DPP-1 抑制剂 Brensocatib 在支气管切除症的第三阶段试验
James D Chalmers1, Pierre-Régis Burgel2,3, Charles L Daley4,5
1Division of Respiratory Medicine and Gastroenterology, University of Dundee, Dundee, United Kingdom.
The New England journal of medicine
|April 23, 2025
概括
布伦索卡提布显著减少了支气管切除症患者的肺部恶化. 与安慰剂相比,25毫克剂量也显示肺功能 (FEV1) 的下降速度较慢.
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:
- 支气管炎症中性质炎症增加了恶化的风险和疾病的进展.
- 布伦索卡提布 (Brensocatib) 是一种口服的二乙酶1 (DPP-1) 抑制剂,向中性粒细胞血清蛋白酶.
研究的目的:
- 评估brensocatib在减少支气管切除症患者肺部恶化方面的疗效和安全性.
- 评估布伦索卡提布对肺功能 (FEV1) 和生活质量的影响.
主要方法:
- 第三阶段,双盲,随机试验,涉及1721名支气管切除症患者.
- 患者接受布伦索卡提布 (每天10毫克或25毫克) 或安慰剂52周.
- 主要终点:肺部恶化的年率;次要终点包括第一次恶化的时间,FEV1变化和生活质量.
主要成果:
- 与安慰剂相比,brensocatib (10 mg和25 mg) 显著降低了肺部恶化病例的年均率 (分别为0.79和0.81的比率).
- 在接受布伦索卡提布治疗52周后,更高比例的患者保持无恶化 (48.5%) 与安慰剂 (40.3%) 相比.
- 与安慰剂 (-62毫升) 相比,25毫克的布伦索卡提布剂量显示FEV1 (-24毫升) 的下降较小. 超球症在brensocatib治疗中更为频繁.
结论:
- 每天服用一次布伦索卡提布 (10毫克或25毫克) 有效地降低了支气管切除症患者的肺部恶化年率.
- 与安慰剂相比,25毫克的布伦索卡提布剂量对肺功能产生了有益影响,FEV1的下降较小.
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