中国药物警戒 ›› 2010, Vol. 7 ›› Issue (4): 234-236.

• 药品不良反应监测 • 上一篇    下一篇

168例药品不良反应/事件报告分析

王会容   

  1. 四川省绵阳市中医院药剂科,四川 绵阳 621000
  • 收稿日期:2016-02-19 修回日期:2016-02-19 出版日期:2010-04-08 发布日期:2016-02-19
  • 作者简介:王会容,女,主管药师,临床药学。

Analysis of 168 Adverse Drug Reaction/Event Reports

WANG Hui-rong   

  1. Department of Pharmacy Mianyang T.C.M. Hospital of Sichuan, Sichuan Mianyang 621000, China
  • Received:2016-02-19 Revised:2016-02-19 Online:2010-04-08 Published:2016-02-19

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摘要： 目的 了解药品不良反应/事件发生的特点及一般规律,为临床安全、合理用药提供参考;评价药品不良反应/事件报告表填写质量。方法 对我院2007年1月~2009年6月收集到的168例药品不良反应/事件报告进行回顾性分析。结果 168例药品不良反应/事件涉及104种药品,其中抗感染药物居首位（占45.2%）,其次是中药制剂（占25.6%）;给药途径以静脉滴注所占比例最大（占61.9%）;临床表现以皮肤及其附件损害最常见（38.6%）;严重不良反应/事件有4例;绝大多数药品不良反应/事件出现在用药61分钟至24小时内（112例）;对症治疗52例,未进行特殊处理的60例。我院药品不良反应/事件报告总数偏少,报告表填写质量较差。结论 应加强药品不良反应监测和报告,确保临床安全、有效、合理用药。抗感染药、中药制剂的应用及静脉用药的给药方式是药品不良反应/事件发生的主要因素,应加强其使用的监督管理。

关键词: 药品不良反应/事件, 报告分析, 合理用药

Abstract: Objective To investigate the features and general pattern of the adverse drug reaction/event(ADR/ADE), and provide references of clinical rational and safty use of drug and evaluate the quality of ADR/ADE reports. Methods A total of 168 ADR/ADE cases collected in our hospital from Jan.2007 to June 2009 were analyzed retrospectively. Results A total of 104 drugs were involved in the 168 ADR/ADE,mainly anti-infective drugs(45.2%), followed by Traditional Chinese Medicines(25.6%). The main route of administration was by intravenous drip(61.9%). The ADR/ADE were chiefly characterized by the lesions of skin and appendages(46.4%). There were four severe cases and most of ADR/ADE occurred within 24 hours after medication(112 cases); 52 cases were given symptomatic treatment and 60 cases were left untreated. The number of ADR/ADE reports was less than expected and the quality of ADR/ADE reports was poor. Conclusion ADR monitoring and reporting should be strengthened to ensure safe, effective and rational drug use in the clinic. The ADR/ADE occurred in our hospital were mainly induced by the use of anti-infectives and Chinese materia medica preparation administered by intravenous drip. Measures should be taken to tighten control on rational drug use.

Key words: adverse drug reaction/event(ADR/ADE), analysis of reports, rational use of drugs

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