Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68161 Mannheim, Germany.
Eur Arch Otorhinolaryngol. 2013 Feb;270(2):595-601. doi: 10.1007/s00405-012-2088-2. Epub 2012 Jun 28.
The objective of the study was to assess the short-term efficacy of radiofrequency volumetric tissue reduction (RFVTR) of the inferior turbinates in patients with nasal obstruction caused by turbinate hypertrophy. The study is a prospective, randomized, single-blinded, placebo-controlled, crossover trial. A total of 22 patients (age range 21-72 years; median age 41 years) were randomized into two treatment arms. Using a bipolar radiofrequency system, the first group (VP-group) received RFVTR (verum = V) first (at t1) followed by a placebo treatment (P) 6-8 weeks later (at t2). The PV-group was treated with placebo first at t1 and received RFVTR at t2. Subjects in both groups underwent identical procedures in an office-based setting. Delivery of radiofrequency energy was the only difference between the two groups. The outcome measures assessed were rhinomanometry, physician's evaluation of the degree of hypertrophy of the inferior turbinates and patients' estimation of nasal obstruction. Physician and patient evaluations were documented using a score ranging from 0 = none to 4 = severe. Evaluation was performed 6-8 weeks after every intervention. No intraoperative or postoperative complications occurred. Inferior turbinate hypertrophy improved significantly in both groups after RFVTR was performed (VP-group: p < 0.001; PV-group: p = 0.002). Nasal obstruction also decreased only after RFVTR (VP-group: p = 0.004, PV-group: p = 0.002). This study confirmed the safety of bipolar RFVTR as an office-based treatment of nasal obstruction due to inferior turbinate hypertrophy. We could prove that RFVTR is superior to placebo for reduction in turbinate hypertrophy and subjective improvement in nasal obstruction. To our knowledge, this is the first level I study proving the short-term efficacy of a bipolar radiofrequency system.
本研究旨在评估射频鼻甲容积减少术（RFVTR）治疗下鼻甲肥大引起的鼻塞的短期疗效。该研究为前瞻性、随机、单盲、安慰剂对照、交叉试验。共有 22 名患者（年龄 21-72 岁；中位年龄 41 岁）被随机分为两组。第一组（VP 组）使用双极射频系统，首先接受 RFVTR（真=V）治疗（t1），然后在 6-8 周后（t2）接受安慰剂治疗。PV 组首先在 t1 时接受安慰剂治疗，然后在 t2 时接受 RFVTR 治疗。两组患者均在门诊环境下接受相同的治疗。两组之间唯一的区别是射频能量的传递。评估的结果包括鼻测压、医生评估下鼻甲肥大程度和患者对鼻塞的估计。医生和患者的评估使用从 0=无到 4=严重的评分进行记录。每次干预后 6-8 周进行评估。没有发生术中或术后并发症。RFVTR 后，两组患者的下鼻甲肥大均明显改善（VP 组：p<0.001；PV 组：p=0.002）。只有在进行 RFVTR 后，鼻塞才会减轻（VP 组：p=0.004，PV 组：p=0.002）。这项研究证实了双极 RFVTR 作为治疗下鼻甲肥大引起的鼻塞的门诊治疗方法的安全性。我们可以证明，RFVTR 在减少鼻甲肥大和主观改善鼻塞方面优于安慰剂。据我们所知，这是第一项证明双极射频系统短期疗效的 I 级研究。
