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目的 评价国产重组乙型肝炎 (乙肝 )疫苗及其与中效价乙肝免疫球蛋白 (HBIG)联合应用母婴阻断方案的保护效果。方法 在广西等 3个地区 ,对乙肝病毒双阳性母亲新生儿 ,应用重组乙肝疫苗和重组乙肝疫苗加 5 0IUHBIG两种母婴阻断方案免疫新生儿 ,共随访单纯重组乙肝疫苗母婴阻断儿 2 89例 ,重组乙肝疫苗加HBIG阻断儿 186例。结果 单纯重组乙肝疫苗的母婴阻断效果为 87.8% (95 %CI :83.6～ 91.9) ,重组乙肝疫苗加HBIG的阻断效果为 91.2 % (95 %CI:86 .7～95 .6 ) ,重组 (酵母 )乙肝疫苗和重组 (CHO细胞 )乙肝疫苗间 (P =0 .70 72 )、两种母婴阻断方案间 (P =0 .2 95 5 )及各地免疫人群间 (P =0 .9987)的母婴阻断效果差异均无显著统计学意义。两种母婴阻断方案免疫新生儿间抗 HBs的阳转率 (P =0 .3188)和抗体滴度 (GMT)间 (P =0 .892 5 )差异均无显著统计学意义 ,首剂免疫后 1年 ,抗 HBs阳性率在单纯重组乙肝疫苗组和重组乙肝疫苗加HBIG组分别为 91.1%和 93.5 % ,GMT分别为 15 3mIU/ml和 16 4mIU/ml,以后逐年显著下降 (线性趋势检验χ2 =6 0 .4 7,P =0 .0 0 0 1) ,至免疫后第 4年 ,阳性率分别降为 6 5 .0 %和 6 6 .6 % ,GMT仅为第一年的1/ 3。结论 重组乙肝疫苗加中效价HBIG的母婴阻断效果可达 90 %以?
Objective To evaluate the protective effect of domestic recombinant hepatitis B vaccine and its combination with mid-titer hepatitis B immunoglobulin (HBIG). Methods Three newborns with double-positive hepatitis B virus (HBV) positive mothers were immunized with recombinant hepatitis B vaccine and recombinant hepatitis B vaccine plus 50 IUHBIG in three areas, including Guangxi. 2 89 cases, recombinant hepatitis B vaccine plus HBIG block in 186 cases. Results The blocking effect of recombinant hepatitis B vaccine alone was 87.8% (95% CI: 83.6-91.9) and that of recombinant hepatitis B vaccine plus HBIG was 91.2% (95% CI: 86.7-95.6) (P = 0.7072) between the recombinant (yeast) hepatitis B vaccine and the recombinant (CHO cell) hepatitis B vaccine (P = 0.952) and between immunized groups .9987) no significant difference in the blocking effect of maternal and infant. There was no significant difference in the positive rates of anti-HBs immunization (P = 0. 3188) and antibody titers (GMT) between immunized newborns (P = .892 5) One year after immunization, the positive rate of anti-HBs was 91.1% and 93.5% in the recombinant hepatitis B vaccine alone and in the recombinant hepatitis B vaccine plus HBIG group, with a GMT of 15 3 mIU / ml and 16 4 mlU / ml, respectively, Test χ2 = 60.77, P = 0.0101), the positive rate was reduced to 65.5% and 66.6% respectively at the 4th year after immunization, and the GMT was only in the first year 1/3. Conclusion The blocking effect of recombinant hepatitis B vaccine plus HB-HBIG can reach 90%.