Revisión del uso de los medicamentos biosimilares vs. biológicos: implicaciones para la salud en Colombia.

Este documento tiene como objetivo describir las implicaciones para la salud con el uso de medicamentos biosimilares en comparación con los medicamentos biológicos en Colombia. Así mismo, describir el contexto normativo acerca del uso de medicamentos biosimilares, las recomendaciones y lineamientos sobre seguridad y efectividad del uso de medicamentos Biosimilares y Biológicos, partiendo de sus diferencias biomoleculares. Para esto, se desarrolló una revisión documental electrónica y manual de la literatura en bases de datos, revistas y libros limitada a términos MeSH. La selección de los artículos incluyo documentos completos publicados en revistas indexadas de los últimos 10 años, en español e inglés; la información recolectada se organizó para la construcción del presente documento. Concluyendo, se encontró que las patentes de muchos medicamentos biológicos han vencido o están próximas a caducar y varios biosimilares están desarrollándose y comercializándose incluso en países sin regulaciones estrictas. Los biosimilares nunca podrán ser iguales al original por su complejidad molecular, por ello debemos integrarlos a los sistemas de farmacovigilancia mejorando trazabilidad e identificando su origen mientras se establecen denominaciones comunes distinguibles. La evidencia actual sugiere que la regulación de medicamentos biosimilares debe ser evaluada y armonizada en todo el mundo.

Estructuración de los procesos y la función de recursos humanos alineados con el direccionamiento estratégico en Kathmandu restaurante

El direccionamiento estratégico está destinado para que las organizaciones cumplan con sus metas y tengan perdurabilidad en el tiempo; es una forma metodológica en la cual se establecen La formulación y el planteamiento estratégicos, se identifican las brechas entre el sueño de la empresa y su realidad, para desplegar la plata forma estratégica. Kathmandu es un restaurante conocido por su diversidad cultural gastronómica, ubicado en Usaquén al Norte de Bogotá. Su serviespacio reúne los sabores, aromas, decoración y elixires del oriente, su música incluye una fusión de sonidos que permite materializar la experiencia que quiere brindar para satisfacer las expectativas de sus comensales y brindarles una experiencia diferente. Los fines de semana presentan shows de danza de vientre, para acompañar la comida y el rato que dispongan disfrutar en este lugar. Este restaurante tiene un diferenciador en su servicio, que le ofrece una ventaja competitiva, Kathmandu brinda la posibilidad de que además del deleite de sus platos, los clientes puedan adquirir toda la decoración de este lugar, estas son artesanías originales traídas de Nepal, India, Tailandia, Indonesia y sus alrededores. Otro atrayente de este restaurante son los cocteles alusivos a las regiones del oriente, y la narguile que ofrece a sus clientes. Al pasar de los años, ciertos inconvenientes presentados en el negocio, con los clientes, el personal y las utilidades, han hecho que los gerentes se preocupen por encontrar la raíz del problema y buscar la solución óptima para perdurar en el tiempo con los mejores beneficios posibles, pues las estrategias que estaban implementando no van acorde a su misión y visión, por lo que es necesario realizar una restructuración de ciertos procesos enfocados al direccionamiento estratégico. Se realizó un análisis en una reunión junto a las directivas sobre cada área de la organización donde se evidenciaron problemas que deben ser tratados para hacer de Kathmandu una empresa más eficiente, eficaz y productiva. Y prepararla para afrontar los cambios que el tiempo le presente, en cuanto a preferencias de los clientes, competencia, entre otras, bien sean a corto, mediano o largo plazo. Algunos de los principales problemas encontrados son: el servicio al cliente, la selección adecuada de personal y capacitación de este, la falta de manejo de un conducto jerárquico y repartición de funciones entre los colaboradores, el informe adecuado sobre la inconformidad de los clientes con su solución, el manual de funciones, el manejo de inventarios y su rotación, verificación de calidad de los productos, manejo de proveedores, entre otros. Kathmandu, a pesar de tener problemas evidentes, es una empresa que por los servicios y productos que ofrece sigue generando buenas utilidades, por esto los gerentes no le habían prestado la debida atención a estos inconvenientes que están poniendo en juego la perdurabilidad de la empresa y que afecta la optimización de las utilidades y minimización de costes sin afectar la calidad brindada al cliente. El objetivo de este restaurante es que el área de recursos humanos sea restructurada en cada uno de los procesos para articularla al direccionamiento estratégico de Kathmandu; pues en esta área se generan la mayoría de los problemas presentados anteriormente. El presente proyecto pretende diseñar el direccionamiento estratégico del área recursos humanos del restaurante Kathmandu para superar la problemática identificada y garantizar la efectividad de sus procesos y adicionalmente evidenciar la creencia de éxito sostenido que se manejaba en este lugar. Este proyecto se realizara con una metodología mixta, para tener aspectos de la investigación cuantitativa y cualitativa y poder realizar una investigación más completa que lleve a una óptima solución del problema abarcado. Se utilizara el direccionamiento estratégico como herramienta para replantear el área de recursos humanos de la organización y alcanzar la efectividad en sus procesos.

