Serra A, Spinato G, Spinato R, Conti A, Licciardello L, Di Luca M, Campione G, Tonoli G, Politi D, Castro V, Maniaci A, Maiolino L, Cocuzza S
ENT Department of University of Catania, Italy
ENT Department, Rovigo Provincial Hospital, Italy
J Biol Regul Homeost Agents. 2017 Jul-Sep;31(3):803-809.
The aim of this study was to assess the clinical experience of three Italian centers using the third generation Provox Vega prosthesis, in terms of device life and voice outcome, comparing the results with the second generation Provox 2 prosthesis in the same sample. A prospective multicenter crossover study was performed in three phases. In the first phase we performed a reassessment, for enrollment purposes, of patients who were categorized into four different groups [normal – group A; radio-treated – group B; gastroesophageal reflux disease (GERD) – group C; and elderly subjects – group D]. In the second and third phases, all patients were monitored for prosthetic device life and assessed for objective and subjective voice characteristics after introducing Provox 2 and Provox Vega prostheses. In patients with Provox 2 prosthesis, the mean life was 165 days in group A, 148 days in group B, 91 days in group C and 188 days in group D. In Provox Vega patients, mean in situ prosthesis life was 213 days in group A, 182 days in group B, 118 days in group C and 227 days in group D. The perceptual voice data showed a better rating across all parameters for the Provox Vega samples compared to those of Provox 2. In this paper, we report the first multicenter crossover study comparing different prosthetic models in the same patients, categorized in relation to different typologies of tracheoesophageal rehabilitative status. Result analyses confirmed an optimal stability of the Provox Vega compared to the Provox 2, in terms of device life and perceptual voice parameters.
本研究旨在评估意大利三个中心使用第三代Provox Vega假体的临床经验，包括装置寿命和语音结果，并将结果与同一样本中第二代Provox 2假体进行比较。进行了一项前瞻性多中心交叉研究，分为三个阶段。在第一阶段，为了招募目的，我们对被分为四个不同组别的患者进行了重新评估[正常组 - A组；接受放疗组 - B组；胃食管反流病（GERD）组 - C组；老年受试者组 - D组]。在第二和第三阶段，在植入Provox 2和Provox Vega假体后，对所有患者的假体装置寿命进行监测，并评估客观和主观语音特征。使用Provox 2假体的患者中，A组的平均寿命为165天，B组为148天，C组为91天，D组为188天。使用Provox Vega假体的患者中，A组的假体原位平均寿命为213天，B组为182天，C组为118天，D组为227天。感知语音数据显示，与Provox 2相比，Provox Vega样本在所有参数上的评分更高。在本文中，我们报告了第一项在同一患者中比较不同假体模型的多中心交叉研究，这些患者根据不同类型的气管食管康复状态进行分类。结果分析证实，与Provox 2相比，Provox Vega在装置寿命和感知语音参数方面具有最佳稳定性。
