抗癫痫药品说明书中孕妇及哺乳期妇女用药信息的标注统计分析  

Statistical analysis of medication information labeling of pregnant women and lactating women of anti-epileptic drug instructions

作　　者：张涛[1] 胡晨吉 陈鹏霖 陈丹[1] 金朝辉[1] ZHANG Tao;HU Chenji;CHEN Penglin;CHEN Dan;JIN Zhaohui(Department of Clinical Pharmacy,West China Hospital,Sichuan University,Sichuan Province,Chengdu 610041,China)

机构地区：[1]四川大学华西医院临床药学部,四川成都610041

出　　处：《中国医药导报》2024年第36期189-193,共5页China Medical Herald

摘　　要：目的统计分析孕妇及哺乳期妇女在我国上市的常见的抗癫痫药物说明书中用药信息的标注情况,为规范、合理使用抗癫痫药提供参考。方法收集常见抗癫痫药品说明书纸质版及丁香园官方网站中的“用药助手”记载的说明书作为参考,对抗癫痫药物说明书中孕妇和哺乳期妇女用药的标注进行分析,收集时间为2024年3月。结果本研究共纳入173份抗癫痫类药物说明书,160份有“孕妇用药”项标注,13份无“孕妇用药”项标注;154份有“哺乳期妇女用药”项标注,19份无“哺乳期妇女用药”项标注。统计173份药品说明书“孕妇用药”的指导意见标注,27份药品说明书无用药指导意见,146份药品说明书有用药指导意见。统计173份药品说明书“哺乳期妇女用药”的用药指导意见标注情况,28份无用药指导意见,145份有哺乳期妇女用药指导意见。统计14份国外药企药品说明书后发现,国外药品说明书均有列出“孕妇及哺乳期妇女用药”项,未注明“孕妇及哺乳期妇女用药”指导意见的药品说明书仅1份。结论目前国内抗癫痫药品说明书存在孕妇及哺乳期妇女用药标注项信息简单、内容缺失,以及用药推荐意见模糊等问题,为保障孕妇及哺乳期妇女的安全用药及为临床合理使用,建议相关部门进一步完善加强对药品说明书的规范及管理。Objective To make a statistical analysis of the labeling of drug information in the instructions of common anti-epileptic drugs for pregnant and lactating women listed in China,so as to provide reference for the standardized and rational use of anti-epileptic drugs.Methods The paper version of common anti-epileptic drug instructions and the instructions recorded in the“Drug Assistant”on the official website of Dingxiangyuan were collected as reference,and the labels of drugs used by pregnant and lactating women in the anti-epileptic drug instructions were analyzed.The collection time was March 2024.Results A total of 173 anti-epileptic drug instructions were included in this study,of which 160 were marked with“drug for pregnant women”and 13 were not marked with“drug for pregnant women”.There were 154 with the item“medication for lactating women”and 19 without the item“medication for lactating women”.Statistics of 173 drug instructions marked“pregnant women’s drug use”guidance,27 drug instructions did not have drug use guidance,146 drug instructions had drug use guidance.Statistics were collected for the labeling of drug guidance opinions on“drug use for lactating women”in 173 drug instructions,28 without drug guidance opinions and 145 with drug use guidance opinions for lactating women.After statistical analysis of 14 drug instructions of foreign pharmaceutical companies,it was found that foreign drug instructions all listed“drug use for pregnant and lactating women”,and only one drug instructions did not indicate the guidance of“drug use for pregnant and lactating women”.Conclusion At present,there are some problems in the instructions of anti-epileptic drugs for pregnant and lactating women,such as simple information,missing content,and vague recommendations on drug use.In order to ensure the safe use of drugs for pregnant and lactating women and rational clinical use,it is recommended that relevant departments further improve and strengthen the specification and management

关 键 词：孕妇 哺乳期妇女 抗癫痫药 药品说明书 特殊人群用药 

分 类 号：R95[医药卫生—药学]