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2022, 24(9)
HighLights More»   
· Discussing drug-induced neurological disorders on World Patient Safety Day
· Analysis on reports of medication errors on proton pump inhibitors in National Monitoring Network for Clinical Safe Medication in 2020
· Preventive effect of angiotesion converting enzyme inhibitors/angiotensin receptor blockers and beta-blockers against trastuzumab-related cardiotoxicity in patients with breast cancer: a meta- analysis
· Clinical case analysis of extremely severe tirofiban?induced thrombocytopenia
· Survey and analysis of the awareness and application status of drugs used with caution in myasthenia gravis patients
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  Adverse Drug Reactions Journal--2022, 24 (9)   Published: 28 September 2022
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Discussing drug-induced neurological disorders on World Patient Safety Day Hot!
Song Haiqing
Adverse Drug Reactions Journal. 2022, 24 (9): 449-453. ;  doi: 10.3760/cma.j.cn114015-20220915-00848
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The theme of World Patient Safety Day 2022 is Medication Safety. Medication safety has become a hot issue in the field of life science research, and the adverse effects of drugs on the central nervous system have gradually attracted clinical attention. Common drug-induced neurological disorders include drug-induced epilepsy, drug-induced extrapyramidal disorders, drug-induced encephalopathy, drug-induced stroke, drug-induced visual impairment, drug-induced spinal cord injury, drug-induced sleep disorders, drug-induced cognitive dysfunction, drug-induced serotonin syndrome, and drug-induced peripheral neuropathy. The drugs that cause drug-induced neurological disorders mainly include antipsychotic drugs, antianxiety and antidepression drugs, anticonvulsant drugs, chemotherapy drugs, and some drugs for cardiovascular system diseases such as statins. The principles for treatment of suspected drug-induced neurological disorders include: (1) improving examination and clarifing diagnosis; (2) removing the causes and stopping or reducing the use of pathogenic drugs; (3) eliminating pathogenic drugs in the body; (4) giving symptomatic treatments and nutritional support.
Analysis on reports of medication errors on proton pump inhibitors in National Monitoring Network for Clinical Safe Medication in 2020 Hot!
Qiu Yujie, Wang Yuqin, Zhang Qingxia
Adverse Drug Reactions Journal. 2022, 24 (9): 454-461. ;  doi: 10.3760/cma.j.cn114015-20220321-00228
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Objective To analyze the occurrence of medication errors (MEs) and their influen- cing factors on proton pump inhibitors (PPIs) and to provide reference for the standard use of PPIs in clinic. Methods The ME reports on PPI-related MEs in the National Monitoring Network for Clinical Safe Medication (monitoring network) from January 1, 2020 to December 31, 2020, were collected and information of MEs including drugs involved, ME grading, error content, the persons who triggered and found the errors, and the factors that caused the errors were analyzed. Results A total of 593 PPI-related ME reports from 97-hospitals in 21 provinces and municipalities in China were collected in the monitoring network in 2020. A total of 593 patients were involved, including 358 males (60.4%) and 235 females (39.6%), aged from 1 to 99 years old with an average age of 53.7 years. In the 593 MEs, there were 418 (70.5%), 167 (28.2%), 7 (1.2%), and 1 (0.2%) MEs were graded as grade B, C, D, and E, respectively; a total of 6 kinds of PPIs were involved and 649 times of ME occurred, of which 177 times (27.2%) were related to omeprazole, 143 (22.0%) to rabeprazole, 135 (20.8%) to esomeprazole, 123 (19.0%) to pantoprazole, 66 (10.2%) to lansoprazole, and 5 (0.8%) to ilaprazole. Among the 593 patients, the medication indications for PPIs included prevention of stress mucosal injury in 303 patients (51.1%), gastroesophageal reflux disease in 91 patients (15.3%), peptic ulcer in 64 patients (10.8%), upper gastrointestinal bleeding in 25 patients (4.2%), helicobacter