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从1500名孕妇中筛查出82名HBsAg≥1∶64滴度的阳性携带者的新生儿,按随机、双盲、设安慰剂的原则将研究对象分为疫苗组和对照组(人数比为3∶1)。疫苗组在新生儿出生24小时内注射第1针,1月、6月龄分别注射第2针、第3针乙肝疫苗,对照组按同样程序注射安慰剂。在第13年时抗HBs阳性率仍高达5932%(35/59);对照组13年来有2353%(4/17)受到自然感染后变为抗HBs阳性,疫苗组与对照组有显著性差异(P<005)。疫苗组的抗HBs阳性者中,抗HBsGMT峰值在第12个月,S/N值为6884,到13年时已下降到1782。相当于高峰的1/4,但仍明显高于对照组。除出生时疫苗组与对照组HBsAg阳性率无明显差异外,疫苗组HBsAg阳性率一直明显低于对照组,在第13年时疫苗组和对照组的HBsAg阳性率分别为1864%、4706%,有显著性差异(P<005)。
Eighty-five newborns with positive HBsAg ≥1:64 titer were screened out from 1,500 pregnant women. The subjects were divided into vaccine group and control group according to the randomized, double-blind and placebo-based principle 3: 1). In the vaccine group, the first needle was injected within 24 hours of newborn’s birth, the second needle and the third needle of hepatitis B vaccine were injected at January and 6 months, and the control group was injected with placebo. The positive rate of anti-HBs was still as high as 5932% (35/59) at the 13th year. In the control group, 2353% (4/17) were naturally infected and became antiHBs positive in 13 years. The control group had significant difference (P <0 05). Anti-HBs positive in the vaccine group, anti- HBsGMT peak in the 12th month, S / N value of 68 84, 13 years had dropped to 17 82. Equivalent to 1/4 of the peak, but still significantly higher than the control group. The positive rates of HBsAg in the vaccine group were significantly lower than those in the control group except for the positive rate of HBsAg in the vaccine group and the control group at the time of birth. The positive rates of HBsAg in the vaccine group and the control group were 1864% and 47% respectively at the 13th year 06%, there was a significant difference (P <0 05).