FDA批准人凝血酶原复合物紧急逆转大出血

　　2013年4月29日，美国食品与药物管理局（FDA）批准了人凝血酶原复合物（Kcentra）上市，以紧急逆转用维生素K拮抗剂（VKA）抗凝所致的成人大出血。在美国，Plasma是获准用于上述治疗的另外唯一一项产品。

　　心房颤动或人工心脏瓣膜置换患者一般应用华法林和其他VKA进行抗凝治疗，但有时有急性大出血的危险。类似于Plasma，Kcentra联合维生素K一起逆转抗凝效应并阻止出血。与Plasma不同的是，应用Kcentra无需血型分型或解冻，因此该药比Plasma更便捷。

　　FDA相关负责人表示，Kcentra可显著降低Plasma的推荐用量，为那些需逆转VKA抗凝且不耐受Plasma的患者提供了另一种治疗方法。

　　Kcentra在适应证范围内应用与血栓发生相关，该药说明书的加框警告提醒了该项风险。警告项也提示，应监测接受Kcentra治疗的患者血栓事件发生的临床表现；在临床试验和上市后监督中，也报告有致命性和非致命性动、静脉和血栓栓塞并发症。

　　Kcentra来源于健康捐献者的混合血浆，已经过病毒和其他疾病传播风险滤过处理。FDA批准Kcentra是基于一项纳入216例患者的临床试验。试验结果显示，在阻止急性大出血方面，Kcentra 疗效类似于plasma。

与凝血酶相关的拓展阅读：

• NEJM：凝血酶原异常可能导致血栓症 更多信息请点击：有关凝血酶更多资讯

FDA approves Kcentra for the urgent reversal of anticoagulation in adults with major bleeding
The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.

Patients receiving chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions such as atrial fibrillation or the presence of an artificial heart valve sometimes develop acute bleeding. Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anticoagulation effect and stop the bleeding. Unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma.
 
“The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation," said Karen Midthun, M.D., director, Center for Biologics Evaluation and Research, FDA. “Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation.”
 
Kcentra is associated with the occurrence of blood clots when used as indicated, and carries a boxed warning regarding the risk of blood clots. The warning also explains that patients receiving Kcentra should be monitored for signs and symptoms of thromboembolic events, as both fatal and non-fatal arterial and venous thromboembolic complications have been reported in clinical trials and post marketing surveillance.
 
Kcentra is made from the pooled plasma of healthy donors. It is processed in a way to minimize the risk of transmitting viral and other diseases. The FDA approval of Kcentra was based on a study of 216 patients who had been receiving VKA anticoagulation and who had acute major bleeding along with a clotting test value indicative of anticoagulant use. Kcentra was demonstrated to be similar to plasma in terms of the ability to stop acute major bleeding.
 
CSL Behring is headquartered in King of Prussia, Pa. The product will be manufactured at CSL Behring's Marburg, Germany facility.