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[Assessment of a Tiapride solution for its administration through continuous intravenous perfusion]. / Estudio de estabilidad de tiaprida en disolución para administración en perfusión intravenosa continua.

OBJECTIVES: Tiapride is a substituted benzamide classified as an atypical neuroleptic. To our knowledge, there are no published data on its stability prepared as a continuous intravenous infusion. The current study analysed its stability in two different infusion solutions and concentrations over 48 hours. METHOD: Triplicate samples of tiapride were prepared in 0.9% sodium chloride and in 5% dextrose solutions at final concentrations of 1 and 2 mg/ml. Samples were collected in glass bottles without photoprotection and at room temperature (25 ± 2 °C). Sampling times at 0, 1, 3, 6, 12, 24 and 48 hours included a visual inspection for colour changes and appearance of precipitation as well as pH determination. Tiapride was quantified at selected times by mass spectrometry using high-performance liquid chromatography. Concentration values in the samples corresponding to 0 hours were given a reference value of 100%. Concentrations in subsequent samples greater than 90% were considered stable. RESULTS: No colour change or precipitation was observed during the study period. pH values ranged between 0.1 and 0.4 units. At 48 hours, the concentration of remaining tiapride in sodium chloride 1 mg/ml and 2 mg/ml was 93.8% and 91.6%, respectively. That in 5% dextrose 1 mg/ml and 2 mg/ml was 96.8% and 94.1%, respectively. CONCLUSION: Dilutions of tiapride in 0.9% sodium chloride and in 5% dextrose solution, at concentrations of 1 mg/ml and 2 mg/ml, in glass bottles and at room temperature were stable both physically and chemically during 48 hours.

Estudio de la estabilidad de tiaprida en disolución para administración en perfusión intravenosa continua / Assessment of a Tiapride solution for its administration through continuous intravenous perfusion

Objetivo: La tiaprida es una benzamida sustituida clasificada como neuroléptica atípica. Ante la ausencia de datos publicados sobre su estabilidad en disolución para administración en perfusión continua intravenosa, este estudio analiza la estabilidad de la tiaprida en diferentes soluciones para infusión intravenosa, a diferentes concentraciones y durante 48 horas. Método: Se prepararon muestras de tiaprida por triplicado en cloruro sódico al 0,9% y en glucosa al 5% a concentraciones de 1 y 2 mg/mL. Estas muestras se conservaron en recipientes de cristal sin fotoprotección, a temperatura ambiente (25 ± 2oC). Los tiempos de muestreo a las 0, 1, 3, 6, 12, 24 y 48 horas incluyeron inspección visual y determinación del pH. Se cuantificó la concentración de tiaprida en las muestras mediante cromatografía líquida de alta eficacia acoplada a espectrometría de masas. A los valores de concentración a tiempo 0 se les asignó el valor de referencia del 100%. Se consideraron estables aquellas muestras con concentración de tiaprida superior al 90% de la inicial. Resultados: No se observaron cambios visibles en las muestras analizadas. El valor del pH varió en un rango de entre 0,1 y 0,4 unidades. A las 48 horas, la concentración remanente en cloruro sódico a 1 y 2 mg/mL fue 93,8% y 91,6%, respectivamente. En glucosa al 5%, a 1 y 2 mg/mL fue 96,8% y 94,1%, respectivamente. Conclusión: Las disoluciones de tiaprida en cloruro sódico al 0,9% y en glucosa al 5%, a concentraciones de 1 y 2 mg/mL, en recipientes de cristal sin fotoprotección, a temperatura ambiente, son estables física y químicamente durante 48 horas (AU)

Objectives: Tiapride is a substituted benzamide classified as an atypical neuroleptic. To our knowledge, there are no published data on its stability prepared as a continuous intravenous infusion. The current study analysed its stability in two different infusion solutions and concentrations over 48 hours. Method: Triplicate samples of tiapride were prepared in 0.9% sodium chloride and in 5% dextrose solutions at final concentrations of 1 and 2 mg/ml. Samples were collected in glass bottles without photoprotection and at room temperature (25 ± 2oC). Sampling times at 0, 1, 3, 6, 12, 24 and 48 hours included a visual inspection for colour changes and appearance of precipitation as well as pH determination. Tiapride was quantified at selected times by mass spectrometry using high-performance liquid chro-matography. Concentration values in the samples corresponding to 0 hours were given a reference value of 100%. Concentrations in subsequent samples greater than 90% were considered stable. Results: No colour change or precipitation was observed during the study period. pH values ranged between 0.1 and 0.4 units. At 48 hours, the concentration of remaining tiapride in sodium chloride 1 mg/ml and 2 mg/ml was 93.8% and 91.6%, respectively. That in 5% dextrose 1 mg/ml and 2 mg/ml was 96.8% and 94.1%, respectively. Conclusion: Dilutions of tiapride in 0.9% sodium chloride and in 5% dextrose solution, at concentrations of 1 mg/ml and 2 mg/ml, in glass bottles and at room temperature were stable both physically and chemically during 48 hours (AU)

