A randomized trial of adenotonsillectomy for childhood sleep apnea.
A randomized trial of adenotonsillectomy for childhood sleep apnea.
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DOI：
10.1056/nejmoa1215881
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发表时间：
2013-06-20
期刊：
影响因子：
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通讯作者：
Childhood Adenotonsillectomy Trial (CHAT)
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作者：
Marcus CL;Moore RH;Rosen CL;Giordani B;Garetz SL;Taylor HG;Mitchell RB;Amin R;Katz ES;Arens R;Paruthi S;Muzumdar H;Gozal D;Thomas NH;Ware J;Beebe D;Snyder K;Elden L;Sprecher RC;Willging P;Jones D;Bent JP;Hoban T;Chervin RD;Ellenberg SS;Redline S;Childhood Adenotonsillectomy Trial (CHAT)
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，但其在减轻症状、改善认知、行为、生活质量和多导睡眠图方面的作用尚未得到严格评价。我们假设，在患有阻塞性睡眠呼吸暂停综合征而没有长期氧合血红蛋白去饱和的儿童中，与支持性护理的观察等待相比，早期腺样体扁桃体切除术将导致改善的结果。我们将464名5 - 9岁患有阻塞性睡眠呼吸暂停综合征的儿童随机分为早期腺样体扁桃体切除术组和观察等待组。在基线和7个月时评估多导睡眠图、认知、行为和健康结果。主要结局的平均基线值，即发育神经心理学评估的注意力和执行功能评分（评分范围为50 - 150，评分越高表示功能越好），接近人群平均值100，从基线到随访的变化在研究组之间没有显著差异。（平均[±SD]改善，早期腺样体切除术组为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方面的改善显著大于观察等待组，并且症状减轻显著大于观察等待组。早期腺样体扁桃体切除术组中多导睡眠图正常化的儿童比例高于观察等待组（79% vs. 46%）。与观察等待策略相比，学龄儿童阻塞性睡眠呼吸暂停综合征的手术治疗并没有显著改善注意力或执行功能（通过神经心理学测试测量），但确实减轻了症状并改善了行为、生活质量和多导睡眠图结果的次要结局，从而为早期腺样体扁桃体切除术的有益效果提供了证据。（由美国国立卫生研究院资助; CHAT ClinicalTrials.gov编号，NCT 00560859。
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.)