Apter A J, Reisine S T, Willard A, Clive J, Wells M, Metersky M, McNally D, ZuWallack R L
Department of Medicine, University of Connecticut Health Center, Farmington 06030-3945, USA.
J Allergy Clin Immunol. 1996 Aug;98(2):295-301. doi: 10.1016/s0091-6749(96)70153-7.
Some recent clinical investigations suggest that regular use of inhaled bronchodilators may lead to deterioration in asthma control.
The purpose of this study was to evaluate the effect of albuterol dosing schedule on clinical outcome in subjects with moderate to severe stable asthma.
Seventeen adults were randomized to two 15-week treatment periods in a double-blind crossover design. Throughout the study, subjects were instructed to take two inhalations four times daily from an unlabeled "test" canister. In the four times daily and as-needed (QID + PRN) period, this canister contained albuterol; in the as-needed (PRN) period, it contained placebo. A "rescue" albuterol canister was available for as-needed use at all times. Inhaler actuations from both the test and rescue canisters were electronically recorded. Outcome measures included prednisone requirements, morning and evening symptoms and peak expiratory flow rates, total and nighttime rescue albuterol use, and asthma-specific quality of life.
The two treatment periods did not differ in symptoms, nighttime albuterol use, or asthma quality of life. During the QID+PRN period both morning and evening peak expiratory flow rates were significantly higher (p < 0.01 and 0.001, respectively) and total rescue use of albuterol was significantly less (p < 0.05) than the PRN period. Days on prednisone tended to be lower in the regular dosing period (p = 0.08).
In our sample of patients with moderate to severe asthma, four times daily dosing of albuterol did not lead to deterioration of asthma control.
近期一些临床研究表明，定期使用吸入性支气管扩张剂可能导致哮喘控制情况恶化。
本研究旨在评估沙丁胺醇给药方案对中度至重度稳定期哮喘患者临床结局的影响。
17名成年人采用双盲交叉设计随机分为两个为期15周的治疗阶段。在整个研究过程中，指导受试者每天从一个无标签的“测试”药罐中吸入四次，每次两喷。在每日四次按需使用（QID + PRN）阶段，该药罐含有沙丁胺醇；在按需使用（PRN）阶段，该药罐含有安慰剂。随时可按需使用一个“急救”沙丁胺醇药罐。测试药罐和急救药罐的吸入启动情况均通过电子记录。观察指标包括泼尼松的使用需求、早晚症状及呼气峰值流速、沙丁胺醇的总使用量及夜间急救使用量，以及哮喘特异性生活质量。
两个治疗阶段在症状、夜间沙丁胺醇使用量或哮喘生活质量方面无差异。在QID + PRN阶段，早晚呼气峰值流速均显著更高（分别为p < 0.01和0.001），且沙丁胺醇的总急救使用量显著低于PRN阶段（p < 0.05）。在常规给药阶段，使用泼尼松的天数往往更低（p = 0.08）。
在我们的中度至重度哮喘患者样本中，每日四次使用沙丁胺醇并未导致哮喘控制情况恶化。
