| Objective:1.This literature study was conducted to systematically review and evaluate the efficacy of the method of benefiting Qi,nourishing Yin,and activating Blood in the treatment of diabetic cardiomyopathy.The purpose is to guide more clinical studies and provide valuable experience for clinical treatment.2.This clinical study was conducted to observe the clinical efficacy of Danzhi Jiangtang Capsule with the efficacy of benefiting Qi,nourishing Yin and activating Blood in treating patients with type 2 diabetic cardiomyopathy and its effect on the patients’ Insulin resistance status and oxidative stress level.3.Animal experiments were conducted to construct diabetic cardiomyopathy model rats,to study the effects of Danzhi Jiangtang Capsule on the oxidative stress status and pancreatic Insulin resistance of the model rats’ cardiomyocytes,and the effects of Danzhi Jiangtang Capsule on the AMPK/SIRT-1 pathway in the rats’ myocardial tissues,and to analyze the potential mechanisms of its therapeutic effects.Methods:1.Literature system analysisThrough computer search,the search terms related to this study were used to search articles in the literature database;After formulating the literature selection and exclusion criteria,the selected articles are counted in the Excel table in WPS,and the title,author name,and publication year are marked.The included studies were assessed for bias in the Cochrane Manual of Systematic Reviews and the contents of this study were extracted.The statistical research data is analyzed in Review Manager 5.2.2.Clinical observationForty-eight subjects with type 2 diabetic cardiomyopathy with Qi and Yin deficiency and stasis were divided into 24 patients in the control group and 24 patients in the treatment group by random number table.The clinical efficacy of DJC in the treatment of this disease was evaluated by comparing the TCM syndrome score,blood glucose and lipid levels,cardiac ultrasonography,brain urinary natriuretic peptide,oxidative stress-related indexes and Insulin resistance status before and after the administration of DJC to the subjects in both groups.3.Animal experimentFirst,80 SD rats were randomly selected as the blank(NC)group,and the remaining 70 rats were modeled by a combination of high sugar and high fat diet and single intraperitoneal injection of streptozotocin.The rats were divided into the model(MC)group,the low,medium and high doses(L-DJC,M-DJC,H-DJC)of Danzhi Jiangtang Capsules,and the metformin(Met)group;the medication group was treated with the corresponding drug doses by daily gavage;the rats in the NC and MC groups were gavaged with distilled water.All the rats in the above six groups were intervened for 8weeks.At the end of the experiment,the rats were collected and tested for glucose,lipids,oxidative stress,fasting insulin,etc,pathological staining,and determination of the expression of related proteins.Results:1.Results of literature system analysis(1)According to the search strategy,a total of 4627 papers were examined,and a total of 38 studies were finally included.A total of 3305 patients were included in the 38 included studies,of which 1658 patients were counted in the observation group and1647 in the control group in total.(2)In the clinical efficacy statistics 29 literature were included,and the analysis results supported the treatment group(P < 0.00001),indicating that the clinical efficiency of the method of benefiting Qi,nourishing Yin and activating Blood in the treatment of DCM was higher than that of the Western medicine control group.(3)Twenty-one studies reported left heart ejection fraction;3 studies reported ejection fraction;15 studies reported E/A;13 studies reported left ventricular end-diastolic internal diameter;5 studies reported left ventricular end-systolic internal diameter;and6 studies reported 6-minute walk test distance.The analysis showed that for improving cardiac function indexes in patients with DCM,the Yi Qi,Yin,and Blood method treatment group was superior to the Western medicine control group(P< 0.00001).(4)Four studies reported B-type natriuretic peptide;eight studies reported amino-terminal brain natriuretic peptide precursors.After analysis,for the reduction of heart failure markers after treatment in DCM patients,the Yi Qi,Yin,and Blood method treatment group was superior to the Western medicine control group(P < 0.00001).(5)Four studies reported indicators related to heart rate variability.After analysis,the improvement of indexes in the group treated with the Beneficial Qi,Nourishing Yin and Invigorating Blood method was better than that in the Western medicine control group(P=0.006).(6)Twelve studies had comparisons of fasting blood glucose;nine studies had comparisons of 2-hour postprandial blood glucose,and after analysis of blood glucose levels,the Yi Qi,Yang Yin,and Blood Activation Method treatment group was superior to the control group(P < 0.00001).(7)Thirteen studies had comparisons of total serum cholesterol;12 studies had comparisons of triglycerides;11 studies had comparisons of LDL cholesterol;and 8studies had comparisons of HDL cholesterol.The results of analyzing the lipid-related indexes showed that the treatment group was better than the control group(P < 0.00001)in the method of benefiting Qi,nourishing Yin and activating blood.(8)Seven studies had comparisons of superoxide dismutase;five studies had comparisons of glutathione peroxidase,and the results of the analyses showed that for the improvement of the indexes,the group treated with the Yi Qi and Yin method was better than the control group(P < 0.0001/P < 0.00001).