Definition and validation of SNOMED CT subsets using the expression constraint language.

BACKGROUND: SNOMED CT Expression Constraint Language (ECL) is a declarative language developed by SNOMED International for the definition of SNOMED CT Expression Constraints (ECs). ECs are executable expressions that define intensional subsets of clinical meanings by stating constraints over the logic definition of concepts. The execution of an EC on some SNOMED CT substrate yields the intended subset, and it requires an execution engine able to receive an EC as input, execute it, and return the matching concepts. An important issue regarding subsets of clinical concepts is their use in terminology binding between clinical information models and terminologies for defining the set of valid values of codified data. OBJECTIVE: To define and implement methods for the simplification, semantic validation and execution of ECs over a graph-oriented SNOMED CT database, and to provide a method for the visual representation of subsets in order to explore, understand and validate its content, as well as to develop an EC execution platform, called SNQuery, which makes use of these methods. METHODS: Since SNOMED CT is a directed and acyclic graph, we have used a graph-oriented database to represent the content of SNOMED CT, where the schema and instances are represented as graphs and the data manipulation is expressed by graph-oriented operations. For the execution of ECs over the graph database, it is performed a translation process in which ECs are translated into a set of Cypher Query Language queries. We have defined some EC simplification methods that leverage the logic structure underlying SNOMED CT. The purpose of these methods is to reduce the complexity of ECs and, in turn, its execution time, as well as to validate them from a SNOMED CT Concept Model and logical definition points of view. We also have developed a graphic representation based on the circle packing geometrical concept, which allows validating subsets, as well as pre-defined refsets and the terminology itself. RESULTS: We have developed SNQuery, a platform for the definition of intensional subsets of SNOMED CT concepts by means of the execution of ECs over a graph-oriented SNOMED CT database. Additionally, we have incorporated methods for the simplification and semantic validation of ECs, as well as for the visualization of subsets as a mechanism to understand and validate them. SNQuery has been evaluated in terms of EC execution times. CONCLUSION: In this paper, we provide methods to simplify, semantically validate and execute ECs over a graph-oriented database. We also offer a method to visualize the intensional subsets obtained by executing ECs to explore, understand and validate them, as well as refsets and the terminology itself. The definition of intensional subsets is useful to bind content between clinical information models and clinical terminologies, which is a necessary step to achieve semantic interoperability between EHR systems.

Cáncer de vesícula biliar ¿la contaminación por bilis afecta el pronóstico? / Gallbladder Cancer: does bile contamination affect the prognosis?

Resumen Introducción: En algunas áreas el cáncer de la vesícula biliar se detecta en hasta el 3,5% de los pacientes intervenidos por colelitiasis. Con el objetivo de evaluar el rol de la ruptura de la vesícula y la consiguiente contaminación por bilis, se evaluó una serie de pacientes portadores de cáncer de vesícula diagnosticado posterior a la colecistectomía. Materiales y Método: El estudio se efectuó en 109 pacientes en quienes se diagnosticó un cáncer de vesícula posterior a la colecistectomía. El grupo a estudiar se dividió de acuerdo a la ocurrencia o no de contaminación por bilis al momento de la colecistectomía, como también de acuerdo a la magnitud de ésta. Resultados: De los pacientes estudiados, en 32 se documentó la ocurrencia de contaminación por bilis al momento de la colecistectomía. De estos, en 13 la contaminación fue considerada mayor. El tiempo promedio de seguimiento fue de 33 meses, 35 pacientes (32,1%) fallecieron durante el seguimiento. La sobrevida media de la totalidad de la serie que tuvo contaminación por bilis no se diferenció de los pacientes sin contaminación. Sin embargo, el grupo que tuvo una contaminación catalogada como mayor, presentó una sobrevida estadísticamente inferior al resto de los pacientes. Finalmente, se realizó un análisis mediante el modelo de regresión de COX que incluyó edad, género, nivel de invasión y tipo de contaminación, resultando la existencia de contaminación mayor por bilis un factor independientemente asociado al pronóstico. Conclusión: La presencia de ruptura vesicular y contaminación mayor por bilis debiera considerarse un factor pronóstico.

