| 汪雁琳,朱 骥.伊立替康在消化系统恶性肿瘤中的安全性：基于FAERS数据库的2004—2024年真实世界研究[J].中国肿瘤,2025,34(5):397-407. |
| 伊立替康在消化系统恶性肿瘤中的安全性：基于FAERS数据库的2004—2024年真实世界研究 |
| Safety of Irinotecan in Patients with Digestive System Cancers： a Real-World Study from FAERS Database，2004—2024 |
| 投稿时间：2025-03-11 |
| DOI：10.11735/j.issn.1004-0242.2025.05.A010 |
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| 中文关键词: 伊立替康 拓扑异构酶-Ⅰ抑制剂 消化系统恶性肿瘤 不良事件 食品药品监督管理局不良事件报告系统数据库 |
| 英文关键词:irinotecan topoisomerase Ⅰ inhibitor digestive system cancer adverse events Food and Drug Administration Adverse Event Reporting System database |
| 基金项目:国家卫生健康委员会科研基金（省部共建）（WKJ-ZJ-2305）；浙江省科技厅重点研发“尖兵”计划（2022C03015） |
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| 中文摘要: |
| 摘 要：［目的］ 系统分析伊立替康相关不良事件信号，为临床安全用药提供参考。［方法］ 基于美国食品药品监督管理局不良事件报告系统（Food and Drug Administration Adverse Event Reporting System，FAERS）数据库，回顾性分析2004年第1季度至2024年第4季度的伊立替康相关不良事件报告。数据去重后，采用报告比值比、比例报告比、贝叶斯置信传播神经网络和经验贝叶斯几何均值4种不良事件信号挖掘方法进行分析，并按年龄（≥65 岁 vs <65 岁）及结局（死亡 vs 非死亡）进行亚组分析。［结果］ 共检索到8 456例伊立替康相关病例，涉及27 177个不良事件。报告的常见不良事件包括腹泻、恶心、中性粒细胞减少、呕吐和乏力。研究发现新的显著信号包括细胞介导的细胞毒性、化脓性肌炎、神经性肌肉萎缩、给药部位回忆反应和缺血性神经病变等。亚组分析显示：老年患者腹泻、中性粒细胞减少和白细胞减少症等报告频率更高，年轻患者恶心、呕吐和周围神经病变等报告频率更高。伊立替康相关不良事件的中位发生时间为31 d，49.8% 发生于治疗首月。［结论］ 应重视伊立替康相关不良事件，临床使用伊立替康治疗消化系统恶性肿瘤时应密切关注腹泻、恶心、中性粒细胞减少等症状，减少用药风险。 |
| 英文摘要: |
| Abstract： ［Purpose］ To analyze irinotecan-related adverse events (AEs) signals， to provide references for clinically safe prescribing practices. ［Methods］ A retrospective pharmacovigilance analysis was conducted using Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the last quarter of 2024. After duplicate removal， four disproportionality analysis methods were applied： reporting odds ratio (ROR)， proportional reporting ratio (PRR)， Bayesian confidence propagation neural network (BCPNN)， and empirical Bayes geometric mean (EBGM)， and subgroups were analyzed by age (≥65 years old vs <65 years old) and outcome (death vs non-death). ［Results］ A total of 8 456 irinotecan-related reports comprising 27 177 AEs were identified. The most frequently reported AEs included diarrhea， nausea， neutropenia， vomiting， and fatigue. Additionally， several unexpected and significant AEs signals were detected， such as cell-mediated cytotoxicity， pyomyositis， neuropathic muscular atrophy， administration site recall reaction and ischemic neuropathy. Subgroup analysis indicated that elderly patients showed higher reported frequencies of diarrhea， neutropenia and leukopenia， while younger patients had more frequent reports of nausea， vomiting and peripheral neuropathy. The median time to AEs onset was 31 d， with 49.8% occurring within the first month of treatment. ［Conclusion］ The AEs related to irinotecan should be paid attention to. When using irinotecan for the treatment of digestive system cancer， symptoms such as diarrhea， nausea and neutropenia should be closely monitored to reduce the risk of drug use. |
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