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一项针对两种腭部手术治疗睡眠呼吸障碍的前瞻性随机试验的初步结果。

Preliminary findings from a prospective, randomized trial of two palatal operations for sleep-disordered breathing.

作者信息

Terris David J, Coker Joan F, Thomas Adrian J, Chavoya Martha

机构信息

Department of Otolaryngology-Head and Neck Surgery, Stanford University Medical Center, USA.

出版信息

Otolaryngol Head Neck Surg. 2002 Oct;127(4):315-23. doi: 10.1067/mhn.2002.128345.

Abstract

OBJECTIVES

We compared the efficacy of 2 palatal surgical procedures in the treatment of patients with mild sleep-disordered breathing (SDB).

STUDY DESIGN AND SETTING

We conducted a prospective, randomized, crossover surgical trial at a university hospital.

METHODS

Twenty patients with mild SDB for whom conservative treatment failed were identified and consecutively enrolled into an institutional review board-approved surgical protocol. They were randomly assigned to undergo either radiofrequency ablation of the palate (RFAP) for a planned 3-stage treatment or laser-assisted uvulopalatoplasty (LAUP), also for 3 stages of treatment, using a CO(2) laser. Parameters assessed included severity of SDB (polysomnography), subjective and objective loudness of snoring (visual analog scale and SNAP recording), sleepiness (Epworth Sleepiness Scale), and anatomic changes (upper airway endoscopy), as well as demographic factors. Patients not achieving satisfactory improvement in their condition were crossed over to the alternative surgical therapy for attempted salvage.

RESULTS

Seventeen of the enrolled patients have completed the protocol. Ten of these were randomized to the RFAP group, and 7 to the LAUP group. Six of the RFAP patients (60%) achieved a satisfactory resolution of their snoring, and 4 failed and were salvaged with LAUP. Six of the LAUP patients (86%) achieved a satisfactory resolution of their snoring, and 1 patient failed and was salvaged with nasal surgery. One patient who was initially cured had a relapse after 9 months and was successfully salvaged with RFA.

CONCLUSION

Prospective, randomized trials of surgery for SDB are possible. Preliminary findings from the current protocol reveal a slight advantage of LAUP over RFAP but with a greater degree of discomfort postoperatively.

摘要

目的

我们比较了两种腭部手术方法治疗轻度睡眠呼吸障碍(SDB)患者的疗效。

研究设计与地点

我们在一家大学医院进行了一项前瞻性、随机、交叉手术试验。

方法

确定20例保守治疗失败的轻度SDB患者,并连续纳入经机构审查委员会批准的手术方案。他们被随机分配接受计划分3阶段进行的腭部射频消融术(RFAP)或同样分3阶段进行的二氧化碳激光辅助悬雍垂腭咽成形术(LAUP)。评估的参数包括SDB的严重程度(多导睡眠图)、打鼾的主观和客观响度(视觉模拟量表和SNAP记录)、嗜睡程度(爱泼华嗜睡量表)、解剖学变化(上气道内窥镜检查)以及人口统计学因素。病情未得到满意改善的患者改用另一种手术治疗以尝试补救。

结果

17例入选患者完成了该方案。其中10例被随机分配到RFAP组,7例被分配到LAUP组。RFAP组中有6例患者(60%)打鼾得到满意缓解,4例失败后改用LAUP补救。LAUP组中有6例患者(86%)打鼾得到满意缓解,1例患者失败后接受鼻腔手术补救。1例最初治愈的患者在9个月后复发,经射频消融成功补救。

结论

对SDB进行前瞻性、随机手术试验是可行的。当前方案的初步结果显示LAUP比RFAP略有优势,但术后不适程度更高。

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