pylori infection eradication in 6 patients (1.0%), and non-steroidal anti-inflammatory drug-related ulcers in 6 patients (1.0%). There were 103 patients (17.4%) received PPIs without appropriate indications and 5 patients (0.8%) with 2 indications at the same time. The 593 ME reports involved a total of 609 times of ME content, and the wrong indication (16.9%, 103/609) ranked the first, followed by the wrong drug class (16.3%, 99/609) and the wrong medication frequency (14.0%, 85/609). Among the 593 MEs, 75.1% (445 MEs) were triggered by physician, 20.7% (123 MEs) by pharmacists, 2.5% (15 MEs) by nurse, 0.7% (4 MEs) by patients/family members, and 1.0% (6 MEs) by others; 418 MEs (70.5%) were detected and intercepted in time, of which 87.6% (366/418) were found by pharmacists, 8.1% (34/418) by nurses, and 4.3% (18/418) by patients/family members. The factors that caused MEs occurred 659 times in total, mainly including lack of knowledge/insufficient training (accounting for 50.8%, 335/659), fatigue (accounting for 18.4%, 121/659), and look alike/sound alike (accounting for 9.1%, 60/659). Conclusions The contents of PPIs-related MEs mainly include wrong indications, wrong drug class, and wrong medication frequency. MEs are mainly caused by physicians and mostly discovered and intercepted by pharmacists. Lack of knowledge/inadequate training is a major factor in causing MEs.
Preventive effect of angiotesion converting enzyme inhibitors/angiotensin receptor blockers and beta-blockers against trastuzumab-related cardiotoxicity in patients with breast cancer: a meta- analysis Hot!
Chen Can, Li Qianwen, Wang Chunhui, Pang Yushi, Li Xiaoyu
Adverse Drug Reactions Journal. 2022, 24 (9): 462-470. ;  doi: 10.3760/cma.j.cn114015-20220302-00167
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Objective To evaluate the preventive effect of angiotesion converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB) and beta-blockers against trastuzumab-related cardiotoxicity in patients with breast cancer. Methods Databases of PubMed, Embase, and Web of Science and Clinical were searched (up to February 28, 2022) and randomized controlled trials (RCTs) on ACEI/ARB or beta-blockers in preventing trastuzumab-related cardiotoxicity in female breast cancer patients, who were treated with trastuzumab containing regimens and without underlying cardiac diseases, were collected. Patients in the trial group were given intervention measures of ACEI, ARB, or beta-blockers while those in the control group were given placebo or no intervention. The primary outcome indicator was the change of left ventricular ejection fraction (LVEF) from baseline, and the secondary outcome indicators were the incidence of cardiotoxic events, the incidence of trastuzumab discontinuation, and the change of blood pressure. Random effects model in Revman 5.4 was used for meta-analysis, the effect sizes of enumeration data were the relative risk (RR) and its 95% confidence interval (CI), and those of measurement data were the mean difference (MD) and its 95%CI. Results A total of 4 RCTs and 844 patients were included in the analysis, including 520 patients in the trial group and 324 patients in the control group. The results of the meta-analysis showed that patients in the trial group treated with ACEI/ARB had a lower LVEF reduction (MD=1.37%, 95%CI: 0.49%-2.25%, P=0.002) and higher mean value of systolic blood pressure decrease (MD=-5.99-mmHg, 95%CI: -9.15--2.83-mmHg, P<0.001) than those in the control group; patients in the trial group treated with beta-blockers had a lower risk of trastuzumab discontinuation due to cardiotoxicity than those in the control group [14.4% (27/187) vs. 26.6% (49/184), RR=0.55, 95%CI: 0.36-0.84, P=0.006]; other outcome indicators including the risk of cardiotoxic events in the patients of the trial group treated with ACEI/ARB or beta-blockers were not significantly different from those in the control group (all P>0.05). Conclusion ACEI/ARB may have a certain preventive effect on trastuzumab-related LVEF reduction in breast cancer patients, but ACEI/ARB and beta-blockers could not reduce the risk of trastuzumab-related cardiotoxic events.
