HBV感染产妇应用替诺福韦酯期间哺乳婴儿安全性观察

Safety of breast-feeding infants during the use of tenofovir disoproxil fumarate in parturient with HBV infection

目的观察乙型肝炎病毒(hepatitis B Virus,HBV)感染产妇应用替诺福韦酯(tenofovir disoproxil fumarate,TDF)期间哺乳婴儿的安全性,为乙型肝炎母婴阻断流程的完善提供依据。方法选取妊娠期服用TDF行乙型肝炎母婴阻断且产后继续服用的产妇70例为研究对象,产后按照有无哺乳意愿分为哺乳组(42例)和人工喂养组(28例),观察两组产妇与新生儿围产期不良事件的发生率。随访至产后72周,观察不同喂养方式婴儿产后28周乙型肝炎病毒表面抗原(hepatitis B virus surface antigen,HBs Ag)及HBV DNA阳性率、乙型肝炎病毒表面抗体(hepatitis B virus surface antibody,HBs Ab)水平和不良事件发生率;观察产后28周、48周与72周婴幼儿的智力发育指数(mental development index,MDI)、精神运动发育指数(psychomotor development index,PDI)等智力发育指标与身长、头围等体格发育指标。结果产后28周两组婴儿HBs Ag和HBV DNA阳性率均为0%,哺乳组与人工喂养组婴儿HBs Ab滴度差异无统计学意义(χ~2=1.230,P=0.267)。哺乳组女婴28周和48周身长显著高于中国标准值,28周、48周和72周体重数值均高于中国标准值,哺乳组男婴48周体重高于中国标准值,差异均有统计学意义(P均<0.05),其余各时间点体格发育指标与中国标准值相比差异无统计学意义(P均>0.05);不同喂养方式婴幼儿上述指标的差异也无统计学意义(P>0.05);产后28周不同喂养方式婴儿骨密度差异无统计学意义(χ~2=0.12,P=0.732)。哺乳组婴儿产后28周和48周的MDI及PDI值高于人工喂养组,产后72周两组幼儿的MDI和PDI差异无统计学意义(P>0.05)。结论应用替诺福韦酯抗HBV治疗的产妇哺乳不增加HBV母婴传播率,且初步显示婴幼儿安全性良好。

To investigate the safety of breast-feeding infants during the use of tenofovir disoproxil fumarate in parturient with HBV infection to provide evidence for the improvement of HBV blocking process.Methods Total of 70 pregnant women infected with HBV who recieved TDF therapy during pregnancy and postpartum to block the mother to child transmission(MTCT)were selected and divided into breast feeding group(42 cases)and artificial feeding group(28 cases)according to breast-feeding intention.The incidence of maternal and neonatal adverse perinatal events were observed.The positive rate of HBsAg,HBV DNA and the level of HBsAb of babies in 28 weeks between the two groups were compared.Mental development index(MDI),psychomotor development index(PDI),length and head circumference of infants at the 28th week,48th week and 72nd week after delivery were also compared.Results At the 28th week after delivery,the positive rate of HBsAg and HBV DNA were both 0%in two groups and the level of HBsAb of infants between the two group was not statistically significant(χ2=1.230,P=0.267).Length and weight of girl infant in breast feeding group at the 28th week and 48th week were significantly higher than the Chinese standard value and the weight at the 28th week,48th week and 72nd week were also significantly higher than the Chinese standard value,the weight of boy infant in breast feeding group at the 48th week were significantly higher than the Chinese standard value(P<0.05).Compared with Chinese standard values,there were no significant differences in physical development indexes at other time points(P>0.05).The above indexes of infants with different feeding patterns had no statistically significant differences(P>0.05).Bone mineral density of infants with different feeding patterns at the 28th week after delivery was not statistically significant(χ2=0.12,P=0.732).Compared with the artificial feeding group,the MDI and PDI of infants in the breast feeding group increased significantly at the 28th week and 48th week after delivery.There was no significant difference in MDI and PDI between the two groups at the 72nd week after delivery(P>0.05).Conclusions Maternal with application of tenofovir anti-HBV treatment during lactation does not increase the rate of mother to child transmission,and preliminarily showed good safety for infants.