环孢菌素是一种免疫抑制剂,用于预防肾脏器官排斥反应,肝脏,心脏同种异体移植.本研究旨在通过分析美国食品和药物管理局不良事件报告系统(FAERS)中与环孢素相关的不良事件(AE)来评估环孢素的安全性。为了检测与环孢菌素相关的AE,在FAERS数据库上使用四种算法进行药物警戒分析:报告比值比(ROR),比例报告比率(PRR),贝叶斯置信度传播神经网络(BCPNN),和经验贝叶斯几何平均值(EBGM)。对从FAERS数据库中提取的数据进行了统计分析,涵盖2013年至2022年的19,582例病例报告。在这些案例中,确定了3,911个AE,与环孢素相关的476是主要的可疑药物。环孢菌素诱导的AE靶向27个系统器官类别(SOCs)。值得注意的是,SOC级别的最高病例包括眼部疾病,损伤,中毒,和手术并发症,以及免疫系统紊乱,所有这些都列在环孢菌素标签上。此外,我们发现了与肝胆疾病相关的新的潜在AE,在其他人中。此外,意外药物不良反应(ADR),如胆道吻合并发症和精子进行性运动性下降,已确定。重要的是,环孢菌素标签上没有提到这些新发现的不良反应,参与了伤害,中毒,和手术并发症,和SOC级别的调查。该研究使用FAERS数据库的药物警戒分析来确定与环孢菌素相关的新的和意外的潜在ADR。可以为环孢素的安全使用提供安全提示。
Cyclosporine is an immunosuppressant used to prevent organ rejection in kidney, liver, and heart allogeneic transplants. This study aimed to assess the safety of
cyclosporine through the analysis of adverse events (AEs) related to
cyclosporine in the US Food and Drug Administration Adverse Event Reporting System (FAERS). To detect AEs associated with cyclosporine, a pharmacovigilance analysis was conducted using four algorithms on the FAERS database: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayes geometric mean (EBGM). A statistical analysis was performed on data extracted from the FAERS database, covering 19,582 case reports spanning from 2013 to 2022. Among these cases, 3,911 AEs were identified, with 476 linked to
cyclosporine as the primary suspected drug. Cyclosporin-induced AEs targeted 27 System Organ Classes (SOCs). Notably, the highest case at the SOC level included eye disorders, injury, poisoning, and procedural complications, as well as immune system disorders, all of which are listed on the cyclosporine label. Furthermore, we discovered novel potential AEs associated with hepatobiliary disorders, among others. Moreover, unexpected adverse drug reactions (ADRs), such as biliary anastomosis complication and spermatozoa progressive motility decrease, were identified. Importantly, these newly identified ADRs were not mentioned on the cyclosporine label, which were involved in injury, poisoning, and procedural complications, and investigations at the SOC level. The study used pharmacovigilance analysis of FAERS database to identify new and unexpected potential ADRs relating to cyclosporine, which can provide safety tips for the safe use of
cyclosporine.