PMID- 31892312
OWN - NLM
STAT- MEDLINE
DCOM- 20200529
LR  - 20231113
IS  - 1471-230X (Electronic)
IS  - 1471-230X (Linking)
VI  - 20
IP  - 1
DP  - 2019 Dec 31
TI  - Pathogenetic approach to the treatment of functional disorders of the 
      gastrointestinal tract and their intersection: results of the Russian observation 
      retrospective program COMFORT.
PG  - 2
LID - 10.1186/s12876-019-1143-5 [doi]
LID - 2
AB  - 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-alpha 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.
FAU - Ivashkin, Vladimir T
AU  - Ivashkin VT
AD  - I.M. Sechenov First Moscow State Medical University (Sechenov University), 8-2, 
      Trubetskaya St, 119991, Moscow, Russian Federation.
FAU - Poluektova, Elena A
AU  - Poluektova EA
AD  - I.M. Sechenov First Moscow State Medical University (Sechenov University), 8-2, 
      Trubetskaya St, 119991, Moscow, Russian Federation.
FAU - Glazunov, Alexey B
AU  - Glazunov AB
AD  - Department of Medical Information, Research and Production Company Materia Medica 
      Holding LLC "NPF" MATERIA MEDICA HOLDING, 9, 3rd Samotyochny Per, Moscow, Russian 
      Federation, 127473. makarovaea@materiamedica.ru.
FAU - Putilovskiy, Mikhail A
AU  - Putilovskiy MA
AD  - Department of Medical Information, Research and Production Company Materia Medica 
      Holding LLC "NPF" MATERIA MEDICA HOLDING, 9, 3rd Samotyochny Per, Moscow, Russian 
      Federation, 127473.
FAU - Epstein, Oleg I
AU  - Epstein OI
AD  - The Institute of General Pathology and Pathophysiology, 8, Baltiyskaya St, 
      Moscow, Russian Federation, 125315.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20191231
PL  - England
TA  - BMC Gastroenterol
JT  - BMC gastroenterology
JID - 100968547
RN  - 0 (Antibodies)
RN  - 0 (Drug Combinations)
RN  - 0 (S100 Proteins)
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - 820484N8I3 (Histamine)
SB  - IM
MH  - Adult
MH  - Ambulatory Care
MH  - Antibodies/adverse effects/*therapeutic use
MH  - Drug Combinations
MH  - Dyspepsia/complications/*therapy
MH  - Female
MH  - Health Surveys/instrumentation
MH  - Histamine/*immunology
MH  - Humans
MH  - Immunotherapy/adverse effects/*methods
MH  - Irritable Bowel Syndrome/complications/*therapy
MH  - Male
MH  - Retrospective Studies
MH  - Russia
MH  - S100 Proteins/*immunology
MH  - Severity of Illness Index
MH  - Symptom Assessment/methods
MH  - Treatment Outcome
MH  - Tumor Necrosis Factor-alpha/*immunology
PMC - PMC6938622
OTO - NOTNLM
OT  - Functional dyspepsia
OT  - Irritable bowel syndrome
OT  - Overlap of irritable bowel syndrome and functional dyspepsia
OT  - "7*7" questionnaire
COIS- Prof. Glazunov and Dr. Putilovskiy authored this publication as employees of LLC 
      "NPF" MATERIA MEDICA HOLDING". Prof. Epstein is the founder of LLC "NPF "MATERIA 
      MEDICA HOLDING". Kolofort is a preparation manufactured and marketed by LLC "NPF" 
      MATERIA MEDICA HOLDING". The authors report no other conflicts of interest in 
      this work.
EDAT- 2020/01/02 06:00
MHDA- 2020/05/30 06:00
PMCR- 2019/12/31
CRDT- 2020/01/02 06:00
PHST- 2019/07/24 00:00 [received]
PHST- 2019/12/11 00:00 [accepted]
PHST- 2020/01/02 06:00 [entrez]
PHST- 2020/01/02 06:00 [pubmed]
PHST- 2020/05/30 06:00 [medline]
PHST- 2019/12/31 00:00 [pmc-release]
AID - 10.1186/s12876-019-1143-5 [pii]
AID - 1143 [pii]
AID - 10.1186/s12876-019-1143-5 [doi]
PST - epublish
SO  - BMC Gastroenterol. 2019 Dec 31;20(1):2. doi: 10.1186/s12876-019-1143-5.