Abstract
Introduction: The most common complications of the nephrotic syndrome (NS) are the frequent relapses,
steroid resistance, and long-term steroid administration.
Objectives: This study aimed to compare the therapeutic effect of rituximab versus cyclophosphamide in
the prevention of relapses and the complications of treatment in children with steroid-resistant NS.
Patients and Methods: This clinical trial study was performed on 50 patients with resistant steroidal NS
referred to Masoumeh hospital in Qom, Iran. Patients were randomly divided into the two groups including
intervention (n=20) and control groups (n=30). In addition to the prednisolone, the intervention group
received 375 mg/m2/weekly rituximab intravenously for 4 weeks. The control group received oral doses
of cyclophosphamide 2 mg/kg/d for 3 months. During treatment, the frequency of relapses, the mean dose
of steroid and the complications of treatment were compared with a paired t-test, independent t-test, and
chi-square test.
Results: A significant decrease in the mean dose of steroids and the mean number of relapses were seen in
patients after administration of rituximab and cyclophosphamide (P<0.001). However, rituximab reduced
the dose of steroid administration by 12.25 mg/d, while cyclophosphamide reduced only 2.83 mg/d
(P<0.001). Rituximab reduced the relapse rate two times on average, while cyclophosphamide reduced
only 0.5 times (P<0.001). The incidence of complications in the cyclophosphamide group was found to be
more severe than the rituximab group.
Conclusion: To compare rituximab versus cyclophosphamide regarding lower the frequency of recurrence
after treatment, we found rituximab is a more suitable drug for the treatment of steroid-resistant NS than
cyclophosphamide.