Bisgaard Hans, Flores-Nunez Alejandro, Goh Anne, Azimi Parvin, Halkas Andrew, Malice Marie-Pierre, Marchal Jean-Louis, Dass S Balachandra, Reiss Theodore F, Knorr Barbara A
Danish Pediatric Asthma Center, Department of Pediatrics, Copenhagen University Hospital, Gentofte, DK-2900 Copenhagen, Denmark.
Am J Respir Crit Care Med. 2008 Oct 15;178(8):854-60. doi: 10.1164/rccm.200706-910OC. Epub 2008 Jun 26.
A pilot study (Bisgaard H; Study Group on Montelukast and Respiratory Syncytial Virus. A randomized trial of montelukast in respiratory syncytial virus postbronchiolitis. Am J Respir Crit Care Med 2003;167:379-383) reported the efficacy of montelukast in post-respiratory syncytial virus (RSV) bronchiolitic respiratory symptoms.
To evaluate the efficacy and safety of montelukast, 4 and 8 mg, in treating recurrent respiratory symptoms of post-RSV bronchiolitis in children in a large, multicenter study.
This was a double-blind study of 3- to 24-month-old children who had been hospitalized for a first or second episode of physician-diagnosed RSV bronchiolitis and who tested positive for RSV. Patients (n = 979) were randomized to placebo or to montelukast at 4 or 8 mg/day for 4 weeks (period I) and 20 weeks (period II). The primary end point was percentage symptom-free days (%SFD; day with no daytime cough, wheeze, and shortness of breath, and no nighttime cough).
No significant differences were seen between montelukast and placebo in %SFD over period I: mean +/- SD for placebo and for montelukast at 4 and 8 mg were 37.0 +/- 30.7, 38.6 +/- 30.4, and 38.5 +/- 29.9, respectively. Least-squares mean differences (95% confidence interval) between montelukast (4 mg) and placebo and between montelukast (8 mg) and placebo were 1.9% (-2.9, 6.7) and 1.6% (-3.2, 6.5), respectively. Secondary end points were similar across treatments. Both doses were generally well tolerated. During the first two treatment weeks, average %SFD was approximately 29%. In post hoc analyses of patients (n = 523) with persistent symptoms (%SFD < or = 30% over Weeks 1-2), differences in %SFD were seen between montelukast and placebo over Weeks 3-24: difference were 5.7 (0.0, 11.3) for montelukast (4 mg) minus placebo and 5.9 (0.1, 11.7) for montelukast (8 mg) minus placebo.
In this study, montelukast did not improve respiratory symptoms of post-RSV bronchiolitis in children.
一项初步研究（比斯gaard H；孟鲁司特与呼吸道合胞病毒研究小组。孟鲁司特治疗呼吸道合胞病毒毛细支气管炎后呼吸道症状的随机试验。《美国呼吸与危重症医学杂志》2003年；167:379 - 383）报告了孟鲁司特对呼吸道合胞病毒（RSV）毛细支气管炎后呼吸道症状的疗效。
在一项大型多中心研究中，评估4毫克和8毫克孟鲁司特治疗儿童RSV毛细支气管炎后反复出现的呼吸道症状的疗效和安全性。
这是一项针对3至24个月大儿童的双盲研究，这些儿童因医生诊断的首次或第二次RSV毛细支气管炎住院且RSV检测呈阳性。患者（n = 979）被随机分为安慰剂组或每天服用4毫克或8毫克孟鲁司特组，为期4周（第一阶段）和20周（第二阶段）。主要终点是无症状天数百分比（%SFD；无日间咳嗽、喘息和呼吸急促以及无夜间咳嗽的天数）。
在第一阶段，孟鲁司特组和安慰剂组的%SFD无显著差异：安慰剂组以及4毫克和8毫克孟鲁司特组的平均值±标准差分别为37.0±30.7、38.6±30.4和38.5±29.9。孟鲁司特（4毫克）与安慰剂之间以及孟鲁司特（8毫克）与安慰剂之间的最小二乘均值差异（95%置信区间）分别为1.9%（-2.9，6.7）和1.6%（-3.2，6.5）。各治疗组的次要终点相似。两种剂量一般耐受性良好。在前两个治疗周期间，平均%SFD约为29%。在对持续有症状患者（n = 523）（第1 - 2周%SFD≤30%）的事后分析中，在第3 - 24周，孟鲁司特组和安慰剂组的%SFD存在差异：孟鲁司特（4毫克）减去安慰剂的差异为5.7（0.0，11.3），孟鲁司特（8毫克）减去安慰剂的差异为5.9（0.1，11.7）。
在本研究中，孟鲁司特未改善儿童RSV毛细支气管炎后的呼吸道症状。
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