Cyclosporine and steroid therapy in children with steroid-resistant nephrotic syndrome |
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Authors: | Yuko Hamasaki Norishige Yoshikawa Shinzaburo Hattori Satoshi Sasaki Kazumoto Iijima Koichi Nakanishi Takeshi Matsuyama Kenji Ishikura Nahoko Yata Tetsuji Kaneko Masataka Honda |
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Affiliation: | 1. Department of Pediatric Nephrology, Tokyo Metropolitan Kiyose Children’s Hospital, 1-3-1 Umezono, Kiyose-city, Tokyo, 204-8567, Japan 2. Department of Pediatrics, Wakayama Medical University, Wakayama, Japan 3. Department of Fundamental Medicine, Kumamoto Health Science University, Kumamoto, Japan 4. Department of Pediatrics, Hokkaido University Graduate School of Medicine, Sapporo, Japan 5. Department of Pediatrics, Kobe University Graduate School of Medicine, Kobe, Japan 6. Department of Pediatrics, Fussa Hospital, Tokyo, Japan 7. Department of Clinical Research, Tokyo Metropolitan Kiyose Children’s Hospital, Tokyo, Japan 8. Department of Biostatistics/Epidemiology and Preventive Health Sciences, School of Health Sciences and Nursing, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan
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Abstract: | We conducted a prospective, multicenter trial to evaluate the efficacy and safety of a 12-month course of cyclosporine in children with steroid-resistant nephrotic syndrome (SRNS). Thirty-five patients were enrolled, of whom 28 had minimal change or diffuse mesangial proliferation (MC/DMP), and seven had focal segmental glomerulosclerosis (FSGS). All patients received cyclosporine and prednisolone; patients with FSGS additionally received methylprednisolone pulse therapy (MPT). The dose of cyclosporine was adjusted to maintain a trough level of 120–150 ng/ml during the initial 3 months of treatment, followed by 80–100 ng/ml during months 4–12. The primary end point was the remission rate at month 12. Remission was achieved in 23 of 28 (82.1%) patients in the MC/DMP group and in six of the seven (85.7%) patients in the FSGS group. Follow-up renal biopsies were performed in 26 patients (nine at month 12, 17 at month 24), and cyclosporine-related nephrotoxicity was detected in one (3.8%). Major adverse events comprised severe bacterial infections (two patients) and posterior reversible encephalopathy syndrome (one patient). In conclusion, a high remission rate was achieved in our patient cohort using a combined cyclosporine/prednisolone treatment regimen in children with SRNS who had MC/DMP and a combined cyclosporine/prednisolone plus MPT regimen in children who had FSGS. |
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