患者报告的结果：多中心德国上市后研究的结果。
Patient-reported outcome: results of the multicenter German post-market study.
机构信息
Department of Otorhinolaryngology, University of Lübeck, Ratzeburger Allee, 23538, Lübeck, Germany.
Department of Otorhinolaryngology, Head and Neck Surgery, Klinikum rechts der Isar, Munich, Germany.
出版信息
Eur Arch Otorhinolaryngol. 2018 Jul;275(7):1913-1919. doi: 10.1007/s00405-018-5017-1. Epub 2018 May 28.
PURPOSE
Upper airway stimulation (UAS) is an alternative second-line treatment option for patients with obstructive sleep apnea (OSA). In our substudy of a previous multicentre study of patients implanted with UAS, we focused on patient-related outcomes like Epworth Sleepiness Scale (ESS), the Functional Outcomes of Sleep Questionnaire (FOSQ), snoring and personal satisfaction 6 and 12 months after the implantation.
METHODS
60 patients, who were initially non-adherent to CPAP and implanted with UAS, were included in a prospective multicentre study. Data were collected preoperative, 6 and 12 months after implantation regarding FOSQ, ESS, snoring, and their experience with the UAS device.
RESULTS
Besides relevant Apnoea-Hypopnea Index (AHI) reduction, we saw significant improvements in ESS (p < 0.001), FOSQ (p < 0.001) and snoring under UAS therapy. A strong correlation between AHI results postoperative and the personal satisfaction of the patients after implantation was found as well as between usage results and AHI compared to the preoperative results.
CONCLUSION
The more the patients benefit from UAS according to their self-reported outcome, the higher is the therapy use.
目的
上气道刺激（UAS）是阻塞性睡眠呼吸暂停（OSA）患者的二线替代治疗选择。在我们对先前接受 UAS 植入的多中心患者进行的子研究中，我们关注与患者相关的结果，如嗜睡量表（ESS）、睡眠功能结局问卷（FOSQ）、打鼾和植入后 6 个月和 12 个月的个人满意度。
方法
60 名最初对 CPAP 治疗不依从并植入 UAS 的患者被纳入前瞻性多中心研究。在植入前、植入后 6 个月和 12 个月收集有关 FOSQ、ESS、打鼾以及他们对 UAS 设备体验的数据。
结果
除了相关的呼吸暂停低通气指数（AHI）降低外，我们还发现 UAS 治疗后 ESS（p<0.001）、FOSQ（p<0.001）和打鼾均有显著改善。术后 AHI 结果与患者植入后的个人满意度之间以及与使用结果与术前结果之间存在很强的相关性。
结论
根据患者的自我报告结果，患者从 UAS 中获益越多，治疗使用的频率就越高。
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