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目的了解新生儿接种10微克(μg)重组乙型肝炎(乙肝)疫苗(汉逊酵母)[Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid(DNA)Techniques in Hansenula Polymorpha Yeast,Hep B-HPY)]和5μg重组Hep B(酿酒酵母,Saccharomyces Cerevisciae Yeast)(HepB-SCY)的安全性。方法选择本县医院产科出生的新生儿分为实验组与对照组,分别接种10μg Hep B-HPY和5μg HepB-SCY,观察两种HepB的安全性。结果 10μg HepB-HPY接种了13988剂,发生不良反应5例,其中1例为发热,3例为接种部位的红肿,1例为接种部位的硬结,不良反应总发生率为35.74/10万剂;5μg HepB-SCY接种了9058剂,发生不良反应4例,其中3例为发热,1例为接种部位红肿,不良反应总发生率为44.16/10万剂,两种HepB不良反应总发生率的差异无统计学意义(χ~2=0.752,P=0.745)。结论接种10μg HepB-HPY和5μg HepB-SCY均有良好的安全性。
Objective To investigate the effects of neonatal inoculation of 10 μg recombinant Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid (DNA) in Hansenula Polymorpha Yeast Hep B-HPY) and 5 μg recombinant Hep B (Saccharomyces Cerevisciae Yeast) (HepB-SCY). Methods Neonates were randomly divided into experimental group and control group. The HepB-SCY and HepB-SCY were inoculated with 10μg Hep B-HPY and 5μg HepB-SCY respectively. The safety of the two HepBs was observed. Results A total of 13988 doses of HepB-HPY were inoculated in 5μg / ml HepB-HPY. Five patients developed adverse reactions, including fever in one case, inflamed area in 3 cases and induration in 1 case. The total incidence of adverse reactions was 35.74 / 5μg HepB-SCY was inoculated with 9058 doses and 4 cases were adverse reactions, of which 3 were fever, 1 was inflamed at the site of vaccination, and the total incidence of adverse reactions was 44.16 / 10 000. The difference in the incidence of adverse reactions between the two HepBs No statistical significance (χ ~ 2 = 0.752, P = 0.745). Conclusion Inoculation of 10μg HepB-HPY and 5μg HepB-SCY all have good safety.