Author:
Ivashkin Vladimir T.,Poluektova Elena A.,Glazunov Alexey B.,Putilovskiy Mikhail A.,Epstein Oleg I.
Abstract
Abstract
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.
Publisher
Springer Science and Business Media LLC
Subject
Gastroenterology,General Medicine
Reference35 articles.
1. Lacy BE, Mearin F, Chang L, Chey W D, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016;150(6):1393–407.e5.
2. Ivashkin VT, Mayev IV, Sheptulin AA, Alekseyeva OP, Baranskaya YK, Ivashkin KV, Kalinin AV, Korochanskaya NV, Kucheryavy YA, Lapina TL, Plotnikova YY, Poluektova YA, Simanenkov VI, Storonova OA, Tkachyov AV, Shifrin OS, Tarasova LV, Khlynov IB. The resolution of advisory council «how to improve treatment results functional dyspepsia and irritable bowel syndrome»? Russ J Gastroenterol Hepatol Coloproctol. 2016;26(2):101–4.
3. Trinkley K, Nahata M. Medication management of irritable bowel syndrome. Digestion. 2014;89(4):253–67.
4. Camilleri M. Medical therapies in the pipeline for irritable bowel syndrome. Gastroenterol Hepatol (N Y). 2017;13(9):550–2.
5. Pimentel M, Cash BD, Lembo A, Wolf RA, Israel RJ, Schoenfeld P. Repeat Rifaximin for irritable bowel syndrome: no clinically significant changes in stool microbial antibiotic sensitivity. Dig Dis Sci. 2017;62(9):2455–63.
Cited by
19 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献