Impacto de la implementación de un modelo de gestión integral de atención de la enfermedad y cuidado coordinado en la población en diálisis en Colombia

La atención hospitalaria en el costo global de la atención de los pacientes en diálisis es muy importante. Este estudio se realizó con el fin de evaluar resultados posteriores a la implementación de un modelo de gestión de la enfermedad y cuidado coordinado en una red de diálisis en Colombia, evaluando los cambios específicos en las tasas de hospitalización de una cohorte de pacientes renales con dos años de seguimiento. El modelo se enfoca básicamente en mejorar la atención de los pacientes en diálisis protocolizando en el manejo de comorbilidades (diabetes, riesgo cardiovascular, patologías infecciosas) y en el cuidado coordinado entre el tratamiento ambulatorio y hospitalario de los pacientes en diálisis asegurando la continuidad en el proceso de atención de los pacientes. El Estudio observacional analítico de cohortes compuesto por 2 fases una primera cohorte histórica retrospectiva y una segunda con dos cohortes prospectivas, incluyó pacientes mayores de 18 años, con más de 90 días en diálisis, con al menos tres meses de intervención con el modelo de gestión de enfermedad en la red Renal Therapy Services (RTS®). En conclusión, la realización de este estudio, se pudo asociar a la reducción en la atención hospitalaria de pacientes en diálisis y a una menor mortalidad, modelos como este y otras soluciones para mejorar los desenlaces en salud en los pacientes en diálisis deben seguir siendo implementados para aliviar la carga de la enfermedad y reducir los costos de la atención en salud de esta población.

Retos en la implementación de las normas internacionales al interior de los estados. estudio de caso: la región del Mekong y el protocolo de Palermo contra la trata de personas. (2007-2014)

El presente estudio de caso tiene como principal objetivo el de analizar la manera como las características sociopolíticas de los Estados del Mekong, específicamente en el caso de Camboya y Myanmar, dificultan la implementación de las normas enunciadas en el Protocolo de las Naciones Unidas para Prevenir, Reprimir y Sancionar la Trata de Personas, Especialmente Mujeres y Niños, también conocido como el Protocolo de Palermo. En este sentido, se parte de las características principales del Protocolo y de la manera como el tráfico de personas se presenta en el Mekong para posteriormente analizar la forma como la corrupción, la impunidad y la desigualdad de género representan retos sociopolíticos que obstruyen la implementación de los mandatos internacionales enmarcados en este instrumento

Quality of Judgment Assessment

The intersection of Artificial Intelligence and The Law stands for a multifaceted matter, and its effects set the advances on culture, organization, as well as the social matters, when the emergent information technologies are taken into consideration. From this point of view, the weight of formal and informal Conflict Resolution settings should be highlighted, and the use of defective data, information or knowledge must be emphasized. Indeed, it is hard to do it with traditional problem solving methodologies. Therefore, in this work the focus is on the development of decision support systems, in terms of its knowledge representation and reasoning procedures, under a formal framework based on Logic Programming, complemented with an approach to computing centered on Artificial Neural Networks. It is intended to evaluate the Quality-of-Judgments and the respective Degree-of-Confidence that one has on such happenings.

