采用2-1-1免疫程序接种狂犬病疫苗不同年龄段安全性评价

Safety assessment of different age groups using 2-1-1 vaccination

目的分析不同年龄的暴露后人群接种2-1-1程序辽宁成大速达水剂人用狂犬病疫苗的安全性。方法临床观察对象按照〈21岁,21~岁,≥51岁3个年龄组以1∶1∶1的比例各300人共900人随机分为观察组和对照组,观察组采用Zagreb 2-1-1方案4剂次免疫程序,对照组采用传统5剂次免疫程序接种狂犬病疫苗,比较两组对象整体及不同年龄段在疫苗接种后所有全身和局部症状的发生率的差异。结果在整体反应中,观察组疲倦乏力、触痛发生率较对照组低,且具有统计学意义（P〈0.05）,其余观察症状发生率对比无统计学意义;在不同年龄段的差异中,〈21岁年龄组中,观察组在发热、疲倦乏力、头晕、触痛、硬结、红肿的反应中与对照组发生率比较差异无统计学意义（P≥0.05）;21~岁年龄组中,观察组疲倦乏力、触痛发生率较对照组低,差异有统计学意义（P〈0.05）,其余观察症状发生率比较差异无统计学意义;≥51岁年龄组中观察组触痛发生率较对照组低,差异有统计学意义（P〈0.05）,其余观察症状发生率比较差异无统计学意义。结论采用Zagreb 2-1-1方案4剂次免疫程序接种辽宁成大速达人用狂犬病疫苗具有较高的临床安全性,值得推广。

Objective To assess the safety of 2-1-1 vaccination with Liaoning rabies vaccine for human in different age groups. Methods 300 individuals of each 〈21 years old, 21~ years old, and ≥51 years old age groups, a total of 900 people were randomly divided into the observation group and the control group. The observation group was vaccinated with 2-1-1 Zagreb protocol and the control group was vaccinated with 5 doses protocol with rabies vaccine. The incidence of systemic and local symptoms after vaccination in the two groups were compared. Results In the overall reaction,fatigue and tenderness occurrence rates of the observation group were significantly lower than those of the control group（P〈0.05）.There were no significant differences of other observed symptoms between two groups. The incidence of fever,fatigue, dizziness, tenderness, in duration, swelling of the reaction of the 〈21 years old age group showed no significant differences between the observation group and control group（P≥0.05）. In the 21-50 years old age group, the incidence of fatigue and tenderness were significantly lower than those of the control group（P〈0.05）, but showed no significant differences among the other observed symptoms. In the ≥51 year old age group, tenderness occurred rate of the observation group was significantly lower than that of the control group（P〈0.05）, but showed no significantly differences among other observed symptoms. Conclusion Using Zagreb 2-1-1 program for the 4 doses of vaccination of Liaoning rabies vaccine has a high clinical safety, and is worth promoting.