■据报道,卡培他滨与严重的胃肠道(GI)不良反应(胃肠道溃疡,出血,和阻碍)。然而,统计相关性尚未得到证明,和特定的胃肠道不良反应,比如胃肠道阻塞,没有在标签上列出。
■我们旨在确定卡培他滨与胃肠道溃疡之间的关联,出血,通过检查美国食品和药物管理局不良事件报告系统(FAERS)的数据,或在乳腺癌患者中阻塞。
■我们对胃肠道溃疡进行了不相称性分析,出血,通过评估报告比值比(ROR)和信息成分(IC)及其95%置信区间(CI)来进行阻塞。
■我们确定了279例卡培他滨相关消化道溃疡患者,出血,或在2004年1月1日至2020年12月31日期间报告的梗阻。四分之一的胃肠道溃疡病例,出血,或阻塞导致死亡。卡培他滨作为一类药物,胃肠道溃疡的报告率不成比例地高[ROR1.94(1.71-2.21);IC0.80(0.60-0.99)],出血[ROR2.27(1.86-2.76);IC0.99(0.69-1.28)],和梗阻[ROR2.19(1.63-2.95);IC0.96(0.51-1.40)]。
■对FAERS的药物警戒研究表明,胃肠道溃疡的报告略有增加,出血,卡培他滨使用者的阻塞,这可能会造成严重或致命的后果。除了包装说明书中描述的不良反应外,应密切关注胃肠道梗阻,以避免停药或危及生命的结局.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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).
UNASSIGNED: 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)].
UNASSIGNED: 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.