摘要
Abstract
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,anti-inflammation,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Key words
Albumins/Recombinant Human Serum Albumin/Liver Cirrhosis/Clinical Trial