Radiofrequency surgery of the soft palate in the treatment of snoring.: A placebo-controlled trial.
Radiofrequency surgery of the soft palate in the treatment of snoring.: A placebo-controlled trial.
复制标题
DOI：
10.1093/sleep/28.7.847
复制
发表时间：
2005-07-01
期刊：
影响因子：
5.6
通讯作者：
Maurer, JT
中科院分区：
文献类型：
--
作者：
Stuck, BA;Sauter, A;Maurer, JT
研究目的：最近的出版物已经证明了软腭射频（RF）手术可以减少打鼾。然而，迄今为止，所有发表的数据都是基于非对照试验。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。（AHI < 15，BMI < 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。按照雅阁方案，他们接受了2次射频手术（总能量：3.300焦耳）或安慰剂（插入器械针，无能量输送）。23例患者完成了研究; 12例接受了射频手术，11例接受了安慰剂。安慰剂组的打鼾评分没有变化（8.4 +/- 1.6至8.0 +/- 2.3），而RF组有所改善（8.1 +/- 1.3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，尽管我们组患者的打鼾减少仅为中度。这项研究强调了治疗打鼾的良好对照临床试验的必要性。
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 otorhinolaryngologyPatients: 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.