CFDA发布的药品不良反应信息通报中儿童用药典型病例分析  

Typical Case Analysis of Children's Medication in Adverse Drug Reaction Information Bulletin of CFDA

作　　者：赵瑞玲[1] 张占慧 张冠东[1] ZHAO Rui-ling;ZHANG Zhan-hui;ZHANG Guan-dong(Children's Hospital of Shanxi, Shanxi Taiyuan 030013 China;Shanxi Medical University, Shanxi Taiyuan 030001 China)

机构地区：[1]山西省儿童医院,山西太原030013 [2]山西医科大学,山西太原030001

出　　处：《中国药物警戒》2018年第2期121-124,共4页Chinese Journal of Pharmacovigilance

基　　金：山西省卫生厅科研课题(20130142):医院药学实践对儿童用药安全性的影响

摘　　要：目的分析国家食品药品监督管理局(CFDA)网站发布的药品不良反应信息通报中儿童安全用药信息,促进儿童临床合理用药。方法查询CFDA网站2001年11月19日至2017年1月5日发布的药品不良反应信息通报,提取有关儿童安全用药信息。结果共报道了40例儿童用药导致药品不良反应/事件的典型病例,其中一般药品不良反应/事件25例,占62.50%(25/40),严重药品不良反应/事件15例,占37.50%(15/40)。抗感染药物数量最多19例,占47.50%(19/40)。40例儿童用药导致药品不良反应/事件典型病例中,不合理用药高达75.00%。结论需进一步呼吁全社会高度关注儿童安全用药,加强各级医务人员儿童合理用药培训和管理,从政策和法规层面解决儿童用药问题。Objective To analyze the information of children's safe medication in Adverse Drug Reactions Information Bulletin published by China Food and Drug Administration(CFDA)website,and promote the rational use of medicines in children.Methods Check the information of adverse drug reactions released by CFDA website from November19,2001,to January5,2017,and extract information about the children's safe medication.Results A total of40cases of adverse drug reactions/events in children were reported.Among them,there were25cases of adverse drug reactions/events,accounting for62.50%(25/40),and15cases of serious adverse drug reactions/events,accounting for37.50%(15/40).The number of anti-infective drugs was up to19cases,accounting for47.50%(19/40).In the40cases of adverse drug reactions/events,the unreasonable drug use was up to75.00%.Conclusion It is necessary to call for the whole community to pay close attention to children's safe medication,to strengthen the children's rational drug use training and management for medical staff at all levels,and to solve the problem of children's medication from the policy and legal level.

关 键 词：儿童 安全用药 药品不良反应 药品不良事件 

分 类 号：R994.11[医药卫生—毒理学]