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用于体位性阻塞性睡眠呼吸暂停患者口腔矫治器治疗的逐步滴定方案:概念验证

A stepwise titration protocol for oral appliance therapy in positional obstructive sleep apnea patients: proof of concept.

作者信息

de Ruiter M H T, Aarab G, de Vries N, Lobbezoo F, de Lange J

机构信息

Department of Oral and Maxillofacial Surgery of the Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.

Department of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.

出版信息

Sleep Breath. 2020 Sep;24(3):1229-1236. doi: 10.1007/s11325-020-02045-w. Epub 2020 Mar 11.

Abstract

PURPOSE

In patients with positional obstructive sleep apnea (POSA), oral appliance therapy (OAT) is among the first-line treatments. The aim of this study was to evaluate the effects of a new standardized stepwise titration protocol for OAT in a group of patients with POSA.

METHODS

This was an observational intervention trial. Patients who were previously randomized to the OAT intervention arm of a comparison study comprised the subjects for this study. These patients, who had mild to moderate POSA, were assessed after 3 and 12 months for treatment efficacy, objective adherence by temperature microsensor, and side effects. The titration of OAT was performed using a standardized stepwise titration protocol including advancement levels of 60%, 75%, and 90% of the maximum mandibular protrusion. The optimal advancement level per individual was based on a weighted compromise between efficacy and side effects.

RESULTS

In total, 36 patients were included and all completed the titration protocol after 3 months. At baseline, the OAT was set at 60% of the maximal mandibular protrusion position. At a 3-month evaluation, the advancement remained at 60% in 16 patients (44%) and reached 75% advancement in 20 patients (56%). Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months. The 12-month analysis showed consistent results and good OAT tolerance. Six patients (16.7%) terminated OAT and one patient (2.8%) was lost to follow-up.

CONCLUSIONS

This standardized stepwise titration protocol for OAT showed good efficacy, good OAT tolerance, and good objective adherence in patients with mild to moderate POSA. Therefore, the protocol is recommended in research projects to improve standardization of methods between studies and in clinical practice for its practical feasibility.

摘要

目的

在体位性阻塞性睡眠呼吸暂停(POSA)患者中,口腔矫治器疗法(OAT)是一线治疗方法之一。本研究的目的是评估一种新的标准化逐步滴定方案对一组POSA患者进行OAT治疗的效果。

方法

这是一项观察性干预试验。先前被随机分配到一项比较研究的OAT干预组的患者构成了本研究的对象。这些患有轻度至中度POSA的患者在3个月和12个月后接受治疗效果、通过温度微传感器评估的客观依从性以及副作用的评估。OAT的滴定使用标准化逐步滴定方案进行,包括下颌最大前伸量的60%、75%和90%的进阶水平。每个个体的最佳进阶水平基于疗效和副作用之间的加权折衷。

结果

总共纳入36例患者,所有患者在3个月后均完成滴定方案。基线时,OAT设置在下颌最大前伸位置的60%。在3个月的评估中,16例患者(44%)的进阶水平仍为60%,20例患者(56%)达到75%的进阶水平。平均呼吸暂停低通气指数从每小时12.9次事件(9.1 - 16.7)降至6.9次(3.7 - 10.3)(P < 0.001),3个月后的中位客观依从性为97.4(61.4 - 100.00)。12个月的分析显示结果一致且OAT耐受性良好。6例患者(16.7%)终止OAT,1例患者(2.8%)失访。

结论

这种用于OAT的标准化逐步滴定方案在轻度至中度POSA患者中显示出良好的疗效、良好的OAT耐受性和良好的客观依从性。因此,该方案在研究项目中被推荐,以提高研究之间方法的标准化,并因其实际可行性在临床实践中被推荐。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1025/7426292/3af9d8560200/11325_2020_2045_Fig1_HTML.jpg

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