Rennard S I, Anderson W, ZuWallack R, Broughton J, Bailey W, Friedman M, Wisniewski M, Rickard K
University of Nebraska Medical Center, Omaha, Nebraska, USA.
Am J Respir Crit Care Med. 2001 Apr;163(5):1087-92. doi: 10.1164/ajrccm.163.5.9903053.
Chronic obstructive pulmonary disease (COPD) is a condition in which continuous bronchodilation may have clinical advantages. This study evaluated salmeterol, a beta-agonist bronchodilator with a duration of action substantially longer than that of short-acting beta-agonists, compared with ipratropium, an anticholinergic bronchodilator, and placebo in patients with COPD. Four hundred and five patients with COPD received either salmeterol 42 microg twice daily, ipratropium bromide 36 microg four times daily, or placebo for 12 wk in this randomized, double-blind, parallel-group study. Patients were stratified on the basis of bronchodilator response to albuterol (> 12% and > 200-ml improvement) and were randomized within each stratum. Bronchodilator response was measured over 12 h four times during the treatment period. Salmeterol provided similar maximal bronchodilatation to ipratropium but had a longer duration of action and a more constant bronchodilatory effect with no evidence of bronchodilator tolerance. Both active treatments were well tolerated. Salmeterol was an effective bronchodilator with a consistent effect over this 12-wk study in patients with COPD, including those "unresponsive" to albuterol. The long duration of action of salmeterol offers the advantage of twice daily dosing compared with the required four times a day dosing with ipratropium.
慢性阻塞性肺疾病(COPD)是一种持续支气管扩张可能具有临床益处的病症。本研究评估了沙美特罗,一种作用持续时间明显长于短效β受体激动剂的β受体激动剂支气管扩张剂,与异丙托溴铵(一种抗胆碱能支气管扩张剂)及安慰剂相比,在慢性阻塞性肺疾病患者中的疗效。在这项随机、双盲、平行组研究中,405例慢性阻塞性肺疾病患者接受了每日两次42微克沙美特罗、每日四次36微克异丙托溴铵或安慰剂治疗,为期12周。患者根据对沙丁胺醇的支气管扩张反应(改善>12%且>200毫升)进行分层,并在各层内随机分组。在治疗期间,四次测量12小时内的支气管扩张反应。沙美特罗与异丙托溴铵产生相似的最大支气管扩张作用,但作用持续时间更长,支气管扩张作用更稳定,且无支气管扩张剂耐受性的证据。两种活性治疗耐受性均良好。在这项针对慢性阻塞性肺疾病患者的为期12周的研究中,包括那些对沙丁胺醇“无反应”的患者,沙美特罗是一种有效的支气管扩张剂,效果持续稳定。与异丙托溴铵每日需给药四次相比,沙美特罗作用持续时间长,具有每日给药两次的优势。