Background: Incidental gallbladder cancer is observed in up to 3.5% of patients undergoing laparoscopic cholecystectomy. To study the role of wall perforation on the prognosis, we evaluated a series of patients in whom perforation occurred during the cholecystectomy. Materials and Method: 109 patients who underwent a laparoscopic cholecystectomy in whom final diagnosis was gallbladder cancer were the focus of the study. We divided the patients according the occurrence of spillage. Furthermore, patients with spillage were divided into two categories according the spillage magnitude. Results: Of the patients, spillage was documented in 32 (29.3%). In 13 patients spillage was considered major. The median follow-up of patients was 36 months, while 35 (32.1%) patients died during the follow-up. Five-year survival of all patients with spillage was not statistically different from the group without spillage. However, the group with major spillage had a statistically worse survival than the rest. A Cox regression analysis including age, gender, level of invasion and spillage category showed that major spillage was independently associated with a worse prognosis.

Técnica de linfadenectomía y resección del lecho vesicular laparoscópica por cáncer vesícula biliar incidental / Lymphadenectomy technique and laparoscopic vesicular bed resection for incidental gallbladder cancer

Resumen El cáncer de vesícula es infrecuente a nivel mundial, a diferencia de su alta incidencia en Chile. Su pronóstico es malo en general, y dependerá de su forma de presentación, siendo mejor en los casos diagnosticados después de una colecistectomía laparoscópica por patología benigna. La reintervención, que incluye la resección hepática y linfadenectomía, es el pilar de la terapia curativa en esta neoplasia. Presentamos la descripción de la técnica quirúrgica realizada en los pacientes con cáncer de vesícula de diagnóstico incidental, en el Servicio de Cirugía de Clínica Alemana de Santiago y en el Hospital de la Fuerza Aérea de Chile. El abordaje laparoscópico representa una alternativa quirúrgica válida en el tratamiento de pacientes con cáncer de vesícula biliar diagnosticados después de la colecistectomía. La estandarización de la técnica debiera contribuir a su mayor empleo y a la obtención de buenos resultados desde un punto de vista oncológico.

Gallbladder cancer is considered an infrequent disease but in Chile has a higher incidence. Prognostic is considered dismal except in those patients in whom the diagnosis is performed after the cholecystectomy specimen study. Reoperation with gallbladder bed resection and lymphadenectomy is considered the treatment in patients with incidental cases. We show the way this operation is performed in Clinica Alemana of Santiago and in the Air Force Hospital. The laparoscopic approach is an alternative to those patients in whom the diagnosis was done after the cholecystectomy. Laparoscopy allows to accomplish same objectives and to obtain identical results that the open approach. The technical standardization should contribute to spread its employment and to improve the results.

Implementation of an Execution Engine for SNOMED CT Expression Constraint Language.

The need to achieve high levels of semantic interoperability in the health domain is regarded as a crucial issue. Nowadays, one of the weaknesses when working in this direction is the lack of a coordinated use of information and terminological models to define the meaning and content of clinical data. IHTSDO is aware of this problem and has recently developed the SNOMED CT Expression Constraint Language to specify subsets of concepts. In this paper, we describe an implementation of an execution engine of this language. Our final objective is to allow advanced terminological binding between archetypes and SNOMED CT as a fundamental pillar to get semantically interoperable systems. The execution engine is available at http://snquery.veratech.es.

Resolución exitosa de la estenosis congénita de las dos ramas de la arteria pulmonar en un adulto mediante el uso de stents / Successful resolution of congenital stenosis of the two branches of the pulmonary artery in an adult using stents

La estenosis de las arterias pulmonares son rara vez diagnosticadas en edad adulta, convirtiéndose su tratamiento en una compleja situación con diferentes posibilidades terapéuticas. Las causas mas frecuentes corresponden a las adquiridas, siendo las mas común la hipertensión pulmonar trombo embólica crónica, quedando reducido numero de casos congénitos asociado principalmente a síndrome genéticos y malformaciones cardiacas asociadas. El tratamiento quirúrgico convencional puede convertirse en un desafío dadas las condiciones anatómicas y funcionales encontradas en estadios avanzados propias del diagnostico tardío y en especial en el caso presentado el cual esta iniciando la sétima década de la vida. La posibilidad de resolución percutánea de estas lesiones cobra importancia a la luz de la amplia utilización de esta en pacientes pediátricos, implementando el uso cada vez mayor de balones con dilatación percutánea y la utilización de stents cada vez más sostificados con buenos resultados. Se presenta nuestro primer caso de resolución percutánea de lesiones coronarias y de arteria pulmonar bilateral en un paciente previamente programado para cirugía de reparación con parche y by pass coronario, el cual evolucionó en formas satisfactoria recobrando su actividad normal a las pocas horas del procedimiento.

