赤峰市5 073名暴露者接种冻干人用狂犬病疫苗(Vero细胞)的不良反应分析

Adverse reactions in 5 073 expose persons after immunization with freeze-dried rabies vaccine(Vero cells) for human use in Chifeng City,Inner Mongolia Autonomous Region,China

目的分析赤峰市5 073名暴露者接种冻干人用狂犬病疫苗(Vero细胞)后的不良反应。方法选取2018年4月—2019年4月期间赤峰市13个旗县5 073名狂犬病暴露者作为研究对象,收集接种冻干人用狂犬病疫苗(Vero细胞)后发热、乏力、接种部位红肿热痛等不良反应的发生情况,数据采用卡方检验进行统计分析。结果 5 073名暴露者接种冻干人用狂犬病疫苗(Vero细胞)后,共发生715例(占14.09%)不良反应,共接种21 823剂次,发生不良反应963例次,发生率为4.41%。不良反应以一般反应为主,主要表现为发热和接种部位红肿热痛;异常反应发生数较少,主要为过敏性皮疹。不良反应主要发生在0~10岁年龄组,发生率为20.61%,显著高于其他年龄组(P<0.001)。接种第1针次后共发生711例次不良反应,占比14.01%,显著高于其他针次(P<0.001)。结论5 073名暴露者接种冻干人用狂犬病疫苗(Vero细胞)后,以发热及接种部位的红肿热痛为主要不良反应,应着重观察和随访第1针次免疫后的儿童群体,降低不良反应给患者带来的伤害及风险。

Objective To analyze the adverse reactions in 5 073 expose persons after immunization with freeze-dried rabies vaccine(Vero cells)for human use in Chifeng City,Inner Mongolia Autonomous Region,China.Methods A total of 5 073 expose persons inoculated with freeze-dried rabies vaccine(Vero cells)for human use from April 2018 to April2019 in 13 counties in Chifeng City were selected as the research objects,of whom the adverse reactions such as fever,weakness as well as redness,swelling and hot pain in injection site were observed,and the obtained data were analyzed by Chi square test.Results Of the 5 073 expose persons,715 cases of adverse reactions were observed,indicating an incidence of 14.09%.However,of the 21 823 doses inoculated,adverse reactions were observed in 963(4.41%)doses.Most of the adverse reactions were general reactions,of which the main manifestations were fever as well as redness and hot pain in injection site.Few abnormal reactions were observed,which were mainly allergic skin rash.The adverse reactions mainly occurred in the recipients at ages of 0~10 years,of which the incidence(20.61%) was significantly higher than those in other age groups(P<0.001).Of the 956 cases of adverse reactions based on doses,711 cases occurred after the first dose,indicating a proportion of 14.01% which was significantly higher than those after the other doses(P<0.001).Conclusion The adverse reactions in 5 073 exposed persons after inoculation with freeze-dried rabies vaccine(Vero cells) for human use were mainly fever as well as redness,swelling and hot pain in injection site.The children after vaccination of the first dose should be observed and followed up emphatically so as to decrease the harm and risk of adverse reactions.