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经温度控制的鼻后神经射频消融术(RhinAer)治疗慢性鼻炎的临床和生活质量结局。

Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis.

机构信息

Department of Head and Neck Surgery, UCLA David Geffen School of Medicine, Los Angeles, CA, USA.

Advanced ENT and Allergy, Louisville, KY, USA.

出版信息

Am J Rhinol Allergy. 2022 Nov;36(6):747-754. doi: 10.1177/19458924221109987. Epub 2022 Jul 11.

Abstract

BACKGROUND

Temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN; RhinAer) is a minimally invasive treatment option for patients with chronic rhinitis.

OBJECTIVE

To determine clinical outcomes and quality of life (QoL) following TCRF neurolysis of the PNN.

METHODS

A prospective single-arm study of 129 patients with chronic rhinitis at 16 medical centers in the United States and Germany.

RESULTS

The mean 24-h reflective total nasal symptom score (rTNSS) improved from 7.8 (95% CI, 7.5-8.1) at baseline to 3.6 (95% CI, 3.2-4.0) at 3 months and continued to improve to 2.9 (95% CI, 2.5-3.3) at 6 months ( < .001 comparing follow-up to baseline and  = .002 comparing 3 and 6 months). This represents 53.8% improvement over baseline at 3 months and 62.8% improvement at 6 months. Rhinorrhea, congestion, sneezing, and itching subscores and postnasal drip and cough scores were all significantly improved over baseline at both timepoints. At 3 months, 76.2% (95% CI, 68.1%-82.8%) of patients achieved a minimal clinically important difference of ≥30% improvement in rTNSS over baseline and the percentage was higher at 6 months (83.5% [95% CI, 75.8%-89.0%]). At 3 months, 80.3% (95% CI, 72.6%-86.3%) reported a minimal clinically important difference of ≥0.4-point improvement in the mini rhinoconjunctivitis quality of life questionnaire score, and the percentage was higher at 6 months; 87.7% (95% CI, 80.7%-92.4%). There were no serious adverse events with a relationship to the device/procedure reported through 6 months.

CONCLUSION

In this large, multicenter study, TCRF neurolysis of the PNN was safe and resulted in a significant reduction in rhinitis symptom burden at 3 months that was sustained/improved through 6 months. The majority of patients reported a clinically relevant improvement in QoL at 3 and 6 months postprocedure.

摘要

背景

经鼻内温度控制射频(TCRF)神经切断术(RhinAer)是一种治疗慢性鼻炎的微创选择。

目的

确定经鼻内温度控制射频(TCRF)神经切断术(RhinAer)治疗后患者的临床疗效和生活质量(QoL)。

方法

在美国和德国的 16 个医学中心进行的一项前瞻性单臂研究,共纳入 129 例慢性鼻炎患者。

结果

24 小时反射性总鼻症状评分(rTNSS)从基线时的 7.8(95%CI,7.5-8.1)改善至 3 个月时的 3.6(95%CI,3.2-4.0),并持续改善至 6 个月时的 2.9(95%CI,2.5-3.3)(与基线相比,均 < 0.001;与 3 个月相比, = 0.002)。这代表 3 个月时与基线相比有 53.8%的改善,6 个月时为 62.8%。鼻塞、充血、打喷嚏、瘙痒的亚评分以及后鼻滴注和咳嗽评分在这两个时间点均较基线显著改善。在 3 个月时,76.2%(95%CI,68.1%-82.8%)的患者实现了 rTNSS 较基线改善≥30%的最小临床重要差异,6 个月时该比例更高(83.5%[95%CI,75.8%-89.0%])。在 3 个月时,80.3%(95%CI,72.6%-86.3%)的患者报告在 mini rhinoconjunctivitis 生活质量问卷评分中改善≥0.4 分的最小临床重要差异,6 个月时该比例更高(87.7%[95%CI,80.7%-92.4%])。在 6 个月时,没有与设备/程序相关的严重不良事件报告。

结论

在这项大型、多中心研究中,经鼻内温度控制射频(TCRF)神经切断术(RhinAer)治疗安全,可显著降低 3 个月时的鼻炎症状负担,并且在 6 个月时得到维持/改善。大多数患者在术后 3 个月和 6 个月时报告生活质量有临床意义的改善。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdd8/9548948/37f4bc0e57a5/10.1177_19458924221109987-fig1.jpg

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