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OBJECTIVES: Stool characteristics may change depending on the endoscopic activity of ulcerative colitis (UC). We developed a deep learning model using stool photos of patients with UC (DLSUC) to predict endoscopic mucosal inflammation. METHODS: This was a prospective multicenter study conducted in six tertiary referral hospitals. Patients scheduled to undergo endoscopy for mucosal inflammation monitoring were asked to take photos of their stool using smartphones within 1 week before the day of endoscopy. DLSUC was developed using 2161 stool pictures from 306 patients and tested on 1047 stool images from 126 patients. The ulcerative colitis endoscopic index of severity (UCEIS) was used to define endoscopic activity. The performance of DLSUC in endoscopic activity prediction was compared with that of fecal calprotectin (Fcal). RESULTS: The area under the receiver operating characteristic curve (AUC) of DLSUC for predicting endoscopic activity was 0.801 (95% confidence interval [CI] 0.717-0.873), which was not statistically different from the AUC of Fcal (0.837 [95% CI, 0.767-0.899, DeLong's P=0.458]). When rectal sparing cases (23/126, 18.2%) were excluded, the AUC of DLSUC increased to 0.849 (95% CI, 0.760-0.919). The accuracy, sensitivity, and specificity of DLSUC in predicting endoscopic activity were 0.746, 0.662, and 0.877 in all patients and 0.845, 0.745, and 0.958 in patients without rectal sparing, respectively. Active patients classified by DLSUC were more likely to experience disease relapse during a median 8-month follow-up (log-rank test, P=0.002). CONCLUSIONS: DLSUC demonstrated a good discriminating power similar to that of Fcal in predicting endoscopic activity with improved accuracy in patients without rectal sparing. This study implies that stool photos are a useful monitoring tool for typical UC.
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BACKGROUND/AIMS: A poor prognostic factor for Crohn's disease (CD) includes perianal fistulizing disease, including perianal fistula and/or perianal abscess. Currently, a tool to assess perianal symptoms in patients with CD remains nonexistent. This study aimed to develop a perianal fistulizing disease self-screening questionnaire for patients with CD. METHODS: This prospective pilot study was conducted at three tertiary referral centers between January 2019 and May 2020. We formulated questions on perianal symptoms, including tenesmus, anal discharge, bleeding, pain, and heat. A 4-point Likert scale was used to rate each question. Patients with CD completed a questionnaire and underwent pelvic magnetic resonance imaging (MRI). RESULTS: Overall, 93 patients were enrolled, with 51 (54.8%) diagnosed with perianal fistulizing disease, as determined by pelvic MRI. The Spearman correlation findings demonstrated that anal pain (p = 0.450, p < 0.001) and anal discharge (p = 0.556, p < 0.001) were the symptoms that most significantly correlated with perianal disease. For anal pain and discharge, the area under the receiver operating characteristic curve of the scores was significantly higher than that of the combined score for all five symptoms (0.855 vs. 0.794, DeLong's test p = 0.04). For the two symptoms combined, the sensitivity, specificity, and positive predictive and negative predictive values were 88.2, 73.8, 80.4, and 83.8%, respectively, with 81.7% accuracy for detecting perianal fistulizing disease. CONCLUSION: This study indicates that simple questions regarding anal pain and discharge can help accurately identify the presence of perianal fistulizing disease in patients with CD.
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Enfermedad de Crohn , Imagen por Resonancia Magnética , Valor Predictivo de las Pruebas , Fístula Rectal , Humanos , Enfermedad de Crohn/complicaciones , Enfermedad de Crohn/diagnóstico , Masculino , Femenino , Adulto , Fístula Rectal/etiología , Fístula Rectal/diagnóstico por imagen , Fístula Rectal/diagnóstico , Estudios Prospectivos , Proyectos Piloto , Persona de Mediana Edad , Encuestas y Cuestionarios , Adulto Joven , Reproducibilidad de los ResultadosRESUMEN
We aimed to determine whether Crohn's disease (CD) activity patterns assessed via a web-based symptom diary can help predict clinical outcomes in patients with newly diagnosed CD. Patients diagnosed with CD within the preceding 3 months were prospectively enrolled at four tertiary centers. All patients recorded their symptoms on a website using a smartphone at least once a week. The index outcomes were disease-related admission and surgery during follow-up. The disease activity from enrollment to outcome or last follow-up was reviewed for pattern analysis. Cox regression analysis was used to identify the predictors of disease outcomes. A total of 102 patients were enrolled. During a median follow-up period of 42 months, 25 (24.5%) and 6 (5.9%) patients required admission and surgery, respectively. Poor activity pattern was an independent predictor of disease-related hospitalization (adjusted hazard ratio [aHR], 3.96; 95% confidence interval [CI] 1.5-10.45; p = 0.005). A poor activity pattern (aHR, 19.48; 95% CI 1.86-203.95; p = 0.013) and female sex (aHR, 11.28; 95% CI 1.49-85.01; p = 0.018) were found to be independent predictors of bowel resection. CD disease activity patterns monitored through the mobile monitoring system may help predict clinical outcomes, such as disease-related hospitalization and surgery, in patients with newly diagnosed CD.
