孟鲁司特治疗5～14岁哮喘患儿的随机双盲对照研究

Montelukast for Chronic Asthma in 5 to 14 Year Old Children:A Randomized,Double-Blind Trial

目的:研究白三烯受体拮抗剂孟鲁司特治疗5～14岁哮喘患儿的临床疗效。方法:84例5～14岁哮喘患儿按照随机双盲对照研究分为两组各42例,其中治疗组给予孟鲁司特5 mg睡前口服,对照组给予安慰剂睡前口服,记录两组患儿晨间最大呼气峰流速值(PEFam)、晚间最大呼气峰流速值(PEFpm)、第1秒用力呼气量(FEV1)、日间及夜间哮喘症状评分、咳嗽评分、夜间憋醒天数、使用β2受体激动剂天数。结果:治疗组肺功能各项指标PEFam(356.23±11.32)L/min,PEFpm(334.32±12.34)L/min,FEV1(1.64±0.78)L,FEV1/FVC(87.3±7.76)%;对照组肺功能各项指标PEFam(323.67±10.32)L/min,PEFpm(298.32±11.54)L/min,FEV1(1.23±0.56)L,FEV1/FVC(81.5±7.97)%。治疗组肺功能各项指标改善情况明显优于对照组,两组比较差异均有统计学意义(P<0.05)。并且治疗组日间哮喘症状评分、夜间哮喘症状评分、咳嗽评分、夜间憋醒天数、使用β2受体激动剂天数明显少于对照组,两组比较差异均有统计学意义(P<0.01)。两组患儿均无严重不良反应发生。结论:孟鲁司特能显著改善5～14岁哮喘患儿的肺功能。

Objective： To determine the clinical effect of montelukast, a leukotriene receptor antagonist, in 5 to 14 year old children with asthma. Methods： A total of 84 children patients according to a randomized double-blind control study were divided into two groups. Patients were given montelukast （5 mg chewable tablet） or matching-image placebo once daily at bedtime for 4 weeks. Morning peak expiratory flow rate value （PEFam） , maximum peak flow values in the evening （PEFpm）, first second forced expiratory volume （ FEV1 ） , daytime and nocturnal asthma symptom score, cough score, night hold up days and the course of using beta 2 agonists in two groups were recorded. Results： In the treatment group, lung function indexes such as PEFam （356.23±11.32） L/min, PEFpm （334.32±12.34） L/min, FEV1 （1.64±0.78） L and FEV1/FVC （87.3 ±7.76） % was significantly better than those in the observation group （PEFam （323.67±10.32）L/min, PEFpm （298.32±11.54）L/min, FEV1 （1.23±0.56）L, FEV1/FVC （81.5±7.97）%. The difference was statistically significant （P〈0. 05 ）. The daytime asthma symptom score, nocturnal asthma symptom score, cough score, night hold up days, and the course of using beta 2 agonists in treatment group were significantly lower than those in the control group, there were significant differences （P〈 0.01 ）. Both groups of patients had no severe adverse reaction. Conclusions： Montelukast improves lung function in 5 to 14 year old children with chronic asthma