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문제 정의
- Therefore, the objectives of this study were to identify the risk factors for adverse reactions in Korean patients who were administered iodinated contrast media during CT scans through a retrospective prescription analysis and electronic medical record investigation and to analyze the frequency of adverse reaction occurrences.
가설 설정
- 2) It was performed in a single medical center on a relatively small number of patients.
제안 방법
- Frequency analyses and basic statistical analyses were performed to analyze the general characteristics of the subjects. For both the AR group and the control group, continuous variables, including age and dose, were presented as the mean and standard deviation (SD), and t-tests were performed.
- The characteristics of the subjects who underwent kidney CT scans were exactly the same as those who were administered the contrast medium Iohexol and they were therefore excluded from multivariate logistic regression analysis.
- The subjects who experienced contrast media-induced adverse reactions were classified into the adverse reaction (AR) group. The control group was populated by selecting 4 times as many subjects as the number of patients in the AR group out of a group of patients without adverse reactions using simple random sampling. The electronic medical records of the patients of the AR and control groups were examined to investigate previous contrast media administration, allergy history, comorbidity, and contrast media-induced adverse reactions, which ultimately enabled the identification of risk factors for contrast media-induced adverse reactions and the analysis of the frequency of adverse reaction occurrences.
- The control group was populated by selecting 4 times as many subjects as the number of patients in the AR group out of a group of patients without adverse reactions using simple random sampling. The electronic medical records of the patients of the AR and control groups were examined to investigate previous contrast media administration, allergy history, comorbidity, and contrast media-induced adverse reactions, which ultimately enabled the identification of risk factors for contrast media-induced adverse reactions and the analysis of the frequency of adverse reaction occurrences.
- The other categorical variables were subjected to cross tabulation analyses with Chi-square tests and Fisher's exact tests.
대상 데이터
- Mary’s Hospital IRB Committee. Adult patients aged 18 years or older who were administered iodinated contrast media during CT scans between January 1 and December 31, 2012, were included. Patients were excluded if they had no follow-up or lacked electronic medical records.
- In this study, patients were administered various types of iodinated contrast media, including iohexol, iomeprol, ioversol, iopromide, and iodixanol. Iohexol, iomeprol, ioversol, and iopromide are nonionic, monomeric, low osmolar contrast media, while iodixanol is a nonionic, dimeric, iso-osmolar contrast medium.
- Of the 17,408 subjects who underwent CT scans with iodinated contrast media during the study period, adverse reactions were reported in 103 subjects (0.6%).
- During the study period, the total number of subjects who were administered iodinated contrast media while undergoing CT scans was 17,408. The AR group, which included individuals who experienced contrast media-induced adverse reactions, included 103 subjects, and the control group, which was designed to have 4 times as many subjects as the AR group, included 412 subjects.
- This study evaluated patients who were administered iodinated contrast media during CT scans at Yeoeuido St. Mary’s Hospital, a tertiary teaching hospital in Seoul, Korea, from January to December 2012.
데이터처리
- Frequency analyses and basic statistical analyses were performed to analyze the general characteristics of the subjects. For both the AR group and the control group, continuous variables, including age and dose, were presented as the mean and standard deviation (SD), and t-tests were performed. The other categorical variables were subjected to cross tabulation analyses with Chi-square tests and Fisher's exact tests.
성능/효과
- Among the included patient factors, females [odds ratio (OR): 2.091; 95% confidence interval (CI): 1.345-3.252], allergy history (OR: 2.707; 95% CI: 1.274-5.752), and comorbid asthma (OR: 5.203; 95% CI: 1.372-19.735) were confirmed as significant variables that increase the risk of contrast media-induced adverse reactions.
- In the results, immediate adverse reactions that occurred within 1 hour of contrast media administration were identified in 96 subjects (93.2%), which accounts for the majority of the adverse reactions. Such results showing that most contrast media-induced adverse reactions are immediate adverse reactions are in agreement with previous studies.
- 0 g (mean ± SD). Regarding CT region, in cases where the same patient underwent CT scans of different regions, each region was calculated separately, and the results showed that the abdomen (pelvis) was the most commonly scanned region with 3,856 subjects (22.2%), followed by the chest with 3,416 subjects (19.6%), and the liver/spleen/pancreas with 3,199 subjects (18.4%) (Table 1).
- Regarding contrast media factors, using Iohexol as a contrast medium (OR: 11.995; 95% CI: 4.067-35.379) and scanning the kidney during CT (OR: 3.191; 95% CI: 1.307-7.795) were confirmed to be significant variables that increased the risk of adverse reactions, whereas scanning the abdomen (pelvis) during CT (OR: 0.447; 95% CI: 0.229-0.872) was confirmed as a significant variable that decreased the risk of adverse reactions.
- There was a statistically significant difference in the types of contrast media used between the AR group and the control group. The percentage of CT scans of the kidney was significantly higher in the AR group than in the control group, whereas the percentage of scans of the abdomen (pelvis) was significantly lower (Table 3).
- 193). The presence of an allergy history was associated with a 3.982-fold higher risk of adverse reactions compared to the absence of one (OR:3.982; 95% CI: 1.742-9.101), and the presence of asthma as comorbidity led to a 6.619-fold higher AR risk (OR: 6.619;95% CI: 1.377-31.826) (Table 4).
- This study found that female sex, the use of Iohexol as a contrast medium, an allergy history, and comorbid asthma were risk factors for contrast media-induced adverse reactions. For safe contrast media utilization, evaluations of whether an individual patient possesses risk factors for contrast mediainduced adverse reactions should be performed prior to contrast media administration.
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