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1.
Rev Assoc Med Bras (1992) ; 65(7): 982-987, 2019 Aug 05.
Artigo em Inglês | MEDLINE | ID: mdl-31389509

RESUMO

OBJECTIVE: A clinical, placebo-controlled, randomized, double-blind trial with two parallel groups. OBJECTIVE: to evaluate the efficacy of ropivacaine injection in each belly of the anterior and middle scalene muscles, guided by ultrasonography, in the treatment of Nonspecific Thoracic Outlet Syndrome (TOS) compared to cutaneous pressure. METHODS: 38 patients, 19 in the control group (skin pressure in each belly of the anterior and middle scalene muscles) and 19 in the intervention group (ropivacaine). Subjects with a diagnosis of Nonspecific Thoracic Outlet Syndrome, pain in upper limbs and/or neck, with no radiculopathy or neurological involvement of the limb affected due to compressive or encephalic root causes were included. The primary endpoint was functionality, evaluated by the Disabilities of the Arm, Shoulder, and Hand - DASH scale validated for use in Brasil. The time of the evaluations were T0 = before the intervention; T1 = immediately after; T2 = 1 week; T3 = 4 weeks; T4 = 12 weeks; for T1, the DASH scale was not applied. RESULTS: Concerning the DASH scale, it is possible to affirm with statistical significance (p> 0.05) that the intervention group presented an improvement of functionality at four weeks, which was maintained by the 12th week. CONCLUSION: In practical terms, we concluded that a 0.375% injection of ropivacaine at doses of 2.5 ml in each belly of the anterior and middle scalene muscles, guided by ultrasonography, in the treatment of Nonspecific Thoracic Outlet Syndrome helps to improve function.


Assuntos
Anestésicos Locais/administração & dosagem , Injeções Intramusculares/métodos , Músculos do Pescoço/efeitos dos fármacos , Ropivacaina/administração & dosagem , Síndrome do Desfiladeiro Torácico/tratamento farmacológico , Ultrassonografia de Intervenção/métodos , Método Duplo-Cego , Feminino , Humanos , Masculino , Fatores de Tempo , Resultado do Tratamento
2.
Rev. Assoc. Med. Bras. (1992) ; 65(7): 982-987, July 2019. tab, graf
Artigo em Inglês | LILACS-Express | ID: biblio-1013009

RESUMO

SUMMARY A clinical, placebo-controlled, randomized, double-blind trial with two parallel groups. OBJECTIVE to evaluate the efficacy of ropivacaine injection in each belly of the anterior and middle scalene muscles, guided by ultrasonography, in the treatment of Nonspecific Thoracic Outlet Syndrome (TOS) compared to cutaneous pressure. METHODS 38 patients, 19 in the control group (skin pressure in each belly of the anterior and middle scalene muscles) and 19 in the intervention group (ropivacaine). Subjects with a diagnosis of Nonspecific Thoracic Outlet Syndrome, pain in upper limbs and/or neck, with no radiculopathy or neurological involvement of the limb affected due to compressive or encephalic root causes were included. The primary endpoint was functionality, evaluated by the Disabilities of the Arm, Shoulder, and Hand - DASH scale validated for use in Brasil. The time of the evaluations were T0 = before the intervention; T1 = immediately after; T2 = 1 week; T3 = 4 weeks; T4 = 12 weeks; for T1, the DASH scale was not applied. RESULTS Concerning the DASH scale, it is possible to affirm with statistical significance (p> 0.05) that the intervention group presented an improvement of functionality at four weeks, which was maintained by the 12th week. CONCLUSION In practical terms, we concluded that a 0.375% injection of ropivacaine at doses of 2.5 ml in each belly of the anterior and middle scalene muscles, guided by ultrasonography, in the treatment of Nonspecific Thoracic Outlet Syndrome helps to improve function.


RESUMO Ensaio clínico, controlado por placebo, aleatorizado, duplo-cego, com dois braços paralelos. OBJETIVO Avaliar a eficácia da injeção de ropivacaína em cada ventre dos músculos escalenos anterior e médio, guiada por ultrassonografia, no tratamento da Síndrome do Desfiladeiro Torácico Neurogênico inespecífico comparado com o toque cutâneo. MÉTODOS Trinta e oito pacientes, sendo 19 no grupo controle (toque cutâneo em cada ventre dos músculos escalenos anterior e médio) e 19 no grupo intervenção (ropivacaína). Foram incluídos sujeitos com diagnóstico de Síndrome do Desfiladeiro Torácico Neurogênico inespecífico com dor em membros superiores e/ou cervicalgia sem radiculopatia ou comprometimento neurológico do membro em questão por causas radiculares compressivas ou encefálicas. O desfecho primário foi a funcionalidade avaliada pela escala Disabilitie of the Arm, Shoulder and Hand - Dash, validada no Brasil. O tempo das avaliações foram T0 = antes da intervenção; T1 = imediatamente após, T2 = 1 semana, T3 = 4 semanas e T4 = 12 semanas, sendo que para o T1 não foi aplicado o Dash. RESULTADOS Com relação ao Dash, de forma estatisticamente significante (p>0,05), é possível afirmar que o grupo intervenção apresentou melhora da funcionalidade a partir de quatro semanas, e essa melhora se manteve até a 12a semana. CONCLUSÃO Em termos práticos, conclui-se que a injeção de ropivacaína 0,375% nas doses de 2,5 ml em cada ventre dos músculos escalenos anterior e médio, guiada por ultrassonografia, no tratamento da Síndrome do Desfiladeiro Torácico Neurogênico inespecífico auxilia na melhora da função.

