中文摘要：

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。

英文摘要：

In recent years, the report of adverse reaction of traditional Chinese medicine （TCM） , especially the traditional non-toxic TCM-indnced liver injury problems have been repeatedly arising, causing serious concerns about the safety of TCM from the public, and meanwhile there is a huge controversy about the objectivity of traditional non-toxic TCM-induced liver injury as well. How to scientifically acknowledge the side effects of traditional non-toxic TCM has become one of the most challenging and difficult international problems in this field. Previous studies may only focus on the search for toxic substances and toxic mechanisms from the perspective of drugs, so there is little attention and research on the factors that it may be caused by patients＇ bodies, especially the immune-mediated idiosyncratic drug induced liver injury. This paper carries on the analysis to the TCM-in- duced liver injury from the angles of objective identification and evaluation problems, elaborates the relationship between the immune and drug-induced liver injury, taking the traditional non-toxic TCM Polygonum Muhiflorum as an example to analyze the objective authenticity and mechanism of immune-mediated idiosyncratic drug induced liver injury, on which basis the immunological stress ＂Three Factors Causing toxicity＂ mechanism hypothesis of idiosyncratic TCM-induced liver injury has been frist put for- ward. This hypothesis also provides a theoretical basis for the objective identification and evaluation of traditional non-toxic TCM- induced liver injury, innovate and develop a new evaluation model and method of TCM＇s safety, which has a significant value for revealing the objectivity of TCM-induced liver injury.