Chicago Nasal & Sinus Center, Chicago, Illinois, USA.
Madison ENT & Facial Plastic Surgery, New York, New York, USA.
Int Forum Allergy Rhinol. 2024 Oct;14(10):1549-1557. doi: 10.1002/alr.23383. Epub 2024 Jun 6.
Improved nasal airway obstruction (NAO) symptoms were reported at 3 months following temperature-controlled radiofrequency (TCRF) treatment of the septal swell body (SSB). This report provides results from assessments of the long-term safety and efficacy of TCRF treatment of SSB hypertrophy to treat NAO through 12 months posttreatment.
This prospective, multicenter, long-term, open-label study was conducted in nine centers within the United States and included patients with severe/extreme NAO attributed to SSB hypertrophy. Outcome measures included assessments of Nasal Obstruction Symptom Evaluation Score (NOSE), Numeric Rating Scale (NRS) ease-of-breathing, patient satisfaction, and adverse events at 6 and 12 months.
Of the 70 patients treated, 65 and 62 patients completed the 6- and 12-month follow-up assessments. Compared to baseline, there was a 67.5% decrease in adjusted mean NOSE scores at 6 months (mean change -49.6, 95% confidence interval [CI] -54.8 to -44.4; p < 0.001) and a 65.4% decrease at 12 months (mean change -48.1, 95% CI -53.7 to -42.5); p < 0.001), which is consistent with previously published 3-month results. A 62.0% and 62.5% improvement compared to baseline was observed in the NRS ease-of-breathing score at 6 and 12 months, respectively (p < 0.001). No serious adverse were reported overall and no new device- or procedure-related adverse events were reported in the interval between 3 and 12 months posttreatment.
TCRF treatment of SSB hypertrophy has a significant and durable effect on improving the symptoms of NAO and health-related quality of life in patients with symptoms of nasal obstruction and congestion through 12 months postprocedure.
经控温热射频（TCRF）治疗鼻中隔肿胀体（SSB）后 3 个月，患者的鼻腔气道阻塞（NAO）症状得到改善。本报告提供了 TCRF 治疗 SSB 肥大以治疗 NAO 的长期安全性和疗效评估结果，治疗后随访时间长达 12 个月。
这是一项在美国 9 个中心进行的前瞻性、多中心、长期、开放性研究，纳入了因 SSB 肥大而导致严重/极度 NAO 的患者。主要结局指标包括鼻腔阻塞症状评估量表（NOSE）、呼吸困难数字评分量表（NRS）、患者满意度和治疗后 6 个月和 12 个月的不良事件。
在 70 例接受治疗的患者中，有 65 例和 62 例患者完成了 6 个月和 12 个月的随访评估。与基线相比，6 个月时调整后的平均 NOSE 评分下降了 67.5%（平均变化-49.6，95%置信区间[CI] -54.8 至-44.4；p<0.001），12 个月时下降了 65.4%（平均变化-48.1，95%CI -53.7 至-42.5；p<0.001），这与之前发表的 3 个月结果一致。在 6 个月和 12 个月时，NRS 呼吸困难评分分别观察到 62.0%和 62.5%的改善，与基线相比（p<0.001）。总的来说，没有严重不良事件报告，在治疗后 3 至 12 个月期间没有报告新的与设备或手术相关的不良事件。
TCRF 治疗 SSB 肥大可显著且持久地改善鼻塞和充血患者的 NAO 症状和健康相关生活质量，治疗后 12 个月内效果持续存在。
