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创新多点阻抗控制射频消融后鼻神经治疗慢性鼻炎的临床疗效

Clinical Outcomes After Innovative Multipoint Impedance-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve for Treatment of Chronic Rhinitis.

作者信息

Davis Greg E, Ow Randall A, Yen David M, O'Malley Ellen M, Del Signore Anthony G

机构信息

Proliance Surgeons, Seattle and Puyallup, WA, USA.

Sacramento Ear, Nose, and Throat, Roseville, CA, USA.

出版信息

Ear Nose Throat J. 2024 Sep 24:1455613241285134. doi: 10.1177/01455613241285134.

Abstract

Chronic rhinitis substantially impacts a person's quality of life. We evaluated a novel, multipoint, impedance-controlled, radiofrequency ablation device for the treatment of chronic rhinitis. This was a prospective, multicenter, single-arm clinical study of posterior nasal nerve ablation in adults with chronic rhinitis. The primary efficacy endpoint was the change in reflective Total Nasal Symptom Score (rTNSS) at 6-month follow-up. Additional assessments included the Eustachian Tube Dysfunction Questionnaire (ETDQ-7), Nasal Obstruction Symptom Evaluation (NOSE), and mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ). The primary safety endpoint was the incidence of related serious adverse events. Seventy-nine of 80 enrolled participants completed 6-month follow-up. Statistically significant improvements were observed for mean change in rTNSS (-4.2), ETDQ-7 (-1.2), NOSE (-33.5), and mini-RQLQ (-1.8; < .0001 for all). Allergic and nonallergic rhinitis subgroups demonstrated significant improvement in all assessments ( < .0001) with no significant differences between subgroups. Higher baseline rTNSS was associated with greater improvements at follow-up. One serious adverse event of epistaxis was reported. The results of this study demonstrate the efficacy and safety of a multipoint, impedance-controlled, radiofrequency ablation device for the treatment of chronic rhinitis. Significant improvements were observed in rTNSS, ETDQ-7, NOSE, and mini-RQLQ assessments. www.clinicaltrials.gov. Unique identifier NCT05591989.

摘要

慢性鼻炎严重影响人的生活质量。我们评估了一种新型的、多点、阻抗控制的射频消融装置用于治疗慢性鼻炎。这是一项针对成年慢性鼻炎患者进行鼻后神经消融的前瞻性、多中心、单臂临床研究。主要疗效终点是6个月随访时反射性总鼻症状评分(rTNSS)的变化。额外的评估包括咽鼓管功能障碍问卷(ETDQ - 7)、鼻阻塞症状评估(NOSE)和小型鼻结膜炎生活质量问卷(mini - RQLQ)。主要安全终点是相关严重不良事件的发生率。80名入组参与者中有79名完成了6个月的随访。观察到rTNSS(-4.2)、ETDQ - 7(-1.2)、NOSE(-33.5)和mini - RQLQ(-1.8;所有均P <.0001)的平均变化有统计学意义的改善。变应性和非变应性鼻炎亚组在所有评估中均显示出显著改善(P <.0001),亚组间无显著差异。较高的基线rTNSS与随访时更大的改善相关。报告了1例鼻出血严重不良事件。本研究结果证明了一种多点、阻抗控制的射频消融装置治疗慢性鼻炎的有效性和安全性。在rTNSS、ETDQ - 7、NOSE和mini - RQLQ评估中观察到显著改善。www.clinicaltrials.gov。唯一标识符NCT05591989。

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