[Effectiveness and safety of 5-azacitidine in three patients with myelodysplastic syndromes]. / Efectividad y seguridad de 5-azacitidina en tres pacientes con síndrome mielodisplásico.

OBJECTIVE: To assess the effectiveness and safety of using 5-azacitidine to treat myelodysplastic syndromes. METHODS: Review of medical records of patients who received 5-azacitidine 75mg/m(2) subcutaneously for during 7 days every 28 days in twelve cycles as compassionate use. We evaluated the objective response, clinical improvement and time to disease progression. We recorded adverse reactions described in the medical history. RESULTS: Six patients were candidates for treatment with 5-azacitidine. Three cases were evaluated over the study period. Most remained in partial response or better after the study, and no longer needed transfusions. In one patient, the treatment appeared to delay progression to leukaemia. CONCLUSIONS: 5-Azacitidine might be considered an effective and relatively safe drug, and may have contributed to controlling peripheral cytopenias, improving the quality of life and delaying progression to leukaemia. Additional studies with more patients are needed to support these results.

[Pharmaceutical care for patients with enteral nutrition]. / Original breve Atención farmacéutica en pacientes con nutrición enteral.

OBJECTIVE: To detect potential complications and interactions between drugs and enteral nutrition (EN) as to describe the interventions carried out by the pharmacist in those circumstances and to propose strategies of improvement. METHOD: Prospective assessment of patients admitted to hospital candidates to receive EN. The pharmacist worked as part of the team of Endocrinology and Nutrition for one month. A data collection form was designed for the study in which the following information had to be recorded: NE indications, nutrition characteristics (type, route of administration, infusion rate), pharmacological therapy, drug/EN interaction and complications. RESULTS: The study included 14 patients (mean age of 50 +/- 13 years) in which digestive (35.7%) and neurological (28.6%) complications were the most frequent indications for EN. Eleven patients (78.57%) reported complications associated to EN, mostly digestive (57.14%). The main cause for consultation was related to the administration of drugs via NGT (nasogastric tube). A total of 77 drugs were prescribed, 23 of which were administered in this way, so a guidelines for the administration of drugs via nasogastric tube was prepared. CONCLUSIONS: The hospital pharmacist can actively cooperate with nutritional support units, given the need to assess the nutritional support administered and to manage potential complications and interactions between nutritional status, drugs and artificial nutrition. The pharmacist also plays a significant role in the prevention and identification of problems related to the administration of drugs via NGT.

Atención farmacéutica en pacientes con nutrición enteral / Pharmaceutical care for patients with enteral nutrition

Objetivo: Detectar las posibles complicaciones e interaccionesentre medicamentos-nutrición enteral (NE) y describir lasintervenciones realizadas por el farmacéutico en este entorno,proponiendo estrategias de mejora.Método: Evaluación prospectiva en pacientes ingresados en elhospital candidatos a recibir NE. El farmacéutico se integra en elequipo de Endocrinología y Nutrición durante 1 mes. Para el estudiodiseña un impreso de recogida de datos donde se especifica:indicación de NE, características de la nutrición (tipo, vía de administración,velocidad de infusión), tratamiento farmacológico, interaccionesmedicamento/NE y complicaciones.Resultados: Se incluyeron 14 pacientes (edad media 50 ± 13años) en los que las alteraciones digestivas (35,7%) y las neurológicas(28,6%) fueron las indicaciones más frecuentes de NE. Seprodujeron complicaciones asociadas a NE en 11 pacientes(78,57%) siendo las digestivas (57,14%) las más frecuentes. Elprincipal motivo de consulta estuvo relacionado con la administraciónde medicamentos por sonda nasogástrica (SNG), se pautaronun total de 77 medicamentos de los que 23 se administraron porésta vía, por lo que se elaboró una guía de administración de fármacospor sonda.Conclusiones: El farmacéutico de hospital puede colaboraractivamente en las unidades de soporte nutricional ya que es necesarioevaluar el aporte nutricional administrado y manejar las posiblescomplicaciones e interacciones entre el estado nutricional,medicamentos y nutrición artificial. Del mismo modo juega unpapel importante en la prevención y detección de los problemasrelacionados con la administración de medicamentos por SNG

Objective: To detect potential complications and interactionsbetween drugs and enteral nutrition (EN) as to describe the interventionscarried out by the pharmacist in those circumstances andto propose strategies of improvement.Method: Prospective assessment of patients admitted to hospitalcandidates to receive EN. The pharmacist worked as part ofthe team of Endocrinology and Nutrition for one month. A datacollection form was designed for the study in which the followinginformation had to be recorded: NE indications, nutrition characteristics(type, route of administration, infusion rate), pharmacologicaltherapy, drug/EN interaction and complications.Results: The study included 14 patients (mean age of 50 ±13 years) in which digestive (35.7%) and neurological (28.6%)complications were the most frequent indications for EN. Elevenpatients (78.57%) reported complications associated to EN, mostlydigestive (57.14%). The main cause for consultation was relatedto the administration of drugs via NGT (nasogastric tube). Atotal of 77 drugs were prescribed, 23 of which were administeredin this way, so a guidelines for the administration of drugs vianasogastric tube was prepared.Conclusions: The hospital pharmacist can actively cooperatewith nutritional support units, given the need to assess the nutritionalsupport administered and to manage potential complicationsand interactions between nutritional status, drugs and artificialnutrition. The pharmacist also plays a significant role in theprevention and identification of problems related to the administrationof drugs via NGT

[Tacrolimus blood levels and incidence of graft rejection in heart transplantation]. / Relación entre los niveles de tacrolimus en sangre y la incidencia de rechazo en enfermos trasplantados de corazón.

