Análisis y mejora de la preparación y manipulación de medicamentos peligrosos orales en un Servicio de Farmacia Hospitalaria / Analysis and improvement of preparation and handling of hazardous oral drugs in a Hospital Pharmacy Department

OBJETIVOS: Identificar de forma detallada las actividades en las cuales la exposición al riesgo es mayor por fallo en el manejo del medicamento peligroso (MP) o las medidas de autoprotección, y valorar su reducción tras llevar a la práctica una sesión formativa. MÉTODOS: Estudio observacional y prospectivo, realizado en un hospital general de especialidades. Durante dos meses se lleva a cabo mediante el método de observación directa, un análisis de la manipulación y reenvasado de medicamentos peligrosos orales por personal técnico. Este periodo se dividió en dos etapas, tomando como punto de inflexión una sesión formativa al personal de farmacia al que se le explicaron los nuevos circuitos de trabajo para el manejo seguro de los medicamentos peligrosos, los protocolos elaborados, se informó sobre el manejo de los equipos de protección individual, y se entregó la documentación comentada. Posteriormente, las manipulaciones inseguras se categorizaron según la documentación de referencia: NIOSH y INSHT. RESULTADOS: El número total de observaciones fue 181; 68 durante el primer periodo, de las cuales 11 (16,2%) correspondieron al reenvasado de MP orales. En todos los casos hubo una manipulación insegura.113 observaciones en el segundo periodo, de ellas 16 (14,1%) fueron de reenvasado de MP. La probabilidad de error fue del 81,3%. En todos los casos la mayor probabilidad de error se asoció al empleo de los equipos de protección individual. CONCLUSIONES: Mediante el método de la observación directa se han identificado los subprocesos donde es necesario incidir para disminuir el riesgo asociado al manejo de estos fármacos, que se han reducido parcialmente tras el empleo de una sesión formativa

OBJECTIVE: Detect in detail the activities which the exposure is greater due to failure in the use of the hazardous drugs or self-protection measures and assess their reduction after carrying out a training session. METHODS: Prospective and observational study in a general hospital of specialties. For two months to take place by direct observation, an analysis of handling and repackaging of hazardous oral drugs by a technical staff. This time was divided in two stages, taking a training session to pharmacy staff as a turning point, which explained the new system work, protocols developed, it was reported on the management of individual protection equipment and documentation was delivered. Later, the unsafe handling were categorised according the reference documentation: NIOSH and INSHT. RESULTS: The total number of observation was 181; 68 for the first time, which 11 (16,2%) accounted for the repackaging of hazardous oral drugs. In all cases there was a unsafe handling.113 observations in the second period, which 16 (14,1%) were repackaging of hazardous oral drugs. The probability of error was 81,3%. In all cases, the highest probability of error was associated with the use of personal protective equipment. CONCLUSIONS: Using the direct observation method, the sub-processes have been identified where it is necessary to reduce the risk associated with the management of these drugs, which have been partially reduced after the use of a formative session

Conciliación de la medicación en las transiciones asistenciales de pacientes previamente ingresados / Medication reconciliation in inpatient transfers

OBJETIVOS: Valorar la efectividad de la intervención farmacéutica y caracterizar los tipos de discrepancias y errores de conciliación de la medicación, en el contexto de un programa de conciliación de la medicación durante el ingreso hospitalario de pacientes sometidos a una transición asistencial interna, cuya procedencia ha sido otro centro hospitalario o la unidad de cuidados intensivos. MÉTODOS: Estudio prospectivo realizado en un hospital de especialidades. La población objeto de estudio han sido los pacientes que generaron estancia en nuestro centro durante un periodo de 8 meses, y cuya procedencia fue otro centro hospitalario o la unidad de cuidados intensivos (UCI). Diariamente se revisaron todos aquellos pacientes procedentes de una transición asistencial y posteriormente, se elaboró la mejor historia farmacoterapéutica posible revisando la información disponible sobre la medicación que podía estar recibiendo el paciente de forma previa a la transición asistencial y completando el proceso mediante una entrevista clínica. Las discrepancias que requerían aclaración fueron comunicadas al médico. RESULTADOS: Se conciliaron un total de 350 medicamentos en 136 pacientes (una media de 2,6 fármacos por paciente). Se realizaron 139 actos de conciliación, de los cuales, en 68 se encontraron discrepancias justificadas, en 53 no se encontraron discrepancias y en los 18 restantes se encontraron discrepancias que requerían aclaración, siendo la más habitual entre ellas la omisión de un medicamento seguida de la prescripción incompleta y modificación de posología o vía sin justificación. De esas discrepancias, 15 fueron aceptadas por parte del médico prescriptor, modificando posteriormente la prescripción. La mayoría de los fármacos con esas discrepancias pertenecían a los grupos anatomoterapéuticos: tracto alimentario y metabolismo, sistema cardiovascular, sistema nervioso y sistema respiratorio. CONCLUSIONES: La conciliación de la medicación durante las transiciones asistenciales llevada a cabo por un farmacéutico mostró ser útil en la identificación y prevención de errores de medicación con potenciales consecuencias clínicas para los pacientes

