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中成药治疗心力衰竭随机对照试验近十年证据图分析OA

Evidence Mapping Analysis of Randomized Controlled Trials on Chinese Patent Medicines for Heart Failure Over the Past Decade

中文摘要英文摘要

目的 运用证据图的方法,系统检索并梳理中成药治疗心力衰竭随机对照试验(RCTs),展示该领域证据分布.方法 通过检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献数据库(SinoMed)、PubMed、Embase、Cochrane Library、Web of Science 数据库,检索时间范围为2016年1月1日-2025年10月1日.提取文献的发表年份、样本量、干预时间、结局指标等核心信息,采用文字与气泡图等图表相结合的方式进行描述性统计分析.结果 本研究共纳入781篇RCTs.结果 显示:近十年相关发文量呈波动下降趋势;研究共涉及48种中成药,多数研究为干预2~4周的50~100例小样本试验;仅85篇研究明确了中医证型;结局指标异质性大,缺乏对远期硬终点的关注;且纳入研究的方法学设计与报告质量整体偏低.结论 现有研究在样本规模、干预时长、辨证论治体现及远期硬终点评估方面存在明显局限,整体证据质量有待提升.

Objective To systematically retrieve and synthesize randomized controlled trials(RCTs)on Chinese patent medicines for the treatment of heart failure using an evidence mapping approach,and to present the evidence distribution in this field.Methods Eight databases,including CNKI,Wanfang,VIP,SinoMed,PubMed,Embase,Cochrane Library,and Web of Science,were searched for literature published from January 1,s2016,to October 1,2025.Core information such as publication year,sample size,intervention duration,and outcome measures were extracted.Descriptive statistical analysis was conducted using a combination of textual descriptions and visual charts,including bubble charts.Results A total of 781 RCTs were included.The findings revealed a fluctuating downward trend in the volume of relevant publications over the past decade.The studies involved 48 Chinese patent medicines and were predominantly small-sample trials(50-100 cases)with short intervention durations(2-4 weeks).Only 85 studies specified Chinese medicine(CM)syndrome types.Furthermore,the outcome measures exhibited high heterogeneity with a lack of attention to long-term hard outcomes,and the overall methodological design and reporting quality of the included studies were relatively low.Conclusion Current studies demonstrate significant limitations regarding sample size,intervention duration,the integration of CM syndrome differentiation,and the evaluation of long-term hard outcomes,indicating that the overall evidence quality requires improvement.

任高灿;张晋珲;马晓昌

中国中医科学院西苑医院心血管科,国家中医心血管病临床医学研究中心(北京 100091)中国中医科学院西苑医院心血管科,国家中医心血管病临床医学研究中心(北京 100091)中国中医科学院西苑医院心血管科,国家中医心血管病临床医学研究中心(北京 100091)||中医证候全国重点实验室(北京 100091)

中成药心力衰竭随机对照试验证据图方法学质量

Chinese patent medicineheart failurerandomized controlled trialsevidence mapmethodological quality

《中国中西医结合杂志》 2026 (5)

541-546,6

国家自然科学基金面上项目(No.82374280)

10.7661/j.cjim.20260401.040

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