HPV九价疫苗的不良事件信号挖掘与分析

Signal mining and analysis of the adverse reaction signals of nine-valent human papillomavirus vaccine

目的:通过对HPV九价疫苗的不良反应信号进行挖掘与分析,为选择接种疫苗提供安全性参考。方法:利用报告比值比法(ROR)和比例报告比值法(PRR)对美国疫苗不良事件报告系统(VAERS)2016-2019年共4年的不良事件报告进行数据挖掘,筛选出符合阈值的信号,采用国际医学用语词典(MedDRA)的首选系统器官分类(SOC)和首选术语(PT)进行统计和分类。结果:使用ROR法和PRR法均得到282个信号,相关报告数12491例,涉及24个SOC,PT报告数与信号数对应的SOC构成比居前3位的均为:各类损伤、中毒及操作并发症,各类神经系统疾病,各类检查。将符合阈值的PT按信号数与信号强度降序排列,分别筛选出排在前50位的PT,共得到84个PT信号,其中34个有信号的不良反应未在HPV九价疫苗说明书中提及,主要为生殖系统及乳腺疾病、各类神经系统疾病、精神病类、眼器官疾病、各种肌肉骨骼及结缔组织疾病。结论:HPV九价疫苗的不良反应信号主要集中在神经系统,针对挖掘出的新信号临床应引起重视,其相关性需要进一步的研究。

OBJECTIVE To explore and analyze the adverse reaction signals of HPV9-valent vaccine,which can provide a safety reference for the selection of vaccination vaccine.METHODS Reporting Odds Ratio(ROR)and Proportional Reporting Ratio(PRR)were used to mine the adverse event reports from2016 to 2019 in the Vaccine Adverse Event Reporting System(VAERS)of America,screened out the signals conforming of the threshold.The preferred systematic organ classification(SOC)and preferred terms(PT)of the Medical Dictionary for Drug Regulatory Affairs(MEDDRA)were used for statistics and classification.RESULTS 282 signals were obtained by RoR method and PRR method,and the number of related reports was 12491 cases,involving 24 SOCs.The top three SOC compositions corresponding to PT report number and signal number were:all kinds of injuries,poisoning and operating complications,all kinds of nervous system diseases,and all kinds of examinations.Pt that met the threshold were sorted in descending order according to signal number and signal intensity,and the top 50 Pts were screened out respectively.A total of 84 Pt signals were obtained,among which 34 signalled adverse reactions did not appear in the instructions of HPV9-valent vaccine.Mainly for reproductive system and mammary gland diseases,all kinds of nervous system diseases,mental diseases,eye organ diseases,a variety of musculoskeletal and connective tissue diseases.CONCLUSION The adverse reaction signals of HPV nine-valent vaccine are mainly concentrated in the nervous system.The new signals should be paid attention to clinically,and their correlation needs to be further studied.