中医药治疗颈源性头痛随机对照试验结局指标与核心指标构建思路研究
DOI:
CSTR:
作者:
作者单位:

作者简介:

通讯作者:

中图分类号:

R246.9

基金项目:

广州市科技计划项目(202102080347);广州中医药大学“固本”工程一级学科能力提升项目(体育学学科06);2024年广州中医药大学高等教育教学研究和改革项目


Study on Outcome Indicators and Core Indicator Construction Ideas of Randomized Controlled Trials for Traditional Chinese Medicine in the Treatment of Cervicogenic Headache
Author:
Affiliation:

Fund Project:

  • 摘要
  • |
  • 图/表
  • |
  • 访问统计
  • |
  • 参考文献
  • |
  • 相似文献
  • |
  • 引证文献
  • |
  • 资源附件
  • |
  • 文章评论
    摘要:

    目的:分析中医药治疗颈源性头痛(CEH) 随机对照试验(RCT) 中的结局指标现状,找出存在 的问题,为临床结局指标选择以及核心结局指标集构建提供思路。方法:采用计算机检索国内外8个数据库, 收集中医药治疗CEH的RCT,经二轮筛选文献、数据提取后,采用Cochrane工作组制定的偏倚风险评估工 具(ROB) 对纳入文献进行偏倚风险评价,并对结局指标进行统计学分析。结果:共纳入47 项RCTs,包 含46篇中文与1篇英文文献,总样本量4 352例。结局指标涵盖5类69种,报告率前3位分别为视觉模拟评分 法(VAS) 评分(74.47%)、颈椎活动度(ROM) 评分(44.68%)、《中医病证诊断疗效标准》(38.30%);与 CEH临床特征、发病机制相关的结局指标报告率相对较高,如疼痛指标VAS评分、关节活动度类指标、生活 质量类指标及炎症因子指标。在结局指标设定方面,仅1 篇文献明确区分主次结局指标。偏倚风险方面, 26 篇文献未提及随机分组产生方法,43篇文献未提及盲法实施情况。结论:中医药治疗CEH的RCT在结局指 标选择应用上,虽具有关注临床特征与发病机制的优势,但存在主次结局不清、随机设计与盲法应用不足、客 观评价指标少、缺乏中医药特色及经济学指标等问题。建议遵循有效性试验核心结局指标(COMET) 倡议建 立核心指标集,明确构建路径,包括形成候选指标池、组建多学科专家组、开展德尔菲法调研及召开共识会 议,强化方法学设计,增加客观及特色指标,提升中医药临床研究价值。

    Abstract:

    Abstract: Objective: This study aims to analyze the current status of outcome indicators in randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for cervicogenic headache (CEH), identify existing problems, and provide insights for the selection of clinical outcome indicators and the construction of a core outcome set. Methods:Eight domestic and international databases were searched by computer to collect RCT of TCM for CEH. After two rounds of literature screening and data extraction,the Risk of Bias (ROB) assessment tool developed by the Cochrane Collaboration was used to evaluate the risk of bias of the included literature, and statistical analysis was conducted on the outcome indicators. Results:A total of 47 RCTs were included,consisting of 46 Chinese articles and 1 English article,with a total sample size of 4 352 cases. The outcome indicators covered 5 categories and 69 types. The top 3 reporting rates were Visual Analogue Scale (VAS) (74.47%),cervical range of motion (ROM) (44.68%), and Diagnostic and Therapeutic Criteria for TCM Diseases and Syndromes (38.30%). Outcome indicators related to the clinical characteristics and pathogenesis of CEH had relatively high reporting rates,such as VAS score of pain,joint ROM indicators, quality of life indicators, and inflammatory factor indicators. Regarding the setting of outcome indicators, only 1 article clearly distinguished between primary and secondary outcome indicators. In terms of risk of bias, 26 articles did not mention the method of generating random grouping, and 43 articles did not mention the implementation of blinding. Conclusion: Although RCT of TCM for CEH has the advantage of focusing on clinical characteristics and pathogenesis in the selection and application of outcome indicators, there are problems such as unclear primary and secondary outcomes, insufficient application of random design and blinding, relatively few objective evaluation indicators, and lack of TCM-specific and economic indicators. It is recommended to establish a core outcome set in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) initiative and clarify the construction path, including forming a candidate indicator pool, establishing a multidisciplinary expert group, conducting Delphi surveys, and holding consensus meetings. This will strengthen methodological design, increase objective and characteristic indicators,and enhance the value of TCM clinical research.

    参考文献
    相似文献
    引证文献
引用本文

罗茜子,陈楚杰,陈如玉,王新茹,郑可耀,陈玉,王鑫.中医药治疗颈源性头痛随机对照试验结局指标与核心指标构建思路研究[J].新中医,2025,57(23):182-189

复制
分享
相关视频

文章指标
  • 点击次数:
  • 下载次数:
  • HTML阅读次数:
  • 引用次数:
历史
  • 收稿日期:
  • 最后修改日期:
  • 录用日期:
  • 在线发布日期: 2025-12-12
  • 出版日期:
文章二维码