随着中草药的广泛应用，有关中草药相关肝损伤（herb-induced liver injury，HILI）的病例报道显著增加，然而中药及其代谢产物成分繁杂，其所诱导肝损伤的物质基础及机制也较为复杂，导致HILI的诊断存在一定困难。目前临床诊断HILI主要依据Roussel Uclaf因果关系评价法、整合证据链法、结构化专家观点程序法及中医诊断等方法，各有其优缺点；早期诊断对于HILI的防治具有重要意义，而特异性生物标志物的筛选是最有潜力的方向，目前处于研发阶段。为此，在论述HILI的常见发病机制的基础上，对HILI的临床诊断方法的现状及早期诊断生物标志物的研究进展进行综述，为HILI的诊疗及相关研究提供参考。

With the widespread application of Chinese herbal medicines, the reported cases of herb-induced liver injury (HILI) have increased significantly. Ascribing to the componential complexity of traditional Chinese medicines (TCM) and their metabolites, the material basis and mechanisms of HILI are complex, which results in certain difficulties in the diagnosis of HILI. Currently, the clinical diagnosis of HILI is mainly based on the Roussel Uclaf causality evaluation method, integrated evidence chain method, structured expert opinion procedure method, and TCM diagnosis methods, and these diagnosis methods have their advantages and disadvantages. Moreover, early diagnosis is of great significance for the prevention and treatment of HILI, and screening specific biomarkers is the most potential direction, which is currently in the research and development stage. Therefore, this paper review summarizes the common pathogenesis mechanisms of HILI, the current clinical diagnosis methods involved in HILI, and the research advance of biomarkers for the early diagnosis of HILI, which is expected to provide a cure for the diagnosis and treatment of HILI and related research.

国家自然科学基金资助项目（82174067）；国家自然科学基金资助项目（81960646）；兰州大学本科生科研创新项目（20230060005，20220060116）