| アブストラクト | BACKGROUND: Amphotericin B (AmB) remains the cornerstone in the treatment of severe fungal infections. However, selecting an appropriate lipid-based formulation for different clinical scenarios remains a challenge for clinicians and clinical pharmacists. METHODS: Adverse event (AE) reports from the FDA Adverse Event Reporting System (FAERS) database (Q1 2004-Q3 2024) were retrospectively analysed to assess the safety profiles of three lipid formulations of AmB: liposomal amphotericin B (L-AmB), amphotericin B lipid complex (ABLC), and amphotericin B colloidal dispersion (ABCD). The baseline patient characteristics, AE distributions, and prognostic outcomes of severe AEs were examined. SPSS software was used to compare AE occurrences among the three groups. RESULTS: A total of 3284 patient reports were included, comprising 3108 in the L-AmB group, 142 in the ABLC group, and 34 in the ABCD group. Within 30 days, AEs were reported in 666 cases (L-AmB), 72 cases (ABLC), and 13 cases (ABCD) (P < 0.001). AEs were categorised using the System Organ Class (SOC) and Standardized MedDRA Querie (SMQ). Compared with the L-AmB group, the ABLC group had a significantly higher incidence of hypersensitivity and hypertension; whereas hypokalemia was significantly lower (P < 0.001). Compared to the L-AmB and ABLC groups, the ABCD group had a significantly higher incidence of haematopoietic thrombocytopenia (P < 0.001). Prognostic analysis indicated that the incidence of life-threatening events was significantly higher in the ABCD group than in the L-AmB and ABLC groups (P < 0.001). CONCLUSION: The safety profiles of L-AmB, ABLC, and ABCD differ among organ systems. These findings highlight the need for individualised treatment strategies based on drug-specific safety characteristics and patient-specific clinical conditions to ensure optimal drug selection and patient safety. |
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| ジャーナル名 | Journal of pharmaceutical policy and practice |
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| Pubmed追加日 | 2025/6/16 |
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| 投稿者 | Tong, Binliang; Wang, Jiaqi; Zhang, Yanjing; Liu, Yan; Wang, Jing; Duan, Liguang; Yan, Yuhang; Sun, Qixuan; Luan, Yueyao; Yu, Jing; Zhou, Chunhua |
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| 組織名 | Pharmacy Department, The First Hospital of Hebei Medical University,;Shijiazhuang, Hebei, People's Republic of China.;Department of Clinical Pharmacy, The First Hospital of Hebei Medical University,;The Technology Innovation Center for Artificial Intelligence in Clinical Pharmacy;of Hebei Province, Shijiazhuang, Hebei, People's Republic of China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40519647/ |
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