Association of Cumulative Cyclosporine Dose with Its Irreversible Nephrotoxicity in Japanese Patients with Pediatric-Onset Autoimmune Diseases

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  • Nakamura Tsutomu
    Department of Hospital Pharmacy, Kobe University School of Medicine
  • Nozu Kandai
    Department of Pediatrics, Kobe University Graduate School of Medicine
  • Iijima Kazumoto
    Department of Nephrology, National Center for Child Health and Development
  • Yoshikawa Norishige
    Department of Pediatrics, Wakayama Medical University
  • Moriya Yuka
    Department of Hospital Pharmacy, Kobe University School of Medicine
  • Yamamori Motohiro
    Department of Hospital Pharmacy, Kobe University School of Medicine
  • Kako Asae
    Department of Hospital Pharmacy, Kobe University School of Medicine
  • Matsuo Masafumi
    Department of Pediatrics, Kobe University Graduate School of Medicine
  • Sakurai Aki
    Department of Biomolecular Engineering, Graduate School of Bioscience and Biotechnology, Tokyo Institute of Technology
  • Okamura Noboru
    Department of Clinical Evaluation of Pharmacotherapy, Kobe University Graduate School of Medicine
  • Ishikawa Toshihisa
    Department of Biomolecular Engineering, Graduate School of Bioscience and Biotechnology, Tokyo Institute of Technology
  • Okumura Katsuhiko
    Department of Hospital Pharmacy, Kobe University School of Medicine Department of Clinical Evaluation of Pharmacotherapy, Kobe University Graduate School of Medicine
  • Sakaeda Toshiyuki
    Department of Hospital Pharmacy, Kobe University School of Medicine Center for Integrative Education of Pharmacy Frontier, Graduate School of Pharmaceutical Sciences, Kyoto University

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Cyclosporine (CsA)-induced nephrotoxicity can become a major obstacle to continuous use. The aim of this study was to optimize CsA dose to avoid its irreversible nephrotoxicity. Twenty-three Japanese patients with pediatric-onset systemic lupus erythematosus or idiopathic nephrotic syndrome, who were maintained in a stable condition by oral dosing of CsA microemulsion, were enrolled in this study. The patients were stratified into 3 groups; those with no, reversible, and irreversible nephrotoxicity, according to periodically performed renal pathohistological examinations. A higher concentration of CsA in blood (p=0.002—0.011) and a longer duration of CsA treatment (p=0.002) were risk factors for irreversible nephrotoxicity, and the cumulative CsA dose, the product of the maintenance dose and duration of CsA treatment, was predictive of nephrotoxicity (p=0.036). The maximum target blood concentration at 2 h post-dose, C2, to avoid CsA-induced irreversible nephrotoxicity was 700 ng/ml, although the cumulative CsA dose of 4850 mg/kg would result in a 50% probability of nephrotoxicity.

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