目的 分析北京市丰台区严重预防接种异常反应(serious rare adverse reaction,SRAR)发生特征,评价疫苗的安全性和预防接种服务质量。 方法 通过中国免疫规划监测信息管理系统和中国疾病预防控制信息系统疑似预防接种异常反应(adverse event following immunization,AEFI)信息管理系统,收集2008-2011年丰台区报告的严重疑似预防接种异常反应(serious adverse event following immunization,SAEFI)中SRAR病例,采用描述流行病学方法对其进行分析。 结果 2008-2011年丰台区SAEFI报告率4.41/100万剂,其中SRAR报告发生率为2.32/100万剂,男性高于女性,本地户籍儿童与外地户籍儿童没有明显差异;涉及6种疫苗,70%(7/10)的反应发生在接种第1剂次疫苗;50%(5/10)的病例从发生到报告的时间≥1 d;除疫苗相关麻痹型脊髓灰质炎病例(vaccine-associated paralytic poliomyelitis,VAPP)留有残疾外,其他疫苗引起的异常反应病例预后良好,无后遗症出现。 结论 丰台区疫苗的安全性和预防接种服务质量良好,家长对AEFI了解不足,接种医生在接种疫苗前应注意详细询问受种者过敏史和近期健康状况,对受种者应进行必要体检,规范接种,做好接种后医学观察,以保证接种安全。
Objective To understand the incidence pattern of serious rare adverse reaction(SRAR) in Fengtai district, Beijing, and evaluate the safety of vaccines and the quality of immunization services. Methods The incidence data of SRAR in Fengtai from 2008 to 2011 were collected through national immunization surveillance system to conduct descriptive epidemiological analysis. Results The reported incidences of serious AEFI and SRAR were 4.41/ million doses and 2.32/million doses, respectively. The SRAR incidence in males was higher than in females. Six categories of vaccine were involved. Up to 70% of SRAR occurred following the first dose vaccination, and the intervals between onset and reporting of 50% of SRAR were >1 day. All the adverse reaction cases had good prognosis without sequelae except polio vaccine-associated paralytic poliomyelitis. Conclusion The analysis indicated that both the safety of vaccines and the quality of immunization services were satisfactory in Fengtai, but it is still necessary for vaccination providers to conduct health counsel and examination before immunization, standardize the vaccination practice and give follow up after immunization to reduce serious AEFI.