Nordgård Ståle, Wormdal Kjell, Bugten Vegard, Stene Brit K, Skjøstad Ketil W
Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital, NO-7006 Trondheim, Norway.
Acta Otolaryngol. 2004 Oct;124(8):970-5. doi: 10.1080/00016480310017090.
To evaluate the safety, feasibility and effectiveness of a treatment for snoring using permanent palatal implants.
This was a prospective, non-randomized study involving 35 healthy patients (26 males, 9 females) referred for treatment of habitual snoring. A baseline medical examination, an evaluation of snoring-related subjective symptoms and an overnight sleep analysis were performed. Three PET implants were placed in the palate of each patient using a new delivery device under local anaesthesia. The patients were followed by means of office visits at 2-3, 14, 30 and 90 days postoperatively, at which discomfort, pain, adverse events and changes in snoring-related parameters were recorded.
The average time required for the procedure was 8 min; 23% of the patients required no postoperative analgesia; the average consumption of analgesic was 125 mg of diclofenac and the average duration of analgesia was 1.5 days after the procedure. No bleeding, haematoma or infection were observed. Two of the implants were extruded; both of these patients experienced a satisfactory reduction in snoring intensity and no replacements were necessary. The mean reduction in snoring intensity was 51%, with the visual analogue scale score evaluated by the bed partner falling from 7.3 to 3.6 (p<0.001). The Epworth Sleepiness Score dropped from 9.3 to 4.6 (p<0.001). In total, 86% of the bed partners and 89% of the patients recommended the procedure.
The new palatal implant system is safe and is associated with low morbidity. It is a fast, simple and effective treatment for snoring.
评估使用永久性腭植入物治疗打鼾的安全性、可行性和有效性。
这是一项前瞻性、非随机研究，纳入了35例因习惯性打鼾前来治疗的健康患者（26例男性，9例女性）。进行了基线医学检查、打鼾相关主观症状评估和整夜睡眠分析。在局部麻醉下，使用一种新的输送装置在每位患者的腭部植入3枚聚对苯二甲酸乙二酯（PET）植入物。术后2 - 3天、14天、30天和90天对患者进行门诊随访，记录不适、疼痛、不良事件以及打鼾相关参数的变化。
该手术平均所需时间为8分钟；23%的患者术后无需镇痛；镇痛药物的平均消耗量为125毫克双氯芬酸，术后镇痛的平均持续时间为1.5天。未观察到出血、血肿或感染情况。有2枚植入物发生移位；这2例患者的打鼾强度均有令人满意的降低，无需更换植入物。打鼾强度平均降低了51%，由同床伴侣评估的视觉模拟量表评分从7.3降至3.6（p<0.001）。爱泼沃斯嗜睡量表评分从9.3降至4.6（p<0.001）。总体而言，86%的同床伴侣和89%的患者推荐该手术。
新型腭植入系统安全，发病率低。它是一种治疗打鼾的快速、简单且有效的方法。