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Enfermedad de Crohn , Humanos , Enfermedad de Crohn/diagnóstico , Masculino , Femenino , Adulto , Persona de Mediana Edad , Adulto Joven , Estudios Prospectivos , Hospitalización , Teléfono Inteligente , Aplicaciones Móviles , Telemedicina/métodos , Estudios de Seguimiento , AdolescenteRESUMEN
BACKGROUND: Despite the availability of numerous treatment options, many patients with gastritis experience only partial symptom relief. CKD-495, a newly developed product with the active ingredient extracted from Cinnamomum cassia Presl., has demonstrated anti-inflammatory and antioxidant activity in vitro and an in vivo protective effect against gastric damage by stimulating mucus secretion. This study compared the efficacy and safety of CKD-495 with Artemisiae argyi folium (AAF) for the treatment of acute and chronic gastritis. AAF, a gastric mucosa protective agent that promotes gastric mucosa regeneration, has been used clinically for about 20 years. METHODS: This phase III multicenter, randomized, double-blind, parallel-group trial (ClinicalTrials.gov; NCT04255589) assigned 242 patients with endoscopically-proven gastric mucosal erosions to receive CKD-495 75 mg (nâ =â 122) or AAF 60 mg (nâ =â 120), respectively, with placebo (for double-blind purposes) 3 times a day for 2 weeks. The primary efficacy endpoint was the erosion improvement rate. Secondary endpoints included erosion cure rates, and improvement rates for edema, redness, hemorrhage, and gastrointestinal (GI) symptoms. Drug-related adverse events were evaluated. RESULTS: The erosion improvement rate was significantly higher in the CKD-495 group than in the AAF group for both the full analysis set (55.9% vs 39.4%, Pâ =â .0063) and per-protocol set (54.6% vs 38.2%, Pâ =â .0084). In addition, the erosion improvement rate in patients with acute or chronic gastritis showed that the CKD-495 group had better improvement of erosion than the AAF group, especially in patients with chronic gastritis. Analysis of secondary endpoints, which included erosion cure rate and the improvement rates of edema, redness, hemorrhage, and GI symptoms, showed that the CKD-495 group was more effective than the AAF group. There were no significant between-group differences in safety profiles. No serious adverse events or adverse drug reactions occurred. CONCLUSIONS: These results demonstrate that CKD-495 75 mg is superior to AAF 60 mg in terms of the endoscopic improvement rate of erosions in patients with acute or chronic gastritis. This new mucoprotective agent, CKD-495, can be considered the therapy of choice for symptomatic relief and healing of gastritis.
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Gastritis , Insuficiencia Renal Crónica , Humanos , Método Doble Ciego , Edema , Gastritis/tratamiento farmacológico , Gastritis/diagnóstico , Hemorragia , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/tratamiento farmacológico , Resultado del TratamientoRESUMEN
BACKGROUND: Intestinal Behçet's disease (BD) is characterized by typical gastrointestinal ulcers in patients with BD followed by complications such as bleeding, perforation and fistula. Biologic agents are currently under active investigation to delay the disease course. Various data regarding infliximab are available, but there is relatively lack of data regarding adalimumab. METHODS: This was a multicenter, real-world prospective observational study to evaluate the effectiveness and safety of adalimumab in intestinal BD. The primary endpoint was disease activity at each follow up, including disease activity index for intestinal Behçet's disease (DAIBD), serum C-reactive protein (CRP) level, and endoscopic findings. The secondary endpoint was the incidence of adverse drug reactions (ADRs). RESULTS: A total of 58 patients were enrolled and 8 of them were excluded. Adverse events were reported in 72.0% of patients with 122 events. ADRs were reported in 24.0% with 28 events. For adverse events, arthralgia was most commonly reported (13.1%: 16/122) and only one experienced critical adverse event (0.82%, 1/122: death due to stroke). On multivariable regression analysis, a longer disease duration was significantly associated with decreased ADRs [Odds ratio 0.976 (0.953-0.999, 95% CI); p = 0.042]. Clinical response rates as assessed by DAIBD were 90.9% at Week 12 and 89.7% at Week 56, respectively. The mean serum CRP level at baseline was significantly decreased after 12 weeks (3.91 ± 4.93 to 1.26 ± 2.03 mg/dL; p = 0.0002). CONCLUSION: Adalimumab was found to be safe and effective in Korean patients with intestinal BD. A longer disease duration was significantly associated with decreased ADRs.
