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支气管扩张剂治疗与生物质烟雾相关的 COPD 患者过度充气:临床试验。

Bronchodilators for hyperinflation in COPD associated with biomass smoke: clinical trial.

机构信息

Department of Tobacco Smoking and COPD Research, Instituto Nacional de Enfermedades Respiratorias "Ismael Cosió Villegas", Mexico City, Mexico.

Department of Medical Attention, Instituto Nacional de Enfermedades Respiratorias "Ismael Cosió Villegas", Mexico City, Mexico.

出版信息

Int J Chron Obstruct Pulmon Dis. 2019 Aug 6;14:1753-1762. doi: 10.2147/COPD.S201314. eCollection 2019.

Abstract

INTRODUCTION

The efficacy of long-acting bronchodilators for COPD associated with biomass (BE-COPD) has not been properly evaluated.

OBJECTIVE

To determine the acute effect of indacaterol (IND) 150 μg q.d and tiotropium (TIO) 18 μg q.d. on lung hyperinflation, walking distance (WD) and dyspnea during the six-minute walking test (6MWT) in moderate BE-COPD at 30, 60 and 240 mins post-drug administration.

DESIGN

Randomized, controlled, open-level, crossover noninferiority clinical trial. Forty-two women with BE-COPD were randomly assigned to a bronchodilator sequence: IND-TIO or vice versa.

RESULTS

There were statistically significant changes over time in inspiratory capacity (IC) (<0.0001), FEV (<0.0001) and FVC (<0.0001) when IND was used. When TIO was administered, an increase over all time periods was observed only for FEV (<0.0001) and FVC (<0.0001), whereas for IC an increase was observed only at 30 mins and 24 hrs after TIO administration. We did not find clinically significant increases in WD and dyspnea after the administration of both bronchodilators.

CONCLUSION

Both IND and TIO showed significant and fast onset improvement in hyperinflation. Therefore, either of them may be recommended as a first line of treatment for COPD associated with BE-COPD.

摘要

简介

生物燃料引起的慢性阻塞性肺疾病(BE-COPD)患者的长效支气管扩张剂疗效尚未得到充分评估。

目的

确定 150μg 每日一次的茚达特罗(IND)和 18μg 每日一次的噻托溴铵(TIO)对 30、60 和 240 分钟后给药时中重度 BE-COPD 患者肺过度充气、步行距离(WD)和 6 分钟步行试验(6MWT)呼吸困难的急性影响。

设计

随机、对照、开放水平、交叉非劣效性临床试验。42 名 BE-COPD 女性患者被随机分配到支气管扩张剂序列:IND-TIO 或反之。

结果

当使用 IND 时,吸气量(IC)(<0.0001)、FEV(<0.0001)和 FVC(<0.0001)在时间上均有统计学意义的变化。当给予 TIO 时,所有时间点的 FEV(<0.0001)和 FVC(<0.0001)均观察到增加,而对于 IC,仅在 TIO 给药后 30 分钟和 24 小时观察到增加。我们没有发现两种支气管扩张剂给药后 WD 和呼吸困难有临床意义的增加。

结论

IND 和 TIO 均显示出快速起效和改善过度充气的作用。因此,两者均可作为治疗与 BE-COPD 相关的 COPD 的一线治疗药物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4a3/6689558/5d555ce12c9b/COPD-14-1753-g0001.jpg

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