利巴韦林儿童应用风险分析与建议  

Analysis and Suggestions on Risk of Ribavirin in Children

作　　者：李清芳 刘欢 张丹丹 杨悦[3,4] 张惠霞[5] 夏旭东[5] 刘超[5] LI Qing-fang;LIU Huan;ZHANG Dan-dan;YANG Yue;ZHANG Hui-xia;XIA Xu-dong;LIU Chao(Kaifeng Institute of Food and Drug Control, Henan Kaifeng 450000, China;Center for ADR Monitoring of Kaifeng, Henan Kaifeng 450000, China;School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;International Food & Drug Policy and Law Research Center, Liaoning Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;Henan Food and Drug Evaluation Center, Henan Zhengzhou 450018, China)

机构地区：[1]开封市食品药品检验所,河南开封475000 [2]开封市药品不良反应监测中心,河南开封475000 [3]沈阳药科大学工商管理学院,辽宁沈阳110016 [4]沈阳药科大学国际食品药品政策与法律研究中心,辽宁沈阳110016 [5]河南省食品药品评价中心,河南郑州450018

出　　处：《中国药物警戒》2018年第2期83-89,共7页Chinese Journal of Pharmacovigilance

摘　　要：目的通过比较国内外利巴韦林批准情况及药品说明书等,并对某省利巴韦林儿童药品不良反应(ADR)报告数据挖掘,分析我国儿童利巴韦林临床应用风险来源,以期为该药说明书修改、临床应用及监管等提供建议。方法比较分析国内外利巴韦林批准信息、使用情况及药品说明书;采用回顾性方法对某省2003年1月至2016年12月利巴韦林儿童ADR报告数据分析。结果国内外利巴韦林批准剂型、适应证差异明显,我国利巴韦林儿科临床应用中联合用药不当、超适应证使用等不合理用药现象严重。结论建议修订完善药品说明书,对利巴韦林未批适应证和未批剂型予以关注,规范其儿科临床应用。Objective Through comparatively analyzing the approval,application and instructions of ribavirin at home and abroad,to conduct the risk analysis of domestic children ribavirin clinical use based on the ribavirin's children ADR report data in a certain province,so as to provide suggestions on the modification of instructions,clinical application,regulation and so on.Methods The risk of ribavirin was analyzed by means of comparing ribavirin's approval,application and instructions at home and abroad,and analyzing ribavirin's children ADR reports collected by a certain province from January2003to December2016.Results The approval and application of ribavirin were different significantly between China and abroad,the phenomenons of irrational drug combination and off-label use are common during clinical application in children.Conclusion It is suggested that regulatory authority,manufactures and healthcare providers should pay attention to unapproved indications and dosage form of ribavirin,while revising and improving instruction for more standardized application.

关 键 词：利巴韦林 批准及使用 说明书比较 风险分析 儿童 

分 类 号：R994.11[医药卫生—毒理学]