3.
Rev Assoc Med Bras (1992) ; 60(3): 222-30, 2014 May-Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25004267

RESUMO

OBJECTIVE: To estimate the number of hospitalizations attributable to diabetes mellitus (DM) and its complications within the public healthcare system in Brazil (SUS) and the mean cost paid per hospitalization. METHODS: The official database from the Hospital Information System of the Unified Health System (SIH/SUS) was consulted from 2008 to 2010. The proportion of hospitalizations attributable to DM was estimated using attributable risk methodology. The mean cost per hospitalization corresponds to direct medical costs in nursing and intensive care, from the perspective of the SUS. RESULTS: The proportion of hospitalizations attributable to DM accounted for 8.1% to 12.2% of total admissions in the period, varying according to use of maximum (self-reported with correction factor) or minimal (self-reported) DM prevalence. The hospitalization rate was 47 to 70.8 per 10.000 inhabitants per year. The mean cost per hospitalization varied from 1.302 Brazilian Reais (BRL) to 1,315 BRL. Assuming the maximum prevalence, hospitalizations were distributed as 10.3% as DM itself, 36.6% as chronic DM-associated complications and 53.1% as general medical conditions. Advancing age was accompanied by an increase in hospitalization rates and corresponding costs, and more pronounced in male patients. CONCLUSION: The results express the importance of DM in terms of the use of health care resources and demonstrate that studies of hospitalizations with DM as a primary diagnosis are not sufficient to assess the magnitude of the impact of this disease.


Assuntos
Assistência à Saúde/economia , Complicações do Diabetes/epidemiologia , Hospitalização/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Brasil/epidemiologia , Criança , Pré-Escolar , Custos e Análise de Custo , Bases de Dados Factuais , Complicações do Diabetes/economia , Diabetes Mellitus/economia , Diabetes Mellitus/epidemiologia , Feminino , Hospitalização/economia , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Prevalência , Adulto Jovem
5.
Rev. Assoc. Med. Bras. (1992) ; 60(3): 222-230, May-Jun/2014. tab
Artigo em Inglês | LILACS | ID: lil-713060

RESUMO

Objective: to estimate the number of hospitalizations attributable to diabetes mellitus (DM) and its complications within the public healthcare system in Brazil (SUS) and the mean cost paid per hospitalization. Methods: the official database from the Hospital Information System of the Unified Health System (SIH/SUS) was consulted from 2008 to 2010. The proportion of hospitalizations attributable to DM was estimated using attributable risk methodology. The mean cost per hospitalization corresponds to direct medical costs in nursing and intensive care, from the perspective of the SUS. Results: the proportion of hospitalizations attributable to DM accounted for 8.1% to 12.2% of total admissions in the period, varying according to use of maximum (self-reported with correction factor) or minimal (self-reported) DM prevalence. The hospitalization rate was 47 to 70.8 per 10.000 inhabitants per year. The mean cost per hospitalization varied from 1.302 Brazilian Reais (BRL) to 1,315 BRL. Assuming the maximum prevalence, hospitalizations were distributed as 10.3% as DM itself, 36.6% as chronic DM-associated complications and 53.1% as general medical conditions. Advancing age was accompanied by an increase in hospitalization rates and corresponding costs, and more pronounced in male patients. Conclusion: the results express the importance of DM in terms of the use of health care resources and demonstrate that studies of hospitalizations with DM as a primary diagnosis are not sufficient to assess the magnitude of the impact of this disease. .


