在患有异常性肺纤维化患者中使用Nerandomilast
Luca Richeldi1, Arata Azuma2,3, Vincent Cottin4
1Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome.
The New England journal of medicine
|May 19, 2025
概括
在52周内,内兰多米拉斯在异常性肺纤维化患者的肺功能下降速度较慢. 这种固酶4B抑制剂在一个大型的第三期试验中,与安慰剂相比,显示出显著的益处.
科学领域:
- 肺部病理学 肺部病理学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 尼兰多米拉斯特是一种口服化酶4B抑制剂,具有已证明的抗纤维素和免疫调节性质.
- 之前的第二阶段试验表明,内兰多米拉斯可以稳定12周内异常性肺纤维化 (IPF) 患者的肺功能.
研究的目的:
- 评估在患有异常性肺纤维化 (IPF) 的患者中内兰多米拉斯特的疗效和安全性.
- 在52周的时间内确定内兰多米拉斯对肺功能下降速度的影响.
主要方法:
- 一个第三阶段的双盲随机试验,涉及1177名IPF患者.
- 患者被分配1:1:1分,每天两次接受18毫克随机,9毫克随机或安慰剂.
- 分层是基于背景抗纤维治疗 (nintedanib/pirfenidone或没有);主要终点是52周强迫生命能力 (FVC) 的变化.
主要成果:
- 与安慰剂相比,52周内Nerandomilast治疗导致FVC的调整平均下降幅度较小 (-18 mg -114.7 ml,9 mg -138.6 ml与安慰剂 -183.5 ml).
- 这些差异具有统计学意义:18毫克组的68.8毫升 (P<0.001) 和9毫克组的44.9毫升 (P=0.02) 与安慰剂相比.
- 腹是最常见的不良事件 (18毫克组41.3%,9毫克组31.1%,安慰剂组16.0%);严重的不良事件是平衡的.
结论:
- 与安慰剂相比,Nerandomilast在52周内显著减缓了异常性肺纤维化患者强迫生命能力 (FVC) 的下降.
- 这些发现支持无机作为管理IPF的潜在治疗选择,而腹是显著的副作用.
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