相关实验视频
在有症状的慢性阻塞性肺病中使用Roflumilast:两项随机临床试验
Peter M A Calverley1, Klaus F Rabe, Udo-Michael Goehring
1School of Clinical Sciences, Liverpool, UK. pmacal@liverpool.ac.uk
Lancet (London, England)
|September 1, 2009
概括
作为一种固酶-4抑制剂的罗夫卢米拉斯降低了慢性阻塞性肺病 (COPD) 患者中适度或严重恶化的发生率. 这项研究突出了罗夫卢米拉斯的重要意义.
科学领域:
- 肺部医学 肺部医学
- 药理学 药理学是指药理学的学科.
背景情况:
- 慢性阻塞性肺病 (COPD) 是致病率和死亡率的主要原因之一.
- 作为一种固酶-4抑制剂的罗夫卢米拉斯特已显示出改善COPD患者肺功能和减少COPD患者恶化的潜力.
- 目前的研究调查了罗夫米拉斯特在减少COPD中需要皮质类固醇的恶化方面的疗效.
研究的目的:
- 评估罗夫卢米拉斯特对COPD患者需要皮质类固醇治疗的恶化频率的影响.
- 为了评估罗夫卢米拉斯特对肺功能的影响,特别是1秒内强迫呼气量 (FEV(1) 的前支气管扩展剂.
主要方法:
- 两个相同的,安慰剂控制,双盲,多中心试验 (M2-124和M2-125) 在门诊环境中进行.
- 患有COPD的患者 (年龄大于40岁,严重的气流限制,支气管炎症状,病史恶化) 接受了口服罗米拉斯特 (500微克/天) 或安慰剂52周.
- 主要终点包括支气管扩展前FEV变化和中度或重度恶化率. 进行了治疗意向分析.
主要成果:
- 聚合分析显示,与安慰剂相比,使用罗夫卢米拉斯特的前支气管扩展剂FEV (p<0.0001) 显著增加了48毫升 (p<0.0001).
- 每年每名患者中度或重度恶化的发病率在罗夫米拉斯特治疗中减少了17% (1.14对1.37;p<0.0003).
- 与安慰剂 (62%) 相比,使用罗夫卢米拉斯特 (67%) 的不良事件更频繁,导致分别在14%和12%的患者中断治疗. 在使用roflumilast时,观察到平均体重减轻2.17公斤.
结论:
- 罗夫米拉斯在特定的COPD患者子组中有效降低了恶化率.
- 向治疗,包括罗米拉斯,可以改善COPD的治疗.
- 进一步的前性研究是有必要的,以探索针对性治疗的潜力,在COPD.
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