孟鲁司特钠对轻度持续哮喘患儿疗效和安全性的随机双盲安慰剂对照试验  

Efficacy and safety of montelukast in children with mild persistent asthma:a randomized double-blind,placebo-controlled trial

作　　者：董文芳[1] 周小建[1] 洪建国[1] 

机构地区：[1]上海交通大学附属第一人民医院,上海201620

出　　处：《中国循证儿科杂志》2011年第4期245-249,共5页Chinese Journal of Evidence Based Pediatrics

摘　　要：目的研究孟鲁司特钠单用于治疗5~14岁轻度持续哮喘患儿的疗效和安全性。方法采用安慰剂随机双盲对照试验,对首诊诊断为轻度持续哮喘患儿,采用调查问卷方式采集患儿基线数据,经过2周安慰剂洗脱期,随机分为治疗组和对照组,分别睡前咀嚼口服孟鲁司特钠或安慰剂5 mg.d-1,疗程均为12周。在入组后4、8和12周记录哮喘日记卡内容：日间和夜间哮喘症状评分、β2受体激动剂使用频率、最大呼气峰流速（PEF）、因哮喘急性发作而需急诊或住院治疗的次数等;于治疗后12周检测肺功能指标：FEV 1%预计值、FEF 25%~75%。结果 2009年9月至2010年9月上海交通大学附属第一人民医院儿科哮喘专科门诊的轻度持续哮喘患儿安慰剂组纳入42例,孟鲁司特钠组纳入89例,至观察终点安慰剂组35例,孟鲁司特钠组77例进入分析。与安慰剂组相比,孟鲁司特钠组的PEF明显改善（P〈0.05）;每周日间和夜间哮喘症状平均评分、每月因哮喘发作而需急诊或住院就诊率和每周平均β2受体激动剂使用次数均下降,差异有显著统计学意义（P〈0.01）;治疗后12周孟鲁司特钠组FEV 1%、FEF 25%~75%较安慰剂组显著提高（P〈0.05）;研究期间两组患儿均未观察到不良反应事件。结论孟鲁司特钠单独用于轻度持续性哮喘患儿具有良好的疗效,不良反应少,患儿依从性高。Objective To study the efficacy and tolerability of montelukast,a leukotriene receptor antagonist,as monotherapy in the treatment of 5 to 14-year-old children with mild persistent bronchial asthma.Methods In this double-blind,randomized,placebo controlled trial,children aged 5-14 years with mild persistent asthma diagnosed using the Childhood Asthma Management Guidelines in China were enrolled.All patients completed the questionnairs to collect baseline data at the first treatment.After a 2-week placebo run-in period,they were enrolled and randomly allocated to placebo or monterlukast sodium groups.Patients received either montelukast（5 mg chewable tablet） or matching-image placebo once daily at bed-time for 12 consecutive weeks.All the patients were assessed at week 4,week 8 and week 12 according to the asthma daily cards,which included following measurements： daytime and nighttime asthma symptom score,short acting beta agonist（SABA） usage,medical resource utilization for asthma and peak expiratory flow rates（PEF）.Spirometry was performed before and after treatment.Side effects were also judged during the 12 weeks of therapy.Results A total of 126 subjects were reruited in the trial,and 112 subjects completed the study,with 35 from the placebo group and 77 from the montelukast sodium group.Compared with placebo group,PEF and lung function were significantly improved after 12 weeks treatment in montelukast group（P0.05）.Daytime and nighttime asthma symptom score,SABA usage and medical resource utilization for asthma were significantly reduced after 12 weeks treatment（P0.01）.Significant clinical improvement（P0.05） was also noted after 4 weeks treatment.No adverse events were observed in the two groups.Conclusions These results suggested that montelukast was an effective and safe controller as monotherapy in children with mild persistent asthma.

关 键 词：儿童 肺功能 轻度持续哮喘 疗效 白三烯受体拮抗剂 孟鲁司特钠 安慰剂 

分 类 号：R725.6[医药卫生—儿科]