基于FAERS数据库对环丙沙星致过敏的风险分析

Risk Analysis of Ciprofloxacin-Associated Allergy Based on the FAERS Database

摘要: 目的：基于FAERS数据库对环丙沙星(CFX)致过敏事件的信号挖掘研究，主要为探讨CFX诱导过敏反应的风险，为临床合理用药提供参考。方法：研究使用的信号生成方法为频数法，提取数据库中2018~2023年共24个季度的不良反应报告数据，运用报告比值比法(ROR)和综合标准法(MHRA)进行信号挖掘。得到有效信号后，再利用MedDRA术语集进行汉化及系统归类。结果：共检出81,725次以CFX为首的不良事件(ADE)报告，检测得到56,002个有效ADE信号，共累及23个不同系统器官(SOC)，主要集中在各种肌肉骨骼及结缔组织疾病、各类神经系统疾病、全身性疾病及给药部位各种反应等。对CFX致过敏不良事件按照MedDRA SMQ狭义水平(standardized MedDRA query, SMQ)进行分类汇总，获得过敏性/类过敏性休克病症(SMQ)、速发严重过敏反应(SMQ)相关的ADE报告总计1830例报告，共34个有效信号，其中急性肾损伤的上报例数最多(n = 382)，其次是荨麻疹(n = 325)。结论：对于药物过敏事件的发生人们往往关注的是常规的过敏体征，如皮疹，呼吸困难等，忽略了CFX引起急性肾损伤这一ADE的发生。因此，临床在使用CFX的过程中，除了监测患者是否有皮疹，水肿等情况发生，还应加强患者出入量的监测；合并过敏体质、肾脏系统等基础疾病的患者需加强评估，以确保临床合理用药。

Abstract: Objective: A signal mining study of ciprofloxacin (CFX)-induced anaphylactic events based on the FAERS database was conducted mainly to explore the risk of CFX-induced anaphylactic reactions and to provide a reference for the rational use of drugs in the clinic. Methods: The signal generation method used in the study was the frequency counting method, which extracted the adverse reaction report data from the database for a total of 24 quarters from 2018 to 2023, and applied the reporting ratio-ratio (ROR) and medicines and healthcare products regulatory agency (MHRA) methods for signal mining. After obtaining valid signals, the MedDRA terminology set was then used for handwriting and systematic categorisation. Results: A total of 81,725 CFX-led adverse events (ADE) were detected, and 56,002 valid ADE signals were obtained, involving 23 different system organs (SOCs), mainly focusing on a variety of musculoskeletal and connective tissue disorders, various neurological disorders, systemic disorders, and a variety of reactions at the site of drug administration. The CFX allergic adverse events were categorised and summarised according to standardised MedDRA query (SMQ), and a total of 1830 reports of anaphylactic/anaphylaxis-like conditions (SMQ), rapid-onset severe allergic reactions (SMQ)-associated ADE were obtained with a total of 34 valid signals, of which the highest number of reports (n = 1) was for acute kidney injury (AKI). highest number of reported cases (n = 382), followed by urticaria (n = 325). Conclusion: For the occurrence of drug allergic events people tend to focus on routine allergic signs, such as rash, dyspnoea, etc., ignoring the occurrence of acute kidney injury caused by CFX as an ADE. Therefore, in the process of using CFX in the clinic, in addition to monitoring whether the patients have skin rash, oedema, etc., should also strengthen the monitoring of the patient’s intake and output; combined with the allergic body, the renal system and other underlying diseases of the patients need to be strengthened to assess, in order to ensure the rational use of clinical medication.