Briseid G, Arntzen F C
Statens legemiddelkontroll Sven Oftedals vei 6, Oslo.
Tidsskr Nor Laegeforen. 1995 Jun 10;115(15):1849-51.
Recombinant factor VIII (Baxter) is approved by the Norwegian Medicines Control Authority. The product represents an alternative to plasma-derived factor VIII in the treatment of patients with haemophilia A. Its use should be guided by clinical experts in care of haemophilia. Characterization studies of this and another recombinant factor VIII preparation have revealed no significant differences from plasma-derived factor VIII as regards biochemical and functional properties. Clinical studies have demonstrated similar in vivo recovery, plasma half-life and haemostatic activity as for plasma-derived factor VIII. Recombinant factor VIII should carry a low, if any, risk of transmitting blood-borne viruses pathogenic to man. The product includes pasteurized human albumin added as stabilizer, which has a well-documented safety record. There is no clear evidence of increased incidence of factor VIII inhibitors than with plasma-derived factor VIII. Further long-term surveillance studies are needed, however, to elucidate these matters.
重组凝血因子VIII（百特公司生产）已获挪威药品管理局批准。该产品是治疗甲型血友病患者时血浆源性凝血因子VIII的替代物。其使用应由血友病护理方面的临床专家指导。对该重组凝血因子VIII制剂及另一重组凝血因子VIII制剂的特性研究表明，在生化和功能特性方面，与血浆源性凝血因子VIII并无显著差异。临床研究已证明，其体内回收率、血浆半衰期和止血活性与血浆源性凝血因子VIII相似。重组凝血因子VIII传播对人类致病的血源病毒的风险即便有也很低。该产品含有作为稳定剂添加的经巴氏消毒的人白蛋白，其安全记录有充分文件证明。没有明确证据表明，与血浆源性凝血因子VIII相比，凝血因子VIII抑制物的发生率会增加。不过，需要进一步开展长期监测研究来阐明这些问题。
