Yiwu Central Hospital, Yiwu City, Zhejiang Province, China.
Changzheng Hospital, Naval Medical University Shanghai, Shanghai City, China.
Am J Rhinol Allergy. 2022 May;36(3):297-306. doi: 10.1177/19458924211057353. Epub 2021 Nov 19.
The objective of this trial was to compare outcomes of electrocoagulation tuboplasty and continued medical therapy for treating persistent Eustachian tube dysfunction (ETD) with hypertrophic mucosa disease in the Eustachian tube (ET) orifice.
Prospective, case-control trial.
Patients with persistent ETD were recruited and allocated to electrocoagulation tuboplasty and continued medical therapy groups. The ETD questionnaire-7 (ETDQ-7) score and objective parameters were compared between the groups at 6 and 12 months.
The proportion of patients with a decrease in ETDQ-7 scores was greater in the electrocoagulation group than in the medical therapy group at the 6-month follow-up (53.49% and 34.38%, respectively; = .158), but the difference was not statistically significant. However, at the 12-month follow-up, there was a significantly higher proportion of patients with a decrease in ETDQ-7 scores in the electrocoagulation group (88.37% and 40.63%, respectively; = .001). Additionally, a significant difference was observed between the groups in terms of the proportion of patients who improved 12 months after the treatment (tympanometry: 72.09% and 9.38%, respectively; = .001; air-bone gap: 79.07% and 25.00%, respectively; = .001; tympanic membrane status: 62.79% and 0.00%, respectively). In addition, the proportion of patients with improvements in the ET inflammation score was significantly different between the groups at 6-month (67.44% and 34.38%, respectively; = .009) and 12-month (93.02% and 34.38%; = .001) follow-ups. No device- or procedure-related serious adverse events were reported in any patients.
Electrocoagulation Eustachian tuboplasty appears to be a safe and feasible procedure for adult persistent ETD with hypertrophic mucosa disease in the ET orifice, and is superior to continued medical management alone. The improvements in ETDQ-7 and objective parameters persisted for 12 months.
本试验旨在比较电凝咽鼓管成形术和继续药物治疗对咽鼓管（ET）口肥厚性黏膜病变的持续性咽鼓管功能障碍（ETD）的疗效。
前瞻性病例对照试验。
招募持续性 ETD 患者，并将其分配到电凝咽鼓管成形术和继续药物治疗组。在 6 个月和 12 个月时，比较两组 ETDQ-7（ETDQ-7）评分和客观参数。
在 6 个月随访时，电凝组 ETDQ-7 评分降低的患者比例大于药物治疗组（分别为 53.49%和 34.38%；=0.158），但差异无统计学意义。然而，在 12 个月随访时，电凝组 ETDQ-7 评分降低的患者比例明显更高（分别为 88.37%和 40.63%；=0.001）。此外，治疗 12 个月后，两组患者改善的比例存在显著差异（鼓室压：分别为 72.09%和 9.38%；=0.001；气骨导差：分别为 79.07%和 25.00%；=0.001；鼓膜状态：分别为 62.79%和 0.00%）。此外，两组患者在 6 个月（分别为 67.44%和 34.38%；=0.009）和 12 个月（分别为 93.02%和 34.38%；=0.001）随访时的 ET 炎症评分改善比例也存在显著差异。在任何患者中，均未报告与设备或程序相关的严重不良事件。
电凝咽鼓管成形术似乎是治疗 ET 口肥厚性黏膜病变的成人持续性 ETD 的一种安全可行的方法，优于单纯药物治疗。ETDQ-7 和客观参数的改善持续了 12 个月。
