A randomized study of two long-course prednisolone regimens for nephrotic syndrome in children.
BACKGROUND
Long-course prednisolone regimens have been shown to be more effective than short-course regimens in sustaining remission of nephrotic syndrome in children. However, the most beneficial approach among the long-course regimens remains unknown.


METHODS
Seventy-three children with new-onset nephrotic syndrome were allocated at random to the two long-course regimens and followed up for 2 years. Group A was administered prednisolone at a daily dose of 60 mg/m2 for 6 weeks, followed by an alternate-day dose of 40 mg/m2 for 6 weeks (the long daily regimen). Group B was administered the same daily dose for 4 weeks, followed by an alternate-day dose of 60 mg/m2 for 4 weeks, and doses were tapered by 10 mg/m2 every 4 weeks (the long alternate-day regimen).


RESULTS
Group B had a lower incidence of corticosteroid toxicities than group A during the initial treatment. Kaplan-Meier analysis of the sustained remission rate of the two treatment groups showed a marginally significant difference (P = 0.069) and showed a significant difference when patients were stratified for age of disease onset (P = 0.048). In a subgroup of younger children (<4 years at onset), group B had a greater rate of sustained remission (P < 0.01) and fewer children with frequent relapses (P < 0.05) than group A, whereas in older children (> or =4 years at onset), both groups had similar good sustained remission rates.


CONCLUSIONS
These findings collectively indicate that the long alternate-day regimen may be more beneficial, with less corticosteroid toxicities, than the long daily regimen, and children with younger age at disease onset may be susceptible to relapse and especially benefit from the long alternate-day regimen for sustaining remission of the disease.
Hiraoka
Masahiro
M
Department of Pediatrics, Fukui Medical University School of Medicine, Fukui, Japan. hiraoka@fmsrsa.fukui-med.ac.jp
Tsukahara
Hirokazu
H
Matsubara
Kousaku
K
Tsurusawa
Masahito
M
Takeda
Nobuaki
N
Haruki
Shinichi
S
Hayashi
Shuhei
S
Ohta
Kazuhide
K
Momoi
Tohru
T
Ohshima
Yusei
Y
Suganuma
Narufumi
N
Mayumi
Mitsufumi
M
D000293:Adolescent; D000367:Age Factors; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007223:Infant; D015993:Life Tables; D008297:Male; D009404:Nephrotic Syndrome / Q000188:drug therapy*; D011239:Prednisolone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016016:Proportional Hazards Models; D012008:Recurrence; D012074:Remission Induction; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D011239:Prednisolone