真实世界人血白蛋白用于心外科围术期有效性和安全性研究  

A real-world study on the efficacy and safety of human serum albumin used in the perioperative period of cardiac surgery

作　　者：刘东华[1] 王路平[1] 李红[1] 纪洪艳 邢晓敏[1] 王心怡 李静[1] LIU Donghua;WANG Luping;LI Hong;JI Hongyan;XING Xiaomin;WANG Xinyi;LI Jing(Department of Pharmacy,the Affiliated Hospital of Qingdao University,Shandong Qingdao 266000,China)

机构地区：[1]青岛大学附属医院药学部,山东青岛266000

出　　处：《中国医院药学杂志》2025年第7期799-803,共5页Chinese Journal of Hospital Pharmacy

基　　金：山东省第二批药品临床综合评价项目(编号:2022YZ014);吴阶平医学基金会科研专项资助基金(编号:320.6750.2024-06-41)。

摘　　要：目的:评估人血白蛋白用于心外科围术期患者的有效性和安全性差异,以期为临床医生进行临床决策时提供数据支持和参考。方法:回顾性收集2021年1月至2023年6月青岛大学附属医院择期行心脏手术围术期使用人血白蛋白患者的真实世界数据,将患者分为进口人血白蛋白组(贝林)和国产人血白蛋白组(泰邦),比较2组的有效性和安全性。结果:接受体外心肺循环(cardio pulmonary bypass,CPB)的患者,贝林组和泰邦组的相关结局指标和对血制品的需求量差异均无统计学意义(P>0.05)。非CPB患者,2组患者的住院时间、术后30 d死亡率、术后60 d死亡率、术后引流总量、有创呼吸机使用时间、血浆使用量、红细胞使用量差异无统计学意义(P>0.05),但与进口贝林组相比,国产泰邦组患者的ICU时间和术后引流时间更长(P<0.05)。2组安全性指标差异无统计学意义(P>0.05)。结论:CPB患者,国产人血白蛋白(泰邦)用于围术期的有效性和安全性与进口人血白蛋白(贝林)相似;非CPB患者,进口贝林组的ICU时间和引流时间这两项指标要优于国产泰邦组,其他7项有效性结局指标相似,2组安全性无明显差异。OBJECTIVE To evaluate the efficacy and safety of human serum albumin(HSA)on the perioperative period of cardiac surgery,thus providing support and references for making clinical decisions.METHODS A retrospective collection of real-world data was conducted on patients who underwent elective cardiac surgery and were given to HSA during the perioperative period in the Affiliated Hospital of Qingdao University from January 2021 to June 2023.Patients were divided into the imported HAS group(Beilin)and the domestically produced HAS group(Taibang).The efficacy and safety of the two groups were compared.RESULTS There were no significant differences in the relevant outcome indicators and demand for blood products between Beilin group and Taibang group of cardio pulmonary bypass(CPB)patients(P>0.05).There were no significant differences in the length of stay,30-day mortality rate,60-day mortality rate,postoperative total tube drainage,duration of invasive ventilation,amount of plasma transfusion,and amount of red blood cell transfusion between the two groups of non-CPB patients(P>0.05).However,compared with the Beilin group,the length in intensive care unit(ICU)and postoperative drainage time of the Taibang group were significantly longer(P<0.05).There was no significant difference in the safety between the two groups(P>0.05).CONCLUSION For CPB patients,the efficacy and safety of domestically produced HSA(Taibang)are similar to those of imported HSA(Beilin).In-non CPB patients,the length in ICU and drainage time of the imported HAS(Beilin)are shorter than those of giving domestic HSA(Taibang),presenting similar manifestations in the other 7 outcome indicators.Safety profile is comparable between the two groups.

关 键 词：心外科围术期 人血白蛋白 有效性 安全性 

分 类 号：R973.4[医药卫生—药品]