Section of Pediatric Sleep Medicine, Department of Pediatrics, Biological Sciences Division, Pritzker School of Medicine, University of Chicago, Chicago, Illinois.
Ann Am Thorac Soc. 2016 Oct;13(10):1736-1741. doi: 10.1513/AnnalsATS.201606-432OC.
Obstructive sleep apnea (OSA) is highly prevalent in children and is usually treated by adenotonsillectomy. Nonsurgical therapies for OSA consist primarily of antiinflammatory approaches and have gained popularity, but their efficacy remains to be critically examined.
To determine the effect of montelukast on pediatric OSA.
A prospective randomized double-blind controlled trial of polysomnographically diagnosed OSA in children ages 2-10 years who were treated with either oral montelukast (4 or 5 mg daily) or placebo for 16 weeks. Adherence to the medication was ascertained using automated timed pill dispensers along with weekly telephonic reminders.
Ninety-two children diagnosed with OSA were approached, and 64 (69.6%) agreed to participate. Of these, 57 (89.0%) completed the 16-week trial, 28 in the montelukast group and 29 in the placebo group. Age, sex, and percentage of obesity were similar in the two groups, as were initial apnea-hypopnea index (AHI) scores. Overall, intention-to-treat analyses revealed that beneficial effects occurred in 20 children receiving montelukast (71.4%), whereas only 2 (6.9%) of the children receiving placebo showed reductions in AHI score (P < 0.001). Indeed, AHI decreased from 9.2 ± 4.1/hour total sleep time (TST) to 4.2 ± 2.8/hour TST (P < 0.0001) in montelukast-treated children, whereas in children receiving placebo, the AHI did not change (from 8.2 ± 5.0/h TST before to 8.7 ± 4.9/h TST at completion of the trial).
When compared with placebo, montelukast for 16 weeks effectively reduced the severity of obstructive sleep apnea in children 2-10 years of age. These results support a therapeutic role for leukotriene modifiers in pediatric OSA provided that long-term trials confirm current findings. Clinical trial registered with www.clinicaltrials.gov (NCT 00599534).
阻塞性睡眠呼吸暂停（OSA）在儿童中非常普遍，通常通过腺样体扁桃体切除术进行治疗。OSA 的非手术治疗主要包括抗炎方法，并且已经越来越受欢迎，但它们的疗效仍需要严格审查。
确定孟鲁司特对儿科 OSA 的影响。
对 2-10 岁经多导睡眠图诊断为 OSA 的儿童进行前瞻性随机双盲对照试验，这些儿童接受口服孟鲁司特（4 或 5mg 每日）或安慰剂治疗 16 周。通过自动定时药丸分配器和每周电话提醒来确定药物的依从性。
共接触了 92 名患有 OSA 的儿童，其中 64 名（69.6%）同意参加。其中，57 名（89.0%）完成了 16 周的试验，28 名在孟鲁司特组，29 名在安慰剂组。两组的年龄、性别和肥胖百分比相似，初始呼吸暂停低通气指数（AHI）评分也相似。总体而言，意向治疗分析显示，20 名接受孟鲁司特治疗的儿童（71.4%）出现了有益的效果，而接受安慰剂治疗的儿童中仅有 2 名（6.9%）的 AHI 评分降低（P < 0.001）。事实上，孟鲁司特治疗组的 AHI 从 9.2±4.1 小时总睡眠时间（TST）/小时降至 4.2±2.8 小时 TST/小时（P < 0.0001），而安慰剂组的 AHI 没有变化（从试验前的 8.2±5.0 小时 TST/小时增加到试验完成时的 8.7±4.9 小时 TST/小时）。
与安慰剂相比，孟鲁司特治疗 16 周可有效降低 2-10 岁儿童阻塞性睡眠呼吸暂停的严重程度。这些结果支持在儿科 OSA 中使用白三烯调节剂进行治疗，如果长期试验证实目前的发现，那么这些结果将具有治疗意义。该临床试验已在 www.clinicaltrials.gov 注册（NCT 00599534）。
