主 办:北 京 中 医 药 大 学
ISSN 1006-2157 CN 11-3574/R

北京中医药大学学报 ›› 2020, Vol. 43 ›› Issue (7): 606-616.doi: 10.3969/j.issn.1006-2157.2020.07.013

• 临床研究 • 上一篇    

近3年中医药治疗稳定型心绞痛随机对照试验结局指标的现状分析*

李慧敏1, 熊兴江2, 赵晖3, 胡瑞学1, 商洪才4, 杨伟1, 廖星1#   

  1. 1 中国中医科学院中医临床基础医学研究所 北京 100700;
    2 中国中医科学院广安门医院;
    3 中国中医科学院中国中医药循证医学中心;
    4 北京中医药大学东直门医院
  • 收稿日期:2019-12-20 发布日期:2020-08-11
  • 通讯作者: #廖星,女,博士,研究员,博士生导师,主要研究方向:中医药循证评价方法学研究,E-mail:okfrom2008@hotmail.com
  • 作者简介:李慧敏,女,在读硕士生
  • 基金资助:
    *国家重点研发计划项目(No.2017YFC1700400,No.2017YFC1700406-2),国家自然科学基金面上项目(No.81774159),中国中医科学院基本科研业务费优秀青年科技人才(创新类)培养专项(No. ZZ13-YQ-075),中国中医科学院中央级公益性科研院所基本科研业务费自主选题(第十三批)项目(No. Z0650)

Analysis of outcomes used in RCTs of traditional Chinese medicine on stable angina pectoris in the past 3 years*

Li Huimin1, Xiong Xingjiang2, Zhao Hui3, Hu Ruixue1, Shang Hongcai4, Yang Wei1, Liao Xing1#   

  1. 1 Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
    2 Guang'anmen Hospital, China Academy of Chinese Medical Sciences;
    3 China Center for Evidence Based Traditional Chinese Medicine, China Academy of Chinese Medical Sciences;
    4 Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100070, China
  • Received:2019-12-20 Published:2020-08-11
  • Contact: Dr. Liao Xing,Doctoral Supervisor. 16 Dongzhimennei Nanxiaojie, Dongcheng District, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China. E-mail: okfrom2008@hotmail.com
  • Supported by:
    National Key Research and Development Plan (No.2017YFC1700400,No.2017YFC1700406-2); National Natural Science Foundation of China (No. 81774159);the Fundamental Research Funds for the Central public welfare research institutes(No.ZZ13-YQ-075,No.Z065)

摘要: 目的 通过评价目前中医药治疗稳定型心绞痛随机对照试验中结局指标的选择现状,为未来相关研究提供依据和基础。方法 计算机检索 PubMed、Embase、Cochrane Library、CBM、CNKI、WanFang Data 和 VIP 数据库,搜集中医药治疗稳定型心绞痛的随机对照试验(randomized controlled trial,RCT),检索时限均从 2016 年1月—2019年8月。按照预先制定的遴选标准筛选出中医药治疗稳定型心绞痛的RCT,并根据Cochrane偏倚风险评估工具对纳入研究进行质量评价。由2位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用定性分析的方法描述纳入研究的结局指标情况。结果 初步检索出6 349篇相关文献,最终纳入24篇文献,包括3篇英文文献。 24个RCT的结局指标主要分为七大类,即心绞痛疗效指标、心电图指标、生活质量量表、血生化指标、安全性指标(包括不良反应和不良事件)、中医证候疗效指标、其他指标。血生化指标为出现频次最高的指标,心绞痛疗效指标次之。24个研究中有14个研究使用了中医证候疗效作为疗效结局指标。结论 对中医药治疗稳定型心绞痛的RCT结局指标遴选现状堪忧并存在较多问题,应该借鉴核心指标集的创建方法,构建符合中医药治疗措施、疗效特色的核心指标集。

关键词: 中医药, 稳定型心绞痛, 随机对照试验, 结局指标

Abstract: Objective To evaluate the outcomes used in randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in the treatment of stable angina pectoris, and to provide a basis for the study of the core outcome set of TCM in the treatment of stable angina pectoris. Methods We searched RCTs of TCM in the treatment of stable angina pectoris in the databases of PubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data and VIP from January 2016 to August 2019. Two reviewers independently screened all the records, extracted the data and evaluated the risk of bias for the included trials. A qualitative analysis was conducted to describe the outcomes of the included studies. Results 6349 papers were searched and screened. 24 papers (3 English papers) were included in the final analysis. Outcomes used in these 24 studies were mainly divided into six categories, namely clinical efficacy of angina pectoris, electrocardiogram (ECG), Quality of life (QoL) scale, blood biochemistry panel, safety profiles (including adverse reactions and adverse events), and other parameters. Blood biochemical parameters topped the list, followed by angina pectoris. 14 of the 24 studies used TCM syndrome scores as an indicator of outcome. Conclusion There are existing problems in the outcomes used in RCTs of TCM treatment of stable angina pectoris. We should establish core outcome set for TCM studies on the basis of combining the international standardized core outcome set with the characteristics and laws of diagnosis and treatment of traditional Chinese medicine.

Key words: traditional Chinese medicine, stable angina pectoris, randomized controlled trial, outcome measurements

中图分类号: 

  • R2-031