Stenosis of the pulmonary arteries is rarely diagnosed in adulthood, turning their treatment in a complex situationwith different therapeutic possibilities. The most frequent causes are acquired, being the most common chronicthromboembolic pulmonary hypertension, remaining a small number of congenital cases mainly associated to geneticsyndromes or complex cardiac malformations. The standard surgical treatment may be a challenge given the anatomicaland functional conditions found themselves in advanced stages of late diagnosis and especially in the case presented,who is beginning the seventh decade of his life. The possibility of percutaneous resolution of these lesions becomesimportant in light of the widespread use of this option in pediatric patients, implementing and increasing its use withpercutaneous dilatation balloons and stents with increasing sophistication and showing good results. We present ourfirst case of percutaneous resolution of coronary lesions and bilateral pulmonary artery stenosis in a patient previouslyscheduled for patch repair surgery and coronary bypass, which evolved in successfully, gaining normal activity within fewhours of the procedure.

Colecistectomía laparoscópica por puerto umbilical asistido / Transumbilical laparoscopic cholecystectomy assisted with a second port: experience in 60 patients

Background: Transumbilical laparoscopic surgery offers substantial esthetic benefits. The use of a second port to introduce a second trocar, reduces the need of special or articulated instruments. Aim: To report the experience with transumbilical cholecystectomy, assisted using a second port, to reduce technical complexity. Patients and Methods: The surgical technique was prospectively evaluated in 60 patients aged 18 to 77 years (39 women), that required a cholecystectomy. All had a surgical risk classified according to the American Society of Anesthesiologists (ASA) as I or II. Patients with gallbladder cancer, choledocholithiasis, were excluded. Two trocar (10 and 5 mm) were introduced by transumbilical incision and other one 5 mm trocar was introduced in the right iliac fossa for 0° frontal optics. Results: The mean operative time was 72 minutes (range 35-165). Fifty seven patients had a 24 h hospital stay. Two patients had to be converted to open surgery due to a complex pedicle dissection and one patient required an additional trocar. There were three complications. An umbilical seroma, a bile leakage through a Luschka duct, that was managed conservatively and one bile tract stenosis, that appeared four months after the operation and required surgical repair. Conclusions: Transumbilical cholecystectomy using a second additional port was a successful procedure, with similar esthetic results as single port surgery, but less costly.

Introducción: La cirugía laparoscópica evoluciona hacia técnicas menos invasivas, entre ellas la cirugía por puerto único umbilical, con mayor beneficio estético. El objetivo del presente trabajo es presentar los resultados de una técnica en colecistectomías laparoscópicas por puerto umbilical asistido por segundo puerto. La hipótesis planteada es que la técnica descrita es sencilla, segura y con beneficio estético similar al puerto único umbilical. Pacientes y Métodos: Técnica quirúrgica realizada prospectivamente en una serie de 60 pacientes ASA I y ASA II con consentimiento informado. Se incluye colecistolitiasis, pólipos, colecistitis aguda y crónica. Se excluye cáncer vesicular y coledocolitiasis. No se excluyeron casos por complejidad técnica o IMC. Se insertan 2 trocares de trabajo de 10 y 5 mm por incisión transumbilical y trocar de 5 mm en fosa iliaca derecha para óptica frontal de 0°. Resultados: Tiempo operatorio promedio de 72 minutos, mediana de 60 y extremos de 35 y 165. Tuvieron hospitalización de 24 horas 57 pacientes (95 por ciento). Hubo 2 conversiones a cirugía abierta por difícil disección del pedículo y un caso requirió trocar adicional. Hubo 3 complicaciones: un seroma de ombligo, una bilirragia por conducto de Luschka manejado conservadoramente y 1 estenosis de vía biliar postoperatoria a 4 meses, con reparación quirúrgica. Conclusiones: La colecistectomía lapa-roscópica por puerto umbilical asistida, logra resultados exitosos y con similares ventajas estéticas que el puerto único. El bajo costo de nuestra técnica permite realizarla en hospitales públicos y centros privados con menores recursos.

