孟鲁司特对学龄前儿童气道高反应性的治疗作用
2007/03/09
Fahed Hakim等采用双盲随机、安慰剂对照、交叉设计研究，对26例学龄前儿童（3.3～6.0岁，女性8例）给予孟鲁司特4mg或安慰剂口服4w，其间清洗期为2w，测定其激发试验PC20值，并对应用安慰剂和孟鲁司特治疗后的PC20值进行比较。
作者发现孟鲁司特治疗4w后，平均PC20值为4.79 ± 4.69 mg/mL，而服用安慰剂4w后平均PC20 为2.07 ± 2.37 mg/mL (p = 0.001)。孟鲁司特/安慰剂PC20 比值为2.56，其95%可信区间为1.71～3.99。PC20差值的中位数为激发物的1个升级剂量（每个升级剂量间相差3倍），其95%可信区间为0.5～1.5。作者认为，与对照组相比，应用孟鲁司特治疗4w可降低气道高反应性。
作者发现孟鲁司特治疗4w后，平均PC20值为4.79 ± 4.69 mg/mL，而服用安慰剂4w后平均PC20 为2.07 ± 2.37 mg/mL (p = 0.001)。孟鲁司特/安慰剂PC20 比值为2.56，其95%可信区间为1.71～3.99。PC20差值的中位数为激发物的1个升级剂量（每个升级剂量间相差3倍），其95%可信区间为0.5～1.5。作者认为，与对照组相比，应用孟鲁司特治疗4w可降低气道高反应性。
（赵海涛 沈阳军区总医院呼吸内科 110016 摘译）
（CHEST, 2007;131:180-186）
Fahed Hakim, MD; Daphna Vilozni, PhD; Adi Adler, MD; Galit Livnat, MD; Asher Tal, MD and Lea Bentur, MD
Abstract
Introduction: The effect of montelukast therapy on bronchial hyperreactivity (BHR) as measured by the methacholine challenge test in preschool children has not yet been reported.
Objective: To determine the effect of montelukast (4 mg/d) on BHR as evaluated by a provocative concentration of a substance causing a 20% fall in FEV1 (PC20) values in preschool asthmatic children.
Patients: A total of 26 preschool children (8 girls) aged 3.3 to 6.0 years (mean [± SD] age, 4.7 ± 0.8 years) with mild asthma.
Design: Double-blind randomized, placebo controlled, crossover study. Each child received 4 weeks of treatment with 4 mg of either montelukast or placebo separated by a 2-week washout period. Primary outcomes were PC20 values and the stage number (triple dose) at which FEV1 values dropped by 20%. Post-montelukast therapy PC20 was compared to those for the post-placebo period.
Results: Following 4 weeks of montelukast treatment, the mean PC20 was 4.79 ± 4.69 mg/mL, while after 4 weeks of placebo the mean PC20 was 2.07 ± 2.37 mg/mL (p = 0.001). The montelukast/placebo ratio for PC20 was 2.56 with a 95% confidence interval (CI) of 1.71 to 3.99. The median difference in stage was one triple dose with a 95% CI of 0.5 to 1.5.
Conclusions: Four weeks of treatment with montelukast resulted in a decreased BHR compared with placebo.
Key Words: bronchial reactivity·leukotrienes·pediatric asthma·preschool
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