| Objective To study the clinical efficacy and safety of tenofovir combined with immunotherapy in interrupting the vertical transmission of hepatitis B virus(HBV).Methods Subjects:154 pregnant women infected with hepatitis B virus(HBV)were regularly prenatal examination in our hospital and given birth in our hospital.Fluorescent real-time quantitative polymerase chain reaction(PCR)was used to detect maternal blood during the first and second trimester of pregnancy.For hepatitis B virus DNA(HBV DNA)levels,pregnant women with HBV DNA>2.0E+05 IU/ml were randomly divided into the tenofovir disoproxil(TDF)treatment group(59 cases)and the control group I(non-TDF treatment group).Pregnant women with 2.0E+05IU/ml?HBV DNA?20 IU/ml were included in the control group II 34 cases,and HBV DNA<20 IU/ml for the control group III 19 cases.The treatment group started TDF treatment at 26 to 32 weeks,300 mg/d.Pregnant women of all groups regularly pre-administered prenatal examinations,and strengthened maternal and child care.The medication group observed adverse drug reactions.The levels of HBV DNA and alanine transaminase(ALT)in each group and before delivery were examined.Immediately after childbirth,infants in each group took umbilical cord blood to check serum hepatitis B surface antigen(HBsAg),and they were standardized to receive active and passive immunoprophylaxis and were followed up to 7 months of age.The vertical transmission of mothers and infants was recorded,the growth and development of infants,and adverse events during the perinatal period and post-natal visits were recorded.Results:In this study,154 pregnant women were in accordance with the study conditions.In the control group I,1 pregnant woman had lost the nasal bone of the fetus but had no abnormal chromosomes,she left the study at 27 weeks of gestation.153 infants were eventually included,and all were immunized and followed up.(1)TDF group and control group I:1)The maternal age,gestational age,number of delivery,serum HBV DNA,hepatitis B e antigen(HBeAg)positive rate,and ALT level were not statistically significant between the two groups when pregnant women were enrolled;The level of serum ALT before delivery was significantly lower than that before the group,but there was no significant difference between the two groups before delivery(28.9+2.5vs 22.1+2.9 IU/L),and the difference was not statistically significant(P>0.05);2)The pre-delivery serum HBV DNA negative rate was 28.8%(17/59)and 7.3%(3/41),TDF group was significantly higher than the control group I,the difference was statistically significant(?~2=6.986,P=0.008);3)The HBsAg positive rate of neonatal umbilical cord blood was 3.4%(2/59)and21.9%(9/41),the difference between the two groups was statistically significant(?~2=6.558,P=0.01);There was no significant difference in the gestational age at birth,birth weight,body length,Apgar score(1 min),male infant rate,natural delivery rate,breastfeeding rate,and malformation rate of the three groups at birth(P all>0.05);When the infants were followed up to 7 months of age,The TDF group immediately stopped taking the drug after childbirth and the follow-up infant was 7 months old.The positive rate of serum HBsAg in infants'peripheral blood was 0%and 12.2%(5/41),respectively,There was no case of infants delivered by pregnant women in TDF group,there was a statistically significant difference between the two groups(?~2=5.224,P=0.022).4)Among the two groups of 100 infants.The positive rates of HBsAg at 7months of age in infants delivered by vaginal delivery and cesarean section were 5.8%and 3.2%,respectively,there was no significant difference between the two groups(?~2=0.002,P=0.96);the positive rate of HBsAg at 7 months of age in breast feeding and artificial feeding was 6%and 3%respectively,there was no statistically significant difference between the two(?~2=0.021,P=0.884),and the positive rates of HBsAg at 7 months of age in male and female infants were 4.5%and 6%,respectively,and there was no significant difference between them(?~2=0.000,P=1);while the chance for HBeAg positive infants to transmit HBV through vertical transmission was significantly higher than that of HBeAg negative ones,the positive rate of HBsAg at 7 months of age was 6.4%and 0%respectively,and there was no significant difference between them(P=0.506).