阿米三嗪-萝巴新治疗耳蜗前庭疾患的疗效及安全性  

Efficacy and tolerability of almitrine bismesylate in treating patients with vestibular disturbances: a multicenter study

作　　者：苗玲[1] 张瑛[1] 郭明光[1] 赵文为[1] 徐群[1] 耿介立[1] 李红伟[1] 

机构地区：[1]上海第二医科大学附属仁济医院神经内科,200001

出　　处：《中华神经科杂志》2004年第5期424-427,共4页Chinese Journal of Neurology

摘　　要：目的　评价阿米三嗪 萝巴新治疗耳蜗前庭疾患的疗效及安全性。方法　多中心开放自身对照研究。 2 3个中心 6 6 2例门诊眩晕患者入选 ,伴或不伴耳鸣。所有患者均应用阿米三嗪 萝巴新 1片 ,每日 2次 ,连续使用 3个月 ,评估治疗前、治疗 1个月、治疗 3个月眩晕、眼震、耳鸣情况变化 ,伴听力下降者随访电测听结果。研究结束时由患者和医师分别评价总体疗效 ,记录所有不良反应。结果　治疗前、治疗 1个月、治疗 3个月眩晕、眼震、耳鸣 0～ 3级病例数经F检验差异有非常显著意义 (眩晕严重程度F =2 2 0 1 6 4 ,眩晕持续时间F =10 31 4 7,眩晕发作频率F =10 35 38,眼震F =132 4 14 ,耳鸣F =80 7 0 4 ,均P <0 0 1)。 10 4例电测听异常患者在治疗 1个月、治疗 3个月分别有2 0 2 %、30 8%转为正常 (F =30 4 7,P <0 0 1)。阿米三嗪 萝巴新能明显改善患者的眩晕、眼震、耳鸣及电测听检查结果。治疗前后、治疗 1个月与 3个月之间差异有非常显著意义 (P <0 0 1)。研究者及患者总体疗效评价好。不良反应发生率治疗 1个月时为 1 98% ,3个月时为 1 11%。结论　阿米三嗪 萝巴新是一个治疗耳蜗前庭疾患的有效、安全药物。Objective To evaluate the therapeutic effects of almitrine bismesylate in patients with vestibular syndrome. Methods A multicenter self-controlled trial was carried out in which 662 outpatients with vestibular disturbances were treated using almitrine bismesylate in a dose of 2 tablets per day for three months. The frequency, duration, and intensity of vertigo, nystagmus, tinnitus and electrohearing test results were evaluated at a baseline, one-month and three-month following-up.Results Compared with data among baseline,one-month and three-month after therapy, the numbers of patients with vertigo, nystagmus, tinnitus in 0-3 degrees were significantly different. The F value of intensity of vertigo was 2201.64, duration of vertigo was 1031.47, intensity of vertigo was 1035.38, nystagmus was 1324.14, and tinnitus was 807.04. All differences in above groups reached a significant level (P<0.01). 20.2% of the 104 patients with an abnormal electrohearing test were turned out to be normal after one-month therapy and 30.8% after three-month's (F=30.47, P<0.01). The results indicated vertigo, nystagmus, tinnitus and electrohearing test were improved significantly by almitrine bismesylate. The incidence of adverse reaction was 1.98% at one-month therapy and 1.11% at three-month therapy. Clinical and biological acceptability was good.Conclusions Almitrine bismesylate is beneficial and safe in treating patients with vestibular disturbances.

关 键 词：治疗 眩晕 阿米三嗪 患者 耳鸣 前庭 耳蜗 记录 变化 

分 类 号：R764[医药卫生—耳鼻咽喉科] R735.7[医药卫生—临床医学]