妊娠中后期口服替诺福韦联合主被动免疫对乙型肝炎病毒母婴传播的阻断效果和安全性

Efficacy and safety of oral administration of tenofovir combined with active and passive-immunization in mid and late pregnancy in blocking mother-to-child transmission of hepatitis B virus

目的:探讨妊娠中后期口服替诺福韦联合主被动联合免疫治疗对乙型肝炎病毒(HBV)母婴传播的疗效和安全性。方法:纳入2017年1月至2019年6月在南通大学附属海安医院产科就诊并分娩的HBV感染孕妇86例,随机分为观察组和对照组,对照组孕产妇给予常规保肝治疗,观察组孕产妇在对照组治疗基础上加用替诺福韦口服治疗,两组新生儿均给予主被动联合免疫阻断治疗,观察两组孕产妇的肝肾功能指标变化、妊娠结局和婴儿生理指标。结果:治疗前两组孕产妇的HBV DNA、ALT、TC和Cys C水平比较无差异(P>0.05);产前1天和产后3个月时观察组孕产妇HBV DNA和ALT均低于对照组(P<0.05),TC和Cys C水平变化无差异(P>0.05)。两组孕产妇的早产、剖宫产、新生儿窒息、产后出血和新生儿黄疸等指标无差异(P>0.05)。产后1个月时,两组新生儿的身高和体重无差异(P>0.05),观察组新生儿HBsAg阳性率、HBeAg阳性率和HBV DNA≥100 IU/mL发生率低于对照组(P<0.05)。结论:在HBV感染孕妇妊娠中后期给予替诺福韦口服联合主被动联合免疫治疗,能有效阻断HBV的母婴垂直传播,用药安全性较高。

Objective:To investigate the efficacy and safety of oral tenofovir combined with active and passive immunotherapy in mother-to-child transmission of HBV.Methods:From January 2017 to June 2019,86 cases of HBV infection in pregnant women were randomly divided into observation group and control group, control group given conventional treatment, protect liver observation group on the basis of treatment with oral tenofovir, newborn two group were given the passive joint immune blocking treatment, observation of the two groups of maternal liver and kidney function index changes, pregnancy outcomes and infant physiological index. Results:There was no difference in HBV DNA, ALT, TC and Cys C levels between the two groups before treatment(P>0.05). HBV DNA and ALT levels in the observation group were lower than those in the control group at 1 day before and 3 months after the birth(P<0.05), and there was no difference in TC and Cys C levels(P>0.05). There was no difference in the indicators of preterm delivery, cesarean section, neonatal asphyxia, postpartum hemorrhage and neonatal jaundice between the two groups(P>0.05). At 1 month postpartum, there was no difference in height and weight between the two groups(P>0.05), and the HBsAg positive rate, HBeAg positive rate and HBV DNA≥100 IU/mL incidence in the observation group were lower than those in the control group(P<0.05). Conclusion:Oral administration of tenofovir combined with active and passive immunotherapy in the middle and late pregnancy of HBV-infected pregnant women can effectively block mother-to-child vertical transmission of HBV with high drug safety.