Adverse reactions to contrast media: related to medium or procedure? Observations on a case.
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Adult↗
Biomedical subjects
E Andrew
Publications and source records attributed to E Andrew.
Pharmacokinetics of iopentol in healthy volunteers.
Iopentol is a new non-ionic contrast medium. In order to study the pharmacokinetic properties, iopentol 350 mg I/ml was administered intravenously to healthy male volunteers at 3 dose levels (0.3, 0.6 and 1.2 g I/kg body weight). To evaluate renal excretion all subjects were given chromium-51-ethylenediaminetetraacetic acid (51Cr-EDTA) additionally to iopentol. The highest dose level group also received saline and 51Cr-EDTA about 3 weeks prior to iopentol. Serum, urine and faeces were sampled at different time intervals. Unmetabolized iopentol was excreted almost entirely in urine during the first 24 hours by means of glomerular filtration. A small fraction (2%) of the dose was excreted in faeces. No dose dependent pharmacokinetics was observed up to doses of 1.2 g I/kg body weight. The pharmacokinetic properties of iopentol make it a well suited contrast medium for vascular use.
Adult↗
Effect of iopentol on coagulation and platelet function in vitro and in vivo.
The effect on hemostatic parameters of two non-ionic contrast media, iopentol and iohexol in concentrations of 350 mg I/ml, were tested in vitro. The new medium iopentol had similar effects to those of iohexol, both with respect to the intrinsic coagulation system and platelet aggregation. As part of a human pharmacologic study the effects of iopentol on hemostatic parameters were tested in 8 volunteers in vivo. Iopentol induced a slightly decreased coagulability and aggregability in venous blood. It was concluded that the effects were of very little consequence for hemostasis as a whole.
Blood Coagulation↗
Autoimmunity in rheumatoid arthritis. An approach via a study of B lymphocytes.
In this article the relationship between the cellular elements of the immune response and inflammation are examined with reference to the B lymphocyte repertoire. Evidence is presented that, in addition to an environment in the joint that favors localization and activation of auto-reactive B lymphocytes, the circulating B lymphocyte pool in rheumatoid arthritis is abnormally enriched in cells that bear a receptor for mouse erythrocytes and possess CD5 antigen. B lymphocytes with these novel phenotypic markers secrete autoantibodies and are found in abundance in fetal lymphoid tissues and cord blood; analogous cells in the mouse belong to a distinct lineage and are implicated in allotype- and idiotype-restricted interactions. It is postulated that a subset of B lymphocytes is of primary importance in the etiopathogenesis of rheumatoid disease.
Arthritis, Rheumatoid↗
[Toxicologic experiments with drugs. Clinical relevance].
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Animals↗
Pharmacist involvement in Norwegian clinical drug trials: a questionnaire study.
In order to survey the involvement of pharmacists in clinical drug trials (CDTs) in Norway, a questionnaire was submitted to all community pharmacies (288), pharmacy departments in hospitals (98), and pharmaceutical companies (52). The response rate was 81, 73, and 64 percent, respectively. Community pharmacies had minimal involvement, while 34 percent of the pharmacy departments had taken part in one or more CDTs annually 1980-1982. During the same three-year period, 393 trials had been started by the responding companies. Within the pharmaceutical industry 41 percent of the CDT staff were pharmacists. Pharmacists in 48 percent of community pharmacies and 96 percent of pharmacy departments in hospitals considered CDTs a pharmaceutical task. However, none of the community pharmacists and less than half of the hospital pharmacists said they had knowledge of CDT methodology. We recommend that pharmacists should be more extensively engaged in CDTs. Their participation should not be limited to traditional pharmaceutical work, but should include CDT planning and monitoring. This in turn requires education in CDT methodology, which should be included in the compulsary pharmaceutical curriculum.
Attitude of Health Personnel↗
Damage of porcine aortic valve tissue caused by the surfactant sodiumdodecylsulphate.
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Aortic Valve↗
Intravenous digital subtraction angiography with iohexol (Omnipaque) and sodium meglumin diatrizoate (Urografin).
A randomized, double-blind crossover trial in intravenous digital subtraction angiography (DSA) (aorto-femoral or aorto-cervical) was performed in 38 patients with Omnipaque, 350 mg I/ml versus Urografin, 370 mg I/ml. The aim of the study was to compare subjective reactions, ECG, heart rate, blood pressure, image quality and disturbing artefacts. The median volume of contrast media given per patient was 165 ml, ranging from 85 to 250 ml. No serious complications occurred. Fewer and significantly (p less than 0.05) less intense reactions as sensations of heat and taste were experienced after Omnipaque. Significantly more patients preferred Omnipaque. The heart rate changed significantly more after Urografin than after Omnipaque. Urografin also caused a significantly greater but transient decrease in systolic and diastolic blood pressure. There was a tendency to better overall quality and less artefacts when using Omnipaque, but the difference between the two media was not statistically significant.
Aged↗
Omnipaque and Urografin in left ventriculography and coronary arteriography. A randomised, double blind study.
In order to compare tolerability and radiographic properties of Omnipaque (iohexol) 350 mg I/ml and Urografin (sodium meglumine diatrizoate) 76% (370 mg I/ml) in left ventriculography and coronary arteriography, a randomised, double-blind parallel study was conducted. ECG, heart rate, blood pressure, cardiac output, oxygen saturation, CK-MB, adverse reactions and opacification were recorded. Twenty-five patients received Omnipaque and 24 Urografin and all patients were included in the final material. Omnipaque was found to have less influence on haemodynamics than Urografin. Few adverse reactions were encountered in the entire study, but fewer after injections of Omnipaque than after Urografin. Equally good opacification was demonstrated for both media. Omnipaque was found well suited for cardioangiography and superior to standard ionic media.
