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NEJM:茚达特罗–格隆溴铵治疗COPD比沙美特罗–氟替卡松更有效

2016-05-16 崔倩 译 MedSci原创

大多数指南建议长效β受体激动剂(LABA)联合吸入糖皮质激素或长效毒蕈碱受体拮抗剂(LAMA)作为慢性阻塞性肺疾病(COPD)且具有高风险病情加重患者的首选治疗方法。LABA-LAMA治疗方案在这些患者中的作用尚不清楚。原始出处:Jadwiga A. Wedzicha,Donald Banerji,Kenneth R. Chapman,et al.Indacaterol–Glycopyrroniu

大多数指南建议长效β受体激动剂(LABA)联合吸入糖皮质激素或长效毒蕈碱受体拮抗剂(LAMA)作为慢性阻塞性肺疾病(COPD)且具有病情加重高风险患者的首选治疗方法。LABA-LAMA治疗方案在这些患者中的作用尚不清楚。

研究人员进行了一项52周的随机、双盲、双模拟、非劣效性试验。患有COPD并且在前一年至少有一次恶化病史的患者随机分配接受(通过吸入治疗)LABA茚达特罗(110μg)加上LAMA格隆溴铵(50μg),每日一次或LABA沙美特罗(50μg)加上吸入糖皮质激素(氟替卡松 500μg),每天两次。主要成果是所有COPD恶化的年增长率。

总共有1680例患者被分配到茚达特罗-格隆溴铵组,1682例患者分配到沙美特罗-氟替卡松组。茚达特罗-格隆溴铵不仅没有表现出劣效性,而且在对于减少所有COPD的年发生率方面还优于沙美特罗-氟替卡松;茚达特罗-格隆溴铵组的年发生率比沙美特罗-氟替卡松组低11%(3.59 vs 4.03;率比,0.89; 95%可信区间[CI],0.83至0.96; P=0.003)。茚达特罗-格隆溴铵组到第一次COPD恶化的时间比沙美特罗-氟替卡松组长(71天[95%CI,60至82] vs 51天[95%CI,46至57];风险比,0.84 [95%CI,0.78至0.91],表明降低了16%的风险; P<0.001)。茚达特罗-格隆溴铵组中度或重度加重的年发生率比沙美特罗-氟替卡松组低(0.98 vs 1.19;率比,0.83; 95%CI,0.75至0.91; P<0.001),且茚达特罗-格隆溴铵组到第一次中度或重度恶化的时间长于沙美特罗-氟替卡松组(风险比,0.78; 95%CI,0.70至0.86; P<0.001),作为到第一次严重恶化的时间(危险比,0.81; 95%CI,0.66至1.00; P=0.046)。茚达特罗-格隆溴铵 vs 沙美特罗-氟替卡松对慢性阻塞性肺病急性发作率的影响独立于基线血嗜酸性粒细胞计数。不良事件和死亡的发生率在两个组中相似。肺炎的发生率在茚达特罗-格隆溴铵组为3.2%,沙美特罗-氟替卡松组为4.8%(P=0.02)。

对于在前一年有病情加重史的患者,茚达特罗-格隆溴铵对于预防COPD加重比沙美特罗-氟替卡松更有效。

原始出处:

Jadwiga A. Wedzicha,Donald Banerji,Kenneth R. Chapman,et al.Indacaterol–Glycopyrronium versus Salmeterol–Fluticasone for COPD,NEJM,2016.5.15

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