摘要
当今人类疾病谱、体质谱和用药行为等发生了深刻变化,中药安全性领域出现了新形势和新问题,特别是传统无毒中药频频曝出肝损伤、肾损害等严重不良反应/事件,颠覆了人们对中药安全性的传统认识,甚至动摇了国内外公众对发展中医药的信心。那么,在新时代全球化的形势下,如何正确认识我国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?这是新时代下中医药科技工作者必须认真思考和回答的问题。该文提出应客观辩证看待中药安全性形势和问题,与时俱进地提高中药安全用药水平,首次提出并阐述了中药新安全观的思想及方法体系,即一个创新认识、两类评价模式、三因致毒理论、四象风险决策、五级安全证据体,希冀为破解中药安全性难题提供新理论、新策略、新方法及成功范例。
Today,profound changes have taken place in human diseases spectrum,constitution spectrum and drug use behavior,which emerged new situations and problems in the field of traditional Chinese medicine(TCM)safety.In particular,serious adverse reactions/events such as liver injury and kidney injury have been frequently reported in traditional non-toxic TCM,overturning people's understanding of TCM safety,and even shaking the public's confidence in the development of TCM.Therefore,the new era of globalization,how to correctly understand the situation and problems of TCM safety?How to solve the safety evaluation and risk prevention dilemma of TCM?Those are questions that TCM practitioners must think about and answer seriously in the new era.This paper proposes that the situation and problems of TCM safety should be viewed objectively and dialectical,and the TCM safe use standard should advance with the times.The conception and methodology of the new outlook on TCM safety is put forward and expounded for the first time(Abbreviated as:One innovative understanding;Two kinds of evaluation modes;Tri-elements injury hypothesis;Four-quadrant risk decision processes;Five-level safety evidence body),hoping to provide new theories,new strategies,new methods and successful examples for solving the safety problems of TCM.
作者
肖小河
赵旭
柏兆方
王伽伯
宋海波
XIAO Xiao-he;ZHAO Xu;BAI Zhao-fang;WANG Jia-bo;SONG Hai-bo(Department of Hepatology,The Fifth Medical Centre of Chinese PLA General Hospital,Beijing 100039,China;School of Traditional Chinese Medicine,Capital Medical University,Beijing 100069,China;Center for Drug Reevaluation National Center for ADR Monitoring,Beijing 100045,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2023年第10期2557-2564,共8页
China Journal of Chinese Materia Medica
基金
国家自然科学基金项目(81721002,82230118)
国家中医药管理局中医药传承与创新(岐黄学者)项目([2018]288)
国家中医药管理局中医药创新团队及人才支持计划项目(ZYYCXTD-C-202005)
北京市杰出青年科学基金项目(JQ21026)。
关键词
中药
安全性评价
风险防控
新安全观
肝毒性
TCM
safety evaluation
risk prevention
new outlook on TCM safety
hepatotoxicity
作者简介
通信作者:肖小河,研究员,主要从事临床中药学与安全用药研究,E-mail:pharmacy302@126.com。
