随着中草药在全球范围的广泛应用及药品不良反应监测体系的不断完善，中药、天然药物及其相关制剂引起肝损伤的报道呈增加趋势，引起人们较大关注和重视。由于缺少特异性诊断指标，药物性肝损伤（drug-induced liver injury，DILI）的准确诊断仍然是国际性难题。而由于中草药具有组成和用法的复杂性特点，如中草药品种混淆、炮制不当、有害物质污染等质量相关因素，以及中西药配伍、未辨证用药、患者自身体质等影响因素的复杂性，造成中草药相关肝损伤（herb-induced liver injury，HILI）在临床上常出现难以准确诊断或者诊断不准确的情况。此外，限于对中草药安全用药知识的科普不足、公众对中草药不良反应的相关知识和认知水平的局限性，目前还存在一些对中草药毒副反应的错误认识以及误导性舆论，不利于提高中草药临床用药安全水平。为了规范和提高HILI诊断的准确性和客观性，促进中草药安全用药水平发展，最近中华中医药学会研究发布了国内外首个专门针对HILI的诊疗技术标准——《中草药相关肝损伤临床诊疗指南》。针对该指南内容，分析解读可能导致HILI误诊的影响因素，重点解读该指南所推荐采用的中草药肝损伤客观诊断证据链策略的技术适用性及优势，为中、西医医务人员和科研人员更好地使用该指南提供参考。

With the worldwide extensive application of Chinese herbal medicines and the continuous improvement of the adverse drug reaction (ADR) monitoring system, increasing attentions are focused on herb-induced liver injury (HILI) in recent years. Due to the lack of specific diagnostic indices, the diagnosis of drug-induced liver injury (DILI) is still a great challenge worldwide. Moreover, it is much difficult and often encounters the obstacles to get accurate diagnosis of HILI, since the complexities of constituents and clinical usage of herbal medicines, which includes the misuse of herb origin, improper processing, contamination of hazardous substances, improper drug combination, and improper usage without differentiating patients' syndrome, as well as diversity of patients' organism status. In addition, there are still limitations of knowledge on ADR or toxicity of herbal medicines in public population and sometimes misleading media opinions existance, causing unfavorable effects in development on safety usage of herbal medicines. In order to improve the objectivity and accuracy for diagnosis of HILI, the China Association of Chinese Medicines published the first clinical standard aiming at HILI management-"Guideline for Diagnosis and Treatment of Herb-Induced Liver Injury". In this paper, according to the HILI Guideline, the influencing factors to accurate HILI diagnosis have been discussed. And a brief interpretation has been illustrated to analyze the applicability and advantage of the integrated evidence chain-based causality identification strategy, recommended by the HILI Guideline, so as to provide the practical references for the medical staff and the researchers worked on either Chinese or Western medicine.

国家“重大新药创制”科技重大专项课题（2015ZX09501-004-001-008）；国家公益性行业专项课题（201507004-04）；北京市自然科学基金项目（7152142）