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- ItemAcesso aberto (Open Access)Agentes antiplaquetários para o tratamento da trombose venosa profunda : revisão sistemática Cochrane(Universidade Federal de São Paulo (UNIFESP), 2017-12-20) Flumignan, Carolina Dutra Queiroz [UNIFESP]; Silva, José Carlos Costa Baptista da [UNIFESP]; Amorim, Jorge Eduardo de [UNIFESP]; Nakano, Luis Carlos Uta [UNIFESP]; Jorge Eduardo de Amorim : http://lattes.cnpq.br/4643413023371496 ; Luis Carlos Uta Nakano : http://lattes.cnpq.br/7498955151131694 ; http://lattes.cnpq.br/7216436712130915; http://lattes.cnpq.br/4945693154870418; Universidade Federal de São Paulo (UNIFESP)Introdução: Os agentes antiplaquetários (AA) podem ser úteis para melhorar o tratamento da trombose venosa profunda (TVP) juntamente com a melhor prática médica (MPM), que inclui anticoagulação, meias de compressão elástica graduada e cuidados clínicos. Os AA poderiam minimizar complicações como síndrome pós-trombótica (SPT) e embolia pulmonar (EP) e diminuir a recorrência da doença, embora isso possa aumentar a chance de eventos hemorrágicos. Há também um potencial em alterar a morbidade e a mortalidade relacionadas à TVP, EP e SPT com o seu uso. No entanto, as evidências de maior qualidade disponíveis ainda são conflitantes. Objetivos: Avaliar os efeitos dos AA em adição à MPM atual, comparado com os efeitos da MPM (com ou sem placebo) para tratamento da TVP através de uma revisão sistemática Cochrane. Método: Foi realizada a busca de maneira sistemática, de acordo com o método Cochrane e com finalidade de se condensar todos os ensaios clínicos randomizados (ECR) que avaliaram o uso de algum tipo de AA como única diferença entre os grupos em adição à MPM para TVP, com ou sem uso de placebo. Resultados: Foram incluídos cinco estudos com 1.042 participantes e os resultados foram apresentados por 24 meses de acompanhamento. Das quatro comparações préespecificadas, apenas uma (AA com uso da MPM versus MPM mais placebo) para TVP em fase aguda não teve ECRs incluídos. Evidências de qualidade moderada sugerem que o uso de AA para o tratamento da TVP em fase crônica, após a interrupção do tratamento inicial padrão com anticoagulantes, reduz o risco de tromboembolismo venoso (TEV) recorrente de 3 a 24 meses de seguimento [risco relativo (RR) 0,52; intervalo de confiança (IC) 95% de 0,31 a 0,87; três estudos; 318 participantes; P = 0,01; I2 = 37%]. Não houve diferença significativa entre os grupos em relação à mortalidade até 3 meses de seguimento, com evidência de qualidade moderada (RR 0,33; IC 95% de 0,01 a 7,55; dois estudos; 66 participantes; P = 0,49; I2 não aplicável) nem em incidência de eventos adversos aos 18 meses de seguimento, com evidência de qualidade moderada (RR 7; IC 95% de 0,39 a 126,92; um estudo; 38 participantes; P = 0,19; I2 não aplicável). Evidências de baixa qualidade baseadas em apenas um ECR (224 participantes), que avaliou AA em TVP em fase crônica sem controle de placebo, sugerem uma redução no risco de TEV recorrente sem riscos adicionais, como sangramento maior, mortalidade e qualquer eventos adversos. Na TVP em fase aguda, encontrou-se um estudo que apresentou menor risco de síndrome pós-trombótica no uso do AA (RR 0,74; IC 95% de 0,61 a 0,91; P = 0,003; I2= 50%), com maior risco de eventos adversos (RR 2,88; IC 95% de 1,06 a 7,80; P = 0,04; I2= 0%), com evidências de qualidade muito baixa. Conclusões: Evidências de qualidade moderada favorecem o uso de AA para o tratamento da TVP em adição à MPM em fase crônica, e são baseadas no aparente equilíbrio entre os benefícios e os danos dessa intervenção.
