PDF(Pubmed)
Abstract：
As the world\'s first oral nuclear export inhibitor, selinexor is increasingly being used in clinical applications for malignant tumors. However, there is no extensive exploration on selinexor\'s adverse events (ADEs), necessitating a real-word assessment of its clinical medication safety. FAERS data (July 2019-June 2023) were searched for selinexor ADE reports across all indications. Use the system organ class (SOC) and preferred terms (PT) from the medical dictionary for regulatory activities (MedDRA) to describe, categorize, and statistic ADEs. Disproportionality analysis was employed through calculation of reporting odds ratio (ROR) and proportional reporting ratio (PRR). Based on total of 4392 selinexor related ADE reports as the primary suspect (PS), of which 2595 instances were severe outcomes. The predominant ADEs included gastrointestinal disorders, myelosuppression symptoms, and various nonspecific manifestations. 124 signals associated with selinexor ADE were detected, and 10 of these top 15 signals were not included into the instructions. Our study provides real-world evidence regarding the drug safety of selinexor, which is crucial for clinicians to safeguard patients\' health.
摘要：
作为世界上第一个口服核出口抑制剂,selinexor越来越多地用于恶性肿瘤的临床应用。然而,关于selinexor不良事件(ADEs)没有广泛的探索，有必要对其临床用药安全性进行真实评估。在所有适应症中搜索了FAERS数据（2019年7月至2023年6月）的selinexorADE报告。使用医学词典中的系统器官类别（SOC）和首选术语（PT）来描述调节活动（MedDRA），归类,和统计ADE。通过计算报告比值比（ROR）和比例报告比（PRR）采用不成比例分析。根据主要嫌疑人（PS）总共4392份selinexor相关ADE报告，其中2595例为严重结局.主要的ADE包括胃肠道疾病，骨髓抑制症状,和各种非特异性表现。检测到124个与selinexorADE相关的信号，这些前15个信号中有10个没有包含在说明书中。我们的研究提供了有关selinexor药物安全性的真实证据，这对于临床医生保护患者的健康至关重要。
