Intensive Care Unit-Acquired Weakness – diagnostischer Stellenwert des neuromuskulären Ultraschalls

Die Anaesthesiologie - Die Intensive Care Unit-Acquired Weakness (ICUAW) stellt eine der häufigsten neuromuskulären Komplikationen in der Intensivmedizin dar. Besonders bei...     

Current state of biologic pharmacovigilance in the European Union: improvements are needed

Introduction: Pharmacovigilance is essential to monitoring the safety profiles of authorized medicines. Compared with small-molecule drugs, biological drugs are more complex, more susceptible to structural variability due to manufacturing processes, and have the potential to induce immune-related reactions, underscoring the importance of safety monitoring for these products. Although highly similar to reference products, biosimilars are not expected to be structurally identical. For these reasons, proper reporting of potential adverse drug reactions (ADRs) using distinguishable names and batch numbers is essential for accurate tracing of all biological drugs. To address the need for robust pharmacovigilance, the European Parliament and Council of the European Union provided legislation regarding pharmacovigilance of biologics in 2010.

Areas covered: This narrative review examines the current state of pharmacovigilance for biologics in the European Union (EU) and discusses relevant information on pharmacovigilance of biosimilars, the current EU pharmacovigilance system, and areas that could be improved.

Expert opinion: Although steps have been taken to improve pharmacovigilance of biologics in the EU, several enhancements can still be made, including additional training for healthcare professionals on ADR reporting, the use of 2D barcodes that enhance traceability, and an open discussion of potentially missed opportunities in the pharmacovigilance of biosimilars.     

Collection of Wound Exudate From Human Digit Tip Amputations Does Not Impair Regenerative Healing: A Randomized Trial

The regrowth of amputated digit tips represents a unique regenerative healing in mammals with subcutaneous volume regrowth, restoration of dactylogram, and suppression of scar formation. Although factor analysis in amphibians and even in mice is easy to obtain, safety of harvesting biomaterial from human digit tip amputations for analysis has not yet been described.The aim of this study was to evaluate if recovering wound exudate does hamper clinical outcome or influence microbiologic or inflammation status.A predefined cohort of 18 patients with fresh digit tip amputations was randomly assigned to receive standard therapy (debridement, occlusive dressing) with (n = 9) or without (n = 9) collection of the whole wound exudate in every dressing change. Primary endpoint (lengthening) and secondary endpoints (regeneration of dactylogram, nail bed and bone healing, time to complete wound closure, scar formation, 2-point discrimination, microbiologic analysis, inflammatory factors interleukin (IL)-1α, tumor necrosis factor-α, IL-4, and IL-6) were determined by an independent, blinded observer.Patients’ characteristics showed no significant differences between the groups. All patients completed the study to the end of 3 months follow-up. Exudate collection did not influence primary and secondary endpoints. Furthermore, positive microbiologic findings as well as pus- and necrosis-like appearance neither impaired tissue restoration nor influenced inflammatory factor release.Here, the authors developed an easy and safe protocol for harvesting wound exudate from human digit tip amputations. For the first time, it was shown that harvesting does not impair regenerative healing. Using this method, further studies can be conducted to analyze regeneration associated factors in the human digit tip.DRKS.de Identifier: DRKS00006882 (UTN: U1111-1166-5723).     

Gibt es Unterschiede bei natürlichen Zähnen und Implantaten?

Der Freie Zahnarzt -     

Über die Gewebsspalten der Niere

Ohne ZusammenfassungMit 5 Abbildungen im Text.     

Pedophilia is linked to reduced activation in hypothalamus and lateral prefrontal cortex during visual erotic stimulation.

BACKGROUND: Although pedophilia is of high public concern, little is known about underlying neural mechanisms. Although pedophilic patients are sexually attracted to prepubescent children, they show no sexual interest toward adults. This study aimed to investigate the neural correlates of deficits of sexual and emotional arousal in pedophiles. METHODS: Thirteen pedophilic patients and 14 healthy control subjects were tested for differential neural activity during visual stimulation with emotional and erotic pictures with functional magnetic resonance imaging. RESULTS: Regions showing differential activations during the erotic condition comprised the hypothalamus, the periaqueductal gray, and dorsolateral prefrontal cortex, the latter correlating with a clinical measure. Alterations of emotional processing concerned the amygdala-hippocampus and dorsomedial prefrontal cortex. CONCLUSIONS: Hypothesized regions relevant for processing of erotic stimuli in healthy individuals showed reduced activations during visual erotic stimulation in pedophilic patients. This suggests an impaired recruitment of key structures that might contribute to an altered sexual interest of these patients toward adults.     

Psychiatric patients and their response to experimental stress

Serum levels of Epinephrine (E), norepinephrine (NE), heart rate (HR), skin conductance reaction (SCR) and skin conductance level (SCL) were measured in schizophrenic, endogenous depressed and anxiety patients as well as in normal controls. Conditions were rest, noise and a mental arithmetic (MA) task. Schizophrenic and depressed patients had an attenuated HR response to MA. Moreover, Schizophrenic patients also had higher NE base level and the highest NE secretion during noise. Anxiety and depressed patients showed significantly lower phasic electrodermal activity (SCR) throughout the whole trial, exclusively anxiety patients had significantly higher tonic electrodermal activity (SCL). These findings indicate that autonomous reactions discriminate between patient groups and controls as well as between each other.     

Visual versus computer evaluation of thiopental-induced EEG changes in temporal lobe epilepsy

Thiopental-induced EEG beta activity was analyzed both visually and by computer in 33 patients with complex partial epilepsy. Studies were done in 16 patients with depth electrodes in limbic structures and 17 patients with scalp and sphenoidal electrodes. The percentage of drug-induced change in beta activity was quantified by computer using spectral analysis. The statistical significance of asymmetries between homologous sites in the amount of change was determined. The spatial distribution of significant asymmetries was used for localization and compared with the results of independent visual analysis of the thiopental EEG. Concordance between computer and visual evaluation occurred in 10 of 17 scalp/sphenoidal and 10 of 16 depth electrode tests. The accuracy of visual and computer localization was determined by comparing them with locus of itcal EEG onset, interictal spikes, and positron emission tomography. In scalp/sphenoidal studies, computer analysis indicating asymmetry appeared more likely to correlate with independent clinical criteria than visual analysis. In depth studies the reverse appeared to be true. Scalp/sphenoidal tests yielded positive results in 25-30% of patients whereas depth electrode tests were positive in 50-70% of patients. The results indicate that computer analysis of surface thiopental tests is an accurate and useful supplement to visual evaluation of these tests.