Clinical and demographic characterization of the population with osteoporosis in two reference medical centres in Colombia / Caracterización clínica y demográfica de la población con osteoporosis en 2 centros médicos de referencia en Colombia

ABSTRACT Introduction: Osteoporosis is a public health problem. However, there is still a lack of data in Colombia on the characteristics of patients with osteoporosis. Objectives: This study aims to characterize the population with osteoporosis without previous diagnosis. Materials and methods: Observational, retrospective, descriptive study in patients with osteoporosis. Patients diagnosed between 2014 and 2017 were included. The information was obtained from the patient medical records and the densitometry results. Results: Most (92.2%) of the patients came from Medellín, and the rest from Cali. The mean age of the population was 65.1 years (SD: 9.97). As regards the history of fracture, it was reported that 12.0% had suffered from vertebral fractures, 2.3% had a history of fracture in the distal radius, 2.8% in the femoral neck, and 1.4% had had femoral shaft fracture. Bone densitometry showed a mean T-score of -2.90 in the femoral neck; -3.02 in total hip; -3.03 in the lumbar spine, and -3.42 in the 33% radius. In the 602 patients who had a control bone densitometry, an average BMD gain was seen in all the evaluated regions. Conclusions: The present study has enabled the characterizing of patients from 2 Colombian cities with a diagnosis of osteoporosis. The 2 most frequently reported locations for the diagnosis of osteoporosis were lumbar spine and femoral neck. An average BMD gain was also observed.

RESUMEN Introducción: La osteoporosis es un problema de salud pública, sin embargo, en Colombia en la actualidad faltan datos sobre las características de los pacientes con esta enfermedad. Objetivos: Este estudio pretende caracterizar la población con osteoporosis sin diagnóstico previo. Materiales y métodos: Estudio observacional, retrospectivo, descriptivo en pacientes con osteoporosis. Incluyó a pacientes diagnosticados entre el 2014 y el 2017. La información fue obtenida a partir de las historias clínicas de los pacientes y el resultado de la densitometría. Resultados: El 92,2% de los pacientes provenía de Medellín y los restantes de Cali. La edad promedio ± desviación estándar de la población fue 65,1 ± 9,97 arios. En cuanto al antecedente de fractura, se reportó que el 12,0% había presentado fracturas vertebrales, el 2,3% tenía antecedente de fractura en radio distal, el 2,8% en cuello femoral y el 1,4% había tenido fractura de diáfisis femoral. La densitometría ósea (DMO) mostró un T-score promedio de -2,90 en cuello femoral, -3,02 en cadera total, -3,03 en columna lumbar y-3,42 en radio 33%. En los 602 pacientes que contaban con DMO de control se vio una ganancia de la DMO promedio en todas las regiones evaluadas. Conclusiones: El presente estudio permitió caracterizar a pacientes con diagnóstico de osteoporosis en 2 ciudades de Colombia. Las 2 localizaciones más reportadas para el diagnóstico de osteoporosis fueron columna lumbar y cuello femoral; adicionalmente, se observó una ganancia de la DMO promedio.

Incremental Learning in Modelling Process Analysis Technology (PAT)-An Important Tool in the Measuring and Control Circuit on the Way to the Smart Factory.

To meet the demands of the chemical and pharmaceutical process industry for a combination of high measurement accuracy, product selectivity, and low cost of ownership, the existing measurement and evaluation methods have to be further developed. This paper demonstrates the attempt to combine future Raman photometers with promising evaluation methods. As part of the investigations presented here, a new and easy-to-use evaluation method based on a self-learning algorithm is presented. This method can be applied to various measurement methods and is carried out here using an example of a Raman spectrometer system and an alcohol-water mixture as demonstration fluid. The spectra's chosen bands can be later transformed to low priced and even more robust Raman photometers. The evaluation method gives more precise results than the evaluation through classical methods like one primarily used in the software package Unscrambler. This technique increases the accuracy of detection and proves the concept of Raman process monitoring for determining concentrations. In the example of alcohol/water, the computation time is less, and it can be applied to continuous column monitoring.

Baseline characteristics of postmenopausal women with osteoporosis treated with teriparatide in a real-world setting in Latin America: a subregional analysis from the Asia and Latin America Fracture Observational Study (ALAFOS).

