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国外免疫接种后不良事件因果关系评估方法简析

Analysis of the Methods Abroad of Causality of Adverse Events Following Immunization
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摘要 免疫接种不良事件(Adverse Events Following Immunization AEFI)因果评价方法是疫苗不良反应监测工作的重要内容。目前国际没有一种通用的关于疫苗与不良反应因果关系的评价方法。本文对世界卫生组织(WHO)安全顾问委员会、加拿大临床流行病学研究中心以及美国临床免疫评估协作网3个组织的免疫接种不良事件因果关系评价方法进行了介绍与分析,并对我国免疫接种后不良反应因果关系评估提出相关建议。 The method of causality assessment of Adverse Events Following Immunization (AEFI) is an important part for the vaccine adverse reaction monitoring and evaluation. At present there is not a normative method for causality assessment of AEFI internationaUy. This article introduced and analyzed three methods from the Global Advisory Committee on Vaccine Safety of WHO, Clinical Epidemiology Research Center of Canada, Clinical Immunization Safety Assessment of US. The suggestions were put forward for the work of causality assessment of AFEI.
出处 《中国药物警戒》 2014年第3期147-150,共4页 Chinese Journal of Pharmacovigilance
关键词 免疫接种不良事件 因果评价方法 adverse events following immunization method of causality assessment
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参考文献4

  • 1WHO.Causality assessment of adverse event following immunization [EB/OL].(2001-03-23)[2014-01-05].http://www.who.int/vaccine_ safety/cau sality/en/.
  • 2Collet J P, MacDonald N, Cashman N, et al.Cashman.Monitoring signals for vaccine safety:the assessment of individual adverse event report by an expert advisory committee[J].Bullentin of the World Health Organization,2000,78(2):178-185.
  • 3Williams S E, Pahud B A, Vellozzi C, et al. Causality assessment of serious neurologic adverse events following 2009 HIN1 vaccination[J]. Vaccine, 29 (46): 8302- 8308.
  • 4Kathleen Statton, Andrew Ford, Erin Rusch. Adverse effects of vaccines evidence and Causality[M].Washington,D.C, National Academies Press, 2012:10.

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