OBJECTIVE: To assess the effectiveness of the pharmaceutical intervention and characterize the types of discrepancies and errors of medication reconciliation, in the context of a program of medication reconciliation during inpatient transfers, whose origin has been other hospital or the intensive care unit. METHODS: An eight months prospective, observational study was carried out in a secondary hospital. Patients were selected when they were transferred to a medical unit of our hospital from an intensive care unit (ICU), a coronary intensive care unit (CICU) or other hospitals. Daily, in order to conduct the reconciliation process, the Pharmacist prepared the best pharmacotherapeutical history possible, reviewing all available information about the medication the patient could be taking before, and completing the process with a clinical interview. The discrepancies requiring clarification were reported to the physician. RESULTS: 350 medications were reconciled in 136 patients, with a mean of 2,6 drugs per patient.139 reconciliations were made: 68 were considered as justified discrepancies, 53 as no discrepancies and the remaining 18 as discrepancies that required clarification; the most frequent was the omission of a medication, followed by incomplete prescription and unjustified modification of dosing or way of administration. Among these 18 discrepancies, 15 were accepted by the hospital physician and prescriptions were modified. Most of the drugs with these discrepancies belonged to the anatomical-therapeutic groups: alimentary tract and metabolism, cardiovascular system, nervous system and respiratory system. CONCLUSIONS: The medication reconciliation process conducted by a pharmacist has proven to be useful in the identification and prevention of medication errors with potential clinical consequences for patients

[Review of pharmacological interactions of oral anticancer drugs provided at pharmacy department]. / Revisión de las interacciones farmacológicas de los fármacos antineoplásicos orales dispensados en un Servicio de Farmacia.

OBJECTIVE: To identify the pharmacologic interactions of oral anti-cancer drugs provided at an outpatient clinic. MATERIAL AND METHODS: Anti-cancer drugs included in the Phamacotherapeutic Guideline of the Hospital were identified. A literature search was carried out on the pharmacologic interactions in MEDLINE® and EMBASE® (with the filer language English or Spanish, and the descriptors: "name of the anti-cancer drug" AND ("drug interactions" OR "pharmacokinetic")), Up-to-date®, MICROMEDEX® and the drug information sheet for the EMA and the FDA. Information was also gathered from the abstract presented to European and Spanish scientific meetings for the last 4 years. When an interaction was analyzed and had clinical relevance, the best pharmacotherapeutic interaction-free alternative was sought. RESULTS: Twenty-three drugs were identified, of which Chlorambucil, Fludarabine, Lenalidomide, Melphalan, and Thalidomide were the active compounds with the lowest likelihood of producing a pharmacologic interaction. Tyrosine kinase inhibitors (particularly Erlotinib, Imatinib, Lapatinib, and Pazopanib) are the drugs with highest number of pharmacologic interactions described, many of them with severe clinical consequences, with increases and decreases of the plasma levels of anti-cancer drugs. The active compounds identified that may have pharmacologic interactions with anticancer drugs were mainly: Allopurinol, Amiodarone, Carbamazepine, Dabigatran, Digoxin, Spironolactone, Phenytoin, Itraconazol, Repaglinide, Silodosin, Tamoxifen, Verapamil, and Warfarin. Pharmacologic interactions through the cytochrome P450 1A2, 2D6, 2C8, 2C9, 3A4 were the most important for tyrosine kinase inhibitors. Other non-pharmacologic compounds, with an important potential of producing relevant pharmacologic interaction were immunomodulators (Echinacea extracts) and Hypericum perforatum. CONCLUSIONS: Oral anticancer drugs have numerous pharmacologic interactions that should be monitored during pharmacotherapy. Given its position, the hospital pharmacist is the key professional for identifying and assessing the pharmacologic interactions or oral anticancer drugs that may have clinical consequences.

