哮喘联盟

   摘要
   背景：人们正在研发吸入糖皮质激素糠酸氟替卡松（FF）联合长效β2受体激动剂维兰特罗(VI)，用于治疗哮喘和慢性阻塞性肺病。
   目的：比较糠酸氟替卡松联合维兰特罗（FF-VI）与单用糠酸氟替卡松（FF）治疗持续性哮喘患者（≥12岁）的有效性和安全性。
   方法：在一项随机、双盲、对照研究中，609例患者分别接受FF-VI 100-25 mcg、FF 100 mcg或安慰剂治疗12周，每日一次（夜间），以干粉吸入的形式。主要研究终点是与基线比较，FEV1谷值的改变和连续加权平均FEV1(wmFEV1)的改变。并评估了24小时无急救用药天数和安全性。
   结果：与基线比较，安慰剂组的FEV1谷值增加了196ml，wmFEV1增加了212ml。与安慰剂组相比，FF-VI组和FF组的FEV1谷值显著增加，分别增加了172ml（P<0.001）和136ml（P = 0.002）。与安慰剂组相比，FF-VI组和FF组的连续wmFEV1也显著增加，分别增加了302ml（P<0.001）和186ml（P = 0.003）。FF-VI组和FF组的连续wmFEV1接近于有显著差异（P = 0.060），FF-VI组比FF组增加了116 mL；两组间的FEV1谷值无显著差异，FF-VI组比FF组增加了36ml（P = 0.405）。FF-VI组24小时无急救用药天数比例比FF组高10.6%，比安慰剂组高19.3%。与安慰剂组相比，FF-VI 组具有显著的尿糖皮质激素抑制（P = 0.032），而FF组则无。各组间的不良反应和安全性相似。
   结论：与安慰剂组相比，FF-VI 和FF组持续性哮喘患者的肺功能有了显著改善。与单用FF相比，FF和VI的联用所增加的FEV1没有统计学意义。夜间FEV1谷值的高安慰剂反应可能会影响有效性的评价。
 

（苏欣 审校）
JAllergyClinImmunolPract.2014Sep-Oct;2(5):553-61.doi:10.1016/j.jaip.2014.02.010. Epub 2014 Apr 24.

 

Fluticasone Furoate-Vilanterol 100-25 mcg Compared with Fluticasone Furoate 100 mcg in Asthma: A Randomized Trial.
 

Bleecker ER1, Lötvall J2, O'Byrne PM3, Woodcock A4, Busse WW5, Kerwin EM6, Forth R7, Medley HV8, Nunn C8, Jacques L8, Bateman ED9.
 

ABSTRACT
BACKGROUND: The inhaled corticosteroid fluticasone furoate (FF) in combination with the long-acting β2-agonist vilanterol (VI) is under development for the treatment of asthma and chronic obstructive pulmonary disease.
OBJECTIVE: To compare the efficacy and safety of FF-VI and FF in patients (≥12 years old) with persistent asthma.
METHODS: In a randomized, double-blind, parallel-group study, patients (n = 609) (intent-to-treat population) received FF-VI 100-25 mcg, FF 100 mcg, or placebo once daily (evening) by using a dry powder inhaler for 12 weeks. Coprimary end points were change from baseline in trough FEV1 and serial (0-24 hours) weighted mean FEV1 (wmFEV1). Rescue-free 24-hour periods and safety also were assessed.
RESULTS: Placebo increased trough FEV1 (196 mL) and wmFEV1 (212 mL) versus baseline. Compared with placebo, FF-VI and FF significantly improved trough FEV1 (172 mL [P < .001] and 136 mL [P = .002]), respectively, and serial wmFEV1 (302 mL [P < .001] and 186 mL [P = .003]), respectively. Treatment differences between FF-VI and FF approached significance for serial wmFEV1 (116 mL; P = .060) but not for trough FEV1 (36 mL; P = .405). The percentage of rescue-free 24-hour periods with FF-VI was 10.6% greater than FF and 19.3% greater than placebo. Statistically significant (P = .032) urinary cortisol suppression was observed with FF-VI (ratio, 0.82) relative to placebo, but not with FF. Adverse event and safety profiles were similar across treatment groups.
CONCLUSIONS: Significant improvement in lung function was observed with FF-VI and FF versus placebo in patients with persistent asthma. Improvement of FEV1 when VI was added to FF was not significant. The high placebo response in evening trough FEV1 may have influenced the assessment of efficacy.
 

JAllergyClinImmunolPract.2014Sep-Oct;2(5):553-61.doi:10.1016/j.jaip.2014.02.010. Epub 2014 Apr 24.