上海市2007-2017年卡介苗疑似预防接种异常反应监测分析
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摘要
目的分析上海市2007-2017年卡介苗(Bacillus Calmette-Guérin vaccine,BCG)疑似预防接种异常反应(Adverse events following immunization,AEFI)的发生特征,评价BCG接种的安全性。方法通过中国AEFI信息管理系统收集2007-2017年接种BCG后发生的AEFI,进行描述性流行病学分析。结果 2007-2017年上海市共报告发生BCG AEFI 289例,总报告发生率为12. 20/10万剂,报告发生率从2011年的26. 37/万剂下降到2017年的7. 43/10万剂。在所有AEFI中,一般反应27例(1. 14/10万剂)、异常反应258例(10. 89/10万剂)、偶合症4例(0. 17/10万剂)。在异常反应中,BCG淋巴结炎211例(81. 78%,8. 91/10万剂),全身播散性BCG感染5例(1. 94%,0. 21/10万剂)。共报告重症不良反应8例,其中3例患有免疫缺陷性疾病。结论上海市2007-2017年BCG AEFI报告发生率有下降趋势,异常反应以BCG淋巴结炎为主,BCG安全性在预期范围内。
Objective To analyze characteristics of adverse events following immunization(AEFIs) with Bacillus Calmette-Guérin vaccine(BCG) in Shanghai during 2007-2017 and assess the safety of BCG vaccination. Methods We collected AEFI data related to BCG administration during 2007-2017 reported to the National AEFI Surveillance System and conducted descriptive epidemiological analyses. Results A total of 289 BCG AEFIs were reported during2007-2017 in Shanghai, for an incidence of 12.20 cases per 100 000 doses. The reported incidence dropped from 26.37 cases per 100 000 doses in 2011 to 7.43 cases per 100 000 doses in 2017. Among the AEFIs reported, 27(1.14 per100 000 doses) were common adverse reactions, 258(10.89 per 100 000 doses) were rare adverse reactions, and4(0.17 per 100 000 doses) were coincidental events. Among rare adverse reactions, 211(81.78%, 8.91 per 100 000 doses) were BCG lymphadenitis, and 5(1.94%, 0.21 per 100 000 doses) were disseminated BCG infection. Eight cases were identified as serious adverse reactions; 3 of these were among immunodeficient individuals. Conclusions The incidence of BCG AEFIs declined in Shanghai during 2007-2017. The most common rare adverse reaction was BCG lymphadenitis; the BCG safety profile was consistent with expectations.
Objective To analyze characteristics of adverse events following immunization(AEFIs) with Bacillus Calmette-Guérin vaccine(BCG) in Shanghai during 2007-2017 and assess the safety of BCG vaccination. Methods We collected AEFI data related to BCG administration during 2007-2017 reported to the National AEFI Surveillance System and conducted descriptive epidemiological analyses. Results A total of 289 BCG AEFIs were reported during2007-2017 in Shanghai, for an incidence of 12.20 cases per 100 000 doses. The reported incidence dropped from 26.37 cases per 100 000 doses in 2011 to 7.43 cases per 100 000 doses in 2017. Among the AEFIs reported, 27(1.14 per100 000 doses) were common adverse reactions, 258(10.89 per 100 000 doses) were rare adverse reactions, and4(0.17 per 100 000 doses) were coincidental events. Among rare adverse reactions, 211(81.78%, 8.91 per 100 000 doses) were BCG lymphadenitis, and 5(1.94%, 0.21 per 100 000 doses) were disseminated BCG infection. Eight cases were identified as serious adverse reactions; 3 of these were among immunodeficient individuals. Conclusions The incidence of BCG AEFIs declined in Shanghai during 2007-2017. The most common rare adverse reaction was BCG lymphadenitis; the BCG safety profile was consistent with expectations.
引文
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[4]李克莉,刘大卫,武文娣,等.2009~2010年全国卡介苗疑似预防接种异常反应监测分析[J].中国疫苗和免疫,2012,18(3):252-260+281.LI Kel i,LIU Dawei,WU Wendi,et al.Analysis on surveillance ofadverse events following immunization for Bacille Calmette-Guerin vaccine in China[J].Chinese Journal ofVaccines and Immunization,2012,18(3):252-260+281.
[5]谢广中,刁连东,王树巧,等.预防接种的反应和处理[M].第3版.上海:上海科学技术文献出版社,2009:113-115.XIE Guangzhong,DIAO Liandong,WANG Shuqiao,et al.Reactions after immunization and their responses[M].Third edition.Shanghai:Shanghai Scientific and Technological Publishers,2009:113-115.
[6]顾卓,薄祥国,吕广辉.接种卡介苗引起全身播散性结核死亡1例[J].中国计划免疫,2007,13(5):416+436.GU Zhuo,BO Xiangguo,LV Guanghui.Disseminated BCGinfection:one death report[J].Chinese Journal ofVaccines and Immunization,2007,13(5):416+436.
