Kunxian Capsule In Treating Proteinuria In IgA Nephropathy(the Type Of Spleen And Kidney Yang Deficiency):a Randomized Controlled Clinical Trial

Objective: To observe the efficacy of Kunxian Capsule on proteinuria in IgA nephropathy(spleen and kidney yang deficiency type).Methods:A prospective,single-center,randomized controlled trial design was adopted.46 patients with IgAN(the type of Spleen and Kidney Yang Deficiency)were randomly divided into trial group(23 cases)and control group(23 cases)for 8 weeks.The experimental group was treated with Kunxian capsule combined with prednisone acetate tablets(referred to as "Kunxian capsule group"),The control group was treated with prednisone acetate tablets(referred to as " Glucocorticoid group ").The 24-hour urinary protein,transaminase,leucocyte count,blood creatinine and other laboratory indexes and TCM main-syndrome scores were recorded and compared,and the therapeutic effectiveness was observed.Results:1.General information of research objects:There is no difference in general information data.2.(1)Main observation indicators :The 24-hour urinary protein: after treatment,there was a significant difference between Kunxian capsule group and Glucocorticoid group before and after treatment(P<0.05).After treatment,there was no significant difference in urine protein quantification between the two groups(P>0.05).Plasma albumin: Before and after treatment,Kunxian group and Glucocorticoid group with no statistical difference(P > 0.05).(2)Secondary observation index:1)TCM main syndrome score:There were statistical differences in Kunxian capsule group before and after treatment(P<0.05).In Glucocorticoid group,only abdominal distension,leuko complexion and fatigue were statistically different before and after treatment(P<0.05).2)Total score: The therapeutic quality of Kunshan group was different from that of Glucocorticoid group(P >0.05).3.Efficacy:(1)Western medicine efficacy:Kunxian group was 73.9%,Glucocorticoid group was 53.2%(P > 0.05)(2)The total effective rate of curative effect of syndrome:Kunxian group was 78.26%,Glucocorticoid group was 13.04%(P <0.05).4.Safety index and Untoward reaction:(1)After 8 weeks of observation,there was no difference in Safety index between the two groups before and after treatment(P >0.05).(2)Nausea occurred in 2 cases in Kunxian group,and the discomfort was relieved after adjusting capsule to take with meals.Acne occurred in 2 patients in both groups in recent 8 weeks,which was related to Glucocorticoid application.There were 2 cases in Kunxian group and 3 cases in Glucocorticoid group appeared dizziness,and the symptoms were relieved by adjusting antihypertensive drugs.Conclusion:.(1)Kunxian group and Glucocorticoid have improved TCM syndromes of IgAN(spleen and kidney yang deficiency type).Kunxian combined with Glucocorticoid has curative effect on improving TCM main syndromes of patients.(2)Kunxian capsule combined with prednisone acetate can reduce urine protein in IgAN(spleen and kidney yang deficiency type).(3)There was no difference in reducing proteinuria between the two groups within 8 weeks.(4)Within 8 weeks,the two groups had no effect on safety indicators.(5)Both groups can cause dizziness and acne,and Kunxian group still has nausea,which can be alleviated by adjusting medication.