Joo Hye Ah, Park Sung-Min, Kim Yehree, Lee Dong Kyu, Lee Yun Ji, Choi Yeonjoo, Kang Woo Seok, Ahn Joong Ho, Chung Jong Woo, Chung Won-Ho, Koo Ja-Won, Park Hong Ju
Department of Otorhinolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.
Clin Exp Otorhinolaryngol. 2025 Aug;18(3):234-241. doi: 10.21053/ceo.2024.00281. Epub 2025 Feb 4.
Balloon eustachian tuboplasty (BET) is an emerging treatment for dilatory eustachian tube (ET) dysfunction, yet its efficacy in patients with chronic suppurative otitis media (COM) combined with ET dysfunction remains unclear. This trial aimed to evaluate the efficacy and safety of BET versus medical management (MM) alone in adult patients with COM and chronic dilatory ET dysfunction, as defined by a failed Valsalva maneuver.
This prospective, multicenter, randomized controlled trial enrolled 116 participants (121 ears) between January 2021 and June 2023. Participants were randomly assigned (1:1) to receive either BET combined with MM or MM alone (fluticasone furoate nasal steroid spray). The primary short-term outcome was the normalization of the Valsalva maneuver at 8 weeks, while secondary outcomes included improvements in Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) scores and reductions in the air-bone gap (ABG) measured at 8 weeks. Adverse events were monitored in both groups throughout the follow-up period.
Of the 116 participants (121 ears), 60 participants (62 ears) received BET and 56 participants (59 ears) received MM alone. There were no significant differences in demographics, baseline characteristics, ETDQ-7 scores, bone conduction thresholds, or ABG between the groups. In the BET group, 46.8% of ears (29/62) achieved a successful Valsalva maneuver compared with 15.3% of ears (9/59) in the MM-only group (P<0.001). The BET group exhibited greater subjective symptom improvement, with an average ETDQ-7 score reduction of -6.2±9.4 compared to -2.6±8.6 in the MM-only group (P=0.028). Additionally, the ABG decreased more significantly in the BET group (-5.8±11.4 dB HL) than in the MM-only group (-1.2±10.5 dB HL) (P=0.023). No serious procedure- or device-related adverse events were observed during the 8-week follow-up.
This trial demonstrates that BET combined with MM is superior to MM alone in treating dilatory ET dysfunction in patients with COM, while also maintaining a favorable safety profile.
球囊咽鼓管成形术（BET）是一种治疗咽鼓管（ET）扩张功能障碍的新兴疗法，但其对慢性化脓性中耳炎（COM）合并ET功能障碍患者的疗效尚不清楚。本试验旨在评估BET与单纯药物治疗（MM）相比，对患有COM和慢性扩张性ET功能障碍（通过瓦尔萨尔瓦动作失败定义）的成年患者的疗效和安全性。
本前瞻性、多中心、随机对照试验在2021年1月至2023年6月期间招募了116名参与者（121只耳朵）。参与者被随机分配（1:1）接受BET联合MM或单纯MM（糠酸氟替卡松鼻用类固醇喷雾剂）。主要短期结局是8周时瓦尔萨尔瓦动作恢复正常，次要结局包括咽鼓管功能障碍问卷-7（ETDQ-7）评分的改善以及8周时气骨导差（ABG）的降低。在整个随访期间对两组的不良事件进行监测。
116名参与者（121只耳朵）中，60名参与者（62只耳朵）接受了BET，56名参与者（59只耳朵）接受了单纯MM。两组在人口统计学、基线特征、ETDQ-7评分、骨导阈值或ABG方面无显著差异。在BET组中，46.8%的耳朵（29/62）瓦尔萨尔瓦动作成功，而单纯MM组为15.3%的耳朵（9/59）（P<0.001）。BET组主观症状改善更明显，ETDQ-7评分平均降低-6.2±9.4，而单纯MM组为-2.6±8.6（P=0.028）。此外，BET组的ABG下降幅度（-5.8±11.4 dB HL）比单纯MM组（-1.2±10.5 dB HL）更显著（P=0.023）。在8周的随访期间未观察到严重的手术或器械相关不良事件。
本试验表明，BET联合MM在治疗COM患者的扩张性ET功能障碍方面优于单纯MM，同时保持了良好的安全性。
