| Background:IgA nephropathy is currently the most common primary glomerulonephritis in the world.The disease has been considered to be benign progress in the past,but with the continuous deepening of clinical research in recent years,it is now clear that a considerable number of patients have a progressive disease course.According to a large number of data reports,about 50% of patients with IgA nephropathy will develop into end-stage renal disease within 25-30 years after illness.At present,for the treatment of patients with IgA nephropathy,the role of renin-angiotensin system blockers has been widely recognized,but whether to use drugs in combination with immunosuppressive therapy is still controversial.there is still a lack of research evidence on traditional Chinese medicine for IgA nephropathy.As a traditional Chinese medicine,Tripterygium wilfordii have strong anti-inflammatory and immune regulation effects.It has been widely used in rheumatoid arthritis,systemic lupus erythematosus and other autoimmune diseases.In recent years,it has gradually been used in the field of kidney disease,such as the treatment of IgA nephropathy.Studies have confirmed that Tripterygium wilfordii can effectively reduce IgA nephropathy's 24-hour urinary protein,delay glomerular sclerosis damage,and improve clinical remission rate.It was better than treating IgA nephropathy with ACEI/ARB alone,but there are also adverse reactions such as decreased white blood cells,impaired liver function,and menstrual disorders.With the development of modern pharmaceutical technology,more efficient and low-toxic Tripterygium drugs have begun to be used in clinical.Kunxian capsule,as a traditional Chinese medicine of Tripterygium wilfordii,is composed of Tripterygium Hypoglaucum Hutch,Epimedium,Wolfberry fruit and Cuscutae Semen.In theory,it can combat the reproductive toxicity of Tripterygium Hypoglaucum Hutch,but does not affect its anti-inflammatory and immunosuppressive effects.At present,Kunxian capsule is definitely effective in the treatment of rheumatoid arthritis and lupus nephritis.However,at present,Kunxian capsule has not been reported in the treatment of IgA nephropathy,and there is no evidence of randomized controlled trials.The efficacy and adverse reactions need to be confirmed.objective:A prospective,randomized,controlled study was conducted to evaluate the clinical efficacy and safety of Kunxian capsules in the treatment of IgA nephropathy.Materials and Methods:In this study,a prospective,randomized,and controlled method was used.Patients diagnosed with IgA nephropathy who were diagnosed with renal puncture biopsy at the Department of Nephrology in the First Affiliated Hospital of Chengdu Medical College from November 2018 to December 2019 were included in the study.A total of 39 patients were reported,randomly divided into 20 cases of Kunxian capsule group and 19 cases of leflunomide group,All patients were given the RAS blockers Losartan Potassium 50 mg po qd and dipyridamole 50 mg po tid.Besides treatment mentionde above,Kunxian capsule group was given Kunxian capsule 0.6g po tid,and leflunomide control group was given leflunomide 20 mg po qd.The observation period was 12 weeks,before treatment and the 4th,8th,and 12 th week after treatment after treatment review the 24-hour urine protein quantification,white blood cells,hemoglobin,platelets,serum creatinine,urea nitrogen,alanine aminotransferase,aspartate aminotransferase and record clinical adverse reactions.Result:1.Clinical efficacy: in the Kunxian capsule group,there were 16 cases of complete remission,2 cases of partial remission,and 2 cases of no remission,with the total effective rate of 90%;in the leflunomide group,11 cases of complete remission,4 cases of partial remission,3 cases of no remission,and 1 case of discontinue,with the total effective rate of 83.3%.The total effective rate of treatment in the Kunxian capsule group was higher than that in the leflunomide group(P>0.05);2.Laboratory index:(1)Compared with before treatment,the 24-hour urine protein in the Kunxian capsule group and the leflunomide group were significantly reduced after 4th,8th,and 12 th week of treatment(P<0.05).There was no significant difference in 24-hour urine protein between the two groups before and 12 th week after treatment(P>0.05);(2)Compared with before treatment,there was no difference in serum albumin between Kunxian capsule group and leflunomide group at 4th,8th,and 12 th week after treatment(P>0.05).Before treatment,there was no difference in serum albumin between the two groups(P>0.05).At the 4th,8th,and 12 th week after treatment,there was difference in serum albumin between the two groups(P<0.05);(3)Compared with before treatment,the serum creatinine in the Kunxian capsule group and the leflunomide group decreased after 12 th week of treatment(P>0.05).There was no difference in serum creatinine between the two groups before and 12 th week after treatment(P>0.05).Compared with before treatment,the urea nitrogen decreased in the Kunxian capsule treatment group and the leflunomide control group at the 4th,8th and 12 th week after treatment(P>0.05).There was no difference in urea nitrogen between the two groups before and 12 th week after treatment(P>0.05);3.Safety indicators: Before treatment,there was no difference in white blood cells,hemoglobin,and platelets between the two groups(P>0.05).At 12 th week after treatment,there was also no difference between the two groups(P>0.05).Compared with before treatment,there were no changes in white blood cells,hemoglobin,and platelets in the two groups at 4,8,and 12 weeks after treatment.(P>0.05).Before treatment,there was no difference between the ALT and AST in the two groups of patients.(P>0.05).At 12 th week after treatment,there was also no difference between the two groups(P>0.05).Compared with before treatment,the ALT and AST increased in the two groups at 4th,8th,and 12 th week after treatment(P>0.05);4.Adverse reactions: In the Kunxian capsule treatment group,3 patients had adverse reactions,including 1 irregular menstruation and 2 gastrointestinal reactions,the incidence of adverse reactions was 15%.A total of 4 cases of adverse reactions occurred in the leflunomide control group,including 2 cases of impaired liver function and 2 cases of gastrointestinal reactions,the incidence of adverse reactions was 21.1%(P>0.05).Conclusion:1.Kunxian capsule can reduce urinary protein in patients with IgA nephropathy,with quick and stable effect,which is consistent with the treatment effect of leflunomide;2.Kunxian capsules can stabilize creatinine and urea nitrogen levels and delay the progression of chronic kidney disease in patients with IgA nephropathy;3.Kunxian capsule can reduce urine protein in patients with IgA nephropathy,but it has no obvious effect on serum albumin in a short time;4.Kunxian capsule and leflunomide have similar incidence of adverse reactions.Kunxian capsule has no obvious hepatotoxicity,gastrointestinal reaction is mild,it can be improved by adjusting the medication time. |
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