Screening a Case Base for Stroke Disease Detection

Stroke stands for one of the most frequent causes of death, without distinguishing age or genders. Despite representing an expressive mortality fig-ure, the disease also causes long-term disabilities with a huge recovery time, which goes in parallel with costs. However, stroke and health diseases may also be prevented considering illness evidence. Therefore, the present work will start with the development of a decision support system to assess stroke risk, centered on a formal framework based on Logic Programming for knowledge rep-resentation and reasoning, complemented with a Case Based Reasoning (CBR) approach to computing. Indeed, and in order to target practically the CBR cycle, a normalization and an optimization phases were introduced, and clustering methods were used, then reducing the search space and enhancing the cases re-trieval one. On the other hand, and aiming at an improvement of the CBR theo-retical basis, the predicates` attributes were normalized to the interval 0…1, and the extensions of the predicates that match the universe of discourse were re-written, and set not only in terms of an evaluation of its Quality-of-Information (QoI), but also in terms of an assessment of a Degree-of-Confidence (DoC), a measure of one`s confidence that they fit into a given interval, taking into account their domains, i.e., each predicate attribute will be given in terms of a pair (QoI, DoC), a simple and elegant way to represent data or knowledge of the type incomplete, self-contradictory, or even unknown.

AGENDA AMBIENTAL DEL AGUA EN COSTA RICA

La crisis de gobcrnabilidad de los recursos hídricos es clara y evidente en Costa Rica. Estos recursos están en proceso de deterioro y peligrosamente amenazados. En tan solo cinco décadas se pasó de la riqueza y abundancia de agua, a la vulnerabilidad y escasez de ésta. Un conjunto de realidades ha originado la mencionada crisis: la ausencia de políticas hídricas integrales, claras y estables, un marco legal desactualizado. estático y de mínimo cumplimiento, que ha permitido el uso ineficiente y la contaminación de los cuerpos de agua y desde luego la cultura dominante de poca o ninguna valoración del agua como recurso vital para el desarrollo presente y futuro de todas las especies que poblamos el país.La Agenda Ambiental del Agua en Costa Rica ha sido elaborada mediante un proceso parlicipativo. donde diversos actores sociales en diferentes regiones —Limón, Liberia y la Gran Area Metropolitana (GAM)— priorizaron los 10 principales problemas y sus potenciales soluciones:1) La educación formal e informal es muy débil respecto a como alcanzar el uso eficiente e inteligente de los recursos hrdricos. Igualmente, es débil para revertir el patrón de manejo de vertidos sin responsabilidad social.2) La excesiva centralización de las decisiones. Muy poca participación ciudadana tanto en la estructura organizativa como en la toma de decisiones.3) La inoperancia del marco institucional y legal —desconocimiento por parte de la sociedad civil de los procesos de denuncia y otros; la tramitología de denuncia es demasiado lenta e ineficiente, razón por la cual los denunciantes se cansan y desaniman—.4) La deficiente y casi nula valoración económica del agua, que tome en cuenta el manejo integral de las cuencas y la búsqueda de la permanencia del recurso en el futuro.5) La ausencia de planes hídricos de cuencas donde el plan regulador sea un componente básico.6) La desigual calidad del agua para los costarricenses según operador del servicio y región geográfica.7) La contaminación de aguas superficiales y subterráneas.8) La ausencia de conocimiento, socialización, sistematización y movilización en relación con el manejo del agua. Es necesario el aumento de las capacidades tanto técnicas y científicas como de cambio de cultura y conocimiento popular.9) Falta de información básica y mecanismos claros para poder utilizarla.10) La información existente en la actualidad se encuentra dispersa en diferentes orgarnza ciones y en algunos investigadores, lo que impide su uso efectivo.La Agenda Ambiental del Agua en Costa Rica aproxima los costos para la solución de los problemas apuntados anteriormente. Se necesita invertir alrededor de US$J .500 millones para abordar la gestión integrada de los recursos hídricos en el país.Abstract: The crisis of governance of thc watcr resources is clear and evideni in Costa Rica. These resources are in proccss oídeterioration anddangerously threatened. In only five decades it passed of che wealth and water abundance, to che vulnerability and shortagc of thc same one. A set of realities has originated dic mentioned crisis; dic abscncc of an integral, clear and siable water policy, a legal framework out of date. static one and of minimal fulfillmeni. which has allowed che inefficicrn use and ihe pollution ofihe water bodies. And certainly. hc dominecring culture of small ci no valuation to the water as vital resource for thc prcscnt and future dcvclopment of alI dic species. thai we populate che country.The Environmental Agenda of the Water in Costa Rica has bccn claborated by means of a participatory proccss. which includes several social actors in diverse regions —Limon. Liberia and Great Metropolitan Area (GAM) These actors prioritized lO principal problems related to water resources and thcir potential solutions:1) The formal and informal education is very weak with regard to since as reaches the efficient and intelligeni use of thc water resources. Equally. dic boss of managing is weak for revert of spilt without social responsibilicy.2) The excessive centralization of che decisions with very little civil parlicipation. both in the organizational siructure and in the decision making process.3) The un.workability of ihe institutional and legal framewoik —ignorance cii che pan of civil society of che proces.ses of denunciation and others the denunciation niechanism is ioo slow and inefticieni, a reason for which dic cbtmants get tired and discouragc—.4) Thedeficientone and almosi voideconomic valuationofthe waier. which bears in mmd the integral managing of the basin and dic scarc h of dic permancncy of dic resource to future.5) Thc absence of water plans of basin where dic regulatory plan is a basic component.6) The unequal quality of the water for dic Costa Ricans according tooperacor of dic service and geographica] region.7) The pollution of superficial and underground waters.8) The absence of knowledgc. socializ.arion, systematizing and mobilization in relation co the waier managing. Thc increase of dic capacities is necessary so much tcchnical and scicntific like of change of culture and popular knowledge.9) Lack of basic information and clear mechanisms to be able to use it.10) Thc cxisting information aL preseni is dispersed in different organizations and in sorne investigators, which prevents ihe effective use of the same one.The Environmental Agenda of the Water in Costa Rica brings the costs near for the solution of the pointed problems previously. Costa Rica needs to invest about US$1.500 million Lo approach ihe integrated managcment of the water resources in the country.

