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Biomedical subjects

E Andrew

Publications and source records attributed to E Andrew.

At least 19 recordsLinked to original sources
PubMed2006

Clinical vs. laboratory identification of drugs of abuse in patients admitted for acute poisoning.

OBJECTIVE: The extent of drug abuse in patients admitted for self-poisonings is uncertain. The aim of this study was to assess the pattern of drugs of abuse among patients admitted for acute poisoning according to age and gender, and to study the concordance between the clinical assessments by the physicians on duty and the drug analyses. METHODS: Prospective cross sectional study of all patients (n = 405, 52% males, median age 31 years) treated for acute poisoning in our department during one year (2001). The physician on-call classified type of drug of abuse by history and clinical assessment. This was later compared to urine and blood samples analysed for ethanol, benzodiazepines, opiates, cocaine, ecstasy, GHB, amphetamine and cannabis. RESULTS: In 320 admissions (79%), the comparison between clinical diagnosis and laboratory analyses could be performed. A total of 478 drugs were suspected and 621 were found. The main toxic agents found were benzodiazepines (49.7%), ethanol (40.3%), opiates (35.3%), cannabis (23.8%) and amphetamine (21.3%). Ninety-two had used drugs of abuse. The agreement between clinical assessments and laboratory findings was best for GHB and ethanol (kappa = 0.43), and for opiates (k = 0.38). For benzodiazepines and cannabis, the concordance was poor (k = 0.18 and 0.10, respectively). However, the correct clinical evaluation for these substances was 59% and 77%, respectively. CONCLUSIONS: Drugs of abuse were more frequently found than suspected clinically. Benzodiazepines, ethanol and opiates were most common. The agreement between clinical assessment and drug analyses was moderate to low. Physicians seem to underestimate the use of these drugs.

Acute Disease↗
PubMed1998

Late allergy-like reactions following vascular administration of radiography contrast media.

PURPOSE: To compare the frequency of allergy-like reactions in adults following vascular injection of iohexol and iopentol versus other contrast media (CMs), with emphasis on late reactions. MATERIAL AND METHODS: Thirty-two trials involving a total of 2,656 patients in the European clinical development programmes for iohexol and iopentol were retrospectively evaluated. The number of patients experiencing late allergy-like reactions, immediate allergy-like reactions, and both types of reaction were pooled separately. Late was defined as time of onset being 60 min or more after the first injection of CM. RESULTS AND CONCLUSION: After vascular administration of iohexol and iopentol, 0.52% (0.44% and 0.68% respectively) of the patients experienced a late allergy-like reaction. The same frequency was reported for immediate allergy-like reactions. After administration of ionic CMs, the frequency of late allergy-like reactions was in the same range (0.42%) as for non-ionic CMs, but the frequency of immediate allergy-like reactions was much higher (6.99% vs 0.52%). Our results are in the same range as those reported by other authors. No serious adverse reactions were reported in the 32-trial series.

Contrast Media↗
PubMed1996

Safety, tolerance, and pharmacokinetics of iodixanol injection, a nonionic, isosmolar, hexa-iodinated contrast agent.

RATIONALE AND OBJECTIVES: A review of clinical-chemical parameters and tolerability of iodixanol is presented. Iodixanol is a newly developed dimeric, ratio 6 radiographic contrast medium formulated to be isotonic to plasma in all concentrations by the balanced addition of electrolytes. We summarize completed trials of iodixanol. RESULTS: The increase in femoral blood flow following administration of iodixanol was significantly smaller than that seen with most other nonionic contrast media. Iodixanol appears to have less impact than other nonionic media on renal tubular function. Unlike iohexol and ioxaglate, the rate of adverse events after iodixanol administration was essentially the same for normal patients as for patients at increased risk for negative reactions (patients with previous adverse reactions to contrast administration). The risk following administration of iodixanol also appears to be similar in normal patients and in patients with other risk factors, including those with a history of congestive heart failure, renal insufficiency or disease, asthma, diabetes, hypertension, or vascular disease. A significant reduction in the sensation of injection-associated heat and pain was noted for iodixanol versus ioxaglate. Cardiac electrophysiologic measurements and contractility revealed minimal interference from iodixanol. CONCLUSION: Iodixanol is a safe and effective nonionic, isotonic contrast medium that may offer clinical advantages.

Animals↗
PubMed1995

Elimination of the non-ionic X-ray contrast media iodixanol and iohexol in patients with severely impaired renal function.

