替比夫定阻断慢性乙肝病毒高载量孕妇母婴传播的临床研究

Clinical studies on telbivudine blocking mother-to-infant transmission of high load pregnant women with chronic hepatitis B virus

目的探讨替比夫定对HBV感染孕妇母婴传播的阻断作用。方法将慢性HBV感染孕妇68例分成两组,观察组34例,对照组34例。观察组孕妇自28周起口服替比夫定600 mg/d,疗程4个月,婴儿出生后6 h之内和1月时注射HBIG200 IU,并分别于0、1、6月龄注射乙肝疫苗20μg;对照组孕妇不服用任何抗病毒药物,其婴儿出生后接受与观察组同样的防疫。结果怀孕28周和产后6个月,观察组与对照组血清HBV-DNA浓度差异不明显;而分娩即刻,观察组血清HBV-DNA为(0.38±0.44)×106copies/m L,明显低于对照组(P<0.05)。观察组婴儿出生24 h、6个月和12个月后血清HBs Ag和HBV-DNA阳性率明显低于对照组(P<0.05)。出生后12个月时,观察组和对照组HBV母婴传播阻断率分别为97.06%和82.35%,差异有统计学意义(P<0.05)。结论慢性乙肝病毒高载量孕妇妊娠期应用替比夫定抗病毒治疗能明显降低母亲外周血HBV-DNA定量,阻断HBV母婴传播,且耐受性和安全性良好。

Objective To investigate the blocking effect of telbivudine on mother-to-infant transmission of Hepatitis B virus（HBV） infection in pregnant women.Methods 68 cases of pregnant women with chronic HBV infection were divided into two groups,34 cases of observation group and 34 cases of control group.Pregnant women in the observation group treated with telbivudine 600 mg / d orally since 28 weeks for 4 months.Babies were injected with200 IU HBIG after birth and one moth old,respectively,and injected with hepatitis B vaccine 20 ug in 0,1 and 6months,respectively.Pregnant women in the control group didn＇t take any antiviral drugs and babies received the same immunization as the observation group after birth.Results Serum HBV-DNA concentration of observation group and control group were not significantly difference at pregnancy of 28 weeks and 6 months after delivery.While,at delivery moment,the level of serum HBV-DNA of observation group was（0.38 ± 0.44） × 10^6 copies / m L,which was significantly lower than control group（P〈0.05）.The HBs Ag and HBV-DNA positive rate of babies in observation group was significantly lower than that of control group after born 24 h,6 months and 12 months（P〈0.05）.The blocking rate of HBV mother-to-infant transmission of observation group and control group was 97.06% and 82.35% in 12 months after birth,individually,and the difference was statistically significant（P〈0.05）.Conclusion Telbivudine antiviral therapy can significantly reduce the quantitative HBV-DNA of peripheral blood high HBV loaded pregnant mothers during pregnancy,as well as block the spread of HBV with good tolerability and safety.