甲型H1N1流行性感冒病毒裂解疫苗的安全性研究  

Study on the Safety of Influenza A/H1N1 Split-virion Vaccine

作　　者：李瑞芳[1] 李建坡[1] 李琦[2] 张连山[1] 张富斌[2] 尹增慧 

机构地区：[1]河北省邯郸市疾病预防控制中心,河北邯郸056008 [2]河北省疾病预防控制中心 [3]河北省武安市疾病预防控制中心

出　　处：《实用预防医学》2012年第5期688-690,共3页Practical Preventive Medicine

摘　　要：目的评价甲型H1N1流行性感冒裂解疫苗(简称甲流疫苗)的安全性。方法设立主动监测点,通过全国疑似预防接种异常反应信息管理系统,收集全市接种甲流疫苗和主动监测点接种季节性流感疫苗后的AEFI个案信息,采用描述性方法对相关指标进行流行病学分析。结果邯郸市常规报告接种甲流疫苗后AEFI发生率14.64/10万,以一般反应为主,占88.57%,症状主要为38.5℃以下的低热,无严重不良反应和接种事故发生。主动监测点接种甲流疫苗后AEFI发生率752.63/10万,全部为一般反应,以发热为主。主动监测点接种季节性流感疫苗后AEFI发生率203.14/10万,全部为一般反应,均为发热。结论甲流疫苗接种后AEFI发生率高于季节性流感疫苗,但低于欧盟流感疫苗评价指标。甲流疫苗接种后AEFI反应类型以一般反应为主,且多为低热。甲流疫苗是安全的。Objective To evaluate the safety of influenza A/H1N1 split - virion vaccine. Methods Active surveillance sites were set up. AEFI cases with influenza A]H1N1 split - virion vaccine and seasonal influenza vaccine in Handan City were collected through National Surveillance System for Suspected Adverse Events Following Immunization （AEFI）. The related data were analyzed epidemiologically using descriptive methods. Results The incidence rate of reported AEFI cases with influenza A/HIN1 split-virion vaccine in Handan City was 14.64/100,000, and the general reactions were dominant, accounting for 88.57 %. The predominant symptom was fever below 38.5 degrees C. No serious adverse reactions and preventive inoculation ac- cidents occurred. The incidence rate of AEFI cases with influenza A/H1N1 split - virion vaccine reported by the surveillance sites was 752.63/100,000, all clinical symptoms were general reactions and the major manifestation was fever. The incidence rate of AEFI cases with seasonal influenza vaccine reported by the surveillance sites was 203.14[100,000, all clinical symptoms and the major manifestation were the same as above. Conclusions The incidence rate of AEFI cases with influenza A/H1N1 split- virion vaccine is higher than that of AEFI cases with seasonal influenza vaccine, but the rates are both lower than the EU stan- dards. General reactions dominate over AEFI cases with influenza A/H1N1 split - virion vaccine, and moreover, fever is the main manifestation. Influenza A/H1N1 split- virion vaccine is safe.

关 键 词：甲型H1N1流行性感冒裂解疫苗 预防接种 安全性 

分 类 号：R186[医药卫生—流行病学]