Arkin S, Cooper H A, Hutter J J, Miller S, Schmidt M L, Seibel N L, Shapiro A, Warrier I
Mount Sinai Medical Center, Mount Sinai School of Medicine, New York, N.Y., USA.
Haemostasis. 1998 Mar-Apr;28(2):93-8. doi: 10.1159/000022418.
Activated recombinant human coagulation factor VII (rFVIIa) is a promising new therapeutic agent for patients with hemophilia A or B with inhibitors who experience serious bleeding episodes or who need coverage during surgical procedures. This open-label, uncontrolled, emergency-use study evaluated the efficacy and safety of rFVIIa in 11 hemophiliac patients and 1 FVII-deficient patient with life-threatening intracranial hemorrhage previously unresponsive to one or more alternative therapies. rFVIIa effectively controlled intracranial hemorrhage in 10 of the 12 patients. Patients with hemophilia A or B received an average of 96.9 rFVIIa injections over 14.7 days with a mean total administration of 153.3 mg, corresponding to 8.1 mg/kg. Most reported adverse events were considered to be unrelated to rFVIIa therapy. These findings suggest that rFVIIa is an effective and well-tolerated therapeutic option in the management of central nervous system bleeding in patients with hemophilia A or B with inhibitors.
活化重组人凝血因子VII（rFVIIa）对于患有血友病A或B且产生抑制剂、经历严重出血事件或在外科手术期间需要预防出血的患者而言，是一种很有前景的新型治疗药物。这项开放标签、非对照的紧急使用研究评估了rFVIIa对11例血友病患者和1例FVII缺乏且患有危及生命的颅内出血、先前对一种或多种替代疗法无反应的患者的疗效和安全性。rFVIIa有效控制了12例患者中10例的颅内出血。患有血友病A或B的患者在14.7天内平均接受了96.9次rFVIIa注射，平均总给药量为153.3mg，相当于8.1mg/kg。大多数报告的不良事件被认为与rFVIIa治疗无关。这些发现表明，rFVIIa是治疗患有抑制剂的血友病A或B患者中枢神经系统出血的一种有效且耐受性良好的治疗选择。
