Fish J E, Kemp J P, Lockey R F, Glass M, Hanby L A, Bonuccelli C M
Jefferson Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Clin Ther. 1997 Jul-Aug;19(4):675-90. doi: 10.1016/s0149-2918(97)80092-6.
The efficacy of the oral leukotriene-receptor antagonist zafirlukast was assessed as maintenance therapy for patients with mild-to-moderate asthma. A total of 762 patients aged 12 to 76 years were enrolled in a 13-week, multicenter, double-masked, placebo-controlled, parallel-group trial and randomly assigned to receive either zafirlukast (20 mg twice daily) or placebo. Patients were maintained on as-needed beta-agonist therapy throughout the study and had to have a cumulative daytime asthma symptoms score > or = 8 (on a daily scale of 0 to 3) over 7 consecutive days before randomization. Efficacy was assessed by changes in symptoms, beta-agonist use, and pulmonary function. Safety was assessed by adverse experiences, laboratory test results, physical examination, and electrocardiography. Zafirlukast significantly decreased daytime asthma symptoms scores (-26.5%), nighttime awakenings (-19.8%), mornings with asthma (-29.0%), and beta-agonist use (-22.3%) and significantly increased morning peak expiratory flow rate (6.9%) and forced expiratory volume in 1 second (6.3%) compared with placebo. Changes in symptoms, beta-agonist use, and pulmonary function occurred within 2 days of zafirlukast treatment and continued throughout the trial. Zafirlukast was well tolerated. Pharyngitis and headache were the most common adverse events, occurring with similar frequency in both the zafirlukast and placebo groups. No clinically significant changes were observed in laboratory test results, findings on physical examination, or electrocardiographic findings. We conclude that zafirlukast produces early and sustained effects in the treatment of mild-to-moderate asthma.
评估了口服白三烯受体拮抗剂扎鲁司特作为轻度至中度哮喘患者维持疗法的疗效。共有762名年龄在12至76岁的患者参加了一项为期13周的多中心、双盲、安慰剂对照、平行组试验，并被随机分配接受扎鲁司特（每日两次，每次20毫克）或安慰剂治疗。在整个研究过程中，患者按需接受β受体激动剂治疗，并且在随机分组前连续7天的日间哮喘症状累积评分≥8（每日评分范围为0至3）。通过症状变化、β受体激动剂使用情况和肺功能来评估疗效。通过不良事件、实验室检查结果、体格检查和心电图来评估安全性。与安慰剂相比，扎鲁司特显著降低了日间哮喘症状评分（-26.5%）、夜间觉醒次数（-19.8%）、有哮喘症状的早晨次数（-29.0%）以及β受体激动剂的使用量（-22.3%），并显著提高了早晨呼气峰值流速（6.9%）和1秒用力呼气量（6.3%）。症状、β受体激动剂使用情况和肺功能的变化在扎鲁司特治疗的2天内出现，并在整个试验过程中持续存在。扎鲁司特耐受性良好。咽炎和头痛是最常见的不良事件，在扎鲁司特组和安慰剂组中出现的频率相似。实验室检查结果、体格检查结果或心电图检查结果均未观察到具有临床意义的变化。我们得出结论，扎鲁司特在治疗轻度至中度哮喘方面产生早期且持续的效果。
