叶家楷,李克莉,许涤沙,武文娣,刘大卫,郑景山,曹雷,曹玲生,袁平,王华庆,李黎

• 1:中国疾病预防控制中心免疫规划中心

摘要(Abstract)：

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)2013年疑似预防接种异常反应信息管理系统(Adverse Events Following Immunization Information Management System,AEFIIMS)数据,评价中国AEFIIMS运转质量。方法通过中国AEFIIMS,收集截至2014年9月15日报告的2013年发生的AEFI个案数据,采用描述流行病学方法进行分析。结果中国2013年AEFIIMS共收到137 560例AEFI个案,比2012年增加了30.37%。中国共有2933个县(区、市、旗,下同)有AEFI报告,占总县数的94.58%;48小时内报告率为98.82%;在12 141例需要调查的AEFI中,48小时内调查率为99.46%。AEFI报告数东部、中部和西部地区之比为3.56∶2.58∶1;男、女性别比为1.39∶1;≤1岁占72.68%。2013年AEFI估算报告发生率为25.60/10万剂,其中严重AEFI 0.21/10万剂,预防接种异常反应1.66/10万剂,严重预防接种异常反应0.10/10万剂。在不良反应中,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。不良反应主要发生在接种后≤1天。在所有AEFI中,治愈和好转占99.08%。结论中国AEFIIMS敏感性有较大提高,但西部地区部分省(自治区、直辖市)仍是薄弱地区;AEFI以小年龄儿童为主,多数不良反应发生在接种后≤1天;预防接种异常反应估算报告发生率均在预期范围内。

关键词(KeyWords)： 疑似预防接种异常反应;监测

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 叶家楷,李克莉,许涤沙,武文娣,刘大卫,郑景山,曹雷,曹玲生,袁平,王华庆,李黎

