Office Online  
    Online Submission
    Manuscript Tracking
    Editor Work
    Office Work
    Editor-in-chief
  Journal Online
    Current Issue
    Advanced Search
    Archive
    Read Articles
    Download Articles
    Email Alert
    
 

2019, 21(1)
HighLights More»   
· Annual report on clinical medication safety of National Monitoring Network for Clinical Safe Medication (2018)
· Management strategy study on lyophilizing thrombin powder based on failure mode and effect analysis
· Analysis on rationality of antihyperuricemic drugs application and detection of HLA-B*5801 alleles in patients with chronic kidney diseases complicated by hyperuricemia
· Analysis of medication safety self-assessment results of 67 hospitals in China
Current Issue Accepted Earlier Issues Top Read Top Downloaded
  Adverse Drug Reactions Journal--2019, 21 (1)   Published: 28 February 2019
Select | Export to EndNote

Adverse Drug Reactions Journal. 2019, 21 (1): 1-1. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.001
Full Text: HTML (1 KB)  PDF  (143 KB)  (143KB) ( 1 )
Show Abstract ( 3 )
Annual report on clinical medication safety of National Monitoring Network for Clinical Safe Medication (2018) Hot!
Zhang Qingxia, Wang Yawei, Li Xiaoling, Wang Yuqin, Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs, Chinese Pharmacological Society Professional
Adverse Drug Reactions Journal. 2019, 21 (1): 2-8. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.002
Full Text: HTML (1 KB)  PDF  (1039 KB)  (1039KB) ( 7 )
Show Abstract ( 4 )
The National Monitoring Network for Clinical Safe Medication was established in September 2012 by Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs (INRUD). As of December 31, 2018, a total of 40 873 cases of medication error (ME) were collected. In 2018, 11 761 cases of medication error (ME) from 177 hospitals in 24 provincial administrative regions were reported in China, of which 55 (0.47%) were classified as grade A, 9 419 (80.09%) as grade B, 2 001 (17.01%) as grade C, 179 as grade D ( 1.52%), 69 (0.59%) as grade E, 33 (0.28%) as grade F, 3 (0.02%) as grade G, 2 (0.02%) as grade H, and 0 as grade I; of which a total of 107 cases (0.91%) were determined as serious ME because of leading to patient harm. A total of 11 706 cases of ME (grade B-H) involved patients, including 6 668 males (56.96%) and 5 038 females (43.04%). These patients aged from 1 day to 105 years, of which 1 365 patients (11.66%) aged <18 years, 5 956 patients (50.88%) aged ≥18 to <60 years, and 4 385 patients (37.46%) aged <60 years. The top 3 drugs involved in serious ME were vancomycin hydrochloride, cefoperazone sulbactam, and methotrexate tablets. The 55 cases of class A ME did not involve people who triggered the ME and places where ME occurred in. In the 11 706 cases of class B-H ME, 7 128 (60.89%) were triggered by physicians, 2 920 (24.94%) by pharmacists, 513 (4.38%) by nurses, 124 (1.06%) by patients and their families, and 1 021 (8.72%) by other people; 4 369 (37.32%) occurred in the clinic, 3 625 (30.97%) in the pharmacy, 646 (5.52%) in the pharmacy intravenous admixture services, 230 (1.96%) in the nurse station, 48 (0.41%) at home, 1 (0.01%) in the community health service station, and 178 (1.52%) in other places. The top 3 contents of ME were wrong drug class, wrong total dose, and wrong single dose. The top 3 people who discovered the ME mostly were pharmacists, nurses, and patients and their families. The top 3 factors mainly causing ME were lack of related pharmacologic knowledge of medical staff, tiredness of medical staff, and presence of look alike and sound alike drugs.
Management strategy study on lyophilizing thrombin powder based on failure mode and effect analysis Hot!
Han Yuanyuan1, Liu Nannan1, Zhang Lei1, Wang Yawei2, Yan Suying2, Wang Yuqin2, Liu Fang3, Lu Jin1
Adverse Drug Reactions Journal. 2019, 21 (1): 9-14. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.003
Full Text: HTML (1 KB)  PDF  (919 KB)  (919KB) ( 1 )
Show Abstract ( 3 )
ObjectiveTo explore the application of failure mode and effect analysis (FMEA) in improving the management strategies of high alert medication (HAM), such as lyophilizing thrombin powder.MethodsThe study groups on medication risk and its prevention strategies of lyophilizing thrombin powder were set up in China-Japan Friendship Hospital and Xuanwu Hospital, Capital Medical University, respectively. The possible failure modes appearing in clinical application of lyophilizing thrombin powder were collected by questionnaire survey and on-the-spot investigation. The risk priority number (RPN) scores were calculated according to the score results of severity, frequency of occurrence, and likelihood of detection. Failure modes with higher RPN scores were screened out and the corresponding prevention strategies were formulated. The situations in related links before and after improvement of the strategies were analyzed comparatively. ResultsThe results from questionnaire survey and on-the-spot investigation showed a total of 37 failure modes in the links of information system, physician prescription, drug dispensing, medical order execution by nurses, and medication error reporting. Ranking the RPN scores from high to low, 15 major failure modes were screened out, including 4 modes in information system link (not setting the lyophilizing thrombin powder administration route as "oral", lack of HAM labels, lack of photo library of confusing drugs, and lack of real-time reporting program of medication errors), 2 modes in physician prescription link (existence of confusing drugs and physician prescription errors), 4 modes in drug dispensing link (lack of prescription/medication orders auditing by pharmacist, absence of the pharmacist′s double check in drug dispensing and distributing, lack of location mark of HAM and confusing drug for lyophilizing thrombin powder in the pharmacy, and no special storage area for lyophilizing thrombin powder in the pharmacy), 4 modes in the link of medical order execution by nurses (negligence in check of the administration route of lyophilizing thrombin powder, existence of nurses in ward who were unfamiliar with the drug knowledge, no double check in drug distribution, and lack of location mark of HAM and confusing drugs in the ward), and 1 mode in medication error reporting link (no real-time information sharing system for medication errors among different wards). After drawing up the improvement measures of management, no medication errors occurred during the lyophilizing thrombin powder application in the 2 hospitals. Before and after the improvements, the percentages of physicians, pharmacists and nurses knowing that lyophilizing thrombin powder package should be with a special mark were 33.3% (12/36) and 83.3% (30/36), and the percentages of those knowing the right route to report medication errors were 77.8% (28/36) and 100% (36/36), respectively, with statistically significant differences (P<0.05 for both).ConclusionsFMEA method can be used to screen the failure modes during the lyophilizing thrombin powder application effectively. The improvement of management measures for lyophilizing thrombin powder application has a positive effect on the improvement of medication safety.
