Abstract | AIM: METHODS: The subjects were 8 patients with FR-SDNS with a median age of 6.9 years old (range 3.1 - 18.0 y). The study was performed as a Phase II trial. The MZB dose was adjusted to achieve a peak blood level of 3 - 5 μg/ml (3.9 - 15.9 mg/kg/d, maximum dose: 750 mg) using a single dose given twice weekly before a meal. The therapeutic benefits of MZB pulse therapy were assessed based on a comparison of the incidence of relapse and the required daily dosage of prednisolone (PSL) in the 12 months prior to and following therapy. RESULTS: The incidence of relapse after therapy was significantly lower than that before therapy (2.5 ± 1.4 vs. 4.3 ± 0.5, p < 0.01) and the required daily dosage of prednisolone (PSL) after therapy was lower than that before therapy (0.48 ± 0.23 vs. 0.52 ± 0.32 mg/kg/d, not significant). However, this therapy was not effective for 3 out of 4 patients treated with cyclosporine. During follow-up, discontinuation of PSL was possible in 4 of 5 patients who showed a decreased rate of relapse after therapy. The peak blood concentration of MZB in these patients was significantly higher than that in 3 patients who did not show a decreased rate of relapse (3.95 ± 0.11 vs. 3.05 ± 0.21 μg/ml, p < 0.01). No adverse effects were observed in any patients. CONCLUSION: Our results show that single-dose oral MZB pulse therapy is effective in decreasing the frequency of relapse in some pediatric patients with FR-SDNS. A peak concentration of MZB of ~3.8 - 4.0 μg/ ml may be required for FR-SDNS therapy.
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Authors | Mikiya Fujieda, Masayuki Ishihara, Taku Morita, Atsushi Hayashi, Shinichi Okada, Toshiyuki Ohta, Takashi Sakano, Hiroshi Wakiguchi |
Journal | Clinical nephrology
(Clin Nephrol)
Vol. 78
Issue 1
Pg. 40-6
(Jul 2012)
ISSN: 0301-0430 [Print] Germany |
PMID | 22732336
(Publication Type: Clinical Trial, Phase II, Journal Article)
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Chemical References |
- Immunosuppressive Agents
- Ribonucleosides
- Steroids
- mizoribine
- Cyclosporine
- Prednisolone
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Topics |
- Administration, Oral
- Adolescent
- Child
- Child, Preschool
- Cyclosporine
(therapeutic use)
- Female
- Humans
- Immunosuppressive Agents
(administration & dosage, blood, pharmacokinetics)
- Infant
- Japan
- Male
- Nephrotic Syndrome
(drug therapy)
- Prednisolone
(administration & dosage)
- Pulse Therapy, Drug
- Recurrence
- Ribonucleosides
(administration & dosage, blood, pharmacokinetics)
- Steroids
(administration & dosage)
- Time Factors
- Treatment Outcome
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