新型抗凝血药物的临床研发和评价要点  

Clinical development and evaluation of new anticoagulants

作　　者：康彩练[1] 华尉利[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2012年第15期1711-1717,共7页Chinese Journal of New Drugs

摘　　要：血栓性疾病已经日渐成为影响人们健康的主要疾病,抗凝治疗一直是血栓性疾病的重要治疗手段。近年来新型抗凝血药物成为新药研发的重要热点之一,其中凝血因子Xa抑制剂和凝血酶(凝血因子II)抑制剂的研发引人关注。在这些凝血药物的临床试验和开发中,虽然其药物作用的靶点不完全相同,但在很大程度上遵循相同的临床研发步骤,评价要点也具有一定的相似性。本文介绍凝血因子Xa抑制剂和凝血酶(凝血因子II)抑制剂中核心药物的临床试验进程和关键的临床试验,并结合相关指导原则,探讨该类药物临床研发和评价的关键要素。The prevalence of thrombotic diseases has increasingly become a health hazard in China. The anti-coagulation therapy is the most essential treatment of thrombosis diseases. However, tbromboprophylax using anticoagulants remains a challenging issue. Exploration of new anticoagulants has been the hot point of drug research and development in recent years. Among them,the research and achievements of the factor Xa inhibitor and thrombin inhibitor are extraordinary attention-catching. The clinical research and clinical evaluation may follow general principle and similar critical path when different anticoagulants are involved. This article is aimed to discuss the crucial elements of clinical evaluation of anticoagulants by introducing the important clinical trials and related guidances.

关 键 词：抗凝血药 临床试验 临床评价 

分 类 号：R972[医药卫生—药品]