Combined supplemental oxygen and mandibular advancement device therapy for obstructive sleep apnoea: a randomised controlled trial.

While OSA manifests due to both increased pharyngeal collapsibility and ventilatory control instability, randomised trials targeting both components are lacking.

虽然OSA的发生是由于咽部塌陷性和通气控制不稳定性增加，但针对这两个组成部分的随机试验却很少。

We tested whether combining a ventilatory control intervention (supplemental oxygen) with an upper airway mechanical intervention (mandibular advancement device (MAD)) improves treatment efficacy.

我们测试了结合通气控制干预（补充氧气）与上呼吸道机械干预（下颌前移装置（MAD））是否能提高治疗效果。

Methods

In a multicentre randomised crossover trial, 41 patients with moderate-to-severe OSA (apnoea-hypopnoea index (AHI) >20 events·h-1, scored without desaturation criteria) underwent polysomnography with four single-night interventions: oxygen (4 L·min-1), MAD, combination therapy and sham (air).

在一个多中心随机交叉试验中，41名中度至重度OSA患者（呼吸暂停低通气指数（AHI）>20次/小时，不包括低氧血症标准）接受了四种单夜干预的多导睡眠图监测：氧气（4升/分钟），MAD，联合治疗和安慰剂（空气）。

Primary analysis compared percent change in AHI from baseline between combination therapy and MAD monotherapy.

主要分析比较了从基线开始，组合疗法与MAD单疗法在AHI百分比变化上的差异。

Secondary outcomes included arousal index and visual analogue scale for sleep quality (VASSQ).

次要结果包括觉醒指数和睡眠质量的视觉模拟量表（VASSQ）。

Gold standard baseline pathophysiological traits facilitated mechanistic subgroup analysis.

黄金标准的基线病理生理特征促进了机制性亚组分析。

Results

Of 41 randomised patients (14 females:27 males, median (interquartile range) baseline AHI 49 (29, 62) events·h-1), 38 completed all interventions.

在41名随机患者中（14名女性：27名男性，基线AHI中位数（四分位数间距）为49（29, 62）次·小时-1），有38人完成了所有干预措施。

Compared with sham, AHI was lowered with oxygen (estimate: -33 (95% CI -46, -17)%), MAD (-54 (95% CI -64, -41)%) and the combination (-68 (95% CI -77, -57)%); the combination provided a greater reduction than MAD monotherapy (-14 (95% CI -23, -4)%; p=0.009).

与安慰剂相比，AHI通过氧气(-33 (95% CI -46, -17)%), MAD (-54 (95% CI -64, -41)%)和联合治疗(-68 (95% CI -77, -57)% )均有所降低；联合治疗比MAD单药治疗提供了更大的降低(-14 (95% CI -23, -4)%; p=0.009)。

The combination also improved AHI per 3% desaturation/arousal criteria (-73 (95% CI -81, -62)% versus sham and -17 (95% CI -25, -7)% versus MAD).

联合治疗还根据3%的去饱和/觉醒标准改善了AHI(-73 (95% CI -81, -62)%与安慰剂相比和-17 (95% CI -25, -7)%与MAD相比)。

The combination improved arousal index (-36 (95% CI -43, -27)% versus sham) and VASSQ (+0.98 (95% CI 0.39, 1.58) versus sham), albeit not significantly beyond MAD alone.

联合治疗提高了觉醒指数（-36 (95% CI -43, -27)% 与安慰剂相比）和VASSQ（+0.98 (95% CI 0.39, 1.58) 与安慰剂相比），尽管与MAD单独使用相比没有显著差异。

Effects were greatest in those with higher loop gain and collapsibility.

在具有较高环路增益和可塌陷性的人群中，效果最为显著。

Conclusions

Combining a ventilatory control intervention (supplemental oxygen) with an upper airway intervention (MAD) is a promising approach to markedly attenuate OSA severity beyond that offered by each intervention alone.

将通气控制干预（补充氧气）与上呼吸道干预（MAD）相结合，是一种有前景的方法，可以显著减轻阻塞性睡眠呼吸暂停（OSA）的严重程度，这超出了单独每种干预所提供的效果。