Analysis on rationality of antihyperuricemic drugs application and detection of HLA-B*5801 alleles in patients with chronic kidney diseases complicated by hyperuricemia Hot!
Zhang Di1, Chen Siying1,Yang Zhihua1, Lu Wanhong2, Dong Yalin1
Adverse Drug Reactions Journal. 2019, 21 (1): 15-19. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.004
Full Text: HTML (1 KB)  PDF  (776 KB)  (776KB) ( 4 )
Show Abstract ( 7 )
ObjectiveTo analyze the rationality of antihyperuricemic drugs application and HLA-B* 5801 alleles detection in patients with chronic kidney diseases complicated by hyperuricemia.MethodsThe medical  records of patients with chronic kidney diseases complicated by hyperuricemia in the First Affiliated Hospital of Xi′an Jiaotong University from July 2015 to June 2017, whose HLA-B*5801 alleles were detected and who were treated with benzbromarone, allopurinol, or febuxostat, were collected and analyzed retrospectively. The evaluation criteria of rationality of 3 antihyperuricemic drugs application and gene detection were constituted according to the related guidelines, expert consensuses, and drug labels. It was judged as irrational use of benzbromarone in patients with estimating glomerular filtration rate (eGFR) <30 ml/(min·1.73 m2), excessive uric acid production, acute gout attack, urinary calculi, or undetermined uric acid excretion type. It was judged as irrational use of allopurinol in patients whose eGFR were <15 ml/(min·1.73 m2) but without dialysis or in patients with positive HLA-B*5801 alleles. It was judged as irrational use of gene detection in patients who had underwent gene detection but were not suitable for allopurinol treatment after initial assessment, and in patients who finally were not given allopurinol though they were suitable for allopurinol treatment after initial assessment and with negative HLA-B*5801 alleles.ResultsA total of 201 patients enrolled in the study. There were 57, 103, and 41 patients receiving benzbromarone, allopurinol, and febuxostat, respectively. There were 24 (11.9%) patients with positive HLA-B*5801 alleles and 177 (88.1%) with negative one. The percentages of patients with rational use of benzbromarone, allopurinol, and febuxostat were 40.4% (23/57), 76.7% (79/103) and 100% (41/41), respectively. The percentage of patients with rational use of HLA-B*5801 alleles detection was 50.2% (101/201). There were 100 patients with irrational use of HLA-B*5801 alleles detection, including 34 patients who underwent gene detection but were not suitable for allopurinol treatment [their eGFRs were<15 ml/(min·1.73 m2) but they did not conduct dialysis], and 66 patients who were not given allopurinol despite that they were suitable for allopurinol treatment with negative HLA-B*5801 alleles.ConclusionsThere are irrational use of both antihyperuricemic drugs and HLA-B*5801 alleles detection in patients with chronic kidney diseases complicated by hyperuricemia in our hospital. Irrational use of benzbromarone is more serious in antihyperuricemic drugs. Clinicians should pay attention to the irrational use of antihyperuricemic drugs.
Analysis of medication safety self-assessment results of 67 hospitals in China Hot!
Li Xiaoling1, Zhao Simiao1, Wang Yawei1, et al
Adverse Drug Reactions Journal. 2019, 21 (1): 20-29. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.005
Full Text: HTML (1 KB)  PDF  (1598 KB)  (1598KB) ( 2 )
Show Abstract ( 2 )
ObjectiveTo preliminarily understand the current status of medication safety management of medical institutions in China.MethodsMedication Safety Panel in China Core Group of International Network for the Rational Use of Drugs (INRUD) and Chinese Pharmacological Society Professional Committee of Drug-induced Diseases jointly established a research group. Basing on the voluntary principle, members (medical institutions) of the group did medication safety self-assessment using the questionnaires of "2011 ISMP Medication Safety Self Assessment for Hospitals (Chinese version)", which included 10 key elements, 20 core indicators, and 270 assessment projects. The questionnaires were handed out on August 17, 2018 and needed to be completed and submitted within 2 months.ResultsAs of October 19, 2018, 67 hospitals of 16 provincial administrative regions in total had submitted their questionnaires, including 61 (91.0%) 3A hospitals and 6 (9%) 2A hospitals. The average value of total scores of medication safety self-assessment in the 67 hospitals was 58.9% (7.6%-90.0%). None of the 67 hospitals evaluated the key element Ⅵ(medication device acquisition, use, and monitoring). The scores of the other 9 key elements from high to low were 67.6%, 66.2%, 65.1%, 64.8%, 64.1%, 58.2%, 54.5%, 54.4%, and 52.5% respectively for element Ⅶ (environmental factors, workflow and staffing patterns), element Ⅳ(drug labeling, packaging and nomenclature), element Ⅸ (patient education), element Ⅲ(communication of drug orders and other drug information), element Ⅷ (staff competency and education), element Ⅴ(drug standardization, storage and distribution), element Ⅹ (quality processes and risk management), element Ⅰ (patient information), and element Ⅱ (drug information).ConclusionThe data of medication safety from 67 hospitals of 16 provincial administrative regions were obtained through the first national self-assessment questionnaire survey in medical institutions, which initially reflected the current status of medication safety in medical institutions in China.
Causality assessment of adverse events in phase Ⅰ clinical trials
Wang Chunhua1,2, Hu Xiao2, Yang Cuicui2, Hu Chaoying2, Zhang Lan1,2
Adverse Drug Reactions Journal. 2019, 21 (1): 30-35. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.006
Full Text: HTML (1 KB)  PDF  (970 KB)  (970KB) ( 1 )
Show Abstract ( 3 )
