中国2010年疑似预防接种异常反应监测数据分析Analysis on Adverse Events Following Immunization Surveillance in China, 2010
武文娣,刘大卫,李克莉,许涤沙,郑景山,曹玲生,曹雷,袁平,王华庆
摘要(Abstract):
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)2010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3月13日报告的2010年AEFI个案数据,采用描述性方法进行流行病学分析。结果全国2010年AEFI信息管理系统共收到56001例个案,严重AEFI1368例,非严重AEFI54633例。全国除西藏自治区外,各省(自治区、直辖市,下同)均有AEFI数据报告,共2561个县有数据报告,报告县比例为82.88%。48h内报告率为95.35%,48h内调查率为98.72%。AEFI报告数≤1岁占63.43%;男、女性别比为1.41∶1;集中在第三季度。AEFI分类率为99.72%。主要疫苗的严重AEFI估算报告发生率在0.54/100万剂~31.08/100万剂;非严重AEFI报告发生率在11.45/100万剂~1494.38/100万剂。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、无菌性脓肿、卡介苗淋巴结炎、过敏性紫癜和血管性水肿为主。不良反应主要集中在接种后≤1d。不同疫苗的预防接种异常反应估算报告发生率为:全身播散性卡介苗感染0.24/100万剂;疫苗相关麻痹型脊髓灰质炎0.21/100万剂;百日咳-白喉-破伤风联合疫苗无菌性脓肿6.55/100万剂;麻疹减毒活疫苗过敏性紫癜0.25/100万剂,血小板减少性紫癜0.03/100万剂;麻疹-流行性腮腺炎-风疹联合减毒活疫苗过敏性紫癜0.84/100万剂;乙型肝炎疫苗过敏性休克0.07/100万。在所有AEFI中,治愈和好转占98.07%,死亡129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,但各省差异较大;AEFI常发生在小年龄儿童和接种后≤1d;国家免疫规划疫苗不良反应报告发生率均在预期发生范围内。
关键词(KeyWords): 疑似预防接种异常反应;监测
基金项目(Foundation):
作者(Author): 武文娣,刘大卫,李克莉,许涤沙,郑景山,曹玲生,曹雷,袁平,王华庆
参考文献(References):
- [1]卫生部,国家食品药品监督管理局.全国疑似预防接种异常反应监测方案[S].2009-06-03.Minister of Health of China,State Food and Drug Administration of China.National Adverse Events Following Immunization Surveillance Guideline[S].2010-06-03.
- [2]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.
- [3]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.
- [4]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,2007,13(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.
- [5]WPRO.Immunization Safety surveillance:Guidelines for managers of immunization programmes on reporting and investigating adverse events following immunization[S].Philippines,Manila,1999.
- [6]刘大卫,郭飚,曹玲生,等.吸附无细胞和全细胞百白破联合疫苗上市后预防接种安全性的比较分析[J].中国疫苗和免疫,2008,14(2):97-102.LIU Da-wei,GUO Biao,CAO Ling-sheng,et al.Comparative Study on Post-Marketing Immunization Safety of Absorbed Diphtheria,Tetanus and Acellular Pertusis Combined Vaccine,and Absorbed Diphtheria,Tetanus and Whole-cell Pertusis Combined Vaccine in China[J].Chinese Journal of Vaccines and Immunization,2008,14(2):97-102.
- [7]许涤沙,刘大卫,李克莉,等.全国2005~2009年乙型肝炎疫苗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):109-117.XU Di-sha,LIU Da-wei,LI Ke-li,et al.Analysis on Surveillance of Adverse Events Following Immunization for Hepatitis B Vaccine in China,2005-2009[J].Chinese Journal of Vaccines and Immunization,2011,17(2):109-117.
- [8]刘大卫,郭飚,曹玲生,等.流行性乙型脑炎减毒活疫苗和灭活疫苗上市后预防接种安全性的比较分析[J].中国疫苗和免疫,2008,14(4):292-296.LIU Da-wei,GUO Biao,CAO Ling-sheng,et al.Comparative Studyon Post-marketing Immunization Safety of Live Japanese Encephalitis Vaccine and Inactivated Japanese Encephalitis Vaccine in China[J].Chinese Journal of Vaccines and Immunization,2008,14(4):292-296.
- [9]武文娣,刘大卫,李克莉,等,全国2005~2009年麻疹减毒活疫苗疑似预防接种异常反应监测数据分析[J].中国疫苗和免疫,2010,16(4):310-316.WU Wen-di,LIU Da-wei,LI Ke-li,et al.Analysis on Adverse Events Following Immunization Surveillance of Measles Attenuated Live Vaccine in China,2005-2009[J].Chinese Journal of Vaccines and Immunization,2010,16(4):310-316,339.
- [10]WHO.Supplementary information on vaccine safety,part2:background rates of adverse events following immunization[S].Swiss,Geneva,2000.
- [11]S E Tarvin,S Ballinger.Henoch-Schonlein purpura[J].Current Paediatrics,2006,16,259-263.
- [12]J M M Gardner-Medwin,P Dolezalova,C Cummins,et al.Incidence of Henoch-Sch nlein purpura,Kawasaki disease,and rare vasculitides in children of different ethnic origins[J].Lancet,2002,360:1197-1202
- [13]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-Sch nlein Purpura Cases in6Cities in China,2007-2009[J].Chinese Journal of Vaccines and Immunization,2011,17(2):128-132.
- [14]胡群.特发性血小板减少性紫癜诊断中的相关问题[J].实用儿科临床杂志,2010,25(3):159-161.HU Qun.Diagnosis of Idiopathic Thrombocytopenic Purpura in Children[J].J App l Clin P ediatr,2010,25(3):159-161.
- [15]李克莉,刘大卫,武文娣,等.2007~2009年中国六个市血小板减少性紫癜住院病例发生情况分析[J].中国疫苗和免疫,2012,18(2):147-153LI Ke-li,LIU Da-wei,WU Wen-di,et al.Study on the Incidence of Hospitalized Thrombocytopenic Purpura Cases in6Cities in China[J].Chinese Journal of Vaccines and Immunization,2012,18(2):147-153.
- [16]郭玉璞,王维治.神经病学[M].北京:人民卫生出版社,2006:364-378.GUO Yu-pu,WANG Wei-zhi.Neurology[M].Beijing:People’s Medical Publishing House,2006:364-378.
- [17]Haber P,DeStefano F,Angulo F J,et al.Guillain-Barrésyndrome following influenza vaccination[J].AM MED ASSOC,2004,292(20):2478-2481.
- [18]Tetsuo N,Kazumasa O.Vaccine adverse events reported in post-marketing study of the Kitasato Institute from1994to2004[J].Vaccine,2007,25(3):570-576.
- [19]James J,Sejvar,Katrin S,et a1.Encephalitis,myelitis,and acute disseminated encephalomyelitis(ADEM):Case definitions and guidelines for collection,analysis,and presentation of immunization safety data[J].OriginalResearchArticle,2007,25(31):5771-5792.