Effects of Endolymphatic Sac Drainage With Steroids for Intractable Meniere's Disease: A Long-Term Follow-Up and Randomized Controlled Study
Effects of Endolymphatic Sac Drainage With Steroids for Intractable Meniere's Disease: A Long-Term Follow-Up and Randomized Controlled Study
复制标题
DOI：
10.1097/mlg.0b013e3181651c4a
复制
发表时间：
2008-05-01
期刊：
影响因子：
2.6
通讯作者：
Kitahara, Masaaki
中科院分区：
文献类型：
--
作者：
Kitahara, Tadashi;Kubo, Takeshi;Kitahara, Masaaki
目的：梅尼埃病是一种常见的内耳疾病，发病率为15 ~ 50/10万。由于梅尼埃病被认为是由内耳的免疫损伤引发的，我们研究了内淋巴囊应用类固醇作为顽固性梅尼埃病的新治疗策略。研究设计：前瞻性随机对照研究。方法：在1996年和2005年之间，我们招募了197名顽固性梅尼埃病患者，并将其分为三组进行随机对照试验：组I（G-I）-接受内淋巴囊引流和类固醇滴注的患者;组II（G-II）-接受内淋巴囊引流但未滴注类固醇的患者;组III（G-III）-拒绝内淋巴囊引流的患者。治疗后2 ~ 7年，对3组患者的听力和听力进行测定。根据1995年美国耳鼻咽喉头颈外科学会（AAO-HNS）标准，2年结果表明，眩晕完全控制的患者中，G-I组（n = 100）为88.0%，G-II组（n = 47）为85.1%，G-III期占8.0%（n = 50）。从统计学上讲，G-I = G-II > G-III。G-I组49.0%的患者听力改善，G-II组31.9%的患者听力改善，G-III组6.0%的患者听力改善（G-I > G-II > G-III）。7年后的结果显示，眩晕完全控制率G-I为78.8%，G-II为79.2%，G-III为25.0%（G-I = G-II > G-III）。G-I组36.5%的患者听力改善，G-II组8.3%，G-III组0.0%（G-I > G-II = G-III）.从G-III治疗后至少7年的非手术观察来看，G-I患者的内淋巴囊内滴注类固醇显著改善了难治性梅尼埃病患者的听力，在G-II期患者中，这比不使用类固醇的内淋巴囊引流更明显。
Objective: 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.Study Design: Prospective randomized controlled study.Methods: 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.Results: 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).Conclusions: 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.