大连市二价脊髓灰质炎减毒活疫苗安全性分析
|
摘要
目的分析二价脊髓灰质炎减毒活疫苗(bivalent oral live attenuated poliomyelitis vaccine,bOPV)、三价脊髓灰质炎减毒活疫苗(trivalent oral live attenuated poliomyelitis vaccine,t OPV)及脊髓灰质炎灭活疫苗(inactivated polio-virus vaccine,IPV)疑似预防接种异常反应(Adverse Events Following Immunization,AEFI)发生情况,评价bOPV安全性。方法收集大连市2009～2017年所有疫苗(包括第一类和第二类疫苗)的AEFI报告病例数和疫苗接种剂次,采用描述性流行病学方法进行统计分析。结果 bOPV发生AEFI 19例(男性8例,女性11例,男女发病比例为0. 73∶1),报告发生率为6. 88/10万,低于全部疫苗的平均报告发生率,高于t OPV,差异均有统计学意义(P <0. 05),与IPV-Salk相比,差异无统计学意义(P> 0. 05);11例发生在接种1 d内,7例发生在接种1 d后,1例发生在接种15 d后,其中一般反应18例,异常反应1例,发生严重异常反应的报告发生率为0. 36/10万,与全部疫苗和t OPV发生严重异常反应的报告发生率相比,差异无统计学意义(P> 0. 05)。结论 b OPV的AEFI发生率高于t OPV,低于全部疫苗,疫苗有较高的安全性。
Objective To compare the incidence rates of Adverse Events Following Immunization(AEFI)of bivalent oral live attenuated poliomyelitis vaccine(bOPV),trivalent oral live attenuated poliomyelitis vaccine(t OPV)and inactivated poliovirus vaccine(IPV)and evaluate the vaccine safety. Methods Cases and doses of AEFI caused by all the vaccines(including those of classesⅠandⅡ)reported from 2009 to 2017 in Dalian City,Liaoning Province,China were collected and subjected to statistical analysis by descriptively epidemiologic method. Results Nineteen cases of AEFI caused by bOPV was reported,8 in males and 11 in females,indicating an incidence of 6. 88/100 000,which were significantly lower than the reported mean incidence of AEFI caused by all the vaccines but significantly higher than that by t OPV(each P < 0. 05),and showed no significant difference with that by IPV-Salk(P > 0. 05). Eleven cases appeared within1 d,while 7 cases 1 d and one case 15 d after vaccination,including 18 cases of general reaction and one case of abnormal reaction. The reported incidence rate of severe abnormal reaction was 0. 36/100 000,which showed no significant difference with those caused by all the vaccines and by t OPV(P > 0. 05). Conclusion The incidence rate of AEFI caused by bOPV was higher than that by t OPV and lower than that by all the vaccines,indicating a high safety.
Objective To compare the incidence rates of Adverse Events Following Immunization(AEFI)of bivalent oral live attenuated poliomyelitis vaccine(bOPV),trivalent oral live attenuated poliomyelitis vaccine(t OPV)and inactivated poliovirus vaccine(IPV)and evaluate the vaccine safety. Methods Cases and doses of AEFI caused by all the vaccines(including those of classesⅠandⅡ)reported from 2009 to 2017 in Dalian City,Liaoning Province,China were collected and subjected to statistical analysis by descriptively epidemiologic method. Results Nineteen cases of AEFI caused by bOPV was reported,8 in males and 11 in females,indicating an incidence of 6. 88/100 000,which were significantly lower than the reported mean incidence of AEFI caused by all the vaccines but significantly higher than that by t OPV(each P < 0. 05),and showed no significant difference with that by IPV-Salk(P > 0. 05). Eleven cases appeared within1 d,while 7 cases 1 d and one case 15 d after vaccination,including 18 cases of general reaction and one case of abnormal reaction. The reported incidence rate of severe abnormal reaction was 0. 36/100 000,which showed no significant difference with those caused by all the vaccines and by t OPV(P > 0. 05). Conclusion The incidence rate of AEFI caused by bOPV was higher than that by t OPV and lower than that by all the vaccines,indicating a high safety.
引文
[1]LI L J,REN H.Infectious diseases[M].8th ed.Beijing:People's Medical Publishing House,2013:50-55.(in Chinese)李兰娟,任红.流行病学[M].8版.北京:人民卫生出版社,2013:50-55.
[2]WHO.关于消灭脊髓灰质炎的10个事实[EB/OL].(2017-10-25)[2018-12-16].http://www.who.int/features/factfiles/polio/zh/.
