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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.
  • 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.
  • Adverse Drug Reactions Journal. 2020, 22(8): 496-496.
  • 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.
  • 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.
  • 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.
  • Liu Yinyin, Li Fan, Fan Zhaopu, Huo Yalan
    Adverse Drug Reactions Journal. 2020, 22(7): 424-425.
    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.
  • 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.
  • 指南与共识
    . 2014, 16(6): 321-6.
  • 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.
  • . 2017, 19(1): 76-77.
  • 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.
  • 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.
  • . 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).
  • 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.
  • Wu Jianbiao, Yu Li
    Adverse Drug Reactions Journal. 2020, 22(5): 311-312.
    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.
  • Lu Jiejiu, Huang Guangming, Lyu Chunle, Liu Taotao
    Adverse Drug Reactions Journal. 2021, 23(5): 235-240.
    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.
  • 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.
    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.
  • Sun Bo, Liu Xun, Zhang Erfeng, Ma Huanqing
    Adverse Drug Reactions Journal. 2021, 23(11): 612-614.
    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.
  • Shu Wenlin, Chen Shuifang
    Adverse Drug Reactions Journal. 2020, 22(12): 701-702.
    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.
  • Gu Ling, Bao Wenyi, Qian Jian
    Adverse Drug Reactions Journal. 2021, 23(2): 108-109.
    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.
  • Center for Drug Reevaluation, National Medical Products Administration; Chinese Pharmacists Association et al
    Adverse Drug Reactions Journal. 2022, 24(6): 284-294.
    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.
  • 相互作用
    . 2006, 8(1): 33-38.
  • 安全合理用药
    . 2007, 9(1): 28-32.
  • . 2017, 19(3): 163.
  • Song Jiawei, Wang Lu, Chen Huijuan, Liu Li, Wang Qiangqiang, Wu Wei
    Adverse Drug Reactions Journal. 2021, 23(3): 165-166.
    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.
  • Cai Yue, Wang Yanchun, Zhou Xiaohui, Zhu Xiaoran, Tian Dongdong, Dong Zhanjun
    Adverse Drug Reactions Journal. 2022, 24(12): 664-666.
    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.
  • Zhao Yanhua
    Adverse Drug Reactions Journal. 2022, 24(1): 49-51.
    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.
  • . 2017, 19(6): 409.
  • 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.
  • 中毒救治
    . 2006, 8(5): 368-369.
  • 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.

  • 安全用药
    . 2006, 8(4): 276-279.
  • 安全用药
    . 2006, 8(4): 279-283.
  • 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.
  • 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.
    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.
  • Zhang Kai, Tian Yingchao, Zeng Bingqing, Tang Zhihui
    Adverse Drug Reactions Journal. 2020, 22(10): 601-602.
    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.
  • 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.
    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.
  • . 2016, 18(6): 401.
  • 综述
    . 2005, 7(2): 81-90.
  • 安全用药
    . 2003, 5(4): 241-245.
  • Lin Zhiqiang, Zhang Qingquan, Chen Tingting
    Adverse Drug Reactions Journal. 2020, 22(7): 409-415.
    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.
  • 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.

  • Si Jigang, Zhou Jian, Zhao Qun, Sun Min
    Adverse Drug Reactions Journal. 2020, 22(10): 587-588.
    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.
  • 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.

  • Lin Dan, Zhao Xiu, Jiang Hao
    Adverse Drug Reactions Journal. 2020, 22(11): 646-647.
    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.
  • Gao Feimeng, Song Zhihui
    Adverse Drug Reactions Journal. 2020, 22(6): 381-382.
    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.
  • 药物滥用
    . 2005, 7(4): 272-274.
  • Liu Qun, Jin Wenwen, Geng Ning, Lin Zhonghua, Xin Yongning
    Adverse Drug Reactions Journal. 2020, 22(8): 484-485.
    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.
  • Pan Bobo, Xu Xiaohong, Lu Xiaoyan, Huang Yuena, Zhong Han, Dai Youqin
    Adverse Drug Reactions Journal. 2021, 23(12): 661-663.
    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.
  • 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.

