Weiskopf R B
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark.
Vox Sang. 2007 May;92(4):281-8. doi: 10.1111/j.1423-0410.2006.00888.x.
Recombinant activated coagulation factor VII (rFVIIa) was developed initially for treatment of patients with hemophilia and neutralizing antibodies ("inhibitors") to coagulation factors VIII or IX. Owing to the unique and selective mechanism of action of rFVIIa and encouraged by clinical experience with other circumstances of inadequate hemostasis, a broad development program has been pursued to test potential efficacy and evaluate safety of this biologic for indications other than hemophilia. This review summarizes the current development of rFVIIa, focusing on results of prospective, randomized clinical trials.
重组活化凝血因子VII(rFVIIa)最初是为治疗血友病患者以及对凝血因子VIII或IX产生中和抗体(“抑制剂”)的患者而研发的。由于rFVIIa独特且具有选择性的作用机制,并且受到其他止血功能不足情况的临床经验的鼓舞,人们开展了一项广泛的研发计划,以测试这种生物制剂在血友病以外适应症方面的潜在疗效并评估其安全性。本综述总结了rFVIIa的当前研发情况,重点关注前瞻性随机临床试验的结果。