Phase I clinical trial is a preliminary clinical pharmacology and human safety evaluation test of investigational products and used to observe the tolerance of human body to investigational products and obtain pharmacokinetic data in human body. The lack of clinical safety data of investigational products makes it difficult to judge the causality of adverse events (AE) in trials. There is no uniform criteria for causality assessment. Hill criterion is more widely used at present. There are 3 methods to assess the causality between investigational products and AE: expert judgment, algorithms, and probabilistic approaches. The major method for causality assessment of AE used in China, which is similar to the expert judgment method, is basically consistent with that in the World Health Organization′s Uppsala Monitoring Center (UMC). However, these evaluation methods are more suitable for post-marketing drug evaluation than for phase I clinical trials. With the join of our country in the International Conference on Harmonisation(ICH), Phase I clinical trials have gradually increased. Related evaluation guidelines should be published and an AE database should be established in China, basing on the metabolic and pharmacodynamic characteristics of the investigational products (including data from the preclinical studies) and the clinical manifestations of the subjects, and referring to the Hill criteria commonly used in the world, to conduct phase I clinical trials well on the premise of guaranteeing the safety of the subjects and provide more valuable and accurate information for the following studies of investigational products at home and abroad.
Research progress of safety alerts in computerized prescriber order entry system
Liu Baogang1, Li Xiaoling1, Yan Suying1, Wang Ruili2, Zhang Bin1, Cui Xiaohui1
Adverse Drug Reactions Journal. 2019, 21 (1): 36-42. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.007
Full Text: HTML (1 KB)  PDF  (1170 KB)  (1170KB) ( 2 )
Show Abstract ( 3 )
The study on safety alerts in computerized physician order entry started from the 90s of 20 century. The forms of safety alerts comprised mainly 2 kinds, invasive and non-invasive alerts. The contents of alert mainly included drug-drug interaction(DDI), medication of patients with renal insufficiency, potential inappropriate medication of the elderly, irrational use of antibiotics, medication of pregnancy women, and drug allergy. Comparing with non-invasive alerts and non-tiered alerts respectively, the rates of prescription modification due to invasive alerts and tiered alerts increased significantly. The rate of prescription modification due to DDI alerts was significantly higher than that due to potential inappropriate medication alerts of the elderly or drug allergy alerts. Most studies have suggested that the rate of prescription errors decreased after using the electronic prescription safety alert system, and the major factor affecting the effectiveness was alert fatigue. The factors affecting the acceptance rates of alerts mainly included the alert interface setting (color, shape, and etc.), the content of the alerts, the type of drugs, being tiered or not according to the severity of alerts, specific recommendations for prescription modification being given or not, repetition rate of the alerts, and the prescribers′ professional level, and etc. The developments of safety alerts in computerized prescriber order entry system in the United States, United Kingdom, and Japan are relatively mature and their hospital popularity rates are relatively high. The research on safety alerts in computerized prescriber order entry system in China is relatively late and needs to be further strengthened.
Interpretation of clinical drug interaction studies—study design, data analysis, and clinical implications guidance for industry(draft guidance)
Li Xiao1, Liu Ruining2, Liu Zhijun1
Adverse Drug Reactions Journal. 2019, 21 (1): 43-49.
Full Text: HTML (1 KB)  PDF  (1115 KB)  (1115KB) ( 1 )
Show Abstract ( 4 )
Center for Drug Evaluation and Research of the Food and Drug Administration of the United States renewed the "clinical drug interaction studies-study design, data analysis, and clinical implications guidance for industry(draft guidance)" in 2017. In this paper, the importance of research on drug interaction of new drugs, reference drugs in research on drug interaction, research on interaction of anticipated clinical combination drugs, design and precautions of prospective research on drug interaction, research precautions of cytochrome P450-mediated drug interaction, research precautions of drug transporter-related drug interaction, other precautions on drug interaction research, description of drug interaction information in drug labels, and etc. were interpreted, so as to provide reference for rational drug use in clinical.
Cinitapride hydrogen tartrate, a gastrointestinal promotility drug
Shen Aizong, Zhang Shengyu, Su Dan, Fang Xiaolin, Chen Di
Adverse Drug Reactions Journal. 2019, 21 (1): 50-54. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.009
Full Text: HTML (1 KB)  PDF  (790 KB)  (790KB) ( 1 )
Show Abstract ( 4 )
Gastrointestinal promotility drugs are effective in treating gastrointestinal diseases such as functional dyspepsia (FD) and gastroesophageal reflux disease (GERD), but there are few effective and safe drugs in the present. Cinitapride hydrogen tartrate (cinitapride) is a gastrointestinal promotility drug that marketed in China in 2015. It belongs to 5-hydroxytryptamine receptor agonist and is mainly used to treat mild to moderate FD. Several clinical trials have shown that cinitapride is superior to metoclopramide or domperidone for treatment of gastrointestinal dysfunction, FD and GERD, and has good safety. Because cinitapride is metabolized not only by cytochrome P450 (CYP) 3A4 enzyme but also by CYP2C8, the risk of drug interaction is lower. The free drug concentration of cinitapride is much lower than that of cisapride and domperidone, resulting in a lower risk of cardiotoxicity. So cinitapride is a new choice for treatment of FD and GERD.
efadroxil tablets induced-drug hypersensitivity syndrome complicated with acute myocarditis and death
Dong Shujie1, Cao Ke2, Zhai Suodi1
Adverse Drug Reactions Journal. 2019, 21 (1): 55-56. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.010
Full Text: HTML (1 KB)  PDF  (295 KB)  (295KB) ( 1 )
Show Abstract ( 6 )
