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在牛皮和牛皮关节炎的药物试验中,指标的相对敏感性和偏好

Shuntong Kang^1,2,3,4,5, Dingyao Zhang^6,7, Yaqing Huang⁸

¹Key Laboratory of Shaanxi Province for Craniofacial Precision Medicine Research, College of Stomatology, Xi'an Jiaotong University, Xi'an, China.

European journal of medical research

|August 26, 2025

概括

选择牛皮和牛皮关节炎试验的最佳结果指标至关重要. PASI 75和IGA 0. 1对于牛皮具有强大作用,而PASI 50,75,90和ACR 20则对牛皮关节炎具有有效作用.

科学领域:

关节病学
皮肤病学
临床试验方法

背景情况:

对于牛皮 (Pso) 和牛皮关节炎 (PsA) 的随机临床试验 (RCT) 存在许多疗效指标.
这些指标之间的可比性和相关性尚未得到充分证实.
对Pso和PsA试验的主要终点的最佳选择需要进一步调查.

研究的目的:

评估Pso和PsaRCT中常用的反应率指标的偏好和相对敏感性.
为未来Pso和PsA临床试验选择主要终点提供指导.
提高有效性指标的可比性和相关性理解.

主要方法:

在五个数据库和四个注册表中系统搜索药物干预控制的RCT.
应用贝叶斯层次线性混合模型来评估指标歧视和排名.
估计对照组和干预组之间的差异,以评估指标偏好和敏感性.

主要成果:

包括386个RCT,分析了Pso的9个指标和PsA的8个指标.
对于Pso,PASI 50,PASI 75和IGA 0. 1的有效性评估显示出强大.
对于PSA,PASI 50,PASI 75,PASI 90和ACR 20显示出高效率,ACR 20被推以防止过度估计;ACR 50,ACR 70和MDA不那么敏感,但更加谨慎.

结论:

在Pso和PsA中,指标选择对治疗疗效的评估有重大影响.
选择主要结果的灵活性和全面性对于试验设计至关重要.
结果为优化指标选择提供了实际指导,以与试验目标和疾病特征保持一致.

关键词:

结果通过50 牛皮牛皮关节炎随机临床试验

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