RESUMO
PURPOSE: Fibrinolytic therapy restores coronary patency and reduces mortality in patients with acute myocardial infarction. Albumin is present in most of the streptokinase formulation as a stabilizer but it is not known whether it plays a role in the product's efficacy and safety profiles. The aim of this study was to assess 90 minutes-coronary patency of a new albumin-free recombinant streptokinase (rSK) formulation. METHODS . Patients with ischemic chest pain and ST-segment elevation, less than 12 hours after symptoms onset, without contraindications for fibrinolytic therapy, were included to receive 1.5 x 10(6) IU of rSK in a one-hour intravenous infusion. Angiography was performed 90 minutes after and coronary patency was classified according to the TIMI flow scales. RESULTS: The study enrolled 25 patients, 59.4 +/- 9.2 years-old, 88% men and 92% white. The mean time interval between the symptoms onset and rSK infusion was 3.0 +/- 2.0 hours. Patency rate (TIMI 2-3) of the infarct-related vessel was 72% (18/25). Partial or complete ST-segment resolution was achieved in 17 patients (68%). Hypotension and nauseas were the most frequent adverse events. Haemorrhage or in-hospital deaths were not reported. CONCLUSIONS: This study suggests that intravenous albumin-free rSK is a safe and appropriate therapy to get early (90-minute) coronary patency in patients with acute myocardial infarction.
Assuntos
Infarto do Miocárdio/tratamento farmacológico , Estreptoquinase/uso terapêutico , Doença Aguda , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Estreptoquinase/efeitos adversos , Terapia Trombolítica , Resultado do Tratamento , Grau de Desobstrução Vascular/efeitos dos fármacosRESUMO
INTRODUCCIÓN. La artritis idiopática juvenil (AIJ) es una enfermedad del colágeno caracterizada por sinovitis crónica y síntomas extraarticulares, de inicio antes de los 16 años de edad. El interferón gamma (INFγ) mostró eficacia en un ensayo anterior con pacientes resistentes o intolerantes a las otras terapias disponibles, por lo que se decidió evaluar su eficacia y seguridad como medicamento modificador de la evolución de esta enfermedad. MÉTODOS. Se realizó un ensayo clínico abierto, no controlado, en el que se administró INFγ por vía intramuscular en dosis de 50 000 UI/kg (hasta 1 x 10(6) UI) durante 2 años. En el ensayo se incluyeron 20 pacientes con AIJ: 5 tenían la forma pauciarticular; 9, la poliarticular y 6, la sistémica. RESULTADOS. Al final del tratamiento, 13 pacientes (65 por ciento) se evaluaron como respondedores. El número de articulaciones afectadas, los síntomas sistémicos y los valores de eritrosedimentación y del cuestionario de calidad se redujeron significativamente. Igualmente disminuyó el número de pacientes que continuó consumiendo esteroides, así como la dosis de éstos. El tratamiento fue bien tolerado, excepto en 2 pacientes. CONCLUSIONES. El INFγ disminuye la expresión de la quimiocina CCR-4 en los niños, pero no en los adultos con la enfermedad. Es posible concluir que esta citocina puede ser una alternativa terapéutica eficaz en pacientes con AIJ; para confirmarlo se necesitan estudios controlados más extensos(AU)
INTRODUCTION: The juvenile idiopathic arthritis (JIA) is a collagen entity characterized by chronic synovitis and extra-articulation symptoms appearing before the 16 years old. Gamma Interferon (gamma-INF) showed its effectiveness in a prior trial with resistant and intolerant patients to other available gamma-INF therapies, thus authors assessed its effectiveness and safety as a modifier drug of the course of this entity. METHODS: An open clinical, no-controlled trial was carried out administering gammaINF by intramuscular route in doses of 50 000 IU/kg (up to 1 x 10(6) IU) during two years. Trial included 20 patients with JIA: five had the pauciarticular type; nine had the polyarticular one and six had the systemic one. RESULTS: At treatment termination, 13 patients (65 percent) were assessed as respondents. Figure of involved joints, the systemic symptoms and the erythrosedimentation values, and the quality questionnaire significantly decreased, as well as the figure of patients to continue consuming steroids and its dosage. Treatment was well tolerated, except 2 patients. CONCLUSIONS: Gamma-INF decrease the expression of CCR-4 chemokine in children, but not in adults ones presenting this entity. We conclude that this cytokine may be an efficient therapeutical alternative in patients with JIA; for its confirmation it is necessary more extent controlled studies(AU)
Assuntos
Humanos , Adolescente , Artrite Juvenil/diagnóstico , Interferon gama/uso terapêuticoRESUMO
INTRODUCCIÓN. La artritis idiopática juvenil (AIJ) es una enfermedad del colágeno caracterizada por sinovitis crónica y síntomas extraarticulares, de inicio antes de los 16 años de edad. El interferón gamma (INFγ) mostró eficacia en un ensayo anterior con pacientes resistentes o intolerantes a las otras terapias disponibles, por lo que se decidió evaluar su eficacia y seguridad como medicamento modificador de la evolución de esta enfermedad. MÉTODOS. Se realizó un ensayo clínico abierto, no controlado, en el que se administró INFγ por vía intramuscular en dosis de 50 000 UI/kg (hasta 1 x 10(6) UI) durante 2 años. En el ensayo se incluyeron 20 pacientes con AIJ: 5 tenían la forma pauciarticular; 9, la poliarticular y 6, la sistémica. RESULTADOS. Al final del tratamiento, 13 pacientes (65 por ciento) se evaluaron como respondedores. El número de articulaciones afectadas, los síntomas sistémicos y los valores de eritrosedimentación y del cuestionario de calidad se redujeron significativamente. Igualmente disminuyó el número de pacientes que continuó consumiendo esteroides, así como la dosis de éstos. El tratamiento fue bien tolerado, excepto en 2 pacientes. CONCLUSIONES. El INFγ disminuye la expresión de la quimiocina CCR-4 en los niños, pero no en los adultos con la enfermedad. Es posible concluir que esta citocina puede ser una alternativa terapéutica eficaz en pacientes con AIJ; para confirmarlo se necesitan estudios controlados más extensos
INTRODUCTION: The juvenile idiopathic arthritis (JIA) is a collagen entity characterized by chronic synovitis and extra-articulation symptoms appearing before the 16 years old. Gamma Interferon (gamma-INF) showed its effectiveness in a prior trial with resistant and intolerant patients to other available gamma-INF therapies, thus authors assessed its effectiveness and safety as a modifier drug of the course of this entity. METHODS: An open clinical, no-controlled trial was carried out administering gammaINF by intramuscular route in doses of 50 000 IU/kg (up to 1 x 10(6) IU) during two years. Trial included 20 patients with JIA: five had the pauciarticular type; nine had the polyarticular one and six had the systemic one. RESULTS: At treatment termination, 13 patients (65 percent) were assessed as respondents. Figure of involved joints, the systemic symptoms and the erythrosedimentation values, and the quality questionnaire significantly decreased, as well as the figure of patients to continue consuming steroids and its dosage. Treatment was well tolerated, except 2 patients. CONCLUSIONS: Gamma-INF decrease the expression of CCR-4 chemokine in children, but not in adults ones presenting this entity. We conclude that this cytokine may be an efficient therapeutical alternative in patients with JIA; for its confirmation it is necessary more extent controlled studies