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采用 SMOOTH 模式的非侵入性 Er:YAG 激光治疗打鼾:一项随机对照试验。

Treatment of snoring using a non-invasive Er:YAG laser with SMOOTH mode (NightLase): a randomized controlled trial.

机构信息

ENT, Praxis für Ästhetik/HNO, Ludwigstrasse 7, Augsburg, Bavaria, Germany.

ENT, MVZ Moser Gehrking Sauter und Partner, Augsburg, Bavaria, Germany.

出版信息

Eur Arch Otorhinolaryngol. 2023 Jan;280(1):307-312. doi: 10.1007/s00405-022-07539-9. Epub 2022 Jul 22.

Abstract

OBJECTIVES

The aim of this study was to assess safety and efficacy of a non-invasive 2940 nm Er:YAG treatment with SMOOTH mode in reducing snoring in adult patients and to compare its efficacy and safety to sham treatment in a randomized controlled trial setting.  METHODS: 40 primary snoring patients (≥ 18 year, AHI < 15e/h, BMI ≤ 30) were randomized to receive either 3 sessions NightLase or sham laser treatment. The main outcome measures were Snore Outcomes Survey (SOS), the Spouse/Bed Partner Survey (SBPS), a visual analogue snoring scale (bed partner) and a visual analogue pain scale.

RESULTS

NightLase was well tolerated, no local anaesthesia was required (mean VAS pain score in NightLase group = 3.0 ± 1.7). No complications occurred. SOS, SBPS and VAS snoring scores improved in the NightLase group (33.7 ± 14.1 to 56.2 ± 16.1) (35.0 ± 17.1 to 61.5 ± 16.4) and (7.9 ± 2.0 to 4.7 ± 2.8) while no changing in the sham group (32.2 ± 14.5 vs 32.1 ± 13.0) (36.7 ± 12.1 vs 34.7 ± 12.7) (8.1 ± 1.7 vs 8.0 ± 1.6), respectively.

CONCLUSIONS

NightLase is a safe, minimal invasive treatment that significantly reduced snoring compared to sham treatment.

摘要

目的

本研究旨在评估非侵入性 2940nmEr:YAG 治疗(SMOOTH 模式)在减少成人患者打鼾中的安全性和有效性,并在随机对照试验中比较其疗效和安全性与假治疗。

方法

40 例原发性打鼾患者(年龄≥18 岁,AHI<15e/h,BMI≤30)随机分为接受 3 次 NightLase 或假激光治疗。主要结局指标为鼾症结局调查(SOS)、配偶/床伴调查(SBPS)、视觉模拟打鼾量表(床伴)和视觉模拟疼痛量表。

结果

NightLase 耐受性良好,无需局部麻醉(NightLase 组平均 VAS 疼痛评分=3.0±1.7)。无并发症发生。SOS、SBPS 和 VAS 打鼾评分在 NightLase 组改善(33.7±14.1 至 56.2±16.1)(35.0±17.1 至 61.5±16.4)和(7.9±2.0 至 4.7±2.8),而假治疗组无变化(32.2±14.5 与 32.1±13.0)(36.7±12.1 与 34.7±12.7)(8.1±1.7 与 8.0±1.6)。

结论

NightLase 是一种安全、微创的治疗方法,与假治疗相比,能显著减轻打鼾。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2303/9813098/424e5c758a45/405_2022_7539_Fig1_HTML.jpg

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