据报道，卡培他滨与严重的胃肠道 (GI) 药物不良反应（胃肠道溃疡、出血和梗阻）有关。然而，统计相关性尚未得到证实，并且特定的胃肠道药物不良反应，例如胃肠道梗阻，也没有在其标签上列出。我们旨在通过以下方法确定卡培他滨与乳腺癌患者胃肠道溃疡、出血或梗阻之间的关联：检查来自美国食品和药物管理局不良事件报告系统 (FAERS) 的数据。我们通过评估报告比值比 (ROR) 和信息成分 (IC) 的 95%，对胃肠道溃疡、出血和梗阻进行不成比例分析。我们确定了 2004 年 1 月 1 日至 2020 年 12 月 31 日期间报告的 279 名与卡培他滨相关的胃肠道溃疡、出血或梗阻患者。其中四分之一的胃肠道溃疡、出血或梗阻病例导致死亡。卡培他滨作为一种药物，胃肠道溃疡的报告率异常高[ROR 1.94 (1.71-2.21)； IC 0.80 (0.60-0.99)]，出血 [ROR 2.27 (1.86-2.76)； IC 0.99 (0.69-1.28)]，以及阻塞 [ROR 2.19 (1.63-2.95)； IC 0.96 (0.51-1.40)]。FAERS 的药物警戒研究显示，卡培他滨使用者出现胃肠道溃疡、出血和梗阻的报告略有增加，这可能会导致严重或致命的后果。除说明书中描述的不良反应外，还应密切注意胃肠道梗阻，以避免停药或危及生命的结果。版权所有 © 2024 Wang、Meng 和 Liu。

Capecitabine has been reported to be associated with severe gastrointestinal (GI) adverse drug reactions (gastrointestinal ulceration, haemorrhage, and obstruction). However, statistical correlations have not been demonstrated, and specific GI adverse drug reactions, such as GI obstruction, are not listed on its label.We aimed to determine the associations between capecitabine and GI ulceration, haemorrhage, or obstruction among patients with breast cancer by examining data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS).We performed disproportionality analysis of GI ulceration, haemorrhage, and obstruction by evaluating the reporting odds ratio (ROR) and the information component (IC) with their 95% confidence intervals (CIs).We identified 279 patients with capecitabine-associated GI ulceration, haemorrhage, or obstruction reported between 1 January 2004 and 31 December 2020. One-fourth of the cases of GI ulceration, haemorrhage, or obstruction resulted in death. Capecitabine as a drug class had disproportionately high reporting rates for GI ulceration [ROR 1.94 (1.71-2.21); IC 0.80 (0.60-0.99)], haemorrhage [ROR 2.27 (1.86-2.76); IC 0.99 (0.69-1.28)], and obstruction [ROR 2.19 (1.63-2.95); IC 0.96 (0.51-1.40)].Pharmacovigilance research on the FAERS has revealed a slight increase in reports of GI ulceration, haemorrhage, and obstruction in capecitabine users, which may cause serious or deadly consequences. In addition to the adverse reactions described in the package insert, close attention should be paid to GI obstruction to avoid discontinuation or life-threatening outcomes.Copyright © 2024 Wang, Meng and Liu.