Med Lett Drugs Ther. 2010 Nov 15;52(1351):89-90.
The FDA has approved the oral direct thrombin inhibitor dabigatran (da big' a tran) etexilate (Pradaxa--Boehringer Ingelheim) for prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation.It has been available in Canada (Pradax) since 2008 for prevention of thromboembolism in patients undergoing knee or hip replacement surgery and was recently approved there for use in atrial fibrillation.
美国食品药品监督管理局(FDA)已批准口服直接凝血酶抑制剂达比加群酯(Pradaxa,勃林格殷格翰公司生产)用于预防非瓣膜性心房颤动患者的血栓栓塞性中风。自2008年以来,该药在加拿大以Pradax的名称上市,用于预防接受膝关节或髋关节置换手术患者的血栓形成,最近在加拿大也被批准用于心房颤动。