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Hepatotoxicity of newer antiseizure medications in children: an overview and disproportionality analysis of VigiBase
No full textBackground: We aimed to characterize newer antiseizure medications (ASMs)-induced hepatotoxicity
in children and identify signals of disproportionate reporting of hepatotoxicity-related adverse drug
events (ADEs).
Research Design and Methods: Case reports reported to VigiBase were accessed using Empirica™
Signal software. To summarize characteristics of the retrieved cases, descriptive statistics were used.
A disproportionality analysis was conducted using the Multi-item Gamma Poisson Shrinker algorithm,
which calculates Empirical Bayesian Geometric Mean value and its lower and upper 95% confidence
limits (EB05 and EB95, respectively). EB05 > 2, N > 0 was considered a signal.
Results: Based on 870 analyzed cases, a higher proportion of cases was reported in girls than in boys
and in patients aged 2–11 years than in other age groups. Most cases were serious. In 25 cases,
hepatotoxicity resulted in death. A high proportion of patients (n = 275, 31.61%) experienced hyper-
sensitivity reactions, mostly due to lamotrigine. The disproportionality analysis yielded 17 signals
concerning felbamate, lamotrigine, levetiracetam, oxcarbazepine, stiripentol, and topiramate. Four
signals were for severe liver injury and concerned felbamate, lamotrigine, levetiracetam, and topira-
mate. Gender-biased reporting frequency was detected for four ASM-ADE combinations.
Conclusion: Our results should serve to raise clinicians’ awareness about the potential association
between several newer ASMs and drug-induced liver injury in children
NMDA Receptor Antagonist Memantine Ameliorates Experimental Autoimmune Encephalomyelitis in Aged Rats
Get PDFAging is closely related to the main aspects of multiple sclerosis (MS). The average age of the MS population is increasing and the number of elderly MS patients is expected to increase. In addition to neurons, N-methyl-D-aspartate receptors (NMDARs) are also expressed on non-neuronal cells, such as immune cells. The aim of this study was to investigate the role of NMDARs in experimental autoimmune encephalomyelitis (EAE) in young and aged rats. Memantine, a non-competitive NMDAR antagonist, was administered to young and aged Dark Agouti rats from day 7 after immunization. Antagonizing NMDARs had a more favourable effect on clinical disease, reactivation, and apoptosis of CD4+ T cells in the target organ of aged EAE rats. The expression of the fractalkine receptor CX3CR1 was increased in memantine-treated rats, but to a greater extent in aged rats. Additionally, memantine increased Nrf2 and Nrf2-regulated enzymes’ mRNA expression in brain tissue. The concentrations of superoxide anion radicals, malondialdehyde, and advanced oxidation protein products in brain tissue were consistent with previous results. Overall, our results suggest that NMDARs play a more important role in the pathogenesis of EAE in aged than in young rats
Progress in Topical and Transdermal Drug Delivery Research—Focus on Nanoformulations
Get PDFSkin is the largest organ and a multifunctional interface between the body and its environment. It acts as a barrier against cold, heat, injuries, infections, chemicals, radiations or other exogeneous factors, and it is also known as the mirror of the soul. The skin is involved in body temperature regulation by the storage of fat and water. It is an interesting tissue in regard to the local and transdermal application of active ingredients for prevention or treatment of pathological conditions. Topical and transdermal delivery is an emerging route of drug and cosmetic administration. It is beneficial for avoiding side effects and rapid metabolism. Many pharmaceutical, technological and cosmetic innovations have been described and patented recently in the field. In this review, the main features of skin morphology and physiology are presented and are being followed by the description of classical and novel nanoparticulate dermal and transdermal drug formulations. The biophysical aspects of the penetration of drugs and cosmetics into or across the dermal barrier and their investigation in diffusion chambers, skin-on-a-chip devices, high-throughput measuring systems or with advanced analytical techniques are also shown. The current knowledge about mathematical modeling of skin penetration and the future perspectives are briefly discussed in the end, all also involving nanoparticulated systems
Carbomer Hydrogels with Microencapsulated α-Tocopherol: Focus on the Biocompatibility of the Microcapsules, Topical Application Attributes, and In Vitro Release Study
