Chukwu C, Okpapi J, Ige M O, Obodo J O
Department of Medicine, Lagos University Teaching Hospital, Nigeria.
West Afr J Med. 2000 Apr-Jun;19(2):111-9.
The efficacy and safety of the oral leukotriene receptor antagonist Zafirlukast ('Accolate') was assessed as maintenance therapy for black (Nigerian) patients with mild to moderate asthma. A total of eighty-one patients aged 16-70 years were screened and sixty patients were enrolled in a 7-week multicenter open study to receive 20 mg of 'Accolate' twice daily. Those enrolled had FEV1 > or = 60%, reversibility > or = 15% and cumulative daytime asthma symptoms score > or = 10 over seven consecutive days before visit 2 to be considered eligible to receive trial therapy, and the patients were maintained on as required beta 2-agonist therapy. Efficacy was assessed by changes in symptoms, number of times beta 2-agonist was used and results of pulmonary function tests. Safety was assessed by adverse event experiences, results of laboratory tests and physical examination. At the endpoint, patients reported a statistically significant increase in lung function and a significant reduction in episodes of asthma symptoms either in the morning, day or night. The mean beta 2-agonist use was also statistically reduced over the weeks as treatment progressed while the cumulative daytime total asthma score showed a sharp decline following drug use. Change in symptoms, beta 2-agonist use and pulmonary function occurred within one week of Zafirlukast treatment and continued throughout the trial. Zafirlukast was well tolerated. Headaches and pneumonia were the only side effects in three patients and these were not considered to be related to trial therapy. No clinically significant changes were observed in laboratory test results, or on physical examination. We conclude that Zafirlukast ('Accolate') 20 mg b.d. is an effective and well tolerated medication for maintenance therapy in black (Nigerian) patients with mild-to-moderate asthma.
对口服白三烯受体拮抗剂扎鲁司特（“安可来”）作为患有轻至中度哮喘的黑人（尼日利亚）患者维持治疗的疗效和安全性进行了评估。总共筛查了81名年龄在16至70岁的患者，60名患者被纳入一项为期7周的多中心开放研究，每天两次接受20毫克“安可来”治疗。入选者在第2次就诊前FEV1≥60%、可逆性≥15%且连续7天累积日间哮喘症状评分≥10，被认为有资格接受试验治疗，患者按需维持使用β2激动剂治疗。通过症状变化、β2激动剂使用次数和肺功能测试结果评估疗效。通过不良事件经历、实验室测试结果和体格检查评估安全性。在研究终点，患者报告肺功能有统计学意义的增加，且在早晨、白天或晚上哮喘症状发作次数有显著减少。随着治疗进展，在数周内平均β2激动剂使用量也有统计学意义的减少，而累积日间哮喘总评分在用药后急剧下降。症状、β2激动剂使用和肺功能的变化在扎鲁司特治疗1周内出现，并在整个试验过程中持续存在。扎鲁司特耐受性良好。3名患者仅出现头痛和肺炎这两种副作用，且这些副作用被认为与试验治疗无关。实验室测试结果或体格检查未观察到具有临床意义的变化。我们得出结论，每日两次服用20毫克扎鲁司特（“安可来”）是患有轻至中度哮喘的黑人（尼日利亚）患者维持治疗的一种有效且耐受性良好的药物。
