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Kim, Jung, Lee, Hwang, Lim, Park, Park, and Rha: 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
Abdominal Radiology
Original Article

Journal of the Korean Society of Radiology 2017; 76(2): 83-90.

Published online: 31 January 2017

DOI: https://doi.org/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

You Sung Kim, MD1, Seung Eun Jung, MD2, Soo Rim Lee, MD3, Seong Su Hwang, MD4, Yeon Soo Lim, MD5, Jeongmi Park, MD6, Michael Yong Park, MD2, Sung Eun Rha, MD2

1Department of Radiology, Ilsan Paik Hospital, College of Medicine, Inje University, Goyang, Korea.

2Department of Radiology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.

3Department of Radiology, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea.

4Department of Radiology, St. Vincent Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.

5Department of Radiology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Korea.

6Department of Radiology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.

Corresponding author: Seung Eun Jung, MD. Department of Radiology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea. Tel. 82-2-2258-1428, Fax. 82-2-599-6771, sejung@catholic.ac.kr

Received 30 March 2016       Revised 29 June 2016       Accepted 12 July 2016

Copyright © 2017 The Korean Society of Radiology

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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

Figures and Tables

Fig. 1

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

jksr-76-83-g001
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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Table 1

Incidences of Adverse Events (AEs)

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Type of AEs Number (%)
Minor
 Febrile sensation 115 (15.82)
 Nausea 33 (4.54)
 Dizziness 19 (2.61)
 Itching sensation 17 (2.34)
 Urticaria 16 (2.20)
 Vomiting 4 (0.55)
 Metallic taste 2 (0.28)
 Edema 1 (0.14)
 Sneezing 1 (0.14)
 Chilling sensation 1 (0.14)
 Pain 1 (0.14)
 Stuffiness 1 (0.14)
 Abdominal distension 1 (0.14)
Major 5 (0.69)
 Dyspnea 1 (0.14)
 Hoarseness
Total 218
Table 2

Complication Rates in Patients Trouped According to Each Variables and the Result of Logistic Regression Analysis

jksr-76-83-i002
Variable (Total Number of the Patients) Number of the Patients Who Had AEs (%) p-Value ExpB*
Gender 0.011 0.011
 Male (n = 442) 98 (22.2)
 Female (n = 285) 78 (27.4)
Age in years 0.105 0.105
 ≤ 54.7 (n = 364) 93 (25.6)
 54.7 < (n = 363) 83 (22.9)
Underlying disease† 0.668 0.668
 Yes (n = 289) 64 (22.2)
 No (n = 438) 112 (25.6)
Volume of contrast media 0.000 0.000
 ≤ 116.8 (n = 411) 93 (22.6)
 116.8 < (n = 316) 83 (26.3)

*ExpB is the change in the odds ratio associated with a 1 unit change in the predictor variable.

†Underlying disease including asthma, allergy of food or medicine, diabetes mellitus, hypertension, and cardiac disease.

AEs = adverse events

Acknowledgments

This study was supported by a grant from the LG Life Sciences Ltd., Seoul, Korea.

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