我国单采血小板献血者献血不良反应报告发生率Meta分析

Reported incidence of adverse reactions in plateletpheresis donors in China:a meta-analysis

目的通过系统评价的方法分析我国单采血小板献血者献血不良反应的总体情况和主要影响因素,为预防和控制单采血小板献血不良反应及提高献血服务质量提供重要依据。方法检索CNKI,VIP,Wanfang Data,Pubmed、Embase数据库,收集我国单采血小板献血不良反应横断面研究,观察时间≥6个月,检索时间为1998年至2023年3月,通过2位评价员按照纳入和排除标准独立筛选研究,并进行数据提取和文献质量评价,通过Stata 14.0软件进行Meta分析。结果最终纳入91篇文献,共计单采血小板献血者585769名,其中9102名发生献血不良反应。通过随机效应模型Meta分析显示,总献血不良反应报告发生率为2.65%[95%CI(2.04,3.45),P<0.0001];亚组分析显示,东部、中部、西部地区输血不良反应报告发生率分别为2.63%[95%CI(1.94,3.58)]、2.32%[95%CI(1.29,4.16)]、4.10%[95%CI(1.90,8.83)],存在地域差异(P<0.0001)。不同献血不良反应程度报告发生率为:非重度3.62%[95%CI(2.69,4.86)]、重度0.28%[95%CI(0.18,0.45)]。在不同单采仪器之间献血不良反应报告发生率也存在差异(P<0.0001),为Amicus 2.73%[95%CI(1.23,6.06)]、CS3000系列3.59%[95%CI(2.64,4.89)]、MCS+系列3.42%[95%CI(2.23,5.25)]、Trima 4.86%[95%CI(3.08,7.66)]、其他组1.71%[95%CI(0.15,20.02)]。另外,不同性别间单采血小板献血不良反应报告发生率为女性4.80%[95%CI(3.05,7.55)]、男性为1.39%[(95%CI(0.90,2.15)],女性高于男性(P<0.0001)。≤30岁的单采血小板献血者和>30岁的单采血小板献血者之间献血不良反应分别为2.31%[95%CI(1.34,3.98)]和1.95%[95%CI(1.19,3.20)],无统计学差异(P>0.01)。在不同献血史的献血不良反应报告发生率中,首次为2.16%[(95%CI(1.18,3.95)]、再次为1.12%[(95%CI(0.35,3.58)],首次献血高于再次(P<0.0001)。不同采集治疗量之间单采献血不良反应为单份1.67%[95%CI(0.57,4.89)]、双份3.13%[95%CI(1.11,8.86)],2组间无统计学差异(P>0.01)。结论有必要统一单采血小板献血不良反应的监测标准,了解和掌握影响单采血小板献血者发生献血不良反应的因素,以提高单采血小板献血服务质量和保障献血者安全。

Objective To analyze the overall situation and main influencing factors of adverse reactions of blood donation of apheresis platelet donors in China by systematic review,and to provide basis for preventing and controlling adverse reactions of platelet donation of apheresis platelet donors and improving the quality of blood donation service.Methods CNKI,VIP,Wanfang Data,Pubmed and Embase databases were searched to collect cross-section studies on adverse reactions of platelet donation in China.The observation period was≥6 months,and the retrieval time was from 1998 to March 2023.The studies were independently screened by 2 evaluators according to the inclusion and exclusion criteria.Data extraction and literature quality evaluation were carried out,and meta analysis was performed by Stata 14.0 software.Results A total of 91 literature involving 585769 apheresis platelet donors were included,and 9102 of them had adverse reactions.Random effect model meta-analysis showed that the total incidence of adverse reactions of platelet donation was 2.65%[95%CI(2.04,3.45),P<0.0001].Subgroup analysis showed that the incidence of platelet donation adverse reactions in the eastern,central and western regions were 2.63%[95%CI(1.94,3.58)],2.32%[95%CI(1.29,4.16)]and 4.10%[95%CI(1.90,8.83)],respectively,with regional differences(P<0.0001).The incidence of adverse reactions of different degrees was 3.62%[95%CI(2.69,4.86)]for non-severe and 0.28%[95%CI(0.18,0.45)]for severe.The incidence of adverse reactions of blood donation was also different among different apheresis instruments(P<0.0001):Amicus 2.73%[95%CI(1.23,6.06)],CS3000 series 3.59%[95%CI(2.64,4.89)],MCS+series 3.42%[95%CI(2.23,5.25)],Trima 4.86%[95%CI(3.08,7.66)],other groups 1.71%[95%CI(0.15,20.02)].In addition,the incidence of adverse reactions was 4.80%[95%CI(3.05,7.55)]in females and 1.39%[95%CI(0.90,2.15)]in males,with the incidence in females higher than that in males(P<0.0001).The adverse reactions of platelet donors under 30 years old and over 30 years old were 2.31%[95%CI(1.34,3.98)]and 1.95%[95%CI(1.19,3.20)],respectively,and there was no statistically significant difference(P>0.01).The incidence of adverse reactions of blood donation for first-time donors and repeat donors was 2.16%[(95%CI(1.18,3.95)]and 1.12%[(95%CI(0.35,3.58)],with the former higher than the latter(P<0.0001).The incidence of adverse reactions for single and double platelet collection was 1.67%[95%CI(0.57,4.89)]and 3.13%[95%CI(1.11,8.86)]respectively,with no significant difference(P>0.01).Conclusion It′s suggested to unify the monitoring standards of adverse reactions of apheresis platelet donation,understand and master the factors that affect the adverse reactions of apheresis platelet donors,so as to improve the quality of apheresis platelet donation service and ensure the safety of donations.