替诺福韦酯和替比夫定治疗妊娠慢性乙肝患者的疗效及母婴阻断的有效性研究

Clinical observation of Telbivudine and tenofovir in the treatment of chronic hepatitis B during pregnancy and reducing mother-to-child transmission of HBV

目的探讨替诺福韦酯和替比夫定对慢性乙肝妊娠患者的疗效及母婴阻断的有效性和安全性等。方法选取2016年1月—2017年12月台州市立医院诊治的80例HBe Ag阳性、HBV DNA>106IU/ml妊娠患者,按照随机数字表均分为2组。妊娠中晚期对照组使用替比夫定治疗,研究组使用替诺福韦酯治疗,2组孕妇产后3个月停药。2组婴儿出生后均采取阻断治疗,在治疗前、分娩前检测孕妇血清ALT、HBV DNA等水平。在婴儿出生时、出生7个月、出生1年观察血清HBe Ag、HBs Ag阳性及HBV DNA≥100 IU/ml例数。观察比较2组肝功能、病毒学应答、婴儿生长发育、乙肝母婴传播、不良反应等情况。结果分娩前研究组HBV DNA、ALT低于对照组,HBV-DNA转阴率(95%)、ALT复常率(97%)高于对照组,差异有统计学意义(均P<0.05)。2组分娩婴儿阿式评分、体重等比较差异无统计学意义(P>0.05)。婴儿出生时,研究组新生儿阻断成功率(100%)高于对照组(72.5%),出生1年后研究组婴儿血清HBe Ag、HBs Ag阳性率和HBV DNA≥100 IU/ml例数低于对照组,差异有统计学意义(均P<0.05)。2组母婴未见明显不良反应。结论妊娠期口服替诺福韦可降低乙肝感染孕妇血清HBV DNA水平,改善肝功能,提高母婴传播阻断率,降低婴儿乙肝病毒感染率,无明显不良反应,安全性较好,值得推广。

Objective To explore the efficacy and safety of telbivudine and tenofovir in the treatment of the patients with chronic hepatitis B during pregnancy and its effect on reducing mother-to-child vertical transmission of HBV. Methods From January,2016 to December,2017,80 HBe Ag positive pregnant women,with HBV DNA 106 IU/ml,were randomly divided into two groups（ n = 40）. The patients in the control group received telbivudine in the middle and late stages,while the patients in the research group received tenofovir in the middle and late stages. The medicines were withdrawn until three months after postpartum. All the newborns were given blockade therapy. Alanine aminotransferase（ ALT） and HBV-DNA were detected before the treatment and delivery. The HBe Ag,HBs Ag positive and HBV DNA≥100 IU/ml were detected when babies were born,seven months and one years after the birth. The biochemical indexes,virology response,infant growth and development,mother to child transmission of hepatitis B,and adverse reactions were observed and compared between the two groups. Results Before the delivery,the HBV DNA and ALT levels in the research group were less than those in the control group,the ALT normalization rate（ 97%） and the negative conversion rate of HBV-DNA（ 95%） in the research group were higher than those in the control group,the differences were statistically significant（ P〈0. 05）. There were no significant differences in the Apgar score,weight between the two groups of childbirth. The success rate of neonatal interruption in the research group（ 100%） was higher than that in the control group（ 72. 5%）. One year after the birth of infants,the serum HBe Ag,positive rate of HBs Ag and HBV DNA 100 IU/ml in the research group were lower than those in the control group,there was no obvious adverse reaction between the two groups of mothers and infants. Conclusion Tenofovir can reduce maternal serum HBV DNA levels of hepatitis B infection,improving liver function,the blocking rate of vertical transmission,reducing infant HBV infection rate,having no significant adverse reactions,good safety,and it was worth popularizing.