PubMed · 8046482
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H N Wagner. 1994. Disease as dissonance.. https://pubmed.ncbi.nlm.nih.gov/8046482/
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OBJECTIVES: This systematic review and meta-analysis are aimed at evaluating the incidence of adverse drug reactions (ADRs) following administration of clinically approved ultrasound contrast agents (UCAs) in adults and children, to assess risks in patients with cardiovascular disease and in pregnancy, and to evaluate the effectiveness of emergency management of severe ADRs. MATERIALS AND METHODS: A PRISMA 2020 systematic review was conducted searching PubMed, Scopus, and Embase. Two reviewers independently screened, extracted data, and assessed quality. Incidence estimates were pooled when feasible, stratified by age group, contrast agent, and administration route. RESULTS: Seventy-four studies encompassing > 1 million adults and > 36,000 children were included, contributing multiple analytic cohorts to the quantitative synthesis. Severe acute ADRs were extremely rare (6 and 16 cases per 100,000 in adults and children, respectively) and absent following endocavitary administration in children. Non-severe acute ADRs occurred in 11 and 8 cases per 10,000 adults and children, respectively. Delayed reactions were very rare (< 1 case per million in adults). No significant safety differences emerged between UCA products. The incidence of ADRs in patients with cardiovascular disease was analogous to the general population. No ADRs were reported in pregnant women. Standard emergency management was effective in almost all serious cases, though rare fatalities occurred. CONCLUSION: UCAs show an excellent safety profile in adults and children, with very rare severe ADRs and few non-severe, typically self-limiting reactions. Strict adherence to recommended emergency management protocols mitigates the remaining risks, supporting safe use across a broad range of clinical indications. PROSPERO REGISTRATION: CRD42023432668. KEY POINTS: Question What is the incidence, type, and severity of acute and delayed ADRs associated with clinically approved UCAs across different patient populations? Findings Severe acute adverse reactions are very rare, and non-severe reactions are rare and self-limiting, with no significant safety differences between adults, children, or patients with cardiovascular disease. Clinical relevant UCAs show an excellent safety profile across populations. These findings support their safe clinical use as reliable alternatives to iodine-based and gadolinium-based contrast agents in routine diagnostic imaging.
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OBJECTIVE: The purpose of this study was to compare 2 film systems and several digital intraoral systems with regard to visual image quality through use of a test phantom developed for this purpose. STUDY DESIGN: The detectors used for digital imaging were as follows: Computed Dental Radiography (CDR), Digora, Dixel, and Sens-A-Ray without scintillator layer. Two types of digital images were prepared for the observer performance test: one with original gray scales and another with contrast enhancement. Images with and without enhancement from the 4 systems were displayed to 7 observers. The change in the average number of perceptible holes was plotted against exposure, and modified perceptibility curves were created and compared with curves for the film systems. The exposure level at which the maximum number of holes was perceived was defined to be optimum. The optimum exposure levels were determined for each digital system and compared with that of the film systems. At the optimum exposure, the average maximum numbers of perceptible holes in each digital system with and without contrast enhancement were compared with the maximum numbers for the film systems. The minimum exposure levels were determined to be those at which the number of perceptible holes exceeded the number for film, and the possibility of exposure reduction was evaluated. RESULTS: All digital systems except the Digora system showed lower optimum exposures than E-speed film. In all digital images without enhancement, however, the maximum number of perceptible holes was significantly lower than that for the film systems at that exposure. With contrast enhancement, all digital systems except the Sens-A-Ray system showed visibility superior to that of the film systems. With the CDR, Digora, and Dixel systems, exposures could be further reduced by a considerable amount, with greater retention of information than was associated with film. CONCLUSIONS: Our results strongly suggest that digital systems, if properly used, can exceed film systems in the detection of small mass changes.