Disminución de las necesidades de sangre alogénica en cirugía protésica de rodilla mediante la reinfusión de sangre recuperada y procesada / Reduced allogenic transfusion requirements through reinfusion of processed shed blood

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Validation of the Spanish version of the SCOFF questionnaire for the screening of eating disorders in primary care.

OBJECTIVE: To assess the performance of the Spanish version of a new screening tool (the SCOFF) for the detection of eating disorders (EDs) in primary care. DESIGN: validation study. The psychiatric interview Schedules for Clinical Assessment in Neuropsychiatry (SCAN) was used as the "gold standard." Blinding was applied to administration of the SCOFF and the clinical interview. SETTING: six primary health care centers in Zaragoza and Huesca, Spain. PARTICIPANTS: 203 female patients, between the ages of 15 and 53 years, with a probable diagnosis of ED. MAIN OUTCOME MEASURE: validity as assessed by sensitivity, specificity, positive predictive value and negative predictive value. In addition, test-retest reliability and the receiver operating characteristics (ROC) curve were calculated. RESULTS: The best threshold point in the Spanish version was 2+ positive answers, the same as that recommended in the original British study. This cutoff point provided 97.7% sensitivity and 94.4% specificity for the detection of EDs in primary care. For each specific ED, sensitivity and specificity with this threshold point were, respectively, the following: bulimia, 97.8% and 94.4%; anorexia, 93.1% and 94.4%; and ED not otherwise specified (EDNOS), 100% and 94.4%. CONCLUSIONS: The Spanish version of the SCOFF questionnaire shows excellent psychometric properties for the early detection of EDs in primary settings.

Perioperative stimulation of erythropoiesis with intravenous iron and erythropoietin reduces transfusion requirements in patients with hip fracture. A prospective observational study.

BACKGROUND AND OBJECTIVES: Patients undergoing surgery for hip fracture (HF) often receive perioperative allogeneic blood transfusions (ABT) to avoid anaemia. However, concerns about the adverse effects of ABT have prompted the review of transfusion practice and the search for a safer treatment of perioperative anaemia. MATERIALS AND METHODS: We prospectively investigated the effect of a blood-saving protocol of perioperative iron sucrose (3 x 200 mg/48 h, intravenously) plus erythropoietin (1 x 40,000 IU, subcutaneously) if admission haemoglobin level < 130 g/l, on transfusion requirements and postoperative morbid-mortality in patients with HF (group 2; n= 83). A parallel series of 41 HF patients admitted to another surgical unit within the same hospital served as the control group (group 1). Perioperative blood samples were taken for haematimetric, iron metabolism and inflammatory parameter determination. RESULTS: This blood-saving protocol reduced the number of transfused patients (P < 0.001), the number of transfused units (P < 0.0001), increased the reticulocyte count and improved iron metabolism. In addition, the blood-saving protocol also reduced the rate of postoperative infections (P = 0.016), but not the 30-day mortality rate or the mean length of hospital stay. CONCLUSIONS: The blood-saving protocol implemented seems to reduce ABT requirements in patients with HF, and is associated with a lower postoperative morbidity. The possible mechanisms involved in these effects are discussed.

Investigación de reservorios de Bartonella Bacilliformis / Reservoirs research of Bartonella Bacilliformis

La bartonelosis humana es una enfermedad causada por Bartonella bacilliformis a través de la picadura de insectos hematófagos del género Lutzomyia en zonas endémicas del Perú, Ecuador y Colombia. Se utilizaron 285 hemocultivos, de los cuales 200 pertenecían a humanos, 30 a perros caseros, 30 a cobayos y 25 a ratones silvestres, todos ellos procedentes de áreas verrucógenas del Perú. Se obtuvo 24 hemocultivos positivos (12 por ciento) a Bartonella bacilliformis en el grupo de los humanos, mientras que en los animales todos los hemocultivos fueron negativos. En consecuencia, pensamos que el único reservorio de Bartonella bacilliformis hasta la fecha es el hombre.

