不同剂量乙肝疫苗与HBIG联合免疫阻断HBV母婴传播的效果对比

目的 探讨10 μg和20 μg乙肝疫苗与HBIG联合免疫阻断HBV母婴传播的效果.方法 124例HBsAg阳性孕妇所生的婴儿随机分为两组,即10 μg乙肝疫苗组和20 μg乙肝疫苗组.婴儿于出生6h内及30 d分别注射200 IU HBIG,同时分别于出生24 h内、1个月及6个月注射3次10 μg或20 μg重组酵母乙肝疫苗.检测婴儿出生时以及1岁时血清HBV标志物.结果 两组新生儿血清HBsAg、HBeAg及抗-HBe阳性率与滴度之间差别均无统计学意义（P＞0.05）.所有新生儿血清HBV DNA水平均小于检测下限（500 U/ml）.出生12个月时,所有124例婴儿血清HBsAg和HBeAg检测结果均为阴性;血清HBV DNA水平均在检测下限以下;10 μg和20 μg乙肝疫苗组血清抗-HBs阳性率分别为90.3％和96.8％,差异无统计学意义（P＞0.05）;抗-HBs水平分别为325.5±342.2 mIU/ml和463.7±353.3 mIU/ml,后者显著高于前者（P=0.01）.而且,20 μg乙肝疫苗组产生高应答抗-HBs（＞ 100 mIU/ml）的比例显著高于10μg乙肝疫苗组（P =0.035）.结论 20 μg乙肝疫苗联合HBIG方案阻断HBV母婴传播的效果优于10 μg乙肝疫苗联合HBIG方案.

Evaluation on protective efficacy of different doses of hepatitis B vaccine combined with hepatitis B immune globulin in preventing mother-to-infant transmission of hepatitis B virus

Objective To evaluate the protective effect of 10 μg and 20 μg hepatitis B vaccines combined with hepatitis B immune globulin （HBIG） in preventing mother-to-infant transmission of HBV.Methods One hundred and twenty-four infants whose mothers were HBsAg positive were randomly divided into two groups,i.e.10 μg and 20 μg hepatitis B vaccine group.Hepatitis B vaccine at 10 μg or 20 μg dose was inoculated on 0,1,6 month schedule with administration of 200IU HBIG at birth and 1 month.Serum HBV markers of the infants were detected at birth and 12 month.Results At birth,the positive rates and levels of serum HBsAg,HBeAg and anti-HBe in 124 infants between the two groups had no significant difference（P 〉0.05）,serum HBV DNA was not detected.At 12 month,serum HBsAg,HBeAg and HBV DNA in 124 infants were negative; the positive rate of anti-HBs was 90.3% and 96.8% （P 〉 0.05） ; the level of anti-HBs was 325.5 ± 342.2 mIU/ml and 463.7 ± 353.3 mIU/ml（P =0.01） in 10 μg and 20 μg hepatitis B vaccine group,respectively.The rate of more than 100 mIU/ml anti-HBs in 20 μg hepatitis B vaccine group was significantly higher than that in 10 μg hepatitis B vaccine group（P =0.035）.Conclusion Administration of 20 μg hepatitis B vaccine combined HBIG has better effect on preventing mother-to-infant transmission of HBV than that of 10 μg hepatitis B vaccine combined HBIG.