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Síndrome de Behçet , Enfermedades Intestinales , Humanos , Adalimumab/efectos adversos , Síndrome de Behçet/complicaciones , Síndrome de Behçet/tratamiento farmacológico , Intestinos , Infliximab , Enfermedades Intestinales/tratamiento farmacológico , Enfermedades Intestinales/inducido químicamenteRESUMEN
BACKGROUND/AIMS: Recently, 1 L of polyethylene glycol (PEG) plus ascorbic acid (Asc) has been introduced in Korea as a colonoscopy preparation agent. Data on its efficacy and safety in older adults have been limited. We aimed to evaluate the safety and efficacy of 1 L PEG/Asc in older adults by comparing it with oral sulfate solution (OSS). METHODS: A prospective multicenter randomized study was conducted with subjects aged ≥ 65 years who underwent colonoscopy. The participants were randomized to receive 1 L PEG/Asc or OSS. The primary endpoint was successful bowel preparation, defined as total Boston Bowel Preparation Scale ≥ 6, and ≥ 2 at each segment. Patient satisfaction, adverse events, and renal function changes were compared between the groups. RESULTS: Among the 106 patients, 104 were finally included in the analysis. Overall, successful bowel preparation was achieved in 96.2% of both 1 L PEG/Asc and OSS groups. The satisfaction scores for taste, total amount ingested, overall feeling, and willingness to repeat the same regimen were not significantly different between the groups. Adverse events of moderate or higher severity occurred in 16 and 10 cases in the 1 L PEG/Asc and OSS group, respectively. There were no significant changes in electrolyte levels or renal function from baseline. CONCLUSION: The successful bowel preparation rate was > 90% in both groups without severe adverse effects and significant changes in renal function. As a new low-dose preparation regimen for colonoscopy in older adults, 1 L PEG/Asc, is as effective and safe as OSS.
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Catárticos , Polietilenglicoles , Anciano , Humanos , Polietilenglicoles/efectos adversos , Catárticos/efectos adversos , Sulfatos , Ácido Ascórbico/efectos adversos , Estudios Prospectivos , Método Simple Ciego , ColonoscopíaRESUMEN
BACKGROUND AND AIMS: Perforation is a life-threatening adverse event of colonoscopy that often requires hospitalization and surgery. We aimed to prospectively assess the incidence of colonoscopy-related perforation in a multicenter registry and to analyze the clinical factors associated with poor clinical outcomes. METHODS: This prospective observational study was conducted at six tertiary referral hospitals between 2017 and 2020, and included patients with colonic perforation after colonoscopy. Poor clinical outcomes were defined as mortality, surgery, and prolonged hospitalization (> 13 days). Logistic regression was used to identify factors associated with poor clinical outcomes. RESULTS: Among 84,673 patients undergoing colonoscopy, 56 had colon perforation (0.66/1000, 95% confidence interval [CI] 0.51-0.86). Perforation occurred in 12 of 63,602 diagnostic colonoscopies (0.19/1000, 95% CI 0.11-0.33) and 44 of 21,071 therapeutic colonoscopies (2.09/1000, 95% CI 1.55-2.81). Of these, 15 (26.8%) patients underwent surgery, and 25 (44.6%) patients had a prolonged hospital stay. One patient (1.8%) died after perforation from a diagnostic colonoscopy. In the multivariate analysis, diagnostic colonoscopy (adjusted odds ratio [aOR] 196.43, p = 0.025) and abdominal rebound tenderness (aOR 17.82, p = 0.012) were independent risk factors for surgical treatment. The location of the sigmoid colon (aOR 18.57, p = 0.048), delayed recognition (aOR 187.71, p = 0.008), and abdominal tenderness (aOR 63.20, p = 0.017) were independent risk factors for prolonged hospitalization. CONCLUSIONS: This prospective study demonstrated that the incidence of colonoscopy-related perforation was 0.66/1000. The incidence rate was higher in therapeutic colonoscopy, whereas the risk for undergoing surgery was higher in patients undergoing diagnostic colonoscopy. Colonoscopy indication (diagnostic vs. therapeutic), physical signs, the location of the sigmoid perforation, and delayed recognition were independent risk factors for poor clinical outcomes in colonoscopy-related perforation.