Iodixanol (Visipaque) and iohexol (Omnipaque) are dimeric and monomeric, respectively, non-ionic X-ray contrast media (CM), with well-characterized pharmacokinetics in healthy volunteers. This study was undertaken to study the pharmacokinetics of the contrast media in patients with severely impaired renal function. A total of 16 patients referred for preoperative abdominal angiography were randomized to form two groups of eight patients, receiving either iodixanol 320 mgI ml-1 or iohexol 350 mgI ml-1. Urine and faeces were sampled before the examination and collected quantitatively for five days afterwards, and blood samples were drawn frequently. The concentrations of iodine and contrast medium in urine and in serum, and the amount of iodine in faeces were determined. Mean baseline creatinine clearance was 13.6 and 9.9 ml min-1 1.73 m-2 in the iodixanol and iohexol groups, respectively. Patients in the iodixanol group received on average 0.34 gI per kg bodyweight (bw) and those in the iohexol group 0.39 gI per kg bw. The semilogarithmic plots of serum concentration of CM vs. time indicated elimination according to a two-compartment model. The mean elimination half-life was 23.0 h for iodixanol and 27.2 h for iohexol, and the mean apparent volume of distribution was similar for the two CM, ranging from 0.20 to 0.30 1 per kg bw. Mean plasma clearance of iodixanol was 10.4 ml min-1 1.73 m-2 and 6.9 ml min-1 1.73 m-2 for iohexol, whereas the mean renal clearances were 8.7 and 6.1 ml min-1 1.73 m-2, respectively. Mean faecal recovery was 8.2% for iodixanol and 6.1% for iohexol, and the respective figures for that in urine were 76.1 and 74.8%. Renal clearance of radiolabelled iothalamate, a marker of glomerular filtration rate (GFR), measured simultaneously, indicated that both CM were eliminated by the kidneys by glomerular filtration only. Thus, both media are suitable as GFR markers.

Aged↗
PubMed1993

Oral magnetic particles. Results from clinical phase II trials in 216 patients.

Oral magnetic particles (OMP) have been evaluated in a clinical phase II trial program comprising 216 patients in 7 European centers. Adult patients referred for MR imaging for various abdominal pathologies were examined. The patients received OMP at a concentration of 0.1 g/l (ultralow field) or 0.5 g/l (mid/high field) and OMP was diluted in water or in a more viscous liquid formulation. Depending on the area of interest, OMP was ingested in a volume of 300 to 800 ml. OMP was well tolerated with no serious adverse events and the patient acceptability was good. OMP had a good contrast effect on all applied pulse sequences. The viscous formulation of OMP was homogeneously distributed through the entire gastrointestinal tract without inducing disturbing susceptibility artifacts. The postcontrast diagnostic information was improved in 70% of the cases. Based on the encouraging results in phase II, OMP has been advanced to phase III clinical trials.

Abdomen↗
PubMed1993

Incidence of roentgen contrast medium reactions after intravenous injection in pre-registration trials and post-marketing surveillances.

The relative risk of adverse drug reactions of ionic versus non-ionic contrast media injected i.v. were compared for different types of trials using odds-ratio. The absolute and relative risk found in large post-marketing trials were compared with that found in the iohexol pre-registration trials. The absolute risks were 2 to 10 times higher in the pre-registration trials compared to the post-marketing surveillances. The relative risk for all adverse drug reactions was 3 to 6 times higher for ionic vs. non-ionic media and independent of pre- or post-registration studies. The odds-ratio seems to be a feasible method of comparing the relative risk of adverse reactions in various trials.

Contrast Media↗
PubMed1992

Human pharmacokinetics of iodixanol.

The pharmacokinetic properties of the x-ray contrast medium, iodixanol, a new nonionic dimer, were investigated in a phase I study including 40 healthy male volunteers. Iodixanol (300 mg I/mL) was administered intravenously (i.v.) at four dose levels--0.3, 0.6, 0.9, and 1.2 g iodine (I)/kg body weight--and saline was given as a control. 51Cr-EDTA was given concomitantly with iodixanol at all dose levels to study renal excretion of iodixanol. Mean half-lives were 26 and 131 minutes in the distribution and elimination phase, respectively. Apparent volume of distribution was 0.28 1/kg body weight, indicating distribution to extracellular fluid only. Within 24 hours after injection, 97% of the dose was excreted unmetabolized in the urine via glomerular filtration. The excretion in feces was 1.2% of the dose. The parameters calculated were independent of the given dose. The pharmacokinetics of iodixanol are comparable with those reported for other intravascular contrast media.

Adult↗
PubMed1992

Detection of cytokines at the site of tuberculin-induced delayed-type hypersensitivity in man.

