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目的评价乙肝血源疫苗在婴幼儿人群接种12年间的保护效果。方法用随机双盲安慰剂对照现场试验的方法比较接种组和对照组(共350人)接种后12年间的血清乙肝表面抗体、表面抗原的变化。结果 12年间,疫苗组乙肝表面抗体阳性率虽然一直高于对照组,但是在第12年时两组阳性率差别已经比较小(46.1%和33.9%,P<0.05),而且疫苗组表面抗体阳性者的抗体中位数S/N值比对照组阳性者低(分别为15和36,P<0.0001)。然而接种5～10年后,疫苗预防乙肝表面抗原慢性携带状态的保护率保持在83%～100%之间。12年时,从对照组中检出14个表面抗原慢性携带者(7.6%),在疫苗组中仅检出1例(0.6%),保护率为92%,统计学显著性检验P<0.01。结论接种后12年乙肝疫苗减少接种儿童表面抗原慢性携带状态的效果良好,仍无需要加强免疫的充分理由。
Objective To evaluate the protective effect of hepatitis B blood-borne vaccine on infants and young children’s inoculation for 12 years. Methods A randomized, double-blind, placebo-controlled, placebo-controlled study was conducted to compare the changes of serum hepatitis B surface antigen and surface antigen in vaccinated and control groups (350 patients) after 12 years of vaccination. Results Although the positive rate of HBsAg in the vaccine group was consistently higher than that of the control group at 12 years, the difference between the two groups was relatively small at the 12th year (46.1% and 33.9%, P <0.05), and the antibody positive in the vaccine group The median antibody S / N ratio was lower in the control group (15 and 36, respectively, P <0.0001). However, after 5 to 10 years of inoculation, the protection rate of the vaccine in preventing the chronic carrier state of hepatitis B surface antigen remains between 83% and 100%. At 12 years, 14 chronic carriers (7.6%) of the surface antigen were detected in the control group, only 1 (0.6%) in the vaccine group, with a protection rate of 92% and a statistically significant test P <0.01 . Conclusion Hepatitis B vaccine reduced the incidence of chronic carriers of surface antigen in children immunized 12 years after vaccination, and there is still no sufficient reason to strengthen immunity.