Lockey R F, DuBuske L M, Friedman B, Petrocella V, Cox F, Rickard K
Division of Allergy and Immunology, University of South Florida College of Medicine, Tampa 33612, USA.
Chest. 1999 Mar;115(3):666-73. doi: 10.1378/chest.115.3.666.
To evaluate the effect of salmeterol on asthma-specific quality of life in patients experiencing significant nocturnal symptoms.
Randomized, double-blind, placebo-controlled, multicenter clinical trial.
Allergy/respiratory care clinics.
Nonsmokers > or = 12 years of age with nocturnal asthma symptoms on at least 6 of 14 days during screening and > or = 15% decrease in peak expiratory flow (PEF) from baseline on nocturnal awakening at least once during screening.
Salmeterol, 42 microg, or placebo twice daily. Patients were allowed to continue theophylline, inhaled corticosteroids, and "as-needed" albuterol.
Outcome measures included Asthma Quality of Life Questionnaire (AQLQ) global and individual domain scores, FEV1, PEF, nighttime awakenings, asthma symptoms, and supplemental albuterol use. Mean change from baseline for the global and domain AQLQ scores was significantly greater (p < or = 0.005) with salmeterol compared with placebo. At week 12, salmeterol significantly (p < 0.001 compared with placebo) increased mean change from baseline in FEV1, morning and evening PEF, percentage of symptom-free days, percentage of nights with no awakenings due to asthma, and the percentage of days and nights with no supplemental albuterol use. Significant improvements in PEF were observed after treatment with salmeterol regardless of concomitant treatment with theophylline (p < 0.05).
These results provide evidence that validates the role of salmeterol in improving quality of life in patients with moderate persistent asthma who exhibited nocturnal asthma symptoms and supports the efficacy of salmeterol compared with that of placebo (ie, "as-needed" albuterol).
评估沙美特罗对有明显夜间症状的哮喘患者哮喘特异性生活质量的影响。
随机、双盲、安慰剂对照、多中心临床试验。
过敏/呼吸科诊所。
年龄≥12岁的非吸烟者，筛查期间14天中至少6天有夜间哮喘症状，且筛查期间至少有一次夜间醒来时呼气峰值流速（PEF）较基线下降≥15%。
沙美特罗42微克，或安慰剂，每日两次。患者可继续使用茶碱、吸入性糖皮质激素和“按需”使用沙丁胺醇。
结果指标包括哮喘生活质量问卷（AQLQ）总体及各领域得分、第一秒用力呼气容积（FEV1）、PEF、夜间觉醒次数、哮喘症状及沙丁胺醇补充使用情况。与安慰剂相比，沙美特罗治疗后AQLQ总体及各领域得分较基线的平均变化显著更大（p≤0.005）。在第12周时，沙美特罗使FEV1、早晚PEF较基线的平均变化显著增加（与安慰剂相比p<0.001），无症状天数百分比、无哮喘觉醒的夜间百分比以及未补充使用沙丁胺醇的日夜百分比均显著增加。无论是否同时使用茶碱，沙美特罗治疗后PEF均有显著改善（p<0.05）。
这些结果提供了证据，证实了沙美特罗在改善有夜间哮喘症状的中度持续性哮喘患者生活质量方面的作用，并支持沙美特罗与安慰剂（即“按需”使用的沙丁胺醇）相比的疗效。