  • . 2017, 19(6): 403.
  • Han Maozhi, Li Shasha, Li Jing, Li Xianchao, Gao Linlin, Lu Yan, Zhou Ziyu
    Adverse Drug Reactions Journal. 2020, 22(6): 375-376.
    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.
  • 安全用药
    . 2006, 8(5): 363-367.
  • Adverse Drug Reactions Journal. 2020, 22(5): 273-279.
     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).
  • 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.
  • 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.
  • Mao Min, Liao Mingyan, Mao Jian, Wang Li
    Adverse Drug Reactions Journal. 2020, 22(12): 711-712.
    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.
  • Jiang Kun, Song Linjing, You Lina
    Adverse Drug Reactions Journal. 2020, 22(9): 529-530.
    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.
  • Wang Chunhui, Wu Wei, Li Xiaoyu, Lyu Qianzhou, Xu Bei
    Adverse Drug Reactions Journal. 2021, 23(3): 158-160.
    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.
  • Zhou Nan, Guo Guiping, Mao Lichao, Guan Yue
    Adverse Drug Reactions Journal. 2020, 22(10): 597-598.
    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.
  • . 2016, 18(1): 4.
  • Wang Zhizhou, Cheng Hongqin, Bai Xiangrong, Jin Ying, Jiang Dechun, Zhang Shengpeng
    Adverse Drug Reactions Journal. 2020, 22(6): 379-380.
    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.
  • Wu Wei, Chu Binbin, Liang Linchun
    Adverse Drug Reactions Journal. 2020, 22(10): 599-600.
    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.
  • Yan Xuelian, Huang Qian, Ge Nan, Sun Wenjuan, Zhang Bo, Wang Kai
    Adverse Drug Reactions Journal. 2020, 22(11): 631-637.
    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.
  • 安全用药
    . 2003, 5(6): 381-383.
  • Wei Juanjuan, Lin Yang, Shi Xiujin
    Adverse Drug Reactions Journal. 2021, 23(2): 63-68.
    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.
  • 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.
  • 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.
  • Tian Danxing
    Adverse Drug Reactions Journal. 2022, 24(10): 554-556.
    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.
  • 安全用药
    . 2004, 6(1): 27-31.
  • Adverse Drug Reactions Journal. 2020, 22(3): 188-193.
    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。
  • 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.
  • Liu Jiancheng, Ma Xin, Chen Zhesi, Ling Zesha, Wang Wenchun
    Adverse Drug Reactions Journal. 2021, 23(1): 41-42.
    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.
  • 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.
  • 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.
  • Ma Shuangshuang, Xu Yunshan, Shen Wei
    Adverse Drug Reactions Journal. 2020, 22(8): 492-493.
     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.
  • Sun Lu, Zhao Huanyu
    . 2017, 19(2): 84-88.
  • 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.
  • 国外信息
    . 2005, 7(2): 150-154.
  • 综述
    . 2002, 4(4): 217-220.
  • 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.
  • 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.
  • Adverse Drug Reactions Journal. 2020, 22(3): 130-138.
  • Gao Yiling, Zhu Minghui, Tang Qiaoyun, Ni Tong, Wang Lin, Ma Jing
    Adverse Drug Reactions Journal. 2021, 23(7): 387-389.
    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.
  • Xing Man, Shi Shiqiang, Gao Jing, Wang Na
    Adverse Drug Reactions Journal. 2020, 22(4): 270-271.
    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.
  • 药害史
    . 2010, 12(5): 335-3.
  • Liu Lanlan, Zhao Juanjuan
    Adverse Drug Reactions Journal. 2020, 22(5): 317-318.
    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.
  • 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.
  • 学术研讨
    . 2006, 8(5): 329-331.
  • 安全用药
    . 2005, 7(2): 108-111.
  • 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.
  • Liu fang, Zhang Xiaole, Zhu Zhu
  • 综述
    . 2007, 9(1): 1-6.
  • 安全合理用药
    . 2007, 9(1): 32-35.
  • 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.
  • Sun Yue, Liu Jia, Liao Qingchi
    Adverse Drug Reactions Journal. 2020, 22(4): 266-267.
    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.
  • 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.
  • 抗菌药应用
    . 2005, 7(2): 118-124.
  • 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.

