Kcentra获准用于紧急逆转严重出血成年患者的抗凝治疗

圣路易斯(MD Consult)——2013年4月29日，美国食品药品管理局(FDA)宣布批准Kcentra(凝血酶原复合物)用于紧急逆转维生素K拮抗剂(VKA)对急性严重出血成年患者的抗凝作用。血浆是除Kcentra之外唯一获准在美国使用的对抗抗凝产品。与血浆不同的是，Kcentra并不需要血液分型或解冻，因此可以比冷冻血浆更快捷地使用。

在按适应证使用Kcentra时有可能发生血栓形成，该药的标签带有关于这一风险的加框警告。这则警告也解释了为何使用Kcentra的患者必须监测血栓栓塞事件症状和体征，因为在临床试验和上市后监测中已发生了致死性和非致死性的动静脉血栓栓塞并发症。

Kcentra是用健康供者的混合血浆制备的，其加工过程采用了尽可能降低病毒传播和其他疾病风险的方法。FDA批准Kcentra是基于一项纳入216例患者的研究，这些患者均接受了VKA抗凝并且发生了急性严重出血，而凝血试验结果提示应予以抗凝治疗。Kcentra被证明在阻止急性严重出血方面具有与血浆相似的效能。

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ST LOUIS (MD Consult) - On April 29, 2013, the US Food and Drug Administration (FDA) announced the approval of 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. Unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma.

Kcentra is associated with thrombosis when used as indicated, and the label carries a Boxed Warning regarding this risk. 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 granted on the basis of data from a study of 216 patients who had been receiving VKA anticoagulation and who had experienced 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.
 

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