BACKGROUND: Osteoporosis is a major healthcare concern in Latin America. Factors such as changing demographics, fragmented healthcare systems, and financial considerations may result in a huge increase in the burden of osteoporosis in this region. The aim of this article is to describe the baseline clinical characteristics and fracture history of patients who are prescribed teriparatide in normal clinical practice in Latin America. METHODS: We conducted a prospective, multinational, observational study (the Asia and Latin America Fracture Observational Study [ALAFOS]) in 20 countries worldwide to assess the incidence of fractures in postmenopausal women with osteoporosis receiving teriparatide as a part of routine clinical practice in a real-world setting. In this subregional analysis of the ALAFOS study, we report the clinical characteristics, fracture history, risk factors for osteoporosis, comorbidities, previous osteoporosis therapies and health-related quality of life measures at baseline for patients from the four participant Latin American countries: Argentina, Brazil, Colombia, and Mexico. RESULTS: The Latin America subregional cohort included 546 postmenopausal women (mean [SD] age: 71.0 [10.1] years; range: 40-94 years), constituting 18% of the ALAFOS total population. The baseline mean (SD) bone mineral density T-scores were - 3.02 (1.23) at the lumbar spine and - 2.31 (0.96) at the femoral neck; 62.8% of patients had a history of low trauma fracture after the age of 40 years and 39.7% of patients had experienced ≥1 fall in the past year. Osteoporosis medications were used by 70.9% of patients before initiating teriparatide. The median (Q1, Q3) EQ-5D-5 L Visual Analog Scale (VAS) scores for perceived health status at baseline was 70 (50, 80). The mean (SD) worst back pain numeric rating scale score for the overall Latin American cohort was 4.3 (3.4) at baseline. CONCLUSIONS: This baseline analysis of the Latin America subregion of the ALAFOS study indicates that patients who are prescribed teriparatide in the four participant countries had severe osteoporosis and high prevalence of fractures. They also had back pain and poor health-related quality of life. The proportions of patients with severe or extreme problems on the EQ-5D-5 L individual domains were lower than those in the overall ALAFOS study population.

Baseline characteristics of postmenopausal women with osteoporosis treated with teriparatide in a real-world setting in Latin America: a subregional analysis from the Asia and Latin America Fracture Observational Study (ALAFOS)

Abstract Background: Osteoporosis is a major healthcare concern in Latin America. Factors such as changing demographics, fragmented healthcare systems, and financial considerations may result in a huge increase in the burden of osteoporosis in this region. The aim of this article is to describe the baseline clinical characteristics and fracture history of patients who are prescribed teriparatide in normal clinical practice in Latin America. Methods: We conducted a prospective, multinational, observational study (the Asia and Latin America Fracture Observational Study [ALAFOS]) in 20 countries worldwide to assess the incidence of fractures in postmenopausal women with osteoporosis receiving teriparatide as a part of routine clinical practice in a real-world setting. In this subregional analysis of the ALAFOS study, we report the clinical characteristics, fracture history, risk factors for osteoporosis, comorbidities, previous osteoporosis therapies and health-related quality of life measures at baseline for patients from the four participant Latin American countries: Argentina, Brazil, Colombia, and Mexico. Results: The Latin America subregional cohort included 546 postmenopausal women (mean [SD] age: 71.0 [10.1] years; range: 40-94 years), constituting 18% of the ALAFOS total population. The baseline mean (SD) bone mineral density T-scores were - 3.02 (1.23) at the lumbar spine and - 2.31 (0.96) at the femoral neck; 62.8% of patients had a history of low trauma fracture after the age of 40 years and 39.7% of patients had experienced ≥1 fall in the past year. Osteoporosis medications were used by 70.9% of patients before initiating teriparatide. The median (Q1, Q3) EQ-5D-5 L Visual Analog Scale (VAS) scores for perceived health status at baseline was 70 (50, 80). The mean (SD) worst back pain numeric rating scale score for the overall Latin American cohort was 4.3 (3.4) at baseline. Conclusions: This baseline analysis of the Latin America subregion of the ALAFOS study indicates that patients who are prescribed teriparatide in the four participant countries had severe osteoporosis and high prevalence of fractures. They also had back pain and poor health-related quality of life. The proportions of patients with severe or extreme problems on the EQ-5D-5 L individual domains were lower than those in the overall ALAFOS study population.

First Latin American clinical practice guidelines for the treatment of systemic lupus erythematosus: Latin American Group for the Study of Lupus (GLADEL, Grupo Latino Americano de Estudio del Lupus)-Pan-American League of Associations of Rheumatology (PANLAR).

