AIM: To evaluate the efficacy of interruption of intrauterine infection of HBV with HBIG in pregnant women with positive HBeAg and HBsAg.METHODS: A prospective randomized controlled trial was adopted. Sixty cases wi...AIM: To evaluate the efficacy of interruption of intrauterine infection of HBV with HBIG in pregnant women with positive HBeAg and HBsAg.METHODS: A prospective randomized controlled trial was adopted. Sixty cases with positive HBeAg and HBsAg were coincident with the criteria of inclusion, and 8 cases were excluded. Fifty-two cases were analyzed (28 cases in trial group and 24 in control group). All cases in trial group received 200 IU HBIG intravenously every 4 wk for 3 times from the 28^th wk. The cases of control group received placebo in the same way. All pregnant women were detected for HBeAg and HBV-DNA at the beginning of the trial and end of the trial (delivery). The cord blood of all newborns were collected for detecting HBeAg and HBV-DNA simultaneously.RESULTS: For investigation of HBeAg of newborns in trial group, 6 of 28 cases of newborns had positive HBeAg, the HBeAg positive rate being 21.4%, the total rate of 95% CI being 8%-41%. In control group, 19 of 24 cases of newborns had positive HBeAg, HBeAg positive rate was 79.2%, the rate of 95%CI being 5%-93%. By statistical analysis, 2= 17.26, P 〈 0.01, RR = 0.27, 95% CI (6.3 × 10^-6, 8.6 × 10^-5). For investigation of HBV-DNA of newborns in trial group, 7 of 28 cases of newborns had positive HBV-DNA, HBV-DNA positive rate being 25%, the total rate of 95% CI being 11%-45%. In control group, 20 of 24 cases of newborns had positive HBV-DNA, HBV-DNA positive rate was 83.3%, the total rate of 95% CI being 63%-95%. By statistical analysis, X^2 = 17.62, P 〈 0.01, RR = 0.30, 95% CI (1.5 × 10^-5, 1.7× 10^-4). The results indicated that there was significant difference in HBeAg positive rate and HBV-DNA positive rate of newborns between the two groups. In trial group, 7 of 28 newborns had HBV-DNA positive, but the HBV-DNA load of newborns was lower than that of their mothers. In control group, 20 of 24 newborns still had HBV-DNA positive, and the HBV-DNA load of newborns was close to those of their mothers. Statistical analysis indicated that there was no significant difference in HBV- DNA load between postnatal women without HBIG intervention and their filial generations (T = 81.5, P 〉 0.1). CONCLUSION: It is effective and safe to prevent intrauterine infection of HBV with HBIG from the 28^th wk in pregnant women with positive HBeAg and HBsAg. In clinical application, those pregnant women with negative HBeAg and positive HBV-DNA also need to be interrupted by HBIG.展开更多
Objective To evaluate the efficacy of hepatitis B immune globulin (HBIG) in preventing intrauterine infection by hepatitis B virus (HBV) and to investigate its mechanism. Methods Forty eight pregnant women positiv...Objective To evaluate the efficacy of hepatitis B immune globulin (HBIG) in preventing intrauterine infection by hepatitis B virus (HBV) and to investigate its mechanism. Methods Forty eight pregnant women positive for hepatitis B surface antigen (HBsAg) were randomly divided into 2 groups. The 34 women in the study group were injected with HBIG during pregnancy; the other 14 women were controls. Maternal blood samples were taken before HBIG injection and at delivery. Neonatal blood samples were taken within 24 hours after birth before HBIG and hepatitis B vaccine were given. HBsAg and antibody to HBsAg (anti HBs) were tested by radioimmunoassay. Results None of the 35 newborns (including 2 twins) in the study group was positive for HBsAg, but 3 (21%) in the control group were positive (P=0.02). The HBsAg titers in the women in the study group decreased after HBIG injection. Of the 35 newborns in the study group, 32 (91%) were positive for anti HBs. Conclusion Systematic injections of HBIG during pregnancy may prevent intrauterine HBV infection, the mechanism of which may be reduction of maternal HBV viremia and production of fetal passive immunity.展开更多
