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Clinical efficacy and safety of moroctocog alfa

机译：阿尔法莫克托克的临床疗效和安全性

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The mainstay of treatment for patients with hemophilia A is replacement with either plasma-derived or recombinant (r) coagulation factor (F)VIII. As compared with whole plasma, plasma-derived FVIII concentrates clearly improved the clinical outcome for patients with hemophilia A; however, their use was associated with the transmission of blood-borne viruses such as hepatitis B and C virus and HIV, and prompted the introduction into clinical use of biotechnologically engineered recombinant clotting factor concentrates, with a much lower theoretical risk of transfusion-associated infections. Continued efforts to further improve safety have led to the introduction of newer generations of rFVIII, with each subsequent generation representing an incremental step with regard to pathogen safety. Between 1980 and 1985, research demonstrated that removing the middle portion (the B-domain) of wild-type FVIII protein had no detrimental effect on its procoagulant activity as assessed in vitro. This finding was the basis for the development of a recombinant B-domain-deleted FVIII (BDDrFVIH), moroctocog alfa (ReFacto~R). Moroctocog alfa albumin-free cell culture (ReFacto AF~R in Europe, Xyntha~R in the USA) has been developed as a successor to ReFacto. The aim of this article is to describe the clinical evidence about moroctocog alfa and moroctocog alfa albumin-free cell culture.
机译：A型血友病患者的主要治疗方法是用血浆来源的或重组（r）凝血因子（F）VIII替代。与全血浆相比，血浆来源的FVIII浓缩物明显改善了A型血友病患者的临床结局。然而，它们的使用与诸如乙型和丙型肝炎病毒以及艾滋病毒等血源性病毒的传播有关，并促使将生物技术改造的重组凝血因子浓缩物引入临床应用，与输血相关感染的理论风险要低得多。 。不断努力以进一步提高安全性已导致引入了新的rFVIII世代，随后的每一代代表着病原体安全性的递增步骤。在1980年至1985年之间，研究表明，如在体外评估的那样，去除野生型FVIII蛋白的中间部分（B结构域）对其促凝活性没有不利影响。该发现是开发重组B结构域缺失的FVIII（BDDrFVIH），苜蓿八蛋（Reoctacog）的基础。已开发出不含Moroctocog alfa白蛋白的细胞培养物（欧洲为ReFacto AF〜R，美国为Xyntha〜R）作为ReFacto的后继产品。这篇文章的目的是描述有关阿尔莫莫克和无阿尔莫莫克的白蛋白细胞培养的临床证据。

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