参考文献(References)：

• [1]卫生部办公厅,国家食品药品监督管理局办公室.全国疑似预防接种异常反应监测方案[S].2010-06-03.General Office of the Ministry of Health,General Office of the State Food and Drug Administration of the People’s Republic of China.National Guideline for the Surveillance of Adverse Events Following Immunization[S].2010-06-03.
• [2]武文娣,刘大卫,李克莉,等.中国2012年疑似预防接种异常反应监测数据分析[J].中国疫苗和免疫,2014,20(1):1-12.WU Wen-di,LIU Da-wei,LI Ke-li,et al.Analysis on Adverse Events Following Immunization Surveillance in China,2012[J].Chinese Journal of Vaccines and Immunization,2014,20(1):1-12.
• [3]Weigong Zhou,Vitali Pool,John K Iskander,et al.Surveillance for safety after immunization:vaccine adverse event reporting system(VAERS)—United States,1991-2001[J].MMWR,2003,52(1):1-24.
• [4]Z Schumacher,C Bourquin,U Heininger.Surveillance for adverse events following immunization(AEFI)in Switzerland—1991-2001[J].Vaccine,2010,28(24):4059-4064.
• [5]Belkys M Galindo,Damarys Concepción,Miguel A Galindo,et al.Vaccine-related adverse events in Cuban children,1999-2008[J].MEDICC review,2012,14(1):38-43.
• [6]刘大卫,郭飚,曹玲生,等.全国2005~2006年疑似预防接种异常反应监测分析[J].中国计划免疫,2008,13(6):505-513.LIU Da-wei,GUO Biao,CAO Ling-sheng,et al.Study on the Surveillance of Adverse Events Following Immunization in China,2005-2006[J].Chinese Journal of Vaccines and Immunization,2007,13(6):505-513.
• [7]武文娣,刘大卫,吴冰冰,等.全国2007~2008年疑似预防接种异常反应监测分析[J].中国疫苗和免疫,2009,15(6):481-490.WU Wen-di,LIU Da-wei,WU Bing-bing,et al.Analysis on the Surveillance of Adverse Events Following Immunization in China,2007-2008[J].Chinese Journal of Vaccines and Immunization,2009,15(6):481-490.
• [8]武文娣,刘大卫,李克莉,等.全国2009年疑似预防接种异常反应监测分析[J].中国疫苗和免疫,2011,17(2):99-108.WU Wen-di,LIU Da-wei,LI Ke-li,et al.Analysis on Adverse Events Following Immunization Surveillance in China,2009[J].Chinese Journal of Vaccines and Immunization,2011,17(2):99-108.
• [9]武文娣,刘大卫,李克莉,等.中国2010年疑似预防接种异常反应监测数据分析[J].中国疫苗和免疫,2012,18(5):385-397.WU Wen-di,LIU Da-wei,LI Ke-li,et al.Analysis on Adverse Events Following Immunization Surveillance in China,2010[J].Chinese Journal of Vaccines and Immunization,2012,18(5):385-397.
• [10]武文娣,李克莉,郑景山,等.中国2011年疑似预防接种异常反应监测数据分析[J].中国疫苗和免疫,2013,19(2):97-109.WU Wen-di,LIU Da-wei,LI Ke-li,et al.Analysis on Adverse Events Following Immunization Surveillance in China,2010[J].Chinese Journal of Vaccines and Immunization,2013,19(2):97-109.
• [11]WHO&WPRO.Immunization safety surveillance:guidelines for immunization program managers on surveillance of adverse events following immunization(Second Edition)[S].Manila,Philippines,2013.
• [12]Department of Health.Vaccine safety and the mangement of adverse events following immunisation[S].Immunisation Against Infectious Disease,2006:53-64.
• [13]Anne D Walling,Gretchen Dickson.Guillain-BarréSyndrome[J].Am Fam Physician,2013,87(3):191-197.
• [14]马玉杰,高士锐,闫滨,等.黑龙江省吉兰-巴雷综合征和急性播散性脑脊髓炎发病率基线调查[J].中国公共卫生管理,2012,28(6):783-784.MA Yu-jie,GAO Shi-rui,YAN Bin,et al.Heilongjiang Province Green Guillain-BarréSyndrome and Acute Disseminated Encephalomyelitis Baseline Survey[J].Chinese Journal of Public Health Management,2012,28(6):783-784.
• [15]沈岩,高玉林,白法毅,等.石家庄市吉兰-巴雷综合征长期流行病学趋势兼与欧美趋势比较[J].中华流行病学杂志,1995,16(6):358.SHEN Yan,GAO Yu-lin,BAI Fa-yi,et al.The Long-term Epidemiological Trend of Guillain-BarréSyndrome and the Trend Comparison with Europe and America in Shijiazhuang[J].Chinese Journal of Epidemiology,1995,16(6):358.
• [16]李克莉,刘大卫,武文娣,等.中国六个市2007~2009年过敏性紫癜住院病例发病情况分析[J].中国疫苗和免疫,2011,17(2):128-132.LI Ke-li,LIU Da-wei,WU Wen-di,et al.Study on the Incidence of Hospitalized Henoch-Schonlein Purpura Cases in 6 Cities in China,2007-2009[J].Chinese Journal of Vaccines and Immunization,2011,17(2):128-132.
• [17]Farshid Noorbakhsh,Richard T.Johnson,Derek Emery,et al.Acute disseminated encephalomyelitis:clinical and pathogenesis features[J].Neurologic Clinics,2008,26(3):759-780.
• [18]武文娣,刘大卫,王亚敏,等.中国2009~2012年急性播散性脑脊髓炎疑似预防接种异常反应监测数据分析[J].中国疫苗和免疫,2014,20(1):26-30.WU Wen-di,LIU Da-wei,WANG Ya-min,et al.Analysis on Surveillance Data of Acute Disseminated Encephalomyelitis as Adverse Events Following Immunization in China,2009-2012[J].Chinese Journal of Vaccines and Immunization,2014,20(1):26-30.