Rose Edmund C, Barthlen Gabriele M, Staats Richard, Jonas Irmtrud E
Department of Orthodontics, School of Dental Medicine, Albert-Ludwigs University of Freiburg i. Br., Hugstetter Strasse 55, 79106 Freiburg i. Br., Germany.
Am J Orthod Dentofacial Orthop. 2002 Mar;121(3):273-9. doi: 10.1067/mod.2002.121006.
The purpose of this study was to investigate the long-term efficacy of an oral appliance, the Karwetzky activator, on respiratory and sleep parameters in patients with obstructive sleep apnea (OSA). Those selected for this study were 26 patients polysomnographically diagnosed with mild-to-moderate OSA. They were initially treated successfully with this appliance, as documented by a second polysomnographic study after 6 to 12 weeks. Further polysomnographic registrations 6 to 12 months and 18 to 24 months later were performed for each patient wearing the appliance. For 21 patients (81%), therapeutic efficacy was maintained; 5 patients (19%) showed a deterioration in respiratory parameters. We corrected this by adjusting the device in 2 patients. The mean apnea-hypopnea index decreased significantly from 17.8 events per hour at the baseline registration to 4.2 events per hour (P <.001) after 6 to 12 weeks of treatment. After 6 to 12 months, the apnea-hypopnea index was 8.2 events per hour. The index remained at this level 18 to 24 months later, with 8.3 events per hour. Mean oxygen saturation was not improved with the activator, but the number of desaturations had decreased at the 6-to-12 week review. Again, the improvement declined with time, but the number of oxygen desaturations was still significantly decreased at 18 to 24 months (P <.01). Although the respiratory parameters remained statistically improved throughout the study (P <.01), sleep architecture did not change statistically. In most patients, therapeutic efficacy was maintained at the 2-year follow-up, although there was a tendency for effectiveness to fall over time. We concluded that the Karwetzky activator may be an effective treatment alternative for patients with mild-to-moderate OSA, but therapy requires diligent and regular polysomnographic follow-ups. Further long-term studies are needed to assess the continued efficacy of this oral appliance in treating OSA.
本研究的目的是调查一种口腔矫治器——卡尔韦茨基激活器，对阻塞性睡眠呼吸暂停（OSA）患者呼吸和睡眠参数的长期疗效。本研究选取了26例经多导睡眠图诊断为轻度至中度OSA的患者。他们最初使用该矫治器治疗成功，6至12周后的第二次多导睡眠图研究记录了这一点。在佩戴该矫治器的每位患者6至12个月以及18至24个月后进行了进一步的多导睡眠图记录。21例患者（81%）维持了治疗效果；5例患者（19%）呼吸参数恶化。我们对2例患者调整了矫治器来纠正这一情况。治疗6至12周后，平均呼吸暂停低通气指数从基线记录时的每小时17.8次事件显著降至每小时4.2次事件（P<.001）。6至12个月后，呼吸暂停低通气指数为每小时8.2次事件。18至24个月后该指数维持在这一水平，为每小时8.3次事件。激活器未改善平均血氧饱和度，但在6至12周复查时血氧饱和度下降次数减少。同样，这种改善随时间下降，但在18至24个月时血氧饱和度下降次数仍显著减少（P<.01）。尽管在整个研究中呼吸参数在统计学上仍有改善（P<.01），但睡眠结构在统计学上没有变化。在大多数患者中，2年随访时维持了治疗效果，尽管有效性有随时间下降的趋势。我们得出结论，卡尔韦茨基激活器可能是轻度至中度OSA患者的一种有效治疗选择，但治疗需要认真且定期的多导睡眠图随访。需要进一步的长期研究来评估这种口腔矫治器治疗OSA的持续疗效。
