Department of Ear, Nose, and Throat, State Budgetary Educational Institution of Higher Professional Training, IM Sechenov First Moscow State Medical University of the Ministry of Healthcare and Social Development of the Russian Federation, Moscow, Russian Federation.
Federal State Budgetary Institution, Scientific Neurology Center of the Russian Academy of Medical Sciences, Moscow, Russian Federation.
Int J Gen Med. 2015 Jan 22;8:47-53. doi: 10.2147/IJGM.S73842. eCollection 2015.
We report here data from the >200 patients recruited in Russia to take part in OSVaLD, a 12-week, open-label, post-marketing surveillance study of the response to betahistine 48 mg/day in vertigo of peripheral vestibular origin carried out in a total of 13 countries.
The primary efficacy endpoint was change in the Dizziness Handicap Inventory (DHI; 100-point scale). Changes in Hospital Anxiety and Depression Scale (HADS) and Medical Outcomes Study Short-Form 36, version 2 (SF-36v2(®)) scores were a priori secondary Outcomes.
Total DHI score improved by 43 points during betahistine treatment. This aggregate improvement was equally distributed across the three domains of the DHI (physical, emotional, and functional; P<0.0001 for main and subscore changes from baseline). Statistically significant improvements versus baseline were also observed in mean HADS scores for anxiety and depression (both P<0.0001), and in the Physical Component Summary and Mental Component Summary scores of the SF-36v2 (both P<0.0001 versus baseline). Only one suspected adverse drug reaction was recorded in the Russian safety population (n=204), indicating that betahistine was well tolerated in those patients.
Betahistine 48 mg/day was associated with clear improvements in well-configured and widely validated measures of health-related quality of life and an encouraging tolerability profile in patients in Russia who took part in OSVaLD.
我们在此报告了在俄罗斯招募的 >200 名患者的数据，这些患者参加了 OSVaLD，这是一项为期 12 周、开放性、上市后监测研究，旨在评估倍他司汀 48mg/天治疗外周性前庭源性眩晕的反应，该研究在总共 13 个国家进行。
主要疗效终点是眩晕残障程度量表（DHI；100 分制）的变化。医院焦虑抑郁量表（HADS）和医疗结局研究 36 项简短量表，第二版（SF-36v2(®)）评分的变化是预先设定的次要终点。
倍他司汀治疗期间，总 DHI 评分改善了 43 分。这种综合改善在 DHI 的三个领域（身体、情感和功能）中均匀分布（主要和子评分从基线的变化均 P<0.0001）。与基线相比，焦虑和抑郁的 HADS 评分均值也有显著改善（均 P<0.0001），SF-36v2 的生理成分综合评分和心理成分综合评分也有显著改善（均 P<0.0001 与基线相比）。在俄罗斯安全性人群（n=204）中仅记录到 1 例疑似药物不良反应，表明倍他司汀在这些患者中具有良好的耐受性。
在俄罗斯参加 OSVaLD 的患者中，倍他司汀 48mg/天与广泛验证的健康相关生活质量指标的明显改善以及令人鼓舞的耐受性相关。
