Richter Kai, Stenglein Stephan, Mücke Marion, Sieder Christian, Schmidtmann Sören, Harnest Ulf, Weidinger Gottfried, Magnussen Helgo
Pulmonary Research Institute, Grosshansdorf, Germany.
Respiration. 2006;73(4):414-9. doi: 10.1159/000091996. Epub 2006 Mar 9.
Chronic obstructive pulmonary disease (COPD) management guidelines recommend regular treatment with one or more long-acting bronchodilators for patients with moderate to severe COPD.
To compare the onset and duration of action of formoterol and tiotropium in patients with COPD.
This randomized, multicentre, open-label crossover study in 38 patients with COPD (mean age 64 years; mean FEV(1) 55% predicted) assessed the effect of 7 days of treatment with formoterol (12 microg b.i.d. via Foradil Aerolizer) vs. tiotropium (18 microg o.d. via Spiriva HandiHaler) on lung function measured over a period of 12 h after the first dose on day 1 and the last dose on day 8.
The primary efficacy variable, FEV(1)-AUC during the first 2 h post-dose (FEV(1)-AUC(10-120 min)), was significantly higher for formoterol compared with tiotropium, with between-treatment differences of 124 ml (p = 0.016) after the first dose and 80 ml (p = 0.036) after 7 days' treatment in favour of formoterol. FEV(1) measured 12 h after inhalation did not differ statistically significantly between treatments. Adverse events occurred in 2 (5%) patients after treatment with formoterol and in 5 (12%) patients after treatment with tiotropium.
This study demonstrates faster onset of action and greater bronchodilation of formoterol vs. tiotropium for bronchodilation within the first 2 h of inhalation (FEV(1)-AUC(10-120 min)) and comparable bronchodilation 12 h post-inhalation in patients with moderate to severe COPD.
慢性阻塞性肺疾病(COPD)管理指南建议,中重度COPD患者应使用一种或多种长效支气管扩张剂进行规律治疗。
比较福莫特罗和噻托溴铵在COPD患者中的起效时间和作用持续时间。
这项随机、多中心、开放标签的交叉研究纳入了38例COPD患者(平均年龄64岁;平均FEV₁为预测值的55%),评估了福莫特罗(通过奥克斯都保每日2次,每次12μg)与噻托溴铵(通过思力华能倍乐每日1次,每次18μg)治疗7天对第1天首次给药后和第8天最后一剂给药后12小时内肺功能的影响。
主要疗效变量,即给药后前2小时的FEV₁ - AUC(FEV₁ - AUC₁₀ - ₁₂₀min),福莫特罗显著高于噻托溴铵,首次给药后治疗组间差异为124ml(p = 0.016),7天治疗后差异为80ml(p = 0.036),均有利于福莫特罗。吸入后12小时测量的FEV₁在治疗组间无统计学显著差异。福莫特罗治疗后有2例(5%)患者发生不良事件,噻托溴铵治疗后有5例(12%)患者发生不良事件。
本研究表明,对于中重度COPD患者,福莫特罗在吸入后前2小时(FEV₁ - AUC₁₀ - ₁₂₀min)的起效更快,支气管扩张作用更强,且吸入后12小时的支气管扩张效果相当。