- ItemAcesso aberto (Open Access)Angioplastia para trombose venosa profunda: revisão sistemática cochrane(Universidade Federal de São Paulo (UNIFESP), 2016-05-25) Flumignan, Ronald Luiz Gomes [UNIFESP]; Silva, Jose Carlos Costa Baptista da [UNIFESP]; http://lattes.cnpq.br/7216436712130915; http://lattes.cnpq.br/6751410694690699; Universidade Federal de São Paulo (UNIFESP)Objectives: To evaluate the effectiveness and safety of angioplasty (with or without stent) alone or more anticoagulation or more anticoagulation and thrombolysis in treating people with deep venous thrombosis, acute or chronic, through a Cochrane systematic review. Method: It was utilized the recommended Cochrane method. All randomized controlled trials that have examined angioplasty for deep venous thrombosis, along the lines of the objectives were considered. Searches were carried out in specialized register, the Cochrane Register of Studies and on the basis ?Literatura Latino Americana e do Caribe em Ciências da Saúde? e ?Indice Bibliográfico Español de Ciencias de la Salud?. References of the included studies were checked for other relevant studies. Experts, manufacturers and the authors of the included studies were contacted for any unpublished data. Participants who have received any form of mechanical thrombectomy were excluded. Two reviewers selected and extracted data from the studies independently. A third reviewer was consulted in case of disagreements. Results: Of the 12 pre-specified comparisons, only one [angioplasty (with or without stent) plus thrombolysis and best medical practice against best medical practice and thrombolysis] was identified for acute deep venous thrombosis. In both included studies (238 participants) thrombolysis was catheter-directed performed in the two groups: control and angioplasty. At 24 months, there was no difference in the incidence of venous thromboembolism and post-thrombotic syndrome. The most marked effects with angioplasty were seen in improving secondary patency (angioplasty group), which results in both periods early (12 months follow-up) and intermediate (24 months) showed significant differences. There were no cases of death or major bleeding and there was no difference in quality of life between the study arms (intermediate). The quality of the evidence, at 24 months of follow-up is moderate [lowered by indirectness (post-thrombotic syndrome) and imprecision (venous thromboembolism)]. Conclusions: This is the first systematic review of randomized controlled trials that with moderate-quality evidence suggests that angioplasty (with or without stent) offers potential advantages over standard treatment of deep venous thrombosis, through improved patency rate, without additional risk such as mortality, pulmonary embolism, major bleeding or recurrent DVT, even without significant improvement in quality of life and post-thrombotic syndrome in 24 months of follow-up.
- ItemSomente MetadadadosA Double-Blind Randomized Controlled Trial To Study the Efficacy of Topiramate in a Civilian Sample of PTSD(Wiley-Blackwell, 2011-01-01) Yeh, Mary S. L. [UNIFESP]; Mari, Jair Jesus [UNIFESP]; Pupo Costa, Mariana Caddrobi [UNIFESP]; Andreoli, Sergio Baxter [UNIFESP]; Bressan, Rodrigo Affonseca [UNIFESP]; Mello, Marcelo Feijo [UNIFESP]; Universidade Federal de São Paulo (UNIFESP); Univ LondonObjective: To evaluate the efficacy and tolerability of topiramate in patients with post-traumatic stress disorder (PTSD). Method: We conducted a 12-week double-blind, randomized, placebo-controlled study comparing topiramate to placebo. Men and women aged 18-62 years with diagnosis of PTSD according to DSM-IV were recruited from the outpatient clinic of the violence program of Federal University of São Paulo Hospital (Prove-UNIFESP), São Paulo City, between April 2006 and December 2009. Subjects were assessed for the Clinician-Administered Posttraumatic Stress Scale (CAPS), Clinical Global Impression, and Beck Depression Inventory (BDI). After 1-week period of washout, 35 patients were randomized to either group. the primary outcome measure was the CAPS total score changes from baseline to the endpoint. Results: 82.35% of patients in the topiramate group exhibited improvements in PTSD symptoms. the efficacy analysis demonstrated that patients in the topiramate group exhibited significant improvements in reexperiencing symptoms: flashbacks, intrusive memories, and nightmares of the trauma (CAPS-B; P = 0.04) and in avoidance/numbing symptoms associated with the trauma, social isolation, and emotional numbing (CAPS-C; P = 0.0001). Furthermore, the experimental group demonstrated a significant difference in decrease in CAPS total score (topiramate -57.78; placebo -32.41; P = 0.0076). Mean topiramate dose was 102.94 mg/d. Topiramate was generally well tolerated. Conclusion: Topiramate was effective in improving reexperiencing and avoidance/numbing symptom clusters in patients with PTSD. This study supports the use of anti-convulsants for the improvement of symptoms of PTSD.
