妊娠中晚期使用替诺福韦阻断HBV母婴传播的临床效果及安全性分析

Efficacy and safety of tenofovir on blocking HBV vertical transmission in middle-late pregnancy

目的探讨替诺福韦用于妊娠中晚期HBV高载量孕妇,观察其对母婴阻断的效果及其安全性。方法 96例HBV高载量孕妇按个人意愿分为观察组(60例)和对照组(36例),对照组不给予抗病毒治疗,观察组于妊娠24~28周给予替诺福韦口服至分娩时,两组新生儿出生后均予标准免疫预防(乙肝免疫球蛋白+乙肝疫苗),比较两组孕妇HBV-DNA水平变化、婴儿7月龄时HBsAg、HBV-DNA阳性率、新生儿出生时的生长发育情况及围生期不良事件发生率,观察孕妇用药后发生相关不良反应情况。结果治疗前,观察组和对照组患者血清HBV-DNA水平分别为(7.59±1.21)log_(10)IU/mL和(7.57±1.23)log_(10)IU/mL,差异无统计学意义(P>0.05);分娩前,观察组孕妇的血清HBV-DNA水平[(3.25±0.61)log_(10)IU/mL]显著下降并明显低于对照组[(7.65±1.29)log_(10)IU/mL],差异有统计学意义(P<0.05)。分娩7个月后,观察组婴儿血清HBsAg、HBV-DNA阳性率均为0%,母婴阻断率达100%,对照组婴儿血清HBsAg、HBV-DNA阳性率分别为13.9%、11.1%,母婴阻断率为86.1%,两组差异有统计学意义(P<0.05)。两组新生儿出生时的身长、头围、体质量、Apgar评分及围生期不良事件发生率均无明显差异(P>0.05)。观察组孕妇用药后发生相关不良反应者有3例,其中2例表现出轻微头晕、乏力,1例表现轻度恶心、纳差,发生率为5.0%。结论妊娠中晚期使用替诺福韦可有效阻断HBV母婴传播,安全性好。

Objective To investigate the efficacy and safety of tenofovir on blocking HBV vertical transmission in middle-late pregnancy. Methods A total of 96 hepatitis B virus high load pregnant women were divided into the observation group（60 cases） and the control group（36 cases） according to their individual will. The patients in the observation groupreceived tenofovir from pregnant 24-28 weeks until the end of pregnancy. The two groups of newborns were given standard immunoprophylaxis（HBV immunoglobulin ＋ hepatitis B vaccine） after birth. The changes in HBV-DNA level, the positive rate of HBV surface antigen（HBsAg） and HBV-DNA at 7 months of age, the growth and development of newborn babies and the incidence of perinatal adverse events were compared in the two groups, and the adverse reaction of pregnant women after drug use was observed. Results Before the treatment, the serum HBV-DNA level of the observation group was（7.59±1.21） log（10） IU/mL versus（7.57±1.23） log（10） IU/mL of the control group（P〈0.05）. Before the delivery, the serum HBV-DNA level of the observation group was（3.25±0.61） log（10） IU/mL versus（7.65±1.29） log（10） IU/mL of the control group（P〈0.05）. For those of 7-month-old infants, the positive rates of HBsAg and HBV-DNA in the observation group were both 0% with the blocking rate of mother-to-child transmission of HBV of 100%, which were significantly lower than 13.9% and 11.1% in the control group with the blocking rate of mother-to-child transmission of HBV of 86.1%（P〈0.05）. There were no significant differences in birth length, head circumference, body weight, Apgar score and incidence of adverse events during the perinatal period between the two groups（P〉0.05）. In the observation group, there were 3 cases of related adverse reactions after use of tenofovir, of which 2 cases showed slight dizziness and fatigue, 1 case showed mild nausea and anorexia, and the incidence was 5.0%. Conclusion The blocking efficacy of tenofovir on HBV vertical transmission in middle-late pregnancy is very well, so is the safety.