| Objective: To observe the clinical efficacy and safety of Wenshen Xiezhuo Granule in the treatment of chronic kidney disease 3-4,in order to provide a basis for further development of new Chinese medicine.Methods: In this study,a randomized,double-blind,placebo-controlled method was used to enroll 72 patients who met the enrollment criteria of the study.They were grouped according to the random number comparison table,36 patients in each group,divided into treatment group and placebo group.The treatment group was based on the combination of Wenshen Xiezhuo Granules and the control group as the base treatment combined with Wenshen Xiezhuo Granules placebo.The treatment cycle was 12 weeks.The patients were monitored for BUN,Scr,UA,K+,24 h urine protein quantitation,ALB,HB,ALT and safety indicators ECG,urine feces routine,heart rate,respiration,blood pressure,etc.,and recorded and statistical analysis.Results:1.A total of 72 subjects were treated in this trial.During the treatment,2 patients in the control group were lost to follow-up.In the end,70 valid clinical cases were included in the statistical analysis.The baseline of the two groups before treatment was P>0.05,no statistical difference.2.Clinical efficacy evaluation of Chinese medicine:(1)Clinical symptoms of Chinese medicine:After 12 weeks of treatment,the total effective rate was 97.2% in the treatment group and 53% in the placebo group.There was a statistically significant difference between the two groups(P<0.05).(2)Comparison of Chinese medicine points:There was a statistically significant difference between the two groups at 8weeks and 12 weeks after treatment.After 12 weeks of treatment,P<0.05 was compared between the two groups.There were statistical differences between the two groups.3.3.Western medicine clinical efficacy evaluation:According to the western medical efficacy evaluation standard,the 24-hour urine protein quantitative decrease is ?25%,the base value of creatinine increase <25% or the base value of e GFR decrease<25% is effective.After 12 weeks of treatment,the total effective rate was 97.22% in the treatment group and 79.41% in the placebo group.There was a statistical difference between the groups(P<0.05).BUN was compared between the treatmentgroup and the placebo group at 4 weeks,8 weeks,and 12 weeks.There was no significant difference between the two groups.After 12 weeks of treatment,the two groups were compared before and after P>0.05,no statistics difference;After 12 weeks of treatment,there was a statistically significant difference between the treatment group and the placebo group(P<0.05).Before and after treatment,the two groups were compared with P>0.05,no statistical difference;There was no significant difference in Scr between the treatment group and the placebo group at 4 weeks after treatment.There was no significant difference between the treatment group and the placebo group at 8 weeks and 12 weeks.There was significant difference between the treatment group and the placebo group.Weekly treatment,P<0.05 in the treatment group before and after treatment,there was statistical difference,P>0.05 in the placebo group,no statistical difference;There was a significant difference in e GFR between the treatment group and the placebo group at 4 weeks,8 weeks,and 12 weeks.There was a statistical difference between the treatment group and the treatment group before and after treatment(P<0.05).Comparison within the group,P>0.05,no statistical difference;After 12 weeks of treatment,the P <0.05 between the treatment group and the placebo group was statistically different.Before and after treatment,the treatment group was compared with P<0.05,which was statistically different.The placebo group was compared with P.>0.05,no statistical difference;After treatment for 12 weeks,there was a significant difference between the treatment group and the placebo group(P<0.05).There was a statistical difference between the treatment group and the treatment group.P<0.05 was compared between the treatment group and the placebo group.>0.05,no statistical difference.4.Safety index evaluationAfter 12 weeks of treatment,K+ and ALT were all P>0.05 in the group before and after treatment,and there was no statistical difference.There were no obvious abnormalities in electrocardiogram,urine routine,fecal routine,heart rate,respiration,and blood pressure.Conclusion:1.Wenshen Xiezhuo Granule combined with basic treatment can improve the clinical discomfort of patients with stage 3-4 of chronic kidney disease.2.Wenshen Xiezhuo Granule combined with basic treatment can reduce proteinuria,increase hemoglobin and albumin concentration,and improve the nutritional status of patients.3.Wenshen Xiezhuo Granule combined with basic treatment can delay the rise of creatinine and the decrease of glomerular filtration rate,and effectively delay the progression of chronic kidney disease to uremia.4.Wenshen Xiazhuo Granules have good safety. |
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