预防乙型肝炎病毒母婴传播的随机对照研究

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

目的探讨乙肝免疫球蛋白（HBIG）预防乙型肝炎病毒（HBV）母婴垂直传播的效果。方法以2001年1月至2005年5月在台州医院产科初次进行妊娠健康检查，HBsAg测定阳性或HBsAg、HBeAg均阳性孕妇作为研究对象，共279例。将单纯HBsAg阳性孕妇与HBsAg、HBeAg双阳性孕妇分别应用随机数表方法随机分组，分别为单阳注射组（n=80）、单阳对照组（n=60）、双阳注射组（n=79）、双阳对照组（n=60）。单阳注射组、双阳注射组于妊娠加周开始肌肉注射HBIG 200U，每4周注射1次，直至临产。两对照组不注射HBIG。4组孕妇所产婴儿，除常规接种乙肝疫苗外，均于出生后16h内和2周肌肉注射HBIG。然后随访并测定婴儿HBsAg。结果单阳注射组、单阳对照组、双阳注射组、双阳对照组所生婴儿HBsAg感染率分别为3％、13％、10％、32％。单阳注射组与单阳对照组之间（x^2=6．07，P〈0．05），以及双阳注射组与双阳对照组之间婴儿HBsAg感染率（x^2=10．11，P〈0．01）均有统计学意义，注射HBIG组，对单纯HBsAg阳性孕妇及HBsAg、HBeAg双阳性孕妇，出生婴儿HBsAg感染率均显著低于对照组；单阳注射组与双阳注射组之间婴儿HBsAg感染率差异亦有统计学意义，说明HBIG对单纯HBsAg阳性孕妇预防效果优于HBsAg、HBeAg双阳性孕妇。结论HBIG能有效预防母婴传播，降低HBV感染率。因此，妊娠妇女应及时进行健康检查，发现HBV感染阳性，及时采取注射HBIG等有效措施，以促进优生优育。

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.