开拓创新、协同攻关,助力人血白蛋白的迭代研发及临床研究  

Driving innovation and fostering collaboration to advance the development and clinical research of nextgeneration human serum albumin

作　　者：贾继东[1] 牛俊奇[2] JIA Jidong;NIU Junqi(Liver Research Center,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Department of Hepatology,The First Hospital of Jilin University,Center of Infectious Diseases and Pathogen Biology,Changchun 130021,China)

机构地区：[1]首都医科大学附属北京友谊医院肝病中心,北京100050 [2]吉林大学第一医院肝胆胰内科,传染病与病原生物学中心,长春130021

出　　处：《临床肝胆病杂志》2025年第3期401-403,共3页Journal of Clinical Hepatology

摘　　要：白蛋白是人血浆中含量最高的蛋白质,除维持血浆胶体渗透压外,还有物质转运、解毒、维持血管完整性、抗氧化、抗炎及免疫调控等功能。在肝病领域,目前白蛋白主要用于预防大量放腹水后循环功能障碍和治疗肝硬化低白蛋白血症和腹水、自发性腹膜炎以及肝肾综合征。研发重组人血白蛋白有助于降低人血白蛋白制品的潜在生物安全风险和大量依赖进口的弊端。由于缺乏对已上市人血白蛋白关键注册临床试验结果的借鉴,人血白蛋白的临床试验设计、实施和审评均面临诸多挑战。因此需要制药企业、临床医学、方法学以及评审监管等方面的专家,求真务实、锐意创新、协同攻关。Albumin is the most abundant protein in human plasma,and in addition to the function of maintaining plasma colloid osmotic pressure,it also has the functions of material transport,detoxification,maintaining vascular integrity,antioxidation,antiinflammation,and immune modulation.In the field of liver disease,albumin is mainly used to prevent circulatory dysfunction after large-volume paracentesis and treat cirrhotic hypoalbuminemia and ascites,spontaneous bacterial peritonitis,and hepatorenal syndrome.The development of recombinant human serum albumin helps to reduce the potential biosafety risks of human serum albumin products and the disadvantages of relying heavily on import.Due to the lack of reference to the results of pivotal clinical trials of marketed human albumin products,there are still various challenges in the design,implementation,and evaluation of clinical trials of human albumin.Therefore,experts in pharmaceutical enterprises,clinical medicine,methodology,and evaluation/supervision are needed to be pragmatic,innovative and collaborative.

关 键 词：白蛋白类 重组人血白蛋白 肝硬化 临床试验 

分 类 号：R57[医药卫生—消化系统]