Objetivo: estimar o número de hospitalizações atribuíveis ao diabete melito (DM) e suas complicações no Sistema Único de Saúde (SUS) brasileiro e avaliar o valor médio pago por hospitalização. Métodos: foram consultados bancos de dados do Sistema de Informações Hospitalares do Sistema Único de Saúde (SIH/SUS), no período de 2008 a 2010. As proporções de hospitalizações atribuíveis ao DM foram estimadas por meio da metodologia do risco atribuível. O custo médio por hospitalização correspondeu aos custos diretos médicos em enfermaria e tratamento intensivo, sob a perspectiva do SUS. Resultados: hospitalizações atribuíveis ao DM corresponderam a 8,1 a 12,2% do total de internações no período, variando de acordo com a utilização de prevalência máxima (autorreferida com fator de correção) ou mínima (autorreferida) para DM. A taxa de hospitalização foi de 47 a 70,8 por 10 mil habitantes por ano. O custo médio por hospitalização variou de R$ 1.302 a R$ 1.315. Assumindo-se a prevalência máxima, as hospitalizações se (*) Fractions attributable to chronic complications and general medical conditions calculated based on the self-reported prevalence from the VIGITEL survey (**) Fractions attributable to chronic complications and general medical conditions calculated based on the self-reported data expended to include the undiagnosed distribuíram em 10,3% como DM propriamente dito, 36,6% associadas às complicações crônicas do DM e 53,1% atribuídas a condições médicas gerais. O avanço da idade foi acompanhado pelo aumento nas taxas de hospitalizações e nos custos médios correspondentes, sendo mais acentuado nos pacientes do gênero ...


Assuntos
Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Assistência à Saúde/economia , Complicações do Diabetes/epidemiologia , Hospitalização/estatística & dados numéricos , Brasil/epidemiologia , Custos e Análise de Custo , Bases de Dados Factuais , Complicações do Diabetes/economia , Diabetes Mellitus/economia , Diabetes Mellitus/epidemiologia , Hospitalização/economia , Prevalência
7.
Acta fisiátrica ; 20(2)jun. 2013.
Artigo em Português | LILACS-Express | ID: lil-704982

RESUMO

Iniciamos a elaboração desta diretriz com a capacitação dos autores por meio da metodologia empregada pelo Oxford Centre for Evidence Based Medicine, para elaboração de diretrizes clínicas pelo Programa Diretrizes da Associação Médica Brasileira (AMB). Foram revisados artigos nas bases de dados do MedLine (PubMed) e outras fontes de pesquisa, sem limite de tempo. A estratégia de busca utilizada baseou-se em perguntas estruturadas na forma P.I.C.O. (das iniciais "Paciente", "Intervenção", "Controle", "Outcome").


We began the preparation of this guideline with the training of the authors using the methodology employed by the Oxford Centre for Evidence-Based Medicine, for the development of clinical guidelines for the Programa Diretrizes da Associação Médica Brasileira-AMB (Brazilian Medical Association?s Guideline Program-BMA). Articles were reviewed from the MEDLINE (PubMed) database and other research sources, on an open-ended basis. The search strategy used was based on structured questions in the P.I.C.O. form (from the initials of ?Patient?, ?Intervention?, ?Control?, and ?Outcome?).

8.
Rev Assoc Med Bras (1992) ; 58(3): 294-301, 2012 May-Jun.
Artigo em Inglês, Português | MEDLINE | ID: mdl-22735220

RESUMO

OBJECTIVES: To compare costs and clinical benefits of three additional therapies to metformin (MF) for patients with diabetes mellitus type 2 (DM2). METHODS: A discrete event simulation model was built to estimate the cost-utility ratio (cost per quality-adjusted life years [QALY]) of saxagliptine as an additional therapy to MF when compared to rosiglitazone or pioglitazone. A budget impact model (BIM) was built to simulate the economic impact of saxagliptine use in the context of the Brazilian private health system. RESULTS: The acquiring medication costs for the hypothetical patient group analyzed in a time frame of three years, were R$ 10,850,185, R$ 14,836,265 and R$ 14,679,099 for saxagliptine, pioglitazone and rosiglitazone, respectively. Saxagliptine showed lower costs and greater effectiveness in both comparisons, with projected savings for the first three years of R$ 3,874 and R$ 3,996, respectively. The BIM estimated cumulative savings of R$ 417,958 with the repayment of saxagliptine in three years from the perspective of a health plan with 1,000,000 covered individuals. CONCLUSION: From the perspective of private paying source, the projection is that adding saxagliptine with MF save costs when compared with the addition of rosiglitazone or pioglitazone in patients with DM2 that have not reached the HbA1c goal with metformin monotherapy. The BIM of including saxagliptine in the reimbursement lists of health plans indicated significant savings on the three-year horizon.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Adamantano/administração & dosagem , Adamantano/análogos & derivados , Adamantano/economia , Análise Custo-Benefício , Diabetes Mellitus Tipo 2/economia , Dipeptídeos/administração & dosagem , Dipeptídeos/economia , Quimioterapia Combinada/economia , Feminino , Humanos , Hipoglicemiantes/economia , Masculino , Metformina/administração & dosagem , Metformina/economia , Pessoa de Meia-Idade , Pioglitazona , Setor Privado , Rosiglitazona , Tiazolidinedionas/administração & dosagem , Tiazolidinedionas/economia
9.
Rev. Assoc. Med. Bras. (1992) ; 58(3): 294-301, May-June 2012. tab
Artigo em Português | LILACS | ID: lil-639552

