舌下神经刺激治疗阻塞性睡眠呼吸暂停的疗效：一项系统评价和荟萃分析。

The outcomes of hypoglossal nerve stimulation in the management of OSA: A systematic review and meta-analysis.

作者信息

Kompelli Anvesh R, Ni Jonathan S, Nguyen Shaun A, Lentsch Eric J, Neskey David M, Meyer Ted A

机构信息

Department of Otolaryngology - Head and Neck Surgery, Medical University of South Carolina, Charleston, SC, USA.

出版信息

World J Otorhinolaryngol Head Neck Surg. 2018 Sep 25;5(1):41-48. doi: 10.1016/j.wjorl.2018.04.006. eCollection 2019 Mar.

OBJECTIVES

Obstructive sleep apnea (OSA) is a prevalent disease with significant health impacts. While first line therapy is CPAP, long-term compliance is low and device misuse is common, highlighting the need for alternative therapies. Upper airway surgery is one alternative, but substantial side effects hamper efficacy. A new alternative is an implantable hypoglossal nerve stimulator (HNS). These devices utilize neuromodulation to dilate/reinforce the airway and reduce side effects associated with traditional surgery. Several recent trials investigated the efficacy of these devices. The purpose of this study was to perform meta-analysis of available HNS studies investigating treatment of OSA to analyze objective and subjective outcomes and side effects.

METHODS

A comprehensive literature search of PubMed and Scopus was performed. Two independent reviewers examined clinical trials investigating HNS in treatment of sleep apnea in adults. Studies with objective and subjective endpoints in sleep were included for analysis. Adverse events from trials were also recorded.

RESULTS

Across 16 studies, 381 patients were analyzed. At 6 months ( = 0.008), mean SAQLI improved by 3.1 (95%, 2.6-3.7). At 12 months ( < 0.0001), mean AHI was reduced by 21.1 (95%, 16.9-25.3), mean ODI was reduced by 15.0 (95%, 12.7-17.4), mean ESS was reduced by 5.0 (95%, 4.2-5.8), mean FOSQ improved by 3.1 (95%, 2.6-3.4). Pain (6.2%:0.7-16.6), tongue abrasion (11.0%:1.2-28.7), and internal (3.0%:0.3-8.4)/external device (5.8%:0.3-17.4) malfunction were common adverse events.

CONCLUSIONS

HNS is a safe and effective treatment for CPAP refractory OSA. Further study comparing HNS to other therapies is required.

目的

阻塞性睡眠呼吸暂停（OSA）是一种普遍存在且对健康有重大影响的疾病。虽然一线治疗方法是持续气道正压通气（CPAP），但长期依从性较低且设备使用不当的情况很常见，这凸显了对替代疗法的需求。上气道手术是一种替代方法，但严重的副作用阻碍了其疗效。一种新的替代方法是植入式舌下神经刺激器（HNS）。这些设备利用神经调节来扩张/加强气道，并减少与传统手术相关的副作用。最近的几项试验研究了这些设备的疗效。本研究的目的是对现有的关于HNS治疗OSA的研究进行荟萃分析，以分析客观和主观结果及副作用。

方法

对PubMed和Scopus进行了全面的文献检索。两名独立的评审员审查了调查HNS治疗成人睡眠呼吸暂停的临床试验。纳入了具有睡眠客观和主观终点的研究进行分析。试验中的不良事件也被记录下来。

结果

在16项研究中，对381名患者进行了分析。在6个月时（P = 0.008），睡眠呼吸暂停生活质量指数（SAQLI）平均提高了3.1（95%置信区间，2.6 - 3.7）。在12个月时（P < 0.0001），平均呼吸暂停低通气指数（AHI）降低了21.1（95%置信区间，16.9 - 25.3），平均氧减指数（ODI）降低了15.0（95%置信区间，12.7 - 17.4），平均Epworth嗜睡量表（ESS）评分降低了5.0（95%置信区间，4.2 - 5.8），功能性口腔睡眠质量量表（FOSQ）平均提高了3.1（95%置信区间，2.6 - 3.4）。疼痛（6.2%：0.7 - 16.6）、舌擦伤（11.0%：1.2 - 28.7）以及内部（3.0%：0.3 - 8.4）/外部设备故障（5.8%：0.3 - 17.4）是常见的不良事件。