplasia. Nitrendipine was stopped and switched to captopril. After 2 weeks, the symptoms of gingival hyperplasia markedly relieved. Subsequently, he received nitrendipine again due to frequent cough caused by captopril, and then gingival hyperplasia appeared again. The symptoms were aggravated gradually and progressed to affect occlusion. The symptomatic treatment was ineffective. Nitrendipine was discontinued again. One week later, gingival hyperplasia relieved and, 2 weeks later, his discomfort disappeared and gingival hyperplasia subsided gradually.
  • 临床论著
    Song Weia;Xu Juana;Zhao Yuea;Wang Pingb;Jin Hui;Sun Xuejinga;Su Lia;Li Tao;Ji Bingxina
    . 2010, 12(5): 305-4.

    Objective: To investigate the effects of recombinant human granulocyte colonystimulating factor (rhG-CSF) on the spleen size of healthy donors for hematopoietic stem cells and the related factors. Methods: Twentyeight healthy donors were injected with rhG-CSF 5 μg/(kg·d) subcutaneously for 5 days in order to mobilize hematopoietic stem cell release from bone marrow to peripheral blood. The spleen size (length×thickness) was measured by ultrasound before injection of rhG-CSF and on days 1, 7, and 30 after the last injection. At the same time, the number of neutrophils in the peripheral blood was counted and mean fluorescence intension (MFI) of CD11b was determined. Results: The spleen size was (40.3±3.4) cm2 before injection, (48.2±6.1), (47.8±6.6), and (39.2±5.0) cm2 on days 1, 7, and 30 after the last injection, respectively. The differences in the spleen size were statistically significant between on days 1 and 7 after the last injection and before injection ( all P<0.013). The number of neutrophils in peripheral blood was (3.4±1.0)×109/L before injection, (29.3±6.9)×109/L and (3.2±0.7) ×109/L on days 1 and 7 after the last injection, respectively. The difference in the number of neutrophils was statistically significant between on day 1 after the last injection and before injection (P<0.017). The relative values of MFI of CD11b expression was 57.1±43.5 before injection, 96.8±51.3 and 66.9±30.4 on days 1 and 7 after the last injection, respectively. The difference in the relative values of MFI of CD11b expression was statistically significant between on day 1 after the last injection and before injection (P<0.017). Linear regression analysis showed that spleen enlargement on day 1 after the last injection was related to the number of neutrophils and the expression of CD11b (r=0.603, P=0.000; r=0.436, P=0.023, respectively). Conclusion: The spleen of healthy donors can be enlarged in a short period of time after rhG-CSF injection, which is related to the number of neutrophils in peripheral blood and CD11b expression.

  • 病例报告
    Shen Lirua;Liu Lilib;Bi Ruia; Shan Bingjub
    . 2010, 12(5): 361-2.
    A 48yearold man with left lung adenocarcinoma received erlotinib 150 mg once daily orally for maintenance treatment after the chemotherapy regimen with paclitaxel and cisplatin. After 3 days of erlotinib therapy, he developed widespread acnelike eruptions, cough, tight chest and shortness of breath. Chest CT showed left pleural effusion, an increase in nodule size in left chest wall, mediastinal pleura and interlobar pleura, and interstitial inflammatory changes in lower lobus of the lungs. Mezlocillin/sulbactam and methylprednisolone were given, and he continued receiving erlotinib. Two weeks later, his symptoms relieved,mezlocillin/sulbactam and methylprednisolone were discontinued. After 4 days of erlotinib use alone his eruptions became aggravated, interstitial pneumonia relapsed with fever and abnormal renal function (BUN 14.6 mmol/L,SCr 172 μmol/L). Erlotinib was discontinued. After receiving one week of antiinfective drug and methylprednisolone therapy again, his skin eruptions vanished and renal function returned to within the normal range. Chest CT showed his interstitial inflammatory symptoms disappeared.
  • Zhang Ping, Liu Hongbo, Chen Yu, Gu Xiu, Zhao Limei, Zhao Li
    . 2016, 18(2): 147.
    A 59-year-old male patient with right lung adenocarcinoma received chemotherapy with TP scheme (paclitaxel and cisplatin).  Ninety minutes after the start of IV infusion of paclitaxel, the patient suddenly developed dyspnea, palpitation, skin flushing, and his blood pressure decreased to 70/40 mmHg (1 mmHg=0.133 kPa).  Dexamethasone 10 mg was given by an intravenous injection and 20 minutes later, his symptoms were still not improved. Then, an IV injection of methylprednisolone 40 mg and an IV infusion of dopamine were given. Ten minutes later, his symptoms partly relieved, but he still had palpitation. Beside electrocardiogram  showed ventricular tachycardia with ventricular rate of 144 beats/min. Lidocaine 50 mg was given by an IV injection and 10 minutes later, his palpitation and dyspnea were improved, his heart rhythm was converted to sinus tachycardia. Oxygen inhalation and desensitization therapies were given. The patient was treated for 11 days and discharged with stable condition. No arrhythmia recurred in the patient.
  • Ji Xiaoying, Jin Xuliang
    . 2017, 19(6): 466.
    A 68-year-old male patient with lung cancer received the treatment of combination of pemetrexed disodium and bevacizumab. About 20 minutes after finishing the IV infusion of pemetrexed disodium injection, the patient suddenly developed suppression in the chest, dyspnea, hyperhidrosis, pale, and cyanosis of lips. His heart rate was 98 beats/min, breathing rate was 24/min, and blood pressure was 70/40 mmHg. He was diagnosed as anaphylactic shock due to pemetrexed disodium. The patient was given nasal catheter oxygen inhalation and ECG monitoring, intravenous injection of adrenalin (1 mg) and  dexamethasone (20 mg), immediately. Thirty minutes later, his symptoms were relieved. About 2 hours after the end of IV infusion of pemetrexed disodium, skin rashes occurred on the patient′s chest. He received intramuscular injection of phenergan 12.5 mg, immediately. Twenty-six minutes later, the rashes disappeared. About 20 minutes after the subsiding of the rashes, he received IV infusion of bevacizumab. The patient did not develop any symptoms.
  • Wei Ju, Tong Yin, Gao Yanrong
    . 2016, 18(4): 307.
    A 65-year-old female patient with iron-deficiency anemia received conventional ferrous succinate 0.1 g thrice daily by mouth. On the second day of treatment, the patient developed nausea, acid reflux, and diarrhea. On the third day and the 4th day, her alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels were 155 U/L and 438 U/L, 470 U/L and 867 U/L, respectively. Acute drug-induced liver injury (DILI) was considered. Ferrous succinate was withdrawn and an IV infusion of polyene phosphatidylcholine 465 mg once daily was given. Her gastrointestinal symptoms relieved and ALT and AST levels returned to 37 U/L and 25 U/L after a week of treatment. Then the patient was given IV infusion of iron sucrose injection 100 mg every other day. Ten days later, hemoglobin level increased to 97 g/L and no gastrointestinal symptoms and liver injury appeared. Then she was discharged. Six months later, the patient was admitted to hospital again because of IDA. Ferrous sulfate and vitamin one pill once daily was given. On the 4th day, the levels of ALT and AST were 98 U/L and 209 U/L, respectively. Ferrous sulfate and vitamin was stopped and liver-protective treatment was given. Three days later, her ALT and AST levels were 36 U/L and 34 U/L. At 3 years of follow-up, it was found that the patient was admitted to hospital many times, IV infusion of iron sucrose injection was given each time, and no liver injury recurred.
  • Li Xinping, Zhang Ping, Li Xiaoyu
    . 2016, 18(4): 309.
    A 71-year-old female patient had an increase in volume of night urine for 2-3 months and her blood calcium level was 3.11 mmol/L by lab tests. It was known by inquiring medical history that the patient took calcium carbonate D3 (containing element calcium 300 mg/pill, 1 pill/d), alfacalcidol (0.5 g/d, increased to 0.75  g/d for 1.5 years), and 2 kinds of health products (variety of vitamins, containing vitamin D3 1000 U and element calcium 500 mg in each tablet, 1 tablet/d; "Joint King", containing vitamin D3 2000 U in each dose, 2 doses/d). In addition, the patient also received losartan potassium and hydrochlorothiazide (containing losartan potassium 50 mg and hydrochlorothiazide 12.5 mg) 1 tablet once daily. Her 25-(OH)D level was >280  g/L. Vitamin D intoxication and hypercalcemia was considered. All drugs and health products were stopped, the patient was adviced to drink more water and increase salt intake, and nifedipine was given for her hypertension. Four days later, the patient′s serum calcium was stable at 2.33-2.41 mmol/L.
  • Li Yueyang, Wang Yan, Zhao Hongwei, Zhang Sixi
    . 2017, 19(3): 237.
    An 81-year-old female patient received indomethacin suppository 3 times within 30 hours because of fever (the first time use was permitted by physician, the other 2 times of use were decided by herself), one piece (100 mg) at each time. Forty hours after the first use of indomethacin suppository and 10 hours after the last use of the medicine, the patient developed symptoms of shock like sweating, dyspnea, nausea, cyanosis of lips, convulsions, loss of consciousness, no response to sound and lower blood pressure together with erythema and maculopapule with pruritus over the whole body. It was considered that indomethacin suppository induced the delayed anaphylactic shock and rashes. Oxygen inhalation, IV infusion of 5% glucose solution 250 ml, 1.0 g calcium gluconate+2.0 g vitamin C+glucose and sodium chloride for injection 500 ml were given immediately. About 1 hour later, her symptoms of shock relieved. Indomethacin suppository was withdrawn and anti-allergy therapy was continued. Six days later, her erythema and papular rashes disappeared.
  • Huang Shan, Song Hongtao, Cui Xiaoping, Xu Haizhen
    . 2017, 19(2): 144-145.
    A 61-year-old man received oral atorvastatin calcium 20 mg at bedtime for cerebral infarction. Thirty minutes later after the atorvastatin calcium administration for the first time, the patient developed chest tightness, asthma, cough and expectoration. His heart rate was 108 beats/min, respiratory rate was 29 times/min, blood pressure was 98/63 mmHg (1 mmHg=0.133 kPa). Blood gas analysis showed the following levels: oxygen partial pressure 71 mmHg, total carbon dioxide 53 mmol/L. It was considered that atorvastatin calcium induced allergic asthma. He was given oxygen inhalation and IV infusions of dexamethasone 5 mg, ambroxol hydrochloride 30 mg and doxofylline 0.2 g. One hour later, the symptoms were improved. The next day, the patient′s respiratory rate was 18 times/min, the heart rate was 76 beats/min, the blood pressure was 101/66 mmHg. The chest tightness and asthma were obviously improved with oxygen partial pressure of 82 mmHg and total carbon dioxide of 32 mmol/L. Atorvastatin calcium was discontinued and switched to rosuvastatin calcium 10 mg at bedtime, the chest tightness and asthma did not recur.
  • Sun Lu, Zhang Bo, Wu Bin, Zhang Qian
    . 2017, 19(1): 31-36.
    ObjectiveTo explore the effects and the related factors of tigecycline on the level of  plasma fibrinogen in hospitalized patients.MethodsThe medical records of the patients who were hospitalized and treated with tigecycline in Peking Union Medical College Hospital from January first 2015 to December 31th were collected. The patients′ age, sexuality, primary disease, infection site, days in ICU, situation of using tigecycline, situation of drug combination, the results of tests of fibrinogen (FIB), prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), total bilirubin (TBil), and alanine aminotransferase (ALT) before and after medication were recorded. The patients were divided into FIB decreasing group (FIB<1.8 g/L) and non FIB decreasing group according to the test results of FIB during the medication. The risk factors of FIB decreasing after administration of tigecycline were analyzed by the Logistic regression method.ResultsA total of 121 patients were enrolled into the analysis. There were 59 cases in the FIB decreasing group and 62 cases in the non FIB decreasing group, respectively. The age of patients, the proportion of cases number of primary disease as shock, dysfunction of blood coagulation or bleeding, the proportion of cases of medication time over 14 days in the FIB decreasing group were higher than those in the non FIB decreasing group [(66±13)years vs. (58±16) years, P=0.004, 76.3% (45/59) vs. 56.4%(35/62), P=0.021, 44.1% (26/59) vs. 21.0% (13/62), P=0.007, 42.4% (25/59) vs. 17.7% (11/62), P=0.003]. The number of kind of combination with other antibiotic or antiviral drugs in the FIB decreasing group were more than those in the non FIB decreasing group [3(2, 4) vs. 2(1, 3), P=0.038]. The valley value of FIB during the medication in the FIB decreasing group [1.4(1.1, 1.6) g/L] was obvious lower than those before medication [3.5(2.8, 4.4) g/L] and after drug withdrawal [1.8(1.5, 2.3) g/L] (all P<0.01 ). The peak values of PT, APTT, TT, and TBil during the medication in the FIB decreasing group were obvious higher than those before medication [17(16, 21) s vs. 14(13, 16) s, 57(47, 81)s vs. 39(33, 46) s, 23(21, 26) s vs. 17(16, 20) s, 26(15, 73) μmol/L vs. 15(10, 25) μmol/L, all P<0.01]. All the indices above-mentioned were returned to the levels before medication after drug withdrawal except TT[20(18, 21) s]. The results of Logistic regression analysis showed that the age (OR=1.043, 95%CI: 1.012-1.074, P=0.006), dysfunc-tion of blood coagulation or bleeding (OR=2.843, 95%CI: 1.151-7.022, P=0.024), and medication time over 14 days (OR=3.570, 95%CI: 1.317-9.876, P=0.012) were the risk factors of FIB decreasing after using tigecycline.ConclusionsThe incidence of FIB decreasing in hospitalized patients after using tigecycline is about half. The age, dysfunction of blood coagulation or bleeding and medication time over 14 days are the risk factors of FIB decreasing after using tigecycline.
  • 病例报告
    Liang Xiangyu;Du Lin; Chai Limin;Xu Yamei
    . 2014, 16(5): 301-2.
    A 66-year-old woman received Zhibituo 0.35 g thrice daily by mouth for hypirlipidemia. Four days after the drug administration, the patient developed ache and weakness of deltoid; 25 days later, the patient developed generalized aching pain, weakness, and hard to walk up and down stairs; on 4 weeks of the drug treatment, laboratory testing showed the following values: creatine kinase (CK) >6 400 U/L, creatine kinase isoenzyme (CK-MB) of 150.7 U/L, lactic acid dehydrogenase (LDH) 611 U/L,alanine aminotransferase (ALT) 52 U/L, aspartate aminotransferase (AST) 121 U/L, blood urea nitrogen 10.1 mmol/L, and creatinine 106 μmol/L. Rhabdomyolysis was diagnosed. The patient received cyclosporine for aplastic anemia for a long time. It was considered that the interaction between Zhibituo and cyclosporin induced the rhabdomyolysis. Zhibituo was stopped and fluid replacement, diuretic, and liver-protective drugs were given. Five days later, the symptoms of generalized aching pain and weakness relieved obviously and CK level decreased to 1 170 U/L. Ten days later, the symptoms of generalized aching pain and weakness disappeared completely and the levels of CK, CK-MB, LDH, ALT, and AST were 59 U/L, 6.3 U/L, 173 U/L, 17 U/L, and 16 U/L, respectively.
  • 病例报告
    Sun Min;Cao Kai;Hu Baoxiang;Si Jigang
    . 2014, 16(5): 313-2.
    A 27-year-old female patient received oral stanozolol 2 mg thrice daily and 4 Zaizao Shengxue tablets(再造升血片)thrice daily, subcutaneous injection of filgrastim 150 μg once daily, recombinant human interleukin-11 2 mg once daily, and recombinant human erythropoietin 10 000 U thrice weekly, and an intravenous infusion of cefmetazole 2 g twice daily combined with supportive treatment of blood component transfusion for leukopenia and thrombopenia. Her fasting blood glucose was 5.3 mmol/L before the medication. Eighteen days later, aplastic anemia was diagnosed and oral cyclosporine 125 mg twice daily was added to the regimen. On day 28 of adding cyclosporine, the level of fasting plasma glucose increased to 9.8 mmol/L and the patient′s diet restricted. On day 36, the level of fasting plasma glucose was 8.2 mmol/L. On day 45, the level of fasting plasma glucose and 2-hour post-meal blood glucose were respectively 10.7 mmol/L and 18.7 mmol/L. The dose of cyclosporine was adjusted to 100 mg twice daily and diabetic diet was given strictly. On day 47, the level of fasting plasma glucose was 7.3 mmol/L and on day 55, the level of fasting plasma glucose was 5.4 mmol/L and the 2-hour post-meal blood glucose was 11.3 mmol/L.
  • Li Ying, Liu Ying, Shi Qiang, Wang Xiaoling
    . 2015, 17(5): 395.
    A 25-day-old male neonate suspected of having congenital heart disease underwent echocardiographic examination. The physician prescribed chloral hydrate mixture 10 ml, oral 2 ml before the examination. The pharmacist just told to take 2 ml, without written dosage indication. Before the ultrasound examination, the parent administered the newborn 10 ml chloral hydrate mixture, and then, he developed apnea during the examination. He received tracheal intubation and intravenous infusion of aminophylline. The next day, he was given oxygen inhalation through nasal tube. Six days later, the infant′s condition was improved.
  • 病例报告
    Xu Weifeng
    . 2010, 12(3): 200-2.
    A 51yearold man was hospitalised for undergoing surgery for tibial plateau fracture. One day before surgery, he received an IV infusion of cefpiramide 1.0 g twice daily. After surgery, cefpiramide was continued. After the end of cefpiramide infusion, he was given an IV infusion of cervus and cucumis polypeptide 24 mg in 0.9% sodium chloride 250 mL once daily. About 20 minutes after infusion start, the patient suddenly developed chest distress, flushing in face and neck, polyhidrosis, and undetectable blood pressure. Electrocardiogram monitoring revealed SaO2 0.81 and a heart rate of 114 beats/min. Cervus and cucmis polypeptide was stopped and he was treated with symptomatic and supportive therapies, and then his symptoms relieved. Subsequently, cervus and cucmis polypeptide was discontinued and cefphiramide infusion were continued for 3 days, his abovementioned symptoms did not recur.
  • 论著
    Wu Shanshan;Zhang Yuan;Sun Feng;Zhan Siyan
    . 2011, 13(3): 147-6.
    Objective: To systematically evaluate the non-fatal heart failure risk occurring in type 2 diabetic patients receiving rosiglitazone therapy. Methods: Medline, ClinicalTrials.gov website and GlaxoSmithKline(GSK) website were searched using “rosiglitazone”,“randomized clinical trial” and “human”as the keywords from the inception to 31 August, 2010. The randomized controlled trials (RCT) to compare non-fatal heart failure risk of rosiglitazone and other hypoglycemic drugs in patients with type 2 diabetes mellitus were collected and meta-analysis were conducted. According to the treatment course, diabetes duration, therapeutic model and type of control, all RCT were divided into different subgroups to undergo meta-analysis; and sensitivity analysis and cumulative meta-analysis were conducted further. Results: A total of 678 related articles were searched and 170 trials were obtained according to the inclusion and exclusion criteria. Of the 170 trials, 99 were openly published on Medline or the website of ClinicalTrials.gov and 71 were published on the website of GSK. The results of meta-analysis showed that the odds ratio (OR) for non-fatal heart failure in the rosiglitazone group was 1.24 (95% CI: 0.99-1.55, P=0.065), compared with the control group. The results of meta-analysis in subgroups showed that the OR for non-fatal heart failure in the rosiglitazone group were 1.42 (95% CI: 1.06-1.90, P=0.019) and 1.01 (95% CI: 0.71-1.44, P=0.958) in the 99 openly published studies and the 71 studies published on the website of GSK, respectively; the OR for non-fatal heart failure in the rosiglitazone group was 1.62 (95% CI: 1.17-2.23, P=0.004) in the 30 studies with the treatment course of ≥52 weeks. In the 21 openly published studies with the treatment course of ≥52 weeks and the 33 studies with the duration of diabetes of ≥5 and<10 years, the OR for non-fatal heart failure in the rosiglitazone groups were 1.79 (95% CI:1.22-2.64,P=0.003) and 1.55 (95% CI: 1.06-2.26, P=0.025), respectively. The results of cumulative meta-analysis showed that the OR value was influenced by the results of the large scale RCT (RECORD) 2009, and there was a positive turning point in 2009. The results of a meta-analysis of the 43 trials with a JADA score of ≥3 showed that the OR for non-fatal heart failure was 1.62 (95% CI:1.17-2.23,P=0.004); of them, the OR values for the 16 trials with the treatment course of ≥52 weeks, the 13 trials with the duration of diabetes of ≥5 and<10 years, and the 19 trials with combined drug therapy were 1.79 (95% CI: 1.24-2.57,P=0.002), 1.76 (95% CI:1.15-2.71,P=0.010), and 1.68 (95% CI:1.11-2.53,P=0.014), respectively. Conclusion: Rosiglitazone may increase the non-fatal heart failure risk in the patients with type 2 diabetes mellitus, particularly in those with long duration of diabetes, receiving long-term medication use and combined drug therapy.
  • 论著
    Huang Jina;Liu Jingb;Zhou Mina;Ji Xiaoli;Qiao Aizhenb;Xue Meib;Zhu Lingb;Wang Hengxiangb
    . 2011, 13(2): 85-5.
    Objective: To evaluate the safety of two bortezomibbased chemotherapy regimens in treatment of patients with multiple myeloma (MM). Methods: The adverse reactions occurring in patients with multiple myeloma while receiving PAD or VMP regimens were retrospectively analyzed using Common Terminology Criteria for Adverse Events v3.0. PAD regimen(bortezomib+epirubicin hydrochloride+dexamethasone) included 4 courses, the first course was 18 days, the second, third and fourth courses were 11 days,respectively. PAD regimen was used for patients with MM who were younger and in relatively good physical condition. VMP regimen(bortezomib+melphalan+prednisone) included 4 courses, each course was 11 days. VMP regimen was used for patients with MM who were elder and in relatively poor physical condition. Results: From March 2008 to December 2010, 16 inpatients with MM in AirForce General Hospital received chemotherapy. Twelve patients (7 males and 5 females with median age of 61 years) received PAD regimen. Four patients (3 males and 1 female with median age of 67 years) received VMP regimen. The main adverse reactions induced by PAD or VMP regimen were thrombocytopenia, neutropenia, peripheral neuropathy, infection, and gastrointestinal reactions. (1)Thrombocytopenia was occurred in 9 patients receiving PAD regimen during courses 2-4, including 7 cases of gradesⅠⅡ thrombocytopenia, 1 case of grade Ⅲ thrombocytopenia , and 1 case of grade Ⅳ thrombocytopenia. Thrombocytopenia was occurred in 2 patients receiving VMP regimen, including 1 case of gradeⅡ thrombocytopenia and 1 case of grade Ⅳ thrombocytopenia. The PAD or VMP regimen was continued uninterruptedly in patients mentioned above. The platelet count in patients with grades Ⅲ and Ⅳ thrombocytopenia returned to normal level after platelet transfusion.(2) Neutropenia occurred in 8 patients receiving PAD regimen during courses 2-4, including 5 cases of gradesⅠ-Ⅱ neutropenia, 1 case of grade Ⅲ neutropenia , and 2 cases of grade Ⅳ neutropenia. Neutropenia occurred in 2 patients receiving VMP regimen during courses 2-4, including 1 case of grade Ⅱ neutropenia and 1 case of grade Ⅳ neutropenia. In the patients with grades Ⅰ-Ⅱneutropenia, the PAD or VMP regimen was continued uninterruptedly. In the patients with grade Ⅲ neutropenia receiving PAD regimen, the chemotherapy was temporarily discontinued and the patients received symptomatic treatment; after neutrophil count returned to normal level, the chemotherapy was continued. In patients with grade Ⅳ neutropenia receiving VMP regimen, the chemotherapy was not discontinued, and the patients received SC recombinant human granulocyte stimulating factor.(3) Peripheral neuropathy occurred in 4 patients receiving PAD regimen, including 3 cases of gradesⅠ-Ⅱ peripheral neuropathy and 1 case of gradeⅢ peripheral neuropathy. Grade Ⅰperipheral neuropathy occurred in 1 patient receiving VMP regimen. In a patient with grade Ⅱ peripheral neuropathy, symptoms improved after adjustment of bortezomib dose decreasing from 1.3 mg/m2 to 1.0 mg/m2. In a patient with grade Ⅲ peripheral neuropathy, PAD regimen was repeated after drug withdrawal and symptomatic treatment.(4) Infection and fever occurred in 4 patients receiving PAD regimen during courses 2-4, 1 patient died from septic shock secondary to pulmonary infection. (5) Loss of appetite, nausea, vomiting, and diarrhea or constipation occurred in 16 patients; regimens were not withdrawn, but they received symptomatic treatment. Conclusion: PAD and VMP regimens are relatively safe in treating patients with MM, and most adverse reactions are mild and tolerable. The withdrawal or dose adjustment of bortezomib should be conducted in patients having relatively serious adverse reactions.
  • 中毒救治
    Lü Fangfang;Li Guoqiang;Yang Bo
    . 2011, 13(5): 301-2.

    A 21-year-old woman attempted suicide after a family quarrel and intentionally ingested 50 tablets of propafenone 50 mg. Two hours later, she developed dizziness and weakness, and was then admitted to hospital. Toxicological analysis of blood revealed a propafenone concentration of 0.023 mg/L. An electrocardiogram showed sinus rhythm and complete right bundle branch block. She received gastric lavage, catharsis, fluid supplementation, adrenaline, and hemofiltration. Four hours after admission, the patient presented with type I respiratory failure and she was intubated and placed on a mechanical ventilator immediately. On day 2 after admission, she received a 2-hour therapy with plasmaphoresis and a total volume of 2000 ml of plasma was exchanged. Subsequently, her blood propafenone olncentration was 0.002 mg/L, so blood purification treatment was discontinued. On day 3, her electrocardiogram was normal. She was weaned from ventilator and received oxygen inhalation via a nasal catheter instead, and then her condition became stable. On day 7, the patient recovered and was discharged.

  • CHU Jing;LI Hong;ZHANG Qiang
    . 2013, 15(5): 273-4.

    ObjectiveTo evaluate anesthetic effect and safety of lumbar anesthesia combined with intravenous dexmedetomidine (DMT) in elderly patients.MethodsThe elderly patients (aged 65 to 75 years) undergoing prostate electrocision through urethra from January 2012 to May 2013 in Logistics College Hospital of Chinese People′s Armed Police Forces were enrolled into this study and were divided into DMT group and control group using a random number table. The patients in the two groups received bupivacaine (5.0 mg/ml) 2.0 ml for lumbar anesthesia. The patients in the DMT group received a slow intravenous bolus of DMT (0.5 μg/kg) before anesthesia and pumped DMT continuously at a rate of 0.5 μg/(kg·h) until the end of operation. The patients in the control group received the same volume of 0.9% sodium chloride solution for injection at the same rate. The anesthetic effects (maximal sensory block plane and regression time, sedation score), adverse reactions and the residence time in post anesthesia care uint were compared between the two groups.ResultsA total of 86 patients were enrolled into this study. DMT group comprised 43 cases with the average age of (69±5) years and the control group comprised 43 cases with the average age of (71±6) years. There were no significant differences in the systolic pressure, diastolic pressure, heart rate, pulse oxygen saturation (SpO2) and maximal sensory block plane of patients during the operation between the two groups. The differences of regression time of maximal sensory block plane, sedation score during operation, incidence of hypotension, incidence of bradycardia, and the residence time in post anesthesia care unit between DMT group and the control group were (223±38)min vs. (155±26) min, (4.2±1.9) vs. (2.1±1.3), 20.9%(9 cases) vs. 2.3%(1 case), 44.2%(19 cases) vs. 4.7%(2 cases), and (245±43)min vs.(195±38) min, respectively. The differences were statistically significant (all P<0.05). The difference in incidence of excessive sedation between DMT group and the control group [9.3%(4 cases)vs. 0] was not statistically significant, the incidence of low pulse oxygen saturation[14.0%(6 cases)vs 0] was statistically significant (P<0.05). The patients who developed hypotension, bradycardia and low pulse oxygen saturation received ephedrine, atropine and oxygen, respectively. The patients′ above-mentioned symptoms were improved after the treatment.ConclusionsLumbar anesthesia combined with intravenously DMT may enhance the effects of analgesia and sedation, and is relatively safe for elderly patients. The clinician should pay attention to the adverse reactions such as hypotension, bradycardia and low pulse oxygen saturation. The monitoring of adverse reactions should be intensified. Once adverse reactions develop, the symptomatic treatment should be given.

  • 病例报告
    . 2004, 6(1): 35-35.
  • 病例报告
    . 2000, 2(1): 48-48.
  • 病例报告
    . 2007, 9(2): 137-138.
  • 病例报告
    . 2002, 4(2): 119-119.
  • 病例报告
    . 2005, 7(4): 297-297.
  • 不良事件
    . 2005, 7(4): 306-306.
  • 病例报告
    . 2002, 4(4): 261-261.
  • 病例报告
    . 2002, 4(4): 265-265.
  • 不良事件
    . 2005, 7(3): 181-181.
  • WHO信息
    . 2003, 5(6): 419-419.
  • 病例报告
    . 2006, 8(2): 142-142.
  • 不良事件
    . 2005, 7(6): 429-429.
  • 病例报告
    . 2000, 2(3): 196-196.
  • WHO信息
    . 2003, 5(1): 61-61.
  • 病例报告
    . 2001, 3(2): 123-123.
  • 病例报告
    . 2001, 3(2): 135-135.
  • 病例报告
    . 2004, 6(2): 115-115.
  • 不良事件
    . 2003, 5(2): 127-127.
  • 病例报告
    . 2003, 5(2): 109-109.
  • 病例报告
    . 2006, 8(6): 456-457.
  • 病例报告
    . 2003, 5(3): 187-188.
  • Mao Zhiyuan, Wang Yu, Liu Juqin, Yao Yibing, Yu Haiyan, Jin Ying, Xia Xiuling, Sun Lulu, Fan Zaiwen
    Adverse Drug Reactions Journal. 2021, 23(12): 663-665. https://doi.org/10.3760/cma.j.cn114015-20210222-00205
    A 71-year-old male patient with advanced lung adenocarcinoma received pemetrexed (0.8 g, IV infusion on the first day) and carboplatin (500-mg, IV infusion on the first day) combined with pembrolizumab (200-mg, IV infusion on the second day) and 21 days was a cycle. Before the third cycle of treatment, the patient developed palpitations, irritability, increased appetite, and emaciation. Laboratory tests showed triiodothyronine (T3) 2.88-nmol/L, thyroxine (T4) 247.90-nmol/L, free triiodothyronine (FT3) 10.57-pmol/L, free thyroxine (FT4) 39.63-pmol/L, thyroid stimulating hormone (TSH) 0.014 mU/L, anti- thyroglobulin antibody (TGAb) 15.9 μg/L, thyroid peroxidase antibody (TPOAb)>1 300.0-kU/L. Immune- related hyperthyroidism was considered, which may be related to pembrolizumab. The above-mentioned treatment was continued due to the patient′s condition, and thiamazole and metoprolol were given orally at the same time. One month later, laboratory tests showed T3-2.50-nmol/L, T4-153.40-nmol/L, FT3-7.70-pmol/L, FT4-33.61-pmol/L, TSH 0.007 mU/L, TGAb 15.7 μg/L and TPOAb >1-300.0 kU/L; 2 months later, laboratory tests showed T3-1.84-nmol/L, T4-81.20-nmol/L, FT3-3.86-pmol/L, FT4-11.56-pmol/L, TSH 1.979 mU/L, TGAb 15.7-μg/L, and TPOAb >1-300.0 kU/L. His symptoms of palpitation and irritability were alleviated.
  • Liu Tong, Su Su, Zhang Yangxin, Yu Siqi, Yan Suying
    Adverse Drug Reactions Journal. 2022, 24(11): 584-590. https://doi.org/10.3760/cma.j.cn114015-20220304-00183
    Objective To understand the prescription medications that may cause or exacerbate heart failure (HF-CEPMs) in elderly outpatients with HF and analyze its influencing factors. Methods Prescriptions for elderly patients with HF in clinic of Xuanwu Hospital, Capital Medical University between January 2016 and August 2020 were collected. According to the list of HF-CEPMs published by the American Heart Association in 2016, HF-CEPMs in prescriptions were identified. The patient′s gender, age, disease diagnosis, medical insurance, therapeutic drugs, visiting departments, physician titles, and other information are extracted from the prescription, and the use of HF-CEPMs in the prescription was descriptively analyzed. The patients were divided into HF-CEPMs group and non-HF-CEPMs group according to whether the prescription included at least one drug in the list of HF-CEPMs. The clinical characteristics, number of drugs, medical insurance, visiting departments, and professional titles of prescription physicians in patients in the 2 groups were compared, and the influencing factors of prescription containing HF-CEPMs were analyzed by multivariate logistic regression. Results A total of 2-418 patients were enrolled, including 1-264 males (52.27%) and 1-154 females (47.73%), with a median age of 80 (65, 99) years and a median number of comorbidities 1 (0, 5). The top 3 comorbidities requiring long-term medication were hypertension (1-233 patients, 50.99%), bronchial asthma (448 patients, 18.53%) and diabetes mellitus (385 patients, 15.92%), and the median number of drugs was 5 (1, 16). Among the 2-418 patients, 254 (10.50%) used HF-CEPMs, including 142 (55.91%) males and 112 (44.09%) females. Two hundred and twenty-four patients (88.19%), 26 patients (10.24%), and 4 patients (1.57%) were treated with 1, 2, and 3 kinds of HF-CEPMs, respectively. The top 5 HF-CEPMs in drug use rates were antihypertensive drugs [4.47% (108/2 418)], pulmonary drugs [2.52% (61/2 418)], antidiabetic drugs [1.99% (48/2 418)], urological drugs [1.12% (27/2 418)], antipyretic and analgesic drugs [1.03% (25/2 418)]. Multiple logistic regression analysis showed that the number of comorbidities ≥1 (1 kind of disease: OR=3.732, 95%CI: 2.246-6.623, P<0.001; more than 2 kinds of diseases: OR=6.054, 95%CI: 3.624-10.788, P<0.001) and the number of prescribed drugs ≥5 (OR=4.003, 95%CI: 2.874-5.693, P<0.001) were independent influencing factors for prescribing HF-CEPMs. Conclusions Antihypertensive drugs, pulmonary drugs, antidiabetic drugs, urological drugs, and antipyretic and analgesics drugs were the most common HF-CEPMs in outpatient prescriptions of elderly HF patients. The number of comorbidities and polypharmacy therapy in elderly outpatients with HF were independent influencing factors for prescribing HF-CEPMs.
  • 病例报告
    . 2005, 7(4): 294-294.
  • WHO信息
    . 2001, 3(3): 207-207.
  • WHO信息
    . 2001, 3(1): 57-57.
  • 病例报告
    . 2006, 8(6): 451-451.
  • 病例报告
    . 2003, 5(4): 260-261.
  • 病例报告
    . 2006, 8(4): 310-310.
  • 系列问答
    . 2009, 11(2): 149-1.
  • WHO信息
    . 2002, 4(3): 209-209.
  • WHO信息
    . 2001, 3(4): 267-267.
  • 病例报道
    . 1999, 1(2): 121-122.
  • 病例报告
    . 2000, 2(3): 197-197.
  • 病例报告
    . 2005, 7(6): 452-453.
  • 不良事件
    . 2005, 7(1): 36-36.
  • 病例报告
    . 2002, 4(2): 101-101.
  • 病例报告
    Liu Haiyan
    . 2010, 12(2): 146-1.
    A 40yearold woman received vitamin C 0.2 g and chlorpheniramine 4 mg for skin itching. Two hours later, the patient developed dizziness, asthenia, and nonprojectile vomiting, followed by stiffness in her extremities, foam from her mouth, and no response to voice stimuli lasting for about 1~2 minutes. Subsequently, she experienced another two seizure episodes. On day 3 after admission, her electroencephalogram revealed moderate abnormalities. She was given diazepam and carbamazepine. Her symptoms did not recur.
  • ADR咨询
    . 1999, 1(2): 79-79.
  • 病例报告
    Tan Xiying
    . 2011, 13(6): 388-1.
    A 87-year-old female patient received moxifloxacin 0.4 g once daily orally for increasing chest tightness and palpitation with short of breath and expectoration. One day later, her regimen was changed to an IV infusion of moxifloxacin 0.4 g once daily. On day 3, the patient experienced agitation, delirium, confusion, and irrelevant speech. And her symptoms aggravated at that night. Moxifloxacin was discontinued and IM diazepam was given. Two days later, the above-mentioned symptoms subsided.
  • 病例报告
    Zhang Huijuan;Guo Qingyin;Ren Xianqing;Zhai Wensheng;Ding Ying
    . 2014, 16(5): 304-2.
    An 8-year-old boy received concomitant treatment with tacrolimus 1.25 mg every 12 hours and prednisone 12.5 mg once every other day for idiopathic membranous nephropathy. Five weeks later, the boy developed polydipsia, polyuria, vomiting, somnolence, and dehydration. Laboratory tests showed the following values: fasting plasma glucose 22.4 mmol/L, blood pH 7.24, standard bicarbonate 12 mmol/L, and urine ketone bodies (+++). The patient was diagnosed with ketoacidosis. Tacrolimus was stopped and he was treated with fluid supplementation 2 125 ml/d and continuous IV infusion of recombinant human insulin 2.5 U/h. After 10 hours, laboratory results indicated that blood pH was 7.40, fasting plasma glucose was 8.5 mmol/L, and detection of urine ketone was negative for two times in a row. Then, his treatment was switched to subcutaneous injection of recombinant human insulin 6.25 U before three meals. After 3 weeks, the fasting plasma glucose was 5.9 mmol/L.
  • Yao Yao, Ge Weihong
    . 2016, 18(3): 234.
    A 73-year-old female changed the dosage of methotrexate from 5.0 mg once a week to 2.5 mg once daily for 14 days. She developed multiple ulcers in lip and oral mucosa,  severe pain and dry mouth. On day 15 she discontinued methotrexate according to the doctor′s advice of another hospital. The results of laboratory test on 7 days after drug withdrawal showed the following values: WBC 0.6×109/L,Hb 79 g/L,PLT 7×109/L,ALT 169 U/L,AST 96 U/L,γ-GT 72 U/L. The patient was diagnosed as reduced blood cells of three lines induced by overdose of methotrexate. She received IV infusion of methylprednisolone 40 mg once daily, rinsed the mouth by 0.9% sodium chloride injection 100 ml plus lidocaine hydrochloride injection 10-20 ml, hypodermic injection of recombinant human granulocyte colony stimulating factor 300 U, IV infusion of virus inactivated frozen plasma 225 ml and apheresis platelets 1 U successively. At the same time she received the symptomatic treatment including  liver-protection, stomach-protection, iron supplement, and calcium supplement. The results of laboratory test on 12 days after the above-mentioned treatment showed the following values: WBC 8.0×109/L, Hb 81 g/L,PLT 208×109/L, ALT 19 U/L, AST 22 U/L, γ-GT 41 U/L.
  • Wang Ye, Huang Bing
    A 58-year-old female patient with compression fracture of the 12th thoracic vertebra intended to undergo closed reduction and pedicle screw fixation and transvertebral fusion of the posterior approach under general anesthesia. Before the operation, sufentanil, etomidate, and cisatracurium besilate were given for anesthetic induction, remifentanil, propofol, and sevoflurane for anesthetic maintenance. Fifteen minutes after anesthetic induction, hypotension and reddish skin on upper limbs appeared, but were neglected. Flurbiprofen, dezocine, and cisatracurium besilate were added and the patient′s blood pressure sharply declined to 51/28 mmHg, accompanied by rashes on her whole body. An immediate injection of adrenaline, methyl prednisolone, atropine and intravenous pumping of dopamine were given. One hour later, the blood pressure was stable. One and a half hours later, choking, coughing, and body movement appeared, the third injection of cisatracurium besilate 6 mg was given. Then the patient′s blood pressure decreased again (85/50 mmHg) and rashes aggravated. It was considered that the patient developed cisatracurium besilate induced anaphylactic shock. Anti-shock treatments were given continuously. The next day, the patient′s life signs were stable and rashes subsided.
  • Liu Miaona, Qian Wenjing, Li Wei, Xiao Wei, Jian Yanlin, Wang Zhaoqin
    Adverse Drug Reactions Journal. 2020, 22(6): 350-354. https://doi.org/10.3760/cma.j.cn114015-20200311-00255
    Objective To explore the safety of chloroquine phosphate treatment in patients with novel coronavirus pneumonia (COVID-19) and provide references for clinical safety medication. Methods Active monitoring for adverse events (AE) was carried out in the Third People′s Hospital of Shenzhen from February to March 2020 during the treatment with chloroquine phosphate in patients with COVID-19. The causal relationship between AE and chloroquine phosphate was evaluated. Results A total of 33 patients were entered in the study, including 16 males and 17 females, aged (43±13) years. The clinical types of COVID-19 in 26 patients (78.8%) were mild, in 7 patients (21.2%) were common. There were 7 patients (21.2%) with basic diseases, including 6 with hypertension and 1 with hypothyroidism. The treatment course of chloroquine phosphate was (8±3) days. During the treatment, a total of 28 cases of AE in 24 (72.7%) of the 33 patients which were probably or possibly related to chloroquine phosphate were detected. The clinical manifestations of AE included abnormal liver function (8/33, 24.2%), gastrointestinal reactions (8/33, 24.2%), neuropsychiatric system reactions (8/33, 24.2%), cardiovascular system reactions (5/33, 15.2%), eye and vision abnormality (2/33, 6.1%), and skin injury (1/33, 3.0%). The severity of AE was grade 1 or grade 2. After drug withdrawal or symptomatic treatments, all the patients′ symptoms were improved and the laboratory tests results returned to normal. Conclusion The adverse effects of chloroquine phosphate in the treatment of patients with COVID-19 are mild, but it is still necessary to strengthen the monitoring.
  • Ma Zhaochao, Si Yanbin, Qing Xin, Yang Jing, Yang Li, Zhao Zhigang
    Adverse Drug Reactions Journal. 2020, 22(9): 518-521. https://doi.org/10.3760/cma.j.cn114015-20200115-00048
    Objective To explore a method to shorten the time for preparation and delivery of cytotoxic antineoplastic drugs in pharmacy intravenous admixture services (PIVAS), so that patients can use drugs in time according to the drug labels. Methods The circumstances of prolonged preparation and delivery time of cytotoxic antineoplastic drugs prepared in PIVAS in Beijing Tiantan Hospital from October 8 to December 31, 2018 were investigated by the project team, the causes were analyzed, and the improvement strategies were made. The drug preparation and delivery time after the improvement strategies was counted and compared with that before improvement to evaluate the improvement effect. Results From 8 October to 31 December 2018, a total of 4 156 bags of cytotoxic antineoplastic drugs were prepared and delivered in PIVAS in our hospital and the delivery time of 951 bags need to be paid attention to. Though the recording time was not accurate, it could be determined that the delivery time of at least 4.7% (45/951) of those bags had been extended. After taking the improvement measures of priority review for prescription of cytotoxic antineoplastic drugs, priority preparation, and delivery by special person from 20 January 2020, the delivery time of drugs was shortened from 2.5-4.5 hours to 0.5-4.0 hours, and the incidence of delivery time prolongation decreased to 0.9% (12/1 281). Conclusions In hospital PIVAS, there was a phenomenon of delivery time prolongation of cytotoxic antineoplastic drugs when the drugs were delivered, which might lead to the storage time of the liquid exceeding the requirements of the drug labels. Priority prescription review and delivery of cytotoxic antineoplastic drugs could effectively shorten the delivery time.
  • Ye Qinglin, Wang Zizhao, Zhang Ning, Li Xianyu, Shi Xiaomei, Sun Jianhua
    A 77-year-old female patient underwent a laparoscopic left radical nephrectomy for renal malignant neoplasm. She received an IV infusion of cefoperazone sodium and tazobactam sodium 2 g about 30 minutes before surgery and an IV infusion of hydrocortisone injection 400 mg during the operation. On the 2nd day after surgery, intravenous infusion of cefoperazone sodium and tazobactam sodium (2 g twice daily) and hydrocortisone injection (200 mg once daily) were given sequentially. On the 3rd day after operation, about 30 min after completion of the IV infusion of hydrocortisone injection, the patient′s blood pressure dropped suddenly to 84/48 mmHg, her heart rate was 150 beats per minute, and clouding of consciousness, lethargy, generalized flush and sweating appeared. Adrenal crisis was considered. Dexamethasone, hydrocortisone, dopamine, epinephrine, and etc. were successively given to rescue her. About 30 minutes later, the patient′s symptoms improved slightly and then the patient was immediately transferred to ICU. In ICU, cefoperazone sodium and tazobactam sodium was continued according to the original scheme, hydrocortisone injection was changed to 150 mg twice daily, and the 2 groups of drugs were infused at 2-hour intervals. At the same time, dopamine 360 mg dissolved in 50 ml of 0.9% sodium chloride injection was administered intravenously via an infusion pump. The patient′s condition improved. On the 7th day after operation, the 2 groups of drugs were intravenously infused sequentially again and the similar symptoms appeared again. The pharmacist considered that the disulfiram-like reactions was caused by the combined use of cefoperazone sodium and tazobactam sodium and hydrocortisone injection and suggested that the two drugs should be discontinued. After the drugs withdrawal, no similar symptoms recurred.
  • Shi Yingqin, Lin Jie
    . 2017, 19(2): 126-127.
    A 52-year-old female patient received compound acetate gossypol tablets 1 pill daily (each one contains acetic acid gossypol 20 mg, vitamin B1 10 mg, vitamin B6 10 mg, potassium chloride 250 mg) for 21 months due to uterine fibroid. The patient developed weakness after 18 months of treatment, muscle soreness and fatigue after about 21 months of treatment. Laboratory tests showed the levels of serum potassium, magnesium, creatine kinase, and myoglobin were 2.0 mmol/L, 0.57 mmol/L, 8 830 U/L, and 977 μg/L, respectively. The compound acetate gossypol tablet was stopped and potassium, magnesium, and other treatments were given. Eight days later, her physical strength recovered, muscle soreness disappeared, and the levels of serum potassium, magnesium, creatine kinase, and myoglobin were 3.6 mmol/L, 0.78 mmol/L, 6 097 U/L, and 113 μg/L, respectively. Treatments of potassium and magnesium supplement continued. Ten days later, her serum potassium was 3.7 mmol/L, magnesium 0.82 mmol/L, creatine kinase 101 U/L, and myoglobin 40 μg/L.
  • . 2017, 19(6): 420.
    ObjectiveTo understand the risk of acute renal injury (AKI) in patients using compound diclofenac sodium injection after surgeries and analyze the influencing factors.MethodsData of patients who had normal renal function before receiving compound diclofenac sodium injection treatment after surgeries in 2015 in the Second Xiangya Hospital of Central South University were collected and studied retrospectively (unmatched case-control study). The patients with AKI after treatment were included in the case group and the patients without AKI were included in the control group. The general condition, postoperative medication, and renal function before and after medication in the 2 groups were compared. The risk and related factors of AKI using compound diclofenac sodium injection were analyzed.ResultsA total of 821 patients were enrolled into this study, including 63 cases in the case group [43 males and 20 females, average age(51±13)years] and 758 cases in the control group [425 males and 33 females, average age(50±14)years]. The proportion of patients with hypertension and liver cirrhosis in the case group was higher than that in the control group [25.4% (16/63) vs. 13.1% (99/758), P=0.009; 9.5%(6/63) vs. 2.8% (21/758), P=0.013], the proportion of patients with general surgeries in the case group was higher than that in the control group [42.9%(27/63) vs. 26.9% (204/758), P=0.007], the proportion of patients with neurosurgery in the case group was lower than that in the control group [15.9%(10/63) vs. 33.5% (254/758), P=0.004],the proportion of patients using compound sodium diclofenac injection within 24 h after operation in the case group was higher than that in the control group [20.6%(13/63) vs. 10.7%(81/758), P=0.017]. The results of binary logistic regression analysis showed that the risk of AKI in patients with hypertension was significantly higher than the other patients with other diseases(OR=2.847, 95%CI: 1.498-5.410, P=0.001); the risk of AKI in patients with compound diclofenac sodium injection treatment within 24 h after operation was significantly higher than that in patients with compound diclofenac sodium injection treatment 24 h after the surgery(OR=1.956, 95%CI: 1.154-3.315, P=0.013).ConclusionThe patients with compound diclofenac sodium injection treatment after surgeries could develop AKI, the combination of hypertension and the use of the drug within 24 hours postoperatively could significantly increase the risk of AKI.
  • 中药不良反应
    Zhang Xuewen
    . 2011, 13(2): 130-2.
    A 29yearold male patient was hospitalized for cranicerebral injury from a traffic accident. During hospitalization, the patient was given an IV infusion of compound Danshen injection 20 ml mixed in 5% glucose 250 ml once daily to improve microcirculation. On day 6 of treatment, he experienced of cutaneous purpura, followed by abdominal pain, joint pain in both lower limbs, and hematuria. Laboratory tests revealed the following levels: urinary occult blood (++), urinary protein (++), platelet count 243×109/L, prothrombin time 13 seconds, and activated partial thromboplastin time 36 seconds. Compound Danshen injection was withdrawn and he received symptomatic and supportive therapies, then his cutaneous symptoms improved. After one week, his rashes disappeared and routine urine tests normalized.
  • 中毒救治
    Wang Kailia;Xu Changjiangb;Jin Jinga;Gao Dengliana;Xing Hanqiana;Yan Lia;Zhao Juna
    . 2011, 13(3): 169-2.
    A 22-year-old man developed nausea and vomiting following suicide attempt taking 120 paracetamol, pseudoephedrine hydrochloride and dextromethorphan hydrobromide tablets/paracetamol, pseudoephedrine hydrochloride, diphenhydramine hydrochloride and dextromethorphan hydrobromide tablets (total dose of paracetamol 39 g). He was hospitalized about 13 hours after ingesting the drug. Laboratory tests revealed following levels and values: ALT 7385 U/L, TBil 26.5 μmol/L, DBil 15.4 μmol/L, PTA 23.1%, and lactate 3.9 mmol/L. Druginduced acute liver failure were diagnosed. He received treatment with liverprotective drugs, molecular adsorbent recirculating system (MARS) , and plasma exchange. On day 13 after admission, the patient nearly recovered to normal condition. Repeat liver function tests showed the following levels: ALT 146 U/L, TBil 16.7 μmol/L, and DBil 8.3 μmol/L; and then he was discharged.
  • 临床论著
    Yang Ting;Xu Bin;Yang Jie;Wang Hongjuan;Zhang Yuxiao; Yin Tong
    . 2010, 12(5): 309-4.
    Objective: To explore the influence of regular followup on efficacy and safety of anticoagulant therapy with warfarin used in patients discharged from hospital. Methods: From January 2009 to January 2010, the patients, who received warfarin therapy for anticoagulation during hospitalization in Center of Cardiology of Chinese PLA General Hospital but did not reach a stable dose and should continue to receive warfarin therapy for >3 months after discharge, were enrolled in this study. The patients were divided into the followup group and the control group by randomdigit table method. All the patients were followedup with telephone interviews. The patients in the followup and control groups were followedup once a week and only once 3 months after discharge, respectively. In telephone interview, the patients were asked about warfarin dosage adjustment, international normalized ratio (INR) value monitoring, combination therapy, dietary habits, and the adverse reactions, such as haemorrhage or thrombosis. In addition, the patients were demanded to regularly determine INR and adjust the warfarin dosage according to the followup results. Results: A total of 200 patients entered this study. They were divided into two groups and each group consisted of 100 patients. The follow-up group comprised 62 male and 38 female with average age of (57.0±16.2) years. The control group comprised 47 male and 53 female with average age of (59.6±13.4) years. The proportion of patients who continued to receive warfarin and reached a stable dose within 3 months of discharge was significantly higher in the followup group than in the control group (75% vs 53%, P=0.00). The proportion of patients who were loss to followup and discontinued warfarin therapy due to noniatrogenic disease was significantly lower in the followup group than in the control group (11% vs 22%, 6% vs 15%, all P=0.04). The proportion of patients who did not received regular monitoring of INR values in the follow-up group was similar to that found in the control group (8% vs 10%, P=0.62). The time from discharge to reach a stable dose was shorter in the fellow-up group than in the control group [(38.7±19.0)d vs (54.5 ± 45.6)d, P=0.03]. The proportion of patients with INR>3 but <4 and INR≥ 4 was significantly lower in the follow-up group [14.7% (11/75)] and 10.7% (8/75), respectively] than in the control group [30.2% (16/53) and 24.6% (13/53), respectively]. The difference was significant (P= 0.04).The proportion of hemorrhage events was lower in the followup group [4.0% (3/75)] than in the control group [11.3% (6/53)], but there was no significant difference (P=0.21). No thrombosis event was observed in both groups during follow-up. Conclusion: Regular follow-up can enhance the compliance and efficacy of warfarin therapy and might decrease the occurrence of hemorrhage events in patients discharged from hospital.
  • WANG Xin;ZHI Xiu-yi
    . 2013, 15(3): 128-4.

    To compare the efficacy and safety of pemetrexed and docetaxel as second-line treatment for elderly patients with advanced non-squamous non-small-cell lung cancer(NSCLC).MethodsThe data of patients with advanced non-squamous NSCLC and ≥65 years old in Department of Thoracic Surgery, Xuanwu Hospital of Capital Medical University from January 2009 to March 2012 were collected and analyzed retrospectively. According to the chemotherapy regimens, the patients were divided into 2 groups: the pemetrexed group (intravenous infusion of pemetrexed 500 mg/m2 on the first day) and the docetaxel group (intravenous infusion of docetaxel 75 mg/m2 on the first day). Each treatment cycle consisted of 3 to 4 weeks. The objective response rate (ORR), disease control rate (DCR), and incidence of adverse reactions after 2 cycles of treatment in the 2 groups were compared.ResultsA total of 146 patients were entered in this study.Of them, 56 patients were in the pemetrexed group, including 30 men and 26 women with an average age of (69.6±4.7) years; and 90 patients were in the docetaxel group, including 62 men and 28 women with an average age of (67.9±4.5) years. There were no significant differences in pathological types, stages, and performance status scores between the 2 groups. After 2 cycles of treatment, the ORR in the pemetrexed group was higher markedly than that in the docetaxel group [32.1% (18/56) vs. 17.8% (16/90),P=0.046]. The differences of the DCR in the pemetrexed and the docetaxel groups were not statistically significant [73.2% (41/56) vs. 77.8% (16/90), P=0.530]. Neutropenia, thrombocy-topenia, anemia, nausea and vomiting, neurotoxicity, alopecia, and ther adverse drug reactions occurred in the 2 groups. The incidence of Ⅲ-Ⅳ levels of eutropenia and alopecia and Ⅰ-Ⅱ levels of neurotoxicity in the pemetrexed group were lower significantly than those in the docetaxel group [7.1% (4/56) vs. 27.8% (25/90), P=0.001; 21.4% (12/56) vs.52.2% (47/90), P=0.000; 17.9% (10/56) vs. 33.3% (30/90), P=0.04)]. There were no occurrence of renal function impairment and chemo treatment-related death in the 2 groups. ConclusionPe-metrexed and docetaxel are both effective in the treatment for elderly patients with advanced non-squamous NSCLC, but pemetrexed is safer than docetaxel.

  • 病例报告
    ZHOU Yan-ping;WU Rong-rong;ZHANG Shi-long;LIU Feng-qun;LING Hai-hui
    . 2013, 15(2): 111-2.
    A 36-year-old male patient with chronic hepatitis B received oral adefovir 10 mg once daily. About 6 months later, the treatment was switched to entecavir 0.5 mg once daily due to poor efficacy. Five months later, adefovir 10 mg once daily was added to his regimen. After 5 months of combination therapy, the patient developed a feeling of numbness on the right metatarsophalangeal joints. His creatine kinase level was 800 U/L. On the fourth day after entecavir withdrawal, his creatine kinase was 257 U/L, and the symptom of right metatarsophalangeal joints numbness was improved.
  • 病例报告
    YAN Nuo;YANG Cheng;GAO Yi-fan
    . 2012, 14(2): 128-2.
    An 42-year-old woman underwent right subtotal thyroidectomy. Preoperatively, her heart rate (HT) was 80 beats/min and blood pressure (BP) was 130/80 mm Hg. Bilateral cervical plexus block was performed with mixture of lidocaine and ropivacaine (2% lidocaine 10 ml+0.894% ropivacaine mesylate 10 ml). Ten minutes later, the patient developed urticaria on her chest, her HR was 110 beats/min and BP 150/110 mm Hg. Subsequently, the urticaria was appeared in abdomen and legs. Her HR was 125 beats/min and BP 160/100 mm Hg. Oxygen and IV dexamethasone 10 mg were given immediately. Five minutes later, her urticaria receded gradually. And IM diphenhydramine 20 mg was given. Five minutes later, her HR was 95 beats/min, BP was 140/90 mm Hg, and the urticaria disappeared completely.
  • 病例报告
    XU Shi-wei;LIU Juan
    . 2012, 14(1): 39-2.
    A 29-year-old woman received metronidazole 0.4 g thrice daily after tooth extraction for prevention and treatment of oral infection. The next day, she developed black coated tongue with ulcer on the lingual surface, metronidazole was discontinued and oral ulcer powder was applied to her affected region. On day 3, the black coated tongue showed lump-like desquamation gradually with pain. On day 4, the black coated tongue desquamated completely and her ulcer has healed. Two days later, the patient self-medicated with metronidazole 0.4 g twice daily for pain and swelling of the gum. The next day of drug therapy, her tongue experienced discoloration again. Metronidazole was stopped and switched to amoxicillin 0.5 g thrice daily, she was given diclofenac sodium codeine phosphate to relieve pain. Two days later, the patient’s tongue returned to normal.
  • 病例报告
    . 2004, 6(1): 40-41.
  • ADR监测
    . 1999, 1(3): 168-168.
  • 安全信息
    . 2007, 9(5): 380-380.
  • 病例报告
    . 2005, 7(4): 293-294.
  • 病例报道
    . 1999, 1(1): 53-53.
  • 病例报告
    . 2003, 5(5): 337-338.
  • ADR护理
    . 2002, 4(6): 394-395.
  • 病例报告
    . 2002, 4(6): 395-395.
  • 不良事件
    . 2003, 5(5): 346-346.
  • 病例报告
    . 2004, 6(3): 179-179.
    Summary A 40-year-old man was admitted to hospital due to palpitation and fever for 1 month,and diagnosed as myelodysplastic syndrome, refractory anemia with excess blasts. Since it was failure to be treated with daunorubicin plus cytarabine for 2 courses, the patient was given an intravenous infusion of arsenious acid 10mg daily. Oliguria in the patient occurred at the 9th day of medication. Arsenious acid was discontinued. The patient's manifestations were hypervolemia and systemic edema. Renal function test showed Cr 225.66μmol/L, BUN 1596.43mmol/L, serum potassium 5.05mmol/L. After limitation of water intake and administration of diuretic drugs,the symptoms with hypervolemia were lessened,the signs disappeared and renal function became normal.
  • 病例报告
    . 2005, 7(6): 433-433.
  • 病例报告
    . 2003, 5(4): 237-237.
  • 病例报告
    . 2001, 3(1): 41-42.
  • 病例报告
    . 2002, 4(3): 190-190.
  • 病例报告
    . 2005, 7(5): 329-329.
  • 病例报告
    Feng Yanhu;Huang Xiaojun
    . 2009, 11(4): 290-2.
    A 66yearold man with depression received paroxetine 20 mg daily. One week later, the patient developed dark urine. After further one week of therapy, yellowish sclera occured. Paroxetine was stopped and his jaundice disappeared 3 weeks later. Subsequently, he received paroxetine 30 mg daily again. Two weeks later, he presented with jaundice again. Liver function tests revealed the following levels: ALT 54U/L, ALP 373.75U/L, TBil 151.73μmol/L, DBil 122.08μmol/L, and IBil 29.65μmol/L. Paroxetine was discontinued, but jaundice was exacerbated. His TBil was 570.8μmol/L, his DBil was 261.1μmol/L, and his IBil was 309.7μmol/L. Prednisone, plasma exchange, and hemoperfusion were given. Two weeks later, his jaundice markedly subsided and his liver function improved. After one month of hospitalization, the patient died from complicated pulmonary infections.
  • 实验论著
    Zhang Huayun;Cheng Dongsheng;Jiang Shanling;Qu Hualing
    . 2009, 11(2): 100-3.
    Objective: To study the safety of oral Hufan films in order to provide scientific basis for clinical safe use of the drug. Methods: In acute toxicity testing, 12 rabbits were divided into the drugexposed group and the control group (6 rabbits in each group). In the drugexposed group, 10 ml of the extract (containing alum 0.14 g/ml) for preparing oral Hufan films were applied on the area (5 cm×5 cm) between rabbit lower lip and gums 6 times daily. In the control group, same dosage and administration of vehicle was used. Twentyfour hours after administration, the changes in the rabbit bodyweight, skin, hair, and mucous membrane were observed and recorded for 7 days. In oral mucous membrane irritation testing, 12 rabbits were divided into the drugexposed group and the control group (6 rabbits in each group). Hufan extract 0.5 ml (containing alum 0.07 g/ml) was applied on the rabbit oral mucous membrane in the drugexposed group 8 times within 4 hours for 7 days. The same dosage and administration of vehicle was used in the control group. The local reactions at the application site of oral mucous membrane were observed, and pathological examination of mucous membrane from respiratory tract was performed. In the skin irritation testing, 16 rabbits were divided into following 4 groups: the normal skin group and the control group, the damaged skin group and the control group (4 rabbits in each group). Seven oral films were applied on the depilated area of skin in each rabbit in the two drugexposed groups and 7 inactive vehicle oral films were applied on the skin in each rabbit in the two control groups once daily for 7 days. Twentyfour hours after last administration the residues were removed with warm water, and skin disorders were observed at 1, 24, 48, and 72 hours. Results: Abnormal changes in the rabbit skin, hair, and mucous membrane were not found in the drugexposed group, compared with the control group. On day 7 after application, one rabbit in the drugexposed group appeared mild congestion in oral mucous membrane, and the rest rabbits did not have local reactions. Pathological examination revealed slight inflammatory cell infiltration in squamous epithelium in only one rabbit in the drugexposed group. One rabbit either in the normal skin group or in the damaged skin group developed erythema 1 hour after application. The erythema relieved 24 hours after application and subsided 48 hours after application. Conclusion: Oral Hufan films is a relatively safe preparation of Chinese herbal medicine in treatment of oral ulcer.
  • 病例报告
    . 2006, 8(4): 292-292.
  • ADR护理
    . 2002, 4(3): 176-177.
    异长春花碱治疗肺癌具有较好疗效,但因其对局部血管刺激性大,易致血管周围皮肤损害。1996年至2000年我院应用该药治疗非小细胞肺癌患者致皮肤损害3例,经应用地塞米松、透明质酸酶、普鲁卡因局部封闭3d,庆大霉素、654—2伤口换药以及紫外线照射2周,皮肤损害患者均治愈。
  • 专题讲座
    . 2005, 7(4): 287-291.
  • Xu Zhenhua, Zhang Qiujian, Dong Meng
    Adverse Drug Reactions Journal. 2022, 24(2): 94-95. https://doi.org/10.3760/cma.j.cn114015-20210315-00298
    A 2-year and 4-month-old girl had vomiting, frequent convulsions, fever, insomnia, irritability, abnormal behavior, limb swing, tachycardia, shortness of breath, etc. after mistaken use of her mother′s weight loss healthcare products for about half an hour. Blood routine and blood biochemical examination showed no obvious abnormalities. Gastric lavage, intracranial pressure reduction, and symptomatic treatments were given, and 11 days later, her symptoms basically disappeared. The identification results of the weight loss healthcare products showed that the main component was sibutramine. Then serotonin syndrome caused by sibutramine poisoning was diagnosed.
  • WHO信息
    . 2002, 4(1): 62-62.
  • 病例报告
    . 2001, 3(3): 193-193.
  • 病例报告
    . 2004, 6(5): 329-329.
  • 病例报告
    . 2006, 8(4): 283-283.
  • ADR监测
    . 1999, 1(2): 111-112.
  • 病例报道
    . 1999, 1(2): 122-122.
  • 不良事件
    . 2003, 5(5): 348-348.
  • 病例报告
    . 2000, 2(3): 194-194.
  • 病例报告
    . 2003, 5(1): 32-32.
  • 病例报告
    . 2006, 8(2): 138-138.
  • 不良事件
    . 2004, 6(3): 199-199.
  • 不良事件
    . 2003, 5(6): 416-416.
  • 不良事件
    . 2002, 4(4): 271-271.
  • 不良事件
    . 2002, 4(4): 256-256.
  • 安全用药
    . 2001, 3(4): 233-234.
  • 病例报告
    . 2005, 7(4): 300-300.
  • ADE简报
    . 2001, 3(4): 259-259.
  • 病例报告
    . 2004, 6(1): 44-45.
  • 病例报告
    . 2004, 6(1): 42-43.
  • 病例报告
    WANG Xiao-yan;WANG Shu
    . 2012, 14(1): 40-2.

    A 15-year-old female patient, who was given oral prednisone with an initial dose of 60 mg/d and a maintained dose of 15 mg/d once every other day for two years because of dermatomyositis, developed fever, headache, vomiting, and weakness of lower limbs. The patient did not have any improvement despite receiving cefoperazone sodium and sulbactam sodium, ribavirin, vitamin C, and vitamin B6. Her symptoms worsened progressively and she became difficult to walk. Physical examination showed a temperature of 38.0 ℃, nuchal rigidity, brown maculae covering bilateral lower limbs with purulent spot in its center, grade Ⅲ muscle strength, hypomyotonia, diminished tendon reflexes, and positive Kernig’s sign and Brudzinski’s sign. Routine cerebrospinal fluid test revealed a large number of fungi, a WBC count of 1×106/L, a protein content of 890 mg/L, a glucose level of 1.4 mmol/L, and a chloride level of 99.7 mmol/L. The indian-ink staining of cerebrospinal fluid showed Cryptococcus neoformans and Cryptococcus neoformans meningitis was diagnosed. The patient died from respiratory and circulatory failure despite active resuscitation.

  • 病例报告
    PENG Yang;SHENG Zhao-hui
    . 2012, 14(1): 54-3.

    A 74-year-old male patient received insulin, arasaponin, and oxiracetam for diabetes mellitus and cerebral circulation insufficiency. On day 3,an IV infusion of cefodizime sodium 1.0 g in 0.9% sodium chloride solution 100 ml twice daily was added to his regimen for pneumonia. On day 5 of combination therapy,his cough and expectoration improved while the patient experienced eruption on trunk and limbs with a high temperature of 39 ℃. Cefodizime sodium, arasaponin, and oxiracetam were all stopped and he was given anti-allergic and other symptomatic therapy.One day after drug discontinuation, his temperature decreased to 37.8 ℃ and the eruption was lighter in color than before. However, new eruption appeared on his head and face. Liver function examinations showed an aspartate aminotransferase (AST) level of 596 U/L, an alanine aminotransferase (ALT) level of 768 U/L, and a total bilirubin (TBil) level of 39.1 μmol/L. After receiving a 7-day anti-allergic and liver protective treatment, his generalized eruption vanished basically and liver function gradually return to normal (AST 56 U/L, ALT 25 U/L, and TBil 12.5 μmol/L). Cefodizime sodium was not administered again and the above-mentioned adverse reactions did not recur after readministration of arasaponin and oxiracetam.

  • 病例报告
    ZENG Yan;FU Wen-jing;WANG Yu-qin
    . 2012, 14(5): 306-2.
    A 65-year-old man with uremia, hypertension, miliary tuberculosis, depression and other diseases received multiple drug therapy. He was given oral citalopram hydrobromide 30 mg at bedtime and oral lorazepam 0.5 mg in the next morning for anxiety. Two hours later, the patient developed mental fatigue, hypopnea, absent breath sounds in bilateral lungs, hyperhidrosis. Blood gas analysis showed the following levels: pH 7.16, PaCO2 80 mm Hg, PaO2 134 mm Hg. The patient was given nikethamide, lobeline, and flumazenil and underwent hemodialysis, hemoperfusion, and assisted mechanical ventilation. He had no improvement in symptoms despite a 3-day resuscitation attempts and died from respiratory and circulatory failure on the fourth day.
  • 病例报告
    . 2013, 15(2): 96-2.
    A 51-year-old woman with hyperthyroidism was given thiamazole 5 mg once daily. Ten days later, the patient presented itchiness, nausea, vomiting, and gray excrements. On day 15, the thiamazole was withdrawn. Laboratory examination revealed the following levels: alanine aminotransferase(ALT) 184 U/L, aspartate aminotransferase(AST) 115 U/L, total bilirubin(TBil) 41.6 μmol/L,and direct bilirubin (DBil) 28.6 μmol/L. The patient was considered as cholestatic liver injury. She was given an IV infusion of sodium deoxyribonucleotide injection 150 mg once daily and coenzyme complex for injection 400 U twice daily. On day 7 of liver-protective treatment, laboratory examination showed the following levels: ALT 150 U/L,AST 67 U/L, TBil 28.7 μmol/L, and DBil 19.1 μmol/L. On day 13, the levels of ALT and AST were 93 U/L,and 57 U/L, respectively. On day 28, the levels of ALT, AST,TBil and DBil were 62 U/L, 45 U/L, 11.1 μmol/L, and 5.8 μmol/L, respectively.
  • 中药不良反应
    Zhang Qiuling;Yang Jia;Lu Yixia
    . 2010, 12(4): 297-2.
    A 59yearold woman received Baishi pills 2.5 g thrice daily for therapy of leucoderma. Two months later, biochemical tests revealed the following values: ALT 394 U/L, AST 171 U/L, γ-GT 63 U/L, ALP 158 U/L, LDH 226 U/L. Baishi pills were stopped and she was given compound glycyrrhizin, inosine, vitamin B6, and glucurolactone. One week later, her liver function normalized.
  • 安全信息
    . 2011, 13(2): 132-1.
  • 病例报告
    Meng Lina;Zhang Yuxiang;Su Jinwen;Yu Jinggang;Chen Ling
    . 2011, 13(2): 118-2.
    A 75yearold male patient with pulmonary tuberculosis was treated with rifampicin 0.6 g once daily, isoniazid 0.3 g once daily; pyrazinamide 03 g thrice daily, and levofloxacin 0.2 g twice daily for pulmonary tuberculosis. Eleven days later, the patient developed red rash accompanied with a maximum temperature of 38 ℃ and,14 days later, the symptoms worsened, so he stopped taking the medicines himself. Subsequently, he had jaundiced skin and sclera, vomiting, edema, and then he was hospitalized. Laboratory tests showed the following levels and values: ALT 652 U /L, AST 5066 U/L, ALP 66 U/L, DBil 30.9 μmol/L, TBil 53.5 μmol/L, SCr 150.0 μmol/L, BUN 13.9 mmol/L, platelet count 65×109/L. Admission diagnosis was as follows: secondary pulmonary tuberculosis; druginduced liver injury; type 1 respiratory failure; renal dysfunction; fibrillation; multiple organ dysfuction syndrome. All antitubercular drugs were discontinued, he was given amiodarone, diphenhydramine, calcium gluconate, hydrocortisone, S-adenosine-L-methionine, as well as other symptomatic and supportive treatments. Two weeks after hospitalization, the patient improved markedly. Laboratory tests showed the following results: ALT 36 U/L, AST 29 U/L, DBil 27.6 μmol/L, TBil 45.5 μmol/L, platelet count 93×109/L, SCr 51.5 μmol/L, and BUN 10.1 mmol/L. Antitubercular treatment was readministered as follows: ethambutol 075 g once daily and, one week later, pyrazinamide 0.1 g thrice daily was added and, 2 weeks later, isoniazid 0.3 g once daily was added. One month after admission, the patient’s condition was stable, and then he was discharged
  • Ma Jingjing, Gao Jie
    . 2016, 18(5): 360.
    A 59-year-old male patient with diffuse large B-cell lymphoma received IV infusion of high-dose methotrexate (MTX) 15 g (8 g/m2). At the first treatment with an IV infusion of methotrexate about 10 min (about 0.8 g), the patient presented with dizziness, flushing, and feeling of cold. MTX was stopped and IV injection of dexamethasone 5 mg was given and 5 minutes later, the patient′s symptoms were improved. The IV infusion of MTX was continued and about 10 minutes later, the patient developed the above-mentioned symptoms again. MTX was stopped again. At the second treatment with the same dose of methotrexate about 10 min (about 0.8 g), the above-mentioned symptoms recurred and relieved after MTX withdrawal and symptomatic treatments. On the 5th day after MTX withdrawal, the patient presented with erythema on buttocks and sacrum, bullous rash on chest, and throat ache and the MTX serum concentration was 0.38 μmol/L. On the 6th day after MTX withdrawal, the patient presented with high temperature (39.5 ℃), white blood cell count 0.36×109/L, neutrophil 0.22×109/L, serum creatinine 151 μmol/L and positive fecal occult blood test. It was suspected that MTX induced allergy and delayed elimination of MTX induced multiple organ injuries. IV infusion of leucovorin was given at a dose of 100 mg every 6 h. Meanwhile, anti-allergy, anti-infection, and nutritional supportive treatments were given. On the 14th day after MTX withdrawal, erythema disappeared and serum creatinine was 96 μmol/L. On the 26th day after MTX withdrawal, white blood cell count was 6.34×109/L, neutrophil was 4.77×109/L, and fecal occult blood test was negative.
  • Zhang Fan, Wang Yan, Chen Fei, Jia Guangwei
    . 2016, 18(5): 347.
    ObjectiveTo establish an active monitoring system of  glycyrrhizic acid preparation related hypokalemia in hospitalized patients.Methods The active monitoring system of glycyrrhizic acid preparation related hypokalemia in hospitalized patients was built based on the hospital information system (HIS), combined with Client/Server (C/S) architecture, 10g Oracle database, C# language, ODBC technology and DDL trigger. According to the pre-investigation′s results, blood potassium <3.5 mmol/L (A), using potassium supplement drugs (B) and sudden withdrawal (C) were as glycyrrhizic acid preparation related hypokalemia triggers. The trigger program was embedded into the HIS. The electronical medical record, s of all discharged patients from June 1,2014 to May 31,2015 were retrieved by two pharmacists-in-charge. The electronical medical records of the patients who used glycyrrhizic acid preparation were selected for trigger detection. The causality between glycyrrhizic acid preparation and kaliopenia in patients who were trigger detection positive were evaluated. The relevance ratio of ADR was counted, and compared with the actual reporting situation of  glycyrrhizic acid preparation related hypokalemia at the same period.ResultsA total of 1405 cases were detected by the active monitoring system The cases comprised of 778 males and 627 females with age 1 to 94 years. The cases with age  ≤20, 21-40, 41-60 and ≥61 were 86 (6.2%), 419 (29.8%), 492 (35.0%), and 408 (29.0%), respectively. The top three departments maximum number of cases were breast and thyroid surgery (319 cases, 22.7%), department of gastroenterology (192 cases, 13.7%), and department of infectious diseases (172 cases, 12.2%). The top three primary diseases were tumor (425 cases, 30.2%), chronic liver disease (263 cases,18.7%), and abnormal liver function (239 cases,17.0%). The top three amount of glycyrrhizic acid preparation were magnesium isoglycyrrhizinate injection (742 cases, 52.8%), compound glycyrrhizin for injection (501cases, 35.6%) and compound glycyrrhizin injection (101 cases, 7.2%). The detection result showed that 637 cases were trigger positive. Among them, the number of 1, 2, and 3 triggers positive were 259 (40.7%), 290 (45.5%), and 88 (13.8%), respectively. The result of causality evaluation showed that the number of definite, likely, maybe were 2, 120, and 78, respectively. The relevance ratio of trigger positive was 31.4% (200/637); the actual situation of  glycyrrhizic acid preparation related hypokalemia reported via National Adverse Drug Reaction Monitoring System the at the same period was 2 cases; the former was 100 times of the latter.ConclusionsThe active monitoring system of glycyrrhizic acid preparation related hypokalemia in hospitalized patients was established successfully. The active monitoring system can improve the detection ratio of glycyrrhizic acid preparation related hypokalemia obviously.
  • 论著
    Zhao Hua;Rao Rong
    . 2014, 16(4): 224-3.
    ObjectiveTo analyze characteristics of drug resistance of Escherichia coli and Klebsiella pneumoniae to provide a basis of clinical rational drug use.MethodsData concerning samples collected from all the clinical departments in computer system of Department of Laboratory Medicine in Fangxian People′s Hospital of Hubei Province from January 2010 to December 2012 were browsed manually. Data of samples from which Escherichia coli and Klebsiella pneumoniae could be isolated were selected. Source of bacterial strains, clinical divisions, bacterial strains producing extended spectrum β-lactamase (ESBL), and drug sensitive test were documented.ResultsThere were 359 bacterial strains of Escherichia coli mainly from urine [121 strains (33.7%)] and 296 bacterial strains of Klebsiella pneumonia mainly from phlegm [165 strains (55.7%)]. Escherichia coli was mainly distributed in intensive care unit [88 strains (24.5%)], general surgery department [69 strains (19.2%)], and neurosurgery [56 strains (15.6%)] while Klebsiella pneumonia was mainly distributed in intensive care unit [69 strains (23.3%)], respiratory medicine [50 strains (16.9%)], and neurosurgery [36 strains (12.2%)]. Of the 359 bacterial strains of Escherichia coli, ESBL could be detected in 175 strains with a detectable rate of 48.7%; of the 296 bacterial strains of Klebsiella pneumonia, ESBL could be detected in 116 strains with a detectable rate of 39.2%. Imipenem, meropenem, cefotetan, and piperacillin/tazobactam showed low drug resistance to ESBL-producing strains. The drug resistance rates of ESBL-producing Escherichia coli were respectively 2.3%, 3.4%, 5.1%, and 8.6% to the above four antibacterial agents and those of Klebsiella pneumonia were 2.6%, 3.4%, 2.2%, and 2.8%, respectively.ConclusionEscherichia coli and Klebsiella pneumonia have high resistance to multiple antibacterial agents and the antibacterial agents should be chosen according to drug sensitivity test and results of ESBL testing.
  • 病例报告
    Ou Dengke;Zhou Xiaoming;Chen Yu;Zhao Limei;Zhao Li
    . 2014, 16(6): 372-2.
    Mezlocillin sodium and sulbactam sodium for injection(2.5 g, once every 12 hours) and azithromycin injection (0.5 g, once daily) were given to a 23-year-old female patient due to the community-aquired mycoplasma pneumonia and acute purulent tonsillitis. On the eleventh day, the treatments above mentioned were changed to oral moxifloxacin 0.4 g once daily because of the improvement of the patient′s condition. Thirty minutes after the moxifloxacin administration for the first time, the patient felt chest tightness, palpitation, fever, and generalized flush accompanied by wheal and papula on her limbs and trunk. The electrocardiogram examination showed double directional or inverted T waves in the precordial leads and prolonged QT period with corrected QT interval 462 ms. Laboratory examination showed creatine kinase (CK) 239 U/L, isoenzyme of creatine kinase (CK-MB) 35 U/L. TypeⅠhypersensitivity reaction was diagnosed. Moxifloxacin was stopped and ananaphylaxis and supportive treatments were given immediately. Three days later, her skin symptoms disappeared, ECG examination result returned to normal. The levels of CK and CK-MB were 40 U/L and 11 U/L, respectively.
  • Chen Zhaoyang, Su Na, Zhu Yanghui, Xu Ting
    . 2017, 19(6): 464.
    A 41-year-old male patient with central diabetes insipidus received desmopressin acetate tablet 0.1 mg once per 8 hours. Eight hours after the third medication, he developed obvious abdominal distension. After that, this condition occurred about 30 min after taking the medicine, especially in the afternoon and evening. There was no abdominal distension if no medication. The dose of desmopressin acetate was adjusted to 0.1 mg per night, but the diabetes insipidus could not be controlled. The dose of desmopressin acetate was adjusted to 0.1 mg twice daily (morning and night, respectively), the patient still felt abdominal distension 10 minutes after medication on night. The dose of desmopressin acetate was adjusted to 0.05 mg at the morning and 0.1 mg in the night, the patient′s abdominal distension was gradually alleviated, and disappeared finally.
  • . 2018, 20(1): 1.
  • Sun Zhenxiao, Yu Xiangfen
    . 2018, 20(1): 55.
    A 53-year-old female patient with bipolar disorder received lithium carbonate 0.25 g twice daily for the first time following the doctor′s advice. On day 4, the dosage of lithium carbonate was increased to 0.75 g once daily. On day 7, the dosage was increased to 1.0 g once daily. On day 8 of administration, the patient developed the symptom of ageusia. Lithium carbonate was withdrawn. The patient′s treatment was changed to sodium valproate extentab 0.5 g twice daily according to the doctor′s order. Ten days later, the patient′s symptom of ageusia was alleviated. Thirty-two days later, her gustatory sense returned to normal.
  • Xiao Mulun, Li Rong, Li Fang
    Adverse Drug Reactions Journal. 2020, 22(12): 707-708. https://doi.org/10.3760/cma.j.cn114015?20200208?00086
    A 63‑year‑old male patient received IV infusions of cefoperazone sodium and sulbactam sodium 3 g once per 8 hours and polymyxin B 500 000 units once per 12 hours for intracranial infection after removal of hematoma by craniotomy. Five days later, intrathecal injection of polymyxin B 50 000 units once daily was added. Before treatments, the patient′s muscle strength of left and right lower limbs were grade 3 and 4, respectively. About 20 minutes after the 4th intrathecal injection of polymyxin B, the patient developed weakness of both lower limbs. About 9 hours later, his muscle strength of both lower limbs decreased to grade 1. Myasthenia of lower limbs was considered to be related to intrathecal injection of polymyxin B. Intrathecal injection and IV infusion of polymyxin B were both stopped and replaced by IV infusions of sulbactam sodium 2 g once per 6 hours and vancomycin 1 g once per 12 hours. Five days later, the patient′s muscle strength of left and right lower limbs recovered to grade 3 and grade 4,  respectively.
  • Wang Yali, Fang Xiaojia, Zhang Qian, Cai De
    Adverse Drug Reactions Journal. 2020, 22(11): 619-624. https://doi.org/10.3760/cma.j.cn114015-20200114-00044
    Objective To explore the occurrence of potentially inappropriate medication (PIM) and its influencing factors in discharge prescriptions in elderly patients with stroke. Methods The medical record data of elderly patients (≥65 years) with stroke, who were discharged from the Department of Neurology in the First Affiliated Hospital of Shantou University Medical College between July 2016 and December 2017, were collected and retrospectively analyzed. There were 2 wards in the Department of Neurology in total, 1 of which had clinical pharmacists to participate in medication management of the discharged patients. The patients′ basic information (gender, age, length of hospital stay, ward, and etc.), discharge diagnosis, and discharge prescriptions were collected. PIM in discharge prescriptions in the patients was evaluated according to the 2019 American Geriatrics Society Beers criteria. The patients were grouped according to their gender, age (65-74, 75-84, ≥85 years), number of diseases (1-5, 6-10, ≥11), Charlson comorbidity index (1, 2, ≥3), length of hospital stay (<15, 16-20, ≥21 d), number of prescribed drugs (1-4, 5-9, ≥10), and with or without clinical pharmacists involving in medication management in the ward, and the occurrence of PIM was compared. The influencing factors of PIM were analyzed using multivariate logistic regression method. Results A total of 435 patients were included in the analysis. Of them, 230 were males and 205 were females, with ages from 65 to 92 years; the number of drugs in discharge prescriptions ranged from 2 to 16, with a median number of 6; 200 patients were in ward with pharmacists participating in the management and 235 patients in ward without pharmacists participating in the management. One hundred and seventy-nine prescriptions were found with PIM in 435 patients and the incidence of PIM was 41.15%. A total of 280 times of PIM were found in 179 prescriptions. Multivariate logistic regression analysis showed that the number of prescribed drugs (≥5) was an independent risk factor for the occurrence of PIM [odds ratio (OR)=2.617, 95% confidence interval (CI): 1.689-4.054, P<0.001], and the participation of pharmacists in discharge medication management was a protective factor for PIM (OR=0.673, 95%CI: 0.457-0.990, P=0.045). Conclusions The incidence of PIM in discharge prescriptions in elderly patients with stroke was 41.15%. The occurrence of PIM was related to the number of prescribed drugs. Pharmacists′ participation in the management of discharge medications helps to reduce the occurrence of PIM.
  • Liu Yan, Zhang Jingyue, Wang Yantao, Ji Rongxing, Zhang Juanjuan, Yu Xiaodong
    Adverse Drug Reactions Journal. 2021, 23(2): 76-82. https://doi.org/10.3760/cma.j.cn114015-20200209-00175
    Objective To analyze the clinical characteristics of thrombocytopenia induced by eptifibatide. Methods Databases such as CNKI, Wanfang, VIP, PubMed, Web of Science, and Embase as of May 31st, 2020 were searched and case reports on eptifibatide-induced thrombocytopenia were collected. Clinical information including patient′s basic characteristics, eptifibatide application, the occurrence of thrombocytopenia, management and outcomes, etc. were collected and analyzed by descriptive statistical method. Results A total of 30 patients were enrolled in the study, including 17 males and 13 females, aged from 34 to 86 years with an average age of 63 years. Eptifibatide was applied because of percutaneous coronary intervention in 20 patients, acute coronary syndromes in 9 patients, and pre-operative cardiology evaluation in 1 patient. The 29 patients with combined medication records were all treated with heparins, of which 25 received aspirin and 22 received clopidogrel at the same time. The platelet count (PLT) in 30 patients was (129-398)×109/L before eptifibatide treatment and decreased to (<1-78)×109/L after treatment; 1, 2, and 27 cases were with mild, severe, and profound thrombocytopenia, respectively. Time from eptifibatide application to thrombocytopenia occurrence was 1-24-h in 29 patients (≤ 6 h in 21 patients) and 174-h in 1 patient (continuous application for 168-h). Of the 30 patients, 10 had no clinical symptoms, 14 had bleeding symptoms (5 of which were accompanied by decreased hemoglobin), 1 had only decreased hemoglobin, and 5 had other symptoms. Except 1 patient who had stopped eptifibatide 6 hours before thrombocytopenia, the other 29 patients stopped eptifibatide immediately after thrombocytopenia occurrence; 7 patients did not receive any other intervention, 1 patient was treated with glucocorticoid and caffeic acid tablets, and the other 22 patients were treated with platelet infusion and red blood cell infusion, etc. Except 1 patient with no record of time to thrombocytopenia improvement, thrombocytopenia was improved 7 hours to 12 days later in the other 29 patients. Three patients were found to have thrombosis after eptifibatide discontinuation and 1 of them died. Thrombocytopenia recurred in 2 patients after the second application of eptifibatide and was all improved after drug withdrawal and treatments but 1 patient died of septic shock and multiple organ failure finally. Conclusions Eptifibatide might cause severe thrombocytopenia, which usually occurred within 6 hours after application and were without bleeding symptoms sometimes. Thrombocytopenia could be improved if eptifibatide was stopped and platelet transfusion was given according to the patient′s condition.
  • 海内外交流
    . 2014, 16(1): 59-2.
  • 安全信息
    . 2014, 16(3): 152-1.
  • Wang Yongzhen, Wang Yanhua, Na Shijie, Dai Feng, Huang Guojin, Hu Di
    . 2015, 17(5): 389.
    A 54-year-old male patient with chronic hepatitis B and liver cirrhosis with upper gastrointestinal hemorrhage was treated with the percutaneous transhepatic embolization of gastroesophageal varices and partial splenic embolization. He received an intravenous ioversol injection 160 ml. About 6.5 hours after intervention, the patient became blind in both eyes. Magnetic resonance imaging (MRI) showed widely fresh brain infarction, but nothing abnormal was found in brain computed tomography. He was given oxygen and dexamethasone, sodium aescinate, mannitol, alprostadil, vinpocetine, ligustrazine, monosialotetrahexosyl ganglioside sodium. Fifty-eight hours after blindness, the eyesight was completely resumed. Two weeks later, MRI showed that the range of cerebral infarcts became smaller, signal intensity was reduced. Fourteen months later, the gastrointestinal hemorrhage did not occur and the eyesight was normal.
  • Tian Qiaohuan, Chen Lifang, Lin Zhanquan, Zhu Jianxin, Zhao Jihong, Ma Liping
    . 2016, 18(6): 473.
    A 9-year-old girl received intravenous infusions of cefuroxime 1.5 g twice daily, fat-soluble vitamins (Ⅱ) 1 bottle once daily and water-soluble vitamin 10 ml once daily after resection of teratoma. Mild chest tightness and irritability appeared after the first infusion of fat-soluble vitamin and water-soluble vitamin. One to three hours after each infusion, her body temperature significantly increased. On day 4, erythematous spotted and patchy maculopapular rashes occurred on her face, ear, trunk, and gradually extended developed to the limbs, hand and foot. Fat-soluble vitamins (Ⅱ) was stopped, and water-soluble vitamins were continued to use. The patient′ body temperature returned to normal and the rash gradually reduced after 12 hours. On the following day, the rash disappeared.
  • 病例报告
    Liu Jianfeng;Feng Qiaofei
    . 2011, 13(2): 127-2.
    A 44yearold woman with acute pharyngitis received an IV infusion of lomefloxacin 0.2 g dissolved in glucose 250 ml twice daily. After 2 days of treatment, she experienced asthenia and hyperhidrosis. Liver function tests showed the following levels: ALT 1076 U/L, AST 653 U/L, TBil 43.1 μmol/L,and DBil 32.3 μmol/L. She was diagnosed with acute liver damage. Lomefloxacin was discontinued immediately and she was given drugs for liver protection treatment. Four days after discontinuation of the drug, the patient’s symptoms improved, but she presented with jaundiced sclera and skin. Repeat liver function tests revealed the following levels: ALT 731 U/L, AST 420 U/L,TBil 164.8 μmol/L, and DBil 122.9 μmol/L. Fourteen days later, her jaundice subsided and her liver function returned to normal range.
  • 安全信息
    . 2011, 13(4): 267-1.
  • 病例报告
    Zhao Yanxia
    . 2010, 12(5): 360-2.

    A 64yearold man received injections of botulinum toxin A at multiple points on his canthi and forehead in the treatment of wrinkles for a cosmetic purpose. Botulinum toxin A 2-5 U was injected into each point and the total dosage was < 50 U. One hour after injection, the patient developed dizziness, palpitation, facial swelling with flushing, difficulty in eye opening, abdominal pain, diarrhea, and mild dyspnea, with a temperature of 36.7 ℃, a respiratory rate of 20 breaths/min, a pulse of 56 beats/min, a BP of 120/75 mm Hg. The case was considered to be botulinum toxin Ainduced anaphylaxis, and dexamethasone, cimetidine, vitamin C, diphenhydramine and cetirizine were given immediately. One hour later, his facial swelling and dyspnea relieved, and abdominal pain and diarrhea disappeared. The next day, the patient received an IV infusion of dexamethasone again, and his condition improved further.

  • 病例报告
    Sun Suxin
    . 2011, 13(1): 47-1.
    A 76yearold male patient with erysipelas received an IV infusion of amoxicillin/sulbactam 2.25 g in 0.9% sodium chloride 100 ml twice daily and an IV infusion of 0.4% tinidazole 100 ml once daily. Six days later, his routine blood tests revealed the following results: WBC count 1.86×109/L with neutrophils 0.21, lymphocytes 0.55, and monocytes 0.23, and neutrophil count 039×109/L. Amoxicillin/sulbactam and tinidazole were withdrawn immediately and he received symptomatic treatment. Three days after drug discontinuation, routine blood tests showed a WBC count of 3.20×109/L with neutrophils 0.32, lymphocytes 0.54, and monocytes 0.12, and a neutrophil count of 1.04×109/L.
  • 病例报告
    Chen Huiyun
    . 2010, 12(6): 444-2.
    A 52yearold male patient selfmedicated with 2 bags of the compound paracetamol and chlorphenamine maleate granules (each bag contains paracetamol 250 mg, caffeine 15 mg, chlorphenamine maleate 3 mg, calculus bovis factitious 10 mg ) for a cold. Thirty minutes later, the patient developed palpitation, weakness, generalised tremor, and polyhidrosis. His heart rate was 192 beats/min and ECG showed supraventricular tachycardia. He then was given an IV push of propafenone 70 mg. About ten minutes later, the tremor stopped. His symptoms improved gradually and heart rate was 92 beats/min. He did not take compound paracetamol and chlorphenamine maleate granules any more at 3month followup, and the abovementioned symptoms did not recur.
  • . 2013, 15(6): 302-2.
  • 病例报告
    LI Xiao-yu;ZHANG Yun;LIU Yu-lan
    . 2012, 14(4): 263-4.
    A 78-year-old male patient with coronary atherosclerotic heart disease intermittently took pravastatin 20 mg once every night and aspirin 100 mg once daily for 4 years. Three months ago, the patient presented to hospital with paroxysmal precordial discomfort, palpitations, and shortness of breath, and he was diagnosed with “coronary heart disease”. The patient then began to regularly take the above-mentioned 2 drugs at the same dosage as before. Eleven weeks later, the patient developed generalized muscle pain, limb weakness, dark urine, and oliguria with no other apparent precipatating causes. One day before admission, when the patient defecated, he developed tight chest, palpitations, and shortness of breath, and these symptoms did not completely resolve despite rest. Biochemical blood tests revealed the following levels and values: aspartate aminotransferase (AST)294 U/L, alanine aminotransferase (ALT) 180 U/L, lactate dehydrogenase (LDH) 677 U/L, hydroxybutyrate dehydrogenase (α-HBDH) 720 U/L, creatine kinase (CK) 12 210 U/L, and creatine kinase isoenzyme (CK-MB) 770 U/L. Pravastatin was stopped and symptomatic treatments were given. The patient’s muscle pain relieved 3 days later, and disappeared 1 week later. Two weeks later, the biochemical blood tests showed the following results: AST 16 U/L, ALT 24U/L, LDH 192 U/L, α-HBDH 225 U/L, CK 72 U/L, and CK-MB 1.3 U/L. The patient’s symptoms did not recur, and his myocardial enzymes and liver enzymes were within normal ranges at a three-month follow-up.
  • 论著
    YIN Jing;YAN Sheng-li;ZHANG Hui;WANG Yong-yan;ZHANG Sha-sha
    . 2012, 14(4): 214-4.

    ObjectiveTo explore the relationship between the cytotoxic T lymphocyte-associated antigen 4 gene (CTLA-4) polymorphisms and the liver injury caused by methimazole (MMI) in the Chinese Han patients with Graves disease (GD) in Shandong district. Methods The subjects were selected from out- and in-patients with GD at the Department of Endocrinology (the GD group), and the healthy people receiving physical examination at the medical center (the healthy control group) in the Affiliated Hospital of Qingdao University from March 2011 to April 2012. The GD group comprised 3 subgroups: the simple GD group, the MMI-induced liver injury group, and the hyperthyroidism-related liver injury group. Clot of non-anticoagulated blood from a peripheral vein in each subject was collected, genomic DNA was extracted, and genotypes at position 49 in exon 1 and position -318 in promoter region of CTLA-4 gene were detected using polymerase chain reaction-restriction fragment length polymorphism. The genotype and allele frequencies in all groups were calculated. ResultsA total of 160 GD patients were collected. Of them, 65 patients were in the simple GD group, including 10 males and 55 females with an average age of (40.4±14.4) years; 40 patients in the MMI-induced liver injury group, including 11 males and 29 females with an average age of (40.5±13.7) years; 55 patients in the hyperthyroidism-related liver injury group, including 9 males and 46 females with an average age of (38.0±12.9) years. Sixty-four healthy people were in the healthy control group, including 20 males and 44 females with an average age of (40.7±10.7) years. The differences in gender and age among all groups were not statistically significant (P>0.05). The genotype frequencies of AG+GG at position 49 in exon 1 of CTLA-4 gene in the GD and the health control groups were 91.9%(147/160)and 78.1% (50/64), respectively; the allele frequencies of G were 74.4% (238/320) and 59.4% (76/128), respectively; the differences in the 2 groups were statistically significant (χ2=8.153,P=0.004; χ2=6.259,P=0.012). The genotype frequencies of CT+TT and the allele frequencies of T at position -318 in promoter region of CTLA-4 gene between the GD and the health control groups were not statistically significant (P>0.05 for all comparisons). The differences in the genotype frequencies of AG+GG and the allele frequencies of G at position 49 in exon 1 of CTLA-4 gene, the genotype frequencies of CT+TT and the allele frequencies of T at position -318 in promoter region of CTLA-4 gene among the 3 subgroups in the GD group were not statistically significant (P>0.05 for all comparisons). ConclusionIn Chinese Han patients with GD in Shandong district, the polymorphisms of CTLA-4 gene at position 49 in exon 1 and -318 promoter region are not significantly related to MMI-caused liver injury, and the polymorphism of A/G at position 49 in exon 1 might be related to the pathogenesis of GD.

  • 论著
    HUANG Jin;ZHANG Hua-feng;WU Lei;LIU Yang-yang;YE Yang-min
    . 2012, 14(2): 77-5.
    ObjectiveTo explore the effects of renal function on linezolid-induced thrombocytopenia in patients who receiving the drug in order to provide evidence for safe use of linezolid in patients with renal insufficiency. Methods The clinical data of patients with renal insufficiency or normal renal function and pulmonary infection cansed by Gram positive bacteria, who were treated with linezolid alone or combined with other drugs, and hospitalized in the Air-Force General Hospital during the period from January 2008 to May 2011, were collected and analyzed retrospectively. The main observational indices such as platelet count, serum creatinine and urea nitrogen levels were measured before and after drug application. According to the principle of proprer matching in age and duration of hospitalization, some infection patients with normal renal function, who were hospitalized during the same time period and treated without linezolid, but with a antibacterial drug of the combined linezolid therapy, were selected as controls in order to exclude the influence due to drug combination. ResultsA total of 43 patients received linezolid, the patients with renal insufficiency (the renal insufficiency group, 22 cases) comprised 15 male and 7 female aged 38-93 (74.8±14.2) years, 16 patients were treated with combined use of linezolid and other kinds of antibacterial agents, including teicoplanin (1 case), meropenem (4 cases), vancomycin (1 case), metronidazole (1 case), imipenem (6 cases), and cefoperazone/sulbactam (3 cases). The patients with normal renal function (normal renal function group, 21 cases) included 17 male and 4 females aged 38-90 (73.8±13.7) years. The patient’s number in each group of teicoplanin, meropenem, vancomycin, metronidazole, imipenem and cefoperazone/sulbactam was 22 cases. The duration of linezolid therapy was 1-13 (5.4±3.6) days in the renal insufficiency group, and 2-13 (5.9±3.0) days in the normal renal function group. The platelet count in the renal insufficiency group before and after receiving linezolid were (207±94)×109/L and (131±97)×109/L, respectively. The difference was statistically significance (P<0.01). The platelet count in the normal renal function group before and after receiving linezolid was (208±89)×109/L and (181±94)×109/L, respectively (P>0.05). The incidence of thrombocytopenia in the renal insufficiency and normal renal function groups was 59.1% (13/22) and 28.6% (6/21), respectively. The difference was statistically significant (P<0.05). There were no symptoms of hemorrhage in patients with thrombocytopenia in the 2 groups. The platelet count gradually returned to baseline 3-10 (5.7±3.3) days after drug withdraw. The patients in the renal insufficiency group, who received combination therapy with metronidazole (1 case), vancomycin (1 case), and teicoplanin (1 case) developed thrombocytopenia. Three cases developed thrombocytopenia in 4 patients who were treated with combined use of linezolid and meropenem; 2 cases developed thrombocytopenia in 3 patients who were treated with combined use of linezolid and cefoperazone/sulbactam; 3 of 6 patients who were treated with combined use of linezolid and imipenem developed thrombocytopenia. There were no statistically significance in platelet count before and after medication among teicoplanin, meropenem, vancomycin, metronidazole, imipenem, and cefoperazone/sulbactam groups (P>0.05 for all comparisons). Only one patient developed thrombocytopenia (mild) in the cefoperazone/sulbactam group. The differences in incidence of thrombocytopenia between the patients who were treated with combined use of linezolid and one of the 6 antibacterial agents mentioned above in the renal insufficiency group and the patients who received one of 6 antibacterial agents alone in the other groups were statistically significance (P<0.05 for all comparisons). ConclusionThe patient’s renal function may affect the incidence of linezolid-induced thrombocytopenia. The platelet count in patient with renal insufficiency should be monitored regularly when receiving linezolid. If thrombocytopenia occurs, the drug should be discontinued immediately.
  • 病例报告
    GAO Zhi-qiang
    . 2012, 14(1): 56-2.

    A 57-year-old female with lung cancer received an IV infusion of fat-soluble vitamin (Ⅱ) for injection 10 ml dissolved in 250 ml of 0.9% sodium chloride injection at a rate of 60 drops/min. One minute after intravenous drip of the fat-soluble vitamin (Ⅱ) for injection, the patient developed a feeling of numbness, convulsion, unconsciousness, generalized redness, and lip cyanosis. The fat-soluble vitamin (Ⅱ) for injection was discontinued immediately, adrenaline 0.5 mg and dexamethasone 10 mg and dopamine 40 mg were given by IV bolus, and nasal cannula oxygen inhalation was given. After five minutes the patient’s consciousness was restored. ECG monitoring revealed a heart rate of 127 beats/min and an blood oxygen saturation was 0.85, her blood pressure was undetectable. Dopamine 200 mg dissolved in 50 ml of 0.9% sodium chloride injection and adrenaline 2 mg dissolved in 50 ml of 0.9% sodium chloride injection were given via IV pump, and 500 ml of 0.9% sodium chloride injection and dextran 40 injection 500 ml were given by intravenous drip. Two hours later, her blood pressure was 80/50 mm Hg. Three hours later, the blood pressure increased to 130/70 mm Hg and the blood oxygen saturation increased to 0.98, her anaphylactic symptoms disappeared.

  • 病例报告
    . 1999, 1(3): 180-180.
  • ADE简报
    . 1999, 1(3): 192-192.
  • 病例报告
    . 2002, 4(6): 407-407.
  • 不良事件
    . 2005, 7(1): 40-40.
  • 病例报告
    . 2003, 5(5): 333-334.
  • 病例报告
    . 2000, 2(2): 128-128.
  • 不良事件
    . 2004, 6(3): 198-198.
  • 中毒救治
    . 2005, 7(4): 278-278.
  • 病例报告
    . 2005, 7(3): 211-212.
  • 不良事件
    . 2005, 7(2): 149-149.
  • 不良事件
    . 2005, 7(1): 68-68.
  • 不良事件
    . 2002, 4(1): 13-13.
  • 病例报告
    . 2004, 6(2): 123-123.
  • 安全信息
    . 2006, 8(5): 395-395.
  • 中毒救治
    . 2006, 8(6): 437-438.
    过氧乙酸广泛用于医学消毒,有较强的刺激性和腐蚀性。自2003年SARS流行后,口服过氧乙酸急性中毒患者明显增多,中毒后可造成食道、胃等消化道黏膜灼伤、出血、穿孔、急性腹膜炎、多脏器功能衰竭。总结我科收治3例口服过氧乙酸急性中毒后患者的临床资料,探讨临床紧急救治措施及预后,对合并食道严重狭窄者可行食道扩张术和放置食道支架。
  • 病例报告
    . 2003, 5(2): 114-114.
  • 病例报告
    . 2002, 4(1): 47-48.
  • 病例报告
    . 2004, 6(4): 255-256.
  • Yang Chunyan, Song Jing, Liu Jun, Luan Jiajie
    Adverse Drug Reactions Journal. 2022, 24(5): 268-270. https://doi.org/10.3760/cma.j.cn114015-20210913-00988
    An 87-year-old female patient with advanced lung adenocarcinoma received an IV infusion of camrelizumab 200-mg once every three weeks. The patient developed hyperthyroidism before the 5th treatment, subclinical hypothyroidism before the 6th treatment, and clinical hypothyroidism before the 7th treatment. No other drugs were used during the treatment of camrelizumab, which was considered to be immune thyroid disfunction caused by camrelizumab. Levothyroxine sodium replacement therapy was given. The patients were followed up until the 13th treatment was finished. Except for the occasional high thyroid stimulating hormone, the other indexes were within the reference value range, and the symptoms of abdominal distension, anorexia, chills, and fatigue were basically relieved.
  • 不良事件
    . 2004, 6(4): 270-270.
  • 病例报告
    . 2003, 5(6): 395-395.
  • 病例报告
    . 2004, 6(6): 408-408.
    A 55-year-old man was hosipitalized with hypertension, diabetes and hyperlipemia. He had no history of drug hypersensitivity in the past. The patient was treated with intravenous infusion of sodium ferulate 0.15g. 5 minutes later, he suddenly developed restless, sweat, paleness, cold limbs, diminished heart sounds and undetected BP, which was considered in association with allergy of sodium ferulate. The liquid was withdrawn immediately and his BP was raised to 110-130/60-80mmHg after receiving dopamine 20mg, dexamethasone 10mg and adrenaline 1mg.
  • WHO信息
    . 2001, 3(4): 268-268.
  • 病例报告
    . 2001, 3(1): 42-43.
  • WHO信息
    . 2003, 5(1): 62-62.
  • 病例报告
    . 2004, 6(3): 180-181.
  • ADE简报
    . 2000, 2(2): 132-132.
  • 不良事件
    . 2003, 5(5): 325-325.
  • 病例报告
    . 2004, 6(1): 41-42.
  • Dang Yanli;Zhang Wenying;Du Jianxin;Lu Yeyan;Liu Yinlan
    Adverse Drug Reactions Journal. 2010, 12(2): 140-2.
    A 70yearold woman received an IV infusion of paclitaxel 210 mg in 0.9% sodium chloride 500 ml for chemotherapy 21 days after ovarian cancer operation. Five minutes later, the patient developed chest distress and generalized acanthesthesia, and then unconsciousness, pallor, clamminess in her extremities, dyspnea occurred. Meanwhile her blood pressure was 80/62 mm Hg and heart rate was 100 beats/min. Paclitaxel was discontinued immediately and dexamethasone and promethazine hydrochloride were given. Ten minutes later, her symptoms relieved. Subsequently, anaphylactic reactions did not recur after reexposure to a low concentration paclitaxel infusion at a slow rate.
  • 病例报告
    Zhu Yuxia;Chang Junlan;Yue Ling
    . 2010, 12(3): 165-2.

    A 40-year-old man took ciprofloxacin 0.2 g by himself for upper respiratory infections. Two hours later, he developed gross hematuria. Ciprofloxacin was stopped, and gross hematuria disapperaed after two days, then microscopic hematuria subsided after one months. Gross hematuria reccured after readministration of ciprofloxacin 0.2 g by himself, and vanished after the drug discontinuation.

  • 病例报告
    TAN Bing;CHEN Xia;ZHU Shen-yin
    . 2012, 14(6): 386-2.
    A 24-year-old male patient developed nausea, vomiting and abdominal pain after receiving 2 tablets of compound paracetamol (each tablet containing paracetamol 126 mg, aspirin 230 mg, and caffeine 30 mg) for headache and low-grade fever. Laboratory examination showed the following results: blood urea nitrogen 10.80 mmol/L, serum creatinine 360 μmol/L and blood uric acid 523.7 μmol/L. Symptomatic treatments such as fluid infusion and diuretics were given. Five days later, his renal function returned to normal.
  • XIA Zong-ling;HAN Xue-cheng;ZOU Ying
    A 75-year-old female patient received oral metoprolol (100 mg every morning and 75 mg every night) and rivaroxaban (20 mg every night) for hypertension and atrial fibrillation following the advice of doctor in hospital. One month later, liver function tests showed an alanine aminotransferase(ALT) value of 90 U/L and gamma-glutamyl transpeptidase(γ-GT) value of 133 U/L and the patient developed blurred vision. Rivaroxaban was stopped and, on the next day, her blurred vision disappeared. On day 3, the levels of ALT and γ-GT were 49 U/L and 73 U/L, respectively. On the second day after stopping rivaroxaban, oral warfarin 3 mg every night was given. The next day, the patient presented with hematuria and an emergency test showed an INR level of 0.98. The patient refused to continue using warfarin. Then she took reduced-dose rivaroxaban (10 mg every night and providing for herself) again and the liver function and ocular symptoms were monitored closely. Henceforth, the levels of ALT and γ-GT were normal basically and blurred vision did not recur.
  • LIU Chen;WANG Yu-qin;SHEN Qian;LI Xiao-ling;JIANG De-chun;LI Xing-wei.
    ObjectiveTo analyze the clinical manifestations of severe adverse reactions induced by cisplatin in cancer patients and discuss the influencing factors.MethodsThe reports of severe adverse reactions induced by cisplatin in National Center for ADR Monitoring from January 1, 2009 to December 31, 2010 were collected and analyzed retrospectively. The patients were divided into two groups: elderly group (≥60 years old) and non-elderly group (18-59 years old). The gender and age distribution, tumor location, appearance time for severe adverse reactions after treatment, clinical manifestation, cisplatin′s formulation and dosage, drug combination, and patients′outcome were compared between the two groups. The elderly group was further divided into two subgroups, 60-69 years old and 70-79 years old. Subgroup analysis of statistically significant factors were conducted.ResultsA total of 228 reports of severe adverse reaction induced by cisplatin including 228 patients were collected. There were 103 patients in the elderly group comprising 72(69.9%) males and 31(30.1%) females with an average age of (67±5)years. There were 125 patients in the non-elderly group comprising 59(47.2%) males and 66(52.8%) females with an average age of (48±9)years. Percentage of male in the elderly group was higher than that in the non-elderly group(χ2=11.907, P=0.001). The proportion of respiratory system tumor was the leading ones in the list in both groups. The proportion of respiratory system tumor in the elderly group was higher than that in the non-elderly group (χ2=8.512, P=0.004). The proportion of urogenital tumor in the elderly group was lower than that in the non-elderly group (χ2=8.759, P=0.003). The difference of appearance time for serious adverse reactions after treatment between the 2 groups was statistically significant(χ2=-2.545, P=0.011). There was no statistically significant difference in applying cisplatin powder or cisplatin solution for injection between the 2 groups. The doses of cisplatin were 10-140 mg/d and 10-420 mg/d in the elderly group and the non-elderly group, respectively. The difference was statistically significant(P=0.011). In the elderly group cisplatin was combined with gemcitabine, etoposide, and docetaxel, the median number of drug combination was 0 (interquartile:0-1). In the non-elderly group cisplatin was combined with paclitaxel, gemcitabine, and docetaxel, the median number of drug combination was 1 (interquartile:1-1), the difference was statistically significant (P=0.032). The main severe adverse reactions induced by cisplatin were myelosuppression and leukopenia. The number of cases who developed myelosuppression and leucopenia was 50(48.5%) and 24(23.3%), 69(55.2%) and 24(19.2%) in the elderly and non-elderly groups, respectively. The differences were no statistically significant. Two patients in the elderly group developed renal impairment. There was no report of renal impairment in the non-elderly group. Two patients in the non-elderly group developed QT prolongation. There was no report of QT prolongation in the elderly group. After discontinuation and symptomatic treatment, the number of cases with recovery, improvement, sequelae, and death in the elderly group were 27(26.2%), 72(69.9%), 3(2.9%), and 1(1.0%), respectively, and in the non-elderly group were 38(30.4%), 83(66.4%), 3(2.4%), and 1(0.8%), respectively. The differences were not statistically significant. Percentage of male in the subgroup of 70-79 years old (87.1%) was higher than that in the subgroup of 60-69 years old (62.5%)(χ2=6.232, P=0.013). Differences in dosage and number of drug combination were not statistically significant between the 2 subgroups.ConclusionsThe severe adverse reactions induced by cisplatin were similar in the elderly group and the non-elderly group. The elderly male, especially aged 70 to 79 years, were the high risk group of severe adverse reactions induced by cisplatin.
  • 病例报告
    Chen Yue;Xie Liya
    . 2011, 13(5): 317-1.

    A 56-day-old male infant was hospitalized with thrombocytopenic purpura. Two days before admission, his mother underwent tubal ligation surgery and received oral amoxicillin to prevent infections after surgery. Breast-feeding was not stopped during the period of drug use. On day 2 of drug therapy, the infant developed scattered pin-sized red spots on his lower leg skin and, on day 3, petechia appeared on his lower left leg. On admission, his PLT level was 4×109/L, thrombocytopenic purpura was confirmed by bone marrow cytological analysis. Breast-feeding was stopped and the infant was given supportive treatments. Two weeks later, he recovered and was discharged.

  • 病例报告
    Yue Huijie;Song Xiaojun;Leng Jing;Ni Jianghong
    . 2011, 13(6): 389-2.
    A 68-year-old male patient received aspirin 0.1 g once daily, clopidogrel 75 mg once daily, amlodipine 5 mg once daily, and rosuvastatin 10 mg once at night orally, and was intravenously infused with edaravone 30 mg twice daily, Shuxuening 20 ml once daily, and oxiracetam 4 g once daily for multiple cerebral infarction, primary hypertension and diabetes. Six days later, the patient underwent cerebral angiography and stent implantation to his right carotid artery sinus. On the day of surgery, he suddenly presented with weakness of his left limbs. Subsequently, he gradually developed tingling chest pain and decreased urine volume. The peak values of creatine kinase and myoglobin were 2754 U/L and 10 999 μg/L, respectively. Rosuvastatin-induced rhabdomyolysis was diagnosed. Rosuvastatin was withdrawn and other medications were continued. Meanwhile, continuous renal replacement therapy, anti-infective therapy, fluid supplementation and other symptomatic treatment were given. The patient’s condition gradually improved.
  • Lu Meihua
    . 2016, 18(6): 459.
    A 75-year-old man with symptoms of fever, frequent and urgent urination, backache, muscle aches, and fatigue was diagnosed as urinary track infection. The results of  laboratory test reported three days after the diagnosis showed the following volumes: (CK) 14 190 U/L, CK-MB 204 U/L. He was diagnosed as rhabdomyolysis. The patient had been regularly taking atorvastatin (20 mg/d) for over 10 years due to his hyperlipidemia, atherosclerosis, and coronary heart disease. The rhabdomyolysis was considered to be related to long-term use of atorvastatin complicated with urinary tract infection. Atorvastatin was discontinued  immediately and the treatments including anti-infection, fluid infusion, and correction of electrolyte imbalance were given. Seven days after the treatments, the patient′s symptoms of  urinary track infection were disappeared and he had no any complaints. The results of  laboratory test showed CK 472 U/L,CK-MB 4 U/L, and the urine routine examination showed no abnormal results. The results of follow-up about one month later showed CK 52 U/L,CK-MB 5 U/L.
  • Yang Zhiyun, Li Shanshan, Chen Jie, Chen Xiao
    . 2017, 19(2): 96-102.
    ObjectiveTo establish a regression model for predicting the resistance rate of Acinetobacter baumannii (Ab) to anti-bacterial agents.MethodsThe monitoring data of resistance rate of 1 249 Ab strains to 10 frequently used anti-bacterial agents and drug consumption data [the main indicators for the frequency of medication (DDDs) and antimicrobial use intensity (AUD)] of these agents from January 2014 to December 2016 in the First Affiliated Hospital of Sun Yat-sen University were collected. Pearson correlation analysis was performed to analyze the correlation between Ab resistance and AUD. A linear regression model was established for the anti-bacterial agents with correlation between drug resistance and AUD. Then the regression model was used to predict the resistance rate of Ab in January 2017 and February 2017.ResultsDuring the 3 years from 2014 to 2016, the resistance rate of Ab to tigecycline was the lowest (<7% for the 3 years), the resistance rate of Ab to ciprofloxacin was the highest (the average resistance rate was 82.1% for 3 years), there were 3 kinds of drugs whose average resistance rates were <70% and 7 kinds of drugs whose average resistance rates were >70% during the 3 years. The AUD of cefoperazone sodium sulbactam sodium, levofloxacin, tigecycline, panipenem/betamipron, and cefepime were increased. Pearson correlation analysis showed that the resistance rates of Ab to cefoperazone sodium sulbactam sodium and levofloxacin were correlated with their AUD (r=0.681, P=0.015; r=0.694, P=0.012). The data related to Ab resistance rates and AUD of cefoperazone sodium sulbactam sodium and levofloxacin were brought into the one variable linear regression equation. The variance analysis showed that the 2 regression equations fitted well(F=8.634, P= 0.015; F=9.285, P=0.012). The AUD of cefoperazone sodium sulbactam sodium and levofloxacin in January and February, 2017 were respectively brought into the regression equation and the resistance rates of Ab were predicted. The results showed that the actual resistance rates were evenly distributed around the predictive values and within 95% of the predicted range.ConclusionIn our hospital, AUD of cefoperazone sodium sulbactam sodium and levofloxacin were related to resistance rates of Ab and the linear regression model could predict the resistance rate of Ab by AUD.
  • Zhang Ninggang, Wang Yusheng, Li Xiuxiu, Song Xuefeng, Wen Lu
    . 2017, 19(5): 346.
    ObjectiveTo summarize the situations and characteristics of adverse drug reactions (ADR) of bevacizumab (Bev) combined with chemotherapy in treatment of advanced colorectal cancer.MethodsThe medical data of the patients with advanced colorectal cancer who received Bev combined with chemotherapy in Shanxi Tumor Hospital from April 2010 to December 2016 were collected for retrospective analysis. The sexual distinction, age, therapeutic regimen, time of using Bev, types and grades of adverse reactions which were related to chemotherapy and Bev respectively, the time from medication to appearance of ADR, and the patients′ outcomes were comparied.ResultsA total of 83 patients were enrolled in the study. Of them, 39 were males and 44 were females. Fifty-eight cases were <65 years old, 25 cases were ≥65 years old. There were 43 patients with colon cancer and 40 patients with rectal cancer. Forty-five patients received the treatment  with Bev combined with first-line chemotherapy, and the number of cases who received mFOLFOX, FOLFIRI and fluorouracil were 18, 22 and 5, respectively. Thirty-eight patients received the treatment with Bev combined with second-line chemotherapy, and the number of cases receiving mFOLFOX, FOLFIRI and fluorouracil were 9, 19 and 10, respectively. Of 83 patients, 71 patients developed totally 152 case-times ADRs which were related to chemotherapy drugs, among them 31 patients developed 31 case-times ADRs related to Bev. The incidences of ADRs associated with chemotherapy drugs and Bev were 85.5% and 37.3%, respectively. The forenamed proportions were 83.1% (152/183) and 16.9% (31/183) respectively in the total case-times of ADRs. The top five incidences of ADRs associated with chemotherapy drugs were bone marrow suppression (59.0%, 49/83), nausea and vomiting (51.8%, 43/83), fatigue (19.3%, 16/83), peripheral neuritis (15.7%, 13/83) and abnormal liver function (10.8%, 9/83), successively. The proportions of levels of I, II, III and IV of ADRs were 28.2% (20/71), 36.6% (26/71), 23.9% (17/71) and 11.3% (8/71), respectively. The highest incidence of ADRs associated with Bev was hypertension (13.3%, 11/83), after that the incidences were hemorrhage (12.0%, 10/83), thrombosis (6.0%, 5/83),  intestinal perforation (2.4%, 2/83), proteinuria (2.4%, 2/83) and wound healing syndrome (1.2%, 1/83), successively. The proportions of levels of Ⅰ, Ⅱ, Ⅲ and Ⅳ of ADR were 58.1% (18/31), 19.4% (6/31), 16.1% (5/31) and 6.5% (2/31), respectively. The ADRs related to the chemotherapy drugs appeared on day 1-115 after medications, the proportion of less than or equal to 3 months were 73.2% (52/71). The ADRs related to Bev appeared on day 5-130 after medications, the proportion of less than or equal to 3 months were 87.1% (27/31). The results of stratification analysis of gender, age (<65 years old and ≥65 years old), using time (first-line or second-line chemotherapy), cumulant of Bev (≤6 periods and >6 periods), and combined with different chemotherapy regimens (mFOLFOX, FOLFIRI and fluorouracil) showed that there were no significant differences between the incidences of ADRs related to chemotherapeutic drugs and Bev among the groups of different clinical features. The proportion of levels III and IV ADRs related to chemotherapeutic drugs were higher than those of Bev combining with single drug regimen of 5-FU (P<0.05). There were no significant differences in ADR level distributions of chemotherapeutic drugs and Bev in other clinical features groups (all P>0.05).ConclusionsThe main ADRs caused by Bev combined with different chemotherapies in treatment of advanced colorectal cancer are ADR related to chemotherapeutic drugs. The ADRs associated with chemotherapeutic drugs and Bev are level Ⅰ-Ⅱ mainly and had better safety.
  • Lyu Weiling, Zhang Jinping
    . 2016, 18(6): 467.
    A 75-year-old male patient self-medicated with 1 to 1.5 patches of transdermal fentanyl patches (4.2 mg-6.3 mg) for abdominal pain of postoperative gastric cancer about half a month. In recent half a month, he gradually developed somnolence and fatigue. At night before the day the patient was admitted, he received 1.5 patches of transdermal fentanyl patches before sleep for severe abdomen pain. On the second day morning, the patient′s family members found that he developed coma and had no response to voice stimuli. Then he was admitted to emergency department. After cerebrovascular accident was excluded, treatments such as oxygen inhalation and improving blood flow etc. were given. Two days later, the patient regained consciousness gradually (the transdermal fentanyl patch before admission was removed after 72 h of treatment). The patient received another patch of transdermal fentanyl patch for abdominal pain again following the doctor′s advice and 3 h later, coma recurred. It was considered that coma was induced by transdermal fentanyl patches. The transdermal fentanyl patch was removed immediately and oxygen inhalation, IV infusion of naloxone were given. Two hours later, he regained consciousness.
  • Wang Min, Zhang Liming, Han Qiang
    . 2016, 18(3): 236.
    A 56-year-old male patient with heart failure, atrial fibrillation and hyperthyroidism required hospitalization as a result of acute exacerbation of heart failure. The ventricular rate of the patient was 186 beats/min when he came to the hospital. He received an IV bolus of amiodarone 150 mg and an intravenous infusion of 300 mg for correction of and keeping his ventricular rate. He was given another 300 mg amiodarone later that day. The next day, he became unconscious. Electrocardiographic monitoring showed that his ventricular rate was 92 beats/min, QT interval was 0.40 s on average, premature ventricular beats were frequent, ventricular rate became 256 beats/min, then torsades de Pointes ventricular tachycardia and ventricular fibrillation appeared alternately. Heart rate was turned into ventricular tachycardia after heart thump and electric defibrillation. He was given an IV bolus of lidocaine 50 mg, his heart rate turned into rapid atrial fibrillation and ventricular rate was 140 beats/min. Biochemical examination of the patient showed that potassium concentration was 3.1 mmol/L. An intravenous infusion of 10% potassium chloride 10 ml plus compound balance fluid was given, and amiodarone was stopped. Electrocardiographic monitoring showed no obvious abnormality.
  • Xu Yong, Li Zhiliang, Feng Jihong, Nie Zhenwang
    . 2017, 19(6): 461.
    A 63-year-old female patient received oral adefovir dipivoxil 10 mg once daily for chronic hepatitis B. She developed right knee and left shoulder pain at the 7th year of the treatment, followed by right hip pain and bilateral pain in the ribs, hips, knees and heels. Osteodynia progressed to the lower back and weakness and limited mobility in the 8th year. Laboratory tests showed the following values: serum phosphorus 0.48 mmol/L, calcium 2.28 mmol/L, uric acid 77 μmol/L, urine glucose (+), urinary protein (++), urinary occult blood test (+), urinary β2-microglobulin 2.5 mg/L. Bone mineral density examination revealed osteopenia. Pelvic X-ray examination showed the osteoporosis of the hip and right femoral neck fracture. The patient was diagnosed as adefovir dipivoxil-induced Fanconi syndrome and pathological femoral neck fracture. Adefovir dipivoxil was stopped and her therapy was changed to entecavir 0.5 mg once daily. She was given IV infusion of fructose diphosphate 10 g once daily and 5% sodium bicarbonate injection 125 ml  once daily, oral calcium carbonate 1 500 mg once daily and alfacalcidol soft capsules 0.25 μg thrice daily. One week later, the right femoral head replacement combined with the right femoral shaft fracture plate fixation was performed. The above-mentioned drugs were continued. After 5 weeks of adefovir dipivoxil discontinuation, serum phosphorus was 0.72 mmol/L, uric acid was 136 μmol/L, urinary protein (+) and the osteodynia was significantly alleviated. After 5 months of adefovir dipivoxil withdrawal, laboratory tests showed the following values: serum phosphate 0.87 mmol/L, uric acid 215 μmol/L, urine glucose (-), urinary protein (-). Four months later, the serum phosphate was 1.02 mmol/L, the patient could walk normally.
  • Li Li, Shi Rui, Lu Shan, Pan Dan
    . 2017, 19(6): 473.
    A 29-year-old female patient with hyperthyroidism received methimazole 20 mg once daily according to the doctor′s advice. Her liver function was normal before drug administration. Fourteen days after medication, the results of laboratory test showed that ALT was 122 U/L, AST 87 U/L. Methimazole was stopped and liver protection treatment was given. Nine days later, her ALT and AST were 42 U/L and 35 U/L, respectively. She received methimazole 10 mg once daily again. On day 9 of remedication, the patient developed rash with pruritus, pain and limitation of activity on the right elbow joint, pain on the bilateral shoulder joints and the knee joints, and laboratory test showed ALT 134 U/L, and AST 109 U/L. She was diagnosed as drug induced liver injury, drug rash, and drug related arthritis syndrome. Methimazole was stopped again. The patient received the treatments of antianaphylaxis, liver protection and analgesic. Ten days later, her rash mostly disappeared. Laboratory test showed ALT 36 U/L and AST 24 U/L. Her arthralgia was improved slightly, could move intentionally, but activity was limitated occasionally.
  • 论著
    Li Bing;Xue Jixiu;Xu Guoxun;Liu Qinghai;Wang Tianlong
    . 2011, 13(6): 348-6.

    Objective: To explore the effects of ephedrine on depth of sedation with propofol in patients receiving general anesthesia in order to benefit the rational use of ephedrine. Methods: The patients, who were in ASA physical status Ⅰ to Ⅱ with age of 18 years or older, scheduled to undergo non-neurological surgery under general anesthesia with propofol, were enrolled in this study. Propofol was administered by target-controlled infusion (TCI). Ephedrine 0.15 mg/kg was administrated by IV infusion within 20-30 s after blood pressure dropped, the observer’s assessment of alertness/sedation scale (OAA/S) was 2, and bispectral index (BIS) stabilized for 5 minutes. The heart rate (HR), SpO2, mean arterial pressure (MAP) of right radial artery, BIS and OAA/S were recorded at different time points before and after starting an IV infusion of ephedrine. Results: Eight patients [3 males and 5 females with average age of (50±2) years, BMI (25.1±3.7) kg/m2] were eligible for enrollment. Of them, 5 patients were scheduled to undergo laparoscopic for cholecystectomy and 3 patients to undergo endoscopic paranasal sinus surgery. The patients’HR and MAP were (81.1±3.0) beats/min and (93.3±6.4) mm Hg 2 minutes before administration of propofol by TCI, respectively, and decreased to (60.2±0.9) beats/min and (72.3±5.6) mm Hg (13.7±2.3)minutes after initiation of propofol, respectively; the differences were statistically significant (P<0.01 for all comparisons). The SpO2 was (98.1±1.5)% and (97.8±2.4)% before and after administration of propofol, respectively; the difference was not significant (P>0.05). The MAP was (81.2±6.0) mm Hg 2 minutes before receiving an IV infusion of ephedrine and increased to (87.0±6.5) and (92.6±7.4) mm Hg within 1-2 and 3-4 minutes after starting an IV infusion of ephedrine, respectively; the differences were statistically significant ( P<0.05 for all the comparisons). The BIS was (68.9±2.1) 2 minutes before receiving an IV infusion of ephedrine, and increased to (73.6±2.9), (77.7±3.1) and (79.5±3.0) within 5-6, 7-8 and 9-10 minutes after starting an IV infusion of ephedrine, respectively; the differences were statistically significant (P<0.05, P<0.01, P<0.01, respectively). The OAA/S score was (2.0±0.0) 2 minutes before receiving an IV infusion of ephedrine and increased to (3.5±0.3) 10 minutes after starting an IV infusion of ephedrine; the difference was statistically significant (P<0.05). The BIS, reaching its peak level, was delayed 2-4 minutes, in comparison with MAP. Conclusion: The depth of ropofol-induced sedation may decrease by an IV infusion of ephedrine during general anesthesia with propofol. Therefore, effective measures should be used according to the type of surgery and the patient’s condition for maintaining the depth of sedation and anesthesia within 2-4 minutes after starting an IV infusion of ephedrine.

  • 中药不良反应
    Su Zhijian;Wang Yunsu;Shu Wenlin
    . 2011, 13(6): 394-2.
    A 69-year-old man received Shenmai injection for his coronary atherosclerotic heart disease and arrhythmia. After the improvement of symptoms, Shenmai injection was stopped and switched to an IV infusion of Shenfu injection 60 ml mixed with 5% glucose 100 ml once daily. On the second day, the patient developed palpitations, chest distress, sweating, and inability to sleep at night. Electrocardiographic telemetry monitoring showed that the longest R-R interval reached 8.0 s which was considered to be associated with Shenfu injection. Shenfu injection was stopped and his therapy was changed back to Shenmai injection. Two days later, his R-R interval decreased to 1.2 s.
  • 专家论坛
    . 2012, 14(1): 4-4.
  • 病例报告
    Gao Xihua
    . 2011, 13(3): 200-1.
    A 55-year-old male patient with accelerated phase of chronic granulocytic leukemia received dasatinib 70 mg twice daily due to poor control with nilotinib therapy. On the day of drug administration, the patient developed diarrhea with frequent watery stools. Dasatinib was withdrawn, smectite powder was given, and then his diarrhea improved. Three days later, diarrhea recurred after readministration of dasatinib. And the symptoms of diarrhea subsided after discontinuation of dasatinib.
  • 病例报告
    Hu Yunzhen;Lu Xiaoyang
    . 2011, 13(3): 183-2.
    A 65-year-old man with type 2 diabetes mellitus was hospitalized with slow response to stimuli and slurred speech. Cranial magnetic resonance imaging showed cerebral infarction (acute phase). He was treated with enteric-coated aspirin 0.1 g once daily, edaravone 30 mg once daily, methylcobalamin, etc. He received the contrast medium iopromide 100 ml (equivalent to 30 g iodine) once daily for two days for undergoing contrast-enhanced CT scans of lung and abdomen. On day 3, he developed lower extremity edema, his 24 hour urine volume was 400 ml and then anuria occurred. An IV push of furosemide was given, but his symptoms did not improve. A repeat test showed a serum creatinine level of 475 μmol/L and a serum urea nitrogen level of 24.5 mmol/L. Acute renal failure was diagnosed and considered to be related to iopromide. After five days of continuous hemodialysis, the patient’s urine output increased and his serum creatinine level decreased to 284 μmol/L. Seventeen days later, his serum creatinine level dropped to 231 μmol/L and his serum urea nitrogen level was 14.4 mmol/L. Lower extremity edema significantly improved, and then he was discharged.
  • 病例报告
    Chen Xinzheng;Li Xia
    . 2011, 13(1): 51-2.
    Two men with chronic hepatitis B, aged 32 and 43 years, developed tubular injury and decreased serum phosphorus level after receiving oral adefovir dipivoxil 10 mg once daily. In patient 1, the laboratory tests revealed the following values: SCr 158 μmol/L,BUN 4.04 mmol/L,serum phosphorus 0.67 mmol/L, and creatinine clearance rate 47.6 ml/min 236 weeks after the start of treatment. And in patient 2, the laboratory tests showed the following levels: SCr 141 μmol/L,BUN 6.59 mmol/L,serum phosphorus 0.68 mmol/L, and creatinine clearance rate 48.7 ml/min 65 weeks after the start of treatment. However, their routine urine tests and urinary volumes were within normal range, and there was no generalized edema. The dosage regimen of adefovir dipivoxil was changed to 10 mg once every other day according to the creatinine clearance rate. Twelve weeks later, their SCr and BUN values decreased or returned to normal.
  • 病例报告
    CHU Miao;XU Zhi-hong;JIANG Qing
    . 2012, 14(1): 47-2.

    A 57-year-old female patient underwent total hip arthroplasty for left femoral neck fracture. On day 17 after surgery, the patient developed fever and, on day 20, her blood culture was positive for Staphylococcus warneri. She was prescribed an IV infusion of teicoplanin 0.4 g dissolved in 100 ml of 0.9% sodium chloride solution every twelve hours and oral ceftizoxime 2.0 g twice daily. On day 4, she presented with ecchymosis on her bilateral calves and her platelet count decreased from 249×109/L to 25×109/L. Teicoplanin was stopped and ceftizoxime was continued. On day 7, the platelet count returned to 104×109/L and her ecchymosis subsided basically.

  • 病例报告
    Sun Mu
    . 2010, 12(2): 139-2.
    A 70yearold woman was hospitalized for coronary heart disease, heart failure, and pulmonary infections. On admission, the patient received an IV infusion of milrinone 5 mg dissolved in 0.9% sodium chloride 30 ml via pump at a rate of 8 ml/h. About 30 minutes later, she experienced palpitation and chest distress. Physical examination showed a pulse of 128 beats/min, a heart rate of 135 beats/min, arrhythmia, and pulse deficit. ECG electrocardiogram revealed atrial fibrillation. Milrinone was stopped immediately and an IV push of amiodarone was given. One hour later, her symptoms subsided. Electrocardiogram monitoring revealed that the cardiac rhythm had turned to sinus rhythm, and her heart rates were 80 beats/min.
  • 不良事件
    . 2002, 4(2): 128-128.
  • 病例报告
    . 2005, 7(3): 164-164.
  • 不良事件
    . 2005, 7(2): 145-145.
  • 不良事件
    . 2003, 5(5): 349-349.
  • 不良事件
    . 2004, 6(2): 131-131.
  • ADR术语
    . 2004, 6(2): 140-140.
  • 中毒救治
    . 2002, 4(5): 319-320.
  • WHO信息
    . 2002, 4(2): 137-137.
  • 病例报告
    Wang Linghang
    . 2009, 11(3): 173-2.
    A 7-month-old male infant was hospitalized with hand, foot and mouth disease. Nystatin one million units dissolved in 10 ml of 0.9% sodium chloride injection was applied to the oral mucosa of the infant for complication of mycotic stomatitis. Meanwhile, an IV infusion of Tanreqing injection was given. Subsequently, the infant presented with crying and noise, convulsion of extremities, skin cyanosis, and high fever; his BP was 80/55 mm Hg and his heart rate was 160 beats/min. His symptoms relieved after treatment with anti-allergic drugs. Two days later, Tanreqing injection was withdrawn and nystatin was continued. Cyanosis and peripheral coldness recurred; his BP was 70/50 mm Hg. Nystatin was stopped and changed to fluconazole. The above symptoms did not recur.
  • 病例报告
    . 2004, 6(4): 257-257.
  • 药物安全动态
    . 2006, 8(3): 233-233.
  • 病例报告
    . 2006, 8(4): 301-301.
  • 不良事件
    . 2002, 4(1): 57-57.
  • 个案分析
    . 2003, 5(2): 118-119.
  • 病例报告
    . 2004, 6(2): 119-119.
  • 中药不良反应
    . 2006, 8(6): 462-462.
  • 病例报告
    . 2004, 6(2): 121-121.
  • 不良事件
    . 2002, 4(2): 80-80.
  • 病例报告
    . 2003, 5(3): 186-186.
  • 病例报告
    . 2004, 6(4): 254-255.
    A 40-year-old man was hospitalized with anorexia, weakness and yellow urine for 3 days after 1 month of antituberculosis therapy.Physical examination showed mild yellow sclera and secondary pulmonary tuberculosis. He was diagnosed as tuberculosis and drug-induced hepalitis. The patient was treated with antituberculosis drugs,drugs for liver disorders, and intravenous infusion of tiopronin 0.2g/day. His appetite was improved, while weakness,yellow urine and sclera were partially resolved. Several days later, the patient developed chill and hyperpyrexia(39.5℃). The temperature was gradually returned to normality and chill was resolved 10 minutes after treatment of promethazine and aminopyrine. When the patient was given tiopronin the next day, chill and hyperpyrexia recurred. It was considered that the symptoms were associated with tiopronin, since no adverse reactions occured after tiopronin was discontinued.
  • 病例报告
    . 2006, 8(4): 300-300.
  • 专题讲座
    . 2002, 4(5): 324-329.
  • 病例报告
    . 2001, 3(2): 113-113.
  • 病例报告
    . 2006, 8(2): 137-138.
  • 病例报告
    . 2006, 8(2): 139-139.
  • 病例报告
    . 2006, 8(2): 130-130.
  • 病例报告
    . 2005, 7(6): 455-455.
  • 网络医药
    . 2003, 5(6): 396-398.
  • 病例报告
    . 2005, 7(1): 55-56.
    A 4-year-old boy was hospitalized with fever for 2 days. He had no history of taking aspirin previously. Physical examination revealed a temperature of 40.2℃, pharynx congestion,enlarged tonsils and normal lungs.Lab findings included WBC count of 13.5x109/L with 84% neutrophils and 16% lymphocytes.The patient was diagnosed as acute tonsillitis and treated with DL-lysine aspirin 0.3g by intramuscular injection.10 minutes later,the boy developed nausea,non-projectile vomiting and dull look. It was considered the warning signs of convulsions induced by hyperpyrexia,and treated with phenobarbital 0.1g by intramuscular injection.He had shortness of breath,moist rales with bilateral lungs and 80% serum oxygen saturation.The symptoms were not lessened after giving oxygen supplement and hydrocotisone etc.2 hours later,the boy developed dyspnea,cyanosis and paleness. His conditions were deteriorated progressively after treatment including trachea intubation and mechanical ventilation.He died of respiratory and circulatory failure.
  • 安全信息
    . 2007, 9(2): 150-150.
  • 安全信息
    . 2007, 9(3): 226-226.
  • ADR术语
    . 2002, 4(1): 64-66.
  • 病例报告
    LIU Jian-feng;FENG Qiao-fei
    . 2012, 14(2): 126-2.
    A 57-year- old woman received oral calcium carbonate and calcitriol for severe osteoporosis. One week later, an IV infusion of zoledronic acid 5 mg dissolved in 0.9% sodium chloride solution 100 ml was given. On day 2, she developed fever, generalized skin rash, dizziness, asthenia, as well as joint pain and muscle aches in her lower limbs. She was given dexamethasone and loratadine immediately. On day 7, her clinical symptoms such as dizziness, asthenia, as well as joint pain and muscle aches in her lower limbs disappeared, and her body temperature returned to normal. On day 10, her skin rash completely disappeared.
  • 病例报告
    ZHOU Qing;PAN Jun;WU Zhong;WANG Dong-jin
    . 2012, 14(6): 380-2.
    A 41-year-old man underwent artificial cardiac valve replacement surgery 5 years ago and, after surgery, he received oral warfarin 3 mg once daily. Recently, he suddenly developed left lower limb pain, and presented to a hospital. Examination of coagulation function showed the following results: prothrombin time>120 s, activated partial thromboplastin time>120 s, international normalized ratio 8.5 and D-dimer 0.58 mg/L. He was diagnosed with deep vein thrombosis in left lower limb by ultrasonography. He was given dextran 40 and warfarin was continued. Three days later, the patient developed severe pain in his left abdomen and abdominal distention. Abdominal CT scan revealed retroperitoneal hematoma. Spontaneous retroperitoneal hemorrhage was diagnosed. Conservative therapy such as vitamin K1 and fresh frozen plasma were given, but these had no apparent effect. On day 2, digital subtraction angiography demonstrated bleeding from the left third lumbar artery. The bleeding was stopped after embolization with a gelatin sponge. His abdominal pain improved and hemorrhage ceased.
  • 安全信息
    . 2012, 14(5): 333-1.
  • 病例报告
    Yang Qiang;Nie Xiuhong;Teng Guojie
    . 2011, 13(5): 314-2.

    A 65-year-old man received high-flow oxygen inhalation, an IV infusion of imipenem/cilastatin sodium 0.5 g every 8 hours, an IV infusion of vancomycin 0.5 g every 8 hours, an IV infusion of moxifloxacin 0.4 g once daily, and an IV infusion of methylprednisolone 160 mg/d for pulmonary infection and respiratory failure. After receiving 3-day treatment, the patient was intubated and placed on a mechanical ventilator because of poor control of his condition. In addition, he was given an intravenous vecuronium 4 mg every 4-6 hours (16-20 mg/d) due to agitation. Meanwhile methylprednisolone was reduced to 80 mg/d given by IV infusion. After 5 days of treatments, the patient developed difficulty keeping eye open, muscle power decrease, reduced tendon reflex, and a creatine kinase level of 650 U/L. The patient was considered to be diagnosed as having acute steroid myopathy. Vecuronium was stopped and switched to propofol. Methylprednisolone was reduced to 40 mg/d given by intravenous infusion. Two days later, his symptoms relieved, difficulty keeping eye open subsided, and muscle power gradually improved. Five days later, his creatine kinase level was 119 U/L and the symptoms of muscular weakness disappeared.

  • 病例报告
    Xie Cheng;Gao Jie;Zhao Yuqin;Miao Liyan
    . 2011, 13(6): 377-2.
    A 75-year-old male patient developed infective endocarditis after a permanent pacemaker implantation for atrioventricular block. He received initially an IV infusion of cefoperazone sodium/sulbactam sodium 3.0 g every 12 hours for 4 days alone which was replaced by an IV infusion of vancomycin 1.0 g every 12 hours for 3 days and then finally was treated with an IV infusion of linezolid 600 mg every 12 hours for 44 days alone. Before administration of linezolid, laboratory tests revealed a WBC count of 12.00×109/L, a RBC count of 3.92×1012/L, a platelet (PLT) count of 158×109/L, and a Hb level of 115 g/L. However, on day 19 of treatment, routine blood testing showed the following values: WBC count 2.81×109/L, RBC count 3.39×1012/L, PLT count 74×109/L, and Hb 102 g/L. The following routine blood tests showed that complete blood cells count values were below normal and the lowest values were as follows: WBC count 2.69×109/L, RBC count 2.51×1012/L, PLT count 48×109/L, and Hb 69 g/L. Linezolid was not stopped because of the patient’s condition, and symptomatic treatments with recombinant human granulocyte colony-stimulating factor, ferrous succinate and red cells suspension were given. The patient received linezolid for a total of 44 days and then the drug was withdrawn. On day 18 of drug discontinuation, the results of his routine blood tests were normal: WBC count 5.07×109/L, RBC count 3.02×1012/L, PLT count 156×109/L, Hb 102 g/L.
  • hang Shuyi, Wu Liyong, Yin Na, Liu Jia, Jia Jianping
    . 2016, 18(3): 211.
    A 63-year-old woman with chronic obstructive pulmonary disease for 10 years received compound phenytoin sodium (2 tablets, three times daily) from January 2013 to January 2015. The patient developed a paroxysmal dysbasia and facial involuntary movement in April 2014 (16 months after medication) and 4 times outbreaking from April 2014 to January 2015. She was considered the dystaxia due to compound phenytoin sodium. Compound phenytoin sodium was stopped immediately and an IV infusion of coenzyme complex injection 400 U once daily was given. Twelve days later, the patient could walk alone without obvious involuntary movement in her face. Then she was discharged. The result of follow-up 2 months after discharge showed that the symptoms had no recurrence, and the patient could walk alone. Her daily life returned to normal.
  • Ma Zetong, Gong Rui, Fu Nansi, Gao Hua
    . 2017, 19(2): 127-129.
    A 68-year-old female with infection after left knee replacement received an IV infusion of cefoperazone sodium and sulbactam sodium 2.0 g twice daily. It was about to the ending of the second time of IV infusion, the patient developed anhelation, dyspnea, sweating profusely, and fever. The IV infusion was stopped immediately. Three days after drug withdrawal, the patient presented with millet to soya bean size red rash on her trunk which had clear ambit and faded after pressing. It was considered as erythema morbilliforme and needed to be investigated by a dermatologist. The patient received loratadine granules 10 mg once daily and topical application of calamine lotion. Eight days after drug withdrawal, the patient developed skin ulceration on her waist, back, right scapular, and paravertebrae. There were blisters on the left elbow ulnar side and skin peelings on her her waist and back. She was diagnosed as toxic epidermal necrolysis due to cefoperazone sodium and sulbactam sodium by the Department of Dermatology consultation. The patient received IV infusion of calcium gluconate; calglucon; glucal 20 ml, methylprednisolone 80 mg, and human immuno-globulin 2.5 g once daily; intravenous injection of diphenhydramine hydrochloride 20 mg every 12 hours; and topical application of nanoparticulate silver antibacterial gel. The patient developed pulmonary infection and the symptoms of skin peeling off had no improvement. On day 14 of drug withdrawal, her family members decided to give up treatment because of economic reason. It was told that the patient died on the third day after discharge by telephone follow-up.
  • Liu Xianjun
    . 2015, 17(1): 58-2.
    A 74-year-old man with old fracture of right femoral neck was planned to undergo CT angiography to determine whether there were both lower extremities arteriosclerosis occlusion. The patient was negative for iodine anaphylactic test. About one minute after an IV injection of iobitridol start, the patient suddenly experienced loss of consciousness, asphygmia, and undetectable blood pressure. Iobitridol was stopped immediately and he was given oxygen inhalation and cardiopulmonary resuscitation immediately. Five minutes later, his heart rate was 121 beats per minute and blood pressure was 86/47 mmHg. An intravenous injection of dexamethasone 10 mg and epinephrine 3 mg were administered. Twenty-three minutes later, his heart rate was 119 beats per minute and blood pressure was 205/140 mmHg. Agitation appeared in the patient. Twenty-nine minutes later, his heart rate was 99 beats per minute and the electrocardiogram showed sinus rhythm. The patient was continuously treated with anti-infection, improvement of cardiac function, and alleviation of pulmonary edema. Seven days later, the patient′s condition was stable.
  • Liu Haiyan, Li Tingting, Yang Yabin
    . 2015, 17(2): 142-143.
    A one-year-old boy took 2 tablets of chloramphenicol (0.5 g)  and swallowed when playing alone, the tablets were put on the table by his mother. The boy developed dysphoria, nausea, vomiting,  abdominal distention, slight cyanosis, dyspnea, and tachycardia 4.5 hours after the accidental medication. Laboratory tests showed the following values: carbon dioxide-combining power 14.0 mmol/L, creatine kinase 137 U/L, creatine kinase isoenzyme 45.0 U/L, lactate dehydrogenase 635 U/L, myoglobin weakly positive. ECG showed atrial fibrillation with rapid ventricular rate. The boy was diagnosed as: (1) gray baby syndrome due to chloramphenicol; (2) myocardial injury; (3) possibly complicated with metabolic acidosis. He underwent comprehensive treatments immediately including oxygen inhalation, inotropic agents,and diuresis. The boy developed cyanosis on face and lip, heart failure, pulmonary edema, and unconsciousness. Finally, the boy died despite resuscitation attempts about 10 hours after the accidental swallowing of chloramphenicol.
  • Wei Huabo, Zhang Junguo, Tan Bing, Dong Yang
    Adverse Drug Reactions Journal. 2022, 24(3): 150-152. https://doi.org/10.3760/cma.j.cn114015-20210425-00499
    A 65-Year-old male patient with squamous cell lung cancer received chemotherapy with paclitaxel (210-mg by an IV infusion on day 1) and carboplatin (0.5 g by an IV infusion on day 1; 21 days was a cycle) and targeted therapy with apatinib (0.25 g orally once daily). About 1 hour after the first oral administration of apatinib, the patient developed dyspnea, chest tightness, followed by limb numbness and fatigue. About 1 hour after the second administration, the above symptoms recurred, accompanied by lower limb pain, speak disability, and arrhythmia. The symptoms were considered to be related to apatinib. The drug was stopped and the treatments including noninvasive ventilator assisted breathing, antiallergic, antispasmodic, and antiasthmatic were given. Five days later, the above symptoms disappeared.
  • Zhu Xiuping, Xu Chen, Yu Lingyan, Zhang Jiali, Dai Haibin
    Adverse Drug Reactions Journal. 2023, 25(4): 218-222. https://doi.org/10.3760/cma.j.cn114015-20220810-00732
    Objective To investigate the incidence of alopecia after pediatric liver transplantation and its related risk factors. Methods A retrospective case-control study was used. The subjects were children who underwent liver transplantation in the Second Affiliated Hospital, Zhejiang University School of Medicine from July 2019 to December 2020. The information such as gender, age, primary disease, preoperative body mass index (BMI), graft-to-recipient weight ratio (GRWR), albumin, hemoglobin and total bilirubin before the operation, and blood concentration of tacrolimus were collected from the hospital information system. The follow-up content included whether there was alopecia after surgery, the site of alopecia, the degree of alopecia, the occurrence time and recovery time of alopecia after surgery. The children were divided into alopecia group and non-alopecia group according to whether there were alopecia, and the related indicators were analyzed by univariate analysis, and the results were expressed by odds ratio (OR) and its 95% confidence interval (CI). Results A total of 40 children who met the inclusion criteria were collected, including 20 males and 20 females. The median age at surgery was 20(11, 43) months and the age ranged from 5 months to 13 years. The BMI was (17.1±2.1) kg/m2 and the GRWR was (2.6±0.7)%. The serum TBil, blood albumin, and hemoglobin before the operation were 120 (27, 191) μmol/L, (33±5) g/L, and (100±14) g/L, respectively. The blood concentration of tacrolimus was (10.37±2.15) μg/L within one month after the operation. Among the 40 children, 17 developed alopecia, including 8 males and 9 females. The severity of alopecia was S1 in 16 cases and S2 in 1 case. There were 14 cases of local hair loss and 3 cases of general hair loss. The occurrence time of alopecia in all 17 patients was distributed from 4 days to 9 months after operation, including 15 cases within 1 month after operation, and 2 cases 3 and 9 months after operation, respctively. All patients did not receive symptomatic treatment for alopecia and returned to normal within 1 year after the operation. Univariate analysis showed that low preoperative albumin level and high concentration of tacrolimus within one month after surgery were risk factors for alopecia after pediatric liver transplantation [(31±4)g/L vs. (34±5)g/L, OR=0.83, 95%CI: 0.71-0.98, P=0.026; (12.0±2.1)μg/L vs. (9.2± 1.2)μg/L, OR=2.80, 95%CI: 1.55-5.05, P=0.001]. Conclusion Low preoperative albumin level and high concentration of tacrolimus within one month after surgery may be risk factors for alopecia in children after liver transplantation.
  • 会议纪要
    Wang Yawei;Li Xiaoling;Wang Yuqin
    . 2014, 16(3): 190-2.
  • 综述
    Yu Nan;Gao Ying;Li Xuesong;Guo Xiaohui
    . 2014, 16(2): 111-3.

    Sunitinib, an oral multi-targeted tyrosine kinase inhibitor, is approved for the treatment of metastatic renal cell carcinoma and gastrointestinal stromal tumor after imatinib treatment failure or intolerance. Hypothyroidism induced by sunitinib has a high incidence and symptoms are not typical. The symptoms include fatigue, palpitation, chills, and somnolence, and they are difficult to be distinguished from the tumor-associated symptoms and other common adverse reactions of sunitinib. The possible mechanisms of hypothyroidism induced by sunitinib include destruction of thyroid tissue, inhibition of thyroid peroxidase, and vascular injuries. The patients′ thyroid functions should be monitored regularly during the sunitinib treatment, and thyroid hormone replacement therapy should be given in some severe cases.

  • Kang Ying, Han Qing, Qi Ying, Wang Li
    . 2017, 19(3): 218.
    An 82-year-old female patient took dipyrone 0.5 g by herself because of epigastric pain.  About 30 minutes later, she developed muscular soreness, weakness, reduced urine volume, and red-wine-colored urine. The results of laboratory tests reported the next day showed the following: creatine kinase(CK) 4 672 U/L, creatine kinase isoenzyme MB(CK-MB) 107 U/L, serum creatinine(Scr) 232 μmol/L, alanine aminotransferase(ALT) 297 U/L, aspartate aminotransferase(AST)432 U/L, cardiac troponin I(cTnI)2.1 μg/L, and NT-pro brain natriuretic peptide(NT-proBNP) 10 779 ng/L. Fluid infusion, liver-protective treatments, and other symptomatic treatments were given, and 2 days later, the patient′s myalgia was significantly alleviated, urine volume and the color of urine returned to normal, and the levels of CK, CK-MB, Scr, ALT, AST, cTnⅠ, and NT-proBNP were 578 U/L, 16 U/L, 87 μmol/L, 99 U/L, 59 U/L, 0.157 μg/L, and 1 975 ng/L, respectively.
  • Zhou Xi, Qiu Feng, Long Rui
    . 2017, 19(4): 299.
    A 61-year-old male patient with type 2 diabetes received an oral metformin 850 mg about 30 minutes after drinking about 400 ml liquor containing 52% of alcohol into an empty stomach. About 4 hours later, the patient developed stuffy pain below xiphoid process and palpitation, and about 7 hous later, he developed nausea and vomiting. The laboratory examination showed that the blood pH 7.16, lactic acid 15.0 mmol/L, base excess -12.6 mmol/L, bicarbonate 15 mmol/L. He was diagnosed as diabetic lactic acidosis. Comprehensive treatments such as oxygen inhalation, acidosis correction, fluid infusion were given and metformin was changed to oral rosiglitazone 4 mg once daily. Eighteen hours later, the discomfort below xiphoid process was markedly improved, nausea and vomiting did not recur, his laboratory examination results showed the blood pH 7.41, lactic acid 1.8 mmol/L, base excess 2.3 mmol/L, and bicarbonate 27 mmol/L.
  • 病例报告
    Ren Xiaolei;Huang jing;Li Yuzhen
    . 2010, 12(4): 239-2.
    A 18-year-old man underwent hematopoietic stem cell transplantation for acute T lymphoblastic leukemia. On day 22 transplantation,the patient received an IV infusion of cyclosporine 25 mg twice daily and, 5 days later, the dose was increased to 35 mg twice daily, and meanwhile an infusion of foscarnet sodium 3 g twice daily was given. On day 20 of therapy, the patient developed nausea, vomiting, gaze in both eyes, and no response to voice stimuli accompanied by convulsions in limbs and loss of consciousness. His serum creatinin level increased to 129 μmol/L. Phenobarbital used for sedation, mannitol used for dehydration, and other symptomatic treatments were given. After foscarnet sodium was discontinued and cyclosporine dose was decreased to 25 mg every 12 hours, his epileptic seizures did not recur and the serum creatinine level returned to within normal range.
  • LEI Zhao-bao
    Erlotinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) and has been used clinically in the treatment of non-small cell lung cancer. Interstitial lung disease (ILD) is a serious and rarely adverse reaction induced by erlotinib. The incidence of ILD was 0.1%-4.8% and the mortality rate was 0.8%-2.4%. The median time of erlotinib induced ILD was 22 d after using the drug. The clinical manifestations of ILD were dry cough, low-grade fever, dyspnea and so on. Imaging examination showed diffuse ground-glass shadows in lungs. The laboratory examination showed hypoxemia. The risk factors of ILD induced by erlotinib are male, advanced age, basic lung diseases and smoking. The main mechanisms of erlotinib-induced ILD are immune-mediated reactions and direct drug toxicity. The effective measures to prevent erlotinib-induced ILD should be avoid using in high-risk patient, use low-dose, avoid synchronous use with other chemotherapy and/or radiotherapy, and strengthen the monitoring of respiratory function. Once ILD developed, erlotinib should be discontinued immediately and replaced by other EGFR-TKI. The main aims of treatments of erlotinib-induced ILD are to suppress the inflammatory responses and prevent pulmonary fibrosis. The main measures include oxygen inhalation, using glucocorticoid, prevention of infection, and symptomatic treatment.
  • CHEN Rui;YUE Ming;LIU Xiao-yong
    A 26-year-old female patient received an IV infusion of ceftriaxone 2 g once daily for upper respiratory tract infection. On day 4, the patient developed persistent distending pain in her lower abdomen. Abdominal ultrasonography and CT examinations revealed bilateral ureteral calculi. The patient received symptomatic treatments and supportive therapy. On day 5, little sediment was excreted in the urine. On the same day, the abdominal pain was alleviated and symptoms of urinary frequency and urgency disappeared. On day 6, CT reexamination showed that the bilateral ureteral calculi disappeared.
  • LIU Yang;JIANG Yu-yong;DONG Xiao-dong;MENG Pei-pei
    Two patients, a 32-year-old man and a 27-year-old woman, had normal liver function during antituberculous treatment. Oral allopurinol 0.1 g thrice daily was added to their regimen due to hyperuricemia. They developed fever and rash after 2 weeks. Laboratory tests showed the following values: alanine transaminase (ALT) 1182 U/L, aspartate transaminase (AST) 595 U/L, total bilirubin 25.9 mmol/L in patient 1; ALT 1452 U/L, AST 1942 U/L in patient 2. Allopurinol and the antituberculous drugs were discontinued. Both patients received liver-protective treatment. The results of their liver function tests basically returned to normal on days 14 and 25 of treatment, respectively. In patient 1 antituberculous treatment was continued, he had the normal liver function during 4 months of follow-up. In patient 2 antituberculous treatment was stopped because of the stable condition.
  • LIU Yan-qiu;PU Yan-fang
    . 2013, 15(3): 172-2.

    A 70-year-old woman received oral carbamazepine for epilepsy. Two weeks later, the treatment was switched to gabapentin 300 mg once daily on the first day followed by 300 mg twice daily due to poor efficacy. One month later, she presented with upper abdominal pain after eating barbecue food. Laboratory tests revealed the following levels: alanine aminotransferase (ALT) 403 U/L, aspartate aminotransferase (AST) 740 U/L, lactate dehydrogenase (LDH) 601 U/L, alkaline phosphatase (ALP) 161 U/L, and γ-glutamyl transferase (γ-GT) 295 U/L. Gabapentin was stopped and liver protective treatment was given. One week later, repeat liver function tests showed the following levels: ALT 38 U/L, AST 19 U/L, LDH 143 U/L, ALP 146 U/L, and γ-GT 134 U/L.

  • SUN Bing;SONG San-tai;JIANG Ze-fei;HUANG Zhou;WANG Tao;ZHANG Shao-hua;WU Shi-kai
    . 2013, 15(3): 167-2.

    A 55-year-old female patient received an IV infusion of docetaxel 140 mg for lymph nodes, bones, and liver metastases after operation of breast cancer. In the morning of day 6 after chemotherapy, she developed a lot of fresh blood in her stool. Her heart rate was 120 beats/min. Her routine blood tests showed the following levels: white blood cell count 0.9×109/L, hemoglobin 103 g/L, platelet count 62×109/L. She received an IV injection of hemocoagulase 2 U and an IV infusion of aminomethylbenzoic acid 0.2 g immediately. In the noon of the same day, a lot of fresh blood appeared in the patient′s stool again and she felt palpitation and fatigue. Routine blood tests showed a white blood cell count of 0.5×109/L, a hemoglobin level of 75 g/L, and a platelet count of 52×109/L. She received enema with Yunnanbaiyao(云南白药)1 g+lyophilized thrombin powder 4000 U+iced saline 100 ml every 2 h; continuous IV infusion of somatostatin 3 mg for 12 h; transfusion of suspended red blood cells 2 U and apheresis platelets 1 U. The electron colonoscopy scanning showed multiple rectal ulcers with one site of bleeding. Then endoscopic hemostasis was performed, and no bleeding recurred.

  • ADR监测与防治
    Mohamed H.Farah;I.Ralph Edwards;Marie Lindquist
    . 2000, 2(2): 105-108.
  • 病例报告
    . 2000, 2(1): 57-57.
  • 病例报告
    Luo Wenfeng
    . 2009, 11(5): 370-2.
    A 38-year-old man with ankylosing spondylitis received methotrexate (dosage not stated) and thalidomide (150 mg/d) due to poor contorl of conditions. Four months later, his smptoms improved. The dosage of thalidomide was decreased to 100 mg/d for maintenance therapy and his condition was stable. Five months later, the patient developed involuntary intermittent urination, complicated by frequent micturition, urgency and an increase in the frequency of nocturia. Thalidomide was stopped and methotrexate was continued alone for maintenance therapy. His sympoms gradually improved. Involuntary intermittent urination recurred after readministration of thalidomide and subsided after the drug discontinuation.
  • 不良事件
    . 2005, 7(1): 54-54.
  • 不良事件
    . 2003, 5(5): 345-345.
  • 病例报告
    . 2001, 3(4): 254-255.
  • 病例报告
    . 2001, 3(4): 252-252.
  • 病例报告
    . 2005, 7(4): 299-299.
  • 病例报道
    . 1999, 1(1): 50-50.
  • ADE简报
    . 2000, 2(2): 141-141.
  • 不良事件
    . 2003, 5(6): 415-415.
  • 药物滥用
    . 2006, 8(1): 40-41.
  • 不良事件
    . 2003, 5(3): 200-200.
  • 病例报告
    . 2006, 8(4): 299-299.
  • WHO信息
    . 2004, 6(3): 203-203.
  • 病例报告
    . 2003, 5(3): 194-194.
  • 病例报告
    . 2003, 5(2): 132-132.
  • 不良事件
    . 2003, 5(2): 124-124.
  • ADR术语
    . 2004, 6(1): 65-65.
  • ADE简报
    . 2001, 3(1): 51-51.
  • Shan Wenwei
    Adverse Drug Reactions Journal. 2009, 11(3): 210-2.

    A 40-year-old man with hypertension received captopril 6.25 mg three times daily. One week later, the dosage of captopril was increased to 12.5 mg three times daily. After one month, his TBil increased from 13.6 μmol/L to 37.3 μmol/L. Captopril was discontinued. His TBil was 28.7 μmol/L one week later and 15.6 μmol/L one month later. Routine urine and blood investigations were normal, and viral serology was negative for hepatitis virus markers. Increased bilirubin was considered to be captopril-associated. Subsequently, captopril was changed to nifedipine sustained-release tablets and above-mentioned symptoms did not recur.

  • 病例报告
    . 2006, 8(4): 296-297.
  • 病例报告
    . 2006, 8(4): 261-261.
  • 病例报告
    . 2005, 7(6): 471-471.
  • 不良事件
    . 2006, 8(2): 104-104.
  • 药物安全动态
    . 2006, 8(1): 72-73.
  • 不良事件
    . 2006, 8(2): 143-143.
  • 病例报告
    . 2001, 3(2): 118-119.
  • WHO信息
    . 2001, 3(2): 130-130.
  • 病例报告
    . 2003, 5(6): 400-400.
  • 病例报告
    . 2005, 7(4): 312-312.
  • 病例报告
    . 2002, 4(6): 405-406.
  • 病例报告
    LI Yan;LIANG Ning-sheng
    . 2012, 14(5): 316-2.
    A 71-year-old male patient developed allergic skin reactions following receiving fluconazole for fungal infections of the intestinal fistula and the abdominal cavity after undergoing subtotal gastrectomy for gastric ulcer and pyloric obstructions. So the treatment was switched to an IV infusion of micafungin 50 mg dissolved in 100 ml of 0.9% sodium chloride solution once a day. After receiving the infusion about 65 ml,the patient suddenly presented with gerenalised cyanosis, short of breath, and brownish red urine. Laboratory tests showed the following values: WBC count 52.5×109/L, RBC count 2.7×1012/L, Hb 78 g/L,PLT count 118×109/L, blood urea nitrogen 21.5 mmol/L, creatinine 113 μmol/L, urine occult blood 200 cell/μl, and many red blood cells per field . The infusion was discontinued immediately and he received blood dialysis and other treatments. His conditions gradually improved and, two weeks later, his routine blood and urine tests and renal function basically normalized.
  • 病例报告
    Lu Mina;Wang Weib;Zhou Yinga;Liang Yana;Cui Yimina;Guo Xiaohuib
    . 2011, 13(3): 180-2.
    A 60-year-old man with type 2 diabetes mellitus received an IV infusion of pamidronate disodium 60 mg dissolved in 0.9% sodium chloride 500 ml, which was given within 4-5 hours via an infusion pump, for bone metastasis of small cell lung cancer. The dosing interval was once every 1-3 months. He received pamidronate 10 times within 17 months. Subsequently, the patient received head radiotherapy for brain metastasis. Two days before radiotherapy, he was given prednisone 10 mg thrice daily for 37 days. After radiotherapy completion, the patient was retreated with pamidronate disodium therapy, and the dosage and administration were the same as the previous regimen. He received pamidronate 5 times within one year. During this year, the patient experienced recurrent gingival swelling, pains and pyorrhea. Osteonecrosis of the jaw (ONJ) was diagnosed by dentists. ONJ was considered to be associated with pamidronate disodium, or both bisphosphonates and radiotherapy.
  • 病例报告
    Liang Ji;Su Tao
    . 2011, 13(3): 190-2.
    A 62-year-old man with actinic dermatitis received a 4-day treatment with an IV infusion of compound glycyrrhizin 20 ml/d (containing 40 mg of glycyrrhizin) , oral ebastine, and oral cetirizine, followed by a 10-day treatment with traditional Mongolian medicine (specific composition not stated). Because his skin symptoms did not significantly improved, he was administered 2 compound glycyrrhizin tablets (containing 50 mg of glycyrrhizin) twice daily. One week later, the patient developed edema in his eyelids and lower extremities. His blood pressure was 180/100 mm Hg. The drug was discontinued immediately. Laboratory tests revealed the following levels and values: serum potassium 3.1 mmol/L, serum sodium 151 mmol/L, SCr 82 μmol/L, renin 0.40 pg/L, angiotensin II 98 ng/L, and aldosterone 164 ng/L. He was treated with oral triamterene 50 mg twice daily and oral nifedipine 20 mg twice daily. After one day, his edema disappeared and blood pressure was maintained at 140-160/90-100 mm Hg. A repeat laboratory testing showed a serum potassium level of 4.7 mmol/L and a serum sodium level of 141 mmol/L.However, his SCr level increased to 129 μmol/L and the highest level was 144 μmol/L. Two days after triamterene withdrawal, the laboratory results showed the following levels: SCr 86 μmol/L, serum potassium 3.7 mmol/L, serum sodium 141 mmol/L, and normal levels of renin, angiotensin II, and aldosterone. Pseudohyperaldosteronism was diagnosed and considered to be related to glycyrrhizinic acid.
  • 病例报告
    Li TongyunLiu Haiyan
    . 2011, 13(2): 112-2.
    A 22yearold female patient was given progesterone 40 mg thrice daily, methyltestosterone 5 mg once daily, nifuratel 0.4 g thrice daily, and 2 Luohuazizhu tablets thrice daily for irregular menstruation and vaginitis. Three days later, the patient developed jaundiced skin and sclera, and teacolored urine. Laboratory tests showed the following values: red blood cells 3.02×1012/L with reticulocytes 0.034, total bilirubin 141.3 μmol/L, direct bilirubin 9.7 μmol/L, and indirect bilirubin 131.6 μmol/L. Progesterone, methyltestosterone, and nifuratel were stopped, Luohuazizhu tablets was continued, and treatment with a variety of drugs was given. Her jaundice gradually subsided. The color of urine gradually returned to normal . Eleven days after the withdrawal of the medicines, jaundice disappeared completely. Laboratory tests revealed the following levels: red blood cells 2.94×1012/L with reticulocytes 0.021, total bilirubin 15.2 μmol/L, direct bilirubin 5.8 μmol/L, and indirect bilirubin 9.4 μmol/L.
  • Huang Wenhui, Zhang Yakun, Hou Xingyun, Lin Xiaofeng
    . 2016, 18(4): 261.
    ObjectiveTo evaluate the risk of  arthralgia due to dipeptidyl peptidase-4 (DPP-4) inhibitors.MethodsThe documents involving arthralgia due to DPP-4 inhibitors ending in February 2016 were searched from correlative data base and online library. DPP-4 inhibitors was used in the test group while placebo was used in the control group. The relevant data were collected from enrolled documents and the  quality of RCTs was assessed. The software Review Manager 5.3 was used for Meta-analysis and the results were expressed  in RR and 95%CI.ResultsA total of 22 RCTs were enrolled into the Meta-analysis and 9 927 patients [6 760 cases in the test group (T) and 3 167 cases in the control group(T)]  were treated 12 to 206 weeks. The number of patients who were enrolled into the study on sitagliptin,  saxagliptin, vildagliptin,  linagliptin, and  alogliptin were 954 (T: 545, C: 409), 4 246 (T: 2 923, C:1 323) , 899 (T: 528, C: 371), 2 624 (T: 1 893, C: 731), and 1 204 (T: 871, C: 333), respectively.  The results of quality evaluation to all literatures showed  13 for Grade A and 8 for Grade B. The results of Meta analysis showed that the risk of arthralgia induced by saxagliptin and vildagliptin was higher than that by placebo (RR=1.35, 95%CI: 1.01-1.81, P=0.04 and RR=2.80, 95%CI: 1.29-6.08, P<0.01).The results of subgroup analysis showed that the risk of arthralgia induced by saxagliptin 2.5 mg/d added to metformin or TZDs, saxagliptin 10 mg/d monotherapy or added to metformin,  and vildagliptin 50 mg/d was higher than that by placebo (RR=1.74, 95%CI: 1.06-2.88, P=0.03; RR=1.97, 95%CI: 1.01-3.82, P=0.05;  RR=1.86, 95%CI: 1.06-3.28, P=0.03; RR=2.55, 95%CI: 1.15-5.64, P=0.02). The risk of arthralgiadue induced by itagliptin, linagliptin, and alogliptin were similar with that by placebo(all P>0.05). ConclusionsSaxagliptin and vildagliptin  may increase the risk of arthralgia. The patients with type 2 diabetes and joint disease should choose sitagliptin, linagliptin or alogliptin when they were using DPP-4 inhibitors.
  • Lin Zhiqiang
    Adverse Drug Reactions Journal. 2024, 26(9): 519-523. https://doi.org/10.3760/cma.j.cn114015⁃20240902⁃00029
    Unsafe medication and medication errors are the main causes of avoidable harm in the health system. In order to reduce drug?related harm, it is necessary to pay special attention to medication safety in high?risk situations, medication safety during polypharmacy, and medication safety during the transitions of medical care. The main factors leading to high?risk situations include drugs (high?alert drugs), human (drug provider and patient), and environment (drug management, treatment environment and human resources, etc.). Strengthening management for polypharmacy can promote the rational use of drugs and minimize drug?related harm. Reducing medication errors and/or adverse drug events in transitions of care requires collaboration from multiple parties, including interdisciplinary care teams such as physicians, pharmacists, and nurses, as well as active participation from patients and their families. Compared with developed countries, there is still a significant gap in the 3 areas in China, and physicians, pharmacists, and nurses need to take active actions and make joint efforts to ensure the medication safety of patients.
  • Liu Qinglan, Zhang Jianing, Song Jingsai, Nie Zhifeng, Ren Yanli, Yang Wenhui
    Adverse Drug Reactions Journal. 2024, 26(12): 737-742. https://doi.org/10.3760/cma.j.cn114015-20240705-00523
    Objective To mine the adverse events (AE) risk signal of azithromycin in children, establish the corresponding pharmaceutical care process, and provide reference for the safe use of azithromycin in clinic. Methods AE caused by azithromycin in children (<18 years) were searched from the US FDA Adverse Event Reporting System (FAERS) database from the 1st quarter of 2004 to the 4th quarter of 2023. The AE was standardized and classified using the preferred term (PT) and system organ class (SOC) in the Medical Dictionary for Regulatory Activities 26.1 version. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used for detection of AE signal of azithromycin. AE that simultaneously met the following conditions was considered as a risk signal: the number of reports≥3, lower limit of the 95% confidence interval of ROR≥1, PRR>2, and χ2>4. Descriptive analysis on the signals was performed. The pharmaceutical care process of azithromycin for children was established based on the results of signal mining and satisfaction survey was conducted. Results A total of 1 457 AE reports related to azithromycin in children were collected, involving 127 PTs and 18 SOCs. The top 5 PTs in the number of reports were rash, pruritus, urticaria, drug hypersensitivity and diarrhea. The top 5 PTs in signal intensity were infantile diarrhea, myasthenia gravis crisis, intermittent explosive disorder, diarrhea neonatal, and infantile vomiting. A total of 16 risk signals that were not recorded in the label were mined out, and the top 5 PTs according to signal intensity were intermittent explosive disorder, conversion disorder, bronchiectasis, tooth discoloration, and choreoathetosis. The analysis of 79 AE reports with death outcomes showed that drug-induced liver injury, Stevens-Johnson syndrome, rash, vomiting, nausea, cyanosis, and diarrhea were related risk signals. Based on the signal mining results mentioned above, the medication safety officer team in our hospital established a pharmaceutical care process of azithromycin application for children, including pre-medication assessment (indications, medical history, heart and liver function, etc.), speed and mode of administration monitoring during the medication, and intervention measures after the occurrence of adverse reactions, and 178 hospitalized children who received azithromycin treatment were monitored. The satisfaction survey results showed the degree of satisfaction was 100%. Conclusions The main AEs related to azithromycin in children are rash, pruritus, urticaria, drug hypersensitivity, and diarrhea, all of which are recorded in the label. In addition, we should also be vigilant against the risk signals such as intermittent explosive disorder, conversion disorder, bronchiectasis, tooth discoloration, and choreoathetosis, which are not recorded in the label. The pharmaceutical care process for azithromycin use in children based on the risk signal mining results is feasible and effective.
  • Fan Tingting, Zhang Juanli, Ding Likun, Zhang Di, Ren Danjun, Liu Meiyou, Wang Jingwen, Wen Aidong
    Adverse Drug Reactions Journal. 2024, 26(2): 65-69. https://doi.org/10.3760/cma.j.cn114015-20230807-00587
    Acetaminophen is currently the most widely used antipyretic analgesics in clinical practice. The conventional dose of acetaminophen is safe and reliable, and long-term use in large quantities can cause damage to important organs. In recent years, some new safety issues of acetaminophen have been found, such as its possibility to increase blood pressure in patients with hypertension, its association with increased risk of cardiovascular disease and all-cause mortality with sodium-containing acetaminophen, the discovery of multiple biomarkers for predicting and diagnosing acetaminophen-related liver injury and its prognosis, and its possibility to increase the risk of kidney injury. The safety prevention strategies for important organ injuries related to acetaminophen include strict restrictions on medication dosage and duration, and attention to medication safety for special populations. For patients who have experienced significant organ damages, their causal relationship should be evaluated, acetaminophen should be stopped, and specific treatment, and symptomatic and supportive treatments should be provided.
  • Hao Yugui, Yi Fanfan, Cheng Wenwei
    . 2015, 17(4): 312.
    A 73-year-old woman with chronic bronchitis, pulmonary interstitial fibrosis, bronchiectasis concurrent infection received an IV infusion of levofloxacin 0.4 g once daily. One week later, her symptoms were not improved. An IV infusion of tigecycline 50 mg twice daily was added to her regimen according to sputum culture results and drug sensitivity test. Nine days later, the patient developed nausea and vomiting. Laboratory tests showed serum urea value of 36.5 mmol/L and amylase 1 166 U/L. Tigecycline was replaced by IV infusion of imipenem and cilastatin sodium 1.0 g thrice daily, and levofloxacin continued. Octreotide acetate and pantoprazole sodium were given. Fasting and fluid supplement were applied. One week later, the nausea and vomiting disappeared. Her serum urea and amylase were 8.1 mmol/L and 42 U/L, respectively.
  • Zhang Jieting, Yang Hai, Zhuang Xuemei, Yu Di
    Adverse Drug Reactions Journal. 2020, 22(11): 638-639. https://doi.org/10.3760/cma.j.cn114015-20200226-00172
    A 67-year-old female patient took aspirin enteric-coated tablets 100-mg thrice daily orally in order to prevent arteriosclerotic cardiovascular disease without doctor′s advice. After 42 days of medication, the patient developed hematochezia, which was progressively aggravated and finally led to severe hemorrhagic anemia (red blood cell count 1.55×1012/L, hemoglobin 47-g/L) and decreased blood pressure (58/33-mmHg). On the 4th day of bleeding, exploratory laparotomy was performed and colonic hemorrhage was diagnosed. Ligation of the mesenteric artery was performed and the patient′s bleeding stopped. The patient took aspirin by herself at a daily dose exceeding the recommended dose without assessment of benefits and bleeding risks by professional physicians and developed severe lower gastrointestinal hemorrhage, which led to hospitalization and surgical treatment. It was a grade H medication error.
  • 论著
    FAN Hua-ying;LIANG Jun-cheng;ZHOU Fen;SUN Li;LI Xiao-xiao;XU Guo-zhu;DENG Yan-ping
    . 2012, 14(3): 142-7.
    ObjectiveTo observe the tolerance of tetrodotoxin injection in opioid-dependent patients in the convalescent stage. Methods An open, non-controlled trial was conducted. The opioid-dependent patients aged 18 to 45 years, male or female, during the convalescent stage were enrolled as subjects. Two different dosage regimens were used in the trial: a single-dose regimen (5 μg or 10 μg or 15 μg once daily intramuscularly) and multi-dose regimen (10 μg or 15 μg thrice daily intramuscularly for 7 days). During the trial phase, the changes in vital signs and adverse reactions were observed and recorded. Laboratory test and electrocardiogram (ECG) were performed before and after administration and all the results were statistically analyzed. ResultsA total of 30 subjects were enrolled in the study. Eighteen subjects receiving the single-dose regimen were randomly divided into the 5 μg, 10 μg and 15 μg groups and 12 subjects receiving the multi-dose regimen were divided into the 10 μg and 15 μg groups. Each group comprised 6 subjects. During the trial phase, there were no marked changes in vital signs in all subjects. The levels of creatine kinase in the 5 μg and 10 μg groups receiving single-dose regimen and the 15 μg group receiving multi-dose regimen after injection of tetrodotoxin were significantly higher than those before drug administration ( all P<0.05). The levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in one subject in the 5 μg group receiving single-dose regimen after injection of tetrodotoxin were higher than those before drug administration, and did not return to baseline 3 days after the trial completion. After tetrodotoxin injection administration, the levels of creatine kinase of 4 subjects in the 15 μg group receiving multi-dose regimen increased obviously and three of them decreased to normal level 3 days after the trial completion. An ECG revealed ST or T wave changes in 4 subjects receiving the single-dose regimen 24 hours after injection of tetrodotoxin and one subject receiving the multi-dose regimen 7 days after drug administration, and then ST or T wave changes normalised 3 days after the trial completion. Adverse reactions associated with tetrodotoxin injection occurred in 7 subjects, including xerostomia (6 subjects), fatigue (2 subjects), tongue numb (1 subject), limb pain (1 subject), the incidence of adverse reactions was 23.3%. The symptoms of adverse reactions spontaneously subsided or disappeared without withdrawal or dosage reduction. ConclusionTetrodotoxin injection could be well tolerated in a dose of 5-15 μg 3 times a day by intramuscular injection in opioid-dependent patients in the convalescent stage.
  • 病例报告
    SHI Cheng-mei;JIA Dong-lin;LI Zi-jian
    . 2012, 14(3): 184-3.

