BACKGROUND AND AIMS: Ontamalimab, a fully-human monoclonal antibody targeting MAdCAM-1, induced remission in patients with moderate-to-severe ulcerative colitis [UC] in the TURANDOT study. We aimed to assess long-term safety, tolerability, and efficacy of ontamalimab in TURANDOT II. METHODS: TURANDOT II was a phase 2, multicentre, open-label [OL] study in patients with moderate-to-severe UC who completed TURANDOT on placebo or ontamalimab (NCT01771809). Patients were randomised to 75 mg or 225 mg ontamalimab every 4 weeks for 72 weeks [OL1]. The dosage could be increased to 225 mg from Week 8 at the investigator's discretion. All patients then received 75 mg every 4 weeks for 72 weeks [OL2], followed by 6-month safety follow-up. The primary objective was safety, measured by adverse events [AEs], serious AEs [SAEs], and AEs leading to withdrawal. Mucosal healing [MH; centrally read endoscopy] was assessed. RESULTS: Of 330 patients, 180 completed OL1; 94 escalated to 225 mg; 127 completed OL2. Overall, 36.1% experienced drug-related AEs. The most common SAE [10.0%] was worsening/ongoing UC; 5.5% of patients had serious infections, the most common being gastroenteritis [0.9%]. One death and four cancers [all unrelated to ontamalimab] occurred. No PML [progressive multifocal leukoencephalopathy]/lymphoproliferative disorders occurred. Geometric mean high-sensitivity C-reactive protein [hsCRP] and faecal calprotectin decreased across OL1 in both dose groups. The proportion of patients assigned to placebo in TURANDOT achieving MH increased from 8.8% [6/68] at baseline to 35.3% at Week 16 [24/68; non-responder imputation]. The corresponding increase in the ontamalimab group was from 23.3% [61/262] to 26.7% [70/262]. CONCLUSIONS: Ontamalimab was well tolerated up to 144 weeks in patients with moderate-to-severe UC, with good safety and efficacy.

• Klíčová slova
• MAdCAM-1, Ulcerative colitis, phase 2,
• MeSH
• C-reaktivní protein analýza   MeSH
• dospělí MeSH
• gastrointestinální endoskopie metody   statistika a číselné údaje   MeSH
• gastrointestinální látky aplikace a dávkování   škodlivé účinky   MeSH
• humanizované monoklonální protilátky * aplikace a dávkování   škodlivé účinky   MeSH
• imunologická odpověď na dávku MeSH
• leukocytární L1-antigenní komplex analýza   MeSH
• lidé MeSH
• molekuly buněčné adheze antagonisté a inhibitory   MeSH
• monitorování léčiv * metody   statistika a číselné údaje   MeSH
• mukoproteiny antagonisté a inhibitory   MeSH
• ulcerózní kolitida * diagnóza   farmakoterapie   imunologie   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• C-reaktivní protein MeSH
• gastrointestinální látky MeSH
• humanizované monoklonální protilátky * MeSH
• leukocytární L1-antigenní komplex MeSH
• MADCAM1 protein, human MeSH Prohlížeč
• molekuly buněčné adheze MeSH
• mukoproteiny MeSH
• ontamalimab MeSH Prohlížeč

BACKGROUND AND AIM: Probe-based confocal laser endomicroscopy (pCLE) provides real-time microscopic visualisation. Our aim was to compare the diagnostic accuracy of pCLE with standard biopsies in patients with visible oesophageal or gastric lesions. METHODS: This was a single-centre, prospective, pathologist-blinded study. Patients underwent high-resolution endoscopy, and lesions were examined by pCLE followed by standard biopsies. A definitive diagnosis was determined from resection specimen. Main outcomes were overall diagnostic accuracy, sensitivity, specificity and positive and negative predictive values. RESULTS: We examined 74 lesions in 67 patients. Definitive diagnoses revealed 34 malignant and 40 non-malignant lesions. pCLE diagnosis was correct in 89.2% (66/74), while diagnosis based on biopsy was correct in 85% (57/67; p = 0.6). The overall diagnostic accuracy of biopsies was 85% (76-94%) and that of pCLE was 89% (79-96%). pCLE correctly diagnosed malignant lesions, comprising oesophageal adenocarcinoma, oesophageal squamous-cell cancer or gastric adenocarcinoma, in 88.2% (30/34) of cases, while biopsy was correctly diagnosed in 75.9% (22/29; p = 0.3). Sensitivity and specificity to diagnose a malignant lesion were 75.9% (95% confidence interval (CI) 56-89%) and 100% (95% CI 90-100%) for biopsies and 88.2% (95% CI 72-97%) and 92% (95% CI 79-98%) for pCLE. No differences between biopsies and pCLE were found with regard to sensitivity, specificity to diagnose dysplastic and benign lesions (p > 0.2). CONCLUSION: pCLE provides satisfactory diagnostic accuracy comparable with standard biopsies in patients with oesophageal or gastric lesions. ClinicalTrials.gov identifier: NCT0292049).

