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1.
Arq. ciências saúde UNIPAR ; 27(2): 574-592, Maio-Ago. 2023.
Artigo em Português | LILACS | ID: biblio-1419211

RESUMO

A pandemia pelo SARS-CoV-2 é um dos maiores desafios sanitários em escala global. Devido estado de emergência, uma série de medidas de controle e prevenção foram adotadas, como distanciamento social e redução das reuniões públicas. Nesse cenário, buscou-se avaliar a saúde mental de estudantes de uma instituição privada de Ensino Superior diante da pandemia. Esta pesquisa trata-se de um estudo transversal descritivo desenvolvido na Faculdade do Vale do Jaguaribe, localizada em Aracati-CE. A coleta de dados ocorreu de dezembro de 2020 a fevereiro de 2021, utilizando formulário eletrônico contendo variáveis sociodemográficas, epidemiológicas e relativas aos diferentes aspectos da saúde mental do estudante frente a pandemia da COVID-19. A análise foi baseada no cálculo de frequências absolutas e relativas das variáveis além de medidas de tendência central e dispersão. Dos 333 discentes que participaram do estudo, a média de idade foi 25, com variação entre 18 e 56 anos, sendo maioria do sexo feminino (72,7%), autodenominação de cor/etnia parda (72,7%) e não estarem trabalhando (53,8%). A taxa de positividade entre os graduandos para COVID-19 foi de 9% (30). Ao serem questionados sobre como a pandemia alterou seus níveis de estresse ou saúde mental, 75,5% responderam que houve piora. Dentre os sintomas mais relatados no período da quarentena, estavam medo e ansiedade (ambos com 74,2%), seguidos por insegurança (69,7%). Baseados nos achados deste estudo, recomenda-se a incorporação de ações multiprofissionais na atenção aos estudantes dentro da academia. Sugere-se a implantação de um serviço qualificado buscando desenvolver um olhar holístico para os discentes.


The SARS-CoV-2 pandemic has presented itself as one of the greatest health challenges on a global scale. Given the state of public health emergency, a series of control and prevention measures have been adopted, such as social distancing and reduction of public meetings, as in universities. Faced with this scenario, we sought to evaluate the mental health of students from a private institution of Higher Education in the face of the COVID-19 pandemic. Thus, this research was a descriptive cross-sectional study developed at the Faculdade do Vale do Jaguaribe, located in the City of Aracati- CE. Data collection occurred from December 2020 to February 2021, using an electronic form containing sociodemographic and epidemiological variables, as well as variables related to the repercussions in different aspects of the student's mental health when facing the pandemic of COVID-19. The analysis was based on the calculation of absolute and relative frequencies of the variables, as well as measures of central tendency and dispersion. Of the 333 students who participated in the study, the mean age was 25 years, with ages ranging from 18 to 56 years, the majority being female (72.7%), self- denominated as Brown (72.7%), not working when answering the form (53.8%). The positivity rate among undergraduates for COVID-19 was 9% (30/333). When asked how the pandemic altered their stress levels or mental health, 75.5% responded that it had worsened. Among the symptoms most reported by students during the quarantine period were fear and anxiety (both 74.2%), followed by insecurity (69.7%). It is suggested the implementation of a qualified approach service seeking to develop a holistic look for the students.


