哮喘联盟

   摘要
   背景：吸入性糖皮质激素糠酸氟替卡松（FF）每天一次就很有效，是哮喘的一种治疗措施。哮喘和昼夜节律变化相关，因为夜间肺功能会更差。我们比较了早晨或晚间一天一次吸入糠酸氟替卡松（FF）治疗哮喘的效果。
   方法:患者持续性支气管哮喘的病人被纳入本项随机、重复剂量、双盲、双模拟、安慰剂对照、三因素交叉研究。在14天的磨合期后，患者接受了：早晨给药FF 100μg (AM)；或晚间给药FF 100μg (PM)；或安慰剂，采用ELLIPTA® 干粉吸入装置。患者均接受了这三种治疗，平均(14±2天)，相隔14-21天的洗脱期。主要终点是在每14天治疗结束时测定24小时加权平均1秒钟用力呼气量（FEV1）。
   结果：共28名患者参与了这项随机试验，年龄在19至67岁之间，其中21（75%）例完成所有三种研究。每日一次给药的FF 100μG导致24小时加权平均FEV1增加；早晨给药与晚间给药与安慰剂之间的差异不同，早晨给药增加了0.077L（90%可信区间为0.001，0.152），晚间给药增加了0.105L（90%可信区间为0.029，0.180），两者之间的校正差值为-0.028L（90%可信区间为-0.102，0.045）。早晨或晚间给药的不良反应的发生率相当（AES分别为18 / 23和18 / 24），无严重不良反应发生。
   结论：早晨和晚间每天一次给药FF 100μG相对于安慰剂而言，改善肺功能的效果相当。

 

（苏欣 审校）
Respir Med. 2016 Jan12.pii:S0954-6111(15)30102-5.doi:10.1016/j.rmed.2015.12.011. [Epub ahead of print]


 

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.
 

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.
 

Respir Med. 2016 Jan12.pii:S0954-6111(15)30102-5.doi:10.1016/j.rmed.2015.12.011. [Epub ahead of print]