806例严重药品不良反应/事件回顾性分析

Retrospective Analysis of 806 Cases of Severe Adverse Drug Reactions/Events

目的:分析严重药品不良反应/事件(ADR/ADE)报告的发生规律和特点,为临床合理用药提供信息。方法:对806例严重ADR/ADE报告进行汇总,分别从患者性别、药品种类、年龄、累及系统-器官、给药途径及不良反应转归等方面进行统计分析。结果:严重ADR/ADE患者中女性与男性比例为1∶0.91,≥60岁患者占比69.98%。涉及药品品种例次最多的为抗感染药物、中药成方和肿瘤用药(分别占比37.20%、12.40%和9.92%)。严重ADR/ADE给药途径以静脉给药为主,累及系统-器官主要表现为皮肤及附件损害,全身性损伤及心血管系统。结论:应加强抗感染药、中药制剂及抗肿瘤用药的监测,尤其加强注射制剂及重点人群的用药监测。

Objective:The occurrence and characteristics of severe adverse drug reactions(ADR/ADE)were analyzed,to provide information for rational drug use in clinic.Methods:The reports of 806 severe ADR/ADE cases were summarized,statistical analysis was carried out from such aspects patient gender,drug type,age,systemic involvement-organ involvement,route of administration and outcome of adverse drug reactions.Results:The ratio of women to men in severe ADR/ADE was 1∶0.91,percentage of patients 60 or older69.98%.The most common drugs involved were anti-infective drugs,prescription of traditional Chinese medicine and administration of Tumor Drugs(respective share 37.20%,12.40%,9.92%).Ntravenous administration is the main route of administration,serious ADR/ADE involved the system-organ mainly showed skin and appendage damage,general injury and the cardiovascular system.Conclusion:Surveillance of anti-infective agents,traditional Chinese medicine preparation and antineoplastic drugshould be strengthened,in particular,to strengthen the injection preparations and key populations of drug monitoring.