Mechanical design and hybrid control strategies for overconstrained cable-driven parallel robots

Cable-driven parallel robots offer significant advantages in terms of workspace dimensions and payload capability. They are attractive for many industrial tasks to be performed on a large scale, such as handling and manufacturing, without a substantial increase in costs and mechanical complexity with respect to a small-scale application. However, since cables can only sustain tensile stresses, cable tensions must be kept within positive limits during the end-effector motion. This problem can be managed by overconstraining the end-effector and controlling cable tensions. Tension control is typically achieved by mounting a load sensor on all cables, and using specific control algorithms to avoid cable slackness or breakage while the end-effector is controlled in a desired position. These algorithms require multiple cascade control loops and they can be complex and computationally demanding. To simplify the control of overconstrained cable-driven parallel robots, this Thesis proposes suitable mechanical design and hybrid control strategies. It is shown how a convenient design of the cable guidance system allows kinematic modeling to be simplified, without introducing geometric approximations. This guidance system employs swiveling pulleys equipped with position and tension sensors and provides a parallelogram arrangement of cables. Furthermore, a hybrid force/position control in the robot joint space is adopted. According to this strategy, a particular set of cables is chosen to be tension-controlled, whereas the other cables are length-controlled. The force-controlled cables are selected based on the computation of a novel index called force-distribution sensitivity to cable-tension errors. This index aims to evaluate the maximum expected cable-tension error in the length-controlled cables if a unit tension error is committed in the force-controlled cables. In practice, the computation of the force-distribution sensitivity allows determining which cables are best to be force-controlled, to ensure the lowest error in the overall force distribution when a hybrid force/position joint-space strategy is used.

Structural Connectivity Of The Default Mode Network And Cognition In Alzheimer׳s Disease.

