| アブストラクト | AIMS: The emergence of drug-resistant tuberculosis has necessitated novel treatments like the pretomanid, bedaquiline and linezolid (BPaL) regimen. This study investigated the association of drug-induced liver injury (DILI) with the BPaL regimen compared to first-line antituberculosis drugs (isoniazid, rifampin, pyrazinamide and ethambutol [HRZE]). METHODS: A retrospective pharmacovigilance analysis was conducted using data from the US Food and Drug Administration Adverse Event Reporting System database from July 2019 to June 2023. Disproportionality analysis was employed to calculate the reporting odds ratio (ROR) of DILI for each component of the BPaL regimen. Onset time and mortality rates of DILI across different regimens were also compared. RESULTS: We identified 1242 cases of BPaL-related DILI. Most cases occurred in individuals under 65 years of age (63.8%), with more male patients affected than females (51.4% vs 39.5%). The association between antituberculosis drugs and DILI was stronger for the HRZE regimen (ROR = 7.99, 95% confidence interval [CI] 7.74-8.25) than the BPaL regimen (ROR = 4.75, 95% CI 4.55-4.97). The median onset time for DILI was significantly shorter with the BPaL regimen (8 days, interquartile range [IQR] 3-28) compared to the HRZE regimen (20 days, IQR 6-48) (P < .001). Additionally, the BPaL regimen was associated with a higher risk of death due to DILI compared to the HRZE regimen (14.1% vs 10.4%, P = .003). CONCLUSIONS: Although the BPaL regimen had a lower overall risk of DILI compared to the HRZE regimen, it was significantly associated with DILI, indicating a need for careful monitoring during treatment. |
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| ジャーナル名 | British journal of clinical pharmacology |
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| 投稿日 | 2024/10/18 |
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| 投稿者 | He, Qingfeng; Li, Yang; Liu, Sifan; Xue, Hao; Xiang, Xiaoqiang; Wang, Tao; Feng, Zhen |
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| 組織名 | Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy,;Fudan University, Shanghai, China.;Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases;and Biosafety Emergency Response, National Medical Center for Infectious;Diseases, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai,;China.;State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica,;Chinese Academy of Sciences, Shanghai, China.;Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University,;Xuzhou, Jiangsu, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39419512/ |
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