关键词: 塞来昔布, FAERS, 不良事件：信号挖掘, 报告比值比法, 综合标准法, 信息成分法

Abstract: Objective To mine the signals of adverse drug events (ADE) related to celecoxib based on the US FDA Adverse Event Reporting System (FAERS) database, and to provide reference for safe use of drugs in clinic. Methods The reporting odds ratio method, MHRA and the information component method were used to mine ADE signals of celecoxib from the FAERS database between the first quarter of 2004 and the fourth quarter of 2022. Results A total of 37 020 cases of celecoxib-related ADE were retrieved, involving 4 068 types of ADE. After screening, 285 signals were obtained, which involved 23 different system organ classes (SOC). According to signal intensity, the top 5 signals were related to oesophageal fibrosis, primary headache associated with sexual activity, cerebrovascular disorders, gastrointestinal adenocarcinoma and cardiovascular disorders. The ADE signals not stated in instructions on celecoxib included retinal vein thrombosis, blindness, amnesia and anaphylactic shock. Conclusion Those who Adverse event reported ADE were mostly over 45 years old and female. Most of the reports came from the United States. signals were basically consistent with the instructions. The ADE of celecoxib mainly involved cardiac disorders, nervous system disorders, immune system disorders, and gastrointestinal disorders. ADE signals related to myocardial infarction, cardiovascular disorders, gastric ulcer, gastric haemorrhage and gastric ulcer perforation as described in black box warnings in the instructions were all detected. When celecoxib is used, clinicians should be alert to cardiovascular and cerebrovascular symptoms, gastrointestinal disorders and retinal diseases of patients while ensuring effective monitoring.

Key words: celecoxib, FAERS, adverse event, signal mining, reporting odds ratio method, MHRA, information component method