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近年来中药不良反应特别是传统无毒中药的肝损伤问题屡有报道,引起人们对中药安全性的严重担忧,与此同时传统无毒中药肝损伤的客观性在业内外也存在巨大争议。如何科学认知传统无毒中药的肝损伤已成为本领域最具挑战性的国际性难题。既往研究多拘泥于从药物角度寻找毒性物质及致毒机制,对可能由患者机体因素,特别是机体免疫介导的中药特异质型肝损伤鲜有关注和研究。笔者对中药肝损伤客观辨识与评价中存在的问题进行分析,阐述机体免疫与药物特异质型肝损伤的关系,同时以传统无毒中药何首乌为例,分析其诱导的免疫特异质肝损伤的客观真实性及其机制,在此基础上笔者课题组首次提出了中药特异质肝损伤免疫应激“三因致毒”机制假说,为传统无毒中药肝毒性的客观辨识和评价提供了理论依据,创新和发展了中药安全性评价模式和方法,对于揭示中药肝毒性的客观性具有重要的价值。
In recent years, the adverse reactions of traditional Chinese medicine, especially the traditional non-toxic traditional Chinese medicine liver injury have been repeatedly reported, causing people’s serious concerns about the safety of traditional Chinese medicine, while the objectivity of traditional non-toxic traditional Chinese medicine liver injury in the industry there is also a huge controversy. How to scientifically understand the traditional non-toxic liver injury has become the most challenging international problem in the field. Previous studies focused more on the search for toxic substances from the drug point of view and the mechanism of toxicosis, and may focus on patients with body factors, especially the immune-mediated traditional Chinese medicine-specific liver injury rarely attention and research. The author analyzes the problems existing in the objective identification and evaluation of traditional Chinese medicine liver damage, and expounds the relationship between the immunity of the body and drug-specific liver injury. At the same time, taking traditional Chinese medicine Polygonum multiflorum as an example, the author analyzes the induced immune-specific liver injury Based on the objective authenticity and mechanism, based on the author’s task force for the first time put forward the TCM-specific liver injury immune stress “three poisoning” mechanism hypothesis for the traditional non-toxic traditional Chinese medicine, objective identification and evaluation of hepatotoxicity Provided a theoretical basis, innovated and developed the evaluation model and method of Chinese medicine safety, which is of great value for revealing the objectivity of Chinese medicine hepatotoxicity.