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目的评价乙型肝炎(乙肝)疫苗无应答儿童复种远期效果并比较小剂量皮内与常规剂量肌肉复种效果。方法自1999年9月开始,40名经筛检获得的无应答健康儿童随机接受3针肌肉(17人,10μg/针)或皮内(23人,2μg/针)复种,定期采血检测至复种后5年;80名应答儿童不复种,作为同期观察对照。在第5年,评价HBsAg特异性淋巴细胞免疫水平;对抗-HBs阴转者加强1针(5μg),12~14d评价抗体回忆应答。结果仅1名皮内复种者抗-HBs未达到10IU/L;在第5年,50%的肌肉复种者仍保持着抗-HBs≥10IU/L(尽管该指标显著低于应答对照者的85%)。抗-HBs阴转者(肌肉、皮内复种和应答对照分别为8、18和11人)在加强1针后,除2名皮内复种者外,均产生了强劲的抗体回忆应答(抗-HBs滴度分别平均上升至208、105和549IU/L);超过70%的无应答儿童外周血单个核细胞可检测到HBsAg特异性白细胞介素(IL)-2和IL-5的分泌。用抗-HBc阳转作为感染指标计算乙肝病毒人年感染率,皮内复种者为8.9%(8/89.9人年),高于应答对照者的3.6%(12/337.2人年),而肌肉复种者为4.3%(3/70.2人年),与应答对照者接近。结论无应答儿童3针肌肉复种效果虽达不到应答儿童初种的水平,但确能发挥重要的免疫保护作用。小剂量皮内复种效果不如相同针次常规剂量肌肉复种。
Objective To evaluate the long-term effect of multiple vaccination in children without response to hepatitis B (HBV) vaccine and to compare the effects of multiple intramuscular and multiple doses of intradermal and conventional doses of hepatitis B vaccine. Methods From September 1999, 40 randomly selected non-responder healthy children were randomized to triple-needle muscle (17, 10 μg / needle) or intradermal (23, 2 μg / After 5 years; 80 children responded to no crop, as the same period of observation and control. At the fifth year, the level of HBsAg-specific lymphocyte immunity was evaluated; one stitch (5 μg) was boosted against anti-HBs and the antibody recall response was evaluated from 12 to 14 days. Results Only 1 intradermal polyclonal antibody-HBs did not reach 10 IU / L; at 5 years, 50% of muscle miters maintained anti-HBs> 10 IU / L (although this was significantly lower than that of responders %). Anti-HBs inversions (muscle, intradermal inoculation and response controls of 8, 18, and 11, respectively) produced a strong antibody recall response (except for 2 intradermal inoculation) HBs titers increased to 208, 105 and 549 IU / L, respectively); HBsAg-specific interleukin (IL) -2 and IL-5 secretion were detected in peripheral blood mononuclear cells in more than 70% of nonresponsive children. The annual infection rate of hepatitis B virus was calculated using anti-HBc positive infection as an indicator of infection, with 8.9% (8/89.9 years) of intradermal inoculation and 3.6% (12 / 337.2 person-years) of responders, whereas muscle The number of multipliers was 4.3% (3 / 70.2 person-years), close to those responding to the controls. Conclusions Although the effect of the 3-acupuncture of the non-responding children on multiple-seed multiplication can not meet the level of the first seed in children, it can indeed play an important immunoprotective effect. The effect of low-dose intradermal compounding is not as good as that of the same dose of conventional muscle.