3062例基本药物不良反应/事件报告分析

Analysis of 3062 Cases of Adverse Drug Reaction/Event Reports

目的：探讨基本药物不良反应／事件（ ADR／ADE）的发生特点和一般规律，为促进临床安全用药提供参考。方法：对马鞍山市2013年收集的3062例药品不良反应报告作回顾性分析，分别按报告类型、患者性别、年龄、药品种类、剂型、给药途径、ADR／ADE累及系统-器官等项目统计并分析。结果：3062例ADR／ADE报告中，新的严重的不良反应24例（0.78％）；40～49岁、50～59岁、60～69岁3个年龄段ADR／ADE构成比居于前三位；性别比例基本相当；引起ADR／ADE的药物以抗感染药物最多（46.57％）；剂型分布以注射剂（50.88％）和片剂（29.26％）为主；给药途径以静脉注射引发ADR／ADE 最多，共1726例（56.37％）；ADR／ADE累及的系统器官以皮肤及附件最多见（34.13％）。结论：提示临床应用中应进一步加强基本药物重点监测及高发群体不良反应的监控，尽可能减少ADR／ADE的发生。

Objective：In order to provide references for accelerating the clinical safe medication , we analyzed the characteristics and general regulation of adverse drug reaction/event （ ADR/ADE）.Methods：3062 cases of adverse drug reactions reported were studied retrospectively in Ma′anshan area of 2013.The statistical analysis was performed separately by report type , sex of the patients , types of ADR/ADE, drug varieties , dosage form , route of administration , and ADR/ADE involving organ/system.Results：There were 24 new and serious ADR/ADE cases （0.78%）of 3062 ADR/ADE cases.40 to 49, 50 to 59 and 60 to 69 age groups lay in the top three of ADR/ADE constituent ratios.The ratio of male to female was almost equal; most ADR/ADE caused by anti-infectives accounts for 46.57%.The most dosage form was injection （50.88%） and tablets （29.26%）, and intravenous drip occupied the main route of ad-ministration of ADR/ADE and the number is 1,726 cases （56.37%）.The skin and its appendages damage was the major clinical mani-festations, accounting for 34.13%.Conclusion： Adverse drug reactions monitoring should be further strengthened especially on the group with high incidence to reduce the occurrence of ADR /ADE as far as possible .