OBJECTIVE: To determine the relationship between pharmacokinetic parameters and clinical outcomes after heart transplantation and to determine the range of tacrolimus blood levels which provides the most effective protection against graft rejection. To study other factors that predict graft rejection. METHOD: We retrospectively analyzed the clinical outcomes of all adult patients who received a heart transplant between January 2000 and October 2003 and had routine monitoring of tacrolimus trough levels at the time of scheduled endomyocardial biopsy. Rejection was defined as Grade = 3, based on the International Society for Heart and Lung Transplantation (ISHLT) criteria. The follow-up period was 1 year. All patients were on a triple therapy regimen of Tacrolimus (TAC), Corticosteroids and Azatioprine/Micophenolate Mofetil. Data were analyzed by Student s t-test, univariate logistic regression and ROC curve. RESULTS: Tacrolimus blood levels measured at day +5 postransplant were the strongest predictor of acute graft rejection over a 1-year follow-up period (rejection 5.76 +/- 3.4 ng/ml vs no rejection 9.66 +/- 2.73 ng/ml, p = 0.016). A decrease of one unit in TAC trough level values at day +5 postransplant implied a 1.58 greater risk of rejection (p = 0.05). Overall incidence of treated acute rejection was lower for patients with trough levels higher than 8 ng/ml on day +5 postransplant (33 vs 80%, p = 0.055, Fisher s exact test). CONCLUSIONS: Data suggest that in heart transplant patients it may be crucial to achieve tacrolimus levels of at least 8 ng/ml during the first days postsurgery to avoid rejection.

Relación entre los niveles de tacrolimus en sangre y la incidencia de rechazo en enfermos trasplantados de corazón / Tacrolimus blood levels and incidence of graft rejection in heart transplantation

Objetivo: Evaluar la relación entre los niveles en sangre de tacrolimus, la incidencia de rechazo agudo en enfermos trasplantados de corazón y determinar el rango de concentración más adecuado para prevenir el rechazo. Estudiar otros factores predictores del rechazo. Método: Se realizó un estudio retrospectivo de todos los enfermos adultos trasplantados de corazón entre enero de 2000 y octubre de 2003 en tratamiento con tacrolimus, corticoides y azatioprina/ micofenolato mofetil. La eficacia del tratamiento se evaluó por confirmación histopatológica del rechazo agudo como grado ≥ 3A según criterios del Sociedad Internacional de Trasplante de Pulmón y Corazón (ISHLT). Se registraron los resultados de las biopsias endomiocárdicas y de los niveles mínimos de tacrolimus en sangre durante el primer año postrasplante. El análisis de los datos se realizó mediante la t de Student, regresión logística univariante y curva ROC. Resultados: Se encontraron diferencias significativas en la concentración mínima de tacrolimus en sangre alcanzada el día +5 postrasplante entre los enfermos que presentaron algún episodio de rechazo agudo el primer año y los que no (5,76 ± 3,4 vs 9,66 ± 2,73 ng/ml, p = 0,016). El nivel el día +5 fue el mejor predictor del rechazo (p = 0,05) de modo que el riesgo de un paciente respecto a otro con una unidad menos en el nivel de tacrolimus es 1,58 veces mayor. 8 ng/ml es el nivel con mayor poder de discriminación (sensibilidad = 75% y especificidad = 72,7%), de modo que alcanzar una concentración mínima en sangre de 8 ng/ml el día +5 reduce la incidencia de rechazo agudo de 33 a 80% (p = 0,055, p. exacta de Fisher). Conclusiones: Alcanzar niveles mínimos adecuados de tacrolimus en los primeros días postrasplante (al menos de 8 ng/ml el día +5) puede ser crucial para evitar el rechazo agudo en pacientes trasplantados de corazón

Objective: To determine the relationship between pharmacokinetic parameters and clinical outcomes after heart transplantation and to determine the range of tacrolimus blood levels which provides the most effective protection against graft rejection. To study other factors that predict graft rejection. Method: We retrospectively analyzed the clinical outcomes of all adult patients who received a heart transplant between January 2000 and October 2003 and had routine monitoring of tacrolimus trough levels at the time of scheduled endomyocardial biopsy. Rejection was defined as Grade ≥ 3, based on the International Society for Heart and Lung Transplantation (ISHLT) criteria. The follow-up period was 1 year. All patients were on a triple therapy regimen of Tacrolimus (TAC), Corticosteroids and Azatioprine/Micophenolate Mofetil. Data were analyzed by Student’s t-test, univariate logistic regression and ROC curve. Results: Tacrolimus blood levels measured at day +5 postransplant were the strongest predictor of acute graft rejection over a 1- year follow-up period (rejection 5.76 ± 3.4 ng/ml vs no rejection 9.66 ± 2.73 ng/ml, p = 0.016). A decrease of one unit in TAC trough level values at day +5 postransplant implied a 1.58 greater risk of rejection (p = 0.05). Overall incidence of treated acute rejection was lower for patients with trough levels higher than 8 ng/ml on day +5 postransplant (33 vs 80%, p = 0.055, Fisher’s exact test). Conclusions: Data suggest that in heart transplant patients it may be crucial to achieve tacrolimus levels of at least 8 ng/ml during the first days postsurgery to avoid rejection