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Biomedical subjects

W Fleischer

Publications and source records attributed to W Fleischer.

29 records · Page 2Linked to original sources

Assessment of analgesia in man: tramadol controlled release formula vs. tramadol standard formulation.

OBJECTIVE: The present study tested analgesia produced by a new controlled release formulation of tramadol. The investigation employed an experimental pain model based on chemo-somatosensory event-related potentials (CSSERP) in response to painful chemical stimuli applied to the nasal mucosa. STUDY: Twenty healthy volunteers participated in the experiments, which followed a controlled, randomised, double-blind, 3-way cross-over design. Each of the three medications (tramadol 100 mg [T100], tramadol controlled release 100 mg [TCR100] and tramadol controlled release 150 mg [TCR150]) was administered orally to fasting subjects. There was at least a 6 day washout period between tests. Each experiment was divided into five sessions, which took place before and 2, 4, 6, and 12 h after drug administration. In addition to the assessment of CSSERP, subjects rated the intensity of both the tonic and phasic painful stimuli. Nonspecific drug effects were also monitored by means of frequency analysis of the spontaneous EEG, ratings of adverse effects, and the subjects' performance in a tracking task. RESULTS: The significant reduction of amplitude N1 at central recording positions indicated that TCR 150 was the most effective analgesic 12 h after administration. Both 6 and 12 h after administration TCR 100 was more effective in terms of analgesia compared to T100. In addition, TCR100 appeared to produce fewer adverse effects than the standard formulation of tramadol. CONCLUSIONS: The controlled release formulation can be expected to become a valuable tool in peroral therapeutic regimens for chronic pain.

Adult↗

[Pain therapy for patients with tumor diseases. Quality assurance].

Medical care for patients with cancer is in worldwide discussion about the therapeutic goals. Additionally to cancer therapy, pain therapy and symptom control is getting more and more attention. The definition of structural quality aspects, process quality and resulting quality provides a valuable tool for analyzing status and goals in cancer pain therapy. In this paper, we present a computerized documentation program which leads through pain analysis to initiation, evaluation and control of therapeutic results following WHO-guidelines. Information is offered during the documentation procedure. The program fills therapeutical (documentation) gaps during everyday practice concerning pain and symptom control in cancer patients. The program presents a kind of "on demand" continuing education.

Curriculum↗

[A new inhalation system for bronchodilatation. Study of the acceptance of the Ingelheim M inhaler in chronic obstructive respiratory tract diseases].

The aim of this study was to investigate the acceptance and convenience of a new inhalation system for the treatment of chronic obstructive pulmonary disease. The Ingelheim M inhalator, an inhalation system with a supply magazine for six powder-filled capsules represents a further development of the Ingelheim inhalator in which only a single capsule can be utilized. The study was designed as an open, randomized, crossover trial involving 60 ambulatory adult patients. Each treatment period lasted two weeks. The medication tested was Berodual Inhaletten. The success of treatment was checked on the basis of peak flow metering each morning prior to and after initial inhalation. The results of the study show a highly significant preference on the part of the patients for the new inhalation system. The advantage most emphasized by the patients was the fact that they were able to carry with them their entire daily dose. Differences in the symptomatology of chronic obstructive pulmonary disease were not observed with these inhalation systems.

Adolescent↗

[New technics for producing inhalation aerosols--initial experiences and results with the piezoelectric inhalation device].

In the treatment of chronic obstructive airway diseases, the inhalative application of medicaments with a bronchodilatory effect is given preference throughout the world. In addition to inhalation solutions and powder capsules, so-called metered-dose aerosols have formed an established part of the treatment plan for approximately 30 years now. With the piezoelectric inhalation device, a fully portable ultrasonic atomiser that is small enough to fit within the pocket, has been developed for the first time. In this device, the piezoelectric effect is utilised to produced, pressure-free, microfine aerosols. Within it, an accurately metered volume containing the therapeutic dose is applied to an atomising element oscillating in the ultrasonic range. The particle spectrum generated with the piezo-system corresponds, in terms of size, to that of metered aerosol devices, and the mean particle diameter is approximately 2.1 microns. The atomisation process takes approximately one second.

Aerosols↗

Relation between cell cycle stage and the activity of DNA-synthesizing enzymes in cultured human lymphoblasts: investigations on cells separated according to DNA content by way of a cell sorter.

Exponentially growing human lymphoblasts (culture LS-2) were separated by cell sorting (FACS II, Becton Dickinson) according to their deoxyribonucleic acid (DNA) content, designating them at particular phases of the cell cycle. Prior to cell sorting the DNA has been fluorochrome-labeled with the Hoechst stain H 33342. Maximum cell enrichments of 94% for G0 + G1 cells, 96% for S cells and 74% for G2 + M cells could be achieved. The enzyme activities of thymidine kinase (TK), thymidylate synthase (TS), DNA polymerase (DNA-P), dihydrofolate reductase (FH2-R), methionine synthase (MS), and hexokinase (HK) were determined in the obtained cell fractions. Although incorporation of 3H-thymidine (3H-dTR) and the 3H-dTR labeling index were significantly inhibited by the dye, no evidence of cell staining's having a significant effect on the enzyme activities was found. The enzyme activities for approximately 100% pure G0 + G1, S, and G2 + M cells were computed. With exception of TK, all the enzymes under study were shown to exhibit activities--although of differing degree--in the G0 + G1, S, and G2 + M cells. No TK activity was shown in G0 and G1 cells; its activity, however, was approximately the same in S and G2 + M cells. This applies likewise for TS which, in contrast to TK, exhibits minor activity in G0 + G1 cells. DNA-P was highly active in G0 + G1 cells, but maximum activity was in S cells. FH2-R exhibited maximum activity in S cells, although the difference in activity between S and G2 + M cells was not significant. None of the observed differences in MS activity was significant, indicating equally high activity in cells of all cell cycle phases. HK activity is approximately twice as high in G2 + M cells as in G0 + G1 cells.

