拉米夫定与替比夫定阻断乙型肝炎病毒宫内感染的疗效和风险分析

Efficacy and risk analysis of lamivudine and telbivudine in blockingmother-to-child intrauterine infection of hepatitis B virus

目的分析应用拉米夫定和替比夫定阻断乙型肝炎病毒(HBV)宫内感染的疗效和风险。方法2014年6月~2018年6月在我院肝病科和妇产科就诊的慢性HBV携带孕妇120例,在孕28周时,其中40例接受拉米夫定,40例接受替比夫定治疗,分娩后立即停止抗病毒治疗,另20例在孕期未接受抗病毒治疗。新生儿出生后按计划接受标准的乙肝疫苗和乙型肝炎免疫球蛋白注射,随访1年。采用实时荧光定量PCR法检测血清HBV DNA,采用电化学发光法检测血清HBsAg和HBsAb。结果入组时,三组孕妇血清HBV DNA水平无统计学差异(P>0.05);分娩时,接受拉米夫定和替比夫定治疗的孕妇血清HBV DNA转阴,显著低于对照组【(7.6±1.5)lg copies/ml,P<0.05】,在分娩后3个月,两组抗病毒治疗的孕妇血清HBV DNA水平再次回到治疗前水平,与对照组比,无显著性差异(P<0.05);在出生时,40例拉米夫定治疗、40例替比夫定治疗和21例未接受抗病毒治疗孕妇所生的新生儿血清HBsAg阳性率分别为5.0%、5.0%和9.5%(P>0.05),在出生后1年,他们血清HBsAg阳性率分别为7.5%、5.0%和14.3%,而血清抗HBs阳性率则分别为92.5%、95.0%和85.7%,也无显著性差异(P>0.05);在接受抗病毒药物治疗期间,拉米夫定组孕妇发生皮疹、一过性ALT升高和肌酸激酶升高分别为5.0%、2.5%和2.5%,与替比夫定组的2.5%、7.5%和5.0%比,差异无统计学意义(P>0.05)。结论在孕后期应用拉米夫定或替比夫定抗病毒治疗均可有效降低HBV携带孕妇血清HBV DNA水平,对阻断新生儿HBV母婴传播是否有必要,还需要进一步扩大样本量和长期随访观察。

Objective The aim of this study was to analyze the efficacy and risks of lamivudine and telbivudine in blocking mother-to-infant intrauterine infection of hepatitis B virus(HBV).Methods 120 pregnant women with chronic hepatitis B viral carrier were enrolled in our hospital between June 2014 and June 2018,and at gestation 28 week,40 pregnant women received lamivudine,40 received telbivudine for antiviral therapy,and another 20 did not receive any antiviral agents.The antiviral regimen discontinued immediately after giving birth.All women and their children were followed-up for 12 months.Serum HBV DNA,HBsAg and HBsAb were assayed.Results At presentation,serum HBV DNA loads in the three groups were not significantly different(P>0.05);at delivery,serum HBV DNA loss were 100.0%in both groups receiving anti-viral therapy,hence their serum viral loads were significantly lower than that in the women without antiviral therapy【(7.6±1.5)lg copies/ml,P<0.05】,and three months after delivery,serum HBV DNA in the two antiviral groups returned back to high levels before enrollment,without significantly differences to that in the control(P<0.05);at delivery,serum HBsAg prevalence in 40 newborns in lamivudine-treated,40 in telbivudine-treated,and 21 in non-antiviral therapy group were 5.0%,5.0%and 9.5%(P>0.05),and at one year old,their serumHBsAg prevalence were 7.5%,5.0%and 14.3%,with serum anti-HBs positive rates of 92.5%,95.0%and 85.7%,respectively(P>0.05);during antiviral therapy,the incidence of rash,transient serum ALT elevation and creatinene kinase elevation in women with lamivudine treatment were 5.0%,2.5%and 2.5%,not much different as compared to 2.5%,7.5%and 5.0%,in telbivudine-treated women(P>0.05).Conclusion Both lamivudine and telbivudine could effectively reduce serum HBV DNA loads in pregnant women with hepatitis B infection,which might help block HBV intrauterine infection from mother to infants,and the medication is relatively safe as no severe untoward effects is found during the antiviral therapy.