| アブストラクト | BACKGROUND: Interstitial lung disease (ILD) was a relatively common cause of drug-induced mortality. However, the safety profile of the whole TKIs induced ILD was largely unknown. RESEARCH DESIGN AND METHODS: The reported cases of ILD associated with TKIs were downloaded from the FDA adverse event reporting system (FAERS) database between 1 January 2004 and 30 April 2022 to detect ILD signals by disproportionality analysis. Furthermore, the fatality rate and time to onset (TTO) of various TKIs were also calculated. RESULTS: The median age of total 2999 reported cases was 67. The largest reported cases came from osimertinib (n = 736, 24.5%). However, gefitinib had the highest ROR of 12.47 (11.4, 13.64) and IC of 3.53 (3.23, 3.86), means the strongest association with ILD. Trametinib, vemurafenib, larotectinib, selpercatinib, and cabozantinib did not show ILD signal. The median age of dead cases was 72 (Q1:62, Q3:83), and 53.02% (n = 579) were female and 41.11% (n = 449) were male. MET group showed the highest fatality rate of 55.17% with the shortest median TTO of 21 days (Q1: 8.5, Q3: 35.5). CONCLUSIONS: TKIs were significantly associated with ILD. More attention should be paid to female, older, MET group with shorter TTO, as their prognosis might be worse. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2023/4/8 |
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| 投稿者 | Zhang, Jing; Qiu, Ting; Zhou, Yiting; Wu, Shengjie; Chen, Enguo |
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| 組織名 | Department of Pharmacy, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang;University, Hangzhou, Zhejiang, China.;Department of Pulmonary and Critical Care Medicine, Regional medical center for;National Institute of Respiratory Diseases, Sir Run Run Shaw Hospital, School of;Medicine, Zhejiang University, Hangzhou, Zhejiang, China.;Institute of Translational Medicine, Medical College, Yangzhou University,;Yangzhou, Jiangsu, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37026465/ |
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