OBJETIVO: Identificar las interacciones farmacológicas de los fármacos antineoplásicos orales dispensados desde una consulta de pacientes externos. MATERIAL Y MÉTODOS: Se identificaron los fármacos antineoplásicos incluidos en la Guía farmacoterapéutica del Complejo Hospitalario. Se realizó una búsqueda bibliográfica sobre sus interacciones farmacológicas en MEDLINE® y EMBASE® (tomando como límites los idiomas español e inglés, los descriptores: «nombre del fármaco antineoplásico¼ AND («drug interactions¼ OR «pharmacokinetic ¼)), Up-to-date®, MICROMEDEX® y ficha técnica del medicamento de la EMA y FDA. También se buscó información en los resúmenes de los congresos europeos y nacionales de los últimos 4 años. Cuando una interacción analizada resultó ser de relevancia clínica, se buscó la mejor alternativa farmacoterapéutica no interaccionante. RESULTADOS: Se identificaron veintitrés fármacos, de ellos, clorambucilo, fludarabina, lenalidomida, melfalan y talidomida son principios activos con menor probabilidad de ocasionar una interacción farmacológica. Los inhibidores de la tirosin kinasa (especialmente ertininib, imatinib, lapatinib y pazopanib) son los fármacos con más interacciones farmacológicas descritas, muchas de ellas con consecuencias clínicas severas, con aumentos y descensos de los niveles plasmáticos de los agentes antineoplásicos. Los principios activos identificados que pueden tener interacciones farmacológicas con antineoplásicos fueron principalmente: alopurinol, amiodarona, carbamazepina, dabigatran, digoxina, espironolactona, fenitoina, itraconazol, repaglinida, silodosina, tamoxifeno, verapamilo y warfarina. Las interacciones farmacológicas a través del citocromo P450 1A2, 2D6, 2C8, 2C9, 3A4 fueron las más importantes para los inhibidores de la tirosin kinasa. Otras sustancias no medicamentosas, con importante potencial de poder causar una interacción farmacológica de relevancia fueron los inmunomoduladores (extractos de equinacea) y el Hypericum perforatum. CONCLUSIONES: Los fármacos antineoplásicos orales poseen numerosas interacciones farmacológicas de interés que deben ser monitorizadas en farmacéutico de hospital, por el privilegiado papel que ocupa, es el profesional clave para identificar y valorar las interacciones farmacológicas de antineoplásicos orales que pudieran tener consecuencias clínicas.

Revisión de las interacciones farmacológicas de los fármacos antineoplásicos orales dispensados en un servicio de farmacia / Review of pharmacological interactions of oral anticancer drugs provided at pharmacy department

Objetivo: Identificar las interacciones farmacológicas de los fármacos antineoplásicos orales dispensados desde una consulta de pacientes externos. Material y métodos: Se identificaron los fármacos antineoplásicos incluidos en la Guía farmacoterapéutica del Complejo Hospitalario. Se realizó una búsqueda bibliográfica sobre sus interacciones farmacológicas en MEDLINE® y EMBASE® (tomando como límites los idiomas español e inglés, los descriptores: "nombre del fármaco antineoplásico" AND ("drug interactions" OR "pharmacokinetic")), Up-to-date®, MICROMEDEX® y ficha técnica del medicamento de la EMA y FDA. También se buscó información en los resúmenes de los congresos europeos y nacionales de los últimos 4 años. Cuando una interacción analizada resultó ser de relevancia clínica, se buscó la mejor alternativa farmacoterapéutica no interaccionante. Resultados: Se identificaron veintitrés fármacos, de ellos, clorambucilo, fludarabina, lenalidomida, melfalan y talidomida son principios activos con menor probabilidad de ocasionar una interacción farmacológica. Los inhibidores de la tirosin kinasa (especialmente ertininib, imatinib, lapatinib y pazopanib) son los fármacos con más interacciones farmacológicas descritas, muchas de ellas con consecuencias clínicas severas, con aumentos y descensos de los niveles plasmáticos de los agentes antineoplásicos. Los principios activos identificados que pueden tener interacciones farmacológicas con antineoplásicos fueron principalmente: alopurinol, amiodarona, carbamazepina, dabigatran, digoxina, espironolactona, fenitoina, itraconazol, repaglinida, silodosina, tamoxifeno, verapamilo y warfarina. Las interacciones farmacológicas a través del citocromo P450 1A2, 2D6, 2C8, 2C9, 3A4 fueron las más importantes para los inhibidores de la tirosin kinasa. Otras sustancias no medicamentosas, con importante potencial de poder causar una interacción farmacológica de relevancia fueron los inmunomoduladores (extractos de equinacea) y el Hypericum perforatum. Conclusiones: Los fármacos antineoplásicos orales poseen numerosas interacciones farmacológicas de interés que deben ser monitorizadas en farmacéutico de hospital, por el privilegiado papel que ocupa, es el profesional clave para identificar y valorar las interacciones farmacológicas de antineoplásicos orales que pudieran tener consecuencias clínicas

Objective: To identify the pharmacologic interactions of oral anti-cancer drugs provided at an outpatient clinic. Material and methods: Anti-cancer drugs included in the Phamacotherapeutic Guideline of the Hospital were identified. A literature search was carried out on the pharmacologic interactions in MEDLINE® and EMBASE® (with the filer language English or Spanish, and the descriptors: "name of the anti-cancer drug" AND ("drug interactions" OR "pharmacokinetic")), Up-to-date®, MICROMEDEX® and the drug information sheet for the EMA and the FDA. Information was also gathered from the abstract presented to European and Spanish scientific meetings for the last 4 years. When an interaction was analyzed and had clinical relevance, the best pharmacotherapeutic interaction-free alternative was sought. Results: Twenty-three drugs were identified, of which Chlorambucil, Fludarabine, Lenalidomide, Melphalan, and Thalidomide were the active compounds with the lowest likelihood of producing a pharmacologic interaction. Tyrosine kinase inhibitors (particularly Erlotinib, Imatinib, Lapatinib, and Pazopanib) are the drugs with highest number of pharmacologic interactions described, many of them with severe clinical consequences, with increases and decreases of the plasma levels of anti-cancer drugs. The active compounds identified that may have pharmacologic interactions with anticancer drugs were mainly: Allopurinol, Amiodarone, Carbamazepine, Dabigatran, Digoxin, Spironolactone, Phenytoin, Itraconazol, Repaglinide, Silodosin, Tamoxifen, Verapamil, and Warfarin. Pharmacologic interactions through the cytochrome P450 1A2, 2D6, 2C8, 2C9, 3A4 were the most important for tyrosine kinase inhibitors. Other non-pharmacologic compounds, with an important potential of producing relevant pharmacologic interaction were immunomodulators (Echinacea extracts) and Hypericum perforatum. Conclusions: Oral anticancer drugs have numerous pharmacologic interactions that should be monitored during pharmacotherapy. Given its position, the hospital pharmacist is the key professional for identifying and assessing the pharmacologic interactions or oral anticancer drugs that may have clinical consequences

Simplificación del tratamiento antirretroviral: una buena alternativa para nuestros pacientes y para la sostenibilidad de nuestro sistema sanitario / Simplification of Antiretroviral Therapy: A Good Choice for Our Patients and the Sustainability of Our Health Care System

