RhD主动免疫安全性研究  

Safety of RhD alloimmunization

作　　者：李晨越 陈思恬 何芮 宋宁[1] 田力 张进进[3] 黄永莉 邢颜超[3] 刘忠[1] LI Chenyue;CHEN Sitian;HE Rui;SONG Ning;TIAN Li;ZHANG Jinjin;HUANG Yongli;XING Yanchao;LIU Zhong(Institute of Blood Transfusion,Chinese Academy of Medical Sciences&Peking Union Medical College,Key Laboratory of Transfusion Adverse Reactionsof Chinese Academy of Medical Sciences,Chengdu 610052,China;Hunan Children's Hospital;General Hospital of Xinjiang Military Region)

机构地区：[1]中国医学科学院北京协和医学院输血研究所中国医学科学院输血不良反应研究重点实验室,四川成都610052 [2]湖南省儿童医院 [3]新疆军区总医院

出　　处：《中国输血杂志》2021年第5期489-493,共5页Chinese Journal of Blood Transfusion

摘　　要：目的探讨使用RhD阳性红细胞主动免疫RhD阴性者过程的安全性,为国产抗-D免疫球蛋白开发助力。方法在2018年1月~2020年4月纳入23名知情同意的RhD阴性志愿者,研究由初始免疫(初免)及加强免疫组成,初免包括首次初免,二次初免以及三次初免。首次初免分为20 mL 3人、30 mL 8人、40 mL 6人和50 mL 6人4组,初始免疫产生应答后各组每3个月行加强免疫1次,根据每次免疫前抗-D效价,将加强免疫剂量分为0.5、1、2 mL;每次输注后24 h、1周,采集志愿者全血标本5 mL/人(次),检测其血常规、肝肾、凝血功能与抗-D效价。比较各(剂量)组首次初免后,24 h及1周各检测(指标)值之间的差异;比较各(剂量)组加强免疫后,24 h及1周各检测(指标)值与免疫应答前差值之间的差异。结果RhD阳性红细胞(mL/人)20、30、40和50各(剂量)组首次初免后,各溶血指标值均在医学参考值范围内且24 h和1周的各溶血指标值之间无明显变化(P>0.05);每次各剂量组加强免疫输注RhD阳性红细胞0.5或1 mL/人后24 h和1周的溶血指标值与免疫应答前基础值(均在医学参考值范围内)的差值之间无明显变化(P>0.05),输注RhD阳性红细胞2 mL/人后,24 h和1周的Tbil值(μmol/L)与免疫应答前基础值的差值之间(1.55±1.87,6.29±2.66)有明显变化(P<0.05)。结论本实验制定的主动免疫程序未发现影响RhD阴性者安全的现象。Objective To explore the safety of RhD-positive red blood cells(RBCs)immunization schedules in RhD-negative volunteers,so as to facilitate the development of domestic anti-D immunoglobulin.Methods From January 2018 to April 2020,23 RhD negative volunteers with informed consent were enrolled and divided into initial immunization group and booster immunization group.The initial immunization included first immunization,second immunization and third immunization.Four groups,i.e.3 cases of 20 mL,8 of 30 mL,6 of 40 mL,and 6 of 50 mL,were involved in initial immunization.After the initial immunization response,booster immunizations were performed every 3 months.According to the anti-D titer before each immunization,the booster immunization doses were set to 0.5,1 and 2 mL.Whole blood samples of 5 mL/person(time)were collected 24 h and 1 week after each infusion,and the blood routine,liver,kidney and blood coagulation function and anti-D titer were detected.The differences of detection(index)values at 24 h and 1 week after the first immunization and booster immunization in each(dose)group were compared.Results No statistically significant differences were observed in hemolysis index values(all within the range of medical reference values)24 h or 1 week after initial immunization among RhD positive RBCs of 20,30,40 and 50 mL(P>0.05).The differences between the hemolysis index values and the basic values before the immune response(all within the range of medical reference values)after 0.5 or 1 mL booster immunizations were also not statistically different(P>0.05).However,the differences(μmol/L)between total bilirubin levels and the basic values before the immune response(1.55±1.87,6.29±2.66)were significantly different after 2 mL booster immunization(P<0.05).Conclusion No risks affecting the safety of RhD negative volunteers was found in the immunization schedule proposed in this study.

关 键 词：RHD阴性 RhD阳性红细胞输血 主动免疫 抗-D免疫球蛋白 胎儿和新生儿溶血性疾病 血液安全 

分 类 号：R446.62[医药卫生—诊断学] R392.1[医药卫生—临床医学]