首都医科大学附属北京友谊医院肝病中心;吉林大学第一医院肝胆胰内科,传染病与病原生物学中心;
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。
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基本信息:
DOI：
中图分类号:R977
引用信息:
[1]贾继东,牛俊奇.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[J].临床肝胆病杂志,2025,41(03):401-403.
基金信息: