咽鼓管扩张术治疗扩张功能障碍的随机对照试验。
Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial.
作者信息
Poe Dennis, Anand Vijay, Dean Marc, Roberts William H, Stolovitzky Jose Pablo, Hoffmann Karen, Nachlas Nathan E, Light Joshua P, Widick Mark H, Sugrue John P, Elliott C Layton, Rosenberg Seth I, Guillory Paul, Brown Neil, Syms Charles A, Hilton Christopher W, McElveen John T, Singh Ameet, Weiss Raymond L, Arriaga Moises A, Leopold John P
机构信息
Boston Children's Hospital, Boston, Massachusetts.
Weill Cornell Medical College, Department of Otolaryngology and Head and Neck Surgery, New York, New York.
出版信息
Laryngoscope. 2018 May;128(5):1200-1206. doi: 10.1002/lary.26827. Epub 2017 Sep 20.
OBJECTIVES/HYPOTHESIS: To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction.
STUDY DESIGN
In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone.
METHODS
The primary endpoint was normalization of tympanogram at 6 weeks. Additional endpoints were normalization of Eustachian Tube Dysfunction Questionaire-7 symptom scores, positive Valsalva maneuver, mucosal inflammation, and safety.
RESULTS
Primary efficacy results demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone. Tympanogram normalization at 6-week follow-up was observed in 51.8% (72/139) of investigational patients versus 13.9% (10/72) of controls (P < .0001). Tympanogram normalization in the treatment group was 62.2% after 24 weeks. Normalization of Eustachian Tube Dysfunction Questionaire-7 Symptom scores at 6-week follow-up was observed in 56.2% (77/137) of investigational patients versus 8.5% (6/71) controls (P < .001). The investigational group also demonstrated substantial improvement in both mucosal inflammation and Valsalva maneuver at 6-week follow-up compared to controls. No device- or procedure-related serious adverse events were reported for those who underwent balloon dilation of the Eustachian tube.
CONCLUSIONS
This study demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone to treat Eustachian tube dilatory dysfunction in adults.
LEVEL OF EVIDENCE
1b. Laryngoscope, 128:1200-1206, 2018.
目的/假设：评估使用咽鼓管球囊导管进行咽鼓管球囊扩张术联合药物治疗作为咽鼓管扩张功能障碍的治疗方法。
研究设计
在这项前瞻性、多中心、随机对照试验中，我们以2:1的比例将22岁及以上对药物治疗无效的咽鼓管扩张功能障碍患者分配为接受使用球囊导管进行咽鼓管球囊扩张术联合药物治疗或仅接受药物治疗。
方法
主要终点是6周时鼓室图正常化。其他终点包括咽鼓管功能障碍问卷-7症状评分正常化、瓦尔萨尔瓦动作阳性、黏膜炎症和安全性。
结果
主要疗效结果表明，与单纯药物治疗相比，使用球囊导管进行咽鼓管球囊扩张术联合药物治疗具有优越性。在6周随访时，139例研究患者中有51.8%（72/139）的鼓室图正常化，而对照组为13.9%（10/72）（P <.0001）。治疗组在24周后鼓室图正常化率为62.2%。在6周随访时，137例研究患者中有56.2%（77/137）的咽鼓管功能障碍问卷-7症状评分正常化，而对照组为8.5%（6/71）（P <.001）。与对照组相比，研究组在6周随访时黏膜炎症和瓦尔萨尔瓦动作也有显著改善。接受咽鼓管球囊扩张术的患者未报告与器械或操作相关的严重不良事件。
结论
本研究表明，与单纯药物治疗相比，使用球囊导管进行咽鼓管球囊扩张术联合药物治疗在治疗成人咽鼓管扩张功能障碍方面具有优越性。
证据级别
1b。《喉镜》，2018年，第128卷，第1200 - 1206页。
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