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国产与美国 Merck 产的乙型肝炎疫苗在阻断 HBV 母婴传播中的效果比较

Comparison of Two Different Plasma-derived Vaccines in Prevention of Hepatitis B Virus

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【作者】 姚福宝李雪翔叶和清张绍美肖亮明杜玉霞吴文漪谢广中江圣寅陈松年孙景明

【Author】 Yao Fubao Shanghai Institute of Biological Products,Shanghai

【机构】 徐州医学院附属医院卫生部上海生物制品研究所徐州医学院附属医院

【摘要】 作者对 HBsAg 和 HBeAg 均阳性的孕妇所生婴儿分别用国产乙肝疫苗和美国 Merck产乙肝疫苗进行免疫。在12个月龄时,前者采血23例,HBsAg 阳性者5例。后者采血16例,HBsAg阳性者也是5例。保护率分别为75.9%和65.2%。12个月龄时的抗-HBs 阳性率国产乙肝疫苗和Merck 乙肝疫苗分别为77.3%和60.0%(X~2=0.3,P=0.4),GMT 各为544.2和470.0mIU/ml(X~2=0.3,P>0.05),两者均无显著性差异。

【Abstract】 Two batchs of vaccine,one produced by Shanghai Institute of Biological Products(Lot 8510,HBsAg 20μg/ml)and the other by Merck Sharpe and Dohme, USA(Lot 1061L,HBsAg 20μg/ml)were used.The first injection was given within the first 24h after delivery of the infants,the second and third injection at 1 and 6 months of age respectively. 37 infants born to hepatitis B surface antigen(HBsAg)and hepatitis B e antigen (HBeAg)positive mothers participated in this study.5 of 16 recipients who received Merck vaccine and 5 of 23 recipients who received Shanghai vaccine were converted to HBsAg positive at 12 months of age.The protective rates were 65.2% and 75.9% respectively.The anti-HBs cumulative seroconversion to the two vaccines at 12 mo- nths of age was 60.0% and 77.3% and the geometric mean titer(GMT)was 470.0 and 544.2 mIU/ml respectively. No significant difference was found between these two vaccines,produced by di- fferent manufacturers.

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