[Protocol for prevention and treatment of osteoporosis in patients with cystic fibrosis]. / Efectividad en la aplicación de tres protocolos de prevención y tratamiento de la osteoporosis en pacientes adultos con fibrosis quística.

BACKGROUND AND OBJECTIVE: Reduction of bone mineral density (BMD) is a complication of cystic fibrosis (CF) which is observed in parallel to the increment of life expectancy in these patients. The aim of this study was to analyze the evolution of BMD following the application of a protocol for the prevention and treatment of osteoporosis. PATIENTS AND METHOD: We performed a multidisciplinary prospective study in 21 adult patients with CF with a mean age of 24.3 (r: 19-44) years. We evaluated BMD results depending on the treatment schedule, and the annual relative change of BMD percentage was correlated with changes observed in respiratory function, corporal mass index (CMI), Brasfield radiologic score and Shwachman clinical score for a 3 years follow up period. Three regimens of treatment were applied: general measurements, supplementation of calcium and vitamin D, and 10 daily mg of alendronate plus calcium and vitamin D supplements. RESULTS: Basal assessment showed that 14.2% of CF patients had a marked diminution of bone mass with respect to an age and sex matched control population, with a Z score of < -2 DE in lumbar vertebral and/or total femur. Another 38% showed a lessening of Z score between -1 and -2.5 DE. We observed a progressive annual reduction of BMD in all the anatomic areas analyzed: -0.52% (1.87) in lumbar spine, -1.17% (1.91) in total femur and -2.16% (2.65) in neck femur. The hip BMD annual decrement was related to that observed in FEV1. Only patients treated with alendronate did not suffer progressive BMD lose. Treatment with a combination of calcium, vitamin D and alendronate was more efficient in hip BMD than calcium plus vitamin D alone (p < 0.05). Also, this combination was better than no treatment at hip and femoral neck levels (p < 0.05). CONCLUSIONS: Our work confirms that Spanish young adults patients with CF show low control matched BMD, and that it even worsens at follow-up. This decrement is not adequately halted with preventive treatment with supplements of calcium and vitamin D, and only patients treated with alendronate show increments of their BMD.

Efectividad en la aplicación de tres protocolos de prevención y tratamiento de la osteoporosis en pacientes adultos con fibrosis quística / Protocol for prevention and treatment of osteoporosis in patients with cystic fibrosis

Fundamento y objetivo: La disminución de la densidad mineral ósea (DMO) es una complicación de la fibrosis quística (FQ) que se observa al aumentar la esperanza de vida de estos pacientes. El objetivo del presente estudio ha sido valorar la evolución de la DMO tras la instauración de un protocolo de prevención y tratamiento de la osteoporosis. Pacientes y método: Realizamos un estudio prospectivo en 21 pacientes adultos (10 mujeres y 11 varones) con FQ de una unidad multidisciplinaria, con una edad media de 24,3 años (extremos, 19-44). Se evaluaron los resultados de la DMO según los diferentes tratamientos administrados y se relacionó el cambio relativo anual en el porcentaje de la DMO con los observados en la función pulmonar, índice de masa corporal y puntuaciones radiológica de Brasfield y clínica de Shwachman, durante un período de seguimiento medio de 3 años. Las 3 pautas de tratamiento instauradas fueron: medidas preventivas generales, suplementos de calcio y vitamina D, y alendronato a dosis de 10 mg diarios con suplementos de calcio y vitamina D. Resultados: Inicialmente se observó que el 14,2% de los pacientes con FQ presentaban una disminución acusada de la masa ósea respecto a la población control de su misma edad y sexo, con una puntuación Z inferior a ­2 desviaciones estándar en columna lumbar y/o fémur total. Otro 38% presentaban descensos de la puntuación Z entre ­1 y ­2 desviaciones estándar. La disminución anual progresiva de la DMO durante los 3 años fue generalizada en todas las áreas anatómicas analizadas: ­0,52% (1,87) en columna lumbar, ­1,17% (1,91) en fémur total y ­2,16% (2,65) en cuello de fémur. En fémur el porcentaje de cambio relativo anual de DMO se relacionó con el observado en el volumen espiratorio forzado en el primer segundo (p < 0,05). Sólo los pacientes tratados con alendronato no sufrieron pérdida progresiva de masa ósea. El tratamiento con calcio, vitamina D y alendronato fue más eficaz para prevenir la disminución de la DMO en fémur total y cuello femoral que las medidas preventivas generales (p < 0,05) y en fémur total fue más eficaz que los suplementos de calcio con vitamina D (p < 0,05). Conclusiones: Nuestro trabajo confirma que los pacientes adultos jóvenes españoles con FQ tienen una disminución de la DMO respecto a la población control y que, a lo largo de la enfermedad, esta disminución es progresiva. Esta pérdida de masa ósea no se previene con medidas generales ni con suplementos de calcio y vitamina D, y únicamente en los pacientes tratados con alendronato se produce un aumento de la DMO

