目的 分析澤布替尼和阿可替尼上市后的出血不良事件，為臨床安全用藥提供參考。方法 將FDA不良事件報告系統(tǒng)（FAERS）和加拿大警戒不良反應數(shù)據(jù)庫（CVAROD）中自藥品上市時間至2024年第2季度的數(shù)據(jù)導入R 4.3軟件，采用報告比值比法（ROR）對比分析澤布替尼和阿可替尼的出血不良事件信號。單因素和多因素Logistic回歸分析合并使用抗血栓藥物對出血不良事件的影響。多因素Logistic回歸分析澤布替尼和阿可替尼出血風險高低。結(jié)果 澤布替尼和阿可替尼出血不良事件涉及的系統(tǒng)器官分類（SOC）基本一致。與阿可替尼相比，澤布替尼出血不良事件呈陽性信號[FAERS:ROR=2.07，95%置信區(qū)間（95% CI） =1.79～2.39； CVAROD:ROR=1.50，95% CI=1.05～2.16］。單因素Logistic回歸分析表明合并使用抗血栓藥物會顯著增加出血風險[澤布替尼（FAERS）:OR=3.31，P＜0.001；澤布替尼（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回歸分析顯示合并使用抗血栓藥物為出血的獨立危險因素[澤布替尼（CVAROD）:OR=3.16，P=0.003；阿可替尼（FAERS）： OR=2.91，P＜0.001］。與阿可替尼相比，患者服用澤布替尼發(fā)生出血的風險顯著升高（FAERS:OR=2.90，P=0.029； CVAROD:OR=1.97，P=0.031）。結(jié)論 澤布替尼的出血風險可能更高；慎用抗血栓藥物，需聯(lián)合用藥時，應加強對出血體征的監(jiān)測。

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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