• Klíčová slova
• Confocal laser endomicroscopy, oesophageal and gastric cancer,
• MeSH
• adenokarcinom diagnóza   patologie   MeSH
• biopsie statistika a číselné údaje   MeSH
• dospělí MeSH
• gastrointestinální endoskopie přístrojové vybavení   metody   statistika a číselné údaje   MeSH
• konfokální mikroskopie přístrojové vybavení   metody   statistika a číselné údaje   MeSH
• lasery MeSH
• lidé středního věku MeSH
• lidé MeSH
• nádory jícnu diagnóza   patologie   MeSH
• nádory žaludku diagnóza   patologie   MeSH
• prospektivní studie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• senzitivita a specificita MeSH
• sliznice jícnu diagnostické zobrazování   patologie   MeSH
• spinocelulární karcinom diagnóza   patologie   MeSH
• žaludeční sliznice diagnostické zobrazování   patologie   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky MeSH
• práce podpořená grantem MeSH
• srovnávací studie MeSH

BACKGROUND: Gastrointestinal (GI) disorders account for 10% of all consultations in primary care. Little is known about the management of GI disorders by general practitioners (GP) across different European countries. AIM AND METHODS: We undertook a postal survey of randomly selected samples of GPs in six European countries (UK, Holland, Spain, Greece, Poland, Czech Republic) to determine patterns of diagnosis, management and service use in GI disorders. RESULTS: We received 939 responses, response rate 32%. Over 80% of GPs were aware of at least three national guidelines for gastrointestinal disease. The availability of open access endoscopy ranged from 28% (Poland) to over 80% (Holland, Czech and UK). For uninvestigated dyspepsia the preferred first line management was proton pump inhibitor therapy (33-82%), Helicobacter pylori test and treat (19-47%), early endoscopy (5-32%), specialist referral (2-21%). Regarding irritable bowel syndrome, 23% of respondents were familiar with one or more diagnostic criteria, but between 7% (Netherlands) and 32% (Poland) would ask for a specialist opinion before making the diagnosis. CONCLUSION: The wide variation between GPs both between and within countries partly reflects variations in health care systems but also differing levels of knowledge and awareness, factors which are relevant to educational and research policy.

• MeSH
• dospělí MeSH
• gastrointestinální endoskopie statistika a číselné údaje   MeSH
• gastrointestinální nemoci diagnóza   terapie   MeSH
• inhibitory protonové pumpy terapeutické užití   MeSH
• konziliární vyšetření a konzultace statistika a číselné údaje   MeSH
• lékařská praxe - způsoby provádění statistika a číselné údaje   MeSH
• lidé středního věku MeSH
• lidé MeSH
• průzkumy a dotazníky MeSH
• průzkumy zdravotní péče MeSH
• rodinní lékaři statistika a číselné údaje   MeSH
• směrnice pro lékařskou praxi jako téma MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Evropa MeSH
• Názvy látek
• inhibitory protonové pumpy MeSH

In the retrospective study the author shows the survey of 4,468 gastro and colonofiberscopies performed at the Endoscopic Unit of the Clinic of Surgery in Hradec Králové during the time span 1981-1990. Indications and contraindications, as well as the conditions for performing these endoscopies are being considered. Experiences with the optimum preparation of such patients are also described. Furthermore, the question of the occurrence and importance of gastrointestinal polyps is being discussed. In the second part of this study mainly the problematics of the endoscopical polypectomy is revealed. This set includes 612 patients with polyps in both the upper and lower parts of the gastrointestinal tract. The group of polyps has been divided and studied in greater detail from several points of view, such as their histological character, morphology, localization, clinical symptomatology and others. The endoscopic treatment of polyps is further compared with the alternative way of treatment. The survey of complications is also given. In the discussion and conclusion the follow-up policy, which differs from that of some other authors, is being supported and further ways of diagnosis in this field are outlined, too.

• MeSH
• dospělí MeSH
• gastrointestinální endoskopie * statistika a číselné údaje   MeSH
• gastrointestinální nádory diagnóza   chirurgie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• nádory žaludku diagnóza   chirurgie   MeSH
• polypy střeva diagnóza   chirurgie   MeSH
• polypy diagnóza   chirurgie   MeSH
• retrospektivní studie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH