RESUMO
The safety and efficacy of granisetron (10 micrograms/kg and 40 micrograms/kg) were evaluated during a second (n = 393) and third (n = 200) cycle of chemotherapy in this multicenter, double-blind, randomized, parallel-group study. Granisetron was administered as a single intravenous dose before the start of cisplatin chemotherapy (> or = 60 mg/m2). Total control (no vomiting, no retching, no nausea, and no use of antiemetic rescue medication) after the first 24 hr following chemotherapy was achieved in 40% and 49% of patients in Cycles 2 and 3, respectively, for the 10 micrograms/kg group, and in 42% and 38% of patients in Cycles 2 and 3, respectively, for the 40 micrograms/kg group. Both dose levels of granisetron were well tolerated. The results demonstrate comparable efficacy between the 10 micrograms/kg and 40 micrograms/kg doses of granisetron in preventing nausea and vomiting during repeat cycles of high-dose cisplatin-based chemotherapy. The results of this study show that granisetron 10 micrograms/kg is safe and well tolerated, and remains effective with repeat cycle use.
Assuntos
Antieméticos/uso terapêutico , Antineoplásicos/uso terapêutico , Cisplatino/efeitos adversos , Granisetron/uso terapêutico , Náusea/tratamento farmacológico , Vômito/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Antieméticos/administração & dosagem , Antineoplásicos/efeitos adversos , Método Duplo-Cego , Avaliação de Medicamentos , Feminino , Granisetron/administração & dosagem , Granisetron/efeitos adversos , Humanos , Injeções Intravenosas , Masculino , Pessoa de Meia-Idade , Náusea/induzido quimicamente , Vômito/induzido quimicamenteAssuntos
Antieméticos/uso terapêutico , Antineoplásicos/efeitos adversos , Dronabinol/análogos & derivados , Vômito/tratamento farmacológico , Adolescente , Adulto , Idoso , Envelhecimento , Ensaios Clínicos como Assunto , Método Duplo-Cego , Dronabinol/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Placebos , Fatores Sexuais , Vômito/induzido quimicamenteRESUMO
Eleven patients with leukemia and lymphoma were treated with 14 courses of E. coli L-asparaginase. Abnormalities of the coagulation screening tests and decreased fibrinogen levels were observed in all patients during treatment. Significant depressions of functional (mean 32%) and antigenic (mean 48%) antithrombin III were observed by day 14 of therapy. There was no laboratory evidence of intravascular coagulation during 11/14 courses of L-asparaginase. Crossed immunoelectrophoresis of plasma obtained at the antithrombin nadir did not demonstrate an abnormal pattern which can be associated with an abnormal antithrombin III or an increase in antithrombin III-coagulation factor complexes. The major underlying mechanism of this depression is believed to be decreased hepatic synthesis, and the low levels of antithrombin III may be associated with an increased risk of thrombosis.
