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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宫内感染婴儿的治疗作用。方法:新生儿抽股静脉血检查乙肝五项,HBsAg(+)和HBV DNA>1 000copies/ml者,分为两组:治疗组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200IU臀部肌肉注射,每隔20天1次,共3次,注射乙肝疫苗后3天同一部位皮内注射GM-CSF 10μg/kg。对照组新生儿出生后给予乙肝疫苗10μg三角肌肉注射(0、1、6方案),乙肝免疫球蛋白每200IU臀部肌肉注射,每隔20天1次,共3次。于1月龄复查乙肝五项,若HBsAg(-)排除研究,HBsAg(+)进入研究,两组均20例。1岁时抽外周静脉血检测乙肝五项、HBV DNA的变化及T淋巴细胞亚群的水平。结果:治疗组1岁婴儿HBsAg转阴率25.00%,对照组1岁婴儿转阴率为5.00%,两组比较差异无统计学意义(χ2=3.14,P>0.05);治疗组CD4+百分数高于对照组(t=11.67,P<0.05),CD8+百分数低于对照组(t=6.25,P<0.05),CD4+/CD8+比值高于对照组(t=13.06,P<0.05),两组比较差异均有统计学意义(P<0.05)。结论:GM-CSF联合乙肝疫苗及乙肝免疫球蛋白对HBV宫内感染儿有一定治疗作用。
Objective: To observe the therapeutic effect of granulocyte-monocyte colony stimulating factor (GM-CSF) as an adjuvant of yeast recombinant hepatitis B vaccine (rHBVac) on infants with HBV intrauterine infection. Methods: Five newborns with HBsAg (+) and HBV DNA> 1000copies / ml were enrolled in this study. The neonates were divided into two groups: the newborns in the treatment group were injected with 10 μg of intramuscular injection of hepatitis B vaccine 0,1,6 program), hepatitis B immunoglobulin 200IU buttocks intramuscular injection, once every 20 days, a total of 3 times, 3 days after the injection of hepatitis B vaccine the same part of the intradermal injection of GM-CSF 10μg / kg. The newborns in the control group were given 10 μg of intramyocardial injection of hepatitis B vaccine (0, 1, 6 regimen) after birth and hepatitis B immunoglobulin was intramuscularly injected every 200 IU, once every 20 days for 3 times. Hepatitis B was reexamined at the age of 1 month and HBsAg (+) was included in the study if HBsAg (-) was excluded. Both groups had 20 cases. Peripheral venous blood samples were taken at the age of 1 year to detect five items of HBV, changes of HBV DNA and levels of T lymphocyte subsets. Results: The HBsAg negative rate was 25.00% in 1-year-old infants and 5.00% in control infants with 1-year-old infants. There was no significant difference between the two groups (χ2 = 3.14, P> 0.05) The percentage of CD8 + in control group was lower than that in control group (t = 6.25, P <0.05), CD4 + / CD8 + ratio was higher than that in control group (t = 13.06, P <0.05) All were statistically significant (P <0.05). Conclusion: GM-CSF combined with hepatitis B vaccine and hepatitis B immunoglobulin have a therapeutic effect on HBV intrauterine infection.