Busse W, Nelson H, Wolfe J, Kalberg C, Yancey S W, Rickard K A
University of Wisconsin-Madison Medical School, Madison, WI, USA.
J Allergy Clin Immunol. 1999 Jun;103(6):1075-80. doi: 10.1016/s0091-6749(99)70182-x.
Salmeterol, a long-acting beta2 -agonist, and zafirlukast, a leukotriene receptor antagonist, are both indicated for the treatment of asthma in adolescent and adult patients.
We sought to compare the effect of 4 weeks of treatment with inhaled salmeterol xinafoate versus oral zafirlukast in the treatment of persistent asthma.
This was a randomized, double-blind, double-dummy, parallel-group, multicenter clinical trial. Patients, over 80% of whom were on a concurrent inhaled corticosteroid regimen, were treated for 4 weeks with either inhaled salmeterol xinafoate 42 microgram twice daily administered by means of a metered-dose inhaler or oral zafirlukast 20 mg twice daily. The primary efficacy measure was morning peak expiratory flow (PEF); secondary efficacy measures included evening PEF, asthma symptom scores, supplemental albuterol use, nighttime awakenings, sleep symptoms, asthma exacerbations, and FEV1.
Both inhaled salmeterol and oral zafirlukast resulted in within-group improvements from baseline in measures of pulmonary function, asthma symptoms, and supplemental albuterol use. Salmeterol treatment resulted in significantly greater improvements from baseline compared with zafirlukast for most efficacy measurements, including morning PEF (29.6 vs 13.0 L/min; P </= .001), percentage of symptom-free days (22.4% vs 8.8%; P </= .001), and percentage of days and nights with no supplemental albuterol use (30.5% vs 11.3%; P </= .001). There were no differences in safety profiles as assessed by adverse event monitoring.
In patients with persistent asthma, most of whom were concurrently using inhaled corticosteroids, treatment with inhaled salmeterol provided significantly greater improvement than oral zafirlukast in overall asthma control over the 4-week treatment period.
沙美特罗是一种长效β2受体激动剂，扎鲁司特是一种白三烯受体拮抗剂，二者均适用于青少年和成年哮喘患者的治疗。
我们旨在比较吸入用昔萘酸沙美特罗治疗4周与口服扎鲁司特治疗持续性哮喘的效果。
这是一项随机、双盲、双模拟、平行组、多中心临床试验。超过80%的患者同时接受吸入性糖皮质激素治疗，患者被随机分为两组，分别接受以下治疗，为期4周：通过定量吸入器每日两次吸入42微克吸入用昔萘酸沙美特罗，或每日两次口服20毫克扎鲁司特。主要疗效指标为早晨呼气峰值流速（PEF）；次要疗效指标包括晚上PEF、哮喘症状评分、沙丁胺醇补充使用情况、夜间觉醒、睡眠症状、哮喘加重情况及第一秒用力呼气容积（FEV1）。
吸入用沙美特罗和口服扎鲁司特治疗均使患者在肺功能、哮喘症状及沙丁胺醇补充使用情况的测量指标上较基线有组内改善。在大多数疗效测量指标上，与扎鲁司特相比，沙美特罗治疗使患者较基线有更显著的改善，包括早晨PEF（29.6对13.0升/分钟；P≤0.001）、无症状天数百分比（22.4%对8.8%；P≤0.001）以及未补充使用沙丁胺醇的白天和夜晚天数百分比（30.5%对11.3%；P≤0.001）。通过不良事件监测评估，二者安全性无差异。
在持续性哮喘患者中，大多数患者同时使用吸入性糖皮质激素，在4周治疗期内，吸入用沙美特罗治疗在总体哮喘控制方面比口服扎鲁司特带来的改善显著更大。
