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The Incidence, Classification, and Management of Acute Adverse Reactions to the Low-Osmolar Iodinated Contrast Media Isovue and Ultravist in Contrast-Enhanced Computed Tomography Scanning

View Article: PubMed Central - PubMed

ABSTRACT

Some epidemiologic surveillance studies have recorded adverse drug reactions to radiocontrast agents. We aimed to investigate the incidence and management of acute adverse reactions (AARs) to Ultravist-370 and Isovue-370 in patients who underwent contrast-enhanced computed tomography (CT) scanning.

Data from 137,473 patients were analyzed. They had undergone enhanced CT scanning with intravenous injection of Ultravist-370 or Isovue-370 during the period of January 1, 2006 to December 31, 2012 in our hospital. We investigated and classified AARs according to the American College of Radiology and the Chinese Society of Radiology (CSR) guidelines for iodinated contrast media. We analyzed risk factors for AARs and compared the AARs induced by Ultravist-370 and Isovue-370.

Four hundred and twenty-eight (0.31%) patients experienced AARs, which included 330 (0.24%) patients with mild AARs, 82 (0.06%) patients with moderate AARs, and 16 (0.01%) patients with severe AARs (including 3 cases of cardiac arrest and one case of death). The incidence of AARs was higher with Ultravist-370 than with Isovue-370 (0.38% vs 0.24%, P < 0.001), but only for mild AARs (0.32% vs 0.16%, P < 0.001). Analyses on risk factors indicated that female patients (n = 221, 0.43%, P < 0.001), emergency patients (n = 11, 0.51%, P < 0.001), elderly patients aged 50 to 60 years (n = 135, 0.43%, P < 0.001), and patients who underwent coronary computed tomography angiography (CTA) (n = 55, 0.51%, P < 0.001) had a higher risk of AARs. Cutaneous manifestations (50.52%)—especially rash (59.74%)—were the most frequent mild AARs. Cardiovascular manifestations accounted for most moderate and severe AARs (62.91% and 48.28%, respectively). After proper management, the symptoms and signs of 96.5% of the AARs resolved within 24 hours without sequelae.

Ultravist-370 and Isovue-370 are safe for patients undergoing enhanced CT scanning. The incidence of AARs is higher with Ultravist-370 than with Isovue-370, but this difference is limited only to the mild AARs. The incidence of AARs could be affected by multiple factors.

No MeSH data available.


Related in: MedlinePlus

Comparison of incidence of AARs between Ultravist-370 and Isovue-370. A, Overall incidence (P < 0.001); B, Incidence of mild AARs (P < 0.001); C, Incidence of moderate AARs (P = 0.152); D, Incidence of severe AARs (P = 0.584). AARs = acute adverse reactions.
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Figure 4: Comparison of incidence of AARs between Ultravist-370 and Isovue-370. A, Overall incidence (P < 0.001); B, Incidence of mild AARs (P < 0.001); C, Incidence of moderate AARs (P = 0.152); D, Incidence of severe AARs (P = 0.584). AARs = acute adverse reactions.

Mentions: The overall incidence of AARs was 0.31% (n = 428). There were 330 (0.24%) mild AARs, 82 (0.06%) moderate AARs, 16 (0.01%) severe AARs (including 3 cases of cardiac arrest and 1 case of death). The mild, moderate, and severe AARs accounted for 77.1%, 19.2%, and 3.7% of all AARs, respectively. The overall incidence of AARs was higher with Ultravist-370 than with Isovue-370 (0.38% vs 0.24%, P < 0.001). We observed a statistical significance between Ultravist-370 and Isovue-370 only for mild AARs (0.32% vs 0.16%, P < 0.001), but not for moderate AARs (0.07% vs 0.05%, P = 0.152) or severe AARs (0.01% vs 0.01%, P = 0.584) (Figure 1). Analyses of the risk factors revealed that female patients (n = 221, 0.41%) had a higher incidence of AARs than male patients (n = 207, 0.25%), and the difference was statistically significant (P < 0.001) (Table 2). For patients in the different age groups, the incidence of AARs was highest in the age group of 50 to 60 years (0.43%, n = 135, P < 0.001), followed by the age group of 20 to 30 years (0.39%, n = 22, P < 0.001), whereas patients >80 years had the lowest incidence (n = 8, 0.11%, P < 0.001) (Table 2 and Figure 2). The incidence of AARs was 0.51% (n = 11), 0.42% (n = 299), and 0.18% (n = 118) for emergency patients, outpatients, and inpatients, respectively (Table 2 and Figure 3). The incidence of AARs was 0.51% (n = 55), 0.27% (n = 20), 0.18% (n = 11), and 0.30% (n = 342) for patients who underwent coronary computed tomography angiography (CTA), head and neck CTA, aortic CTA, and other enhanced CT examinations, respectively. The differences reached statistical significance (P < 0.001) (Table 2 and Figure 4).


