湖北省2010年疑似预防接种异常反应监测分析

Analysis on Adverse Events Following Immunization in Hubei Province in 2010

目的分析湖北省2010年疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)的发生特征,评价AEFI监测系统运转情况,以及国家免疫规划(National Immunization Program,NIP)疫苗的安全性和预防接种服务质量。方法通过中国疾病预防控制信息管理系统AEFI信息管理系统,收集湖北省2010年1月1日～12月31日的个案数据,采用描述性方法对相关指标进行流行病学分析。结果湖北省2010年报告AEFI1770例,县级报告覆盖率为100%。48h内报告率88.76%,48h内调查率97.74%,个案调查表完整率100%。1770例AEFI中,男、女性别比为1.41∶1,≤2岁儿童占77.46%。发生AEFI前五位的疫苗为麻疹减毒活疫苗、无细胞百日咳-白喉-破伤风(百白破)联合疫苗、全细胞百白破联合疫苗、A群脑膜炎球菌多糖疫苗、流行性乙型脑炎减毒活疫苗。在接种第1剂后发生AEFI的占65.42%;接种后≤1d发生的占84.18%。AEFI分类诊断中,不良反应占96.10%,其他占3.90%。在各种AEFI临床损害中,居前3位的依次为过敏反应、无菌性脓肿、卡介苗淋巴结炎。湖北省NIP疫苗预防接种异常反应报告发生率在0.28/100万剂～33.05/100万剂。结论湖北省2010年AEFI监测系统仍需提高监测质量。AEFI主要发生在小年龄组,NIP疫苗首剂接种后的1d内,是监测的重点。监测结果显示,湖北省NIP疫苗安全性和预防接种服务质量良好。

Objective To analyse the occurrence features of adverse events following immunization（AEFI） in Hubei province during 2010, so as to evaluate the operation status of AEFI monitoring system, and the safety of vaccines and vaccination services quality of national immunization programs （NIP）. Methods AEFI data were collected through the national information system of AEFI, which reported in Hubei from January 1st to December 31st, 2010. The epidemiological analysis on relevant index was conducted by descriptive methodology. Results The 1,770 cases of AEFI were reported in Hubei, in 2010, with 100% county coverage. The reported rate within 48h was 88.76%, the investigated rate within 48h was 97.74%, and the rate of completed investigation form was 100%. Among 1770 AEFI cases, the sex ratio of male and female was 1.41∶1, and children aged≤2 years accounted for 77.46%. AEFI in the top five vaccines were measles attenuated live vaccine, acellular pertussis, tetanus and diphtheria combined vaccine, diphtheria,tetanus, whole pertussis combined vaccine, group A meningococcal polysaccharide vaccine, and Japanese encephalitis attenuated live vaccine. The occurrence of AEFI after first dose and ≤1 day vaccination accounted for 65.42% and 84.18%, respectively. In AEFIclassification diagnosis, adverse reactions accounted for 96.10%, and other reactions accounted for 3.90%. In a variety of AEFI clinical impairment,allergic reactions, aseptic abscesses and Bacilli Calmette-Guerin vaccine （BCG） lymphadenitis were ranked in the top three. AEFI estimated reporting rate of NIP vaccines in Hubei were 0.28-25.43 per million. Conclusions The integrity and sensitivity of AEFI surveillance in Hubei were improved in 2010 than in the past years. However, AEFI monitoring quality should be improved further. AEFI occurred mainly in younger age groups after NIP vacines with the first dose within 1 day, which indicated that the younger age group is the priority group for monitoring. In addition, AEFI surveillance results showed that NIP vaccines were safety, and there was good service quality of vaccination in Hubei.