Ergebnisse der Studie "CHARISMHA - Chancen und Risiken von Gesundheits-Apps"

Albrecht U-V. Ergebnisse der Studie "CHARISMHA - Chancen und Risiken von Gesundheits-Apps". Presented at the BfArM im Dialog: Medical-Apps -- Chancen, Risiken, Herausforderungen, Bonn, Germany

Validierung der abschließenden Desinfektion von semikritischen Medizinprodukten mittels Wischdesinfektion

Die Frage, ob die gesetzlich geforderte Validierbarkeit der Aufbereitung von semikritischen Medizinprodukten (z. B. Ultraschallsonden mit Schleimhautkontakt) auch mittels der seit vielen Jahren bereits vielfach verwendeten Desinfektionswischtüchern vollumfänglich erfüllt werden kann, wird in Fachkreisen schon länger diskutiert. Die vollständige Information zur fachlichen Einschätzung der für Medizinprodukte zuständigen obersten Landesbehörden, des Bundesinstituts für Arzneimittel und Medizinprodukte (BfArM) und des Robert Koch-Institut (RKI) wird im vorliegenden Beitrag ungekürzt wiedergegeben.Peer Reviewe

Cytochrome P450 inhibitory action of echinacea preparations differs widely and co-varies with alkylamide content

Echinacea preparations are one of the best selling herbal medicinal products with a well established therapeutic use in the prophylaxis of upper respiratory tract infections. Their consumption is increasing, but information about their ability to inhibit cytochrome P450 enzymes (CYP) is fragmentary. The picture is further complicated by a lack of phytochemical characterization of previously tested preparations. Due to its well characterized immunomodulatory activity, the standardized Swiss registered Echinacea purpurea (L.) Moench Echinaforce extract was selected for detailed study. With the single baculovirus-expressed CYP isoforms 1A2, 2C19, 2D9 and 3A4, inhibitory actions were measured by monitoring fluorescent metabolites derived from enzyme substrates (supersome assay). The Echinaforce extract induced mild inhibition of all these isoforms, with CYP 3A4 being the most, and CYP 2D6 the least sensitive enzyme. To assess whether CYP inhibition might be a general feature of Echinacea preparations, an additional nine commercially available preparations were screened using CYP 3A4. All tested preparations were able to inhibit CYP 3A4, but inhibitory potencies (expressed as median inhibitory concentration, IC50) varied by a factor of 150. The alkylamides are thought to be responsible for the immunomodulatory activity of Echinacea, and so the concentration of 2E,4E,8Z,10E/Z-tetranoic acid isobutylamide (1) and total alkylamide content were determined in all preparations, and the latter was found to be associated with their CYP 3A4 inhibitory potency. The chemically pure alkylamides dodeca-2E,4E,8Z,10E/Z-tetranoic acid isobutylamide (1) and dodeca-2E,4E-dieonoic acid isobutylamide (2) showed inhibitory activity on CYP 2C19, 2D6 and 3A4. However, unlike the Echinaforce extract, the alkylamides did not induce CYP 1A2 inhibition. Thus, other, as yet unidentified constituents also contribute to the overall weak inhibitory effects seen with Echinacea preparations in-vitro