The Real-world Clinical Study Of Naoxintong Capsule In The Treatment Of Diabetic Kidney Disease

ObjectiveDiabetic kidney disease(DKD)is one of the most important microvascular complications of diabetes and the main cause of end-stage renal disease.The increasing incidence of DKD has placed a heavy burden on public health,as well as tremendous economic pressure on families and society.Traditional Chinese medicine(TCM)has unique advantages in the treatment of DKD.Naoxintong Capsules are also increasingly prescribed in the treatment of DKD,which has shown clinical value.Therefore,based on the medical big data platform in Tianjin,we evaluated and explored the effectiveness and safety of Naoxintong capsule in the treatment of DKD in a real clinical setting through a real-world retrospective cohort study,so as to provide reliable clinical basis for the intervention of Naoxintong capsule in DKD,further expand drug indications,and promote clinical application.MethodA total of 1,798 patients with DKD were included in the real-world retrospective cohort study.The patient data was obtained from an online medical data platform.Subjects included in the study were divided into high,medium,low exposure group and non-exposure group according to whether they took Naoxintong Capsule and the cumulative duration of taking it.Baseline indexes of each group were extracted and matched with propensity scores to control confounding factors.The eGFR,heart and kidney-related end points,CKD staging changes and safety indexes were evaluated to analyze the clinical efficacy and safety of Naoxintong capsule on DKD.In this study,SPSS 22.0 and R 3.6.2 were used to analyze and process the data.Results(1)A total of 1,798 subjects were included,among them were 799 patients in the exposed group and 799 patients in the non-exposed group.After the propensity score matching(PSM),there was no statistical significance in the general situation and efficacy indexes between the two groups in the baseline(P<0.05).(2)The improvement of eGFR:Comparing two groups of patients with the eGFR in the endpoint and the eGFR difference before and after treatment,we found that the endpoint eGFR in exposed group was obviously higher than that of control group(P<0.05).eGFR of DKD patients taking Naoxintong capsule decreased by 1.46±21.94 ml/min·(1.73m2)-1,while that of the control group decreased by 5.82 ± 19.8 ml/min·(1.73m2)-1.It could be observed that the application of Naoxintong capsule significantly alleviated the downward trend of eGFR,and the difference was statistically significant(P<0.05).In addition,the trend of eGFR change indicated that the decrease of glomerular filtration rate was slowed after taking Naoxintong Capsule.(3)The improvement of the end-point events:Survival analysis of end-point renal composite showed a more gradual decline in the survival curve in the medication group,with a median survival time of 929.5 days in the Naoxintong group versus 575.5 days in the control group(HR=0.71,95%CI:0.55-0.92,P=0.0088).Survival analysis of the outcome of renal deterioration showed a gentle decline in the survival curve,with a median survival time of 1020 days in the Naoxintong group versus 660 days in the control group(HR=0.74,95%CI:0.56-0.99,p=0.041).Survival analysis of major adverse cardiovascular events showed that the survival curve of patients in the medication group decreased more gently than that in the control group,and the median survival time in the Naoxintong group was 1027 days,compared with 686 days in the control group(HR=0.61,95%CI:0.45-0.82).The survival time of hospitalization events for heart failure basically coincided between the two groups,and the median survival time of exposed group and non-exposed group was 807 days and 528 days,respectively(HR=0.9,95%CI:0.88-1.4).The difference was not statistically significant(P=0.63).(4)Improvement in CKD staging:269 patients in the exposed group recovered to the stage of CKD1 after treatment,compared with 159 patients in the non-exposed group,indicating significant improvement in eGFR.The overall improvement rate of CKD stage in exposure group was 34.04%,which was higher than that in control group(22.36%).The overall progression rate of CKD stage in the exposed group was 21.25%,lower than 24.92%in the control group.(5)Effects on renal function,blood glucose and blood lipid:There were no significant differences in urea nitrogen,uric acid,fasting blood glucose,glycosylated hemoglobin,high density lipoprotein and triglyceride between the two groups before and after treatment(P>0.05).Before and after treatment,the increase of serum creatinine in the exposed group was 17.911± 106.3 μmol/L,while that in the control group was 27.03 8± 123.12 μmol/L.Naoxintong capsule effectively improved the increase of serum creatinine,and the difference was statistically significant(p<0.05).After treatment,low density lipoprotein in exposure group decreased by 0.25±1.11mmol/L,which was higher than that in control group by 0.02±1.03mmol/L,and the difference was statistically significant(p<0.05).Before and after treatment,total cholesterol in exposure group decreased by 0.43± 1.43 mmol/L,which was higher than that in control group by 0.24±1.36 mmol/L,and the difference was statistically significant(p<0.05).(6)Safety analysis:Before and after treatment,there were no significant differences in blood routine indexes of red blood cells,white blood cells,and platelets,liver function indexes of ALT,AST,ALP,total bilirubin,and transpeptidase,and electrolyte indexes of potassium,calcium and phosphorus between the two groups(P>0.05).Conclusion(1)Naoxintong Capsule can effectively improve the glomerular filtration rate and play a protective role in the renal function of DKD patients.(2)Naoxintong Capsule can effectively delay patients’ entry into end-stage renal disease,kidney replacement therapy and even kidney death,and also delay the occurrence of major cardiovascular adverse events,which can greatly reduce the medical burden of patients.(3)Naoxintong Capsule can improve the stage of CKD in DKD patients,especially in the early stage of DKD,showing obvious clinical benefits.(4)Naoxintong Capsule can reduce the index of low density lipoprotein and total cholesterol,and has the effect of regulating lipid.(5)Naoxintong Capsule is safe and effective in the treatment of DKD,and meets the needs of clinical application.