| アブストラクト | BACKGROUND: Fluorouracil (5-FU) is widely used to treat metastatic colorectal cancer (mCRC), but real-world safety data is limited. Our study aimed to evaluate 5-FU's safety profile in a large mCRC population using the FAERS database. RESEARCH DESIGN AND METHODS: We conducted disproportionality analyses to identify adverse drug events associated with 5-FU use in mCRC patients from 2004 to 2023. Subgroup analyses, gender difference analyses, and logistic regression were also performed. RESULTS: We identified 1,458 reports with 5-FU as the primary suspected drug, with males accounting for 48.8% of reports. Gastrointestinal disorders were the most common adverse event (864 cases), while pregnancy-related conditions showed the strongest signal intensity (ROR = 2.97). We found 19 preferred terms with positive signals, including ischemic hepatitis (ROR = 59.32), blood iron increased (ROR = 59.32), and stress cardiomyopathy (ROR = 51.94). Males were more susceptible to weight loss and skin toxicity. Most adverse events occurred within the first month of 5-FU administration. CONCLUSION: Our study provides a comprehensive analysis of 5-FU's safety profile in mCRC patients, helping healthcare professionals mitigate risks in clinical practice. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2024/7/16 |
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| 投稿者 | Zhao, Ruiqi; Han, Mengyao; Lin, Sen; Lin, Zhimei; Yu, Mengjiao; Zhang, Bei; Ma, Lanyue; Li, Danfei; Peng, Lisheng |
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| 組織名 | The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine,;Shenzhen, Guangdong, China.;The Second Clinical Medical College of Guangzhou University of Chinese Medicine,;Guangzhou, Guangdong, China.;Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, Guangdong, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39010662/ |
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