| BackgroundChronic kidney disease is one of the diseases that seriously threatens human’s health.The total prevalence of CKD in adults in China was 10.8%,which is roughly equivalent to the level in developed countries.Therefore,the factors that lead to the occurrence and development of chronic kidney disease attracted great attention from nephrology researchers,.At present,proteinuria,hypertension,hyperglycemia and hyperlipidemia as risk factor the progression of CKD has become the consensus.Traditional Chinese medicine treatment can effectively delay the step of require renal replacement therapy JianPiYiShenXieZhuo Formula can improve the patient’s kidney function and delay the progression of the renal disease.This study aims to analyze the clinical efficacy of JianPiYiShenXieZhuo Formula in delaying the progression of chronic kidney disease in patients with stage 3-5(non dialysis),laying a solid foundation for further research.ObjectiveThe survival,clinical efficacy and safety of spleen and kidney deficiency in the treatment of chronic kidney disease stage 3-5 with spleen and kidney qi deficiency and turbidity were observed,and its role in delaying chronic kidney disease was preliminarily explored.Methods(1)(1)A retrospective cohort analysis method was used to collect 1936 patients who were hospitalized for the first time at Beijing Traditional Chinese Medicine Hospital affiliated with Capital Medical University from January 1,2019 to December 31,2020.Among them,a total of 174 patients met the inclusion criteria.Through propensity score matching,110 patients were ultimately divided into exposed and non exposed groups in a 1:1 ratio.The exposed group received basic treatment and JianPiYiShenXieZhuo Formula,while the non exposed group received basic treatment only.The observation period is more than one year.(2)Efficacy indicators:①Main indicators:cumulative incidence,median survival time,and risk ratio of endpoint events(renal replacement therapy,CKD progression,death)of patients.② Secondary indicators:blood creatinine(Scr),glomerular filtration rate(eGFR),urea(Urea),blood uric acid(UA),24-hour urine protein quantification(24hUTP),blood albumin(Alb),hemoglobin(Hgb),respectively,before treatment and 12 months of treatment.③ Other indicators:blood calcium(Ca),blood phosphorus(P),carbon dioxide binding capacity(CO2).④ Safety indicators:serum alanine transaminase(ALT),serum aspartate aminotransferase(AST),and serum potassium(K)were tested once before treatment and 12 months after treatment.Results(1)The study selected 110 eligible patients as subjects including 55 in the exposed group and 55 in the non-exposed group.(2)Analysis of main indicators:① Among 110 patients,a total of 56 cases(50.9%)entered the composite endpoint event,including 18 cases(15.6%)in the exposure group and 38 cases(36.5%)in the non exposure group.The median time for the exposure group to enter the endpoint event was 36.0(20.0,36.0)months,and the median time for the non exposure group to enter the endpoint event was 19.0(12.0,27.0)months.Comparing the cumulative survival rates of two groups of patients,the 12 month cumulative survival rate of the exposed group was 89.0%,while the non exposed group was 74.5%;The cumulative survival rate at 24 months in the exposed group was approximately 69.9%,while the cumulative survival rate in the non exposed group was 33.2%;The cumulative survival rate at 36 months in the exposed group was 34.2%,while in the non exposed group it was approximately 13.3%.There is a significant correlation between the Jianpi Yishen Jiezhuo Formula and the reduced risk of endpoint events in patients with chronic kidney disease in stages 3-5 Multivariate Cox regression analysis showed that the incidence of endpoint events in the exposed group was significantly lower than that in the non exposed group(aHR:0.294;95%CI:0.158,0.545;P<0.001),and the risk of entering the composite endpoint event in the exposed group was reduced by 70%compared to the non exposed group.This suggests that taking the Jianpi Yishen Jiezhuo Formula is an independent protective factor for patients entering the composite endpoint event,and the Jianpi Yishen Jiezhuo Formula has the effect of delaying the disease progression of CKD 3-5 non dialysis patients.In addition,the prognosis of patients is mainly affected by the baseline 24hUTP and eGFR.According to the stratified evaluation of the relative risk ratio for the number of follow-up visits,the results showed that when the number of follow-up visits was 1-2 times per year(HR:0.734;95%CI:0.294,1.836;P=0.509),the relative risk ratio was significantly higher than that of patients with 3-6 visits per year(HR:0.317;95%CI:0.103,0.977;P=0.045),and significantly higher than that of patients with 7-12 visits per year(HR:0.118;5%CI:0.035,0.393;P<0.001).The P values were all less than 0.05,and the difference in the risk of CKD progression reduction between the exposed group and the non exposed group was statistically significant.④ Sensitivity analysis suggests that in female patients,age>65 years old,ALB≤35g/L,Hgb>115g/L,CO2CP>22mmol/L,and eGFR>10mL/min/1.73 m2 stratification,the exposed group has a lower incidence of endpoint events compared to the non exposed group.This suggests that in the above classification,the application of Jianpi Yishen Jiezhuo Formula is more conducive to delaying the progression of chronic kidney disease.(3)After 12 months of treatment,serum creatinine increased in both the exposed group and non-exposed group compared with before treatment,and the difference in serum creatinine in the exposed group after treatment increased slowly compared with that in the non-exposed group(P<0.001).The eGFR decreased significantly compared with the pretreatment group,and the eGFR decreased significantly compared with the exposed group in the non-exposed group after treatment(P=0.028).UA decreased after treatment in the exposure group compared with before treatment(P=0.048).Urea increased after treatment in both the exposed group and the non-exposed group(P<0.001),and the growth trend of Urea after treatment in the exposed group was lower than that in the non-exposure group.The 24 hUTP after treatment in the exposed group was lower than before treatment,and the 24 hUTP after treatment in the non-exposure group was higher than before treatment.ALB increased after treatment in the exposed group compared with before treatment(P=0.071),while ALB decreased after treatment in the non-exposure group compared with before treatment.Hgb was higher in the exposed group than before treatment(P=0.041),and Hgb was lower in the non-exposure group after treatment than before treatment.(4)Other indicators and safety analysis:the blood phosphorus increased compared with the pre-treatment(P<0.001)and the carbon dioxide binding capacity decreased(P=0.026)after treatment in the non-exposed group,the difference was statistically significant,but both were within the normal range before and after treatment.There were no significant differences between serum alanine aminotransferase(ALT),serum aspartate aminotransferase(AST),serum potassium(K),and serum calcium(Ca)before and after treatment(P>0.05).Conclusion(1)The formula can delay the progression of renal function in patients with chronic kidney disease in stages 3-5(non dialysis),delay their progression to end-stage kidney disease,and reduce the incidence and risk ratio of endpoint events.Patients with regular follow-up have a lower risk of endpoint events(2)The Jianpi Yishen Jiezhuo Formula can delay the increase of blood creatinine and urea nitrogen,reduce blood uric acid and proteinuria,and increase albumin and hemoglobin. |
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