Maraganore J M, Adelman B A
Biogen, Inc., Cambridge, Massachussetts, USA.
Coron Artery Dis. 1996 Jun;7(6):438-48.
Hirulog therapy has been studied extensively in numerous settings including prevention of DVT, treatment of unstable angina, treatment of acute myocardial infarction during thrombolysis, and prevention of acute complications of PTCA. Being one of the first direct thrombin inhibitors in clinical development, it has had to 'test the waters', so to speak, of the relationship between pathophysiology and clinical trial design: what are the correct indications, patient entry criteria, endopoints, frequency and duration of dosing, and so on? Our findings validate a role for thrombin in treating arterial thromboembolism and demonstrate clinical activity and tolerability of Hirulog.
希鲁洛治疗法已在多种情况下得到广泛研究,包括预防深静脉血栓形成、治疗不稳定型心绞痛、溶栓治疗急性心肌梗死以及预防经皮冠状动脉腔内血管成形术(PTCA)的急性并发症。作为首批进入临床开发的直接凝血酶抑制剂之一,可以说它一直在探索病理生理学与临床试验设计之间的关系:正确的适应症、患者入选标准、终点指标、给药频率和持续时间等等是什么?我们的研究结果证实了凝血酶在治疗动脉血栓栓塞中的作用,并证明了希鲁洛的临床活性和耐受性。