    A 74-year-old female patient received a preventive use of SC nadroparin calcium 6150 U once a day after undergoing right knee joint replacement surgery. Three days after operation, ecchymoses occurred at the location on her right waist and hip joint. The routine blood test showed a platelet count of 49×109/L and a hemoglobin level of 81 g/L. He then received a transfusion of concentrated red blood cells 400 ml. However, the ecchymoses diffused to the opposite waist and back. On day 5 after operation, nadroparin calcium was considered to be related to thrombocytopenia. Subsequently, nadroparin calcium was discontinued. On day 8 after operation, the color of ecchymoses faded and the platelet count was 88×109/L. On day 10, the patient was discharged with a platelet count of 123×109/L.

  • 安全信息
    . 2007, 9(4): 303-303.
  • ADE简报
    . 2000, 2(1): 60-60.
  • ADR监测与防治
    . 2000, 2(1): 37-38.
  • 不良事件
    . 2003, 5(6): 370-370.
  • 病例报道
    . 1999, 1(1): 54-55.
  • 病例报告
    . 2003, 5(6): 408-409.
  • 不良事件
    . 2004, 6(3): 212-212.
  • 病例报告
    . 2005, 7(2): 131-132.
  • 病例报告
    . 2002, 4(5): 339-339.
  • 病例报告
    . 2005, 7(5): 373-373.
  • 病例报告
    . 2002, 4(3): 185-185.
  • 病例报告
    . 2002, 4(3): 194-194.
  • 病例报告
    . 2000, 2(3): 209-209.
  • 病例报告
    . 2006, 8(4): 303-304.
  • 不良事件
    . 2002, 4(3): 202-202.
  • WHO信息
    . 2002, 4(5): 351-351.
  • ADE简报
    . 2000, 2(4): 264-264.
  • WHO信息
    . 2002, 4(1): 61-61.
  • 病例报告
    . 2004, 6(4): 258-259.
  • 监测简报
    . 2003, 5(2): 129-129.
  • 病例报告
    . 2004, 6(2): 120-120.
  • 病例报告
    . 2006, 8(5): 372-373.
  • ADR监测
    . 2004, 6(4): 268-269.
  • 病例报告
    . 2004, 6(4): 256-257.
  • 综合报道
    . 2000, 2(2): 110-112.
    葡萄柚汁为肝药酶抑制剂,与特非那定同服时将引起后者血浓度升高,增加特非那定的毒副作用,甚至造成死亡。葡萄柚汁尚能使一些经肝脏代谢的药物的体内血浓度升高如:非洛地平,尼索地平、辛伐他汀、环孢素、丁螺环酮、卡马西平、咪达唑仑、三唑仑、西沙必利、丙咪嗪、华法令、茶碱、咖啡因、洛伐他汀等药物。
  • 病例报告
    . 2002, 4(5): 356-356.
  • 病例报告
    . 2004, 6(5): 339-339.
  • ADE简报
    . 2000, 2(3): 200-200.
  • 不良事件
    . 2004, 6(2): 129-129.
  • 病例报道
    . 1999, 1(2): 120-120.
  • 病例报道
    . 1999, 1(2): 115-115.
  • 病例报告
    . 2004, 6(3): 182-182.
  • 不良事件
    . 2005, 7(3): 232-232.
  • ADR护理
    . 2002, 4(4): 244-244.
  • 不良事件
    . 2002, 4(4): 269-269.
  • 病例报告
    . 1999, 1(3): 187-188.
  • 安全信息
    . 2010, 12(2): 149-1.
  • 病例报告
    Zhang Jiali;Yu Xiaojia
    . 2011, 13(2): 123-2.
    A 62yearold man with type 2 diabetes mellitus was administered an IV infusion of regular insulin 10 U and 15% potassium chloride 5 ml dissolved in glucose saline 500 ml to control blood glucose. After 20 minutes of infusion, the patient developed chest distress, short breath, polyhidrosis, and diffuse wheezes in bilateral lungs. The infusion was discontinued immediately and he received oxygen inhalation and aerosol inhalation of salbutamol sulfate.Blood gas analysis revealed a PO2 level of 73 mm Hg and a PCO2 level of 41 mm Hg. About 80 minutes after infusion completion, his asthmatic symptoms improved markedly and he could sleep in the supine position. The next morning, his asthmatic symptoms subsided. His treatment was switched to subcutaneous administration of recombinant human regular insulin and protamine zinc recombinant human insulin to control blood glucose. Subsequently, the abovementioned symptoms did not recur.
  • Adverse Drug Reactions Journal. 2021, 23(2): 112-112. https://doi.org/10.3760/cma.j.cn114015-20210222-00206
  • Cui Xiaohui, Yan Suying, Jiang Dechun, Guo Jingxian, Zhang He, Liang Zhigang, Fei Xiaolu, Yan Bing, Kong Fancui, Li Lingfeng
    ObjectiveTo establish a pre-audit system for medical orders in hospitalized patients and increase the auditing rate in inpatients.MethodsIn the pre-audit system for medical orders, browser/server(B/S) and client/server(C/S) hybrid architecture was adopted and JAVA language was used for programming. The pre-audit system for medical orders was linked to the hospital information system and data integration platform, and audit module was improved on the basis of the pre-audit system for prescriptions which had been successfully operated in Xuanwu Hospital of Capital Medical University. More than 20 thousand related rules were added in the audit think tank for rational drug use of prescriptions and serious errors interception for indications, dosage and administration route, appropriate translation of Chinese patent medicine indications, refinement of compatibility taboos, audit of drug allergy risk, appropriate audit for pain medications, and audit for rational drug use related to height, body weight, body surface area, and test values were performed. The audit think tank for rational drug use was formed, which set up the foundation for intelligent examination of medical orders. The medical orders which were not passed by intelligent examination were transmitted to the pre-audit pharmacist to audit for the second time. By comparing the audit rate of medical orders in hospitalized patients before and after adopting the pre-audit system and the qualification rate at the first 4 months after adopting the system, the application effect was preliminarily evaluated.ResultsAfter launching pre-audit system for medical orders in June 2017, the examination rate of medical orders in inpatients increased from 42.53% (61 139/143 756) to 100% (at the first 4 months, the number of doctor′s orders was 69 183, 74 072, 99 816, and 184 184, respectively). At the first 4 months after the system was launched, the pass rate of audit for medication orders was 69.02% (47 753/69 183), 84.27% (62 416/74 072), 92.69% (92 516/99 816), and 97.21% (179 040/184 184), respectively. The difference in passing rate of audit for medication orders between the 4th month and the first month was statistically significant(χ2=42 548.86, P<0.001).ConclusionsThe pre-audit system for inpatients′ medication orders was successfully established. The intelligent audit for all inpatients realized using this pre-audit system and was of benefit to the rational drug use improvement in hospitals.
  • Gao Tingting, Qin Li, Zhou Xiaoyong
    Two female patients (patient 1, 63 years old; patient 2, 51 years old) with hypertension and chronic renal insufficiency received calcium dobesilate capsules 0.5 g thrice daily. Patient 1 developed red rash on her left upper limb, accompanied by high fever 15 days after medication. Patient 2 developed red rash on her trunk and both thighs, accompanied by cough and high fever 20 days after medication. They developed rash all over the body 1 day (patient 1) and 3 days (patient 2), respectively after the rash occurrence, ulceration on oral mucosa, binoculus, and pudendum 3 days (patient 1) and 9 days (patient 2), respectively after the rash occurrence. They were diagnosed as toxic epidermal necrolysis due to calcium dobesilate capsules. Calcium dobesilate capsules were stopped, and glucocorticoid, human immune globulin, supplement of potassium and calcium, etc. were given. The mucosal erosions were healed or improved on day 13 (patient 1) and 18 (patient 2) of treatments, respectively. The rash faded after 16 days (patient 1) and 25 days (patient 2) of treatments, respectively.
  • Ran Mingyue, Mao Min, Li Chunyan, Huang Li
    . 2015, 17(5): 385.
    An 80-year-old male patient with hypertension, arteriosclerosis, rheumatic heart disease, and atrial fibrillation long-term daily oral warfarin sodium 3 mg once daily. International normalized ratio (INR) was maintained at 2.00 to 3.00. An intravenous infusion of piperacillin sodium and tazobactam sodium 4.5 g every 8 hours, intramuscular injection of compound aminophenazone and barbital 2 ml, oral loxoprofen sodium 30 mg and other drugs were added to his regimen for pulmonary infection and high fever. Before the drug combination, prothrombin time (PT) was 27 s, and the INR was 2.45. Two days later, the patient developed hemoptysis. The next day, warfarin sodium was stopped. On the second day of discontinuation of warfarin sodium,the patient suddenly felt a severe pain in the left upper abdomen with the sign of palpable mass and tenderness. Meanwhile, the PT was 42 s, and the INR was 4.46. On the next day, abdominal ultrasound examination showed that there was a cystic structure in the left abdominal rectus muscle with the size of 4.5 cm×2.7 cm×1.5 cm, and the internal circular high density shadow in the left rectus muscle was found on abdominal ultrasonography. Left abdominal rectus muscle hematoma was considered. Intramuscular injection of vitamin K1 10 mg once daily was given immediately, and ceftazidime was used instead of piperacillin sodium and tazobactam sodium. Two days later, the patient′s symptoms of abdominal pain disappeared, PT fell to 16 s, INR fell to 1.11. One week later, oral warfarin sodium (initial dose 2.25 mg once daily)was given, and adjusted the dose according to INR. One month later, the abdominal ultrasound examination showed that the size of hematoma significantly decreased (3.5 cm × 0.8 cm).
  • INRUD之窗
    . 2014, 16(1): 58-1.
  • 病例报告
    Sun Danping;Liu Guoping;Zhao Min
    . 2014, 16(1): 50-2.

    A 46-year-old male patient with chronic hepatitis B received regularly adefovir dipivoxil 10 mg once daily for more than ten years. Progressive chest pain occured in the recent 3 years and limb weakness and difficult walking occured in recent one year. Physical examination showed that cervical vertebra and upper thoracic vertebra, scapula and rib had tenderness, rib bows were everted, and straight-leg-raising test was positive. Laboratory examination showed the following results: serum potassium 3.1 mmol/L, chloride 111 mmol/L, calcium 2.2 mmol/L, phosphorus 0.53 mmol/L, uric acid 117 μmol/L, fasting plasma glucose 4.1 mmol/L, alkaline phosphatase 201 U/L; positive hepatitis B surface antigen, e antibody, and core antibody; urine glucose (++), protein (+), microalbumin 70.9 mg/L, α1-micro-globulin 168.0 mg/L, and urine quantitative protein 0.93 g/24 h. Renal dynamic imaging examination showed that the glomerular filtration function was moderately impaired in bilateral kidney. Blood gas analysis showed pH 7.24, partial pressure of carbon dioxide 31 mmHg,and bicarbonate concentration 13 mmol/L. Whole-body bone scan showed multiple bone metabolism active lesions. X-ray screening showed multiple fractures of ribs. Bone mineral density measurement showed severe osteoporosis. Fanconi syndrome and osteomalacia induced by adefovir dipivoxil were diagnosed. Adefovir dipivoxil was replaced with entecavir. Treatments with calcium and phosphate supplement were given. Six days after the above treatments, serum phosphorus level rose to 0.71 mmol/L. The above treatments were continued after the patient was discharged. Half a year later, he could walk with long strides and his serum phosphorus level was 0.81 mmol/L.

  • Zhong Xuli, Zhang Junli
    . 2015, 17(6): 466-467.
    A 9-year-old girl with recurrent urinary tract infection received an IV infusion of latamoxef sodium 1.5 g twice daily. About 2 minutes after the first latamoxef sodium infusion, the girl developed generalized skin flushing and itching, blurred vision, lip cyanosis and chest congestion. Her heart rate was 70 beats/min, blood pressure was 58/27 mmHg and breathing rate was 25/min. Latamoxef sodium was stopped immediately and she was given oxygen inhalation through nasal tube and electrocardiographic monitoring. She was treated with an intravenous bolus of adrenaline 0.3 mg, an intravenous bolus of promethazine hydrochloride 25 mg, an IV infusion of 0.9% sodium chloride injection 500 ml, oral chlorphenamine 8 mg and an IV infusion of methylprednisolone 80 mg. About 1 hour later, her blood pressure was 80-90/41-47 mmHg. Adrenaline 1 μg/(kg·min)via IV pump was given. Two minutes later, her blood pressure increased to 157/78 mmHg and the heart rate was 88 beats/min. Adrenaline was gradually reduced and stopped.
  • Xing Xiaomin, Han Bing, Liu Donghua, Yue Yue, Zhu Li, Leng Ping, Li Jing
    Adverse Drug Reactions Journal. 2025, 27(1): 30-35. https://doi.org/10.3760/cma.j.cn114015-20240516-00348
    In order to promote rational drug use in perioperative period, a perioperative clinical medication pathway system was constructed in the Affiliated Hospital of Qingdao University using the project management method of work breakdown structure (WBS). To establish this system, the following 7 tasks should be completed: requirement investigation of the pathway, formulation of drug usage standards, formulation of clinical medicine pathways, clinical communication and training, effect evaluation and supervision, informazation of medication supervision, and therapeutic drug monitoring, which were implemented by pharmacists of different specialties, respectively. After 4 years of effort, 6 general clinical medicine pathways were completed for antibiotics, analgesics, drugs in venous thromboembolism prophylaxis, nutritional support agents, airway management drugs, and proton pump inhibitors, respectively. These pathways had positive effects in improving the rational use of antibiotics, optimizing the postoperative pain management, and strengthening the risk assessment of thrombosis for patients in the surgical department. The personalized pathway constructed for the Cardiac Surgery Department and the multidimensional pharmaceutical intervention in the Anesthesiology Department also had remarkable effects. In conclusion, the construction of perio- perative medication pathway system through WBS was helpful to refine the division of work tasks, reflect the value of pharmacists, and improve the quality of perioperative pharmaceutical services.
  • Ye Zhen, Lyu Xin, Cai Xiaodan
    Adverse Drug Reactions Journal. 2024, 26(10): 631-633. https://doi.org/10.3760/cma.j.cn114015-20240206-00089
    A 45-year-old male patient with type 2 diabetes mellitus was additionally treated with henagliflozin (10 mg, once daily), enalapril, fenofibrate, finerenone, celecoxib, eperisone and mecobalamin due to poor glycemic control, hypertension, hyperlipidemia and other conditions at previous therapy of insulin aspart 30 and acarbose. Before the additional medication, the patient′s serum creatinine (Scr) and blood urea nitrogen (BUN) were normal., Later, the patient discontinued celecoxib, finerenone, and fenofibrate by himself as relevant symptoms were improved successively. On the 36th day of medication, the patient experienced paroxysmal pain in the lumbar region, which gradually worsened. Then the patient stopped using henagliflozin by himself 2 days later while the other medications remained. The next day, laboratory tests indicated Scr 180 μmol/L and BUN 9.6 mmol/L, and acute kidney failure was diagnosed. Analgesic, antispasmodic and glucocorticoid pulse therapy was administered, and the patient′s lumbar pain was gradually improved. On the 6th day of discontinuing henagliflozin, Scr was 142 μmol/L and BUN was 9.4 mmol/L; on the 9th day, Scr was 113 μmol/L and BUN was 9.1 mmol/L; approximately 3 months after drug discontinuation, Scr was 66 μmol/L and BUN was 6.0 mmol/L.
  • Xun Zhikun, Qian Jiao, Wu Si
    . 2016, 18(4): 312.
    A 60-year-old male patient with hypopharyngeal carcinoma received chemotherapy with docetaxel and nedaplatin. Five minutes after the first treatment with docetaxel (120 mg in 0.9% sodium chloride 500 ml), the patient developed dyspnea, cardiac and breath arrest, and his blood pressure was too low to be measured. The drug was stopped immediately and chest compression, endotracheal intubation, ventilator-assisted breathing, drug therapy such as adrenaline, dexamethasone, and dopamine were given. The patient eventually died after 18.5 hours of rescue.Because the patient did not received any other drugs except docetaxel, it was considered that anaphylactic shock was induced by docetaxel.
  • 讨论与争鸣
    . 2014, 16(6): 356-3.
  • Liu Yuanyuan, Li Rugui, Hu Bo, Li Jinke, Tan Huabing
    . 2018, 20(1): 58.
    A 53-year-old male patient who had a history of pulmonary tuberculosis with fever, hyperhidrosis with slight cough, in other hospital diagnosed as pulmonary tuberculosis, received quadruple anti tuberculosis therapy (isoniazid, rifampicin, pyrazinamide and ethambutol). On the 11th day of therapy, patients developed nasal bleeding and lower extremity ecchymosis petechiae, rapidly expanding to the whole body. On the 13th day, the patient was sent to our hospital, the blood routine examination showed his blood platelet count(PLT)was 1×109/L, the antituberculous drugs were discontinued, and the treatment of raising platelets, anti allergy, hemostasis and anti infection was given. On the 4th day of treatment, the patient′s temperature returned to normal, the nasal bleeding stopped, and PLT was 18×109/L. On the 7th day, his body ecchymosis subside, and PLT was 92×109/L. On the 16th day, his PLT was 151×109/L, and multi-slice spiral CT examination showed right lower lung lesion was absorbed.
  • 病例报告
    Jiang Saiping;Lu Xiaoyang
    . 2011, 13(3): 193-2.
    A 70-year-old man received cefoperazone sodium/sulbactam sodium, vancomycin, and omeprazole for worsened cough and expectoration accompanied by a fever and short of breath. On day 8, he was given citalopram 10 mg once daily for depression. On day 9, his ALT and AST levels increased from 47 U/L and 52 U/L to 139 U/L and 145 U/L, respectively. The dosage of citalopram was increased to 20 mg once daily due to poor control of depression. Subsequently, his hepatic enzyme levels increased markedly and, on day 19, the laboratory tests revealed a ALT level of 529 U/L and a AST level of 256 U/L. Abnormal hepatic function was considered to be induced by citalopram, so citalopram was stopped and other drugs were continued. Then his hepatic function gradually returned to normal.
  • 病例报告
    Kong Feifei;Tan Xingqi;Guo Liangjun
    . 2010, 12(3): 216-2.
    A 65yearold woman received fluvastatin sodium 40mg once daily for decreasing the serum levels of total cholestero1 and triglyceride. Ten days later, the patient developed asthenia and fatigue. One month later, laboratory tests revealed the following levels: AST 434 U/L,ALT 550 U/L,γ-GT 307 U/L,AKP 270 U/L. Fluvastatin sodium was withdrawn immediately. The patient received an IV infusion of glutathione 1.8g in 5% glucose 250mL. After 20 days of therapy, her liver function obviously improved. Her AST and ALT levels decreased to 48U/L and 32 U/L,respectively.
  • 安全信息
    . 2010, 12(5): 374-1.
  • 病例报告
    Yuan Yuan;Li Jianjun;Chen Siyuan;Du Liangjie
    . 2010, 12(6): 435-1.
    A 16yearold boy was undergone a surgery for thoracolumbar vertebra fracture. After operation, he received rivaroxaban 10 mg once daily. His platelet count was 230×109/L before drug administration. However, eight days later, his platelet count increased to 713×109/L. Rivaroxaban was discontinued and changed to SC nadroparin calcium 4 100 IU every 12 hours. His platelet count decreased gradually. Nineteen days later, his platelet count was 284×109/L.
  • 病例报告
    Lü Yu-hong;CHEN Jian
    . 2012, 14(1): 49-2.

    A 48-year-old woman received an IV infusion of sodium valproate 400 mg every 12 hours via a pump for secondary epilepsy. Moxifloxacin, propafenone, and nifedipine were given at same time. On the third day, oral sodium valproate 200 mg thrice daily was added to the regimen. On days 1 to 7 of sodium valproate use, the prothrombin time (PT) was 11.0, 12.9, 12.9, 14.7, 18.5, 23.3, 37.7 s (the result of the second test on day 6), and 41.5 s, respectively. And the activated partial thromboplastin time (APTT) was 30.0, 44.7, 50.9, 43.3, 66.8, 52.6, 65.0 s (the result of the second test on day 6), and 69.0 s, respectively. Sodium valproate was withdrawn immediately and other three medications continued. Two days after drug discontinuation, her PT was 12.9 s and APTT was 41.2 s.

  • 病例报告
    DING Yue-qing;LI Hua;XIE Zhen-qiang;ZHANG Wei-juan;DAI Jun;KONG Jun;WU Hong-jun
    . 2012, 14(2): 111-3.
    A 31-year-old woman with schizophrenia received risperidone 1 mg twice daily. One week later, the dose was increased to 2 mg twice daily. The patient had previously received risperidone intermittent treatment for three times. After a 49-day regular treatment, the psychiatric symptoms relieved. On days 50 to 52, she did not adhere to the instructions of the physician for regular use of the drug. On day 54, the patient experienced profuse sweating with a temperature of 385 ℃. On day 55, she developed disturbance of consciousness, tachycardia, muscle rigidity of the upper limbs, and hypermyotonia. Her electrocardiograph showed sinus tachycardia. Laboratory tests showed the following findings: white blood cell count 12.3×109/L, cholinesterase 13 268 U/L, creatine kinase 1447 U/L. The blood concentrations of risperidone was 70.5 μg/L. Neuroleptic malignant syndrome (NMS) was diagnosed. The medication was stopped immediately. Physical methods for lowering body temperature, fluid supplement, antiarrhythmics, anti-infective therapy, correction of the acid-base imbalance, and liver-protective treatment were given. Six days later, the temperature returned to normal, the NMS symptoms disappeared. After switch to olanzapine therapy, the similar symptoms did not recur.
  • 安全信息
    . 2012, 14(5): 326-1.
  • 病例报告
    XI Yan;XU Li-wen
    . 2012, 14(6): 377-2.
    A 52-year-old man receive IM phenobarbital sodium 0.1 g and IM atropine sulfate 0.5 mg thirty minutes before surgery for mixed hemorrhoids circumcision. One day later, he developed erythema and blister with itch on his thigh, sole, and the back of the hand, as well as red swelling with itch on his pudendum. Three days later, he developed sharp pain on the sole. Fixed drug eruption was diagnosed. The patient was administered an IV injection of 25% glucose 20 ml plus calcium gluconate 20 ml, an IV infusion of 5% glucose and sodium chloride 250 ml plus dexamethasone 10 mg, oral loratadine 10 mg once daily.At the same time,toptical calamine lotion was applied to his affected part. Ten days later, his symptoms disappeared, but pigmentation remained in the area of eruption.
  • JI Bing-xin;SU Li;ZHAO Hong;HUI Wu-han;SUN Wan-ling;XU Juan
    . 2013, 15(3): 132-4.

    To evaluate the efficacy and safety of pretransplant conditioning regimens with intravenous (IV) infusion of busulfan once daily and cyclophosphamide in patients undergoing allogeneic stem cell transplantation allo -HSCT. MethodsThe data of consecutive patients treated with a conditioning regimen with busulfan and cyclophosphamide (Bu/Cy) before undergoing allo-HSCT in Xuanwu Hospital of Capital Medical University from January 2004 to June 2012 were collected and retrospectively analyzed. All patients were divided into the oral group [the inpatients were treated with oral Bu 4.0 mg/(kg·d) for 3 days from January 2004 to June 2006] and the IV infusion group [the inpatients were treated with IV infusion of Bu 3.2 mg/(kg·d) for 3 days from July 2006 to June 2012]. The incidence of adverse reactions, the situation of hematopoietic reconstitution, and survival rate in the two groups were recorded.ResultsA total of 50 patients were collected. Of them, 34 patients were in the IV infusion group and 16 patients were in the oral group. There was no significance differences in gender, age, and numbers of transplanted stem cells between the two groups (P>0.05). The incidence of oral mucositis, gastrointestinal reactions, and liver damage in the IV infusion group were lower than those in the oral group [11.7% (4/34) vs. 43.8% (7/16), 17.6% (6/34) vs. 50.0% (8/16), 20.6%(7/34) vs. 50.0% (8/16), respectively, all P<0.05] Adverse reactions such as hepatic veno-occlusive disease or epilepsy were not found. The hematopoietic reconstitutions were achieved in all patients in the two groups. The time that peripheral blood neutrophil count ≥0.5×109/L and platelet count ≥20×109/L required were (14.3±3.5)d and (15.6±4.0)d, (17.5±5.0)d and (19.0±6.7)d in the IV infusion and the oral groups, respectively. There were no differences between the two groups (P>0.05). The 5-year survival rates were (69.5±12.1)% and (62.5±12.1)% in the IV infusion and the oral groups, respectively. There were no differences between the two groups (P>0.05). ConclusionPretransplant conditioning regimen with IV infusion of busulfan once daily and cyclophosphamide in patients with hematological malignancies and undergoing allogeneic stem cell transplantation is safer than that with oral busulfan and its efficacy is clear.

  • ADR咨询
    . 2000, 2(1): 34-34.
  • WHO信息
    . 2003, 5(6): 420-420.
  • 不良事件
    . 2004, 6(3): 200-200.
  • 国外信息
    . 2005, 7(1): 73-73.
  • 国外信息
    . 2005, 7(5): 393-394.
  • 不良事件
    . 2005, 7(5): 391-391.
  • 病例报告
    . 2006, 8(1): 51-52.
  • 病例报告
    . 2005, 7(6): 454-454.
  • 病例报告
    . 2001, 3(1): 48-48.
  • 病例报告
    . 2003, 5(3): 183-183.
  • 网络医药
    . 2003, 5(2): 107-109.
  • 监测简报
    . 2003, 5(4): 266-267.
  • 监测简报
    . 2003, 5(4): 265-265.
  • ADR监测
    . 2004, 6(4): 263-265.
  • ADR术语
    . 2002, 4(5): 354-356.
  • 病例报告
    . 2006, 8(4): 297-297.
  • 药物安全动态
    . 2006, 8(2): 153-153.
  • ADR术语
    . 2003, 5(1): 64-66.
  • 不良事件
    . 2005, 7(6): 417-417.
  • WHO信息
    . 2002, 4(2): 136-136.
  • 不良事件
    . 2002, 4(4): 272-272.
  • 病例报告
    . 2002, 4(4): 259-259.
  • 不良事件
    . 2002, 4(2): 130-130.
  • 监测交流
    . 2005, 7(4): 301-302.
  • LI Ping;CHEN Yu-wen;LIU Hai-yan
    A 92-year-old male patient with upper gastrointestinal hemorrhage received IV infusions of pantoprazole, compound sodium chloride injection, vitamin K1, water-soluble vitamin, and fat-soluble vitamin (II). Five days later, pantoprazole was withdrawn and changed to an intravenous infusion of esomeprazole 40 mg dissolved in 0.9% sodium chloride 100 ml every 12 hours. Two days later, the patient developed rave, hallucinations, and insomnia. He was given IM diazepam 10 mg. One hour later, the above-mentioned symptoms improved. Esomeprazole was discontinued and other medications remained unchanged. The symptoms of mental disorders did not recur.
  • 病例报告
    ZHOU Ping;LI Yu;JIANG Chang-jun;YU Xiao-gang
    . 2012, 14(6): 389-2.
    A 7-month-old female child developed an abscess on her left upper arm due to BCG vaccination 4 months after birth. She treated with local application of rifampicin capsule powder about 37.5 mg/d for one month, but with no improvement. Laboratory examination showed the following results: alanine aminotransferase 126 U/L, aspartate aminotransferase 106 U/L. The local application of rifampicin capsule powder was stopped, reduced glutathione was given to protect her liver, Wuzhi capsules (五酯胶囊) was given to reduce enzyme level, as well as incision and drainage of the abscess were performed and caseous necrotic tissue was cleared away. Nineteen days later, the child’s lesion on her left upper arm healed, her liver function improved and she was discharged. Her liver function returned completely to normal one and half month after discharge.
  • 安全信息
    . 2012, 14(6): 400-1.
  • ADR系列问答
    . 2011, 13(1): 63-1.
  • 病例报告
    Wu Zhiheng;Yang Bo
    . 2011, 13(3): 185-1.
    A 70-year-old woman was planned to undergo meningeoma resection and received an IV infusion of cefuroxime 2 g dissolved in 250 ml of 0.9% sodium chloride once daily for a lung infection before operation. Her platelet count was 166×109/L before drug administration and, on day 2 of treatment, her platelet count rapidly dropped to 40×109/L, but no evidence of clinical bleeding. It was considered to be associated with cefuroxime, so the drug was withdrawn and switched to ofloxacin. One day after change to ofloxacin, her platelet count rose to 160×109/L. Thereafter, the pulmonary infection improved and the operation completed uneventfully.
  • 病例报告
    Li Ming;Long Haiyan
    . 2011, 13(2): 125-2.
    A 52yearold female patient received combination treatment with levofloxacin, rifamycin sodium, isoniazid, ethambutol and pyrazinamide for pulmonary tuberculosis accompanied by tuberculous pleurisy. On day 13 of treatment, her sputum culture was positive for Enterobacter cloacae. Subsequently, an IV infusion of ceftazidime 2 g in 0.9% sodium chloride 100 ml once daily was added to her regimen. Four days later, the patient experienced confusion and delirious. Levofloxacin was stopped, but his psychiatric symptoms did not improve. Ceftazidime was withdrawn and other drugs continued, her psychiatric symptoms disappeared. Ceftazidime was not administered again and the above symptoms did not reappear. Her psychiatric symptoms did not recur after readministration of levofloxacin.
  • 病例报告
    Zhang Weiwei;Xu Lin;Geng Changxin;Wang Qing
    . 2011, 13(6): 379-2.
    A 49-year-old woman was treated with levofloxacin 500 mg/d for upper respiratory tract infection. On the third day, during infusion of levofloxacin, the patient suddenly presented with nausea, chest discomfort, and suffocation. Levofloxacin was stopped immediately and an IV infusion of 0.9% sodium chloride was given. Subsequently, she experienced agitation, short of breath, headache, crying, and groaning. Meanwhile, she developed numbness and coldness in both upper limbs, followed by holding her upper limbs upright and flexion of her fingers. Oxygen inhalation, psychological counseling, and IM diazepam were given . Ten minutes later, the patient’s emotion returned to stable, and she had eupnea without chest distress and suffocation. She underwent massage therapy for hands. Ten hours later, she gradually recovered.
  • Mei Leilei, Ren Feng, Zhang Weifang, Xiong Lei, Zhang Wuping, Liu Ye
    Adverse Drug Reactions Journal. 2020, 22(12): 689-692. https://doi.org/10.3760/cma.j.cn114015-20200515-00529
    Trimetazidine (TMZ) is a drug that could optimize myocardial energy metabolism and is widely used in the prophylactic treatment of angina pectoris. TMZ-associated Parkinson syndrome accounted for 1.9% (3/155) of drug-induced Parkinson syndrome and 8.4% (161/1-916) of TMZ-related adverse events. The estimated incidence was 0.36/100-000 patient-years. TMZ-associated Parkinson syndrome can occur from 1 month to 7 years after taking the medicine and mainly in 9 to 15 months; its clinical manifestation is similar to that of primary Parkinson disease, but the treatments for them are quite different. Therefore, attention should be paid to the differentiation. Age ≥65 years and combination with stroke are risk factors for TMZ-associated Parkinson syndrome. Patients diagnosed with TMZ-associated Parkinson syndrome should discontinue TMZ immediately and should be forbidden from using the drug for life. The symptoms in most patients can completely disappear or significantly be improved after discontinuation of TMZ and for a few patients with persistent symptoms, dopamine supplements such as levodopa and benserazide hydrochloride tablets could be given appropriately. TMZ is contraindicated in patients who have been diagnosed with Parkinson disease. The mechanism of TMZ-induced Parkinson syndrome may be related to the piperazine core structure, which has the effect of blocking dopamine receptors.
  • 病例报告
    Mao Min;Shao Mingjing;Jia Haizhong;Huang Li;Lu Jin
    . 2014, 16(6): 370-2.
    An 82-year-old male patient with cerebral infarction received an IV infusion of cinepazide maleate 320 mg+0.9% sodium chloride injection once daily for 30 consecutive days. The patient′s neutrophil count (NEUT) was 5.7×109/L before treatments and 2.4×109/L on day 28 of treatments. An interval of 5 days later, cinepazide maleate was given again at the same dosage. On day 6 of second use of cinepazide maleate, the patient′s NEUT decreased to 0.2×109/L. Cinepazide maleate was stopped and mecobalamin (500 μg, twice daily), folic acid (5 mg, once daily), and leucogen (20 mg, twice daily) were given. Two days later, the patient′s NEUT decreased to 0. Recombinant human granulocyte colony stimulating factor 200 μg twice daily was injected subcutaneously. Two days later, the patient′s NEUT increased to 4.5×109/L. The patient received cinepazide maleate combined with 15 kinds of drugs at the same time because he suffered from several kinds of diseases. During 18 months of follow-up, the patient did not take cinepazide maleate again and most other combination drugs were used continuously and neutropenia did not recur. It was considered that cinepazide maleate induced the patient′s acute agranulocytosis.
  • . 2015, 17(4): 320.
  • Xiao Mingzhao
    Adverse Drug Reactions Journal. 2021, 23(8): 393-395. https://doi.org/10.3760/cma.j.cn114015-20210615-00677
    Patient safety is a serious global public health problem. In March 2017, World Health Organization (WHO) released the 3rd global patient safety challenge: Medication Without Harm, called for reducing serious and avoidable drug-related injuries in all countries by 50% in the next 5 years, and formulated a strategic action framework for medication safety at the same time. In June 2019, WHO released 3 technical reports, including medication safety in high-risk situations, medication safety in polypharmacy, and medication safety in transitions of care, so as to promote countries to take effective planning and actions as soon as possible to solve problems in the field of medication safety. In April 2021, WHO held a " Medication Without Harm" network conference, emphasizing that it′s an arduous and long-term work to achieve the goal. In May 2021, WHO issued the global patient safety action plan 2021—2030, which took medication safety as the most important task in the 3rd strategic goal, and put forward 4 actions for this task: actions for governments, actions for health care facilities and services, actions for stakeholder, and actions for the WHO. China′s National Health Commission issued the notice on further strengthening patient safety manage- ment in April 2018, focusing on promoting patient medication safety. The realization of the 3rd global patient safety challenge requires the joint efforts of all countries in the world.
  • Li Jun, Shen Jianghua, Xu Jingyi, Mu Hong
    Adverse Drug Reactions Journal. 2021, 23(8): 445-446. https://doi.org/10.3760/cma.j.cn114015-20210222-00190
    A 75-year-old female patient with diabetes mellitus was scheduled for surgery due to right distal radius fracture. She was given an IV infusion of 5% glucose and sodium chloride injection 500 ml + biosynthetic human insulin injection (Novolin R) 6 U during fasting before operation, and no other drugs were concomitantly used. Her fingerstick glucose was 10.6-mmol/L before the IV infusion. At about 3-minutes of fluid infusion (infused fluid was about 8-ml), the patient suddenly developed chills all over the body and nausea, followed by consciousness loss, no response to verbal stimuli, foam at mouth, convulsions of both upper limbs, and incontinence of urine. Finger-stick glucose was 9.6-mmol/L and hypoglycemic reaction could be ruled out. Electrocardiogram monitoring showed the lowest blood pressure 37/27-mmHg and oxygen saturation 0.40. Anaphylactic shock due to biosynthetic human insulin was considered. Anti-anaphylactic and anti-shock treatments such as intravenous pumping of dopamine and norepinephrine, subcutaneous injection of epinephrine, and intravenous infusion of dexamethasone were given successively. Three hours later, the patient returned to normal.
  • Wen Aidong, Liu Meiyou, Fan Tingting, Ding Likun, Ren Danjun
    Adverse Drug Reactions Journal. 2021, 23(10): 505-507. https://doi.org/10.3760/cma.j.cn114015-20211018-01072
    With the key mechanism of disease occurrence being revealed and rapid development of modern biopharmaceutical technology, more and more biological innovative drugs have been approved for marketing. With more clinical application of innovative biological drugs in recent years, more adverse reactions were reported. Therefore, it is of great significance and urgent in clinic to construct the supervision standard and system for the safe use of biological innovative drugs. At present, the main problems hindering the clinical safety supervision of biological innovative drugs are as follows. Firstly, the mechanism of adverse drug reactions is unclear and there is a lack of specific detection indicators to predict them. Secondly, the study on the relationship of "exposure-clinical efficacy-toxic and side effects" of drugs in vivo is still insufficient, so it is difficult to support the establishment of the rule of "quantity and toxicity" for safe drug use. Thirdly, there is a lack of clinical research evidence in line with the physiological and pathological characteristics of Chinese people, and the ideal randomized controlled trials results of clinical research on new drugs are not enough to support its safe drug use in the real world. Therefore, it is necessary to strengthen the supervision awareness of the clinical safe use, accelerate the process of clinical monitoring research on biological innovative drugs, reveal more scientific evidence of clinical safe use, so as to help the construction of the supervision standards and system for the safe use of biological innovative drugs.
  • Lu Yun, Cao Fang, Tang Zhenghe
    Adverse Drug Reactions Journal. 2025, 27(1): 56-58. https://doi.org/10.3760/cma.j.cn114015-20240318-00177
    A 35-year-old male patient with type 2 diabetes mellitus was treated with metformin and dapagliflozin orally for a long time. Due to poor glycemic control and overweight, the treatment was adjusted to subcutaneous injection of semaglutide 0.25 mg once a week plus 1 metformin and empagliflozin tablet orally twice daily. The patient experienced abdominal bloating and significant satiety after the first dose, which did not attract attention, and metformin and empagliflozin tablets were not discontinued. Three days later, he developed persistent epigastric pain, and laboratory tests indicated blood ketone body (β-hydroxybutyrate) 4.70 mmol/L. Despite treatments with lansoprazole, anisodamine, metoclopramide, and dezocine, the symptoms was not alleviated. Gastrointestinal decompression was perfor- med, which led to a slight improvement in abdominal pain. An immediate abdominal CT scan revealed gastric retention. The patient′s gastric retention was considered to be associated with the administration of semaglutide. The following day′s laboratory tests indicated carbon dioxide combining power 2.36 mmol/L, suggesting the occurrence of diabetic ketoacidosis, which was hypothesized to be related to empagliflozin. The original hypoglycemic regimen was discontinued, insulin pump therapy was given with blood glucose level monitoring, and fasting, gastrointestinal decompression, fluid resuscitation, and acid suppression was applied. The patient′s symptoms were significantly improved, and the ketone body levels gradually decreased. After 3 days of treatments, the patient began to eat, and after 6 days, he returned to a normal diet without further abdominal pain or bloating. The ketone body levels and carbon dioxide combining power returned to normal, and the hypoglycemic regimen was adjusted to lispro insulin plus acarbose.
  • Kong Fang, Zhao Yi, Liao Qiuju, Su Li, Huang Xu, Yu Naichang, Li Xiaoxia
    . 2015, 17(4): 297.
    A 41-year-old woman with systemic lupus erythematosus (SLE) took 10 mg dydrogesterone orally twice daily for 7 days for endometrial hyperplasia.Four days after dydrogesterone administration, she developed red maculopapule on her face. She took dydrogesterone at the same dosage for 14 days for second month and developed more severe rashes and generalized exanthematous pustulosis. Active SLE, infections, intoxication or tumors were excluded by lab examinations and SLE disease activity index scores and autoimmune progesterone dermatitis induced by dydrogesterone was diagnosed. Dydrogesterone was stopped and antianaphylaxis treatment was given. Two months later, her symptoms improved gradually and no skin rash was found at 3-month follow-up.
  • Tang Lian, Zhuang Zhiwei, Zhao Fuli, Yang Chen, Shang Erning
    . 2015, 17(2): 126-129.
    ObjectiveTo compare the influence of carbapenems such as biapenem and meropenem on valproic acid (VPA) blood concentration.MethodsThe clinical data of patients with symptomatic epilepsy and infections who were hospitalized in Suzhou Municipal Hospital during January 2008 to December 2013, and received concomitant therapy with VPA and biapenem or meropenem were collected and analyzed retrospectively. These patients were divided into biapenem group and meropenem group. The information of general clinical data and medication were recorded. VPA blood concentration, seizures and clinical treatment before and after the combination with carbapenems were compared between the two groups.ResultsA total of 79 cases were enrolled in the analysis. Six patients were treated with meropenem and biapenem successively at more than one month intervals, clinical data during the period of different carbapenems use were included in different groups. There were 37 cases in the biapenem group and 48 cases in the meropenem group; clinical data had no statistical significance between the 2 groups. The VPA blood concentration of biapenem group and meropenem group were significantly decreased. The VPA blood concentrations in biapenem group were higher than that of meropenem group(13.3±6.2)mg/L vs(10.7±7.0)mg/L, P= 0.046). The mean decrease of VPA blood concentrations in biapenem group was also less than that of meropenem group(70.6±9.6% vs 78.8±8.8%,P=0.010). The VPA blood concentrations of six patients treated with meropenem and biapenem successively were significantly decreased. The blood concentrations were also higher when combined with biapenem compared to meropenem. The rate of seizures had no significant difference between the 2 groups (29.7% vs 35.4%, P=0.749). ConclusionsBoth biapenem and meropenem could decrease VPA blood concentrations significantly. Biapenem had less impact on VPA blood concentration compared to meropenem, but also increased the risk of seizures.
  • Ni Hua, Yuan Yong, Liu Hui, Ni Wenjing, Xu Wenjin
    . 2017, 19(4): 296.

    A 56-year-old male patient received sodium valproate 0.5 g/d for prevention of epilepsy because of postoperative cerebral hemorrhage. Thirty-six days later, the results of reexamination showed the following values: white blood cell (WBC) 3.3×109/L, red blood cell (RBC) 3.2×1012/L, hemoglobin (Hb) 100 g/L, platelet count (PLT) 94×109/L. He did not receive any treatments and continued to take sodium valproate at the same dose. One hundred and two days later, the results of reexamination showed the following values: WBC 1.9×109/L, RBC 3.2×1012/L, Hb 90 g/L, PLT 82×109/L. He was diagnosed with 3 lineage pancytopenia. Sodium valproate was withdrawn. The results of reexamination 13 days later showed the following values: WBC 4.3×109/L, RBC 3.5×1012/L, Hb 100 g/L, PLT 109×109/L.

  • Qusang Zhuoma, Nima Ciren, Liu Junjie, Qiao Jin
    . 2017, 19(3): 235.
    A 48-year-old female patient took oral compound paracetamol tablets(II) 3 tablets for pain due to cold. She developed skin rash on her trunk accompanied by pruritus after 4 hours. Four days later, swelling, ulceration, and fever appeared on her whole body skin. The next day, she developed large area of the oral mucosal erosion, scattered erythema and flaccid blisters on her face, body, arms and legs, and partial exfoliation. The result of examination of Nikolsky′s sign was positive. Laboratory test showed the following values: white blood cell 8.1×109/L, neutrophils 0.76, platelet count 45×109/L, red blood cell 6.51×1012/L, alanine aminotransferase 161 U/L, aspartate aminotransferase 155 U/L, total protein 45 g/L, albumin 28 g/L, and globulin 17 g/L. The patient was diagnosed as epidermolysis bullosa, thrombocytopenia, and drug-induced liver injury. She was treated with oral loratadine 10 mg once daily, IV infusion of 10% calcium gluconate 20 ml, and dexamethasone 15 mg once daily. On day 5, the skin lesions relieved and dexamethasone was reduced to 10 mg once daily. An IV infusion of ceftazidime 2.0 g twice daily was given. On day 8, the oral mucosa erosion disappeared and skin rashes gradually subsided, the temperature declined to normal. The result of reexamination showed platelet count 225×109/L, alanine aminotransferase 92 U/L, aspartate aminotrans-ferase 45 U/L.
  • Wang Bing, Sun Xiaoyan, Li Jinfeng, Zhang Yuan
    Adverse Drug Reactions Journal. 2020, 22(2): 115-117. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.014
    A 71-year-old male patient, who was admitted to hospital for hypertension and coronary artery heart disease, received an IV infusion of Xuesaitong for injection 800 mg dissolved in 250 ml of 0.9% sodium chloride injection once daily. His liver function was normal before treatment. On day 3 of treatment, the patient developed anorexia, epigastric discomfort, and rash. Laboratory tests showed that the alanine aminotransferase (ALT) was 490 U/L, aspartate aminotransferase (AST) was 657 U/L, total bilirubin (TBil) was 33.4 μmol/L, direct bilirubin (DBil) was 10.3 μmol/L, and alkaline phosphatase (ALP) was 51 U/L. The next day, the patient developed jaundice. The laboratory tests showed ALT 2 597 U/L, AST 2 647 U/L, TBil 74.6 μmol/L, DBil 24.3 μmol/L, ALP 58 U/L, prothrombin activity (PTA) 20%, and international normalized ratio 2.4. It was diagnosed as severe liver injury and was related to Xuesaitong for injection. The drug was stopped and liver-protective treatments such as polyene phosphatidylcholine injection and isoglycyrrhizic acid magnesium injection were given. One week later, the patients′ liver function improved (ALT 785 U/L, AST 653 U/L, TBil 46.0 μmol/L, ALP 44 U/L, and PTA 42%). He was transferred to another hospital. At 7 days of follow-up, the rash disappeared and laboratory tests showed ALT 433 U/L, AST 372 U/L, TBIL 35.2 μmol/L, DBIL 10.1 μmol/L, and ALP 48 U/L. No follow-up was continued after then.
  • . 2018, 20(1): 42.
  • 药害事件史话
    . 2011, 13(5): 331-3.
  • 安全信息
    . 2011, 13(3): 146-1.
  • 病例报告
    XU Zhi-ying;CAO Ying
    . 2012, 14(5): 314-2.
    A 19-year-old man with tuberculosis was hospitalized due to massive hemoptysis. On the day of admission, examination of the patient showed blood electrolyte concentrations as follows: potassium 3.5 mmol/L, sodium 137 mmol/L, and chlorine 104 mmol/L. Phentolamine mesilate 20 mg and pituitrin 24 U in 0.9% sodium chloride 50 ml was continuously infused at a rate of 5 ml/h via pump every day. At the same time, he was given anti-TB treatment including isoniazid aminosalicylate, levofloxacin, and amikacin. On day 5 of admission, the patient developed weak and headache. Electrolyte tests showed the following levels: potassium 3.1 mmol/L, sodium 122 mmol/L, chlorine 88 mmol/L, phosphorus 0.65 mmol/L. Pituitrin was reduced to 18 U once every 12 hours. Meanwhile electrolyte supplementation was given and other medications remained unchanged. On day 6, electrolyte tests revealed a potassium level of 2.8 mmol/L, a sodium level of 117 mmol/L, a chlorine level of 83 mmol/L, a phosphorus level of 0.54 mmol/L, and a calcium level of 1.99 mmol/L. Pituitrin was stopped and electrolyte supplementation was given. On day 10 of admission, laboratory tests showed the above-mentioned electrolyte levels returned to normal range as follows: potassium 4.3 mmol/L, sodium 136 mmol/L, chlorine 101 mmol/L,calcium 2.17 mmol/L, and phosphorus 0.82 mmol/L.
  • 会议纪要
    . 2012, 14(3): 202-3.
  • ADR咨询
    . 2002, 4(3): 210-210.
  • ADR咨询
    . 2006, 8(1): 74-74.
  • 病例报告
    . 2004, 6(1): 43-44.
  • 不良事件
    . 2005, 7(1): 69-69.
  • 中毒救治
    . 2005, 7(4): 275-276.
  • 监测简报
    . 2003, 5(6): 411-412.
  • ADR术语
    . 2002, 4(2): 139-141.
  • 病例报告
    . 2002, 4(3): 158-158.
  • 不良事件
    . 2004, 6(2): 130-130.
  • 不良事件
    . 2003, 5(1): 55-55.
  • 病例报告
    . 2005, 7(6): 451-452.
  • WHO信息
    . 2002, 4(5): 352-352.
  • 病例报告
    . 2002, 4(6): 373-373.
  • 国外文献题录
    . 2004, 6(4): 273-274.
  • 病例报告
    . 2005, 7(4): 262-262.
  • 病例报告
    . 2005, 7(4): 274-274.
  • ADE简报
    . 2001, 3(3): 203-203.
  • 病例报告
    . 2001, 3(2): 92-92.
  • 不良事件
    . 2003, 5(4): 268-268.
  • 病例报告
    . 2003, 5(3): 192-192.
  • 不良事件
    . 2004, 6(5): 344-344.
  • 不良事件
    . 2006, 8(1): 65-65.
  • 病例报告
    . 2006, 8(2): 126-126.
  • 药物滥用
    . 2006, 8(2): 120-120.
  • 药物评介
    . 1999, 1(1): 58-59.
  • 不良事件
    . 2002, 4(3): 177-177.
  • 不良事件
    . 2005, 7(5): 389-389.
  • 病例报告
    . 2002, 4(5): 335-336.
  • 不良事件
    . 2005, 7(4): 244-244.
  • 不良事件
    . 2005, 7(4): 271-271.
  • 综合报道
    . 2001, 3(4): 235-237.
  • 不良事件
    . 2003, 5(1): 17-17.
  • 不良事件
    . 2004, 6(1): 56-56.
  • 不良事件
    . 2004, 6(1): 54-54.
  • 药物评介
    . 1999, 1(2): 126-127.
  • 安全信息
    . 2010, 12(2): 148-2.
  • ADR系列问答
    . 2010, 12(1): 72-2.
  • LI Xiao-xiao;LIANG Jun-cheng;SUN Li;HAO Wei;LI Jing;DENG Yan-ping
    ObjectiveTo investigate the hepatic function condition and influencing factors in opioid addicts during rehabilitation after detoxification.MethodsOpioid addicts abstained from opioid in duration of rehabilitation were recruited from Shanghai, Sichuan and Henan Compulsory Isolated Detoxification Center. The subjects′demographics, drug abuse histories, and withdrawal symptoms were recorded. The protracted withdrawal symptoms scale, Hamilton Anxiety scale (HAMA), and Hamilton Depression scale (HAMD) were used to assess withdrawal symptoms. Hepatic function tests including alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin (TBil) were performed at baseline (the 15th day after detoxification), 4th, 12th, 18th, and 24th weeks of rehabilitation.ResultsA total of 130 subjects were enrolled into the study, comprising 106 (81.5%) male and 24 (18.5%) female with average age of (43.8±15.3) years. Their duration of drug abuse was (83.2±4.9) months ranging from 1 to 242 months and average daily dose taken during the last week before abstinence was (1.02±0.09) g ranging from 0.10 to 6.00 g. At the beginning of rehabilitation, the protracted withdrawal symptoms scale averaged (20.2±0.9) ranging from 10 to 52, HAMD averaged (13.7±0.6) ranging from 4 to 41, and HADA averaged (12.3±0.5) ranging from 4 to 31. The initial percentage of abnormal ALT, AST, and TBil in the subjects were 22.3% (29 cases), 9.9% (8 cases), and 2.3% (3 cases), respectively. Compared with the baseline, the percentage of cases with abnormal ALT increased to 36.8% at the 4th week of rehabilitation (P<0.01) and then fluctuated and dropped to 16.7% at the 24th week. The change between the 4th and the 24th weeks was statistically significant (P<0.01). The percentage of cases with abnormal AST showed a trend of increase at the 4th week and then fluctuated and reduced to 4.9% at the 24th week. The percentage of cases with abnormal TBil at the 12th week was 8.4%, which was much higher than that at the baseline and the 4th week of rehabilitation (all P<0.05), and rapidly decreased to zero at the 24th week. The number of subjects who had clinically significant decrease in ALT levels increased from 7 cases (5.6%) at the 4th week to 10 cases (16.7%) at the 24th week, while the number of subjects who had clinically significant increase in ALT levels was decreased from 16 cases (12.8%) to 2 cases (3.3%) at the same time. The risk for abnormal ALT levels in the patients with graver withdrawal symptoms at the beginning of rehabilitation was 0.907 times higher than that with lighter withdrawal symptoms. The risk of abnormal ALT levels in the female patients was 4.51 times higher than that in the male patients. The risk of abnormal ALT levels in patients with severe depression was 1.12 times higher than that with lighter depression during 24 weeks of rehabilitation (OR were 4.51 and 1.12, respectively).ConclusionsThe levels of hepatic function parameters in opioid addicts may be abnormally increased during initial rehabilitation and may improve gradually with prolongation of rehabilitation. Continuous monitoring of hepatic function of opioid addicts should be performed and it is a good strategy for both rehabilitation and prevention of relapse.
  • 安全信息
    . 2011, 13(5): 337-1.
  • 安全信息
    . 2012, 14(1): 14-1.
  • 病例报告
    Xu Ruiling;Wu Guoxian
    . 2010, 12(6): 440-2.
    Two elderly women, aged 80 and 74 years, received an IV infusion of amoxicillin/sulbactam 6.0 g in 0.9% sodium chloride 250 mL once daily for acute attack of chronic bronchitis and skin infection, respectively. Patient 1 experienced urinary frequency, urodynia, dysuria, gross hematuria and 24hour urine volume was about 400 mL the next day. Laboratory tests showed the following values: urine protein (+), occult blood (+++), BUN 8.48 mmol/L, SCr 380 μmol/L. Amoxicillin/sulbactam was stopped and changed to lincomycin. Renal function protective, symptomatic, and supportive treatments were also given. Fifteen days later, her 24hour urine volume was 1 500 mL, her BUN level was 5.86 mmol/L, her SCr level was 116 μmol/L, and routine urine tests were normal. Patient 2 was presented with nausea, vomiting, lumbago, hematuria, three+urine protein and two+occult blood after infusion completion. Amoxicillin/sulbactam was withdrawn and switched to lincomycin. Her conditions did not resolve and 24hour urine volume was less than 200 mL. Her BUN level was 11.45 mmol/L and SCr level was 467 μmol/L. Hemodialysis was performed, lincomycin was continued and supportive and symptomatic treatments were given. Ten days after treatments, her urine volume increased gradually. Twentytwo days later, the 24hour urine volume was 1 200 mL. Meanwhile BUN level and SCr level were respectively 7.83 mmol/L and 141 μmol/L, routine urine tests was within normal range.
  • Li Xiaoling1, Zhao Simiao1, Wang Yawei1, et al
    Adverse Drug Reactions Journal. 2019, 21(1): 20-29. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.005
    ObjectiveTo preliminarily understand the current status of medication safety management of medical institutions in China.MethodsMedication Safety Panel in China Core Group of International Network for the Rational Use of Drugs (INRUD) and Chinese Pharmacological Society Professional Committee of Drug-induced Diseases jointly established a research group. Basing on the voluntary principle, members (medical institutions) of the group did medication safety self-assessment using the questionnaires of "2011 ISMP Medication Safety Self Assessment for Hospitals (Chinese version)", which included 10 key elements, 20 core indicators, and 270 assessment projects. The questionnaires were handed out on August 17, 2018 and needed to be completed and submitted within 2 months.ResultsAs of October 19, 2018, 67 hospitals of 16 provincial administrative regions in total had submitted their questionnaires, including 61 (91.0%) 3A hospitals and 6 (9%) 2A hospitals. The average value of total scores of medication safety self-assessment in the 67 hospitals was 58.9% (7.6%-90.0%). None of the 67 hospitals evaluated the key element Ⅵ(medication device acquisition, use, and monitoring). The scores of the other 9 key elements from high to low were 67.6%, 66.2%, 65.1%, 64.8%, 64.1%, 58.2%, 54.5%, 54.4%, and 52.5% respectively for element Ⅶ (environmental factors, workflow and staffing patterns), element Ⅳ(drug labeling, packaging and nomenclature), element Ⅸ (patient education), element Ⅲ(communication of drug orders and other drug information), element Ⅷ (staff competency and education), element Ⅴ(drug standardization, storage and distribution), element Ⅹ (quality processes and risk management), element Ⅰ (patient information), and element Ⅱ (drug information).ConclusionThe data of medication safety from 67 hospitals of 16 provincial administrative regions were obtained through the first national self-assessment questionnaire survey in medical institutions, which initially reflected the current status of medication safety in medical institutions in China.
  • Ye Zhen, Luo Fuliang, Ma Shuangshuang, Cai Lun, Cao Shengkun, Tong Deyin
    . 2017, 19(5): 387.
    A 70-year-old male patient received ticagrelor 90 mg twice daily and aspirin 100 mg once daily as dual antiplatelet therapy after operation for coronary stent implanting. On day 2 of treatment, he developed traces of blood in sputum. The hemoptysis became worse and times became more after that. On day 42, the patient developed massive hemoptysis about 100 ml. Ticagrelor was discontinued by himself. The patient then was given oxygen inhalation, expectorant drug and hemostatic agents. Anticoagulant therapy was adjusted for the combined use of clopidogrel 75 mg once daily and aspirin 100 mg once daily. On day 4 of the ticagrelor withdrawal, the amount of hemoptysis was obviously reduced. On day 7, the hemoptysis ceased.
  • Shi Yang, Xu Lishan, Zeng Zhaogang, Zhang Wei, Zhou Haixia, Fan Dengfeng
    . 2017, 19(5): 395.
    Two female patients (patient 1: 41 years old, patient 2: 61 years old) received oxycodone-acetaminophen tablets orally at a dose of 330 mg every 6 hours daily for postoperative analgesia. Their hepatic functions were normal before the drug administration. Their liver enzymes levels were increased 2 days and 1 day after drug administration (case 1: ALT 471 U/L, AST 710 U/L, ALP 114 U/L, γ-GT 222 U/L, case 2: ALT 154 U/L, AST 96 U/L, ALP 164 U/L, γ-GT 210 U/L). In addition, case 1 developed the symptoms of dizziness, headache, nausea and vomiting. The two patients stopped the drug on day 2 and 4 after the appearance of hepatic lesion, respectively. They received liver protection therapy which included IV infusion of vitamin C and vitamin B6, polyene phosphatidyl choline capsules, glucuronolactone tablets and silibinin capsules by oral administration. The results of reexamination 20 days after drug withdrawal in patient 1 showed ALT 14 U/L, AST 17 U/L, ALP 32 U/L, and γ-GT 30 U/L. The results of reexamination 21 days after drug withdrawal in patient 2 showed ALT 23 U/L, AST 26 U/L, ALP 87 U/L, and γ-GT 55 U/L.
  • He Bin, Yang Yufei, Li Peihong, Zhang Juan, Yang Yang, Tong Yonghong, Wei Qing, Wang Weiguo, Zhang Qingyuan, Bie Jun, Chen Wenju, Hao Rutian, Wang Na, Liu Zhongguo, Yang Hui, Xie Shengyang, Yang Zhong
    . 2017, 19(3): 187.
    ObjectiveTo understand the adverse reactions of Kanglaite injection and its incidence and explore the factors affecting the safety of Kanglaite Injection in clinical use. MethodsA non-interventional and prospective hospital based monitoring study and nested case-control study were conducted. All hospitalized cancer patients receiving Kanglaite injections from 28 hospitals in northeast, north, central, east, south, southwest, northwest regions of China from September 2013 to September 2014 were enrolled in this study. The main monitoring contents included the general status of patients, the drug administration (including indications and combined  use), medication safety, and so on. Patients developing adverse reactions related to Kanglaite injection distributed in the case group and patients who did not develop adverse reactions were randomly selected and distributed into the control group with a ratio of 1 ∶  3, and the factors that affect the safe use of Kanglaite injection were analyzed.ResultsA total of 5 022 cancer patients were entered into the study, including 2 926 males and 2 096 females with age from 9 to 95 years and their average age was (60±12) years. The top five tumors were lung cancer (1 456 patients, 28.99%), intestinal cancer (867 patients, 17.26%), mammary cancer (372 patients, 7.41%), gastric cancer (346 patients, 6.89%), and liver cancer (335 cases, 6.67%). There were 3 863 patients (76.92%) with tumor stage III and IV, 348 patients with allergic history (6.93%); 2 524 patients were complicated with other diseases (50.26%); 4 687 patients (93.33%) had combined drug therapy. During the monitoring period, 751 (14.95%) of 5 022 patients developed adverse events and of them, 18 cases met the criteria of causality of adverse reactions, including 7 cases of phlebitis, 3 cases of nausea and vomiting, 3 cases of chills, 2 cases of rash, 1 case of palpitation, 1 case of transaminase increase, and 1 case of fever. The incidence of adverse reactions was 0.36%. Univariate analysis showed that the incidence of adverse reactions in patients with combined diseases was higher than that in patients without combined diseases (χ2=5.4723, P=0.019), the incidence of adverse reactions in patients with combined western medication was higher than that in patients with combined western and Chinese medication(P=0.002). Logistic regression analysis showed that the influencing factors of adverse reactions were coexisting diseases (OR=1.636, 95%CI: 1.100-2.433, P=0.013) and combined medication (OR=1.475, 95%CI:1.108-1.965, P=0.027). Nested case-control study showed that the influencing factors of adverse reactions induced by Kanglaite injection were radiotherapy (OR=1.864, 95%CI: 0.930-3.736, P<0.01) and combined medication (OR=1.622, 95%CI: 1.102-2.389, P<0.01). ConclusionsThe incidence of adverse reactions of Kanglaite injection in clinical application is lower and the safety is good. Coexisting diseases, combined medication and radiotherapy are main factors affecting its clinical safety.
  • Song Haixia, Qin Qin, Yuan Caixia, Fan Lingling, Li Hong
    Adverse Drug Reactions Journal. 2022, 24(2): 110-112. https://doi.org/10.3760/cma.j.cn114015-20210601-00620
    A 38-year-old female underwent in vitro fertilization and embryo transfer for bilateral tubal obstruction secondary infertility. Seven days after embryo implantation, the patient developed severe nausea, vomiting, and vertigo. Human chorionic gonadotropin test in blood was positive, so the woman was diagnosed as having biochemical pregnancy and early pregnancy reaction. After symptomatic treatment, the symptoms of vertigo were not improved and gradually aggravated. Intramuscular injection of diphenhy- dramine 20-mg was given at 3+2 weeks of gestation. Then the symptoms were relieved. At 24 weeks of gestation, the patient was diagnosed as having twin pregnancy and cleft lip in twin fetus, and fetus cleft palate could not be excluded. After the above diagnosis was confirmed at 28 weeks of gestation, induction of labor was performed in the patient. Both fetuses were found to have severe cleft lip and palate, and no other appearance of deformities was found. It was considered that the cleft lip and palate deformity in the twin fetus might be related to diphenhydramine exposure during pregnancy.
  • Li Dekun
    Adverse Drug Reactions Journal. 2023, 25(5): 257-262. https://doi.org/10.3760/cma.j.cn114015-20221031-01002
    In 2021, the National Medical Products Administration issued the“Good Pharmacovigilance Practice”(GVP), which required the marketing authorization holders to establish and continuously improve pharmacovigilance system and to carry out pharmacovigilance activities in a normalized manner. Traditional Chinese medicine was the unique variety in China. Due to its high risk in clinical application, more attention should be paid to the overall planning and coordination of various aspects in the pharmacovigi- lance, especially for the traditional Chinese medicine injections. Thus by consulting regulations and literature, the possible ideas and suggestions such as establishing organizational structure and equipping professional personnel, improving regulations and systems, streamlining information collection channels, and identifying and evaluating risk signals, etc. were proposed for traditional Chinese medicine injection enterprises in carrying out pharmacovigilance.
  • Ma Jingyue, Wang Huiping
    Adverse Drug Reactions Journal. 2023, 25(6): 366-370. https://doi.org/10.3760/cma.j.cn114015-20220510-00410
    Paradoxical reactions related to biological agents refers to the contradictory phenomenon that occurs during the treatment of biological agents, which is contrary to the treatment purpose or exacerbates the condition of the treated disease. The first biological agent reported to trigger paradoxical reactions is TNF-α inhibitors, which appeared firstly in the treatment of patients with rheumatic diseases, followed by psoriasis and inflammatory bowel diseases. Other types of biological agents such as interleukin (IL) 12/23 inhibitor ustekinumab and IL-17 inhibitors secukinumab and ixekizumab can also cause paradoxical reactions. The mechanism of paradoxical reactions related to biological agents in the treatment of psoriasis, the occurrence and clinical manifestations of common paradoxical reactions (paradoxical psoriasis, arthritis, inflammatory bowel disease, hidradenitis suppurativa, etc.), and the management principles of paradoxical reactions related to biological agents in the treatment of psoriasis are reviewed in this article.
  • Jiang Ying, Zhang Ningping, Xu Qing, Lyu Qianzhou, Gao Hong, Liu Tianshu, Li Xiaoyu
    Adverse Drug Reactions Journal. 2023, 25(2): 76-82. https://doi.org/10.3760/cma.j.cn114015-20220608-00496
    Objective To explore the occurrence of programmed cell death 1 receptor (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitor-related liver injury and the influencing factors in patients with extrahepatic primary tumors. Methods The electronic medical records of patients with extrahepatic primary tumors who were treated with PD-1/PD-L1 inhibitors in Zhongshan Hospital, Fudan University from January to July 2021 were collected and retrospectively analyzed. Patients with PD-1/PD-L1 inhibitor-related liver injury were screened out, and the occurrence time, clinical type, and severity of liver injury were statistically recorded and analyzed. Patients were divided into liver injury group and non-liver injury group according to whether liver injury occurred. Clinical characteristics including age, gender, type of primary tumor, underlying disease, liver metastasis, regimen of PD-1/PD-L1 inhibitor therapy, combined medication, and baseline liver and renal function were compared between the 2 groups. The influencing factors of liver injury were analyzed by multivariate logistic regression method, and the odds ratio (OR) and 95% confidence interval (CI) were calculated. Results A total of 386 patients were included in the analysis and 29 patients had PD-1/PD-L1 inhibitor-related liver injury, with an incidence of 7.5%. Of the 29 patients, 25 were male and 4 were female, aged from 19 to 90 years. PD-1/PD-L1 inhibitors used were sintilimab, nivolumab, teriprizumab, pembrolizumab, tislelizumab, atezolizumab, camrelizumab, and durvalumab in 7, 5, 5, 4, 3, 3, 1, and 1 patient, respectively. The median time from drug use to the occurrence of liver injury was 44 (24, 112) days. The liver injury were typed as hepatocellular injury in 8 patients, cholestatic liver injury in 17 patients, and mixed type in 4 patients, and the severity was grade 1 in 19 patients, grade 2 in 7 patients, and grade 3 in 3 patients. After diagnosis of liver injury, all 29 patients were given symptomatic treatments, of which 24 patients discontinued PD-1/PD-L1 inhibitors; 21 patients had recovered liver function after 6-71 days, and 8 developed chronic hepatitis. Multivariate logistic regression analysis showed that hepatitis virus infection (OR=5.749, 95%CI: 1.337-24.719, P=0.019), hypertension (OR=5.345, 95%CI: 2.034-14.047, P=0.001), and baseline alkaline phosphatase (ALP) ≥125-U/L (OR=4.651, 95%CI: 1.728-12.521, P=0.002) were independent risk factors for PD-1/PD-L1 inhibitor-related liver injury. Conclusions Liver injury is a common adverse reaction of PD-1/PD-L1 inhibitors, and cholestatic liver injury is the most common clinical type. Patients with hepatitis virus infection, hypertension, and elevated baseline ALP are at high risk for developing PD-1/PD-L1 inhibitor-associated liver injury.
  • Chu Yanqi, Liu Chen, Jiang Jiaqi, Pei Tong, Wang Zhizhou, Yan Suying
    . 2017, 19(5): 335.
    ObjectiveTo explore the clinical characteristics of desogestrel and ethinylestradiol contraceptive tablets induced cerebral venous sinus thrombosis (CVST).MethodsFive cases with desogestrel and ethinylestradiol contraceptive tablets induced CVST, including 4 cases from Xuanwu Hospital of Capital Medical University and 1 case from domestic literature report, were collected and analyzed.ResultsThe age of the 5 patients was 19-49 years old, and the average age was (37±12) years. One case was overweight. Causes for using drugs were respectively functional uterine bleeding (3 cases), menstrual disorder (1 case) and contraception (1 case), dosage was 1 tablet once daily (take 21 d, stop 7 d, and start the next cycle). One case had overdose before onset (8 tablets). The duration of the drug use was 27 d to 5 years (27 d, 50 d and 2, 3, 5 years). The patients all developed headache (3 cases had severe head pain), consciousness disorder (4 cases), nausea and vomiting (3 cases), and secondary epilepsy (1 case). The results of 5 cases of Naranjo score≥ 7, namely, the correlation between desogestrel and ethinylestradiol tablets with CVST was highly likely. Of four patients admitted to Xuanwu Hospital of Capital Medical University length of stay for 10-40 d, after the intracranial venous sinus thrombectomy, embolectomy and anticoagulant therapy, 1 case fully recovered, 1 case had left limbs dyskinesia, 1 case had legacy dysarthria, and 1 case shifted from coma to lethargy (the patient could open eyes autologously). The case from domestic literature was hospitalized for 30 d, and recovered after anticoagulation treatment.ConclusionsThe initial symptoms of CVST were non-specific due to the use of desogestrel and ethinylestradiol contraceptive tablets. The patients who had headache after taking the drugs should be considered about CVST and should be screened for the diagnosis as soon as possible. It is better to stop the medicine in time and receive treatment for the adverse effects.
  • Fang Wentong, Luo Can
    . 2015, 17(4): 313.
    A 62-year-old male patient received an IV infusion of cetuximab (cycle 1: 716 mg, cycle 2-34: 447.5 mg) once weekly since July 19th, 2012 for postoperative anastomotic recurrence of rectal cancer and liver metastasis. Blood magnesium was 0.35 mmol/L and other electrolyte levels, biochemical indexes, aldosterone level, thyroid function tests, blood routine, urine routine and stool routine tests were normal when he was admitted to hospital on March 28, 2013. Review patients′ medical records, blood magnesium level was gradually reduced and accompanied with the application of cetuximab, blood magnesium was 0.51 mmol/L on January 31, 2013. It was considered that the cetuximab induced hypomagnesemia. An intravenous infusion of magnesium sulfate 10 ml plus 0.9% sodium chloride 500 ml once daily was given. On day 3, the blood magnesium was 0.54 mmol/L, and cetuximab 447.5 mg was given, he was discharged. Magnesium sulfate was given in outpatient clinic. Eight days later, his blood magnesium was 0.82 mmol/L.
  • 病例报告
    Li Lu;Song Hongsong;Cai Haodong
    . 2014, 16(1): 52-2.

    A 63-year-old man with hepatitis B and cirrhosis received oral adefovir dipivoxil 10 mg once daily. About three and a half years after the start of the drug therapy, the patient developed numbness and weakness of lower limbs. He experienced unstable walking in the forth years. Laboratory tests revealed a serum phosphate level of 0.37 mmol/L. Electromyogram showed deep sensory pathway conduction block of bilateral lower limbs. The spinal cord diseases complicated with peripheral neuropathy was considered. After treatment with vitamin B1 and B12, the patient improved. About two months later, the symptoms of lower limb numbness and weakness relapsed. Urinalysis showed alpha 1-microglobulin 257.8 mg/L, microalbumin 168 mg/L and N-acetyl beta-D-glucosaminidase 90 U/L. Bone mineral density examination revealed osteopenia. The patient was diagnosed with Fanconi syndrome related to adefovir dipivoxil. Adefovir dipivoxil was stopped and his therapy was switched to oral entecavir 0.5 mg once daily. At the same time, he was given multivitamin and minerals tablets and calcitriol. Eighteen days later, the serum phosphate level rose to 0.75 mmol/L and the degrees of lower limb weakness relieved. Five months later, he walked normally. Repeat laboratory tests showed the following levels: urine alpha 1-microglobulin 32.8 mg/L, microalbumin 14 mg/L, N-acetyl beta-D-glucosaminidase 15 U/L, and serum phosphate 0.90 mmol/L.

  • Song Yu, Lu Ya, Yang Xueqin, Kang Xuan, Wang Qi, Shen Huiqin
    A 50-year-old female patient with hepatitis B cirrhosis received oral lamivudine (100 mg/d) 8 years ago. Lamivudine resistance appeared one year after the administration. Then adefovir dipivoxil 10 mg/d was added. About 6 years after the combined antiviral treatments, weakness of lower limbs appeared and gradually worsened. At following one year, the patient successively presented with right hypochondrium pain accompanied by difficulty in turning over, limited movement of the lower extremities, and left hypochondrium pain. Laboratory tests showed serum phosphorus 0.55 mmol/L, serum calcium 2.13 mmol/L, and serum uric acid 98  mol/L. Fanconi syndrome (FS) was considered. Adefovir dipivoxil and lamivudine were discontinued and changed to tenofovir disoproxil (300 mg every other day). After one month of treatment, laboratory tests showed serum phosphorus 0.65 mmol/L, serum calcium 2.25 mmol/L, serum uric acid 109  mol/L, urine pH 6.00, 24 hours urine potassium 69 mmol/L, urine sodium 384 mmol/L, and urine chlorine 350 mmol/L. Bone mineral density examination showed osteoporosis. Adefovir dipivoxil-related FS was diagnosed and calcitriol (0.25  g/d) was added. Three months later, weakness of bilateral lower extremities was improved markedly. Tenofovir disoproxil was discontinued and changed to entecavir (0.5 mg/d). Six months after discontinuation of adefovir dipivoxil, weakness of bilateral lower extremities subsided, right hypochondrium pain alleviated, and moderate physical activity could be tolerated, serum phosphorus, calcium, and uric acid levels returned to normal, and urine electrolyte output was obviously reduced.
  • Yang Xue, Xue Yu, Zhu Xiaoxia, Zou Hejian
  • Du Qingqing, Wang Na, Liu Rui, Zhao Chunjing, Qian Yan, Zhao Li
    A 66-year-old male patient received aspirin enteric-coated tablets (100 mg once daily) and ticagrelor tablets (90 mg twice daily) after percutaneous coronary intervention (PCI). After 2 weeks of treatments, a small amount of melena appeared and gradually worsened with dizziness and weakness. The symptoms were not markedly improved after treatments with acid suppression, gastric protection, hemostasis, and repeated blood transfusions. Aspirin enteric-coated tablets and ticagrelor were stopped, fasting, infusion of suspended red blood cells, intravenous esomeprazole (80 mg once every 8 hours) via an infusion pump, oral almagate suspension (1.5 g thrice daily), and nutritional support treatments were given. On day 4, the symptoms were not improved and intravenous pumping of octreotide 0.6 g once every 12 hours was added; on day 8, the patient developed tar-like stools approximately 1000 g, blood pressure 92/62 mmHg, and hemoglobin (Hb) 43 g/L. Gastroscopy showed superficial gastritis. Colonoscopy failed because rectal mucosa was covered. Lower gastrointestinal bleeding was considered continuously and Yunnanbaiyao (云南白药) and thrombin were applied. On day 13 after aspirin enteric-coated tablets and ticagrelor withdrawal, the patient′s Hb dropped to 37 g/L, BP 85/59 mmHg, and developed severe anemia. On day 25, laparotomy was performed. During the operation, it was found that the small intestine was significantly dilated, the cavity was black and there were a large number of diffuse petechiae on the mucosa which were at 100 to 200 cm from the Treitz ligament. The bleeding intestinal segment was removed and acid suppression, hemostasis, and nutritional fluid support treatments were given. After that, melena did not recur and anemia was gradually improved. On the 16th day after the partial small intestine resection, the abdominal incision healed well and laboratory tests showed Hb 88g/L.
  • Li Sha, Li Ning, Yang Lijie, Ma Lan, Liu Fang, Wang Fang
    ObjectiveTo explore the risk points of medication errors in the management process of intravenous theophyllines by failure mode and effect analysis (FMEA) and improve the management measures to enhance the medication safety. MethodsThe potential safety risks in each link during intravenous theophyllines circulation in First Affiliated Hospital of PLA General Hospital and the First Affiliated Hospital of Harbin Medical University were analyzed using FMEA method and the risk priority number (RPN) was calculated. The risk points, whose RPN scores were >216, were taken as the key ones during the management of intravenous theophyllines. Management and technical strategies were drawn up for the key risk points and preventive effects before and after the improvement measures were compared.ResultsAfter comprehensive evaluation, the key risk points such as missing information of drug instructions, wrong dosage, inappropriate assessment for patients, omission of prescription checking, absence of blood concentration monitoring, and imperfection of doctor′s advice to patient and etc. were sorted out, and management and technical strategies were drawn up. The RPN scores of above risk points decreased from (269±41) to (53±27) before and after the implementation of preventive strategies and the difference was statistically significant (t=9.454, P<0.001).ConclusionThe importance of failure modes in safety management of drugs is quantified by FMEA method, priority sequence of improvement for high-alert medication management is pointed out, and medication safety is improved.
  • 病例报告
    Zhang Yumeia;Wang Hujunb;Liu Hongtaoa;Wang Yapinga;Zhu Jinga
    . 2010, 12(6): 441-2.
    An 80yearold woman with uremia underwent hemodialysis and received an initial dose of standard heparin 24 mg and then a maintenance dose of 5.2 mg/h lasting 3.5 4 hours. Fifteen months later, the patient developed oral ulcer. The symptoms worsened gradually and then ulcer pain and dysphagia appeared. Meanwhile she presented with a 5 mm×8 mm ulcer on the right side of her tongue and a 7 mm×9 mm ulcer in her right oral cavity mucous membranes. Standard heparins was withdrawn and switched to low molecular weight heparin 3 000 IU. Her symptoms relieved. Three days later, she underwent hemodialysis and received standard heparin again and her ulcer then aggravated. Subsequently, standard heparin was changed to low molecular weight heparin again and her ulcer markedly improved but did not heal. And the anticoagulant heparin used for sealing tube was replaced with urokinase. Her ulcer healed completely and did not recur.
  • 病例报告
    Hou Xiaoping;Miao Jingli
    . 2011, 13(1): 56-3.
    A 91yearold man with coronary artery disease received venlafaxine 150 mg/day for treatment of anxiety/depression for about one year. Because of his aggravated mental symptoms, the withdrawal of venlafaxine and the administration of other drugs were planned. Subsequently, venlafaxine was decreased to 75 mg/day, and then discontinued 1 day. The next day morning, the patient suddenly developed unconsciousness and, 10 minutes later, he regained consciousness. His blood pressure was 50/30 mm Hg. He was treated with dopamine. The second day, acute myocardial infarction was confirmed by ECG, and venlafaxine withdrawal syndrome was diagnosed. The patient was given aspirin, clopidogrel, nitroglycerin, and quetiapine. Later, the patient markedly improved and, after 20 days of hospitalization, he was discharged.
  • 安全信息
    . 2011, 13(1): 26-1.
  • 病例报告
    Jing Hua
    . 2010, 12(4): 279-2.
    A 17monthold male child with type 1 diabetes was hospitalised for undergoing autologous hematopoietic stem cell transplantation. After admission, he was given SC filgrastin 5.0 μg/kg for hematopoietic stem cell mobilization followed by cyclosporine 25 mg twice daily, on day 12, his liver function was normal. Cyclosporine was stopped and changed to an IV infusion of antithymocyte globulin 8 mg on first day and 12 mg on second day. Subsequently, biochemical tests revealed the following values: ALT 1 041 U/L, AST 209.3 U/L, ALP 296.4 U/L, LDH 695.1 U/L, TBil 19.3 μmol/L, DBil 11.7 μmol/L. Antithymocyte globulin was withdrawn immediately and liverprotective treatments were given.His liver function improved gradually. Twenty days later,he received hematopoietic stem cell reinfusion and was discharged without discomfort. His liver function was normal at half a year follow-up.
  • 病例报告
    Li Pengfei;Yang Deyong;Zheng Xueyi
    . 2011, 13(4): 252-2.

    A 20-year-old man developed palpitations, nausea, vomiting, and dizziness 30 minutes after the patient himself took astemizole 3 mg for pruritus with rash in his entire body. His symptoms relieved after symptomatic treatment. A review of his medical history revealed that the patient had taken 2 doses of astemizole at the same dosage, and his dizziness and palpitation had occurred after taking each dose of astemizole and than the symptoms had spontaneously disappeared.

  • 病例报告
    Yu Dongwei;Gu Qinhua
    . 2011, 13(2): 114-2.
    A 69yearold woman with type 2 diabetes suddenly developed slurred speech and mouth distortion and then was hospitalized. Before admission, the patient received gliclazide 80 mg twice daily and aspirin 0.1 g once daily. A blood glucose test showed a glucose level of 1.7 mmol/L. An IV injection of 50% glucose 100 ml was administered. One hour later, her blood glucose level increased to 20 mmol/L, and her symptoms relieved. Gliclazide was discontinued and replaced with 1 tablet of sustainedrelease glipizide 5 mg once daily. The next day, her fasting blood glucose level was 1.7 mmol/L and her postprandial blood glucose level was 2.7 mmol/L.She also had palpitation, dizziness, and so on. Her symptoms improved after receiving an IV infusion of 10% glucose 250 ml. On days 35 of admission, the hypoglycemic agent was withdrawn, her blood glucose levels were then maintained between 82 mmol/L(fasting) and 10.1 mmol/L(postprandial).On day 6, 1 tablet of sustainedrelease glipizide 5 mg once daily was readministered. Her blood glucose level was maintained within 5.56.5 mmol/L. Two days later, she was discharged and continued taking sustainedrelease glipizide tablets. On day 12 after discharge, the patient suddenly redeveloped unconsciousness and no response to verbal stimuli, and then she was readmitted. A blood glucose test showed a glucose level of 1.6 mmol/L. On day 3 of admission, she started received metformin therapy,and her 2hour postprandial blood glucose level was maintained at approximately 8.7 mmol/L. On day 9, she was discharged.
  • LIU Jun;XU Wen-ke
    A 63-year-old male with asthma received digoxin 0.125 mg once daily for tiredness and short of breath during sleep due to chronic cardiac insufficiency. On day 5 of taking digoxin, his symptoms improved. The dose of digoxin was increased to 0.5 mg twice daily by himself for 7 days and the patient′s asthma symptoms was exacerbated. He could not lie down for sleep at night and had fatigue, poor appetite, disorder of the stomach, nausea, and vomiting. Electroncardiography showed Ⅲ degree atrioventricular block, frequent premature ventricular contractions and bigeminy. The patient′s ventricular rate was 57 beats per minute. Laboratory tests revealed the following levels: serum potassium 2.9 mmol/L, digoxin plasma concentration>5.0 μg/L. Digoxin was withdrawn immediately. Potassium supplement and other sympto-matic treatment were given. Five days later, his symptom was improved and the electrocardiogram and serum potassium recovered to normal. Digoxin 0.125 mg once daily was given again. Five days later,laboratory tests revealed the following levels: serum potassium 4.3 mmol/L, digoxin plasma concentration 1.78 μg/L. The patient did not present the symptoms of nausea and vomiting again.
  • 病例报告
    . 1999, 1(3): 184-184.
  • 不良事件
    . 2005, 7(1): 14-14.
  • 药物评介
    . 2000, 2(4): 271-272.
  • 个案分析
    . 2005, 7(1): 64-65.
  • ADR护理
    . 2002, 4(5): 321-322.
  • 不良事件
    . 2002, 4(3): 199-199.
  • 病例报告
    . 2003, 5(3): 190-191.
  • 中药不良反应
    . 2006, 8(6): 460-460.
  • 药物滥用
    . 2006, 8(6): 440-441.
  • 不良事件
    . 2003, 5(2): 123-123.
  • 病例报告
    . 2004, 6(4): 269-269.
  • 病例报告
    Liu Ensheng;Lv Xin
    . 2008, 10(6): 0-0.

    Two patients receiving succinylated gelatin injection during surgery developed anaphylactic shock.Patient 1, a 16-year-old woman received an IV infusion of succinylated gelatin during undergoing malignant schwannoma resection. After infusion of 20-30 ml, her BP suddenly fell to 26/20 mmHg with a HR of 150 beats/min, and her generalized skin had an ‘orange peel’ appearance. The surgery was stopped immediately. Her condition improved after antianaphylactic and anti-shock treatment. Three days later, she underwent surgery again. The anesthesia remained the same and no adverse reactions occurred.Patient 2, a 46-year-old woman underwent an exploratory laparotomy for recurrence of postoperative ovarian cancer. She received an IV infusion of succinylated gelatin during surgery. After infusion of about 100 ml, her BP abruptly fell to 40/20 mmHg, and her chemosis occurred. The medication was withdrawn at once and her condition improved after antianaphylactic and antishock treatment. Her surgery was continued.

  • 不良事件
    . 2004, 6(2): 128-128.
  • 不良事件
    . 2003, 5(1): 41-41.
  • 不良事件
    . 2003, 5(6): 429-429.
  • 抗菌药应用
    . 2005, 7(1): 41-47.
  • 病例报告
    . 2003, 5(5): 335-336.
  • 不良事件
    . 2002, 4(4): 270-270.
  • ADE简报
    . 2001, 3(4): 261-261.
  • 病例报告
    YANG De-yong;LI Peng-fei;ZHENG Xue-yi
    . 2012, 14(2): 122-2.
    A 72-year-old female patient received carbamazepine 0.1 g twice daily for postherpetic neuralgia. One day later, she experienced retention of urine. The drug was discontinued and, after catheterization therapy, she could urinate normally. Four days after carbamazepine discontinuation, the patient received oxcarbazepine 0.3 g twice daily. The next day, she redeveloped urinary retention and dysuria. Then oxcarbazepine was stopped. Retention catheterization and anti-infective therapy were given. Seven days later, the patient urinated normally.
  • 病例报告
    Yan Nuo
    . 2010, 12(6): 442-2.
    A 10yearold boy received topical application of 1.5% chitosan 5 mL on the surfaces of the intestinal tract and peritoneum for preventing postoperative intestinal adhesion during undergoing appendectomy. After surgery, the boy developed urticaria on his chest and abdomen and, 5 minutes later, his urticaria progressed to involving his entire body, followed by facial edema, shortness of breath, a BP of 50/30 mm Hg, and a pulse rate of 165 beats/min. Anaphylactic shock was considered to be related to chitosan. Adrenaline, methylprednisolone and calcium gluconate were given immediately and, five days later, the boy recovered and was discharged.
  • Song Jie, Qiu Feng, Meng Long, Yang Jiadan, Xiao Mingzhao
  • . 2017, 19(6): 479.
  • Zhang Xinru, Zhu Dasheng, Chen Yadan, Fu Xiujuan
    . 2016, 18(6): 434.
    ObjectiveTo re-evaluate the post-marketing safety of Dazhuhongjingtian injection and to explore the safety re-evaluation method of traditional Chinese medicine injection.MethodsTo observe and analyze inpatients admitted to the department of cardiovascular medicine in the second hospital of Jilin University from November 2013 to February 2016 by using the non-interventional centralized monitoring method with participation of pharmacists and nurses. All the patients enrolled were treated with Dazhuhongjingtian injection. We further analyzed the clinical application of this injection as well as the adverse event.ResultsA total of 3 000 patients (1 560 male and 1 440 female) were enrolled in this study. Of them, the average age was (61±11) years (17-97 years), 29 patients had allergic history, 388 patients (12.93%) were medication beyond the indications of Dazhuhongjingtian injection due to their primary diagnosis of non-coronary heart disease. The solvent dosage and/or types of 2 975 patients (99.17%) did not conform to the instructions. The treatment duration of 917 patients (30.57%) was over 10 days. Of 2 999 patients receiving drug combination with 1-30 kinds, the average kinds was (9±4). Adverse events occurred in 19 patients (0.63%). Of them, 10 male and 9 female with the average age of (60±11) years (35-82 years), 4 patients had the allergic history. The incidence of adverse event with allergic history was higher than that without allergic history [13.79% (4/29) vs. 0.50% (15/2 971), P<0.05]. There were no significant differences in the adverse event incidence between patients among different ages, with or without ultra-indication and the combination drugs (all P>0.05). All adverse events occurred within one week, 8 cases (42.11%) happened in the first day of the medicine. The symptoms were generally mild, mainly for skin rashes, itching, dizziness and palpitation. These symptoms can be improved or disappear after medication withdrawal and symptomatic treatment.ConclusionsThe Dazhuhongjingtian injection is comparatively safe. It was proved to be a good mode for post-marketing safety re-evaluation of traditional Chinese medicine injection by non-interventional prospective monitoring with pharmacists and nurses participating in. Off-label drug use of Dazhuhongjingtian injection existed in clinical practice. We sincerely recommend the manufacturer to carry out research according to its clinical application and to provide the clinic convenience.
  • Li Qiulian, Zhu Qingdong, He Wei, Zhao Rui, Lu Ning, Liang Yunguang,
    Adverse Drug Reactions Journal. 2020, 22(10): 559-562. https://doi.org/10.3760/cma.j.cn114015-20200223-00154
    Objective To explore the occurrence of adverse reactions of lopinavir/ritonavir (LPV/r) in the treatment of coronavirus disease 2019 (COVID-19). Methods The medical records of patients with COVID-19 who received LPV/r treatment in the Fourth People′s Hospital of Nanning from January 24th to February 6th, 2020 were collected and the occurrence of adverse events during the treatment was retrospectively analyzed. According to the 5 principles of adverse drug reaction correlation evaluation proposed in the Handbook of Adverse Drug Reaction Reporting and Monitoring in China, adverse events that were certainly related, probably related, and possibly related to LPV/r were defined as LPV/r-related adverse reactions. The incidence of adverse reactions was calculated and the main clinical manifestations and severity of adverse reactions [grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), and grade 5 (death);grade 3-5 was defined as severe adverse reaction] were analyzed. Results A total of 28 patients were enrolled in the analysis, including 13 males and 15 females, aged from 18 to 70 years with an average age of 44 years. The courses of treatment with LPV/r of patients ranged from 2 to 12 days, with a median course of 6 days. Of the 28 patients, 18 developed LPV/r related adverse reactions, with an incidence of 64.3%. The LPV/r-related adverse reactions in 18 patients included gastrointestinal reactions in 14 patients (grade 1 in 13 patients and grade 2 in 1 patient), bradycardia in 2 patients (grade 2 in both patients), and acute hemolysis in 1 patient (grade 3), and liver injury in 1 patient (grade 3), and no grade 4 or 5 adverse reactions occurred. The incidence of severe adverse reactions was 7.1%. Thirteen patients with grade 1 adverse reactions did not affect the treatment, and the symptoms were relieved after 2-7 days of continuous medication. LPV/r was discontinued in 5 patients with grade 2 or 3 adverse reactions, 4 of whom received symptomatic treatment, and the symptoms disappeared 2-10 days later. Conclusions The incidence of adverse reactions in COVID-19 patients treated with LPV/r in our hospital was 64.3%. LPV/r mainly leads to mild gastrointestinal reactions and can also lead to bradycardia, acute hemolysis, and liver injury. Blood routine, liver function, and electrocardiogram need to be monitored during the treatment.
  • 病例报告
    Qian Jun;Ning Feng;Wang Jingwen
    . 2010, 12(6): 436-1.
    A 60yearold woman with malignant lymphoma received combined chemotherapy with cyclophosphamide, doxorubicin, vincristine, and prednison. Her fibrinogen levels were 2.613.73 g/L in previous six cycles of chemotherapy. Before the seventh chemotherapy cycle, the patient was given an IV infusion of omeprazole 40 mg once daily for gastrointestinal hemorrhage. On day 11 of drug use, she had a fibrinogen level of 0.42 g/L and a positive plasma protamine paracoagulation. Omeprazole was stopped and fresh frozen plasma 400 mL/d was given for two days. On day 6 after discontinuation, the fibrinogen level returned to 2.61 g/L and plasma protamine paracoagulation test was negative. Subsequently, her fibrinogen levels ranged from 1.54 to 2.70 g/L.
  • 安全信息
    . 2010, 12(4): 299-2.
  • 安全信息
    . 2011, 13(4): 269-1.
  • 中药不良反应
    ZHAO Xiao-wei;XU Can-li
    . 2012, 14(1): 60-2.

    A 57-year-old woman with inactive HBsAg carrier had normal hepatic function and hepatitis B virus (HBV) DNA levels < 500 copies/ml during the past 10 years of follow-up. She received 3 capsules of Xianlinggubao (仙灵骨葆) 0.5 g twice daily due to fracture. Two months later, omeprazole 20 mg once daily and 2 capsules of Dengzhanshengmai (灯盏生脉) 0.18 g twice daily were added to her treatment regimen for stomach discomfort. After three months of concomitant use of these medications, her liver function tests were abnormal as follows: alanine aminotransferase (ALT) 389 U/L and aspartate aminotransferase (AST) 229 U/L. She was diagnosed with drug-induced hepatitis and hepatitis B virus reactivation. The above-mentioned drugs were stopped and she was given diammonium glycyrrhizinate capsules and Shenqigankang (参芪肝康) capsules for liver protection treatment. A week later, repeat liver function tests showed the following levels: ALT 236 U/L,AST 120 U/L,HBV DNA 1.25×106 copies/ml. Two weeks later, the laboratory indices revealed the following levels: ALT 73 U/L AST 54 U/L,HBV DNA 2.36×105 copies /ml.

  • . 2013, 15(3): 147-1.
  • 病例报告
    . 2005, 7(4): 295-295.
  • 病例报告
    . 2002, 4(6): 406-406.
  • 不良事件
    . 2002, 4(6): 412-412.
  • 个案分析
    . 2003, 5(5): 339-340.
  • 不良事件
    . 2005, 7(3): 226-226.
  • 不良事件
    . 2005, 7(6): 464-464.
  • 监测交流
    . 2005, 7(5): 377-379.
  • 实验论著
    Yuan Weili;Wang Xukai;Liu Dongjuan
    . 2009, 11(3): 174-5.
    Objective: To investigate the effect of different pingyangmycin concentrations on normal rabbit lip tissue. Methods:Thirtyone rabbits were randomly divided into three group: the 8 mg/5 ml dose group (15 rabbits), the 8 mg/3 ml dose group (15 rabbits), and the control group (one rabbit). The rabbits in both dose groups were redivided into 5 subgroups (3 rabbits in each subgroup), respectively. The rabbit right upper lip in the each subgroup was injected with 0.5 ml of pingyangmycin 8 mg/5 ml and pingyangmycin 8 mg/3 ml,respectively. The rabbit right upper lip in the control group was injected with same volume of normal saline. The changes in the rabbit lip were observed every day. The repeated injection was performed on week 2 after the first injection. Three rabbits in each subgroup of both dose groups were sacrificed on days 21,28,35,60, and 90 after the first injection and the rabbit in the control group was sacrificed on day 90 after the first injection. Adverse reactions at the local injection site were observed, and the lip thickness was measured at the different time points after injection. The pathological changes in the rabbit lip tissue were observed under light microscope and transmission electron microscope. Results: In the 8 mg/5 ml dose group, asymmetric changes in the rabbit bilateral upper lip were not found and the thickness of injection site of the rabbit lip was respectively(4.18±0.04)mm,(4.16±0.06)mm,(4.16±0.03)mm,(4.14±0.05)mm, and(4.12±0.02)mm on days 21, 28, 35, 60, and 90 after the first injection. In 8 mg/3 ml dose group, swelling of injection site of the rabbit upper lip, mild atrophy of upper lip, and sclerosis of local mucous membrane occurred, and the thickness of injection site of the rabbit lip was respectively (3.48±0.01)mm,(3.36±0.02)mm,(2.64±0.11)mm,(1.56±0.14)mm, and(1.38±0.18)mm at different time points after the first injection. The differences in the thickness of injection site of the rabbit lip at different time points between the 8 mg/5 ml dose group and the 8 mg/3 ml dose group were statistically significant (all P< 0.01). On day 28 after injection, light microscopic examination of the rabbit lip tissue from injection site in the 8 mg/3 ml dose group revealed vacuolar degeneration of vascular endotheliocyte, intravascular thrombosis and obstruction, hyperplasia and degeneration of collagenous fibers, and a replacement of a part of muscle fibers by collagenous fibers. On day 90 after injection, electron microscopic examination revealed normal mitochondria, clear mitochondrial cristae, regular arrangement of muscle fibers in the 8 mg/5 ml dose group, as with the control group; and dissolution of a part of muscle fibers, swelling of myofilaments, rupture of mitochondrial outer membrane, dissolution of mitochondrial cristae, and vacuolar degeneration of some mitochondria in the 8 mg/3 ml dose group.Conclusion: Local injection of pingyangmycin 8 mg/5 ml in the normal rabbit lip tissue is safer than that of pingyangmycin 8 mg/3 ml.
  • 病例报告
    . 2005, 7(4): 292-292.
  • ADR监测
    . 2001, 3(2): 103-104.
  • ADE简报
    . 2000, 2(4): 265-265.
  • 病例报告
    . 2006, 8(6): 422-422.
  • Xiong Yaqun, Zhou Shihai, Xiao Xinghua, Luo Ping
    Adverse Drug Reactions Journal. 2022, 24(5): 266-268. https://doi.org/10.3760/cma.j.cn114015-20210830-00942
    An 11-year-old boy received tofacitinib (oral 7.5-mg once daily) on the basis of methotrexate therapy (oral 10-mg once a week) due to poor control of juvenile idiopathic arthritis, and the symptoms were relieved. The boy′s liver function was normal before using tofacitinib. After more than 2 months of combined use of the 2 drugs, laboratory tests showed alanine aminotransferase (ALT) 178-U/L and aspartate aminotransferase (AST) 78-U/L. No intervention was given because there were no clinical symptoms. His liver enzyme elevated significantly (ALT 586-U/L, AST 170-U/L) after continued medication for 1 month. After excluding viral hepatitis, autoimmune hepatitis, and other liver diseases, drug-induced liver injury was considered. Methotrexate was discontinued, tocilizumab was added, and liver protection therapy with reduced glutathione and magnesium isoglycyrrhizinate was given. Eleven days of methotrexate withdrawal, the laboratory tests showed ALT 512-U/L and AST 194-U/L. Then tofacitinib was discontinued and hepatic enzyme decreased significantly (ALT 150-U/L, AST 41-U/L) 3 days later. The liver injury was considered to be related to tofacitinib. The liver protection therapy was continued for 1 week, and the liver function examination showed ALT 41-U/L and AST 35-U/L.
  • Wang Xinglong, Hu Qingyuan, Bai Jie, Song Zhihui
    Adverse Drug Reactions Journal. 2024, 26(4): 223-228. https://doi.org/10.3760/cma.j.cn114015-20231218-00910
    Objective To investigate the risk of adverse event (AE) associated with inclisiran and to provide reference for the safe use in clinical practice. Methods The AE reports in the US FDA Adverse Event Reporting System (FAERS) database from the 4th quarter of 2004 to the 2nd quarter of 2023 with inclisiran as the primary suspect drug were collected. AE was standardized and classified using the preferred terminology (PT) and the system organ class (SOC) of the Medical Dictionary for Regulatory Activities 26.0. AE risk signal mining was performed using the report odds ratio (ROR) method and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard method. PT that was considered as an AE risk signal in both methods were defined as AE risk signals [ROR method: ≥3 reports  and the lower limit of the 95% confidence interval (CI) of the ROR>1; MHRA comprehensive standard method: ≥3 reports、PRR ≥2 and χ2≥4]. A descriptive statistical analysis was performed. Results A total of 1 888 AE reports were collected with inclisiran as the primary suspect drug, involving 1-888 patients and 835 PTs. The AE was predominantly reported in the United States (88.7%, 1 675/1 888), and predominantly by the consumer (62.1%, 1 171/1 886); there were a total of 484 reports (25.6%) about serious AE. Excluding non-drug and indication-related PTs, 85 PTs (involving 15 SOCs) met the criteria in both the ROR method and the MHRA comprehensive standard method, and defined as AE risk signals. The top 5 PTs ranked by the number of reports were arthralgia (248 cases), injection site pain (237 cases), limb pain (170 cases), myalgia (158 cases), and diarrhea (132 cases); the top 5 PTs ranked by the signal intensity included bladder discomfort (ROR=28.87, PRR=28.85), injection site discomfort (ROR=24.48, PRR=24.40), sinus pain (ROR=23.20, PRR=23.19), injection site vesicles (ROR=17.63, PRR=17.61), and injection site rash (ROR=12.51, PRR=12.45). Among the top 20 PTs ranked according to the number of reports and signal intensity respectively, 8 and 13 PTs were not documented in domestic and international specifications, of which myalgia and hypoacusis had more reports and stronger signal intensity. Conclusion The main AE  of inclisiran in the US FAERS database were injection site reactions, followed by musculoskeletal-related AEs (arthralgia, myalgia, and myospasm, etc.) and infection-related AEs (such as urinary tract infections and bronchitis), which require clinical attention.
  • Guo Dongjie, Li Pengmei
    Adverse Drug Reactions Journal. 2024, 26(2): 123-125. https://doi.org/10.3760/cma.j.cn114015-20230331-00243
    A 66-year-old male patient who underwent lung transplantation took a combination therapy with tacrolimus, mycophenolate sodium, and prednisone for a long time to resist rejection.Due to the occurrence of novel coronavirus and pulmonary fungal infection,the patient was given antiviral therapy with nirmatrelvir/ritonavir (Pavlovid), followed by antifungal therapy with voriconazole 2 days later.Before voriconazole treatment, the patient′s alanine aminotransferase was 34 U/L, and aspartate aminotransferase was 28-U/L. On the 4th day of the combination of voriconazole and Paxlovid, the patient′s blood trough concentration of voriconazole was 16.06-mg/L, alanine aminotransferase was 176-U/L, and aspartate amino- transferase was 166-U/L. Voriconazole was discontinued immediately and 2 days later,Paxlovid was discon- tinued. Five days after discontinuation of voriconazole, the patient′s liver function returned to normal; 9 days later, blood trough concentration of voriconazole was 5.84-mg/L. It was considered that the patient′s liver injury was caused by the combination of voriconazole and Paxlovid.
  • Zhang Hongmei, Deng Jiayu, Wang Xiangfeng, Song Yanqing
    Adverse Drug Reactions Journal. 2024, 26(5): 285-290. https://doi.org/10.3760/cma.j.cn114015-20231211-00878
    Objective To explore the safety of simnotrelvir/ritonavir in the treatment of coronavirus disease 2019 (COVID-19). Methods The medical records of adult patients with COVID-19 who were hospitalized in Lequn Branch, Hospital of the First Hospital of Jilin University from June 9 to September 30, 2023 and treated with simnotrelvir/ritonavir were collected. According to whether adverse drug reactions (ADR) related to simnotrelvir/ritonavir occurred, the patients were divided into ADR group and non-ADR group. The clinical data, occurrence time of ADR, clinical manifestations, severity, treatment and outcome of patients were analyzed retrospectively. Results A total of 189 patients were enrolled in this study, inclu- ding 92 males (48.7%) and 97 females (51.3%), with a median age of 69 (60.5, 74.0) years. The usage and dosage of simnotrelvir/ritonavir were in accordance with the instructions (0.75 g of simnotrelvir and 0.1 g of ritonavir orally, once every 12-hours for 5 days). ADR related to simnotrelvir/ritonavir occurred in 18 of 189 patients (9.5%). There were no significant differences (all P>0.05) in gender, age, smoking status, COVID-19 classification and the proportion of patients with basic diseases such as hypertension, diabetes, cardiovascular disease, cerebrovascular disease, lung disease, and tumor after surgery between the ADR group (18 patients) and non-ADR group (171 patients). The difference in the propation of patients with liver injury and kidney injury between the 2 groups were statistically significant (both P<0.05). A total of 23 cases of ADR occurred in the ADR group. The occurrence time of ADR was 1 to 8 days after taking simnotrelvir/ritonavir. The clinical manifestations of ADR included digestive system symptoms, elevated transaminases, elevated serum creatinine, elevated serum uric acid, decreased platelet count, decreased white blood cell and neutrophil counts, dizziness, headache, etc. Five patients had 2 kinds of symptoms at the same time. The severity of ADR was grade 1 in 12 patients and grade 2 in 6 patients, and no ≥ grade 3 severe ADR occurred. Except one patient who stopped taking medication due to thrombocytopenia, all other patients completed 5-day treatment. The ADR disappeared after discontinuation of simnotrelvir/ritonavir and 1 to 5 days of symptomatic treatments. Conclusions Simnotrelvir/ritonavir has a good safety in the treatment for COVID-19. The main ADRs are diarrhea and elevated transaminases, with the severity of grade 1-2 and the ADRs disappear after drug withdrawal. The patients with liver and kidney injury should be more alert to the occurrence of ADR when applying simnotrelvir/ritonavir.
  • Peng Wenxing, Chen Guoquan, Ding Zheng
    Adverse Drug Reactions Journal. 2025, 27(1): 11-16. https://doi.org/10.3760/cma.j.cn114015-20240430-00296
    Objective To mine the risk signal of acute kidney injury (AKI) induced by different oral anticoagulant drugs (OACs) in various populations and provide a reference for clinical use of OACs.  Methods Reports of AKI induced by OACs and non-OACs in the US Food and Drug Administration Adverse Event Reporting System database from the 1st quarter of 2004 to the 3rd quarter of 2023 were collected. The relationship between the drugs mentioned above and the AKI in patients were analyzed by methods of reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN). When the number of reports of the target adverse event (AE) for the target drug was ≥3, and the lower limit of the 95% confidence interval (CI) of ROR was >1 or the lower limit of the 95%CI of the information component (IC025) was >0, it indicated a statistically significant association between the target drug and the target AE. Results A total of 12 402 AKI reports related to OACs were collected, including 1 313 for warfarin, 3 086 for dabigatran, 4 730 for rivaroxaban, 2 918 for apixaban, and 365 for edoxaban; 454 378 AKI reports were related to non-OACs. The overall analysis of OACs showed an ROR (lower limit of 95%CI) of 1.791 (1.759) and an IC (IC025) of 0.813 (0.787) for AKI caused by OACs. Analysis of individual OACs showed that warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban all posed risks for AKI, with ROR (lower limit of 95%CI) of 1.220(1.156), 2.386(2.302), 2.044(1.986), 1.375(1.326), 3.003(2.706), respectively, and IC (IC025) of 0.284(0.204), 1.231(1.178), 1.010(0.968), 0.452(0.399), 1.560(1.407), respectively. Edoxaban had the highest ROR and IC values, while warfarin had the lowest. Subgroup analysis showed that in the <18 years subgroup, neither warfarin nor rivaroxaban showed a risk of AKI; the ROR method did not show dabigatran to have a risk of AKI, but the BCPNN method did. In the 18-45 years subgroup, both methods showed that apixaban did not have a risk of AKI, while all other OACs did. In the 45-64 years subgroup, all OACs showed a risk of AKI. In the ≥65 years subgroup, warfarin and apixaban posed risks for AKI. Gender subgroup analysis showed that both methods indicated a risk of AKI with warfarin in males; all OACs showed a risk of AKI in females. Conclusions OAC has a statistically significant risk of AKI, among which edoxaban has the highest risk intensity and warfarin has the lowest. Different OACs have different risks of AKI in patients with different ages.
  • Mei Kangkang, Zhan Didi, Luo Zhihong, Cai Heping
    Adverse Drug Reactions Journal. 2021, 23(9): 500-502. https://doi.org/10.3760/cma.j.cn114015-20201222-01267
    A 1-year and 4 month-old boy with epilepsy received sodium valproate oral solution 2.5-ml twice daily, Shengxue Tiaoyuan decoction(升血调元汤) 6-ml twice daily and five vitamins and  calcium gluconate oral solution 3-ml twice daily. On day 13 of treatments, the boy developed red maculopapular rashes and blisters all over the body, some of which fused into pieces; his bilateral conjunctiva slightly congested with secretions, mouth and lip mucosa congested and eroded, and a few maculopapular rashes appeared on the external genitalia. At the same time, the boy′s body temperature rose up to 40.0-℃. Stevens-Johnson syndrome was diagnosed, which was considered to be related to sodium valproate oral solution. The drug was stopped immediately and treatments such as blood perfusion, infusion of plasma and red blood cells, anti-infection and hormone therapy, and eye and skin care were given. On the 17th day of treatments after drug withdrawal, the rashes on the whole body subsided, ulceration scabbed, erosion of oral and lip mucosa cured, and conjunctival congestion disappeared.
  • 不良事件
    . 2003, 5(2): 121-121.
  • 专题讲座
    . 2004, 6(2): 106-108.
  • 病例报告
    . 2003, 5(4): 285-285.
  • WHO信息
    . 2003, 5(4): 277-277.
  • 不良事件
    . 2004, 6(4): 282-282.
  • 个案分析
    . 2004, 6(4): 261-262.
  • ADR术语
    . 2002, 4(3): 211-213.
  • 病例报告
    . 2002, 4(4): 220-220.
  • 病例报告
    . 2006, 8(4): 294-295.
  • 药物安全动态
    . 2006, 8(3): 232-233.
  • 不良事件
    . 2002, 4(5): 323-323.
  • 病例报告
    . 2002, 4(5): 336-337.
  • 病例报告
    . 2002, 4(5): 333-333.
  • 网络医药
    . 2002, 4(3): 186-190.
  • ADE简报
    . 2000, 2(2): 130-130.
  • 监测简报
    . 2003, 5(5): 341-342.
  • WHO信息
    . 2002, 4(6): 417-417.
  • ADE简报
    . 2001, 3(4): 260-260.
  • 误用滥用
    LI Ying;CHEN Yue-xiang
    . 2012, 14(3): 168-2.
    A 60-year-old male patient self-medicated with oral sorafenib 0.2 g twice daily after renal cancer surgery. After two months of treatment, he presented with generalized weakness, scleral jaundice and dark urine. Laboratory tests revealed the following levels: total bilirubin (TBil) 146 μmol/L, direct bilirubin (DBil) 94 μmol/L, alanine aminotransferase (ALT) 959 U/L, aspartate aminotransferase (AST) 1150 U/L and gamma-glutamyltransferase (γ-GT) 507 U/L. Sorafenib was stopped and he was given cytidine disodium triphosphate, reduced glutathione and ademetionine. Twenty-four days later, repeat liver function tests revealed the following levels: TBil 19 μmol/L, DBil 10 μmol/L, ALT 54 U/L, AST 40 U/L, γ-GT 22 U/L.
  • 学术动态
    . 2011, 13(5): 334-2.
  • 病例报告
    Guo Yuzhi;Miao Shuxia;Wang Fengzhi;Tian Yin
    . 2010, 12(4): 275-2.
    A 51yearold male patient received IM compound aminophenazone and barbital injection 2 mL for fever and chill. One hour later, an IV infusion of phosphonomycin 4 g in 5% glucose 250 mL was given due to poor efficacy. During the infusion, the patient developed chest distress, shortness of breath, and the symptom of chill was aggravated. Subsequently, phosphonomycin was withdrawn and promethazine, adrernalin, dexamethasone, and dextran were given. However, the symptoms did not improve and the patient experienced dyspnea. The next day, he presented with marked cyanosis in the face and whole body skin with massive ecchymosis, palpebral edema, conjunctival congestion, and cool clammy extremities. Moist rales were heard in both lungs. Laboratory examination showed a PLT level of 45×109/L, a prothrombin time of 37.3 s, an activated partial thromboplastin time of 78.1 s,and a D-dimer level of 1 600-3 200 μg/L. Finally, he died despite resucitation efforts.
  • ADR咨询
    . 2006, 8(3): 234-234.
  • Li Jun, Xie Han, Deng Ang, Ji Lianmei
    Adverse Drug Reactions Journal. 2018, 20(6): 401-404.
  • Wang Wenxi, Pan Guohong, Wu Sanlan
    . 2017, 19(4): 267.
    ObjectiveTo understand the clinical characteristics, treatment and prognosis of tenofovir (TDF)-induced Fanconi syndrome (FS).MethodsThe related databases were electronically searched for the cases of FS induced by TDF before November 2016. The related data of the patients were recorded and summarized. The results of detection of related laboratory parameters before and after the treatment for FS induced by TDF were compared. The clinical characteristics, and prognosis of FS induced by TDF were analyzed. The correlation of TDF and FS was analyzed by using Naranjo probability scale.ResultsA total of 59 cases were collected comprising 42 males (71.2%) and 17 females (28.8%) with age from 17 to 82 years, and the average age (46±13) years. The number of cases with human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) infection, and HIV with HBV infection were 48 (81.4%), 8 (13.6%), and 3 (5.1%), respectively. Eight patients (13.6%) were treated with TDF only, 51 patients (86.4%) were treated with TDF combined with other antiviral drugs. The top 3 of combined drugs were lopinavir/ritonavir (26 cases) , lamivudine (21 cases), and abacavir (14 cases). The dose of TDF was 300 mg/d in 24 patients with HIV infection, and 245 mg/d in 3 patients with HBV infection. The other patients′ dose of TDF was not reported. The time from medication of TDF to FS occurrence was 1 to 60 months in the patients with HIV infection, 3 to 45 months in the patients with HBV infection. The main clinical manifestations were diuresis (16 cases), polydipsia (10 cases), loss of weight (10 cases), fatigue (9 cases), and lower limb joint pain (8 cases), etc. The abnormities of laboratory parameters included increased serum creatinine concentration (51 cases), positive urine glucose (50 cases), positive urine protein (49 cases), decreased blood phosphate (46 cases), hypokalemia (23 cases), decreased blood bicarbonate (21 cases), increased blood urea nitrogen (12 cases), hypocalcemia (9 cases), and hyponatremia (9 cases), etc. The number of cases with acute renal failure, nephrogenic diabetes insipidus, osteoporosis, halisteresis, hypokalemic periodic paralysis, and stress fracture were 12, 7, 4, 3, 3, and 2, respectively. TDF was withdrawn in all patients after the occurrence of FS. The patients received the symptomatic treatments including intravenous hydration, supplement of potassium, phosphorus and calcium. Forty-five patients changed to use other antiviral drugs. Symptoms in 45 patients with FS were improved within 3 days to 5 months, and the laboratory indicators returned to normal within 2 weeks to 24 months. Thirteen patients′ serum creatinine concentration was still at high levels after drug withdrawal,  prescription change, and 1 to 24 months of symptomatic treatments. A patient died from severe sepsis 2 months after drug withdrawal. The results of association analysis showed that FS in 11 patients (18.6%) were probably related to TDF and in 48 patients (81.4%) were possibly related to TDF.ConclusionsThe clinical manifestations of FS due to TDF are similar to primary FS. Most of the patients can return to normal after drug withdrawal and symptomatic treatment, some patients suffer irreversible renal damage.
  • Zhang Wenjuan, Luo Junpei, Hu Yueqin
    . 2017, 19(5): 378.
    A 70-year-old female patient with motor neuron disease was given an IV infusion of ciprofloxacin 0.4 g once daily because of acute exacerbation of chronic bronchitis. On day 10, she developed hypokalemia (blood potassium 2.7 mmol/L) and potassium supplement was given. On day 11, the patient experienced loss of consciousness and cardiac arrest. The patient was given chest compression instantly and regained consciousness in three minutes. Electrocardiogram showed torsades de pointes ventricular tachycardia. Her QT corrected by heart rate (QTc) was 546 ms and blood potassium was 3.4 mmol/L. Potassium supplement was given again. On day 13, the patient′s QTc was 561 ms and blood potassium was 3.2 mmol/L. Ciprofloxacin induced QT interval prolongation was considered. On day 6 of ciprofloxacin withdrawal, the patient′s QTc was 460 ms and blood potassium was 3.9 mmol/L.
  • SARS防治
    . 2003, 5(6): 365-365.
  • 病例报告
    Zheng Jiea;Jiang Jingyub
    . 2011, 13(6): 385-2.
    A 74-year-old female patient was admitted to hospital because of hemoptysis and was given an IV infusion of vitamin K1 20 mg in 250 ml of 0.9% sodium chloride at a rate of 40 drops/min. Three minutes after the infusion started, the patient presented with palpitation, chest tightness, no response to voice stimuli, sighing respirations, and decreased breath sounds. Her heart rate was 60 times/min and blood pressure was 94/64 mm Hg. Vitamin K1 was withdrawn and she was treated with dexamethasone, epinephrine, oxygen inhalation and removing sputum by suction. However, her condition did not improve. Subsequently, the patient developed respiratory and cardiac arrest. Her blood pressure was undetectable and ventricular fibrillation occurred. The patient finally died despite resuscitation attempts.
  • 误用滥用
    Chen Shaoyuan
    . 2011, 13(3): 171-2.
    A 41-year-old man took a amphetamine-type stimulant Magu (mainly containing methamphetamine and caffeine) intermittently for more than 2 years. One year ago, he began to reduce the dose of Magu himself and then to stop taking Magu completely 4 weeks before he presented himself to clinic. Fifty days after Magu withdrawal, he developed daytime sleepiness, which occurred frequently; each episode occurred within 10-20 min and lasted for a few minutes to tens minutes. He experienced nightmare phenomenon several times. Polysomnography revealed that a mean sleep latency decreased to 80 seconds. Narcolepsy was diagnosed, which was considered to be induced by Magu withdrawal. The patient was encouraged to insist on the drug withdrawal and to enhance physical activities as well as audio-visual stimuli for avoiding daytime sleep. He was given oral amitriptyline 25 mg before going to sleep at night. Two weeks later, the patients sleep disturbances disappeared.
  • 中药不良反应
    GUO Min;ZHANG Wen;XI Ya-ming
    . 2013, 15(2): 116-2.
    A 61-year-old male patient with acute lymphoblastic leukemia received intrathecal injection of chemotherapy drugs. A doctor in charge took mistakenly the 5% sodium bicarbonate injection as solvent. After intrathecal injection, the patient presented lower limbs numbness, followed by chills, fever (peak temperature 40.1 ℃), sweating, elevated blood pressure (190-210/106-110 mm Hg), increased heart rate (170-180 beats/min), and urinary retention. The patient was given an IV infusion of methyl-prednisolone and mannitol, and at the same time, fluid supplement and urethral catheterization were given. The patient′s temperature, blood pressure, and heart rate returned to normal 4 hours later, numbness of lower limbs disappeared 6 hours later, and urinated on himself 12 hours later. There was no similar symptoms recurrence at one-week follow up.
  • 不良事件
    . 2005, 7(6): 463-463.
  • 不良事件
    . 2006, 8(2): 146-146.
  • ADR术语
    . 2003, 5(3): 210-212.
  • 药物警戒
    . 2002, 4(6): 374-374.
  • 不良事件
    . 2002, 4(1): 69-69.
  • 不良事件
    . 2004, 6(4): 276-276.
  • 不良事件
    . 2004, 6(4): 252-252.
  • 不良事件
    . 2002, 4(1): 56-56.
  • Ding Qin, Yang Chendong
    Adverse Drug Reactions Journal. 2021, 23(10): 557-558. https://doi.org/10.3760/cma.j.cn114015-20210108-00034
    A 74-year-old female patient was chronically treated with insulin glargine injection, insulin aspart injection, metformin tablets, and nifedipine controlled-release tablets because of type 2 diabetes mellitus and hypertension. Due to poor blood pressure control, candesartan cilexetil 8-mg orally once daily was added. Five days later, the patient developed myalgia and fatigue. Laboratory tests showed myoglobin >2-000-μg/L, creatine kinase 8-567-U/L, creatine kinase MB 279-U/L, aspartate aminotransferase 273-U/L, lactate dehydrogenase 546-U/L, alpha hydroxybutyrate dehydrogenase 498-U/L, and positive protein and occult blood in urine. Rhabdomyolysis caused by candesartan cilexetil was considered. Then the drug was discontinued and symptomatic treatments such as rehydration, alkalinized urine, and diuretics were given. After 7 days of drug withdrawal, the patient′s symptoms were relieved, and after 10 days of drug withdrawal, the laboratory indexes such as myoglobin, creatine kinase, and aspartate aminotransferase returned to normal.
  • Yuan Heqing, Gao Lu, Shao Xiying
    Adverse Drug Reactions Journal. 2024, 26(4): 238-243. https://doi.org/10.3760/cma.j.cn114015-20230728-00565
    Ado-trastuzumab emtansine (T-DM1) is a conjugate of trastuzumab and emtansine, which is one of the options for adjuvant therapy of residual invasive lesions after neoadjuvant therapy and rescue treatment of advanced breast cancer in patients with human epidermal growth factor receprot 2(HER2) mutation. Thrombocytopenia is one of the common adverse reactions of T-DM1. The incidence of all grade of thrombocytopenia was 3.6%-38.2%, and the incidence of grade 3 and above of thrombocytopenia was 0.4%-14.3% during treatment. The risk of thrombocytopenia is higher in Asian populations, patients with prior therapy of platinum, and those with a baseline platelet count of ≤200×109/L. The mechanism of thrombocytopenia caused by T-DM1 is not clear. Attention should be paid to monitoring platelet count during treatment, and patients with thrombocytopenia should be treated according to the severity.
  • Guo Ningning, Fang Gaofei
    Adverse Drug Reactions Journal. 2024, 26(4): 244-245. https://doi.org/10.3760/cma.j.cn114015-20231016-00734
    A 64-year-old female patient received treatments such as antibacterial, analgesic, etc. due to local swelling and blisters caused by application of domestically made drug for external use for knee joint pain. After 7 days, local skin redness and swelling appeared, with scattered rashes. Anti-allergic treatments including intravenous infusion of calcium gluconate and oral desloratadine cirate were given. On the second day, the patient developed a wheal like rash all over her body, and intravenous infusion of anti-allergic drugs were continued. On the same day, the patient′s skin symptoms were improved. The patient′s systemic rash worsened again after 1.5-hours of reapplication of desloratadine cirate, and the next day, angioneurotic edema appeared. Desloratadine cirate was stopped, dexamethasone, promethazine, and other symptomatic treatments were continued. Four days later, the patient′s symptoms completely disap- peared.
  • 病例报告
    . 2004, 6(4): 225-225.
  • 不良事件
    . 2004, 6(4): 271-271.
  • 个案分析
    . 2002, 4(3): 198-199.
  • ADE简报
    . 2000, 2(3): 201-201.
  • 药事法规
    . 2002, 4(5): 309-311.
  • ADE简报
    . 2001, 3(2): 127-127.
  • 病例报告
    . 2002, 4(2): 126-126.
  • WHO信息
    . 2002, 4(6): 418-418.
  • 病例报告
    . 2000, 2(2): 122-122.
  • 病例报告
    Zong Huantaoa;Liang Xingjiana;Wu Jichunb;Zhang Yonga
    . 2011, 13(3): 196-2.
    Two patients developed anaphylactic reactions during treatment with intravesical instillation of epirubicin or pirarubicin after surgery for bladder cancer. Patient 1, a 60-year-old man, received intravesical instillation of epirubicin 50 mg in 0.9% sodium chloride 50 ml. Ten minutes after starting intravesical instillation, the patient experienced itching of both hands and feet, redness of his face and limbs, and a heart rate of 100 beats/min. Twenty minutes later, the symptoms worsened and he could not tolerate this drug. Therefore, the drug was evacuated from his bladder, and his symptoms gradually subsided. Subsequently, the patient received the second intravesical instillation of epirubicin, and the above symptoms with nausea and vomiting occurred, and then subsided again after evacuation of the drug. Patient 2, a 54-year-old man, received chemotherapy with intravesical instillation of pirarubicin 40 mg in 5% glucose 50 ml. Thirty minutes after starting intravesical instillation, the patient presented with blurry vision, generalized pruritus with wheal. The drug was evacuated from his bladder immediately and IM diphenhydramine and IM dexamethasone were given. Thirty minutes later, his symptoms improved and, one hour later, subsided.
  • 不良事件
    . 2003, 5(5): 357-357.
  • Li Ping, Li Xiaoxiao, Zhao Rongsheng
    . 2017, 19(6): 425.
    ObjectiveTo evaluate the risk factors of acute-phase reaction (APR) following the first-dose administration of zoledronic acid in osteoporotic patients.MethodsThe documents of the observational studies about risk factors of APR following the first-dose administration of zoledronic acid in osteoporotic patients were searched from correlative data base until July, 2017. The quality of the literature enrolled into the Meta-analysis was evaluated by Newcastle-Ottawa Scale (NOS), and then Meta-analysis was conducted using RevMan 5.3 software. The effective measurements were expressed as adds ratio (OR) or difference in means (MD) and 95% confidence interval (CI).ResultsA total of 17 studies involving 1 981 patients with osteoporotic and having the first-dose administration of zoledronic acid were enrolled into the Meta-analysis.  Nine hundred and seventy-nine patients had APR (APR+group) and 1 002 patients without APR (APR-group).The scores of NOS in 17 articles were all greater than or equal to 6. The results of Meta-analysis showed that the patients in the APR(+) group were significantly younger then those in the APR(-) group (MD=-3.27, 95%CI: -4.54--2.01, P<0.000 01). The incidence rate of APR in the patients who had the history of administration of nitrogenous bisphosphonates (NBP) were lower than those without history of administration of NBP, and the difference was statistically significant (OR=0.27, 95%CI: 0.17-0.41, P<0.000 01). The incidence rate of APR in the patients having the history of fracture were higher than those without history of fracture, and the difference was statistically significant (OR=2.31, 95%CI: 1.29-4.13, P=0.005). The incidence rate of APR in the patients who had analgesic-antipyretic preventability treatment were lower than those who had no analgesic-antipyretic preventability treatment, and the difference was statistically significant (OR=0.14, 95%CI: 0.05-0.37, P<0.000 1). There were no statistical correlation between the patients′ body mass index, creatinine clearance, prior calcium usage, prior calcitriol usage, sex and APR.ConclusionLow age and the history of fracture are risk factors of APR, while the histories of administration of NBP and analgesic-antipyretic preventability are the protective factors of decreasing APR.
  • Wang Xiaodan, Cao Hongfu
    . 2015, 17(5): 377.
    A 65-year-old male patient with diabetes, diabetic nephropathy, and chronic renal insufficiency received treatments of Taxus chinensis medicinal slices (10 g,once daily by mouth), insulin aspart 30 (10 U, thrice daily by subcutaneous injection), insulin glargine (10 U, once every night by subcutaneous injection), pancreatic kininogenase (40 U, once daily by mouth), thioctic acid (0.6 g, once daily by IV injection),  Haikunshenxi  capsules (海昆肾喜胶囊, 0.44 g, thrice daily by mouth),  Niaoduqing  granules (尿毒清颗粒, 5 g, thrice daily by mouth), and compound α-keto acid (4 pills, thrice daily by mouth). The patient developed nausea and vomiting  and convulsion of extremities after 1 h and 4 h of the second treatment of Taxus chinensis medicinal slices. ECG monitoring showed supraventricular tachycardia. Laboratory tests showed serum potassium 6.4 mmol/L.  Recurrent supraventricular tachycardia appeared in the patient. After 5 times of electrical cardioversion and lidocaine and amiodarone treatments, the patient′s arrhythmia was converted to sinus rhythm. Taxus chinensis medicinal slices was stopped and other treatments were continued. Supraventricular tachycardia did not recur.
  • Qiao Zihong
    . 2015, 17(5): 381.
    A 56-year-old male patient was given traditional Chinese herbal medicines in the form of decoction for arrhythmia. One week later, Squama Manitis 10 g was added into the prescriptions. The erythema, papules with itching appeared in the left leg the next day. That condition was not controlled by stopping taking Chinese herbal medicines and topical use of compound dexamethasone acetate cream. On the third day, the rash even spread to the trunk, arms and legs. The patient was given oral loratadine 10 mg once daily and vitamin C 0.3 g thrice daily. Twenty days later, the symptoms disappeared. The rash in the left leg appeared again 3 days after the patient took Chinese herbal medicines with Squama Manitis by himself. He was cured by using the same treatment.
  • Jiang Zeyu, Cai Shanglang
    . 2017, 19(6): 471.
    A 67-year-old female patient underwent the hypersensitivity test of ultravist solution before doing adrenal enhancement CT. Fifteen minutes after intravenous injection of 2 ml of ultravist solution, the patient developed palpitation, chest pain, vomiting, weakness, and hyperhidrosis. Her blood pressure was 90/60 mmHg. She was considered to have contrast agent anaphylactic shock. The patient received intravenous injection of dexamethasone 5 mg and IV infusion of 0.9% sodium chloride injection 500 ml immediately. Two minutes later, her blood pressure elevated to 145/90 mmHg, but the chest pain was not relieved. The results of electrocardiogram showed tilted elevation on ST segment in II, III, aVF leads and declivous depression on ST segment in leads I and aVL. She was diagnosed as acute myocardial infarction. The patient immediately received aspirin enteric-coated tablet 300 mg and clopidogrel hydrogen sulfate 300 mg by chewing, hypodermic injection of low-molecular-weight heparin calcium injection 4 100 U, and continuous intravenous pumping of isosorbide dinitrate injection 50 mg at speed of 2 mg/h. One hour later, the patient′s thoracalgia was remission. She received the treatments of anti-coagulation, stable plaque, anti-hypertension, and expanding coronary artery sequentially. Thirteen days later, the hypersensitive test of ultravist solution was underwent again, the patient did not show any obvious discomfort for 24 hours. It was indicated that the patient′s acute myocardial infarction appeared in the first hypersensitive test was the anaphylactoid reaction induced by ultravist solution.
  • Liu Yiqi, Zhu Liqin, Yang Wenjie
    Adverse Drug Reactions Journal. 2021, 23(1): 15-19. https://doi.org/10.3760/cma.j.cn114015-20200712-00768
    Objective To explore the clinical characteristics of daptomycin-associated eosinophilic pneumonia (EP). Methods The PubMed, Web of Science, Embase, SpringerLink, Wiley Online Library, ScienceDirect databases were searched (up to 31 May 2020). Case reports of daptomycin- associated EP were collected. The patient′s general situation, daily dose of daptomycin, time of EP occurrence, clinical manifestations, auxiliary examination, and the treatment and outcome were recorded into a self-designed Excel data sheet. The clinical characteristics of daptomycin-associated EP were analyzed by descriptive statistical method. Results A total of 31 articles of case reports were collected, reporting on 43 patients with daptomycin-associated EP. The 43 patients includeed 36 males (83.7%) and 7 females (16.3%). the patients′ ages ranged from 28 to 89 years, of which 34 (79.1%) were ≥60 years old and 37 (86.0%) were suffering from diseases such as acute and chronic kidney disease, cardiovascular disease, diabetes, and etc. The daily dose of daptomycin in 6 patients exceeded the recommended dose in the drug instruction. The time from application of daptomycin to onset of EP was 4 hours to 8 weeks, and 37 (86.0%) of them were less than or equal to 4 weeks. The main clinical manifestations were fever (97.7%, 42/43) and dyspnea and hypoxemia (81.4%, 35/43), and cough (51.2%, 22/43), and artificial assisted ventilation was used in 30.2% (13/43) of patients due to respiratory failure. Forty-three patients had new invasive lesions in the lungs on chest imaging. Forty patients described peripheral blood eosinophil test results, and 39 (97.5%) had increased eosinophil proportion and/or count. Bronchoalveolar lavage fluid was performed in 27 patients and 17 (63.0%) had eosinophils >5%. After the diagnosis of EP, all 43 patients stopped using daptomycin. and received symptomatic treatments including oxygen inhalation, artificial assisted ventilation, defervescence, and cough suppression. Of them, 29 patients received glucocorticoid therapy. All the patients′ symptoms were improved significantly within 1-2 weeks and chest imaging returned to normal within 1-3 months. Conclusions Daptomycin-associated EP mostly occurred within 4 weeks of treatment, mostly in elderly and male patients. Although the symptoms were severe, the prognosis was good when the drug was stopped in time.
  • Liu Chen, Gai Di, Yan Suying, Wang Yuqin, Cui Xiaohui, Zhang Yangxin
    Adverse Drug Reactions Journal. 2020, 22(4): 247-251. https://doi.org/10.3760/cma.j.cn114015-20190910-00753
    Objective To investigate the occurrence of drug-induced acute kidney injury (AKI) in adult hospitalized patients in Xuanwu Hospital, Capital Medical University. Methods All medical records of adult inpatients who were discharged from January 1, 2014 to December 31, 2014 and whose diagnosis were in accordance with AKI during their hospitalization in Xuanwu Hospital, Capital Medical University were collected. The patients were divided into drug-induced AKI group and non-drug-induced AKI group according to whether AKI was caused by drugs. Basic information, comorbidity, change in serum crea- tinine (Scr), disease outcome, nephrotoxic medication exposure, and evaluation of the relationship between drugs and AKI of the patients were collected and retrospectively analyzed. Results A total of 592 patients enrolled in the study, including 138 (23.31%) in the drug-induced AKI group and 454 (76.69%) in the non-drug-induced AKI group. The differences in gender, age, days in hospital, comorbidity, Scr level on admission, time for Scr level to peak after admission, and outcome between the patients in the 2 groups were not statistically significant, respectively (P>0.05 for all). Peak value of Scr during hospitalization and at discharge in patients in the drug-induced AKI group (178-μmol/L, 116-μmol/L) were obviously higher than those in the non-drug-induced AKI group (129-μmol/L, 103-μmol/L), and the differences were statistically significant (P<0.001,P=0.001). A total of 231 times of suspected drugs were involved in the 138 patients in the drug-induced AKI group. The top 6 types of drugs in turn were anti-infectious agents (35.06%, 81/231), diuretics (17.32%, 40/231), contrast agents (13.42%, 31/231), plasma substitutes (9.96%, 23/231), angiotensin converting enzyme inhibitors/angiotensinⅡreceptor blocker (8.23%, 19/231), and non-steroidal anti- inflammatory drugs (NSAIDs) (6.93%, 16/231). Contrast agents and plasma substitutes had the shortest (range: 1-3 days) but anti-infectious agents had the longest time (range: 1-12 days) from medication to AKI occurrence. Peak values of Scr in AKI inpatients caused by NSAIDs and contrast agents were lower [median value: 118 (103, 300) μmol/L, 133 (90, 243) μmol/L], but in those caused by anti-infectious agents was the highest [median value: 223 (138, 396) μmol/L]. Multivariate logistic regression analysis showed that hypoproteinemia (OR=8.369, 95%CI: 3.379-20.724, P<0.001) and advanced age (OR=1.689, 95%CI: 1.206-2.365, P=0.002 for every 10 years of aging) were independent risk factors related to the death of patients with drug-induced AKI. Conclusions The patients with AKI induced by drugs accounts for 23.31% of all AKI adult inpatients in Xuanwu Hospital, Capital Medical University. Anti-infectious agents, diuretics, and contrast agents are the most common suspected pathogenic drugs. Hypoproteinemia and advanced age are independent risk factors for hospital deaths in drug-induced AKI patients.
  • Guo Ruipeng, Zhang Guoxiang, Shen Xuliang
    Adverse Drug Reactions Journal. 2020, 22(9): 535-536. https://doi.org/10.3760/cma.j.cn114015-20190722-00599
     A 62‑year‑old male patient with chronic myelogenous leukemia (chronic phase) received nilotinib 400 mg twice daily. The patient developed mild fatigue, precordial discomfort, and chest tightness 5 hours after the first medication, which were relieved after rest. One hour after the second medication on the same day, the symptoms of precordial discomfort and chest tightness recurred, and they were relieved after rest again. One hour after taking the medicine again the next day, the above symptoms recurred and were aggravated, which could not be relieved after rest. Laboratory tests showed that serum troponin I was 2.67 μg/L, myoglobin was 195.1 μg/L, and creatine kinase MB was 37.7 μg/L. Electrocardiogram (ECG) showed that ST segment depression was >0.1 mV in leads I, II, III, aVL, aVF, and V1‑V6, T-wave inversion, and QT/QTc was 350/402 ms. The patient was diagnosed as having acute non‑ST segment elevation myocardial infarction, which was considered to be related to nilotinib. After 3 weeks of drug withdrawal and vasodilator and anticoagulant therapy, the laboratory tests showed that serum troponin I was not detected, myoglobin was 21.7 μg/L, and creatine kinase MB was 0.8 μg/L. ECG examination showed ST segment depression and T-wave inversion disappeared in leads I, II, III, aVL, aVF and V1‑V6, and QT/QTc was 370/376ms.
  • Adverse Drug Reactions Journal. 2020, 22(12): 720-720. https://doi.org/10.3760/cma.j.cn114015-20201116-01135
  • Li Yulong, Zhao Shaopan, Fu Shihui, Luo Leiming
    Adverse Drug Reactions Journal. 2021, 23(4): 178-183. https://doi.org/10.3760/cma.j.cn114015-20201230-01298
    Objective To investigate the effects of contrast-induced nephropathy (CIN) and/or perioperative myocardial injury (PMI) on the short-term prognosis of patients after percutaneous coronary intervention (PCI). Method The study was designed as a prospective cohort study. The subjects were selected from patients with acute coronary syndrome (ACS) who underwent PCI in the Department of Cardiology, the First Medical Center, General Hospital of Chinese people′s Liberation Army from August to October 2015. According to the occurrence of CIN and PMI after operation, the patients were divided into 4 groups: no injury group, CIN group, PMI group, and CIN+PMI group. The patients were followed up for 12 months, and the end point was the main adverse cardiovascular events (MACE). The differences in basic characteristics (sex, age, ACS type, underlying diseases, past medical history, etc.), the preoperative levels of serum creatinine, triglyceride, low density lipoprotein cholesterol, fasting blood glucose, high sensitivity troponin T (hs-cTnT), creatine kinase (CK)MB, C-reactive protein, and N terminal pro-B type natriuretic peptide (NT-proBNP), levels of serum creatinine, hs-cTnT, CK-MB, and NT-proBNP within 48-hours after operation, and the occurrence of MACE were compared in patients among the 4 groups. The effects of CIN and/or PMI on the occurrence of MACE within 12 months after operation were analyzed using COX multivariate regression model. Results A total of 299 patients were included in the cohort study, including 216 males (72.2%) and 83 females (27.8%), with an average age of 60 years (range, 26-84 years). Of them, 125 patients (41.8%) were with ST segment elevation myocardial infarction (STEMI). One hundred and eighty-two patients (60.9%), 18 patients (6.0%), 79 patients (26.4%), and 20 patients (6.7%) were included in the non-injury group, CIN group, PMI group, and CIN+PMI group, respectively. The incidence of CIN in all patients was 12.7% (38/299) and that of PMI was 33.1% (99/299). No subjects were lost during the 12-month follow-up. Of the 299 patients, 24-subjects had 26 times of MACE [cardiogenic death, nonfatal myocardial infarction (NF-MI), target vessel revascularization (TVR), and stroke occurred 3, 5, 5, and 13 times, respectively] and the incidence of MACE was 8.0%. The incidences of MACE in the no injury group, CIN group, PMI group, and CIN+PMI group were 1.6% (3/182), 11.1% (2/18), 11.4% (9/79), and 50.0% (10/20), respectively, and the difference among groups was statistically significant (P<0.001). The results of COX multivariate regression analysis showed increased risk of MACE in the other 3 groups [hazard risk (HR)=6.897, 95%confidence interval (CI): 1.152-41.281,P=0.034;HR=7.623,95%CI: 2.063-28.167,P=0.002; HR=43.087, 95%CI: 11.817-157.098, P<0.001) compared with the non-injury group. Conclusion Both CIN and PMI can increase the risk of MACE in patients within 12 months after PCI treatment, which can be further increased in the coexistence of them.
  • Zhao Yi, Huang Xu, Li Xiaoxia
    . 2015, 17(5): 379.
    A 28-year-old female patient with systemic lupus erythematosus received treatments with prednisone, hydroxychloroquine, leflunomide, calcium carbonate  D3, and celecoxib. After 1 month of treatments, she developed itching over whole body, edema of eyelids and face, and generalized urticarial eruption. All drugs were discontinued and methylprednisolone, ebastine, and cetirizine hydrochloride were given. Two weeks later, skin rashes completely disappeared. However, the itching appeared again when the patient was given hydroxychloroquine treatment again for 1 week and disappeared after the drug withdrawal. After that, leflunomide, calcitriol, and calcium carbonate D3 were given again and no rashes recurred.
  • An Xiang, Gao Jingfei, Ding Xuansheng
    . 2016, 18(4): 249.
    ObjectiveTo compare the "dose-time-toxicity" relationship of acute liver injury in mice induced by a single-dose of Chaiqin Qingning capsule or Ganmaoling capsule.Methods"Time-toxicity" study: the mice were divided into 19 subgroups (10 mice in each subgroup), including 9 Chaiqin Qingning capsule subgroups, 9 Ganmaoling capsule subgroups, and 1 normal control group (treated with distilled water). The mice in the Chaiqin Qingning capsule group were treated with a single intragastric administration with 1.65 times of clinically equivalent dose (ED) (equal to 95.42 times of 70 kg normal adult daily dose) of the drug suspension. The mice in the Ganmaoling capsule group were treated with a single intragastric administration with 1.554 times of ED (equal to 52.53 times of 70 kg normal adult daily dose) of the drug suspension. The mice in the Chaiqin Qingning capsule group and Ganmaoling capsule group were divided into 1 h, 2 h, 4 h, 8 h, 12 h, 24 h, 48 h, 72 h and 96 h subgroups after administration, respectively. "Dose-toxicity" study: the mice were divided into 13 subgroups (10 mice in each subgroup), including 6 Chaiqin Qingning capsule subgroups (according to dose, the mice were divided into ED, 1.6ED, 1.62ED, 1.63ED, 1.64ED and 1.65ED subgroups; 351.00, 561.60, 898.56, 1 437.70, 2 300.31 and 3 680.50 mg/kg, respectively), 6 Chaiqin Qingning capsule subgroups (according to dose, the mice were divided into ED, 1.55ED, 1.552ED, 1.553ED, 1.554ED and 1.555ED subgroups; 390.00, 604.50, 936.98, 1 452.31, 2 251.08 and 3 489.18 mg/kg, respectively), and 1 normal control group (treated with distilled water). "Time-toxicity" was studied at different times after the drugs administration and "dose toxicity" was studied at 12 h after administration. General state and body weight of mice were observed. The changes of the levels of ALT, AST, and ALP in serum and organ index of liver, spleen, and thymus were tested.ResultsThe difference of serum levels of ALT, AST, and ALP and liver, spleen, and thymus organ index of mice between the 9 different time subgroups and the 6 different dose subgroups in Chaiqin Qingning capsule group and the normal control group were not statistically significant (all P>0.05). The ALT, AST, and ALP levels in the 2 h, 4 h, 8 h, 12 h, and 24 h subgroups and the 1.553ED, 1.554ED, and 1.555ED subgroups, the serum levels of ALT in the 48 h subgroup, the serum levels of ALT and AST in the 1.552ED subgroup, and liver organ index in mice in the 8 h and 12 h subgroups and the 1.553ED, 1.554ED, 1.555ED subgroups in the Ganmaoling capsule group were significantly higher than those in the normal control group (P<0.05, P<0.01). The serum levels of ALT, AST, ALP, and liver organ index in the 12 h subgroup were the highest in the "time-toxicity" study [(1 017.0±342.6) U/L, (281.3±60.1) U/L, (171.8±43.5) U/L, (6.76±0.60) g/100 g], and the serum levels of ALT, AST, ALP, and liver organ index in the 1.555ED subgroup were the highest in the "dose-toxicity" study [(2 930.6±661.5) U/L, (888.8±180.6) U/L, (392.7±42.4) U/L, (7.21±1.12) g/100 g].ConclusionsA single large dose of Chaiqin Qingning capsule did not induce significant hepatotoxicity in mice. A single large dose of Ganmaoling capsule could induce acute liver injury in mice and showed a significant "dose-time-toxicity" relationship.
  • Diao Li, Lyu Zenglu, Wang Shumei
    . 2016, 18(2): 143.
    A 57-year-old male with cerebral infarction received an IV infusion of safflower yellow pigment sodium chloride injection. After about 20 minutes of treatment on day 2, he presented with eye conjunctiva and nasal mucosa, accompanied by dyspnea. The drug  injection was stopped immediately and oxygen inhalation, intramuscular injection of diphenhydramine 20 mg, and IV injection of dexamethasone 5 mg, methylprednisolone 40 mg, and furosemide 20 mg were given. Safflower yellow pigment sodium chloride injection-induced angioneurotic edema was considered. Other treatments except safflower yellow pigment sodium chloride injection were continued and above mentioned symptoms did not recur.
  • 病例报告
    . 2007, 9(1): 53-54.
  • 安全信息
    . 2013, 15(2): 114-1.
  • . 2013, 15(3): 121-2.
  • 病例报告
    SUN Zhen-xiao;SUN Bo;YU Xiang-fen
    . 2012, 14(2): 124-1.
    A 34-year-old woman received oral mirtazapine 15 mg once daily for depression. Four days later, the dose of mirtazapine was increased to 30 mg once daily. On day 14, the patient presented with galactorrhea. Mirtazapine was withdrawn and citalopram was given. After 6 days, her galactorrhea disappeared. Ten days later, the patient self-medicated with mirtazapine 15 mg once daily for insomnia. On day 8, the galactorrhea recurred. Six days after cessation of the drug, her symptoms disappeared.
  • 论著
    LI Liu-shui;LIU Min;MENG Ru-song;LI Zhong-dong
    . 2012, 14(6): 360-5.

    ObjectiveTo study the effect of cytochrome C on accumulation of etimicin in rat kidney and its renal tubular toxicity. Methods Forty-eight specific pathogen free male Wistar rats were divided into 8 groups according to random number table, including the vehicle control group, the cytochrome C group, the etimicin 10 mg/kg group, the etimicin 10 mg/kg plus cytochrome C group, the etimicin 30 mg/kg group, the etimicin 30 mg/kg plus cytochrome C group, the etimicin 100 mg/kg group, and the etimicin 100 mg/kg plus cytochrome C group; each group contained 6 rats. Rats in the vehicle control group received intraperitoneal injection of normal saline solution. Rats in the cytochrome C group received intraperitoneal injection of cytochrome C 100 mg/(kg·d). Rats in the etimicin alone groups received intraperitoneal injection of etimicin 10, 30, 100 mg/(kg·d), respectively. The rats in the three groups receiving etimicin plus cytochrome C initially received intravenous injection of cytochrome C 100 mg/(kg·d) via a tail vein and, about 30 minutes later, received intraperitoneal injection of etimicin 10, 30, 100 mg/(kg·d), respectively. The rats in each group continuously received drugs for three days and, 24 hours after the last injection, they were sacrificed and their bilateral kidneys were removed. The amount of etimicin accumulated in the kidney was measured using high-performance liquid chromatography, renal tubular epithelial cell apoptosis was detected by terminal-deoxynucleotidyl transferase mediated nick end labelling technique, and the positive number density of apoptotic cell was calculated by computer map analysis system. ResultsThe etimicin concentration in the tissue of rat kidneys was as follows: in the etimicin 10, 30, and 100 mg/kg groups, the contentration was (69.3±16.9), (221.8±66.8), and (305.9±35.5) μg/g, respectively; in the etimicin plus cytochrome C groups, the concentration was (39.0±18.4) (P<0.05), (121.5±34.2) (P<0.05), and (266.7±43.7) μg/g, respectively. The positive number density of apoptotic renal tubular epithelial cells in rats was as follows: in the etimicin 10, 30, and 100 mg/kg groups, the density was (266.8±15.4)/mm2, (527.7±208.7)/mm2, and (528.8±145.3)/mm2, respectively; in the etimicin plus cytochrome C groups, the density was (97.2±15.4)/mm2 (P< 0.01), (162.4±36.6)/mm2 (P< 0.01), and (472.5±70.1)/mm2, respectively. ConclusionCytochrome C can inhibit etimicin-induced renal tubular toxicity by inhibiting accumulation of etimicin in kidney.

  • 病例报告
    FENG Tie-zhu;LI Jian-ming
    . 2012, 14(6): 378-2.
    A 24-year-old male patient with severe hepatitis B received oral lamivudine 100 mg once daily and oral silibinin 70 mg thrice daily; at the same time, he was given an IV infusion of reduced glutathione 1.2 g, compound glycyrrhizin 80 ml and hepatocyte growth-promoting factor 120 mg once daily. One week later, his red blood cell count decreased from 4.52×1012/L to 3.29×1012/L and his hemoglobin level decreased from 120 g/L to 102 g/L. Three weeks later, repeat testing showed the followed levels: red blood cell count 3.00 ×1012/L, hemoglobin 81 g/L. Lamivudine was discontinued and his treatment was switched to entecavir 0.5 mg once daily, while other medications remained unchanged. After 16 days, a repeat routine blood test showed a red blood cell count of 3.84×1012/L and a hemoglobin level of 120 g/L.
  • 不良事件
    . 2003, 5(6): 414-414.
  • 国外文献题录
    . 2004, 6(3): 201-202.
  • ADR术语
    . 2004, 6(3): 206-207.
  • 不良事件
    . 2002, 4(2): 95-95.
  • 不良事件
    . 2004, 6(2): 136-136.
  • 不良事件
    . 2003, 5(2): 125-125.
  • 药物滥用
    . 2006, 8(6): 439-440.
  • 中药不良反应
    . 2006, 8(6): 461-462.
  • Xi Qing, Li Ruirui
    Adverse Drug Reactions Journal. 2022, 24(4): 211-213. https://doi.org/10.3760/cma.j.cn114015-20210616-00683
    A 73-year-old female patient with central squamous cell carcinoma of left lung received one dose treatment of IV infusion of nivolumab 200-mg. On the 16th day after nivolumab treatment, the patient developed left eyelid ptosis and shortness of breath. Laboratory tests showed creatine kinase (CK) 21-378-U/L, CK-MB 529-U/L, N-terminal pro-B-type natriuretic peptide (NT-BNP) 8-783-ng/L, alanine aminotransferase (ALT) 350-U/L. On the 25th day after nivolumab treatment, laboratory tests showed high-sensitivity human troponin T (hs-cTnT) 1-722-ng/L, NT-BNP 2-385-ng/L, white blood cell count (WBC)was 18.5×109/L, neutrophil count was 17.9×109/L, serum free triiodothyronine (FT3) 2.66-pmol/L, thyroid stimulating hormone (TSH) 0.16 mU/L, thyroid peroxidase antibody (TPO-Ab) 61-U/ml, and thyroglobulin antibody (TG-Ab) 62-U/ml. Nivolumab-related immune myositis, myocarditis, pneumonia, and abnormal thyroid function and liver function were considered. Glucocorticoid, anti-infection, and anti-arrhythmia treatments, etc. were given. Seven days later, sinus rhythm in the patient was recovered, hs-cTnT decreased to 847-ng/L, ALT and aspartate aminotransferase were 51-U/L and 31-U/L, respectively; 34 days later, WBC was 6.8×109/L and neutrophils percentage was 0.70; 37 days later, the patient returned to spontaneous breathing; 49 days later, the patient′s muscle strength recovered significantly, NT-BNP was 185-ng/L, and hs-cTnT was 687-ng/L. Except that TSH was 16.03 mU/L, other indexes related to thyroid returned to the reference value range.
  • Yang Shilei, Li Lu, Zhu Yanna, Zhai Xiaohan, Lyu Linlin, Chen Yanwei, Xi Yan, Liu Jie, Tao Xufeng, Li Shuai, Tang Jingya, Li Yunming, Dong Deshi
    Adverse Drug Reactions Journal. 2023, 25(3): 145-151. https://doi.org/10.3760/cma.j.cn114015-20221107-01034
    Objective To compare the efficacy and safety of ticagrelor tablets produced by Zhejiang Hisun Pharmaceutical Co., Ltd. (the generic drug) and ticagrelor tablets produced by AstraZeneca Pharmaceutical Co., Ltd. (the original drug) in antiplatelet therapy. Methods The study design was a retrospective cohort study. The subjects were patients who underwent percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) and postoperative antiplatelet therapy with ticagrelor tablets at First Affiliated Hospital of Dalian Medical University during January 2020 to July 2021. Through the hospital electronic medical record system, relevant clinical data of patients (age, gender, comorbidities, blood lipid level on admission, PCI indications, antiplatelet treatment regimen, efficacy and safety assessment endpoint events within 12 months of treatment, etc.) were collected. The patients were divided into the generic drug group and the original drug group. To exclude confounders, propensity score matching (PSM) method was used. The efficacy evaluation index was the incidence of the primary endpoint events (cardiogenic death, stroke, target revascularization, recurrent infarction) and secondary endpoint events (all-cause mortality, peripheral artery occlusion, stent thrombosis, angina attacks) within 12 months of treatment. The safety evaluation index was the incidence of bleeding event within 12 months of treatment. Results A total of 1-486 patients were included in this study, including 734 in the generic drug group and 752 in the original drug group. The proportion of women and unstable angina, and the level of high-density lipoprotein cholesterol were higher than those in the original drug group (all P<0.05). The proportion of patients with hyperlipidemia and ST-segment elevation myocardial infarction were lower than those in the original drug group (both P<0.05). After PSM, 690 patients were enrolled in the generic drug group and 690 patients in the original drug group (all P>0.05). No differences in the comparison of clinical features between the 2 groups was significant(all P>0.05). No differences in the incidences of primary endpoints, secondary endpoints, and bleeding events between the 2 groups was significant before and after PSM [before PSM: 12.1%(89/734) vs. 10.9%(82/752), 10.8%(79/734) vs. 8.4%(63/752), 0.3%(2/734) vs. 0.5%(4/752); after PSM: 12.6%(87/690) vs. 12.3%(85/690), 11.0%(76/690) vs. 8.3%(57/690), 0.3%(2/690) vs. 0.4%(3/690); all P>0.05]. No death occurred in patients of both groups. Bleeding is predominantly characterized by epistaxis and subcutaneous petechiae, which did not lead to interruption of antiplatelet therapy. Conclusion The efficacy and safety of ticagrelor tablets produced by Zhejiang Hisun Pharmaceutical Co., Ltd. for antiplatelet therapy in ACS patients after PCI surgery were basically the same as those of the original drug.
  • Yilimire·Abudouwaili, Zhang Haiying, Zhao shengjun
    Adverse Drug Reactions Journal. 2023, 25(5): 263-270. https://doi.org/10.3760/cma.j.cn114015-20220914-00841
    Objective To explore the toxicities and their toxic sites of 5 species of Ferula sinkiangensis K.M. Shen, including Ferula songarica (F. songarica), Ferula feruloides (F. feruloides), Ferula akitschkensis (F. akitschkensis), Ferula dissecta (F. dissecta), and Ferula syreitschikowii (F. syreitschikowii) in vitro experiments. Methods Five ethanol extracts of Ferula sinkiangensis K.M. Shen were prepared using 95% ethanol reflux method. The 5 ethanol extracts were added to human embryonic kidney epithelial cells (HKC), human normal liver cells (L02 cells), and zebrafish embryo culture medium at 5 different concentrations, respectively. The relevant blank group and normal control group were set up meanwhile. The inhibition rates of HKC and L02 proliferation at 24-hours of culture under 37.0-℃ and survival rates of zebrafish embryos at 24, 48, and 72-hours of culture under 37.0-℃ were calculated. The most toxic specie of the 5 Fragrant Ferula L. was selected and the extracts from different polar parts (petroleum ether, dichloromethane, ethyl acetate, water saturated n-butanol, and water parts) were prepared for the above mentioned cytotoxicity and zebrafish embryotoxicity tests to clarify the toxicities. Results Cytotoxicity tests showed that among 5 ethanol extracts of Fragrant Ferula L., the half inhibitory concentration (IC50) of the F. songarica (70.92-μg/ml and 42.33-μg/ml) to HKC and L02 cells were lowest, and the IC50 of F. feruloides (107.80-μg/ml and 97.92-μg/ml) were highest. The zebrafish embryotoxicity test showed that at concentration of 1.0-μg/ml, embryonic death occurred when cultured 48-hours in the F. songarica group, with a survival rate of 70% (14/20), while it had a survival rate of 100% (20/20) in the other 4 groups; at concentration of 10.0-μg/ml, the embryo survival rate in the F. feruloides group was 50% (10/20) when cultured 24-hours, while it had a survival rate of 0 (0/20) in the other 4 groups. Cytotoxicity tests were conducted using extracts from the petroleum ether, dichloromethane, ethyl acetate, water saturated n-butanol, and water parts of F. songarica, the IC50 of the petroleum ether parts (77.35-μg/ml and 67.73-μg/ml) to HKC and L02 cell proliferation were the lowest and of the water parts (731.52-μg/ml and 364.09-μg/ml) were the highest. In the zebrafish embryotoxicity test, the survival rate of zebrafish embryos in the petroleum ether group was the lowest. The survival rate was 50% at concentration of 3.0-μg/ml for 72-hours′ culture and at concentration of 10.0-μg/ml for 24-hours′ culture. The survival rate was 0 at concentration of 10.0-μg/ml for 48 and 72-hours′ culture, as well as at 30.0-μg/ml at all observation times. Conclusions Among the 5 Ferula sinkiangensis K.M. Shen, the toxicity of F. songarica is relatively high, while that of F. feruloides is relatively low. The toxic parts of F. songarica may mostly accumulate in petroleum ether parts.
  • 不良事件
    . 2003, 5(4): 269-269.
  • 不良事件
    . 2004, 6(4): 272-272.
  • ADE简报
    . 2001, 3(1): 53-53.
  • 病例报告
    . 2002, 4(5): 343-343.
  • 不良事件
    . 2003, 5(1): 56-56.
  • 不良事件
    . 2006, 8(2): 116-116.
  • 病例报告
    . 2002, 4(4): 263-263.
  • 不良事件
    . 2004, 6(3): 196-196.
  • 不良事件
    . 2005, 7(3): 220-220.
  • 病例报告
    LI Si-zhao;ZHAO Yi;YU Nai-chang;LI Xiao-xia
    . 2012, 14(3): 172-2.

    An 81-year-old man with aggravated rheumatoid arthritis received subcutaneous injection of recombinant human tumor necrosis factor-α receptorⅡ:IgG Fc fusion protein 25 mg twice weekly and oral methotrexate 10 mg once weekly. Thirteen months later, a painless mass was found in his left submandibular region. The man underwent surgical excision of his mass. Adenolymphoma was confirmed by pathological examination. The recombinant human tumor necrosis factor-α receptorⅡ:IgG Fc fusion protein and methotrexate were discontinued and he had no recurrence of lymphoma at an eight-month follow-up.

  • 中药不良反应
    Zhou Yu;Wu Kunfeng
    . 2011, 13(5): 325-2.

    A 11-year-old girl took a decoction about 300 ml equivalent to 3 flowers of Datura metel for oral ulcers. After two hours, she developed agitation, followed by frequent waking during the night. An examination showed hallucination, lack of insight, disorientation. Her ECG showed sinus tachycardia. Her symptoms were considered to possibly be associated with hyoscyamine contained in datura flower. She was given an IV infusion of glucose and sodium chloride 500 ml once daily, oral diazepam 2.5 mg twice daily. On day 3 of treatment, her symptoms disappeared.