[3]ZHANG L F,WEN N,CAO L S,et al.Comparison of poliomyelitis vaccine routine immunization data from different sources in 8 provinces(municipalities)in China[J].Chin J Vacc Immun,2015,21(4):400-404.(in Chinese)张丽芬,温宁,曹玲生,等.中国8个省(自治区)不同数据来源脊髓灰质炎疫苗常规免疫接种数据比较分析[J].中国疫苗和免疫,2015,21(4):400-404.
[4]LI H,DAI X Q,LI X F,et al.Analysis on safety of bivalent oral poliomyelitis attenuated live vaccine in Qingdao City[J].JCommunity Med,2018,16(17):1335-1340.(in Chinese)李菡,代晓琦,李晓帆,等.青岛市二价脊髓灰质炎减毒活疫苗安全性分析[J].社会医学杂志,2018,16(17):1335-1340.
[5]WHO.SAGE meeting of April 2017[EB/OL].(2018-4-25)[2018-12-16].http://www.who.int/immunization/sage/meetings/2017/april/presen-tations_background_docs/en/.
[6]国家卫生计生委.我国响应世卫组织决议实施脊灰疫苗免疫新策略[EB/OL].(2016-04-29)[2018-12-16].http://www.nhfpc.gov.cn/zhuz/xwfb/201604/8c760a934d5b4d41a81752915c58d304.shtml.
[7]World Health Organization.Global eradication of poliomyelitis by the year 2000[C].41st World Health Assembly,Resolution WHA41.28.Geneva,WHO:1988.
[8]WEN N,SU Q R,AN Z J,et al.Considerations and suggestions for polio vaccination strategies in China[J].Chin J Vacc Immun,2018,24(3):349-353.(in Chinese)温宁,苏琪茹,安志杰,等.中国脊髓灰质炎疫苗免疫策略的思考及建议[J].中国疫苗和免疫,2018,24(3):349-353.
[9]MORALES M,TANGER MANN R H,WASSILAK S G F.Progress toward polio eradication-worldwide 2015-2016[J].MMWR,2016,65(18):470-473.
[10]WHO.Polio eradication and endgame strategic plan 2013-2018[EB/OL].(2013-05-03)[2018-12-16].http://www.polioeradication.org/resourcelibrary/strategyandwork.aspx#sthash.Not2-wzVX.dpuf.2013-2.
[11]Meeting of the Strategic Advisory Group of Experts on immunization.November 2012-conclusions and recommendations[J].Wkly Epidemiol Rec,2013,88:1-16.
[12]SUN L,CONG Y L,WANG J H,et al.Adverse events following immunization of bivalent oral poliovirus vaccines in Hebei province:analysis on surveillance data[J].Chin J Public Health,2018,34(6):877-881.(in Chinese)孙丽,丛艳丽,王晶辉,等.二价脊灰疫苗疑似预防接种异常反应监测分析[J].中国公共卫生,2018,34(6):877-881.
[13]WANG S Q,ZHANG C,WANG L,et al.Suspected adverse events following immunization of poliomyelitis vaccines in Hubei province:analysis on surveillance data of 2015-2017[J].Chin J Public Health,2018,34(5):736-740.(in Chinese)王四全,张迟,王雷,等.2015-2017年湖北省脊髓灰质炎疫苗疑似预防接种异常反应监测分析[J].中国公共卫生,2018,34(5):736-740.
[14]XING L L,CAO L S.Poliomyelitis immunization status and progress[J].Chin J Vacc Immun,2018,24(2):243-248.(in Chinese)邢力莉,曹玲生.脊髓灰质炎疫苗接种现状与进展[J].中国疫苗和免疫,2018,24(2):243-248.
[15]YANG Y,XIAO D,HAN Y N,et al.Epidemiological investigation on a case caused by vaccine hypervariable poliovirus in Dalian City[J].Occup and Health,2018,33(24):3426-3428.(in Chinese)杨月,肖丹,韩一楠,等.大连市1例脊髓灰质炎疫苗高变株病例的流行病学调查与分析[J].职业与健康,2018,33(24):3426-3428.
[16]HAN Y N,YANG Y,LIN Q,et al.Analysis of suspected adverse events following immunization during 2011~2016 in Dalian City,Liaoning Province,China[J].Chin J Biologicals,2018,31(2):170-176.(in Chinese)韩一楠,杨月,林茜,等.大连市2011~2016年疑似预防接种异常反应监测分析[J].中国生物制品学杂志,2018,31(2):170-176.
[17]XU D S,LI K L,WU W D,et al.Adverse events following immunization in China,2016[J].Chin J Vacc Immun,2018,24(6):299-322.(in Chinese)许涤沙,李克莉,武文娣,等.中国2016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,2018,24(6):299-322.
[2]WHO.关于消灭脊髓灰质炎的10个事实[EB/OL].(2017-10-25)[2018-12-16].http://www.who.int/features/factfiles/polio/zh/.