(9)Six studies had a comparison of C-reactive protein.The results of the analysis showed that the group treated with the Beneficial Qi,Nourishing Yin and Invigorating Blood method was better than the control group(P < 0.00001).2.Clinical observation results(1)After the intervention,the evidence points of patients in both groups decreased significantly;and the evidence points of patients in the treatment group with DJC were lower than those in the control group(P < 0.01).(2)Patients in both groups showed improvement in blood glucose and other indicators after receiving the corresponding treatment compared with those before treatment(P <0.05 or P < 0.01).The comparison of the two indicators of blood glucose between groups showed that the decrease of indicators was more obvious in the treatment group(P < 0.05 or P < 0.01).(3)Compared with the NC group,all the remaining groups showed different degrees of abnormal lipid levels(P<0.05);compared with the model group,the four lipid indexes in the Met and DJC-H groups improved significantly(P<0.05),while triglycerides and HDL in the DJC-L group improved significantly compared with the model group(P<0.05).(4)The left ventricular end-diastolic internal diameter and ejection fraction improved in the treated group after treatment(P < 0.01),while no significant improvement was seen in these two indexes in the control group(P > 0.05).In the comparison between groups after treatment,the results of ejection fraction index were better in the treatment group(P < 0.05).(5)The B-type natriuretic peptide level improved in both groups after treatment(P <0.01)and the improvement was better in the treatment group(P < 0.05).(6)The levels of superoxide dismutase and glutathione peroxidase were found to increase after treatment in both groups(P < 0.01);the treatment group showed better improvement(P < 0.05).(7)In the comparison before and after treatment,the fasting insulin and insulin resistance index steady-state model assessment was found to be reduced in both groups(P < 0.05 or P < 0.01);the improvement of the two indexes was better in the treatment group in the comparison between groups(P < 0.01 or P < 0.05).(8)After the intervention of related measures in both groups,the effective rate of the treatment group(86.96%)was better than that of the control group(59.09%),and the difference was statistically significant.3.Results of animal experiments(1)With the lengthening of the drug intervention time,the overall status of rats in the metformin group and each dose of Danzhi Jiangtang Capsule group improved.(2)Before the corresponding drug intervention,the fasting blood glucose of rats in the remaining groups increased significantly compared with that in the NC group(P < 0.01);there was no difference between the fasting blood glucose of rats in each drug group except the NC and the MC group(P>0.05).After 8 weeks of drug intervention,compared with the fasting blood glucose of rats in MC group,the blood glucose of Met group decreased significantly(P<0.01);compared with the fasting blood glucose of rats in MC group,the fasting blood glucose level of rats in M-DJC group and H-DJC group decreased(P<0.05).(3)Compared with the NC group,all the remaining groups showed different degrees of abnormal lipid levels(P<0.05);compared with the MC group,the four lipid indexes in the Met and DJC-H groups improved significantly(P<0.05),while triglycerides and HDL in the DJC-L group improved significantly compared with the MC group(P<0.05).(4)Compared with the NC group,the serum FINS of rats in the MC,L-DJC and M-DJC groups increased significantly(P < 0.01);compared with the MC group,the serum insulin of rats in the medicated group decreased to different degrees(P<0.01);when comparing the HOMA-IR index,the MC group was significantly higher than the NC group(P<0.01);compared with the MC,the HOMA-IR index of rats in the medicated group was lower(P<0.01).The HOMA-IR index was lower in the MC group than in the NC group(P< 0.01).(5)A more significant decrease in malondialdehyde content was seen in the rats of the drug-administered group(P< 0.01);the serum superoxide dismutase activity values were higher in the drug-intervention group than in the MC group(P < 0.01).(6)After 8 weeks of corresponding drug intervention,the serum levels of B-type natriuretic peptide were higher in the MC group rats than in the NC group(P< 0.01);the serum levels of BNP were lower in the remaining four model groups rats than in the MC group(P< 0.01).(7)HE and Sirius red staining: The morphological changes of myocardium were observed in each group of rats,and the degree of myocardial injury was reduced in each group after drug intervention compared with the MC group.(8)Western Blot assay results: AMPK,SIRT1,PGC-1α,IRS1 protein expression were significantly increased in each group of drug intervention compared with the MC group;the protein expression of CTGF was decreased(P< 0.01).Conclusions:After meta-analysis,it was found that the treatment group with conventional symptomatic treatment of Western medicine combined with qi and blood invigorating traditional Chinese medicine achieved better clinical efficacy.The improvement of major indicators such as heart function,heart failure markers,heart rate variability,blood glucose,blood lipids,oxidative stress,and inflammatory factors was also better than that of the control group.DJC with the efficacy of benefiting Qi,nourishing Yin and activating blood circulation has clinical efficacy in improving clinical symptoms,reducing the evidence score,regulating glucolipid metabolism,improving Insulin resistance,reducing oxidative stress damage and protecting cardiac function in DCM patients with Qi and Yin deficiency with stasis evidence.From the analysis of animal experimental results,it may be that by activating the AMPK/SIRT1 pathway,PGC-1α protein is increased,insulin resistance and oxidative stress damage is improved,and the degree of myocardial fibrosis is reduced,thereby protecting cardiac function and delaying the progression of DCM.. |