Regulatory requirement for three dose levels in rodent genetic toxicity assays.
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Biomedical subjects
Publications and source records attributed to S Galloway.
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The purpose of this study was to describe the symptom distress, anxiety, depression, and discharge information needs of patients after peripheral arterial bypass surgery. Patients (n = 38) were interviewed before and after hospital discharge. The symptoms of incisional pain and broken sleep, as measured by Visual Analogue Scales, were the most distressing symptoms experienced before and after discharge. Patients reported low levels of anxiety and depression as measured by the Profile of Mood States. A moderate amount of information, assessed by the Patient Learning Need Scale, was perceived by patients to be important to help manage their care after discharge. The most important information related to the recognition, prevention, and management of complications. The findings contribute to an understanding of discharge information needs after peripheral arterial bypass and emphasizes the importance of patient education to facilitate transition to the home.
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The relationship between patients' perceived informational needs and selected sociodemographic and illness-related variables were examined in a sample of 301 adult medical and surgical patients preparing for discharge from an acute care setting. Marital status, living arrangements and chronicity of illness had no influence on the importance of informational needs as measured by the Patient Learning Need Scale (PLNS). More informational needs were identified by females than males, and those with malignant as opposed to benign disease. Length of time spent in the hospital, number of discharge medications, and patient perception of the influence of the illness on life were positively correlated with informational needs at the time of discharge.
The article describes the development and initial psychometric evaluation of an instrument to measure patients' perceptions of learning needs at time of discharge from hospital to home. Evaluation of the Patient Learning Needs Scale was based on responses of 301 adults hospitalized with a medical or surgical illness. Factor analysis isolated seven subscales: medications, activities of living, feelings related to condition, community and follow-up, treatment and complications, enhancing quality of life and skin care. These seven factors accounted for 56.1% of the variance. Cronbach's alpha for the 50-item scale was 0.95.
The failure of dream psychology to delineate clear, consistent and interesting correlates of dream recall presents serious difficulties for the claim that dream recall is functionally significant. The present study examined the relation of six indices of boundary functioning and four measures of life affect to the consistency and frequency of dream recall in 373 young adults. Factor analysis indicated that consistency and frequency of dream recall were unrelated to global measures of boundary functioning, stress, depression, hassles and uplifts. On the assumption that the correlates of dream recall might be specific rather than global, 34 items from our expanded boundary questionnaire having significant zero order correlations with the frequency of dream recall were factor analyzed separately for consistent and inconsistent recallers. The two factors in each analysis were quite similar. Factor one was called the Imagination, factor two, Illusion. Among consistent recallers, dream recall and a group of items called "tough mindedness" loaded on the Imagination factor. For inconsistent recallers similar variables loaded on the Illusion factor. For all subjects, dream recall and tough mindedness were linked whether associated with Imagination or Illusion. The Imagination factor is creative and linked to dream recall for consistent recallers. Their illusion factor is frightening. For inconsistent recallers, the Illusion factor is linked to dreaming and is not frightening, and their Imagination factor is not creative. The stability-instability of dream generation and recall over time apparently results in the association of the dream recall tough-mindedness group of items with either the Imagination or Illusion factors.
Lymphocyte cultures from 4 individuals with persistently significantly elevated frequencies of sister-chromatid exchange (SCE) were examined with no treatment, and with 2 concentrations of mitomycin C. In each of the 4 cases, the mean level of SCEs in the untreated lymphocytes exhibited a paradoxical reduction in SCE frequency when exposed to the lower (0.005 microgram/ml) of the two doses of mitomycin C. At the second higher dose of mitomycin C (0.025 microgram/ml) the mean level of SCE/cell exceeded the untreated mean. When the distributions of SCE/cell were examined it appeared that the untreated cultures had two or more populations of cells; one was in the normal SCE frequency range, while the second population was in an elevated SCE frequency range. The paradoxical reduction in SCE frequency was apparently due to elimination of, or mitotic inhibition of cells in the highest range of SCE frequency, while a small elevation in SCEs was initiated in the cells with a normal SCE frequency. Thus, mean levels of SCE/cell can be misleading. This data suggests that new exposure to the same or a different genotoxic agent might possibly result in a misleading lowering of the mean SCE frequency.
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Theobromine (3,7-dimethylxanthine) was evaluated for genotoxic activity in a series of in vitro assays. Theobromine was not mutagenic in the Ames assay up to a maximum concentration of 5000 micrograms/plate either with or without S9 activation. The compound also failed to induce significant levels of chromosome aberrations in CHO cells (with and without S9 activation) or transformation in Balb/c-3T3 cells. At the maximum tolerated concentration theobromine increased the frequency of TK-/- mutants in mouse lymphoma L5178Y cells. Increased frequencies were observed both with and without S9 activation and they were reproducible in 2 independent experiments. Statistically significant increases in SCEs were obtained in human lymphocytes and in CHO cells under nonactivation test conditions. The spectrum of results in this battery of tests indicate that theobromine treatment results in the expression of genotoxic potential in some assays and the observed activity appears qualitatively and quantitatively similar to that of caffeine, a closely related methylxanthine.
