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Biomedical subjects

J R Trout

Publications and source records attributed to J R Trout.

At least 19 recordsLinked to original sources
PubMed2004

Ultrase MT12 and Ultrase MT20 in the treatment of exocrine pancreatic insufficiency in cystic fibrosis: safety and efficacy.

BACKGROUND: Cystic fibrosis causes exocrine pancreatic insufficiency, leading to malabsorption. Supplemental pancreatic enzyme therapy alleviates the concomitant malnutrition experienced by cystic fibrosis patients. It is recognized that patients experience variations in clinical response to different brands of enzymes. This has prompted the US Food and Drug Administration to require that enzyme supplements be subjected to New Drug Applications. AIM: To investigate the safety and efficacy of supplemental pancreatic enzyme therapy in cystic fibrosis subjects. METHODS: We compared two doses of one formulation of enteric-coated pancreatic enzymes: Ultrase MT12 (12,000 lipase units per capsule) and Ultrase MT20 (20,000 lipase units per capsule), to placebo in two separate safety and efficacy studies. RESULTS: Mean total fat, protein and carbohydrate intake did not differ significantly between the groups. A significant difference in both fat and protein absorption occurred with the enzyme therapy groups. The Ultrase MT12 and Ultrase MT20 groups experienced a mean fat and protein absorption 79.4% and 83.8%, and 87.3% and 88.6%, respectively. No adverse events related to study drug were reported. CONCLUSIONS: This study further supports the use of enzymes to treat pancreatic insufficiency in cystic fibrosis. Excellent fat and protein absorption was achieved with minimal adverse events and safe doses.

Adolescent↗
PubMed1999

Metaanalysis of the safety and efficacy of an adhesion barrier (Interceed TC7) in laparotomy.

OBJECTIVE: To evaluate the safety and efficacy of an oxidized, regenerated, cellulose adhesion barrier (Interceed TC7) in the reduction of pelvic adhesions. STUDY DESIGN: Clinical studies published or completed by December 31, 1994, evaluating the barrier used at laparotomy were considered for a metaanalysis. RESULTS: Of 10 studies (n = 560) identified, data from 7 (n = 389) met the inclusion criteria for determining the reduction in the incidence of adhesions and 5 (n = 311) for determining the reduction in adhesion extent (raw surface area after adhesiolysis). There was a 24.2 +/- 3.3% difference in the incidence of adhesions (P < .001) between barrier-treated and untreated sites. Adhesion-free outcomes were 1.5-2.5 times more likely at barrier-treated sites than at sites with good surgical technique alone (odds ratio = 2.89; 95% confidence interval = 2.15-3.90). Barrier treatment resulted in a greater reduction (1.1 +/- 0.4 cm2) in adhesion extent (raw surface area) than good surgical technique alone (P < .001). Four adverse events were recorded; they were typical of those seen after surgery. No event was considered to be definitely related to the use of the barrier. CONCLUSION: The barrier significantly reduced the incidence and extent of adhesions as compared with no treatment, confirming the conclusion from individual studies that it is safe and effective in pelvic laparotomy surgery.

Cellulose, Oxidized↗
PubMed1998

The rates of adhesion development and the effects of crystalloid solutions on adhesion development in pelvic surgery.

OBJECTIVE: To document rates of adhesion development after abdomino-pelvic surgery, stratified by adhesion type, access method, and use of crystalloid solution instillates. DESIGN: Reports from a MEDLINE search (1/1/1966-12/18/1996) detailing rates of adhesion development and meeting the inclusion criteria were subjected to meta-analysis. SETTING: Meta-analysis. PATIENT(S): Patients undergoing abdomino-pelvic surgery. INTERVENTION(S): Intraperitoneal crystalloid solution instillates. MAIN OUTCOME MEASURE(S): Percentage adhesion-free outcome in patients ("patients") or surgical sites ("sites"). RESULT(S): Adhesion-free outcome (sites) was lowest for reformed (26.3% laparotomy; 14.3% laparoscopy), higher for de novo 1b (direct trauma) (45.2% laparotomy, 37.2% laparoscopy), and highest for de novo 1a (indirect trauma) adhesions (82.4% laparoscopy). Crystalloid solution instillates reduced adhesion-free outcome at sites (45.2% versus 20% de novo 1b adhesions in laparotomy) and in patients (43.5% versus 19.9% reformed, laparotomy; 71.7% versus 25% de novo 1b, laparoscopy). CONCLUSION(S): Adhesion-free outcome was lowest for reformed, higher for de novo 1b, and highest for de novo 1a adhesions. Surprisingly, it was lower in laparoscopy than in laparotomy for de novo 1b and reformed adhesions. Crystalloid instillates did not increase adhesion-free outcome. Although limited by the retrospective and heterogeneous nature of the data, these conclusions nonetheless provide a basis on which to formulate future hypotheses.

