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Spanish to English: Uso del Deferiprone en el Síndrome Mielodisplásico General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Spanish Título: "Estudio abierto sobre eficacia y seguridad del Deferiprone en el tratamiento de pacientes con Síndrome Mielodisplásico de Riesgo Bajo o Intermedio – 1 y sobrecarga de hierro post-transfusional. Prevención de la disfunción miocárdica evaluada con Resonancia Nuclear Magnética y Ferritina"
Análisis del “Problema”: Los pacientes con Síndromes Mielodisplásicos (SMD) de riesgo bajo e intermedio – 1 (según clasificación WHO) son politransfundidos en el 80 al 90 % de los casos y, como consecuencia, padecen insuficiencia cardíaca que los lleva a una muerte temprana. Otros órganos como el hígado, páncreas, glándulas endócrinas y articulaciones son también afectados por el exceso de hierro repercutiendo principalmente en la calidad de vida. Con el advenimiento de nuevas drogas, los quelantes orales, se ha abierto la posibilidad de evitar estas graves consecuencias y/o al menos paliarlas. El organismo humano no tiene una manera fisiológica de desembarazarse de la sobrecarga de hierro como sucede ante una ferropenia en donde naturalmente la absorción de hierro aumenta significativamente compensando el déficit. Existen 3 drogas quelantes de hierro, la más antigua y conocida de ellas es la deferroxamina, ésta se caracteriza por ser muy eficiente pero, en general es abandonada por los pacientes por incomodidad en su administración. En órden cronológico de aparición, el segundo quelante fue el Deferiprone (L1), éste tiene la virtud de ser oral, solucionar el problema anterior de la adaptación y ser muy eficiente en la insuficiencia cardíaca. Los estudios hasta el momento con esta droga se han realizado predominantemente en población joven portadora de síndromes talasémicos. Hay pocos casos reportados utilizando esta droga en otras patologías y es de destacar los cuidados que se deben tomar para evitar las consecuencias de uno de sus efectos adversos, la neutropenia. El tercer quelante oral es el deferasirox (ICL670), éste se encuentra en evaluación, existen protocolos abiertos utilizados en la enfermedad mielodisplásica; tiene la virtud de ser oral y tener una vida media prolongada. Entre los efectos adversos que requieren mayor recaudo, se menciona a la insuficiencia renal mientras que se necesitan más estudios para evaluar a la neutropenia.
Translation - English Title: "Open trial on the efficacy and safety of Deferiprone in the treatment of patients with Low- and Intermediate-1-Risk Myelodysplastic Syndrome and post-transfusion iron overload. Prevention of myocardial dysfunction evaluated with Magnetic Nuclear Resonance and Ferritine”.
Analysis of the “Problem”: Patients with low- and intermediate-1 risk Myelodysplastic syndromes (MDS) (as per WHO classification) are poly-transfused in 80 to 90% of the cases and, as a consequence thereof, suffer from heart failure leading to early death. Other organs, such as the liver, pancreas, endocrine glands and joints are also affected by iron excess, mainly affecting quality of life. With the advent of new drugs such as the oral chelating agents, the possibility of avoiding these severe consequences and/or at least alleviate them has arisen. The human organism lacks a physiological way to get rid of the iron overload, as happens in the face of an iron deficiency, where iron absorption naturally and significantly increases, thus compensating deficit. There are three iron chelating agents, the oldest and best known being deferroxamine, characteristic for its efficiency but generally abandoned by patients due to discomfort/inconveniences in its administration. The second chelating agent, in a chronological order of appearance, is Deferiprone (L1); this product having the virtue of being oral, thus solving previous adaptation problems and being very efficient as regards heart failure. Trials to date with this drug have been carried out mainly in a young population suffering from thalassemic syndromes. The cases which have been reported using this drug for other pathologies are few and a highlight must be focused on the care which must be adopted to avoid the consequences of one of its adverse effects, neutropenia. The third oral chelating agent is deferasirox (ICL670). This product is still being assessed, and there are open protocols being used on myelodysplastic disease; it has the virtue of being oral and has an extended mean life. Renal failure is mentioned among the adverse effects that require greater precautions while more trials are needed to evaluate neutropenia.
Justification and Viability of the Problem: This investigation study pretends to demonstrate that Deferiprone is efficient in avoiding the consequences of post-transfusion iron excess thus achieving an improvement in patients’ quality of life and prolonging their mean life. Besides, an attempt will be made to demonstrate that it is possible to safely control it most fearsome adverse effect: neutropenia, and its consequences. This last contingency will be avoided by carrying out weekly laboratory controls, educating patients, and whenever necessary, using granulocytic growth factors.
Formulation of Objectives and Hypothesis: High- and intermediate-1 risk MDS-carrying- patients, who receive deferiprone, will have no or few heart and/or other parenchymal lesions caused by iron excess, after the twentieth unit of red blood cells transfused. It will thus be possible to improve these patients` quality and length of life. The most fearsome adverse effect of deferiprone, neutropenia, can be safely managed.
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Years of experience: 29. Registered at ProZ.com: Aug 2009.
English to Spanish (CTPCBA) English to Spanish (Universidad Nacional del Museo Social Argentino) Spanish to English (CTPCBA) Spanish to English (Universidad Nacional del Museo Social Argentino)
Keywords: Especialización, industria farmacéutica, química, veterinaria, cosmética, ciencias de la salud, tecnología aplicada a la salud, CROs, servicio diferenciado, máxma calidad. See more.Especialización, industria farmacéutica, química, veterinaria, cosmética, ciencias de la salud, tecnología aplicada a la salud, CROs, servicio diferenciado, máxma calidad, confiabilidad, reserva, documentos técnicos y científicos, comerciales y de promoción, legales.. See less.
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