Clinical Effects Of Guilingji Capsule On Patients With Vascular Mild Cognitive Impairment

Vascular mild cognitive impairment(Va MCI)is a syndrome of mild cognitive impairment caused by or related to vascular impairment.It is a transitional stage between normal cognition and dementia.At present,with the acceleration of the aing process of China’s population,the incidence of cognitive dysfunction is also increasing day by day,if the disease is not timely early intervention,the risk of developing into vascular dementia is significantly increased,and it will reduce the quality of life of patients and bring heavy care and economic burden to families and society.Va MCI as the early stage of dementia,is an important target to prevent disease progression,its early condition is reversible,and the theory of preventing disease by traditional Chinese medicine has unique advantages in this respect.Traditional Chinese medicine has fewer side effects,it can prevent and cure diseases through different ways from multiple perspectives,which is more in line with the multi-factor and multi-mechanism characteristics of the disease.Therefore,more and more researchers turn their research to traditional Chinese medicine.Research purpose:To evaluate the clinical efficacy of Guilingji capsule in the treatment of vascular mild cognitive impairment(kidney deficient encephala reduce),and to monitor its adverse reactions and safety.In this study,a randomized,double-blind,double-simulated,positive control method was used to select 96 patients with Va MCI who met the inclusion criteria and were divided into experimental group and control group,with 48 patients in each group.The experimental group was given Guilingji capsule combined with Ginkgo biloba leaf simulant,and the control group was given Guilingji simulant combined with Ginkgo biloba leaf for 24 consecutive weeks.Compare the data before and after the experiment about the Montreal Cognitive Assessment Scale(Mo CA),the Minimum Mental State Examinition Scale(MMSE),the Alzheimer’s Disease Assessment Scale-Cognitive Subscale(ADAS-Cog)the TCM syndrome scoring scale,serum levels of Acetylcholine(Ach),serum levels of Acetylcholinesterase(Ach E),serum levels of Homocysteine(Hcy),serum levels of high sensitivity C-reaction protein(hs CRP).At the same time,blood test,urine routine test,stool routine,liver and kidney function,ECG of the patients were detected,and adverse events were observed and recorded.Results:1.Baseline data analysis:Before treatment,the general information of patients in the two groups were compared,including gender,age,height,weight,Body Mass Index(BMI),education level,accompanying diseases,brain CT,Acticity of Daily Living Scale(ADL),Hachinski(HIS)and Clinical Dementia Rating(CDR),there were no statistical differences(P>0.05)in these aspects,they were comparable.There were no statistical differences in Mo CA,MMSE,ADAS-Cog,TCM syndrome scoring scale and serum levels of Ach,Ach E,Hcy and hs CRP between two groups(P>0.05),they were comparable.2.The effect of Guilingji on cognitive function:(1)The effect of Guilingji on Mo CA with Va MCI: after 12 weeks and 24 weeks of treatment,the Mo CA scores of the two groups were higher than those before treatment(P<0.01);Compared between the two groups,there was no significantResearch methods:difference in Mo CA scores between the two groups after 12 weeks of treatment(P>0.05),but there was significant difference in Mo CA scores between the two groups after 24 weeks of treatment(P<0.01).(2)The effect of Guilingji on MMSE with Va MCI: after 12 weeks and 24 weeks of treatment,the MMSE scores of the two groups were higher than those before treatment(P < 0.01).Compared between groups,there was no significant difference in MMSE scores between the two groups after 12 weeks of treatment(P>0.05),but there was significant difference in MMSE scores between the two groups after 24 weeks of treatment(P<0.05).(3)The effect of Guilingji on ADAS-Cog with Va MCI: after 12 weeks and 24 weeks of treatment,the ADAS-Cog scores of the two groups were lower than those before treatment,(P<0.01).Compared between the two groups,there was no significant difference in ADAS-Cog scores between the two groups after 12 weeks of treatment and 24 weeks of treatment(P>0.05).3.The effect of Guilingji on TCM syndrome scoring scale with Va MCI:After24 weeks of treatment,the TCM syndrome scoring scale of both groups were lower than those before treatment(P<0.01).Compared with the control group,after24 weeks of treatment,the effective rates of "intelligence decline","soreness of waist and knees" and "listlessness and drowsiness" in the experimental group were significantly different from those in the control group(P<0.01),while the effective rates of "stiff expression" in the control group were significantly different(P < 0.01),other differences were no statistically significant(P>0.05).4.The effect of Guilingji on serum indexes with Va MCI:(1)Ach:After 24 weeks of treatment,the serum levels of Ach about the two groups was higher than that before treatment,(P<0.01).Compared between the two groups,after 24 weeks of treatment,there was a significant difference in serum levels of Ach between the two groups(P<0.01).(2)Ach E:After 24 weeks of treatment,the serum levels of Ach E in both groups were decreased compared with that before treatment(P<0.01).After 24 weeks of treatment,there was no significant difference in serum levels of Ach E between the two groups(P>0.05).(3)Hcy:After 24 weeks of treatment,the serum levels of Hcy in both groups were decreased compared with that before treatment(P<0.01).After 24 weeks of treatment,there was a significant difference in serum levels of Hcy between the two groups(P<0.01).(4)hs CRP:After 24 weeks of treatment,the serum levels of hs CRP in both groups were decreased compared with that before treatment(P<0.01).After 24 weeks of treatment,there was no significant difference in serum levels of hs CRP between the two groups(P>0.05).5.Safety evaluation:Before and after treatment,there were no obvious abnormal changes in blood test,urine routine test,stool routine,liver function(ALT,AST),kidney function(CRE,BUN)and ECG,and no serious adverse reactions occurred during the medication,which proved that Guilingji has clinical safety.6.Follow-up results:After 24 weeks’ follow-up,no adverse reactions and adverse events occurred.Conclusion:Guilingji capsule can improve the cognitive function of patients with vascular mild cognitive impairment(kidney deficient encephala reduce),and has no effect on blood,urine,stool routine,liver and kidney function and ECG of patients.Therefore,Guilingji capsule is effective and safe in clinical application.