基于真实世界的四价流感疫苗不良反应信号挖掘研究

Adverse Reaction Signals of Tetravalent Influenza Vaccine Based on Real World

目的挖掘四价流感疫苗的不良反应信号,为临床安全接种流感疫苗提供参考。方法利用报告比值比(ROR)法和比例报告比值比(PRR)法对美国疫苗不良事件报告系统(VAERS) 2013年至2018年的疫苗不良反应报告进行分析。结果 ROR法共得到222个信号,取信号较强的前50个不良反应信号,其中47个未在四价流感疫苗说明书中出现。结论四价流感疫苗的不良反应信号发生频次较高的集中在全身性损害,相关性较高的集中在肌肉与骨骼肌损害、中枢及外周神经系统损伤,尤其是颜面部外周神经损伤等。临床接种疫苗后,应及时关注接种者的面部外周神经损伤和肌肉骨骼肌损害的发生。

Objective To investigate the adverse reaction signals of tetravalent influenza vaccine,in order to provide reference for clinical safe vaccination of influenza vaccine. Methods Data analysis of adverse reaction signals of vaccines reported by Vaccine Adverse Event Reporting System( VAERS) in the United States from 2013 to 2018 was conducted by using reporting odds ratio( ROR) and proportional reporting ratio( PRR) methods. Results A total of 222 signals were obtained by ROR method,and the top 50 strong adverse reaction signals were included. Among them,47 did not appear in the instructions of tetravalent influenza vaccine. Conclusion The high frequency of adverse reaction signals of tetravalent influenza vaccine is concentrated in systemic damage,and the high correlation is concentrated in muscle and skeletal muscle damage,central and peripheral nervous system damage,especially facial peripheral nerve injury.After clinical inoculation,attention should be paid to the occurrence of facial peripheral nerve injury and musculoskeletal muscle injury.