Cytokines are chiefly local mediators which play an important role in the regulation of the cell-cell interactions which may be involved in the development of the delayed-type hypersensitivity (DTH) reaction. Using immunohistochemical techniques, the presence of IL-1 alpha, IL-1 beta, IL-6, interferon-gamma (IFN-gamma) and tumour necrosis factor-alpha (TNF-alpha) in the skin in tuberculin-purified protein derivative (PPD)-induced DTH reactions was investigated in six normal individuals. Cells staining for these cytokines were first observed 6 h after PPD challenge, and they were detected throughout the duration of the 7-day experiment. The number of cells staining for IFN-gamma reached a peak at 48 h, where 33% of the total aggregate cells were positive, but declined thereafter to 3% at day 7. On the other hand, the number of cells staining for TNF-alpha and IL-1 persisted at high levels throughout the observation period of 7 days (e.g. at 48 h and thereafter, about 40% cells positive for TNF-alpha and 20% for IL-1 alpha and IL-1 beta). Double immunofluorescence and staining on sequential sections showed that IFN-gamma-staining cells were CD3+ T cells; TNF-alpha, IL-1 and IL-6 staining cells were mainly of the CD68+ macrophages/monocytes and that 80% of the CD1a+ cells (Langerhans-like cells) in the dermis contained TNF-alpha and IL-1. The presence of these cytokines at the site of inflammation suggests that they may be locally produced by the inflammatory cells. Their persistence during the reaction suggests that they are intimately associated with this response, and are involved in the development of the reaction.

B-Lymphocytes↗
PubMed1991

[Iodixanol. A new isotonic x-ray contrast medium].

In this phase I study, safety, tolerance and pharmacokinetics of iodixanol 300 mg I/ml, were evaluated in 40 healthy male volunteers using four dose levels. No clinically important influences on renal function parameters, hemodynamics, ECG or clinical-chemical parameters in blood and urine were observed. 17 adverse events including discomfort were reported, but only three of them (sensation of warmth) were classified as related to iodixanol. CT-investigations revealed a dose-related, reversible increase in kidney cortex density. However, iodixanol caused no changes in glomerular function, and the increase in excretion of tubular enzymes was less than caused by other nonionic x-ray contrast media. Further investigations will focus on the safety and efficacy of iodixanol in patients.

Adult↗
PubMed1990

Renal effects of the non-ionic contrast medium iopentol after intravenous injection in healthy volunteers.

Renal effects of the new non-ionic contrast medium iopentol in increasing doses were assessed and compared with the effects of physiologic saline. Twenty-four healthy male volunteers, allocated to three dose groups, were given iopentol intravenously in doses of 0.3, 0.6, and 1.2 g I/kg body weight, respectively. The highest dose group was also given physiologic saline separately as a control. The diuresis increased in all groups, most in the highest dose group, and with a concomitant fall of urine osmolality and increase in osmolar clearance. A slight decrease of serum osmolality, creatinine and urea occurred at 3 hours due to hemodilution. The glomerular filtration rate was unaffected by iopentol. The urinary excretion of albumin and beta 2-microglobulin was unchanged. However, urinary N-acetyl-beta-glucosaminidase and alkaline phosphatase increased significantly, most in the highest dose group. All changes were reversible.

Acetylglucosaminidase↗
PubMed1989

Safety and toleration of the non-ionic contrast medium iopentol. An intravenous phase I trial.

The safety and toleration of iopentol, a new non-ionic contrast medium for intravascular use, were evaluated. In the intravenous phase I study, 24 volunteers were allocated to 3 dose groups corresponding to 0.3, 0.6 or 1.2 g I/kg body weight, respectively. Injection of saline was used as control in the highest dose group. Adverse events, hemodynamic parameters, and clinical chemical parameters in the blood and urine were recorded. No severe or unexpected adverse events occurred. All findings were transient and included a sensation of warmth, a small increase in heart rate, a dilution effect on blood parameters, and enzymuria. The deviations in clinical chemical parameters fell mostly within reference ranges and were clinically insignificant. Thus, iopentol may safely be advanced to clinical trials in patients for comparative studies.

Adult↗
PubMed1988

Clinical trial program for iopentol. A new nonionic ratio 3.0 contrast medium with emphasis on clinical phases I and II.

Iopentol is a new nonionic, water-soluble ratio 3.0 roentgen contrast medium (CM) for vascular use. The aim is to present the vascular clinical trial program for iopentol and to report the findings from the clinical phases I and II. The clinical program started with an intravenous (IV) safety and pharmacokinetic phase I trial (24 volunteers) and continued with six open, noncomparative phase II trials (61 patients) for studying cardiovascular and arterial tolerance (two trials in cardioangiography), venous tolerance (two trials in IV computed tomography [CT] enhancement), and cerebral and arterial tolerance (2 trials in cerebral arteriography). One volunteer in the phase I trial was excluded because of a vasovagal reaction following saline injection, and four patients were protocol deviators in cardioangiography. Mainly renal glomerular filtration of unmetabolized iopentol, close to 100% recovered after 24 hours in the urine, was found in the phase I study. No unexpected or severe contrast-induced reactions were encountered in phases I and II. Good diagnostic efficiency was obtained in phase II. As also expected, iopentol seemed to be well-tolerated. However, its relative efficiency and tolerance profile can only be documented from the ongoing comparative phase III trials.

Contrast Media↗