天麻醒脑胶囊治疗轻中度血管性痴呆(肝肾不足、肝风上扰证)的随机、双盲、平行对照、多中心临床研究

目的评价天麻醒脑胶囊治疗轻中度血管性痴呆(肝肾不足、肝风上扰证)的临床疗效及安全性。方法采用随机、双盲、平行对照、多中心临床试验的临床研究方法,将12个分中心的180例血管性痴呆患者,按照3∶1的比例随机分为试验组135例(天麻醒脑胶囊治疗)和对照组45例(复方苁蓉益智胶囊治疗),两组疗程均为24周。比较两组患者治疗前后的阿尔茨海默病评定量表-认知部分(Alzheimer's disease assessment scale-cognitive section,ADAS-cog)量表、血管性痴呆辨证量表(scale for the differentiation of syndromes of vascular dementia,SDSVD)、简易精神状态检查(mini mental status examination,MMSE)量表、日常生活活动能力(activity of daily living,ADL)量表评分及安全性。结果最终有165例(试验组123例、对照组42例)患者完成试验。共有7例受试者脱落,试验组5例,对照组2例;违背试验方案共8例,其中试验组7例,对照组1例。与治疗前比较,治疗36周后两组ADAS-cog评分差异均有统计学意义(P<0.05)。与治疗前比较,治疗24周后两组患者SDSVD评分均显著减少(P<0.05),且试验组减少程度大于对照组(P<0.05)。与治疗前比较,治疗24、36周后两组患者MMSE评分、ADL评分均显著增加(P<0.05);治疗36周后两组患者MMSE、ADL评分比较,差异有统计学意义(P<0.05)。未观察到天麻醒脑胶囊引起的不良反应。结论天麻醒脑胶囊治疗轻中度血管性痴呆(肝肾不足、肝风上扰证)24周可以改善患者的认知功能和生活质量,且这种益处至少持续12周,疗效确切,安全性好。

Clinical Effect of Tianma Xingnao Capsule in Treatment of Mild or Moderate Vascular Dementia with Deficiency of Liver and Kidney and Liver Disturbance: A Randomized, Double-blind, Parallel-controlled, and Multicenter Clinical Study

Objective To investigate the clinical effect and safety of Tianma Xingnao Capsule in the treatment of mild or moderate vascular dementia with deficiency of liver and kidney and liver disturbance.Methods In this randomized,double-blind,parallel-controlled,and multicenter clinical trial,180 patients with vascular dementia from 12 centers were randomly divided into trial group(135 patients treated with Tianma Xingnao Capsule)and control group(45 patients treated with Compound Congrong Yizhi Capsule)at a ratio of 3∶1,and the course of treatment was 24 weeks for both groups.The two groups were compared in terms of Alzheimer's Disease Assessment Scale-cognitive subscale(ADAS-cog)score,Scale for the Differentiation of Syndromes of Vascular Dementia(SDSVD)score,Mini-Mental State Examination(MMSE)score,Activities of Daily Living(ADL)score,and safety.Results A total of 165 patients(123 patients in the trial group and 42 in the control group)completed the trial.Seven patients were lost to follow-up,with 5 in the trial group and 2 in the control group;protocol violation was observed in 8 patients,with 7 in the trial group and 1 in the control group.Both groups had a significant change in ADAS-cog score after 36 weeks of treatment(P<0.05).After 24 weeks of treatment,both groups had a significant reduction in SDSVD score(P<0.05),and the trial group had a significantly greater reduction than the control group(P<0.05).After 36 weeks of treatment,both groups had significant increases in MMSE and ADL scores(P<0.05),and after 36 weeks of treatment,there were significant differences in MMSE and ADL scores between the two groups(P<0.05).No adverse events caused by Tianma Xingnao Capsule were observed.Conclusion Tianma Xingnao Capsule treatment for 24 weeks can improve patients'cognitive function and quality of life,which can last for at least 12 weeks,with a marked clinical effect and good safety.