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BMC Gastroenterol ; 20(1): 2, 2019 Dec 31.
Artigo em Inglês | MEDLINE | ID: mdl-31892312

RESUMO

BACKGROUND: The aim of this study was to investigate the efficacy and safety of the novel complex drug, consisting of released-active form of antibodies to S-100 protein, tumor necrosis factor-α and histamine, (Kolofort) under outpatient conditions in patients with functional dyspepsia (FD), irritable bowel syndrome (IBS), and FD-IBS overlap. METHODS: The subjects of the observational noninterventional retrospective program were the data of 14,362 outpatient records of patients with diagnosed FD, IBS, and/or overlap, who were observed by gastroenterologists from November 01, 2017, through March 30, 2018, who received the drug Kolofort in monotherapy for 12 weeks, 2 tablets twice a day. To assess the presence and severity of symptoms of functional gastrointestinal disorders (FGID), the "7*7" questionnaire developed by a working group from the Russian Gastroenterological Association was used. The evaluated parameters included the proportion of patients: who had a 50% or more reduction in the total score; who have switched to the less severe category of the condition; who have switched to the "healthy" or "borderline ill" severity categories; and the change in the score in domains 1-7. RESULTS: The final efficacy analysis included data from 9254 patients. A decrease in the total score by 50% or more was observed in 80.45% of patients with FD, 79.02% of patients with IBS, and in 83% of patients with both IBS and FD. Switch to a lower severity category of the condition at the end of therapy was noted in 93.35% of patients with FD, in 93.80% of cases in patients with IBS, and in 96.17% of cases in patients with a combination of IBS and FD. A total of 94 adverse events (AEs) were reported in 80 patients (0.65%). CONCLUSION: The COMFORT program has demonstrated the positive effect of treatment in the majority of patients with IBS and FD and their combination in real clinical practice.


Assuntos
Anticorpos/uso terapêutico , Dispepsia/terapia , Histamina/imunologia , Imunoterapia/métodos , Síndrome do Intestino Irritável/terapia , Proteínas S100/imunologia , Fator de Necrose Tumoral alfa/imunologia , Adulto , Assistência Ambulatorial , Anticorpos/efeitos adversos , Combinação de Medicamentos , Dispepsia/complicações , Feminino , Inquéritos Epidemiológicos/instrumentação , Humanos , Imunoterapia/efeitos adversos , Síndrome do Intestino Irritável/complicações , Masculino , Estudos Retrospectivos , Federação Russa , Índice de Gravidade de Doença , Avaliação de Sintomas/métodos , Resultado do Tratamento
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