| Objective:To explore the clinical effect of Shenma Yizhi decoction combined with Ginkgo biloba tablet on patients with vascular dementia,to evaluate its effect on cognitive function and vascular endothelial function,and to explore the possible mechanism of its treatment of vascular dementia.Methods:Based on the principles of randomized,controlled and double-blind trials,196 patients who met the diagnostic criteria for vascular dementia and traditional Chinese medicine(TCM)syndrome diagnosis criteria for qi-deficiency and blood-stasis Yang hyperactivity from June 2018 to October 2018 in Jingzhuang town and Shenjiayin town,Yanqing district,Beijing were randomly divided into the treated group(98 cases)and the control group(98 cases).The treated group was given Shenma Yizhi granule+ginkgo biloba orally,and the control group was given Shenma Yizhi granule simulant+ginkgo biloba orally.In both groups,six weeks were taken as one course of treatment,and a total of 2 courses of treatment were observed.All patients received MMSE,ADAS-Cog,ADL and TCM symptom scale scores before and after treatment,and serum ET-1,NO,VEGF and vWF levels were detected before and after treatment.Safety indicators including liver function,renal function,blood routine,urine routine and electrocardiogram were recorded before and after treatment,as well as adverse events during the experiment.Results:1 Both two groups could significantly improve the MMSE scores of VD patients,and the improvement was more obvious in the treated group,which was statistically significant compared with the control group(P<0.05).MMSE was used to evaluate the clinical efficacy,the total effective rate of the treated group was 49.4%,and the total effective rate of the control group was 34.5%.The difference in clinical efficacy between the two groups after treatment was statistically significant(P<0.05).After treatment,MMSE scores of each item were compared.The scores of "retelling","understanding","reading","writing"and "delayed recall" in the treated group were significa ntly higher than those in the control group,and the differences were statistically significant(P<0.05).2.Both two groups could significantly reduce the score of ADAS-Cog in patients with VD,and the score in the treated group was significantly lower than that in the control group(P<0.05).The clinical efficacy was evaluated by ADAS-Cog,and the total effective rate was 69.4%in the treated group and 54.0%in the control group.The difference in clinical efficacy between the two groups after treatment was statistically significant(P<0.05).After treatment,ADAS-Cog scores of each item were compared.The scores of "word recall","instruction","word recognition" and "language comprehension ability",in the treated group were significantly improved compared with those in the control group(P<0.05).3.ADL scores of the two groups were lower after treatment than before treatment,and the difference was statistically significant(P<0.01).There was no significant difference in total ADL scores between the two groups after treatment(P>0.05).ADL was used to evaluate the clinical efficacy.The total effective rate was 24.7%in the treated group and 28.7%in the control group after treatment,and the difference in clinical efficacy between the two groups after treatment was not statistically significant(P>0.05).4.After treatment,the total score of TCM syndromes in the two groups was lower than that before treatment,and the decrease was more obvious in the treated group,and the difference between the two groups was statistically significant(P<0.05).The clinical efficacy was evaluated by the total score of TCM syndromes.The total effective rate was 67.1%in the treated group after treatment and 46.0%in the control group after treatment.The difference in clinical efficacy between the two groups after treatment was statistically significant(P<0.05).Compared with the control group,the single score of TCM syndromes after treatment showed that the treated group showed more improvement in "decreased intelligence","restlessness","mootiness" and "cyanosis of lips" than the control group,and the differences were statistically significant(P<0.05).5.After treatment,the level of ET-1 in both groups was significantly reduced,with statistically significant difference from that before treatment(P<0.01),among which the decrease was more significant in the treated group and statistically significant compared with the control group(P<0.05).NO levels were significantly increased in both groups after treatment,and the difference between the treated group and the pre-treatment group was statistically significant(P<0.05),and the difference between the two groups was statistically significant(P<0.05).After treatment,VEGF levels of the two groups were significantly increased,and the difference was statistically significant(P<0.01),while the difference between the two groups after treatment was not statistically significant(P>0.05).After treatment,vWF levels of patients in both groups were significantly decreased,among which the treated group was significantly lower than that before treatment,with statistically significant differences(P<0.05),while there was no statistically significant difference in vWF levels between the two groups after treatment(P>0.05).Conclusion:1.Shenma Yizhi decoction combined with Ginkgo biloba tablet can significantly improve the cognitive function of patients with VD,and improve the symptoms of VD patients such as mental retardation,restlessness,mootiness and cyanosis.2.Shenma Yizhi decoction combined with Ginkgo biloba tablet to improve the cognitive function of VD patients may be related to its ability to up-regulate the levels of NO and VEGF and down-regulate the levels of ET-1 and vWF,thus improving the vascular endothelial function. |