乙肝免疫球蛋白联合乙肝疫苗阻断乙型肝炎母婴传播的系统评价

A systemic review on the effect of hepatitis B immunoglobulin with hepatitis B vaccines on prevention of mother-to-child transmission

目的系统评价联合乙型肝炎(以下简称乙肝)免疫球蛋白和乙型肝炎疫苗阻断乙肝表面抗原(hepatitis B surface antigen,HBs Ag)阳性母亲对其新生儿造成母婴传播的阻断效果,为新生儿乙肝预防提供理论证据。方法检索文献数据库,收集以联合免疫为主要干预措施,对HBs Ag阳性和(或)HBs Ag、乙肝e抗原(hepatitis B e antigen,HBe Ag)双阳性的慢性乙肝孕妇及其所生的新生儿进行免疫治疗的随机对照试验(randomized controlled trials,RCT),运用Revman 5.0进行Meta分析。结果共纳入6项研究,试验组426人,对照组373人。结果显示,联合乙肝疫苗和免疫球蛋白使用相比单独使用疫苗获得更佳的母婴传播阻断效果,其婴儿HBs Ag感染风险低,且差异有统计学意义(RR=0.23,95%CI:0.15~0.34,P<0.001);亚组分析显示,无论感染状态,联合疫苗干预均能在单阳性或双阳性HBs Ag感染状态的母亲中取得较好的母婴传播阻断效果(RR合并单阳=0.23,95%CI:0.07~0.71,P=0.010,RR合并双阳=0.22,95%CI:0.13~0.38,P<0.001)。结论联合使用乙肝免疫球蛋白和乙肝疫苗更能降低新生儿HBs Ag感染率。但受研究样本限制,仍需大样本和高质量的RCT试验来证实。

Objective To evaluate systematically the efficacy of using hepatitis B immunoglobulin（ HBIG） with hepatitis B vaccines on prevention of mother-to-child transmission（ MTCT） of hepatitis B virus（ HBV） occurred between HBV-positive mothers and their babies,and to provide the proof of this theory for neonatal hepatitis B prevention. Methods The databases were searched to collect randomized controlled trials（ RCTs）,which provide the statement of hepatitis B immune globulin combined hepatitis B vaccine on MTCT prevention among hepatitis B surface antigen（ HBs Ag） positive pregnant women and their babies,and meta-analysis was conducted using Rev Man 5. 0 software. Results Six trials including 426 people in the experimental group and 373 people in the control group were selected. Meta-analysis results showed that HBIG combined hepatitis B vaccine had a better efficacy on mother-to-child transmission prevention（ PMTCT） compared to hepatitis B vaccine alone with a significantly lower babies＇ HBs Ag infection risk（ RR = 0. 23,95% CI： 0. 15-0. 34,P 〈0. 001）,and subgroup analysis showed that combined vaccine interventions achieved better effect on PMTCT whether single or double-positive mothers positive infection status（ RRsingle= 0. 23,95% CI： 0. 07-0. 71,P = 0. 010,RRdouble- positive= 0. 22,95% CI： 0. 13-0. 38,P 〈0. 001）. Conclusions Compared with hepatitis B vaccine alone,HBIG combined hepatitis B vaccine can significantly reduce the neonatal HBs Ag prevalence. However,further studies are needed to verify this result using high quality,large scale and double blinded RCTs because of the sample restrictions.