中国药物警戒 ›› 2010, Vol. 7 ›› Issue (11): 686-689.

• 药品不良反应监测 • 上一篇    下一篇

829例严重药品不良反应/事件报告分析

江腊梅,刘武,肖佳   

  1. 济南市药品不良反应医疗器械不良事件监测中心,山东济南 250001
  • 收稿日期:2016-03-09 修回日期:2016-03-09 出版日期:2010-11-08 发布日期:2016-03-09
  • 作者简介:江腊梅,女,主任药师,药品不良反应监测。

Analysis on 829 Serious Adverse Drug Reaction/ Event Reports

JIANG La-mei ,LIU Wu ,XIAO Jia   

  1. Jinan Adverse Drug Reactions /Adverse Event Monitoring Centre, Shandong Jinan 250001
  • Received:2016-03-09 Revised:2016-03-09 Online:2010-11-08 Published:2016-03-09

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摘要： 目的 了解严重药品不良反应/ 事件（ADR/ADE）发生的特点及规律,为临床安全、有效、合理用药提供参考。方法 对济南市2009 年收集到的829 例严重ADR/ADE 报告数据进行回顾性统计分析。结果 829 例严重ADR/ADE病例中涉及273 种药品,其中抗微生物药品77 种,居首位（占44.75%）；涉及国家基本药物75 种（占27.47%）,其中严重ADR/ADE 病例270 例（占32.57%）；给药途径以静脉滴注所占比例最大（占78.04%）；严重ADR/ADE 主要临床表现为过敏性休克（占8.56%）、呼吸系统、全身性损害以及中枢神经系统。结论 加强严重ADR/ADE 监测工作,确保临床安全、有效、合理用药。

关键词: 严重的, 药品不良反应/事件, 病例分析, 合理用药

Abstract: Objective To understand the serious adverse drug reactions/events(ADR/ADE) occurred in the characteristics and rules for clinical safe, effective and rational use of available information. Methods of Jinan City in 2009 collected 829 cases of serious ADR/ADE reports were retrospectively analyzed the data. Results 829 cases of serious ADR/ADE involving 273 drugs, which occupies the first anti-microbial drugs(accounting for 44.75%); involving 75 varieties of national essential drugs( accounting for 27 .47 % ) , in which serious ADR/ ADE cases , 270 cases ( accounting for 32.57%); route of administration by intravenous infusion of the largest proportion (accounting for 78.04% ); serious ADR/ADE main clinical manifestations of anaphylactic shock(accounting for 8.56%), respiratory, systemic and central nervous system damage. Conclusion strengthening serious ADR/ADE monitoring, to ensure clinical safety, effective, rational use of drug.

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

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