La pandemia por SARS-CoV-2 es uno de los mayores desafíos sanitarios a escala global. Debido al estado de emergencia, se han adoptado una serie de medidas de control y prevención, como el distanciamiento social y la reducción de reuniones públicas. En este escenario, se buscó evaluar la salud mental de los estudiantes de una institución privada de educación superior frente a la pandemia. Esta investigación es un estudio descriptivo transversal desarrollado en la Facultad de Valle de Jaguaribe, ubicada en Aracati-CE. La recopilación de datos se llevó a cabo de diciembre de 2020 a febrero de 2021, utilizando un formulario electrónico que contiene variables sociodemográficas, epidemiológicas y relacionadas con los diferentes aspectos de la salud mental del estudiante frente a la pandemia de COVID-19. El análisis se basó en el cálculo de frecuencias absolutas y relativas de las variables, además de medidas de tendencia central y dispersión. De los 333 estudiantes que participaron en el estudio, la media de edad fue de 25 años, con variación entre 18 y 56 años, siendo la mayoría del sexo femenino (72,7%), autodenominación de la raza / etnia morena (72,7%) y no trabajando (53,8%). La tasa de positividad entre los estudiantes de pregrado para COVID-19 fue del 9% (30). Cuando se les preguntó cómo la pandemia había alterado su nivel de estrés o salud mental, el 75,5% respondió que había empeorado. Entre los síntomas más comunes durante el período de cuarentena, se encontraban el miedo y la ansiedad (ambos con un 74,2%), seguidos de la inseguridad (69,7%). Basados en los resultados de este estudio, se recomienda la incorporación de acciones multiprofesionales en la atención a los estudiantes dentro de la academia. Se sugiere la implementación de un servicio calificado que busque desarrollar una mirada holística hacia los estudiantes.


Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Estudantes , Universidades , Saúde Mental/educação , Pandemias , COVID-19/epidemiologia , Ansiedade , Estresse Fisiológico , Estudos Transversais/métodos , Academias e Institutos , Estudos Observacionais como Assunto/métodos , Medo , Distanciamento Físico , Fatores Sociodemográficos , Pesquisa sobre Serviços de Saúde
2.
Curr Pain Headache Rep ; 25(3): 15, 2021 Feb 25.
Artigo em Inglês | MEDLINE | ID: mdl-33630186

RESUMO

PURPOSE OF REVIEW: This manuscript is a systematic, narrative review that compiles and describes all data available from 2019 related to epidemiologic, diagnostic, and therapeutic advances in diabetic neuropathy (DN). RECENT FINDINGS: Epidemiology of DN is discussed. Diagnostic modalities include predictive models, electrodiagnostics, imaging, and biomarkers. A majority of studies on the treatment of diabetic peripheral neuropathy (DPN) involve pharmacotherapy, but complementary and alternative medicine, exercise, modalities, psychological, interventional, and surgical options are also explored. DN is a highly prevalent and debilitating consequence of diabetes that can present challenges to the clinician as the assessment is largely subjective with different phenotypic presentations among patients. Treatment of DN is largely symptomatic as the pathogenesis of DN is not fully understood and is likely multifactorial. It is evident from the broad range of treatments that too often provide unsatisfactory relief that there is no consensus about a single most effective treatment for DN, and monotherapy rarely proves to be successful.


Assuntos
Análise de Dados , Neuropatias Diabéticas/sangue , Neuropatias Diabéticas/terapia , Analgésicos/uso terapêutico , Biomarcadores/sangue , Neuropatias Diabéticas/diagnóstico , Eletrodiagnóstico/métodos , Humanos , Mediadores da Inflamação/sangue , Condução Nervosa/fisiologia , Estudos Observacionais como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
3.
Anesth Analg ; 132(1): 100-107, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32947294

RESUMO

BACKGROUND: Retrograde autologous priming (RAP) before cardiopulmonary bypass (CPB) may minimize allogeneic red cell transfusion. We conducted a systematic review of the literature to examine the impact of RAP on perioperative allogeneic red cell transfusions in cardiac surgical patients. METHODS: This study involved a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies evaluating the use of RAP in cardiac surgery involving CPB. The primary outcome was intraoperative allogeneic red cell transfusion. Secondary outcomes included whole hospital allogeneic transfusions and adverse events such as acute kidney injury (AKI) and stroke. RESULTS: A total of 11 RCTs (n = 1337 patients) were included, comparing RAP patients (n = 674) to control (n = 663). In addition, 10 observational studies (n = 2327) were included, comparing RAP patients (n = 1257) to control (n = 1070). Overall, RAP was associated with a significantly reduced incidence of intraoperative red cell transfusion (n = 18 studies; odds ratio [OR] = 0.34; 95% confidence interval [CI], 0.22-0.55, P < .001) compared to controls. This effect was seen among RCTs (n = 10 studies; OR = 0.19; 95% CI, 0.08-0.45, P < .001) and observational studies (n = 8 studies; OR = 0.66; 95% CI, 0.50-0.87, P = .004) in isolation. RAP was also associated with a significantly reduced incidence of whole hospital red cell transfusion (n = 5 studies; OR = 0.28; 95% CI, 0.19-0.41, P < .001). Among the studies that reported AKI and stroke outcomes, there was no statistically significant increased odds of AKI or stroke in either RAP or control patients. CONCLUSIONS: Based on the pooled results of the available literature, RAP is associated with a significant reduction in intraoperative and whole hospital allogeneic red cell transfusion. Use of RAP may prevent hemodilution of cardiac surgical patients and thus, lessen transfusions. Additional high-quality prospective studies are necessary to determine the ideal priming volume necessary to confer the greatest benefit without incurring organ injury.


