Meltzer Eli O, Lockey Richard F, Friedman Bruce F, Kalberg Chris, Goode-Sellers Stacey, Srebro Sharon, Edwards Lisa, Rickard Kathleen
Allergy & Asthma Medical Group & Research Center, San Diego, CA 92123, USA.
Mayo Clin Proc. 2002 May;77(5):437-45.
To compare the long-term effects of an inhaled corticosteroid with those of a leukotriene modifier on measures of clinical efficacy, subject preference, and safety in patients with persistent asthma.
Between November 17, 1998, and May 26, 2000, we conducted a multicenter, randomized, double-blind, double-dummy, parallel-group study of patients aged 15 years or older with persistent asthma. The patients were symptomatic while taking short-acting beta2-agonists alone and were treated with fluticasone propionate (88 microg [2 puffs of 44 microg] twice daily) or montelukast (10 mg/d) for 24 weeks. Measures of pulmonary function, asthma symptoms, albuterol use, nighttime awakenings, physician assessments of efficacy, patient satisfaction, asthma-related quality of life, and safety were evaluated.
A total of 522 patients were randomized to receive fluticasone or montelukast, and 395 patients completed the study. At end point, treatment with fluticasone significantly improved pulmonary function, asthma symptom scores, the percentage of symptom-free days, rescue albuterol use, and the number of nighttime awakenings due to asthma when compared with montelukast (P< or = .002, each comparison). Significantly more patients were satisfied with fluticasone therapy (83%) compared with montelukast therapy (66%) (P<.001), and fluticasone therapy was rated as effective by a significantly greater portion of physicians (67%) than was montelukast therapy (54%) (P<.001). Treatment with fluticasone significantly improved asthma-related quality-of-life measures compared with montelukast (P< or =.01). The incidence of asthma exacerbations was similar in the fluticasone (19 patients, 7%) and montelukast (21 patients, 8%) treatment groups, although slightly more patients in the montelukast group were withdrawn from the study because of asthma exacerbations (6% vs 4%, respectively).
Long-term treatment with a low dose of inhaled fluticasone is more effective than oral montelukast as first-line maintenance therapy for the treatment of persistent asthma.
比较吸入性糖皮质激素与白三烯调节剂对持续性哮喘患者临床疗效、患者偏好及安全性指标的长期影响。
在1998年11月17日至2000年5月26日期间，我们对15岁及以上的持续性哮喘患者进行了一项多中心、随机、双盲、双模拟、平行组研究。这些患者仅使用短效β2受体激动剂时就有症状，并接受丙酸氟替卡松（88微克[2喷，每次44微克]，每日两次）或孟鲁司特（10毫克/天）治疗24周。对肺功能、哮喘症状、沙丁胺醇使用情况、夜间觉醒情况、医生对疗效的评估、患者满意度、哮喘相关生活质量及安全性指标进行了评估。
共有522例患者被随机分配接受氟替卡松或孟鲁司特治疗，395例患者完成了研究。在研究终点时，与孟鲁司特相比，氟替卡松治疗显著改善了肺功能、哮喘症状评分、无症状天数百分比、急救沙丁胺醇使用情况以及因哮喘导致的夜间觉醒次数（每项比较P≤0.002）。与孟鲁司特治疗（66%）相比，显著更多的患者对氟替卡松治疗满意（83%）（P<0.001），并且与孟鲁司特治疗（54%）相比，显著更大比例的医生认为氟替卡松治疗有效（67%）（P<0.001）。与孟鲁司特相比，氟替卡松治疗显著改善了哮喘相关生活质量指标（P≤0.01）。氟替卡松治疗组（19例患者，7%）和孟鲁司特治疗组（21例患者，8%）的哮喘加重发生率相似，尽管孟鲁司特组因哮喘加重退出研究的患者略多（分别为6%和4%）。
作为持续性哮喘的一线维持治疗，低剂量吸入性氟替卡松的长期治疗比口服孟鲁司特更有效。