  • ADE简报
    . 2000, 2(1): 59-59.
  • . 2017, 19(1): 1-2.
  • 安全信息
    . 2014, 16(4): 197-1.
  • Cao Chang, You Limin, Du Jiangtao, Gan Hexia, Cai Jiawei, Shi Tao
    . 2018, 20(1): 71.
    A 67-year-old female patient with severe osteoporosis received an intravenous infusion of zoledronic acid injection 5 mg (100 ml). Twenty-four hours later, the patient developed conjunctival congestion in bilateral eyes, blurred vision, and difficult lifting of the right eyelid. Ofloxacin eye drops and polyethylene glycol eye drops were given, but the above symptoms were not improved markedly. On the 3rd day of zoledronate acid injection, conjunctivitis with blepharoptosis was diagnosed by an ophthalmologist. On the 4rd day, tobramycin dexamethasone eye drops and esculin and digitalisglycosides eye drops were given. Eight days later, the patient′s eyes discomfort disappeared. It was considered that conjunctivitis with blepharoptosis was induced by zoledronic acid injection.
  • Zeng Na, Sun Huajun
    Adverse Drug Reactions Journal. 2019, 21(5): 399-400. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.022
    A 4-year-old boy with influenza A virus infection and pharyngitis received oral oseltamivir phosphate capsules 30 mg twice daily, compound pholcodine oral solution 4 ml thrice daily, and paracetamol oral suspension 4 ml as required according to the doctor′s advice. About 10 and 13 hours after the first administration of oseltamivir phosphate capsules, the boy suddenly woke up from sleep at night, closed his eyes, clenched his hands, and shouted. The above symptoms lasted about 20 minutes. About 6, 14 and 18 hours after the second administration of the drug, the above symptoms of mania appeared again. It was considered that the mania was related to oseltamivir phosphate capsules. Oseltamivir phosphate capsules were stopped and the other drugs were continued. The symptoms of mania did not recur in the boy since then.
  • Fu Zhengran, Wang Xiaoling, Fang Fang
    Adverse Drug Reactions Journal. 2019, 21(6): 431-434. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.006
    ObjectiveTo understand the incidences of adverse reactions on cognition, language, and bone metabolism  related to 8 commonly used antiepileptic drugs in China using SIDER database.MethodsThe integrated incidences of adverse reactions on cognition, language, and bone metabolism related to 8 commonly used antiepileptic drugs (carbamazepine, oxcarbazepine, valproate, clonazepam, lamotrigine, levetiracetam, topiramate, and zonisamide) marketed in China was searched in the SIDER database.ResultsThe main drugs that affected cognition were topiramate and valproate. The incidences of memory impairment caused by topiramate and abnormal thinking related to valproate were 1.2%-10.8% and 6.0%, respectively. Topiramate was the main drug that affected language. The incidences of dysarthria and speech disorder caused by topiramate were 1.6%-6.2% and 1.0%-16.8%, respectively. The main antiepileptic drugs that affected bone metabolism were carbamazepine, oxcarbazepine, and valproate. But there was no incidence information because of the limited small amount of literature reports after marketing.ConclusionsThe results of data analysis in this database indicate that different antiepileptic drugs have different effects on cognitive function, language function and bone metabolism, and the frequency of adverse reactions is different. The clinical use of antiepileptic drugs needs to weigh the advantages and disadvantages according to the specific situation of patients.
  • Song Zhaorui, Zhang Wenrui, Cao Xue, Song Yanqing, Li Yanjiao
    Adverse Drug Reactions Journal. 2020, 22(12): 683-688. https://doi.org/10.3760/cma.j.cn114015-20200511-00520
    Objective To understand the clinical characteristics of bosentan-related liver injury. Methods PubMed, Ovid, Web of Science, Embase, Springer-link, Wiley Oline Library, CNKI, Wanfang and VIP databases were searched as of April 2020 and case reports on bosentan-related liver injury were collected. General information, primary diseases, comorbidities, bosentan use, combined medication, and occurrence, treatment and outcome of liver injury in patients were extracted and analyzed by descriptive statistical method. Results A total of 10 case reports on bosentan-related liver injury were included, involving 12 patients (3 from China, 3 from Japan, 2 from Italy, and 4 from Australia, Brazil, Canada, and Sweden respectively). The 12 patients were all female, aged from 29 to 79 years with an average age of 55 years. The primary diseases were systemic sclerosis-associated pulmonary hypertension (PAH) in 5 patients, connective tissue disease-associated PAH in 2 patients, idiopathic, secondary, chronic thromboembolic, biliary cirrhosis-associated, and non-hepatic portal hypertension-associated PAH in 5 patients, respectively. Four patients had comorbidities. All the 12 patients had combined medications,which included 1-9 kinds of drug. Liver injury occurred in patients 20 days to 57 months after bosentan administration (<1 month in 3 patients, 1-3 months in 4 patients, and >12 months in 5 patients) and was manifested as elevated transaminases, accompanied by elevated bilirubin in 5 patients; the clinical manifestations in 6 patients were described, including yellow staining of skin and sclera in 4 cases, anorexia in 4 patients, nausea in 3 patients, fatigue in 3 patients, and vomiting, weight loss, and drowsiness in 3 patients, respectively; liver biopsy was performed in 1 patient, showing autoimmune hepatitis. After liver injury, bosentan was discontinued or continued with a halved dose;symptomatic treatments were given depending on the specific situation of liver injury; among the 12 patients, 9 had normal liver function, 2 had improved liver function, and 1 died of multiple organ failure. Conclusions Bosentan-related liver injury may occur within 20 days to 57 months of medication and often within 3 months, with similar clinical manifestations to those induced by other drugs. Some patients may have no clinical symptoms but only abnormal liver function while severe liver injury may occur in a small number of patients. Liver function can usually return to normal or be improved after discontinuation of bosentan.
  • Liu Haiyan, Li Tingting, He Linhai, Li Guoyun
    . 2017, 19(3): 230.
    An 8-year-old boy with acute appendicitis received an IV infusion of cefpiramide 1 g twice daily. Before treatment, the patient′s PLT was 296×109/L. On the 3rd day of treatment, PLT dropped to 15×109/L, on the 4th day, PLT decreased to 1×109/L, accompanied by melena and fecal occult blood test (++++). Cefpiramide was discontinued immediately, then comprehensive treatments including transfusion of platelets, application of hemostatic agents, and supplement of vitamin K1 were given to the patient. Four days later, PLT of the patient returned to 165×109/ L.
  • 安全信息
    . 2010, 12(5): 375-1.
  • 安全信息
    . 2010, 12(6): 448-1.
  • ADR监测
    . 2001, 3(1): 28-29.
  • 不良事件
    . 2003, 5(5): 344-344.
  • 不良事件
    . 2002, 4(2): 131-131.
  • 监测简报
    . 2004, 6(2): 127-127.
  • ADE简报
    . 2001, 3(2): 124-124.
  • 不良事件
    . 2002, 4(1): 55-55.
  • 病例报告
    . 2003, 5(3): 189-189.
  • 不良事件
    . 2003, 5(4): 270-270.
  • 监测简报
    . 2003, 5(2): 128-128.
  • 不良事件
    . 2006, 8(3): 209-209.
  • Zhang Feng, Chen Wansheng
    Adverse Drug Reactions Journal. 2024, 26(11): 647-651. https://doi.org/10.3760/cma.j.cn114015-20240802-00682
    The safety of traditional Chinese Medicine (TCM) has garnered widespread attention and has become a major obstacle to its further development and internationalization. The complexity of TCM and the unpredictability of its interactions with the human body pose significant challenges to safety research. The causes of TCM safety issues are multifaceted, including intrinsic and extrinsic toxicity, confusion of herbal sources and misuse in clinical practice, inadequate patient awareness of safe medication use, and insufficient regulatory oversight of TCM quality and safety. To strengthen the risk managements, it is essential to employ scientific technologies to investigate the fundamental nature of TCM safety, leverage artificial intelligence for big data analysis and early risk warning, promote the scientific concept of safe TCM use, and establish a comprehensive lifecycle pharmacovigilance system for TCM. These will facilitate TCM safety research in China, ensure patient medication safety, and promote the healthy and sustainable development of the TCM industry and its internationalization.
  • Long Quanhui, Zhao Xinyi, Xiao Zhu, Yang Jia
    Adverse Drug Reactions Journal. 2022, 24(4): 208-210. https://doi.org/10.3760/cma.j.cn114015-20210811-00884
    A 48-year-old woman was vaccinated with quadrivalent lytic influenza virus vaccine. Seven days later, tenderness pain and mass with tenderness pain appeared on the left side of the thyroid gland, which was diagnosed as subacute thyroiditis. The patient received celecoxib capsules 200-mg orally twice daily, external application of Pingying powder (平瘿散), and oral administration of traditional Chinese medicine decoction. The pain and mass disappeared after 21 days of treatments. One week later, similar symptoms occurred on the right side of the thyroid gland, the same dose of celecoxib capsules was given, but it was ineffective. So, it was replaced by prednisone acetate tablets 20-mg orally once daily. Twenty-five days later, the pain was relieved and the neck mass reduced. It was considered that the patient′s subacute thyroiditis was possibly due to quadrivalent lytic influenza virus vaccine.
  • Niu Xiaoqiang
    Adverse Drug Reactions Journal. 2025, 27(1): 50-52. https://doi.org/10.3760/cma.j.cn114015-20240528-00383
    A 46-year-old female patient received Tongtian oral solution 10 ml thrice daily combined with Yangxue Qingnao pills 2.5 g thrice daily for migraine. After 10 days of treatments, the patient developed yellow urine. After 12 days of treatments, the patient stopped using Tongtian oral solution by herself. After continuing to take Yangxue Qingnao pills for 5 days, the patient developed symptoms of yellowish skin and sclera, and 10 days later, Yangxue Qingnao pills were discontinued by herself. The next day of discontinuing the Yangxue Qingnao pills, the patient experienced abdominal distension. The laboratory tests showed alanine aminotransferase (ALT) 1 454 U/L, aspartate aminotransferase (AST) 1 429 U/L, gamma glutamyltransferase (GGT) 290 U/L, alkaline phosphatase (ALP) 176 U/L, total bilirubin (TBil) 94.2 μmol/L, and total bile acid (TBA) 365.9 μmol/L. Based on the patient′s medical history, laboratory test results, and auxiliary examinations, drug-induced liver injury was diagnosed, which might be related to Tongtian oral solution and Yangxue Qingnao pills. After one week of Yangxue Qingnao pills withdrawal, the patient′s symptoms of yellowish skin and sclera were improved and urine color became lighter, with ALT 495 U/L, AST 202 U/L, GGT 181 U/L, ALP 120 U/L, TBil 24.6 μmol/L, and TBA 15.6 μmol/L. After 7 days of treatments such as magnesium isoglycyrrhizinate, hepatocyte growth-promoting factor, and ademetionine, the patient′s condition was significantly improved. The above-mentioned drugs were discontinued and switched to bicyclol 25 mg thrice daily orally. Eight days later, the patient′s liver function indicators had basically returned to normal.
  • Jin Mei, Wang Qian, Gao Shuang, Zhao Jingwen, Chen Xiaofeng, Wang Youyu, Qiao Qingbo
    Adverse Drug Reactions Journal. 2023, 25(1): 40-46. https://doi.org/10.3760/cma.j.cn114015-20220726-00679
    Objective To compare the efficacy and safety of ticagrelor and clopidogrel in antiplatelet aggregation after 2-staged hybrid coronary revascularization (HCR). Methods A prospective randomized controlled trial was conducted. According to the postoperative antiplatelet therapy scheme, the patients with coronary artery multivessel disease who underwent 2-staged HCR operation in our hospital were divided into ticagrelor group (after the operation, the patients were given aspirin enteric coated tablets 100-mg orally once daily and ticagrelor tablets 90-mg orally twice daily for 1 year) and clopidogrel group (after the operation, the patients were given aspirin enteric coated tablets 100-mg orally once daily and tica- grelor tablets 75-mg orally once daily for 1 year). The general condition, platelet aggregation funtion [maximum platelet aggregation rate (MPAR) and P2Y12 reaction unit (PRU)] at different time points before and after operation, and platelet inhibition rate [aspirin resistance (AA), ticagrelor or clopidogrel resistance (ADP)], major adverse cardiovascular events (MACE), bleeding events, and adverse reactions after operation were analyzed and compared between the 2 groups. Results A total of 124 patients were enrolled in the study, 62 patients each in the ticagrelor group and clopidogrel group. There were no statistically significant differences in baseline data (gender, age, New York Heart Association cardiac function classification, concomitant diseases, etc.) between the 2 groups (all P>0.05). The MPARs at 24-h, 7 d, and 1 month after operation in the ticagrelor group and clopidogrel group were lower than those before operation [(50±9)%, (36±8)%, (29±6)% vs. (65±11)% and (59±10)%, (47±9)%, (38±7)% vs. (65±12)%, all P<0.001]. The MPARs at 24-h, 7 d, and 1 month after operation in the ticagrelor group were lower than those in the clopidogrel group[(50±9)% vs. (59±10)%, (36±8)% vs. (47±9)%, (29±6)% vs. (38±7)%, all P<0.001]. The PRUs at 24-h, 7 d, and 1 month after operation in the 2 groups were lower than those before operation (all P<0.001). The PRUs at 24-h, 7 d, and 1 month after operation in the ticagrelor group were lower than those in the clopidogrel group(all P<0.001). There was no significant difference in the incidence of AA 24-hours after operation between the 2 groups (P>0.05); the inhibition rate of ADP in the ticagrelor group was higher than that in the clopidogrel group (P<0.001). At the 24th month of follow-up, the incidence of MACE in the ticagrelor group was lower than that in the clopidogrel group (11.3% vs. 27.4%, P<0.05). At the 12th month of follow-up, there was no statistically significant difference in incidence of bleeding events between the 2 groups (3.2% vs. 8.1%, P>0.05). There was no statistically significant difference in the incidence of adverse reactions between the 2 groups (16.1% vs. 11.3%, P>0.05). Conclusions Compared with clopidogrel+aspirin regimen, tica- grelor+aspirin regimen is more effective in inhibiting platelet aggregation and reducing postoperative MACE after 2-staged HCR. Both antiplatelet aggregation regimens do not increase the risk of bleeding and have no serious adverse reactions. Both regimens have good safety.
  • Wang Dayou
    Adverse Drug Reactions Journal. 2023, 25(9): 513-516. https://doi.org/10.3760/cma.j.cn114015-20230912-00680
    The theme of World Patient Safety Day 2023 is "Engaging Patients for Patient Safety". Encouraging patients (including patients′ families, caregivers, etc.) to voice in medication safety is one of the important measures of medication safety management and pharmacovigilance, which conforms to the principles of ethics and science and is adapted to the development of society. It has been widely recognized in the world that patients participate in the safety monitoring in drug clinical trial, adverse drug reaction reporting, and information communicating and safety supervising of drug safety, and act as partners with doctors and drug regulatory agencies in drug safety. China should also attach importance to and address the obstacles in patient participation in management of medication safety, and accelerate the process of patient participation in management of medication safety.
  • 病例报告
    . 2006, 8(6): 458-459.
  • 网络医药
    . 2003, 5(3): 184-186.
  • WHO信息
    . 2002, 4(2): 135-135.
  • ADE简报
    . 2001, 3(4): 248-248.
  • 病例报告
    Jia Rongdi;Xu Yao
    . 2011, 13(3): 198-2.
    A 52-year-old woman received an IV infusion of trastuzumab 220 mg dissolved in 0.9% sodium chloride 250 ml at a rate of 50 drops/min for adjuvant chemotherapy after breast cancer surgery. About 30 minutes after infusion initiation, the patient developed chills, chest tightness, lips numbness, and short of breath. Her heart rate was 165 beats/min and blood pressure was 199/99 mm Hg. The infusion was stopped immediately and symptomatic treatment was given. Fifty minutes later, the above symptoms disappeared and her heart rate and blood pressure returned to normal. Twenty-one days later, she received a second chemotherapy with an IV infusion of trastuzumab 110 mg in 0.9% sodium chloride 250 ml at a rate of 30 drops/min. Five minutes later, she presented with anaphylactoid symptoms again and, 10 minutes after drug discontinuation, her symptoms disappeared.
  • ADR咨询
    . 2005, 7(2): 155-155.
  • 不良事件
    . 2004, 6(1): 57-57.
  • 法规准则
    . 2007, 9(5): 354-356.
  • Yang Pengchun, Li Qiyi, Jiang Shizhu
    . 2017, 19(4): 295.
    A 28-year-old female developed abdominal pain about 4 hours after taking levonorgestrel tablets 3 mg for emergency contraception. Thirteen days later, the patient developed yellowish discoloration of skin and sclera, with dark urine, nausea, vomiting, and fatigue. Laboratory examination showed the following levels: aspartate aminotransferase (AST) 3 586 U/L, alanine aminotransferase (ALT) 2 478U/L, total bilirubin (TBil) 101.6 μmol/L, direct bilirubin (DBil) 65.1 μmol/L. The patient was diagnosed with acute liver injury. She was treated with liver-protective drugs such as intravenous infusions of magnesium isoglycyrrhizinate, reduced glutathione, ademetionine 1,4-butanedisulfonate, Xueshuantong (血栓通) injection, and oral ursodeoxycholic acid capsules. After 5 days, the symptoms of the patient were significantly improved, liver function tests showed the following results: ALT 902 U/L, AST 80 U/L, TBil 46.7 μmol/L and DBil 30.8 μmol/L. After 15 days, the levels of ALT, AST, and TBil were 41 U/L, 36 U/L, and 20.9 μmol/L.
  • Li Qiong, Yang Ping
    . 2017, 19(3): 182.
    ObjectiveTo explore the clinical characteristics of valproic acid-induced hyperammone-mic encephalopathy (VHE) in children.MethodsThe digital administration system of medical record in the First Hospital of Shanxi Medical University was searched. The clinical data of children who with VHE, age <16 years and hospitalized from July 2006 to July 2015 were collected and analyzed retrospectively. The main indicators of analysis included children′ clinical manifestations, treatments, blood concentration of valproate (VPA) and level of blood ammonia before and after treatment, results of electrocardiogram (ECG), video electroencephalogram (EEG), cranial computed tomography and clinical outcome.ResultsA total of 12 children were enrolled in the analysis comprising 7 boys and 5 girls with age from 10 to 15 years. The number of children with primary diseases of epilepsy, bipolar affective disorder, glioma and viral encephalitis were 5, 4, 2 and 1, respectively. The doses of VPA was 22-28 mg/kg for all cases. Seven cases were treated with VPA first time. Four cases were treated with VPA only. Eight cases received combined medications with other anti-epileptic drugs. There were 4 and 2 cases who were misdiagnosed as cerebral hemorrhage and brain edema, respectively. The 12 patients developed disorder of consciousness, drowsiness, and 7 cases developed to coma. Six cases had digestive symptoms which including nausea and vomiting before the appearance of nervous system symptoms.In addition, the number of cases with asterixis, irritability and agitation, ataxia, and frequent seizures were 4, 3, 2, and 1, respectively. The results of laboratory tests showed the children′ blood ammonia level were increased to 85-219 μmol/L, the average level was (143±47)μmol/L. Seven cases′ VPA blood concentration was 102-125 mg/L, which was the upper limit reference. The results of 12 patients′ vedio-EEG were diffused inactive echoes which mainly δ and θ wave.  After the appearance of symptom of VHE, seven cases were stopped VPA, five cases halved the dosage of VPA. All the patients received symptomatic treatments (reducing blood ammonia and intracranial decompression). On day 1 to 5 of treatments, all the patients′ symptoms were relieved, the blood ammonia levels were descended to 22-66 μmol/L. On day 7 of treatment, their VPA blood concentration were 30-63 mg/L, the rhythms of vedio-EEG recovered to α wave.ConclusionsChild′s VHE is easy to be misdiagnosed. The main clinical characteristics of child with VEH include mental confusion, drowsiness, coma, ataxia, asterixis, and frequent seizures. Some children appear digestive symptoms before the appearance of nervous symptoms. The serum ammonia level in children with VHE may not increase remarkably. The patient′s outcome is better after drug withdrawal, half the dose, and symptomatic treatments.
  • . 2017, 19(2): 151-153.
  • Huang Fangfang, Yan Huan, Deng Muhong, Li Xiuxiu
    . 2017, 19(2): 135-137.
    A 29-year-old man with malignant pheochromocytoma was treated with oral apatinib 500 mg once daily. One week later, the apatinib was decreased 375 mg once daily due to increased blood pressure. Thirty-seven days after drug administration, he developed bloody stool 50 ml and apatinib was withdrawn. Four days later, the original dosage of apatinib was given because of disease progression. On day 9, he developed bloody stool 600 ml. On day 10, he developed bloody stool 2 300 ml and vomited coffee-ground-like gastric content about 1 000 ml. He received an IV pumping of octreotide acetate, IV infusions of hydroxyethyl starch 40 sodium chloride, carbazochrome sodium sulfonate, etamsylate and aminomethylbenzoic acid. Laboratory tests revealed the following levels: RBC 1.2×1012/L, Hb 37 g/L, thrombin time 17 s, prothrombin time 22 s, D-dimer 3.3 mg/L, calcium 1.22 mmol/L, potassium 2.5 mmol/L, total protein 26 g/L, albumin 15 g/L, creatinine 12 μmol/L, uric acid 29 μmol/L. Apatinib induced acute gastrointestinal hemorrhage was considered. Apatinib was withdrawn. He was given pressurized by intravenous infusion of suspended red blood cells, IV infusions of carbazochrome sodium sulfonate and glucose gluconate. The next morning, he experienced bloody stool 2 500 ml and vomited coffee-ground-like gastric content about 500 ml. He received oral lyophilized thrombin powder, pressurized by intravenous infusion of suspended red blood cells, IV infusions of dopamine hydrochloride and human albumin, intramuscular injection of vitamin K1, IV infusion of lansoprazole, etamsylate, aminome-thylbenzoic acid, pantoprazole sodium and fat emulsion amino acids (17) and glucose (11%). At the noon of the same day, he experienced melena about 80 g. He was given oral lyophilized thrombin powder. On day 2 after apatinib withdrawal, he experienced melena 30 g. On day 4, laboratory tests revealed the following levels again: RBC 2.6×1012/L, Hb 95 g/L, thrombin time 14 s, prothrombin time 16 s, D-dimer 1.9 mg/L, calcium 2.35 mmol/L, potassium 4.0 mmol/L, total protein 52 g/L, albumin 32 g/L, creatinine 28 μmol/L, uric acid 191 μmol/L. Nutrition supportive, liver and stomach protecting treatments continued, gastrointestinal hemorrhage did not recur.
  • 安全信息
    . 2014, 16(5): 293-1.
  • Li Nan, Gao Xin, Mao Yi, Hua Lu
    Adverse Drug Reactions Journal. 2018, 20(4): 266-271. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.04.005
    ObjectiveTo analyze the situation of bleeding in patients during oral warfarin treatment in an anticoagulant clinic.MethodsThe medical record data of patients who received warfarin treatment in Anticoagulant Clinic of Fuwai Hospital, Chinese Academy of Medical Sciences from May 1st, 2016 to April 30th, 2017 were collected from the hospital outpatient information system and analyzed retrospectively. According to age, the patients were divided into the youth group (<45-year-old), middle age group (45-65-year-old), and older age group (>65-year-old). According to indications of anticoagulation therapy, the patients were divided into the postoperative group of valve replacement (postoperative group), the atrial fibrillation/atrial flutter group, and the thromboembolic disease group. The situation of bleeding events during warfarin treatments in patients in the different age groups and the different indication groups were compared.ResultsA total of 915 patients were enrolled into the study, including 468 males and 447 females with ages from 14 to 89 years and an average age of (58±14) years. The youth group, the middle age group, and the older age group comprised 127, 482, and 306 patients, respectively. The postoperative group, the atrial fibrillation/atrial flutter group, and the thromboembolic disease group comprised 574, 271, and 70 patients, respectively. The number of patients whose warfarin dosage were ≤5 mg/d or 5-9 mg/d was 847 or 69, respectively. There were more patients with valve replacement in the youth and the middle age groups[87.40% (111/127), 73.86% (356/482)] and more patients with atrial fibrillation/ atrial flutter in the older age group[55.88% (171/306)]. Of the 915 patients, 87 developed bleeding events during warfarin treatment, which were evaluated to be induced by warfarin and the incidence of bleeding was 9.51%. Seven of the 87 patients were with severe bleeding and the incidence was 0.77%. The incidence of bleeding in the older age group was significantly higher than that in the middle age group[15.03% (46/306) vs. 7.05% (34/482), P<0.001] and the youth group[15.03% (46/306) vs. 5.51% (7/127), P=0.006]. The incidence of bleeding in the atrial fibrillation/atrial flutter group was significantly higher than that in the postoperative group[14.76% (40/271) vs. 6.62% (38/574), P<0.001]. The incidence of bleeding in the thromboembolic disease group was 12.86% (9/70). The differences of incidences of bleeding between the thromboembolic disease group and above-mentioned 2 groups were not statistically significant (all P>0.05). Of the 87 patients with bleeding, 75 (86.21%) were with single time bleeding, 71 (81.61%) were with single site bleeding, 80 (91.85%) were with slight bleeding; warfarin dosages in 82 (94.25%) patients were ≤5 mg/d, international normalized ratios (INR) in 77 (88.51%) patients were ≤3.00. Twelve (13.79%) patients received combined use of other drugs during warfarin treatment. A total of 113 times of bleeding events occurred in 87 patients, including 31 times of skin mucosal hemorrhage, 19 times of gingival bleeding, 13 times of hemorrhinia hemorrhage and ocular hemorrhage, 10 times of hemoptysis, 7 times of fecal occult blood and/or hemorrhoidal bleeding, 6 times of hemorrhage of digestive tract and urine occult blood, 5 times of gross hematuria, 1 time of menstrual extension, colporrhagia, and intracranial hemorrhage.ConclusionsThe incidence of bleeding in outpatients during warfarin treatment in Anticoagulant Clinic in Fuwai Hospital is 9.51%. The bleeding mainly occurred in elders and patients with auricular fibrillation or atrial flutter. The bleeding in most patients is mild.
  • ADR咨询
    . 2005, 7(5): 395-395.
  • 病例报告
    Li Chunlianga;Pan Qib;Guo Lixinb;Ji Liweic
    . 2010, 12(4): 289-2.
    A 56yearold woman with diabetes mellitus received human regular insulin about 3 years before hospitalization, and 15 minutes affter injection, the patient developed subcutaneous nodules at injection site with pruritus, which subside spontaneously in 1-4 days, and paroxysaml nocturnal dry cough. Six months before hospitalization, the regimen was instead of human isophane insulin and subcutaneous nodules remained, but dry cough at night disappeared. After admission, laboratory tests revealed eosinophils count of 062×109/L and the rate of eosinophils was 0.69. A IgE level was 96.60 U/mL and IAA examination was positive. On admission, she presented with asthma and the symptoms improved after treatments. The skin testing was performed in order to select an appropriate insulin preparation. Human isophane insulin 10 U once was selected based on the skin testing and acarbose, metformin, and pioglitazone were given. The patient had a well control of blood glucose and developed intermittent small scleroma which was subsided spontaneously, occasional pruritus, and dry cough and asthma did not recur.
  • 安全信息
    . 2012, 14(2): 76-1.
  • 网络医药
    . 2004, 6(3): 208-212.
  • 不良事件
    . 2006, 8(2): 87-87.
  • SARS防治
    . 2003, 5(3): 146-146.
  • Wang Xingdong, Yao Can, Li Boxia, Wang Rongzhen, Wei Yuhui
    Adverse Drug Reactions Journal. 2024, 26(8): 499-501. https://doi.org/10.3760/cma.j.cn114015-20240508-00312
    A 59-year-old female patient with lung cancer developed chest tightness, shortness of breath, fatigue, and oliguria after 2 cycles of anlotinib standard regimen. Laboratory tests showed serum creatinine 995.5?μmol/L, urea nitrogen 18.9 mmol/L, blood uric acid 637 μmol/L, 24 hour urine output 400 ml, blood potassium 3.63 mmol/L, alanine aminotransferase (ALT) 957 U/L, aspartate aminotransferase(AST) 32 U/L, total bilirubin 38.8 μmol/L, and platelet count 49×109/L. Acute renal failure, liver dysfunction, and thrombocytopenia was diagnosed. The auxiliary examination results excluded the possible progression of underlying diseases. The clinical manifestations of the patient were time?dependent with oral administration of anlotinib. Anlotinib was discontinued and symptomatic treatments such as hemodialysis, liver protection, and diuresis were given. After 14 days, chest tightness, shortness of breath, and fatigue were significantly relieved. Laboratory tests showed serum creatinine 480.3 μmol/L, urea nitrogen 16.2 mmol/L, blood uric acid 414 μmol/L, 24 hour urine output 1 700 ml, blood potassium 3.18 mmol/L, ALT 45 U/L, AST 31 U/L, total bilirubin 37.4 μmol/L, and platelet count 81×109/L.

  • Chen Tingting, Li You, Zhang Qingquan, Lin Zhiqiang
    Adverse Drug Reactions Journal. 2024, 26(7): 437-439. https://doi.org/10.3760/cma.j.cn114015‑20231129‑00846
    A 27‑year‑old female patient with AIDS received tenofovir alafenamide lamivudineand efavirenz(ART scheme). Because of the combined infection of talaromyces marneffei, she was givenintravenous infusion of voriconazole 200 mg once per 12 hours. On the 4th day of medication, the valleyblood concentration of voriconazole was 0.1 mg/L. The clinical pharmacist participated in the consultationand found that there was a drug interaction between efavirenz and voriconazole. The pharmacistrecommended to discontinue efavirenz and switch to dolutegravir. After discontinuing efavirenz, the patientmeasured the blood trough concentration of voriconazole multiple times and adjusted the dose ofvoriconazole multiple times. Within 14 days of efavirenz discontinuation, the blood trough concentration ofvoriconazole changed slowly(0.1-0.4 mg/L), and after 14 days, the blood trough concentration remainedbasically stable. After increasing the dose of voriconazole to 300 mg once every 12 hours orally, the bloodtrough concentration of voriconazole increased to 1.8 mg/L, which was within the reference value range. Thiscase suggests that when voriconazole is used in combination with efavirenz, even after discontinuingefavirenz, the metabolic induction effect of efavirenz still exists. Therefore, it is necessary to empiricallyincrease the dose of voriconazole and dynamically adjust it based on therapeutic drug monitoring results.
  • Li Ning, Zhai Jinghui, Chen Weiqiang, Wang Jie, Wang Yuanyuan, Liu Yanxue, Song Yanqing
    Adverse Drug Reactions Journal. 2024, 26(2): 118-120. https://doi.org/10.3760/cma.j.cn114015-20221212-01145
    A 67-year-old male patient with primary liver cancer was given combination treatment with regorafenib and sintilimab because of disease progression after multiple interventional therapy. After one cycle of medication, the patient developed weakness in the left facial expression muscle and left upper eyelid, and generalized muscle pain with dyspnea. Laboratory tests showed myoglobin 8-614-μg/L, creatine kinase (CK) 17-480-U/L, CK-MB mass 528-μg/L, troponin I 0.465-μg/L, aspartate aminotransferase (AST) 1-069-U/L, alanine aminotransferase (ALT) 493-U/L, and lactate dehydrogenase (LDH) 2-469-U/L. The electrocardiogram showed the new onset of left bundle branch block. It was considered to be immune-related myositis, immune-related myalgia, and immune-related hepatitis caused by sintilimab, not excluding immune-related cardiac toxicity. Regorafenib and sintilimab were discontinued immediately while methylprednisolone pulse therapy was initiated at a dose of 500-mg (gradually reduced after 5 days), monoammonium glycyrrhizinate and cysteine and sodium chloride injection and bicyclol were administered for liver protection and reducing liver enzyme levels. After 7 days of treatments, weakness in the left facial expression muscle and eyelid were improved significantly along with relief from chest tightness and alleviation of generalized muscle pain throughout the body. After 15 days of treatments, laboratory tests showed myoglobin 494-μg/L, CK 537-U/L, CK-MB mass 115-μg/L, AST 52-U/L, ALT 77-U/L, and LDH 519-U/L. After half a year of treatments, glucocorticoids therapy was discontinued, and all indicators returned basically to normal. The patient did not receive immunotherapy again.
  • 国外文献题录
    . 2001, 3(3): 209-210.
  • ADE简报
    . 1999, 1(3): 191-191.
  • 不良事件
    . 2003, 5(1): 66-66.
  • 不良事件
    . 2003, 5(1): 58-58.
  • 不良事件
    . 2005, 7(1): 66-66.
  • 不良事件
    . 2002, 4(6): 414-414.
  • 安全用药
    LI Lin-yan;XU Jian
    . 2012, 14(4): 228-4.

    Benzodiazepines are mainly used to treat anxiety and insomnia. Prolonged use of benzodiazepines can lead to physical and psychological dependence. The mechanism of benzodiazepine dependence is related to central neurotransmitters such as γ-aminobutyric acid and glutamate acid. The risk factors for benzodiazepine dependence include drug selection, drug administration, and individual difference. The clinical manifestations of benzodiazepine dependence are increased tolerance to the drug, withdrawal symptoms, and psychological dependence. The treatment strategies for benzodiazepine dependence include the drug withdrawal, adjuvant treatment with drug, substitutive treatment, combined therapy of Chinese and western medicine, and psychotherapy.

  • 安全信息
    . 2013, 15(1): 37-1.
  • 安全信息
    . 2010, 12(4): 300-1.
  • 不良事件
    . 2004, 6(1): 59-59.
  • ADR系列问答
    . 2007, 9(2): 152-152.
  • 安全信息
    . 2009, 11(5): 377-1.
  • 法规准则
    . 2007, 9(6): 420-423.
  • Cai Haodong, Wang Yuqin, Li Yuzhen
    Vaccination is one of the most successful public health achievements of human history. However, like any drug, no vaccine is absolutely safe. As the incidence of vaccine-preventable diseases has been effectively controlled by vaccines, the safety of vaccines inoculated in healthy people has attracted more and more attention. The United States is the earliest country to start vaccine safety management. After some major vaccine safety incidents, vaccine safety management has gradually developed and improved. Vaccine safety regulator in the United States mainly consists of 4 federal agencies: the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Health Resources & Services Administration (HRSA). FDA is mainly responsible for pre-market registration and approval of vaccines, and supervision and inspection of vaccine manufacturers. CDC is mainly responsible for making immunization planning, monitoring of vaccine adverse reactions, and management of free vaccine projects of government. NIH is mainly responsible for vaccine research and development. HRSA is mainly responsible for vaccine accident compensation. In addition, the experience of European Medicines Agency in limitation of validity period of vaccine license and vaccine quality management and the experiences in safety management of vaccines in Canada, Britain, Australia and New Zealand, including "cold chain" management, surveillance of vaccine adverse events, etc. are worthy of learning.
  • Wang Haifei,Sun Guoping
    . 2017, 19(6): 475.
    A 61-year-old female patient received an IV infusion of Xuesaitong  for injection 400 mg once daily for 6 days after the resection of left popliteal cyst. The next day after the drug withdrawal, She developed systemic rashes with itching and IV infusion of dexamethasone 10 mg once daily and oral chlorpheniramine 4 mg thrice daily were given. The symptoms were not improved after 7 days of treatments. On day 8, dexamethasone and chlorpheniramine were stopped, IV infusion of methylprednisolone 55 mg once daily and oral levocetirizine, cimetidine, potassium chloride sustained-release tablets were given. On day 10,the patient developed new eruption on the back, diffuse edematous erythema on the trunk and limbs, with light yellow pustules on erythema and part of pustules merging into sheet. According to the result of histopathological examination on the rash of the abdomen skin, acute generalized exanthematous pustulosis was considered. After that, the patient′s condition was improved, glucocorticoids was used continuously and the dosage was reduced gradually, while stomach-protective drugs and external use of skin treatment were given at the same time. On day 18, the dose of intravenous infusion of methylprednisolone was reduced to 20 mg once daily and oral methylprednisolone 12 mg once daily was given. On day 32, oral methylprednisolone was stopped. On day 37, new eruption appeared on the patient′s back, intramuscular injection of compound betamethasone injection 1 mg was given at one time, oral compound glycyrrhizin 80 mg and tripterygium glycosides 20 mg were given thrice daily. On day 50, the skin rashes darkened, pustules disappeared basically, no edema and new rash appeared. Methylprednisolone sodium succinate was stopped and changed to oral methylprednisolone tablets 20 mg once daily. Oral methylprednisolone was gradually reduced to 2 mg once daily and about 4.5 months later, the rashes subsided completely, methylprednisolone was stopped.
  • Yang Li, Ren Hao
    . 2015, 17(2): 157-158.
    A 61-year-old woman with uremia received hemodialysis therapy with heparin (integral dose 28 mg/time) for anticoagulation three times a week. She developed gum bleeding when brushed teeth after the sixth dialysis. Laboratory test showed the following results: platelet count (PLT) 22.0×109/L, D-Dimer 1 023 μg/L. Heparin was discontinued and changed to hemodialysis without heparin. The PLT increased to 88×109/L and D-Dimer decreased to 574 μg/L after hemodialysis without heparin twice. The PLT decreased to 50×109/L, and the D-Dimer increased to 1 012 μg/L after trying to use hemodialysis therapy with  low dose heparin (integral dose 14 mg/time) three times later. The patient received hemodialysis without heparin once again, the PLT increased to 95×109/L, and the D-Dimer decreased to 585 μg/L three times later. Then the patient received low molecular heparin for three times, the PLT decreased to 65×109/L, the D-Dimer increased to 1 386 μg/L. The hemodialysis was stopped and therefore switched to peritoneal dialysis. After that, the results of rechecks showed the following results: the PLT (126-208) ×109/L, the D-Dimer 287-293 μg/L.
  • Li Maosheng, Wu Zhimei
    . 2017, 19(2): 130-131.
    A 32-year-old female patient with schizophrenia received amisulpride 0.8g twice daily. The results of her routine blood test were normal before taking medicine. On day 26 of administration, the results of routine blood test showed white blood cell count (WBC) 2.3×109/L,  neutrophil count (NEUT) 1.4×109/L. She was given batilol tablet 100 mg and leucogen tablet 20 mg three times daily. On day 32 of administration, the results of routine blood test showed WBC 3.7×109/L,NEUT 2.2×109/L, platelet count (PLT) 65×109/L. The patient received hypodermic injection of recombinant human interleukin-11 for injection 1.50 mg once daily for 7 days. The result of reexamination 7 days later showed WBC 3.9×109/L,NEUT 2.5×109/L,and PLT 113×109/L. She needed to take amisulpride sequentially for treatment. On day 51 of administration, she developed weak, dizziness and headache occasionally. The result of laboratary test showed WBC 2.7×109/L, NEUT 1.4×109/L. The dosage of amisulpride was decreased gradually and then withdrawn. She was given olanzapine 20 mg daily. The result of reexamination on day 18 and 33 of drug withdrawal showed WBC 4.1×109/L, NEUT 2.4×109/L, PLT 100×109/L and WBC 4.2×109/L, NEUT 2.4×109/L, PLT 110×109/L, respectively.
  • Yang Xiangjun, Zhu Liqin
    . 2016, 18(6): 462.
    A 60-year-old female patient with bronchiectasis and pulmonary infection received IV infusion of imipenem and cilastatin sodium 1 g thrice daily and doxofylline 0.2 g once daily, IV injection of ambroxol 30 mg thrice daily, and myrtol standardized enteric capsules 300 mg thrice daily by mouth. On the 6th day after treatments, the patient′s cough and expectoration were improved and wheezing disappeared. However, she developed nausea, vomiting, and dizziness with no other apparent precipitating causes. Intramuscular injection of metoclopramide 10 mg was given and the gastrointestinal symptoms were improved, while the dizziness was not improved. Then betahistine mesylate 6 mg thrice daily was given. One hour after taking the first betahistine mesylate, the patient developed dyspnea and feeling of asphyxia, dry and wet rales in her bilateral lungs, and wheezing rales. Isosorbide mononitrate was given by sublingual administration and her symptoms were not mitigated. It was considered that betahistine mesylate induced the bronchial spasm. Betahistine mesylate was stopped and loratadine 10 mg was given once daily by mouth. The next day, the patient′s dyspnea relieved, dry and wet rales reduced in her bilateral lungs, and wheezing rales disappeared. After 20 days of treatments, the patient was discharged and bronchial spasm did not recur.
  • Bai Yuqing, Liu Min, Yi Wei, Hu Yuhong, Zhou Mingfang, Liu Jun, Cai Haodong
    . 2017, 19(5): 330.
    ObjectiveTo explore the effect of interruption of nucleos(t)ide analogues before pregnancy in women with chronic hepatitis B on the pregnancy outcome.MethodsThe medical records of pregnant patients in Beijing Ditan Hospital, Capital Medical University from November 1st, 2008 to November 30th, 2016 were analyzed retrospectively. These patients had chronic hepatitis B and accepted anti-hepatitis B virus (HBV) treatment with nucleos(t)ide analogues before pregnancy. They were divided into the obser-vation group and the control group. In the observation group anti-HBV treatment was interrupted for 1 month at least before pregnancy. The control group maintained anti-HBV treatment with telbivudine till pregnancy occurred. Two groups of patients with liver disease progression, pregnant complication, fetal results, and adverse drug reactions were analyzed.ResultsA total of 265 patients were enrolled into the analysis. There were 94 cases in observation group aged from 21 to 45 years with average age of (29±4) years. There were 171 cases in control group aged from 20 to 43 years with average age of (31±4) years. The proportions of HBeAg positive,  elevated alanine aminotransferase level and the proportion of cases with HBV DNA>1×105 IU/ml and median level of alanine aminotransferase in the observation group in the first pregnancy examination were significantly higher than those of the control group [81.9% (77/94) vs. 70.2%(120/171), P=0.036; 40.4% (38/94) vs. 9.4% (16/171), P<0.001; 83.0% (78/94) vs. 3.5% (6/171), P<0.001; 78 U/L vs. 15 U/L, P<0.001]. Twenty-six cases in the observation group had liver disease progression and 25 cases were hospitalized, and one case had liver failure which led to death of the neonate because of preterm birth, one case developed liver cancer. Sixty cases were treated again with lamivudine or telbivudine at 12-33 weeks of gestation. In the control group, only one case was hospitalized for aggravation of the liver disease caused by telbivudine resistance, and recovered after treatment with tenofovir. The difference in adverse pregnant complications including gestational diabetes mellitus, intrahepatic cholestasis of pregnancy, moderate and severe anemia and pregnancy induced hypertension in both groups were not statistically significant (all P>0.05). Gestational age of newborns in the observation group was different from that of the control group [(38.4±1.7) weeks vs. (38.8±1.2) weeks, t=2.352, P=0.019]. The proportion of birth defects, birth weight, the proportion of preterm infants or low birth weight infants in both groups were not significantly different (all P>0.05). One case in every group had adverse reaction related to telbivudine, they were elevated level of creatine kinase and peripheral neuropathy, respectively.ConclusionsPatients with chronic hepatitis B had the risk of hepatitis B progression once they interrupted anti-HBV treatment before meeting the criteria for termination of the treatment. No evidence showed that telbivudine or lamivudine caused relevant adverse pregnant complication or inborn abnormality of infants during pregnancy.
  • 病例报告
    Wang Rui;Tang Yanping;Gong Yanxia;Jia Jiannan
    . 2011, 13(6): 382-2.
    Two female patients, aged 67 and 34 years (patient 1 and patient 2), respectively, received loratadine 10 mg once daily for skin rashes. They developed yellowish skin and sclera, dark urine, and anorexia on days 6 and 7, respectively. Laboratory tests showed the following values: total bilirubin (TBil) 204.3 μmol/L, direct bilirubin (DBil) 108.24 μmol/L, indirect bilirubin (IBil) 96.06 μmol/L, alanine transaminase (ALT) 917 U/L, aspartate transaminase (AST) 904 U/L in patient 1; and TBil 85.3 μmol/L, DBil 44.80 μmol/L, IBil 40.50 μmol/L, ALT 1565 U/L in patient 2. Both patients received liver-protective treatments and medications used to treat jaundice. Their symptoms subsided gradually and hepatic function normalized on days 40 and 14 of treatment, respectively.
  • 病例报告
    CHEN Wen-ju;HE Hui-jiang;SONG Jin-sen;LI Hao
    . 2012, 14(4): 253-2.
    A 54-year-old female self-administered imatinib mesylate 400 mg once daily for postoperative liver metastasis from small intestinal stromal tumor operation. After taking the drug for 45 days, the patient developed palpitation, severe systemic edema and rash. The symptoms did not improved after the dose reduction and then she was hospitalized. Physical examination revealed that her heart rate was 78 beats/min and chapped skin with fluid exudation occurred on her hands and feet. She also developed conjunctival congestion and edema, and severe systemic edema. Laboratory tests showed the following levels and values: eosinophil count 0.74×109/L, red blood cell count 3.44×1012/L, blood glucose 6.67 mmol/L, alanine aminotransferase 42 U/L. Imatinib mesylate was stopped immediately, hydrochlorothiazide 10 mg thrice daily and propafenone 100 mg thrice daily were given orally. The patient’s palpitation and edema symptoms gradually improved. On day 4, the patient’s skin developed hyperkereratosis, rough, and partial desquamation. On day 7, large areas of skin desquamation occurred. Thirty days later, her skin gradually returned to normal.
  • 述评
    . 2013, 15(1): 2-2.
  • 病例报告
    WANG Si-ping
    . 2012, 14(2): 116-2.
    A 20-year-old man with osteosarcoma received two cycles of chemotherapy treatment with high-dose methotrexate (8 g/m2). On day 7 after the second cycle of chemotherapy, the patient suddenly experienced dysphasia, accompanied by numbness of left hand, nausea, asthenia, and gradually developed aphasia, stiffness in both upper limbs and numbness in both lower limbs. Laboratory tests showed the following values: WBC count 12.5×109/L, RBC count 3.6×1012/L, hemoglobin 111 g/L, and platelet count 101×109/L. A cranial CT scan revealed no abnormal findings. He was treated with oxygen inhalation. His condition improved after three hours. Similar symptoms recurred in the absence of other causative factors in the next afternoon. Brain magnetic resonance imaging, diffusion-weighted imaging, electroencephalogram, ultrasonic cardiogram and carotid ultrasound imaging showed normal findings. An IV infusion of cinepazide maleate and citicoline was given. Two days later, his symptoms disappeared.
  • 不良事件
    . 2005, 7(3): 230-230.
  • 不良事件
    . 2003, 5(5): 347-347.
  • ADR护理
    . 2002, 4(5): 322-323.
  • 不良事件
    . 2005, 7(4): 309-309.
  • 国外文献题录
    . 2001, 3(2): 131-132.
  • 不良事件
    . 2004, 6(4): 262-262.
  • 监测简报
    . 2003, 5(3): 197-197.
  • 个案分析
    . 2002, 4(1): 51-52.
  • ADE简报
    . 2001, 3(1): 54-54.
  • 不良事件
    . 2003, 5(4): 271-271.
  • Fang Hao, Zhang Li
    Adverse Drug Reactions Journal. 2023, 25(7): 437-438. https://doi.org/10.3760/cma.j.cn114015-20220802-00703
    A 57-year-old male patient with type 2 diabetes mellitus was treated with alogliptin benzoate 25-mg once daily orally. His liver function was normal before the treatment. The patient developed yellowish skin and fatigue after 25 days of treatment. Laboratory tests showed total bilirubin (TBil) 65-μmol/L, alanine aminotransferase (ALT) 2-856-U/L, aspartate aminotransferase (AST) 1-028-U/L, and alkaline phosphatase (ALP) 124-U/L. After excluding viral hepatitis, autoimmune liver disease, and obstructive jaundice, liver injury caused by alogliptin benzoate was considered. The drug was stopped and liver protective treatments were given. Seventeen days later, the patient′s symptoms disappeared, and laboratory tests showed TBil 17-μmol/L, ALT 112-U/L, AST 30-U/L, and ALP 76-U/L.
  • Xu Baoping, Yang Hao, Wei Qiguo, Peng Huaiwen
    Adverse Drug Reactions Journal. 2023, 25(1): 55-57. https://doi.org/10.3760/cma.j.cn114015-20220406-00286
    A 35-year-old female patient with diabetes ketoacidosis received insulin, meropenem, ganciclovir, correction of acidosis, and fluid infusion due to pulmonary infection. Because sputum culture results suggested aspergillus infection, ganciclovir was stopped and replaced by caspofungin; because the patient′s peak temperature dropped, meropenem was stopped and replaced by piperacillin sodium and tazobactam sodium. Before antibacterial treatments, the blood potassium and calcium were 3.7-mmol/L and 2.07-mmol/L, respectively, and the blood potassium and calcium were 3.5 and 2.18-mmol/L, 3.0 and 1.89-mmol/L, 2.6 and 1.96-mmol/L, and 3.0 and 1.97-mmol/L, respectively on the 3rd, 6th, 8th, and 10th days after using caspofungin and on the 2nd, 3rd, 7th, and 9th days of treatment with piperacillin sodium tazobactam sodium. Piperacillin sodium tazobactam sodium was stopped, caspofungin, potassium and calcium supplements, and other symptomatic treatments were continued. Two days later, blood potassium was 3.0-mmol/L and blood calcium was 1.96-mmol/L. Then caspofungin was stopped and replaced by voriconazole. Three days later, the blood potassium was 3.8-mmol/L and the blood calcium was 2.12-mmol/L. It was considered that the hypokalemia and hypocalcemia were possibly induced by caspofungin.
  • 不良事件
    . 2003, 5(2): 126-126.
  • ADE简报
    . 2001, 3(1): 52-52.
  • ADR术语
    . 2003, 5(4): 279-281.
  • 病例报告
    . 2003, 5(3): 193-194.
  • ADE简报
    . 2001, 3(3): 202-202.
  • 不良事件
    . 2003, 5(3): 201-201.
  • 监测简报
    . 2003, 5(5): 343-343.
  • 病例报告
    DENG Ti-ying
    . 2012, 14(6): 375-2.

    An 89-year-old female patient received an IV infusion of clindamycin 1.35 g dissolved in 0.9% sodium chloride 250 ml once daily for bronchitis. Ten minutes after infusion started, drug extravasation occurred and the dorsum of hand of the patient became swollen. The needle was pulled out immediately and her lesion was treated with applying compound sodium aescinate gel and receiving wet dressing with magnesium sulfate. The next day, she presented with a blister of 2 cm in diameter at the infusion site and then the blister ruptured. Skin ulceration and necrosis occurred and progressed to black crusts. Dressing change and other treatment were given and, about one month later, her skin ulceration gradually healed.

  • 病例报告
    HU Xiao-lei;LIU Rui;WANG Yu;HE Ju-ying
    . 2012, 14(5): 304-2.
    An 82-year-old woman received risedronate sodium 5 mg once daily for severe osteoporosis. On day 2, she developed diffuse red erythema involving her entire body with pruritus and partial confluent plaques. On day 4, some blisters ruptured along with purulent secretions on her partial skin. Risedronate sodium was stopped immediately, and an IV infusion of dexamethasone and an IV infusion of hydrocortisone sodium succinate were given; levocetirizine hydrochloride and ketotifen fumarate were given by mouth; zinc oxide lotion was given for external application; and at the same time, symptomatic treatments, such as acid suppression, potassium supplement, were given. After 12 days of treatment, the patient’s rash on her entire body gradually subsided.
  • 病例报告
    Liu Lifang;Wei Xuan
    . 2011, 13(6): 386-2.
    A 59-year-old female patient received IV gadobenate dimeglumine 15 ml for enhanced MRI scan. Ten seconds later, the patient experienced irritating cough, tingling in her left arm, and facial swelling. After 10 minutes, she developed dizziness, blurred vision, palpitation, chest distress and her symptoms continued to worsen. Her blood pressure decreased to 70/40 mm Hg. Gadobenate dimeglumine-induced anaphylactic shock was considered. The patient was given dexamethasone, hydrocortisone, calcium gluconate, promethazine, dopamine, norepinephrine, and a rapid fluid infusion. After an hour, the above-mentioned symptoms relieved and, after 24 hours, her blood pressure was 120/60 mmHg and her heart rate was 92 beats/min.
  • 病例报告
    Wu Yuntao;Chen Yanmei;Cao Jingjing;Bai Xupeng;Lü Mingfang
    . 2010, 12(4): 280-2.
    A 77yearold male patient received a slowly IV push of ibutilide 1 mg dissolved in 50 mL of 0.9% sodium chloride for his atrial fibrillation(AF) conversion. After sixteen minutes, AF was converted to sinus rhythm. But he experienced 10 episodes of sinus arrest with the longest R-R interval of 4.872 seconds. The patient did not have dizziness, headache, chest pain, chest discomfort. After AF was successfully converted, the patient continued to take propafenone, metoprol, warfarin without any discomforts.
  • 病例报告
    Liu Xiaodong;Sun Hao;Liu Limin;Zhao Limei
    . 2011, 13(1): 50-1.
    A 44yearold man received cefotiam, compound mannitol, followed by an IV infusion of oxiracetam 4.0 g dissolved in 5% glucose 250 ml after undergoing surgery for intraspinal neurilemma. About 15 minutes after oxiracetam infusion start, the patient experienced convulsion, diaphoresis accompanied by facial and peripheral cyanosis. Oxiracetam was discontinued and he was given mask oxygen. ECG monitoring revealed a blood pressure of 90/60 mm Hg and a heart rate of 120 beats/min. Adrenaline 1 mg was given by IV push, and then a rapid IV infusion of 0.9% sodium chloride injection 500 ml was administered. Ten minutes later, his blood pressure decreased to 80/50 mm Hg and his oxygen saturation was 0.90. He received an IV push of adrenaline 1 mg and dexamethasone 5 mg again. Twenty minutes later, the patient’s convulsions disappeared and his blood pressure increased to 100/75 mm Hg.
  • Liu Jia, Zhang Jing
    . 2017, 19(5): 359.
    ObjectiveTo compare the efficacy and safety between two antiplatelet therapies in patients with acute coronary syndromes (ACS) after percutaneous coronary intervention (PCI) and 1 year dual antiplatelet therapy (DAPT).MethodsThe medical records of patient with ACS who underwent PCI and received DAPT for 1 year in Northern Jiangsu People′s Hospital from January 1, 2015 to December 31, 2015 were collected. The patients′ sex, age, primary cardiovascular disease, coexisting diseases, past PCI history, smoking status, and the status of combination of proton pump inhibitors and statins were recorded. The patients were divided into DAPT group (aspirin 100 mg once daily plus clopidogrel 75 mg once daily or ticagrelor 90 mg twice daily, orally ) and aspirin group (aspirin 100 mg once daily, orally) according to the different subsequent antiplatelet therapies. The two therapies were persisted for 6 months. The patients were followed up by telephone or subsequent visit. The occurrences of cardiovascular events and the bleeding events in 2 groups were compared by log-rank test.ResultsThe number of patients in DAPT group and Aspirin group were 75 and 71, respectively. There were no significant differences in gender, age, ACS type distribution, past PCI histories, proportions of smoker and combined use of proton pump inhibitors and statins between the 2 groups (all P>0.05). The proportions of patients complicated with diabetes and hypertension in the DAPT group were higher than those in the aspirin group (all P<0.05). There was 1 patient who stopped clopidogrel and 2 patients lost to follow up in the DAPT group, the follow-up rate was 96.0% (72/75).  Two patients in in the aspirin group were lost to follow up, the follow-up rate was 97.2% (69/71). At the end of follow-up, the cumulative incidence rates of cardiovascular events and severe cardiovascular events in the DAPT group were 27.8% (20/72) and 9.7% (7/72), and 27.5% (19/69) and 13.0% (9/69) in the aspirin group, respectively. The cumulative incidence rates of bleeding events and severe bleeding events in the DAPT group were 22.2%(16/72) and 11.1%(8/72), and 26.1%(18/69) and 4.3%(3/69) in the aspirin group, respectively. None of the differences were statistically significant (all P>0.05).ConclusionsThe results of prolonging DAPT course in patients with ACS who underwent PCI and had no severe cardiovascular events and bleeding events during the period of 1 year′s DAPT showed that there were no significant decrease in incidence rate of cardiovascular event, and no increase in risk of bleeding. Aspirin may be recommended to be used for the continuous antiplatelet therapy.
  • Cao Kai;Sun Min;Li Jing;Si Jigang
    . 2015, 17(1): 69-2.
    A 57-year-old woman with breast cancer received combined chemotherapy of epirubicin (an IV infusion of 50 mg on day 1 and day 2) and docetaxel (an IV infusion of 100 mg on day 1). Her myelogram was normal before chemotherapy. On day 11 of the first period of chemotherapy, she developed fever, hypodynamia, and watery stool. The blood routine examination showed white blood cell count (WBC) 1.7×109/L, red blood cell count (RBC) 3.2×1012/L, hemoglobin (Hb) 101 g/L, platelet count (PLT) 65×109/L. On day 13, the examination showed WBC 0.08×109/L, neutrophil count (NEUT) 0, RBC 3.3×1012/L, Hb 101 g/L, PLT 31×109/L. On day 14, WBC 0.1×109/L, NEUT 0, RBC 2.6×1012/L, Hb 89 g/L, PLT 7×109/L. The patient developed secondary severe pneumonia and acute respiratory distress syndrome. The symptomatic and supportive treatments including anti-infection and stimulating leukocytes production were given. However, the patient′s condition did not improve significantly. On day 14 of the first period of chemotherapy, the patient eventually died due to respiratory and circulatory failure.
  • 论著
    Luo Lingjuan;Xie Xinmei;He Wenting;Zeng Fanye;Zhang Hongliang
    . 2014, 16(3): 159-4.
    ObjectiveTo explore the mechanism of in myocardial damage due to daunorubicin (DNR) in rats.MethodsSD rats were divided into the control group and the DNR group using a random-digital table, each group comprised 15 rats. The rats in the DNR group received intraperitoneal injection of daunorubicin 3.5 mg/kg once a week for 4 weeks. The rats in the control group received intraperitoneal injection of same volume of 0.9% sodium chloride solution once a week for 4 weeks. The rats′behavior changes in the 2 groups were observed. The electrocardiographic examination, expression of sarcoplasmic reticulum Ca2+-ATP enzyme (SERCA2a) and histopathological test were performed at the end of 1, 3 and 4 weeks of the experiment on 5 rats in the 2 groups, respectively. ResultsThe subacute myocardial injury rat model could be reproduced by DNR intraperitoneal injection. The rats in the DNR group developed lassitude, drumble and drowsiness from the second week. The control group rats′activity, body weight and feeding were normal. The electrocardiographic examination in DNR group showed the following results: voltage of QRS wave decreased by more than 30% compared with the normal, ST segment elevation, and P wave peaked. Myocardial tissue histopathological examination revealed turbid cytoplasm, vacuolation, disordered arrangement of muscle fiber, and broadened fiber gaps. The expression of SERCA2a were moderately positive in both groups at the end of the first week. The expression of SERCA2a were weakly positive in the DNR group at the end of the third and fourth weeks. The number of SERCA2a positive cells in the DNR group at the end of the third and fourth weeks was significantly less than that in the control group at the same time points [(42.2±1.2) vs (65.30±1.6), (35.2±6.0) vs (66.7±1.5), all P<0.05].ConclusionDNR may inhibit the expression of SERCA2a in myocardial tissue and it may be one of the mechanisms of DNR′s myocardial toxicity.
  • Zhang Hanyu
    . 2016, 18(5): 371.
    A 48-year-old woman took 2 tablets of compound paracetamol tablet for headache. Her headache was relieved. She took 2 tables of compound paracetamol tablet again on the next day because of headache once again. Twenty minutes after drug administration, she developed dizziness, fatigue. Then scattered rash appeared on her face, neck and arms. Her blood pressure was 80/50 mmHg with heart rate 102 beats/min. The patient received a speedy IV infusion of hydroxyethyl starch 500 ml, intravenous injection of dexamethasone 10 mg and calcium gluconate 10 ml, and an IV infusion of vitamin C 3.0 g dissolved in 205 ml sodium chloride. Laboratory test showed slightly declined platelets, increased urea nitrogen, obviously increased levels of blood serum total bilirubin, direct bilirubin, alanine aminotrans-ferase, and aspartate transaminase, slightly increased troponin-T, troponin-I, and creatine kinase MB isoenzyme, obviously prolonged prothrombin time and activated partial thromboplastin time, and the markedly reduced prothrombin activity and fibrinogen. The patient was diagnosed as anaphylactic shock complicated with multiple organ dysfunction syndrome caused by compound paracetamol tablet. Compound paracetamol tablet was stopped. She received the symptomatic treatments of antianaphylaxis, protecting heart, liver and kidney. Fifteen days later, her erythra disappeared, liver and kidney function, myocardial enzymes, and  blood coagulation index returned to normal.
  • Mu Guangyan, Xiang Qian, Hu Kun, Cui Yimin
    A 55-year-old female patient with hyperlipemia received atorvastatin calcium tablets 20 mg, once daily orally. Two years later, the patient′s legs appeared ecchymosis with distending pain and numbness. Laboratory tests showed serum myoglobin 682 μg/L and creatine kinase 1 007 U/L. She had not received any other drugs during the same period. Atorvastatin-induced rhabdomyolysis was considered. Atorvastatin was stopped, and the patient received symptomatic and supportive treatment. Twenty days later, her symptoms disappeared and her serum myoglobin and creatine kinase level turned to normal. A gene test of SLCO1B1 C521T polymorphism of organic anion transporting polypeptides associated with statin-induced muscle injury was detected after rhabdomyolysis, and the result showed TT genotype (non-mutant genotype). This suggested that the SLCO1B1 C521T genotypes could not predict the myotoxicity of statins accurately.
  • Cai Haodong
    Adverse Drug Reactions Journal. 2018, 20(6): 480-480. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.028
  • Liu Zhijun
    Adverse Drug Reactions Journal. 2019, 21(6): 401-405. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.001
    With the gradual improvement of people′s awareness of medication safety, drug interaction has become a hot topic in the field of medicine. However, there are still some misunderstandings about drug interactions and incompatibility, drug interactions and adverse drug reactions (ADR), the incidence of drug interactions, the clinical significance of case reports, and how to scientifically judge the clinical significance of drug interactions. Drug interactions refer to the pharmacokinetic or pharmacodynamic interactions of 2 or more drugs within the body, involving in drug absorption, distribution, metabolism, excretion, pharmacodynamics, pharmacogenomics, and etc. Compatibility refers to the changes of physical and chemical properties of 2 or more drugs in the same premixed container during the in vitro mixing process, the existence of physical incompatibility or chemical instability. Physical incompatibility and/or chemical instability are collectively referred to as incompatibility. Adverse drug interactions are not ADR. In clinical practice, attention should be paid to drug interactions with clinical significance, and contraindicated drug combinations should be actively avoided. On the premise of careful monitoring, some drugs with clinical significant interactions could also be used together. Due to the different criteria for judging drug interactions with clinical significance, it is not possible to get a generally accepted incidence of drug interactions at present. Case reports on drug interactions are important risk signals. Independent case reports of the same group of drugs have more reference value, whic
  • Zhang Yuanyuan, Li Suxian, Li Zhihong
    Adverse Drug Reactions Journal. 2021, 23(3): 140-144. https://doi.org/10.3760/cma.j.cn114015-20200909-00943
    Selective serotonin reuptake inhibitors (SSRIs) are commonly used in treatment for patients with depression during pregnancy. However, none of the SSRIs is recommended for the treatment of depression during pregnancy. Using SSRIs during pregnancy may attribute to the risk of miscarriage and stillbirth, but there may be other confounding factors. Compared with other SSRIs, paroxetine and fluoxetine have higher risk of teratogenicity, and sertraline and citalopram have higher safety. In the third trimester of pregnancy, SSRIs may cause withdrawal symptoms in neonates and persistent pulmonary hypertension of the newborn (PPHN), of which sertraline has a lower risk of PPHN. The long-term effects of SSRIs on infants are still controversial. The formulation of medications for depression during pregnancy needs to weigh the pros and cons and the drugs should not be discontinued due to the potential risks. The risk of drug withdrawal may be higher than that of continuing to use the drug.
  • ZHANG Kang-huai;WANG Na;CAI Yan
    A 21-year-old male patient received Qubai Babuqi tablet 1.5 g thrice daily for vitiligo. Two months later, he developed jaundice of skin and sclera, and dark urine. Laboratory tests showed the following values: total bilirubin (TBil) 540.7 μmol/L, direct bilirubin (DBil) 365.3 μmol/L, alanine transaminase 390 U/L, aspartate transaminase 553 U/L, γ-glutamyl transferase (γ-GT) 102 U/L, alkaline phosphatase 208 U/L, and alpha-fetoprotein (AFP) 1147 μg/L. Qubai Babuqi tablet was stopped. He was given liver-protective drugs. Ten weeks later, repeat laboratory tests showed the following values: TBil 34.6 μmol/L, DBil 15.7 μmol/L,γ-GT 122 U/L, and AFP 9.4 μg/L.
  • ADR系列问答
    . 2007, 9(3): 228-228.
  • ADR咨询
    . 2000, 2(3): 210-210.
  • 国外文献题录
    . 2002, 4(6): 415-416.
  • 不良事件
    . 2004, 6(3): 197-197.
  • 中毒救治
    . 2005, 7(4): 277-278.
  • 不良事件
    . 2003, 5(3): 203-203.
  • ADE简报
    . 2000, 2(3): 199-199.
  • 病例报告
    . 2002, 4(5): 338-338.
  • 网络医药
    . 2004, 6(4): 278-282.
  • 不良事件
    . 2002, 4(3): 201-201.
  • Jin Meihua, Yang Xue, Hou Min, Li Yang, Zhang Pan, Xing Haiyan
    Adverse Drug Reactions Journal. 2023, 25(11): 690-694. https://doi.org/10.3760/cma.j.cn114015-20230512-00354
    The characteristics of adverse reactions caused by new antineoplastic agents are significantly different from those by traditional chemotherapy drugs, especially the immune-related adverse events caused by immune checkpoint inhibitors (ICIs), in which the diagnosis and treatment often involve multiple fields such as tumor, cardiovascular, endocrine, and immunity. In order to ensure the safety of new antineoplastic agents in the clinical application, the Pharmacy Department of Army Medical Center, Army Medical University established a specialized clinical pharmacy cooperation group of tumor-chronic diseases in October 2022, which is made up of clinical pharmacists majoring in tumor, immunity, cardiovascular, digestion, endocrine, respiration, and anti-infection, to provide pharmaceutical services for managing serious and perplexing adverse drug reaction in tumor patients. As of March 2023, 20 patients have been intervened by the cooperation group, and suggestions from the cooperation group in 17 patients have been adopted and achieved good results. About 98% of the clinicians and nurses are satisfied with the working mode of the cooperation group. This article takes a case of ICI-related myocarditis as an example to illustrate that through the cooperation group model we can provide multi-dimensional, efficient, and full process pharmaceutical care in the clinic, thereby significantly alleviating the problems of insufficient allocation of clinical pharmacists and inadequate coverage of pharmasits with different pharmaceutical specialties.
  • Ling Juan, Jiang Yan, Xie Zhuolin, Zhao Hongting, Luo Xiangxia
    Adverse Drug Reactions Journal. 2023, 25(12): 739-747. https://doi.org/10.3760/cma.j.cn114015-20230605-00406
    Objective To systematically evaluate the risks of gastrointestinal reactions induced by sodium-glucose transporter 2 (SGLT2) inhibitors in patients with type 2 diabetes mellitus. Methods Randomized controlled trials of SGLT2 inhibitors in the treatment of type 2 diabetes mellitus, in which gastrointestinal reactions were evaluated as one of outcome indicators, were collected by searching relevant databases at home and abroad (up to December 30, 2022). Cochrane risk of bias assessment tool was used to evaluate the quality of the included studies. Stata 15.1-software was used to conduct Bayesian network meta-analysis, including drawing the network evidence plot, the league map of pairwise comparison, and the surface under the cumulative ranking curve (SUCRA) for gastrointestinal reaction risks with different interventions of SGLT2 inhibitors, and ranking the risks of gastrointestinal reaction of different interventions of SGLT2 inhibitors. The effect sizes of gastrointestinal reaction were expressed by relative risk (RR) and its 95% confidence interval (CI). Results A total of 15-studies were included in the analysis, involving 5-540 patients with 3-949 in the SGLT2 inhibitor treatment group and 1-591 in the control group. Drugs that used in the treatment group included dapagliflozin (in 1-872 patients), canagliflozin (in 1-100 patients), empagliflozin (in 649 patients), ertugliflozin (in 219 patients), ipragliflozin (in 61 patients), and licogliflozin (in 48 patients). All patients in the control group were treated with placebo. The results of the network meta-analysis showed that the risk of gastrointestinal reactions was higher after treatment with 10-mg of ertugliflozin, compared with those with 50-mg and 100-mg of canagliflozin (RR=1.37, 95%CI: 1.02-3.48; RR=2.98, 95%CI: 1.19-4.09; all P<0.05). There was no statistically significant difference in comparison between other interventions with SGLT2 inhibitors. According to the results of SUCRA on the relative risks for gastrointestinal reactions of different interventions with SGLT2 inhibitors, interventions were ranked as licogliflozin 50-mg, ertugliflozin 25-mg, ertugliflozin 10-mg, empagliflozin 25-mg, ipragliflozin 100-mg, ipragliflozin 300-mg, ipragliflozin 200-mg, ertugliflozin 5-mg, licogliflozin 10-mg, ipragliflozin 50-mg, empagliflozin 10-mg, licogliflozin 2.5-mg, dapagliflozin 20-mg, dapagliflozin 10-mg, empagliflozin 5-mg, ertugliflozin 1-mg, dapagliflozin 5-mg, placebo, canagliflozin 300-mg, canagliflozin 200-mg, dapagliflozin 2.5-mg, dapagliflozin 1-mg, canagliflozin 100-mg, canagliflozin 50-mg. Conclusions Different SGLT2 inhibitor treatment regimens lead to different risks of gastrointestinal reactions in patients with type 2 diabetes. The risk of gastrointestinal reactions caused by canagliflozin is low, especially under the dose of 50-mg. Licogliflozin and ertugliflozin have greater possibility to cause gastrointestinal reactions, especially when they were used at high doses.
  • Li Yujie, Zhang Wenjing, Yang Hongxin, Guo Hao
    Adverse Drug Reactions Journal. 2024, 26(12): 726-731. https://doi.org/10.3760/cma.j.cn114015-20240419-00270
    Objective To analyze the clinical characteristics of periostitis induced by voriconazole. Methods The case reports of voriconazole-induced periostitis in PubMed, CNKI and other domestic and foreign databases were searched up to March 20, 2024. The patients′ gender, age, disease history, the indica- tions, usage and dosage of voriconazole, as well as the symptoms, examination results, clinical treatments and outcomes of periostitis were recorded. The severity of adverse reactions was graded according to the Common Adverse Event Evaluation Criteria (CTCAE) version 5.0. Descriptive statistical analysis was performed on the collected data. Results A total of 61 patients were included in the analysis, including 26 males and 35 females. Their age ranged from 5 months to 74 years, and 33 patients were more than 60 years. Fungal categories were described in 41 patients (including Aspergillus, Histoplasma, Candida, Fusarium, and Trichosporum asachii) and not described in 16 patients; indications of voriconazole were not reported in 4 patients. Forty-eight patients (78.7%) received the anti-infective therapy after transplantation. The time from application of voriconazole to occurrence of periostitis ranged from 12 days to 2 920 days, and the median time was 270 days after initial medication. The main symptoms of periostitis were reported in 53 patients and all of them had muscle and bone pain, including 13 cases of grade 3 pain (severe) and 10 cases of transplant recipients. Other concomitant symptoms included fatigue, muscle weakness or muscle atrophy, anorexia, and irritability. Laboratory test results were reported in 42 patients, 39 of which had increased alkaline phosphatase (ALP) and 7 had increased bone-specific alkaline phosphatase (BALP). Imaging findings were reported in 59 patients, all of which had specific manifestations such as multifocal periostitis, periosteal thickening, periosteum calcification or reactive new bone formation. After occurrence of periostitis, 50 patients were improved after voriconazole withdrawal and 1 patient was improved after reducing the dose; 2 patients only received analgesic treatment and the pain were slightly relieved; 5 patients died but not because of periostitis. Conclusions Periostitis induced by voriconazole is more common in patients after transplantation, with long incubation period and obvious pain, which can be accompanied by increased ALP or BALP levels. The symptoms could be relieved after drug withdrawal and analgesic treatments could be given in patients with severe pain.
  • 病例报告
    . 2002, 4(3): 197-197.
  • 病例报告
    . 2006, 8(4): 304-304.
  • 不良事件
    . 2005, 7(4): 310-310.
  • 不良事件
    . 2002, 4(3): 168-168.
  • 个案分析
    . 2001, 3(4): 262-263.
  • 不良事件
    . 2004, 6(2): 132-132.
  • 监测交流
    . 2005, 7(6): 460-461.
  • 不良事件
    . 2005, 7(6): 462-462.
  • 国外信息
    . 2005, 7(3): 233-234.
  • 不良事件
    . 2004, 6(3): 195-195.
  • ADE简报
    . 2000, 2(4): 267-267.
  • ADR咨询
    . 2000, 2(4): 277-277.
  • 病例报告
    . 2005, 7(4): 298-298.
  • 海外资讯
    . 2012, 14(3): 190-3.
  • 安全信息
    . 2011, 13(6): 358-1.
  • Wang Yiping, Qin Kan, Liu Fang, Chen Siyuan, Fan Luyan
    ObjectiveTo analyze the risks of hypertonic glucose injection ( 20%) (hypertonic glucose) in clinical application using failure mode and effect analysis (FMEA) method and improve the relevant management measures.MethodsA study group on risk prevention strategies of hypertonic glucose was established in the First People′s Hospital of Hefei. Domestic and foreign literature on medication error cases, preventive measures or management strategies, and data from questionnaires and on-the-spot investigations were collected. The failure modes in the process of hypertonic glucose application were analyzed and assessed. Severity (S), frequency of occurrence (O), and likelihood of detection (D) of the risks related to these failure modes were scored and the risk priority numbers (RPN) were determined. The failure modes with higher RPN were screened out and the corresponding prevention strategies were formulated. The incidence of medication errors and potential hazards, cognition rate of knowledge on drugs, qualification rate of drug storage, and satisfaction rate for management measures before and after the improvement were analyzed comparatively.ResultsAccording to the results from literature search, questionnaires, and on-the-spot investigations, a total of 24 failure modes were found in the 6 links relevant with hypertonic glucose application in clinical, which included links of prescription writing and delivery, pharmacist dispensing, nurse dispensing, post-administration monitoring, drug management, and information technology. Ranking the RPN from high to low, 7 major failure modes with higher RPN were selected from the 24 failure modes, including the existence of drugs with similar name and drugs with similar package, wrong drug dispensing, absence of post-administration monitoring, lack of marked labels for drugs, garbles caused by lack of medication knowledge, and untimely record and report of medication errors. The incidences of medication errors and potential safety hazards before and after management improvement were 3.2% (7/216) and 0.4% (1/234), respectively and the difference had no statistical significance (P=0.058). The average cognitive rates of physicians, nurses and pharmacists before and after the improvement were 65.2%(15/23), 54.2%(13/24), 67.9%(19/28) and 95.8%(23/24), 91.7%(22/24), 95.5%(21/22), respectively and the differences were statistically significant (P<0.05 for all). The qualification rates of drug storage before and after management improvement were 70.2%(151/215) and 98.7%(230/233), respectively and the difference was statistically significant (P<0.05). The average satisfaction degrees of medical staff with hyperosmotic glucose management were 81.3%(61/75) and 95.7%(65/70), respectively before and after the management improvement and the difference was statistically significant (P<0.05).ConclusionFailure modes in the process of hypertonic glucose use can be effectively identified using the FMEA method, and the risk events can be effectively reduced after the corresponding improvement measures.
  • Ding Zheng, Wang Ying, Chen Xingwei, Sha Lan, Zheng Yingli
    . 2017, 19(5): 364.
    Specific problems mainly related to anticoagulant therapy are present in women with prosthetic heart valve during pregnancy. Oral anticoagulants (OAC) indicated for valvular heart disease are highly efficacious for antithrombotic purposes, while OAC could cross the placenta increasing the risk of embryopathy, especially when the required warfarin dose was high daily or when warfarin is used in weeks 6-12 during pregnancy. Unfractionated heparins and low molecular weight heparin do not cross the placenta but they are not as effective as warfarin. The contradictions complicate the use of the anticoagulants. According to evidence-based medicine and guidelines, we should take corresponding personalized measures according to stages of pregnancy to minimize the risk of thrombosis and bleeding and the risk on maternal and fetal sides.
  • Wei Ailing, Wu Tao, Kang Ting, Liu Yan, Bai Hai, Wang Cunbang
    . 2017, 19(4): 315.
    A 15-year-old boy with chronic myelogenous leukemia, since acute conversion to lymphoblastic leukemia and central nervous system leukemia received oral dasatinib 50 mg twice daily. One year later, the boy′s color of partial hair and eyebrow became white. Three months later, dasatinib was replaced by imatinib mesylate due to diarrhea. Two months after dasatinib withdrawal, his hair returned to black. One week later, dasatinib 50 mg twice daily was given again due to leukemia relapse. Six months later, the color of part of his hair and eyebrow became white again.
  • Dong Yanhui
    . 2015, 17(6): 469-470.
    A 16-year-old boy received IV infusion of clindamycin 0.6 g twice daily after incision and drainage of anal abscess. Three days after initiation of clindamycin treatment, the boy developed palpitations and chest tightness. The ECG examination showed ST-segment depression and T wave inversion inⅡ,Ⅲ, and aVF leads. After excluding viral myocarditis, congenital heart disease, rheumatic myocarditis, the electrocardiographic ST-T changes in the patient was considered to be related to clindamycin treatment. Cardiac enzymes, ECG, and blood electrolyte changes were monitored and the patient′s palpitations and chest tightness disappeared after 2 days of symptomatic treatments. After 5 days of treatment, the electrocardiographic ST-T changes in the patient disappeared. At 1 month of follow-up, the boy′s symptoms did not recur and ECG examination showed normal findings.
  • Yang Siyun, Pan Zhaoping, Hu Yulan, Liu Hua, Wang Longfei, Hu Xiaoyan
    . 2015, 17(2): 155-157.
    A 45-year-old male received a lump resection on left maxillofacial and  cervical region. Before treatment, the laboratory test results were as follows: alanine aminotransferase (ALT) 19 U/L, aspartate aminotransferase (AST) 32 U/L, gamma glutamyltransferase (GGT) 146 U/L. He was given an intravenous infusion of propacetamol hydrochloride 2.0 g in 0.9% sodium chloride 100 ml twice daily. The laboratory tests were as follows: alanine aminotransferase 642 U/L, aspartate aminotransferase 692 U/L, gamma glutamyltransferase 368 U/L on day 8 after operation. The patient had no symptoms of nausea, vomiting, abdominal distention, and poor appetite. There was no tenderness in his hepatic zones. He was considered as acute liver injury due to propacetamol hydrochloride. Propacetamol hydrochloride was discontinued immediately and liver-protective drugs such as polyene phosphatidylcholine, reduced glutathione, and N-acetyl cysteine were given. On day 8 of drug withdrawal, the results of laboratory tests were as follows: ALT 87 U/L, AST 341 U/L, GGT 354 U/L. On day 32 of drug withdrawal, the laboratory tests results were as follows: ALT 24 U/L, AST 17 U/L, GGT 36 U/L.
  • Hua Lu, Jing Zhicheng
  • Hui Xiang, Fan Qingqing, Duan Yan, Yang Dihong, Ge Weihong
    Novel oral anticoagulants (NOAC) include direct thrombin inhibitors (ximelagatran and dabigatran etexilate) and coagulation factor Xa inhibitors (rivaroxaban, apixaban and edoxaban). Ximelagatran was withdrawn from the market in 2006 because of its high incidence of liver injury after listing in 2004, which has aroused concern about the hepatotoxicity of NOAC. No significant evidence of hepatotoxicity was found in pre-clinical studies on dabigatran etexilate, rivaroxaban, apixaban, or edoxaban and their risks of liver injury were low. However, pre-marketing clinical studies, post-marketing literature reports, and pharmacovigilance data showed that the incidence of NOAC-related liver injury was 0.1% to 1.0%. Reports of liver adverse events related to rivaroxaban were more than those related to apixaban and dabigatran etexilate. The patients who use NOAC have underlying diseases. Once liver injury occurs, it is more serious and the mortality is higher. Clinicians should be highly vigilant. The mechanism of NOAC-related hepatotoxicity is still unclear and further study is needed in the future.
  • Deng Xuanyu, Huang Juanjuan, Sun Ji, Huang Shiqiong, Li Yanfei, He Gefei
    Adverse Drug Reactions Journal. 2020, 22(6): 360-365. https://doi.org/10.3760/cma.j.cn114015-20200331-00322
    Objective To analyze the occurrence and risk factors of drug-induced liver injury (DILI) in patients with novel coronavirus pneumonia (COVID-19). Methods The medical records of patients with COVID-19 who were discharged from the First Hospital of Changsha from January 15 to March 7, 2020 were collected and the patients were divided into the DILI group and the non-DILI group based on DILI diagnostic criteria. Basic information of patients in the 2 groups including gender, age, underlying diseases, classification of COVID-19, liver function test results on admission and after medication, drug use, time to DILI onset after medication, and treatments and outcomes of DILI were recorded and compared. The incidence of DILI in patients with COVID-19 was calculated, and the factors whose P<0.05 in inter-group comparison were included in the multivariate logistic regression analysis to calculate the odds ratio (OR) and 95% confidence interval (CI). Results A total of 203 discharged patients with COVID-19 met the inclusion criteria. Of them, 36 patients developed DILI, the incidence was 17.73%. Between the DILI group and the non-DILI group (167 patients), the differences were statistically significant in gender distribution, proportion of patients with underlying diseases such as hypertension, fatty liver, and cholelithiasis, clinical classification of COVID-19, and the kinds of drug use (P<0.05 for all), but not statistically significant in levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBil) on admission (P>0.05 for all). The levels of ALT and AST in patients in the DILI group after medication were higher than those before medication, and the differences were statistically significant (P<0.001 for all). The median time for time to DILI onset after medication was 8 (6, 11) days and none of the patients had obvious clinical signs and symptoms. After the occurrence of DILI, 16 patients stopped the suspicious drugs and received liver- protective treatments, 6 patients only stopped the suspicious drug without additional treatments, and 14 patients received liver-protective treatments without drug withdrawal. Among the 36 patients in the DILI group, liver function were improved in 34 patients but did not returned to normal in 2 patients when they were discharged from the hospital. Multivariate logistic regression analysis showed that male (OR=3.939,95%CI: 1.426-10.883, P=0.008), being severe and critical in clinical classification (OR=6.433, 95%CI: 2.411-17.162,P<0.001), fatty liver (OR=3.815, 95%CI: 1.298-11.215, P=0.015), cholelithiasis (OR=16.347, 95%CI: 1.267-210.990, P=0.032), and the kinds of drug use >8 (OR=10.181, 95%CI: 3.606-28.744, P<0.001) were the independent risk factors of DILI in patients with COVID-19. Conclusions The incidence of DILI in COVID-19 patients discharged from the First Hospital of Changsha is 17.73%. Male, being severe and critical in clinical classification of COVID-19, fatty liver, cholelithiasis, and the kinds of drug use >8 are the independent risk factors for DILI patients with COVID-19.
  • 论著
    JIANG Shan;WU Ying-hui;LIU Xin
    . 2012, 14(4): 210-4.

    ObjectiveTo observe the safety of low-dose dexmedetomidine used in children undergoing combined inhaled and intravenous general anesthesia with tracheal intubation in order to provide the basis for safe drug use in clinical practice. Methods The children, who were scheduled to undergo radical surgery for snoring and surgical correction of entropion at Wuhan Medical Health Center for Women and Children from January to July in 2011, were enrolled in the study. The children were randomly divided into three groups: group A (receiving an IV infusion of dexmedetomidine 0.5 μg/kg at the beginning of anesthesia induction), group B (receiving an IV infusion of dexmedetomidine 1.0 μg/kg at the beginning of anesthesia induction) and group C (receiving no dexmedeto-midine). Combined inhaled and intravenous general anesthesia with tracheal intubation was used in children in the three groups. The children’s heart rate (HR), mean arterial pressure (MAP), pulse oxygen saturation (SpO2), partial pressure of carbon dioxide in end-expiratory gas (PetCO2), tidal volume and respiratory rate were observed and recorded. The degree of sedation was scored. The incidences of respiratory depression and dysphoria in the three groups were recorded. ResultsA total of 120 children aged 4-11 years were enrolled in the study, and comprised 80 boys and 40 girls. Each group consisted of 40 children. There were no statistically significant in baseline characteristics and the operation time among the children in the three groups (all P>0.05) . There was no statistically significant difference in SpO2, PetCO2, tidal volume and respiratory rate at different time points among the three groups (all P>0.05). The cases of respiratory depression after operation in groups A, B and C were one case (2.5%) , 2 cases (5.0%) and 5 cases (12.5%), respectively. The degree of respiratory depression remitted after administration of hyperbaric oxygen via a face mask. HR decreased and MAP increased in the children in groups A and B after receiving dexmedetomidine, but the changes were in normal range and returned to the baseline spontaneously after receiving atropine. The incidence of dysphoria in groups A and B after operation was 5.0% (2/40) and 2.5% (1/40), respectively, and was significantly lower than that in group C (22.5%, 9/40) (P<0.05 for all comparison). The incidence of excessive sedation in the children in the group B (12.5%, 5/40) was higher than that in the group A (2.5%, 1/40) (P<0.05). ConclusionAn IV infusion of low-dose dexmedetomidine(0.5 μg/kg) used in children undergoing combined inhaled and intravenous general anesthesia with intracheal intubation could prevent respiratory depression and dysphoria after surgery, and it might be a safe and effective regimen.

  • 不良事件
    . 2002, 4(6): 413-413.
  • 不良事件
    . 2003, 5(6): 413-413.
  • 监测交流
    . 2006, 8(2): 141-142.
  • 不良事件
    . 2003, 5(3): 202-202.
  • 不良事件
    . 2003, 5(2): 120-120.
  • Adverse Drug Reactions Journal. 2023, 25(11): 661-661. https://doi.org/10.3760/cma.j.cn114015-20231124-00837
        他汀类药物是治疗血脂异常的主要药物,通过抑制羟甲基戊二酸单酰辅酶A(HMG-CoA)还原酶而减少胆固醇的生物合成。其不良反应主要发生在肝脏和肌肉。在肌肉不良反应中,横纹肌溶解是最严重的,有可能致命,但极少有研究对不同他汀类药物之间横纹肌溶解的风险进行比较。
        该研究基于世界卫生组织的药物警戒数据库(VigiBase),比较了7种他汀类药物(阿托伐他汀、氟伐他汀、洛伐他汀、匹伐他汀、普伐他汀、瑞舒伐他汀和辛伐他汀)横纹肌溶解的风险(不包括西立伐他汀,因其引起严重的横纹肌溶解而于2001年撤市)。该研究包括了在2022年12月31日前服用他汀类药物的成年人中出现横纹肌溶解的所有报告,结果以报告比值比(ROR)及其95%置信区间表示。结果显示,在VigiBase的3 300余万份报告所涉及的患者中,有10 657例服用他汀类药物者出现横纹肌溶解(ROR=59.33,P<0.001),第1份报告于1995年上报;其中由医师上报的占52.4%。报告所涉及的患者中男性占61.5%,73.7%的患者为“严重”横纹肌溶解(其中373例死亡,5 363例导致或延长住院治疗)。
        他汀类药物中致横纹肌溶解风险最大者为辛伐他汀(4 357例,ROR=71.80),随后为阿托伐他汀(3 346例,ROR=33.93)、瑞舒伐他汀(1 777例,ROR=33.01)、氟伐他汀(242例,ROR=31.21)、匹伐他汀(169例,ROR=27.85)、普伐他汀(472例,ROR=24.45)和洛伐他汀(295例,ROR=17.69)(均P<0.001)。当将每种他汀类药物与所有其他他汀类药物进行比较时,辛伐他汀也是风险最大者(ROR=2.20,P<0.001)。
        总之,该研究表明致横纹肌溶解风险较大的他汀类药物是辛伐他汀和阿托伐他汀,对于有横纹肌溶解风险的患者应优先考虑其他他汀类药物,如普伐他汀。除因其不被细胞色素P450系统代谢以外,普伐他汀也是该研究中致横纹肌溶解风险较低的他汀类药物之一。
  • Bian Xiaoyuan, Cui Chao, Huang Wen, Li Hui, Liu Guiming
    Adverse Drug Reactions Journal. 2023, 25(5): 318-320. https://doi.org/10.3760/cma.j.cn114015-20230316-00190
    A 41-year-old female patient took decoction of Chinese medicine (containing 10 g of Fructus Lycii, 10 g of Radix Ginseng Rubra, and 15 g of Cortex Acanthopanax Radicis) by herself due to trigeminal neuralgia. After about 6 hours of medication, the patient developed palpitate suddenly, woke up in sleep, accompanied by dizziness. Her blood pressure was 95/63-mmHg. The electrocardiogram showed atrial fibrillation, and ventricular rate was 45 beats/min. Symptomatic treatments such as elevation of hypertension and improvement of myocardial metabolism were given, but the patient′s symptoms were not improved. After that, she developed nausea and vomiting, her heart rate decreased to 35 beats/min, and blood pressure decreased to 87/36-mmHg. Electrocardiogram showed junctional escape rhythm and T-wave change. Electrocardiogram monitoring and continuous oxygen inhalation, and symptomatic and supportive treatments such as continuous IV pumping of dopamine and dobutamine, and polarized solution were given. Eight days after treatment, the patient′s condition was improved. Electrocardiogram showed sinus rhythm. The patient sent the traditional Chinese medicine to a professional institution for identification, and found that it contained Cortex Periplocae, while the original prescription was Cortex Acanthopanax Radicis. Therefore, it is considered that the patient′s arrhythmia was caused by mistakenly use of excessive Cortex Periplocae.
  • Fan Caixia, Guo Dequn, Li Zhengrong, Sun Guiling
    Adverse Drug Reactions Journal. 2024, 26(5): 318-320. https://doi.org/10.3760/cma.j.cn114015-20230802-00578
    A 49-year-old male patient received long-term use of warfarin 5-mg once daily orally after the operation of aortic mechanical valve replacement, and the international normalized ratio (INR) was maintained at 1.80~2.50. The patient was treated with amiodarone due to atrial tachycardia, and developed nasal bleeding 1 week later. Laboratory tests showed prothrombin time (PT) 79.7-s, INR 10.17, serum creatinine (Scr) 1-032-μmol/L, and blood urea nitrogen (BUN) 29.4-mmol/L; urine routine examination showed urinary occult blood (+) and urinary protein (±). Considering that it was warfarin-related nephropathy caused by the combination of amiodarone, which can enhance the anticoagulant effect of warfarin, leading to excessive anticoagulation. Warfarin was discontinued and the treatments such as local hemostasis, vitamin K1, tranexamic acid, Bailing capsules (百令胶囊), lanthanum carbonate chewable tablets, and continuous hemodialysis were given. Five days of drug withdrawal, warfarin was restored. Two weeks later, laboratory tests showed PT 21.0-s, INR 1.82, Scr 179-μmol/L, and BUN 19.0-mmol/L. Renal function indicators were within the reference range at 2 and 6 months of follow-up.
  • 中药不良反应
    . 2006, 8(6): 460-461.
  • SARS防治
    . 2003, 5(3): 145-145.
    全球关注的SARS已在32个国家和地区流行,其中以我国的SARS疫情为重。在全国奋力抗击SARS之际,本刊愿为战胜SARS尽一份责、献一份力。为此,特辟“SARS防治”专栏,刊载有关SARS的信息资料,旨在对临床防治SARS有所助益。
  • 病例报告
    . 2002, 4(5): 340-340.
  • ADR监测
    . 2001, 3(3): 160-161.
  • ADE简报
    . 2001, 3(2): 125-125.
  • 病例报告
    . 2002, 4(6): 429-429.
  • 不良事件
    . 2002, 4(6): 399-399.
  • ADE简报
    . 2001, 3(4): 258-258.
  • 不良事件
    . 2004, 6(1): 55-55.
  • Gao Lingyan, Wang Yue, Liu Yuling, Deng Ang
    Adverse Drug Reactions Journal. 2020, 22(1): 44-45. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.01.010
    A 53-year-old female patient received oral ethambutol, pyrazinamide, isoniazid, and moxifloxacin, as well as intramuscular injection of capreomycin for drug-resistant tuberculosis. After 11 months of treatments, the patient developed nausea, vomiting, fatigue, weakness of limbs, gradually aggravating with soft paralysis of both legs. Laboratory tests showed the lowest values of serum potassium, sodium, calcium, phosphorus, and magnesium were 1.3, 128, 1.44, 0.20 and 0.38-mmol/L, respectively and creatine kinase (CK) increased to 13-517-U/L. The patient was diagnosed with electrolyte disorder and rhabdomyolysis. After 14 days of treatments with intravenous and oral supplementation of potassium, magnesium, calcium, and phosphorus, as well as oral spironolactone, the levels of serum potassium, sodium, calcium, phosphorus, and magnesium were 4.1, 141, 2.31, 1.13, and 0.67-mmol/L, respectively. The patient′s muscle strength recovered well and the patient could walk autonomously.
  • Ye Hong, Li Junjie, Wu liyong
    Adverse Drug Reactions Journal. 2021, 23(5): 225-227. https://doi.org/10.3760/cma.j.cn114015-20210414-00459
    With the widespread use of various new antineoplastic agents in clinic, there are more and more reports of posterior reversible encephalopathy syndrome associated with new antineoplastic agents. The pathogenesis of new antineoplastic agent-related PRES is mainly related to endothelial dysfunction. The clinical manifestations of new antineoplastic agent-related PRES are lack of specificity, including headache, confusion, visual loss, visual field defect, seizure, and focal neurological deficit, etc. Imaging examinations in some patients show reversible bilateral subcortical angiogenic oedema, which is regarded as typical imaging findings. At present, unified diagnostic criteria of PRES have not been formulated. The core of the treatment is dose reduction or drug withdrawal, and other symptomatic treatments such as blood pressure control and anti-epileptic treatment are also necessary. The prognosis is good in most patients if timely treatment is given.
  • Yang Yue, Zhan Cheng, Zhang Yingchun
    A 30-year-old male patient was treated with 3 courses of itraconazole capsules for toenail onychomycosis (each treatment course was 4 weeks, itraconazole capsules 200 mg twice daily was given for 7 successive days at the first week of each course). The patient took the medicine regularly and did not take other medicines simultaneously according to the doctor′s advice. At the end of the first course, erectile dysfunction occurred; the patient did not care about it and continued taking the medicine. The patient′s toenail onychomycosis was cured after 3 courses of treatment; however, the score of International Index of Erectile Function (IIEF-5) was 10 (a moderate erectile dysfunction). Itraconazole capsules were stopped and his life style was adjusted, 3 months later, his symptom was not improved markedly. Sildenafil citrate tablets and treatment with therapeutic device for sexual dysfunction were given and, 3 months later, his IIEF score was 22 and erectile function was greatly improved.
  • Wang Haifei
    . 2015, 17(1): 67-2.
    A 71-year-old man with Parkinson′s disease received levodopa and benserazide hydrochloride 0.25 g twice daily for two years. Olanzapine 2.5 mg twice daily was added to his regimen for brain organic mental disorders. On day 3, the patient developed agitation and received an intramuscular injection of chlorpromazine 50 mg. On day 5, he developed temperature of 38.8 ℃, elevated serum creatine kinase (424 U/L), and muscle rigidity. On day 11, he presented with temperature of 39.2 ℃, stupor, and soy-colored urine. Laboratory tests showed the following findings: white blood cell count 9.5×109/L, neutrophile granulocyte 0.9, and creatine kinase 939 U/L. Neuroleptic malignant syndrome was diagnosed. Olanzapine and levodopa and benserazide hydrochloride were withdrawn. Meanwhile symptomatic and supportive treatments such as naloxone, medium and long chain fat emulsion, compound amino acid, enteral nutritional suspension, and dexamethasone were given. On day 13, his body temperature returned to within normal range. On day 15, the creatine kinase level decreased to 109 U/L. On day 17, levodopa and benserazide hydrochloride was resumed.
  • Zhang Yi,Qu Yong
    . 2015, 17(5): 376.
    A 61-year-old woman with pain due to bone fracture applied diclofenac diethylamine emulgel over the local skin. About 2 hours after the drug use, red rash appeared on the sites where the medicine was applied and erythema was accompanied by itching and pain on the back, loin and internal side of both thighs. On day 2 of drug use,the patient′s temperature increased to 39.2 ℃. Scarlatiniform rashes appeared on the sites mentioned above. She received antianaphylactic treatment. Three days later, her temperature returned to normal, the erythra decreased, and the itching was alleviated. One week later, the erythra mostly disappeared.
  • 会议纪要
    Men Yan
    . 2014, 16(3): 185-2.
  • Liu Liang, Wang Jimei
    . 2015, 17(5): 396.
    A 5-year-old girl with fever received nimesulide granules 50 mg which was bought by her parents. Sixteen hours later she developed abdominal pain and gross hematuria. She received nimesulide granules 50 mg again because of fever. About 3 hours later the above-mentioned symptoms  recurred. Laboratory tests showed the following values: white blood cell count (WBC) 24.5×109/L, Neutrophil count (NEU) 14.5×109/L, red blood cell count (RBC) 1.6×1012/L, and hemoglobin (Hb) 193×109/L. She was diagnosed as hemolytic anemia in the other hospital and received the fluid therapy and human immune globulin and dexamethasone for 5 days. Then her urine color turned light, RBC and Hb increased to 2.7×1012/L and 83.0 g/L, respectively. One day 7 of morbidity she was hospitalized in our hospital. Blood routine examination showed the following values: WBC 18.7×109/L, NEU 10.5×109/L, RBC 2.8×1012/L, Hb 93.0 g/L, PLT 521×109/L,and absolute value of  reticulocyte (Ret) 320×109/L. She received azithromycin for infection, and symptomatic treatment (dexamethasone and glutathione). Ten days later, the blood routine examination showed: WBC 17.2×109/L, NEU 12.6×109/L, RBC 3.5×1012/L, Hb 114.0 g/L, PLT 575×109/L and Ret 150×109/L. Hematuria did not occur again in this patient.
  • Deng Ying, Ge Ping
    . 2016, 18(1): 67.
    A 61-year-old male with hypertension received oral irbesartan 150 mg/d and levamlodipine besylate 2.5 mg/d. The therapy was replaced with one tablet of irbesartan and hydrochlorothiazide (containing irbesartan 150 mg and hydrochlorothiazide 12.5 mg) once daily and levamlodipine besylate 2.5 mg/d due to poor efficacy. Eight hours after taking the first irbesartan and hydrochlorothiazide, the patient developed erythema in left upper extremity and blister appeared in locoregional skin accompanied by the increase of skin temperature and pain. There were hyperaemia, edema, diffusing red congestive maculopapule and vesicular rash all over the whole patient′s body skin the second day. Bulla was visible in torsos, hands and feet. Skin lesions were severe in chest and upper limbs. He had facial edema and eyelid swelling and was diagnosed as epidermolysis bullosa. Irbesartan and hydrochlorothiazide was stopped and the patient received an IV injection of dexamethasone 5 mg once daily. On day 6, the skin hyperaemia alleviated, the color of skin rashes became dark, and vesicular rash decreased. Dexamethasone was stopped and he was given oral loratadine 10 mg once daily. On day 8, the erythema gradually subsided in torsos、upper extremity and eyelid, skin temperature was normal and a part of skin was scabby. Eleven days later on follow-up, the skin lesion all disappeared.
  • Zou Yuzhen, Feng Lei
    . 2016, 18(4): 305.
    A 36-year-old female patient received methotrexate/vindesine chemotherapy for mixed acute leukemia. She was treated with intravenous infusion of methotrexate (8 g lasting for 24 hours, on the first day and the 15th day), intravenous infusion of vindesine (4 mg on the first day) and intramuscular injection of pegaspargase (3 750 U, on the 5th day). Her blood concentration of methotrexate was 0.94 μmol/L 20 hours after her first dose. During the second dose, the patient developed epigastric pain. She was treated with intravenous infusion of omeprazole 40 mg once daily. The next day, the patient developed intermittent abdominal pain and mucous stool 5-6 times daily. Her blood concentration of methotrexate was 17.64 μmol/L. Methotrexate intoxication was considered. Intravenous infusion of calcium folinate 1 g every 6 hours and gargling with calcium folinate 30 mg+0.9% sodium chloride 500 ml thrice daily was given immediately. On the third day, the patient developed oral mucosal ulcer and was treated with recombinant basic fibroblast growth factor and lidocaine for external application. On the 4th day, the blood concentration of methotrexate was 1.53 μmol/L, abdominal pain and ulcer was improved. The patient was treated with calcium folinate 36 mg intramuscularly every 6 hours. On the 6th day, the blood concentration of methotrexate dropped to 0.67 μmol/L.
  • Zhang Qingxia, Yan Suying, Li Xiaoling, Zeng Yan, Wang Yuqin
    ObjectiveTo understand and analyze the occurrence of medication errors with methotrexate tablets and their related factors in order to avoid or reduce the adverse events occurring.MethodsAll medication error reports in National Monitoring Network for Clinical Safe Medication from September 22, 2012 to September 21, 2017 were collected and the reports of medication errors with  methotrexate tablets were selected. And the grading and content of medication errors with methotrexate tablets, the persons who found medication errors, and the triggering factors for medication errors were analyzed.ResultsA total of 25 119 reports of medication errors from the 204 hospitals of 25 provinces and municipalities in our country were collected by National Monitoring Network for Clinical Safe Medication between September 22, 2012 and September 21, 2017.The reports of medication errors with methotrexate tablets accounted for 0.14% (35 /25 119) of the total reports of medication errors. The reports of serious medication errors(E-I) with methotrexate tablets accounted for 3.18%(7/220) of the total reports of serious medication errors. The reports of medication errors with methotrexate tablets involved 34 patients, including 16 males and 18 females aged 25-87 years. The 34 patients included 20 cases of rheumatoid arthritis, 6 cases of psoriasis, 2 cases of systemic lupus erythematosus, 2 cases of leukemia, 1 case of connective tissue disease, 1 case of polymyositis, 1 case of hypertension, and 1 case of toxic diffuse goiter. Of the 35 cases of medication errors, 18 cases(51.43%) were classified as class B, 9 cases(25.71%) as class C, 1 case (2.86%) as class D, 1 case(2.86%) as class E, 5 cases(14.28%) as class F, and 1 case(2.86%) as class I. The serious medication errors accounted for 20.00% of medication errors with methotrexate tablets. Four patients had both wrong dose and wrong frequency of administration. Among the medication errors with methotrexate tablets, the frequency of administration errors ranked first, accounting for 53.85%(21/39) in total. All patients mistook "once weekly" for "once daily". Wrong dose ranked the second, accounting for 30.77%(12/39) in total. Wrong drug class ranked the third, accounting for 7.69% (3/39) in total. The persons who triggered the medication errors with methotrexate tablets included doctors 74.29%(26/35), pharmacists 17.14%(6/35), and patients or their family members 8.57% (3/35). Twenty-six cases of medication errors with methotrexate tablets were triggered by doctors, of them, 24 were discovered and intercepted by pharmacists. Of the 6 cases of medication errors triggered by pharmacists, 3 cases were discovered and intercepted by pharmacists, and one case was discovered and intercepted by a doctor. These medication errors did not cause any harm to the patients. Four cases that were not intercepted and 3 cases triggered by patients or their families were all serious medication errors, of which 1 caused death. Of the persons who discovered the medication errors, pharmacists accounted for 77.14% (27/35), and doctors accounted for 22.86% (8/35). The main factors causing medication errors were lack of related pharmacologic knowledge(45.71%, 16/35), copying error(20%, 7/35), similar drug name or adjacent packing boxes (8.57%, 3/35).ConclusionsMedication errors with methotrexate tablets often occurred in patients with autoimmune diseases. The content of medication errors with methotrexate tablets mainly due to wrong frequency of administration. The incidence of serious medication errors was high, it might cause death. The main cause of medication errors with methotrexate tablets in treating non-neoplastic diseases was lack of understanding of frequency administration "once weekly". Pharmacists might play an important part in detecting and intercepting medication errors with methotrexate tablets.
  • 法规准则
    . 2007, 9(2): 125-129.
  • 安全信息
    . 2012, 14(3): 189-1.
  • 安全信息
    . 2011, 13(2): 84-1.
  • 病例报告
    Liu Jianfeng;Liu Ran;Tu Xiaojuan
    . 2011, 13(1): 61-2.
    A 40yearold man who had normal thyroid function and nodular goiter developed palpitation and hyperhidrosis on day 10 while he was receiving oral compound iodine solution 10 drops thrice daily before surgery. The thyroid function tests showed the following levels: triiodothyronine 3.21 nmol/L, thyroxine 142.10 nmol/L, free triiodothyronine 8.80 pmol/L, free thyroxine 28.18 pmol/L, thyroidstimulating hormone 0.03 mU/L. The compound iodine solution was discontinued immediately and oral methimazole 10 mg was given twice daily. After one month of treatment, his thyroid function became normal, and then he underwent surgical treatment.
  • 论著
    Cui Weihua;Tan Hong;Han Ruquan;Li Yanping;Li Shuren
    . 2011, 13(1): 1-6.
    Objective: To study the effect of lowdose lidocaine on the efficiency of induction and maintenance of propofol anesthesia. Methods: Forty ASA physical status ⅠorⅡpatients aged 18-65 years, who were scheduled to undergo elective thoracotomy under general anesthesia with propofol, were enrolled in the study and randomly divided into the following two groups by using ballot method: the lidocaine group and the control group (20 patients in each group). The administration sequence during the anesthetic induction and maintenance in the two groups were as follows: (1) the patients received an IV infusion of midazolam maleate 0.03 mg/kg; (2) the patients in the lidocaine group were initially administered an IV infusion of lidocaine 1 mg/kg, followed by a continuous IV infusion of lidocaine 33 μg·kg-1·min-1, and the patients in the control group were administered the same volume of 0.9% sodium chloride at the same rate; (3) the patients received an IV infusion of remifentanil 1 μg/kg, followed by a continuous IV infusion of remifentanil 0.2 μg·kg-1·min-1; (4) an IV infusion of propofol was given, the initial target propofol blood concentration for induction was 1 ml/L, and then increased in steps of 0.3 mg/L at a time, achieving a stable bispectral index (BIS) of 4060; (5) rocuronium was given intravenously 0.6 mg/kg after the patients lost consciousness. The differences in BIS, heart rate, invasive arterial pressure(IAP), target propofol blood concentration, effect compartment propofol concentration, pharyngonasal temperature, doses of atropine or ephedrine or nitroglycerin, adverse reactions and complications in the two groups at the different time points during intraoperative period were monitored and compared. The patients’lidocaine blood concentrations were monitored. Results: The lidocaine group comprised 13 males and 7 females with average age of (54±9)years. The control group comprised 13 males and 7 females with average age of (51±1)years. There were no statistically significant differences in baseline patient characteristics, doses of atropine or ephedrine or nitroglycerin, BIS, IAP, pharyngonasal temperature, and the incidence of adverse reaction between the two groups. There were no serious adverse reactions and complications in the two groups. The target propofol blood concentration and effect compartment propofol blood concentration in the lidocaine and control groups at the different time points were respectively compared as follows: at the time of tracheal intubation, the concentrations were(1.9±0.4) mg/L vs(2.4±0.4) mg/L and (1.2±0.4) mg/L vs (1.6±0.4) mg/L,respectively;at the time of organ resection, the concentrations were (2.0±0.5) mg/L vs (2.7±0.7) mg/L and (2.0±0.5) mg/L vs (2.7±0.7) mg/L, respectively;at the time of chest cavity shut, the concentrations were(1.7±0.4) mg/L vs(2.2±0.7) mg/L and (1.8±0.4) mg/L vs (2.3±0.7) mg/L, respectively; at the time of tracheal extubation, the concentrations were(0.8±0.2) mg/L vs(0.9±0.2) mg/L and (0.9±0.2) mg/L vs(1.0±0.3) mg/L, respectively. The differences were statistically significant (all P<0.05). The patients’ lidocaine blood concentration 30, 120, 240 minutes after anesthetic induction and after surgery completion were(2.24±0.53), (2.20±0.42), (2.45±0.73) and (2.31±0.75) mg/L, respectively, and they were lower than a toxic blood concentration of lidocaine (8.0 mg/L). Conclusion: The low-dose lidocaine can increase the efficiency of induction and maintenance of propofol anesthesia.
  • 不良事件
    . 2003, 5(6): 412-412.
  • 不良事件
    . 2005, 7(4): 311-311.
  • 药物安全动态
    . 2006, 8(2): 152-152.
  • 不良事件
    . 2002, 4(5): 348-348.
  • Chen Manru, Liang Cuilyu, Zhang Yin, Chen Qiying, Chen Caiyun
    Adverse Drug Reactions Journal. 2023, 25(5): 299-307. https://doi.org/10.3760/cma.j.cn114015-20220824-00774
    Objective To systematically evaluate the efficacy and safety of reslizumab targeting interleukin 5 in adjuvant therapy for patients with refractory asthma. Methods The PubMed, Embase, Cochrane Library, Clinicaltrials.gov, CNKI, VIP, and Wanfang databases were searched (up to June 2022). Randomized controlled trials (RCTs) of reslizumab in adjuvant therapy of refractory asthma were collected. On the basis of conventional treatment for asthma, patients in the trial group was given additional reslizumab while the control group was given placebo. Primary outcome measures included the acute asthma attacks incidence, the changes of forced expiratory volume in the first second (FEV1), asthma control questionnaire (ACQ) score, asthma quality of life questionnaire (AQLQ) score, and blood eosinophil count before and after adjuvant therapy, and incidence of adverse events. RevMan 5.3-software was used for meta-analysis. The effect sizes of counting data were odds ratio (OR) and its 95% confidence interval (CI), while the effect sizes of measurement data were mean difference (MD) and its 95%CI. Results A total of 7 RCTs and 2-506 patients were entered in the analysis, including 1-456 in the trial group and 1-050 in the control group. The meta-analysis showed that, compared to the control group, the acute asthma attacks incidence was lower in patients of the trial group during adjuvant therapy[18.1%(263/1-456) vs. 31.3%(329/1-050), OR=0.50, 95%CI: 0.41-0.62, P<0.001]; FEV1 and AQLQ score after treatment were higher (MD=0.13 L, 95%CI: 0.08-0.17 L, P<0.001; MD=0.18, 95%CI: 0.04-0.33, P=0.01); the ACQ score and blood eosinophil count were higher (MD=-0.19, 95%CI: -0.28--0.10, P<0.001; MD=-0.45×109/L,95%CI:-0.48×109/L--0.42×109/L,P<0.001). There were no statistically significant difference in the incidences of overall adverse events, serious adverse events, allergic reactions, and pneumonia compared to those in the control group [63.7% (928/1-456) vs. 71.4% (750/1-050), OR=0.76, 95%CI: 0.55-1.06, P=0.10; 6.4% (93/1-456) vs. 8.2% (86/1-050), OR=0.91, 95%CI: 0.66-1.24, P=0.55; 0.4% (5/1-403) vs. 0.1% (1/997), OR=1.66, 95%CI: 0.41-6.65, P=0.47; 0.6% (9/1-456) vs. 1.0% (10/1-050), OR=0.81, 95%CI: 0.35-1.87, P=0.63]. Conclusion Reslizuma has a good efficacy and safety profile in adjuvant treatment for patients with refractory asthma.
  • Wang Yuting, Chen Min, Zeng Minghui
    Adverse Drug Reactions Journal. 2021, 23(6): 321-323. https://doi.org/10.3760/cma.j.cn114015-20201120-01160
    Two patients (patient 1, a 72-year-old female; patient 2, a 52-year-old female) received immune checkpoint inhibitors for adenocarcinoma of right lung and melanoma, respectively. Patient 1 received an IV infusion of navacizumab 100-mg on the first day and 2 weeks was a cycle. In the 7th cycle of immunotherapy, Patient 1 developed vitiligo-like skin depigmentation around her lip and on the hairline, which was not treated because of no symptoms of pain or itching. In the 23rd cycle of immunotherapy, the area of vitiligo-like depigmentation reduced. In the 26th cycle of immunotherapy, reexamination showed progression of tumor. Patient 2 received an IV infusion of pablizumab 100-mg on the first day and 3 weeks was a cycle. In the 9th cycle of immunotherapy, she developed vitiligo-like depigmentation around the lip and on the hairline, which was not treated because of no symptoms of pain or itching. In the 15th cycle of immunotherapy, the area of vitiligo-like depigmentation increased and asymmetric round vitiligo mass appeared on the back and waist. Reexamination showed no tumor progression. Both the 2 patients did not use other drugs that might cause vitiligo-like skin depigmentation during immunotherapy. It was considered that the skin vitiligo-like depigmentation was probably related to immune checkpoint inhibitors.
  • 法规准则
    . 2008, 10(2): 131-4.
  • 病例报告
    LIANG Yong-tao;LU Xin-ting
    . 2012, 14(2): 125-2.
    A 22-year-old male patient developed paroxysmal convulsive torticollis 1 week after trauma, which occurred 3 times within one hour and each episode lasted for 15-20 minutes and then improved spontaneously, tetanus was suspected and he was hospitalised. The patient was given symptomatic treatment, however, paroxysmal attacks of convulsive torticollis still occurred repeatedly. A inquiry into his history revealed that he was given a single dose of oral penfluridol 40 mg by his family member who suspected him to have “schizophrenia” on admission day. About 7 hours after taking the medicine, the above symptoms appeared, and then his symptoms resolved within 15-20 seconds. A review of his history, penfluridol was considered the most likely cause of extrapyramidal reactions and IM scopolamine hydrobromide 0.3 mg was given. Paroxysmal myoclonus frequency decreased. Subsequently, the patient received oral trihexyphenidyl 2 mg three times daily and, one day later, the above-mentioned symptoms disappeared completely. His symptoms did not recur at a 2-week follow-up.
  • 病例报告
    ZHANG Yan;SU Ying-ying
    . 2012, 14(1): 44-2.

    A 22-year-old woman was hospitalized with viral encephalitis accompanied by symptomatic epilepsy and received an IV infusion of acyclovir 0.5 g in 0.9% sodium chloride 250 ml every eight hours, oral perphenazine 4 mg every eight hours, oral olanzapine 2.5 mg every morning and 5 mg every night, and oral valproate sodium 0.5 g every twelve hours. Before admission, she had been prescribed oral perphenazine 4 mg every eight hours and olanzapine 5 mg every night for 7 days because of viral encephalitis. On day 5 after admission, she developed galactorrhea and, on day 6, her prolactin (PRL) level was 5.93 nmol/L. Then the dose of perphenazine was reduced by 2 mg each day and, until twelve days after admission, perphenazine was stopped. However, acyclovir, olanzapine, and valproate sodium were continued. On the day of drug withdrawal, her PRL level was 4.11 nmol/L. On day 8 of perphenazine discontinuation, her symptom of galactorrhea vanished and the PRL level returned to normal range (1.28 nmol/L).

  • 误用滥用
    ZHANG Zuo-wen;SA Jun-peng;CHE Fu-you;HU Dai-ying
    . 2012, 14(2): 105-2.
    A 46-year-old man with parkinson’s disease received benserazide with an initial dose of 125 mg three times daily for one year and the patient took benserazide 250 mg four times daily for 1.5 years himself due to progressively worsening symptoms. Subsequently, he adjusted benserazide dosage to 125 mg every 1.5 hours ( daily total dose 1375 mg) himself again in order to completely control his symptoms. About three months later, his left limbs developed paroxysmal involuntary movements. Benserazide was stopped and the above symptoms were gradually alleviated. From the fourth day of discontinuation, the patient received benserazide 250 mg four times daily again and involuntary twitching of his left limbs relieved gradually. One week later, the twitching of his limbs did not appear again and involuntary movements of his limbs did not recur at a 3-month follow-up.
  • ADR咨询
    . 1999, 1(1): 17-17.
  • Zhou Jingliang, Guan Xiaodong, Wu Xinjing, Peng Binbin
    A 74-year-old male patient with hypertension was admitted to hospital because of aphasia and movement disorder of his right limb for 3 hours. He was diagnosed as acute cerebral infarction. Thrombolytic therapy with alteplase (1 mg/ml) was given 1 hour and 17 minutes after admission. Intravenous injection of alteplase 6.48 mg was given firstly (within 1-2 minutes of completing the injection) and then 58.32 mg was administered intravenously via an infusion pump. About 10 minutes after treatment with alteplase, the patient suddenly developed pallor, drenching sweats, cold limbs, and unconsciousness; his blood pressure dropped from 169/89 mmHg to 112/68 mmHg. Alteplase-induced anaphylaxis was considered. Alteplase was immediately stopped and oxygen inhalation and liquid supplements were given. At the same time, dopamine, diphenhydramine, dexamethasone, and other anti-anaphylactic and anti-shock agents were immediately given. The next morning, the patient developed anemia, RBC 2.12×1012/L, Hb 66 g/L. That night, hematoma appeared in his deep muscle from the right hip (at the injection site) to thigh. The peripheral hematoma was considered to be induced by alteplase. On the 3rd day of admission, the patient developed cerebral palsy and was discharged by his family′s request.
  • Chen Xiao, Ruan Yi, Chen Jia
    . 2018, 20(1): 60.
    A 29-year-old female patient with Crohn′s disease received prednisone orally. The initial dose was 40 mg daily, then gradually decreased to 25 mg daily after 3 months. Because of recurrence of her illness, the dose prednisone was restored  to the initial level and azathioprine (50 mg daily) was added. After 23 days, the patient developed persistent abdominal pain with nausea and vomiting. Laboratory tests showed the following values: white blood cell 13.4×109/L, neutrophile granulocyte 86.3%, eosinophil count 0.41×109/L, serum amylase 336 U/L, serum lipase 1 084 U/L. The result of abdominal CT showed exudation in pancreas tail, with  fuzzy images in surrounding fat spaces. The patient was diagnosed as acute pancreatitis induced by azathioprine. Azathioprine and prednisone were stopped, and the patient received fasting, fluid resuscitation, inhibition of pancreatic secretion, and analgesic. On day 8 of symptomatic treatment, the patient′s abdominal symptom disappeared, without nausea and vomiting. The result of laboratory tests showed serum amylase 63 U/L, serum lipase 47 U/L. On day 10, the treatment of Crohn′s disease was adjusted to intramuscular injection of methotrexate 25 mg once a week, and oral prednisone 40 mg daily. The results of following up for 3 months showed that the patient did not show symptoms of vomiting and persistent pain in the upper abdomen.
  • Wang Yong, Shan Benjie, Shen Xiabo, Huang Dabing
    Adverse Drug Reactions Journal. 2020, 22(12): 713-715. https://doi.org/10.3760/cma.j.cn114015-20200316-00280
    Two patients (patient 1, a 63-year-old female; patient 2, a 22-year-old male) were treated with anlotinib for lung adenocarcinoma and synovial sarcoma, respectively. Patient 1 developed cough, expectoration, and dyspnea after 8 cycles of anlotinib treatment (12-mg orally once daily, 2 weeks of treatment and 1 week of withdrawal as a treatment cycle). Spontaneous pneumothorax was diagnosed by chest CT. The spontaneous pneumothorax was considered to be related to anlotinib. Then the drug was stopped. After thoracic cavity closed drainage therapy, the patient′s dyspnea was relieved. Due to the progress of the disease, the patient received reduced-dose anlotinib treatment (10-mg/d, with the same usage as before). Spontaneous pneumothorax recurred in the first cycle. Anlotinib treatment was terminated and the sympto- matic treatments including thoracic cavity closed drainage, expectorant, anti-infection, and nutritional support were given. Ten days later, chest X-ray examination showed that pneumothorax was cured. Patient 2 developed spontaneous pneumothorax (found by chest CT examination) after 9 cycles of treatment with anlotinib (12-mg/d, with the same usage as that in patient 1). But the patient had no obvious discomfort and continued to use anlotinib under close monitoring of respiratory status.
  • Xu Zhiying, Xu Xiaodong
    . 2017, 19(5): 397.
    A 68-year-old male patient with postoperative colon cancer received recombinant human interleukin-11 1.5 mg once daily by subcutaneous injection for platelet reduction after chemotherapy with capecitabine and oxaliplatin. Four days later, the patient developed bilateral conjunctival hyperemia, facial and lower limbs edema. Interleukin-11 was stopped. The symptoms gradually alleviated 1 day later. The above-mentioned symptoms aggravated at re-injection of interleukin-11 the next day. Interleukin-11 was stopped again. One day later, the patient′s conjunctival hyperemia, facial edema disappeared and lower limbs edema was improved.
  • Li Liushui, Liu Xianjun, Wang Xin
    . 2017, 19(4): 314.
    A 16-year-old female middle school student took progesterone soft capsule 100 mg twice daily orally for 13 days in compliance with her doctor′s advice to manually adjust the menstrual cycle in order to take the physical fitness test. She had not received any other drugs during the same period. The patient developed binocular diplopia on the 4th day after drug withdrawal. Neurological and ophthalmic examinations showed no abnormal signs; it was considered that the girl′s symptom was caused by mental stress and she was not given any treatment. The patient took esculin and digitalis glycosides eye drops (one drop, 3 times daily) and Haoshili (好视力) eye-patch (kept for 8 minutes on bilateral temple once daily) by herself. Thirteen days later, her symptom of binocular diplopia was improved. Seven months later, her binocular diplopia disappeared completely. The girl′s binocular diplopia was considered to be induced by progesterone soft capsules.
  • Zhang Lei, Xie Cheng
    . 2017, 19(3): 232.
    A 68-year-old male patient with incomplete spinal cord injury received an intramuscular injection of salmon calcitonin 50 U once daily, IV infusion of monosialotetrahexosylganglioside sodium 40 mg, and gugua extracts 50 mg once daily. On day 8 of drug administration, the patient received intramuscular injection of salmon calcitonin, then continued to receive IV infusion of monosialote-trahexosylganglioside sodium. About 30 minutes later, the patient developed rash on his back. The IV infusion was discontinued and anti-allergic treatments were given immediately. After that, IV infusion of gugua extracts was given successively. On day 9 of drug administration, the degree of patient′s erythra became more serious, all the drugs were stopped at the same day. On day 6 of drug withdrawal, the patient developed fever, massive herpes and diabrosis all over the body. He was diagnosed as epidermolysis bullosa. The patient received the symptomatic treatments including physical cooling, glucocorticoid, human immune globulin, and skin wound treatment. On day 37 of drug withdrawal, his symptoms of skin improved gradually.
  • Zhu Jianhui, Shao Xiying, Wang Zeng
    . 2015, 17(5): 382.
    A 32-year-old woman with breast cancer received a postoperative adjuvant chemotherapy with epirubicin plus cyclophosphamide followed by paclitaxel. The drug regimen of paclitaxel was intravenous infusion 120 mg once a week. On the day 6 after the first cycle of paclitaxel treatment, the patient developed bilateral big toenail hollowness, the aperture was about 2 mm. She was given the second cycle of paclitaxel according to the original plan. Six days later, the hollow toenail was worsened with slight pain. Paclitaxel was stopped. Mecobalamin, erythromycin ointment and keeping warm of feet were applied. Four days later, the pain was reduced, and the toenail hollowness did not continue to enlarge.
  • Wang Na, Xu Enxi, Pan Qiqi, Luo Can
    Adverse Drug Reactions Journal. 2020, 22(1): 46-47. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.01.011
    A 4-month-old premature infant with broncho-pulmonary dysplasia was hospitalized and received imipenem and cilastatin sodium combined with erythromycin for severe pneumonia. During hospitalization, erythromycin was stopped because of exacerbation of infection and replaced by vancomycin hydrochloride 60-mg dissolved in 5% glucose injection 15-ml by an IV infusion at a speed of 60-mg/h. About 10-minutes of vancomycin treatment, the infant developed cry and noisy and facial flushing. Then the infusion speed was slowed down, but the infant was still crying and his skin erythema increased, which gradually fused into pieces on his neck, chest and limbs. And his heart rate increased to 160 beats/min. Red man syndrome induced by vancomycin was considered. Vancomycin was stopped immediately and no antiallergic agents were given. About one hour later, the skin rash disappeared gradually and the heart rate decreased to 140 beats/min. The next day, the skin color returned to normal. Then teicoplanin combined with imipenem and cilastatin sodium were given according to the results of drug sensitivity test in sputum culture. The rash did not recur. Two weeks later, his pneumonia improved and he was discharged.
  • Yuan Ling, Shen Wei, Li Shuang, Yang Qing, Tong Deyin
    A 32-year-old female patient with hyperthyroidism received methimazole 10 mg orally thrice daily. Three weeks later, she developed fatigue, anorexia, deep-colored urine, and pruritus of whole body skin. Methimazole was stopped. Laboratory tests showed the total bilirubin (TBil) of 463.1 μmol/L, bilirubin direct (DBil) of 348.9 μmol/L, alanine aminotransferase (ALT) of 142 U/L, aspartate aminotransferase (AST) of 64 U/L, and alkaline phosphatase (ALP) of 499 U/L. Cholestatic hepatitis induced by methimazole was considered. The patient received IV infusion of reduced glutathione, polyene phosphatidylcholine, hepatocyte growth-promoting factors, alprostadil, adenosylmethionine 1,4-butanedisulfonate, and methylprednisolone sodium succinate, and oral ursodeoxycholic acid capsules. Thirteen days later, the laboratory tests showed TBil of 432.3 μmol/L, DBil of 260.6 μmol/L, and total bile acid (TBA) of 564.0 μmol/L. The patient received 4 times of plasmapheresis within 8 days because her pruritus was not improved. On day 3 after the last plasmapheresis, laboratory tests showed TBil of 271.3 μmol/L, DBil of 175.3 μmol/L, and TBA of 483.0 μmol/L. Liver-protective drugs and medications used to treat jaundice were continued. On day 47 after the last plasmapheresis, laboratory tests showed TBil of 22.4 μmol/L, DBil of 8.3 μmol/L, ALT of 35 U/L, AST of 20 U/L, ALP of 114 U/L, and TBA of 47.0 μmol/L. On day 51 after the last plasmapheresis, her pruritus and yellowish skin and sclera disappeared, her urine color returned to normal, and her physical strength recovered.
  • Guo Yingying, Wang Xiaoxia
    Tumor necrosis factor-α (TNF-α) plays an important role in inflammatory responses and immune system diseases. TNF-α inhibitors, including etanercept, infliximab and adalimumab, have become the effective therapies of some diseases such as rheumatoid arthritis, glomerular disease, psoriasis, and inflammatory bowel diseases. With the popularization of their clinical applications, there are more and more reports of new-onset or aggravated psoriasis caused by TNF-α inhibitors. This kind of adverse reactions may be related to cytokine imbalance among TNF-α, interleukins, and interferon etc., as well as to the genetic susceptibility. Types of TNF-α inhibitors and the blood concentration may also have contributions to the development of psoriasis.
  • 国外文献题录
    . 2004, 6(1): 60-61.
  • ADR咨询
    . 2005, 7(4): 315-315.
  • 病例报告
    Xu Lijun
    . 2011, 13(5): 312-2.

    A 24-year-old male patient with epilepsy received long-term use of sodium vedproate with no obvious effect. The therapy was replaced with 1 tablet of phenobarbital and sodium bromide thrice daily, 2 tablets of compound phenobarbital nitrazepam and chlorphenamine after lunch and 1 tablet after supper, and 4 Jiulonghuafeng pills thrice daily. One and a half months later, he presented with red maculopapule on his facial, trunk, and upper limbs, which then spread to his entire body, accompanied by lip ulceration, high fever, facial edema, cough and expectoration. Above-mentioned drugs was discontinued. Laboratory tests revealed the following levels: ALT 742 U/L, AST 279 U/L, ALP 406 U/L, γ-GT 1123 U/L, CRP 57.4 mg/L, CK 235 U/L, CK-MB 60 U/L, α-HBDH 561 U/L, LDH 899 U/L. Antiepileptic drug-induced hypersensitivity syndrome was diagnosed. The patient was given an IV infusion of methylprednisolone. After 6 days of treatment, his symptoms improved markedly, repeat liver function tests showed a ALT level of 165 U/L, a AST level of 55 U/L. On day 25 of admission, He recovered and was discharged.

  • ADR监测与防治
    . 2000, 2(4): 236-239.
  • 不良事件
    . 2003, 5(4): 272-272.
  • 不良事件
    . 2003, 5(2): 122-122.
  • 病例报告
    . 2004, 6(2): 123-124.
  • ADE简报
    . 2000, 2(2): 131-131.
  • Wang Yan, Fei Yuanyuan, Ji Huichun
    Adverse Drug Reactions Journal. 2022, 24(1): 37-39. https://doi.org/10.3760/cma.j.cn114015-20210518-00587
    A 34-year-old female patient intermittently ate 7 or 8 raw Dioscorea bulbifera L. due to rhinitis. After a 1-year interval, she ate 1 raw Dioscorea bulbifera L. again. Four days later, the patient developed nausea and yellowish skin and sclera. Laboratory tests showed alanine aminotransferase (ALT) 732-U/L, aspartate aminotransferase (AST) 597-U/L, gamma glutamine transferase (γ-GT) 204-U/L, alkaline phosphatase (ALP) 202-U/L, total bilirubin (TBil) 203.7-mmol/L, and direct bilirubin (DBil) 122-mmol/L. Abdominal magnetic resonance imaging showed early liver cirrhosis, and liver transient elastography showed early liver fibrosis. The liver injury caused by viral hepatitis, autoimmune hepatitis, hepatolenticular degeneration, abnormal iron metabolism and other reasons was excluded by various laboratory examinations. It was considered that the liver injury was associated with Dioscorea bulbifera L. Then liver-protective drugs such as magnesium isoglycyrrhizinate injection, polyene phosphatidylcholine injection, reduced glutathione for injection, ademetionine 1,4-butanedisulfonate for injection, and ursodeoxycholic acid were given. Forty-two days later, the patient′s symptoms disappeared basically and laboratory tests showed TBil 55.3-mmol/L, DBil 18.1-mmol/L, ALT 24-U/L, AST 25-U/L, γ-GT 44-U/L, and ALP 124-U/L.
  • 安全信息
    . 2006, 8(6): 468-468.
  • 监测简报
    . 2003, 5(3): 196-196.
  • 病例报告
    Ren Rujing;Wang Gang;Tang Huidong
    . 2011, 13(5): 305-2.

    A 35-year-old man received thiamphenicol 0.5 g thrice daily and flavoxate hydrochloride 0.2 g thrice daily for prostatitis accompanied with urinary tract infection. Five months later, the patient developed pain in his feet, followed by numbness and electric shock-like pain in both lower limbs. Electromyogram and other accessory examination revealed peripheral neuropathy. Thiamphenicol and flavoxate hydrochloride were withdrawn, and then some group B vitamins and gabapentin were given. A week later, his symptoms relieved.

  • 病例报告
    Song Lu;Liu Aihua
    . 2011, 13(5): 303-2.

    A women at the age of 14 started receiving an initial dose of carbamazepine 300 mg/d and then the dosage was gradually increased to 600 g/d for epilepsy. After ten years treatment, the patient developed seroperitoneum, thrombocytopenia. She had a platelet level of 5×109/L, The drug was discontinued and switched to levetiracetam. Laboratory examination revealed an antinuclear antibody (ANA) titre of 1∶320, and anti-double stranded DNA(anti ds-DNA) antibodies 261 IU/ml. Drug-induced lupus erythematosus-like syndrome was considered to be associated with carbamazepine, the patient was given prednisone, and her seroperitoneum significantly improved. Fifth days after carbamazepine withdrawal, her platelet count was 103×109/L, ANA and anti ds-DNA test results were negative. lupus erythematosus-like syndrome did not recur.

  • 病例报告
    Zhang Xiating;Liu Gang;Sun Wei
    . 2011, 13(6): 391-2.
    Two female patients with epilepsy, aged 15 and 54 years, received traditional antiepileptic drugs without good response, and then received oral levetiracetam 0.25 g twice daily, on days 5 and 7 of treatment, they developed red maculopapular rash with pruritus on their extremities and trunk, respectively. The rash was considered to be associated with levetiracetam. The rash of patient 1 subsided on day 3 after levetiracetam withdrawal. The rash of patient 2 disappeared after discontinuation of levetiracetam and receiving loratadine 10 mg once daily for one week.
  • Zhou Anqin, Luo Min, Zhang Dengliang, Xu Ting
    Adverse Drug Reactions Journal. 2020, 22(1): 42-43. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.01.009
    A 75-year-old male received an IV infusion of moxifloxacin hydrochloride injection (moxifloxacin) 400-mg/d once daily for valvular heart disease complicated with heart failure and pulmonary infection. On the second day, the electrocardiogram showed that the corrected QT interval (QTc) was prolonged from 455-ms before treatment to 490-ms. On the third day, amiodarone hydrochloride for injection (amiodarone) 150-mg was given by slow intravenous injection in the early morning due to atrial fibrillation and 300-mg of amiodarone was continuously pumped at the speed of 30-mg/h at noon. In the afternoon of the 4th day, amiodarone 300-mg was given again via a pump at a speed of 30-mg/h. About 20-minutes later,the QTc was prolonged to 607-ms. On the 5th day, amiodarone was not given again, but the QTc continued to be prolonged up to 674-ms. On the 6th day, the QTc gradually returned to be within the normal range after discontinuation of moxifloxacin. The prolongation of QT interval in the patient was considered to be associated with moxifloxacin and amiodarone.
  • 安全信息
    . 2014, 16(1): 61-1.
  • Liu Yan, Ma Qing, Xing Yunli, Chen Ying, Zhao Zhen, Wang Mengran, Xiao Yao, Dou Liyang, Zhang Jian
    . 2017, 19(3): 195.
    ObjectiveTo investigate the association between warfarin drug effects and vitamin K epoxide reductase complex subunit 1 (VKORC1)-1639 G/A gene polymorphisms in Han Chinese very elderly patients. MethodsThe subjects were elderly patients aged more than 60 years, with stable anticoagulation with warfarin and the target international normalized ratio(INR), who were hospitalized in Beijing Friendship Hospital, Capital Medical University from August 2009 to August 2016. The patients were divided into the very elderly group and aged group. The first record of warfarin dosage, the duration of achieving stable dosage (defined as the initial stage of treatment) and warfarin stable dosage were recorded. The bleeding and embolism events during early treatment were observed. After INR was at the steady state, genotyping for the VKORC1-1639 G/A alleles were tested. The effects of drugs and complications in warfarin initiation therapy were also investigated. ResultsA total of 322 patients were enrolled, including 300 cases of atrial fibrillation and 22 cases of pulmonary embolism. The very elderly group had 200 cases, including 110 males and 90 females; their ages ranged from 75 to 96 years, the average age was (83+7). The aged group had 122 cases, including 68 males, 54 females, their ages ranged from 60 to less than 75 years, the average age was (67±8). The VKORC1-1639 G/A genotype included 256 cases of AA type (79.5%) which contained 150 males and 106 females, and 62 cases of type AG (19.3%) which contained 26 males and 36 females. The GG type included 4 cases (1.2%), containing 2 males and 2 females. Genotype distribution accorded with the law of genetic equilibrium. There was no significant difference in VKORC1-1639 G/A genotype distribution between the aged group and the very elderly group (P>0.05). The carriers of VKORC1-1639 AG+GG genotype had a significantly higher warfarin stable dosage than those of AA genotype [(2.90±1.39)mg vs. (2.00±1.14)mg, t=5.39, P<0.01]. In the same genotype, the very elderly patients had a decreased warfarin stable dosage compared with the aged patients [AA: (1.62±1.24)mg vs. (2.58±0.98)mg, t=6.68, P<0.01; AG+GG: (2.43±0.55)mg vs. (3.36±1.52)mg, t=3.97, P<0.01]. The AG+GG patients have a longer time to achieve stable dosage-effect relation compared with AA genotype [(18.9±2.8)d vs. (11.2±2.5)d, t=4.28, P=0.01].ConclusionsWarfarin stable dosage was related to patient age and VKORC1-1639 gene polymorphism. According to the results of VKORC1-1639 genotype testing to adjust warfarin dose maybe have some clinical significance in Han elderly patients.
  • Wang Jianshe, Fei Jian, Zhang Xifeng
    . 2015, 17(4): 309.
    An 8-year-old girl was scheduled to undergo appendectomy for acute appendicitis. Preoperative conditions were normal. Scopolamine 0.2 mg was intramuscularly injected 30 min preopera-tively. Anesthesia was induced by penehyclidine hydrochloride(0.3 mg), midazolam (1.0 mg), fentanyl (80 μg), propofol (80 mg) and rocuronium (25 mg), and propofol (6-8 mg·kg-1·h-1) and remifentanil (0.2-0.5 μg·kg-1·min-1) for maintenance. Surgery went smoothly and safely.After three hours,the patient complained of blurred vision, and delirium. Bilateral pupils enlarged as compared with that of normal age, light reflex was normal.Ophthalmological consultation considered it as anticholinergic drug-induced mydriasis, with no special treatment. About 15 h postoperatively delirium disappeared and about 50 h postoperative blurred vision disappeared.
  • Su Jun, Zhang Ying, Hu Wei
    . 2015, 17(4): 302.
    A 43-year-old woman received hormone replacement therapy because of menopause. She took 1 tablets of estradiol valerate/cyproterone acetate a day orally for 21 days continually and had an interval for 7 days, she repeated the cycle continuously. Her serum triglyceride (TG) was 1.55 mmol/L before the drug administration and increased to 3.25 mmol/L 18 months after the beginning of the treatment which was  the result of a laboratory examination performed before blood donation. She took dietary control only. She developed abdominal pain, abdominal distention, nausea and vomiting after eating greasy food 24 months after the treatment started. She was hospitalized the next day. Laboratory examination revealed that TG was 23.00 mmol/L, amylase 892 U/L, lipase 560 U/L, urine amylase 1 020 U/L. Abdominal ultrasound examination showed diffuse enlargement of pancreas and obvious peripancreatic exudation. The patient was diagnosed as acute hyperlipidemic pancreatitis. Estradiol valerate/estradiol cyproterone was stopped. She received the symptomatic treatments, including fasting, gastrointestinal decompression, plasmapheresis, anti-inflammatory drugs, acid suppression, enzyme inhibition, and fluid resuscitation. The patient received plasmapheresis for 6 times totally. Her serum TG levels were 18.50, 15.00, 11.70, 9.20, 5.20 and 2.20 mmol/L, respectively. Twenty days later, all the symptoms of the patient disappeared completely and the patient was discharged.
  • Wang Hongyan, Li Jing, Hua Can, Wang Qing, Niu Shaoli, Tian Haitao
    Adverse Drug Reactions Journal. 2021, 23(4): 205-207. https://doi.org/10.3760/cma.j.cn114015-20201008-01016
    A 56-year-old male patient underwent percutaneous coronary intervention (PCI) due to acute ST elevation myocardial infarction. He received a combination therapy with aspirin enteric coated tablets 100-mg orally once daily and ticagrelor 90-mg orally twice daily for antiplatelet aggregation after the PCI. The patient had a history of gout for more than 20 years. On the 24th day of medication, the patient developed fever and the symptoms of redness, swelling, heat, and pain in multiple joints. Laboratory tests showed white blood cell count 9.8×109/L, neutrophils 0.83, and blood uric acid 538-μmol/L. Ultrasonography of the joints showed swelling and thickening of some joint cysts, limited thickening of soft tissue, and scattered crystalline deposits on the articular cartilage. He was diagnosed as having gouty arthritis, which might be associated with ticagrelor. Ticagrelor was stopped. The patients were treated with dual antiplatelet therapy consisting of aspirin 100-mg orally once daily and clopidogrel 75-mg orally once daily. At the same time, the treatments of diet control, strengthening exercise, and urate lowering drugs were given. Ten days later, the result of reexamination showed that serum uric acid was 287-μmol/L. Therefore, dual antiplatelet therapy with aspirin and ticagrelor was resumed, and no further gouty arthritis attacks occurred.
  • 安全信息
    . 2011, 13(5): 336-1.
  • HU Bin;GE Ting-jie;LOU Yue-fen
    A 93-year-old woman was hospitalized with repeated vomiting and difficulty in eating. Renal function test showed the following results: creatinine (Cr) 90 μmol/L,blood urea nitrogen (BUN) 10 mmol/L. An IV infusion of amino acid compound injection 500 ml and alanyl glutamine injection 100 ml were given once daily. On day 5 after administration, the renal function test showed the following results: Cr 122 μmol/L,BUN 51 mmol/L. No special treatment was given. On day 12 after administration, laboratory tests revealed the following levels: Cr 120 μmol/L, BUN 62 mmol/L, K+ 6.0 mmol/L,Na+ 157 mmol/L,Cl- 134 mmol/L. The patient developed mental confusion. Amino acid compound injection and alanyl glutamine injection were stopped. The supplement volume of potassium, sodium, and fluid were adjusted at the same time. Four days later, the patient received parenteral-nutrition solution again due to her condition. An IV infusion of only amino acid compound injection 500 ml once daily was given for one week. Laboratory review showed the following results: Cr 126 μmol/L, BUN 29.7 mmol/L. Henceforth, her BUN level did not increase again.

     

  • 不良事件
    . 2002, 4(5): 345-345.
  • 不良事件
    . 2003, 5(3): 198-198.
  • 病例报告
    . 2002, 4(4): 260-260.
  • 不良事件
    . 2002, 4(5): 347-347.
  • WHO信息
    . 2004, 6(4): 275-275.
  • 安全信息
    . 2011, 13(1): 16-1.
  • ADR咨询
    . 2001, 3(2): 140-140.
  • ADR咨询
    . 2000, 2(2): 83-83.
  • Wu Guiying, Li Hongbin, Bai Lijie, Tie Ning, Wang Yong
    Adverse Drug Reactions Journal. 2021, 23(4): 207-209. https://doi.org/10.3760/cma.j.cn114015-20200811-00857
    A 64-year-old female patient with hypertension took telmisartan 40-mg orally twice daily without doctor′s advice due to poor blood pressure control with amlodipine treatment. After taking telmisartan for 1 week, she developed oral, vulvar, and perianal ulcers, accompanied by swelling and pain, and the symptoms were gradually aggravated. She was diagnosed with Behcet disease in the local hospital and dexamethasone was given for 10 days. Then dexamethasone was stopped because of the improvement of the symptoms but the rash was aggravated again. After attending the Department of Rheumatology and Immunology in the Affiliated Hospital of Inner Mongolia Medical University, he was diagnosed with fixed drug eruption, which was considered to be caused by telmisartan. Methylprednisolone, cetirizine, mouthwashes, cold-compresses on the rash were given and telmisartan was switched to nifedipine controlled-release tablets. After 10 days of treatments, the patient′s skin symptoms were improved obviously. At 3 months of follow-up, the rash did not recur.
  • Zhu Jing, Yan Yingying, Zhai Suodi, Cui Yimin
    Adverse Drug Reactions Journal. 2021, 23(5): 252-259. https://doi.org/10.3760/cma.j.cn114015-20210317-00319
    Objective To systematically evaluate the safety of cinepazide maleate injection (cinepazide) in treatment of stroke. Methods Randomized controlled trials (RCTs) of cinepazide combined or not combined with basic treatment (the trialed group) and basic treatment and other drugs except cinepazide alone or in combination (the control group) for stroke were collected by searching related databases at home and abroad (up to December 31, 2020). The outcome indicators were treatment-related adverse events (AEs), including symptoms such as headache, insomnia, drowsiness, and skin itching and abnormalities in laboratory tests such as liver and kidney function and blood system. The methodological quality of studies was evaluated using the Cochrane collaboration risk of bias tool. RevMan 5.3-software was used in meta-analysis and the effect values were expressed as relative risk (RR) and its 95% confidence interval (CI). Results A total of 19 RCTs were included in the analysis, all of which were post-marketing studies conducted in China. The 19 RCTs involved 3-272 patients, including 1-650 in the trialed group and 1-622 in the control group. The quality evaluation results showed possibility of selection bias and measurement bias in the research. Meta-analysis showed that difference in the incidence of adverse events between the trialed group and the control group was not significant [6.90%(114/1-650) vs. 7.64%(124/1-622), RR=0.92, 95%CI: 0.72-1.17, P=0.49]. The analysis results of 5 subgroups divided according to different doses (80, 160, 240, 320 and 400-mg/d) showed that difference in the incidence of adverse events between the trialed group and the control group was not significant [8.77%(10/114) vs. 14.16%(16/113), RR=0.62, 95%CI: 0.29-1.31, P=0.21;  3.51%(4/112) vs. 0(0/101), RR=4.58, 95%CI: 0.55-38.49, P=0.16; 0.88%(1/114) vs. 1.85%(2/108), RR=0.64,95%CI: 0.10-3.86, P=0.62; 7.53%(96/1-275) vs. 8.30%(105/1-265), RR=0.92,95%CI: 0.71-1.19, P=0.51; 8.57%(3/35) vs. 2.86%(1/35), RR=3.00, 95%CI: 0.33-27.46, P=0.33]。Analysis of several concerned AEs showed differences in the incidences of adverse events such as headache, dizziness, insomnia, nausea, rash/itching, and hemocytopenia between the trialed group and the control group were not significant [3.45%(57/1-650) vs. 3.45%(56/1-622), RR=1.02, 95%CI: 0.70-1.47, P=0.46; 2.24%(37/1-650) vs. 2.40%(39/1-622), RR=0.95, 95%CI: 0.60-1.51, P=0.76; 0.84%(41/1-650) vs. 2.10%(34/1-622), RR=1.23, 95%CI: 0.77-1.94, P=0.69; 0.67%(11/1-650) vs. 0.12%(2/1-622), RR=0.96, 95%CI: 0.39-2.39, P=0.64; 0.36%(6/1-650) vs. 0.37%(6/1-622), RR=1.06, 95%CI: 0.45-2.49, P=0.89; 0.06%(1/1-578) vs. 0(0/1-552), RR=3.00, 95%CI: 0.12-74.47, P=0.50]。 Conclusion Cinepazide marketed in China has good clinical safety.
  • Zheng Junfu, Dang Yan, Yu Yanhua, Li Lei, Lou Jinli, Ding Huiguo
    . 2017, 19(2): 89-95.
    ObjectiveTo investigate the strain distribution of ascitic pathogens in patients with spontaneous bacterial peritonitis (SBP) and the changes of sensitiveness to antibacterials from 2009 to 2016. MethodsThe medical records of SBP patients who were hospitalized in Beijing Youan Hospital from 2009 to 2016 were collected. The results of ascites bacterial culture of SBP patients were all positive. The results of ascites culture, pathogen identification, and the drug sensitivity test were recorded. The changes of distribution of ascitic pathogens and the sensitiveness to antibacterials were analyzed according to the time interval of every two years.ResultsA total of 1 107 SBP patients were enrolled in the study. Of them, 816 patients were male with average age (54±10) years, 291 patients were female with average age (57±13) years. There were 1 042(94.1%) patients with positive bacterial culture of ascites and 65 patients (5.9%) with positive fungal culture of ascites among the 1 107 patients, respectively. There were 920(83.11%) patients with end-stage liver disease, 113 (10.2%) with biliary tract disease, and 74(6.68%) with other diseases in the 1 107 patients. A total of 1 441 strains of pathogenic bacteria were identified, comprised of gram negative (G-) bacteria 637 (44.2%) strains, gram positive (G+) bacteria 739(51.3%) strains, and fungi 65(4.5%) strains. During 2009 to 2016, the top four number of strains of G-bacteria in SBP patients′ascites from high to low were Escherichia coli [213(14.8%)], Klebsiella pneumoniae [146 (10.1%)], Pseudomonas aeruginosa[52(3.6%)] and Enterobacter cloacae[38(2.6%)]; the top four strains of G(+) bacteria were Enterococcus faecium[176(12.2%)], Staphylococcus epidermidis[132(9.1%)], Staphylococcus haemolyticus [130(9.0%)] and Enterococcus faecalis [75(5.2%)] ; and the top 2 of fungi in SBP patients′ ascites were Candida albicans[36(2.5%)] and Candida glabrata[12(0.8%)].  Compared with the time interval of 2009-2010, the constituent ratio of G(-) bacteria in 2015-2016 was decreased significantly [49.3%(73/148)vs. 39.4% (196/498), P=0.031 ] , the constituent rate of fungi was increased significantly [6.4%(32/498) vs. 2.0% 3/148), P=0.038]. There were no statistical significance in G(+) bacteria′s constituent ratio among different time intervals . The constituent rate of extended spectrum beta-lactamases (ESBL) in Escherichia coli was higher in the time interval of 2015-2016 than that in the time interval of 2009-2010 [57.4% (35/61) vs. 32% (8/25), P=0.033]. The drug resistance of Escherichia coli to imipenem and meropenem were increased significantly during the same period (P=0.026, P=0.025). The results of drug sensitivity tests showed that G(-) bacteria was sensitive to imipenem, meropenem, amikacin and piperacillin/tazobactam; G(+) bacteria was sensitive to linezolid, teicoplanin and vancomycin. ConclusionsThe distribution of ascitic pathogens in SBP patients who were hospitalized in Beijing Youan Hospital from 2009 to 2016 present the tendency of decreasing of G(-) bacteria and increasing of fungi. The main pathogenic bacteria of SBP are drug-resistant. The resistance rates of Escherichia coli to imipenem, meropenem and cefotaxime have increased year by year.
  • Liu Donghua, Xing Xiaomin, Yang Xue, Liang Yu, Zhao Jun, Liu Xuelian, Yu Jing, Liu Yuefen
    Adverse Drug Reactions Journal. 2022, 24(3): 155-157. https://doi.org/10.3760/cma.j.cn114015-20210513-00551
    A 25-year-old male patient received intravenous infusion of tegacyclin 50-mg once per 12-hours from the 3rd day after renal transplantation because the bacterial culture of the donor kidney preservation solution showed carbapenem resistant Acinetobacter baumannii. On the 4th day after using tegacyclin, the patient developed epigastric pain, which was improved after gastric protection treatment. On the 8th day of medication, the patient developed persistent severe pain in his left lower abdomen. On the 9th day of medication, laboratory tests showed amylase 1-188-U/L and lipase 699-U/L. Pancreatic ultrasonic examination suggested acute edematous pancreatitis. Acute pancreatitis was diagnosed, which was considered to be related to tigecycline. Tigecycline was stopped. An IV infusion of octreotide acetate injection 0.6-mg dissolved in 0.9% sodium chloride injection 50 ml twice daily was given and diet was prohibited at the same time. Five days later, his symptoms of abdominal pain was improved significantly, pancreatic amylase decreased to 69-U/L, and lipase decreased to 646-U/L.
  • Zhao Hong, Liu Yingxia, Xie Qing, Li Jun, Yan Ming, Xu Jianming, Liu Jiajun, Dou Xiaoguang, Chen Chengwei, Mao Yimin, Xie Wen
    Adverse Drug Reactions Journal. 2023, 25(7): 405-412. https://doi.org/10.3760/cma.j.cn114015-20221226-01169
    Objective To investigate the prevalence, clinical characteristics, risk factors, and prognosis of chronic drug-induced liver injury (DILI). Methods A multicenter, open, retrospective, non-interventional epidemiological survey was conducted. According to the inclusion criteria, patients with DILI and hospitalized in 308-hospitals in China from January 1, 2012 to December 31, 2014 were enrolled, and medical records of the patients were collected. The patients with DILI were divided into chronic and acute DILI groups. The clinical characteristics, laboratory tests, and prognosis in patients of the 2 groups were compared, and the suspected drugs that induced the liver injury were analyzed. Univariate and multiva- riate logistic regression analyses were used to analyze the influencing factors of chronic DILI. Results A total of 25-927 patients were enrolled in the study, including 22-556 (87%) with acute DILI (acute DILI group) and 3-371 (13%) with chronic DILI (chronic DILI group). In the chronic DILI group, there were high proportion of women and the patients were older in age; more patients were with a history of liver disease and the time from medication to DILI was longer; more patients had digestive system symptoms (including loss of appetite, abdominal distension, nausea, vomiting, etc.), fatigue, jaundice, pruritus, liver pain/discomfort, bleeding tendency; the alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, and international normalized ratio were higher, while the serum albumin and platelet counts were lower; the proportion of patients with model for end-stage liver disease score ≥ 15 was higher; the all-cause mortality rate and liver disease-related mortality rate were higher, compared with the acute DILI group. The differences above-mentioned were statistically significant (all P<0.05). Multivariate logistic regression analysis showed that male was protective factor [odds ratio (OR)=0.76, 95% confidence interval (CI): 0.69-0.83], while previous liver disease history (OR=2.00, 95%CI: 1.82-2.19) and hypoalbuminemia (OR=0.96, 95%CI: 0.95-0.96) were independent risk factors for chronic DILI. Conclusions In the study period, the proportion of chronic DILI among DILI inpatients is 13.0% in the 308 hospitals. Compared with those with acute DILI, more chronic DILI patients were female, and patients with chronic DILI have higher ages, severer conditions, and poorer prognoses; female, previous liver disease history, and hypoalbuminemia are independent risk factors for chronic DILI.
  • Ma Liping, Zhu Jianxin, Zhao Jihong, Shen Sijing
    . 2016, 18(2): 156.
    A 23-year-old female patient received Dabaidu capsules (1 g, thrice daily) for facial acne. Three days after the use of the medicine, the patient developed stomachache. The pain worsened after meal and affected her sleep. Dabaidu capsules was stopped by herself. Three days later, the stomachache disappeared. However, her stomach discomfort lasted for 7 days. Then, domperidone (10 mg, thrice daily) and pantoprazole (40 mg, once daily) were given. Two days after the treatments, the patient′s stomach discomfort disappeared. At one week of follow-up, her symptoms did not recur.
  • ADR咨询
    . 2001, 3(1): 66-66.
  • ADR咨询
    . 2004, 6(1): 64-64.
  • 误用滥用
    LIU Feng-rong;YI Yan-chun
    . 2012, 14(3): 170-2.
    A 6-year-old male child with epilepsy had received oral phenytoin sodium, lamotrigine, sodium valproate, and phenobarbital. Because of his irregular use of the drugs, he developed repeated epileptic seizures which progressively worsened. His parents gave him oral oxcarbazepine 300 mg thrice daily themselves and the above-mentioned symptoms did not reappear. However, 40 days later, he experienced unstable walking and torpid response, and his epilepsy symptoms became aggravated. The patient was diagnosed with epilepsy, generalized tonic-clonic seizure, oxcarbazepine-induced disorientation, and ataxia on admission. Oxcarbazepine was stopped, and sodium valproate, reduced glutathione, and vitamin C were given. The next day, his epilepsy symptoms were controlled and, on day 8, his disorientation and ataxia resolved. So he was discharged. He received regularly sodium valproate and clonazepam after discharge and epilepsy seizure, disorientation, and ataxia did not recur at one-month follow-up.
  • 中药不良反应
    LONG Mei-fei;LONG Xiong-chu;ZHAO She-hai
    . 2012, 14(3): 188-2.

    A 44-year-old male patient deliberately ingested about 50 tablets of reserpine, and he was brought to the hospital emergency department with vomiting, nausea, dizziness, and asthenia. The patient was treated with an IV infusion of 50 ml of Xuebijing injection in 0.9% sodium chloride 250 ml. About 5 minutes later, the patient suddenly presented with tachypnea, hidrosis, facial flushing, palpitation, chest tightness, and dyspnea. Moreover, his blood pressure was 73/50 mm Hg, his heart rate was 93 beats/min and, his respiratory rate was 22 breaths/min. The infusion was stopped immediately. Hydrocortisone, dexamethasone, and dopamine were given and, in the meantime, he underwent oxygen inhalation and electrocardiogram monitoring. Thirty minutes later, his conditions improved and blood pressure increased to 106/76 mm Hg.

  • 病例报告
    CHENG Ming;SONG Hai-qing;DING Jian-ping;MEI Shan-shan;DU Ji-chen;LI Ji-lai
    . 2012, 14(4): 245-2.
    A 56-year-old man received an IV infusion of acyclovir 0.5 g diluted in normal saline solution 250 ml three times daily and an IV infusion of mannitol 125 ml four times daily for viral meningitis. On day 5, an IV infusion of sodium aescinate 20 mg in saline solution 250 ml once daily at a rate of 60 drops/min within 60 minutes was added to the regimen. About 8 hours after infusion completion, the patient developed discomfort and a sensation of fullness in the ear, tinnitus, and decreased sound resolution. The next day, His ear discomfort and tinnitus subsided, but decreased sound resolution did not markedly improve. Pure tone audiometry showed moderate high frequency hearing loss in both ears and sensorineural hearing loss. Four days later, sodium aescinate was given again and the dosage and administration were the same as before. Ten hours later, hypoacusis, ear discomfort, and tinnitus recurred and, the next day, ear discomfort and tinnitus disappeared, whereas decreased sound resolution did not markedly improve. Vitamin C and vitamin B complex were given and, about two months later, his hearing apparently recovered.
  • 学术论坛
    . 2013, 15(1): 4-2.
  • ADR咨询
    . 2003, 5(1): 63-63.
  • . 2015, 17(2): 150-151.
    A 48-year-old female patient with abdominal pain was diagnosed as "acute pancreatitis" at the local hospital and received IV infusion of fluorouracil 1.0 g, pantoprazole sodium 120 mg and amino acid (18AA) 250 ml once daily. On day 11 of treatments, she developed mucous bloody stool with tenesmus, fever with alopecia, and exfoliative changes of her hand-foot skin. Ulcerative colitis was considered. Drugs above mentioned were stopped and glucocorticoid treatment was given. After 3 months of hormone treatment, her mucous bloody stool relieved, the abdominal pain exacerbated, and alopecia and hand-foot damages was not improved. Then, she came to Xijing Hospital. Pathological examination of living tissue in colonic mucosa showed no crypt structure changes. According to the patient′s history, changes of hair and hand-foot skin,and her pathological examination results, the drug-induced colitis and hand-foot syndrome was considered. The dosage of glucocorticoid was gradually reduced and stopped at last. Propylamine acyl glutamine was given to repair the intestinal mucosa and keep the balance of the gut bacteria and intestinal nutrition, metronidazole for anti-infection, and enteral nutrition for supportive treatments. After 5 days of treatments, the patient′s symptoms of abdominal pain and mucous bloody stool relieved, hair loss and skin damage recovered gradually. At 4 months of follow up, abdominal pain and bloody stool did not recur and her hair and skin returned to normal.
  • 会议纪要
    Yan Suying;Li lili;Zeng Yan
    . 2014, 16(3): 191-1.
  • Cong Jia, Wang Jingwen
    ObjectiveTo understand the incidence and clinical characteristics of late-onset neutropnia (LON) caused by rituximab.MethodsThe medical records of patients treated with rituximab from hospital information system in Beijing Tongren Hospital, Capital Medical University from December 1, 2012 to March 31, 2017 were collected and retrospectively analyzed. The criteria for neutropenia was defined as neutrophil count <1.5×109/L. ResultsA total of 166 patients were enrolled, including 94 males and 72 females, 16~90 years old and the average age was (63±11) years. Of the 166 patients, 158 had B cell lymphoma, 6 had immune thrombocytopenia, and 2 had optical neuromyelitis. The number of treatment course of rituximab was 2-16 and the median number of treatment course was 5. Among the 158 patients with B cell lymphoma, 37, 30, 22, and 66 cases were in the Ann Arbor stage I, II, III, and IV, respectively, and 27 cases had bone marrow infiltration. Of the 166 patients, 19 patients (11.4%) developed 20 cases of LON, of which 10 (6%) had grade 3-4 neutropenia(6 cases of grade 3, 4 cases of grade 4); the median time for the last use of rituximab to LON occurrence was 56 days (22-105 days), and the median number of the lowest neutrophil count was 0.95×109/L[(0.05-1.47)×109/L]. Three patients(all grade 4 neutropenia) developed complications (including 1 patient with pneumonia/bacteremia, 1 with herpes zoster, and 1 with fever) during neutropenia, and all recovered after use of granulocyte colony-stimulating factor (GCSF) and antibiotics or antiviral treatments. Of 19 LON patients, 5 patients(4 cases of grade 4 neutropenia, 1 cases of grade 3) received GCSF treatment, 14 patients did not receive special intervention, and the median duration of neutropenia was 16 days (5-42 days). The occurrence of LON was not related to age, gender, disease stages and bone marrow infiltration, but the IgM level and B lymphocyte count in LON patients were significantly lower than those in patients without-LON (P<0.001) 6 months after drug withdrawal.ConclusionsThe rate of LON induced by rituximab was 11.4% in our hospital. The 2-3 grade neutropenia caused by rituximab are mostly self limiting, and the prognosis is good.Patients with 4 grade neutropenia may be complicated with infection, so GCSF therapy is needed.
  • 安全信息
    . 2006, 8(5): 394-394.
  • 中药不良反应
    Yin Anning;Wang Ruhua
    . 2008, 10(5): 0-0.
    A 36yearold woman presented herself to the clinic with fatigue and worsening lumbago. Urinalysis revealed 35 RBCs/high power filed and 2+ proteinuria. Laboratory investigations also revealed a BUN level of 10.1 mmol/L and a SCr level of 176 μmol/L. Chronic nephritis was diagnosed. The patient was given an IV infusion of Shenkang injection 60 ml plus 5% glucose 250 ml. She presented with difficulty breathing, marked asthma, tearing, runny nose, tinnitus, conjunctival congestion, and wheezing in both lungs about 5 minutes after administration of the infusion. Her symptoms were relieved after treatment with oxygen, adrenaline, and dexamethasone.
  • ao Kang, Luo Huan, Li Xiang, Han Yanquan, Chen Hao, Li Ying
    Adverse Drug Reactions Journal. 2023, 25(7): 398-404. https://doi.org/10.3760/cma.j.cn114015-20221017-00951
    To analyze the risk factors of anaphylaxis caused by sodium dimercaptopropane sulfonate (DMPS) in patients with hepatolenticular degeneration (HLD) and its predictive value. Methods The electronic medical records of patients who were hospitalized for the first time in the First Affiliated Hospital of Anhui University of Chinese Medicine due to HLD from January 2019 to December 2021 and received DMPS treatment were collected. The basic information, relevant laboratory test results before the application of DMPS, daily dose of DMPS, and occurrence, treatment and outcome of allergic reactions in patients were recorded. The patients were divided into allergy group and control group based on whether DMPS-related anaphylaxis occurred. The clinical characteristics in patients in the 2 groups were compared. The risk factors of DMPS-induced anaphylaxis were analyzed using binary logistic regression, and the odds ratio (OR) and its 95% confidence interval (CI) were calculated. All independent risk factors were merged into joint predictor and the predictive value of individual risk factors and joint predictor for risk of anaphylaxis were analyzed using receiver operating characteristic (ROC) curve. Results A total of 477 patients were enrolled in the study, including 124 patients in the allergy group and 353 patients in the control group. Among the 124 patients in the allergy group, 80 were male and 44 were female, aged 1-51 years, with 55 patients <18 years of age. Among the 353 patients in the control group, 237 were male and 116 were female, aged 2-66 years, with 106 patients <18 years of age. A total of 191 times of allergic reactions occurred in patients in the allergy group, the main manifestations were pruritus (67 times, 35.1%) and drug-induced dermatitis (58 times, 30.4%). The allergic reactions occurred during the 1st to the 5th course of treatment, with 74 (59.7%) and 31 cases (25.0%) occurring in the 1st and 2nd course of treatment, respectively. DMPS was discontinued in all patients. Of them, 5 patients did not receive any intervention because of mild symptoms and the rest were treated with glucocorticoids and/or antihistamines, and the symptoms of anaphylaxis subsided. The differences in age, DMPS medication history before admission, drug allergy history, and peripheral blood lymphocyte count, ceruloplasmin, alanine aminotransferase (ALT), aspartate aminotrans- ferase, alkaline phosphatase (ALP), γ-glutamyltransferase, lactate dehydrogenase, and blood urea nitrogen levels before DMPS application between the 2 groups were statistically significant (all P<0.05). Binary logistic regression analysis showed that the history of drug allergy (OR=3.698, 95%CI: 2.233-6.124, P<0.001), the level of ALT before medication (OR=1.004, 95%CI: 1.000-1.007, P=0.044) and the level of ALP before medication (OR=1.003, 95%CI: 1.002-1.005, P<0.001) were independent risk factors for allergic reactions caused by DMPS in HLD patients. ROC curve analysis showed that the area under the curve (AUC) of ALT level before medication was 0.613 (95%CI: 0.553-0.673), the cutoff value was 50-U/L, the sensitivity was 0.419, and the specificity was 0.788; the AUC of ALP level before medication was 0.600 (95%CI: 0.537- 0.663), the cutoff value was 202-U/L, the sensitivity was 0.411, and the specificity was 0.816. Allergy history, ALP and ALT levels before medication were converted into joint predictor by logistic regression model. ROC curve analysis showed that the AUC of joint predictor was 0.703 (95%CI: 0.648-0.757), the cutoff value was 0.465, the sensitivity was 0.685, and the specificity was 0.657. Conclusions The history of drug allergy, the level of ALT and ALP before medication are independent risk factors of anaphylaxis induced by DMPS in HLD patients. The joint predictor has good predictive value for anaphylaxis induced by DMPS in HLD patients.
  • Chen Shidi, Jia Ke, Liu Fang
    Adverse Drug Reactions Journal. 2024, 26(10): 633-635. https://doi.org/10.3760/cma.j.cn114015-20240115-00028
    A 62-year-old male patient received antiplatelet aggregation, lipid-lowering and hypoglycemic therapy due to cerebral infarction complicated with hypertension and diabetes.After 9 days, linagliptin (5 mg orally once daily) and ertugliflozin (5 mg orally once daily) were added due to the poor blood glucose control. The next day after taking the 2 drugs, he developed a scattered rash on the chest, which gradually worsened. A large number of circular target-like erythema appeared on the trunk andproximal limbs, accompanied by pain but no obvious itching. On the 8th day after taking the 2 drugs, the dermatologist consulted and the patient was diagnosed with drug-induced rash, which was considered to be induced by linagliptin. Then linagliptin and ertugliflozin were discontinued. The patient received intravenous infusion of methylprednisolone 40 mg once daily, along with symptomatic treatments such as antihistamines. On the 4th day of treatments, the rash on his chest and back merged into a large area, accompanied by significant flaking; the dosage of methylprednisolone was increased to 80 mg by intravenous injection once daily. On the 7th day of treatments, the rash slightly subsided, and the dosage of methylprednisolone was reduced to 60 mg by intravenous injection once daily. On the 10th day of treatments, the rash was improved significantly. Corticosteroids and antihistamines were gradually discontinued. At a two-week follow-up, the patient′s rash disappeared.
  • Pan Yunyan, Li Jia, Chen Qifeng, Chen Meiling, Xia Yanzhe, Chen Pan, Chen Jie
    Adverse Drug Reactions Journal. 2023, 25(2): 95-100. https://doi.org/10.3760/cma.j.cn114015-20220512-00422
    Objective To investigate the occurrence and risk factors of intravenous polymyxin B-associated acute kidney injury (AKI) in patients with severe infection. Methods Electronic medical records of patients with severe infection treated with intravenous polymyxin B during hospitalization in the First Affiliated Hospital, Sun Yat-sen University from October 2017 to October 2020 were collected and analyzed retrospectively. Patients with polymyxin B-induced acute kidney injury were screened out. The occurrence time, clinical stage, and outcome of AKI were statistically analyzed, and the incidence of polymyxin B-induced AKI and the cumulative incidence of AKI on the 3rd, 6th, 12th, and 15th days of administration were calculated. Patients were divided into AKI and non-AKI groups according to whether polymyxin B-associated AKI occurred. The clinical characteristics in patients of the 2 groups were compared. The risk factors of AKI were analyzed by multivariate logistic regression, and the odds ratio (OR) and 95% confidence interval (CI) were calculated. Results A total of 311 patients were entered in the analysis, including 237 males (76.2%) and 74 (23.8%) females, with a median age of 58 (46, 70) years. Fifty-two patients (16.7%) developed polymyxin B-associated AKI, and the time from medication to onset of AKI was (4±2) days, ranging from 2 to 13 days. The cumulative incidence (%) of AKI and its 95%CI on the 3rd, 6th, 12th, and 15th days of polymyxin B administration were 9.1(3.0-19.4), 15.4(7.9-25.2), 21.5(12.8-31.6), and 21.5(12.8-31.6), respectively. After developing AKI, polymyxin B was discontinued in 17 of 52 patients (32.7%), and 7 of them were given continuous renal replacement therapy (CRRT). The other 35 patients (53.8%) needed to continue medication because of the infection condition, and 25 of them were given CRRT and 10 received diuretics additionally. After the above treatments, 22 (42.3%) of 52 patients had Scr returning to normal, 6 patients (11.5%) were improved, 15 (28.9%) died due to primary diseases, and 9 (17.3%) were discharged under their own request. Multivariate logistic regression analysis showed that daily dose ≥150.0-mg (OR=5.588, 95%CI: 2.258-13.833, P<0.001) and high acute physiology and chronic health evaluation Ⅱ(APACHE-Ⅱ) score (OR=1.063, 95%CI: 1.021-1.106, P=0.003) were independent risk factors for polymyxin B-associated AKI. Conclusions AKI may occur in a short time in patients with severe infection after intravenous administration of polymyxin B. The daily dose of polymyxin B ≥150.0-mg and high APACHE-Ⅱscore may increase the risk of AKI. 
  • Adverse Drug Reactions Journal. 2023, 25(1): 1-1. https://doi.org/10.3760/cma.j.cn114015-20221227-01188
  • 病例报告
    Chen Haiyan;Zou Chuanxin;Yao Yonggang
    . 2008, 10(4): 0-0.
    A 44yearold man with ulcerative colitis was treated with oral olsalazine. The dosage of olsalazine initially was 0.5 g twice daily, and subsequently was gradually increased to 1.0 g thrice daily. One month later, the man presented with fatigue and anorexia. His liver function tests showed the following: ALT 320 U/L,AST 248 U/L,γ-GT 290 U/L,ALP 108.7 U/L. Serologic tests for hepatitis A, B, C, and E were negative. Olsalazine was withdrawn immediately, and he was given oral glucurolactone and IV diammonium glycyrrhizinate. After half a month, his liver function normalized except AST (68 U/L).
  • 不良事件
    . 2002, 4(5): 346-346.
  • Tian Huichun, Zeng Han
    ObjectiveTo explore the clinical characteristics, prevention, and treatment of esophageal injury caused by dabigatran.MethodsThe databases of PubMed, Wan Fang, CNKI, and VIP were searched, and the literature of esophageal injury induced by dabigatran was collected by the end of 2017, and the relevant data were obtained for descriptive analysis.ResultsThe study comprised 12 literature on esophageal injury caused by dabigatran in total, including 1 clinical retrospective study and 11 case reports. The 12 articles included 32 patients with esophageal injury caused by dabigatran, including 22 males (68.8%) and 10 females (31.2%), aged 58-90 years, and of whom 28 patients (87.6%) were from Japan, 1 from the United States, 1 from Germany, 1 from New Zealand and 1 from the United Kingdom. Eleven patients (34.4%) had previous history of digestive system diseases. Of the 32 patients, 25 patients (78.1%) had clinical symptoms, including chest pain (7 cases), odynophagia (6 cases), dysphagia (6 cases), heartburn in the chest or stomach (6 cases), epigastralgia (4 cases) and hemorrhage (4 cases). Endoscopic findings were mainly esophageal mucosal exfoliation (28 cases) and ulceration (8 cases). The esophageal injuries mostly occurred in the middle lower part of the esophagus. Esophagus injury was not related to the duration and dosage of dabigatran therapy, but it might be related to an incorrect drug use. Five patients with mild esophageal injury did not stop using dabigatran and their symptoms improved with a corrected way of taking medicine. However, in severe cases, dabigatran should be stoped. The patients might take other anticoagulants, use proton pump inhibitors, and should have a restrictive diet, and then the injury of the esophagus was gradually improved. ConclusionsDabigatran might cause esophagus injury and it mainly manifested as esophageal mucosal exfoliation and ulceration, whose prognosis was better in general. Therefore, the guidance on the correct use of dabigatran for the patients should be strengthened to prevent esophageal injury occurring.
  • Liu Ying, Zhang Xian, Li Pengmei
    Adverse Drug Reactions Journal. 2020, 22(1): 52-53. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.01.014
    A 3-day-old newborn received an IV infusion of cefepime 0.16 g dissolved in 5% glucose injection 100-ml once per 12-hours for infectious jaundice. On the 6th day, the infant developed skin redness on the left lateral canthus, neck, and armpits. Erosion and large pieces of epidermal detachment occurred on the armpit skin. The area of skin exfoliation was about 2-cm×2.5-cm. It was considered to be exfoliative dermatitis induced by cefepime. Cefepime was discontinued, berberine was dissolved in water for bathing, and erythromycin ointment was used externally. Three days later, the skin erosions improved markedly, no new skin exfoliation occurred, jaundice subsided obviously. At 1 month of follow-up, the jaundice completely disappeared and the skin lesion healed.
  • Pei Yuying, Li Nuo, Jia Liqun, Lou Yanni
    Adverse Drug Reactions Journal. 2020, 22(8): 481-483. https://doi.org/10.3760/cma.j.cn114015-20190403-00339
    Two patients (patient 1, a 60-year-old female; patient 2, a 62-year-old male) received oral targeted drug crizotinib (250-mg twice daily and 500-mg once daily, respectively) for anaplastic lymphoma kinase-positive non-small cell lung cancer. Both patients developed skin reactions of their hands after half a year of treatment, which were aggravated as the treatment continued. Symptoms of patient 1 presented as large red patches on the hands, forearms, and neck, with mild epidermis hypertrophy and desquamination, accompanied by obvious tenderness. Symptoms of patient 2 presented as chapped, ulcerated, and erosive skin on the fingertips and palms, accompanied by obvious pain. The 2 patients were given soaking treatment with compound granules of traditional Chinese medicine consisting of raw Astragalus, Carthamus, Radix Arnebiae, Geranium, and Radix Angelicae Sinensis, and their symptoms were obviously improved after 4 and 5 weeks, respectively.
  • Yang Ling
    . 2015, 17(4): 299.
    Two male children (aged 11 and 7 years, respectively) received intramuscular injections of procaine benzylpenicillin 650 000 U and 600 000 U twice daily for streptococcal infection syndrome and acute tonsillitis, respectively. Convulsions, unconsciousness, facial cyanosis, upward deviation of the eyes appeared after the tenth and the third intramuscular injections, respectively. Intramuscular injections of dexamethasone 5 mg and oxygen inhalation through nasal tube were given immediately and the symptoms were improved within 1 min. No positive signs were found on the physical examinations and no abnormal findings were detected by brain CT, EEG and blood biochemical tests. Both patients recovered after treatment with other antimicrobial drugs and the convulsion did not occur at 1 year of follow-up.
  • Zhang Yuqin, Wang Lan, Zhang Bo
    . 2016, 18(1): 70.
    A 60-year-old male with Parkinson′s disease for one year suddenly stopped using levodopa (0.25 g,twice daily) by himself. About 3 weeks later, he developed the symptoms of ardent fever, inarticulacy, confusion, increased heart rate (130-138 beats/min), shortness of breath, delirium, aggressive behavior, hypermyotonia, drowsiness, increased tremble, and decreased cognitive ability successively. The results of laboratory test showed increased white blood cell count (16×109/L-28×109/L). The patient agreed to resume taking levodopa (0.25 g, twice daily) about 4 weeks after drug withdrawal by conversations with his family member repeatedly. The patient′s mental ability and muscle tension of limbs returned to normal on day 4 of medication again. The symptom of delirium did not appear and the symptoms of Parkinson′s disease were relieved.
  • Sun Jiyun, Ma Xiaoyan, Cai Haodong
    . 2017, 19(2): 109-112.
    ObjectiveEffects of long-term use of tenofovir on kidney and skeletal muscle related laboratory indexes in patients with chronic hepatitis B.MethodsThe medical record data of patients with chronic hepatitis B in Beijing Ditan Hospital, Capital Medical University from January 1, 2014 to December 31, 2014 were collected and retrospectively analyzed. All patients were given tenofovir 300 mg once daily and lasted for 24 months. The levels of serum creatinine, phosphorus, alkaline phosphates (ALP) and creatine kinase (CK) were tested before medication and 3, 6, 9, 12, 15, 18, and 24 months after medication. The laboratory tests suggestive of adverse events included the following: values of serum creatinine exceeding the baseline value by 44.2 μmol/L, blood phosphorus<0.8 mmol/L for 2 consecutive times (every 3 months), serum ALP>2 times more than the upper limit of normal (ULN) and,serum CK>3 times more than ULN or CK>500 U/L for 2 consecutive times (every 3 months).ResultsA total of 40 patients were enrolled in this study, including 31 males and 9 females, with a mean age of 34±11 years (19-59 years). After medication, the serum creatinine levels of all patients gradually increased, but only the trend of male patients was statistically significant (P=0.03). There was no statistically significant difference in serum phosphorus and CK levels between male and female patients before and after medication (P>0.05). Of the 40 patients, 1(2.5%) case was identified as a laboratory adverse event since serum phosphorus <0.80 mmol/L for 3 consecutive times. No other laboratory test results suggesting adverse events were found. ConclusionsChronic hepatitis B patients taking tenofovir for two consecutive years might cause increase of serum creatinine and decrease of blood phosphorus, therefore monitoring should be strengthened. The medication had no significant impact on serum CK levels.
  • ADR咨询
    . 2002, 4(5): 353-353.
  • 病例报告
    QIAO Zheng-gui
    . 2012, 14(2): 131-2.
    A 75-year-old woman with first degree atrioventricular block received berberine 0.3 g thrice daily as an adjuvant for control of blood sugar levels. On day 3 of treatment, she experienced palpitation. Electrocardiogram (ECG) showed sinus rhythm, second degree atrioventricular block. Oxygen inhalation was given. After thirty minutes, the above-mentioned symptoms disappeared. A repeat ECG showed sinus rhythm and first degree atrioventricular block. Berberine was stopped. One week later, the patient self-medicated with berberine again, the same symptoms recurred. One day after the drug discontinuation, her symptom disappeared.
  • ADR系列问答
    . 2010, 12(5): 376-1.
  • 安全信息
    . 2011, 13(2): 94-1.
  • 病例报告
    Li Lihua;Wei Hua;Song Xiaodan
    . 2011, 13(1): 45-1.
    Two patients, a 58-year-old man and a 49-year-old woman, received metronidazole 0.4 g thrice daily for prevention and treatment of oral infection. They presented with gross hematuria on days 2 and 3 after drug administration, respectively, followed by lumbago, urgency of urination, urinary frequency, painful urination, and other symptoms. Routine urine tests revealed RBC(++)in the male patient and numerous RBC in the female patient. Metronidazole was discontinued and switched to combination treatment with cefalexin and erythromycin ethylsuccinate. Their symptoms improved gradually and then disappeared.
  • Wang Bingsong, Wang Ting, Tao Hong, Fang Hao, Zhang Zhengyong, Luo Heping
    . 2017, 19(5): 383.
    A 3-year-old girl received phenobarbital 20 mg thrice daily for the prophylaxis of febrile seizure at the beginning of each fever. Twelve hours after the first oral administration, the patient developed red spots on her perioral skin. About 1 hour after the second oral therapy, the patient developed the same rash on her perioral skin and right upper limb. The same symptoms occurred three times in succession after each dose. About one hour after treatment with phenobarbital again, the patient developed the same rash on her perioral skin, right upper limb and bilateral buttocks. The patient was diagnosed as fixed drug eruption induced by phenobarbital. Phenobarbital was stopped and the oral diazepam 1.25 mg thrice daily was given in order to prevent febrile convulsions. All above mentioned symptoms did not recur.
  • Liu Qianxin, Zhao Nan, Xiang Qian, Zhang Zhuo, Cui Yimin
    . 2017, 19(5): 380.
    A 49-year-old female patient with breast cancer received IV infusion of gemcitabine (1.6 g) and paclitaxel (120 mg) at the day 1, 8, and 15 (the treatment course was 21 d). The routine blood test showed WBC 0.9×109/L, PLT 65×109/L, and neutrophil count 0.3×109/L. The chemotherapy regimen was changed to be given at day 1 and 8 of the treatment cycle and the treatment at day 15 was cancelled. At the 3rd week of the 2nd treatment cycle (the 35th day from treatment start), the patient developed cough and expectoration. Chest X-ray showed a small amount of bilateral pleural effusion and bilateral lung interstitial disease. It was considered that the chemotherapeutic drugs induced the interstitial pneumonia. Treatments with oxygen inhalation, eliminating phlegm and anti-inflammation were given and 13 days later, her cough and expectoration were improved. Because of granulocytic deficiency induced by chemotherapeutic drugs, the chemotherapy was suspended for 10 days and the dose of paclitaxel was changed to 90 mg. At later follow-up, the patient′s condition aggravated, but interstitial pneumonia did not recur.
  • Zhang Juan, Wu Dongyuan, Wang Yongjie, Dong Mei
    . 2018, 20(4): 313-314.
    A 39-year-old female patient with sigmoid colon and rectal adenocarcinoma received an oral regorafenib 160 mg once daily because of the disease progression. The treatment course was 21 days. The results of routine blood test showed her PLT 159×109/L before regorafenib treatment. Seven days after medication, the patient developed asthenia and gingival bleeding. Laboratory test showed PLT 38×109/L and thrombocytopenia was diagnosed. Regorafenib was stopped and infusion of platelets was given twice, 2.5 U totally. On day 7 after the drug withdrawal, the patient′s PLT restored to 159×109/L and on day 15, PLT 217×109/L. Oral regorafenib 80 mg once daily was given again. On day 10 after regorafenib treatment again, laboratory test showed PLT 69×109/L, the patient developed fistula bleeding on renal pelvis and small intestine. Regorafenib was stopped again and replaced with capecitabine. On the next day after the drug withdrawal, the bleeding disappeared. At 2 weeks of follow-up, bleeding did not recur in the patient.
  • Huang Jinlu, Wan Lili, Huo Yan, Li Jie,Yang Quanjun, Lu Jin, Gan Run, Guo Cheng
    . 2018, 20(1): 38.
    ObjectiveTo explore the status of research on global drug-induced liver injury (DILI).MethodsThe term "drug induced liver injury" was input to the search box on GoPubMed homepage. The papers related to DILI which embodied in PubMed database untill (August 22, 2017) were searched and collected. The annual publication, distribution of region (countries and cities) and situation of journal were analyzed by the statistical function of GoPubMed.ResultsA total of 27 077 papers related to DILI were collected. The results of analysis of annual publication of documents showed that the number of papers published during 1988 to 2006 was about 100 per year, the number of papers published during 2007 to 2016 was increased, there were 439 papers in 2016 and 340 papers until the retrieval time. The country which published the papers related to DILI over 250 were United States (1 142), China (770), Japan (438) and Germany (282), respectively. The cities which published the papers related to DILI greater than or equal to 50 were Beijing (112), Tokyo (91), Seoul (84), Shanghai (77), London (73), Nanjing (73), Paris (66), Madrid (56), Boston (53) and Taipei (50), respectively. The journals which published the papers related to DILI over 50 were Gastroenterologie Clinique Et Biologique (98), Hepatology (79), Lancet (72), Journal of Hepatology (61), Gastroenterology(57), Toxicology and Applied Pharmacology (57), Toxicology (54), Annals of Internal Medicine(51) Journal of Ethnopharmacology (all 51), respectively.ConclusionsThe number of papers related to DILI showed an increasing tendency. The country which published the papers related to DILI are United States, China, Japan and Germany. DILI is a global problem.
  • 不良事件
    . 2004, 6(5): 347-347.
  • 不良事件
    . 2004, 6(2): 133-133.
  • Liang Yu, Meng Zhen, Liu Donghua, Cang Huaiqin, Ji Hongyan, Yang Xue, Quan Xianghua
    Adverse Drug Reactions Journal. 2022, 24(3): 159-161. https://doi.org/10.3760/cma.j.cn114015-20210609-00656
    A 64-year-old male patient with gastric adenocarcinoma received chemotherapy with oxaliplatin (250-mg intravenous infusion on day 1) and tegafur gimeracil oteracil potassium (60-mg orally twice daily on day 1 to day 14, 21 days as a cycle). One month later, he was given nivolumab immunotherapy (240-mg intravenous infusion on day 1, 14 days as a cycle). On the 2nd day of the 4th cycle of nivolumab treatment (the 44th day after the first dose), the patient developed diarrhea with watery stools, 3 to 4 times a day, accompanied by mild abdominal pain; 3 days later, the diarrhea worsened, showing dark red bloody stools, covered with pus moss, up to 10 times a day, accompanied by obvious abdominal pain. According to colonoscopy and histological examination results, ulcerative colitis (initial onset, total colon, active stage, and severe) was diagnosed, which was considered as a grade 3 immune-related colitis induced by nivolumab. After suspension of chemotherapy and immunotherapy, and administration of glucocorticoids and octreotide, the patient′s abdominal pain and diarrhea were gradually improved. On the 45th day of nivolumab withdrawal, the patient received chemotherapy with oxaliplatin and tegafur gimeracil oteracil potassium again, and colitis did not recur.
  • Yan Xiujuan, Zhou Guangjie, Li Jinfen
    Adverse Drug Reactions Journal. 2024, 26(8): 501-503. https://doi.org/10.3760/cma.j.cn114015-20230920-00694
    A 51‑year‑old female patient with ovarian cancer was treated with 5 cycles of immunotherapy, targeted therapy, and chemotherapy (pablizumab+bevacizumab+irinotecan+cisplatin), and her disease condition was stable. After that, pabolizumab was changed to toripalimab for 2 cycles because of personal reason. Two days after the last treatments, the patient developed erythema with pruritus, and eyelid edema; 10 days later, symptoms such as dysphagia, dysarthria, and decreased muscle strength appeared. Laboratory tests showed creatine kinase 2 633 U/L, interleukin‑6 48.69 ng/L, positive anti‑TIF1‑γ antibody. Magnetic resonance imaging of limb muscles showed myositis. Electromyography showed myogenic injury of the left deltoid and tibialis anterior muscles. It was considered that the myositis was caused by toripalimab.
    After 16 days of treatments with methylprednisolone, intravenous human immunoglobulin for intravenous injection, and tocilizumab, the patient′s systemic erythema and eyelid edema basically subsided, the muscle zymogram continued to decline, but dysphagia and dysarthria still existed.