The Incidence, Classification, and Management of Acute Adverse Reactions to the Low-Osmolar Iodinated Contrast Media Isovue and Ultravist in Contrast-Enhanced Computed Tomography Scanning
Comparison of incidence of AARs between Ultravist-370 and Isovue-370. A, Overall incidence (P < 0.001); B, Incidence of mild AARs (P < 0.001); C, Incidence of moderate AARs (P = 0.152); D, Incidence of severe AARs (P = 0.584). AARs = acute adverse reactions.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4998399&req=5

Figure 4: Comparison of incidence of AARs between Ultravist-370 and Isovue-370. A, Overall incidence (P < 0.001); B, Incidence of mild AARs (P < 0.001); C, Incidence of moderate AARs (P = 0.152); D, Incidence of severe AARs (P = 0.584). AARs = acute adverse reactions.
Mentions: The overall incidence of AARs was 0.31% (n = 428). There were 330 (0.24%) mild AARs, 82 (0.06%) moderate AARs, 16 (0.01%) severe AARs (including 3 cases of cardiac arrest and 1 case of death). The mild, moderate, and severe AARs accounted for 77.1%, 19.2%, and 3.7% of all AARs, respectively. The overall incidence of AARs was higher with Ultravist-370 than with Isovue-370 (0.38% vs 0.24%, P < 0.001). We observed a statistical significance between Ultravist-370 and Isovue-370 only for mild AARs (0.32% vs 0.16%, P < 0.001), but not for moderate AARs (0.07% vs 0.05%, P = 0.152) or severe AARs (0.01% vs 0.01%, P = 0.584) (Figure 1). Analyses of the risk factors revealed that female patients (n = 221, 0.41%) had a higher incidence of AARs than male patients (n = 207, 0.25%), and the difference was statistically significant (P < 0.001) (Table 2). For patients in the different age groups, the incidence of AARs was highest in the age group of 50 to 60 years (0.43%, n = 135, P < 0.001), followed by the age group of 20 to 30 years (0.39%, n = 22, P < 0.001), whereas patients >80 years had the lowest incidence (n = 8, 0.11%, P < 0.001) (Table 2 and Figure 2). The incidence of AARs was 0.51% (n = 11), 0.42% (n = 299), and 0.18% (n = 118) for emergency patients, outpatients, and inpatients, respectively (Table 2 and Figure 3). The incidence of AARs was 0.51% (n = 55), 0.27% (n = 20), 0.18% (n = 11), and 0.30% (n = 342) for patients who underwent coronary computed tomography angiography (CTA), head and neck CTA, aortic CTA, and other enhanced CT examinations, respectively. The differences reached statistical significance (P < 0.001) (Table 2 and Figure 4).

View Article: PubMed Central - PubMed

ABSTRACT

Some epidemiologic surveillance studies have recorded adverse drug reactions to radiocontrast agents. We aimed to investigate the incidence and management of acute adverse reactions (AARs) to Ultravist-370 and Isovue-370 in patients who underwent contrast-enhanced computed tomography (CT) scanning.

Data from 137,473 patients were analyzed. They had undergone enhanced CT scanning with intravenous injection of Ultravist-370 or Isovue-370 during the period of January 1, 2006 to December 31, 2012 in our hospital. We investigated and classified AARs according to the American College of Radiology and the Chinese Society of Radiology (CSR) guidelines for iodinated contrast media. We analyzed risk factors for AARs and compared the AARs induced by Ultravist-370 and Isovue-370.

Four hundred and twenty-eight (0.31%) patients experienced AARs, which included 330 (0.24%) patients with mild AARs, 82 (0.06%) patients with moderate AARs, and 16 (0.01%) patients with severe AARs (including 3 cases of cardiac arrest and one case of death). The incidence of AARs was higher with Ultravist-370 than with Isovue-370 (0.38% vs 0.24%, P&#8202;&lt;&#8202;0.001), but only for mild AARs (0.32% vs 0.16%, P&#8202;&lt;&#8202;0.001). Analyses on risk factors indicated that female patients (n&#8202;=&#8202;221, 0.43%, P&#8202;&lt;&#8202;0.001), emergency patients (n&#8202;=&#8202;11, 0.51%, P&#8202;&lt;&#8202;0.001), elderly patients aged 50 to 60 years (n&#8202;=&#8202;135, 0.43%, P&#8202;&lt;&#8202;0.001), and patients who underwent coronary computed tomography angiography (CTA) (n&#8202;=&#8202;55, 0.51%, P&#8202;&lt;&#8202;0.001) had a higher risk of AARs. Cutaneous manifestations (50.52%)&mdash;especially rash (59.74%)&mdash;were the most frequent mild AARs. Cardiovascular manifestations accounted for most moderate and severe AARs (62.91% and 48.28%, respectively). After proper management, the symptoms and signs of 96.5% of the AARs resolved within 24 hours without sequelae.

Ultravist-370 and Isovue-370 are safe for patients undergoing enhanced CT scanning. The incidence of AARs is higher with Ultravist-370 than with Isovue-370, but this difference is limited only to the mild AARs. The incidence of AARs could be affected by multiple factors.

No MeSH data available.


Related in: MedlinePlus