Abstract:

ABSTRACT Objective：To investigate the long-term effect of triptergium wilfordii on maintenance therapy of proliferative lupus nephritis (LN) patients, comparing with azathioprine. Methodology：Eighty six patients with proliferative LN who received complete remission or partial remission from January 2007 to June 2008 were enrolled into this clinical trial. Before taking experimental drugs, two patients withdrew consents. According to the regimen of treatment, they were randomized to either triptergium wilfordii (TW) group or azathioprine (AZA) group. The duration of maintenance therapy was 24 months. The primary end point was the rate of relapse (renal flare and extrarenal flare). The secondary assessments included time to relapse, rate of reaching renal endpoint patients (renal endpoint was defined as end-stage renal disease, doubling of the serum creatinine level, or a change of -30% or greater in estimated GFR), changes of proteinuria and SCr during treatment, adverse effects. The long term effects between two regimens of maintenance therapy for LN were compared. Results：The median follow-up was 57.5 months（interquartile range 18.8，69.0 months）. The rate of relapses was similar between two groups, while the media time of the relapse was 17.5 months （interquartile: 5,56）in TW and 38 months（interquartile: 3,75） in AZA group, respectively. There was no significantly difference of serum creatinine, proteinuria and the level of anti-dsDNA between two groups during the first two years. Although the adverse events was higher in TW group （75.0%） than that in AZA group（59.1%）, but there was no statistical difference. The incidence of amenorrhea in TW group was significantly higher than that in AZA group while leukopenia was higher in AZA group. Both groups had a similar incidence of infection. Conclusion：Triptergium wilfordii had the similar relapse rate as azathioprine and similar adverse effects except for menstrual disorder. So triptergium wilfordii may be one of ways for maintenance therapy of lupus patients.

Key words:  lupus nephritis, maintenance therapy, Triptergium wilfordii , Azathioprine, adverse events