Meltzer Eli O, Philip George, Weinstein Steven F, LaForce Craig F, Malice Marie-Pierre, Dass S Balachandra, Santanello Nancy C, Reiss Theodore F
Allergy and Asthma Medical Group and Research Center, San Diego, CA 92109, USA.
Am J Rhinol. 2005 Nov-Dec;19(6):591-8.
Nighttime problems constitute a significant burden on the quality of life of patients with seasonal allergic rhinitis (SAR). The aim of this study was to evaluate the effectiveness of montelukast on nighttime AR symptoms.
In seven multicenter, double-blind, parallel-group trials, nighttime problems were assessed as the nighttime symptoms score (NSS), an average of three individual symptom scores: difficulty going to sleep, nighttime awakening, and nasal congestion on awakening (each rated 0 = none to 3 = severe). Patients (aged 15-82 years) were randomized to receive montelukast, 10 mg (n = 1751), placebo (n = 1557), or the positive control loratadine, 10 mg (n = 1616).
In a combined analysis, changes from baseline (mean +/- SE) in NSS were -0.28 +/- 0.01, -0.16 +/- 0.01, and -0.24 +/- 0.01 for the montelukast, placebo, and loratadine groups, respectively. Difference versus placebo in least-squares mean change from baseline were -0.11 (95% confidence interval, -0.14, -0.08; p < or = 0.001) for montelukast and -0.09 (-0.12, -0.06; p < or = 0.001) for loratadine. Strong baseline correlations (R > 0.70; p < 0.001) of NSS and two of its individual symptoms with the sleep domain of the validated Rhinoconjunctivitis Quality of Life Questionnaire support the validity and importance of measuring nighttime morbidity in SAR. Furthermore, a clinically important benefit of montelukast on the nighttime impact of SAR was shown using an analysis anchored on the Patient's Global Evaluation.
These data underscore the importance of nighttime problems in patients with SAR and the need to treat nighttime symptoms. In these studies, montelukast significantly improved the NSS, a clinically relevant and valid measure in patients with SAR.
夜间问题给季节性变应性鼻炎（SAR）患者的生活质量带来了沉重负担。本研究旨在评估孟鲁司特对夜间变应性鼻炎症状的疗效。
在7项多中心、双盲、平行组试验中，夜间问题通过夜间症状评分（NSS）进行评估，该评分是3项个体症状评分的平均值：入睡困难、夜间觉醒以及醒来时鼻塞（每项评分0 = 无至3 = 严重）。患者（年龄15 - 82岁）被随机分为接受10 mg孟鲁司特（n = 1751）、安慰剂（n = 1557）或10 mg阳性对照药氯雷他定（n = 1616）。
在一项合并分析中，孟鲁司特组、安慰剂组和氯雷他定组的NSS自基线的变化（均值±标准误）分别为 - 0.28±0.01、 - 0.16±0.01和 - 0.24±0.01。孟鲁司特组和氯雷他定组自基线的最小二乘均值变化与安慰剂组相比的差异分别为 - 0.11（95%置信区间， - 0.14， - 0.08；p≤0.001）和 - 0.09（ - 0.12， - 0.06；p≤0.001）。NSS及其两项个体症状与经过验证的变应性鼻炎生活质量问卷的睡眠领域具有很强的基线相关性（R>0.70；p<0.001），这支持了在SAR中测量夜间发病率的有效性和重要性。此外，使用基于患者整体评估的分析显示，孟鲁司特对SAR的夜间影响具有临床重要益处。
这些数据强调了夜间问题在SAR患者中的重要性以及治疗夜间症状的必要性。在这些研究中，孟鲁司特显著改善了NSS，这是SAR患者中一项具有临床相关性和有效性的指标。
