RESUMO
A phase I clinical trial of the macrophage activator, muramyl tripeptide-phosphatidylethanolamine has been carried out in 37 patients (47 courses) at doses of 0.01-6.0 mg/m2 intravenously twice weekly for 4 weeks. Activation of peripheral blood monocytes and drug toxicity were used as the parameters to monitor the trial. Toxicity was acute systemic responses of fever, chills, and hypertension without a clear dose response. No major organ-related toxicity was seen. A dose of 4.0 mg/m2 biweekly produced activation of blood monocytes; a dose of 6.0 mg/m2 produced inhibition. There was one complete response of 3 months duration in a patient with renal cell carcinoma with pulmonary metastases. The optimum dose for phase II studies is in the range of 1-4 mg/m2 twice weekly for 4 weeks, a dose that is well tolerated.
Assuntos
Acetilmuramil-Alanil-Isoglutamina/análogos & derivados , Ativação de Macrófagos/efeitos dos fármacos , Neoplasias/tratamento farmacológico , Fosfatidiletanolaminas/administração & dosagem , Acetilmuramil-Alanil-Isoglutamina/administração & dosagem , Acetilmuramil-Alanil-Isoglutamina/efeitos adversos , Adolescente , Adulto , Idoso , Portadores de Fármacos , Avaliação de Medicamentos , Feminino , Humanos , Lipossomos , Masculino , Pessoa de Meia-Idade , Estrutura Molecular , Fosfatidiletanolaminas/efeitos adversos , Índice de Gravidade de DoençaRESUMO
A paraplegic patient presented with radiopaque suppositories mimicking recurrent calculi. An unnecessary cystotomy resulted.