| Vascular dementia(VD)is a type of cognitive impairment caused by the embolism or rupture of a blood vessel in the brain,and the incidence of dementia is gradually increasing as the problem of ageing increases.Most doctors believe that the basic mechanism of the disease is based on deficiency of the liver and kidney,phlegm and stagnation of the orifices,and hyperactivity of the liver and yang.Tianzhi Granules can nourish the liver and kidney,remove phlegm and stasis,pacify the liver and subdue yang,and clear heat and lower fire.The ingredients of Tianzhi Granules include Tianma,Hooked Vine,Shijiazhuang,Eucommia,Mulberry,Fu Shen,Shou Wu Tang,Sophora,Gardenia,Scutellaria,Chuan Niu Kne,and Yimu Cao.It has achieved some efficacy in the treatment of vascular dementia in clinical practice.In this study,the clinical efficacy and safety of Tianzhi Granules in the treatment of vascular dementia will be evaluated using both the evidence-based evaluation method of Meta-analysis and a prospective clinical cohort study of patients.Objectives1.to evaluate the efficacy and safety of Tianzhi Granules in the treatment of vascular dementia in an evidence-based manner.2.clinical retrospective cohort study on the effect and safety of Tianzhi granules in the treatment of mild to moderate vascular dementia.Methods1.Meta-analysis:Computer search searched Cochrane,PubMed,Embase,China Biomedical Literature Database,China Knowledge Network,Vipshop,Wanfang database to collect relevant literature on Tianzhi granules for the treatment of vascular dementia from 2010.1 to 2020.12.The literature was screened according to the inclusion and exclusion criteria established,and the final qualified literature was analyzed using Rev Man5.3 for data analysis.2.Clinical prospective cohort study.A prospective cohort study was carried out on 60 VD patients who met the inclusion criteria.According to whether the patients took Tianzhi granule orally,they were divided into exposed group and non-exposed group,with 30 cases in each group.Non-exposed group received conventional western medicine treatment,and symptomatic treatment such as inhibiting platelet aggregation,lowering glucose and blood pressure,improving cerebral circulation.The exposed group was treated with Tianzhi granules on top of this treatment for a total of 12 weeks.Before treatment and after 12 weeks of treatment,the patients with VD were given the scores and measurements of the mini-mental state examination(MMSE)and activities of daily living(ADL),and the patients’ blood,urine,stool routine,liver function and electrocardiogram were observed respectively.A safety index was used.The results were analysed using SPSS 23.0statistical software.Results1.Meta-analysis:Compared with the control group,the MMSE score[MD=1.70,P=0.006] improved more significantly in the treatment group using Tianzhi pellets,suggesting that Tianzhi pellets could improve the cognitive function of the patients.The ADL scores of the treatment and control groups were statistically significant [RR=-2.66,Z=5.50,P=<0.00001].It indicates that the administration of Tianzhi granules can improve the patients’ ability to perform daily living.2.Clinical prospective cohort study:There were 30 cases each in the exposed group and the non-exposed group.There was no statistical significance in terms of age,gender and education level of the patients in the two groups before treatment,which were comparable(P>0.05).The MMSE and ADL score scales before treatment were not statistically significant in both groups(P>0.05).After 12 weeks of treatment,there was a statistically significant difference between the MMSE and ADL score scale scores of the two groups(P<0.05),indicating that the efficacy of the exposed group was better than that of the non-exposed group.No significant abnormalities were found in the routine examination and laboratory index tests,indicating that Ming Ming Zhi granules have a good safety profile.Conclusion:In this study,when meta-analysis was performed,it was found that the MMSE score and ADL score in the treatment group were significantly higher than those in the control group.Tianzhi Granules can effectively improve the cognitive ability and quality of life of patients with good safety,indicating that this product has good clinical indications and can be further promoted.A retrospective clinical cohort study has recently confirmed that Tianzhi Granules can improve cognitive function and daily living ability in mild to moderate middle-aged and elderly patients with vascular dementia with a good safety profile. |
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