中国药物警戒 ›› 2025, Vol. 22 ›› Issue (8): 933-936.
DOI: 10.19803/j.1672-8629.20240596

• 安全与合理用药 • 上一篇    下一篇

基于美国FAERS数据库的奥马环素和莫西沙星不良事件分析

刘疆1, 陈洁1, 邱思鸿1, 李娜1, 周莹2, 陈永刚1, 罗季1*   

  1. 1云南省传染病临床医学中心,昆明市第三人民医院药学部,云南 昆明 650000;
    2大理大学药学院,云南 大理 671000
  • 收稿日期:2024-08-23 出版日期:2025-08-15 发布日期:2025-08-13
  • 通讯作者: *罗季,女,本科,副主任药师,抗感染临床研究。E-mail：59892652@qq.com
  • 作者简介:刘疆,女,在读硕士,临床药学。
  • 基金资助:
    云南省孔令义专家工作站（2019IC047）; 昆明理工大学“双一流”科技专项（202302AG050003）

Analysis of Adverse Drug Event Induced by Omacycline and Moxifloxacin Based on FAERS Databse

LIU Jiang1, CHEN Jie1, QIU Sihong1, LI Na1, ZHOU Ying2, CHEN Yonggang1, LUO Ji1*   

  1. 1Yunnan Clinical Center for Infectious Diseases, The Third People's Hospital of Kunming, Kunming Yunnan 650000, China;
    2College of Pharmacy, Dali University, Dali Yunnan 671000, China
  • Received:2024-08-23 Online:2025-08-15 Published:2025-08-13

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摘要： 目的 为临床上安全使用奥马环素和莫西沙星治疗社区获得性肺炎提供参考。方法 利用美国食品药品监督管理局（Food and Drug Administration, FDA）不良事件报告系统（Adverse Event Reporting System, FAERS）数据库收集奥马环素与莫西沙星从2004 年第1季度至2024 年第1季度的药品不良事件（ADE）报告,采用计算报告比值比（ROR）法以及英国药品和健康产品管理局（Medicines and Healthcare Products Regulatory Agency,MHRA）的综合标准法来挖掘两药的ADE信号并进行分析。结果 共收集到奥马环素和莫西沙星的ADE报告分别为527、16 614 份,性别构成比均为男性多于女性。经信号筛选,得到奥马环素45个ADE信号、莫西沙星607个ADE信号。药物发生频次最多的3 个ADE信号奥马环素为恶心、呕吐、腹泻（分别为108、61、37 例）,在其药品说明书中均有记载,而莫西沙星分别为皮疹、头晕、超敏反应（分别为1 198、1 157、945 例）,其中头晕未在说明书中记载。按信号强度排序,奥马环素的输液部位静脉炎（ROR值为635.83）和莫西沙星的虹膜缺失检测阳性（ROR值为3 478.69）位列第一,奥马环素被其药品说明书记载,而莫西沙星说明书中未被记载。结论 奥马环素ADE主要累及到各类损伤、中毒及操作并发症和胃肠系统疾病;而莫西沙星主要累及神经系统疾病和全身性疾病及给药部位各种反应,且新的可疑风险信号较多。

关键词: 奥马环素, 莫西沙星, 药品不良事件, 信号挖掘, 报告比值比法, 综合标准法

Abstract: Objective To provide a reference for clinically safe use of omacycline and moxifloxacin in the treatment of community-acquired pneumonia. Methods Adverse Drug Event (ADE) reports concerning omadacycline and moxifloxacin and collected between the first quarter of 2004 and the first quarter of 2024 were retrieved from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. The Reporting Odds Ratio (ROR) method and the comprehensive criteria of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK were employed to mine and analyze ADE signals for both drugs. Results A total of 527 ADE reports about omadacycline and 16 614 ones about moxifloxacin were collected. Males outnumbered females in both groups. After signal screening, 45 ADE signals were identified for omadacycline and 607 for moxifloxacin. The three most frequent ADE signals for omadacycline were nausea (108 cases), vomiting (61 cases), and diarrhea (37 cases), all of which were specified in package inserts. For moxifloxacin, the three most frequent ADE signals were rash (1 198 cases), dizziness (1 157 cases), and hypersensitivity reactions (945 cases), among which dizziness was not documented in its package insert. When ranked by signal strength, infusion site phlebitis for omadacycline (with an ROR value of 635.83) and irideremia that tested positive for moxifloxacin (with an ROR value of 3 478.69) topped the list. The ADE signal was specified in the package insert of omadacycline, but not for moxifloxacin. Conclusion The ADEs of omadacycline usually involve various injuries, poisoning, procedural complications, and gastrointestinal system diseases while those of moxifloxacin are primarily related to neurological diseases, systemic diseases, and various reactions at the site of administration, with a relatively high number of signals of new suspicious high risks.

Key words: Omacycline, Moxifloxacin, Adverse Drug Events, Signal Mining, Reporting Odds Ratio Method(ROR), Comprehensive Criteria

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