替比夫定治疗慢性HBV感染孕妇的疗效和安全性观察

目的探讨替比夫定(LDT)对控制妊娠合并慢性乙型肝炎病毒(HBV)感染引起的各型肝病活动和阻断HBV母婴传播的疗效及安全性。方法对47例ALT≥2×ULN,HBeAg阳性,HBV DNA≥1×105拷贝/毫升的慢性HBV感染孕妇(42例慢性乙型肝炎、2例慢性重型乙肝、3例乙肝肝硬化),于妊娠早期(12例)、中期(7例)、晚期(28例)在护肝对症治疗的基础上服用LDT,600mg,1次/天,新生儿出生后常规注射高效价乙肝免疫球蛋白和重组酵母乙型肝炎疫苗。观察分娩前后病毒学及生化学应答率、母婴并发症发生率、HBV母婴阻断率、婴幼儿发育情况及药物不良反应。结果 47例接受LDT治疗的慢性HBV感染孕妇,分娩前HBV DNA检测不到率、HBeAg转阴率分别为89.4%和17.0%,ALT复常率为87.2%;母婴并发症发生率低;所有新生儿7个月时检测HBsAg、HBeAg均阴性,并可测得抗-HBs,HBV母婴阻断率达100%;对新生儿经7个月以上随访,均发育正常;母亲分娩后继续治疗,病情稳定。结论 LDT能快速降低慢性HBV感染孕妇的HBV DNA水平,有效地控制肝炎活动、阻断HBV母婴传播,未见婴幼儿发育异常及药物不良反应。

Efficacy and Safety of Telbivudine Using in Pregnant Patients with Chronic HBV Infection

Objective To investigate the efficacy and safety of telbivdine using in controling chronic HBV hepatic disease activity and blocking HBV mother-to-infant transmission during the stage of pregancy.Methods A total of 47 chronic HBV-infected pregnant patients(including 42 chronic hepatitis B patients,2 chronic severe hepatitis patients and 3 cirrhosis patients) with HBeAg-positive,as well as alanine aminotransferase(ALT) more than 2 times the upper limit of normal and HBV DNA≥1×105 copies/ml were enrolled,including early stage(12 patients),intermediate stage(7 patients) and last stage(28 patients) of pregnancy.Patients were treated with telbivudine 600mg once daily and liver-protecting medications.Newborns were injected with anti-hepatis B immunoglobulin and hepatitis B vaccine.The response rate of virological and bio-chemical before and after delivery,the prevalence of mother and infant complications,blocking rate HBV from mother to infants,infant development and drug adverse events were investigated.Results In 47 chronic HBV-infected pregnant patients who were treated with telbivudine,HBV DNA undetectable rate was 89.4%,HBeAg loss rate was 17.0%,ALT normalization rate was 87.2% prior to delivery.Mother and infant complications were rare.At seventh months after birth HBsAg and HBeAg of all newborns was negative,and anti-HBs was positive.Mother-to-infant blocking rate was 100%.All newborns development were normal during more than seven months follow-up.Mothers′ liver function were stable during treatment.Conclusion The levels of serum HBV DNA in chronic HBV-infected pregnant patients treated with telbivudine were quickly reduced.Hepatitis activity was effectively controlled.Mother-to-infant transmission was blocked.Infant developmental anomaly and drug adverse event were not reported.