基于FAERS数据库的戈沙妥珠单抗不良事件信号挖掘与分析
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作者单位:

1.玉林市第一人民医院,药物临床试验机构,广西 玉林,537000;2.玉林市第一人民医院,临床药学科,广西 玉林,537000;3.中南大学湘雅医院 药学部, 湖南 长沙,410008

作者简介:

梁春宏,男,硕士,副主任药师,研究方向为临床药理学。

通讯作者:

肖笛,女,博士,副主任药师,研究方向为临床药学、药物基因组学。

中图分类号:

R979.1;R969

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Signals mining and analysis of adverse events for sacituzumab govitecan based on FAERS database
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Affiliation:

1.Drug Clinical Trial Institution, the First People's Hospital of Yulin City, Yulin, 537000, Guangxi, China;2.Department of Clinical Pharmacy, the First People's Hospital of Yulin City, Yulin, 537000, Guangxi, China;3.Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China

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    摘要:

    目的 挖掘戈沙妥珠单抗上市后药品不良事件(ADE)阳性信号,为该药的安全性评价提供循证依据。方法 检索美国食品药品监督管理局不良事件报告系统(FAERS)2020年第二季度至2024年第二季度戈沙妥珠单抗相关ADE报告,采用比例失衡法进行信号挖掘,并针对ADE报告的性别、年龄差异等进行亚组分析。结果 共纳入3 332份以戈沙妥珠单抗为首要怀疑药物的ADE报告,检测到69个ADE信号,涉及17个系统器官分类(SOC)。报告以女性患者居多,ADE的中位发生时间为用药后第14天,男性患者的严重ADE报告比例、危及生命报告比例及住院报告比例均显著高于女性患者(P<0.001)。累及SOC主要包括全身性疾病及给药部位各种反应(40.56%)、血液及淋巴系统疾病(18.83%)、各类检查(13.01%)、胃肠系统疾病(12.78%)等。报告频次较高的ADE信号主要包括疾病进展、死亡、腹泻、中性粒细胞减少症、体重波动等;相关度较高的ADE信号包括中性粒细胞减少性结肠炎、胆碱能综合征、体重波动、血管装置阻塞等。识别出26个药品说明书未记载的信号,涉及血管与淋巴管类疾病、肾脏及泌尿系统疾病、眼器官疾病等SOC,以及心率加快、大肠穿孔、胆汁淤积等具体ADE信号。结论 本研究揭示了戈沙妥珠单抗相关ADE的性别、年龄、发生时间及SOC分布特征,完善了戈沙妥珠单抗的安全性信息,为临床用药决策和不良反应管理提供了科学依据。

    Abstract:

    Objective To explore the positive post-marketing adverse drug event (ADE) signals of sacituzumab govitecan, in order to provide a basis for the safety assessment.Methods Sacituzumab govitecan-associated ADE reports from Q2 2020 to Q2 2024 were obtained from the FDA Adverse Event Reporting System (FAERS) for ADE signal mining using the disproportionality method. Furthermore, age and gender differences were investigated in the reporting of ADEs by subgroups.Results A total of 3 332 ADE reports primarily suspected to be associated with sacituzumab govitecan were included, with 69 ADE signals detected across 17 system organ classes (SOCs). The majority of reports involved female patients. The median time to ADE occurrence was 14 days after medication. Male patients showed significantly higher proportions of serious reports and greater risks of life-threatening ADEs and hospitalization-requiring events compared to female patients (P<0.001). The most frequently affected SOCs included general disorders and administration site conditions (40.56%), blood and lymphatic system disorders (18.83%), investigations (13.01%), and gastrointestinal disorders (12.78%). The most frequently reported ADE signals were disease progression, death, diarrhea, neutropenia and weight fluctuation. The signals with the highest relevance were neutropenic colitis, cholinergic syndrome, weight fluctuation, and vascular device obstruction. 26 ADE signals not mentioned in drug labelswere identified, involving SOCs such as vascular and lymphatic vascular disorders, renal and urinary disorders, and eye disorders, as well as specific signals such as accelerated heart rate, perforation of the large intestine, and cholestasis.Conclusion In this study, the gender, age, time of occurrence, and system-organ distribution characteristics of Sacituzumab govitecan-related ADEs were discovered. The results of the study contribute to the drug's safety information and provide a scientific basis for clinical medication decision-making and adverse reaction management.

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梁春宏,张学艳,周丽娟,彭评志,张维权,肖笛.基于FAERS数据库的戈沙妥珠单抗不良事件信号挖掘与分析[J].肿瘤药学,2025,15(3):403-411

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