这项研究分析了与巴利昔单抗相关的不良药物事件(ADE),来自食品和药物管理局不良事件报告系统(FAERS)数据库,从2004年第一季度到2023年第四季度。我们收集了2004年第一季度至2023年第四季度巴利昔单抗的ADE数据。标准化后,我们采用了几种信号量化方法进行分析,例如报告赔率比(ROR),比例报告比率(PRR),神经网络的贝叶斯置信倾向(BCPNN),和经验贝叶斯几何平均值(EBGM)。在对1520个ADE的分析报告中,巴利昔单抗是主要嫌疑人,我们在24个系统器官分类(SOC)中确定了295个首选术语。调查了3个最普遍的SOC(n=1403,ROR2.84,PRR2.54,IC1.34,EBGM2.54),感染和侵染(n=1198,ROR2.85,PRR2.59,IC1.37,EBGM2.59),和肾脏和泌尿系统疾病(n=903,ROR6.01,PRR5.48,IC2.45,EBGM5.47)。血肌酐升高和发热是巴利昔单抗最常报告的不良事件(AE)。和巨细胞病毒感染也表现出显著的信号强度。值得注意的是,这项研究揭示了一些超出巴利昔单抗药物说明书的不良反应,比如二尖瓣钙化,舒张功能障碍,盆腔液收集,睾丸肿胀,软组织坏死,和肌肉坏死.虽然巴利昔单抗提供治疗益处,它有几个不良反应的风险。临床医生应监测患者血清肌酐水平升高的迹象,发烧,巨细胞病毒感染,过敏性休克,二尖瓣钙化,舒张功能障碍,盆腔液收集,睾丸肿胀,软组织坏死,肌肉坏死,以及临床使用期间的其他事件。
This study analyzed adverse drug events (ADEs) associated with
basiliximab, sourced from the Food and Drug Administration Adverse Event Reporting System (FAERS) database, spanning the first quarter of 2004 to the fourth quarter of 2023. We collected ADE data for
basiliximab from 2004 Q1 to 2023 Q4. After standardization, we employed several signal quantification methods for analysis, such as the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propensity for Neural Networks (BCPNN), and empirical bayes geometric mean (EBGM). In this analysis of 1520 ADEs reports citing
basiliximab as the primary suspect, we identified 295 preferred terms across 24 system organ classifications (SOCs). The 3 most prevalent SOCs were investigated (n = 1403, ROR 2.84, PRR 2.54, IC 1.34, EBGM 2.54), infections and infestations (n = 1198, ROR 2.85, PRR 2.59, IC 1.37, EBGM 2.59), and renal and urinary disorders (n = 903, ROR 6.01, PRR 5.48, IC 2.45, EBGM 5.47). Increased blood creatinine and pyrexia were the most frequently reported adverse events (AEs) associated with basiliximab, and cytomegalovirus infection also demonstrated significant signal intensity. Notably, this study revealed some adverse reactions beyond
basiliximab drug instructions, such as mitral valve calcification, diastolic dysfunction, pelvic fluid collection, testicular swelling, soft tissue necrosis, and muscle necrosis. Although
basiliximab offers therapeutic benefits, it carries the risk of several adverse reactions. Clinicians should monitor patients for signs of increased serum creatinine level, fever, cytomegalovirus infection, anaphylactic shock, mitral valve calcification, diastolic dysfunction, pelvic fluid collection, testicular swelling, soft tissue necrosis, muscle necrosis, and other events during clinical use.