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

doi:10.13748/j.cnki.issn1007-7693.20232207

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

Mining and Analysis of Adverse Event Signals of Vericiguat Based on OpenFDA and Openvigil Databases

摘要

摘要:
目的评价维立西呱的用药安全性。
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。

Abstract:
OBJECTIVE To evaluate the drug safety of vericiguat.
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.
CONCLUSION 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.

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