开发一套核心结果,用于针对类风湿性关节炎的中国传统医学的临床试验
Bingbing Yu1, Mengge Song1, Jingdong Yang2
1Division of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Frontiers in medicine
|December 24, 2025
概括
为了在临床试验中标准化结果测量,开发了一套新的传统中医风湿关节炎核心结果集 (COS-TCM-RA). 这种标准化框架提高了试验质量,并支持将TCM纳入基于证据的医学.
科学领域:
- 类风湿病学 类风湿病学
- 传统中国医药 传统中国医药
- 临床试验方法论 临床试验方法论
背景情况:
- 结果测量和报告的异质性使传统中医 (TCM) 对类风湿性关节炎 (RA) 的临床试验复杂化.
- 需要一个标准化的核心成果集 (COS),以提高TCM-RA研究的质量和可比性.
研究的目的:
- 开发一种基于共识的中医传统医学在类风湿性关节炎 (COS-TCM-RA) 临床试验的核心成果集.
- 解决现有研究中结果测量和报告的异质性.
主要方法:
- 一项系统性审查确定了69项符合条件的TCM-RA研究报告的结果.
- 半结构面试收集了患者对重要结果的看法.
- 一个三轮的德尔菲调查和一个专家的共识会议精细化和优先考虑的结果.
主要成果:
- 从系统性审查中生成了52个独特结果的初步列表.
- 最终的COS-TCM-RA包括五个领域的11个指标:整体疾病评估,物理和化学指标,生活质量,TCM综合征和不良事件.
- 关键结果包括医生对全球状况的评估,临床实验室测试,放射性评估,症状,生活质量和安全事件.
结论:
- 第一个COS-TCM-RA成功开发,提供了一个标准化,多维的框架.
- 该COS将国际公认的RA评估工具与患者报告的结果和TCM特定措施相结合.
- COS-TCM-RA旨在提高试验质量,提高可比性,并支持TCM在基于证据的医学中的整合和国际化.
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