RESUMEN
One of the factors responsible for lack of reproducible findings may be attributed to the raw material used. To date, there are no apparent studies examining reproducibility using venoms for the development of new toxin-based drugs with respect to regulatory agencies' policies. For this reason, protocols were implemented to produce animal toxins with quality, traceability, and strict compliance with Good Manufacturing Practices. This required validation of the production chain from the arrival of the animal to the vivarium, followed by handling, housing, as well as compliance with respect to extraction, freeze-drying, and, finally, storage protocols, aimed at generating compounds to serve as candidate molecules applicable in clinical trials. Currently, to produce quality snake venoms to support reproductive studies, the Center for the Study of Venoms and Venomous Animals (CEVAP) from São Paulo State University (UNESP), São Paulo, Brazil has 449 microchipped snakes through rigid and standardized operating procedures for safety, health, and welfare of animals. Snakes were frequently subjected to vet clinical examination, anthelmintic, and antiparasitic treatment. Venom milk used to destroy prey was collected from each animal in individual plastic microtubes to avoid contamination and for traceability. In addition, venoms were submitted to microbiological, and biochemical toxicological analyses. It is noteworthy that investigators are responsible for caring, maintaining, and manipulating snakes and ensuring their health in captivity. This review aimed to contribute to the pharmaceutical industry the experimental experience and entire snake venom production chain required to generate quality products for therapeutic human consumption.
Asunto(s)
Productos Biológicos/uso terapéutico , Industria Farmacéutica/normas , Venenos de Serpiente/uso terapéutico , Animales , Productos Biológicos/normas , Brasil , Desarrollo de Medicamentos/legislación & jurisprudencia , Desarrollo de Medicamentos/normas , Humanos , Reproducibilidad de los Resultados , SerpientesRESUMEN
CONCLUSION: Hyperbaric oxygen treatment (HBOT) promoted an increase of the mean axonal diameter in the group evaluated 2 weeks after lesion induction, which suggests a more advanced regeneration process. However, the number of myelin nerve fibers of the facial nerve of the rabbits was similar when compared to the control and treatment groups, in both evaluation periods. OBJECTIVE: To evaluate the effect of HBOT on the histological pattern of the facial nerve in rabbits exposed to a nerve crush injury. MATERIALS AND METHODS: Twenty rabbits were exposed to facial nerve crush injury. Ten rabbits received HBOT, 10 rabbits comprised the control group. The rabbits were sacrificed 2 and 4 weeks after the trauma. Qualitative morphological analysis, measurement of the external axonal diameters and myelin fiber count were carried out in an area of 185 000 microm2. RESULTS: There was an increase in the area of the axons and thicker myelin in the 2 weeks treatment group in comparison with the control group. The mean diameter of the axons was of 2.34 microm in the control group and of 2.81 microm in the HBOT group, with statistically significant differences. The 2 week control group had a mean number of myelin fibers of 1865.2 +/- 664, and the HBOT group had a mean number of 2026.3 +/- 302; this was not statistically significant. The 4 week control group presented a mean of 2495.1 +/- 479 fibers and the HBOT group presented a mean of 2359.9 +/- 473; this was not statistically significant.
Asunto(s)
Traumatismos del Nervio Facial/patología , Traumatismos del Nervio Facial/terapia , Oxigenoterapia Hiperbárica , Regeneración Nerviosa , Animales , Axones/patología , Axones/fisiología , Nervio Facial/patología , Nervio Facial/fisiopatología , Traumatismos del Nervio Facial/fisiopatología , Masculino , Vaina de Mielina/patología , Vaina de Mielina/fisiología , Compresión Nerviosa , Conejos , Factores de TiempoRESUMEN
A displasia fibrosa é lesäo pseudo-neoplásica de etiologia desconhecida, caráter benigno e recidivante, caracterizada pelo desenvolvimento de tecido fibroso e traves osteóides que substituem gradualmente o osso normal. O principal diagnóstico diferencial da forma monostótica, no envolvimento dos ossos da cabeça e pescoço, é o fibroma ossificante, que alguns consideram variante desta entidade. Esse trabalho tem como objetivo revisar as principais características clínicas, radiológicas e histopatológicas que auxiliam no diagnóstico diferencial da displasia fibrosa com o fibroma ossificante e discutir o comportamento recidivante da displasia fibrosa, essencial ao planejamento cirúrgico. Relatamos três casos provenientes do ambulatório de Otorrinolaringologia da Santa Casa de Misericórdia de Säo Paulo, avaliados quanto às queixas, exame físico, achados de imagem e tratamentos. Nos três casos o diagnóstico foi confirmado pelo exame anatomopatológico. Todos apresentaram recidiva após a ressecçäo cirúrgica, diagnosticada entre o primeiro e o oitavo ano de seguimento. Devido ao comportamento clínico semelhante da displasia fibrosa e do fibroma ossificante, o exame anatomopatológico é essencial para o diagnóstico diferencial. O acompanhamento clínico permanente desses pacientes é necessário para que as possíveis recidivas sejam diagnosticadas precocemente
RESUMEN
A síndrome de Melkersson-Rosenthal é rara, de etiologia desconhecida e de provável predisposiçäo hereditária. Caracteriza-se pela presença de edema orofacial recidivante, língua plicata e episódios recorrentes de paralisia facial periférica. Após surtos repetidos, déficits permanentes da movimentaçäo facial podem ser responsáveis por transtornos na comunicaçäo, na alimentaçäo e alteraçöes estéticas que determinam danos psíquicos aos pacientes. A abordagem terapêutica da paralisia facial periférica nesta síndrome merece atençäo especial e diferenciada das outras etiologias. Nosso objetivo é revisar as características clínicas e discutir as opçöes terapêuticas existentes na literatura com a desta casuística. Relatamos quatro casos clínicos com paralisia facial periférica e confrontamos os tratamentos instituídos com os dados provenientes da revisäo da literatura. Dois dos casos relatados apresentaram evoluçäo favorável da paralisia facial mesmo sem tratamento medicamentoso, os outros dois casos foram submetidos à descompressäo do nervo facial. Em um deles, houve recuperaçäo significativa da movimentaçäo facial. O outro mostrou recorrência da paralisia mesmo após a descompressäo parcial. Os pacientes com a síndrome de Melkersson-Rosenthal e que exibem paralisia facial com má evoluçäo ou quadros recidivantes, podem ser abordados cirurgicamente