{"title":"评价紫杉烷类药物治疗缺血性结肠炎的安全风险：基于FDA不良事件报告系统的歧化分析。","authors":"Yufang Liao, Yanbin Zeng, Xiaorong Su, Wanlong Lin, Xiuxian Lin, Lizhu Weng, Jianhui Yang, Wei Zhuang, Junyan Wu","doi":"10.1080/14740338.2025.2529429","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Ischaemic colitis (IC) is a rare yet serious gastrointestinal condition, increasingly reported in patients receiving taxanes-based chemotherapy. So far, the correlation between the two remains unclear. The aim of this study is to assess the safety concerns associated with taxanes use in relation to IC.</p><p><strong>Research design and methods: </strong>Disproportionality analyses (Reporting Odds Ratio [ROR], Proportional Reporting Ratio [PRR], Bayesian Confidence Propagation Neural Network [BCPNN], Multi-item gamma Poisson Shrinker [MGPS]) were conducted using the FDA Adverse Event Reporting System (FAERS, 2005 Q1-2023 Q2).</p><p><strong>Results: </strong>Significant IC signals were detected across taxanes: paclitaxel (ROR 4.07, PRR 4.07, BCPNN 2.02, MGPS 4.05), nab-paclitaxel (ROR 2.99, PRR 2.99, BCPNN 1.58, MGPS 2.98,), and docetaxel (ROR 3.63, PRR 3.63, BCPNN 1.85, MGPS 3.59). Reports were predominantly from Japan and the U.S.A. with IC developing within 16 days in half of the patients.</p><p><strong>Conclusion: </strong>Taxanes may substantially increase IC risk, necessitating vigilant gastrointestinal monitoring and characterization of high-risk populations. Further clinical validation is required to confirm these findings.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.1000,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Evaluating safety risks of ischaemic colitis with taxanes: a disproportionality analysis based on FDA adverse event Reporting system.\",\"authors\":\"Yufang Liao, Yanbin Zeng, Xiaorong Su, Wanlong Lin, Xiuxian Lin, Lizhu Weng, Jianhui Yang, Wei Zhuang, Junyan Wu\",\"doi\":\"10.1080/14740338.2025.2529429\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Ischaemic colitis (IC) is a rare yet serious gastrointestinal condition, increasingly reported in patients receiving taxanes-based chemotherapy. So far, the correlation between the two remains unclear. The aim of this study is to assess the safety concerns associated with taxanes use in relation to IC.</p><p><strong>Research design and methods: </strong>Disproportionality analyses (Reporting Odds Ratio [ROR], Proportional Reporting Ratio [PRR], Bayesian Confidence Propagation Neural Network [BCPNN], Multi-item gamma Poisson Shrinker [MGPS]) were conducted using the FDA Adverse Event Reporting System (FAERS, 2005 Q1-2023 Q2).</p><p><strong>Results: </strong>Significant IC signals were detected across taxanes: paclitaxel (ROR 4.07, PRR 4.07, BCPNN 2.02, MGPS 4.05), nab-paclitaxel (ROR 2.99, PRR 2.99, BCPNN 1.58, MGPS 2.98,), and docetaxel (ROR 3.63, PRR 3.63, BCPNN 1.85, MGPS 3.59). Reports were predominantly from Japan and the U.S.A. with IC developing within 16 days in half of the patients.</p><p><strong>Conclusion: </strong>Taxanes may substantially increase IC risk, necessitating vigilant gastrointestinal monitoring and characterization of high-risk populations. Further clinical validation is required to confirm these findings.</p>\",\"PeriodicalId\":12232,\"journal\":{\"name\":\"Expert Opinion on Drug Safety\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.1000,\"publicationDate\":\"2025-07-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Expert Opinion on Drug Safety\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/14740338.2025.2529429\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Opinion on Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14740338.2025.2529429","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Evaluating safety risks of ischaemic colitis with taxanes: a disproportionality analysis based on FDA adverse event Reporting system.
Background: Ischaemic colitis (IC) is a rare yet serious gastrointestinal condition, increasingly reported in patients receiving taxanes-based chemotherapy. So far, the correlation between the two remains unclear. The aim of this study is to assess the safety concerns associated with taxanes use in relation to IC.
Research design and methods: Disproportionality analyses (Reporting Odds Ratio [ROR], Proportional Reporting Ratio [PRR], Bayesian Confidence Propagation Neural Network [BCPNN], Multi-item gamma Poisson Shrinker [MGPS]) were conducted using the FDA Adverse Event Reporting System (FAERS, 2005 Q1-2023 Q2).
Results: Significant IC signals were detected across taxanes: paclitaxel (ROR 4.07, PRR 4.07, BCPNN 2.02, MGPS 4.05), nab-paclitaxel (ROR 2.99, PRR 2.99, BCPNN 1.58, MGPS 2.98,), and docetaxel (ROR 3.63, PRR 3.63, BCPNN 1.85, MGPS 3.59). Reports were predominantly from Japan and the U.S.A. with IC developing within 16 days in half of the patients.
Conclusion: Taxanes may substantially increase IC risk, necessitating vigilant gastrointestinal monitoring and characterization of high-risk populations. Further clinical validation is required to confirm these findings.
期刊介绍：
Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports.
Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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