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Biomedical subjects

P B Pedersen

Publications and source records attributed to P B Pedersen.

At least 19 recordsLinked to original sources
PubMed2004

Toxicological studies on Lactose Oxidase from Microdochium nivale expressed in Fusarium venenatum.

A new carbohydrate oxidase, Lactose Oxidase, with high specificity of oxidizing the disaccharide lactose to lactobionic acid has been found. This enzyme opens up for a variety of applications. A programme of toxicological studies was conducted to establish the safety of Lactose Oxidase to be used as a processing aid in the food industry. The enzyme used in this study was produced by a submerged fermentation of Fusarium venenatum and contained a gene code from Microdochium nivale. Oral administration to rats of up to 10 mL/kg bodyweight (bw)/day (equivalent to a total organic solids dosage of 900 mg/kg bw/day or a Lactose Oxidase dosage of 344 LOXU/kg bw/day) for 13 weeks did not cause any adverse effect. Lactose Oxidase was not found to be mutagenic in the bacterial reverse mutation assay, nor did it cause chromosomal aberrations in cultured human lymphocytes. The maximum recommended dosage of Lactose Oxidase is 50 LOXU/kg liquid whey protein concentrate. The safety margin for exposure is estimated to be at least 6.2 x 10(4) for daily diary product consumption. In conclusion Lactose Oxidase can be considered as safe for use in the food industry.

Administration, Oral↗
PubMed2003

Safety evaluation of a glucanase preparation intended for use in food including a subchronic study in rats and mutagenicity studies.

An enzyme preparation containing glucanase produced by the fungus Trichoderma harzianum is intended to be used to improve the clarification and filtration of wines. The safety of a glucanase preparation was assessed in a series of toxicological tests to document its safety in use. Oral administration to rats of up to 10 mL/kg bw/day (equivalent to a total organic solids dosage of 1258 mg/kg bw/day or a glucanase dosage of 1882 BGXU/kg bw/day) for 13 weeks did not cause any adverse effect. The test substance was not found to be mutagenic in the bacterial reverse mutation assay, nor did it cause chromosomal aberrations in cultured human lymphocytes. The safety margin for exposure is estimated to be in the range of 2100-72,000 depending on the estimate for daily wine consumption. The results of these studies demonstrate that an enzyme preparation containing glucanase may be considered safe when employed in wine processing.

Administration, Oral↗
PubMed2002

Toxicological studies on Laccase from Myceliophthora thermophila expressed in Aspergillus oryzae.

The bioindustrially produced enzyme laccase can be used in different technical and food applications to facilitate processes. It can be added to different oral care products such as mouthwash, toothpaste, mints, and gums to prevent halitosis. Laccase, produced by submerged fermentation of Aspergillus oryzae, containing a gene originating from Myceliophthora thermophila, was subject to a series of toxicological tests to document its safety in use. It was not found to be mutagenic in the Salmonella typhimurium reverse mutation assay, nor did it cause chromosomal aberrations in cultured human lymphocytes. No evidence of inhalation toxicity or skin and eye irritation was found. There was no evidence of possible skin sensitization in a human skin sensitization test when Laccase was tested at 10% (w/v): thus Laccase would appear to have a low skin sensitization potential. Oral administration to rats of up to 10.0 mL/kg body wt/day (equivalent to a total organic solids dosage of 1.72 g/kg body wt/day) for 13 weeks did not cause any adverse effect.

Administration, Inhalation↗
PubMed2002

Cytotoxic potential of industrial strains of Bacillus sp.

The cytotoxic potential of selected strains of Bacillus licheniformis, Bacillus amyloliquefaciens, and Bacillus subtilis, used in the production of industrial enzyme products, has been assessed. Cytotoxicity was determined in Chinese hamster ovary (CHO-K1) cells by measuring total cellular metabolic activity using the tetrazolium salt 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT). Initially the MTT assay was validated against toxigenic strains of Bacillus cereus, to define the exact criteria for a toxigenic versus a nontoxigenic response. The assay proved sensitive to culture broths of both a diarrheagenic strain and an emetic strain of B. cereus. The enzyme-producing strains tested were nontoxic to CHO-K1 cells. Additionally it was demonstrated that our industrial strains did not react with antibodies against B. cereus enterotoxins by use of commercial antibody-based kits from Oxoid and Tecra. A short survey of the literature concerning the toxigenic potential of species within the subtilis group is included, as is a database search of known B. cereus enterotoxins against B. subtilis and B. licheniformis DNA sequences.

Animals↗
PubMed2002

Toxicological studies on Polyporus pinsitus laccase expressed by Aspergillus oryzae intended for use in food.

