测量与感知到的支气管扩张情况。一项在中度持续性哮喘患者中比较福莫特罗和沙美特罗的安慰剂对照交叉试验。

Profiles of measured and perceived bronchodilation. A placebo-controlled cross-over trial comparing formoterol and salmeterol in moderate persistent asthma.

作者信息

Schermer T R J, Hoff W J, Greefhorst A P M, Creemers J P H M, Sips A P, Westbroek J, van Herwaarden C L A

机构信息

Department of General Practice-229/HAG, University Medical Centre Nijmegen, P O Box 9101, 6500 HB Nijmegen, The Netherlands.

出版信息

Pulm Pharmacol Ther. 2004;17(4):205-12. doi: 10.1016/j.pupt.2004.03.003.

DOI:10.1016/j.pupt.2004.03.003

PMID:15219265

Abstract

BACKGROUND AND OBJECTIVE

Long-acting beta(2)-agonists have acquired an indispensable position in the management of bronchial symptoms in patients with asthma. The objective of this study was to compare onset-of-action and clinical effectiveness of formoterol and salmeterol during 2 weeks of treatment. We also investigated the association between bronchodilator effects and perceived relieve of dyspnoea.

METHODS

A multi-centre randomized double-blind placebo-controlled cross-over trial was performed in 35 subjects with moderate persistent asthma. Treatment periods existed of 2 weeks formoterol (12 microg bid), salmeterol (50 microg bid) and placebo, all administered by pressurized metered dose inhaler. FEV(1) and Visual Analogue Scale (VAS) scores were repeatedly measured until 180 min post-bronchodilation (post-BD), before as well as after each treatment period. Onset-of-action was defined as a >/=15% increase in FEV(1). Subjects kept diaries of morning and evening PEFR values and use of rescue bronchodilator.

RESULTS

Formoterol and salmeterol both caused a significant increase in FEV(1) (0.45L [95% CI 0.01, 0.80] and 0.27L [95% CI 0.08, 0.62] respectively). At 3' post-BD, three times as many subjects demonstrated onset-of-action on formoterol compared to salmeterol (36% versus 13%, P = 0.063), at 6' post-BD 42% versus 27% (P = 0.063). VAS scores were similar for formoterol and salmeterol at pre-treatment assessment, but tended to be higher for formoterol after 2weeks treatment. No differences between formoterol and salmeterol were observed for PEFR values or use of rescue medication. 50% of the subjects preferred formoterol, 29% salmeterol (P < 0.001). Significant associations between FEV(1) and VAS ratings existed only at 10', 15' and 30' post-BD, not before or after these time points.

CONCLUSION

The earlier described faster onset-of-action of formoterol as compared to a equipotent dosage of salmeterol was confirmed in this study. Perception of decreasing airflow obstruction may be delayed after acute bronchodilation.

摘要

背景与目的

长效β₂受体激动剂在哮喘患者支气管症状的管理中已占据不可或缺的地位。本研究的目的是比较福莫特罗和沙美特罗在2周治疗期间的起效时间和临床疗效。我们还研究了支气管扩张剂效果与呼吸困难缓解感之间的关联。

方法

对35例中度持续性哮喘患者进行了一项多中心随机双盲安慰剂对照交叉试验。治疗期包括2周的福莫特罗（12微克，每日两次）、沙美特罗（50微克，每日两次）和安慰剂治疗，均通过压力定量吸入器给药。在每次治疗期前后，反复测量FEV₁和视觉模拟评分（VAS），直至支气管扩张后180分钟。起效定义为FEV₁增加≥15%。受试者记录早晚的呼气峰流速（PEFR）值以及急救支气管扩张剂的使用情况。

结果

福莫特罗和沙美特罗均使FEV₁显著增加（分别为0.45升[95%可信区间0.01, 0.80]和0.27升[95%可信区间0.08, 0.62]）。在支气管扩张后3分钟，与沙美特罗相比，使用福莫特罗出现起效的受试者数量是其3倍（36%对13%，P = 0.063），在支气管扩张后6分钟为42%对27%（P = 0.063）。在治疗前评估时，福莫特罗和沙美特罗的VAS评分相似，但在治疗2周后，福莫特罗的评分往往更高。在PEFR值或急救药物使用方面，未观察到福莫特罗和沙美特罗之间的差异。50%的受试者更喜欢福莫特罗，29%更喜欢沙美特罗（P < 0.001）。FEV₁与VAS评分之间的显著关联仅在支气管扩张后10分钟、15分钟和30分钟存在，在这些时间点之前或之后均不存在。