左氧氟沙星相关肌腱疾病：使用FAERS和JADER进行的性别、年龄和给药途径特异性不成比例分析
Levofloxacin-associated tendon disorders: Sex-, age-, and route-specific disproportionality analysis using FAERS and JADER.
摘要(中文译文)
本研究利用两个自发报告系统——美国食品药品监督管理局不良事件报告系统（FAERS）和日本不良药物事件报告数据库（JADER），评估了日本人群中单个氟喹诺酮类药物与肌腱疾病之间的关联。研究分析了五种药物——环丙沙星、左氧氟沙星、莫西沙星、诺氟沙星和氧氟沙星——与“肌肉、肌腱和韧带损伤”及“肌腱疾病”的关系。在FAERS中，所有氟喹诺酮类药物均显示阳性信号，而在FAERS日本子集和JADER中，仅左氧氟沙星表现出一致且稳健的关联。在JADER中，左氧氟沙星对肌肉、肌腱和韧带损伤（报告比值比[ROR] 30.6，信息成分[IC] 4.5）及肌腱疾病（ROR 134.2，IC 5.8）均显示出强信号。分层分析显示，男性中信号明显更强，尤其是年龄≥70岁者（相对ROR分别为12.21和25.67；IC差值分别为3.18和2.85）。口服左氧氟沙星的报告比值比高于静脉给药。发病时间分析表明，大多数肌腱相关不良事件发生在用药开始后14天内。左氧氟沙星与肌腱疾病的关联最为一致且稳健，尤其是在日本年龄≥70岁的男性中。因此，日本临床医生在给老年男性患者处方左氧氟沙星时应谨慎。
Abstract
This study evaluated the association between individual fluoroquinolones and tendon disorders in Japan using two spontaneous reporting systems: the Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER). Five agents-ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin-were analyzed for "Muscle, tendon and ligament injuries" and "Tendon disorders." All fluoroquinolones showed positive signals in the FAERS, whereas only levofloxacin demonstrated consistent and robust associations in the Japanese subset of the FAERS and the JADER. In the JADER, levofloxacin exhibited strong signals for muscle, tendon, and ligament injuries (reporting odds ratio [ROR] 30.6, information component [IC] 4.5) and tendon disorders (ROR 134.2, IC 5.8). Stratified analysis revealed markedly stronger signals in males, particularly those aged ≥70 years (relative ROR 12.21 and 25.67; IC delta 3.18 and 2.85, respectively). Oral levofloxacin was associated with higher reporting odds than intravenous administration. Time-to-onset analysis indicated that most tendon-related adverse events occurred within 14 days after drug initiation. Levofloxacin exhibited the most consistent and robust association with tendon disorders, especially in males aged ≥70 years in Japan. Therefore, clinicians in Japan should exercise caution when prescribing levofloxacin to older male patients.
如何引用
AMA
Toshihisa Nakashima, Yoshihiro Noguchi, Rikuto Masuda, Tomoaki Yoshimura. Levofloxacin-associated tendon disorders: Sex-, age-, and route-specific disproportionality analysis using FAERS and JADER.. PloS one. 2026; doi:10.1371/journal.pone.0358427.
APA
Toshihisa Nakashima, Yoshihiro Noguchi, Rikuto Masuda, Tomoaki Yoshimura (2026). Levofloxacin-associated tendon disorders: Sex-, age-, and route-specific disproportionality analysis using FAERS and JADER.. PloS one. https://doi.org/10.1371/journal.pone.0358427
GB/T 7714
Toshihisa Nakashima, Yoshihiro Noguchi, Rikuto Masuda, Tomoaki Yoshimura. Levofloxacin-associated tendon disorders: Sex-, age-, and route-specific disproportionality analysis using FAERS and JADER.[J]. PloS one, 2026 doi:10.1371/journal.pone.0358427.
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