两种不同剂型人用狂犬疫苗不良反应与免疫效果评价

目的:评价辽宁成大人用狂犬疫苗(水剂)和辽宁依生人用狂犬疫苗(冻干剂)的不良反应及免疫效果,为人用狂犬疫苗免疫接种提供参考依据。方法:采取随机抽样方法,选取狂犬病暴露后到预防医学门诊注射人用狂犬疫苗人群为对象。将入选对象随机分为A、B两组,分别接种辽宁成大人用狂犬疫苗(水剂)和辽宁依生人用狂犬疫苗(冻干剂),采用随机双盲方法观察接种疫苗后72 h不良反应发生率。使用宁波天润生物有限公司生产的人狂犬病毒IgG抗体测定试剂,采用间接ELISA法,检测人用狂犬疫苗注射后人血清中狂犬病毒IgG抗体。结果:不良反应发生率A组24.03%,B组8.82%,两组不良反应发生率的差异有统计学意义(χ2=8.65 P<0.01);抗体阳转率A组97.5%、B组97.6%,抗体阳转率差异无统计学差异(χ2=0.46 P>0.05)。结论:辽宁成大人用狂犬疫苗(水剂)和辽宁依生人用狂犬疫苗(冻干剂)相比较,辽宁依生人用狂犬疫苗(冻干剂)的不良反应率相对较小,为首选。

The Adverse Reaction and Immune Effect Evaluation of Two Different Formulations for Human Use Rabies Vaccine

Objective： To evaluate adverse reactions and immune effect of Liaoning cine （water aqua） and Liaoning rabies vaccine （lyophilized）, provides scientific basis for use rabies vaccine, methods： To take a random sampling medicine outpatient injection of human rabies post - exposure Cheng rabies vac- inoculating human method selected for the object that to preventive rabies vaccine crowd. The selected subjects were randomly divided into two groups （A, B） were inoculated Liaoning Cheng rabies vaccine （water aqua） and Liaoning rabies vaccine （lyophilized） in accordance with the stranger, randomized, double - blind method ob- served the incidence of adverse reaction after 72 hours. Use Ningbo Tianrun Biological, production rabies vi- rus IgG antibody assay reagent, using indirect ELISA for detection of human rabies virus IgG antibodies in the serum of the descendants of the rabies vaccination. Results： The adverse reactions incidence of group A is 24. 03%, group B is 8. 82%, the difference was statistically significant （x^2 =8. 65 P 〈0. 01 ）. Serocon- version rate in group A is 97.5%, group B is 97.6% ; seroconversion rate showed no statistically significant difference （x^2 = 0. 46 P 〉 0. 05 ）. Conclusion： Comparing Liaoning Cheng rabies vaccine （water aqua） with Liaoning （Lyophilized） rabies vaccine, adverse reaction rate of Liaoning （Lyophilized） rabies vaccine is smaller, as the first choice.