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[阻塞性睡眠呼吸暂停外科治疗的随机对照试验]

[Randomized controlled trials in the surgical treatment of obstructive sleep apnea].

作者信息

Sommer J U, Maurer J T, Hörmann K, Stuck B A

机构信息

Universitäts-HNO-Klinik Mannheim, Universitätsmedizin Mannheim, 68135, Mannheim, Deutschland.

出版信息

HNO. 2012 Apr;60(4):294-9. doi: 10.1007/s00106-011-2468-8.

Abstract

The need for surgical treatment alternatives for obstructive sleep apnea is unchanged. However, recommendations regarding these treatments can often only be given with caution as there are only a limited number of controlled studies available. To perform controlled trials and even more so placebo controlled trials in the field of sleep surgery is challenging, especially in comparison to studies evaluating conservative approaches. Nevertheless, these studies can be carried out also in the field of sleep surgery. In this review we present recent concepts and high-quality surgical trials with innovative study designs. A Medline search revealed 310 studies regarding surgical treatment of sleep apnea. These studies were assessed regarding quality, execution and number of subjects. A total of 12 randomized controlled studies were identified addressing palatal implants, radio-frequency surgery, nasal surgery, maxillomandibular advancement and laser-assisted uvulopalatoplasty (LAUP). Furthermore this review addresses the limitations of surgical studies and the differences compared to trials dealing with conservative approaches. The studies presented in this review demonstrate that high-quality trials regarding surgical treatment of obstructive sleep apnea are feasible and can lead to recommendations with high evidence levels.

摘要

对于阻塞性睡眠呼吸暂停,对外科治疗替代方案的需求并未改变。然而,由于可用的对照研究数量有限,关于这些治疗的建议往往只能谨慎给出。在睡眠外科领域进行对照试验,尤其是安慰剂对照试验具有挑战性,特别是与评估保守治疗方法的研究相比。尽管如此,这些研究在睡眠外科领域也能够开展。在本综述中,我们介绍了具有创新研究设计的最新概念和高质量外科试验。一项医学文献数据库搜索显示了310项关于睡眠呼吸暂停外科治疗的研究。这些研究在质量、实施情况和受试者数量方面进行了评估。总共确定了12项随机对照研究,涉及腭植入物、射频手术、鼻腔手术、上颌下颌前移和激光辅助悬雍垂腭咽成形术(LAUP)。此外,本综述还探讨了外科研究的局限性以及与处理保守治疗方法的试验相比存在的差异。本综述中呈现的研究表明,关于阻塞性睡眠呼吸暂停外科治疗的高质量试验是可行的,并且能够得出具有高证据水平的建议。

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