Objetivo Describir la efectividad, seguridad, adherencia y ahorro económico de la monoterapia basada en lopinavir/ritonavir. Método Estudio observacional, descriptivo y retrospectivo que evaluó la monoterapia. La adherencia se calculó utilizando un método objetivo. Se estimaron los costes directos derivados de la no dispensación de la triple terapia. Resultados Identificamos 17 pacientes. La adherencia por intervalos fue: >95%, 9 pacientes; 90-95%, 2 pacientes; 90-85%, 2 pacientes; inferior al 85%, 4 pacientes. La carga viral fue indetectable durante las semanas 12, 24, 36 y 48 excepto en 2 pacientes. Las cifras de CD4 se mantuvieron en la mayor parte de las analíticas >350 cél./μl, y solo un paciente tuvo una cifra inferior. El ahorro medio fue 4.819 euros/paciente/año (rango 1.116 - 8.700).Conclusiones En pacientes seleccionados la monoterapia puede ser una opción terapéutica coste-efectiva(AU)

Objective To describe the efficacy, safety, compliance and cost savings of lopinavir/ritonavir monotherapy. Method Observational, descriptive and retrospective study evaluating monotherapy. Adherence was calculated using an objective method. We estimated the direct costs of dispensing non-triple therapy. Results We identified 17 patients. Interval adherence was >95% in 9 patients, 90%–95% in 2 patients, 90%–85% in 2 patients, and less than 85% in 4 patients. Viral load was undetectable during weeks 12, 24, 36, and 48, except in 2 patients. The CD4 count in most analytical tests remained at >350cells/ml, only 1 patient had a lower figure. The average savings was 4819 Euros/patient/year (range 1116–8700).Conclusions In selected patients, monotherapy can be a cost-effective treatment option (AU)

Simplification of antiretroviral therapy: a good choice for our patients and the sustainability of our health care system.

OBJECTIVE: To describe the efficacy, safety, compliance and cost savings of lopinavir/ritonavir monotherapy. METHOD: Observational, descriptive and retrospective study evaluating monotherapy. Adherence was calculated using an objective method. We estimated the direct costs of dispensing non-triple therapy. RESULTS: We identified 17 patients. Interval adherence was > 95% in 9 patients, 90-95% in 2 patients, 90-85% in 2 patients, and less than 85% in 4 patients. Viral load was undetectable during weeks 12, 24, 36 and 48, except in 2 patients. The CD4 count in most analytical tests remained at > 350 cells/ml, only 1 patient had a lower figure. The average savings was 4819 Euros/patient/year (range 1116 to 8700). CONCLUSIONS: In selected patients, monotherapy can be a cost-effective treatment option.

Elaboración de un plan de seguridad en una unidad de gestión clínica del medicamento / Preparation of a safety plan in a Clinical Medication Management Unit

Introducción. La seguridad del paciente se considera una prioridad en la asistencia sanitaria, actividad cada vez más compleja, que entraña riesgos potenciales y en la que no existe un sistema capaz de garantizar la ausencia de eventos adversos. El objetivo de este trabajo fue la elaboración de un Plan de Seguridad para una Unidad de Gestión Clínica del Medicamento. Método. Durante el periodo de 2 meses se realizó un mapa de riesgo de la Unidad de Gestión Clínica del Medicamento. Para ello se distribuyó una hoja de recogida de datos donde los miembros del servicio reflexionaban sobre los motivos de inseguridad de su ámbito de actuación. La priorización de los ítems seleccionados según la matriz de riesgo fue analizada mediante el método de Hanlon adaptado. Resultados. Se identificaron 55 riesgos específicos en 8 secciones de la farmacia: 11 en la unidad de quimioterapia, 11 en la dosis unitaria, 9 en los botiquines de enfermería, 8 en farmacotecnia, 5 en dispensación tradicional, 4 en la unidad de mezclas intravenosas, 4 en la unidad de atención farmacéutica, 3 en el almacén de farmacia. Tras la priorización se realizó el Plan de Seguridad de la Unidad de Gestión Clínica del Medicamento para el año 2009. Contempló 11 ítems: 7 en farmacotecnia, una en la dosis unitaria, una en el botiquín de enfermería, una en la dispensación tradicional y una en gestión de personal. Conclusiones. La elaboración de un Plan de Seguridad ha permitido identificar y priorizar nuestras actuaciones en materia de seguridad y profundizar en la concienciación del personal sanitario en general sobre la importancia de la seguridad del paciente(AU)

