替诺福韦阻断乙型肝炎母婴传播的疗效及安全性研究

The efficacy and safety of tenofovir on blocking mother-infant transmission of hepatitis B

目的:探究替诺福韦阻断乙型肝炎母婴传播的疗效及安全性。方法:采用便利抽样法选取2016年8月至2018年1月就诊于昆明市第三人民医院肝一科及妇产科产前检查、门诊就诊或住院的孕妇或有妊娠意愿的育龄期妇女作为研究对象,其中治疗组按服用替诺福韦时间分为3组,A组孕前半年开始服用,B组孕中期(孕14周)开始服用,C组孕晚期(孕28周)开始服用,各30例,将同期30例不服用任何抗病毒药物的妇女作为对照组D组。比较4组治疗前和分娩时的基线特征、HBV DNA载量水平及HBs Ag水平与HBe Ag水平情况,统计并比较4组间母婴传播阻断率及不良反应情况。结果:3组治疗前和分娩时的基线特征差异无统计学意义(P> 0. 05); A、B、C 3组治疗前和分娩时HBV DNA载量水平、HBs Ag水平及HBe Ag水平均有明显差异(P <0. 05),但对照组D组治疗前和分娩时HBV DNA载量水平、HBs Ag水平及HBe Ag水平无明显差异(P> 0. 05); A、B、C 3组HBV母婴传播阻断率均高于D组,但A、B组间无明显差异(P> 0. 05),A、B组与C间有明显差异(P <0. 05),说明孕早期、中期服药的母婴传播阻断率显著高于孕晚期服药及不使用药物者;在新生儿及孕妇安全性方面,4组间比较均无明显差异(P <0. 05)。结论:替诺福韦作为乙肝抗病毒药物,能够有效达到阻断乙肝病毒母婴传播的作用,且孕早期、中期服药效果优于孕晚期服药,同时具有良好的安全性,因此值得临床推广和应用。

Objective： To explore the efficacy and safety of tenofovir on blocking mother-infant transmission of hepatitis B.Methods： Pregnant women were admitted to the Third People＇s Hospital of Kunming from August 2016 to January 2018 by convenience sampling method. The treatment groups were divided into 3 subgroups according to the time points that women used tenofovir,which are group A,in which women used tenofovir half a year before pregnancy; group B,in which women began to use tenofovir from second trimester（ 14 weeks gestation）; group C who started taking tenofovir from late pregnancy（ 28 weeks gestation）. There were 30 cases in each group,and another 30 women who didn＇t take any antiviral drugs at the same time were selected as the control group（ group D）. Baseline characteristics,HBV DNA load level,HBsAg level and HBeAg level were measured in 4 groups before and during childbirth. The interruption rate of mother to child transmission and adverse reactions among 4 groups were analyzed.Results： There was no significant difference in baseline characteristics among 3 groups before and during delivery（ P〈0. 05）. There were significant difference in the levels of HBV DNA load,HBsAg level and HBeAg level in the 3 groups before treatment and in the A,B and C groups（ P〈0. 05）,but there was no significant difference between the group D before and during childbirth,the level of HBV load,the level of D and the level of D. The 3 groups of A,B and C were higher than the group D,but there was no significant difference between the A and B groups（ P〈0. 05）,and there was a significant difference between A,B and C（ P〈0. 05）,the rate of mother to child transmission in the early and middle stages of pregnancy was significantly higher than that in the late pregnancy and those who did not use drugs. There was no significant difference among these 4 groups in the safety of newborns and pregnant women（ P〈0. 05）.Conclusion： Tenofovir can effectively block mother to child transmission of hepatitis B virus as a hepatitis B antiviral drug,and in the early and middle pregnancy medication is better than late pregnancy medication,with good safety,it is worthy of promotion and application.