在持续性哮喘患者中糠酸氟替卡松在早晨或傍晚的使用效果相同
2016/05/26
摘要
背景：吸入性糖皮质激素糠酸氟替卡松（FF）每天一次的使用对哮喘的治疗是有效的。哮喘与昼夜变化以及夜间肺功能恶化有关。我们比较了FF每天一次治疗哮喘在早晨或傍晚使用的疗效。
方法：我们将有持续性支气管哮喘的成人患者纳入了这个随机、重复剂量、双盲、双模拟、安慰剂对照、三向交叉研究。经过14天的磨合期，患者通过干粉吸入器ELLIPTA(®)接受：早上FF 100μg，晚上FF 100μg；或安慰剂。在14-21d的效应时区时间后，对患者进行所有的3组治疗（持续14±2d）。主要终点是在每14d治疗结束时测定24小时加权平均1秒钟用力呼气量（FEV1）。
结果：共有28名年龄在19至67岁之间的患者被随机分组，其中21人（75%）完成了所有三个研究组。每日一次FF 100μg给药导致24小时加权平均FEV1增加；
调整过的上午和晚上FF的剂量与安慰剂之间的差异分别为：0.077 L（90%可信区间[CI]：0.001，0.152）和0.105L（90%可信区间：0.029，0.180）（校正之后的平均差为：-0.028L[ 90% CI：-0.102，0.045 ]）。上午或者晚上服药不良事件的发生率相当（AEs；分别为18/23和18/24），无严重不良事件发生。
结论：上午和晚上每日一次的FF 100μg剂量相对于安慰剂来说，对改善肺功能的效果相当。
（苏欣 审校）
Respir Med. 2016 Mar;112:18-24. doi:10.1016/j.rmed.2015.12.011.Epub 2016 Jan 12.
The efficacy of fluticasone furoate administered in the morning or evening is comparable in patients with persistent asthma.
Kempsford RD1, Bal J2, Baines A3, Renaux J4, Ravindranath R5, Thomas PS6.
Author information
Abstract
BACKGROUND:The inhaled corticosteroid fluticasone furoate (FF) is efficacious as a once-daily treatment for the management of asthma. Asthma is associated with circadian changes, with worsening lung function at night. We compared the efficacy of once-daily FF in the morning or evening for the treatment of asthma.
METHODS:Adults with persistent bronchial asthma were enrolled into this randomised, repeat-dose, double-blind, double-dummy, placebo-controlled, three-way crossover study. After a 14-day run-in period, patients received either: FF 100 μg in the morning (AM); FF 100 μg in the evening (PM); or placebo, via the ELLIPTA(®) dry powder inhaler. Patients received all three treatments (14 ± 2 day duration) separated by a 14- to 21-day washout period. The primary endpoint was 24-h weighted mean forced expiratory volume in 1 s (FEV1) measured at the end of each 14-day treatment.
RESULTS:A total of 28 patients aged between 19 and 67 years were randomised and 21 (75%) completed all three study arms. Once-daily administration of FF 100 μg resulted in an increased 24-hour weighted mean FEV1; differences between the adjusted means for AM and PM FF dosing versus placebo were 0.077 L (90% confidence interval [CI]: 0.001, 0.152) and 0.105 L (90% CI: 0.029, 0.180), respectively (adjusted mean difference: -0.028 L [90% CI: -0.102, 0.045]). AM or PM doses had comparable incidences of adverse events (AEs; 18/23 versus 18/24, respectively), no serious AEs occurred.
CONCLUSION:AM and PM doses of once-daily FF 100 μg produced comparable improvements in lung function relative to placebo.
Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
KEYWORDS:Asthma; Efficacy; Evening dosing; Fluticasone furoate; Inhaled corticosteroid; Morning dosing
Respir Med. 2016 Mar;112:18-24. doi: 10.1016/j.rmed.2015.12.011. Epub 2016 Jan 12.
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