澳大利亚伊拉瓦拉耳鼻喉头颈诊所Stuart MacKay团队比较了多级上气道手术与药物治疗对常规治疗失败的中重度阻塞性睡眠呼吸暂停患者的疗效。2020年9月4日，该研究发表在《美国医学会杂志》上。

许多成人阻塞性睡眠呼吸暂停（OSA）使用器械治疗不充分，患者未治愈。

为了评估腭舌联合手术扩大或稳定上呼吸道是否对传统器械治疗失败的OSA患者有效，研究组进行了一项多中心、平行组、开放标签、随机临床试验，2014年8月至2017年11月，招募了102例常规治疗失败的有症状的中重度OSA患者。

将患者随机分组，其中51例接受多级手术，即改良悬雍垂腭咽成形术和微创减舌术；51例接受持续的医疗管理，例如建议改善睡眠姿势、减肥等。主要观察指标为呼吸暂停低通气指数（AHI，15-30为中度、>30为重度OSA）和Epworth嗜睡量表（ESS，>10表示病理性嗜睡）。

102名参与者的平均年龄为44.6岁，18%为女性，89%完成了试验。手术组基线时平均AHI为47.9，6个月时为20.8；医疗管理组基线时平均AHI为45.3，6个月时为34.5，组间差异显著。手术组基线时平均ESS评分为12.4，6个月时为5.3；医疗管理组基线时平均ESS为11.1，6个月时为10.5，组间差异显著。手术组有2名患者（4%）出现严重不良事件，1人在术后第5天发生心肌梗死，1人因呕血而住院观察。

研究结果表明，对于常规治疗失败的中重度阻塞性睡眠呼吸暂停的成人，腭舌联合手术与药物治疗相比，可有效减少6个月时的呼吸暂停和低呼吸事件以及患者自述的嗜睡症状。

附：英文原文

Title: Effect of Multilevel Upper Airway Surgery vs Medical Management on the Apnea-Hypopnea Index and Patient-Reported Daytime Sleepiness Among Patients With Moderate or Severe Obstructive Sleep Apnea: The SAMS Randomized Clinical Trial

Author: Stuart MacKay, A. Simon Carney, Peter G. Catcheside, Ching Li Chai-Coetzer, Michael Chia, Peter A. Cistulli, John-Charles Hodge, Andrew Jones, Billingsley Kaambwa, Richard Lewis, Eng H. Ooi, Alison J. Pinczel, Nigel McArdle, Guy Rees, Bhajan Singh, Nicholas Stow, Edward M. Weaver, Richard J. Woodman, Charmaine M. Woods, Aeneas Yeo, R. Doug McEvoy

Issue&Volume: 2020-09-04

Abstract:

Importance  Many adults with obstructive sleep apnea (OSA) use device treatments inadequately and remain untreated.

Objective  To determine whether combined palatal and tongue surgery to enlarge or stabilize the upper airway is an effective treatment for patients with OSA when conventional device treatment failed.

Design, Setting, and Participants  Multicenter, parallel-group, open-label randomized clinical trial of upper airway surgery vs ongoing medical management. Adults with symptomatic moderate or severe OSA in whom conventional treatments had failed were enrolled from August 2014 to November 2017, with follow-up until August 2018.

Interventions  Multilevel surgery (modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction; n=51) or ongoing medical management (eg, advice on sleep positioning, weight loss; n=51).

Main Outcomes and Measures  Primary outcome measures were the apnea-hypopnea index (AHI; ie, the number of apnea and hypopnea events/h; 15-30 indicates moderate and >30 indicates severe OSA) and the Epworth Sleepiness Scale (ESS; range, 0-24; >10 indicates pathological sleepiness). Baseline-adjusted differences between groups at 6 months were assessed. Minimal clinically important differences are 15 events per hour for AHI and 2 units for ESS.

Results  Among 102 participants who were randomized (mean [SD] age, 44.6 [12.8] years; 18 [18%] women), 91 (89%) completed the trial. The mean AHI was 47.9 at baseline and 20.8 at 6 months for the surgery group and 45.3 at baseline and 34.5 at 6 months for the medical management group (mean baseline-adjusted between-group difference at 6 mo, 17.6 events/h [95% CI, 26.8 to 8.4]; P<.001). The mean ESS was 12.4 at baseline and 5.3 at 6 months in the surgery group and 11.1 at baseline and 10.5 at 6 months in the medical management group (mean baseline-adjusted between-group difference at 6 mo, 6.7 [95% CI, 8.2 to 5.2]; P<.001). Two participants (4%) in the surgery group had serious adverse events (1 had a myocardial infarction on postoperative day 5 and 1 was hospitalized for observation following hematemesis of old blood).

Conclusions and Relevance  In this preliminary study of adults with moderate or severe OSA in whom conventional therapy had failed, combined palatal and tongue surgery, compared with medical management, reduced the number of apnea and hypopnea events and patient-reported sleepiness at 6 months. Further research is needed to confirm these findings in additional populations and to understand clinical utility, long-term efficacy, and safety of multilevel upper airway surgery for treatment of patients with OSA.

DOI: 10.1001/jama.2020.14265

Source: https://jamanetwork.com/journals/jama/fullarticle/2770361