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2 results on '"Italian Society for Ultrasound in Medicine and Biology (SIUMB) Study Group on Ultrasound Contrast Agents."'

1. The safety of Sonovue® in abdominal applications: Retrospective analysis of 23188 investigations

Author

Piscaglia, Fabio, Bolondi, Luigi, and Italian Society for Ultrasound in Medicine and Biology (SIUMB) Study Group on Ultrasound Contrast Agents

Subjects
*ULTRASONIC imaging, *MAGNETIC fields, *CLINICAL medicine, *MAGNETIC resonance
Abstract

Abstract: 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. (E-mail: Piscagl@med.unibo.it) [Copyright &y& Elsevier]

Published
2006
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2. The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations

Author

Piscaglia, F, Bolondi, L, Italian Society for Ultrasound in Medicine, Aiani, Biology Study Group on Ultrasound Contrast Agents 1 L., Luigi Angeli, M., Arienti, V., Barozzi, L., Basilico, R., Bertolotto, M., Biasini, E., Busilacchi, P., Calliada, F., Caremani, * M., Caturelli, E., Celli, N., Colecchia, A., Cova, L., Assunta Cova, M., Crocetti, L., de Sio, I., Drudi, Francesco Maria, Ferraioli, G., Filice, C., Fornari, F., Gaiani, S., Giangregorio, F., Giorgio, A., Ierace, T., Lencioni, R., Livraghi, T., Magnolfi, F., Martegani, A., Meloni, F., Menozzi, G., Pelosi, G., Pompili, M., Riccardi, L., Ricci, P., Rubaltelli, L., Sacerdoti, D., Serafini, G., Serra, C., Solbiati, L., Tacconi, D., Valentino, M., Vidili, G., Vitali, F., Piscaglia F., Bolondi L., and Italian Society for Ultrasound in Medicine and Biology (SIUMB) Study Group on Ultrasound Contrast Agents.

Subjects
medicine.medical_specialty, Acoustics and Ultrasonics, Sulfur Hexafluoride, Biophysics, Contrast Media, Abdomen, medicine, Retrospective analysis, Adverse Drug Reaction Reporting Systems, Humans, Radiology, Nuclear Medicine and imaging, Adverse effect, Phospholipids, Retrospective Studies, Ultrasonography, Radiological and Ultrasound Technology, medicine.diagnostic_test, business.industry, Incidence (epidemiology), Magnetic resonance imaging, Retrospective cohort study, Safety profile, medicine.anatomical_structure, Liver, Abdominal examination, Radiology, business
Abstract

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.

Published
2006

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