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Enfermedades del Colon , Perforación Intestinal , Humanos , Estudios Prospectivos , Incidencia , Colonoscopía/efectos adversos , Factores de Riesgo , Enfermedades del Colon/epidemiología , Enfermedades del Colon/etiología , Enfermedades del Colon/cirugía , Sistema de Registros , Perforación Intestinal/epidemiología , Perforación Intestinal/etiología , Perforación Intestinal/cirugía , Estudios RetrospectivosRESUMEN
Background/Aims: Fexuprazan is a novel potassium-competitive acid blocker that could be of benefit to patients with gastric mucosal injury. The aim of this study was to assess the 2-week efficacy and safety of fexuprazan in patients with acute or chronic gastritis. Methods: In this study, 327 patients with acute or chronic gastritis who had one or more gastric erosions on endoscopy and subjective symptoms were randomized into three groups receiving fexuprazan 20 mg once a day (q.d.), fexuprazan 10 mg twice a day (b.i.d.), or placebo for 2 weeks. The posttreatment assessments were the primary endpoint (erosion improvement rate), secondary endpoints (cure rates of erosion and edema and improvement rates of redness, hemorrhage, and subjective symptoms), and drug-related adverse events. Results: Among the patients, 57.8% (59/102), 65.7% (67/102), and 40.6% (39/96) showed erosion improvement 2 weeks after receiving fexuprazan 20 mg q.d., fexuprazan 10 mg b.i.d., and placebo, respectively. Both fexuprazan 20 mg q.d. and 10 mg b.i.d. showed superior efficacy to the placebo (p=0.017 and p<0.001, respectively). Likewise, both fexuprazan 20 mg q.d. and 10 mg b.i.d. also showed higher erosion healing rates than the placebo (p=0.033 and p=0.010, respectively). No difference was noted in the edema healing rate and the improvement rates for redness, hemorrhage, and subjective symptoms between the fexuprazan and placebo groups. No significant difference was noted in the incidence of adverse drug reactions. Conclusions: Fexuprazan 20 mg q.d. and 10 mg b.i.d. for 2 weeks showed therapeutic efficacy superior to that of placebo in patients with acute or chronic gastritis (ClinicalTrials.gov identifier NCT04341454).
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Aminas , Gastritis , Humanos , Aminas/uso terapéutico , Gastritis/tratamiento farmacológico , Hemorragia , Edema , Método Doble Ciego , Resultado del TratamientoRESUMEN
Background/Aims: To date, there is no prospective study that specifically investigated the efficacy of infliximab in intestinal Behçet's disease (BD). This study evaluated the efficacy of infliximab in patients with moderate-to-severe active intestinal BD that are refractory to conventional therapies. Methods: This phase 3, interventional, open-label, single-arm study evaluated clinical outcomes of infliximab treatment in patients with moderate-to-severe intestinal BD. The coprimary endpoints were clinical response, decrease in disease activity index for intestinal BD (DAIBD) score ≥20 from weeks 0 to 8 for the induction therapy and week 32 for the maintenance therapy. Results: A total of 33 patients entered the induction therapy and were treated with infliximab 5 mg/kg intravenously at weeks 0, 2, and 6. The mean DAIBD score changed from 90.8±40.1 at week 0 to 40.3±36.4 at week 8, with a significant mean change of 50.5±36.4 (95% confidence interval, 37.5 to 63.4; p<0.001). Thirty-one (93.9%) continued to receive 5 mg/kg infliximab every 8 weeks during the maintenance therapy. The mean change in the DAIBD score after the maintenance therapy was statistically significant (61.5±38.5; 95% confidence interval, 46.0 to 77.1; p<0.001, from weeks 0 to 32). The proportion of patients who maintained a clinical response was 92.3% at week 32. No severe adverse reactions occurred during the induction and maintenance therapies. Conclusions: This study provided evidence that infliximab 5 mg/kg induction and maintenance therapies are efficacious and well-tolerated in patients with moderate-to-severe active intestinal BD. (ClinicalTrials.gov identifier: NCT02505568).
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Síndrome de Behçet , Enfermedades Intestinales , Humanos , Síndrome de Behçet/tratamiento farmacológico , Infliximab/efectos adversos , Enfermedades Intestinales/tratamiento farmacológico , Intestinos , Estudios Prospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Tegoprazan is a novel potassium-competitive acid blocker used to treat acid-related disorders. AIM: To compare tegoprazan 25 mg with lansoprazole 15 mg as maintenance therapy in healed erosive oesophagitis (EE) METHODS: In this phase 3, double-blind, multi-centre study, patients with endoscopically confirmed healed EE were randomised 1:1 to receive tegoprazan 25 mg or lansoprazole 15 mg once daily for up to 24 weeks. The primary efficacy endpoint was the endoscopic remission rate after 24 weeks. The secondary efficacy endpoint was the endoscopic remission rate after 12 weeks. Safety endpoints included adverse events, clinical laboratory results and serum gastrin and pepsinogen I/II levels. RESULTS: We randomised patients to tegoprazan 25 mg (n = 174) or lansoprazole 15 mg (n = 177). Most had mild EE (Los Angeles (LA) grade A: 57.3%, LA grade B: 37.3%). The endoscopic remission rate after 24 weeks was 90.6% with tegoprazan and 89.5% with lansoprazole. Tegoprazan was not inferior to lansoprazole for maintaining endoscopic remission at 24 weeks and 12 weeks. In subgroup analysis, tegoprazan 25 mg showed no significant difference in maintenance rate according to LA grade (p = 0.47). The maintenance effect of tegoprazan was consistent in CYP2C19 extensive metabolisers (p = 0.76). Increases in serum gastrin were not higher in tegoprazan-treated than lansoprazole-treated patients. CONCLUSIONS: Tegoprazan 25 mg was non-inferior to lansoprazole 15 mg in maintenance of healing of mild EE. In this study, tegoprazan had a similar safety profile to lansoprazole.
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Gastrinas , Humanos , Lansoprazol/uso terapéuticoRESUMEN
BACKGROUND: We aimed to compare trough infliximab levels and the development of antidrug antibody (ADA) for 1 year between Crohn's disease (CD) and ulcerative colitis (UC) patients who were biologic-naive, and to evaluate their impact on clinical outcomes. METHODS: This was a prospective, multicenter, observational study. Biologic-naive patients with moderate to severe CD or UC who started CT-P13, an infliximab biosimilar, therapy were enrolled. Trough drug and ADA levels were measured periodically for 1 year after CT-P13 initiation. RESULTS: A total of 267 patients who received CT-P13 treatment were included (CD 168, UC 99). The rates of clinical remission (72% vs. 32.3%, P <0.001) at week 54 were significantly higher in CD than in UC. The median trough drug level (µg/mL) was significantly higher in CD than in UC up to week 14 (week 2, 18.7 vs. 14.7, P <0.001; week 6, 12.5 vs. 8.6, P <0.001; week 14, 3.4 vs. 2.5, P =0.001). The median ADA level (AU/mL) was significantly lower in CD than in UC at week 2 (6.3 vs. 6.5, P =0.046), week 30 (7.9 vs. 11.8, P =0.007), and week 54 (9.3 vs. 12.3, P =0.032). Development of ADA at week 2 [adjusted odds ratio (aOR)=0.15, P =0.026], initial C-reactive protein level (aOR=0.87, P =0.032), and CD over UC (aOR=1.92, P <0.001) were independent predictors of clinical remission at week 54. CONCLUSION: Infliximab shows more favorable pharmacokinetics, including high drug trough and low ADA levels, in CD than in UC, which might result in better clinical outcomes for 1-year infliximab treatment in CD patients.
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Biosimilares Farmacéuticos , Colitis Ulcerosa , Enfermedad de Crohn , Humanos , Colitis Ulcerosa/tratamiento farmacológico , Colitis Ulcerosa/inducido químicamente , Enfermedad de Crohn/tratamiento farmacológico , Infliximab/uso terapéutico , Estudios Prospectivos , Fármacos Gastrointestinales/uso terapéutico , Resultado del Tratamiento , Inducción de Remisión , Biosimilares Farmacéuticos/uso terapéuticoRESUMEN
BACKGROUND: Fexuprazan, a novel potassium-competitive acid blocker, reversibly suppresses the K+/H+-ATPase enzyme in proton pumps within gastric parietal cells. Fexuprazan's suppression of gastric acid was maintained in healthy individuals for 24 h in a dose-dependent manner. AIM: To compare fexuprazan to esomeprazole and establish its efficacy and safety in patients with erosive esophagitis (EE). METHODS: Korean adult patients with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg or esomeprazole 40 mg once daily for eight weeks. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy at week 8. The secondary endpoints included the healing rate of EE at week 4, symptom response, and quality of life assessment. Safety profiles and serum gastrin levels were compared between the groups. RESULTS: Of the 263 randomized, 218 completed the study per protocol (fexuprazan 40 mg, n = 107; esomeprazole 40 mg, n = 111). Fexuprazan was non-inferior to esomeprazole regarding the healing rate at week 8 [99.1% (106/107) vs 99.1% (110/111)]. There were no between-group differences in the EE healing rate at week 4 [90.3% (93/103) vs 88.5% (92/104)], symptom responses, and quality of life assessments. Additionally, serum gastrin levels at weeks 4 and 8 and drug-related side effects did not significantly differ between the groups. CONCLUSION: Fexuprazan 40 mg is non-inferior to esomeprazole 40 mg in EE healing at week 8. We suggest that fexuprazan is an alternative promising treatment option to PPIs for patients with EE.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Esofagitis , Úlcera Péptica , Adulto , Humanos , Esomeprazol/efectos adversos , Gastrinas , Calidad de Vida , ATPasa Intercambiadora de Hidrógeno-PotásioRESUMEN
