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134例严重药品不良反应/事件报告分析
Analysis of 134 Cases of Serious Adverse Drug Reactions/Events
  
DOI:
中文关键词:  药品不良反应  药品不良事件  报告  监测  用药安全
英文关键词:Adverse drug reactions  Adverse drug events  Report  Monitoring  Drug safety
基金项目:
作者单位
陈思颖 尤海生 朱亚宁 何云 董亚琳 王茂义 ①西安交通大学医学院第一附属医院药学部(西安 710061)②陕西省人民医院药学部③西安交通大学医学院第一附属医院急诊科 
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中文摘要:
      摘 要 目的:分析西安交通大学第一附属医院严重药品不良反应/事件(ADR/ADE)发生的原因及特点,为临床合理用药提供参考。方法:汇总统计该院2008~2015年134例严重药品不良反应/事件报告,分别从患者年龄、性别、药品种类、临床表现、给药途径及关联性评价等方面进行统计与分析。结果:发生严重ADR/ADE患者的男女比例为1.13∶1,老年人患者、涉及抗肿瘤药物和抗菌药物ADR/ADE的构成比分别为37.31%、37.31%和22.39%。报告例次最多的15个药品中,抗肿瘤药物8种,抗菌药物3种。静脉滴注发生ADR/ADE构成比85.4%。严重ADR/ADE的临床表现主要以全身性损害、血液系统损害和心血管损害多见。结论:重视抗肿瘤药物和抗菌药物ADR/ADE的监测,提高临床安全、有效、合理的用药水平,降低临床ADR/ADE风险,保障患者的用药安全。
英文摘要:
      ABSTRACT Objective:To analyze the reasons and characteristics of serious adverse drug reactions (ADR)/adverse drug events (ADE) in The First Affiliated Hospital of Xi’an Jiaotong University, and provide reference for clinical rational drug use.Methods: All the clinical data were collected from 134 cases of serious ADR/ADE from 2008 2015 in the hospital. It was statistically analyzed from patients’ age, sex, types of drugs, clinical manifestations, the route of administration and the relevance of evaluation. Results:The proportion of men and women in serious ADR/ADE patients was 1.13∶1, the occurrence rate of serious ADR/ADE in elderly patients, anti tumor drugs and antimicrobial drugs were 37.31%, 37.31% and 22.39%, respectively. There were eight kinds of anti tumor drugs and three kinds of antimicrobial drugs in the 15 drugs of most frequently reported cases. The constituent ratio of intravenous infusion occurred ADR/ADE was reached to 85.4%. Clinical manifestations of serious ADR/ADE were mainly systemic damage, blood system damage and cardiovascular damage. Conclusion:We should pay attention to the monitoring of ADR/ADE of anti tumor drugs and antimicrobial drugs, improve the clinical safe, effective and rational use of drugs, reduce the risk of clinical ADR/ADE and ensure the drug safety of patients.
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