| Objective:Observe the efficacy of Suyin Jiedu Granules intervening in CKD3-4 stage,kidney deficiency and damp turbidity,improving glomerular filtration rate,and providing objective clinical research evidence for the wide application of the drug.Method:This study adopts a randomized,controlled trial design.Patients with CKD 3-4 stage and kidney deficiency and damp turbidity who meet the inclusion criteria were randomly divided into groups.The experimental group was given basic treatment+Suyin Jiedu granules,and the control group was given basic treatment.Both groups were treated for 12 weeks.Record the TCM syndrome scores,blood creatinine,glomerular filtration rate(calculated by CKD-EPI2009 SCR formula),urea nitrogen,and uric acid of the two groups before treatment,4 weeks after treatment,8 weeks after treatment,and 12 weeks after treatment,Liver function(AST/ALT,yGT,TB,ALP),blood routine(WBC),blood potassium,and possible adverse reactions after taking the medicine,analyze the data and evaluate the clinical value of Suyin Jiedu Granules.Results:Before treatment in the test group,blood creatinine(164.85±58.99umol/L),urea nitrogen(10.65±4.16mmol/L),uric acid(431.87±93.24umol/L),and glomerular filtration rate(43.57±13.37ml/min/1.73m2),TCM syndrome score(10.00±4.07),before treatment in the control group,blood creatinine(160.08±41.28μmol/L),urea nitrogen(9.36±3.22mmol/L),uric acid(436.89±104.35μmol/L),Glomerular filtration rate(40.03±10.55ml/min/1.73m2),TCM syndrome score(10.17±4.38),there was no statistical difference between the two groups(P>0.05),There was no statistical difference in blood pressure between the two groups before treatment(P>0.05).For subdividing the changes of eGFR at different time points,there is an interaction between time and group.The changing trend of eGFR conversion time changes significantly.During the treatment process at 4 weeks,8 weeks,and 12 weeks,the experimental group is more Slightly higher than the eGFR level,it can improve the glomerular filtration rate of patients with chronic kidney disease,and the eGFR level transfer time change in the test group has been improving,from week 0(43.57±13.37ml/min/1.73m2)At 4 weeks(52.19±20.59ml/min/1.73m2),at 8 weeks(56.59±24.86ml/min/1.73m2),and at 12 weeks(59.27±26.83ml/min/1.73m2).There was no significant difference between each time point,and the eGFR level did not change significantly,at week 0(40.03±10.55ml/min/1.73m2),at week 4(41.74±11.68ml/min/1.73m2),at week 8(43.72±11.80ml/min/1.73m2),at 12 weeks(43.46±11.94ml/min/1.73m2).For the changes in SCR at different time points in the two groups,there was no interaction between time and group.The two groups’ SCR fluctuated in the same trend over time.The main effect of group on SCR was not statistically significant,P=0.825(P>0.05),The main effect of time point on SCR is statistically significant,P<0.001,SCR in the two groups gradually decreases with time,the difference between 0 and 4 weeks is statistically significant(P<0.001),4 weeks and 8 weeks It was statistically significant at time(P=0.02),and there was no statistical significance at 8 weeks and 12 weeks(P=1.00>0.05).SCR decreased smoothly in the two groups from 8 weeks after treatment to 12 weeks after treatment.For the changes in BUN at different time points in the two groups,there is an interaction between time and group.The BUN fluctuating trend of the two groups over time is significantly inconsistent.The BUN of the experimental group was compared with the control at 4 weeks after treatment,8 weeks after treatment,and 12 weeks after treatment.There was no statistical difference in BUN between the two groups(P=0.51,P=0.62,P=0.26),but the difference between 0 and 4 weeks in the experimental group was statistically significant(P=0.007<0.05),4 weeks(9.29±5.19mmol/L)and 8 weeks(9.20±4.06mmol/L)were not statistically significant(P=1.00),8 weeks and 12 weeks(8.93±4.93mmol/L)were not statistically significant(P=1.00),BUN level improved 4 weeks after treatment compared with before treatment,but no improvement after treatment.In the control group,the time factor had no statistically significant effect on BUN alone(P=0.319>0.05),and BUN did not improve over time.From the numerical point of view,it has increased,from 0 weeks(9.36±3.22mmol/L)to 12 weeks(10.07±3.60mmol/L).For the changes in UA at different time points in the two groups,there is no interaction between time and group.The UA fluctuates in the two groups with the same trend over time.The main effect of the group on UA is not statistically significant,P=0.825(P>0.05),The main effect of time point on UA was statistically significant,P<0.001,both groups of UA gradually decreased over time,the difference between 0 and 4 weeks was statistically significant(P=0.04),4 weeks and 8 weeks There was no statistical significance at time(P=1.00),and no statistical significance at weeks 8 and 12(P=1.00>0.05).The UA of the two groups decreased at 4 weeks after treatment compared with before treatment,but there was no significant improvement afterwards.For the changes in TCM syndrome scores of the two groups at different time points,there is an interaction between time and group.The two groups’ scores fluctuate significantly over time.There is a statistical difference between the test group and the control group 4 weeks after treatment(P=0.02),the test group was better than the control group in improving TCM syndrome scores.There was no statistical difference between the test group and the control group at 8 weeks after treatment(P=0.08),and there was no statistical difference between the test group and the control group at 12 weeks after treatment(P=0.16)).In the experimental group,the TCM syndrome integral level has been improving over time,from 0 week(10.00±4.07)to 4 weeks(6.39±2.67),8 weeks(5.47±2.26),12 weeks(4.50±2.40).In the control group,the TCM syndrome integral level has been improving over time,from 0 weeks(10.17±4.38)to 4 weeks(8.11±3.70),8 weeks(6.58±3.02),at 12 weeks(5.39±3.01).In terms of the efficacy of traditional Chinese medicine,the effective rate of the experimental group was 97.37%,while the effective rate of the control group was 77.78%.There was a significant difference between the two groups(P=0.009),indicating that the Suyin Jiedu Granules had better clinical symptoms than the control group after intervention.Good relief will improve the quality of life more significantly.In terms of the overall efficacy of the disease,the total effective rate of the experimental group is 97.37%,and the total effective rate of the control group is 77.78%.There is a significant difference between the two groups(P=0.01),indicating that the total clinical effective rate of Suyin Jiedu Granules+basic treatment is better than that of basic therapy.Basic treatment.In terms of adverse reactions and drug side effects,there was 1 case of elevated liver enzymes in the test group,only a slight increase in AST,and 2 cases of serum potassium higher than normal.This may be related to the patient’s decreased renal function and electrolyte imbalance.The control group appeared Serum potassium was higher than normal in 2 cases,the total number of adverse reactions was not significantly abnormal(P=0.361),and there were no serious adverse reactions in both groups.Conclusion:Suyin Jiedu Granules combined with basic treatment can effectively increase the glomerular filtration rate of chronic kidney disease stage 3-4(kidney deficiency and damp turbidity),improve the patient’s clinical symptoms,and have a better curative effect than basic treatment. |
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