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- ABCB1 C1236T, G2677TA and C3435T genetic polymorphisms and antidepressant response phenotypes: results from a portuguese major depressive disorder cohortPublication . Santos, Marlene; Lima, Luís; Carvalho, Serafim; Brandão, Andreia; Barroso, Fátima; Cruz, Agostinho; Medeiros, RuiP-glycoprotein (P-GP) is a transporter molecule expressed on the apical surface of capillary endothelial cells of the Blood–Brain Barrier (BBB), whose activity heavily influences drug distribution, including antidepressants. This transporter is encoded by ABCB1 gene, and genetic variations within ABCB1 gene have been proposed to affect drug efflux and have been previously associated with depression. In this context, we aimed to evaluate the role of C1236T, G2677TA and C3435T ABCB1 genetic polymorphisms in antidepressant treatment phenotypes from a cohort of patients harboring Major Depressive Disorder. Patients enrolled in the study consisted of 80 individuals with Major Depressive Disorder, who took part in a 27-month follow-up study at HML, Portugal. To investigate the correlation between ABCB1 polymorphisms and antidepressant response phenotypes, DNA was extracted from peripheral blood, and C1236T, C3435T and G2677TA polymorphisms were genotyped with TaqMan® SNP Genotyping Assays. Despite the fact that the evaluated polymorphisms (C1236T, C3435T and G2677TA) were not associated with treatment resistant depression, or relapse, we observed that patients carrying TT genotype of the C3435T polymorphism remit earlier than the ones carrying CC or CT genotypes (10.2 weeks vs. 14.9 and 21.3, respectively, p = 0.028, Log-rank test). Since we found an association with C3435T and time to remission, and not to the absence of remission, we suggest that this polymorphism could have an impact on antidepressant drug distribution, and thus influence on the time to remission will occur, without influencing the risk of remission itself.
- Uma abordagem à avaliação de ambientes virtuais de aprendizagemPublication . Jesus, Ângelo; Gomes, Maria JoãoA avaliação de ambientes de aprendizagem é um tema complexo e multifatorial. No presente trabalho apresenta-se a proposta de avaliação de um ambiente virtual de aprendizagem utilizado para o ensino da farmacoterapia baseado em casos clínicos. Utilizou-se a versão portuguesa reduzida do WEBLEI assim como a Evaluative Assertion Analysis para a recolha de dados. Os resultados obtidos são abonatórios ao nível do acesso aos materiais, interação com os conteúdos e a plataforma, interação com o docente assim como na estruturação e design. Foram reveladas algumas fragilidades nomeadamente ao nível da interação entre estudantes e gestão de tempo. As inferências obtidas serão alvo de reflexão pela equipa de desenvolvimento da UC no processo contínuo de melhoria da iniciativa.
- Acetonitrile adducts of tranexamic acid as sensitive ions for quantification at residue levels in human plasma by UHPLC-MS/MSPublication . Silva, Eduarda M. P.; Barreiros, Luísa; Fernandes, Sara R.; Sá, Paula; Ramalho, João P. Prates; Segundo, Marcela A.The quantitative analysis of pharmaceuticals in biomatrices by liquid chromatography coupled with electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) is often hampered by adduct formation. The use of the molecular ion resulting from solvent adducts for quantification is uncommon, even if formed in high abundance. In this work, we propose the use of a protonated acetonitrile adduct for the quantitative analysis of tranexamic acid (TXA) by LC-MS/MS. The high abundance of the protonated acetonitrile adduct [M + ACN + H]+ was found to be independent of source-dependent parameters and mobile phase composition. The results obtained for TXA analysis in clinical samples were comparable for both [M + ACN + H]+ and [M + H]+ , and no statistically significant differences were observed. The relative stability and structure of the [M + ACN + H]+ ions were also studied by analyzing probable structures from an energetic point of view and by quantum chemical calculations. These findings, and the studied fragmentation pathways, allowed the definition of an acetimidium structure as the best ion to describe the observed acetonitrile protonated adduct of TXA.