Adult↗
Intravascular studies with iohexol (Omnipaque). Results from the first 49 clinical trials.
In order to assess the vascular clinical trial program of iohexol (Omnipaque) in Europe, the results from the first 49 vascular trials are collectively reported. The included iohexol material comprises 1742 patients. In 40 comparative trials, other contrast media like metrizamide (Amipaque), ioxaglate (Hexabrix) and various monomeric ionic media were administered in 1292 patients included in this analysis. No severe or unexpected adverse reactions related to iohexol were encountered. No clinically significant differences in radiographic image quality between the media were documented. The overall tolerability of iohexol was superior to that of monomeric ionic media and seemed to be as good as that of metrizamide.
Adolescent↗
Breathing resistance of dust respirators.
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Dust↗
A new, purified Dermatophagoides farinae allergen preparation. Evaluation with SPT and RAST techniques.
A purified, standardized and characterized allergen preparation of the house dust mite Dermatophagoides farinae (Df) was evaluated by skin prick test (SPT) and radioallergosorbent test (RAST) in 88 subjects. Skin reactions to the purified Df preparation and a corresponding crude Df preparation were compared. SPT was also performed with a crude Dermatophagoides pteronyssinus (Dpt) preparation to compare reactions obtained with the two mite preparations. By SPT the purified Df allergen preparation was representative of the crude Df preparation (r = 0.78) and the correlation between skin reactions to Df and Dpt was high (r = 0.78). The concordance between results obtained with RAST and SPT techniques with the purified Df preparation was high (84%). The purified D. farinae preparation was well tolerated and is well suited for SPT.
Allergens↗
Method for assessment of the reporting standard of clinical trials with roentgen contrast media.
A procedure for assessing the methodologic standard of the reports of contrast medium trials is described. Each report was assessed and scored on 11 different items important for evaluating the methodologic strength of a given trial. Although the method was rough, the first experiences indicate that reliable, comparative evaluations can be obtained. The method may be used for improving the reporting standard.
Clinical Trials as Topic↗
Evaluation of the vascular clinical trial program of metrizamide and iohexol.
The vascular clinical trial programs of the contrast media metrizamide (Amipaque) and iohexol ( Omnipaque ), organized by Nyegaard & Co. AS in Northern Europe were assessed and compared. The comparison comprised some selected characteristics of the programs, self-assessment by the investigators involved in both programs (questionnaire) and assessment of the standard of the trial reports (2 evaluators). It was found that Nyegaard clinical research staff spent in average 4 1/2 month for one iohexol trial compared with one month for one of metrizamide. The reason for this found to be a higher priority, increased regulatory requirements and a uniform data pool established for the iohexol program. In general, a quality improvement was revealed for the iohexol program over the metrizamide program. The 2 evaluators as well as the questioned investigators found the reporting standard of the iohexol trials significantly higher (p less than or equal to p less than or equal to 0.05) than that of the metrizamide trials.
Angiography↗
Iohexol in coronary angiography. A double blind investigation.
Iohexol 350 mg I/ml (Omnipaque) was compared with the routine contrast medium meglumine, Na-Ca-metrizoate 370 mg I/ml (Isopaque Coronar) in coronary angiography in 30 patients. A randomized, double blind, crossover design was employed. Angiographic image quality, ECG, heart rate, aortic blood pressure and adverse reactions were recorded. Excellent image quality was obtained with both media. Except for one single event of hypotension, only few and minor changes in the parameters measured were recorded. No distinct difference between the two media was found. Iohexol seems to be suitable for selective coronary angiography.
Adult↗
Suppression of follicular trapping of antigen-antibody complexes in mice treated with anti-IgM or anti-IgD antibodies from birth.
Mice were treated from birth with either goat anti-mouse IgM or with a monoclonal anti-IgD antibody. When they were 8 weeks old, cohorts of these mice were given 125I-labelled antigen, either by itself, or in an antigen-antibody complex. Anti-IgM-treated mice, which did not develop follicular structures in their spleens, failed to retain immune complexes on follicular dendritic cells in the characteristic pattern. Anti-IgD-treated mice, which had small follicles consisting of IgM+ IgD- B cells in their spleens, retained substantially smaller amounts of immune complexes than normal. These results support the concept that B lymphocytes transport antigen-antibody complexes to follicular dendritic cells. Furthermore, in the mouse it seems likely that this is mediated by both IgM+ IgD+ and IgM+ IgD- B cells.
Animals↗
Tolerability of iohexol after injection into healthy volunteers.
The effects of iohexol, a new non-ionic contrast medium, after intravenous injection into humans are reported. After injection of small doses into 2 subjects, iohexol was injected intravenously into 20 healthy male volunteers in doses of 125 to 500 mg I/kg body weight. A large number of physiologic, biochemical, hematologic and pharmacokinetic parameters were analysed. The results indicated that iohexol was well tolerated and that clinical trials in patients could be undertaken.
Adult↗
Iohexol in phlebography of the leg. A comparative investigation with meglumine metrizoate.
Comparing iohexol 240 mg I/ml, iohexol 300 mg I/ml and meglumine-Ca metrizoate 200 mg I/ml in phlebography of the leg in patients on or without anticoagulants, no sign of post-phlebographic thrombosis was found using the 125I-fibrinogen uptake test and repeat phlebography. More adverse reactions occurred with metrizoate than with iohexol. Metrizoate provided significantly poorer demonstration than the two iohexol concentrations with higher iodine content.
Adult↗