甲硝唑致心脏损害58例不良反应/事件分析

摘要

OBJECTIVE:To explore the characteristics and regularities of cardiac damage induced by metranidazole,and pro-vide reference for clinical safe application. METHODS:In retrospective study,58 cases of cardiac damage caused by metranidazole in Henan ADR Monitoring Center for Drug from Jan. 2010 to Dec. 2015 were analyzed statistically. RESULTS:In 58 cases of cardiac damage induced by metranidazole,25 cases were male,33 were female,the ratio of male to female was 0.76∶1,the patients with ADR/ADE aged 15-64 years (74.14%),most were intravenous administration (79.31%) and happened within 30 min (70.69%), cardiac damage mainly manifested as palpitation,severe cases can cause tachycardia and arrhythmia,the ADR improved or cured af-ter withdrawal or symptomatic treatment. CONCLUSIONS:Clinic should strengthen observation of ADR/ADE caused by metranida-zole,especially the monitoring of cardiac toxicity reactions;pharmaceutical manufacturers should improve the drug instructions to in-sure the safety of clinical medication.%目的：探讨甲硝唑致心脏损害的特点和规律，为临床安全用药提供参考。方法：采用回顾性研究方法，对河南省药品不良反应（ADR）监测中心2010年1月－2015年12月收到的58例甲硝唑致心脏损害的报告进行分析。结果：58例甲硝唑致心脏损害病例中，男性25例，女性33例，男女比例为0.76∶1；发生ADR/药品不良事件（ADE）患者年龄以15～64岁为主（74.14％）；静脉给药途径最多见（79.31％）；发生在30 min内居多（70.69％）；主要表现为心悸，严重者可致心动过速和心律失常；58例患者经停药或对症治疗后ADR均好转或痊愈。结论：临床应加强对甲硝唑致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，以确保临床用药的安全。