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软腭射频手术治疗打鼾:一项安慰剂对照试验。

Radiofrequency surgery of the soft palate in the treatment of snoring. A placebo-controlled trial.

作者信息

Stuck Boris A, Sauter Alexander, Hörmann Karl, Verse Thomas, Maurer Joachim T

机构信息

Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, Mannheim, Germany.

出版信息

Sleep. 2005 Jul;28(7):847-50. doi: 10.1093/sleep/28.7.847.

Abstract

STUDY OBJECTIVES

Recent publications have demonstrated a reduction in snoring with radiofrequency (RF) surgery of the soft palate. Yet so far, all published data has been based on non-controlled trials.

DESIGN

Aim of this study was to assess the efficacy of RF surgery of the soft palate in a randomized, placebo-controlled trial.

SETTING

Outpatients department at university hospital, department of otorhinolaryngology.

PATIENTS

26 patients with primary snoring (AHI < 15, BMI < 35).

INTERVENTIONS

Patients were treated with temperature-controlled RF surgery of the soft palate under local anesthesia. In accord with a randomization protocol they received 2 sessions of RF surgery (total amount of energy: 3.300 Joule) or placebo (insertion of device needle without energy delivery).

MEASUREMENTS AND RESULTS

Snoring was evaluated by the bed partner with 10 cm visual analogue scales. 23 patients completed the study; 12 received RF-surgery and 11 received placebo. Snoring scores did not change in the placebo group (8.4 +/- 1.6 to 8.0 +/- 2.3) while improving in the RF-group (8.1 +/- 1.3 to 5.2 +/- 2.4). The difference between the groups was statistically significant (p < 0.05).

CONCLUSION

RF-surgery was significantly better than placebo, although the reduction in snoring was only moderate in our group of patients. This study underlines the necessity for well-controlled clinical trials in the treatment of snoring.

摘要

研究目的

近期发表的文献表明,软腭射频(RF)手术可减少打鼾。然而,迄今为止,所有已发表的数据均基于非对照试验。

设计

本研究的目的是在一项随机、安慰剂对照试验中评估软腭射频手术的疗效。

地点

大学医院耳鼻喉科门诊。

患者

26例原发性打鼾患者(呼吸暂停低通气指数<15,体重指数<35)。

干预措施

患者在局部麻醉下接受软腭温控射频手术治疗。根据随机分组方案,他们接受2次射频手术(总能量:3300焦耳)或安慰剂治疗(插入器械针但不输送能量)。

测量与结果

由同床伴侣使用10厘米视觉模拟量表评估打鼾情况。23例患者完成了研究;12例接受射频手术,11例接受安慰剂治疗。安慰剂组打鼾评分无变化(从8.4±1.6降至8.0±2.3),而射频组有所改善(从8.1±1.3降至5.2±2.4)。两组之间的差异具有统计学意义(p<0.05)。

结论

射频手术明显优于安慰剂,尽管在我们的患者组中打鼾减少程度仅为中度。本研究强调了在打鼾治疗中进行严格对照临床试验的必要性。

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