- Adaptive design: A review of the technical, statistical, and regulatory aspects of implementation in a clinical trialPublication . Cerqueira, Franck Pires; Jesus, Ângelo; Cotrim, Maria DulceIn an adaptive trial, the researcher may have the option of responding to interim safety and efficacy data in a number of ways, including narrowing the study focus or increasing the number of subjects, balancing treatment allocation or different forms of randomization based on responses of subjects prior to treatment. This research aims at compiling the technical, statistical, and regulatory implications of the employment of adaptive design in a clinical trial. Review of adaptive design clinical trials in Medline, PubMed, EU Clinical Trials Register, and ClinicalTrials.gov. Phase I and seamless phase I/II trials were excluded. We selected variables extracted from trials that included basic study characteristics, adaptive design features, size and use of independent data-monitoring committees (DMCs), and blinded interim analysis. The research retrieved 336 results, from which 78 were selected for analysis. Sixty-seven were published articles, and 11 were guidelines, papers, and regulatory bills. The most prevalent type of adaptation was the seamless phase II/III design 23.1%, followed by adaptive dose progression 19.2%, pick the winner / drop the loser 16.7%, sample size re-estimation 10.3%, change in the study objective 9.0%, adaptive sequential design 9.0%, adaptive randomization 6.4%, biomarker adaptive design 3.8%, and endpoint adaptation 2.6%. It is possible to infer that the use of Adaptive Design is an ethical and scientific advantage when properly planned and applied, since it increases the flexibility of the trial, shortens the overall clinical investigation time of a drug, and reduces the risk of patient exposure to adverse effects related to the experimental drug. Its greater methodologic and analytic complexity requires an adequate statistical methodology. The application of “adaptive clinical designs” for phase II/III studies appear to have been limited to trials with a small number of study centers, with smaller extensions of time and to experimental drugs with more immediate clinical effects that are amenable to risk/benefit decisions based on interim analyses. According to the reviewed studies, simple adaptive trial designs—such as early study terminations due to futility and sample size re-estimation—are becoming widely adopted throughout the pharmaceutical industry, especially in phase II and III studies. The pharmaceutical industry and contract research organizations (CROs) are implementing simple adaptations more frequently and the more complex adaptations—biomarker adaptive design, endpoint adaptation—are more sporadic.
- Allergic rhinitis characterization in community pharmacy customers: a cross-sectional studyPublication . Hélio, Guedes; Morgado, Manuel; Rodrigues, Márcio; Cruz, Agostinho; Fonseca, Cecília; Costa, Elísio; Araújo, André R. T. S.Allergic rhinitis represents a public health problem that is signifcantly prevalent in the global population and has been associated with asthma, a strong desire to sleep and a low quality of life. Objective This study aims to evaluate the prevalence, symptoms, control strategies and treatment, as well as the control of this condition and its impact on the quality of life of customers of community pharmacies with allergic rhinitis.
- Análise da rotulagem de suplementos alimentares utilizados no Sistema Nervoso CentralPublication . Ferreira, Liliana; Cruz, Agostinho; Oliveira, Ana Isabel; Ferraz Oliveira, Rita; Pinho, CláudiaOs suplementos alimentares têm diversos benefícios demonstrados. No entanto, a crença errónea por parte dos consumidores de que estes são isentos de risco e as obrigações legais requeridas para a sua entrada no mercado têm servido de alerta para a necessidade de mais investigação. Analisar, do ponto de vista legal e científico, a informação disponibilizada na rotulagem de suplementos alimentares à base de plantas utilizados para problemas associados ao Sistema Nervoso, comercializados em Portugal. Estudo descritivo, observacional, transversal com a recolha de 44 rótulos de suplementos comercializados em Farmácias Comunitárias e em Ervanárias/Lojas Dietéticas da cidade de Vila Nova de Famalicão, entre julho e agosto de 2019, em formulário próprio. Do ponto de vista legal, a maioria dos SA analisados cumpriu as menções obrigatórias na rotulagem. Do ponto de vista científico, o nome científico das plantas foi a informação que mais frequentemente está presente na rotulagem, com 97,7%. A padronização dos extratos (29,5%), as interações (11,4%) e as reações adversas (11,4%) foram as informações menos mencionadas. Os resultados obtidos realçam a necessidade de uma maior atenção quanto às informações existentes na rotulagem dos suplementos, no sentido de permitir aos consumidores um uso informado e seguro dos produtos.
