感冒类中成药说明书中妊娠及哺乳期妇女用药信息分析  

Analysis of Medication Information of Pregnant and Lactating Women in the Instructions of Chinese Patent Medicines for Common Cold

作　　者：杨亚蕾[1] 苗明三[2] 凌霄 屈红丽 李春晓[1] YANG Yalei;MIAO Mingsan;LING Xiao;QU Hongli;LI Chunxiao(The First Affiliated Hospitalto Henan University of Chinese Medicine,Zhengzhou Henan China 450000;Henan University of Chinese Medicine,Zhengzhou Henan China 450046;Zhoukou Hospital of Chinese Medicine,Zhoukou Henan China 466000)

机构地区：[1]河南中医药大学第一附属医院,河南郑州450000 [2]河南中医药大学,河南郑州450046 [3]周口市中医院,河南周口466000

出　　处：《中医学报》2021年第9期2005-2009,共5页Acta Chinese Medicine

基　　金：河南省科技攻关计划项目(202102310182);河南省中医药科学研究专项课题项目(2019JDZX202)。

摘　　要：目的:采用数据挖掘对感冒药类中成药说明书中妊娠及哺乳期使用信息标注的情况进行系统分析和探讨,为妊娠及哺乳期妇女合理有效应用中成药提供相关数据支持。方法:对常用普通感冒药类中成药说明书中妊娠和哺乳期使用信息标注情况进行调查和收集,并根据2020版《中华人民共和国药典》中含有妊娠禁用、慎用成分的感冒类中成药中用药信息进行收集,采用频数统计和百分比统计法对其结果进行分析。结果:共统计感冒药类中成药80个品种、113个药品说明书;其中处方药说明书41份,非处方药说明书72份。处方药说明书中有效信息标注率:妊娠期妇女占41.46%,哺乳期妇女占14.63%;非处方药说明书中有效信息标注率:妊娠期妇女占26.39%,哺乳期妇女占8.34%。80种感冒类中成药中含有妊娠慎用和禁用的中成药共计21种,说明书中标注妊娠期有效信息的有13种,标注哺乳期有效信息的只有3种。结论:中成药说明书中妊娠及哺乳期用药信息有效标注率较低,建议加强管理,需要进一步完善说明书中相关内容,为中成药的临床合理使用提供支持。Objective: To systematically analyzes and discusses the medication information of pregnant and lactating women in the instructions of Chinese patent medicines for common cold based on data mining to provide relevant data support for the rational and effective application of Chinese patent medicines by pregnant and lactating women.Methods: The use information of pregnancy and lactation in the instructions of Chinese patent medicines for common cold was investigated and collected.According to the 2020 edition of Pharmacopoeia of the People′s Republic of China, information on the use of Chinese patent medicines for common cold that contain ingredients that are prohibited and used with caution during pregnancy were collected.The results were analyzed by frequency statistics and percentage statistics.Results: A total of 80 varieties and 113 drug instructions of Chinese patent medicines for common cold were counted;there were 41 prescription drug instructions and 72 over the counter drug instructions.The labeling rate of effective information in prescription drug instructions: pregnant women accounted for 41.46% and lactating women accounted for 14.63%;the labeling rate of effective information in over the counter drug instructions: pregnant women accounted for 26.39% and lactating women accounted for 8.34%.Among the 80 kinds of Chinese patent medicines for common cold, there were 21 kinds of Chinese patent medicines that were used with caution and forbidden during pregnancy, there were 13 kinds of valid information during pregnancy and there were only 3 kinds of valid information about lactation.Conclusion: The effective labeling rate of medication information during pregnancy and lactation in the instructions of Chinese patent medicine is low.It is suggested to strengthen management and further improve the relevant contents in the manual to provide support for the clinical rational use of Chinese patent medicine.

关 键 词：感冒 中成药 妊娠期 哺乳期 用药信息 中成药说明书 

分 类 号：R288[医药卫生—中药学]