稳定期慢性阻塞性肺疾病患者雾化吸入左沙丁胺醇的评估

An evaluation of nebulized levalbuterol in stable COPD.

作者信息

Datta Debapriya, Vitale Anthony, Lahiri Bimalin, ZuWallack Richard

机构信息

Section of Pulmonary and Critical Care Medicine, St. Francis Hospital & Medical Center, 114 Woodland Street, Hartford, CT 06105, USA.

出版信息

Chest. 2003 Sep;124(3):844-9.

PMID:12970007

Abstract

BACKGROUND

Levalbuterol, the R-isomer of albuterol, has advantages over racemic albuterol in asthma; however, the effectiveness of this beta-agonist in COPD has received little attention.

OBJECTIVES

To evaluate the effectiveness of a single dose of nebulized levalbuterol in COPD.

DESIGN

A randomized, double-blind, placebo-controlled trial comparing nebulized levalbuterol to racemic albuterol, combined racemic albuterol and ipratropium, and placebo.

PATIENTS

Thirty patients with stable COPD (FEV(1) between 45% and 70% of predicted) were studied.

METHODS

After withholding usual bronchodilator medications for appropriate washout periods, patients were randomized on separate visits to receive single doses of each the following nebulized bronchodilator medications: (1) levalbuterol, 1.25 mg; (2) racemic albuterol, 2.5 mg; (3) combined racemic albuterol, 2.5 mg, and ipratropium, 0.5 mg; or (4) placebo. FEV(1), FVC, pulse rate, and oxygen saturation were measured at baseline, 0.5 h following nebulization, and hourly for 6 h. Hand tremor, using a 7-point scale, was measured at baseline, 0.5 h, 1 h, and 2 h. Treatment-placebo differences were analyzed using repeated-measures analysis of variance and least-squares means.

RESULTS

The mean age (+/- SD) of patients was 69 +/- 15 years. Mean FEV(1) was 1.15 +/- 0.49 L. By 0.5 h following study drug administration, all three nebulized bronchodilator treatments led to similar, significant improvements in FEV(1) compared to placebo. These effects persisted at 1 h and 2 h for all three treatments; however, by 3 h, only the combined albuterol/ipratropium group had a mean change in FEV(1) significantly greater than placebo. There were no significant differences between bronchodilator groups at any time period. A mild increase in pulse rate was observed in all treatment groups. There were no significant treatment-placebo differences in oxygen saturation or hand tremor.

CONCLUSION

For single-dose, as-needed use in COPD, there appears to be no advantage in using levalbuterol over conventional nebulized bronchodilators.

摘要

背景

沙丁胺醇的R-异构体左旋沙丁胺醇在哮喘治疗中比消旋沙丁胺醇更具优势；然而，这种β受体激动剂在慢性阻塞性肺疾病（COPD）中的有效性鲜受关注。

目的

评估单剂量雾化吸入左旋沙丁胺醇治疗COPD的有效性。

设计

一项随机、双盲、安慰剂对照试验，比较雾化吸入左旋沙丁胺醇与消旋沙丁胺醇、消旋沙丁胺醇与异丙托溴铵联合用药以及安慰剂的效果。

患者

研究了30例稳定期COPD患者（第一秒用力呼气容积[FEV₁]为预测值的45%至70%）。

方法

在适当的洗脱期停用常规支气管扩张剂后，患者在不同时间就诊时被随机分组，接受以下单剂量雾化支气管扩张剂治疗：（1）左旋沙丁胺醇，1.25毫克；（2）消旋沙丁胺醇，2.5毫克；（3）消旋沙丁胺醇2.5毫克与异丙托溴铵0.5毫克联合用药；或（4）安慰剂。在基线、雾化后0.5小时以及之后每小时测量6小时的FEV₁、用力肺活量（FVC）、脉搏率和血氧饱和度。使用7分制在基线、0.5小时、1小时和2小时测量手部震颤。采用重复测量方差分析和最小二乘均值分析治疗组与安慰剂组的差异。

结果

患者的平均年龄（±标准差）为69±15岁。平均FEV₁为1.15±0.49升。在给予研究药物后0.5小时，与安慰剂相比，所有三种雾化支气管扩张剂治疗均使FEV₁有相似且显著的改善。所有三种治疗在1小时和2小时时这些效果持续存在；然而，到3小时时，只有沙丁胺醇/异丙托溴铵联合用药组的FEV₁平均变化显著大于安慰剂组。在任何时间段支气管扩张剂组之间均无显著差异。所有治疗组均观察到脉搏率轻度升高。在血氧饱和度或手部震颤方面治疗组与安慰剂组无显著差异。