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支气管透视肺体积减小与呼吸道支架用于肺 (EASE试验):随机化,假控制,多中心试验试验
P L Shah1, D-J Slebos, P F G Cardoso
1National Institute for Health Research Respiratory Biomedical Research Unit at Royal Brompton and Harefield NHS Foundation Trust, Imperial College, London, UK. pallav.shah@imperial.ac.uk
Lancet (London, England)
|September 13, 2011
概括
使用帕克利塔塞尔涂层支架的气道绕道治疗对严重肺气患者没有显示可持续的益处. 虽然该程序是安全的,但与虚假治疗相比,该程序并没有显著改善肺功能或减少呼吸困难.
科学领域:
- 肺部医学 肺部医学
- 干预性肺病学 干预性肺病学
- 呼吸系统疾病研究 呼吸系统疾病研究
背景情况:
- 肺是一种严重的肺部疾病,其特点是捕捉空气,影响呼吸机制.
- 气道旁路是一种支气管镜肺体积减小技术,使用帕克利塔塞尔涂层支架来缓解症状.
- 在EASE (呼吸呼吸道支架治疗肺瘤) 试验中,研究了这种治疗严重同质肺瘤的方法.
研究的目的:
- 评估呼吸道绕道治疗在患有严重同质肺气的患者中的安全性和有效性.
- 为了确定空气道绕道是否在改善肺功能和减少呼吸障碍方面提供可持续的好处.
主要方法:
- 这是一项随机,双盲,假控制的研究,涉及38个全球中心的315名严重高通胀患者.
- 患者被分配为2:1的气道旁路或假控制,随访12个月.
- 6个月后的共同初级疗效终点包括强迫生命能力 (FVC) 和呼吸障碍得分的改善;安全性通过严重不良事件进行评估.
主要成果:
- 在6个月后的共同初级疗效终点 (后期概率为0.749) 中,没有观察到气道绕道和假控制之间的显著差异.
- 该程序被认为是安全的,复合初级安全终点被认为不低于假控制 (后置概率1.00).
- 观察到过渡性改善,但在这个患者队列中,空气道绕道治疗没有证明有可持续的益处.
结论:
- 气道绕道在患有严重同质肺气的患者中显示出安全性.
- 该程序在肺功能或呼吸障碍减少方面没有提供可持续的临床益处.
- 可能需要进一步的研究来探索用于肺缩的替代策略.
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