Fraysse B, Bebear J P, Dubreuil C, Berges C, Dauman R
ENT Department, Hopital Purpan, Toulouse, France.
Acta Otolaryngol Suppl. 1991;490:1-10.
This study was designed to compare the efficacy and safety of betahistine dihydrochloride and flunarizine. All patients included in this multicenter, double-blind, randomized trial showed a specific pattern of vertigo, i.e. recurrent paroxysmal vertigo with or without the cochlear symptoms typical of Meniere's disease. Fifty-five patients were treated for 2 months (28 in the betahistine group and 27 in the flunarizine group). Analysis of intra-group symptom changes demonstrated a greater efficacy for betahistine. Statistically significant decreases in duration and severity of attacks, and in the presence of vegetative symptoms were seen in the betahistine group after the first and second months of treatment, whereas in the flunarizine group this was the case only at the end of the first month of treatment. Furthermore in the betahistine group, statistically significant decreases occurred for the other major criteria, including number of attacks, evidence of vestibular dysfunction, and presence of cochlear symptoms. Adverse effects were similar to those reported in previous studies of both products: stomach pains only with betahistine, and drowsiness, asthenia, and depression with flunarizine.
本研究旨在比较二盐酸倍他司汀和氟桂利嗪的疗效与安全性。纳入这项多中心、双盲、随机试验的所有患者均表现出特定的眩晕模式,即伴有或不伴有梅尼埃病典型耳蜗症状的复发性阵发性眩晕。55例患者接受了2个月的治疗(倍他司汀组28例,氟桂利嗪组27例)。组内症状变化分析显示倍他司汀疗效更佳。在治疗的第1个月和第2个月后,倍他司汀组发作的持续时间和严重程度以及自主神经症状均有统计学意义的显著降低,而氟桂利嗪组仅在治疗第1个月末出现这种情况。此外,在倍他司汀组,其他主要标准也有统计学意义的显著降低,包括发作次数、前庭功能障碍证据和耳蜗症状的存在。不良反应与既往两种产品的研究报道相似:倍他司汀仅出现胃痛,氟桂利嗪出现嗜睡、乏力和抑郁。