A 61-year-old female patient took cefadroxil tablets 0.5 g twice daily herself due to fever after blepharorrhaphy in her right eye. Her temperature returned to normal, but the medication was not discontinued and 2 weeks later, the patient developed skin rash on her limbs with severe itching, and fever (39 ℃). Then cefadroxil tablets were stopped but her symptoms were gradually aggravated, and then facial swelling appeared 5 days later. On the seventh day of onset, she was admitted to the hospital, with white blood cell count 25×109/L, percentage of eosinophils 0.29, eosinophil count 7.4×109/L, and normal liver and kidney function, myocardial enzymes, and electrocardiogram. Antiallergic and symptomatic treatments were given after the admission. On day 4 of admission, the patient developed dizziness and general fatigue. Her blood pressure was 96/61 mmHg and her heart rate was 110 beats per minute. The electrocardiogram showed multilead ST segment elevations and the echocardiography revealed a small amount of pericardial effusion. Laboratory tests showed that the cardiac troponin T (cTnT) was 1.52 μg/L, creatine kinase (CK) was 236 U/L, CK-MB was 63 U/L, and N-terminal pro-brain natriuretic peptide (NT-proBNP) was 9 708 ng/L. The patient was diagnosed with drug hypersensitivity syndrome complicated with acute myocarditis and pericarditis. Intravenous infusion of high dose methylprednisolone (500 mg/d), human immunoglobulin (40 g/d), and myocardial nutrition treatments were given. On day 5 of admission, the patient was transferred to the cardiovascular care unit (CCU), when her blood pressure was 80/50 mmHg, CK was 498 U/L, CK-MB was 98 U/L, cTnT was 5.33μg/L, and left ventricular ejection fraction was 55%. However, the patient′ myocarditis and pericarditis progressed rapidly. On day 3 in the CCU, the laboratory tests showed CK 1 252 U/L, CK-MB 231 U/L, cTnT 4.57 μg/L, NT-proBNP 17 979 ng/L, and left ventricular ejection fraction 10%, which then decreased to 5% on day 6. Finally, the patient died on day 9 in the CCU.
Hemolytic-uremic syndrome due to gemcitabine
iu Xuejia1, Yao Difei2, Dong Zhanjun1
Adverse Drug Reactions Journal. 2019, 21 (1): 57-58.
Full Text: HTML (1 KB)  PDF  (297 KB)  (297KB) ( 1 )
Show Abstract ( 3 )
A 25-year-old male patient with epithelioid hemangioendothelioma received periodic chemotherapy with gemcitabine 1 600 mg (on day 1 and 8 of each chemotherapy cycle) and docetaxel 110 mg (on day 8 of each chemotherapy cycle) and the chemotherapy cycle was 21 days. The patient developed fever on day 7 after the first IV infusion of gemcitabine in the third chemotherapy cycle and then the following infusions of this cycle was abandoned. Thirty days later, he was hospitalized in the Second Affiliated Hospital of Zhejiang University School of Medicine to undergo the fourth chemotherapy cycle. On day 4 after hospitalization, the patient developed urinary incontinence and 900 ml of soy sauce-colored liquid was drained by catheter. Laboratory tests showed red blood cell count 2.19×1012/L, hemoglobin 63 g/L, and platelet 257×109/L. The patient was diagnosed as hemolytic-uremic syndrome due to gemcitabine. The patient′s condition improved after IV infusions of alprostadil injection, reduced glutathione for injection, and suspended red blood cells for 6 days.
Vitamin K-dependent coagulation factor deficiency due to cefminox sodium
Zhao Rui, Ma Jingting, Wei Lina, Li Dongfu
Adverse Drug Reactions Journal. 2019, 21 (1): 59-60. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.012
Full Text: HTML (1 KB)  PDF  (304 KB)  (304KB) ( 10 )
Show Abstract ( 3 )
A 55-year-old female patient with cholecystitis, gallstone and secondary acute pancreatitis received an IV infusion of cefminox sodium 2.0 g twice daily. Eight days later, she developed large area of ecchymosis on her skin below the waist and abdomen, especially on that of the lower limbs. Laboratory tests showed the prothrombin time (PT) 63.0 s, prothrombin activity (PTA) 0.12, international normalized ratio (INR) 5.21, coagulation factor II activity 0.32, coagulation factor VII activity 0.02, and coagulation factor X activity 0.27. Vitamin K-dependent coagulation factor deficiency due to cefminox sodium was considered. Cefminox sodium was stopped immediately and an intramuscular injection of mephyton 10 mg once daily was given. Three days later, the laboratory tests showed PT 11.0 s, PTA 1.12, INR 0.94, coagulation factor II activity 0.83, coagulation factor VII activity 0.73, and coagulation factor X activity 0.84.
Nephrotic syndrome induced by tiopronin
Zhang Lixin, Niu Kai
Adverse Drug Reactions Journal. 2019, 21 (1): 61-62. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.013
Full Text: HTML (1 KB)  PDF  (277 KB)  (277KB) ( 1 )
Show Abstract ( 2 )
An 80-year-old male patient with lumbar vertebral tuberculosis took tiopronin (0.2 g, thrice daily) to protect liver during chemotherapy for tuberculosis. After 7 months of treatment, eyelids and lower limbs edema appeared, then abdominal distension and urine volume decrease appeared gradually (urine volume was about 800 ml within 24 hours). Laboratory test showed that the serum total protein was 49 g/L, albumin was 18 g/L, urine protein was positive (+++), 24-hour urine protein quantitation was 3 720 mg(24-hour urine volume was 750 ml ). Tiopronin was stopped, antituberculotic therapy was continued, and symptomatic supportive treatments including antihypertensive, anticoagulant, diuretic, and kidney-protective therapy were given. Two weeks later, the patient′s edema disappeared, serum albumin increased to 25 g/L, and 24-hour urine protein quantitation decreased to 1 296 mg (24 hours urine volume was 1 500 ml). Four weeks later, urine protein test turned negative. At 6 months of follow-up, above mentioned symptoms did not recur.
Hypertension and elevated urinary free cortisol level caused by Anweiyang capsules(安胃疡胶囊)
Li Yueyang1, Wang Yan2, Zhao Hongwei1, Zhang Yongkai1
Adverse Drug Reactions Journal. 2019, 21 (1): 62-64. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.014
Full Text: HTML (1 KB)  PDF  (453 KB)  (453KB) ( 1 )
Show Abstract ( 3 )
A 65-year-old male patient received oral Anweiyang capsules 0.4 g four times daily for chronic gastritis. About 1 month after the medication, the patient developed intermittent headache, dizziness, and increased blood pressure, whose highest value was 180/100 mmHg. Levamlodipine besylate tablets 2.5 mg once daily was given orally but the patient′s blood pressure was not well controlled. About 4 months later, laboratory tests showed obviously increased free cortisol in urine (2 330 nmol/24 h), which was considered to be caused by Anweiyang capsules. Anweiyang capsules were stopped and the patient continued to take levamlodipine besylate tablets. On day 4 after the drug withdrawal, the patient′s blood pressure and urinary free cortisol began to decrease, which finally returned to normal on day 9. At 1 month of follow-up, no abnormalities were found on the blood pressure and urinary free cortisol in the patient.
Immune-related pneumonia induced by nivolumab
Liu Li1, Gong Qian2
Adverse Drug Reactions Journal. 2019, 21 (1): 64-66. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.015
Full Text: HTML (1 KB)  PDF  (460 KB)  (460KB) ( 3 )
Show Abstract ( 5 )
A 68-year-old male patient with lung adenocarcinoma and bone and adrenal metastasis received an IV infusion of nivolumab 180 mg (on day 1 of each chemotherapy cycle of 14 days), and completed 3 cycles in total. On day 70 after the first infusion, the patient developed fever, cough with sputum, and dyspnea. The above symptoms aggravated gradually despite oxygen and anti-infective treatment for 3 days. Blood gas analysis indicated type I respiratory failure. Ground glass opacities and reticular opacities in bilateral lungs were found in the chest CT. Considering the immune-related pneumonia complicated by infection induced by nivolumab, high-dose methylprednisolone was given to inhibit the immune response, meropenem and voriconazole were given to prevent infection, and oxygen and expectorants were given as the symptomatic and supportive treatments. Finally the symptoms of the patient gradually relieved.