No full textThe microencapsulation of α-tocopherol based on the complex coacervation of low-molecular-weight chitosan (LMWC) and sodium lauryl ether sulphate (SLES) without harmful crosslinkers can provide biocompatible carriers that protect it from photodegradation and air oxidation. In this study, the influence of the microcapsule wall composition on carrier performance, compatibility with a high-water-content vehicle for topical application, and release of α-tocopherol were investigated. Although the absence of aldehyde crosslinkers decreased the encapsulation efficiency of α-tocopherol (~70%), the variation in the LMWC/SLES mass ratio (2:1 or 1:1) had no significant effect on the moisture content and microcapsule size. The prepared microcapsule-loaded carbomer hydrogels were soft semisolids with pseudoplastic flow behavior. The integrity of microcapsules embedded in the hydrogel was confirmed by light microscopy. The microcapsules reduced the pH, apparent viscosity, and hysteresis area of the hydrogels, while increasing their spreading ability on a flat inert surface and dispersion rate in artificial sweat. The in vitro release of α-tocopherol from crosslinker-free microcapsule-loaded hydrogels was diffusion-controlled. The release profile was influenced by the LMWC/SLES mass ratio, apparent viscosity, type of synthetic membrane, and acceptor medium composition. Better data quality for the model-independent analysis was achieved when a cellulose nitrate membrane and ethyl alcohol 60% w/w as acceptor medium were used
Serbian Version of the eHealth Literacy Questionnaire (eHLQ): Translation, Cultural Adaptation, and Validation Study Among Primary Health Care Users
No full textBackground: As digital health services are increasingly developing and becoming more interactive in Serbia, a comprehensive instrument for measuring eHealth literacy (EHL) is needed. Objective: This study aimed to translate, culturally adapt, and investigate the psychometric properties of the Serbian version of the eHealth Literacy Questionnaire (eHLQ); to evaluate EHL in the population of primary health care (PHC) users in Serbia; and to explore factors associated with their EHL. Methods: The validation study was conducted in 8 PHC centers in the territory of the Mačva district in Western Serbia. A stratified sampling method was used to obtain a representative sample. The Translation Integrity Procedure was followed to adapt the questionnaire to the Serbian language. The psychometric properties of the Serbian version of the eHLQ were analyzed through the examination of factorial structure, internal consistency, and test-retest reliability. Descriptive statistics were calculated to determine participant characteristics. Differences between groups were tested by the 2-tailed Students t test and ANOVA. Univariable and multivariable linear regression analyses were used to determine factors related to EHL. Results: A total of 475 PHC users were enrolled. The mean age was 51.0 (SD 17.3; range 19-94) years, and most participants were female (328/475, 69.1%). Confirmatory factor analysis validated the 7-factor structure of the questionnaire. Values for incremental fit index (0.96) and comparative fit index (0.95) were above the cutoff of ≥0.95. The root mean square error of approximation value of 0.05 was below the suggested value of ≤0.06. Cronbach α of the entire scale was 0.95, indicating excellent scale reliability, with Cronbach α ranging from 0.81 to 0.90 for domains. The intraclass correlation coefficient ranged from 0.63 to 0.82, indicating moderate to good test-retest reliability. The highest EHL mean scores were obtained for the understanding of health concepts and language (mean 2.86, SD 0.32) and feel safe and in control (mean 2.89, SD 0.33) domains. Statistically significant differences (all P<.05) for all 7 eHLQ scores were observed for age, education, perceived material status, perceived health status, searching for health information on the internet, and occupation (except domain 4). In multivariable regression models, searching for health information on the internet and being aged younger than 65 years were associated with higher values of all domain scores except the domain feel safe and in control for variable age. Conclusions: This study demonstrates that the Serbian version of the eHLQ can be a useful tool in the measurement of EHL and in the planning of digital health interventions at the population and individual level due to its strong psychometric properties in the Serbian context
How does the ibuprofen content affect the characteristics of multiparticulate unit systems prepared by selective laser sintering?
No full textSelective laser sintering (SLS) represents a 3D printing technology recently introduced as the drug preparation method (1). It was implemented in the fabrication of different dosage forms, including multiparticulate unit (MPU) systems (2–3).
