Clinical safety evaluation of contrast agents based on real‐world evidence

作者：Cheng Jiang, Junlian Li, Yaoqin Huang, Daiying Huang, Jingran Lin, Xin Jiang · 发表于：Journal of Clinical Pharmacy and Therapeutics · 年份：2021 · DOI：10.1111/jcpt.13485 · 被引用次数：8 · 研究领域：Acute Kidney Injury Research、Lanthanide and Transition Metal Complexes、Ultrasound and Hyperthermia Applications

WHAT IS KNOWN AND OBJECTIVE: This study was aimed at comparing the adverse drug reactions (ADRs) arising from the use of iodinated contrast medium (ICM) and gadolinium-based contrast media (GBCM), and to provide a basis for the clinical selection of contrast media. METHODS: Retrospective data for ADR cases occurring from the use of ICM or GBCM during enhanced scanning in computed tomography and magnetic resonance imaging were collected between June/2013 and May/2020 from Wenling Hospital of Traditional Chinese Medicine. Chi-square tests were performed based on the characteristics of patients and the classification of contrast medium. Bonferroni correction was applied to the statistical analyses with multiple comparisons of proportions. RESULTS: Among 27,328 patients who were subjected to enhanced CT scanning, 207 cases (0.76%) showed ICM-related ADRs. Among 16,381 patients who were subjected to enhanced MRI scanning, 25 cases (0.15%) showed ADRs related to GBCM. The incidence of ADR induced by GBCM was significantly lower than ICM-induced ADR (p < 0.01). There were no significant differences in the incidence among different types of ICM, including ioversol and iodixanol, as well as iodixanol from different manufacturers (p > 0.05). Interestingly, the ADR incidence of ICM seemed to be associated with gender, with a significantly higher incidence in females than in male patients, and it was also associated with the age, with a lower occurrence in older (>44 years) compared to y...