Study For The Efficacy And Safety Of Telbivudine Treatment From Early Pregnancy To Prevent Mother-neonatal HBV Transmission

Objective:This study is to investigate the effects of chronic hepatitis B with high serum viral load in pregnant women in early pregnancy with telbivudine treatment for hepatitis B virus PMTCT and safety of mother and infant,the birth children long-term growth and intellectual development,to provide scientific theoretical basis for preventing mother-neonatal HBV transmission.Methods: The method of drug use:A total of 87 cases were collected,including 42 cases of telbivudine treatment group and 45 cases of the control group,the patients were grouped according to the patient’s informed consent.In the group LdT,patients were given LdT 600 mg/day,from week 12 of gestation,and were given compound glycyrrhizin for liver protection.In the control group,only the compound glycyrrhizin was used.All babies in both groups were injected with hepatitis B immune globulin(HBIG 200 IU)within 6 hours of parturition and at one month after parturition and vaccinated with recombinant HBV vaccine(20 μg)at 0,1 and 6 months.Evaluation method: The clinical manifestations of the two groups of pregnant women were observed before and after the experiment,we recorded adverse reactions of the medicine and detected liver function,quantitative HBVDNA in the two groups of pregnant women during experiment,HBVDNA and ALT results were compared between two groups.Two groups of infants at7 months test HBV markers,compared to 7 months old infant hepatitis B virus infection rate.Neonatal development indicators,neonatal birth time Apgar score,neonatal malformations were observed and recorded.The growth and intelligence development of children under 6 years old were followed up.Results: In the group LdT,the levels of HBVDNA before and after delivery at 12 weeks and prenatal ALT were significantly decreased(P < 0.01),while HBVDNA in the control group had no significant change(P>0.05).The recovery rate of ALT at prenatal in the control group(80%)was significantly lower than that of the treatment group(95.24%).No HBV infection was detected in all 42 cases of infants at 7 months in group LdT,which was significantly lower than that of the control group(5 cases were infected,the infection rate was 11.11%)(P < 0.05).Group LdT pregnant and lying in women were followed up after medication,and there was no adverse reaction.There were no statistical differences between the two groups infants’ height/weight or Apgar scores,deformity rate,growth and intelligence development of children under 6 years old.Conclusion: The experiment shows that early telbivudine treatment could sign-ificantly degrade the HBVDNA levels in pregnant women,significantly reduce theneonatal HBV infection rate,and stabilize the maternal liver function.It has good efficacy and safety for mother and child.