Coste económico directo del control y el tratamiento del lupus eritematoso sistémico activo y sus brotes en España: estudio LUCIE / Direct cost of management and treatment of active systemic lupus erythematosus and its flares in Spain: the LUCIE Study

Fundamento y objetivo. El coste del control y el tratamiento del lupus eritematoso sistémico (LES) en España es desconocido. El objetivo del estudio fue describir los recursos sanitarios asociados al control y el tratamiento del LES y sus brotes, y estimar el coste directo asociado. Pacientes y método. Estudio retrospectivo (2008-2010) europeo con participación de 5 centros españoles con experiencia en LES. Se incluyeron pacientes adultos con LES (criterios ACR) con autoanticuerpos positivos (ANA y/o anti-ADN nativo), en tratamiento médico y enfermedad activa. Los pacientes se estratificaron en graves y no graves. Los costes sanitarios directos se estimaron a partir de los recursos utilizados y de sus costes unitarios. Resultados. Se analizaron 75 de 79 pacientes españoles incluidos (52% graves). El 91,9% fueron mujeres y el 90,7% caucásicos. La edad media (DE) fue de 41 (14,5) años. El coste anual por paciente asociado al LES fue de 5.968€ (7.038) y 3.604€ (5.159) en pacientes graves y no graves, respectivamente (p=0,002). Los costes asociados con hospitalizaciones, tratamiento farmacológico, visitas al especialista y pruebas de laboratorio fueron superiores en pacientes con LES grave. El 90,7% de los pacientes presentó, al menos, un brote en 2 años. Los brotes graves fueron un predictor significativo del incremento del coste. Conclusiones. El coste asociado al control y el tratamiento del LES es mayor en pacientes con LES grave. El insuficiente control de la actividad de la enfermedad se traduce en la aparición de brotes, cuya presencia se relaciona con un incremento de costes, siendo los relativos a las hospitalizaciones el componente mayoritario(AU)

Background and objective. The cost of control and management of Systemic Lupus Erythematosus (SLE) in Spain is unknown. This study has aimed to describe the healthcare resources associated to control and treatment of LES and its flares and to estimate the associated direct costs. Patients and methods. This was a European, multicentric, retrospective study (2008-2010) carried out with the participation of 5 hospitals in Spain with experience in SLE. Adult SLE patients (ACR criteria), with positive auto-antibodies (ANA and/or anti-ds-DNA) and active disease were included. Patients were stratified into severe and non-severe SLE. Direct healthcare costs were estimated with resources used and their unit costs. Results. Seventy-five out of 79 SLE patients were analyzed. Of these, 52% had severe disease, 91.9% were females and 90.7% were Caucasian. Mean (SD) age was 41.0 (14.5) years. Annual direct cost per patient related to SLE management was €5,968 (7,038) and €3,604 (5,159) for severe and non-severe patients, respectively (P=.002). Costs related to hospitalizations, pharmacological treatment, visits to specialists, and laboratory tests were higher for patients with severe disease. At least one flare during the observation period was present in 90.7% of patients. Severe flares were a significant predictor of increase in cost. Conclusions. The cost associated with SLE control and treatment is higher for severe SLE patients. Insufficient control of the disease activity results in an increase in flares. Its presence is related to an increase in costs, hospitalization being the major component(AU)

Direct cost of management and treatment of active systemic lupus erythematosus and its flares in Spain: the LUCIE Study.

