[Study on the usage, effectiveness, and toxicity associated to treatment with sorafenib]. / Estudio de utilización, efectividad y toxicidad asociada al tratamiento con sorafenib.

OBJECTIVE: To know the usage, effectiveness, and toxicity associa ted to Sorafenib treatment in cancer patients at a general hospital. METHODS: Observational, retrospective, and longitudinal study on the usage, effectiveness and toxicity associated to Sorafenib. Cancer patients at a general university hospital initiating treatment with Sorafenib were included between January of 2007 and December of 2010, with an extended follow-up period up to June of 2012. RESULTS: 31 patients started the treatment (mean age 61.6 years; 67.7% males). 83.87% received a monotherapy regimen with fixed doses of 400 mg b.i.d., whereas 5 patients required dose adjustment due to poor gastrointestinal tolerance and skin toxicity. At the end of the study, 3 patients were still alive and kept on receiving the treatment, 27 withdrew from the therapy, and 1 pa - tient was lost to follow-up. The pathologies treated with Sorafenib were hepatocarcinoma (38.7%), advanced renal cancer (35.5%), melanoma (9.7%), thyroid cancer (12.9%), and gastrointestinal stromal tumor (3.2%). The median overall survival was 524 days for hepatocarcinoma and 217 days for renal cancer. Adverse reactions with Sorafenib were observed in 41.9% of the patients. CONCLUSIONS: This study reveals that Sorafenib is effective in patients with hepatocarcinoma and renal cancer, essentially depending on the baseline clinical status of the patients. Sorafenib may be associated with the occurrence of adverse events, mainly gastrointestinal and cutaneous, requiring dose adjustment and treatment withdrawal in some cases.

Objetivo: Conocer la utilización, efectividad y toxicidad asociada al tratamiento con sorafenib en los pacientes oncológicos de un hospital general. Métodos: Estudio observacional, retrospectivo y longitudinal de utilización, efectividad y toxicidad asociada a sorafenib. Se incluyeron los pacientes oncológicos de un hospital general universitario, que iniciaron tratamiento con sorafenib entre Enero 2007 y Diciembre 2010, ampliando el periodo de seguimiento hasta junio de 2012. Resultados: Iniciaron tratamiento 31 pacientes (edad media 61,6 años, 67,7% varones). En todos se utilizó un régimen de monoterapia, empleándose dosis fijas de 400 mg cada 12 horas en el 83,87%, mientras que 5 pacientes precisaron ajuste de dosis por mala tolerancia gastrointestinal y toxicidad cutánea. Al finalizar el estudio, 3 pacientes continuaban vivos y mantuvieron el tratamiento, 27 pacientes lo suspendieron y en 1 paciente se perdió el seguimiento. Las patologías tratadas con sorafenib fueron hepatocarcinoma (38,7%), cáncer renal avanzado (35,5%), melanoma (9,7%), caeacute;ncer de tiroides (12,9%) y tumor del estroma gastrointestinal (3,2%). La mediana de supervivencia global fue de 524 días para hepatocarcinoma y de 217 días para cáncer renal. Se observaron reacciones adversas a sorafenib en el 41,9% de los pacientes. Conclusiones: Este estudio revela que sorafenib es eficaz en los pacientes con hepatocarcinoma y cáncer renal, dependiendo fundamentalmente de la situación clínica inicial de los pacientes. Sorafenib es responsable de la aparición de efectos secundarios, fundamentalmente de tipo gastrointestinal y cutáneo, que requirieron ajuste de dosis y suspensión del tratamiento en algunos casos.

Effects of 2 lipid emulsions (LCT versus MCT/LCT) on the fatty acid composition of plasma phospholipid: a double-blind randomized trial.

BACKGROUND: Fatty acids from the diet or from IV fat emulsions are incorporated into the plasma and cell membrane phospholipids and act as substrates in the synthesis of eicosanoids. This study reports the effect of 2 parenteral lipid emulsions in plasma phospholipids fatty acids. METHODS: A total of 83 patients aged 18 to 75 years were randomized to receive long-chain triglycerides (LCT) or 50/50 mix of long- and medium-chain triglyceride emulsion (LCT/MCT). Blood samples were collected at baseline and at weekly intervals for 28 days. Plasma phospholipid fatty acids were measured by gas chromatography. RESULTS: Patients receiving LCT versus MCT/LCT emulsion have an increase in 18:2n6 and a decrease in 20:4n6 and 22:4n6 after 7, 14, and 21 days of treatment with parenteral nutrition. Phospholipid fatty acids at 15 days of treatment with parenteral nutrition with LCT versus MCT/LCT for 18:2n6 were 17.30% versus 22,90% (p < .05), for 20:4n6 10.44% versus 8.38% (p < .05), and for 22:4n6 0.51% versus 0.40% (p < .05). The 20:4n6 percentage inversely correlated with the percentage of 18:2n6 on days 7, 14, and 21: regression coefficients: -7.40 (p < .001), -7.39 (p < .001), and 5.70 (p < .001), respectively. CONCLUSIONS: Parenteral lipid emulsions modify fatty acid profiles in plasma phospholipids. MCT/LCT emulsions produce in phospholipids a fatty-acid profile that is closer to normality than that achieved with LCT emulsions. These changes in phospholipid fatty acids are suggestive of an inhibition of A-5-desaturase in patients who received LCT emulsions.