Assuntos
Transfusão de Sangue Autóloga/métodos , Transfusão de Sangue Autóloga/tendências , Ponte Cardiopulmonar/tendências , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/tendências , Ponte Cardiopulmonar/efeitos adversos , Humanos , Estudos Observacionais como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
5.
BMC Urol ; 20(1): 58, 2020 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-32460741

RESUMO

BACKGROUND: Posterior tibial nerve stimulation (PTNS) is a promising treatment for lower urinary tract symptoms (LUTS) in patients with MS. However, long term data focusing on PTNS impact on health-related quality of life (HRQOL), bowel and bladder symptoms are lacking. This paper describes a study protocol that examines the extended efficacy of PTNS on MS related bladder and bowel symptoms and resulting HRQOL. METHODS/DESIGN: This is a single-centered, prospective, longitudinal, observational cohort study of patients with MS who suffer from LUTS and are refractory to two prior treatment modalities. Participants who have elected to pursue PTNS therapy for LUTS will be eligible. The primary outcome is the median number of urinary frequency and incontinence episodes on a 3-day voiding diary at 3, 12 and 24 months compared to baseline. Secondary outcome measures will include change in total AUA-SS, M-ISI, NBSS, SF-12, SSS and BCS scores from baseline The Expanded Disability Status Scale and magnetic resonance imaging will be evaluated at baseline and annually throughout the study. DISCUSSION: This research protocol aims to expand on the existing literature regarding outcomes of PTNS in MS. Specifically, it will provide long term follow-up data on bladder, bowel, sexual and HRQOL outcomes. The completion of this study will provide longitudinal efficacy data of the impact of PTNS in MS patients. TRIAL REGISTRATION: NCT04063852.


Assuntos
Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/terapia , Esclerose Múltipla/complicações , Qualidade de Vida , Estimulação Elétrica Nervosa Transcutânea , Estudos de Coortes , Humanos , Estudos Longitudinais , Estudos Observacionais como Assunto/métodos , Estudos Prospectivos , Projetos de Pesquisa , Nervo Tibial
6.
Dig Dis Sci ; 65(3): 885-896, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32067144

RESUMO

With the advent of next-generation sequencing approaches, there has been a renaissance in the microbiome field. Microbial taxonomy and function can now be characterized relatively easily and rapidly-no longer mandating complex culturing approaches. With this renaissance, there is now a strong and growing appreciation for the role of the microbiome (referring to microbes and their genomes) in modulating many facets of physiology-including overall immunity. This is particularly true of the gut microbiome, and there is now an evolving body of the literature demonstrating a role for gut microbes in modulating responses to cancer treatment-particularly immunotherapy. Gut microbes can modulate immunity and anti-tumor responses via a number of different interactions, and these will be discussed herein. Additionally, data regarding the impact of gut microbes on cancer immunotherapy response will be discussed, as will strategies to manipulate the microbiome to enhance therapeutic responses. These efforts to date are not completely optimized; however, there is evidence of efficacy though much additional work is needed in this space. Nonetheless, it is clear that the microbiome plays a central role in health and disease, and strategies to manipulate it in cancer and overall precision health are being explored.


