Abshire Thomas
Department of Pediatrics, Aflac Cancer Center, and Blood Disorders Service, Emory University and Children's Healthcare of Atlanta, Atlanta, GA, USA.
Semin Hematol. 2008 Apr;45(2 Suppl 1):S3-6. doi: 10.1053/j.seminhematol.2008.03.006.
Recombinant activated factor VII (rFVIIa) appears to be safe when used for its licensed indication of congenital and acquired hemophilia A or B with inhibitors. One should carefully consider the clinical indication for which the agent is used when patient risk factors are present that might predispose the subject to a thromboembolic (TE) event, or when concomitant hemostatic agents are being used. Additionally, one should exercise caution if there is evidence of activated coagulation, such as that seen with excessive tissue factor release or disseminated intravascular coagulation. However, the incidence of serious TE events in hemophilia patients with inhibitors treated with rFVIIa appears to be much less than 1%. The role of rFVIIa in off-label indications should be assessed through rigorously controlled clinical trials or by analyzing carefully collected data from national and international registries.
重组活化凝血因子 VII（rFVIIa）用于其获批的先天性和获得性血友病 A 或 B 伴抑制剂的适应症时似乎是安全的。当存在可能使患者易发生血栓栓塞（TE）事件的危险因素，或正在使用其他止血药物时，应仔细考虑使用该药物的临床适应症。此外，如果有活化凝血的证据，如过度组织因子释放或弥散性血管内凝血所见，也应谨慎使用。然而，接受 rFVIIa 治疗的血友病伴抑制剂患者发生严重 TE 事件的发生率似乎远低于 1%。rFVIIa 在非适应症中的作用应通过严格对照的临床试验或仔细分析从国家和国际登记处收集的数据来评估。
