软脉灵口服液治疗血管性痴呆的临床研究

目的观察软脉灵口服液治疗血管性痴呆（VaD）的临床疗效及安全性，并探讨其作用机制。方法将60例VaD患者按1：1比例随机分为两组。治疗组（30例）予软脉灵口服液，每次1支（10mL），每日3次口服，1个月为1个疗程，连服3个疗程；对照组（30例）予以盐酸多奈哌齐（思博海），每次1片（5mg），每日1次临睡前口服，疗程同治疗组。结果总有效率治疗组（96．7％）与对照组（86．7％，）无统计学意义（P〉0．05）；在简易智能量表（minimentalstateexamination，MMSE）、日常生活功能水平量表（activities of daily living，ADL）积分和实验室指标同型半胱氨酸（Hey）、血栓素A2（TXA2）、前列环素I2（PGI2）等方面两组比较无统计学意义（P〉0．05）；在中医证候疗效、临床症状改善、实验室指标内皮素（ET）、TXA2／PGI2等方面，治疗组明显优于对照组（P〈0．05）。结论软脉灵口服液为治疗血管性痴呆的有效药物。

Clinical Study on Ruanmailing Oral Liquid in treatment of Vascular Dementia

Objective To observe the clinical curative effect and safety of Ruanmailing oral liquid for vascular dementia （VaD）. Methods Sixty patients with VaD were randomized into two groups：Treatment group （n：= 30） treated with Ruanmailing oral liquid and control group （n= 30） treated with donepezil for 3 months. Results The total effective rate in two groups were 96.7% and 86. 7% respectively（P〉0.05）, There were no significant difference in the mini - mental state examination （MMSE）, the activity of daily living （ADL） and the levels of homocysteine（Hcy）, thromboxane A2 （TXA2）, prostaglandin I2 （PGI2） in two groups（P〉0.05）. The efficacy of the TCM symptom,improvement of clinical symptoms and endothelins （ET）,TXA2/PGI2 in treatment group were better than that control group（P〈0.05）. Conclusion Ruanmailing oral liquid had good effect in treatment of vascular dementia.