Department of Pediatrics, Sleep Center, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, USA.
N Engl J Med. 2013 Jun 20;368(25):2366-76. doi: 10.1056/NEJMoa1215881. Epub 2013 May 21.
Adenotonsillectomy is commonly performed in children with the obstructive sleep apnea syndrome, yet its usefulness in reducing symptoms and improving cognition, behavior, quality of life, and polysomnographic findings has not been rigorously evaluated. We hypothesized that, in children with the obstructive sleep apnea syndrome without prolonged oxyhemoglobin desaturation, early adenotonsillectomy, as compared with watchful waiting with supportive care, would result in improved outcomes.
We randomly assigned 464 children, 5 to 9 years of age, with the obstructive sleep apnea syndrome to early adenotonsillectomy or a strategy of watchful waiting. Polysomnographic, cognitive, behavioral, and health outcomes were assessed at baseline and at 7 months.
The average baseline value for the primary outcome, the attention and executive-function score on the Developmental Neuropsychological Assessment (with scores ranging from 50 to 150 and higher scores indicating better functioning), was close to the population mean of 100, and the change from baseline to follow-up did not differ significantly according to study group (mean [±SD] improvement, 7.1±13.9 in the early-adenotonsillectomy group and 5.1±13.4 in the watchful-waiting group; P=0.16). In contrast, there were significantly greater improvements in behavioral, quality-of-life, and polysomnographic findings and significantly greater reduction in symptoms in the early-adenotonsillectomy group than in the watchful-waiting group. Normalization of polysomnographic findings was observed in a larger proportion of children in the early-adenotonsillectomy group than in the watchful-waiting group (79% vs. 46%).
As compared with a strategy of watchful waiting, surgical treatment for the obstructive sleep apnea syndrome in school-age children did not significantly improve attention or executive function as measured by neuropsychological testing but did reduce symptoms and improve secondary outcomes of behavior, quality of life, and polysomnographic findings, thus providing evidence of beneficial effects of early adenotonsillectomy. (Funded by the National Institutes of Health; CHAT ClinicalTrials.gov number, NCT00560859.).
腺样体扁桃体切除术常用于阻塞性睡眠呼吸暂停综合征患儿，但对于减少症状、改善认知、行为、生活质量和多导睡眠图检查结果的作用尚未经过严格评估。我们假设，对于无血氧饱和度延长下降的阻塞性睡眠呼吸暂停综合征患儿，与观察等待加支持治疗相比，早期腺样体扁桃体切除术将带来更好的结果。
我们将 464 名 5 至 9 岁的阻塞性睡眠呼吸暂停综合征患儿随机分配至早期腺样体扁桃体切除术组或观察等待组。在基线和 7 个月时评估多导睡眠图、认知、行为和健康结局。
主要结局（发育神经心理评估的注意力和执行功能评分，分值为 50 至 150 分，分值越高表示功能越好）的平均基线值接近人群平均值 100，且组间自基线到随访的变化无显著差异（早期腺样体扁桃体切除术组的平均（±SD）改善值为 7.1±13.9，观察等待组为 5.1±13.4；P=0.16）。相比之下，早期腺样体扁桃体切除术组在行为、生活质量和多导睡眠图检查结果方面的改善更显著，症状的减少也更显著。与观察等待组相比，早期腺样体扁桃体切除术组中更多的患儿多导睡眠图检查结果正常化（79%比 46%）。
与观察等待策略相比，对于学龄期儿童阻塞性睡眠呼吸暂停综合征，手术治疗并未显著改善神经心理学测试所测注意力或执行功能，但可减轻症状，改善行为、生活质量和多导睡眠图检查结果的次要结局，从而为早期腺样体扁桃体切除术有益的效果提供了证据。（由美国国立卫生研究院资助；CHAT ClinicalTrials.gov 编号，NCT00560859。）
