临床决策支持工具的回顾性验证,用于预测Vedolizumab治疗的炎症性肠病患者的有效性结果
Paul A G de Klaver1, Amber M H van Woerkens1,2, Hedwig M A D'Agnolo3
1Department of Clinical Pharmacy and Pharmacology, Máxima Medical Center, 5504 DB Veldhoven, The Netherlands.
Pharmaceutics
|January 28, 2026
概括
一个临床决策支持工具准确地预测了在性结肠炎 (UC) 患者中vedolizumab治疗的有效性. 然而,该工具没有显示克罗恩病的预测价值.
科学领域:
- 胃肠病学 胃肠病学
- 药理学 药理学是指药理学的学科.
- 临床信息学 临床信息学
背景情况:
- 开发了两种临床决策支持工具 (CDST),以预测克罗恩病 (CD) 和性结肠炎 (UC) 中的vedolizumab治疗疗效.
- 来自荷兰教学医院的现实数据被用于验证这些CDST.
- 该研究还评估了使用ustekinumab治疗患者的CDSTs的特异性.
研究的目的:
- 用现实数据验证两个CDST对CD和UC患者的vedolizumab治疗的预测准确性.
- 评估CDST在预测临床缓解,生化缓解,复合缓解和无皮质类固醇缓解方面的表现.
- 评估CDSTs在基于预测概率的基础上区分治疗反应的能力.
主要方法:
- 对32名CD和41名UC患者的回顾性分析,这些患者接受了vedolizumab治疗 (2014年10月至2023年7月).
- 纳入28名用乌斯特基努马布治疗的CD患者和41名用维多利祖马布治疗的UC患者进行特异性评估.
- 主要结局包括临床缓解 (CREM),生化缓解 (BioREM),复合缓解 (CompREM) 和14周,30周和54周的无皮质类固醇临床缓解 (CSF-CREM).
主要成果:
- 在接受vedolizumab的UC患者中,高预测响应概率与54周的CREM,CompREM和CSF-CREM的更高率显著相关 (p < 0.001).
- 在第54周,UC患者的缓解率在高概率组 (例如,CREM 81.8%与33.3%) 显著更高.
- 在CD患者 (接受vedolizumab或ustekinumab治疗) 的低/中等和高概率组之间没有观察到统计学上显著的结果差异.
结论:
- 针对UC的CDST证明了vedolizumab治疗有效性的预测价值,有助于患者选择UC.
- 该CDST是优化vedolizumab治疗选择性结肠炎的一个有价值的工具.
- 对于接受vedolizumab的克罗恩病患者,CDST的预测能力没有得到验证.
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