在未经控制的喘中使用单个吸入器进行额外精细的三重治疗 (TRIMARAN和TRIGGER):两个双盲,并行组,随机的,受控的第三阶段试验
Johann Christian Virchow1, Piotr Kuna2, Pierluigi Paggiaro3
1Universitätsmedizin Rostock, Zentrum für Innere Medizin, Abteilung für Pneumologie, Rostock, Germany.
Lancet (London, England)
|October 5, 2019
概括
单次吸入剂的三重治疗,包括贝克罗梅他松二酸盐 (BDP),形式醇烟酸 (FF) 和糖皮龙 (G),改善了肺功能,并减少了非控制性喘患者的恶化. 这种组合疗法为治疗严重的呼吸系统疾病提供了新的选择.
科学领域:
- 呼吸系统医学
- 临床试验
- 药理学
背景情况:
- 没有先前的研究评估了单吸入器三重治疗喘.
- 这项研究解决了额外精细贝克洛马二酸盐 (BDP),形式醇烟酸 (FF) 和甘 (G) 联合治疗的疗效差距.
- 这项研究研究了将长效肌抗剂 (LAMA) 添加到吸入性皮质类固醇 (ICS) 和长效β2抗剂 (LABA) 治疗的益处.
研究的目的:
- 评估单次吸入器三重疗法 (BDP/ FF/ G) 与双重疗法 (BDP/ FF) 在未控制喘的成年人中的疗效.
- 评估肺功能 (FEV1) 的改善和恶化率的降低.
- 确定三重治疗方案的安全性.
主要方法:
- 在多个国际地点进行了两项并行组,双盲,随机,主控的3期试验 (TRIMARAN和TRIGGER).
- 在此之前接受ICS/ LABA治疗的非控制性喘患者接受了BDP/ FF/ G或BDP/ FF治疗52周.
- 主要终点包括26周的剂前FEV1和52周的中度至重度恶化率.
主要成果:
- 与BDP/ FF相比,单次吸入器三重治疗 (BDP/ FF/ G) 在两个试验中显著改善了剂前FEV1 (TRIMARAN: +57毫升,TRIGGER: +73毫升).
- 在TRIMARAN中,BDP/ FF/ G的中度至重度恶化减少了15% (p=0. 033),而TRIGGER则减少了12% (p=0. 11).
- 安全性概况相似,与治疗相关的严重不良事件发生率低,与治疗相关的死亡没有.
结论:
- 单次吸入器三重疗法 (BDP/FF/G) 有效改善非控制性喘的成年人的肺功能.
- 在BDP/ FF治疗中添加糖表明恶化率下降的趋势.
- 对于需要加强喘控制的患者来说,这种三重治疗是一种安全有效的治疗选择.
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