小児肝移植患者における静注ganciclovirと経口valganciclovirのAUC同等性比較と有効性・安全性に関する検討

DOI
  • 齊藤 順平
    国立研究開発法人国立成育医療研究センター薬剤部
  • 石原 里美
    国立研究開発法人国立成育医療研究センター薬剤部
  • 内田 孟
    国立研究開発法人国立成育医療研究センター臓器移植センター
  • 佐々木 健吾
    国立研究開発法人国立成育医療研究センター臓器移植センター
  • 成本 壮一
    国立研究開発法人国立成育医療研究センター臓器移植センター
  • 阪本 靖介
    国立研究開発法人国立成育医療研究センター臓器移植センター
  • 福田 晃也
    国立研究開発法人国立成育医療研究センター臓器移植センター
  • 笠原 群生
    国立研究開発法人国立成育医療研究センター臓器移植センター
  • 石川 洋一
    国立研究開発法人国立成育医療研究センター薬剤部

書誌事項

タイトル別名
  • Estimation and comparison of ganciclovir exposure following intravenous ganciclovir or oral valganciclovir administration and the effect of ganciclovir exposure on the efficacy and safety in pediatric patients after liver transplantation

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抄録

<p>【Objective】Ganciclovir (GCV) and valganciclovir (VGCV) are used for the treatment and preemptive therapy of cytomegalovirus infection in pediatric liver transplantation patients. A GCV 24-hour area under the time-concentration curve (AUC0-24) of 40 – 60 μg/mL⋅hr is related to efficacy. The primary objective was to compare systemic exposures of GCV in patients administered GCV or VGCV using AUC0-24. Secondary objectives were the evaluation of causal relationships between AUC0-24 and efficacy or adverse effects.<br/> 【Study Design】Retrospective case series study.<br/> 【Methods】A limited sampling strategy was used to estimate AUC0-24. The time to a clearance of pp65 antigenemia was used as an efficacy, and incidences of renal and hematological toxicity were used as a safety.<br/> 【Results】Twenty-two pediatric liver transplantation patients were enrolled in the study. Estimated AUC0-24 using 2 sampling times (2 – 3 and 6 – 8 hours after administration) showed a good predictive performance by the Bayesian approaches. Ten patients were included in the AUC0-24 equivalence study and the mean AUC0-24 ratio (VGCV/GCV) was 1.04. In this study, a higher inter-individual variability in AUC0-24 was observed after VGCV administration. In efficacy evaluation, a slower clearance of pp65 antigenemia was observed in patients with AUC0-24 of less than 40. Incidences of renal and hematological toxicity tend to be higher in patients with AUC0-24 more than 60, although not significant differences were noted between AUC0-24 groups.<br/> 【Conclusions】In this study, the systemic exposure of GCV following VGCV and GCV administration was equivalent. Lower exposure may cause prolongation of the dosing period, and long-term administration threatens patients with renal and hematological toxicity.</p>

収録刊行物

  • 移植

    移植 52 (4-5), 366-373, 2017

    一般社団法人 日本移植学会

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