Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing Youan Hospital, Capital Medical University, Beijing, China.
Beijing Municipal Key Laboratory of Liver Failure and Artificial Liver Treatment Research, Beijing, China.
J Viral Hepat. 2019 Sep;26(9):1059-1065. doi: 10.1111/jvh.13123. Epub 2019 Jun 3.
The aim of this study was to investigate the efficacy of antepartum administration of three doses of hepatitis B immunoglobulin (HBIG) in interrupting mother-to-child transmission (MTCT) of hepatitis B virus (HBV). In this trial, a total of 728 HBeAg-positive pregnant women with chronic HBV infection who had an HBV DNA level higher than 6log copies/mL were enrolled. They were divided into three groups based on individual preference. Subjects in group A and group B received 200 IU (unit) HBIG and 400 IU (unit) HBIG intramuscularly once a month at the third, second and first month before delivery, respectively. Subjects in the control group (C) received no special treatment. All the infants received passive-active immunoprophylaxis. The HBsAg-positive rate of all infants at 7-12 months of age was 5.1% (37/728). Specifically, the HBsAg-positive rate of infants was comparable in all three groups (5.3% vs 5.1% vs 5%, P = 0.988). No significant difference was found in anti-HBs levels between the infants aged 7-12 months in the three groups (P = 0.469). HBV DNA levels of the umbilical cord blood in the HBV-infected group were higher than those in the uninfected group (5.2 vs 3.4log copies/mL, P < 0.001), and these with family history of HBV infection were also higher (45.9% vs 28.5%, P = 0.034). To conclude, administration of passive-active immunoprophylaxis to infants contributed to effective prevention of the MTCT of HBV; extra antepartum administration of HBIG during pregnancy could not decrease the rate of MTCT or increase the anti-HBs levels of infants born to HBsAg-positive mothers with HBV DNA higher than 6log copies/mL.
本研究旨在探讨产前给予三剂乙型肝炎免疫球蛋白(HBIG)在阻断乙型肝炎病毒(HBV)母婴传播(MTCT)方面的疗效。在这项试验中,共纳入 728 例 HBeAg 阳性的慢性 HBV 感染孕妇,其 HBV DNA 水平高于 6log 拷贝/ml。他们根据个人意愿分为三组。A 组和 B 组受试者分别于分娩前第三个月、第二个月和第一个月每月接受 200IU(单位)HBIG 和 400IU(单位)HBIG 肌内注射。对照组(C 组)不接受特殊治疗。所有婴儿均接受被动-主动免疫预防。所有婴儿在 7-12 个月龄时 HBsAg 阳性率为 5.1%(37/728)。具体而言,三组婴儿的 HBsAg 阳性率相似(5.3%比 5.1%比 5%,P=0.988)。三组 7-12 个月龄婴儿的抗-HBs 水平无显著差异(P=0.469)。HBV 感染组脐带血 HBV DNA 水平高于未感染组(5.2 比 3.4log 拷贝/ml,P<0.001),有 HBV 感染家族史者也较高(45.9%比 28.5%,P=0.034)。总之,为婴儿提供被动-主动免疫预防有助于有效预防 HBV 的 MTCT;在 HBV DNA 高于 6log 拷贝/ml 的 HBsAg 阳性母亲怀孕期间额外给予 HBIG 产前治疗并不能降低 MTCT 率或增加婴儿的抗-HBs 水平。