人用狂犬病疫苗暴露后预防接种反应观察

Post-vaccination observation of human rabies vaccine

目的分析人用狂犬病疫苗(地鼠肾细胞)暴露后预防接种反应,并对其安全性做出评价。方法1 280例人用狂犬病疫苗(地鼠肾细胞)接种者,全程ESSEN免疫程序(暴露后D0、D3、D7、D14及D28于上臂三角肌肌内注射1剂疫苗)接种,观察接种后的全身反应(接种反应,adverse events)和局部接种反应情况,分别从性别、年龄、暴露等级及暴露动物等方面进行统计,分析其接种反应发生率及影响因素。结果接种人用狂犬病疫苗(地鼠肾细胞)的接种反应发生率为3.20%(41/1 280);局部反应中以疼痛为主,全身反应以疲劳乏力为主;第1针的接种反应发生率为3.05%(39/1 280),为5针中最高。所导致的接种反应者中,男性发生率为2.87%(19/662),女性发生率为3.56%(22/618);60岁以上年龄组的接种反应发生率为5.48%(8/146),为各年龄段最高;所有接种者中,Ⅱ级暴露的接种反应发生率为3.26%(33/1 012),在三种暴露等级中最高;发生接种反应者中,由犬伤暴露所致的发生率最高,为3.62%(34/940)。结论本研究中使用的人用狂犬病疫苗(地鼠肾细胞)接种反应较少,安全性较高。

Objective To evaluate the safety of the purified Hamster kidney cell rabies vaccine（PHKC）vaccinated after exposure under 5dose immune procedures. Methods A total of 1 280 cases inoculated with PHKCV at the upper arm deltoid intramuscular on D0,D3,D7,D14 and D28were recruited.Adverse events of systemic reactions and local adverse reactions were observed after vaccination.Statistical analysis was done for gender,age,exposure level and animal exposure to evaluate the incidence and risk factors of the adverse reactions. Results The overall adverse event rate vaccinated with PHKCV was 3.20%（41/1 280）with pain and fatigue are the most common side reactions.The rate of adverse events after the first injection was 3.05%（39/1 280）and highest at the five dose vaccination.Adverse events from males and females were 2.87%（19/662）and 3.56%（22/612）,respectively.The rate of adverse events was higher in category Ⅱ 3.26%（33/1 012）than that in categoryⅢ with the highest occurred in people above 60 years of old（8/146,5.48%）.Exposure to dog showed the highest adverse events 3.62%（34/940）in all animal exposures. Conclusions PHKC in our study showed high safety in the post exposure immunization.