Assuntos
Antineoplásicos Imunológicos/imunologia , Antineoplásicos Imunológicos/uso terapêutico , Microbioma Gastrointestinal/imunologia , Imunoterapia/tendências , Neoplasias/tratamento farmacológico , Neoplasias/imunologia , Animais , Antineoplásicos Imunológicos/farmacologia , Avaliação Pré-Clínica de Medicamentos/métodos , Microbioma Gastrointestinal/efeitos dos fármacos , Humanos , Imunoterapia/métodos , Neoplasias/microbiologia , Estudos Observacionais como Assunto/métodos
7.
Epilepsy Behav ; 102: 106635, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31731110

RESUMO

This paper aimed to systematically examine the efficacy and adverse event (AE) profile of cannabidiol and medicinal cannabis by analyzing qualitative and meta-analytic data. We used the terms ("Cannabidiol" OR "Cannabis") AND "Epilepsy" AND ("Treatment" OR "Therapeutics") as keywords to retrieve studies indexed on PubMed, ScienceDirect, and CENTRAL databases. The inclusion criteria were as follows: clinical studies with a longitudinal observational design and intervention using cannabinoid derivatives, especially cannabidiol and medicinal cannabis, whereby some results involved the frequency of epileptic seizures. We used Cochrane Collaboration's Review Manager software (RevMan 5.1.6) for the meta-analysis and dichotomized the articles to a confidence interval of 95%. From 236 articles, we selected 16 for descriptive analysis; we selected only 4 for the meta-analysis. According to the results, a statistically meaningful effect of cannabidiol compared with placebo was observed (p < 0.00001). When comparing treatment with cannabidiol or medicinal cannabis, significance was not found for the AE profile (p = 0.74). As AEs for cannabidiol were more common under short-term than under long-term treatment (p < 0.00001), this approach was favorable in the long term. Furthermore, cannabidiol is more effective than placebo, regardless of the etiology of epileptic syndromes and dosage. Overall, the AE profile did not differ across treatments with cannabidiol or medicinal cannabis, though it did differ favorably for long-term than for short-term treatment.


Assuntos
Anticonvulsivantes/uso terapêutico , Canabidiol/uso terapêutico , Epilepsia Resistente a Medicamentos/diagnóstico , Epilepsia Resistente a Medicamentos/tratamento farmacológico , Maconha Medicinal/uso terapêutico , Anticonvulsivantes/efeitos adversos , Canabidiol/efeitos adversos , Humanos , Estudos Longitudinais , Maconha Medicinal/efeitos adversos , Estudos Observacionais como Assunto/métodos , Resultado do Tratamento
8.
BMJ Open ; 9(11): e032113, 2019 11 12.
Artigo em Inglês | MEDLINE | ID: mdl-31722951

RESUMO

INTRODUCTION: Temporomandibular disorders (TMDs) are principally characterised by pain in the craniomandibular area and probable limitations of jaw opening. Manual therapy, like other recommended conservative treatments included in clinical guidelines, is commonly used to treat patients with TMD to reduce pain and improve function. However, outcomes may be variable. The aim of this study is to identify predictors associated with pain reduction in patients with TMD following manual therapy by analysing a combination of patient-reported outcome measures and clinical tests. Such knowledge will support a more personalised management approach by facilitating clinical decision-making. METHODS/ANALYSIS: An observational prospective design will recruit a cohort of 100 adults with a diagnosis of TMD (according to Axis I of the Diagnostic Criteria for TMD) at a Dental Hospital in Italy. Patients will be treated with four weekly sessions of manual therapy applied to craniomandibular structures. An array of predictors has been chosen based on previous research on prognostic factors for TMD and altered pain modulation in musculoskeletal disorders. Candidate predictors including demographic variables, general health variables, psychosocial features, TMD characteristics and clinical tests of the temporomandibular joint and masticatory muscles will be collected at baseline. Definition of good outcome is a clinically significant reduction of pain intensity over the last week (≥30% reduction Visual Analogue Scale) immediately following the four week intervention. Exploratory factor analysis will be applied to analyse factor loading of candidate predictors for good outcome at four weeks. Subsequently, a logistic multivariable regression model will be performed to calculate low and high risk of good outcome. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the 'Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico' and University of Birmingham Ethics Committee. The results will be submitted for publication in a peer-reviewed journal and presented at conferences. TRIAL REGISTRATION NUMBER: NCT03990662; Pre-results.