[Preoperative blood test results and type of fracture as transfusional risk factors in patients older than 65 years with trochanteric hip fracture]. / Valores hematimétricos preoperatorios y tipo de fractura como factores de riesgo transfusional en fracturas trocantéreas de cadera en pacientes mayores de 65 años.

OBJECTIVE: To determine the effect of risk factors for allogenic blood transfusion in surgery for trochanteric hip fractures. PATIENTS AND METHODS: A retrospective study of all the trochanteric hip fracture patients older than 65 years who underwent surgery to repair trochanteric hip fracture related to osteoporosis in 2000 and 2001 in a regional hospital. Data recorded were age; gender; type of fracture (international AO classification); level of anesthetic risk (ASA classification); hemoglobin concentration and hematocrit upon admission, on the day of surgery and 2 days later; time elapsing between admission and surgery; blood transfusion and blood product use. RESULTS: One hundred two patients (29 men and 73 women) with trochanteric hip fractures were studied. Mean (+/- SD) patient age was 82.9 +/- 8.8 years (range, 65-99 years). Upon admission, mean hemoglobin was 123 +/- 18.1 g/L (range, 56-154 g/L), hematocrit was 37% +/- 5% (range, 10%-40%). Time elapsing until surgery was 3.5 +/- 1.6 days (range, 0-8 days). Admission hemoglobin concentration was lower in patients who required transfusion (116 g/L) than in patients who did not (133 g/L) (P < 0.001). Logistical regression analysis identified only AO classification of fracture type (P < 0.05) and admission hemoglobin concentration (P < 0.001) as independent risk factors for transfusion. CONCLUSIONS: The hemoglobin level at admission and the trochanteric fracture type bear a relation to transfusion needs. These results suggest that in elderly patients we should improve hemoglobin levels and initiate blood salvage measures in order to reduce the need for allogenic blood transfusion, with its inherent risks.

Value of magnetic resonance imaging for the diagnosis and follow-up of haemophilic arthropathy.

An orthopaedic assessment of the joint status of seven severe haemophiliacs (mean age 12.5 y - range 8.9-15.5) on prophylactic treatment (PT) by magnetic resonance imaging (MRI) and physical examination was carried out. Median duration of PT of these patients was 84 months (range 32-107). A locally designed MRI joint score considering seven parameters (1 - joint effusion, 2 - synovial membrane thickening, 3 - haemosiderin deposits, 4 - joint cartilage injury, 5 - subchondral bone erosion, 6 - subchondral bone cysts, 7 - osteonecrosis) was used (maximum score = 13 points). MRI scans were performed in 17 joints (nine ankles, seven knees and one elbow): mean MRI scores for the affected joints was 5.1. A poor consistency between physical examination and MRI findings or the real extent of joint damage was found (Cohen kappa index 0.320). MRI is a precise non-invasive tool for the assessment of early joint cartilage and synovium pathological changes still undetectable by physical examination or conventional X-rays in the haemophilic setting.

[Preoperative hemoglobin as the only predictive factor of transfusional needs in knee arthroplasty]. / La hemoglobina preoperatoria como único factor predictor de las necesidades transfusionales en la artroplastia de rodilla.

OBJECTIVE: To study transfusion requirements in total knee anthroplasty (TKA) in order to estimate needs and consider possible ways to improve principled management. PATIENTS AND METHODS: Retrospective study of all TKAs performed over a period of 3 months in 2000. We analyzed age, medication, hypertension, participation in a predeposit autologous blood program (PABP), drainage bleeding, transfusion requirements and hemoglobin (Hb) levels. RESULTS: One hundred ten TKAs were performed. Ten were excluded from analysis (2 TKA reviews, 5 patients with coronary artery disease and 3 with chronic bronchial diseases). We reserved a mean 2.46 +/- 0.5 units of packed red cells (range 2-3), and 30% of the patients were transfused with a mean 0.62 +/- 0.99 units (range 0-4). In 15 cases (50%), transfusions were not clearly indicated or were related only to the surgical procedure. All 5 PABP patients were transfused, but not with homologous blood, even through 4 had Hb levels over 9 g/dL. Only Hb level was an independent risk factor for transfusion. Transfusions were given to 80% of patients with Hb levels under 12 g/dL, to 18.8% of those with hemoglobin levels over 14 g/dL, and to 35.7% of those with Hb levels between 12 g/dL and 14 g/dL. CONCLUSIONS: Preoperative Hb level was the single predictor of transfusion in our series of patients. In some cases the transfusion trigger was too liberal. Alternatives to homologous transfusion were hardly used, with PABP applied in only 5% of the cases. These findings encourage us to continue trying to improve the PABP program and transfusion criteria, to introduce alternatives and to improve baseline Hb levels.