  • Li Yun, Li Bingsheng, Li Yixiu, Yuan Zhen, Xiong Aizhen
    Adverse Drug Reactions Journal. 2024, 26(3): 162-169. https://doi.org/10.3760/cma.j.cn114015-20230714-00526
    Objective To systematically evaluate the efficacy and safety of carfilzomib in treating relapsed and/or refractory multiple myeloma (RRMM) in the real world. Methods Relevant databases at home and abroad were searched (up to April 2023), and the literature on real-world studies of carfilzomib in the treatment of RRMM was collected. The quality of the literature was evaluated with the methodological index for non-randomized studies (MINORS) scale. Research data on the effectiveness and safety in RRMM patients treated with carfilzomib were extracted. The effectiveness indicators included the overall response rate (ORR), median progression-free survival (PFS), and overall survival (OS). The safety indicators included the incidence of adverse events (AEs) and the rate of treatment termination due to AEs, etc. Stata 13.0-software was used for meta-analysis of single proportions, and the occurrence of major adverse events was analyzed by descriptive statistics. Results A total of 12-studies were entered, including 2-615 patients. The quality evaluation results showed that all of the 12-studies were with high quality. The meta-analysis of single proportions showed that ORR of carfilzomib in the treatment of RRMM was 75%[95% confidence interval (CI): 68%-82%], the incidence of ≥ grade 3 AEs was 46% (95%CI: 44%-49%), and the incidence of treatment termination due to AEs was 14% (95%CI: 10%-19%). AEs with an incidence of >5% included thrombocytopenia, anemia, neutropenia, infection, hypertension, liver injury, and kidney injury. Conclusions In the real world, the efficacy of carfilzomib in the treatment of RRMM is lower than that in clinical trials. The occurrence of infection during carfilzomib treatment and drug toxicity to the hematological system, cardiovascular system, liver, and kidney need to be paid attention to.
  • Ye Xuan, You Yufang, Gao Feifei, Xu Xuan, Zhai Qing
    Adverse Drug Reactions Journal. 2023, 25(3): 172-177. https://doi.org/10.3760/cma.j.cn114015-20220615-00532
    With the widespread clinical use of immune checkpoint inhibitors (ICIs), the risk of thrombotic events has also increased, which is related to the poor survival rate. Most studies indicate that ICIs treatment may increase the risk of thrombotic events in tumor patients, but the correlation is still controversial. The incidence and risk factors of thrombotic events are various in different studies. Patients with malignant tumors of lung, skin, and genitourinary system are at high risk of thrombotic events. The clinical types of thrombotic events are mainly pulmonary embolism, myocardial infarction, and deep vein thrombosis. The mortality rate in patients with thrombotic events is high. At present, there are no guidelines or consensus on the management of thrombosis risk related to ICIs. To improve the understanding of these adverse effects in clinic, this article reviews the correlation between ICIs and thrombotic events, and the incidence, risk factors, pathogenesis, prevention, and treatment of relevant thrombotic events.
  • Wang Min, Zhang Li
    Adverse Drug Reactions Journal. 2022, 24(3): 164-166. https://doi.org/10.3760/cma.j.cn114015-20210609-00663
    A 63-year-old male patient underwent coronary CT angiography and intravenous injection of 100-ml of iopromide. About 2-minutes after finishing the examination, the patient felt chest tightness, shortness of breath, general discomfort, redness of skin, and scattered rash, followed by transient disturbance of consciousness and urinary incontinence. Two to 3-minutes later, the patient regained consciousness, and was restless; the blood pressure was 51/35-mmHg. Electrocardiogram showed ST segment elevation in leads I, AVL, and V1-V5 and increase of troponin, creatine kinase, and brain natriuretic peptide precursors. After antiallergy, antishock, fluid replacement, volume expansion, and antiplatelet treatments, electrocardiogram was normal and blood pressure was 132/78-mmHg. After retrospective analysis of cases and literature review, it was considered that the patient had Kounis syndrome resulted by iopromide-induced anaphylactic shock.
  • Tang Fengyi,Kong Wei,Shu Qing,Ge Weihong,Peng Yuzhu,Wang Hong
    Adverse Drug Reactions Journal. 2022, 24(8): 441-443. https://doi.org/10.3760/cma.j.cn114015-20220119-00053
    A 62-year-old female patient with systemic vasculitis was treated with glucocorticoid and cyclophosphamide for a long time, and then cyclosporine was added due to poor control of the disease. After more than 4 months of cyclosporine treatment, the patient developed a dark red rash on the right lower limb. Later, skin biopsy was performed and pathological examination and immunohistochemical test results suggested Kaposi′s sarcoma. No abnormality was found in the blood lymphocyte subsets count of the patient, and the immune deficiency diseases were not considered. Kaposi′s sarcoma was considered to be related to the immunosuppressive drugs. Cyclophosphamide and cyclosporine were switched to Leigongteng Duogan (雷公藤多苷) and the dose of glucocorticoid was reduced. Seven days later, the rash in the patient was improved; more than 2 months later, the rash on the patient′s right lower limb subsided and the skin was smooth without swelling.
  • Jiang Ni, Zhang Xu, Shi Xiaoping, Wang Xiaoling, Li Ying, Ji Xing
    ObjectiveTo investigate the possible risk points of medication errors in process of digoxin therapy in pediatric patients.MethodsThe doctors, nurses, pharmacists, and patients involved in process of digoxin therapy in Beijing Children′s Hospital, Capital Medical University, Dalian Children′s Hospital of Dalian Medical University, and Children′s Hospital of Nanjing Medical University were investigated by questionnaires, and the places involved were investigated on-the-spot. According to the results of questionnaires, on-the-spot investigation, and bibliographic search, the possible risk points of medication errors in process of digoxin therapy in pediatric patients were analysed using method of failure mode and effect analysis. The risk priority numbers (RPN) were calculated and sorted from high to low. The risk points with higher RPN scores were deemed to be the high frequency ones in process of digoxin therapy in pediatric patients.ResultsA total of 33 risk points were found from 4 links, including doctor prescribing, drug dispensing, nurse dispensing, and patient medication. The results of RPN sorting showed that the risk point with the highest RNP scores in doctor prescribing was special note absence for digoxin in hospital information system (67.5); the risk scores point with the highest PRN scores in drug dispensing was inaccurate dose occurred when digoxin was divided into small parts (74.7); the risk point with the highest PRN scores in nurse dispensing was that the digoxin was not kept in a dark place in ward medicine cabinet (15.2); the risk point with highest PRN scores in medication process was that the children′ guardians were not clear about the clinical manifestations of digoxin overdose(47.5).ConclusionSpecial note absence for digoxin in hospital information system, inaccurate dosage of digoxin when divided into small parts, improper storage of digoxin in the ward, and lack of knowledge about the clinical manifestations of digoxin overdose are probably the high frequency risk points of medication errors in process of digoxin therapy in pediatric patients.
  • Mao Lichao, Zhang Yue, Yan Huiyu, Li Yueyang
    Adverse Drug Reactions Journal. 2019, 21(4): 301-302. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.015
    A 32-year-old woman received IV infusion of doxorubicin hydrochloride liposomes injection 20 mg, added into 5% glucose injection 250 ml, for malignant lymphoma. About 1 minute after the initiation of the IV infusion, the patient developed facial flushing and itchy throat. Two minutes later, the patient developed sudden convulsions, loss of consciousness, binocular gaze, trismus, and urinary incontinence. Anaphylactic shock was diagnosed and the drug was discontinued immediately. Treatments such as intravenous injections of adrenaline hydrochloride injection, dexamethasone sodium phosphate injection, and methylprednisolone sodium succinate for injection, oxygen inhalation, intravenous injections of nikethamide injection, lobeline hydrochloride injection, and norepinephrine bitartrate injection, and cardiopulmonary resuscitation were given successively. However, the patient had been in a deep coma without spontaneous breathing and her blood pressure and urination needed to be maintained by drugs. On day 112 of hospitalization, cerebrovascular color ultrasound showed spectrum changes of brain death. On day 253, the patient was discharged at the request of his family members.
  • Zhou Lun
    . 2017, 19(5): 382.
    A 75-year-old male patient with multiple myeloma relapse was treated with carfilzomib 30 mg (20 mg/m2) and dexamethasone 15 mg intravenous infusion at day 1, 2, 8, 9, 15, and 16 of treatment, the treatment cycle was 28 days). Amlodipine besylate, telmisartan, amiodarone, furosemide, and spironolactone were given concomitantly with chemotherapeutic drugs. At the day 9 of the second treatment cycle, the patient developed dyspnea and orthopnea. Ultrasonography showed bilateral pleural effusion and the right side was more prominent. Chest X-ray showed massive pleural effusion in the right side and the fluid was transudate. It was considered that the pleural effusion was induced by carfilzomib. The carfilzomib was stopped, other drugs continued, and diuresis therapy were strengthened. Eleven days later, the patient′s dyspnea disappeared, and the ultrasound examination showed a little effusion in the right thoracic cavity and no effusion in the left thoracic cavity.
  • Xia Ning, Feng Zhihong, Wei Bing, Nie Xiuhong
    . 2017, 19(3): 200.
    ObjectiveTo evaluate the safety and efficacy of indacaterol in treatment of stable chronic obstructive pulmonary disease (COPD). MethodsThe related databases were electronically searched for the randomized controlled trials (RCT) on the treatment of stable COPD with indacaterol published before November 1st, 2016. The quality of the reports enrolled into the Meta-analysis was evaluated by Jadad scoring system. The Meta-analysis was conducted using Review Manager 5.3 software. The results were presented as relative risk (RR) and 95% confidence intervals (CI) .ResultsA total of 10 RCTs involving 7 315 patients were enrolled, including 4 439 in the indacaterol group and 2 876 in the placebo group. The Jadad score of all literatures was 3 to 5. They were all high quality documents. The results of Meta-analysis showed that the incidence of COPD acute exacerbation in the indacaterol group was lower than that in the placebo group, the difference was statistically significant[20.6% (914/4 439) vs. 22.4% (643/2 876), RR=0.85, 95%CI: 0.77-0.92, P<0.01]. The results of subgroup analysis showed that the incidence of COPD acute exacerbation in doses of 150 μg/d and 600 μg/d in the indacaterol group were lower than those in the  placebo group, the differences were statistically significant[(20.4% (384/1 878) vs. 22.2% (359/1 617), RR=0.84, 95%CI: 0.74-0.95, P<0.01;27.5% (117/425) vs. 34.7% (150/432), RR=0.79, 95%CI: 0.65-0.97, P=0.02)]. The incidence of severe COPD acute exacerbation in the indacaterol group was lower than that in the placebo group, the difference was statistically significant[2.3% (103/4 439) vs. 2.9% (84/2 876),RR= 0.72, 95%CI: 0.54-0.96, P=0.03]. The results of subgroup analysis showed that the incidence of severe COPD acute exacerbation at dose of 600 μg/d in the indacaterol group was lower than that in the placebo group, the difference was statistically significant[0.9% (4/425) vs. 3.9% (17/432), RR=0.24, 95%CI: 0.08-0.7, P<0.01].The overall fatality rate in the indacaterol group was lower than that in the placebo group, but the difference was no statistically significant [0.25% (8/3 164) vs. 0.58% (11/1 906), RR=0.48, 95%CI: 0.20-1.14, P=0.10]. The fatality rate due to cardiovascular events in the indacaterol group was lower than that in the placebo group, but the difference was not statistically significant [0.22% (7/3 164) vs. 0.42% (8/1 906), RR=0.56, 95%CI: 0.22-1.42, P=0.22]. The fatality rate due to respiratory diseases in the indacaterol group was lower than that in the placebo group, but the difference was no statistically significant [0.12% (2/1 668) vs. 0.20% (2/999), RR=0.65, 95%CI: 0.13-3.31, P=0.61]. The result of sensitivity analysis showed that the outcome of the study was stable and not influenced by simplex trial. ConclusionIndacaterol is effective and relatively safe of treatment in patients with stable COPD.
  • Kong Yanling, Zhang Shaobo
    . 2016, 18(4): 301.
    A 63-year-old female patient with bronchopneumonia received an IV infusion of  amoxicillin clavulanic acid potassium 1.2 g twice daily. The patient developed nausea and rectal tenesmus about 20 minutes after the start of amoxicillin clavulanic acid potassium treatment each time on the first day. No treatments were given and the symptoms relieved gradually 3 hours after finishing the IV infusion. The patient developed the above-mentioned symptoms again about 20 minutes after the start of amoxicillin clavulanic acid potassium treatment on the second day, and rectal mucosal prolapse appeared at the same time. The amoxicillin clavulanic acid potassium was stopped immediately and an IV infusion of ceftriaxone sodium 2 g once daily was given on the third day. After 3 days of ceftriaxone sodium treatment, the patient′s cough and expectoration were improved and disappeared on the 8th day, and the rectal mucosal prolapse did not recur.
  • Tang Xiaofei, Tan Bing, Zhang Yan, Liu Hongjun, Yang Meng, Chen Lijuan, Yang Zhixiang
    . 2016, 18(4): 303.
    A 79-years-old male patient took carbamazepine 100 mg thrice daily for the trigeminal neuralgia and added the dose of carbamazepine to 200 mg thrice daily by himself because the pain could not be controlled. One month later, the patient developed shortness of breath, heart palpitations, dizziness, and limbs numbness. Laboratory tests showed the following results: white blood cell (WBC) 3.0×109/L, red blood cell (RBC) 3.1×1012/L, hemoglobin (Hb) 100 g/L, serum sodium 127 mmol/L, chloride 95 mmol/L, total thyroxine 58 nmol/L, free thyroxine 10.6 pmol/L, thyroid-stimulating hormone (TSH) 4.5 mU/L. Dynamic electrocardiogram showed average heart rate 59 beats/min and 326 times of cardiac arrest exceeding 2.0 s. He was diagnosed with sick sinus syndrome and hypothyroidism. The patient was discharged after symptomatic treatments. About 3 months later, shortness of breath, dizziness and heart palpitations appeared again, accompanied by syncope 2 times (about 1 minute each time and relieved spontaneously). Laboratory tests showed the following results: WBC3.1×109/L, RBC 3.0×1012/L, Hb 99 g/L, serum sodium 127 mmol/L, chloride 95 mmol/L, total thyroxine 63 nmol/L, free thyroxine 11.8 pmol/L, TSH 7.9 mU/L. Dynamic electrocardiogram showed arrhythmia, atrioventricular block, and R-R interval prolongation. Carbamazepine was stopped. Ten days later, dizziness, heart palpitations, and syncope disappeared. The laboratory revealed the following results: WBC 5.6×109/L, RBC 4.4×1012/L, Hb 120 g/L, serum sodium 139 mmol/L, chloride 102 mmol/L, total thyroxine 67 nmol/L, free thyroxine 15.0 pmol/L, TSH 3.8 mU/L. Dynamic electrocardiogram showed sinus heart rate and heart rate 75 beats/min. Carbamazepine 100 mg thrice daily was administered again for trigeminal neuralgia. The above mentioned symptoms did not recur during a half year of follow-up.
  • . 2015, 17(5): 398.
  • 病例报告
    Shi Lijin;Gao Qin;Xu Min;Wang Guoqing;Huang Lunfeng
    . 2011, 13(1): 46-1.
    A 43-year-old woman with bronchiectasis complicated by infection received an IV infusion of ceftezole sodium 2.0 g dissolved in 0.9% sodium chloride 250 ml, followed by an IV infusion of clindamycin 1.2 g dissolved in 10% glucose 500 ml 5 hours later. About 20 minutes after the infusion started, the patient experienced abdominal pain, repeated vomiting, and gross hematuria. Clindamycin was discontinued immediately and she was given IM diclofenac sodium 50 mg and IM cimetidine 200 mg. Later, her abdominal pain alleviated. She failed to urinate 3 hours after the administration of clindamycin until the next morning, and then generalized edema occurred. Renal function tests showed the following values: blood urea nitrogen 17.6 mmol/L, serum creatinine 544 μmol/L. She was diagnosed with clindamycininduced acute renal failure. On days 3 and 6 after admission she received hemodialysis, and then her urine output gradually returned to normal range. Her blood urea nitrogen and serum creatinine levels were 4.3 mmol/L and 65 μmol/L, respectively. After administration of an infusion of ceftezole sodium 2.0 g/d for treatment infection, the patient’s symptom of cough was relieved and purulent sputum disappeared. On day 7, she was discharged.
  • 安全信息
    . 2007, 9(6): 449-449.
  • 安全信息
    . 2010, 12(6): 447-1.
  • 病例报告
    WU San-lan;CHEN Dong-sheng
    . 2012, 14(3): 181-2.

    A 50-year-old man received an intravenous infusion of amiodarone 150 mg via a pump for arrhythmia. About 5 minutes after infusion initiation, the patient developed an electric shock-like lower back pain and pallor. The infusion was stopped immediately and, about 15 minutes after drug discontinuation, his symptoms completely relieved. Ten minutes after remission, an IV infusion of amiodarone via a pump was readministered and, about 3 minutes later, an electric shock-like lower back pain recurred. The infusion was stopped immediately. About 5 minutes later, his back pain vanished entirely.

  • 安全信息
    . 2012, 14(1): 38-1.
  • 病例报告
    SANG Jian-feng;WANG Xue-chen
    . 2012, 14(4): 243-2.
    A female patient aged 60 took tiopronine 0.2 g thrice daily by mouth for mild abnormal liver function. About 20 days later, the patient developed suddenly chill and fever with a peak temperature of 39.3℃ ten minutes after tiopronine administration. Cefuroxime, azithromycin, moxifloxacin, and other medications were given at a local hospital, but tiopronine was not withdrawn. Her symptoms did not improve and dry cough, short of breath with activity, pulmonary edema, and pleural effusion appeared. The patient then was admitted to our hospital. After admission, the patient still received anti-infective treatment, and she stopped tiopronine by herself. The next day, her temperature returned to within normal range and, four days later, all her symptoms relieved and she was discharged. Two days after discharge, hyperthermia and chill recurred ten minutes more after starting self-medication with tiopronine 0.2 g and her symptoms subsided after drug discontinuation and receiving antipyretic treatment.
  • Long Liang, Lei Haibo, Li Ronghui, Li Wei
    . 2016, 18(3): 224.
    An 85-year-old female underwent pulmonary CT enhancement scan. Two hours after receiving an IV infusion of iopamidol 54 ml, she presented with unequal size of blisters on trunk,  head and neck. Thirteen hours after receiving iopamidol, she developed fever and vomiting. The patient was diagnosed as epidermolysis bullosa type eruption due to iopamidol by a dermatologist. She received symptomatic treatment including methylprednisolone and sodium thiosulfate for antianaphylaxis and anti-infective agent immediately. Twenty-two days later, the exfoliation occurred, there was rubefaction on the basal surface of  blister. The surface of  wound healed basically.
  • Sun Zhenxiao, Li Jingjun
    . 2016, 18(3): 230.
    A 72-year-old man with depression received oral olanzapine 7.5 mg/d and fluvoxamine 125 mg/d. Two months after the drug administration, the patient developed fever, consciousness, rigidity, sweating, and tachycardia. Blood tests showed that the white blood cell count was 12.3×109/L and creatine kinase (CK) level was 737 U/L. All drugs were stopped and continuous oxygen inhalation, electrocardiographic monitoring and measures for keeping the respiratory tract unobstructed were given. Ice pillows and ice packs were used to lower his temperature. Treatments such as fluid infusion, correction of water-electrolyte balance, infection prevention, intravenous infusion of clonazepam 1 mg once daily, and oral dopamine receptor agonist piribedil 100 mg once daily were also given. Three days later, his temperature returned to normal and his consciousness turned clear. Five days later, his muscle tension, routine blood test, and CK level returned to normal.
  • Xiao Hongmei, Xiao Yiwen, Xu Ping
    . 2016, 18(5): 383.
    A 63-year-old female with postherpetic neuralgia received ibuprofen sustained release capsules 0.3 g twice daily. On day twelve after medication, the patient developed papula, erythema accompanied by pruritus on her body and arms and legs. On day seventeen, the oedema occurred on her face. On day twenty, she had high fever. Laboratory tests revealed the following results:white blood cell (WBC) 26×109/L, neutrophile granulocyte  0.46, eosinophils 0, C-reactive protein (CRP) 38.6 mg/L, procalcitonin (PCT) 16.46 μg/L, alanine aminotransferase (ALT) 329 U/L, aspartate aminotransferase (AST) 291U/L, lactate dehydrogenase (LDH) 1 089 U/L, creatine kinase isoenzyme (CK-MB) 35 U/L, and myoglobin (MYO)116 μg/L. She was diagnosed as drug-induced hypersensitivity syndrome due to ibuprofen sustained release capsules.  Ibuprofen sustained release capsules was stopped. The patient received the treatment including IV infusion of methylprednisolone, compound glycyrrhizin injection, sodium thiosulfate, immunoglobulin,  oral administration of desloratadine tablets and  levocetirizine hydrochloride tablets, and external application of desonide cream. On day 13 of drug withdrawal,  her facial oedema was subside largely, the color of erythema changed to dark,  and erythra decreased  obviously. Laboratory tests revealed the following results: WBC 15×109/L, neutrophile granulocyte  0.5, eosinophils 0.04, CRP 7.6 mg/L, PCT 0.92 μg/L, ALT 239 U/L, AST 61 U/L, LDH 393 U/L, CK-MB 20 U/L, MYO 42 μg/L. On day 56 of drug withdrawal, the patient′s erythema was disappeared completely and the skin color was normal basically. Laboratory tests revealed the following results: ALT 63 U/L, AST 36 U/L, LDH 98 U/L, CK-MB 12 U/L, MYO 25 μg/L.
  • Liu Gaohui, Wu Yougen, Long Jianjun, Feng Naiwei
    . 2016, 18(6): 471.
    An 80-year-old male with chronic obstructive pulmonary disease acute exacerbation received oral amitriptyline 25 mg twice daily for insomnia and dreaminess. After 5 days, the sleep disorder was not improved, and he developed hallucination and phonism. Estazolam was given 1 mg orally every night. After 2 weeks, he still had dreaminess and exciting in the nights. Estazolam was added to 2 mg every night. Two days later, the patient developed somnolence. Laboratory test showed the levels of glucose and blood potassium were 6.2 mmol/L and 6.59 mmol/L. About one hour later, the patient developed sudden respiratory and cardiac arrest. He was given external-chest cardiac compression, intravenous injection of nikethamide and epinephrine. About 20 minutes later, the patient ultimately died despite resuscitation efforts.
  • Pang Peishan
    . 2017, 19(5): 390.
    A 93-year-old patient with Parkinson′s disease and Alzheimer disease received oral levodopa and benserazide hydrochlo-ride 375 mg/d, benzhexol hydrochloride 2 mg/d, donepezil hydro-chloride 5 mg/d, olanzapine 2.5-5.0 mg/d. The patient occasionally felt lower extremities weakness during the medication period. After having olanzapine two and a half years, laboratory examination showed the following levels: lactate dehydrogenase 351 U/L, creatine kinase 1 425 U/L, serum creatine 259 μmol/L. Rhabdomyolysis induced by olanzapine could not be excluded. Olanzapine was stopped. The treatments with an IV infusion of vitamin B6 50 mg dissolved in 0.9% sodium chloride injection 500 ml once daily and oral sodium bicarbonate 0.5 g thrice daily were given. On day 8, the patient′s lactate dehydrogenase level was 326 U/L, creatine kinase level was 355 U/L, serum creatine level was 63 μmol/L.
  • Chen Fan
    . 2017, 19(5): 385.
    A 23-year-old man with acute gastritis received an IV infusion of metoclopramide hydrochloride 10 mg. About 5 minutes after metoclopramide hydrochloride infusion started, he developed stress and fear, restlessness, akathisia, muscle spasm in extremities, cyanosis of limb skin, pale complexion and pale nail bed, and breathing difficulties. His blood pressure was 161/80 mmHg and heart rate was 101 beats/min. Oxygen inhalation at 10 L/min, intramuscular injections of dexamethasone 5 mg and diphenhy-dramine 25 mg and an IV infusion of dexamethasone 5 mg dissolved in 0.9% sodium chloride 500 ml were given. About one hour later, his restlessness, fear, muscle spasm and cyanosis gradually improved. Because of vomiting, an IV infusion of omeprazole 40 mg and 0.9% sodium chloride 500 ml was given. The vomiting and neuropsychiatric symptoms disappeared 3 hours later.
  • Yu Chunxia, Xu Xinyan, Li Shuchan, Sun Xianyong, Zhang Jie
    Two patients with hypertension (patient 1, female, aged 48 years;patient 2, male, aged 37 years) developed binocular vision blur 17 and 14 days after taking indapamide tablets (2.5 mg/d), respectively. Slit-lamp examination showed shallow binoculus anterior chamber. Ultrasound biomicroscopy showed binocular ciliary body detachment. Ophthalmic ultrasonic examination showed mild thickening of choroid in both eyes. The binocular ciliary body detachment and transient refraction were considered to be related to indapamide. Three days after indapamide withdrawal and receiving hormonotherapy, the 2 patients′ binocular ciliary bodies were resetted, anterior chamber depth returned to normal, and the visions returned to the premorbid state.
  • WHO信息
    . 2004, 6(6): 422-422.
  • 安全信息
    . 2006, 8(4): 308-308.
  • Wang Dongxue, Xu Feng, Hou Jiqiu
    Adverse Drug Reactions Journal. 2022, 24(1): 46-48. https://doi.org/10.3760/cma.j.cn114015-20210322-00342
    A 32-year-old female patient received anti-virus treatment with tenofovir alafenamide one month after regular hemodialysis due to stage 5 chronic kidney disease complicated with chronic hepatitis B. At the same time, recombinant human erythropoietin injection and iron sucrose injection was periodically used to correct anemia. Her hemoglobin was about 96-g/L without clinical manifestations of anemia such as nausea and fatigue. Eight months after tenofovir alafenamide treatment, she developed dizziness, headache, nausea, fatigue, and lethargy. Laboratory tests showed hemoglobin 94-g/L and serum creatinine 856-μmol/L; blood gas analysis showed pH 7.05, lactate 3.3-mmol/L, arterial partial pressure of oxygen 80-mmHg, arterial partial pressure of carbon dioxide 23-mmHg, base excess -7.4-mmol/L, and bicarbonate 15.6-mmol/L. It was considered that the patient had lactic acidosis, which might be associated with tenofovir alafenamide. The drug was stopped and replaced by entecavir and symptomatic treatments such as fluid rehydration and liver protection were given. One day later, symptoms of dizziness and headache, etc. in the patient were improved and blood gas analysis showed pH 7.25, lactate 2.9-mmol/L, base excess -3.0-mmol/L; 5 days later, the above symptoms basically disappeared and blood gas analysis showed pH 7.45, lactate 1.5-mmol/L, base excess -2.0-mmol/L.
  • Wang Jin, Zhang Lan, Hu Chaoying
    Adverse Drug Reactions Journal. 2023, 25(9): 521-526. https://doi.org/10.3760/cma.j.cn114015-20221207-01132
    Objective To explore the occurrence of rashes in healthy subjects caused by efavirenz in drug clinical trials. Methods The occurrence of rashes related to efavirenz, which was used as an enzyme inducer, in healthy subjects in 2 clinical trials conducted by the Phase I Clinical Research Center of the Department of Pharmacy, Xuanwu Hospital, Capital Medical University (our hospital) in November 2020 and October 2021 was retrospectively analyzed. The relevant databases at home and abroad (up to November 30, 2022) were searched, and the literature, in which efavirenz was applied as trial drug or enzyme inducer in healthy subjects, were collected. The cases of efavirenz-related rashes reported in the literature were reviewed. The clinical characteristics of the cases in the literature and above 2 clinical trials in our hospital were summarized and analyzed by descriptive statistics. Results A total of 40-healthy subjects were included in the 2 clinical trials, and 5 (12.5%) developed efavirenz-related rashes. The average time from taking the medicine to the appearance of rashes was 8 days. The initial symptom was skin itching. The rashes occurred mainly on the limbs and back, and mainly presented as maculopapular rashes, without other symptoms or laboratory abnormalities. Four subjects withdrew from the trial and the rashes subsided after 5-7 days of anti-allergic and symptomatic treatments; one subject was given calamine lotion for external use because of mild rashes, and continued to participate in the trial. His rashes subsided 17 days later (5 days after stopping efavirenz). Eighteen literature in which efavirenz was used as a trial drug or enzyme inducer in healthy subjects were retrieved. A total of 403-healthy subjects collected from 18 literature and our trials were included in the analysis. Of them, 19-subjects developed rashes, with a incidence of 4.7%. According to the daily dose of efavirenz, the incidence of rashes in the subjects of the 600-mg/d group was higher than that of the <600-mg/d group, but the difference was not statistically significant [5.5% (18/329) vs. 1.4% (1/74), P=0.131]. According to the course of drug, the incidence of rashes was similar in subjects between the single dose group and the continuous dose group [4.1% (4/97) vs. 4.9% (15/306), P=0.753]. Conclusion Rashes are common adverse reactions in healthy subjects after taking efavirenz, which is generally mild and can subside after timely detection and treatment.
  • Yang Yanni, Li Shuxia, Zhang Xiaojuan, Jin Weijun, Chen Minghao
    Adverse Drug Reactions Journal. 2024, 26(4): 229-233. https://doi.org/10.3760/cma.j.cn114015-20231229-00949
    Objective To actively monitor and analyze the safety of levofloxacin and sodium chloride injection produced by Guangzhou Green Cross Pharmaceutical Co., Ltd (generic drug). and levofloxacin and sodium chloride injection produced by Daiichi Sankyo (Beijing) Pharmaceutical Co., Ltd (original drug). Methods The data in this study came from the adverse drug reaction reports on levofloxacin and sodium chloride injection voluntarily monitored and reported to the National Adverse Drug Reaction Monitoring System Database by the First Affiliated Hospital of Sun Yat-sen University, Guangdong Provincial People′s Hospital, and the First Affiliated Hospital of Ji'nan University from October 1, 2022, to September 30, 2023. The information on patients′ age, gender, medication use, primary disease, time from medication to the occurrence of adverse reactions, clinical manifestations, treatment and prognosis of adverse reactions, and the occurrence of serious adverse reactions were collected. The incidence of adverse reactions was calculated. Results A total of 30 adverse reaction reports involving levofloxacin and sodium chloride injection were collected, involving 30 patients. In the generic drug group, there were 21 cases, including 8 males and 13 females, aged from 20 to 91 years with a median age of 43 years; 2 cases of serious adverse reactions were reported. In the original drug group, there were 9 cases, including 3 males and 6 females, aged from 20 to 96 years with a median age of 56 years; no serious adverse reactions were reported. In the generic drug group, a total of 36 adverse reactions occurred in 21 patients, while in the original drug group, a total of 13 adverse reactions occurred in 9 patients. These adverse reactions involved the skin and appendages, digestive system, nervous system, musculoskeletal system, urinary system, and medication site, with skin itching and rash being the most common allergic reactions (15 case time in the generic drug group, accounting for 41.7%; 6 case time in the original drug group, accounting for 46.2%). Two cases of serious adverse reactions occurred in the generic drug group, and both were anaphylactic shock. After discontinuation of the drug, switching to other antibiotics, and symptomatic treatments, 5 cases in the generic drug group were cured, 15 cases were improved, and 1 case was unknown. In the original research drug group, 2 cases were cured and 7 cases were improved. There were no deaths in either the generic or original drug groups. The incidence of adverse reactions in outpatients and/or inpatients in the generic drug group was 0.07% (21/29 557), while that in the original research drug group was 0.08% (9/10 686). There was no statistically significant difference between the 2 groups (χ2=0.183, P=0.669). Conclusion The results of active monitoring show that there is no significant difference in safety between the generic and original drugs of levofloxacin and sodium chloride injection.
  • Liu Hui, Liu Yan, Liu Yuan
    Adverse Drug Reactions Journal. 2021, 23(7): 365-369. https://doi.org/10.3760/cma.j.cn114015-20210329-10375
    Objective To explore the clinical characteristics of type 1 diabetes mellitus (T1DM) related to nivolumab (NIVO). Methods Databases including CNKI, Wanfang, VIP, PubMed, Web of Science, and Embase were searched as of December 31, 2020 and case reports on T1DM related to NIVO were collected. The patients′ information including general situation, primary disease, NIVO use, and occurrence, treatment, and outcome of T1DM, etc. were extracted and analyzed by descriptive statistical method. Results A total of 18 patients with NIVO-related T1DM reported in 17 literature were collected, including 9 males and 9 females, aged from 49 to 84 years with an average age of 69 years. The primary diseases were malignant melanoma in 8 patients, non-small cell lung cancer in 6 patients, renal cell carcinoma in 3 patients, and prostate cancer in 1 patient. Sixteen patients were treated with NIVO alone and 2 patients were treated with NIVO combined with ipilimumab. The time from NIVO treatment to diagnosis of T1DM was 34-841 days in 18 patients (<100 days in 7 patients, 100-300 days in 6 patients, and >300 days in 5 patients). Of the 18 patients, 13 (72.2%) developed fulminant T1DM and 11 (61.1%) developed diabetic ketoacidosis (DKA). The main clinical manifestations included fatigue, polyuria, polydipsia, thirst, etc., and delirium or drowsiness could also occur. One case had no clinical symptoms. Laboratory tests showed that the blood glucose levels increased obviously (17.4-52.8-mmol/L) in all 18 patients; 17 patients had HbA1c examination records, among which 16-had elevated level (by 6.5%-13.4%); 14 patients had serum C-peptide test record and the levels were all lower than the lower limit of reference value. After T1DM occurrence, 18 patients were all treated with insulin and other symptomatic treatments; NIVO was stopped in 12 patients (ipilimumab was stopped in 2 patients at the same time) and blood glucose levels returned to normal in 7 patients and were not described in 5 patients; NIVO was not stopped in 4 patients and the blood glucose levels returned to normal in 2 patients and were not recorded in 2 patients. Among the 12 patients who stopped using NIVO, 3 died of tumor progression. Conclusions NIVO-related T1DM mostly occur within 300 days after medication. The clinical manifestations are similar to those of common T1DM. The proportion of fulminant T1DM and DKA are relatively high. The blood glucose levels in most patients can be controlled after stopping NIVO and receiving insulin and other symptomatic treatments.
  • 不良事件
    . 2003, 5(3): 199-199.
  • ADR咨询
    . 1999, 1(3): 167-167.
  • Zhao Zinan, Liang Liang, Sun Xuelin, Zhu Yuanchao, Feng Yufei, Zhang Yatong
    ObjectiveTo systematically evaluate the correlation between sodium-glucose co-tran-sporter 2 (SGLT2) inhibitors and fracture risk in type 2 diabetes mellitus (T2DM) patients.MethodsThe related databases were searched. The randomized controlled trials (RCTs) which the outcome index included fracture in T2DM patients treated with SGLT2 inhibitors from the inception to August 2017 were enrolled into the study. The documents were selected according to the inclusion and exclusion criteria. After the data extraction and evaluation of methodological quality of RCTs, Meta-analysis was conducted using Rev Man 5.3 software.ResultsA total of 12 RCTs involving 28 181 patients were entered, including 17 747 patients in the test group (SGLT2 inhibitors) and 10 434 in the control group. The drugs used in the test group were canagliflozin (7 RCTs) and empagliflozin (5 RCTs). The drugs used in the control group were non-SGLT2 inhibitors including metformin, glimetazide and/or placebo. The results of Meta-analysis showed that the incidence of fractures in the test group was significantly higher than that in the control group[5.05% (897/17 747) vs. 4.40% (459/10 434), RR=1.27, 95%CI: 1.14-1.42, P<0.01]. Subgroup analysis showed that the incidence of fractures in the canagliflozin group was significantly higher than that in the control group [6.21% (679/10 938) vs. 5.28% (365/6 913), RR=1.31, 95%CI: 1.15-1.48, P<0.01]. There were no significant differences in the incidence of fractures between the empagliflozin group and the control group [3.20% (218/6 809) vs. 2.67% (94/3 521), RR=1.44, 95%CI: 0.35-5.90, P=0.61].ConclusionsCanagliflozin (a kind of SGLT2 inhibitors) can increase the incidence of fractures. It is suggested that the risk assessment should be done before medication for the benefit of patients.
  • Wu Hongmei
    Adverse Drug Reactions Journal. 2021, 23(4): 169-171. https://doi.org/10.3760/cma.j.cn114015-20210330-00388
    The elderly are susceptible to nephrotoxic drugs and at high risk of drug-induced kidney injury (DIKI) because of age-related special renal physiological changes, and usual coexistence of with multiple diseases and multiple drugs. At present, there is no effective treatment for DIKI, so prevention is very  important. Recent studies suggest that the risk factors closely related to DIKI include drug factors, patient factors and kidney factors. Comprehensive assessment of the above risk factors is helpful for early identification of elderly patients with high-risk for DIKI and timely accurate prevention.
  • Wang Wenjuan, Zheng Junfu, Ding Huiguo
    . 2017, 19(3): 228.
    A 62-year-old female with hepatitis C and decompensated cirrhosis received oral sofosbuvir 400 mg and daclatasvir 60 mg once daily. She developed edema of lower extremities about 18 weeks after beginning antiviral drugs. Two weeks later, the patient developed edema of face. Laboratory tests revealed the following results: serum creatinine 91 μmol/L, eGFR 54 ml/(min·1.73 m2), serum β2 microglobulin 4.42 mg/L, 24-hour urine protein 0.394 g. She received treatments including diuretic and liver protection. Sofosbuvir and daclatasvir was continued at the same dose as before. Eight days later, the edema of the face and lower extremities were further aggravated with decreased urine volume. Serum creatinine increased to 124 μmol/L, eGFR decreased to 37 ml/(min·1.73 m2), and serum β2 microglobulin was 5.06 mg/L. She received an IV infusions of human albumin. Two weeks later, the serum creatinine increased to 220 μmol/L, eGFR decreased to 19 ml/(min·1.73 m2), and 24-hour urine protein was 0.417 g. Acute kidney injury was diagnosed. Sofosbuvir and daclatasvir were withdrawn. An IV infusion of terlipressin 1 mg twice daily was given. After 3 days of discontinuation of sofosbuvir and daclatasvir, the edema of face was basically subsided, edema of lower extremities significantly subsided, serum creatinine decreased to 97 μmol/L, eGFR increased to 50 ml/(min·1.73 m2), and 24-hour urine protein was 0.398 g. After 8 weeks, the edema of lower extremities disappeared completely, serum creatinine was 64 μmol/L and eGFR was 85 ml/(min·1.73 m2) .
  • Wang Ranran, Gu Zhichun
    . 2016, 18(3): 222.
    A 25-year-old female patient with idiopathic pulmonary arterial hypertension received warfarin 1.25 mg/d for a long time. Her INR was controlled between 2.0-3.0. She received an IV infusion of levofloxacin 0.4 g once daily for urinary tract infection. Three days later, her INR increased from 2.7 to 3.3. Warfarin was withdrawn temporarily. Five days after warfarin withdrawal, her INR returned to 1.8. Levofloxacin was withdrawn when her urinary tract infection was improved. She received warfarin again and the dosage increased from 0.625 mg/d to 1.25 mg/d generally. On day 3 and 7 of recovery of warfarin′s primary dose, her INR returned to 2.3 and 2.5, respectively.
  • 安全信息
    . 2011, 13(3): 172-1.
  • 专家论坛
    . 2012, 14(1): 10-2.
  • 安全信息
    . 2007, 9(6): 448-448.
  • ADR咨询
    . 2003, 5(5): 355-355.
  • ADR咨询
    . 2004, 6(3): 205-205.
  • Wei Fenghua, Liang He
    . 2016, 18(3): 225.
    A 41-year-old female with repeated hematochezia for about 10 years prepared to have a colonoscopy in order to clarify a diagnosis. She took  sodium phosphate oral solution (45 ml dissolved in 750 heated water) orally for bowel preparation. Nine hours later she developed the symptoms of nausea, vomiting, dizziness, weakness, and apathy. The results of laboratory test showed K+ 3.0 mmol/L,Na+118 mmol/L,Cl- 92 mmol/L. She was diagnosed as hypotonic encephalopathy due to electrolyte disturbances which was induced by sodium phosphate. She received IV infusion of potassium chloride injection, potassium aspartate and magnesium aspartatse injection, 10% sodium chloride injection, and glycerol and fructose injection. Twenty-one hours later her apathy disappeared. The results of laboratory test showed K+ 4.35 mmol/L,Na+ 130 mmol/L,Cl- 109 mmol/L,Ca2+ 2.15 mmol/L about 27 hours later.
  • Lin Xiuli, Zeng Huiqing, Cai Xueying
    . 2016, 18(4): 300.
    A 68-year-old female patient received icotinib hydrochloride 0.125 mg thrice daily due to lung cancer with systemic multiple bone metastases. On the second day, the patient developed hematochezia with an amount of 20 ml blood in stool. Icotinib hydrochloride was stopped by herself. On the third day, hemafecia disappeared. On the fourth day, she restarted icotinib hydrochloride at the same dosage following the doctor′s advice. On the 5th day, hemafecia three times appeared, which was about 100-150 ml. Laboratory tests showed that platelet was 43×109/L (37×109/L before the drug administration) and hemoglobin was 119 g/L(132 g/L before the drug administration). Icotinib hydrochloride was withdrawn and the hemafecia did not recur for 4 days.
  • Lin Na, Lin Hong, Li Li
    . 2016, 18(2): 95.
    ObjectiveTo observe the influence of nasal administration of dexmedetomidine after induction of anesthesia on agitation of children in ophthalmologic surgery.MethodsThe study was designed as a randomized, double-blind and controlled trial. The children who underwent the ophthalmologic surgery in Department of Ophthalmology, Beijing Tongren Hospital from March  to October 2015 were divided into the dexmedetomidine group and the control group by a table of random number. After the induction of anesthesia, all the children  received the laryngeal mask (LMA) and the intranasal drugs were sprayed through the nasal mucosal drug delivery device (LMA MAD NasalTM). The dexmedetomidine group received hydrochloride dexmedetomidine injection (1 μg/kg) and the control group received 0.9% sodium chloride injection (0.01 ml/kg). The separation condition between the children and the parents in the 2 groups were judged by Ibrahim′s 4 comment method before operation. The children′s heart  rate, systolic blood pressure, respiratory frequency and pulse oxygen saturation (SpO2) were recorded at the different time points (before induction momentarily, 2 minutes after laryngeal mask insertion, 10 minutes after giving the intranasal drugs, 10 minutes after the starting of operation and the end of operation, respectively). The anesthesia time, operation time, staying time in post anesthesia care unit (PACU) and postoperative emergence agitation were also recorded. The children′waking condition in PACU were evaluated by Sundaram′s 4-point score after operation.ResultsA total of 97 children were enrolled in this study. The dexmedetomidine group comprised 47 cases and the control group 50 cases. The differences in age, sex and body weight between the 2 groups were not statistically significant (all P>0.05). The number of cases who had separation difficulty in the dexmedetomidine group and the control group were 26 (55.3%) and 18 (36.0%), respectively. The differences was not statistically significant. The differences in heart rate, systolic pressure; respiratory frequency, SpO2 and staying time in PACU between the children in the 2 groups at different time points during perioperative period were not statistically significant (all P>0.05). The incidence  of emergence agitation during recovery period in the dexmedetomidine group was lower than that in the control group[14.9%(7/47) vs 40.0%(20/50)], and the difference was statistically significant (P=0.007).ConclusionNasal administration of dexmedetomidine after induction of anesthesia (1 μg/kg) may decrease the incidence  of emergence agitation during  recovery period after general anesthesia and be propitious to children′postoperative recovery.
  • Xue Honglin, Wu Jingyu, Yang Lina, Fei Yan
    . 2017, 19(3): 224.
    A 45-year-old male patient received apatinib mesylate tablets 500 mg once daily for chemotherapy after the operation of colon cancer. On day 19 of treatment, the patient felt intermittent pain in hypogastrium, nausea, vomiting, anorexia, fatigue, mild palpitations and chest tightness. On day 33, he developed severe palpitation and chest tightness, wheezing and fever. On day 37, he developed the symptoms of absolutely irregular rhythm and heart sound intensity inequality. The results of laboratory test showed the following values: C-reactive protein 88 mg/L, serum calcium 1.98 mmol/L, serum potassium 3.3 mmol/L, creatine kinase 27.5 U/L, α-hydroxybutyric dehydrogenase 231 U/L, cardiac troponin I<0.02 μg/L, and B-type natriuretic peptide 56 ng/L. The patient was diagnosed as rapid atrial fibrillation which was related to apatinib mesylate tablets. Apatinib mesylate tablets was discontinued and the treatments of oxygen inhalation, relieving wheezing, diuresis, cardiac inotropic agents, and cardioversion were given. The patient received the sustained monitoring of cardioelectric and SpO2. On day 5 of drug withdrawal, the patient′s symptom of  chest pain was relieved, the symptoms of palpitations, chest tightness and shortness of breath were no longer appeared. His body temperature was 36.8 ℃. The results of cardioelectric monitoring showed sinus rhythm, normal heart rate (85-100 beats/min). On day 6 of drug withdrawal, the patient had not discomfort, the results of laboratory test showed the following values: serum potassium 3.8 mmol/L and serum calcium 2.11 mmol/L.
  • Liu Dawei, Liu Xing, Zhang Jiaorui, Guo Zhanwen, Xie Xiaodong, Li Jia, Ying Yuanyuan, Zheng Zhendong, Zhang Lihui, Ji Fahe
    . 2015, 17(6): 412-414.
    ObjectiveTo explore the effects of detecting of γ-glutamyltransferase (γ-GT) and leucine aminopeptidase (LAP) in urine on early diagnosis of kidney injury induced by zoledronic acid.MethodsThe patients with malignant tumor bone metastasis and received zoledronic acid from February 2012 to July 2014 in the General Hospital of Shenyang Military Command were enrolled into this study. The patient received IV infusion of zoledronic acid 4 mg, once for 25 to 35 days, finished within 30 minutes. The therapy was applied 3 times continuously. The patients′ urine and venous blood samples were taken before and after each medication′s morning. The levels of γ-GT, LAP in urine and serum creatinine were detected and compared.ResultsA total of 100 patients comprised 48 males and 52 females with a mean age of (60±11) years (25-82 years) were enrolled into the study. The levels of γ-GT, LAP in urine and serum creatinine before and after receiving zoledronic acid in the first time were (8±5), (7±5) U/L; (332±110), (375±113) nmol·s-1·L-1; (52±12), (54±12) μmol/L, respectively. The levels of γ-GT, LAP in urine and serum creatinine before and after receiving zoledronic acid the second time were (10±4),(12±5)U/L; (407±104),(377±126)nmol·s-1·L-1; (51±13),(53±13)μmol/L, respectively. The levels of γ-GT, LAP in urine and serum creatinine before and after receiving zoledronic acid the third time were (16±8),(19±9)U/L; (549±159),(662±199) nmol·s-1·L-1; (52±15),(53±14)μmol/L, respectively. The differences of levels of γ-GT, LAP in urine before and after 3 times of medication were statistically significant (all P<0.05). But the differences of levels of serum creatinine were not statistically significant (all P>0.05). The differences of levels of γ-GT, LAP in urine after 3 times of medication were statistically significant (all P<0.05). But the The differences of levels of serum creatinine were not statistically significant (all P>0.05).ConclusionsThe change in levels of γ-GT and LAP in urine was earlier than that of serum creatinine in patient with kidney injury induced by zoledronic acid. γ-GT and LAP in urine can be the early diagnostic marker of kidney injury induced by zoledronic acid.
  • 国外信息
    . 2005, 7(6): 468-469.
  • 病例报告
    Liu Haiyana;Luo Hongwenb;Wang Yafengc
    . 2008, 10(5): 0-0.

    A 58-year-old woman with upper respiratory infection started receiving an IV infusion of cefotaxime sodium 4.0 g dissolved in 250 ml of glucose 5% and sodium chloride 0.9%, followed by an IV infusion of asarone 8 mg in 250 ml of glucose 5%. No adverse reactions occurred during cefotaxime sodium infusion, but after receiving 20 ml of asarone infusion, the patient experienced dizziness, nausea, abdominal pain, vomiting, unconsciousness, and decreased blood pressure. Her BP was 85/42 mmHg, and her HR was 60 beats/min. The infusion was stopped immediately, and then oxygen, calcium gluconate, adrenalin, and promethazine were given. Five minutes later, her blood pressure normalized. The patient was treated with cefotaxime sodium several times before and no adverse reactions were found. Therefore, the anaphylactic shock was considered to be associated with asarone injection.
    KEY WORDSasarone; anaphylactic shock; adverse reaction

  • 不良事件
    . 2002, 4(5): 344-344.
  • Li Jinfeng, Hou Jia, Miao Xiaojin, Wang Quan, Li Fengjun, Zhang Yuan
    Adverse Drug Reactions Journal. 2022, 24(3): 166-168. https://doi.org/10.3760/cma.j.cn114015-20210906-00972
    A 59-year-old male patient received targeted drug recombinant human endostatin injection 15-mg intravenously once daily for 14 days for poorly differentiated adenocarcinoma of lung with brain metastasis. On the 17th day after drug withdrawal, erythema and pruritus appeared on the neck and chest, and then the erythema quickly spread to the whole body, with blisters and extensive epidermal exfoliation, accompanied by pruritus, pain, and mild fever. Toxic epidermal necrolysis caused by recombinant human endostatin was considered. High-dose of glucocorticoid and human immunoglobulin were given and 2 weeks later, the skin lesions healed basically.
  • Wang Shubo, Jiao Tingting, Dong Hongliang, Zhang Youcai, Wang Bailing
    Adverse Drug Reactions Journal. 2024, 26(3): 150-156. https://doi.org/10.3760/cma.j.cn114015-20230714-00521
    Objective To explore the risk factors of acute kidney injury (AKI) in patients with moderate and severe renal insufficiency after receiving voriconazole for injection and to establish a model for predicting the occurrence risk. Methods The study was designed as a retrospective study. The subjects were selected from patients with moderate to severe renal insufficiency who were hospitalized in Jiaozuo People′s Hospital of Henan Province from January 1, 2020 to December 31, 2022 and received treatment with voriconazole for injection. Through the hospital information system, clinical data of patients were collected, including basic information, clinical diagnosis, laboratory test indexes, comorbid diseases, and co-medication. Patients were divided into AKI and non-AKI groups according to whether voriconazole-related AKI occurred. AKI risk factors were analyzed using multiple logistic regression, and prediction models were established accordingly. Calibration curves were plotted using R4.2.3-software, and the model was internally validated using the k-fold cross-validation method. Results A total of 146 patients were enrolled in the study with an age of 72.4±13.8 years, including 84 males and 62 females; 61 patients (41.8%) of which developed voriconazole-related AKI. Compared with the non-AKI group, the white blood cell count, neutrophils percentage, proportion of patients with basic renal diseases, and proportion of patients with cardiovascular diseases were higher in the AKI group; the days of voriconazole injection treatment, proportion of patients with hematological diseases, and proportion of patients receiving glycopeptide drugs were lower in the AKI group. The results of multiple logistic regression showed that albumin [X1, odds ratio(OR)=0.946, 95% confidence interval(CI): 0.915-0.977, P=0.001], neutrophil percentage (X2, OR=1.013, 95%CI: 1.000- 1.026, P=0.001), and complicated with underlying renal diseases (X3, OR=2.230, 95%CI: 1.110-4.483, P=0.046) were independent influencing factors of AKI caused by voriconazole for injection in patients with moderate and severe renal insufficiency. The prediction model was established and the joint prediction factor Y=14.32X1+0.23X2-X3. When the maximum value of Youden index was 0.382, the best tangent point of receiver operating characteristic curve was -11.33. The internal cross-validation results showed that the accuracy of the model was 0.70 and the Kappa coefficient (consistency) was 0.37. Conclusions The incidence of AKI in patients with moderate and severe renal insufficiency after receiving voriconazole for injection was 41.8%. Albumin, neutrophil percentage and underlying renal diseases were the independent influencing factors. The calculation of joint predictors based on the above indicators was helpful to predict the risk of AKI and had a certain reference value for clinic.
  • He Yu′na, Wang Yini, Bai Hongmei, Yang Ziqi, Guo Jing, Yang Chun, Zhang Xue
    Adverse Drug Reactions Journal. 2023, 25(10): 601-606. https://doi.org/10.3760/cma.j.cn114015-20230227-20230123
    Objective To explore the occurrence and clinical characteristics of liver injury caused by immune checkpoint inhibitors (ICI) in cancer patients. Methods Medical records of cancer patients with normal liver function who used ICI during hospitalization in Beijing Friendship Hospital from January 2017 to December 2022 were collected, and those with liver injury related to ICI were screened out. The basic information of patients with ICI-related liver injury, treatment regime of ICI, concomitant medication, liver function before and after medication, intervention measures and outcomes were extracted, and the clinical characteristics of ICI-related liver injury were analyzed descriptively. Results A total of 155 patients with solid tumors were treated with ICI within the set time, of which 15 (9.7%) were diagnosed with ICI-related liver injury. Among the 15 patients, there were 6 males and 9 females, with a median age of 59 (41, 76) years. The suspected drug causing liver injury was camrelizumab in 5 patients, sugemalimab in 2 patients, serplulimab in 2 patients, toripalimab in 2 patients, sintilimab in 2 patients, penpulimab in 1 patient, and cadonilimab in 1 patient. All 15 patients received combined medication, such as traditional chemotherapy drugs, receptor tyrosine kinases inhibitors, and/or other ICIs. The median time from suspected ICI administration to liver injury in 15 patients was 22 (4-64) days, and the liver injury occurred after the first cycle of ICI treatment in 9 patients. The medians of peak value of alanine aminotransferase and aspartate aminotransferase were 157 (15-508) U/L and 131 (77-696) U/L, respectively; the total bilirubin was more than 2 times of the upper limit of normal in 3 patients. The liver injury was classified as hepatocellular type in 6 patients, cholestasis type in 5 patients, and mixed type in 3 patients; the type was unable to be determined due to lack of data in 1 patient. Among the 15 patients, 8 had liver injury of grade 2 and 7 had liver injury of grade 3; the suspected medication were discontinued after liver injury occurrence in 9 patients and did not discontinue in 6 patients. Seven and 5 patients recovered or basically had normal liver function after 1-4 months, respectively among those who stopped and did not stop ICI; the liver function did not return to normal in the other 3 patients at 2 to 9 months of follow-up. Conclusions ICI-related liver injury usually occurs after the first cycle of ICI treatment (within 1-2 months of medication), and the severity is mostly grade 2 or 3. The 3 clinical types of drug-induced liver injury (hepatocellular type, cholestatic type, and mixed type) are clinically visible. After the occurrence of liver injury, most patients have a good prognosis through timely discontinuation and/or treatments.
  • Chen Xueying, Yu Lingyan, Dai Haibin
    Adverse Drug Reactions Journal. 2025, 27(2): 122-125. https://doi.org/10.3760/cma.j.cn114015-20240219-00096
    A 58 year old female patient with anti synthetase syndrome received compound sulfa- methoxazole [containing trimethoprim (TMP) 80 mg and sulfamethoxazole (SMZ) 0.4 g, SMZ- TMP] 3 tablets thrice daily orally for the treatment of Pneumocystis jirovecii pneumonia. Before medication, the patient′s blood potassium was 3.3 mmol/L and blood chlorine was 116 mmol/L. Three days after SMZ-TMP treatment, the patient′s blood potassium was 5.7 mmol/L, blood chlorine was 114 mmol/L, blood pH was 7.3, urine pH was <5.5, blood chlorine was 114 mmol/L, and bicarbonate was 15 mmol/L. Hyperkalemia type renal tubular acidosis due to SMZ-TMP was considered. The dosage of SMZ-TMP was reduced to 2 tablets once daily orally. After 1 day of diuretic and potassium excretion treatments, the patient′s blood potassium levels returned to normal; after 2 days of the treatments, her blood chlorine was 109 mmol/L and bicarbonate was 17 mmol/L; after 3 days of the treatments, her chest CT showed emphysema in the neck and mediastinum. The dose of SMZ-TMP was changed to 3 tablets thrice daily orally, and at the same time intravenous infusion of ganciclovir 0.3 g twice daily was given. And again, her blood potassium increased and blood pH decreased. Sodium bicarbonate 1 g thrice daily orally was given to correct the acidosis. After adding SMZ-TMP for 2 days, SMZ-TMP dosage was reduced to 2 tablets once daily orally again. Seven days later, the patient′s vital signs were stable, her mediastinal emphysema was significantly improved, her blood potassium was 4.7 mmol/L, and blood pH was 7.4.
  • ADR咨询
    . 2005, 7(6): 470-470.
  • ADR咨询
    . 2001, 3(4): 278-278.
  • 海内外交流
    . 2014, 16(1): 60-1.
  • Song Rui, Chen Fengxin, Cai Haodong, Yan Jie
    . 2017, 19(6): 432.
    ObjectiveTo understand the clinical features and outcome of hepatitis B virus (HBV) reactivation after the direct-acting antiviral (DAA) treatment for hepatitis C virus (HCV) in HCV/HBV coinfection.MethodsStudies on HBV reactivation after DAA treatment for HCV in HCV/HBV coinfections which were reported in PubMed from Jan 1, 2011 to 31st Aug, 2017 were searched and retrieved. After document screening, data extraction and quality evaluation, the data of the cases with HBV reactivation after treatment with DAA drugs for the HCV/HBV coinfection were collected. A descriptive statistical analysis was performed.ResultsData of a total of 17 cases were collected, which were from 13 case-reports. There were 10 males and 7 females, the age ranged from 46 to 83 years with the mean of 62 years. There were 3 HBsAg-positive, 7 HBsAg-negative, and 7 HBsAg-unreported cases. Five of them had low level HBV DNA replication (230-2 300 IU/ml); in 11 cases HBV DNA was not detected and in 1 case it was not reported. Fourteen patients were planned to take DAA drugs for 12 weeks, 3 cases were 24 weeks. Reactivation of HBV occurred in 12 patients during the course of DAA treatment (4 to 21 weeks after starting), in 5 cases occurred 4 to 28 weeks after the end of treatment. Twelve of the 17 patients experienced severe reactivation of HBV and significant symptoms of exacerbation of liver disease. The levels of alanine aminotransferase, aspartate aminotransferase and HBV DNA were significantly higher than before, of which 4 of them developed liver failure. After HBV reactivation, 13 were treated with anti-HBV drugs, 11 of them improved, while 2 of them had liver failure and underwent liver transplantation. Four cases got spontaneous cure. Three of the 4 liver failure patients had cirrhosis before DAA treatment.ConclusionsDAA drugs may lead to HBV reactivation in HCV/HBV coinfected patients. HBV reactivation occurs not only in the course of drug treatment, but also in the months after the withdrawal of medication. Anti-HBV drugs in the reactivated cases generally got good prognosis. The presence of cirrhosis before DAA treatment is a risk factor for liver failure after HBV reactivation. The status of HBV infection should be assessed and HBV DNA levels and liver function should be monitored during the DAA drugs treatments.
  • Guo Ruituan, Zhang Gailian, Zhang Liyun, Gao Jinfang, Ma Dan
    . 2017, 19(2): 138-139.
    A 58-year-old female patient with systemic lupus erythematosus received an IV infusion of cyclophosphamide for four times (the therapeutic dose of 200, 400, 200, 400 mg, there were 8 days  apart between the first and the second medication, there were 12 days  apart between the second and the third medication, there were 29 days apart between the third and the fourth medication). There were no symptoms after first administration. On day 2 of the second administration, the patient showed limb shaking and sweating. The serum sodium decreased from 127 mmol/L before treatment to 107 mmol/L. Hyponatremia associated with cyclophosphamide was considered. Continuous intravenous pumping of concentrated sodium 2.3 g was given. Four days later, her serum sodium was 133 mmol/L, concentrated sodium was replaced by oral salt capsules one pill thrice daily. The level of serum sodium decreased slightly after the third and the fourth administrations then returned to normal levels after giving salt capsules.
  • Bai Fang, Tao Hai, Wang Peng
    . 2016, 18(3): 205.
    Drug-induced  dry eye disorders may cause potential damage to the ocular surface which can seriously decrease the quality of life of patients. The main clinical manifestations include eye dryness, burning-like feeling, foreign body sensation, itching, redness, photophobia, and blurred vision. The common drugs causing drug-induced dry eye disorders include systemic anticholinergic drugs such as psychotropic drugs, antihistamines and decongestant,  steroids, chemotherapeutic drugs, antiviral drug, anti-malarial, antirheumatic agents, chelating agent, and neurotoxin. The drug for local application around the eye include eye drops and botox with or without preservative. The main mechanisms of drug-induced  dry eye disorders may involve decrease of glandular secretion, affecting the aqueous layer and mucin layer; disturbing the stabilization of tear lipid layer and decreasing the lipid secretory volume; inducing the inflammatory reaction which damages the conjunctival goblet cells, eyelid glands, conjunctiva and cornea; reducing the degree of corneal sensation, the reduction of afferent nerve impulse, and tear production. Unnecessary drugs application in multiple systemic or topical use of drugs around the eye should be avoided. If the diagnosis of drug-induced dry eye was confirmed, the above-mentioned drugs should be withdrawn or replace the drugs which those having a low level of adverse drug reactions.
  • Gong Weina, Li Wei
    Adverse Drug Reactions Journal. 2020, 22(11): 658-659. https://doi.org/10.3760/cma.j.cn114015-20200429-00483
    Two patients (patient 1, a 77-year-old male; patient 2, a 27-year-old female) received intravenous injection of gadobenate dimeglumine before magnetic resonance imaging (MRI) on lumbar vertebra and midabdomen, respectively. One minute after the administration, the patients both developed severe anaphylaxis. Patient 1 manifested as numbness of lips, nausea, and chest tightness. After that, he developed swelling and cyanosis of lips, shortness of breath, inspiratory dyspnea, edema of uvula, and swelling of tongue. Patient 2 manifested as numbness of lips, irritating cough, and elevated blood pressure. After that, cyanosis of lips, salivation, shortness of breath, inspiratory dyspnea, scattered rashes all over the body, grade Ⅲ of tonsil enlargement, and edema of uvula successively appeared. They were diagnosed with severe anaphylaxis induced by gadobenate dimeglumine. Treatments such as high flow oxygen inhalation, intravenous injection of methylprednisolone, subcutaneous injection of adrenaline, intramuscular injection of promethazine, atomization inhalation of salbutamol and budesonide, and intravenous infusion of vitamin C and calcium gluconate were successively given. Symptoms in patient 1 were not improved and the cricothyroid membrane puncture and tracheotomy were performed immediately. Then his dyspnea was relieved and the swelling of tongue and uvula was gradually relieved. Dyspnea in patient 2 was relieved 1 hour after the anti-allergic treatments, one and a half hours later, her rash subsided and edema of tonsil and uvula were relieved.
  • 安全信息
    . 2007, 9(2): 151-151.
  • 安全信息
    . 2007, 9(5): 379-379.
  • ADR咨询
    . 1999, 1(2): 101-101.
  • Wei Anhua, Ding Yufeng, Peng Jinlan
    . 2018, 20(1): 30.
    ObjectiveTo systematically evaluate the risk of hypertension and serious hypertension due to vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) in patients with non-small cell lung cancer (NSCLC).MethodsThe related databases were searched for the randomized controlled trials (RCTs) on the hypertension induced by VEGFR-TKI before August 2017. The patients with NSCLC who were treated with VEGFR-TKIs were enrolled into the test group, the patients who received placebo and/or the patients in the test group who used the other drugs except VEGFR-TKI were enrolled into the control group. The outcomes of all RCTs were the incidence of hypertension and serious hypertension. The quality of the enrolled literature was evaluated by Jadad scoring system. The Meta-analysis was conducted by STATA 13.1 software. The results were expressed as relative risk (RR) and 95% confidence interval (CI).ResultsA total of 18 RCTs involving 10 020 patient were enrolled, including 5 274 in the test group and 4 746 in the control group. The result of literature′s quality evaluation showed 13 of high grade and 5 of low grade. The results of the Meta-analysis showed that the incidence of a hypertension and serious hypertension in test group were significantly higher than those in the control group, respectively [15.8% (834/5 274) vs. 3.8% (179/4 746), RR=4.11, 95%CI: 3.50-4.81, P<0.001; 3.49% (184/5 274) vs. 0.70% (33/4 746), RR=4.64, 95%CI: 3.22-6.68, P<0.001]. The results of the subgroup analysis showed that the incidences of hypertension and serious hypertension in the vandetanib group were significantly higher than those in the control group[15.1% (397/2 625) vs. 2.3% (49/2 136), RR=3.72, 95%CI: 2.80-4.95, P<0.001; 3.4% (90/2 625) vs. 0.6% (13/2 163), RR=5.99, 95%CI: 4.45-8.07,P<0.001]; the incidences of hypertension and serious hypertension in the sorafenib group were significantly higher than those in the control group[15.7% (201/1 278) vs. 5.4% (68/1 249), RR=2.90, 95%CI: 2.22-3.79, P<0.001; 4.0% (52/1 278) vs. 1.0% (12/1 249), RR=4.09, 95%CI: 2.21-7.55, P<0.001]; the incidences of hypertension and serious hypertension in the cediranib group were significantly higher than those in the control group [32.1% (89/277) vs. 8.7% (24/276), RR=3.70, 95%CI: 2.43-5.62, P<0.001; 12.2% (34/277) vs. 1.8% (5/276), RR=6.77, 95%CI: 2.68-17.08, P<0.001]; and the incidence of hypertension in the motesanib group was significantly higher than that in the control group [26.1% (139/533) vs. 6.5% (35/539), RR=4.02, 95%CI: 2.83-5.70, P<0.001].ConclusionThe risk of hypertension and serious hypertension may increase in the NSCLC patients who received VEGFR-TKIs.
  • Wang Xiaoyu, Jia Wangping, Guo Daihong, Kou Wei, Hu Pengzhou, Zhao Boyu, Pang Ning
    . 2017, 19(6): 414.
    ObjectiveTo evaluate the effects of  roxatidine acetate hydrochloride for injection (roxatidine) on liver and kidney function and analyze the related risk factors.MethodsThe electric medical records of the hospitalized patients who received roxatidine during January 1st, 2016 to December 31st, 2016 in Chinese PLA General Hospital were monitored by the autonomic monitoring system which was researched and developed by ourselves. The adverse drug reactions (ADR) were re-evaluated for the alarmed cases from the autonomic monitoring system by clinical pharmacists. The incidence rates of liver and kidney injury were calculated. The risk factors and the independent risk factors of liver and kidney injury due to roxatidine were confirmed by univariate and multivariate logistic regression analysis.ResultsData of a total of 9 284 patients who come from 34 clinical departments (Department of Urinary Surgery, Orthopedics, and Cardiac Surgery, etc.) were collected. Of the 9 284 patients, 5 308 (57.2%) were male, 3 976 (42.8%) were female. The dosage of roxatidine was 75 mg twice daily and the route of medication was intravenous infusion. The time of medication was 1-39 days and the median time was 3 (1, 5) days. Totally 8 268 patients were enrolled into the monitoring for roxatidine related liver injury. Eighty-six patients (1.0%) were judged to have liver injury, all the relevant evaluations were "possible", the degrees of liver injuries were mild. The 86 patients′ average age was (59±13) years, average body mass index (BMI) was (24.6±3.3) kg/m2, average time of medication was (8.1±4.1) days. Of 86 patients, 52 (60.5%) were combined with ceftriaxone sodium. The results of univariate logistic regression analysis showed that age, time of medication, and combination with ceftriaxone sodium were the risk factors of liver injury due to roxatidine. The results of multivariate logistic regression analysis showed that >65 years (OR=1.57, 95%CI: 0.99-2.43), >3 days of medication time (OR=14.14, 95%CI: 6.99-33.81), and combination use of ceftriaxone sodium (OR=2.31, 95%CI: 1.50-3.60) were the independent risk factors of liver injury due to roxatidine. Nine thousand two hundred and eighty-four patients enrolled into the monitoring of roxatidine related kidney injury. Twenty-six patients (0.3%) were judged as kidney injury, all the relevance evaluations were "possible", the degrees of kidney injuries were mild. The 26 patients′ average age was (59±15) years, average BMI was (22.0±6.2) kg/m2, average time of medication was (7.5±6.1) days. Of26 patients, 8 patients (30.8%) suffered from hepatobiliary diseases meanwhile. The results of univariate logistic regression analysis showed that the time of medication and suffering from hepatobiliary diseases were the risk factors of kidney injury due to roxatidine. The result of multivariate logistic regression analysis showed that >3 days of medication time (OR=3.57, 95%CI: 1.56-9.16) was the independent risk factor of kidney injury due to roxatidine. ConclusionsThe incidence rates of liver and kidney injuries due to roxatidine are lower. Roxatidine is safe in clinical medication. >65 years, >3 days of medication time, and combination use of ceftriaxone sodium are the independent risk factors of liver injury due to roxatidine. >3 days of medication time is the independent risk factor of kidney injury due to roxatidine.
  • ADR监测
    . 1999, 1(1): 47-48.
  • 个案分析
    . 2002, 4(5): 341-343.
  • 病例报告
    Hu Youhong
    . 2008, 10(1): 0-0.

    A 19yearold man with wound received IM tetanus antitoxin 1500 IU following a negative skin test. Half an hour later, he drank about 20 ml of spirit. He developed dizziness, generalized wheal, ear lobe and lip swelling, chest distress, palpitation, cold sweat, pallor, and dyspnoea immediately. Physical examination revealed a pulse rate of 108 beats/min, a respiratory rate of 28 breaths/min, and a BP of 60/30mmHg. After symptomatic treatment with oxygen, antianaphylaxis, and electrolyte supplements, the symptoms resolved gradually, and his vital signs returned to normal ranges.

  • 不良事件
    . 2004, 6(6): 419-419.
  • 消息·其他
    . 1999, 1(1): 65-67.
  • 不良事件
    . 2003, 5(4): 273-273.
  • Yang Xia, Yu Lei, Xie Yu, Xu Ting
    . 2017, 19(4): 310.
    A 64 year-old male patient with decompensated cirrhosis of liver after hepatitis B received intravenous injection of ademetionine 1,4-butanedisulfonate injection 1 000 mg and an IV infusion of magnesium isoglycyrrhizinate injection 200 mg once daily. His heart rate, respiration rate and blood pressure were 64 beats /min, 16 times/min and 100/65 mmHg, respectively. Five to six minutes after intravenous injection of ademetionine 1,4-butanedisulfonate for injection on the first day, the patient suddenly developed dyspnea, dysphoria, palpitation, lip cyanosis, wheezing, and moist rales in lungs. It was considered that the adverse reactions was induced by ademetionine 1,4-butanedisulfonate injection. The medication was withdrawn immediately. Bedside ECG monitoring showed that his heart rate, blood pressure and pulse oxygen saturation (SpO2) were 123 beats/min, 224/141 mmHg, and 0.8-0.9, respectively. The patient received mask oxygen inhalation, inhalation of bricalin and budesonide, intravenous injection of dexamethasone sodium phosphate injection 5 mg, an IV infusion of methylprednisolone 40 mg, and doxofylline and glucose for injection 300 mg. About 30 minutes later, the patient′s dyspnea was improved. His heart rate decreased to 76 beats/min, blood pressure  declined to 114/62 mmHg, and SpO2 returned to 0.99. The patient was ordered to be kept in bed and received nasal oxygen inhalation. The nasal oxygen was stopped on the third day and intravenous injection of magnesium isoglycyrrhizinate was given. The patient did not develop the symptoms mentioned above.
  • Liang Yao, Du Zhaoyang, Sun Lulu
    . 2016, 18(2): 145.
    A 35-year-old male patient received oral methylprednisolone 40 mg twice daily and mycophenolate mofelil 750 mg twice daily for hepatocirrhosis and portal hypertension induced by graft-versus-host disease. The heart rate was 76 times/min and electrocardiography was normal before medication use. On day 10, the symptom did not markedly improve, then an IV infusion of cyclosporine 1.25 mg/(kg·d) was added. About 30 minutes after the second infusion of cyclosporine, the patient developed chest distress and the electrocardiography showed bradycardia (heart rate was 46 beats/min). Cyclosporine was stopped. Methylprednisolone and mycophenolate mofelil were still used. Three days later, the heart rate was increased to 76 beats/min.
  • Wu Dongyuan, Liu Duo, Liu Shuang, Dong Mei
    . 2015, 17(2): 154-155.
    A 71-year-old male patient with gastric cancer received adjuvant chemotherapy with XELOX (intravenous infusion of oxaliplatin 200 mg on the first day and oral capecitabine 1 500 mg twice daily on day 2-15). During the first night after the capecitabine was taken, he developed dysuria. The major clinical manifestations were urination delaying, weak steam of urine, short distance of micturition and trickle micturition, and the symptoms exacerbated continuously. Physical examination findings were lower abdomen bulging, dullness to percussion, and there were no abnormality in the renal function. Tamsulosin hydrochloride 0.2 mg was given. The symptoms of dysuria relieved after 2 hours. The cumulative amount of urine was 600 ml by 6 ∶  00 am on the next day. Capecitabine was suspended. On the fourth day, the patient self-medicated with capecitabine 1 500 mg again due to his condition and the dysuria recurred after 5 hours. The symptom was relieved when tamsulosin hydrochloride 0.2 mg was given. So capecitabine was stopped and with the treatment with tamsulosin hydrochloride for 12 days, the dysuria didn′t recur.
  • Fang Zhenwei, Shi Jia, Shi Xiujin, Tang Huilin, Lin Yang
    ObjectiveTo evaluate the safety of dapagliflozin in Asian patients with type 2 diabetes mellitus (T2DM).MethodsRandomized controlled trials (RCTs) which evaluated the safety of dapagliflozin in Asian patients with T2DM from related databases and clinical trial registries from establishment to July 27, 2017 were searched. The patients who treated with dapagliflozin enrolled the dapagliflozin group. The patients who received placebo or other hypoglycemic agents enrolled the control group. The primary safety endpoints included cardiovascular safety, hypoglycemia, genital tract infection and urinary tract infection. The secondary safety endpoints included tumor, pyelonephritis, renal failure, fracture, amputation, etc. Meta-analysis was conducted using RevMan 5.3 and Stata 12.1 software. Risk ratio (RR) and 95% confidence intervals (CI) were calculated for dichotomous outcomes. Mean difference (MD) and 95%CI were calculated for continuous outcomes.ResultsA total of 9 RCTs involving 1 857 Asian T2DM patients enrolled the study. Of 1 857 patients, 1 180 patients were in the dapagliflozin group and 677 patients were in the control group [the placebo group: 619 patients; the dipeptidyl peptidase-4 (DPP4) inhibitor group: 58 patients]. The results of Meta-analysis showed that the differences of incidences of major adverse cardiovascular events (MACE), non-fatal myocardial infarction, non-fatal stroke, hypoglycemia, and urinary tract infection between the dapagliflozin group and the placebo group were all no statistical significance[0.58% (4/684) vs. 0.99% (4/406), RR=0.59, 95%CI: 0.17-2.02, P=0.40], [0.20% (1/510) vs. 0.63% (2/319), RR=0.43, 95%CI: 0.08-2.30, P=0.33], [0.52% (3/574) vs. 0.57% (2/352), RR=0.76, 95%CI: 0.18-3.24, P=0.71], [5.79% (65/1 122) vs. 8.08% (50/619), RR=0.92, 95%CI: 0.67-1.28, P=0.64], and [3.48% (39/1 122) vs. 3.39% (21/619), RR=1.03, 95%CI: 0.61-1.73, P=0.91], respectively. The incidence of genital tract infection in the dapagliflozin group was higher than that in the placebo group, but the difference was statistically significant [2.08% (23/1 105) vs. 0.33% (2/611), RR=3.42, 95%CI: 1.21-9.70, P=0.02]. The result of subgroup analysis showed that the incidence of genital tract infection in the dapagliflozin 10 mg group was higher than that in the placebo group, the difference was statistically significant [2.30% (13/564) vs. 0.36% (2/551), RR=4.56, 95CI: 1.32-15.78,P=0.02]. There were no significant correlations of other major endpoint events between the dapagliflozin groups in different dosage and the placebo group. The level of serum uric acid, compared with the baseline in the dapagliflozin group, decreased more than that in the placebo group, the difference was statistically significant (MD=-15.47 μmol/L, 95%CI: -30.35--0.60, P=0.04). There were no statistical significances of the incidences of tumor, renal adverse events, fracture, and amputation between the dapagliflozin group and the placebo group (all P>0.05). The level of estimated glomerular filtration rate, compared with the baseline in the dapagliflozin group, decreased similar to that in the DPP4 inhibitor group, the difference was not statistically significant [MD=1.70 ml/(min·1.73 m2), 95%CI:-7.79-11.19, P=0.73]. ConclusionsDapagliflozin is relatively safe in the treatment of Asian patients with type 2 diabetes. It should be vigilant for the probability of genital tract infection induced by dapagliflozin in the clinical practice.
  • Wang Chunhui, Xu Qing, Wu Wei, Li Xiaoyu, Lyu Qianzhou
    A 15-year-old boy with diffuse large B cell lymphoma received treatment with a R-CHOP chemotherapy regimen consisting of rituximab, cyclophosphamide, epirubicin, vincristine and prednisone. During the second cycle of chemotherapy, on day 24 after intravenous infusion of rituximab 600 mg, he developed cough and expectoration and his symptoms did not relieve after 2 weeks of treatment with ceftazidime. High resolution CT (HRCT) of the chest showed air bronchogram and mottling in his left upper lung and right lower lung, and inflammatory consolidation was considered. After receiving treatment with biapenem and azithromycin, his symptoms, inflammatory indices, and imaging findings did not significantly improve. According to the temporal correlation as well as pathological and etiological examination results, interstitial pneumonia and cancerous obstructive pneumonia associated with pulmonary infection or connective tissue disease were excluded, and organizing pneumonia induced by rituximab was considered. Rituximab was stopped and replaced by a CHOP chemotherapy regimen. In addition, antibacterial drugs were withdrawn and oral prednisolone 15 mg thrice daily was given. Thirty days later, the patient′s cough slightly relieved. However, when the dose of glucocorticoid was reduced to 15 mg/d, his cough and expectoration was slightly aggravated. Subsequently, the dose of prednisolone was increased to 40 mg/d, and 42 days later, was decreased to 20 mg/d. Eighty eight days later, the patient′s cough significantly  improved, HRCT of the chest revealed no abnormal findings in the left lung and no pleural effusion in the thoracic cavity, having mottling in the lower lobe of his right lung, and unobstructed bronchial.
  • Lin Juping, Ye Aiju
    Adverse Drug Reactions Journal. 2020, 22(11): 640-641. https://doi.org/10.3760/cma.j.cn114015-20200102-01110
    A 36-year-old female patient with ectopic pregnancy received conservative treatment with drugs. The doctor ordered oral mifepristone 100-mg once daily for 3 days and then a venous pumping of methotrexate (MTX) 80-mg dissolved in 0.9% sodium chloride injection 40-ml. On the 4th day, the nurse on duty did not strictly check the doctor′s orders. She mistakenly put a whole bottle of MTX (1-000-mg/bottle) into 0.9% sodium chloride injection 40-ml and pumped it intravenously within 30-minutes. Thirteen hours later, the patient developed nausea, vomiting, and abdominal pain. Two days later, the laboratory tests showed serum creatinine 325-μmol/L, urea nitrogen 8.6-mmol/L, and uric acid 501-μmol/L. Acute kidney failure was considered, which might be related to MTX. The patient was transferred to another hospital and got better after receiving hemodialysis and symptomatic treatments for 6 days. Twelve days later, the reexamina- tion results showed serum creatinine 73-μmol/L, urea nitrogen 4.1-mmol/L, and uric acid 363-μmol/L.
  • 消息·其他
    . 1999, 1(1): 67-67.
  • Wang Bin, Fu Jingjing, Fan Zhenping
    Adverse Drug Reactions Journal. 2024, 26(3): 184-185. https://doi.org/10.3760/cma.j.cn114015-20230926-00712
    A 37-year-old female patient with chronic hepatitis B was treated with levonorgestrel dispersible tablets (1.5-mg daily, 21 days of medication and 7 days off in a month) due to menstrual disorder. Three months later, the patient developed nausea, vomiting, poor appetite, and jaundice successively. Laboratory tests showed alanine aminotransferase 93-U/L, aspartate aminotransferase 68-U/L, γ-glutamyl- transferase 100-U/L, total bilirubin 206.1-μmol/L, and direct bilirubin 138.9-μmol/L. After excluding chronic hepatitis B reactivation and other hepatotropic virus infections by laboratory indicators, the liver injury was considered to be related to levonorgestrel. Levonorgestrel was stopped, liver protective and symptomatic treatments were given, the patient′s symptoms gradually disappeared, and liver function returned to normal after 2 months. The pathological examination result of liver puncture supported the diagnosis of chronic hepatitis B complicated with acute drug-induced liver injury.
  • 安全信息
    . 2011, 13(3): 141-1.
  • 安全信息
    . 2012, 14(6): 355-1.
  • Mo Yarui, Qian Yiyi
    Adverse Drug Reactions Journal. 2020, 22(2): 117-119. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.015
     A 74-year-old male patient underwent aortic valve replacement and coronary artery bypass grafting under general anesthesia and cardiopulmonary bypass for valvular heart disease. After cardiopulmonary bypass, protamine sulfate injection 50 mg (5 ml) was slowly intravenously injected to neutralize heparin sodium. At about 3 minutes of the injection (injection dose was about 15 mg), the patient suddenly developed decreased blood pressure, increased heart rate, and shortness of breath. Redness appeared on the skin around the injection site and there were light red rashes. In consideration of protamine allergy, the infusion was stopped immediately and anti-allergic drugs such as diphenhydramine, dexamethasone, and adrenaline were injected intravenously. After about 30 minutes, his blood pressure increased, heart rate decreased, and the rashes gradually subsided. Due to insufficient dose of protamine, the patient had more oozing and exudation in the thoracic cavity, resulting in a decrease in blood pressure and prolonged prothrombin time. Then protamine sulfate injection 50 mg(5 ml) diluted in 0.9% sodium chloride injection 100 ml was given by intravenous injection at a rate of 60 drops/min. The patient did not have any allergy again, the pleural drainage fluid was gradually reduced, and his blood pressure returned to normal.
  • Wang Shubo, Li Yong, Guo Zhilei
    A 56-year-old female patient was hospitalized because of suffering from chest discomfort for 2 days, and combined with hypertension and diabetes. She received oral valsartan capsules, metoprolol succinate sustained-release tablets, rosuvastatin calcium tablets, aspirin enteric-coated tablets, isosorbide dinitrate tablets, acarbose, and IV infusion of pantoprazole 80 mg+0.9% sodium chloride injection 100 ml and L-carnitine injection 4.0 g+0.9% sodium chloride injection 250 ml once daily. On the third day, about 2 hours after completion of pantoprazole and L-carnitine infusion, the patient presented with unresponsiveness to verbal stimuli, sudden loss of consciousness, limbs convulsion, eyes staring, trismus, and pink frothy sputum. Immediate ECG monitoring, open airway, sucking, oxygen therapy, intramuscular injection of 10 mg diazepam injection, rapid intravenous infusion of glycerol fructose sodium chloride injection 250 ml and 20% mannitol injection 125 ml were given. About 10 minutes later, the patient′s convulsion stopped but she still could not speak and she returned to normal the next day. Symptomatic epilepsy was considered. The probability of epilepsy induced by primary disease was excluded by brain CT and MRI functional imaging examinations and L-carnitine injection was suspected to be associated with the epilepsy. L-carnitine injection was discontinued and other drugs were continued and epilepsy did not recur.
  • . 2015, 17(5): 334.
    ObjectiveTo evaluate the risk of infection in monotherapy of tumor necrosis factor alpha (TNF-α) inhibitor.MethodsThe database of Pubed, Embase, Cochrane library, and Web with Science were searched from the inception to November, 2014. The literatures of randomized controlled trials in English which included reports that only used TNF-α inhibitor (the test group) and placebo or positive controlled drug (the control group)were selected. The methodological quality of the literatures which enrolled into the study were assessed by Jadad scale (inferior quality: <3 points, high quality: 3-5 points). The software RevMan 5.2 was used for Meta-analysis. The infection rate and the severe infection rate were expressed by relative risk (RR), Peto odds ratio (Peto OR)and 95% confidence interval (CI).ResultsA total of 33 trials presented by 32 reports, and 11 819 patients (7 408 cases in the test group using adalimumab or golimumab or infliximab or etanercept, respectively, and 4 411 cases in the control group using placebo, positive control drug such as methotrexate or salazosulfapyridine, respectively )were enrolled into the Meta-analysis. The Jadad scores of the 33 trials were all≥3 points. The results of the Meta-analysis showed that the overall total incidence of infection in patients who used TNF-α inhibitors only was higher than that in the patients who used placebo [33.03% (1 702/5 153) vs.29.53%(873/2 956), RR=1.17, 95%CI: 1.09-1.25, P<0.000 01]. There was no significant difference in the overall incidence of infection between the test group and the positive controlled drug group [50.1% (362/723)vs.48.3%(320/662), RR=1.10, 95%CI: 0.90-1.34, P=0.36]. There were no significant differences in the incidence of severe infection between the test group and the placebo control group, the positive controlled drug group [1.4% (73/5 067)vs.1.7% (48/2 902), Peto OR=0.90, 95%CI: 0.61-1.32, P=0.46; 2.4% (34/1 410) vs.2.8% (28/976), RR=1.10, 95%CI: 0.90-1.34, P=0.36]. The results of subgroup analysis showed that the incidence of infection in patients who used adalimumab, or golimumab or infliximab only were significantly higher than that in the patient who used placebo [41.4% (568/1 373) vs.39.1% (361/923), RR =1.11, 95% CI: 1.01-1.23, P=0.04; 25.5% (397/1 558) vs.19.2% (120/625), RR: 1.22, 95%CI: 1.02-1.45, P=0.03; 38.2% (297/777) vs.27.7% (114/411), RR=1.35, 95%CI: 1.13-1.61, P=0.001]. There was no significant difference in the incidence of infection between the patients who used etanercept and the patients who used placebo [30.4% (440/1 445) vs.27.9% (278/997), RR=1.13, 95%CI: 0.99-1.28, P=0.06]. The incidence of severe infection in patients who used golimumab was significantly lower than that in the patient who used placebo [0.59% (8/1 355) vs.2.12% (11/520), Peto OR=0.21, 95%CI: 0.08-0.59, P=0.003]. There were no significant differences in the incidence of severe infection between the patients who used the other 3 kinds of drugs and the patients who used  placebo (all P>0.05).ConclusionsThe monotherapy with TNF-α inhibitor may increase the overall incidence of infection, but will not increase the incidence of severe infection. The monotherapy with TNF-α inhibitor is relatively safety in clinical practice.
  • 安全信息
    . 2006, 8(4): 309-309.
  • 会议纪要
    . 2014, 16(6): 382-1.
  • 病例报告
    ZHANG Cheng-pu;TAO Hai;ZHANG Jian;ZHAO Jian-sheng
    . 2012, 14(4): 266-2.
    An 8-year-old boy was given an intravenous infusion of Qingkailing injection for upper respiratory infections ( dose not stated ). About one hour after infusion, he developed flushed face, redness and swelling of bilateral eyelids, ophthalmalgia, lacrimation, photophobia, and difficulty keeping eye open, followed by a generalised, pruritic, erythematous maculopapular eruption. However, his symptoms did not attract attention and the infusion was not stopped. Two hours later, the infusion was finished and his symptoms aggravated and the patient presented with herpes on his lips which gradually progressed to ulceration. After a 12-day anti-allergic therapy, the symptoms including redness and swelling of eyelids, difficulty keeping eye open, and generalised skin manifestations gradually improved, while his ophthalmalgia, lacrimation, and photophobia remained unchanged. About 1.5 year later, entropion of both eyes and lacrimal duct obstruction occurred. His symptoms markedly improved after undergoing surgical correction of entropion at the age of 11 years.
  • 病例报告
    GU Sheng-wang;JIANG Zhao-rong
    . 2012, 14(3): 177-2.

    A 55-year-old female received an IV infusion of matrine and glucose injection 250 ml once daily for liver cancer and cirrhosis. The next day, she developed watery diarrhea, and matrine and glucose injection was stopped immediately. On day 3, diarrhea disappeared. Two days later, the patient was readministered an IV infusion of matrine and glucose injection 250 ml once daily. On day 3, she presented with severe painless watery diarrhea. Despite receiving garlicin, norfloxacin, compound diphenoxylate, and cefoxitin, her diarrhea did not improve. On day 4, matrine and glucose injection was discontinued. The following day, the patient’s diarrhea resolved.

  • ADR系列问答
    . 2007, 9(4): 304-304.
  • Niu Ziran, Wang Zixi, Zhang Bo
    Adverse Drug Reactions Journal. 2023, 25(9): 517-520. https://doi.org/10.3760/cma.j.cn114015-20230828-00640
    Anaphylaxis is a severe, life-threatening, immediate, and systemic allergic reaction, and may lead to serious consequences due to delayed diagnose or improper treatment. Guidelines at home and abroad recommend epinephrine as a first-line treatment for anaphylaxis. But there are still some problems such as insufficient use, inappropriate administration route or dosage of epinephrine in the treatment of anaphylaxis in China. The timing (as early as possible), route (intramuscular injection is preferred), and dosage of epindphrine should strictly follow the recommendations of relevant guidlines. Epinephrine autoinjectors can win more rescue time for patients with anaphylaxis, and can be equipped and used after training by clinicians.
  • Song Jianbo, Zhao Liqin, Zhou Min, Wang Guangying, Li Yuanping, Wen Hongping
    Adverse Drug Reactions Journal. 2023, 25(8): 482-490. https://doi.org/10.3760/cma.j.cn114015-20230202-00047
    Objective To explore the clinical characteristics of tumor necrosis factor-α (TNF-α) inhibitors-related optic neuritis. Methods The database at home and abroad (as of November 2022) were searched and the case reports on optic neuritis induced by TNF-α inhibitors were collected. Clinical data including gender, age, use of TNF-α inhibitors, combination drugs, time to onset of optic neuritis, clinical manifestations, results of ancillary examinations, treatment and outcome were extracted and analyzed descri- ptively. Results A total of 37 patients were enrolled in the study, including 16 males and 21 females, with an average age of 44 years; 11 patients were treated with adalimumab, 16 with infliximab, 8 with etanercept, 1 with golimumab, and 1 with peselizumab. Among them, 5 patients had previously been treated with other TNF-α inhibitors. The primary disease was rheumatoid arthritis in 15 patients, Crohn′s disease and ulcerative colitis disease in 8 patients, psoriatic arthritis in 3 patients, anterior uveitis in 2 aptients, and other rheumatic and inflammatory diseases in 9 patients. Of them, 4 patients were complicated with other diseases. The median time from TNF-α inhibitors use to optic neuritis occurrence was 4.5 months (3 days to 2 years). The most common clinical manifestations were decreased vision and ocular movement pain. Of the 37 patients, cerebrospinal fluid (CSF) analysis was performed in 8 patients, and 6 were abnormal. CSF oligoclonal bands were detected in 7 patients, and 4 were positive. Magnetic resonance imaging of the brain or orbit was performed in 32 patients, 11 patients showed optic nerve enhancement, 14 patients had brain lesions, and 5 patients had cervical or spinal cord lesions. Visual acuity was examined in 30 patients, 29 of which showed decreased vision. Of the 37 patients, 24 patients stopped the suspected drugs and were treated with glucocorticoid (GC), 6 patients only stopped medication but not treated with GC, and it was not described in 7 patients, 5 of whom were treated with GC. Of the 37 patients, 30 patients recovered partially or completely after discontinuation of the drugs and/or treated with GC, 6 patients were not improved and 1 patient was deteriorated. Conclusions TNF-α inhibitors-related optic neuritis mostly occurs within the first 6 months of treatment, and more common clinical manifestation is visual acuity loss, with or without brain MRI lesions. Early detection and intervention usually lead to a better prognosis.
  • Fan Caixia, Xu Kun, Li Hongyan, Liu Wenqi, Zhu Zongfa, Li Zhengrong, Bi Yunyan, Zhang Shilin, Zhu Xiaosong, Wang Shiming
    Adverse Drug Reactions Journal. 2024, 26(4): 198-203. https://doi.org/10.3760/cma.j.cn114015-20231109-00789
    Objective To investigate the effect of intravenous application of furosemide on occurrence of cardiac surgery-associated acute kidney injury (CSA-AKI) in patients after cardiac surgery. Methods The electronic medical records of patients undergoing cardiac surgery in Linyi People′s Hospital from January 2014 to December 2022 were collected and retrospectively analyzed. According to whether CSA-AKI occurred after surgery, the patients were divided into AKI group and non-AKI group and the clinical characteristics between the 2 groups were compared. Multivariate logistic regression was used to analyze the influencing factors of CSA-AKI, and the odds ratio (OR) and its 95% confidence interval (CI) were calculated. Results A total of 2-633 patients were enrolled in the analysis, including 1-601 males (60.8%) and 1-032 females (39.2%). The age was (62.8±8.9) years, ranging from 18 to 85 years. Among the 2-633 patients, 491 (18.6%) developed CSA-AKI. Multivariate logistic regression analysis showed that after adjusting for factors such as the type of operation, intraoperative cardiopulmonary bypass, hypertension, diabetes mellitus, hypoalbuminemia, NYHA cardiac function class Ⅲ/Ⅳ, intraoperative/postoperative aortic balloon counterpulsation, preoperative serum creatinine level, operation duration, and the number of vasoactive drugs used after the operation, postoperative intravenous application of furosemide was still independently associated with the occurrence of CSA-AKI (OR=2.161, 95%CI: 1.720-2.715, P<0.001). Conclusions The incidence of CSA-AKI in patients enrolled in this study was 18.6%. Intravenous use of furosemide after cardiac surgery can increase the risk of CSA-AKI.
  • Fan Ke, Dong Bin
    Adverse Drug Reactions Journal. 2024, 26(8): 509-512. https://doi.org/10.3760/cma.j.cn114015-20231218-00909
    A 35‑year‑old young male was treated with carbamazepine, oxcarbazepine, levetiracetam, valproate and other antiepileptic drugs for a long time due to secondary epilepsy after viral encephalitis. The epilepsy seizures had not been fully controlled. After about 2 years of treatments, the medication was switched to oral phenobarbital tablets 30 mg thrice daily due to the recurrence of epilepsy. And phenobarbital was discontinued the next year due to well controlled seizures. Four years after drug withdrawal, the patient suffered from coronavirus disease 2019 and the recurrence of epilepsy, and took the original dose of phenobarbital orally again by himself. Three months after medication, the patient had a sudden spontaneous multisegmental thoracic vertebral compression fracture. Vertebral calcium phosphate cement augmentation was performed and phenobarbital was continued. About 2 years after medication, the patient suffered from spontaneous thoracic 12 vertebral compression fracture, with serum 25-hydroxy vitamin D 13.5 μg/L and osteocalcin 8.57 μg/L. Osteoporotic fractures caused by phenobarbital were considered, and the drug was replaced by oral perampanel tablets 2 mg once daily, and vitamin D and calcium were supplemented. At a follow‑up of 9 months, the patient′s epilepsy was well controlled, no new fracture events
    occurred, serum 25-hydroxy vitamin D was 21.6 μg/L, and osteocalcin levels was 10.36 μg/L.

  • 安全信息
    . 2007, 9(1): 68-68.
  • 安全信息
    . 2007, 9(1): 68-73.
  • ADR咨询
    . 2005, 7(1): 74-74.
  • 论著
    Fu Shihui;Zhu Bing;Wang Hao;Wang Liang;Liu Yuan;Ye Ping;Luo Leiming
    . 2011, 13(1): 7-6.
    Objective: To explore the efficacy and safety of recombinant human brain natriuretic peptide (rhBNP) in patients with advanced age and acute decompensated heart failure. Methods: A randomized controlled trials was performed. From January 2008 to December 2010, 80 hospitalized patients with advanced age and acute decompensated heart failure in Chinese PLA General Hospital were enrolled in this study. They were randomly divided into the conventional treatment group (conventional group) and the conventional treatment plus rhBNP group (rhBNP group) by using ballot method. There were 40 patients in each group. The patients in the conventional group received the conventional treatment for acute decompensated heart failure, and patients in the rhBNP group received the conventional treatment plus a continuous IV infusion of rhBNP 0.5-1.0 mg in 50 ml of normal saline via a pump at a rate of 0.007 5-0.015 0 μg·kg-1·min-1 for 10-15 hours once daily. The course of treatment was 13 days. The scores of dyspnea and edema, net water loss volume, heart rate, blood pressure, and serum creatinine level in the two groups before and after treatment (on days 4, 8, and 14) were compared. Results: The conventional group comprised 37 males and 3 females with mean age of (88±4)years; The rhBNP group comprised 38 males and 2 females with mean age of (86±5) years. There was no statistically significant differences in the baseline clinical characteristics and the drugs used for the treatment of heart failure between the two groups before treatment. On day 4, there was no statistically significant difference in the scores of dyspnea between the two groups (P>0.05). On days 4 and 8, the scores of dyspnea in the rhBNP group were significantly lower than those in the conventional group (all P<0.05). On days 4, 8 and 14, the scores of edema in the rhBNP group were significantly lower than those in the conventional group (all P<0.05). On days 4, 8 and 14, the net water lose volume in the rhBNP group was significantly greater than those in the conventional group [263.5 (-793, 2184)ml vs -129.0(-1249, 3636) ml,239.5 (-754,1370)ml vs -29.5 (-1364, 2242) ml, and 386.5 (-564,1490)ml vs 71.0 (-2274,1660) ml, respectively; all P<0.05]. On days 4, 8 and 14, there were no statistically significant differences in blood pressure and serum creatinine level between the two groups(all P>0.05). On days 4 and 8, the heart rates in the rhBNP group were significantly lower than those in the conventional group [(73±13)beats/min vs (81±17)beats/min and (70±10)beats/min vs (79±16)beats/min, respectively; all P<0.05]. Conclusion: The conventional treatment plus rhBNP has better efficacy and safety in treating patients with advanced age and acute decompensated heart failure.
  • 安全信息
    . 2014, 16(1): 61-1.
  • Yang Qiuya, Dong Yafen, Hu Bin
    . 2015, 17(5): 393.
    A 51-year-old male patient with hyperlipidemia, uremia, uremic cardiomyopathy, hypertension, osteoporosis and type 2 diabetes received atorvastatin calcium 20 mg/d, olmesartan 20 mg/d, nifedipine 30 mg/d, isosorbide 5-mononitrate 40 mg/d, calcitriol 0.5 μg/d, calcium acetate 0.6 g/d. In addition, the patient received hypodermic injection of insulin according to blood sugar level, and maintained peritoneal dialysis. The patient stopped using atorvastatin and switched to bezafibrate dispersible tablets 0.2 g three time daily because of his high levels of total cholesterol (7.0 mmol/L) and triacylglycerol (9.9 mmol/L) . On day 4 of changing the prescription, the patient complained of whole body pain. On day 6 of changing the prescription, the patient became anxious, irritable, and had darkened peritoneal dialysis fluid. Laboratory test showed the following values: white blood cell count (WBC) 33.0×109/L, neutrophil 0.95, creatine kinase (CK) >10 000 U/L, myoglobin 2 876 μg/L, alanine aminotransferase (ALT) 460 U/L, urea 20.9 mmol/L, and creatinine (Cr) 1 294 μmol/L on day 7 of changing medical prescription. The patient was diagnosed as rhabdomyolysis due to bezafibrate. Bezafibrate was withdrawn on the same day. He received the symptomatic treatments including liver and kidney protection, nourishing myocardium, and vein-vein hemodialysis besides continuing to take the other drugs mentioned above. On day 7 of stopping bezafibrate the patient′s mental symptoms improved. Laboratory test showed the following values: WBC 16.0×109/L, neutrophil 0.81, CK 154 U/L, myoglobin 288 μg/L, ALT 21 U/L, urea 12.0 mmol/L, and Cr 564 μmol/L on day 16 of stopping bezafibrate.The patient did not complain of pain, the symptoms of anxiety and irritability did not appear until the day 60 of drug withdrawal.
  • Wang Tailiang, Qin Zhiyi
    . 2015, 17(2): 159-160.
    A 36-year-old male underwent local resection of hemangioma of liver under general anesthesia. Physical examination showed the following results: body temperature was 36.0 ℃, heart rate 71 beats/min, breathing rate 14 breathes/min, blood pressure 120/82 mmHg. The patient received induced anesthesia with 1.5% halothane. And then received intravenous administration of midazolam, esmolol, propofol, remifentanil, suxamethonium chloride, and vecuronium bromide, successively. The patient′s hepatic hemangioma was  resected smoothly. He developed high fever (40℃), his heart rate was 140 beats/min, blood pressure 96/52 mmHg 90 minutes later. The anaesthetist considered as malignant hyperthermia due to halothane combined succinylcholine chloride. Halothane was withdrawn immediately. He underwent comprehensive treatments immediately, including physical cooling; correcting acidosis, hyperkalemia, and arrhythmia; elevating blood pressure; diuresis, protection of renal function, and synchronous direct current cardioversion. The patient developed ventricular tachycardia, arrhythmia, cardiac arrest, and high temperature (>42 ℃), successively during the treatment. Finally, the patient died despite resuscitation attempts about 3 hours after malignant hyperthermia occurred.
  • Ma Lin;Fu Xiaoxiu;Hu Aijun
    . 2015, 17(1): 76-2.
    A 2 and a half years old boy was considered to have pneumonedema due to his pulse oxygen saturation of 0.78 and exudative lesion in bilateral lungs and received auxiliary treatment of tracheal intubation. During the treatment of tracheal intubation, to ensure the boy calm, he was given a continuous intravenous pumping of dexmedetomidine 200 μg at the rate of 10 μg per hour. Seven hours later, his heart rate deceased to 63 beats/min. Dexmedetomidine was withdrawn immediately. One hour later, the boy′s heart rate increased to 130-140 beats/min.
  • Shen Jie, Ren Hongying, Qi Hong, Tan Fengping
    . 2018, 20(3): 230-232.
    A 29-year-old female patient received cervical injection of oxytocin injection 10 U twice daily because of postpartum subinvolution of uterus. On the 4th day of treatment, the patient received a transrectal administration of carboprost methylate suppositories 0.5 mg due to poor efficacy of oxytocin injection. About 20 minutes after rectal medication, the patient developed diarrhea with watery stools 4 times within 70 minutes. About 2 hours after rectal medication, the patient developed persistent abdominal colic and gradually aggravated. Intramuscular injections of metoclopramide 10 mg and pethidine 100 mg were given. However, her abdominal pain did not improve obviously and abdominal ultrasound examination showed no abnormality. Her diarrhea and abdominal pain were considered to be related to carboprost methylate. Symptomatic supportive treatments with spasmolysis, antidiarrheal, potassium supplementation, fluid replacement were given continuously. Five days later, diarrhea and abdominal pain disappeared.
  • Wu Dengke, Gao Jie
    ObjectiveTo explore the clinical characteristics of hepatic sinusoidal obstruction syndrome (HSOS) related to Tusanqi (senecio chrysanthemoides) and fully recognize the severity of the disease.MethodsMedical record data of patients who were diagnosed as having Tusanqi-related HSOS in the First Affiliated Hospital of Soochow University from January 2011 to May 2018 were collected and analyzed retrospectively.ResultsA total of 19 patients entered the study, including 12 males (63.2%), 7 females (36.8%), and the median age was 65(44-82) years. All the patients mistook Tusanqi for Sanqi (Panax notoginseng), and they themselves took Tusanqi steeping in water(13 cases), decocting in water (4 cases) or soaking in wine(2 cases). The reasons for taking Tusanqi were trauma(11 cases), hypertension (4 cases of), lumbar intervertebral disc herniation(2 cases), lumbar fracture(1 cases), and prostatitis hemorrhage(1 cases). The median time of Tusanqi use was 23(5-212) days. The median time from Tusanqi initiation to onset of HSOS was 20 (5-212) days. The RUCAM score were 4 for 1 case, 5 for 7 cases, 6 for 5 cases, 7 for 4 cases, 8 for 2 cases. The patients′ Child-Pugh was classified as follows: A (2 cases), B (8 cases) and C (9 cases). The types of liver injury were cholestasis in 5 cases, hepatocyte injury in 6 cases, and mixed type in 8 cases. The severity of HSOS was classified as super severe in 5 cases, severe in 4 cases, moderate in 7 cases, and mild in 3 cases. The clinical manifestations included abdominal distension, poor appetite, jaundice, hepatomegaly, ascites, and edema of both lower limbs. Laboratory abnormalities included elevated ALT, AST, TBil, and INR levels, prolonged prothrombin time, and decreased PLT and serum albumin levels. The imaging findings were mainly ascites, hepatomegaly, decreased density of liver parenchyma, uneven liver enhancemen, and unclear hepatic vein. The treatment measures included hepatoprotection, diuresis, anticoagulation, hormone therapy, improvement of microcirculation and plasmapheresis. The outcomes of the patients showed that 15 patients improved, and 4 died; and the mortality was 21.1%.ConclusionsTusanqi-related HSOS was a serious adverse reaction with decompensated liver disease as the main manifestation, poor prognosis and high mortality. Therefore, public education of safe drug use should be strengthen to avoid the misuse of Tusanqi.
  • Wang Ping, Zhang Wen, Zhao Yong, Zeng Yan
    A 79-year-old female patient with a secondary pulmonary hypertension received an oral bosentan 62.5 mg twice daily. Her liver function was normal before medication. On the   day 57 after begining of the medication, laboratory tests showed aspartate aminotransferase(AST) 44 U/L, alanine aminotransferase (ALT) 43 U/L, gamma glutamyl transferase (γ-GT) 166 U/L, alkaline phosphatase (ALP) 249 U/L, glutamate dehydrogenase(GDH)30.8 U/L, albumin 31.7 g/L, total bilirubin(TBil) 50.0 μmol/L, direct bilirubin(DBil) 23.8 μmol/L , and indirect bilirubin(IBil) 26.2 μmol/L. On the   day 62, the patient developed yellowish discoloration of skin and sclera, fatigue and loss of appetite. Laboratory tests showed the following levels: AST 39 U/L, ALT 32 U/L, GGT 276 U/L, ALP 417 U/L, GDH 14.5 U/L, albumin 33.6 g/L, TBil 120.8 μmol/L, DBil 65.3 μmol/L, IBil 55.4 μmol/L. Drug-induced liver injury was diagnosed. Bosentan was withdrawn and hepatoprotective agents were given. Five days after the drug withdrawal, her jaundice disappeared. Thirty-three days after the drug withdrawal, laboratory tests showed AST 25 U/L, ALT 13 U/L, GGT 43 U/L, ALP 125 U/L, GDH 1.8 U/L, albumin 37 g/L, TBil 24.0 μmol/L, DBil 9.2 μmol/L, and IBil 14.8 μmol/L.
  • Qiu Yanlong, Ma Ling, Zhu Xiaolin, Li Zhengrong
    Adverse Drug Reactions Journal. 2019, 21(3): 231-232. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.016
    A 58-year-old female patient took orlistat 0.12 g orally once daily by herself due to obesity. After 13 months, she developed fatigue and anorexia. Laboratory tests showed alanine aminotransferase(ALT) 1 603 U/L, aspartate aminotransferase(AST) 1 265 U/L, alkaline phosphatase(ALP) 310 U/L, direct bilirubin(DBil) 8.4 μmol/L, and indirect bilirubin(IBil) 13.4 μmol/L. She was diagnosed with liver injury. Orlistat was discontinued, considering its relationship with the liver injury. And an IV infusion of diammonium glycyrrhizinate 150 mg (added to 250 ml of glucose injection) once daily was given. Two days later, the diammonium glycyrrhizinate was replaced by IV infusion of magnesium isoglycyrrhizinate 100 mg (added to 100 ml of 0.9% sodium chloride injection) once daily because that the symptoms did not relieve. After 6 days of treatment with magnesium isoglycyrrhizinate, the patient′s symptoms relieved and she had ALT 124 U/L, AST 73 U/L, ALP 73 U/L, DBil 3.1 μmol/L, and IBil 7.3 μmol/L. After 1 month, liver function tests showed ALT 30 U/L, AST 57 U/L, ALP 93 U/L, DBil 3.0 μmol/L, and IBil 11.8 μmol/L.
  • Fang Zhenwei, Shi Jia, Shi Xiujin, Zhang Lin, Zhang Yi, Lin Yang
    Adverse Drug Reactions Journal. 2019, 21(3): 190-197. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.006
    ObjectiveTo evaluate the risk of acute kidney injury (AKI) induced by sodium glucose co-transporter 2 (SGLT2) inhibitors (canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin).MethodsReports of AKI events induced by SGLT2 inhibitors and non-SGLT2 inhibitors received from January 1, 2013 to September 30, 2018 in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database were collected. The relationship between the drugs mentioned above and the AKI events in all patients and especially in patients with diabetes mellitus, respectively, were analyzed by the method of reporting odds ratio (ROR).ResultsA total of 2 949 reports of SGLT2 inhibitors-induced AKI (2.50% of 117 843 AKI event reports in the database during the study period), and 114 894 reports of non-SGLT2 inhibitors-induced AKI were retrieved from the database. The ROR values of AKI events induced by overall SGLT2 inhibitors, canagliflozin, dapagliflozin, and empagliflozin in all patients were 4.14 (95%CI: 3.98-4.30), 5.58 (95%CI: 5.35-5.83), 2.62 (95%CI: 2.35-2.92), and 1.96 (95%CI: 1.76-2.19), respectively, and in patients with diabetes mellitus were 2.84 (95%CI: 2.71-2.98), 3.90 (95%CI: 3.69-4.12), 1.70 (95%CI: 1.48-1.94), and 1.30 (95%CI: 1.15-1.48), respectively. Due to the short time to market, less than 3 reports of AKI events induced by ertugliflozin were reported, thus ROR analysis was not conducted for ertugliflozin. The analyses of combined medication showed that in all patients, the ROR value of AKI events induced by SGLT2 inhibitors was 8.05 (95%CI: 7.10-9.13) when SGLT2 inhibitors were combined with diuretics, which increased by 80.90% compared with that when SGLT2 inhibitors were given alone and in patients with diabetes mellitus, it was 6.07 (95%CI: 5.27-7.00), which increased by 92.09%; in all patients, the ROR value of AKI events induced by SGLT2 inhibitors was 5.87 (95%CI: 4.89-7.04) when SGLT2 inhibitors were combined with non-steroidal anti-inflammatory drugs (NSAID), which increased by 39.43% compared with that when SGLT2 inhibitors were given alone and in patients with diabetes mellitus, it was 4.66 (95%CI: 3.79-5.74), which increased by 61.25%; in all patients, the ROR value of AKI events induced by SGLT2 inhibitors was 5.60 (95%CI: 5.12-6.14) when SGLT2 inhibitors were combined with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, which increased by 25.56% compared with that when SGLT2 inhibitors were given alone and in patients with diabetes mellitus, it was 4.05 (95%CI: 3.66-4.48), which increased by 27.36%.ConclusionsSGLT2 inhibitors might increase the risk of AKI and this risk was mainly from canagliflozin, suggesting that dapagliflozin and empagliflozin were relatively safe to patients. The risk of AKI might increase when SGLT2 inhibitors were combined with diuretics or NSAID.
  • Zeng Dayong, Dong Jiashan, Huang Pinfang, Wang Changlian, Lin Rongfang
    Adverse Drug Reactions Journal. 2020, 22(1): 48-49. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.01.012
    A 65-year-old male patient was treated with pyridostigmine bromide tablets (30-mg thrice daily), azathioprine tablets (75-mg twice daily), and prednisone acetate tablets (15-mg once daily) for myasthenia gravis. Two months later, the patient developed abdominal pain, nausea, and vomiting. The laboratory tests showed the blood lipase (LPS) 909-U/L and the urine amylase (AMS) 3-838-U/L. The results of abdominal ultrasonography and imaging examination were consistent with the manifestations of pancreatitis. Above-mentioned drugs were not stopped and the patient was treated according to the conventional treatment regimen of acute pancreatitis. However, the symptoms did not improved significantly. On the 11th day after the onset of the disease, he received subcutaneous infusion of octreotide injection,intravenous infusion of pantoprazole sodium for injection, oral metronidazole, and supportive treatments such as fluid supplement and correction of water electrolyte disorders. The laboratoty tests the next day showed that the patient′s blood LPS was 3-332-U/L and AMS was 139-U/L. The acute pancreatitis was considered to be related to azathioprine tablets. Then the drug was stopped and other treatments were continued. The patient′s symptoms improved quickly. Four days later, LPS was 546-U/L and AMS was 49-U/L.
  • 病例报告
    Yang Chunyan;Yao Shuqin
    . 2008, 10(1): 0-0.

    An 82yearold man with pulmonary infection received IV piperacillin/tazobactam 4.5 g mixed with 100 ml of sodium chloride 0.9% once every 8 hours. He developed dark red loose stools with occult blood of (++++) on the next day. Laboratory test revealed that his prothrombin time (PT) was increased from 11.3 s to 15.8 s, and his prothrombin activity (PA) was decreased from 140.9% to 76.9%. Despite treatment with IV etamsylate, IV aminomethylbenzoic and IM vitamin K1, his bloody stools remained unchanged on day 3. Piperacillin/tazobactam was discontinued and replaced with ciprofloxacin and azithromycin for antiinfective therapy. One day later, his stools almost returned to normal color. On reexamination, occult blood in stool was negative, and his PT and PA levels were within normal ranges.

  • 病例报告
    He Baoyu;An Weihong;Zhu Xi;Wang Haixia
    . 2008, 10(1): 0-0.

    A 64yearold woman with malignant pleural mesothelioma received the second injection of IV pemetrexed 0.5 g under chemotherapy. Two to six days after the therapy, she developed anorexia, nausea, vomiting, and diarrhea. The symptoms were not relieved after she took berberine hydrochloride. On admission, her body temperature was 38.5 ℃, her heart rate was 130 beats/min, and her blood pressure was 75/40 mmHg. An ECG showed frequent atrial premature beats and occasional ventricualr premature beats. A blood routine test showed a WBC count of 2.4×109/L, a RBC count of 2.14×1012/L, a Hb level of 65 g/L, and a PLT count of 13×109/L. A stool analysis detected 02 RBCs per highpower field and 47 WBCs per highpower field, and an occult blood test was positive. Blood biochemistry examination revealed the following values: LDH 204 U/L, TBil 39.4 μmol/L, BUN 24.0 mmol/L, and Cr 239 μmol/L. Her prothrombin time (PT) was 19.5 seconds, her prothrombin activity (PTA) was 41%, and her activated partial thromboplastin time (APTT) was 58.7 seconds. Arterial blood gas analysis revealed a pH of 6.91 and a paCO2 of 37 mmHg. She received tracheal intubation and mechanical ventilation immediately. Supplement of albumin and plasma, and antiinfective therapy, antishock, and antiarrhythmia treatment were given. On day 2 after admission, the patient's condition worsened. She presented with deep coma, oliguria, and a great quantity of ascites. It was hard to maintain adequate blood pressure. Sustained hemofiltration and rhG-CSF were administered. On day 3, the patient died of multiorgan failure.

  • 病例报告
    . 2006, 8(5): 385-386.
  • 国外文献题录
    . 2003, 5(4): 274-275.
  • 病例报告
    . 2001, 3(3): 197-198.
  • 不良事件
    . 2005, 7(2): 94-94.
  • 病例报告
    . 2000, 2(2): 120-121.
  • 安全信息
    . 2011, 13(2): 133-1.
  • 病例报告
    GAO Ren;REN Ai-min;SHEN Shu-feng;LIU Hong;XIAN Dong-mei
    . 2012, 14(4): 257-2.
    A 27-year-old female received an injection of carboprost tromethamine 250 μg into the uterine muscle for postpartum hemorrhage. Five minutes later, she abruptly developed chest distress, chest pain, and palpitation. An IV infusion of dexamethasone, ephedrine, and methylprednisolone were given. Her symptoms did not improve and progressed to hidrosis and confusion. ECG monitoring revealed increased T-wave amplitude, and her blood pressure decreased to 70/40 mm Hg. Anaphylactic shock was diagnosed. Nitroglycerin and anti-allergic treatment were given. Three hours later, her anaphylactic symptoms gradually improved, and her blood pressure increased to 100/60 mm Hg.
  • 病例报告
    HUANG Xu;ZHAO Yi;LI Xiao-xia
    . 2012, 14(4): 260-03.
    A 53-year-old woman with rheumatoid arthritis was treated with prednisone acetate, diclofenac sodium, tripterygium glycosides, and leflunomide. Later, sulfasalazine was added to her treatment regimen due to poor control of her diseases. The dose of sulfasalazine was initially 0.25 g twice daily, followed by 0.25 g thrice daily one week later and 1.0 g twice daily four weeks later. After six weeks of sulfasalazine treatment, the patient’s white blood cell and neutropil counts decreed from 6.5×109/L and 4.56×109/L to 1.6×109/L and 0.45×109/L,respectively. Sulfasalazine, diclofenac sodium, tripterygium glycosides, and leflumomide were discontinued immediately, and granulocyte colony-stimulation factor, imipenem/cilastatin sodium, mad fluconazole were given. Her white blood cell and neutrophil counts were 5.5×109/L and 2.86×109/L one week after sulfasalazine withdrawal as well as 6.4×109/L and 2.53×109/L two weeks after sulfasalazine withdrawal, respectively. Subsequently, the patient’s white blood cell and neutrophil granulocyte counts were within normal range,despite receiving diclofenac sodium, tripterygium glycosides, and leflunomide in succession.
  • ADR咨询
    . 2003, 5(4): 278-278.
  • ADR咨询
    . 2003, 5(3): 209-209.
  • 安全信息
    . 2007, 9(1): 67-67.
  • Li Siyan, Wu Shiqi, Zhang Qingxia
    Adverse Drug Reactions Journal. 2024, 26(7): 423-430. https://doi.org/10.3760/cma.j.cn114015‑20231113‑00801
    Objective To understand the safety research status of high‑alert medications (HAM)at home and abroad. Methods Literature related to HAM published in Chinese and English in CNKI andWeb of Science databases were searched and imported into CiteSpace 6.1.R6 software. The authors, institu‑tions, and keywords of the included literature were analyzed quantitatively to form visual network maps.Results A total of 992 literature in Chinese and 612 literature in English were included. The number ofliterature in Chinese has increased rapidly since the first relevant article in 2009, reached the peak numberin 2019, and then decreased in the past 3 years. The first paper in English was published in 1991, and theliterature number has shown a slow and continuous upward trend since then. Among literature in English,the United States made the most contribution to the development in research field of AHM (233 articles,38.1%) and had the greatest influence (node centrality 0.73). The institutions contributed the most in thenumber of relevant publications in Chinese and English were the Pharmacy Department of Peking University·423·药物不良反应杂志 2024 年7月第 26 卷第7期 ADRJ,July 2024, Vol. 26, No. 7Third Hospital (11 articles) and Harvard Medical School (10 articles), respectively. However, compared withpapers in English, there was less cooperation between the authors or their institutions of those in Chinese.The results of keywords analysis showed that papers in Chinese usually focused on the management of HAM,while those in English focused on the research of HAM‑related medication errors and adverse drug events; inrecent years, the research focuses in Chinese papers were patient satisfaction and management quality, whilethe English papers paid more attention to the clinical research on medication risks of HAM and drug safety.Conclusions The research on HAM in China started late, but developed rapidly. Compared with the litera‑ture in English, the influence of research in China is not enough, and there is a lack of cooperation betweeninstitutions or authors. The Chinese researches mainly focus on the management of HAM, and the clinicalresearches on the risks of different HAM and the prevention strategies of medication errors are relativelyinsufficient.
  • Liu Hongming, Wang Jian, Ding Zheng
    Adverse Drug Reactions Journal. 2022, 24(1): 44-46. https://doi.org/10.3760/cma.j.cn114015-20210318-00323
    A 64-year-old male patient underwent laparoscopic radical cystectomy for bladder squamous cell carcinoma, followed by anticoagulant therapy with subcutaneous injection of dalteparin sodium injection 5 000 U once daily. On the 8th day of dalteparin sodium treatment, the patient developed thrombocytopenia [platelet count (PLT) decreased from 132×109/L before operation to 65×109/L after operation]; on the 10th day, the patient developed weakness, swelling, and low skin temperature and cyanosis in the left thigh. Laboratory tests showed PLT 22×109/L and positive serum heparin/platelet factor 4 complex antibody. CT angiography of the left lower limb showed thrombosis of the left arteria iliaca communis.  Heparin-induced thrombocytopenia with thrombosis was diagnosed. Dalteparin sodium was discontinued and replaced by subcutaneous injection of fondaparinux sodium 7.5-mg once daily. Two days later, the swelling in the left thigh was relieved and PLT was 62×109/L; 8 days later, the swelling of left lower limb subsided and PLT was 128×109/L; 18 days later, CT angiography of the left lower limb showed that the location of thrombus in the left arteria iliaca communis was partially recanalized and PLT was 185×109/L.
  • Zhang Di1, Chen Siying1,Yang Zhihua1, Lu Wanhong2, Dong Yalin1
    Adverse Drug Reactions Journal. 2019, 21(1): 15-19. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.004
    ObjectiveTo analyze the rationality of antihyperuricemic drugs application and HLA-B* 5801 alleles detection in patients with chronic kidney diseases complicated by hyperuricemia.MethodsThe medical  records of patients with chronic kidney diseases complicated by hyperuricemia in the First Affiliated Hospital of Xi′an Jiaotong University from July 2015 to June 2017, whose HLA-B*5801 alleles were detected and who were treated with benzbromarone, allopurinol, or febuxostat, were collected and analyzed retrospectively. The evaluation criteria of rationality of 3 antihyperuricemic drugs application and gene detection were constituted according to the related guidelines, expert consensuses, and drug labels. It was judged as irrational use of benzbromarone in patients with estimating glomerular filtration rate (eGFR) <30 ml/(min·1.73 m2), excessive uric acid production, acute gout attack, urinary calculi, or undetermined uric acid excretion type. It was judged as irrational use of allopurinol in patients whose eGFR were <15 ml/(min·1.73 m2) but without dialysis or in patients with positive HLA-B*5801 alleles. It was judged as irrational use of gene detection in patients who had underwent gene detection but were not suitable for allopurinol treatment after initial assessment, and in patients who finally were not given allopurinol though they were suitable for allopurinol treatment after initial assessment and with negative HLA-B*5801 alleles.ResultsA total of 201 patients enrolled in the study. There were 57, 103, and 41 patients receiving benzbromarone, allopurinol, and febuxostat, respectively. There were 24 (11.9%) patients with positive HLA-B*5801 alleles and 177 (88.1%) with negative one. The percentages of patients with rational use of benzbromarone, allopurinol, and febuxostat were 40.4% (23/57), 76.7% (79/103) and 100% (41/41), respectively. The percentage of patients with rational use of HLA-B*5801 alleles detection was 50.2% (101/201). There were 100 patients with irrational use of HLA-B*5801 alleles detection, including 34 patients who underwent gene detection but were not suitable for allopurinol treatment [their eGFRs were<15 ml/(min·1.73 m2) but they did not conduct dialysis], and 66 patients who were not given allopurinol despite that they were suitable for allopurinol treatment with negative HLA-B*5801 alleles.ConclusionsThere are irrational use of both antihyperuricemic drugs and HLA-B*5801 alleles detection in patients with chronic kidney diseases complicated by hyperuricemia in our hospital. Irrational use of benzbromarone is more serious in antihyperuricemic drugs. Clinicians should pay attention to the irrational use of antihyperuricemic drugs.
  • . 2016, 18(2): 160.
  • Han Mei, Ge Ming, Li Wei
    . 2016, 18(4): 295.
    A 62-year-old male patient with gastric cancer was treated with an IV infusion of oxaliplatin (0.2 g, the first day) combined with oral tegafur, gimeracil and oteracil potassium (60 mg twice daily, the first day to the 14th day), the chemotherapy cycle was 21 days. On day 8 of the second cycle, the patient presented with massive erythema on face, neck and chest, accompanied by itching and pain. Hand-food syndrome induced by tegafur, gimeracil and oteracil potassium was considered. The patient and family refused to replace the chemotherapy regimens. On day 3 of the third cycle, the patient presented with new erythema and blisters on his face, truck and limbs. The patient was diagnosed as Stevens-Johnson syndrome. He was treated with intramuscular injection of diphenhydramine 20 mg once daily and topical application of Binghuang Fule ointment (冰黄肤乐软膏) twice daily. After eight cycles of chemotherapy, the skin lesions were significantly improved and regenerated skin was observed.
  • Zhao Jiali,Chen Qiuhong,Zhan Zhihong
    . 2016, 18(3): 228.
    A 61-year-old female patient received treatments with cefminox sodium, etimicin, Zhikang Capsules (致康胶囊), hemocoagulase, carbazochrome sodium sulfonate, acetyl cysteine, bromhexine hydrochloride for injection, and spleen aminopeptide oral lyophilized powder for hemoptysis and bronchiectasis with infection. On day 2 of carbazochrome sodium sulfonate treatment for 20 minutes, the patient developed rigidity of the back of her neck and headache. No special treatment was given. On day 3 after carbazochrome sodium sulfonate treatment for 15 minutes, above mentioned symptoms appeared again and aggravated. Carbazochrome sodium sulfonate was stopped at once and rotundine and flunarizine were given. About 45 minutes later, the headache was relieved. It was considered that the headache was caused by carbazochrome sodium sulfonate. After that, other treatments continued and  above mentioned symptoms did not recur.
  • Chen Yuanna, Ma Weicheng, Dong Yongquan
    . 2016, 18(5): 369.
    A-33-year-old man with bronchial asthma received budesonide and formoterol fumarate powder for inhalation one suction twice daily (one suck containing budesonide 160 μg and formoterol 4.5 μg). After 6 days of treatment, he developed the symptoms of fever (temperature of 38.2 ℃), headache, nasal obstruction, runny nose and sneeze. He took paracetamol, pseudoephedrine hydrochloride, dextrome-thorphan hydrobromide and chlorphenamine maleate one tablet thrice daily by himself. Two days later, the body temperature returned to normal and the headache was relieved. The follow day, paracetamol, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate was stopped, the nasal obstruction and runny nose slightly better but continuous. The budesonide and formoterol fumarate powder for inhalation was discontinued after one month because of the patient absent re-visiting in time. The symptoms of nasal obstruction and runny nose were relieved in the second day and disappear in the third day. The patient was using the drug again at intervals of 3 days, the flu-like symptoms recurred in 30 minutes and the body temperature reached 38.8 ℃. Drug-induced flu-like syndrome was considered. Budesonide and formoterol fumarate powder for inhalation was stopped and changed to salmeterol xinafoate and fluticasone propionate powder for inhalation. Loratadine and acetaminophen were given. The flu-like symptoms did not recur during four weeks of follow-up.
  • Yang Jianhui, Chen Yao
    . 2017, 19(5): 392.
    A 37-year old female with endodontitis received metronidazole 0.4 g three times daily and cefuroxime axetil 0.25 g twice daily according to the doctor′s advice. Three days after medication, the patient developed pain and ulcers on her oral cavity and lingual mucous membrane. The doctor was informed that the patient had the experience of oral ulcer 16 months ago by inquiring medical history. She received metronidazole for 3 days because of endodontitis, and then developed the oral ulcer. She was diagnosed as oral cavity and lingual mucous membrane ulcer induced by metronidazole. Metronidazole and cefuroxie axetil were stopped. She received the treatments with vitamin B complex tablet orally and topical application of oral ulcer paste. One week later, the ulcer was healed mainly.
  • WHO信息
    . 2004, 6(5): 351-351.
  • 病例报告
    Xu Yuhua
    . 2008, 10(5): 0-0.

    A 65-year-old woman took reserpine 0.5 mg/d for hypertension three years ago. After two weeks of treatment, she developed dark urine, yellowish of sclera and skin with pruritus. Laboratory investigation revealed the following:ALT 1 859 U/L,AST 1 441 U/L,total bilirubin 306.71 μmol/L,direct bilirubin 279.6 μmol/L,AFP 157.5 μg/L; HBsAb was positive and serologic test for hepatitis A, C, E were negative. Her CT examination showed cholecystitis. The patient had no history of hepatobiliary diseases. Various types of viral hepatitis and hepatic tumor were excluded by examination, and no evidence showed bacterial infection, so reserpineinduced reactions were suspected. After resepine was withdrawn and reduced glutathione and diammonium glycyrrhizinate were administered for 1 month, her symptom improved gradually; her liver function normalized; her cholecystitis disappeared. One month later, her AFP level also returned to normal range. One year ago, the woman took 1 tablet of compound reserpine and triamterene (containing 0.1 mg of reserpine per tablet) once daily for poorly controlled hypertension. After three weeks of therapy, similar symptoms reappeared and liver function test values and AFP increased again. In addition, CT scanning revealed cholecystitis again. Compound reserpine and triamterene was stopped. Liver-protective and anti-infective treatment were given. One month later, her liver function normalized and her cholecystitis disappeared again. The above-mentioned symptoms did not recur during one year of follow-up.

  • 中药不良反应
    Wei Kaijun;Zhang Yanguo;Wang Xiaoxia
    . 2008, 10(1): 0-0.

    A 48 yearold man with psoriasis had been treated for one year with Ciguyinxie capsules No.1 (four capsules daily in the morning), Ciguyinxie capsules No.3 (four capsules daily at night), and Cigukangfubao patches(The main ingredient of the three preparations is pseudobulb of appendiculate cremastra). The patient was hospitalized with aggravated psoriasis. Blood routine test revealed a WBC count of 3.2×109/L, a PLT count of 50×109/L, and a HB level of 90 g/L. On the second hospital day, a reexamination showed that his WBC count, PLT count, and HB level were decreased to 2.6×109/L, 19×109/L, and 82 g/L, respectively. Ciguyinxie capsules and Cigukangfubao patches were discontinued and the patient received recombinant human granulocyte stimulating factor, dexamethasone and platelet suspension. Three days later, his blood routine values returned to normal limits.

  • 安全信息
    . 2009, 11(4): 301-1.
  • 病例报告
    . 2005, 7(6): 455-456.
  • Chen Gang
    . 2017, 19(5): 393.
    A 70-year-old male with advanced lung cancer received gefitinib 250 mg once daily orally. Previously, the patient underwent aortic valve replacement and coronary artery bypass grafting because of valve insufficiency. He took warfarin (2-3 mg/d) normally for a long time after the operations. His international normalized ratio (INR) fluctuated between 1.5 to 2.1. One month after taking gefitinib,the patient′s INR increased to 4.4,he did not receive any other drugs at the same time. The elevation of INR was considered to be associated with the combination of warfarin and gefitinib. Gefitinib was withdrawn and the dose of warfarin was reduced to 1.5 mg/d. Three days later, his INR declined to 2.9.
  • He Yan, Cao Deping, Chen Fen
    . 2017, 19(2): 145-147.
    A 26-year-old female patient with excision of left breast fibroma received an IV infusion of lappaconite hydrobromide 8 mg in glucose and sodium chloride 500 ml once daily. No abnormality was found for the first time. About 20 minutes after IV infusion on the next day, the patient developed dry throat, slight dyspnea. Her respiratory rate was 25 times/min, heart rate was 55 beats/min and blood pressure was 70/55 mmHg. Lappaconite hydrobromide was discontinued immediately. She was given oxygen inhalation of 2 L/min, intravenous injection of adrenaline 0.5 mg, intravenous injection of adrenaline 10 mg, intramuscular injection of diphenhydramine 20 mg and IV infusion of dopamine 200 mg. After 5 minutes, the patient lost consciousness, had weak breathing, facial cyanosis and no pulsate. The electrocardiogram monitor displayed isoelectric line. The patient was treated with cardiopulmonary resuscitation, endotracheal intubation and ventilator support, chest compression, intravenous of epinephrine and infusion of hydrocor-tisone. The pathogenetic condition was getting worse progressively. The patient eventually died after 3 hours rescue.
  • Miao Di, Liao Limin
    . 2015, 17(2): 134-137.
    Overactive bladder is a group of syndromes characterized by symptoms of urinary urgency, seriously affecting the quality of life of patients. Solifenacin succinate is a new generation of muscarinic acetylcholine receptor (M receptor) antagonist with high selectivity for detrusor, and it can not only obviously relieve the symptoms of urgency and incontinence, increase urination and reduce micturition frequency, but also improve lower urinary tract symptoms for patients after implantation of ureteral stents. The main adverse reactions of M receptor antagonist are dry mouth, cognitive impairment and urinary retention. Compared with oxybutynin and tolterodine, the incidences of dry mouth and urinary retention caused by solifenacin succinate are low, and it also has less effect on cognitive function. But for the patient with high risk factors (such as combined use of other anticholinergic drugs and changes of blood brain barrier caused by primary diseases) and elderly patients with a history of cognitive impairment can induce or worsen the risk of cognitive impairment. During the first month of taking solifenacin succinate, more attention should be paid on the changes of residual urine volume in order to reduce the risk of acute urinary retention.
  • ADR咨询
    . 2004, 6(4): 277-277.
  • 专家论坛
    . 2012, 14(1): 8-2.
  • 病例报告
    He Yan;Xin Huawen;Li Qing
    . 2011, 13(1): 58-2.
    A 63yearold woman selfadministered one capsule of Move Free Advanced twice a day for cervical spondylosis and periarthritis of the shoulder. A total of 99 capsules was taken, during the administration period of one month and more, the patient developed yellowish skin and dark urine, accompanied by fatigue, nausea, and loss of appetite. Laboratory tests showed the following: ALT 322 U/L, AST 1108 U/L, TBil 133 μmol/L, and DBil 85 μmol/L. Move Free Advanced was discontinued and liverprotective treatment was given. However, her jaundice remained and she was hospitalized. The patient received entericcoated adenosyl methionine for 20 days. Her liver function tests revealed the following values: ALT 102 U/L, AST 89 U/L, TBil 604 μmol/L, and DBil 271 μmol/L. Severe druginduced liver damage was diagnosed. She received plasma exchange, followed by L-ornithine-L-aspartate, ursodeoxycholic acid, and albumin. Five months later, repeat liver function tests showed the following levels: ALT 21 U/L, AST 50 U/L, TBil 134 μmol/L, and DBil 70 μmol/L, and the patient’s condition improved markedly.
  • Wang Bing, Wang Quan, Sui Xiaojing, Li Jinfeng, Cui Yingjie, Zhang Yuan
    Adverse Drug Reactions Journal. 2024, 26(10): 636-638. https://doi.org/10.3760/cma.j.cn114015-20231117-00816
    A 67-year-old male patient with esophageal cancer received sintilimab and chemotherapy [sintilimab injection 200 mg by IV infusion, 1 day before chemotherapy, paclitaxel (albumin bound) 200 mg by IV infusion on day 1 and 300 mg on day 5, and nedaplatin 80 mg by IV infusion on day 1 and 70 mg on day 2, 21 days as 1 cycle] for 4 cycles. Later, due to mediastinal lymph node metastasis, the patient received sintilimab and palliative radiotherapy one time. Eight days later,the patient developed urinary frequency, urgency and pain, urine routine showed 638 red blood cells/μl, and 2 141 white blood cells/μl. The T-cell test for mycobacterium tuberculosis infection was positive, and cystoscopy showed diffuse redness and swelling of bladder mucosa. The patient was diagnosed with immune-related cystitis and bladder tuberculosis, which was considered to be related to sintilimab. Methylprednisolone sodium succinate and anti-tuberculosis treatment were given. After 5 days of treatments, the patient′s aforementioned symptoms were improved and the urine routine returned to normal. Afterwards, sintilimab was not used again and relevant symptoms did not recur.
  • Adverse Drug Reactions Journal. 2024, 26(1): 33-37. https://doi.org/10.3760/cma.j.cn114015-20230724-00551
    Objective To mine and evaluate the adverse reaction risk signals of omeprazole, and provide reference for the safe application of the drug. Methods Data cleansing on all adverse reactions of omeprazole collected in the Shandong Provincial Center for Adverse Drug Reaction Monitoring database from January 2018 to December 2021 was performed, and information on patients′ gender, age, drug administration routes, and the systems/organs involved, clinical manifestations, and outcomes of adverse reactions was collected. The risk signals of adverse reactions associated with omeprazole were mined and evaluated using reporting odds ratio (ROR), proportional reporting ratio (PRR), and Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard methods. The risk signal judgment criteria for ROR and PRR methods were the number of reports ≥3, and the lower limit of 95% confidence interval (CI) of ROR or PRR>1, and that of MHRA method was the number of reports≥ 3, PRR≥2, and χ2≥4. Results A total of 2-706 adverse reaction reports with omeprazole as suspect drug were entered, including 234-severe adverse reactions (8.7%). Of them, 1-270 were male (46.9%) and 1-432 female (52.9%); the median age was 58 years, including 86 patients under 18 years old, 1-417 cases between 18-60 years old, and 1 203 cases over 60 years old. A total of 17-systems or organs were involved in adverse reaction related to omeprazole, and the top 5 were gastrointestinal system [1-412 cases (37.6%)], skin and its accessories [883 cases (23.5%)], nervous system [716 cases(19.1%)], respiratory system [269 cases (7.2 %)], and systemic system [207 cases (5.5%)]. The median occurrence time of adverse reactions from medication was 30-minutes, and 1 710 cases (63.2%) occurred within 1 day after medication. After treatments, 1-595 patients (58.9%) recovered, 1 098 patients (40.6%) were improved, and no deaths were reported. Twenty-seven risk signals were mined by ROR and PRR methods, respectively, and 21 by MHRA method. The top 5 adverse reactions in signal intensity mined using the ROR method were gastrointestinal bloating, headache, constipation, tongue numbness, and joint pain; the top 5 adverse reactions in signal intensity mined using the PRR method were gastrointestinal bloating, headache, constipation, tongue numbness, and dizziness; the top 5 adverse reactions in signal intensity mined using the MHRA method were gastrointestinal bloating, headache, constipation, bloating, and dry mouth. Among them, the signals not mentioned in the labels were chest tightness, chills, cyanosis, mouth numbness, overall trembling, and tongue numbness. Conclusions The adverse reactions of omeprazole involve multiple systems/organs, and common adverse reactions include gastrointestinal bloating, headache, constipation, etc. Risk signals such as chest tightness, chills, cyanosis, numbness of the mouth, trembling of the whole body, and numbness of the tongue are not recorded in the labels, which should be vigilant and intervened in time in clinics.
  • Xu Qingjie, Chen Yan, Zhang Manka, Li Zhouping, Liu Yin, Tang Ming, Rao Zhiguo, Ma Runlin, Xue Xiaoyan
    Adverse Drug Reactions Journal. 2023, 25(12): 732-738. https://doi.org/10.3760/cma.j.cn114015-20230227-00119
    Objective To observe the effect of methylprednisolone (MP) combined with cyclophosphamide (CTX) on inflammation and immune cell activity in bleomycin (BLM)-induced pulmonary fibrosis rat model. Methods Forty healthy 6 to 8-week-old SD rats were randomly divided into blank control, BLM model, BLM+MP, and BLM+MP+CTX groups, with 10 rats in each group. The rat model of pulmonary fibrosis was prepared by intratracheal infusion of BLM (5-mg/kg, only once). From the 7th day of modeling, MP (3-mg/kg) was injected in rats in the BLM+MP group and MP (3-mg/kg)+CTX (8-mg/kg) was injected via tail vein in rats in the BLM+MP+CTX group, once daily for 21 days. The degree of lung inflammation and fibrosis in rats was detected using HE and Masson staining methods. The numbers of granu- locytes and neutrophils in bronchoalveolar lavage fluid (BALF) and blood T cell subsets in rats were detected using flow cytometry. Results On the 7th day of modeling, the external morphology, HE and Masson staining results of rat lung tissue showed that BLM-induced pulmonary fibrosis model was successfully prepared. On the 28th day of modeling, the lung tissue structure of the BLM group was disordered with obvious collagen deposition, the number of granulocytes and neutrophils in BALF increased significantly, the proportion of blood T cells, CD4+ T cells, and regulatory T cells (Tregs) decreased, the proportion of CD8+ T cells, and the CD4+/CD8+ T cells ratio decreased significantly (all P<0.05). Compared with the BLM group, the degree of pulmonary fibrosis in the BLM+MP+CTX group was improved significantly, the number of granulocytes and neutrophils in BALF decreased significantly, the proportion of blood T cells, CD4+ T cells and Tregs cells increased significantly, the proportion of CD8+ T cells decreased, and the ratio of CD4+/CD8+ T cells increased significantly (all P<0.05). The improvement effect in rats of BLM+MP+CTX group was better than that of BLM+MP group, and the difference was statistically significant (P<0.05). Conclusion MP combined with CTX can reduce the degree of inflammatory reaction in rats with pulmonary fibrosis and improve T cell immune activity.
  • Zheng Juanjuan, Liu Xinyuan, Li Bingqing, Xu Jing, Li Xiaoyu
    Adverse Drug Reactions Journal. 2023, 25(6): 371-373. https://doi.org/10.3760/cma.j.cn114015-20220930-00888
    A 70-year-old male patient suddenly developed itching all over the body, severe chest pain, and radiating pain in the left upper limb, accompanied by urticarial, 4 hours after endoscopic polypectomy of colon and during the intravenous infusion of 5% glucose injection. His blood pressure was 85/50-mmHg, heart rate was 95-106 beats/min, and the heart rhythm is absolutely irregular. Electrocardiogram showed ST segment elevation in leads V2~V6. Coronary angiography showed an occlusion in the middle segment of the left anterior descending artery, and one stent was implanted after aspiration of the thrombus. Then his symptoms were improved. On day 12 after endoscopic polypectomy of colon, the patient suddenly lost consciousness and blood pressure could not be measured one minute after subcutaneous injection of sulfoda hepatokitae sodium 1.5-mg. Anaphylactic shock was considered. After receiving antiallergic, raising blood pressure, and enhancing cardiac function treatments, the patient′s consciousness and blood pressure restored. On day 14 after endoscopic polypectomy of colon, the patient developed pruritus, rash, chest tightness, suffocation, and decreased blood pressure after the 6th intravenous injection of tolasemide 10-mg for 5-minutes. Immediate antiallergic treatments were given and the symptoms were improved. Combined with the history and skin prick test results, the patient was considered to have repeated attacks of type II Kounis syndrome.
  • Zhou Jia, Jin Lei, Bu Shuhong, Yuan Xiyue
    Adverse Drug Reactions Journal. 2024, 26(5): 268-274. https://doi.org/10.3760/cma.j.cn114015-20231204-00860
    Objective To understand the pre-warnings of contraindicated drugs in medical advices in patients with renal insufficiency by the pre-audit system. Methods The pre-warnings of contraindicated drugs in medical advices in patients with renal insufficiency by the pre-audit system in Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from January 1, 2021 to December 31, 2021 were collected. The drugs involved were analyzed and determined as drugs in the correct pre- warnings and drugs in the audit rules that needed to be corrected. The drugs involved in the correct pre- warnings and the acceptance of pre-warnings by clinicians were analyzed; drugs that can be used off-label according to the evidence-based information were recorded and the proposed suggestions on the revision of the audit rules were provided. Results A total of 259 medical advices about pre-warnings related to contraindicated drugs in patients with renal insufficiency were included in the analysis, involving 47 drugs. Among the 259 pre-warnings, 169 were correct, with the correct rate of 65.25%, and 107 (63.31%) of them were accepted by clinicians. The rate of acceptance by surgeons was higher than that by physicians, and the difference was statistically significant [76.39% (55/72) vs. 53.61% (52/97), P<0.01]. The audit rules in the 90 pre-warnings that needed to be modified involved 12 drugs. Of them, one drug (dapagliflozin tablets) had updated instruction, thus the rules can be modified directly according to it. The other 11 drugs were recorded for off-label drug use in the system based on evidence-based information, and of them, pre-warning levels were adjusted for 6 drugs, and audit rules were adjusted for 5. Conclusions The pre-audit system can effectively pre-warning the contraindicated drug prescriptions of CKD patients, and the correct rate of pre-warning and clinician acceptance rate are more than 60%. The audit rules of some pre-warnings need to be adjusted with the update of the instructions and additional evidence-based information for off- label drug use after recording.
  • Luo Man, Yang Yan
    . 2015, 17(2): 148-149.
    Patient 1, a 69-year-old male with chronic myelocytic leukemia received hydroxycarbamide 1.0 g/d. The refractory ulcer developed on his lateral malleolus in left foot one year later and lasted for 5 years. Physical examination showed the ulcer's area was 8 cm×6 cm. The yellow necrotic tissue adhered to the surface of ulcers. The edema, erythema and severe tenderness appeared in surrounding skin of ulcers. He was given an IV infusion of piperacillin sodium and sulbactam sodium 3.0 g twice daily for 10 days. The patient received an operation of debride +vacuum sealing +autologous skin graft on day 10 and 35 of hospitalization, respectively. But the necrosis in skin graft appeared on the fourteenth day after the first operation and the tenth days after the second operation, respectively. The patient gave up the treatment and were discharged. Patient 2, an 80-year-old male with chronic myelocytic leukemia received hydroxycarbamide 1.0 g/d. The refractory ulcers developed on his right and left heels one year later and lasted for one year. Physical examination showed that the maximal ulcer's area was 6 cm×4 cm. There were yellow necrotic tissue adhering to the surface of ulcers without granulation tissue. The edema, erythema and severe tenderness were found in the surrounding skin of ulcers. He was given an IV infusion of piperacillin sodium and sulbactam sodium 3.0 g twice daily and a  combined interactive Ag dressing ( HARTMANN, Germany) on the surface of ulcers once daily. The patient felt the pain decreased 24 hours later. On day 5, new granulation tissue appeared on the surface of a wound, and the necrotic tissue fell off. On day 15, epithelialization appeared on the surface of the wound. On day 40, scar formation on the surface of the wound appeared and the patient was discharged. The two patients continued to take the hydroxycarbamide according to the original dose during the process of treatment of ulcer.
  • Zhu Yuanchao, Chang Jianmin, Hu Xin
    The target of epidermal growth factor receptor inhibitor (EGFRI) is epidermal growth factor receptor (EGFR). EGFRI can block the activation and signal transduction of EGFR in tumor cells, inhibit the proliferation of tumor cells and induce apoptosis, thus having antineoplastic effect. EGFRIs are currently widely used as targeted anti-tumor drugs. EGFRI can act on skin keratinocytes, interfering with the growth, proliferation, differentiation, migration and adhesion of keratinocytes, causing growth arrest and premature differentiation of the keratinocytes in the basal layer, and often leading to adverse skin reactions. The incidence of EGFRI-related cutaneous adverse reactions was 40% to 90%. Common cutaneous adverse reactions include papulopustular rash, skin pruritus, dry skin, skin cracking, angiotelectasis, and changes of hair and nails. Most cutaneous adverse effects are reversible and dose-dependent. The incidence and severity of adverse skin reactions are closely related to the clinical efficacy of EGFRI. Therefore, the adverse skin reactions should be correctly recognized and should be managed separately  according to the severity of the reactions. In general, grade 1 and grade 2 adverse skin reactions need not withdrawal or dosage adjustment of EGFRI, but severe adverse skin reactions may affect the patients' quality of life, so EGFRI dosage should be reduced or discontinued, and EGFRI retreatment should be continued when the skin damage is improved.
  • Dai Chengjia, Li Hongna, Lin Xiaofeng, Lin Yan
    . 2018, 20(3): 237-238.
    A 40-year-old female patient was diagnosed as having left breast cancinoma and underwent modified radical mastectomy. The patient′s surgical procedure was uneventful and her vital signs were stable. After the operation, doxapram hydrochloride 100 mg injection  was given by intravenous injection (about 1 minute of completing the injection) to accelerate the patient recovering from the anesthesia. The patient developed shock about 5 minutes after the injection. Her blood pressure fluctuated between 60/46 and 74/54 mmHg, blood oxygen saturation fluctuated between 58% and 74%, and wet rales were audible over both lungs. The patient immediately received oxygen inhalation via a facemask and intravenous injection of adrenaline 40 μg, furosemide 40 mg, and dexamethasone 10 mg. In addition, dopamine 80 mg dissolved in 20 ml of 0.9% sodium chloride injection was administered intravenously via an infusion pump at a rate of 8 ml/h. Twenty minutes later, the patient′s moist rales in both lungs were significantly reduced, her blood pressure was 86/52 mmHg, and oxygen saturation fluctuated between 0.84 and 0.91. On postoperative day 2, the patient had blood pressure 110/70 mmHg, oxygen saturation 0.98, and heart rate 70-80 beats/min. Auscultation revealed the patient had coarse breath sounds in both lungs and slight moist rales were heard in her right lower lung. On postoperative day 5, the patient′s condition was stable and her wound healed well and then she was discharged.
  • Wang Han, Li Gen
    A 44-year-old female patient received combined chemotherapy of docetaxel and cyclophosphamide after undergoing a resection of invasive ductal carcinoma of her left breast. One day before each cycle of chemotherapy, the patient received oral dexamethasone 8 mg twice daily for 3 consecutive days to prevent docetaxel-induced anaphylaxis. No  adverse reactions appeared in the patient after the first cycle of chemotherapy. On the 5th day of the second cycle of chemotherapy, the patient was exposed to the sun for 30 minutes. The next day, urticaria appeared on her back of neck, opisthenar, knee, and waist. The patient did not receive any other drugs and she also did not change her dietetic habits during the period of chemotherapy. The rash was considered to be photosensitivity reaction possibly induced by docetaxel. The patient received antianaphylaxis treatment, including oral loratadine 10 mg and IV infusion of methylprednisolone sodium succinate 40 mg, calcium gluconate 2.0 g, and vitamin C 2.0 g once daily. Eight days later, the patient′s rash improved.
  • 不良事件
    . 2004, 6(2): 132-132.
  • 国外文献题录
    . 2003, 5(6): 417-418.
  • 病例报告
    Deng Yinghui;Zhao Yue
    . 2008, 10(1): 0-0.

    Two male patients, aged 43 years and 81 years, had a history of type 2 diabetes mellitus, diabetic nephropathy, and hypertension. Their blood pressure and blood glucose returned to normal limits after drug therapy. Sulodexide 50 to 100 mg twice daily was added to their regimens for proteinuria. After receiving a total dosage of sulodexide 300 to 400 mg, they began to experience diarrhea with watery stools every one to two hours. Abnormalities were not found on stool examination. Treatment with sulodexide was stopped, and diarrhea resolved soon. 6 days later, sulodexide 50 mg was administered to the 81yearold patient. Diarrhea recurred 2 hours after the administration. Sulodexide was discontinued, and the symptom was relived.

  • 国外文献题录
    . 2003, 5(2): 130-132.
  • Wang Yexin, Cheng Yuanyuan, Dong Jicheng, Sun Guoping, Lu Ying, Liang Xiaoling
    A 56-year-old male patient with undifferentiated type of schizophrenia received one disintegrating tablet of aripiprazole 10 mg orally once daily and the dose of the drug was increased to 30 mg once daily on day 21. Thereafter, the patient′s mental symptoms improved markedly. After receiving aripiprazole for 4 months, the patient developed difficulty in walking. Extrapyramidal symptoms (EPS) induced by aripiprazole was considered. The drug dose was reduced to 25 mg once daily, but the symptoms did not improve, subsequently, hypermyotonia, dysphagia, salivation, mask face, and urinary incontinence appeared. Although the dose of aripirazole was reduced to 5 mg once daily, it did not help to control EPS. Aripirazole was stopped, and 3 days later, the patient′s EPS became aggravated. Intravenous infusions of 0.9% sodium chloride injection 500 ml, IV vitamin C 2 g, IV vitamin B6 0.5 g as well as dextrose and sodium chloride injection 500 ml once daily were given to promote drug excretion. The next day, EPS relieved and on day 5, basically faded.
  • Li Xiao1, Liu Ruining2, Liu Zhijun1
    Adverse Drug Reactions Journal. 2019, 21(1): 43-49.
    Center for Drug Evaluation and Research of the Food and Drug Administration of the United States renewed the "clinical drug interaction studies-study design, data analysis, and clinical implications guidance for industry(draft guidance)" in 2017. In this paper, the importance of research on drug interaction of new drugs, reference drugs in research on drug interaction, research on interaction of anticipated clinical combination drugs, design and precautions of prospective research on drug interaction, research precautions of cytochrome P450-mediated drug interaction, research precautions of drug transporter-related drug interaction, other precautions on drug interaction research, description of drug interaction information in drug labels, and etc. were interpreted, so as to provide reference for rational drug use in clinical.
  • Adverse Drug Reactions Journal. 2019, 21(5): 323-325. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.003
    Medication safety is closely related to patient safety. Medication error (ME) is one of the common reasons of patient injury. ME can occur in the links of prescription (medical order) writing and delivery, the storage, dispensing, and distribution of drugs, drug administration and monitoring, medication guidance, drug management, information technology, and etc. Physicians, pharmacists, nurses, and patients are all the possible responsible persons for ME. Everybody should participate in the prevention of ME. In addition to solving the technical problems in management, it is also necessary to advocate a non-punitive medication safety culture and encourage physicians, pharmacists, and nurses to actively participate in the monitoring and reporting of ME. More efforts need to be done on the medication safety in China.
  • LAO Hai-yan;WAN Bo;YANG Min;LIU Shuang-xin
    A 72-year-old man received oral tacrolimus 2 mg twice daily and methylprednisolone 8 mg once daily for atypical membranous nephropathy. About six months later, the patient presented with anepithymia, dry mouth, and asthenia. Laboratory testing showed a fasting blood-glucose level of 23.2 mmol/L and a glycosylated hemoglobin level of 13.1%. The diagnose was considered more likely to be drug-induced secondary diabetes mellitus. Tacrolimus was stopped and changed to oral mycophenolate mofetil 500 mg every 12 hours. And methylprednisolone was continued according to the original dosage and telmisartan and insulin were given at the same time. Four days later, his glucose level became stable relatively.
  • ADR咨询
    . 2002, 4(2): 138-138.
  • Zhang Jianxiong, Chen Jingcheng, Li Jiangshuo, Li Lijun, Wu Xiaofang, Zhang Qiming, Dong Ruihua
    Adverse Drug Reactions Journal. 2023, 25(9): 551-555. https://doi.org/10.3760/cma.j.cn114015-20230612-00422
    Objective To explore the feasibility of pulse wave recording in the pharmacodynamics and safety evaluation in clinical trials of sedative-hypnotics. Methods The subjects were male healthy subjects who were publicly recruited by the research ward of Beijing Friendship Hospital, Capital Medical University from April 11 to June 11, 2022. The pharmacokinetic parameters of the single or combined use of midazolam were calculated based on the pharmacokinetic parameter analysis set. The occurrence of adverse events during the trial were recorded. Healthy subjects wore pulse wave recording watches for 24-hours in states of without medication, midazolam alone, and midazolam combined with itraconazole, and the subjects′ heart rate and body movement data were recorded, and pharmacodynamic evaluation indicators such as sleep duration, sleep depth and multiple dreams were compared with safety evaluation indicators such as mental state, circadian rhythm and life vitality. Results A total of 12-healthy male subjects were included, aged (34±6) years. When using midazolam alone, the median Tmax was 0.5-hour, Cmax was (19.10±5.35) μg/L, AUC0-t was (45.41±13.88) min·μg/L, and AUC0-∞ was (46.99±14.74) min·μg/L. After combination with itraconazole, the median Tmax was still 0.5-hour, Cmax was (61.05±19.0) μg/L, AUC0-t was (394.36±60.26) min·μg/L, and AUC0-∞ was (553.10±178.87) min·μg/L. The 90% confidence interval for the geometric mean ratio of the AUC0-t between midazolam combined with itraconazole and midazolam alone was 735.24% to 1-061.57%. Among the 12-subjects, 9 had a total of 26 adverse events, all of which were mild. The results of pulse wave recording showed statistically significant differences in sleep duration[(5.40±1.35), (6.50±1.85), and (8.05±0.8) hours, P=0.001], sleep depth [(14.13±5.15), (19.00±4.62), and (24.32±3.66) points, P=0.005] and life vitality[40.00(38.00,41.00), 36.50(35.25,38.75), and 32.50(30.00,36.00) points, P<0.001] in subjects in states of without medication, midazolam alone, and midazolam combined with itraconazole. Conclusion Pulse wave recording can be used for a real-time, objective, quantitative assessment of the pharmacodyna- mics and safety of sedative-hypnotics.
  • Zhao Hong, Liu Ligai, Sun Lei, Xie Wen
    Adverse Drug Reactions Journal. 2021, 23(8): 416-423. https://doi.org/10.3760/cma.j.cn114015-20210514-00562
    Objective To explore the clinical and pathological characteristics of Polygonum multiflorum-associated liver injury. Methods Medical record data of inpatients with Polygonum multiflorum-associated liver injury diagnosed by histopathological examination between January 2009 and December 2018 in Beijing Ditan Hospital, Capital Medical University were collected and analyzed retrospectively. According to the different processing methods of Polygonum multiflorum, the patients were divided into raw Polygonum multiflorum group and prepared Polygonum multiflorum group. The clinical and pathological characteristics in patients in the 2 groups were compared. Results A total of 22 patients entered the study. Of them, 8 patients were in the raw Polygonum multiflorum group, including 4 males and 4 females with a median age of 32 (25, 37) years; 14 patients were in the prepared Polygonum multiflorum group, including 2 males and 12 females with a median age of 51 (38, 58) years. Twenty one patients were clinically identified as hepatocellular injury type and one patient (raw Polygonum multiflorum group) was identified as mixed type, which all had varying degrees of acute hepatitis related symptoms. The median peak levels of alanine aminotransferase, aspartate aminotransferase, and total bilirubin in the raw Polygonum multiflorum group were significantly higher than those in the prepared Polygonum multiflorum group [1-832 (1-134, 2-301) U/L vs. 900 (456, 1-102) U/L, P=0.001; 1-135 (475, 1-408) U/L vs. 466 (240, 662) U/L, P=0.017; 212.1 (102.5, 363.4) μmol/L vs. 59.7 (17.7, 117.3) μmol/L, P=0.012]. The main pathological manifestation of liver injury in patients in the 2 groups was acute lobular hepatitis. After the occurrence of liver injury, all 22 patients discontinued Polygonum multiflorum preparation and were given symptomatic treatment, and all were improved and discharged after 9-37 d of hospitalization. After discharge, one patient lost the follow-up and the other 21 patients′ liver function recovered, with a median time to recovery of 3 (2, 6) months. Three patients′ abnormal liver function lasted more than 6 months and they were diagnosed with chronic hepatitis. Conclusions Polygonum multiflorum-associated liver injury is mainly hepatocellular injury type and the pathological feature is acute lobular hepatitis. The degree of liver injury caused by raw Polygonum multiflorum is more serious than that caused by prepared Polygonum multiflorum. After stopping Polygonum multiflorum and giving symptomatic treatment, most patients had a good prognosis.
  • Yu Chao, Wang Jun, Liu Jilu
    Adverse Drug Reactions Journal. 2021, 23(9): 495-497. https://doi.org/10.3760/cma.j.cn114015-20210105-00012
    A 77-year-old female patient received an IV infusion of ossotide injection 50-mg dissolved in 0.9% sodium chloride injection 100-ml once daily after spinal canal decompression, bone grafting, fusion, and internal fixation due to lumbar disc herniation. About 5-minutes on the first infusion of the drug, the patient complained of chest tightness, dyspnea, cold sweat, and upper abdomen pain; cyanosis, chills, and red rash with itching all over the body appeared. Her blood pressure was 74/45mmHg. Ossotide injection was discontinued immediately and intravenous injection of dexamethasone 10-mg, intramuscular injection of epinephrine 0.5-mg, fluid infusion, and oxygen inhalation were given. About 2 hours later, her blood pressure was 95/50-mmHg, red rash was subsided, but the abdominal pain, chest tightness, and shortness of breath were not relieved. The blood amylase level was 626-U/L. The chest and abdomen CT scan showed pulmonary edema and bilateral pleural effusion. Intravenous injection of methylprednisolone 40-mg, intravenous infusion of human serum albumin 20 g, continuous intravenous pumping of somatostatin 0.25-mg per hour, and fasting were given immediately. About 4 hours later, the blood pressure increased to 110/60-mmHg, and the abdominal pain, chest tightness, and shortness of breath were relieved. On the second day, the patient complained of abdominal pain, chest tightness, and shortness of breath again, blood amylase level was 915-U/L. Intravenous injection of methylprednisolone 40-mg once daily was given. And 2 hours later, these symptoms were relieved. On the 9th day, abdominal pain disappeared, blood amylase level was 68-U/L, chest CT showed no pulmonary edema, and her condition was stable.
  • He Na, Wu Ziyang, Zhai Suodi
    Adverse Drug Reactions Journal. 2024, 26(10): 584-587. https://doi.org/10.3760/cma.j.cn114015-20240806-00699
    Pre-marketing clinical trials may fail to detect rare or delayed adverse drug reactions (ADRs) due to insufficient sample size and short follow-up periods. Therefore, continuous post-marketing safety evaluation is necessary. Evidence generation relies on discovering ADR signals and conducting studies to verify specific risks. Integrating evidence from multiple sources through methods like meta-analysis can further enhance the comprehensiveness and reliability of drug safety evaluations. Additionally, risk management in clinical practice should be emphasized by developing standardized clinical guidelines and establishing decision support systems to facilitate the dissemination and application of evidence, ensuring its practical use. Constructing an evidence ecosystem not only helps identify and understand potential medication safety issues, but also enhance the scientific and practical aspects of risk management, ultimately reducing patient harm from ADRs.
  • 病例报告
    Li Jing;Zhao Min
    . 2011, 13(1): 54-2.
    A 71yearold woman received an IV infusion of adenosine cyclophosphate 40 mg in 0.9% sodium chloride 250 ml for her hyperthyroid heart disease. About five minutes after the infusion started, she experienced severe lumbago and palpitation, followed by bilateral palpebral oedema, chest distress and vomiting 30 minutes later. Her blood pressure was 180-190/100-105 mm Hg, and moist rales were heard in the lower lungs. Renal function tests showed the following values: occult blood (+++), protein (+++), and 1-2 RBC/high power field. Adenosine cyclophosphate was discontinued immediately and she received oxygen inhalation,dexamethasone, furosemide, omeprazole, and nifedipine. About two hours later, the patient urinated >1000 ml. She had a blood pressure of 159/65 mm Hg, an oxygen saturation 0.97, and a heart rate of 85 beats/min. Moist rales in both lungs reduced significantly. Three days later, the patient basically returned to normal.
  • Wang Liuqing, Xiao Yuelan, Zhang Shoucheng, Wang Hong
    A 26-year-old female patient received injections of botulinum toxin in a private clinic for cosmetology. One hundred units of botulinum toxin were injected firstly into the mandible, and then 200 units were injected into each gastrocnemius 14 days later. On day 2 after the second injection, the patient suffered from fatigue and oppression in chest, which did not affect her daily life. Above-mentioned symptoms aggravated 3 weeks later and even difficulty in walking and limbs lifting, bucking in drinking, and bilateral blepharoptosis appeared. She was admitted to hospital 4 weeks after the onset of the disease. Physical examination showed that the patient had bilateral blepharoptosis, difficulty in head-raising, grade 4, 5, and 3 muscle strength respectively in the proximal limbs, distal limbs, and lower extremities, and unable to stand up after squatting. Myasthenia gravis was considered. However, results of the prostigmin test and repetitive electrical nerve stimulation test did not support above diagnosis. Swelling in the patient′s lower jaw was found during the doctor′s regular ward rounds on day 4 after the admission and the diagnosis of botulinum toxin poisoning was confirmed by inquiring the history of disease. After 12 days of symptomatic treatments, the patient′s weakness of limbs and oppression in chest relieved, bilateral blepharoptosis markedly improved, and her muscle strength returned to normal basically.
  • Shi Yali, Ji Xing, Guo Huilei, Li Ying, Zhu Mingmei, Wang Xuan, Xu Jing
    Department of Pharmacy, Children′s Hospital Affiliated to Nanjing Medical University, Nanjing 210008, China (Shi YL, Ji X, Guo HL, Zhu MM, Wang X, Xu J); Department of Pharmacy, Beijing Children′s Hospital, Capital Medical University, Beijing 100045, China(Li Y)
    Corresponding author: Xu Jing, Email: njxujing@163.com【Abstract】ObjectiveTo investigate the risks of epinephrine use in children using healthcare failure mode and effect analysis (HFMEA) method.MethodsA project team was set up and data on adverse events of epinephrine use in children reported at home and abroad, data of medication errors in database of clinical medication safety monitoring network, and data from questionnaires and on-the-spot investigations were collected. Risk points in the process of epinephrine use were collected using HFMEA method. Severity (S), frequency of occurrence (O), and likelihood of detection(D) of risks were scored(the scores ranged from 1.0 to 5.0) and the risk priority numbers (RPN) were determined. The risk points with higher RPN scores or the score of severity up to 5.0 were screened out and the corresponding prevention strategies were formulated. ResultsThrough comprehensive evaluation on data from domestic and foreign databases and medication error databases in clinical medication safety monitoring network, as well as data from questionnaires and on-the-spot investigations, a total of 33 risk points in links of hospital information system, doctor prescribing, pharmacist dispensing, and nurse dispensing were obtained. Fourteen risk points with higher RPN scores and the score of severity up to 5.0 were screened out, including 2, 4, 4, and 4 risk points in links of hospital information system, doctor prescribing, pharmacist dispensing, and nurse dispensing, respectively. Fourteen preventive strategies corresponding to the risk points were established, including 6 mandatory, 4 recom-mended, and 4 conditional ones.ConclusionRisk points were found in the process of epinephrine use in children by HFMEA method and unified management standards were established.
  • Zhang Hanyu, Xie Miaorong, Wang Guoxing
    . 2017, 19(3): 208.
    ObjectiveTo evaluate the efficacy and safety of itraconazole on the advanced age patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) complicated with pulmonary fungal infection.MethodsBeijing Friendship Hospital information system was searched and the clinical data of patients with AECOPD complicated with pulmonary fungal infection who were hospitalized in Department of Emergency Medicine, Beijing Friendship Hospital from January 1st, 2013 to January 1st, 2016 were collected and analyzed retrospectively. The patients were divided into the  advanced age group (≥ 80 year-old) and the middle age group (40-60 year-old). The dosage regimen included IV infusion of itraconazole 200 mg once per 12 hours in the first 2 days, then 200 mg once daily until to the end of observation in the Department of Emergency Medicine or changed to take itraconazole orally for consolidation. The clinical efficacy rate, fungal clearance rate and incidence of adverse drug reactions (ADR) were compared between the patients in the 2 groups.ResultsA total of 132 patients were enrolled in the analysis. There were 60 and 72 cases in the advanced age group and the middle age group, respectively. The average time of using itraconazole in the advanced age group and the middle age group were (19±5)d and (16±3)d, the difference was statistically significant (P<0.01). The patients in the 2 groups received the symptomatic treatments which included meropenem or imipenem and cilastatin sodium for anti-infection, dyphylline for preventing asthma, and ambroxol hydrochloride for eliminating phlegm at the same time. The results of sputum culture showed that the case number of candida infection and aspergillus infection were 35 (58.3%) and 25 (41.7%) in the advanced age group, 48 (66.7) and 24 (33.3%) in the middle age group, respectively. At the end of intravenous medication of itraconazole, the body temperature, white blood cell count, and neutrophile granulocyte proportion in the 2 groups were lower than those before medication (all P<0.05), but the difference between them was not statistically significant (P>0.05). The proportion of cases with the symptoms or sign of cough, gasp for breath, and pulmonary rale in the 2 groups were lower than those before medication (all P<0.01), but the difference between 2 groups was not statistically significant (P>0.05). Imaging examination results were better obviously than those before medication, the difference was statistically significant (P<0.01). The clinical effective rate and the fungal clearance rate in the advanced age group and the middle age group were 78.3%(47/60) and 75.0%(45/60) , 80.6%(58/72) and 80.6%(58/72), respectively. The differences were not statistically significant (all P>0.05). One case in each group appeared gastrointestinal reactions on day 5 and 10 of IV infusion of itraconazole, respectively. The adverse reactions were disappeared on day 2 and 7 of symptomatic treatments, respectively. ConclusionItraconazole has an affirmatory curative effect and also is safe in treatment of advanced patient who with AECOPD complicated with pulmonary fungal infection.
  • SARS防治
    . 2003, 5(3): 150-150.
  • 安全信息
    . 2008, 10(3): 221-1.
  • ADR咨询
    . 2002, 4(6): 421-421.
  • Adverse Drug Reactions Journal. 2001, 3(4): 266-266.
  • 读者·编者·消息
    . 2003, 5(6): 425-429.
  • 安全信息
    . 2006, 8(5): 394-395.
  • Zhang Ruiqin, Kang Jianbang, Li Xiaoxia, Yin Donghong, Gao Yating, Zhang Zhiqi, Duan Jinju, Hou Ruigang
    . 2017, 19(2): 103-108.
    ObjectiveTo observe and compare the resistance changes of ciprofloxacin (CIP), levofloxacin (LEV), norfloxacin (NOR) to Pseudomonas aeruginosa (PA), and choose the drug which had the best curative effect for PA from the drugs mentioned above.MethodsSeven strain of non-repetitive PA which had sensitiveness to ciprofloxacin (CIP), levofloxacin (LEV), norfloxacin (NOR) and the same minimal inhibitory concentration (MIC) of the three drugs were co-cultured with CIP, LEV, NOR in concentrations of 0.5, 1.0, 2.0, and 4.0 times of MIC for evoked drug resistance, respectively. The MIC of CIP, LEV, and NOR to PA which evoked drug resistance by 3 kinds of concentration were detected by the methods of Epsilometer Test and Two-fold Agar Dilution.ResultsThe MIC value of CIP to PA after evoking by 3 concentrations increased from 0.09 μg/ml before evoking to 0.25-16.00 μg/ml. The MIC after evoking was 3 to 178 times that before evoking. The MIC value of NOR to PA after evoking increased from 0.50 μg/ml before evoking to 2.00-64.00 μg/ml. The MIC after evoking was 4 to 128 times that before evoking. The MIC value of LEV to PA after evoking by 3 concentrations increased from 0.50 μg/ml before evoking to 2.00-32.00 μg/ml. The MIC after evoking was 2 to 64 times that before evoking.The differences of MIC of CIP to PA after evoking by different concentrations of CIP, NOR and LEV were not statistically significant (all P>0.05). The MIC value of NOR to PA after evoking by 4.0×MIC CIP was higher than that of evoking by 0.5×MIC CIP (P=0.006). The MIC value of NOR to PA after evoking by 4.0×MIC LEV was higher than that evoked by 1.0×MIC LEP (P=0.006).The MIC value of LEV to PA after evoking by 4.0×MIC CIP was higher than that of evoking by 0.5×MIC CIP (P=0.006). The MIC value of LEV to PA after evoking by 4.0×MIC NOR and LEV were higher than those evoked by 0.5×MIC NOR and LEV (all P=0.007).ConclusionPA can be evoked to develop resistance to different degrees after co-culturing with different concentrations of CIP, LEV, and NOR. The change of resistance of CIP to PA is the least among the three drugs mentioned above. It is suggested that CIP is still one of the best fluoroquinolones for the treatment of PA infection.
  • Li Ya, Wang Xin
    . 2017, 19(4): 302.
    A 36-year-old male patient with condyloma acuminatum received intramuscular injection of recombinant human interferon-α1b (RH-IFN-α1b) 50 μg once every two days. Six hours after the first injection, the patient  developed high fiver and muscle pain. The symptoms disappeared about 8 hours later after going to bed and drinking hot water. He had no discomfort after the second to the fourth injection. About 5 minutes after the fifth injection, the patient developed amaurosis, irritability, chest tightness, palpitations, dyspnea, decreased blood pressure, increased pulse rate and respiratory rate, erythema and wheal in his trunk and face, and etc. He was diagnosed with anaphylactic shock and severe acute urticaria. He received the treatments of in horizontal position, oxygen inhalation, and anti-allergic medicine. Forty minutes later, the above-mentioned symptoms disappeared. Weakness, amaurosis, chest tightness, palpitations, and dyspnea recurred immediately at the 6th injection of RH-IFN-1b, and fecal incontinence and erythematous wheal appeared on the trunk  30 minutes later. RH-IFN-1b was stopped and the anti-allergic therapy was given. Three days later, the above-mentioned symptoms totally disappeared.
  • Zeng Weiqiang, Zhang Xiaojuan, Lin Chunjing, Ma Dong, Yang Dongyang, Lao Haiyan
    . 2016, 18(5): 375.
    A 62-year-old female with colon cancer and peritoneal metastasis was treated with an IV infusion of bevacizumab 5 mg/kg (the first days) combined with FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil) chemotherapy, 14 days as a cycle. At the end of the 7 cycles, the patient developed waist discomfort, body temperature was 38.6 ℃. CT showed bilateral renal infarction, it was considered to be caused by bevacizumab. Bevacizumab was withdrawn and FOLFOX regimen continued. After 3 cycles of chemotherapy, the regimen changed to capecitabine monotherapy. Four months later, CT showed bilateral renal infarct size reduced.
  • Wang Nana, Zhou Guiqin
    . 2016, 18(4): 290.
    Tamoxifen is widely used in the treatment of patients with estrogen receptor positive breast cancer. Tamoxifen can lead to fatty liver. Risk factors of tamoxifen induced fatty liver were obesity, hyperlipidemia, and hyperglycemia. The mechanism of tamoxifen induced fatty liver includes drugs estrogen antagonism, influence on fatty acid metabolism enzyme expression and activity, promoting fatty acid synthesis, and influencing lipid metabolism related nuclear receptors. The above factors interfering with fatty acid metabolism cause fat accumulation in the liver. Obeticholic acid can improve the prognosis of patients with fatty liver induced by tamoxifen.
  • 专家论坛
    . 2011, 13(5): 273-5.
  • Yin Yuesong, Shi Yanshuo, Wu Yupei, He Lien, Xu Xiaofei, Fan Xiaoyan
    Adverse Drug Reactions Journal. 2024, 26(11): 702-704. https://doi.org/10.3760/cma.j.cn114015-20240511-00335
    A 67-year-old male patient with intrahepatic bile duct carcinoma was treated with oxaliplatin (hepatic artery perfusion)+gemcitabine (hepatic artery perfusion)+camrelizumab (intravenous infusion)+apatinib (oral). Platelet count (PLT) decline (49×109/L) was observed after 2 months (apatinib had been discontinued by himself), which was improved after platelet elevating therapy. Due to multiple tumor metastases, bevacizumab (hepatic arterial perfusion, once per 30 days) was added. Before bevacizumab treatment, PLT and coagulation function of the patient were basically no abnormalities. After 2 cycles of treatments, the PLT was 101×109/L and prothrombin time was 14.1 s. Considering the high risk of bleeding in interventional therapy, oxaliplatin and gemcitabine were discontinued, and bevacizumab administration was changed to intravenous infusion. PLT and coagulation function were not improved. Six days after the 5th dose of bevacizumab, the patient had intermittent hematemesis twice (about 300 ml). Laboratory tests showed PLT 75×109/L and prothrombin time 15.8 s. The patient was diagnosed with digestive tract hemorrhage. Fasting and water restriction was performed, and gastric acid suppression, hemostasis, parenteral nutrition, etc. were given. The patient had no hematemesis but intermittent black stool. Gastroscopy indicated duodenal ulcer accompanied by bleeding. Rabeprazole and sucralfate were added. Fasting was stopped and liquid diet was given. The next day, the patient had blood in the stool, and the bleeding of the lower digestive tract was judged to be related to camrelizumab and bevacizumab. The bleeding symptoms were slightly improved after treatments with arterial embolization hemostasis and type A cryopprecipitation coagulation factor, etc. Later, the patient had repeated bleeding condition, and finally died despite of rescue efforts.
  • Li Ke'nan, Shi Huihui, Wang Xueying, Yuwen Lixia, Wang Lihua, Feng Ya′nan, Chen Wenjuan
    Adverse Drug Reactions Journal. 2024, 26(12): 732-736. https://doi.org/10.3760/cma.j.cn114015-20240326-00196
    Objective To explore the role of using laboratory critical values for active monitoring of serious adverse drug reactions (SADRs) in pharmacovigilance. Methods Xingtai Central Hospital was used as a sentinel hospital. The reports containing critical value in blood routine, blood biochemistry, blood gas analysis, and coagulation function from July 2022 to December 2022 were collected by the laboratory information system in the hospital. The electronic medical records of patients involved in the reports were reviewed, and the correlation between therapeutic drugs and the critical values was evaluated. The critical values related to adverse drug reactions (ADRs) and SADRs, and the suspicious drugs were analyzed by descriptive statistics. The occurrence of ADRs and SADRs in outpatients/emergency patients and hospita- lized patients were compared. Results A total of 1 597 reports containing critical values were included in the analysis. In these reports, 174 (10.90%) were judged to be related to ADRs, of which 68 (39.1%) were related to SADRs. The proportion of reports containing critical values in the Inpatient Department was signi- ficantly higher than that in the Outpatient/Emergency Department [0.39% (1 114/288 541) vs. 0.16% (483/307 176), P<0.001]; the proportion of reports related to ADR in all laboratory reports of the Outpatient/Emergency Department was significantly higher than that of the Inpatient Department [14.29% (69/483) vs. 9.43% (105/1 114), P=0.004]; the proportion of reports involving SADRs in those involving ADRs [31.88% (22/69) vs. 43.81% (46/105)] and that in all reports [4.55% (22/483) vs. 4.13% (46/1 114)] both were similar between Outpatient/Emergency Department and Inpatient Department, and the differences were not statistically significant (all P>0.05). Six-eight reports of SADR involved 80 critical values, and the top 3 were leukopenia (mainly involving anticancer drugs), coagulation dysfunction (mainly involving anticoagulants) and electrolyte disorder (mainly involving antihypertensive drugs), some of which were induced by medication errors or improper drug use. Conclusions Reporting laboratory critical values can effectively do some help in implement of active monitoring of SADRs in blood cells, blood biochemistry and coagulation function caused by drugs, which is conducive to the timely detection of SADRs in outpatient/emergency and hospita- lized patients, as well as serious adverse events caused by medication errors and inappropriate treatments.
  • Ji Liwei
    Adverse Drug Reactions Journal. 2025, 27(3): 142-146. https://doi.org/10.3760/cma.j.cn114015-20240528-00368
    Sodium-glucose transporter 2 inhibitors (SGLT2i) are currently widely used as a class of hypoglycemic drugs. Due to their unique hypoglycemic mechanism and significant cardio-renal protective effect, SGLT2i have become one of the core drugs in the treatment of type 2 diabetes mellitus. However, in recent years, it has been found that SGLT2i can lead to increased serum creatinine and urea nitrogen in some patients, and the risk of kidney injury has gradually attracted clinical attention. How to effectively prevent and supervise the potential renal injury risk while giving full play to its therapeutic advantages has become an important topic in current clinical practice and drug safety management. Multi-dimensional prevention and supervision strategies should be adopted in clinical practice such as identifying high-risk populations based on the latest evidence, strictly screening patients, dynamically monitoring renal function, optimizing combination medication regimens, and achieving risk warning using biomarkers and artificial intelligence tools.
  • Yang Haipeng, Chen Shuang, Zhao Weiwei, Zhao Liling, Xie Ruohan, Li Junxia
    Adverse Drug Reactions Journal. 2023, 25(4): 248-250. https://doi.org/10.3760/cma.j.cn114015-20220503-00378
    A 43-year-old male patient with type 2 diabetes mellitus underwent off-pump coronary artery bypass grafting due to coronary atherosclerotic heart disease. Dapagliflozin was stopped 24-hours before the operation, fasting and discontinuing oral medication started at 8:00-pm 1 day before the operation. On the day of surgery, blood gas analysis and blood glucose were normal before undergoing cardiopulmonary bypass. Tracheal intubation was successfully removed 7 hours after operation. Blood glucose and anion gap were 11.2-mmol/L and 13-mmol/L, respectively on the 2nd day after operation. The treatments of hypogly- cemic, antihypertensive and lipid-regulating drugs and normal diet were restored. On the morning of the 3rd day after operation, the patient developed symptoms such as shallow rapid breathing, poor appetite, excessive urine, and irritability. Blood gas analysis showed pH 7.05, arterial partial pressure of carbon dioxide (PaCO2) 11-mmHg, base excess -24.5-mmol/L, actual bicarbonate 21.7-mmol/L; blood glucose 10.4-mmol/L, potassium 5.3-mmol/L, and routine urine test showed ketone body (+++) in urine. Treatments such as fluid replacement, electrolyte correction, and acid-base balance, and insulin therapy were given. Ten hours later, the blood gas analysis showed pH 7.44, PaCO2-32-mmHg, alkali residual -2.5-mmol/L, actual bicarbonate 21.7-mmol/L, anion gap 12-mmol/L, blood glucose was 6.7-mmol/L, and routine urine test showed ketone body (++) in urine. The patient′s symptoms were gradually improved on the 4th day after the operation and then metformin, acarbose, and insulin injection were given for blood glucose management. It was considered that the patient had ketoacidosis, which might be associated with dapagliflozin. Then the hypoglycemic regimen was adjusted to oral metformin 0.85 g twice daily, acarbose 50-mg twice daily, and glimepiride 2-mg twice daily on the 15th day after operation. After that, the fasting blood glucose in the patient was maintained at 8.2-10.6-mmol/L, the postprandial blood glucose was maintained at 8.2-13.1-mmol/L, and the glycosylated hemoglobin was 7.3%. The patient′s ketoacidosis did not recur.
  • . 2017, 19(2): 155-155.
  • . 2015, 17(2): 99-100.
  • Wang Zhengyu, Luo Bohan, Lyu Yong, Niu Jing, Yuan Jie, Han Na, Li Xiaomei, Zhu Ying,Chen Hui, He Chuangye, Yin Zhanxin, Song Hange, Han Guohong
    ObjectiveTo understand the incidence and risk factors of warfarin related hemorrhagic events during anticoagulation therapy with warfarin in patients with cirrhosis and portal vein thrombosis(PVT) after transjugular intrahepatic portosystemic shunt (TIPS).MethodsThe patients with liver cirrhosis who were treated with warfarin after TIPS due to portal hypertension were followed up from January 2012 in Xijing Hospital of Digestive Diseases, Air Force Military Medical University. The data of medical records and follow-up records up to the end of December 2015 in patients undergoing TIPS were collected and retrospectively analyzed. Cumulative incidence of hemorrhagic events related to warfarin treatment was calculated by Kaplan-Meier method. The patients were divided into warfarin-related bleeding group (bleeding group) and non warfarin-related bleeding group (non-bleeding group). The risk factors of hemorrhagic events related to warfarin treatment were analyzed using Cox regression model and the hazard ratio (HR) and the 95% confidence interval (CI) were calculated.ResultsA total of 179 patients were enrolled, including 117 males and 62 females with ages of 25-79 years and average age of (52±12) years; the bleeding group comprised 47 patients (26.3%) and the non-bleeding group comprised 132 patients (73.7%). The follow-up time after discharge ranged 1-74 months and the average time was (28±21) months. The average portal pressure gradient dropped from (25.4±5.2) to (8.7±3.7) mmHg before and after TIPS (P<0.001). The median dose of oral warfarin in patients in the bleeding group was 2.5 (ranged from 2.5 to 3.75) mg and the median INR was 3.12 (ranged from 2.04 to 9.41); the median dose of oral warfarin in patients in the non-bleeding group was 1.8 (ranged from 0.63 to 2.5) mg and the median INR was 1.85 (ranged from 1.5 to 3.38). Fifty eight cases of hemorrhagic events occurred in 47 patients in the bleeding group, including 24 cases of gingival bleeding, 16 cases of epistaxis, 8 cases of cutaneous purpura, 4 cases of conjunctival hemorrhage, 2 cases of hemorrhage of digestive tract, 2 cases of intracranial hemorrhage, 1 cases of hematuria, and 1 cases of menorrhagia. Nine of the 47 patients in the bleeding group had bleeding from multiple sites. The results of Kaplan-Meier analysis showed that the 1-, 2-, 3-, 4-, 5- and 6-year cumulative incidences of hemorrhagic events related to warfarin treatment after operation were 19%, 23%, 24%, 30%, 41%, and 45%, respectively. Warfarin was stopped in 11 patients and given at reduced doses in 36 patients among the 47 patients in the bleeding group. After that, 43 patients′ hemorrhagic symptoms disappeared and 3 patients′ symptoms relieved, and then warfarin treatments were continued, except that 1 patient with a long history of hypertension died of intracranial hemorrhage. Multiple Cox regression analysis showed that the baseline serum creatinine level >115 μmol/L was an independent risk factor for hemorrhagic events related to warfarin treatment (HR=1.82, 95%CI: 1.01-3.28, P=0.045).ConclusionsIt is relatively safe for patients with liver cirrhosis and PVT receiving warfarin anticoagulation therapy after TIPS. Elevated serum creatinine is an independent risk factor for hemorrhagic events related to warfarin treatment.
  • Sun Yang, Pang Dongqing, Liu Linlin, Liu Fang
    . 2017, 19(6): 469.
    A 79-year-old female patient with chronic asthmatoid pulmonary disease received compound phenytoin sodium, ephedrin hydrochloride and theophylline tablets 2 tablets twice daily by mouth. The patient developed discontinuous cephalic and facial involuntary movements after 2 months of medication and discontinuous dizziness with weakness of the lower limbs and gait instability after 9 months of medication.After 1 year of medication, the patient changed 2 to 5 tablets twice daily by herself due to the poor curative effect. Two years after high-dose of treatment, the patient developed aggravated involuntary movements and dizziness, body backward and was unable to stand and walk. Ataxia and myodystony due to long-term and high-dose use of compound phenytoin sodium, ephedrin hydrochloride and theophylline tablets was considered. The drug was stopped, an IV infusion of 0.9% sodium chloride injection 500 ml once daily and an intramuscular injection of adenosine cobalamin 1.5 mg once daily were given. Three days later, the patient′s cephalic and facial involuntary movements disappeared and dizziness markedly alleviated. Five days later, the patient could walk with other person′s help. Eight days later, the patient could walk alone.
  • Cai Haodong
    Adverse Drug Reactions Journal. 2019, 21(4): 241-243. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.001
    Anticoagulant therapy is an effective method to prevent or treat vascular thromboembolism, but there are also many safety problems. The most common adverse reaction of anticoagulants is bleeding. Intracranial hemorrhage and gastrointestinal hemorrhage, which sometimes even threaten their lives, may occur in severe cases. Attention should be paid to thrombocytopenia induced by heparin anticoagulants and adverse reactions such as liver injury, rash and skin injury, and kidney injury associated with new oral anticoagulants. The safety problems of anticoagulants are related not only to the drugs themselves, but also to the different indications, opportunities, and drug variety due to their application in various clinical departments; the anticoagulants are mostly applied to elderly outpatients, which makes their supervision more difficult. Medical staffs in various clinical departments should pay attention to the safety management of anticoagulants, strictly follow the relevant guidelines, try to accumulate more experience in clinical application, and ensure the medication safety of patients.
  • Wang Xiao, Sun Zhenxiao, Xu Chunmei
    Adverse Drug Reactions Journal. 2021, 23(2): 98-99. https://doi.org/10.3760/cma.j.cn114015-20200605-00640
    A 29-year-old male patient was treated with quetiapine fumarate (maintenance dose: 0.2 g twice daily) and magnesium valproate sustained release tablets (maintenance dose: 0.5 g twice daily) for bipolar affective disorder. After 9 days of treatments, the patient′s psychiatric symptoms were improved, no adverse reactions occurred, and plasma concentration of quetiapine was 379-μg/L. Clarithromycin 0.25 g orally twice daily was added because of concurrent suppurative otitis media. The next morning, the patient developed lethargy and the blood concentration of quetiapine increased to 614-μg/L, which was considered to be caused by the interaction of clarithromycin and quetiapine. Quetiapine fumarate and clarithromycin were discontinued and intravenous fluids were given to accelerate drug metabolism rate. On the 2nd day, the patient′s lethargy disappeared. Quetiapine fumarate at the original dose was given, magnesium valproate sustained-release tablets were continued, and the antimicrobial drug was switched to cefdinir capsules 0.1 g orally thrice daily. Then the symptoms above-mentioned did not recur.
  • Gu Huan, Jiang Huadong
    Adverse Drug Reactions Journal. 2021, 23(1): 52-53. https://doi.org/10.3760/cma.j.cn114015-20200609-00655
    A 49-year-old male patient with stage IV lung adenocarcinoma received IV infusions of pemetrexed disodium 0.8 g dissolved in 0.9% sodium chloride injection 100-ml on the 1st day and cisplatin 30-mg dissolved in 0.9% sodium chloride injection 250-ml in the first 4 days (each treatment cycle was 21 days). At the same time, he received targeted therapy with gefitinib 250-mg orally once daily. On the 10th day of drug withdrawal in the third chemotherapy cycle, the 59th day of gefitinib administration, the patient developed dizziness and decreased vision. The ophthalmic examination showed retinal hemorrhage and elevated intraocular pressure, which were considered to be related to gefitinib. Because of the patient′s condition, the original treatments were continued, and the treatments of reducing intraocular pressure and restoring vision were given at the same time. On the 4th day of the continuation of original treatments, his dizziness was slightly improved, but the visual was not. On the 10th day, his vision did not recover. After that, the patient was lost to follow-up.
  • 病例报告
    . 2004, 6(2): 115-116.
  • 病例报告
    Fan Ruying;Zhao Xiaojun
    . 2008, 10(1): 0-0.

    A 72yearold woman with rheumatoid arthritis took methotrexate 2.5 mg twice daily. One week later, she developed abdominal pain and diarrhea. Methotrexate was discontinued, and the patient was given treatment with norfloxacin and berberine, however, her symptoms did not resolve. A blood routine test after hospitalization showed the following levels: WBC 1.6×109/L, RBC 2.7×1012/L, Hb 86 g/L, and PLT 51×109/L. Despite administration of granulocyte colonystimulating factor and levofloxacin, her peripheric blood cell counts decreased progressively. Watery stools turned to mucus bloody stools. Petechia and ecchymosis appeared on her skin. She received calcium folinate 15 mg thrice daily by intramuscular injection. On the fourth hospital day, her WBC count was 0.5×109/L, her Hb level was 73 g/L, and her PLT count was 11×109/L. Platelet and packed red cells were given by intravenous infusion, and treatment with fluid infusion, hematischesis, and antiinfection continued. One week later, the patient's abdominal pain and diarrhea relieved. A reexamination of blood routine showed a WBC count of 4.9×109/L, a Hb level of 76g/L, and a PLT count of 70×109/L. At follow-up 2 years later, her blood routine test showed normal findings.

  • 系列问答
    . 2009, 11(4): 300-1.
  • Adverse Drug Reactions Journal. 2002, 4(5): 351-351.
  • Adverse Drug Reactions Journal. 2020, 22(2): 57-57. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.001
  • Duan Man, Huang Qiuming
    Adverse Drug Reactions Journal. 2019, 21(2): 102-107. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.006
    ObjectiveTo explore the clinical characteristics of cardiotoxic reactions induced by nivolumab.MethodsCNKI, VIP, Wanfang, PubMed, Web of Science and MEDLINE databases were searched up to September 2018. The literature containing cases on cardiotoxic reactions induced by nivolumab was collected, relevant information was extracted, and the clinical characteristics of cardiotoxic reactions induced by nivolumab were analyzed.ResultsA total of 22 patients enrolled in the study, including 13 males and 9 females, aged 35-80 years, of them, 70.3% (17 cases) patients were>60 years old. Primary diseases of the patients included malignant melanoma (9 patients), lung adenocarcinoma (6 patients), squamous cell carcinoma of lung (2 patients), type B3 thymoma (1 patient), non-small-cell lung cancer (1 patient), Merkel cell carcinoma (1 patient), uveal melanoma (1 patient), and clear cell renal cell carcinoma (1 patient). There were 6, 1, 1, and 4 patients with history of hypertension, cardiac pacemaker implantation, pseudo bundle branch block syndrome, and targeted therapy with tyrosine kinase inhibitor, respectively. Of the 22 patients, 15 patients received nivolumab monotherapy, 6 patients received combination therapy with nivolumab and ipilimumab, and one patient received 3 months′ ipilimumab before nivolumab. There were 2 patients received nivolumab without reasonable dosage and frequency according to the specifications, and 10 patients with missing information of drug dosage and frequency. Cardiotoxic reactions appeared 47 times totally in the 22 patients, mainly including myocarditis (13 times), heart block (6 times), pericardial effusion (5 times), and etc., and mainly performing as the clinical characteristics of pectoralgia, dyspnea, anhelation, and fatigue. Cardiotoxic reactions first appeared on the 4th day and lastly on the 327th day after the initial dose. After the appearance of cardiotoxic reactions, nivolumab were stopped immediately in 20 patients and after the reactions improved in 1 patient, while intermittent medication was conducted in another 1 patient. Of the 22 patients, 17 received symptomatic treatments, 4 received pacemaker implantation, 18 received high-dose glucocorticoid shock therapy, and 6 received immuno-therapy. Of the 22 patients, 9 (40.9%) died, 12 had improved symptoms, and 1 had unknown prognosis.ConclusionsThe cardiotoxic reactions induced by nivolumab were characterized by dispersed incubation period and higher mortality. The symptomatic treatments and high-dose glucocorticoid treatment have a certain positive effects.
  • Fan Baoxia, Zhang Wen
    . 2018, 20(1): 69.
    The patient was an eighty-six years old women suffered from incomplete intestinal obstruction and gastrointestinal bleeding. She was treated with abrosia, hemostatic and antacid agents. At the same time, 20% fat emulsion (C14-24) (250 ml, once daily), 50% glucose (60 ml, once daily), and 5% compound amino acid injection (18 AA-Ⅱ) (250 ml, once daily) were given. On the second day of treatment, the patient showed symptoms of fever, tachycardia, recurrent atrial fibrillation and nausea. After seven days treatment, her laboratory results showed serum triglyceride 10.8 mmol/L, total cholesterol 15.5 mmol/L, aspartate aminotransferase (AST) 248 U/L, alanine aminotransferase (ALT) 100 U/L. After stopping fat emulsion for seven days, her laboratory results were serum triglyceride 8.1 mmol/L, total cholesterol 10.1 mmol/L, AST 62 U/L, ALT 17 U/L, and heart symptoms improved. Fat overload syndrome caused by infusion of fat emulsion was diagnosed. Although the symptoms were improved after the  discontinuation of fat emulsion, the patient died of concurrent infection and multiple organ failure.
  • . 2015, 17(2): 95-97.
  • Ma Yunhua, Chen Min
    . 2015, 17(5): 367.
    Antineutrophil cytoplasmic antibody (ANCA) associated small vessel vasculitis (AAV) induced by propylthiouracil (PTU) accounted for 80%-90% of vasculitis due to anti hyperthyroidism drugs. AAV is the disease which involved the systems of respiration, kidney, skin, muscle, nerve, stomach and intestine and ophthalmology and otorhinolaryngology. The clinical manifestations of AAV include fever, weakness, weight loss, myalgia and arthralgia, purpuric skin injury, hematuresis, conjunctivitis, pulmonary alveolar hemorrhage, and acute renal failure, can be even life-threatening. Laboratory examination showed positive ANCA. The mechanism of AAV induced by PTU may be related to interaction of PTU and myeloperoxidase (MPO). Long-term use of PTU may be the high risk factor in AAV. Serum anti-MPO antibody positive, anti-MPO antibody titer and the affinity to MPO antibody may be also related to PTU-AAV. The diagnostic code of PTU-AAV include (1) appearance of clinical symptoms of small vessel vasculitis and have the specific relationship between symptoms and medication time; (2) ANCA test show positive or titer elevating; (3) tissue biopsy shows inflammatory reaction and necrosis in small vessels, and renal needle biopsy shows focal segmental necrosis of cellulose and /or crescentic glomerulonephritis; (4) other diseases which may induce vasculitis, such as infection and tumor can be excluded. The main treatments for AAV are withdrawal of PTU timely and rational combination of steroids and cytotoxic drugs. The prognosis of PTU-AAV is closely related to the damage range in small vessels. The overall prognosis of PTU-AAV is better than that of primary small vessel vasculitis.
  • ADR咨询
    . 2004, 6(2): 139-139.
  • Zeng Ajuan, Han Ying, Ding Huiguo
    Adverse Drug Reactions Journal. 2023, 25(1): 2-5. https://doi.org/10.3760/cma.j.cn114015-20230109-20230001
    At present, 3 drugs specially for coronavirus disease 2019-have conditional marketing authorization (CMA) in China, including molnupiravir, nirmatrelvir/ritonavir, and azvudine. The data of clinical efficacy and safety of these drugs are relatively insufficient. Molnupiravir is not the main inhibitor or inducer of drug metabolizing enzyme or transporter and is less likely to have drug interactions, which may be more beneficial to patients with chronic diseases needing long-term drug treatments. Ritonavir in Paxlovid is a strong inhibitor to the key drug metabolism enzyme---CYP3A4, and may interact with a variety of drugs such as drugs for arrhythmia, diabetes, nervous system diseases, etc., resulting in increased drug safety risks in the treatment of underlying diseases. The reproductive and genetic toxicity recorded in the drug label of azvudine is worrying. Joint efforts of our government, hospital managers, clinicians and pharmacists are necessary to achieve the safety management of the 3 drugs, including improving the relevant CMA management regulations, strengthening the efficacy and safety monitoring of these drugs, conducting real world clinical research, and monitoring the variation and drug resistance of the virus.
  • Pan Bobo, Huang Jie, Huang Yuena, Zhong Han, Dai Youqin
    Adverse Drug Reactions Journal. 2022, 24(1): 51-53. https://doi.org/10.3760/cma.j.cn114015-20210106-00023
    An 83-year-old female patient received gefitinib 0.25 g once daily due to right lung adenocarcinoma with left lung metastasis and suspicious liver metastasis. She developed severe diarrhea with nausea and vomiting 27 days after treatment. Laboratory test showed that blood potassium was 2.1-mmol/L. The results of fecal culture were negative, and infectious diarrhea was excluded. Gefinib was continued. After 4 days of treatments with potassium supplement and antidiarrheal, the patient recovered. Four days later, the patient developed the above symptoms again, and the laboratory test showed that the blood potassium was 2.96-mmol/L. Diarrhea and hypokalemia were considered to be related to gefitinib. The drug was withdrawn and the symptomatic treatments such as potassium supplement, antidiarrheal, antiemetic, and stomach protection were given. Nine days of drug withdrawal, her symptoms of diarrhea, nausea, and vomiting were relieved, and laboratory test showed that blood potassium was 3.52-mmol/L; 22 days of drug withdrawal, the diarrhea, nausea, and vomiting disappeared, and the laboratory test showed that blood potassium was 4.69-mmol/L.
  • 读者·编者·消息
    . 2003, 5(4): 282-283.
  • 病例报告
    . 1999, 1(3): 186-187.
  • 安全信息
    . 2013, 15(3): 156-1.
  • . 2017, 19(2): 154-154.
  • Hu Rongrong, Zhuang Junling
    . 2017, 19(6): 459.
    A 41-year-old male patient with acute myelogenous leukemia and past history of Behcet′s disease received allogenic hematopoietic stem cell transplantation. Tacrolimus 2.5-3.0 mg/24 h was administered through continuous intravenous pump and the serum level was 10.0-15.0 ng/ml. On day 30, the patient experienced severe delirium manifesting as anxiety, color vision defects, irrelevant answer, and losing the ability to calculate and hypoorientation. On day 33, serum tacrolimus level was maintained at  6.0-7.5 ng/ml, but the patient′s mental symptoms was not improved. The next day, tacrolimus was stopped, the delirium was relieved. On day 35, he switched to oral tacrolimus (the initial dose 1 mg twice daily, on day 7, the dose was adjusted to 2 mg twice daily). On day 10 of oral tacrolimus, he developed consciousness disorder again with refusing to eat. Therefore oral tacrolimus was stopped, an IV infusion of cyclosporine 125 mg twice daily was given. On day 2, the symptom of delirium appeared again, accompanied by self harming behavior. On day 5, cyclosporine was withdrawn and he returned to normal consciousness. After that, rapamycin 1 mg twice daily was orally administered. The delirium did not recur.
  • Chen Weibi, Wen Yumei, Su Yingying, Zhang Yan
    . 2016, 18(6): 455.
    A 61-year-old patient with carotid artery stenting received long-term oral clopidogrel 75 mg once daily. He was given subcutaneous injection of dalteparin sodium 5 000 U once daily due to acute cerebral infarction. On day 10, his platelet count was 89×109/L, clopidogrel was stopped. Two days later, the platelet count was 25×109/L, he developed right lower limb swelling, superficial vein expansion and feet cyanosis. Vascular ultrasound showed extensive deep venous thrombosis in the right lower extremity and bilateral anterior tibial artery occlusion. Anti-heparin/platelet factor 4 antibody was found positive. Heparin-induced thrombocytopenia with thrombosis was considered. Dalteparin sodium was withdrawn, which was replaced with argatroban 10 mg with microdose venous pump every four hours. On day 2, the swelling of the right lower limb relieved and blood platelet count was 36×109/L. On day 11, blood platelet count was 123×109/L. Argatroban was replaced by nasal feeding rivaroxaban 15 mg twice daily. Three months later, the blood platelet count returned to 196×109/L and vascular ultrasound revealed that the deep vein thrombosis in the right lower limb was partly restored.
  • Xu Xiuli, Yang Yuhui, Zhu Zhu
    Adverse Drug Reactions Journal. 2019, 21(2): 84-84. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.001
    The marketing of new drugs has brought more treatment methods for some diseases. However, due to the small number and narrow selection range of subjects and short research time in the pre-market clinical trials of new drugs, it is difficult to find adverse reactions with low incidence, or occurred after long-term use or in special populations. Therefore, there are still unknown risks for new drugs in their post-maket applications in a wide range of people. In addition, risks of adverse drug events may increase due to being unfamiliar with the clinical application of new drugs by most medical staff and the poor medication adherence in patients in the early stage of new drug marketing. Therefore, drug regulatory authorities, medical institutions, drug license holders, and etc. should attach great importance to postmarketing safety monitoring of new drugs. Drug regulatory authorities in China have issued a series of measures to strengthen the postmarketing monitoring of new drugs. Medical staff should learn and master the professional knowledge of rational use of new drugs as soon as possible, actively carry out monitoring and clinical research on adverse events of new drugs, and strengthen guidance on patient′s medication. The drug license holders should fulfill the responsibility for drug quality and safety, and take major responsibility for reporting adverse reactions and events.
  • 病例报告
    Xu Weifeng
    . 2008, 10(1): 0-0.

    A 36yearold woman with facial rash received antianaphylactic treatment with tranilast capsules 0.1 g thrice daily for 20 days. During this period, she also took loratadine, cetirizine, etc. She continued to use tranilast for 8 days after her skin rash faded. However, within the last 4 days of tranilast administration, the patient developed urinary frequency, urgency, odynuria, gross hematuria, and mild lethargy. After admission, laboratory tests revealed the following levels: ALT 716 U/L, AST 263 U/L, TBIL 41.1 μmol/L, DBIL 20.0 μmol/L, IBIL 21.1 μmol/L, GGT 246 U/L, ALP 372.3 U/L. A blood routine test showed eosinophile granulocyte count of 0.66×109/L. An urinalysis revealed RBCs filled per highpower field. On the second hospital day, the patient developed a fever (T 38.5 ℃), anorexia, nausea, jaundice, mild pruritus, discomfortableness on percussion at her right renal region. She was treated with liverprotective, antiinfective, and intravenous fluid therapy. Ten days later, the patient's condition started to improve. After 24 days of treatment, all laboratory values were within normal limits.

  • SARS防治
    . 2003, 5(3): 149-149.
  • 病例报告
    . 2001, 3(4): 253-254.
  • ADE简报
    . 2001, 3(2): 124-125.
  • 抗菌药应用
    . 2005, 7(6): 437-444.
  • 病例报道
    . 1999, 1(1): 50-51.
  • Hou Kaixuan, Xing Xiaoxuan, Yan Suying
    ObjectiveTo evaluate and compare the condition of potentially inappropriate medications (PIM) in elderly inpatients in our hospital by the new edition of Beers and the STOPP criteria.MethodsThe patients who were ≥65 years old and discharged from the internal medicine ward of Xuanwu Hospital, Capital Medical University in March 2017 were enrolled into the study. The patients′  basic information (gender, age), coexistence diseases, Chalson Comorbidity Index (CCI) scores, types of drug used during hospitalization, expenses for medicine, and total hospitalization expenses were collected. The Beers criteria (2015) and the STOPP criteria (2014) were used respectively to evaluate the PIM in inpatients and logistic regression analysis was used to analyze related factors of PIM occurrence.ResultsA total of 453 patients were enrolled into the study, including 247 males and 206 females, aged 65-97 years with the mean age of (74±7) years. The hospitalization time was 2 to 57 days, the median hospitalization time was 10 (7, 13) days; the number of coexistence diseases was 1 to 42, the median number of coexistence diseases was 8 (5, 12); the number of drug types during hospitalization was 1 to 57, the median number of drug types was 12 (8, 17); CCI scores were 0 to 7 points, the median CCI score was 1 (1, 2). Two hundred and ninety patients (290/453, 64.0%) were prescribed at least 1 PIM by the Beers criteria, mainly including vasodilators (131/709, 18.48%), diuretics (123/709, 17.35%), and benzodiazepines (107/709, 15.09%). One hundred and eighty-nine patients (189/453, 41.7%) were prescribed at least 1 PIM by the STOPP criteria, mainly including benzodiazepines (101/283, 35.69%), first generation antihistamines (49/283, 17.31%), and repeated use of the same kind of drugs (30/283, 10.60%). The difference in PIM incidence assessed by the Beers and STOPP criteria among the patients with different gender was not statistically significant (P=0.161, P=0.438). The differences in PIM incidences assessed by the Beers and STOPP criteria at different ages, different hospitalization time, kinds of coexistence diseases, types of drug use, and CCI scores were all statistically significant (Beers criteria: P values were <0.001, <0.001, <0.001, <0.001, and 0.003, respectively; STOPP criteria: P values were <0.001, <0.001, <0.001, <0.001, and 0.010, respectively). The mortality and total hospitalization expenses in patients with PIM use identified by the Beers and STOPP criteria were higher than those in patients without PIM use (Beers criteria: P values were 0.001 and <0.001, respectively; STOPP criteria: P values were 0.001 and 0.006, respectively). The result of Kappa consistency test reviewed that the 2 criteria had general consistency. Aged 75-84 years, hospitalization time≥15 days, 6-10 and≥16 kinds of coexistence diseases, and ≥10 drugs types were risk factors of PIM occurrence in patients.ConclusionsMore PIM users could be determined by the Beers criteria. The PIM evaluated by STOPP criteria in elderly patients was more beneficial to clinical diagnosis and treatment. More PIM in elderly patients could be found by combining the results of the 2 criteria.
  • Song Zhihui, Zhao Huanyu, Wang Jiawei
    ObjectiveTo understand the occurrence of antibacterial-associated diarrhea (AAD) in adult inpatients, the main antibacterials leading to AAD, and the main clinical characteristics of AAD, so as to strengthen the prevention of this adverse reaction.MethodsThe medical records in adult patients who were treated with antibacterials during their hospitalization in Beijing Tongren Hospital, Capital Medical University from January 1, 2016 to May 31, 2017 were collected and retrospectively analyzed. The electric medical records data of patients with AAD were collected from hospital information system, related data were extracted, and antibacterials associated with diarrhea and clinical features and prognosis of AAD were descriptively analyzed. The main medical units where AAD occurred and major antibacterials leading to AAD were analyzed using Pareto analysis, and the rationality of antibacterials use in patients with AAD was evaluated.ResultsA total of 2 406 adult inpatients with antibacterial treatments were collected, of which 85 suffered from AAD (incidence 3.5%). Of the 85 patients, 48 were males and 37 females, the median age was 68 (31, 93) years, and 70 patients (82.3%) were ≥60 years old; 28 patients were from intensive care unit (ICU, 32.9%), 22 from health care unit for cadres (25.9%), 18 from general medical ward (21.6%), 13 from emergency comprehensive ward (15.3%), and 4 from surgical ward (4.7%). Pareto chart showed that the main medical units where AAD occurred were ICU ward, the health care unit for cadres, and the general medical ward. The application condition of antibacterials was as follows. Of the 85 patients, 62 (72.9%) were treated with a single antibacterial, including 23 cases receiving the third or fourth generation cephalosporins, 13 cephamycins, 11 broad-spectrum penicillins, 10 carbapenems, 3 quinolones, and 2 second generation cephalosporins; 23 (27.1%) were treated with 2 antibacterials, one of whose drugs was the third or fourth generation cephalosporins, broad-spectrum penicillins or cephamicins. Pareto chart showed that the main drugs causing AAD were the third or fourth generation cephalosporins, cephamicins, and broad-spectrum penicillins. Diarrhea occurred at 1-30 days after antibacterial treatments with an average period of (7.5±6.4) days. In the 85 patients, 26 patients (30.6%) were Clostridium difficile toxin positive in stools, of which 8 were diagnosed as pseudomembranous conjunctivitis, accounting for 9.4% of AAD and 30.8% of Clostridium difficile diarrhea. After 2-40 days′ treatment with intestinal micro-ecological drugs (80 cases), montmorillonite powder (60 cases), metronidazole (18 cases), vancomycin (10 cases), and etc., 48 patients (56.5%) were cured, 35 (41.2%) improved, and 2(2.3%) ineffective. The evaluation results of rationality of antimicrobials in clinical application showed that 4(4.7%) of the 85 patients with AAD received irrational use of antimicrobials, including 2 cases of unreasonable dosage and 2 cases of unreasonable combined use of drugs.ConclusionsThe incidence of AAD in adult inpatients in Beijing Tongren Hospital was 3.5%, and in patients with AAD, 30.6% suffered from Clostridium difficile diarrhea and 9.4% suffered from pseudomembranous conjunctivitis. The main drugs causing AAD were the third or fourth generation cephalosporin, cephamicins, and broad-spectrum penicillins.
  • Xue Honglin, Tan Yali, Liang Wen, Fei Yan
    A 68-year-old male patient with liver metastases from colon cancer received apatinib mesylate tablets 500 mg orally once daily after the hepatic arterial chemoembolization. On day 3 after the medication, the patient had a fever of 39 ℃ with fear of cold, and his proportion of neutrophils, C reactive protein, and procalcitonin levels slightly increased without any definite focus of infection. It was considered that the drug fever was related to apatinib mesylate tablets. Apatinib mesylate tablets were discontinued and anti-infection treatments were given. Ten days later, the patient′s body temperature returned to normal. Apatinib mesylate tablets were given again for the cancer but the patient had a fever again 3 days later. Apatinib mesylate tablets were stopped again, and then celecoxib capsules were given orally along with tepid sponge bathing to reduce fever. The patient′s body temperature returned to normal on day 3 after the drug withdrawal.
  • Li Jingyi, Wang Zhiyu
    . 2017, 19(4): 285.
    The risk of tumor necrosis factor inhibitor (TNFi) in treating patients with rheumatoid arthritis (RA) has been disputed and concerned. So far the research results showed that the TNFi treatment does not increase the risk of solid tumors such as breast cancer and lung cancer in RA patients. In terms of melanoma and other skin malignant solid tumors, existing conclusions are remain contradictory. It is not certain that if TNFi increases the risk of lymphoma and leukemia in RA patients. RA patients treated with TNFi should undergo long-term follow-up and observation, and should accept tumor screening if necessary.
  • 病例报告
    PANG Yong-feng
    . 2012, 14(4): 262-2.
    A 46-year-old male patient self-medicated with oral losartan potassium 50 mg once daily for hypertension. Seven months later, indapamide 2.5 mg once daily was added to his regimen due to poor control of his hypertension. A further five months later, his triglyceride level increased from 1.18 mmol/L to 5.07 mmol/L. The patient received a controlled diet and took adequate exercise. Two months later, his triglyceride level was 4.75 mmol/L. The increased triglyceride level was considered to be indapamide-associated. Indapamide was discontinued and, 15 days later, his triglyceride level decreased to 0.89 mmol/L.
  • Zeng Helin, Liao Zhimin
    Adverse Drug Reactions Journal. 2021, 23(9): 502-504. https://doi.org/10.3760/cma.j.cn114015-20201228-01291
    A 49-year-old female patient underwent laparoscopic exploration under general anesthesia due to bilateral tubal abscess complicated with acute renal failure. During anesthesia induction, midazolam, sufentanil, cisatracurium, and propofol were used successively, resulting in severe hypoxemia with the lowest pulse oxygen saturation of 0.57. Echocardiography showed right heart enlargement, tricuspid regurgitation, and pulmonary hypertension (estimated pulmonary artery pressure 62-mmHg). Through tracheal intubation, assisted breathing with mechanical ventilation, and treatments with hydrocortisone and papaverine, the hypoxemia was corrected and the operation was completed successfully. Echocardiography showed the pulmonary artery pressure returned to normal on the 2nd day after operation. The patient was determined to be hypersensitive to cisatracurium by a needle skin test on the 9th postoperative day. It was considered that the transient pulmonary hypertension in the patient was caused by pulmonary vasospasm due to allergic reaction to the drug.
  • Ma Yanli, Yuan Pingping, Zhang Wanhui, Ning Meiying, Zhao Jing
    Adverse Drug Reactions Journal. 2023, 25(12): 757-758. https://doi.org/10.3760/cma.j.cn114015-20230215-00089
    A 58-year-old male patient took Weikening tablets 1.24 g thrice daily orally for gastric ulcer by himself. The patient did not take other drugs during the same period. After 1 month of medication, the patient developed the symptoms such as abdominal distension, yellowish sclera, yellowish urine, and fatigue. Laboratory tests showed alanine aminotransferase (ALT) 1-272 U/L, aspartate aminotransferase (AST) 507 U/L, total bilirubin (TBil) 59-μmol/L, and direct bilirubin (DBil) 34-μmol/L. Acute liver injury caused by Weikening tablets was considered. Then the drug was stopped and treatments such as liver protective, choleretic, and enzyme reduction drugs were given. Ten days later, the above symptoms disappeared, and the liver function reexamination showed ALT 163-U/L, AST 43-U/L, TBil 23-μmol/L, and DBil 17-μmol/L. One month later, the patient′s liver function test showed ALT 31-U/L, AST 24-U/L, TBil 14-μmol/L, and DBil 6-μmol/L. It was considered that the liver injury of the patient may be related to greater celandine contained in Weikening tablets.
  • Wang Huimin
    Adverse Drug Reactions Journal. 2024, 26(9): 566-568. https://doi.org/10.3760/cma.j.cn114015-20231226-00934
    A 40-year-old female patient took Kangfuyan capsules 1.2 g (3 capsules) thrice daily orally by herself for cervical erosion. After 10 days of treatment, the patient developed anorexia and nausea; after taking the drug intermittently for about 30 days, the symptoms were not improved. Laboratory tests showed alanine aminotransferase (ALT) 793?U/L,aspartate aminotransferase (AST) 699 U/L, total bilirubin (TBil) 27.4 μmol/L, and alkaline phosphatase (ALP) 130 U/L. Drug-induced liver injury was diagnosed, which was considered to be related to Kangfuyan capsules. The drug was stopped, and the liver-protective treatments were given. Sixteen days later, the above symptoms in the patient were improved, laboratory tests showed ALT 79 U/L, AST 55 U/L, and ALP 79 U/L; 30 days later, laboratory tests showed ALT 44 U/L, AST 40 U/L, ALP 51 U/L, and TBil 21.5 μmol/L.
  • Fan Kongli, Fu Guangwei, Sang Xisheng
    Adverse Drug Reactions Journal. 2024, 26(4): 246-248. https://doi.org/10.3760/cma.j.cn114015-20230425-00307
    A 64-year-old female patient with bilateral knee joint pain received Hehe pills 10 g twice daily by herself. After 2 months of treatment, she stopped taking the medicine. On the 10th day after discontinuation of medication, yellowish skin, mucosa, and sclera appeared. Laboratory tests showed alanine aminotransferase 274-U/L, aspartate aminotransferase 274-U/L, alkaline phosphatase 713-U/L, total bilirubin 412.7-mmol/L, direct bilirubin 216.2-mmol/L. Severe liver injury caused by Hehe pills was considered. Symptomatic and supportive treatments including liver protection and jaundice reduction, and bilirubin adsorption were given. One month later, the yellowish skin, mucosa, and sclera in the patient were significantly improved, and 2 months later, liver function returned to normal. The patient′s liver injury was most likely related to the Aconiti Kusnezoffii Radix, Aconiti Radix, Olibanum, and Myrrha contained in Hehe pills.
  • Du Xueting, Zhu Xiaoli, Gao Lingna, Sun Hongshuang, Ma Hongfang
    Adverse Drug Reactions Journal. 2022, 24(3): 162-164. https://doi.org/10.3760/cma.j.cn114015-20210330-00390
    A 66-year-old female patient regularly received nifedipine sustained release tablets 20-mg twice daily and captopril 25-mg once daily by mouth for 2 years due to hypertension. Low blood glucose (3.0-mmol/L) appeared in recent 1 year, frequent hypoglycemic coma occurred in recent 4 months. Laboratory tests showed minimum fasting glucose 1.6-mmol/L, insulin 12 mU/L, C-peptide 1.78-nmol/L, and positive anti-insulin antibody. Insulin autoimmune syndrome was considered, which might be associated with captopril. Then captopril was stopped, nifedipine sustained-release tablets was continued, irbesartan hydrochlorothiazide was added, and prednisone 30-mg orally once daily was given at the same time. In addition, the patient was asked to adjust diet, including low carbohydrate and eating less and often. After stopping captopril for 3 days, her blood glucose was between 4.3 to 11.2-mmol/L, and hypoglycemia did not recur.
  • 病例报告
    . 2004, 6(1): 47-48.
  • An Xiang, Gao Jingfei, Sun Jieyu, Wang Ziyi, Wu Xiaomei, Ding Xuansheng
    . 2017, 19(1): 44-51.
    ObjectiveTo investigate the "dose-time-toxicity" relationship of liver injury in mice induced by multiple dose of Chaiqin Qingning Capsule and Ganmaoling capsule.MethodsThree hundred and ten healthy SPF mice were divided into 7 groups randomly, in which 3 groups were low, medium and high dose subgroups of Chaiqin Qingning capsule (50 mice with male and female half in each subgroup). The doses of Chaiqin Qingning capsule subgroups were 1 437.70, 2 300.31 and 3 680.50 mg/kg, which were 1.63, 1.64 and 1.65 times of clinically equivalent dose (ED) respectively. Three groups were low, medium and high dose subgroups of Ganmaoling capsule (50 mice with male and female half in each subgroup). The doses of Ganmaoling capsule subgroups were 1 452.31, 2 251.08 and 3 489.18 mg/kg, which were 1.553, 1.554 and 1.555 times of ED respectively. One group was the normal control group(10 mice, half were male). Each subgroup mice were treated with intragastric administration of the corresponding concentration drug suspension by 0.20 ml per 10 g body weight, and the normal control group mice were treated with intragastric administration of equal volume of distilled water. All mice were treated once daily for 14 days. The general state of mice in each group was observed during the experiment. Ten mice randomly selected on the 1st, 3rd, 7th, 11th and 14th day after multiple administration of the medicine in each subgroup respectively and 10 mice in the normal control group after 14 days multiple administration of distilled water were weighed, and the serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), albumin (ALB) and total bilirubin (TBil) levels were tested. Then the mice were executed and the organs, i.e., liver, thymus, and spleen were taken to weigh and calculate the organ index.ResultsThe general state of mice in the normal control group, Chaiqin Qingning capsule subgroups and Ganmaoling capsule low dose subgroup were not abnormal during the administration period. Ganmaoling capsule high dose subgroup appeared 8 mice died within 1 day after first administration, the overall mortality rate was 16%. The high dose and medium dose subgroup of mice showed decrease in activities, dietary, water and body weight significantly on 1st to 3rd day. The symptoms gradually disappeared on 4th to 7th day, and the state gradually returned to normal on 8th to 14th day. The difference of serum level of ALT, AST, ALP, ALB, TBil and liver, thymus and spleen organ index of Chaiqin Qingning capsule subgroups and Ganmaoling capsule low dose subgroup on the 1st, 3rd, 7th, 11th and 14th days after multiple administration compared with those of the normal control group were not statistically significant (all P>0.05). The levels of serum ALT, ALP and TBil of Ganmaoling capsule high dose subgroup mice after multiple administration on 1st, 3rd, 7th day and the serum AST of mice on 1st and 3rd day were significantly higher than those in the normal control group (P<0.05, P<0.01). The serum ALB level of Ganmaoling capsule high dose subgroup mice on 3rd, 7th, 11th and 14th day were significantly lower than those in normal control group (P<0.05, P<0.01). The levels of serum ALT, AST, ALP and TBil of Ganmaoling capsule medium dose subgroup mice after multiple administration on 1st and 3rd day were significantly higher than those in the normal control group (P<0.05, P<0.01). The serum ALB level of Ganmaoling capsule medium dose subgroup mice after multiple administration on 3rd and 7th day were significantly lower than those in normal control group (P<0.05, P<0.01). The liver organ index of mice in Ganmaoling capsule high dose subgroup after multiple administration on 1st , 3rd and Ganmaoling capsule medium dose subgroup after multiple administration on 1st day were significantly higher than that in the normal control group (all P<0.01).ConclusionsMultiple intragastric administration of Chaiqin Qingning capsule in different doses did not induce significant hepatotoxicity. Multiple intragastric administration of Ganmaoling capsule in medium dose or high dose could induce hepatotoxicity in mice, and showed an obvious "dose-time-toxicity" relationship.
  • Fan Qingqing, Xie Han, Yan Tianhua, Ge Weihong
    . 2018, 20(2): 135-139.
    Oxcarbazepine (OXC) is a new antiepileptic drug developed through structural variation of carbamazepine and widely used for the patient who cannot tolerate carbamazepine. Although OXC has a lower risk of cutaneous adverse drug reactions (cADRs) than carbamazepine, it has been reported that OXC-induced cutaneous adverse drug reactions (OXC-cADRs) are prevalent and may lead to drug discontinua-tion. HLA-B*15:02 is associated with oxcarbazepine-induced SJS/TEN, but not maculopapule, which is similar to carbamazepine. In addition, HLA-A*13:02, HLA-B*38:02 and HLA-B*40:02 are HLAⅠtype genes which is related to oxcarbazepine-induced maculopapule (OXC-MPE), and HLA-DRB1*04:03 was first HLA class II gene found associated with OXC-MPE. The risk factor of OXC-cADRs is still not completely clear. Age, gender, weight and total dose of medication were not correlated with OXC-MPE. Allergy induced by antiepileptic drugs and non-antiepileptic drug induced allergy may be risk factors of OXC-cADRs. Attention should be paid to cross-allergic reactions before using oxcarbazepine for patients with a history of carbamazepine-induced allergy. Genetic test is not currently recommended in patients with maculopapule. Aromatic antiepileptic drugs should be avoided in patients with positive expression of HLA-B*15:02 gene.
  • Liang Haixia, Meng Fanqiang, Li Peng, Ling Sihai, Guo Wei
    Adverse Drug Reactions Journal. 2019, 21(2): 146-147. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.016
    A 66-year-old female patient received oral sertraline (initial dose 25 mg once daily, gradually increased to 100 mg once daily on day 10), zopiclone (7.5 mg once per night), lorazepam (0.5 mg thrice daily), and amlodipine (2.5 mg once daily) following the doctor′s advice due to recurrent depressive disorder, sleep disorder, and hypertension. Before administration, the patient′s serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and γ-glutamyl transpeptidase (γ-GT) were 21 U/L, 16 U/L and 50 U/L, respectively. On day 16 after the medication, the patient′s serum levels of AST, ALT, and γ-GT were 114 U/L, 134 U/L, and 192 U/L, respectively, but the treatment protocol was not adjusted. On day 21 after the medication, her serum levels of AST, ALT, and γ-GT turned to be 178 U/L, 242 U/L, and 362 U/L, respectively. Then hepatoprotective drugs were given, sertraline was discontinued by gradual reduction (oral escitalopram 5 mg once daily was added when sertraline was reduced to 25 mg once daily, but escitalopram was changed to oral mirtazapine 15 mg at bedtime finally due to the patient′s leg discomfort), and the other drugs were continued. The liver function of the patient gradually improved and her serum levels of AST, ALT, and γ-GT were 35 U/L, 36 U/L, and 108 U/L, respectively about 50 days after sertraline withdrawal.
  • 不良事件
    . 2004, 6(4): 272-272.
  • 病例报告
    . 2002, 4(1): 43-44.
  • 病例报告
    Ma Xuelian;Tao Hai;Han Cui
    . 2008, 10(1): 0-0.

    A 65yearold woman with right glaucoma was instilled with 0.1 ml of latanoprost eye drops. Two hours after administration of the first drop, she developed dyspnoea, cyanosis, and hidrosis. Physical examination showed that her heart rate was 120 beats/min, her blood pressure was 160/100 mmHg, and the wheezing heard from her lungs. The patient was given salmeterol xinafoate and fluticasone propionate powder for inhalation immediately. Her symptoms resolved after ten minutes. Later, latanoprost eye drops was replaced with 1% brinzolamide eye drops. Bronchial asthma did not recur.

  • 系列问答
    . 2009, 11(2): 149-2.
  • 不良事件
    . 2005, 7(5): 387-388.
  • Gao Jian, Qiao Weichao, Xia Qing, Zhang Qing
    Adverse Drug Reactions Journal. 2020, 22(9): 547-549. https://doi.org/10.3760/cma.j.cn114015-20200412-00518
    Two female patients (patient 1, 22-year-old; patient 2, 50-year-old) received IV infusion of ribavirin injection (4 g in the first dose and the next day 1.2 g thrice daily), oral 2 lopinavir and ritonavir tablets twice daily, and aerosol inhalation of recombinant human interferon α2b for injection for novel coronavirus pneumonia. There was no obvious abnormality in blood routine and liver function before treatment. Laboratory tests showed red blood cell count (RBC) 2.89×1012/L, hemoglobin (Hb) 75-g/L, alanine aminotransferase (ALT) 22.8-U/L, aspartate aminotransferase (AST) 33.9-U/L, total bilirubin (TBil) 71.2-μmol/L, and indirect bilirubin (IBil) 63.5-μmol/L in patient 1 on the 2nd day of treatment, and RBC 3.46×1012/L, Hb 95-g/L, ALT 17.7-U/L, AST 21.3-U/L, TBil 86.1-μmol/L, and IBil 67.1-μmol/L in patient 2 on the 3rd day of treatment. The direct antiglobulin test was positive, indirect antiglobulin test was negative, and antinuclear antibody test was negative in both patients. They were diagnosed as having acute hemolytic anemia. Con- sidering the relationship to ribavirin, ribavirin was given in reduced dose and then finally discontinued in patient 1, and was discontinued directly in patient 2. On the basis of continued use of the other 2 drugs, both of them were treated with ursodeoxycholic acid. The Hb and bilirubin level of the 2 patients gradually returned to normal.
  • . 2015, 17(4): 319.
  • ADR监测与防治
    . 2000, 2(2): 109-109.
  • 病例报告
    . 2000, 2(1): 56-57.
  • 病例报道
    . 1999, 1(2): 125-125.
  • ADR咨询
    . 2002, 4(4): 281-281.
  • 病例报告
    DUAN Dan-dan;LI Jian-hua
    . 2012, 14(4): 259-2.
    A 47-year-old female received an IV infusion of aztreonam 1.0 g in 0.9% sodium chloride 250 ml twice daily, an IV infusion of tinidazole 0.4 g twice daily and vaginal administration of one Baofukang (保妇康)suppository once daily for pelvic inflammation. Four days after drug administration, the patient developed asthenia. Laboratory tests revealed the following levels: creatine kinase (CK) 764 U/L, lactate dehydrogenase (LDH) 357 U/L, α-hydroxybutyrate dehydroge nase(α-HBDH) 293 U/L. Aztreonam was withdrawn and her other medications remained unchanged. On the fifth day after aztreonam withdrawal her asthenia improved. She had a CK level of 257 U/L, a LDH level of 351 U/L and a α-HBDH level of 162 U/L. On the ninth day after aztreonam withdrawal, her asthenia disappeared. Her CK(166 U/L), LDH (331 U/L) and α-HBDH (156 U/L) levels were within normal range.
  • 安全信息
    . 2012, 14(4): 223-1.
  • ADR咨询
    . 2006, 8(4): 311-311.
  • Yu Jianliang, Kang Ming, Chen Xiaoyan
    . 2016, 18(4): 277.
    ObjectiveTo understand the clinical characteristics and outcomes of electrocardiogram (ECG) abnormalities induced by risperidone.MethodsMedical records of patients, who had hospitalized in Department of Psychiatry, Hangzhou Fuyang Third People′s Hospital and treated with risperidone for the first time from June 2013 to June 2014, were collected and retrospectively analyzed. The incidences [including the total incidence of ECG abnormalities, incidence in the low dose (<4 mg/d) group and the high dose (4-6 mg/d) group, incidence at different time of treatment (1, 2, 3 months of treatment)], characteristics, treatments, and outcomes of ECG abnormalities were analyzed.ResultsA total of 293 patients were enrolled into this study. Of them, 135 patients (70 males and 65 females with age from 22 to 68) were in the low dose group and 158 patients (77 males and 81 females with age from 24 to 63) were in the high dose group. The total incidence of ECG abnormalities was 39.60% (116/293) and the difference between the low dose and the high dose groups was not statistically significant [37.78%(51/135) vs. 41.14%(65/158),  χ2=0.344, P=0.502]. All ECG abnormalities appeared within 3 months of treatment, the incidences in the 1, 2, and 3 months were 16.72%(49/293), 14.75%(36/244), and 14.90%(31/208), respectively. The incidences in the 1, 2, and 3 months were 16.30% (22/135), 14.16% (16/113), 13.40% (13/97) in the low dose group and 17.09% (27/158), 15.27% (20/131), 16.22% (18/111) in the high dose group, respectively. There were no statistical significance between the 2 groups (all P>0.017) . The incidence of ECG abnormalities was the highest in the first month of treatment in the 2 groups. The main characteristics of abnormal ECG induced by risperidone were sinus tachycardia, sinus tachycardia, sinus arrhythmia, ST-T changes, atrioventricular block, QT interval prolongation, etc. Of the 116 patients with ECG abnormalities, 7 patients′ risperidone treatments were not stopped and no any other treatments were given, 31 patients′ risperidone treatments were not stopped and symptomatic treatments were given, 3 patients were given a lower dosage of risperidone, and 75 patients′ risperidone treatments were stopped. All patients′ ECG returned to normal.ConclusionsSinus arrhythmia was more common in the ECG abnormalities caused by risperidone. ECG abnormalities appeared mostly in the early stage of risperidone treatment, had no significant relationship with the dosage, and could return entirely to normal.
  • Liu Yujing, Zhang Hongmei, Tian Xu
    Adverse Drug Reactions Journal. 2020, 22(12): 715-716. https://doi.org/10.3760/cma.j.cn114015-20200327-00307
    A 58-year-old male patient received intravenous infusion of ceftezole sodium 2 g twice daily for urinary tract infection and prostatitis. About 20-minutes in the first medication, the patient deve- loped transient stuffy, plugged-up sensation and tinnitus in the right ear. After finishing the first IV infusion, the tinnitus in the right ear recurred. About 25-minutes in the second IV infusion of ceftezole sodium, the patient developed tinnitus and stabbing pain in both ears, hearing loss, and dizziness. After consultation with otolaryngologists, the patient was diagnosed as having sudden deafness, which was considered to be caused by drug. Ceftezole sodium was stopped and an IV infusion of alprostadil for injection 10-μg dissolved in 5% glucose injection 100-ml once daily was given. Eight days later, the patient′s symptoms such as tinnitus, earache, hearing loss, and dizziness disappeared.
  • 病例报告
    . 2002, 4(4): 277-277.
  • 病例报告
    . 2000, 2(2): 129-129.
  • 病例报告
    . 2002, 4(4): 263-264.
  • 国外信息
    . 2005, 7(4): 313-314.
  • 论著
    Liu Guiyang;Guo Daihong;Chen Chao;Ma Liang;Zhao Pengzhi
    . 2008, 10(1): 0-0.

    Objective:To investigate the adverse reactions induced by cefoperazone (CPZ) and cefoperazone/sulbactam (CPZ/SB).Methods: Two hundred and twenty case reports of adverse reactions induced by CPZ and CPZ/SB were collected from database of PLA ADRM Centre between January 2001 and December 2006. The 220 cases were divided into following two groups: the CPZ group (115 cases) and the CPZ/SB group (105 cases). The patients in the CPZ and CPZ/SB groups were administered with CPZ 1 g and CPZ/SB (CPZ:SB=1:1) 2 g dissolved in 100200 ml of glucose 5% or sodium chloride 0.9% by intravenously two times daily, respectively. The time of infusion was 30~60 minutes. The clinical types and manifestations, severity, outcome, the effects on patients' original diseases, and the time of onset to adverse reactions were compared between the CPZ group and the CPZ/SB group.Results: The main adverse reactions in the two groups were the same, ie, skin and appendages disorders, allergic reactions, gastrointestinal disorders, and their differences of incidence rate were no statistically significant (P>0.05). The incidence rate of the fatal or serious (sequelae occurring) adverse reactions was higher in the CPZ group than in the CPZ/SB group (0.9% vs. 0, 2.6% vs. 0). The time of onset of adverse reactions was slower in the CPZ/SB group than in the CPZ group [(2.9±4.1) days vs. (1.9±2.1) days]. The vision abnormality (4 cases), hyperglycemia (1 case), and aphasia (1 case) occurred in the CPZ/SB group.Conclusion: The cefoperazone/sulbatan is safer than cefoperazone, but it may induce some special adverse reactions, which should be paid more attention in clinical practice.

  • 病例报告
    Zhang Xianli
    . 2008, 10(1): 0-0.

    A 55yearold man received omeprazole magnesium entericcoated capsules 20 mg once daily for treating duodenobulbar ulcer seven years ago. Fifteen days after administration, he presented with eczema on the medial skin of left leg. The skin lesion resolved after symptomatic therapy. During the subsequent 7 years, he experienced a relapse of eczema following each treatment with the drug. And eczema became chronic. Omeprazole was discontinued due to the aggravation of eczema and replaced with Kuaiwei tablets. Later, eczema was cured after symptomatic therapy. The patient had no a relapse of eczema in the recent two years.

  • 病例报告
    . 2006, 8(4): 301-302.
  • 病例报告
    . 2006, 8(6): 455-456.
  • Shen Wei, Chen Xing, Xia Xiaodong
    . 2016, 18(5): 391.
    A 51-year-old male with pneumonia received IV infusions of ciprofloxacin lactate and sodium chloride injection 0.2 g twice daily and cefuroxime sodium 2.25 g twice daily. On day 2, the patient developed marked scrotal edema, skin surface was bright and not pitting after pressing. Ciprofloxacin lactate and sodium chloride injection was stopped on the same day. Cefuroxime sodium was changed to an IV infusion of cefodizime 2 g twice daily. At noon that day, the scrotal edema was relieved. The scrotal edema disappeared completely in the evening.
  • Lin Huihuang, Zeng Yiming, Chen Xiaoyang, Lin ling
    . 2015, 17(2): 144-145.
    A 22-year-old female patient with hyperthyroidism received propylthiouracil 50 mg twice daily. After 6 months, she presented cough, hemoptysis, a chest CT scan revealed multiple patchy opacities in both lungs. Bronchoalveolar lavage fluid showed bloody pulmonary alveolus. Diffuse alveolar hemorrhage syndrome was diagnosed. On hospital day 9, the biochemical studies indicated serological positive findings for myeloperoxidase-anti-neutrophil cytoplasmic antibody. Propylthiouracil-induced antineutrophil cytoplasmic antibody-associated vasculitis was considered. Propylthiouracil was switched to methimazole, and methylprednisolone was given. After 5 days, the hemoptysis stopped. After 8 days, her lung lesions improved significantly. During one-year follow-up, she had no hemoptysis.
  • 病例报告
    SHI Wei-feng;LI Xiao-yu;LIU Gao-lin
    . 2012, 14(3): 176-2.

    A 64-year-old male patient received thiamazole (10 mg two times every day orally ) and propranolol (10 mg three times every day orally ) for hyperthyroidism. Five days later, the patient developed skin rash with itching which improved after self-taking loratadine. On day 25, dosages of thiamazole and propranolol were adjusted to 10 mg three times daily and 20 mg three times daily, respectively, and he received hepatoprotective treatment as well. On day 9 after adjusting the dosages, the patient developed intermittent and migratory joint pain and limited joint mobility. On day 11, thiamazole was stopped and meloxicam was given. Two weeks after thiamazole discontinuation, his joint pain significantly improved without limited joint mobility.

  • Cheng Jun, Han Yixuan, Wang Long, Zhu Lingna
    Adverse Drug Reactions Journal. 2023, 25(2): 107-111. https://doi.org/10.3760/cma.j.cn114015-20221028-00998
    Crizotinib is a multi-target small molecule tyrosine kinase inhibitor, which can act on anaplastic lymphoma kinase (ALK), cellular-mesenchymal to epithelial transition factor and c-ros oncogene 1 (ROS1). It is mainly used in patients with ALK/ROS1-positive advanced non-small cell lung cancer. Liver injury is one of the most common adverse reactions of crizotinib. The typical symptom of crizotinib-induced liver injury is asymptomatic aminotransferase elevation, and fatal liver failure can occur in very few patients. The mechanism is mainly related to mitochondrial-mediated apoptosis, excessive autophagy, oxidative stress, and anaphylaxis. The risk factors involved are history of liver diseases, hepatitis B virus infection, combined use of immune checkpoint inhibitors or H2-antagonist/proton pump inhibitor, gene polymorphisms of signal transducer and activator of transcription 1 and cytochrome P450. It is very important to assess liver function comprehensively before treatment, and strengthen the therapeutic drug monitoring during treatment. Measures such as temporary (reduce the dose when re-use) or permanent discontinuation should be taken when necessary.
  • Zhao Simiao, Sheng Xiaoyan, Shen Jianghua, Zhou Ying
    Adverse Drug Reactions Journal. 2024, 26(10): 577-583. https://doi.org/10.3760/cma.j.cn114015-20240724-00628
    With the spread of hemodialysis therapy and the continuous breakthrough of kidney transplantation technology, the survival period of patients with end stage renal disease is prolonged, and malignant tumor has become one of the main causes for hospitalization and death of patients on hemodialysis and undergoing kidney transplantation. Due to the particularity of pharmacokinetics in patients on dialysis and the long term maintenance immunosuppressive therapy in kidney transplant patients, many aspects need to be considered and balanced in these patients when they need anti tumor drug treatments. The Japanese Society of Nephrology, Japan Society of Clinical Oncology, Japanese Society of Medical Oncology, and Japanese Society of Nephrology and Pharmacotherapy have jointly formulated Clinical Practice Guidelines for Management of Kidney Injury During Anticancer Drug Therapy 2022, and systematically answers many clinical questions about anticancer drug therapy in patients on hemodialysis and underwent kidney transplantation in the second chapter. This article interprets this part to provide references for the anti-tumor drug treatments of patients on dialysis and after kidney transplantation in China.
  • Yang Lili, Zhao Qun, Si Jigang, Cui Ran, Xu Lili
    Adverse Drug Reactions Journal. 2024, 26(11): 683-688. https://doi.org/10.3760/cma.j.cn114015-20240419-00273
    Objective To analyze the clinical characteristics and treatments of adverse reactions and anaphylaxis induced by cisatracurium besylate, and provide reference for medication safety in clinic. Methods Adverse reaction reports of cisatracurium besylate in database of Shandong Provincial Center for Adverse Drug Reaction Monitoring between January 1, 2008 and April 18, 2023 were collected and analyzed retrospectively. The adverse reaction terminology was standardized using the preferred terms and system organ class (SOC) in the Medical Dictionary for Regulatory Activities 25.1. The cases of anaphylaxis were selected and graded. The characteristics of all anaphylaxis and treatments of anaphylaxis of grade Ⅱ-Ⅳ were analyzed. Results A total of 163 adverse reaction reports were included for analysis, involving 201 preferred terms. The top 3 SOCs involved were mainly skin and subcutaneous tissue disorders (133 cases, 66.17%), vascular disorders (14 cases, 6.96%), and immune system disorders(14 cases, 6.96%). One hundred and forty-five patients (89.0%) experienced anaphylaxis, mainly within 10 minutes after medication (115 cases, 79.3%). Of them, 37 (25.5%) patients had anaphylaxis of grade Ⅱ-Ⅳ. The most common initial symptom was circulation system symptoms (19 cases, 51.4%), followed by skin or mucosal signs (12 cases, 32.4%). The main therapeutic drugs included glucocorticoids (27 cases, 73.0%), adrenaline (17 cases, 45.9%), and other vasopressors other than adrenaline (19 cases, 51.4%). All patients showed improvement or recovery in symptoms after treatments. Conclusions The anaphylaxis caused by cisatracurium besylate mainly occurred within 10 minutes after medication and have a good prognosis. For anaphylaxis classified as grade Ⅱ-Ⅳ, the acute phase treatment drugs mainly include glucocorticoids, adrenaline, and other vasopressors other than adrenaline.
  • Xiao Ran, Du Xiaoli, Li Taisheng
    Adverse Drug Reactions Journal. 2025, 27(1): 36-43. https://doi.org/10.3760/cma.j.cn114015-20240402-00219
    Antiretroviral therapy (ART) significantly improves the survival rate and quality of life of patients with human immunodeficiency virus (HIV) infection. However, with the extension of patients′ survival time, drug-induced new health problems such as blood glucose increase, dyslipidemia, and weight gain are becoming prominent. Different antiretroviral agents have different effects on blood glucose, blood lipid and adipose tissue. This paper reviews the research progress on effects of nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase inhibitors on blood glucose, lipid metabolism and body weight in HIV-infected people in recent years, and puts forward corresponding control suggestions.
  • ADR咨询
    . 2001, 3(3): 211-211.
  • WHO信息
    . 2004, 6(1): 63-63.
  • Li Jing, Ge Yunjie, Jia shaodan, Xiao Zhixiu
    . 2018, 20(3): 193-197.
    ObjectiveTo evaluate the efficacy and safety of fosfomycin-trometamol (FMT) in the treatment of acute uncomplicated lower urinary tract infection (LUTI).MethodsThe medical records of acute uncomplicated LUTI patients, who had acute uncomplicated LUTI and received FMT or levofloxacin (LEV) in Qingdao Municipal Hospital from January 2015 to October 2017, were collected and analyzed retrospectively. Comparisons were made between the FMT group and the LEV group to investigate the patients' clinical efficacy, bacteriological efficacy, bacteria isolated from urine cultures, the susceptibility of isolated strains to drugs and the occurrence of adverse reactions.ResultsSeventy patients entered the FMT group, including 31 males and 39 females, aged from 29 to 68 years with an average age of (51±10) years.56 patients entered the LEV group, including 26 males and 30 females, aged from 31 to 66 years with an average age of (52±10) years.The treatment periods of patients in the two groups were 3 to 7 days. Routine blood tests and liver and renal function tests were normal before the treatment. After the treatments, 59 patients were cured, 5 patients improved, and the clinical efficacy was 91.4% (64/70) in the FMT group; while 28 patients were cured, 4 patients improved, and the clinical efficacy was 57.1% (32/56) in the LEV group. And the difference was statistically significant (χ2=20.16, P<0.001). Positive bacteria were found in urine culture of 46 patients in the FMT group, including 35 strains of Escherichia coli[17 of which were extended-spectrum β-lactamases (ESBL)-producing Escherichia coli], 3 strains of Bacillus proteus [1 of which was ESBL-producing Bacillus proteus], 3 strains of Enterococous faecalis, 3 strains of Staphylococcus aureus, and 2 strains of Staphylococcus epidermidis. Positive bacteria were found in urine culture of 37 patients in the LEV group, including 29 strains of Escherichia coli (14 of which were ESBL-producing Escherichia coli), 3 strains of Bacillus proteus (1 of which was ESBL-producing Bacillus proteus), 2 strains of Enterococous faecalis, 1 strain of Staphylococcus aureus, and 2 strains of Staphylococcus epidermidis. Bacteriological efficacy were 91.3% and 56.8%, for the FMT group and the LEV group, respectively and the difference was statistically significant (χ2=13.38, P<0.001). Thirteen of the 17 ESBL-producing Escherichia coli strains isolated from patients in the FMT group were susceptible to FMT (susceptibility rate: 76.5%). Five of the 14 ESBL-producing Escherichia coli strains isolated from patients in the LEV group were susceptible to LEV (susceptibility rate: 35.7%). And the difference was statistically significant (P=0.033). The difference of the incidence of adverse reactions was not statistically significant between the FMT group and the LEV group [11.4% (8/70) vs 16.1% (9/56), χ2=0.575, P=0.448].ConclusionFMT was more effective and safer than LEV in the treatment of patients with acute uncomplicated LUTI.
  • WHO信息
    . 2004, 6(6): 423-423.
  • 病例报告
    . 2006, 8(3): 210-211.
  • 病例报告
    . 2002, 4(1): 46-47.
  • 不良事件
    . 2002, 4(5): 345-345.
  • 抗菌药应用
    . 2004, 6(6): 393-393.
    抗菌药物不合理应用引致的危害已受到普遍关注。日前,卫生部、国家中医药管理局、总后卫生部共同发布的《抗菌药物临床应用指导原则》对合理应用抗菌药物、保障患者用药安全有效具有十分重要的意义。本刊现将该“指导原则”的施行通知、前言及其主要内容介绍如下,之后,将连载其具体内容以飨读者。
  • SARS防治
    . 2003, 5(3): 147-147.
  • 病例报告
    . 2000, 2(2): 125-126.
  • ADE简报
    . 2000, 2(2): 130-130.
  • Gao Zhenzhen, Song Yuguo
    . 2018, 20(1): 76.
    A 27-year-old female patient visited private clinic because of  irregular menses. The private clinic pharmacist dispensed by mistake Shidudan (湿毒丹) containing lead powder 31 g and minium 62 g as Sanqifen (三七粉) to the patient. The patient developed abdominal pain, vomiting, fatigue and dark-red urine 2 hours after taking 2 spoons of Shidudan (containing about lead powder 4 g and Pb3O4 8 g) mistakenly. Two days later, the patient′ symptoms mentioned above became serious and developed scleral and mucocutaneous yellow staining. The laboratory tests showed the following results: blood lead level 8.38 μmol/L, hemoglobin (Hb) 89 g/L, alanine aminotransferase (ALT) 4 707U/L, aspartate aminotransferase (AST) 5 363U/L, lactate dehydrogenase (LDH) 2 988U/L, total bilirubin (TBil) 371.4 μmol/L, direct bilirubin (DBil) 184.30 μmol/L and indirect bilirubin (IBil) 187.1 μmol/L, urine lead level 4.87 μmol/L, urinary red blood cells (++), urinary bilirubin (++), urobi-linogen  (+++). Her urine was brown in color. The patient was diagnosed as acute lead poisoning, acute toxic liver disease (severe), acute hemolysis, and severe hemolytic anemia. Thepatient received the com-bined treatments including plasmapheresis,  eliminating lead by calcium disodium edetate, and infusion of red blood cell. Fifty-seven days later, the patient′ symptoms of jaundice in sclera, skin and mucosa, abdominal pain, and vomiting disappeared. Her urine became clear. The results of laboratory tests showed the following: blood lead level 0.75 μmol/L, Hb 112 g/L, ALT 32 U/L, AST 32 U/L, LDH 174 U/L,TBil 23.1 μmol/L, DBil 13.7 μmol/L, and IBil 9.4 μmol/L.
  • Wang Jiabo, Song Haibo, Ning Keyong
    . 2018, 20(6): 409-412.
  • Xu Dongming, Lin Ling
    . 2015, 17(5): 387.
    A 20-year-old female patient received oral propylthiouracil (PTU) 100 mg/d for hyperthyroidism. After 2 years, she noticed blood in phlegm and had red eye. PTU-associated vasculitis was diagnosed. PTU was stopped and oral prednisone 20 mg/d was given. Her symptoms improved. Twenty days later, prednisone dosage was reduced to 5 mg/d, hemoptysis appeared again with swelling in the left ear. Laboratory testing showed the following results: free triiodothyronine 5.78 pmol/L, free thyroxine 2.69 pmol/L, thyroid-stimulating hormone 0.007 mU/L, antinuclear antibody 1 ∶  320 (+), spotted type, perinuclear anti-neutrophil cytoplasmic antibodies (p-ANCA) (+), myeloperoxidase(MPO)79.3 RU/ml, proteinase 3(PR3)2.2 RU/ml. Chest CT shows multiple patchy opacities in both lungs. PTU induced anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis and hyperthyroidism were diagnosed. IV infusion of methylprednisolone 40 mg/d and oral methimazole 5 mg/d were given. Hemoptysis and auricle swelling subsided after one week. Methylprednisolone was switched to oral prednisone. One year later, prednisone was stopped without physician′s advise. Five months later, recurrence of hemoptysis occurred. Laboratory testing showed p-ANCA (+), MPO 72.0 RU/ml, and PR3 2.0 RU/ml. ANCA-associated vasculitis recurrence was considered. Methimazole was stopped and IV infusion of methylprednisolone 40 mg/d was given. Hemoptysis was alleviated obviously after one week and oral prednisone was continued. Five months later, red maculopapule appeared on her right auricle. MPO was 112.0 RU/ml. Oral methotrexate 10 mg once weekly was added. Red maculopapule faded and MPO was reduced to 78.0 RU/ml after 6 months. Methotrexate was withdrawn.
  • ADR咨询
    . 2006, 8(2): 154-154.
  • Chen Lizhen, Chen Xiufen, Yang Xuemei
    Adverse Drug Reactions Journal. 2024, 26(7): 440-441. https://doi.org/10.3760/cma.j.cn114015‑20230920‑00688
    A 60‑year‑old male patient with lumbar disc herniation and sciatica received SanqiShangyao 3 tablets thrice daily orally by himself. After 6 days of administration, the patient developed upperabdominal stuffy pain, nausea, vomiting, and yellowish skin. Laboratory tests showed total bilirubin (TBil)155.2 μmol/L, direct bilirubin (DBil) 87.1 μmol/L, alanine aminotransferase (ALT) 817 U/L, aspartateaminotransferase (AST) 367 U/L, and alkaline phosphatase (ALP) 136 U/L. The concentration of γ‑glutamyltransferase (GGT) was 455 U/L. The drug was stopped, liver protective treatments were given for 8 days, andthe above symptoms in the patient were improved; after 38 days of treatments, laboratory tests showed TBil27.3 μmol/L, DBil 9.3 μmol/L, ALT 46 U/L, AST 28 U/L, ALP 83 U/L, and GGT 55 U/L. The patient′s liverinjury was possibly related to the aconitine contained in the Radix Aconiti Kusnezoffii and Aconitumracemulosum Franch of Sanqi Shangyao tablets.
  • Shi Jinping, Li Wei
    Adverse Drug Reactions Journal. 2021, 23(10): 559-560. https://doi.org/10.3760/cma.j.cn114015-20210106-00017
    A 2-year-old boy with left nephroblastoma was treated with parenteral nutrition (including medium/long chain fat emulsion injection, ω-3 fish oil fat emulsion injection, etc.) before radical left nephrectomy because he was unable to eat. The blood biochemical tests before treatment showed triacylglycerol (TG) 1.18-mmol/L, total cholesterol (TC) 2.68-mmol/L, high density lipoprotein cholesterol (HDL-C) 0.80-mmol/L, and low density lipoprotein cholesterol (LDL-C) 1.48-mmol/L. After 7 days of treatment, blood biochemical tests showed TG 4.28-mmol/L, TC 5.48-mmol/L, HDL-C 1.32-mmol/L, and LDL-C 3.74-mmol/L. Dyslipidemia caused by excessive parenteral nutrition was considered. Medium/long chain fat emulsion injection was stopped. Two days later, the blood biochemistry tests showed TG 3.34-mmol/L, TC 3.17-mmol/L, HDL-C 0.86-mmol/L, and LDL-C 2.67-mmol/L; 7 days later, all blood biochemical indexes returned to normal.
  • Cheng Shuqiao, Yin Tao
    Adverse Drug Reactions Journal. 2022, 24(3): 152-155. https://doi.org/10.3760/cma.j.cn114015-20210723-00819
    A 52-year-old female patient with gastrointestinal stromal tumor received imatinib 0.4 g once daily after surgery. Approximately 5 months of imatinib treatment, the patient developed nausea, vomiting, fatigue, and yellowish skin. Laboratory tests showed alanine aminotransferase (ALT) 388-U/L, aspartate aminotransferase (AST) 336-U/L, and total bilirubin (TBil) 32-μmol/L. Drug-induced liver injury was considered and imatinib was discontinued. Further examination showed albumin 29.5-g/L, HBV DNA 3.57×106 IU/ml, and prothrombin activity (PTA) 21%. Abdominal enhanced CT showed peritoneal effusion. The patient was a chronic HBV carrier with negative e antigen (more than 20 years). Combined with the above examination results, the patient was diagnosed as acute-on-chronic liver failure, which is probably to be caused by HBV reactivation induced by imatinib. After 24 days of treatments with antivirus drugs, liver-protective drugs, and artificial extracorporeal liver support, the patient′s ALT was 25-U/L, AST was 39-U/L, TBil was 165-μmol/L, and HBV DNA was 659 IU/ml. About 5 months later, the patient′s liver function returned to normal, with HBV DNA 262 IU/ml.
  • Shao Miaomiao, Sun Ximu, Zhou Han, Li Ying, Sun Yixin, Yang Changqing, Wang iaoling, Zhao Wen
    Adverse Drug Reactions Journal. 2023, 25(10): 592-600. https://doi.org/10.3760/cma.j.cn114015-20231016-00737
    Objective To understand the adverse event (AE) risk signals of 3 anti-disialoganglioside 2 (GD2) monoclonal antibodies, including dinutuximab, dinutuximab beta, and naxitamab, and to provide reference to clinical use. Methods AE reports with dinutuximab, dinutuximab beta, and naxitamab as the primary and secondary suspect drug were collected from the US FDA Adverse Event Reporting System (FAERS) database during 2015 to the 2nd quarter of 2023. AEs were standardized and classified according to the preferred term (PT) and system organ classification (SOC) in the International Medical Terminology Dictionary, Version 25.0, and AE risk signals were mined using the reporting odds ratio (ROR) method and information component (IC) method. The AE reports information and AE risk signals of 3 GD2 monoclonal antibodies were descriptively analyzed. Results A total of 630 AE reports were collected, in which the 3 GD2 monoclonal antibodies were the primary and secondary suspect drugs, including 465 reports of dinutuximab, 61 reports of dinutuximab beta, and 104 reports of naxitamab, which involved 341, 24, and 125 PTs and mapped to 19, 2, and 12 SOCs, respectively. The AEs of the 3 GD2 monoclonal antibodies were associated with the occurrence of death, life-threatening, hospitalization, or prolonged hospitali- zation adverse outcomes. Signal mining using ROR and IC methods detected a total of 142, 3, and 30 AE risk signals, of which 73, 0, and 6 were not documented in the corresponding drug instructions, respectively. The top PTs in report number were fever for both dinutuximab and dinutuximab beta, and hypotension and pain for naxitamab; the top PTs in signal intensity were puncture site abscess, device related bacteraemia, and wheezing for dinutuximab, dinutuximab beta, and naxitamab, respectively. The overlapping AE risk signals for the 3 drugs were fever and pain, with dinutuximab having the strongest signal intensity for fever and naxitamab having the strongest signal intensity for pain. Among the top 30 PTs in report number, naxitamab had significantly more AE risk signals than dinutuximab in respiratory, thoracic, and mediastinal disorders, skin and subcutaneous tissue disorders, immune system disorders, and vascular disorders. For naxitamab, the PTs that differed from dinutuximab′s AE risk signals and were not documented in the naxitamab drug instructions were respiration abnormal, cyanosis, and metabolic acidosis. Conclusions Fever, pain, and hypotension are common AEs for the 3 GD2 monoclonal antibodies. Naxitamab causes significant pain; respiration abnormal, cyanosis, and metabolic acidosis are AE risk signals specific to naxitamab and not documented in the drug instruction, which warrant clinical vigilance and prompt intervention.
  • Adverse Drug Reactions Journal. 2018, 20(1): 48-52. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.01.010
  • Gao Jie, Chen Ruihuan, Zheng Xiaoxian
    Adverse Drug Reactions Journal. 2019, 21(6): 441-442. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.008
    A 51-year-old female patient with lymphadenoma developed neutrophil deficiency with fever after chemotherapy. Voriconazole 1.0 g twice daily was given orally following the doctor’s advice (the recommended dose by drug label is 0.2-0.4g twice daily).  the patient took voriconazole 3 times with total dose of 3.0 g within 24 hours. The medication error was found by a pharmacist and voriconazole was stopped. The voriconazole blood concentrations after 12, 24, 36, and 48 hours of drug withdrawal were 12.20, 10.20, 6.55, and 4.45 mg/L, respectively. The laboratory tests showed alanine aminotransferase (ALT) 11 U/L, aspartate aminotransferase (AST) 6 U/L, and γ-glutamyl transpeptidase (γ-GT) 44 U/L before medication and ALT 327 U/L, AST 153 U/L, andγ-GT 627 U/L after 2 days of drug withdrawal, respectively. Overdose of voriconazole-induced liver injury were considered. The patient received the liver-protective therapy including an IV infusion of compound glycyrrhizin injection and oral bicyclol. After 3 days of drug withdrawal, the voriconazole blood concentration was 0.67 mg/L and the laboratory tests showed ALT 191 U/L, AST 31 U/L, and γ-GT 522 U/L. After 16 days of drug withdrawal, the laboratory tests showed 24 U/L, 15 U/L, and 224 U/L, respectively.
  • 病例报告
    . 2003, 5(6): 400-401.
  • 病例报告
    . 2005, 7(3): 214-215.
  • 病例报告
    . 2002, 4(4): 264-265.
  • 药物警戒
    . 2002, 4(2): 91-91.
  • ADR监测
    . 1999, 1(2): 113-113.
  • 不良事件
    . 2006, 8(1): 65-66.
  • 病例报告
    . 2006, 8(2): 135-136.
  • SARS防治
    . 2003, 5(5): 290-291.
  • 中毒救治
    Du Xuqin;Song Yuguo
    . 2008, 10(1): 0-0.

    Mercury poisoning is usually misagnosed because of insidious onset, nonspecific signs and symptoms, and lack of knowledge within the medical profession. This paper reported a prolonged misdiagnosed case of mercury poisoning to bring attention of it in clinical practice. A 10yearold girl presented with a loss of consciousness secondary to seizure attack. An Examination showed that she has red painful hands with blood pressure 150/90 mmHg. There were audible (grade Ⅲ/Ⅵ) machinery murmurs along the left sternal margin in the 2nd to 3 rd intercostal spaces. Abnormal high signal change was found within subcortical regions of the frontal, partietal, temporal, and occipital lobes on FLAIR image . Her plasma rennin angiogenesis and aldosterone levels were obviously elevated. Her mercury concentration in the urine was 0.17 mg/L before treatment. After treatment with dimercaprol, the girl's blood pressure returned to normal limits, seizures and other symptoms diappeared. Tracing her history, she was exposed to elemental mercury for playing with her classmates in the last 2 months.

  • 论著
    Hou Shaozhen;Li Geng;Lai Xiaoping;Ye Murong;Chen Jiannan;Su Ziren*
    . 2008, 10(1): 0-0.

    objectine:To study the mechanism of hemolysis induced by puerarin injection. Methods: Hemolysis tests in vitro and vivo were performed with puerarin injection in Beagle dogs and guinea pigs as follows: the hemolytic effects of solvent propylene glycol and pH value of the preparation on red cells of Beagle dogs; the effects of IV puerarin on the levels of SOD and MDA of guinea pigs, and hemolytic rates of red cells of sensitized guinea pigs; and the influences of puerarin injection on hemolytic effects and morphological change of red cells of Beagle dogs and guinea pigs.Results: The hemolysis of Beagle dogs’red cells occurred with puerarin in maximum concentration (10 g/L) and pH 4.48, and it did not occur with sodium chloride 0.9%, which had the same pH value as the former. The hemolysis of Beagle dogs’red cells occurred with puerarin injection containing propylene glycol 5% or 10%, and it did not occur with propylene glycol solution 5% or 10%. The level of MDA was marked decreased in the puerarin injection group compared with the sodium chloride 0.9% group (P<0.01). The hemolytic rates of red cells was not increased, and antigenantibody complex was not found in guinea pigs before and after sensitization with puerarin injection. Red cells of guinea pigs were shrunk or broken. The non-immune hemolysis tests in vitro showed that the hymolysis of red cells of Beagle dogs and guinea pigs occurred with puerarin injection, and it was related to the dosage.Conclusion: Puerarin injectioninduce hemolysis is a non-immue one, it may relate to its direct action on red cells and lead to changes in the stability of cells.

  • 安全信息
    . 2008, 10(5): 0-0.
  • Fu Xuewei, Ma Xin, Wan Yungao
    As the secondary preventive drug for cardiovascular and cerebrovascular diseases, statins can significantly improve the prognosis of patients with myocardial infarction and cerebral infarction. However, the investigations on the application of statins showed that statin withdrawal and dose reduction are very common in patients with acute myocardial infarction and cerebral infarction. After 6 months of treatment, patients with good adherence were less than 60%. With the prolongation of treatment time, the proportion of patients with poor adherence or discontinued treatment gradually increased. The decline of adherence to statin therapy was related to many factors, such as patients′ concern about drug safety, insufficient communication between doctors and patients, excessive combination of drugs, and economic status and educational levels of patients. Adherence to statin therapy could affect markedly the prognosis of atherosclerotic cardiovascular disease and poor statin adherence could increase the incidence of major adverse cardiovascular events. It is necessary to improve the physician′ awareness of importance of statin therapy, strengthen the education of medication adherence, rationally select treatment drugs, monitor adverse drug reactions, and enhance patients′  adherence to statin therapy.
  • Adverse Drug Reactions Journal Agency
    Adverse Drug Reactions Journal. 2020, 22(9): 497-498. https://doi.org/10.3760/cma.j.cn114015-20200911-00953
  • Ji Zongfei, Jiang Lindi
    . 2015, 17(2): 146-147.
    A 23-year-old woman took propylthiouracil (50 mg in the morning and 25 mg at night alternates with 50 mg in the morning) and levothyroxine sodium (12.5 mg once daily) for Grave′s disease. Three years later, the patient presented with urine occult blood, however, her symptoms did not attract attention. Five months later, the patient developed soy-colored urine and vague pain in the left lower quadrant of the abdomen. Laboratory examination showed the following results: urine protein (++), red blood cell (++++), white blood cell (+), perinuclear anti-neutrophil cytoplasmic antibodies (ANCA) (+), cytoplasmic ANCA (+), proteinase 3 (PR3) 27.9 RU/ml, myeloperoxidase (MPO) >200 RU/ml. She was considered as PTU-induced ANCA associated vasculitis with glomerulonephritis and urinary tract infection. PTU and levothyroxine sodium were stopped. Her chest CT scan exhibited interspersed inflamma-tion, and kidney biopsy result further verified vasculitis. She received methylprednisolone pulse therapy and mycophenolate mofetil. After 7 months, her urine routine test showed  normal results, perinuclear ANCA (+), cytoplasmic ANCA (-), MPO >200 RU/ml, and PR3 was 2.0 RU/ml. her laboratory results showed perinuclear ANCA (+), MPO 143 RU/ml 23 months later.
  • Chen Yuan;Geng Jianghui;Yang Shibin;Zhang Huifeng
    . 2015, 17(1): 64-2.
    An 8-year-old boy underwent a penicillamine provocation test to confirm the diagnosis of hepatolenticular degeneration. Before the test, the laboratory examination showed the following levels: white blood cell count 8.3×109/L, neutrophil 6.0×109/L, hemoglobin 101 g/L, and platelet count 120×109/L. And 24 hours after oral penicillamine 250 mg once, the levels of his white blood cell count, neutrophil, hemoglobin, and platelet count were 1.6×109/L, 0.6×109/L, 105 g/L, and 92×109/L, respectively. The child was given oral prednisone 10 mg twice daily and two tablets of Diyu Shengbai (地榆升白片) twice daily. Five days later, the re-examination showed his white blood cell count of 3.5×109/L with neutrophil of 1.9×109/L, the hemoglobin level of 108 g/L, and the platelet count of 88×109/L。
  • Yu Wenjun, Qiu Cuiting, Shen Nan, Zhang Quanchu, Li Na
    . 2017, 19(3): 222.
    A 68-year-old female patient with rheumatic heart disease and auricular fibrillation received warfarin (10.5 mg per week, totally 6 weeks; then 12 mg per week, totally 3 weeks). The international nomalized ratio (INR) was monitored regularly. Her INR was steady and reached the standard during the medication. She took Zhisou Lixiao Wan 12 g daily by herself because of cough on the 10th week. Four days later she found multiple ecchymosis at her front of right leg and the INR was 6.46. Warfarin was withdrawn while Zhisou Lixiao Wan was continued. Three days later, the ecchymosis was absorbed obviously and the INR decreased to 2.96. Zhisou Lixiao Wan was stopped and warfarin was taken by 12 mg weekly. Five days later, her INR was 2.24 and the ecchymosis disappeared completely.
  • ADR咨询
    . 2006, 8(4): 311-311.
  • Adverse Drug Reactions Journal. 2024, 26(6): 382-383. https://doi.org/10.3760/cma.j.cn114015-20240618-00463
  • Zhang Yunxia, Qin Qianqian, Zhao Ruiling, Wang Xiaoling
    Adverse Drug Reactions Journal. 2024, 26(9): 557-562. https://doi.org/10.3760/cma.j.cn114015-20240202-00075
    Objective To investigate the reasons for contraindication of chemical drugs and biological products that were marked as contraindication for children in drug labels in China. Methods The drugs labeled as contraindication for children in drug labels of chemicals and biological products covered by the China Pharmacopoeia 2020 and the 2023 China′s Basic Medical Insurance, Work?related Injury Insurance and Childbirth Insurance (western medicine) were searched. The reasons of contraindication for children were collected through searching the drug labels, Clinical Medication Instructions of the China Pharmacopoeia 2020, the website of the National Medical Products Administration, and drug labels from the Unite States, and analyzed descriptively. Results There were 222 drugs were labeled as contraindication for children in the drug labels, involving 20 categories and mainly antibiotics and digestive system drugs. Among 222 drugs, 137(61.7%) had the reasons for contraindication in pediatric patients, and the main reasons were adverse drug reactions (65.7%, 90/137) and lack of effectiveness and safety information yet in children (30.7%, 42/137), followed by the unsafe auxiliary materials (1.5%, 2/137), unsuitable pres- cription design or ingredients for children (1.5%, 2/137) and unsuitable dosage form for children (0.7%, 1/137). The above reasons were collected from domestic drug instructions (100 drugs), U.S. drug labels (17 drugs), NMPA website instructions revision announcements and popular science knowledge (15 drugs), and Clinical Medication Instructions of the China Pharmacopoeia 2020 (5 drugs). Conclusions It is relatively common in China to label drugs that are contraindicated for children without specifying the reasons for contraindication or with non?standard explanations in the instructions. Therefore, it is necessary to further standardize the contraindication information for children and apply continuous updates and improvement in order to provide timely and up?to?date drug use information for clinical practice.
  • Wang Xiaorui, Mao Jingyuan
    . 2016, 18(5): 394.
    A 39-year-old man with hypertension received amlodipine besylate 5 mg/d. One week later, metoprolol succinate (23.75 mg/d) was added because of  his unstable blood pressure and rapid heart rate. The patient developed frequent  micturition (about 10 times daily) one day after receiving metoprolol succinate,and developed to 10 to 15 times daily gradually. Amlodipine besylate was stopped by himself one weak later. But his frequent micturition did not remit. Two weeks later, metoprolol succinate was stopped by himself. His frequent micturition was relieved one day later (4 to 6 times daily). The patient received metoprolol succinate again according to the doctor′s advice because of his unstable blood pressure. The frequent micturition recurred and remitted again after drug withdrawal.
  • Wen Xiaoyi, Lu Guoyuan, Gao Jie, Qiao Qing, Hang Yongfu
    . 2016, 18(5): 362.
    A 54-year-old woman with systemic lupus erythematosus and lupus nephritis (type Ⅳ) received methylprednisolone 40 mg once daily. She  added up to take  leflunomide 20 mg once daily because of  her positive proteinuria. On day 8 of adding leflunomide, the patient developed high fever, diffuse oral ulcer, red rash (face, neck, both upper extremities, and  chest and abdomen), furfuration and pruritus. Leflunomide was stopped after 7days continuing to take the medication. Laboratory tests on day 15 to 18 of adding leflunomide showed the following results: ESR 20 mm/1 h,Scr 258 μmol/L,ALT 66 U/L,AST 254 U/L,albumin 28.0 g/L,IgM 0.26 g/L,C4 0.16 g/L,C3 0.43 g/L,PLT 66×109/L,urine protein (+++), urine occult blood (+++). She was diagnosed as dermatitis exfoliativa, oral ulcer, acute kidney injury, acute liver injury, and thrombocytopenia. The patient received gargling by nystfungini tablet (2.5 million U) dissolved in 5% sodium bicarbonate solution, spraying by bovine basic fibroblast growth factor aerosol, IV infusions of methylprednisolone 40 mg, reduced glutathione 2.4 g, magnesium isoglycyrrhizinate 150 mg, and alprostadil 20 μg once daily. And inunction of betamethasone cream was done on the surface of erythra. On day 5 of treatment, her pain of oral ulcer was alleviated, the color of erythra at the skin of face, neck, upper limbs, chest and abdomen were appeared light and decrustation. There was no new erythra. Laboratory tests showed the following results: PLT 126×109/L, Scr 83 μmol/L, AST 68 U/L, ALT 153 U/L, albumin 27.0 g/L. On day 9 of treatment, her oral ulcer reccured. There were only a few rashes on her face and neck. Laboratory tests showed the following results: Scr 71 μmol/L, AST 26 U/L, ALT 75 U/L, albumin 27.0 g/L.
  • Wei Huabo, Shu Cheng, Li Lan, Dong Yang
    Adverse Drug Reactions Journal. 2020, 22(1): 50-51. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.01.013
    A 75-year-old male patient received an IV infusion of lappaconitine hydrobromide for injection 4-mg dissolved into 5% glucose injection 250-ml once daily due to bone metastases of lung cancer. After a single time of lappaconitine treatment, the patient developed muscle tremor mainly in the limbs, which was obvious in the sitting and standing positions and disappeared after lying flat. After 2 times of lappaconitine treatment, the muscle tremor was aggravated and he was unable to take care of himself due to tremor, showing that his hands could not hold things and walking was difficult. No other abnormal signs were found except the increase of muscle tension. The extrapyramidal symptoms (Parkinson-like symptoms) induced by lappaconitine was considered. Then lappaconitine was stopped and other treatments continued. About 24-hours of lappaconitine withdrawal, the patient′s muscle tremor disappeared. After 8 days of observation, his symptoms did not recur.
  • Han Shuang, Wu Danwei, Zheng Tingting, Shi Nannan, Zhang Tianjing, Zhang Wei, Zhen Jiancun
    Adverse Drug Reactions Journal. 2019, 21(5): 326-333. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.004
    ObjectiveTo explore the role of chronic disease management led by clinical pharmacists in preventing medication errors in discharged elderly patients with hypertension.MethodsThe subjects were selected from hypertensive patients aged 60-85 years and hospitalized in Department of Cardiology, Beijing Jishuitan Hospital from March 2016 to September 2017. The patients were selected at admission and their basic information were recorded, including gender, age, mode of payment, education level, occupation, and type of combined chronic diseases. The patients were given homogeneous pharmaceutical care by clinical pharmacists during hospitalization and randomly divided into the intervention group and the control group when discharged. After discharge, they were followed up for 24 weeks. The patients in the intervention group were followed up once every 2 weeks from the 1st to the 12th week and once every 4 weeks from the 13th to the 24th week after discharge. The patients in the control group were followed up only once at the end of the 12th and the 24th week after discharge. The follow-up contents included the blood pressure, blood glucose, blood lipids, and other laboratory tests results, name and usage of all the drugs used, on-time medication condition, occurrence of adverse drug reactions, changes in lifestyle, and etc. If the patients were found to have medication errors, the time of error discovery, the content, level, and frequency of the error, and the classification of the drug involved were recorded in a special form. The clinical pharmacists provided individualized medication guidance to patients during the follow-up and gave timely intervention after discovering the medication errors.ResultsForty patients in the intervention group and 44 patients in the control group were entered in the study. There were no significant differences in baseline information between the 2 groups (all P≥0.05). During the 24 weeks of follow-up, medication errors were found in 20 patients in the intervention group and 12 patients in the control group. The difference in detection rate of medication errors between the 2 groups was significant [50.0% (20/40) vs. 27.3% (12/44), χ2=0.043, P=0.032]. A total of 50 cases of medication errors were found in the 2 groups, including 34 (68.0%) in the intervention group and 16 (32.0%) in the control group. During the first 12 weeks of follow-up, 31 cases of medication errors (91.2%) in the intervention group and 8 cases (50.0%) in the control group were found by pharmacists, and the difference was statistically significant (P=0.002). The difference in the proportion of different medication errors classification between the 2 groups was not significant (P>0.05). The drug omission was with the highest proportion in the 2 groups [47.1% (16/34) in the intervention group and 31.2% (5/16) in the control group].Among 50 cases of medication errors, 49 (98.0%) were defined as level 2 errors (with mistake, but no harm), including 20 cases of grade C errors and 29 cases of grade D errors; 1 (2.0%) was defined as level 3 (with mistake and harm) and grade F error. After the intervention of clinical pharmacists, all the level 2 errors were corrected. Level 3 errors led to re-hospitalization of patients. After pharmacists and physicians emphasized the importance of taking medicine according to doctor′s orders again, patients did not make medication errors again. There are 8 categories and 22 kinds of drugs involved in medication errors, including antiplatelet, antihypertensive, hypolipidemic, hypoglycemics, anti-gout, antiarrhythmic, anticoagulant, and anti-angina drugs.ConclusionChronic disease management led by clinical pharmacists is helpful to find and correct the medication errors timely in discharged elderly patients with hypertension.
  • 中药不良反应
    . 2006, 8(5): 393-393.
  • 病例报告
    . 2004, 6(5): 330-331.
    A 69-year-old man was hospitalized with HCV infection. The lab findings showed HCV-RNA 1.88×106copies/ml (normal value<2×102copies/ml),ALT 78U/L.The patient had a history of blood transfusion 400ml due to bronchiectasis with hemoptysis in 1984. Liver function test was abnormal. The man was treated with interferon alfa 3 million units by intramuscular injection daily. He suddenly developed palpitation,dizziness, fever and paleness after taking the medication. Physical examination showed body temperature of 38.8℃, HR 140beats/min and arrhythmia while ECG showed atrial fibrillation. Oxygen and cedilanid 0.4mg were administered. 30 minutes later,the symptoms were lessened and normalized gradually. Arrhythmia did not recur after discontinuing interferon alfa.
  • 不良事件
    . 2003, 5(5): 345-346.
  • Zhao Shenhui, Zhang Li, Yang Hong
    A 68-year-old male patient received apatinib 850 mg orally once daily for advanced gastric cancer with liver and lymph node metastasis despite previous treatments with multiple lines of chemotherapy, which induced myelosuppression. About 1 month after the medication, the patient developed fatigue and poor appetite. Thyroid function tests showed serum free triiodothyronine (FT3), free thyroxine (FT4), and thyroid-stimulating hormone (TSH) levels of 3.1 pmol/L, 9.9 pmol/L and, 8.9 mU/L. It was considered that hypothyroidism was induced by apatinib. Then apatinib was discontinued and levothyroxine sodium tablets 50 μg by mouth once daily was given. Ten days later, the patient′s symptoms relieved and the serum FT3, FT4, and TSH levels were 5.4 pmol/L, 15.8 pmol/L, and 5.7 mU/L. Then oral apatinib was given at a reduced dose of 500 mg once daily. Five days later, the patient developed fatigue again and then apatinib was stopped again. The patient′s symptoms relieved 10 days after the drug withdrawal and the serum FT3, FT4, and TSH levels returned to 4.9 pmol/L, 10.8 pmol/L, and 5.4 mU/L.
  • Shen Xintian, Zhou Ping, Liang Xiaoqin, Chen Yu, Zhong Ming, Fan Xiaomei, Guo Huijuan
    A male preterm infant, who was born at 28 weeks+2 of gestational age and diagnosed as preterm hyaline membrane disease (PHMD) 2 hours after birth, was given nasal continuous positive airway pressure (nCAPA) therapy, intratracheal instillation of poractant alfa injection, intravenous infusion of ceftazidime and penicillin for infection, and caffeine for stimulating respiration. On day 4 of treatment, the infant′s heart rate reached 160-170 beats/min. It was suspected that caffeine induced tachycardia, and the heart rate restored when caffeine was withdrawn. On day 16, the infant′s condition was improved significantly, nCAPA was changed to noninvasive positive pressure ventilation and caffeine was given again to stimulate respiration. On day 24, cimetidine was given due to bile reflux. On day 28, intravenous infusion of erythromycin was given because of positive Ureaplasma urealyticum DNA in sputum. On day 29, cimetidine was stopped. Since day 25 after treatment, the systolic pressure was higher than 83 mmHg for 9 continuous days and elevated to 106/75 mmHg on day 34. The severe hypertension was considered to be caused by caffeine. When caffeine was stopped, the blood pressure returned to normal. On day 46, the infant′s symptoms were improved significantly, high flow oxygen was given, erythromycin was stopped, and caffeine was added for the third time. Hypertension did not recur. The relationship between the hypertension and drugs was evaluated by Karch-Lasagna method, indicating that the hypertension was probably related to combined use of caffeine and cimetidine or erythromycin.
  • Shen Zhongxia, Zhang Xiaomei, Cai Min, Gen Song, Zhang Zhen, Yang Shengliang, Shen Xinhua
    ObjectiveTo explore the effects of escitalopram on coagulation function in depression patients.MethodsThis was a self-controlled prospective study. The subjects were depression patients (Hamilton Depression Scale (HAMD) score>17) who presented to or hospitalized in the Department of Psychosomatic Disorders in the Third People′s Hospital of Huzhou City from June 1, 2016 to June 1, 2017. The patients in accordance with inclusion criteria were treated with escitalopram (initial dose was 5 mg/d and increased to 10-20 mg/d within 2 weeks). HAMD rating scale were performed, prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and fibrinogen (FIB) were detected before treatment and 4 weeks after treatment. Response was defined as a  50% reduction in HAMD score.ResultsA total of 95 patients finished the 4 weeks treatment with escitalopram. Of them, 38 patients were male with ages from 21 to 64 years and mean age of (39±12) years, with illness duration from 14 to 60 months and mean illness duration of (32±12) years; 57 cases were female with ages from 20 to 64 years and mean age of (38±13) years, with illness duration from 12 to 54 and mean illness duration of (28±12) years. HAMD score were (21.8±3.4) and (9.1±3.3) before and after 4 weeks treatment, respectively (t=26.125, P<0.001). The levels of PT, APTT, and TT in patients after 4 weeks treatment were significantly higher than those before treatment [(11.14±1.22) s vs. (11.66±1.41) s, (29.45±5.24)s vs. (31.28±5.64) s, (20.32±2.08) s vs. (21.15±2.21) s, respectively, all P<0.05]. However, the FIB level after 4 weeks treatment was significantly decreased than that before treatment[(1.92±0.28) g/L vs. (2.01±0.34) g/L, P<0.05]. There were no significant differences among the indexes of coagulation function among the patients with different sex (P>0.05). After treatment, the increased values of PT and TT levels and the decreased value of FIB level in female patients were significantly higher than those in male patients (all P<0.05). After treatment, there were no significant differences in the increased value of PT, TT and APTT and the decreased value of FIB between the response group (80 cases) and the non-response group (15 cases) (all P>0.05). One 24-year-old female patient presented with upper gastrointestinal bleeding after more than 1 month of escitalopram treatment at a dose of 15 mg/d.ConclusionEscitalopram has an influence on coagulation function in depression patients, especially in female patients, which may increase the risk of bleeding.
  • Chen Tingting, Zhang Qingquan, Lin Zhiqiang
    Adverse Drug Reactions Journal. 2024, 26(8): 454-459. https://doi.org/10.3760/cma.j.cn114015‑20231124‑00842
    Objective To understand the occurrence of drug?drug interaction (DDI) in medical orders and the relevant common medications of hospitalized patients treated with voriconazole. Methods The treatment information of hospitalized patients treated with voriconazole and had blood trough concentration (Cmin) results in Quanzhou First Hospital, Fujian Province from May 2018 to August 2023 was collected through the hospital information system. Descriptive statistical analysis was conducted on the incidence of DDI medical orders, the drugs involved in DDI, the types and risk levels of DDI, the departments where DDI occurred, and the Cmin changes of voriconazole in patients with 1 or 2 type of voriconazole?related DDI medical orders (including drugs not recommended in combination with voriconazole or voriconazole dose needs to be adjusted when combined) during voriconazole treatment. Results A total of 752 patients were included, of which 592 (78.7%) had 1?344 medical orders with voriconazole?related DDI, involving 28 drugs. Among them, 67.7% (401/592) of patients used 2 or more DDI drugs. Glucocorticoids [91.6% (542/592)], followed by proton pump inhibitors [87.8% (520/592)], were most frequently involved in the medical orders of DDI with voriconazole. Among the 28 voriconazole?related DDI drugs, 5 were involved in type 1 or 2 DDI, including rifampicin, nirmatrelvir/ritonavir, phenobarbital, phenytoin sodium, and rifabutin. The 5 drugs involved 33 patients, of whom 51.5% (17 patients) had voriconazole Cmin<1.0?mg/L; rifampicin involved the most patients (17 patients), followed by nirmatrelvir/ritonavir (10 patients). When voriconazole was combined with rifampicin, rifabutin, phenobarbital and phenytoin sodium, its Cmin in most patients decreased significantly. The incidence of medical orders with voriconazole?related DDI was highest in the Intensive Care Unit, followed by the Department of Respiratory and Critical Care Medicine. Conclusions Medical orders with DDI are very common in the clinical application of voricona- zole, and most patients have used two or more DDI drugs, in which glucocorticoids and proton pump inhibitors appeared more common. It is necessary to be alert to the occurrence of DDI between voriconazole and rifampicin, rifabutin, phenobarbital and phenytoin  sodium in clinic.
  • Xing Xiaomin, Li Xiangpeng, Quan Xianghua, Wang Xinyi, Wang Wenxiao, Li Jing
    Adverse Drug Reactions Journal. 2024, 26(9): 551-556. https://doi.org/10.3760/cma.j.cn114015-20240110-00020
    Objective To establish a prescription pre⁃audit system based on the structureprocess⁃outcome (SPO) model in the the Affiliated Hospital of Qingdao University and explore its application effect. Methods Based on the structural dimension of SPO model, the organizational structure, pharmaceutical team, management system of pharmaceutical prescription audit, and audit environment of the prescription pre⁃audit system were established. Based on the process dimension of SPO model, the preaudit process, medication knowledge base, and audit rule base were established, quality monitoring and control were implemented, and relevant personnel training were conducted. Based on the outcome dimension of SPO model, the review rate, manual review rate, clinician acceptance rate of prescription review, reasonable rate of outpatient and emergency prescription comments, and intervention rate of inpatient medical order were verified after the prescription pre⁃audit system application. Results The prescription preaudit system was first launched in the main hospital area of the Affiliated Hospital of Qingdao University in March 2021, and achieved full coverage in all five hospital areas by May 2023. The review rates of outpatient and emergency prescriptions and inpatient medical orders had been increasing year by year from 2021 to 2023, and all reached more than 99% of the expected rates in 2023. Compared with 2021, the proportions of outpatient and emergency prescriptions and inpatient medical orders submitted to manual review decreased in 2023
    [1.2% (112 206/9 509 430) vs. 2.9% (16 214/549 672), 2.9% (206 258/7 152 620) vs. 3.9% (147 679/3 814 929), the proportions of prescriptions that failed to be reviewed in time decreased [0.7% (62 382/9 509 430) vs. 1.4% (7 429/549 672), 0.3% (22 816/7 152 620) vs. 2.2% (83 303/3 814 929)], and the acceptance rates of outpatient and emergency prescription review and inpatient medical orders review by clinicians increased [76.1% (2 421/3 180) vs. 57.0% (339/595), 94.3% (1 000/1 060) vs. 70.7% (797/1 128)],
    with statistically significant differences (all P<0.001). But there were still some prescriptions and orders that needed manual review but were not reviewed in time and finally missed review. Compared with 2021, the reasonable rates of outpatient and emergency prescription comments increased in 2023 [96.7% (924 558/956 252) vs. 92.2% (983 827/1 067 357), 98.7% (518 307/525 227) vs. 98.0% (181 296/185 069)], and the intervention rate of inpatient medical orders decreased [0.7% (196 522/26 751 992) vs. 0.9% (195 660/22 631 289)], with statistically significant differences (all P<0.001). Conclusions Applying the SPO model can improve the organization and management of the prescription pre⁃audit system, and ensure the smooth launch and safe operation of the system. After verification, the operating speed of the prescription pre⁃audit system and prescription review speed of pharmacists could basically meet the clinical needs, the indicators of rational drug use in the hospitals were improved, and the professional and technical ability of pharmacists were enhanced.
  • Guo Tiantian, Ma Zikun, Wang Yu, Wu Ting, Wang Yan, Li Kexin, Ou Xiaojuan, Jia Jidong, Zhao Xinyan
    Adverse Drug Reactions Journal. 2023, 25(6): 345-351. https://doi.org/10.3760/cma.j.cn114015-20220803-00710
    Objective To explore the clinical characteristics and prognosis of drug-induced liver injury (DILI) in elderly patients. Methods The clinical data (including demographic characteristics, clinical features and relevant laboratory tests, suspected pathogenic drugs, and prognosis of DILI, etc.) of patients hospitalized due to DILI from January 2009 to December 2020 were collected through the DILI Data- base in Liver Research Center of Beijing Friendship Hospital, Capital Medical University. The patients were divided into young group (<40 years old), middle-aged group (40-59 years old), and elderly group (≥ 60 years old) according to their ages. The demographic characteristics, clinical features, and prognosis of DILI were compared among the 3 groups. The risk factors for all-cause death/liver transplantation in DILI patients were analyzed using univariate and multivariate COX regression models. Results A total of 620 patients were entered in the study, including 477 females (76.9%) and 143 males (23.1%), with a median age of 56 (46, 64) years. There were 101 patients (16.3%) in the young group, 273 (44.0%) in the middle-aged group, and 246 (39.7%) in the elderly group, respectively. Compared with the young and middle-aged group respectively, patients in the elderly group had less fever [5.7% (14/246) vs. 18.8% (19/101) and 11.4% (31/273)], more abdominal distension [26.8% (66/246) vs. 11.9% (12/101) and 18.7% (51/273)], higher levels of alkaline phosphatase [171 (127, 265) U/L vs. 146 (104, 218) U/L and 158 (114, 221) U/L], gamma-glutamyltransferase [211 (132, 361) U/L vs. 122 (67, 200) U/L and 167 (94, 291) U/L], and serum creatinine [70 (59, 81) μmol/L vs. 58 (49, 72) μmol/L and 63 (57, 71) μmol/L], lower levels of serum albumin [36.2 (32.0, 38.8) g/L vs. 38.4 (35.2, 41.3) g/L and 37.3 (34.1, 40.7) g/L], immunoglobulin M [840 (610, 1190) mg/L vs. 1-030 (820, 1-460) mg/L and 1-060 (700, 1-480) mg/L], and platelet counts [186 (143, 236)×109/L vs. 214 (174, 270)×109/L and 210 (160, 257)×109/L], higher proportion of cholestasis type [13.0% (32/246) vs. 3.0% (3/101) and 5.5% (15/273)], lower rate of normalized liver function [80.5% (198/246) vs. 88.1% (89/101) and 89.0% (243/273)], and higher proportion of all-cause death/liver transplantation [5.7% (14/246) vs. 3.0% (3/101) and 1.5% (4/273)]. The differences above mentioned were statistically significant (all P<0.05). Multivariate COX regression analysis showed that age [hazard ratio (HR)=1.029, 95% confidence interval (CI): 1.002-1.056, P=0.034), serum albumin (HR=0.933, 95%CI: 0.883-0.985, P=0.012), cholesterol (HR=1.006, 95%CI: 1.004-1.008, P<0.001), serum creatinine (HR=1.007, 95%CI: 1.000-1.015, P=0.049), and severity of DILI (HR=2.328, 95%CI: 1.692-3.202, P<0.001) were independent influencing factors of all-cause death/liver transplantation in DILI patients. Conclusions Age, serum albumin, total cholesterol, serum creatinine, and severity of DILI are independent influencing factors for all-cause death/liver transplantation in DILI. Cholestatic liver injury is more common in elderly patients with DILI and the prognosis is poor, which needs more clinical attention.
  • 病例报告
    . 2004, 6(3): 179-180.
  • 不良事件
    . 2005, 7(2): 146-147.
  • 病例报告
    . 2001, 3(3): 195-196.
  • 病例报告
    . 2002, 4(1): 45-46.
  • Li Huibo, Zhao Zhe, Yang Canyu, Cheng Yinchu, Liu Fang, Zhu Yizhun, Lu Jie, Wei Yuan, Han Tongyan, Zhao Rongsheng
    Adverse Drug Reactions Journal. 2023, 25(11): 669-675. https://doi.org/10.3760/cma.j.cn114015-20230202-00050
    Objective To explore and establish a standardized clinical thinking mode and decision-making pathway for lactation medication consultation services and ensure the harmonization and safety of medication for lactating women. Methods Lactation medication consultation services for medical staffs conducted by pharmacists from June 2020 to August 2022 in Peking University Third Hospital were analyzed using methods of retrospective statistical analysis and root cause analysis. Application of mixed methods were used to establish a clinical thinking model for medication use during lactation and a clinical pathway for safe medication use during lactation. Lactation medication consultation service training for pharmacists was provided, questionnaire surveys before and after the training were conducted, and the effectiveness of improvement was evaluated. Results A total of 1-218 medication consultation services provided by clinical pharmacists to medical staffs were collected in the hospital, including 44 cases (3.61%) related to lactation medication. Retrospective analysis showed that clinical pharmacists did not have a clear understanding of patients′ needs, incomplete consideration of drug-maternal-infant factors, and a limited way to retrieve information in the lactation medication consultation service. Based on the root cause analysis of the problems, a clinical thinking mode of “Questions (Q), Assessment (A), Search (S), and Plan (P)" (QASP) were established. Additionally, a clinical pathway for safe medication decision-making analysis and a standard medication consultation  record template was developed. Compared with before training, clinical pharmacists made significant progress in clarifying factors related to lactation medication, evidence-based procedure, standardized documentation, and confidence in providing medication consulations (all P<0.001). Conclusion The establishment of the QASP clinical thinking model and decision analysis model, based on the 3 factors of medication, mother, and baby for the consultation service of safe medication during lactation, can help clinical pharmacists carry out standardized medication consultation services for breast-feeding  populations during lactation, and improve the quality of homogeneous pharmaceutical services.
  • Xu Lu, Wei Yuan, Lu Fuhui, Zhou Xingbei, Wu Jing
    Adverse Drug Reactions Journal. 2023, 25(12): 705-711. https://doi.org/10.3760/cma.j.cn114015-20230520-00378
    Objective To develop 2 prediction models for anti-tuberculosis drug-induced liver injury (ATB-DILI) based on convolutional neural network (CNN) and multiple logistic regression, and to evaluate and compare the performance of the 2 models. Methods The clinical and laboratory test data of inpatients in the Third People′s Hospital of Zhenjiang, Jurong People's Hospital, and the Third People′s Hospital of Danyang from January 1, 2019 to October 31, 2022 were collected. According to whether ATB-DILI occurred, patients were divided into with and without ATB-DILI groups, and the clinical characteristics of the 2 groups were compared. The patients were randomly divided into training set and test set according to a ratio of 7∶3 by random number table method. Based on data in the training set, multiple logistic regression and CNN were used to develop ATB-DILI prediction models; based on data in the training and test sets, the accuracy of the 2 models in predicting ATB-DILI was verified. The receiver operating characteristic (ROC) curve was drawn, and the sensitivity, specificity, Youden index and area under the curve (AUC) of the 2 models were compared. Results A total of 3-012 patients were included in the study, of which 294 (9.76%) were diagnosed with ATB-DILI; 2-108 patients were in the training set and 904 in the test set. The results of multiple logistic regression analysis showed that age, history of liver diseases, hypoalbuminemia, and no preventive use of liver protection drugs were independent risk factors for the occurrence of ATB-DILI. Based on these risk factors, multiple logistic regression model equations were constructed. The results of deep learning and analyzing the patient data of the training set by CNN showed that the top 5 risk factors that had the greatest impact on the occurrence of ATB-DILI were history of liver disease, age, no preventive use of liver protection drugs, hypoalbuminemia, and alcohol consumption. The CNN model was constructed according to the top 5 risk factors. The total accuracy in predicting the occurrence of ATB-DILI in the training and test sets using the multiple logistic regression model was 87.62% and 88.27%, respectively, and the total accuracy of using CNN model was 92.36% and 91.70%, respectively. The sensitivity, specificity, and AUC of the CNN model were all higher than those of the multiple logistic regression model, and the differences were statistically significant (all P<0.05). Conclusion Both the multiple logistic regression model and CNN model have good predictive performance for the occurrence of ATB-DILI, and the prediction performance of CNN model is better, comparatively.
  • Adverse Drug Reactions Journal. 2024, 26(8): 466-466. https://doi.org/10.1007/s40264⁃024⁃01421⁃9
    个例安全性报告数据库中报告的比例不相称分析是药物警戒检测安全信号常用的定量方法,其研究结果经常发表在专业药理学期刊和普通医学期刊上。然而报告比例不相称的信号,由于缺乏暴露数据、存在未量化的少报和选择性报告的偏倚,本身不能被解释为药物与不良事件之间因果关系的结论性科学证据。据统计,75%以上已发表的比例不相称的研究,未报告理解和重复所作研究的分析和结果所需的基本要素,2/3以上的作者过度或错误解释了他们的发现,尤其是在摘要中。而目前已有的指南,如“加强流行病学观察性研究报告(STROBE)”和“使用观察性常规收集的卫生数据开展药物流行病学研究报告规范(RECORD-PE)”等,都未能涵盖报告比例不相称分析研究的特殊性质。
    为此,该研究的作者(来自大学、制药企业和监管机构的34名国际专家组成的小组,在药物警戒、比例不相称分析和安全信号评估方面具有专业知识)制定了一个用于报告比例不相称分析结果的文章和摘要的指南—“药物警戒应用个例安全性报告检测药物安全信号的比例不相称分析的报告(READUS?PV)”,具体描述了制订过程及指南的内容。
    READUS?PV指南包括用于不相称分析研究报告的14项建议的检查清单,以及用于摘要的4个附加项目。通过指出在研究设计过程中的问题,减少错误解释结果的风险,该指南可以间接地提高研究质量。该指南使用对象定位于应用个例安全性报告数据库进行比例不相称分析的作者、接收相关稿件的编辑、同行审稿人和用户。预期该指南的落实将使得对比例不相称分析的报告和解释更加透明、全面和准确,可促进与其他证据来源的整合。

  • Liu Jiao, Zhang Xiongjian, Liu Yingxiong
    Adverse Drug Reactions Journal. 2024, 26(11): 700-702. https://doi.org/10.3760/cma.j.cn114015-20240228-00120
    A 66-year-old male patient administered diclofenac sodium 10 mg once daily for arthralgia by himself. After 3 days of medication, he developed oral bleeding and a platelet count (PLT) of 1×109/L. Considering that the patient had normal PLT previously and diclofenac sodium was used only for a short time, he was diagnosed with immune thrombocytopenia after a series of examinations including bone marrow aspiration and biopsy. Diclofenac sodium was discontinued, and the patient was treated with glucocorticoids, platelet transfusion, and hemostasis therapy. On the 7th day of treatments, the PLT increased to 164×109/L, and subsequent PLT re-examinations remained normal. Approximately 2 months later, the patient took diclofenac sodium for arthralgia again. After 2 days of medication, the PLT dropped to 8×109/L. Diclofenac sodium was discontinued, and the patient was treated with the previous therapeutic regimen, supplemented with recombinant human thrombopoietin and leucogen tablets. After 4 days of treatments, the PLT increased to 117×109/L. The patient′s reduction in PLT was considered to be caused by diclofenac sodium.
  • Zhou Ying, Jiang Guiping, Zhang Jinsong
    Adverse Drug Reactions Journal. 2024, 26(12): 711-714. https://doi.org/10.3760/cma.j.cn114015-20231204-00857
    Intravenous infusion has played an important role in emergency treatments in China, but there is also the phenomenon that emergency infusion is overused. The high burden of emergency infusion may cause more medication safety problems, such as adverse drug reactions, medication errors, drug interactions, and so on. The risks in emergency infusion should be paid high attention to. We should actively construct a comprehensive management model for the prevention and control of emergency infusion safety risks by strengthening multidisciplinary cooperation, avoid unnecessary intravenous infusion, and develop diagnostic criteria and treatment guidelines for adverse events in intravenous infusion, so as to better ensure the medication safety in emergency patients treated with intravenous infusion.
  • Zhao Zhenhuan, Li Lei, Liang Yu, Fu Lei, Jing Fanbo, Qu Haijun
    Adverse Drug Reactions Journal. 2021, 23(11): 607-608. https://doi.org/10.3760/cma.j.cn114015-20210524-00603
    A 57-year-old male patient with epilepsy was additionally given topiramate 25-mg orally once at night because of poor curative effect of sodium valproate. Seven days later, the patient developed vision loss with eye pain and swelling. Ocular ultrasonography showed bilateral choroidal detachment, which was considered to be related to topiramate. Topiramate was discontinued and prednisone acetate 60-mg once daily was given, and 8 days later, the patient′s eye pain and swelling were improved. Ocular ultrasonography showed that choroidal detachment disappeared. Fifteen days after drug withdrawal, his ocular symptoms disappeared.
  • Meng Yan, Cai Haodong
    Adverse Drug Reactions Journal. 2025, 27(5): 257-259. https://doi.org/10.3760/cma.j.cn114015‑20250311‑00133
    Adverse drug reaction (ADR) is an important problem in clinical diagnosis and treatment, and basic research related to ADR is essential. Exploring the mechanism of ADR through basic research can provide a theoretical basis for formulating effective prevention strategies and targeted treatment programs for ADR; many safety problems found in the process of clinical medication can be effectively verified and solved through basic research, such as the dose?response (toxicity) relationship of drugs and drug interactions; basic research related to drug toxicity is an indispensable key link in the process of drug research and development, and its research results are directly related to the safety of candidate compounds and the feasibility of clinical application. At present, there is a limited amount of literature on the basic research related to the mechanism of ADR in China. It is hoped that more researchers will pay attention to basic research related to ADR and drug safety, and promote the development of this field to a higher level.
  • 病例报告
    . 2006, 8(6): 453-454.
  • 安全信息
    . 2008, 10(4): 0-0.
  • 病例报告
    . 2002, 4(4): 261-262.
  • Fang Zhiyuan, Li Qian, Luo Jing, Lian Jiangping, Zhou Nan
    ObjectiveTo analysis the rationality of atorvastatin calcium and simvastatin in outpatient and emergency departments from the perspective of drug interactions.MethodsAll prescrip-tions comprising atorvastatin calcium and simvastatin in the outpatient and emergency departments in Shaanxi Provincial People′s Hospital from July 1 to December 31, 2017 were collected. The potential adverse drug interactions in these prescriptions were analyzed and the rationality of drug uses was determined by referring to the drug labels and relevant domestic and foreign guidelines.ResultsA total of 3 647 prescriptions in the outpatient and emergency departments were collected, of which 2 730 (74.9%) comprised atorvastatin calcium and 917 (25.1%) comprised simvastatin. Among the 3 647 prescriptions, 3 221 (88.3%)  comprised more than one drug, of which 2 432 (75.5%) comprised atorvastatin calcium and 789 (24.5%) comprised simvastatin. In the 3 221 co-prescriptions comprising statins, 878 (27.3%) comprised other substrates of cytochrome P450 (CYP) 3A4, mainly including adenosine diphosphate receptor inhibitors, calcium channel blockers, and proton pump inhibitors, of which clopidogrel and nifedipine were used more frequently; 311 (9.7%) comprised CYP 3A4 inhibitors, mainly including calcium channel blockers, anti-arrhythmia agents, immunosuppressive agents, and antibacterial drugs, of which amlodipine and diltiazem were used more frequently; 17 (0.5%) comprised CYP3A4 inductions, including pioglitazone and carbamazepine. Among the co-prescriptions of statins and CYP 3A4 inhibitors, 6 prescriptions comprised incompatibility drugs (simvastatin combined with clarithromycin) and 15 prescriptions comprised simvastatin or atorvastatin calcium with dose higher than the recommended.ConclusionDrug combination of atorvastatin calcium or simvastatin in some prescriptions of Shaanxi Provincial People′s Hospital is unreasonable, mainly shown as being combined with drugs having potential adverse interactions or overdosage when combined with CYP 3A4 inhibitors.
  • . 2015, 17(2): 83-83.
  • ADR咨询
    . 2006, 8(1): 74-74.
  • ADR咨询
    . 2003, 5(2): 136-136.
  • 安全信息
    . 2012, 14(3): 148-1.
  • Yang Wei, Tang Mingming, Suo Lixia
    A 47-year-old male patient with type-2 diabetes received metformin (1 g twice daily), acarbose (50 mg thrice daily), and pioglitazone (15 mg once daily) because of poor blood glucose control. On the 5th day of treatments, urinary incontinence appeared and the urine volume was about 200 ml. Pioglitazone was stopped and other treatments were continued. At 24 months of follow-up, urinary incontinence did not recur.
  • Gao Weina, Xie Yihong
    Adverse Drug Reactions Journal. 2020, 22(4): 264-265. https://doi.org/10.3760/cma.j.cn114015-20181221-01272
    Three Tibetan male patients (patient 1, 64-year-old; patient 2, 51-year-old; patient 3, 39-year-old) with previous history of gout received sodium phosphates oral solution 90-ml in intestinal preparation for endoscopic examination or treatment. The patients all developed typical gout attack on day 2 after their medications, but their blood uric acid levels were lower than those before taking the medicine (patient 1, from 526-μmol/L to 417-μmol/L; patient 2, from 566-μmol/L to 374-μmol/L; patient 3, from 465-μmol/L to 379-μmol/L), respectively. The acute attack of gout in the 3 patients was considered to be related with sodium phosphates oral solution, but whether it was related with phosphate crystallization was not determined.
  • 病例报告
    Shen Zetian;Wang Lifeng;Qian Xiaoping;Liu Baorui
    . 2008, 10(1): 0-0.

    A 61 yearold man with advanced gastric carcinoma received chemotherapy with IV docetaxel 40 mg/m2, IV calcium folinate 120 mg/m2, and fluorouracil 800 mg/m2 via a central vein for 24 hours, in combination with two cycles of intraperitoneal hydroxycamptothecin 15 mg and thermotherapy after the surgery. On day 5 after the chemotherapy, he developed progressive pitting oedema of the lower extremities. After 4 days of treatment with methylprednisolone and furosemide, his oedema resolved.

  • 安全信息
    . 2006, 8(4): 307-307.
  • Chen Yeqing, Zhou Hongyu, Yuan Shuai, Wang Zhenxiang
    Adverse Drug Reactions Journal. 2023, 25(8): 506-507. https://doi.org/10.3760/cma.j.cn114015-20220725-00673
    A 29-year-old male patient was treated with levofloxacin and other treatments for ulcerative colitis. Due to poor curative effect, he was given infliximab 300-mg intravenously, and his condition was stable after 3 times of medication. One month later, the patient developed mucinous bloody stool again, and enteroscopy showed ulcerative colitis (active phase). The patient received infliximab 300-mg intravenously once every 8 weeks and azathioprine 50-mg once daily orally. After 23 days of treatment, the patient developed persistent pain in the upper abdomen, serum amylase was 411-U/L, blood lipase was 1-415-U/L, and serum pancreatic amylase was 374-U/L. Abdominal CT showed acute pancreatitis, which was considered to be related to azathioprine. Seven days after discontinuation of azathioprine and treatment with fasting, acid suppression, anti-infection, and pancreatic secretion inhibition, his symptoms were relieved, and serum amylase and lipase levels returned to normal. One month later, the patient took azathioprine orally again according to the original dose by himself, and the symptoms of acute pancreatitis reappeared 6 hours later. The drug was stopped and the above treatments were given. Five days later, the patient′s symptoms were relieved, and the blood routine examination and serum amylase returned to normal.
  • Zhang Yejin, Liu Huayong, Xie Lixia
    Adverse Drug Reactions Journal. 2024, 26(3): 138-144. https://doi.org/10.3760/cma.j.cn114015-20230912-00677
    Objective To explore the clinical characteristics of interstitial lung disease (ILD) caused by furazolidone. Methods Clinical data of 7 patients with furazolidone-related ILD (hospital cases) hospitalized in the Department of Respiratory Medicine, Huazhong University of Science and Technology Union Shenzhen Hospital from April 1, 2022 to April 1, 2023 were collected and retrospectively analyzed, including patient basic information, medication treatments, and characteristics, treatment and outcomes of ILD. Relevant databases at home and abroad were searched, and case reports of furazolidone-related ILD (literature cases) were collected. The basic information of literature, involving patient information, indications and treatment doses of furazolidone, as well as the latentperiod, main symptoms, laboratory tests, and auxiliary examination related to ILD was descriptively analyzed. Results Among the 7 hospital cases, 2 were males and 5 were females, with a median age of 34 years. All patients were treated with a bismuth quadruple therapy containing furazolidone (0.2 g, once daily) due to Helicobacter pylori (HP)-associated gastritis. The median time from taking medicine to the onset of clinical symptoms of interstitial lung disease was 10 days. All patients had fever, and 6 had respiratory symptoms (dry cough, dyspnea, chest pain, etc.). ILD changes were found in all patients in their chest imaging, and pleural effusion was also found in 1 patient. Seven patients had normal eosinophil counts, and 1 had mild hypoxemia. The severity of ILD was grade 2 in 6 patients and grade 3 in 1 patient. All 7 patients stopped using furazolidone, and 4 received glucocorticoids additionally. After the hospitalization of 3-10 days, all the 7 patients recovered. Eighteen literature cases of furazolidone-related ILD were retrieved, of which 15 were from China and 14 used furazolidone to treat HP infection. The time from taking medicine to the onset of clinical symptoms was 2-14 days, and the time was >7 days in 13 patients. Sixteen patients had fever, 14-had respiratory symptoms, and 1 had respiratory failure. The peripheral blood eosinophil count or percentage increased in 12 patients. All 18 patients stopped using furazolidone; 7 received glucocorticoids and 1 received ventilator assisted ventilation. All patients recovered or were improved. ILD recured in rechallenge with furazolidone in 2 patients, and 1 of them had a strong positive reaction to furazolidone in vitro lymphocyte transformation test. Conclusions ILD is a rare adverse reaction of furazolidone, main manifests as fever and respiratory symptoms and mostly occurs 7 days after furazolidone treatment. Early detection and timely withdrawal of furazolidone generally lead to a good prognosis.
  • WHO信息
    . 2004, 6(5): 350-350.
  • SARS防治
    . 2003, 5(3): 148-149.
  • Xu Yan, Li Lin, Zhang Ping, Li Chao, Wang Hui
    . 2016, 18(6): 457.
    A 55-year-old female patient with breast cancer postoperation and lung, pleura and osseous metastasis received tegafur, gimeracil and oteracil potassium capsules  60 mg twice daily for 14 days. In the same period, the treatment for anticoagulation with warfarin (5.0 mg/d) for deep venous thrombosis  in left upper extremity were continued, and the drug dosage was not reduced. The patient′s international normalized ratio(INR)was 2.10 before taking the S-1 capsule. Six days after stopping tegafur, gimeracil and oteracil potassium capsules,  she developed  gross hematuria and the INR was increased to 9.47. The laboratory test showed the following results:  prothrombin time (PT) 117 s, plasma prothrombin activity (PTA) 6%, activated partial thromboplastin time (APTT)145 s,  and plasma fibrinogen (FIB) 4.1g/L. It was considered that the gross hematuria and elevation of INR were related to S-1 capsule combined with warfarin. Warfarin was stopped. The patient received an IV infusion of fresh frozen plasma  and an intramuscular injection of Vitamin K1. Twenty four hours after stopping  tegafur, gimeracil and oteracil potassium capsules, her INR declined to 5.81. Forty eight hours after stopping tegafur, gimeracil and oteracil potassium capsules, her INR was 1.04, PT 12 s, PTA 76%,  APTT 26 s, FIB 4.47 g/L, and the results of routine urine test returned to normal. She received subcutaneous injection with low molecular weight heparin  (0.4 ml/12 h) for 21 days because of subsequent chemotherapy with capecitabine. The results of  reexamination twenty days later,showed that the patient′s INR was 0.91 and no hematuria appeared.
  • 病例报告
    Liao Shumei;Nan Ling
    . 2011, 13(1): 49-1.
    A 71yearold man with knee osteoarthritis was given an intraarticular injection of sodium hyaluronate 20 mg in his right knee. The patient did not present with obvious discomfort after the first injection. Six days later, he received the second intraarticular injection of sodium hyaluronate 20 mg. About 5 hours after the second injection, he experienced chills, palpitation, and dyspnea. At the same time, his blood pressure was 96/60 mm Hg. He received oxygen inhalation therapy and symptomatic treatment. One hour later, his symptoms relieved and blood pressure was 105/70 mm Hg. During hospitalization, sodium hyaluronate was not given again and the abovementioned adverse reactions did not recur any more. He was discharged after two weeks of hospitalization.
  • ADR咨询
    . 2005, 7(3): 235-235.
  • WHO信息
    . 2004, 6(1): 62-62.
  • . 2015, 17(2): 93-94.
  • . 2015, 17(2): 88-90.
  • Shen Jianjun, Hu Zhigang, Zhang Hongyan
    . 2018, 20(1): 67.
    A 49-year-old male patient with recurrent nasopharyngeal carcinoma with multiple metastasis showed platelet count of 52×109/L on the second day after the end of the second cycle of chemotherapy. Recombinant human interleukin-11 was given 1.5 mg once daily by hypodermic injection. Four days later, the patient presented with systemic edema, hypoproteinemia, hydrothorax, peritoneal effusion and hypoproteinemia (total protein 57 g/L, albumin 33 g/L). Blood pressure declined to 95/67 mmHg (1 mmHg=0.133 kPa). The capillary leak syndrome was diagnosed. It was considered to be related to recombinant human interleukin-11. Interleukin-11 was stopped, 5 g of human serum albumin and 10 mg of dexamethasone were given intravenously once a day, and 0.15 g of asecuven forte was given orally twice a day. Meanwhile, best support therapy was given. Six days later, the edema disappeared and all the parameters gradually returned to normal.
  • Zhao Yi, Huang Xu, Liao Qiuju, Tian Zhen, Li Xuemei, Li Xiaoxia
    A 25-year-old woman with rheumatoid arthritis was treated with prednisone, leflunomide, hydroxychloroquine, and calcium carbonate vitamin D. Her condition was controlled well. Because of her fertility requirement, the therapeutic regimen was changed to sulfasalazine 1.0 g and hydroxychloroquine 0.2 g twice daily orally. About 2 months later, the patient developed fever, sore throat, swelling of bilateral tonsils (degreeⅡ) with purulent exudates on the surface, and bilateral cervical lymph nodes swelling. Laboratory tests showed white blood cell count 0.6×109/L and neutrophil count 0.01×109/L. The patient was diagnosed as having agranulocytosis induced by sulfasalazine accompanied by acute suppurative tonsillitis. Sulfasalazine and hydroxychloroquine were stopped and subcutaneous injection of recombinant human granulocyte colony stimulating factor 150 μg once daily were given for 6 consecutive days. Meanwhile, anti-infectious and symptomatic support treatments were given. Three weeks later, her white blood cell count and neutrophil count were returned to normal, and the clinical symptoms disappeared. Hydroxychloroquine and calcium carbonate vitamin D were given again. At 6 months of follow-up, the blood routine test results were normal and the condition of rheumatoid arthritis was stable.
  • Gong Rui, Liu Hong
    A 71-year-old male patient received sodium bicarbonate 1.0 g and colchicine 0.5 mg orally thrice daily, and benzbromarone 50 mg orally once daily for hyperuricemia with left ankle joint pain. On the first day, the patient took sodium bicarbonate and colchicine about 1 hour after dinner and developed palpable sense of hungry, accompanied with palpitations, vertigo, fatigue, and watery stool about 1 hour after the medication. The above symptoms relieved after having a small amount of porridge. On the second day, the above symptoms appeared after each dose and could relieve after eating a little food. On the third morning, the patient was found coma by a family member and admitted to hospital emergency department. On account of the random fingertip capillary and fasting venous blood glucose of 1.0 mmol/L and 1.8 mmol/L, the patient was immediately given 40 ml of 50% glucose injection intravenously, followed by intravenous infusion of a mixture, which contained 20 ml of 50% glucose injection and 500 ml of 10% glucose injection. Five minutes after the intravenous injection, the patient began to regain consciousness. Nine minutes after the intravenous injection, the patient′s consciousness was fully recovered and he could answer questions correctly. On day 2 after the hospitalization, the patient′s blood glucose level returned to normal and he had no discomfort symptoms. The patient continued to take benzbromarone and sodium bicarbonate after discharge and did not have hypoglycemia at 1 year of follow-up.
  • Song Zaiwei1,2,3, Huang Zhencheng, Zhang Enyao, Liu Shuang, Tan Zhiyuan, Zhao Rongsheng
    Adverse Drug Reactions Journal. 2019, 21(3): 183-189. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.005
    ObjectiveTo evaluate the association between blood methotrexate concentrations at 24 hours (C24 h) after the initiation of high-dose methotrexate (HDMTX) infusion and clinical outcomes in patients with hematologic neoplasm.MethodsThe literature on C24 h after the initiation of HDMTX treatment and clinical outcomes in MEDLINE (Ovid), EMBASE (Ovid), Clinical Trials. gov, CNKI, WanFang Data, and SinoMed databases up to March 2018 were retrieved (the outcome indicators mainly included safety indicators, such as adverse event incidence and effectiveness indicators, such as complete remission rate). The quality of the enrolled literature was evaluated by Newcastle-Ottawa Scale (NOS) and related outcome indicators were analyzed by meta-analysis or descriptive analysis.ResultsA total of 6 studies were enrolled, including 4 with high quality (NOS scores were 7-9) and 2 with medium quality (both of NOS scores were 6). All the subjects in the 6 studies were children with acute lymphoblastic leukemia (ALL), aged 0.4 to 17.0 years, and a total of 516 HDMTX treatments were given to them. Five studies reported the association between methotrexate C24 h and safety outcomes and 1 reported the association between methotrexate C24 h and effectiveness outcomes. For safety outcomes, compared with C24 h<10 μmol/L, methotrexate C24 h>10 μmol/L might increase the risk of hematological toxicity (OR=4.17, 95%CI: 1.17-14.90) rather than the risks of gastrointestinal toxicity (OR=2.22, 95%CI: 0.97-5.04), renal toxicity (P=0.130), oral mucositis (P=0.166), or dermal toxicity (P=0.227). Compared with C24 h <40 μmol/L, methotrexate C24 h>40 μmol/L might increase the risks of hepatotoxicity (OR=16.64, 95%CI: 6.35-43.64), oral mucositis (OR=31.73, 95%CI: 12.37-81.41), severe oral mucositis (P=0.002), and gastrointestinal toxicity (P=0.003). For effectiveness outcomes, the single study suggested that methotrexate C24 h>16 μmol/L could increase the complete and partial remission rates (P<0.05 for both) and decrease the 1.5 year-recurrence rate (P=0.006).ConclusionsThere was a significant association between methotrexate C24 h and clinical outcomes in children with ALL. Methotrexate C24 h>16 μmol/L was significantly associated with a favorable clinical outcome while C24 h>40 μmol/L was significantly associated with increased risks of hepatotoxicity, oral mucositis, and gastrointestinal toxicity.
  • 不良事件
    . 2003, 5(4): 270-271.
  • 病例报告
    . 2006, 8(4): 297-298.
  • 病例报告
    Zou Gongmin;Li Liping;Zhang Xuefeng
    . 2008, 10(1): 0-0.

    A 58yearold man who had a history of cholelithiasis, renal lithiasis, prostatic hypertrophy, type 2 diabetes mellitus, and hypertension was prescribed with ceftriaxone (dosage not stated) for management of cholecystitis. After 3 days of treatment, he presented with generalized erythema morbilliforme and oedema of the eyelids and lower extremities. On day 12, an urine routine test showed the following values: RBC (++) to(+++),PRO (+++). After admission, the renal function tests revealed the following levels: BUN 43.20 mmol/L, Cr 1 268.0 μmol/L, and UA 855 μmol/L. The patient was diagnosed with acute interstitial nephritis and acute renal failure. Combination therapy with haemodialysis, antiinfection, corticosteroid, diuretics, and fluid replacement was administered. One month later, erythema and oedema disappeared completely, and all biochemical values returned to normal ranges.

  • 病例报告
    . 2002, 4(2): 124-125.
  • Zhao Hongting, Ling Juan, Cheng Xiaoqiong, Xie Zhuolin, Zhang Dongpeng, Zhuo Jun
    Adverse Drug Reactions Journal. 2024, 26(5): 291-298. https://doi.org/10.3760/cma.j.cn114015-20231120-00823
    Objective To systematically evaluate the risk of hypotension induced by sodium- glucose transporter 2 (SGLT2) inhibitors in patients with type 2 diabetes mellitus. Methods Randomized controlled trials of SGLT2 inhibitors in the treatment of type 2 diabetes mellitus, in which hypotension were evaluated as an outcome indicator of adverse events, were collected by searching relevant databases at home and abroad (up to February 15, 2023). Cochrane risk of bias assessment tool was used to evaluate the quality of the included studies. Stata 15.1-software was used to conduct Bayesian network meta-analysis, including drawing the network evidence plot, the league map of pairwise comparison, and the surface under the cumulative ranking curve (SUCRA) for hypotension risk under different interventions of SGLT2 inhibitors, and ranking the risks of hypotension induced by different interventions of SGLT2 inhibitors. The effect sizes were expressed by relative risk (RR) and its 95% confidence interval (CI). Results A total of 20-studies were included in the analysis, involving 22-525 patients with 15-260 in the trial group and 7-265 in the control group. Drugs that used in the trial group included dapagliflozin (in 1-517 patients), canagliflozin (in 6-053 patients), and ertugliflozin (in 7-690 patients); drugs that used in the control group included glimepiride (in 482 patients) and placebo (in 6-783 patients). The results of the network meta-analysis showed that the risk of hypotension was higher after treatment with 300-mg of canagliflozin, compared with those with 5-mg and 15-mg of ertugliflozin, and placebo (RR=2.13, 95%CI: 1.31-3.47; RR=2.21, 95%CI: 1.35-3.61; RR=2.49, 95%CI: 1.62-3.82; all P<0.05); the risk of hypotension was higher after treatment with 100-mg of canagliflozin, compared with placebo (RR=1.61,95%CI:1.04-2.50,P<0.05); the differences in comparison between any other 2 interventions with SGLT2 inhibitors were not statistically significant. According to the relative risks for hypotension of different interventions with SGLT2 inhibitors in the results of SUCRA, interventions were ranked as ertugliflozin 5-mg, placebo, dapagliflozin 2.5-mg, ertugliflozin 10-mg, ertugliflozin 15-mg, canagliflozin 50-mg, canagliflozin 100-mg, dapagliflozin 5-mg, dapagliflozin 10-mg, canagliflozin 150-mg, and canagliflozin 300-mg. Conclusions Different treatment regimens with SGLT2 inhibitors had different risks of hypotension in patients with type 2 diabetes. The risk of hypotension caused by ertugliflozin is lower, especially at the dose of 5-mg. The risk of hypotension caused by canagliflozin is higher, especially at relatively high doses.
  • Tang Haochun, Meng Jun
    Adverse Drug Reactions Journal. 2023, 25(4): 193-196. https://doi.org/10.3760/cma.j.cn114015-20230323-00220
    With the widespread use of immune checkpoint inhibitors (ICIs) in cancer therapy, immune-related adverse events (irAEs) are receiving increasing attention. Among them, ICI-related pneumonitis (CIP) is more common. This article introduces the clinical features, disease classification, and treatment strategies, etc. of CIP, and suggests multidisciplinary cooperation to carried out whole-process management for patients receiving ICIs treatment, early detection, early diagnosis, and establish clear and effective prevention and early warning strategies to maximize the benefits of cancer patients.
  • Rao Zhifang, Tu Jing, Cheng Zhenling
    Adverse Drug Reactions Journal. 2023, 25(11): 676-682. https://doi.org/10.3760/cma.j.cn114015-20230110-00003
    Objective To compare the risk for pneumonia in antiplatelet therapy with clopidogrel and ticagrelor. Methods The relevant databases including PubMed, Embase, Cochrane Library, CBM, CNKI, and Wanfang Med (up to March 1, 2022) were searched. The randomized controlled trials (RCTs) of clopidogrel and ticagrelor (trial group or control group to each other) in the treatment of coronary atherosclerotic heart disease were collected. The Cochrane collaboration risk of bias assessment tool was used to evaluate the methodological quality of the RCTs. RevMan 5.4 software was used for meta-analysis to compare the risk of pneumonia in patients between 2 groups. The effect sizes were the risk ratio (RR) and its 95% confidence interval (CI). Results A total of 5 RCTs were enrolled in the analysis. The methodological quality evaluation results showed that 2 RCTs were with low risk of bias and the others were high. In the 5 RCTs, 36 401 patients were involved, of which 18 724 received the therapy for acute coronary syndrome, 13-842 for peripheral artery disease, 3-799 for myocardial infarct, and 36 for coma survivor with cardiac arrest. The meta-analysis results showed that the incidence of pneumonia were 1.5%(271/18-174) and 1.2%(217/18-227) in patients receiving clopidogrel and ticagrelor, respectively; the risk of pneumonia in ticagrelor-treated patients was relatively lower, and the difference was statistically significant (RR=0.80, 95%CI: 0.67-0.95, P=0.01). Subgroup analysis showed that the risk for pneumonia was similar in patients between the 2 groups when they received short-term (several days) medication (P=0.26), while the risk was relatively lower in ticagrelor-treated patients compared with that in clopidogrel-treated patients when the therapeutical time was more than 12 months (RR=0.80, 95%CI: 0.67-0.96, P=0.02). And also, in the combination therapy with aspirin, the risk of pneumonia was lower in ticagrelor-treated patients than that in clopidogrel-treated patients (RR=0.74, 95%CI: 0.56-0.98, P=0.03). Conclusion Compared with clopidogrel, the risk for pneumonia was relatively lower in ticagrelor treatment than that in clopidogrel treatment.
  • Yan Li, Liu Jianying, Pan Wen
    Adverse Drug Reactions Journal. 2024, 26(6): 376-379. https://doi.org/10.3760/cma.j.cn114015-20230814-00597
    A 67-year-old male patient received long-term use of benidipine (8 mg once daily orally) and allisartan isoproxil (240-mg once daily orally) due to hypertension. Her blood pressure was controlled at around 150/80-mmHg. Due to the novel coronavirus infection, he experienced syncope, decreased blood pressure and unclear consciousness after self-administration of 3 doses of nirmatrelvir 300-mg/ritonavir 100-mg (Paxlovid). Continuous intravenous infusion of dopamine 200-mg/d was given. Two hours later, his blood pressure was 103/46-mmHg, heart rate was 50 beats/min, and blood oxygen saturation was 0.92; electrocardiogram showed sinus bradycardia (45 beats/min), and complete right bundle branch block. Antihypertensive medications were discontinued, his blood pressure gradually increased to 116/82, and dopamine was discontinued. After 5 days of antihypertention drug withdrawal, the patient′s blood pressure was 169/93-mmHg and antihypertensive drug treatment was gradually resumed, 8 days later, the patient′s blood pressure was 130/78-mmHg. The possibility of neurogenic, cardiogenic, and reflexive syncope were excluded through physical examination, long-term electroencephalography, virus antibody testing, head magnetic resonance imaging, electrocardiogram, myocardial enzyme testing, and other related tests. The occurrence and recovery time of hypotension syncope in the patient were consistent with the inhibition and recovery time of cytochrome P450 (CYP) 3A4 by ritonavir. Benidipine was mainly metabolized through CYP3A4 in the liver. Therefore, it was considered that the hypotension syncope in the patient was related to the enhanced antihypertensive effect of benidipine by ritonavir.
  • 病例报告
    . 2000, 2(2): 128-129.
  • 临床观察
    Liu Min;Li Li;Wang Ling;Cai Haodong
    . 2008, 10(1): 0-0.

    Objective:To observe the efficacy and safety of telbivudine for preventing mothertoinfant HBV vertical transmission in five HBVinfected pregnant women.Methods: From March to August 2007, 5 chronic HBVinfected women with a high risk for infecting their newborn infants by vertical transmission entered the study. Their HBV DNA levels were ≥1×107 copies/ml. The women were treated with oral telbivudine 600 mg once daily between 28 weeks after pregnancy and 1 month after labour. The changes in the HBV DNA level, liver function, and adverse reactions were observed in the five women. The neonates’ HBV DNA and HBsAg levels were measured. The neonates’developmental status was observed and Apgar scores were performed.Results: Of the 5 pregnant women, 4 pregnant women’s HBV DNA levels were not detected (<5×102 copies/ml). One pregnant woman’s HBV DNA level was 4.56×103 copies/ml. The five neonates were normally developed, and Apgar score was 10. The neonates’HBV DHA levels were <5×102 copies/ml, and their HBsAg tests were negative. Conclusion: Telbivudine seems to be effective in the preventing of mothertoinfant HBV vertical transmission and no influence on infant’s development.

  • Pan Chen, Ren Yue, Shen Su
    Adverse Drug Reactions Journal. 2019, 21(2): 129-134. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.011
    Contrast-induced acute kidney injury (CI-AKI) is a serious complication of coronary angiography (CAG) and percutaneous coronary intervention (PCI). Four risk assessment models of CI-AKI are introduced here, including Mehran CI-AKI risk assessment system, Chen CI-AKI risk assessment system, Maioli CI-AKI risk assessment system, and Duan CI-AKI risk assessment system. The predictive factors involved in the 4 models include hypotension, intra-aortic balloon pump, congestive heart-failure, advanced age, anemia, diabetes mellitus, volume of contrast, renal function, myocardial infarction, left ventricular ejection fraction, high density lipoprotein, emergency PCI, PCI or CAG procedure performed within the past 72 h, primary PCI, N-terminal pro-B-type natriuretic peptide, and high-sensitivity C-reactive protein. Mehran CI-AKI risk assessment system is used postoperatively, while the other 3 models are used preoperatively. Mehran CI-AKI risk assessment system is more influential at present. And there are already some reports on its external validation and promotion. Maioli CI-AKI risk assessment system has predictive value for patients with renal injury, additionally. The Chen CI-AKI risk assessment system is applied to the patients in Asian population. Duan CI-AKI risk assessment system incorporates 2 highly sensitive biomarkers of CI-AKI, N-terminal pro-B-type natriuretic peptide and high-sensitivity C-reactive protein. All of the above 4 models have certain limitations, and they all have no clinical practical evidences.
  • Fan Limei, Ruan Shishuang
    A 70-year-old male patient with chronic obstructive pulmonary disease received compound phenytoin sodium, ephedrin hydrochloride and theophylline tablets(each tablet containing phenytoin sodium 50 mg, chlorpheniramine maleate 1 mg, ephedrine hydrochloride 5 mg, caffeine 7.5 mg, theobromine 12.5 mg, theophylline 12.5 mg, belladonna flow extract 0.009 ml)  3 tablets thrice daily by mouth. Gait instability and clumsiness of his lower limbs appeared after 29 months of medication and gradually worsened with mental disorders (such as sparoxysmal unconsciousness, increased daytime sleep and balderdash) after 35 months of medication. Laboratory tests showed that the blood phenytoin concentration was 30 mg/L. Phenytoin poisoning was considered. Compound phenytoin sodium, ephedrin hydrochloride and theophylline tablets were stopped, and symptomatic and supportive treatments were given. Ten days later, the patient became conscious, his mental disorders disappeared, and the blood phenytoin concentration decreased to be 15 mg/L. Fourteen days later, he could walk independently.
  • Quan Hui, Jiang Yuyong, Yu Hao, Hou Yixin
    Adverse Drug Reactions Journal. 2021, 23(2): 95-98. https://doi.org/10.3760/cma.j.cn114015-20201119-01152
    Three patients (patient 1, a 27-years-old male with chronic hepatitis C; patient 2, a 71-years-old male with hepatitis C complicated by hepatocellular carcinoma; patient 3, a 60-years-old male with hepatitis C decompensated cirrhosis) were treated with daclatasvir-based regimens and developed drug resistance or treatment failure. Patient 1 and patient 2 received daclatasvir combined with asunaprevir. No resistance variants in the non-structural protein (NS) 5A region of HCV were detected in the 2 patients before treatment. In patient 1, HCV RNA levels were both <15 IU/ml at 4 weeks of treatment and when the drug was stopped at 24 weeks of treatment. Ten days after the drug withdrawal, virological breakthrough occurred and HCV sequence analysis showed variants at 4 sites, including S122G, L31V, Y93H, and C316N. In patient 2, HCV RNA was <15 IU/ml at 8 weeks of treatment and virological breakthrough occurred at 12 weeks of treatment. Both patients were given sofosbuvir/velpatasvir combined with ribavirin for 12 weeks and achieved sustained virologic response (SVR). Patient 3 received sofosbuvir combined with daclatasvir for 24 weeks. His HCV RNA levels were all <15 IU/ml at 4 and 12 weeks of treatment and when the drugs were stopped at 24 weeks of treatment. Virological breakthrough appeared at 12 weeks of drug withdrawal. Sofosbuvir/velpatasvir combined with ribavirin were given for 24 weeks and SVR was achieved.
  • Liang Kuo, Li Jia, Liu Dongbin, Fang Yu, Sun Changyi, Li Fei
    . 2016, 18(5): 367.
    A 64-year-old male patient received clozapine 125 mg twice daily for 6 years because of paranoid schizophrenia. The dose of clozapine was increased to 250 mg twice daily by doctor due to his symptoms occurred repeatedly. About one month after increase of drug dosage, the patient developed abdominal pain, distention, nausea, vomiting, and oliguria. Then the drug was stopped by the patient. Two days after the drug withdrawal, the patient visited emergency department in our hospital. Physical examination showed that the patient had abdominal swelling, abdomen tenderness, hypoactive bowel sounds. Laboratory tests showed serum creatinine (Scr) 106 μmol/L, blood urea nitrogen (BUN) 11.2 mmol/L. Abdominal X-ray showed dilatation of the small intestine with multiple ladder-like fluid level. Paralytic ileus was considered. Fasting, fluid supplement,  anti-inflammatory, and gastrointestinal decompression were given. The next day, the renal function deteriorated, Scr and BUN levels were 606 μmol/L and 27.2 mmol/L, respectively; and his clozapine plasma concentration was 630 μg/L. Then it was considered that paralytic ileus combined with acute renal insufficiency was induced by clozapine. The patient was admitted to hospital and symptomatic treatments were given continuously. On day 3 after admission, the patient′s urine volume increased markedly. On day 5 after admission, abdominal pain and distention disappeared and day 8, his renal function returned to normal.
  • Xu Yan, Li Yan, Yang Qiuhong
    Adverse Drug Reactions Journal. 2021, 23(5): 275-276. https://doi.org/10.3760/cma.j.cn114015-20201125-01176
    A 31-year-old pregnant woman received an IV infusion of cefathiamidine 2 g dissolved in 0.9% sodium chloride injection 100-ml twice daily for prevention of infection during the perioperative period of cesarean section. Her platelet count (PLT) before medication was 166×109/L. Routine blood cell tests after the 2nd medication (21-h after operation) showed PLT 40×109/L. At 30-hours after the operation, the PLT decreased to the lowest level (14×109/L) and no bleeding symptoms occurred. Cefathiamidine was stopped, symptomatic and supportive treatments such as platelet supplement and intravenous infusions of immunoglobulin and methylprednisolone sodium succinate for injection were given. Four days later, her PLT returned to normal. The patient was followed up for 3 months postnatally, and the platelet level was normal.
  • Wang Yingkai, Cui Xiangli, Hou Kelu,Ma Zhuo,Wang Ying, Wang Xin
    Adverse Drug Reactions Journal. 2019, 21(6): 414-419. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.003
    ObjectiveTo explore the clinical characteristics, treatment and  prognosis of heparin-induced thrombocytopenia (HIT) in patients with pulmonary embolism after using unfractionated heparin (UFH) or low molecular weight heparin (LMWH).MethodsThe medical records of patients with pulmonary embolism, who were diagnosed between January 1, 2014 and September 30, 2018, and HIT after using UFH and LMWH were collected, which were searched from the Electronic Medical Record System in Beijing Chao-Yang Hospital, Capital Medical University. The improved pretest clinical scoring system (the 4 T′s score) was used to evaluate the possibility of HIT occurrence in patients. For the patients with HIT, the use of heparins, combined medication, the platelet count (PLT) before heparins use, the time from the beginning of heparin use to the onset of PLT decline, the lowest PLT, HIT specific antibody(HIT-Ab), as well as the treatment and outcome were further analyzed retrospectively.ResultsA total of 57 patients with thrombocytopenia after heparin treatment were collected, in which 11 (19.3%) were judged to be HIT using the 4 T′s score. Of the 11 patients, 6 were male and 5 were female, aged 27-87 years; 9 patients were given LMWH subcutaneously and 2 patients were given UFH by continuous intravenous pumping; the PLT decreased by (97±59)×109/L with the range of (30-233)×109/L after 2-10 days of heparin treatments (with an average of 7 days); 2 developed new pulmonary embolism and 1 developed multiple cerebral infarction; 2 patients underwent HIT-Ab test and they both had positive results. After the decrease of PLT, 1 of the 11 patients who continued to use heparin and infused fresh plasma had multiple organ failure and died of critical illness, other 10 patients stopped using heparin drugs immediately. Among the 10 patients, 8 switched to non-heparin anticoagulants and no thrombocytopenia occurred again; 2 stopped anticoagulation therapy, of which 1 died and 1 had unknown prognosis after hospital transfer.ConclusionsHIT in patients with pulmonary embolism mostly occurred about 1 week after heparin treatment. The HIT-Ab test may be positive and new thrombosis may occur in a few patients. The effect of HIT treatment is good when heparin was discontinued and replaced with non-heparin anticoagulants. The prognosis of patients who continue to use heparin or stop anticoagulation is poor.
  • 安全信息
    . 2007, 9(5): 380-380.
  • 病例报告
    Yu Junling;Feng Aiqiao;Zhang Yujuan
    . 2011, 13(1): 60-2.
    A 35yearold male patient with chronic hepatitis C received IM peginterferon alfa-2b 2 million units once weekly. Four months later, the patient experienced auditory hallucination, delusion, and mild personality changes. Subsequently, his symptoms gradually aggravated. One week later, he presented with delusion of persecution, thought incoherence, emotion discord, irritability, and insight disorder. Peginterferon alfa-2b was withdrawn, and he received symptomatic treatment with olanzapine. One week after therapy, his symptoms improved and, two weeks after therapy, he was discharged, and continued taking olanzapine for one week, and then the drug was stopped by himself. The above-mentioned psychiatric symptoms did not recur during a half year of follow-up.
  • 病例报告
    . 2003, 5(3): 150-150.
  • 国外信息
    . 2005, 7(1): 73-73.
  • Zhu Hui, Yuan Yongfang, Xu Ying
    Adverse Drug Reactions Journal. 2024, 26(1): 18-24. https://doi.org/10.3760/cma.j.cn114015-20230803-00582
    Objective To explore the occurrence, influencing factors, and predictive biomarkers of immune-related adverse events (irAEs) in malignant tumor patients treated with tislelizumab. Methods The electronic medical records of adult patients with malignant tumors, who received tislelizumab for at least one cycle from June 2020 to June 2023 at Shanghai Ninth People′s Hospital, Shanghai Jiao Tong University School of Medicine, were collected, and the occurrence and clinical characteristics of irAEs were retrospectively analyzed. Patients were divided into irAEs group and non-irAEs group according to whether they had irAEs. The clinical characteristics and detection value of biomarkers in patients of the 2 groups were compared. Multivariate logistic regression was used to analyze the risk factors of irAEs in patients. The receiver operating characteristic (ROC) curve was used to find the cutoff point of the biomarkers for predicting the irAEs. Results A total of 107 patients were entered, including 81 males (75.7%) and 26 females (24.3%), aged (61±15) years. Among them, 25 patients (23.4%) were diagnosed with tislelizumab-related irAEs, of which 6 patients (5.6%) had irAEs with a severity of grade 3 and above. A total of 28 irAEs occurred in the 25 patients, including 9 cases of thyroid dysfunction, 4 cases of immune-related enteritis, 4 cases of rashes, 3 cases of immune-related pneumonitis, 3 cases of kidney injury, 3 cases of liver injury, 1 case of immune- related myositis, and 1 case of hypertension. The median treatment cycle from the start of tislelizumab to the occurrence of irAEs was 3 (1, 5) cycles. After discontinuation of tislelizumab and/or glucocorticoids and symptomatic treatments, all 25 patients were improved. No deaths occurred due to irAEs. The results of multivariate logistic regression analysis showed that a high neutrophil-to-lymphocyte ratio (NLP) at baseline was a protective factor for irAEs [odds ratio (OR)=0.453, 95% confidence interval (CI): 0.279-0.735, P=0.001], while a high platelet-to-lymphocyte ratio (PLR) at baseline was a risk factor (OR=1.006, 95%CI: 1.002- 1.011, P=0.008). The ROC curve analysis results showed that the cutoff points of NLR and PLR at baseline for predicting the occurrence of irAEs were 1.58 (sensitivity: 0.988; specificity: 0.644) and 159.40 (sensitivity: 0.800; specificity: 0.524), respectively. Conclusions The incidence of irAEs in the tislelizumab treatment for adult malignant tumors was 23.4%. Thyroid dysfunction is most common and attentions should also be paid to immune-related enteritis, rashes, immune-related pneumonitis, kidney injury, and liver injury. Baseline levels of NLR and PLR may be biomarkers for predicting irAEs.
  • Cui Liqiang, Guo Daihong, Zhu Man, Wang Tianlin, Gao Ao, Zhao Anqi, Fu An, Xiao Jing
    Adverse Drug Reactions Journal. 2025, 27(2): 84-90. https://doi.org/10.3760/cma.j.cn114015-20240618-00416
    Objective Based on the adverse drug event active surveillance and assessment system-Ⅱ (ADE-ASAS-Ⅱ) and the information of inpatients in the hospital information system (HIS), the automatic monitoring module of movement disorders was constructed and its application effect in the real- world study of drug-induced movement disorders (DIMDs) was explored. Methods Literature reviews, case reports, spontaneous reports and medical records were collected, the keyword set was screened based on ADE-ASAS-Ⅱ system and text classification technology, and an automatic monitoring module was constructed. The information of hospitalized patients in Chinese PLA General Hospital (our hospital) was selected from October 10 to 16, 2022. The results of manual evaluation and the system alarm by the automatic monitoring module were compared, and the performance of the automatic monitoring module was evaluated and optimized through repeated machine learning. The medical record information of hospitalized patients who used sodium valproate throughout the year in our hospital in 2022 were collected, and the occurrence of movement disorders related to sodium valproate was analyzed using the automatic monitoring module. Results A total of 4 918 hospitalized patients (146 with movement disorders) were collected, and the final setting conditions of the automatic monitoring module were determined, including inclusion criteria (43 text keywords, 3 diagnosis) and exclusion criteria (11 text and 20 document titles were omitted). Among the 1 138 hospitalized patients using sodium valproate in 2022, the incidence of DIMDs with tic and tremor as main clinical manifestations detected by automatic monitoring module was 1.67% (19/1 138). Conclusion The automatic monitoring module of druginduced movement disorders based on machine learning and manual evaluation can be applied to explore the occurrence characteristics of DIMDs in the real world, and provide information for pharmacovigilance in clinic.
  • 病例报告
    . 2005, 7(4): 296-297.
  • 病例报告
    . 2006, 8(2): 130-131.
  • 药源性疾病
    Zhang Xiaoshua;Yu Aiheb
    . 2008, 10(1): 0-0.

    Reversible posterior leukoencephalopathy syndrome (RPLS) is a group of signs and symptoms mainly associated with posterior cerebral white matter lesions. It is characterized clinically by headache, visual disturbances, confusion, altered mental status, motion disturbances, and seizures. The characteristic abnormalities on neuroimges are often seen in the white matter of parietaltemporaloccipital lobes, as a lowdensity change on CT and as a high signal change on T2 weighted and ADC. The occurrence of RPLS is usually associated with hypertension, renal failure, and medications. The drugs that may induce RPLS are antineoplastic agents, bevacizumab, ciclosporin, diclofenac, human immunoglobulin for intravenous injection, linezolid, tacrolimus, thalidomide, and measles vaccine. The mechanisms of druginduced RPLS remain unclear. Early diagnosis and treatment are rather important because delayed or inadequate therapy could lead to irreversible damage. However, with timely and appropriate management, RPLS is reversible in the majority of cases. Treatment strategies for druginduced RPLS include the withdrawal of suspected drugs, control of blood pressure and seizures, and dehydration.

  • 病例报告
    . 2000, 2(1): 51-52.
  • Li Xue, Zhang Ying, Yang Zongyan, Chen Wen, Tian Jiayue, Cai Ruijuan, Wang Yan, Liu Shuo
    Adverse Drug Reactions Journal. 2021, 23(4): 219-221. https://doi.org/10.3760/cma.j.cn114015-20201019-01049
    A 53-year-old female patient with multiple metastases of colon cancer was treated with regorafenib 120-mg/d orally (21 days of medication and 7 days of withdrawal was defined as 1 cycle). On the 7th day of regorafenib treatment, the patient developed intermittent pain in the right upper abdomen and waist, which was gradually aggravated. After 20 days of waist pain, renal ultrasound and abdominal CT examination showed a right perirenal subcapsular hematoma and laboratory tests showed hemoglobin 99-g/L and normal coagulation function. Spontaneous perinephric hematoma due to regorafenib was considered. Regorafenib was discontinued, the patient was instructed to stay in bed, and hemostasis and rehydration therapy was given. After 11 days of drug withdrawal, the patient′s lumbar pain was improved and hemoglobin returned to 102-g/L. After 2 months of drug withdrawal, abdominal ultrasound showed that the right perirenal hematoma was reduced and hemoglobin returned to normal.
  • . 2015, 17(2): 87-88.
  • 病例报告
    Liu Furong;Tian Yingping;Shi Hanwen;Tong Fei;Yao Dongqi
    . 2008, 10(1): 0-0.

    Three female patients, aged 23, 26, and 29 years, respectively, received IV clindamycin 0.9, 1.2, and 1.2 g dissolved in 250500 ml of sodium chloride 0.9% for upper respiratory tract infection. During or after the infusion, they all developed general asthenia, numbness and weakness in all extremities, and walking difficulties. Physical examination showed decreased muscular tone in the four limbs with the upper limbs muscle strength of grade 1-2 and the lower limbs muscle strength of grade 1, hypoactive patellar tendon reflex, and negative Babinski sign. An ECG revealed atrial premature beats (1 case) and sinus tachycardia (2 cases). Their serum potassium levels were 2.3 mmol/L, 2.1 mmol/L, and 2.0 mmol/L, respectively. After treatment with oral and IV potassium, the symptoms resolved completely, and their serum potassium levels returned to normal ranges.