BACKGROUND AND AIMS: We evaluated the efficacy, safety and tolerability of novel oral sulphate tablets [OSTs] vs 2 L of polyethylene glycol and ascorbate [PEG/Asc] in patients with inflammatory bowel disease [IBD]. PATIENTS AND METHODS: A total of 110 patients with clinically inactive IBD were enrolled in this single-blind multicentre non-inferiority study. Patients were randomly assigned to the OST or 2 L PEG/Asc group and we applied a split-dose regimen. The primary efficacy endpoint was bowel cleansing success rate defined as Harefield Cleansing Scale Grade A or B. The secondary endpoints were perfect preparation rate, the presence of air bubbles, safety as assessed by laboratory abnormalities and self-reported adverse events, or IBD symptom flare-ups. Tolerability was assessed by a pre-procedural visual analog scale [VAS] interview. RESULTS: Both groups showed high cleansing success rates [98.1%] and there was no significant difference in perfect preparation rate. The proportion of a bubble score 0 was significantly higher in the OST group [94.5% vs 50.0%, p < 0.001]. There was no significant intergroup difference in vomiting or bloating. Symptom flare-ups occurred in two OST group patients. No clinically significant blood test abnormalities were noted in either group. Ease of ingestion and taste scores were significantly higher in the OST group. More patients in the OST group [94.5%] wanted to take the same preparation agent for their next colonoscopy. CONCLUSIONS: Both OST and 2 L PEG/Asc demonstrated high successful cleansing and safety in patients with inactive IBD. OST achieved higher satisfaction than 2 L PEG/Asc. Our results suggest that the OST split-dose regimen is effective and safe for patients with inactive IBD.
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Catárticos , Enfermedades Inflamatorias del Intestino , Humanos , Catárticos/efectos adversos , Sulfatos , Método Simple Ciego , Brote de los Síntomas , Colonoscopía/métodos , Polietilenglicoles/efectos adversos , Ácido Ascórbico/efectos adversos , Comprimidos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Enfermedades Inflamatorias del Intestino/inducido químicamenteRESUMEN
Gastric ulcers are one of the most common gastrointestinal diseases. In this study, as an attempt to reduce the minimal error in clinical observations during the diagnosis of gastric ulcers, the applicability of improved ImageJ analysis (IA) was investigated by comparing the results of animal experiments and clinical data. As a result, IA exhibited a significantly improved potential for determining the ulcer index (UI) of clinical data sheets compared to those rated directly by conventional clinical observation (CCO). This indicated that IA enhanced the reproducibility of the measurement of gastric UI using a Bland-Altman plot, resulting in a reduced deviation of each UI value. In addition, it was confirmed that errors in gastric UI decisions can be reduced by adjusting RGB values in diagnostic clinical data (i.e., adjusting to 100 is relatively better than adjusting to 50 or 200). Together, these results suggest that the new enhanced IA could be compatible with novel applications for measuring and evaluating gastric ulcers in clinical settings, meaning that the developed method could be used not only as an auxiliary tool for CCO, but also as a pipeline for ulcer diagnosis.
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BACKGROUND/AIMS: Gastrointestinal bleeding (GIB) risk for non-vitamin K antagonist oral anticoagulants (NOACs) compared with warfarin is largely unknown. We aimed to determine the risk of overall and post-polypectomy GIB for NOACs and warfarin. METHODS: Using the Korean National Health Insurance database, we created a cohort of patients who were newly prescribed NOACs or warfarin between July 2015 and December 2017 using propensity score matching (PSM). Kaplan-Meier analysis with log-rank test was performed to compare the risk of overall and post-polypectomy GIB between NOACs (apixaban, dabigatran, and rivaroxaban) and warfarin. Post-polypectomy GIB was defined as bleeding within 1 month after gastrointestinal endoscopic polypectomy. RESULTS: Out of 234,206 patients taking anticoagulants (187,687 NOACs and 46,519 warfarin), we selected 39,764 pairs of NOACs and warfarin users after PSM. NOACs patients showed significantly lower risk of overall GIB than warfarin patients (log-rank P<0.001, hazard ratio, 0.86; 95% confidence interval, 0.78-0.94; P=0.001). Among NOACs, apixaban showed the lowest risk of GIB. In the subgroup of 7,525 patients who underwent gastrointestinal polypectomy (lower gastrointestinal polypectomy 93.1%), 1,546 pairs were chosen for each group after PSM. The NOACs group showed a high risk of post-polypectomy GIB compared with the warfarin group (log-rank P=0.001, hazard ratio, 1.97; 95% confidence interval, 1.16-3.33; P=0.012). CONCLUSIONS: This nationwide, population-based study demonstrates that risk of overall GIB is lower for NOACs than for warfarin, while risk of post-polypectomy GIB is higher for NOACs than for warfarin.
