Abstract: Objective  To evaluate the efficacy and safety of sequential therapy with leflunomide(LEF) and cyclophosphamide(CYC) in systemic lupus erythematosus(SLE). Methods  Totally 45 patients with SLE were recruited and randomly divided into two groups treatment group and control group. Patients of recent onset who had not used any immunosuppressive drugs were given either  Ⅳ  cyclophosphamide for 12  weeks (intravenously 0.6 g for two weeks)， then were administrated with oral LEF for 12 weeks(20 mg/d) (treatment group) or  Ⅳ  cyclophosphamide (intravenously 0.6 g for two weeks)(control group) for 24 weeks. SLE disease activity index (SLEDAI)， clinical and immunological tests were performed in the patients. The efficacy and safety of the drugs were evaluated at 24 weeks after treatment. Results  SLEDAI improved similarly in both groups after 24 weeks of treatment. Major adverse events  in both groups were infection and alopecia. Conclusion  CYC combined with  LEF  was more effective and safe in the induction therapy of SLE especially in reproductive aging female patients.

Key words: lupus erythematosus, systemic；leflunomide； cyclophosphamide； sequential