RESUMO
Facial lipoatrophy is a frequent adverse effect of HIV-infected patients due to antiretroviral therapy. Intradermal injection of polylactic acid (Newfill) is one of the currently available treatments. Newfill is a resorbable implant and follow-up has to be rigorous. The Pharmacy and the Infectious Diseases units at the Saint-Louis hospital implemented a follow-up procedure. A follow-up of treated patients was made for 20 months. 127 patients were included. The rate of traceability was 100%. Such traceability is therefore feasible and will have to be implemented for the follow-up of patients treated with future filling products.
Assuntos
Implantes Absorvíveis , Síndrome de Lipodistrofia Associada ao HIV/cirurgia , Ácido Láctico/análise , Polímeros/análise , Face , Feminino , Humanos , Masculino , PoliésteresRESUMO
French hospital pharmacists have been officially involved in the organization of clinical trials since 1988. New responsibilities included reception of clinical treatment units and nominative dispensation of these drugs. For quality assurance, they organized all the procedures to secure drugs utilization according to good clinical practices and ICH guidelines. The pharmacists can be participate in ethical counselling and training in methodology. For oncology trials, only a few pharmacies are involved because clinical trials for evaluation of cytotoxic drugs have been regulated by very strict standardized procedures since 1960 in accordance with international rules. Using these rules, Phase I studies determine the useful dose for human administration with tolerable toxicities. Phase II studies determine the efficacy in specific cancer localizations. Good response in a particular indication is usually followed by drug approval for Phase III. New clinical and biological end points are arising especially for new non-cytotoxic therapeutic agents. This activity is at the present time limited to inpatient treatments, but with the growing development of outpatient care networks, dispensary pharmacists will come to be more involved in the necessary research and development of new anticancer agents.
Assuntos
Antineoplásicos/uso terapêutico , Ensaios Clínicos como Assunto , Neoplasias/tratamento farmacológico , Farmacêuticos , Ensaios Clínicos Fase I como Assunto , Ensaios Clínicos Fase II como Assunto , Ensaios Clínicos Fase III como Assunto , Hospitais , Humanos , Projetos de PesquisaRESUMO
OBJECTIVES: Rasburicase (Fasturtec) is used to prevent or treat hyperuricemia associated with chemotherapy. We developed a capillary zone electrophoresis method to measure urinary allantoin, the degradation product of uric acid by rasburicase. DESIGN AND METHODS: Electrophoresis was performed using a P/ACE 5500 system (Beckman) with a fused silica capillary tube and a UV-visible detector set at 214 nm. Urine samples from 10 patients with non-Hodgkin's lymphoma were analyzed to validate the technique. RESULTS: Using a sodium tetraborate running buffer, urinary allantoin was separated from related compounds and internal standard in less than 30 min. The method was linear up to 1.25 g/L (quantification limit: 30 mg/L); precision was below 10%. The total amount of allantoin excreted in patients treated by rasburicase ranged from 1.5 g to 7.9 g/4 days. CONCLUSION: This CZE assay is a simple, rapid and reproducible method to measure allantoin in urine. Different elimination profiles have been found in patients treated with rasburicase.
Assuntos
Alantoína/urina , Eletroforese Capilar , Proteínas Recombinantes/uso terapêutico , Urato Oxidase/uso terapêutico , Biomarcadores , Humanos , Linfoma não Hodgkin/tratamento farmacológico , Linfoma não Hodgkin/urina , Proteínas Recombinantes/genética , Urato Oxidase/genéticaRESUMO
We previously showed that arsenic trioxide (ATO) and melarsoprol may inhibit the growth of multiple myeloma (MM) cells in vitro and in vivo. We report here the administration of arsenic derivatives in 12 relapsing or refractory secretory MM patients. A total of 10 patients received ATO (eight in a continuous schedule, two discontinuously) and two received melarsoprol. The melarsoprol arm was prematurely closed due to toxicity. In the ATO arm, median duration of treatment was 38 days (9-54). Hepatic toxicity was grade 3 and 2 in one and eight patients, respectively. Other toxicities included neuropathy (n=2, grade 2), encephalitis (n=1, grade 3) and leuconeutropenia (n=4, grade 3). At 2 weeks after treatment initiation, mean serum concentration of arsenic was 1.11+/-0.16 micromol/l. No complete or partial remission was observed. A minor response (25-49% reduction of M protein in serum) and a stabilization of the M-protein level were observed in three and four patients, respectively. After ATO discontinuation, these responses were of short duration in all cases. ATO as a single agent did not produce any significant response in advanced MM patients despite sufficient arsenic exposure. Strategies to improve biodistribution, pharmacokinetic and efficacy of the drug as well as treatment combinations are needed.
Assuntos
Antineoplásicos/uso terapêutico , Arsenicais/uso terapêutico , Mieloma Múltiplo/tratamento farmacológico , Recidiva Local de Neoplasia/tratamento farmacológico , Óxidos/uso terapêutico , Idoso , Antineoplásicos/administração & dosagem , Trióxido de Arsênio , Arsenicais/administração & dosagem , Feminino , Humanos , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Mieloma Múltiplo/sangue , Recidiva Local de Neoplasia/sangue , Óxidos/administração & dosagem , Terapia de SalvaçãoRESUMO
These next years, many anticancer drugs will be available with new mechanism of action. The taxoïd compounds: Taxol and Taxotere have been judged efficous in the treatment of advanced ovary and breast cancers. Also, DNA-Topoisomerase I inhibitors, a new enzyme molecular target, will expand solid tumors therapeutic strategies. The adenosine analogs represent the xnewest advances in hematology: fludarabine becomes the second line treatment for chronic lymphoïd leukemia, cladribine the reference treatment for hairy cell leukemia. At least, all-trans retinoïc acid has changed acute promyelocytic leukemia pronostic by differentiating tumor cells, and open a very new way of cancer treatment. All these agents are the first compounds available, others are still in development. They, all, are benefit of a productive research.