Toxic encephalopathy in a child induced by mistaken use of compound diphenoxylate hydrochloride in overdose
Fu Zhengran1, Wang Xiaoling1, Bian Guangbo2, Fang Fang3
Adverse Drug Reactions Journal. 2019, 21 (1): 67-68. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.016
Full Text: HTML (1 KB)  PDF  (314 KB)  (314KB) ( 0 )
Show Abstract ( 3 )
A 2 years and 4 months old boy mistakenly took 10-20 tablets of compound diphenoxylate hydrochloride placed by his parents at the bedside. About 2 hours after taking the medicine by mistake, the boy developed lethargy and, about 3 hours after the medicine, he developed cyanosis of lips and lethargy accompanied by snoring. About 6 hours after the medicine, the boy was sent to the local hospital and treatments such as gastric lavage and oxygen inhalation were given. About 9 hours after the medicine, the boy was transferred to the General Hospital of Ningxia Medical University. After 7 days of symptomatic and supportive treatments, such as mechanical ventilation via tracheal intubation, naloxone rescue, fluid replacement, and diuresis, the consciousness of the child improved and he could breathe spontaneously. However, the boy still had high muscle tension of his limbs, exaggerated bilateral tendon reflexes, positive Babinski sign, positive ankle clonus, and intermittent paroxysmal postural abnormalities. The head Magnetic Resonance Imaging showed multiple abnormal signal foci in bilateral cerebellar hemisphere, parieto-occipital lobe, peri-lateral ventricle, anterior and posterior periventricular and corpus callosum. He was diagnosed as toxic encephalopathy and symptomatic epilepsy. One year later, it was known by telephone follow-up that the boy had severe mental retardation.
Acute liver failure following combined use of apatinib and vinorelbine in an advanced breast cancer patient
Zhou Xuehui1, Chen Yan2, Yang Yongtao2
Adverse Drug Reactions Journal. 2019, 21 (1): 69-70. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.017
Full Text: HTML (1 KB)  PDF  (295 KB)  (295KB) ( 0 )
Show Abstract ( 4 )
A 51-year-old female patient with breast cancer received apatinib 0.5 g/d orally on day 1 to 8 and vinorelbine 40 mg/d orally on day 1 to 3 for liver, bone, and lymph node metastasis. The treatment course was 21 days. Before medication, the patient′s liver and kidney functions were normal. On day 6 of the first course, the patient presented with abdominal pain accompanied by black stool. No improvement was observed after acid suppression and mucosal protection treatments. On day 9, laboratory tests showed alanine aminotransferase (ALT) 87 U/L, aspartate aminotransferase (AST) 529 U/L, gamma glutamyl transpeptidase (γ-GT) 520 U/L, total bilirubin (TBil) 43.70 μmol/L, direct bilirubin(DBil) 15.50 μmol/L; CT examination showed multiple low-density nodules in the liver, widening of intrahepatic bile duct, thickening of gallbladder wall, and a small amount of hydrothorax and peritoneal effusion.Acute liver failure was diagnosed. Omeprazole, somatostatin, polyene phosphatidylcholine, reduced glutathione, complex coenzyme, thrombin, and sodium carosulfonate were given. On day 11, the patient developed dysphoria, shortness of breath, anuria and other symptoms. The laboratory tests showed ALT 1 447 U/L, AST 6 060 U/L, γ-GT 386 U/L, TBil 135.60 μmol/L, DBil 93.20 μmol/L. His family members gave up treatments. There was a clear time correlation between the acute liver failure and the application of apatinib and vinorelbine in the patient. So the acute liver failure was considered to be caused by the combination use of the two drugs.
Neutrophils deficiency induced by linezolid tablets
Hong Liangliang, Qian Xiaorong, Zhang Tao
Adverse Drug Reactions Journal. 2019, 21 (1): 71-72. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.018
Full Text: HTML (1 KB)  PDF  (286 KB)  (286KB) ( 7 )
Show Abstract ( 4 )
A 4 years and 10 months old boy received an intravenous infusion of vancomycin for suppurative arthritis of left hip joint. Before treatment, the laboratory tests showed white blood cell count (WBC) 8.11×109/L and neutrophil count (NEUT) 4.06×109/L. On day 11 of treatment, the symptoms improved markedly and the laboratory tests showed WBC 6.28×109/L and NEUT 1.28 ×109/L. On day 12, the boy developed skin rash. On day 13, vancomycin was discontinued and changed to oral linezolid tablets 0.15 g thrice daily, with no other combination drugs. After taking linezolid tablets, the NEUT decreased to 0.52×109/L, increased to 1.64×109/L, and dropped again to 0.25×109/L respectively on day 2, day 5, and day 13. Neutrophil deficiency induced by linezolid tablets was considered. Then linezolid tablets were discontinued. Five days later, the NEUT increased to 1.65×109/L.
Topiramate-induced male sexual dysfunction: a report of two cases
Liu Jinyu1,2, Chen Xiaoqian1,2, Wang Wenjie1,2, Li Chunhua3, Ni Jianqiang1, Xue Qun1, Xu Min1,
Adverse Drug Reactions Journal. 2019, 21 (1): 72-74. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.019
Full Text: HTML (1 KB)  PDF  (459 KB)  (459KB) ( 0 )
Show Abstract ( 3 )
Two male patients (patient 1, 30 years old; patient 2, 54 years old) were treated with topiramate for symptomatic epilepsy and migraine, respectively. The dosage of topiramate in patient 1 was 50 mg/d and 75 mg/d in the first and second weeks, respectively, and 100 mg/d since the third week. Six months after topiramate treatment, the patient told the doctor that his epilepsy did not recur, but he developed hypomnesia, decreased libido, and premature ejaculation when topiramate was taken for 2 weeks. He did not stop topiramate despite that his symptoms persisted. The International Index of Erectile Function (IIEF) score showed that IIEF-1 score was 19 and IIEF-5 score was 16. He was diagnosed as sexual dysfunction. Levetiracetam was given for epilepsy, and topiramate was gradually reduced and finally discontinued within one month. The patient′s sexual dysfunction improved after 2 weeks of topiramate reduction, disappeared after one month of drug withdrawal, and the IIEF-1 score was 28. The patient 2 took topiramate at a dose of 50 mg/d. After 2 weeks of topiramate treatment, the patient developed decreased libido and erectile dysfunction. The IIEF-1 score was 23. Because the drug was effective in treating his headache, the patient took topiramate intermittently during headache attacks. The patient′s anaphrodisia and erectile dysfunction persisted.

