健脑益智颗粒治疗血管性痴呆的随机双盲临床研究

Clinical Randomized Double-Blinded Study on Treatment of Vascular Dementia by Jiannao Yizhi Granule

目的 :开展中医药治疗血管性痴呆 (vasculardementia,VD)的疗效观察及评定方法的研究。方法 :采用多中心、随机双盲对照的研究方法 ,选取符合VD纳入标准的轻中度患者 2 4 2例 ,其中中药治疗组89例 (口服健脑益智颗粒 ) ,西药对照组 10 6例 (口服喜得镇 ) ,安慰剂组 4 7例 ,治疗 6 0天后 ,采用简易智力状态检查表 (MMSE)、Blessed行为量表 (BBS)和中医症状分级评分的方法进行疗效评估。结果 :中药治疗组总有效率为 5 8 4 % ,较安慰剂组及西药对照组治疗效果为优。该药在整体调节、改善全身机能状况方面优势明显 ,不仅对轻中度VD智能障碍的核心症状及智能障碍所致的功能活动下降具有改善作用 ,而且还具有明显减轻或消除周边症状的作用。结论 :健脑益智颗粒治疗VD疗效确切 ,值得推广。

Objective: To observe the effect of Chinese herbal medicine in treating vascular dementia (VD) and to explore the method for therapeutic effect evaluation. Methods: Multi center, double blinded randomize controlled method was adopted to observe the effect of treatment of 242 patients with VD of mild or middle degree, they were 89 cases in the TCM group, 106 cases in the western medicine group and 47 in the placebo group. Mini mental state examination (MMSE), Blessed dementia scoring and scoring on TCM symptom classified evaluation were used to evaluate the therapeutic effect after 60 days treatment. Results: The total effective rate of Jiannao Yizhi Granule was 58.4%, showing a better effect than that of the placebo group and the western medicine group respectively. The treatment was superior in holistic regulation and systemic functional state improvement, it could not only improve the mild middle key symptoms of VD and the mental disorder induced reduction of functional activities, but also alleviate or eliminate the peripheral symptoms of VD. Conclusion: The effect of treatment of vascular dementia by Jiannao Yizhi Granule is certain and is worth spreading.