- ItemAcesso aberto (Open Access)Efetividade da intervenção educativa para redução da ansiedade e do estresse de pacientes que aguardam o cateterismo cardíaco: ensaio clínico randomizado(Universidade Federal de São Paulo (UNIFESP), 2018-05-24) Murakami, Luisa [UNIFESP]; Lopes, Juliana de Lima [UNIFESP]; http://lattes.cnpq.br/1478157388713375; http://lattes.cnpq.br/7400685742669859; São Paulo; Universidade Federal de São Paulo (UNIFESP)Objectives: To assess the effectiveness of an educational intervention, guided by informative booklet, on the anxiety and stress levels of patients awaiting cardiac catheterization (CATE) and assess the relationship of sociodemographic and clinical variables with anxiety and stress. Method: This randomized, controlled and blind clinical trial was conducted in a cardiac hospital located in São Paulo, Brazil. The patients waiting for a CATE were allocated for the intervention (IG) or control group (CG) in a parallel and random manner. The IG received specific written information regarding CATE provided in a previously validated booklet, while the CG received only routine information regularly provided in the unit. Anxiety and stress were assessed, before and after the interventions, using the StateTrait Anxiety Inventory and Perceived Stress Scale, respectively, and by checking physiological effects on vital parameters. The independent variables assessed were: age, sex, race, marital status, education, cardiovascular risk factors, use of βblockers, vasodilator and angiotensin converting enzyme inhibitors, prior medical diagnosis and/or depression symptoms, prior hospitalizations and/or prior experience with percutaneous interventions, and place of hospitalization. ANOVA was used to assess altered levels of anxiety and stress in relation to time and groups. Fisher’s exact test and Student’s t test or the MannWhitney test was used to verify association of independent variables with anxiety and stress. Level of significance was established at 5% and test power was 0.90. The project was approved by the Institutional Review Board and registered in the Clinical Trials Registry. Results: A total of 128 individuals were eligible, however, the sample was composed of 122 participants, 61 of whom were assigned to the CG (59.4±8.27 years old; 82% were male) and 61 to the IG (61.9±9.67 years old; 72% were male). The groups were homogeneous, with the exception of race (CG: 62% x IG: 80% of Caucasians; p=0.044. More than half of the participants in both groups presented hypertension, sedentariness, dyslipidemia, and a prior family history of cardiovascular diseases. Most participants presented a low or moderate level of anxiety and a low level of stress in the first assessment. Levels of anxiety and stress did not change from the first to second point in time (anxiety, p=0.225 and stress, p=0.696), in terms of interaction (anxiety, p=0.183 and stress, p=0.444), or in terms of groups (anxiety, p=0.341 and stress, p=0.624). Anxiety presented a significantly relationship with the youngest participants (p=0.033), who reported stress (p=0.046) and former smoking (p=0.013). Stress was related with being a smoker (p=0.001) and being younger (p=0.019). Conclusion: This study’s hypothesis that an educational intervention provided through an informative booklet would decrease anxiety and stress among patients awaiting CATE was not confirmed. Anxiety was related to age, stress and smoking, while stress was related to smoking and age.
