福建省2012—2017年疑似预防接种异常反应监测分析

Adverse events following immunization in Fujian province,2012–2017:surveillance data analysis

目的分析福建省2012—2017年疑似预防接种异常反应(AEFI)的发生特征,为疫苗的安全使用提供科学依据。方法从国家疑似预防接种异常反应监测管理系统中收集2012年1月1日—2017年12月31日报告的福建省AEFI个案数据,从福建省免疫规划信息管理系统收集各种疫苗的接种剂次,采用描述性分析方法对AEFI分布特征和相关指标进行流行病学分析。结果 2012—2017年发生AEFI 12 778例,报告例数居前3位的为厦门市、福州市和泉州市,占全省报告数的47.89%。在时间上,2、3季度报告多于1、4季度。报告病例中,一般反应和异常反应分别占84.00%和14.09%,男女性别比为1.71∶1,≤2岁占83.80%。AEFI总估算发生率为15.06/10万剂次,报告发生率前3位的疫苗是无细胞百白破灭活脊灰和b型流感嗜血杆菌(结合)联合疫苗(Dap-IPV/Hib)54.52/10万剂、23价肺炎球菌多糖疫苗(PPV23)45.61/10万剂和A群C群脑膜炎球菌(结合)b型流感嗜血杆菌(结合)联合疫苗(MPV-AC/Hib)43.24/10万剂。80.83%的AEFI发生在接种后≤1 d,68.94%发生在第1剂次。一般反应以发热、红肿、硬结为主占85.27%;异常反应以过敏性皮疹为主。结论福建省各疫苗的AEFI发生率在预期范围内,监测系统的敏感性有待提高。

Objective To analyze the incidence and characteristics of adverse events following immunization (AEFI) in Fujian province from 2012 to 2017 and to provide evidences for vaccination safety. Methods We collected data on AEFI reported in Fujian province from January 1,2012 to December 31,2017 via National Immunization Program Information Management System and the data on yearly number of distributed doses of various vaccines in Fujian province from the individual immunization information system of Fujian province. Descriptive epidemiological method was used to analyze the distribution characteristics and related indicators of AEFI. Results Totally 12 778 AEFIs were reported in the province during the period;about a half (47.89%) of the AEFIs were reported in Quanzhou,Xiamen and Fuzhou municipality and more AEFIs were reported in the second and third quarter than in the first and fourth quarter of a year. Among the reported AEFIs,84.00% and 14.09% were common and rare vaccine reactions;the male to female ratio of the reported AEFIs was 1.71 : 1;and 83.80% of the reported AEFIs were small children aged ≤ 2 years. The overall estimated incidence rate of AEFI was 15.06 per 100 000 doses. The vaccines with the top first 3 estimated incidence rate of AEFI were diphtheria, tetanus and acellular pertussis,inactivated poliomyelitis and haemophilus influenzae type b conjugate combined vaccine (DTap-IPV/Hib,54.52 per 100 000 doses),23 valent pneumococcal polysaccharide vaccine (45.61 per 100 000 doses),and group A and C meningococcal and haemophilus type b conjugate vaccine (43.24 per 100 000 doses). Of the reported AEFIs, 80.83% occurred within one day after the vaccination and over three fifths (68.94%) occurred after the first dose vaccination. The most common symptoms for common reactions of the AEFIs were fever,local swelling and local indurations,while that for rare reactions was anaphylactic rash. Conclusion The reported incidences of AEFI for all vaccines were not high than the expected. The sensitivity of the AEFI surveillance system needs to be improved.