RESUMO
Este trabajo tiene como objetivo revisar las contribuciones de la biotecnología, en relación con el tratamiento, diagnóstico y la monitorización de la enfermedad renal crónica (ERC) y sus comorbilidades más frecuentes, especialmente la anemia. En relación con los tratamientos, enfocamos el desarrollo de productos biofarmacéuticos como los agentes estimulantes de la eritropoyesis (ESA), que fueron los primeros biofármacos utilizados para el tratamiento de la anemia asociada a la ERC; analizamos sus características y utilización actual después de varios años de experiencia clínica, así como también otras alternativas en desarrollo. Revisamos distintos tipos de bioterapias, la utilización de las células estromales mesenquimales de médula ósea (MSC) y tratamientos alternativos con modificaciones dietarias, que se basan en la asociación entre la microbiota intestinal de los pacientes renales crónicos y sus condiciones fisiopatológicas. Finalmente, en relación con el diagnóstico y monitorización, nos referimos al estudio y validación de biomarcadores diagnósticos, predictivos y terapéuticos que han permitido optimizar los resultados clínicos en este tipo de pacientes. (AU)
The aim of this work is to review the contributions of biotechnology, in relation to the treatment, diagnosis and monitoring of chronic kidney disease (CKD) and its most frequent comorbidities, especially anemia. Regarding the treatment, we focus on the development of biopharmaceutical products such as erythropoiesis stimulating agents (ESA), which were the first biopharmaceuticals used to treat anemia associated with chronic kidney disease (CKD). We analyzed their characteristics and their current use after several years of clinical experience, as well as other alternatives in development. We also review different types of biotherapies, the use of bone marrow mesenchymal stromal cells (MSC) and alternative treatments with dietary modifications, which are based on the association between the intestinal microbiota of chronic kidney patients and their pathophysiological conditions. Finally, in relation to diagnosis and monitoring, we refer to the study and validation of diagnostic, predictive and therapeutic biomarkers that have made clinical results possible to be optimized in this type of patient. (AU)
Assuntos
Humanos , Terapia Biológica/tendências , Insuficiência Renal Crônica/terapia , Qualidade de Vida , Biotecnologia , Biomarcadores , Eritropoetina/deficiência , Probióticos/uso terapêutico , Transplante de Células-Tronco Mesenquimais/tendências , Eritropoese/efeitos dos fármacos , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/dietoterapia , Insuficiência Renal Crônica/reabilitação , Prebióticos/classificação , Inibidores de Glicosídeo Hidrolases/uso terapêutico , Microbioma Gastrointestinal , Hematínicos/administração & dosagem , Hematínicos/farmacologia , Hematínicos/farmacocinética , Anemia/diagnóstico , Anemia/etiologia , Anemia/tratamento farmacológicoRESUMO
Biotherapeutic products (BPs) have revolutionized medicine, changing the way we treat several pathologies such as autoimmune diseases and cancer, among others. Herein, we present an overview of similar BPs (SBPs), also called biosimilars, including the manufacturing process and regulatory aspects involved. The objective of developing an SBP is to manufacture a molecule that is highly similar to a reference BP by conducting a comparability exercise (CE) that can demonstrate similar safety and efficacy. This CE consists of quality, as well as nonclinical and clinical evaluation. A case-by-case analysis approach guided by scientific and objective standards must be the foundation for the SBP approval process. The establishment of a balance between a comprehensive CE for SBPs and their reference BPs, and the design of costeffective strategies to provide better access to BPs, should be the key goal for national regulatory authorities.
Assuntos
Doenças Autoimunes/terapia , Terapia Biológica/métodos , Medicamentos Biossimilares/uso terapêutico , Terapia de Alvo Molecular , Neoplasias/terapia , Animais , Terapia Biológica/tendências , Biotecnologia , Aprovação de Drogas , Desenho de Fármacos , HumanosRESUMO
Os autores discutem a terapêutica para a artrite reumatoide (AR), com foco no tratamento biológico. Novos conhecimentos dos mecanismos patogênicos da AR mais a aplicação de biotecnologia propiciaram o desenvolvimento de tratamentos específicos contra moléculas envolvidas na inflamação da doença, os chamados tratamentos biológicos. Estes fármacos representam o maior avanço no controle da AR nesta última década. 0s agentes biológicos habitualmente aprovados para uso na AR são: etanercepte, receptor solúvel do TNE infliximabe e adalimumabe, ambos anticorpos monoclonais contra TNF. Todos estão disponíveis para uso pela secretaria de saúde. Outros aprovados para uso e não disponibilizados pela secretaria são o rituximabe e o abatacepte. Neste artigo discutimos cada um destes biológicos.