Assuntos
Manipulações Musculoesqueléticas , Estudos Observacionais como Assunto/métodos , Manejo da Dor/métodos , Dor/etiologia , Projetos de Pesquisa , Transtornos da Articulação Temporomandibular/complicações , Transtornos da Articulação Temporomandibular/terapia , Humanos , Prognóstico , Estudos Prospectivos , Resultado do Tratamento
9.
Psychiatry Res ; 280: 112523, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31450032

RESUMO

Whilst the effects of cannabis preceding psychosis onset are well established, an effect post-onset is less clear. Emerging evidence suggests that cannabis use is associated with increased relapse outcomes possibly because of determinants, antipsychotic treatment failure and medication adherence, that are not mutually exclusive. Due to the paucity of literature on antipsychotic treatment failure an association with cannabis remains conjectural. This review sought to summarise current evidence regarding the effect of cannabis use on antipsychotic treatment failure among users and non-users with psychosis. Ovid databases (Embase, Journals@Ovid Full Text, OvidMEDLINE® In-Process and Other Non-Indexed Citations and PsycINFO) were searched to identify relevant articles. Seven articles met eligibility criteria. Cannabis use was associated with the following deleterious outcomes increased: odds of non-remission, prescription of unique antipsychotic medications, cumulative prescription of Clozapine and poor treatment trajectories. One study reported similar life-time, but lower past-year, rates of cannabis use in those prescribed Clozapine. Another study reported differences between groups for chlorpromazine equivalent doses for long-term Olanzapine prescription. Improved methodologies are warranted due to a lack of well-designed prospective studies and heterogeneity of key variables. There remains, despite research paucity, the need to encourage early cannabis cessation and higher-quality research to inform clinical practice.


Assuntos
Antipsicóticos/uso terapêutico , Fumar Maconha/tratamento farmacológico , Fumar Maconha/psicologia , Transtornos Psicóticos/tratamento farmacológico , Transtornos Psicóticos/psicologia , Adulto , Estudos de Casos e Controles , Comorbidade , Feminino , Humanos , Masculino , Abuso de Maconha/tratamento farmacológico , Abuso de Maconha/epidemiologia , Abuso de Maconha/psicologia , Fumar Maconha/epidemiologia , Adesão à Medicação , Estudos Observacionais como Assunto/métodos , Estudos Prospectivos , Transtornos Psicóticos/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Falha de Tratamento
10.
BMJ Open ; 9(3): e025944, 2019 03 23.
Artigo em Inglês | MEDLINE | ID: mdl-30904869

RESUMO

INTRODUCTION: Preoperative radiotherapy followed by total mesorectal excision with adjuvant chemotherapy has been recommended as the preferred treatment method for locally advanced rectal cancer (LARC). Similar rates of local control, survival and toxicity were observed in preoperative long-course chemoradiotherapy (LCRT) (45-50.4 Gy in 25-28 fractions) and in short-course radiotherapy (SCRT) with 25 Gy over five fractions. Both regimens lower the local recurrence rates compared with that of surgery followed by postoperative radiotherapy. With the simplicity and lower cost of SCRT, a growing number of patients have been receiving SCRT as preoperative radiotherapy. However, the currently established SCRT (25 Gy over five fractions) followed immediately by surgery resulted in poor downstaging and sphincter preservation rate. The pathological complete response (pCR) rate is also markedly lower with SCRT than with LCRT (0.7%vs16%). Several studies recommended SCRT with delayed surgery for more than 4 weeks with expectation of improved pathological outcomes and fewer postoperative complications. While a number of clinical trials demonstrated a persistently better overall local control with SCRT than with LCRT, overall survival advantage has not been observed. Since survival is mainly depended on distant metastases, efforts should be made towards more effective pathological response and systemic treatment. Given the apparent advantages of SCRT, we aimed to establish a dose escalation of SCRT and sequential modified FOLFOX6 (mFOLFOX6) as preoperative therapy for LARC with objectives of achieving an optimal balance of safety, cost effectiveness and clinical outcome, and to support further investigation of this regimen in a phase II/III setting. METHODS: In this phase I study, three dose levels (6Gy×5F, 7Gy×5F, 8Gy×5F to gross tumour volume, while keeping the rest of irradiated volume at 5Gy×5) of SCRT followed by four cycles of mFOLFOX6 chemotherapy as neoadjuvant therapy will be tested by using the traditional 3+3 design. The pCR rate, R0 resection rate, sphincter preservation rate and treatment related toxicity will be assessed. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of Fujian Medical University Union Hospital (No. 2017YF020-02) and all participants provided written informed consent. Results from our study will be disseminated in international peer-reviewed journals. All study procedures were developed in order to assure data protection and confidentiality. TRIAL REGISTRATION NUMBER: NCT03466424; Pre-results.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Ensaios Clínicos Fase I como Assunto/métodos , Neoplasias Retais/radioterapia , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Fluoruracila/administração & dosagem , Humanos , Leucovorina/administração & dosagem , Terapia Neoadjuvante , Estudos Observacionais como Assunto/métodos , Compostos Organoplatínicos/administração & dosagem , Avaliação de Resultados da Assistência ao Paciente , Seleção de Pacientes , Cuidados Pré-Operatórios/métodos , Dosagem Radioterapêutica , Neoplasias Retais/tratamento farmacológico , Neoplasias Retais/cirurgia
11.
Eur J Cancer ; 104: 145-150, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30352382

