Department of Paediatrics, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong Special administrative region of China; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong Special administrative region of China; Laboratory for Paediatric Respiratory Research, Li Ka Shing Institute of Health Sciences, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong Special administrative region of China; Translational Medicine, Research Institute, The Hospital for Sick Children, Toronto, Ontario, Canada.
Department of Paediatrics, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong Special administrative region of China; Hong Kong Hub of Paediatric Excellence, The Chinese University of Hong Kong, Hong Kong Special administrative region of China; Laboratory for Paediatric Respiratory Research, Li Ka Shing Institute of Health Sciences, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong Special administrative region of China.
Sleep Med. 2023 Jul;107:9-17. doi: 10.1016/j.sleep.2023.04.006. Epub 2023 Apr 11.
To investigate the effect of surgical intervention on 24-h ABP in children with OSA. It was hypothesized that blood pressure would improve following adenotonsillectomy.
This was a two-centered investigator-blinded randomized controlled trial. Non-obese pre-pubertal children aged 6-11 years with OSA (obstructive apnea-hypopnea index, OAHI >3/h) underwent 24-h ABP monitoring at baseline and 9 months after the randomly assigned intervention, i.e. Early Surgery (ES) or Watchful Waiting (WW). Intention-to-treat analysis was performed.
137 subjects were randomized. Sixty-two (Age: 7.9y ± 1.3, 71% boys) and 47 (Age: 8.5y ± 1.6, 77% boys) participants from the ES and WW groups, respectively completed the study. Changes in ABP parameters were similar in the ES and WW groups (nighttime systolic BP z-scores: +0.03 ± 0.93 vs. -0.06 ± 1.04, p = 0.65; nighttime diastolic BP z-scores: -0.20 ± 0.95 vs. -0.02 ± 1.00, p = 0.35) despite a greater improvement in OSA in the ES group. However, a reduction in nighttime diastolic BP z-score correlated with improvements in OSA severity indexes (r = 0.21-0.22, p < 0.05), and a significant improvement in nighttime diastolic BP z-score [-0.43 ± 1.01, p = 0.027] following surgery was observed in participants with severe preoperative OSA (OAHI ≥10/h). The ES group had a significant increase in body mass index z-score after surgery [+0.27 ± 0.57, p < 0.001], which correlated with the increase in daytime systolic BP z-score (r = 0.2, p < 0.05).
Surgical treatment did not lead to significant improvements in ABP in OSA children except in those with more severe disease. The improvement in BP was partially masked by the weight gain following surgery.
The trial was registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn.
ChiCTR-TRC-14004131).
探讨手术干预对 OSA 儿童 24 小时 ABp 的影响。假设血压会在扁桃体腺样体切除术（adenotonsillectomy）后改善。
这是一项双中心、研究者盲法、随机对照试验。非肥胖、青春期前、年龄在 6-11 岁、阻塞性睡眠呼吸暂停低通气指数（obstructive apnea-hypopnea index，OAHI）＞3/h 的 OSA 儿童进行 24 小时 ABp 监测，在基线和随机分配干预后 9 个月，即早期手术（ES）或观察等待（WW）。采用意向治疗分析。
共纳入 137 名受试者，62 名（年龄：7.9y ± 1.3，71%为男性）和 47 名（年龄：8.5y ± 1.6，77%为男性）分别来自 ES 和 WW 组的参与者完成了研究。尽管 ES 组 OSA 改善程度更大，但 ES 组和 WW 组 ABp 参数的变化相似（夜间收缩压 z 评分：+0.03 ± 0.93 与-0.06 ± 1.04，p=0.65；夜间舒张压 z 评分：-0.20 ± 0.95 与-0.02 ± 1.00，p=0.35）。然而，夜间舒张压 z 评分的降低与 OSA 严重程度指标的改善相关（r=0.21-0.22，p＜0.05），并且在术前 OSA 严重（OAHI≥10/h）的参与者中观察到手术后夜间舒张压 z 评分的显著改善[-0.43 ± 1.01，p=0.027]。ES 组手术后体重指数 z 评分显著升高[+0.27 ± 0.57，p＜0.001]，与日间收缩压 z 评分的升高相关（r=0.2，p＜0.05）。
除了那些疾病更严重的患者外，手术治疗并没有导致 OSA 儿童 ABp 的显著改善。手术后体重增加部分掩盖了血压的改善。
该试验在中国临床试验注册中心（http://www.chictr.org.cn）注册。注册号：ChiCTR-TRC-14004131。
