中国接种甲型H_1N_1流行性感冒疫苗后过敏性休克病例监测分析

Analysis on the Occurrence of Anaphylaxis Following Influenza A H_1N_1 Vaccine Immunization in China

目的分析中国(未包括香港、澳门特别行政区和台湾地区,下同)2009～2010年接种甲型H1N1流行性感冒(甲流)疫苗疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)中,过敏性休克的发生情况,评价接种甲流疫苗后过敏性休克的发生风险及监测处置情况。方法通过中国AEFI信息管理系统,收集2009年9月21日～2010年7月31日开展甲流疫苗接种活动后,截至2010年11月20日,全国甲流疫苗AEFI监测数据中过敏性休克个案信息,采用描述性方法进行流行病学分析。结果接种甲流疫苗期间,全国报告接种甲流疫苗后AEFI中过敏性休克50例,分类均为异常反应,报告发生率为0.50/100万剂次。其中20～59岁报告发生率为0.86/100万剂次,医务人员中报告发生率为2.87/100万剂次。接种至发生时间间隔中位数为10min(2～120min)。结论目前资料表明,接种甲流疫苗后发生过敏性休克极为罕见,未超过接种疫苗后过敏性休克的基础发生率;无证据表明接种甲流疫苗会增加过敏性休克的发生风险。

Objective To analyze the occurrence of anaphylaxis following Influenza A（H1N1）vaccine immunization in China during 2009-2010, and to evaluate the risk of anaphylaxis following immunization and the response to anaphylaxis. Methods Data on anaphylaxis following Influenza A（H1N1）vaccine immunization were collected through China AEFI information system by November 20, 2010. The number of doses administered was collected by reports from all provinces. The descriptive methodology was used in the study. Results 100.01 million doses were administered between September 21, 2009 and November 20, 2010, and 50 anaphylaxis cases（rate： 0.50 per million doses）were reported, with a hospitalization rate of 48.00%. The age-specific rates of anaphylaxis varied from each other, and the highest was 0.86 per million among persons aged from 20 to 59 years. The incidence rates of anaphylaxis among medical staff was 2.87 per million. The median interval from vaccination to onset was 10 minutes （range, 2-120 minutes）. Conclusions This study suggested that anaphylaxis was associated with influenza A（H1N1）vaccination, but the incidence was very low, which was under the baseline, and there was no evidence for an increase risk of anaphylaxis.