Efficacy and safety of cyclophosphamide combined with mycophenolate mofetil for induction treatment of class IV lupus nephritis.

The present study aimed to evaluate the efficacy and safety of combination of cyclophosphamide (CTX) and mycophenolate mofetil (MMF) as induction treatment in Chinese patients with class IV lupus nephritis (LN). 82 patients were randomly divided into control (CTX, n=40) and test (CTX+MMF, n=42) groups, and they received monthly dose of 0.75 g/m(2) of body surface area of CTX and monthly dose of 0.4 g/m(2) CTX plus 1.0 g/d MMF, respectively. Patients were followed up for six months after treatment; and their efficacy rates, complete remission rates, adverse events, and certain indices in blood were compared between the two groups. Compared with the baseline levels, significant differences in the levels of hemoglobin, urinary proteins, albumin, serum creatinine, erythrocyte sedimentation rate, complement C3 and anti-dsDNA were observed after treatment in both groups (P<0.05). While the two groups did not differ significantly after treatment (P>0.05). There was a trend toward higher complete remission (54.8%) and efficacy rates (88.1%) after treatment in the test group without statistical significance. However, the incidence rate of gastrointestinal reactions (7.1%) and infections (11.9%) in the test group were significantly lower than the control group (P<0.05). The efficacy of lower dose of CTX combined with MMF as induction therapy for LN was not lower than the traditional treatment with CTX. Moreover, the low dose of CTX in combination with MMF could result in lesser adverse events and improved safety.

RCT Entities:   Population Interventions Outcomes