Quando o jogador de futebol Serginho do São Caetano morreu em campo em 2004, na manhã seguinte o lobby dos vendedores desfibriladores para reverter arritmias cardíacas tomou de assalto a imprensa na tentativa de mostrar que uma vida seria salva com esse equipamento. Leis locais foram promulgadas obrigando a compra do equipamento em próprios municipais.
Agora há uma enorme chance de chegar a Brasília, uma proposta fantástica que seria a do SUS disponibilizar vários medicamentos para sepse. Alguns, poderão ter um futuro como a alfadrotrecogina. Mas, a revisão abaixo transcrita mostra a necessidade de novos estudos. O custo de adotar esse medicamento seria de quase um bilhão de reais por ano a mais para o SUS em edição Boletim Brasileiro de Avaliação em Tecnologia de Saúde: alfadrotrecogina para o tratamento da sepse grave.
Nota importante: a unidade de terapia do Hospital Universitário da USP faz parte de estudo multicêntrico testando a alfadrotrecogina patrocinado pela Ely Lilli.
Human recombinant activated protein C for severe sepsis.
Marti-Carvajal A; Salanti G; Cardona A
Human recombinant activated protein C for severe sepsis.
Martí-Carvajal A, Salanti G, Cardona AF.
Universidad de Carabobo, Departamento de Salud Pública, Centro Colaborador Venezolano de la Red Cochrane Iberoamericana, Valencia, Edo. Carabobo, Venezuela, 2001. amarti@uc.edu.ve
BACKGROUND: Sepsis is a common, expensive and frequently fatal condition. There is an urgent need for developing new therapies to further reduce severe sepsis-induced mortality. One of those approaches is the use of human recombinant activated protein C (APC). OBJECTIVES: We assessed the clinical effectiveness of APC for the treatment of patients with severe sepsis or septic shock. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2005, Issue 2); MEDLINE (1966 to 2005); EMBASE (1980 to 2005) and LILACS (1982 to 2005). We contacted researchers and organizations working in the field. We did not have any language restriction. SELECTION CRITERIA: We included randomized controlled trials (RCTs) assessing the effects of APC for severe sepsis in adults and children. We excluded studies on neonates. DATA COLLECTION AND ANALYSIS: We independently performed study selection, quality assessment and data extraction. We estimated relative risks (RR) for dichotomous outcomes. We measured statistical heterogeneity using I-squared (I(2)). We used a random-effects model. MAIN RESULTS: We included four studies involving 4911 participants (4434 adults and 477 paediatric patients). For 28-day mortality, APC did not reduce the risk of death in adult participants with severe sepsis (pooled RR 0.92, 95% confidence interval (CI) 0.72 to 1.18; P = 0.50, I(2) = 72%). The effectiveness of APC did not seem to be associated with the degree of severity of sepsis (two studies): for an APACHE II score less than 25 the RR was 1.04 (95% CI 0.89 to 1.21; P = 0.70), and in participants with an APACHE II score of 25 or more the RR was 0.90 (95% CI 0.54 to 1.49; P = 0.68). APC use was, however, associated with a higher risk of bleeding (RR 1.48 (95% CI 1.07 to 2.06; P = 0.02, I(2) = 8%). Two studies were stopped early because there was little chance of reaching the efficacy endpoint by completion of the trial. AUTHORS' CONCLUSIONS: This updated review found no evidence suggesting that APC should be used for treating patients with severe sepsis or septic shock. Additionally, APC seems to be associated with a higher risk of bleeding. Unless additional RCTs provide evidence of a treatment effect, policy-makers, clinicians and academics should not promote the use of APC.
Marti-Carvajal A; Salanti G; Cardona A
Human recombinant activated protein C for severe sepsis.
Martí-Carvajal A, Salanti G, Cardona AF.
Universidad de Carabobo, Departamento de Salud Pública, Centro Colaborador Venezolano de la Red Cochrane Iberoamericana, Valencia, Edo. Carabobo, Venezuela, 2001. amarti@uc.edu.ve
BACKGROUND: Sepsis is a common, expensive and frequently fatal condition. There is an urgent need for developing new therapies to further reduce severe sepsis-induced mortality. One of those approaches is the use of human recombinant activated protein C (APC). OBJECTIVES: We assessed the clinical effectiveness of APC for the treatment of patients with severe sepsis or septic shock. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2005, Issue 2); MEDLINE (1966 to 2005); EMBASE (1980 to 2005) and LILACS (1982 to 2005). We contacted researchers and organizations working in the field. We did not have any language restriction. SELECTION CRITERIA: We included randomized controlled trials (RCTs) assessing the effects of APC for severe sepsis in adults and children. We excluded studies on neonates. DATA COLLECTION AND ANALYSIS: We independently performed study selection, quality assessment and data extraction. We estimated relative risks (RR) for dichotomous outcomes. We measured statistical heterogeneity using I-squared (I(2)). We used a random-effects model. MAIN RESULTS: We included four studies involving 4911 participants (4434 adults and 477 paediatric patients). For 28-day mortality, APC did not reduce the risk of death in adult participants with severe sepsis (pooled RR 0.92, 95% confidence interval (CI) 0.72 to 1.18; P = 0.50, I(2) = 72%). The effectiveness of APC did not seem to be associated with the degree of severity of sepsis (two studies): for an APACHE II score less than 25 the RR was 1.04 (95% CI 0.89 to 1.21; P = 0.70), and in participants with an APACHE II score of 25 or more the RR was 0.90 (95% CI 0.54 to 1.49; P = 0.68). APC use was, however, associated with a higher risk of bleeding (RR 1.48 (95% CI 1.07 to 2.06; P = 0.02, I(2) = 8%). Two studies were stopped early because there was little chance of reaching the efficacy endpoint by completion of the trial. AUTHORS' CONCLUSIONS: This updated review found no evidence suggesting that APC should be used for treating patients with severe sepsis or septic shock. Additionally, APC seems to be associated with a higher risk of bleeding. Unless additional RCTs provide evidence of a treatment effect, policy-makers, clinicians and academics should not promote the use of APC.
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