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BACKGROUND: Colectomy risk after acute severe ulcerative colitis (ASUC) has not been compared between Eastern and Western countries. We compared the 1-year colectomy risk after ASUC between Korea and the USA. METHODS: Data on patients admitted for ASUC to five tertiary referral hospitals in Korea and Mount Sinai Hospital, New York, the USA, between January 2015 and January 2019 were reviewed retrospectively. For comparability between groups, a 1:1 propensity score matching (PSM) was performed. The primary outcome was colectomy, and secondary outcomes were mortality, readmission, and venous thromboembolism (VTE) within 1-year of the index admission for ASUC. The risk of each outcome was compared using Cox proportional hazards model in pre-matched cohort and Kaplan-Meier analysis with log-rank test in post-matched cohort. RESULTS: 290 ASUC patients were included in the study (121 Korea, 169 the USA). After PSM, 56 patients were selected in each group with no significant differences in baseline variables. At 1 year after ASUC, colectomy was less common in Korea than in the USA [3 (5.4%) vs. 24 (42.9%), p < 0.001]. The cumulative colectomy risk was significantly higher in the USA than in Korea in pre-matched cohort [adjusted hazard ratio 7.89, 95% confidence interval 3.23 to 19.22] and in post-matched cohort (log-rank p < 0.001), while there was no difference in cumulative risk of mortality, readmission, and VTE. CONCLUSION: Colectomy risk within 1 year of ASUC is significantly higher in the USA than in Korea. We observed no differences in mortality, readmission, and VTE between the two groups.
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Colitis Ulcerosa , Tromboembolia Venosa , Colectomía/efectos adversos , Colitis Ulcerosa/cirugía , Humanos , Puntaje de Propensión , Estudios Retrospectivos , Tromboembolia Venosa/epidemiologíaRESUMEN
BACKGROUND: The prevalence and risk factors of low bone mineral density (BMD) in Asian patients newly diagnosed with inflammatory bowel disease (IBD) have not been fully suggested. AIMS: We aimed to examine the prevalence and risk factors of low BMD in young Korean patients newly diagnosed with IBD. METHODS: We prospectively enrolled 132 patients aged less than 50 years and newly diagnosed with IBD from six tertiary referral centers in Korea between November 2014 and April 2017. BMD was measured by dual-energy X-ray absorptiometry, and then the Z-score was determined. We defined low BMD as a Z-score ≤ - 1.0. RESULTS: Of 68 patients with ulcerative colitis (UC), 22 (32.4%) had low BMD. Also, of 64 patients with Crohn's disease (CD), 24 (37.5%) showed low BMD. Results from multivariate regression analysis identified the risk factors for low BMD as a high level of alkaline phosphatase (ALP) (≥ 140 U/L) (P = 0.010) in UC patients, and being underweight (body mass index ≤ 18.5 kg/m2) (P = 0.017) in CD patients. CONCLUSIONS: Our study showed that about one-third of newly diagnosed IBD Asian patients had low BMD. The clinical factors associated with low BMD were a high level of ALP in UC patients, and being underweight, in CD patients. Therefore, measurements of BMD in young patients should be considered at the diagnosis of IBD.
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Enfermedades Óseas Metabólicas/diagnóstico por imagen , Enfermedades Óseas Metabólicas/epidemiología , Enfermedades Inflamatorias del Intestino/diagnóstico por imagen , Enfermedades Inflamatorias del Intestino/epidemiología , Absorciometría de Fotón/métodos , Adulto , Densidad Ósea/fisiología , Femenino , Humanos , Masculino , Estudios Prospectivos , República de Corea/epidemiología , Factores de Riesgo , Adulto JovenRESUMEN
BACKGROUND: Oxidative stress has been suggested to be a factor contributing to the disease severity of inflammatory bowel disease (IBD). BJ-1108, a derivative of 6-amino-2,4,5-trimethylpyridin-3-ol, is reported to significantly inhibit the generation of reactive oxygen species (ROS) in vitro. However, whether this molecule affects intestinal inflammation is largely unknown. We aimed to investigate the effect of BJ-1108 on dextran sulfate sodium (DSS)-induced experimental colitis in mice. METHODS: Colitis was induced in mice with DSS, and disease severity was estimated by evaluating body weight, colon length, histology, immune cell infiltration, and intestinal permeability. We examined the protective effects of BJ-1108 on barrier function using Caco-2 cells. Last, we estimated the impact of BJ-1108 on the phosphorylation of NF-kB, PI3K/AKT, and mitogen-activated protein kinases. RESULTS: Mice treated with BJ-1108 exhibited improved disease severity, as indicated by evaluations of body weight, histological scores, spleen weight, and infiltrates of T cells and macrophages. The administration of BJ-1108 inhibited the colonic mRNA expression of IL-6 and IL-1ß in vivo. Additionally, BJ-1108 limited intestinal permeability and enhanced the expression of tight junction (TJ) proteins such as claudin-1 and claudin-3 in the DSS-induced colitis model. In an in vitro model using Caco-2 cells, BJ-1108 ameliorated cytokine-induced ROS generation in a dose-dependent manner and remarkably recovered barrier dysfunction as estimated by evaluating transepithelial electrical resistance and TJ protein expression. BJ-1108 suppressed the NF-kB/ERK/PI3K pathway. CONCLUSIONS: This study demonstrated that BJ-1108 ameliorated intestinal inflammation in an experimental colitis mouse model, suggesting possible therapeutic implications for IBD.
