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首页> 外文期刊>Clinical and applied thrombosis/hemostasis >A Comparison Between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients With Congenital Factor VII Deficiency
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A Comparison Between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients With Congenital Factor VII Deficiency

机译：先天性凝血因子VII缺乏症患者中重组活化因子VII（Aryoseven）和Novoseven的比较

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摘要

In order to establish the efficacy and biosimilar nature of AryoSeven to NovoSeven in the treatment of congenital factor VII (FVII) deficiency, patients received either agent at 30 g/kg, intravenously per week for 4 weeks, in a randomized fashion. The primary aim was to compare FVII:coagulation activity (FVII:C), 20 minutes after recombinant activated FVII (rFVIIa) injection, in the 2 groups. A secondary measure was self-reported bleeding. The median interquartile baseline range of the plasma level of activated FVII (FVIIa) activity in the 2 groups was 1.6 (1.1-14.0) IU/dL and 5.0 (1.1-25.5) IU/dL. All patients achieved levels of FVIIa (FVII:C) >30 IU/dL, 20 minutes after the injection of rFVIIa. Bleeding was similar between the 2 groups, with a comparable decrease in severity and frequency compared to the last month prior to treatment. AryoSeven is similar to NovoSeven in increasing postinjection FVIIa activity as well as in clinical safety and efficacy.
机译：为了确定AryoSeven与NovoSeven在治疗先天性因子VII（FVII）缺乏症方面的功效和生物相似性，患者以随机方式每周30毫克/千克静脉内连续4周接受两种药物之一。主要目的是比较两组中重组活化FVII（rFVIIa）注射后20分钟的FVII：凝血活性（FVII：C）。次要措施是自我报告的出血。两组中激活的FVII（FVIIa）活性的血浆水平的四分位数基线范围为1.6（1.1-14.0）IU / dL和5.0（1.1-25.5）IU / dL。在注射rFVIIa后20分钟，所有患者的FVIIa（FVII：C）水平均> 30 IU / dL。两组之间的出血相似，与治疗前的最后一个月相比，其严重程度和发生频率有相当的下降。 AryoSeven在增加注射后FVIIa活性以及临床安全性和功效方面类似于NovoSeven。

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