邯郸市大规模接种甲型H1N1流行性感冒病毒裂解疫苗的安全性观察

Investigation on the safety of mass vaccination influenza A H1N1 inactivated split influenza vaccine in Handan

目的评价甲型H1N1流行性感冒裂解疫苗(简称甲流疫苗)大规模接种的安全性。方法通过儿童预防接种信息管理系统和全国疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)信息管理系统,收集邯郸市2009年10月29日～2010年5月4日接种甲流疫苗个案信息和接种后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。结果邯郸市共接种甲流疫苗717 288人,发生AEFI 105例,发生率14.64/10万,其中不良反应102例(含一般反应93例、异常反应9例),偶合症2例,心因性反应1例,无严重不良反应和接种事故发生。一般反应中主要为发热61例(65.59%),且以38.5℃以下的低热为主(44例,70.97%)。报告AEFI有地区差异,无年龄和性别差异。报告AEFI主要在接种后24h内发生。3个生产企业生产的甲流疫苗的AEFI报告发生率差异有统计学意义(χ2=85.6,P单侧<0.01)。结论接种甲流疫苗后不良反应报告发生率低,无严重不良反应,较安全。接种后AEFI的发生与年龄、性别无关系。不同生产企业报告AEFI发生率差异有统计学意义。

Objective To evaluation the safety of mass vaccination influenza A H1N1 inactivated split influenza vaccine.Method According to national adverse events following immunization（AEFI） surveillance system and vaccination information management system,collecting the information of inoculation individual case and AEFI individual case form October 29,2009 to May 4,2010 and the information were analyzed by descriptive method.Results Total of 717 288 persons inoculated vaccine and 105 AEFI cases were reported with the incidence rate of 14.64/105,among them,102 cases were adverse reactions（93 were general reactions and 9 were paradoxical reaction）,2 coupling diseases and one psychogenic reaction,no serious adverse reactions and inoculation accidents occurred.Fever was the main general reaction symptoms,most of the patients were below 38.5℃（44 cases,70.97%）.Reported AEFI had regional disparity without age and sex differences.Most reported AEFI occurred within 24 hours after inoculation.The vaccine qualities of different manufacturers were different（χ^2=85.6,Punilateral〈 0.01）.Conclusions The influenza A H1N1 vaccine was safe and the incidence rate of AEFI was low,without serious adverse reaction.AEFI incidence rate had no statistically significant differences on ages and sex.The vaccines qualities of different manufacturers were not same.