BACKGROUND AND OBJECTIVE: The cost of control and management of Systemic Lupus Erythematosus (SLE) in Spain is unknown. This study has aimed to describe the healthcare resources associated to control and treatment of LES and its flares and to estimate the associated direct costs. PATIENTS AND METHODS: This was a European, multicentric, retrospective study (2008-2010) carried out with the participation of 5 hospitals in Spain with experience in SLE. Adult SLE patients (ACR criteria), with positive auto-antibodies (ANA and/or anti-ds-DNA) and active disease were included. Patients were stratified into severe and non-severe SLE. Direct healthcare costs were estimated with resources used and their unit costs. RESULTS: Seventy-five out of 79 SLE patients were analyzed. Of these, 52% had severe disease, 91.9% were females and 90.7% were Caucasian. Mean (SD) age was 41.0 (14.5) years. Annual direct cost per patient related to SLE management was €5,968 (7,038) and €3,604 (5,159) for severe and non-severe patients, respectively (P=.002). Costs related to hospitalizations, pharmacological treatment, visits to specialists, and laboratory tests were higher for patients with severe disease. At least one flare during the observation period was present in 90.7% of patients. Severe flares were a significant predictor of increase in cost. CONCLUSIONS: The cost associated with SLE control and treatment is higher for severe SLE patients. Insufficient control of the disease activity results in an increase in flares. Its presence is related to an increase in costs, hospitalization being the major component.

When should re-consent of subjects participating in a clinical trial be requested? A case-oriented algorithm to assist in the decision-making process.

Investigators, sponsors, and institutional review boards have to decide when re-consent of clinical trials' participants must be obtained when new information becomes available. We present an algorithm to help in the decision-making process, which takes into consideration the kind of new information, the risk of exposure (patients could be on the treatment or in the follow-up phases), and the possibility of managing the case. Re-consent should be obtained in three of the eight possible situations.

Varón de 79 años con nódulos pulmonares bilaterales cavitados / 79 year old male with bilateral cavitary pulmonary nodules

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Datos y reflexiones sobre el proceso actual de evaluación de ensayos clínicos multicéntricos en España / Data and reflection on the current process of evaluation of multicenter clinical trials in Spain

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ANCA-associated vasculitis as paraneoplastic syndrome with colon cancer: a case report.

Coexistence of a vasculitis and a neoplastic disease is rare and the pathogenesis is unknown. Most of these associations refer to leukocytoclastic or poliarteritis nodosa (PAN)-type vasculitis and hematological malignancies. There are few reports of vasculitis in patients with solid tumours and there are also few reports of paraneoplastic ANCA-associated vasculitis. We report a case of p-ANCA-positive vasculitis with peripheral nerve involvement associated with a colon cancer. Vasculitis resolved after corticoid treatment and surgical removal of the tumour.

Lumbalgia y hernia de Petit / Low-back pain and "Petit's hernia"

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Carpintero con fiebre y dolor cervical / Carpenter with fever and cervical pain

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Clinical characteristics and response to newer quinolones in Legionella pneumonia: a report of 28 cases.

Twenty-eight (11.6%) out of 241 Spanish patients enrolled in an international phase III clinical trial of mild to moderate community-acquired pneumonia (CAP) comparing gemifloxacin vs. trovafloxacin were diagnosed of Legionnaires' disease. A definite diagnosis was established by seroconversion in 13 patients of whom only 2 had a positive Legionella urinary antigen. The remaining 15 patients were possible Legionella infections based on a single elevated IgG titer (> or = 1:512). All patients had a radiologically confirmed diagnosis of pneumonia, 5 (19%) patients were older than 65, comorbidity was present in 9 (33%), and 10 (36%) had to be hospitalized. Fifteen patients were treated with oral gemifloxacin (320 mg/day) and 13 with oral trovafloxacin (200 mg/day). Overall, clinical success occurred in 25 (89.3%) patients after 7 days of treatment and only 1 patient needed a 14-day treatment. There were only one adverse event withdrawal and one clinical failure, and no patients died. In light of the favorable clinical outcome, the use of newer fluoroquinolones seems adequate for the treatment of suspected or proven Legionella pneumonia.

[Multiple paraganglioma: careful with surgery!]. / Paraganglioma multicéntrico: cuidado con la cirugía.

