【摘要】 凝血酶原复合物(PCC)是一种在临床上广泛用于治疗乙型血友病和由肝疾患、维生素K缺乏而继发的Ⅱ、Ⅶ、Ⅸ、Ⅹ因子缺乏症的血浆蛋白制品,传统的PCC存在病毒污染和潜在诱发血栓形成的高度危险性。本文对笔者所研制的经国际公认灭活病毒有效的有机溶济/表面活性剂(S/D)法处理的新型PCC及传统PCC进行了质量考察,重点对PCC的凝血因子活性及潜在致血栓性的杂蛋白进行分析探讨,结果显示新型PCC的Ⅱ、Ⅶ、Ⅸ、Ⅹ因子的比活性(u/mg)均比传统PCC约高1.5～2.5倍。同时也优于国内同类研制产品(P<0.05)。该结果提示随着新型PCC纯度的提高其相应的血栓副作用得以明显改善。此外,还对制品中与凝血抗凝及纤溶有关的杂蛋白进行了初探以进一步阐明新型PCC的血栓安全性。更多还原

【Abstract】 Prothrombin complex concentrates(PCC) are currently Licensed for the treatment of Hemophilia B and of the deficiencies of the Vitamin K - Dependent coagulation factor. Old PCC carry a significant risk of throm -boembolic complications and blood - borne viruses transmission. Here we have developed a new PCC product using solvent/detergent treatment to inactivate viruses,Which is Compared with the old product in qualities,emphatically of coagulation factor activity and potential thrombigenicity. Experimental results showed that the specific activities of Ⅱ,Ⅶ,Ⅸ,Ⅹ factor of the new PCC product are incrased by 1.5 - 2.5 times that of the old one. and are superior to the other domestically made products. It suggusts that the adverse effects of new PCC have been apparently decreased with the improvement of purity. In addition, Preliminary exploration of impure protein components in product that are concerned in coagulative, anticoagulative and fibrinolysis, so as to further explain the thrombosis safety of the new PCC.更多还原