Adverse Drug Reactions Journal. 2019, 21 (1): 75-75. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.020
Full Text: HTML (1 KB)  PDF  (139 KB)  (139KB) ( 3 )
Show Abstract ( 2 )

Adverse Drug Reactions Journal. 2019, 21 (1): 76-76. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.021
Full Text: HTML (1 KB)  PDF  (145 KB)  (145KB) ( 1 )
Show Abstract ( 3 )

Adverse Drug Reactions Journal. 2019, 21 (1): 77-77. ;  doi: 10.3760/cma.j.issn.1008-5734.2019.01.022
Full Text: HTML (1 KB)  PDF  (162 KB)  (162KB) ( 0 )
Show Abstract ( 2 )
Adverse Drug Reactions Journal
Accepts
Note: The papers published below will continue to be available from this page until they are assigned to an issue. To see an article, click its [PDF] link. To review many abstracts, check the boxes to the left of the titles you want, and click the 'Selected articles' button. To see one abstract at a time, click its [Abstract] link.
Adverse Drug Reactions Journal
2018 Vol.20      No.1      No.2      No.3      No.4      No.5      No.6
2017 Vol.19      No.1      No.2      No.3      No.4      No.5      No.6
2016 Vol.18      No.1      No.2      No.3      No.4      No.5      No.6
2015 Vol.17      No.1      No.2      No.3      No.4      No.5      No.6
2014 Vol.16      No.1      No.2      No.3      No.4      No.5      No.6
2013 Vol.15      No.1      No.2      No.3      No.4      No.5      No.6
2012 Vol.14      No.1      No.2      No.3      No.4      No.5      No.6
2011 Vol.13      No.3      No.1      No.1      No.2      No.3      No.4
     No.5      No.6
2010 Vol.12      No.1      No.2      No.3      No.4      No.5      No.6
2009 Vol.11      No.1      No.2      No.3      No.4      No.5      No.6
2008 Vol.10      No.1      No.2      No.3      No.4      No.5      No.6
2007 Vol.9      No.1      No.2      No.3      No.4      No.5      No.6
2006 Vol.8      No.1      No.2      No.3      No.4      No.5      No.6
2005 Vol.7      No.1      No.2      No.3      No.4      No.5      No.6
2004 Vol.6      No.1      No.2      No.3      No.4      No.5      No.6
2003 Vol.5      No.1      No.2      No.3      No.4      No.5      No.6
2002 Vol.4      No.1      No.2      No.3      No.4      No.5      No.6
2001 Vol.3      No.1      No.2      No.3      No.4
2000 Vol.2      No.1      No.2      No.3      No.4
1999 Vol.1      No.1      No.2      No.3
药物不良反应杂志社
 Top Read
»

