重组乙型肝炎疫苗阻断乙型肝炎病毒母婴传播方案的保护效果评价

Efficacy of recombinant hepatitis B vaccine and low-dose hepatitis B immune globulin in preventing mother-infant transmission of hepatitis B virus infection

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 determine the efficacy of recombinant hepatitis B (rHB) vaccine and low-dose hepatitis B immune globulin (HBIG) in the prevention of mother-infant transmission of hepatitis B virus (HBV) infection. Methods rHB vaccine was administered to two groups of healthy neonates born to mothers with both hepatitis B surface antigen and e antigen positive in Guangxi, Hunan and Hebei province. Two hundred eighty-nine subjects were included in active immunization group, receiving triple doses of rHB vaccine given i.m. at 0, 1 and 6 month intervals; while 186 subjects receiving 50 IU HBIG at birth with triple doses of rHB vaccine in the low-dose HBIG group. Results Efficacy of active immunization alone was 87.8 % (95% CI : 83.6- 91.9 ). Efficacy of rHB vaccine and HBIG was 91.2 %(95% CI : 86.7- 95.6 ). No significant differences in efficacy by type of rHB vaccine ( P = 0.707 2 ), immunoprophylaxis programs ( P = 0.295 5 ) and regions of living ( P = 0.998 7 ) were noticed. Seroprotection rates (anti-HBs≥10 mIU/ml) were detected in 91.1 % and 93.5 % in rHB vaccine alone recipients and rHB vaccine plus HBIG recipients, with geometric mean titer (GMT) of 153 mIU/ml and 164 mIU/ml at 1 year of age, respectively. Anti-rHBs decreased significantly with years after vaccination ( χ 2= 60.47 , P = 0.000 1 ). Seroprotection rates of anti-rHBs antibodies decreased to 65.0 % and 66.6 % at 4 years of age in rHB vaccine alone recipients and rHB vaccine plus HBIG recipients, with GMT of 55 mIU/ml and 56 mIU/ml, respectively. Conclusion These results suggested that the effectiveness of rHB vaccine plus low-dose HBIG was much better than only active plasma-derived vaccine; however, methods used for anti-rHBs assay need to be evaluated and verified.