Crystallization↗
PubMed1998

Longitudinal study of urinary hydroxy-pyridinium cross-links and growth in healthy infants: higher values with breastfeeding and after daytime sleep.

Urinary pyridinoline and deoxypyridinoline crosslinks (crosslink) are excreted when bone is resorbed. The aims of this study in healthy infants were to determine whether crosslinks a) could predict growth velocity, b) are variable due to circadian rhythm, and c) differ in infants who were either breast-fed or formula-fed. In 78 healthy infants (48 male; 30 female) urine samples were collected and anthropometric measurements were taken at 2, 3, 4, 5, 6, 8, 10 and 12 months of age. In addition, a total of 25 samples were collected during the day (0700-2000) in 5 of the infants to determine circadian rhythm of crosslink excretion. Crosslink excretion decreased (p < 0.001) with age between 2 and 12 months. Pyridinoline excretion showed a significant, but weak correlation (r > or = 0.21; p < 0.05) with linear growth velocity and weight velocity in the subsequent month until 6 months of age, and no correlation thereafter. Infants studied for circadian rhythm showed a 63% greater (p < 0.05) rate of pyridinoline excretion after a nap as compared to the 13-hour mean value. In a subset of infants whose energy intake was exclusively from breast milk (BF, n = 23) or formula (FF, n = 10), crosslink excretion was greater in BF infants at 3 months of age (p < 0.05). The correlations between crosslink excretion and growth parameters indicate that crosslinks may be useful as a marker of growth in infant populations. However sources of variation in crosslink excretion, such as circadian rhythm and diet may limit their utility to predict growth in an individual infant. These factors should be considered in future studies examining markers of bone turnover in infants.

Age Factors↗
PubMed1997

Yohimbine elimination in normal volunteers is characterized by both one- and two-compartment behavior.

We sought to determine the safety, pharmacodynamic response, and single- and multiple-dose pharmacokinetic profile of yohimbine hydrochloride. Thirty-two healthy volunteers received 6 days of yohimbine, 5.4 mg 3 times daily (t.i.d.), 10.8 mg t.i.d., 16.2 mg t.i.d., or 21.6 mg twice daily (b.i.d.), with determination of plasma catecholamine levels and mood/anxiety-inventory scores. The pharmacokinetic profile of yohimbine was determined after the first and last dose. Yohimbine exhibited one-compartment elimination in most subjects, with dose-dependent increases in maximal concentration (Cmax) and area under the curve (AUC) but no evidence of drug accumulation. At least two subjects in each cohort exhibited two-compartment elimination of yohimbine, with nonsignificant increases in day 7 AUC, Cmax, and terminal elimination half-life (t1/2beta). Plasma catecholamine levels increased significantly in relation to both average yohimbine AUC and Cmax, but there were no significant effects on heart rate, blood pressure, or anxiety/mood-inventory scores. The single- and multiple-dose pharmacokinetic profile of yohimbine exhibits a substantial degree of interpatient and intrapatient variability, possibly resulting from variability in first-pass and hepatic metabolism. There is a significant correlation between plasma norepinephrine levels and yohimbine AUC or Cmax. Further multiple-dose studies are warranted definitively to address the relation between yohimbine AUC or Cmax and pharmacologic effect.

Adult↗
PubMed1997

Comparison of Infasurf (calf lung surfactant extract) to Survanta (Beractant) in the treatment and prevention of respiratory distress syndrome.

