甲硝唑注射液致不良反应/不良事件413例报告分析

Analysis of 413 Reports of ADR/ADE Induced by Metranidazole Injection

目的:探讨甲硝唑注射液致不良反应(ADR)/不良事件(ADE)的一般规律及特点,为临床合理用药提供参考。方法 :采用回顾性研究方法,检索河南省ADR监测中心2014年1月1日-12月31日收到的甲硝唑注射液致ADR/ADE病例报告,并就收集到的413例ADR/ADE相关信息进行统计和分析。结果 :甲硝唑注射液致ADR/ADE与性别有关,以中老年女性患者居多(88.37%);用药30 min内可发生ADR/ADE;临床表现主要以胃肠系统损害、皮肤及其附件损害、中枢及外周神经系统损害较为多见;部分患者可出现心悸、心动过速等心脏毒性反应,但甲硝唑注射液说明书中未有致心脏毒性反应的风险提示。结论 :临床应加强对甲硝唑注射液致ADR/ADE的观察,特别是对心脏毒性反应的监测;药品生产企业应完善药品说明书并明确其用药风险,以确保临床用药安全。

OBJECTIVE：To explore the general pattern and characteristics of ADR/ADE induced by Metranidazole injection,and provide reference for clinical treatment. METHODS：Retrospective study was used to retrieve the ADR/ADE reports induced by Metranidazole injection from Jan. 1 to Dec. 31,2014 in ADR Monitoring Center of Henan Province,and the related information of 413 ADR/ADE reports were statistically analyzed. RESULTS：ADR/ADE induced by Metranidazole injection was related to gender,they were mainly middle-age and elderly female patients（88.37%）,and ADR/ADE may occurred within 30 min;the main clinical manifestations were gastrointestinal system damage,skin and appendages damage,central and peripheral nervous system damage,parts of patients showed palpitations,tachycardia and other cardiac toxicity reactions,and Metronidazole Injection instruction had no risk warning. CONCLUSIONS：Clinic should strengthen the observation of ADR/ADE induced by Metranidazole injection,especially the monitoring of cardiac toxicity reactions;pharmaceutical manufacturers should improve the drug instructions and clear medication risks to ensure the safety of clinical medication.