国内27家浆站单采血浆捐献不良反应调查情况  

Investigation of Adverse reactions of apheresis plasma donation in 27 domestic plasma donation stations

作　　者：高阳 苏雨蒙 张宏 董德梅 GAO Yang;SU Yumeng;ZHANG Hong;DONG Demei(Beijing Tiantan Biological Products Co.,Ltd,Beijing 100000,China;Sinopharm XI′AN Biopharmaceuticals Co.,Ltd.)

机构地区：[1]北京天坛生物制品股份有限公司,北京100000 [2]国药集团西安生物制药有限公司

出　　处：《中国输血杂志》2024年第5期575-579,共5页Chinese Journal of Blood Transfusion

摘　　要：目的 探讨国内27家浆站单采血浆捐献不良反应特征及影响因素,并针对性提出预防措施。方法 选择2018-2020年全国27家浆站单采血浆捐献6 275例不良反应的献浆者记录为作为研究对象,统计发生不良反应的类型、年龄、献浆年份等相关特征并进行回顾性分析。结果 2018-2020年间全国27家采浆站单采血浆捐献不良反应发生率为1.37‰,其中血管迷走神经反应/低血容量反应(3 208例,发生率0.700‰)、枸橼酸钠过敏/低血钙症(1 205例,发生率0.263‰)、低血糖(1 020例,发生率0.223‰)、眩晕(796例,发生率0.174‰)、血肿(8例,发生率0.002‰)、其他(36例,发生率0.008‰),均为非重度不良反应,且不同类型不良反应发生率差异具有统计学意义(P<0.001);按献血浆年份比较2018、2019、2020年的不良反应,差异有统计学意义(P<0.001),其中2019年发生率最高(1.51‰,2 143/1 414 162),2020年发生率最低(1.29‰,1 818/1 410 506);不同年龄段献血浆不良反应发生率差异具有统计学意义(P<0.001),其中18~25岁发生率最高(2.61‰,224/85 733),56~60岁发生率最低(1.05‰,465/439 786);不同类型不良反应按照不同年龄段进行比较发生率,血管迷走神经反应/低血容量反应(P<0.001)、枸橼酸钠过敏/低钙血症(P<0.05)、低血糖(P<0.001)、眩晕(P<0.001)等各年龄段差异均具有统计学意义,血肿与其他不良反应不同年龄段差异无统计学意义(P>0.05)。结论 我国单采血浆捐献不良反应总体发生率偏低,其中初次、年轻(18~25岁)献浆者发生率偏高;56~60岁多次献浆者不良发生率偏低,可为我国献浆者年龄的修订提供数据支持。Objective To explore the characteristics and influencing factors of adverse reactions of apheresis plasma donation in 27 domestic plasma donation stations,and put forward targeted preventive measures.Methods A total of 6275 plasma donors with adverse reactions from 2018 to 2020 in 27 plasma donation stations in China were selected as the research objects.The types of adverse reactions,ages,time of plasma donation and other related characteristics were counted and retrospectively analyzed.Results From January 2018 to December 2020,the incidence of adverse reactions of apheresis plasma donation in 27 plasma collection stations was 1.37‰,including vasovagal reaction/hypovolemia(3208 cases,0.700‰),sodium citrate allergy/hypocalcemia(1205 cases,0.263‰),hypoglycemia(1020 cases,0.223‰),syncope(796 cases,0.174‰),hematoma(8 cases,0.002‰),other reactions(36 cases,0.008‰),all of which were non-severe adverse reactions.There were significant differences in the incidence of different types of adverse reactions(P<0.001).The adverse reactions in 2018,2019 and 2020 were compared,and the difference was statistically significant(P<0.001),with the highest incidence of 1.51‰(2143/1414162)of adverse reactions in 2019 and the lowest incidence of 1.29‰(1818/1410506)in 2020.The difference in the incidence of adverse reactions in different age groups was statistically significant(P<0.001),with the highest incidence of 2.61‰(224/85733)of 18-25 years old,and the lowest incidence of 1.05‰(465/439786)of 56-60 years old.The incidence of different types of adverse reactions was compared according to different age groups,and significant differences were noticed in the incidence of vasovagal reaction/hypovolemia(P<0.001),sodium citrate allergy/hypocalcemia(P<0.05),hypoglycemia(P<0.001),and syncope(P<0.001)among different age groups,while no significant difference was found in hematoma and other adverse reactions among different age groups(P>0.05).Conclusion The incidence of adverse reactions in plasma donation is low in Chi

关 键 词：献血浆者 献浆不良反应 年龄 单采血浆捐献 

分 类 号：R457.14[医药卫生—治疗学]