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[曲美他嗪与倍他司汀治疗梅尼埃病的双盲法研究]

[Trimetazidine versus betahistine in Ménière's disease. A double blind method].

作者信息

Martini A, De Domenico F

机构信息

ENT Dept., University of Padova, Italie.

出版信息

Ann Otolaryngol Chir Cervicofac. 1990;107 Suppl 1:20-7.

PMID:2240995
Abstract

The efficacy and acceptability of trimetazidine (60 mg daily) in the treatment of Meniere's disease were compared with those of betahistine (36 mg daily) during a double-blind study spanning two months. Enrolled in the study were 45 patients (33 treated with trimetazidine, 23 with betahistine) presenting cochlear symptoms (vertigo, tinnitus, hearing loss) compatible with a diagnosis of Meniere's disease. Five patients dropped out of the study (3 in the trimetazidine group did not comply with the therapy and 2 in the betahistine group complained of poor response to the treatment) and were not taken into account in the final analysis, which therefore bore on 40 patients (19 receiving trimetazidine and 21 receiving betahistine). Trimetazidine was found to be significantly more effective than betahistine as far as the overall evolution of the ENT disease was concerned, yielding 79% and 57% improvement rates in each group, respectively (p = 0.027). Complete disappearance of the dizziness attacks was noted in 10 patients out of 19 in the trimetazidine group, versus 5/21 patients in the betahistine group (p = 0.06). There was no statistically significant difference between both treatments, as assessed from other clinical or audiometric criteria. Clinical acceptability was equally excellent in both treatment groups.

摘要

在一项为期两个月的双盲研究中,比较了曲美他嗪(每日60毫克)和倍他司汀(每日36毫克)治疗梅尼埃病的疗效和可接受性。该研究纳入了45例出现与梅尼埃病诊断相符的耳蜗症状(眩晕、耳鸣、听力损失)的患者(33例接受曲美他嗪治疗,23例接受倍他司汀治疗)。5例患者退出研究(曲美他嗪组3例未遵医嘱治疗,倍他司汀组2例抱怨治疗反应不佳),最终分析未将其纳入,因此最终分析涉及40例患者(19例接受曲美他嗪治疗,21例接受倍他司汀治疗)。就耳鼻喉疾病的总体进展而言,发现曲美他嗪比倍他司汀显著更有效,两组的改善率分别为79%和57%(p = 0.027)。曲美他嗪组19例患者中有10例眩晕发作完全消失,而倍他司汀组为5/21例患者(p = 0.06)。根据其他临床或听力测定标准评估,两种治疗之间无统计学显著差异。两个治疗组的临床可接受性同样良好。

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