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Aminopiridinas/farmacología , Compuestos de Anilina/farmacología , Colitis , Mucosa Intestinal , Estrés Oxidativo/efectos de los fármacos , Animales , Antioxidantes/farmacología , Células CACO-2 , Colitis/tratamiento farmacológico , Colitis/inmunología , Colitis/metabolismo , Colitis/patología , Citocinas/sangre , Modelos Animales de Enfermedad , Humanos , Mucosa Intestinal/efectos de los fármacos , Mucosa Intestinal/metabolismo , Mucosa Intestinal/patología , Ratones , Permeabilidad/efectos de los fármacos , Sustancias Protectoras/farmacología , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
Background/Aims: Several clinical factors have been used to predict the response for concurrent chemoradiotherapy (CCRT); however, these factors are insufficient for prognostic predictions. We investigated clinical factors to assess whether they could be used to predict the response to CCRT and the survival of patients with esophageal cancer. Methods: Patients with esophageal cancer underwent CCRT from January 2005 to December 2015. Response to CCRT was classified as progressive disease (PD), stationary disease (SD), partial remission (PR), or complete remission (CR). Factors to predict the response to CCRT and patient survival were subsequently investigated. Results: A total of 535 esophageal cancer patients underwent CCRT. Four hundred ninety-three patients were followed up, and patient outcomes were investigated. In the adjusted analysis, patients with advanced stage disease (relative risk [RR], 0.28 in stage III and 0.12 in stage IV compared to stage I), poor performance status, circumferential involvement (RR, 0.61), and male sex (RR, 0.31) were less likely to achieve CR. Advanced stage disease (hazard ratio [HR], 1.71 in stage III/IV), poor CCRT response (HR, 2.82 in PR, 4.47 in SD, 4.77 in PD compared to CR), and poor performance status (HR, 1.38 in ECOG 2-4) were found to increase mortality. Conclusions: Advanced stage disease, poor performance status, male sex, and circumferential involvement were independent predictive factors for a poor response to CCRT. Advanced stage, poor performance status, and poor CCRT response were independent factors for decreased survival.
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Quimioradioterapia , Neoplasias Esofágicas , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias Esofágicas/patología , Neoplasias Esofágicas/terapia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Pronóstico , Modelos de Riesgos ProporcionalesRESUMEN
Objective: Non-invasive stool tests, including the fecal immunochemical test (FIT) and fecal calprotectin (FC), are reliable biomarkers for mucosal healing (MH) in ulcerative colitis (UC). However, which fecal test is superior for predicting MH in inactive UC patients requires evaluation. We aimed to compare the accuracy of FIT and FC results for predicting MH in quiescent UC patients.Methods: This prospective, multicenter study was conducted at three tertiary hospitals. UC patients in clinical remission for at least three months underwent colonoscopy and MH was evaluated using the Mayo endoscopic sub-score (MES). The receiver operating characteristic (ROC) curve and cutoff value with the best accuracy for predicting MH were assessed.Results: Among 127 patients, 65 (51.2%) showed MH (MES = 0). The area under the curve (AUC) for predicting MH (MES = 0) was significantly higher for FC than for FIT (AUC 0.858 (95% confidence interval (CI) 0.784-0.913) vs. 0.707 (95% CI 0.620-0.784), p < .001); there was no difference when MH included MES = 1 (MES ≤ 1) (AUC 0.820 (95% CI 0.742-0.883) vs. 0.813 (95% CI 0.734-0.877), p = .891). When the cutoff value was 70 µg/g for FC and 10 ng/mL for FIT, the sensitivity, specificity, positive predictive value and negative predictive value were 89.2, 71, 76.3, and 86.3, respectively, for FC and 92.3, 50, 65.9, and 86.1, respectively, for FIT.Conclusion: FC is more accurate than FIT for predicting MH in quiescent UC patients. The superiority of FC might be related to the distinctive performance of FC in differentiating inflammatory levels, particularly in low-grade mucosal activity.