van Adelsberg J, Philip G, Pedinoff A J, Meltzer E O, Ratner P H, Menten J, Reiss T F
Merck Research Laboratories, Rahway, NJ, USA.
Allergy. 2003 Dec;58(12):1268-76. doi: 10.1046/j.1398-9995.2003.00261.x.
Proinflammatory mediators such as the cysteinyl leukotrienes are important in the pathophysiology of allergic rhinitis. This study evaluated the efficacy and tolerability of montelukast, a cysteinyl leukotriene receptor antagonist, given once daily in the morning for treatment of seasonal (fall) allergic rhinitis for 4 weeks.
This was a randomized, double-blind trial with a placebo run-in and a 4-week treatment period. Patients (n = 1079) with a history of allergic rhinitis and a positive skin test to seasonal pollen allergens were assigned to placebo, montelukast 10 mg, or loratadine 10 mg. Symptoms were assessed with a daily diary.
Montelukast was more effective than placebo in improving scores for the primary endpoint of daytime nasal symptoms (P = 0.003) and the secondary endpoints of night-time, composite, and daytime eye symptoms, patient's and physician's global evaluations of allergic rhinitis, and rhinoconjunctivitis quality-of-life (P </= 0.006). The positive control loratadine also improved scores for the primary endpoint (P </= 0.001) and the majority of the secondary endpoints (P < 0.03). When analyzed by week, the treatment effect of montelukast was more persistent than loratadine over all 4 weeks of treatment.
Montelukast provided effective relief of seasonal allergic rhinitis symptoms when given once daily in the morning, showed significant and sustained improvement in symptoms of allergic rhinitis over 4 weeks of treatment, and was well-tolerated.
半胱氨酰白三烯等促炎介质在变应性鼻炎的病理生理学中起重要作用。本研究评估了每日早晨服用一次的半胱氨酰白三烯受体拮抗剂孟鲁司特治疗季节性（秋季）变应性鼻炎4周的疗效和耐受性。
这是一项随机、双盲试验，有安慰剂导入期和4周治疗期。有变应性鼻炎病史且对季节性花粉过敏原皮肤试验呈阳性的患者（n = 1079）被分配至安慰剂组、孟鲁司特10 mg组或氯雷他定10 mg组。通过每日日记评估症状。
孟鲁司特在改善白天鼻部症状这一主要终点指标得分方面比安慰剂更有效（P = 0.003），在改善夜间、综合及白天眼部症状、患者和医生对变应性鼻炎的整体评估以及鼻结膜炎生活质量这些次要终点指标方面也更有效（P≤0.006）。阳性对照药氯雷他定也改善了主要终点指标得分（P≤0.001）及大多数次要终点指标得分（P < 0.03）。按周分析时，在整个4周治疗期间，孟鲁司特的治疗效果比氯雷他定更持久。
孟鲁司特每日早晨服用一次可有效缓解季节性变应性鼻炎症状，在4周治疗期间变应性鼻炎症状有显著且持续的改善，并且耐受性良好。
