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福莫特罗和噻托溴铵在中重度慢性阻塞性肺疾病患者中的起效时间和作用持续时间。

Onset and duration of action of formoterol and tiotropium in patients with moderate to severe COPD.

作者信息

Richter Kai, Stenglein Stephan, Mücke Marion, Sieder Christian, Schmidtmann Sören, Harnest Ulf, Weidinger Gottfried, Magnussen Helgo

机构信息

Pulmonary Research Institute, Grosshansdorf, Germany.

出版信息

Respiration. 2006;73(4):414-9. doi: 10.1159/000091996. Epub 2006 Mar 9.

Abstract

BACKGROUND

Chronic obstructive pulmonary disease (COPD) management guidelines recommend regular treatment with one or more long-acting bronchodilators for patients with moderate to severe COPD.

OBJECTIVE

To compare the onset and duration of action of formoterol and tiotropium in patients with COPD.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

摘要

背景

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。

目的

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。

方法

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。

结果

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。

结论

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。

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