Pay attention to vancomycin-associated nephrotoxicity and its prevention

Zeng Jiawei, Chen Xiao
2018, 20(2): 82-82. Full Text: PDF (303KB) (300)
»

Clinical analysis of drug-induced kidney injury in 20 inpatients

Hu Lin, Li Taoming, Dai Tingting, Zou Le, Yin Tao
2018, 20(2): 96-96. Full Text: PDF (850KB) (110)
»

Analysis of occurrence and risk factors of vancomycin-associated acute kidney injury in patients in the pediatric intensive care unit

Shen Xiaoju, Zeng Jiawei, Wu Haiyan, Chen Jie, Chen Xiao
2018, 20(2): 90-90. Full Text: PDF (1088KB) (137)
»

Severe lower gastrointestinal bleeding due to concomitant use of aspirin and ticagrelor

Du Qingqing, Wang Na, Liu Rui, Zhao Chunjing, Qian Yan, Zhao Li
2018, 20(4): 308-308. Full Text: PDF (487KB) (62)
»

Diclofenac sodium associated acute kidney injury

Ye Xiaolan, Zheng Xiaochun, Yang Xiuli, Zhang Guobing
2018, 20(2): 147-147. Full Text: PDF (301KB) (117)
»

Urinary incontinence caused by pioglitazone

Yang Wei, Tang Mingming, Suo Lixia
2018, 20(2): 153-153. Full Text: PDF (273KB) (60)
»

Toxic epidermal necrolysis caused by calcium dobesilate capsules: report of 2 cases

Gao Tingting, Qin Li, Zhou Xiaoyong
2018, 20(3): 230-230. Full Text: PDF (457KB) (98)
»

2018, 20(3): 163-163. Full Text: PDF (478KB) (157)
»

Clinical analysis of liver injury associated with edaravone in patients with acute ischemic stroke

Song Lipo, Wang Chunmei, Chu Yanqi, Ji Xunming, Duan Jiangang, Wei Libing, Ning Yachan, Huang Ying, Zhang Jian
2018, 20(3): 168-168. Full Text: PDF (721KB) (126)
»

Severe hypertension in a very-low-birth-weight infant caused by caffeine combined with cimetidine or erythromycin

Shen Xintian, Zhou Ping, Liang Xiaoqin, Chen Yu, Zhong Ming, Fan Xiaomei, Guo Huijuan
2018, 20(3): 234-234. Full Text: PDF (437KB) (52)
»

Hemoglobin reduction due to cefoperazone sodium and sulbactam sodium

Yang Jing, Cui Xiangli, Yang Hui, Liu Lihong
2018, 20(2): 154-154. Full Text: PDF (291KB) (115)
»

#br# Design and preliminary application of pre-audit system for medical orders in hospitalized patients