[3]ZHANG L F,WEN N,CAO L S,et al.Comparison of poliomyelitis vaccine routine immunization data from different sources in 8 provinces(municipalities)in China[J].Chin J Vacc Immun,2015,21(4):400-404.(in Chinese)张丽芬,温宁,曹玲生,等.中国8个省(自治区)不同数据来源脊髓灰质炎疫苗常规免疫接种数据比较分析[J].中国疫苗和免疫,2015,21(4):400-404.
[4]LI H,DAI X Q,LI X F,et al.Analysis on safety of bivalent oral poliomyelitis attenuated live vaccine in Qingdao City[J].JCommunity Med,2018,16(17):1335-1340.(in Chinese)李菡,代晓琦,李晓帆,等.青岛市二价脊髓灰质炎减毒活疫苗安全性分析[J].社会医学杂志,2018,16(17):1335-1340.
[5]WHO.SAGE meeting of April 2017[EB/OL].(2018-4-25)[2018-12-16].http://www.who.int/immunization/sage/meetings/2017/april/presen-tations_background_docs/en/.
[6]国家卫生计生委.我国响应世卫组织决议实施脊灰疫苗免疫新策略[EB/OL].(2016-04-29)[2018-12-16].http://www.nhfpc.gov.cn/zhuz/xwfb/201604/8c760a934d5b4d41a81752915c58d304.shtml.
[7]World Health Organization.Global eradication of poliomyelitis by the year 2000[C].41st World Health Assembly,Resolution WHA41.28.Geneva,WHO:1988.
[8]WEN N,SU Q R,AN Z J,et al.Considerations and suggestions for polio vaccination strategies in China[J].Chin J Vacc Immun,2018,24(3):349-353.(in Chinese)温宁,苏琪茹,安志杰,等.中国脊髓灰质炎疫苗免疫策略的思考及建议[J].中国疫苗和免疫,2018,24(3):349-353.
[9]MORALES M,TANGER MANN R H,WASSILAK S G F.Progress toward polio eradication-worldwide 2015-2016[J].MMWR,2016,65(18):470-473.
[10]WHO.Polio eradication and endgame strategic plan 2013-2018[EB/OL].(2013-05-03)[2018-12-16].http://www.polioeradication.org/resourcelibrary/strategyandwork.aspx#sthash.Not2-wzVX.dpuf.2013-2.
[11]Meeting of the Strategic Advisory Group of Experts on immunization.November 2012-conclusions and recommendations[J].Wkly Epidemiol Rec,2013,88:1-16.
[12]SUN L,CONG Y L,WANG J H,et al.Adverse events following immunization of bivalent oral poliovirus vaccines in Hebei province:analysis on surveillance data[J].Chin J Public Health,2018,34(6):877-881.(in Chinese)孙丽,丛艳丽,王晶辉,等.二价脊灰疫苗疑似预防接种异常反应监测分析[J].中国公共卫生,2018,34(6):877-881.
[13]WANG S Q,ZHANG C,WANG L,et al.Suspected adverse events following immunization of poliomyelitis vaccines in Hubei province:analysis on surveillance data of 2015-2017[J].Chin J Public Health,2018,34(5):736-740.(in Chinese)王四全,张迟,王雷,等.2015-2017年湖北省脊髓灰质炎疫苗疑似预防接种异常反应监测分析[J].中国公共卫生,2018,34(5):736-740.
[14]XING L L,CAO L S.Poliomyelitis immunization status and progress[J].Chin J Vacc Immun,2018,24(2):243-248.(in Chinese)邢力莉,曹玲生.脊髓灰质炎疫苗接种现状与进展[J].中国疫苗和免疫,2018,24(2):243-248.
[15]YANG Y,XIAO D,HAN Y N,et al.Epidemiological investigation on a case caused by vaccine hypervariable poliovirus in Dalian City[J].Occup and Health,2018,33(24):3426-3428.(in Chinese)杨月,肖丹,韩一楠,等.大连市1例脊髓灰质炎疫苗高变株病例的流行病学调查与分析[J].职业与健康,2018,33(24):3426-3428.
[16]HAN Y N,YANG Y,LIN Q,et al.Analysis of suspected adverse events following immunization during 2011~2016 in Dalian City,Liaoning Province,China[J].Chin J Biologicals,2018,31(2):170-176.(in Chinese)韩一楠,杨月,林茜,等.大连市2011~2016年疑似预防接种异常反应监测分析[J].中国生物制品学杂志,2018,31(2):170-176.
[17]XU D S,LI K L,WU W D,et al.Adverse events following immunization in China,2016[J].Chin J Vacc Immun,2018,24(6):299-322.(in Chinese)许涤沙,李克莉,武文娣,等.中国2016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,2018,24(6):299-322.