RESUMO

Severe treatment-induced toxicities can have clinical consequences such as hospitalisation or treatment modifications, which in turn may deteriorate the prognosis of patients with cancer. Identification of determinants of treatment-induced toxicities is essential to develop strategies that promote therapy compliance and enhance the quality of life. Whereas toxicities are systematically recorded and graded per protocol in most clinical trials, observational studies often depend on retrospective data collection from medical records collected as standard care. Existing population-based or patient cohorts are a valuable source of information, even when relying on retrospective data collection, but comparisons across studies are hampered by a lack of a uniform definition for toxicity outcomes. We propose a new standardised approach to summarise toxicities in observational studies that rely on medical records for outcome assessment. We recommend the term 'toxicity-induced modification of treatment' (TIMT) to cover all toxicities that are responsible for changes in a planned treatment schedule. We define a TIMT as (i) a dose reduction, (ii) temporary interruption, (iii) discontinuation of therapy or (iv) an unanticipated switch to another regimen, as a result of treatment-induced toxicities and not because of progressive disease. This definition will provide clinically relevant information, especially when data on specific adverse events and Common Terminology Criteria for Adverse Events (CTCAE) grades are not uniformly available. Implementation of this definition empowers comparisons across studies, facilitates communication between clinicians and researchers and will allow new research questions in this active field of research.


Assuntos
Gerenciamento Clínico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Neoplasias/tratamento farmacológico , Estudos Observacionais como Assunto , Avaliação de Resultados em Cuidados de Saúde/métodos , Terminologia como Assunto , Assistência ao Convalescente , Antineoplásicos/administração & dosagem , Antineoplásicos/efeitos adversos , Composição Corporal , Substituição de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Humanos , Efeitos Adversos de Longa Duração , Dose Máxima Tolerável , Prontuários Médicos , Terapia Nutricional , Estudos Observacionais como Assunto/métodos , Estudos Observacionais como Assunto/normas , Avaliação de Resultados em Cuidados de Saúde/normas , Qualidade de Vida , Suspensão de Tratamento
12.
Rev Epidemiol Sante Publique ; 66(3): 217-225, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29685700

RESUMO

Randomized clinical trials are considered as the preferred design to assess the potential causal relationships between drugs or other medical interventions and intended effects. For this reason, randomized clinical trials are generally the basis of development programs in the life cycle of drugs and the cornerstone of evidence-based medicine. Instead, randomized clinical trials are not the design of choice for the detection and assessment of rare, delayed and/or unexpected effects related to drug safety. Moreover, the highly homogeneous populations resulting from restrictive eligibility criteria make randomized clinical trials inappropriate to describe comprehensively the safety profile of drugs. In that context, observational studies have a key added value when evaluating the benefit-risk balance of the drugs. However, observational studies are more prone to bias than randomized clinical trials and they have to be designed, conducted and reported judiciously. In this article, we discuss the strengths and limitations of randomized clinical trials and of observational studies, more particularly regarding their contribution to the knowledge of medicines' safety profile. In addition, we present general recommendations for the sensible use of observational data.


