Treatment Of Glycosides Of Tripterygium Wilfordii Combined With RAS Blockers In CKD Stages 2?3 Of IgA Nephropathy

Background:IgA nephropathy(IgAN)is the most common primary glomerulonephritis in the world,and approximately accounts for 36.7%~58.2% of primary glomerulonephritis in China.The diagnosis of IgAN relies on renal immunopathology.It was believed that the prognosis of IgAN is well in the past,but people found that about half of the patients progressed to the end stage renal disease(ESRD)in recent clinical observation.The pathogenesis is not clear,and there is no specific therapy for IgAN.Renin angiotensin system blockers possesses relatively positive efficacy.It was still controversial to use immunosuppressive drugs alone or in combination,such as corticosteroid,cyclophosphamide and azathioprine.There were less studies and no guide for patients with moderate proteinuria and chronic kidney disease(CKD)stages 2 ~ 3 phases,who with estimated glomerular filtration rate(eGFR)between 30~90mL/(min·1.73m2).Glycosides of Tripterygium wilfordii(GTW)is a kind of Chinese medical immunosuppressive drug,and it showed positive clinical efficacy for nephrotic syndrome,rheumatoid arthritis and diabetic nephropathy previously.But for those patients with CKD(stages 2~3)of IgAN,GTW's efficacy and side-effect still remain to be studied.Objective:To investigate the efficacy and safety of GTW combined with RAS blockers in treatment of CKD stages 2~3 of IgA nephropathy,we conducted a randomly,controlled and prospective trial and corticosteroid combined with RAS blockers were used in the control group.Methods:109 patients were randomized into the observation group(n=55)and the control group(n=54).On the basis of taking RAS blockers(Candesartan cilexetil tablet,4mg 2/d),patients in the observation group received GTW(1mg/kg/d),and patients in the control group received methylprednisolone(0.6mg/kg/d).The treatment course of GTW is six month,and stop drug when proteinuria reaches complete remission.As for control group,after 8 weeks of receiving methylprednisolone,subtract 10%~15% of original dosage every 3~4 weeks,until the dosage reaches 8mg/d,then maintain 2 months to take the dosage 4mg/d.The blood pressure,proteinuria,serum creatinine,liver function,blood routine and other indicators were checked regularly,then proteinuria or serum creatinine which increases more than 50% baseline was used to estimate whether withdrew from the study.The proteinuria,renal function and adverse effect were observed during treatment.Results:There were no significant differences between the two groups' s baseline data(including laboratory data and clinical parameter).The level of the two groups' s proteinuria decreased significantly during the treatment time.At 3,6,9 and 12 months of treatment,proteinuria in the two groups was lower than the baseline(P<0.05).During follow-ups,there was no significant difference of serum creatinine,eGFR between the two groups and baseline(P>0.05).Compared with patients in CKD stage 3,patients in CKD stage 2 had higher remission rate(P<0.05).And if patients of the two groups were in the same stage,there was no significant difference.The total effective rate in the observation group was 70.6% and in the control group was 74.5%,which was no significant difference in the two groups(P>0.05).During follow-ups,there was no significant difference in terms of proteinuria,serum creatinine and eGFR between the two groups.The occurrence rate of adverse effects was 9.8% vs 27.4% and there was significant difference between the two groups(P<0.05).Conclusion:GTW combined with RAS blockers is one of useful therapeutic options for CKD stages 2~3 of IgA nephropathy.It can significantly decrease proteinuria,slow down the progress of CKD,with lower adverse effects and better tolerance to patients.So,GTW can serve as a new candidate drug for the therapy of IgAN.