Background and objective: Reduction of bone mineral density (BMD) is a complication of cystic fibrosis (CF) which is observed in parallel to the increment of life expectancy in these patients. The aim of this study was to analyze the evolution of BMD following the application of a protocol for the prevention and treatment of osteoporosis. Patients and method: We performed a multidisciplinary prospective study in 21 adult patients with CF with a mean age of 24.3 (r: 19-44) years. We evaluated BMD results depending on the treatment schedule, and the annual relative change of BMD percentage was correlated with changes observed in respiratory function, corporal mass index (CMI), Brasfield radiologic score and Shwachman clinical score for a 3 years follow up period. Three regimens of treatment were applied: general measurements, supplementation of calcium and vitamin D, and 10 daily mg of alendronate plus calcium and vitamin D supplements. Results: Basal assessment showed that 14.2% of CF patients had a marked diminution of bone mass with respect to an age and sex matched control population, with a Z score of < ­2 DE in lumbar vertebral and/or total femur. Another 38% showed a lessening of Z score between ­1 and ­2.5 DE. We observed a progressive annual reduction of BMD in all the anatomic areas analyzed: ­0.52% (1.87) in lumbar spine, ­1.17% (1.91) in total femur and ­2.16% (2.65) in neck femur. The hip BMD annual decrement was related to that observed in FEV1. Only patients treated with alendronate did not suffer progressive BMD lose. Treatment with a combination of calcium, vitamin D and alendronate was more efficient in hip BMD than calcium plus vitamin D alone (p < 0.05). Also, this combination was better than no treatment at hip and femoral neck levels (p < 0.05). Conclusions: Our work confirms that Spanish young adults patients with CF show low control matched BMD, and that it even worsens at follow-up. This decrement is not adequately halted with preventive treatment with supplements of calcium and vitamin D, and only patients treated with alendronate show increments of their BMD

[A study of bone mineral density in adult patients with cystic fibrosis]. / Estudio de la densidad mineral ósea en pacientes adultos con fibrosis quística.

BACKGROUND AND OBJECTIVE: Due to recent medical advances, patients with cystic fibrosis (CF) can expect longer survival rates and, as a result, face previously unreported complications such as osteoporosis. Our goal was to determine the mineral bone density in young adult patients with CF attended in the adult CF Unit, and correlate these findings with other clinical variables of interest in this patient population. PATIENTS AND METHOD: We carried out a transversal study from 1999 to 2002 of 34 patients with CF (19 males and 15 females. Mean age 23 years). Upon enrollment in the study, patient gender and age were recorded along with Schwachman and Brasfield scores, pulmonary function test results (spirometry) and sputum analysis, phosphorus and calcium balance, vitamin D intake, and dual energy X-ray absorptiometry (DEXA) findings of the spinal column (L2-L4) and femur. RESULTS: 54.5% of all study patients were found to have an abnormal mineral bone density. Fifteen patients met criteria for osteopenia and 3 for osteoporosis. Age, treatment with inhaled corticosteroids, and pulmonary function test results correlated with bone density. CONCLUSIONS: DEXA scans should be performed in young adults with CF at least once during the course of their illness on the basis of the high prevalence of mineral bone density abnormalities in this population.

Rapid D-dimer test combined a clinical model for deep vein thrombosis. Validation with ultrasonography and clinical follow-up in 383 patients.

An optimal approach to the diagnosis of deep vein thrombosis (DVT) in lower limbs in the emergency department is still unknown. In this prospective cohort study, we aimed to evaluate the accuracy of the widely available plasma D-dimer test (VIDAS) and establish the usefulness of combining D-dimer testing with a clinical model to reduce the need for serial ultra-sonographies and improve the diagnostic strategy of DVT. We performed a cohort study in 383 consecutive outpatients referred to the emergency department of Hospital La Princesa, with clinical suspicion of DVT. The patients were stratified into three pre-test probability categories using an explicit clinical model (Wells score), and underwent a quantitative automated ELISA D-dimer assay (VIDAS D-Dimer bioMérieux). Patients were managed according to the diagnostic strategy based on clinical probability and compression ultrasonography (CU). Patients for whom DVT was considered a high pre-test probability with negative ultrasonographic findings in the initial CU, returned the following week for repeat ultrasonography. All patients with DVT excluded did not receive anticoagulant therapy, and were followed up for three months to monitor the development of venous thromboembolic complications. DVT was confirmed in 102 patients (26.6%): 95 in the initial test, four in the second test, and three who developed venous thromboembolic complications in the three-month follow-up period. The calculated D-dimer cut-off level was 1 micro g/ml. One hundred patients (98%) with DVT had positive D-dimer. D-dimer had a sensitivity of 98% and a negative predictive value of 98.6%. Among the high-probability patients with positive D-dimer tests and initial negative CU, 9.75% had DVT on repeat CU at one week. The study results suggest that the addition of VIDAS D-dimer to this diagnostic algorithm could improve the management of patients with suspected DVT in daily practice. A diagnostic approach of DVT based on D-dimer (cut-off > or =1 microg/ml) as the first diagnostic tool for the exclusion of DVT, and the clinical probability model as the tool that identifies those patients requiring a second ultrasonography is useful and suitable for daily medical practice.

