他莫昔芬对女性乳腺癌患者的年龄相关不良反应:来自FDA不良事件报告系统的见解

IF 1 4区 医学 Q4 ONCOLOGY
Yuting Chen, Weitao Lu, Li Xin, Xu Tang, Jing Wang, Huancun Feng
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引用次数: 0

摘要

背景:他莫昔芬是治疗激素受体阳性乳腺癌(BC)的有效药物。尽管它有效,但也有许多不良反应的报道。然而,他莫昔芬相关不良事件(ADEs)与患者年龄之间的关系尚不清楚。目的通过识别女性乳腺癌患者与他莫昔芬治疗相关的年龄特异性不良反应,加强临床用药指导和药物安全性,为循证临床实践提供更坚实的基础。方法提取2004年第一季度至2023年第二季度FAERS数据库中有关他莫昔芬的不良反应报告。报告优势比(ROR)数据分析策略用于挖掘信号强度,该信号强度代表与他莫昔芬相关的ade的年龄差异。结果他莫昔芬治疗女性BC的有效ADE信号在绝经前、围绝经期和绝经后分别为338个、847个和1525个。我们的研究显示,在女性BC患者中,他莫昔芬治疗ade的三个年龄组存在年龄差异。围绝经期和绝经后接受他莫昔芬治疗的妇女表现出明显更高的药物不良反应发生率,特别是涉及胃肠道、肾脏/泌尿系统、血液/淋巴系统、内分泌功能和免疫反应。特别值得关注的是,与耳部和迷宫症相关的ADEs仅在围绝经期报道。结论他莫昔芬相关ADE信号存在年龄差异。绝经前、围绝经期和绝经后不同系统BC患者的他莫昔芬相关ade有显著差异。为了保证药物的安全性,我们应该认识到ade的年龄相关性差异,并采取相应的预防措施,以减少严重ade的发生率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Age-related adverse effects of Tamoxifen in female breast cancer patients: Insights from the FDA's adverse event reporting system.

BackgroundTamoxifen is an effective treatment for hormone receptor-positive breast cancer (BC). Despite its effectiveness, there have been many reports of adverse reaction. However, the relationship between Tamoxifen-related adverse events (ADEs) and patient age remains unclear.AimTo enhance clinical medication guidance and drug safety by identifying age-specific ADEs associated with Tamoxifen therapy in female breast cancer patients, thereby offering a more robust foundation for evidence-based clinical practice.MethodsADEs reports of Tamoxifen from the FAERS database were extracted from the first quarter of 2004 to the second quarter of 2023. Reporting odds ratio (ROR) data analysis strategy was used for mining signal strength that represents age differences in ADEs related to Tamoxifen.ResultsThe number of efficient ADE signals associated with Tamoxifen for female BC included in the analysis was 338 in premenopausal women, 847 in perimenopause and 1525 in postmenopause respectively. Our study showed age differences in three age groups of ADEs with Tamoxifen in female BC. Perimenopausal and postmenopausal women receiving tamoxifen therapy demonstrated a significantly higher incidence of adverse drug reactions, particularly involving the gastrointestinal tract, renal/urinary systems, hematologic/lymphatic systems, endocrine functions, and immune responses. It was particularly concerned that ADEs associated with ear and labyrinth disorders had only been reported in perimenopause.ConclusionAge differences was detected in ADE signals related to Tamoxifen. There were significant differences in Tamoxifen related ADEs of premenopausal, perimenopausal and postmenopausal women with BC in different systems. To ensure the safety of medicines, we should be aware of the age-related differences in ADEs and take appropriate preventive measures to reduce incidence of serious ADEs.

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来源期刊
CiteScore
2.70
自引率
7.70%
发文量
276
期刊介绍: Journal of Oncology Pharmacy Practice is a peer-reviewed scholarly journal dedicated to educating health professionals about providing pharmaceutical care to patients with cancer. It is the official publication of the International Society for Oncology Pharmacy Practitioners (ISOPP). Publishing pertinent case reports and consensus guidelines...
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