Oto-Rhino-Laryngology-Head and Neck Surgery Department, Montpellier University, CHU Gui de Chauliac, 80 Avenue Augustin Fliche, 34295, Montpellier, France.
Oto-Rhino-Laryngology, Head and Neck Surgery Department, Saint-Etienne University, Hôpital Nord, Saint Etienne, France.
Eur Arch Otorhinolaryngol. 2023 Mar;280(3):1101-1109. doi: 10.1007/s00405-022-07578-2. Epub 2022 Aug 6.
Balloon dilatation of the Eustachian tube (BDET) is an option for treating chronic obstructive Eustachian tube dysfunction (COETD). In this prospective multicentric study, the main objective was to evaluate the results of BDET in unilateral COETD refractory to medical treatment.
Adults with unilateral COETD whose Eustachian Tube Score (ETS) was less than 5 despite medical pressure therapy were included. The primary endpoint was the change in ETS measured at 2, 6, and 12 months after BDET. Secondary objectives were the evolution of clinical symptoms assessed by the Eustachian Tube Questionnaire (ETDQ-7), audiometry, tympanometry, and otoscopy changes after BDET.
Twenty-eight patients were included between May 2014 and December 2017 and were treated with BDET without adverse effects in three different referral centers. Population's median age was 52 (Q25; Q75: 24, 82) years. The median follow-up time was 381 (Q25; Q75: 364; 418) days. The median ETS was 2 (Q25; Q75: 1; 4) before BDET. There was a significant improvement in ETS at 2 and 6 months and 1 year after BDET (score at 1 year: 6 (Q25; Q75: 2; 8) (p < 0.0001)). There was a significant, sustained improvement in the ETDQ-7 with a score of 4.21 (Q25; Q75-3.50; 4.79) before BDET and 3.43 (Q25; Q75-2.43; 4.14) (p = 0.0012) at 1 year. There was a suggestive improvement in tympanometry results at 1 year (p = 0.025).
BDET provides an improvement in symptoms and objective measures assessed at 1 year in patients with COETD who have failed medical treatment.
NCT02123277 (April 25, 2014).
咽鼓管球囊扩张术（BDET）是治疗慢性阻塞性咽鼓管功能障碍（COETD）的一种选择。在这项前瞻性多中心研究中，主要目的是评估 BDET 对单侧 COETD 治疗无效的患者的疗效。
纳入单侧 COETD 患者，这些患者尽管接受了药物压力治疗，但咽鼓管评分（ETS）仍低于 5。主要终点是 BDET 后 2、6 和 12 个月时 ETS 的变化。次要目标是通过咽鼓管问卷（ETDQ-7）、听力计、鼓室压图和耳镜检查评估 BDET 后的临床症状演变。
2014 年 5 月至 2017 年 12 月期间，在三个不同转诊中心，28 名患者接受了 BDET 治疗，无不良反应。患者的中位年龄为 52 岁（四分位距 25%，75%：24，82）。中位随访时间为 381 天（四分位距 25%，75%：364，418）。BDET 前 ETS 中位数为 2（四分位距 25%，75%：1，4）。BDET 后 2、6 和 1 年，ETS 显著改善（1 年时评分：6（四分位距 25%，75%：2，8）（p<0.0001））。ETDQ-7 评分显著且持续改善，BDET 前评分为 4.21（四分位距 25%，75%：3.50，4.79），1 年后评分为 3.43（四分位距 25%，75%：2.43，4.14）（p=0.0012）。1 年后，鼓室压图结果提示有所改善（p=0.025）。
在药物治疗无效的 COETD 患者中，BDET 在 1 年时可改善症状和客观评估结果。
NCT02123277（2014 年 4 月 25 日）。
Zotero 插件