The PTs with EBGM>25.00.

BackgroundDefinity significantly enhances the diagnostic accuracy of echocardiography but raises ongoing safety concerns. This study aimed to explore potential adverse events (AEs) associated with Definity in real-world settings by analyzing data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).MethodsWe retrospectively extracted AE reports from the FAERS database between 2004 and the first quarter of 2024. Disproportionality analyses using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) were conducted to identify signals potentially associated with Definity. Univariate and multivariate logistic regression analyses were performed as sensitivity analyses to assess potential risk factors for Definity-related AEs.ResultsA total of 4460 reports with Definity as the “primary suspected” drug were included. We identified 104 statistically significant signals at PT level, including common AEs such as back pain and muscle spasms, as well as exploratory signals not listed on the drug label, such as eye movement disorder and renal pain. It is noteworthy that 21 signals did not retain significance following Bonferroni correction. These AEs spanned 25 System Organ Classes (SOCs). In reports with available time-to-onset data, most events occurred within 30 days of administration, while some were reported at longer intervals. Moreover, logistic regression analysis indicated that both gender and body weight were independent risk factors associated with Definity-related AE.ConclusionThis study provides exploratory insights into potential AEs associated with Definity based on real-world pharmacovigilance data. While most signals are consistent with known safety profiles, several emerging signals warrant further investigation and clinical awareness. These findings may contribute to ongoing risk management and pharmacovigilance efforts.背景：超声造影剂Definity可显著提升超声心动图的诊断准确性，但同时也引发了持续的安全性担忧。本研究旨在通过分析美国食品药品监督管理局（U.S. Food and Drug Administration, FDA）不良事件报告系统（Adverse Event Reporting System, FAERS）的数据，探索真实世界中与Definity相关的潜在不良事件（Adverse Events, AEs）。 方法：本研究回顾性提取了2004年至2024年第一季度FAERS数据库中的不良事件报告。采用报告比值比（reporting odds ratio, ROR）、比例报告比（proportional reporting ratio, PRR）、贝叶斯置信传播神经网络（Bayesian Confidence Propagation Neural Network, BCPNN）及多项目伽马泊松收缩器（multi-item gamma Poisson shrinker, MGPS）进行不成比例分析，以识别与Definity潜在相关的信号。同时开展单因素及多因素logistic回归分析作为敏感性分析，以评估Definity相关不良事件的潜在危险因素。 结果：最终纳入以Definity为"首要疑似用药"的报告共4460份。在首选术语（Preferred Term, PT）层面共识别出104个具有统计学意义的信号，涵盖背痛、肌肉痉挛等常见不良事件，以及药品说明书未收录的探索性信号，如眼球运动障碍、肾区疼痛。值得注意的是，经邦费罗尼校正（Bonferroni correction）后，有21个信号不再具有统计学显著性。上述不良事件共涉及25个系统器官分类（System Organ Classes, SOCs）。在具备发病时间数据的报告中，多数不良事件发生于给药后30天内，但亦有部分报告的发病间隔较长。此外，logistic回归分析显示，性别与体重均为与Definity相关不良事件相关的独立危险因素。 结论：本研究基于真实世界药物警戒数据，为Definity相关潜在不良事件提供了探索性见解。尽管多数信号与已知的安全性特征相符，但若干新出现的信号仍需进一步研究及临床关注。本研究结果可为当前的风险管理及药物警戒工作提供参考。