目的：观察补肾活血开窍方治疗糖尿病所致血管性轻度认知功能障碍的临床疗效。方法：将30 例糖尿病所致血管性轻度认知功能障碍的患者随机分为治疗组（15 例）和对照组（15 例），治疗组予以补肾活血开窍方（肉苁蓉10 g、石菖蒲5 g、三七2.5 g）免煎制剂治疗，每天3 次，同时服用尼莫地平每次30 mg、一日3 次，对照组服用尼莫地平每次30 mg、一日3 次，上述治疗持续6 个月。治疗前后采用临床痴呆评定量表（CDR）、日常生活能力量表（ADL）、蒙特利尔认知评估北京版（MoCA）及中医症候评分进行评估。结果：治疗后2 组均有进步率，治疗组86.70%，对照组33.33%，治疗组总有效率优于对照组（P<0.05）。2 组患者中MoCa 量表和ADL 量表及中医症候评分与同组治疗前比较，差异均有统计学意义（P<0.05），治疗组治疗后优于对照组，2 组比较差异有统计学意义（P<0.05）。2 组不良事件发生率比较经字2 检验无统计学意义。结论：补肾活血开窍方治疗糖尿病所致血管性轻度认知功能障碍临床疗效优于尼莫地平，在改善日常生活能力、认知功能、痴呆程度及中医症候评分方面均优于尼莫地平；不良事件发生率与尼莫地平相当。

This study was aimed to observe clinical efficacy of Bushen Huoxue Kaiqiao (BSHXKQ) treatment of diabetes-induced vascular mild cognitive impairment. A total of 30 cases of diabetes-induced vascular mild cognitive impairment were randomly divided into the treatment group (15 cases) and the control group (15 cases). The treatment group received free-fried BSHXKQ prescription (Cistanche 10 g, Shichangpu 5 g, Sanqi 2.5 g) for treatment 3 times a day, and in combination of 30 mg of nimodipine, 3 times a day. In the control group, 30 mg of nimodipine was orally administrated 3 times a day. The treatment was continued for 6 months. Clinical Dementia Rating (CDR), Activity of Daily Living Scale (ADL), Montreal Cognitive Assessment Beijing Edition (MoCA) and TCM Syndrome Score were used in the evaluation before and after the treatment.The results showed that the rate of progress was in both groups after treatment. In the treatment group, the rate was 86.70%, and in the control group the rate was 33.33% . The total effective rate in the treatment group was superior to the control group (P < 0.05). There were statistical significances in the MoCa Scale,ADL Scale and TCM Syndrome Score before and after treatment in each group (P < 0.05). The treatment effect in the treatment group was superior to the control group (P < 0.05). There was no statistical significancein the incidence of adverse events in both groups. It was concluded that the effect of BSHXKQ prescription in the treatment of diabetes-induced vascular mild cognitive impairment was superior to nimodipine in improving activities of daily living, cognitive function, degree of dementia and TCM syndrome score. There was no difference in the incidence of adverse events compared with nimodipine.

四川省人力资源和社会保障厅川财社[2011]183 号糖尿病及并发症研究（CSZYJ2011016）：补肾活血开窍方对糖尿病所致血管性轻度认知功能障碍二级预防临床疗效研究，负责人：杨东东。