凝血因子VIII药品综合评价  

Comprehensive Evaluation of Coagulation Factor VIII

作　　者：霍记平[1] 赵志刚[1] HUO Ji-ping, ZHAO Zhi-gang(Pharmacy department of Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing 100050, China)

机构地区：[1]首都医科大学附属北京天坛医院药学部,北京100050

出　　处：《药品评价》2018年第20期14-19,共6页Drug Evaluation

摘　　要：血友病A是凝血因子VIII缺乏引起的出血性疾病,凝血因子替代治疗是目前血友病A唯一有效的治疗措施。国内上市的替代治疗药物主要包括重组人凝血因子VIII(重组FVIII)和血源性人凝血因子VIII(血源FVIII)。本文通过检索收集国内上市的7种FVIII相关文献、药品说明书、诊疗指南、官方数据等,根据中国药品综合评价指南从药品基本信息、安全性、有效性、体内药学特性、药品质量、顺应性、经济性七方面对7种FVIII制剂进行综合评价,以期为临床合理用药提供参考。Hemophilia is an inherited hemorrhagic disease caused by the deficiency of the clotting factor VⅢ, and the clotting factor VⅢ replacement is the only effective treatment for patients with hemophilia A. Domestically listed drugs mainly include recombinant factor VⅢ （rFVⅢ） and plasma-derived factor VⅢ （pdFVⅢ）. In this paper, domestic and foreign literatures, drug instructions, diagnosis and treatment guidelines and official data of domestically listed 7 kinds of FVⅢ were collected. And a comprehensive review was made based on guideline of comprehensive evaluation for Drugs in China which included the following aspects： drug basic information, safety, efficiency, in vivo pharmaceutical characteristics, drug quality, compliance and pharmacoeconomics,in order to provide reference for rational drug use in clinical.

关 键 词：血友病A 重组FVⅢ 血源FVⅢ 药品综合评价 

分 类 号：R973[医药卫生—药品]