哮喘联盟

   摘要
   背景：糠酸氟替卡松（FF），一个全新的吸入性皮质类固醇激素（ICS）和维兰特罗（VI），一个长效β2受体激动剂，两者组合制剂一日一次治疗哮喘和慢性阻塞性肺病尚在研发中。本研究旨在比较FF/VI和丙酸氟替卡松（FP）/沙美特罗（SAL）在中等剂量ICS下仍未控制的持续性哮喘患者中的疗效。
   方法：在一项随机、双盲、双模拟、平行组研究中，806例患者接受FF/VI (100/25 μg, n = 403)治疗，1天1次，晚上通过干粉吸入器给药，或者接受FP/SAL (250/50 μg, n = 403)，1天2次，通过Diskus™/Accuhaler™给药。主要疗效指标是治疗24周后，第一秒用力呼气量的0-24h连续加权平均值(wmFEV1)。
   结果：FF/VI (341 ml) 和FP/SAL (377 ml)治疗组均可观察到0-24h wmFEV1相比基线水平有改善，治疗期间校正平均差值无统计学意义(-37 ml [95% 可信区间: -88, 15], p = 0.162)。两组0-4h连续wmFEV1，FEV1低值、哮喘控制和生活质量问卷评分无差别。治疗组之间报告的发作次数无差别。两组耐受性均良好，对尿皮质醇排泄或生命体征无临床相关影响，无治疗相关严重不良反应。
   结论：在改善持续性哮喘患者肺功能方面，FF/VI一天一次的疗效与FP/SAL相似。未发现安全性事件。
 

（苏楠 审校）
Chest. 2013 Jul 11. doi: 10.1378/chest.13-0178. [Epub ahead of print]
 

Efficacy and Safety of Fluticasone Furoate/Vilanterol Compared with Fluticasone Propionate/Salmeterol Combination in Adult and Adolescent Patients with Persistent Asthma: a Randomized Trial.
 

Woodcock A, Bleecker ER, Lötvall J, O'Byrne PM, Bateman ED, Medley H, Ellsworth A, Jacques L, Busse WW.
 

Abstract
BACKGROUND: The combination of fluticasone furoate (FF), a novel inhaled corticosteroid (ICS) and vilanterol (VI), a long-acting beta2 agonist, is under development as a once-daily treatment for asthma and chronic obstructive pulmonary disease. The aim of this study was to compare the efficacy of FF/VI with fluticasone propionate (FP)/salmeterol (SAL) in patients with persistent asthma uncontrolled on medium-dose ICS.
METHODS: In a randomized, double-blind, double-dummy, parallel-group study, 806 patients received FF/VI (100/25 μg, n = 403) once daily in the evening via dry powder inhaler, or FP/SAL (250/50 μg, n = 403) twice daily via Diskus™/Accuhaler™. The primary efficacy measure was 0-24 h serial weighted mean forced expiratory volume in 1 second (wmFEV1) after 24 weeks of treatment.
RESULTS: Improvements from baseline in 0-24 h wmFEV1 were observed with both FF/VI (341 ml) and FP/SAL (377 ml); the adjusted mean treatment difference was not statistically significant (-37 ml [95% confidence interval: -88, 15], p = 0.162). There were no differences between the 0-4 h serial wmFEV1, trough FEV1, and asthma control and quality of life questionnaire scores. There was no difference in reported exacerbations between treatments. Both treatments were well tolerated, with no clinically relevant effect on urinary cortisol excretion or vital signs, and no treatment-related serious adverse events.
CONCLUSIONS: The efficacy of once-daily FF/VI was similar to twice-daily FP/SAL in improving lung function in patients with persistent asthma. No safety issues were identified.
 

Chest. 2013 Jul 11. doi: 10.1378/chest.13-0178. [Epub ahead of print]