  • Liu Xun, Sun Bo, Zhang Huizhi, Zhang Ying, Zhao Baohong
    Adverse Drug Reactions Journal. 2020, 22(10): 583-584.
    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.
  • Wang Le, Yuan Haiyan, Ye Xi
    Adverse Drug Reactions Journal. 2022, 24(7): 373-375.
    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.
  • 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
  • . 2016, 18(1): 2.
  • 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.
  • 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
    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.
  • 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.
  • 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.
  • 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).
  • 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
    . 2000, 2(3): 143-148.
  • 监测简报
    . 2004, 6(1): 50-52.
  • Zhong Zhilei, Chen Qiuyu, Ma Ruilan, Qi Qiucheng, Li Jiaxuan, Yang Jingsi
    Adverse Drug Reactions Journal. 2021, 23(7): 337-341.
    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.
  • Zhao Xue, Li Fan, Zhang Yanli, Zhang Xiao, Cao Junling
    Adverse Drug Reactions Journal. 2022, 24(3): 147-149.
    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.
  • 中毒救治
    . 2007, 9(1): 43-45.
  • 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.
  • 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.
  • 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.
  • . 2016, 18(4): 241.
  • 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.
  • Wang Chunhui, Li Qianwen, Wu Wei, Li Xiaoyu, Lyu Qianzhou
    Adverse Drug Reactions Journal. 2020, 22(10): 595-596.
    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 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.
  • 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.
  • . 2017, 19(4): 241.
  • 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.
  • 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).
  • 相互作用
    . 2007, 9(2): 112-116.
  • 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.
  • 读者·作者·编者
    . 2006, 8(4): 312-314.
  • 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.
  • 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.
    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.
  • 综述
    . 1999, 1(1): 18-21.
  • Wang Yu, Li Jia, Pan Yunyan, Zheng Yifan, Chen Pan, Chen Jie
    Adverse Drug Reactions Journal. 2022, 24(7): 347-352.
    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.
  • 综述
    . 2000, 2(2): 76-80.
  • 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.
  • . 2017, 19(1): 6-9.
  • Chen Huiying, Xu Daliang, Zhu Ying
    Adverse Drug Reactions Journal. 2022, 24(7): 378-380.
    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.
  • . 2017, 19(3): 161.
  • 药害史
    . 2006, 8(3): 217-220.
  • 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.
    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.
  • 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.
  • 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.
  • 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.
  • 安全用药
    . 2006, 8(2): 113-116.
  • . 2015, 17(3): 161.
  • Adverse Drug Reactions Journal. 2021, 23(4): 224-224.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • Zhang Hongmei, Guo Qiushi, Tian Xu, Sun Lirui
    Adverse Drug Reactions Journal. 2022, 24(7): 376-377.
    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.
  • 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.
    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.
  • 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.
  • 安全用药
    . 2006, 8(3): 188-191.
  • 学术研讨
    . 2006, 8(5): 326-329.
  • . 2017, 19(5): 323.
  • Liu Yonghong, Chen Xiaoping, Shuai Ying
    Adverse Drug Reactions Journal. 2021, 23(9): 493-494.
    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.
  • Ni Chunyan
    Adverse Drug Reactions Journal. 2022, 24(3): 144-146.
    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.
  • 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.
    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.
  • 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.
  • 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.

  • 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.
  • 安全用药
    . 2004, 6(3): 163-166.
  • 安全用药
    . 2004, 6(6): 387-392.
  • 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.
  • 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
    . 2003, 5(2): 95-97.
  • 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.
  • 安全用药
    . 2004, 6(5): 312-315.
  • Tang Jie, Luo Li, Wang Rui, Liu Zhihui
    Adverse Drug Reactions Journal. 2020, 22(7): 434-435.
    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.
  • 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
  • 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.

