BRONCHODILATORY RESPONSES TO FORMOTEROL, IPRATROPIUM, AND THEIR COMBINATION IN PATIENTS WITH STABLE COPD
BRONCHODILATORY RESPONSES TO FORMOTEROL, IPRATROPIUM, AND THEIR COMBINATION IN PATIENTS WITH STABLE COPD
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稳定期 COPD 患者对福莫特罗、异丙托品及其组合的支气管扩张反应
DOI：
10.1111/j.1742-1241.1999.tb11699.x
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发表时间：
1999
影响因子：
2.6
通讯作者：
A. Antoniades
中科院分区：
文献类型：
--
作者：
L. Sichletidis;J. Kottakis;S. Marcou;T. Constantinidis;A. Antoniades
我们在一项随机、单盲、患者内、安慰剂对照的临床研究中研究了27例稳定的慢性阻塞性肺病（COPD）患者。每名患者在6个不同的日子被随机分配接受以下药物方案之一：40 μg异丙托溴铵（爱全乐MDI，20 μg/喷）加2喷安慰剂; B. 12 μg富马酸福莫特罗（Foradil MDI，12 μg/喷）加3喷安慰剂; C.异丙托溴铵80 μg; D. 24 μg福莫特罗加2喷安慰剂; E. 12 μg福莫特罗+40 μg异丙托溴铵+1喷安慰剂; F. 4揿安慰剂。在每个研究日，在研究药物给药后5、10、15和60分钟以及此后每小时测量肺量指数和生命体征，直至并包括12小时。异丙托溴铵和福莫特罗联合给药（335.2 ml，SE 24.6）的平均峰值FEV 1变化（主要终点）最大，与两种试验剂量异丙托溴铵单次给药后观察到的峰值变化显著不同（分别为p<0.05和p<0.05）。整个研究期间的安全性和耐受性均令人满意。
We studied 27 patients with stable chronic obstuctive pulmonary disease (COPD) in a randomised, single‐blind, within‐patient, placebo‐controlled clinical study. Each patient was assigned on six separate days to receive one of the following drug regimens in random order: A. 40 μg ipratropium bromide (Atrovent MDI, 20 μg/puff) plus 2 puffs placebo; B. 12 μg formoterol fumarate (Foradil MDI,12 μg/puff) plus 3 puffs placebo; C. 80 μg ipratropium; D. 24 μg formoterol plus 2 puffs placebo; E. 12 μg formoterol plus 40 μg ipratropium plus 1 puff placebo; F. 4 puffs placebo. On each study day, Spirometric indices and vital signs were measured at 5, 10, 15 and 60 minutes, and hourly thereafter up to and including 12 hours after study drug administration. Mean peak FEV1 change (primary endpoint) was maximum with the administration of the combination of ipratropium and formoterol (335.2 ml, SE 24.6), and it differed significantly from the observed peak changes following single administration of the two tested doses of ipratropium (p<0.05 and p<0.05 respectively). Safety and tolerability were satisfactory throughout the study.