Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial
Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial
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DOI：
10.1016/s0140-6736(03)12459-2
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发表时间：
2003-02-08
期刊：
影响因子：
168.9
通讯作者：
Maden, C
中科院分区：
文献类型：
--
作者：
Calverley, P;Pauwels, R;Maden, C
吸入长效β 2受体激动剂可改善症状性慢性阻塞性肺疾病（COPD）患者的肺功能和健康状况，而吸入皮质类固醇可降低症状急性加重发作的频率并延缓健康状况恶化。我们假设，这些治疗的组合将优于单独使用的每个组件。方法1465例COPD患者从25个国家的门诊部招募。他们在一项随机、双盲、平行组、安慰剂对照研究中接受了12个月的治疗，分别为50 μ g沙美特罗每日两次（n= 372）、500 μ g氟替卡松每日两次（n=374）、50 μ g沙美特罗和500 μ g氟替卡松每日两次（n=358）或安慰剂（n=361）。主要结局是治疗12个月后以及患者停用所有支气管扩张剂至少6小时和停用研究药物至少12小时后的治疗前1秒用力呼气量（FEV 1）。次要结局是其他肺功能测量、症状和补救治疗使用、急性加重次数、患者退出和疾病特异性健康状况。我们评估了不良事件、血清皮质醇浓度、皮肤瘀伤和心电图。分析是预定义的研究protocol.Findings所有积极的治疗改善肺功能，症状和健康状况，减少使用急救药物和恶化的频率。与安慰剂相比，联合治疗显著改善了治疗前FEV 1（治疗差异133 mL，95% CI 105-161，p
Background Inhaled longacting beta(2) agonists improve lung function and health status in symptomatic chronic obstructive pulmonary disease (COPD), whereas inhaled corticosteroids reduce the frequency of acute episodes of symptom exacerbation and delay deterioration in health status. We postulated that a combination of these treatments would be better than each component used alone.Methods 1465 patients with COPD were recruited from outpatient departments in 25 countries. They were treated in a randomised, double-blind, parallel-group, placebo-controlled study with either 50 mug salmeterol twice daily (n=372), 500 mug fluticasone twice daily (n=374), 50 mug salmeterol and 500 mug fluticasone twice daily (n=358), or placebo (n=361) for 12 months. The primary outcome was the pretreatment forced expiratory volume in 1 s (FEV1) after 12 months treatment' and after patients had abstained from all bronchodilators for at least 6 h and from study medication for at least 12 h. Secondary outcomes were other lung function measurements, symptoms and rescue treatment use, the number of exacerbations, patient withdrawals, and disease-specific health status. We assessed adverse events, serum cortisol concentrations, skin bruising, and electrocardiograms. Analysis was as predefined in the study protocol.Findings All active treatments improved lung function, symptoms, and health status and reduced use of rescue medication and frequency of exacerbations. Combination therapy improved pretreatment FEV1 significantly more than did placebo (treatment difference 133 mL, 95% CI 105-161, p