摘要
目的了解妇产科用中成药说明书中关于妊娠和哺乳期妇女用药标注情况,为妊娠及哺乳期妇女合理用药提供建议。方法收集江西省妇幼保健院2021年妇产科常用中成药说明书共148份,与2020年版《中国药典》及2015年版《临床用药须知》进行比对,分析其差异,探讨中成药说明书妊娠及哺乳期禁忌标注存在的问题。结果148种中成药,说明书标注妊娠禁忌83种(56.08%);《临床用药须知》收录率为63.51%、妊娠禁忌标注率为40.54%,均显著高于《中国药典》(37.84%、14.86%);三者妊娠禁忌标注一致仅10种;药品说明书标注哺乳期禁忌7种,《中国药典》收录且标注哺乳期禁忌有3种,《临床用药须知》收录且标注哺乳期禁忌有4种,标注情况均较低。其中62种含妊娠禁用、慎用成分中成药,说明书标注与所含成分相符的有11种,标注为“尚不明确”的有13种;34种不含妊娠禁用、慎用等成分,标注为妊娠禁忌。结论中成药说明书妊娠和哺乳期禁忌标注存在标注缺失和不明确现象,且内容较为分散;说明书与《中国药典》《临床用药须知》标注不统一。建议加强妊娠及哺乳期用药登记研究,制定中成药说明书中“孕妇及哺乳期妇女用药”项目的撰写指导原则,及时更新、完善并规范药品说明书,使《中国药典》《临床用药须知》等专业参考书尽可能地协调与统一,增强对用药人群的指导性,促进中成药合理用药。
Objective To understand the labeling situation of pregnant and lactating women in the instructions of Chinese patent drug used in obstetrics and gynecology,and provide suggestions for rational use of drugs for pregnant and lactating women.Methods A total of 148 instructions for traditional Chinese patent drug from the pharmacy of Jiangxi Maternal and Child Health Hospital in 2021 were collected.Compared them with the 2020 edition of"Chinese Pharmacopoeia"and the 2015 edition of"Clinical Medication Instructions",the differences were analyzed.And explored the existence of contraindications for pregnancy and lactation in the instructions of Chinese patent drug question.Results Among 148 kinds of Chinese patent drug,83 kinds of pregnancy contraindications were marked in the instructions;the inclusion rate of"Clinical Medication Instructions"was 63.51%,and the rate of contraindications in pregnancy was 40.54%,which were significantly higher than that of"Chinese Pharmacopoeia(37.84%、14.86%)".There were only 10 kinds of drugs had the same labeling pf pregnancy contraindications as the"Clinical Medication Instructions"and the"Chinese Pharmacopoeia".There are 7 kinds of contraindications for breastfeeding marked in the drug instructions,3 kinds of contraindications for lactation included in the"Chinese Pharmacopoeia",and 4 kinds of contraindications for lactation included in the"Clinical Medication Instructions",all of which were relatively low.Among them,62 kinds of Chinese patent drug contain ingredients that were contraindicated in pregnancy and should be used with caution,11 of which were marked in the instructions consistent with the ingredients contained in them,and 13 kinds were marked as"unclear";34 kinds do not contain ingredients that were prohibited in pregnancy and used with caution,and were marked contraindicated in pregnancy.Conclusion There are missing and unclear labels on contraindications for pregnancy and lactation in the instructions of Chinese patent medicines,and the content is relatively scattered.The labels in the instructions are not consistent with"Chinese Pharmacopoeia"and"Clinical Medication Instructions".It is recommended to strengthen the research on drug registration during pregnancy and lactation,formulate guidelines for writing the item"drug for pregnant women and lactating women"in the instructions of Chinese patent drug,update,improve and standardize drug instructions in a timely manner,and make"Chinese Pharmacopoeia"and"Clinical Medication Instructions"etc.Professional reference books should be coordinated and unified as much as possible to enhance the guidance for drug users and promote the rational use of Chinese patent drug.
作者
艾美玲
徐超
龙耀
俞燕
高雨蒙
李雷旻
AI Meiling;XU Chao;LONG Yao;YU Yan;GAO Yumeng;LI Leimin(Jiangxi Maternal and Child Health Hospital,Nanchang Jiangxi 330006,China;The Second Affiliated Hospital of Nanchang University,Nanchang Jiangxi 330006,China.)
出处
《药品评价》
CAS
2023年第5期525-530,共6页
Drug Evaluation
关键词
说明书
中成药
妊娠
哺乳期
合理用药
药物配伍禁忌
Instructions
Chinese patent drug
Pregnancy
Lactation
Reasonable medication
Drug incompatibility
作者简介
艾美玲,硕士,主管药师。研究方向:临床药学。E-mail:aimeiling0911@163.com;通信作者:李雷旻,本科,副主任药师。研究方向:中药学。E-mail:1346642426@qq.com。
