替诺福韦在HBV感染患者哺乳期使用有效性及安全性的单中心回顾性队列研究

Efficacy and safety of tenofovir in the parturient with HBV infection during breast-feeding:a single-center retrospective cohort study

目的探索替诺福韦在乙型肝炎病毒(HBV)感染患者哺乳期使用的有效性及安全性。方法采用回顾性队列研究,选取妊娠期服用替诺福韦行HBV母婴阻断的患者114例,产后按照婴儿是否通过母乳接触到药物分为暴露组(55例)和对照组(59例),观察两组产妇哺乳期抗乙肝病毒治疗及病毒载量情况;婴儿乙肝阻断情况及生长发育、健康情况。结果暴露组和对照组新生儿性别、Apgar评分、早产儿比例、转新生儿科和出生缺陷差异没有统计学意义。暴露组和对照组婴儿随访时平均月龄分别为(8.80±2.90)个月和(8.44±3.04)个月,两组婴儿HBs Ag阳性率均为0%。暴露组和对照组出生后身高、体重、所患疾病差异没有统计学意义。结论HBV感染患者在哺乳期使用替诺福韦未显示对婴儿生长发育有明显影响,哺乳期继续使用替诺福韦的有效性尚需大样本高质量证据。

Objective To determine the efficacy and safety of tenofovir disoproxil fumarate(TDF)in patients with hepatitis B virus(HBV)infection during lactation.Methods A retrospective cohort study was conducted to select 114 patients who were treated with TDF during pregnancy to block hepatitis B from mother to child.After the delivery,they were divided into an exposure group(n=55)and a control group(n=59)according to whether the infants were exposed to drugs through breast milk.The blocking of hepatitis B in infants and their growth,development and health were observed.Results There were no significant differences in gender,Apgar score,proportion of premature infants,transfer to neonatology and birth defects between the exposure group and the control group.The mean follow-up age of infants in the exposure group and the control group was(8.80±2.90)months and(8.44±3.04)months,respectively.The positive rate of HBsAg in the two groups was 0%.There was no significant difference in the height,weight and health between the exposure group and the control group.Conclusion The use of TDF in HBV infected patients during lactation has no obvious effect on the growth and development of infants.Research with large samples and high-quality evidence of the effect of TDF use during lactation is needed.