■本研究分析了布鲁顿酪氨酸激酶(BTK)抑制剂治疗B细胞淋巴瘤引起的出血不良事件(AE),根据美国食品和药物管理局不良事件报告系统(FAERS)的报告。
■与BTK抑制剂相关的出血不良事件(包括依鲁替尼,扎努布替尼,和acalabrutinib)从2013年第一季度到2023年第三季度进行提取。报告比值比(ROR)和比例报告比(PRR)。调节活动医学词典(MedDRA)术语的首选术语(PT)映射到系统器官类别术语(SOC)术语,并分析与三种BTK抑制剂相关的出血AE。
■共纳入463例出血不良事件。挫伤,皮下出血,血尿,和脑出血包括在PT中。存在血尿,并报告了硬膜下血肿。伊布替尼(病例数=10,696)的出血不良事件发生率高于扎努布替尼(病例数=213)和阿卡拉布替尼(病例数=314)。
■我们的研究结果表明,在各种情况下与BTK抑制剂相关的出血不良事件强调了谨慎临床决策的必要性。特别是在神经系统疾病中,受伤,中毒,手术并发症,血管疾病,和其他人。
UNASSIGNED: This study analyzed the bleeding adverse events (AEs) resulting from the treatment of B-cell lymphoma with Bruton tyrosine kinase (BTK) inhibitors, according to reports in the US Food and Drug Administration\'s Adverse Event Reporting System (FAERS).
UNASSIGNED: Bleeding AEs associated with BTK inhibitors (including ibrutinib, zanubrutinib, and acalabrutinib) from the first quarter of 2013 to the third quarter of 2023 were extracted. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) were reported. Preferred Terms (PTs) of Medical Dictionary for Regulatory Activities (MedDRA) terms were mapped to System Organ Class terms (SOC) terms and analyzed bleeding AEs associated with three BTK inhibitors.
UNASSIGNED: A total of 463 cases of bleeding AEs were included. Contusion, subcutaneous hemorrhage, hematuria, and cerebral hemorrhage were included in PTs. Blood urine was present and subdural hematoma were also reported. The incidence of bleeding AEs was higher with ibrutinib (Case number = 10,696) than with zanubrutinib (Case number = 213) and acalabrutinib (Case number = 314).
UNASSIGNED: Our findings indicate that bleeding AEs linked to BTK inhibitors in various conditions underscore the need for cautious clinical decision-making, particularly in nervous system disorders, injuries, poisoning, surgical complications, vascular disorders, and others.