[Deep venous thrombosis of lower extremities in an Emergency Department. Utility of a clinical diagnosis model]. / Trombosis venosa profunda en miembros inferiores en un servicio de urgencias. Utilidad de un modelo clínico de estratificación de riesgo.

BACKGROUND: Deep vein thrombosis (DVT) is a difficult to diagnostic disease. The aim of this study was to determine the utility and accuracy of a risk stratification questionnaire and a diagnostic strategy, which were applied to patients with suspected DVT on lower extremities in an emergency department. PATIENTS AND METHOD: A prospective cohort study was performed in 569 outpatients with clinical suspected DVT during 14 months. The applied questionnaire stratified patients into three pre-test probability categories. Items included signs, symptoms, risk factors and potential alternative diagnosis, which were based on a modified Wells clinical model. DVT was diagnosed by the combined use of clinical model, compression ultrasonography (CUS) and follow-up CUS one week later in those moderate-high risk patients with an initial normal test. These patients were followed over three months for the development of venous thromboembolic complications. RESULTS: Two hundred three (35.7%) patients were classified as having a low, 186 (32.7%) moderate and 180 (31.6%) high clinical probability. Overall, DVT was diagnosed in 153 patients (26%; CI95%, 23.2-30.7%): 144 (96%) at the initial CUS, 6 (3.5%) at the second testing and 3 over the 3-month follow-up period. 22 patients had a low pretest probability (11%; CI95%, 7-16%), 43 (23%; CI95%, 17-30%) moderate, and 88 (49%; CI95%, 41-56%) high pretest probability. The difference in the prevalence of DVP among risk categories was significant (p < 0.00001). When the high and moderate groups were joined, the model had a 86% sensitivity, a 90% negative predictive value and a 43% specificity for diagnosis of DVT. CONCLUSIONS: The clinical model used in this study is accurate and feasible, though it is not enough to take clinical decisions. The diagnostic strategic used is effective but not efficient.

Trombosis venosa profunda en miembros inferiores en un servicio de urgencias. Utilidad de un modelo clínico de estratificación de riesgo / Deep venous thrombosis of lower extremities in an emergency department. Utility of a clinical diagnosis model

FUNDAMENTO: La trombosis venosa profunda (TVP) es un proceso de difícil diagnóstico. Se pretende evaluar la utilidad y efectividad diagnóstica de un cuestionario de estratificación de riesgo clínico y de una estrategia diagnóstica aplicadas a pacientes con sospecha de TVP en miembros inferiores (MMII) en un servicio de urgencias. PACIENTES Y MÉTODO: Estudio prospectivo de 569 pacientes que acudieron al servicio de urgencias con sospecha de TVP en MMII durante 14 meses. Se les aplicó un cuestionario que estratifica en grupos de probabilidad pretest (alta, moderada o baja) según síntomas-signos, factores de riesgo y diagnósticos alternativos. Se diagnosticó TVP mediante una estrategia que combina el modelo de estratificación con eco-Doppler inicial y repetición del eco-Doppler a los pacientes de riesgo medio-alto y primer eco-Doppler negativo, con seguimiento clínico (tres meses).RESULTADOS: La probabilidad clínica era baja en 203 pacientes (35,7 por ciento), media en 186 (32,7 por ciento) y alta en 180 (31,6 por ciento). Se diagnosticó TVP a 153 pacientes (26,9 por ciento), al 96 por ciento con el primer eco-Doppler, 3,5 por ciento con el segundo y 0,7 por ciento por seguimiento clínico. Presentaban bajo riesgo 22 pacientes (11 por ciento; intervalo de confianza [IC] del 95 por ciento, 7-16 por ciento); en 43 (23 por ciento; IC del 95 por ciento, 17-30 por ciento) el riesgo era medio y en 88 (49 por ciento; IC del 95 por ciento, 41-56 por ciento), alto. La diferencia de prevalencia de TVP entre categorías fue significativa (p < 0,00001). Comparando los grupos de riesgo alto y medio con el de bajo riesgo, el modelo tiene una sensibilidad del 86 por ciento, un valor predictivo negativo del 90 por ciento y una especificidad del 43 por ciento. CONCLUSIONES: El modelo de estratificación clínico utilizado es válido, útil y sencillo, aunque insuficiente como única herramienta para tomar decisiones. La estrategia diagnóstica utilizada es efectiva, pero poco eficiente (AU)