【目的】 初步观察重组粒细胞-巨噬细胞集落刺激因子(granulocyte-monocyte colony stimulating factor,GM-CSF)作为酵母重组乙型肝炎疫苗(rHBvac)的佐剂对HBV宫内感染婴儿治疗临床作用及对血清Thl/ Th2细胞因子的影响。 【方法】 新生儿出生时及1个月龄检查乙肝五项HBsAg(＋)和HBV DNA＞1 000 copy/mL者分为两组:治疗组 20例,新生儿出生后给予乙肝疫苗10 μg三角肌肉注射(疫苗注射时间按0、1、6方案),乙肝免疫球蛋白200 U臀部肌肉注射,20 d 1次,共3次,注射乙肝疫苗后3 d同一部位皮内注射GM-CSF 10 μg/kg。对照组20例,乙肝疫苗10 μg三角肌肉注射(0、1、6方案),乙肝免疫球蛋白200 U臀部肌肉注射,20 d 1次,共3次。1岁时抽外周静脉血检测乙肝五项、HBV DNA的变化及血清IL-4和IFN-γ水平。 【结果】 治疗组7个月婴儿HBsAg转阴率25%(5/20),对照组7个月婴儿转阴率为5%(1/20),两组比较差异无统计学意义(P＞0.05);治疗组IFN-γ水平高于对照组,两组比较差异有统计学意义(P<0.01),IL-4水平两组比较差异无统计学意义(P＞0.05)。 【结论】 GM-CSF 联合乙肝疫苗及乙肝免疫球蛋白可提高HBV宫内感染儿HBsAg转阴率,并调节Th1/Th2细胞因子平衡,对HBV宫内感染儿有一定的治疗作用。

【Objective】 To investigate the effects of granulocyte-macrophage colony stimulating factor(GM-CSF) on intrauterine hepatitis B virus (HBV) infected infants and the serum Thl/Th2 balance. 【Methods】 Forty intrauterine infected infants entered the study.They were randomized into two groups.Twenty babies were assigned to GM-CSF group and received combined therapy with 10 μg of rHBvac and 200 U HBIG injected intramuscularly at different sites,10 μg/kg of GM-CSF intradermally after three days at receiving rHBvac the same point.Twenty babies were assigned to control group and receiving 200 U HBIG and 10 μg intramuscular rHBvac injections at different sites.One year after birth,the post-treatment serum samples were collected to test HBV-DNA quantification and other HBV serological markers with the baseline samples at the same time.Levels of interferon-gamma (IFN-γ) and interleukin (IL)-4 in blood serum in spontaneous and superuatant were measured by enzyme-linked immunosorbent assay(ELISA). 【Results】 All subjects completed the three -dose schedule,no adverse events were reported in either group.After the treatment,5 children became HBsAg and HBV DNA negative in GM-CSF group,however the difference did not reach to a significant level;One children became HBsAg and HBV DNA negative in control group.The IFN-γ levels of GM-CSF group were significantly higher than those of control group(P<0.01).There was no significant diference in IL-4 levels among the two groups (P>0.05). 【Conclusion】 Combined GM-CSF,rHBvac and HBIG therapy have some use in intrauterine infected infants who are not protected by immunoprophylaxis.