Clinical Study Of Shenma Yizhi Decoction In The Treatment Of Mild And Moderate Vascular Dementia Of Qi-Deficiency Blood Stasis And Liver-Yang Hyperactivity

Vascular dementia(VaD or VD)refers to cognitive dysfunction syndrome due to stroke or hypoperfusion in the brain.According to domestic epidemiological surveys,the prevalence of VD in China is 1.1%-3.0%,and the annual incidence rate is 5-9/1000,which seriously endangers people’s life and health and reduces people’s quality of life.At present,there is no complete cure for vascular dementia,and it is the only type of dementia that can be controlled.The majority of Chinese medicine scholars are also actively exploring more effective treatments.In this regard,we carried out the following research.ObjectiveThis study aims to evaluate the clinical efficacy and safety of Chinese herbal compound Shenma Yizhi Decoction(SMYZ)in patients with Mild and Moderate Vascular Dementia of Qi-Deficiency Blood Stasis and Liver-Yang Hyperactivity.Furthermore explore its possible mechanism through the serum markers and hemorheology indexes.MethodsIn accordance with the principle of evidence-based medicine,randomized controlled clinical trials were used to select 60 patients with VD who met the inclusion criteria in Jingzhuang community hospital,Xiaoshizhuang Village Health Center and Xiyuan Hospital wards.The patients were randomly divided into experimental group and control group.Each group had 30 patients.The experimental group was given SMYZ and the control group was given ginkgo tablet for 3 months.Before the test,3 months after the test,neuropsychological scale,daily living ability,degree of neurological deficit.TCM syndrome scale,serum central cholinergic system,oxidative stress level,inflammatory factor,hemodynamics were studied to observe the clinical efficacy of SMYZ.Besides,before the test,test 1.5 months,test 3 months,the patient’s blood,urine routine,liver and kidney function and ECG and other safety indicators were monitored to observe the drug safety.Results1.Before treatment,the baseline data of gender,age,body mass index(BMI),education level,heart rate,past medical history and other data were not statistically different(P>0.05).The two groups were comparable.2.Three months after treatment,the scores of Mini Mental State Examination(MMSE),the Montreal Cognitive Assessment(MoCA),and the Daily Life Ability Scale(Activity of Daily),Living Scale(ADL),National Institute of Health stroke scale(NIHSS)and TCM syndrome scores were all improved in 2 groups(P<0.01).Among them,the improvement of scores of experimental group in MMSE,ADL,NIHSS,TCM Syndrome Scale was better than that in control group(P<0.05).After treatment,the two groups showed significant improvement in delayed memory scores of MMSE(P<0.05).Besides,the experimental group had significantly higher scores in computational power and attention after treatment(P<0.05).Comparing various points of MoCA,the visual acuity,executive ability and delayed recall of the experimental group were significantly improved(P<0.05).The scores of the main symptoms of the TCM symptom scales of"dizziness","body voice","extreme numbness","lips,and nails cyanoze" were all lower than those before treatment(P<0.05);The scores of "intelligence" and"dizziness" of experimental group were more significant than those of the control group(P<0.05).In terms of efficacy,after treatment,the efficacy of the MMSE,NIHSS,and TCM syndrome scales of the experimental group was better than that of the control group(P<0.05).The effective rates were 50.0%,43.3%,and 60%for the experimental group and 23.3%,13.3%,16.7%for the control group,respectively.There was no significant difference in the efficacy of MoCA and ADL between the two groups(P>0.05).The effective rates were 63.6%,73.3%in the experimental group and 53.3%,60%in the control group.3.Serological indicators:After treatment,serum acetylcholine(Ach)levels were elevated(P<0.01),acetylcholinesterase(AchE)levels were decreased(P<0.01),and the experimental group Better than the control group(P<0.05).The levels of serum superoxide dismutase(SOD)and glutathione peroxidase(GSH-Px)in patients were higher than those before treatment(P<0.05),malondialdehyde(MDA)was lower than that before treatment(P<0.01),and there was no significant difference in SOD,MDA and GSH-PX between the two groups after treatment(P>0.05).The levels of interleukin-6(IL-6)in both groups were lower than that before treatment(P<0.01),and there was no statistical difference between the two groups after treatment(P>0.05).The Tumor Necrosis Factor-alpha(TNF-α)content in the experimental group was decreased(P<0.05),which was significantly higher than that in the control group(P<0.01).4.In terms of hemorheology,the blood viscosity of the two groups was lower than that before treatment(P<0.01)when the shear rate was 1.0s-1 and5.0s-1 after 3 months of treatment.The erythrocyte aggregation index and red blood cell deformation rate were improved(P<0.01).The red blood cell deformation rate of the control group was higher than that before the drug(P<0.05).The platelet aggregation rate and adhesion rate of the two groups were lower than before treatment(P<0.01).Between 2 groups after the drug,the shear rate was 1.0 s-1,the blood viscosity of the control group improved more significantly than the experimental group(P<0.05),and there was no significant difference in other items between two groups(P<0.05).5.Safety evaluation:There was no adverse reaction in the test group.Conclusions1.SMYZ is superior to Ginkgo biloba leaves in the treatment of mild to moderate vascular dementia.It can improve cognitive function,especially in the aspects of delayed memory,computational power and attention,visual acuity and executive ability.It can improve daily life,relieve neurological deficits,and improve the TCM symptom such as forgetfulness,dizziness,numbness,cyanosis.The mechanism may be related to improving the hemodynamics of patients,regulating the central cholinergic system,inhibiting inflammation and oxidative stress.In the aspect of improving TCM symptoms of Qi-Deficiency Blood Stasis and Liver-Yang Hyperactivity and regulating the function of central cholinergic system,SMYZ is superior to ginkgo tablet.2.SMYZ has good safety and there were no adverse reactions such as liver and kidney dysfunction.