三七通舒胶囊治疗常见耳源性眩晕的多中心随机对照临床研究

目的:探讨三七通舒胶囊治疗常见耳源性眩晕疾病的疗效及安全性。方法:采用多中心随机对照试验方法,将206例常见耳源性眩晕(突发性聋伴眩晕、梅尼埃病和良性阵发性位置性眩晕)患者随机分为三七通舒组(155例)和敏使朗组(51例),治疗期为14d。治疗前后使用眩晕障碍量表(DHI)进行生活质量评估。结果:采用全分析集(FAS)分析三七通舒组和敏使朗组有效率,结果分别为84.86%和90.92%(P>0.05);采用符合方案集(PPS)分析的结果分别为84.76%和90.92%(P>0.05)。治疗14d后,FAS和PPS分析表明:2组DHI评分均较治疗前降低,且各分项(包括身体、情绪、功能)的评分也较治疗前降低,差异有统计学意义(P<0.01);2组间治疗前后DHI评分的差值,以及各分项(包括身体、情绪、功能)评分的差值,差异均无统计学意义(均P>0.05)。安全性分析表明:三七通舒组不良反应发生率为3.29%,敏使朗组为7.84%,2组间比较差异无统计学意义(P>0.05)。结论:三七通舒胶囊是一种安全、有效的治疗常见耳源性眩晕疾病的药物。

Clinical effectiveness and safety of sanchi tong shu capsule in the treatment of aural vertigo: a multi-center randomized controlled clinical trial

Objective:To evaluate the clinical effectiveness and safety of Sanchi Tong Shu capsule in the treatment of common aural vertigo.Method:A multi-center randomized controlled trial was designed to study 206 vertigo patients who were randomly allocated into one of the two groups.One group was treated with Sanchi Tong Shu capsule for 14 days,another group was treated with betahistine mesilate tablets for 14 days.Result:The clinical effectiveness rates of the two groups were 84.86% and 90.92% respectively according to FAS analysis and 84.76%,90.92% respectively according to PPS analysis.No statistic significance difference was found between the two groups(P>0.05).After 14 days treatment,total DHI and all the subsection(including body,emotion and fuction) scores of the two groups were all decreased compared with treatment before(P<0.01).Compared the difference value of the total DHI and subsection scores before and after treatment,the two groups have no difference(P>0.05).The adverse effective rate of the two groups were 3.29% and 7.84% respectively and there was no statistic difference between the two groups(P>0.05).Conclusion:Sanchi Tong Shu capsule is a safe and effective drug for the treatment of common aural vertigo.