| Objective: To observe the changes of IL-6,sIL-6R,p-JAK2,p-STAT3 and FN levels in non-dialysis chronic kidney disease(CKD)stage 3-5 patients with damp-heat syndrome between pre-therapy and post-therapy,and to investigate whether qingshen granule can improve renal function and delay renal fibrosis by inhibiting the activation of IL-6/JAK2/STAT3 signal pathway,so as to provide more clinical basis for its treatment of CKD.Methods: Sixty-eight outpatients or inpatients with CKD stage 3-5 damp-heat syndrome were chosen and split into two groups according to the random number table(34 cases in treatment group and control group respectively),and 20 cases were added as the normal group.Because two patients in the treatment group stopped taking Qingshen granules,one patient added Bailing capsule,and one patient in the control group could not tolerate retention enema,a total of 4 subjects were excluded during the trial and 64 were ultimately completed(31 in the treatment group and 33 in the control group).Patients in both groups were treated with basic Western medicine and retention enema,and Qingshen granules were added to the treatment group,its usage is 10 g once,three times a day,and the total course of treatment was 12 weeks.Serum creatinine(Scr),estimated glomerular filtration rate(eGFR),scores of TCM syndromes,levels of IL-6,sIL-6R,p-JAK2,p-STAT3 and FN were measured before and after treatment,were compared to evaluate the clinical efficacy of the two groups.Results:(1)Clinical efficacy: The total effective rate of the treatment group was higher than that of the control group(P<0.05),the former was 87.1%,the latter was 72.7%.(2)TCM syndrome curative effect: The total effective rate of the treatment group was higher than that of the control group(P<0.05),the former was 87.1%,the latter was69.7%.(3)TCM syndrome score: Before treatment,there was nonsense in the scores between the two groups of patients(P>0.05).After treatment,the scores of the two groups of patients were obvious lower than those before treatment(all P<0.01),and the decline of TCM syndrome scores in the treatment group was superior to that in the control group(P<0.05).(4)Scr,eGFR: There was no discrepancy in renal function between the two groups of patients before treatment(P>0.05).After treatment,Scr was declined(P<0.01)and eGFR was augmented(P<0.01)in the treatment group,but there was no significant change in the control group(P>0.05).The changes in the treatment group were significantly better than those in the control group(P<0.01).(5)Before treatment,compared with the normal group,the levels of IL-6,sIL-6R and FN in serum and the expression of p-JAK2 and p-STAT3 in peripheral blood cells in the two groups of patients were increased(P<0.01),and there was no difference between the two groups of patients(P>0.05).After treatment,the levels of IL-6,p-JAK2,p-STAT3,FN and sIL-6R in the two groups of patients were significantly lower than those before treatment(all P<0.01),and the reduction degree of IL-6,p-JAK2,p-STAT3,FN and sIL-6R in the treatment group was more severe(P<0.01,P <0.05).(6)Safety analysis: During the course of this trial,no adverse drug reactions occurred after taking Qingshen granule,indicating that the drug has good safety.Conclusion:(1)The levels of IL-6,sIL-6R,FN in serum and p-JAK2,p-STAT3 in peripheral blood cells in patients with damp-heat syndrome of CKD stage 3-5 are increased,and the correlation analysis of IL-6 with p-JAK2 and p-STAT3 suggested that IL-6 was positively correlated with p-JAK2 and p-STAT3,which confirms that the activation of IL-6/JAK2/STAT3 signaling pathway promotes the occurrence and development of CKD.(2)Qingshen granule can reduce renal damage in patients with CKD stage 3-5damp-heat syndrome,improve renal function and clinical manifestations.(3)Qingshen granule can reduce the levels of IL-6,sIL-6R,FN in serum and p-JAK2,p-STAT3 in peripheral blood cells in patients with CKD stage 3-5 damp-heat syndrome,indicating that Qingshen granule can interfere with the activation of IL-6/JAK2/STAT3 signaling pathway,thereby delaying renal fibrosis.(4)During the course of this trial,no adverse drug reactions occurred after taking Qingshen granule,indicating that the drug has good safety. |