目的 分析泽布替尼和阿可替尼上市后的出血不良事件，为临床安全用药提供参考。方法 将FDA不良事件报告系统（FAERS）和加拿大警戒不良反应数据库（CVAROD）中自药品上市时间至2024年第2季度的数据导入R 4.3软件，采用报告比值比法（ROR）对比分析泽布替尼和阿可替尼的出血不良事件信号。单因素和多因素Logistic回归分析合并使用抗血栓药物对出血不良事件的影响。多因素Logistic回归分析泽布替尼和阿可替尼出血风险高低。结果 泽布替尼和阿可替尼出血不良事件涉及的系统器官分类（SOC）基本一致。与阿可替尼相比，泽布替尼出血不良事件呈阳性信号[FAERS:ROR=2.07，95%置信区间（95% CI） =1.79～2.39； CVAROD:ROR=1.50，95% CI=1.05～2.16］。单因素Logistic回归分析表明合并使用抗血栓药物会显著增加出血风险[泽布替尼（FAERS）:OR=3.31，P＜0.001；泽布替尼（CVAROD）:OR=2.70，P=0.007；阿可替尼（FAERS）:OR=2.45，P＜0.001；阿可替尼（CVAROD）:OR=4.23，P=0.001］。多因素Logistic回归分析显示合并使用抗血栓药物为出血的独立危险因素[泽布替尼（CVAROD）:OR=3.16，P=0.003；阿可替尼（FAERS）： OR=2.91，P＜0.001］。与阿可替尼相比，患者服用泽布替尼发生出血的风险显著升高（FAERS:OR=2.90，P=0.029； CVAROD:OR=1.97，P=0.031）。结论 泽布替尼的出血风险可能更高；慎用抗血栓药物，需联合用药时，应加强对出血体征的监测。

Objective To provide reference for clinical safe use through analysis of post-marketing hemorrhagic adverse events of zanubrutinib and acalabrutinib. Methods The raw data from the FDA Adverse Event Reporting System (FAERS) and Canada vigilance adverse reaction online database (CVAROD) between the time of drug lunch to the second quarter of 2024 were imported into R 4.3 software. The reporting odds ratio (ROR) were used to compare the hemorrhagic signals between zanubrutinib and acalabrutinib. The effects of the concurrent use of antithrombotic drugs on hemorrhagic adverse events were assessed by univariate and multivariate Logistic regression analysis. The risk of hemorrhage in patients treated with zanubrutinib or acalabrutinib was compared through logistic regression analysis. Results System organ class involved in the hemorrhagic signals of zanubrutinib and acalabrutinib were similar. Compared with acalabrutinib, zanubrutinib showed a positive signal for hemorrhagic adverse events (FAERS: ROR = 2.07, 95% CI = 1.79-2.39; CVAROD: ROR = 1.50, 95%CI = 1.05-2.16). Univariate Logistic regression showed that the concurrent use of antithrombotic drugs significantly increased the risk of hemorrhage [zanubrutinib (FAERS): OR = 3.31, P < 0.001; zanubrutinib (CVAROD): OR = 2.70, P=0.007; acalabrutinib (FAERS): OR = 2.45, P < 0.001; acalabrutinib (CVAROD): OR = 4.23, P=0.001]. Multivariate Logistic regression indicated that concurrent use of antithrombotic drugs was an independent risk factor [zanubrutinib (CVAROD): OR = 3.16, P=0.003; acalabrutinib (FAERS): OR = 2.91, P < 0.001]. Compared with acalabrutinib, the risk of hemorrhage in patients treated with zanubrutinib was significantly higher (FAERS: OR = 2.90, P=0.029; CVAROD: OR = 1.97, P=0.031). Conclusion Zanubrutinib may have a higher risk of hemorrhage; Use antithrombotic drugs with caution. When combination therapy is required, monitoring of hemorrhage signs should be strengthened.

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