慢性阻塞性肺部疾病 (TRINITY) 的单个吸入器外精三重治疗与长期作用的肌抗体治疗:双盲,并行组,随机对照试验
Jørgen Vestbo1, Alberto Papi2, Massimo Corradi3
1Division of Infection, Immunity and Respiratory Medicine, University of Manchester, Manchester, UK; University Hospital South Manchester NHS Foundation Trust, Manchester, UK; Medicines Evaluation Unit, Manchester, UK.
Lancet (London, England)
|April 8, 2017
概括
固定的三重疗法,结合吸入性皮质类固醇和两种长效支气管扩展剂,与tiotropium相比,减少了COPD患者的恶化. 这种治疗还改善了肺功能,为症状慢性阻塞性肺病提供了临床益处.
科学领域:
- 肺病学
- 呼吸系统医学
- 临床试验
背景情况:
- 关于COPD三重疗法的有效性存在有限的数据.
- 这项研究比较了固定的三重疗法 (贝克罗梅他松二,福莫特醇 fumarate,糖皮隆) 与tiotropium和开放的三重疗法.
研究的目的:
- 在COPD患者中比较固定的三重治疗与tiotropium和开放的三重治疗的疗效.
- 评估对中度至重度恶化和肺功能 (FEV1) 的影响.
主要方法:
- 这是一项双盲随机对照试验,涉及2691名COPD患者.
- 患者FEV1 < 50%,在12个月内至少出现一次恶化,CAT分数>=10.
- 治疗包括固定三倍,tiotropium,或开放三倍52周.
主要成果:
- 固定的三重疗法显示中度至重度恶化率明显低于tiotropium (0. 46对0. 57).
- 与tiotropium相比,固定三重疗法在52周后改善了剂前FEV1.
- 固定的三重疗法在改善FEV1方面不低于开放的三重疗法.
结论:
- 在具有低FEV1和恶化病史的症状性COPD患者中,extrafine固定的三重疗法比tiotropium具有临床益处.
- 这项TRINITY研究提供了支持固定的三重疗法的证据,用于管理特定的COPD患者群体.
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