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.

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. [ABSTRACT FROM AUTHOR]