Browsing by Author "Carvalho, S"
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- Análise económica do rituximab, em associação com ciclofosfamida, vincristina e prednisolona no tratamento de doentes com linfoma folicular avançado em PortugalPublication . Braga, P; Carvalho, S; Gomes, M; Guerra, L; Lúcio, P; Marques, H; Negreiro, F; Pereira, C; Silva, C; Teixeira, AOBJECTIVE: Evaluate costs and benefits of rituximab in combination with cyclophosphamide/vincristine/prednisolone chemotherapy regimen (R-CVP), in previously untreated patients with indolent non-Hodgkin lymphoma (NHL), compared to CVP alone from a Portuguese National Health System (NHS) perspective. METHODS: Cost-effectiveness (Life Years Gained--LYG) and cost-utility analysis (Quality Adjusted Life Years--QALYs) were performed for a time horizon of 10 years, according to a Markov economic model with three health states (progression free survival, progression and death) and monthly cycles for a population of previously untreated patients with indolent NHL. Data from a phase III clinical trial was used and expanded to include unpublished 53-month median follow-up data. Survival after first-line therapy was estimated from the Scotland and Newcastle Lymphoma Group registry data and utilities were derived from a study in the UK performed in patients with follicular lymphoma. Resource consumption was estimated by a Portuguese expert panel (Delbecq Panel). Costs were calculated from the Portuguese NHS perspective through official data with prices updated to 2008. Only direct medical costs were considered. Costs and clinical outcomes were discounted at 5% per annum. Deterministic and probabilistic sensitivity analysis were performed around assumptions on the time horizon, costs, utilities and excess mortality rate due to progression applied in the base-case analysis. RESULTS: The 10-year base-case analysis showed a lower total cost per patient with CVP alone (€ 85,838) in comparison with R-CVP (€ 87,774). Life expectancy and Quality adjusted life expectancy per patient were higher with R-CVP (6.361 and 4.166, respectively) than with CVP alone (5.557 and 3.438, respectively), representing increases of 0.804 in LYG and 0.728 (8.7 months) in QALYs gained. The incremental cost per LYG was € 2,407 and the incremental cost per QALY gained was € 2,661. The probabilistic sensitivity analysis confirmed the robustness of the base-case analysis results. CONCLUSIONS: This study demonstrates that the combination R-CVP in previously untreated indolent NHL patients improves life expectancy and is a cost-effective alternative to CVP in Portugal.
- El síndrome de Mauriac todavía existePublication . Dias, J; Martins, S; Carvalho, S; Marques, O; Antunes, ABACKGROUND/OBJECTIVE: Mauriac syndrome (MS) is a rare complication of type 1 diabetes mellitus (DM1). It is related to low insulin concentrations and is less common since longer-acting insulins became available. It is characterized by hepatomegaly, growth and puberty delay, and the presence of elevated transaminases and serum lipids. The aim of this study was to describe the patients from a pediatric diabetic population that fulfill the criteria of MS. MATERIALS AND METHODS: A retrospective analysis of the pediatric diabetic population with diagnostic criteria of MS currently followed at Hospital de Braga, was performed. RESULTS: From a population of 91 patients with DM1 18 years, 6 patients with the criteria for MS were identified: 5 girls, and 1 boy. The age at presentation was 13-17 years, with a minimum interval between DM1 diagnosis and MS criteria of 4 years. All the patients were prescribed intensive insulin therapy (median daily insulin dose: 0.88U/kg). All had a previous history of poor glycemic control before the diagnosis of MS with glycated hemoglobin (HbA1c) between 8.8 and 12.9%. Increase of hepatic enzymes was present in all the patients; 4 of them had associated hepatomegaly. All the girls presented puberty delay and cushingoid features. None of the patients presented short stature and 5 of them presented mixed dyslipidemia. CONCLUSIONS: Although MS is an ancient entity described in DM1, it still exists, particularly in adolescent females. Being aware of MS is of extreme importance since most of the clinical features are reversible with better glycemic control.
- Implantable Cardioverter-Defibrillators in Trials of Drug Therapy for Heart Failure: A Systematic Review and Meta-AnalysisPublication . Gama, F; Ferreira, J; Carmo, J; Costa, FM; Carvalho, S; Carmo, P; Cavaco, D; Morgado, FB; Adragão, P; Mendes, MBACKGROUND Medical therapy for heart failure with reduced ejection fraction evolved since trials validated the use of implantable cardioverter-defibrillators (ICDs). We sought to evaluate the performance of ICDs in reducing mortality in the era of modern medical therapy by means of a systematic review and meta-analysis of contemporary randomized clinical trials of drug therapy for heart failure with reduced ejection fraction. METHODS AND RESULTS We systematically identified randomized clinical trials that evaluated drug therapy in patients with heart failure with reduced ejection fraction that reported mortality. Studies that enrolled <1000 patients, patients with left ventricular ejection fraction >40%, or patients in the acute phase of heart failure and study treatment with devices were excluded. We identified 8 randomized clinical trials, including 31 701 patients of whom 3631 (11.5%) had an ICD. ICDs were associated with a lower risk of all-cause mortality (relative risk [RR], 0.85; 95% CI, 0.78-0.94) and sudden cardiac death (RR, 0.49; 95% CI, 0.40-0.61). Results were consistent among studies published before and after 2010. In meta-regression analysis, the proportion of nonischemic etiology did not affect the associated benefit of ICD. CONCLUSIONS In our meta-analysis of contemporary randomized trials of drug therapy for heart failure with reduced ejection fraction, the rate of ICD use was low and associated with a decreased risk in both all-cause mortality and sudden cardiac death. This benefit was still present in trials with new medical therapy.
