Objective: To assess the safety and clinical efficacy of leflunomide (LEF) and prednisone on refractory nephrotic syndrome (RNS).
Methods: A total of 52 patients with RNS were treated for 24 weeks between 2010 and 2014 in our hospital. In the treated group, 26 patients were treated with LEF and prednisone, and, in the control group, 26 patients were treated with cyclophosphamide (CTX) and prednisone. During the treatment, 24 h urinary protein excretion and the serum levels of albumin and cholesterol, and kidney function were assayed before and after the therapy. Adverse reactions during treatment were recorded.
Results: In the LEF group, the medication was markedly effective in eight cases and effective in nine cases; the total efficacy rate was 65.30%. In the CTX group, the treatment was markedly effective in six cases and effective in nine cases; the total efficacy rate was 57%. There were no significant differences between the results of the total efficacy rate (p > .05). The 24 h urinary protein excretion and serum cholesterol levels in both groups decreased after therapy and the serum levels of albumin in both groups increased after therapy. There were significant differences between the results for the 24 h urinary protein excretion, serum levels of albumin and cholesterol in the two groups (p < .05). The treatments were well tolerated in both groups.
Conclusion: LEF combined with prednisone has a certain efficacy on the RNS and displays few adverse reactions. A large-sample, randomized double-blind controlled study and long-term follow-up are needed to verify the efficacy of LEF combined with prednisone.
Keywords: Leflunomide; cyclophosphamide; nephrotic syndrome; prednisone; proteinuria.