Pulse cyclophosphamide therapy in steroid-dependent nephrotic syndrome.
Intravenous cyclophosphamide (IVCP) has been shown to be effective in lupus nephritis. This is a randomized controlled trial to compare the effectiveness of IVCP with oral cyclophosphamide (OCP) in patients with steroid-dependent (SD) idiopathic nephrotic syndrome (INS). Forty-seven consecutive children who were SD were randomized to receive either OCP (2 mg/kg per dayx12 weeks) or IVCP (500 mg/m(2) per month IVx6 months) after achieving a steroid-induced remission. The response was evaluated in terms of remission, change in steroid response status, duration of remission (i.e., proteinuria-free days), side effects, and compliance. Of the 47, IVCP was given to 26 children and OCP to 21 children. The demographic data, histopathology, biochemical profile, and duration of follow-up in the two groups were similar. On Kaplan-Meier survival analysis, the median proteinura-free time was 360+/-88 days compared with 96+/-88 days in the OCP group (values median+/-SE, log rank P=0.05). The actuarial cumulative sustained remission in our study was 73% in IVCP compared with 38.1% in OCP at 6 months after therapy, but was almost identical (18.6% in IVCP vs. 19%in OCP) after 2 years. Thus in our study the overall improvement in steroid response category from SD to sustained remission, infrequent relapser, and frequent relapser (88% in IVCP vs. 57% in OCP) was significantly better in the IVCP group, although the number of children with persistent remission tended to be similar at 2 years. Furthermore, the response was observed with a 40% lower cumulative dose than OCP. Hence, we conclude that IVCP is a safe and effective therapeutic modality in children with INS who are SD.
Prasad
Narayan
N
Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
Gulati
Sanjeev
S
Sharma
Raj Kumar
RK
Singh
Uttam
U
Ahmed
Muffazal
M
D000284:Administration, Oral; D000293:Adolescent; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007223:Infant; D007275:Injections, Intravenous; D008297:Male; D009404:Nephrotic Syndrome / Q000188:drug therapy*; D011239:Prednisolone / Q000627:therapeutic use; D016019:Survival Analysis
D000893:Anti-Inflammatory Agents; D018906:Antineoplastic Agents, Alkylating; D003520:Cyclophosphamide; D011239:Prednisolone