Madison ENT & Facial Plastic Surgery, New York, NY.
ENT and Allergy Associates of Florida, Coral Springs, FL.
Int Forum Allergy Rhinol. 2021 Dec;11(12):1676-1684. doi: 10.1002/alr.22861. Epub 2021 Jul 9.
Nasal valve collapse is one of several causes of nasal obstruction. The safety and efficacy of a temperature-controlled radiofrequency (RF) device for the treatment of the nasal valve for nasal airway obstruction (NAO) has been established in single-arm studies. The objective of this trial was to compare active device treatment against a sham procedure (control).
In a prospective, multicenter, single-blinded, randomized controlled trial (RCT), patients were assigned to bilateral temperature-controlled RF treatment of the nasal valve (n = 77) or a sham procedure (n = 41), in which no RF energy was transferred to the device/treatment area. The device was applied to the mucosa over the lower lateral cartilage on the lateral nasal wall. The primary endpoint was responder rate at 3 months, defined as a ≥20% reduction in Nasal Obstruction Symptom Evaluation (NOSE)-scale score or ≥1 reduction in clinical severity category.
At baseline, patients had a mean NOSE-scale score of 76.7 (95% confidence interval [CI], 73.8 to 79.5) and 78.8 (95% CI, 74.2 to 83.3) (p = 0.424) in the active treatment and sham-control arms, respectively. At 3 months, the responder rate was significantly higher in the active treatment arm (88.3% [95% CI, 79.2%-93.7%] vs 42.5% [95% CI, 28.5%-57.8%]; p < 0.001). The active treatment arm had a significantly greater decrease in NOSE-scale score (mean, -42.3 [95% CI, -47.6 to -37.1] vs -16.8 [95% CI, -26.3 to -7.2]; p < 0.001). Three adverse events at least possibly related to the device and/or procedure were reported, and all resolved.
This RCT shows temperature-controlled RF treatment of the nasal valve is safe and effective in reducing symptoms of NAO in short-term follow-up.
鼻阀塌陷是引起鼻阻塞的几个原因之一。在单臂研究中，已证实经温控射频（RF）设备治疗鼻阀治疗鼻气道阻塞（NAO）的安全性和有效性。本试验的目的是比较主动设备治疗与假手术（对照）的效果。
在一项前瞻性、多中心、单盲、随机对照试验（RCT）中，患者被分配至双侧经温控 RF 治疗鼻阀（n=77）或假手术（n=41），在假手术中，设备/治疗区域未传输 RF 能量。设备被施加于外侧鼻甲外侧壁的粘膜上。主要终点为 3 个月时的应答率，定义为鼻阻塞症状评估（NOSE）量表评分降低≥20%或临床严重程度类别降低≥1。
在基线时，患者的 NOSE 量表评分分别为 76.7（95%置信区间[CI]，73.8 至 79.5）和 78.8（95% CI，74.2 至 83.3）（p=0.424），在主动治疗和假手术对照组中。在 3 个月时，主动治疗组的应答率显著更高（88.3%[95% CI，79.2%-93.7%] vs 42.5%[95% CI，28.5%-57.8%]；p<0.001）。主动治疗组的 NOSE 量表评分显著降低（平均，-42.3[95% CI，-47.6 至-37.1] vs -16.8[95% CI，-26.3 至-7.2]；p<0.001）。至少有 3 例与设备和/或手术相关的不良事件被报告，且均已解决。
这项 RCT 表明，在短期随访中，经温控 RF 治疗鼻阀是安全且有效的，可以减轻 NAO 症状。