  • Wang Qingyu, Chen Zhuang
    Adverse Drug Reactions Journal. 2023, 25(8): 497-503.
    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.
  • 药物评介
    . 2006, 8(6): 463-466.
  • 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.

  • 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.

  • Du Wenjin, Zhu Rongfei
    Adverse Drug Reactions Journal. 2022, 24(10): 540-545.
    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.
  • 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(3): 173-176.
  • 安全用药
    . 2005, 7(1): 29-31.
  • . 2016, 18(3): 161.
  • 安全合理用药
    . 2007, 9(2): 105-107.
  • 安全用药
    . 2005, 7(5): 340-345.
  • Feng Xin, Gai Di
    . 2017, 19(5): 321.
  • 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.
  • 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.
  • . 2017, 19(1): 3-5.
  • Zhang Lingli
    . 2016, 18(2): 81.
  • 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.
  • 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.
  • 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.

  • 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.
  • 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.
  • 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 .
  • 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.
  • 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.
  • Li Tianzuo
    Adverse Drug Reactions Journal. 2020, 22(5): 280-282.
    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.
  • Liu Ting, Fan Xiaohong, Zeng Yueping, Qin Yan, Ai Sanxi, Li Xuemei
    Adverse Drug Reactions Journal. 2022, 24(6): 332-334.
    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.
  • Rui Min, Zhu Zhonghua
    Adverse Drug Reactions Journal. 2023, 25(1): 53-55.
    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.
  • Wang Shuo, Cai Haodong, Mei Dan
    Adverse Drug Reactions Journal. 2021, 23(7): 370-376.
    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.
  • Tang Jinyan, Lu Peipei, Yang Hui, Qian Hui, Xi Junzuan, Shen Jinhua
    Adverse Drug Reactions Journal. 2021, 23(6): 324-325.
    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.
  • 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.
  • 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
    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.
  • Feng Yanhua, Xu Zhenhua
    Adverse Drug Reactions Journal. 2021, 23(12): 651-652.
    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.
  • 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.
  • 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.
  • 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
    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.
  • Deng Meiyu, Yu Xuhong, Zhang Linghui, Chen Ling
    Adverse Drug Reactions Journal. 2022, 24(12): 641-646.
    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.
  • 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.
  • 学术讨论
    . 2000, 2(2): 113-118.
  • 安全用药
    . 2003, 5(1): 21-23.
  • 中毒救治
    . 2006, 8(3): 202-204.
  • 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.
  • 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.
  • 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.
  • 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.
  • Li Qin, Zhuo Ga, Jin Meiling, Ye Xiaofen
    Adverse Drug Reactions Journal. 2021, 23(6): 317-318.
    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.
  • 安全用药
    . 2005, 7(5): 345-348.
  • 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
    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
    . 2004, 6(2): 97-101.
  • 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.
  • 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.

  • Gao Lingyan, Zhai Dongdong, Ge Sang, Liu Hua
    Adverse Drug Reactions Journal. 2020, 22(12): 695-696.
    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.
  • ADE简报
    . 2001, 3(3): 201-201.
  • 综述
    . 2005, 7(6): 401-407.
  • 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
    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.
  • 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
    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.
  • 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.
  • 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.
  • . 2016, 18(1): 52.
  • Cai Haodong
    Adverse Drug Reactions Journal. 2020, 22(2): 95-102.
    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.
  • 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.

    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.

  • 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.

  • 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.
  • Liu Yanru, He Yanju
    Adverse Drug Reactions Journal. 2021, 23(10): 544-545.
    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.
  • 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.
    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.
  • 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.
    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.
  • 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.
  • 综合报道
    . 2001, 3(3): 184-186.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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
  • Yu Lihong, Zhao Ting, Ma Wenming
    Adverse Drug Reactions Journal. 2022, 24(7): 387-389.
    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.
  • 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.

  • Zeng Jiawei, Chen Xiao