Disconnectivity between the Default Mode Network (DMN) nodes can cause clinical symptoms and cognitive deficits in Alzheimer׳s disease (AD). We aimed to examine the structural connectivity between DMN nodes, to verify the extent in which white matter disconnection affects cognitive performance. MRI data of 76 subjects (25 mild AD, 21 amnestic Mild Cognitive Impairment subjects and 30 controls) were acquired on a 3.0T scanner. ExploreDTI software (fractional Anisotropy threshold=0.25 and the angular threshold=60°) calculated axial, radial, and mean diffusivities, fractional anisotropy and streamline count. AD patients showed lower fractional anisotropy (P=0.01) and streamline count (P=0.029), and higher radial diffusivity (P=0.014) than controls in the cingulum. After correction for white matter atrophy, only fractional anisotropy and radial diffusivity remained significantly lower in AD compared to controls (P=0.003 and P=0.05). In the parahippocampal bundle, AD patients had lower mean and radial diffusivities (P=0.048 and P=0.013) compared to controls, from which only radial diffusivity survived for white matter adjustment (P=0.05). Regression models revealed that cognitive performance is also accounted for by white matter microstructural values. Structural connectivity within the DMN is important to the execution of high-complexity tasks, probably due to its relevant role in the integration of the network.

Paired Evaluation Of Calvarial Reconstruction With Prototyped Titanium Implants With And Without Ceramic Coating.

To investigate the osseointegration properties of prototyped implants with tridimensionally interconnected pores made of the Ti6Al4V alloy and the influence of a thin calcium phosphate coating. Bilateral critical size calvarial defects were created in thirty Wistar rats and filled with coated and uncoated implants in a randomized fashion. The animals were kept for 15, 45 and 90 days. Implant mechanical integration was evaluated with a push-out test. Bone-implant interface was analyzed using scanning electron microscopy. The maximum force to produce initial displacement of the implants increased during the study period, reaching values around 100N for both types of implants. Intimate contact between bone and implant was present, with progressive bone growth into the pores. No significant differences were seen between coated and uncoated implants. Adequate osseointegration can be achieved in calvarial reconstructions using prototyped Ti6Al4V Implants with the described characteristics of surface and porosity.

Genetic Diversity Of Giardia Duodenalis: Multilocus Genotyping Reveals Zoonotic Potential Between Clinical And Environmental Sources In A Metropolitan Region Of Brazil.

Giardia duodenalis is a flagellate protozoan that parasitizes humans and several other mammals. Protozoan contamination has been regularly documented at important environmental sites, although most of these studies were performed at the species level. There is a lack of studies that correlate environmental contamination and clinical infections in the same region. The aim of this study is to evaluate the genetic diversity of a set of clinical and environmental samples and to use the obtained data to characterize the genetic profile of the distribution of G. duodenalis and the potential for zoonotic transmission in a metropolitan region of Brazil. The genetic assemblages and subtypes of G. duodenalis isolates obtained from hospitals, a veterinary clinic, a day-care center and important environmental sites were determined via multilocus sequence-based genotyping using three unlinked gene loci. Cysts of Giardia were detected at all of the environmental sites. Mixed assemblages were detected in 25% of the total samples, and an elevated number of haplotypes was identified. The main haplotypes were shared among the groups, and new subtypes were identified at all loci. Ten multilocus genotypes were identified: 7 for assemblage A and 3 for assemblage B. There is persistent G. duodenalis contamination at important environmental sites in the city. The identified mixed assemblages likely represent mixed infections, suggesting high endemicity of Giardia in these hosts. Most Giardia isolates obtained in this study displayed zoonotic potential. The high degree of genetic diversity in the isolates obtained from both clinical and environmental samples suggests that multiple sources of infection are likely responsible for the detected contamination events. The finding that many multilocus genotypes (MLGs) and haplotypes are shared by different groups suggests that these sources of infection may be related and indicates that there is a notable risk of human infection caused by Giardia in this region.

Orthognathic Surgery With Or Without Induced Hypotension.

This study involved a retrospective evaluation of patients subjected to surgery for dentofacial deformities treated without induced controlled hypotension (group I, n=50) and a prospective evaluation of patients who were subjected to surgery under hypotensive general anaesthesia (group II, n=50). No statistical differences were found between the study groups with regard to the duration of surgery. However, there were statistically significant differences in the need for blood transfusion and the occurrence of bradycardia during the maxillary down-fracture. Hypotensive anaesthesia decreased the need for a blood transfusion and the occurrence of bradycardia, and is therefore considered highly beneficial for patients undergoing orthognathic surgery.

