基于OpenFDA和Openvigil数据库对维立西呱不良事件信号挖掘与分析

孙佳斌; 石佳娜; 胡颖; 钱正仙; 赵鹏程; 高曼琦; 嵇艳兰

引用本文:	孙佳斌,石佳娜,胡颖,钱正仙,赵鹏程,高曼琦,嵇艳兰.基于OpenFDA和Openvigil数据库对维立西呱不良事件信号挖掘与分析[J].中国现代应用药学,2025,42(7):120-124.
	Sun Jiabin,SHI Jiana,HU Ying,QIAN Zhengxian,ZHAO Pengcheng,GAO Manqi,JI Yanlan.Mining and Analysis of Adverse Event Signals of Vericiguat Based onOpenFDA and Openvigil Databases[J].Chin J Mod Appl Pharm(中国现代应用药学),2025,42(7):120-124.

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基于OpenFDA和Openvigil数据库对维立西呱不良事件信号挖掘与分析
孙佳斌,石佳娜,胡颖,钱正仙,赵鹏程,高曼琦,嵇艳兰
1.德清县人民医院;2.浙江省人民医院;3.浙江工业大学

摘要:

目的评价维立西呱的用药安全性，为临床合理用药提供参考。方法检索OpenFDA数据库，获取维立西呱相关的不良事件（Adverse Events, AE）报告，筛选发生例数前10位药物不良反应（Adverse Drug Reaction, ADR）；检索Openvigil数据库，根据比值失衡法中的报告比值比（Reporting Odds Ratio, ROR）大小进行筛选，选出前10位ADR。结果 OpenFDA数据库共检索到维立西呱AE报告500例，前3位ADR是低血压、死亡、心力衰竭。Openvigil数据库共检索到维立西呱不良事件296种，根据ROR排序前3位不良反应是心肾综合征、射血分数异常、慢性心力衰竭。结论临床在使用维立西呱时需要严密监护血压和血常规，药师需要加强ADR的监护，并做好不良反应防治的相关宣教。

关键词: 维立西呱 OpenFDA Openvigil 不良反应

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基金项目:浙江省教育厅一般研究项目；教育部产学合作协同育人项目；德清县哲学社会科学规划项目

Mining and Analysis of Adverse Event Signals of Vericiguat Based onOpenFDA and Openvigil Databases

Sun Jiabin^1,2,3, SHI Jiana^4,2,3, HU Ying^4,2,3, QIAN Zhengxian^4,2,3, ZHAO Pengcheng⁵, GAO Manqi^1,2,3, JI Yanlan^1,2,3

1.Deqing People'2.'3.s Hospital;4.Zhejiang Provincial People'5.Zhejiang University of Technology

Abstract:

Objective To evaluate the drug safety of vericiguat and provide reference for rational drug use in clinic. Methods The OpenFDA database was searched for reports of adverse events (AE) related to vericiguat, and the top 10 adverse drug reactions (ADR) reports were selected. The Openvigil database was searched, and the top 10 ADRs were selected according to the Reporting Odds Ratio (ROR) in the ratio imbalance method. Results A total of 500 AEs about vericiguat were found in the OpenFDA database, and the top 3 ADRs were hypotension, death, and cardiac failure. A total of 296 AEs of vericiguat were found in the Openvigil database. The top 3 adverse reactions ranked by ROR were cardiorenal syndrome, ejection fraction abnormal, and cardiac failure chronic. Conclusions It is necessary to closely monitor blood pressure and blood routine when using vericiguat in clinic. Pharmacists need to strengthen the monitoring of ADR, and do a good job in the prevention and treatment of adverse reactions.

Key words: vericiguat OpenFDA Openvigil adverse reaction