| Purpose:To observe the clinical effect of Jianpi Bushen ointment on spleen and kidney Qi deficient syndrome of QI deficiency in CKD1-3 and its influence on five immune items(IgA,IgM,IgG,C3,C4),and further confirms whether the ointment has better clinical effect in treating CKD 1-3,whether it can better control the progress of CKD 1-3.Methods:Bottom on the random number table method,those who met including and excluding criteria’s 72 CKD1-3 patients could be separated into the control group(n=36)and the experimental group(n=36),they will be therapied for eight weeks.Ultimately,to observe and analyze the data statistics which the two groups’ after-therapy,including Qi deficiency physical transformation points,TCM syndrome integral,Scr,Blood urea,eGFR,Hb,RBC and the change of immune five(IgA、IgG、IgM、C3、C4).Results1.Baseline data:About gender,age,CKD stage,pre-treatment’s TCM syndrome score,Qi deficiency physical transformation score,Scr,blood urea,eGFR,Hb,RBC,five items of immunity(IgA,IgG,IgM,C3,C4),and safety indicators(ALT,AST,WBC,PLT)were no statistical difference between the two groups.The pre-treatment baseline of all indicators was uniform and comparable.2.Western medicine effect(1)Gross curative effect:Post-treatment,two groups both can ameliorate the clinical symptoms of patients in varying dimension,their global effective rate of 81.8%(experimental group)and 69.7%(control group),and the statistical results are discriminately(P<0.05);(2)Scr,blood urea,eGFR,Hb and RBC of the two groups were ameliorated after 8 weeks of treatment,with statistical difference(P<0.05);(3)Immune five items:Two groups’ IgA,IgG and C3 uplifted conspicuously(P<0.05)after-treatment;Whereas,IgM and C4 of the two groups ameliorated after-therapy,but no statistical difference(P>0.05);3.Therapeutic effect of TCM(1)Therapeutic effect of TCM syndromes:Post-therapy the experimental group and the control group gross effective rate of TCM syndromes were 78.8%,69.7%,and they are with statistical difference(P<0.05);(2)Single symptom score:Post-treatment,not only two groups’ gross TCM syndrome scores,but also the single symptom score of the four principal symptoms ameliorated and had statistical difference(P<0.05);Although three secondary symptoms’(fullness of stomachache,lack of thirst,and loose stool)single symptom score was lower than pretreatment,nevertheless,they had no statistical difference(P>0.05);(3)Qi-deficiency physical transformation score:Two groups’ Qi-deficiency physical transformation score improved after 8 weeks of treatment,and had statistical difference(P<0.05).4.Safety indexDuring the treatment,the safety indicators of all enrolled cases were in the normal range and no obvious abnormality was found,there were no statistical difference(P>0.05).ConclusionUnder the direction of the ideology of "body differentiation,disease differentiation and syndrome differentiation",Jianpi Bushen Ointment has played good clinical effects in the treatment of CKD1-3 patients,as follows:(1)It can efficaciously reduce the Scr and blood urea of CKD1-3 patients and ameliorate their eGFR,Hb and RBC,improve anemia and renal function;(2)It can ameliorate the degree of IgA,IgG and C3 in patients with CKD1-3,and ameliorate the immune function of patients with CKD1-3 to a certain level;(3)It can efficaciously ameliorate their physique of qi deficiency,ameliorate the clinical symptoms of spleen and kidney qi deficient syndrome such as low back pain and food intake,take regulate of the state of CKD1-3;(4)No adverse reactions were found during the treatment,which was secure and available. |