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【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 000copy/mL者分为两组:治疗组20例,新生儿出生后给予乙肝疫苗10μg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200U臀部肌肉注射,20d1次,共3次,注射乙肝疫苗后3d同一部位皮内注射GM-CSF 10μg/kg。对照组20例,乙肝疫苗10μg三角肌肉注射(0、1、6方案),乙肝免疫球蛋白200U臀部肌肉注射,20d1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 observe the clinical effect of granulocyte-monocyte colony stimulating factor (GM-CSF) as adjuvant of yeast recombinant hepatitis B vaccine (rHBvac) on infants with intrauterine infection of HBV and On serum Thl / Th2 cytokines. 【Methods】 Five newborns with HBsAg (+) and HBV DNA> 1 000 copies / mL at birth and at 1 month of age were divided into two groups: 20 in the treatment group and 10 in the triangular muscle of the newborn after birth (Vaccination time by 0,1,6 program), hepatitis B immunoglobulin 200U intramuscular injection, 20d1 times, a total of 3 times, injection of hepatitis B vaccine 3d the same site intradermal injection of GM-CSF 10μg / kg. Control group of 20 cases, hepatitis B vaccine 10μg triangular muscle injection (0,1,6 program), hepatitis B immunoglobulin 200U intramuscular injection, 20d1 times, a total of 3 times. Peripheral venous blood samples were collected at the age of 1 year to detect five items of hepatitis B, HBV DNA changes and serum IL-4 and IFN-γ levels. 【Results】 The incidence of HBsAg negative rate was 25% (5/20) in infants of 7 months in treatment group and 5% (1/20) in 7 months in control group. There was no significant difference between the two groups (P> 0.05). The IFN-γlevel of the treatment group was higher than that of the control group, there was significant difference between the two groups (P <0.01). There was no significant difference between the two groups (P> 0.05). 【Conclusion】 GM-CSF combined with hepatitis B vaccine and hepatitis B immunoglobulin can improve HBsAg negative rate and regulate Th1 / Th2 cytokine balance in HBV intrauterine infection, and have certain therapeutic effect on HBV intrauterine infection.