OBJECTIVE: To compare the relative safety and efficacy of Infasurf (calf lung surfactant extract; ONY, Inc, Amherst, NY, IND #27169) versus Survanta (Beractant, Ross Laboratories, Columbus, OH) in reducing the acute severity of respiratory distress syndrome (RDS) when given at birth and to infants with established RDS. DESIGN: A prospective, randomized, double-blind, multicenter clinical trial. SETTING: Thirteen neonatal intensive care units participated in the treatment arm: seven of these concurrently participated in the prevention arm. PATIENTS: The treatment arm enrolled infants of </=2000 g birth weight with established RDS, and the prevention arm enrolled infants of </=29 weeks' gestation with birth weights <1250 g. INTERVENTION: Infants were randomly assigned to receive Infasurf (n = 303, treatment arm; n = 180, prevention arm) or Survanta (n = 305, treatment arm; n = 194, prevention arm) in accordance with the Survanta package insert instructions. OUTCOME MEASURES: We projected a 25% reduction between groups in the need for a third dose of surfactant for infants with established RDS, and a 25% reduction in the need for a second dose of surfactant for infants who received prophylactic surfactant. Secondary outcomes included the severity of RDS measured by inspired oxygen concentrations and mean airway pressure, air leaks, complications associated with surfactant administration, and survival to 36 weeks' postmenstrual age without the need for oxygen supplementation. RESULTS: In the treatment arm, there was no difference between groups in the number of infants requiring more than two doses of surfactant. The interval between doses was significantly longer for Infasurf, suggesting an increased duration of treatment effect. The inspired oxygen concentration and mean airway pressure were lower in the Infasurf infants during the first 48 hours in the treatment arm. In the prevention arm, there were no differences with respect to the number of surfactant doses. The dosing intervals were longer for Infasurf infants after the second dose. No difference in inspired oxygen or mean airway pressure was noted during the first 72 hours. There were no significant differences in the incidence of air leaks, complications associated with dosing, complications of prematurity, mortality, or survival without chronic lung disease in the prevention or treatment arm. CONCLUSIONS: Infants treated with Infasurf have a modest benefit in the acute phase of RDS. Infasurf seems to produce a longer duration of effect than Survanta.

Age Factors↗
PubMed1996

Effects of yohimbine on autonomic measures are determined by individual values for area under the concentration-time curve.

A study was conducted to examine tolerability and pharmacodynamics of single doses of yohimbine in healthy volunteers using measures of mood, heart rate, blood pressure, and serum catecholamine levels. Participants were given single oral doses of yohimbine hydrochloride as high as 21.6 mg. Plasma concentrations of yohimbine, epinephrine, norepinephrine, and MHPG (3-methoxy-4-hydroxyphenylethylene-glycol) were quantified by means of high-performance liquid chromatography with electrochemical detection. Mood was assessed by visual analogue scale (VAS), the Profile of Mood States, and the Spielberger State Anxiety Index. Yohimbine was well tolerated and rapidly absorbed and eliminated. Dose-related increases in area under the concentration-time curve (AUC) were observed. Administration of yohimbine in the presence of a high fat meal diminished both the rate and extent of drug absorption. Significant intersubject variability in the pharmacokinetic parameters of yohimbine was observed, with some individuals exhibiting greatly increased oral bioavailability of yohimbine. Increases in blood pressure, respiratory rate, plasma catecholamine levels, and total VAS score were observed in participants with elevated AUC values. The AUC of yohimbine had the largest effect on total VAS score. The results indicate that higher doses of yohimbine are both well tolerated and produce dose-related increases in AUC, which are associated with more pronounced autonomic effects. Increases in respiratory rate and plasma MHPG appear to be the most reliable pharmacodynamic measures for single oral doses of yohimbine. Individual differences in the pharmacokinetics of yohimbine are important in determining pharmacodynamic effects and should be considered in evaluations of its clinical effectiveness.

Adrenergic alpha-Antagonists↗
PubMed1993

Plant and marine n-3 fatty acids inhibit experimental metastasis of rat mammary adenocarcinoma cells.

