目的 對(duì)引起血栓的抗腫瘤藥物進(jìn)行數(shù)據(jù)挖掘與分析，為臨床安全應(yīng)用抗腫瘤藥物提供參考。方法 基于美國(guó)食品藥品監(jiān)督管理局不良事件報(bào)告系統(tǒng)（FAERS）數(shù)據(jù)庫(kù)提取2004年第1季度至2023年第3季度呈報(bào)的藥物相關(guān)血栓不良事件，從中篩選抗腫瘤藥物相關(guān)數(shù)據(jù)。通過(guò)比例失衡法中報(bào)告比值比（ROR）法篩選以抗腫瘤藥物為首要懷疑藥物的可疑風(fēng)險(xiǎn)信號(hào)。結(jié)果 本研究提取抗腫瘤藥物相關(guān)血栓報(bào)告19 098條，挖掘有效風(fēng)險(xiǎn)信號(hào)296條，涉及抗腫瘤藥物98種，其中藥品說(shuō)明書(shū)尚未提及的血栓不良事件的藥物53種。血栓不良事件報(bào)告數(shù)最多的抗腫瘤藥物是來(lái)那度胺（n＝3 742，ROR＝3.40），ROR值最大的藥物是硫鳥(niǎo)嘌呤（n＝4，ROR＝30.11）。最常見(jiàn)導(dǎo)致藥物相關(guān)血栓的抗腫瘤藥物是靶向藥（n＝6 445，ROR＝10.03），其中以表皮生長(zhǎng)因子受體（EGFR）為靶點(diǎn)的靶向藥報(bào)告數(shù)最多，如西妥昔單抗（n＝534）。最易引起藥物相關(guān)血栓的第二大類(lèi)抗腫瘤藥物為細(xì)胞毒類(lèi)藥物，其中以作用于DNA結(jié)構(gòu)的藥物最常見(jiàn)，如順鉑（n＝635）?？鼓[瘤藥物相關(guān)血栓發(fā)生中位時(shí)間為1.93個(gè)月，主要發(fā)生在首次用藥后的前3個(gè)月內(nèi)（75.71%），尤其第2個(gè)月占比（45.71%）較高。細(xì)胞毒性抗腫瘤藥物發(fā)生血栓不良事件中位時(shí)間最短（1.75個(gè)月），而激素類(lèi)抗腫瘤藥物（3.84個(gè)月）和保骨藥（6.33個(gè)月）發(fā)生血栓不良事件中位時(shí)間最長(zhǎng)。結(jié)論 靶向藥是引起血栓不良事件報(bào)告數(shù)最多的一類(lèi)藥物，遠(yuǎn)高于傳統(tǒng)化療藥。隨著新型抗腫瘤藥物不斷更新上市，臨床需高度關(guān)注這類(lèi)藥物引起的血栓風(fēng)險(xiǎn)。首次用藥后的前3個(gè)月是重點(diǎn)監(jiān)測(cè)時(shí)期，醫(yī)務(wù)人員應(yīng)提高警惕，隨時(shí)做好應(yīng)對(duì)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

湖南省衛(wèi)生健康委衛(wèi)生科研課題(D202313017815);湖南省腫瘤醫(yī)院攀登計(jì)劃項(xiàng)目(YF2021004);湖南省自然科學(xué)基金資助項(xiàng)目(2024JJ8218)