RESUMO
PURPOSE: Beroctocog alfa is a second generation recombinant factor VIII manufactured by removing the B-domain from factor VIII. This prospective clinical trial was conducted to evaluate the efficacy, safety, and pharmacokinetics of beroctocog alfa in patients of ages > or =12 years previously treated for severe hemophilia A. MATERIALS AND METHODS: Seventy subjects received beroctocog alfa as an on-demand treatment for acute hemorrhage. RESULTS: The final hemostatic effect was excellent in 35 subjects (50%) and good in 26 subjects (37.1%). The drug showed an overall efficacy rate of 87.1%. The majority of acute hemorrhages was treated by administering the study drug once (86.2%) or twice (10.0%), and the mean dose administered per single infusion was 28.55+/-6.53 IU/kg. Ten subjects underwent 12 surgical procedures, and hemostatic efficacy was excellent in seven cases (58.3%) and good in five cases (41.7%), showing a 100% efficacy rate. A total of 52 of 88 subjects (59.0%) experienced 168 adverse events. There were 18 serious adverse events (10.7%) in 11 subjects, and two (mild dyspnea and facial edema) in one subject were related to the study drug. Only one subject formed a de novo factor VIII inhibitor, for an occurrence rate of 1.4% (one-sided 95% upper confidence limit: 3.85%). The final elimination half-life was 13.3 h and 12.6 h at baseline and 6 months after administration, respectively. CONCLUSION: Our results suggest that beroctocog alfa is safe and efficacious as either an on-demand treatment for acute hemorrhage or a surgical prophylaxis in patients with hemophilia A.
Assuntos
Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Produtos para o Consumidor , Dispneia , Fator VIII/efeitos adversos , Hemofilia A/tratamento farmacológico , Hemorragia/prevenção & controle , Hemostasia , Hemostasia Cirúrgica/métodos , Estudos Prospectivos , Proteínas Recombinantes/efeitos adversos , Resultado do TratamentoAssuntos
Humanos , Feminino , Gravidez , Antígenos , Fator VIII/efeitos adversos , Tromboembolia Venosa , Fatores de RiscoRESUMO
El presente estudio es descriptivo, de serie de casos, realizados en Cruz Roja Nicaragüense en el período comprendido del 01 de septiembre al 31 de diciembre del 2000. Siendo la muestra 50 pacientes que pertenecen al Programa de Hemofilia de Cruz Roja Nicaragüense y que cumplierón los críterios de inclusión teniendo como objetivo general determinar la cuantificación del factor VIII en pacientes hemofílicos menores de 17 años en el período de estudio. A estos pacientes se les aplicó un instrumento de recolección de datos, investigándoseles algunas características epidemiológicas, manifestaciones clínicas desde el inicio de su enfermedad así como pruebas de laboratorio para conocer la severidad de la Hemofilia y las enfermedades infecciosas adquiridas por el uso de hemoderivados. Los pacientes estudiados la mayoría residen en la capital, la edad que más predominó fue entre 5 a 9 años. El comportamiento familiar se caracterizópor tener gran cantidad de personas afectadas. La mayoría de los pacientes se clasificaron como Hemofilia moderada teniendo como signo inicial más frecuente el hematoma, y la hemartrosis como la manifestación más frecuente durante toda la enfermedad. La Hepatitis C fue la única enfermedad infecciosa adquiridad por el uso de hemoderivados presentándose con mayor frecuencia a los que se les transfundió más de 3000 unidades...
Assuntos
Coagulação Sanguínea , Transfusão de Sangue , Criança , Dissertações Acadêmicas como Assunto , Fator VIII/efeitos adversos , Hemofilia A , Hemostáticos , NicaráguaRESUMO
Results of a HIV prevalence study conducted in hemophiliacs from Belo Horizonte, Brazil are presented. History of exposure to acellular blood components was determined for the five year period prior to entry in the study, which occurred during 1986 and 1987. Patients with coagulations disorders (hemophilia A = 132, hemophilia B = 16 and coagulation disorders other than hemophilia = 16) were transfused with liquid cryoprecipitate, locally produced, lyophilized cryoprecipitate, imported from Säo Paulo (Brazil) and factor VIII and IX, imported from Rio de Janeiro (Brazil), Europe, and United States. Thirty six (22%) tested HIV seropositive. The univariate and multivariate analysis (logistic model) demonstrated that the risk of HIV infection during the study period was associated with the total units of acellular blood components transfused. In addition, the proportional contribution of the individual components to the total acellular units transfused, namely a increase in factor VIII/IX and lyophilized cryoprecipitate proportions, were found to be associated with HIV seropositivity. This analysis suggest that not only the total amount of units was an important determinant of HIV infection, but that the risk was also associated with the specific component of blood transfused