The laccase used in the study was produced by submerged fermentation of Aspergillus oryzae, containing a gene originating from Polyporus pinsitus. Laccase is to be employed as a processing aid in the juice industry to make a clear and stable juice. The enzyme was subject to a series of toxicological tests to document its safety in use. It was not mutagenic in the Salmonella typhimurium reverse mutation assay, and it did not cause chromosomal aberrations in cultured human lymphocytes. No evidence of inhalation toxicity or skin and eye irritation was found. Oral administration to rat of up to 10 ml kg(-1) b.w. day(-1) (equivalent to a total organic solids dosage of 676 mg kg(-1) b.w. day(-1) or a laccase dosage of 2601 LACU kg(-1) b.w. day(-1)) for 13 weeks did not cause any adverse effect. The maximum recommended dosage of laccase used for juice applications is 50 LACU l(-1) juice.

Administration, Inhalation↗
PubMed2000

Toxicological studies on Thermomyces lanuginosus xylanase expressed by Fusarium venenatum, intended for use in food.

The xylanase used in this study was produced by a submerged fermentation of Fusarium venenatum and contained a gene code originating from Thermomyces lanuginosus. The enzyme was subject to a 13-week toxicological test in rats and in vitro tests to document its safety in use. The enzyme is to be applied as a processing aid in the baking industry to improve handling and stability of dough. The enzyme was not found to be mutagenic in the Salmonella typhimurium reverse mutation assay, nor did it cause chromosomal aberrations in cultured human lymphocytes. Oral administration to rats of up to 10.0 ml/kg bw/day (equivalent to a Total Organic Solids dosage of 1.12 g/kg bw/day or a xylanase dosage of 89422 FXU (W)/kg bw/day) for 13 weeks did not cause any adverse effect.

Administration, Oral↗
PubMed1999

The fungal metabolite culmorin and related compounds.

This paper reviews the toxicology of culmorins, a family of compounds found in grains contaminated by Fusarium graminearum and related fungi. We include the results of an Ames test and studies based on Quantitative Structure-Activity Relationships. Culmorin has low toxicity in several in vitro assays and in one study in swine and is Ames test negative. Culmorin is moderately antifungal. QSAR analysis suggested that the plant compound longifolene was similar. Longifolene is a GRAS compound used in cosmetics and is also moderately antifungal.

Antifungal Agents↗
PubMed1996

The cultural context of psychology: questions for accurate research and appropriate practice.

This article summarizes the contents of the recent conference, "The Cultural Context of Psychology," held in New York City in August 1995. Using an innovative format of small-group discussions, 22 facilitators posed a total of over 100 key unanswered questions in multicultural psychology. There questions, organized along three categories-awareness, knowledge, and skills-form the foundation of this article. This article serves as a cognitive map for needed research and discussion on multicultural issues in mental health. The references were carefully selected to provide the interested reader with resources for follow-up work on the topics presented.

Cross-Cultural Comparison↗
PubMed1995

Culture-centered counseling skills as a preventive strategy for college health services.

All learning occurs in a cultural context. Successful counseling can be achieved by training healthcare providers to interpret behaviors in their cultural context. The author describes a culture-centered approach, using a cultural grid that matches same/different behaviors with same/different expectations. Clients with shared positive expectations may display dissonant and apparently negative behaviors. Culturally accurate knowledge and culturally appropriate skills provide a three-level developmental sequence for more accurate and more appropriate healthcare guidance in such multicultural settings as those met on the college campus.

Communication Barriers↗
PubMed1993

Safety evaluation of esperase.

Esperase is a proteolytic enzyme preparation that can be used as a processing aid in the food industry. The following studies were performed to establish safety for the consumer: oral toxicity study (13 wk) in the rat; teratogenicity study in the rat; gene mutation assays in Salmonella typhimurium and mammalian cells in vitro, and chromosome aberration assay in vitro. General toxicity was low; the effects seen were attributed to proteolytic activity and the loading with sodium chloride. Neither of these factors will be relevant to consumers of the processed food. There was no evidence of effects on pregnancy outcome or mutagenic potential. When these results are considered together with existing knowledge of the production organism and the chemical and microbiological characterization of the enzyme preparation, they indicate that Esperase will be safe for its intended application in food processing.

Abnormalities, Drug-Induced↗
PubMed1991

Serious systemic infection caused by non-encapsulated Haemophilus influenzae biotype III in an adult.

Haemophilus influenzae is the aetiological agent in less than 1% of septic arthritis cases in adults and most often serotype b is involved. We report here a case of severe systemic infection due to non-encapsulated H. influenzae biotype III in a 40-year-old man, previously healthy although alcohol abuser. Cholangitis and acute alcoholic hepatitis were diagnosed simultaneously. The organism was grown from blood and from synovial fluid of the left knee, but several other joints were also affected. The close relationship between H. influenzae biotype III and H. aegyptius is mentioned in view of recent reports of fatal childhood illness caused by a special clone of H. aegyptius and the importance of reporting both serotype and biotype in severe H. influenzae induced disease is emphasized.

Acute Disease↗
PubMed1991

Elastolytic activity of human monocytes from synovial fluid and blood of patients with arthritis. Relations to levels of interleukin 6 and soluble interleukin 2 receptor.

