The Effects Of Treatment By Shenlixin Particles On The Spleen Deficiency And Dampness And Blood Stasis Patients With Chronic Kidney Disease At Stage 4

Objective To investigate the therapeutic efficacy of Shenlixin particles by analyzing laboratory results and clinical symptom in patients with the chronic kidney disease at stage 4 and spleen deficiency and dampness and blood stasis.Methods From April 2014 to April 2016, a randomized, placebocontrolled trial was conducted to test the efficacy and safety of Shenlixin particles in patients with the chronic kidney disease at stage 4 and spleen deficiency and dampness and blood stasis. 30 patients with CKD stage 4 of spleen deficiency and dampness and blood stasis were recruited. After screening visit, enrolled participants were randomly assigned to a treatment group and control group. All participants received western medicine treatment and were given either Shenlixin particles or placebo. During 9-months follow-up, the efficacy and safety of the data were investigated, which included: 1) some indexes of therapeutic efficacy, defined as Blood Urea Nitrogen(BUN),Serum Creatinine(SCr),glomerular filtration rate(GFR),hemoglobin(Hb),parathyroid hormone(i PTH),24 hours urinary protein and change of TCM symptom score.2) safety indicators such as blood, urine,liver function,electrolytes and ECG. At end of trial, the clinical effects and security were assessed.Results(1) After the observation, the increased magnitude of creatinine decreased in the treatment group compared with the control group,with a significant difference between them(P<0.05),and the number of people who enter endpoint events also decreased in the treatment group(3 vs 7),which shows that the treatment group is better than the control group in delaying the elevated serum creatinine;the differences of urea nitrogen and GFR are all insignificant between the two groups(P>0.05);(2)There is no significant difference on liver function(ALT,AST)?serum K+ and TCO2 between the two groups(P>0.05), which suggests that the security of the two groups is better;(3)Compared with the control group,the TCM symptom score in the treatment group has a previous decline,and the difference is statistically significant(P<0.05),which shows that the treatment group is better in improving the TCM symptom score;(4)On TCM syndrome efficiency,total effective rate of the treatment group is 72,7% while in control group is 22.2%,with a significant difference between the two groups(P<0.05),which indicates that the treatment group is better than the control group in improving TCM syndrome.Conclusion Shenlixin particles can reduce the clinical symptom points, improve TCM syndrome of CKD 4 stage by delaying the increase of serum creatinine and improve the quality of life of patients, and has a better safety.