中医药治疗慢性乙型肝炎在我国应用广泛，但是由于缺少高质量的临床试验，现有系统评价难以形成中医药治疗乙肝的确切疗效。中医临床研究的结局指标科学性不强、实用性较差、标准差异大且其测量方法和测量时间点不统一是造成这一问题的主要原因之一。为了解决这一问题，本研究以慢性乙型肝炎为切入点，提出建立中医临床研究核心结局指标集，采用近年来国际上逐渐兴起的核心结局指标集的研究方法，通过既往临床试验的系统回顾建立结局指标集合，并通过临床专家、方法学专家、政策制定者与管理者、中医药编辑与医药企业等多方专家共识，建立慢性乙型肝炎中医临床研究核心结局指标集结构域与核心指标，并确定其定义、测量工具/方法、时间、临床意义、可操作性及可接受性，并将其与国内外慢性乙型肝炎指南进行对比，并加以完善。核心结局指标集的建立将有助于规范中医临床研究的设计与报告，从而为临床决策提供高质量的循证证据和明确的结论。

Chinese medicine has been widely applied in chronic hepatitis B in our country, but because of lacking of high quality clinical trials, the existing evaluation system is difficult to form the exact conclusion of curative effect of TCM treatment for hepatitis B. The outcomes of the clinical research of TCM indicators scientific is not strong, poor practicability, large difference of standard and its measuring method and measuring point in time not unified is one of the main reasons for this problem. In order to solve this problem, chronic hepatitis B as the breakthrough point, this study proposes the establishment of traditional Chinese medicine clinical research core outcomes set, adopt methods of core outcomes set that emerging in recent years, by reviewing the system of previous clinical trials to establish the outcomes collection and clinical experts, and through the methodology experts, policy makers and managers, editor of Chinese medicine and pharmaceutical companies such as many expert consensus, establish a clinical research of TCM of chronic hepatitis B core outcomes set structure domain and the core outcomes, and to determine its definition, measurement tools/methods, time, clinical significance, feasibility and acceptability, and compare it with chronic hepatitis B guidelines, and be perfected. The establishment of the core outcomes set will help to design and report of clinical research of TCM, thus provides the high quality for the clinical decision of evidence-based evidence and a clear conclusion.