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目的观察新生儿接种重组乙型肝炎(乙肝)疫苗的长期免疫效果。方法于1996年10月7日—1997年5月31日在德清县招募135名符合纳入标准的新生儿,其中35人的母亲乙肝表面抗原(HBs Ag)阳性,设为阳性组;100人的母亲HBs Ag阴性,设为阴性组。所有新生儿按0-1-6月的程序接种重组乙肝疫苗(酿酒酵母),分别于12月龄、13岁(2010年)和15岁(2012年)进行随访,并检测乙肝相关血清学指标,评估重组乙肝疫苗的长期免疫效果。结果 135名新生儿12月龄时随访到123人(91.11%),2010年随访到95人(70.37%),2012年随访到46人(34.07%),三次随访研究对象HBs Ag检测结果均为阴性。阳性组2010年发现3例乙肝核心抗体(HBc Ab)阳性,2012年无新增阳性;12月龄、2010年、2012年乙肝表面抗体(HBs Ab)阳性率分别为88.89%、81.48%和80.00%;12月龄HBs Ab水平与2010年和2012年的HBs Ab水平均呈正相关(P<0.05)。阴性组未发现HBc Ab阳性者;12月龄、2010年、2012年HBs Ab阳性率分别为91.18%、54.41%和52.78%;12月龄HBs Ab水平与2010年、2012年的HBs Ab水平均无统计学关联(P>0.05)。校正母亲HBs Ag影响后,加强免疫与HBs Ab阳性率间不存在统计学关联(P>0.05)。结论重组乙肝疫苗基础免疫后13~15年内保护效果较好,普通人群不需要加强免疫;母亲未感染乙肝的新生儿完成基础免疫后,其青少年时期的HBs Ab水平与第12月龄时HBs Ab水平相关。
Objective To observe the long-term immunization effect of neonatal vaccination with recombinant hepatitis B (hepatitis B) vaccine. Methods A total of 135 eligible newborns were enrolled in Deqing County from October 7, 1996 to May 31, 1997. 35 of them were mothers with HBs Ag positive, The mother was negative for HBs Ag and was set as negative. All newborns were vaccinated with recombinant hepatitis B vaccine (Saccharomyces cerevisiae) according to the procedure from January to June. The patients were followed up at 12 months, 13 years (2010) and 15 years (2012 years), respectively. Serological markers of hepatitis B , To assess the long-term immune response to recombinant hepatitis B vaccine. Results 135 newborns were followed up to 123 (91.11%) at 12 months of age, 95 (70.37%) were followed up in 2010 and 46 (34.07%) were followed up in 2012. The HBsAg detection results of three follow-up studies were all negative. In the positive group, three cases of HBc Ab were positive in 2010 and no new positive in 2012. The positive rates of HBs Ab at 12 months, 2010 and 2012 were 88.89%, 81.48% and 80.00 %. The levels of HBs Ab at 12 months were positively correlated with the levels of HBs Ab in 2010 and 2012 (P <0.05). The positive rate of HBs Ab in 12 months, 2010 and 2012 was 91.18%, 54.41% and 52.78% respectively. The levels of HBs Ab at 12 months and HBs Ab levels in 2010 and 2012 No statistical correlation (P> 0.05). After adjusting for the influence of mothers HBs Ag, there was no statistical correlation between the booster immunization and the positive rate of HBs Ab (P> 0.05). CONCLUSION: The protective effect of recombinant hepatitis B vaccine is good in 13-15 years after basic immunization, and the general population does not need to be boosted. After completing basic immunization, the level of HBs Ab in adolescence is similar to that of HBs Ab Horizontal correlation.