Jiao Yan, Liu Yahui, Jin Meng
Department of Hepatobiliary and Pancreatic Surgery, General Surgery Center, The First Hospital of Jilin University, Changchun, 130021, China.
Department of Radiation Oncology, Jilin Provincial Key Laboratory of Radiation Oncology & Therapy, The First Hospital of Jilin University, Changchun, 130021, China.
Sci Rep. 2024 Dec 3;14(1):30155. doi: 10.1038/s41598-024-81903-z.
Indocyanine green (ICG) is a diagnostic dye commonly used in medical imaging and liver function monitoring. Given its widespread use, there is a need for detailed evaluations of its adverse drug reactions in real-world settings. As the comprehensive overview of its safety profile is very limited, this study aimed to analyze the adverse events (AEs) associated with ICG using data from the Food and Drug Administration Adverse Event Reporting System (FAERS). Data between 2004Q1 and 2023Q4 were extracted from the FAERS database. Signal detection was performed using various disproportionality analysis algorithms, including reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and multiitem gamma Poisson shrinker. During the study period, a total of 62 ICG-related AEs were reported in the FAERS database. Significant clinical adverse reactions included anaphylactic shock (ROR: 92.10, 95% confidence interval (CI): 37.71-224.96), procedural hypotension (ROR: 1397.27, 95% CI: 443.31-4404.08), and urticaria (ROR: 10.88, 95% CI: 4.02-29.42). This study provides valuable insights into the safety profile of ICG, highlighting the need for further monitoring to ensure its safe clinical use in clinical practice. Ongoing pharmacovigilance and large-scale studies are warranted to fully understand the potential risks associated with ICG.
吲哚菁绿（ICG）是一种常用于医学成像和肝功能监测的诊断染料。鉴于其广泛使用，有必要在实际应用中对其药物不良反应进行详细评估。由于对其安全性概况的全面概述非常有限，本研究旨在使用美国食品药品监督管理局不良事件报告系统（FAERS）的数据，分析与ICG相关的不良事件（AE）。从FAERS数据库中提取了2004年第一季度至2023年第四季度的数据。使用各种不成比例分析算法进行信号检测，包括报告比值比（ROR）、比例报告比、贝叶斯置信传播神经网络和多项目伽马泊松收缩器。在研究期间，FAERS数据库中共报告了62例与ICG相关的不良事件。显著的临床不良反应包括过敏性休克（ROR：92.10，95%置信区间（CI）：37.71 - 224.96）、术中低血压（ROR：1397.27，95%CI：443.31 - 4404.08）和荨麻疹（ROR：10.88，95%CI：4.02 - 29.42）。本研究为ICG的安全性概况提供了有价值的见解，强调了进一步监测以确保其在临床实践中安全使用的必要性。需要持续的药物警戒和大规模研究来全面了解与ICG相关的潜在风险。