Systemic lupus erythematosus (SLE), a complex and heterogeneous autoimmune disease, represents a significant challenge for both diagnosis and treatment. Patients with SLE in Latin America face special problems that should be considered when therapeutic guidelines are developed. The objective of the study is to develop clinical practice guidelines for Latin American patients with lupus. Two independent teams (rheumatologists with experience in lupus management and methodologists) had an initial meeting in Panama City, Panama, in April 2016. They selected a list of questions for the clinical problems most commonly seen in Latin American patients with SLE. These were addressed with the best available evidence and summarised in a standardised format following the Grading of Recommendations Assessment, Development and Evaluation approach. All preliminary findings were discussed in a second face-to-face meeting in Washington, DC, in November 2016. As a result, nine organ/system sections are presented with the main findings; an 'overarching' treatment approach was added. Special emphasis was made on regional implementation issues. Best pharmacologic options were examined for musculoskeletal, mucocutaneous, kidney, cardiac, pulmonary, neuropsychiatric, haematological manifestations and the antiphospholipid syndrome. The roles of main therapeutic options (ie, glucocorticoids, antimalarials, immunosuppressant agents, therapeutic plasma exchange, belimumab, rituximab, abatacept, low-dose aspirin and anticoagulants) were summarised in each section. In all cases, benefits and harms, certainty of the evidence, values and preferences, feasibility, acceptability and equity issues were considered to produce a recommendation with special focus on ethnic and socioeconomic aspects. Guidelines for Latin American patients with lupus have been developed and could be used in similar settings.

Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial.

BACKGROUND: Previous bisphosphonate treatment attenuates the bone-forming effect of teriparatide. We compared the effects of 12 months of romosozumab (AMG 785), a sclerostin monoclonal antibody, versus teriparatide on bone mineral density (BMD) in women with postmenopausal osteoporosis transitioning from bisphosphonate therapy. METHODS: This randomised, phase 3, open-label, active-controlled study was done at 46 sites in North America, Latin America, and Europe. We enrolled women (aged ≥55 to ≤90 years) with postmenopausal osteoporosis who had taken an oral bisphosphonate for at least 3 years before screening and alendronate the year before screening; an areal BMD T score of -2·5 or lower at the total hip, femoral neck, or lumbar spine; and a history of fracture. Patients were randomly assigned (1:1) via an interactive voice response system to receive subcutaneous romosozumab (210 mg once monthly) or subcutaneous teriparatide (20 µg once daily). The primary endpoint was percentage change from baseline in areal BMD by dual-energy x-ray absorptiometry at the total hip through month 12 (mean of months 6 and 12), which used a linear mixed effects model for repeated measures and represented the mean treatment effect at months 6 and 12. All randomised patients with a baseline measurement and at least one post-baseline measurement were included in the efficacy analysis. This trial is registered with ClinicalTrials.gov, number NCT01796301. FINDINGS: Between Jan 31, 2013, and April 29, 2014, 436 patients were randomly assigned to romosozumab (n=218) or teriparatide (n=218). 206 patients in the romosozumab group and 209 in the teriparatide group were included in the primary efficacy analysis. Through 12 months, the mean percentage change from baseline in total hip areal BMD was 2·6% (95% CI 2·2 to 3·0) in the romosozumab group and -0·6% (-1·0 to -0·2) in the teriparatide group; difference 3·2% (95% CI 2·7 to 3·8; p<0·0001). The frequency of adverse events was generally balanced between treatment groups. The most frequently reported adverse events were nasopharyngitis (28 [13%] of 218 in the romosozumab group vs 22 [10%] of 214 in the teriparatide group), hypercalcaemia (two [<1%] vs 22 [10%]), and arthralgia (22 [10%] vs 13 [6%]). Serious adverse events were reported in 17 (8%) patients on romosozumab and in 23 (11%) on teriparatide; none were judged treatment related. There were six (3%) patients in the romosozumab group compared with 12 (6%) in the teriparatide group with adverse events leading to investigational product withdrawal. INTERPRETATION: Transition to a bone-forming agent is common practice in patients treated with bisphosphonates, such as those who fracture while on therapy. In such patients, romosozumab led to gains in hip BMD that were not observed with teriparatide. These data could inform clinical decisions for patients at high risk of fracture. FUNDING: Amgen, Astellas, and UCB Pharma.

Treatment of Rheumatoid Arthritis With Anti-Tumor Necrosis Factor or Tocilizumab Therapy as First Biologic Agent in a Global Comparative Observational Study.

