妊娠期中药应用安全性评价的思路与策略

Strategies for the Safety Evaluation of Traditional Chinese Medicine in Pregnancy

中药在妊娠期女性中应用广泛,其应用安全风险大多未知,这给临床决策带来很多困扰。我国尚未根据中医药的特色建立妊娠期中药应用安全性评价体系,随着中医药的不断发展,对妊娠期使用中药的风险进行评估的方法学问题日渐凸显。该文概述妊娠期使用中药的现状,对中药的临床前研究与临床研究进行分析,结合国外妊娠暴露登记研究的策略,探讨妊娠期中药应用安全性评价的思路,以期为孕妇提供风险评估与用药指导,为中药妊娠期安全性评价体系的建立奠定基础。

Traditional Chinese Medicine(TCM)is widely used in pregnant women,while the adverse reaction and safety risks of TCM are mostly unknown,which brings many troubles to clinical decision-making.China has not yet established a safety evaluation system for the application of TCM during pregnancy according to the characteristics of TCM.With the continuous development of TCM,the methodological problem of assessing the risks of using TCM in pregnancy has become increasingly prominent.This paper summarizes the current situation of the use of TCM in pregnancy,and analyzes the methods and progress of TCM preclinical and clinical research.Combining with the foreign pregnancy exposure registration strategy,we discuss the idea of TCM safety evaluation in pregnancy,to provide risk assessment and medication guidance,and lay a foundation for establishing of the safety evaluation system of TCM in pregnancy.