中国医院用药评价与分析2024，Vol.24Issue(7)：778-782,5.DOI:10.14009/j.issn.1672-2124.2024.07.003
日本汉方药物的妊娠期和哺乳期风险评估及对我国中成药的影响
Assessment of Risks of Japanese Kampo Medicine on Pregnancy and Lactation and Its Effects on Traditional Chinese Medicine
摘要
Abstract
OBJECTIVE:To evaluate risks of Japanese Kampo medicine and its effects on risk assessment of pregnancy of traditional Chinese medicine(TCM)in China by analyzing risks of Japanese Kampo medicine on pregnancy and lactation in drug instructions,so as to provide reference for further development of the risk assessment of pregnancy and lactation of TCM in China.METHODS:According to the Pharmaceuticals and Medical Devices Agency(PMDA)platform,148 kinds of Japanese Kampo medicine related drug instructions were collected and sorted out,the related statements during pregnancy and lactation were analyzed,and the Japanese Kampo medicine and TCM components with drug risks were evaluated.Additionally,potential risks of pregnancy and lactation of Japanese Kampo medicine were evaluated with Pharmacopoeia of the People's Republic of China(Volume 1,2020 edition),Pharmacovigilance of Traditional Chinese Medicine,Theory on the Nature of Traditional Chinese Medicine.Based on Japanese Kampo components during pregnancy,the risk assessment of 505 Chinese patent medicines during pregnancy was carried out to analyze the effects on the pregnancy risk of Chinese patent medicines.RESULTS:Of the 148 kinds of Japanese Kampo medicines,there were 39 with risks on pregnancy.The risk components of TCM in pregnancy included Radix rhei et rhizome,Cortex Moutan,Aconiti lateralis radix praeparata,Persicae semen,Achyranthis bidentatae radix,mirabilite and Carthami flos,mainly due to their own toxicity and effects on abortion and premature delivery.Among the lactation-risk Kampo medicines,there were 18 medicines that were prone to cause diarrhea in newborns due to the presence of Radix rhei et rhizome.According to the evaluation of Chinese classics,there were 93 kinds of potential risks of Japanese Kampo medicines.Based on Japanese Kampo risk components,a total of 59 kinds of 505 TCM had potential risks during pregnancy,accounting for 17.1%of the 345 unlabeled contraindicated drugs during pregnancy.CONCLUSIONS:Risks of Japanese Kampo medicine on pregnancy and lactation are evaluated based on TCM components.The methods of risk statements on special populations of Kampo medicine can provide a reference for development of TCM in China.关键词
日本汉方药物/中药/中成药/妊娠期和哺乳期/潜在风险Key words
Japanese Kampo medicine/Traditional Chinese medicine/Chinese patent medicine/Pregnancy and lactation/Potential risk分类
医药卫生引用本文复制引用
杜博冉,史湘君,张雪艳,贡磊磊,姚伟洁,王雅丽,阴赪宏,冯欣..日本汉方药物的妊娠期和哺乳期风险评估及对我国中成药的影响[J].中国医院用药评价与分析,2024,24(7):778-782,5.基金项目
国家自然科学基金青年项目(No.72204170) （No.72204170）
首都卫生发展专项(No.首发2024-2-2115) （No.首发2024-2-2115）
北京市属医院科研培育项目(No.PZ2021028) （No.PZ2021028）
北京市医院管理中心临床医学专项经费资助(No.ZYLX202119) （No.ZYLX202119）
中国药学会医院药学专业委员会医院药学科研专项资助项目(No.CPA-Z05-ZC-2022-002) （No.CPA-Z05-ZC-2022-002）
首都医科大学附属北京妇产医院北京妇幼保健院"优青人才"计划专项经费资助(No.YQRC201813) （No.YQRC201813）
中华医学会临床药学分会2023年度临床药学青年项目(No.Z-2021-46-2101-2023) （No.Z-2021-46-2101-2023）
