Safety of Perflutren Ultrasound Contrast Agents: A Disproportionality Analysis of the US FAERS Database

Hauben, Manfred; Hung, Eric; Hanretta, Kelly C.; Bangalore, Sripal; Snow, Vincenza

doi:10.1007/s40264-015-0332-6

Cited by 6 publications

(3 citation statements)

References 48 publications

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“…MB cavitation is generally harmless when excited with low energy US pulses. Indeed, MBs have been used clinically for decades in diagnostic applications, and their safety has been clearly established in this context [ 59 ]. When stimulated by higher amplitudes and/or longer US pressure wave durations, MBs undergo stronger oscillations that locally amplify the thermal and mechanical effects of the US.…”

Section: Ultrasound and Microbubble-induced Atp Release For Enhancing Cancer Immunotherapymentioning

confidence: 99%

Lytic Release of Cellular ATP: Physiological Relevance and Therapeutic Applications

Grygorczyk

Boudreault

Ponomarchuk

et al. 2021

Life

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The lytic release of ATP due to cell and tissue injury constitutes an important source of extracellular nucleotides and may have physiological and pathophysiological roles by triggering purinergic signalling pathways. In the lungs, extracellular ATP can have protective effects by stimulating surfactant and mucus secretion. However, excessive extracellular ATP levels, such as observed in ventilator-induced lung injury, act as a danger-associated signal that activates NLRP3 inflammasome contributing to lung damage. Here, we discuss examples of lytic release that we have identified in our studies using real-time luciferin-luciferase luminescence imaging of extracellular ATP. In alveolar A549 cells, hypotonic shock-induced ATP release shows rapid lytic and slow-rising non-lytic components. Lytic release originates from the lysis of single fragile cells that could be seen as distinct spikes of ATP-dependent luminescence, but under physiological conditions, its contribution is minimal <1% of total release. By contrast, ATP release from red blood cells results primarily from hemolysis, a physiological mechanism contributing to the regulation of local blood flow in response to tissue hypoxia, mechanical stimulation and temperature changes. Lytic release of cellular ATP may have therapeutic applications, as exemplified by the use of ultrasound and microbubble-stimulated release for enhancing cancer immunotherapy in vivo.

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Section: Ultrasound and Microbubble-induced Atp Release For Enhancing Cancer Immunotherapymentioning

confidence: 99%

Lytic Release of Cellular ATP: Physiological Relevance and Therapeutic Applications

Grygorczyk

Boudreault

Ponomarchuk

et al. 2021

Life

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“…This aspect raises ethical issues: on one hand, the researcher may be more prone toward an alarming interpretation of the findings to increase the impact of the publication. On the other hand, when broadly looking at the published literature in the past 5 years, only a minority of industry-sponsored studies provided "negative findings," that is, the lack of statistically significant DAs [17,18].…”

Section: There Is Increasing Availability Of Publicly Accessible Srssmentioning

confidence: 99%

Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety

Raschi¹,

Moretti²,

Salvo³

et al. 2019

Pharmacovigilance

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This chapter aims to describe current and emerging roles of spontaneous reporting systems (SRSs) for assessing and monitoring drug safety. Moreover, it offers a perspective on the near future, which entails the so-called era of Big Data, keeping in mind both regulator and researcher viewpoints. After a panorama on key data sources and analyses of post-marketing data of adverse drug reactions, a critical appraisal of methodological issues and debated future applications of SRSs will be presented, including the exploitation and challenges in evidence integration (i.e., merging and combining heterogeneous sources of data into a unique indicator of risk) and patient's reporting via social media. Finally, a call for a responsible use of these studies is offered, with a proposal on a set of minimum requirements to assess the quality of disproportionality analysis in terms of study conception, performing and reporting.

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“…As a result, UCAs are not nephrotoxic and have not shown any delayed or long-term adverse effects associated with their use. 8,9…”

mentioning

confidence: 99%

Contrast-Enhanced Ultrasound: A Technology Primer

Baun¹

2017

Journal of Diagnostic Medical Sonography

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Background Contrast imaging, in general, involves the use of an agent to enhance the contrast of structures or fluids in the human body. A variety of contrast agents have been employed in medical imaging over many decades, beginning with the use of air and barium in the early days and evolving into the complex pharmacologic agents currently in use in computed tomography (CT), magnetic resonance, positron emission tomography, and nuclear medicine imaging modalities. Through various physical interactions between the agent and the energy used by the modality creating the image, dissimilarities in tissue types and boundaries are accentuated, which permits better differentiation between them. Ultrasound Contrast Agents Ultrasound contrast agents (UCAs) consist of gaseous microbubbles suspended in an aqueous solution that is injected into the human venous vascular system. They are composed of an inert inner gas bubble surrounded by a stabilizing outer shell (Figure 1). Different UCA manufacturers use various gas/shell combinations. As the microbubbles are "blood pool" agents, they remain intravascular at all times and do not permeate into adjacent tissues. As such, they act effectively as red blood cell tracers. The great acoustic mismatch between gas and surrounding blood results in dramatic and predictable physical responses when the microbubbles are exposed to an acoustic energy field. Reflection, backscatter and nonlinear harmonic responses create a returning acoustic data set that can be processed in ways that permit the 715221J DMXXX10.

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Safety of Perflutren Ultrasound Contrast Agents: A Disproportionality Analysis of the US FAERS Database

Cited by 6 publications

References 48 publications

Lytic Release of Cellular ATP: Physiological Relevance and Therapeutic Applications

Lytic Release of Cellular ATP: Physiological Relevance and Therapeutic Applications

Evolving Roles of Spontaneous Reporting Systems to Assess and Monitor Drug Safety

Contrast-Enhanced Ultrasound: A Technology Primer

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