莫西沙星致精神病类疾病的风险分析

Risk Analysis of Psychiatric Disorders Induced by Moxifloxacin

摘要: 目的：基于FAERS对莫西沙星进行不良事件的信号挖掘研究，主要为探讨莫西沙星诱导精神病类疾病的风险，从而为其所致精神病类疾病的预防和治疗提供依据。方法研究使用的信号生成方法为频数法，提取数据库2018年第一季度至2023年第三季度共23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法)进行信号挖掘，要求每一个信号均符合两种方法的筛选条件。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15,859次以莫西沙星为首的不良事件(ADE)报告，检测得到590个有效ADE信号，共累及22个不同系统器官(SOC)，主要集中在各类神经系统疾病、精神病类疾病、眼器官疾病等。对莫西沙星致精神类疾病不良事件按照MedDRA高位组语(HLGT)进行分类汇总，获得精神病类系统相关的ADE报告总计1095例报告，共42个有效信号。结论：临床应用莫西沙星时需监测患者精神状态变化情况，如果有焦虑、谵妄、意识状态模糊时，及时进行情感疏导；有抑郁症、精神分裂症、焦虑症相关基础疾病的患者需加强评估，以保证临床合理用药。

Abstract: Objective: Signal mining study of adverse events (ADEs) based on FAERS on moxifloxacin, mainly to explore the risk of psychiatric disorders, and thus provide a basis for the prevention and treatment of psychiatric disorders caused by moxifloxacin. Methods: The reports of the above-mentioned drugs in the 23 quarters from the first quarter of 2018 to the third quarter of 2023 were extracted from the FAERS database, and the reported ratio method (ROR method) and the comprehensive standard method (MHRA method) were used to jointly test, and then use the MedDRA terminology set Chinese and System organ classification standardized the results. Results: Totally 15,859 ADE with moxifloxacin as the primary suspected drug were retrieved as the original data. A total of 590 ADE signals were obtained from the moxifloxacin. The signals involved 22 different system organs (SOC). The ADEs of moxifloxacin was mainly involved in “various neurological diseases”, “psychiatric disorders” and “diseases of the eye organs”. Moxifloxacin-induced psychiatric adverse events were categorised and summarised according to MedDRA high level group terms (HLGT), obtaining a total of 1095 reports of ADEs related to psychiatric systems, with a total of 42 valid signals. Conclusion: Clinical application of moxifloxacin needs to monitor the patient’s mental status changes, if there is anxiety, delirium, blurred state of consciousness, and timely emotional counselling; patients with depression, schizophrenia-related underlying diseases need to strengthen the assessment, in order to ensure that the clinical rationality of the use of drugs.