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Войти в исследования The Laryngoscope · 2019
Efficacy of a silicone plug for patulous eustachian tube: A prospective, multicenter case series.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Ikeda Ryoukichi, Oshima Takeshi, Mizuta Kunihiro, Arai Maki, Endo Shiori, Hirai Ryoji, Ikeda Koji, Kadota Satoki, Otsuka Yuki, Yamaguchi Takuhiro, Kawase Tetsuaki, Kobayashi Toshimitsu
Аннотация
OBJECTIVES/HYPOTHESIS: To report the efficacy and safety of transtympanic plugging of the eustachian tube (ET) using a silicone plug (Kobayashi plug) for chronic patulous ET (PET).
STUDY DESIGN: Prospective and multicenter trial conducted in which 30 PET patients were resistant to at least 6 months of conservative treatment.
METHODS: The efficacy and safety of 28 and 27 patients, respectively, were analyzed. All patients fulfilled inclusion and exclusion criteria. The primary end point used the patulous eustachian tube handicap inventory-10 (PHI-10), and the secondary end point used ET function tests such as sonotubometry, tubo-tympano-aerodynamic-graphy, and respiratory movement of the tympanic membrane and auscultation of voice sounds transmitted from the nose through the ET to the external auditory canal at 3months after surgery.
RESULTS: PHI-10 scores were 34.4 ± 4.2, 6.4 ± 9, and 5.7 ± 8.6 at screening, and 3 and 6 months after surgery. Twenty-three cases (82.1%, 95% confidence interval: 63.1%-93.9%) were judged as successes. There were five cases (17.2%) of middle ear effusion, four cases (13.8%) of tympanic membrane perforation, and one case of tinnitus due to surgery to remove the plug. No severe or life-threatening complications were found.
CONCLUSIONS: This study revealed the efficacy and safety of silicone plug insertion for severe PET patients.
LEVEL OF EVIDENCE: 2 Laryngoscope, 130:1304-1309, 2020.
STUDY DESIGN: Prospective and multicenter trial conducted in which 30 PET patients were resistant to at least 6 months of conservative treatment.
METHODS: The efficacy and safety of 28 and 27 patients, respectively, were analyzed. All patients fulfilled inclusion and exclusion criteria. The primary end point used the patulous eustachian tube handicap inventory-10 (PHI-10), and the secondary end point used ET function tests such as sonotubometry, tubo-tympano-aerodynamic-graphy, and respiratory movement of the tympanic membrane and auscultation of voice sounds transmitted from the nose through the ET to the external auditory canal at 3months after surgery.
RESULTS: PHI-10 scores were 34.4 ± 4.2, 6.4 ± 9, and 5.7 ± 8.6 at screening, and 3 and 6 months after surgery. Twenty-three cases (82.1%, 95% confidence interval: 63.1%-93.9%) were judged as successes. There were five cases (17.2%) of middle ear effusion, four cases (13.8%) of tympanic membrane perforation, and one case of tinnitus due to surgery to remove the plug. No severe or life-threatening complications were found.
CONCLUSIONS: This study revealed the efficacy and safety of silicone plug insertion for severe PET patients.
LEVEL OF EVIDENCE: 2 Laryngoscope, 130:1304-1309, 2020.