[Comparative study of the conventional scheme and prolonged treatment with steroids on primary steroid-sensitive nephrotic syndrome in children].

BACKGROUND

In the steroid-sensitive nephrotic syndrome (SSNS) the prolonged treatment with steroids could decrease the frequency of relapses. We conducted a comparative study of prolonged steroid scheme and the usual treatment of primary SSNS to assess: the number of patients with relapses, mean time to treatment initiation, to remission and to first relapse, total number of relapses, total cumulative dose of steroids, and the steroid toxicity.

METHODS

Patients were divided into two groups: group A (27 patients) received 16-β-methylprednisolone for 12 weeks, reducing the steroid until week 24. Group B (29 patients) received 16-β-methylprednisolone for 12 weeks and placebo until week 24.

RESULTS

Cumulative incidence rate of relapse (person/years) for group A was of 36/100 and 66/100 for group B (p=0.04). Average elapsed time to first relapse was of 114 days for group A and of 75 days to for group B (p=0.01). The difference in time for initial response to treatment and up to achieve remission between both groups was not significant. Total cumulative relapses were 9 for group A and 17 for group B (p=0.04). Total patients with relapses were 3 for group A and 7 for group B (p=0.17). Cumulative average dose per patient was 5,243mg/m2 for group A and 4,306mg/m2 for group B (p=0.3), and serum cortisol was 14μg/dl for group A and 16μg/dl for group B (p=0.4). There were no steroid toxicity differences between groups.

CONCLUSIONS

The duration of the treatment had an impact on the number of relapses without increasing steroid toxicity.