RESUMO

OBJETIVOS: Comparar custos e benefícios clínicos de três terapias adicionais à metformina (MF) para pacientes com diabetes mellitus tipo 2 (DMT2). MÉTODOS: Um modelo de simulação de eventos discretos foi construído para estimar a relação custo-utilidade (custo por QALY) da saxagliptina como uma terapia adicional à MF comparada à rosiglitazona ou pioglitazona. Um modelo de impacto orçamentário (BIM - Budget Impact Model) foi construído para simular o impacto econômico da adoção de saxagliptina no contexto do Sistema Suplementar de Saúde brasileiro. RESULTADOS: O custo de aquisição da medicação para o grupo de pacientes hipotéticos analisados, para o horizonte temporal de três anos, foi de R$ 10.850.185,00, R$ 14.836.265,00 e R$ 14.679.099,00 para saxagliptina, pioglitazona e rosiglitazona, respectivamente. Saxagliptina exibiu menores custos e maior efetividade em ambas as comparações, com economias projetadas para os três primeiros anos de -R$ 3.874,00 e -R$ 3.996,00, respectivamente. O BIM estimou uma economia cumulativa de R$ 417.958,00 com o reembolso da saxagliptina em três anos a partir da perspectiva de uma operadora de plano de saúde com 1 milhão de vidas cobertas. CONCLUSÃO: Da perspectiva da fonte pagadora privada, a projeção é de que o acréscimo de saxagliptina à MF poupe custos quando comparado ao acréscimo de rosiglitazona ou pioglitazona em pacientes com DMT2 que não atingiram a meta de hemoglobina glicada (HbA1c) com metformina em monoterapia. O BIM, para a inclusão de saxagliptina nas listas de reembolso das operadoras de planos de saúde, indicou uma economia significativa para o horizonte de 3 anos.


OBJECTIVES: To compare costs and clinical benefits of three additional therapies to metformin (MF) for patients with diabetes mellitus type 2 (DM2). METHODS: A discrete event simulation model was built to estimate the cost-utility ratio (cost per quality-adjusted life years [QALY]) of saxagliptine as an additional therapy to MF when compared to rosiglitazone or pioglitazone. A budget impact model (BIM) was built to simulate the economic impact of saxagliptine use in the context of the Brazilian private health system. RESULTS: The acquiring medication costs for the hypothetical patient group analyzed in a time frame of three years, were R$ 10,850,185, R$ 14,836,265 and R$ 14,679,099 for saxagliptine, pioglitazone and rosiglitazone, respectively. Saxagliptine showed lower costs and greater effectiveness in both comparisons, with projected savings for the first three years of R$ 3,874 and R$ 3,996, respectively. The BIM estimated cumulative savings of R$ 417,958 with the repayment of saxagliptine in three years from the perspective of a health plan with 1,000,000 covered individuals. CONCLUSION: From the perspective of private paying source, the projection is that adding saxagliptine with MF save costs when compared with the addition of rosiglitazone or pioglitazone in patients with DM2 that have not reached the HbA1c goal with metformin monotherapy. The BIM of including saxagliptine in the reimbursement lists of health plans indicated significant savings on the three-year horizon.


Assuntos
Feminino , Humanos , Masculino , Pessoa de Meia-Idade , /tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Adamantano/administração & dosagem , Adamantano/análogos & derivados , Adamantano/economia , Análise Custo-Benefício , /economia , Dipeptídeos/administração & dosagem , Dipeptídeos/economia , Quimioterapia Combinada/economia , Hipoglicemiantes/economia , Metformina/administração & dosagem , Metformina/economia , Setor Privado , Tiazolidinedionas/administração & dosagem , Tiazolidinedionas/economia
10.
Pacing Clin Electrophysiol ; 32 Suppl 1: S247-51, 2009 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19250106

RESUMO

BACKGROUND: The incidence of venous lesions following transvenous cardiac device implantation is high. Previous implantation of temporary leads ipsilateral to the permanent devices, and a depressed left ventricular ejection fraction have been associated with an increased risk of venous lesions, though the effects of preventive strategies remain controversial. This randomized trial examined the effects of warfarin in the prevention of these complications in high-risk patients. METHOD: Between February 2004 and September 2007, we studied 101 adults who underwent a first cardiac device implantation, and who had a left ventricular ejection fraction < or =0.40, or a temporary pacing system ipsilateral to the permanent implant, or both. After device implantation, the patients were randomly assigned to warfarin to a target international normalized ratio of 2.0-3.5, or to placebo. Clinical and laboratory evaluations were performed regularly up to 6 months postimplant. Venous lesions were detected at 6 months by digital subtraction venography. RESULTS: Venous obstructions of various degrees were observed in 46 of the 92 patients (50.0%) who underwent venography. The frequency of venous obstructions was 60.4% in the placebo, versus 38.6% in the warfarin group (P = 0.018), corresponding to an absolute risk reduction of 22% (relative risk = 0.63; 95% confidence interval = 0.013-0.42). CONCLUSIONS: Warfarin prophylaxis lowered the frequency of venous lesions after transvenous devices implantation in high-risk patients.