La hemoglobina preoperatoria como único factor predictor de las necesidades transfusionales en la artroplastia de rodilla / Preoperative hemoglobin level as the single predictor of transfusion requirements in total knee arthroplasty

OBJETIVO: Estudiar las necesidades transfusionales en cirugía ortopédica de artroplastia total de rodilla (PTR), al objeto de valorar el consumo y plantear posibles medidas racionalizadoras. MATERIAL Y MÉTODOS: Estudio retrospectivo de las PTR realizadas durante 3 meses. Se han analizado las variables edad, sexo, medicación, hipertensión arterial, medidas de ahorro, hemorragia por drenaje, consumo de hemoderivados y valores hematimétricos. RESULTADOS: Se realizaron 110 PTR, descartando 10 de ellas (2 casos de revisión, 5 pacientes afectos de cardiopatías isquémicas y 3 broncopatías crónicas). Se reservaron 2,46ñ0,5 concentrados de hematíes (CH) (extremos 2-3), transfundiendo al 30 por ciento de los pacientes, con una media de 0,62ñ0,99 CH (extremos 0-4). En cuanto al acto transfusional, en 15 (50 por ciento) no estaría claramente indicado o en relación sólo con el proceso quirúrgico. Cinco pacientes habían entrado en el programa de autotransfusión predepósito (ATP), siendo todos transfundidos, ninguno con sangre homóloga, aunque cuatro con un valor de hemoglobina (Hb) mayor de 9 g/dl. En nuestra serie sólo el valor de Hb previo fue un factor de riesgo independiente para ser transfundido. Se transfundió al 80 por ciento si la Hb era menor a 12 g/dl, al 18,8 por ciento si la Hb era mayor de 14 g/dl, y 35,7 por ciento si la Hb era superior a 12 g/dl e inferior a 14 g/dl. CONCLUSIONES: En nuestra serie la tasa de hemoglobina en el preoperatorio fue el único factor predictivo del riesgo transfusional en estos pacientes. Hallamos casos con criterio de transfusión excesivamente liberal, y una escasa utilización de medidas alternativas (sólo un 5 por ciento de ATP). Todo esto nos invita a continuar mejorando nuestro programa de ATP y los criterios transfusionales, instaurar medidas alternativas e implementar los valores hematológicos basales. (AU)

High-dose epirubicin plus docetaxel at standard dose with lenograstim support as first-line therapy in advanced breast cancer.

On the basis of preclinical and clinical data, we designed a phase II study to determine the efficacy and feasibility of high-dose epirubicin plus docetaxel (Taxotere) with lenograstim support, as first-line therapy for patients with advanced breast cancer. Patients with histologic evidence of metastatic breast cancer, without previous chemotherapy, adequate organ functions, Eastern Cooperative Oncology Group performance status less than 2, and signed informed consent entered in the trial. Treatment consisted of premedication the day before the treatment day for 3 consecutive days (dexamethasone 16 mg o.r. and 5-HT3 antagonists). On the treatment day 1, epirubicin 130 mg/m2 was administered as a 15-minute intravenous infusion followed 1 hour later by 1-hour intravenous infusion of docetaxel 100 mg/m2. Cycles were repeated every 21 days, for a maximum of 8 cycles. Lenograstim (5 microg/kg, s.c.) was started 48 hours later (day 4) and was given daily for 10 consecutive days. Response evaluation was made after the third cycle was applied, following World Health Organization criteria. Responding patients received five additional cycles. Median time to progression and survival were calculated according to the Kaplan-Meier method. A total of 32 patients have been included in the study. A total of 236 courses were delivered. A total response rate of 87.5% (95% confidence interval [CI] of 77-98) was obtained. There were 11 complete responses and 17 partial responses. Toxicity was mild, with a low incidence of undesirable effects (7 cycles, 2.9% were delayed from 3 to 6 days because of neutropenia). After a median follow-up time of 490 days (range, 131-966 days), the median time to progression was 490 days (95% CI 314-575), and the median survival was 604 days (95% CI 513-785). This epirubicin plus docetaxel regimen is an efficient treatment for patients with advanced breast cancer. The lenograstim support allows the administration of such a chemotherapy regimen with a modest incidence of side effects. A larger number of patients need to be evaluated.

