Pharmacokinetics, efficacy and safety of Humate‐P<sup>®</sup> in von Willebrand disease

書誌事項

公開日
1998-11
権利情報
  • http://onlinelibrary.wiley.com/termsAndConditions#vor
DOI
  • 10.1046/j.1365-2516.1998.0040s3033.x
公開者
Wiley

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説明

<jats:p>In a pharmacokinetic study with Humate‐P<jats:sup>®</jats:sup> including six patients with various types of von Willebrand disease, a median half‐life of 11.3 h for vWF:RCoF and of 15.2 h for vWF:Ag was found. The median value of <jats:italic>in vivo</jats:italic> recovery (IVR) was estimated for vWF:RCoF as 2.10 IU dL<jats:sup>−1</jats:sup> plasma per 1 substituted IU kg<jats:sup>−1</jats:sup> b.w. (or 73%), for vWF:Ag as 1.88 IU dL<jats:sup>−1</jats:sup> plasma per 1 substituted IU kg<jats:sup>−1</jats:sup> b.w. (or 69%); and for FVIII:C as 2.69 IU dL<jats:sup>−1</jats:sup> plasma per 1 IU kg<jats:sup>−1</jats:sup> b.w. (or 99%). Transient postinfusion shortening or normalization of previously prolonged bleeding time was observed in all patients. In a retrospective study involving 97 patients with various von Willebrand disease types, clinical efficacy and safety of treatment with Haemate‐P<jats:sup>®</jats:sup> in 73 surgical interventions, 344 separate bleeding events, 93 other events and 20 cycles of prophylactic treatment were evaluated. The clinical efficacy was rated good to excellent in 99% of the surgeries, in 97% of the bleeding episodes, in 86% of the other events, and in all prophylactic treatments. The overall tolerability was good. Adverse events possibly or probably associated with use of Humate‐P<jats:sup>®</jats:sup>/Haemate‐P<jats:sup>®</jats:sup> were rare, of non‐serious nature and mild to moderate in their intensity.</jats:p>

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