NEJM:Idarucizumab在使用达比加群数分钟内能够完全逆转抗凝作用

2015-08-08 MedSci MedSci原创

    目前非维生素K拮抗剂口服抗凝剂缺乏具体的逆转剂。Idarucizumab,一种抗体片段,被研发出来逆转达比加群的抗凝作用。    研究人员进行了这项前瞻性队列研究,来确定静注5克idarucizumab和其逆转达比加群对于患有严重出血(A组)或需要紧急手术(B组)患者的抗凝作用安全性的能力。主要终点是在中央实验室确定稀释凝血酶时间或蝰蛇毒凝血时间基础

目前非维生素K拮抗剂口服抗凝剂缺乏具体的逆转剂。Idarucizumab,一种抗体片段,被研发出来逆转达比加群的抗凝作用。

研究人员进行了这项前瞻性队列研究,来确定静注5克idarucizumab和其逆转达比加群对于患有严重出血(A组)或需要紧急手术(B组)患者的抗凝作用安全性的能力。主要终点是在中央实验室确定稀释凝血酶时间或蝰蛇毒凝血时间基础上,idarucizumab给药后4小时内达比加群的的抗凝血作用逆转的最大百分比。一个关键的次要终点是止血的恢复。一项有关Idarucizumab在健康人群中的研究,也于近期发表,结果与本研究相似,详细见:Lancet:Idarucizumab可在5分钟内逆转达比加群作用,且耐受良好

这个中期分析包括接受idarucizumab的90例患者(A组51例,B组39例)。在基线时其中68例患者稀凝血酶时间升高,81例患者蝰蛇毒凝血时间升高,平均最大逆转百分比为100%(95%置信区间,100-100)。Idarucizumab使88例患者(98%)的测试结果归一化,在几分钟之内就有很明显的效果。79%的患者在24小时的时候未结合的达比加群的浓度仍低于每毫升20纳克。其中A组35例患者可以进行评估,止血,由当地调查员决定,恢复的中位数为11.4小时。其中B组36例患者接受手术治疗,其中33例被报道有正常的术中止血,轻度或中度异常止血分别有2例和1例。idarucizumab施用后72小时内发生1例血栓形成事件,该患者的抗凝治疗尚未重新启动。

该研究显示,Idarucizumab在使用达比加群数分钟内能够完全逆转抗凝作用。

原始出处:

Pollack CV Jr1, Reilly PA, Eikelboom J, et al,Idarucizumab for Dabigatran Reversal,NEJM,2015.8.6

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