Low-dose tacrolimus combined with tripterygium in treatment of steroid-resistant nephrotic syndrome: a prospective randomized controlled trial

Abstract

Objective To observe the clinical efficacy and safety of low-dose tacrolimus(TAC) combined with tripterygium(TW) in treatment of steroid-resistant nephrotic syndrome(SRNS).Methods The patients,who were diagnosed with mesangial proliferative glomerulonephritis(MesPGN) and focal segmental glomerulosclerosis(FSGS) by biopsy and failed to respond to a 3 month treatment with prednisone(1 mg/,maximum 60 mg/d,were randomly divided into 2 groups(TAC+TW group and TW group).Initially TAC+TW group took TAC 0.05 mg/(kg·d) 2 h after meal at a 12 h interval;the plasma TAC level was examined after 3 days and was kept at 1.5-4 ng/ml;meanwhile,TW was given at 60 mg/d before meal.TW group only took TW(60 mg/d before meal).The efficacy,adverse reactions and plasma TAC levels were observed in each group.Results(1) Totally 20 patients met the recruitment criteria, including 11 in the TAC+TW group and 9 in the TW group.The age,sex,time of onset,blood pressure,24 h urine protein,serum albumin,creatinine,cholesterol,triglyceride,fasting blood glucose,renal pathology types and period of prednisone use were similar between the two groups.(2) In TAC+TW group the urine protein began to decrease one month later;12 months later,8 cases had complete remission(72.7%),2 had partial remission(18.2%),and 1 was ineffective(9.1%),with a total effective rate of 90.9%.In TW group the urine protein also began to decrease one month later;12 months later only 2 cases had complete remission(22.2%),4 had partial remission(44.5%),and 3 were ineffective(33.3%),with a total effective rate of 66.7%.(3)In TAC + TW group the plasma protein was significantly higher than that before treatment;the plasma protein recovered to normal level after 6 month treatment.However,there was no significant increase in TW group.The pre-and post-treatment serum creatinine levels were similar between the two groups.(4) The incidence rates of adverse reactions were not significantly different between the two groups.Conclusion Low dose TAC combined with TW can effectively decrease proteinuria in patients with SRNS,generating a higher rate of clinical remission;meanwhile,the patients have a good tolerance and less adverse reactions.