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目的分析国产重组乙型肝炎(乙肝)疫苗(Hepatitis B Vaccine,HepB)及其与乙肝免疫球蛋白(HBIG)联合应用的母婴阻断效果。方法用分层随机抽样的方法,随机抽取4个市州的9个县级医院作为调查单位,对调查单位HBsAg筛查阳性的413名母亲所生新生儿分别接种5μg、10μg重组酵母HepB以及HBIG,血清采用酶联免疫吸附试验(ELISA)检测HBV标志物(Hepatisis B Virus Markers,HBVM),比较不同剂量(10μg、5μg、5μg和5μg、5μg、5μg)重组酵母HepB与HBIG联合免疫阻断HBV母婴传播的效果。结果接种5μg重组酵母HepB联合免疫组(5μg联合免疫组)43人,10μg重组酵母HepB联合免疫组(10μg联合免疫组)35人。接种5μg联合免疫组新生儿HBsAg阳性率9.30%,HBsAg和HBeAg双阳性率2.33%,Anti-HBs阳性率为93.02%,Anti-HBc阳性率为16.28%,阻断HBV母婴传播率为89.06%;接种10μg联合免疫组新生儿HBsAg阳性率为2.86%,Anti-HBs阳性率为88.57%,阻断HBV母婴传播率为96.99%;5μg联合免疫组新生儿(χ~2=5.377,P<0.05)与10μg联合免疫组(χ~2=6.045,P<0.05)其HBsAg阳性率均低于未联合免疫者,5μg联合免疫组新生儿HBsAg和HBeAg双阳性率(χ~2=6.167,P<0.05)以及抗HBc阳性率(χ~2=4.479,P<0.05)均明显低于未联合免疫者,10μg联合免疫组无HBsAg和HBeAg双阳性感染且无AntiHBc阳性。结论 10μg重组酵母HepB与HBIG联合免疫的母婴阻断效果优于5μg重组酵母HepB与HBIG联合免疫。
Objective To analyze the blocking effect of domestic recombinant Hepatitis B Vaccine (HepB) and its combination with hepatitis B immunoglobulin (HBIG). Methods Stratified random sampling method was used to randomly select 9 county-level hospitals in 4 prefectures and cities as investigators. Five hundred and seventy micrograms of recombinant HepB and HBIG , Hepatitis B Virus Markers (HBVM) were detected by enzyme-linked immunosorbent assay (ELISA). HepBV HBeAg was co-immunized with Hepatitis B virus Markers (HBVM) at different doses (10μg, 5μg, 5μg and 5μg, 5μg, 5μg) The effect of mother to child transmission. Results Inoculated with 5μg HepB recombinant yeast (5μg combined immunization group) and 5μg recombinant yeast HepB combined immunization group (10μg combined immunization group). The positive rate of HBsAg and HBeAg in neonates vaccinated with 5μg combined immunization group was 9.30%, the positive rate of HBsAg and HBeAg was 2.33%, the positive rate of Anti-HBs was 93.02%, the positive rate of Anti-HBc was 16.28% and the rate of blocking mother-to-child transmission of HBV was 89.06% ; The positive rate of HBsAg in neonates vaccinated with 10μg of combination immunization group was 2.86%, the positive rate of Anti-HBs was 88.57%, the rate of blocking mother-to-child transmission of HBV was 96.99%; The newborn with 5μg combined immunization group (χ ~ 2 = 5.377, P < 0.05) and 10μg combined immunization group (χ ~ 2 = 6.045, P <0.05). The positive rates of HBsAg in neonates with 5μg combined immunization group were significantly higher than those without combined immunization (χ ~ 2 = 6.167, P <0.05) and the positive rate of anti-HBc (χ ~ 2 = 4.479, P <0.05) were significantly lower than those without combined immunization, 10μg combined immunization group without HBsAg and HBeAg double positive infection without AntiHBc positive. Conclusion The combined immunization with 10μg recombinant HepB and HBIG is superior to the combined immunization with 5μg recombinant HepB and HBIG.