OBJECTIVE: To compare clinical effectiveness between tocilizumab and tumor necrosis factor inhibitors (TNFi) in patients with rheumatoid arthritis (RA) and inadequate response to conventional synthetic disease-modifying antirheumatic drugs initiating biologic therapy. METHODS: Patients prescribed tocilizumab (intravenous) or TNFi were prospectively observed in routine clinical practice for 52 weeks across 158 sites in 26 countries. The primary observation was the change from baseline in Disease Activity Score based on 28 joints using the erythrocyte sedimentation rate (DAS28-ESR) at week 24 using analysis of covariance for between-groups comparison. Secondary end points included Clinical Disease Activity Index (CDAI) and patient-reported outcomes at weeks 24 and 52. RESULTS: Of 1,216 patients, 35% initiated tocilizumab and 65% initiated TNFi. RA duration was shorter, and disease activity and corticosteroid use were higher in tocilizumab patients. Tocilizumab-treated patients had greater improvement in DAS28-ESR at weeks 24 and 52 (week 24 difference [95% confidence interval] in adjusted means: -0.831 [-1.086, -0.576]; P < 0.001). Change from baseline in CDAI was also greater with tocilizumab (adjusted means difference: week 24, -3.48; week 52, -4.60; both P < 0.001). Tocilizumab-treated patients had more improvement in the Health Assessment Questionnaire disability index than TNFi-treated patients (P < 0.05). The cumulative probability of drug discontinuation at week 52 was lower with tocilizumab (15%) than TNFi (27%; P < 0.001, unadjusted analysis). Unadjusted frequencies (events per 100 patient-years) for tocilizumab and TNFi were 6.44 and 11.99 for serious adverse events, 1.98 and 5.03 for serious infections, and 0.74 and 0.77 for deaths, respectively. CONCLUSION: Patients initiating tocilizumab experienced greater effectiveness and drug survival than those initiating TNFi in an observational setting.

Factors predictive of high disease activity early in the course of SLE in patients from a Latin-American cohort.

AIMS: To determine the factors predictive of disease activity early in the course of SLE (baseline visit). METHODS: Patients from GLADEL, a multi-national, multi-ethnic, Latin-American lupus cohort were included. Disease activity was evaluated at baseline with the SLEDAI score. Demographic characteristics (age at diagnosis, gender, ethnicity, marital status, educational level, medical coverage and socioeconomic status) were assessed. Disease duration was defined as the time between the fourth ACR criterion and baseline. Time to criteria accrual was defined as the interval between the first and fourth ACR criterion. Use of glucocorticoids was recorded as the highest dose received before the baseline visit. Antimalarials and immunosuppressive drugs were recorded as use or not use. Univariable and multivariable analysis were performed. Model selection was based on backward elimination. RESULTS: One thousand two hundred sixty-eight patients were included; 1136 (89.6%) of them were female. Mean age at diagnosis was 29.2 (SD: 12.3) years. Five hundred sixty-five (44.6%) were Mestizo, 539 (42.5%) were Caucasians and 164 (12.9%) were African-Latin-Americans. The mean SLEDAI at baseline was 10.9 (SD: 8.4). Longer time between first and fourth ACR criterion, medical coverage, a dose of prednisone between 15 and 60mg/d, and the use of antimalarials were factors protective of disease activity, while Mestizo and African-Latin-American ethnicities were predictive factors. CONCLUSIONS: Mestizo and African-Latin-American ethnicities were predictive whereas antimalarial use, medical coverage, and longer time to criteria accrual were protective of higher disease activity early in the disease course.

Incremental learning with SVM for multimodal classification of prostatic adenocarcinoma.

Robust detection of prostatic cancer is a challenge due to the multitude of variants and their representation in MR images. We propose a pattern recognition system with an incremental learning ensemble algorithm using support vector machines (SVM) tackling this problem employing multimodal MR images and a texture-based information strategy. The proposed system integrates anatomic, texture, and functional features. The data set was preprocessed using B-Spline interpolation, bias field correction and intensity standardization. First- and second-order angular independent statistical approaches and rotation invariant local phase quantization (RI-LPQ) were utilized to quantify texture information. An incremental learning ensemble SVM was implemented to suit working conditions in medical applications and to improve effectiveness and robustness of the system. The probability estimation of cancer structures was calculated using SVM and the corresponding optimization was carried out with a heuristic method together with a 3-fold cross-validation methodology. We achieved an average sensitivity of 0.844 ± 0.068 and a specificity of 0.780 ± 0.038, which yielded superior or similar performance to current state of the art using a total database of only 41 slices from twelve patients with histological confirmed information, including cancerous, unhealthy non-cancerous and healthy prostate tissue. Our results show the feasibility of an ensemble SVM being able to learn additional information from new data while preserving previously acquired knowledge and preventing unlearning. The use of texture descriptors provides more salient discriminative patterns than the functional information used. Furthermore, the system improves selection of information, efficiency and robustness of the classification. The generated probability map enables radiologists to have a lower variability in diagnosis, decrease false negative rates and reduce the time to recognize and delineate structures in the prostate.

