Evaluation of Adverse Events and Imaging Quality in Contrast-Enhanced Abdominal CT Using Generic CT Contrast Developed in South Korea: A Multicenter Prospective Observational Study

Abstract

Purpose The purpose of this study is to evaluate the clinical safety and usefulness of the Prosure®300 in contrast-enhanced abdominal CT. Materials and Methods This prospective study was approved by our center's Institutional Review Board. This study included 727 patients in four hospitals who underwent contrast-enhanced abdominal CT using Prosure®300 from December 2010 to June 2011. Adverse events were classified into minor and major adverse events. Logistic regression analysis was used to evaluate the relationship between adverse events and patient gender, age, underlying disease, and amount of injected contrast agent. Two radiologists independently evaluated imaging quality as poor, insufficient, sufficient, good, or very good. Results One hundred seventy-six out of 727 patients complained of adverse events, but most of them were minor adverse events. Five patients complained of dyspnea and one patient had hoarseness, but recovered without treatment. The rate of adverse events was significantly higher in men (p = 0.011), and a greater amount of injected contrast agent was related to a higher rate of adverse events (p = 0.000). Imaging quality was evaluated as ‘good’ or ‘very good’ in all cases. Conclusion Prosure®300, a generic CT contrast agent developed in South Korea, can be used in contrast-enhanced abdominal CT.

Keywords

• ct
• iopromide
• nonionic contrast medium
• adverse drug events
• abdomen