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糠酸氟替卡松/维兰特罗与丙酸氟替卡松治疗哮喘合并运动诱发性支气管收缩患者的疗效比较

Fluticasone furoate/vilanterol versus fluticasone propionate in patients with asthma and exercise-induced bronchoconstriction.

作者信息

Martin Neil, Weiler John M, Pearlman David, Jacques Loretta, Nunn Carol, Forth Richard, West Sarah, Dunn Karen, O'Byrne Paul M

机构信息

Glenfield Hospital, University Hospitals of Leicester, Leicester, UK.

GSK, London, UK.

出版信息

J Asthma. 2020 Apr;57(4):431-440. doi: 10.1080/02770903.2019.1579344. Epub 2019 Feb 22.

Abstract

: To investigate whether once-daily (OD) fluticasone furoate (FF)/vilanterol (VI) provides greater long-term protection from postexercise fall in forced expiratory volume in 1 s (FEV) than twice-daily (BD) fluticasone propionate (FP) in patients with asthma and exercise-induced bronchoconstriction. : A randomized, double-blind, crossover study was conducted in patients (aged 12-50 years) on low-/mid-dose maintenance inhaled corticosteroid. Following a 4-week run-in period (FP 250 µg BD), patients with a ≥ 20% decrease in postexercise FEV received FF/VI 100/25 µg OD or FP 250 µg BD for 2 weeks. Exercise challenges were carried out 23 h after the first dose of study medication, and 12 and 23 h after evening clinic dose at the end of the 2-week treatment period. After a 2-week washout period (FP 250 µg), patients crossed over treatments, with procedures and tests repeated. The primary endpoint was mean maximal percentage decrease from pre-exercise FEV following exercise challenge 12-h postevening dose on Day 14. The mean maximal percentage decrease from pre-exercise FEV after the 12-h exercise challenge (Day 14) was 15.02% with FF/VI, and 16.71% with FP (difference, -1.69; 95% confidence interval, -3.76 to 0.39; 0.109). After the 23-h exercise challenge (Day 14), respective mean maximal decreases were 11.90% and 14.05% (difference, -2.15; 95% confidence interval, -4.31 to 0.01). The study failed to show a difference between FF/VI and FP at providing long-term protection from exercise-induced bronchoconstriction.

摘要

目的

探讨对于患有哮喘和运动诱发性支气管收缩的患者,每日一次(OD)糠酸氟替卡松(FF)/维兰特罗(VI)在预防运动后1秒用力呼气量(FEV)下降方面是否比每日两次(BD)丙酸氟替卡松(FP)提供更持久的保护作用。

方法

对年龄在12至50岁、正在使用低/中剂量维持吸入性糖皮质激素的患者进行了一项随机、双盲、交叉研究。在为期4周的导入期(BD使用FP 250 μg)后,运动后FEV下降≥20%的患者接受FF/VI 100/25 μg OD或FP 250 μg BD治疗2周。在首次服用研究药物后23小时、以及在为期2周的治疗期结束时晚间门诊服药后12小时和23小时进行运动激发试验。经过为期2周的洗脱期(FP 250 μg)后,患者交叉接受治疗,并重复进行相关程序和检测。主要终点是在第14天晚间服药后12小时运动激发试验后,相对于运动前FEV的平均最大下降百分比。在第14天进行12小时运动激发试验后,FF/VI组相对于运动前FEV的平均最大下降百分比为15.02%,FP组为16.71%(差值为 -1.69;95%置信区间为 -3.76至0.39;P = 0.109)。在第14天进行23小时运动激发试验后,各自的平均最大下降百分比分别为11.90%和14.05%(差值为 -2.15;95%置信区间为 -4.31至0.01)。该研究未能显示出FF/VI和FP在预防运动诱发性支气管收缩的长期保护作用方面存在差异。

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