| Objective:To evaluate the efficacy and safety of tenofovir disoproxil fumarate in the treatment of pregnant women with HBeAg positive chronic hepatitis B.Methods:(1)The relevant data of 203 pregnant women first diagnosed as HBeAg positive chronic hepatitis B(HBeAg positive,HBV DNA>5×102 IU/ml,ALT>5×ULN)during the mid-term pregnancy and their offspring were collected in the Fifth People’s Hospital of Suzhou during pregnancy from January 2016 to October 2019.(2)108 pregnant women who were treated with tenofovir disoproxil fumarate on the basis of routine hepatoprotective therapy were set as study group,while 95 pregnant women who were only treated with hepatoprotective drugs and lowering enzyme drugs were set as control group.When the pregnant women were re-examined ALT<2xULN,the intravenous drugs of hepatoprotective and lowering enzyme were changed to oral drugs,and the pregnant women were allowed to leave hospital.The pregnant women in the study group should continue taking oral tenofovir disoproxil fumarate until 4 weeks after delivery after that they were transferred to liver disease department to continue treatment.(3)The ALT data of the two groups were collected at the baseline,at 4,8 and 12 weeks after treatment,as well as at the time of delivery and 4 weeks after delivery.The ALT outcome of the two groups was analyzed to compare the effects of different treatment.The data of other relevant test indexes of the two groups at the baseline and at the time of delivery were collected to analyze the effects of different treatment methods on pregnant women’s viral load,renal function,calcium and phosphorus metabolism,coagulation function and nutritional status.The length and cost of hospitalization for chronic hepatitis B treatment,perinatal maternal and child complications,adverse drug reactions,time and mode of termination of pregnancy and breastfeeding were recorded and analyzed in the two groups.The data of HBsAg,HBV DNA,height and weight of the two groups at birth and 8 months old were collected to analyze the effects of different treatment methods on the mother-to-child transmission blocked of hepatitis B virus and neonatal growth.The questionnaires of the two groups were collected to analyze the factors that affected the pregnant women with HBeAg positive chronic hepatitis B to choose tenofovir disoproxil fumarate treatment.(4)Statistical methods:normal distribution tests for all data,if it’s normal,the measurement data,represented by mean ± standard deviation(x±s),t test was used for inter-group comparison.For counting data,by frequency(N,%)means,χ2 test was used for inter-group comparison.A logistic regression model was used for multivariate analysis.All collected data were processed SPSS 21.0 statistical software,P<0.05 indicated that the difference was statistically significant.Results(1)The HBV DNA level of pregnent women in the study group decreased significantly compared with the baseline,and the difference was statistically significant(P<0.001).The differences of HBV DNA level and HBV DNA negative conversion rate between the two groups were statistically significant(P<0.001).At different time point of detection,the ALT normalization rate of pregnant women in the study group was respectively higher than that in the control group and the difference was statistically significant(P<0.05).At different time point of detection,the ALT level of pregnant women in the study group was respectively lower than that in the control group and the difference was statistically significant(P<0.05).The average hospitalization time of pregnant women was shorter and the average cost was less in the study group than that in the control group,the differences were statistically significant(P<0.001).But both groups of pregnant women showed ALT level fluctuations at 4 weeks after delivery.(2)The level of delivery hemoglobin,albumin,serum total protein in the study group were higher than those in the control group,and the prothrombin time was lower than that in the control group,and the differences were statistically significant(P<0.05).There were no significant differences in platelet,blood calcium,blood phosphorus,serum creatinine and estimated glomerular filtration rate between the two groups(P>0.05).(3)The mean time of termination of pregnancy in the study group was later than that in the control group,and the rate of cesarean section was lower than that in the control group,and the difference was statistically significant(P<0.05).The incidence of gestational diabetes mellitus,postpartum hemorrhage,premature delivery,intrahepatic cholestasis of pregnancy,hypoproteinemia and anemia in the study group were all significantly lower than those in the control group,and the differences were statistically significant(P<0.05).There were no significant differences in the incidence of other perinatal complications and adverse drug reactions between the two groups(P>0.05).(4)The success rate of the mother-to-child blocked of hepatitis B virus in the study group was higher than that in the control group and the difference was statistically significant(P=0.008).The breastfeeding rate of pregnant women in the study group was higher than that in the control group and the difference was statistically significant(P=0.016).There were no significant differences in height and weight between the two groups at birth and 8 months old(P>0.05).(5)Multivariate logistic regression analysis showed that:educational level,payment method,abnormal liver function history,knowledge of chronic hepatitis B treatment,medication necessity belief were independent factors that influencing choice of the treatment with tenofovir disoproxil fumarate in pregnant women with HBeAg positive chronic hepatitis B(P<0.05).ConclusionsThe pregnant women with HBeAg positive chronic hepatitis B receive tenofovir disoproxil fumarate treatment,which can help them to promote the recovery of hepatitis B,improve the success rate of the mother-to-child blocking,reduce the risk of perinatal complications and improve the pregnant process and outcome.The treatment method can produce good socio-economic benefits and have no obvious adverse effects on mother and child.Reducing the economic burden of patients’ treatment and improving patients’cognition level of pregnant women,which will help the pregnant women with HBeAg positive chronic hepatitis B to choose tenofovir disoproxil fumarate treatment. |