[7]李奕新,章国平,田建三,等.细胞免疫缺陷致全身播散性卡介苗感染死亡1例[J].中国防痨杂志,2008,30(5):489-490.LI Yi xin,ZHANG Guopin,TIAN J i a nsa n,e t a l.Disseminated BCG disease due to cell immune deficiency:one dea t h r epor t[J].The Jou r na l oft he Chinese Antituberculosis Association,2008,30(5):489-490.
[8]李文山,路艳.接种卡介苗引起全身播散感染和化脓性淋巴结炎死亡1例[J].中国疫苗和免疫,2010,16(4):377.LI Wenshan,LU Yan.Disseminated BCG infection and BCG lymphadenitis:one death report[J].Chinese Journal ofVaccines and Immunization,2010,16(4):377.
[9]徐尔迪,陈玺,肖延风.联合免疫缺陷病引起卡介苗接种后死亡1例及文献复习[J].中国儿童保健杂志,2012,20(8):767-768.XUN Er d i,CHEN Xi,XIAO Ya n feng.Combi n ed immu nodeficiency di s ease ca used fol lowing BCGvaccination:one death report and literature review[J].Chinese Journal ofChild Health Care,2012,20(8):767-768.
[10]尹洪云,马俊,何娅,等.住院儿童抗结核药物不良反应分析[C]//结核病和呼吸疾病诊治进展及治疗中肝损害专题研讨会资料汇编,2013-06,中国江西南昌,2013:85-90.YIN Hongyun,MA Jun,HE Ya,et al.Adverse reaction ofantituberculosis drugs among children inpatients[C]//Symposium on progress in diagnosis and treatment oftuberculosis and respiratory diseases and liver damage in treatment,2013-06,Nanchang,Jiangxi,China,2013:85-90.
[11]谢莉,高微微.抗结核药物不良反应临床分析[J].中国防痨杂志,2006,28(S1):50-51.XIE Li,GAO Weiwei.Cl i n ical analysis ofadverse reactions to antituberculosis drugs[J].The Journal ofthe Chinese Antituberculosis Association,2006,28(S1):50-51.
[12]王智璇.云南省322例抗结核药物不良反应研究[D].昆明:昆明医科大学,2013.WANG Zhixuan.Adverse reactions ofanti-tuberculosis drugs in 322 cases ofYunnan province[D].Kunming:Kunming Medical University,2013.
[13]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 ofMinistry ofHealth,General Office ofState Food and Drug Administration.National guideline for surveillance ofadverse events following immunization[S].2010-06-10.
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[15]BONIFACHICH E,CHORT M,ASTIGARRAGA A,et al.Protective effect ofBacillus Calmette-Guerin(BCG)vaccination in children with extra-pulmonary tuberculosis,but not the pulmonary disease:a case-control study in Rosario,Argentina[J].Vaccine,2006,24(15):2894-2899.
[16]CAMARGOS PA,GUIMARAES MD,ANTUNES CM.Risk assessment for acquiring meningitis tuberculosis among children not vaccinated with BCG:a case-control study[J].International Journal ofEpidemiology,1988,17(1):193.
[17]TRUNZ B B,FINE P,DYE C.Effect ofBCG vaccination on chi ld hood t u ber culous me n ingi t i s and mi l ia r y tuberculosis worldwide:a meta-analysis and assessment ofcost-effectiveness[J].Lancet,2006,367(9517):1173-1180.
[18]白庆瑞,胡家瑜,孙晓冬.上海市疑似预防接种异常反应监测系统的SWOT分析[J].中国疫苗和免疫,2016,22(4):433-437.BAI Qingrui,HU Jiayu,SUN Xiaodong A SWOT analysis ofthe surveillance system ofadverse events following immunization in Shanghai[J].Chinese Journal ofVaccines and Immunization,2016,22(4):433-437.
[19]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 Wendi,LIU Dawei,WU Bingbing,et al.Analysis on the surveillance ofadverse events following immunization in China,2007-2008[J].Chinese Journal ofVaccines and Immunization,2009,15(6):481-490.
[20]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 ofVaccines and Immunization,2011,17(2):99-108.
[21]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 ofVaccines and Immunization,2012,18(5):385-397.
[22]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,LI Keli,ZHENG Jingshan,et al.Analysis on adverse events following immunization surveillance in China,2011[J].Chinese Journal ofVaccines and Immunization,2013,19(2):97-109.
[23]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 Wend i,L IU Dawe i,L I Kel i,e t a l.Ana l ys i s on sur vei l lance da t a ofad ver se event s fol lowing immunization in China,2012[J].Chinese Journal ofVaccines and Immunization,2014,20(1):1-12+66.
[24]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 ofthe adverse events following immunizat ion informat ion management system in China,2013[J].Chinese Journal ofVaccines and Immunization,2015,21(2):121-131+200.
[25]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 J iaka i,LI Kel i,XU Disha,et a l.Ana lys is ofsurveillance for adverse events following immunization in China,2014[J].Chinese Journal ofVaccines and Immunization,2016,22(2):125-137.
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