基金Supported by the office of Science and Technology of Xinjiang,No.960505003
文摘AIM: To evaluate the efficacy of interruption of intrauterine infection of HBV with HBIG in pregnant women with positive HBeAg and HBsAg.METHODS: A prospective randomized controlled trial was adopted. Sixty cases with positive HBeAg and HBsAg were coincident with the criteria of inclusion, and 8 cases were excluded. Fifty-two cases were analyzed (28 cases in trial group and 24 in control group). All cases in trial group received 200 IU HBIG intravenously every 4 wk for 3 times from the 28^th wk. The cases of control group received placebo in the same way. All pregnant women were detected for HBeAg and HBV-DNA at the beginning of the trial and end of the trial (delivery). The cord blood of all newborns were collected for detecting HBeAg and HBV-DNA simultaneously.RESULTS: For investigation of HBeAg of newborns in trial group, 6 of 28 cases of newborns had positive HBeAg, the HBeAg positive rate being 21.4%, the total rate of 95% CI being 8%-41%. In control group, 19 of 24 cases of newborns had positive HBeAg, HBeAg positive rate was 79.2%, the rate of 95%CI being 5%-93%. By statistical analysis, 2= 17.26, P 〈 0.01, RR = 0.27, 95% CI (6.3 × 10^-6, 8.6 × 10^-5). For investigation of HBV-DNA of newborns in trial group, 7 of 28 cases of newborns had positive HBV-DNA, HBV-DNA positive rate being 25%, the total rate of 95% CI being 11%-45%. In control group, 20 of 24 cases of newborns had positive HBV-DNA, HBV-DNA positive rate was 83.3%, the total rate of 95% CI being 63%-95%. By statistical analysis, X^2 = 17.62, P 〈 0.01, RR = 0.30, 95% CI (1.5 × 10^-5, 1.7× 10^-4). The results indicated that there was significant difference in HBeAg positive rate and HBV-DNA positive rate of newborns between the two groups. In trial group, 7 of 28 newborns had HBV-DNA positive, but the HBV-DNA load of newborns was lower than that of their mothers. In control group, 20 of 24 newborns still had HBV-DNA positive, and the HBV-DNA load of newborns was close to those of their mothers. Statistical analysis indicated that there was no significant difference in HBV- DNA load between postnatal women without HBIG intervention and their filial generations (T = 81.5, P 〉 0.1). CONCLUSION: It is effective and safe to prevent intrauterine infection of HBV with HBIG from the 28^th wk in pregnant women with positive HBeAg and HBsAg. In clinical application, those pregnant women with negative HBeAg and positive HBV-DNA also need to be interrupted by HBIG.
文摘Objective To evaluate the efficacy of hepatitis B immune globulin (HBIG) in preventing intrauterine infection by hepatitis B virus (HBV) and to investigate its mechanism. Methods Forty eight pregnant women positive for hepatitis B surface antigen (HBsAg) were randomly divided into 2 groups. The 34 women in the study group were injected with HBIG during pregnancy; the other 14 women were controls. Maternal blood samples were taken before HBIG injection and at delivery. Neonatal blood samples were taken within 24 hours after birth before HBIG and hepatitis B vaccine were given. HBsAg and antibody to HBsAg (anti HBs) were tested by radioimmunoassay. Results None of the 35 newborns (including 2 twins) in the study group was positive for HBsAg, but 3 (21%) in the control group were positive (P=0.02). The HBsAg titers in the women in the study group decreased after HBIG injection. Of the 35 newborns in the study group, 32 (91%) were positive for anti HBs. Conclusion Systematic injections of HBIG during pregnancy may prevent intrauterine HBV infection, the mechanism of which may be reduction of maternal HBV viremia and production of fetal passive immunity.