代谢功能障碍相关的脂肪肝炎临床试验中的安慰剂率:系统性审查和元分析
Francisco Idalsoaga1, Luis Antonio Díaz2, Saleh Alghsoon3
1Departamento de Gastroenterología, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
概括
在代谢功能障碍相关的脂肪肝炎 (MASH) 试验中,高安慰剂反应率是常见的. 本次元分析量化了这些率,为MASH药物开发中的未来临床试验设计提供了洞察力.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 临床试验设计 临床试验设计
- 药理学 药理学是指药理学的学科.
背景情况:
- 在代谢功能障碍相关的脂肪肝炎 (MASH) 临床试验中,高的安慰剂反应率构成了重大挑战.
- 了解安慰剂反应的变异性对于准确评估MASH中药物的疗效至关重要.
研究的目的:
- 在MASH临床试验中量化安慰剂反应率.
- 确定影响安慰剂反应的患者和试验设计因素.
主要方法:
- 对MASH干预的安慰剂控制试验进行系统的元分析.
- 在 MEDLINE,Embase 和 CENTRAL 搜索到 2025 年 5 月.
- 使用随机效应模型和元回归分析汇集的安慰剂反应率.
主要成果:
- 在非脊髓炎的安慰剂患者中,没有纤维化恶化的集体MASH解析率为11% (95% CI,8%-14%).
- 没有显著的患者或试验特征与安慰剂反应相关.
- 二级结局结果显示正常ALT (12%) 和肝脏脂肪减少率较高 (22%绝对,19%相对).
结论:
- 在MASH试验中,安慰剂反应率很大,但根据结果而异.
- 结果提供了关键数据,以告知和优化未来的MASH临床试验设计.
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