替诺福韦、替比夫定分别联合双重免疫方案对HBV母婴传播阻断效果的比较

Comparison of the effects of tenofovir and telbivudine combined with dual immunization regimen on blocking mother-to-child transmission of HBV during pregnancy

目的比较替诺福韦、替比夫定分别联合双重免疫方案对妊娠HBV母婴传播的阻断效果。方法选取2016年1月至2018年7月首都医科大学附属北京佑安医院妇产科收治的82例HBV感染孕妇,随机分为替诺福韦组与替比夫定组,各41例。2组均于孕28周开始服药,替诺福韦组300mg/d;替比夫定组600mg/d。母乳喂养者产后停止服药,不进行母乳喂养者则用药至产后4周。2组胎儿娩出后注射乙型肝炎免疫球蛋白与乙型肝炎疫苗。比较2组服药前1d、分娩前3d内孕妇血清ALT和HBV DNA水平,新生儿出生时、出生后1年的HBsAg阳性率、HBeAg阳性率、HBV DNA≥100IU/mL发生率,妊娠结局与不良反应。结果2组孕妇分娩前3d内血清ALT、HBV DNA均较服药前1d显著降低(P<0.05)。替诺福韦组分娩前3d血清ALT、HBV DNA分别为(32.65±6.91)U/L、(2.89±0.56)lgIU/mL,显著低于替比夫定组的(43.25±7.11)U/L、(3.67±0.67)lgIU/mL(P<0.05)。2组出生时与出生后1年的HBsAg阳性率、HBeAg阳性率、HBV DNA≥100IU/mL发生率的差异均无统计学意义(P>0.05)。2组治疗期间均未见流产、产后出血、肝肾功能不全,早产、剖宫产、胎儿畸形、贫血、妊高症、胆汁酸增高发生率的差异无统计学意义(P>0.05)。结论替诺福韦与替比夫定联合双重免疫方案均可有效抑制HBV复制,降低血清病毒载量,阻断HBV母婴传播,而前者对HBV抑制作用更强,有利于改善患者肝功能,临床价值更高。

Objective To compare the blocking effects of tenofovir and telbivudine combined with dual immunization regimen on maternal-fetal transmission of hepatitis B virus (HBV) during pregnancy. Methods A total of 82 HBV-infected pregnant women admitted to our hospital from January 2016 to July 2018 were randomly divided into tenofovir group and telbivudine group,41 cases each.The 2 groups started taking drugs at 28 weeks of gestation,the tenofovir group receiving tenofovir 300 mg once daily,the telbivudine group receiving telbivudine 600 mg once daily.Breastfeeders stopped medication after delivery,and those who did not breastfeed were given medication until 4 weeks after delivery.Both 2 groups of infants were injected with hepatitis B immunoglobulins and hepatitis B vaccines.The serum alanine aminotransferase (ALT) and HBV DNA levels of the pregnant women 1 day before taking medication and within 3 days before delivery,the hepatitis B surface antigen (HBsAg) positive rate,hepatitis B e antigen (HBeAg) positive rate,incidence of HBV DNA ≥100 IU/mL of the infants at birth and 1 year after birth,pregnancy outcomes and adverse reactions were compared between the 2 groups. Results The serum ALT and HBV DNA levels within 3 days before delivery were significantly lower than 1 day before taking medication in both groups ( P <0.05).The serum ALT and HBV DNA levels in the tenofovir group within 3 days before delivery were significantly lower than those in the telbivudine group (32.65 ± 6.91 vs 43.25 ± 7.11 U/L,2.89 ± 0.56 vs 3.67 ± 0.67 IU/mL,P <0.05).There were no significant differences in HBsAg positive rate,HBeAg positive rate or incidence of HBV DNA≥100 IU/ml between the 2 groups at birth or 1 year after birth ( P >0.05).No abortion,postpartum hemorrhage,liver or kidney dysfunction were observed during the treatment in the 2 groups.There were no significant differences in the incidence rates of premature delivery,cesarean section,fetal malformation,maternal anemia,pregnancy-induced hypertension and maternal high serum bile acid between the 2 groups ( P >0.05). Conclusion Both tenofovir and telbivudine combined with dual immunization regimen can effectively inhibit HBV replication,reduce serum viral load and block HBV mother-to-child transmission.The former has higher clinical value,which has stronger inhibitory effect on HBV and is beneficial to improve liver function.