Cui Xiaohui, Yan Suying, Jiang Dechun, Guo Jingxian, Zhang He, Liang Zhigang, Fei Xiaolu, Yan Bing, Kong Fancui, Li Lingfeng
2018, 20(2): 127-127. Full Text: PDF (957KB) (92)
»

Fanconi′s syndrome induced by adefovir dipivoxil

Song Yu, Lu Ya, Yang Xueqin, Kang Xuan, Wang Qi, Shen Huiqin
2018, 20(2): 141-141. Full Text: PDF (299KB) (101)
»

Drug-induced liver failure: clinical analysis of 108 cases

Wang Lijun, Zhan Hanqiu
2018, 20(3): 175-175. Full Text: PDF (1099KB) (125)
»

2018, 20(2): 156-156. Full Text: PDF (319KB) (53)
»

Anaphylactic shock associated with cisatracurium esilate

Wang Ye, Huang Bing
2018, 20(2): 149-149. Full Text: PDF (308KB) (78)
»

Suspected serotonin syndrome induced by fentanyl

Yan Xuelian, Xu Linlin, Mei Dan, Ge Nan
2018, 20(2): 146-146. Full Text: PDF (446KB) (104)
»

Analysis on acute kidney injury and its risk factors in very elderly patients after urologic surgery

Shen Jianghua, Zhao Simiao, Yan Suying
2018, 20(2): 102-102. Full Text: PDF (893KB) (46)
»

Safety of dapagliflozin in Asian patients with type 2 diabetes mellitus: a Meta-analysis

Fang Zhenwei, Shi Jia, Shi Xiujin, Tang Huilin, Lin Yang
2018, 20(3): 209-209. Full Text: PDF (1617KB) (52)
»

Effects of escitalopram on coagulation function in epression patients

Shen Zhongxia, Zhang Xiaomei, Cai Min, Gen Song, Zhang Zhen, Yang Shengliang, Shen Xinhua
2018, 20(2): 121-121. Full Text: PDF (716KB) (61)
»

Hyperbilirubinemia induced by bosentan

Wang Ping, Zhang Wen, Zhao Yong, Zeng Yan
2018, 20(2): 143-143. Full Text: PDF (297KB) (81)
»

Mechanisms, characteristics, prevention and treatment of drug-induced peripheral neuropathy

Han Peng, Zhu Shenyin
2018, 20(2): 134-134. Full Text: PDF (1156KB) (86)
»

Liu fang, Zhang Xiaole, Zhu Zhu
2018, 20(5): 323-323. Full Text: PDF (482KB) (194)
»

orrelation between sodium-glucose co-transporter protein 2 inhibitors and fracture risk in patients with type 2 diabetes mellitus: a Meta-analysis

Zhao Zinan, Liang Liang, Sun Xuelin, Zhu Yuanchao, Feng Yufei, Zhang Yatong
2018, 20(2): 116-116. Full Text: PDF (981KB) (60)
»

Overcoming clinical inertia, improving the management of anticoagulation therapy

Hua Lu, Jing Zhicheng
2018, 20(4): 244-244. Full Text: PDF (654KB) (85)
»

Coagulation disorders due to ceftriaxone sodium for injection

Chen Weizhi
2018, 20(5): 399-399. Full Text: PDF (289KB) (113)
»

Alteplase-induced anaphylaxis accompanied with peripheral hematoma in a patient with acute cerebral infarction

Zhou Jingliang, Guan Xiaodong, Wu Xinjing, Peng Binbin
2018, 20(3): 227-227. Full Text: PDF (313KB) (96)
»

Hu Lihua, Meng Yao, Wang Xiaoling
2018, 20(5): 328-328. Full Text: PDF (822KB) (120)
»

Analysis on reports of medication errors with methotrexate tablets in National Monitoring Network for Clinical Safe Medication from 2012 to 2017

Zhang Qingxia, Yan Suying, Li Xiaoling, Zeng Yan, Wang Yuqin
2018, 20(3): 192-192. Full Text: PDF (942KB) (48)
Adverse Drug Reactions Journal
 Top Download
»

Rapid-progressive decrease of cognitive and physical functions due to rituximab

Li Jinfeng, Yan Xiujuan, Zhang Jinbiao, Zhang Yuan
2015, 17(3): -. Full Text: PDF (454KB) (43224)
»

2015, 17(2): 103-103. Full Text: PDF (497KB) (36339)
»

Adverse drug reactions induced by long term use of proton pump inhibitors

Si Xiaobei, Lan Yu
2015, 17(3): -. Full Text: PDF (608KB) (36298)
»

Attention to adverse reactions of longterm proton pump inhibitors therapy

Wang Shujun;Qian Jiaming
2015, 17(1): 2-2. Full Text: PDF (312KB) (33922)
»

Development of a list of potentially inappropriate medication for the Chinese aged people

Yan Yan;Wang Yuqin;Shen Qian;Jiang Dechun;Li Xiaoling;Liu Chen;Li Xingwei
2015, 17(1): 8-8. Full Text: PDF (1208KB) (27355)
»

Analysis on lansoprazole-induced microscopic colitis in 62 patients

an Guobao;Lei Zhaobao
2015, 17(1): 4-4. Full Text: PDF (581KB) (19227)
»

Hematuria due to concomitant use of low dose clopidogrel and aspirin

Liu Jun;Zhu Yanhong
2015, 17(1): 2-2. Full Text: PDF (279KB) (10930)
  News
  Links
22 Links
Copyright © Adverse Drug Reactions Journal