UAHS Center for Sleep & Circadian Sciences, University of Arizona, Tucson, Arizona.
Department of Pediatrics, University of Arizona, Tucson, Arizona.
J Clin Sleep Med. 2023 Dec 1;19(12):2065-2073. doi: 10.5664/jcsm.10764.
Children with Down syndrome (DS) are at very high risk for obstructive sleep apnea (OSA). Current OSA treatments have limited effectiveness in this population. We evaluated the effectiveness of atomoxetine and oxybutynin (ato-oxy) to treat OSA in children with Down syndrome.
Children ages 6-7 years old with Down syndrome and OSA participated in a double-blind crossover clinical trial evaluating two dose regimens of ato-oxy. Participants received low-dose ato-oxy (0.5 mg/kg atomoxetine and 5 mg oxybutynin) and high-dose ato-oxy (1.2 mg/kg atomoxetine and 5 mg oxybutynin) for 1 month in random order. The primary study outcome was change in obstructive apnea-hypopnea index. Health-related quality of life as measured by the OSA-18 as well as changes in sleep architecture were secondary outcomes.
Fifteen participants qualified for randomization and 11 participants had complete data at all points. Baseline obstructive apnea-hypopnea index was 7.4 ± 3.7 (mean ± standard deviation), obstructive apnea-hypopnea index with low-dose ato-oxy was 3.6 ± 3.3 ( = .001 vs baseline), and obstructive apnea-hypopnea index with high-dose ato-oxy was 3.9 ± 2.8 ( = .003 vs baseline). No significant sleep architecture differences were present with ato-oxy. No significant difference in OSA-18 score was present. OSA-18 total score was 51 ± 19 at baseline, 45 ± 17 ( = .09) at the end of 4 weeks of low-dose ato-oxy, and 45 ± 16 ( = .37) at the end of high-dose ato-oxy therapy. The most common adverse effects were irritability and fatigue, and these were generally mild.
Ato-oxy is a promising treatment for OSA in children with Down syndrome.
Registry: Clinicaltrials.gov; Name: Medications for Obstructive Sleep Apnea In Children With Down Syndrome (MOSAIC); URL: https://clinicaltrials.gov/ct2/show/NCT04115878; Identifier: NCT04115878.
Combs D, Edgin J, Hsu C-H, et al. The combination of atomoxetine and oxybutynin for the treatment of obstructive sleep apnea in children with Down syndrome. . 2023;19(12):2065-2073.
唐氏综合征（DS）患儿患阻塞性睡眠呼吸暂停（OSA）的风险极高。目前针对该人群的 OSA 治疗方法效果有限。我们评估了阿托西汀和奥昔布宁（阿托-奥昔）治疗唐氏综合征患儿 OSA 的效果。
6-7 岁患有 OSA 的唐氏综合征患儿参与了一项双盲交叉临床试验，以评估两种阿托-奥昔剂量方案。参与者以随机顺序接受低剂量阿托-奥昔（0.5mg/kg 阿托西汀和 5mg 奥昔布宁）和高剂量阿托-奥昔（1.2mg/kg 阿托西汀和 5mg 奥昔布宁）治疗 1 个月。主要研究结果是阻塞性呼吸暂停低通气指数的变化。以 OSA-18 测量的健康相关生活质量以及睡眠结构变化为次要结果。
15 名参与者符合随机分组条件，11 名参与者在所有时间点均有完整数据。基线阻塞性呼吸暂停低通气指数为 7.4±3.7（平均值±标准差），低剂量阿托-奥昔组为 3.6±3.3（ =.001 与基线相比），高剂量阿托-奥昔组为 3.9±2.8（ =.003 与基线相比）。阿托-奥昔治疗后睡眠结构无明显差异。OSA-18 评分无显著差异。OSA-18 总分基线时为 51±19，低剂量阿托-奥昔治疗 4 周结束时为 45±17（ =.09），高剂量阿托-奥昔治疗结束时为 45±16（ =.37）。最常见的不良反应是易怒和疲劳，这些反应通常较轻。
阿托西汀联合奥昔布宁是治疗唐氏综合征儿童 OSA 的一种很有前途的方法。
注册处：Clinicaltrials.gov；名称：治疗唐氏综合征儿童阻塞性睡眠呼吸暂停的药物（MOSAIC）；网址：https://clinicaltrials.gov/ct2/show/NCT04115878；标识符：NCT04115878。
Combs D, Edgin J, Hsu C-H, et al. 阿托西汀联合奥昔布宁治疗唐氏综合征儿童阻塞性睡眠呼吸暂停。. 2023;19(12):2065-2073.
