中国全科医学

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Meta流行病学研究在中医药临床研究设计中的应用与思考

张艺尹1,2,张彭1,2,赵滟菲1,2,谢洋1,3,4*,陈涛3,5*   

  1. 1.河南中医药大学第一附属医院国家区域中医(肺病)诊疗中心; 2.河南中医药大学第一临床医学院; 3.河南中医药大学,呼吸疾病中医药防治省部共建协同创新中心/河南省中医药防治呼吸病重点实验室; 4.河南中医药大学第一附属医院,河南省呼吸疾病循证评价国际联合实验室; 5.L3 5QA, Global Health Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK
  • 收稿日期:2025-04-15 修回日期:2025-06-17 接受日期:2025-07-09
  • 通讯作者: 谢洋,主任医师;陈涛,研究员
  • 基金资助:
    国家重点研发技术“中医药现代化”重点专项(2023YFC3502601); 河南中医药大学“双一流”创建工程(HSRP-DFCTCM-2023-4-05); 中原科技创新领军人才计划(254000510041); 河南省中医药科学研究专项课题(2024ZYZD04,2023ZY2055); 国家科技重大专项(2023YFC3502600)

Considerations and Applications of Meta-epidemiological Research in the Design of Clinical Studies of Traditional Chinese Medicine

  • Received:2025-04-15 Revised:2025-06-17 Accepted:2025-07-09
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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

Abstract: The contradiction between the highly individualized nature of traditional Chinese medicine (TCM) treatment and the rigors of research design represents one of the primary factors contributing to the scarcity of high-quality research within the realm of TCM. Thus, there is a pressing need for an effective instrument to precisely investigate the influence of research design variations or latent biases on research outcomes, thereby offering scientific guidance for TCM research design. Meta-epidemiological research is an important tool for identifying and quantifying the impact of potential bias characteristics. It can uncover potential issues in the design of TCM clinical trials and quantitatively evaluate the effects of relevant factors on research findings. By assessing the disparities between TCM research designs or novel research designs and standardized research designs, it is possible to provide reliable evidence-based insights into the developmental direction of TCM clinical research design.