Assuntos
Anticoagulantes/uso terapêutico , Eletrodos/efeitos adversos , Trombose Venosa/prevenção & controle , Varfarina/uso terapêutico , Estimulação Cardíaca Artificial/efeitos adversos , Comorbidade , Desfibriladores Implantáveis/efeitos adversos , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Marca-Passo Artificial/efeitos adversos , Flebografia , Fatores de Risco , Resultado do Tratamento , Trombose Venosa/epidemiologia , Trombose Venosa/etiologia , Varfarina/administração & dosagem
11.
Coron Artery Dis ; 20(2): 100-5, 2009 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19293667

RESUMO

OBJECTIVE: To delineate the effects of extracorporeal bypass on biomarkers of hemostasis, fibrinolysis, and inflammation and clinical sequelae. METHODS: Patients were assigned prospectively and randomly to either on-pump (n=41) or off-pump (n=51) coronary bypass surgery. The concentrations of C-reactive protein, fibrinogen, D-dimer, and plasminogen activator inhibitor type-1 in blood were quantified before and after (1 and 24 h) surgery. Similar surgical and anesthetic procedures were used for both groups. Clinical events were assessed during initial hospitalization and at the end of 1 year. RESULTS: The concentrations of plasminogen activator inhibitor type-1 and D-dimer were greater compared with preoperative values 1 and 24 h after surgery in both groups, but their concentrations increased to a greater extent 24 h after surgery in the on-pump group (P<0.01). The concentration of C-reactive protein did not change appreciably immediately after surgery in either group but increased in a parallel manner 24 h after either on-pump or off-pump surgery (P<0.01). Bypass surgery in the on-pump group was associated with greater blood loss during surgery and more bleeding after surgery (P< or =0.01). The incidence of all other complications was similar in the two groups. CONCLUSION: On-pump surgery was associated with biochemical evidence of a prothrombotic state early after surgery but no greater incidence of thrombotic events was observed. The prothrombotic state might be a consequence of extracorporeal bypass, compensation in response to more bleeding, or both in patients undergoing on-pump surgery.


Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Ponte Cardiopulmonar/efeitos adversos , Ponte de Artéria Coronária sem Circulação Extracorpórea/efeitos adversos , Ponte de Artéria Coronária/efeitos adversos , Doença da Artéria Coronariana/cirurgia , Hemostasia , Hemorragia Pós-Operatória/prevenção & controle , Trombose/sangue , Idoso , Biomarcadores/sangue , Proteína C-Reativa/metabolismo , Doença da Artéria Coronariana/sangue , Feminino , Produtos de Degradação da Fibrina e do Fibrinogênio/metabolismo , Fibrinogênio/metabolismo , Fibrinólise , Humanos , Mediadores da Inflamação/sangue , Masculino , Pessoa de Meia-Idade , Inibidor 1 de Ativador de Plasminogênio/sangue , Hemorragia Pós-Operatória/sangue , Hemorragia Pós-Operatória/etiologia , Estudos Prospectivos , Trombose/etiologia , Fatores de Tempo , Resultado do Tratamento
13.
Rev. bras. cir. cardiovasc ; 23(4): 542-549, out.-dez. 2008. ilus, tab, graf
Artigo em Inglês, Português | LILACS | ID: lil-506039

RESUMO

OBJETIVOS: Avaliar a utilidade da varfarina na prevenção dessas complicações nos pacientes de alto risco. MÉTODOS: Estudo clínico prospectivo, randomizado, cego, em pacientes submetidos ao primeiro implante transvenoso de DCEI, com FEVE<0,40 e/ou MPT ipsilateral ao implante definitivo. Após o procedimento, os pacientes foram randomizados para o uso diário de placebo ou varfarina. Avaliações clínicas e laboratoriais foram realizadas periodicamente. A pesquisa de obstruções venosas foi feita pela venografia por subtração digital, seis meses após o implante. De fevereiro de 2004 a novembro de 2006, foram selecionados 101 pacientes, havendo homogeneidade das características clínicas e operatórias de ambos os grupos (P=NS). RESULTADOS: No grupo Varfarina, 31,4 por cento dos pacientes apresentaram obstruções venosas em comparação a 57,1 por cento do grupo Placebo (RR= 0,57; IC 95 por cento= 0,33 a 0,98; P= 0,015). No grupo Varfarina, 72 por cento dos exames de INR realizados encontraram-se em nível terapêutico. Houve um caso de sangramento gastrintestinal, que justificou a interrupção do uso da varfarina e mudança para o grupo Placebo. CONCLUSÃO: Os resultados preliminares mostraram que o uso profilático da anticoagulação mostrou-se seguro e reduziu significativamente a incidência de obstruções venosas pós-implante de DCEI nos pacientes de alto risco.


