利用比例报告比方法分析中国2011～2013年水痘减毒活疫苗上市后预防接种异常反应信号

发布时间：2018-03-16 22:19

本文选题：比例报告比　切入点：水痘减毒活疫苗　出处：《中国疫苗和免疫》2015年05期 　论文类型：期刊论文

【摘要】：目的侦测水痘减毒活疫苗(Varicella Attenuated Live Vaccine,Var V)预防接种异常反应信号。方法利用药物安全性信号侦测中不均衡分析常见的比例报告比(Proportional Reporting Ratio,PRR)方法,对2011~2013年中国疑似预防接种异常反应信息管理系统中报告发生的有明确诊断的Var V预防接种异常反应进行分析,检测其预防接种异常反应的信号。结果 20 078例有明确诊断的预防接种异常反应个案参与分析,其中Var V占5.02%。使用PRR方法提示三年Var V有2个可疑预防接种异常反应信号:过敏性休克和变应性喉头水肿。按年度分析,SDR信号持续存在:过敏性休克三年均出现,变应性喉头水肿在2012和2013年均出现;按年龄分析,2岁组2个信号均出现,2~6岁组仅出现过敏性休克信号,6岁未出现信号。结论接种Var V后发生过敏性休克和变应性喉头水肿在各国均有报道,在中国利用PRR方法发现的信号提示存在报告数量上的关联。是否是需要采取下一步行动,需要经过包括医学评估在内的严谨的信号筛选和评价过程。
[Abstract]:Objective to detect abnormal response signals of varicella Attenuated Live vaccine Var V in attenuated varicella vaccine. The abnormal response of Var V vaccination in China from 2011 to 2013 was analyzed. Results 20 078 cases of abnormal vaccination reaction with definite diagnosis participated in the analysis. Among them, Var V accounted for 5.02. PRR method was used to indicate that there were two abnormal immunoreaction signals in Var V for 3 years: anaphylactic shock and allergic laryngeal edema. Allergic laryngeal edema appeared in 2012 and 2013. According to the age analysis, the signal of anaphylactic shock appeared only in the group of 2 years old and the signal of anaphylactic shock in the group of 6 years old. Conclusion the occurrence of anaphylactic shock and allergic laryngeal edema after inoculation of Var V has been reported in all countries. In China, there is a quantitative correlation in the number of reports found using the PRR method. Whether it is necessary to take the next step is to undergo a rigorous signal screening and evaluation process, including medical evaluation.
【作者单位】：中国疾病预防控制中心免疫规划中心;
【分类号】：R186

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