Abstract: The contradiction between the highly individualized nature of Traditional Chinese Medicine（TCM） treatment and the rigorous requirements of research design is one of the main reasons for the lack of high - quality research in the field of TCM. Therefore，an effective tool is needed to accurately investigate the impact of differences in research design or potential biases on research outcomes，thereby providing scientific guidance for the design of TCM research. Meta-epidemiological studies are an important tool for identifying and quantifying the impact of potential bias characteristics. They can reveal potential issues in the design of TCM clinical trials and quantitatively assess the influence of relevant factors on research outcomes. By evaluating the differences between TCM research designs or novel research designs and standardized research designs，reliable evidence-based evidence can be provided for the development direction of TCM clinical research design.

Key words: Meta-epidemiological study, Traditional Chinese medicine, Clinical research, Trial design, Research progress

摘要： 中医药治疗的高度个体化特征与严谨的研究设计之间的矛盾，是导致中医药领域缺乏高质量研究的主要原因之一，因此，需要一种有效工具来准确探究研究设计差异或潜在偏倚对研究效果的影响，从而为中医药研究设计提供科学指导。Meta流行病学研究是一种用于识别与量化潜在偏倚特征影响的重要工具，可以揭示中医药临床试验设计中的潜在问题，并定量评估相关因素对研究结果的影响。通过评估中医药研究设计或新型研究设计与标准化研究设计间的差异，可为中医药临床研究设计发展方向提供可靠的循证证据。

关键词: Meta 流行病学研究, 中医药, 临床研究, 试验设计, 研究进展