Costos de fracturas en mujeres con osteoporosis en Colombia / Costs of fractures in women with osteoporosis in Colombia

Resumen Introducción: la osteoporosis posmenopáusica (OPM) es una enfermedad que reduce la densidad yla calidad de los huesos, aumentando el riesgo de sufrir fracturas. En Colombia no existe información documentada sobre los costos, ni las frecuencias de uso de recursos para el diagnóstico y tratamiento de la OPM y las fracturas asociadas. Material y métodos: se realizó un consenso con 11 expertos, mediante una metodología Delphi modificada, se aplicaron los costos utilizando el manual tarifario ISS 2001, finalmente, se estimó para 2015 qué impacto económico tendría para el país el tratamiento de las fracturas de cadera, vertebrales y de radio distal. Resultados: el costo de diagnosticar y seguir adecuadamente a una paciente con OPM por un año, es de aproximadamente $622.588,15; el costo en el momento de presentarse una fractura de cadera que requiera manejo quirúrgico, es $8.687.829,21, el costo de manejar quirúrgicamente una fractura vertebral y de radio distal es $11.348.379,90 y $2.319.111,67 respectivamente. Los pacientes con fractura vertebral que no requieren manejo quirúrgico pueden costar $5.034.055,60 en un año de seguimiento. Para el 2015 el impacto económico de tratar las fracturas de cadera en el país sería de $205.602.914.414, para las vertebrales con manejo quirúrgico sería de $1.370.947.862, y con manejo no quirúrgico sería de $11.653.771.426 y para las fracturas de radio distal sería de $122.858.360.231. Conclusiones: Se hace evidente la necesidad de priorizar la enfermedad, gestionar los riesgos asociados a sus complicaciones y darle el manejo de una patología de alto impacto en la salud pública. (Acta Med Colomb 2014; 39: 46-56).

Abstract Introduction: postmenopausal osteoporosis (PMO) is a disease that reduces the density and quality of bones, increasing the risk of fractures. In Colombia there is no documented information on the costs and frequency of use of resources for the diagnosis and treatment of OPM and associated fractures. Materials and methods: a consensus with 11 experts was conducted using a Delphi modified methodology. Costs were applied using the tariff handbook ISS 2001 and in the end was estimated what economic impact would have in 2015 for the country the treatment of hip vertebral and distal radius fractures. Results: the cost to diagnose and properly follow a patient with PMO for one year is approximately $622,588.15. The cost at the time of a hip fracture that requires surgical management is $8,687,829.21. The cost of surgical management of a spinal fracture and distal radius is $11,348,379.90 and $2,319,111.67 respectively. Patients with spinal fractures that do not require surgical management can cost $5,034,055.60 in a one year follow up. By 2015, the economic impact of treating hip fractures in the country would be $205,602,914,414, for vertebral fractures with surgical management would be $1,370,947,862, and non-surgical management would be $11,653,771,426 and for distal radius fractures it would be $122,858,360,231. Conclusions: the need to prioritize the disease, manage the risks associated with its complications and offer the management of a pathology of high impact on public health, is evident. (Acta Med Colomb 2014; 39: 46-56).

Niveles de 25 hidroxivitamina D y su correlación clínica con diferentes variables metabólicas y cardiovasculares en una población de mujeres posmenopáusicas / Levels of 25-hydroxyvitamin D and their clinical correlation with several metabolic and cardiovascular variables in a population of postmenopausal women

Introducción: la osteoporosis es la enfermedad ósea metabólica más común. Entre sus causas secundarias se encuentra la deficiencia de vitamina D (VD), la cual predispone además a fracturas por fragilidad e incrementa el riesgo de caídas. También confiere un riesgo incrementado de desarrollar enfermedad cardiovascular, diabetes mellitus tipo 1 y 2. Objetivo: el objetivo principal del estudio fue determinar los niveles de vitamina D en la población y correlacionarlos con diferentes variables clínicas, de laboratorio y densitométricas. Métodos: se realizó un estudio descriptivo de corte transversal, de una cohorte de pacientes donde se analizaron datos secundarios de mujeres posmenopáusicas colombianas con diagnóstico de osteoporosis y osteopenia (N=205). Se analizaron 46 variables donde se calcularon estadísticos descriptivos y regresiones lineales múltiples para determinar correlaciones. Resultados: la prevalencia de niveles insuficientes de vitamina D fue 55.1%, (n=113), deficientes 16.6% (n=34), y adecuados sólo 28.29% (n=58). Al comparar los pacientes con niveles deficientes e insuficientes, se encontró que los pacientes con niveles de vitamina D deficientes fue un factor de riesgo para la presencia de fracturas vertebrales, RR de 1.02 (IC: 0.96 a 1.06) y para la hipertensión arterial RR de 1.47 (IC: 1.36 a 1.58). Conclusión: dos terceras partes de nuestra población de pacientes tienen niveles inadecuados de vitamina D, y se encontró correlación con fracturas vertebrales e hipertensión arterial (Acta Med Colomb 2011; 36: 18-23).

