【摘要】 本文在梳理代谢相关脂肪性肝病（MAFLD）临床试验评价指标和中医药治疗相关研究现状的基础上，结合MAFLD疾病特点及中医药疗效特征，提出了一个多维、分层、可操作的中医临床疗效评价体系框架。该体系涵盖肝脏组织学、影像学、生化指标、代谢指标、人体测量学、中医证候、患者报告结局和安全性指标等8个维度，并根据研究定位和疾病阶段进行分层设计。本文进一步探讨了证候评价标准化、研究设计规范、质量控制等实施路径，以期为开展高质量中医药临床研究提供方法学支撑，推动中医药疗效评价从“单指标”向“多维复合指标”转变。更多还原

【Abstract】 Based on a review of clinical trial assessment indices for metabolic dysfunction-associated fatty liver disease(MAFLD) and the current status of traditional Chinese medicine(TCM) research, this article proposes a multi-dimensional, stratified, and operable clinical efficacy evaluation framework for TCM with reference to the features of MAFLD and the therapeutic effect of TCM. This system encompasses eight dimensions of liver histology, radiology, biochemical indicators, metabolic markers, anthropometry, TCM syndromes, patient-reported outcomes, and safety indicators, which are stratified according to research objectives and disease stages. This study further explores the implementation pathways for the standardization of syndrome evaluation, research design norms, and quality control, in order to provide methodological support for conducting high-quality TCM clinical research and promote the transition of TCM efficacy evaluation from “single indicators” to “multi-dimensional composite indicators”.更多还原