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

目的:通过对日本汉方药物的药品说明书进行妊娠期和哺乳期风险分析,评估日本汉方药物的用药风险及其对于我国中成药妊娠期风险评估的影响,为进一步开展我国中成药的妊娠期和哺乳期风险评估提供借鉴及参考。方法:针对日本医药品与医疗器械局平台收集及整理的148种医用日本汉方药物相关药品说明书,分析妊娠期和哺乳期相关表述,评估具有用药风险的日本汉方药物及中药组分。结合我国《中华人民共和国药典:一部》(2020年版)、《中药药物警戒》和《中药药性论》等中药典籍,对日本汉方药物可能存在的妊娠期潜在风险进行评估。基于日本汉方药物妊娠期风险中药组分,对我国505种中成药进行妊娠期风险评估,分析其对我国中成药妊娠期风险的影响。结果:日本148种日本汉方药物中,存在妊娠风险的药物共39种。妊娠期风险的中药组分包括大黄、牡丹皮、附子、桃仁、牛膝、芒硝和红花,主要为自身毒性及对于流产、早产的影响。哺乳期风险日本汉方药物中,因含有大黄而易引起新生儿腹泻的药物共18种。根据我国典籍评估,日本汉方药物具有潜在风险共93种。依据日本汉方药物风险组分,我国505种中成药中具有妊娠期潜在风险的药物共59种,占345种未标注妊娠期禁忌药物种类的17.1%。结论:日本汉方药物基于妊娠期和哺乳期风险的中药组分对其日本汉方药物成药风险进行评估,其特殊人群的风险表述方法对我国中成药发展具有一定的借鉴意义。

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 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.