Coyas A
General Hospital of Athens, Papagos, Gréce.
Ann Otolaryngol Chir Cervicofac. 1990;107 Suppl 1:82-7.
In order to assess the efficacy of trimetazidine in the treatment of ischemia-related cochleovestibular disorders, we carried out a double-blind placebo-controlled study with crossover. Each treatment period spanned 2 months, during which the patients were given either trimetazidine (20 mg tid) or placebo, following a two-week washout period. Enrolled in the study were 45 patients (aged 32 to 69 years) presenting cochleovestibular symptoms (tinnitus, vertigo, hearing loss). Tinnitus occurred in 99.7% of cases, deafness in 88.8%, and vertigo in 68.8% of cases. Pure-tone and speech audiometric data were not modified. Improvement was felt primarily with respect to subjective symptoms. The intensity of vertigo events and the duration of the spells improved much more substantially by trimetazidine and placebo, although the limited number of patients studied did not allow to reach the threshold of significance. The activity of trimetazidine was particularly apparent in relation to tinnitus. The intensity of the latter symptom as well as the degree of discomfort occasioned by it diminished more significantly with trimetazidine than placebo following a 2-month treatment period (p less than 0.05 and p less than 0.02, respectively). These results underscore the therapeutical efficacy of trimetazidine in the treatment of cochleovestibular syndromes, as assessed by a rigorously controlled double-blind trial with crossover versus placebo using a reliable methodology.
为了评估曲美他嗪治疗缺血性耳蜗前庭疾病的疗效,我们进行了一项双盲安慰剂对照交叉研究。每个治疗期为2个月,在此期间,患者在经过两周的洗脱期后,接受曲美他嗪(20毫克,每日三次)或安慰剂治疗。纳入该研究的有45例出现耳蜗前庭症状(耳鸣、眩晕、听力损失)的患者(年龄在32至69岁之间)。99.7%的病例出现耳鸣,88.8%出现耳聋,68.8%出现眩晕。纯音和言语听力测定数据未发生改变。主要在主观症状方面有改善。曲美他嗪和安慰剂在眩晕发作强度和发作持续时间方面的改善更为显著,尽管研究的患者数量有限,未达到显著性阈值。曲美他嗪的作用在耳鸣方面尤为明显。在为期2个月的治疗期后,与安慰剂相比,曲美他嗪使耳鸣症状的强度及其引起的不适程度减轻得更显著(分别为p<0.05和p<0.02)。这些结果强调了曲美他嗪在治疗耳蜗前庭综合征方面的治疗效果,这是通过一项严格对照的双盲交叉试验与安慰剂对比,并采用可靠方法评估得出的。