[A randomized controlled trial on effect of hepatitis B immune globulin in preventing hepatitis B virus transmission from mothers to infants].

OBJECTIVE: To explore the effects of hepatitis B immune globulin (HBIG) in prevention of mother-to-infant hepatitis B virus (HBV) transmission. METHOD: A total of 279 pregnant women positive for HBsAg alone or for both HBsAg and HBeAg were enrolled into this study from January 2001 to May 2005. They were respectively divided into two groups at random, namely, only HBsAg-positiveexperimental group (n = 80), only HBsAg-positive control group (n = 60), both HBsAg and HBeAg-positive experimental group (n = 79) and both HBsAg and HBeAg-positive control group (n = 60). The two experimental groups were injected with HBIG once every four weeks until labor. The two control groups received no HBIG. The infants received intramuscular HBIG 16 hours after birth and two weeks later, in addition to routine immunization with hepatitis B vaccine. The infants were followed up and HBsAg was determined. RESULTS: The HBsAg infection rates of babies in the four groups were respectively 3%, 13%, 10%, 32%. The infection rate of the infants whose mothers were injected with HBIG was significantly lower than that of the control group. CONCLUSION: The HBIG could effectively prevent HBV transmission from mothers to infants and reduce the HBV infection rate.