829例严重药品不良反应/事件报告分析

Analysis on 829 Serious Adverse Drug Reaction/Event Reports

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。

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 .