Clinical case analysis of extremely severe tirofiban?induced thrombocytopenia Hot!
Wang Li, Zhang Liping, Ren Yujiao, Wang Xianjun, Li Zhengrong
Adverse Drug Reactions Journal. 2022, 24 (9): 471-477. ;  doi: 10.3760/cma.j.cn114015-20220427-00368
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Objective To investigate the occurrence and clinical characteristics of extremely severe tirofiban-induced thrombocytopenia (TIT). Methods Patients who used tirofiban during hospitali- zation in Linyi people′s Hospital from March 2015 to September 2021 was screened through the hospital information system. The medical records of patients with extremely severe TIT after medication were collected and analyzed retrospectively. The patient data extracted from the medical records included gender, age, medication indication, comorbidities, tirofiban application, combined drugs, platelet count (PLT) before and after tirofiban use, thrombocytopenia onset time from the application of tirofiban, the time to minimum value of PLT from medication, and the clinical manifestations, intervention, and prognosis of TIT, etc. Results A total of 10-354 inpatients who used tirofiban during the set period were entered, of which 20 (0.19%) had extremely severe TIT. Among the 20 patients, 16 were male and 4 were female, aged 39-84 years with an average age of 66 years, 12 of which were ≥65 years. The medication indications of tirofiban were acute myocardial infarction in 8 patients, cerebral infarction in 5 patients, unstable angina pectoris in 4 patients, and post-operation of coronary artery bypass grafting, transient ischemic attacks, and post-operation of coronary- stent implantation in 1 patient respectively. The comorbidities included hypertension in 13 patients, diabetes mellitus in 4 patients, cerebral infarction in 3 patients, and New York Heart Association (NYHA) greater than or equal to class Ⅲ heart failure in 3 patients. Tirofiban was administered by continuous intravenous pumping for 1-48-hours. The combined drugs included aspirin enteric-coated tablets, clopidogrel tablets, ticagrelor tablets, heparin, low molecular weight heparin, alteplase, and plasmin. Five patients had symptoms of chills and shivers within 1-6 hours after treatment, 7 had oral mucosal bleeding, epistaxis, gingival bleeding, skin ecchymosis, ecchymosis on venipuncture sites, tarry stool, or bloody stool within 1-7 days after treatment, and 10-had no clinical symptoms. The median time from tirofiban application to the onset of PLT decrease and to the minimum value of PLT [(1-18)×109/L] were 12 (6, 20) and 18 (12, 22) hours, respectively, and the 2 kinds of time above were consistent in 13 patients. Tirofiban was discontinued in all patients after the diagnosis of extremely severe TIT, and treatments with glucocorticoids, human immunoglobulin, and platelet infusion were given. PLT recovered to (100-258)×109/L after 3-17 days (median time 4 days) of treatments in 18 patients. The other 2 patients developed tarry stool and bloody stool 2 and 1 days after the diagnosis of TIT, respectively, followed by respiratory and cardiac arrest, and died. Conclusions Extremely severe TIT has low incidence but urgent onset, which can lead to fatal bleeding events, and some patients may have no clinical symptoms. The prognosis is generally good after tirofiban withdrawal and receiving glucocorticoids and symptomatic treatments. However, it should be alert to the adverse consequences caused by secondary bleeding events.
Survey and analysis of the awareness and application status of drugs used with caution in myasthenia gravis patients Hot!
