| Vascular Dementia(VD)refers to the ischemic brain tissue hypoxia caused bycerebrovascular disease and hemorrhagic brain damage caused by the predominantly cognitive function impairment,accompanied by nerve function defect acquired clinical syndrome.High morbidity and the nerve function defect cause its high disability rate and the medical people’s attention gradually.The pathogenesis of vascular dementia is complex,and there is no satisfactory treatment drug at present.Scholars of traditional Chinese medicine(TCM)are trying to actively explore more effective prevention and treatment methods based on the characteristics of multi-target.multi-channel and less adverse reactions of TCM.Objectives:On the one hand,the clinical efficacy and safety of shenma yizhi recipe combined with ginkgo biloba in the treatment of neurological defects in patients with mild and moderate vascular dementia(qi-deficiency and blood-stasis hyperactivity syndrome)were objectively evaluated.On the other hand,to explore the possible mechanism of shenma yizhi recipe combined with ginkgo biloba in the treatment of vascular dementia.Research methods:In this study,the clinical trial method includes a randomized controlled,double-blind and single-simulated which was used to select 196 patients with mild to moderate VD who met the exclusion criteria in jingzhuang town and shenjiaying town,yanqing district,Beijing,and divided into experimental group and control group.98 patients in each group.The experimental group was given a combination of shenma yizhi recipe(1 bag/time,2 times a day.and infusion)and ginkgo biloba leaf(1 tablet/time.3 times a day).while the control group was given ginkgo biloba leaf and shenma yizhi fang granule simulation agent for 3 months.Minimum Mental State Examination(MMSE).Activity of Daily Living Scale(ADL).Neuropsychiatric Inventory were detected before and after the test.NPI.NIH Stroke Scale(NIHSS),TCM syndrome Scale,neuron specific enolase(NSE).brain-derived neurotrophic factor(BDNF),Homocysteine(Hcy).At the same time,blood,urine routine,liver and kidney function,electrocardiogram and other safety indexes of the enrolled patients were detected.Results:1.Comparison of balance before treatment:Before treatment,there were no statistical differences in brain CT.previous medical history,Body Mass Index(BMI)and demographic characteristics between the two groups,which were comparable.The total scores of MMSE.NPI.ADL.Clinical Dementia Rating Scale(CDR).HIS,NIHSS.Hamilton Depression Scale(HAMD)and TCM syndrome Scale between the experimental group and the control group before intervention were not statistically different(P<0.05).with comparability.2.Scale evaluation and comparison before and after treatment:2.1 Neurological function:After treatment,there were statistically significant differences in NIHSS and NPI scores between the two groups(P<0.01).There were statistically significant differences in NIHSS scores between the two groups(P<0.05),and no statistically significant differences in NPI scores between the two groups(P>0.05).In terms of efficacy evaluation of NIHSS.the effective rates of the two groups were 89.41%and 64.37%respectively,with statistical difference(P<0.05).There was no significant difference in NPI integral efficiency between the two groups(P>0.05).2.2 In terms of cognitive function,the total MMSE score of the two groups was significantly higher than that before treatment(P<0.01).In the single integral comparison of MMSE.experimental time orientation,immediate memory and delayed memory,language comprehension,depending on the spatial perception,retelling and integral,integral calculation and attention,reading writing before treatment were increased(P<0.01 or p<0.05);In the control group,immediate memory,delayed memory,language comprehension,visuospatial perception,and retelling score were higher than before treatment(P<0.01).The difference of MMSE total score between the two groups after treatment was statistically significant(P<0.05).A single comparison,two groups of language comprehension,repetition,writing,reading,integral,delayed memory score was statistically difference(P<0.01 or P<0.05).After treatment,the effective rates of MMSE in the two groups were 49.4%and 34.5%,respectively,with statistical difference(P<0.05).2.3 Assessment of daily living ability:the difference of ADL score between the two groups was statistically significant(P<0.01).There was no significant difference in ADL scores between the two groups(P>0.05).In terms of efficacy evaluation,the effective rates of the experimental group and the control group were 24.7%and 28.7%respectively,which were not statistically significant(P>0.05).2.4 Evaluation of syndromes:(1)Comparison of total scores of TCM syndromes scale:Compared within the group.the total scores of main symptoms and syndromes in the TCM syndromes scale of the two groups and the total scores of secondary symptoms in the experimental group were statistically significant(P<0.01).Compared between the two groups.the total score of TCM syndromes and the total score of TCM syndromes were statistically different between the two groups(P<0.05).(2)Comparison of single score of main symptoms in TCM syndrome scale:Comparison within the group showed that the score of main symptoms in the test group was significantly different from that before treatment(P<0.01)in terms of"decreased intelligence","weak waist and knees" and "irritability"(P<0.01).In the control group,the scores of main symptoms including "decreased intelligence","weak waist and knees" and "stiff expression and silence" were statistically significant(P<0.01).Compared between the two groups,the differences in scores of "mental retardation" and "restlessness" between the two groups after treatment were statistically significant(P<0.01).(3)Comparison of single score of subscale of TCM syndromes:Comparing within the group.the scores of "moody","cyanosis","palpitation" and "nocturia" in the test group were statistically significant(P<0.01 or P<0.05).In the control group,the scores of "extremities with acute and minor anesthesia","palpitations" and "tinnitus" were low er than those before treatment,with statistical difference(P<0.05).The differences in "moodiness" and "cyanosis" scores between the two groups were statistically significant(P<0.01 or P<0.05).(4)Evaluation and comparison of the total scores of TCM syndromes:the effective rates of the total scores of TCM syndromes in the two groups were 67.1%and 46.0%.respectively,with significant statistical significance(P<0.01).The total effective rates of the two groups were 74.12%and 55.17%,respectively,with statistical significance(P<0.05).3.Comparison of serological indicators:NSE:(1)Within the group,two groups of NSE protein expression levels before treatment were significantly decreased(P<0.01);The difference between the two groups was statistically significant(P<0.05).(2)BDNF:The expression level of BDNF protein was significantly increased in both groups(P<0.01).After treatment the difference between the two groups was statistically significant(P<0.05).(3)Hcy:Comparing group,two groups of Hey protein expression levels before treatment were significantly decreased(P<0.01).There was no significant difference between the two groups after treatment(P>0.05).4.Safety evaluation:Two groups of patients with no significant changes in vital signs before and after medication safety testing before and after the intervention,the blood routine,urine routine,liver and kidney function and electrocardiogram(ecg)has no obvious change,to change are within the normal range.Conclusion1.Traditional Chinese medicine compound shenma yizhi recipe combined with ginkgo biloba leaves can effectively improve the symptoms of neurological functional defects in patients with mild to moderate vascular dementia,and it has safety.2.Traditional Chinese medicine compound shenma yizhi recipe combined with ginkgo biloba leaf can improve mild and moderate vascular dementia,the nerve function defect may be related to the improvement of nerve blood supply. |
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