A Clinical Study On The Treatment Of Mild To Moderate Vascular Dementia In Spleen And Kidney Deficiency Type With Zhinao Capsules Based On Cerebral Haemodynamics

Purpose This study was conducted to investigate the clinical efficacy of Zhinao Capsule on cerebral haemodynamics,cognitive level,daily living ability and serum inflammatory response level in mild to moderate vascular dementia(Va D)patients with spleen and kidney deficiency,and to provide clinical basis and theoretical support for the treatment of Va D with Zhinao Capsule in the field of Chinese medicine.MethodsThe cases in this study were obtained from Va D patients at the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine’s Brain Disease Centre.70 patients with mild or moderate Va D of the spleen and kidney deficiency type who met the criteria for nadir were selected.All subjects were divided into control and treatment groups according to the randomised control principle,with 35 cases in each group.For treatment,Donepezil Hydrochloride Tablets were given orally as the basic treatment to the control group,while the treatment group was given Zhinnao Capsules orally on top of this.Before and after treatment,ultrasound cerebral function instrument was used to measure the changes of the maximum flow velocity(Vmax),minimum flow velocity(Vmin),peripheral resistance(Rv),dynamic resistance(Dr)and other ultrasound cerebral haemodynamic indexes in both sides of the common carotid artery of the patients;and the Mini Mental State Examination(MMSE <see Table 1>),the Clinical Dementia Rating(CDR,<See Exhibit 2>),Montreal Cognitive Assessment(Mo CA,<See Exhibit 3>),(Addenbrooke ’ s Cognitive Examination,ACE-III,<See Exhibit 4>),the Activities of Daily Living(ADL <See Exhibit 5>),the Hachinski ischemic score(HIS <See Exhibit 6>),and compared the MMSE,Mo CA,ACE-III,and ADL before and after treatment.The changes of homocysteine(Hcy),serum amyloid A(SAA),superoxide dismutase(SOD)and super-sensitive C-reactive protein(hs-CRP)and other related vascular inflammatory indexes were compared before and after the treatment;the Chinese medicine symptom scores and clinical efficacy of Zhinao capsule on patients with mild to moderate Va D with deficiency of both spleen and kidney were observed.Results1.Effect of Zhinao Capsules on cerebral hemodynamics: Vmax and Vmin of bilateral carotid arteries in the treatment group and control group increased significantly after treatment compared with those before treatment,and cerebrovascular blood flow velocity in the treatment group improved more significantly after treatment(P<0.05);Rv and Dr of bilateral common carotid arteries in the treatment group and control group decreased significantly after treatment compared with those before treatment(P<0.05),and patients in the treatment group improved more significantly after treatment(P<0.05).The improvement in Rv and Dr was more significant in the treatment group than in the control group(P<0.05);the cerebral function score was significantly higher in the treatment group and the control group than before treatment(P<0.05),and the improvement in cerebrovascular function score was more significant in the treatment group(P<0.05).2.Effect of Zhinao Capsules on cognitive function: MMSE scores increased in both treatment and control groups after treatment(P<0.05),and MMSE scores improved more significantly after 16 and 24 weekends of treatment in the treatment group(P<0.05);Mo CA scores increased in both treatment and control groups after treatment(P<0.05),and Mo CA scores improved more significantly after 16 and 24 weekends of treatment in the treatment group(P<0.05);ACE-III scores increased in both treatment and control groups(P<0.05),and ACE-III scores improved in both treatment and control groups(P<0.05).Mo CA scores increased more significantly(P<0.05);ACE-III scores increased in both treatment and control groups compared to pre-treatment(P<0.05),and ACE-III scores increased more significantly(P<0.05)in the treatment group after 24 weekends of treatment.3.Effect of Zhinao Capsules on the ability of daily living: ADL scores increased in both the treatment and control groups after treatment compared with those before treatment(P<0.05),and the increase in scores in the treatment group was more significant and the treatment efficiency was higher(P<0.05).4.Effect of Zhinao Capsules on serum SAA,SOD,Hcy and hs-CRP levels: after treatment,serum SAA,SOD and Hcy levels of subjects in both groups were lower than before treatment(P<0.05),with Hcy and hs-CRP levels improving more significantly in the treatment group(all P<0.05).5.Effect of Zhinao capsules on the symptoms of Chinese medicine of the type of deficiency of spleen and kidney: the effective rate of the treatment group was 90.63%and that of the control group was 77.42%(P < 0.05).6.Effect of Zhinao Capsules on clinical efficacy: the clinical efficacy rate of the treatment group was 87.5% and that of the control group was 74.2%.P < 0.05 for the comparison of clinical efficacy between the two groups of subjects.Conclusions1.Zhinao Capsules can improve cerebrovascular function by effectively improving blood flow velocity,reducing peripheral resistance to improve small and medium-sized blood vessel patency,and reducing dynamic resistance to improve vascular self-regulation,thus enhancing cerebrovascular function to a better extent than the control group.2.Zhinao Capsules can improve the TCM symptoms of patients with mild to moderate Va D of the spleen and kidney deficiency type,providing clinical basis and theoretical support for the treatment in the field of TCM.3.Zhinao Capsules improve the cognitive level and daily living ability of patients and can be more effective in improving the clinical symptoms of dementia patients.4.Zhinao Capsules improved serum inflammation levels in dementia patients more effectively than the control group.