J Korean Soc Radiol.  2017 Feb;76(2):83-90. 10.3348/jksr.2017.76.2.83.

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

• Kim YS
• Jung SE
• Lee SR
• Hwang SS
• Lim YS
• Park J
• Park MY
• Rha SE

• KMID: 2367854
• DOI: http://doi.org/10.3348/jksr.2017.76.2.83

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.

MeSH Terms

Abdomen
Drug-Related Side Effects and Adverse Reactions
Dyspnea
Ethics Committees, Research
Hoarseness
Humans
Korea*
Logistic Models
Male
Observational Study*
Prospective Studies*
Tomography, X-Ray Computed*

Figure

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  Fig. 1 Molecular structure of iopromide. There are 4 of hydroxyl groups, which confer hydrophilicity.

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  Fig. 2 Axial scan of the arterial phase (A, B) of an abdominal CT scan performed with Prosure®300. The overall image quality and enhancement of the superior mesenteric artery, liver, kidneys, and pancreas in (A) were good. Decreased image quality and enhancement of liver, kidneys and pancreas in (B) are present due to a motion artifact. The image quality of (A) was evaluated as ‘very good,’ while that of (B) was evaluated as ‘good.’

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