The effectiveness of dietary n-3 plant and marine fatty acids and n-6 gamma-linolenic acid (GLA) was tested as an antimetastatic modality in the experimental model of metastasis of 13762MAT:B mammary adenocarcinoma cells. Weanling female Fischer 344 rats were placed on one of the following diets: 1-23.52% blackcurrant oil (BCO), II-23.52% corn oil (CO), III-15.52% BCO + 8% fish oil (FO), IV-20.52% FO + 3% CO, and V-5% CO. After 8 weeks, 15 rats per group were injected i.v. with 10(5) cells and diets were continued until sacrifice. In the 23.52% CO group (II), the number of small (< 2 mm) and large (> 2 mm) lung metastatic foci and their total volume were significantly greater than the BCO- and/or FO-fed groups (I, II and IV). Although the number of small metastatic foci was comparable in the 5% and 23.52% CO groups, the number of large foci and the total tumor volume were reduced in the 5% CO group. These results suggest that, compared to a low-corn oil diet or a high-fat diet containing a mixture of marine and plant n-3 fatty acids plus n-6 GLA, a 23.52% corn oil diet can enhance experimental metastasis of mammary adenocarcinoma cells. Total number of metastatic foci and tumor volume were the smallest in group III, receiving a combination of plant and marine n-3 fatty acids.

Adenocarcinoma↗
PubMed1988

Fenfluramine-induced behavior changes in rats prefed serotonin-altering amounts of tryptophan and pyridoxine.

It has been well established that elevated dietary tryptophan (TRP) levels can increase brain serotonin concentrations, thereby influencing serotonergic transmission. We previously examined interaction between dietary substrate (TRP: 0.15 and 0.6%) and the cofactor precursor (pyridoxine HCl: 3 and 3,000 mg/kg) on brain serotonin metabolism, observing significant increases in serotonin concentrations from such dietary interaction. The present experiments were designed to explore possible behavioral consequences of the substrate-cofactor interaction. After the IP injection of fenfluramine (FA: at 5, 10, 15, and 20 mg/kg), serotonin-mediated behavior traits and the appearance of flushing were observed in rats fed experimental diets as stated above. With a 5 mg/kg dose of FA, a differential dietary effect was most visible. However, at higher FA levels (15 and 20 mg/kg), such dietary effects were no longer discernible. The appearance of flushing was also dependent on dietary TRP intake and the dosage of FA. These results indicate a clear substrate-cofactor interaction on certain serotonin-mediated behavior traits in the rat.

Animals↗
PubMed1984

Food dyes produce minimal effects on locomotor activity and vitamin B-6 levels in postweanling rats.

We investigated the effects of food dye consumption on locomotor activity, brain neurotransmitters, tissue vitamin B-6 levels, and hepatic cytochrome P-450 concentrations in postweanling rats. Animals were individually housed in stabilimeter-type activity cages for 4 1/2 weeks, and fed ad libitum a semipurified basal diet containing graded levels (4, 2, 1, 0.5 or 0%) of a blend of all seven Food, Drug and Cosmetic (FD & C) food dyes. Rats in the 4% dye group were significantly (P less than 0.001) less active during the first 3 weeks of dietary treatment, but no significant differences existed among groups during the final 10 days. Similarly, although dye ingestion depressed food intake (P less than 0.0025) and body weight (P less than 0.05) when averaged for all animals, the differences among groups disappeared by the last week of the experiment. Postmortem tissue analyses revealed no significant effect of dyes on brain tissue levels of serotonin, dopamine, norepinephrine, 5-hydroxyindoleacetic acid or homovanillic acid. Moreover, no significant differences were detected in either plasma and brain tissue levels of pyridoxal phosphate or in hepatic cytochrome P-450 concentrations. These results demonstrate that animals may adapt to the chronic consumption of food dyes and do so with minimal evidence of toxicity. Our data also suggest that previously reported behavioural abnormalities attributed to food dyes are probably unrelated to altered vitamin B-6 metabolism.

Administration, Oral↗
PubMed1984

Milk yield by Dorset ewes as affected by sibling status, sex and age of lamb, and measurement.

