甲巯咪唑药品不良反应/事件文献分析  

Literature Analysis of Adverse Drug Reactions/Events Induced by Thiamazole

作　　者：彭丽丽[1] 刘巍[1] 汤韧[1] 李岚[1] 范燕[1] PENG Lili;LIU Wei;TANG Ren;LI Lan;FAN Yan(Centre for Drug Reevaluation,CFDA,Beijing 100045,China)

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国药物警戒》2018年第7期404-410,共7页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项项目(2017ZX09101001-001-003):药品再评价政策法规及实施策略研究

摘　　要：目的分析甲巯咪唑不良反应/事件文献,为临床合理用药提供参考。方法通过检索2009—2017年Pubmed、Embase、中国知网(CNKI)、万方医学网数据库,采用循证医学和情报学原理,对收录的甲巯咪唑不良反应/事件文献进行筛选和分析。结果临床应用文献117篇,涉及病例449例;女性患者数量为男性的4.80倍,15~44岁青壮年期患者居多,严重不良反应主要为血液系统损害和肝胆系统损害,构成比分别为48.12%和22.26%。结论应加强甲巯咪唑的临床应用监测,规范和完善药品说明书,促进药品的合理应用。Objective To investigate and analyze the literatures on clinical application and ADR/ADE induced by thiamazole,so as to provide reference for its rational use in clinic.Methods The literatures for the clinical application and ADR/ADE of thiamazole were retrieved in the databases of Pubmed,Embase and CNKI,Wangfang data.The related literatures were screened out and analyzed by evidence-based medicine method and bibliometric statistical method.Results 117 available literatures were retireved;449 adverse drug reaction cases were collected.Female patients were 4.80 times that of male patients,the most of patients were 15 to 44 years old,the serious adverse drug reactions(events)were mainly blood system damage and hepatobiliary disorders,accountiong for 48.12%and 22.26%respectively.Conclusion We should reinforce the clinical application monitoring of thiamazole,standardize and improve the drug manual,promte the rational application of drug.

关 键 词：甲巯咪唑 临床应用 粒细胞缺乏症 肝损害 药品不良反应/事件 

分 类 号：R994.11[医药卫生—毒理学]