Up to date, maximal drug content incorporated in the SLS printed dosage forms was 92%, in the case of metronidazole-loaded SLS printed tablets (4). However, in the case of MPUs, the drug load was up to 10% (2–3). Due to the difficulties of incorporating high drug loads into 3D printed dosage forms, the aim of this research was to investigate the possibility of printing multiparticulate unit systems containing higher drug loading and evaluate their characteristics (model drug content, particle size and size distribution, flowability, and drug dissolution)
Karakteristike virusa humane imunodeficijencije-1 koje utiču na razvoj i efikasnost anti-HIV-1 vakcina
No full textUnderstanding the effect of differently charged micelles on the ionization of raloxifene
No full textThe protolytic equilibria of raloxifene were investigated in the presence of differently charged
and/or polar micelles (CTAB, TX-100, Brij 35). The ionization constants were determined
potentiometrically at a constant ionic strength (0.1 M NaCl) and temperature 25°C. In a relation to
the pKa values previously determined in surfactant-free media, the presence of micelles caused a
shift from -3.03 pKa to +3.12 pKa units. Significant changes in distribution of equilibrium forms at
biopharmaceutically important pH values suggest on potential consideration of interactions between
raloxifene and molecules present under the physiological conditions.17th International Conference on Fundamental and Applied Aspects of Physical Chemistry, September 23-27, 2024 Belgrade, Serbi
Lipid status and profile of LDL subfractions in patients with lymphoma
No full textLimfomi su heterogena grupa hematoloških maligniteta, a klasifikuju se kao Hočkinov limfom (HL) i neHočkinov limfom (NHL). Moguća veza između hipoholesterolemije i limfoma kao uzroka ili posledice još
uvek nije utvrđena. Cilj ovog rada je ispitivanje parametara lipidnog statusa i profila LDL subfrakcija kod
pacijenata sa limfomom i njihove povezanosti sa
stadijumom i ishodom bolesti. Studija je uključila 55
pacijenata, od čega 11 sa HL i 44 sa NHL, kao i 33
zdrave osobe, koje su činile kontrolnu grupu (KG).
Koncentracije ukupnog holesterola, triglicerida i
HDL-holesterola su određene standardnim enzimskim metodama, dok je koncentracija LDL-holesterola izračunata primenom Friedwald-ove formule.
Razdvajanje LDL subfrakcija izvršeno metodom vertikalne elektroforeze na gradijent gelu poliakrilamida.
Obe grupe pacijenata su imale značajno niže koncentracije ukupnog i HDL-holesterola u odnosu na
KG. Pacijenati sa HL su imali značajno niže koncentracije LDL-holesterola, kao i niži udeo LDL II subfrakcija, a viši udeo LDL IV subfrakcija u poređenju sa
druge dve grupe ispitanika. Preživeli pacijenti sa NHL
imali su značajno više koncentracije ukupnog i LDL-
holesterola, a manji udeo LDL I subfrakcija. Naši
rezultati ukazuju na izmenjen metabolizam holesterola i potencijalnu ulogu malih LDL čestica u razvoju i
progresiji limfoma, što može biti važna tema budućih
istraživanja.Lymphomas are a heterogeneous group of hemato-
logical malignancies classified as Hodgkin’s lym-
phoma (HL) and non-Hodgkin’s lymphoma (NHL). A
possible association between hypocholesterolemia
and lymphoma as a cause or consequence has not
been established. The aim of this study is to evaluate
the lipid status and LDL subfractions profile in
patients with lymphoma and their association with
disease stage and outcome. The study included 55
patients, 11 with HL and 44 with NHL, and 33
healthy individuals as a control group (CG). Total
cholesterol, triglycerides and HDL cholesterol were
determined using standard enzymatic methods, while
the concentration of LDL-cholesterol was calculated
using the Friedwald formula. LDL subfractions were
separated by vertical polyacrylamide gradient gel
electrophoresis. Both patient groups had significantly
lower concentrations of total and HDL-cholesterol
compared to CG. Patients with HL had significantly
lower concentrations of LDL cholesterol and a lower
proportion of LDL II subfractions, but a higher pro-
portion of LDL IV subfractions compared to the other
two groups. Surviving patients with NHL had signifi-
cantly higher concentrations of total and LDL-choles-
terol and a lower proportion of LDL I subfractions.
Our results point to altered cholesterol metabolism
and the potential role of small LDL particles in the
development and progression of lymphoma, which
may be an important topic for future research.Međunarodni XXIII srpski kongres medicinske biohemije i laboratorijske medicine, 16-18. septembar 2024. godine, Posterske sekcij
Assessment of medication literacy of anticoagulation therapy in hospitalized orthopedic patients
No full textBackground Risk of venous thromboembolism (VTE) in patients undergoing major orthopedic surgery is high, therefore low-molecular-weight heparins (LMWHs), fondaparinux or adjusted-dose warfarin are preferred options for VTE prophylaxis. ..