Introduction. Patient safety is seen as a priority in health care, and is becoming an increasingly complex activity, which involves potential risks. There is still no system that guarantees the absence of adverse events. The aim of this study was to prepare a Safety Plan for a Clinical Drugs Management Unit. Method. A risk assessment was made of the Clinical Drugs Management Unit over a 2 month period. To do this, a case form was distributed in which members of the Department reflected on the lack of safety in their working environment. The prioritising of the items selected from a risk matrix was analysed using the adapted Hanlon method. Results. A total of 55 specific risks were identified in 8 sections of pharmacy: 11 chemotherapy unit, 11 single dose, 9 nursing sick bay kits, 8 pharmacotechnical, 5 traditional dispensing, 4 intravenous mixtures unit, 4 pharmacy care unit, and 3 pharmacy stores. After prioritisation, the Clinical Drugs Management Unit Safety Plan was prepared. It looked at 11 items: Pharmacotechnical area 7, single dose 1, nursing sick bay kits 1, traditional dispensing 1 and personnel management 1. Conclusions. Preparing a Safety Plan has enabled us to identify and prioritise our safety activities and in general to make health staff more aware of the importance of patient safety(AU)

[Preparation of a safety plan in a Clinical Medication Management Unit]. / Elaboración de un plan de seguridad en una unidad de gestión clínica del medicamento.

INTRODUCTION: Patient safety is seen as a priority in health care, and is becoming an increasingly complex activity, which involves potential risks. There is still no system that guarantees the absence of adverse events. The aim of this study was to prepare a Safety Plan for a Clinical Drugs Management Unit. METHOD: A risk assessment was made of the Clinical Drugs Management Unit over a 2 month period. To do this, a case form was distributed in which members of the Department reflected on the lack of safety in their working environment. The prioritising of the items selected from a risk matrix was analysed using the adapted Hanlon method. RESULTS: A total of 55 specific risks were identified in 8 sections of pharmacy: 11 chemotherapy unit, 11 single dose, 9 nursing sick bay kits, 8 pharmacotechnical, 5 traditional dispensing, 4 intravenous mixtures unit, 4 pharmacy care unit, and 3 pharmacy stores. After prioritisation, the Clinical Drugs Management Unit Safety Plan was prepared. It looked at 11 items: Pharmacotechnical area 7, single dose 1, nursing sick bay kits 1, traditional dispensing 1 and personnel management 1. CONCLUSIONS: Preparing a Safety Plan has enabled us to identify and prioritise our safety activities and in general to make health staff more aware of the importance of patient safety.

[Effectiveness and safety of imatinib in seven gastrointestinal stromal tumor cases]. / Efectividad y seguridad de imatinib en siete casos de tumores del estroma gastrointestinal.

OBJECTIVE: To measure the effectiveness and safety of imatinib for gstrointestinal stromal tumors (GISTs). METHOD: A retrospective study from 1993 through June 2005 by identifying all patients diagnosed with GIST by the Pathology Department. The medical records of those treated with imatinib were reviewed. Demographic, diagnostic, therapeutic, and outcome-related data were collected. RESULTS: Twenty-five patients were identified, 7 of them treated with imatinib. Total responses were 4/7; 2/7 cases were complete responses, and 2/7 were partial responses. Mean actuarial disease-free survival was 10 months, and overall survival was 44 months. Adverse reactions (ARs) reported included: 33% (5) gastrointestinal events, 40% (6) dermatologic events and/or edema, 14% (2) blood toxicity, and 13% (2) asthenia. In all, 2/7 patients experienced no imatinib-related toxicity. CONCLUSIONS: In our experience, imatinib is an effective, well tolerated therapy for malignant [c-Kit (CD117)-positive], non-resectable and/or metastatic GIST.

