| Objective :(1)To investigate the clinical efficacy of Qizhu Capsules on the microinflammatory state of patients in CKD stage 4(type of insufficiency of spleen and kidney and interweavement of dampness and stagnation of blood).(2)To explore the effect of Qizhu Capsules on Th17/Treg balance of CKD stage 4(type of insufficiency of spleen and kidney and interweavement of dampness and stagnation of blood),as well as the possible mechanism of action.Methods:(1)Select 84 patients with CKD stage 4 that meet the requirements,and divide them into 2 groups according to the random number table method,one group is the basic treatment group and the other is the Qishu capsule group.The patients in basic treatment group were given basic and symptomatic treatment;The Qizhu Capsule group was treated with Qizhu Capsules on the basis of the regimen of the basic treatment group,orally,0.25 g,4 capsules,2 times a day.Both groups had the course of 12 weeks.Before and after treatment,renal function indexes(Scr,BUN,e GFR),microinflammatory indexes(hs-CRP,IL-6,TNF-α),Hb,Alb,lipid indexes(TG,TC,LDLC,HDL-C),TCM syndrome score changes,as well as peripheral blood Th17 cells,Treg cells,Th17/Treg immune indexes of both groups in CKD stage 4(type of insufficiency of spleen and kidney and interweavement of dampness and stagnation of blood)were observed,and the changes and differences of these indexes mentioned above were compared.(2)The general information,symptom scores,microinflammatory and immune indexes of all subjects were recorded in detail.(3)SPSS23.0 software was adopted for data statistical analysis.Results:(1)There was no significant difference in general conditions,TCM syndrome scores,and related laboratory indicators between the Qianqizhu Capsule group and the basic treatment group,and laboratory indexes related during the same period before treatment(P>0.05).(2)After treatment,the values of Scr and BUN in the Qizhu capsule group decreased(P <0.01),while the basic treatment group had no significant change(P>0.05);Qizhu Capsules group had increased e GFR values(P<0.01),while the basic treatment group had no significant change(P>0.05);Scr,BUN,and e GFR between the 2 groups were statistically significant(P<0.05),indicating that Qizhu Capsules could effectively improve the renal function of patients in CKD stage 4,and better than the normal treatment group.(3)After treatment,Qizhu capsules group had decreased the levels of hs-CRP,TNF-α and IL-6.the basic treatment group had no significant change in hs-CRP(P>0.05),and decreased IL-6 and TNF-α(P<0.01);hs-CRP,IL-6,and TNF-α between the 2 groups were statistically significant(P<0.05),indicating that Qizhu Capsules could effectively improve the microinflammatory state of patients in CKD stage 4,with the significantly better than that of the basic group.(4)After treatment,both groups had increased Hb(P<0.05),but there was no significant difference in Hb levels between the groups(P>0.05).After treatment,the ALB level in the Qizhu capsule group increased(P<0.01),and the ALB level in the basic treatment group did not change much(P>0.05);after treatment,the ALB level between the two groups was different(P<0.05).It is proved that Qizhu Capsule has the same effect as the basic treatment group in improving Hb;at the same time,Qizhu Capsule is effective in improving the ALB level of patients with CKD stage 4.(5)After treatment,both groups were significantly reduced(P<0.01),and there was statistical significance in TC and LDL-C(P <0.01);both groups had decreased TG(P<0.01),and there was no significance in TG between 2 groups(P>0.05);both groups had increased HDLC(P<0.01),there was no statistical significance in HDL-C between 2 groups after treatment(P>0.05),indicating that both groups had improved TC and LDL-C in CKD stage 4,and the efficacy of Qizhu Capsules was better than that of the basic treatment,and Qizhu Capsules had the similar efficacy as basic treatment in improving TG and HDL-C.(6)After treatment,Qizhu capsules group had decreased peripheral blood Th17 and Th17/Treg levels(P<0.01),while the basic treatment group had no significant changes(P>0.05),with the Th17 and Th17/Treg levels between the 2 groups statistically significant(P<0.01);both groups had no significant changes in peripheral blood Treg levels(P>0.05),and there was no statistically significant Treg level between the 2groups(P>0.05),indicating that Qizhu Capsules could effectively improve the Th17 and Th17/Treg of patients in CKD stage 4,and there was no obvious efficacy on the improvement of Treg in both groups.(7)After treatment,the TCM clinical syndrome scores of the two groups of patients were reduced(P<0.05),while the Qizhu capsule group and the basic treatment group decreased more(P<0.05).Therefore,the clinical symptoms of the two groups of CKD stage 4 patients have improved after treatment.and Qizhu Capsules were better than basic treatment in improving the clinical symptoms of CKD4.(8)After treatment,both groups had the single TCM symptom score lower than that before treatment(P < 0.01);Qizhu capsules can improve waist and knee soreness,shortness of breath,poor appetite,poor appetite,abdominal distension,unsolid stool,more and frequent nocturia,sticky mouth(P < 0.05)compared with the basic treatment group,while both groups had similar efficacy in improving fatigue,low back pain,and scaly dry skin(P>0.05).(9)After treatment,Qizhu capsules group had the TCM syndrome efficacy of 86.49%,and the basic treatment group had of 61.54%(P<0.05).(10)Before and after treatment,both groups had no abnormality in blood routine and liver function(P>0.05).Conclusion: In this study,Qizhu Capsules were used to treat patients in CKD stage 4(type of insufficiency of spleen and kidney and interweavement of dampness and stagnation of blood),and observations were made on the indexes of micro-inflammation and renal function,blood lipids,hemoglobin,albumin,TCM syndrome scores,Th17/Treg and other indicators.After analysis,the following conclusions were made:1.Qizhu Capsules can improve the clinical symptoms and improve the efficacy of patients in CKD stage 4(type of insufficiency of spleen and kidney and interweavement of dampness and stagnation of blood).2.Qizhu Capsules can reduce the serum hs-CRP,IL-6,and TNF-α of patients in CKD stage 4(type of insufficiency of spleen and kidney and interweavement of dampness and stagnation of blood),and improve the microinflammatory state.3.Qizhu Capsules can improve renal function,blood lipids,anemia and indicators of patients with CKD stage 4(type of insufficiency of spleen and kidney and interweavement of dampness and stagnation of blood),and delay the progression of CKD.4.Qizhu Capsules may improve Th17/Treg immune balance by reducing Th17 cells in peripheral blood,thereby affecting the CKD progression. |