下颌前移装置治疗阻塞性睡眠呼吸暂停：ORCADES 研究 5 年随访数据。
Mandibular advancement device use in obstructive sleep apnea: ORCADES study 5-year follow-up data.
机构信息
AP-HP, Hôpital Hôtel Dieu, Centre du Sommeil et de la Vigilance, Paris, France.
Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
出版信息
J Clin Sleep Med. 2021 Aug 1;17(8):1695-1705. doi: 10.5664/jcsm.9308.
STUDY OBJECTIVES
Mandibular advancement devices (MADs) are an alternative to continuous positive airway pressure for the management of obstructive sleep apnea (OSA). The ORthèse d'avanCée mAndibulaire dans le traitement en DEuxième intention du SAHOS sévère (ORCADES) study is investigating the long-term effectiveness of MAD therapy in patients with OSA who refused or were intolerant of continuous positive airway pressure. Five-year follow-up data are presented.
METHODS
Data were available in 172 of 331 patients treated with a custom-made computer-aided design/computer-aided manufacturing biblock MAD (Narval CC; ResMed, Saint-Priest, France). The primary end point was treatment success (≥50% decrease in apnea-hypopnea index from baseline).
RESULTS
Five-year treatment success rates were 52% overall and 25%, 52%, and 63%, respectively, in patients with mild, moderate, or severe OSA. This reflects a decline over time vs 3-6 months (79% overall) and 2 years (68%). Rates declined in all patient subgroups but to the greatest extent in patients with mild OSA. The slight worsening of respiratory parameters over time was not associated with any relevant changes in sleepiness and symptoms. Moderate or severe OSA at baseline, treatment success at 3-6 months, and no previous continuous positive airway pressure use were significant independent predictors of 5-year treatment success on multivariate analysis. No new safety signals emerged during long-term follow-up. The proportion of patients using their MAD for ≥4 h/night on ≥4 days/wk was 93.3%; 91.3% of patients reported device use of ≥6 h/night at 5 years. At 5-year follow-up, 96.5% of patients reported that they wanted to continue MAD therapy.
CONCLUSIONS
Long-term MAD therapy remained effective after 5 years in >50% of patients, with good levels of patient satisfaction and adherence.
CITATION
Vecchierini MF, Attali V, Collet JM, et al. Mandibular advancement device use in obstructive sleep apnea: ORCADES study 5-year follow-up data. . 2021;17(8):1695-1705.
研究目的
下颌前移装置（MAD）是治疗阻塞性睡眠呼吸暂停（OSA）的一种替代持续气道正压通气（CPAP）的方法。ORthèse d'avanCée mAndibulaire dans le traitement en DEuxième intention du SAHOS sévère（ORCADES）研究正在调查拒绝或不能耐受 CPAP 的 OSA 患者中 MAD 治疗的长期疗效。本文报告了 5 年随访数据。
方法
对 331 例接受定制计算机辅助设计/计算机辅助制造 biblock MAD（Narval CC；ResMed，Saint-Priest，法国）治疗的患者中的 172 例患者进行了数据分析。主要终点为治疗成功（与基线相比，呼吸暂停低通气指数降低≥50%）。
结果
总体 5 年治疗成功率为 52%，轻度、中度和重度 OSA 患者的治疗成功率分别为 25%、52%和 63%。这反映了随时间推移的下降趋势，与 3-6 个月（总体 79%）和 2 年（68%）相比。所有患者亚组的治疗成功率均下降，但在轻度 OSA 患者中下降幅度最大。随着时间的推移，呼吸参数的轻微恶化与嗜睡和症状无任何相关变化。多变量分析显示，基线时中重度 OSA、3-6 个月时治疗成功以及无 CPAP 治疗史是 5 年治疗成功的独立预测因素。长期随访未出现新的安全性信号。93.3%的患者每晚至少使用 MAD 4 小时/天≥4 天/周，91.3%的患者报告在 5 年内每晚使用 MAD 6 小时/晚。在 5 年随访时，96.5%的患者报告希望继续接受 MAD 治疗。
结论
5 年后，超过 50%的患者长期接受 MAD 治疗仍有效，患者满意度和依从性良好。
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