Biopharmaceuticals Research Unit, Novo Nordisk A/S, Måløv, Denmark.
Thromb Res. 2010 Jun;125(6):483-9. doi: 10.1016/j.thromres.2009.11.027. Epub 2009 Dec 16.
Recombinant factor VIIa (rFVIIa, NovoSeven) is currently the only bypassing agent produced by recombinant technology for the treatment of haemophiliacs whose disease is complicated by inhibitory antibodies. In addition, recombinant production of FVIIa has made it widely available for a variety of purposes and accelerated the growth of our knowledge about FVIIa by generating an abundance of clinical and biochemical data. This fascinating molecule has turned out to be a safe haemostatic agent with great potential in the clinic and has inspired the generation of improved variants currently in (pre-)clinical testing. The present review describes the structural and functional aspects of FVIIa, followed by sections dealing with the manufacturing, therapeutic mechanism of action, clinical development and experience with rFVIIa.
重组因子 VIIa（rFVIIa，诺其）是目前唯一一种由重组技术生产的旁路制剂，用于治疗因抑制性抗体而复杂化的血友病患者。此外，FVIIa 的重组生产使其广泛用于多种用途，并通过产生大量的临床和生化数据，加速了我们对 FVIIa 的认识增长。这种引人入胜的分子已成为一种安全的止血剂，在临床上具有巨大的潜力，并激发了目前正在（临床前）临床试验中的改良变体的产生。本综述描述了 FVIIa 的结构和功能方面，随后是关于制造、治疗作用机制、临床开发和 rFVIIa 经验的部分。