Authors discuss the therapies for rheumatoid arthritis focused on biological therapies. Biological therapies are the result of new insights into the pathogenic mechanisms of RA and the application of biotechnology on the development of therapies directed specifically against molecules involved with the inflammatory process of the disease. These agents represent the greatest advance in the control of RA during the last decade. Biological agents currently approved and accessible by government for the treatment of RA include: etanercept, a soluble recombinant anti-TNF receptor construct, in fliximab and adalimumab, both monoclonal antibodies against TNF. The others biologic, rituximab and abatacept, are also approved for treatment of RA but not available by government. In this essay authors study each one of these biologics agents.
Assuntos
Humanos , Masculino , Feminino , Artrite Reumatoide/etiologia , Artrite Reumatoide/fisiopatologia , Artrite Reumatoide/terapia , Anti-Inflamatórios não Esteroides , Antirreumáticos , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Imunossupressores/uso terapêutico , Terapia Biológica/tendências , Terapia Combinada/tendênciasRESUMO
Dano e perda de células ciliadas na orelha externa é a causa mais frequente de perda auditiva, desde que a perda das células ciliadas de mamíferos é irreversível. O tratamento de perda auditiva consiste o uso de aparelhos de amplificação sonora ou implante cocleares, porém ambos...
Damage and loss of hair cells in the inner ear is the most frequent cause of hearing loss, since mammalian hair cells are not replenishid once lost. The treatment of hearing loss consists of hearing aids or cochlear implants, but both...
Assuntos
Perda Auditiva/cirurgia , Terapia Biológica/tendências , Transplante de Células-Tronco/tendências , Células CultivadasRESUMO
Introducción: el propósito del presente estudio fue demostrar la efectividad del extracto de las fracciones ribosómicas bacterianas como tratamiento del linfangioma en niños. Material y métodos: se realizó un análisis prospectivo de enero de 2003 a enero de 2006 de los pacientes que consultaron con diagnóstico de linfangioma en quienes se administró intracavitariamente extracto de fracciones ribosómicas bacterianas como único régimen terapéutico. Se aplicaron de 1 a 3 infiltraciones seriados con un intervalo de 1 mes entre cada uno...
Assuntos
Criança , Linfangioma/terapia , Streptococcus pyogenes/isolamento & purificação , Terapia Biológica/tendênciasRESUMO
El papel crítico del remodelamiento de la cromatina en la expresión de los genes se halla bajo la influencia de los cambios epigenéticos que conforman un lenguaje inesperado en el DNA y las histonas. Este trabajo actualiza el conocimiento sobre la metilación del DNA y la acetilación de las histonas, con especial interés en su aplicación clínica. Se ha propuesto, la identificación de los patrones heredables de metilación como herramienta útil en el diagnóstico y pronóstico del cáncer. Los inhibidores de las DNA-metiltransferasas y de las desacetilasas de histonas que actúan como reprogramadores de la expresión génica, han generado una nueva y promisoria aproximación terapéutica
Assuntos
Código Genético/genética , Metilação de DNA , Terapia Biológica/métodos , Terapia Biológica/tendênciasRESUMO
The fusion of a murine B cell and a myeloma cell generates a hybridoma that produces monoclonal antibody (mAb). These murine mAb induce the HAMA (human anti-mouse antibodies) response. Murine mAb have been modified by genetic engineering, producing molecules with a higher proportion of human protein. At present, chimeric, humanized and fully human mAb are available. mAb block interactions between target molecules and their ligands or trigger the lyses of mAb-coated tumor cells. Numerous mAb have been developed using the recombinant DNA technology and several are available in the market. Trastuzumab, against HER2/neu, is useful in breast cancer; rituximab, against CD20 in B lymphocytes is useful in lymphoma; alemtuzumah, against CD52 is used in lymphoma and leukemia; daclizumab and basiliximab block the IL-2 receptor interaction and reduce acute rejection in kidney transplantation; abciximab, an antagonist of GPIIb/IIIa platelet receptor, is used in patients undergoing acute coronary syndromes. In autoimmunity diseases, blocking tumor necrosis factor by infliximab and adalimumab has demonstrated excellent results. Thus, infliximab is useful in the treatment of rheumatoid arthritis (RA), Crohn's disease and ulcerative colitis while adalimumab is the first fully human mAb available for RA. Infliximab and adalimumab reduce signs and symptoms in RA and they also interfere with progression of joint damage. Finally, the direct benefits of antagonist treatment can occur at the expense of a major adverse effect in some other biological function.