Ruan Shishuang, Di Li, Wang Yan, Fan Limei
Adverse Drug Reactions Journal. 2022, 24 (9): 478-483. ;  doi: 10.3760/cma.j.cn114015-20220510-00413
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Objective To understand the awareness and application status of drugs used with caution in myasthenia gravis (MG) patients. Methods The list of drugs that should be used with caution in MG patients was formulated through discussion among pharmaceutical experts and neurology experts in Xuanwu Hospital, Capital Medical University, including 10 categories and more than 50 drugs like anti- infective drugs, cardiovascular drugs, sedative-hypnotics, statins, antiepileptics, antipsychotics, analgesics, anaesthetics, spasmolytics, and others. The questionnaire survey on knowledge of drugs used with caution was conducted in outpatients with MG in the Department of Neurology between January 2021 and February 2022 in Xuanwu Hospital, Capital Medical University. The contents of the questionnaire included the general demographic data of patients, the disease course and type of MG, comorbidities, drug utilization, awareness and application of drugs used with caution in MG patients, and accesses to relevant drug use knowledge. The questionnaire was distributed on-site after the patient ended the visit, and the patients were asked to participate voluntarily and answer and return the questionnaire on the spot. The participants were divided into the with and without relevant knowledge groups according to whether they were aware of drugs used with caution in MG patients, and the clinical characteristics of the patients in the 2 groups were compared. Multivariate logistic regression analysis was used to analyze the influencing factors of awareness of drugs used with caution, and the odds ratio (OR) and 95% confidence interval (CI) were calculated. Results A total of 290 questionnaires were distributed and all of them were recovered. Among the 290 patients, 165 were male and 125 were female, and the disease course of MG ranged from 3 weeks to 360 months. The clinical subtypes were ocular MG in 179 patients and non-ocular MG in 111 patients. One or more chronic disease coexisted in 174 patients (60.0%), including hypertension, hyperlipidemia, diabetes mellitus, coronary atherosclerotic heart disease, immune system disease, anxiety/depression, etc. There were 248 patients (85.5%) who had received medications for MG. In the MG patients having access way to knowledge about drugs used with caution, there were 191 (92.7%), 26 (12.6%), 22 (10.7%), and 7 (3.4%) patients through the propagation by healthcare staff, bulletin boards/display boards in the hospital, networks, and books, respectively. There were 64.8% (188/290) of the patients knowing nothing about the drugs used with caution. After the diagnosis of MG, 110 patients had used the drugs that should be used with caution, and 7 (6.4%) had aggravated MG or adverse reactions later, of which 4 applied eye drops (quinolones and macrolides in 2 patients respectively). The independent influencing factors of low awareness of drugs used with caution were not receiving drugs for MG and not obtaining precautions in medication at the time of diagnosis (OR=6.811, 95%CI: 2.252-20.593, P=0.001; OR=5.615, 95%CI: 3.223-9.785, P<0.001). Conclusion Patients with MG have low awareness of the drugs used with caution, and neurology staffs should take more effective measures to the patient education about drugs used with caution.
Research progress on clinical monitoring of monoclonal antibody drugs
Ding Likun, Fan Tingting, Liu Meiyou, Guan Yue, Wang Jingwen, Wen Aidong
Adverse Drug Reactions Journal. 2022, 24 (9): 484-489. ;  doi: 10.3760/cma.j.cn114015-20210823-00920
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Monoclonal antibody (mAb) drugs belong to protein drugs, which are characterized by high relative molecular weight, strong polarity, and limited transmembrane. Their pharmacokinetics have certain particularity and complexity, and problems such as large individual differences in therapeutic effects, diverse biological effects, and loss of therapeutic response exist in clinical application. The blood concentration of mAb drugs is affected by many factors including the number of receptors at the target site, the level of anti-drug antibody, and the interaction between drugs. Early monitoring is helpful to timely adjust the dose of mAb drugs, improve the efficacy, and avoid or reduce the occurrence of adverse reactions. Clinical monitoring should be actively carried out to improve the level of rational use of mAb drugs and the ability of early warning of adverse reactions, so as to reduce the drug-induced injury in patients.