- Analysis of 17- β -estradiol and 17- α -ethinylestradiol in biological and environmental matrices — A reviewPublication . Barreiros, Luisa; Queiroz, Joana F.; Magalhães, Luís M.; Silva, Adrián M.T.; Segundo, Marcela A.The estrogens 17-β-estradiol (E2) and 17-α-ethinylestradiol (EE2) are reported as highly endocrine-disrupting agents, being recently included in an EU watch list regarding emerging aquatic pollutants. Therefore, the monitoring of these chemicals in the different environmental compartments assumes great importance. Moreover, due to the possible adverse effects on living beings, their occurrence on animal tissues and fluids must also be addressed. In recent years, a significant number of studies have described and proposed different analytical methodologies to detect and/or quantify E2 and EE2 mostly in environmental aqueous samples, including sludge and sediments and also in biological matrices such as plasma and tissues. Taking into account the complexity of real matrices and that both estrogens are generally present at trace levels, the development of accurate and reliable techniques for their determination can be quite a challenge. The present review aims at describing the main characteristics of the analytical methods recently used for E2 and EE2 determination in environmental and biological samples. The steps for sample preparation such as analytes extraction, preconcentration and clean-up are discussed and the instrumental based analytical techniques are compared. Furthermore, the application of biological tools to determine the total estrogenicity of environmental samples, as well as their potential combination with instrumental analyses, is highlighted.
- Analytical methods for quantification of tranexamic acid in biological fluids: A reviewPublication . Silva, Eduarda M.P.; Barreiros, Luisa; Sá, Paula; Afonso, Carlos; Kozek-Langenecker, Sibylle; Segundo, Marcela A.Tranexamic acid (TXA) is a synthetic derivative of the amino acid lysine with antifibrinolytic properties. There is still a lack of pharmacokinetic and pharmacodynamic data concerning variable age groups undergoing surgeries with high blood loss. The optimum dose and administration schedules of TXA are still subject of research, aiming at a safe inhibition of fibrinolysis in the perioperative period. Hence, effective methods for determination of TXA in biological samples are needed. The aim of this review is to discuss the required sample treatment procedures and the analytical methods applied for quantification of TXA, focusing on selected derivatisation agents and internal standards. Methods comprising a separative step (GC, LC or CZE) coupled to spectrophotometric, fluorimetric and mass spectrometry detection were considered, showing a tendency for implementation of MS/MS methods in more recent reports. Detection limits ranging from 0.01 to 0.5 μg mL− 1 in blood plasma were so far attained using LC-MS/MS.
- Anti-inflammatory effect of the antidepressant fluvoxamine – a systematic reviewPublication . Ramalho, A.; Carvalho, R.; Barroso, F.; Cruz, A.; Santos, M.Neuroinflammation corresponds to the immune response of the nervous system to an injury, infection or neurodegenerative disease characterized by the activation of resident glial cells, including microglia and astrocytes, the release of cytokines and chemokines and the activation and migration of leukocytes. Evidence suggests that inflammatory cytokines may be a central factor, affecting multiple neuronal pathways and contributing to the development of depression. Supporting this neuroinflammatory theory, several studies have demonstrated the anti-inflammatory effect of various antidepressant drugs [1]. Fluvoxamine is a selective serotonin uptake inhibitor (SSRIs) used manly in the treatment of depression and anxiety disorders. Recent evidence pointed that a fluvoxamine early treatment on SARS-CoV-2-infected subjets fully prevented COVID-19 symptoms [2]. Thus, it seems relevant to explore the anti-inflammatory mechanism of fluvoxamine.
- Antioxidant Activity and Cytotoxicity of Taraxacum hispanicum Aqueous and Ethanolic Extracts on HepG2 CellsPublication . Laranjeira, C.; Nogueira, A.; Almeida, R.; Oliveira, Ana; Ferraz Oliveira, Rita; Pinho, Cláudia; Cruz, AgostinhoPlants belonging to the genus Taraxacum have been used in traditional medicine. Nowadays, extracts of these plants have been reported for the treatment of diseases, including liver disorders. Increasing interest and research on these plants also revealed its potential for treating cancer. This study aims to evaluate the antioxidant activity and cytotoxic properties of crude extracts from aerial parts of Taraxacum hispanicum H.Lindb, against human hepatocarcinoma (HepG2). Material and methods: Evaluation of the antioxidant properties was performed using DPPH in vitro test, superoxide scavenging assay and Fe2+ chelating activity. MTT assay was used to determine metabolic activity, for 24 and 48 hours.