{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T20:36:58Z","timestamp":1792010218576,"version":"4.4.0"},"reference-count":26,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2024,10,17]],"date-time":"2024-10-17T00:00:00Z","timestamp":1729123200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82204502"],"award-info":[{"award-number":["82204502"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>The emergence of drug\u2010resistant tuberculosis has necessitated novel treatments like the pretomanid, bedaquiline and linezolid (BPaL) regimen. This study investigated the association of drug\u2010induced liver injury (DILI) with the BPaL regimen compared to first\u2010line antituberculosis drugs (isoniazid, rifampin, pyrazinamide and ethambutol [HRZE]).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      We identified 1242 cases of BPaL\u2010related DILI. Most cases occurred in individuals under 65\u2009years of age (63.8%), with more male patients affected than females (51.4%\n                      <jats:italic>vs<\/jats:italic>\n                      39.5%). The association between antituberculosis drugs and DILI was stronger for the HRZE regimen (ROR\u2009=\u20097.99, 95% confidence interval [CI] 7.74\u20108.25) than the BPaL regimen (ROR\u2009=\u20094.75, 95% CI 4.55\u20104.97). The median onset time for DILI was significantly shorter with the BPaL regimen (8\u00a0days, interquartile range [IQR] 3\u201028) compared to the HRZE regimen (20\u2009days, IQR 6\u201048) (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u2009.001). Additionally, the BPaL regimen was associated with a higher risk of death due to DILI compared to the HRZE regimen (14.1%\n                      <jats:italic>vs<\/jats:italic>\n                      10.4%,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u2009.003).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bcp.16318","type":"journal-article","created":{"date-parts":[[2024,10,17]],"date-time":"2024-10-17T20:18:21Z","timestamp":1729196301000},"page":"799-807","source":"Crossref","is-referenced-by-count":8,"title":["Drug\u2010induced liver injury associated with pretomanid, bedaquiline, and linezolid: Insights from FAERS database analysis"],"prefix":"10.1111","volume":"91","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5795-1550","authenticated-orcid":false,"given":"Qingfeng","family":"He","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yang","family":"Li","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sifan","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hao","family":"Xue","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica Chinese Academy of Sciences  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoqiang","family":"Xiang","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tao","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy the Affiliated Hospital of Xuzhou Medical University  Xuzhou Jiangsu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4090-5966","authenticated-orcid":false,"given":"Zhen","family":"Feng","sequence":"additional","affiliation":[{"name":"Department of Pharmacy the Affiliated Hospital of Xuzhou Medical University  Xuzhou Jiangsu China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,10,17]]},"reference":[{"key":"e_1_2_10_2_1","volume-title":"Global tuberculosis report","author":"World Health Organization","year":"2023"},{"key":"e_1_2_10_3_1","volume-title":"Center for Drug Evaluation and Research: application number 212862Orig1s000","author":"US Food and Drug Administration","year":"2019"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1901814"},{"key":"e_1_2_10_5_1","volume-title":"Provisional CDC guidance for the use of pretomanid as part of a regimen [bedaquiline, pretomanid, and linezolid (BPaL)] to treat drug\u2010resistant tuberculosis disease","author":"Centers for Disease Control and 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