新生儿出生后两次乙肝免疫球蛋白注射不提高HBV母婴传播阻断效果  

Efficacy of two injections of hepatitis B immunoglobulin in infants to interrupt mother-to-children transmission of hepatitis B virus

作　　者：张英[1] 易为[2] 李明慧[3] 张丹[3] 张禄雪[3] 胡玉红[2] 刘敏[2] 刘顺爱[5] 华文浩[4] 宋淑静[4] 万钢[6] 谢尧[1] 

机构地区：[1]北京大学地坛医院教学医院,100015 [2]首都医科大学附属北京地坛医院妇产科 [3]首都医科大学附属北京地坛医院肝病中心肝病二科 [4]首都医科大学附属北京地坛医院检验科 [5]首都医科大学附属北京地坛医院传染病研究所 [6]首都医科大学附属北京地坛医院病案科

出　　处：《中华实验和临床病毒学杂志》2017年第2期142-147,共6页Chinese Journal of Experimental and Clinical Virology

基　　金：北京市卫生系统高层次卫生人才项目（2015-3-106）;北京市科技计划课题“首都医学特色”项目（Z151100004015122）;北京市科学技术委员会重大项目（D121100003912001）

摘　　要：目的 观察在标准免疫预防HBIG＋乙肝疫苗（0、1、6）的基础上,于出生后1个月再次注射HBIG 200 IU 1次对提高HBV母婴阻断效果的作用.方法 入组HBsAg与HBeAg阳性、HBV DNA≥1.0＆#215;106 IU/ml且妊娠期间未使用抗乙肝病毒药物的慢性HBV感染孕妇及其所生新生儿.新生儿被随机分配到对照组和实验组,对照组新生儿给予标准HBV预防免疫接种方案：200 IU HBIG＋10 μg重组乙型肝炎疫苗（0、1、6个月）,实验组：在标准预防的基础上于新生儿出生后1个月时再次注射200 IU HBIG.并于出生时和出生后7个月检测静脉血中HBsAg、抗HBs、HBV DNA.新生儿出生后7个月血清 HBsAg和/或HBV DNA阳性定义为HBV母婴阻断失败.结果 本研究共入组280例新生儿,后期随访过程中失访14例（实验组6例,对照组8例）,最终完成随访266例（实验组134例,对照组132例）,本研究对完成随访的人数进行统计分析.实验组和对照组母亲产前HBV DNA载量分别为7.31＆#177;0.66 log10IU/ml和7.32＆#177;0.74 log10IU/ml（t=0.11,P=0.92）;实验组和对照组HBV阻断失败率分别为5.97%（8/134）和7.58%（10/132）,差异无统计学意义（P=0.63）;实验组新生儿的抗HBs阳性（≥10 mIU/ml）率及其水平分别为94.03%和（623.60＆#177;412.93 mIU/ml）,与对照组的抗HBs阳性率（91.67%）及水平（620.38＆#177;399.10 mIU/ml）差异无统计学意义（P=0.48, P=0.95）.18例阻断失败新生儿母亲分娩前HBV DNA载量（7.58＆#177;0.62 log10IU/ml）高于248例阻断成功组（7.29＆#177;0.70 log10IU/ml）（P=0.09）;阻断失败新生儿出生时静脉血HBsAg阳性百分率和HBV DNA阳性率均为100%,显著高于阻断成功新生儿HBsAg阳性率（35.89%）和HBV DNA阳性率（31.85%）（P ＜0.001）.Logistic回归分析显示,新生儿静脉血中 HBsAg阳性为乙肝病毒母婴阻断失败的独立相关因素（OR 1.39 95%CI 1.14~1.68）.分层分析结果显示, 新生儿静脉血HBsAg在0.05-〈 1、 1-Objective To investigate the efficacy of 200IU hepatitis B immunoglobulin （HBIG） injection at 1 month after birth to interrupt the mother-to-children transmission （MTCT） of hepatitis B virus （HBV）.Methods Infants born to mothers who were hepatitis B surface antigen （HBsAg） and hepatitis B e antigen （HBeAg） positive, with HBV DNA load ≥1.0＆#215;106 IU/ml and who did not receive antiviral drug treatment during pregnancy, were randomly divided into 2 groups.Infants in the control group were treated with standard immunoprophylaxis： 200 IU HBIG and 10 μg recombinant hepatitis B vaccine injection within 2 h after birth and a vaccine booster at 1 and 6 months after birth.For infants in the HBIG group the standard immunoprophylaxis and an additional 200 IU HBIG were administered at 1 month.HBsAg, the antibody to HBsAg （anti-HBs）, and HBV DNA load were measured at birth and after 7 months.later.Immunoprophylaxis failure was defined as the presence of HBV DNA and HBsAg positivity or the presence of HBV DNA and HBsAg negativity at 7 months.Results In this prospective cohort study, of the 280 infants enrolled, 14 infants （HBIG/control： 6/8） were lost to follow-up and 266 subjects （HBIG/control： 134/132） completed the 7-month study.The log10 HBV DNA load of mothers in the HBIG group and control group were （7.31＆#177;0.66） log10IU/ml and （7.32＆#177;0.74） log10IU/ml, respectively （P=0.92）.The MTCT rate of the two groups was similar （5.97% vs.7.58%, P=0.63）.At 7 months, the HBsAg positive rate and the level of anti-HBs in the two groups were 94.03%（126/134）vs.91.67% （121/132） and 623.60＆#177;412.93 mIU/mL vs.620.38＆#177;399.10 mIU/ml, respectively with no significant difference （P=0.48 and P=0.95, respectively）.The log10 HBV DNA load of mothers in immunoprophylaxis failure group and success group was similar （P=0.09）.The number of infants who were serum HBsAg positive and HBV DNA positive at birth in the immunoprophylaxis failure group were higher

关 键 词：乙肝免疫球蛋白 肝炎病毒 乙型 乙肝疫苗 母婴传播 

分 类 号：R722.1[医药卫生—儿科]