Práctica Médica Grupal en Otorrinolaringología, Centro Médico ABC, Campus Santa Fe. Avenida Carlos Graef Fernández 154, Colonia Tlaxala, Cuajimalpa 05330, Ciudad de México, Mexico.
Departamento de Otorrinolaringología, Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Calzada de Tlalpan 4502, Colonia Sección XVI, Tlalpan 14080, Ciudad de México, Mexico.
Acta Otorrinolaringol Esp (Engl Ed). 2022 Mar-Apr;73(2):82-88. doi: 10.1016/j.otoeng.2020.12.001.
After surgical resection of papilloma, adjuvant therapy may be recommended for the control of recurrent respiratory papillomatosis (RRP). As the efficacy of adjuvant therapy remains unproven, the aim of this study was to compare the efficacy of cidofovir versus bevacizumab used as adjuvant therapies for the control of RRP.
This randomized, double-blind, placebo-controlled pilot study was performed in a national respiratory disease referral centre. Patients with RRP were recruited prospectively and were divided into juvenile or adult RRP. Participants were randomly assigned to receive adjuvant therapy with cidofovir, bevacizumab or placebo. The study drug or placebo was administered after direct microlaryngoscopy with papilloma resection using cold instruments. The Derkay severity score and the Voice Handicap Index (VHI) were assessed at 3-6-week intervals, for a total of 3 visits. Follow-up included VHI and Derkay score assessments at 2-month intervals over the course of one year. Annual rates before and after surgical treatment were compared.
Five children and 11 adults were enrolled in the study. After one year, the group treated with cidofovir had a significant decrease in Derkay score (p=.027). No difference between treatment arms was observed in the annual surgery rate. There was a significant decrease in the VHI score in all treatment groups (p<.001), and no significant difference was observed between groups (p=.32).
While we observed a significant decrease in RRP severity with intralesional cidofovir, we were unable to provide proof of efficacy of intralesional bevacizumab.
gov Identifier: NCT02555800.
在切除乳头状瘤后，可能会建议辅助治疗以控制复发性呼吸道乳头状瘤病（RRP）。由于辅助治疗的疗效尚未得到证实，本研究旨在比较更昔洛韦与贝伐单抗作为辅助治疗控制 RRP 的疗效。
这是一项在国家呼吸疾病转诊中心进行的随机、双盲、安慰剂对照的初步研究。前瞻性招募 RRP 患者，并将其分为青少年或成年 RRP。参与者被随机分配接受更昔洛韦、贝伐单抗或安慰剂辅助治疗。研究药物或安慰剂在使用冷器械直接显微镜检查切除乳头状瘤后给药。在总共 3 次就诊中，每 3-6 周评估一次 Derkay 严重程度评分和语音障碍指数（VHI）。随访包括在一年的过程中每两个月进行一次 VHI 和 Derkay 评分评估。比较手术前后的年度发生率。
研究纳入了 5 名儿童和 11 名成年人。一年后，接受更昔洛韦治疗的组 Derkay 评分显著降低（p=.027）。治疗组之间的年手术率无差异。所有治疗组的 VHI 评分均显著降低（p<.001），但组间无显著差异（p=.32）。
虽然我们观察到局部注射更昔洛韦可显著降低 RRP 严重程度，但我们无法提供局部注射贝伐单抗疗效的证据。
gov 标识符：NCT02555800。