- Mauriac syndrome still existsPublication . Dias, J; Martins, S; Carvalho, S; Marques, O; Antunes, ABACKGROUND/OBJECTIVE: Mauriac syndrome (MS) is a rare complication of type 1 diabetes mellitus (DM1). It is related to low insulin concentrations and is less common since longer-acting insulins became available. It is characterized by hepatomegaly, growth and puberty delay, and the presence of elevated transaminases and serum lipids. The aim of this study was to describe the patients from a pediatric diabetic population that fulfill the criteria of MS. MATERIALS AND METHODS: A retrospective analysis of the pediatric diabetic population with diagnostic criteria of MS currently followed at Hospital de Braga, was performed. RESULTS: From a population of 91 patients with DM1 18 years, 6 patients with the criteria for MS were identified: 5 girls, and 1 boy. The age at presentation was 13-17 years, with a minimum interval between DM1 diagnosis and MS criteria of 4 years. All the patients were prescribed intensive insulin therapy (median daily insulin dose: 0.88 U/kg). All had a previous history of poor glycemic control before the diagnosis of MS with glycated hemoglobin (HbA1c) between 8.8 and 12.9%. Increase of hepatic enzymes was present in all the patients; 4 of them had associated hepatomegaly. All the girls presented puberty delay and cushingoid features. None of the patients presented short stature and 5 of them presented mixed dyslipidemia. CONCLUSIONS: Although MS is an ancient entity described in DM1, it still exists, particularly in adolescent females. Being aware of MS is of extreme importance since most of the clinical features are reversible with better glycemic control.
- Patterns of Default Mode Network Deactivation in Obsessive Compulsive DisorderPublication . Gonçalves, ÓF; Soares, JM; Carvalho, S; Leite, J; Ganho-Ávila, A; Fernandes-Gonçalves, A; Pocinho, F; Carracedo, A; Sampaio, AThe objective of the present study was to research the patterns of Default Mode Network (DMN) deactivation in Obsessive Compulsive Disorder (OCD) in the transition between a resting and a non-rest emotional condition. Twenty-seven participants, 15 diagnosed with OCD and 12 healthy controls (HC), underwent a functional neuroimaging paradigm in which DMN brain activation in a resting condition was contrasted with activity during a non-rest condition consisting in the presentation of emotionally pleasant and unpleasant images. Results showed that HC, when compared with OCD, had a significant deactivation in two anterior nodes of the DMN (medial frontal and superior frontal) in the non-rest pleasant stimuli condition. Additional analysis for the whole brain, contrasting the resting condition with all the non-rest conditions grouped together, showed that, compared with OCD, HC had a significantly deactivation of a widespread brain network (superior frontal, insula, middle and superior temporal, putamen, lingual, cuneus, and cerebellum). Concluding, the present study found that OCD patients had difficulties with the deactivation of DMN even when the non-rest condition includes the presentation of emotional provoking stimuli, particularly evident for images with pleasant content.
- Serum leptin levels in overweight children and adolescentsPublication . Antunes, H; Santos, C; Carvalho, SLeptin is an adipocyte-secreted hormone which plays a key role in energy homeostasis. Our aim was to determine the relationship between serum leptin and clinical and biochemical features in overweight children and adolescents. Overweight children and adolescents followed in this Unit with serum leptin ascertained were included. Clinical, biochemical and abdominal ultrasound data were analysed. Statistical analysis was performed by t test, chi2, Pearson's correlation and linear regression. One outlier of serum leptin was excluded to perform correlation and regression. Serum leptin was determined in 357 patients. At the first visit, the mean age was 9.5 (sd 3.2) years and mean BMI z-score was 1.72 (sd 1.34) (girls 1.71 (sd 1.16); boys 1.72 (sd 1.11)). Serum leptin levels were significantly related to: sex (mean: girls 48.0 ng/ml, boys 34.4 ng/ml; P = 0.003); Tanner stage (mean: I-II 37.0 ng/ml, III-V 45.2 ng/ml; P = 0.035); systolic blood pressure (mean: normal 41.3 ng/ml, high 44.0 ng/ml; P = 0.009); BMI z-score (r 0.136; P = 0.010); C-peptide (r 0.17; P = 0.002); insulin (r 0.34; P < 0.001); homeostasis model assessment of insulin resistance (HOMA-IR) (r 0.25; P < 0.001) and aspartate aminotransferase (r - 0.12; P = 0.023). In the multivariate analysis (with leptin as the dependent variable and sex, Tanner stage, BMI z-score, systolic blood pressure, aspartate aminotransferase, C-peptide, insulin and HOMA-IR as independent variables), sex and BMI were determinant factors. The present study in overweight children and adolescents showed that being female and greater BMI were significantly and independently associated with increased serum leptin. In this large cohort other associations with leptin described in the literature can be discharged.
