The results and findings of studies of preclinical and clinical efficacy and safety of the Company’s medications and their components are published in Russian and international peer-reviewed scientific journals, including those indexed by international bibliographic databases.
Aim - to analyze the modern view on pathogenesis, clinical symptoms and therapy of functional gastrointestinal diseases (FGID) and overlap syndrome. FGID include a number of separate gastrointestinal disorders, characterized by alterations in motility, visceral sensation, and mucus function, that are not associated with structural alterations. The pathogenesis of FGID seems to imply disturbance in brain-gut interactions. The most common functional disorders are irritable bowel syndrome (IBS) and functional dyspepsia (FD). As defined by Rome IV criteria overlap syndrome is one of the modern problem in therapy of FGID. The estimated prevalence of IBS and FD overlap is 42-87%. Since FGID has a huge impact on patient’s psychological condition and the quality of life it is important to treat symptoms of FGID effectively. Symptomatic treatment (antispasmodics, laxative, prokinetics, herbal extracts) has either short-term effect or low impact on patient's improvement. Thus pathogenetic therapy should be the therapy of choice for FGID and overlap syndrome treatment. The aim of FGID therapy is to reduce symptoms effectively, to avoid the symptom recurrence and overlap syndrome. Kolofort with pathogenetic action is safe and effective in FGID treatment and provide high level of patient’s compliance.
Irritable bowel syndrome (IBS) is a widespread functional disorder which is characterized by regularly repeated pains or discomfort in the abdominal area along with violation of the bowel without identifiable organic causes. Recently it has been shown, the trigger in IBS appearance turns out to be stress causing the emergence of excessive emotions. Under stressful conditions neuropeptides (substance P) activation occurs and contributes the inflammatory changes appearance of the mucous membrane of the colon with minimum character. Continuing attempts to produce the effective therapy scheme of IBS with prolonged action didn’t show the results in any current of disease. Due to the results, problem of search and unbiased assessment of a medication faces difficulties in the complication and the poor knowledge of IBS pathophysiology and high level of placebo effect in the group of patients. A new approach in IBS therapy is the use of medicine Kolofort, made by Materia Medika Holding company on the basis of antibodies to human factor in tumour necrosis α (anti-FTN- α), brain specific protein S-100 (anti-S100) and histamine (anti-H). Combination of the three active components allows to affect central and peripheral links in pathogenesis of bowel functional violations, including visceral hypersensitivity, facilitates the reduction of abdominal severity of pain syndrome and recovery of gastrointestinal tract motility. Preclinical and clinical research, made earlier, showed the effectiveness and safety of Kolofort and its components in treatment of gastrointestinal pathology of inflammatory and functional genesis, along with the cupping of somatoform disfunctions and psychoneurological disorders on the background of somatic and neurologic diseases. Many specialists are interested in the results of multicentre randomized clinical research, made with aim to show the clinical effectiveness and safety of Kolofort when treating patients with IBS under conditions of blind placebo-control.
The article describes preclinical and clinical trial results (focusing on experimental data), that demonstrate broad spectrum of specific pharmacological activity and safety as well as mechanism of action for tumor necrosis factor α antibodies in release active form (RA anti-TNFα).