中国2014年疑似预防接种异常反应信息管理系统监测数据分析

Analysis of Surveillance for Adverse Events Following Immunization in China,2014

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)2014年疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)信息管理系统(AEFI Information Management System,AEFIIMS)数据,评价中国AEFIIMS运转质量。方法通过中国AEFIIMS收集2014年发生的AEFI个案数据。通过中国免疫规划信息管理系统(National Immunization Program Information Management System,NIPIMS)收集疫苗接种数据。采用描述性流行病学方法进行分析。结果 2014年中国AEFIIMS共收到156 889例AEFI个案,比2013年增加了14.05%;共有2 901个县(区、市、旗,下同)有AEFI报告,占中国总县数的93.52%;48h内AEFI报告率为98.74%,在需要调查的AEFI中,48h内调查率为99.42%。东部、中部和西部地区报告AEFI例数之比为3.17∶2.18∶1;男、女性别比为1.39∶1;≤1岁占74.75%。AEFI估算报告发生率为29.76/10万剂,比2013年升高了16.25%;其中严重AEFI为0.18/10万剂、异常反应为1.87/10万剂、严重异常反应为0.12/10万剂。在不良反应中,一般反应以发热、红肿、硬结为主;异常反应以过敏性皮疹、血管性水肿、卡介苗淋巴结炎为主;不良反应主要发生在接种后2d内;99.02%病例治愈或好转。结论中国AEFIIMS运行良好,AEFI监测敏感性和质量稳步推进,无疫苗质量事故报告。西部地区部分省(自治区、直辖市)仍是监测薄弱地区,需要加大培训和指导力度,提高监测敏感性。

Objective To analyze adverse events following immunization（AEFI） data from the national AEFI Information Management System（AEFIIMS） in China（not including Hong Kong Special Administrative Region,Macao Special Administrative Region and Taiwan）,2014,and to evaluate the implementation of AEFIIMS.Methods AEFI data reported in 2014 were collected through AEFIIMS.Data reported in 2014 on vaccine doses administered were collected through the National Immunization Program Information Management System（NIPIMS）.Descriptive epidemiological methods were used in the study.Results 156 889 AEFI cases were collected in 2014,14.05% more than in 2013.A total of 2 901（93.52%） counties reported AEFI.Among cases reported,98.74% were reported within 48 h,and 99.42% of investigation-targeted cases were investigated within 48 h.The ratios of cases among eastern,middle and western areas were 3.17：2.18：1,and the male-female ratio was 1.39：1.Cases ≤1 year old accounted for 74.75%.The estimated AEFI incidence rate was 29.76 per 100 000 doses,16.25% more than in 2013,with 0.18,1.87 and 0.12 per 100 000 doses for serious AEFIs,rare vaccine reactions and serous rare vaccine reactions,respectively.The most common symptoms in common vaccine reactions were fever,local swelling and local indurations.The most common diagnoses in rare vaccine reactions were anaphylactic rash,angioedema and lymphadenitis of Bacilli Calmette-Guérin vaccine.Vaccine reactions usually occurred within 2d after vaccination.Among total cases,99.02% resolved or had improved.Conclusions The sensitivity of the national AEFIIMS was greatly increased nationwide,but it was still low in some western provinces.No vaccine quality related events were reported.It is necessary to strengthen training and supervision activities to improve the monitoring sensitivity.