RESUMEN
The effects of tiagabine (TGB) on abilities and on adjustment and mood are as yet incompletely understood. These effects were compared with those of phenytoin (PHT) and carbamazepine (CBZ) in an add-on study. Patients included in the analysis were adults with uncontrolled partial seizures who at study entry were on CBZ alone (n=153) or on PHT alone (n=124). Of the patients receiving CBZ, 82 were randomized to add-on TGB and 71 were randomized to add-on PHT during the double-blind period. Of the patients receiving PHT, 58 were randomized to add-on TGB and 66 were randomized to add-on CBZ. Eight tests of mental abilities and three of mood and adjustment were given prior to assignment of add-on treatment and after up to 16 weeks of add-on treatment. For the baseline CBZ group, analyses were done to search for differential changes from baseline in the test scores of the add-on TGB and add-on PHT groups, and for the baseline PHT group in the add-on TGB and add-on CBZ groups. In the baseline CBZ group, no differences in test scores were found between PHT and TGB. In the baseline PHT group for the area of abilities, patients treated with TGB had improved verbal fluency, as well as quicker responses on a test of perceptual/motor speed compared with patients treated with CBZ. For the baseline PHT group in the area of adjustment and mood, patients treated with TGB reported less positive mood and more financial concerns compared to patients treated with CBZ. Overall, add-on TGB showed few or no differences in comparison with add-on CBZ and add-on PHT.
Asunto(s)
Anticonvulsivantes/farmacología , Carbamazepina/farmacología , Epilepsia Parcial Compleja/psicología , Ácidos Nipecóticos/farmacología , Fenitoína/farmacología , Adaptación Psicológica/efectos de los fármacos , Adulto , Afecto/efectos de los fármacos , Anticonvulsivantes/uso terapéutico , Carbamazepina/uso terapéutico , Cognición/efectos de los fármacos , Método Doble Ciego , Epilepsia Parcial Compleja/tratamiento farmacológico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Ácidos Nipecóticos/uso terapéutico , Fenitoína/uso terapéutico , Estadísticas no Paramétricas , TiagabinaRESUMEN
PURPOSE: We evaluated the dose-related impacts of tiagabine (TGB) on cognition and mood in a monotherapy study. METHODS: Patients were 123 adults with uncontrolled partial seizures, each treated with a single currently available antiepileptic drug (AED) for management of clinical epilepsy. They completed a battery of neuropsychological tests during an 8-week prospective baseline period and once again at the end of the 12-week fixed-dose period (or earlier if they dropped out of the study). Sixty-six patients were randomized to 6 mg/day TGB and 57 were randomized to 36 mg/day TGB. RESULTS: Few changes in either abilities or adjustment and mood were noted when all patients were considered as a single group. However, analysis of both dose and attainment of TGB monotherapy showed that patients receiving TGB monotherapy did best, improving particularly in the areas of adjustment and mood with low-dose TGB and in the area of abilities with high-dose TGB. Patients who did not attain monotherapy showed no change except that the high-dose group did not perform as well on measures of mood and adjustment. Baseline AED and changes in seizure control did not affect the results. CONCLUSIONS: Patients' attainment of TGB monotherapy was associated with their achievement of positive changes of varying degree on psychological tests. Failure to attain TGB monotherapy was associated with no changes on the tests except in patients receiving high-dose TGB where it appeared that some alterations in mood might have been avoided if a slower titration schedule had been used.
Asunto(s)
Afecto/efectos de los fármacos , Anticonvulsivantes/farmacología , Anticonvulsivantes/uso terapéutico , Cognición/efectos de los fármacos , Epilepsia/tratamiento farmacológico , Ácidos Nipecóticos/farmacología , Ácidos Nipecóticos/uso terapéutico , Adolescente , Adulto , Anticonvulsivantes/administración & dosificación , Escalas de Valoración Psiquiátrica Breve , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Esquema de Medicación , Femenino , Humanos , Masculino , Pruebas Neuropsicológicas/estadística & datos numéricos , Ácidos Nipecóticos/administración & dosificación , Inventario de Personalidad , Desempeño Psicomotor/efectos de los fármacos , Calidad de Vida , Ajuste Social , Tiagabina , Resultado del TratamientoRESUMEN
The maximum solubilities of calcium and phosphate in neonatal total parenteral nutrient (TPN) solutions compounded using Aminosyn-PF or TrophAmine amino acid injection were determined. Eight solutions were compounded from Sterile Water for Injection, USP, 50% dextrose injection, usual electrolytes and trace metals, and Aminosyn-PF 7% or TrophAmine 6% to obtain concentrations of amino acids 2.5% and dextrose 25% and amino acids 1% and dextrose 10%. Cysteine hydrochloride was added to half of the solutions at a concentration of 40 mg/g of protein. The pH of each solution was determined at various times during admixture preparation. The solutions were divided into 20-mL aliquots, and phosphate and calcium were added to each aliquot at concentrations of 2.5 to 50 meq/L of calcium and 5 to 50 mmol/L of phosphate. All solutions were inspected visually for signs of precipitation or crystallization after 18 hours of storage at room temperature and again after 30 minutes in a 37 +/- 1 degrees C water bath. Samples with no visible signs of precipitation were filtered, and the filter membrane was inspected under a microscope. Solubility curves were prepared by plotting the concentrations of calcium and phosphate at which either visual or microscopic precipitation occurred. Calcium and phosphate solubility was greater in the solutions with higher concentrations of amino acids and dextrose. In contrast to the results of some previous studies, no important differences in calcium and phosphate solubility were observed between Aminosyn-PF and TrophAmine in solutions containing amino acid concentrations of 2.5%, with or without added cysteine hydrochloride.(ABSTRACT TRUNCATED AT 250 WORDS)