INTRODUCTION: Extraadrenal paragangliomas are exceptional tumors. They prevail the carotid, jugulotympanic, and vagal ones. They are frequently multiple and its treatment is controversial in view of the fact that bilateral removal can go with severe morbidity. The case of a patient with bilateral paraganglioma and postoperative baroreflex dysfunction with severe arterial hypertension and hypotension episodes is presented. CLINICAL OBSERVATION: A 23-year-old woman with a diagnosis of left carotid and right vagal paraganglioma by TC and angiography. In January 1999 the left carotid paraganglioma was operated. The patient showed dysphonia, dysphagia, and lingual dysmotility in the postoperative course, with spontaneous improvement after some months. In December 1999, after the removal of the right vagal paraganglioma, the same complications appeared and hypertension crises (230/140), associated with headache, dizziness, and rash, and alternating with severe hypotension episodes (70/50). Blood biochemistry and the levels of cortisol, thyroid hormones, catecholamines, and metabolites were normal. Imaging techniques discarded tumor at another level and the registry of the ambulatory monitoring of blood pressure (AMBP) confirmed an important pressure lability. The neurophysiological study of the autonomous nervous system demonstrated the failure of the fast regulation mechanisms of the blood pressure. With the diagnosis of baroreceptors dysfunction and paralyses of cranial nerves IX, X and XII a treatment with clonidine was started with poor tolerability and incomplete response. DISCUSSION: This case illustrates the treatment difficulties of paragangliomas, especially when they are bilateral, and in which the surgery can go with severe morbidity. Baroreflex dysfunction should be entertained in the differential diagnosis of the extreme pressure lability.

Paraganglioma multicéntrico: cuidado con la cirugía / Multiple paraganglioma: careful with surgery!

Introducción. Los paragangliomas extraadrenales son tumores excepcionales. Predominan los carotídeos, yugulotimpánicos y vagales. Con frecuencia son múltiples y su tratamiento es motivo de controversia dado que la extirpación bilateral puede acompañarse de importante morbilidad. Se presenta el caso de una paciente con paraganglioma bilateral y disfunción barorrefleja posquirúrgica que le ocasionaba crisis de hipertensión e hipotensión arterial severas. Observación clínica. Mujer de 23 años diagnosticada de paraganglioma carotídeo izquierdo y vagal derecho por tomografía computarizada (TC) y angiografía. En enero de 1999 fue intervenida del paraganglioma carotídeo izquierdo. En el postoperatorio presentó disfonía, disfagia y dismotilidad lingual, con mejoría espontánea en unos meses. En diciembre de 1999, tras la extirpación del paraganglioma vagal derecho, presentó las mismas complicaciones y crisis de hipertensión arterial (230/140 mmHg) acompañadas de cefalea, mareo y rash, alternando con episodios de hipotensión severa (70/50 mmHg).La analítica general y las determinaciones de cortisol, hormonas tiroideas, catecolaminas y metabolitos fueron normales. Las pruebas de imagen descartaron tumor a otro nivel y el registro de la monitorización ambulatoria de presión arterial (MAPA) confirmó una importante labilidad tensional. El estudio neurofisiológico del sistema nervioso autónomo demostró fallo de los mecanismos de regulación rápida de la tensión arterial. Con el diagnóstico de disfunción de barrorreceptores y parálisis de pares craneales IX, X y XII se inició tratamiento con clonidina con mala tolerancia y respuesta incompleta. Discusión. La paciente ilustra la dificultad de tratar los paragangliomas, especialmente si son bilaterales, en los cuales la cirugía puede ocasionar una morbilidad importante. La disfunción del barorreflejo debe ser considerada en el diagnóstico diferencial de la labilidad tensional extrema (AU)

Un paciente con anemia

La anemia se define como la disminución de la concentración de hemoglobina por debajo de unos límites considerados normales para un determinado grupo de individuos de la misma edad, sexo y condiciones medioambientales. La existencia de un síndrome anémico es uno de los problemas diagnósticos más frecuentes en la práctica clínica y, en ocasiones, puede resultar una tarea difícil. Con este trabajo se pretende proporcionar unas pautas a seguir en el estudio del paciente anémico (AU)