丙酸氟替卡松/沙美特罗联合用药与孟鲁司特治疗持续性哮喘的比较
Fluticasone propionate/salmeterol combination compared with montelukast for the treatment of persistent asthma.
作者信息
Pearlman David S, White Martha V, Lieberman Allen K, Pepsin Pamela J, Kalberg Chris, Emmett Amanda, Bowers Brian, Rickard Kathleen A, Dorinsky Paul
机构信息
Colorado Allergy and Asthma Centers, PC, Denver 80230, USA.
出版信息
Ann Allergy Asthma Immunol. 2002 Feb;88(2):227-35. doi: 10.1016/S1081-1206(10)62001-7.
BACKGROUND
Asthma is a chronic disease characterized by inflammation and bronchoconstriction. Medications that are able to effectively treat both components are advantageous.
OBJECTIVE
To compare the efficacy of an inhaled corticosteroid and a long-acting beta2-agonist combination product with a leukotriene antagonist for initial maintenance therapy in patients who were symptomatic while receiving short-acting beta2-agonists alone.
METHODS
A 12-week, randomized, double-blind, double-dummy, multicenter study was conducted in 432 patients 15 years of age and older with persistent asthma who were symptomatic on short-acting beta2-agonists alone. Fluticasone propionate 100 microg and salmeterol 50 microg combination product (FSC) twice daily or montelukast 10 mg once daily was administered.
RESULTS
At endpoint, compared with montelukast, FSC significantly increased morning predose forced expiratory volume in 1 second (0.61 +/- 0.03 L vs 0.32 +/- 0.03 L), morning peak expiratory flow rate (peak expiratory flow rate; 81.4 +/- 5.9 L/minute vs 41.9 +/- 4.8 L/minute), evening peak expiratory flow rate (64.6 +/- 5.3 L/minute vs 38.8 +/- 4.7 L/minute), the percentage of symptom-free days (40.3 +/- 2.9% vs 27.0 +/- 2.7%), the percentage of rescue-free days (53.4 +/- 2.8% vs 26.7 +/- 2.5%), and the percentage of nights with no awakenings (29.8 +/- 2.5% vs 19.6 +/- 2.1%) (P < or = 0.011, all comparisons). At endpoint, FSC significantly reduced asthma symptom scores (-1.0 +/- 0.1 vs -0.7 +/- 0.1) and rescue albuterol use (-3.6 +/- 0.2 puffs/day vs -2.2 +/- 0.2 puffs/day) compared with montelukast (P < 0.001). At endpoint, patients treated with FSC also had a significantly greater improvement in quality of life scores and were more satisfied with their treatment compared with montelukast-treated patients (P < or = 0.001). Both treatments were well tolerated.
CONCLUSIONS
Initial maintenance therapy with FSC provides greater improvement in asthma control and patient satisfaction than montelukast.
背景
哮喘是一种以炎症和支气管收缩为特征的慢性疾病。能够有效治疗这两个方面的药物具有优势。
目的
比较吸入性糖皮质激素与长效β2受体激动剂联合制剂和白三烯拮抗剂在仅接受短效β2受体激动剂治疗时仍有症状的患者初始维持治疗中的疗效。
方法
对432例15岁及以上的持续性哮喘患者进行了一项为期12周的随机、双盲、双模拟、多中心研究，这些患者仅使用短效β2受体激动剂时仍有症状。给予丙酸氟替卡松100微克和沙美特罗50微克联合制剂（FSC），每日两次，或孟鲁司特10毫克，每日一次。
结果
在研究终点，与孟鲁司特相比，FSC显著提高了早晨给药前1秒用力呼气容积（0.61±0.03升对0.32±0.03升）、早晨呼气峰值流速（呼气峰值流速；81.4±5.9升/分钟对41.9±4.8升/分钟）、晚上呼气峰值流速（64.6±5.3升/分钟对38.8±4.7升/分钟）、无症状天数百分比（40.3±2.9%对27.0±2.7%）、无需急救天数百分比（53.4±2.8%对26.7±2.5%）以及无觉醒夜间百分比（29.8±2.5%对19.6±2.1%）（所有比较，P≤0.011）。在研究终点，与孟鲁司特相比，FSC显著降低了哮喘症状评分（-1.0±0.1对-0.7±0.1）和急救用沙丁胺醇的使用量（-3.6±0.2喷/天对-2.2±0.2喷/天）（P<0.001）。在研究终点，与接受孟鲁司特治疗的患者相比，接受FSC治疗的患者在生活质量评分方面也有显著更大的改善，并且对治疗更满意（P≤0.001）。两种治疗的耐受性都良好。
结论
与孟鲁司特相比，FSC进行初始维持治疗能在哮喘控制和患者满意度方面带来更大改善。
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