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World Journal of Pediatrics
Published in: World Journal of Pediatrics 3/2019

01-06-2019 | Nephrotic Syndrome | Original Article

Usefulness of mizoribine administration in children with frequently relapsing nephrotic syndrome, and the relationship between pharmacokinetic parameters and efficacy: a multicenter prospective cohort study in China

Authors: Zheng-Kun Xia, Yuan-Fu Gao, Li-Ping Rong, Xi-Qiang Dang, Qian Shen, Xiao-Yun Jiang, Zhu-Wen Yi, Hong Xu

Published in: World Journal of Pediatrics | Issue 3/2019

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Abstract

Background

Mizoribine (MZR) is an immunosuppressant used to treat adult nephropathy. There is little experience with the drug in treating Chinese children with frequently relapsing nephrotic syndrome (FRNS). We investigated the efficacy and safety for treating MZR with FRNS. Furthermore, the relationship between efficacy and serum concentration was investigated.

Methods

A prospective multicenter observational 12-month study was performed for evaluating the usefulness of MZR with FRNS. Serum MZR concentration was measured, and the relationships between pharmacokinetic parameters (Cmax, AUC), number of relapses, and urinary protein were evaluated.

Results

Eighty-two pediatric patients from four hospitals were treated with MZR and prednisone. MZR treatment significantly reduced the number of relapses and steroid doses. A correlation between pharmacokinetic parameters and relapses was observed, which fits well with the sigmoidal Emax model. Even in the relationship between pharmacokinetic parameters and urinary proteins, it was recognized that there was a threshold in the pharmacokinetic parameters for the therapeutic effect similar to the results obtained with the sigmoidal Emax model. Eleven patients (13.4%) experienced mild adverse events.

Conclusions

MZR therapy was effective in reducing the number of relapses and steroid doses. No severe adverse reactions were observed. Therapeutically effective serum concentrations were estimated to be Cmax ≥ about 2 μg/mL or AUC ≥ about 10 μg h/mL. MZR and steroid treatment were effective and safe for pediatric FRNS.
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Metadata
Title
Usefulness of mizoribine administration in children with frequently relapsing nephrotic syndrome, and the relationship between pharmacokinetic parameters and efficacy: a multicenter prospective cohort study in China
Authors
Zheng-Kun Xia
Yuan-Fu Gao
Li-Ping Rong
Xi-Qiang Dang
Qian Shen
Xiao-Yun Jiang
Zhu-Wen Yi
Hong Xu
Publication date
01-06-2019
Publisher
Springer Singapore
Published in
World Journal of Pediatrics / Issue 3/2019
Print ISSN: 1708-8569
Electronic ISSN: 1867-0687
DOI
https://doi.org/10.1007/s12519-019-00241-7

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