OBJECTIVES: To evaluate the efficacy of prophylactic use of warfarin in patients with high risk of lead-associated thrombosis. METHODS: Clinical, prospective, randomized and blinded study, in patients submitted to first transvenous leads implantation with LVEF <0.40 and/or previous ipsilateral temporary pacing. After device implantation, patients were randomly assigned to placebo or warfarin. Periodical clinical and laboratorial evaluations were performed to anticoagulant management. After a six-month period, every patient was submitted to a digital subtraction venography. From February 2004 to November 2006, 101 patients underwent randomization. Baseline characteristics were similar in both groups (P=NS). RESULTS: Venographic analysis showed 31.4 percent of venous obstructions in patients assigned to warfarin as compared with 57.1 percent in patients assigned to placebo (RR= 0.57 [95 percent CI, 0.33 to 0.98]; P=0.015). In the warfarin group, 72 percent of the PT/INR tests were in therapeutic INR range. Only one patient required warfarin discontinuation and cross-over to placebo group due to gastrointestinal bleeding. CONCLUSIONS: These preliminary results showed that the anticoagulation therapy has been safe and reduced the frequency of venous thrombosis after transvenous cardiac devices implantation in high risk patients.


Assuntos
Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Anticoagulantes/farmacologia , Marca-Passo Artificial , Complicações Pós-Operatórias/prevenção & controle , Trombose Venosa/prevenção & controle , Varfarina/farmacologia , Administração Oral , Estimulação Cardíaca Artificial , Métodos Epidemiológicos , Coeficiente Internacional Normatizado , Complicações Pós-Operatórias/sangue , Medição de Risco , Trombose Venosa/sangue
14.
Rev Bras Cir Cardiovasc ; 23(4): 542-9, 2008 Oct-Dec.
Artigo em Inglês, Português | MEDLINE | ID: mdl-19229428

RESUMO

OBJECTIVES: To evaluate the efficacy of prophylactic use of warfarin in patients with high risk of lead-associated thrombosis. METHODS: Clinical, prospective, randomized and blinded study, in patients submitted to first transvenous leads implantation with LVEF <0.40 and/or previous ipsilateral temporary pacing. After device implantation, patients were randomly assigned to placebo or warfarin. Periodical clinical and laboratorial evaluations were performed to anticoagulant management. After a six-month period, every patient was submitted to a digital subtraction venography. From February 2004 to November 2006, 101 patients underwent randomization. Baseline characteristics were similar in both groups (P=NS). RESULTS: Venographic analysis showed 31.4% of venous obstructions in patients assigned to warfarin as compared with 57.1% in patients assigned to placebo (RR= 0.57 [95% CI, 0.33 to 0.98]; P=0.015). In the warfarin group, 72% of the PT/INR tests were in therapeutic INR range. Only one patient required warfarin discontinuation and cross-over to placebo group due to gastrointestinal bleeding. CONCLUSIONS: These preliminary results showed that the anticoagulation therapy has been safe and reduced the frequency of venous thrombosis after transvenous cardiac devices implantation in high risk patients.


Assuntos
Anticoagulantes/farmacologia , Marca-Passo Artificial , Complicações Pós-Operatórias/prevenção & controle , Trombose Venosa/prevenção & controle , Varfarina/farmacologia , Administração Oral , Estimulação Cardíaca Artificial , Métodos Epidemiológicos , Feminino , Humanos , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/sangue , Medição de Risco , Trombose Venosa/sangue
16.
Arq Bras Cardiol ; 88(1): 31-4, 2007 Jan.
Artigo em Inglês, Português | MEDLINE | ID: mdl-17364115

