广西隆安县乙肝血源疫苗免疫长期效果研究

Study on long-term efficacy of plasma-derived hepatitis B vaccine in Long'an County,Guangxi

目的评价广西隆安县乙肝血源疫苗长期免疫效果,为乙肝疫苗加强免疫策略提供依据。方法在广西隆安县开展横断面调查,采用多阶段抽样方法选取766名1987—1989年出生,并于出生72 h内全程接种乙肝血源疫苗者作为研究对象。采集血清标本用微粒子酶免疫法（microparticle enzyme immunoassay,MEIA）检测乙肝表面抗原（hepatitis B surface antigen,HBs Ag）,抗乙肝病毒表面抗原抗体（antibody to HBs Ag,Anti-HBs）,抗乙肝病毒核心抗原抗体（antibody to HBV core antigen,Anti-HBc）。结果 766名研究对象中,HBs Ag携带率为4.96%,首针不及时接种组（10.42%）显著高于及时接种组HBs Ag阳性率（4.60%）（P〈0.05）。首针及时接种的718例研究对象中,HBs Ag和Anti-HBc阳性率分别为4.60%（95%CI：3.29-6.38）和22.42%（95%CI：19.52-25.62）。Anti-HBs阳性率为21.59%（95%CI：18.73-24.74）。Anti-HBs阳性者抗体几何平均浓度（geometric mean concentration,GMC）为98.39 m IU/m L（95%CI：60.87-135.91）,单独Anti-HBs阳性者平均GMC为47.34 m IU/m L（95%CI：40.58-54.10）,随着免疫年限延长呈下降趋势。GMC〈10 m IU/m L组随着免疫年限延长构成比呈上升趋势,而100-999.99 m IU/m L组构成比呈下降趋势。首针及时接种乙肝血源疫苗保护率为74.30%。结论乙肝血源疫苗免疫后26-28年抗体水平已降至较低水平,疫苗保护HBV感染和发病的效果已显著下降。建议继续提高新生儿乙肝疫苗首针接种及时率,对Anti-HBs阴性（GMC〈10 m IU/m L）且未感染HBV者应进行乙肝疫苗加强免疫。

Objective To evaluate the long-term effectiveness of the plasma-derived hepatitis B vaccine in Long＇anCounty,Guangxi,China,so as to provide the evidence for formulating the strategy of enhancing hepatitis B vaccine. Methods A cross-sectional investigation was conducted in Long＇an County,Guangxi. The multistage sampling method was used to selectsubjects. Totally 766 subjects who received 3 doses of plasma-derived HBV vaccine within 72 h after birth and who were bornfrom 1987 to 1989 were enrolled. The serum samples were collected to test for HBV markers which included hepatitis B surfaceantigen（HBs Ag）,anti- hepatitis B surface antibody（Anti- HBs）and hepatitis B core antibody（Anti- HBc）by using themicroparticle enzyme immunoassay. Results Among the 766 participants,the average HBs Ag prevalence was 4.96%. Thepositive rates of HBs Ag on subjects who delayed the first dose（10.42%）were higher than that of subjects who received the firstdose intime（4.60%）（P〈0.05）. Among the 718 subjects of the birth-dose intime group,the average positive rates of HBs Agand Anti-HBc were 4.60%（95%CI： 3.29-6.38）and 22.42%（95%CI： 19.52-25.62）,respectively,and the positive rate of Anti-HBs were 21.59%（95%CI： 18.73-24.74）. The geometric mean concentration（GMC）of Anti-HBs-positive subjects was 98.39 m IU/m L（95%CI： 60.87-135.91）.The average GMC of Anti-HBs for the subjects who were solely Anti-HBs-positive was47.34 m IU/m L（95% CI： 40.58- 54.10）. The proportion of the GMC〈10 m IU/m L group increased with the rising year ofvaccination,while the proportions of the 100-999.99 m IU/m L group declined with the rising year of vaccination. The efficacy ofplasma-derived hepatitis B vaccine was 74.30%. Conclusion The long-term effectiveness of the plasma-derived hepatitis B vaccine declines 26-28 years after vaccination. It seems that a booster dose is necessary for subjects who were anti-HBs〈10m IU/m L and not infected by HBV. Enhancing the rate of the birth-dose intime is one of the most important measures to preventand control HBV infection.