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为观察我国研制开发的乙型肝炎 (乙肝 )基因重组 (CHO)疫苗阻断乙肝病毒母婴传播的效果 ,选乙肝表面抗原 (HBsAg)、乙肝e抗原 (HBeAg)和乙肝核心抗体 (抗 -HBc) 3项均阳性的母亲所生婴儿 ,用乙肝CHO疫苗免疫 ,并随访观察 3年。婴儿随机分为A组 (5 2例 )和B组 (5 0例 ) ,A组为单纯疫苗组 ,注射 3次乙肝CHO疫苗 (0、1、6个月 ,10 μg/次 ) ;B组为疫苗加 5 0IU乙肝免疫球蛋白 (HBIG)组 ,同A组一样注射 3次乙肝CHO疫苗 ,但在 0月时同时注射HBIG(5 0IU)。全程免疫后 2~ 12个月、13~ 2 4个月、2 5~ 36个月分别采血 ,以固相放射免疫 (RIA)法检测乙肝表面抗体 (抗 -HBs)、HBsAg和抗 -HBc。综合 3次随访结果 ,单独及时全程接种乙肝CHO疫苗组 ,婴儿抗-HBs阳性率为 82 6 9% ,无应答率为 3 85 % ,HBsAg阳性率为 13 46 % ,保护率为 83 17% ;乙肝CHO疫苗加HBIG组 ,抗 -HBs阳性率为 90 0 0 % ,无应答率为 2 0 0 % ,HBsAg阳性率为 8 0 0 % ,保护率为 90 0 0 %。A、B两组的保护率虽不同 ,但差异无显著统计学意义 (χ2 =0 77,P =0 3788)。由此可见 ,乙肝CHO疫苗具有良好的安全性和免疫原性 ,可有效阻断乙肝病毒的母婴传播 ,出生时加注 5 0IUHBIG效果更好。
To observe the effect of hepatitis B (HBV) gene recombinant (CHO) vaccine developed in China on blocking the mother-to-child transmission of hepatitis B virus, HBsAg, HBeAg and anti-HBc ) 3 were positive mothers born infants, with the hepatitis B CHO vaccine immunization and follow-up observation of 3 years. The infants were randomly divided into group A (n = 52) and group B (n = 50). Group A was a simple vaccine group and injected with three times of hepatitis B vaccine (0,1,6 months, 10 μg / The vaccine was supplemented with 500 IU of hepatitis B immunoglobulin (HBIG). The vaccine was injected three times in the same way as in group A, but at the same time, HBIG (50 IU) was injected at the same time. The blood samples were collected from 2 to 12 months, 13 to 24 months and 25 to 36 months after the whole immunization. The anti-HBs, HBsAg and anti-HBc were detected by solid-phase radioimmunoassay (RIA). According to the 3 follow-up results, the positive rate of anti-HBs in infants was 82 6 9%, the rate of non-response was 3 85%, the positive rate of HBsAg was 13 46%, and the protection rate was 83 17%. In the HB vaccine group, the positive rate of anti-HBs was 90 0%, the rate of non-response was 200%, the positive rate of HBsAg was 80% and the protection rate was 90 0 0%. Although the protection rates of A and B groups were different, the difference was not statistically significant (χ2 = 0 77, P = 0 3788). Thus, the hepatitis B CHO vaccine has good safety and immunogenicity, which can effectively block the mother-to-child transmission of hepatitis B virus. It is better to add 50 IUHBIG at birth.