Vecchierini Marie-Françoise, Attali Valérie, Collet Jean-Marc, d'Ortho Marie-Pia, Goutorbe Frederic, Kerbrat Jean-Baptiste, Leger Damien, Lavergne Florent, Monaca Christelle, Monteyrol Pierre-Jean, Morin Laurent, Mullens Eric, Pigearias Bernard, Martin Francis, Khemliche Hauria, Lerousseau Lionel, Meurice Jean-Claude, Abedipour Darius, Allard-Redon Aurélie, Aranda Alexandre, Attali Valérie, Bavozet Frédérique, Becu Martine, Beruben Wally, Bessard Jerome, Bonafe Isabelle, Boukhana Mohammed, Chabrol Bruno, Chatte Gérard, Lebret Chauvel, Collet Jean-Marc, Coste Olivier, Dumont Nathalie, Durand-Amat Sophie, D'ortho Marie-Pia, Elbaum Jean Marc, De Santerre Olivier Gallet, Goutorbes Frédéric, Grandjean Thierry, Guyot Wilma, Hammer Doniphan, Havasi Carmen, Huet Pascal, Kerbrat Jean Baptiste, Khemliche Hauria, Koltes Christian, Leger Damien, Lacassagne Laurent, Laur Xavier, Lerousseau Lionel, Liard Olivier, Loisel Christophe, Longuet Matthieu, Mallart Anne, Martin Francis, Merle Beral Frédéric, Meurice Jean Claude, Mokhtari Zoubida, Monaca Christelle, Monteyrol Pierre Jean, Muir Jean-François, Mullens Eric, Muller Dominique, Paoli Charles, Petit François Xavier, Pigearias Bernard, Pradines Marc, Prigent Arnauld, Putterman Gil, Rey Marc, Samama Mickael, Tamisier Renaud, Tiberge Michel, Tison Cyrille, Tordjman Fabienne, Triolet Bernard, Vacher Christian, Vecchierini Marie-Françoise, Verain Alain
AP-HP, Centre du Sommeil et de la Vigilance, Hôpital Hôtel Dieu, Paris, France.
Sorbonne Paris Cité, Université Paris Descartes, Paris, France.
Sleep Breath. 2019 Sep;23(3):837-848. doi: 10.1007/s11325-018-1766-8. Epub 2018 Dec 22.
Mandibular repositioning devices (MRDs) are an effective treatment option for obstructive sleep apnea syndrome (OSAS), particularly in patients who refuse or cannot tolerate continuous positive airway pressure (CPAP). However, sex differences in the response to therapy and predictors of response are not clearly defined. This analysis of data from the long-term prospective ORCADES trial compared MRD efficacy in men and women with OSAS.
The ORCADES study included patients with newly diagnosed mild-to-moderate or severe OSAS who refused or were non-compliant with CPAP. MRD therapy was titrated over 3-6 months. The primary endpoint was treatment success (≥ 50% decrease in apnea-hypopnea index (AHI)). Complete response was defined using a range of AHI cut-off values (< 5/h, < 10/h, < 15/h).
Overall treatment success rates were 89% in women and 76% in men (p = 0.019); corresponding rates in those with severe OSAS (AHI > 30/h) were 100% and 68% (p = 0.0015). In women vs. men, overall complete response rates at AHI cut-off values of < 5/h, <10/h, and < 15/h were 49 vs. 34% (p = 0.0052), 78 vs. 62% (p = 0.016), and 92 vs. 76% (p = 0.0032). On multivariate analysis, significant predictors of MRD treatment success were overbite and baseline apnea index in men, and neck circumference and no previous CPAP therapy in women. There were sex differences in the occurrence of side effects. Temporomandibular joint pain was the most common reason for stopping MRD therapy.
MRD therapy was effective in women with OSA of any severity, with significantly higher response rates compared with men especially in severe OSAS.
www.clinicaltrials.gov (NCT01326143).
下颌重新定位装置(MRD)是阻塞性睡眠呼吸暂停综合征(OSAS)的一种有效治疗选择,尤其适用于拒绝或无法耐受持续气道正压通气(CPAP)的患者。然而,治疗反应的性别差异以及反应的预测因素尚未明确界定。这项对长期前瞻性ORCADES试验数据的分析比较了MRD对男性和女性OSAS患者的疗效。
ORCADES研究纳入了新诊断为轻度至中度或重度OSAS且拒绝或不依从CPAP治疗的患者。MRD治疗在3至6个月内进行滴定。主要终点是治疗成功(呼吸暂停低通气指数(AHI)降低≥50%)。使用一系列AHI截断值(<5/h、<10/h、<15/h)定义完全缓解。
女性的总体治疗成功率为89%,男性为76%(p = 0.019);重度OSAS(AHI>30/h)患者的相应成功率分别为100%和68%(p = 0.0015)。在女性与男性中,AHI截断值<5/h、<10/h和<15/h时的总体完全缓解率分别为49%对34%(p = 0.0052)、78%对62%(p = 0.016)、92%对76%(p = 0.0032)。多因素分析显示,MRD治疗成功的显著预测因素在男性中是覆牙合和基线呼吸暂停指数,在女性中是颈围和既往未接受CPAP治疗。副作用的发生存在性别差异。颞下颌关节疼痛是停止MRD治疗的最常见原因。
MRD治疗对任何严重程度的女性OSA均有效,与男性相比反应率显著更高,尤其是在重度OSAS中。