三种补液方式预防即发型及迟发型献血相关血管迷走神经反应的效果研究:基于群组随机试验  

Effects of three rehydration methods on prevention of on-site and delayed blood donation-related vasovagal responses:a cluster-randomized trial

作　　者：谢桂芸 黎世杰[1] 欧阳剑[1] 冯凡凡 郑晓晓[1] 周芷羽 麦连芳 陈锦艳[1] XIE Guiyun;LI Shijie;OUYANG Jian;FENG Fanfan;ZHENG Xiaoxiao;ZHOU Zhiyu;MAI Lianfang;CHEN Jinyan(Guangzhou Medical Key Laboratory,Guangzhou Blood Center,Guangzhou 510080,China)

机构地区：[1]广州血液中心广州市血液安全重点实验室,广东广州510080

出　　处：《中国输血杂志》2024年第1期43-50,共8页Chinese Journal of Blood Transfusion

基　　金：广州市科技计划项目(2023A03J1003);广州市医学重点学科(2021-2023年)。

摘　　要：目的对比3种献血前补液方式对预防即发型及迟发型献血相关血管迷走神经反应(vasovagal response,VVR)的效果。方法2021年1—6月,在本中心6个固定献血点对符合献血条件,签署知情同意的6250名全血献血者,按献血点和日期分为198个群组,按随机数法随机分配到口服补液盐(ORS)组,糖水组或饮用水组,分别在献血前20 min内喝完500 mL饮用水,糖水及ORS,研究人员现场记录干预的实际完成情况,并登记现场发生的VVR及相关情况。献血后休息时,献血者完成包含社会人口学信息的电子问卷。献血后48 h,研究人员电话回访每位献血者,登记迟发型VVR及相关情况。基于意向性分析法(ITT)Logistic回归分析3组间VVR发生率差异,考虑到依从性的影响,计算干预组的平均处理效应(ATT)。用PASS 2021估算样本量,R(4.2.0)做统计分析。结果本中心固定点全血献血者在3种不同的献血前补液方式干预下,献血相关VVR的累计发生率为2.67%(2.29%~3.11%),其中,即发型和迟发型VVR的发生率分别为1.02%(0.79%~1.31%)和1.65%(1.36%~2.01%)。ITT分析仅发现ORS比水组可有效降低迟发型VVR发生率【OR=0.59,95%CI[0.37,0.94]】。ATT分析考虑了依从性的影响发现:任意两组间即发型VVR发生率差异均无统计学意义(P>0.05);糖水组对比饮用水组的迟发型VVR发生率差异无统计学意义(P>0.05)。补充ORS对比饮用水,迟发型VVR发生率平均下降值相差了-0.013,95%CI[-0.022,-0.004],补充ORS对比糖水,迟发型VVR发生率平均下降值相差了-0.008,95%CI[-0.017,-0.000],差异均有统计学意义(P<0.05)。3个组累计VVR显示了与迟发型VVR相似的结果。结论献血前补充ORS对预防迟发型VVR效果最好,下一步可建立迟发型VVR预测模型甄别易感人群,建议其献血前喝ORS,其他人群献血前可根据喜好任选液体,实现献血相关VVR的个性化防控。Objective To compare the effects of 3 rehydration methods before blood donation on the prevention of on-site and delayed blood donation-related vasovagal response(VVR).Methods From January to June 2021,6250 whole blood donors in 6 fixed blood donation sites signed informed consent and were divided into 198 clusters according to donor sites and dates,then they were randomly assigned to receive either oral rehydration salts(ORS),sugar water,or water group,and each drank 500 mL of ORS,sugar water or water within 20 minutes before blood donation.The researchers recorded the actual intervention accepted on site,and recorded the immediate VVR and related information.At rest after blood donation,donors submitted an electronic questionnaire containing socio-demographic information.At 48 hours after blood donation,the researchers called back every donor to record delayed VVR and related information.Logistic regression based on intention to treat(ITT)was used to analyze the difference of the incidence of VVR among the three groups,and the average treatment effect on treated(ATT)was calculated.PASS 2021was used to estimate the sample size and R(4.2.0)for statistical analysis.Results The cumulative incidence of blood donation-related VVR was 2.67%(2.29%-3.11%)among street whole blood donors under the 3 rehydration methods,in which,the incidence of immediate and delayed VVR was 1.02%(0.79%-1.31%)and 1.65%(1.36%-2.01%)respectively.ITT analysis found that ORS were more effective than water in reducing the incidence of delayed VVR【OR=0.59,95%CI[0.37,0.94]】.There was no significant difference in the incidence of immediate VVR between any two groups(P>0.05),and there was no significant difference in the incidence of delayed VVR in the sugar water group compared with the water group(P>0.05).There was a difference of-0.013【95%CI[-0.022,-0.004]】or-0.008【95%CI[-0.017,-0.000]】in the incidence of delayed VVR in the ORS group compared with water group or sugar water group,the difference was significant(P<0.05).The cumulative

关 键 词：献血相关血管迷走神经反应 群组随机试验 逻辑回归 平均处理效应(ATT) 

分 类 号：R457.1[医药卫生—治疗学]