美国FDA于2013年12月23日批准Tretten用于治疗成人与儿童先天性凝血因子ⅩⅢ-A缺乏症(congenital factorⅩⅢA-subunit deficiency),适用于患者日常预防出血。先天性凝血因子ⅩⅢ缺乏症是一种极其罕见的遗传性凝血障碍。凝血因子ⅩⅢ分为A、B两种亚型(subunit),存在于血液循环系统中,对正常的凝血反应起着重要的作用。先天性凝血因子ⅩⅢ缺乏症患者自身血液中不能产生足够的凝血因子ⅩⅢ,通常该病是由于缺少或不能产生足够的ⅩⅢ-A因子引起的。 US FDA approved Tretten on December 23, 2013 for the treatment of adult and pediatric congenital factor XIII-A deficiency (subgenitial XIII-A deficiency), for use in patients’ daily prevention of bleeding. Congenital coagulation factor XIII deficiency is an extremely rare hereditary coagulopathy. Factor XIII is divided into A and B subunits, which exist in the blood circulation system and play an important role in the normal coagulation reaction. Patients with congenital clotting factor XIII deficiency can not produce sufficient clotting factor XIII in their own blood, usually due to the lack or inability to produce sufficient factor XIII-A.