背景:随着癌症患者使用BCR-ABL1酪氨酸激酶抑制剂(TKIs)的增加,不良事件(AE)引起了相当大的兴趣。我们进行了这项药物警戒研究,以使用食品和药物管理局不良事件报告系统(FAERS)数据库评估癌症患者BCR-ABL1TKIs的不良事件。
方法:要从FAERS数据库查询AE报告,我们使用了OpenVigil2.1。然后采用描述性分析来描述TKI相关AE报告的特征。我们还利用不相称性分析通过计算比例报告比(PRR)和报告比值比(ROR)来检测安全性信号。
结果:来自FAERS数据库,共检索到85,989份不良事件报告,鉴定出3,080个显著的AE信号。具体来说,伊马替尼,尼洛替尼,达沙替尼,博舒替尼,和普纳替尼的显著AE信号分别为1,058,813,232,186和791.这些显著信号被进一步分类为26个系统器官类别(SOC)。伊马替尼和普纳替尼的AE信号主要与一般疾病和给药部位状况有关。另一方面,尼洛替尼,达沙替尼,和博舒替尼主要与调查有关,呼吸,胸部和纵隔疾病,和胃肠道疾病,分别。值得注意的是,在伊马替尼中观察到245、278、47、55和253的新信号,尼洛替尼,达沙替尼,博舒替尼,和普纳替尼,分别。
结论:这项研究的结果表明,在五个BCR-ABL1TKI中,AE信号存在差异。此外,每个BCR-ABL1TKI显示几个新信号。这些发现为临床医生提供了有价值的信息,旨在降低BCR-ABL1TKI治疗期间的AE风险。
BACKGROUND: With the increased use of BCR-ABL1 tyrosine kinase inhibitors (TKIs) in cancer patients, adverse events (AEs) have garnered considerable interest. We conducted this pharmacovigilance
study to evaluate the AEs of BCR-ABL1 TKIs in cancer patients using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
METHODS: To query AE reports from the FAERS database, we used OpenVigil 2.1. Descriptive analysis was then employed to describe the characteristics of TKIs-associated AE reports. We also utilized the disproportionality analysis to detect safety signals by calculating the proportional reporting ratio (PRR) and reporting odds ratios (ROR).
RESULTS: From the FAERS database, a total of 85,989 AE reports were retrieved, with 3,080 significant AE signals identified. Specifically, imatinib, nilotinib,
dasatinib, bosutinib, and ponatinib had significant AE signals of 1,058, 813, 232, 186, and 791, respectively. These significant signals were further categorized into 26 system organ classes (SOCs). The AE signals of imatinib and ponatinib were primarily associated with general disorders and administration site conditions. On the other hand, nilotinib,
dasatinib, and bosutinib were mainly linked to investigations, respiratory, thoracic and mediastinal disorders, and gastrointestinal disorders, respectively. Notably, new signals of 245, 278, 47, 55, and 253 were observed in imatinib, nilotinib,
dasatinib, bosutinib, and ponatinib, respectively.
CONCLUSIONS: The results of this
study demonstrated that AE signals differ among the five BCR-ABL1 TKIs. Furthermore, each BCR-ABL1 TKI displayed several new signals. These findings provide valuable information for clinicians aiming to reduce the risk of AEs during BCR-ABL1 TKI treatment.