Clinical experience with recombinant factor VIIa.
Clinical experience with recombinant factor VIIa.
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重组因子 VIIa 的临床经验。
DOI：
10.1097/00001721-199803000-00002
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发表时间：
1998
期刊：
影响因子：
--
通讯作者：
U. Hedner
中科院分区：
文献类型：
--
作者：
J. Lusher;J. Ingerslev;H. Roberts;U. Hedner
重组凝血因子VIIa（rFVIIa）代表了使用抑制剂治疗血友病患者的一项重大治疗进展。已在400多例血友病A或B（有或无抑制剂）或获得性血友病患者的1900多例手术和非手术出血事件中广泛研究了rFVIIa的疗效和安全性。在103例可评价的手术出血事件中，分别有81%、86%和92%的严重、轻微和牙齿出血事件对rFVIIa治疗的反应被认为是极好或有效的。在518例严重出血事件中评价了治疗，62%的肌肉、80%的耳鼻咽喉、88%的中枢神经系统、76%的关节和75%的内部或腹膜后出血事件的反应被认为是极好或有效的。还证明了出色的安全性：在1957例rFVIIa治疗中，仅报告了16起被认为可能但不一定与治疗相关的严重不良事件。
Recombinant factor VIIa (rFVIIa) represents a major therapeutic advance in the treatment of haemophilia patients with inhibitors. The efficacy and safety of rFVIIa has been extensively studied in over 1900 surgical and non-surgical bleeding episodes in over 400 patients with haemophilia A or B (with or without inhibitors) or acquired haemophilia. Of 103 evaluable surgical bleeding episodes, the response to treatment with rFVIIa was considered to be either excellent or effective in 81%, 86% and 92% of major, minor and dental bleeding episodes, respectively. Treatment has been evaluated in 518 serious bleeding episodes and the response was considered either excellent or effective in 62% of muscle, 80% of ear, nose and throat, 88% of central nervous system, 76% of joint, and 75% of internal or retroperitoneal bleeding episodes. An excellent safety profile has also been demonstrated: of 1957 treatments with rFVIIa, only 16 serious adverse events have been reported that were considered to be possibly, but not necessarily, related to treatment.