不同剂量HBIG联合乙肝疫苗阻断HBV母婴传播效果的随机对照研究

Comparing the efficacy of passive-active immunoprophylaxis using different doses of hepatitis B immunoglobulin in newborns of HBsAg positive mothers

目的 :评价乙肝疫苗联合不同剂量乙型肝炎免疫球蛋白(hepatitis B immunoglobulin,HBIG)对HBV母婴阻断的效果,探讨有效经济的联合免疫阻断方法。方法:将HBsAg阳性母亲的新生儿随机分为100 IU HBIG免疫组和200 IU HBIG免疫组,分别在出生12 h内注射100 IU或200 IU HBIG,同时新生儿都按0、1、6的程序接种10μg乙肝疫苗,在婴儿7个月龄时观察HBV母婴阻断效果。结果:100 IU、200 IU组母婴阻断成功率分别为98.3%、98.0%,两组的阻断效果无明显差异,结合母亲HBV感染状态分析,两组的阻断效果亦无明显差异。结论:在新生儿HBV母婴阻断中,100 IU HBIG或200 IU HBIG联合10μg乙肝疫苗的主被动联合免疫可获相似的阻断效果。

Objective：To explore economic and efficient way to block perinatal transmission of HBV by passive-active immunoprophylaxis with different doses of hepatitis B immunoglobulin（HBIG） in newborns with HBsAg positive mothers in China.Methods：The newborns with HBsAg-positive mothers were randomly divided into 2 groups and received 100 IU and 200 IU HBIG respectively within 12 hours after birth.Meanwhile all the newborns were received 3 doses of 10 μg yeast recombinant hepatitis B vaccine（HB vaccine） according to EPI procedure.Post-vaccination tests to detect HBsAg and anti-HBs were assessed at 7 months of age.Results：The success rate of blocking perinatal transmission in newborns of 100 IU and 200 IU group were 98.3% and 98.0% respectively.The difference of blocking efficacy between the two groups was not significant,and the HBsAg positive rates between the two groups were also not significantly different when combined with analysis of mothers＇ HBeAg status.Conclusion：Combined with 10 μg yeast recombinant hepatitis B vaccine,the passive-active immunoprophylaxis using 100 IU HBIG was similar to 200 IU HBIG to prevent HBV infection of infant with HBsAg positive mother.