Experiencia de uso de partículas DC Bead ® cargadas con doxorrubicina en quimioembolización hepática / Experience Using Doxorubicin-Loaded DC Beads ® During Hepatic Chemoembolisation

Introducción El carcinoma hepatocelular es el más común y agresivo del grupo de tumores hepatobiliares. La quimioembolización hepática con partículas DC Bead® cargadas de doxorrubicina es un tipo de terapia local para pacientes con nódulos localizados, no susceptibles de cirugía. El objetivo de este estudio es describir las situaciones clínicas en las que se ha utilizado este procedimiento y su toxicidad temprana. Métodos Estudio descriptivo retrospectivo de los pacientes tratados con partículas DC Bead® cargadas de doxorrubicina en quimioembolización hepática desde octubre de 2006 hasta julio de 2009. Los datos se obtuvieron del programa Farhos Oncología® y las historias clínicas. Resultados Durante el periodo de estudio fueron tratados 21 pacientes, 15 hombres y 6 mujeres con una mediana de edad de 66 años. El diagnóstico que motivó la utilización de la técnica fue hepatocarcinoma no resecable. Del total de pacientes, 6 se encontraban en lista de espera para trasplante hepático. Los pacientes fueron clasificados según el sistema Child-Pugh: 15 pacientes en el grupo A, 5 en el grupo B y uno en el C, y según el Sistema Okuda: 14 pertenecían al grupo I, 6 al grupo II y uno al grupo III. La toxicidad más frecuente fue la aparición de síndrome posquimioembolización en 16 pacientes, que se resolvió con medicación sintomática. Discusión La utilización de doxorrubicina cargada en microesferas DC Bead® en quimioembolización transarterial se ha ajustado a usos con evidencias científicas y ha sido bien tolerado en todos los pacientes. Las incidencias durante la administración fueron leves y se resolvieron con medicación sintomática (AU)

Introduction Hepatocellular carcinoma is the most common and aggressive liver and biliary tumour. Hepatic chemoembolisation with doxorubicin-loaded DC Beads® is a local therapy for patients with localised nodes, which are not suitable for surgery. The objective of this study is to describe the clinical situations in which this procedure has been used and its early toxicity. Methods Retrospective descriptive study of patients treated with doxorubicin-loaded DC Beads® undergoing hepatic chemoembolisation from October 2006 until July 2009. Data were taken from the Farhos Oncología® programme and clinical histories. Results Twenty-two patients were treated during the study period, 15 men and 6 women, with an average age of 66 years. This technique was used for patients diagnosed with unresectable liver cancer. Out of the patient total, 6 were on the liver transplant waiting list. Patients were assessed using the Child–Pugh score: 15 patients in group A, 5 in group B and 1 in group C; and according to Okuda staging system: 14 were in group I, 6 in group II and 1 in group III. The most common toxicity was post-chemoembolisation in 16 patients, who were treated with symptomatic medication. Discussion Using doxorubicin-loaded microspherical DC Beads® during transarterial chemoembolisation has been adapted to use with scientific evidence and tolerated by all patients. Incidences during administration were mild and were resolved with symptomatic medication (AU)

[Experience using doxorubicin-loaded DC Beads® during hepatic chemoembolisation]. / Experiencia de uso de partículas DC Bead® cargadas con doxorrubicina en quimioembolización hepática.

INTRODUCTION: Hepatocellular carcinoma is the most common and aggressive liver and biliary tumour. Hepatic chemoembolisation with doxorubicin-loaded DC Beads(®) is a local therapy for patients with localised nodes, which are not suitable for surgery. The objective of this study is to describe the clinical situations in which this procedure has been used and its early toxicity. METHODS: Retrospective descriptive study of patients treated with doxorubicin-loaded DC Beads(®) undergoing hepatic chemoembolisation from October 2006 until July 2009. Data were taken from the Farhos Oncología(®) programme and clinical histories. RESULTS: Twenty-two patients were treated during the study period, 15 men and 6 women, with an average age of 66 years. This technique was used for patients diagnosed with unresectable liver cancer. Out of the patient total, 6 were on the liver transplant waiting list. Patients were assessed using the Child-Pugh score: 15 patients in group A, 5 in group B and 1 in group C; and according to Okuda staging system: 14 were in group I, 6 in group II and 1 in group III. The most common toxicity was post-chemoembolisation in 16 patients, which were treated with symptomatic medication. DISCUSSION: Using doxorubicin-loaded microspherical DC Beads(®) during transarterial chemoembolisation has been adapted to uses with scientific evidence and tolerated by all patients. Incidences during administration were mild and were resolved with symptomatic medication.

[Role of allopurinol and rofecoxib in agranulocytosis and acute tubular necrosis]. / Implicación de alopurinol y rofecoxib en agranulocitosis y necrosis tubular aguda.