Introduction: osteoporosis is the most common metabolic bone disease. Vitamin D deficiency is an important cause of secondary osteopenia and osteoporosis. It predisposes to fragility fractures and increases the risk of falling, while augmenting the risk of developing cardiovascular disease and diabetes mellitus type 1 and 2. Objective: the objective of this study was to determine the levels of vitamin D in our population study and to correlate them with bone density, vertebral fractures, and other cardiovascular and laboratory variables. Methods: we conducted a cross-sectional study of a cohort (n=205) of postmenopausal Colombian women diagnosed with osteoporosis and osteopenia. We analyzed 46 variables. Descriptive statistics were used, and multiple linear regressions were analyzed in order to determine correlations. Results: it was found that the prevalence of insufficient levels of vitamin D was 55.1% (n=113), deficient levels 16.6% (n=34), and adequate levels in only 28.29% (n=58) of patients. Comparing poor and inadequate levels, we found that deficient levels of vitamin D are a risk factor for vertebral fractures, with an RR of 1.02 (IC: 0,96 a 1.06) and for high blood pressure. with an RR of 1.47 (IC: 1.36 a 1.58). Conclusions: our study shows that inadequate levels of vitamin D are common in our population. This is associated with low bone mass, vertebral fractures, and hypertension. Further studies are needed in our country to confirm our findings (Acta Med Colomb 2011; 36: 18-23).

Actualidad en el tratamiento de la nefritis lúpica proliferativa / Update on the treatment of proliferative lupus nephritis

La nefropatía lúpica (NL) es una causa importante de morbilidad y mortalidad en pacientes con lupus eritematoso sistémico (LES) la cual tiene un impacto directo en la supervivencia de estos pacientes. El uso de un tratamiento inmunosupresor agresivo ha mejorado la supervivencia renal y de los pacientes. Los objetivos de esta terapia inmunosupresora son la obtención de una remisión temprana, evitar la aparición de exacerbaciones y la progresión a insuficiencia renal crónica con la mínima toxicidad posible. El tratamiento con pulsos intravenosos mensuales de ciclofosfamida y de glucocorticoides (el régimen del Instituto Nacional de Salud) como tratamiento de inducción y la administración a largo plazo de pulsos venosos de ciclofosfamida o con azatioprina ha llegado a ser el tratamiento estándar de la NL proliferativa severa. El micofenolato mofetil es una alternativa a la ciclofosfamida en el tratamiento de inducción y de mantenimiento de la NL proliferativa. Existen otras opciones terapéuticas para la NL resistente como regímenes más agresivos de ciclofosfamida (a expensas de una mayor toxicidad), inhibidores de la calcineurina, gamaglobulina hiperinmune intravenosa, inmunoadsorción y terapias dirigidas contra la célula B.

Lupus nephritis (LN) is an important cause of morbidity and mortality in patients with systemic lupus erythematosus (SLE). The use of aggressive immunosuppressive treatment has improved both patient and renal survival. The objectives of this therapy should be to achieve a prompt renal remission, to avoid renal flares and progression to chronic renal failure with minimal toxicity. Treatment with monthly intravenous cyclophosphamide and glucocorticoids (National Institute of Health regimen) as induction treatment and long-term administration of venous pulses of cyclophosphamide or azathioprine has become standard treatment for severe proliferative LN. Mycophenolate mofetil is an alternative to cyclophosphamide for induction and maintenance therapy of proliferative LN. There are other therapeutic options for resistant LN as more aggressive ciclophosphamide regimens, but at the expense of more toxicity, calcineurin inhibitors, intravenous immunoglobulin, immunoadsorption and therapies that selectively target B cells.

Epidemiología de la osteoporosis / Epidemiology of osteoporosis

La osteoporosis se define como una entidad esquelética caracterizada por baja masa ósea y deterioro de la microarquitectura ósea, lo cual lleva a una mayor fragilidad ósea y riesgo de fractura. Todas las fracturas osteoporóticas aumentan la morbilidad de los pacientes; sin embargo, las fracturas de cadera y vertebrales también están asociadas con una mayor mortalidad. Estas fracturas por fragilidad también son una carga considerable para el sistema de salud y tienen un gran impacto económico. Por lo tanto, el conocimiento de la epidemiología de la enfermedad es fundamental para tratar de desarrollar estrategias que estén orientadas a disminuir esta carga.

Osteoporosis is defined as a systemic skeletal disorder characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. All osteoporotic fractures increase patient morbidity; however, fractures of the hip and vertebrae are also associated with important mortality. These fragility fractures have a considerable burden to health care system and a huge economic impact. Understanding the epidemiology of this disease is therefore necessary in trying to develop strategies to help reduce this load.

