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,崔健,王华庆

• 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)2014年疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)信息管理系统(AEFI Information Management System,AEFIIMS)数据,评价中国AEFIIMS运转质量。方法通过中国AEFIIMS收集2014年发生的AEFI个案数据。通过中国免疫规划信息管理系统(National Immunization Program Information Management System,NIPIMS)收集疫苗接种数据。采用描述性流行病学方法进行分析。结果 2014年中国AEFIIMS共收到156 889例AEFI个案,比2013年增加了14.05%;共有2 901个县(区、市、旗,下同)有AEFI报告,占中国总县数的93.52%;48h内AEFI报告率为98.74%,在需要调查的AEFI中,48h内调查率为99.42%。东部、中部和西部地区报告AEFI例数之比为3.17∶2.18∶1;男、女性别比为1.39∶1;≤1岁占74.75%。AEFI估算报告发生率为29.76/10万剂,比2013年升高了16.25%;其中严重AEFI为0.18/10万剂、异常反应为1.87/10万剂、严重异常反应为0.12/10万剂。在不良反应中,一般反应以发热、红肿、硬结为主;异常反应以过敏性皮疹、血管性水肿、卡介苗淋巴结炎为主;不良反应主要发生在接种后2d内;99.02%病例治愈或好转。结论中国AEFIIMS运行良好,AEFI监测敏感性和质量稳步推进,无疫苗质量事故报告。西部地区部分省(自治区、直辖市)仍是监测薄弱地区,需要加大培训和指导力度,提高监测敏感性。

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,崔健,王华庆

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].中国疫苗和免疫,2011,17(1):72-82.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].Chinese Journal of Vaccines and Immunization,2011,17(1):72-82.
• [2]叶家楷,李克莉,许涤沙,等.中国2013年疑似预防接种异常反应信息管理系统数据分析[J].中国疫苗和免疫,2015,21(2):121-138,189.YE Jia-kai,LI Ke-li,XU Di-sha,et al.Analysis on Surveillance Data of Adverse Events Following Immunization Information Management System in China,2013[J].Chinese Journal of Vaccines and Immunization,2015,21(2):121-138,189.
• [3]Cheng DR,Perrett KP,Choo S,et al.Pediatric anaphylactic adverse events following immunization in Victoria,Australia from 2007to 2013[J].Vaccine,2015,33(13):1602-1607.
• [4]Deepika Mahajan AD,Jane Cook,Bronwen Harvey,et al.Annual report:surveillance of adverse events following immunisation in Australia,2012[J].Communicable Diseases Intelligence,2014,38(3):E232-E246.
• [5]Alicino C,Merlano C,Zappettini S,et al.Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety[J].Hum Vaccin Immunother,2015,11(1):91-94.
• [6]Miller ER,Haber P,Hibbs B,et al.Surveillance for adverse eventsfollowing immunization using the Vaccine Adverse Event Reporting System(VAERS)[M].Vaccine preventable disease surveillance manual.5th ed;2011,Chapter 21.http://cdc.gov/vaccines/pubs/surv-manual/chpt21-surv-adverse-events.pdf.
• [7]Loughlin AM,Marchant CD,Adams W,et al.Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System(VAERS)[J].Vaccine,2012,30(50):7253-7259.
• [8]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.
• [9]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.
• [10]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.
• [11]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.
• [12]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.
• [13]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.
• [14]Shimabukuro TT,Nguyen M,Martin D,et al.Safety monitoring in the Vaccine Adverse Event Reporting System(VAERS)[J].Vaccine,2015,33(36):4398-4405.
• [15]Moro PL,Arana J,Cano M,et al.Deaths Reported to the Vaccine Adverse Event Reporting System,United States,1997-2013[J].Clin Infect Dis,2015,61(6):980-987.
• [16]American Academy of Pediatrics Task Force on Sudden Infant Death Syndrome.The changing concept of sudden infant death syndrome:diagnostic coding shifts,controversies regarding the sleeping environment,and new variables to consider in reducing risk[J].Pediatrics,2005,116(5):1245-1255.
• [17]WHO.Global Manual on Surveillance of Adverse Events Following Immunization[S].2014
• [18]Bohlke K,Davis RL,Marcy SM,et al.Risk of anaphylaxis after vaccination of children and adolescents[J].Pediatrics,2003,112(4):815-820.
• [19]Souayah N,Yacoub HA,Khan HM,et al.Analysis of data from the CDC/FDA vaccine adverse event reporting system(1990-2009)on Guillain-Barre syndrome after hepatitis vaccination in the USA[J].J Clin Neurosci,2012,19(8):1089-1092.
• [20]马玉杰,高士锐,闫滨,等.黑龙江省格林-巴利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.
• [21]沈岩,高玉林,白法毅,等.石家庄市格林-巴利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.
• [22]Hao L TS,Kobayashi Y.Poisson-model analysis of the risk of vaccine-associated paralytic poliomyelitis in Japan between 1971-2000[J].Jpn J Infect Dis,2008,61(2):100-103.
• [23]Menge T,Kieseier BC,Nessler S,et al.Acute disseminated encephalomyelitis:an acute hit against the brain[J].Curr Opin Neurol,2007,20(3):247-254.
• [24]Noorbakhsh F,Johnson RT,Emery D,et al.Acute disseminated encephalomyelitis:clinical and pathogenesis features[J].Neurol Clin,2008,26(3):759-780.