随机临床试验中的微观结肠炎组织学评估中的异质性:一个总体审查
Yuhong Yuan1,2, Kato Vanden Kerchove3, Christopher Ma4,5
1Department of Medicine, London Health Science Center, London, Ontario, Canada.
微观结肠炎 (MC) 的组织学结果缺乏标准化的定义,阻碍了临床试验. 这次审查发现,随机对照试验 (RCT) 中组织学评估的定义和监测方式存在显著差异.
科学领域:
- 胃肠病学 胃肠病学
- 病理学 病理学 病理学
- 临床试验 临床试验
背景情况:
- 微观结肠炎 (MC) 诊断依赖于内镜活检和组织学评估.
- 组织学结果是MC临床试验的关键目标.
- 目前的研究缺乏MC组织学结果的标准化标准.
研究的目的:
- 在干预措施的系统性审查 (SRs) 中审查和总结MC的组织学评估.
- 检查这些SR中随机对照试验 (RCT) 中组织学评估的异质性.
主要方法:
- 对已发表的SR进行了总体审查.
- 在Cochrane,MEDLINE和Embase搜索到2025年5月.
- 从SR和包括RCT中提取并总结了组织学评估和监测的定义.
主要成果:
- 包括14个SR与元分析和19个RCT.
- 十二个RCT报告了组织学结局数据.
- 组织学结果的定义各不相同,通常是基于膜自身细胞性,内皮质淋巴细胞或原带厚度的减少.
结论:
- 突出了MC RCT组织学结果定义中的异质性.
- 总结的证据支持开发MC组织学结果的共识定义.
- 旨在促进MC疗法的未来临床试验.
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