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Medical Products (medical + products)
Selected AbstractsImmunogenicity and effect of a virosomal influenza vaccine on viral replication and T-cell activation in HIV-infected children receiving highly active antiretroviral therapy,JOURNAL OF MEDICAL VIROLOGY, Issue 4 2006Elisabetta Tanzi Abstract In order to evaluate the immunogenicity and the effect of a virosomal influenza vaccine on viral replication and T-cell activation in HIV-infected children receiving highly active antiretroviral therapy (HAART), 29 children infected with HIV-1 vertically (19 primed with a previous influenza vaccination and 10 who were not been immunized against influenza) were immunized with an intramuscular virosome-adjuvanted influenza vaccine. According to the European Agency for Evaluation of Medical Products (EMEA) criteria, the immunogenicity of the vaccine was adequate against all three influenza strains (A H1N1, A H3N2, and B) in the primed children, and against A H1N1 and A H3N2 in the unprimed children. After in vitro stimulation with vaccine antigens, the IFN-, levels in the peripheral blood mononuclear cells cultures increased significantly from a baseline level of 103.0,±,229.8 pg/ml to a 30-day level of 390.7,±,606.3 pg/ml (P,<,0.05), with concentrations significantly higher (P,<,0.05) in the primed children than in the unprimed children. No increase in plasma HIV-1 RNA or HIV-1 proviral DNA was observed in either subgroup, and the immunophenotype analyses demonstrated that the CD4+ cell counts and percentages, the CD4/CD8 ratio and activated lymphocytes remained stable in either group from baseline to 1 month after each vaccine dose. This study showed that the virosomal influenza vaccine does seem to be immunogenic in the majority of HIV-infected children receiving HAART and does not induce viral replication or T-cell activation. Given the possible influenza-related complications in children infected with HIV, these results support the use of this influenza vaccine in such patients. J. Med. Virol. 78:440,445, 2006. © 2006 Wiley-Liss, Inc. [source] Accuracy of a new ultrafast rapid urease test to diagnose Helicobacter pylori infection in 1000 consecutive dyspeptic patientsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 2 2010D. VAIRA Summary Background, Rapid diagnostic tools for Helicobacter pylori are important in endoscopy. Aims, To assess the accuracy of a new 5 min rapid urease test (UFT300, ABS Srl, Cernusco sul Naviglio, Milan, Italy) and to compare it with the 1 h Pyloritek (Serim Laboratories, Elkhart, IN, USA) and the 24 h CLO test (Kimberly-Clark Ballard Medical Products, Roswell, GA, USA). Method, Consecutive dyspeptic patients referred to our unit for endoscopy were prospectively studied. All patients underwent a 13C-urea-breath test, histology and the UFT300 (ABS Srl; Cernusco sul Naviglio, Milan, Italy). In a sub-set of patients (n = 375), two additional RUTs were performed. Patients were deemed infected if both 13C-UBT and histology were positive. RUTs were read at 1, 5, and 60 min. Results, Of 1000 enrolled patients 45.3% were infected with H. pylori. The sensitivity of the UFT 300 was 90.3%, 94.5% and 96.2% at 1, 5 and 60 min respectively (specificity 100%). The Pyloritek and the UFT were comparable, but the CLO test was not reliable at 5 and 60 min. Conclusion, The UFT 300 test is comparable to the Pyloritek test, but the CLO test is significantly less sensitive at early time points. Reading test results at 1 min may increase false negative results, thereby decreasing sensitivity. Aliment Pharmacol Ther,31, 331,338 [source] Evaluation of the skin sensitizing potency of chemicals by using the existing methods and considerations of relevance for elicitationCONTACT DERMATITIS, Issue 1 2005David A. Basketter The Technical Committee of Classification and Labelling dealing with harmonized classification of substances and classification criteria under Directive 67/548/EEC on behalf of the European Commission nominated an expert group on skin sensitization in order to investigate further the possibility for potency consideration of skin sensitizers for future development of the classification criteria. All substances and preparations should be classified on the basis of their intrinsic properties and should be labelled accordingly with the rules set up in the Directive 67/548/EEC. The classification should be the same under their full life cycle and in the case that there is no harmonized classification the substance or preparation should be self-classified by the manufacturer in accordance with the same criteria. The Directive does not apply to certain preparations in the finished state, such as medical products, cosmetics, food and feeding stuffs, which are subject to specific community legislation. The main questions that are answered in this report are whether it would be possible to give detailed guidance on how to grade allergen potency based on the existing methods, whether such grading could be translated into practical thresholds and whether these could be set for both induction and elicitation. Examples are given for substances falling into various potency groups for skin sensitization relating to results from the local lymph node assay, the guinea pig maximization test, the Buehler method and human experience. [source] Effect of a water-based no-sting, protective barrier formulation and a solvent-containing similar formulation on skin protection from medical adhesive traumaINTERNATIONAL WOUND JOURNAL, Issue 1 2009Ronald J Shannon Abstract Trauma to the skin from repeated removal of adhesive-based medical products can cause pain, anxiety, risk of secondary infections and additional health care costs. Skin barrier formulations are used to protect the integrity from such trauma. However, not all formulations are equally protective. We report the results of a randomised controlled study comparing a solvent-free (SF) formulation and a solvent-containing (SC) formulation to the skin of 12 healthy volunteers aged 18,55 years. Treatments were applied at baseline to two of the four test sites on the back of each subject and repeated for 5 days. Measurements of pain, discomfort, erythema and skin water loss were taken 24 hours after each application. The SF formulation is associated with lower mean scores for erythema (day 5, P < 0·05) and lower values for transepidermal water loss (day 5, P < 0·05) and redness (days 4 and 5, P < 0·05) when compared with either no treatment or daily treatment with a SC formulation. There were no significant differences between subject responses when pain on application of the test formulation or discomfort associated with removal of the medical adhesive tapes were rated. We conclude that a SF formulation provides better security against adhesive-derived skin trauma than a SC formulation. [source] Predictive factors of self-medicated drug use among the Spanish adult populationPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2008P. Carrasco-Garrido PhD Abstract Purpose Our study aimed at describing the prevalence of self-medicated drug use among the Spanish adult population and to identify the predictive factors of such self-medication in Spain. Methods Descriptive, cross-sectional study covering the Spanish adult population, using data drawn from the 2003 Spanish National Health Survey (ENSS). A total of 19,514 subjects were analysed. The independent variables were socio-demographic and health-related, and the dependent variable was self-medicated drug use. Using logistic multivariate regression models we have estimated the independent effect of each of these variables on the self-medicated consumption. Results The 18.1% of all Spaniards indulge in self-medication. Our study shows that 45% of all cold and influenza medication and 39.4% of analgesics consumed by the population involve self-medication. It should be stressed here that 17.7% of persons who took antibiotics did so in the form of self-medication. The variables that were independently and significantly associated with a greater probability of self-medicated consumption were: sex; lower age; higher educational level; consumption of alcohol; smoking habit; use of alternative medical products; absence of chronic disease and a positive perception of health. Conclusions In Spain, the prevalence of self-medicated drug use is higher in women than men. In our population, the influence of unhealthy lifestyles, such as alcohol and tobacco consumption, is related to a higher likelihood of self-medication. Copyright © 2007 John Wiley & Sons, Ltd. [source] Guidelines for submitting adverse event reports for publication,,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 5 2007FISPE (Chair), William N. Kelly Pharm D Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide sufficient details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events. Copyright © 2007 Kelly et al. Reproduced with permission by John Wiley & Sons, Ltd. [source] Metallocene based polyolefin: a potential candidate for the replacement of flexible poly (vinyl chloride) in the medical fieldPOLYMERS FOR ADVANCED TECHNOLOGIES, Issue 9 2010M. C. Sunny Abstract A comparative assessment of the performance properties of metallocene polyolefin (m-PO) with those of plasticized poly (vinyl chloride) (pPVC) and ethylene vinyl acetate (EVA) copolymer having 18% vinyl acetate content (EVA-18), the two common polymers used for flexible medical products, is carried out. The preliminary evaluation of the processability, mechanical properties, and thermal stability of the new material, m-PO is described. The processability parameters like mixing torque and melt viscosity of m-PO are found to be comparable with those of pPVC and EVA-18. Mechanical properties such as tensile strength, elongation at break, and tear strength (TS) of m-PO are much higher than that of pPVC and EVA-18. Thermo gravimetric analysis (TGA) indicates that the thermal degradation of m-PO takes place only at temperatures above 340°C and can be processed at 170°C without much damage. Oxygen and carbon dioxide permeabilities of m-PO at three different temperatures (10, 25, and 40°C) are evaluated and compared with those of pPVC and EVA-18. It could be seen that the permeabilities of both the gases for m-PO at three temperatures were lower than those of pPVC and EVA. Biological evaluation of m-PO is carried out by assessing its cytotoxicity, hemolytic property, and blood clotting initiation. The cytotoxicity studies indicate that m-PO is non-toxic to the monolayer of L929 mammalian fibroblast cell lines on direct contact or the exposure of its extract. Non-hemolytic property of m-PO by direct contact as well as test on extract is revealed both in static and in dynamic conditions. Blood clotting time experiments indicate that the initiation of blood clotting due to m-PO is faster than that of pPVC and EVA-18. Copyright © 2009 John Wiley & Sons, Ltd. [source] Phosphatase inhibitors with anti-angiogenic effect in vitroAPMIS, Issue 1 2010LENE SYLVEST Sylvest L, Bendiksen CD, Houen G. Phosphatase inhibitors with anti-angiogenic effect in vitro. APMIS 2010; 118: 49,59. Levamisole has previously been identified as an inhibitor of angiogenesis in vitro and in vivo, but the mechanism behind the anti-angiogenic behavior has not yet been established. However, one known effect of levamisole is the inhibition of alkaline phosphatase, and this fact encouraged us to test other phosphatase inhibitors for their anti-angiogenic effects by using the same method as used to identify levamisole: an ELISA-based co-culture angiogenesis assay giving quantitative and qualitative results. Historically, intracellular phosphatases have been associated with the downregulation of signaling pathways, and kinases with their upregulation, but lately, the phospatases have also been coupled to positive signaling, which is why inhibition of phosphatases has become associated with anti-tumorigenic and anti-angiogenic effects. The results obtained in this work reveal several agents with anti-angiogenic potential and give a strong indication that phosphatase inhibition is linked to anti-angiogenic activity. An apparent disruption of endothelial tube formation was seen for seven of eight phosphatase inhibitors tested in the angiogenesis assay. By looking at the morphological results, it was seen that most of the inhibitors impaired proliferation and elongation of the endothelial cells, which still had a differentiated appearance. One inhibitor, PTP inhibitor IV, seemed to impair endothelial cell differentiation and induced the same morphology as when cells were treated with levamisole, although at a 200 times lower concentration than that of levamisole. Hence, our work points out compounds with a potential that may be of use in the search for new medical products for the treatment of malignant tumors, or other conditions where angiogenesis plays a central role. [source] Biopolymere in textilen Anwendungen.CHEMIE IN UNSERER ZEIT (CHIUZ), Issue 3 2009Polyhydroxyalkanoate, Polylactid Abstract Biopolymere stellen eine interessante Polymerklasse dar, deren Potential bisher noch nicht endgültig erfasst ist. Sie gewinnen jedoch zunehmend an Marktwert. Vor allem Polylactid (PLA) hat sich bereits durchsetzen können, da es nicht nur aus nachwachsenden Rohstoffen hergestellt werden kann und abbaubar ist, sondern darüber hinaus ein Eigenschaftsprofil aufweist, das mit herkömmlichen thermoplastischen Kunststoffen vergleichbar ist und sich auch ähnlich gut verarbeiten lässt. Das Anwendungsfeld der Biopolymere reicht von Folien, Obst- und Gemüseschalen bis hin zu Hygiene- und Medizinartikeln und ist daher sehr vielfältig. Diese Vielfältigkeit wird sicherlich in der Zukunft weiter zunehmen. Biopolymers represent an interesting class of polymers whose potential is not yet been fully realised. However, more recently, biopolymers are gaining impetus in the market. Among the biopolymers, polylactic acid (PLA) is being used successfully and is widely accepted because it is produced from natural raw material and is degradable. Furthermore, it has comparable properties to standard thermoplastic polymers and can also be processed using similar process channels as conventional thermoplastic synthetic materials. Biopolymer applications are manifold and range from foils, fruit and vegetable packaging to hygiene and medical products. It can be expected that in future the application spectrum of biopolymers will increase even further. [source] | ||||||||||