Assuntos
Avaliação Pré-Clínica de Medicamentos/métodos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Estudos Observacionais como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Medicina Baseada em Evidências , Humanos , Estudos Observacionais como Assunto/métodos , Estudos Observacionais como Assunto/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa , Medição de Risco
13.
Intern Med J ; 47(12): 1422-1432, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28892303

RESUMO

BACKGROUND/OBJECTIVES: The risk of renal cell carcinoma (RCC) in individuals who regularly drink coffee is controversial. Several antioxidant compounds in coffee have been proposed to reduce the risk of RCC, while the findings from several studies raise concerns regarding a potential increased risk of RCC with coffee consumption. AIM: This meta-analysis aims to evaluate the association between coffee consumption and RCC. METHODS: A literature search was performed using MEDLINE, EMBASE and Cochrane Database of Systematic Reviews from inception until December 2016. Studies that reported odd ratios or hazard ratios comparing the risk of RCC in individuals who consumed a significant amount of coffee (at least one cup of coffee per day) versus those who did not consume coffee were included. Pooled risk ratios (RR) and 95% confidence intervals (CI) were computed using a random-effect, generic inverse variance method. RESULTS: Twenty-two observational studies (16 case-control and 6 cohort studies) were included in our analysis to assess the association between RCC and coffee consumption. The pooled RR of RCC in individuals consuming coffee was 0.99 (95% CI, 0.89-1.11). Subgroup analyses stratified by gender showed pooled RRs of RCC of 1.15 (95% CI, 0.85-1.55) in females and 0.87 (95% CI, 0.72-1.04) in males. CONCLUSIONS: Our study demonstrates no significant association between coffee consumption and RCC. Thus, coffee consumption is likely not a risk factor for RCC. Whether coffee consumption has a potential role in reduced risk of RCC, particularly in men, requires further investigations.


Assuntos
Carcinoma de Células Renais/diagnóstico , Carcinoma de Células Renais/epidemiologia , Café , Neoplasias Renais/diagnóstico , Neoplasias Renais/epidemiologia , Carcinoma de Células Renais/induzido quimicamente , Estudos de Casos e Controles , Café/efeitos adversos , Estudos de Coortes , Feminino , Humanos , Neoplasias Renais/induzido quimicamente , Masculino , Estudos Observacionais como Assunto/métodos , Fatores de Risco
14.
J Psychosom Res ; 86: 20-7, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-27302542

RESUMO

OBJECTIVE: Melatonin plays a major role in maintaining circadian rhythm. Previous studies showed that its secretion pattern and levels could be disturbed in persons with dementia, psychiatric disorders, sleep disorders or with cancer. Also ageing is a factor that could alter melatonin levels, although previous research provides contradicting results. As melatonin supplementation is increasingly applied in older persons as sleep medication, it is important to know if melatonin levels decrease in healthy ageing and/or secretion patterns change. The objective of this study is to determine physiological levels and secretion patterns of melatonin in healthy older people. METHODS: We performed a systematic review and searched PubMed and Embase for studies published between January 1st 1980 and October 5th 2015 that measured melatonin in healthy persons aged ≥65years. RESULTS: Nineteen studies were retrieved. The number of participants ranged from 5 to 60 per study. Melatonin was mostly measured by radioimmunoassay (RIA) and the number of measurements per 24hours varied from 1 to 96. Sixteen studies showed a secretion pattern with a clear peak concentration, mostly at 0200h or 0300h. Maximum concentrations varied greatly from 11.2 to 91.3pgml(-1). Maximum melatonin level in studies with participants mean aged 65-70years was 49.3pgml(-1) and in studies with participants mean aged ≥75years 27.8pgml(-1), p-value <0.001. CONCLUSION: Total melatonin production in 24hours seems not to change in healthy ageing, but the maximal nocturnal peak concentration of melatonin might decline. It is important to take this into account when prescribing melatonin supplementation to older people.


