1 Weill Cornell Medical College, New York, New York, USA.
2 Department of Otolaryngology and Communication Enhancement, Boston Children's Hospital, Boston, Massachusetts, USA.
Otolaryngol Head Neck Surg. 2019 Apr;160(4):687-694. doi: 10.1177/0194599818821938. Epub 2019 Jan 8.
Obstructive eustachian tube dysfunction (OETD) affects up to 5% of adults; however, available treatment strategies have limitations. It was previously reported that balloon dilation of the eustachian tube (BDET) with the eustachian tube balloon catheter + medical management (MM) results in a significantly higher proportion of subjects with normalized tympanograms versus MM alone at 6- and 24-week follow-up. The current analysis extends these initial findings by investigating the durability of BDET + MM treatment outcomes through 52 weeks.
Prospective cohort follow-up study from the treatment group in a previously reported multicenter randomized controlled trial.
Twenty-one investigational sites across the United States.
Here we report on secondary and exploratory endpoints for patients with OETD who previously failed MM and were randomized to the BDET + MM cohort. Analyses of tympanogram outcomes are reported by ear, unless specified otherwise, as a more accurate measure of durability of the procedure over time.
Among subjects randomized to BDET + MM, the overall number with normalized tympanograms and ETDQ-7 scores (Eustachian Tube Dysfunction Questionnaire-7) remained comparable to those reported at 6- versus 52-week follow-up: tympanograms, 73 of 143 (51.0%) versus 71 of 128 (55.5%); ETDQ-7, 79 of 142 (55.6%) versus 71 of 124 (57.3%). The overall number of ears with normalized tympanograms also remained comparable, with 117 of 204 (57%) versus 119 of 187 (63.6%).
The present study suggests that the beneficial effects of BDET + MM on tympanogram normalization and symptoms of subjects with refractory OETD demonstrate significant durability that is clinically relevant through 52 weeks.
阻塞性咽鼓管功能障碍（OETD）影响高达 5%的成年人；然而，现有的治疗策略存在局限性。先前有报道称，使用咽鼓管球囊导管（eustachian tube balloon catheter）扩张咽鼓管（BDET）联合药物治疗（MM）在 6 周和 24 周随访时，与 MM 单独治疗相比，有更多的患者鼓室图正常。本分析通过 52 周的随访，进一步研究了 BDET + MM 治疗结果的持久性，扩展了这些初步发现。
先前报道的多中心随机对照试验中治疗组的前瞻性队列随访研究。
美国 21 个研究地点。
这里报告的是先前 MM 治疗失败且随机分配到 BDET + MM 组的 OETD 患者的次要和探索性终点。除非另有说明，否则通过耳鼓室图结果进行分析，因为这是一种更准确的方法，可以随着时间的推移衡量该程序的持久性。
在随机分配到 BDET + MM 的受试者中，鼓室图正常和 ETDQ-7 评分（咽鼓管功能障碍问卷-7）正常的患者总数与 6 周和 52 周随访时报告的结果相似：鼓室图，143 例中有 73 例（51.0%）与 128 例中有 71 例（55.5%）；ETDQ-7，142 例中有 79 例（55.6%）与 124 例中有 71 例（57.3%）。鼓室图正常的耳朵总数也相似，204 例中有 117 例（57%）与 187 例中有 119 例（63.6%）。
本研究表明，对于难治性 OETD 患者，BDET + MM 对鼓室图正常化和症状的有益影响具有显著的持久性，在 52 周时具有临床意义。
