托哌酮上市后在我国人群中的安全性再评价  

Re-evaluation of Post-marketing Safety of Tolperisone in China

作　　者：李文武[1] 王丽[1] 卢洁[2] 郭慧[1] 张惠霞[1] 刘超[1] 

机构地区：[1]河南省食品药品评价中心,郑州450004 [2]郑州大学公共卫生学院,郑州450001

出　　处：《中国药房》2013年第44期4195-4197,共3页China Pharmacy

摘　　要：目的:了解中国人群中托哌酮致不良反应/不良事件(ADR/ADE)尤其是超敏反应的发生特点及规律,为临床合理用药提供依据。方法:回顾性分析河南省药品不良反应监测数据库中托哌酮病例报告数据;计算机检索PubMed、EMbase、Cochrane临床对照试验资料库、中国生物医学文献数据库、中国期刊全文数据库、维普数据库、万方数据库中有关托哌酮治疗中国人群引起ADR/ADE的文献并作系统评价。结果:河南省药品不良反应监测数据显示,托哌酮致ADR/ADE主要累及中枢及外周神经系统损害(38.50%)、胃肠系统损害(30.23%)、皮肤及其附件损害(12.66%)等,临床主要表现为头晕、腹痛、嗜睡、乏力、潮红、厌食等。系统评价最终纳入2篇有关服用常规剂量托哌酮致ADR/ADE的文献,一篇报告2例患儿出现嗜睡症状,另一篇报告1例55岁男性出现瘙痒、荨麻疹等过敏反应症状。结论:托哌酮在中国人群中的ADR/ADE大多为说明书中已记载的,且少见有欧洲药品管理局(EMA)提到的超敏反应。建议加强对托哌酮致ADR/ADE的监测,进一步开展大规模、多中心、随机对照的临床试验,以确保公众临床用药安全。OBJECTIVE： To investigate the characteristics and regulations of adverse drug reaction/event （ADR/ADE） in Chinese, especially the hypersensitivity, and to provide reference for rational drug use in the clinic. METHODS： All ADR/ADE reports of tolperitone collected by Henan ADR monitoring database were analyzed retrospectively. All literatures about tolperisone-induced ADRJADE were retrieved from PubMed, EMbase, Cochrane Central Database, CBM, CNKI, VIP and Wanfang database, and meta-analysis were performed. RESULTS： Henan ADR monitoring data suggested that the main tolperisone-induced ADRs/ ADE were central and peripheral nervous system injury （38.50%）, gastrointestinal system damage （30.23%） and lesion of skin and its appendents （12.66%）. The observed clinical features included dizziness, abdominal pain, drowsiness, fatigue, flusing, anorexia, etc. Whereas, literature reviewing found 2 literatures about common dosage tolperisone induced ADRs, a literature about 2 children suffering from drowsiness and other one literature about adult male aged 55 suffering from pruritus and urticaria. CONCLUSIONS： The ADR/ADE induced by tolperisone among Chinese population have been almost recorded in the instruction, and there are less occurrence frequency in hypersensitivity ADRs which were reported by EMA. Thus, it is suggested to upgrade tolperisone-induced ADR/ADE monitoring and develop large-scale multiple center randomized-controlled clinical trials, in order to ensure the safety of national clinical drug use in China.

关 键 词：托哌酮 上市后 不良反应 不良事件 评价 

分 类 号：R969.3[医药卫生—药理学]