哮喘联盟

    背景：茚达特罗是一种新型的每日1次的吸入性β₂--受体激动剂，作为与吸入性糖皮质激素固定剂量组合的一个组成部分用于临床治疗哮喘。
    目的：评估茚达特罗治疗慢性持续性哮喘的有效性和安全性。
    方法：共有115名患者入选本研究，采用随机双盲、不完全区组的交叉设计，一共4个7天治疗周期(相隔7天的冲洗期)，通过单一剂量干粉吸入器吸入100，200，300，400或600mg茚达特罗或安慰剂，每天1次。在第4个冲洗期后，患者服用1天的福莫特罗12mu g，每天2次。用药24小时后的第1和第7天测定1秒钟用力呼气容积(FEV1)。
    结果：标准化(对应于时间)FEV1曲线下面积在(AUC22-24h)第1天的22至24小时，≥200mg的茚达特罗均优于安慰剂(P<0.05)，效果类似或优于福莫特罗12mg，每天2次。到第7天，100，200，300，400或600mg茚达特罗与安慰剂的FEV1标准面积22-24平均差异分别为0.08，0.16，0.15，0.11和0.16 L(与安慰剂相比均P<0.05)。第7天≥200mg的茚达特罗的平均FEV1高于安慰剂服药前和所有服药后的时间点。不良事件一般较轻微，没有发生严重不良事件，与其他安全的疗法之间没有任何临床差异。
    结论：每日一次的茚达特罗具有持续24小时的支气管扩张功效，服药第1天和第7天具有相似的疗效，并且耐受性良好。

（林江涛 审校）
Kanniess F, et al. J Asthma. 2008 Dec;45(10):887-892.

Efficacy and Safety of Indacaterol, a New 24-hour beta (2)-Agonist, in Patients with Asthma: A Dose-Ranging Study.

Kanniess F, Boulet LP, Pierzchala W, Cameron R, Owen R, Higgins M.
Pulmonary Research Institute, Hospital Grosshansdorf, Grosshansdorf, Germany.

Background: Indacaterol is a new once-daily inhaled beta(2)-agonist in clinical development for asthma as a component of a fixed-dose combination with an inhaled corticosteroid.
Objectives: To investigate the efficacy and safety of indacaterol in patients with chronic persistent asthma.
Methods: A total of 115 patients were randomized in a double-blind, incomplete-block cross-over design to sequences of four 7-day treatment periods (separated by 7-day washouts) with indacaterol 100, 200, 300, 400, or 600 mu g or placebo, once daily, via single-dose dry-powder inhaler. After the fourth washout, patients received 1 day of open-label formoterol 12 mu g twice daily. Forced expiratory volume in 1 second (FEV(1)) was measured for 24 hours post-dose on days 1 and 7.
Results: For standardized (with respect to time) FEV(1) area under the curve at 22 to 24 hours (AUC(22-24h)) on day 1, indacaterol doses >/=200 mu g were superior to placebo (p < 0.05) and similar or greater than formoterol 12 mug twice daily. By day 7, mean differences from placebo in FEV(1) standardized AUC(22-24h) were 0.08, 0.16, 0.15, 0.11, and 0.16 L for indacaterol 100, 200, 300, 400, and 600 mug, respectively (all p < 0.05 vs. placebo). Mean FEV(1) for indacaterol doses >/= 200 mug on day 7 was higher than placebo (p < 0.05) pre-dose and at all post-dose time points. AEs were generally mild in severity; no serious AEs occurred. No clinically meaningful differences were observed between treatments in any safety assessments.
Conclusions: Once-daily indacaterol demonstrated sustained 24-hour bronchodilator efficacy, with similar efficacy on days 1 and 7, and was generally well tolerated.