Synovial fluid (SF) and blood from 24 patients with non-traumatic, sterile hydarthron were examined for monocyte elastolysis (MøE) and for levels of interleukin 6 (IL-6) and of soluble interleukin 2 receptor (sIL-2R). Six patients had osteoarthrosis (OA) and 18 patients had inflammatory hydarthron (IH), 10 of whom had rheumatoid arthritis (RA). Blood MøE was lower in OA than in IH, both measured as basal MøE activity and after in vitro stimulation with immune complexes and phorbol myristate acetate (PMA). SF MøE was higher than MøE in blood (p less than 0.01). This increase in SF MøE could be mimicked in vitro by prestimulation of blood Mø with low levels of IC. SF IL-6 and sIL-2R were also elevated (p less than 0.01). All three parameters correlated to the degree of joint inflammation evaluated by SF leucocyte level, complement activation, blood C Reactive Protein, and to the clinical evaluation of the joint. The increase in SF MøE, IL-6 and sIL-2R in patients with IH, points to a stimulation of Mø and lymphocytes in the joint.

Adult↗
PubMed1990

Penicillamin-induced neuropathy in rheumatoid arthritis.

A case of penicillamin-induced severe polyradiculopathy in rheumatoid arthritis is presented. The neuropathy was of demyelinating type, purely motor, proximal and clinically fully reversible when the drug ceased. In case of a progressive neuropathy, during penicillamin treatment, this adverse effect should be born in mind, and discontinuation of the drug considered.

Arthritis, Rheumatoid↗
PubMed1987

Safety evaluation of Streptomyces murinus glucose isomerase.

A glucose isomerase enzyme, obtained from Streptomyces murinus, was produced by a fermentation process and subjected to a series of tests to investigate its safety in use and manufacture. It was not mutagenic (Ames test, using liquid culture) nor did it provoke chromosomal damage (rat bone marrow cytogenetics test). It did not contain (nor did the organism produce) antimicrobial activity or macrolidpolyene antibiotics. It had no teratogenic activity when administered to pregnant rats at 100,000 ppm in the diet. It was without effect upon rats when administered at this dietary concentration for 4 weeks. Dietary administration at 5000, 15,000 or 50,000 ppm to rats for 13 weeks resulted in nephrocalcinosis in females at all dosages (probably a physiological response to the altered calcium:phosphate ratio in the admixed diet) and status spongiosus in the brains of males receiving 50,000 ppm. As the finding of nephrocalcinosis in rats is generally agreed to be of no toxicological importance with regard to the use in man, the dietary concentration of 15,000 ppm was considered to be highest no-effect level. This level corresponds to an intake of some 1000 mg/kg/day, which represents approximately 8000 times the human intake based on a conservative estimation.

Aldose-Ketose Isomerases↗
PubMed1984

Relapse prevention of duodenal ulcers with trimipramine, cimetidine, or placebo. A double-blind comparison.

In a double-blind study 83 patients with duodenal ulcers, initially healed after treatment with either 1 g cimetidine daily or 50 mg trimipramine daily, were allocated by randomization to maintenance treatment with either 400 mg cimetidine daily, 25 mg trimipramine daily, or placebo for 6 months. Monthly clinical interviews were carried out and endoscopy performed whenever the symptoms suggested ulcer relapse. After 6 months the treatment was discontinued, and the patients were observed similarly for another 6-month period. After 6 months of maintenance treatment 88% in the cimetidine group versus 55% in the trimipramine group and 53% in the placebo group remained in symptomatic remission, yielding a significant difference between the cimetidine-treated patients and the two other groups (P less than 0.05). After a further 6 months of drug-free follow-up study, the percentages were 48% versus 29% and 29% in the cimetidine, trimipramine, and placebo groups, respectively (P less than 0.05). Thus maintenance treatment with trimipramine proved no better than placebo in preventing relapses of duodenal ulcers. Second, maintenance treatment with 400 mg cimetidine daily did prevent ulcer relapse, and, third, maintenance treatment with cimetidine for 6 months did not alter the long-term course of the duodenal ulcer disease.

Adult↗
PubMed1983

Efficacy of trimipramine and cimetidine in the treatment of duodenal ulcer. A double-blind comparison.

One hundred and fourteen consecutive outpatients with endoscopically proven duodenal ulcers were allocated in a double-blind study to treatment with either trimipramine (Surmontil), 50 mg at bedtime, or cimetidine (Tagamet), 200 + 200 + 200 + 400 mg/day, using identical-appearing active and placebo tablets to fill in the treatment scheme. One hundred and eight patients completed the study. Ulcer healing was assessed by endoscopy at 3, 6, and 9 weeks. Clinical symptoms and antacid consumption were recorded by means of interviews and a diary card system. The cumulated healing rate with cimetidine and trimipramine, respectively, was at 3 weeks 64% versus 40% (p less than 0.05), at 6 weeks 89% versus 65% (p less than 0.05), and 9 weeks 91% versus 78% (n.s.). We found no significant differences between the two groups with regard to pain relief, antacid consumption, or general symptomatic improvement.

Adolescent↗