目的 对引起血栓的抗肿瘤药物进行数据挖掘与分析，为临床安全应用抗肿瘤药物提供参考。方法 基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库提取2004年第1季度至2023年第3季度呈报的药物相关血栓不良事件，从中筛选抗肿瘤药物相关数据。通过比例失衡法中报告比值比（ROR）法筛选以抗肿瘤药物为首要怀疑药物的可疑风险信号。结果 本研究提取抗肿瘤药物相关血栓报告19 098条，挖掘有效风险信号296条，涉及抗肿瘤药物98种，其中药品说明书尚未提及的血栓不良事件的药物53种。血栓不良事件报告数最多的抗肿瘤药物是来那度胺（n＝3 742，ROR＝3.40），ROR值最大的药物是硫鸟嘌呤（n＝4，ROR＝30.11）。最常见导致药物相关血栓的抗肿瘤药物是靶向药（n＝6 445，ROR＝10.03），其中以表皮生长因子受体（EGFR）为靶点的靶向药报告数最多，如西妥昔单抗（n＝534）。最易引起药物相关血栓的第二大类抗肿瘤药物为细胞毒类药物，其中以作用于DNA结构的药物最常见，如顺铂（n＝635）。抗肿瘤药物相关血栓发生中位时间为1.93个月，主要发生在首次用药后的前3个月内（75.71%），尤其第2个月占比（45.71%）较高。细胞毒性抗肿瘤药物发生血栓不良事件中位时间最短（1.75个月），而激素类抗肿瘤药物（3.84个月）和保骨药（6.33个月）发生血栓不良事件中位时间最长。结论 靶向药是引起血栓不良事件报告数最多的一类药物，远高于传统化疗药。随着新型抗肿瘤药物不断更新上市，临床需高度关注这类药物引起的血栓风险。首次用药后的前3个月是重点监测时期，医务人员应提高警惕，随时做好应对措施。

Objective The data mining and analysis of antineoplastic agents-associated thrombosis were conducted to ensure their safe clinical application. Methods Thrombotic events were extracted from the FDA adverse event reporting system (FAERS) database, covering the period from the first quarter of 2004 to the third quarter of 2023. Subsequently, the screening process was conducted to identify events specifically associated with thrombosis caused by antineoplastic agents. The suspicious risk signals where antineoplastic agents were identified as the primary suspect (PS) were screened by the reporting odds ratio (ROR) method. Results A total of 19 098 events and 296 suspicious risk signals were obtained, involving 98 antineoplastic agents. Among these agents, 53 did not have thrombotic adverse events listed in their drug instructions. The antineoplastic agent with the largest number of reports was lenalidomide (n = 3 742, ROR = 3.40), and the largest ROR value was thioguanine (n = 4, ROR = 30.11). The most frequently observed antineoplastic agents associated with thrombosis were targeted agents (n = 6 445, ROR = 10.03), with EGFRtargeted agents being the most commonly reported, particularly cetuximab (n = 534). Cytotoxic drugs, which primarily act on DNA structures, such as cisplatin (n = 635), were the second most common category of antineoplastic agents associated with thrombosis. The median time of occurrence of antineoplastic agents-related thrombus was 1.93 months (75.71%), which mainly occurred within three months after the first medication, and the second month (45.71%) accounted for a relatively high proportion. The median time of thrombotic adverse events was the shortest (1.75 months) for cytotoxic drugs, while the median time of thrombotic adverse events for hormone antitumor drugs (3.84 months) and bone preserving drugs (6.33 months) were longer. Conclusion Targeted agents are the primary class of drugs linked to thrombotic events, surpassing traditional chemotherapy drugs by a significant margin. With emerging anti-tumor drugs constantly being introduced to the market, clinicians must remain vigilant of the potential risk of thrombosis posed by such medications. The three months after the first drug use is the key monitoring period, medical personnel should be vigilant and take countermeasures at any time.

R979.1

湖南省卫生健康委卫生科研课题(D202313017815);湖南省肿瘤医院攀登计划项目(YF2021004);湖南省自然科学基金资助项目(2024JJ8218)