基于间接毒性认知的中药安全风险防控

doi:10.19803/j.1672-8629.2021.11.02

摘要/Abstract

摘要： 长期以来中药安全性认知和研究主要拘泥于药物本身的固有毒性,然而针对近年来相继报道的传统无毒中药安全性事件,仅依靠固有毒性/直接毒性的评价往往难以做出科学的解释并制定有效的防控措施。本文结合现有中药毒性认知理论及研究成果,进一步提出基于间接毒性认知的中药安全性风险防控策略,重点阐释了间接毒性与固有毒性或免疫原性的区别,提出其发生多与机体状态、原患疾病等因素密切相关,并基于间接毒性认知,探讨如何科学评价和防控中药安全风险,以期为指导临床安全合理用药、促进中医药事业健康发展提供新思维和新对策。

关键词: 间接毒性, 中药, 安全性评价, 风险防控

Abstract: For a long time, our knowledge of and research on the safety of traditional Chinese medicine(TCM) have been confined to the inherent toxicity of drugs. However, safety incidents of non-toxic traditional Chinese medicine have been frequently reported in recent years. It is often difficult to make scientific explanations and formulate effective prevention and control measures by evaluating inherent toxicity or direct toxicity alone. Based on the current knowledge and research findings of indirect toxicity of TCM, we recommended strategies for prevention and control of safety risks. We focused on explanation of the difference between indirect toxicity and intrinsic toxicity or immunogenicity. We also discussed how to evaluate and prevent safety risks of TCM effectively in order to provide new ideas and countermeasures for guiding clinical safety and rational use of medicines and promoting the healthy development of traditional Chinese medicine.

Key words: indirect hepatotoxicity, traditional Chinese medicine, safety evaluation, risk prevention and control

中图分类号:

R994.1

高云娟, 赵旭, 柏兆方, 王伽伯, 湛小燕, 郭玉明, 肖小河. 基于间接毒性认知的中药安全风险防控[J]. 中国药物警戒, 2021, 18(11): 1004-1008.

GAO Yunjuan, ZHAO Xu, BAI Zhaofang, WANG Jiabo, ZHAN Xiaoyan, GUO Yuming, XIAO Xiaohe. Prevention and Control of Safety Risks of Traditional Chinese Medicine Based on Indirect Knowledge of Toxicity[J]. Chinese Journal of Pharmacovigilance, 2021, 18(11): 1004-1008.

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