829例严重药品不良反应/事件报告分析

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种占居首位（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。

Analysis on 829 Serious Adverse Drug Reaction/Event Reports

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 .