在患有渐进性肺纤维化患者中使用Nerandomilast
Toby M Maher1,2, Shervin Assassi3, Arata Azuma4,5
1Department of Pulmonary, Critical Care, and Sleep Medicine, Keck School of Medicine, University of Southern California, Los Angeles.
The New England journal of medicine
|May 19, 2025
概括
在52周内,内兰多米拉斯特显著减缓了慢性肺纤维化患者强迫生命能力 (FVC) 的下降. 这种固酶4B抑制剂为渐进性肺纤维化提供了一个新的治疗选择.
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.
背景情况:
- 尼兰多米拉斯特是一种口服化酶4B抑制剂,具有抗纤维和免疫调节作用.
- 之前的研究表明在异常性肺纤维化中有效;它对其他渐进性肺纤维化类型的影响需要调查.
研究的目的:
- 评估Nerandomilast在患有渐进性肺纤维化患者的疗效和安全性.
主要方法:
- 第三阶段,双盲试验涉及1176名肺纤维化进展的患者.
- 患者接受了纳兰多米拉斯特 (18毫克或9毫克每天两次) 或安慰剂.
- 主要终点:52周,强迫生命能力 (FVC) 与基线的绝对变化.
主要成果:
- 与安慰剂 (-165.8毫升) 相比,Nerandomilast 18毫克和9毫克组在52周内显示出较小的FVC下降 (-98.6毫升和-84.6毫升),与安慰剂 (-165.8毫升) 相比.
- 这两种差异在随机剂和安慰剂的两种剂量中都具有统计学意义 (P<0.001).
- 腹是最常见的不良事件;严重的不良事件在各组中是相似的.
结论:
- 与安慰剂相比,Nerandomilast治疗在52周的慢性肺纤维化患者中导致FVC显著减少.
- 涅兰多米拉斯特显示出作为治疗渐进性肺纤维化的潜力.
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