Efectividad y seguridad de imatinib en siete casos de tumores del estroma gastrointestinal / Effectiveness and safety of imatinib in seven gastrointestinal stromal tumor cases

Objetivo: Medir la efectividad y seguridad de imatinib en lostumores del estroma gastrointestinal (GIST).Método: Estudio retrospectivo desde el año 1993 hasta juniode 2005 donde se identificaron todos los pacientes diagnosticadosde GIST por anatomía patológica, y se revisaron historias clínicasde los tratados con imatinib. Se recogieron datos demográficos,relativos al diagnóstico, al tratamiento y a la evolución.Resultados: Se identificaron 25 pacientes, 7 tratados conimatinib. La respuesta total fue de 4/7, 2/7 casos fueron respuestascompletas y otros 2/7 respuestas parciales. La mediana actuarialde supervivencia libre de enfermedad alcanzada fue de 10meses y la global 44 meses. Las reacciones adversas (RAM) recogidasfueron: 33% (5) gastrointestinales, 40% (6) dermatológicasy/o edema, 14% (2) toxicidad hematológica y 13% (2) astenia. El2/7 pacientes no experimentaron ningún tipo de toxicidad relacionadacon imatinib.Conclusiones: En nuestra experiencia, imatinib constituye untratamiento efectivo y de buena tolerancia para el GIST maligno[c-Kit (CD117) positivo] no resecable y/o metastásico

Objective: To measure the effectiveness and safety of imatinibfor gstrointestinal stromal tumors (GISTs).Method: A retrospective study from 1993 through June 2005by identifying all patients diagnosed with GIST by the PathologyDepartment. The medical records of those treated with imatinibwere reviewed. Demographic, diagnostic, therapeutic, and outcome-related data were collected.Results: Twenty-five patients were identified, 7 of them treatedwith imatinib. Total responses were 4/7; 2/7 cases were completeresponses, and 2/7 were partial responses. Mean actuarialdisease-free survival was 10 months, and overall survival was 44months. Adverse reactions (ARs) reported included: 33% (5) gastrointestinalevents, 40% (6) dermatologic events and/or edema,14% (2) blood toxicity, and 13% (2) asthenia. In all, 2/7 patientsexperienced no imatinib-related toxicity.Conclusions: In our experience, imatinib is an effective, welltolerated therapy for malignant [c-Kit (CD117)-positive], nonresectableand/or metastatic GIST

[Predictive model for prostate cancer in patients with biopsy indication]. / Modelo predictivo de cáncer de próstata en pacientes con indicación de biopsia.

OBJECTIVE: Attemp to determine the probability of developing prostate carcinoma taking into acc age, digital rectal examination and PSA once a transrectal biopsy has been indicated, so that both doctors and patients have mor information to face such pathology. MATERIAL AND METHODS: Retrospective study of 633 biopsies, taken into acc the patient's age, digital rectal examination, PSA level and histology. The data were included in a database created with Access and were put a logistic regression by mens the software program SPSS. RESULTS: Once the biopsy is indicated, digital rectal examination is the parameter offesing a higher discriminatory valuer with an odd ratio of 5.9 (CI 95%, 3.9-8.9). The mathematical model obtained shows a sensitivity level of 57% and a level of specificity of 84%. Pre-test probability is 36%, the probability post-test increasing up to 70%, and a negative predictive value of 77% and a positive predictive value of 67%. CONCLUSIONS: The mathematical model obtained individually determines the probability of suffering from prostatic carcinoma. Moreover, using this model the probabilities obtained re more precise than those derived from the fact of fulfilling the criteria for a prostatic biopsy. Once a biopsy is indicated, the rectal examination becomes the parameter with a higher predictive value of PC, irrespective of PSA and age. The PPV of the model is higher than of the PSA or the digital recta examination used separately.

Modelo predictivo de cáncer de próstata en pacientes con indicación de biopsia / Predictive model for prostate cancer in patients with biopsy indication

OBJETIVO: Intentar conocer la probabilidad de padecer un carcinoma de próstata (CP) en base a la edad, tacto rectal (TR) y PSA, una vez indicada la realización de biopsia, con el fin de poseer mayor información a la hora de enfrentarnos, médico y paciente, a dicho problema. MATERIAL Y MÉTODO: Estudio retrospectivo de 633 biopsias prostáticas, analizando edad, TR, nivel de PSA y resultado histológico. Los datos fueron incluidos en una base de datos de Access, analizándolos mediante el programa SPSS con el que se realizó un análisis de regresión logística. RESULTADOS: Una vez indicada la biopsia, el TR es la variable con mayor poder de discriminación, con una odd ratio ajustada de 5,9 (IC 95 por ciento, 3,9-8,9). El modelo matemático obtenido posee una sensibilidad del 57 por ciento y una especificidad del 84 por ciento. La probabilidad pretest fue del 36 por ciento, pasando al 70 por ciento postest, con un valor predictivo negativo del 77 por ciento y positivo del 67 por ciento. CONCLUSIONES: El modelo matemático obtenido determina de forma individualizada la probabilidad de padecer un CP, y a su vez, más ajustada que la derivada de cumplir los criterios de biopsia. Una vez indicada la biopsia, la variable con mayor peso en la probabilidad de padecer CP es el TR, con independencia del PSA y la edad. El valor predictivo positivo del modelo es superior al del PSA o del TR utilizados de forma aislada (AU)

