Price D, Dutchman D, Mawson A, Bodalia B, Duggan S, Todd P
Department of General Practice and Primary Care, University of Aberdeen, Aberdeen AB25 2AY, UK.
Thorax. 2002 Sep;57(9):791-8. doi: 10.1136/thorax.57.9.791.
Previous studies have indicated the benefits of adding long acting beta(2) agonists to inhaled corticosteroids in the maintenance treatment of moderate to severe asthma. The effects of adding eformoterol to corticosteroids on asthma control and exacerbations in patients with mild to moderate asthma were studied.
After a run in period of 7-14 days on existing medication, 663 symptomatic patients were randomised to receive budesonide Turbohaler 400 microg twice daily together with either eformoterol Turbohaler 9 micro g (delivered dose) or placebo twice daily. After 4 weeks patients whose asthma was well controlled (n=505) were re-randomised to receive budesonide 400 microg daily and either eformoterol 9 micro g or placebo twice daily for a further 6 months.
Patients receiving eformoterol achieved asthma control 10 days sooner than those receiving budesonide alone, and improvements in lung function, symptoms, quality of life, and relief beta(2) agonist use were significantly greater with eformoterol. During the 6 month follow up the frequency of mild exacerbations was significantly lower in the eformoterol group than in those receiving budesonide alone (7.2 versus 10.5 per patient, 95% confidence interval for ratio 0.49 to 0.96, p=0.03). The time to first day of poorly controlled asthma was 97 days in the eformoterol group compared with 42 days in the placebo group (p=0.003).
Adding eformoterol to a low or moderate dose of budesonide in mild asthma resulted in faster and more effective control than treatment with budesonide alone. Eformoterol allowed the corticosteroid dose to be reduced while also decreasing the rate of mild exacerbations compared with budesonide alone. These data suggest a therapeutic advantage of adding eformoterol to inhaled corticosteroids in patients with mild to moderate asthma.
既往研究表明,在中重度哮喘维持治疗中,在吸入性糖皮质激素基础上加用长效β₂受体激动剂有益。本研究探讨了在轻度至中度哮喘患者中,在糖皮质激素基础上加用埃佛特罗对哮喘控制及急性加重的影响。
663例有症状的患者在使用现有药物进行7至14天的导入期后,随机分为两组,分别接受布地奈德都保400μg每日两次,同时每日两次加用埃佛特罗都保9μg(输送剂量)或安慰剂。4周后,哮喘得到良好控制的患者(n = 505)再次随机分组,接受布地奈德400μg每日一次,同时每日两次加用埃佛特罗9μg或安慰剂,持续6个月。
与单纯接受布地奈德治疗的患者相比,接受埃佛特罗治疗的患者提前10天实现哮喘控制,且埃佛特罗治疗在肺功能、症状、生活质量及缓解期β₂受体激动剂使用方面的改善更为显著。在6个月的随访期间,埃佛特罗组轻度急性加重的频率显著低于单纯接受布地奈德治疗的患者(每位患者分别为7.2次和10.5次,比值的95%置信区间为0.49至0.96,p = 0.03)。埃佛特罗组哮喘控制不佳的首日时间为97天,而安慰剂组为42天(p = 0.003)。
在轻度哮喘患者中,在低剂量或中等剂量布地奈德基础上加用埃佛特罗比单纯使用布地奈德治疗能更快、更有效地控制哮喘。与单纯使用布地奈德相比,埃佛特罗在减少糖皮质激素剂量的同时,还降低了轻度急性加重的发生率。这些数据表明,在轻度至中度哮喘患者中,在吸入性糖皮质激素基础上加用埃佛特罗具有治疗优势。