Malo J L, Ghezzo H, Trudeau C, L'Archevêque J, Cartier A
Department of Chest Medicine, Hôpital du Sacré-Coeur, Montreal, Quebec, Canada.
J Allergy Clin Immunol. 1992 Feb;89(2):567-74. doi: 10.1016/0091-6749(92)90324-u.
The duration of the blocking effect of salmeterol (50 micrograms), albuterol (200 micrograms), and a placebo were compared in a double-blind study in 12 adult subjects with asthma who underwent hyperventilation tests with cold dry air (-20 degrees C) on 4 study days. On the first day, the hyperventilation test was performed at various time intervals (baseline, 1, 4, 6, 8, 12, and 24 hours) with spontaneous functional recovery between each test to determine the within-day within-subject variability of the response. The response was assessed by interpolating the dose of cold dry air causing a 20% fall in FEV1. On the 3 remaining days, separated by an interval of at least 5 days, the active or placebo medication was administered after spontaneous recovery from the first hyperventilation test. Spirometry was assessed 15 minutes and 1 hour later. The hyperventilation test was then performed and repeated 4 hours after administration of the drug. The test was repeated 6, 8, 12, and 24 hours later to detect any significant blocking effect. The improvement in FEV1 15 minutes and 1 hour after the drug was administered was 19.8% and 20.4%, as compared to baseline for albuterol, and 16.3% and 16.8% for salmeterol (not significant). The mean duration of the blocking effect was 0.25 hour for the placebo, 3.5 hours for albuterol, and 15.9 hours for salmeterol (F = 24.5; p less than 0.001; Newman-Keul's test was significant for every contrast). Eight of the 12 subjects still demonstrated some blocking effect 8 hours after taking salmeterol; this was true for only one subject receiving albuterol.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项双盲研究中,对12名成年哮喘患者进行了比较,观察沙美特罗(50微克)、沙丁胺醇(200微克)和安慰剂的阻滞作用持续时间。在4个研究日,这些患者接受了冷干空气(-20摄氏度)过度通气试验。第一天,在不同时间间隔(基线、1、4、6、8、12和24小时)进行过度通气试验,每次试验间有自发功能恢复,以确定日内受试者内反应变异性。通过推算使第一秒用力呼气量(FEV1)下降20%的冷干空气剂量来评估反应。在接下来至少间隔5天的3天里,在第一次过度通气试验自发恢复后给予活性药物或安慰剂。给药15分钟和1小时后评估肺量计指标。然后进行过度通气试验,并在给药后4小时重复。在给药后6、8、12和24小时重复试验,以检测任何显著的阻滞作用。与基线相比,沙丁胺醇给药后15分钟和1小时FEV1的改善分别为19.8%和20.4%,沙美特罗为16.3%和16.8%(无显著差异)。安慰剂的平均阻滞作用持续时间为0.25小时,沙丁胺醇为3.5小时,沙美特罗为15.9小时(F = 24.5;p < 0.001;Newman-Keul检验对每个对比均有显著意义)。12名受试者中有8名在服用沙美特罗8小时后仍表现出一定的阻滞作用;而接受沙丁胺醇的受试者中只有1名如此。(摘要截选于第250词)