Comparative bioavailability evaluation of two cyclosporine oral formulations in healthy mexican volunteers

Background. The use of conventional cyclosporine (Sandimmune) requires great care, as this drug exhibits a narrow therapeutic index and wide interindividual variability in its Pharmacokinetics. Recently, a new microemulsion formulation (Neoral) was developed. With this formulation, cyclosporine is absorbed at the small intestine without the presence of bile. Therefore. The objective of this study was to compare the bioavailability of cyclosporine after the administration of conventional and microemulsion formulations in healthy Mexican volunteers in order to approach the optimal dosage regimen of microemulsion in the Mexican population. Methods. The trial was conducted using 23 healthy volunteers according to a randomized crossover design. Volunteers received on 7.5-mg/kg dose as each formulation, with a 1-week washout period between treatment. Blood samples of 0.5 mL were obtained according to the following schedule. 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 h after medication. Results. These indicated that Cmax and AUC0-24 values were higher with the microemulsion than with the conventional formulation. Conclusions. The microemulsion had a better absorption profile than the conventional formulation, because plasma levels with the conventional formulation demostrated oscilations rather than reflecting an erratic absorption. Lower doses of the microemulsion are required to obtain Cmax values similar tho those obtained with conventional cyclosporine

Tratamiento paliativo del dolor óseo con samario 153-EDTMP en cáncer prostático metastásico: estudio controlado / Palliative pain treatment by means of samarium 143-EDTMP in metastatic prostate cancer: a controled study

Se realizó un ensayo clínico controlado, prospectivo, longitudinal, comparativo y experimental que abarcó el periodo comprendido entre el 26 de septiembre de 1995 y el 27 de marzo de 1996, con 18 pacientes de cáncer prostático metastásico que cursaban con dolor óseo refractario por actividad tumoral. De los 18 pacientes, a nueve se les aplicó el fármaco radiactivo samario 153 como terapia analgésica, y los otros nueve continuaron con el tratamiento analgésico ordinario (grupo testigo). Los resultados muestran una disminución significativa de la intensidad del dolor en los pacientes tratados con samario 153 en comparación con lo observado en los pacientes del grupo testigo. Se concluye que el samario puede ser un agente terapéutico útil para la paliación del dolor óseo que generalmente es refractario a la terapéutica analgésica convencional, lo que se traduce en una mejoría en la calidad de vida de los pacientes con cáncer prostatico en etapa avanzada.