基于VAERS的轮状病毒疫苗不良反应信号挖掘和数据分析  

Data analysis and signal excavation of rotavirus vaccine induced ADR based upon the VAERS

作　　者：刘砚韬[1,2,3] 林芸竹 陈力[1,2,3] 赵科 LIU Yan-tao;LIN Yun-zhu;CHEN Li;ZHAO Ke(West China Second University Hospital,Sichuan University,Department of Pharmacy,Sichuan Chengdu 610041,China;West China Second University Hospital,Sichuan University,Evidence-Based Pharmacy Center,Sichuan Chengdu 610041,China;West China Second University Hospital,Sichuan University,Key Laboratory of Birth Defects and Re-lated Diseases of Women&Children,Ministry of Education,Sichuan Chengdu 610041,China;Department of Pharmacy,West China School/Hospital of Stomatology Sichuan University,Sichuan Chengdu 610041,China)

机构地区：[1]四川大学华西第二医院药学部,四川成都610041 [2]四川大学华西第二医院循证药学中心,四川成都610041 [3]四川大学华西第二医院出生缺陷与相关妇儿疾病教育部重点实验室,四川成都610041 [4]四川大学华西口腔医院药剂科,四川成都610041

出　　处：《中国医院药学杂志》2021年第5期527-532,共6页Chinese Journal of Hospital Pharmacy

基　　金：四川省科学技术厅省级科技计划项目(编号:19RKX0513)。

摘　　要：目的:挖掘、评价轮状病毒疫苗上市后药物不良反应信号,为临床安全用药提供参考。方法:采用报告比值比法、比例报告比值比法、贝叶斯法对美国疫苗不良反应报告系统中的轮状病毒疫苗不良反应信号进行挖掘和分析。结果:纳入以轮状病毒疫苗为首要怀疑药品的不良反应(adverse drug reaction, ADR)报告15 417例,经ROR和PRR法检测得到可疑ADR信号359个,以ROR值大小排序排名前50位的ADR信号主要涉及系统为消化系统;采用BCPNN法对ROR值排名前25的可疑ADR进行重验获取结果为强信号的可疑ADR 11个;发掘出新的具有一定信号强度的ADR共130个。结论:通过对轮状病毒疫苗ADR信号挖掘,提示其发生消化系统不良反应风险较大,但仍需进一步信号评价和验证,以期为临床合理用药提供依据。OBJECTIVE To explore and evaluate the post-marketing adverse reaction signal of rotavirus vaccine and provide references for clinical safe medication.METHODS Reported odds ratio(ROR),proportional report ratio(PRR)and Bayesian analysis were employed for mining and analyzing the adverse reaction signal of rotavirus in FDA Vaccine Adverse Event Reporting System.RESULTS A total of 15 417 reports were largely induced by Rotavirus vaccine.A total of 359 signals correlated with decitabine were identified.The top 50 ADR signals sorted by the size of ROR were mostly correlated with digestive system.BCPNN method was utilized for retesting the suspicious ADRs with the top 25 ROR values for obtaining the suspicious ADRs with strong signals.A total of 130 new ADRs with sizable signal strength were discovered.CONCLUSION The ADR signal mining of rotavirus vaccine indicates that there is a higher risk of adverse reactions in digestive system.However, further signal evaluations and researches are required for providing references for safe clinical medication.

关 键 词：轮状病毒疫苗 药物不良反应 信号挖掘 

分 类 号：R967[医药卫生—药理学]