RESUMO
PURPOSE: Existing health technology assessment methods can be time-consuming and complicated to use in practice. EValuation of pharmaceutical Innovations with regard to Therapeutic Advantage (EVITA) is a recently developed drug assessment strategy that provides a detailed and clinically relevant evaluation of new agents compared to standard therapies. We therefore sought to use EVITA to evaluate eight novel agents recently introduced to clinical practice or in late-stage trials for the treatment of prostate cancer, metastatic melanoma, or systemic lupus erythematosus (SLE). METHODS: Eight agents (abiraterone, enzalutamide, sipuleucel-T, Prostvac, radium 223, ipilimumab, vemurafenib, and belimumab) were selected for study using the EVITA algorithm. A comprehensive literature search was performed to find clinical trial data, which were then classified using the EVITA protocol. EVITA was also compared to results from health technology assessments (HTAs) or reimbursement decisions. RESULTS: The EVITA scores for the eight drugs ranged from 5.5 to 9: all the selected agents are therefore classed as 'recommended' and are likely to produce a therapeutic advantage. In particular, vemurafenib is likely to be highly beneficial to patients with metastatic melanoma and radium 223 to patients with metastatic prostate cancer affecting the bone. The EVITA results were generally concordant with HTAs. CONCLUSIONS: All the agents show favourable EVITA scores and are therefore recommended for clinical practice. EVITA is an easy-to-use tool that provides clinical context to the assessment of newly introduced agents and can be easily used by non-specialists.
Assuntos
Algoritmos , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Melanoma/tratamento farmacológico , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Neoplasias Cutâneas/tratamento farmacológico , Androstenos , Androstenóis/classificação , Androstenóis/uso terapêutico , Anticorpos Monoclonais/classificação , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais Humanizados/classificação , Anticorpos Monoclonais Humanizados/uso terapêutico , Antineoplásicos/uso terapêutico , Benzamidas , Vacinas Anticâncer/classificação , Vacinas Anticâncer/uso terapêutico , Humanos , Imunossupressores/classificação , Imunossupressores/uso terapêutico , Ipilimumab , Masculino , Melanoma/patologia , Metástase Neoplásica , Nitrilas , Feniltioidantoína/análogos & derivados , Feniltioidantoína/classificação , Feniltioidantoína/uso terapêutico , Radioisótopos/classificação , Radioisótopos/uso terapêutico , Rádio (Elemento)/classificação , Rádio (Elemento)/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias Cutâneas/patologia , Extratos de Tecidos/classificação , Extratos de Tecidos/uso terapêuticoRESUMO
The attention paid to the use of pesticides has increased notably in recent years as demonstrated by the issue of laws and regulations requiring their safe and environmentally-conscious use (e.g. Directive 2009/128/EC and Regulation (EC) no. 1272/2008). Despite the benefits that can be achieved by pursuing the targets of stricter legislative framework, the difficulties for farmers in complying with it are remarkable, especially for small-sized companies. In fact, in contrast to other occupational health and safety (OHS) contexts, in the case of pesticides even a preliminary analysis on the relationship between pesticide use and the consequent exposure risks for the workers is a complex task. In order to reduce the above-mentioned gap, the present study is focused on the development of an easy-to-use tool for carrying out occupational risk assessment of agricultural activities related to the use of pesticides. The procedure was developed by starting from the Agricultural Health Study (AHS) approach and its improvements, and continuing to the thorough development of a tool for preliminary risk assessment, providing a simplified model for its practical application by farmers. A case study concerning olive cultivation was used for its first verification. The results achieved should be considered as an initial step for the promotion of safer practices when using pesticides, providing a consistent base for their further validation.
Assuntos
Exposição Ocupacional/prevenção & controle , Saúde Ocupacional , Praguicidas , Medição de Risco/métodos , Gestão da Segurança/métodos , Agricultura/métodos , Agricultura/normas , Fazendeiros , Humanos , Modelos Teóricos , Exposição Ocupacional/efeitos adversos , Saúde Ocupacional/normas , Olea/crescimento & desenvolvimento , Praguicidas/efeitos adversos , Gestão da Segurança/normasRESUMO
Fosetyl-aluminum is a synthetic fungicide administered to plants especially to prevent diseases caused by the members of the Peronosporales and several Phytophthora species. Herein, we present a selective liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to analyze residues of fosetyl-A1 in air particulate matter. This study was performed in perspective of an exposure assessment of this substance of health concern in environments where high levels of fosetly-Al, relatively to airborne particulate matter, can be found after spraying it. The cleanup procedure of the analyte, from sampled filters of atmospheric particulate matter, was optimized using a Strata X solid-phase extraction cartridge, after accelerated extraction by using water. The chromatographic separation was achieved using a polymeric column based on hydrophilic interaction in step elution with water/acetonitrile, whereas the mass spectrometric detection was performed in negative electrospray ionization. The proposed method resulted to be a simple, fast, and suitable method for confirmation purposes.