Martin R J, Kraft M, Beaucher W N, Kiechel F, Sublett J L, LaVallee N, Shilstone J
National Jewish Medical and Research Center, Denver, Colorado 80206, USA.
Ann Allergy Asthma Immunol. 1999 Aug;83(2):121-6. doi: 10.1016/S1081-1206(10)62622-1.
Nocturnal worsening of asthma is a common problem in asthma and is associated with increased morbidity and mortality. Long acting beta-2 agonists are considered long-term symptom control medications, especially for nocturnal symptoms.
To compare efficacy of an extended release oral beta-2 agonist, albuterol sulfate (Volmax), to a long-acting inhaled agent, salmeterol (Serevent) in the treatment of nocturnal asthma.
This was a multicenter double-blind, double-dummy, randomized, crossover design with a 1-week baseline period and two 3-week treatment periods separated by a 7 to 9-day washout. An optional 2-week, open-label phase was conducted to evaluate patient preference.
A total of 46 patients were included in the efficacy analysis. For the primary outcome variable of morning peak expiratory flow, there were similar and significant improvements over the 3-week treatment period for both medications compared with baseline (P < .001). Similar improvements were seen in the overnight change in PEF values (P < .001). The morning and overnight changes in FEV1 were not significantly different between treatment arms (P > .05). There were significant improvements in both treatment periods in regard to the percentage of nights without awakenings (baseline 53.6+/-5.3%), extended release albuterol 83.3+/-3.0% (P < .001), and salmeterol 88.8+/-2.4%. The percentage of patients who had no awakenings during treatment did not differ significantly for the two medications. Both treatments also resulted in a decrease in the use of rescue albuterol (extended release 2.66+/-0.35 puffs per day, salmeterol 1.85+/-0.29) from baseline (4.57+/-0.41, P < .001). There was a significant difference between groups (P = .001). The reasons why patients preferred one medication over the other varied.
Both extended release albuterol tablets and inhaled salmeterol resulted in similar bronchodilation and good control of nocturnal asthma symptoms.
哮喘夜间症状加重是哮喘常见问题，与发病率和死亡率增加相关。长效β2受体激动剂被视为长期症状控制药物，尤其适用于夜间症状。
比较缓释口服β2受体激动剂硫酸沙丁胺醇（万托林）与长效吸入剂沙美特罗（施立稳）治疗夜间哮喘的疗效。
这是一项多中心双盲、双模拟、随机交叉设计研究，有1周基线期和两个3周治疗期，中间间隔7至9天洗脱期。进行了一个为期2周的开放标签阶段以评估患者偏好。
共46例患者纳入疗效分析。对于早晨呼气峰值流速这一主要结局变量，与基线相比，两种药物在3周治疗期均有相似且显著的改善（P < 0.001）。在呼气峰值流速（PEF）值的夜间变化方面也有相似改善（P < 0.001）。治疗组间第一秒用力呼气容积（FEV1）的早晨和夜间变化无显著差异（P > 0.05）。两个治疗期在无觉醒夜晚的百分比方面均有显著改善（基线53.6±5.3%），缓释沙丁胺醇为83.3±3.0%（P < 0.001），沙美特罗为88.8±2.4%。两种药物治疗期间无觉醒的患者百分比无显著差异。两种治疗均使急救用沙丁胺醇的使用量从基线（4.57±0.41）减少（缓释剂每日2.66±0.35喷，沙美特罗1.85±0.29）（P < 0.001）。组间有显著差异（P = 0.001）。患者偏好一种药物而非另一种药物的原因各不相同。
缓释沙丁胺醇片和吸入用沙美特罗均产生相似的支气管舒张作用并能良好控制夜间哮喘症状。
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