- ItemAcesso aberto (Open Access)Intervenção precoce ou tardia para pacientes recentemente sintomáticos com estenose de carótida: revisão sistemática Cochrane(Universidade Federal de São Paulo (UNIFESP), 2016-12-31) Vasconcelos, Vladimir Tonello de [UNIFESP]; Silva, José Carlos Costa Baptista da [UNIFESP]; http://lattes.cnpq.br/7216436712130915; http://lattes.cnpq.br/7031191726790609; Universidade Federal de São Paulo (UNIFESP)Objectives: To assess the risks and benefits of performing very early cerebral revascularization (within two days) compared with delayed treatment (after two days) for people with recently symptomatic carotid artery stenosis. Methods: We searched the Cochrane Stroke Group Trials Register in January 2016, the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2016, Issue 1), MEDLINE (1948 to 26 January 2016), EMBASE (1974 to 26 January 2016), LILACS (1982 to 26 January 2016), and trial registers (from inception to 26 January 2016). We contacted colleagues and pharmaceutical companies to identify further studies and unpublished trials. All completed, truly randomized trials (RCT) that compared very early cerebral revascularization (within two days) with delayed treatment (after two days) for people with recently symptomatic carotid artery stenosis. We independently selected trials for inclusion according to the above criteria, assessed risk of bias for each trial, and performed data extraction. We utilized an intention-to-treat analysis strategy. Results: We identified one single RCT that involved 40 participants, and addressed the timing of surgery for people with recently symptomatic carotid artery stenosis. It compared very early surgery with surgery performed after 14 days of the last symptomatic event. The overall quality of the evidence was very low, due to the small number of participants from only one trial, and missing outcome data. We found no statistically significant difference between the effects of very early or delayed surgery in reducing the combined risk of stroke and death within 30 days of surgery (risk ratio (RR) 3.32; confidence interval (CI) 0.38 to 29.23; very low-quality evidence), or the combined risk of perioperative death and stroke (RR 0.47; CI 0.14 to 1.58; very lowquality evidence). To date, no results are available to confirm the optimal timing for surgery. Conclusions: There is currently no high-quality evidence available to support either very early or delayed cerebral revascularization after a recent ischemic stroke. Hence, further randomized trials to identify which patients should undergo very urgent revascularization are needed. Future studies should stratify participants by age group, sex, grade of ischemia, and degree of stenosis.
- ItemAcesso aberto (Open Access)Validade da produção científica de acesso aberto indexada na base de dados Lilacs em odontologia(Universidade Federal de São Paulo (UNIFESP), 2010) Ferreira, Christiane Alves [UNIFESP]; Saconato, Humberto [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)Objetivos: Realizar uma análise metodológica da área de odontologia quanto ao risco de viés de ensaios controlados randomizados (ECR) de acesso aberto, disponibilizados na base de dados Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde), avaliar a potencial contribuição da Lilacs como fonte de estudos primários para revisões sistemáticas da literatura e avaliar possível associação entre a base Qualis, tipo de estudo e risco de viés. Material e Métodos: Foram selecionados 40 periódicos de acesso aberto da base Lilacs. Uma busca manual página a página foi conduzida para identificar os artigos publicados, de acordo com o tipo de estudo, durante um período de seis anos. A classificação dos estudos foi realizada por revisores independentes com a confiabilidade avaliada por estatística Kappa. Os ECR identificados foram separados para a avaliação do risco de viés. Foram coletados dados sobre: geração da seqüência de alocação, sigilo da alocação, cegamento, dados de desfechos incompletos, número de dimensões de baixo risco de viés, país e Qualis. As associações foram avaliadas pelos testes de Kruskal-Wallis, Mann Withney e Kendal tau, correlação de Sperman e análise de regressão. Resultados: A pesquisa manual recuperou 4879 artigos com predominância de estudos com baixo nível de evidência (92%). Estudos com alto nível de evidência para avaliação de intervenções representavam apenas 1,94% dos artigos indexados. Estudos epidemiológicos como Caso-Controle e Coorte eram apenas 1,41%. O Brasil representou 72% do total de publicações, entretanto, 64,42% dos estudos utilizaram projetos de pesquisa com baixo nível de evidência. Dos 78 estudos classificados, somente 10 eram verdadeiros ECR e, destes, somente um único estudo era de baixo risco de viés. O item mais frequentemente nos ECR avaliados foi cegamento. A base Qualis não estava associada à hierarquia de evidência e nem às dimensões de risco de viés. Conclusão: O conjunto de estudos em odontologia indexados na base Lilacs se constitui em um corpo de evidência muito limitado para fornecer estudos primários elegíveis com alto nível de evidência para autores de revisões sistemáticas, para clínicos e gestores sobre intervenções, prognóstico ou etiologia em odontologia.