Implantation Of Transcatheter Aortic Valve Prosthesis Through The Ascending Aorta Concomitant With Coronary Artery Bypass Grafting Without Cardiopulmonary Bypass.

Introdution: The transcatheter aortic valve implantation in the treatment of high-risk symptomatic aortic stenosis has increased the number of implants every year. The learning curve for transcatheter aortic valve implantation has improved since the last 12 years, allowing access alternatives. The aim of this study is to approach the implantation of transcatheter aortic valve through transaortic via associated with off-pump cardiopulmonary bypass surgery in a 67-year-old man, with chronic obstructive pulmonary disease, arterial hypertension and kidney transplant. Off-pump coronary artery bypass surgery was performed and the valve in the aortic position was released successfully. There were no complications in the intraoperative and postoperative period. Gradient reduction, effective orifice increasing of the prosthesis and absence of valvular regurgitation after implantation were observed by transesophageal echocardiography. Procedural success demonstrates that implantation of transcatheter aortic valve through the ascending aorta associated with coronary artery bypass surgery without CPB is a new option for these patients.

Predictors Of Silent Myocardial Ischemia In Resistant Hypertensive Patients.

Hypertension is the most prevalent and significant modifiable risk factor for coronary heart disease. A portion of patients with uncontrolled hypertension are considered to have resistant hypertension (RHTN). Myocardial ischemia incidence increases along with blood pressure (BP) levels. However, the prevalence of myocardial ischemia in patients with RHTN, as well as the factors associated with it, is unknown. We enrolled 129 patients with true RHTN regularly followed in our specialty hypertension clinic and evaluated then by resting and dipyridamole pharmacological stress myocardial perfusion scintigraphy. Patients were then divided into 2 groups: those with (I-RHTN; n = 36) and those without (NI-RHTN; n = 93) myocardial ischemia. Echocardiography, 24-hour ambulatory BP monitoring (ABPM), and flow mediated dilation (FMD) were also evaluated. Thirty six (28%) patients had myocardial ischemia. There was no difference between groups regarding age, sex, biochemical parameters, office, and 24-hour ABPM levels. Patients in the I-RHTN group were more likely diabetic (31% vs. 11%; P < 0.05) and obese (75% vs. 40%; P < 0.001). Adjusting for age and body mass index, multiple logistic regression showed that diabetes (odds ratio (OR) = 6.5; 95% confidence interval (CI) = 1.06-40.14; P = 0.04), FMD (OR = 0.18; 95% CI = 0.07-0.41; P < 0.001), heart rate (OR = 1.23; 95% CI = 1.11-1.36; P < 0.001), left ventricular mass index (OR = 1.02; 95% CI = 1.01-1.04; P = 0.04), and microalbuminuria (OR = 1.02; 95% CI = 1.01-1.04; P = 0.002) were independent predictors of ischemia. In conclusion, there is a high prevalence of myocardial ischemia in patients with RHTN. Increased microalbuminuria, heart rate, endothelial dysfunction, and left ventricular mass can be useful to guide the investigation for myocardial ischemia in these high risk patients.

Patterns Of Seizure Control In Patients With Mesial Temporal Lobe Epilepsy With And Without Hippocampus Sclerosis.

Objective Patients with mesial temporal lobe epilepsy (MTLE) may present unstable pattern of seizures. We aimed to evaluate the occurrence of relapse-remitting seizures in MTLE with (MTLE-HS) and without (MTLE-NL) hippocampal sclerosis. Method We evaluated 172 patients with MTLE-HS (122) or MTLE-NL (50). Relapse-remitting pattern was defined as periods longer than two years of seizure-freedom intercalated with seizure recurrence. Infrequent seizures was considered as up to three seizures per year and frequent seizures as any period of seizures higher than that. Results Thirty-seven (30%) MTLE-HS and 18 (36%) MTLE-NL patients had relapse-remitting pattern (X2, p = 0.470). This was more common in those with infrequent seizures (X2, p < 0.001). Twelve MTLE-HS and one MTLE-NL patients had prolonged seizure remission between the first and second decade of life (X2, p = 0.06). Conclusion Similar proportion of MTLE-HS or MTLE-NL patients present relapse-remitting seizures and this occurs more often in those with infrequent seizures.