RESUMO
OBJECTIVES: To carry out an assessment of parenteral nutrition (PN) practices in hospital pharmacies of the Auvergne-Rhône-Alpes region in order to explore a harmonisation of practices and a collaboration between the different centres. METHODS: Status of practices was carried out on the basis of an observational study inspired by the survey of the General Inspectorate of Social Affairs. It was carried out in Auvergne-Rhône-Alpes region in four university hospital pharmacies with a production unit of PN. It focused on the different stages of the PN process: prescription, formulation, compounding and quality control. It also covered the support processes such as the quality assurance system and the management of premises and equipment. RESULTS: Most preparations made in the region are individualized parenteral nutritional admixtures for paediatric and neonatal hospitalization departments. The production units of PN of each centre are located in premises in compliance with Good Preparation Practices. However, compounding equipment and raw materials used are heterogeneous in the four centres. All centres control the quality of their finished preparations. But, the performance of analytical control is disparate in terms of equipment and specifications. CONCLUSION: This assessment explains the similarities and differences in PN practices between various university hospitals in the Auvergne-Rhône-Alpes region and thus makes possible to provide a collective regional work to harmonise practices.
Assuntos
Farmácias , Recém-Nascido , Humanos , Criança , Hospitais Universitários , Nutrição Parenteral , Soluções de Nutrição Parenteral , Inquéritos e QuestionáriosRESUMO
PURPOSE: Neoplastic meningitis is often the final outcome of disseminated cancer and is rapidly lethal. Its limited treatment relies on systemic or intrathecal chemotherapy with methotrexate (MTX) or thiotepa. When 5-iodo-2'-deoxyuridine labeled with (125)I ((125)IUdR) is incorporated into the DNA of mitotic tumor cells, the Auger electrons emitted during iodine decay are highly cytotoxic. The radiotherapeutic efficacy of (125)IUdR administered intrathecally has also been established in animals bearing spinal cord tumors, and MTX is known to potentiate the response. This approach has not been tested in the clinic. METHODS: A 44-year-old woman, with locally advanced pancreatic cancer, was treated for three years with complete systemic remission, but then relapsed with cytologically proven neoplastic meningitis. The patient was given four successive intrathecal injections of MTX (10 mg) every 12 h and, with the fourth dose, 1850 MBq (125)IUdR, followed by four additional MTX doses. The response was monitored by cytology and CA19.9 (carbohydrate antigen 19.9) levels in the cerebrospinal fluid (CSF) as well as by clinical status of the patient. RESULTS: The follow-up of cytology and CA19.9 levels in the CSF showed dramatic improvement within 26 days followed by a biological relapse on Day +36. There was no evidence of local central nervous system toxicity. Three months later, neoplastic meningitis recurred and meningeal tumor infiltration was observed on magnetic resonance imaging. Six months after MTX-(125)IUdR treatment, the patient died. CONCLUSION: (125)IUdR treatment proved to be feasible without acute neurological toxicity and seemed to have produced a biological response. This attempt provides the basis for designing prospective clinical trials.
Assuntos
Antibióticos Antineoplásicos/uso terapêutico , Idoxuridina/uso terapêutico , Neoplasias Meníngeas/tratamento farmacológico , Neoplasias Meníngeas/radioterapia , Metotrexato/uso terapêutico , Compostos Radiofarmacêuticos/uso terapêutico , Adulto , Antibióticos Antineoplásicos/administração & dosagem , Antígenos Glicosídicos Associados a Tumores/líquido cefalorraquidiano , Neoplasias Encefálicas/tratamento farmacológico , Neoplasias Encefálicas/radioterapia , Neoplasias Encefálicas/secundário , Terapia Combinada , Resistencia a Medicamentos Antineoplásicos , Evolução Fatal , Feminino , Humanos , Idoxuridina/administração & dosagem , Injeções Espinhais , Radioisótopos do Iodo , Neoplasias Meníngeas/secundário , Metotrexato/administração & dosagem , Recidiva Local de Neoplasia , Neoplasias Pancreáticas/tratamento farmacológico , Neoplasias Pancreáticas/patologia , Compostos Radiofarmacêuticos/administração & dosagemRESUMO
The EU regulation 536/2014 aims to facilitate the experimental use of diagnostic radiopharmaceuticals in particular for GMP requirements and needs to be applied in EU countries. As definitely clarified by this survey, the application is still far from being completed due to national restrictions that are conflicting with the content of the above EU regulation. Although the nuclear medicine centers are obliged to be compliant with national regulatory, national authorities have to be required to work towards full application of the regulation. On the other hand, an update of 536/2014 that includes therapeutic radiopharmaceuticals would also be beneficial to a rational and safe advance of nuclear medicine.
RESUMO
Two iodinated acetals of D-glucose, 4,6-(R)-O-(2'-iodoethylidene)-alpha, beta-D-glucose (1) and 4,6-(R)-O-(4'-iodobenzylidene)-alpha, beta-D-glucose (2), were prepared and their potential as suitable SPECT radioligands for imaging of glucose transporters was studied. Both are analogs of acetal D-glucose derivatives, which are known to bind to the exofacial sites of the glucose transport protein (GluT). To assess whether iodinated acetals 1 and 2 interacted with the glucose transporter, they were tested in vitro in human erythrocytes (GluT1) and neonatal rat cardiomyocytes (GluT4). The results indicated that 1 and 2 had a very low affinity for the glucose transporter and probably accumulated in cells. Study of their tissue distribution was carried out in the mouse in vivo: Both compounds showed fast tissue clearance with preferential renal elimination. It is concluded that iodinated acetals of D-glucose 1 and 2 are not suitable for GluT targeting in vivo.