Kitahara Tadashi, Kubo Takeshi, Okumura Shin-ichi, Kitahara Masaaki
Department of Otolaryngology, Osaka University, School of Medicine, Osaka, Japan.
Laryngoscope. 2008 May;118(5):854-61. doi: 10.1097/MLG.0b013e3181651c4a.
Meniere's disease is a common inner ear disease with an incidence of 15 to 50 per 100,000 population. Since Meniere's disease is thought to be triggered by an immune insult to the inner ear, we examined intraendolymphatic sac application of steroids as a new therapeutic strategy for intractable Meniere's disease.
Prospective randomized controlled study.
Between 1996 and 2005, we enrolled and assigned 197 intractable Meniere's patients to three groups in a randomized controlled trial: Group I (G-I)- patients who underwent endolymphatic sac drainage and steroid-instillation; Group II (G-II)-those who underwent endolymphatic sac drainage without steroid-instillation; and Group III (G-III)-those who declined endolymphatic sac drainage. Definitive spells and hearing in all three groups were determined for 2 to 7 years after treatment.
According to the 1995 American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) criteria, 2-year results demonstrated that vertigo was completely controlled in 88.0% of patients in G-I (n = 100), 85.1% of patients in G-II (n = 47), and 8.0% in G-III (n = 50). Statistically, G-I = G-II>G-III. Hearing was improved in 49.0% of patients in G-I, 31.9% in G-II, and 6.0% in G-III (G-I>G-II>G-III). Results after 7 years showed that vertigo was completely controlled in 78.8% of patients in G-I, 79.2% in G-II, and 25.0% in G-III (G-I = G-II>G-III). Hearing improved in 36.5% of patients in G-I, 8.3% in G-II, and 0.0% in G-III (G-I>G-II = G-III).
From non-surgical observation in G-III for at least 7 years after treatment, steroids instilled into endolymphatic sac in G-I patients significantly improved hearing in intractable Meniere's patients, more so than endolymphatic sac drainage without steroids in G-II patients.
梅尼埃病是一种常见的内耳疾病，发病率为每10万人中有15至50例。由于梅尼埃病被认为是由内耳的免疫损伤引发的，我们研究了在内淋巴囊内应用类固醇作为治疗难治性梅尼埃病的一种新的治疗策略。
前瞻性随机对照研究。
在1996年至2005年期间，我们将197例难治性梅尼埃病患者纳入一项随机对照试验，并将其分为三组：第一组（G-I）——接受内淋巴囊引流和类固醇灌注的患者；第二组（G-II）——接受内淋巴囊引流但未进行类固醇灌注的患者；第三组（G-III）——拒绝内淋巴囊引流的患者。在治疗后2至7年确定所有三组患者的明确发作情况和听力。
根据1995年美国耳鼻咽喉头颈外科学会（AAO-HNS）标准，2年的结果表明，G-I组（n = 100）中88.0%的患者眩晕得到完全控制，G-II组（n = 47）中85.1%的患者眩晕得到完全控制，G-III组（n = 50）中8.0%的患者眩晕得到完全控制。统计学上，G-I = G-II>G-III。G-I组中49.0%的患者听力得到改善，G-II组中31.9%的患者听力得到改善，G-III组中6.0%的患者听力得到改善（G-I>G-II>G-III）。7年后的结果表明，G-I组中78.8%的患者眩晕得到完全控制，G-II组中79.2%的患者眩晕得到完全控制，G-III组中25.0%的患者眩晕得到完全控制（G-I = G-II>G-III）。G-I组中36.5%的患者听力得到改善，G-II组中8.3%的患者听力得到改善，G-III组中0.0%的患者听力得到改善（G-I>G-II = G-III）。
通过对G-III组治疗后至少7年的非手术观察，G-I组患者向内淋巴囊内灌注类固醇显著改善了难治性梅尼埃病患者的听力，比G-II组未使用类固醇的内淋巴囊引流效果更好。