Cocoa powder was evaluated for genotoxic activity and found to be inactive in the Ames assay, the mouse lymphoma assay, cytogenetic assays measuring chromosome breakage and SCE, and a cell transformation assay using Balb/c-3T3 cells. Although pure theobromine has been shown to be active in some of these test procedures, the levels of this methylxanthine present in cocoa powder were insufficient to elicit responses in this battery of tests.
We compared doxorubicin and metabolite pharmacokinetic data obtained from thin-layer chromatography (TLC) and high-performance liquid chromatography (HPLC) assay of plasma samples from six patients who had been treated with doxorubicin. Duplicate 1-ml samples were extracted with chloroform: isopropanol (1:1) and assayed using a sensitive HPLC system incorporating a dual pump gradient with tetrahydrofuran as the mobile phase and fluorescence detection. Duplicate 1-ml samples from the same specimens were assayed using a modification of a previously described TLC assay. Areas under the curve for doxorubicin by HPLC (3.36 +/- 2.30 microM X h) and TLC (4.16 +/- 2.50 microM X h) were not significantly different (P = 0.5). Terminal half-life of doxorubicin by HPLC (28.0 +/- 6.98 h) and TLC (23.2 +/- 7.8) (P = 0.29) and the calculated total-body clearances by HPLC (0.55 +/- 0.29 l/min) and TLC (0.45 +/- 0.23) (P = 0.55) were not significantly different. Areas under the curve for doxorubicinol by HPLC (2.75 +/- 1.4 microM X h) and TLC (2.53 +/- 7.1 microM X h) (P = 0.73) showed no significant differences. HPLC detected a mixed 7-deoxydoxorubicinol aglycone-doxorubicin aglycone peak, 7-deoxydoxorubicin aglycone, and two nonpolar, unidentified metabolites. TLC detected the following aglycone metabolites: doxorubicin aglycone, doxorubicinol aglycone, 7-deoxydoxorubicinol aglycone, an unidentified polar metabolite, and several unidentified nonpolar metabolites. From these data we conclude that HPLC and TLC detect concentrations of doxorubicin and doxorubicinol from human plasma equally well to concentrations of 7.0 nM (4 pmol injected doxorubicin). Aglycones do circulate in human plasma at concentrations above the detection limits of both assays. Doxorubicinol aglycone, which is detected by TLC but not by HPLC, may be formed from artifactual breakdown of doxorubicinol during TLC development. Unidentified nonpolar compounds seen on HPLC and TLC may represent further doxorubicin metabolism than previously described.
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Four patients with hepatocellular carcinoma, shunting of blood from the hepatic artery to the portal vein, and hyperkinetic portal hypertension were treated by transcatheter embolization of the hepatic artery. In three acutely bleeding patients variceal hemorrhage was controlled by the embolization. Following embolization hepatofugal portal venous flow became hepatopetal in all four patients. No serious complications were encountered. When hepatoma is complicated by arterioportal shunting and hyperkinetic portal hypertension, occlusion of the fistula by transcatheter embolotherapy can reduce the portal pressure.
Twenty-two patients with colonic arterio-venous malformations (AVM) are reported and 218 other cases in the English literature are reviewed. Of our patients, 16 (73%) underwent right hemicolectomy because of repeated episodes of rectal bleeding or iron-deficiency anemia. Ten (63%) of these patients have remained in good health with no further evidence of intestinal bleeding after surgery. In six (37%) recurrent episodes of rectal bleeding or iron deficiency anemia have gone unexplained despite thorough work-up including repeat arteriography. Our experience and that in the literature suggests: 1. Most AVM's (78%) occur in the cecum or right colon, the jejunum being the next most common site. 2. Patients with AVM's tend to be elderly with a strong history of cardiovascular disease. A potential association between aortic stenosis, intestinal bleeding, and AVM's is suggested. However, prospective studies are needed to confirm this relationship. 3. In younger patients AVM's tend to occur at atypical sites such as the small bowel. 4. Surgical removal of an AVM cannot be expected to be uniformly curative. The causes of recurrent bleeding after surgery include: incomplete resection of the initial AVM, occult AVM's missed on arteriography and left behind at surgery, and the appearance of new AVM's postoperatively. The cause of bleeding in many patients with recurrence however, remains undiagnosed despite repeat angiography.
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A retrospective clinical and radiological review of 51 patients (mean age 66 years) was performed to assess the outcome of excision arthroplasty for hallux valgus in an elderly population and to compare the results of the Keller, which is still used frequently in many centers in the United Kingdom, and modified Mayo operations. Although significant correction of the deformity was obtained with both procedures, this was incomplete and the mean residual hallux valgus angle was greater than 20 degrees. Lateral metatarsalgia was present in over 40% of patients. Both procedures provided good pain relief, and considerable narrowing of the forefoot was obtained with the modified Mayo operation. Excision arthroplasty in the elderly should be reserved for the low demand patient with symptomatic degenerative changes in the first MP joint in the absence of lateral metatarsalgia.
Until recently, surgical resection of the liver was done mainly for benign or traumatic conditions. Liver resections are now an accepted treatment for primary and some metastatic cancers of the liver. Nurses play an important role in the management of all liver resection patients and need to have an understanding of the anatomy and physiology of the liver, the tests performed during the preoperative period, the surgery performed, and the physiologic and psychologic responses of the patients during the postoperative period.