Brackmann H H, Aygören E, Scharrer I, Schwaab R, Hammerstein U, Oldenburg J
Institute of Experimental Haematology and Transfusion Medicine, University of Bonn, Germany.
Blood Coagul Fibrinolysis. 1993 Jun;4(3):421-4. doi: 10.1097/00001721-199306000-00004.
Transmission of infectious diseases via the use of plasma concentrates has lent special significance to the manufacture of recombinant coagulation factor concentrates. At present, two factor VIII concentrates manufactured by recombinant DNA technology, produced by Baxter (Recombinate) and Bayer/Miles (Kogenate), are undergoing clinical trials. At the haemophilia centres in Bonn and Frankfurt am Main a total of 4.1 million IU have been used by twelve patients for prophylaxis and treatment for bleeding between 1989 and 1990. The clinical efficacy, particularly in the treatment of bleeding episodes was good and corresponded with that of plasma-derived concentrates. There were no allergic reactions, development of inhibitors or other serious side effects. In laboratory investigations no adverse results were encountered.
通过使用血浆浓缩物传播传染病使得重组凝血因子浓缩物的生产具有了特殊意义。目前，由百特公司（重组八因子）和拜耳/迈尔斯公司（科跃奇）采用重组DNA技术生产的两种凝血因子VIII浓缩物正在进行临床试验。1989年至1990年间，波恩和美因河畔法兰克福的血友病治疗中心共有12名患者使用了总计410万国际单位的该浓缩物进行出血预防和治疗。其临床疗效，尤其是在治疗出血发作方面效果良好，与血浆来源的浓缩物相当。未出现过敏反应、抑制剂产生或其他严重副作用。在实验室研究中也未遇到不良结果。