RESUMO

OBJECTIVE: to compare the international normalized ratio (INR) measured by a point-of-care (POC) testing device with that measured by the conventional method in patients undergoing anticoagulation therapy with warfarin sodium. METHODS: The INR of 383 warfarin-treated patients (mean age: 56.5 years; 207 female) was measured in capillary blood using the Hemochron Jr. device and compared with that of venous plasma samples determined by the conventional method performed in a Coag-A-Mate analyzer. Results were evaluated globally and for the following subgroups: INR < 2.0, from 2.0 to 3.5, and > 3.5. RESULTS: Using both methods, the comparison between INR values yielded a correlation coefficient (r) of 0.86. However, mean differences in INR in both tests, considering the three subgroups, proved to be statistically significant (p <0.001): 0.14 +/- 0.21 (INR< 2.0); 0.54 +/- 0.31 (2.0 < or = INR < or = 3.5), and 1.64 +/- 1.10 (INR> 3.5). Paired Students t-test analysis revealed a p value < 0.001 for the three subgroups studied. CONCLUSION: The use of point-of-care testing for monitoring oral anticoagulation has some limitations. Anticoagulation intensity was underestimated by this method in the three subgroups studied.


Assuntos
Anticoagulantes/uso terapêutico , Coagulação Sanguínea/efeitos dos fármacos , Heparina de Baixo Peso Molecular/uso terapêutico , Coeficiente Internacional Normatizado/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Tempo de Protrombina , Valores de Referência , Reprodutibilidade dos Testes
17.
Arq. bras. cardiol ; 88(1): 31-34, jan. 2007. tab, graf
Artigo em Português | LILACS | ID: lil-443639

RESUMO

OBJETIVO: Comparar os resultados do índice de Normalização Internacional (INR) obtidos pelo teste rápido com os do método convencional nos pacientes em terapia de anticoagulação oral com varfarina sódica. MÉTODOS: Para 383 pacientes tratados com varfarina (idade média: 56,5 anos; 207 mulheres), o INR foi determinado em sangue capilar pelo equipamento Hemochron Jr. e comparado com os resultados de amostras de plasma venoso analisadas pelo teste convencional realizado em equipamento Coag-A-Mate. Foram avaliados os resultados do desempenho global das amostras e dos seguintes subgrupos: INR < 2,0, entre 2,0 a 3,5 e > 3,5. RESULTADOS: A comparação entre os valores de INR dos dois métodos resultou em um coeficiente de correlação (r) de 0,86. Entretanto, a análise das diferenças médias entre os resultados dos dois testes, considerando os três subgrupos, apresentou diferenças estatisticamente significativas (p < 0,001): 0,14 ± 0,21 (INR < 2,0); 0,54 ± 0,31 (2,0 < INR < 3,5) e 1,64 ± 1,10 (INR> 3,5). O cálculo do teste t-pareado de Student resultou em um p < 0,001 para os três subgrupos analisados. CONCLUSÃO: A adoção do teste rápido para monitoramento da anticoagulação oral apresenta restrições. Esse método subestimou a intensidade da anticoagulação nos três subgrupos estudados.


OBJECTIVE: to compare the international normalized ratio (INR) measured by a point-of-care (POC) testing device with that measured by the conventional method in patients undergoing anticoagulation therapy with warfarin sodium. METHODS: The INR of 383 warfarin-treated patients (mean age: 56.5 years; 207 female) was measured in capillary blood using the Hemochron Jr. device and compared with that of venous plasma samples determined by the conventional method performed in a Coag-A-Mate analyzer. Results were evaluated globally and for the following subgroups: INR < 2.0, from 2.0 to 3.5, and > 3.5. RESULTS: Using both methods, the comparison between INR values yielded a correlation coefficient (r) of 0.86. However, mean differences in INR in both tests, considering the three subgroups, proved to be statistically significant (p <0.001): 0.14 ± 0.21 (INR< 2.0); 0.54 ± 0.31 (2.0 < INR < 3.5), and 1.64 ± 1.10 (INR> 3.5). Paired StudentÆs t-test analysis revealed a p value < 0.001 for the three subgroups studied. CONCLUSION: The use of point-of-care testing for monitoring oral anticoagulation has some limitations. Anticoagulation intensity was underestimated by this method in the three subgroups studied.


Assuntos
Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Anticoagulantes/uso terapêutico , Coagulação Sanguínea/efeitos dos fármacos , Heparina de Baixo Peso Molecular/uso terapêutico , Coeficiente Internacional Normatizado/métodos , Tempo de Protrombina , Valores de Referência , Reprodutibilidade dos Testes
18.
Rev. Soc. Cardiol. Estado de Säo Paulo ; 16(4): 287-294, out.-dez. 2006.
Artigo em Português | LILACS | ID: lil-456270

RESUMO

A melhora do conhecimento dos mecanismos de ação dos anticoagulantes, de sua eficácia e de sua segurança tem levado ao aumento progressivo do número de pacientes anticoagulados. A anticoagulação pode ser indicada tanto para prevenção de eventos tromboembólicos nos portadores de fibrilação atrial ou prótese cardíaca mecânica como para tratamento após evento trombótico agudo. Com o evidente aumento do número de pacientes anticoagulados, a ocorrência de eventuais necessidades curúrgicas nesses pacientes tem sido cada vez mais frequente. Diante desas situações de maior risco, será fundamental o preparo do paciente. A conduta deverá ser individualizada e levará em considerações dois aspectos fundamentais: risco trombótico do paciente e risco hemorrágico do procedimento. OS pacientes que serão submetidos a procedimento de alto risco hemorrágico deverão ter sua anticoagulação revertida, porém a reversão da anticoagulação poderá expor o paciente a alto risco trombótico. Acompanhamento multiprofissional com a indicação de medicamentos que atuam de forma...


