Abstract
Purpose: Although the number of patients undergoing contrast-enhanced ultrasound (CEUS) with perflubutane has increased continuously since its introduction, its safety and efficacy in multiple patients with various chronic and concomitant disease and from multiple institutions has remained unreported. We therefore carried out a drug-use results survey to assess the safety and efficacy of perflubutane in clinical practice. Subjects and Methods: Subjects were patients to whom perflubutane had been administered for ultrasound contrast imaging of focal hepatic lesions, for which perflubutane is indicated. The survey was conducted nationwide in an attempt to collect data from 3,000 subjects. Results and Discussion: We collected data from 3,655 subjects in 257 institutions. Adverse reactions occurred in 16 of the 3,418 subjects deemed eligible for safety evaluation, and the incidence of adverse reactions was 0.5%. However, none of adverse reactions were serious. Moreover, no concerns requiring special safety measures were identified. Among the 3,283 subjects eligible for efficacy evaluation, the efficacy in tests for all purposes for CEUS in vascular imaging, in post vascular imaging, and in overall efficacy was 92.5%, 93.2%, and 94.1%, respectively. Efficacy ranged between from 83.0% and 97.5% throughout, for all purposes and in each imaging, indicating that the efficacy in clinical practice had been demonstrated. Conclusion: CEUS with perflubutane has the potential to become a safe modality for both diagnosis and therapy of hepatic focal lesions, including such uses as US-guided RFA and evaluation of therapeutic effects.
