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中国临床药理学与治疗学 ›› 2025, Vol. 30 ›› Issue (2): 222-231.doi: 10.12092/j.issn.1009-2501.2025.02.009

• 定量药理学 • 上一篇    下一篇

注射用益气复脉治疗心力衰竭的证据图谱研究

吕仕超1,2,王云姣1,左一鸣1,商洪才2   

  1. 1天津中医药大学第一附属医院(国家中医针灸临床医学研究中心),天津300381;2北京中医药大学东直门医院,中医内科学教育部和北京市重点实验室,北京100700
  • 收稿日期:2024-04-10 修回日期:2024-05-29 出版日期:2025-02-26 发布日期:2025-02-05
  • 通讯作者: 商洪才,男,博士/博士后,研究员、教授,研究方向:中医药防治心血管疾病研究。 E-mail: shanghongcai@126.com
  • 作者简介:吕仕超,男,博士/博士后,主任医师、副教授,研究方向:中医药防治心血管疾病研究。 E-mail: dr_lv@foxmail.com
  • 基金资助:
    中国博士后科学基金面上项目(2022M710473);天津市中医药重点领域科研课题(2024002);天津市教委科研计划项目(2023ZD029);苏州工业园区东方华夏心血管健康研究院——力·心中药科研创新基金(2022-CCA-TCM-020)

Evidence map on the treatment of heart failure with Yiqifumai injection

LYU Shichao1,2, WANG Yunjiao1, ZUO Yiming1, SHANG Hongcai2   

  1. 1 First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China; 2 Chinese Academy of Medical Sciences and Peking Union Medical Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
  • Received:2024-04-10 Revised:2024-05-29 Online:2025-02-26 Published:2025-02-05

摘要:

目的:展现注射用益气复脉治疗心力衰竭领域证据分布情况。方法:检索CBM、CNKI、万方、VIP、Cochrane Library、PubMed、Embase及Web of Science等相关数据库,并查询中国临床试验注册中心、ClinicalTrials.gov,收集注射用益气复脉治疗心力衰竭疾病相关的临床研究、系统评价和指南共识,通过证据图谱研究方法采用表格展示文献占比、样本量、合并病症及系统评价的质量评价等数据,饼状图展示研究类型比例分布,折线图描述发表趋势,气泡图展现证据分布情况。结果:注射用益气复脉治疗心力衰竭发文量整体处于稳步发展阶段,目前的临床研究以小样本、单中心、短时程的随机对照试验(RCT)为主要研究对象,样本量多为60~100人,干预时长大多为14 d,基础疾病以冠心病为主。临床研究证据倾向于支持注射用益气复脉联合常规西药治疗心力衰竭在改善患者心功能和生活质量方面发挥疗效,但也存在研究整体质量较低,临床试验设计不合理、样本量较小、结局指标选择不完善、某些结局指标国际认可度较低、缺乏对长期结局的报告、随机对照试验和系统评价的方法学整体质量偏低等问题。结论:未来应开展更多大样本、多中心临床随机对照试验研究,获得更高级别的循证医学证据,充分展示中医治疗优势,推动中医心病学和循证医学的共同发展。

关键词: 注射用益气复脉, 心力衰竭, 证据图谱, 临床研究

Abstract:

AIM: To display the distribution of evidence in the field of Yiqifumai injection treatment for heart failure. METHODS: To retrieve relevant databases such as CBM, CNKI, Wanfang, VIP, Cochrane Library, PubMed, Embase, and Web of Science, and search for the China Clinical Trial Registry, ClinicalTrials.gov and collect clinical studies, systematic evaluations, and guideline studies on the treatment of heart failure with Yiqifumai injection. The evidence map research method use a table to display the proportion of literature, sample size, comorbidities, and quality evaluations of systematic evaluations. Use a pie chart to display the proportion distribution of research types, a line chart to describe publication trends, and a bubble chart to display the distribution of evidence. RESULTS: The overall number of articles on the treatment of heart failure with Yiqifumai injection is in a steady development stage. Clinical studies are mainly small sample, single center, short-term randomized controlled trials, with a sample size of 60-100 cases and an intervention duration of mostly 14 days. The underlying disease is mainly coronary heart disease. Clinical research evidence tends to support the therapeutic effect of Yiqifumai injection combined with conventional Western medicine in improving heart failure patients' heart function and quality of life. However, there are also issues such as low overall quality of research, unreasonable clinical trial design, small sample size, incomplete selection of outcome indicators, low international recognition of certain outcome indicators, and lack of reporting on long-term outcomes The overall quality of randomized controlled trials andsystematic evaluation methodology is low. CONCLUSION: In the future, more large sample, multicenter clinical randomized controlled trials should be conducted to obtain higher-level evidence-based medicine evidence to fully demonstrate the advantages of traditional Chinese medicine treatment, and promote the common development of traditional Chinese medicine cardiology and evidence-based medicine.

Key words: Yiqifumai injection, heart failure, evidence map, clinical research

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