曲美他嗪口服制剂致不良反应/事件768例分析  

Analysis of 768 ADR/ADE Induced by Trimetazidine Oral Preparations

作　　者：李文武[1] 夏旭东[1] 王丽[1] 杨雪[1] 张惠霞[1] 陈超[1] 

机构地区：[1]河南省食品药品评价中心,郑州450004

出　　处：《中国药房》2014年第4期366-368,共3页China Pharmacy

摘　　要：目的:探讨曲美他嗪(TMZ)口服制剂致不良反应/事件(ADR/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,对2004年1月-2012年7月期间河南省药品不良反应监测中心数据库中768例TMZ口服制剂致ADR/ADE报告的相关情况进行统计和分析。结果:ADR/ADE多发生在用药3 d以内,共573例(占74.61%);累及器官/系统主要为胃肠系统(740例次,占70.21%)、皮肤及其附件(149例次,占14.13%)、中枢及外周神经系统(77例次,占7.31%)等,其中包括震颤7例次、运动障碍1例次和舌麻痹1例次;5例严重ADR/ADE表现为剥脱性皮炎、局部僵硬、呼吸困难、潮红、口干、外周水肿等;联合用药111例(占14.45%),联用品种主要为心血管系统用药;经停药或治疗后760例(占98.96%)好转或治愈。结论:该省数据库中TMZ口服制剂致ADR/ADE大多为已知的ADR/ADE。建议加强对TMZ口服制剂致ADR/ADE的监测,完善国内企业药品说明书,提高临床合理用药水平,减少ADR/ADE的发生。OBJECTIVE： To provide reference for rational drug use by investigating the general regulation and characteristics of ADR/ADE induced by Trimetazidine oral preparations. METHODS： By retrospective study, 768 cases of ADR/ADE induced by Trimetazidine oral preparations in Henan Provincial Center for ADR Monitoring during Jan. 2004--Jul. 2012 were analyzed statistically. RESULTS： ADR/ADE mostly occurred within first 3 days of medication, involving 573 cases （accounting for 74.61% ）. Organs or systems involved in ADR/ADE were mainly stomach and intestinal system （740 eases, 70.21% ）, skin and its appedants （149 cases, 14.13%）, central and peripheral nervous system （77 cases, 7.31%）. Among all the cases, 7 cases suffered from tremors, 1 case with dyskinesia, and 1 case with glossoplegia; 5 cases of severe ADR/ADE manifested as Exfoliative dermatitis, local stiffness, dyspnea, flushing, dry mouth and peripheral edema. There were 111 cases of drug combination （14.45%）, and the most variety was cardiovascular medicines. 760 cases were improved or cured after drug withdrawal or treatrnent（98.96% ）. CONCLUSIONS ： The ADR/ADE induced by Trimetazidine oral preparations in Henan ADR monitoring database have been acknowledged. It is suggested to strengthen ADR/ADE monitoring induced by Trimetazidine oral preparations, and improve the drug instruction, in order to improve rational dru~ use and reduce the incidence of severe ADR/ADE.

关 键 词：曲美他嗪 不良反应 事件 分析 

分 类 号：R969.3[医药卫生—药理学]