孟鲁司特治疗毛细支气管炎的随机对照研究
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摘要
目的:本研究假设孟鲁司特可以改善毛细支气管炎的临床症状及继发的气道高反应性病变。方法:自2007年11月~2008年3月期间在新疆医科大学第一附属医院儿科、乌市儿童医院儿科、军区总医院儿科入院且符合纳入标准的400例毛细支气管炎患儿,随机分为四组,分别给予常规治疗(对照组)、常规治疗加布地奈德吸入7天(布地奈德组)、常规治疗加孟鲁司特口服7天(孟鲁司特短程组)及28天(孟鲁司特长程组),观察各组临床疗效、平均住院日、总IgE水平、ECP的变化,并随访1~1.5年,统计毛支后反复喘息次数及哮喘发生率。结果:各组基线具有可比性。四组间在住院天数、症状评分改善上无统计学差异,两两比较也无统计学差异;布地奈德组与对照组在总IgE、ECP水平变化上、日后喘息反复发作次数、哮喘发生率上无统计学差异。孟鲁司特短程组、孟鲁司特长程组与对照组、布地奈德组之间,孟鲁司特短、长程组之间在以上指标上有统计学差异。结论:未发现吸入布地奈德7天能够改善毛支急性期及毛支后继发的气道反应性病变,孟鲁司特不能减轻毛细支气管炎的急性期症状,但可改善毛支后继发的气道高反应性病变,即减少日后反复喘息次数,降低毛支后哮喘发生率,且长疗程组优于短疗程组。
Objectives: We hypothesized that montelukast would ameliorate clinical symptom and reactive airway disease subsequent to bronchiolitis. Methods: Four hundreds infants who were 3 to 24 months old, hospitalized with acute bronchiolitis in three hospitals from November,2007 to March,2008,inluding The First Teaching Hospital of Xinjiang Medical University、A Urumchi Pediatric Hospital Branch、The Military General Hospital of Xinjiang PLA, were randomly assigned into four groups : conventional group、to add Budesonide、to add Montelukast for 7 days and 28 days .The primary outcomes were bronchial hyperresponsiveness (BHR)after treatment including recurrent post-bronchiolitis wheezing and asthma formation rate.The secondary end points were each group’s therapeutic efficacy、average hosp day、changes in serum IgE level、eosinophilic cationic protein (ECP). Results:Both groups were comparable at baseline.No significant differences were seen between four groups in therapeutic efficacy and average hosp day; No significant differences were seen between Control group and Budesonide group in changes in IgE、ECP、recurrent post-bronchiolitis wheezing and asthma formation rate. Compared to Control group and Budesonide group, there were significantly differences after treatment with montelukast of short and long course group in IgE、ECP、recurrent post-bronchiolitis wheezing and asthma formation rate,and within-group of Montelukast has significant differences.Conclusion: We cannot take a conclusion that Budesonide for 7 days can improve respiratory acute symptoms and post-bronchiolitis hyperreactivity. Montelukast did not improve the clinical course in acute bronchiolitis.But it could ameliorate reactive airway disease subsequent to bronchiolitis,decrease the recurrent post-bronchiolitis wheezing and asthma formation rate, and there are different effect between montelukast of short and long course group,Long course group was better than short course group.
引文
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