{"title":"双腔咽鼓管球囊导管安全性和有效性的多中心、单臂、客观性能标准对照临床研究。","authors":"Yu Si, Fan Shu, Wei Liu, Yusong Jiang, Yaodong Xu, Yongkang Ou, Haidi Yang, Hao Xiong, Maojin Liang, Cuiping Deng, Zhiyin Lu, Yan Luo, Jun Shen, Hongzheng Zhang, Zhigang Zhang, Suijun Chen","doi":"10.1097/MAO.0000000000004312","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>To prospectively evaluate the technical efficacy and safety of the double-lumen eustachian tube (ET) balloon catheter in patients with ET dysfunction.</p><p><strong>Methods: </strong>Patients who were diagnosed with ET dysfunction and needed balloon eustachian tuboplasty (BET) were prospectively enrolled. A double-lumen ET balloon catheter was used to dilate the ET and inject medicine. Efficacy results were assessed by the injection channel patency (ICP) rate, the injection reached the expected site (IRES) rate, and the improvement in eustachian tube function was evaluated by the seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score. Safety results were assessed in terms of adverse events and device defects.</p><p><strong>Results: </strong>BET was successfully attempted in 87 patients from April 2022 to August 2022 at two academic medical centers in China (01, 02). The ICP rate was 100%, and the IRES rate was 88.51%. The overall ETDQ-7 score was significantly reduced ( p < 0.001) postsurgically at both centers. There were no major complications or device defects.</p><p><strong>Conclusion: </strong>The double-lumen ET balloon catheter is technically effective and safe for the treatment of ET dysfunction.</p>","PeriodicalId":19732,"journal":{"name":"Otology & Neurotology","volume":null,"pages":null},"PeriodicalIF":1.9000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A Multicenter, Single-Arm, Objective Performance Criteria-Controlled Clinical Study of the Safety and Efficacy of the Double-Lumen Eustachian Tube Balloon Catheter.\",\"authors\":\"Yu Si, Fan Shu, Wei Liu, Yusong Jiang, Yaodong Xu, Yongkang Ou, Haidi Yang, Hao Xiong, Maojin Liang, Cuiping Deng, Zhiyin Lu, Yan Luo, Jun Shen, Hongzheng Zhang, Zhigang Zhang, Suijun Chen\",\"doi\":\"10.1097/MAO.0000000000004312\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>To prospectively evaluate the technical efficacy and safety of the double-lumen eustachian tube (ET) balloon catheter in patients with ET dysfunction.</p><p><strong>Methods: </strong>Patients who were diagnosed with ET dysfunction and needed balloon eustachian tuboplasty (BET) were prospectively enrolled. A double-lumen ET balloon catheter was used to dilate the ET and inject medicine. Efficacy results were assessed by the injection channel patency (ICP) rate, the injection reached the expected site (IRES) rate, and the improvement in eustachian tube function was evaluated by the seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score. Safety results were assessed in terms of adverse events and device defects.</p><p><strong>Results: </strong>BET was successfully attempted in 87 patients from April 2022 to August 2022 at two academic medical centers in China (01, 02). The ICP rate was 100%, and the IRES rate was 88.51%. The overall ETDQ-7 score was significantly reduced ( p < 0.001) postsurgically at both centers. There were no major complications or device defects.</p><p><strong>Conclusion: </strong>The double-lumen ET balloon catheter is technically effective and safe for the treatment of ET dysfunction.</p>\",\"PeriodicalId\":19732,\"journal\":{\"name\":\"Otology & Neurotology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2024-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Otology & Neurotology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/MAO.0000000000004312\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/8/29 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Otology & Neurotology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/MAO.0000000000004312","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/29 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景：前瞻性评估双腔咽鼓管（ET）球囊导管在咽鼓管功能障碍患者中的技术有效性和安全性：前瞻性评估双腔咽鼓管（ET）球囊导管在咽鼓管功能障碍患者中的技术有效性和安全性：方法： 对确诊为耳鼻喉功能障碍并需要进行球囊咽鼓管成形术（BET）的患者进行前瞻性研究。使用双腔咽鼓管球囊导管扩张咽鼓管并注入药物。疗效通过注射通道通畅率（ICP）、注射到达预期部位率（IRES）进行评估，咽鼓管功能改善情况通过七项咽鼓管功能障碍问卷（ETDQ-7）评分进行评估。根据不良事件和设备缺陷对安全性进行了评估：2022年4月至2022年8月，中国两家学术医疗中心（01、02）成功为87名患者进行了BET尝试。ICP率为100%，IRES率为88.51%。两家中心的术后 ETDQ-7 总分均显著降低（P < 0.001）。没有重大并发症或设备缺陷：结论：双腔 ET 球囊导管治疗 ET 功能障碍在技术上是有效和安全的。
A Multicenter, Single-Arm, Objective Performance Criteria-Controlled Clinical Study of the Safety and Efficacy of the Double-Lumen Eustachian Tube Balloon Catheter.
Background: To prospectively evaluate the technical efficacy and safety of the double-lumen eustachian tube (ET) balloon catheter in patients with ET dysfunction.
Methods: Patients who were diagnosed with ET dysfunction and needed balloon eustachian tuboplasty (BET) were prospectively enrolled. A double-lumen ET balloon catheter was used to dilate the ET and inject medicine. Efficacy results were assessed by the injection channel patency (ICP) rate, the injection reached the expected site (IRES) rate, and the improvement in eustachian tube function was evaluated by the seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score. Safety results were assessed in terms of adverse events and device defects.
Results: BET was successfully attempted in 87 patients from April 2022 to August 2022 at two academic medical centers in China (01, 02). The ICP rate was 100%, and the IRES rate was 88.51%. The overall ETDQ-7 score was significantly reduced ( p < 0.001) postsurgically at both centers. There were no major complications or device defects.
Conclusion: The double-lumen ET balloon catheter is technically effective and safe for the treatment of ET dysfunction.
期刊介绍：
Otology & Neurotology publishes original articles relating to both clinical and basic science aspects of otology, neurotology, and cranial base surgery. As the foremost journal in its field, it has become the favored place for publishing the best of new science relating to the human ear and its diseases. The broadly international character of its contributing authors, editorial board, and readership provides the Journal its decidedly global perspective.
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