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目的探讨乙型肝炎(乙肝)疫苗(Hep B)正常和高应答新生儿基础免疫后5年抗体持久性及其影响因素。方法选择Hep B基础免疫正常和高应答且未进行加强免疫的新生儿,分别于基础免疫后1~6月和5年采血检测乙肝病毒(HBV)表面抗体(HBs Ab)、HBV核心抗体(HBc Ab)和HBV表面抗原(HBs Ag),分析HBs Ab抗体水平及影响因素。结果在1 883名新生儿调查对象中,HBs Ab阳性率从Hep B基础免疫后1~6月的100%降至基础免疫后5年的49.92%,几何平均浓度(GMC)从525.62(95%CI:504.65~547.47)m IU/ml降至10.68(95%CI:9.83~11.61)m IU/ml。母亲HBs Ag阳性、阴性、不详的新生儿基础免疫后5年HBs Ab阳性率分别为76.19%、50.29%、47.67%(χ2=6.83,P=0.033),GMC分别为16.45m IU/ml、10.66m IU/ml、10.52m IU/ml(F=0.59,P=0.553)。多因素分析显示,基础免疫高免疫应答者、母亲HBs Ag阳性者基础免疫后5年HBs Ab阳性率分别高于正常免疫应答者和母亲HBs Ag阴性者。新生儿Hep B基础免疫后5年内HBV突破性感染率为0.85%(16/1 883),未发现慢性感染者。结论 Hep B基础免疫正常和高应答新生儿在免疫后5年约一半儿童HBs Ab仍处于保护水平,新生儿基础免疫后抗体持久性与其基础免疫后抗体反应水平和母亲HBs Ag感染状态相关。
Objective To investigate the persistence of antibody and its influencing factors at 5 years after basic immunity in normal and high-response neonates of Hepatitis B (Hepatitis B) vaccine. Methods Newborn infants with normal and high basal immunity of Hep B and no response to booster immunization were enrolled in this study. Blood samples were collected from 1 to 6 months and 5 years after the basal immunization for detection of HBs Ab, HBcA Ab) and HBV surface antigen (HBsAg), HBs Ab antibody levels and influencing factors. Results In 1 883 newborns, the positive rate of HBs Ab decreased from 100% in January to June after basic immunization to 49.92% in 5 years after basic immunization. The geometric mean concentration (GMC) decreased from 525.62 (95% CI: 504.65 ~ 547.47) m IU / ml to 10.68 (95% CI: 9.83 ~ 11.61) mIU / ml. The positive rates of HBs Ab in 5 years after primary immunization of mothers with positive, negative and unknown neonates were 76.19%, 50.29% and 47.67% respectively (χ2 = 6.83, P = 0.033), and GMC were 16.45 mIU / ml and 10.66 m IU / ml, 10.52 m IU / ml (F = 0.59, P = 0.553). Multivariate analysis showed that the positive rate of HBsAb in the basal immunized immune responders and mothers with HBsAg positive 5 years after basic immunization were higher than those in normal immunocompetent and mothers with HBsAg negative respectively. The breakthrough rate of HBV infection within 5 years after newborn Hep B basic immunization was 0.85% (16/1 883). No chronic infection was found. Conclusions HBs Ab in children with normal and high-response basal immunity of Hep B-based immunocompetent and high responders are still at protection level in about 5 years after immunization. Persistence of the antibody after basal immunization is related to the level of basal immune antibody response and mother’s status of HBsAg infection.