  • 不良事件
    . 2006, 8(1): 66-66.
  • WHO信息
    . 2003, 5(1): 62-62.
  • 不良事件
    . 2003, 5(3): 203-203.
  • 病例报告
    . 2000, 2(3): 197-197.
  • 病例报告
    . 2000, 2(3): 190-191.
  • 不良事件
    . 2003, 5(1): 55-55.
  • 病例报告
    . 2001, 3(4): 251-252.
  • 不良事件
    . 2005, 7(3): 231-231.
  • 不良事件
    . 2002, 4(1): 56-57.
  • WHO信息
    . 2002, 4(1): 60-61.
  • 不良事件
    . 2003, 5(4): 272-273.
  • Xiao Yange, Li Li, Li Lele, Pei Yu, Jin Nan, Ba Jianming, Dou Jingtao
    . 2017, 19(4): 305.
    A 14-year-old adolescent woman with Tourette syndrome received tiapride hydrochloride and Jingling Koufuye (静灵口服液). She received tiapride hydrochloride for 1 year and Jingling Koufuye for 11 months. Three months after treatments, she developed amenorrhoea; 1 year later, she developed  hyperprolactinemia (serum prolactin 5.11 nmol/L). The dosage of tiapride hydrochloride was reduced gradually and stopped within 2 weeks. About 1 week after drug withdrawal, her menstruation started again and 5 weeks after drug withdrawal, her serum prolactin was 0.48 nmol/L. At 4 months of follow-up, her menstrual cycle and menstrual blood volume returned to normal.
  • Gao Yue, Zhang Yanli
    Adverse Drug Reactions Journal. 2020, 22(9): 530-532. https://doi.org/10.3760/cma.j.cn114015-20190909-00749
    Three patients (patient 1, a 52-year-old female, with a history of hepatitis; patient 2, a 64-year-old female; patient 3, a 61-year-old female) were all treated with morodan concentrated pill (16 pills, thrice daily for all) for chronic gastritis. In patient 1, there were no combined drugs; in patient 2, sodium rabeprazole enteric-coated tablets were also used; in patient 3, sodium rabeprazole enteric-coated tablets and rebamipide tablets were combined. Patient 1, patient 2, and patient 3 developed abnormal liver function after 27, 22, and 19 days of morodan concentrated pill administration, respectively. Their alanine aminotransferase (ALT) increased by more than 5 times the upper limit of the reference value, accompanied by elevated bilirubin in patient 2 and patient 3. All the 3 patients were stopped to use morodan concentrated pill immediately. After 18, 22, and 24 days of liver-protective treatments, the liver function of patient 1, patient 2, and patient 3 returned to normal, respectively.
  • Adverse Drug Reactions Journal. 2019, 21(3): 218-222. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.011
  • ADR咨询
    . 2002, 4(1): 63-63.
  • 安全信息
    . 2012, 14(3): 159-1.
  • 安全信息
    . 2012, 14(4): 236-1.
  • ADE简报
    . 1999, 1(3): 192-192.
  • Zhang Xianglin
    Adverse Drug Reactions Journal. 2019, 21(3): 162-165. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.002
    Methotrexate (MTX) has been used clinically for nearly 70 years. It has been proved in practice that MTX is effective in some hematologic neoplasms and autoimmune diseases, but it has strong toxic side effects and needs individualized medication. Polymorphisms of some genes affecting MTX metabolism, transport and target of action, such as methylenetetrahydrofolate reductase (MTHFR) C677T and A1298C, gamma-glutamyl hydrolase (GGH) C401T and C16T, solute carrier family 19-A1 (SLC19A1) G80A, are closely related not only to efficacy, but also to toxic side effects of MTX therapy. However, the results of different studies are quite different. At present, it is not possible to use these genetic polymorphisms to guide clinical individualized treatment accurately. Blood concentration monitoring is still the main method of MTX monitoring.
  • . 2015, 17(2): 97-99.
  • 病例报告
    Li Lihua;Zhao Yilei;Wu Xingfan
    . 2008, 10(1): 0-0.

    A 56yearold man took celecoxib 200mg for rheumatic arthritis. About 2 hours later, he developed sporadic erythema multiforme on the upper limbs, and then it progressed to involve his entire body, accompanied with calor, pruritus, and effusion. The patient presented with a fever (T 38℃), chest pain, dysuresia, edema of the eyelids and upper lip, and hyperaemia of oral mucosa and urethral orifice. Laboratory test showed a WBC count of 10.5×109/L with 70.9% neutrophils and 20.1% lymphocyte. The symptoms were relieved three days after anti-anaphylactic and symptomatic treatment. One week later, erythema almost completely faded, but marked pigmentation remained in the skin lesions.

  • 安全合理用药
    Wang Chunyun
    . 2008, 10(1): 0-0.

    Risperidone is widely used atypical antipsychotic drug in clinical practice, which has antagonistic actions at dopamine type 2 (D2), serotonin type 2 (5-HT2), α1 and α2 adrenergic, and histamine H1 receptors in varying degrees. Blockade of dopamine D2 receptor results in extrapyramidal effects and hyperprolactinemia. Blockade of 5-HT2 and histamine H1 receptors leads to weight gain and hyperglycemia. Other common adverse reactions are insomnia, anxiety, headache, drowsiness, concentration difficulties, constipation, nausea, vomiting, blurred vision, rash, orthostatic hypotension, hypertension, tachycardia, and sexual dysfunction.

  • Zhu Kongcai, Liu Wei
    Adverse Drug Reactions Journal. 2024, 26(6): 363-368. https://doi.org/10.3760/cma.j.cn114015-20231220-00921
    Objective To explore the safety of restarting immunotherapy in patients with ≥grade 3 immune checkpoint inhibitor-related immune mediated hepatitis (IMH). Methods The diagnosis and treatment of a patient with grade 4 IMH and restarting immunotherapy who was admitted to Beijing Youan Hospital, Capital Medical University was reported, and the main clinical data of the patient and related cases collected from PubMed, Embase, Cochrane Library, CNKI, and Wanfang databases (as of November 2023) were analyzed statistically from 5 aspects such as the study type, initial immunotherapy, severity of liver toxi- city, resumption of immunotherapy, and recurrence rate of IMH after restarting immunotherapy. Results A total of 17 relevant literature were collected, including 13 retrospective case series studies, 1 prospective study, and 3 case reports. One hundred and eleven patients who experienced ≥grade 3 IMH and restarted treatment with immune checkpoint inhibitors (ICIs) were extracted. Along with one case reported by our hospital, there were totally 112 cases. After restarting ICIs treatment, the recurrence rate of IMH was 22.3% (25/112). The recurrence rate in patients with cytotoxic T lymphocyte associated antigen 4 (CTLA-4) inhibitors in the ICIs treatment regimen was higher than those without CTLA-4 inhibitors, and the difference were not statistically significant [30.0% (6/20) vs. 21.1% (19/90), χ2=0.736, P=0.279]. The recurrence rate of IMH in patients with original treatment regimen was higher than those with adjusted treatments, and the difference were not statistically significant [22.2%(6/27) vs. 17.4%(8/46), χ2=0.256, P=0.613]. Conclusion Restarting ICIs treatment in patients with ≥grade 3 ICI-related IMH after weighing the pros and cons may benefit some patients.
  • Du Hu, Chen Xiaodong, Hu Xiao, Huang Wenqi
    Adverse Drug Reactions Journal. 2024, 26(3): 186-188. https://doi.org/10.3760/cma.j.cn114015-20230724-00548
    A 30-year-old female patient with acute myeloid leukemia received chemotherapy with IA regimen of cytarabine (200-mg/m2 once daily by IV infusion, 7 days in total) and idarubicin (10-mg/m2 once daily by IV infusion, 3 days in total). On the 5th day of treatments, the patient developed dyspnea, with breath rate 35 times/min and finger pulse oxygen saturation 92%. She was treated with high flow oxygen inhalation, but the patient′s dyspnea was aggravated at night, with heart rate 160 times/min and breath rate 50 times/min; the finger pulse oxygen saturation decreased to 50%. Lung CT examination next day showed bilateral alveolar pulmonary edema with interstitial pulmonary edema, which was considered as non- cardiogenic pulmonary edema caused by cytarabine. Chemotherapy drugs were stopped and glucocorti- coids, diuresis, lung protective ventilation, prone position ventilation, and other treatments were given, but the patient′s relevant symptoms were not improved. Ten days later, the patient developed secondary pneumothorax and died due to respiratory failure.
  • Tang Yan, Zhang Juan, Zhang Shujie, Jiang Yan, Zhou Xiang
    Adverse Drug Reactions Journal. 2024, 26(8): 506-509. https://doi.org/10.3760/cma.j.cn114015-20231018-00740
    A 74‑year‑old female had multiple episodes of dizziness, palpitations, and sweating, among the 2 episodes, her venous blood glucose levels were 2.4 mmol/L and 2.5 mmol/L, C‑peptide levels were 6.79 mg/L and 6.24 μg/L, insulin >1 500 mU/L, and synchronous proinsulin levels were 2 896 ng/L and 2 989 ng/L. The patient′s urinary ketone bodies was negative, and insulin autoantibodies (IAA) was >400 RU/ml. These indicators were accorded with insulin mediated hypoglycemia. The patient had a history of taking omeprazole intermittently, had no history of diabetes, and refuted the history of using exogenous insulin, sulfonylureas and sulfhydryl drugs. Based on physical examination and relevant examinations, combined with the patient′s human leukocyte antigen (HLA) classification (HLA‑DRB1 04∶03) and medication history, it was considered that the patient was more likely to have omeprazole‑induced insulin autoimmune syndrome. Omeprazole was stopped. After adjusting the dietary structure and adding acarbose treatment for 3 months, the patient′s IAA level decreased to 36 RU/ml, and the fasting insulin decreased to 131.7 mU/L; after 9 months, the patient′s IAA turned negative and their fasting insulin decreased to 23.3 mU/L, with no further episodes of hypoglycemia.
  • Chen Tingting, Chen Chaoxin, Zeng Fanxiang, Zhang Jinhua
    Adverse Drug Reactions Journal. 2024, 26(2): 82-86. https://doi.org/10.3760/cma.j.cn114015-20230607-00415
    Objective To analyze the spontaneous reports on adverse drug reaction (ADR) in a hospital and to mine the risk signals of drug that might be associated with cardiac and neurological ADRs in pregnant women. Methods The ADR reports in the database of China Hospital Pharmacovigilance System reported by Fujian Maternal and Child Health Hospital from January 1st, 2000 to December 31st, 2022 was downloaded. ADR reports about pregnancy women were collected, and the proportions and clinical manifestations of ADRs classified as "cardiac disorders" and "nervous system disorders" according to systems and organs were analyzed by descriptive statistic method. Data mining was conducted on drugs that might be associated with cardiac disorders and nervous system disorders in ADR reports using the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method. The definition of risk signals in ROR method was the number of adverse reaction/event reports on the target drug (a) ≥3, and the lower limit of the 95% confidence interval (CI) of ROR >1. The definition of risk signals in BCPNN method was the information component minus twice the standard deviation (IC-2SD) >0. When the calculation results of an adverse reaction/event was in accordance with above-mentioned conditions in both methods, a suspected drug risk signal was determined. Results A total of 783 ADR reports about pregnancy women were included in the analysis. Ninety-four reports (12.0%) were about cardiac disorders, mainly manifested as palpitations; 121 reports (15.5%) were about nervous system disorders, mainly characterized by trembling and dizziness. These ADRs of cardiac disorders and nervous system disorders often occurred in the third trimester of pregnancy. Through the ROR and BCPNN methods, results showed that ritodrine hydrochloride injection (a=61, ROR=14.64, the lower limit of 95%CI=9.08; IC-2SD=1.36) and ritodrine hydrochloride tablets (a=24, ROR=8.34, the lower limit of 95%CI=4.64; IC-2SD=1.10) were risk signals of drug leading to cardiac disorders during pregnancy, while magnesium sulfate injection (a=37, ROR=6.66, the lower limit of 95%CI=4.10; IC-2SD=0.98) and ritodrine hydrochloride injection (a=45, ROR=3.72, the lower limit of 95%CI=2.44; IC-2SD=0.56) were risk signals of drug leading to nervous system disorders during pregnancy. Conclusion Ritodrine and magnesium sulfate may be associated with cardiac and nervous system ADR in women during pregnancy, which should arouse clinical vigilance.
  • 病例报告
    . 2006, 8(4): 302-303.
  • ADE简报
    . 2000, 2(4): 264-265.
  • 病例报告
    . 2003, 5(6): 407-408.
  • WHO信息
    . 2004, 6(3): 203-203.
  • 病例报告
    . 2002, 4(2): 120-121.
  • 病例报告
    . 2003, 5(5): 336-337.
  • 不良事件
    . 2005, 7(6): 465-465.
  • Wang Liping, Xu Wentao, Zhu Yun, Wang Ruilin
    . 2016, 18(6): 469.
    A 33-year-old male patient drank raw polygonum multiflorum medicinal wine (prepared by raw polygonum multiflorum 500 g+40% wine 1 000 ml) 50 ml/d to invigorate Yang. Four weeks later, he developed abdominal distension. Six weeks later, he developed yellow urine. Seven weeks later, he developed pruritus, dyspepsia and fatigue. The wine was stopped by himself. One week later, laboratory examination showed the following results: alanine aminotransferase 1 406 U/L, aspartate aminotransferase 546 U/L, gamma-glutamyl transpeptidase 203 U/L, total bilirubin 204.0 μmol/L, direct bilirubin 159.6 μmol/L, alkaline phosphatase 195 U/L, total bile acid 228 μmol/L, and C-reactive protein 10.5 mg/L. Abdominal CT showed signs of fatty liver, abnormal strengthened focus in left inner lobe of the liver and cholecystitis. The patient was treated with IV infusions of compound glycyrrhizin 100 mg, glutathione 1.8 g/d and polyene phosphatidylcholine 697.5 mg once daily. Two weeks later, a liver biopsy was performed, the hepatic pathology showed changes indicating acute drug-induced liver injury. Liver-protective treatments were continued. Eleven days later, laboratory tests showed alanine aminotransferase 43 U/L, aspartate aminotransferase 19 U/L, gamma-glutamyl transpeptidase 61 U/L, total bilirubin 29.0 μmol/L, direct bilirubin 22.3 μmol/L, alkaline phosphatase 88 U/L, total bile acid 17 μmol/L.
  • . 2017, 19(2): 159-159.
  • Chen Bin, Zhang Ping, Chen Jianghua
    ObjectiveTo explore the effects of dialysate calcium concentrations (DCC) on risks of adverse reactions occurred in maintenance hemodialysis patients during dialysis.MethodsThe subjects were end-stage renal disease (ESRD) patients in stable condition who were treated with maintenance dialysis in the First Affiliated Hospital, Zhejiang University from June to October 2016. According to the DCC, the patients were randomly divided into 3 groups, the 1.25 mmol/L group, the 1.35 mmol/L group, and the 1.50 mmol/L group; the observation time was 12 weeks. The urea clearance index Kt/V, urea reduction rate (URR), mean arterial pressure before and after dialysis, the serum calcium, serum phosphorus, intact parathyroid hormone (iPTH), and alkaline phosphatase (ALP) levels before and after dialysis, and the incidence of muscle spasm, nausea and vomiting, headache, chest tightness, and arrhythmia in hemodialysis patients in the 3 groups were compared.ResultsA total of 273 patients entered the study, including 159 males and 114 females with ages from 25 to 83 years and average age of (52±9) years. Each of the 1.25 mmol/L, 1.35 mmol/L, and 1. 50 mmol/L groups comprised 91 patients. The differences of baseline data in patients in the 3 groups were not statistically significant (P>0.05). After 12 weeks of hemodialysis, the differences of Kt/V and URR in patients in the 3 groups were not statistically significant (all P>0.05);the differences of the mean arterial pressures in patients in the 1.25 and 1.35 mmol/L groups [(102±9) and (103±11) mmHg, respectively] were not statistically significant (all P>0.0.5); the mean arterial pressure in the patients in the 1.50 mmol/L group was higher than that before hemodialysis [(120±12) mmHg vs. (103±9) mmHg, P<0.01] and was higher markedly than that in 1.25 and 1.35 mmol/L groups (all P<0.01); the serum calcium level in patients in the 1.25 mmol/L group was lower than that before hemodialysis [(1.94±0.31) mmol/L vs. (2.24±0.18) mmol/L, P<0.01]; the serum calcium level in the patients in the 1.50 mmol/L group was higher than that before hemodialysis [(2.54±0.18) mmol/L vs. (2.24±0.17) mmol/L, P<0.01]; the iPTH and ALP levels in patients in the 1.25 mmol/L group were higher than those before hemodialysis [(356±68) U vs. (291±49) U, (443±45) U vs. (343±58) U, all P<0.01]. During dialysis, the incidence of muscle spasm in patients in the 1.25 mmol/L group was higher than that in the 1.35 mmol/L and 1.50 mmol/L groups [14.28%(13/91) vs. 5.49%(5/91) and 4.39%(4/91), all P<0.05]; the incidence of headache in patients in the 1.50 mmol/L group was higher than that in the 1.25 mmol/L and 1.35 mmol/L groups [14.28%(13/91) vs. 3.30%(3/91) and 5.49%(5/91), P=0.01 and P<0.05]. The differences in incidences of chest tightness, arrhythmia, nausea and vomiting were not statistically significant (all P>0.05).ConclusionThe dialysate with calcium concentration of 1.35 mmol/L may reduce the incidence of muscle spasm, does not increase the incidence of hypertension and headache, and effectively reduce the risk of adverse reactions in maintenance hemodialysis patients, while ensuring the adequacy of dialysis.
  • ADR咨询
    . 2006, 8(6): 469-469.
  • ADR咨询
    . 2005, 7(5): 395-395.
  • Li Ping, Liang Linlang, Shao Xiaodong, Ren Linan
    Adverse Drug Reactions Journal. 2019, 21(3): 235-236. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.018
    A 78-year-old male patient received intravenous infusion of levofloxacin 0.5 g once daily due to pneumonia. No other drugs were used during the same period. After medication, the patient′s cough and expectoration relieved gradually. However, about 1 week after the medication, skin redness and itching on the face, neck and shoulder, abdominal distension, and muscle pain and weakness appeared and worsened progressively. After 12 days of treatment, levofloxacin was discontinued. The symptoms did not improve 1 week after the drug withdrawal and the patient was hospitalized. On admission, physical examination showed grade 4 and 3 respectively for the upper and lower limbs muscle strength; laboratory tests showed the serum creatine kinase (CK) 9 952 U/L, creatine kinase isozyme (CK-MB) 101 U/L, and myoglobin (Mb) 953 μg/L; muscle biopsy and pathological examination showed partial muscle fiber degeneration, muscle bundle rupture, increased number of myonuclei, slight inflammatory cell infiltration among some muscle bundles, and a little local mucin deposition. Allergic rash and rhabdomyolysis were diagnosed, which was considered to be induced by levofloxacin. Symptomatic supportive treatments such as anti-allergy, alkaline urine, diuresis, and fluid infusion were given. One week later, the rash subsided; 3 weeks later, the patient had no muscle pain and his muscle strength of upper and lower limbs returned to grade 5 and 4, with CK 423 U/L, CK-MB 15 U/L, and Mb 128 μg/L. Then the patient was discharged from the hospital and did not take any medicine again. One month later, his muscle strength of limbs recovered and the laboratory tests showed CK 143 U/L, CK-MB 12 U/L, and Mb 62 μg/L.
  • Zhang Xiufang,Si Jigang
    . 2016, 18(5): 392.
    An 83-year-old woman with coronary heart disease, diabetes mellitus, chronic enteritis and hypoproteinemia was received amiodarone hydrochloride (2 mg/ml) continuously because of atrial fibrillation. Amiodarone hydrochloride was given by venous pump via her left and right lower extremity dorsal veins for 4 and 3 days, respectively. The skin of injection sites on her double feet appeared cover surfaces of ulcers with diameter of 5 cm on 6 and 9 days after intravenous administration, respectively. She was diagnosed as ulcer due to amiodarone′s local stimulation. The patient received surgical debridement, regular dressing, an IV infusion of meropenem for preventing infection, and intravenous injection of alprostadil for improving microcirculation. Thirteen days later, the fresh granulation appeared on her double feet ulcer surface, the area of ulcer was  lessened, and the exudate reduced. Forty-six days later, her ulcer was healed.
  • Li Yan, Wang Yanning, Hu Yali, Wang Yang
    . 2016, 18(5): 386.
    A 5-year-old young girl with pelada received compound glycyrrhizin tablets (1 tablet, three times daily). Two weeks after taking the medicine, 2 geloses with diameter of 2 cm appeared on her bilateral nipple, respectively.The result of breast ultrasound showed hyperplasia of mammary glands. Compound glycyrrhizin tablets were stopped. The result of return visit one month later showed that the hyperplasia of mammary glands were reduced by 50%. The result of return visit two months later showed that the hyperplasia of mammary glands disappeared.
  • 病例报告
    . 2005, 7(2): 139-140.
  • 病例报告
    . 2004, 6(3): 182-183.
  • 病例报告
    . 2005, 7(3): 209-210.
  • 病例报告
    . 2004, 6(4): 253-254.
  • 中药不良反应
    . 2006, 8(5): 392-393.
  • WHO信息
    . 2003, 5(2): 133-133.
  • 病例报告
    . 2000, 2(4): 260-261.
  • WHO信息
    . 2004, 6(3): 204-204.
  • WHO信息
    . 2001, 3(3): 208-208.
  • 滥用误用
    Zhang Kaigao
    . 2008, 10(1): 0-0.

    3.4-methylenedioxyme thamphetamine (MDMA, ecstasy) is a synthetic amphetamine derivative, which is used as a recreational substance and is widely abused among young people. MDMA targets the serotonergic system and can cause serotonin neuronal damage. The mechanism responsible for the neurotoxicitg of MDMA is probably associated with hydroxyl radical formation. MDMA abuse commonly occurs in combination with ethanol, and ethanol can increase hydroxyl radicals formation and serotonin neuronal damage.

  • 病例报告
    . 2005, 7(3): 219-220.
  • ADE简报
    . 2001, 3(4): 260-261.
  • 病例报道
    . 1999, 1(1): 53-54.
  • WHO信息
    . 2003, 5(1): 62-62.
  • Jiang Jiaxi, Sun Haiyan
    A 67-year-old female patient with systemic lupus erythematosus (SLE) complicated with hypertension and carotid atherosclerosis received oral hydroxychloroquine tablets 100 mg twice daily, total glucosides of paeony capsules 0.6 g thrice daily, mycophenolate mofetil dispersible tablets 0.5 g twice daily, nifedipine sustained-release tablets 30 mg once daily, simvastatin tablets 20 mg once daily, and aspirin enteric tablets 100 mg once daily, and an IV infusion of sodium succinate for injection 30 mg dissolved in normal saline 100 ml once daily. Six days later, IV infusion of sodium succinate for injection was changed to oral prednisone tablets 30 mg once daily. On day 13 of medication, the patient suddenly developed syncope and electrocardiogram showed high-degree atrioventricular block. It was considered that hydroxychloroquine induced the high-degree atrioventricular block. Hydroxychloroquine was discontinued while the other drugs were continued. Three days after the drug withdrawal, atrioventricular block disappeared.
  • 病例报告
    . 1999, 1(3): 188-189.
  • 病例报告
    . 1999, 1(3): 180-181.
  • Yao Xuefan, Wang Yuan, Song Haiqing
    Adverse Drug Reactions Journal. 2025, 27(2): 79-83. https://doi.org/10.3760/cma.j.cn114015-20241016-00095
    Drug-induced neurological disorders (DINDs) refer to the central or peripheral nervous system disease caused by drugs. DINDs account for a large proportion of adverse drug reactions/events in China, and its onset is complex to some extent. Common DINDs include epilepsy, movement disorders, stroke, peripheral neuropathy, spinal cord injury, cognitive impairment and so on. Usually, DINDs have characters of gradual development and late-onset reactions, and it is difficult to associate their clinical manifestations with drugs, leading to misdiagnosis and poor prognosis in clinic. To reduce the neurotoxicity of drugs, multidisciplinary cooperation should be strengthened, and individualized treatment plans for high-risk people and closer monitoring should be implemented for timely identification and diagnose. At the same time, relevant researches on DINDs should be strengthened in the clinic to cope with the complexity and long-term prognosis challenges of the diseases.
  • Zhao Tao, Zhang Xin, Su Tao
    Adverse Drug Reactions Journal. 2024, 26(12): 705-710. https://doi.org/10.3760/cma.j.cn114015-20240830-00026
    With the rapid progress of cancer treatment, the treatment of chronic kidney disease (CKD) in cancer survivors has become more and more important in clinical practice. The Japanese Society of Nephrology, Japan Society of Clinical Oncology, Japanese Society of Medical Oncology, and Japanese Society of Nephrology and Pharmacotherapy have jointly formulated the Clinical Practice Guidelines for Management of Kidney Injury During Anticancer Drug Therapy 2022, in which the epidemiology, influencing factors, and treatment options of CKD in cancer survivors was comprehensively discussed. The above guideline emphasizes the complexity of managing CKD in cancer survivors from the perspective of clinical practice, and puts forward personalized treatment recommendations for this special population. This article interprets this chapter in the guideline in order to provide reference for clinicians.
  • Hao Weiwen, Wang Lumin, Zhang Jinsong, Jiang Guiping, Sun Hao, Jin Hua, Cao Yun, Zhang Huazhong, Wang Gannan, Shi Qifang
    Adverse Drug Reactions Journal. 2024, 26(6): 331-336. https://doi.org/10.3760/cma.j.cn114015-20231117-00812
    Objective To explore the clinical characteristics of adverse reactions induced by levofloxacin in the emergency infusion unit. Methods The study was designed as a single center prospective cohort study. Data of adverse drug reaction (ADR) in the Infusion Unit of Emergency Medicine Center of First Affiliated Hospital of Nanjing Medical University was managed, recorded and collected according to the pre-formulated "emergency infusion unit drug adverse reaction management process" and "strengthening the reporting of observational studies in epidemiology (STROBE)". The incidence, severity, clinical characteristics, intervention measures, outcomes, and follow-up of adverse reactions induced by levofloxacin from November 2019 to October 2022 was summarized and analyzed. Results A total of 426 cases of ADR occurred within the set time period, of which 62 (14.55%) were related to levofloxacin, involving 27 males (43.55%) and 35 females (56.45%) with a median age of 39 years. Among the 62 levofloxacin-related ADRs, 96.77% (60/62) occurred within 2 hours of intravenous infusion of levofloxacin; the severity of 44 (70.97%), 10 (16.13%) and 8 (12.90%) cases of ADRs was classified as grade 1, 2, and 3, respectively, and no grade 4 ADRs occurred. The most common clinical symptoms were skin and mucosa reactions, including rash and itching, followed by cardiovascular system and nervous system manifestations, including hypotension, palpitation, and dizziness. The skin and mucosa manifestations were more common in patients with severity grade 1 ADRs, while the cardiovascular, digestive, respiratory nervous system and systemic manifestations were more common in those with severity grade 2 and 3 ADRs; the differences were statistically significant (all P<0.05). After the occurrence of ADRs, levofloxacin was withdrawn in all the 62 patients, the infusion set was replaced, and infusion of 0.9% sodium chloride injection were used to flush the tube. Additionally, 24 patients (38.71%) were given drug intervention, including epinephrine in 2 patients. After the above intervention, the symptoms of all patients were relieved, with a median response time of 49-minutes. Conclusions Levofloxacin was one of the common drugs causing ADR in the emergency infusion unit. The clinical manifestations were mainly rashes and itching, most of which were mild in severity. Timely disconti- nuation of levofloxacin and drug interventions often help get a good prognosis. However, the treatment procedure of severe ADRs remain to be standardized.
  • WHO信息
    . 2004, 6(1): 62-63.
  • 病例报告
    . 2006, 8(2): 138-139.
  • 病例报告
    . 2002, 4(4): 260-261.
  • 抗菌药应用
    . 2005, 7(4): 279-286.
  • 安全信息
    . 2008, 10(4): 0-0.
  • 病例报告
    . 2001, 3(1): 49-50.
  • 不良事件
    . 2006, 8(3): 226-226.
  • 病例报告
    . 2006, 8(5): 378-379.
  • 病例报告
    . 2003, 5(4): 259-260.
  • 病例报告
    . 2004, 6(5): 337-338.
  • 安全信息
    . 2006, 8(4): 309-310.
    SFDA notified health professionals and patients of acute intravascular hemolysis caused by puerarin injection.From 1 January 2003 to 30 June 2005,one thousand and six reports of suspected adverse reactions associated with puerarin injection have been reported to National Center for Adverse Drug Reactions Monitoring.Thirty of 1006 cases were serious adverse reactions.Eighteen of the 30 cases were acute intravascular hemolysis,and 8 of the 18 cases died.The symptoms of acute intravascular hemolysis were fever,lumbago,jaundice and dark urine.
  • 不良事件
    . 2006, 8(3): 223-224.
  • 病例报告
    . 2002, 4(1): 49-50.
  • WHO信息
    . 2004, 6(3): 203-203.
  • 病例报告
    . 2003, 5(3): 189-190.
  • 病例报告
    . 2002, 4(3): 196-196.
  • 病例报告
    . 2001, 3(2): 120-121.
  • 病例报告
    . 2002, 4(3): 193-194.
  • 病例报告
    . 2000, 2(1): 53-54.
  • Fan Rong, Yuan Sisi, Zhang Helen
    Adverse Drug Reactions Journal. 2019, 21(2): 123-128. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.009
    ObjectiveTo explore the risk points of medication errors of potassium permanganate external preparation in clinical application using Failure Mode and Effect Analysis (FEMA) method.MethodsA study group on prevention strategies of medication errors in potassium permanganate external preparation was set up in Beijing United Family Healthcare and Beijing Obstetrics and Gynecology Hospital. Failure modes and risk points were collected through literature review, questionnaire survey and on-the-spot investigation. Severity (S), frequency of occurrence (O), and likelihood of detection (D) of the failure modes and risk points were scored and their risk priority numbers (RPN) were determined. Failure modes and risk points with PRN scores >150 were defined as high risk points and corresponding  prevention strategies were formulated.ResultsAccording to the literature reports, medication errors in potassium permanganate external preparation occurred mainly in the link of patient medication, and the main place was the patient′s home. After comprehensive evaluation, a total of 20 risk points in 6 circulation links (physician prescription, drug dispensing, medication administration by nurses, and patient medication) of potassium permanganate external preparation were found, of which 9 risk points were with RPN>150. They were as follows: (1) the potassium permanganate external tablets looked similar to the oral tablets and were easy to be taken orally by mistake; (2) there were no striking tips of "For External Use Only" and "External Use After Dilution " on drug packages; (3) high concentrations of external tablets or powder could be directly exposed to skin; (4) drug dilution concentration was guided by solution color; (5) patients did not know how to use the drug due to inadequate information communication; (6) failure to clearly inform patients how to use potassium permanganate external preparation and the precautions; (7) hospital information system did not remind the drug dilution method; (8) target concentration after dilution was not noted in the prescription; (9) the patient′s body or clothing might be dyed during medication.ConclusionFMEA method could effectively identify risk points of potassium permanganate external preparation in clinical application, help medical institutions formulate management strategies, and guarantee the medication safety in patients.
  • Ji Wen, Wang Shuping, Tang Zhenguo, Zhang Wen
    Adverse Drug Reactions Journal. 2024, 26(4): 204-210. https://doi.org/10.3760/cma.j.cn114015-20230817-00610
    Objective To explore the clinical characteristics of cardiotoxicity due to 5-hydroxytryptamine 3 receptor (5-HT3) antagonists. Methods Relevant databases at home and abroad (up to June 20, 2023) were searched and case literature of cardiotoxicity induced by 5-HT3 receptor antagonist were collected. Relevant information of patients, medication status (drug name, usage and dosage, indication, combined drugs), occurrence of cardiotoxicity, evaluation of the association between 5-HT3 receptor antagonists and cardiotoxicity, intervention measures and outcomes were extracted and analyzed descriptively and statistically. Results A total of 23 case reports, 22 in English and 1 in Chinese, were enrolled in the analysis. There were 26 patients, 6 males and 20 females, and the age ranged from 8 to 60 years, with an average of 40 years. The reasons for drug use were perioperative antiemesis in 19 patients, chemotherapy antiemesis in 2 patients, and other reasons in 5 patients. Ondansetron was used in 19 patients, dolasetron in 4 patients, granisetron, tropisetron and palonosetron in 1 patient each. Except for 1 patient with overdose by self-medication, the dosage in 25 patients was within the recommended range in labels. A total of 50 case time of cardiotoxicity occurred in 26 patients, mainly including tachycardia (12 cases), electrocardiogram (ECC) changes (11 cases), bradycardia (9 cases), cardiac arrest (1 case), and myocardial infarction (1 case), etc. Twenty-one patients experienced cardiotoxicity after initial medication, of which 8 occurred immedia- tely after the initial medication, 5 patients occurred after ≥2 times of medication. After the occurrence of cardiotoxicity, 26 patients stopped 5-HT3 receptor antagonists successively, of which 24-stopped the drug immedia- tely and received symptomatic treatments, 1 stopped the drug after 8 days of medication without other intervention, and 1 stopped the drug and received symptomatic treatment after the symptoms aggravated. After drug withdrawal and/or symptomatic treatments, the mentioned symptoms disappeared and ECC returned to normal in 25 patients. Of them, 22 patients had a recovery time of ≤48-hours, while the other 3 patients had their ECG returned to normal at 1 week, 2 weeks, and 2 months, respectively; one patient died due to ineffective treatment for ventricular fibrillation. Conclusions The cardiotoxicity induced by 5-HT3 receptor antagonists mostly occurs after the initial medication, and mainly manifests as tachycardia, bradycardia, ECG changes, etc. Most patients have a good prognosis after timely drug withdrawal and symptomatic treatments, and in severe cases, it can lead to death.
  • Wu Dongqin, Qin Zhihong, Yang Zhixiang, Wei Huabo
    Adverse Drug Reactions Journal. 2023, 25(12): 755-756. https://doi.org/10.3760/cma.j.cn114015-20220929-00884
    A 73-year-old male patient with right lung squamous cell carcinoma developed edema of bilateral lower limbs, poor appetite, and oliguria after targeted treatment with afatinib 30-mg once daily orally for 80 days. The laboratory tests showed serum creatinine 658-mmol/L, blood urea 26.8 mmol/L, urine protein (++++), and urine occult blood (+++). Renal biopsy showed renal tubular injury, some cells appearing as crescents, and mild IgA deposition. Acute kidney failure was diagnosed, which was considered to be caused by afatinib. Afatinib was stopped and symptomatic treatments including hemodialysis, glucocor- ticoids, anticoagulants, diuretics, etc. were given. Twelve days later, the edema in both lower limbs was alleviated;19 days later, his daily urine volume was approximately 800 ml; 99 days later, his renal function indicators tended to be normal. The patient did not receive targeted treatment again.
  • Shen Jianghua, Liu Miao, Liu Chen, Liu Qian, Chu Yanqi, Feng Xuexin
    Adverse Drug Reactions Journal. 2024, 26(10): 627-630. https://doi.org/10.3760/cma.j.cn114015-20240108-00013
    A 50-year-old male patient was scheduled to undergo epiglottic mass resection under general anesthesia due to an epiglottic cyst. Before anesthesia induction, the patient received dexamethasone, methylprednisolone, midazolam, and ondansetron by intravenous injectionin sequence. After 2 minutes, the patient complained of palpitations, abdominal spasmodic pain, cyanosis of the lips, and patchy changes in the skin on the chest and body. The electrocardiogram monitor showed a heart rate of 175 beats per minute, but his cuff blood pressure cannot be measured. His blood oxygen saturation was 0.76, and he did not respond to the call afterwards. Oxygen through a face mask and pressure ventilation, intravenous injection of 20 mg of esmolol twice were given immediately. The patient′s consciousness recovered, the heart rate gradually decreased to 60 beats per minute (sinus rhythm), and the blood pressure increased to 74/50 mmHg. Continuous IV pumping of norepinephrine 8 μg/min was given. After 25 minutes, the patient′s bedside electrocardiogram showed atrial fibrillation with ventricular differential conduction, myocardial injury or acute myocardial infarction, and QT interval prolongation. Then intravenous injection of furosemide 40 mg was given, his above symptoms were improved,his blood pressure recovered to 110 120/70 mmHg, blood oxygen saturation was 1.00, the skin spots on his chest and body disappeared, and his abdominal pain was alleviated. Anesthesiologists and pharmacists evaluated the patient′s adverse reactions and considered that there was a high possibility of type I Kounis syndrome caused by the combination of glucocorticoids, midazolam, and ondansetron.
  • Adverse Drug Reactions Journal. 2019, 21(2): 97-97. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.004
  • ADR咨询
    . 2002, 4(4): 281-281.
  • WHO信息
    . 2001, 3(4): 264-264.
  • ADE简报
    . 2000, 2(3): 200-201.
  • 病例报告
    He Xuemei;Zhao Ban;Mao Yonghui
    . 2008, 10(1): 0-0.

    A 57yearold woman, with a history of type 2 diabetes mellitus, hypertension, and cerebral infarction, was hospitalized with acute aggravated chronic renal failure. During hospitalization, she started receiving IV acyclovir 500 mg twice daily for herpes zoster infection. On day 3 after the IV acyclovir treatment, she developed disturbance of consciousness, disorientation, and somnolence. There was no obvious change in her serum electrolyte, serum creatinine, and haemoglobin levels, and in body temperature. An examination on nervous system revealed no positive signs. A head CT scan displayed new and old cerebral infarctions. Cinepazide was given and the dose of acyclovir was reduced to 500 mg once daily. However, the patient’s disturbance of consciousness continued to worsen. After withdrawal of acyclovir and dialysis therapy for 3 successive days, the patient regained normal consciousness rapidly.

  • WHO信息
    . 2002, 4(1): 61-62.
  • 病例报告
    . 2000, 2(4): 254-255.
  • 病例报告
    . 2006, 8(5): 380-381.
  • 监测简报
    . 2003, 5(4): 265-266.
  • WHO信息
    . 2004, 6(3): 204-204.
  • WHO信息
    . 2001, 3(3): 207-208.
  • WHO信息
    . 2004, 6(4): 276-276.
  • 病例报告
    . 2000, 2(3): 192-193.
  • WHO信息
    . 2003, 5(5): 353-354.
  • 病例报告
    . 2004, 6(3): 186-187.
  • 不良事件
    . 2005, 7(1): 68-69.
  • Institute for Safe Medication Practices, Zong Yutong1, Zhang Qingxia2, Yan Yuanyuan, Lu Lu, Shao Chen, Wang Zimin, Qiu Yujie, Yan Suying
    Adverse Drug Reactions Journal. 2019, 21(2): 135-139. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.012
    The Institute for Safe Medication Practices (ISMP) issued 2017 ISMP Medication Safety Self Assessment for antithrombotic therapy. It was a revision of the 2005 version of the self assessment, mainly including medication safety strategies for the new oral anticoagulants. The 2017 version of the self assessment included 8 key elements and 11 core characteristics, aiming to help the medical institutions assess the medication safety practices of antithrombotic therapy.
  • Wu Rui, Zhu Congcong, Li Xiaoyu, Wang Leiming, Zhao Yi
    Adverse Drug Reactions Journal. 2019, 21(6): 420-424. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.004

    ObjectiveTo explore the effects of self-established method of modified hydration on the acute-phase reaction (APR)of zoledronic acid injection.MethodsThis study was designed as randomized controlled trial. The subjects were inpatients with rheumatism and osteoporosis who were intended to receive zoledronic acid injection for the first or second time in Department of Rheumatology & Immunology, Xuanwu Hospital, Capital Medical University from August 2016 to December 2017. The patients who meet the inclusion criteria were randomly divided into the modified hydration group and the routine hydration group. The patients in the modified hydration group received IV infusions of 0.9% sodium chloride injection 500 ml before and after IV infusion of zoledronic acid injection, respectively and water 750 ml measured with mould under the care of nurses within 2 hours before and after medication, respectively. The total amount of liquid was more than 2 500 ml. The patients in the routine hydration group were only told to drink a large amount of water before and after IV infusion of zoledronic acid injection. The total amount of liquid was required to be more than 2 000 ml, but the water measuring mould was not provided. After IV infusion, the intravenous infusion tube was washed by 0.9% sodium chloride injection 100 ml. The total amount of liquid was more than 2 000 ml. The incidence of APR within 3 days of medication and levels of serum creatine on day 3 of medication in patients in the 2 groups were compared. ResultsA total of 190 patients were enrolled in the study, including100 and 90 patients in the modified hydration group and the routine hydration group, respectively. The differences of sex distribution, age, proportion of patients with zoledronic acid injection for the first or second time, minimum bone mineral density T value before medication, and the levels of serum creatine before medication between the 2 groups were not statistically significant (P>0.05 for all). The incidences of APR and fever in the modified hydration group were significantly lower than those in the routine hydration group [40.0% (40/100) vs.68.9% (62/90), P<0.01; 23.0% (23/100) vs. 44.4% (40/90), P<0.01] within 3 days of IV infusion of zoledronic acid injection. The incidences of APR and fever in patients treatment with zoledronic acid injection for the first or second time in the modified hydration group were significantly lower than those in the routine hydration group [first medication: 53.3% (32/60) vs. 73.6% (39/53), 30% (18/60) vs. 50.9% (27/53); second medication:20.0% (8/40) vs.62.2% (23/37), 12.5% (5/40) vs. 35.1% (13/37)]; the incidences of APR and weakness in patients treatment with zoledronic acid injection for the second time were significantly lower than those for the first time[20.0% (8/40) vs. 53.3% (32/60), 17.5%(7/40) vs. 41.7% (25/60)]; the incidence of headache in patients treatment with zoledronic acid injection for the second time in the routine hydration group were significantly lower than those for the first time[0 (0/37) vs. 13.2% (7/53)]; all above-mentioned differences were statistically significant (P<0.05 or P<0.01). No patients developed acute kidney injury in the 2 groups. The levels of serum creatine in the 2 groups were (52±20) and (52±13) μmol/L, respectively.ConclusionThe modified hydration method can decrease the incidence of APR effectively in patients with zoledronic acid injection treatment for the first or second time.

  • Yang Shuiyuan, Tong Yanli, Zeng Siyu, Mei Qinghua, Lu Huiqin
    . 2016, 18(5): 388.
    A 52-year-old male patient with severe craniocerebral injury and hyperthyroidism was given nasal feeding methimazole 10 mg twice daily and propranolol 10 mg thrice daily. On day 4, the patient developed red papules which involve neck, body, and forearm. Methimazole′s dosage was halved and he received an IV infusion of dexamethasone 10 mg twice daily and nasal feeding loratadine 10 mg once daily. On day 6, the patient developed maculopapular eruptions on the face and neck, some rashes fused into lamella, blisters emerged on the neck and trunk, accompanied by high fever. Bronchoscopy showed the airway congestion, erosion and bloody sputum. Methimazole was withdrawn and anti-anaphylactic treatment was continued. On day 7, a large area of exfoliation appeared. Methimazole-induced epidermal necrolysis was diagnosed. He received IV infusions of human immunoglobulin 20 g once daily and methylprednisolone 60 mg twice daily. On day 12, wound exudates were reduced. Human immunoglobulin was withdrawn and the dosage of methylprednisolone was changed to 40 mg twice daily. One month later, the body skin base was bright red and a small amount of purulent secretions appeared. Methylprednisolone was withdrawn. Six months later, the surface of wound and scars healed.
  • Xu Zhiyu, Dong Zhiheng, Zhang Aiwu
    Adverse Drug Reactions Journal. 2024, 26(8): 504-506. https://doi.org/10.3760/cma.j.cn114015-20231007-00720
    A 67‑year‑old female patient was treated with oral 4 Panlongqi tablets thrice daily for strain of lumbar muscles. The patient developed nausea and poor appetite after 3 days of administration, followed by discharging strong brown urine and clay‑colored stools. After 15 days of using the drug, she developed yellow staining of the skin and sclera, and itching appeared throughout the body. Laboratory tests showed alanine aminotransferase (ALT) 304 U/L, aspartate aminotransferase (AST) 168 U/L, alkaline phosphatase (ALP) 463.6 U/L, gamma glutamyltransferase (GGT) 1 332.3 U/L, total bilirubin (TBil) 110.5 μmol/L, and direct bilirubin (DBil) 92.3 μmol/L. After excluding viral hepatitis and biliary obstruction, drug‑induced liver injury was diagnosed. Panlongqi tablets were stopped, and magnesium isoglycyrrhizinate, polyene phosphatidylcholine, ursodeoxycholic acid, and methylprednisolone were given. The patient′s discomfort symptoms were gradually eased and liver function was gradually improved. After 14 days of treatments, percutaneous liver biopsy under color doppler ultrasound was performed, and she was diagnosed as acute cholestatic hepatitis with mild fibrosis in the portal area, possibly caused by drug. After 16 days of treatments, the medication was switched to oral hepatoprotective drugs for 2 weeks. One week after stopping treatments, the patient had no discomfort and the color of skin and sclera was normal. The liver function was normal, showing ALT 31 U/L, AST 25 U/L, ALP 83.9 U/L, GGT 37.0 U/L, TBil 19.8 μmol/L, and DBil 7.3 μmol/L.
  • Cao Jing, Gao Chunhui, Zeng Yuanyuan, Huang Wei, Chen Baoyan, Xue Zhimin, Wang Xiaoling
    Adverse Drug Reactions Journal. 2023, 25(5): 287-298. https://doi.org/10.3760/cma.j.cn114015-20221123-01048
    Objective To understand preliminarily the current status of medication safety mana- gement in pediatric medical institutions in China. Methods Self-assessment of medication safety situation were conducted in 10 pediatric medical institutions of the Pharmacy Professional Committee of Futang Children′s Medical Development Research Center using the “optimized version of 2011 Medication Safety Self Assessment- for Hospitals (161 assessment items)” (self-assessment criteria). The self-assessment criteria included 10 key elements, 20 core characteristics, and 161 assessment items. The self-assessment results on medication safety among participating institutions were summarized, and the percentage scores and implementation proportions of the key elements, core characteristics, and assessment items were descriptively analyzed. Results All 10 participating medical institutions completed the questionnaires within the specified time. The results showed that the overall percentage score of medication safety self- assessment was 74.72%. The element Ⅲ (communication of medication orders and other medicines information, 83.89%) and element Ⅹ (quality process and risk management, 67.84%) were with the highest and lowest percentage scores, respectively. The element Ⅲ (66.67%) and element Ⅸ (patient education, 40.00%) were with the highest and lowest percentage of full implementation, respectively. The element Ⅸ (46.25%) and element Ⅲ (26.67%) were with the highest and lowest percentage of partial implementation, respectively. The element Ⅹ (quality process and risk management, 18.38%) and element Ⅵ (procurement, use, and monitoring maintenance of drug treatment equipment, 6.25%) were with the highest and lowest percentage of non-implementation, respectively. Among the 20 core characteristics, characteristic 10 (guaranteeing the isolation of non-pharmaceutical chemicals from patients and avoiding harm to patients due to misuse, 96.25%) and characteristic 7 (adopting measures such as developing clinical pathways and establishing standardized administration time to ensure patients receive standardized diagnosis and treatment, 57.50%) were with the highest and lowest percentage scores, respectively. The characteristic 20 (following hospital infection control measures during drug storage, formulation, preparation, and administration, 90.00%) and characteristic 17 (establishing a fair and just drug safety culture within the hospital, encouraging and advocating safe behavior, rather than punitive measures for medical personnel related to medication errors, 25.00%) were with the highest and lowest percentage of complete implementation, respectively. The characteristic 7 (55.00%) and characteristic 20 (5.00%) were with the highest and lowest percentage of partial implementation, respectively. The characteri- stic 17 (22.86%) and characteristic 10 (0) were the highest and lowest percentage of non-implementation, respectively. Conclusions The 10 pediatric medical institutions participating in the self-assessment have a higher level of management in the communication of medication orders and other drug information, as well as in the storage and distribution of drugs. However, there are shortcomings in the construction of a fair culture, proactive prevention of medication risks, and improvement of information systems.
  • Liu Da;Wei Jun
    . 2015, 17(1): 36-4.
    ObjectiveTo investigate the efficacy and safety of dinoprostone suppositories in treatment for promoting cervical ripening.MethodsA randomized controlled clinical trial was conducted. The full-term pregnant women whose cervical conditions were not ripe in Shengjing Hospital of China Medical University from September 2011 to September 2013 were randomly divided into the dinoprostone suppositories group (one dinoprostone suppository was placed in the posterior vaginal fornix and removed 12 hours later) and the oxytocin group (an intravenous infusion of 2.5 U oxytocin in 0.9% sodium chloride solution for injection 500 ml was infused slowly) by envelope sortition method. The efficacy was evaluated by Bishop score before and 6 and 12 hours after drug administration, the first, second, and third stage labor and total labor time, and the rate of vaginal delivery. Safety evaluation index included the incidence of drug adverse reaction in the pregnant women, fetal distress, and neonatal asphyxia.ResultsThe Bishop scores 6 and 12 hours after drug administration in the dinoprostone suppositories group[(6.5±0.8) and (8.3±0.9)] were higher than the Bishop scores before drug administration in the dinoprostone suppositories group (4.2±0.6) and the Bishop scores 6 and 12 hours after giving the drug in the oxytocin group [(4.2±0.6) and (4.5±0.3)], the differences were statistically significant (all P<0.05). The total effective rate to promote cervical ripening in the dinoprostone suppositories group [85.0% (221/260) ] was significantly higher than that in the oxytocin group [23.1% (60/260) ](P=0.01). The first and second stage labor and total labor time in the dinoprostone suppositories group were significantly shorter than that in the oxytocin group (all P<0.05). The rate of vaginal delivery in the dinoprostone suppositories group [90.8% (236/260)] was significantly higher than that in the oxytocin group[46.9% (122/260)] (P=0.01). The incidence of drug adverse reaction in the pregnant women, fetal distress, and neonatal asphyxia were respectively 7.0% (18/260), 4.7% (12/256), and 3.9% (10/256) in the dinoprostone suppositories group and were respectively 6.2% (16/260), 4.8% (14/253), and 4.3% (11/253) in the oxytocin group, there were no statistically significant differences between the two groups (all P>0.05).ConclusionThe efficacy of dinoprostone suppositories for promoting cervical ripening was better than oxytocin and dinoprostone suppository showed a good safety profile.
  • Liu Jun, Liu Zhigang, Gao Yuhong, Zhao Pitian
    A 54-year-old male patient underwent percutaneous coronary intervention(PCI) twice for acute myocardial infarction. Five sirolimus-eluting stents were implanted in the first PCI and the patient developed chest distress and short of breath 5 weeks after the operation. Exertional angina was considered. The second PCI with 2 sirolimus-eluting stents implantation was conducted on day 5 after the symptoms appeared. Chest distress recurred on day 4 after the second operation and gradually aggravated. The chest distress did not relieve after 2 days of treatments of cardiac insufficiency. Laboratory tests on day 5 after the second operation showed a white blood cell count of 15.5×109/L and neutrophils of 0.90. Anti-infection therapy with cefotiam was given but the symptom did not improved and fever appeared (up to 38.5 ℃). On day 9 after the second operation, chest CT examination showed interstitial pneumonia in bilateral lungs, which were considered to be induced by sirolimus-eluting stents. Methylprednisolone, imipenem, and oseltamivir were given. Two weeks later, the patient′s symptoms improved markedly and chest CT examination showed improvement of interstitial pneumonia in bilateral lungs.
  • ADR咨询
    . 2006, 8(6): 469-469.
  • 病例报告
    . 1999, 1(3): 185-186.
  • 病例报告
    . 2003, 5(6): 402-403.
  • 系列问答
    . 2009, 11(4): 301-1.
  • WHO信息
    . 2002, 4(3): 207-207.
  • WHO信息
    . 2002, 4(3): 209-209.
  • WHO信息
    . 2004, 6(5): 351-351.
  • WHO信息
    . 2004, 6(1): 63-63.
  • WHO信息
    . 2003, 5(3): 207-207.
  • 不良事件
    . 2005, 7(6): 462-463.
  • 不良事件
    . 2005, 7(6): 464-465.
  • WHO信息
    . 2001, 3(2): 129-130.
  • ADE简报
    . 2001, 3(2): 125-125.
  • 病例报告
    . 2000, 2(1): 50-51.
  • ADR咨询
    . 2001, 3(3): 211-211.
  • ADR咨询
    . 2001, 3(4): 278-278.
  • Adverse Drug Reactions Journal. 2019, 21(6): 482-484. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.029
  • Fang Zhenwei, Shi Jia, Lin Yang
    Adverse Drug Reactions Journal. 2019, 21(2): 108-117. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.007
    ObjectiveTo evaluate the risks of amputation and fracture induced by sodium glucose co-transporter 2 (SGLT2) inhibitors (canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin).MethodsReports of amputation and fracture events induced by SGLT2 inhibitors and non-SGLT2 inhibitors received from January 1, 2004 to June 30, 2018 in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database were collected. The relationship between the drugs mentioned above and the amputation and fracture events in all patients and especially in patients with diabetes mellitus, respectively, were analyzed by the method of reporting odds ratio (ROR).ResultsA total of 1 633 reports of SGLT2 inhibitors-induced amputation (27.66% of 5 904 amputation event reports in the database during the study period) and 244 reports of SGLT2 inhibitors-induced fracture (0.21% of 114 051 fracture event reports in the database during the study period) were retrieved from the database. These reports were related to canagliflozin, dapagliflozin, and empagliflozin, but not to ertugliflozin. And a total of 4 271 non-SGLT2 inhibitors-induced amputation event reports and 113 807 fracture event reports were retrieved from the database. Of the 1 633 reports of SGLT2 inhibitor-induced amputation, 1 432 reports (87.69%) involved lower-limbs (led, foot, and toe) amputation, which had the highest proportion. The ROR values of all amputation events induced by overall SGLT2 inhibitors, canagliflozin, dapagliflozin, and empagliflozin in all patients were 92.70 (95%CI: 87.47-98.24), 150.72 (95%CI: 141.98-160.00), 6.84 (95%CI: 4.54-10.31), and 16.54 (95%CI: 12.98-21.07), respectively, and in patients with diabetes mellitus were 30.53 (95%CI: 27.81-33.51), 49.68 (95%CI: 45.19-54.62), 2.73 (95%CI: 1.75-4.27), and 5.09 (95%CI: 3.80-6.83), respectively. The  ROR  values of lower-limb amputation events induced by overall SGLT2 inhibitors, canagliflozin, dapagliflozin, and empagliflozin in all patients were 103.49 (95%CI: 97.19-110.20), 167.29 (95%CI: 156.82-178.45), 8.38 (95%CI: 5.50-12.75), and 18.63 (95%CI: 14.39-24.12), respectively, and in patients with diabetes mellitus were 30.92 (95%CI: 28.00-34.13), 49.96 (95%CI: 45.18-55.24), 2.95 (95%CI: 1.87-4.66) and 5.42 (95%CI: 4.00-7.34), respectively. The ROR values of fracture events induced by overall SGLT2 inhibitors were 0.49 (95%CI: 0.43-0.56) and 0.57 (95%CI: 0.49-0.67) in all patients and in patients with diabetes mellitus, respectively.ConclusionsSGLT2 inhibitors could increase the risk of amputation in patients, especially the lower-limb amputation. The reports of amputation induced by canagliflozin had higher proportion than those induced by dapagliflozin or empagliflozin. No significant relationship between SGLT2 inhibitors and fracture was found.
  • ADR咨询
    . 2006, 8(1): 74-74.
  • 不良事件
    . 2004, 6(2): 133-133.
  • 病例报告
    . 2002, 4(4): 265-266.
  • 病例报道
    . 1999, 1(1): 55-56.
  • Adverse Drug Reactions Journal. 2003, 5(4): 269-270.
  • 不良事件
    . 2004, 6(4): 270-271.
  • ADE简报
    . 2001, 3(3): 202-203.
  • WHO信息
    . 2004, 6(5): 350-350.
  • 药物警戒
    . 2002, 4(6): 375-375.
  • Adverse Drug Reactions Journal. 2022, 24(1): 1-2. https://doi.org/10.3760/cma.j.cn114015-20211221-01290
  • WHO信息
    . 2002, 4(1): 61-61.
  • WHO信息
    . 2004, 6(4): 275-275.
  • 不良事件
    . 2006, 8(3): 225-226.
  • 病例报道
    . 1999, 1(1): 57-57.
  • 不良事件
    . 2003, 5(5): 344-345.
  • 不良事件
    . 2003, 5(3): 202-203.
  • 不良事件
    . 2003, 5(4): 268-269.
  • 病例报告
    . 2001, 3(3): 194-195.
  • 安全合理用药
    Tao Hailong;Ma Changsheng
    . 2008, 10(1): 0-0.

    Amiodarone is a class III antiarrhythemic. It is used in the control of ventricular arrhythmias and atrial fibrillation. Amiodarone can induce a varity of adverse reactions. The one of the common serious adverse reactions to amiodarone is pulmonary toxicity. The reported incidence of amiodarone pulmonary toxicity(APT) is variable, but appears to be between 1% and 17%. Most of the patients develop interstitial pneumonitis or hypersensitivity pneumonitis after 3~12 months of amiodarone therapy. The pathogenesis of amiodarone pulmonary toxicity is uncertain. The possible mechanisms include direct cytotoxicity, hypersensitivity, inflammatory or immune response. The related factors inducing APT are preexisting lung disease and high dosage or longterm use of amiodarone. The clinical presentations of APT are nonspecific, and main symptoms are nonproductive cough, dyspnea, weakness, weight loss, and fever. The alveolar and interstitial inflammation is frequent on the chest roentgenogram. The clinical diagnosis of APT should be considered when a patient develops the following findings: new or worsened symptoms, new abnormalities or worsening on the chest roentgenograms and a 15 percent decrease in the CO or total lung capacity. It is recommended that the benefitrisk ratio be evaluated before start of amiodarone therapy, the smallest effective dosage be used for longterm treatment, and the pulmonary function be examined at regular intervals. Once the clinical diagnosis of APT is made, the most common option is to decrease the dosage or discontinue amiodarone. Most patients’ signs and symptoms resolve after the cessation of amiodarone. The patient with severe pulmonary toxicity may be administered with shortterm corticosteroid therapy.

  • Adverse Drug Reactions Journal. 2002, 4(5): 351-351.
  • WHO信息
    . 2004, 6(1): 62-62.
  • WHO信息
    . 2003, 5(5): 352-353.
  • 安全信息
    . 2012, 14(3): 199-2.
  • Han Yuanyuan1, Liu Nannan1, Zhang Lei1, Wang Yawei2, Yan Suying2, Wang Yuqin2, Liu Fang3, Lu Jin1
    Adverse Drug Reactions Journal. 2019, 21(1): 9-14. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.003
    ObjectiveTo explore the application of failure mode and effect analysis (FMEA) in improving the management strategies of high alert medication (HAM), such as lyophilizing thrombin powder.MethodsThe study groups on medication risk and its prevention strategies of lyophilizing thrombin powder were set up in China-Japan Friendship Hospital and Xuanwu Hospital, Capital Medical University, respectively. The possible failure modes appearing in clinical application of lyophilizing thrombin powder were collected by questionnaire survey and on-the-spot investigation. The risk priority number (RPN) scores were calculated according to the score results of severity, frequency of occurrence, and likelihood of detection. Failure modes with higher RPN scores were screened out and the corresponding prevention strategies were formulated. The situations in related links before and after improvement of the strategies were analyzed comparatively. ResultsThe results from questionnaire survey and on-the-spot investigation showed a total of 37 failure modes in the links of information system, physician prescription, drug dispensing, medical order execution by nurses, and medication error reporting. Ranking the RPN scores from high to low, 15 major failure modes were screened out, including 4 modes in information system link (not setting the lyophilizing thrombin powder administration route as "oral", lack of HAM labels, lack of photo library of confusing drugs, and lack of real-time reporting program of medication errors), 2 modes in physician prescription link (existence of confusing drugs and physician prescription errors), 4 modes in drug dispensing link (lack of prescription/medication orders auditing by pharmacist, absence of the pharmacist′s double check in drug dispensing and distributing, lack of location mark of HAM and confusing drug for lyophilizing thrombin powder in the pharmacy, and no special storage area for lyophilizing thrombin powder in the pharmacy), 4 modes in the link of medical order execution by nurses (negligence in check of the administration route of lyophilizing thrombin powder, existence of nurses in ward who were unfamiliar with the drug knowledge, no double check in drug distribution, and lack of location mark of HAM and confusing drugs in the ward), and 1 mode in medication error reporting link (no real-time information sharing system for medication errors among different wards). After drawing up the improvement measures of management, no medication errors occurred during the lyophilizing thrombin powder application in the 2 hospitals. Before and after the improvements, the percentages of physicians, pharmacists and nurses knowing that lyophilizing thrombin powder package should be with a special mark were 33.3% (12/36) and 83.3% (30/36), and the percentages of those knowing the right route to report medication errors were 77.8% (28/36) and 100% (36/36), respectively, with statistically significant differences (P<0.05 for both).ConclusionsFMEA method can be used to screen the failure modes during the lyophilizing thrombin powder application effectively. The improvement of management measures for lyophilizing thrombin powder application has a positive effect on the improvement of medication safety.
  • Zhao Tianyi, Cao Ling, Wan Weiguo, Zhu Xiaoxia, Zou Hejian
    Adverse Drug Reactions Journal. 2019, 21(2): 98-101. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.005
    Febuxostat, an oral non-purine selective xanthine oxidase inhibitor, was approved firstly in Europe in 2008 for the treatment of chronic hyperuricemia in gout patients, and then in 2009 for the treatment of gout by the US FDA. In 2013, it was found by researchers that there was a possible correlation between febuxostat and cardiovascular thromboembolism events. In 2017, the US FDA issued a safety warning for febuxostat. In March 2018, the results of an eight-year study on Cardiovascular Safety of Febuxostat and Allopurinol  in Patients with Gout and Cardiovascular Comorbidities(CARES)was officially published. The study showed that febuxostat increased all-cause mortality and cardiovascular mortality in gout patients with cardiovascular disease. However, in subsequent clinical studies related to febuxostat, it was concluded that febuxostat did not increase cardiovascular risk and mortality, and could have cardio-cerebrovascular and renal protective effects in patients with hyperuricemia. Currently, the pros and cons of febuxostat on cardiovascular safety are not clear in general studies, and more clinical studies are needed, especially in the Chinese population. Thus, before treatment with febuxostat, it is necessary to carefully inquire whether the patient has a history of cardiovascular diseases, and whether there is a combination use of NSAID, antiplatelet drugs and so on. Febuxostat should be used only after a full consideration of the possible risks.
  • ADE简报
    . 1999, 1(3): 190-190.
  • ADR咨询
    . 2000, 2(3): 210-210.
  • 安全信息
    . 2007, 9(2): 150-150.
  • 不良事件
    . 2002, 4(1): 57-57.
  • 不良事件
    . 2006, 8(3): 220-220.
  • 病例报告
    . 2003, 5(2): 111-112.
  • WHO信息
    . 2002, 4(2): 135-135.
  • 不良事件
    . 2002, 4(6): 413-413.
  • Zou Yanqing, Zhang Lei
    Adverse Drug Reactions Journal. 2022, 24(11): 612-614. https://doi.org/10.3760/cma.j.cn114015-20220318-00217
    A 64-year-old female patient with left lung adenocarcinoma and cervical lymph node metastasis received chemotherapy with pemetrexed and carboplatin, and the cervical mass was significantly reduced after the first chemotherapy (5.0-cm×4.0-cm). According to the results of gene detection, icotinib 125-mg was given thrice daily orally. Four days later, the metastases of cervical lymph node rapidly increased with redness, swelling, and pain, while the symptoms such as dizziness and nausea appeared. The patient increased the dose to 250-mg orally thrice daily by herself. Two days later, neck CT showed that the left supraclavicular fossa lymph node was about 7.7-cm×6.4-cm. It was considered that the rapid increase of cervical lymph node metastasis was hyperprogression of tumor caused by icotinib. Icotinib was discontinued and chemotherapy with bevacizumab, pemetrexed, and carboplatin were given; at the same time, ametinib was given orally. Three days later, her pain was significantly reduced. Nine days later, her neck mass shrunk. Seven weeks later, the CT showed that the left supraclavicular lymph node was 4.6-cm×5.3-cm. The efficacy was evaluated as partial remission.
  • Zhang Li, Liu Dan, Zhang Lingli
    Adverse Drug Reactions Journal. 2023, 25(7): 385-388. https://doi.org/10.3760/cma.j.cn114015-20221026-00810
    Premature birth is one of the leading causes of death in children under 5 years of age. Tocolytic inhibitors can prolong pregnancy time and are one of the important treatment measures for preterm birth. However, there are still many problems in the indications, efficacy monitoring, course of treatment, and safety monitoring of drugs in clinical use. Based on the relevant guidelines for preterm birth and in combination with the clinical practice, this paper reviews some problems in the use of tocolytics in preterm labor, so as to provide help for the management of preterm birth.
  • 病例报告
    . 2002, 4(4): 259-260.
  • 不良事件
    . 2005, 7(2): 146-146.
  • 病例报告
    . 2005, 7(6): 450-451.
  • 安全信息
    . 2006, 8(4): 307-308.
  • 安全信息
    . 2009, 11(2): 146-1.
  • 安全信息
    . 2012, 14(3): 153-1.
  • Zou Yuzhen, Mei Dan, Fu Qiang, Duan Minghui, Yang Chen
    Adverse Drug Reactions Journal. 2019, 21(3): 166-175. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.003
    ObjectiveTo explore the factors influencing major adverse events in patients with hematologic neoplasms and treated with high-dose methotrexate (HDMTX) chemotherapy regimens.MethodsMedical records of all inpatients with hematologic neoplasms treated with HDMTX chemotherapy regimens in Peking Union Medical College Hospital from January 2014 to February 2016 were collected by Hospital Information System and retrospectively analyzed in combination with the adverse events surveillance files within 48 hours after HDMTX treatment, established by clinical pharmacists of hematology department. The effects of age, body mass index (BMI), methotrexate (MTX) dosage, time of intravenous infusion, liver and kidney function before administration, blood drug concentration of 20 hours after completion of one treatment cycle, and chemotherapy regimens on adverse events of ≥grade II were analyzed by single factor and multiple factor analysis.ResultsA total of 324 inpatients were entered in the study, including 179 males and 145 females with a median age of 43 (14-77) years. There were 72 inpatients  with acute lymphoblastic leukemia, 208 with non-Hodgkin lymphoma, and 44 with Langerhans cell histiocytosis. A total of 1 050 cycles of HDMTX were administered to the 324 patients. Within 48 hours after the HDMTX treatment, 159 patients had 289 times of adverse events of ≥grade II. The incidence of adverse events of ≥grade II was 49.07% and the adverse events accounted for 27.52% of the treatment cycles. Elevated serum alanine aminotransferase (ALT) was the most common adverse event [the incidence was 25.62% (83/324) and the constituent ratio was 10.38% (109/1 050)], followed by nausea and vomiting [ the incidence was 11.73% (38/324) and the constituent ratio was 5.43% (57/1 050)]and elevated serum creatinine (Scr) level [the incidence was 8.64% (28/324) and the constituent ratio was 2.76% (29/1 050)]. Multiple factor analysis showed that MTX dosage, time of intravenous infusion, and ALT level before administration were significant factors affecting ALT elevation after administration; BMI, blood drug concentration of 20 hours after completion of one treatment cycle, serum total bilirubin (TBil) and before administration were significant factors affecting Scr elevation after administration; serum TBil level before administration was the only significant factor affecting TBil elevation after administration; blood drug concentration of 20 hours after completion of one treatment cycle was the only significant factor in oral mucositis; MTX dosage, four-hour intravenous infusion regimen, and GDP/ML regimen (gemcitabine+dexamethasone+cisplatin+HDMTX+pegaspargase) were significant factors influencing adverse neuro-logical events.ConclusionsAfter HDMTX regimen chemotherapy, patients with baseline dysfunction of liver and kidney and a 24-hour intravenous infusion regimen may increase the risk of liver and kidney injury; overweight patients may have an increased risk of kidney injury; GDP/ML regimen, 4-hour intravenous infusion regimen, and higher MTX dosages may increase the risk of neurological adverse events; high blood concentration of 20 hours after completion of one treatment cycle may be a risk factor of kidney injury and oral mucositis.
  • Zhang Yunchen, Qian Xiaorong, Duan Lifang, Fei Yan
    . 2016, 18(5): 364.
    A 73-year-old female took venlafaxine hydrochloride sustained-release tablets 75 mg once daily, Shuganjieyu capsule 2 capsules once every 12 hours, candesartan cilexetil 8 mg once daily, amlodipine besylate 5 mg once daily, metoprolol succinate 47.5 mg once daily, citicoline sodium 0.2 g once every 8 hours and estazolam 1 mg per night for treating depression and hypertension. On day 8, the patient developed dizziness and fever. On day 9, she had urinary incontinence and rave, the drugs were discontinued. On day 10, the patient presented delirium and increased muscle tone. On day 11, she had bilateral mydriasis, wet skin and muscle cramps.  Drug-induced serotonin syndrome was considered. Cyproheptadine 6 mg once every 6 hours was administered orally. The patient′s mental state, functions of the autonomic nervous system and neuromuscular improved significantly after 2 days, then the dose of cyproheptadine was reduced to 4 mg once every 8 hours. After 4 days of treatment, the patient′s vital signs were stable and cyproheptadine was stopped.
  • ADR系列问答
    . 2007, 9(3): 228-228.
  • 安全信息
    . 2007, 9(6): 449-450.
  • ADR咨询
    . 2006, 8(5): 396-396.
  • 病例报告
    . 1999, 1(3): 184-184.
  • WHO信息
    . 2002, 4(3): 209-209.
  • 病例报告
    . 2006, 8(5): 383-384.
  • 不良事件
    . 2003, 5(2): 122-123.
  • WHO信息
    . 2004, 6(4): 275-275.
  • 不良事件
    . 2006, 8(1): 65-65.
  • WHO信息
    . 2003, 5(5): 354-354.
  • 病例报告
    . 2005, 7(2): 133-134.
  • 病例报告
    . 2005, 7(2): 129-130.
    A 7-year-old boy was presented with abdominal pain for 3 days, and developed swelling and pain on both knee-joints and restriction of motion after taking cefaclor 0.25g 3 times. It was considered to be associated with drug allergy. The boy had a history of allergic responses to penicillin ,so cefaclor was discontinued. Physical examination showed a lot of petechial rash on both lower limbs with symmetric distribution. He was diagnosed as dermato-joint allergic purpura and given therapy with corticosteroid etc. 3 days later, his symptoms lessened and resolved gradually.
  • ADE简报
    . 2000, 2(2): 133-133.
  • 不良事件
    . 2003, 5(6): 415-416.
  • WHO信息
    . 2002, 4(6): 417-418.
  • 抗菌药应用
    . 2004, 6(6): 393-394.
  • 国外信息
    . 2005, 7(1): 73-73.
  • 病例报告
    . 2006, 8(1): 54-55.
  • ADE简报
    . 2001, 3(1): 51-51.
  • 病例报告
    . 2006, 8(3): 213-214.
  • ADR系列问答
    . 2007, 9(4): 304-304.
  • Lu Yun
    Adverse Drug Reactions Journal. 2019, 21(4): 281-284. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.007
    Clinical benefit of anticoagulants in the treatment of thrombotic events, stroke or myocardial infarction is obvious, but their clinical risk should be weighed in each clinical setting. The improper use of anticoagulants may not only increase risk of readmission, lengthen hospitalization due to bleeding or thrombotic events, but also increase the risk of mortality. The unique pharmacokinetics and pharmacodynamics of each anticoagulant in a specific patient with different pathophysiology increases the challenge for medication safety management. Medication error is also one of the important reasons for the risk of anticoagulants in clinic. In December 2018, Joint Commission of the United States made safe use of oral anticoagulants among national patient safety goals. The standard for the safety use of anticoagulants in the certification requirement were increased from six to eight. The American Institute for Safe Medication Practices has also listed anticoagulants as high-alert medications. It calls for clinical pharmacists and multidisciplinary experts to create protocols to safe guard anticoagulant usage to improve patient safety.
  • Wen Chao, Tang Xiaoxia, Zhang Jinfeng, Duan Man, Chen Gang, Zhu Wenwen, Wang Ya
    Adverse Drug Reactions Journal. 2024, 26(7): 412-416. https://doi.org/10.3760/cma.j.cn114015‑20240410‑00241
    Objective To investigate the differences in the incidence of QT interval prolongationbetween moxifloxacin and levofloxacin in anti‑infective therapy among cardiology intensive care unit (CCU)patients, and to analyze the risk factors for QT interval prolongation. Methods The data of patients whoreceived anti‑infective treatments with moxifloxacin and levofloxacin in CCU of Xiaogan Central Hospitalfrom January 2020 to December 2022 were collected and analyzed retrospectively. The clinical characteris‑tics in the 2 groups were compared. Potential influencing factors of QT interval prolongation were analyzedusing univariate regression analysis. Variables with P<0.2 were included in a logistic regression model formultivariate analysis. The effect values were expressed as odds ratio (OR) and its 95% confidence interval(CI). Results A total of 146 patients were included in the study, with 76 patients in the moxifloxacingroup and 70 patients in the levofloxacin group. In the moxifloxacin group, 18 out of 76 patients (23.68%)experienced QT interval prolongation, while in the levofloxacin group, 6 out of 70 patients (8.57%) experi‑enced QT interval prolongation; the difference between the 2 groups was statistically significant (P=0.025).There were no statistically significant differences in other factors between the 2 groups. Univariate regression·412·药物不良反应杂志 2024 年7月第 26 卷第7期 ADRJ,July 2024, Vol. 26, No. 7analysis showed that female (OR=2.958, 95%CI: 1.144-7.647, P=0.025), myocardial infarction (OR=2.958,95%CI: 1.144-7.647, P=0.025), concomitant use of amiodarone (OR=2.569, 95%CI: 1.042-6.337, P=0.040)and escitalopram were influencing factors of QT interval prolongation. Factors with P<0.2 were entered inthe multivariate logistic regression analysis, and the results showed that female (OR=3.616, 95%CI:1.240-10.538, P=0.019), hypokalemia (OR=2.953, 95%CI: 1.263-6.905, P=0.012), and myocardial infarc‑tion (OR=3.026, 95%CI: 1.057-8.666, P=0.039) were independent risk factors for QT interval prolongation.Conclusions Moxifloxacin is associated with a higher incidence of QT interval prolongation compared tolevofloxacin. Female and patients with hypokalemia and myocardial infarction have high risks for QT intervalprolongation.
  • Zhang Xiaogang, Guo Bingrong, Liu Fei, Ma Yabin
    Adverse Drug Reactions Journal. 2019, 21(3): 229-230. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.015
    Two male patients(patient 1, 64 years old; patient 2, 63 years old)received parenteral nutrition in fasting state due to the future surgical operation for gastric space-occupying lesions and gastrointestinal bleeding, respectively. Both of them developed fatigue and cold sweat near the end of the first IV infusion of the lipid emulsion (10%)/amino acids (15) and glucose (20%) injection. Their instant blood glucose levels were 2.2 mmol/L and 2.1 mmol/L, respectively. The symptoms disappeared about 10 minutes after the immediate discontinuation of the injection and an intravenous injection of 50% glucose injection 40 ml. And their instant blood glucose levels were 5.6 mmol/L and 5.4 mmol/L, respectively. Patient 2 developed the above symptoms again near the end of the second infusion of the drug next day and his instant blood glucose level was 2.6 mmol/L. His symptoms disappeared again after the drug withdrawal and treatment of an intravenous injection of 50% glucose 40 ml and an IV infusion of 10% glucose 250 ml for about 15 minutes. Then his instant blood glucose level was 5.9 mmol/L.
  • Shen Jianghua, Zhao Simiao, Yan Suying
    ObjectiveTo explore the risk factors of acute kidney injury (AKI) in very elderly patients within 48 hours after urologic surgery.MethodsThe data of very elderly patients (≥75 years old) with detection data about renal function before and after urinary surgery in Xuanwu Hospital of Capital Medical University from January 2016 to December 2017 were retrospectively analyzed. AKI was diagnosed according to the guideline released by Kidney Disease: Improving Global Outcomes (KDIGO). The patients were divided into the AKI group and the non-AKI group. The clinical features, operation conditions, and drug use during the operation in patients in the 2 groups were compared, and the factors of P<0.05 in comparisons between groups were analyzed using binary logistic regression, and OR and its 95% confidence interval (CI) were calculated.ResultsA total of 190 patients were entered in the study. Of them, 24 patients developed AKI (the incidence of AKI was 12.6%). The differences in general conditions (sex, age, body weight, chronic diseases), serum creatinine levels, hemoglobin, serum albumin, and creatinine clearance rate before operation, rate of single use of non-steroidal anti-inflammatory drugs, and rate of single use of colloid liquid during the operation in patients in the 2 groups were not statistically significant (P>0.05). The rate of laparoscopic surgery in the AKI group [70.8%(17/24) vs. 16.3%(27/166)] was much higher than that in the non-AKI group; the operation time and the anesthesia time in the AKI group were obviously longer than those in the non-AKI Group [132(13, 203) min vs. 43(2, 328) min, 192(70, 276) min vs. 90(23, 388) min]; blood loss was significantly more than those in the non-AKI group [50 (2, 200) ml vs. 10 (0, 1 200) ml]; the drugs used in operation in the AKI group were obviously more than those in the non-AKI group [(14±4) vs. (12±4)]; the rate of combined use of NSAID and colloid in operation in the AKI group was significantly higher than that in the non-AKI group [25.0% (6/24) vs. 4.8% (8/166)]; the differences in the above-mentioned parameters between the 2 groups were statistically significant (all P<0.05). The binary logistic regression analysis showed that the type of operation (laparoscope) (OR=3.538, 95%CI: 1.047-11.962), the combined use of NSAID and colloid during the operation (OR=5.673, 95%CI: 1.312-24.536) were the independent risk factors of AKI within the 48 h after operation in very elderly patients.ConclusionsThe type of operation (Laparoscope) and the combined use of NSAID and colloid liquid are risk factors of AKI within 48 h after urologic operation in very elderly patients. In order to avoid the occurrence of AKI in very elderly patients, it is necessary to reduce the use of renal toxic drugs in operation, especially the combined use of NSAID and colloid.
  • 安全信息
    . 2007, 9(2): 151-151.
  • 病例报告
    . 2003, 5(2): 115-116.
  • WHO信息
    . 2003, 5(4): 276-276.
  • WHO信息
    . 2004, 6(4): 276-276.
  • 病例报告
    . 2004, 6(4): 257-258.
  • 滥用误用
    Huang Jina;Liu Jingb;Ding Lib;Qiao Aizhenb;Wang Hengxiangb
    . 2008, 10(1): 0-0.

    A 40yearold woman with hyperthyrosis took methimazole 10 mg thrice daily. More than 1 month later, she developed a high fever, pain around the anus. Laboratory test revealed leucopenia. Methimazole was stopped immediately. Despite of administration with metronidazole and cefuroxime for antiinfection, her symptom did not resolve. She also developed palpitation, chest distress, anorexia, and oliguria. Five days later, she was hospitalized. She had a body temperature of 40 ℃, a pulse rate of 140 beats/min, a respiratory rate of 30 breaths/min, and a BP of 60/30 mmHg. Physical examination showed sporadic petechia on her limbs, a 1.5 cm×1.5 cm perianal ulcer with purulent secretion. Her WBC count was 0.4×109/L with 0.16 neutrophils. Her haemoglobin level was 94 g/L, and her platelet count was 11×109/L. A bone marrow biopsy revealed hypoplasia with a myeloid to erythroid cell ratio of 0.5:1, few leucocytes and erythrocytes, non megacaryocyte, less platelets, lymphocytes 0.51, plasmocytes 0.13, and reticulocytes 0.345. The blood biochemical test revealed the following levels: K+ 2.9 mmol/L, Na+ 134 mmol/L, Ca 2+ 1.6 mmol/L, AST 53 U/L, ALT 207 U/L, albumin 20 g/L, and total protein 48 g/L. A thyroid function examination showed that her free T3 and free T4 levels were 38.43 pmol/L and 38.36 pmol/L, respectively, and her thyrotropin level was undetected. Despite symptomatic, supportive, and anti-infective treatment, her thyroid crisis remained so. The next morning, she suddenly developed unconsciousness. The resuscitation failed of success, and then she died.

  • 不良事件
    . 2006, 8(2): 146-147.
  • 不良事件
    . 2003, 5(5): 349-349.
  • WHO信息
    . 2003, 5(3): 208-208.
  • 病例报告
    . 2003, 5(1): 49-50.
  • 不良事件
    . 2005, 7(1): 67-68.
  • WHO信息
    . 2003, 5(6): 420-420.
  • ADE简报
    . 2000, 2(4): 266-267.
  • 病例报告
    . 2001, 3(4): 250-251.
  • 病例报告
    . 2002, 4(6): 409-410.
  • WHO信息
    . 2003, 5(6): 420-420.
  • 不良事件
    . 2003, 5(1): 57-57.
  • 不良事件
    . 2006, 8(2): 144-145.
  • 不良事件
    . 2006, 8(1): 64-64.
  • 病例报告
    . 2002, 4(3): 192-193.
  • 不良事件
    . 2004, 6(2): 129-129.
  • WHO信息
    . 2004, 6(5): 350-350.
  • 病例报告
    . 2000, 2(4): 261-262.
  • 病例报告
    . 2004, 6(6): 409-410.
  • 安全信息
    . 2006, 8(6): 468-468.
  • Qiao Yongqi, Wang Weihua, Dai Yuanyuan, XieYibin
    Adverse Drug Reactions Journal. 2019, 21(3): 213-217. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.010
    A 61-year-old male patient with gastric cancer received routine albumin supplementation after surgery, which resulted in hypoalbuminemia, increased abdominal drainage fluid and pleural effusion. Clinical pharmacists and surgeons did literature reviews and discussions, and finally reached consensuses on albumin administration of patients after gastric cancer surgery. The consensuses were as follows: (1) it is not recommended to conduct albumin supplementation routinely after gastric cancer surgery; (2) albumin is not an effective nitrogen source and it cost too much to be used as a source of postoperative nutrition or protein; (3) for patients with postoperative hypoproteinemia (<30 g/L), albumin supplementation should be used after the surgical stress response period (day 4 after the surgery) and discontinued when the serum albumin is >30 g/L; (4) for patients with peritoneal and/or pleural effusion after surgery, the nature of the effusion should be defined firstly, and albumin can be supplemented only when the transudate is determined.
  • Luo Xin, Ye Xiaofen, Cai Yingyun, Lyu Qianzhou
    Adverse Drug Reactions Journal. 2019, 21(2): 118-122. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.008
    ObjectiveTo explore risk factors of proteinuria events in bevacizumab(BEV)-treated patients with metastatic colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).MethodsThe medical records of patients with CRC and NSCLC who received BEV combined with standard chemotherapy regimen in Zhongshan Hospital Affiliated to Fudan University from September 2016 to December 2017 were collected and analyzed retrospectively.ResultsA total of 252 patients were enrolled into the study, including 166 males (65.9%) and 86 females (34.1%), aged 23-81 years with the average age of (58±11) years. One hundred and fifty-one patients were diagnosed with CRC, 101 patients were diagnosed with NSCLC, and the median cycle of the BEV treatment was 9 (1-30). The incidence of all-grade proteinuria during BEV treatment was 23.8% (60/252). The risk of proteinuria occurrence increased with aging, and patients ≥ 65 years old had the highest risk (OR=3.769, 95%CI: 2.060-6.895, P<0.001). The risk of proteinuria was also significantly increased in patients having received ≥7 cycles of BEV treatment, and the highest risk existed in patients having received ≥10 cycles of BEV treatment (OR=3.769, 95%CI: 2.060-6.895, P<0.001). The risk of BEV-associated proteinuria increased in CRC or NSCLC patients with hypertension (OR=2.189, 95%CI: 1.214-3.945, P=0.008).ConclusionsThe main risk factors of BEV-related proteinuria events in patients with CRC or NSCLC were aging ( ≥65 years old), complicated with hypertension, and receiving ≥7 cycles of BEV treatment. Urine routine and renal function monitoring should be strengthened in patients with above risk factors during their BEV treatments.
  • Zhang Cijia, Song Yanqing, Zhang Hongmei
    Adverse Drug Reactions Journal. 2024, 26(9): 535-542. https://doi.org/10.3760/cma.j.cn114015-20240124-00060
    To explore the clinical characteristics of pembrolizumab?related type 1 diabetes mellitus (T1DM). Methods The relevant databases (up to August 31, 2023) were searched and the basic information of patients, application of pembrolizumab, combination medication, the occurrence of T1DM, laboratory test results, clinical manifestation, treatment and prognosis were analyzed descriptively and statistically. Results A total of 48 patients (from 46 articles) were included in the analysis, including 27 males and 21 females, aged from 12 to 85 years with a median age of 64 years. The primary diseases were mainly lung cancer and melanoma. Thirty-eight patients had records of time from medication to diagnosis of T1DM, which was 21?660 days (a median time of 84 days). Of the 48 patients, 41 developed diabetes ketoacidosis (DKA), and 10 developed fulminant T1DM. The main clinical manifestations were polyuria, polydipsia, and thirst, and some patients had dyspnea or disturbance of consciousness. Forty?five patients had blood glucose testing records, with blood glucose levels ranging from 9.1 to 69.7?mmol/L and a median blood glucose level of 31.8?mmol/L; 43 cases had records of glycated hemoglobin testing, of which 36 cases had glycated hemoglobin ≥6.5%; 35 cases had serum C?peptide detection records, and 30 cases had serum C?peptide below the lower limit of the reference value. After being diagnosed with T1DM, 35 patients stopped pembrolizumab, 2 cases did not discontinue, and 11 cases had no relevant records; 46 patients received insulin therapy and 2 cases had no relevant records. Among the 48 patients, 2 patients′ blood glucose returned to normal, 22 patients′ blood glucose was well controlled, 1 patient′s condition deteriorated, 1 patient′s tumor progressed, 4 patients died, and 18 patients′ prognosis was not reported. Among 35 patients who stopped using pembrolizumab, 11 patients restarted immunotherapy. Conclusions The clinical manifestations of pembrolizumab?related T1DM are similar to those of common T1DM, but the incidence of DKA is higher. Half of the patients′ blood glucose can be well controlled after insulin treatment.
  • Gao Ying, Fan Jicong, Li Zhengrong
    Adverse Drug Reactions Journal. 2024, 26(11): 695-697. https://doi.org/10.3760/cma.j.cn114015-20231229-00948
    A 55-year-old female patient received Pushen capsules 4 capsules orally thrice daily due to elevated triglyceride in physical examination. Three days after taking the medicine, the patient deve- loped fatigue, anorexia, nausea, and vomiting, and 20 days later, she developed yellowish skin with itching, dark yellow urine, and clay-like stool. Laboratory tests showed alanine aminotransferase (ALT) 1 274 U/L, aspartate aminotransferase (AST) 946 U/L, alkaline phosphatase (ALP) 283 U/L, γ-glutamyltransferase (GGT) 271 U/L, total bilirubin (TBil) 126 μmol/L, direct bilirubin (DBil) 116 μmol/L. After eliminating viral hepatitis, autoimmune liver disease, fatty liver, liver cirrhosis, etc., the patient was diagnosed as having drug-induced liver injury, which was considered to be related to Pushen capsules. Pushen capsules was stopped and the treatments for liver protection and enzyme reduction were given. After 28 days, the above symptoms in the patient were significantly improved. Laboratory tests showed ALT 31 U/L, AST 38 U/L, ALP 98 U/L, GGT 110 U/L, TBil 17 μmol/L, and DBil 11 μmol/L. After consulting the literature, it was considered that the liver injury in the patient was probably related to the raw Polygonum multiflorum in Pushen capsules.
  • Zhao Jin, Chen Shidi, Liu Fang
    Adverse Drug Reactions Journal. 2024, 26(5): 299-306. https://doi.org/10.3760/cma.j.cn114015-20231109-00793
    Objective To re-evaluate the systematic evaluation and meta-analysis of safety of statins in pregnancy and provide reference for the safe use of statins in pregnant women. Methods The systematic reviews/meta-analysis on the safety of statins during pregnancy were retrieved from databases (up to October 8, 2023). The preferred reporting items for systematic reviews and meta-analyse (PRISMA) were used to evaluate the quality of the included literature, a measure tool to assess systematic reviews 2 (AMSTAR 2) scale was used to evaluate the methodological quality of the included literature, and the grading of recommendations assessment, development, and evaluation (GRADE) tool was used to evaluate the evidence quality of the included literature. The results of quantitative analysis of outcome indicators were expressed by relative risk, odds ratio, mean difference and their 95% confidence interval. Results A total of 12-systematic reviews/meta-analysis were included. There were 5, 4 and 3 documents with high quality, medium quality, and low quality, respectively, which were evaluated by PRISMA. There were 2 and 10 documents with high and very low quality, which were evaluated by AMSTAR 2 scale. The GRADE tool evidence quality evaluation results showed that among the 48 evidence bodies, 4 were of intermediate quality (8.3%), 37 were of low quality (77.1%), and 7 were of very low quality (14.6%). The re-evaluation results of systematic review/meta-analysis showed that statins exposure during pregnancy did not increase the risk of fetal birth defects and premature delivery, but increased the risk of spontaneous abortion. Pravastatin might reduce the incidence of preeclampsia with uteroplacental insufficiency and neonatal intensive care unit occupancy in patients. There were inconsistent results of statin exposure on fetal cardiac abnormalities and the risk of artificial abortion. Conclusion Statins exposure during pregnancy does not increase the risks of fetal birth defects and premature birth, but increases the risk of spontaneous abortion.
  • Yang Zhengwei, Zhou Yuanyuan, Tang Yi, Ge Feilin, Guo Yuming, Hu Huang Wanyin, Sun Chuanduo, Wang Jiabo
    Adverse Drug Reactions Journal. 2019, 21(3): 198-202. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.007
    ObjectiveTo explore the clinical characteristics and influencing factors of liver injury associated with Qubai Babuqi tablets.MethodsCase reports of liver injury associated with Qubai Babuqi tablets in the National Adverse Drug Reaction Monitoring System (ADRMS) from 2012 to 2016 and clinical information of patients with liver injury induced by Qubai Babuqi tablets, who were admitted to the Fifth Medical Center of PLA General Hospital from 2008 to 2017, were collected and retrospectively analyzed.ResultsA total of 64 patients (59 from case reports in ADRMS and 5 from the Fifth Medical Center of PLA General Hospital) with liver injury induced by Qubai Babuqi tablets were enrolled, including 32 males and 32 females, aged from 10 to 73 years with an average age of (34±13) years. Thirty-three patients (51.6%) were treated with Qubai Babuqi tablets alone, 31 patients (48.4%) had combined medication, and 3 of the 64 patients suffered from liver injury again after their remedication of Qubai Babuqi tablets. The median time from medication to liver injury was 33 (2-210) days and the median cumulative dose of Qubai Babuqi tablets was 184.5 (8.0-868.5) g. There were 35 patients (54.7%) with severe liver injury. No significant association was found between the severity of liver injury and the dose of the drug (P>0.05). But the proportion of patients with severe liver injury treated with combined medication was significantly higher than that of patients with severe liver injury treated with Qubai Babuqi tablets alone [67.7% (21/31) vs. 42.4% (14/33), χ2=4.282, P=0.042]. Among the 64 patients, the liver injury was cured in 31 patients, improved in 21 patients, did not improve in 2 patients, worsened in 2 patients (developed to hepatic encephalopathy and cirrhosis, respectively), and had unknown outcomes in 8 patients.ConclusionsAbout half of the liver injuries caused by Qubai Babuqi tablets were severe ones. The prognosis of liver injury was relatively good and it could be cured or improved in most patients. The combination of other drugs might be the influencing factor of severe liver injury caused by Qubai Babuqi tablets.
  • Xian, Zhang Pei, Wang Yulai, Lu Zhen, Sun Haiyan
    Adverse Drug Reactions Journal. 2018, 20(6): 442-443. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.009
    Two male patients (patient 1, 75 years old; patient 2, 63 years old)  underwent percutaneous coronary intervention for acute coronary syndrome. After operation, they were given ticagrelor 90 mg twice daily orally to prevent stent thrombosis. Two patients developed chest tightness and respiratory depression both about 4 hours after their first dose, with decreased respiratory rates of 9-12 and 9-13 breaths/min, respectively. In addition, patient 1 developed sleep apnea on the night after the operation. Ticagrelor was stopped and replaced by clopidogrel on the third and second day, respectively in the 2 patients. After 12 and 10 hours of ticagrelor withdrawal, the respiratory depression disappeared and did not recur at 3 and 6 days of follow-up.
  • ADR咨询
    . 2002, 4(5): 353-353.
  • 病例报告
    . 2006, 8(6): 457-458.
  • 病例报告
    . 2001, 3(2): 122-123.
  • WHO信息
    . 2001, 3(4): 265-265.
  • WHO信息
    . 2002, 4(4): 276-276.
  • 病例报告
    . 2001, 3(4): 252-253.
  • 病例报告
    . 2001, 3(4): 255-256.
  • 病例报道
    . 1999, 1(1): 62-62.
  • 病例报告
    . 2000, 2(2): 123-124.
  • 不良事件
    . 2006, 8(1): 63-64.
  • 病例报告
    . 2000, 2(3): 195-195.
  • 安全信息
    . 2006, 8(5): 394-394.
  • WHO信息
    . 2003, 5(2): 135-135.
  • ADR咨询
    . 2001, 3(1): 66-66.
  • ADR咨询
    . 2004, 6(2): 139-139.
  • ADR咨询
    . 2004, 6(1): 64-64.
  • 安全信息
    . 2007, 9(3): 225-226.
  • Liu Yi, Jing Qing, Bian Yuan, Yan Junfeng
    Adverse Drug Reactions Journal. 2019, 21(4): 273-280. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.006
    ObjectiveTo evaluate the effectiveness of self-established 33 triggers in detecting drug adverse events (ADE) in children and explore child-individual factors possibly associated with ADE.MethodsTwo hundred medical records of inpatient in Sichuan Provincial People′s Hospital, who discharged from January 1, 2017 to September 30, 2017, were sampled using the sampling method recommended by the global trigger tool white paper of U.S. Institute for Healthcare Improvement. The medical records were detected using the self-established 33 ADE triggers. If there were positive triggers, whether the children developed ADE, the classification, grading, and causal judgement of ADE, types of common drugs causing ADE in children, and the association between the individual factors in children and ADE were further analyzed.ResultsIn the 200 medical records, 200 children were involved, including 128 males and 72 females, aged from 38 minutes after birth to 18 years with the average age of 6 years. The time of hospital stay was 2 to 43 days with the average time of 10 days. Of the 200 medical records, 128 had at least 1 positive trigger, and the positive trigger rate was 64.0% (95%CI: 57%-71%). Of the 33 triggers, 29 were triggered  a total of 394 times, and 98 ADE were detected, involving 41 children. Thus the detectable rate of the triggers was 20.5%(41/200), and the positive predictive value (PPV) of the triggers in detecting ADE was 24.9% (95%CI: 20.1%-28.0%). Ninety eight ADE could be classified into 12 categories, and ADE such as abnormal white blood cell count (21.4%, 21 times), skin lesions (11.2%, 11 times), and abnormal platelet count (10.2%, 10 times) were more common. The proportion of ADE that were grading as grade 1, grade 2, and grade 3 were 39.8% (39 times), 56.1% (55 times), and 4.1% (4 times), respectively. In the causality determination, 4 (4.1%), 73 (74.5%), 19 (19.4%), 1(1.0%), and 1 (1.0%) ADE were determined as certain, probable, possible, conditional, and unassessable. Ninety eight ADE involved 18 classes (including 52 kinds) of drugs, and the frequency of drug occurrence ranged from 1 to 16 times, with a total of 143 times. Anti-tumor drugs (44.1%,63 times) appeared most frequently, and followed by antibacterial agents (23.8%,34 times). Logistic regression analysis showed that hospital stay and diagnosis of leukemia were positively correlated with the likelihood of ADE occurrence.ConclusionsThe self-established 33 triggers could effectively monitor ADE in children, despite that further improvements were necessary. The individual factors in children that might be associated with ADE were more hospitalization days and suffering from leukemia.
  • Yan Wei, Li Zongbin, Liu Xiaoling
    . 2016, 18(5): 390.
    A 94-year-old male with coronary heart disease was given nitroglycerin 10 mg by intravenous micro pump for treating his elevated blood pressure, the injection pump speed was controlled at 20 μg/min. About 6 hours after continuous administration, the patient developed blurred vision with headache and vomiting. Acute angle-closure glaucoma was diagnosed. Nitroglycerin was stopped immediately and changed oral amlodipine 5 mg once daily. He was given an intravenous infusion of 20% mannitol 125ml, 2% pilocarpine eye drops 4 times daily, oral methazolamide 25 mg twice daily. Two days later, the symptoms of headache and blurred vision improved. Four days later, the headache disappeared. Nine days later, the patient′s vision completely recoveried.
  • Ma Zhihui, Ji Ligang, Zhao Minmin
    Adverse Drug Reactions Journal. 2023, 25(12): 759-760. https://doi.org/10.3760/cma.j.cn114015-20230313-00184
    A preterm male infant suffered from continuous anuria for 20-hours, with systemic edema, serum creatinine 238-μmol/L, creatinine clearance rate 19.45-ml/min, cystatin C 5.05-mg/L, serum albumin 28.8-g/L, β2 microglobulin 6.52-mg/L, and urinary microalbumin 120.2-mg/L. He was diagnosed with acute kidney failure and hypoalbuminemia. Before his birth, his mother had been treated with sacubitril valsartan sodium tablets (50-mg, twice daily), bumetanide tablets (1-mg, once daily), clopidogrel hydrogen sulfate tablets (75-mg, once daily) and pitavastatin calcium tablets (2-mg, once daily) for 9 days due to misdiagnose. The acute kidney failure and hypoalbuminemia was considered to be associated with in utero exposure to sacubitril valsartan in the third trimester, and symptomatic and supportive treatments such as intravenous albumin supplementation, furosemide, and dopamine were given. After 56-hours of birth, his urine volume obviously increased; after 5 days, his urine volume returned to normal; after 8 days, his renal function basically returned to normal.
  • Liang Yongli, Zhang Lixin, Yang Hongxin, Tan Zhao, Guo Xiaobin, Liu Lin
    Adverse Drug Reactions Journal. 2023, 25(2): 112-114. https://doi.org/10.3760/cma.j.cn114015-20211105-01136
    A 68-year-old male patient with lung adenocarcinoma was treated with icotinib 125-mg thrice daily orally and Kanglaite soft capsules (康莱特软胶囊) 2.7 g orally 4 times daily. The patient′s serum creatinine (Scr) was 91-μmol/L before the medication. He developed foamy urine, fatigue, chest tightness, loss of appetite, and red rash on the neck and chest skin 29 days after the medication. No intervention was given and the patient received a total of 76 days of medication. Laboratory tests showed Scr 167-μmol/L, immunoglobulin A (IgA) 4-090-mg/L, urine protein 2-g/L, urinary protein 2.61 g per 24-hours, urinary red blood cells 6.8/high power field, and urine α microglobulin 66.9-mg/L. Through pathological examination, the patient was diagnosed with focal proliferative IgA nephropathy and acute renal tubule injury, which was considered to be related to icotinib. Low protein diet and the symptomatic treatments were given.After 80 days of treatment, the patient′s Scr was 189-μmol/L and urine protein was 2-g/L. After that, the patient was lost to follow-up.
  • Xie Dong, Cao Xiaocang, Yuan Hengjie, Li Zhengxiang
    Adverse Drug Reactions Journal. 2025, 27(4): 193-199. https://doi.org/10.3760/cma.j.cn114015-20240711-00558
    Objective To analyze the occurrence and influencing factors of adverse reactions in patients with inflammatory bowel disease (IBD) during the long-term treatment with vedolizumab (VDZ). Methods The study was a retrospective observational design. The study subjects were selected from patients who long-termly used VDZ to treat moderate-to-severe active IBD in Tianjin Medical University General Hospital from February 1, 2021 to December 31, 2023. Clinical data of patients were collected through the hospital system of clinical pharmacy management, including general information, IBD condition, VDZ maintenance treatment plan, combination of drugs, laboratory test results, etc. The adverse reactions of VDZ were screened and their clinical manifestations, severity, intervention and outcomes were analyzed descriptively. The patients were divided into 2 groups according to whether VDZ adverse reactions occurred, and the differences in clinical data between them were compared; the influencing factors of adverse reactions were analyzed by multivariate logistic regression method. Results A total of 142 patients were included in the study, including 81 males and 61 females, aged (37.6±6.4) years with a range from 18 to 57 years. There were 103 patients (72.5%) developed VDZ adverse reactions, which mainly involved skin (52 patients, account for 50.5%), digestive system (33 patients, account for 32.0%) and respiratory system (18 patients, account for 17.5%). All 103 patients did not stop VDZ treatment, and the adverse reaction symptoms disappeared or were relieved after symptomatic treatments. Compared with patients without VDZ adverse reactions, the age of patients with VDZ adverse reactions were higher [(39.5±5.4) years vs. (32.4±6.7) years], and the proportions of patients with chronic relapsing clinical type [65.0%(67/103) vs. 41.0%(16/39)], severe disease activity [60.2%(62/103) vs. 33.3%(13/39)], combined drug use [67.0%(69/103) vs. 46.2%(18/39)], and injecting VDZ once every 4 weeks during maintenance treatment [27.2%(28/103) vs. 10.3%(4/39)] in the group were larger, with statistical significance (all P<0.05). Multivariate logistic regression analysis showed that the chronic relapsing clinical type [odds ratio (OR)=1.012, 95% confidence interval (CI): 1.001-1.028, P=0.002], severe disease activity (OR=1.096, 95%CI: 1.010-1.158, P=0.040), combination drugs (OR=1.035, 95%CI: 1.003-1.122, P=0.041), VDZ maintenance therapy injection interval of 4 weeks (OR=1.014, 95%CI: 1.002-1.113, P=0.005) were the risk factors for VDZ adverse reactions. Conclusions Among IBD patients receiving long-term treatment of VDZ, the incidence of adverse reactions of VDZ was 72.5%, mainly involving skin, digestive system and respiratory system. Symptomatic treatments could be given, and the prognosis was good. Patients with chronic relapsing clinical type, severe disease activity, com- bination therapy, and shorter VDZ maintenance injection interval were at higher risk of adverse reactions.
  • Ma Zhihui, Fu Dong, Ji Ligang
    Adverse Drug Reactions Journal. 2025, 27(2): 107-114. https://doi.org/10.3760/cma.j.cn114015-20240428-00292
    Objective To explore the adverse effects of maternal exposure to angiotensin receptor blockers (ARBs) during the second and third trimesters of pregnancy on the fetus/neonate. Methods Rele- vant databases at home and abroad were searched (up to April 2024), and case reports of ARB exposure during the second and third trimesters of pregnancy were collected. Data such as patient age, ARB drugs exposed to and the gestational age, concomitant drugs, maternal amniotic fluid examination, and fetal/neonatal outcomes were extracted from the literature. Descriptive statistical analysis was conducted on the information of ARB exposure during pregnancy. Results A total of 37 case reports were included, describing the outcomes of 55 fetuses/neonates (including a pair of twins) exposed to ARBs in utero during the second and third trimesters of pregnancy of 54 pregnant women. Six kinds of ARBs were involved in the 54 pregnant women, including valsartan (31.5%, in 17 women), candesartan (25.9%, in 14 women), losartan (22.2%, in 12 women), olmesartan (11.1%, in 6 women), telmisartan (5.6%, in 3 women), and irbesartan (3.7%, in 2 women); 49 women (90.7%) took above ARBs continuously form pre-pregnancy or the first trimester of pregnancy to the second and third trimesters of pregnancy, which were mostly prescribed by non-obstetricians (internal medicine or general practice). In the 54 pregnant women, 46 had amniotic fluid examination during pregnancy, of which 45 (97.8%) had oligohydramnios or absence of amniotic fluid; 4 voluntarily induced labor to terminate pregnancy, and 50 reported the natural outcome of pregnancy and had 51 fetuses/newborns, 15 (29.4%) of which died in utero or within 1 week after birth, and 36 (70.6%) of which were discharged alive. Among the newborns, 81.3% (39/48) were premature infants, and 74.4% (32/43) were low birth weight infants. In the 55 fetuses/newborns, 48 (87.3%) had varying degrees of disease and developmental defects. The most commonly involved organ or system was kidney [72.7% (40/55)], and the major pathological change was renal tubular dysplasia; the following injury was lung/respiratory diseases and dysplasia with an incidence of [41.8% (23/55)], which was the main cause of fetal/neonatal death. Subsequently, abnormal development of skull/brain and limbs/hands and feet, abnormal circulatory system, abnormal coagulation, retinopathy, etc. have also been reported. Conclusion ARBs exposure during the second and third trimesters of pregnancy poses significant risks to the fetus/neonate, often leading to developmental defects of renal tubular, lung, skull/brain, and limbs, and even death.
  • Hong Lei, Lin Zhiqiang, Peng Xuefeng, Lin Yihui
    Adverse Drug Reactions Journal. 2019, 21(3): 237-238. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.019
    A 41-year-old female patient with type 2 diabetes mellitus changed her medication without the doctor′s advice to empagliflozin 25 mg once daily from oral metformin, acarbose and repaglinide, which had regularly been taken for 1 year (during that period, her fasting blood glucose was about 9.0 mmol/L, and she had no obvious symptoms of thirsty, polydipsia, and polyuria). On day 13 after taking empagliflozin, she developed symptoms of thirsty, polydipsia, and polyuria, which aggravated gradually. Laboratory tests showed arterial blood pH 7.28, bicarbonate 17 mmol/L, carbon dioxide-combining power 13 mmol/L, anion gap 20 mmol/L, fasting blood glucose 9.2 mmol/L, blood ketone 4.8 mmol/L, and urine ketone (++++). She was diagnosed with diabetic ketoacidosis. Empagliflozin was stopped. Hypoglycemic agent insulin and symptomatic supportive treatments including potassium supplementation and fluid replacement were given. Two days later, the above symptoms of thirsty, polydipsia, and polyuria improved, and her blood ketone decreased to 1.6 mmol/L. Nine days later, the above symptoms of thirsty, polydipsia, and polyuria disappeared.
  • Xu Ying, Yang Yan, Li Zhihu, Zhang Lianxing, Fan Chunling
    Adverse Drug Reactions Journal. 2019, 21(6): 447-448. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.011
    A 47-year-old male patient received XELOX regimen [an IV infusion of oxaliplatin 200 mg on day 1, oral capecitabine 3 500 mg on day 1 to 14 (1 500 mg at 8: 00 and 2 000 mg at 20: 00), the treatment course was 21 days] after radical resection of colon cancer. During the 1st to 5th chemotherapy cycles, amaurosis fugax occurred 20 to 30 minutes after finishing the IV infusion of oxaliplatin each time. With the increase of the number of chemotherapy cycles, the number of amaurosis fugax decreased (5, 3, 1, 1, 1 times, respectively) and the duration each time also decreased. when amaurosis fugax appeared each time mecobalamin 0.5 mg was given orally thrice daily for 3 days. By the end of chemotherapy, no amaurosis recurred. The amaurosis did not recur after IV infusions of oxaliplatin in the 6th, 7th, and 8th chemotherapy cycles.
  • Zhang Shiliang
    Adverse Drug Reactions Journal. 2019, 21(5): 381-382. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.013
    A 44-year-old female patient took by herself compound Ganmaoling granules 10 g thrice daily orally for a cold. Two days later, the patient developed yellowish sclera and urine, and then the drug was stopped. The next day, her urine color became darker, her skin turned yellow, and she developed fatigue, nausea, vomiting, and etc. On day 4 of onset, laboratory tests showed alanine aminotransferase (ALT) 1 276 U/L, aspartate aminotransferase (AST) 1 042 U/L, total bilirubin (TBil) 208.2 μmol/L, direct bilirubin (DBil) 165.0 μmol/L, and negative hepatitis B related serological markers. On day 6 of onset, the possibility of patients suffering from hepatitis A, C, D and E was excluded by laboratory tests results. Her liver injury was considered to be related to the compound Ganmaoling granules. IV infusions of compound glycyrrhizin injection, ademetionine 1,4-butanedisulfonate for injection, and reduced glutathione for injection and dicyclol tablets orally were given. After treatments, her symptoms gradually improved, and basically disappeared on  day 23 after hospitalization. A reexamination of liver function showed ALT 15 U/L, AST 29 U/L, TBil 59.6 μmol/L, and DBil 47.9 μmol/L.
  • ADR系列问答
    . 2007, 9(3): 228-228.
  • ADR咨询
    . 2003, 5(1): 63-63.
  • ADR咨询
    . 2000, 2(3): 210-210.
  • 不良事件
    . 2004, 6(1): 57-58.
  • 病例报告
    . 2001, 3(3): 198-199.
  • WHO信息
    . 2002, 4(1): 60-60.
  • 不良事件
    . 2004, 6(6): 420-420.
  • 病例报告
    . 2006, 8(3): 215-216.
  • 不良事件
    . 2006, 8(3): 222-223.
  • 病例报告
    . 2006, 8(5): 381-382.
  • 不良事件
    . 2004, 6(5): 346-347.
  • 病例报告
    . 2001, 3(1): 45-46.
  • 病例报告
    . 2005, 7(5): 373-374.
  • 病例报告
    . 2005, 7(5): 368-369.
  • 病例报告
    . 2005, 7(4): 297-298.
  • 病例报告
    . 2005, 7(4): 299-300.
  • ADE简报
    . 2001, 3(4): 259-260.
  • 不良事件
    . 2005, 7(3): 226-227.
  • WHO信息
    . 2001, 3(4): 265-266.
  • WHO信息
    . 2004, 6(2): 138-138.
  • 不良事件
    . 2003, 5(1): 54-54.
  • 不良事件
    . 2006, 8(1): 62-63.
  • 不良事件
    . 2006, 8(3): 224-225.
  • 病例报告
    . 2004, 6(2): 119-120.
  • 安全信息
    . 2006, 8(5): 395-395.
  • 安全信息
    . 2006, 8(6): 467-467.
  • WHO信息
    . 2004, 6(4): 276-276.
  • ADR咨询
    . 2003, 5(1): 63-63.
  • ADR咨询
    . 2002, 4(3): 210-210.
  • ADE简报
    . 2000, 2(1): 58-58.
  • He Sumei, Jiang Yiguo, Cheng Wenxiu, Feng Lin, Sun Xiaoming
    Adverse Drug Reactions Journal. 2019, 21(6): 467-468. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.021
    A 59-year-old female patient received targeted therapy with apatinib mesylate tablets (500 mg orally, once daily) for neuroendocrine tumor-derived intraperitoneal metastasis. On the 3rd day of treatment, the patient suddenly developed chest distress and shortness of breath, her blood pressure was 170/102 mmHg, and heart rate was 43 beats/min. The electrocardiogram showed sinus bradycardia and prolonged QT interval from 412 ms before treatment to 502 ms. Her N-terminal probrain natriuretic peptide (NT-proBNP) was 2 945 ng/L. Apatinib was withdrawn and symptomatic treatments such as oxygen inhalation, antihypertension, and myocardial nutrition were given. Two days later, her symptoms gradually relieved, blood pressure returned to normal, and NT-proBNP decreased to 291 ng/L. After the symptoms disappeared, the patient took apatinib (125 mg once daily) again. Seven days later, dizziness and hypertension occurred again and her NT-proBNP was 782 ng/L. After apatinib withdrawal and symptomatic treatments, the patient′s symptoms improved.
  • Huang Yan, Zhou Suqin, Song Xia, Yao Yuan
    Adverse Drug Reactions Journal. 2023, 25(10): 635-637. https://doi.org/10.3760/cma.j.cn114015-20220901-00802
    An 86-year-old male patient with acute exacerbation of chronic heart failure developed diuretic resistance due to long-term use of diuretics, and was added tolvaptan 3.75-mg once daily orally, with significant diuretic effect. The next day, the dose was increased to 7.5-mg once daily orally. After taking medication, the patient′s urine volume increased and the symptoms of heart failure were improved. On the third day, the patient developed frequent dry mouth, thirst, transient restlessness, and convulsion of extremities. Laboratory tests showed pH 7.51, partial pressure of blood oxygen (PaO2) 67.4-mmHg, standard bicarbonate concentration (SB) 28.4-mmol/L, actual bicarbonate concentration (AB) 28.5-mmol/L, blood potassium 3.0-mmol/L, blood sodium 143-mmol/L, and blood chlorine 104-mmol/L. It was considered that the metabolic alkalosis and respiratory acidosis were caused by tolvaptan. Tolvaptan was stopped and arginine injection, 0.9 % sodium chloride, potassium supplementation, and other symptomatic treatments were given, and the patient′s water drinking was not restricted. On the day of tolvaptan discontinuation, the patient′s dry mouth and thirst were significantly reduced, his mental state was improved, with no convulsion of extremities, and lower limb and facial edema subsided. After 1 day of drug withdrawal, the laboratory tests showed pH 7.49, SB 31.1-mmol/L, AB 31.4-mmol/L, and blood potassium 3.6-mmol/L. After 3 days of drug withdrawal, the patient developed drowsiness, poor mental state, and weakened breathing compared to before, which was considered that the patient suffered from metabolic alkalosis combined with respiratory acidosis and secondary type II respiratory failure. Intravenous pumping of nikethamide was given. After 5 days of drug withdrawal, the patient′s 24-hour urine volume was 3-285-ml, and the levels of AB, SB, and pH slightly decreased. However, the patient′s condition was not improved significantly. After 13 days of drug withdrawal, symptomatic and supportive treatments such as tracheal intubation and ventilation assistance were given, but the patient′s condition continue to worsen.
  • Adverse Drug Reactions Journal. 2024, 26(6): 384-384. https://doi.org/10.3760/cma.j.cn114015-20240611-00435
  • Li Guangping, Wu Jiangtao, Wang Qi, Cui Bo, Wang Xu, Lu Lu, Ou Tongwen
    Adverse Drug Reactions Journal. 2022, 24(4): 213-215. https://doi.org/10.3760/cma.j.cn114015-20210510-00548
    A 38-year-old female patient with uraemia received tacrolimus 1-mg orally twice daily after kidney transplantation. The serum trough concentration of tacrolimus was 9.8-μg/L on the 15th day. On the 17th day, the patient developed abdominal pain, nausea, and vomiting. The abdominal CT showed that the volume of pancreas increased, the edge was irregular, and obvious exudation appeared around the pancreas and in the abdominal cavity. Laboratory tests showed blood amylase 430-U/L and lipase 231-U/L. The acute pancreatitis related to tacrolimus was considered. Tacrolimus was stopped and replaced by cyclosporine A 100-mg orally twice daily. Meanwhile, symptomatic and supportive treatments such as fasting, gastrointestinal decompression, lipid-lowering, acid inhibition, anti-infection, and parenteral nutrition were given. Three days later, the above symptoms were relieved. Nineteen days later, laboratory tests showed blood amylase 173-U/L and lipase 51-U/L; abdominal CT showed that the outline of the pancreas was clearer than before, and the exudation around was significantly reduced.
  • 病例报告
    . 2000, 2(1): 49-49.
  • ADR咨询
    . 2000, 2(1): 34-34.
  • 安全信息
    . 2011, 13(5): 330-1.
  • 不良事件
    . 2003, 5(2): 123-124.
  • 安全信息
    . 2006, 8(4): 307-307.
  • 病例报告
    . 2006, 8(4): 306-306.
  • 病例报告
    Gao Jinjuan;Ji Sha;Huang Qiaoping
    . 2008, 10(1): 0-0.

    A 5yearold girl with bronchial pneumonia received budesonide nebulising suspension 2 ml twice daily, oral ketotifen 0.5 mg and procaterol 12.5 μg twice daily, montelukast sodium chewable tablets 5 mg once daily for treating cough. The next day, she developed left knee pain. Montelukast sodium chewable tablets were withdrawn, and other drugs were continued. Knee pain resolved after two days. Two weeks later, treatment with budesonide aerosol 200 μg twice daily and montelukast sodium chewable tablets 5 mg once daily was readministered. Knee pain with muscle stiffness of the legs occurred again 3 days later. Montelukast was discontinued again. Seven days later, knee pain was relieved. Another 2 days later, his symptoms resolved.

