The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations.
By F. Piscaglia, L. Bolondi. Ultrasound in Medicine and Biology, 2006
780 citations recorded by the source corpus.
The aim of the present retrospective study was to assess the incidence of adverse events (AE) of a second-generation ultrasound contrast agent in real clinical practice. A total of 28 Italian Centres provided data on the postmarketing use of SonoVue (Bracco Spa, Milan, Italy) in abdominal examination performed between December 2001 and December 2004. A total of 23 188 investigations were reported. No fatal event occurred. AEs were reported in 29 cases, of which only two were graded as serious; the rest, 27, were nonserious (23 mild, three moderate and one severe). The overall reporting rate of serious AE was 0.0086%. Overall, only four AEs required treatment (two serious, two nonserious including one moderate and one severe AEs). In conclusion, the present large-scale retrospective analysis showed that SonoVue has a good safety profile in abdominal applications, with an AE reporting rate lower than or similar to that reported for radiologic and magnetic resonance contrast agents.
Subfields: Biomedical Engineering, Nephrology, Surgery
View Paper: https://www.semanticscholar.org/paper/7c033f413d387dff1cb0bd6d18bbd70e04d1c794
How researchers see this paper
The researchers whose trusted networks rank it highest, strongest advocate first. Every researcher gets a different order.
- Luigi Solbiati
- P. Sidhu
- B. Choi
- V. Cantisani
- M. Chammas
- J. Fowlkes
- E. Bartels
- M. Radzina
Citations in the corpus
- The EFSUMB Guidelines and Recommendations for the Clinical Practice of Contrast-Enhanced Ultrasound (CEUS) in Non-Hepatic Applications: Update 2017 (Long Version) (2018, positive): “UCAs are administered safely in various applications with minimal risk to patients [4, 17 – 20].”
- Guidelines and good clinical practice recommendations for Contrast Enhanced Ultrasound (CEUS) in the liver - update 2012: A WFUMB-EFSUMB initiative in cooperation with representatives of AFSUMB, AIUM, ASUM, FLAUS and ICUS. (2013, background): “Life-threatening anaphy-lactoid reactions in abdominal applications have been reported with a rate of 0.001%, with no deaths in a series of >23000 patients [113].”