哮喘联盟

   摘要
   目的：糠酸氟替卡松（FF：吸入性皮质类固醇激素）与维兰特罗(VI：长效β2受体激动剂)联用是哮喘和慢性阻塞性肺疾病治疗的每日一次疗法。本项为期12周的III期临床试验对每天一次FF/VI 100/25 mcg vs. FF 100 mcg (主要目标) 和 FF/VI 100/25 mcg vs. FF/VI 200/25 mcg (只进行描述性比较)治疗≥12岁中重度持续性哮喘的有效性和安全性进行了比较。
   方法：首要终点事件为12周时0-24小时的连续第1秒用力呼气容积（FEV1）的加权平均值（wm）。次要终点事件（基线后改变）是波谷FEV1和急救-缓解-24h的比例（%）、症状-缓解24h的比例（%），清晨和夜间峰值流速（PEF）。在整个过程中收集安全性数据（不良反应，AEs）。
   结果：与FF 100 mcg相比，FF/VI 100/25 mcg显著提高wmFEV1(p < 0.001)、波谷FEV1 (p = 0.014)、急救-缓解比例（p < 0.001）、24h症状-缓解比例（p = 0.002）、清晨和夜间PEF(p < 0.001)。与FF/VI 100/25 mcg 相比，FF/VI 200/25 mcg对所有的终点事件数值上略有提高。各组的AEs发生率相似。
   结论：与FF 100 mcg 相比，FF/VI 100/25 mcg显著提高所有的主要和次要终点事件。FF/VI 200/25 mcg vs. FF/VI 100/25 mcg数值上提高。所有的治疗耐受良好。

 

（苏欣 审校）
J Asthma. 2015 Dec;52(10):1073-83. doi: 10.3109/02770903.2015.1056350. Epub 2015 Aug 18.

 

Fluticasone furoate (FF)/vilanterol (100/25 mcg or 200/25 mcg) or FF (100 mcg) in persistent asthma.
 

Bernstein DI1, Bateman ED2, Woodcock A3, Toler WT4, Forth R5, Jacques L6, Nunn C6, O'Byrne PM7.
 

Abstract
OBJECTIVES:Fluticasone furoate (FF; inhaled corticosteroid) combined with vilanterol (VI; long-acting beta2 agonist) is a once-daily therapy for asthma and chronic obstructive pulmonary disease. This 12-week phase III study compared the efficacy and safety of once-daily (evening dosing) FF/VI 100/25 mcg versus FF 100 mcg (primary objective) and FF/VI 100/25 mcg versus FF/VI 200/25 mcg (descriptive comparison only) in patients (n = 1039) ≥12 years with moderate-to-severe persistent asthma.
METHODS:The primary end point was weighted mean (wm) 0-24-h serial forced expiratory volume in 1 s (FEV1) at week 12. Secondary end points (change from baseline) were trough FEV1 and the proportion (%) of rescue-free 24-h periods (both powered), the proportion (%) of symptom-free 24-h periods, and morning and evening peak expiratory flow (PEF). Safety data (adverse events, AEs) were collected throughout.
RESULTS:Compared with FF 100 mcg, FF/VI 100/25 mcg significantly improved wmFEV1 (p < 0.001), trough FEV1 (p = 0.014), % rescue-free (p < 0.001), % symptom-free (p = 0.002) 24-h periods, and morning and evening PEF (p < 0.001). FF/VI 200/25 mcg produced small numerical improvements versus FF/VI 100/25 mcg for all end points. Incidence of AEs was similar across groups.
CONCLUSIONS:FF/VI 100/25 mcg resulted in significant improvements in all primary and secondary end points versus FF 100 mcg. Numerical improvements occurred with FF/VI 200/25 mcg versus FF/VI 100/25 mcg. All treatments were well tolerated.
 

J Asthma. 2015 Dec;52(10):1073-83. doi: 10.3109/02770903.2015.1056350. Epub 2015 Aug 18.