阻塞性睡眠呼吸暂停儿童行腺样体扁桃体切除术前后吞咽障碍结局：一项随机临床试验的二次分析。
Dysphagia Outcomes Before and After Adenotonsillectomy in Children With Obstructive Sleep Apnea: A Secondary Analysis of a Randomized Clinical Trial.
机构信息
Department of Otolaryngology-Head and Neck Surgery, BenQ Medical Center, School of Medicine, Southeast University, Nanjing, Jiangsu, China.
Department of Otolaryngology-Head and Neck Surgery, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
出版信息
JAMA Otolaryngol Head Neck Surg. 2023 Oct 1;149(10):878-883. doi: 10.1001/jamaoto.2023.2145.
IMPORTANCE
Obstructive sleep apnea (OSA) and tonsil hypertrophy may be associated with dysphagia. However, randomized clinical trials assessing dysphagia outcomes in children randomized to adenotonsillectomy (AT) vs watchful waiting with supportive care (WWSC) are lacking.
OBJECTIVE
To assess dysphagia outcomes in children with OSA and tonsil hypertrophy managed with AT or WWSC.
DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of a multicenter randomized clinical trial, the Childhood Adenotonsillectomy Trial (CHAT), was conducted at tertiary children's hospitals from October 2007 to June 2012. Children aged 5.0 to 9.9 years with OSA were randomized to AT or WWSC and underwent polysomnography at baseline and 7 months. Caregivers completed the OSA-18 questionnaire, which includes an item on difficulty in swallowing at baseline and 7 months. The current secondary analysis was conducted from December 1, 2022, to January 10, 2023.
INTERVENTIONS
AT vs WWSC.
MAIN OUTCOMES AND MEASURES
Prevalence of dysphagia, based on parental responses to the difficulty in swallowing item on the OSA-18 questionnaire, was redefined as a binary outcome at baseline and 7-month follow-up.
RESULTS
In total, 386 children were included (199 female [51.6%]; median [IQR] age, 6.0 [5.0-8.0] years). Of the total, 207 children were Black (53.6%). At baseline, the number of children with dysphagia was similar (4.0%; 95% CI, -4.9% to 12.9%) between the AT group (56 [29.8%]) and the WWSC group (51 [25.8%]). Following AT, a decrease was observed (21.3%; 95% CI, 13.5%-28.9%) in the prevalence of dysphagia among the children. In contrast, the prevalence of dysphagia did not change significantly (1.0%; 95% CI, -7.6% to 9.6%) in the WWSC group. Children in the AT group were more likely to experience a resolution of dysphagia than those in the WWSC group (adjusted odds ratio, 4.84; 95% CI, 1.91-12.25). Higher baseline AHI was associated with a lower resolution of dysphagia (AOR, 0.91; 95% CI, 0.83-0.98).
CONCLUSIONS AND RELEVANCE
This secondary analysis of the CHAT randomized clinical trial suggested that children with dysphagia and OSA undergoing AT may experience dysphagia improvement. A prospective randomized trial that uses a validated dysphagia survey is needed to verify the effectiveness of AT in treating dysphagia.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT00560859.
重要性
阻塞性睡眠呼吸暂停（OSA）和扁桃体肥大可能与吞咽困难有关。然而，缺乏评估接受腺样体扁桃体切除术（AT）与观察等待伴支持性护理（WWSC）的儿童吞咽困难结局的随机临床试验。
目的
评估 OSA 和扁桃体肥大儿童接受 AT 或 WWSC 治疗后的吞咽困难结局。
设计、地点和参与者：这是一项多中心随机临床试验——儿童腺样体扁桃体切除术试验（CHAT）的二次分析，于 2007 年 10 月至 2012 年 6 月在三级儿童医院进行。年龄在 5.0 至 9.9 岁之间的 OSA 儿童被随机分配到 AT 或 WWSC 组，并在基线和 7 个月时进行多导睡眠图检查。护理人员在基线和 7 个月时完成 OSA-18 问卷，该问卷包括一个关于吞咽困难的项目。目前的二次分析于 2023 年 1 月 10 日进行。
干预措施
AT 与 WWSC。
主要结局和测量
基于父母对 OSA-18 问卷中吞咽困难项目的回答，将吞咽困难的患病率重新定义为基线和 7 个月随访时的二项结局。
结果
共纳入 386 名儿童（女性 199 名[51.6%]；中位数[IQR]年龄为 6.0[5.0-8.0]岁）。其中 207 名儿童为黑人（53.6%）。在基线时，AT 组（56 名[29.8%]）和 WWSC 组（51 名[25.8%]）之间的吞咽困难儿童数量相似（4.0%；95%CI，-4.9%至 12.9%）。在 AT 后，吞咽困难的患病率明显下降（21.3%；95%CI，13.5%-28.9%）。相比之下，WWSC 组的吞咽困难患病率无显著变化（1.0%；95%CI，-7.6%至 9.6%）。与 WWSC 组相比，AT 组的儿童更有可能解决吞咽困难（调整后的优势比，4.84；95%CI，1.91-12.25）。较高的基线 AHI 与较低的吞咽困难缓解率相关（AOR，0.91；95%CI，0.83-0.98）。
结论和相关性
本研究对 CHAT 随机临床试验进行了二次分析，结果表明，接受 AT 治疗的伴有吞咽困难的 OSA 儿童可能会改善吞咽困难。需要一项使用验证后的吞咽困难调查的前瞻性随机试验来验证 AT 治疗吞咽困难的有效性。
试验注册
ClinicalTrials.gov 标识符：NCT00560859。
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