Efficacy and safety of mizoribine combined with losartan in the treatment of IgA nephropathy: a multicenter, randomized, controlled study.

摘要

INTRODUCTION: Few have tried to prove the effectiveness of mizoribine combined with losartan for adult IgA nephropathy patients in a randomized controlled trial. METHODS: A multicenter, randomized, controlled, 12-month study was performed to evaluated the efficacy and safety of mizoribine combined with losartan for adult IgA nephropathy. Ninety-nine patients with primary IgA nephropathy from 8 clinical institutions were randomly assigned to the losartan group (n = 30), the mizoribine group (n = 35) or the combination (losartan+mizoribine) group (n = 34). The primary outcome was 24-hour urinary protein excretion (24 hours-UP). RESULTS: There were no significant differences in baseline data among the 3 groups. In all 3 groups, 24 hours-UP after 3, 6, 9 and 12 months of treatment were significantly lower than the baseline level. The reduction in 24 hours-UP in the losartan group was observed early and reached maximum after 6 months of treatment. Twenty-four hours-UP in the mizoribine group and combination group continuously decreased during the study. Comparisons among the 3 groups showed that the losartan group was superior to the mizoribine group after 3 months of treatment, but that after 12 months of treatment, both the combination group and the mizoribine group were superior to the losartan group in the reduction of 24 hours-UP. There were no significant differences among the 3 groups in serum creatinine. No serious adverse events occurred in any of the 3 groups. CONCLUSIONS: The treatment of adult IgA nephropathy with mizoribine alone, losartan alone or a combination of the 2 reduced 24 hours-UP. Mizoribine and losartan, when used in combination, complement each other's activities.