Wray Christina M, Thaler Erica R
Perelman School of Medicine, The University of Pennsylvania, Philadelphia, USA.
Department of Otorhinolaryngology - Head and Neck Surgery, The Hospital of Pennsylvania, Philadelphia, USA.
World J Otorhinolaryngol Head Neck Surg. 2016 Dec 22;2(4):230-233. doi: 10.1016/j.wjorl.2016.11.005. eCollection 2016 Dec.
To review the indications and clinical evidence supporting hypoglossal nerve stimulation (HNS) therapy for the treatment of moderate-to-severe obstructive sleep apnea (OSA).
Peer reviewed literature on hypoglossal nerve stimulation therapy for obstructive sleep apnea from 2001 to 2016.
The only currently FDA-approved HNS device for the treatment of moderate-to-severe OSA is produced by Inspire Medical Systems, which recently published its 36-month outcomes data from its Stimulation Therapy for Apnea Reduction (STAR) trial. HNS therapy is currently indicated for moderate-to-severe OSA patients who are CPAP-intolerant, have a body mass index <32, apnea-hypopnea index <50, and without a concentric pattern of upper airway collapse on sleep endoscopy.
Data from the STAR trial suggests that a subset of OSA patients can achieve a significant therapeutic response from hypoglossal nerve stimulation. However, these results may be limited in their generalizability to the broader OSA population.
回顾支持舌下神经刺激(HNS)疗法治疗中重度阻塞性睡眠呼吸暂停(OSA)的适应症及临床证据。
对2001年至2016年期间关于舌下神经刺激疗法治疗阻塞性睡眠呼吸暂停的同行评审文献进行回顾。
目前唯一获得美国食品药品监督管理局(FDA)批准用于治疗中重度OSA的HNS设备由Inspire Medical Systems公司生产,该公司最近公布了其减少呼吸暂停刺激疗法(STAR)试验的36个月结果数据。HNS疗法目前适用于对持续气道正压通气(CPAP)不耐受、体重指数<32、呼吸暂停低通气指数<50且睡眠内镜检查时上气道无同心性塌陷模式的中重度OSA患者。
STAR试验的数据表明,一部分OSA患者可通过舌下神经刺激获得显著的治疗反应。然而,这些结果在推广至更广泛的OSA人群时可能存在局限性。