关键词: 血液安全监测, 献血不良反应, 报告发生率, 危险因素

Abstract: Objective To characterize the hemovigilance work in Fujian Blood Center, to analyze and summarize the characteristics of donors with adverse reactions and the risk factors of adverse donor reactions in hemovigilance process of the center, and to provide data support and scientific basis for effective sentinel surveillance and improvement work to ensure the safety of blood donors. Methods From 2019 to 2021, 238 894 donors with adverse reactions in Fuzhou were enrolled as study subjects to compare the reported incidence and basic information of donors with adverse reactions and the types of adverse reactions in three years. All whole blood donors in 2021 were recruited to analyze the time of occurrence and causative factors of adverse donor reactions, and to conduct multiple logistic regression analysis of risk factors for adverse reactions in donors. Results A total of 8 248 adverse events were reported among 238 894 blood donors in three years, with an overall reported incidence of 3.45% (8 248/238 894) and 98.46% (8 125/8 252) of donation related vasovagal reaction (DRVR) in total adverse donor reactions. The reported incidence of adverse donor reactions was higher in women (4.17%) than in men (2.92%), and higher for the first time (5.38%) than for the second time (1.58%). It was elevated in those who donated at blood donation vehicles (4.39%) compared to medical cabins/warehouses (2.02%) or stations (1.39%). Also, university groups (6.93%) reported higher incidence of adverse reactions than social groups (1.90%) and individuals (1.85%). By analyzing the 3 195 cases of adverse donor reactions reported in 2021, we found that the adverse reactions mainly occurred at the "time of donation", accounting for 70.86% (2 264/3 195), and their primary causative factors were fasting (21.03%), fatigue (19.98%) and stress (12.92%). Multiple logistic regression analysis showed that low age (18~22), first-time blood donation, donation at vehicles or by hospital mobilization were risk factors for adverse reactions. Conclusion The reporting criteria, data collection methods, feedback channels and the proportion of group donors in universities will directly affect the reported incidence of donor adverse reactions. In Fuzhou, adverse donor reactions were mainly DRVRs, mostly due to fasting, stress and fatigue. Low age, first time donation, donation vehicle environment, and donation by hospital mobilization were risk factors for adverse donor reactions.

Key words: Hemovigilance, Adverse donor reactions, Incidence, Risk factors