Department of Anesthesiology, The Affiliated Lihuili Hospital, Ningbo University, Ningbo, Zhejiang Province, P. R. China.
Department of Otology and Skull Base Surgery, National Health Commission Key Laboratory of Hearing Medicine (Fudan University), Shanghai, P. R. China.
Medicine (Baltimore). 2024 Aug 30;103(35):e38873. doi: 10.1097/MD.0000000000038873.
Sevoflurane is a volatile anesthetic that can tolerate inhalation induction and is widely used for inducing anesthesia due to its pleasant odor. As a drug that has been on the market for nearly 30 years, the vast majority of adverse reactions have been documented. This study aims to improve the adverse reactions related to Sevoflurane through the mining, organizing and analysis of Food and Drug Administration Adverse Event Reporting System database data. We collected, organized, and analyzed reports from the first quarter of 2004 to the fourth quarter of 2022. We performed disproportionality analysis algorithms, including reporting odds ratio, the proportional reporting ratio values, to quantify the signal values of different adverse events (AEs). A total of 1126 AEs and 27 system organ classes were identified by performing statistics analysis system software. By combining algorithm calculations, we create a forest map of the top 30 AEs of the reporting odds ratio signal. Based on the reviewing relevant literature, we found that the vast majority of AEs have been reported in relevant studies. However, there is currently no study revealing the correlation between atrial fibrillation and Sevoflurane, which means that atrial fibrillation may be an unreported AE of Sevoflurane. In the present study, we found that atrial fibrillation may be a new adverse reaction of Sevoflurane through the Food and Drug Administration Adverse Event Reporting System database, which can function as a novel guideline to guide us in the more standardized use of Sevoflurane in clinical practice.
七氟醚是一种挥发性麻醉剂，可耐受吸入诱导，因其气味宜人而被广泛用于诱导麻醉。作为一种已经上市近 30 年的药物，其绝大多数不良反应均有记录。本研究旨在通过挖掘、整理和分析美国食品药品监督管理局不良事件报告系统数据库中的数据，提高与七氟醚相关的不良反应。我们收集、整理和分析了 2004 年第一季度至 2022 年第四季度的报告。我们采用了比例失衡分析算法，包括报告比值比和比例报告比值值，以量化不同不良反应（AE）的信号值。通过统计分析系统软件进行分析，共确定了 1126 例 AE 和 27 个系统器官类别。通过结合算法计算，我们创建了报告比值比信号的前 30 个 AE 的森林图。通过回顾相关文献，我们发现大多数 AE 已经在相关研究中报道过。然而，目前尚无研究表明房颤与七氟醚之间存在相关性，这意味着房颤可能是七氟醚未报告的 AE。在本研究中，我们通过美国食品药品监督管理局不良事件报告系统数据库发现，房颤可能是七氟醚的一种新的不良反应，这可以作为指导我们在临床实践中更规范使用七氟醚的新指南。
