Abstract:

ABSTRACT：Objective：We conducted a prospective randomized clinical trial to evaluate the therapeutic efficacy and safety of combined regime of tripterygium wilfordii (TW) with steroid (P), compared with tacrolimus (FK506) with P in IMN patients. Methodology: One hundred cases of biopsy-proven IMN with a large amount of proteinuria >3.5g/24h were enrolled in this clinical trial. They were randomized divided into TW group (n=50) and FK506 (n=50). After the immunosuppressive agents were withdrawn, the relapse rate was observed for another 6 months The primary efficacy endpoint was effective rate (complete + partial remission rate) of 12 months. Result: The effective rate after 12 months of the TW group and FK506 group was 76.9% and 79.9% respectively, and the lower bound of the 95% CI for the treatment difference between two groups was 21.3%, which was greater than the prespecified noninferiority margin of 25.0%. The effective rate after 6 months of TW group and FK506 group was 70.0% and 74.9%, and the lower bound of the 95% CI was 24.9%. The complete remission rate was 8.8% and 31.7% after 6 and 12 months treatment in TW group, while it were 10.6% and 33.7% in FK506 group, respectively. The relapse rate of TW group was 30.6%, while FK506 group was 52.5%. During the treatment, there were more patients in FK506 group got the double increase of serum creatinine and new onset hypertension than in TW group, but there were menstrual disorder of most women of childbearing age in TW group. Conclusion: Tripterygium wilfordii combined with steroid is a useful therapy to reduce proteinuria in patients with IMN. It’s not inferior to that of tacrolimus combined with steroid, better for the preserve of renal function and has less rate of relapse. TW is a promising therapeutic option for patients with IMN.

Key words: Tripterygium Wilfordii - Idiopathic membranous nephropathy &ndash, Tacrolimus - remission rate