Esophagitis due to alendronate sodium
Chen Yanhao, Zhou Xiaobin, Fan Shuang, Wang Xiaodong, Duan Liwei
Adverse Drug Reactions Journal. 2022, 24 (9): 490-491. ;  doi: 10.3760/cma.j.cn114015-20220610-00513
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A 62-year-old female osteoporosis patient received alendronate sodium 70-mg orally once a week (taking the drug 30-minutes before breakfast with plenty of water and keeping upright during and after taking drug for a while). After taking the drug for 3 times, the patient developed retrosternal pain on swallowing with occasional acid aversion and epigastric dull pain. Gastroscopy showed multiple shallow ulcers, with yellow and white fur on the surface, in the esophagus 20-cm to 37-cm from the incisors. Esophagitis was considered, which might be related to alendronate sodium. Alendronate was stopped, and the treatments of acid suppression, mucosal repair, proper rehydration, and total liquid intake were given. Two days later, the stabbing pain behind the sternum was relieved; 7 days later, the pain was obviously relieved and symptoms of the acid aversion and epigastric dull pain disappeared; 1 month later, the retrosternal pain on swallowing disappeared.
Hypofibrinogenemia induced by orelabrutinib
Zhang Lina, Fang Wei, Li Jinfeng, Gao Jian, Wang Bing
Adverse Drug Reactions Journal. 2022, 24 (9): 492-494. ;  doi: 10.3760/cma.j.cn114015-20220119-00060
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A 78-year-old female patient was treated with orelabrutinib 100-mg once daily orally due to recurrence of lymphoma. On the 2nd day of treatment, the patient′s fecal occult blood was weakly positive. Three days later, fibrinogen was 0.61-g/L. After intravenous infusion of cryoprecipitated coagulation factor and frozen plasma, the fibrinogen level rose slightly. The patient did not follow the doctor′s advice and took orelabrutinib irregularly, and her fibrinogen level recovered to 1.71-g/L. After further regular treatment with orelabrutinib, her fibrinogen decreased to 0.74-g/L and irregular skin ecchymosis and bleeding spots appeared in the inner side skin of both lower limbs. The fibrinogen in the patient returned to 2.17-g/L after temporary suspension of orelabrutinib and receiving 2 times of intravenous infusion of cold precipitated coagulation factor 10 U, then decreased to 0.94 g/L after reuse of orelabrutinib, and finally recovered to 3.82-g/L after 3 times of intermittent infusion of cold precipitated coagulation factor. It is considered that the hypofibrinogenemia in the patient was caused by orelabrutinib.
Heart failure due to anlotinib
Wu Yupei, Yin Yuesong, Wang Qian, Wang Dongmiao, Zhang Lina
Adverse Drug Reactions Journal. 2022, 24 (9): 494-496. ;  doi: 10.3760/cma.j.cn114015-20220720-00655
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A 66-year-old female patient with infiltrating adenocarcinoma in left lung received anlotinib 12-mg orally once daily (2-week medication followed by 1-week discontinuation, 3 weeks was a cycle). After 14 months of regular medication, the patient developed palpitation and chest tightness. Laboratory tests showed that the N-Terminal pro-brain natriuretic peptid (NT-proBNP) was 1-698-ng/L; echocardiography showed decreased apical wall motion and left ventricular diastolic dysfunction. Heart failure was condsidered, which was suspected to be related to anlotinib. Anlotinib was stopped and symptomatic treatments were given. Eight days later, her symptoms above-mentioned were alleviated and NT-proBNP was 485-ng/L. Because of the illness condition, the patient took anlotinib again at original dose according to the doctor′s instructions. Three months later, the above symptoms recurred and ventricular fibrillation occurred suddenly. Considering that the heart failure in the patient might be caused by anlotinib. Anlotinib was stopped again. After 11 days of treatments with diuretics, cardiac function improvement, myocardial nutrition, and potassium supplement, the patient′s condition was improved obviously. After that, the patient did not take anlotinib again.