Utilización de antiinfecciosos en los hospitales españoles: evolución 1997-1999 / Use of antiinfectious agents at the spanish hospitals: evolution 1997-1999

Objetivo. Describir el perfil de utilización de antiinfecciosos en los hospitales españoles a partir de su consumo y analizar su evolución durante el periodo 1997-1999.Método. Estudio descriptivo, retrospectivo y multicéntrico, en el que participan voluntariamente los hospitales españoles. A través de un programa informático disponible en la página web de la sociedad, cada hospital introduce los datos de consumo de antiinfecciosos. El programa calcula los resultados en DDDs/100 estancias, que posteriormente son analizados de manera global, por tipo de hospital, vía de administración, grupo terapéutico y principio activo. Resultados. Participan en el estudio 32 hospitales en 1997, y 55 en 1998 y 1999. El consumo global de antimicrobianos en DDDs/100 estancias es de 97,45, 90,06 y 93,17 respectivamente. Existe una mayor utilización de antibióticos en hospitales con unidad de trasplantes. El uso de la vía parenteral predomina sobre la oral. El 80 por ciento del consumo corresponde a penicilinas, cefalosporinas, fluorquinolonas, macrólidos y aminoglucósidos, siendo amoxicilina-clavulánico el principio activo más consumido. Se detecta un incremento importante en el consumo de claritromicina, acompañado de un descenso en el uso de eritromicina (AU)

Influence of different intravenous infusion sets on temperature of refrigerated parenteral nutrition solutions.

We measured the temperature of 10 previously refrigerated parenteral-nutrition solutions (PN solutions) at the end of a standard intravenous-infusion set (IIS) (Intrafix, 145 cm long), an IIS with a mechanical device to control the flow of the solution (Dial-a-Flow, 226 cm long), and an IIS to be used with a volumetric infusion pump (Infusomat, 259 cm long). The temperature of the PN solution just after taking it out of the refrigerator was 6.0 +/- 0.8 degrees C (mean +/- SD), and that of the room was 24.2 +/- 0.7 degrees C. We recorded the temperature again at the end of the IIS after draining it freely, i.e., until there was no air inside the set (time 0), after 5, 10, and 15 min of infusion at 100 ml/h. After 15 min, the temperature at the end of the Intrafix set did not statistically differ (P less than 0.05) from room temperature. With Dial-a-Flow, the temperature of the solution was not statistically different from room temperature at any time. Finally, with Infusomat, the temperature was statistically different from that of the room for the first 5 min. We thus conclude that refrigerated PN solution can be administered to patients without having to warm it whenever an IIS is longer than 145 cm and flow not exceeding 100 ml/h is used. Adverse reactions sometimes observed in patients at the beginning of the administration of PN solution cannot, in our opinion, be attributed to the low temperature of the solution.

[Temperature of refrigerated parenteral nutrition solutions at the end of 2 infusion systems]. / Temperatura de las soluciones de nutrición parenteral refrigeradas al final de dos sistemas de infusión.

It is common practice to let parenteral nutrition bags that are kept refrigerated stand at room temperature before administration. In this study the temperature of the mixtures administration. In this study the temperature of the mixtures flowing at the end of a conventional system (Intrafix 145 cm long) and at the end of a flow-control system (Dial-a-flow 226 cm long) were measured. Mixture temperatures within the parenteral nutrition bag were recorded upon removal from the refrigerator, at the end of the infusion system after purging the system with the fastest flow rate possible (time 0), and at 5, 10, and 15 minutes, after sustaining continuous flow at 100 cc/hour. The conventional system showed no statistically significant differences (P less than 0.05) between room temperature (23.7 +/- 0.5) and mixture temperature at the end of the infusion line at 15 minutes of infusion (23.0 +/- 0.9). The Dial-a-flow system showed no statistically significant differences between room temperature (24.5 +/- 0.9) and mixture temperatures at the end of the system (time 0: 23.7 +/- 2.2; 5 minutes, 24.1 +/- 0.8; 10 minutes, 24.3 +/- 0.7; 15 minutes, 24.4 +/- 0.7) (p less than 0.05). Therefore, the results indicate that refrigerated parenteral nutrition bags can be administered directly to the patient without waiting for the mixture to warm up, anytime the length of the infusion system is over 145 cm. Occasional reactions observed at the onset of parenteral nutrition therapy cannot be attributed to low mixture temperature, and as such, other reasons must be searched for.