人血白蛋白注射液的药品评价研究进展  

Research progress in human serum albumin injections

作　　者：鲁松 杨萍 杨黎 董宪喆 张兰[1,2] LU Song;YANG Ping;YANG Li;DONG Xianzhe;ZHANG Lan(Department of Pharmacy,Xuanwu Hospital,Capital Medical University,Beijing 100053,China;College of Pharmacy,Zunyi Medical University,Zunyi Guizhou 563000,China)

机构地区：[1]首都医科大学宣武医院药学部,北京100053 [2]遵义医科大学药学院,贵州遵义563000

出　　处：《中国药物警戒》2022年第2期228-232,共5页Chinese Journal of Pharmacovigilance

基　　金：重大新药创制国家科技重大专项2017年度(2017ZX09101001-002-044);首都科技领军人才培养工程项目(Z191100006119017)。

摘　　要：依据《中国药品综合评价指南参考大纲》对人血白蛋白(human serum albumin, HSA)注射液进行药品评价。查阅HSA注射液相关的诊疗指南、药典、药品说明书、文献及官方数据,对其安全性、有效性、顺应性、经济性等进行描述性分析。HSA注射液临床应用广泛且安全性好,但价格偏贵,医保仅限抢救、重症或因肝硬化、癌症引起胸腹水的患者(HSA低于30 g·L^(-1));HSA注射液已被多个国家的指南推荐用于肝硬化腹水、低血容量休克等疾病的治疗,但临床仍有不合理用药的情况发生。Human serum albumin(HSA) injections based on the “Guidelines for Comprehensive Evaluation of Chinese Drugs”were evaluated. The guidelines for diagnosis and treatment, pharmacopoeias, drug inserts, literature and official data related to HSA injections were consulted, while the safety, efficacy, compliance, cost, and clinical value of HSA were assessed. HSA injections are widely used in clinical practice and are quite safe, but they are too expensive and have not yet entered the national medical insurance catalogue. HSA injections have been recommended by guidelines in many countries for the treatment of such diseases as liver cirrhosis and hypovolemic shock, but there are still cases of inappropriate medication.

关 键 词：人血白蛋白注射液 药品评价 合理用药 药品不良反应 

分 类 号：R994.11[医药卫生—毒理学]