Benzimidazoles↗

New method for easy labeling of beta-2-agonists in the metered dose inhaler with technetium 99m.

The actual deposition pattern of micronized drugs from metered dose inhalers (MDI) is incompletely known because there are no methods available to label the drugs (beta 2-agonists) with gamma-emitters. Indirect measurements of the distribution of the drug in man differed greatly due to the method used. Our method uses the better solubility of 99mTcO4- in the beta 2-agonist-micronized drug in relation to the propellant with surfactant. The principle is to extract the 99mTcO4- from the original water phase into the liquid phase of the propellant with ethyl methyl ketone. For labeling the micronized drug particles, the original MDI must be cooled to -60 degrees C and some labeled propellant (including surfactant) with high specific activity of 99mTcO4- is added through an aperture in the bottom of the container. The aperture is sealed with a screw. After rewarming the MDI, more than 90% of the added 99mTcO4- is dissolved in the beta 2-agonist-micronized drug in relation to its volume. This is proved by comparing the distribution of the radioactivity component with chemical analysis. The pattern of deposition of both MDIs - placebo and beta 2-agonist-micronized drug - was shown to be similar in healthy volunteers. With a labeled MDI a preliminary study with 2 different inhaling maneuvers was performed in 7 volunteers: inhaling from residual volume after a pause of 2 s the intrabronchial deposition was 18.7%, and inhaling at 50% of vital capacity maneuver the intrabronchial deposition was 33.0%. The data obtained with actual measurement of the inhaled drug from MDI suggest greater intrabronchial deposition than was assumed before in the literature.

Adrenergic beta-Agonists↗

Polyvinyl pyrrolidone-iodine liposome hydrogel improves epithelialization by combining moisture and antisepis. A new concept in wound therapy.

Moist treatment of wounds has been shown to improve epithelialization, however at an increased risk of bacterial infection. In this monocentric, randomized, open, phase II pilot study of polyvinyl pyrrolidone-iodine, a well-established topical antiseptic was tested in a new liposomal complexed form in patients receiving meshed skin grafts after burns or reconstructive procedures. Mesh skin graft sites of 36 patients were dressed either with the new polyvinyl-pyrrolidone-iodine liposome hydrogel formulation (Betasom hydrogel) (n = 21), or chlorhexidine-gauze (n = 15). After the first dressing change, wounds were assessed daily and documented every other day until they were healed. Methods of analysis included clinical assessment, photoplanimetry (rate of epithelialization), impedance measurement (moisture of surface and wound healing quality), patient's assessment of pain and other sensations, and thyroid hormones (T3, T4, and TSH). The rate of epithelialization was improved with Betasom hydrogel compared to chlorhexidine-gauze on day 11 (96.3% vs. 75.9% p = 0.056) and significantly on day 13 (100% vs. 82.3% p = 0.005), respectively. Impedance measurements showed an earlier return to normal values (day 9) in Betasom-hydrogel-treated wounds as opposed to chlorhexidine treatment (day 11). Clinical assessment indicated significantly better antiseptic efficacy (p = 0.002) and wound healing quality (p = 0.004) of Betasom hydrogel. Graft loss occurred at a significantly lower rate in Betasom treatment (n = 1; 5%), than in chlorhexidine treatment (n = 5; 35.7%) (p = 0.001). No relevant adverse events or clinically relevant changes of thyroid hormones were observed with Betasom hydrogel. The rationale of this new polyvinyl pyrrolidone-iodine liposomal formulation was based on the properties of liposomes that provide higher moisture to the wound surface, release PVP-iodine at a low rate, and target the substance more exactly by interaction with the cell surface. These initial clinical results show earlier epithelialization and better healing in wounds treated with polyvinyl pyrrolidone-iodine liposome hydrogel, which combines moisture and antisepsis, compared to wounds treated with a conventional antiseptic chlorhexidine-gauze.

Adult↗

Virucidal and chlamydicidal activities of eye drops with povidone-iodine liposome complex.

Povidone-iodine (PVP-I) is a broad-spectrum microbicide with in vitro activity against bacteria, viruses, fungi and protozoans. A 5% solution of PVP-I proved to be highly effective in ophthalmic surgery for the prophylaxis of endophthalmitis. For the antiseptic treatment of eye infections a novel application form of PVP-I has been developed by using a PVP-I liposome complex which demonstrated an excellent antimicrobial efficacy. In this study it could be shown that the novel liposomal formulations containing 2.5 or 5% PVP-I were as active as the aqueous solution against herpes simplex virus type 1, adenovirus type 8, coxsackievirus A9 and Chlamydia trachomatis in cell culture referring to equal PVP-I concentrations. Long-term cytotoxicity experiments demonstrated a moderate cytotoxicity for both formulations with a better tolerability of the liposomal PVP-I formulation compared with the aqueous solution. There is no evidence for a genotoxic activity of these agents.

Adenoviruses, Human↗