序贯分析在疫苗上市后安全性动态监测中的应用  

The application of sequential analysis for continuous post-market vaccine safety surveillance

作　　者：卢子璇 李慕苏 潘嘉禾 吴怡雯 李会琳 郁尔 沃红梅[2] 唐少文 赵杨 戴俊程 易洪刚 Lu Zixuan;Li Musu;Pan Jiahe;Wu Yiwen;Li Huilin;Yu Er;Wo Hongmei;Tang Shaowen;Zhao Yang;Dai Juncheng;Yi Honggang(Department of Biostatistics,School of Public Health,Nanjing Medical University,Nanjing 211166,China;Department of Social Security,School of Health Policy and Management,Nanjing Medical University,Nanjing 211166,China;Department of Epidemiology,School of Public Health,Nanjing Medical University,Nanjing 211166,China)

机构地区：[1]南京医科大学公共卫生学院生物统计学系,南京211166 [2]南京医科大学医政学院社会保障系,南京211166 [3]南京医科大学公共卫生学院流行病学系,南京211166

出　　处：《中华流行病学杂志》2025年第3期514-518,共5页Chinese Journal of Epidemiology

基　　金：国家级大学生创新创业训练计划(202310312020Z);江苏省高等学校大学生创新训练计划(202410312175Y);江苏高校优势学科建设工程资助项目(应用统计学);江苏省品牌专业建设工程项目。

摘　　要：探讨序贯分析在疫苗上市后安全性动态监测中的应用,以疫苗上市后动态监测数据为例,介绍最大化序贯概率比检验和贝叶斯序贯分析的基本原理和R软件分析。通过疫苗上市后安全性动态监测数据实例,分别采用最大化序贯概率比检验和贝叶斯序贯分析2种方法进行分析,最大化序贯概率比检验结果表明,在第4周时出现安全性警戒信号(P<0.05);贝叶斯序贯分析结果表明,在第4周时RR值的95%最高密度区间为1.13~3.27,提示在第4周首次出现安全性警戒信号。最大化序贯概率比检验和贝叶斯序贯分析方法充分利用不断累积的动态监测数据信息,是疫苗安全性动态监测的有效方法。To explore the application of sequential analysis in post-market safety dynamic surveillance of vaccines.Under the dynamic monitoring data of vaccines post-market approval,this research introduces the fundamental principles of maximizing sequential probability ratio test(MaxSPRT)and Bayesian sequential analysis,employing R software.Through an example of dynamic safety monitoring data of vaccines post-market approval,we analyze using the MaxSPRT and Bayesian sequential analysis.The MaxSPRT identified a safety signal in week 4(P<0.05),while Bayesian sequential analysis indicated that the 95%highest density interval for the RR value at week 4 is 1.13-3.27,suggesting the first appearance of a safety signal at week 4.The MaxSPRT and Bayesian sequential analysis effectively leverage continuously accumulating dynamic monitoring data,thereby serving as a valuable method for post-market safety surveillance of vaccines.

关 键 词：安全性监测 不良事件 贝叶斯序贯分析 药物警戒 

分 类 号：S85[农业科学—兽医学]