比例失衡法在甲型H1N1流感疫苗不良反应信号挖掘中的应用与分析  

Proportional imbalance in the mining of adverse reaction signals for influenza A H1N1 flu vaccine

作　　者：武雪 邓虹 陈力[1,2,3] WU Xue;DENG Hong;CHEN Li(Department of Pharmacy,West China Second University Hospital,Sichuan University,Chengdu 610041;Evidence-Based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu 610041;Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University),Ministry of Education,Chengdu 610041)

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

出　　处：《中南药学》2019年第6期806-810,共5页Central South Pharmacy

基　　金：四川省科技厅项目(No.2019JDR0163)

摘　　要：目的通过对甲型H1N1流感疫苗不良反应的信号挖掘分析,为临床合理安全用药提供参考。方法采用关于甲型H1N1流感疫苗的报告比值比法(ROR)和比例报告比值法(PRR)对美国FDA和CDC创建的疫苗不良反应事件报告系统(VAERS)2009年第一季度至2018年第四季度共40个季度的报告进行数据挖掘。结果使用ROR法共得到247个信号,二次筛选后得到73个信号,其中42个信号的不良反应未在甲型H1N1流感疫苗的说明书中出现。结论甲型H1N1流感疫苗不良反应发生频次较高的主要集中在中枢神经系统、皮肤、呼吸系统及胃肠系统等方面,其不良反应信号较强的主要集中在女性生殖系统、面部神经系统及呼吸系统等方面;也挖掘出疫苗说明书收录不全之处,如检测到甲型H1N1流感疫苗可能引起视觉损害、心率及心律紊乱、交感副交感神经损害和女性生殖系统损害等。建议临床用药时,应注意患者疾病的进展和中枢神经系统、皮肤、呼吸系统及胃肠系统的不良反应发生情况。Objective To provide a reference for clinical rational and safe drug use by signal mining analysis of adverse reactions of influenza A H1N1 flu vaccine. Methods Reported odds ratio (ROR) and proportional report ratio (PRR) for H1N1 flu vaccine were used for the data mining of vaccine adverse event reporting system (VAERS) by the US FDA and CDC, from the first quarter of 2009 to the fourth quarter of 2018, totalling 40 quarters. Results A total of 247 signals were obtained by the ROR method, and 73 signals were obtained after the secondary screening. The adverse reactions of 42 signals were not shown in the specification and label instruction of influenza A H1N1 flu vaccine. Conclusion The incidence of adverse reactions of influenza A H1N1 flu vaccine mainly appears in the central nervous system, the skin, the respiratory system and the gastrointestinal system. The adverse reaction signals mainly occur in the female reproductive system, the facial nervous system and the respiratory system. Incomplete collection of vaccine instructions is revealed, such as influenza A H1N1 flu vaccine may cause visual impairment, heart rate and heart rhythm disorders, sympathetic parasympathetic damage and female reproductive system damage. Doctors should pay attention to the progress of the patient disease and the occurrence of adverse reactions in the central nervous system, the skin, the respiratory system and the gastrointestinal system.

关 键 词：甲型H1N1流感疫苗 报告比值比法 比例报告比值法 不良反应信号 

分 类 号：R979.1[医药卫生—药品] R969[医药卫生—药学]