Skin rashes and immune-associated pneumonitis caused by nivolumab combined with tegafur- gimeracil-oteracil potassium
Sun Pengpeng, Zhang Hui, Jiang Yumin, Wang Jingdong, Zhang Meng
Adverse Drug Reactions Journal. 2022, 24 (9): 497-499. ;  doi: 10.3760/cma.j.cn114015-20220211-00112
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A 69-year-old male patient was treated with nivolumab combined with tegafur-gimeraci- loteracil potassium due to gastric adenocarcinoma with liver, pancreas, and abdominal lymph node metastasis after completing 4 cycles of chemotherapy with oxaliplatin and raltitrexed. Ten days later, the patient developed severe rashes all over the body, which was considered to be adverse skin reactions caused by nivolumab and tegafur-gimeracil-oteracil potassium. Then the 2 drugs were stopped and treatments with methylprednisolone and antiallergic drugs were given. The rashes were gradually improved, the dose of glucocorticoid was reduced gradually, and it was stopped at last. However, on the day of glucocorticoid withdrawal, the patient developed fever, chills, and severe respiratory failure. In combination with clinical treatment, laboratory test results, and imaging changes in the patient, it was considered to be immune-related pneumonitis caused by nivolumab. Methylprednisolone, anti-infection, and high-flow nasal cannula oxygen therapy were given. Four days later, the asthma symptoms in the patient were obviously improved, and 28 days later, the pulmonary CT showed the pneumonitis was markedly improved than before.
Fulminant type 1 diabetes mellitus caused by pembrolizumab
Tang Minqiong, Zhu Pengli
Adverse Drug Reactions Journal. 2022, 24 (9): 500-502. ;  doi: 10.3760/cma.j.cn114015-20220126-00082
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A 73-year-old female patient received monotherapy with pembrolizumab (IV infusion of 200-mg once every 3 weeks) for lung cancer with bone metastases. On day 12 after the 6th treatment with pembrolizumab, the patient developed severe nausea and vomiting. Laboratory tests showed random blood glucose 53.6-mmol/L and serum potassium 6.8-mmol/L. Blood gas analysis showed pH 7.3, partial pressure of carbon dioxide 19.5-mmHg, partial pressure of oxygen 15.6-mmHg, base excess -8.9-mmol/L, bicarbonate 9.5-mmol/L, lactic acid 2.5-mmol/L, and anionic gap 23.5-mmol/L. Blood ketone body test was positive. The patient had no previous history of diabetes mellitus, fulminant type 1 diabetes mellitus and ketoacidosis due to pembrolizumab were considered. Pembrolizumab were stopped and rehydration, hypoglycemia, acidosis correction, and other symptomatic treatments were given. Seven days later, her symptoms were improved partly. Laboratory tests showed fasting blood glucose 12.9-mmol/L and serum potassium 4.5-mmol/L. Blood gas analysis showed pH 7.5, bicarbonate 28.3-mmol/L, and base excess +5.7-mmol/L. Blood ketone body test was negative.
Acute liver and kidney injury caused by orlistat capsules
Li Chen, Su Haibin, Hu Jinhua, Shi Chenhui
Adverse Drug Reactions Journal. 2022, 24 (9): 502-504. ;  doi: 10.3760/cma.j.cn114015-20220119-00058
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A 37-year-old female patient took orlistat capsules 120-mg thrice daily orally for weight loss. Four weeks later, she developed fatigue, poor appetite, and nausea; 6 weeks later, jaundice and decreased urine volume occurred and laboratory tests showed alanine aminotransferase (ALT) 7-631-U/L, aspartate aminotransferase (AST) 6-295-U/L, total bilirubin (TBil) 46.0-μmol/L, serum creatinine (Scr) 266-μmol/L, and international normalized ratio (INR) 1.73. Acute liver and kidney injury caused by orlistat capsules was considered. Then orlistat was discontinued, and symptomatic and supportive treatments such as liver protection, enzyme lowering, fluid replacement, and renal perfusion improvement were given. Ten days later, the symptoms above-mentioned in the patient were improved obviously, and laboratory tests showed ALT 181-U/L, AST 25-U/L, TBil 9.8-μmol/L, Scr 121-μmol/L, and INR 0.9. The liver and renal function in the patient was normal both at 3 months and 1 year of follow-up.
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