[Renal cancer: descriptive analysis of a series of 267 intervened cases]. / Cáncer renal: análisis descriptivo de una serie de 267 casos intervenidos.

OBJECTIVE: To present the results of a descriptive analysis of 267 surgically treated renal tumors. METHODS: From January 1986 to October 1999, 267 patients (153 males and 114 females) with renal tumor were treated in our department. All data were introduced into the Access data base program and analyzed using the SPSS software. Descriptive analysis was performed and life expectancy was calculated with the Kaplan-Meier survival curve. Mean follow-up was 42.72 months. RESULTS: 56.4% were in the right and 43.6% were in the left kidney. 41.2% of the cases were incidentally discovered. In the symptomatic patients, the most common presenting feature was hematuria (51.8%). Radical nephrectomy was performed in 94.2%, partial in 3.1% and tumor resection in 2.7%. The lumbar approach was used in 75.5% of the cases. In regard to the histology, 88.7% were carcinomas. Clear cell was the most frequent cell type (91.5%). By grade, 55.8% were GI, 32.9% GII and 11.3% were GIII. By stage (according to the 1992 TNM classification), 64.3% were stage I, 15.4% stage II, 17% stage III and 3.3% stage IV. 80.5% showed no vascular involvement. The 5-year overall survival was 71.93% (mean 114 months; median 167 months). Currently, 76% of the patients are alive. CONCLUSIONS: Distribution by sex in our series was different to that reported in most of the studies. The tumor was incidentally discovered in a high proportion of the cases. The lumbar access was the most widely used surgical approach. The overall survival is similar to that reported by other groups.

[Incidental diagnosis of renal carcinoma. Does it imply a better prognosis?]. / Diagnóstico incidental del carcinoma renal. Implica un mejor pronóstico?

OBJECTIVE: We present 267 patients undergoing surgery for renal carcinoma, comparing the incidental tumour and symptomatic tumour with different parameters and evaluating the prognostic significance of the incidental diagnosis. MATERIAL AND METHODS: Of the 267 patients, 110 (41.2%) were diagnosed incidentally. The different variables analysed were: age, sex, tumour size, if unilateral or bilateral, histological type, stage, degree of cellular differentiation and survival. The mean follow-up period was of 43.32 mos in the symptomatic patients and 41.85 mos in the patients diagnosed incidentally. The data obtained was analysed with the SPSS statistic pack. RESULTS: No significant difference was detected between both groups in regards to age, sex, if unilateral or bilateral and histological type. Comparing tumour size, a statistic difference was observed with slices at 6 cm. When analysing the stage and degree of cellular differentiation, a significant difference is found with tumours diagnosed incidentally presenting better differentiation and a lower stage at the moment of diagnosis. Survival after 5 yrs was of 65.7% for symptomatic patients in comparison to 81.7% for the incidental group, which implies high statistical signification (log rank = 0.0018). CONCLUSIONS: In our series no significant differences were detected between incidental and symptomatic tumours when comparing age, sex, anatomic side and histological type. Significant differences were indeed detected in relation to size, degree of cellular differentiation, tumour stage and survival.

[Kluyvera ascorbata. Case report of a patient with Crohn's disease]. / Kluyvera ascorbata. Presentación de un caso en paciente con enfermedad de Crohn.

For the not frequent, we contributed a new case of infection urinary produced by the I generate Kluyvera. We make a bibliographical review, clinical expression of the same and we insisted in a series of peculiarities, you like the appearance give because of the treatment pharmacologic and their intestinals.