| アブストラクト | BACKGROUND : There have been cases reporting anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) and associated serious gastrointestinal (GI) adverse drug reactions (gastrointestinal obstruction, perforation, and ulceration). These adverse drug reactions are not in the drug package inserts, and the drug relationships are not proven in the literature. AIM: We aimed to examine the potential association between GI obstruction, perforation, and ulceration, and ALK-TKIs by data mining of the US FDA Adverse Event Reporting System (FAERS). METHOD : We conducted a disproportionality analysis of GI obstruction, perforation, and ulceration by estimating the reporting odds ratios (ROR) and the information component (IC) with 95% confidence intervals. RESULTS : A total of 279 cases of ALK-TKI-associated GI obstruction, perforation, and ulceration from January 1, 2011, to December 31, 2020, were identified. GI obstruction, perforation, and ulceration cause 16% of cases of death. A significantly increased reporting rate for GI obstruction [ROR 1.77 (1.45-2.15); IC 0.82 (0.53-2.03)] and perforation [ROR 1.61 (1.28-2.02); IC 0.68 (0.35-1.92)] was observed for ALK-TKIs as a drug class. The signal of GI ulceration was detected only in crizotinib [ROR 1.23 (1.01-1.50); IC 0.29 (0.01-1.51)]. A statistically significant ROR and IC emerged for the site of the esophagus. CONCLUSION : Overall, the pharmacovigilance study of the FAERS indicates slightly increased reporting of GI obstruction and perforation, which may cause severe or even fatal outcomes among ALK-TKIs users. |
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| ジャーナル名 | International journal of clinical pharmacy |
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| 投稿日 | 2022/7/2 |
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| 投稿者 | Huang, Jing; Zhao, Yibei; Cao, Yanni; Zhang, Qingxia; Ran, Dongzhi; Li, Jinyan; Luo, Ling; Qiu, Feng; Meng, Long |
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| 組織名 | Department of Respiratory and Critical Care Medicine, The First Affiliated;Hospital of Chongqing Medical University, 400016, Chongqing, China.;Department of Pharmacology, The Key Laboratory of Biochemistry and Molecular;Pharmacology, Chongqing Medical University, 400016, Chongqing, China.;Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical;University, No. 1 Youyi Road, Yuanjiagang, Yuzhong District, 400016, Chongqing,;China.;Department of Pharmacy, National Clinical Research Center for Geriatric Disease,;Xuanwu Hospital Capital Medical University, 100053, Beijing, China.;Information Center, The First Affiliated Hospital of Chongqing Medical;University, 400016, Chongqing, China.;Department of Pharmacy, Nanshan Community Health Service Center, 400060,;Chongqing, China.;China. cpu0641022@sina.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/35776375/ |
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