约迪克桑醇的不良影响:使用FAERS数据库信号分析的回顾性安全研究
Yingwei Chang1, Lijun Yao2, Haiyan Zhang1
1Department of Radiology, Affiliated Hospital of Chengde Medical University, Chengde, China.
Medicine
|December 10, 2025
概括
这项研究分析了2212份约迪克桑醇不良事件报告,确定已知的风险和新的安全信号. 它强调了需要加强对对比剂安全性的警的特定种群和程序.
科学领域:
- 药物监督 药物监督 药物监督
- 医疗成像医学成像
- 药品安全 药品安全
背景情况:
- 二醇是医学成像中广泛使用的对比剂.
- 了解其安全概况对于临床实践和患者的结果至关重要.
- 之前的研究表明,与二醇相关的潜在不良事件.
研究的目的:
- 通过使用大规模的不良事件数据库,全面评估二醇的安全性.
- 为了识别和描述与二醇相关的不良事件信号.
- 为了比较约迪克桑醇与其他对比剂,如IOHEXOL和IOPAMIDOL的安全性.
主要方法:
- 食品和药物管理局 (FDA) 的不良事件报告系统数据库 (2004-2024) 的回顾性分析.
- 不成比例分析包括报告几率比率,比例报告比率,信息组件和经验贝叶斯几何平均值用于检测不良事件信号.
- 使用后勤回归来确定严重皮肤反应的危险因素.
主要成果:
- 对2212份二醇不良事件报告的分析显示,这种趋势正在增加,在2014年达到顶峰.
- 皮肤/皮下组织疾病,一般疾病/注射部位疾病和呼吸系统疾病是最常见的器官系统类信号.
- 与IOHEXOL和IOPAMIDOL相比,Iodixanol显示出独特的高风险心血管信号,并且在特定人群 (低体重,肥胖,老年人) 中严重反应的发生率更高.
- 年龄较小 (≤44岁) 和计算机断层扫描和血管扫描等手术是严重皮肤反应的重要风险因素.
- 检测到59种以前未在标签上列出的新型首选术语信号.
结论:
- 这项药监监测研究证实了已知的丁醇风险,并确定了新的安全信号.
- 特定的群体和程序需要提高警,当使用iodixanol.
- 调查结果为临床实践和有关对比剂安全性的监管决策提供了信息.
更多相关视频
13:48Reduction of Radiation Exposure during Endovascular Treatment of Peripheral Arterial Disease Combining Fiber Optic RealShape Technology and Intravascular Ultrasound
Published on: April 21, 2023
1.9K
10:01Improvement of a Closed Chest Porcine Myocardial Infarction Model by Standardization of Tissue and Blood Sampling Procedures
Published on: March 12, 2018
11.2K
相关概念视频
01:18Effects of EDTA on End-Point Detection Methods
600
Different methods, such as visual observance of metal-ion indicators, spectroscopic techniques, and potentiometric methods, can determine the endpoint of an EDTA titration.
In the visual method, metal-ion indicators (metallochromic dyes), which have distinct colors in their free and complex forms, are added to the mixture to signal the titration's end point. They form stable complexes with metal ions, but these complexes are weaker than the corresponding metal–EDTA complexes. As a...
In the visual method, metal-ion indicators (metallochromic dyes), which have distinct colors in their free and complex forms, are added to the mixture to signal the titration's end point. They form stable complexes with metal ions, but these complexes are weaker than the corresponding metal–EDTA complexes. As a...
600
01:19Pharmacovigilance
1.6K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.6K
01:17Imaging Studies for Cardiovascular System I:Echocardiography
702
Cardiac imaging studies encompass a wide range of noninvasive and minimally invasive techniques designed to visualize the heart's structure and function in detail. One such technique is echocardiography, which uses high-frequency ultrasound waves to produce detailed images of the heart, known as echocardiograms.
Indications: Echocardiography is utilized to diagnose heart failure, valve disorders, and myocardial infarction. It also assesses cardiac structures' size, shape, and motion,...
Indications: Echocardiography is utilized to diagnose heart failure, valve disorders, and myocardial infarction. It also assesses cardiac structures' size, shape, and motion,...
702