目的 利用美国FDA不良事件报告系统（FAERS）对奥马环素进行药物不良反应（ADR）高危信号挖掘，为临床合理安全使用奥马环素提供参考。方法 下载2018年第4季度至2023年第2季度共19个季度的数据的FAERS数据，采用报告比值比法（ROR）和综合标准法（MHRA）对奥马环素的相关ADR报告数据进行信号挖掘。结果 共获取以奥马环素为首要怀疑药物的ADR报告1 180例，ROR法和MHRA法获得的奥马环素ADR风险信号基本一致，共获得奥马环素ADR信号35个，以植入物部位外渗和牙齿变色的ADR信号最强，且以胃肠道系统疾病（如恶心呕吐）最为多见，有12个ADR未在奥马环素药品说明书中出现。结论 利用FAERS数据库可对奥马环素的ADR信号进行挖掘与分析，可为临床合理安全用药提供依据。

Objective To provide guidance for the rational and safe use of omadacycline through mining and analyzing the adverse drug reaction (ADR) signals of omadacycline in FAERS. Methods A total of 19 quarters of FAERS data were downloaded from 2018 Q4 to 2023 Q2 and omadacycline related adverse events were extracted. The reporting odd ratio (ROR) and medicines and healthcare products regulatory agency (MHRA) method were used to detect the ADR signals. Results In the set period, FAERS received a total of 1 180 ADR reports with omadacycline as the primary suspected drug. The risk signals obtained by ROR method and MHRA method were basically the same, and a total of 35 omadacycline ADR signals were obtained. The ADR signals of implant site extravasation and tooth discolouration were the strongest, and the gastrointestinal system diseases (such as nausea and vomiting) were the most common. Totally 12 adverse event signals did not appear in the omadacycline drug instructions. Conclusion The data of FAERS can be used to analyze the ADR signals of omadacycline and provide evidence for clinical safety and rational drug use.

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广东省教育厅研究生教育创新计划项目（2023ANLK_046）；广州市科技计划项目（202103000002，201904010065）