273种中成药药品说明书妊娠禁忌标注情况调查分析  

Investigation and Analysis of Pregnancy Contraindication in Package Inserts of 273 Kinds of Chinese Patent Medicine

作　　者：付中华[1] 王丽[1] 马培志[1] FU Zhonghua;WANG Li;MA Peizhi(Henan Provincial People′s Hospital,Henan Zhengzhou 450003,China)

机构地区：[1]河南省人民医院,河南郑州450003

出　　处：《中国医药导刊》2021年第5期354-359,共6页Chinese Journal of Medicinal Guide

基　　金：中国药学会科技开发中心科普项目(项目编号:CMEI2021KPYJ00806;项目名称:科技传播在药学服务中的应用创新研究)。

摘　　要：目的:了解中成药妊娠禁忌标注的具体情况,为临床用药提供参考。方法:收集我院2020年1~6月在用中成药的药品说明书,参考2020年版《中华人民共和国药典》(以下简称《中国药典》)(一部)中妊娠禁忌药材和饮片,依据《中国药典》及《临床用药须知》中“注意”项,对比分析中成药在妊娠禁忌标注存在的不一致问题。结果:273种中成药被《中国药典》《临床用药须知》收录的分别是96、106种,收录率比较低。中成药成分与药品说明书、《中国药典》、《临床用药须知》妊娠禁忌标注项中完全一致的仅有8种,标注一致性较差。结论:中成药说明书妊娠禁忌标注缺省严重,临床妊娠用药需要结合患者情况参考多方数据,给予个体化建议。Objective:To analysis the instruction of pregnancy contraindication of Chinese patent medicine(CPM),and provide reference for rational drug use.Methods:Package inserts of CPM used in our hospital during January to June 2020 were collected.Referring to the pregnancy contraindicated materials and decoction pieces in Chinese Pharmacopoeia(part 1,2020 edition),and based on“note”item in Chinese Pharmacopoeia and Chinese Pharmacopeia Guidelines for Clinical Drug Use,problems existing in pregnancy contraindication instruction in package inserts of CPM were compared and analyzed.Results:For 273 kinds of CPM used in our hospital,96 were included in Chinese Pharmacopoeia and 106 were included in Chinese Pharmacopeia Guidelines for Clinical Drug Use.The rate of inclusion was relatively low.Only 8 kinds of CPM′s ingredients were in complete accordance with the instructions of pregnancy contraindication in package inserts,Chinese Pharmacopoeia and Chinese Pharmacopeia Guidelines for Clinical Drug Use,showing poor concordance.Conclusion:The pregnancy contraindication instructions are seriously missing in package inserts of CPM,and the patient's situation needs to be taken into consider in clinical medication during pregnancy based on the various datas to give individualized suggestions.

关 键 词：中成药 说明书 妊娠禁忌 中国药典 临床用药须知 

分 类 号：R95[医药卫生—药学]