罗夫卢米拉斯特对重症慢性阻塞性肺病患者的恶化影响,这些患者无法通过组合治疗 (REACT) 控制:多中心随机对照试验
Fernando J Martinez1, Peter M A Calverley2, Udo-Michael Goehring3
1Weill Cornell Medical College, New York, NY, USA; University of Michigan Health System, Ann Arbor, MI, USA.
Lancet (London, England)
|February 17, 2015
概括
在重症慢性阻塞性肺病患者接受吸入性皮质类固醇和长效β抗原剂治疗时,罗夫卢米拉斯特显著减少了恶化. 这一发现支持roflumilast作为高风险患者的宝贵补充治疗.
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:
- 严重的慢性阻塞性肺病 (COPD) 的特点是频繁恶化.
- 目前的治疗方法,包括吸入性皮质类固醇 (ICS) 和长效β-激动剂 (LABA),可能无法完全控制所有患者的恶化.
- 作为已经接受ICS/LABA组合治疗的患者的补充疗法,罗米拉斯的疗效以前是未知的.
研究的目的:
- 评估罗夫卢米拉斯特在减少重度COPD患者接受背景ICS/LABA治疗的恶化症的疗效.
- 为了评估添加roflumilast到ICS/LABA治疗的安全性和耐受性.
主要方法:
- 一年,双盲,安慰剂控制,多中心的3-4期试验 (REACT研究) 涉及1945名严重COPD患者.
- 患者被随机分配1:1接受每天一次口服罗米拉斯特500微克或安慰剂,除了他们现有的ICS/LABA联合治疗外.
- 主要结局是每名患者每年的中度至重度COPD恶化率,按治疗意图进行分析.
主要成果:
- 罗夫卢米拉斯特在使用负二项回归的过程中,与安慰剂 (p=0.0424) 相比,对中度至重度的COPD恶化病例的统计学显著减少了14.2%.
- 虽然初级Poisson回归分析显示了13.2%的减少 (p=0.0529),但灵敏度分析证实了好处.
- 在罗弗米拉斯特组中,不良事件发生频率更高 (67%vs. 59%),戒断率更高 (11%vs. 5%).
结论:
- 罗夫米拉斯在高风险的慢性支气管炎严重的COPD患者中有效减少恶化和住院,即使在使用ICS/LABA和潜在的tiotropium治疗时也是如此.
- 在ICS/LABA疗法中添加罗夫卢米拉斯特为治疗严重的COPD频繁恶化提供了潜在的治疗选择.
- 增加的不良事件在这个人群中开始使用罗米拉斯特时需要仔细监测患者.
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