Objective:To evaluate the clinical effect of the method of dissolving phlegm and dispelling stasis(Watao Yike Powder)in the treatment of polycystic kidney disease(PKD)with interlocking phlegm and stasis by clinical observation.Methods:A randomized controlled trial was designed to screen cases according to the inclusion criteria,and the included patients were randomly divided into control and trial groups.The control group was given basic therapy,and the trial group was treated orally with Watao Yike Powder on top of the basic therapy for 24 weeks.The serum creatinine(Scr),blood urea nitrogen(BUN),retinol-binding protein(RBP),cystatin C(Cys C),serumβ2-microglobulin(β2-MG),estimated glomerular filtration rate(e GFR),urine protein/creatinine ratio(UPCR),urinary blood cell count(URBC),height-adjusted total kidney volume(ht TKV)and TCM syndrome score(TCMSS)were recorded before and after treatment.The results were analyzed and processed using statistical methods to determine the clinical efficacy.Results:This clinical study was finally completed with 63 patients,32 in the control group and 31 in the trial group.There was no statistical differences in Scr,BUN,RBP,Cys C,β2-MG,e GFR,UPCR,URBC,ht TKV and TCMSS between the two groups before treatment(P>0.05),and the two groups were comparable.Scr,BUN,Cys C,β2-MG,URBC,ht TKV,and TCMSS were all higher and e GFR and UPCR were all lower in the control group after treatment than before,and the differences were statistically significant(P<0.05);there was no significant change in RBP than before,and the differences were not statistically significant(P>0.05).After treatment,Scr,BUN,Cys C,UPCR,ht TKV,and TCMSS in the trial group decreased compared with before,and e GFR increased compared with before,and the differences were statistically significant(P<0.05).After treatment,there was no significant change in RBP,β2-MG,URBC in the trial group compared with before,and the difference was not statistically significant(P>0.05).The differences in Scr,BUN,e GFR,ht TKV,and TCMSS between the control and trial groups after treatment were statistically significant(P<0.05),but the differences in RBP,Cys C,β2-MG,UPCR,and URBC were not statistically significant(P>0.05).After treatment,the efficacy rate of Chinese medical efficacy rate in the trial group was 48.39%,which was statistically significant compared with the control group(P<0.01);the total clinical efficacy rate was 51.61%,which was statistically significant compared with the control group(P<0.01).There were no adverse reactions in both group during the treatment.Conclusion:The“Ke Nang”theory-guided treatment of phlegm-stasis interconnection type PKD has the effect of improving renal function,reducing kidney volume,and alleviating patients’TCM symptoms,but no effect of lowering urinary protein and urine red blood cells was found,achieving some clinical efficacy and good safety. |