国产冻干人用狂犬病疫苗(Vero细胞)上市后安全性观察  

Post-marketing safety surveillance of Chinese freeze-dried rabies vaccine( Vero cell) for human use

作　　者：白云骅[1] 邵忆楠 杨立清[1] 李丽[1] 张彦利[1] 芦强[1] 张军楠[1] 张政[1] 李淑萍[1] Bai Yunhua;Shao Yinan;Yang Liqing;Li Li;Zhang Yanli;Lu Qiang;Zhang Junnan;Zhang Zheng;Li Shuping(Chaoyang District Center for Disease Control and Prevention, Beijing 100021, China;University of International Business and Economics, Beijing 100029, China)

机构地区：[1]北京市朝阳区疾病预防控制中心,北京100021 [2]对外经贸大学,北京100029

出　　处：《中国疫苗和免疫》2018年第3期319-322,共4页Chinese Journal of Vaccines and Immunization

摘　　要：目的评价国产冻干人用狂犬病疫苗（Vero细胞）用于动物致伤暴露后人群的安全性。方法在北京市、湖北省、湖南省选择11家狂犬病疫苗接种门诊,观察和收集2016-2017年动物致伤暴露人群接种5剂狂犬病疫苗后7d内的不良反应。结果 1 378名动物致伤暴露人群共接种狂犬病疫苗6 890剂次,总不良反应发生率为6.34%（437/6 890）,其中局部反应和全身反应发生率分别为1.94%（134例）和4.40%（303例）;1、2、3、4级不良反应发生率分别为5.73%（395例）、0.61%（42例）、0.00%、0.00%。第1-5剂不良反应发生率分别为15.46%（213例）、7.84%（108例）、6.24%（86例）、2.18%（30例）、0.00%。结论本研究中狂犬病疫苗的不良反应发生率低,疫苗安全性良好。Objective To evaluate through post-marketing surveillance the safety of Chinese freeze-dried rabies vaccine（ Vero cell） for human use among those injured by animals. Methods We selected 11 rabies vaccination clinics from Beijing city,Hubei province,and Hunan province to observe and collect data on adverse reactions within 7 days of completing a 5-dose schedule of rabies vaccine. Results Among 6 890 rabies vaccine doses administered to 1 378 people exposed to animal injury,the total incidence of adverse reactions was 6. 34%（ 437/6 890）; the rate of local reactions was 1. 94%（ 134 cases） and the rate of systemic reactions was 4. 40%（ 303 cases）; rates of grade 1,2,3,and 4 adverse reactions were5. 73%（ 395 cases）,0. 61%（ 42 cases）,0. 00%,and 0. 00%,respectively. The rates of adverse reactions to the first through fifth doses were 15. 46%（ 213 cases）,7. 84%（ 108 cases）,6. 24%（ 86 cases）,2. 18%（ 30 cases）,and 0. 00%,respectively. Conclusions The incidence of adverse reactions to rabies vaccine was low,showing a good vaccine safety profile.

关 键 词：狂犬病疫苗 安全性 

分 类 号：R186[医药卫生—流行病学]