Choi Ji H, Cho Jae H, Chung Yoo-Sam, Kim Jeong-Whun, Kim Sung W
Department of Otorhinolaryngology-Head and Neck Surgery, Korea University Ansan Hospital, College of Medicine, Korea University, Ansan, Republic of Korea.
Laryngoscope. 2015 May;125(5):1239-43. doi: 10.1002/lary.24975. Epub 2014 Oct 24.
OBJECTIVES/HYPOTHESIS: The effect of the Pillar implant on mild sleep-disordered breathing (SDB) has been assessed in various studies. However, most of these were conducted among a non-Asian population at a single institution. Therefore, the aim of this study was to prospectively evaluate the efficacy of the Pillar implant in Asian patients with simple snoring and mild obstructive sleep apnea (OSA) at multiple centers.
Multicenter prospective clinical trials.
This study included consecutive subjects with simple snoring or mild OSA. We examined subjective symptoms (snoring intensity, frequency, witnessed apnea, and daytime sleepiness) and objective snoring and respiratory parameters (snoring duration [proportion of sleep while snoring louder than 50 dB], snoring loudness, apnea-hypopnea index, respiratory disturbance index, minimum arterial oxygen saturation, and oxygen desaturation index ≥ 4%) at 3 to 6 months after surgery. Adverse events were also investigated.
Twenty-nine subjects with mild SDB completed the study. Whole group analysis found significant improvements in various subjective symptoms, but not in the objective snoring and respiratory parameters. A subgroup analysis of subjects with mild OSA (n = 11) found significant alleviation in various subjective symptoms, apnea-hypopnea index, respiratory disturbance index, and oxygen desaturation index ≥ 4%. No major complication related to surgery was observed, and most minor adverse effects were resolved without morbidity.
In selected Korean patients, the Pillar implant significantly improved not only subjective symptoms of mild SDB but also respiratory disturbances in mild OSA.
2b.
目的/假设:在各项研究中已对Pillar植入物治疗轻度睡眠呼吸障碍(SDB)的效果进行了评估。然而,其中大多数研究是在单一机构的非亚洲人群中开展的。因此,本研究的目的是在多个中心对Pillar植入物治疗亚洲单纯打鼾和轻度阻塞性睡眠呼吸暂停(OSA)患者的疗效进行前瞻性评估。
多中心前瞻性临床试验。
本研究纳入连续的单纯打鼾或轻度OSA患者。我们在术后3至6个月检查了主观症状(打鼾强度、频率、目击性呼吸暂停和日间嗜睡)以及客观打鼾和呼吸参数(打鼾持续时间[打鼾声大于50分贝时的睡眠时间比例]、打鼾响度、呼吸暂停低通气指数、呼吸紊乱指数、最低动脉血氧饱和度和氧去饱和指数≥4%)。还对不良事件进行了调查。
29名轻度SDB患者完成了研究。全组分析发现各种主观症状有显著改善,但客观打鼾和呼吸参数无改善。对轻度OSA患者(n = 11)的亚组分析发现各种主观症状、呼吸暂停低通气指数、呼吸紊乱指数和氧去饱和指数≥4%有显著缓解。未观察到与手术相关的重大并发症,大多数轻微不良反应无需治疗即可缓解。
在选定的韩国患者中,Pillar植入物不仅显著改善了轻度SDB的主观症状,还改善了轻度OSA的呼吸紊乱。
2b。