Abstract：
BACKGROUND: Hepatitis B virus (HBV) infection is a worldwide public health burden, especially in Asia and Africa. Concerns were raised that foetal exposure to HBV and antiretroviral therapy (ART) might suppress the innate immune response and reduce the production of hepatitis B surface antibody (HBsAb) in foetuses and infants. We therefore conducted the current study to evaluate the impact of ART on the development of the immune response to HBV in foetuses and infants.
METHODS: We selected lamivudine instead of telbivudine or tenofovir as the intervention measurement because it was the oldest and most widely used ART during pregnancy and its safety data have been sufficiently documented. A comprehensive search was conducted in eight electronic databases, including four Chinese and four English databases. Studies that met the following eligibility criteria were included: human randomized controlled trials (RCTs); participants in the treatment group were exclusively exposed to lamivudine; participants in the control group were exposed to placebo, no treatment or hepatitis B immunoglobulin; all participants were HBV-positive pregnant women with a high viral load and the main outcome of interest was neonatal HBsAb seropositivity. Data were tabulated and analysed using R software.
RESULTS: Nine RCTs were included and analysed. Compared with controls, lamivudine significantly decreased HBsAb seronegativity in the newborn within 24 h after birth (indicating the foetal immune response to HBV). Similar results were noted in infants within 6-7 months after birth and infants within 12 months (indicating the neonatal immune response to HBV vaccine).
CONCLUSIONS: Lamivudine treatment in late pregnancy boosted the foetal immune response to HBV in utero and enhanced the neonatal immune response to hepatitis B vaccine after birth.
METHODS: We selected lamivudine instead of telbivudine or tenofovir as the intervention measurement because it was the oldest and most widely used ART during pregnancy and its safety data have been sufficiently documented. A comprehensive search was conducted in eight electronic databases, including four Chinese and four English databases. Studies that met the following eligibility criteria were included: human randomized controlled trials (RCTs); participants in the treatment group were exclusively exposed to lamivudine; participants in the control group were exposed to placebo, no treatment or hepatitis B immunoglobulin; all participants were HBV-positive pregnant women with a high viral load and the main outcome of interest was neonatal HBsAb seropositivity. Data were tabulated and analysed using R software.
RESULTS: Nine RCTs were included and analysed. Compared with controls, lamivudine significantly decreased HBsAb seronegativity in the newborn within 24 h after birth (indicating the foetal immune response to HBV). Similar results were noted in infants within 6-7 months after birth and infants within 12 months (indicating the neonatal immune response to HBV vaccine).
CONCLUSIONS: Lamivudine treatment in late pregnancy boosted the foetal immune response to HBV in utero and enhanced the neonatal immune response to hepatitis B vaccine after birth.
摘要：
背景：乙型肝炎病毒（HBV）感染是全球公共卫生负担，尤其是在亚洲和非洲。人们担心胎儿暴露于HBV和抗逆转录病毒治疗（ART）可能会抑制先天免疫反应，并减少胎儿和婴儿的乙型肝炎表面抗体（HBsAb）的产生。因此，我们进行了当前的研究，以评估ART对胎儿和婴儿对HBV免疫反应发展的影响。
方法：我们选择拉米夫定代替替比夫定或替诺福韦作为干预措施，因为它是妊娠期最古老，最广泛使用的ART，其安全性数据已得到充分记录。对八个电子数据库进行了全面检索,包括四个中文和四个英文数据库。符合以下资格标准的研究包括：人类随机对照试验（RCT）;治疗组的参与者仅暴露于拉米夫定;对照组的参与者暴露于安慰剂，没有治疗或乙型肝炎免疫球蛋白;所有参与者都是HBV阳性孕妇，病毒载量高，主要结果是新生儿HBsAb血清阳性。将数据制成表格并使用R软件进行分析。
结果：纳入并分析了9个随机对照试验。与对照组相比，拉米夫定在出生后24小时内显着降低新生儿的HBsAb血清负性（表明胎儿对HBV的免疫反应）。在出生后6-7个月内的婴儿和12个月内的婴儿中也发现了类似的结果（表明新生儿对HBV疫苗的免疫反应）。
结论：妊娠晚期拉米夫定治疗可增强胎儿对宫内HBV的免疫反应，增强新生儿出生后对乙肝疫苗的免疫反应。
方法：我们选择拉米夫定代替替比夫定或替诺福韦作为干预措施，因为它是妊娠期最古老，最广泛使用的ART，其安全性数据已得到充分记录。对八个电子数据库进行了全面检索,包括四个中文和四个英文数据库。符合以下资格标准的研究包括：人类随机对照试验（RCT）;治疗组的参与者仅暴露于拉米夫定;对照组的参与者暴露于安慰剂，没有治疗或乙型肝炎免疫球蛋白;所有参与者都是HBV阳性孕妇，病毒载量高，主要结果是新生儿HBsAb血清阳性。将数据制成表格并使用R软件进行分析。
结果：纳入并分析了9个随机对照试验。与对照组相比，拉米夫定在出生后24小时内显着降低新生儿的HBsAb血清负性（表明胎儿对HBV的免疫反应）。在出生后6-7个月内的婴儿和12个月内的婴儿中也发现了类似的结果（表明新生儿对HBV疫苗的免疫反应）。
结论：妊娠晚期拉米夫定治疗可增强胎儿对宫内HBV的免疫反应，增强新生儿出生后对乙肝疫苗的免疫反应。
