养血清脑颗粒治疗轻中度血管性认知障碍患者多中心研究

Mulficenter study on the treatment of cerebralcare granule for patients with mild and moderate vas- cular cognitive impairmen

目的探讨合用养血清脑颗粒与单纯基础治疗轻中度血管性认知障碍（vascular cognitive impairment，VCI）患者认知功能障碍的改善情况。方法选取2014年10月至2017年12月期间在河北省内多地区10家三甲及二甲医院收治的164例VCI患者作为研究对象，将VCI患者分为两组：试验组（养血清脑颗粒组，n=98）和对照组（常规治疗组，n=66），比较两组患者治疗前、治疗后3个月及6个月简明精神状态检查（MMSE）、蒙特利尔认知评估量表（MoCA）及日常生活能力量表（ADL）的得分变化。结果①治疗后6个月试验组MMSE总分高于对照组，差异有统计学意义[（23．76±4．02）分，（21．52±5．13）分，P〈0．05]；②治疗后6个月试验组MoCA总分[（21．06±4．66）分，（18．32±5．20）分]及其视空间／执行功能[（3．05±1．37）分，（2．42±1．66）分]、计算力[（2．24±0．84）分，（1．83±1．05）分]和定向力[（5．20±1．12）分，（4．06±1．35）分]均高于对照组，差异有统计学意义（P〈0．05）；③治疗后6个月试验组ADL得分低于治疗前，差异有统计学意义[（24．96±8．74）分，（29．20±11．55）分，P〈0．05]，但与对照组治疗比较，差异无统计学意义（P〉0．05）。结论养血清脑颗粒治疗可以改善轻中度VCI患者的认知功能，主要体现在视空间／执行功能、计算力及定向力方面，且随着治疗时间的延长，疗效越明显。

Objective To explore the improvement of cognitive impairment in patients with mild and moderate vascular cognitive impairment（VCI） treated with cerebralcare granule （CG） and basic treat- ment.Methods From October in 2014 to December in 2016 year, 143 cases of VCI patients were admitted from six hospitals in some areas of Hebei Province as the research objects, and divided into CG treatment group （experimental group ,n=98） and conventional treatment group （control group, n=66 ）.Three months and six months after treatment, the score of mental state examination （MMSE）, the Montreal cognitive assess- ment scale （MoCA） and the daily living capacity scale（ADL） of the two groups were compared after 3 and 6 moths of treatment.Results ①The total score of MMSE in the experimental group was higher than that of the control group for six months after treatment, and the difference was statistically significant （ （ 23.76 ± 4.02） vs （21.52±5.13） ,P〈0.05）.② Six months after treatment,the total score of MoCA （（21.06±4.66） vs （ 18.32± 5.20 ） ） and visual spatial/executive function （ （ 3.05 ± 1.37 ） vs （ 2.42± 1.66 ） ） , calculation force （（2.24±0.84） vs （1.83±1.05） ） and orientation ability（（5.20±1.12） vs （4.06±1.35）） scores in the ex- perimental group were significantly higher than those in the control group （P〈0.05）.③Six months after treat- ment, the ADL score in the experimental group was lower than that before treatment, and the difference was statistically significant（（24.96±8.74） vs （29.20± 11.55） ,P〈0.05） ;while there was no significant difference in the ADL score between the experimental group and the control group after 6 months （P〉0.05）.Conclusion CG can improve cognitive function in mild to moderate VCI patients, mainly in visual space/execution func- tion, calculation ability and orientation ability, and with the extension of treatment time, the curative effect is more obvious.