基于药物诱导睡眠内镜的表型标记可改善下颌前伸装置治疗结果的患者选择：一项前瞻性研究。
Phenotypic Labelling Using Drug-Induced Sleep Endoscopy Improves Patient Selection for Mandibular Advancement Device Outcome: A Prospective Study.
机构信息
Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium; ENT, Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium; Multidisciplinary Sleep Disorders Centre, Antwerp University Hospital, Edegem, Belgium.
Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium; ENT, Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium; Special Dentistry Care, Antwerp University Hospital, Edegem, Belgium.
出版信息
J Clin Sleep Med. 2019 Aug 15;15(8):1089-1099. doi: 10.5664/jcsm.7796.
STUDY OBJECTIVES
Mandibular advancement device (MAD) outcome varies between patients. We hypothesized that upper airway collapse sites, patterns, and degrees assessed during baseline drug-induced sleep endoscopy (DISE) affect MAD outcome.
METHODS
One hundred patients with obstructive sleep apnea (OSA) were included and underwent baseline type 1 polysomnography. MAD was fitted intraorally at fixed 75% maximal protrusion. A total of 72 patients completed 3-month follow-up polysomnography and baseline DISE. Response was defined as apnea-hypopnea index (AHI) reduction ≥ 50%, deterioration as AHI increases during MAD treatment compared to baseline.
RESULTS
Adjusting for baseline AHI and body mass index, patients with tongue base collapse showed 3.69 higher odds (1.27-10.73; P = .0128) for response. Complete concentric collapse at the level of the palate (5.32 [1.21-23.28]; P = .0234) and complete laterolateral oropharyngeal collapse (6.62 [1.14-38.34]; P = .0330) related to deterioration. Results for tongue base collapse and complete concentric collapse at the level of the palate were confirmed in the moderate to severe OSA subgroup. Applying these results to this selected subgroup increased response rate with 54% and decreased deterioration rate with 53%. These results were confirmed using other response and deterioration definitions.
CONCLUSIONS
Three baseline DISE phenotypes identified during drug-induced sleep were significantly related to MAD treatment outcome: one beneficial, tongue base collapse, and two adverse, complete concentric collapse at the level of the palate and complete laterolateral oropharyngeal collapse. If confirmed in future prospective studies, these results could guide patient selection for MAD outcome.
CLINICAL TRIAL REGISTRATION
This prospective clinical trial (PROMAD) was registered on Clinicaltrials.gov with identifier: NCT01532050.
CITATION
Op de Beeck S, Dieltjens M, Verbruggen AE, Vroegop AV, Wouters K, Hamans E, Willemen M, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Phenotypic labelling using drug-induced sleep endoscopy improves patient selection for mandibular advancement device outcome: a prospective study. J Clin Sleep Med. 2019;15(8):1089-1099.
研究目的
下颌前伸装置（MAD）的治疗效果在不同患者间存在差异。我们假设，在基线药物诱导睡眠内镜检查（DISE）期间评估的上气道塌陷部位、模式和程度会影响 MAD 的治疗效果。
方法
100 例阻塞性睡眠呼吸暂停（OSA）患者纳入本研究，并接受基线 1 型多导睡眠图检查。MAD 通过口腔内固定 75%最大前伸位进行适配。共有 72 例患者完成了 3 个月的随访多导睡眠图和基线 DISE 检查。将 AHI 降低≥50%定义为有效，将 MAD 治疗期间 AHI 增加定义为无效。
结果
在调整基线 AHI 和体重指数后，舌根塌陷患者的有效概率高出 3.69 倍（1.27-10.73；P=0.0128）。软腭完全同心性塌陷（5.32 [1.21-23.28]；P=0.0234）和完全侧向或咽腔塌陷（6.62 [1.14-38.34]；P=0.0330）与无效相关。在中重度 OSA 亚组中，舌根塌陷和软腭完全同心性塌陷的结果得到了验证。将这些结果应用于所选亚组，可将有效率提高 54%，将无效率降低 53%。使用其他有效和无效的定义，得到了相似的结果。
结论
在药物诱导睡眠期间发现的三种基线 DISE 表型与 MAD 治疗效果显著相关：一种是有益的，即舌根塌陷；两种是不利的，即软腭完全同心性塌陷和完全侧向或咽腔塌陷。如果在未来的前瞻性研究中得到证实，这些结果可能会指导 MAD 治疗效果的患者选择。
临床试验注册
本前瞻性临床试验（PROMAD）在 ClinicalTrials.gov 上注册，标识符为：NCT01532050。
参考文献
Op de Beeck S, Dieltjens M, Verbruggen AE, Vroegop AV, Wouters K, Hamans E, Willemen M, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Phenotypic labelling using drug-induced sleep endoscopy improves patient selection for mandibular advancement device outcome: a prospective study. J Clin Sleep Med. 2019;15(8):1089-1099.
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