摘要
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。
To evaluate protective efficacy of a plasma-derived hepatitis B vaccine during 12 years after vaccination. Methods A 12-year follow-up of 350 children who participated a randomized, double blind, placebo-controlled trial in 1982. Results During the 12 years after vaccination, more vaccinated children had anti-HBs of 10 S/N ratios or more than did the controls. At the 12 years 46.1% of the vaccinated and 33.9% of the controls retained antiHBs levels of S/N ratios ≥10 (P<0.05). However, at 12 years median S/N ratio of anti- HBs of the vaccinated children with detectable anti-HBs was lower than that of the controls (15 vs 36,P<0.0001). Protective efficacy against HBsAg carriage status at 5～10 years after vaccination varied from 83% to 100%. At 12 years, 14 chronic HBsAg carriers were identified among the controls, whereas only 1 case was noted in the vaccinated group (7.6% vs 0.6%, P<0.01), account for an efficacy of 92%. Conclusions Protective efficacy against chronic HBsAg carriage was satisfactory at 12 years after vaccination. No evidence was showed to support a booster of hepatitis B vaccine at this time.
出处
《中国医学科学院学报》
CAS
CSCD
北大核心
1998年第2期89-94,共6页
Acta Academiae Medicinae Sinicae
基金
美国中华医学基金(93-582)
关键词
乙肝血源疫苗
远期保护率
婴幼儿
乙型肝炎
plasma-derived hepatitis B vaccines long-term efficacy
chronic HBsAg carriage