Estudio multicéntrico para evaluar la efectividad y seguridad de una presentación de alendronato de sodio en cápsulas de gelatina blanda (Neobon 70 ®), en el tratamiento de osteoporosis posmenopáusica / Multicentre study to evaluate the effectiveness and security of sodium alendronate in a soft gelatin capsules in the treatment of postmenopausal osteoporosis

Objetivos: el objetivo del estudio fue evaluar la respuesta al tratamiento y seguridad del alendronato de sodio en una presentación de cápsulas blandas de gelatina (Neobon 70 ®), en mujeres posmenopáusicas con osteoporosis u osteopenia. Métodos: estudio clínico multicéntrico abierto a un año de tratamiento en mujeres postmenopáusicas. Las pacientes fueron asignadas a recibir 70 mg cada semana de alendronato sódico en presentación de cápsulas de gelatina blanda. Los desenlaces primarios fueron la densidad mineral ósea medida por DEXA y el valor plasmático del C-Telopéptido. La condición ósea fue evaluada por densitometría al inicio del estudio, al mes 6 y a los 12 meses de tratamiento. La resorción ósea fue evaluada por los niveles de C-Telopéptido basal, a los 3, 6 y 12 meses de tratamiento. Como desenlace secundario se evaluó la presentación de eventos adversos secundarios. Resultados: el estudio incluyó 146 mujeres reclutadas en diez centros de consulta externa de reumatología en cuatro ciudades de Colombia, que tuvieran diagnóstico de osteoporosis u osteopenia. La media de edad fue de 67±8 años (rango entre 45,7 y 92,8 años), y el promedio de tiempo transcurrido desde el inicio de la menopausia fue de 16±7,8 años. Treinta pacientes (20,54%) tenían una historia de fracturas previas. Al mes 12 de tratamiento se observó una reducción clínica y estadísticamente significativa en el nivel del C-Telopéptido (basal 0,53, tercer mes 0,22, sexto mes 0,17 y al año 0,17, p < 0,00001). Adicionalmente, se observó una mejoría estadísticamente significativa con el tratamiento en los valores del T-score a nivel de vértebras lumbares L2-L4 (basal -2,57, al sexto mes -2,27 y -2,29 al año), en el cuello de fémur (basal -2,37, al sexto mes -1,98 y al año -1,99), en el trocánter (basal -1,95, al sexto mes -1,55, y al año -1,41) y en la cadera (basal -1,73, al sexto mes -1,6 y -1,57 al año). También se observó mejoría en los parámetros de densidad mineral ósea, con un incremento de 2,3% a nivel vertebral lumbar y 2,59% en cadera. No hubo cambios en la densidad mineral ósea a nivel de cuello de fémur y trocánter. Estos cambios son similares a los observados con otras presentaciones de alendronatos y bifosfonatos. Como eventos adversos relacionados, solo se observó en el 8,2% la presencia de síntomas dispépticos, vértigo en el 3,4%, cefalea en el 2,7% y estreñimiento en el 1,4%. Conclusiones: estos resultados muestran que la presentación de alendronato sódico en cápsulas de gelatina blanda produce una gran mejoría en los parámetros evaluados por la densitometría y en el C-Telopéptido en mujeres posmenopáusicas con osteoporosis u osteopenia, y es una presentación farmacológica segura en mujeres jóvenes y de mayor edad.

Objectives: the purpose of this study was to evaluate the response to treatment and safety of Sodium Alendronate in a soft gelatin capsules presentation (Neobon 70 ®), in a postmenopausal women with osteoporosis or osteopenia. Methods: open multicenter clinical trial during one year was conducted in postmenopausal women. The patients were assigned to receive 70 mg of Sodic Alendronate in a soft gelatin capsule presentation, once time per week. The primaries endpoints were the bone density mineral measured by DEXA and the C-telopeptide serum level. The bone condition was evaluated by basal bone densitometry, 6 and 12 months. The bone resortion was evaluated by basal C-telopeptide serum levels, to 3, 6 and 12 months. The secondary endpoint was the presentation of secondary adverse events. Results: the study included 146 patients recruited in 10 rheumatologic clinical centers in Colombia, with diagnosis of osteopenia or osteporosis. Mean aged was 67±8 years (range 45.7 to 92.8 years) and the mean duration of menopausal time was 16±7.8 years. Thirty patients (20.54%) had a history of previous fracture bone. At month 12, a statistically significant reduction from base line in mean of C-telopeptide serum level was observed (basal 0.53, 3 month 0.22, 6 month 0.17 and 12 month 0.17, p < 0.00001). In addition, there was a clinical and statistically significant improvement in the T-score with the treatment in lumbar vertebrae L2-L4 (basal -2.57, 6 month -2.27 and 12 month -2.29), femur (basal -2.37, 6 month -1.98 and 12 month -1.99), trochanter (basal -1.95, 6 month -1.55 and 12 month -1.41), and in hip (basal -1.73, 6 month -1.6 and 12 month -1.57). Also it was observed an improvement in the parameters of bone density of 2.3% at lumbar vertebral level and of 2.59% in hip. No significant changes were observed in a left neck femur and trochanter. These increases are similar to observed with other presentations of alendronates and biphosphonates. Among this population, only the 8.2% had dyspeptic symptoms, 3.4% vertigo, 2.7% cephalea and 1.4% constipation. Conclusion: these findings showed that the presentation of sodium Alendronate in soft gelatin capsules produced a greater improvement in bone markers and densitometry scores in postmenopausal women with osteoporosis and osteopenia and is a safety pharmacological presentation in young and older patients.

