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目的探讨2种大剂量乙型肝炎(乙肝)疫苗对无应答成人再免疫的效果,为60μg/1.0 ml乙肝疫苗的临床应用提供依据。方法将有乙肝疫苗全程接种史、乙肝表面抗原(HBs A)g及乙肝表面抗体(抗-HBs)阴性的健康成人,根据知情同意、随机原则分为2组,1组为20μg组,即接种3针20μg乙肝疫苗,按“0、1、6”程序;1组为60μg组,即接种1针60μg乙肝疫苗。完成免疫程序后3个月内检测乙肝5项指标。结果无应答成人再免疫后,20μg组和60μg组2组抗-HBs阳转率约为88%,且正常应答者,2组抗-HBs几何平均滴度(GMT)水平相近,差异无统计学意义(P>0.05),低应答者,60μg组抗-HBs GMT高于20μg组(P<0.05)。男性抗-HBs阳转率较女性低(P<0.05),不同年龄组间抗-HBs阳转率差异无统计学意义(P>0.05)。结论 1针60μg/1.0 ml乙肝疫苗和3针20μg/ml乙肝疫苗疗效相当,可根据个体实际情况选择免疫方案。
Objective To investigate the effect of two high-dose hepatitis B (HBV) vaccines on non-responder adults and provide evidence for the clinical application of 60 μg / 1.0 ml Hepatitis B vaccine. Methods Healthy adults with history of hepatitis B vaccine inoculation, HBsAg and HBeAg negative were divided into two groups according to the principle of informed consent and randomization. The first group was 20μg group, which was vaccinated 3-pin 20μg hepatitis B vaccine, according to “0,1,6 ” program; a group of 60μg group, that is, a needle vaccination 60μg hepatitis B vaccine. Within 3 months after the completion of the immunization program, five indicators of hepatitis B were tested. Results After non-responder immunization, the positive rate of anti-HBs in 20μg and 60μg groups was about 88%, and the levels of anti-HBs geometric mean titers (GMTs) in normal responders and 2 groups were similar with no statistical difference Significance (P> 0.05), low responders, 60μg group anti-HBs GMT higher than 20μg group (P <0.05). The positive rate of anti-HBs in males was lower than that in females (P <0.05). There was no significant difference in the positive rate of anti-HBs among different age groups (P> 0.05). Conclusion The results showed that the 1-dose 60μg / 1.0ml Hepatitis B vaccine and the 3-dose 20μg / ml Hepatitis B vaccine have the same curative effect. The immunization program can be selected according to the actual situation of the individual.