A randomized, controlled crossover trial of two oral appliances for sleep apnea treatment
A randomized, controlled crossover trial of two oral appliances for sleep apnea treatment
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DOI：
10.1164/ajrccm.162.1.9908112
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发表时间：
2000-07-01
影响因子：
24.7
通讯作者：
Russi, EW
中科院分区：
文献类型：
--
作者：
Bloch, KE;Iseli, A;Russi, EW
我们的目的是比较一种新的，单件式下颌前移装置（OSA-Monobloc）的有效性和副作用的睡眠呼吸暂停治疗与两件式器具与横向Herbst附件（OSA-Herbst）在以前的研究中使用。对24例无法使用持续气道正压通气（CPAP）治疗的阻塞性睡眠呼吸暂停患者安装了具有相同突出度的OSA-Monobloc和OSA-Herbst。经过156 +/- 14 d（平均值= SE）的适应期后，患者随机使用OSA-Monobloc、OSA-Herbst和无矫治器，每种矫治器使用1周。记录症状评分，并在每周结束时进行睡眠研究。两种器械均显著改善了几项症状评分，但OSA Monobloc的改善程度更大。使用OSA-Herbst的埃普沃思嗜睡量表评分为8.8 +/- 0.7，使用OSA-Monobloc器械的评分为8.6 +/- 0.8，未治疗的评分为13.1 +/- 0.9（与两种器械相比p < 0.05）。使用OSA-Herbst的呼吸暂停/呼吸不足指数为8.7 +/- 1.5/h，使用OSA-Monobloc器械的呼吸暂停/呼吸不足指数为7.9 +/- 1.6/h，未接受治疗的呼吸暂停/呼吸不足指数为22.6 +/- 3.1/h（与两种器械相比，p < 0.05）。副作用轻微，两种器具的患病率相同。15名患者首选OSA-Monobloc，8名患者无偏好，1名患者首选OSA-Herbst器械（与OSA-Monobloc相比p < 0.008）。我们得出结论，OSA-Herbst和OSA-Monobloc都是有效的睡眠呼吸暂停治疗设备。OSA-Monobloc比OSA-Herbst在更大程度上缓解了症状，并且基于其简单的应用而被大多数患者所偏好。
Our purpose was to compare the effectiveness and side effects of a novel, single-piece mandibular advancement device (OSA-Monobloc) for sleep apnea therapy with those of a two-piece appliance with lateral Herbst attachments (OSA-Herbst) as used in previous studies. An OSA-Monobloc and an OSA-Herbst with equal protrusion were fitted in 24 obstructive sleep apnea patients unable to use continuous positive airway pressure (CPAP) therapy. After an adaptation period of 156 +/- 14 d (mean = SE), patients used the OSA-Monobloc, the OSA-Herbst, and no appliance in random order, using each appliance for 1 wk. Symptom scores were recorded and sleep studies were done at the end of each week. Several symptom scores were significantly improved with both appliances, but to a greater degree with the OSA-Monobloc. Epworth Sleepiness Scale scores were 8.8 +/- 0.7 with the OSA-Herbst, and 8.6 +/- 0.8 with the OSA-Monobloc devices, and 13.1 +/- 0.9 without therapy (p < 0.05 versus both appliances). The apnea/hypopnea index was 8.7 +/- 1.5/h with the OSA-Herbst and 7.9 +/- 1.6/h with the OSA-Monobloc device, and 22.6 +/- 3.1/h without therapy (p < 0.05 Versus both appliances). Side effects were mild and of equal prevalence with both appliances. Fifteen patients preferred the OSA-Monobloc, eight patients had no preference, and one patient preferred the OSA-Herbst device (p < 0.008 versus OSA-Monobloc). We conclude that both the OSA-Herbst and the OSA-Monobloc are effective therapeutic devices for sleep apnea. The OSA-Monobloc relieved symptoms to a greater extent than the OSA-Herbst, and was preferred by the majority of patients on the basis of its simple application.