Milk intake (sucking-test weight) by 55 Dorset lambs and milk production (oxytocin-hand milking) by 41 Dorset ewes were measured at 2-wk intervals during the first 8 wk of lactation. Each method indicated that milk yield by ewes was greater at 2 and 4 wk of lactation than at 6 and 8 wk. Daily milk intake by a set of twins (suckling-test weight) was similar to 24-h milk production of their dam (oxytocin-hand milking) when lambs were 2, 4, 6, and 8 wk of age. At 2, 4, and 6 wk postpartum, milk production by ewes nursing single lambs was 200 to 400 g greater than milk intake by lambs due to a larger residual milk. Stage of lactation had a significant effect on protein and fat content of milk but not on lactose. Sex of offspring had no effect on milk yield or protein, fat, and lactose content of milk. Lactose was one percentage unit greater in milk of ewes nursing single lambs; however, the amount of lactose secreted daily was similar for ewes nursing single or twin lambs. Twenty-four-hour milk production by the ewe as determined by the oxytocin-hand milking method was correlated with lamb growth (.67 to .86), with milk intake, as determined by the suckling-test weight method, the next most important variable. Milk composition contributed little toward modeling lamb growth.

Age Factors↗
PubMed1984

Blood constituents in lactating Holstein cows influenced by hematocrit, sampling site, and diet protein and calcium.

Constituents were measured in jugular vein (days 0, 4, 14, 28, 43, 72, and 151 of lactation) and internal iliac artery and mammary vein (days 28, 72, and 151 of lactation) blood of 24 Holsteins. Six diets of grain:corn silage-urea contained percents of protein and calcium: 12, .6; 12, .9; 15, .6; 15, .9; 15, .6; 15, .9. Grain contained urea (diets 3, 4) or soybean meal (diets 5, 6). All cows were fed diet 3 the first 4 wk of lactation; then four cows were assigned to each of six diets. In jugular blood, calcium and phosphorus were lower on day 0. Hydroxyproline and ketone bodies peaked and magnesium was minimal on day 4. Hematocrit, urea nitrogen, and free fatty acids decreased with lactation. Jugular blood from younger cows had less ketone bodies, free fatty acids, and magnesium and more hematocrit, hydroxyproline, and phosphorus. Sampling site had arterial-venous differences for each constituent, with venous differences for hematocrit, free fatty acids, calcium, phosphorus, and magnesium. Hematocrit decreased with diets 1, 2, 3, 4, or .6% calcium. With a common hematocrit (36%) and change from baseline (day 28), urea nitrogen was less with 12% protein or .6% calcium. Phosphorus and magnesium decreased with 15% protein. More constituents were required from diet and tissues to maintain concentrations in blood as hematocrit decreased, indicating the importance of dietary calcium and protein concentration and quality.

Age Factors↗
PubMed1980

Adipocyte size distribution in fa/fa rats during development.

Epididymal fat pad adipocyte frequency distributions of obese (fa/fa) and nonobese (non-fa/fa) Zucker rats were determined from 2 to 20 wk of age. The fa/fa rats consistently displayed a higher proportion of larger adipocytes than the non-fa/fa rats of all ages studied. Increased adipocyte size preceded an increase in the number of adipocytes during the early phases of obese development. Among the fa/fa rats, the frequency of small cells continued to increase, which resulted in a bimodal distribution by 20 wk of age. Discriminant analysis suggests that the differences in adipocyte size frequency distributions at 2 wk of age may be another useful means to identify fa/fa and non-fa/fa pups prior to expression of overt obesity. Increased fat storage may reflect the lower energy expended by the very young fa/fa rats.

Adipose Tissue↗
PubMed1976

Hydroxyproline in serum as a homeostatic index for calcium in cattle.

Hydroxyproline, calcium, magnesium, phosphorus, and alkaline phosphatase values were determined in serum over 24 h in Holstein cows. The cows represented two age groups and three percents of diet calcium. Hydroxyproline followed a cyclic pattern dipping at 0800 and 1600 h after milking at 0500 and 1530 h. Phosphorus showed a 24 h rhythm peaking at 1600 h. No other time effects were demonstrated. Hydroxyproline and alkaline phosphatase were both lower in the older cows, indicating a decreased calcium mobilization from bone with age. There was a correlation coefficient of only .20 between serum calcium and hydroxyproline. The calcium concentration in serum was maintained within a narrow range presumably as a result of homeostatic mechanisms involving bone resorption, i.e. the release of calcium and hydroxyproline may indicate the degree of homeostasis required to maintain serum calcium.

Age Factors↗