Nuevos avances de la terapia biológica en la psoriasis / New advances in biologic therapy of psoriasis

La psoriasis es considerada una enfermedad inflamatoria crónica, multifactorial, que afecta el 1 al 3 % de la población mundial, se caracteriza por la proliferación de queratinocitos, causada por la estimulación persistente de células T por inmunógenos de origen epidérmico. Existen múltiples tratamientos como son la terapia tópica y sistémica, con resultados variables; actualmente se ha venido desarrollando nuevas terapias dirigidas contra moléculas de adhesión, contra la activación y la migración de los linfocitos T y sus productos como citocinas, las cuales juegan un papel clave en la patogénesis de esta entidad. La Food Drug Administration (FDA) ha aprobado el Alefacept, anticuerpo monoclonal dirigido contra el CD2, el Efalizumab, anticuerpo monoclonal que bloquea la interacción del Antigeno de Función Leucocitaria 1 (LFA-l) con la Molécula de Adhesión Intercelular 1 (ICAM-1) y el Etanercept, proteína de fusión del receptor del Factor de Necrosis Tumoral a soluble, para ser usados en psoriasis y artritis psoriática. Aunque estas terapias son prometedoras, sólo el seguimiento a largo plazo podrá evaluar los posibles efectos adversos y las nuevas indicaciones para el uso de estos medicamentos. Actualmente están siendo estudiadas otras terapias biológicas para ser usadas en psoriasis como el lnfliximab, anticuerpo monoclonal que interfiere con la acción del FNTalpha

Psoriasis is a common, multifactorial, chronic inflammatory disease that affects 1-3% of the world population. It is characterized by abnormal proliferation of keratinocytes due to a persistent stimulation of T cells by epidermic immunogens. There are multiple treatments such as topic and systemic therapy with variable results. Recently new therapies directed against adhesion molecules, activation and migration of T Iymphocytes, and their products like cytokines, have been developed and play an important role in the pathogenesis of this disease. The Food Orug Administration (FOA) has approved Alefacept, an antibody directed against C02, Efalizumab, a monoclonal antibody that block the interaction between Leucocitary Funtion Antigen 1 (LFA -1) to Interercellular Adhesion Molecule 1 (lCAM -1) and Etanercept, a Tumoral Necrosis Factor a (TNFalpha) receptor fusion protein, for the use in psoriasis and psoriatic arthritis. Even though they appear to be promising medications, close attention needs to be directed to their safety and development of long term side effects and new indications of these medications. Actually other biologic therapies have been study for the use in psoriasis like Infliximab, monoclonal antibody that blocks the action of TNFalpha

Enfermedad de BehÇet: espectro clínico de ocho pacientes en la ciudad de Medellín / BehÇet's disease: clinical findings in eight patients from Medellín, Colombia

El presente estudio, primero en nuestro medio, nos ha permitido conocer más sobre los aspectos clínicos de la enfermedad de Behçet sugiriendo además que existen pocas diferencias en comparación con otras series del mundo.

Glucosamina: Cual es la evidencia? / Glucosamine: which is the evidence?

La osteoartritis es una enfermedad que afecta a la gran mayoria de los individuos mayores de 60 años. A pesar de los recientes avances en la etiopatogenesis y en el manejo de dicha entidad aun no contamos con tratamientos efectivos que al mismo tiempo mejoren los sintomas y detengan la evolucion de la enfermedad. Desde hace algunos años se ha venido promulgando el uso de suplementos nutricionales como parte del tratamiento, en especial del uso de la glucosamina. Las ventajas in vitro han sido demostradas tambien en varios estudios clinicos pero estos trabajos han dejado algunas dudas sobre la magnitud del efecto benefico. Esta revision que incluye los trabajos mas recientes a Octubre de 2000 sobre el uso de la glucosamina en la osteoartrosis y ofrece una vision objetiva sobre dicha opcion terapeutica. La decision final del uso de la glucosamina debe ser ajustada en forma individual no siendo posible extrapolar los resultados actuales a toda la poblacion con osteoartritis