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Mizoribine therapy combined with steroids and mizoribine blood concentration monitoring for idiopathic membranous nephropathy with steroid-resistant nephrotic syndrome.
- Source :
-
Clinical and experimental nephrology [Clin Exp Nephrol] 2017 Dec; Vol. 21 (6), pp. 961-970. Date of Electronic Publication: 2016 Oct 25. - Publication Year :
- 2017
-
Abstract
- Background: We designed a prospective and randomized trial of mizoribine (MZR) therapy combined with prednisolone (PSL) for idiopathic membranous nephropathy (IMN) with steroid-resistant nephrotic syndrome (SRNS).<br />Methods: Patients with IMN were divided into 2 groups, and MZR combined with PSL was administered for 2 years. PSL was initially prescribed at 40 mg/day and tapered. MZR was given once-a-day at 150 mg and 3-times-a-day at 50 mg each to groups 1 and 2. Serum MZR concentrations from 0 to 4 h after administration were examined within one month of treatment. The concentration curve and peak serum level (C <subscript>max</subscript> ) of MZR were estimated by the population pharmacokinetic (PPK) parameters of MZR.<br />Results: At 2 years, 10 of 19 patients (52.6 %) in group 1 and 7 of 18 patients (38.9 %) in group 2 achieved complete remission (CR). The time-to-remission curve using the Kaplan-Meier technique revealed an increase in the cumulative CR rate in group 1, but no significant difference between the groups. Meanwhile, there was a significant difference in C <subscript>max</subscript> between groups 1 and 2 (mean ± SD: 1.20 ± 0.52 vs. 0.76 ± 0.39 μg/mL, p = 0.04), and C <subscript>max</subscript> levels in CR cases were significantly higher than those in non-CR cases. Receiver operating characteristic analysis showed that C <subscript>max</subscript> more than 1.1 µg/mL was necessary for CR in once-a-day administration.<br />Conclusion: Administration of MZR once a day is useful when combined with PSL for treatment of IMN with SRNS. In addition, it is important to assay the serum concentration of MZR and to determine C <subscript>max</subscript> , and more than 1.1 µg/mL of C <subscript>max</subscript> is necessary for CR.
- Subjects :
- Adult
Aged
Female
Glomerulonephritis, Membranous complications
Glucocorticoids administration & dosage
Humans
Immunosuppressive Agents blood
Immunosuppressive Agents pharmacokinetics
Male
Middle Aged
Nephrotic Syndrome etiology
Prednisolone administration & dosage
Prospective Studies
Ribonucleosides blood
Ribonucleosides pharmacokinetics
Glomerulonephritis, Membranous drug therapy
Immunosuppressive Agents administration & dosage
Nephrotic Syndrome drug therapy
Ribonucleosides administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1437-7799
- Volume :
- 21
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Clinical and experimental nephrology
- Publication Type :
- Academic Journal
- Accession number :
- 27783276
- Full Text :
- https://doi.org/10.1007/s10157-016-1340-2