Assuntos
Masculino , Feminino , Humanos , Anticoagulantes/administração & dosagem , Fator VIIa , Vitamina K/uso terapêutico , Hemostasia/fisiologia , Fatores de Risco
19.
Bull Acad Natl Med ; 188(8): 1377-93; discussion 1393-6, 2004.
Artigo em Francês | MEDLINE | ID: mdl-15918665

RESUMO

The risk of venous thromboembolism (VTE) in pregnant women with heterozygous factor V Leiden and/or heterozygous factor II 20210A gene mutations is poorly documented, and the need for prophylaxis is therefore controversial. We retrospectively studied 208 women with hereditary thrombophilia (heterozygous FV Leiden and/or factor II gene mutations), who had a total of 406 full-term pregnancies, including 10 with thromboprophylaxis. The ante- and post-partum incidence of VTE was significantly higher in women with both mutations (17.8 %) than in women with FII gene mutation alone (6.2%) p = 0.003. In contrast, there was no significant difference between women with FV+FII mutation and those with FV mutations alone (10%). Thus, the two most common hereditary risk factors for thrombophilia seem to have an additive rather than a synergistic effect on the antepartum/post-partum risk of VTE. In contrast, a previous history of VTE before pregnancy in women with both the FV and the FII gene mutations was associated with a very high risk of VTE (50%). The incidence of VTE was higher during the post-partum period than the ante-partum period. There was no significant difference in the incidence of fetal loss in the three groups, but this was not a primary endpoint. These results, obtained in a single center, have implications for VTE prophylaxis. Routine use of LMWH is not indicated during pregnancy in asymptomatic women with a single mutation. In contrast, it is justified throughout pregnancy in women with both mutations and a history of venous thrombosis. Regarding asymptomatic women with both mutations, the need for prophylaxis during part or all of the pregnancy should be weighed up on an individual basis. In the post-partum period, there is a consensus on the use of LMWH for 6 weeks in women with single or dual mutations associated with thrombophilia.


Assuntos
Fator V/genética , Complicações na Gravidez , Protrombina/genética , Trombose Venosa/etiologia , Trombose Venosa/genética , Adolescente , Análise Mutacional de DNA , Feminino , Fibrinolíticos/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Gravidez , Estudos Retrospectivos , Fatores de Risco
20.
Br J Haematol ; 123(2): 327-34, 2003 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-14531916

RESUMO

The risk of venous thromboembolism (VTE) in the absence of prophylaxis was evaluated in a retrospective study of 47 women (84 pregnancies) with combined thrombophilia [heterozygous factor V Leiden (FVL) plus prothrombin (FII) 20210A mutation (group I)] and in 82 women (193 pregnancies) with the FII alone (group II). VTE was more frequent in group I than in group II [17.8% versus 6.2%, P = 0.003, relative risk (RR) 2.9, 95% confidence interval (CI) 1.4-5.9], ante partum (7.1% and 2.1%) and post partum (11.5% and 4.2%). The risk was higher in index cases than in family members (RR 2.5, 95% CI 1.2-5.2 and RR 2.1, 95% CI 0.2-22.3 respectively) Even women who had no history of VTE before pregnancy had an increased risk (RR 2.2, 95% CI 1.0-4.8). Our results suggest that, during ante partum, prophylaxis is indicated in women with combined thrombophilia and with a VTE before pregnancy. In those without VTE before pregnancy, prophylaxis might be decided for each individual case, taking into consideration all risk factors. In women with the FII mutation alone, the low risk may not justify prophylaxis in the absence of previous VTE. In post partum, prophylaxis is indicated in all cases.


Assuntos
Fator V/genética , Mutação , Complicações Cardiovasculares na Gravidez , Protrombina/genética , Trombose Venosa/genética , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Feminino , Heparina/uso terapêutico , Heterozigoto , Humanos , Pessoa de Meia-Idade , Gravidez , Complicações Cardiovasculares na Gravidez/prevenção & controle , Cuidado Pré-Natal/métodos , Estudos Retrospectivos , Medição de Risco , Tromboembolia/genética , Tromboembolia/prevenção & controle , Trombose Venosa/prevenção & controle
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