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首页> 外文期刊>International Journal of General Medicine >Effects and tolerability of betahistine in patients with vestibular vertigo: results from the Romanian contingent of the OSVaLD study
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Effects and tolerability of betahistine in patients with vestibular vertigo: results from the Romanian contingent of the OSVaLD study

机译：倍他司汀对前庭性眩晕患者的影响和耐受性：罗马尼亚OSVaLD研究小组的结果

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Background and methods: An efficacy population of 245 patients with vertigo of peripheral vestibular origin was recruited in Romania as part of a 3-month multinational, post-marketing surveillance study of open-label betahistine 48 mg/day (OSVaLD). Endpoints were changes in the Dizziness Handicap Index (primary endpoint), Medical Outcome Study Short-Form 36 (SF-36v2?), and the Hospital Anxiety and Depression Scale. Results: During treatment, the total Dizziness Handicap Index score improved by 41 points (on a 100-point scale). Statistically significant improvements of 12–14 points were recorded in all three domains of the Dizziness Handicap Index scale (P<0.0001). Betahistine therapy was also accompanied by progressive improvements in mean Hospital Anxiety and Depression anxiety and depression scores (P<0.0001) and significant improvements in both the physical and mental component summary of the SF-36v2 (P<0.0001). Betahistine was well tolerated, with only one suspected adverse drug reaction recorded in the Romanian safety population (n=259). Conclusion: Betahistine 48 mg/day was associated with improvements in multiple measures of health-related quality of life and had a good tolerability profile in these Romanian patients with recurrent peripheral vestibular vertigo.
机译：背景与方法：作为开放性甜菜碱48 mg /天（OSVaLD）的3个月跨国上市后监测研究的一部分，罗马尼亚招募了245名周围前庭源性眩晕患者。终点包括头晕障碍指数（主要终点），医学成果研究简表36（SF-36v2？）和医院焦虑与抑郁量表的变化。结果：在治疗过程中，头晕障碍指数总得分提高了41分（以100分制）。在头晕障碍指数量表的所有三个域中均记录有12-14点的统计学显着改善（P <0.0001）。 Betahistine治疗还伴随着平均住院焦虑和抑郁焦虑和抑郁评分的逐步改善（P <0.0001）以及SF-36v2的身心组成部分的显着改善（P <0.0001）。 Betahistine的耐受性良好，罗马尼亚安全人群中仅记录了一种可疑的药物不良反应（n = 259）。结论：在这些罗马尼亚复发性前庭周围性眩晕患者中，甜菜碱48 mg /天与多种健康相关生活质量指标的改善有关，并且具有良好的耐受性。

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