  • ADE简报
    . 2000, 2(3): 199-199.
  • 不良事件
    . 2003, 5(3): 200-201.
  • ADE简报
    . 2001, 3(2): 126-126.
  • WHO信息
    . 2001, 3(4): 266-266.
  • 不良事件
    . 2005, 7(3): 228-228.
  • 不良事件
    . 2004, 6(3): 196-197.
  • 不良事件
    . 2005, 7(3): 227-227.
  • 国外信息
    . 2005, 7(1): 73-73.
  • 病例报告
    . 2002, 4(6): 407-408.
  • WHO信息
    . 2001, 3(4): 268-268.
  • WHO信息
    . 2004, 6(2): 137-137.
  • 不良事件
    . 2005, 7(4): 309-309.
  • WHO信息
    . 2003, 5(1): 61-61.
  • ADE简报
    . 2000, 2(3): 198-198.
  • 病例报告
    . 2006, 8(4): 304-305.
  • 病例报告
    . 2006, 8(4): 295-296.
  • 系列问答
    . 2008, 10(3): 223-1.
  • 病例报告
    . 2006, 8(5): 375-376.
  • 病例报告
    . 2006, 8(5): 384-385.
  • WHO信息
    . 2004, 6(6): 422-422.
  • WHO信息
    . 2004, 6(4): 275-275.
  • WHO信息
    . 2002, 4(1): 60-60.
  • 安全信息
    . 2012, 14(3): 201-1.
  • ADR咨询
    . 2000, 2(4): 277-277.
  • ADR咨询
    . 2000, 2(2): 83-83.
  • 安全信息
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  • Hong Liangliang, Qian Xiaorong, Zhang Tao
    Adverse Drug Reactions Journal. 2019, 21(1): 71-72. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.018
    A 4 years and 10 months old boy received an intravenous infusion of vancomycin for suppurative arthritis of left hip joint. Before treatment, the laboratory tests showed white blood cell count (WBC) 8.11×109/L and neutrophil count (NEUT) 4.06×109/L. On day 11 of treatment, the symptoms improved markedly and the laboratory tests showed WBC 6.28×109/L and NEUT 1.28 ×109/L. On day 12, the boy developed skin rash. On day 13, vancomycin was discontinued and changed to oral linezolid tablets 0.15 g thrice daily, with no other combination drugs. After taking linezolid tablets, the NEUT decreased to 0.52×109/L, increased to 1.64×109/L, and dropped again to 0.25×109/L respectively on day 2, day 5, and day 13. Neutrophil deficiency induced by linezolid tablets was considered. Then linezolid tablets were discontinued. Five days later, the NEUT increased to 1.65×109/L.
  • Shi Xiaoping, Lyu Qianzhou, Wang Ting, Xu Qing
    Adverse Drug Reactions Journal. 2018, 20(6): 460-462. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.018
    Two male patients (patient 1, 46 years old; patient 2, 41 years old), who had underwent liver transplantation, received polymyxin B 75 mg (patient 1 175 mg and patient 2 150 mg at the first dose) by IV infusion twice daily because of postoperative infection by Klebsiella pneumoniae. They developed hyperpigmentation on the skin of the head and neck without any change on the rest of the body respectively on day 13 and 15 of the medication. Patient 1 continued to use the drug due to uncontrolled infection. The skin color of the head and neck continued to deepen and then appeared to be dark brown when the patient died of multiple organ failure on day 29 of the medication. Patient 2 stopped using polymyxin B because of the improvement of the condition on day 31 of the medication when the skin color of the head and neck was dark brown. At 4 months of follow-up, his skin color of the head and neck was significantly lighter, but not returned to its original appearance.
  • Liu Huibo, Pei Liping, Ding Yuhong, Zhang Hongmei
    Adverse Drug Reactions Journal. 2022, 24(4): 206-208. https://doi.org/肝素, 低分子量; 皮肤疾病, 水疱大疱性; 尿激酶
    A 70-year-old female patient was treated with low molecular weight heparin calcium, levocarnitine, recombinant human erythropoietin, and ceftazidime due to end-stage renal disease, renal anemia, catheter-related infection, etc. At the same time, ceftazidime, urokinase, and low molecular weight heparin calcium was pumped into the long-term indwelling catheter to dredge the catheter because of suspected local bacterial capsule formation and long-term indwelling catheter blockage. On the 4th day of treatments, the patient developed mild pruritus. On the 5th day, it was found that the skin of her left upper limb and lower abdomen was scattered with dark red blood blisters ranging from 0.01 to 2-cm, with approximate hemispherical or irregular shape, clear boundary, and slight pain in touch. Nikolsky sign was negative. Bullous haemorrhagic dermatosis was diagnosed and it was considered to be caused by the combination use of urokinase and low molecular weight heparin calcium. The 2 drugs were stopped and heparin-free hemodialysis was given. The skin symptoms were relieved gradually. After 9 days of drug withdrawal, the blood blisters dried up and scabbed. At a 2-week follow-up, all blood scabs fell off by themselves.
  • Xu Qian, Wu Wei, Wang Chunhui
    Adverse Drug Reactions Journal. 2024, 26(4): 248-250. https://doi.org/10.3760/cma.j.cn114015-20230809-00590
    A 65-year-old male patient received immunotherapy combined with targeted therapy (nivolumab 360-mg intravenously on day 1 and anlotinib 12-mg orally once daily from day 1 to day 14, 21 days as a cycle) for tumor recurrence after radical gastrectomy for gastric cancer. Hypothyroidism and hand-foot syndrome occurred during the 7th cycle of treatment, then anlotinib was discontinued, and levothyroxine sodium 50-μg once daily was given. On the 9th cycle of nivolumab treatment, the patient developed unexplained fatigue, and laboratory tests showed that adrenocorticotropic hormone (ACTH) (8: 00-am) 19.5-ng/L, cortisol (8: 00-am) 191-nmol/L, thyrotropin 19.3 mU/L, and free thyroxine 11.5-pmol/L. The dosage of levothyroxine sodium increased to 100-μg/d orally once daily. After that, the levels of ACTH and cortisol in the patient continued to decline, which was considered to be immune-related hypophysitis caused by nivolumab. Nivolumab was stopped and cortisol replacement therapy was given. Eleven days later, the patient′s fatigue symptom was alleviated. At 1 year follow-up, laboratory tests showed that the level of cortisol gradually returned to normal, but ACTH was still less than 1.5-ng/L, suggesting that the damage of pituitary gland in the patient caused by nivolumab was irreversible.
  • Adverse Drug Reactions Journal. 2024, 26(10): 587-587. https://doi.org/10.1001/jama.2024.7741
      包括《美国医学会杂志》(JAMA)在内的许多医学期刊,都将因果关系的表述限制使用于随机临床试验的报告。而由于成本、随访时间或伦理等方面的限制,有些医疗干预或政策干预要通过试验来回答是否有效是不可行的。医学、流行病学、生物统计学等许多学科正在探讨观察性研究提供因果效应证据的潜力。实际上观察性研究的方法已经取得了进步,当强有力的假设成立时,产生具有因果解释的结果是有可能的。
      作者认为不应禁止在观察性研究的报告中使用因果性的表述。根据跨学科的因果推理的大量文献,作者提出了在观察性研究报告中使用因果性表述前提的框架,即应讨论:(1)什么是因果问题;(2)什么样的量化程度(如果知道)能够解释为因果关系;(3)什么样的研究设计;(4)提出了什么样的因果假设;(5)在原则上和实践中,如何使用观察到的数据来说明是因果关系;(6)对因果解释的分析是否站得住脚。
      作者认为采用这样的框架在研究报告中探讨因果关系的问题,可以强化对研究目标的理解,有助于对研究假设、设计和分析的评估,有利于更清晰更准确地解释研究结果,有望促进作者、审稿人、编辑和读者之间更好的沟通。
      作者提醒提出该框架并不意味着观察性研究都值得进行因果性的解释。有些以因果关系解释的目的开始的观察性研究,可能会自证因果推理是不可能实施的。此外,许多重要的描述性和预测性的研究问题并不需要含因果观念的观察性研究提供的数据来回答。
  • Xiang Longyun, Qiu Yanlong, Chen Tao
    Adverse Drug Reactions Journal. 2024, 26(1): 59-61. https://doi.org/10.3760/cma.j.cn114015-20221207-01130
    A 40-year-old female patient took Rukuaixiao granules 10 g thrice daily orally by herself due to breast pain and nodules. After about 1 and a half months of medication, the patient developed intermittent right upper abdominal distension and pain, dark yellow urine, accompanied by fatigue, aversion to greasy food, nausea, vomiting, etc. After 2 and a half months of medication, the above symptoms worsened. Laboratory tests showed total bilirubin (TBil) 98.8-mmol/L, direct bilirubin (DBil) 51.5-mmol/L, alanine aminotransferase(ALT) 962-U/L, aspartate aminotransferase (AST) 1-213-U/L,γ-Glutamyltransferase(GGT) 196-U/L, and alkaline phosphatase (ALP) 124-U/L. The liver injury caused by Rukuaixiao granules were considered. Then the drug was discontinued and treatments such as glutathione, hepatocyte growth- promoting factor, tiopronin, Jiangmeiling(降酶灵), silymarin, and ursodeoxycholic acid were given. After 10 days of treatments, the patient′s symptoms were gradually improved; after 13 days, the patient′s digestive symptoms disappeared. Laboratory tests showed TBil 20.5-mmol/L, DBil 6.2-mmol/L, ALT 43-U/L, AST 58-U/L, GGT 53-U/L, and ALP 60-U/L. Glutathione, hepatocyte growth-promoting factor, and tiopronin were discontinued, and Jiangmeiling, silymarin, and ursodeoxycholic acid were continued to be taken for 2 weeks. Six weeks later, the patient′s liver function returned to normal. The patient′s liver injury was most likely related to the Fructus toosendan in Rukuaixiao granules.
  • Qin Qi, Tang Liangliang, Zhang Zhiren
    Adverse Drug Reactions Journal. 2023, 25(8): 491-496. https://doi.org/10.3760/cma.j.cn114015-20221010-00927
    Ponatinib is a multi-target tyrosine kinase inhibitor (TKI) indicated as second-line therapy for chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. It is the first BCR-ABL kinase inhibitor that targets ABL-T315I, and is effective for patients who have received multiple treatments or lack sensitivity to first or second-generation TKIs. However, the cardiovascular toxicities of ponatinib are frequent and serious. The common cardiovascular adverse events of ponatinib are arterial occlusive events, hypertension, myocardial infarction, etc. The mechanisms of these events might be related to platelet dysfunction, vascular endothelial dysfunction, and myocardial injury. Once adverse cardiovascular events occur in the treatment of ponatinib, dose reduction and even therapy discontinuation are common measures, which might hinder the tumor therapeutic effect in patients. Intervention measures can be formulated according to the "ABCDE" method to reduce the risk of cardiovascular toxicity of ponatinib.
  • Yan Yilong, Zhang Yi'nan, Zhao Zhigang
    Adverse Drug Reactions Journal. 2025, 27(4): 207-211. https://doi.org/10.3760/cma.j.cn114015-20240620-00473
    Objective To mine the risk signals of adverse events (AEs) in mavacamten treatment for hypertrophic cardiomyopathy, and provide reference for safe use of the drug in clinic. Methods AE reports on mavacamten from June 2022 to June 2024 were collected by searching US Food and Drug Adminis- tration Adverse Event Reporting System (FAERS) database. AEs were classified and standardized according to the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities version 26.1. Reporting odds ratio (ROR) method and comprehensive standard method of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) were used to mine the AE risk signals. An AE that simultaneously met the criteria of ≥3 reports, lower limit of the 95% confidence interval (CI) of ROR >1, PRR ≥2, and χ2 ≥4 was defined as a risk signal. Descriptive statistical analysis on signals was performed. Results A total of 1 041 AE reports were collected, involving 47 PTs and 12 SOCs. The top 10 risk signals based on the number of AE reports were dyspnea, dizziness, fatigue, atrial fibrillation, cardiac failure, palpitation, nasopharyngitis, chest pain, COVID-19, and weight increased. Except dizziness and heart failure, above AEs were not recorded in the label. The top 10 risks in signal intensity were acquired left ventricle outflow tract obstruction, transvalvular pressure gradient increased, cardiovascular symptom, echocardiogram abnormal, hypervolaemia, left ventricular failure, ejection fraction decreased, coronavirus infection, brain fog, and atrial fibrillation. Except cardiovascular symptom, left ventricular failure, and ejection fraction decreased, above AEs were not recorded in the label. Conclusions The AE risk signals of mavacamten in the treatment for hypertrophic cardiomyopathy recorded in the label are mainly heart failure and ejection fraction decreased. Clinicians and pharmacists should also be vigilant against risk signals not recorded in the lakel, such as atrial fibrillation, fatigue, nasopharyngitis, coronavirus infection, and brain fog, etc.
  • Liang Cuilyu, Zhang Yin
    Adverse Drug Reactions Journal. 2024, 26(1): 38-43. https://doi.org/10.3760/cma.j.cn11401-20230306-00155
    Objective To mine the risk signals of thromboembolism and hepatotoxicity related to thrombopoietin receptor agonists (TPO-RAs) and provide references for safe use of these drugs in clinic.  Methods Adverse event (AE) reports on eltrombopag, romiplostim, and avatrombopag from October 2009 to September 2023 were collected by searching US FDA Adverse Event Reporting System database. AEs were classified and standardized according to the systematic organ class (SOC) and preferred terms (PT) of Medical Dictionary for Regulatory Activities version 25.0. The AE risk signals of thromboembolism and hepatotoxicity related to the 3 TPO-RAs were mined using reporting odds ratio (ROR) method. An AE with reports ≥3 and the lower limit of the 95% confidence interval of ROR >1 was defined as a risk signal. Results The number of AE reports with eltrombopag, romiplostim and avatrombopag as the primary suspect drugs were 25-215, 18-762, and 1-204, respectively. Fifty-two, 51, and 9 PTs of thromboembolic events (TEEs) related to eltrombopag, romiplostim and avatrombopag were mined, respectively. The top 5 PTs in the signal strength of eltrombopag were renal embolism, portal vein thrombosis, splenic thrombosis, splenic vein thrombosis and hepatic artery thrombosis. The top 5 PTs in the signal strength of romiplostim were embolism arterial, cerebral vascular occlusion, vertebral artery occlusion, portal vein thrombosis, and thrombosis mesenteric vessel. The top 5 PTs in the signal strength of avatrombopag were renal vein thrombosis, portal vein thrombosis, cerebral venous sinus thrombosis, embolism, and deep vein thrombosis. In addition, 25, 14 and 4 PTs of hepatotoxicity related to eltrombopag, romiplostim, and avatrombopag were mined, respectively. The top 5 PTs in the signal strength of eltrombopag were portal vein dilatation, portal vein thrombosis, hepatic artery thrombosis, indirect bilirubin increase, and chronic hepatic failure. The top 5 PTs in the signal strength of romiplostim were portal vein thrombosis, chronic hepatic failure, alcoholic liver disease, hepatic haematoma, and hepatic cirrhosis. The PTs in the signal strength of avatrombopag were portal vein thrombosis, liver function test abnormality, hepatic function abnormality, and hepatic enzyme increase. A total of 24 PTs not recorded in drug labels of the 3 TPO-RAs were mined. The top 5 PTs in the signal strength were portal vein dilatation, chronic hepatic failure, liver function test abnormality, alcoholic liver disease, and ocular icterus. Conclusions TEEs and hepatotoxicity are common adverse reactions of the 3 TPO-RAs. The coagulation function and liver function of patients should be monitored before and after application of TPO-RAs. It should be alert for the adverse reactions not recorded in the drug labels.
  • Adverse Drug Reactions Journal. 2024, 26(2): 117-117. https://doi.org/10.1002/pds.5719.
    50多年来,自发报告系统(SRS)是识别产品上市后非预期作用的唯一选择。SRS的高灵敏度使其特别适合于识别罕见的药物使用或疫苗接种相关的结局。SRS在识别安全信号方面的重要作用预计将继续存在,但自发报告的处理需要大量的资源。一项单个组织的研究报告了每份自发报告获取数据的中位时间为69-min,而GSK估计处理每份自发报告的平均花费为33美元。这些估计还不包括多个组织处理同一份报告或遵照法规与其他组织分享报告所产生的费用。而在全球范围内,数据库中数以百万计的自发报告中,有许多报告与旧的(甚至已停产的)产品或已知的不良反应有关。
    作者根据美国FDA不良事件报告系统数据库公众数据面板中截至2022年6月30日的数据进行分析发现,在美国99.8%(2076/2080)的罗非昔布相关急性心肌梗死的自发报告是在将增加心血管事件风险添加到说明书后提交的;93.2%(1938/2080)是在该药撤市后提交的。自2016年哨点系统(sentinel system)在美国全面投入使用以来,所有提交给FAERS的心肌梗死报告中,有40.3%(13277/32919)涉及说明书已标记的不良事件(AE)。
    作者认为,药物警戒领域应该考虑停止或取代价值很小的活动,以更加聚焦于患者安全。AE一旦已知,收集、组织和共享自发AE报告的工作不会带来额外的公共卫生价值。考虑到世界各地药物警戒基于真实世界数据的策略,哨点计划(sentinel initiative)应该更适合监测已知的AE。
    作者建议应该根据哨点系统和其他观测数据库网络系统的进展,重新考虑SRS对已知不良反应的作用,哨点系统的方式可能更适当,可以进行发生率估计。
  • Chen Yang, Zhang Kezhou, Zhu Qi, Wang Jun
    Adverse Drug Reactions Journal. 2024, 26(7): 442-443. https://doi.org/10.3760/cma.j.cn114015‑20231220‑00918
    A 37‑year‑old male patient with plaque psoriasis received treatment with secukinumab(injection of secukinumab 300 mg at weeks 0, 1, 2, 3, and 4, once per week, followed by 1 dose/4 weeks).After 3 months of treatment, the psoriasis rash completely subsided, but the patient had depigmented patchesof varying sizes on the dark brown pigment imprints on the lower back, and hands, with an area did notexceeding the original pigment imprint range. Under the Wood lamp, the lesions appeared as clearly definedand bright blue white patches, diagnosed as vitiligo. It was considered that vitiligo possibly was caused bysecukinumab. The patient had no pain, itching or other symptoms in the lesions and was not treated. After 2months of continued treatment with secukinumab, no significant changes were observed in the white patches.
  • Wang Daimei, Zhao Eryi, Zhong Jingbo, Han Fangxuan, Lyu Xiuping
    Adverse Drug Reactions Journal. 2018, 20(6): 463-464. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.019
    A 58-year-old male patient received aspirin enteric-coated tablets 200 mg and rosuvastatin calcium 10 mg once daily by mouth, IV infusions of butylphthalide and sodium chloride injection 100 ml (containing butylphthalide 25 mg and sodium chloride 0.9 g) twice daily and troxorutin brain protein hydrolysate 10 ml once daily for acute ischemic stroke. Seven days later, laboratory tests showed blood urea 6.9 mmol/L, serum creatinine (Scr) 131 μmol/L, and blood cystatin C 1.54 mg/L. Kidney injury induced by butylphthalide and sodium chloride injection was considered. Butylphthalide and sodium chloride injection was stopped but the other drugs as well as Xueshuantong for injection (注射用血栓通) and Corbrin capsule (百令胶囊) were given. Laboratory tests showed blood urea 6.2 mmol/L, Scr 104 μmol/L, and blood cystatin C 1.05 mg/L 6 days later and then blood urea 5.9 mmol/L, Scr 101 μmol/L, and blood cystatin C 1.00 mg 2 months later.
  • Adverse Drug Reactions Journal. 2019, 21(2): 160. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.023
  • ADR咨询
    . 2000, 2(4): 277-277.
  • ADR咨询
    . 2002, 4(3): 210-210.
  • ADE简报
    . 1999, 1(3): 191-191.
  • WHO信息
    . 2003, 5(4): 277-277.
  • WHO信息
    . 2004, 6(3): 203-203.
  • ADE简报
    . 2001, 3(1): 53-53.
  • 病例报告
    . 2006, 8(6): 447-448.
  • 病例报告
    . 2004, 6(2): 121-122.
  • 安全信息
    . 2008, 10(2): 152-1.
  • WHO信息
    . 2002, 4(3): 207-208.
  • WHO信息
    . 2003, 5(1): 61-62.
  • WHO信息
    . 2003, 5(3): 207-207.
  • 病例报告
    . 2002, 4(5): 339-340.
  • 不良事件
    . 2005, 7(2): 145-145.
  • WHO信息
    . 2002, 4(3): 208-208.
  • 病例报告
    . 2001, 3(3): 196-197.
  • ADR咨询
    . 2003, 5(1): 63-63.
  • 安全信息
    . 2007, 9(6): 448-449.
  • ADR系列问答
    . 2007, 9(1): 74-74.
  • 安全信息
    . 2007, 9(2): 151-151.
  • Shan Wenya, Jiang Saiping, Liu Fang, Lu Xiaoyang
    Adverse Drug Reactions Journal. 2019, 21(5): 334-338. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.005
    ObjectiveTo analyze the risks of high alert drug concentrated potassium chloride injection in clinical application using failure mode and effect analysis (FMEA) method and make the relevant prevention measures.MethodsA study team was established in the First Affiliated Hospital, Zhejiang University. The risk points in the application process of concentrated potassium chloride injection through literature search, questionnaires, and on-the-spot investigations were collected. Severity(S), frequency of occurrence(O), and likelihood of detection(D) of the risks related to these failure modes were scored and the risk priority numbers (RPN) were determined. The failure modes with RPN >10.0 or their severity up to 5.0 were screened out and the corresponding prevention strategies were formulated.ResultsFive risk points were collected through literature search; 10 risk points were obtained through questionnaires, including 3 from physicians, 3 from pharmacists, and 4 from nurses; and 5 risk points were obtained through on-the-spot investigations. Sixteen risk points with RPN > 10.0 or severity up to 5.0 were further screened from the above links, including 3 from information system links, 2 from drug storage links, 4 from doctor prescription links, 4 from pharmacist dispensing links, and 3 from nurse administration links. According to the selected risk points, 22 prevention strategies were formulated. The prevention measures for the above 5 links were 4, 4, 6, 5, and 3, respectively, including 11 mandatory strategies, 9 recommended strategies, and 2 conditional strategies.ConclusionThe risk points of concentrated potassium chloride injection application can be screened using FMEA method, which is helpful to formulate the preventive strategies for medication errors related to the drug.
  • Chen Zhe, Cong Minghua, Yang Jun, Song Chenxin, Li Xinyan, Li Guohui
  • Wu Qi, Gao Xiaoxing, Zhang Lu, Duan Minghui
    . 2016, 18(5): 379.
    A 26-year-old female with relapsed of acute lymphoblastic leukemia received  chemotherapy regimen of  high-dose methotrexate (7.5 g) plus vindesine and pegaspargase. In order to ensure the drug concentration in central nervous system,  methotrexate (1.5 g) was given by means of  intravenous drip within 30 minutes. About 5 minutes after the beginning of  intravenous drip, the patient developed severe cough,  cough up yellow foamy phlegm, vomiting (gastric content), and severe wheezing. Her pulse oxygen saturation declined rapidly from 0.94 to 0.60. The result of auscultation of the lungs revealed coarse crackles. She was diagnosed as acute pulmonary edema. Methotrexate was stopped. The patient was ordered to keep orthopnea position. She received symptomatic treatment which including oxygen uptake, intravenous injection of furosemide 20 mg for diuresis, dexamethasone 5 mg for antianaphylaxis. About 30 minutes later, her symptoms of  wheezing, cough,  expectoration and vomiting were relieved obviously, pulse oxygen saturation increased to 0.95. The result of chest CT scan on the next day showed multi-ground glass patchy opacities. The diagnosis of  pulmonary edema was corroborated. Two days later, the patient′s symptoms of  cough and wheezing disappeared completely, coarse crackles in her both lung was disappeared. Her pulse oxygen saturation returned to 0.98. Four days later, the result of chest CT scan showed that the lungs′ changes of  CT scan were returned to normal,
  • ADR咨询
    . 2002, 4(6): 421-421.
  • ADR咨询
    . 2000, 2(1): 34-34.
  • ADE简报
    . 2001, 3(3): 201-201.
  • 病例报告
    . 2005, 7(4): 292-293.
  • WHO信息
    . 2003, 5(4): 277-277.
  • 病例报告
    . 2004, 6(6): 412-413.
  • 药物安全动态
    . 2006, 8(3): 231-232.
  • WHO信息
    . 2002, 4(4): 276-276.
  • WHO信息
    . 2003, 5(6): 419-420.
  • WHO信息
    . 2002, 4(2): 136-136.
  • WHO信息
    . 2001, 3(4): 268-268.
  • WHO信息
    . 2004, 6(2): 137-137.
  • 病例报告
    . 2000, 2(3): 196-196.
  • Li Siyan, Zhang Qingxia, Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs
    Adverse Drug Reactions Journal. 2025, 27(1): 17-24. https://doi.org/10.3760/cma.j.cn114015-20240715-00570
    Objective To explore the risk factors of severe medication errors (ME) of tranexamic acid injection (TXAI), and put forward prevention suggestions. Methods TXAI-related ME reports in the National Monitoring Network for Clinical Safe Medication (Monitoring Network) and medical literature databases at home and abroad were searched, and case reports of TXAI-related ME were collected; China Judgements Online and PKULAW database were searched, and TXAI-related judicial cases judged to be responsible by the hospital were collected. The retrieval time of all data was up to May 1, 2024. The severity grade, occurrence link and place, and the trigger person of TXAI-related ME reported in the Monitoring Network were retrospectively analyzed. The year of report, country of occurrence, clinical application, error content, and occurrence place of the collected severe ME cases, and the clinical characteristics of patient injury, patient outcome and the ME grading were retrospectively analyzed. Results From September 22, 2012 to May 1, 2024, the Monitoring Network received a total of 138 TXAI-related ME reports, and there was an increasing trend in the number of reports year by year. Among 138 cases of ME, 79 (57.3%) occurred in the drug dispensing and distribution link; 58 (42.0%) occurred in the prescription/doctor′s order prescribing and delivery link and mainly involved easily mixed drugs and drug overdose, of which 1 (1.7%) was a severe ME (grade E); 1 (0.7%) occurred in the drug administration link, and iodohexol was mistakenly injected as TXAI into the patient′s joint cavity. A total of 29 severe ME reports related to TXAI were collected. Of them, 24 (82.8%) were due to incorrect administration routes (22 were confused with anesthetics and 2 were confused with injection catheters, all resulting in incorrect intrathecal injections) and 5 (17.2%) were due to prescription errors (3 were overdosed, 1 was used for high-risk thrombosis patient, and 1 was treated with combination use of hemocoagulase for high-risk thrombosis patient); 23 (79.3%) occurred in the operating rooms, and 6 (20.7%) occurred in the wards. The 24 patients involved in incorrect intrathecal injections of TXAI mainly developed severe pain, neurotoxicity (status epilepticus) and/or cardiotoxicity (arrhythmia and ventricular fibrillation), of which 11 (45.8%) died and 2 (8.3%) had sequelae of limb muscle weakness. Among the 5 patients with prescription errors, 4 developed severe thrombotic disease, resulting in 2 deaths and 2 cerebrovascular-related sequelae, and the other one developed palpitation, shortness of breath, nausea and vomiting. Among the 29-severe ME cases, 2 (6.9%) were grade E, 3 (10.3%) were grade F, 4 (13.8%) were grade G, 7 (24.2%) were grade H, and 13 (44.8%) were grade I. Conclusions TXAI-related ME mainly involved easily mixed drugs and prescription errors. The severe ME main occurred in the operating room and mainly due to incorrect intrathecal injection, leading to fatal neurological and cardiac toxicity in patients.
  • Zheng Li, Song Jiangman, Guo Dan, Zhang Yatong
    Adverse Drug Reactions Journal. 2024, 26(11): 652-657. https://doi.org/10.3760/cma.j.cn114015⁃20240505⁃00299
    Objective To explore the status and problems of safety recommendations in clinical practice guidelines and expert consensuses (guidelines/consensuses) on Chinese patent medicine (CPM) in China. Methods Wanfang Med Online, CNKI, VIP, China Biology Medicine Database, Chinese Medical Journal Full Text Database, and the websites of Medlive, and China Association of Chinese Medicine were searched, and the guidelines/consensuses related to CPM were collected. The basic information, types, subject areas, evidence rating methods, safety reporting items, safety recommendation levels, and evidence sources of these guidelines/consensuses were extracted and analyzed by descriptive statistics. Results A total of 138 guidelines/consensuses were included in the analysis, including 19 guidelines and 119 consensuses. The first guideline/consensus on CPM was published in 2004. Five, 3, 9, 15, 29, 32, 29, and 11 guidelines/consensuses were published respectively from 2016 to 2023. From 2020 to 2023, 101 guidelines/consensuses were published, which was 2.73 times the total number of those published in the past 16 years.(101/37). Among the 138 guidelines/consensuses, 59 (42.75%) were "disease?based" and 79 (57.25%) were "drug?based". The top 5 institutions in terms of the number of publications were National Administration of Traditional Chinese Medicine, China Association of Chinese Medicine, Institute of Basic Research in Clinical Medicine of China Academy of Chinese Medical Sciences, Chinese Association of Integrative Medicine, and Chinese Medical Association, of which National Administration of Traditional Chinese Medicine issued 19 guidelines. However, the issuing units of 26 guidelines/consensuses were medical colleges/medical institutions and the issuing units of 8 guildlines/consensuses were not clearly stated. Among the 138 guidelines/consensuses, 18 (13.04%) did not describe the safety of drugs and 120 (86.96%) described. Among the 120 guidelines/consensuses, none of the safety recommendations were graded according to The Grading of Recommendations Assessment, Development and Evaluation, and only 32.50% (39/120) of the evidence sources contained randomized controlled trials. A proportion of 50.72% (70/138) in 138 guidelines/consensuses did not report the funding situation, and 37.68% (52/138) did not disclose the conflict of interest. Conclusions In recent years, the number of guidelines/consensuses on CPM has increased significantly in China, but the issuing agencies of some of them had poor authority. Most of the guidelines/consensuses are "drug-based", the descriptions of safety are insufficient, the evidence level is low, and there may be some bias.
  • 病例报告
    . 2005, 7(6): 453-454.
  • WHO信息
    . 2004, 6(2): 137-137.
  • 不良事件
    . 2005, 7(5): 387-387.
  • 不良事件
    . 2005, 7(5): 391-392.
  • ADE简报
    . 2000, 2(4): 267-267.
  • 病例报告
    . 2000, 2(2): 122-123.
  • WHO信息
    . 2002, 4(4): 275-275.
  • 不良事件
    . 2002, 4(3): 199-199.
  • 系列问答
    . 2009, 11(4): 300-2.
  • 病例报告
    . 2006, 8(6): 451-452.
  • 中药不良反应
    . 2006, 8(5): 390-391.
  • WHO信息
    . 2001, 3(1): 57-57.
  • WHO信息
    . 2001, 3(3): 206-207.
  • ADR咨询
    . 2000, 2(3): 210-210.
  • ADR咨询
    . 2001, 3(4): 278-278.
  • ADE简报
    . 2000, 2(1): 58-58.
  • ADE简报
    . 2000, 2(1): 59-59.
  • Xu Lei, Wang Junhui, Zhao Li, Liu Feiyu, Zhang Lei, Wang Yinglin, Sun Haiyan
    Adverse Drug Reactions Journal. 2019, 21(2): 140-141. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.013
    An 11-year-old boy received IV infusions of azithromycin for injection 0.5 g for 3 hours once daily and cefotiam for injection 1.0 g thrice daily for bronchopneumonia. The boy did not complain of hearing abnormality before medication. Tinnitus appeared about 2 hours after the beginning of the first and second IV infusions of azithromycin and disappeared about 2 and 3 hours later, respectively. Additionally, his hearing decreased after the second dose of azithromycin (the pure-tone audiometry showed that the average hearing thresholds of his right and left ears were 43 and 47 dB, respectively). Sensorineural deafness was diagnosed. The boy developed persistent tinnitus and further hearing loss 1 hour after the beginning of the third IV infusion of azithromycin (the average hearing thresholds of the right and left ears were 51 and 60 dB, respectively). Azithromycin was discontinued, cefotiam was continued, and extract of ginkgo biloba leaves tablets were given orally (1 tablet twice daily). On day 2 after azithromycin discontinuation, his tinnitus improved. On day 5, his tinnitus disappeared and hearing improved (the average hearing thresholds of the right and left ears were 42 and 49 dB, respectively). On day 40, his hearing improved further (the average hearing thresholds of his right and left ears were 32 and 36 dB, respectively).
  • Liu Zongyan, Chen Chaoyang, Xie Xianting, Zhang Guiqing, Zhou Ying, Cui Yimin
    Adverse Drug Reactions Journal. 2019, 21(3): 225-226. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.013
    A young girls took irregularly Vitamin D2 tablets  (0.25 mg/tablet, each tablet contains 10 000 IU vitamin D2) purchased by her parents at a pharmacy since she was 1.5 years old. The girl took 1 tablet at a time, once to thrice daily, occasionally missing. Five months later, she developed polydipsia and polyuria. She drank more than 2 000 ml water every day, urinated once every 0.5-1 hour, and urinated more than 5 times every night. Her maximum daily urine volume could reach 3 400 ml, and her urine was transparent as clear water. Three weeks after the symptoms appeared, laboratory tests in another hospital showed that blood calcium was 4.34 mmol/L, blood phosphorus was 2.65 mmol/L, and 24-hours urine calcium was 8.0 mmol. Vitamin D poisoning was suspected and her parents were asked to stop feeding the girl vitamin D2 tablets. Rehydration, diuretics and other treatments were given. After 3 days, her blood calcium decreased to 3.60 mmol/L. After 6 days, she was transferred to Peking University First Hospital, where she continued to receive rehydration and symptomatic treatments with a low calcium and phosphorus diet. And after 8 days, the blood calcium was 2.47 mmol/L and 24-hours urine calcium was 2.7 mmol. Her symptoms of polydipsia and polyuria improved and she was discharged. Telephone follow-up 1 month after discharge, the girl′s polydipsia and polyuria disappeared and her urine examination was normal.
  • Li Yuan
    Adverse Drug Reactions Journal. 2019, 21(5): 372-376. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.011
    Sodium-glucose co-transporter 2 (SGLT2) inhibitors are new antihyperglycemics, which reduce blood glucose by selectively inhibiting the activity of SGLT2 and reducing the reabsorption of glucose in proximal convoluted tubules. One of the major safety problems of SGLT-2 inhibitors is the possibility of urogenital system infections due to increased local glucose levels in the urogenital tract. The incidences of urinary tract infections in patients with dapagliflozin, canagliflozin, empagliflozin, and ertugliflozin treatments were 4.4%-11.4%, 4.9%-8.3%, 5.0%-15.6%, and 3.2%-7.2%, respectively; and the incidences of genital infections were 6.2%-13.0%, 6.2%-13.4%, 2.3%-9.5%, and 2.1%-10.0%, respectively. The main manifestations of urinary tract infection are urethritis and cystitis and conventional anti-infection therapy are effective. Candida is the most common pathogen in reproductive system infections. The clinical features of reproductive system infections in most females are vulvovaginitis, in fewer females are pelvic inflammation and genital warts, which occur mostly within the first 4 months of medication; while the clinical features in most males are balanitis and balanoposthitis, in fewer males are epididymo-orchitis and genital warts, which mostly occur in the first year of medication. Urogenital system infections in most patients cure quickly after treatments, rarely leading to withdrawal of SGLT2 inhibitors. However, severe reproductive system infections (such as Fournier′s gangrene) caused by SGLT2 inhibitors have also been reported. During the treatment with SGLT2 inhibitors, it is necessary to strengthen patient monitoring and the education on related knowledge so as to minimize the inducing factors of urogenital system infections. Once an infection occurs, it should be treated timely.
  • 不良事件
    . 2004, 6(1): 56-56.
  • ADR咨询
    . 2000, 2(4): 277-277.
  • ADR咨询
    . 2004, 6(4): 277-277.
  • ADR咨询
    . 2006, 8(2): 154-154.
  • WHO信息
    . 2002, 4(1): 61-61.
  • 不良事件
    . 2004, 6(4): 271-272.
  • WHO信息
    . 2001, 3(1): 56-56.
  • 不良事件
    . 2004, 6(6): 419-420.
  • 不良事件
    . 2002, 4(5): 347-348.
  • WHO信息
    . 2002, 4(4): 275-276.
  • Yuan Ting, Weng Wenhan, Zhao Yang, Yu Zhiying
    Adverse Drug Reactions Journal. 2024, 26(4): 254-256. https://doi.org/10.3760/cma.j.cn114015-20230630-00486
    A 52-year-old male patient with small cell lung cancer developed symptoms of systemic skin redness, edema, and blisters of varying sizes in multiple parts of the body (neck, chest, and feet) 10 days after receiving chemotherapy with TC regimen (albumin paclitaxel and carboplatin) combined with serplulimab for immunotherapy. It is suspected to be toxic epidermal necrolysis caused by serplulimab. After discontinuing serplulimab and receiving symptomatic treatments such as methylprednisolone, loratadine, ebastine, and adjuvant topical mucosal protection for 10 days, the dermatitis basically subsided and the ruptured blisters were scabby. The patient switched to anlotinib and did not receive immunotherapy again.
  • Wang Li, Ren Xiuli, Zhang Mei, Lin Zehui, Zhang Xusheng, Lu Cuicui
    Adverse Drug Reactions Journal. 2025, 27(4): 200-206. https://doi.org/10.3760/cma.j.cn114015-20240611-00436
    Objective To explore the clinical features of nivolumab-induced Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN). Methods Relevant databases at home and abroad (as of December 31, 2023) were searched to collect case reports of nivolumab-induced SJS/TEN, and the demographic characteristics, nivolumab application, combination drugs, clinical manifestations, intervention measures, and outcomes were extracted and analyzed descriptively and statistically. Results A total of 27 case reports were included and 29 patients were enrolled in the study, including 18 males and 11 females. The age ranged from 45 to 86 years, with an average age of 67 years. The primary diseases were mainly melanoma, stomach cancer, and lung cancer. Twelve patients had records of nivolumab administration, and the dosage was within the recommended range in the labels; 13 patients had records of combination drugs, mainly other antineoplastic drugs, hypoglycemic drugs, antihypertensive drugs, lipid-regulating drugs, etc. The time from using nivolumab to the diagnosis of SJS/TEN was 7 d to 3 years, and 20 patients were <8 weeks. The clinical manifestations were mainly diffuse erythema, flaky skin peeling and erosion, mucosal involvement, etc. Sixteen patients had skin biopsy records, all of which met the histopathological characteristics of SJS/TEN. After the diagnosis of SJS/TEN, 17 patients discontinued nivolumab and received symptomatic treatments, of which 15 patients had improved skin symptoms, one patient had worsened skin symptoms, and one patient had no record of skin outcome; 12 patients had no record of whether or not discontinuing nivolumab, of which 8 patients had improved skin symptoms, 2 patients had worsened skin symptoms, one patient had no record of skin outcome, and one had no record of prognosis. One patient rechallenged nivolumab, severe SJS/TEN recurred. Thirteen of 29 patients died. Of them, 1 died due to cardiac arrest, 4 due to worsened skin rash, and 8 due to primary disease progression. Conclusions SJS/TEN caused by nivolumab mostly occurs within 8 weeks of treatment, and the clinical manifestations were similar to those caused by other drugs. The mortality rate of nivolumab-induced SJS/TEN is high, and skin rash could be improved after withdrawal of nivolumab and symptomatic treatments.
  • Adverse Drug Reactions Journal. 2024, 26(7): 445-445. https://doi.org/10.3760/cma.j.cn114015‑20240611‑00427
  • 病例报告
    . 2001, 3(4): 257-257.
  • 病例报告
    . 2002, 4(5): 337-338.
  • WHO信息
    . 2002, 4(2): 136-137.
  • WHO信息
    . 2004, 6(2): 138-138.
  • 病例报告
    . 2000, 2(3): 194-194.
  • WHO信息
    . 2003, 5(1): 58-58.
    ;王大猷;时颖华
  • 病例报告
    . 2006, 8(4): 292-293.
  • WHO信息
    . 2003, 5(2): 134-134.
  • WHO信息
    . 2002, 4(1): 62-62.
  • 不良事件
    . 2002, 4(1): 57-57.
  • ADR咨询
    . 2006, 8(3): 234-234.
  • ADE简报
    . 2000, 2(1): 61-61.
  • ADR系列问答
    . 2009, 11(5): 379-1.
  • Shao Rong, Tao Tiantian
    Adverse Drug Reactions Journal. 2019, 21(5): 377-380. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.012
    In order to establish a more powerful legal guarantee for drug administration, the Drug Administration Law of the People′s Republic of China (PRC) was revised systematically for the second time in August 2019. In this revision, taking public health as its foothold, a scientific and strict legal system was established to guarantee the medication safety and legitimate right of the public by ensuring the quality of drugs, which is of great significance to promote the scientific, modern, and legal process of drug safety management in China. In this paper, taking medication safety of patient as starting point, through analysis on the general principles and core clauses of the law, the legal framework, sympathetic drug use, marketing authorization holder system, legal liability for illegal acts, Good Manufacture Practice of Medical Products (GMP) dynamic inspection system, and new definition of counterfeit drugs in the context of the new drug administration law were interpreted.
  • Adverse Drug Reactions Journal. 2019, 21(5): 321-321. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.001
  • Dong Shujie1, Cao Ke2, Zhai Suodi1
    Adverse Drug Reactions Journal. 2019, 21(1): 55-56. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.010
    A 61-year-old female patient took cefadroxil tablets 0.5 g twice daily herself due to fever after blepharorrhaphy in her right eye. Her temperature returned to normal, but the medication was not discontinued and 2 weeks later, the patient developed skin rash on her limbs with severe itching, and fever (39 ℃). Then cefadroxil tablets were stopped but her symptoms were gradually aggravated, and then facial swelling appeared 5 days later. On the seventh day of onset, she was admitted to the hospital, with white blood cell count 25×109/L, percentage of eosinophils 0.29, eosinophil count 7.4×109/L, and normal liver and kidney function, myocardial enzymes, and electrocardiogram. Antiallergic and symptomatic treatments were given after the admission. On day 4 of admission, the patient developed dizziness and general fatigue. Her blood pressure was 96/61 mmHg and her heart rate was 110 beats per minute. The electrocardiogram showed multilead ST segment elevations and the echocardiography revealed a small amount of pericardial effusion. Laboratory tests showed that the cardiac troponin T (cTnT) was 1.52 μg/L, creatine kinase (CK) was 236 U/L, CK-MB was 63 U/L, and N-terminal pro-brain natriuretic peptide (NT-proBNP) was 9 708 ng/L. The patient was diagnosed with drug hypersensitivity syndrome complicated with acute myocarditis and pericarditis. Intravenous infusion of high dose methylprednisolone (500 mg/d), human immunoglobulin (40 g/d), and myocardial nutrition treatments were given. On day 5 of admission, the patient was transferred to the cardiovascular care unit (CCU), when her blood pressure was 80/50 mmHg, CK was 498 U/L, CK-MB was 98 U/L, cTnT was 5.33μg/L, and left ventricular ejection fraction was 55%. However, the patient′ myocarditis and pericarditis progressed rapidly. On day 3 in the CCU, the laboratory tests showed CK 1 252 U/L, CK-MB 231 U/L, cTnT 4.57 μg/L, NT-proBNP 17 979 ng/L, and left ventricular ejection fraction 10%, which then decreased to 5% on day 6. Finally, the patient died on day 9 in the CCU.
  • Zhao Yanyan, Niu Lingling, Li Yuanyuan
    Adverse Drug Reactions Journal. 2019, 21(4): 293-294. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.011
    A 54-year-old female patient received Yuanhu Zhitong dropping pills 30 pills thrice daily for pelvic inflammatory-related abdominal pain. Six months after medication, the patient developed anorexia, nausea, dark brown urine, and skin pruritus.After taking Hugan tablets(护肝片) orally for 2 weeks, the symptoms did not improve. The patient stopped using Yuanhu Zhitong dropping pills by himself. On day 7 of drug withdrawal, the laboratory tests showed alanine aminotransferase(ALT) 679 U/L, aspartate aminotransferase (AST) 698 U/L, total bilirubin (TBil) 66.5 μmol/L, and direct bilirubin (DBil) 51.8 μmol/L. Liver injury induced by Yuanhu Zhitong dropping pills was considered. Hepatoprotection treatments were given. Seven days later, the laboratory tests showed ALT 278 U/L, AST 317 U/L, TBil 150.8 μmol/L, and DBil 115.4 μmol/L. Twenty-five days later, the patient did not complain of discomfort, above symptoms disappeared, and the laboratory tests showed ALT 54 U/L, AST 49 U/L, TBil 44.5 μmol/L, and DBil 39.0 μmol/L. At 4 months of follow-up,  the patient had normal liver function.
  • Nie Xin, Zhang Ping, Cheng Gang, Shi Hong, Li Lin
    Adverse Drug Reactions Journal. 2019, 21(4): 305-306. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.017
    A 70-year-old female patient received chemotherapy regimen of pemetrexed combined with cisplatin for metastatic non-small-cell lung cancer. After 2 cycles of chemotherapy, the tumor partly relieved, but the patient developed grade II leukopenia and serum creatinine elevation. Renal injury was considered to be caused by cisplatin. Therefore, cisplatin was discontinued in the third cycle and pemetrexed monotherapy was given. On day 10 of the chemotherapy, the patient developed fever and laboratory tests revealed pancytopenia, white blood cell count (WBC) 1.1×109/L, neutrophil count 0.54×109/L, platelet count (PLT) 63×109/L, hemoglobin (Hb) 72 g/L, and red blood cell count (RBC) 2.23×1012/L. The patient received symptomatic and supportive treatments such as platelet and erythrocyte suspension infusion, and granulocyte colony stimulating factor subcutaneous injection, but her complete blood count continued to decline, with WBC 0.2×109/L, neutrophil 0.13×109/L, PLT 0×109/L, Hb 59 g/L, and RBC 1.88×1012/L. Ⅳ myelosuppression induced by pemetrexed was diagnosed. Calcium folinate was given for rescue therapy (the first dose was 100 mg/m2, then 50 mg/m2 every 6 hours for 4 days). After 23 days of calcium folinate treatment, the laboratory tests showed WBC 6.8×109/L, neutrophil 3.84×109/L, PLT 169×109/L, Hb 95 g/L, and RBC 2.99×1012/L.
  • Peng Jing, Ma Jie, Cao Xiaofu, Liu Zhen, Zhao Yanyan, Wang Hui, Chen Jing, Zhang Zhengjun
    Adverse Drug Reactions Journal. 2019, 21(6): 435-440. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.007
    Patients with diabetes mellitus are at high risk for osteoporotic and fractures. Some hypoglycemic drugs may increase the risk of fracture in diabetic patients. At present, the commonly used new hypoglycemic agents include incretin mimetic drugs and sodium-glucose co-transporter protein 2 (SGLT2) inhibitors. The incretin mimetic drugs include dipeptidyl peptidase 4 (DPP4) inhibitors and glucagon-like peptide (GLP) 1 receptor agonists. It was found in clinical studies that GLP1 receptor agonist liraglutide and DPP4 inhibitor alogliptin may reduce the risk of fracture events in patients with type 2 diabetes mellitus, while GLP1 receptor agonist exenatide may increase the risk of fracture when its daily dose is more than 22.5 μg. SGLT2 inhibitors can inhibit the reabsorption of sodium and glucose in renal tubules and increase the reabsorption of phosphate. The increase of blood phosphorus can indirectly promote bone absorption, which would lead to osteoporosis and increase the risk of fracture. However, there was no evidence in clinical studies that other SGLT2 inhibitors except canagliflozin may be associated with the increase of fracture risk.
  • Ning Jing, Yang Zhentao, Liu Fuquan, Li Li′an
    A 36 year-old female patient with stage II invasive mole (low-risk type) received single drug chemotherapy with 5-fluorouracil (5-Fu). The 5-Fu (30 mg/kg) was given by an intravenous infusion from the first day to the eighth day in each 22-day chemotherapy cycle. The patient developed dysarthria and dysphagia during the 5-Fu treatment on day 6 in the third cycle. The result of head magnetic resonance imaging (MRI) showed extensive white matter injury. 5-Fu was immediately discontinued and nutritional supportive treatments to brain cells were given. Five hours later, the above symptoms disappeared. Twenty-four hours later, the above symptoms recurred and above-mentioned supportive treatments were given again. Three hours after the treatment, the above symptoms disappeared again. Then the chemotherapy regimen was changed to be an IV infusion of actinomycin D (0.4 mg/d) from the first day to the fifth day in each 19-day cycle. During the treatment, the patient′s vital signs were stable and her pronunciation and ingurgitation functions were normal.
  • Adverse Drug Reactions Journal. 2021, 23(1): 1-1. https://doi.org/10.3760/cma.j.cn114015-20200113-00059
  • ADR咨询
    . 2001, 3(1): 66-66.
  • 不良事件
    . 2004, 6(1): 58-58.
  • WHO信息
    . 2002, 4(1): 62-62.
  • 病例报告
    . 2000, 2(4): 257-258.
  • ADE简报
    . 2001, 3(1): 52-53.
  • ADE简报
    . 2000, 2(4): 265-266.
  • 不良事件
    . 2003, 5(4): 272-272.
  • 病例报告
    . 2003, 5(2): 114-115.
  • 不良事件
    . 2003, 5(1): 56-57.
  • ADE简报
    . 2000, 2(3): 201-201.
  • ADE简报
    . 2001, 3(2): 127-127.
  • WHO信息
    . 2002, 4(4): 276-277.
  • 病例报告
    . 2002, 4(2): 126-126.
  • WHO信息
    . 2002, 4(4): 275-275.
  • WHO信息
    . 2004, 6(6): 423-423.
  • ADE简报
    . 2000, 2(2): 131-131.
  • Shi Huahui, Ji Chunmei
    Adverse Drug Reactions Journal. 2025, 27(1): 25-29. https://doi.org/10.3760/cma.j.cn114015-20240531-00407
    Objective To mine the risk signals of adverse events (AE) of satralizumab for treatment of neuromyelitis optica spectrum disorder (NMOSD) and provide reference for safe use of the drug in clinic. Methods AE reports on satralizumab from the 1st quarter of 2020 to the 4th quarter of 2023 were collected by searching US Food and Drug Administration Adverse Event Reporting System (FAERS) database. AEs were classified and standardized according to the preferred term (PT) and system organ class (SOC) of Medical Dictionary for Regulatory Activities version 26.1. Reporting odds radio (ROR) method and Bayesian confidence progressive neural network (BCPNN) method were used to mine the AE risk signals. An AE with ≥3 reports, lower limit of the 95% confidence interval (CI) of ROR >1, and the information component (IC) of BCPNN method minus 2 times of standard deviation (IC-2SD) >0 were defined as a risk signal. Descriptive analysis on the signals was performed. Results A total of 526 AE reports were collected, 39 risk signals (PT) were mined by ROR and BCPNN methods, involving 13 SOCs. Among the 39 PTs, 11 were adverse reactions recorded in the label, including blood triglycerides increased, hepatic function abnormal, cellulitis, and etc. Twenty-eight PTs were not recorded in the label, 11 of which involved infections and infestations. The top 5 PTs in signal intensity were atypical mycobacterium infection, pyelonephritis, compression fracture, spinal compression fractures, and lymphocyte count decreased. The top 5 PTs in number of reports were urinary tract infection, pneumonia, corona virus disease 2019, sepsis, and herpes zoster. Conclusion In addition to the blood triglycerides increased, hepatic function abnormal, cellulitis, and other AEs recorded in the label, NMOSD treatment with satralizumab may also cause atypical mycobacterial infection, pyelonephri- tis, compression fracture and other AEs not recorded in the label, which clinical physicians should be vigilant.
  • Peng Jin′e, Liu Hui, Xia Jianying, Wang Shuo, Zhan Hanqiu
    Adverse Drug Reactions Journal. 2024, 26(5): 275-279. https://doi.org/10.3760/cma.j.cn114015-20231009-00722
    Objective To explore the effect of nirmatrelvir/ritonavir (Paxlovid) on renal function in patients with coronavirus disease 2019 (COVID-19) and renal insufficiency. Methods Clinical data of renal insufficiency patients with COVID-19, who were hospitalized at Beijing Ditan Hospital, Capital Medical University from March 23, 2022 to April 30, 2023 and received Paxlovid treatment, were collected. A retrospective analysis was conducted on the incidence of Paxlovid-related acute kidney injury (AKI) and changes of blood urea, serum creatinine (Scr), blood uric acid, and estimated glomerular filtration rate (eGFR) in patients before and after Paxlovid treatment. Results A total of 386 patients were included in the analysis, including 220 males (57.0%) and 166 females (43.0%), with a median age of 79 years. COVID-19 was classified as asymptomatic in 42 patients (10.9%), mild in 175 patients (45.4%), moderate in 126 patients (32.6%), severe in 34 patients (8.8%), and critical in 9 patients (2.3%). The renal insufficiency was mild in 246 patients (63.7%), moderate in 110 patients (28.5%), and severe in 30 patients (7.8%). Among 386 patients, 16 (4.1%) developed AKI during Paxlovid treatment or within 48-hours after withdrawal, 5 (1.3%) of which were judged to be related to Paxlovid. The 5 patients aged 70 years and above, and all used nephrotoxic drugs. After Paxlovid treatment, the blood urea, Scr, blood uric acid, and eGFR in the 386 patients were all improved compared to before, and the differences were statistically significant [Scr: (133.8±9.3) μmol/L vs. (111.7±6.6) μmol/L; blood uric acid: (335.9±7.1) μmol/L vs. (291.9±5.8) μmol/L; eGFR: (63.4±1.1) ml/(min·1.73 m2) vs. (69.1±1.2) ml/(min·1.73 m2); all P<0.05]. Conclusions The overall safety of Paxlovid treatment for COVID-19 in patients with renal insufficiency is good, and it has no significant impact on the renal function in the vast majority of patients. However, for elderly people aged 70 years and above, especially for those who have combination medications of nephrotoxic drugs, the occurrence of AKI should still be vigilant.
  • Rui Min, Wang Jianjie, Ling Zhigang
    Adverse Drug Reactions Journal. 2025, 27(3): 162-168. https://doi.org/10.3760/cma.j.cn114015-20240613-00439
    Objective To understand the influencing factors for cardio-cerebrovascular complications in patients with T2DM and construct a nomogram risk prediction. Methods The study design was a prospective observational study, and the subjects were selected from hospitalized patients with T2DM admitted to Huangshan City People′s Hospital from May 2022 to April 2023. Data on patients' gender, age, body mass index, alcohol consumption, smoking status, family history of cardio-cerebrovascular diseases, insulin use, duration of diabetes, blood pressure, and routine laboratory test results were collected using the hospital electronic medical record system. At discharge, patients were assessed using the T2DM-Specific Medication Belief Scale (total score range: 10-50), Medication Literacy Assessment Scale (total score range: 0-7), and Morisky Medication Adherence Scale (total score range: 0-8). Patients were followed up by telephone for 6 months after discharge and divided into 2 groups based on the occurrence of cardio-cerebrovascular complications. Logistic regression analysis was performed using SPSS 26.0 software to identify influencing factors for cardio-cerebrovascular complications in T2DM patients. A nomogram prediction model was constructed using R 4.1.0 software, and internal validation of the model was conducted using the Bootstrap method. Results A total of 294 T2DM patients were included in the analysis. The medication belief score was (32.6±5.6) score, the medication literacy score was (4.2±0.5) score, and the medication adherence score was (6.1±0.8) score. During the 6 month follow-up, a total of 43 patients (14.6%) experienced cardio- cerebrovascular complications, including of coronary heart disease (23 cases), heart failure (12 cases), and stroke (8 cases). Compared to patients without cardio-cerebrovascular complications, patients with complications had higher body mass index, glycosylated hemoglobin A1c (HbA1c), D-dimer, and uric acid levels, as well as lower medi- cation belief scores, medication literacy scores, and medication adherence scores (all P<0.05). Binary logistic regression analysis showed that HbA1c, D-dimer, uric acid, medication belief, medication literacy, and medication adherence were influencing factors for cardio-cerebrovascular complications in T2DM patients. Accordingly, a nomogram prediction model was established. Internal validation results of the model showed that the concordance index was 0.958, the area under the receiver operating characteristic curve was 0.824, and the calibration curve was close to the ideal curve. Conclusions The current status of medication belief, medication literacy, and medication adherence in T2DM patients was not ideal. High levels of HbA1c, D-dimer, and uric acid, as well as poor medication belief, medication literacy, and medication adherence were risk factors for cardio-cerebrovascular complications in T2DM patients. The nomogram model, which integrated multiple influencing factors, had high value in predicting the risks.
  • ADE简报
    . 2000, 2(2): 132-132.
  • 不良事件
    . 2005, 7(1): 67-67.
  • 病例报告
    . 2005, 7(5): 371-372.
  • 病例报告
    . 2001, 3(1): 44-45.
  • 不良事件
    . 2006, 8(1): 62-62.
  • 病例报告
    . 2001, 3(1): 50-50.
  • WHO信息
    . 2004, 6(3): 204-204.
  • 不良事件
    . 2004, 6(5): 345-345.
  • 不良事件
    . 2002, 4(5): 344-344.
  • ADR咨询
    . 2006, 8(3): 234-234.
  • un Lirui, Zhang Hongmei, Guo Qiushi, Tian Xu, Sun Zhihui
    Adverse Drug Reactions Journal. 2019, 21(4): 290-291. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.009
    A 35-year-old male patient received an IV infusion of flurbiprofen axetil 100 mg, which was diluted in 100 ml of 0.9% sodium chloride injection, once daily for waist and abdomen persistent colic because of right ureteral calculi. The patient developed dyspnea, facial swelling, nasal obstruction, runny nose, and laryngeal edema after the first dose of flurbiprofen axetil infusion for about 20 minutes (infusion volume was about 50 ml). Flurbiprofen axetil allergy was considered. Flurbiprofen axetil was stopped immediately and anti-allergy treatments with adrenaline, dexamethasone, budesonide, and promethazine were given, accompanied with symptomatic supportive treatment with oxygen. About 30 minutes later, the patient′s dyspnea relieved and 3 hours later, the facial swelling, nasal obstruction, runny nose, and laryngeal edema disappeared. Then IV infusions of cefuroxime sodium and phloroglucinol were given and the patient′s waist and abdomen pain obviously improved 3 days later.
  • Zhao Zinan, Zhu Yuanchao, Liang Liang, Chen Di, Zhang Yatong
    Adverse Drug Reactions Journal. 2019, 21(4): 244-251. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.002
    ObjectiveTo systematically evaluate the risk of major bleeding and major adverse cardiac events(MACE) in patients with acute coronary syndrome(ACS) after combined use of novel oral anticoagulants (NOAC) and antiplatelet therapy.MethodsRandomized controlled trials (RCTs) about NOAC treatment for ACS patients with basic antiplatelet therapy in related databases (up to July 2018) were searched. The outcome indicators included major bleeding events (safety indicators) and MACE (effectiveness indicators). Quality of methodology was evaluated using bias risk assessment tool of Cochrane collaboration networks. Meta-analysis was performed using RevMan 5.3 software.ResultsA total of 6 RCTs were entered, including comparative studies of single antiplatelet therapy (SAPT) or dual antiplatelet therapy (DAPT) combined with NOAC and combined with placebo or warfarin, involving 20 070 patients. Drugs used in the trial group included apixaban, rivaroxaban, and dabigatran etexilate. The quality evaluation showed that 4 of the 6 RCTs were with low risks of bias and 2 with high risks of bias. The meta-analysis showed that the risk of clinical major bleeding events in patients in the SAPT+NOAC group was significantly higher than that in the SAPT+placebo group [3.14% (44/1 402) vs. 1.07% (19/1 770), RR=3.47, 95%CI: 2.01-5.97, P<0.001]. The incidence of clinical major bleeding events in patients in the DAPT+NOAC group was significantly higher than that in the DAPT+placebo group [5.72% (387/6 761) vs. 2.79% (251/8 984), RR=2.59, 95%CI: 1.73-3.86, P<0.001], but significantly lower than that in the DAPT+warfarin group[17.22% (422/2 450) vs. 25.68% (627/2 442), RR=0.68, 95%CI: 0.56-0.82, P<0.001]. The risk of MACE in patients in the SAPT+NOAC group was significantly lower than that in the SAPT+placebo group [8.61% (121/1 405) vs. 12.20% (217/1 779), OR=0.69, 95%CI: 0.55-0.88, P=0.003]; there were no significant differences in the risks of MACE between patients in the DAPT+NOAC group and the DAPT+placebo group or DAPT+warfarin group (P>0.05 for both).ConclusionsCombination of anticoagulants and SAPT or DAPT in ACS patients may all increase the risk of clinical major bleeding, but combination of SAPT and NOAC may reduce the risk of MACE, and should be used after weighing. For patients who must be treated with triple antithrombotic therapy, DAPT combined with NOAC can be chosen and warfarin should be avoided.
  • Liu Baogang1, Li Xiaoling1, Yan Suying1, Wang Ruili2, Zhang Bin1, Cui Xiaohui1
    Adverse Drug Reactions Journal. 2019, 21(1): 36-42. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.007
    The study on safety alerts in computerized physician order entry started from the 90s of 20 century. The forms of safety alerts comprised mainly 2 kinds, invasive and non-invasive alerts. The contents of alert mainly included drug-drug interaction(DDI), medication of patients with renal insufficiency, potential inappropriate medication of the elderly, irrational use of antibiotics, medication of pregnancy women, and drug allergy. Comparing with non-invasive alerts and non-tiered alerts respectively, the rates of prescription modification due to invasive alerts and tiered alerts increased significantly. The rate of prescription modification due to DDI alerts was significantly higher than that due to potential inappropriate medication alerts of the elderly or drug allergy alerts. Most studies have suggested that the rate of prescription errors decreased after using the electronic prescription safety alert system, and the major factor affecting the effectiveness was alert fatigue. The factors affecting the acceptance rates of alerts mainly included the alert interface setting (color, shape, and etc.), the content of the alerts, the type of drugs, being tiered or not according to the severity of alerts, specific recommendations for prescription modification being given or not, repetition rate of the alerts, and the prescribers′ professional level, and etc. The developments of safety alerts in computerized prescriber order entry system in the United States, United Kingdom, and Japan are relatively mature and their hospital popularity rates are relatively high. The research on safety alerts in computerized prescriber order entry system in China is relatively late and needs to be further strengthened.
  • ADR咨询
    . 2006, 8(3): 234-234.
  • ADR咨询
    . 2004, 6(3): 205-205.
  • ADR咨询
    . 1999, 1(2): 79-79.
  • ADR系列问答
    . 2007, 9(1): 74-74.
  • WHO信息
    . 2002, 4(3): 207-207.
  • 病例报告
    . 2000, 2(4): 262-263.
  • 不良事件
    . 2002, 4(1): 55-56.
  • WHO信息
    . 2003, 5(2): 134-135.
  • 不良事件
    . 2005, 7(6): 463-464.
  • 病例报告
    . 2006, 8(2): 136-137.
  • 不良事件
    . 2003, 5(5): 354-354.
  • 不良事件
    . 2004, 6(2): 128-128.
  • 不良事件
    . 2005, 7(4): 311-312.
  • 病例报告
    . 2002, 4(3): 194-195.
  • ADE简报
    . 2000, 2(2): 130-131.
  • 病例报告
    . 2001, 3(4): 256-257.
  • 病例报道
    . 1999, 1(1): 56-57.
  • 不良事件
    . 2005, 7(3): 229-230.
  • 不良事件
    . 2003, 5(3): 201-202.
  • 不良事件
    . 2003, 5(3): 198-198.
  • ADR监测与防治
    . 2000, 2(3): 175-176.
  • SARS防治
    . 2003, 5(3): 149-150.
  • ADE简报
    . 2001, 3(3): 202-202.
  • WHO信息
    . 2004, 6(5): 351-351.
  • WHO信息
    . 2004, 6(5): 350-350.
  • ADR系列问答
    . 2007, 9(2): 152-152.
  • ADR咨询
    . 2004, 6(1): 64-64.
  • ADR咨询
    . 2006, 8(2): 154-154.
  • ang Weibo, Tang Mengchen
    Adverse Drug Reactions Journal. 2019, 21(3): 227-228. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.014
    An 86-year-old male patient received parenteral nutrition therapy [IV infusions of alanyl glutamine injection 100 ml once daily and fat emulsion, amino acids (17) and glucose (11%) injection 1 440 ml once daily] for hypovolemic shock and malnutrition. His liver function was normal before medication. On day 23 after medication, the patient developed mild yellowish skin. Laboratory tests showed alanine aminotransferase (ALT) 342 U/L, aspartate aminotransferase (AST) 236 U/L, γ-glutamyl transpeptidase (γ-GT) 322 U/L, alkaline phosphatase (ALP) 308 U/L, and total bilirubin (TBil) 116.2 μmol/L. On day 25 after medication, the yellowish skin was aggravated. The above treatments were continued because of less food intake and hepatoprotective drugs were given at the same time. On day 32 after medication, laboratory tests showed ALT 186 U/L, AST 113 U/L, γ-GT 237 U/L, ALP 220 U/L, and TBil 139.7 μmol/L. The parenteral nutrition therapy was stopped and the liver protection therapy was continued. On day 44 after the drugs withdrawal, the patient′s jaundice disappeared, ALT 12 U/L, AST 14 U/L, γ-GT 37 U/L, ALP 72 U/L, and TBil 27 μmol/L.
  • Cai Jun, Wei Jing, Ji Liwei
    Adverse Drug Reactions Journal. 2019, 21(6): 461-462. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.018
    A 61-year-old female patient with type 2 diabetes mellitus were prescribed a subcutaneous injection of insulin glargine 12 U at bedtime by the doctor because of the poor effect of oral hypoglycemic drugs. Because she used the drug for the first time and didn′t master the skills of use, a total of 300 U of insulin glargine was mistakenly injected subcutaneously at one time. About 3 hours later, the patient developed hypoglycemia symptoms such as palpitation, profuse sweating, hunger, and etc. The finger-prick blood glucose was 3.0 mmol/L and her symptoms improved after eating. No antidiabetic drugs were used that day and normal meals were taken, including sweet food. At about 3:00 am the next day (about 25 hours after the administration of insulin glargine injection), hypoglycemia recurred, the finger-prick blood glucose was 3.3 mmol/L, and the symptoms was improved after eating. On the 4 consecutive days after then, no hypoglycemic drugs were used. From the 5th day, acarbose, metformin and insulin glargine injection were added successively. One week later, the fasting finger-prick blood glucose was 5.9-6.7 mmol/L, and the finger-prick blood glucose was 6.0-7.7 mmol/L at 2 hours after meal. Hypoglycemia did not recur.
  • Zhang Lijuan, Yan Junfeng, Chen Lu, Tu Cuiping
    ObjectiveTo establish a detection method for simultaneous determination of plasma concentrations of paraquat and diquat by high performance liquid chromatography (HPLC).MethodsAll the plasma samples were pretreated using 35% perchloric acid and microporous filtering film. The chromatographic peaks of paraquat and diquat were measured by high performance liquid chromatograph (Waters 2695). The mobile phase was acetonitrile∶  buffer (6∶  94). The buffer contained 20 mmol/L reversed-phase ion pair sodium 1-heptane sulfonate and 1.5% phosphoric acid. The buffer′s pH was adjusted to 2.0 with triethylamine. The column temperature was 40 ℃. The flow speed was 0.8 ml/min. The detection wavelengths of paraquat and diquat were 254 nm and 309 nm. The plasma concentrations of paraquat and diquat were calculated according to the chromatographic peak area of paraquat and diquat and the standard curves were run on the same day.ResultsThe paraquat and diquat chromatographic peaks detected by reversed phase ion-pair liquid chromatography showed good shape. The retention times of paraquat and diquat were 4.652 and 5.066 min, respectively. Peaks of paraquat and diquat were separated well and not disturbed by impurity peaks. Paraquat had a good linear relationship between the chromatographic peak area and the concentrations in the range of 0.097 7-50.000 0 μg/ml, the lowest detection concentration was 0.090 0 μg/ml. Diquat had a good linear relationship between the chromatographic peak area and the concentrations in the range of 0.097 7-50.000 0 μg/ml, the lowest detection concentration was 0.070 0 μg/ml. The absolute recovery and relative recovery of paraquat at high, medium and low concentrations were 98.75% to 103.86% and 102.29% to 107.26%, respectively. The absolute recoveries and relative recoveries of diquat at high, medium and low concentrations were 99.67% to 111.55% and 100.85% to 101.94%, respectively. Their relative standard deviations (RSD) were all <3%. The mean values of within-day precision in high, medium, and low concentrations of paraquat were 51.030 0, 6.429 6, and 0.767 0 μg/ml, respectively. The mean values of within-day precision in high, medium, and low concentrations of diquat were 50.178 6, 6.509 1, and 0.829 4 μg/ml, respectively. The RSD of within-day precisions of paraquat and diquat were 0.40%-3.22%. The mean values of day to day precision in high, medium, and low concentrations of paraquat were 52.707 5, 6.442 5 and 0.767 5 μg/ml, respectively. The mean values of day to day precision in high, medium, and low concentrations of diquat were 51.650 1, 6.519 2 and, 0.829 3 μg/ml, respectively. The day to day precisions (RSD) of paraquat and diquat were 0.20%-2.49%. The detection results of the standard plasma samples in high, medium and low concentrations which were repeatedly frozen and thawed (1 and 2 times) at  70 ℃, preserved at -20 ℃ at different time (3 and 7 days), lied  at room temperature at different time (8 and 24 hours), lied at 4 ℃ at different time (1 and 2 days), and the standard plasma samples which were not treated with above-mentioned measures showed that all RSDs were <10%.ConclusionsA detection method for simultaneous determination of plasma concentrations of paraquat and diquat by reversed-phase ion-pair liquid chromatography was established. The method is fast and accurate.
  • Zeng Lu, Zhou Ling
    Adverse Drug Reactions Journal. 2018, 20(6): 448-449. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.012
    A 72-year-old male patient who had undergone percutaneous coronary intervention (PCI) twice previously was admitted to the First Affiliated Hospital of Soochow University  because of relapsing coronary artery stenosis and scheduled to undergo PCI again. Previously, he was given a routine dose of dual antiplatelet therapy (clopidogrel 75 mg/d and aspirin 100 mg/d) orally after the two PCI without any obvious adverse reactions. On the day of admission, the patient received a low loading dose of clopidogrel (300 mg) and aspirin (100 mg) orally, and then developed acute visible hematuria in about 2 hours after the medication. The ultrasonography revealed blood clots in his bladder and routine urine test revealed red blood cells 58 686 per microlitre. On day 2 of admission, not aspirin but clopidogrel was discontinued. On day 5 of admission, his urine color and ultrasound imaging of the urinary system returned to normal. On day 8, his routine urine test showed normal and clopidogrel 50 mg/d was given. On day 15, the dose of clopidogrel was increased to 75 mg/d. On day 19, the patient received PCI, implanting a drug-eluting stent in the left anterior descending coronary artery, and dual antiplatelet therapy was given at routine dose after the operation. On day 3 of postoperation, the patient recovered well and was discharged from hospital. After 1 month of follow-up, hematuria did not recur.
  • Gao Feng, Bai Fang, Tao Hai
    Adverse Drug Reactions Journal. 2019, 21(6): 463-464. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.019
    A 49-year-old male patient received 2 tegafur, gimeracil and oteracil potassium capsules (each capsule containing tegafur 25 mg, gimeracil 7.25 mg, and oteracil potassium 24.5 mg) orally twice daily for 2 weeks continuously following 1 week of withdrawal (every 3 weeks was a cycle) for colon cancer. After 2 cycles of treatment, the patient developed epiphora in both eyes. He continued to take the medicine and his epiphora aggravated. After 3 cycles of treatment, the drug was discontinued but his epiphora did not improve. Lacrimal duct obstruction in both eyes was diagnosed, which did not improve after the lacrimal passage irrigation treatment for 22 months. Then the patient underwent consecutive surgical treatments on his left and right eyes, including dacryocystectomy (with tiny incision for exploration), retrograde drainage of lacrimal canaliculi, punctoplasty, modified dacryocystorhinostomy, and artificial lacrimal canaliculus implantation. After the above operations, his epiphora disappeared. Based on the previous literature, the lacrimal duct obstruction in both eyes induced by tegafur, gimeracil and oteracil potassium capsules was considered.
  • Wang Xinlu, Li Yueyang, Yan Huiyu, Wang Xiangfeng
    Adverse Drug Reactions Journal. 2019, 21(4): 297-298. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.013
    A 43-year-old female patient was given IV infusions of reduced glutathione for injection (1.2 g,  added in 100 ml of 5% glucose injection), polyenephosphatidylcholine (697.5 mg, added in 250 ml of 5%  glucose injection), and compound glycyrrhizin for injection (120 mg, added in 250 ml of 5% glucose injection) once daily for liver injury. After 20 minutes of the first infusion of compound glycyrrhizin for injection (the injection volume was about 50 ml), the patient developed skin rash, palpitations, dyspnea, drenching sweats, abdominal pain, and dysphoria. Meanwhile her heart rate was 126 beats/min and blood pressure was 85/45 mmHg. In consideration of anaphylactic shock caused by compound glycyrrhizin, the drug was immediately stopped and IV injections of dexamethasone, promethazine hydrochloride, and calcium gluconate were given. Then the patient′s symptoms relieved. Except for polyenephosphatidylcholine, the compound glycyrrhizin for injection and reduced glutathione for injection were discontinued the next day and IV infusion of acetylcysteine (8 g, added in 250 ml of 10% glucose injection) once daily and oral bicyclol tablets 50 mg thrice daily were given. The patient did not developed anaphylaxis again. Seven days later, the patient′s fatigue induced by liver injury obviously improved.
  • Xie Jike, Hu Yongfang, Yan Xuelian
    Adverse Drug Reactions Journal. 2019, 21(2): 150-151. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.018
    A 30-year-old male patient received IV infusions of lysine acetylsalicylate 0.9 g dissolved in 0.9% sodium chloride injection 100 ml, ceftriaxone 4.0 g and dexamethasone 5 mg together dissolved in 0.9% sodium chloride injection 250 ml, and Qingkailing injection 30 ml dissolved in 5% glucose injection 250 ml once daily for 2 days in a local clinic for common cold. On day 3 of the drugs withdrawal, the patient developed rash on multiple parts of both hands, accompanied by pruritus. The next day, he developed fever and his body temperature rose to 40 ℃. Over the next few days, the rash gradually spread to his whole body and herpes appeared. Laboratory tests showed that alanine aminotransferase 1 012 U/L,aspartate aminotransferase 413 U/L, total bilirubin 92.5 μmol/L, and direct bilirubin 72.1 μmol/L. Seven days after the onset of rash, the area of skin lesions, blisters, and exfoliation respectively reached 60%-70%, 20%-30%, and >30% of his body surface area. The patient was diagnosed with toxic epidermal necrolysis complicated with liver injury. The IV infusions of methylprednisolone and immunoglobulin and symptomatic support treatments including timely skin care, hepatoprotective drugs, and anti-infection drugs were given, and his skin lesions gradually improved. After 7 days of treatments, methylprednisolone was changed to be taken orally and gradually reduced to discontinuation. Symptomatic treatments such as hepatoprotective therapy lasted for more than 3 weeks. After 40 days, his skin lesions healed.
  • ADR咨询
    . 2004, 6(2): 139-139.
  • ADR咨询
    . 2001, 3(2): 140-140.
  • ADR咨询
    . 2002, 4(1): 63-63.
  • ADE简报
    . 2000, 2(1): 61-61.
  • 不良事件
    . 2002, 4(5): 346-347.
  • ADE简报
    . 2001, 3(3): 203-203.
  • 不良事件
    . 2003, 5(2): 121-121.
  • ADE简报
    . 2001, 3(1): 54-54.
  • ADE简报
    . 2000, 2(3): 200-200.
  • 药物安全动态
    . 2006, 8(2): 153-153.
  • 不良事件
    . 2005, 7(4): 310-310.
  • 不良事件
    . 2004, 6(2): 132-132.
  • WHO信息
    . 2001, 3(2): 129-129.
  • 病例报道
    . 1999, 1(2): 114-115.
  • 不良事件
    . 2005, 7(5): 386-387.
  • 不良事件
    . 2003, 5(5): 348-349.
  • 不良事件
    . 2003, 5(5): 346-347.
  • 不良事件
    . 2004, 6(3): 195-196.
  • WHO信息
    . 2004, 6(6): 423-423.
  • WHO信息
    . 2003, 5(4): 277-277.
  • 不良事件
    . 2003, 5(2): 125-125.
  • 不良事件
    . 2002, 4(3): 201-201.
  • 病例报告
    . 2000, 2(1): 54-55.
  • ADE简报
    . 1999, 1(3): 191-192.
  • 病例报告
    . 1999, 1(3): 181-182.
  • ADR咨询
    . 2001, 3(2): 140-140.
  • ADR咨询
    . 2003, 5(2): 136-136.
  • Wang Chunhui, Wang Weiguang, Li Xiaoyu, Lyu Qianzhou, Liu Peng
    Adverse Drug Reactions Journal. 2019, 21(4): 315-317. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.022
    A 53-year-old male patient with follicular lymphoma received R-GDP chemotherapy regimen (rituximab+gemcitabine+dexamethasone; the treatment course was 21 days), which was terminated for drug-induced renal injury occurring on day 5 of the treatment.  The patient developed scrotal edema 14 days after the initial treatment and lenalidomide 10 mg was given orally once daily 16 days after the initial treatment. On day 5 of lenalidomide administration, the patient was treated with R-FC chemotherapy regimen (rituximab+fludarabine+cyclophosphamide; the treatment course was 28 days). On day 17, the scrotal edema relieved, but agranulocytosis[white blood count (WBC) 1.8×109/L, neutrophil ratio 0.06] occurred. Lenalidomide was considered to be the cause and was discontinued. On day 9 after lenalidomide withdrawal, the patient′s WBC was 6.8 ×109/L and neutrophil ratio was 0.48. Lenalidomide was re-given orally in consideration of the need for cancer treatment. On day 4 of lenalidomide re-administration, the patient developed low fever, left lower extremity pain, and increased bilateral inguinal lymph node mass. On day 7 to day 9, the pain and muscle tone of his left lower extremity increased and, in consideration of the tumor flare reaction caused by lenalidomide, morphine and dexamethasone were given, after which the pain decreased and the body temperature returned to normal. On day 15, his left lower extremity pain increased again and then improved after fentanyl and methylprednisolone treatment. On day 18, the patient re-examination showed WBC 0.5×107/L and neutrophil ratio 0.24. Lenalidomide therapy was terminated. On day 26, the patient′s WBC was 4.2×109/L, neutrophil ratio was 0.85, and he was transferred to other hospitals.
  • Chen Wen, Wang Lixia, Mu Jizheng, Liu Shuo
    Adverse Drug Reactions Journal. 2019, 21(6): 455-456. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.015
    A 55-year-old male patient with small-cell lung cancer received single agent chemotherapy with an IV infusion of paclitaxel injection 300 mg after surgery, which was given once only on the first day and 21 days was a treatment cycle. On day 6 after the first dose, he developed cough with white phlegm. On day 7 after the first dose, he developed fever. Piperacillin sodium and sulbactam sodium was empirically given but his symptoms were not relieved. On day 9 after the first dose, the patient developed obvious asthmatic symptoms. The chest CT result showed multiple patchy and ground glass shadows in bilateral lungs. Interstitial pneumonia caused by paclitaxel was considered. After 5 days of treatments with antibiotics and glucocorticoids, his body temperature returned to normal and asthmatic symptoms were relieved. The patient was transferred to the local hospital and his condition improved after further treatments.
  • 安全信息
    . 2011, 13(4): 267-1.
  • 不良事件
    . 2004, 6(5): 344-344.
  • 不良事件
    . 2003, 5(4): 271-271.
  • 不良事件
    . 2002, 4(1): 55-55.
  • WHO信息
    . 2002, 4(4): 275-275.
  • 不良事件
    . 2002, 4(6): 412-412.
  • ADE简报
    . 2000, 2(2): 131-132.
  • ADE简报
    . 2000, 2(3): 198-199.
  • 不良事件
    . 2005, 7(6): 463-463.
  • 不良事件
    . 2005, 7(5): 390-391.
  • 不良事件
    . 2004, 6(2): 133-133.
  • 药物安全动态
    . 2006, 8(2): 152-152.
  • 不良事件
    . 2004, 6(3): 197-198.
  • WHO信息
    . 2002, 4(6): 418-418.
  • 不良事件
    . 2002, 4(1): 56-56.
  • 不良事件
    . 2002, 4(3): 201-202.
  • 不良事件
    . 2002, 4(5): 347-347.
  • ADR咨询
    . 2002, 4(5): 353-353.
  • ADR咨询
    . 2003, 5(3): 209-209.
  • ADE简报
    . 1999, 1(3): 191-191.
  • Zhang Xin, Fang Shengbo, Zhou Na
    Adverse Drug Reactions Journal. 2019, 21(4): 295-296. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.012
    A 27-year-old male patient underwent left maxillary masses excision for periapical cysts in the left maxillary under general anesthesia. During the surgery, a venous access was established from the peripheral vein of the patient′s left lower extremity, and anesthetic drugs (propofol injection, succinylcholine chloride injection, remifentanil hydrochloride for injection, dexmedetomidine hydrochloride injection) were given. On day 2 after surgery, the patient developed topical redness and swelling along the blood vessel on his left lower extremity, which gradually developed into a cord-like redness and swelling, with increased blood vessel stiffness. He was diagnosed with thrombophlebitis of the left great saphenous vein after a ultrasound examination of the blood vessel. Treatments such as subcutaneous injection of enoxaparin sodium, oral administration of extract of horse chestnut seeds, topical mucopolysaccharide polysulfate cream, physiotherapy, and etc. were given. On day 10 after surgery, the redness and swelling on the patient′s left lower extremity disappeared, and the blood vessel was softened. At 2 months of follow-up, ultrasound examination revealed partial recanalization of the left venous trunk (the calf part) of saphenous vein. According to the drug labels and literature reports, it was considered that the patient′s thrombophlebitis might be associated with propofol injection.
  • Adverse Drug Reactions Journal. 2019, 21(1): 76-76. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.021
  • Ke Wei, Liu Min, Li Yueyang, Wang Xiangfeng
    Adverse Drug Reactions Journal. 2018, 20(6): 474-475. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.025
    An 82-year-old female patient received oral isosorbide mononitrate sustaind-release capsules 50 mg once daily, an IV infusion of Danshen Duofensuan Yan (丹参多酚酸盐) 200 mg dissolved in 5% glucose injection 250 ml once daily, oral itopride 50 mg thrice daily, and oral compound digestive enzyme capsules (Ⅱ) 1 pill thrice daily for unstable angina, coronary atherosclerotic heart disease, and gastroesophageal reflux (GER). On day 3 of treatments, the patient suddenly presented with sweating, fever (39 ℃), accompanied by coarse tremor in limbs and intention tremor in both upper limbs. Blood routine test showed no obvious abnormality. It was considered that itopride induced the extrapyramidal symptoms. Itopril was withdrawn and an IV injection of diazepam 10 mg, physical cooling, and mental comfort were given. About 2 hours later, the patient′s temperature returned to normal and about 8 hours later, the tremor disappeared. Other drugs were continued to use and no similar symptoms recurred.
  • Dong Siyao, Chen Shuxuan, Wang Yan'gai, Chen Bing, Bai Xiangrong
    Adverse Drug Reactions Journal. 2024, 26(5): 307-311. https://doi.org/10.3760/cma.j.cn114015-20231211-00883
    Polymyxin B is a cyclopeptide antibiotic drug with a narrow therapeutic window and critical nephrotoxicity. However, with the emergence of carbapenem-resistant organisms and the increase of multidrug resistant and polydrug resistant, the clinical value of polymyxin B was emphasized. It has become the last defense against polydrug resistant Gram-negative bacterial infections. The pharmacokinetic process of polymyxin B is affected by physiological and pathological changes in critically ill patients. At present, guidelines and consensus do not recommend dose adjustment based on the severity of renal injury, there is a lack of basis for dosage selection in patients receiving continuous renal replacement therapy, and different views exist in some pharmacokinetic studies and clinical studies. However, it is helpful to improve disease prognosis and reduce the risk of nephrotoxicity to carry out therapeutic drug monitoring of polymyxin B in patients with renal insufficiency, to adjust the dose according to the monitoring results, and to realize precision medication.
  • Zhang Hong, Chen Lei, Wang Qi, Wang Xiaojuan
    Adverse Drug Reactions Journal. 2024, 26(4): 211-216. https://doi.org/10.3760/cma.j.cn114015-20231108-00785
    Objective To explore the occurrence, clinical characteristics and influencing factors of hypoglycemia induced by somatostatin in patients with acute pancreatitis (AP). Methods The electronic medical records of AP patients treated with somatostatin in Fuyang people′s Hospital from May 1, 2019 to September 10, 2023 were collected. Patients with hypoglycemia caused by somatostatin were screened out, and the clinical characteristics of these patients were retrospectively analyzed. Patients were divided into hypoglycemia group and non-hypoglycemia group according to whether somatostatin-related hypoglycemia occurred. The clinical characteristics in patients of the 2 groups were compared and the influencing factors of somatostatin related hypoglycemia were analyzed using multivariate logistic regression method. The effect sizes were the odds ratio (OR) and its 95% confidence interval (CI). Results A total of 353 patients were included in the analysis and 33 patients were diagnosed with somatostatin-related hypoglycemia, with an incidence of 9.3%. Of the 33 patients, 22 (66.7%) were male and 11 (33.3%) were female, aged (52±20) years. Thirty-three patients experienced a total of 66-hypoglycemic events, of which 17 (51.5%) had multiple episodes (≥2). The median blood glucose of 66-hypoglycemic events was 2.7-mmol/L, ranging from 1.8 to 3.8-mmol/L. Fifty-six times of hypoglycemia occurred during somatostatin treatment in 30 patients (90.9%), with a median time of 3 (2, 4) days for the first occurrence of somatostatin, and 39.3% (22/56) and 21.4% (12/56) of hypoglycemia episodes occurred in the first half of the night (18:00 to 23:59) and the second half of the night (0:00 to 5:59), respectively. Ten times of hypoglycemia occurred 4-7 days after somatostatin withdrawal in 3 patients (9.1%). Multivariate logistic regression analysis showed that diabetes mellitus was an independent risk factor for the occurrence of somatostatin related hypoglycemia in patients with AP (OR=6.574, 95%CI: 1.911-22.430, P=0.003), while high serum total protein and parenteral nutrition support were protective factors (OR=0.940, 95%CI: 0.885-0.998,P=0.043; OR=0.405, 95%CI: 0.166-0.990, P=0.047). Conclusions Patients with AP should be alert to the occurrence of hypoglycemia during somatostatin treatment and within 1 week after drug withdrawal, especially at night. Diabetes mellitus and low serum total protein were independent risk factors for the occurrence of somatostatin-related hypoglycemia in patients with AP, while parenteral nutrition support was a protective factor.
  • Jiang Weihao, Bian Yuan, Long Enwu
    Adverse Drug Reactions Journal. 2024, 26(12): 749-755. https://doi.org/10.3760/cma.j.cn114015-20240617-00452
    Glucagon-like peptide-1 receptor agonists (GLP-1RA) are used to treat type 2 diabetes mellitus (T2DM) by enhancing insulin secretion and inhibiting glucagon secretion. GLP-1RA has good efficacy and safety, but it may have the risk of pancreatic injury. Its incidence is low, but it is more harmful. At present, the research conclusions of GLP-1RA-related pancreatic injury are not consistent. This article reviews the research progress of GLP-1RA-related pancreatic injury from the aspects of occurrence, possible mechanism, related clinical research, clinical manifestations, and management measures. The possible mecha- nisms include activation of stellate cells, induction of proliferation and metaplasia of pancreatic ductal epithelial cells, presence of immune rejection, and influence on the expression of pancreatic injury related genes. Pancreatitis is more common in GLP-1RA-related pancreatic injury, and its clinical manifestations are abdominal pain, nausea, vomiting, and the elevation of lipase and amylase. It is suggested that patients should be given necessary medication education before medication. Once relevant symptoms occur, acute pancreatitis should be considered and the medication should be stopped immediately. If pancreatitis is confirmed, GLP‐1RA treatment is not recommended.
  • Adverse Drug Reactions Journal. 2024, 26(9): 568-570. https://doi.org/10.3760/cma.j.cn114015⁃20230923⁃00707
    A 36-year-old healthy male served as an allogeneic hematopoietic stem cell donor was given recombinant human granulocyte colony-stimulating factor injection (rhG-CSF) 300 μg by subcutaneous injection once daily for 5 consecutive days. On day 4 of stem cell mobilization, peripheral stem cell collection was performed and rhG-CSF 250 μg was given in addition. The donor experienced dry cough, dyspnea, and difficulty breathing on the next day. Chest CT scan showed diffuse patchy and nodular shadows in both lungs, and relevant tests excluded bacterial/viral infection of the lungs and heart failure. It was considered to be acute lung injury caused by rhG-CSF. After giving glucocorticoids and symptomatic treatments, the symptoms gradually subsided, and the peripheral blood stem cell collection was successful. In the continuing treatment of glucocorticoids, the symptoms of the donor were further improved, and chest CT scan showed marked improvement. At a 3 years of follow-up, the donor‘work and life were normal, and no lung discomfort symptoms recurred.
  • ADE简报
    . 1999, 1(3): 190-190.
  • ADE简报
    . 2000, 2(1): 61-61.
  • ADR咨询
    . 2000, 2(2): 83-83.
  • 安全信息
    . 2010, 12(1): 71-2.
  • ADE简报
    . 2000, 2(4): 265-265.
  • 病例报告
    . 2003, 5(4): 261-262.
  • WHO信息
    . 2004, 6(6): 423-423.
  • 不良事件
    . 2006, 8(2): 143-144.
  • ADE简报
    . 2001, 3(2): 124-124.
  • WHO信息
    . 2001, 3(4): 264-265.
  • 病例报道
    . 1999, 1(2): 124-124.
  • WHO信息
    . 2004, 6(6): 422-422.
  • WHO信息
    . 2004, 6(6): 422-422.
  • 不良事件
    . 2003, 5(4): 270-270.
  • 不良事件
    . 2006, 8(3): 221-222.
  • ADE简报
    . 2001, 3(1): 53-53.
  • WHO信息
    . 2003, 5(4): 276-276.
  • 不良事件
    . 2002, 4(3): 202-202.
  • ADR咨询
    . 2001, 3(3): 211-211.
  • ADR咨询
    . 2004, 6(3): 205-205.
  • Liu Yang, Chen Jing, Chen Shicai
    Adverse Drug Reactions Journal. 2018, 20(6): 476-477. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.026
    A 64-year-old female patient was suspected of psoriasis due to generalized rash and received oral Xiaoyin granules (3.5 g, thrice daily) and compound amino-polypeptide tablets (5 tablets, thrice daily) following the doctor′s advice of other hospital. After 15 days of medication, the patient developed symptoms such as fatigue, nausea, and anorexia. After 17 days, dark brown urine appeared. After 24 days, the laboratory tests showed ALT 1 500 U/L and TBil 98.5 μmol/L. The Xiaoyin granules and compound amino-polypeptide tablets were immediately discontinued following the doctor′s advice, and 1 day later, the patient was admitted to our hospital. The laboratory tests showed the following results: ALT 1 156 U/L, AST 410 U/L, ALP 259 U/L, γ-GT 198 U/L, TBil 112.8 μmol/L, and DBil 92.5 μmol/L. Ruling out the liver injury caused by viral hepatitis and other factors, drug-induced liver injury was considered. Drugs such as compound glycyrrhizin injection, the reduced glutathione for injection, the methionine vitamin B1 for injection, Chidan Tuihuang granules (赤丹退黄颗粒), ursodeoxycholic acid capsules, and potassium aspartate and magnesium aspartate tablets were given. The rash disappeared and jaundice subsided respectively after 12 and 31 days of the above treatments. Liver function tests after 34 days of the medication showed ALT 19 U/L, AST 17 U/L, TBil 32.9 μmol/L, and DBil 26.0 μmol/L. Through searching the relevant literature reported before, Xiaoyin Granules was very likely related to the liver injury. Cortex Dictamni  contained in the drug is toxic to liver.
  • Huang Wei, Long Peipei
    Adverse Drug Reactions Journal. 2018, 20(6): 470-472. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.023
    A 62-year-old female patient received hemocoagulase for injection 1 KU, added into 10 ml of 0.9% sodium chloride injection in advance, by intravenous injection thrice daily after cholecystectomy. No abnormalities of preoperative blood coagulation test were found. On day 3 after the medication, the patient had extensive capillary hemorrhage from her surgical incision. The blood coagulation test showed prothrombin time (PT) 18 s, international normalized ratio (INR) 1.5, activated partial thromboplastin time (APTT) 36 s, thrombin time (TT) 88 s, fibrinogen (FIB) 0.09 g/L, and D-dimer 3.6 mg/L. Considering that the blood coagulation disorders might be caused by hemocoagulase, it was stopped and aminomethylbenzoic acid injection 0.3 g, added into 100 ml of 0.9% sodium chloride injection in advance, was given by intravenous infusion once daily. In the meantime, vitamin K1 10 mg it was given by intramuscular injection twice daily. The next day, no significant capillary hemorrhage was found in the surgical incision. Five days later, the blood coagulation test showed PT 14 s, INR 1.0, APTT 29 s, TT 20 s, FIB 2.25 g/L, and D-dimer 0.5 mg/L.
  • Wang Chunhui, Li Jing, Wu Wei, Li Wensi, Li Xiaoyu, Lyu Qianzhou
    Adverse Drug Reactions Journal. 2019, 21(4): 265-272. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.005
    ObjectiveTo evaluate the cardiac safety of trastuzumab-containing regimens in patients with HER2-positive tumors.MethodsThe clinical data of adult patients with HER2-positive breast cancer, gastric cancer or gastroesophageal junction adenocarcinoma, with normal electrocardiogram and echocardiography before treatments, and treated with trastuzumab-containing regimens in Zhongshan Hospital Affiliated to Fudan University from January 2016 to February 2018 were collected through the hospital information system and cardiac adverse events after trastuzumab-containing regimens were retrospectively analyzed., The patients were divided into 4 groups according to the application history of antineoplastic drugs: group A (neither anthracyclines nor fluoropyrimidines application history), group B (only anthracyclines application history), group C (only fluoropyrimidines application history), and group D (both anthracyclines and fluoropyrimidines application history). The occurrences of cardiac adverse events in the 4 groups were compared.ResultsA total of 90 patients were enrolled, including 34 males and 56 females, aged (60±12) years. Of them, 43 patients (47.8%) were with breast cancer, 46 (51.1%) were with gastric cancer, and 1 (1.1%) was with gastroesophageal junction adenocarcinoma. Group A, B, C, and D comprised 11, 20, 52, and 7 patients, respectively. Of the 90 patients, 65 patients developed 96 cases of adverse cardiac events. The incidence of adverse cardiac events was 72.2%. The severity of cardiac adverse events was grade 1 in 91 cases and grade 2 in 5 cases. The adverse events with higher incidence were arrhythmia (36.7%, 33/90), abnormal cardiac structure (22.2%, 20/90), valvular reflux (22.2%, 20/90), and increased pulmonary arterial systolic pressure (10.0%, 9/90). There was no significant difference in the incidence of cardiac adverse events after trastuzumab treatment in patients with different antineoplastic drug application history among the 4 groups (all P>0.05). Except for 2 patients with grade 2 sinus tachycardia whose heart rate returned to normal after treatment with beta-blocker, the other 63 patients did not need medical intervention.ConclusionThe incidence of cardiac adverse events of trastuzumab treatment in patients with HER2-positive tumors was higher, but the severity of most of them were grade 1, which rarely cause serious cardiac functional or structural damage.
  • Liu Ying, Zhao Rongsheng
    Adverse Drug Reactions Journal. 2019, 21(6): 478-480. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.027
    A 71-year-old male patient received montelukast sodium tablets 10 mg every night because of bronchiectasis with asthma. On day 4 of the medication, he developed itchy skin. On day 5, he developed blisters on his neck and wrist skin. On day 11, he developed scattered blisters filled with clear fluid on his limbs and trunk skin and part of them fused into lamella. Epidermolysis bollosa and the relationship to montelukast sodium were considered. Montelukast sodium tablets were stopped and antianaphylactic treatments including external triamcinolone acetonide and econazole nitrate cream and ethacriding lactate acid solution and oral cetirizine hydrochloride dispersible tablets were given. On day 3 of montelukast withdrawal, the blisters subsided and shriveled on his neck skin and on his limbs and trunk skin, respectively. Ulceration appeared on the skin of those subsided or shriveled blisters but no exudate. No new blisters were found. A week later, the blisters subsided basically and desquamation occurred in the skin where some blisters subsided.
  • Wang Lu, Li Weijie, Zeng Lu, Wei Anhua, Gui Ling, Zhang Wenting, Gong Xuepeng
    Adverse Drug Reactions Journal. 2024, 26(2): 126-128. https://doi.org/10.3760/cma.j.cn114015-20230130-00040
    A 55-year-old male patient was treated with tacrolimus (2.5-mg in the morning and 2-mg at night) for 6 months after lung transplantation to prevent rejection. The blood trough concentration of tacrolimus was stable at 8.0-10.0-μg/L. The patient received antiviral treatment due to corona virus disease 2019 (nirmatrelvir/ritonavir 300 mg/100 mg twice daily orally for a total of 5 days). During the antiviral treatment, the patient continued the anti-rejection treatment. On the second day of antiviral treatment, the patient′s blood trough concentration of tacrolimus increased to >40.0-μg/L, which was considered to be caused by the interaction between nirmatrelvir/ritonavir and tacrolimus. Tacrolimus was withdrawn and antiviral therapy was continued. After discontinuation of tacrolimus for 8 days and nirmatrelvir/ritonavir for 3 days, the blood trough concentration of tacrolimus decreased to 25.7-μg/L. After re-giving tacrolimus at reducing dosage for 3 days, the blood trough concentration of tacrolimus was 8.3-μg/L. After 13 days of resuming administration of tacrolimus at the original dose and frequency, the patient′s blood trough concentration of tacrolimus was 9.2-μg/L. Since then, the blood trough concentration of tacrolimus in the patient was not abnormal again.
  • Adverse Drug Reactions Journal. 2024, 26(7): 444-445. https://doi.org/10.3760/cma.j.cn114015‑20230505‑00334
  • Tang Wenjun, Yan Qixing
    Adverse Drug Reactions Journal. 2025, 27(1): 59-61. https://doi.org/10.3760/cma.j.cn114015-20240402-00220
    A 66-year-old male patient with esophageal cancer progressed after concurrent radio- therapy and chemoradiotherapy, and received immunotherapy combined with chemotherapy (intravenous infusion of sintilimab 200 mg on day 1, tegafur gimeracil oteracil potassium 50 mg orally twice daily from day 1 to 14), with 21 days as a cycle. After 13 days of treatments, diarrhea appeared, and gradually worsened with abdominal pain and a small amount of mucous bloody stools. Colonoscopy showed diffuse swelling and punctiform hemorrhagic erosion of the mucosa of the colon and rectum. Histopathological exami- nation of the ascending colon and sigmoid colon showed regular arrangement of glands, infiltration of lymphocytes, neutrophils and eosinophils in the interstitium, and formation of crypt abscesses, which were considered to be immuneassociated colitis caused by sintilimab. After discontinuing the use of sintilimab and administering lowdose methylprednisolone (24 mg orally twice daily) for 3 days, the patient′s symptoms were completely relieved. The dose of methylprednisolone was reduced gradually and discontinued within 4 weeks. The patient did not rechallenge immune checkpoint inhibitors and continued maintenance therapy with tegafur gimeracil oteracil potassium, and no diarrhea recurred
  • Adverse Drug Reactions Journal. 2024, 26(6): 362-362. https://doi.org/10.1007/s40264-023-01387-0
      根据世界卫生组织(WHO)死亡率数据库的数据和与药物不良事件(ADE)相关的国际疾病分类第10版(ICD-10)代码,作者分析了5个区域(北美洲、拉丁美洲和加勒比地区、西欧、东欧和西太平洋地区)54个国家和地区2001年至2019年ADE相关死亡率的趋势。结果显示,ADE相关死亡率从2001年的每10万人2.05(95%置信区间:0.92~3.18)上升至2019年的6.86(95%置信区间:5.76~7.95),上升了约3.3倍;男性高于女性;≥75岁人群高于年轻人群;北美洲在5个区域中最高。研究期间所有区域ADE相关死亡率都在上升,北美洲上升了约4倍,显著高于其他区域的增幅。
      作者认为这种上升趋势与全球大量新药的问世,药品使用增加,不良反应数量增加有关系。北美洲的上升趋势可能与药物过量使用,尤其是阿片类药物的过量使用相关。在英国、瑞典和澳大利亚,也观察到与药物过量相关的死亡人数增加。作者发现麻醉品中毒的占比很高,每个地区阿片类药物相关ADE死亡率都在增加。
      作者认为ADE相关死亡率地区差异大的另一个原因与许多发达国家在过去几十年中强化了药物警戒系统,能够更准确地反映药物安全情况有关。
      作者讨论了研究的局限性。(1)仅使用WHO死亡率数据库中与ICD-10代码相关的数据,而所使用的ICD-10代码不能完全对应ADE的问题,有可能导致总体的死亡率被低估;(2)样本数据仅来自WHO四分之一的会员国,且主要是发达国家,不足以代表全球的趋势;(3)WHO死亡率数据库并未包括死亡病例的背景信息,研究也无法从ICD-10代码判断药物的使用背景,不能判断死亡是否属于非法使用所导致;(4)54个国家和地区对ADE的定义不统一,作者采用的是较宽泛的定义。而根据ADE的定义,药物与不良事件并不一定是因果关系。作者认为应该开展药物警戒的国际合作,统一包括ADE在内的药物安全相关的术语。
  • Pei Keling, Wu Yuqian, Zhou Li, Lu Shushu, Zhang Tao
    Adverse Drug Reactions Journal. 2024, 26(6): 379-381. https://doi.org/10.3760/cma.j.cn114015-20230714-00525
    A 65-year-old female patient with paranoid schizophrenia switched to amisulpride due to poor treatment efficacy with risperidone, and gradually increased the dosage (0.1 g twice daily for 3 days, 0.2 g, twice daily for 2 days, and finally 0.4 g in the morning and 0.2 g in the evening). After 4 days of medication, electrocardiogram showed sinus bradycardia, with heart rate 49 beats/min and QT interval 492-ms; after 7 days of medication, dynamic electrocardiogram showed heart rate 25 beats/min (average heart rate 42 beats/min) and sinus arrest (207 R-R intervals greater than 2.0-s, with a maximum of 2.47-s). Sinus arrest in the patient mostly occurred at night. Amisulpride was reduced to 0.2 g once daily orally, and ECG monitoring was given. The next day, echocardiography showed left ventricular dyskinesia, mild mitral regurgitation, and abnormal left ventricular filling. It was considered that sinus arrest may be related to amisulpride. The drug was discontinued immediately, the dose of olanzapine increased from 5 mg/d to 10 mg/d, and other treatments remain unchanged. On the day after discontinuation of amisulpride, the number of sinus arrest in electrocardiogram monitoring significantly decreased compared to before. Three days after discontinuation, no sinus arrest was found on the dynamic electrocardiogram; 26 days later, the ECG showed sinus rhythm, with a heart rate of 60 beats/min.
  • Chen Yong, Cai Kangjun, Li Jinjian, Xu Mengdan
    Adverse Drug Reactions Journal. 2024, 26(6): 355-362. https://doi.org/10.3760/cma.j.cn114015-20231018-00741
    Objective To establish an active monitoring model for adverse reactions/events of sodium-glucose cotransporter 2 inhibitor (SGLT2i) for application and promotion in medical institutions. Methods The subjects were type 2 diabetes patients who were discharged from the First Affiliated Hospital of Guangdong Pharmaceutical University (our hospital) from March 1, 2021 to October 1, 2022 and treated with SGLT2i. The patients were divided into 2 parts and assigned to the pre-trial phase and clinical application validation phase, respectively. SGLT2i-related adverse reactions/events from domestic and foreign databases and drug labels were retrieved, and triggering items were developed preliminarily. After soliciting opinions from experts in our hospital, referring to relevant medical orders, disease course records, and laboratory indicator reference values, the triggering items were modified, and a questionnaire survey was conducted using the Delphi method. According to expert opinions, the items were sorted, analyzed, discussed, and modified to form preliminary triggering items. A monitoring model was established based on the Chinese hospital drug surveillance system, the triggering items were improved during the pre-trial phase, and validated during the clinical application phase. Results A total of 218 and 858 patients were obtained in the pre-trial phase and clinical application validation phase, respectively. Based on literature and drug labels, 44 triggering items were preliminarily formed. A total of 16-survey questionnaires from experts were collected. After being modified based on expert opinions, and further improved during the pre-trial phase, 24 triggering items were determined finally, including 8 laboratory indicators (A), 4 rescue agents (B), 11 clinical symptoms (C), and 1 intervention measure (D). The number of positive cases monitored by the model during the pre-trial phase and clinical application validation phase was 56 and 189, respectively. The actual number of positive cases under manual review was 12 and 57, respectively. The positive predictive value (PPV) of the triggering items in the pre-trial phase and clinical application phase were 25.0% (18/72) and 30.9% (77/249), respectively, with adverse reaction/event detection rates of 5.5% (12/218) and 6.6% (57/858), sensitivity of 92.3% (12/13) and 100% (57/57), and specificity of 78.5% (161/205) and 83.5% (669/801). Among the 12 positive cases in the pre-trial phase and 57 positive cases in the clinical application validation phase, the association evaluation was probable and possible (4, 8 cases and 16, 41 cases, respectively). The severity of adverse reactions/events was mainly grade 2 (11 cases and 55 cases, respectively). The main adverse reactions/events of SGLT2i were hypoglycemia, urinary tract infections, rashes, etc. Pancreatitis, weight loss, etc., which were not stated in the drug labels, were evaluated as probable. Conclusion Through pre-trial and internal clinical validation phase, the adverse reaction/event active monitoring model established for SGLT2i in this study has high sensitivity and specificity, and can be applied practically in medical institutions.
  • Yu Minji, Tao Lili
    Adverse Drug Reactions Journal. 2019, 21(3): 223-224. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.012
    A 22-year-old woman was given mifepristone tablets (150 mg, once daily) orally for 4 days and intramuscular injection of methotrexate (MTX) 75 mg once on day 4 for ectopic pregnancy. About 5 hours after injection, the patient developed nausea and vomiting. The next day, the rash appeared and scattered on the head and face with pain and itching. Loratadine tablets 10 mg once daily were given orally, but the rash gradually aggravated. On  day 5 after MTX treatment, pustules appeared on the back and chest, and oral mucosal ulceration occurred. On day 6, the patient developed persistent high fever, with white blood cell count 0.28×109/L, neutrophil count 0.07×109/L, platelet count 16×109/L, and hemoglobin 36 g/L. On day 8, the patient developed skin and mucosa swelling, accompanied by ulcer, epistaxis and superficial lymph node tumefaction. The patient was diagnosed with severe myelosuppression and sepsis, which was caused by methotrexate. Symptomatic and supportive treatments such as anti-allergy, anti-infection, leukocyte proliferation, antipyretic, and intravenous gamma globulin were given. Due to the limited hospital condition, without salvage therapy with calcium folinate was given. The patient′s condition became worse and she eventually died of multiple organ failure on day 17 after MTX treatment.
  • ADR咨询
    . 2006, 8(2): 154-154.
  • ADR咨询
    . 2003, 5(3): 209-209.
  • 安全信息
    . 2011, 13(5): 336-2.
  • 病例报告
    . 2006, 8(4): 299-300.
  • 病例报告
    . 2006, 8(4): 305-305.
  • 不良事件
    . 2002, 4(5): 348-348.
  • WHO信息
    . 2001, 3(1): 57-57.
  • 病例报告
    . 2001, 3(1): 48-49.
  • 病例报告
    . 2005, 7(4): 294-295.
  • WHO信息
    . 2003, 5(2): 133-133.
  • WHO信息
    . 2002, 4(4): 277-277.
  • WHO信息
    . 2003, 5(3): 208-208.
  • 病例报告
    . 2002, 4(6): 410-411.
  • 不良事件
    . 2002, 4(4): 270-270.
  • ADE简报
    . 2000, 2(4): 266-266.
  • 不良事件
    . 2005, 7(3): 230-230.
  • 病例报告
    . 2002, 4(6): 406-406.
  • 病例报告
    . 2005, 7(4): 298-299.
  • ADE简报
    . 2001, 3(4): 258-258.
  • 不良事件
    . 2005, 7(5): 390-390.
  • WHO信息
    . 2001, 3(1): 56-56.
  • 安全信息
    . 2007, 9(4): 302-303.
  • ong Zhihui, Xin Zhong, Wang Xinglong, Liu Pengpeng, Wang Jiawei
    Adverse Drug Reactions Journal. 2019, 21(3): 203-207. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.008
    ObjectiveTo explore the changes of blood glucose level after glucocorticoid pulse therapy (GPT) and its influencing factors in patients with Graves ophthalmopathy (GO).MethodsMedical records of GO patients hospitalized in Beijing Tongren Hospital from January 1, 2013 to December 31, 2018 and treated with GPT were collected and retrospectively analyzed. The incidence of glucocorticoid-induced diabetes mellitus (GIDM) during the GPT treatment (3 days) was counted. According to the monitoring data of fasting blood glucose (FBG) and postprandial blood glucose (PBG), the changes of FBG and PBG levels were calculated. Influencing factors for FBG and PBG levels were evaluated by multiple linear stepwise regression analysis.ResultsA total of 75 patients were enrolled in the study, including 44 males and 31 females, aged 22-69 years with the average age of (48±9) years; 40 patients (53.3%) were with normal oral glucose tolerance test, 27 (36.0%) with prediabetes, and 8 (10.7%) with diabetes mellitus; 57 patients (76.0%) were with hyperthyroidism, 11 (14.7%) with hypothyroidism, and 7(9.3%)with normal thyroid function. The peak values of FBG and PBG in 75 patients during GPT treatment were significantly higher than those before the treatment [FBG: (7.9±1.3) vs. (5.3±1.2) mmol/L, PBG: (13.5±2.8) vs. (8.1±2.8) mmol/L;both P<0.001], and the differences were (2.7±1.0) and (5.4±2.6) mmol/L, respectively (P<0.001). Among the 67 patients without diabetes mellitus, 54 (80.6%) developed GIDM during GPT treatment. The levels of FBG and PBG in the 8 patients with diabetes mellitus increased by (2.7±1.4) and (3.7±2.5) mmol/L during GPT treatment, respectively. Multiple linear stepwise regression analysis showed that the influencing factors of FBG level during GPT treatment were baseline FBG level (P<0.001) and history of hyperuricemia (P=0.002) and dyslipidemia (P=0.032); the influencing factors of PBG level were baseline glycosylated hemoglobin A1c (HbA1c, P=0.002) level, baseline PGB level (P=0.024), and serum free thyroxine level (FT4, P=0.021).ConclusionsGPT had a significant effect on blood glucose level in patients with GO, which could lead to higher incidence of GIDM. The main influencing factors of blood glucose level were baseline levels of FBG, PBG, and HbA1c, FT4 levels, and history of hyperuricemia and dyslipidemia.
  • Guo Lijie, Wang Chao, Wang Xiaojing, Zhang Haicong, Ye Lihong
    Adverse Drug Reactions Journal. 2020, 22(2): 62-68. https://doi.org/10.3760/cma.j.issn.1008-5734.2020.02.003
    To explore the clinical and pathological features of drug-induced liver injury (DILI) due to non-steroidal anti?inflammatory drugs (NSAIDs). Methods The medical records of patients with discharged diagnosis of drug-induced liver injury,which were searched from the Hospital Information System of Shijiazhuang Fifth Hospital from January 1, 2013 to December 31, 2016, were collected and analyzed retrospectively. The patients with DILI due to NSAIDs were enrolled into the NSAIDs group and the patients with DILI due to other drugs were enrolled into the control group. The general conditions, results of laboratory tests, and detection results of liver histopathology in patients in the 2 groups were recorded. The score of Roussel Uclaf Causality Assessment Method (RUCAM), clinical type and classification, pathological type and classification, and clinical outcome evaluation of the DILI patients in the 2 groups were performed according to the relevant standards by the members of research team. Results A total of 385 patients were enrolled into the study, including 63 cases in the NSAIDs group and 322 cases in the control group. The differences of sexual distinction, age, and clinical manifestation were not statistically significant (P>0.05 for all). The results of types and severity classification of DILI based on R value showed that the differences of the proportion of patients with different DILI types and classifications between the 2 groups were not statistically significant (P>0.05 for all). Forty one and 142 patients underwent liver biopsy in the NSNIDs group and the control group, respectively. The results of liver biopsy showed that the proportion of patients with type of vascular injury in the NSAIDs group was significantly higher than that in the control group [4.9% (2/41) vs. 0 (0/142), χ2=7.003, P=0.049]; the incidences of inflammation in the portal area and proliferation of bile duct in the NSAIDs group were statistically lower than those in the control group [(63.4%(26/41) vs. 93.7%(133/142), χ2=25.544,P<0.001; 43.9%(18/41) vs. 76.1%(108/142); χ2=15.337,P<0.001]; the incidence of hepatocyte steatosis in the NSAIDs group was significantly higher than that in the control group [22.0% (9/41) vs.9.2% (13/142), χ2=4.925, P=0.026].After drug withdrawal and symptomatic treatments, differences in effective rate and recovery rate between the NSAIDs group and the control group were not statistically significant[88.9% (56/63) vs. 92.5% (298/322); 41.3% (26/63) vs. 52.5% (169/322), P>0.05]. There were no death in both groups. Conclusions The clinical manifestations and clinical outcomes of patients with DILI due to NSAIDs were similar to those due to other drugs. The pathological characteristics of liver were that the incidence of inflammation and proliferation of bile duct in the portal area was lower than that of other drugs, and the incidence of hepatocyte steatosis was higher than that of other drugs. Vascular injury was also observed.
  • Tang Lian, Zhou Mengyue, Zhuang Zhiwei, Lu Jian, Shen Yi, Xu Xiaowen, Zhou Qin, Xue Sudong, Yu Yanxia
    Adverse Drug Reactions Journal. 2019, 21(4): 258-264. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.004
    ObjectiveTo explore the risk factors for coagulation events after argatroban anticoagulation in patients receiving renal replacement therapy (RRT).MethodsThe medical records of patients at high risk of bleeding, who received RRT combined with argatroban anticoagulation in ICU of the Affiliated Suzhou Hospital of Nanjing Medical University (Suzhou Municipal Hospital) from January 2015 to March 2017, were collected and analyzed retrospectively.ResultsA total of 65 patients were enrolled, including 36 males and 29 females, aged (75.4±19.7) years. A total of 372 RRT cycles were performed, including 72 cycles in the coagulation events group because of coagulation events occurence and the remaining 300 cycles in the non-coagulation events group. Univariate logistic regression analysis showed that platelet count (OR=0.990, 95%CI: 0.978-1.001, P=0.084) and serum calcium level at the time of finishing RRT (OR=5.722, 95%CI: 2.183-14.999, P<0.001), first dose (OR=0.712, 95%CI: 0.498-1.017, P=0.062), initial micropump dosage (OR=0.614, 95%CI: 0.368-1.026, P=0.063), and adjusted micropump dosage(OR=0.587, 95%CI: 0.353-0.977, P=0.040) of argatroban, and transmembrane pressure at the time of finishing RRT (OR=1.010, 95%CI: 1.006-1.014, P<0.001) were associated with coagulation events. Multivariate logistic regression analysis showed that serum calcium level and transmembrane pressure at the time of finishing RRT were independent risk factors of coagulation events (OR=4.007, 95%CI: 1.107-15.793, P=0.047; OR=1.012, 95%CI: 1.005-1.018, P=0.008). The ROC curve showed that the risk of coagulation events increased when serum calcium level at the time of finishing RRT was more than 2.6 mmol/L or transmembrane pressure at the time of finishing RRT was more than 206 mmHg.ConclusionSerum calcium level and transmembrane pressure at the time of finishing RRT are independent risk factors of coagulation events after argatroban anticoagulation during RRT.
  • 不良事件
    . 2004, 6(1): 55-55.
  • 不良事件
    . 2003, 5(2): 124-124.
  • 不良事件
    . 2003, 5(2): 121-122.
  • 不良事件
    . 2002, 4(3): 200-201.
  • 不良事件
    . 2002, 4(3): 202-203.
  • 病例报道
    . 1999, 1(2): 120-121.
  • WHO信息
    . 2001, 3(2): 130-130.
  • ADE简报
    . 2001, 3(2): 127-127.
  • 不良事件
    . 2003, 5(1): 58-58.
  • ADE简报
    . 2000, 2(3): 201-201.
  • 病例报告
    . 2002, 4(2): 122-123.
  • 病例报道
    . 1999, 1(1): 52-52.
  • ADE简报
    . 2000, 2(2): 133-133.
  • 不良事件
    . 2004, 6(3): 199-200.
  • Wang Huiyun, Song Shan′ai, Liang Shuya, Xiao Zhongwei, Liang Yu, Zhang Chuantao, Liu Ning, Liu Zimin, Hou Helei
    Adverse Drug Reactions Journal. 2024, 26(12): 743-748. https://doi.org/10.3760/cma.j.cn114015-20240418-00267
    Objective To analyze the clinical characteristics of immune-related psoriasis caused by immune checkpoint inhibitors (ICIs). Methods The patients with newly developed or worsening psoria- sis after ICIs treatment in Department of Oncology, the Affiliated Hospital of Qingdao University from November 2019 to October 2023 were enrolled in this study. The patients′ gender, age, tumor type and stage, usage and dosage of ICIs, drugs applied in combination, history of psoriasis, the time of new onset or deterioration, clinical manifestations, intervention measures and outcomes were collected, and descriptive statistical analysis was performed. Results A total of 13 patients were enrolled in the study, including 10 males and 3 females, with a median age of 66 years. The primary diseases included lung cancer (in 7 patients), gastric cancer (in 5 patients), and cholangiocarcinoma (in 1 patient). The tumor stage was Ⅳ in 12 patients and Ⅲ in 1 patient. Ten patients were treated with programmed cell death 1 receptor (PD-1) inhibitors, 2 with programmed cell death ligand 1 (PD-L1) inhibitors, and one with a PD-1/cytotoxic T-lymphocyte-associated antigen 4 combination antibody. All 13 patients were treated with other anti-tumor drugs at the same time. There were 10 patients with a history of psoriasis and 3 patients with newly developed psoriasis. The median time from the use of ICIs to the onset or deterioration of psoriasis was 54 days. Ten patients were plaque psoriasis and 3 were drip psoriasis. Among the 13 patients, 5, 5, and 3 patients were classified as mild, mode- rate, and severe, respectively. ICIs treatment was suspended in 11 patients and not stopped in 2 patients. After treatment with glucocorticoids, the skin lesions of 13 patients were improved and ICIs were restarted in 3 patients. Conclusions ICIs-related psoriasis usually occurs within 2 months after the use of ICIs. The clinical types are plaque-like and drop-like, mostly mild or moderate. The prognosis is good after discontinuing ICIs or giving glucocorticoids and other drugs. Some patients can restart ICIs treatment.
  • 不良事件
    . 2002, 4(2): 131-131.
  • 不良事件
    . 2005, 7(1): 66-66.
  • 不良事件
    . 2002, 4(4): 271-271.
  • WHO信息
    . 2001, 3(1): 55-55.
  • ADR咨询
    . 2003, 5(2): 136-136.
  • ADR咨询
    . 1999, 1(3): 168-168.
  • 安全信息
    . 2009, 11(5): 377-2.
  • Shi Chunhuan, Wang Weibo, Li Zhenqing, Wang Jimei, Zhang Yonggang, Zhang Cuifang
    Adverse Drug Reactions Journal. 2019, 21(6): 453-454. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.014
    A 48-year-old male patient received oral hydroxychloroquine 100 mg thrice daily, oral total glucosides of white paeony 60 mg twice daily, and intravenous infusion of methylprednisolone 40 mg once daily, which was replaced by oral prednisone 45 mg once daily 10 days later. The electrocardiogram of the patient was normal before the medication. On day 11 of medication, the patient developed palpitation about 2 hours after taking hydroxychloroquine. His electrocardiogram showed atrioventricular block, which returned to normal about 2 hours later. Then the patient was monitored by dynamic electrocardiogram. On day 17, the patient developed palpitation again about 2 hours after taking hydroxychloroquine and the dynamic electrocardiogram showed atrioventricular block, atrial premature beat, and occasional premature ventricular beat. These symptoms were considered to be related to hydroxychloroquine. Then hydroxychloro-quine was discontinued and other drugs were continued. Metoprolol sustained-release tablets 23.75 mg were given once daily. On day 3 of hydroxychloroquine withdrawal, the patient had normal electrocardiogram. At 9 days of follow-up, palpitation and atrioventricular block did not recur.
  • Yu Pingzi, Chen Zeyu, Li Weize, Lin Shu, Yang Fan
    Adverse Drug Reactions Journal. 2019, 21(6): 480-481. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.028
    A 51-year-old male patient took by himself oral compound aminopyrine phenacetin tablets (each tablet containing aminopyrine 150 mg, phenacetin 150 mg, caffeine 50 mg, and phenobarbital 15 mg) 2 tablets twice daily for headache. On the second day, the patient developed erythematous rash all over the body, accompanied by obvious itching and pain. Then the compound aminopyrine phenacetin tablets were stopped. On the third day, some of the macula fused into a piece, on which different sizes of loose blisters or bullae appeared. And erosion occurred at the junction of the skin and mucous of the mouth and genitals. Intravenous infusions of methylprednisolone and calcium gluconate injection, oral ebastine tablets and ketotifen fumarate tablets, and skin care were given. Six days later, his rash became lighter, most of the blisters and bullae dried up and scabbed. The dose of methylprednisolone was gradually reduced. Eleven days later, the erythema obviously improved, blisters and bullae dried up, and flaky desquamation on the epidermis occurred. Intravenous infusion of methylprednisolone was changed to oral prednisolone (20 mg/d). Thirteen days later, the rash subsided basically.
  • Zhang Yan, Hu Linkun, Gao Jie
    Adverse Drug Reactions Journal. 2019, 21(5): 382-384. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.014
    A 56-year-old female patient received triple-drug immunosuppressive therapy after allogenic renal transplantation, including tacrolimus 3 mg twice daily, mycophenolate mofetil 500 mg twice daily, and prednisone 20 mg once daily. The patient received compound sulfamethoxazole 0.48 g once daily for prevention of infection a month after operation. The laboratory tests showed that the levels of tacrolimus blood concentration (CTac), serum creatinine (Scr), and blood potassium were 6.56 μg/L, 142 μmol/L, and 4.3 mmol/L, respectively before medication, 12.13 μg/L, 147 μmol/L, and 7.1 mmol/L after 1 week of compound sulfamethoxazole treatment, and 16.72 μg/L, 176 μmol/L, and 8.3 mmol/L after 2 weeks, accompanied by lassitude and weakness of the feet. Compound sulfamethoxazole was stopped, potassium-lowering therapy was given, the dose of tacrolimus was reduced to 2 mg twice daily, and mycophenolate mofetil and prednisone were given at the same doses as before. Laboratory tests showed Scr 175 μmol/L and blood potassium 4.7 mmol/L on day 3 of compound sulfamethoxazole withdrawal and CTac 7.13 μg/L, Scr 150 μmol/L, and blood potassium 4.8 mmol/L on day 8. The patient took compound sulfamethoxazole 0.48 g twice daily again according to the doctor′s advice, and 2 weeks later, her blood potassium increased to 6.2 mmol/L. The dose of compound sulfamethoxazole was gradually reduced firstly to 0.48 g once daily, then to 0.48 g every other day, and was completely stopped 8 weeks later. Two weeks after drug withdrawal, her blood potassium decreased to 4.6 mmol/L. Hyperkalemia did not recur.
  • Wu Xiaoyan, Zhang Helen, Cai Haodong
    Adverse Drug Reactions Journal. 2018, 20(6): 436-441. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.07.008
    In the developed countries such as the United States, Canada, and Australia, phar-macists play an important role not only in pharmacy services, but also in immunization and vaccine management. The American Pharmacists Association (APhA) has been training pharmacists in vaccine management since 1994. The American Hospital Pharmacist Association formulated the guidelines on the pharmacist′s role in immunization in 2003. Since then, the pharmacists began to involve in procurement, distribution, prescription, and immunization of vaccine. In recent years, the pharmacists in France, Australia, Canada, and other countries have been involving in immunization and vaccine management in succession, and even playing an important role in all aspects of vaccine management (such as procurement, storage, prescription and dispensing, vaccine consultation, immunization, vaccine adverse events reporting, public health education, and etc.). The experience of foreign pharmacists participating in immunization is worth learning.
  • ADE简报
    . 2001, 3(2): 126-126.
  • 病例报道
    . 1999, 1(2): 118-119.
  • Wang Fei, Liu Gang, Yin Zhuolin, Zhang Yan
    Adverse Drug Reactions Journal. 2023, 25(6): 374-375. https://doi.org/10.3760/cma.j.cn114015-20220420-00339
    A 23-year-old male patient with progressive muscular dystrophy received intravenous injection of levocarnitine 1 g twice daily. Before the medication, the patient′s blood pressure was 120/70-mmHg. After 15-minutes of the first administration, the patient′s blood pressure increased to 156/90-mmHg, accompanied by chest tightness and headache; 4 hours later, it increased to 196/138-mmHg; 12-hours later, it decreased to 158/106-mmHg. After the second intravenous injection of levocarnitine on the same day, the elevation of blood pressure recurred. The elevation of blood pressure was considered to be caused by levocarnitine. The drug was discontinued the next day, and the patient′s blood pressure gradually returned to the reference range. Thereafter, the patient did not experience any symptoms such as elevated blood pressure, chest tightness, or headache.
  • Sun Hongling
    Adverse Drug Reactions Journal. 2024, 26(1): 53-55. https://doi.org/10.3760/cma.j.cn114015-20230727-00559
    A 61-year-old male patient with advanced prostate cancer and bone marrow metastases was treated with olaparil after the ineffective effect of various anti-tumor regimens. The patient had stable disease condition and was well tolerated to olaparib treatment. Five months later, the patient developed low-grade fever, cough, chest tightness, and shortness of breath. Laboratory tests showed eosinophil count 0.85×109/L and eosinophil ratio 0.08. Chest CT scan revealed bronchitis in both lungs with inflammation in the upper lobe of left lung. After treatments of anti-infection and tracheal dilation, the symptoms were not relieved, and chest CT re-examination showed slightly enlarged and increased inflammation of left lung, interstitial inflammatory, and organizing pneumonia in both lungs. Alveolar lavage fluid cytology showed an elevation of eosinophils. Considering the possibility of olaparil-induced eosinophilic pneumonia, olaparib was discontinued, and intravenous infusion of methylprednisolone 40-mg once daily and appropriate anti- infection therapy was given. After that, the patient did not have fever, and symptoms of cough, chest tightness, and shortness of breath were relieved. One week later, methylprednisolone was discontinued. Fever recurred and above respiratory symptoms were aggravated the next day. Methylprednisolone was re-given. The patient did not have fever, and symptoms such as cough, chest tightness, and shortness of breath were relieved. After 7 days, the chest CT scan showed that the interstitial inflammation in lungs was obviously improved.
  • WHO信息
    . 2001, 3(2): 128-128.
  • WHO信息
    . 2003, 5(5): 352-352.
  • 不良事件
    . 2002, 4(2): 129-130.
  • 不良事件
    . 2005, 7(3): 232-232.
  • 不良事件
    . 2004, 6(5): 346-346.
  • Wang Xin, Wang Shihui, Wang Yingkai, Cui Xiangli
    Adverse Drug Reactions Journal. 2019, 21(6): 477-478. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.026
    A 49-year-old female patient received anticoagulation therapy with rivaroxaban due to pulmonary embolism (initial dose: 15 mg, twice daily; maintenance dose 3 weeks later: 20 mg, once daily). From the month of treatment, the patient′s menstrual volume increased and menstrual period extended from 4-5 days to 8-9 days. Five months later, she developed anemia, with hemoglobin (Hb) 53 g/L. Uterine bleeding was considered to be related to rivaroxaban. Rivaroxaban was stopped, oxytocin and blood transfusion were given, and her anemia was improved. But 2 weeks later, pulmonary embolism recurred in the patient. Low-molecular-weight heparin and enoxaparin were given and 7 days later, enoxaparin was gradually adjusted to warfarin therapy (4.5 mg/d). The symptoms of chest tightness and short of breath were improved and anemia was Hb 125 g/L. After discharge, warfarin was taken continuously. At 1 month of follow-up, her INR was maintained at 2.00-3.33 and menstruation returned to normal.
  • Liu Xueli, Zheng Liying, Hu Xin, et al
    Adverse Drug Reactions Journal. 2019, 21(6): 425-430. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.005
    International Research Center for Medicinal Administrations, Peking University, Beijing 100191, China; Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing 100191, China; Department of Pharmacy, Beijing Hospital, National Center of Gerontology, Institute of Geriatrics, Chinese Academy of Medical Sciences, Beijing 100730, China; et al
  • Han Mei, Ge Ming, Lei Bingtuan, Yang Huibo
    Adverse Drug Reactions Journal. 2019, 21(2): 142-144. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.014
    Two male patients (patient 1, 54 years old; patient 2, 63 years old) were treated with apatinib mesylate tablets (apatinib) for adenocarcinoma of cardia and gastric fundus and left lung cancer, respectively. Patient 1 developed erythema and swelling on the extremities, perianal, and perigenital on day 22 after taking apatinib (850 mg/d). Apatinib-induced hand-foot skin reaction (HFSR) was considered. Then apatinib was discontinued, oral vitamin B6 and topical external vitamin E cream were given. After withdrawal of apatinib, his skin symptoms alleviated,  and apatinib (750 mg/d) was re-given on day 7 after withdrawal. On day 57 after the resumption of apatinib, the patient′s skin symptoms worsened and the medication was discontinued again. Afterwards, apatinib was given and then discontinued for 2 times (first 500 mg/d and then 250 mg/d). Because the symptoms aggravated after medication and alleviated after discontinuation, apatinib treatment was terminated finally. Patient 2 developed skin erythema, swelling, and pain on the palms and soles on day 35 after apatinib treatment at a dose of 500 mg/d. On day 85, he developed skin desquamation and circular keratosis of hands and feet, scattered erythema with desquamation in axilla, perianal region and groin, and increased pain in the skin lesions. Apatinib-induced HFSR was diagnosed. Apatinib was discontinued and symptomatic treatments were given. On day 17 of drug withdrawal, his skin symptoms improved and apatinib (500 mg/d) was given again. About 2 weeks later, the patient′s skin symptoms aggravated again, and the drug was discontinued.
  • ADR咨询
    . 2002, 4(1): 63-63.
  • 会议纪要
    . 2011, 13(3): 201-3.
  • 安全信息
    . 2010, 12(5): 374-2.
  • ADE简报
    . 1999, 1(3): 190-191.
  • Liu Bo, Zhou Xingzhuo, Zheng Lin, Li Mingchun, Wang Chunyan
    Adverse Drug Reactions Journal. 2019, 21(2): 152-154. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.019
    An 18-year-old male patient developed numbness and fatigue in the limbs without any obvious causes, which aggravated to be unable to hold objects in hands, have difficulty in writing, standing and walking, and be easy to fall after 3 weeks. Laboratory tests showed his average erythrocyte volume 104 fl, homocysteine 89.1 μmol/L, vitamin B12 76 pmol/ml, and folic acid 14.9 nmol/L. MRI revealed image features of subacute combined degeneration of spinal cord. Nerve conduction velocity, action potential, and electromyography showed nerve damage signs. He was diagnosed with toxic myelopathy, subacute combined degeneration of spinal cord, and peripheral neuropathy. To find the cause of the disease, the doctor asked about the medical history repeatedly, and finally learned that the patient had taken nitrous oxide(N2O) for nearly 6 months(8-50 g/d). An IV injection of mecobalamine (0.5 mg, once daily), intramuscular injection of rat nerve growth factor (30 μg, once daily), as well as massage and acupuncture treatments were given. After 8 days, his average erythrocyte volume was 102 fl, homocysteine was 12.9 μmol/L, vitamin B12 was >1 500 pmol/ml, and folic acid was 14.1 nmol/L. After 3 weeks, numbness and fatigue of his upper limbs disappeared. After 3 months, the patient could walk up and down the hill and run.
  • Zhang Yingpei, Wu Dongfang
    Adverse Drug Reactions Journal. 2019, 21(6): 459-460. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.017
    A 46-year-old female patient with gastric high-grade B-cell lymphoma received CHOP chemotherapy (IV infusions of epirubicin 120 mg, cyclophosphamide 1 200 mg, and vindesine 2 mg on day 1; oral prednisolone tablets 100 mg on days 1 to 5). Before the chemotherapy, her cardiac function was grade Ⅱ and her routine blood parameters and coagulation function were normal. On the 3rd day of chemotherapy, the patient had a transient afibrinogenemia followed by heart failure, extensive myocardial infarction, and severe myelosuppression (white blood cell count 1.65×109/L, neutrophil percentage 0.85, and platelet count 57×109/L). Despite active treatments, the patient died on the 11th day of the chemotherapy.
  • He Yayi, Shi Bingyin
    Adverse Drug Reactions Journal. 2019, 21(5): 366-371. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.010
    ObjectiveTo explore the clinical characteristics of Graves′disease patients with methimazole-induced agranulocytosis combined with septicemia.MethodsThe study was based on a previous retrospective analysis of the clinical data in Graves′ disease patients admitted to the First Affiliated Hospital of Xi′an Jiaotong University from January 2000 to December 2015 due to antithyroid drug-induced agranulocytosis and focused on the 7 patients who developed agranulocytosis combined with septicemia (septicemia group) after taking methimazole. Relevant data was re-extracted from the medical records of the 7 patients. The clinical characteristics of patients with septicemia were explored through the analysis on their clinical manifestations, bacteriological characteristics, treatment and outcomes, and the comparison of above contents with those of the 55 patients with methimazole-induced agranulocytosis without septicemia (non-septicemia group). ResultsSeven patients in the septicemia group were female, aged 20 to 56 years. Of the 7 patients, 3 combined with hyperthyroid heart disease, 1  combined with life-threatening thyrotoxicosis; 6 patients with multiple organ infections (2 with suppurative tonsillitis and pulmonary infection; 2 with suppurative tonsillitis and gastrointestinal infection; 1 with suppurative tonsillitis, pulmonary infection, and submandibular abscess; 1 with suppurative tonsillitis, pulmonary infection, and periodontal abscess) and 1 patient with pulmonary infection alone. The main clinical symptoms of patients with septicemia included fever, sore throat, anorexia, and palpitations. The proportions of patients with suppurative tonsillitis, lung infections, and the lowest absolute neutrophil count (ANC) value of 0 in the septicemia group were higher than those in the non-septicemia group [6/7 vs. 43.6% (24/55), 5/7 vs. 21.8% (12/55), and 5/7 vs. 29.1% (16/55)]. The minimum white blood cell count in patients in the septicemia group was significantly lower than those in the non-septicemia group[0.23 (0.17, 0.60)×109/L vs. 0.92 (0.50, 1.47)×109/L]. The duration of fever, recovery time of agranulocytosis, and hospitalization days in patients in the septicemia group were significantly longer than those in the non-septicemia group [13 (7, 21) d vs. 6(3, 9) d and 29 (17, 37) d vs. 14 (9, 21) d]. The differences were all statistically significant (P<0.05 or P<0.01). After the diagnosis of agranulocytosis, methimazole was stopped in all patients. Their septicemia was effectively controlled and ANC returned to normal after the treatments with broad-spectrum antibiotics, recombinant human colony-stimulating factor (rhG-CSF), and glucocorticoids.ConclusionsGraves′disease patients, who developed agranulocytosis combined with septicemia after taking methimazole, often had multiple organ infections. Their clinical symptoms were critical and difficult to treat. The early and rational application of broad-spectrum antibacterial drugs and simultaneous treatments with rhG-CSF and glucocorticoids were expected to improve patients′outcomes.
  • WHO信息
    . 2001, 3(1): 57-57.
  • ADE简报
    . 2001, 3(1): 51-51.
  • 不良事件
    . 2005, 7(4): 307-308.
  • 不良事件
    . 2002, 4(6): 414-414.
  • WHO信息
    . 2002, 4(2): 136-136.
  • Su Yingying
    Adverse Drug Reactions Journal. 2023, 25(6): 324-326. https://doi.org/10.3760/cma.j.cn114015-20230103-01205
    Phenobarbital is a centennial drug for the treatment of status epilepticus. It has the advantages of high termination rate and low recurrence rate of seizure, but it also has adverse reactions such as respiratory depression and blood pressure decline. The results of 2 RCT in China in 2016 and 2021 suggest that scientific and reasonable improvement of phenobarbital medication scheme can give full play to drug effectiveness on the basis of improving safety. The latest research results of this old drug not only provide evidence-based basis for the development of expert consensus and guidelines, but also maximize the benefits for countries or regions that cannot market new antiepileptic drugs, as well as families and individuals who cannot bear the cost of new antiepileptic drugs.
  • Guo Wenbin, Wang Tingting, Liu Qingyue, Wei Xinhong
    Adverse Drug Reactions Journal. 2024, 26(10): 638-640. https://doi.org/10.3760/cma.j.cn114015-20240122-00056
    A 44-year-old female patient was treated with norethisterone 5 mg once every 8 hours due to atypical hyperplasia of endometrium. One month later, the patient developed asthma with cyanosis, and sudden cardiac arrest later. According to the results of electrocardiogram and echocardiogram examination, acute pulmonary embolism with cardiac arrest was diagnosed. Cardiac resuscitation was immediately implemented, and thrombolysis and anticoagulation therapies were performed, accompanied by veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for life support. After 5 minutes of thrombolytic therapy, the patient′s heart beat and blood pressure gradually recovered. The results of pulmonary artery CT angiography supported the diagnosis of acute pulmonary embolism and effectiveness of thrombolysis. After 31 hours of thrombolytic therapy, the patient has stabilized vital signs and VA-ECMO was removed. After 47 hours of thrombolytic therapy, the patient′s consciousness fully recovered, the tracheal tube was removed, and anticoagulant therapy was continued. After 11 days of thrombolytic therapy, the echocardiography was re-performed, showing normal pulmonary artery pressure, and the exercise tolerance was checked to be good. At 1 month of follow-up, the cardiac function and structure were normal on echocardiography, no thrombus was found on lower limb vascular ultrasound.
  • Shen Li, Pan Hong
    Adverse Drug Reactions Journal. 2024, 26(2): 121-123. https://doi.org/10.3760/cma.j.cn114015-20230628-00476
    A 51-year-old female patient received an IV infusion of toripalimab 240-mg once every 3 weeks after malignant melanoma resection of the left toe. On the 18th-21st day after the 6th cycle of medication, the patient presented with notable swelling in her legs and face successively. On the 28th day after the 6th cycle of medication, laboratory tests showed serum creatinine (Scr) 186-μmol/L, creatine kinase (CK) 4-038-U/L, CK-MB 52-U/L, lactate dehydrogenase (LDH) 1-034-U/L, alanine aminotransferase (ALT) 202-U/L, aspartate aminotransferase (AST) 269-U/L, and urinary occult blood (++). Toripalimab-induced rhabdomyolysis was considered. After 15 days of treatments with methylprednisolone, human immunoglobulin, fluid replacement, and alkaline urine, the swelling in the patient′s legs and face were improved, and laboratory tests showed CK 2-132-U/L, CK-MB 32-U/L, ALT 73-U/L, AST 47-U/L, and Scr 70-μmol/L; after 22 days of treatments, the swelling disappeared,  and laboratory tests showed CK 1-804-U/L, CK-MB 33-U/L, ALT 66-U/L, and AST 41-U/L.
  • Yu Tingting, Si Zhizhen, Lyu Shuyun, Zhou Jin, Sun Ying
    Adverse Drug Reactions Journal. 2024, 26(5): 312-314. https://doi.org/10.3760/cma.j.cn114015-20230923-00704
    A 58-year-old female patient without disease history of diabetes mellitus was enrolled in the phase Ⅲ clinical trial of alpelisib combined with fulvestrant due to ineffective treatment of stage Ⅳ breast cancer. The treatment regimen was alpelisib tablets 300-mg orally once daily and fulvestrant injection 500-mg once a month intramuscularly. One month later, the patient experienced symptoms such as poor appetite, nausea, vomiting, drowsiness, and blurred consciousness. Laboratory tests showed arterial blood pH 7.1, random blood glucose >34.7-mmol/L, serum creatinine 210-μmmol/L, blood potassium 3.00-mmol/L, blood sodium 129-mmol/L, and urine ketone body (++). Diabetic ketoacidosis was diagnosed, and treatments such as intravenous insulin supplementation, rehydration, and correction of acidosis and electrolyte disorders were given. After 5 days, the patient′s symptoms were improved, but the blood glucose was poor controlled. Diabetic ketoacidosis was considered to be related to alpelisib. The dose of alpelisib was reduced by half, oral hypoglycemic drugs were added, and the insulin regimen was adjusted. Later, the blood glucose was relatively well controlled, and urinary ketone bodies turned negative.
  • Jing Shen'ao, Qiu Shengnan, Li Chenghao, Huang Xin
    Adverse Drug Reactions Journal. 2024, 26(8): 480-486. https://doi.org/10.3760/cma.j.cn114015‑20240305‑00131
    Objective To understand the clinical characteristics of hemophagocytic lymphohistiocytosis (HLH) induced by immune checkpoint inhibitors (ICIs). Methods Relevant databases at home and abroad (up to February 15, 2024) were searched and case reports of HLH induced by ICIs were collected. Relevant information of patients (gender, age, primary disease), usage and dosage of ICI, combined drugs, occurrence time, clinical manifestations, management, and outcomes of HLH were extracted and analyzed descriptively and statistically. Results A total of 37 case reports were enrolled in the analysis, involving 44 patients. Of them, 26 patients were male and 18 were female. The age ranged from 2 to 86 years, with a median age of 67 years. The primary diseases included melanoma in 14 patients, lung cancer in 12 patients, kidney cancer in 4 patients, oral squamous cell carcinoma and acute myeloid leukemia in 2 patients each, and other 10 malignant tumors in one patient each. A total of 8 ICIs were used, including pembrolizumab in 17 patients, nivolumab in 10 patients, nivolumab combined with ipilimumab in 8 patients, atezolizumab, camrelizumab, and ipilimumab in 2 patients each, and toripalimab, tislelizumab, and avelumab in 1 patient each. Among them, 33 patients received single ICI immunotherapy, 6 patients received immunotherapy combined with targeted therapy, and 5 patients received immunotherapy combined with chemotherapy. Twenty-two patients had medication dosage records, and the administration method was all intravenous infusion. The shortest time for HLH occurrence was 1 day after medication, the longest was 8 months, and the median time was 5 days. The clinical manifestations included recurrent fever, fatigue, loss of appetite, etc. Laboratory and auxiliary examinations showed decreased blood cells, elevated ferritin, increased hemophagocytic cells, and spleen enlargement. After the diagnosis of HLH, 40 cases discontinued the drug, 1 did not stop, and 3 were unknown. Forty?two patients received symptomatic treatments, of which 18 patients returned to normal, 17 patients were improved, 1 patient was unknown, and 6 patients died. Two patients who did not receive intervention died. Conclusions The main clinical symptoms of ICI?related HLH are fever, fatigue, weakness, loss of appetite, and hemophagocytosis. Withdrawal and symptomatic treatments can effectively improve the symptoms of patients, but HLH has a higher risk of death.

  • 不良事件
    . 2004, 6(2): 131-131.
  • 不良事件
    . 2003, 5(5): 347-348.
  • 不良事件
    . 2002, 4(4): 270-270.
  • 不良事件
    . 2003, 5(6): 414-414.
  • WHO信息
    . 2002, 4(5): 351-351.
  • 不良事件
    . 2002, 4(5): 344-345.
  • Zhang Yueli, Qin Wangjun, Deng Ang
    Adverse Drug Reactions Journal. 2018, 20(6): 446-447. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.011
    An 81-year-old male patient received an IV infusion of zoledronic acid 4 mg once monthly for prostate cancer with bone metastasis in a local hospital. After 31 times of administration, the medication was given once every 3 months and after 3 times of treatment, the drug was stopped. The total accumulated dose of zoledronic acid was 136 mg. Two months after drug withdrawal, the patient developed pain in the left upper jaw when chewing food. He was diagnosed with endodontitis and 4 times of arrachement was performed in the local hospital. After the last operation, the wound did not heal with local pyorrhea and pain. The CT examination in China-Japan Friendship Hospital showed the osteonecrosis of left maxilla, which was considered to be related to zoledronic acid. Intravenous infusion of cefuroxime sodium 1.5 g and metronidazole 0.5 g twice daily, and gargle with 0.02% chlorhexidine acetate solution 20 ml thrice daily were given. The patient underwent debridement of infection focus in left maxilla. The medications after the operation were as the same as before, except adding regional rinsing with 0.9% sodium chloride injection. On day 4 after operation, the local inflammation in left maxilla improved and 3 weeks later, the wound healed.
  • Chen Di, Zhao Ming, Liang Liang, Zhu Yuanchao, Yang Liping
    Adverse Drug Reactions Journal. 2018, 20(6): 419-425. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.005
    ObjectiveTo analyze the relationship between glutathione S-transferase P1 (GSTP1) 313A>G polymorphism and the adverse reactions induced by cyclophosphamide (CP).MethodsThe clinical research literature about the relationship between GSTP1 313A>G polymorphism and the adverse reactions induced by CP were collected from related domestic and foreign databases up to July, 2017. The quality of the literature was evaluated by STREGA criterion. The meta-analysis was conducted by RevMan 5.2 software and the results were expressed as relative risk (RR) and 95% confidence interval (CI).ResultsA total of 7 articles were included in the meta-analysis and their quality evaluation results were reliable (all scores≥3), involving 1 305 patients. The results of meta-analysis showed that the differences of incidence of  leukopenia, neutropenia, anemia, thrombocytopenia, myelosuppression, and infection after the treatments of CP combined with other chemotherapeutics between the patients with GSTP1 313A>G AA genotype and GSTP1 313A>G AG/GG genotype were not statistically significant (P>0.05 for all); the incidence of gastrointestinal reactions in patients with GSTP1 313A>G AA genotype was significantly lower than that in patients with GSTP1 313A>AG/GG genotype (RR=0.46, 95%CI: 0.22-0.97, P=0.004); the incidence of myelosuppression after the treatment of CP alone in patients with GSTP1 313A>G AA genotype was significantly lower than that in patients with GSTP1 313A>G AG/GG genotype (RR=0.27, 95%CI: 0.08-0.91, P=0.03).ConclusionThe gastrointestinal reactions induced by CP combined with other chemotherapeutics and myelosuppression induced by CP alone may be related to the polymorphism of GSTP1 313A>G.
  • Lin Zhiqiang, Wu Ruihong, Xiao Jianxiong, Zhou Yong, Zhang Shanying, Zheng Kuicheng
    Adverse Drug Reactions Journal. 2019, 21(5): 353-359. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.008
    ObjectiveTo evaluate the safety of national immunization program (NIP) vaccines and non-NIP vaccines in Fujian Province from 2011 to 2015.MethodsThe adverse events following immunization (AEFI) case information reported in Fujian Province from 2011 to 2015 was collected from the National AEFI Information Management System and vaccination data of NIP vaccines (11 species) and non-NIP vaccines (19 species) in the same period in Fujian Province were collected from the National Immunization Program Information Management System. The collected monitoring data were descriptively analyzed. The total and severe AEFI reporting rates and their 95% confidence intervals (CI) were calculated.ResultsFrom 2011 to 2015, a total of 70 976 300 doses of vaccines were inoculated in Fujian Province and a total of 8 987 cases of AEFI were reported, including 192 cases (2.14%) of severe AEFI. The incidence (95%CI) of reported AEFI was 12.66 (12.40-12.93) per 100 000 doses and the incidence (95%CI) of reported severe AEFI was 2.71 (2.34-3.12) per one million doses. A total of 55 702 100 doses of NIP vaccines were inoculated and 7 347 cases of AEFI were reported, of which 138 (1.88%) were severe AEFI cases. The incidence (95%CI) of reported AEFI was 13.19 (12.89-1.49) per 100 000 doses of NIP vaccines and the incidence (95%CI) of reported severe AEFI was 2.48 (2.08-2.93) per one million doses. Among the 11 NIP vaccines, the incidence (95%CI) of reported AEFI ranged from 0.95 (0.88-1.13) per 100 000 doses to 43.71 (40.72-46.75) per 100 000 doses and the incidence (95%CI) of reported severe AEFI ranged from 1.04 (0.32-1.76) per one million doses to 6.41 (2.78-10.04) per one million doses. A total of 15 271 600 doses of non-NIP vaccines were inoculated and 1 640 cases of AEFI were reported, of which 54 (3.54%) were severe AEFI cases. The total incidence (95%CI) of reported AEFI was 10.74 (10.23-11.27) per 100 000 doses and the incidence (95%CI) of reported severe AEFI was 3.54 (2.66-4.61) per one million doses. Among the 19 non-NIP vaccines, the incidence (95%CI) of reported AEFI ranged from 2.06 (0.38-3.71) per 100 000 doses to 45.22 (35.29-55.10) per 100 000 doses and the incidence (95%CI) of reported severe AEFI ranged from 0.52 (0-1.53) per one million doses to 20.89 (0-44.51) per one million doses.ConclusionFrom 2011 to 2015, the incidences of reported AEFI and severe AEFI for NIP and non-NIP vaccines circulated in Fujian Province were low, which had good safety.
  • Liu Haiyan, Song Yanqing, Ke Wei, Wang Xiangfeng
    Adverse Drug Reactions Journal. 2019, 21(4): 307-308. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.018
    A 74-year-old male patient received an IV infusion of lansoprazole for injection 30 mg twice daily because of gastric cancer accompanied by gastrointestinal hemorrhage. On day 16 of medication, he developed hypourocrinia and laboratory tests showed urea nitrogen 24.5 mmol/L, serum creatinine (Scr) 254 μmol/L, and estimated glomerular filtration rate (eGFR) 23.0 ml/(min·1.73m2). On day 17 of medication, rashes appeared on his back, abdomen, and thigh root. Laboratory tests showed urea nitrogen 30.5 mmol/L, Scr 463 μmol/L, eGFR 11.5 ml/(min·1.73m2), and positive urinary protein (+++). Kidney biopsy showed a large number of lymphocytes infiltration in the renal interstitium. Acute interstitial nephritis was diagnosed, which was considered to be related to lansoprazole for injection. Lansoprazole for injection was stopped and the symptomatic therapy was given. On day 12 of drug withdrawal, the rashes disappeared and laboratory tests showed urea nitrogen 6.9 mmol/L, Scr 127 μmol/L, eGFR 57.6 ml/(min·1.73m2), and negative urinary protein.
  • Cai Xueying, Zeng Huiqing, Chen Xiaorong, Chen Xiangxing, Zhu Sihong, Huang Yemei
    Adverse Drug Reactions Journal. 2019, 21(6): 449-451. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.012
    A 53-year-old female patient with advanced lung cancer, who was negative for all types of driving genes, received apatinib mesylate tablets(apatinib) 500 mg/d orally after 2 cycles of ineffective chemotherapy of pemetrexed disodium plus cisplatin (21 days as 1 cycle). After 22 days of medication, apatinib was reduced to 250 mg/d because of the hand-foot skin reactions. After 7 months of treatment with apatinib, the pulmonary neoplasms shrank, but the patient developed shortness of breath. CT examination showed bilateral pulmonary interstitial fibrosis. Apatinib was discontinued and hormone therapy was given. The patient′s symptoms were progressively aggravated. On day 32 of drug discontinuation, CT scan showed that the pulmonary interstitial fibrosis was aggravated and the patient developed typeⅠrespiratory failure. An IV infusion of methylprednisolone 500 mg/d and oxygen inhalation were given. However, the patient′s condition was still deteriorating. On day 37 of drug discontinuation, the patient died.
  • Tian Dongdong, Wu Huizhen, He Lien, Qiu Zhihong
    Adverse Drug Reactions Journal. 2019, 21(6): 471-472. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.023
    Fundus fluorescein angiography was performed in the 2 ophthalmic outpatients (patient 1, a 61-year-old female with ischemic optic neuropathy; patient 2, a 63-year-old male with vitreous hemorrhage in the right eye) after exclusion of contraindications and signing of informed consent. Both of them had no history of drug allergy and heart disease, and their liver and kidney functions were normal. Before angiography, allergy tests were performed by intravenous injection of fluorescein sodium diluent. After 5 minutes of observation, the test results in the 2 patients were all negative. Then fluorescein sodium injections were given intravenously. The 2 patients developed anaphylactic shock about 2 minutes and 17 minutes after injections. Their blood pressure decreased to 50/32 mmHg and 49/36 mmHg, respectively. The patient 1 had transient atrial fibrillation and the patient 2 once had a heart rate of 0. After anti-allergic and antishock therapy, the blood pressure and heart rate in the 2 patients gradually returned to normal.
  • ADR咨询
    . 2002, 4(1): 63-63.
  • 不良事件
    . 2002, 4(1): 53-53.
  • 不良事件
    . 2005, 7(4): 271-271.
  • Liu Shujuan, Cai Wei, Yuan Binbin, Li Xin, Shao Feng
    Adverse Drug Reactions Journal. 2025, 27(2): 126-128. https://doi.org/10.3760/cma.j.cn114015-20240318-00166
    A 70-year-old female patient with tumor in the neck and body of the pancreas received 11 cycles of chemotherapy with paclitaxel and gemcitabine. Due to disease progression, she subsequently underwent chemotherapy of fluorouracil, calcium folinate, and irinotecan, combined with immunotherapy of serplulimab. After 28 days (only one session of immunotherapy), the patient developed drooping of the right upper eyelid and chest tightness, followed by pain in the middle and lower segments of the sternum and radiating pain to the throat, accompanied by speech difficulties, dysphagia, and chest tightness and wheezing. Laboratory tests indicated hypersensitive troponin T 0.551 μg/L, creatine kinase (CK) 3 426 U/L, CK-MB 176 μg/L, and myoglobin 1 702 μg/L. The imaging examination of head and neck ruled out intracranial lesions, while the electrocardiogram suggested myocardial damage. Immune-related myocarditis with myositis and/or myasthenia gravis overlap syndrome (IM3OS) induced by serplulimab was considered. Immunotherapy was temporarily halted, and treatments with methyprednisolone and human immunoglobulin were administered. Sixteen days later, clinical symptoms of IM3OS in the patient were improved, with laboratory tests showing hypersensitive troponin I 0.075 μg/L, CK 216 U/L, CK-MB 58 μg/L, and myoglobin 273 μg/L. Upon follow-up, the patient switched to monotherapy with irinotecan alone or combined with raltitrexed for cancer treatment, clinical symptoms of IM3OS did not recur, and no abnormalities were observed in myocardial injury markers or muscle enzymes.
  • 不良事件
    . 2004, 6(3): 198-199.
  • 药物安全动态
    . 2006, 8(2): 152-153.
  • WHO信息
    . 2002, 4(2): 135-136.
  • 不良事件
    . 2003, 5(3): 197-197.
  • Liu Jue, Li Menghua, Yang Ping, Wu Liming
    Adverse Drug Reactions Journal. 2018, 20(6): 454-456. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.015
    A 51-year-old male patient with renal failure received IV infusions of vancomycin 1.0 g and cefoperazone sodium and sulbactam sodium 2.0 g twice daily for 7 days in a local hospital because of methicillin-resistant staphylococcus aureus infection. On day 22 of drug withdrawal, the patient developed edematous erythema on his face and lower limbs; on day 26 of drug withdrawal, he developed fever and the laboratory tests showed white blood cell (WBC) 19.7×109/L, neutrophile granulocyte 0.67, eosinophile granulocyte 0.16, C reactive protein (CRP) 76.5 mg/L, procalcitonin 10.9 μg/L, alanine aminotrans-ferase (ALT) 68 U/L, alkaline phosphatase (ALP) 452 U/L, γ-glutamyltransferase (γ-GT) 118 U/L, serum creatinine (Scr) 1 323.5 μmol/L, and prothrombin time (PT) 53.5 s. He was treated with IV infusions of methylprednisolone and the above two drugs again in the local hospital. Six days after remedication, his erythema merged and spread to the whole body, which accompanied by systemic desquamation and skin ulcers on his dorsal foot and around the mouth. Then the patient was transferred to the First People′s Hospital of Hangzhou and diagnosed as drug hypersensitivity syndrome, which was considered to be related to the concomitant use of vancomycin and cefoperazone sodium and sulbactam sodium. Symptomatic and supportive treatments were given, including IV infusions of piperacillin sodium and tazobactam sodium 4.5 g twice daily, methylprednisolone 30 mg (the dosage was gradually decreased to 20 mg once daily) twice daily, fresh frozen plasma 400 U, oral antihistamine drugs, topical external medicine, and etc. On day 22 of the above treatments, his edemas subsided and the whole erythema disappeared. The laboratory tests showed WBC 5.6×109/L, eosinophile granulocyte 0, ALT 13 U/L, ALP 66 U/L, γ-GT 54 U/L, Scr 719 μmol/L, and PT 12.7 s.
  • Qi Xiaolian
    Adverse Drug Reactions Journal. 2018, 20(6): 450-451.
    A 35-year-old female patient with acute cerebral infarction received an IV infusion of azithromycin 0.5 g once daily for combination with pneumonia. About 10 minutes after completing the first infusion, scattered red miliary rash with itching appeared on the patient′s upper limbs, chest, and back. Drug eruption was considered, and dexamethasone 10 mg by an IV injection and loratadine tablets 10 mg by mouth once daily were given. On day 2 of admission, an IV infusion of etimicin sulfate 0.3 g, added into 0.9% sodium chloride injection 250 ml, was given once daily as anti-infective treatment. On day 7, with the disappearance of rash and itching, dexamethasone was replaced by prednisone tablets 30 mg orally once daily, and finally prednisone but not loratadine tablets were discontinued on day 14 through gradual reduction dose of 10 mg every 3 days. On day 15, the patient developed systemic diffuse erythema and facial and limb edema, and then an IV injection of dexamethasone 10 mg once daily was given again. On day 17, with the disappearance of erythema and reduction of edema, desquamation occurred on the patient′s face, body and limbs, which was diagnosed as exfoliative dermatitis, and topical 0.1% halcinonide solution mixed with Yumeijing moisturizer was given externally thrice daily. On day 19, the patient′s skin desquamation improved and edema subsided, and then the dose of dexamethasone was reduced to 5 mg once daily. On day 22, as the desquamation became slighter, dexamethasone was replaced by prednisone tablets 30 mg orally once daily, and the dose of prednisone was gradually reduced by 5 mg every 5 days. On day 26, all symptoms on the patient′s skin disappeared. The rash did not recur at 1 month of follow-up.
  • Chang Ying
    Adverse Drug Reactions Journal. 2018, 20(6): 452-453. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.014
    A 62-year-old male patient with B cell non-Hodgkin′s lymphoma received chemotherapy of rituximab combined with cyclophosphamide, epirubicin, vincristine, and prednisone. No abnormality in the chest CT examination was found before treatments. One week after finishing  the second cycle of chemotherapy, the patient developed cough, chest distress, and asthma after exercise, and etc. Lung inflammation was considered and moxalactam was given. However, the patient′s symptoms gradually worsened. One week later, he had difficulty breathing and could not stand. Then he was transferred to the 900th Hospital of the Chinese People′s Liberation Army Joint Service. The chest CT examination showed multiple patchy and network-like changes in bilateral lungs. Interstitial pneumonia was diagnosed, which was considered to be caused by rituximab combined with chemotherapy. Methylprednisolone sodium succinate and cefoperazone sodium and sulbactam sodium were given. One day later, dyspnea and chest tightness relieved obviously; 4 days later, cough and asthma improved significantly; 17 days later, the chest CT reexamination showed that the lesions in bilateral lungs improved.
  • Lin Zhiqiang, Wang Canming, Hong Shanshan, Wu Namei
    Adverse Drug Reactions Journal. 2018, 20(6): 431-435. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.007
    ObjectiveTo explore the predictive value of intradermal test on anaphylaxis induced by ceftriaxone sodium retrospectively.MethodsMedical records of patients who underwent intradermal test before ceftriaxone sodium treatment in the First Hospital of Quanzhou Affiliated to Fujian Medical University from November 2013 to June 2015 were collected with random equidistant sampling and analyzed retrospectively. The patients were divided into the positive intradermal test group and the negative intradermal test group according to the results of intradermal test. The situation of medication in patients in the positive intradermal test group and the ages, onset time of anaphylaxis, clinical manifestations, and outcomes in patients with allergic reactions after ceftriaxone sodium treatment in the negative intradermal test group were analyzed, respectively. The difference between the incidence of anaphylactic reactions after ceftriaxone sodium treatment in the negative intradermal test group and the hypothetical incidence of anaphylactic reactions after ceftriaxone sodium treatment without intradermal test were calculated according to Poisson distribution principle.ResultsA total of 943 patients were enrolled in the study, including 30 patients (3.18%) in the positive intradermal test group and 913 patients (96.82%) in the negative intradermal test group. Neither the positive and negative control tests nor the provocative tests were performed in patients in the positive intradermal test group and no allergic reactions appeared in these patients in the following treatments with cefoperazone sodium and sulbactam sodium, ceftizoxime, azithromycin, levofloxacin, amoxicillin sulbactam, teicoplanin, and moxifloxacin, respectively. Ten (1.1%) of 913 patients in the negative intradermal test group developed anaphylaxis during the use of ceftriaxone sodium, the incidence of anaphylactic reaction was 1.10%, in whom male and female were 5 respectively, aged 10 months to 52 years, 6 patients were  10 years old. Of the 10 patients with anaphylactic reactions, 4 developed within 20 minutes and 6 developed 4 to 10 days, respectively after the administration. The main symptoms were rash and pruritus, which improved after drug withdrawal and symptomatic treatments. There were no significant difference (u=0.288, P=0.77) between the incidence of anaphylactic reactions in the negative intradermal test group (1.1%) and the hypothetical incidence of ceftriaxone sodium-induced anaphylactic reactions without intradermal test (1.0%).ConclusionThe incidence of anaphylaxis did not decrease significantly in patients with negative intradermal test, suggesting that the intradermal test has no obvious value to predict the occurrence of ceftriaxone sodium-induced anaphylaxis.
  • Sun Zhihui, Zhang Hongmei, Hou Jiqiu, Li Yanhua
    Adverse Drug Reactions Journal. 2019, 21(5): 385-386. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.015
    A 59-year-old female patient received liver-protective drugs such as compound glycyrrhizin for liver cirrhosis and anti-infective agent piperacillin sodium and sulbactam sodium (2.5 g by an IV infusion, twice daily) for pneumonia, with the precondition of negative skin test. On day 4, the patient developed scattered small maculopapular rashes on her face, which then increased all over the body, located mainly in the trunk, and appeared as red round and irregular shapes, accompanied by local swelling of the mouth, and chapped lips. Considering that it was caused by piperacillin sodium and sulbactam sodium, the drug was discontinued and symptomatic and supportive treatments with methylprednisolone, desloratadine cirate disodium, and appropriate topical drugs were given immediately. Liver-protective drugs were continued and moxifloxacin was given for infection. On day 2 of drug withdrawal, the patient developed nasal and scattered skin desquamation on the nose and neck. Exfoliative dermatitis was diagnosed. On day 8 of admission, the erythema on the whole body became lighter, no new skin rashes appeared, and methylprednisolone was stopped. On day 13, the patient′s original rashes became lighter, crusted, and partially subsided.
  • Suo Lin, Wang Jia, Li Jing
    Adverse Drug Reactions Journal. 2019, 21(2): 154-155. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.020
    A 59-year-old male patient with type 2 diabetes mellitus needed to receive continuous intravenous pump infusion of amiodarone hydrochloride injection for atrial fibrillation. Considering the higher blood sugar levels of the patient, the clinician used 0.9% sodium chloride injection as the solvent and gave the infusion at the speed of 1 mg amiodarone hydrochloride injection per min via his left arm. About 1 hour later, the patient developed red and swollen on the skin around the venous access of his left arm with increased skin temperature and obvious pain. He was diagnosed as phlebitis, which was considered to be relevant with 0.9% sodium chloride injection. The solvent was changed to 5% glucose injection immediately and the infusion was given via the right arm. At the same time, the cold compress treatment was given on phlebitis area. One hour later, the skin temperature returned to normal and the symptoms of swollen and pain disappeared.
  • Zhao Rui, Ma Jingting, Wei Lina, Li Dongfu
    Adverse Drug Reactions Journal. 2019, 21(1): 59-60. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.012
    A 55-year-old female patient with cholecystitis, gallstone and secondary acute pancreatitis received an IV infusion of cefminox sodium 2.0 g twice daily. Eight days later, she developed large area of ecchymosis on her skin below the waist and abdomen, especially on that of the lower limbs. Laboratory tests showed the prothrombin time (PT) 63.0 s, prothrombin activity (PTA) 0.12, international normalized ratio (INR) 5.21, coagulation factor II activity 0.32, coagulation factor VII activity 0.02, and coagulation factor X activity 0.27. Vitamin K-dependent coagulation factor deficiency due to cefminox sodium was considered. Cefminox sodium was stopped immediately and an intramuscular injection of mephyton 10 mg once daily was given. Three days later, the laboratory tests showed PT 11.0 s, PTA 1.12, INR 0.94, coagulation factor II activity 0.83, coagulation factor VII activity 0.73, and coagulation factor X activity 0.84.
  • Adverse Drug Reactions Journal. 2019, 21(3): 161-161. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.001
  • ADR系列问答
    . 2011, 13(1): 63-1.
  • 安全信息
    . 2010, 12(4): 299-1.
  • ADE简报
    . 2001, 3(3): 201-201.
  • 不良事件
    . 2002, 4(1): 53-54.
  • 病例报道
    . 1999, 1(2): 119-120.
  • 病例报道
    . 1999, 1(2): 122-123.
  • 不良事件
    . 2002, 4(4): 272-272.
  • 病例报告
    . 2002, 4(6): 408-409.
  • Tang Hao, Qiao Yan, Yan Yan, Nie Shaoping
    Adverse Drug Reactions Journal. 2025, 27(2): 115-119. https://doi.org/10.3760/cma.j.cn114015-20240617-00456
    With the increasing prevalence of chronic kidney disease (CKD) and the progress of renal replacement therapy, there were more and more patients with long-term hemodialysis (hemodialysis). Cardiovascular diseases were the leading cause of death among hemodialysis patients, and a lot of these patients needed to be treated with percutaneous coronary intervention (PCI). However, hemodialysis patients had higher risks of both bleeding and thrombotic events, which made it difficulty to select drugs and their dosages for post-PCI dual antiplatelet therapy in clinical practice, and the impacts of hemodialysis on dual antiplatelet therapy were still unclear. We reported a 65-year-old male patient with CKD, who was on long-term hemodialysis treatment and underwent PCI for acute non-ST segment elevation myocardial infarction. The patient was given dual antiplatelet therapy with aspirin and clopidogrel after the procedure, and on the fourth day after PCI (14 hours after restarting hemodialysis), he developed subacute stent thrombosis due to clopidogrel resistance, which was resolved after revascularization. Based on the treatment experience in this patient and review of relevant literature, we proposed recommendations on management of dual antiplatelet 
  • Chen Fan, Liu Jianmin, Hu Shuli, Zhang Shaohui
    Adverse Drug Reactions Journal. 2023, 25(7): 419-423. https://doi.org/10.3760/cma.j.cn114015-20221123-01086
    Objective To explore the correlation between hypoalbuminemia and caspofungin- induced liver injury. Methods This research was designed as a retrospective cohort study. The medical records of discharged adult patients treated with caspofungin acetate for injection (caspofungin) in Wuhan No.1 Hospital from January 1, 2019 to December 31, 2021 were extracted through the electronic medical record system. According to the average serum albumin level during caspofungin treatment, patients were divided into hypoalbuminemia group and non-hypoalbuminemia group. Propensity score matching (PSM) was performed for gender, age, weight, underlying disease, and hospital stay, etc. in a 1∶1 ratio in patients between hypoalbuminemia and non-hypoalbuminemia groups. Taking the occurrence of drug-induced liver injury as the outcome index, the incidences of liver injury were compared between the 2 groups, before and after PSM. The relative risk (RR) and its 95% confidence interval (CI) of caspofungin-related liver injury were calculated by cluster study method. Results A total of 357 patients were entered, including 202 (56.6%) males and 155 (43.4%) females; 72 patients (20.2%) were in the hypoalbuminemia group and 285 patients (79.8%) were in the non-hypoalbuminemia group. Twenty-eight patients (7.8%) were judged with caspofungin-related liver injury, including 21 in the hypoalbuminemia group and 7 in the non-hypoalbuminemia group. The difference in the incidence of liver injury between the 2 groups was statistically significant whether before or after PSM [29.2% (21/72) vs. 2.5% (7/285), P<0.001; 29.2% (21/72) vs. 2.8% (2/72), P<0.001]. The results of the cluster study after PSM showed that hypoalbuminemia had a strong positive correlation with caspofungin-related liver injury (RR=10.500, 95%CI: 2.555-43.143), and the incidence of caspofungin- related liver injury in patients with hypoalbuminemia was 26.39% higher than that in patients without hypoalbuminemia. Conclusion Hypoalbuminemia was significantly correlated to the occurrence of caspofungin-related liver injury.
  • Dai Hengheng, Kong Weiwei
    Adverse Drug Reactions Journal. 2025, 27(2): 99-106. https://doi.org/10.3760/cma.j.cn114015-20240701-00503
    Objective To understand the clinical characteristics of hypophysitis due to nivolumab and provide reference for the safe use of nivolumab in clinic. Methods Relevant databases at home and abroad (up to May 31, 2024) were searched and case reports of hypophysitis caused by nivolumab were collected. Relevant information of patients (gender, age, primary disease), single and combined use of nivo- lumab, occurrence of hypophysitis, causality evaluation, intervention measures and outcomes were extracted and analyzed descriptively and statistically. Results A total of 56 case reports, 53 in English and 3 in Chinese, were enrolled in the analysis, involving 59 patients, with 40 males and 19 females. Their ages ranged from 26 to 84 years, with an average age of 61 years. The primary diseases were malignant melanoma in 20 cases, renal cell carcinoma in 19 cases, lung cancer in 11 cases, glossopharyngeal cancer in 4 cases, esophageal cancer in 2 cases, and gastric cancer, colon cancer and pleural mesothelioma in 1 case each. Among the 59 patients, 33 were treated with nivolumab monotherapy, 24 with nivolumab and ipilimumab, 1 with nivolumab and anlotinib and 1 with nivolumab and platinum. The average time of hypophysitis caused by nivolumab alone was 25.6 weeks after treatment, and that caused by the combination therapy was 9.9 weeks after treatment. The main clinical manifestations of hypophysitis caused by nivolumab were fatigue, anorexia, headache, and nausea. Among the 59 patients, 56 patients discontinued nivolumab and received glucocorticoid, 20 of whom resumed nivolumab treatment after improvement of clinical symptoms; 3 patients′ situation was not described clearly. The outcomes of the 59 patients were as follows. Four were recovered, 46 were relieved, 2 patients′ pituitary function was not recovered, 4 died, 1 developed secondary autoimmune vasculitis, 1 developed secondary autoimmune hepatitis, and it was unknown in one patient. Conclusions The average occurrence time of hypophysitis caused by nivolumab monotherapy is longer than that caused by combination therapy. The main clinical manifestations are fatigue, anorexia, headache, etc. After timely discontinuation of medication and symptomatic treatments with glucocorticoid, most patients have a good prognosis, but it can lead to death in severe cases.
  • ADE简报
    . 2000, 2(3): 199-200.
  • 安全信息
    . 2011, 13(1): 6-1.
  • ADE简报
    . 2000, 2(1): 60-60.
  • Chen Hong, Yao Gaoqiong, Qiu Feng
    Adverse Drug Reactions Journal. 2019, 21(2): 148-149. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.017
    A 77-year-old male patient received an IV infusion of tigecycline 100 mg for the acute exacerbation of chronic obstructive pulmonary disease and the flora species being sensitive to tigecycline in his antibiotic sensitivity test. About 3 hours after the infusion, the patient developed mental and behavioral abnormalities such as hallucinations and balderdash. Tigecycline was stopped the next day, and the patient′s consciousness improved and he could answer questions correctly. Because of the poor control of the infection, an IV infusion of tigecycline 50 mg was given 6 days later. About 8 hours after the infusion, the patient developed mental and behavioral abnormalities such as staring at a certain place and unresponsiveness to verbal stimuli. Then tigecycline was stopped, and the patient′s consciousness recovered.
  • Adverse Drug Reactions Journal. 2019, 21(2): 158-159. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.022
  • Shi Yang, Hou Baolin, Cao Yonghong, Fan Dengfeng, Zhang Hongxia, Chen Xiaoli
    Adverse Drug Reactions Journal. 2019, 21(6): 475-476. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.025
    Two patients (patient 1, a 54-year-old male; patient 2, a 39-year-old female) received intravenous injection of haemocoagulase agkistrodon for injection (2 U, once daily) to reduce bleeding after percutaneous holmium laser lithotripsy and hysteroscopic diagnostic curettage, respectively. Patient 1 developed urticaria on the third day of treatment. Haemocoagulase agkistrodon was stopped and cured after anti allergy treatment. Patient 2 developed palpitation, dyspnea, nausea, tremor of limbs, and etc. after about 5 minutes of medication. Her body temperature was 36.6 ℃, heart rate was 88 beats/min, breath rate was 23 times/min, blood pressure was 117/63 mmHg, and erythema appeared on her limbs and chest skin. Haemo-coagulase agkistrodon was stopped and antiallergic treatments and oxygen inhalation were given. Her symptoms disappeared about 30 minutes later and the rash disappeared 1 week later. The allergic reactions in the 2 patients were considered to be caused by haemocoagulase agkistrodon.
  • 安全信息
    . 2010, 12(6): 447-2.
  • 病例报告
    . 2001, 3(1): 46-47.
  • 不良事件
    . 2002, 4(6): 412-413.
  • 不良事件
    . 2005, 7(4): 308-309.
  • ADE简报
    . 2001, 3(4): 259-259.
  • ADE简报
    . 2001, 3(4): 261-261.
  • 不良事件
    . 2003, 5(2): 125-126.
  • ADR咨询
    . 2006, 8(6): 472-476.
  • ADE简报
    . 1999, 1(3): 192-192.
  • Lu Jianping, Liu Min, Qi Xu, Luo Can
    Adverse Drug Reactions Journal. 2018, 20(6): 444-445. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.010
    A 60-year-old male patient received continuously intravenous pump of pituitrin at a speed of 1.92 U/h for 5 days in a local hospital for intermittent hemoptysis 4 days due to fish bone stuck in throat. The amount of hemoptysis was slightly reduced, accompanied by watery stools twice during the treatment. On day 11 after hemoptysis occurrence, the patient was admitted to the Jiangsu Province Hospital due to aggravation of the disease. Repeated hemoptysis continued from the night of admission to the next morning. Then intravenously pump of pituitary at a speed of 1.92 U/h (24 U/d) was given. About 8 hours later, the patient developed abdominal pain and watery stools 5 times within 4 hours. Diarrhea caused by pituitrin was considered, excluding intestinal infection by laboratory tests. Then the pump speed was reduced to 1.73 U/h and continuously intravenous pump of phentolamine was added at a speed of 2 mg/h. Diarrhea did not recur. On day 6 of admission, the patient developed mental confusion, irrelevant answers to questions, localization disorder, dysphoria, and so on. Intracranial hemorrhage and cerebral infarction was ruled out by cranial CT examination. Electrolytes test showed blood sodium 111 mmol/L and blood potassium 2.9 mmol/L. Psychiatric symptoms secondary to electrolyte disturbances caused by pituitrin were considered. The pump speed of pituitrin was adjusted to 0.77 U/h and electrolytes supplements were given. Two days later, the patient′s mental symptoms disappeared.
  • Zhang Kuishan, Ma Li, Zhang Xin
    Adverse Drug Reactions Journal. 2018, 20(6): 458-459. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.017
    A 70-day-old female infant received propranolol hydrochloride orally for hemangioma. On day 5 after the medication, the infant developed diarrhea and hematochezia. Propranolol hydrochloride was discontinued, and montmorillonite powder 1.0 g and live combined Bifidobacterium, Lactobacillus and Streptococcus therophilus tablets 0.5 g were given thrice daily orally. Three days later, the symptoms disappeared and fecal occult blood test showed negative. One week later, propranolol hydrochloride was given again and, 2 days later, the above symptoms recurred. Propranolol hydrochloride was stopped again and above therapeutic regime as well as Ding Guier umbilical paste was given (1 paste/d). The symptoms did not improve after 7 days of the treatment. The diagnosis of allergic colitis was confirmed through colonoscopy and intestinal mucosal biopy. Montmorillonite powder 1.0 g thrice daily, live combined Bifidobacterium, Lactobacillus and Streptococcus therophilus tablets 0.5 g thrice daily, and montelukast sodium tablets 1 mg once daily were given orally, and free amino acid-based infant formula was fed. A week later, the infant′s diarrhea and hematocheiza disappeared and fecal occult blood test showed negative.
  • Fang Shengbo, Zhang Xiaoying, Li Yueyang, Zhang Wenrui
    Adverse Drug Reactions Journal. 2019, 21(4): 303-304. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.016
    A 12-year-old female pediatric patient received a continuous pumping of somatostatin 3 mg (added to 210 ml of 0.9% sodium chloride injection) by an intravenous detaining needle on the back of her left hand and an IV infusion of pantoprazole sodium for injection 25 mg (added to 100 ml of 0.9% sodium chloride injection) by an intravenous detaining needle on the back of her right hand at the same time for acute pancreatitis. About 5 minutes after the initiation of administration, cyanosis appeared on her both hands, her left hand was cold, and red rashes scattered on her left wrist and upper arm. It was considered as drug-induced anaphylaxis, and the drugs were discontinued immediately. About 40 minutes after drug withdrawal, her above symptoms relieved completely. Pantoprazole for injection was given again that day, and no allergic symptoms were observed. On day 2, a subcutaneous injection of 0.1 g octreotide acetate injection (an analogue of somatostatin) was given. About 10 minutes later, the patient developed headache, nausea, and vomiting, which relieved spontaneously after 30 minutes. It was considered that the anaphylaxis was caused by somatostatin and its analogue octreotide.
  • Chen Qiulin, Sun Zhouliang, Wang Kun, Yan Zhiwen
    Adverse Drug Reactions Journal. 2019, 21(3): 176-182. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.004
    ObjectiveTo explore the association between glutathione S-transferase (GST) M1 and T1 genetic polymorphisms and the blood methotrexate concentration at 48 hours (C48 h) after initiation of high-dose methotrexate (HDMTX) infusion and major adverse events within 72 hours in children with acute lymphoblastic leukemia (ALL).MethodsMedical records of ALL children in the First Affiliated Hospital of Xiamen University who received HDMTX-containing chemotherapy regimen, blood concentration monitoring of methotrexate at 48 hours after initiation of infusion, and GST M1 and T1 genetic polymorphism detection were collected and retrospectively analyzed.ResultsA total of 94 children with ALL were enrolled in the study, including 52 males and 42 females, aged 2-15 years with the average age of (5±3) years. Within 72 hours after the HDMTX chemotherapy, 44 children (46.8%) developed liver injury, 43 children (45.7%) developed gastrointestinal reactions, 15 children (16.0%) developed myelosuppression, and 45 children (47.9%) developed skin and mucosa injury. The children were divided into the <0.5 μmol/L group, the 0.5-1.0 μmol/L group, and the >1.0 μmol/L group according to their C48 h of methotrexate. The incidences of adverse events such as liver injury, gastrointestinal reaction, and skin and mucosa injury in the <0.5 μmol/L group were significantly lower than those in the >1.0 μmol/L group [17.9% (5/28) vs. 78.6% (11/14), 21.4% (6 /28) vs. 85.7% (12/14), 17.9% (5/28) vs. 71.4% (10/14), all P<0.001]. Significant differences of methotrexate C48 h/dose ratio were found neither between children with functional wild-type alleles of GST M1 (GST M1 non-null genotypes) and those with GST M1 null-genotypes nor between children with GST T1 non-null genotypes and those with GST T1 null genotypes (both P>0.05). But the incidences of liver injury within 72 hours after HDMTX chemotherapy in children with GST M1 and GST T1 null-genotypes were significantly higher than those in children with GST M1 and GST T1 non-null genotypes, respectively [GST M1: 50.7% (36/71) vs. 34.8% (8/23); GST T1: 55.2% (32/58) vs. 33.3% (12/36), both P<0.05]. Multivariate logistic regression analysis showed that GST M1 and GST T1 genetic polymorphisms were associated with increased risk of liver injury (OR=1.928, 95%CI: 1.353-2.745, P<0.001; OR=2.462, 95%CI: 1.046-5.793, P=0.039).ConclusionsThe C48 h of methotrexate in children with ALL and receiving HDMTX chemotherapy was associated with the occurrence of adverse events. GST M1 and GST T1 genetic polymorphisms had no significant effects on C48 h of methotrexate, but might increase the risk of liver injury in children.
  • Han Han, Wang Rong, Xie Cheng
    Adverse Drug Reactions Journal. 2019, 21(2): 156-157. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.021
    A 69-year-old female patient mistakenly took overdose of aspirin enteric-coated tablets (4.86 g, twice daily) because of memory confusion. After taking 3 times of aspirin overdose, she developed hearing loss. When the medication was taken for the seventh time (the aspirin cumulative dosage was 34.02 g), the medication error was found by her relatives. The medication was discontinued and the patient was taken to the hospital. Hearing tests suggested the sensorineural deafness and laboratory tests revealed pancytopenia. The lowest white blood cell count(WBC) was 1.9×109/L, the lowest red blood cell count(RBC) was 3.0×1012/L, the lowest hemoglobin(Hb) was 99 g/L, and the lowest platelet count(PLT) was 39×109/L. After 18 days of rehydration and symptomatic treatments, her hearing recovered to normal. Laboratory tests showed WBC 8.4×109/L, RBC 3.7×1012/L, Hb 123 g/L, and PLT 113×109/L.
  • ADE简报
    . 2001, 3(4): 258-259.
  • 不良事件
    . 2002, 4(4): 269-269.
  • 不良事件
    . 2003, 5(3): 199-199.
  • Cang Daixiao, Sun Ru'nan, Quan Xianghua, Yang Xue, Xing Xiaomin, Zhao Jun
    Adverse Drug Reactions Journal. 2025, 27(3): 147-152. https://doi.org/10.3760/cma.j.cn114015-20240528-00376
    Objective To analyze the characteristics of Fournier gangrene (FG) induced by sodium-glucose cotransporter 2 inhibitors (SGLT2i), and provide reference for clinical safe drug use. Methods CNKI, Wanfang Med Online, VIP, PubMed, Web of Science and other databases (up to January 2024) were retrieved and clinical data on patients with FG associated with the 5 kinds of SGLT2i currently used in clinical practice in China were collected and descriptively analyzed, including gender, age, comorbidities, concomitant medications, onset time and clinical manifestations of SGLT2i-related FG, laboratory and imaging examination results, treatment and outcomes, etc. Results A total of 15 documents were included in the analysis, involving 15 patients, with 12 males and 3 females. The age of these patients ranged from 34 to 72 years, with 11 cases being over 50 years. Dapagliflozin was used in 7 cases, empagliflozin in 6 cases, canagliflozin in 2 cases, and no related reports on ertugliflozin and henagliflozin were collected. The main clinical manifestations of the 15 patients were redness, swelling, pain, abscess or purulent discharge in perineum, scrotum and perianal, etc. The time from application of SGLT2i to onset of FG ranged from 1 month to 6 years. Wound secretion bacterial culture was performed in 10 patients, and the results were all positive, including 9 cases of bacterial infection and 1 case of mixed infection of bacteria and fungi. All 13 patients who underwent imaging examinations had imaging manifestations related to FG. SGLT2i were discontinued in all patients. After treatments with broad-spectrum antibiotics and surgery, 14 cases were improved and 1 case was cured. Conclusions SGLT2i has the risk of causing FG, which is more common in males. The clinical use of SGLT2i should be monitored closely. Secretion culture and imaging examination are helpful for the diagnosis of FG. The patient′s prognosis is good after discontinuation of medication, symptomatic treatment, and surgery.
  • Fang Zhenwei, Qiu Qi, Lin Yang
    Adverse Drug Reactions Journal. 2024, 26(1): 2-5. https://doi.org/10.3760/cma.j.cn114015-20231218-00906
    Along with the reforms of the assessment and approval regime for new drugs in China in recent years, independently researched and developed innovative drugs and conditionally approved drugs in China have been more and more. The pre-market clinical trials, assessment and approval system (especially the conditional approval system), and post-market monitoring and management of new drugs in China are still in a continuous improvement stage. Thus we need to specially pay attention to the safety of innovative drugs that independently developed in China and do a good job in post-marketing safety supervision. More evidence-based information for safe use of this type of medication in patients can be provided through the following aspects: strengthening the drug safety monitoring, conducting systematic evaluation of literature data, widely collecting drug safety data through high-quality real-world research, and conducting in-depth mining of information from drug safety reports.
  • Shi Qifang, Ba Gen, Li Meng, Hao Weiwen, Sun Hao, Jiang Guiping, Zhou Ying, Zhang Huazhong, Wan Jinfu, Qiao Jie, Jin Hua, Xie Min, Cao Yun, Zhou Juan, Zhao Chao, Wang Zihao, Zhang Jinsong
    Adverse Drug Reactions Journal. 2024, 26(12): 715-719. https://doi.org/10.3760/cma.j.cn114015-20240509-00323
    Objective To investigate the clinical characteristics and interventions associated with drug-induced anaphylaxis in the emergency infusion room. Methods Bases on the adverse drug reaction database from the emergency medicine center of the First Affiliated Hospital of Nanjing Medical University, clinical data of patients who experienced drug-induced anaphylaxis in the emergency infusion room between November 2019 and November 2023 were collected, including gender, age, history of previous adverse drug reactions, allergy history, Charlson comorbidity index, medication details, information related to drug-induced anaphylaxis (onset time, clinical manifestations), interventions, outcomes, and follow-up. The clinical characteristics and interventions in these patients were analyzed. Results During the study period, a total of 398 772 patients in the emergency infusion room in our hospital received intravenous infusion of drugs. Of them, 625 cases developed adverse drug reactions (ADRs) and 75 cases developed drug- induced anaphylaxis, accounting for 0.02% (75/398 772) of the total infusion patients and 12.0% (75/625) of all ADR cases. Of the 75 patients with anaphylaxis, 30 cases (40%) were classified as grade Ⅱ, and 45 cases (60%) as grade Ⅲ, with no grade Ⅳ cases. The most common drugs involved in 75 cases of anaphylaxis were anti-infective drugs (41 cases, 54.7%). Drug-induced anaphylaxis exhibited diverse clinical manifestations, with cardiovascular symptoms being the most common, primarily varying degrees of transient hypotension (67 cases, 89.3%), followed by systemic and neurological symptoms, including profuse sweating (31 cases, 41.3%) and dizziness (28 cases, 37.3%). All 75 patients with anaphylaxis were treated with measures such as discontinuation of medication, replacement of infusion sets, rapid assessment of circulation and respiration, and monitoring of vital signs, of which 65 (86.7%) received rapid intravenous infusion for volume expansion, 6 (8.0%) received intravenous injection of glucocorticoids, 3 (4.0%) received intramuscular injection of 0.5 mg epinephrine, and 2 (2.7%) received antihistamines. All 75 patients showed improvement in symptoms, and no sequelae or deaths were found. Conclusions In the emergency infusion room, the severity of anaphylaxis is mainly grade Ⅱ and Ⅲ with a good prognosis after timely intervention. The treatment measures mainly focus on rapid intravenous infusion for volume expansion, and the use of epinephrine is relatively low.
  • Zhang Yingchun, Li Mu
    Adverse Drug Reactions Journal. 2024, 26(11): 697-699. https://doi.org/10.3760/cma.j.cn114015-20230828-00639
    A 32-year-old female patient received ixekizumab injection (initially 160 mg, then 80 mg, once every 2 weeks) for palmoplantar pustulosis. After 4 times of medication, erythema and pustules of hands and feet were improved; after 6 times of medication, the patient developed erythema and papules all over the body, accompanied by obvious pruritus; after 9 times of medication, erythema nodosum and oral ulcers appeared on both lower extremities, causing eczema and Behcet′s symptoms. Laboratory tests showed hypersensitive C-reactive protein >5.0 mg/L, total IgE 2.0×106 IU/L, and erythrocyte sedimentation rate 56 mm/1 h. No abnormalities were found in other tests. Pathological examination showed that a small to medium amount of lymphocyte infiltration distributed around the full-layer vessels of the dermis; several nodules were scattered in the subcutaneous adipose tissue layer, with histocytes in the center, some of which were epithelioid, surrounded by a few lymphocytes and neutrophils, and Periodic acid-Schiff stain and acid-fast stain were negative. The patient′s symptoms were improved after discontinuing ixekizumab and receiving 2 weeks of anti-allergy, anti-inflammatory, and topical glucocorticoid therapy. At a 2-month of follow-up, Behcet′s disease symptoms and eczema-like rash did not recur.
  • Lin Qi, Dong Shujie, Li Lei, Wang Kun, Shi Junbao, Yang Li
    Adverse Drug Reactions Journal. 2025, 27(1): 53-55. https://doi.org/10.3760/cma.j.cn114015-20240304-00129
    An 82-year-old female patient with atrial fibrillation and heart failure was treated with dabigatran etexilate 110 mg twice daily for 6 years. Two months ago, the patient′s lower limb edema was aggravated and urine output was reduced. Considering the worsening of the patient′s heart failure, torasemide tablets and spironolactone tablets were given, but her symptoms were not improved. Two days ago, the patient had scattered petechiae on the whole skin, tarry stools, and reduced urine (200 ml daily). Laboratory tests showed hemoglobin (Hb) 63 g/l, prothrombin time (PT) 39.5 s, activated partial thromboplastin time (APTT) 117.2 s, thrombin time (TT) >300 s, and international normalized ratio (INR) 3.64; the fibrinogen (Fib) could not be measured. Coagulation dysfunction and gastrointestinal bleeding caused by dabigatran etexilate were considered. Dabigatran etexilate was discontinued, and intravenous infusion of idarucizumab injection (2.5 g) was given twice. Then gastrointestinal bleeding in the patient disappeared and laboratory tests showed PT 12.7 s, APTT 42.4 s, TT 18.8 s, INR 1.18, and Fib 2.67 g/L. After 8 days, the patient′s cardiac function was improved, the skin ecchymosis subsided, and laboratory tests showed Hb 84 g/L, PT 14 s, APTT 37.8 s, TT 41.2 s, INR 1.3, Fib 2.26 g/L, and negative fecal occult blood test.
  • 不良事件
    . 2005, 7(4): 310-311.
  • 不良事件
    . 2003, 5(4): 273-273.
  • 系列问答
    . 2009, 11(4): 300-1.
  • Liu Li1, Gong Qian2
    Adverse Drug Reactions Journal. 2019, 21(1): 64-66. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.015
    A 68-year-old male patient with lung adenocarcinoma and bone and adrenal metastasis received an IV infusion of nivolumab 180 mg (on day 1 of each chemotherapy cycle of 14 days), and completed 3 cycles in total. On day 70 after the first infusion, the patient developed fever, cough with sputum, and dyspnea. The above symptoms aggravated gradually despite oxygen and anti-infective treatment for 3 days. Blood gas analysis indicated type I respiratory failure. Ground glass opacities and reticular opacities in bilateral lungs were found in the chest CT. Considering the immune-related pneumonia complicated by infection induced by nivolumab, high-dose methylprednisolone was given to inhibit the immune response, meropenem and voriconazole were given to prevent infection, and oxygen and expectorants were given as the symptomatic and supportive treatments. Finally the symptoms of the patient gradually relieved.
  • Yao Fei
    Adverse Drug Reactions Journal. 2019, 21(4): 313-314. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.021
    A 72-year-old male patient received endocrine therapy with oral bicalutamide (50 mg, once daily) and subcutaneous injection of leuprorelin acetate microspheres sustained release for injection (3.75 mg, once per 4 weeks) as well as treatment for bone pain with IV infusion of zoledronic acid injection (4 mg once per 4 weeks, added into 100 ml of 0.9% sodium chloride injection) for prostate cancer with multiple bone metastases. After more than 9 months of treatments, the patient developed dyspnea and then fever. He was diagnosed as having pneumonia through CT examination of the lungs. The patient′s symptoms did not improve after anti-infective treatments. The respiratory physician considered the patient to have interstitial pneumonia caused by bicalutamide. The drug was discontinued, and methylprednisolone (the initial dose was 240 mg, which was gradually reduced after the symptoms improved) was given. The patient′s symptoms improved, and the chest X-ray examination showed that the lung inflammation was reduced.
  • 安全信息
    . 2011, 13(2): 133-1.
  • ADE简报
    . 2000, 2(1): 59-59.
  • 不良事件
    . 2002, 4(4): 271-272.
  • 不良事件
    . 2002, 4(6): 414-414.
  • Adverse Drug Reactions Journal. 2023, 25(12): 723-723. https://doi.org/10.3389/fphar.2023.1241524
    美国FDA不良事件报告系统(FAERS)收集的是医务人员、消费者和制造商的自发报告。观察到、听到或认定自己经历过药物不良反应的个人都可能会报告,同一事件可能会有多个来源的报告。因此,重复报告是FAERS数据发掘的重大局限性,彻底删除重复报告是所有分析(尤其是报告比数不相称分析)的先决条件。
    Schilder等对Tian等2022年发表的1篇文章作了调查(Tian X, et-al. Adverse event profiles of PARP inhibitors: analysis of spontaneous reports submitted to FAERS[J]. Front Pharmacol, 2022, 13: 851246. DOI: 10.3389/fphar.2022.851246)。Tian等利用美国FAERS数据库2014年12月至2021年10月的数据集对4种多聚ADP核糖聚合酶(PARP)抑制剂(尼拉帕尼、奥拉帕尼、鲁卡帕尼和他拉唑帕尼)的安全性进行了不相称性分析。他们根据识别号删除重复报告,确定了24-141份涉及PARP抑制剂的报告,并根据国际医学用语词典(MedDRA)首选术语计算了多个不良事件的报告比值比(ROR);发现了16例与尼拉帕尼相关的淋巴血管平滑肌增生症(LAM)的报告,ROR为471.20。
    Schilder等检索FAERS后发现,尼拉帕尼关联LAM的报告是14份。2022年4月1日在Commonwealth警戒工作台系统自动删除FAERS数据集的重复数据(CVW数据发掘构建6.0.2.60)之后,仅剩6份尼拉帕尼关联LAM的报告。之后,作者获得了这6份报告的病例信息,发现:“所有6份报告的事件发生日期、年龄、体重、国家、尼拉帕尼使用开始/结束日期、尼拉帕尼批号、可疑药物和伴随药物的可用数据都是相同的”,“强烈表明这6份报告都是单一病例的重复。”作者还在GSK全球安全数据库中检索了截至2022年7月22日的报告,找到了1份尼拉帕尼关联LAM的报告,与现有FAERS中病例报告的详细信息完全匹配。作者调查的结论是,Tian等的研究由于未能删除重复数据,导致了错误的结果。
    Schilder等认为,考虑到FAERS数据库和方法学方面的局限性,严格地去除重复报告和谨慎解释研究结果至关重要。
  • Adverse Drug Reactions Journal. 2024, 26(1): 1-1. https://doi.org/10.3760/cma.j.cn114015-20231218-00905
  • Huang Minjun, Bao Kun, Ma Weizhong, Yang Haifeng
    Adverse Drug Reactions Journal. 2023, 25(11): 697-699. https://doi.org/10.3760/cma.j.cn114015-20230228-00128
    A 65-year-old male patient with stage Ⅳa lung adenocarcinoma had microscopic hema- turia for more than 10 years, and his urinary occult blood fluctuated between (+) and (++). Because his tumor target gene test showed that the epidermal growth factor receptor L858R mutation was positive, he received gefitinib 250-mg once daily orally. Laboratory tests before treatments showed albumin (ALB) 37.2-g/L, serum creatinine (Scr) 73-μmol/L, and urine occult blood (++). After 2 days of treatment, the patient developed generalized rashes, obvious foam urine, and severe edema of both lower limbs. Two weeks later, laboratory tests showed urinary occult blood (++++), urinary protein (++++), ALB 28.3-g/L, and Scr 111-μmol/L. The Scr peak value was 135-μmol/L and ALB trough value was 21.5-g/L. The drug eruptions and nephrotic syndrome caused by gefitinib were considered, gefitinib was discontinued, and symptomatic and supportive treatments were given. After 3 days, the rashes and edema gradually subsided, and the anti-tumor drug was switched to osimertinib. The pathological examination of renal puncture showed IgA nephropathy. Gefitinib-induced nephrotic syndrome on the basis of primary IgA nephropathy was considered. After 17 days, the patient′s rashes completely subsided and the edema was significantly improved. At 8 months of follow-up, the laboratory tests showed ALB 37.9-g/L, Scr 130-μmol/L, and urinary protein (++), suggesting that the renal injury had not yet fully recovered.
  • Chen Sheng, Wan Chang, Zhang Yiruo
    Adverse Drug Reactions Journal. 2024, 26(2): 106-110. https://doi.org/10.3760/cma.j.cn114015-20230328-00223
    The third generation of epidermal growth factor receptor (EGFR) tyrosine kinase inhibi- tors (TKIs), such as osimertinib, almonertinib, and furmonertinib, played a crucial role in the treatment of advanced non-small cell lung cancer with EGFR gene mutations. However, it was essential to consider their potential cardiotoxicity. Currently, the primary cardiotoxicity associated with this kind of drugs was prolongation of the corrected QT interval, followed by decline in left ventricular ejection fraction and heart failure. These manifestations could occur independently or concurrently. The underlying mechanism responsible for the cardiotoxicity of the third generation EGFR-TKIs remained unknown but might be attributed to inhibition of the human epidermal growth factor receptor 2 (HER-2) signal pathway, suppression of the phosphoinositide 3-kinase (PI3K)/Akt pathway, blockade of the human ether-à-go-go-related gene (hERG) potassium channel, inhibition of the voltage-gated sodium channel (Nav1.5), and modulation of the L-type calcium channel. Therefore, caution should be exercised when using the third generation EGFR-TKIs clinically by promptly identifying high-risk individuals susceptible to cardiotoxicity and closely conducting therapeutic drug monitoring.
  • 不良事件
    . 2004, 6(2): 130-130.
  • 安全信息
    . 2012, 14(5): 333-2.
  • Adverse Drug Reactions Journal. 2019, 21(6): 485-485. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.030
  • Wang Xiaoyan, Ni Liming, Lei Ximei
    Adverse Drug Reactions Journal. 2019, 21(6): 443-444. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.009
    A 3-day-old newborn boy received Yinzhihuang oral solution 3 ml thrice daily because of jaundice. One day after the medication, the baby′s jaundice aggravated obviously, the laboratory tests showed total bilirubin (TBil) 385 μmol/L and hemoglobin (Hb) 163 g/L, and he had dark brown urine. Treatment with blue light phototherapy was added. Laboratory tests showed TBil 431 μmol/L and Hb 99 g/L on day 8 after birth. The baby′s TBil level was decreased provisionally after the peripheral arteriovenous exchange transfusion, but increased again several hours later. It was considered that the repeated increase of TBil might be related to Yinzhihuang oral solution. Yinzhihuang oral solution was stopped. On day 2 after drug withdrawal, the baby′s TBil decreased to 146 μmol/L and the urine turned clear. The baby was diagnosed as glucose-6-phosphate dehydrogenase (G-6-PD) deficiency by gene diagnosis after discharge. It was considered that hemolytic jaundice in the neonate with G-6-PD deficiency may be induced by Yinzhihuang oral solution.
  • Wei Lina, Li Ping, Yang Xue, Fu Lei, Cheng Cheng, Sun Wei
    Adverse Drug Reactions Journal. 2018, 20(6): 472-474. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.024
    A 60-year-old male patient with chronic renal failure accompanied by renal hypertension received long-term treatment with amlodipine 10 mg (orally, once daily), captopril 37.5 mg ( orally, thrice daily), and regular hemodialysis (thrice weekly), and his blood pressure was maintained in the range of 150-160/60-70 mmHg. The patient went to the drugstore to buy medicine and the pharmacy clerk sold carbamazepine to him in mistaken for captopril. The patient had taken carbamazepine for 3 days when he found the medication error. Carbamazepine was discontinued by the patient and only amlodipine was taken regularly. Twelve days after captopril withdrawal, the patient developed dizziness, headache, nausea, and vomiting, and his blood pressure was 200/70 mmHg. Three days later, the patient was diagnosed as malignant hypertension and admitted to hospital because his blood pressure increased to 250/100 mmHg. After admission, the patient was given an infusion pump of sodium nitroprusside (1 mg/ml, pump rate 6-8 ml/h) and oral medicines of valsartan and amlodipine tablets (1 tablet, twice daily), terazosin hydrochloride tablets (4 mg, twice daily), and metoprolol succinate sustained-release tablets  (47.5 mg, once daily), and hemodialysis was continued (thrice weekly). On the Sixth day of admission, the infusion pump of sodium nitroprusside was changed to nicardipine (0.6 mg/ml, pump rate 6-11 ml/h). On day 10, the patient′s blood pressure dropped to 150/82 mmHg and oral spironolactone 20 mg thrice daily was added. On day 20, his blood pressure dropped to 124/83 mmHg and then the patient was discharged. At 2 months of follow-up, the patient did not have hypertension again.
  • Zhu Minghui, Gao Yiling, Chen Jun, Yao Feifei
    Adverse Drug Reactions Journal. 2018, 20(6): 465-466. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.020
    A 71-year-old male patient with acute brain stem infarction received an IV infusion of ceftriaxone sodium for injection 3 g, dissolved in 0.9% sodium chloride injection 100 ml, for later pulmonary infection. About 3 hours after completing the infusion, the patient developed red swelling on the hands and feet, and skin redness and rash on multiple parts of the body. About 6 hours after completing the infusion, he developed multiple vesiculobullous on the hands, thighs root and perineum. Bullous epidermal necrolysis drug eruption induced by ceftriaxone sodium for injection was considered. The anti-infective drug was changed to be moxifloxacin and drugs for brain infarction were continued. At the meantime, the patient was given symptomatic supportive treatments such as anti-allergy, topical medication in skin lesions, and visible light treatment at skin ulceration. Five days later, the whole rash subsided.
  • Yu Zhipeng, Qian Yulan
    Adverse Drug Reactions Journal. 2019, 21(5): 395-396. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.020
    A 76-year-old female patient received one perindopril and indapamide tablet (containing perindopril 4.00 mg and indapamide 1.25 mg in each tablet) once daily for hypertension. Her blood pressure was well controlled. One month later, the patient was admitted to hospital for hyperglycemia. On day 2 of admission, the patient developed fever, with the highest body temperature of 38.4 ℃. Laboratory tests showed that her white blood cell count(WBC) was 1.7×109/L and neutrophils count was 0.38×109/L, which was considered to be related to perindopril and indapamide. Then perindopril and indapamide was discontinued and replaced by amlodipine besylate. And recombinant human granulocyte colony stimulating factor, leucogen, vitamin B4, and anti-infective drugs were also given. On the second day of treatment, the WBC was 6.0×109/L and neutrophils count was 4.05×109/L. The patient′s body temperature returned to normal on day 6 of admission and her WBC, neutrophils count, blood glucose, and blood pressure were 6.2×109/L, 4.55×109/L, 6.7 mmol/L, and 128/79 mmHg, respectively on day 8.
  • Zhang Hongmei, Hou Jiqiu, Sun Lirui, Zhou Wei
    Adverse Drug Reactions Journal. 2019, 21(5): 397-398. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.021
    A 30-year-old male patient received pancreatin enteric-coated capsules 0.45 g thrice daily with meals for chronic pancreatitis. On day 9 of medication, the patient developed discomfort in the right first metatarsophalangeal joint. The next day, his symptoms were aggravated, manifested by metatarsophalangeal joint pain and swelling. Laboratory tests showed an increase of uric acid (477 μmol/L), which was considered to be gouty arthritis induced by pancreatin enteric-coated capsules. Then the drug was discontinued and symptomatic treatments such as alkaline urine and analgesics were given. On day 5 of drug withdrawal, the swelling of the right metatarsophalangeal joint was markedly alleviated and the tenderness was significantly relieved. On day 8 of drug withdrawal, swelling and pain in the patient′s right metatarsophalangeal joint disappeared and his uric acid level was 430 μmol/L. The patient was discharged. At 2 weeks of follow-up, his uric acid returned to normal.
  • WHO信息
    . 2002, 4(2): 137-137.
  • Pei Yihan, Li Yue, Bi Yunyan, Guo Nan, Zhang Wen
    Adverse Drug Reactions Journal. 2024, 26(3): 178-183. https://doi.org/10.3760/cma.j.cn114015-20231129-00845
    Targeted therapy is one of the important methods of treatment for non-small cell lung cancer (NSCLC). Tyrosine kinase inhibitors (TKIs) have the characteristics of high efficacy and low toxicity, and are used in the precise treatment in NSCLC patients with gene mutation. Common gene mutations include genes encoding epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK). Different patients have different responses to TKIs. Monitoring the blood concentration of TKIs can help better predict the clinical outcome (efficacy/toxicity) and optimize the treat strategies. In this paper, the relevant literature at home and abroad in the past 10 years are searched, and the relationship between the blood trough concentration of EGFR-TKI and ALK-TKI commonly used in clinic and the efficacy/toxicity are reviewed.
  • Ye Ruohan, Wu Yaozhou, Wei Li, Yu Pengjiu
    Adverse Drug Reactions Journal. 2023, 25(7): 413-418. https://doi.org/10.3760/cma.j.cn114015-20220503-00379
    Objective To explore the clinical characteristics of lung injury related to tyrosine kinase inhibitors (TKIs). Methods The electronic medical records of patients with lung injury who received TKIs treatment in the First Affiliated Hospital of Guangzhou Medical University from August 2014 to May 2019 were collected by searching the Hospital Information System and retrospectively analyzed. The data extracted from the medical records included the patient′s gender, age, primary disease, clinical manifestation, TKIs medication, time from TKIs medication to occurrence of lung injury, laboratory test and imaging examination results, treatment and outcome, etc. Results A total of 20 patients were enrolled in the study, including 10 males and 10 females. Their ages were from 32 to 75 years, with a median age of 60 years. The primary diseases were lung adenocarcinoma in 16 cases, chronic myeloid leukemia in 3 cases, and small intestinal stromal cell tumor in 1 case; 6 patients had smoking history; the clinical manifestations were cough in 19 patients, shortness of breath after activity in 17 patients, expectoration in 12 patients, chest pain and fever in 5 patients each, fatigue in 1 patient, and hypoxemia in 13 patients. Among the 20 patients, 17 were treated with epidermal growth factor receptor TKI and 3 with imatinib. The time of occurrence of lung injury was 2 days to 2 years after medication, with a median time of 1 month. Laboratory tests showed that the level of C-reactive protein increased in 15 patients, the level of Krebs von den Lungren-6 increased in 11 patients, procalcitonin increased in 11 patients, erythrocyte sedimentation rate increased in 10 patients, and lactate dehydrogenase increased in 6 patients; partial pressure of oxygen decreased in 13 patients, oxygen saturation decreased in 11 patients, partial pressure of carbon dioxide decreased in 7 patients, and partial pressure of carbon dioxide increased in 5 patients. All 20 patients underwent chest CT examination, showing patchy ground glass shadow in 18 patients, pleural effusion in 8 patients, nodules in 6 patients, interlobular septal thickening in 3 patients, grid fuzzy shadow in 2 patients, and pneumothorax in 1 patient. After the occurrence of lung injury, all patients stopped TKIs, 18 received glucocorticoid and symptomatic treatments, 4 were cured, 9 were improved, 4 had poor efficacy, and 1 died; 2 patients were improved only after anti- infection and symptomatic treatments. Conclusions The clinical manifestations of lung injury related to TKIs are nonspecific, and the time from medication to occurrence of adverse reactions varies. After drug withdrawal and receiving glucocorticoid and symptomatic treatments, the prognosis in most patients is good. However, the occurrence of adverse consequences should be paid attention to.
  • Zhang Yan, Cai Yichao, Cao Na, Yang Huiru, Bian Xinghua, Li Kan
    Adverse Drug Reactions Journal. 2024, 26(11): 672-676. https://doi.org/10.3760/cma.j.cn114015-20240322-00188
    Objective To explore the impact on analgesic efficacy and safety of esketamine as an adductor canal block adjuvant in knee arthroplasty. Methods The study was a prospective, single center, randomized controlled trial. The subjects were patients who received knee arthroplasty in Zhangjiakou First hospital from October 2021 to October 2023. The patients were randomly divided into trial group and control group using a random number table method. The patients in the both groups received general anesthesia and postoperative patient-controlled intravenous analgesia (PCIA). The patients in the trial group were injected with 0.375% ropivacaine combined with esmketamine, while those in the control group were only injected with 0.375% ropivacaine. The postoperative vital signs, quadriceps femoris muscle strength, resting and dynamic visual analogue scale (VAS) pain score, use of PCIA, and incidence of postoperative adverse reactions in patients between the 2 groups were compared. Results A total of 120 patients were included in this study, with 60 cases in each group. There were no significant differences in heart rate, mean arterial pressure, respiratory rate, and body temperature in patients between the trial group and the control group at 24 and 48 hours after operation (all P>0.05). There were no significant differences in quadriceps femoris muscle strength at 12, 24 and 48 hours after operation (all P>0.05). At rest, the VAS pain score at 12?hours after operation in the trial group was lower than that in the control group [(2.89±0.49) points vs. (3.36±0.23) points], the difference was statistically significant (P<0.05). In the active state, the VAS scores at 12 and 24 hours after operation in the trial group were lower than those in the control group [(3.78±0.41) points vs. (4.11±0.45) points, (3.79±0.56) points vs. (4.19±0.69) points], the differences were statistically significant (all P<0.05). The number of times of PCIA compression 24 hours after operation in the experimental group was less than that in the control group [(5.35±1.03) times vs. (7.89±1.34) times], and the difference was statistically significant (P<0.05), the sensory block time in the experimental group was longer than that in the control group [(488.26±57.75) min vs. (92.26±65.15) min], and the difference was statistically significant (P<0.05). There were no significant differences in total incidence of adverse reactions including nausea, vomiting, urinary retention, dizziness, drowsiness, delirium and hallucination in patients between the 2 groups within 1 week after operation (all P>0.05). Conclusion Esketamine as an adjuvant of ropivacaine for adductor block can alleviate the pain level of patients undergoing knee arthroplasty, and it has good safety.
  • 不良事件
    . 2003, 5(3): 200-200.
  • ADE简报
    . 2000, 2(4): 264-264.
  • 不良事件
    . 2003, 5(4): 268-268.
  • He Zhongfang, Yang Qingqing, Lu Yaqin, Jiang Zhenxiu, Liu Zhaodong, Liang Li
    Adverse Drug Reactions Journal. 2019, 21(5): 391-392. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.018
    A 63-year-old female patient received IV infusions of salvianolate, cattle encephalon glycoside, and pantoprazole and an intramuscular injection of diphenhydramine (only once) in Emergency Department for dizziness, nausea, vomiting, and weakness of lower limbs. Laboratory tests showed no abnormalities in liver function. Craniocerebral CT showed multiple lacunar ischemic demyelination and bilateral internal carotid atherosclerosis. The patient was diagnosed with lacunar cerebral infarction and admitted to hospital. On the night of admission, oral rosuvastatin calcium 10 mg/d and clopidogrel 75 mg/d were given. Eleven hours later, laboratory tests showed aspartate aminotransferase (AST) 254 U/L and alanine aminotransferase (ALT) 157 U/L. Salvianolate and pantoprazole were discontinued and reduced glutathione was given. On day 3 of reduced glutathione treatment, laboratory tests showed AST 587 U/L and ALT 660 U/L. Rosuvastatin calcium-induced liver transaminase elevation was considered. Then rosuvastatin calcium was discontinued and compound glycyrrhizin was given. On day 9 of rosuvastatin calcium withdrawal, laboratory tests showed AST 112 U/L and ALT 201 U/L, and then reduced glutathione was discontinued. On day 15 of rosuvastatin calcium withdrawal, laboratory tests showed AST 42 U/L and ALT 63 U/L, and then compound glycyrrhizin was discontinued. The patient was discharged 4 days later. At 2 weeks of follow-up, no abnormalities in liver function were found in the patient.
  • Wang Jing, Chen Can, Wang Xiaocheng, Zhou Min, He Juanhua, Liao Hui, Li Yuanping
    Adverse Drug Reactions Journal. 2019, 21(5): 346-352. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.007
    ObjectiveTo evaluate the relationship between proton pump inhibitor (PPI) and the risk of spontaneous bacterial peritonitis (SBP) in cirrhosis patients systematically.MethodsThe literature on the related databases as of February 2019 was searched. Case-control studies, cohort studies, and randomized controlled studies (RCT), which set the theme as the relationship between PPI and SBP in cirrhosis patients, whose main outcome indicator was SBP incidence, and which had high quality assessed by Newcastle-Ottawa Scale or modified Jadad scoring method, were collected. The meta-analysis was performed using Rev Man 5.3 software.ResultsA total of 18 studies were enrolled in the meta-analysis. Of the 18 studies, 8 were case-control studies, 9 were cohort studies, and 1 was RCT; 6 were prospective studies and 12 were retrospective studies; 13 were single-center studies and 5 were multi-center studies. A total of 6 961 patients were included, 3 353 in the trial group and 3 608 in the control group. The patients in the trial group received PPI alone and the patients in the control group did not receive any acid-suppressing drug. Overall analysis of the 18 studies showed that the risk of SBP in patients in the trial group was markedly higher than that in the control group (OR=1.83, 95%CI: 1.43-2.33, P<0.001). The results of subgroup analysis for 8 case-control studies showed that the risk of SBP in patients in the trial group was markedly higher than that in the control group(OR=2.38, 95%CI: 1.69-3.36, P<0.001). The results of subgroup analysis for 9 cohort studies showed that the risk of SBP of patients in the trial group was markedly higher than that in the control group (OR=1.27, 95%CI: 1.04-1.55, P=0.020). The results of subgroup analysis for 12 retrospective studies showed that the risk of SBP in patients in the trial group was markedly higher than that in the control group (OR=1.81, 95%CI: 1.34-2.45, P=0.001). The results of subgroup analysis for 6 perspective studies showed that the risk of SBP in patients in the trial group was markedly higher than that in the control group (OR=1.88, 95%CI: 1.27-2.79, P=0.002). The results of subgroup analysis for 13 single-center studies showed that the risk of SBP in patients in the trial group was markedly higher than that in the control group (OR=1.97, 95%CI: 1.41-2.76, P<0.001). The results of subgroup analysis for 5 multicenter studies showed that the risk of SBP in patients in the trial group was markedly higher than that in the control group (OR=1.69, 95%CI: 1.33-2.13, P<0.001). ConclusionsPPI can increase the risk of SBP in patients with liver cirrhosis. It is suggested that PPI be used cautiously in patients with liver cirrhosis.
  • Zhou Xuehui1, Chen Yan2, Yang Yongtao2
    Adverse Drug Reactions Journal. 2019, 21(1): 69-70. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.017
    A 51-year-old female patient with breast cancer received apatinib 0.5 g/d orally on day 1 to 8 and vinorelbine 40 mg/d orally on day 1 to 3 for liver, bone, and lymph node metastasis. The treatment course was 21 days. Before medication, the patient′s liver and kidney functions were normal. On day 6 of the first course, the patient presented with abdominal pain accompanied by black stool. No improvement was observed after acid suppression and mucosal protection treatments. On day 9, laboratory tests showed alanine aminotransferase (ALT) 87 U/L, aspartate aminotransferase (AST) 529 U/L, gamma glutamyl transpeptidase (γ-GT) 520 U/L, total bilirubin (TBil) 43.70 μmol/L, direct bilirubin(DBil) 15.50 μmol/L; CT examination showed multiple low-density nodules in the liver, widening of intrahepatic bile duct, thickening of gallbladder wall, and a small amount of hydrothorax and peritoneal effusion.Acute liver failure was diagnosed. Omeprazole, somatostatin, polyene phosphatidylcholine, reduced glutathione, complex coenzyme, thrombin, and sodium carosulfonate were given. On day 11, the patient developed dysphoria, shortness of breath, anuria and other symptoms. The laboratory tests showed ALT 1 447 U/L, AST 6 060 U/L, γ-GT 386 U/L, TBil 135.60 μmol/L, DBil 93.20 μmol/L. His family members gave up treatments. There was a clear time correlation between the acute liver failure and the application of apatinib and vinorelbine in the patient. So the acute liver failure was considered to be caused by the combination use of the two drugs.
  • Li Zhengrong, Wang Juan, Wu Fangfang, Che Fengyuan, Li Hongyan, Shi Zengcheng, Ou Zhihong
    Adverse Drug Reactions Journal. 2019, 21(4): 252-257. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.003
    ObjectiveTo explore the predictive value of INR in early stage  of warfarin therapy (early INR) for anticoagulation intensity after 7 days of treatment.MethodsThe medical records of patients hospitalized in the Department of Cardiology, Linyi People′s Hospital, Shandong University from January 2012 to May 2015 were collected, who received warfarin anticoagulation therapy and underwent INR tests in the morning after 3 or 7 days of medication. The early INR meant INR after 3 days of warfarin treatment. According to INR after 7 days of warfarin treatment, the patients were divided into 2 groups, anticoagulation up to standard (INR 2.0-3.0) group and over-anticoagulation (INR>3.0) group. The best critical value of early INR for predicting INR after 7 days of warfarin treatment was obtained by plotting ROC curve. The risk of over-anticoagulation after 7 days of warfarin treatment was compared in patients with early INR ≥ critical value and<critical value. Univariate analysis was used to compare the clinical characteristics in the 2 groups. The indexes with P<0.100 were used as covariate and multivariate logistic regression analysis was performed. The odds ratio (OR) and its 95% confidence interval (CI) was calculated and independent risk factors of INR>3.0 after warfarin treatment were screened.ResultsA total of 75 patients with atrial fibrillation were enrolled in the study, including 38 males and 37 females, aged (64±9), 42 patients in the anticoagulation up to standard group and 33 patients in the over-anticoagulation group. There were significant differences in body weight, INR after 3 days of medication, and the number of patients with hypoproteinemia between the 2 groups (all P<0.05), but no significant differences in other indicators (all P>0.05). The results of ROC curve showed that the best critical value of anticoagulation intensity predicted by early INR was 1.67, the area under the curve was 0.915[95%CI: 0.828-0.967], and the sensitivity and specificity were 0.95 and 0.82, respectively. The risk of over-anticoagulation in patients with 7 days of warfarin treatment in the group with early INR ≥1.67 was significantly higher than that in the group with early INR <1.67 [90.0%(27/30) vs. 13.3%(6/45), χ2=39.883, OR=58.50, 95%CI: 13.45-254.48, P<0.001]. Multivariate logistic regression analysis showed that early INR≥1.67 was an independent risk factor for over-anticoagulation after 7 days of treatment (OR=48.719, 95%CI: 10.891-217.940, P<0.001).ConclusionsThe early INR can predict anticoagulation intensity after 7 days of treatment. Early INR ≥1.67 is an independent risk factor for over-anticoagulation after 7 days of warfarin treatment.
  • Yuan Fengbo, Kang Man
    Adverse Drug Reactions Journal. 2018, 20(6): 467-468. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.021
    A 70-year-old male patient received pantoprazole because of stomachache with bloody stools for 1 day and positive fecal occult blood test. The laboratory tests before medication showed total bilirubin(TBil) 11.3 μmol/L, direct bilirubin(DBil) 4.0 μmol/L, alkaline phosphatase(ALP) 72 U/L, alanine aminotransferase(ALT) 59 U/L, aspartate aminotransferase(AST) 55 U/L, and glutamyltransferase(γ-GT ) 65 U/L. On day 4 after medication, the patient was diagnosed as ulcerative colitis. Pantoprazole was stopped and cimetidine, mesalazin enteric-coated tablets, compound glutamine entersoluble capsules, and live combined bifidobacterium and lactobacillus tablets were given. After 3 days of treatments, formed stools appeared and abdominal pain and bloody stools disappeared. On day 6, cimetidine was stopped. On day 11, the laboratory tests showed TBil 37.8 μmol/L, DBil 20.8 μmol/L, ALT 660 U/L, AST 236 U/L, γ-GT 424 U/L, and ALP 217 U/L. Drug-induced liver injury was diagnosed. Then mesalazin was withdrawn, other drugs continued, and liver protection treatment was given at the same time. After 10 days of treatment, the laboratory tests showed TBil 21.3 μmol/L, DBil 9.4 μmol/L, ALT 97 U/L, AST 27 U/L, γ-GT 247 U/L, and ALP 122 U/L. At one and a half months of follow-up, no abnormality occurred.
  • Adverse Drug Reactions Journal. 2019, 21(2): 128. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.010
  • Zhang Lixin, Niu Kai
    Adverse Drug Reactions Journal. 2019, 21(1): 61-62. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.013
    An 80-year-old male patient with lumbar vertebral tuberculosis took tiopronin (0.2 g, thrice daily) to protect liver during chemotherapy for tuberculosis. After 7 months of treatment, eyelids and lower limbs edema appeared, then abdominal distension and urine volume decrease appeared gradually (urine volume was about 800 ml within 24 hours). Laboratory test showed that the serum total protein was 49 g/L, albumin was 18 g/L, urine protein was positive (+++), 24-hour urine protein quantitation was 3 720 mg(24-hour urine volume was 750 ml ). Tiopronin was stopped, antituberculotic therapy was continued, and symptomatic supportive treatments including antihypertensive, anticoagulant, diuretic, and kidney-protective therapy were given. Two weeks later, the patient′s edema disappeared, serum albumin increased to 25 g/L, and 24-hour urine protein quantitation decreased to 1 296 mg (24 hours urine volume was 1 500 ml). Four weeks later, urine protein test turned negative. At 6 months of follow-up, above mentioned symptoms did not recur.
  • Wang Rui, Zhang Wenrui, Wang Xiangfeng, Zhang Yongkai
    Adverse Drug Reactions Journal. 2019, 21(5): 393-394. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.019
    An 8-month-old female infant received propranolol 2 mg orally twice daily and prednisone 7.5 mg orally once daily for kaposiform hemangioendothelioma. Due to poor efficacy, propranolol and prednisone were discontinued and sirolimus 0.2 mg was given orally twice daily. The child′s liver function was normal before sirolimus treatment. On day 10 of sirolimus treatment, the laboratory tests showed alanine aminotransferase(ALT) 58 U/L, aspartate aminotransferase(AST) 116 U/L, γ- glutamyltransfarase(γ-GT) 84 U/L, alkaline phosphatase(ALP) 181 U/L, total bile acid(TBA) 109.2 μmol/L, total bilirubin(TBil) 57.4 μmol/L, and direct bilirubin(DBil) 38.0 μmol/L. At the same time, the child developed decrease of appetite, milk refusal, and cry and scream all the time. The physical examination showed slightly yellow on her skin and sclera. Cholestatic liver injury caused by sirolimus was considered. Sirolimus was discontinued and liver-protective therapy and drugs for anti-jaundice were given. On day 6 of drug withdrawal, the laboratory tests showed ALT 58 U/L, AST 116 U/L, γ-GT 84 U/L, ALP 181 U/L, TBA 109.2 μmol/L, TBil 41.5 μmol/L, and DBil 20.8 μmol/L; the child′s appetite recovered, yellowish skin and sclera improved markedly. On day 20 of drug withdrawal, the child was discharged. No abnormalities were found in the child′s liver function after 15 days of discharge.
  • ADR咨询
    . 2003, 5(5): 355-355.
  • 不良事件
    . 2003, 5(2): 126-127.
  • WHO信息
    . 2002, 4(5): 352-352.
  • 不良事件
    . 2004, 6(1): 59-59.
  • Zhao Yan, Zhu Liyao, Zhou Jian
    Adverse Drug Reactions Journal. 2019, 21(6): 457-458. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.016
    A 30-year-old male patient received oral oxcarbazepine (300 mg in the morning and 600 mg at night) for epilepsy recurrence after drug withdrawal. The patient′s liver function was normal before taking oxcarbazepine [alanine aminotransferase (ALT) 24 U/L, aspartate aminotransferase (AST) 22 U/L, alkaline phosphatase (ALP) 61 U/L, gamma-glutamyltransferase (γ-GT) 55 U/L, total bilirubin (TBil) 8.7 μmol/L, and direct bilirubin (DBil) 5.2 μmol/L]. After 12 days of treatment, the patient developed mild liver injury (ALT 70 U/L). Tiopronin was given and oxcarbazepine was continued. However, the liver injury gradually worsened and the patient developed anorexia and yellow urine after 23 days of oxcarbazepine treatment. On day 30 of treatment. Laboratory tests showed ALT 2 763 U/L, AST 1 291 U/L, ALP 115 U/L, γ-GT 365 U/L, TBil 65.9 μmol/L, and DBil 41.4 μmol/L. Drug-induced liver injury was considered. Oxcarbazepine and tiopronin were stopped, topiramate 50 mg once daily was given orally (changed to 50 mg twice daily 1 week later), and the liver-protective treatments such as diammonium glycyrrhizinate and reduced glutathione were given. The liver function of the patient gradually improved. After 20 days, his liver function basically returned to normal (ALT 38 U/L, AST 30 U/L, ALP 71 U/L, γ-GT 84 U/L, TBil 13.4 μmol/L, and DBil 5.5 μmol/L). Long-term use of topiramate orally was advised by doctor. At 3 months of follow-up, the patient had no seizures and his liver function stayed normal.
  • Zhang Xiaolan, He Chuan, Zhao Ping, Jiang Yiguo
    Adverse Drug Reactions Journal. 2019, 21(6): 469-470. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.022
    A 77-year-old female patient received combined antiplatelet therapy with aspirin enteric-coated tablets (100 mg once daily) and clopidogrel (75 mg once daily) orally because of acute ischemic stroke. Three days after medication, she developed rashes all over the body, accompanied by itching. No treatment was given. Three weeks later, clopidogrel was stopped and single antiplatelet therapy (aspirin enteric-coated tablets 100 mg once daily) was given. After that, the rashes did not subside for more than a month. Aspirin was stopped by herself. About 1 week later, the rashes subsided. Then the patient took original dose of aspirin again by herself for about 1 month, the above-mentioned symptoms recurred. Because she needed long-term single antiplatelet therapy, aspirin desensitization was given. Firstly, aspirin enteric-coated tablets were dissolved in warm water to make up the solution of 5 mg/ml. After the initial oral administration of 0.2 ml (equivalent to aspirin 1 mg), 1, 2, 4, 8 and 20 ml (equivalent to aspirin 1, 5, 10, 20, 40 and 100 mg) were given orally at 30, 60, 90, 210 and 330 minutes, respectively. The desensitization therapy lasted 5.5 hours. Anaphylactic reaction did not appear during the process of desensitization therapy. Then she took original dose of aspirin enteric-coated tablets followed the doctor′s advice. At 4 months of follow-up, rashes did not recur, suggesting that desensitization therapy was successful.
  • iu Xuejia1, Yao Difei2, Dong Zhanjun1
    Adverse Drug Reactions Journal. 2019, 21(1): 57-58.
    A 25-year-old male patient with epithelioid hemangioendothelioma received periodic chemotherapy with gemcitabine 1 600 mg (on day 1 and 8 of each chemotherapy cycle) and docetaxel 110 mg (on day 8 of each chemotherapy cycle) and the chemotherapy cycle was 21 days. The patient developed fever on day 7 after the first IV infusion of gemcitabine in the third chemotherapy cycle and then the following infusions of this cycle was abandoned. Thirty days later, he was hospitalized in the Second Affiliated Hospital of Zhejiang University School of Medicine to undergo the fourth chemotherapy cycle. On day 4 after hospitalization, the patient developed urinary incontinence and 900 ml of soy sauce-colored liquid was drained by catheter. Laboratory tests showed red blood cell count 2.19×1012/L, hemoglobin 63 g/L, and platelet 257×109/L. The patient was diagnosed as hemolytic-uremic syndrome due to gemcitabine. The patient′s condition improved after IV infusions of alprostadil injection, reduced glutathione for injection, and suspended red blood cells for 6 days.
  • Du Xian, Ye Yinmei, Sun Peihuan, Cai Jiangxia, Yan Xinchun
    Adverse Drug Reactions Journal. 2019, 21(2): 144-145. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.02.015
    A 77-year-old female patient with type 2 diabetes mellitus mistakenly injected insulin aspart 16 U subcutaneously as glargine insulin before bedtime. One hour later, she developed slow response and paraphasia. Her urgent blood glucose level was 2.8 mmol/L. An IV injection of 50% glucose injection 40 ml, mask oxygen absorption, and continuous ECG monitoring were given immediately. Thirty minutes later, her blood glucose level increased to 8.4 mmol/L. The adjusted hypoglycemic regimen was subcutaneous injection of 8, 10, and 8 units of insulin aspart 15 minutes before 3 meals, respectively, and glargine insulin 18 U before bedtime. Six days later, her fasting and 2-hour postprandial blood glucose levels were 7.0-8.3 mmol/L and 9.1-10.2 mmol/L, respectively.
  • Adverse Drug Reactions Journal. 2019, 21(1): 1-1. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.001
  • Zhang Wanqin, Zhu Fang
    Adverse Drug Reactions Journal. 2024, 26(1): 56-58. https://doi.org/10.3760/cma.j.cn114015-20230130-00038
    A 66-year-old male patient intermittently drank soading water of Tephroseris kirilowii by himself to alleviate skin itching caused by scabies. After nearly 2 years, he developed symptoms of abdominal distension, abdominal pain, poor appetite, and yellow urine. Laboratory tests showed total bilirubin (TBil) 158.2-μmol/L, direct bilirubin (DBil) 73.5 μmol/L, alanine aminotransferase (ALT) 96-U/L, aspartate aminotransferase (AST) 131-U/L, cholinesterase 1.40 kU/L, and international normalized ratio (INR) 1.7. Magnetic resonance imaging examination of upper abdomen showed consistent performance with the manifestation of hepatic sinusoidal obstruction syndrome. After excluding other causes, it was considered that it was caused by Tephroseris kirilowii. Supportive treatments such as anti-infection, liver protection, diuresis, nutritional support, anticoagulation, and reducing portal vein pressure were given. But the patient′s symptoms continue to worsen, with intermittent complications such as hepatic encephalopathy and gastrointestinal bleeding. After 67 days of treatments, laboratory tests showed TBil 192.0-μmol/L, DBil 96.7-μmol/L, ALT 118-U/L, AST 193-U/L, and cholinesterase 0.72 kU/L. The patient was discharged upon request from himself and the families, and died 5 days later.
  • Zhang Manman, Shen Wei
    Adverse Drug Reactions Journal. 2023, 25(9): 527-532. https://doi.org/10.3760/cma.j.cn114015-20230302-00139
    Objective To investigate the use of epinephrine in the treatment of anaphylaxis in the hospital. Methods The adverse drug reaction (ADR) reports of anaphylaxis in National Center for ADR Monitoring of China reported by Suqian First People Hospital from August 12, 2016 to November 30, 2022 were retrospectively analyzed. Patients with anaphylaxis were divided into shock group and non-shock group according to whether they had shock. The basic information, organs and systems involved, and severity of anaphylaxis, epinephrine use, and outcomes in patients of the 2 groups were compared. The application of epinephrine in patients with anaphylaxis of different manifestations, and the rationality of the dose and route of epinephrine were analyzed and evaluated descriptively. Results A total of 132 patients with anaphylaxis were entered in this study, including 62 males (47.0%) and 70 females (53.0%), with a median age of 53 years. There were 20 patients (15.2%) in the shock group and 112 patients in the non-shock group (84.8%). In comparison of the involving organs and systems in the anaphylaxis between the 2 groups, the cardiovascular system [100% (20/20) vs. 17.9% (20/112)], nervous system [60.0% (12/20) vs. 28.6% (32/112)], digestive system [40.0% (8/20) vs. 15.2% (17/112)], and urinary system [15.0% (3/20) vs. 1.8% (2/112)] were affected more often in patients of the shock group, while skin and mucosa were affected more often in patients of the non-shock group [88.4% (99/112) vs. 60.0% (12/20)]. The differences were all statistically significant (all P<0.05). Only 21 (15.9%) of 132 patients with anaphylaxis used epinephrine in the treatment. The proportion of patients receiving epinephrine in the shock group was significantly higher than that in the non-shock group [50.0% (10/20) vs. 9.8% (11/112), P<0.001]. Of the 21 patients who used epinephrine, 10 (47.6%) had excessive dose, and 11 (52.4%) received through subcutaneous injection, which was not recommended in the guidelines. Conclusions In the emergency treatment of anaphylaxis in patients in the Suqian First People Hospital, the proportion of epinephrine use is low, and there are also situa- tions that the dosage and administration route are unreasonable. The awareness on the importance of rational use of epinephrine should be improved in medical staffs, and relevant training should be strengthened.
  • Zhou Tiantian, Zhang Haiping
    Adverse Drug Reactions Journal. 2023, 25(9): 533-537. https://doi.org/10.3760/cma.j.cn114015-20230301-00137
    Objective To understand the current situation of skin tests before treatment with benzathine benzylpenicillin adviced by doctors of Dermatology Department on syphilis patients in China. Methods A self-designed survey questionnaire was used, which included content of 3 aspects: basic information of the respondents (question 1), the time of the skin test in syphilis patients who were schedule to receive treatment with benzathine benzylpenicillin (question 2), and the issues and suggestions regarding the current skin test method of benzathine benzylpenicillin (question 3). Based on the Collaborative Study Group on Psychodermatology of the Psychosomatic Medicine Branch of the Chinese Medical Association, the survey was conducted through online questionnaires and domestic doctors of Dermatology Department participated voluntarily. The investigation period was from July 2, 2021 to August 16, 2021. The obtained information was analyzed descriptively. Results A total of 366 electronic questionnaires were collected, of which 358 were confirmed to be valid, with a recovery rate of 97.8%. The 358 doctors of Dermatology Department were from 247 medical institutes in 20 provinces, 4 municipalities, and 4 autonomous regions across the country, including 129-3A-level first-class hospitals. The top 3 areas in number of respondents were Beijing (148 respondents, 41.3%), Yunnan province (42 respondents, 11.7%), and Henan province (25 respondents, 7%). Among the 358 doctors, 222 (62.0%) chose "conduct skin test weekly before injection of benzathine benzylpenicillin", 102 (28.5%) chose "in continuous injection, no further skin test is required for re-injection within 7 days", 33 (9.2%) chose "in continuous injection, no further skin test is required for re-injection within 72-hours", and 1 (0.3%) chose "other" and then added "further skin test is required after 48-hours of discontinuation". Compared with other medical institutions, there was a higher proportion of doctors (32.5%, 64/197) chose "in continuous injection, no further skin test is required for re-injection within 7 days" in hospitals of 3A-level first-class. Ninety one doctors (25.4%) answered question 3, all of whom believed that the current status of skin tests of benzathine benzylpenicillin had caused confusion in clinical treatment and some doctors provided suggestions such as developing standards for skin tests of benzathine benzylpenicillin and adding controlled trials. Conclusions The skin test time window and operation have not been standardized in the treatment of syphilis with benzathine benzylpenicillin in China, which hinders the standar- dized treatment of syphilis. It is urgent to develop guidance documents for the skin test of benzathine benzylpenicillin.
  • Xue Zhimin, Fan Huixia, Gao Ming′e, Lu Taotao
    Adverse Drug Reactions Journal. 2025, 27(3): 169-175. https://doi.org/10.3760/cma.j.cn114015-20240428-00283
    Objective To analyze the current preparation and usage situation of first-aid drugs in the rescue vehicles in children′s medical institutions, and provide references for optimizing the list of emergency drugs. Methods First-aid drug lists in the rescue vehicles of 12 children′s medical institutions from 11 provinces and municipalities in China were collected through questionnaire surveys, and the drugs as well as their quantities were compared. The existing problems in the use of first-aid drugs in the 12 medical institutions were investigated by on-site interviews. The usage information of first-aid drugs in the rescue vehicles of the General Surgery and Cardiology Department of Shanxi Children′s Hospital from May 2022 to April 2023 was collected through the hospital information center, and usage frequency and dosage per patient of the drugs were calculated. Descriptive statistical analysis was conducted on the collected data. Results The first-aid drug lists in 12 hospitals were various, including 7 to 22 kinds of drugs and invol- ving a total of 23 drugs. These mainly included vasoactive drugs, cardiotonic drugs, antiarrhythmic drugs, antiangina and anti-ischemic drugs for the heart, antispasmodic drugs, diuretics, dehydrating drugs, sedative-hypnotic drugs, and glucocorticoids, all of which were injections. The drugs that were included in all the lists of 12 hospitals were epinephrine, dopamine, dexamethasone, furosemide, and atropine. The drug lists of different rescue vehicles throughout the hospital were the same in 4 hospitals, while the lists varied among departments based on their specific clinical needs in the other 8 hospitals. None of the 12?hospitals had a first?aid drug usage manual. The on?site interview results showed that, the existing problems about drug prepa- ration and use in rescue vehicles mainly involved the following 6 aspects: drug types, quantities, labels, storage, procurement, and usage. In Shanxi Children′s Hospital, the types and quantities of first?aid drugs in rescue vehicles of General Surgery Department and Cardiology Department were the same. There were 6 and 9 kinds of drugs were used in the 2 departments during rescue operations, respectively. The drugs that were never used in either department included promethazine, lidocaine, diazepam, phenobarbital, raceanisodamine, sodium bicarbonate, atropine, glucose, and calcium gluconate. Conclusions The phenomenon of unreasonable kinds and quantities of first?aid drugs in the rescue vehicles existed in the children′s medical institutions, and the drugs provided did not fully match the actual clinical needs. There was an urgent need for preparation guidelines and usage manuals of first?aid drugs that were suitable for children′s medical institutions to enhance the scientificity of drug supply and the correctness of usage.
  • Dai Biao, Wu Xiaoping, Xia Qingrong, Xu Yayun, Zhang Xulai, Cao Yin, Cheng Xialong
    Adverse Drug Reactions Journal. 2019, 21(4): 291-293. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.010
    A 71-year-old male patient received venlafaxine hydrochloride sustained-release capsules 75 mg once daily orally for organic depressive disorder. On day 3 after medication, he developed mild gingival pain. The dose of venlafaxine hydrochloride sustained-release capsules was increased to 150 mg daily because of his condition. Three days later, his gingival pain aggravated significantly. Venlafaxine hydrochloride sustained-release capsules was stopped and oral care was given. On day 4 after the drug withdrawal, his gingival pain disappeared.
  • Li Jinfeng, Qu Guanghong, Zhang Yuan
    Adverse Drug Reactions Journal. 2019, 21(5): 387-388. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.016
    A 31-year-old male patient received carbamazepine and mecobalamin for 2 weeks due to trigeminal neuralgia. After 15 days of drug withdrawal, the patient developed fever, sore throat, fatigue, and diffuse bright red maculopapular rashes in the trunk, accompanied by itching, which progressively worsen. Laboratory tests showed white blood cell count 13.1×109/L, neutrophil count 10.7×109/L, eosinophil count 0.5×109/L, C-reactive protein 807.5 mg/L, alanine aminotransferase 663 U/L, and aspartate aminotransferase 332 U/L. Drug-induced hypersensitivity syndrome was diagnosed in the clinical. Anti-allergic and liver-protective drugs such as methylprednisolone, human immunoglobulin, compound glycyrrhizin, reduced glutathione, and etc. were given. Nineteen days later, the symptoms improved and the patient was discharged. At 2 weeks of follow-up, the patient showed normal blood routine test and liver function test results. According to the drug labels and the literature, it was considered that the drug-induced hypersensitivity syndrome was likely to be caused by carbamazepine.
  • 不良事件
    . 2002, 4(3): 200-200.
  • ADE简报
    . 2001, 3(1): 52-52.
  • 政策法规
    . 2004, 6(6): 395-395.
  • Liu Limin, Li Hailiang, Pang Lu, Zhu Xu, Zhao Limei
    Adverse Drug Reactions Journal. 2019, 21(4): 309-310. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.019
    Two girls (patient 1, 10 years old; patient 2, 13 years old) received methimazole 10 mg orally twice daily for hyperthyroidism. They developed arthralgia on day 18 and day 20 after medication, respectively. The laboratory tests showed normal rheumatoid factor and negative anti-nuclear antibody. Arthritis syndrome caused by methimazole was considered. Methimazole was stopped in patient 1 immediately. The arthralgia disappeared 3 days after drug withdrawal, and then she was transferred to department of surgery for treatment of primary disease. Patient 2 received gradually reduced dose of methimazole (5 mg twice daily for 3 days, 5 mg daily for 2 days) firstly, but the arthralgia did not improve. Then methimazole was stopped. Four days later, her arthralgia relieved. Patient 2 received methimazole 2.5 mg every morning and 1.25 mg every night again because of recurrence of hyperthyroidism. Four months after remedication, the arthralgia recurred. Methimazole was stopped again and replaced by propylthiouracil 18.75 mg twice daily. Two weeks later, her arthralgia relieved and hyperthyroidism was well controlled. One month later, her arthralgia disappeared.
  • Zhu Yuanchao, Zhang Yatong, Liang Liang
    Adverse Drug Reactions Journal. 2024, 26(2): 111-117. https://doi.org/10.3760/cma.j.cn114015-20230621-00455
    Local anesthetics are a class of medications that can reversibly block the occurrence and transmission of sensory nerve impulses in the local administration area, which are widely used in clinic for skin and mucous membrane anesthesia, peripheral nerve block anesthesia, spinal nerve anesthesia, and the treatment of chronic pain. The adverse reactions of local anesthetics mainly include allergic reactions, cardiotoxicity, and neurotoxicity. The new dosage forms of local anesthetics include cutaneous administration and sustained-release formulations. The advantage of cutaneous administration is to achieve surface local anesthesia, avoid liver first pass effect, reduce local damage and stimulation caused by injection anesthesia, and improve patient tolerance. The sustained-release dosage form can help maintain a longer lasting anesthetic effect, avoid excessive blood drug concentration caused by rapid absorption of local anesthetic drugs, and thus reduce adverse drug reactions.
  • Deng Yating, Ding Liang, Wei Kaixing, Duan Ziyun, Yue Yaohui
    Adverse Drug Reactions Journal. 2024, 26(6): 337-346. https://doi.org/10.3760/cma.j.cn114015-20231220-00916
    Objective To systematically evaluate the effects of liver and kidney function on the occurrence of thrombocytopenia induced by linezolid and the population pharmacokinetic characteristics of linezolid, so as to provide guidance for the individualization of linezolid in patients with liver and renal insufficiency. Methods Relevant databases at home and abroad have been searched up to November 2023. The literature about the influence of liver and kidney function on linezolid-induced thrombocytopenia were analyzed using the Rev Man 5.4-statistical software, and the effect sizes were odds ratio (OR) and standardi- zed mean difference (SMD) with their 95% confidence interval (CI) in the meta-analysis. The literature on population pharmacokinetic studies of linezolid were summarized and systematically reviewed. Results A total of 32 literature were included in the meta-analysis, including 4-112 patients. Among them, 1-458 (35.5%) developed thrombocytopenia and 2-654 (64.5%) did not. The meta-analysis results showed that the risk of linezolid-induced thrombocytopenia in the renal insufficiency patients was higher than that in patients with normal renal function [47.9% (594/1-241) vs. 25.8% (493/1-912), OR=3.24, 95%CI: 2.31-4.53], and the lower baseline creatinine clearance (Ccr) and estimated glomerular filtration rate (eGFR) were associa- ted with the higher risk of linezolid-related thrombocytopenia (all P<0.05); the risk of thrombocytopenia induced by linezolid in patients with liver dysfunction was higher than that in patients with normal liver function [47.6% (119/250) vs. 33.9% (360/1-061), OR=2.36, 95%CI: 1.73-3.22], and the higher baseline total bilirubin (TBil) was associated with the higher risk of linezolid-related thrombocytopenia (all P<0.05). A total of 15 articles were included in the review of population pharmacokinetic study, 11 of which were based on self-built or publicly published population pharmacokinetic models and used Monte Carlo simulation to evaluate the efficacy and safety probabilities in different dosing regimens of linezolid. Among them, there were 5 and 2 articles optimized the dosing regimen of linezolid in patients with renal and liver insufficiency, respectively. Conclusions Liver and renal insufficiency increases the risk of linezolid-induced thrombocytopenia, and baseline levels of Ccr, eGFR, and TBil can serve as sensitive indicators for predicting the risk. Patients with liver and renal insufficiency can use population pharmacokinetic models for an optimized linezolid regimen before treatment to reduce the risk of linezolid-induced thrombocytopenia.
  • Tian Xu, Hou Jiqiu, Li Yanjiao, Zhang Hongmei
    Adverse Drug Reactions Journal. 2019, 21(4): 299-300. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.014
    A 62-year-old female patient received ramipril 2.5 mg orally once daily for hypertension. About 12 hours after the first administration, the patient developed difficulty breathing, multiple skin rashes all over the body (mostly on chest and back, accompanied with itching), conjunctival hyperemia, lip swelling, oral mucosal hyperemia, pharyngeal congestion with pain, and etc. She was diagnosed with angioedema, which was considered to be caused by ramipril. Ramipril was stopped and anti-allergy treatments with adrenaline, promethazine hydrochloride, and dexamethasone were given. One hour later, the patient had improved symptoms and stable vital signs. On day 2 after the anti-allergy treatments, the patient had neither difficulty breathing nor new skin rash, and the anti-allergy drugs were replaced by methylprednisolone, calcium gluconate, and desloratadine cirate disodium. Antihypertensive treatment with levoamlodipine was also given. On day 3 after treatments, the patient′s skin rashes subsided with scars, congestion of the conjunctiva, oral mucosa, and pharynx relieved, and the lip swelling improved. On day 6 after treatments, the patient′s allergic symptoms completely disappeared, and her blood pressure was 122/78 mmHg.
  • Wang Hongyan, Yang Xiaoliang, Jiao Jiao
    Adverse Drug Reactions Journal. 2019, 21(3): 208-212. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.009
    ObjectiveTo explore the influence of comprehensive intervention on efficacy and safety of antihypertensive therapy in patients with hypertension in the community health service center.MethodsThe subjects were from patients with hypertension who visited Sun Palace Community Health Service Center, Chaoyang District, Beijing from October 2017 to October 2018. The patients who met the criteria were randomly divided into the control group and the intervention group. Patients in the control group were treated only with conventional medication, while patients in the intervention group were treated with additional comprehensive intervention of non-drugs on the basis of conventional medication. After 1 year of treatment, the patients′ blood pressure and the proportion of patients with risk factors for hypertension such as smoking, drinking excess, high salt diet, insufficient exercise, overweight, Zung self-rating anxiety scale (SAS) score >40 and/or Zung self-rating depression scale (SDS) score >40 in the 2 groups before and after treatment were compared; the treatment compliance of conventional medication (taking drugs on time), efficiency of blood pressure control (systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg), incidence of adverse cardiovascular events (CAE), and incidence of adverse reactions related to antihypertensive drugs before and after treatment between the 2 groups were compared as well. ResultsA total of 400 patients were enrolled in the study(200 in the control group and 200 in the intervention group). There were no significant differences in gender, age, course of disease, hypertension grade, and combined diseases in patients between the 2 groups (all P>0.05). After 1 year of treatment, the systolic and diastolic blood pressures of patients both in the control group and in the intervention group were significantly lower than those before treatment (all P<0.05); the systolic and diastolic blood pressures of patients in the intervention group were significantly lower than those in the control group [(133±17) mmHg vs. (139±18) mmHg, (86±8) mmHg vs. (90±9) mmHg, all P<0.05]; the proportions of patients with risk factors such as smoking, drinking, high salt diet, insufficient exercise, overweight, SAS score >40 and/or SDS score >40 in the intervention group were significantly lower than those in the control group (all P<0.05); the proportion of patients who took drugs on time and efficiency of blood pressure control in the intervention group were significantly higher than those in the control group [82.5% (165/200) vs. 64.0% (128/200), 64.0% (128/200) vs. 52.5% (105/200), both P<0.05]; the incidence of cardiovascular adverse events in patients in the intervention group was lower than that in the control group [1.0%(2/200)vs. 6.5% (13/200), P<0.05]; the incidence of adverse reactions related to antihypertensive drugs in patients in the intervention group was lower than that in the control group[4.0%(8/200) vs. 10.0% (20/200), P<0.05].ConclusionComprehensive intervention could significantly improve the efficacy and safety of antihypertensive therapy in patients with hypertension in community health service center.
  • Hou Jiqiu, Zhang Hongmei, Xiao Jinbao, Li Ping
    Adverse Drug Reactions Journal. 2018, 20(6): 456-458. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.016
    A 46-year-old male patient with Hodgkin′s lymphoma received ABVD regimen with pingyangmycin, epirubicin, vindesine, and dacarbazine (the chemotherapy cycle was 28 days). After 4 cycles of chemotherapy, the patient developed obvious dyspnea, which became more serious after activity and did not improve after oxygen inhalation and glucocorticoid treatment. The chemotherapy regimen was changed to CHOPE regimen with cyclophosphamide, epirubicin, vindesine, prednisone, and etoposide (the chemotherapy cycle was 28 days). After 1 cycle of the CHOPE chemotherapy, the patient′s dyspnea aggravated. Blood oxygenation analysis showed pH 7.5, arterial oxygen partial pressure 51 mmHg, partial pressure of arterial blood carbon dioxide 32 mmHg, and blood oxygen saturation 0.89. A lot of Velcro rales could be auscultated in bilateral lungs. Chest CT examination showed bilateral pulmonary interstitial changes. Pulmonary interstitial fibrosis induced by pingyangmycin and cyclophospha-mide was considered. The patient was given treatments of IV infusions of methylprednisolone sodium succinate and ambroxol hydrochloride injection, and noninvasive mechanical ventilation. But his condition aggravated progressively and eventually died due to respiratory failure.
  • 不良事件
    . 2002, 4(2): 130-131.
  • Wang Bing, Wu Xiaoping, Li Jinfeng, Zhang Yuan
    Adverse Drug Reactions Journal. 2019, 21(3): 233-234. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.017
    A 31-year-old male patient received triple anti-rejection therapy (tacrolimus 3 mg once per 12 hours, mycophenolate sodium enteric-coated tablets 720 mg twice daily, and prednisolone acetate tablets 80 mg once daily) after his renal allotransplantation. On day 5 after operation, the blood trough concentration of tacrolimus was 4.90 μg/L. On day 7, he developed 5 watery stools and the blood trough concentration of tacrolimus was 8.62 μg/L. The clinical pharmacist considered the diarrhea was the postoperative response to renal allotransplantation and the increased blood trough concentration of tacrolimus might be caused by diarrhea. Montmorillonite powder 3.0 g thrice daily orally and an IV infusion of moxifloxacin sodium chloride injection 0.4 g once daily were given. On day 12 after operation, the patient experienced 8 watery stools and his blood trough concentration of tacrolimus increased to 13.78 μg/L. The dose of tacrolimus was adjusted to 2 mg and 1 mg at 8: 00 and 20: 00 respectively. On day 14 after operation, the patient's diarrhea relieved (3 watery stools) and the blood trough concentration of tacrolimus was 20.67 μg/L. The dose of tacrolimus was adjusted to 1 mg once per 12 hours. On day 18 after operation, no diarrhea occurred in the patient and the blood trough concentration of tacrolimus decreased to 9.63 μg/L. The patient was discharged in a stable condition. The post-discharge dose of tacrolimus was adjusted to 2 mg per 12 hours. The blood trough concentrations of tacrolimus in his 3 return visits were 9.12, 9.23, and 9.15 μg/L, respectively.
  • Zhang Tai, Wu Qiang, Wang Jin, Zhang Yunli
    Adverse Drug Reactions Journal. 2024, 26(4): 234-237. https://doi.org/10.3760/cma.j.cn114015-20230923-00702
    Dextran 40 is a commonly used pharmaceutical excipient and can be used as formulations of dry powder for injection. But it has antigenic properties that can trigger severe allergic reactions. Therefore, injections containing the excipient dextran 40 may have additional safety risks that are not easily recognized in the clinic. Dextran 40-associated allergic reactions may also interfere with the diagnosis of certain diseases and limit the choice of therapeutic drugs. Revision of the relevant instructions and improvement of the clinical dosing process can help reduce the risk of injections containing the excipient dextran 40 in clinical use. Physicians and pharmacists should expand their clinical and pharmacological thinking to evaluate the antigenicity of the excipient dextran 40 as an independent influence factor in the rational and safe use of medication. Identification individual cases of adverse events caused by this excipient and taking measures to minimize adverse events caused by this excipient in different drugs can help effectively reduce the risk of drug safety of the relevant formulations.
  • Zhao Weiwei, Zhao Liling, Xie Ruohan
    Adverse Drug Reactions Journal. 2025, 27(2): 91-98. https://doi.org/10.3760/cma.j.cn114015-20240722-00614
    Objective To understand the clinical characteristics of myelopathy induced by intrathecal chemotherapy of methotrexate (MTX) and/or cytarabine (Ara-C). Methods Relevant databases at home and abroad (up to February 18, 2024) were searched and case reports of myelopathy induced by intrathecal chemotherapy of MTX and/or Ara-C were collected. The patients′ general situation (gender, age, primary disease, etc.), use of MTX and/or Ara-C, previous radiotherapy, and occurrence time, clinical manifestations, spinal magnetic resonance imaging (MRI) results, cerebrospinal fluid test results, treatments and outcomes of myelopathy were extracted and analyzed descriptively and statistically. Results A total of 75 articles were enrolled, involving 104 patients, with 62 males, 35 females, and 7 unknown genders. Their ages ranged from 1 to 74 years, with a median age of 26 years. The primary diseases included hematological malignancy in 101 cases, and other solid tumors in 3 cases. Before the occurrence of myelopathy, 42 cases had central nervous system tumor infiltration. Seventy-three patients received intrathecal injection of MTX combined with Ara-C, 21 patients received single MTX therapy, 10 patients received single Ara-C therapy. The number of intrathecal injections ranged from 1 to 62, with a median of 5 injections. Twenty-nine patients had received radiotherapy before. When myelopathy occurred, the cumulative dose of MTX was 7.5-480.0 mg, with a median cumulative dose of 60.0 mg; the cumulative dose of Ara-C was 15 1 599 mg, with a median cumulative dose of 280 mg. The onset time of myelopathy was from immediately to 365 days after the last intrathecal injection, with a median time of 2 days. The main clinical manifestations were weakness of both lower limbs, urinary and fecal incontinence or retention, paresthesia, and paraplegia, etc. Fifty-three patients had spinal abnormality in MRI examination, 32 had abnormal cerebrospinal fluid protein quantity, intrathecal basic protein, or homocysteine. After the diagnosis of myelopathy, 86 patients were treated with drugs, radiotherapy, plasma exchange, and cerebrospinal fluid exchange, and 18 patients had no record of treatment situation. Therapeutic agents included glucocorticoids, B vitamins, folic acid, immunoglobulin, leucovorin, S-adenosylmethionine, and dextromethorphan. Of the 104 patients, 20 achieved complete remission, with a median remission time of 30 hours; 25 experienced partial remission, with a median duration of 120 days; 32 showed no significant improvement; 26 died; one patient′s prognosis and outcome were unknown. Conclusions The median occurrence time of myelopathy induced by intrathecal injection of MTX and/or Ara-C is 2 days. The main clinical manifestations are bilateral lower extremity weakness, urinary and bowel incontinence or retention, paresthesia, and paraplegia, etc. Abnormal spinal in MRI examination, quantitative cerebrospinal fluid protein, intrathecal basic protein occurred in some patients. Intrathecal injection should be stopped immediately after diagnosis of myelopathy, and the treatments such as drug and cerebrospinal fluid replacement should be given. The clinical outcome of myelopathy induced by intrathecal MTX and/or Ara-C was poor.
  • Ye Jing, Hang Yongfu, Xie Cheng
    Adverse Drug Reactions Journal. 2019, 21(3): 239-240. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.03.020
    A 44-year-old female patient with chronic kidney disease (stage 5) undergoing peritoneal dialysis received an IV infusion of vancomycin 500 mg once per 12 hours for infective endocarditis. Vancomycin was discontinued before the third administration for its frequency of administration was found inappropriate. The blood concentration of vancomycin was higher than 50 mg/L at 12 hours after the second dose. The blood concentration of vancomycin dropped to 9.2 mg/L after drug withdrawal and persistent peritoneal dialysis for 24 days. No other obvious adverse reactions related to vancomycin during this period.
  • Liu Jinyu1,2, Chen Xiaoqian1,2, Wang Wenjie1,2, Li Chunhua3, Ni Jianqiang1, Xue Qun1, Xu Min1,
    Adverse Drug Reactions Journal. 2019, 21(1): 72-74. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.019
    Two male patients (patient 1, 30 years old; patient 2, 54 years old) were treated with topiramate for symptomatic epilepsy and migraine, respectively. The dosage of topiramate in patient 1 was 50 mg/d and 75 mg/d in the first and second weeks, respectively, and 100 mg/d since the third week. Six months after topiramate treatment, the patient told the doctor that his epilepsy did not recur, but he developed hypomnesia, decreased libido, and premature ejaculation when topiramate was taken for 2 weeks. He did not stop topiramate despite that his symptoms persisted. The International Index of Erectile Function (IIEF) score showed that IIEF-1 score was 19 and IIEF-5 score was 16. He was diagnosed as sexual dysfunction. Levetiracetam was given for epilepsy, and topiramate was gradually reduced and finally discontinued within one month. The patient′s sexual dysfunction improved after 2 weeks of topiramate reduction, disappeared after one month of drug withdrawal, and the IIEF-1 score was 28. The patient 2 took topiramate at a dose of 50 mg/d. After 2 weeks of topiramate treatment, the patient developed decreased libido and erectile dysfunction. The IIEF-1 score was 23. Because the drug was effective in treating his headache, the patient took topiramate intermittently during headache attacks. The patient′s anaphrodisia and erectile dysfunction persisted.
  • Yang Jing, Dai Yang, Fan Hua, Wang Huaguang, Liu Lihong
    Adverse Drug Reactions Journal. 2018, 20(6): 468-470.
    A 50-year-old female patient received  mechanical ventilation via tracheal cannula and continuous venous pump of propofol 1.2 mg/(kg·h) for sedation in surgical intensive care unit (SICU) after liver transplantation. On day 4 after the operation, the ventilator and propofol were discontinued and laboratory test showed myoglobin (Mb) 1 345 μg/L. On day 6 after the operation, the Mb level decreased to 803 μg/L. And on the same day, the mechanical ventilation via tracheal cannula and continuous venous pump of propofol 1.538 mg/(kg·h) for sedation was given again because of pleural effusion and atelectasis. After that, the patient′s Mb level keep increasing and, on day 10 after the operation, it increased to 1 465 μg/L. Propofol was stopped and the Mb level decreased to 638 μg/L 4 days later and then 320 μg/L 11 days later.
  • Deng Yufei, Wang Liping, Cao Hongfu, Zhao Yin, Wang Xiaodan
    Adverse Drug Reactions Journal. 2019, 21(6): 451-453. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.013
    A 92-year-old male patient received bladder irrigation with amphotericin B 25 mg dissolved in sterilized water for injection 250 ml once daily for Candida tropicalis urinary system infection. On day 3 to 5 of the treatment, the patient had a fever around 16:00 every day and the temperature was up to 38.0 ℃.On day 5, laboratory tests showed white blood cell (WBC) 7.2×109/L, neutrophil 0.67, eosinophils 0.015,and C-reactive protein 0.18 mg/L. Drug fever due to bladder irrigation with amphotericin B was considered. Amphotericin B was stopped. Twenty-four hours after the drug withdrawal, his body temperature decreased to 37.6 ℃. Forty-eight hours after the drug withdrawal, his body temperature returned to normal. Laboratory tests showed WBC 6.2×109/L, neutrophil 0.66, and eosinophils 0.034.
  • Zhang Li‘na, Wang Quan, Gao Jian, Fang Wei, Gao Na, Li Jinfeng
    Adverse Drug Reactions Journal. 2025, 27(3): 190-192. https://doi.org/10.3760/cma.j.cn114015-20240510-00331
    A 52-year-old male patient with recurrent Hodgkin′s lymphoma was treated with a combination therapy of gemcitabine, oxaliplatin, and sintilimab for 6 cycles, and sintilimab monotherapy for 15 cycles. Because of disease progression, the therapy was switched to decitabine (10 mg intravenous infusion on day 1-5) and penpulimab (200 mg intravenous infusion on day 8), with 21 days as one cycle. On the 5th day after the last administration of the 10th cycle, the patient experienced discomfort such as headache and poor appetite; on the 7th day, he suddenly developed unconscious and faint. The patient had a body temperature of 38.1 ℃ and mild yellowish skin and mucous membranes throughout the body. Laboratory tests showed platelet count 9×109/L, red blood cell count 4.1×1012/L, hemoglobin 113 g/L, pro- thrombin time 15.6 s, blood creatinine 101.6 μmol/L, total bilirubin 61.1 μmol/L, and creatine kinase isoenzyme 43 U/L. Based on laboratory and imaging examinations, immune checkpoint inhibitors causing acquired thrombotic thrombocytopenic purpura was considered. The patient underwent 3 times of plasma exchanges, and received intravenous infusion of methylprednisolone 80 mg once daily and other symptomatic treatments for 5 days. The patient′s yellowish skin and mucous membranes throughout the body disappeared. The glucocorticoid was decreased gradually. Two months later, the patient′s laboratory test indicators such as platelet count and total bilirubin returned to normal.
  • Huang Jiaoyuan, Qin Zixiang, Li Liang, Zhang Tao
    Adverse Drug Reactions Journal. 2024, 26(12): 759-762. https://doi.org/10.3760/cma.j.cn114015-20240102-00001
    A 55-year-old female patient with ovarian cancer received bevacizumab (intravenous infusion of 400 mg on day 1) and paclitaxel liposomes (intravenous infusion of 180 mg on day 1) 9 years after surgery due to disease progression, with 21 days as a cycle of chemotherapy. Due to the improvement of the  patient′s general condition, the chemotherapy regimens for the 3rd and 4th cycles were adjusted to addtionally give intravenous infusion of carboplatin 500 mg on day 1, and in the 5th cycle, the dose of bevacizumab was increased to 700 mg. Starting from the 2th cycle of chemotherapy, after each intravenous infusion of paclitaxel, the patient immediately experienced itching symptoms on the distal skin of both upper limbs, which were mild and could be relieved on their own. After the 5th cycle of chemotherapy, the patient′s itching symptoms worsened progressively. Four days later, keratinization of the skin on both hands and forearms of upper limbs appeared, with tight skin and waxy luster, gradually developing towards the proximal end. The modified Rodnan skin score was 1-2 (mild to moderate skin thickening). Laboratory tests showed positive results for anti-nuclear antibodies and anti-centromere antibodies.Pathological examination of skin biopsy tissue of the right forearm showed dermal fibrosis, involving subcutaneous adipose tissue and epidermal atrophy. It was considered to be localized cutaneous systemic sclerosis caused by paclitaxel liposomes. Paclitaxel liposomes was stopped and anti-inflammatory and topical application of glucocorticoids locally treatments were given for 3 days, the patient′s itching symptoms were improved. At a 2-month follow-up, the patient′s itching symptoms were improved and did not recur.
  • Adverse Drug Reactions Journal. 2025, 27(1): 1-1. https://doi.org/10.3760/cma.j.cn114015-20241127-00170
  • Yu Jie, Xu Nan, Yang Miao, Li Meng, Lan Gaoshuang, Li Zhengxiang, Yuan Hengjie
    Adverse Drug Reactions Journal. 2024, 26(8): 467-473. https://doi.org/10.3760/cma.j.cn114015‑20240321‑00182
    Objective To investigate the clinical features, management, and prognosis of amphotericin B (AmB)?associated nephrogenic diabetes insipidus (NDI). Methods The diagnosis and treatment process of a patient with AmB?related NDI who was admitted to the General Hospital of Tianjin Medical University was reported, and the main clinical data of the patient and related cases such as gender, age, primary disease, medication, NDI occurrence, treatment and outcome collected from CNKI, Wanfang Medical, and VIP databases, PubMed, Web of Science, and ScienceDirect (up to August 22, 2023) were analyzed descriptively. Results A total of 11 patients were included in the analysis, including 7 males and 4 females, with an average age of 41 years, ranging from 12 to 66 years. The correlation between AmB and NDI was probable in 7 cases and possible in 4 cases. The time from the beginning of medication to the occurrence of NDI was 3 days to 3 weeks, and the urine volume was 3.8-10.8 L/d. Among the 11 patients, 6 patients had hypokalemia and 5 patients had elevated serum creatinine; 9 patients did not stop using AmB due to their conditions, the intervention plans were described in details in 4 patients and AmB treatments were completed after symptomatic treatments, 7 patients were cured or improved, and 2 patients died. Among the 2 patients who stopped taking the medication, 1 patient showed significant improvement in symptoms and resumed using AmB without recurrence; the other case was improved after stopping the medication, but relapsed after resuming use without stopping the medication, and the patient died from the primary disease. Conclusions During the use of AmB, close attention should be paid to the occurrence of NDI. After occurrence of NDI, most patients can continue taking the AmB and have a good prognosis after symptomatic treatments.

