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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。
Objective To detect Varicella Attenuated Live Vaccine (Var V) vaccination against abnormal response signals. Methods Using the common PRR (Proportional Reporting Ratio) method for unbalanced analysis of drug safety signal detection, a clear diagnosis of Var V, which was reported in the information system of abnormal response of suspected vaccination in China from 2011 to 2013, Abnormal response to vaccination analysis, testing to prevent the abnormal signal response to vaccination. Results A total of 20 078 patients with definite diagnosis of vaccination abnormalities were involved in the analysis, among which Var V accounted for 5.02%. Three PRV methods were used to prompt Var V to have two suspicious vaccination abnormalities: allergic shock and allergic laryngeal edema. According to the annual analysis, SDR signal persisted: anaphylactic shock occurred for three years and allergic laryngeal edema occurred both in 2012 and 2013. According to the age analysis, two signals were observed in the group <2 years old, while the group 2 to 6 years old only Anaphylactic shock signal, no signal> 6 years old. Conclusion Anaphylactic shock and allergic laryngeal edema after Var V inoculation are reported in all countries. The signal found by PRR in China suggests that there is a correlation between the number of reports. Whether this is a need for further action requires rigorous signal screening and evaluation processes, including medical assessments.