我院同一药品多发药品不良反应/事件报告分析

Analysis of Multiple ADR/ADE Reporting Induced by Same Drug in Our Hospital

目的:探讨同一药品多发药品不良反应/事件(ADR/ADE)的原因、影响因素,为临床用药及药品群体不良事件的防范提供参考。方法:采用回顾性方法,对我院2005年8月至2011年8月短期内(30d)同一药品出现2例以上相同ADR的报告35例(共10起ADE),以患者的性别、年龄、ADR累及器官或系统、临床表现、出现ADR原因初步分析及构成比等进行统计。结果:35例ADR报告中治愈率达100%,未发现有后遗症。ADR累及器官或系统损害以中枢神经系统最多(占30.23%)。报告原因分析有50.00%是换用新批号或新生产厂家药品后出现的,根据情况做了停药、退换货等处理;33.33%是由于药品使用问题导致,根据临床需要,给予用药指导或更换为适宜的药品。结论:基层ADR监测人员应严格执行《ADR报告和监测管理办法》,这是减少ADR、防范药品群体不良事件的重要保证。

OBJECTIVE ： To investigate the reasons and influential factors of multiple ADR/ADE induced by same drug, and to provide reference for clinical drug use and adverse events of drug groups. METHODS ： By retrospective study, a total of 35 ADR and 10 ADE cases, which occurred at short time （during 30 days） by same drug and happened more than twice, collected in our hospital from Aug. 2005 to Aug. 2011 were analyzed in respect of the patient＇ s gender and age, organs or systems involved in ADR and clinical manifestation, original reasons and constituent ratio, etc. RESULTS： Among 35 ADR reports, cure rate was 100% , and sequela was not found; organs or systems involved in ADR mostly was central nervous system （accounting for 30.23% ） ; 50.00% appeared after using drugs of new batch or new manufacturers, and drug withdrawal, returns and other processing were carried out according to the situation; 33.33% was caused by drug use, and medication guidance and suitable change were performed according to clinical demand. CONCLUSIONS： Drug Reaction Reporting and Monitoring Management Approach, Primary ADR monitoring staffs should strictly implement Adverse which is important to reduce ADR and prevent group ADE.