| アブストラクト | Immune checkpoint inhibitors (ICIs) are linked to severe biliary disorders (BDs). Using FAERS data (Q1 2015-Q1 2025), we identified 4,405 BD cases via standardized MedDRA queries (144 preferred terms). ICIs were significantly associated with BDs (overall ROR 3.37, 95% CI 3.28-3.47). Anti‑PD E/PD‑L1 monotherapy showed higher risk than anti‑CTLA E (ROR 3.19-4.19 vs 2.57), while combination therapy displayed extreme risks for bile duct necrosis (ROR 530.58) and immune‑mediated cholangitis (ROR 550.54). Fatal outcomes occurred in 19.9% (N=875) and were more common in males, patients aged >65 years, and those weighing <50 kg. Median time‑to‑onset was shortest for anti‑CTLA E (44.8 days, IQR 14-65); fatal cases had earlier onset than nonfatal ones (67.6 vs 114.3 days, P<0.0001). These findings highlight the strong association between ICI therapy and severe biliary injury, supporting the need for early biliary monitoring, particularly in high‑risk patients. |
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| ジャーナル名 | Journal of chemotherapy (Florence, Italy) |
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| Pubmed追加日 | 2026/1/13 |
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| 投稿者 | Wei, Shiju; Zhang, Zhenyu; Song, Xuhua; Chen, Rui; Chen, Siyu; Lu, Baoping |
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| 組織名 | The Second Clinical Medical College, Henan University of Chinese Medicine,;Zhengzhou, People's Republic of China.;The First Clinical Medical College, Henan University of Chinese Medicine,;Institute of Hepatology, Laboratory for the Prevention and Treatment of Digestive;System Diseases with Traditional Chinese Medicine, Henan University of Chinese;Medicine, Zhengzhou, People's Republic of China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41527380/ |
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