维立西呱不良事件信号的挖掘与分析

Data mining and analysis for ADE signals of vericiguat

关键词:  维立西呱  维可同  不良反应  数据挖掘

Key words:  vericiguat  verquvo  \adverse reactions  data mining.

摘要:

目的:通过挖掘美国食品药品监督管理局不良事件呈报系统(FAERS)数据库中维立西呱的相关数据,探讨该药潜在不良反应,为临床安全用药提供依据。方法:采用报告比值比法(ROR)和贝叶斯可信区间递进神经网络(BCPNN),检测FAERS数据库中,维立西呱的不良事件信号,检索时限从2021年第1季度该药上市,至2023年第4季度共12个季度,并对结果进行分析。结果:得到与维立西呱相关的ADE阳性信号474例,其中包括说明书已记载的低血压、头晕、贫血等不良反应,还有说明书未记载的新的可疑药物警戒,包括晕厥、呼吸困难、胃肠出血、外周水肿、大脑梗塞、腹部不适。结论:通过挖掘FAERS数据可较全面深入地分析研究维立西呱上市后的不良反应,除说明书已记录不良反应外,还需要加强监测,关注新的不良反应,推动药品说明书的完善。

Abstract:

ABSTRACT：OBJECTIVE To explore the potential adverse reactions of vericiguat by mining the relevant data of FDA database of Adverse Event Reporting System(FAERS) to provide rationales for clinical safe drug dosing. METHODS Reporting odds ratio(ROR) and Bayesian confidence propagation neural network (BCPNN ) were utilized for simultaneously detecting the adverse event signals of vericiguat in the database of FAERS.The search time limit was from the first quarter of 2021 when the drug was launched to the fourth quarter of 2023.The results were analyzed for 12 quarters.RESULTS474 cases of ADE positive signals related to vericiguat were obtained, including adverse reactions such as hypotension, dizziness, and anemia as recorded in the instructions, as well as new suspicious drug warnings not recorded in the instructions, including syncope, breathing difficulties, gastrointestinal bleeding, peripheral edema, cerebral infarction, and abdominal discomfort. Conclusion: By mining FAERS data, the adverse reactions of vericiguat after marketing can be comprehensively and deeply analyzed. In addition to the adverse reactions recorded in the instructions, it is also necessary to strengthen monitoring, pay attention to new adverse reactions, and promote the improvement of the drug instructions.