- Transcranial Direct Current Stimulation as an Add-on Treatment to Cognitive-Behavior Therapy in First Episode Drug-Naïve Major Depression Patients: The ESAP Study ProtocolPublication . Carvalho, S; Gonçalves, ÓF; Brunoni, AR; Fernandes-Gonçalves, A; Fregni, F; Leite, JBackground: Major Depressive Disorder (MDD) affects more than 264 million people worldwide. Current treatments include the use of psychotherapy and/or drugs, however ~30% of patients either do not respond to these treatments, or do not tolerate the side effects associated to the use of pharmacological interventions. Thus, it is important to study non-pharmacological interventions targeting mechanisms not directly involved with the regulation of neurotransmitters. Several studies demonstrated that transcranial Direct Current Stimulation (tDCS) can be effective for symptoms relief in MDD. However, tDCS seems to have a better effect when used as an add-on treatment to other interventions. Methods/Design: This is a study protocol for a parallel, randomized, triple-blind, sham-controlled clinical trial in which a total of 90 drug-naïve, first-episode MDD patients (45 per arm) will be randomized to one of two groups to receive a 6-weeks of CBT combined with either active or sham tDCS to the dorsolateral prefrontal cortex (DLPFC). The primary outcome will depressive symptoms improvement as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) at 6-weeks. The secondary aim is to test whether CBT combined with tDCS can engage the proposed mechanistic target of restoring the prefrontal imbalance and connectivity through the bilateral modulation of the DLPFC, as assessed by changes over resting-state and emotional task eliciting EEG. Discussion: This study evaluates the synergetic clinical effects of CBT and tDCS in the first episode, drug-naïve, patients with MDD. First episode MDD patients provide an interesting opportunity, as their brains were not changed by the pharmacological treatments, by the time course, or by the recurrence of MDD episodes (and other comorbidities). Trial Registration: This study is registered with the United States National Library of Medicine Clinical Trials Registry (NCT03548545). Registered June 7, 2018, clinicaltrials.gov/ct2/show/NCT03548545. Protocol Version 1.
- Valores locais normais: deverão ser incluídos no controlo de qualidade dos Laboratórios de Função Respiratória?Publication . Carvalho, S; Rosa, PA interpretação dos valores funcionais obtidos por espirometria depende da comparação destes com valores ditos de referência ou previstos. Estes valores de referência derivam de equações construídas a partir de uma amostra de indivíduos considerados normais. Ora esta normalidade relaciona-se com as características próprias de cada população e, provavelmente, com a época em que esses valores de normalidade foram obtidos. As equações de referência mais utilizadas na Europa foram estabelecidas pela Comunidade Europeia do Carvão e do Aço (CECA) em 1983. Importa perceber se essas equações de referência refletem ou se ainda refletem, a normalidade da população portuguesa. Pretende-se comparar a FVC e FEV1 observados numa população “saudável” e não fumadora de Vila Franca de Xira (VFX) com os previstos pelas equações de referência da CECA. Em Vila Franca de Xira (VFX) recolhemos entre 14 de maio e 4 de agosto de 2016 uma amostra de 64 voluntários adultos (44 mulheres), idades 26-82 anos, não fumadores, sem sintomatologia e patologia respiratória e comparámo-la com os valores previstos pela CECA. Teste-T para amostras emparelhadas foi usado para fazer esta comparação. Foi considerado um nível de significância de 5%. Encontrámos diferenças significativas nas mulheres, sobrevalorizando a FVC (3.29±0.523) em 336 ml e subvalorizando o FEV1 (2.76±0.567) em 182 ml. Nos homens registou-se uma subvalorização da FVC (4.55±0.948) em 124ml e do FEV1 (3.71±0.779) em 82ml, mas sem significado estatístico. Concluímos assim, que as equações da CECA poderão não estar ajustadas às mulheres da nossa população, o que a ser verdade pode ter implicações clínicas importantes, como por exemplo o subdiagnóstico da DPOC nas mulheres.A pergunta que fica é pois, se o conhecimento atualizado dos valores espirométricos normais de cada população deve ser incluído no controlo de qualidade dos Laboratórios de Função Respiratória