Montelukast for Children With Obstructive Sleep Apnea: A Double-blind, Placebo-Controlled Study

Montelukast for Children With Obstructive Sleep Apnea: A Double-blind, Placebo-Controlled Study
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DOI:
10.1542/peds.2012-0310
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发表时间:
2012-09-01
期刊:
影响因子:
8
通讯作者:
Tal, Asher
Tal, Asher
中科院分区:
医学2区
文献类型:
--
作者:
Goldbart, Aviv D.;Greenberg-Dotan, Sari;Tal, Asher

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目的:患有非严重阻塞性睡眠呼吸暂停 (OSA) 的儿童受益于白三烯调节剂等替代治疗干预措施。我们假设孟鲁司特可能改善儿童的 OSA。我们以双盲、随机、安慰剂对照的方式测试了这一假设。方法:在 50 名可能的候选者中,我们招募了 46 名经多导睡眠图诊断患有 OSA 的儿童。在这项前瞻性、双盲、随机试验中,儿童每天口服 4 毫克或 5 毫克孟鲁司特(分别为 6 岁)或安慰剂,持续 12 周。治疗前后进行多导睡眠图评估、家长问卷调查和评估腺样体大小的 X 光检查。 结果:与接受安慰剂的 23 名儿童相比,接受孟鲁司特治疗的 23 名儿童在呼吸障碍(阻塞性呼吸暂停指数)、儿童症状和腺样体大小的多导睡眠图测量方面显示出显着改善。 65.2% 的接受治疗的儿童的阻塞性呼吸暂停指数下降了 50% 以上。没有发生减员或副作用。结论:每日口服孟鲁司特的 12 周治疗有效降低了非重度 OSA 儿童 OSA 的严重程度和潜在腺样体肥大的程度。儿科 2012;130:e575-e580
OBJECTIVES: Children with nonsevere obstructive sleep apnea (OSA) benefit from alternative therapeutic interventions such as leukotriene modifiers. We hypothesized that montelukast might improve OSA in children. We tested this hypothesis in a double-blind, randomized, placebo-controlled fashion.METHODS: Of 50 possible candidates, we recruited 46 children with polysomnographically diagnosed OSA. In this prospective, double-blind, randomized trial, children received daily oral montelukast at 4 or 5 mg (6 years of age, respectively) or placebo for 12 weeks. Polysomnographic assessments, parent questionnaires, and radiographs to assess adenoid size were performed before and after therapy.RESULTS: Compared with the 23 children that received placebo, the 23 children that received montelukast showed significant improvements in polysomnographic measures of respiratory disturbance (obstructive apnea index), children's symptoms, and adenoid size. The obstructive apnea index decreased by >50% in 65.2% of treated children. No attrition or side effects occurred.CONCLUSIONS: A 12-week treatment with daily, oral montelukast effectively reduced the severity of OSA and the magnitude of the underlying adenoidal hypertrophy in children with nonsevere OSA. Pediatrics 2012;130:e575-e580