  • Zong Yutong, Wang Huaguang, Zhang Xingmao, Fan Hua, Liu Lihong
    Adverse Drug Reactions Journal. 2019, 21(6): 445-447. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.010
    A 50-year-old female patient received immunosuppressive treatment with tacrolimus after liver transplantation. Eighty-seven days later, tacrolimus was replaced by oral cyclosporine 75 mg twice daily due to liver injury. Nine days after cyclosporine treatment, she had an epileptic seizure. Antiepileptic drugs such as diazepam were given and the symptoms were relieved. But epilepsy still attacked sometimes on the next 3 days and it was considered to be reversible posterior leukoencephalopathy syndrome caused by cyclosporine, based on the CT examination of the head. The dose of cyclosporine was reduced and finally replaced by tacrolimus. The patient′s seizure was gradually reduced and finally disappeared after 8 days of tacrolimus treatment.
  • Fu Zhengran1, Wang Xiaoling1, Bian Guangbo2, Fang Fang3
    Adverse Drug Reactions Journal. 2019, 21(1): 67-68. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.016
    A 2 years and 4 months old boy mistakenly took 10-20 tablets of compound diphenoxylate hydrochloride placed by his parents at the bedside. About 2 hours after taking the medicine by mistake, the boy developed lethargy and, about 3 hours after the medicine, he developed cyanosis of lips and lethargy accompanied by snoring. About 6 hours after the medicine, the boy was sent to the local hospital and treatments such as gastric lavage and oxygen inhalation were given. About 9 hours after the medicine, the boy was transferred to the General Hospital of Ningxia Medical University. After 7 days of symptomatic and supportive treatments, such as mechanical ventilation via tracheal intubation, naloxone rescue, fluid replacement, and diuresis, the consciousness of the child improved and he could breathe spontaneously. However, the boy still had high muscle tension of his limbs, exaggerated bilateral tendon reflexes, positive Babinski sign, positive ankle clonus, and intermittent paroxysmal postural abnormalities. The head Magnetic Resonance Imaging showed multiple abnormal signal foci in bilateral cerebellar hemisphere, parieto-occipital lobe, peri-lateral ventricle, anterior and posterior periventricular and corpus callosum. He was diagnosed as toxic encephalopathy and symptomatic epilepsy. One year later, it was known by telephone follow-up that the boy had severe mental retardation.
  • 药物安全动态
    . 2006, 8(2): 153-153.
  • 不良事件
    . 2002, 4(5): 346-346.
  • Zhang Jianping, Yang Zhongxia, Zhao Rongrong, Li Boxia
    Adverse Drug Reactions Journal. 2024, 26(7): 399-404. https://doi.org/10.3760/cma.j.cn114015‑20240109‑00019
    Objective To explore the efficacy and safety of sodium stibogluconate (SSG) andliposomal amphotericin (L‑AmB) as well as their combination regimen in the treatment of Kala‑azar (alsoknown as visceral leishmaniasis) in China. Methods Clinical data of patients with Kala‑azar hospitalizedin the First Hospital of Lanzhou University from January 2012 to December 2021 were collected, includingpatient demographic information, clinical characteristics of Kala‑azar, previous treatment history, therapeuticdrugs, clinical efficacy and adverse drug reactions (ADRs) in the treatment. The clinical characteristics, effi‑cacy and occurrence of ADRs related to SSG and L‑AmB in patients treated with SSG (SSG group) andL‑AmB or SSG+L‑AmB (L‑AmB or SSG+L‑AmB group) were analyzed by descriptive statistics. ResultsA total of 44 patients were included in the analysis, including 25 males and 19 females; 25 were children(56.8%) and 19 were adults (43.2%). Thirty‑seven patients (84.1%) were treated with SSG (SSG group),which was used as an initial treatment in 32 patients and was used also in previous treatment in 5 patients.Seven patients (15.9%) were treated with L‑AmB, including 2 with L‑AmB monotherapy and 5 with SSG+L‑AmB, and all of them have been treated with SSG before. Among the 32 patients used SSG as initial treat‑·399·药物不良反应杂志 2024 年7月第 26 卷第7期 ADRJ,July 2024, Vol. 26, No. 7ments in the SSG group, 29 (90.6%) were clinically cured. All the 5 patients, who had been treated before,were also clinically cured after prolonged treatments. Seven patients in the L‑AmB or SSG+L‑AmB groupwere treated with a low‑dose and long‑term L‑AmB regimen, and all of them were cured without Kala‑azarrecurrence. The common ADRs of SSG were abnormal liver function and elevated pancreatic enzymes; thecommon ADRs of L‑AmB were hypokalemia and mild elevation of serum creatinine. Conclusions Theefficacy of SSG in initial treatment of patients with Kala‑azar is more than 90%, and it can still be used asthe preferred drug to treat Kala‑azar. The monitoring of liver function and pancreatic enzymes should be paidattention to during the treatment. For patients that have been treated before, especially those with multipleKala‑azar recurrences, L‑AmB or SSG+L‑AmB should be advised. Low dose and long‑term administrationof L‑AmB can obtain better efficacy and reduce the risk of ADR, and electrolytes and renal function shouldbe monitored during the treatment.
  • Chen Minting, Liu Yan, Ma Jie, Zheng Ke
    Adverse Drug Reactions Journal. 2024, 26(9): 563-565. https://doi.org/10.3760/cma.j.cn114015-20231023-00751
    A 53‑year‑old female patient with bone metastasis of breast cancer received targeted drugs (abemaciclib 150 mg orally twice daily, exemestane 25 mg orally once daily), zoledronic acid (4 mg IV infusion once per month), traditional Chinese medicine, and non‑steroidal anti‑inflammatory drugs. After 2 months, her serum creatinine (Scr) increased from 84 μmol/L before treatment to 156 μmol/L. Due to renal tissue puncture biopsy, the patient missed taking abemaciclib for 1 day. The laboratory tests next day showed that her Scr decreased from 151 μmol/L to 123 μmol/L. Comparing the estimated glomerular filtration rate calculated using serum cystatin C with that calculated using Scr, combined with the pathological examination results of renal biopsy tissue, the patient′s renal injury caused by other drugs could be ruled out, and the possibility of pseudo‑elevation of Scr caused by abemaciclib was considered.
  • Adverse Drug Reactions Journal. 2019, 21(5): 322-322. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.002
  • Adverse Drug Reactions Journal. 2019, 21(1): 77-77. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.022
  • Wei Anhua, Wang Lu, Zeng Lu, Li Wei, Gong Xuepeng, Liu Dong
    Adverse Drug Reactions Journal. 2025, 27(1): 6-10. https://doi.org/10.3760/cma.j.cn114015-20240603-00409
    Objective To explore the effect of concomitant amiodarone on the bleeding risk in atrial fibrillation patients treated with dabigatran etexilate. Methods This study was a retrospective cohort study. The clinical data of hospitalized patients with atrial fibrillation who took dabigatran etexilate in Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology from July 1, 2022 to June 30, 2023 were collected. Patients were divided into concomitant amiodarone group and non concomitant amiodarone group according to whether they were treated with oral amiodarone. Propensity score matching (PSM) was performed at a 1∶1 ratio in patients between the 2 groups according to patient's gender, age, main basic diseases and the number of basic diseases, baseline liver and kidney function, dosage of dabigatran etexilate, etc. The incidence of bleeding events was compared between the 2 groups. Results A total of 878 patients were included in the study, including 568 males (64.7%) and 310 females (35.3%), with a age of 67 (59, 74) years. There were 252 patients (28.7%) in the concomitant amiodarone group and 626 patients (71.3%) in the non concomitant amiodarone group. Within 3 months of follow-up, the incidence of bleeding events in patients of concomitant and non concomitant amiodarone groups were 19.0% (48/252) and 21.2% (133/626), respectively, which were 19.0% (48/252) and 16.7% (40/239) after PSM, respectively, with no significant difference (all P>0.05). The main type of bleeding in patients of both groups was mild bleeding events [62.5% (30/48) vs. 67.5% (27/40)], and bleeding was more common in the gums, skin, and nose. There was no statistically significant difference in incidence of the bleeding types and bleeding sites of patients between the 2 groups (all P>0.05). Conclusions Compared with patients with atrial fibrillation when treated with dabigatran etexilate and without concomitant amiodarone, the bleeding risk of patients with amiodarone did not significantly increased in the short term. The bleeding events during treatment of dabigatran etexilate were mainly mild bleeding, but clinical vigilance was still necessary.
  • Wu Guiying, Mu Guilan, Wuriliga, Li Hongbin, Wang Yong, Bai Lijie
    Adverse Drug Reactions Journal. 2025, 27(3): 188-189. https://doi.org/10.3760/cma.j.cn114015- 20240103- 00002
    A 38- year- old male patient with ankylosing spondylitis received subcutaneous injection of adalimumab 40 mg once every 2 weeks. After 21 months of medication, the patient developed fever, fatigue, swelling, and pain in the right neck lymph node and throat. Laboratory tests showed that the tuberculin test was strong positive, mycobacterium tuberculosis γ- interferon release test was 1  911.98  ng/L, and erythrocyte sedimentation rate was 27  mm/1 h. The biopsy of right neck lymph node showed granulomatous inflammation of the lymph node. The patient was diagnosed with cervical lymph node tuberculosis, which was considered to be related to adalimumab. The drug was stopped and anti-tuberculosis treatments were given. The next day, the patient′s temperature returned to normal. After 5 days, the swelling and pain of cervical lymph nodes and throat, and the fatigue were relieved gradually. After 45 days, the above symptoms in the patient disappeared.
  • Hao Xinyu, Zhang Lin, Zhao Jiani, Lyu Jing, Zhao Lei, Zhao Yiru, Zhang Caihui, Zhang Yueying
    Adverse Drug Reactions Journal. 2024, 26(10): 594-600. https://doi.org/10.3760/cma.j.cn114015-20240403-00227
    Objective To summarize the relevant evidence for the prevention of contrast-associated acute kidney injury (CA-AKI) after enhanced CT examination in patients with nephropathy. Methods The literature on prevention of CA-AKI in patients with nephropathy who underwent enhanced CT examination in relevant websites and medical literature databases at home and abroad were systematically searched, the quality of the literature was evaluated, and the relevant evidence was extracted and summarized. The retrieval period was from January 1, 2013 to December 1, 2023. Results A total of 17 literature was included, including 6 guidelines, 5 expert consensuses, 2 clinical decisions, 2 cohort studies, 1 evidence summary and 1 systematic review. Evidence was extracted from these literature. After summary and analysis of these evidence, 10 evidence topics were sorted out, including threshold of estimated glomerular filtration rate and high-risk population, screening, hydration prevention, drug prevention, use of nephrotoxic drugs, use of metformin, precautions for dialysis patients, alternative imaging strategies, choice of iodine contrast agents, and points for attention after enhanced CT examination, forming 47 pieces of evidence. Conclusion The relevant evidence for the prevention of CA-AKI can provide a more systematic evidence- based basis for medical staffs in screening high-risk population and preventing and managing CA-AKI in patients with chronic kidney disease before enhanced CT examination.
  • Li Yueyang1, Wang Yan2, Zhao Hongwei1, Zhang Yongkai1
    Adverse Drug Reactions Journal. 2019, 21(1): 62-64. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.01.014
    A 65-year-old male patient received oral Anweiyang capsules 0.4 g four times daily for chronic gastritis. About 1 month after the medication, the patient developed intermittent headache, dizziness, and increased blood pressure, whose highest value was 180/100 mmHg. Levamlodipine besylate tablets 2.5 mg once daily was given orally but the patient′s blood pressure was not well controlled. About 4 months later, laboratory tests showed obviously increased free cortisol in urine (2 330 nmol/24 h), which was considered to be caused by Anweiyang capsules. Anweiyang capsules were stopped and the patient continued to take levamlodipine besylate tablets. On day 4 after the drug withdrawal, the patient′s blood pressure and urinary free cortisol began to decrease, which finally returned to normal on day 9. At 1 month of follow-up, no abnormalities were found on the blood pressure and urinary free cortisol in the patient.
  • ang Xuemin, Shen Baorong, Liu Pengyuan, Yang Kaining, Zhao Qian, Wang Mengmeng
    Adverse Drug Reactions Journal. 2019, 21(5): 389-390. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.017
    A 30-year-old female patient received oral rifampicin 0.562 5 g (before breakfast) and isoniazid 0.4 g (after dinner) for pulmonary tuberculosis. There were no abnormalities in her blood routine and liver function indexes before medication. Three days after the medication, the patient developed fatigue, nausea, and vomiting. The next-day laboratory tests showed white blood cell count 1.1×109/L, neutrophil count 0.32×109/L, hemoglobin (Hb) 120 g/L, platelet count (PLT) 149×109/L, alanine aminotransferase (ALT) 368 U/L, aspartate aminotransferase (AST) 1 333 U/L, total bilirubin (TBil) 19.7 μmol/L, and direct bilirubin (DBil) 6.6 μmol/L. Liver injury and neutropenia were diagnosed. Considering the reason from current medication, rifampicin and isoniazid were discontinued and liver-protective and symptomatic treatments were given. On day 4 of the withdrawal, the patient′s symptoms improved and laboratory tests showed neutrophil count 1.50×109/L, ALT 163 U/L, AST 139 U/L, TBil 9.0 μmol/L, and DBil 3.7 μmol/L. On day 7 of the withdrawal, the patient′s liver function improved (ALT 75 U/L, AST 33 U/L, TBil 6.4 μmol/L, and DBil 3.3 μmol/L) and her neutrophil count was 1.60×109/L. One week after discharge, the neutrophil count was 1.70×109/L; the levels of ALT, AST, TBil, and DBil were 30 U/L, 34 U/L, 10.0 μmol/L, and 4.2 μmol/L, respectively .
  • He Li′en, Bai Wanjun, Dong Zhanjun
    Adverse Drug Reactions Journal. 2018, 20(6): 478-479. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.06.027
    A 51-year-old female patient underwent resection of lymphatic cyst because of the infection of her pelvic lymphatic cyst after the cervical cancer operation. After the operation, the patient was given sequentially IV infusions of haemocoagulase agkistrodon for injection 2 units (dissolved in 0.9% sodium chloride injection), 10% potassium chloride injection 15 ml (added to 10% glucose injection 500 ml), and polygeline injection 500 ml. When about 100 ml of polygeline injection was infused, the patient suddenly lost consciousness, and her breath rate was 10 times/min, heart rate was 120 beats/min, blood pressure was 70/50 mmHg, and oxygen saturation was 0.70. Pulmonary embolism was considered and respiratory stimulants, hypertensors, and heparin were given, but the patient′s symptoms continued to worsen and her blood pressure dropped to 0. After 28 minutes of the rescue, allergic shock caused by polygelatin peptide injection was considered because of the flushing of the patient′s skin. The polygeline injection was stopped immediately, and then antianaphylaxis and antishock treatments were given. The patient′sblood pressure began to recover but remained unstable. Echocardiography showed more pericardial effusion than before the operation. Pericardiocentesis was urgently implemented, draining about 80 ml of effusion, and the drainage tube was indwelled. Antianaphylaxis and antishock treatments were continued. About 50 minutes later, the patient regained consciousness. And about 11 hours later, her blood pressure was 135/85 mmHg, breath rate was 18/min, heart rate was 100 beats/min, and oxygen saturation was 1.00.
  • Zhou Yuling, Yang Xinglong
    Adverse Drug Reactions Journal. 2019, 21(6): 465-466. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.020
    A 76-year-old male patient with Parkinson disease received long-term treatments with levodopa and benserazide hydrochloride tablets, carbidopa and levodopa controlled release tablets, and amantadine hydrochloride tablets. Due to the aggravation of the symptoms, oral piribedil sustained-release tablets 50 mg twice daily was added, whose dose was increased to thrice daily 1 month later. On day 3 of dose increase, the patient′s family member found that the patient developed unresponsiveness to verbal stimuli and the doctor found that the patient was in a state of sudden deep sleep. During the deep sleep attacks, his vital signs were normal and about 40 minutes later, the patient was awake. No abnormalities were found in cranial magnetic resonance imaging and electroencephalogram that same day. On day 10, the patient developed 2 times of deep sleep again, each time lasted for 30-40 minutes, and then relieved by himself. No abnormality was found in EEG. Sleep attacks caused by piribedil was considered. The dose of piribedil sustained-release tablets was gradually reduced and finally withdrawn. Sleep attacks did not recur.
  • Xiao Yayi, Lei Yi, Wang Xin, Bai Xiangrong, Zhang Qingxia, Fei Xiaolu
    Adverse Drug Reactions Journal. 2024, 26(3): 170-177. https://doi.org/10.3760/cma.j.cn114015-20230920-00691
    Objective To explore the application value of semantic information retrieval (semantic retrieval) based on case reports dataset of Adverse Drug Reactions Journal. Methods The dataset used in this study consists of 2-597 PDF files of case reports published on Adverse Drug Reactions Journal from 1999 to 2022. The semantic retrieval system is built by Baidu PaddlePaddle′s deep learning framework, the code was written in Python, and the text encoding model was Baidu RocketQA model. The precision at position k (P@k), recall at position k (R@k), mean reciprocal rank (MRR), mean average precision (MAP) and precision-recall (P-R) curve were used to evaluate the performance of semantic retrieval. The performance of semantic retrieval and keyword matching retrieval were compared by calculating the recall. Results The set of preprocessed theme fields as items to be retrieved contained 2-597 documents, the set of search terms (queries) after removing deplicates and reorganizing included 1-388 drug name queries and 1-118 adverse reactions/events queries. The precision of drug name queries and adverse reactions/events queries by semantic retrieval were 0.667-1 and 0.566-1, and their recall were 0.667-0.871 and 0.566-0.863, respectively. The P-R curves of the top 1, 3, 5 and 10 documents in the semantic retrieval results using drug names queries and adverse reactions/events search terms showed that the precision decreased slowly in top 1 and 3 documents but significantly in top 5 and 10 documents with the increase of recall. The MRR of the 2 types of search terms were 0.854 and 0.871, and the MAP were 0.778 and 0.773, respectively. Using adverse reactions/events as search terms, semantic retrieval has a higher recall rate than keyword matching retrieval; using drug names as search terms, the recall rate of keyword matching retrieval is generally higher than that of semantic retrieval. Conclusions The semantic retrieval system based on Baidu PaddlePaddle deep learning framework has good retrieval performance on the case reports dataset of Adverse Drug Reactions Journal. The semantic retrieval performs better with adverse reactions/events queries, while the keyword matching retrieval performs better with drug name queries.
  • Li Min, Yang Shiying, Zhang Liting
    Adverse Drug Reactions Journal. 2024, 26(12): 765-768. https://doi.org/10.3760/cma.j.cn114015-20240326-00190
    A 26-year-old female patient intermittently took 2% chloral hydrate solution (10 ml,thrice daily orally) by himself for 2 months due to sleep disorders. After 2 months of drug withdrawal, the patient developed persistent high fever (up to 40.0 ℃), generalized rash, mild yellow staining of skin and mucous membrane with itching, swollen lymph nodes, fatigue, and decreased appetite. Laboratory tests showed alanine aminotransferase 1 450 U/L, aspartate aminotransferase 465 U/L, total bilirubin 63.9 μmol/L, blood albumin 34.3 g/L, white blood cell count 16.2×109/L, eosinophils 0.029, platelet count 132×109/L, prothrombin activity 0.35, blood creatinine 67 μmol/L, triiodothyronine 0.7 nmol/L, and free triiodothyronine 22.18 pmol/L; heterotypic lymphocytes was found in peripheral blood smear. After 3 days of comprehensive treatments including liver protection, jaundice reduction, supplementation of coagulation factors, maintenance of water and electrolyte balance, energy support and anti-infection, the patient still had persistent high fever, his blood albumin decreased to 26.2 g/L, platelets decreased to 26×109/L, total bilirubin increased to 225.0 μmol/L, blood creatinine increased to 240 μmol/L, and eosinophils increased to 0.17. Abdominal ultrasound and cardiac color Doppler ultrasound showed progressive enlargement of the spleen, with effusion in thoracic, abdominal, and pericardial cavities. Drug reaction with eosinophilia and systemic symptoms induced by chloral hydrate was diagnosed. Antibiotic was stopped and intravenous infusion of methylpred- nisolone 40 mg once daily was given. Three days later, the patient′s body temperature returned to normal, various indicators were gradually improved, and the rash gradually disappeared. One month later, the glucocorticoids gradually decreased until the medication was stopped, and the rash did not recur. At a 2-year follow up, the patient′s liver and kidney function, blood routine, thyroid function, etc. were all normal.
  • Qu Fenfen, Wu Xinjing, Hu Yongmei
    Adverse Drug Reactions Journal. 2024, 26(12): 756-758. https://doi.org/10.3760/cma.j.cn114015-20240118-00042
    A 53-year-old female patient with stage Ⅳa colon cancer received 7 cycles of standard chemotherapy regimen. Due to the progression of the condition, she was treated with fruquintinib (5 mg once daily orally on day 1-21, 28 days as one cycle). After 20 days of treatments, the patient experienced sudden consciousness disorders, accompanied by limb convulsions. Her blood pressure was 200/150 mmHg, with urinary protein (+++). Enhanced MRI showed multiple cortical and subcortical abnormal signals in the bilateral frontal, temporal, parietal, and occipital lobes. Reversible posterior leukoencephalopathy syndrome caused by fruquintinib was considered. Then the drug was discontinued. After 2 days of symptomatic treat- ments such as oxygen therapy, blood pressure reduction, sedation, and antiepileptic therapy, the patient′s consciousness was improved, no limb convulsions occurred and her blood pressure was 130/80 mmHg. After 8 days of treatments, the patient′s condition stabilized and fruquintinib was given again after reducing the dosage. At an one month follow-up, MRI enhancement showed no significant abnormalities.
  • Xu Chao, Yue Lixia, Hao Jichun, Ma Dong, Wang Lei
    Adverse Drug Reactions Journal. 2023, 25(2): 101-106. https://doi.org/10.3760/cma.j.cn114015-20220408-00297
    Objective To understand the efficacy and safety of bivalirudin for perioperative use in elderly patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). Methods Clinical data of elderly patients with STEMI who were anticoagulated with bivalirudin (observation group) and the same number of consecutive cases who were anticoagulated with heparin (control group) during the perioperative period of PCI in Cangzhou Central Hospital from May 2018 to June 2020 were collected according to the catheterization room record. The information included patients′ demographic information, previous disease history, preoperative examination and intraoperative findings, thrombolysis in myocardial infarction (TIMI) flow grade before and after operation, as well as all-cause death, major adverse cardiac and cerebrovascular event (MACCE), bleeding events, and stent thrombosis events within 30 days after operation. The improvement of TIMI blood flow grade after PCI and the incidence of all-cause death, MACCE, bleeding events, and stent thrombosis within 30 days after PCI were compared between the 2 groups. Results A total of 85 patients who were treated with bivalirudin during PCI were entered in the observation group, including 51 males and 34 females, and 85 patients who were treated with heparin during PCI were entered in the control group in the same period, including 50 males and 35 females. The differences in age, gender, previous history of cardiovascular-related diseases, smoking history, heart rate before PCI, estimated glomerular filtration rate, left ventricular ejection fraction, Killip grading, TIMI blood flow grading before the PCI, infarct-related artery, use of intra-aortic balloon pump during operation, PCI procedure route, vascular lesions, and stent implantation between the 2 groups were not statistically significant (all P>0.05). The TIMI blood flow grade in the observation group and the control group after PCI treatment was significantly improved compared with that before treatment, and the difference was statistically significant (all P<0.001). But the difference in TIMI blood flow grade after treatment between the 2 groups was not statistically significant (P=0.278). The incidence of MACCE within 30 days after PCI in the observation group was lower than that in the control group (P=0.026), but the differences in all-cause death, cardiogenic death, myocardial infarction, stroke, and target vessel revascularization events, and stent thrombosis within 30 days after PCI were not statistically significant (all P>0.05). Conclusions The efficacy of anticoagulation with bivalirudin during PCI in elderly patients with STEMI is similar to that of heparin. Compared with heparin, bivalirudin can reduce the overall incidence of MACCE within 30 days after PCI, and does not increase the occurrence risk of stent thrombosis.
  • Qin Yinpeng, Wang Chao, Zhang Ruixia, Guo Yuanyuan, Qian Yude, Zhang Yi
    Adverse Drug Reactions Journal. 2024, 26(6): 347-354. https://doi.org/10.3760/cma.j.cn114015-20240129-00070
    Objective To evaluate the efficacy, safety, and economics of ertapenem in the treatment of infectious diseases by means of rapid health technology assessment. Methods The relevant databases and health technology assessment websites (up to July 31, 2023) were searched to collect the meta- analyses and economic literature on the efficacy, safety, and economics of ertapenem and other antibacterial drugs in the treatment of infectious diseases. The quality of meta-analyses and economic researches were evaluated by a measurement tool to assess systematic reviews and consolidated health economic evaluation reporting standards, respectively. The patients were divided into ertapenem group and control group (using other antibacterial drugs). The outcome indicators of meta-analysis (clinical cure rate, bacterial clearance rate) and the incidence of adverse reactions were compared between the 2 groups. The economic research were cost-effectiveness analysis and cost-consequence analysis. The relevant results were described qualitatively. Results A total of 13 literature were enrolled, including 7 systematic reviews/meta-analyses (4 of high-quality, 3 of medium quality) and 6 pharmacoeconomics literature (4 of high quality, 2 of medium quality). There were no significant differences on the clinical cure rate and bacterial clearance rate for complex abdominal infection, community-acquired pneumonia, complex skin and appendage infection between the ertapenem group and the control group (all P>0.05). The clinical cure rate of severe diabetic foot infection in the ertapenem group was lower than that in the piperacillin sodium and tazobactam sodium group [91.5% (119/130) vs. 97.2% (139/143), P=0.04]. The bacterial clearance rate of complicated urinary tract infection in the ertapenem group was higher than that in the ceftriaxone group [98.71% (305/309) vs. 95.45% (273/286), P=0.03]. The incidence of adverse reactions (elevated transaminase and alkaline phosphatase or elevated platelet count) in patients with complex abdominal infection in the ertapenem group was higher than that in the control group [8.96% (68/759) vs. 6.49 %(50/771), P<0.05]. The incidence of adverse reactions after ertapenem treatment for complex infections (community-acquired pneumonia, complicated urinary tract infection and complex abdominal infection) was higher than that in ceftriaxone treatment with or without metronidazole group [10.62% (163/1-535) vs. 7.89% (91/1-153), P=0.02]. The incidence of diarrhea in patients with diabetic foot infection in the ertapenem group was lower than that in the piperacillin sodium and tazobactam sodium group [8.14% (24/295) vs. 14.09% (41/291), P=0.02]. It was more cost- effective using ertapenem than using piperacillin sodium and tazobactam sodium, ceftriaxone in treatment of complex abdominal infection, diabetic foot infection, complicated urinary tract infection, community-acquired pneumonia, etc. Conclusions The efficacy of ertapenem in treatment for complex abdominal infection, community- acquired pneumonia and complex skin and appendage infection are similar to that of commonly used anti- biotics in clinic, and the bacterial clearance rate in treatment for complicated urinary tract infection was higher than that of ceftriaxone. There are differences in the incidence of adverse reactions in complex abdominal infection, community-acquired pneumonia, complicated urinary tract infection, and diabetic foot infection between the 2 groups. The use of ertapenem can reduce the cost of drug treatment and has economic advantages.
  • Adverse Drug Reactions Journal. 0, (): 382-382. https://doi.org/10.3760/cma.j.cn114015-20230614-00432
  • Adverse Drug Reactions Journal. 2023, 25(6): 382-382. https://doi.org/10.3760/cma.j.cn114015-20230614-00432-1
  • Wang Daimei, Zhao Eryi, Zhong Jingbo, Han Fangxuan, Lyu Xiuping
    Adverse Drug Reactions Journal. 2019, 21(4): 311-312. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.04.020
    A 22-year-old female patient received methylprednisolone sodium succinate (methyl-prednisolone) for injection(1 000 mg/d for 3 days and gradually reduced to 60 mg/d for maintenance therapy, IV infusion), immunoglobulin (20 g/d, IV infusion), mouse nerve growth factor (20 μg/d, intramuscular injection), vitamin B1 (100 mg/d, intramuscular injection), and mecobalamin(1 mg/d, IV injection) for multiple sclerosis. Twelve days later, mouse nerve growth factor was temporarily discontinued and 7 days later, the drug was given again. On day 2 of retreatment, the patient developed conjunctival congestion. On day 3 of retreatment, red spots appeared on her chest, back, abdomen, and forearms. Then the rashes gradually increased, linked into pieces, and spread all over the body. Rashes partly formed blisters, blisters ulcerated, and epidermis exfoliated. It was considered that mouse nerve growth factor induced the toxic epidermal necrolysis. Then the drug was discontinued, the dose of methylprednisolone was increased to 500 mg/d, and at the same time, immunoglobulin, desloratadine, and fexofenadine were given. Twenty days later, the rashes subsided and pigmentation remained.
  • Zhang Zhicui, Wu Shihua, Zhen Ji
    Adverse Drug Reactions Journal. 2019, 21(5): 360-365. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.009
    ObjectiveTo explore the efficacy and safety of dezocine after laparoscopic cholecys-tectomy at a high altitude area (average altitude of over 4 500 m).MethodsThe study was designed as an open randomized controlled study. The subjects were selected from patients who underwent laparoscopic cholecystectomy and required postoperative analgesia in Duilongdeqing District People′s Hospital of Lhasa. The patients were randomly divided into the observation group and the control group. They had the same anesthesia method during operation and patient-controlled intravenous analgesia (PCIA) was initiated after the operation. The patients in the observation group were treated with dezocine 0.6 mg/kg plus ondansetron 16 mg diluted in 0.9% sodium chloride injection 100 ml for PCIA, while in the control group, dezocine was replaced by sufentanil 2 μg/kg. According to the difference in the incidence of excessive sedation between dezocine and sufentanil in previous literature, it was estimated that the sample size in the 2 groups should be >14 cases and the patients should be terminated when the test efficacy was >0.8. Visual analogue scale (VAS) score (pain evaluation) and Ramsay sedation scale (sedation evaluation) at 1, 4, 8, 12, 24 and 48 hours, frequency of PCIA pump pressing and dosage of anesthetics, and the incidence of adverse events related to analgesics within 48 hours after operation in patients in the 2 groups were compared.ResultsFrom January 2015 to November 2017, a total of 50 patients were enrolled in the study, including 25 in the observation group and 25 in the control group. The differences in gender, age, weight, American Society of Anesthesiologists classification, operation time, frequency of PCIA pump pressing and dosage of anesthetics between the 2 groups  were not significant (P>0.05 for all). The differences in VAS scores at all time points after operation were not significant (P>0.05 for all). The Ramsay sedation scores in patients in the observation group at 1 and 4 hours after operation were significantly lower than those in the control group [(2.5±1.1) score vs. (3.4±1.4) score, P=0.016; (2.5±1.0) score vs. (3.5±1.5) score, P=0.007]. The incidences of sedation-related adverse events such as nausea, vomiting, respiratory depression within 48 hours after operation in the control group were significantly lower than those in the control group[8.0% (2/25) vs. 36.0% (9/25), 0 vs. 24.0% (6/25), 4.0% (1/25) vs. 44.0% (11/25), P<0.05 for all].ConclusionsThe analgesic effect of dezocine after laparoscopic cholecystectomy at high altitudes was similar to that of sufentanil and the incidences of respiratory depression and excessive sedation were lower than those of sufentanil. Dezocine may be safer for patients at high altitudes.
  • Qu Jingrong, Zhang Lei
    Adverse Drug Reactions Journal. 2024, 26(9): 571-573. https://doi.org/10.3760/cma.j.cn114015-20231222-00926
    A 15-year-old female child with juvenile idiopathic arthritis for 10 years received methotrexate combined with adalimumab (80?mg by subcutaneous injection once every 2 weeks) 2 years ago. After 1.5 years of treatments, red papules appeared on the skin of the perineum and thigh, accompanied by itching.The rash gradually spread to multiple parts of the body, including the head,neck, and limbs, with plaques and scales, and the rash on both calve ruptures and oozes, accompanied by itching and pain. It was considered to be severe atopic dermatitis caused by adalimumab based on skin pathological results, elevated serum immunoglobulin E, and clinical signs. The results of the patient′s wound secretion culture indicated a mixed infection of resistant bacteria such as Staphylococcus aureus, Pseudomonas aeruginosa, and Enterococcus faecalis. After discontinuing adalimumab and receiving systemic treatments with anti?allergic and sensitive antibiotics, as well as local treatment with glucocorticoids for 14 days, the rash and infection were improved. At the six?month of follow-up, the patient′s skin lesions were basically healed.
  • Li Yunsong, Lin Min, Chen Quanyao, Wang Lingsong, Chen Yao
    Adverse Drug Reactions Journal. 2019, 21(5): 339-345. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.05.006
    ObjectiveTo understand the occurrence and main characteristics of medication errors (ME) in Xiamen Maternal and Child Health Hospital.MethodsAll the ME reports received by the ME submission system of Xiamen Maternal and Child Health Hospital from January 1, 2015 to December 31, 2017 were collected, and ME characteristics such as the time of occurrence, classification, grade, drugs involved, and triggering factors were analyzed. On the basis of the 9-level grading method (grade A-I), ME were further divided into potential errors (including potential error problems and errors that happened but the drugs were not given to patients) and out-door errors (the wrong drugs had been given to patients).ResultsA total of 18 944 ME reports were collected, including 12 ME that occurred before the link of prescription and did not involve patients and 18 932 ME that occurred in the link of prescription and various links after the prescription. Of the 18 932 ME, 231 were out-door errors, which accounted for 1.22% of overall ME. A total of 3 553 074 patients (number of registrations)were prescribed in the study period in the hospital and the incidences of overall ME and out-door errors were 0.53% (18 932/3 553 074) and 0.07‰ (231/3 553 074), respectively. The highest incidences of both the potential errors and out-door errors appeared from 13: 00 to 13: 59 [21.87‰(1 120/51 248);0.18‰(9/51 248)]. The top 3 ME classes in the 18 944 ME were prescription errors (77.37%, 14 657 ME), dispensing and location errors (17.35%, 3 286 ME), and omission and delivering errors (2.22%, 421 ME). Of the 18 944 ME,6 (0.03%), 18 821 (99.35%), 111 (0.59%), and 6 (0.03%) ME were grading as A, B, C, and D, respectively, while none was grading as E-I. Personnel factor took the first place [59.65% (11 301/18 944)] in all the triggering factors of ME, followed by environmental factor [17.71% (3 355/18 944)].ConclusionsThe incidence of overall ME in Xiamen Maternal and Child Health Hospital was 0.53% and most of the ME were not serious, which were no harm to patients. The peak time of the ME occurrence lasted from 13: 00 to 13: 59. Prescription error was the main type of ME and the main trigger factor was personnel factor . Results of the study could help to develop targeted precautions to reduce the occurrence of ME.
  • Su Feiyue, Ge Xueya, Jiang Li, Luo Di, Bai Ruonan, Yang Jiner, Wang Weihong, Xiao Mingzhao
    Adverse Drug Reactions Journal. 2024, 26(10): 601-607. https://doi.org/10.3760/cma.j.cn114015-20240122-00053
    Objective To systematically evaluate the relationship between thiazide diuretics and the risk of hip fracture in the elderly patients. Methods The relevant databases at home and abroad were searched up to December 31, 2023 and case-control studies and cohort studies on the relationship between thiazide diuretics and the risk of hip fractures in the elderly patients were collected. Quality of the enrolled studies was evaluated by bias risk assessment tool of Newcastle-Ottawa Scale (NOS). RevMan 5.4 software was used for meta-analysis on related outcome indicators, and the effect sizes were odds ratio (OR) and the 95% confidence interval (CI). Funnel plots, Egger′s method and Begg′s method were performed using Stata 15.1 software to analyze the inclusion literature for publication bias. Results A total of 18 studies were enrolled in the study, including 7 case-control studies and 11 cohort studies and involving 175 200 patients in the trial group (thiazide diuretics) and 1 574 989 in the control group (placebo or other medications). All 18 studies scored ≥5 on the NOS (15 articles of high quality and 3 articles of medium quality). The meta-analysis results indicated that the risk of hip fractures in the trial group was lower than that in the control group (OR=0.82, 95%CI: 0.75-0.89, P<0.001). Subgroup analyses by study type and gender both revealed that thiazide diuretics were associated with a reduced risk of hip fractures in the elderly (adjusted OR in case-control studies was 0.78, 95%CI: 0.72-0.84, P<0.001; adjusted OR in cohort studies was 0.83, 95%CI: 0.74-0.93, P=0.002; adjusted OR in female was 0.78, 95%CI: 0.72-0.85, P<0.001; adjusted OR in male was 0.73, 95%CI: 0.68-0.80, P<0.001). The subgroup analysis of 11 large-sample studies (≥2 000 cases) indicated that thiazide diuretics were associated with a reduced risk of hip fractures in the elderly (adjusted OR=0.79, 95%CI: 0.72-0.87, P<0.001). However, 6 small-sample studies did not find the similar correlation. A combined analysis of studies that rigorously controlled for confounding factors revealed that thiazide diuretics were associated with a lower risk of hip fractures in the elderly (OR=0.79, 95%CI: 0.74-0.84, P<0.001), and the combined results showed no heterogeneity (P=0.72, I2=0%). Conclusions Thiazide diuretics were associated with a reduced risk of hip fractures in the elderly patients. Based on a comprehensive assessment of the risks and benefits of medication for elderly patients, clinicians may prioritize thiazide diuretics as a component of combination therapy for eligible patients, which may be beneficial in reducing their risk of hip fractures.
  • Zhang Wei, Fu Jingwen, Wang Yonghui, He Tao, Lu Zhihong
    Adverse Drug Reactions Journal. 2023, 25(6): 327-331. https://doi.org/10.3760/cma.j.cn114015-20220905-00809
    Objective To explore the effect and its mechanism of nalbuphine on pruritus/paresthesia induced by fospropofol disodium under general anesthesia. Methods The study was designed as a prospective, single-center, randomized, double-blind controlled trial. Patients scheduled for surgery under general anesthesia in Xijing Hospital, Air Force Medical University from April to May 2022 were entered and randomly divided into nalbuphine group and control group using the random sequence table method. Patients of both groups were given general anesthesia with fospropofol disodium. Thirty minutes before the end of the surgery, patients in the nalbuphine group received intravenous injection of nalbuphine 0.2-mg/kg (0.1-ml/kg), while those in the control group received intravenous injection of an equal volume of 0.9% sodium chloride injection. Venous blood samples of patients in the 2 groups were collected 5-minutes before anesthesia induction and 5-minutes after awakening to detect levels of serum interleukin 6 (IL-6), tumor necrosis factor α (TNF-α), and S-100 calcium binding protein β (S-100β). The primary indicator of the study was the incidence of pruritus/paresthesia within 30-minutes after extubation; the secondary indicators included time to eye opening upon calling, the maximum pruritus/paresthesia score within 30-minutes after extubation, nausea/ vomiting score, pain score, the incidence of pruritus/paresthesia within 24-hours after operation, the score of patient satisfaction to anesthesia, and the levels of postoperative serum inflammatory markers. Results A total of 98 patients enrolled the study, 49 in each group. There were no statistically significant differences in gender, age, body mass index, American Society of Anesthesiologists grade, operation type, operation time, or anesthesia time of patients between the 2 groups (all P>0.05). The incidence of pruritus/paresthesia and the score of pruritus/paresthesia 30-minutes after extubation were lower in the nalbuphine group than those in the control group, with statistically significant differences [24.5% (12/49) vs. 61.2% (30/49), P<0.001; 4 (2, 5) vs. 6 (5, 7), P=0.031]. At 24-hours of postoperation, the score of patient satisfaction to anesthesia in the nalbuphine group was higher than that in the control group, with a statistically significant difference [8 (7, 9) vs. 6 (3, 7), P=0.042]. Compared with the control group, the postoperative serum IL-6 in patients of the nalbuphine group was significantly lower [(329.5±105.5) ng/L vs. (398.5±102.6) ng/L, P=0.033], while differences in levels of TNF-α and S-100 β were not statistically significant (all P>0.05). Conclusion Nalbuphine can significantly reduce the incidence of pruritus/paresthesia induced by fospropofol disodium under general anesthesia and improve the patient satisfaction to anesthesia, and its mechanism may involve the inhibition of inflammatory response by nalbuphine.
  • Wang Li, Zhang Xusheng, Ren Xiuli, Shen Chengwu, Lu Cuicui
    Adverse Drug Reactions Journal. 2025, 27(3): 182-187. https://doi.org/10.3760/cma.j.cn114015- 20240508- 00315
    Glucagon- like peptide- 1 receptor agonists (GLP- 1RA) have been widely used in the treatment of type 2 diabetes mellitus (T2DM). However, the acceleration of heart rate caused by GLP- 1RA should not be ignored. In the general population and patients with diabetes, increased heart rate has an independent correlation with the incidence and mortality of cardiovascular diseases. In general, the long- acting GLP- 1RA seem to exert a greater effect in increasing heart rate, and the effect is dose- dependent and negatively correlated with baseline heart rate. The increase in heart rate caused by GLP- 1RA may be related to enhanced sympathetic nervous activity, reflex tachycardia as a response to vasodilation, etc. It is advisable to closely monitor the increased heart rate induced by GLP- 1RA in clinical practice, especially in patients with high- risk factors for cardiovascular disease. In case of elevated heart rate, the management begins with immediate discontinuation of the GLP- 1RA and symptomatic intervention should be given if necessary.
  • Wang Quan, Zhao Junwu, Fang Wei, Li Jinfeng
    Adverse Drug Reactions Journal. 2025, 27(5): 315-317. https://doi.org/10.3760/cma.j.cn114015-20240130-00071
    A 61-year-old female patient was treated with sintilimab (200 mg by intravenous infusion on the first day, 21 days as a cycle) for lung adenocarcinoma and multiple lymph node metastases in the left hilum and mediastinum (10 cycles in total). Headache and dizziness in the patient occurred about 1 month after the last medication. Cerebrospinal fluid examination showed white blood cell count 14×106/L, total protein 799.8 mg/L, Pandy′s test (+), immunoglobulin G 70.8 mg/L, and glucose and chloride within the reference value range. The antibodies against N-methyl-D-aspartate receptor in cerebrospinal fluid and serum were all positive. The patient was diagnosed as having sintilimab-induced autoimmune encephalitis. After receiving methylprednisolone sodium succinate by intravenous infusion for 7 days, the patient′s headache and dizziness were alleviated. After that, the methylprednisolone sodium succinate was switched to oral prednisone acetate tablets. At a 2 month follow-up, no symptoms of headache or dizziness recurred in the patient.
  • Yao Hairong, Liu Shikai
    Adverse Drug Reactions Journal. 2023, 25(11): 702-704. https://doi.org/10.3760/cma.j.cn114015-20221103-01023
    A 58-year-old female patient underwent ovarian cancer tumor cell reduction surgery for advanced ovarian serous carcinoma in stage ⅣB for more than 3 years and received chemotherapy with paclitaxel and carboplatin regimen for a total of 6 cycles and chemotherapy with doxorubicin liposome and carboplatin regimen for a total of 6 cycles successively. After that, olaparib 300-mg was administered twice daily orally for maintenance treatment. Twenty-five days later, due to the occurrence of grade Ⅱ bone marrow suppression in the patient, the dose of olaparib was reduced to 150-mg in the morning and 300-mg in the evening. After 13 months of olaparib treatment, the patient developed pancytopenia, with the lowest platelet count of 2×109/L. Olaparib was stopped immediately.The symptomatic and supportive treatments such as infusion of suspended red blood cells and fresh platelets, elevation of white blood cells,iron replenishment, and platelet elevation were given, but the efficacy was not obvious. Bone marrow flow cytometry detection suggested a high possibility of myelodysplastic syndrome. After discontinuing olaparib for 47 days, the patient died of circulatory failure due to massive abdominal and pelvic bleeding and hemorrhagic shock.
  • Wang Tingting, Jiang Li, Wang Meiping
    Adverse Drug Reactions Journal. 2024, 26(2): 76-81. https://doi.org/10.3760/cma.j.cn114015-20231108-00788
    Objective To understand the current status of regional citrate anticoagulation (RCA) application in patients of Intensive Care Units (ICUs) and physicians′ thoughts on RCA. Methods This study was designed as a status quo survey. Researchers independently designed a questionnaire (3 parts, 20 questions in total) and gathered data from 3 aspects, including general information of respondents, their thoughts of RCA, and the specific processes of RCA implementation in their ICUs. The survey was conducted online, and clinicians in ICUs across the country voluntarily participated from April 15 to April 30, 2022. Descriptive statistical analysis was performed to analyze the collected data. Results A total of 630 electronic questionnaires were collected, of which 616 were confirmed as valid (an effective rate of 97.8%). These 616 physicians came from 587 ICUs in 21 provinces, 4 municipalities, 4 autonomous regions, and 1 special administrative region across the country. Among them, 530 were from hospitals of 3A-level, and 302-held senior professional titles. RCA was implemented in 488 (83.1%, 488/587) ICUs (involving 503 physicians), and no significant correlation was found between the type of ICU (general, internal medicine, surgical, or specialized) and whether RCA was conducted or not. The main reasons for RCA implementation in ICUs included having lower risk of bleeding (96.4%, 485/503), convenient monitoring (62.2%, 313/503) ,and guideline recommendations (62.0%,312/503). RCA was not implemented in 99 (16.9%,99/587) ICUs (involving 113 physicians), and the main reasons for not carrying out RCA were the absence of citrate sodium in hospitals (58.4%, 66/113), followed by lack of experience or protocols and higher cost (each 14.2%, 16/113). Among the 503 physicians in ICUs implementing RCA, 443 physicians (88.1%) believed that severe liver dysfunction (Child grade B and above) was a contraindication for RCA; 388 physicians (77.1%) and 377 physicians (75.0%) recognized metabolic alkalosis and hypocalcemia as complications of RCA, respectively; 273 physicians regularly monitored the total calcium/ionized calcium ratio daily; 276 physicians (54.9%) and 181 physicians (36.1%) set the blood flow rate at 120-150-ml per minute and 151-180-ml per minute, respectively; 377 physicians (74.9%) chose prepackaged replacement fluids, with pre-dilution+post-dilution as the dilution method (252 physicians, 50.1%); 239 physicians (47.6%) added sodium bicarbonate injection via a separate intravenous route; 400 physicians (79.5%) used a citrate sodium dosage plan of 1.2-1.5 times the blood flow rate per minute per hour. Conclusions Currently, RCA is widely implemented in comprehensive ICUs in China, and relevant clinical physicians have certain knowledge of its contraindications and potential complications. However, different hospitals use varied protocols in implementing RCA, and a unified standard of monitoring method have not yet formed.
  • Adverse Drug Reactions Journal. 2024, 26(4): 197-197. https://doi.org/10.1002/pds.5735.
    用药错误(medication error, ME)可能对患者安全造成不良严重后果。该研究的作者尝试使用Evans 提出的假设生成技术―比例失衡分析(disproportionality analysis, DPA)方法评估2014年至2018年向丹麦患者安全数据库(Danish Patient Safety Database, DPSD)报告的MEs。
    作者使用比例报告比值(proportional reporting ratio,PRR)法来识别比例失衡的信号。以PRR的95%置信区间下限大于1.00,并且超额报告数(excess number, ER)大于10作为筛选信号的阈值。超额的数量是基于“观察到的”和“预期的”报告数量之间的差值。
    作者的分析表明,抗凝血剂、阿片类药物、胰岛素、抗癫痫药物和抗精神病药物在特定的ME中表现出最高的信号;华法林和达特帕林与药物使用过程中的“处方阶段”以及“剂量不足”的错误类型相关;芬太尼和吗啡与“处方阶段”和“给药次数或数量错误”的错误类型相关;几种类型的胰岛素与“药物错误”的错误类型有关;而抗癫痫药物如拉莫三嗪、奥卡西平和丙戊酸,以及抗精神病药物如喹硫平,与“执行医嘱阶段”的“未服用药物”的错误类型有关。作者还发现了以前未被注意到的药物,如氯普噻吨,与“错误配药”有关,匹美西林与“遗漏给药”有关,左旋甲状腺素与“数量错误或缺失”有关。
    一些高风险药物在该研究中没有产生信号,提示作者可能需要适当调整信号阈值。作者的研究结果表明,尽管DPA方法对选择性的低报敏感,某些没有报告或报告不完整的数据可能对结果产生较大影响,但DPA可以作为基于药物安全报告系统筛选MEs和确定进一步研究的优先领域的附加工具。这种方法可以帮助优化资源并改善患者安全。
  • Chen Zijia, Chen Zhiqing, Peng Wenxi, Wang Zhifei, Xie Yanming
    Adverse Drug Reactions Journal. 2025, 27(5): 281-287. https://doi.org/10.3760/cma.j.cn114015-20240614-00444
    Objective To evaluate the clinical safety of Fufang E‘jiao syrup and provide reference for its rational and safe clinical use. Methods The literature involving Fufang E'jiao syrup in domestic and international databases, as well as the relevant clinical trials on ClinicalTrials.gov and the Chinese Clinical Trial Registry website were searched up to June 1, 2024. Those literature and clinical trials reporting drug adverse events were included, and the basic information about literature/clinical trials (title, publication year, study design, etc.), patients (age, gender, primary diseases, and dosage of Fufang E'jiao syrup), and adverse events (time of occurrence, clinical manifestations, and outcomes) was extracted. The adverse events were standardized and classified using the Medical Dictionary for Regulatory Activities version 25.0, and were also analyzed based on traditional Chinese medicine theory. Results A total of 19 literature were included in the analysis, including 16 observational/experimental clinical studies, and 3 case reports. The 19 literature reported a total of 430 adverse events involving 398 patients, and the patients were mainly with malignant tumors and anemia. The 430 adverse events involved 11 system organ classes, which mainly included gastrointestinal disorders (260 events, 60.47%, with the most common symptom being dry mouth), respiratory, thoracic, and mediastinal disorders (119 events, 27.67%, with the most common symptom being dry throat), and skin and subcutaneous tissue disorders (16 events, 3.72%, with the most common symptom being mucosal ulcers). Based on traditional Chinese medicine theory, the 430 adverse events were mainly manifested as symptoms of indigestion (nausea, epigastric discomfort, and decreased appetite) and symptoms of “heat” (dry mouth and dry throat). Conclusions Fufang E'jiao syrup has a relatively good overall safety profile, with the most common adverse events being symptoms of “heat” and gastrointestinal reactions. Patients should not use it blindly, and it should be used with syndrome differentiation in clinical practice.
  • 病例报告
    Pang Wenli;Jiang Lili;Zhang Dexian
    . 2008, 10(1): 0-0.

    A 60yearold woman with diabetes was instilled with compound tropicamide eye drops for mydriasis before examination of ocular fundus. She developed a markedly decreased auditory acuity with tinnitus. An examination showed a bilateral sensorineural deafness. After treatment with hyperbaric oxygen and puerarin, her hearing recovered obviously. The patient was instilled with the eye drops again for examination of eye, and then her markedly decreased auditory acuity recurred. Deafness occurred after the fourth instillation of tropicamide eye drops. Despite more than 1 month's treatment, her hearing did not recover.

  • Qiu Yanlong, Huang Min, Li Xiudong, Liu Jinyan
    Adverse Drug Reactions Journal. 2025, 27(5): 313-315. https://doi.org/10.3760/cma.j.cn114015-20240918-00049
     A 66-year-old female patient self-administered Jingyaokang capsules (a compound preparation of traditional Chinese medicines, 3 capsules thrice daily orally) due to lumbar pain. The patient developed oliguria and edema of bilateral lower limbs after 3 doses of medication on the same day. The laboratory tests showed WBC 7.3×109/L, neutrophil percentage 0.70, blood urea 12.7 mmol/L, blood crea- tinine 179 μmol/L, and blood uric acid 461 μmol/L. The kidney function tests 15 days ago showed no abnormalities in the patient. Acute kidney injury caused by Jingyaokang capsules was considered. The drug was stopped and symptomatic treatments including torasemide and maintenance of fluid balance were given. The patient′s urine output gradually increased. Five days later, the patient′s edema of bilateral lower limbs disappeared, and her blood urea and creatinine decreased to normal range. The acute kidney injury in the patient may be related to strychni semen component in the Jingyaokang capsules.
  • Fan Liyuan, Li Mengge, He Yifu, Xing Yufei, Yang Ying, Ding Conglan
    Adverse Drug Reactions Journal. 2024, 26(4): 217-222. https://doi.org/10.3760/cma.j.cn114015-20230911-00667
    Objective To improve the skin toxicity management model of tumor targeted drugs based on evidence-based practice method and apply it to clinical practice. Methods Using the evidence- based practice method of Joanna Briggs Institute, evidence of skin toxicity management of tumor targeted drugs was formed by searching relevant guidelines and evidence-based medical literature at home and abroad, and conducting interviews and surveys with nurses and patients. Based on the evidence and in consultation with evidence-based medicine, nursing and clinical experts, the evidence was transformed into management improvement plans, and the skin toxicity checklist and care checklist were developed. The improvement scheme was applied to clinical practice, the training of nurses was strengthened, the nursing process was standardized and improved, and various forms of health education were provided to patients. Patients with skin toxicity who received targeted drug therapy in the Department of Oncology of Anhui Cancer Hospital from May to August 2023 were collected. Implementation of various management indicators by nurses before and after management improvement were compared. The occurrence and severity of skin toxicity in patients were compared to verify the effect of the improvement. Results A total of 35 tumor patients with skin toxicity to targeted drugs were entered, including 26 males and 9 females, with age (60±10) years. Compared with before, the implementation rate of the 5 indicators after the management improvement, including the evaluation of skin toxicity and risk factors by nurses using the common terminology criteria for adverse events version 5.0, the qualified status of related nursing documents, the health education of skin care, and regular follow-up of patients, were significantly increased (from 0-31.4% up to 80%-100%), the differences were statistically significant (all P<0.05). After improvement, the incidence and severity of skin rash, skin dryness, skin reaction of hands and feet, and paronychia were significantly reduced, the score of skin care knowledge questionnaire was significantly increased [6.00(5.00, 8.00) vs. 8.00(7.00, 9.00), P=0.002], and the dermatology life quality index was significantly decreased [8.00(6.00, 9.00) vs. 6.00(5.00,8.00), P=0.033]. The differences in anxiety and depression scores were not statistically significant (both P>0.05). Conclusion The skin toxicity management of targeted drugs based on JBI evidence-based practice method can standardize the clinical nursing practice of nurses, improve the severity of skin toxicity in tumor patients, and improve their quality of life.
  • Cui Shijun, Guo Jianming, Tong Zhu, Guo Lianrui, Gu Yongquan
    Adverse Drug Reactions Journal. 2024, 26(4): 193-197. https://doi.org/10.3760/cma.j.cn114015-20230918-00686
    Objective To explore the long-term efficacy and safety of gene therapy with pUDK- hepatocyte growth factor (pUDK-HGF) for rest pain and ulcers caused by critical limb ischemia. Methods Long-term follow-up were conducted through outpatient and telephone on patients who completed the pUDK-HGF Phase Ⅱ randomized double-blind placebo-controlled trial. The occurrence of tumors was observed, and tumor markers detection, fundus examination, visual analogue scale (VAS), and lower limb CT angiography (CTA) were performed according to voluntary principle. The results were analyzed descri- ptively and statistically. Results A total of 53 patients were included in the analysis, of which 15 (28.3%) were in the placebo group and 38 (71.7%) were in the pUDK-HGF treatment group in the Phase Ⅱ clinical trial. The median follow-up time was 2.8 years, ranging from 1.7 to 3.5 years. During the follow-up period, no tumor was found in the 53 patients. Among the 38 patients in the pUDK-HGF treatment group, 18 underwent comprehensive examination and evaluation, including tumor markers, fundus and CTA examination, and patients with resting pain underwent VAS evaluation. Among them, 1 patient had transient mild elevation of carcinoembryonic antigen, and no abnormal tumor markers were found in the other 17 patients; no proliferative retinal vasculopathy was found in the fundus examination. At the end of the phase Ⅱ clinical trial (out-group), 3 were effective and 2 were ineffective of the 5 patients with rest pain; at the end of this follow-up period, 4 were evaluated as effectiveness and 1 as ineffectiveness according to CTA, and 5 were all evaluated as effectiveness according to VAS. Of the 13 patients with ulcer, 9 were evaluated as effectiveness and 4 were as ineffectiveness according to CTA at out-group; 10 were evaluated as effectiveness and 3 were as ineffectiveness at the end of this follow-up. Conclusions pUDK-HGF had relatively good safety in the treatment of rest pain and ulcers caused by critical limb ischemia. No risk of carcinogenesis and proliferative retinal vasculopathy has been found, and the long-term efficacy of pUDK-HGF is good.
  • Wang Yu, Ma Li, Luan Bo
    Adverse Drug Reactions Journal. 2023, 25(6): 339-344. https://doi.org/10.3760/cma.j.cn114015-20220726-00676
    Objective To explore the optimal dosage of dexmedetomidine for pediatric abdominal surgery under general anesthesia. Methods The study was designed as a prospective, single center, randomized controlled trial. Children who underwent abdominal surgery under general anesthesia in the First Affiliated Hospital of Air Force Military Medical University from November 2019 to December 2020 were enrolled and randomly divided into 3 groups according to dexmedetomidine dose (0.4-μg, 0.7-μg, and 1.0-μg) using the random number table method. Dexmedetomidine at corresponding dose were given by intravenous pump 15-minutes before anesthesia induction at bases of the same other anesthesia methods. The heart rate and mean blood pressure during surgery, Ramsay sedation score, sedative-agitation score (SAS), and the face-legs-activity-cry-consolability behavioral tool (FLACC) after awakening from anesthesia, and adverse reactions within 24-hours after surgery were compared in children among the 3 groups. Results A total of 150 children were entered in the study, including 77 males (51.3%) and 73 females (48.7%), aged (7±1) years with weight of (22.4±4.6) kg. The surgeries were performed for inguinal hernia, hydrocele, cryptorchidism, and appendicitis in 81 (54.0%), 36 (24.0%), 19 (12.7%), and 14 (9.3%) children, respectively. The 150 children were randomly divided into dexmedetomidine 0.4-μg group, 0.7-μg group, and 1.0-μg group, with 50 children in each group. There were no statistically significant differences in gender, age, weight, American Society of Anesthesiologists grade, or separation anxiety among children of the 3 groups (all P>0.05). The postoperative recovery time [(12±3) min vs. (9±3) min] and time to extubation [(12±3) min vs. (9±3) min] of children in the 1.0-μg group were significantly longer than those in the 0.4-μg group (both P<0.001). While the differences of the 2 indexes above in children were not significantly when compared between the 1.0 and 0.7-μg groups and the 0.7 and 0.4-μg groups (all P>0.05). During the operation, the heart rate and MBP of children in the 0.7-μg group and the 1.0-μg group were significantly lower than those in the  0.4-μg group (both P<0.001). The Ramsay sedation scores of children when awakening from anesthesia, leaving the resuscitation room, and 1 hour after operation were significantly higher in the 0.7-μg group and the 1.0-μg group than those in the 0.4-μg group, while the SAS score and FLACC score were significantly lower (all P<0.05). Compared with the 0.4-μg group, the incidence of emergence agitation [12.0% (6/50) and 8.0% (4/50) vs. 30.0% (15/50)] and the total incidence of adverse reactions [22.0% (11/50) and 16.0% (8/50) vs. 44.0% (22/50)] in children of the 0.7-μg group and the 1.0-μg group were significantly lower (all P<0.05). Conclusion Infusion of dexmedetomidine 0.7-μg/kg before anesthesia induction in pediatric abdominal surgery under general anesthesia has little effect on the awakening from anesthesia, with good sedation effect and low incidence of adverse reactions, which is the optimal dosage.
  • Tang Yiheng, Cai Dachuan
    Adverse Drug Reactions Journal. 2025, 27(4): 232-237. https://doi.org/10.3760/cma.j.cn114015-20240729-00656
    Immune checkpoint inhibitors (ICIs) are widely used in the treatment of various malignant tumors. While achieving therapeutic benefits, immune-related adverse events (irAEs) caused by ICIs have also drawn clinical attention. irAEs can affect almost all organs in the body, and the diversity of clinical manifestations increases the difficulty for clinicians and pharmacists to diagnose and intervene. Therefore, finding reliable biomarkers that can accurately predict and diagnose irAEs has significant clinical value. This article reviews the research progress of biomarkers of ICIs-related adverse events, providing a reference for the safe application of these drugs in clinical treatment.
  • Xue Wenxin, Hao Tianlong, Chen Wei, Wang Jingxin, Cao Keming
    Adverse Drug Reactions Journal. 2025, 27(5): 308-312. https://doi.org/10.3760/cma.j.cn114015-20240729-00657
     Semaglutide is a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), which is commonly used in the treatment of type 2 diabetes mellitus and weight loss. Its weight loss effect was exerted mainly by suppressing appetite, delaying gastric emptying, promoting energy metabolism, and accelerating lipolysis. However, delayed gastric emptying can lead to residual gastric content, increasing the risk of pulmonary aspiration during anesthesia. This article reviews the effects and mechanisms of semaglutide on gastric emptying, and proposes preventive measures for perioperative pulmonary aspiration in patients treated with semaglutide by reviewing case reports and clinical studies on semaglutide-related delayed gastric emptying. This provides a reference for the safety of semaglutide treatment during the perio- perative period.
  • ADR系列问答
    . 2011, 13(1): 63-1.
  • Shen Changbo, Yang Wenkuan, Zhang Linli, Liu Yamei, Jin Mei
    Adverse Drug Reactions Journal. 2024, 26(8): 487-492. https://doi.org/10.3760/cma.j.cn114015⁃20240129⁃00069
    Objective To systematically evaluate and compare the efficacy and safety of oxcarbazepine and carbamazepine in the treatment of vestibular paroxysmia (VP). Methods Randomized controlled trials (RCTs) of oxcarbazepine versus carbamazepine in the treatment of VP, in which the outcome measures included response rate, visual analogue scale for vertigo and the attack frequency, and incidence of adverse events/reactions were collected by searching relevant databases at home and abroad (up to March 2023). The Cochrane Collaboration′s tool for assessing risk of bias was used to evaluate the quality of the included studies. RevMan 5.3?software was used for meta?analysis. The effect sizes of counting data were odds ratio (OR) and its 95% confidence interval (CI), and those of the measurement data were mean difference (MD) and its 95%CI. Results A total of 7 RCTs and 476 patients were entered in the analysis, including 236 in the oxcarbazepine group and 240 in the carbamazepine group. Meta analysis showed that there were no significant differences in the total effective rate of oxcarbazepine and carbamazepine in the treatment of VP [85.7% (168/196) vs. 85.0% (170/200), OR=1.07, 95%CI: 0.61-1.86], the decrease of visual analogue scale for vertigo after treatment (MD=0.40, 95%CI: -0.52-1.32) or the reduction of vertigo frequency after treatment (MD=1.15, 95%CI:-1.78-4.08). However, compared to the carbamazepine group, the overall incidence of adverse events/reactions, the incidence of dizziness/ataxia, and incidence of nausea/vomiting in oxcarbazepine group was significantly lower [13.6% (32/236) vs. 30.8% (74/240), OR=0.34, 95%CI: 0.22-0.55, P<0.001; 2.1%(5/236) vs. 7.9%(19/240), OR=0.32, 95%CI: 0.13-0.76, P=0.01; 2.4%(5/211) vs. 7.1%(15/211), OR=0.38, 95%CI: 0.15-0.95, P=0.04]. Conclusion Oxcarbazepine and carbamazepine have similar efficacy in the treatment of VP, but oxcarbazepine has better safety with lower incidence of adverse reactions in the nervous system and digestive system.

  • Chen Jie, Quan Shuping, Wang Ling, Wang Xiuli
    Adverse Drug Reactions Journal. 2024, 26(10): 588-593. https://doi.org/10.3760/cma.j.cn114015-20240407-00231
    Objective To summarize the evidence related to the prevention and nursing of iatrogenic botulism. Methods The relevant literature on prevention, nursing and management of iatrogenic botulinum in relevant websites and medical literature databases at home and abroad were systematically searched (up to December 30, 2023). Evidence-based methods were used to evaluate the quality of literature and conduct extraction and summarization of the evidence. Results A total of 14 literature was included, including 1 guideline, 6 expert consensus, 4 systematic reviews and 3 clinical decisions, all of which were of high overall quality. After summary and analysis of the evidence, a total of 7 evidence topics and 41 evidence-based evidences for the prevention and nursing of iatrogenic botulism were sorted out, including prevention and management, health education, early warning and evaluation, drug treatment management, supportive nursing, functional exercise, and psychological nursing. Conclusion The evidence of prevention and nursing of iatrogenic botulinum summarized by evidence-based method has a high overall quality, and the recommendations have high reference value in clinical nursing.
  • Song Yao, Yang Hongge, Wen Aiping
    Adverse Drug Reactions Journal. 2024, 26(10): 615-619. https://doi.org/10.3760/cma.j.cn114015-20240403-00222
    Objective To explore the efficacy and safety of low-dose rituximab in the treatment of idiopathic membranous nephropathy (IMN). Methods The medical record data of IMN patients treated with low-dose rituximab (375 mg/m2 by IV infusion, administration once, and then decided whether to add drugs according to the patient′s situation) were searched from the electronic medical record system of Beijing Friendship Hospital, Capital Medical University from January 1, 2020 to June 30, 2023. The patients′ gender, age, 24 hour urinary protein quantitation, plasma albumin, serum creatinine, and the number of CD19+ B cells in peripheral blood before and 1, 3, and 6 months after rituximab application were collected. The efficacy (complete remission, partial remission, and no remission) and the occurrence of adverse reactions were retrospectively analyzed. Results A total of 32 patients were enrolled in the study, including 24 males and 8 females, with mean age of (59±14) years. The 24 hour urinary protein of patients at 1, 3, and 6 months after the application of rituximab showed a decreasing trend, but the difference was not statistically significant (P>0.05); after medication, plasma albumin showed an upward trend when compared with that before medication [(23.85±5.65)g/L], with values of (28.06±5.91), (30.56±6.87), and (32.47±7.69) g/L, respectively, and the differences were statistically significant (P<0.05); the serum creatinine levels were within the reference range before and after medication, and the difference was not statistically significant (P>0.05); the number of CD19+ B cells in peripheral blood significantly decreased after medication, and the difference was statistically significant (P<0.05). The effective rate at 6 months after treatment was 65.62% (21/32), including complete remission rate of 9.38% (3/32), partial remission rate of 56.25% (18/32), and no remission rate of 34.38% (11/32). Eight patients experienced mild adverse reactions, all of which were improved after sympto- matic treatments. Conclusion Low-dose rituximab has good efficacy and safety in the treatment of IMN.
  • Adverse Drug Reactions Journal. 2025, 27(6): 383-384. https://doi.org/10.3760/cma.j.cn114015-20250530-00297
  • Cong Shan, Liu Yiming, Wei Xianping, Hou Jiqiu, Chen Junjun, Wang Dongxue
    Adverse Drug Reactions Journal. 2025, 27(3): 176-181. https://doi.org/10.3760/cma.j.cn114015-20240603-00410
    Objective To investigate and analyze the safety of empirical or experimental medication (EEM) for adult-onset Still disease (AOSD) before diagnosis. Methods The AOSD inpatients admitted to the Second Hospital of Jilin University from January 1, 2019 to December 31, 2023 were collected through hospital information system, and those who were misdiagnosed on admission were screened out. The main clinical characteristics, laboratory tests, misdiagnosis situation, the use of EEM and their adverse drug reactions (ADR), and the potential drug-drug interactions in the misdiagnosed patients were analyzed by descriptive statistics. Results During the set time period, a total of 49 patients with AOSD were admitted to the hospital, of which 16 (32.7%) were misdiagnosed with other diseases on admission. Among the 16 patients, 10 were male and 6 were female, with a median age of 53 years. The main clinical manifestations were fever (in 15 patients), arthralgia/arthritis (in 10 patients), lymphadenopathy (in 10 patients), rash (in 9 patients), pleural or pericardial effusion (in 6 patients), pneumonia (in 5 patients), splenomegaly (in 4 patients) and sore throat (in 4 patients). Abnormalities in laboratory tests included white blood cell count elevation (in 13 patients), platelets count elevation (in 8 patients), serum ferritin elevation (>500 μg/L, in 12 patients), and abnormal liver function (in 9 patients). The median time of treatment before admission was 5.5 months (11 days to 27.0 months), and the median time from admission to diagnosis of AOSD was 12 days. Before the diagnosis of AOSD, all patients received a long time of EEM, including antibiotics, traditional Chinese medicine preparations, liver-protection drugs, anti- allergic drugs and antiviral drugs in 15, 12, 11, 3 and 2 patients, respectively. Four patients experienced ADRs related to EEM, all of which were caused by antibiotics. There were potential interactions in the therapeutic drugs in 4 patients. Conclusion The misdiagnosis rate of AOSD was high. Patients might had accepted multiple EEMs before the definite diagnosis, which posed risks of ADRs and drug interactions.
  • Yang Ge, Xu Wei
    Adverse Drug Reactions Journal. 2019, 21(6): 473-474. https://doi.org/10.3760/cma.j.issn.1008-5734.2019.06.024
    A 67-year-old woman was treated with oral gefitinib 250 mg once daily for multiple metastasis of lung adenocarcinoma. After 23 days of treatment, the patient developed severe diarrhea with more than 10 times of watery stools within 24 hours. Gefitinib was stopped, montmorillonite powder and rehydration therapy were given. The patient was admitted to hospital on the 5th day of diarrhea. But her diarrhea was not improved and persistent hypokalemia, electrolyte disturbance, and paralytic ileus gradually appeared. The paralytic ileus was improved by fasting, gastrointestinal decompression, potassium and sodium supplementation, and supportive treatment. On day 11 of admission, the patient developed gastrointestinal bleeding. Pantoprazole, octreotide, aminomethylbenzoic acid, and transfusion of red blood cells and platelets were given. However, the patient′s condition continued to deteriorate. On day 16 of admission, he died of respiratory and circulatory failure.
  • ADR系列问答
    . 2011, 13(1): 63-2.
  • Zhao Danjie, Bian Yuan, Yin Qi'nan, Wang Yi, Tang Peng, Han Lizhu
    Adverse Drug Reactions Journal. 2025, 27(1): 44-49. https://doi.org/10.3760/cma.j.cn114015-20240513-00338
    Janus kinase inhibitors (JAKi) are a kind of small molecule targeted drugs used to treat a variety of immune-mediated inflammatory diseases by inhibiting the excessive response of a variety of cytokines. Currently, JAKi has shown good clinical efficacy, but it also has risk of major adverse cardiovascular events (MACE). The specific mechanism of JAKi-caused MACE is still unclear. This paper reviews the pharmacological molecular mechanisms and classification of JAKi and the research progress of MACE related to the JAKi (tolvaptan, baricitinib, ruxolitinib, upadacitinib, and abrocitinib) that have been approved for marketing in China. The risk factors that lead to MACE, including age, combined cardiovascular disease and  inflammatory diseases, types of JAKi, dosage forms, and treatment duration are analyzed, so as to provide reference for the clinical rational use of JAKi and better prevention of MACE related to JAKi.
  • Sun Tong, Liu Feng, Zhang Honglian
    Adverse Drug Reactions Journal. 2024, 26(11): 689-694. https://doi.org/10.3760/cma.j.cn114015-20240402-00212
    Epidermal growth factor receptor tyrosine kinase inhibitors (EGRF-TKIs) were standard therapeutic agents for advanced non-small cell lung cancer with positive EGFR mutations, most of these drugs could cause paronychia with various severity. EGFR-TKIs caused paronychia and periungual suppurative inflammation mainly through their pharmacological effects, which usually occurred 4 to 12 weeks after medication. The paronychia caused by EGFR-TKIs was manifested as acute paronychia firstly, and then might develop into purulent granuloma. The diagnosis of paronychia could base on the patient′s medical history, clinical symptoms, clinical examinations, and medication situation. Currently, there was no standard scheme to prevent and treat paronychia induced by EGFR-TKIs. The relatively effective measures included controlling risk factors, adjusting the regimen of EGFR-TKIs, using β-blockers, antibacterial drugs, local glucocorticoids and Chinese herbal medicines, etc. Severe paronychia could also be treated through surgical intervention.
  • 论著
    Wei Hongtao;Wang Jingyu;Shi Limin;Cheng Sheng;Diao Zongli;Wen Aiping
    . 2008, 10(1): 0-0.
    Objective:To study on the clinical characteristics of hepatic injury occurring with albendazole used for angiostrongyliasis caused by A. cantonensis. Methods: The clinical data of 39 patients with angiostrongyliasis caused by A. cantonensis who received albendazole and developed hepatic injury were collected. The age, sex, medication, clinical manifestations and prognosis of the patients were statistically analysed. Results: Thirtynine patients [27 men (69.23%) and 12 women (30.77%), average age (36.44±9.77) years] received albendazole 400 mg three times daily. The duration of therapy was 4~17 days. Of 39 patients, 35 received combination therapy with dexamethasone. The patients' ALT and AST levels increased from (17.77±7.94) U/L to (104.07±58.20), and (14.80±3.93) U/L to (45.48±29.77) U/L, respectively. After one month of liverprotective treatment, the patient's ALT and AST levels returned to normal limits.Conclusion: Hepatic injury occurring with albendazole used for angiostrongyliasis caused by A. cantonensis may be associaded with the dosage, duration, and combination therapy. The patients' ALT and AST levels can return to normal limits after live-protective treatment.
  • Xu Shuo, Xu Wenfeng, Kuang Yongmei, Jin Pengfei
    Adverse Drug Reactions Journal. 2024, 26(2): 93-100. https://doi.org/10.3760/cma.j.cn114015-20230607-00414
    Objective To develop the method of high performance liquid chromatography with diode array detector (HPLC-DAD) technology for detection of 20 chemical drugs possibly added into sleep aid dietary supplements such as sulpiride, ethosuximide, lamotrigine, zolpidem tartrate, melatonine, burspirone hydrochloride, phenobarbital, midazolam maleate, haloperidol, carbamazepine, phenytoin sodium, oxazepam, nitrazepam, alprazolam, clonazepam, estazolam, fupentixol dihydrochloride, thiopental, thioridazine hydrochloride and diazepam. Methods An Agilent Zorbax C18 column (250-mm×4.6-mm, 5-μm) was used for the separation, with gradient elution of acetonitrile and ammonium dihydrogen phosphate aqueous solution (adjust pH to 3.0 with phosphoric acid) as the mobile phase at the flow rate of 0.8-ml/min. The column temperature was 25-℃, and the detection wavelength was set at 220 and 280-nm. The specificity, system adaptability, linear relationship, limit of detection, limit of quantitation, recovery, precision, stability and repeatability of the HPLC-DAD technology in detection of the above 20 chemical drugs was evaluated. Results The HPLC-DAD technology had good specificity in detection of 20 chemical drugs, and the drug concentration had good linear relationship with peak area within certain ranges (correlation coefficients r ≥0.999-8). The average recoveries of 9 injections of 20 chemical drugs at low, medium, and high concentrations were 98.68%-99.85%, and the relative standard deviations of peak area variation were 0.57%-1.16%. The precision, repeatability, and stability of the method in detecting 20 chemical drugs were good. The limits of detection and quantitation were 0.05-1.59-μg/ml and 0.16-5.09-μg/ml, respectively. The established method was used to test 6 samples, and nitrazepam was detected in 1 sample. Conclusions The established method is accurate, easy to operate, and easy to promote. It can be used for the detection of 20 chemical drugs that may be added into sleep aid dietary supplements.
  • Wu Haiting, Wang Hanping, Ye Wei, Li Xuemei, Zheng Ke
    Adverse Drug Reactions Journal. 2025, 27(4): 245-247. https://doi.org/10.3760/cma.j.cn 114015-20240711-00533
    A 66-year-old female patient with lung adenocarcinoma was treated with crizotinib  [the first-generation anaplastic lymphoma kinase (ALK) inhibitors] 250 mg twice daily. Prior to treatment, the patient's liver and kidney functions were normal. One month after treatment, her serum creatinine (Scr) was 85 μmol/L, and alanine aminotransferase (ALT) was 115 U/L. After discontinuing crizotinib for 10 days, both Scr and ALT returned to normal. One month later, the patient underwent a right lower lobectomy. Crizotinib was restarted postoperatively, and she developed symptoms of lower limb edema and poor appetite. After more than 3 months of treatment, her Scr increased to 129 μmol/L, ALT was 96 U/L, and aspartate aminotransferase (AST) was 83 U/L. Crizotinib was then switched to alectinib (the second- generation ALK inhibitors) 600 mg orally twice daily, and the patient′s gastrointestinal symptoms and liver function were rapidly improved. However, her Scr continued to increase gradually (140 -150 μmol/L). Renal biopsy pathology indicated IgA nephropathy and acute tubular injury. After 4 months of alectinib treatment, Scr was 174 μmol/L, and the drug was promptly discontinued. One month after discontinuation, Scr decreased to 125 μmol/L. Due to tumor progression, the patient restarted alectinib at a reduced dose (300 mg twice daily). Three months later, Scr increased to 177 μmol/L. Subsequently, alectinib was replaced with lorlatinib (the third-generation ALK inhibitors) 100 mg once daily due to tumor progression. After 6 months of treatment, the tumor condition was controlled, and Scr decreased to 124 μmol/L.
  • 中药不良反应
    Liu Cheng;Jiang Junjie;Shen Bingxiang
    . 2008, 10(1): 0-0.

    A 56yearold man with right scapula comminuted fracture received cervus and cucumis polypeptide 32 mg dissolved in 500 ml of sodium chloride 0.9% by intravenous infusion on day 14 after the surgery of open reduction and internal fixation. After about 2 ml of initial infusion, he suddenly developed chest distress, palpitation, blushing, hidrosis, and vomiting. His blood pressure dropped from 130/76 mmHg to 80/50 mmHg. The infusion was stopped immediately and the patient received antishock therapy. One hour later, his symptoms were relieved.

  • 安全信息
    . 2008, 10(1): 0-0.
  • 中毒救治
    Li Runping;Zheng Hao;Zhang Yu;Zhang Weihua;Mu Chunfeng
    . 2008, 10(1): 0-0.

    Ethylene glycol is the main ingredient in antifreeze. Ethylene glycol undergoes enzymatic metabolism principally in the liver, and converses to glycoaldehyde, glycolate, glycoxylate, and oxalate successively. These metabolites can cause metabolic acidosis. The typical clinical features of ethylene glycol poisoning are drowsiness, coma, elevated blood pressure, tachycardia, and hyperventilation. Many paiblished case reports described three stages of ethylene glycol poisoning: a neurological stage (30 minutes to 12 hours after injection), central nervous system depression occurs; followed by a cardiopulmonary stage (12~24 hours after ingestion), metabolic acidosis and cardiopulmonary disorders occur; and finally, a renal stage (24~72 hours after ingestion), tubular necrosis and renal failure occur. The lethal dose of ethylene glycol is usually 1.4~1.6 ml/kg[about 100 ml in an about (70 kg)]. The diagnosis is based on history of exposure, clinical features, and determination of ethylene glycol and the major acidic metabolite, glycolate, concentrations in blood and urine. The general principles of treatment include emptying the stomach, correction of acidosis, antidotes (ethanol or fomepizole) administration, haemodialysis, and supportive therapy. This paper reports 3 cases of ethylene glycol poisoning. Three male patients aged 48 years ingested about 150 ml of ethylene glycol each. The patients were presented with headache (2 cases), abdominal discomfort and restlessness (1 case). The three patients developed unconsevousness 9 hours after ingestion, metabolic acidosis 12 to 18 hours after ingestion, and hematuria 24 hours after ingestion. The patients were treated with gastric lavage, haemodialysis, famotidine 40 mg, 20 ml of IV calcium gluconate 10%, IV sodium bicarbonate 4%, oral administration of 200 ml of spirit (containing ethanol 38%), and vitaminB6. And then two patients were perfectly recovered from their illness. One patient died 29 hours after ingestion of ethylene glycol.

  • Wang Daoyan, Gao Yanli, Sun Zuoyan, Chen Zhongguang
    Adverse Drug Reactions Journal. 2025, 27(4): 212-217. https://doi.org/10.3760/cma.j.cn114015-20250103-00007
    Objective To analyze the risk factors of hypocalcemia in 3-5 stages of chronic kidney disease (CKD) patients with hyperkalemia and non-dialysis after potassium lowering therapy. Methods Clinical data of 3-5 stages of CKD patients with hyperkalemia and non-dialysis treated in Linyi Central Hospital from January 2019 to November 2024 were collected through the electronic medical record system. According to whether the corrected calcium level after potassium lowering treatments was lower than 2.12 mmol/L, the patients were divided into hypocalcemia group and non-hypocalcemia group. The gender, age, body mass index, primary disease, disease duration, comorbidity, use of potassium lowering drugs, concomitant medication, and blood potassium, corrected calcium, carbon dioxide binding capacity, blood magnesium, blood phosphorus, estimated glomerular filtration rate, and total parathyroid hormone before potassium lowering treatments between the 2 groups were compared. Multiple logistic regression analysis was used to identify the risk factors for hypocalcemia in 3-5 stages of CKD patients with hyperkalemia and non-dialysis after potassium lowering therapy. Results A total of 260 patients were entered, including 58 with blood calcium lower than 2.12 mmol/L, and incidence of hypocalcemia was 22.3%. The differences in the baseline corrected calcium, blood phosphorus, carbon dioxide binding capacity, estimated glomerular filtration rate, and total parathyroid hormone between the hypocalcemia group and the non-hypocalcemia group were statistically significant (P<0.05). The factors with P<0.1, including primary disease, baseline corrected calcium, blood phosphorus, carbon dioxide binding capacity, estimated glomerular filtration rate, and total parathyroid hormone, were included in the multivariate logistic regression analysis. The results showed that the probability of hypocalcemia at baseline corrected calcium levels of 2.12-2.21, 2.22-2.31, and 2.32-2.41 mmol/L was 49.306 times, 13.651 times, and 13.342 times that of at ≥2.42 mmol/L, respectively. Low carbon dioxide binding capacity (odds ratio=0.909, 95% confidence interval: 0.836-0.987) was also a risk factor of hypocalcemia in 3-5 stages CKD patients with hyperkalemia and non-dialysis after potassium lowering therapy. Conclusions Three to five stages of CKD patients with hyperkalemia and non- dialysis are prone to hypocalcemia after potassium lowering therapy. The low levels of baseline corrected calcium and carbon dioxide binding may be closely related to the occurrence of hypocalcemia in 3-5 stages of CKD patients with hyperkalemia and non-dialysis after potassium lowering therapy.
  • 安全信息
    . 2008, 10(1): 0-0.
  • 法规准则
    . 2008, 10(5): 0-0.
  • Wu Liang, Chen Jingbao, Chen Xiaoxiao, Jiang Shanyue, Shen Yun
    Adverse Drug Reactions Journal. 2025, 27(4): 218-224. https://doi.org/10.3760/cma.j.cn114015-20240719-00606
    Objective To understand the quality of adverse drug reaction (ADR) reports in Lu′an Hospital of Traditional Chinese Medicine (our hospital) and its change trend in recent years, and explore the methods of objectively evaluating the quality of ADR reports. Methods According to the 20 evaluation indicators of the ADR report quality evaluation scoring table in the Appendixes 5 of Provisions for Adverse Drug Reaction Reporting and monitoring, the ADR reports submitted to the National Center for ADR Monito- ring from 2013 to 2022 by our hospital were evaluated. The weighted technique for order preference by similarity to ideal solution (TOPSIS) combined with rank-sum ratio (RSR) model was used to rank the quality of ADR reports into the following 5 grades: excellent, good, medium, qualified and unqualified, according to the weight of each evaluation index. The quality grading results were tested to determine the rationality of grading. Results A total of 3 947 ADR reports were included in the analysis, including 1 361 new/serious ADR reports (34.5%), and the average score of quality evaluation index was 87.9. After 2016, the number of ADR reports and the proportion of reports with scores ≥ 80 increased-significantly. Among the 20 evaluation indicators, 10-had a high pass rate, 7 had a medium or upper pass rate, and 3 had a low pass rate. The TOPSIS-RSR model was used to classify the quality of ADR reports. The overall proportions of excellent, good, moderate, qualified, and unqualified reports were 4.7% (186/3 947), 23.0% (908/3 947), 45.3% (1 787/3 947), 23.4% (925/3 947), and 3.6% (141/3 947), respectively. The homogeneity of variance test showed that each grade met the homogeneity of variance, and the analysis of variance results showed that the differences between every 2 grades were statistically significant (P<0.001), indicating that the quality grading was reasonable. Conclusions After 2016, the quantity and quality of ADR reports in our hospital have significant improvement, but there are still some evaluation indicators with low pass rate. Using the weighted TOPSIS-RSR model to grade the quality of ADR reports can more objectively reflect the quality of ADR reports.
  • Hu Ya'nan, Yue Wei, Ling Ling, Zhang Jinwei
    Adverse Drug Reactions Journal. 2025, 27(4): 238-244. https://doi.org/10.3760/cma.j.cn114015-20241109-00140
    Neuroinflammatory response runs through the pathological process of epilepsy, and the regulation of proinflammatory factors such as (tumor necrosis factor-α, TNF-α), (interleukin, IL)-1β, IL-6 and Toll-like receptors 4/nuclear factor-kappa B signaling pathways may help improve epilepsy symptoms. Traditional Chinese medicines with anti-epileptic effects can be mainly divided into the following 6 categories: Pinggan Xifeng drugs (平肝息风药, liver-calming and wind-extinguishing herbs), Qingre drugs (清热药, heat-clearing drugs), Huatan drugs (化痰药, phlegm-relieving drugs), Huoxue Huayu drugs (活血化瘀药, circulation-promoting and stasis-removing drugs), Buxu drugs (补虚药, tonifying drugs), and Kaijiao drugs (开窍药, consciousness-restoring drugs). The active ingredients contained in these traditional Chinese medicines can play a therapeutic role in epilepsy treatment by regulating the release of key proinflammatory factors and inflammatory signaling pathways. Adverse reactions caused by Chinese patent medicines involve a variety of factors, which can be summarized into the process of medicinal materials preparation, the principle of traditional Chinese medicine compatibility, the accuracy of dialectical treatment, individual differences, etc. When using anti-epileptic Chinese medicine in clinical practice, it should be flexibly applied according to specific conditions to achieve the goal of precise treatment.
  • Yu Fuwen, Liu Yubo, Tian Shuxia
    Adverse Drug Reactions Journal. 2025, 27(4): 251-253. https://doi.org/10.3760/cma.j.cn114015-20240724-00624
     A 71-year-old female patient underwent laparoscopic right hemicolectomy due to intestinal obstruction caused by malignant colon tumor. The patient had a fever 7 hours after surgery. Because of suspected abdominal infection, intravenous infusion of 2 g mezlocillin was given once every 8 hours on the day of operation. Three days later, the patient was given simnotrelvir (0.75 g)/ritonavir (0.1 g) once every 12 hours because of the positive nucleic acid test of novel coronavirus. Two days later after medication, the patient′s serum creatinine (Scr) increased from 40.2 μmol/L before treatment to 165.1 μmol/L, and the estimated glomerular filtration rate (eGFR) decreased from 100.6 ml/(min·1.73 m2) before treatment to 26.7 ml/(min·1.73 m2), without significant oliguria. Drug-induced acute kidney failure (AKI) was suspec- ted, and mezlocillin and simnotrelvir/ritonavir were discontinued. After 3 days of drug withdrawal, the patient′s renal function was improved, with Scr 78.1 μmo1/L; after 15 days, the Scr was 49.7 μmo1/L and eGFR was 93.8 ml/(min·1.73 m2). It was considered that the patient′s AKI was likely to be related to simnotrelvir/ritonavir. However, the possibility of nephrotoxicity enhancement due to the combination of simnotrelvir/ritonavir and mezlocillin could not be excluded. 
  • Wang Kexin, Sun Bao, Luo Zhiying, Que Suyun, Zhang Bikui, Liu Wenhui
    Adverse Drug Reactions Journal. 2025, 27(4): 253-256. https://doi.org/10.3760/cma.j.cn114015-20240731-00660
    A 55-year-old male patient received immunotherapy combined with chemotherapy regimen(intravenous infusions of tislelizumab 200 mg on day 1, paclitaxel protein-bound 470 mg, and carboplatin 500 mg on day 1) after surgery for left upper lung squamous cell carcinoma, with 21 days as a treatment cycle. After more than half a month of medication in the 1st cycle, the patient developed multiple symmetrical purple red bruises on both lower limbs, which did not fade when pressed. The purple red bruising disappeared the next day after treatment with anti-allergic drugs. After 3 days of medication in the 3rd cycle, the patient developed a large number of scattered red papules on both lower limbs, protruding from the surface of the skin and accompanied by itching, a small number of red papules were scattered on both upper limbs and the face; after 15 days, the patient felt poor appetite; after 16 days, the patient experienced abdominal pain accompanied by vomiting and loose yellow stool. Laboratory tests showed a blood creatinine level of 204 μmol/L and occult blood in urine (+++). Pathological examination of skin tissue at the lesion site of the patient suggested IgA vasculitis (IgAV). After excluding other factors such as primary disease and infection, it was considered that the IgAV was probably related to tislelizumab. Tislelizumab was discontinued, anti-allergic and anti-inflammatory drugs, and glucocorticoid were given. After 2 weeks of treatments, the skin purpura gradually disappeared, and the abdominal pain and renal function indicators were improved. After fully aware of the risks, the patient was restarted tislelizumab immunotherapy combined with chemotherapy, and anti-allergic drugs were add at the same time. IgVA did not recur.
  • Guo Ningning, Zhang Yanli
    Adverse Drug Reactions Journal. 2025, 27(4): 248-251. https://doi.org/10.3760/cma.j.cn114015-20240918-00050
    A 70-year-old male patient was treated with venetoclax 100 mg orally once daily for acute myeloid leukemia. Before treatment, laboratory tests showed serum potassium 3.61 mmol/L, serum calcium 1.88 mmol/L, inorganic phosphate 1.33 mmol/L, serum uric acid 276.3 μmol/L, aspartate amino- transferase (AST) 23 U/L, gamma-glutamyl transferase (GGT) 179 U/L, and lactate dehydrogenase (LDH) 797 U/L. Six hours later of medication, the patient experienced chest tightness, wheezing, fever with chills, and the highest body temperature was 38.3 ℃. Laboratory tests showed serum potassium 5.54 mmol/L, serum calcium 1.76 mmol/L, inorganic phosphate 3.41 mmol/L, serum uric acid 827.2 μmol/L, AST 205 U/L, GGT 157 U/L, LDH 4 789 U/L, and D-dimer 51.19 mg/L, respectively. It was considered that there was a high possibility of tumor lysis induced by venetoclax, and the drug was immediately stopped. Symptomatic treatments were given, including oxygen inhalation, electrocardiogram monitoring, fluid infusion, alkalinization of urine, and uric acid reduction. The fever of the patient was alleviated on the day of drug withdrawal, the symptoms of chest distress and asthma were improved the next day, and 3 days later, laboratory tests showed serum potassium 4.24 mmol/L, serum calcium 2.02 mmol/L, inorganic phosphate 1.76 mmol/L, serum uric acid 275.0 μmol/L, AST 37 U/L, GGT 80U/L, LDH 1 146 U/L, and D-dimer 7.97 mg/L; venetoclax treatment was resumed and the tumor lysis syndrome-related symptoms did not recur.
  • Li Bao, Li Jie, Sun Xiubo, Yu Ling
    Adverse Drug Reactions Journal. 2025, 27(5): 318-320. https://doi.org/10.3760/cma.j.cn114015-20240719-00612
    A 42-year-old female patient received toremifene 60 mg orally once daily for 5 years after breast cancer surgery. She had a regular menstrual cycle and no history of abnormal bleeding. For more than 1 month, she experienced irregular vaginal bleeding, which worsened for 3 days. The transvaginal color doppler ultrasound revealed endometrial thickening, and laboratory tests showed red blood cell count 1.8×1012/L and hemoglobin 35 g/L. The clinical diagnosis was abnormal uterine bleeding, endometrial thickening, and severe anemia. Symptomatic and supportive treatments, such as hemocoagulase, human erythropoietin, oxytocin, cefuroxime, and blood transfusion were given immediately. Civen the suspicion that toremifene-induced endometrial hyperplasia was the cause of abnormal uterine bleeding, toremifene was discontinued the following day. The symptomatic treatments (including blood transfusion) were continued, and iron supplementation was given. On the third day after discontinuation of toremifene, the patient underwent diagnostic hysteroscopic curettage. The postoperative pathological examination showed endometrial hyperplasia. The next day, the patient had no significant vaginal bleeding, with red blood cell count 3.6×1012/L and hemoglobin 93 g/L. Reexamination at 4 weeks revealed red blood cell count 4.3×1012/L and hemoglobin 135 g/L.
  • Wang Xin, Wang Zimin, Chen Bing, Cai Haodong
    Adverse Drug Reactions Journal. 2025, 27(5): 303-307. https://doi.org/10.3760/cma.j.cn114015-20241104-00129
    Prescribing cascade is a common inappropriate drug use, which will produce and amplify the risk of polypharmacy, causing unrecognized adverse drug reactions or drug-induced diseases, but it is often ignored by clinicians and pharmacists. Prescribing cascade can not only cause harm to patients, but also lead to waste of medical resources and increases the medical burden. This paper reviews the related research progress of the prevention, identification and management of the prescribing cascade, and puts forward suggestions on the identification, termination and research methods of the prescribing cascade. Chinese medical staff should improve their understanding of prescribing cascade, strengthen relevant research, understand the current situation and characteristics of prescribing cascade in China, formulate a list of prescription cascade and study relevant management strategies.
  • Lin Zhiqiang, Xiao Jianxiong, Wu Ruihong, Pan Weiyi, Chen Zhifei, Wang Qin
    Adverse Drug Reactions Journal. 2025, 27(4): 225-231. https://doi.org/10.3760/cma.j.cn114015-20240620-00476
    Objective To analyze and compare the reporting data of adverse events following immunization (AEFI) of influenza vaccines in Fujian Province from 2019 to 2023. Methods Using the National Immunization Program Information Management System, the AEFI reports and vaccination data of influenza vaccines in Fujian Province from 2019 to 2023 were collected, and the reporting rates and clinical characteristics of AEFI of 6 types of influenza vaccines were compared. The 6 types of vaccines in the analysis were as follows: trivalent inactivated influenza vaccines (IIV3) for 6-35 months old people, IIV3 for ≥3 years old people, trivalent live attenuated nasal spray vaccine (LAIV3) for 3-17 years old people, quadrivalent inactivated influenza vaccines (IIV4) for 6-35 months old people, IIV4 for ≥6 months old people, and IIV4 for ≥3 years old people. Results From 2019 to 2023, a total of 87 687.21 million doses of influenza vaccine were vaccinated in Fujian Province, and 510 cases of AEFI were reported, with a reporting rates of 5.82 per 100 000 doses. Among the 510 cases, 443 (86.86%) were general reactions, 56 (10.98%) were abnormal reactions, 1 (0.20%) was psychogenic reactions, and 10 (1.96%) were coincidence. There were no reports of vaccination accidents and vaccine quality accidents. The reporting rates of AEFI were relatively higher in 2019 and 2020 (18.38 and 18.00 per 100 000 doses, respectively), and lower in 2021, 2022 and 2023 (8.91, 10.68 and 2.30 per 100 000 doses, respectively); the differences were statistically significant (all P<0.05). The differences of reporting rates of AEFI between  IIV3 for 6 35 months old people and IIV4 for 6-35 months old people, the injectable vaccines and nasal spray vaccines were not statistically significant. However, the reporting rates of overall AEFI, general reactions and abnormal reactions of IIV3 for ≥3 years old people were all higher than those of IIV4 for ≥3 years old people (7.77 per 100 000 doses vs. 3.88 per 100 000 doses, 6.18 per 100 000 doses vs. 3.59 per 100 000 doses, 1.41 per 100 000 doses vs. 0.19 per 100 000 doses). The reporting rates of overall AEFI and general reaction of IIV3 for 6-35 months old people were both higher than those of IIV3 for ≥3 years old (16.47 per 100 000 doses vs. 7.77 per 100 000 doses, 13.05 per 100 000 doses vs. 6.18 per 100 000 doses), and the differences were statistially significant (all P<0.05). The reporting rates of general abnormal reactions of IIV4 for 6-35 months old and ≥ 6 months old people were both higher than those of IIV4 for ≥3 years old people (14.73 per 100 000 doses and 9.52 per 100 000 doses vs. 3.88 per 100 000 doses); the reporting rates of general reactions and abnormal reactions of IIV4 for ≥6 months old people were both higher than those of IIV4 for ≥3 years old people (12.94 per 100 000 doses vs. 3.59 per 100 000 doses, 1.34 per 100 000 doses vs. 0.19 per 100 000 doses), the dif- ferences were statistcially significant (all P<0.05). In terms of clinical features, the reporting rates of fever (37.6-38.5 ℃ and ≥ 38.5 ℃), local redness and swelling (diameter 2.6-5.0 cm), and local induration (diameter  ≤2.5 cm and 2.6-5.0 cm) after vaccination of IIV3 for ≥3 years old people were higher than those of IIV4  for ≥ 3 years old people (1.41 per 100 000 doses vs. 0.64 per 100 000 doses, 3.00 per 100 000 doses vs. 1.16 per 100 000 doses); the reporting rates of allergic rash and angioedema of IIV3 for ≥ 3 years old people were higher than those of IIV4 for ≥3 years old people (0.53 per 100 000 doses vs. 0.12 per 100 000 doses, 0.35 per 100 000 doses vs. 0); the differences were statistically significant (all P<0.016 7). Conclusions The reporting rates of AEFI for influenza vaccines in Fujian Province from 2019 to 2023 was showing a downward trend. The AEFI was mainly general reactions. The reporting rates of AEFI were different among dif- ferent influenza vaccines, but the overall safety was good.
  • 安全信息
    . 2008, 10(1): 0-0.
  • Zhang Jianjiang, Dou Wenjie
    Adverse Drug Reactions Journal. 2025, 27(6): 321-324. https://doi.org/10.3760/cma.j.cn114015-20250424-00225
    Due to physiological and metabolic characteristics and disease characteristics being different from adults, such as the high incidence of infectious diseases, children are at a high-risk of acute kidney injury (AKI) related to anti-bacterial agents, and there were many challenges in prevention and treatment. The hot issues in the research of anti-bacterial agent-related AKI in children, including the study of nephrotoxicity mechanism of anti-bacterial agents, the exploration of early biomarkers, and the optimization of treatment strategies, are expounded in this article. In the future, it is recommended to strengthen researches on child specificity, deepen basic researches, optimize monitoring plans for pediatric treatment drugs, and establish a pediatric drug monitoring system,  so as to provide references for rational clinical drug use of the anti-bacterial agents and further researches on AKI.
  • Zhao Manman, He Runcheng, Yang Ying, Zuo Zeping, Cao Xinyao, Wang Chao, Wen Nie, Wang Sanlong, Geng Xingchao, Wang Zhibin, Zhou Xiaobing
    Adverse Drug Reactions Journal. 2024, 26(9): 543-550. https://doi.org/10.3760/cma.j.cn114015-20240202-00076
    To explore the effects of maternal exposure to Morinda officinalis oligosaccharides (MOO) during lactation on the Sprague?Dawley (SD) maternal rats and their offspring′s growth and development. Methods Seventy?two female rats with a surviving litter size of ≥ 6 were divided into the excipients control group, MOO low?dose group (50?mg/kg), MOO medium?dose group (160?mg/kg), and MOO high?dose group (500?mg/kg) using a snake-shaped grouping based on body weight, with 18 rats per group. The rats were gavage fed once daily until 20 days of delivery. The response of maternal rats after MOO exposure during lactation, as well as the appearance, response, gross anatomical abnormalities of their F1 and F2 offspring were observed. The body weight and food intake of maternal rats during lactation and those of their offspring before and after weaning were measured. The behavior (central nervous system function) of the F1 and F2 offspring was evaluated using functional observation battery (FOB). The learning and memory function of the F1 offspring was evaluated using Y?maze test. The male and female F1 offspring in the same dose group were mated when they were raised to 10?12 weeks in order to observe the reproductive function of F1 female rats. Results Compared with the excipients control group, no abnormality was found in the clinical observation of maternal rats in the 3 MOO exposure groups during lactation, and there was no significant differences in their body weight and daily food intake during lactation (all P>0.05). No significant effects were found on the appearance, clinical symptoms, gross anatomy, body weight, and food intake of the F1 and F2 offspring after maternal rats receiving MOO exposure during lactation. In the FOB of the F1 and F2 offspring and the Y?maze test of F1 offspring, few differences in MOO exposure groups were observed and lack of significant dose?response relationship. After pregnancy, there were no statistically significant differences in the number of corpus luteum, implantation number, birth index, delivery index, survival index, and weaning index in F1 female offspring of maternal rats exposed to MOO at different doses during lactation compared with those of the excipients control group (all P>0.05). Conclusions There were no obvious toxic reactions in maternal rats after exposure to different doses of MOO during lactation, nor in the growth and development, nervous system, learning and memory, and reproductive function of their offspring.
  • 政策法规
    . 2004, 6(6): 395-397.
  • Deng Qiying, Tian Shanshan, Wu Tingfang, Li Anning, An Fengrong, Wang Gang
    Adverse Drug Reactions Journal. 2025, 27(5): 296-302. https://doi.org/10.3760/cma.j.cn114015-20250303-00110
    Objective To analyze the clinical characteristics of dissociative symptoms induced by esketamine hydrochloride nasal spray in patients with treatment-resistant depression (TRD). Methods The medical records of patients in phase Ⅲ clinical trials for the treatment of TRD who received esketamine hydrochloride nasal spray in Beijing Anding Hospital, Capital Medical University from June 2018 to February 2021 were collected. The general situation of patients (age, gender, comorbid diseases, etc.), the medication of esketamine hydrochloride nasal spray, the combined use of antidepressants, the time from medication to the occurrence of dissociative symptoms each time, duration, severity, evaluation results of causal relationship with esketamine application, intervention and prognosis were recorded, and a retrospective descriptive statistical analysis was performed. Results A total of 21 patients with TRD were enrolled in the study, including 17 (81.0%) with dissociative symptoms, 10 males and 7 females; the age ranged from 20 to 53 years, with a median age of 36 years. All patients were treated with esketamine hydrochloride by nasal spray. The first dose was 56 mg, and the other seven doses were 56 mg or 84 mg, twice a week, lasting for 4 weeks. The 17 patients were all given combination treatment with oral antidepressants. A total of 88 times of dissociative symptoms occurred in the 17 patients. The time from medication to the onset of dissociative symptoms ranged from 4 to 128 min, with a median time of 15 min. The duration of dissociative symptoms ranged from 12 to 326 minutes, with a median time of 70 minutes. The dissociative symptoms were mostly mild. The causal relationship analysis between the esketamine hydrochloride nasal spray and the dissociative symptoms showed that it was definitely related in 6 cases, probably in 1 case, and possibly in 10 cases. The dissociative symptoms in all patients were subsided without intervention. Conclusions Esketamine hydrochloride nasal spray can cause dissociative symptoms in patients with TRD, most of which occur within 30 minutes after the treatment. The duration of symptoms in most patients is less than 120 minutes, most of which are mild and can subside on their own, and the prognosis is good.
  • Dou Wei, Liu Xin, Zuo Wei, Yu Jiaxin, Wu Jiayu, Zhang Bo
    Adverse Drug Reactions Journal. 2025, 27(6): 362-368. https://doi.org/10.3760/cma.j.cn114015-20240802-00670
    Prescription sequence symmetry analysis (PSSA) is one of the important methods for post-marketing pharmacovigilance based on the real-world medical prescription databases. It can be used to detect prescription cascades and mine adverse drug reaction (ADR) signals, which has been verified by many studies. PSSA shows high specificity and medium sensitivity in identifying ADR. It can quantify the correlation or risks of ADR. It is easy to use and simple in algorithm, and it has good robustness to some non time-dependent confounding factors. However, the results may be affected by some human confounding factors and data quality. This paper reviews the principle, calculation method, application scope, and precaution of PSSA by reviewing related literature on PSSA domestically and abroad, in order to provide reference for pharmacovigilance in China.
  • Zhou Pengxiang, Xu Xinwen, Wang Xiaoling, Zhao Ruiling, Zhao Zhigang
    Adverse Drug Reactions Journal. 2025, 27(6): 339-347. https://doi.org/10.3760/cma.j.cn114015-20240828-00017
    Objective To explore the differences on contraindication information for children in domestic and foreign drug instructions, and provide reference for improving the relevant information in Chinese drug insert sheets. Methods Chinese drug insert sheets of chemicals and biological products contained in the China Pharmacopoeia 2020 and those of the western medicines in the 2023 China′s Basic Medical Insurance, Work-related Injury Insurance and Childbirth Insurance Drug Catalog were collected; drugs that were marked as contraindication for children were selected and relevant contraindication information in the Chinese drug insert sheets was collected. Instructions of the above-mentioned drugs approved by the U.S. Food and Drug Administration (English labels) were also collected, and the information on pediatric medication was reviewed and compared with the Chinese drug insert sheets. Results A total of 222 drugs were labeled as contraindication for children in the Chinese drug insert sheets, of which 149 were available for their English labels; 123 drugs (17.5%) were not labeled as contraindication for children in English labels, and 26 (82.5%) were labeled. The 123 drugs that were not labeled as contraindication for children in the English labels included the following conditions: 58 were labeled as contraindication for children of some age in the Chinese drug insert sheets but not in the English labels, and relevant medication information was provided; 40 were labeled as contraindication for children of some age group in the Chinese drug insert sheets but was described as the effectiveness and safety of the use for children have not yet been determined for this age group in the English labels; 13 were labeled as contraindication for children in the Chinese drug insert sheets, but the medication information on children in the English labels was not clear or missing; 12 were labeled as contraindicated for children in Chinese drug insert sheets but not in the English labels, only expressed as not yet determined or not recommended for use, etc., with inconsistent age group. Among the 26 drugs labeled as contraindication for children in both Chinese and English instructions, the contraindication age group were the same in above 2 instructions for 20 drugs, and were inconsistent for the other 6 drugs; reasons for contraindication were described in both the 2 instructions for 17 drugs (13 were consistent, 4 were inconsistent), only in English labels for 8 drugs, and only in Chinese drug insert sheets for 1 drug. Conclusions Many drugs are labeled as contraindication for children in Chinese drug insert sheets, but reasons for contraindication are rarely explained. Differences in children′s age in contraindications exist for some drugs between the Chinese drug insert sheets and English labels. The information on contraindications for children in Chinese drug insert sheets still needs to be further improved.
  • Chen Shuifang, Chen Hui, Chen Xuemei, Zheng Qianwen, Zheng Dong
    Adverse Drug Reactions Journal. 2025, 27(5): 260-267. https://doi.org/10.3760/cma.j.cn114015‑20240802‑00679
    Objective To explore the role of glutathione peroxidase 4 (GPX4)-dependent ferroptosis in diclofenac-induced kidney injury. Methods Human kidney tubular epithelial cells (HK-2 cells) were cultured and then divided into 3 groups: control group, diclofenac group, and iron death inhibitor ferrostatin-1 (Fer-1) group. The same amount of 1% Fer-1 (final concentration 10 μmol/L) and phosphate buffered saline was respectively added to cells in the Fer-1 group and the other 2 groups. After 48 hours of culture, diclofenac 200 μmol/L was added to cells in the diclofenac group and the Fer-1 group. The cell viability of each group was detected by cell counting kit-8 (CCK-8). The cell cycle, apoptosis and intracellular reactive oxygen species (ROS) levels were detected by flow cytometry. The levels of intracellular iron ion, lactate dehydrogenase (LDH), malondialdehyde (MDA) and GPX4 were detected by enzyme-linked immunosorbent assay. The expression level of GPX4 was detected by Western blotting method. Results Compared with the control group, the cell viability and G1 phase cell percentage of the diclofenac group were significantly lower, and compared with the diclofenac group, those were significantly higher (all P<0.05). The apoptosis rate of diclofenac group was significantly higher than that of the control group (P<0.05), but there was no significant difference in apoptosis rate between Fer-1 group and diclofenac group (P>0.05). Compared with the control group, the intracellular ROS, iron content, LDH, and MDA levels were significantly higherin the diclofenac group, while the expression level of GPX4 was lower (all P<0.05). However, the ROS, iron content, LDH, and MDA levels in the Fer-1 group were lower than those in the diclofenac group, while GPX4 expression was higher than that in the diclofenac group (all P<0.05). Conclusion Diclofenac can induce ferroptosis in HK-2 cells and inhibiting the ferroptosis can alleviate cell injury, suggesting that GPX4-dependent ferroptosis may be involved in kidney injury induced by diclofenac.
  • Shi Xiaowen, Li Chang, Fang Wenjian, Du Lin
    Adverse Drug Reactions Journal. 2025, 27(5): 288-296. https://doi.org/10.3760/cma.j.cn114015-20241011-00087
    Objective To compare and analyze the application efficacy of active surveillance versus passive surveillance in post-marketing safety monitoring of the group A and C meningococcal polysaccharide vaccine(MPSV-AC). Methods Safety data for MPSV-AC from its market launch in November 2011 to June 2024 were collected from Beijing Zhifei Lyuzhu Biopharmaceutical Co., Ltd., and categorized into active and passive surveillance data based on acquisition methods. Active surveillance data were derived from adverse events cases observed in the company′s phase Ⅳ clinical trial. Passive surveillance data were carried out by the Pharmacovigilance Department through the drug adverse reaction direct reporting system, which downloaded all adverse events following immunization(AEFI) case reports. Cases of adverse events under active surveillance that were "definitely related", "probably related", "possibly related", or “possibly unrelated” were classified as adverse reaction cases, and cases of passive surveillance that were classified as "general reaction" or "abnormal reaction" were classified as adverse reaction cases, and were counted according to the number of cases. For cases where different clinical manifestations of adverse reactions or preferred terminology were present in the same one patient, the number was counted separately. Descriptive epidemiological methods were used to describe the incidence of adverse reaction reports, the distribution of clinical manifestations, adverse reactions recorded and not recorded in the instructions and adverse reactions outcomes of two monitoring methods. The differences in the incidence of reported adverse reactions between active and passive surveillance were compared and analysed. Results A total of 922 patients with MPSV-AC adverse reaction reports were obtained through two monitoring modes, and 1 308 adverse reactions were occurred. In the active surveillance, the number of vaccination doses was 9 999, and 579 patients with adverse reactions were reported with 911 adverse reactions. In the passive surveillance, the number of vaccination doses was 4 185 800, and 343 patients with adverse reactions were reported with 397 adverse reactions. The incidence of reported adverse reactions in the passive surveillance was lower than in the active surveillance, and the difference was statistically significant [0.008% (343/4 185 800) vs. 5.791% (579/9 999), P<0.001]. The age range for active surveillance was ≥2 to<7 years old; the age range of passive surveillance was 0-15 years old, with the highest proportion of those aged ≥2 to<7 years old [79.30% (273/343)]. The clinical manifestation that topped the composition ratio of major adverse reactions for both surveillanceme thods was fever, but systemic symptoms such as malaise and anorexia were more frequently reported in active surveillance, whereas signs visible on the surface such as allergic rash, erythema and hard nodules were reported in passive surveillance. The proportion of serious adverse reactions from active surveillance was 0.22%(2/922), which were upper respiratory tract infection and febrile convulsions. Of the adverse reactions not included in the specification, those from active surveillance mainly involved infections and invasive diseases [77.32% (75/97)], and those from passive surveillance mainly involved diseases of the skin and subcutaneous tissues(6/12). All 579 patients in the active surveillance adverse reaction reports were monitored until cured; in the passive surveillance, 199 cases (50.13%, 199/397) were cured, 168 cases (42.32%, 168/397) were improved, and 30 cases (7.56%, 30/397) were unknown. Conclusions Active surveillance is irreplaceable for postmarketing safety evaluation of vaccines, as it comprehensively captures safety signals, indicating good safety of MPSV-AC. A multi-source data integration platform could be established in the future.
  • Lan Xiaohong, Zhou Yonggang, Wei Wei, Zhang Ye, Chen Ying, Li Xiang, Chen Shudong
    Adverse Drug Reactions Journal. 2025, 27(5): 268-273. https://doi.org/10.3760/cma.j.cn114015‑20240806‑00690
    Objective To explore the effect of Shenxianling granules on the pharmacokinetics of ondansetron. Methods A method for detecting the plasma concentration of ondansetron using highperformance liquid chromatography (HPLC) was established. The reliability of the method was validated through specificity, linear relationship, precision, stability, repeated experiments, and sample recovery rate testing. Thirty six healthy male New Zealand rabbits were randomly divided into 2 groups, with 18 rabbits in each group. Rabbits in the single ondansetron group (single drug group) received intravenous injection of ondansetron 0.92?mg/kg through the ear vein. Rabbits in the Shenxianling granules combined with ondansetron group (combination drug group) were firstly given 575 mg/kg of Shenxianling granules by gavage continuously for 10 days, and on the morning of the 11th day, ondansetron 0.92?mg/kg was intravenously injected. Blood samples were collected before administration and at 5 minutes, 10?minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours and 24 hours after administration of ondansetron. The blood concentration of ondansetron was detected using HPLC method and pharmacokinetic parameters were calculate. Results Two New Zealand rabbits in the combination drug group developed agitation and cough, and then died on the second and fifth day of gavage, respectively. Therefore a total of 18 and 16 rabbits in the single drug group and the combination drug group completed the experiment, respectively. After ondansetron administration, the plasma concentration of ondansetron increased rapidly in the single drug group and remained at low levels in the combination drug group. From 5 minutes to 10 hours after administration, the plasma concentration of ondansetron at the 13 blood sampling time points in the combination drug group was significantly lower than that in the single drug group, and the differences were statistically significant (all P<0.001). Compared with the single drug group, the plasma clearance half?life of ondansetron in the combination drug group was significantly prolonged, the peak time, peak concentration, concentration at the last time and area under the curve (AUC) were all significantly reduced, and the percen- tage of residual or extrapolated area to the overall AUC, apparent volume of distribution, and clearance/bioavailability ratio were significantly increased; the differences were statistically significant (all P<0.001). Conclusions There is a significant interaction between Shenxianling granules and ondansetron, leading to a decreased plasma concentration of ondansetron. The mechanism may be related to Shenxianling granules altering the tissue distribution of ondansetron within the body.
  • 中药不良反应
    Zhang Guixiang
    . 2008, 10(1): 0-0.

    A 27yearold female patient received oral Shaofuzhuyu granules 1.6 g thrice daily for menoxenia after artificial abortion. Two months after administration, the patient developed yellowish of the skin and dark urine. She continued to take Shaofuzhuyu granules for more than 1 month, and her symptoms were worsen accompanied by asthenia, nausea, and vomiting. Examination showed her liver function was abnormal. Shaofuzhuyu granules were discontinued. Despite liverprotective treatment for two weeks, her symptoms were not relieved. The patient was then admitted to hospital. Liver function tests revealed the following levels: ALT 130 U/L, AST 330 U/L, TBil 141.4 μmol/L, and DBil 130.7 μmol/L. A virological examination showed that hepatic A, B, C, D, and E viruses were negative, and a immunopathologic examinatin of liver tissue revealed there was no hepatitis virus. She was diagnosed with druginduced liver damage and was treated with glutathione, compound glycyrrhizin, polyene phosphatidylcholine. Three weeks later, the patient's symptoms disappeared, her liver function returned to normal limits and she was discharged.

  • Zhang Yi′nan, Li Xinchen, Shi Weizhong, Zhang Li, Li Guoqing, Zhao Zhigang
    Adverse Drug Reactions Journal. 2025, 27(6): 348-355. https://doi.org/10.3760/cma.j.cn114015-20240715-00580
    Objective To investigate the awareness of medical staff on pharmacovigilance and the current situation of the construction of pharmacovigilance system in medical institutions. Methods A self-designed questionnaire was sent to medical institutions in China through Professional Committee on Pharmacovigilance Research, China Society for Drug Regulation in the form of Wechat, and medical staff participated voluntarily. The contents of the questionnaire included 23 questions in 4 dimensions, including the basic information of the respondents, their understanding of the concept and regulations of pharmacovigilance, the management of pharmacovigilance, and the reporting and feedback of adverse drug reactions(ADRs)/events in their medical institutions. The survey time was from August 18, 2023 to October 18, 2023. The data from the questionnaire were analyzed descriptively. Results The collected questionnaires were from medical institutions in 31 provinces, autonomous regions, and municipalities directly under the central government, with a total of over 100 questionnaires collected in each region. A total of 10 991 medical staff participated in the survey, including 5 504 pharmacists, 2 120 doctors, and 3 367 nurses. Among them, 10 131 (92.18%) respondents had heard of pharmacovigilance, 4 511 (41.04%) had participated in pharmacovigilance-related works, 9 368 respondents (86.41%) answered that the ADRs monitoring and management system had been established in medical institutions where they worked, 8 186 respondents (75.51%) answered that leading group for pharmacovigilance (including ADRs monitoring) had been set up in the medical institutions where they worked, 8 605 respondents (79.37%) answered that the pharmacovigilance works was managed by special personnel in the institutions where they worked, 7 859 (72.49%) answered that there were liaison officers in the clinical departments where they worked, 6 043 (55.74%) answered that the individuals would be rewarded for reporting ADRs, 4 809 (44.36%) answered that pharmacovigilance had been included in the daily works and assessment indicators of the departments, and 5 351 (49.36%) answered that reports of ADRs were reviewed by special personnel. Active reporting by medical staff was the main collection channel of ADRs, 3 391 (31.28%) answered they had actively captured ADRs from the hospital information system, and 7 728 (71.28%) answered they had reported ADRs through the hospital information system, 10 061 (92.81%) answered that the monitoring results of ADRs would be regularly fed back in the hospitals where they worked, and 6 239 (57.55%) answered that regular training on pharmacovigilance for all medical staff would be provided in the institutions where they worked. Conclusions Medical staff have generally heard of pharmacovigilance and are aware of the national pharmacovigilance system, but they still have insufficient understanding of the concept and regulations of pharmacovigilance. The degree of participating in pharmacovigilance works of medical staff in different regions are different. The monitoring and management of ADRs could be paid attention to in the most medical institutions, but the degree of improvement of pharmacovigilance system in different levels of medical institutions is different.
  • Zhao Lijuan, Yan Baoqing, Shao Jianzhou, Liu Yupeng
    Adverse Drug Reactions Journal. 2025, 27(6): 380-382. https://doi.org/10.3760/cma.j.cn114015-20240926-00063
    A 75-year-old female patient with postoperative colon cancer received fruquintinib (5 mg once daily, 3 weeks on and 1 week off per 4 week cycle). The patient had normal blood pressure in the past, and approximately one week after medication, she developed hypertension with systolic blood pressure 180-190 mmHg and unknown diastolic pressure. The patient′s blood pressure was with adequate control after self-administration of nifedipine sustained-release tablets twice (20 mg/dose). After 3 weeks of fruquintinib treatment, bilateral lower limb edema occurred in the patient, leading to a 1 week drug discontinuation. Upon resuming the medication for 1 day, the patient suddenly developed dyspnea and loss of consciousness. Chest CT revealed signs of heart failure. Laboratory tests showed high-sensitivity cardiac troponin I (hs-cTnI) 0.27 μg/L, creatine kinase (CK)-MB 7.13 μg/L, myoglobin 132.88 μg/L, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) 4 039.8 ng/L. Fruquintinib was discontinued, and the patient received myocardial nutritional support, diuretics, anticoagulants, hepatoprotective agents, and potassium supplementation, etc. On day 2, the patient regained consciousness with hs-cTnI 0.28 μg/L, CK-MB 4.63 μg/L, myoglobin 34.25 μg/L, and NT-proBNP 10 181.3 ng/L. Antiplatelet therapy, diuretics, lipid-lowering agents, and antihypertensive treatment were initiated. On day 3, color doppler echocardiography confirmed myocardial infarction complicated by heart failure. Fruquintinib-induced acute non-ST-segment elevation myocardial infarction with acute heart failure was considered. On day 6 of fruquintinib discontinuation, NT-proBNP decreased to 295.8 ng/L, and all laboratory test parameters normalized on day 9. One month later, repeated tests showed no abnormalities in the myocardial enzyme.
  • 论著
    Mao Yudan;Zhang Yantao;Zhai Suodi*
    . 2008, 10(1): 0-0.

    Objective:To develop a mobile pharmacy service system(MPSS)for enhancement of medication compliance and safety to patients.Methods: A mobil pharmacy service system (MPSS) was formed through developing the pharmacy service database, applied database system, and transmitting and receiving installation for short message. One hundred patients (57 men, 43 women, median age 55 years) discharged from hospitle while receiving continued drug therapy entered the pilot trials of the MPSS. Of the 100 patients, 60 suffered from hematological disorders, 24 osteopathy, and 16 dermopathy. The short message containing the information of administration, dosage, precaution, and adverse reactions of drugs were transmited to the patient's mobile through the MPSS for the medication instruction and communication between medical staffs and patients.Results: Each patient received the service time of 12.06 days and the instruction of 3.52 different agents on average. The investigation and feedback from the patients showed that the overall evaluation to the MPSS was good, and the quality of service was scored 92.3. Conclusion: The MPSS has the advantages of convience, rapidness, reliance, and higher coverage. It is of practical value to medication compliance and safety to patients.

  • Qiu Rui, Luo Mingying, Zheng Gaofeng, Li Jinlan
    Adverse Drug Reactions Journal. 2025, 27(6): 377-379. https://doi.org/10.3760/cma.j.cn114015-20241010-00084
    A 77-year-old male patient with lung adenocarcinoma received targeted therapy with savolitinib 400 mg orally once daily. Eleven days later, he developed fever and chest CT scan revealed interstitial changes in both lungs, which were improved after savolitinib withdrawal and glucocorticoids treatment. The patient was given the same dose of savolitinib orally again. Three days later, the patient′s cough and shortness of breath worsened. Laboratory tests showed percentage of neutrophils 90% and procalcitonin 1.56 μg/L. Chest CT scan indicated interstitial changes in the right lung. The patient was diagnosed with interstitial pneumonia companied with infection, which was considered to be related to savolitinib. Savolitinib was discontinued and glucocorticoids and anti-infective therapy were given. After 14 days, the patient′s cough and shortness of breath were improved, laboratory tests showed percentage of  neutrophils 89% and procalcitonin 0.18 μg/L.
  • Zhao Manman, Jiang Lijun, Zhao Jing, Jiang Hua, Huang Ying, Wen Hairuo, Zhou Xiaobing
    Adverse Drug Reactions Journal. 2025, 27(5): 274-280. https://doi.org/10.3760/cma.j.cn114015-20240809-00707
    Objective To explore the biodistribution characteristics of mixed activated killer (MAK) immune cells in immunodeficient mice after administration. Methods Ninety-six immune immunodeficient (NOG) mice (half male and half female) were equally divided into MAK cell group and solvent control group. The MAK cell group mice were injected with DiR-labeled MAK cells via the tail vein, while those in the solvent control group were injected with an equal amount of solvent via the tail vein. The number of MAK cells in the peripheral blood of mice was detected using a flow cytometry at 11 time points from 15 minutes to 84 days after administration. The distribution of MAK cells in mice was measured using in vivo bioluminescence imaging at 18 time points from 5 minutes to 84 days after administration. And at 8 time points from 3 hours to 84 days after administration, the heart, liver, spleen, lungs, kidneys, brain, stomach, duodenum, colon, bone marrow, fat, skeletal muscle, testes/uterus, epididymis/ovary, and blood were collected from corresponding mice. The DNA levels of MAK cells in blood and various organs of these mice were detected using fluorescence real time quantitative polymerase chain reaction (qPCR) method. Results The flow cytometry results showed that MAK cells could be detected in the peripheral blood of mice 15 minutes after administration, and the highest number of MAK cells in blood appeared during 3 hours to 1 day. By 14 days after administration, MAK cells were almost undetectable in peripheral blood of mice. In vivo bioluminescence imaging results showed that the fluorescence intensity of MAK cells in mice was strongest on days 1 and 2 after administration, and MAK cells were mostly distributed in the liver, spleen, lung, and leg bone of mouse. The qPCR detection results showed that MAK cells were mainly distributed in the spleen and lungs. High levels of MAK cell DNA amplification were observed in organs such as the spleen and lungs 28-56 days after administration, and a certain amount of MAK cell DNA could still be detected in organs of mice such as the spleen at 84 days. Conclusions After administration, MAK cells were mainly distributed in the spleen, lung, liver and other organs of NOG mice. From 28 to 56 days after administration, MAK cells are significantly activated and proliferate, and a certain amount of MAK cell DNA can still be detected in the spleen and other organs after 84 days in mice.
  • Guo Qing, Wu Yue
    Adverse Drug Reactions Journal. 2025, 27(6): 372-374. https://doi.org/10.3760/cma.j.cn114015-20240914-00047
    A 5-year-old male patient with congenital adrenal hyperplasia and 21-hydroxylase deficiency was treated with intervention, laser, left eye retinoblastoma resection, and retinal repositioning  surgery for left eye retinoblastoma at the age of 2 years and 3 months. At the age of 3 years and 4 months, the child underwent peritoneal tumor resection and partial adrenalectomy for adrenal neuroblastoma. Hydrocortisone 2.5 mg thrice daily orally and fludrocortisone 0.02 mg once daily orally were given regularly for a long time after surgery. Three years after the resection of the left eye retinoblastoma, the tumor recurred and the child underwent another resection and retinal retinal repositioning surgery for the left eye retino- blastoma. After the surgery, he received a combination chemotherapy of vincristine (1.06 mg by intravenous infusion on day 1), etoposide (105 mg by intravenous infusion on days 1-2), and carboplatin (395 mg by intravenous infusion on day 1) (VEC) for left retinoblastoma, with 28 days as one treatment cycle. After 2 days of medication, the child experienced nausea, vomiting, and abdominal discomfort. After 5 days, he developed pale complexion, nausea, vomiting, and poor mental state. Laboratory tests showed cortisol 29.6 μg/L, blood sodium 133 mmol/L, and random blood glucose 2.4 mmol/L. Adrenal crisis caused by VEC chemotherapy was considered. Oral hydrocortisone was stopped and switch to intravenous infusion of hydrocortisone 10 mg thrice daily, while symptomatic treatment such as sodium supplementation was given. After 2 days, the symptoms of the child were improved. After 7 days, the child had no nausea or vomiting, cortisol increased to 291.0 μg/L, and blood sodium and blood glucose returned to normal.
  • Zhi Dongli, He Wei, Zhu Cui
    Adverse Drug Reactions Journal. 2025, 27(6): 375-377. https://doi.org/10.3760/cma.j.cn114015-20241008-00080
    A 9 years and 8 months old girl was prescribed procaterol hydrochloride oral solution (procaterol) 25 μg (5 ml) twice daily for cough and asthma. The girl mistakenly took 25 ml of procaterol because her grandmother thought it was 25 μg. After 30 minutes, the girl developed restlessness, shortness of breath, trembling hands, and vomiting. Physical examination showed heart rate 148 beats/min, cardiac auscultation showed arrhythmia, electrocardiogram showed frequent ventricular premature beat, and labora- tory tests showed blood potassium 2.5 mmol/L. Procaterol poisoning was considered. Oxygen inhalation, electrocardiographic monitoring, metoprolol tartrate tablets 25 mg orally, and symptomatic and supportive treatments such as coenzyme A, adenosine triphosphate, and potassium chloride, were given immediately. Two hours alater, the child′s restlessness disappeared and shortness of breath was improved; the electro- cardiogram reexamination showed no ventricular premature beat. Ten hours later, the heart rate returns to normal. The next day, her blood potassium level returned to normal.
  • Zhu Xiangyu, Sun Mingyue, Liu Yuan, Zhao Zhikun, Jiang Ping, Pan Weiwei, Wang Ziyu, Zhang Yajuan, Fu Jing, Yang Haichen, Du Yeping, Zhang Jinsong, Shi Yan
    Adverse Drug Reactions Journal. 2025, 27(6): 369-371. https://doi.org/10.3760/cma.j.cn114015-20240701-00506
    A 36-year-old male developed unconsciousness and no response to voice stimuli after taking approximately 2 050 mg felodipine (the specific time was unknown). Two hours later, he was sent to the department of emergency by his family and admitted to the hospital. His vital signs showed body temperature 35.1 ℃, pulse 148 times/min, respiration 32 times/min, and blood pressure 65/34 mmHg. Acute drug poisoning, acute toxic cardiomyopathy, acute toxic shock, acute type Ⅱ respiratory failure, acute toxic encephalopathy, and acute renal failure were diagnosed based on the patient′s clinical manifestations combined with laboratory tests results, cardiac ultrasound, chest and abdominal CT scans. Endotracheal intubation connected to a ventilator for invasive assisted ventilation, pressure boosting, and fluid resuscitation were given. At the same time, repeated gastric lavage and enema were performed to remove toxins. Blood perfusion was intermittently and repeatedly administered, and continuous renal replacement therapy was used. The blood concentration of felodipine was 1 298 μg/L at 2 hours after admission, and cardiac arrest occurred at 4 hours. Venous-arterial extracorporeal membrane oxygenation (V-A ECMO) treatment was administered immediately. After 48 hours of ECMO operation, sedatives were discontinued and the patient′s consciousness was improved after 4 hours. On the 5th day of ECMO treatment, his heart rate was 72 beats per minute, and blood pressure was 127/65 mmHg. The blood concentration of felodipine decreased to 2 μg/L. The patient′s vital signs were significantly improved and ECMO supportive treatment was withdrawn. After 26 days of hospitalization, the patient recovered and was discharged.
  • Tuo Mingfu, Di Xiaoyuan, Yang Kun, Tang Caie, Du Yan, He Hongying
    Adverse Drug Reactions Journal. 2025, 27(6): 332-338. https://doi.org/10.3760/cma.j.cn114015-20241210-00196
    Objective To systematically evaluate the incidence and risk factors of acute kidney injury (AKI) induced by vancomycin in pediatric patients. Methods Databases of PubMed, Embase, The Cochrane Library, Web of Science, CNKI, Wanfang, VIP, Chinese Biomedical Database (CBM) were searched and articles about the risk factors of AKI induced by vancomycin in pediatric patients from inception to June 2024 were collected. Quality assessment was performed using the Newcastle-Ottawa Scale (NOS) for the included studies. Meta-analysis of the data for relevant exposure factors extracted from the included literature was conducted using Rev Man 5.4. The strength of association between the exposure factors and AKI was expressed using the odds ratio (OR) and its 95% confidence interval (CI). Results A total of 13  studies were entered, involving 11 073 patients. Of them, 1 388 patients were in AKI group and 9 685 patients in non-AKI group. The incidence of AKI was 12.53%, ranging from 4.62% to 27.07%. The quality evaluation results showed that the 13 documents were all of high-quality (NOS score ≥7 points). Meta-analysis showed that admission to intensive care unit (ICU) (OR=2.39, 95%CI: 1.59-3.59, P<0.001), vancomycin using time ≥7 d (OR=2.19, 95%CI: 1.44-3.34,P=0.003), vancomycin steady-state trough concentration ≥15 mg/L (OR=2.98, 95%CI: 2.22-4.01, P<0.001), combined with nephrotoxic drugs ≥2 kinds (OR=2.92, 95%CI=1.84-4.64, P<0.001), combined with piperacillin sodium and tazobactam sodium (OR=2.71, 95%CI: 1.72- 4.27, P<0.001), combined with carbapenem (OR=2.36, 95%CI: 1.36-4.10, P=0.002), combined with aminoglycosides (OR=1.78, 95%CI: 1.35-2.35, P<0.001), combined with loop diuretics (OR=3.16, 95%CI: 2.36- 4.23, P<0.001), combined with amphotericin B (OR=2.26, 95%CI: 1.35-3.79, P=0.002), combined with contrast medium (OR=2.34, 95%CI: 1.04-5.25, P=0.040), and combined with aciclovir (OR=1.74, 95%CI: 1.04-2.84, P=0.030) were all risk factors of AKI induced by vancomycin in pediatric patients. Conclusions The incidence of vancomycin-related AKI in pediatric patients was 12.53%. Admission to ICU, vancomycin trough concentration ≥15 mg/L, medication time ≥7 d, and concomitant use of ≥2 nephrotoxic drugs and etc.were risk factors of vancomycin-related AKI.
  • Wen Jing, Qin Jianwei, Jiang Weihao, Xu Shitian
    Adverse Drug Reactions Journal. 2025, 27(6): 356-361. https://doi.org/10.3760/cma.j.cn114015-20241108-00138
    The use of CD20 monoclonal antibody in the treatment of children with refractory nephrotic syndrome (RNS) is a novel drug therapy in recent years. Some CD20 monoclonal antibodies have positive efficacy and few adverse reactions, which can reduce the use of hormone drugs and immunosuppressants to a certain extent. However, the treatment of nephrotic syndrome is off-label, and the application time in clinic is not long, especially for children′s RNS, and more high-quality clinical studies are still needed for long-term efficacy and safety. The application and safety research progress of CD20 monoclonal antibody (including rituximab, ofatumumab, obinutuzumab, etc.) in the treatment of children with RNS from the aspects of mechanism of action, clinical application, pharmacokinetic characteristics, adverse reactions monitoring, and prevention are reviewed in this article, so as to provide reference for rational and safe clinical use.
  • Niu Yunhe, Bao Ying, Huang Huimei, Li Zhijuan, Zhang Min, Wang Ying, Liang Nan, Wang Yanping, Yang Nan
    Adverse Drug Reactions Journal. 2025, 27(6): 325-331. https://doi.org/10.3760/cma.j.cn114015-20241018-00099
    Objective To observe the efficacy and safety of adrenocorticotropic hormone (ACTH) therapy in children with steroid dependent nephrotic syndrome (SDNS)/frequently relapsed nephrotic syndrome (FRNS). Methods The clinical data of children with SDNS/FRNS who received treatment with prednisone acetate tablets were retrospectively collected from June 2019 to June 2023 in the Nephrology Department of Xi′an Children′s Hospital. The children were divided into glucocorticoid+ACTH group and glucocorticoid group, according to whether ACTH was used or not. The differences in cortisol, total cholesterol and 24 hour urinary protein quantity between 2 groups of children at baseline and follow-up endpoints were compared, and the effectiveness (the proportion of no recurrence and discontinuation of glucocorticoid) and occurrence of adverse reactions were evaluated. Results A total of 39 patients with SDNS/FRNS were included in this study, with 21 cases in the glucocorticoid+ACTH group and 18 cases in the glucocorticoid group. Among the 39 children, there were 33 cases of SDNS and 6 cases of FRNS, respectively. The proportion of baseline low cortisol levels was 76.9% (30/39). The proportion of cortisol levels returning to normal after ACTH treatment in the glucocorticoid+ACTH group was 76.2% (16/21). The baseline and follow-up endpoint for cortisol levels in the glucocorticoid+ACTH group were 28.0(19.8, 51.5) μg/L and 79.9(58.9, 113.0) μg/L, respectively. The baseline and follow-up endpoint for cortisol levels in the glucocorticoid group were 21.0(15.8, 37.4) μg/L and 25.3(18.2, 51.4) μg/L, respectively. In the 2 groups of cortisol levels, there was statistically significant difference in the interaction effect between time and group (Wald χ2=11.595, P=0.001), there was a statistically significant difference at the follow-up endpoint between the 2 groups (Wald χ2=19.462, P<0.001), and the difference was statistically significant in the time effect of the glucocorticoid+ACTH group (Wald χ2=21.100, P<0.001). The baseline and follow-up endpoint for total cholesterol in the glucocorticoid+ACTH group were 4.95(4.23, 5.26) mmol/L and 4.38(4.04, 5.24) mmol/L, respectively. The baseline and follow-up endpoint for total cholesterol in the glucocorticoid group were 4.80 (4.17, 5.28) mmol/L and 5.74 (5.04, 6.88) mmol/L, respectively. In the 2 groups of total cholesterol, there was statistically significant difference in the interaction effect between time and group (Wald χ2=9.842, P=0.002), there was statistically significant difference at the follow-up endpoint between the 2 groups(Wald χ2=12.187,P<0.001), the difference was statistically significant between the 2 groups in the time effect at baseline and the follow-up endpoint (glucocorticoid+ACTH group: Wald χ2=6.488, glucocorticoid group: Wald χ2=7.112; all P<0.05). The baseline and follow-up endpoint for 24 hour urinary protein quantity in the glucocorticoid+ACTH group were 115(105,128) mg/d and 121(113,128) mg/d, respectively. The baseline and follow-up endpoint for 24 hour urinary protein quantity in the glucocorticoid group were 118(113,125) mg/d and 138(119,2 100) mg/d, respectively. In the 2 groups of 24 hour urinary protein quantity, there was statistically significant difference in the interaction effect between time and group (Wald χ2=7.743, P=0.005), there was statistically significant difference at the follow-up endpoint between the 2 groups (Wald χ2=7.779, P=0.005), and the difference was statistically significant in the time effect of the glucocorticoid group (Wald χ2=13.331, P<0.001). The proportion of no recurrence (17/21) and discontinuation of oral glucocorticoid (16/21) in the glucocorticoid+ACTH group were higher than those in the glucocorticoid group (the proportion were both 6/18), and the differences between the 2 groups were statistically significant (the chi square values were 9.084 and 7.240, respectively; all P<0.01). No adverse reactions occurred in the glucocorticoid group. The incidence of adverse reactions in the glucocorticoid+ACTH group was 14.3% (3/21), of which 2 cases developed generalized urticaria and 1 case developed hypertension. Conclusions ACTH has a good efficacy and safety in children with SDNS/FRNS. The results of this study need to be further validated by increasing the sample size and conducting multicenter studies.