Petri Niels, Svanholt Palle, Solow Beni, Wildschiødtz Gordon, Winkel Per
ENT Department, Nykoebing F. Hospital, Region Zealand, Nykoebing F., Denmark.
J Sleep Res. 2008 Jun;17(2):221-9. doi: 10.1111/j.1365-2869.2008.00645.x.
The aim of this trial was to evaluate the efficacy of a mandibular advancement appliance (MAA) for obstructive sleep apnoea (OSA). Ninety-three patients with OSA and a mean apnoea-hypopnoea index (AHI) of 34.7 were centrally randomised into three, parallel groups: (a) MAA; (b) mandibular non-advancement appliance (MNA); and (c) no intervention. The appliances were custom made, in one piece. The MAAs had a mean protrusion of the mandible of 74% (range 64-85%). Outcome measures, assessed after continuous use for 4 weeks, were AHI (polysomnography), daytime sleepiness (Epworth) and quality of life (SF-36). Eighty-one patients (87%) completed the trial. The MAA group achieved mean AHI and Epworth scores significantly lower (P < 0.001 and P < 0.05) than the MNA group and the no-intervention group. No significant differences were found between the MNA group and the no-intervention group. The MAA group had a mean AHI reduction of 14.1 (95% CI 7.4-20.8), and a mean Epworth score reduction of 3.3 (95% CI 1.8-4.8). Eight MAA patients (30%) achieved a reduction in AHI > or = 75% ending with an AHI < 5, half of them having baseline AHI > 30. Sensitivity analyses confirmed these results. MAA had a significant beneficial effect on the vitality domain of SF-36. Four MAA patients (14.8%) and two MNA patients (8%) discontinued interventions because of adverse effects. Our conclusion is that MAA has significant beneficial effects on OSA, including cure in some cases of severe OSA. Protrusion of the mandible is essential for the effect. MNA has no placebo effect. MAA may be a good alternative to CPAP in subsets of OSA patients.
本试验的目的是评估下颌前移矫治器（MAA）治疗阻塞性睡眠呼吸暂停（OSA）的疗效。93例OSA患者，平均呼吸暂停低通气指数（AHI）为34.7，被集中随机分为三组平行组：（a）MAA组；（b）下颌非前移矫治器（MNA）组；（c）无干预组。矫治器均为定制的一体式。MAA组下颌平均前突74%（范围64%-85%）。连续使用4周后评估的结果指标包括AHI（多导睡眠图）、日间嗜睡（Epworth量表）和生活质量（SF-36量表）。81例患者（87%）完成了试验。MAA组的平均AHI和Epworth评分显著低于MNA组和无干预组（P<0.001和P<0.05）。MNA组和无干预组之间未发现显著差异。MAA组平均AHI降低14.1（95%可信区间7.4-20.8），平均Epworth评分降低3.3（95%可信区间1.8-4.8）。8例MAA组患者（30%）的AHI降低≥75%，最终AHI<5，其中一半患者基线AHI>30。敏感性分析证实了这些结果。MAA对SF-36量表的活力领域有显著有益影响。4例MAA组患者（14.8%）和2例MNA组患者（8%）因不良反应停止干预。我们的结论是，MAA对OSA有显著有益影响，包括在一些重度OSA病例中可治愈。下颌前突对该疗效至关重要。MNA没有安慰剂效应。在部分OSA患者亚组中，MAA可能是持续气道正压通气（CPAP）的良好替代方案。
