Clinical safety evaluation of contrast agents based on real-world evidence.

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 younger patients. WHAT IS NEW AND CONCLUSION: With respect to ADR incidence, the safety profile of ICM of different types and different manufacturers was found to be similar in clinical use, warranting no need of specifically choosing imported or more expensive products. While choosing contrast medium type for clinical use, attention should be paid to certain populations, especially to younger and female patients when the patients are about to undergo a contrast-enhanced examination.