中国2015年疑似预防接种异常反应监测分析

Surveillance of adverse events following immunization in China,2015

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)2015年疑似预防接种异常反应(Adverse events following immunization,AEFI)监测质量和发生特征。方法通过中国免疫规划信息管理系统收集2015年发生的AEFI个案和疫苗接种数据,采用描述性流行病学方法进行分析。结果 2015年中国共报告154 223例AEFI;94.81%的县(区、市、旗)有AEFI报告;48h内报告率为98.80%;48h内调查率为98.29%。在报告病例中,男、女性别比为1.28:1;≤2岁占81.38%;东部、中部和西部地区分别占45.82%、36.06%、18.12%;98.06%的AEFI发生在接种后2d内;一般反应、异常反应分别占92.07%、6.61%。AEFI总估算报告发生率为29.74/10万剂;一般反应、异常反应、严重异常反应报告发生率分别为27.38/10万剂、1.97/10万剂、0.11/10万剂。异常反应主要为过敏性皮疹(8 202例,1.58/10万剂)、卡介苗淋巴结炎(343例,2.23/10万剂)、血管性水肿(331例,0.06/10万剂)、热性惊厥(212例,0.04/10万剂)、卡介苗局部脓肿(121例,0.79/10万剂)。结论 2015年中国AEFI监测敏感性和质量继续保持高水平。需继续加强尤其是中、西部薄弱地区AEFI监测管理和严重AEFI风险评估与处置工作。

Objective To analyze surveillance quality and characteristics of adverse events following immu- nization （AEFIs） in China （not including Hong Kong Special Administrative Region, Macao Special Ad- ministrative Region, and Taiwan）, 2015. Methods AEFI data reported in 2015 and vaccine doses admin- istered data were collected through the National Immunization Program Information Management System. Descriptive epidemiological methods were used for analyses. Results 154 223 AEFIs were reported in 2015, with 94. 81% of counties reporting cases; 98.80% of cases were reported within 48h; and 98. 29% of investigation-targeted cases were investigated within 48h. Among reported AEFIs, the male to female ratio was 1.28：1 ; 81.38% reports were children ≤2 years old; 45.82%, 36. 06%, and 18. 12% were re- ported from eastern, middle and western areas, respectively; 98.06% occurred within 2d after vaccination ; and 92. 07% and 6. 61% were common and rare vaccine reactions, respectively. The overall estimated AEFI incidence was 29. 74 per 100 000 doses, with 27.38, 1.97, and 0. 11 per 100 000 for common vac- cine reactions, rare vaccine reactions, and serous rare vaccine reactions, respectively. The most common rare reactions were anaphylactic rash （8 202, 1.58 per 100 000）, lymphadenitis following Bacilli Calmette- Gurrin vaccine （BCG） （343, 2. 23 per 100 000）, angioedema （331,0. 06 per 100 000）, febrile convulsion （212, 0. 04 per 100 000）, and local abscess following BCG （121,0. 79 per 100 000）. Conclusions The sensitivity and quality of AEFI surveillance continued to maintain a hiKh level in China. 2015. We should strengthen AEFI surveillance management, especially in middle and western areas, and risk assessment and responses to serious AEFIs.