Abstract
Objective: To observe the clinical efficacy and safety of low dose tacrolimus (TAC) combined with tripterygium (TW) in treatment of steroid resistant nephritic syndrome (SRNS). Method: 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/kg·d), were randomly divided into 2 groups (TAC + TW Group and TW Group). Initially TAC + TW group took TAC 0.05mg/(kg·d) 2 h after meal at 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). The efficacy, adverse reactions and plasma TAC levels were observed in each group. Results: 1) Totally 20 SRNS patients completed the trial, 11 of TAC + TW Group and 9 of TW Group. There is no statistical difference between the two groups in terms of age, gender, duration since onset of the disease, blood pressure, 24 h UPQ, serum albumin, creatinine, cholesterol, triglyceride, FBG, kidney pathological categories, time of taking prednisone etc.; 2) Urine protein started to decrease after 1 month treatment in both of TAC + TW and TW groups. By the 12th month of treatment, TAC + TW group showed 8 cases of complete remission (72.7%), 2 cases of partial remission (18.2%) and 1 case of no improvement (9.1%), while those of TW groups were 2 (22.2%), 4 (44.5%) and 3 (33.3%), respectively; 3) With treatment, the TAC + TW Group patients’ plasma protein was significantly higher than that of pretreatment stage and recovered to normal level after 6 month of treatment. However, there was no significant plasma protein increase in TW Group. No obvious changes were observed on serum creatinine level of patients of both the two groups; 4) The incidence of adverse reactions was not significantly different between the two groups. Conclusion: TAC + TW reduced proteinuria of SRNS patients, increased clinical remission rate and was tolerant to SRNS patients. We conclude that TAC + TW treatment is an effective way to treat patients with SRNS.
Highlights
As an immune disease, primary nephrotic syndrome is usually treated with adrenocortical hormone and cytotoxic drugs in clinic
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/kg·d), were randomly divided into 2 groups (TAC + TW Group and TW Group)
Therapeutic methods available for steroid-resistant nephrotic syndrome (SRNS) include the application of cyclophosphamide, cyclosporine A, implosive therapy of high-dose methylprednisolone, ACEI or ARB and mycophenolate mofetil, etc
Summary
Primary nephrotic syndrome is usually treated with adrenocortical hormone and cytotoxic drugs in clinic. For patients whose clinical symptoms are not remitted completely or partially after being treated with hormone of standard dosage (1 mg/kg/d) for at least 3 months, they are diagnosed with steroid-resistant nephrotic syndrome (SRNS) [1]. SRNS is usually presented, pathologically, as minimal change disease (MCD), mesangial proliferative glomerulonephritis (MesPGN) and focal segmental glomerulosclerosis (FSGS), with a few of membranous nephropathy and individual of non-IgA mesangial proliferative glomerulonephritis, which is difficult to be treated and generally immunosuppressive agents such as cyclophosphamide and cyclosporine. The treatment objects are hormone resistance and (or) dependent nephrotic syndromes patients mostly attacked FSGS and MCD [6,7]. Based on the previous researches, we observed the effectiveness and safety of treatment of SRNS with small-dose TAC combined with single-dose TW, aiming to explore a cost-affordable method to treat SRNS
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