RESUMO
Background: The purpose of inflammatory bowel disease (IBD) treatment is to achieve resolution of symptoms and remission of disease with a minimum of adverse events (AE). Aim: To report AE of different prescriptions used for the treatment of IBD. Material and Methods: Analysis of a registry of patients with IBD held at a private clinic from 1976 to 2013. All used medications, the occurrence and severity of AE were recorded. Results: The records of 346 patients aged 16 to 86 years, 74% with ulcerative colitis, were analyzed. The most commonly type of medications prescribed were 5-aminosalicylates (5-ASAs) in 329 patients (92%), followed by adrenal steroids in 218 (61%). Forty nine AE were recorded in the same number of patents (14%). These were more common in patients with Crohn disease (n = 19, 21%). An univariate analysis, demonstrated that extra-intestinal manifestations, hospitalizations secondary to IBD crisis, requirement of surgery and treatment with steroids, immunosuppressants or biologic agents were significantly associated with the presence of AE. AEs were more common with immunosuppressants, followed by 5-ASAs and steroids. Discontinuation of therapy was required in 79, 100 and 43% of patients taking these medications, respectively. Twenty percent of AEs were severe. Leukopenia and pancytopenia along with alopecia were the most common AEs attributable to azathioprine. Conclusions: The occurrence of AEs in patients with IBD is uncommon. Even inmunosuppressants or biologic agents have a low rate of AE and most of them mild.
Assuntos
Humanos , Pesquisa Biomédica/organização & administração , Dermatologia/organização & administração , Estudos Multicêntricos como Assunto , Seleção de Pacientes , Ensaios Clínicos Controlados Aleatórios como Assunto , Apoio à Pesquisa como Assunto/organização & administração , Antibacterianos/administração & dosagem , Pesquisa Biomédica/economia , Celulite (Flegmão)/prevenção & controle , Comportamento Cooperativo , Dermatologia/economia , Eczema/prevenção & controle , Reino Unido , Relações Interinstitucionais , Perna (Membro) , Estudos Multicêntricos como Assunto/economia , Objetivos Organizacionais , Avaliação de Programas e Projetos de Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Pesquisadores/economia , Pesquisadores/organização & administração , Abrandamento da ÁguaRESUMO
Societies in Latin America are not scientifically driven and therefore, the allocation of human and economic resources to research is meager, as a reflection of this as well as other cultural and economic realities.
Assuntos
Pesquisa Biomédica/economia , Barreiras de Comunicação , Religião , Medicina Reprodutiva/economia , Apoio à Pesquisa como Assunto/economia , Animais , Pesquisa Biomédica/educação , Pesquisa Biomédica/ética , Escolaridade , Humanos , América Latina , Estudos Multicêntricos como Assunto/economia , Estudos Multicêntricos como Assunto/ética , Medicina Reprodutiva/educação , Medicina Reprodutiva/ética , Apoio à Pesquisa como Assunto/éticaRESUMO
OBJECTIVES: Several methodological problems arise when health outcomes and resource utilization are collected at different sites. To avoid misleading conclusions in multi-center economic evaluations the center effect needs to be taken into adequate consideration. The aim of this article is to compare several models, which make use of a different amount of information about the enrolling center. METHODS: To model the association of total medical costs with the levels of two sets of covariates, one at patient and one at center level, we considered four statistical models, based on the Gamma model in the class of the Generalized Linear Models with a log link, which use different amount of information on the enrolling centers. Models were applied to Cost of Strategies after Myocardial Infarction data, an international randomized trial on costs of uncomplicated acute myocardial infarction (AMI). RESULTS: The simple center effect adjustment based on a single random effect results in a more conservative estimation of the parameters as compared with approaches which make use of deeper information on the centers characteristics. CONCLUSIONS: This study shows, with reference to a real multicenter trial, that center information cannot be neglected and should be collected and inserted in the analysis, better in combination with one or more random effect, taking into account in this way also the heterogeneity among centers because of unobserved centers characteristics.