创新性多点阻抗控制射频消融术治疗慢性鼻炎后的临床疗效。

Greg E Davis, Randall A Ow, David M Yen, Ellen M O'Malley, Anthony G Del Signore
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引用次数: 0

摘要

目的:慢性鼻炎严重影响患者的生活质量。我们对用于治疗慢性鼻炎的新型多点阻抗控制射频消融设备进行了评估。研究方法这是一项前瞻性、多中心、单臂临床研究,针对慢性鼻炎成人患者的后鼻神经消融术。主要疗效终点是随访 6 个月时反映性鼻症状总评分(rTNSS)的变化。其他评估包括咽鼓管功能障碍问卷(ETDQ-7)、鼻阻塞症状评估(NOSE)和迷你鼻结膜炎生活质量问卷(mini-RQLQ)。主要安全性终点是相关严重不良事件的发生率。研究结果80 名注册参与者中有 79 人完成了为期 6 个月的随访。rTNSS(-4.2)、ETDQ-7(-1.2)、NOSE(-33.5)和迷你 RQLQ(-1.8;P < .0001)的平均变化均有统计学意义的明显改善。过敏性鼻炎亚组和非过敏性鼻炎亚组在所有评估中均有显著改善(P < .0001),亚组之间无明显差异。基线 rTNSS 越高,随访时的改善程度越大。报告了一起鼻衄的严重不良事件。结论:这项研究结果证明了多点阻抗控制射频消融设备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。研究注册:www.clinicaltrials.gov。唯一标识符 NCT05591989。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical Outcomes After Innovative Multipoint Impedance-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve for Treatment of Chronic Rhinitis.

Objective: 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. Methods: 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. Results: 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; P < .0001 for all). Allergic and nonallergic rhinitis subgroups demonstrated significant improvement in all assessments (P < .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. Conclusions: 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.Study registration: www.clinicaltrials.gov. Unique identifier NCT05591989.

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