OBJECTIVE: To report the case of a patient who developed a life-threatening agranulocytosis and acute tubular necrosis after the administration of allopurinol and rofecoxib. CASE REPORT: After minor surgery, a 70-year-old male underwent a routine blood test which encountered: anemia, leucopenia, neutropenia, thrombopenia, and altered creatinine levels. Both marrow and renal biopsies were performed, yielding the following results: acute tubular necrosis and agranulocytosis in the recovery stage. One month and a half before the aforementioned surgery a routine blood test had been performed, which showed normal values. The patient had then received allopurinol 100 mg/day for around 2 months, and rofecoxib 2.5 mg/day for 14 days. DISCUSSION: After ruling out other possible causes, a diagnosis of iatrogenically induced agranulocytosis and acute tubular necrosis was reached. We used a (modified) Karch-Lasagna algorithm with both drugs, and found the following imputability values: possible for rofecoxib and probable for allopurinol. In view of the widespread use of rofecoxib and COX-2 inhibitors, despite their recent availability, and of their potential role in the severe adverse effects discussed, healthcare professionals must be on the alert for the development of symptoms suggesting said or other adverse effects.

Implicación de alopurinol y rofecoxib en agranulocitosis y necrosis tubular aguda / Role of allopurinol and rofecoxib in agranulocytosis and acute tubular necrosis

Objetivo: Describir el caso de un paciente que desarrolló una agranulocitosis y una necrosis tubular aguda que comprometió su vida tras la administración de alopurinol y rofecoxib. Descripción del caso: Varón de 70 años, al que se le realizó una analítica de control tras una intervención menor, observándose anemia, leucopenia, neutropenia, trombopenia y alteración de los niveles de creatinina. Se efectuó biopsia renal y medular con el resultado de necrosis tubular aguda y médula compatible con agranulocitosis en fase de recuperación. Mes y medio antes de la intervención indicada se le había realizado una analítica de control encontrando valores dentro de la normalidad. Anteriormente el paciente había iniciado tratamiento con alopurinol 100 mg al día durante aproximadamente 2 meses, y rofecoxib 2,5 mg al día durante 14 días. Comentario: Tras descartar otras posibles causas, se llegó al diagnóstico de agranulocitosis y necrosis tubular aguda de origen iatrogénico. Aplicamos el algoritmo de Karsch-Lasagna (modificado) para ambos fármacos, encontrando los siguientes valores de imputabilidad: posible para el rofecoxib y probable para el alopurinol. Debido al amplio uso de rofecoxib y los inhibidores de la COX-2, a pesar de su reciente comercialización, y su posible implicación en los graves efectos adversos descritos, los profesionales sanitarios deben estar alertados ante la aparición de síntomas que puedan hacer sospechar la aparición de éstos u otros efectos adversos (AU)

[The assessment of the nutritional status of patients with familial amyloid neuropathy type I (Corino Andrade's disease) who are candidates for orthotopic liver transplantation]. / Valoración del estado nutricional de los pacientes con polineuropatía amiloidótica familiar tipo I (enfermedad de Corino Andrade) candidatos a trasplante ortotópico de hígado.

Corino Andrade's disease (Type I Family amyloidotic polyneuropathy) (FAP I) is a slow-evolving hereditary amyloidosis affecting, among other things, the digestive system, with the appearance of an amyloid deposit which produces a malabsorptive syndrome with diarrhea in those affected. At present, the only effective therapeutic option is orthotopic liver transplant (OLT): clearance from the hospital's transplant commission as a candidate requires, among other things, a prior nutritional study. We therefore proposed to carry out a nutritional assessment of these patients, comparing them with a group of terminal liver patients who are OLT candidates. The PAF I group showed a high level of calorie energy malnutrition (86%) and, to a lesser extent, visceral and protein malnutrition. The liver patient group showed 67% of visceral malnutrition and lower levels of calorific energy and protein malnutrition. All the OLT candidates showed a high rate of nutritional deterioration. The greater presence of calorific energy malnutrition in the PAF I patients might be due to the neuropathic gastro-intestinal condition. The high level of malnutrition encountered suggest the need for pre-transplant nutritional intervention designed to minimise post-surgical risk.

[The assessment of the nutritional status of patients in the terminal stage of liver disease who are candidates for orthotopic liver transplantation]. / Valoración del estado nutricional de los pacientes en estadio terminal de enfermedad hepática, candidatos a trasplante ortotópico de hígado.

Orthotopic liver transplant (OLT) is nowadays an accepted procedure for the treatment of patients with end-stage liver disease. Because of the significant state of malnutrition of such patients, we decided to evaluate the nutritional condition of patients accepted by the hospital's Transplants Committee as candidates for this type of therapy, with the eventual aim of discovering the types of malnutrition in the different pathologies, and which were the most frequent. The sample studied showed a significant prevalence of malnutrition. Patients with viral hepatitis showed only visceral type malnutrition, which affected 100% of them. The ethanolic cirrhosis group presented all types of malnutrition-energy-calorific (35%), protein (24%) and visceral (53%), while the group of other liver diseases presented 15% of energy-calorific malnutrition and 85% visceral. From these results, we conclude that the sample studied has a high prevalence of malnutrition and that the importance of its detection makes it possible to reduce pre- and post-surgical morbidity and mortality rates with an appropriate nutritional support.