基于FAERS和JADER的伏诺拉生不良事件数据挖掘与分析

Signal mining and analysis of adverse drug events of vonoprazan based upon FAERS and JADER database

目的:伏诺拉生是一种新型钾离子竞争性酸阻滞剂,由于其新颖性,其长期安全性和不良事件仍有待进一步研究和证实。方法:通过美国食品药品监督管理局不良事件报告系统(FAERS)和日本药品不良事件报告系统(JADER)系统搜索并提取2015—2023年的相关不良事件报告,并利用《定期活动的医学词典》术语集进行不良事件系统归类,再通过报告比值比法(reporting odds ratio,ROR)和比例报告比(proportional reporting ratio,PRR)对药物相关报告进行数据处理及分析。结果:在首选术语分析中,FAERS数据库中重要信号顺序排列为:促黄体生成素缺乏症(ROR=2 066.06,PRR=2 065.82)、胆囊扭转(ROR=2 065.94,PRR=2 065.82)、食管吻合术(ROR=1 377.37,PRR=1 377.21)等;JADER数据库中重要信号排列顺序为:血胃泌激素升高(ROR=1 535.76,PRR=1 525.05)、胃泌素瘤(ROR=930.27,PRR=928.29)、十二指肠息肉(ROR=398.20,PRR=397.84)等。在系统器官分类分析中,FAERS数据库中重要信号分别按以下顺序排列:内分泌系统疾病(ROR=5.36,PRR=5.31)、肝胆系统疾病(ROR=5.14,PRR=4.98)、血液和淋巴系统疾病(ROR=2.96,PRR=2.87)等;JADER数据库中重要信号排列顺序为:社会环境(ROR=4.54,PRR=4.53)、妊娠期、产褥期及围产期状况(ROR=3.81,PRR=3.81)、皮肤及皮下组织类疾病(ROR=3.16,PRR=3.15)等。结论:基于FAERS和JADER数据库的信号挖掘结果提示应重视伏诺拉生药物相关不良事件风险,加强临床用药监护,降低AEs对患者预后和生活质量的影响。

OBJECTIVE Vonoprazan is a novel potassium competitive acid blocker.Due to its novelty,its long-term safety and adverse events still need to be further confirmed.METHODS From 2015 to 2023,the relevant adverse event reports were searched and extracted through the FDA Adverse Event Reporting System(FAERS) and the Japanese Adverse Drug Event Reporting System(JADER) and the adverse event system was classified using the Medical Dictionary for Regularly Activities terminology set.Data processing and analysis of drug-related reports were performed by reporting odds ratio(ROR) and proportional reporting ratio(PRR).RESULTS In the analysis of preferred terms,the important signals in the FAERS database were deficiency of luteinizing hormone(ROR=2 066.06,PRR=2 065.82),gallbladder torsion(ROR=2 065.94,PRR=2 065.82) and esophageal anastomosis(ROR=1 377.37,PRR=1 377.21).The important signal orders of JADER database were as follows:elevated blood gastrin(ROR=1 535.76,PRR=1 525.05),gastrinoma(ROR=930.27,PRR=928.29) and duodenal polyps(ROR=398.20,PRR=397.84).In the analysis of system organ classification,the important signals of FAERS database were arranged in the following order:endocrine disorders(ROR=5.36,PRR=5.31),hepatobiliary disorders(ROR=5.14,PRR=4.98) and blood/lymphatic system disorders(ROR=2.96,PRR 2.87).The important signals of JADER database were ranked as follows:social circumstances(ROR=4.54,PRR=4.53),pregnancy,puerperium & perinatal conditions(ROR=3.81,PRR=3.81) and skin/subcutaneous tissue disorders(ROR=3.16,PRR=3.15).CONCLUSION The signal mining results based upon FAERS and JADER databases suggest that pharmacists should pay greater attention to the risk of venolazone related adverse events.And clinical medication monitoring should be strengthened for minimizing the impact of adverse reactions on patient prognosis and quality-of-life.