中国药物评价
中國藥物評價
중국약물평개
Chinese Journal of Drug Evaluation
2014年
2期
117-121,128
,共6页
武文娣%刘大卫%李克莉%许涤沙%叶家楷%郑景山%曹雷%曹玲生%袁平%王华庆%李黎
武文娣%劉大衛%李剋莉%許滌沙%葉傢楷%鄭景山%曹雷%曹玲生%袁平%王華慶%李黎
무문제%류대위%리극리%허조사%협가해%정경산%조뢰%조령생%원평%왕화경%리려
脑膜炎球菌疫苗%预防接种%不良反应
腦膜炎毬菌疫苗%預防接種%不良反應
뇌막염구균역묘%예방접충%불량반응
Meningococcal vaccine%Vaccination%Adverse vaccine reactions
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)2010~2012年脑膜炎球菌疫苗( meningococcal vac-cine,MenV)预防接种异常反应的发生特征,评价MenV上市后预防接种安全性。方法:通过全国疑似预防接种异常反应信息管理系统,收集截至2010~2012年接种MenV发生的不良反应个案数据,采用描述流行病学方法进行分析。结果:2010~2012年中国共报告MenV接种后发生预防接种不良反应27046例,其中异常反应1724例,占6.38%;一般反应25322例,占93.62%。根据2010~2012年中国免疫规划信息管理系统中接种监测数据估算,4种MenV疫苗的一般反应报告发生率在7.84~54.37/10万;异常反应报告发生率在0.62~1.93/10万。不良反应以首剂为主。常见的异常反应为过敏性皮疹、血管性水肿等过敏反应。结论:中国MenV上市后不良反应发生率均较低,在可接受的预期范围内。
目的:分析全國(未包括香港、澳門特彆行政區和檯灣地區,下同)2010~2012年腦膜炎毬菌疫苗( meningococcal vac-cine,MenV)預防接種異常反應的髮生特徵,評價MenV上市後預防接種安全性。方法:通過全國疑似預防接種異常反應信息管理繫統,收集截至2010~2012年接種MenV髮生的不良反應箇案數據,採用描述流行病學方法進行分析。結果:2010~2012年中國共報告MenV接種後髮生預防接種不良反應27046例,其中異常反應1724例,佔6.38%;一般反應25322例,佔93.62%。根據2010~2012年中國免疫規劃信息管理繫統中接種鑑測數據估算,4種MenV疫苗的一般反應報告髮生率在7.84~54.37/10萬;異常反應報告髮生率在0.62~1.93/10萬。不良反應以首劑為主。常見的異常反應為過敏性皮疹、血管性水腫等過敏反應。結論:中國MenV上市後不良反應髮生率均較低,在可接受的預期範圍內。
목적:분석전국(미포괄향항、오문특별행정구화태만지구,하동)2010~2012년뇌막염구균역묘( meningococcal vac-cine,MenV)예방접충이상반응적발생특정,평개MenV상시후예방접충안전성。방법:통과전국의사예방접충이상반응신식관리계통,수집절지2010~2012년접충MenV발생적불량반응개안수거,채용묘술류행병학방법진행분석。결과:2010~2012년중국공보고MenV접충후발생예방접충불량반응27046례,기중이상반응1724례,점6.38%;일반반응25322례,점93.62%。근거2010~2012년중국면역규화신식관리계통중접충감측수거고산,4충MenV역묘적일반반응보고발생솔재7.84~54.37/10만;이상반응보고발생솔재0.62~1.93/10만。불량반응이수제위주。상견적이상반응위과민성피진、혈관성수종등과민반응。결론:중국MenV상시후불량반응발생솔균교저,재가접수적예기범위내。
Objective:The study is to analyze the occurrence features of adverse vaccine reactions after the immunization of meningo -coccal vaccine (MenV) in China (not include Hong Kong, Macao and Taiwan) 2010-2012, and to evaluate the immunization safety re-lated to MenV.Methods:2010-2012 MenV adverse vaccine reaction data were collected through the national adverse events following im -munization ( AEFI ) information system.The descriptive methodology was used in the study.Results:27046 adverse vaccine reactions were collected in 2010-2012 from National AEFI Information System , in which, 1724(6.38%) cases were rare and more serious vaccine reactions, and 25322(93.62%) were common and minor vaccine reactions.According to the vaccination doses from National Immuniza-tioninformation system , the estimated reported incidence rate of common and minor vaccine reactions ,and rare and more serious vaccine reactions were7.84-54.37 per 100 000 doses and 0.62-1.93 per 100 000 doses, respectively.Adverse vaccine reactions mainly occurred after the first dose.The common diagnoses of rare and more serious vaccine reactions were anaphylactoid reactions , such as anaphylactic rash andangioedema.Conclusions:The reported incidence rate of vaccine reactions related to MenV was acceptable and less than the ex -pected.