(2)Control group I,control group II,and control group III:1)There was no significant difference in the age,gestational age,and delivery times of the three groups of pregnant women when they were enrolled(P>0.05);The serum ALT levels in the first three groups were 37.3±4.5?15.9±1.2and17.3±3.1IU/L,respectively,The difference between the three groups was statistically significant(P<0.001),while there was no significant difference between the control group II and the control group III(P=0.513);the serum ALT levels before delivery were22.1±2.9?17.6±1.5,and 15.5±1.5 IU/L,respectively,There was no statistical difference between the three groups(P=0.174);2)The HBsAg positive rates of neonatal umbilical cord blood were 21.9%(9/41),0%and 0%,respectively,and there was a statistically significant difference between the three groups(?~2=11.436,P=0.001).There was no significant difference in the gestational age at birth,birth weight,body length,Apgar score(1 min),male infant rate,natural delivery rate,breastfeeding rate,and malformation rate of the three groups at birth(P all>0.05);When the infants were followed up to 7 months of age,the positive rate of HBsAg in the periphera.The failure rate of mother-infant vertical transmission in the control group I was significantly higher than that of the control group.Group II and control group III,the difference between the blood of the three groups of infants was 12.2%(5/41),0%and 0%,respectively,the three groups was statistically significant(?~2=5.248,P=0.034);3)Among the three groups of 94 infants,the positive rates of HBsAg at 7 months of age for infants delivered by vaginal delivery and cesarean section were 5.9%and3.8%,respectively,there was no significant difference between the two groups(?~2=0.000,P=1).The positive rate of HBsAg at 7 months of age for breast-fed and artificial-fed infants was 6%and 3.7%,respectively,there was no significant difference between the two groups(?~2=0.000,P=1);The positive rates of HBsAg in male infants and female infants at the age of 7 months were 5.7%and 4.9%,respectively,there was no significant difference between the two groups(?~2=0.000,P=1);while the mothers were HBeAg-positive delivery infants and young children through the vertical transmission of HBV infection was significantly higher than the HBeAg-negative,at 7 months of age,HBsAg-positive rate was 7.8%and 0%,respectively,there was a statistically significant difference between the two(?~2=6.628,P=0.01);Maternal serum HBV DNA>2.0E+05IU/ml infants who had a higher chance of transmission of HBV through vertical transmission than HBV DNA?2.0E+05IU/ml.The positive rate of HBsAg at 7 months was 12.2%and 0%,respectively,there was no significant difference between the two(?~2=4.62,P=0.032).(3)During all maternal studies in the TDF group,the control group I,the control group II,and the control group III,only one patient in the TDF group had an elevated ALT at 4 weeks postpartum,and the rest did not have any relationship with TDF antiviral treatment.Adverse events;In infants and young children,only one patient in the TDF group was found to have polycystic kidneys on the left side,while no congenital malformations were found in the infants.There was no abnormal growth and development during follow-up.Conclusions:(1)The use of TDF antiviral therapy in pregnant women with high viral load during the second and third trimester of pregnancy can reduce the level of HBV DNA,increase the blocking rate of vertical transmission of maternal and neonatal hepatitis B,and reduce the risk of mother-infant vertical transmission of hepatitis B virus.(2)Pregnant women with serum HBV DNA>2.0E+05 iu/ml and HBeAg-positive are high risk factors for the failure of mother-to-infant vertical transmission;(3)After infants delivered by HBV-infected pregnant women undergo standard immunoprophylaxis,the mode of delivery,infant gender,and feeding patterns are not related to the failure rate of mother-infant vertical transmission of hepatitis B virus.Andshould be encouraged chronic hepatitis B pregnant women including high HBV DNA levels and HBeAg-positive spontaneous delivery and breastfeeding;(4)The high viral load of hepatitis B pregnant women used TDF antiviral therapy during the second and third trimesters of pregnancy,no adverse reactions were found in both mothers and infants,and the safety was good. |
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