近十年中医药治疗功能性消化不良的随机对照试验证据图分析*
作者：滕伊琳1，吴雅意1，林久淳1，陈昌乐2
单位：1.上海中医药大学 上海 201203；2.上海中医药大学气功研究所 上海 201203
引用：引用：滕伊琳，吴雅意，林久淳，陈昌乐.近十年中医药治疗功能性消化不良的随机对照试验证据图分析[J].中医药导报,2025,31(9):178-186.
DOI：10.13862/j.cn43-1446/r.2025.09.030
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摘要：
目的：通过系统性检索与梳理中医药用于治疗功能性消化不良（FD）的临床随机对照试验（RCT）现状，并采用证据图的方式加以呈现，总结该领域的现状与不足。方法：检索万方数据知识服务平台（Wanfang Data）、中国知网（CNKI）、维普中文期刊服务平台（CSTJ）、中国生物医学文献数据库（CBM）、PubMed、Cochrane Library、Web of Science、Embase数据库中关于中医药治疗FD的文献，检索时间为2014年1月至2024年7月，并通过图文结合的方式分析和展示证据。结果：共纳入373项临床研究。纳入文献存在样本量偏小、干预时间偏短、中医疗效评价指标缺乏统一标准、总有效率评价标准不一、主次要结局指标区分不清、对经济指标和远期预后缺乏关注、证据质量普遍不高等问题。结论：为了提升临床研究水平，未来的研究应完善研究方案，开展多中心、大样本的临床研究，并确立功能性消化不良中医临床研究核心结局指标集（COS-TCM-FD），促进中医药在FD的临床实践及循证医学领域的共同进步与发展。
关键词：功能性消化不良；中医药；随机对照试验；证据图；质量评价
Abstract：Objective: To systematically retrieve and sort out the
current status of clinical randomized controlled trials (RCTs) on traditional
Chinese medicine (TCM) for functional dyspepsia (FD), present it in the form of
evidence mapping, and summarize the current status and shortcomings in this
field. Methods: Literatures on TCM treatment of FD were retrieved from Wanfang
Data Knowledge Service Platform (Wanfang Data), China National Knowledge
Infrastructure(CNKI), China Science and Technology Journal Database (CSTJ),
Chinese Biomedical Literature Database (CBM), PubMed, CochraneLibrary, Web of
Science, and Embase databases, with the retrieval time from January 2014 to
July 2024. Evidence was analyzed and presented in a combination of graphs and
text. Results: A total of 373 clinical studies were included. The included
literatures had problems such as small sample size, short intervention time,
lack of unified standards for TCM efficacy evaluation indicators, inconsistent
standards for total effective rate evaluation, unclear distinction between
primary and secondary outcome indicators, lack of attention to economic
indicators and long-term prognosis, and generally low evidence quality.
Conclusion: To improve the level of clinical research, future studies should
optimize research protocols, conduct multi-center and large-sample clinical
studies, and establish a core outcome set for TCM clinical research on
functional dyspepsia (COS-TCM-FD) to promote the joint progress and development
of TCM in clinical practice and evidence-based medicine.
Key words：functional dyspepsia; traditional Chinese medicine; randomized controlled trial; evidence mapping; quality evaluation
发布时间：2026-01-08
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