中国2016年疑似预防接种异常反应监测数据分析Adverse events following immunization in China,2016
许涤沙,李克莉,武文娣,叶家楷,吉赛赛,郑景山,崔健,曹玲生,肖奇友
摘要(Abstract):
目的分析中国(未包括中国香港特别行政区、澳门特别行政区和台湾)2016年疑似预防接种异常反应(Adverse events following immunization,AEFI)的发生特征。方法通过中国免疫规划信息管理系统收集2016年发生的AEFI个案数据和疫苗接种数据,采用描述流行病学方法进行数据分析。结果 2016年中国共报告185 583例AEFI个案,男、女性别报告数之比为1.27∶1;≤1岁儿童占74.01%;一般反应占92.45%、异常反应占6.18%。68.51%的不良反应发生在接种后0d。AEFI总报告发生率为39.01/10万剂;一般反应、异常反应、严重异常反应报告发生率分别为36.06/10万剂、2.41/10万剂、0.16/10万剂。报告例数居前5位的异常反应为过敏性皮疹9 569例(2.01/10万剂)、血管性水肿347例(0.07/10万剂)、卡介苗淋巴结炎260例(1.50/10万剂)、热性惊厥236例(0.05/10万剂)、卡介苗局部脓肿123例(0.71/10万剂)。结论 2016年中国AEFI以一般反应为主,严重异常反应报告发生率极低。
关键词(KeyWords): 疑似预防接种异常反应;监测
基金项目(Foundation): 中国CDC公共卫生应急反应机制的运行(131031001000150001)
作者(Author): 许涤沙,李克莉,武文娣,叶家楷,吉赛赛,郑景山,崔健,曹玲生,肖奇友
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].2010-06-10.General Office of the Ministry of Health,General Office of the State Food and Drug Administration.National guideline for surveillance of adverse events following immunization[S].2010-06-10.
- [2]国家卫生和计划生育委员会办公厅.预防接种工作规范(2016年版)[S].2016-12-06.General Office of the National Health and Family Planning Commission.Standard operation procedures for immunization(2016edition)[S].2016-12-06.
- [3]卫生部.预防接种异常反应鉴定办法[S].2008-09-11.Ministry of Health.Identification methods of adverse events following immunization[S].2008-09-11.
- [4]叶家楷,李克莉,许涤沙,等.中国2015年疑似预防接种异常反应监测分析[J].中国疫苗和免疫,2017,23(5):481-492,511.YE Jiakai,LI Keli,XU Disha,et al.Surveillance of adverse events following immunization in China,2015[J].Chinese Journal of Vaccines and Immunization,2017,23(5):481-492,511.
- [5]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 Wendi,LIU Dawei,LI Keli,et al.Analysis on adverse events following immunization surveillance in China,2009[J].Chinese Journal of Vaccines and Immunization,2011,17(2):99-108.
- [6]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 Wendi,LIU Dawei,LI Keli,et al.Analysis on adverse events following immunization surveillance in China,2010[J].Chinese Journal of Vaccines and Immunization,2012,18(5):385-397.
- [7]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 Wendi,LIU Dawei,LI Keli,et al.Analysis on surveillance data of adverse events following immunization in China,2011[J].Chinese Journal of Vaccines and Immunization,2013,19(2):97-109.
- [8]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):1-12,66.WU Wendi,LIU Dawei,LI Keli,et al.Analysis on surveillance data of adverse events following immunization in China,2012[J].Chinese Journal of Vaccines and Immunization,2014,20(1):1-12,66.
- [9]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):121-131,200.YE Jiakai,LI Keli,XU Disha,et al.Evaluation of the adverse events following immunization information management system in China,2013[J].Chinese Journal of Vaccines and Immunization,2015,21(2):121-131,200.
- [10]叶家楷,李克莉,许涤沙,等.中国2014年疑似预防接种异常反应信息管理系统监测数据分析[J].中国疫苗和免疫,2016,22(2):125-137.YE Jiakai,LI Keli,XU Disha,et al.Analysis of surveillance for adverse events following immunization in China,2014[J].Chinese Journal of Vaccines and Immunization,2016,22(2):125-137.
- [11]MAHAJAN D,DEY A,COOK J,et al.Surveillance of adverse events following immunisation in Australia annual report,2013[J].Commun Dis Intell,2015,30(3):E369-386.
- [12]DEY A,WANG H,QUINN H,et al.Surveillance of adverse events following immunisation in Australia annual report,2014[J].Commun Dis Intell,2016,40(3):E377-390.
- [13]DEY A,WANG H,QUINN H,et al.Surveillance of adverse events following immunisation in Australia annual report,2015[J].Commun Dis Intell,2017,41(3):E264-278.
- [14]ZHOU W,POOL V,ISKANDER JK,et al.Surveillance for safety after immunization:Vaccine Adverse Event Reporting System(VAERS)-United States,1991-2001[J].MMWR Surveill Summ,2003,52(1):1-24.
- [15]MILLER ER,SURAGH T,HIBBS B,et al.Chapter 21:Surveillance for adverse events following immunization using the Vaccine Adverse Event Reporting System(VAERS)[M]//ROUSH SW,BALDY LM.Manual for the surveillance of vaccine-preventable diseases.6th edition.Atlanta:2013:1-11.
- [16]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.
- [17]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.
- [18]WPRO.Vaccine reactions[M]//Immunization safety surveillance:guidelines for immunization programme managers on surveillance of adverse events following immunization.Third edition.Manila:WPRO Publication Office,2015:10-16.
- [19]WHO.Vaccine reaction rates information sheets on diphtheria,tetanus and pertussis vaccines[EB/OL].http://www.who.int/vaccine_safety/initiative/tools/DTP_vaccine_rates_information_sheet.pdf?ua=1.
- [20]WHO.Vaccine reaction rates information sheets on pneumococcal vaccine[EB/OL].http://www.who.int/vaccine_safety/initiative/tools/Pneumococcal_Vaccine_rates_information_sheet.pdf?ua=1.
- [21]WHO.Vaccine reaction rates information sheets on hepatitis B vaccine[EB/OL].http://www.who.int/vaccine_safety/initiative/tools/Hep_B_Vaccine_rates_information_sheet.pdf?ua=1.
- [22]BOHLKE K,DAVIS RL,MARCY SM,et al.Risk of anaphylaxis after vaccination of children and adolescents[J].Pediatrics,2013,112(4):815-820.
- [23]MCNEIL MM,WEINTRAUB ES,DUFFY J,et al.Risk of anaphylaxis after vaccination in children and adults[J].J Allergy Clin Immunol,2016,137(3):868-878.