Phase III randomized trial of toremifene vs tamoxifen in hormonodependant advanced breast cancer.

PURPOSE: Efficacy and safety of toremifene (TOR) 60 mgs/dayly/o.r. was compared with tamoxifen (TAM) 40 mgs/dayly/o.r. in a group of postmenopausal women with advanced breast cancer, without previous systemic therapy for advanced breast cancer. MATERIAL AND METHODS: The study was a prospective double-blind randomized trial. All treated patients presented with positive estrogen receptors. Main end points were response rates, toxicity profile analysis, time to progression and survival. WHO and ECOG criteria were employed for response evaluation while toxicity was assesed according to WHO guidelines. Curves were constructed by means of Kaplan-Meier methodology and were compared by means of log-rank test. RESULTS: From January 1996 to January 1999 a total of 217 patients were included in the study (106 in the TOR branch and 111 in the TAM arm). Both groups of patients were homogeneous regarding the main prognostic factors. A response rate of 64% (68/106) was observed in the TOR group as compared with a 52% (58/111) in the TAM group. Median times to progression and overall survival were not significantly different. A lower incidence of undesirable effects was apreciated in the TOR arm. CONCLUSIONS: Our data suggest that TOR is an efficient and well-tolerated agent for the therapy of postmenopausal women with hormonal positive receptors advanced breast cancer, and must be considered an alternative to TAM as first line therapy for ER+ advanced breast cancer patients and as well as an adjuvant treatment.

Aneurismas de aorta abdominal. Evolución asistencial y quirúrgica en una comunidad durante 20 años

Objetivos: Estudio de la evolución asistencial, formas clínicas de presentación y resultados del tratamiento quirúrgico de los Aneurismas de Aorta Abdominal, durante un periodo de 20 años en la Comunidad Asturiana. Material y métodos: Análisis retrospectivo de 899 pacientes intervenidos de aneurismas, 203 (22,5 por ciento) urgentes y 696 electivos (77,5 por ciento) entre 1980-1998. Estudio evolutivo tanto en sus formas de presentación clínica como en su relación con el resto de la actividad quirúrgica. Resultados: El número de aneurismas operados anualmente de forma electiva ha aumentado un 256 por ciento en el periodo analizado. La cirugía urgente ha aumentado también un 34 por ciento, estabilizándose en los últimos 5 años. La mortalidad electiva ha descendido del 7,6 por ciento en el subperiodo 1980-1985 al 3,2 por ciento en los últimos 6 años. La de la urgente permanece por encima del 50 por ciento en ambos periodos. El número de aneurismas aórticos operados anualmente de forma urgente no ha disminuido en términos absolutos pero si de forma significativa en la relación urgentes/electivos, pasando del 33,7 por ciento (67/199) entre 1980-1990 al 19,5 por ciento (136/700) entre 1991-1998. La cirugía sobre los aneurismas ha pasado del 8 al 50 por ciento del total de cirugía aórtica y del 1,4 al 6,8 por ciento del total de intervenciones llevadas a cabo entre ambos períodos. Conclusiones: Se constata el aumento de la cirugía sobre los aneurismas aórticos en la Comunidad Asturiana en los últimos 20 años, muy especialmente en los operados de forma electiva. La cirugía urgente permanece estable en los últimos años. Es imprescindible llevar a cabo estrategias de salud con la colaboración de los médicos de Atención Primaria para el control de la enfermedad, cuya prevalencia aumentará en los próximos años en función del mantenido y previsible envejecimiento poblacional (AU)