Tatla T, Sandhu G, Croft C B, Kotecha B
Whipps Cross Hospital, Leytonstone, London, UK.
J Laryngol Otol. 2003 Oct;117(10):801-6. doi: 10.1258/002221503770716241.
A prospective non-randomized study was designed to investigate the effects of Celon radio-frequency thermo-ablation (RFTA) of the soft palate in patients with snoring/mild obstructive sleep apnoea. Ten patients, fulfilling various inclusion/exclusion criteria, underwent single operator sub-mucosal RFTA palatoplasty as an office procedure. Two separate procedures six weeks apart involved each patient receiving six distinct sub-mucosal lesions on each visit. Questionnaires including visual analogue scales (VAS) were used to evaluate post-operative pain and subjective snoring (scored by patient/partner). Polysomnography (PSG) was performed pre-operation and three months following the second procedure. Using non-parametric statistical analysis, a significant reduction in VAS snoring was noted from initial levels to those scored at six and 16 weeks in nine of 10 patients (p = 0.013 and p = 0.007 respectively). (Five of these nine showed a greater than 50 per cent reduction in score). Objectively, six of 10 patients had a reduction in the apnoea-hypopnea Index between the two PSGs, (four of these six showed a greater than 50 per cent reduction) however, this was not statistically significant. Subjective assessment of the PSG snoring signal by the senior author showed eight of 10 patients had either a reduced or much reduced signal at four months. VAS pain confirmed both procedures are well tolerated with minimal analgesia requirements. Minor complaints of transient mild palatal swelling, dry throat, catarrh and referred otalgia were noted and one patient developed mucosal ulceration following both procedures that healed within three weeks. Swallowing and speech were unaffected. These results confirm similar findings using the Somnus Unit, although the Celon device provides additional advantages including inherent safety in a bipolar electrode tip, auto-stop energy application and reduced procedure time.
一项前瞻性非随机研究旨在调查软腭赛隆射频热消融术(RFTA)对打鼾/轻度阻塞性睡眠呼吸暂停患者的影响。10名符合各种纳入/排除标准的患者接受了由单一操作人员进行的黏膜下RFTA腭成形术,作为门诊手术。相隔六周的两次单独手术中,每位患者每次就诊时接受六个不同的黏膜下病灶治疗。使用包括视觉模拟量表(VAS)在内的问卷来评估术后疼痛和主观打鼾情况(由患者/伴侣评分)。术前及第二次手术后三个月进行多导睡眠图(PSG)检查。采用非参数统计分析,10名患者中有9名患者的VAS打鼾评分从初始水平显著降低至6周和16周时的评分(分别为p = 0.013和p = 0.007)。(这9名患者中有5名评分降低超过50%)。客观上,10名患者中有6名在两次PSG检查之间呼吸暂停低通气指数有所降低,(这6名患者中有4名降低超过50%),然而,这在统计学上并不显著。资深作者对PSG打鼾信号的主观评估显示,10名患者中有8名在四个月时信号减弱或大幅减弱。VAS疼痛证实这两种手术耐受性良好,镇痛需求 minimal。记录到有短暂轻度腭肿胀、咽干、卡他和牵涉性耳痛的轻微主诉,一名患者在两次手术后均出现黏膜溃疡,三周内愈合。吞咽和言语未受影响。这些结果证实了使用Somnus设备时的类似发现,尽管赛隆设备具有额外优势,包括双极电极尖端的固有安全性、自动停止能量应用和缩短手术时间。