Assuntos
Envelhecimento/sangue , Nível de Saúde , Melatonina/administração & dosagem , Melatonina/sangue , Idoso , Idoso de 80 Anos ou mais , Envelhecimento/psicologia , Ritmo Circadiano/efeitos dos fármacos , Ritmo Circadiano/fisiologia , Demência/sangue , Demência/tratamento farmacológico , Demência/psicologia , Suplementos Nutricionais , Feminino , Humanos , Masculino , Melatonina/fisiologia , Estudos Observacionais como Assunto/métodos , Sono/efeitos dos fármacos , Sono/fisiologia , Transtornos do Sono-Vigília/sangue , Transtornos do Sono-Vigília/tratamento farmacológico , Transtornos do Sono-Vigília/psicologia
15.
Int J Cardiol ; 178: 111-6, 2015 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-25464233

RESUMO

INTRODUCTION: Vitamin D (vit D) deficiency may be associated with an increased risk of statin-related symptomatic myalgia in statin-treated patients. The aim of this meta-analysis was to substantiate the role of serum vitamin D levels in statin-associated myalgia. METHODS: The search included PUBMED, Cochrane Library, Scopus, and EMBASE from January 1, 1987 to April 1, 2014 to identify studies that investigated the impact of vit D levels in statin-treated subjects with and without myalgia. Two independent reviewers extracted data on study characteristics, methods and outcomes. Quantitative data synthesis was performed using a fixed-effect model. RESULTS: The electronic search yielded 437 articles; of those 20 were scrutinized as full texts and 13 studies were considered unsuitable. The final analysis included 7 studies with 2420 statin-treated patients divided into subgroups of patients with (n=666 [27.5%]) or without (n=1754) myalgia. Plasma vit D concentrations in the symptomatic and asymptomatic subgroups were 28.4±13.80ng/mL and 34.86±11.63ng/mL, respectively. The combination of data from individual observational studies showed that vit D plasma concentrations were significantly lower in patients with statin-associated myalgia compared with patients not manifesting this side effect (weighted mean difference -9.41ng/mL; 95% confidence interval: -10.17 to -8.64; p<0.00001). CONCLUSIONS: This meta-analysis provides evidence that low vit D levels are associated with myalgia in patients on statin therapy. Randomized controlled trials are necessary to establish whether vitamin D supplementation reduces the risk for statin-associated myalgia.


Assuntos
Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Mialgia/sangue , Mialgia/induzido quimicamente , Vitamina D/sangue , Biomarcadores/sangue , Humanos , Mialgia/diagnóstico , Estudos Observacionais como Assunto/métodos
17.
Int J Cardiol ; 170(2 Suppl 1): S21-7, 2013 Dec 20.
Artigo em Inglês | MEDLINE | ID: mdl-24016540

RESUMO

In the past years, in vitro and animal studies have demonstrated several direct and indirect anti-arrhythmic effects of n-3 polyunsaturated fatty acids (n-3 PUFAs), at least in part mediated by anti-oxidant, anti-inflammatory and antifibrotic properties. Several epidemiological and clinical studies have been conducted to investigate the eventual benefits of fish oils in the prevention of cardiovascular diseases. The aim of this paper is to critically review current evidence on the anti-arrhythmic effects of n-3 PUFAs in the prevention of sudden cardiac death (SCD) and atrial fibrillation (AF). Published data are conflicting, but some benefits have been reported in the prevention of SCD after myocardial infarction and of AF, generally after long-course administration.


Assuntos
Antiarrítmicos/administração & dosagem , Arritmias Cardíacas/dietoterapia , Ácidos Graxos Ômega-3/administração & dosagem , Animais , Antiarrítmicos/metabolismo , Arritmias Cardíacas/metabolismo , Arritmias Cardíacas/prevenção & controle , Ácidos Graxos Ômega-3/metabolismo , Humanos , Estudos Observacionais como Assunto/métodos , Prevenção Secundária/métodos , Resultado do Tratamento
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