Drug-induced liver injury associated with pretomanid, bedaquiline, and linezolid: Insights from FAERS database analysis
文献类型：期刊论文
| 作者 | He, Qingfeng4; Li, Yang3; Liu, Sifan4; Xue, Hao2; Xiang, Xiaoqiang4; Wang, Tao1; Feng, Zhen1 |
| 刊名 | BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
 |
| 出版日期 | 2024-10-17 |
| 页码 | 9 |
| 关键词 | bedaquiline drug-induced liver injury (DILI) FAERS linezolid pretomanid tuberculosis |
| ISSN号 | 0306-5251 |
| DOI | 10.1111/bcp.16318 |
| 通讯作者 | Feng, Zhen(20211030065@fudan.edu.cn) |
| 英文摘要 | 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. |
| WOS关键词 | HEPATOTOXICITY |
| 资助项目 | National Natural Science Foundation of China |
| WOS研究方向 | Pharmacology & Pharmacy |
| 语种 | 英语 |
| WOS记录号 | WOS:001336606400001 |
| 出版者 | WILEY |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/313963]  |
| 专题 | 新药研究国家重点实验室 |
| 通讯作者 | Feng, Zhen |
| 作者单位 | 1.Xuzhou Med Univ, Affiliated Hosp, Dept Pharm, Xuzhou, Jiangsu, Peoples R China 2.Chinese Acad Sci, Shanghai Inst Mat Med, State Key Lab Drug Res, Shanghai, Peoples R China 3.Fudan Univ, Huashan Hosp, Shanghai Med Coll, Dept Infect Dis,Shanghai Key Lab Infect Dis & Bios, Shanghai, Peoples R China 4.Fudan Univ, Sch Pharm, Dept Clin Pharm & Pharm Adm, Shanghai, Peoples R China |
| 推荐引用方式 GB/T 7714 | He, Qingfeng,Li, Yang,Liu, Sifan,et al. Drug-induced liver injury associated with pretomanid, bedaquiline, and linezolid: Insights from FAERS database analysis[J]. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY,2024:9. |
| APA | He, Qingfeng.,Li, Yang.,Liu, Sifan.,Xue, Hao.,Xiang, Xiaoqiang.,...&Feng, Zhen.(2024).Drug-induced liver injury associated with pretomanid, bedaquiline, and linezolid: Insights from FAERS database analysis.BRITISH JOURNAL OF CLINICAL PHARMACOLOGY,9. |
| MLA | He, Qingfeng,et al."Drug-induced liver injury associated with pretomanid, bedaquiline, and linezolid: Insights from FAERS database analysis".BRITISH JOURNAL OF CLINICAL PHARMACOLOGY (2024):9. |
入库方式： OAI收割
来源：上海药物研究所
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