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目的分析全国(未包括香港、澳门特别行政区和台湾地区,下同)2011年疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)的发生特征,评价AEFI信息管理系统运转情况及预防接种安全性。方法通过全国AEFI信息管理系统,收集截至2012年12月24日报告的2011年发生的AEFI个案数据,用描述流行病学方法进行分析。结果全国2011年AEFI信息管理系统共收到76205例个案,比2010年增加了36.08%。全国共有2671个县(区、市、旗,下同)有数据报告,占总县数的86.27%;48h内报告率为97.17%,48h内调查率为98.91%。AEFI报告数男、女性别比为1.42:1,≤1岁占73.17%。根据中国2011年免疫规划信息管理系统中疫苗接种剂次估算,AEFI总发生率为15.56/10万剂,严重AEFI估算发生率为0.18/10万剂,预防接种异常反应估算发生率为1.27/10万剂。不良反应中,一般反应以发热、红肿、硬结为主,预防接种异常反应以过敏性皮疹、卡介苗淋巴结炎为主。不良反应主要集中在接种后≤1d。在所有AEFI中,治愈和好转占98.98%,死亡105例,其中预防接种异常反应17例。结论全国AEFI监测的敏感性有较大提高,但西部各省(自治区、直辖市)仍是薄弱地区;AEFI常发生在小年龄儿童和接种后≤1d;国家免疫规划疫苗预防接种异常反应报告发生率均在预期发生范围内。
Objective To analyze the occurrence characteristics of suspected AEFI in 2011 in the whole country (excluding Hong Kong, Macao Special Administrative Region and Taiwan, the same below), evaluate the operation of AEFI information management system and vaccination safety. Methods The AEFI case data collected in 2011 as of December 24, 2012 were collected through a national AEFI information management system and analyzed using descriptive epidemiological methods. Results A total of 76,205 cases were received by the nationwide AEFI information management system in 2011, an increase of 36.08% over 2010. A total of 2671 counties (districts, cities, and prefectures, the same below) reported data, accounting for 86.27% of the total counties in the country. The reporting rate was 97.17% within 48 hours and 98.91% within 48 hours. AEFI reported a number of male and female ratio of 1.42: 1, ≤ 1 year old accounted for 73.17%. According to the immunization schedule of immunization program information management system in China in 2011, the overall incidence of AEFI was 15.56 / 10 000, the incidence of severe AEFI was 0.18 / 100 000 and the incidence of vaccination anomalous response was 1.27 / 10 Ten thousand doses. Adverse reactions, the general reaction to fever, redness, induration, abnormal response to vaccination allergic rash, BCG-based lymphadenitis. Adverse reactions mainly concentrated after inoculation ≤ 1d. Among all AEFIs, 98.98% were cured and improved, and 105 died. Among them, 17 were abnormally vaccinated. Conclusion The sensitivity of AEFI surveillance in China is greatly improved, but western provinces (autonomous regions and municipalities directly under the Central Government) are still weak areas. AEFI often occurs in children with a small age and ≤1 days after inoculation. The incidence of abnormal immunization vaccine vaccination reports in both national immunization programs Within the expected range.