中药安全性评价:新时代,新策略

Safety evaluation of traditional Chinese medicine:new era,new strategy

当今,随着中药在全球范围内使用越来越广泛,中药安全性领域出现了诸多新问题和新挑战,特别是传统“无毒”中药频频曝出肝损伤、肾损害等安全性问题/事件,颠覆了人们对中药毒性与安全性的传统认知,也给中医药健康及国际化带来了巨大挑战。那么如何客观认识中药安全性的形势及问题?如何科学破解中药安全性评价与风险防控难题?,本团队提出:一是要与时俱进,辨证看待中药安全性问题和形势,不要夸大,也不要小视;二是要突破“唯药物论毒性”的传统认知,创新中药毒性理论与安全性评价模式;三是要针对不同毒性类型中药,建立安全风险精准防控对策,推动中药安全风险管理从被动应对向科学主动防控转变。在此基础上,提出了“中药新安全观”思想及方法体系,希冀为系统性地破解中药安全性评价与风险防控难题提供新理论、新策略、新方法及成功范例。

Today,as the use of traditional Chinese medicine(TCM)becomes widespread globally,TCM is confronted with numerous new safety issues and challenges.In particular,the frequent emergence of safety issues/events such as liver and kidney injury associated with traditionally“non-toxic”TCM has overturned the conventional understanding of the toxicity and safety of TCM.This has also posed significant challenges to the development and internationalization of TCM.So,how should we understand the situation and problems of TCM safety?How can we scientifically solve the problems in evaluation and risk control of TCM?Our team proposes the following:First,we must keep pace with the times and view the issues of TCM safety in a dialectical manner,without exaggeration or underestimation.Second,we must break through the traditional perception that toxicity only came from the medicine itself,and innovate the theories of TCM toxicity.Third,we must establish precise prevention and control strategies for TCM with different types of toxicity,promoting a shift in the management of TCM safety risks from passive response to scientific and proactive control.On this basis,we have put forward the concept and methodological system of the“New Outlook on TCM safety”,hoping to provide new theories,strategies,methods,and successful examples for systematically solving the problems in the evaluation and risk control of TCM.