在慢性阻塞性肺病 (TRIBUTE) 中,吸入式三重治疗与双重支气管扩展剂治疗:双盲,并行组,随机对照试验
Alberto Papi1, Jørgen Vestbo2, Leonardo Fabbri3
1Research Centre on Asthma and COPD, University of Ferrara, Ferrara, Italy.
与双重支气管扩张相比,吸入贝克洛马二酸盐,形式醇烟酸和糖 (BDP/ FF/ G) 的三重治疗显著降低了中度至重度的COPD恶化. 这一发现支持重度COPD症状和病史恶化患者的三重治疗.
科学领域:
- 呼吸系统医学
- 药理学
背景情况:
- 关于吸入三重治疗与双重支气管扩张的风险益处的证据有限.
- 三重疗法结合了吸入性皮质类固醇,长效肌抗体和长效β2抗体.
研究的目的:
- 为了比较单个吸入器的三重疗法 (贝克罗梅他二酸盐/格洛酸盐/糖皮龙 - BDP/FF/G) 与单个吸入器的双重支气管扩展剂 (英达卡特罗尔/糖皮龙 - IND/GLY).
- 在52周内评估中度至重度COPD恶化的发生率.
主要方法:
- 一个随机的,并行组,双盲,双模拟研究,涉及1532名有症状的COPD和严重的气流限制的患者.
- 患者每天接受两次额外细分BDP/ FF/ G或每天一次IND/ GLY,持续52周.
- 主要终点是中度至重度COPD恶化的发生率.
主要成果:
- 与IND/GLY (0. 59) 相比,BDP/FF/G的中度至严重恶化的发生率较低,这是统计学上显著的差异 (发生率比率为0. 848,p=0. 043).
- 在不同组中,不良事件的发生率相似 (64%为BDP/ FF/ G,而IND/ GLY为67%).
- 肺炎发病率相似 (4% 在两组).
结论:
- 与IND/GLY相比,在有症状的患者中,BDP/FF/G显著降低了中度至重度的COPD恶化.
- 三重治疗没有增加肺炎的风险.
- 这项研究提供了支持吸入三重疗法的证据,用于特定的COPD患者群体.
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