开发一套核心结果,用于临床试验的传统中医的腰椎椎间板的临床试验
Xiaokuan Qin1, Kai Sun2, Xiangyu Xiao3
1Beijing Key Laboratory of Digital Intelligence Traditional Chinese Medicine for Preventing and Treating Degenerative Bone and Joint Diseases, China Academy of Chinese Medical Sciences, Wangjing Hospital, Beijing, China.
Journal of evidence-based medicine
|January 29, 2026
概括
一个新的核心结果集 (COS) 标准化了传统中医 (TCM) 临床试验管理腰椎间盘 (LDH) 的报告. 这提高了研究的一致性和证据综合,以获得更好的TCM-LDH治疗方法.
科学领域:
- 综合医学是一个整体的医学.
- 临床试验方法论 临床试验方法论
- 基于证据的实践.
背景情况:
- 传统中医 (TCM) 经常用于腰椎间盘 (LDH).
- 在TCM-LDH试验中不一致的结果报告使证据综合复杂化.
- 为了提高TCM-LDH研究质量,需要一个标准化的核心成果集 (COS).
研究的目的:
- 开发基于共识的核心成果集 (COS) 进行临床试验的传统中医 (TCM) 对腰椎间盘 (LDH) 的干预措施.
- 在TCM-LDH研究中标准化结果报告.
- 提高TCM在LDH管理中的证据的质量和可比性.
主要方法:
- 系统审查TCM-LDH随机对照试验 (RCT) 和临床试验注册表.
- 与LDH患者进行定性采访,并与临床医生进行调查.
- 两轮德尔菲调查和与多学科专家的共识会议.
主要成果:
- 一项系统性审查确定了来自413个RCT和51个注册研究的候选结果.
- 患者采访和临床医生调查完善了结果池.
- 确定了七个核心结局:腰部功能障碍,疼痛,复发率,直腿升高角度,不良事件,TCM综合征和坐骨 sciatica 频率.
结论:
- 开发的COS为TCM-LDH试验的结果选择和报告提供了标准化的建议.
- 这种标准化将提高研究的一致性,并促进元分析.
- 该COS旨在提高椎间盘的TCM基干预措施的质量.
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