拉米夫定联合乙肝免疫球蛋白阻断乙型肝炎病毒母婴传播的临床观察

目的:观察拉米夫定联合乙肝免疫球蛋白(HBIG)阻断乙型肝炎病毒(HBV)母婴传播的临床疗效和安全性。方法:124例HBV携带妊娠期妇女按随机数字表法分为观察组(58例)和对照组(66例)。对照组妊娠期妇女于产前3个月给予HBIG 200U,肌肉注射,1次/月+新生儿出生后24 h内肌肉注射乙肝疫苗1次;观察组妊娠期妇女在对照组治疗的基础上于妊娠第28周开始给予拉米夫定100 mg,口服,qd,至胎儿分娩后30 d。观察两组妊娠期妇女妊娠中期及临产前丙氨酸氨基转移酶(ALT)水平、HBV的脱氧核糖核酸(HBV-DNA)水平、新生儿HBV标志物(HBVM)及不良反应发生情况。结果:观察组妊娠期妇女治疗总有效率显著高于对照组,两组比较差异有统计学意义(P<0.05)。两组妊娠期妇女妊娠中期、临产前ALT水平比较,差异均无统计学意义(P>0.05)。两组妊娠期妇女妊娠前HBV-DNA水平比较,差异无统计学意义(P>0.05);两组妊娠期妇女妊娠中期、临产前HBV-DNA水平均显著低于同组妊娠前,且观察组低于对照组,差异均有统计学意义(P<0.05)。观察组新生儿HBV表面抗原(HBsAg)、HBV表面抗体(HBsAb)、HBV e抗原(HBeAg)、HBV e抗体(HBeAb)、HBV核心抗体(HBcAb)阳性者数均显著低于对照组,两组比较差异有统计学意义(P<0.05)。两组妊娠期妇女治疗期间均未见明显不良反应发生。结论:拉米夫定联合HBIG阻断HBV母婴传播较单用HBIG疗效更显著,且安全性较好。

Clinical Observation of Lamivudine Combined with HBIG in Blocking Mother-infant Transmission of Hep- atitis B Virus

OBJECTIVE： To observe the clinical efficacy and safety of lamivudine combined with HBIG in blocking mother-in- fant transmission of hepatitis B virus. METHODS： 124 pregnant women with HBV carrier were randomly divided into observation group （58 cases） and control group （66 cases）. Control group was given HBIG 200 U intramuscularly every month 3 months be- fore childbirth and hepatitis B vaccine intramuscularly 24 h after childbirth. Observation group was given lamivudine 100 mg oral- ly, qd, since 28th weeks of gestation, HBIG 200 U intramuscularly 30 d after childbirth and hepatitis B vaccine intramuscularly 24 h after childbirth. The levels of ALT, HBV-DNA, HBVM and ADR were observed in 2 groups during second trimester and before labor. RESULTS： Total effective rate of observation group was significantly higher than that of control group; there was statistical significance （P〈0.05）. There was no statistical significance in the level of ALT between 2 groups during second trimester and be- fore labor （P〉0.05）. There was no statistical significance in the level of HBV-DNA between 2 groups before pregnancy （P〉 0.05）. The level of HBV-DNA in observation group during second trimester and before labor was significantly lower than before pregnancy; there was statistical significance （P〈0.05） ; there was no statistical significance in the level of HBV-DNA in control group before pregnancy, during second trimester and before labor （P〉0.05）. The positive anti-HBc and anti-HBe of newborns in observation group were significantly lower than in control group; there was statistical significance （P〈0.05）. No significant ADR was found in 2 groups during treatment. CONCLUSIONS： Lamivudine combined with HBIG is more effective and safer than HBIG alone in blocking mother-infant transmission of hepatitis B virus.