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国内27家浆站单采血浆捐献不良反应调查情况

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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。
Adverse reactions of apheresis plasma donation in 27 domestic plasma donation stations
Objective To explore the characteristics and influencing factors of adverse reactions of apheresis plasma do-nation in 27 domestic plasma donation stations,and put forward targeted preventive measures.Methods A total of 6 275 plasma donors with adverse reactions from 2018 to 2020 in 27 plasma donation stations in China were selected as the re-search 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 aphere-sis plasma donation in 27 plasma collection stations was 1.37‰,including vasovagal reaction/hypovolemia(3 208 cases,0.700‰),sodium citrate allergy/hypocalcemia(1 205 cases,0.263‰),hypoglycemia(1 020 cases,0.223‰),syncope(796 cases,0.174‰),hematoma(8 cases,0.002‰),other reactions(36 cases,0.008‰),all of which were non-se-vere 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‰(2 143/1 414 162)of adverse reactions in 2019 and the lowest incidence of 1.29‰(1 818/1 410 506)in 2020.The difference in the incidence of adverse reactions in different age groups was statistically sig-nificant(P<0.001),with the highest incidence of 2.61‰(224/85 733)of 18-25 years old,and the lowest incidence of 1.05‰(465/439 786)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 dif-ferent 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 China.In the process of plasma donation,attention should be paid to first-time and young(18-25 years old)donors.The incidence of adverse reac-tions in 56-60 years old donors is the lowest,which can provide data support for the age revision of plasma donors in China.

plasma donorsadverse reactions of plasma donationageapheresis plasma donation

高阳、苏雨蒙、张宏、董德梅

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北京天坛生物制品股份有限公司,北京 100000

国药集团西安生物制药有限公司

献血浆者 献浆不良反应 年龄 单采血浆捐献

2024

中国输血杂志
中国输血协会 中国医学科学院输血研究所

中国输血杂志

CSTPCD
影响因子:1.279
ISSN:1004-549X
年,卷(期):2024.37(5)
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