| アブストラクト | OBJECTIVE: While current studies have focused on the incidence of moxifloxacin-associated liver injury, risk factors and clinical characteristics for moxifloxacin-induced liver injury in hospitalized patients remain unexplored. METHODS: We analysed antibiotic-induced liver injury using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. A retrospective observational study was further conducted on 1265 hospitalized patients treated with moxifloxacin for infections. Independent risk factors for moxifloxacin-induced DILI were identified via multivariable logistic regression. RESULTS: FAERS data indicated that moxifloxacin-induced liver injury exacerbates clinical outcomes, prolongs hospitalization, and may be life-threatening. Infections were the primary indication for fluoroquinolone use, with gender-specific differences observed in liver injury profiles across quinolones. Retrospective analyses revealed gender as an independent protective factor (p = 0.003). Risk factors included hypoalbuminemia (p = 0.003), hepatic comorbidities (fatty liver, p = 0.013; pre-existing liver injury, p < 0.013), elevated baseline alkaline phosphatase (ALP, p < 0.001) and concomitant use of traditional Chinese medicine or respiratory drugs (p < 0.001). CONCLUSION: Despite widespread clinical use, moxifloxacin's safety profile requires systematic evaluation. Clinicians should monitor liver function and integrate risk stratification, including albumin levels, gender and concomitant medications into prescribing practices. Elucidating DILI mechanisms and high-risk populations may optimize therapeutic decision-making and patient safety. |
| ジャーナル名 | Basic & clinical pharmacology & toxicology |
| Pubmed追加日 | 2025/12/31 |
| 投稿者 | Song, Yanqing; Li, Chunzi; Liu, Xiaoyue; Gao, Huan |
| 組織名 | Department of Pharmacy, Lequn Branch, the First Hospital of Jilin University,;Changchun, China.;Jilin Medical Association Secretariat, Changchun, China.;Department of Clinical Pharmacy, the First Hospital of Jilin University, |
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41474201/ |