Gut and Liver最新文献

Background/aims: Clinical data on the efficacy and safety of the dual delayed-release formulation of 10-mg esomeprazole (HIP2101) are currently limited. Therefore, this study compared the efficacy and safety of HIP2101 and 20-mg famotidine (RLD2101) in patients with gastric erosions.

Methods: In this multicenter, randomized, double-blind, active-control, phase III study, 326 patients with endoscopically proven gastric mucosal erosion were randomly assigned to receive either HIP2101 or RLD2101 once daily for 2 weeks. The primary endpoint was the rate of improvement of erosion. Secondary endpoints (rate of cure of erosion and edema, and rate of improvement of hematin and gastrointestinal symptoms) and treatment-emergent adverse events were compared between the groups.

Results: Based on the per-protocol set (PPS) analysis, the improvement rates for erosion were 64.9% (98/151) and 63.7% (100/157) in the HIP2101 and RLD2101 groups, respectively (95% confidence interval, -9.5 to 11.9). The lower bound of the 95% confidence interval was greater than the noninferiority margin of -14%. These results were similar to those of the full analysis set (FAS) (HIP2101 group, 64.6%; RLD2101 group, 62.7%). Based on the PPS and FAS analyses, the cure rates for erosion and edema and the improvement rates for hematin and gastrointestinal symptoms were comparable between the groups. The number of adverse events did not differ significantly between the groups.

Conclusions: The efficacy and safety of HIP2101 were comparable to those of RLD2101 in the treatment of gastric erosions and symptomatic improvement. These findings suggest that HIP2101 may be a novel treatment option for gastritis (ClinicalTrials.gov identifier: NCT05024721).

Background/aims: No studies have investigated the effects of radiologic-pathologic discordance on the outcomes of patients who have undergone resection for hepatocellular carcinoma (HCC). Therefore, we investigated the effects of these discrepancies on the outcomes of such patients.

Methods: This study included patients diagnosed with HCC on magnetic resonance imaging who underwent resection, including 1,790 from the Korean Primary Liver Cancer Registry (nationwide cohort) and 185 from Chungnam National University Hospital (hospital cohorts). Radiologic-pathologic discrepancies in five factors (maximum tumor diameter, tumor number, vascular invasion, bile duct invasion, and lymph node metastasis) were evaluated using Kaplan-Meier and Cox regression analyses.

Results: The survival rate in the nationwide cohort was lower when all five factors were discordant than when all were concordant (p<0.001). A similar trend was observed in the hospital cohort; however, it was not statistically significant (p=0.260). In multivariate analyses, radiologicpathologic discrepancies in more than two factors (hazard ratio [HR], 3.251) and vascular invasion (HRs, 2.044 and 2.596), and lymph node metastasis (HRs, 8.157 and 7.209) on pathology or both imaging and pathology, respectively, were independent predictors of survival (all p<0.001). Similarly, lymph node metastasis on imaging emerged as an independent predictor (HR, 3.386; p=0.009). Age, an alpha-fetoprotein ≥200 ng/mL, and a modified Union for International Cancer Control stage were additional independent predictors.

Conclusions: This is the first study to demonstrate that radiologic-pathologic discordance in patients with HCC who have undergone resection are significantly associated with worse survival. More accurate and appropriate preoperative evaluations are essential for optimizing treatment and improving prognosis.

Background/aims: Autoimmune gastritis (AIG) is an immune-mediated chronic atrophic gastritis. This study aimed to investigate the clinical characteristics of AIG patients, stratified by age, sex, and the presence/absence of autoimmune thyroid disease (AITD).

Methods: We reviewed the data of AIG patients treated at a large academic tertiary teaching hospital from January 2018 to October 2023. Patients were grouped according to age (≥60 years or younger), sex, and the presence/absence of AITD and the clinical characteristics of the groups were analyzed.

Results: This study included 183 AIG patients. Older patients (≥60 years) had higher rates of pernicious anemia (26.7% vs 11.8%) and intrinsic factor antibodies (36.8% vs 20.9%) than younger patients (<60 years). However, no significant differences were observed in the extent of gastric atrophy, sex ratio, or serum gastrin levels between the age groups. Female patients were more prone than males to exhibit enterochromaffin-like cell hyperplasia (69.4% vs 39.2%) and had a higher prevalence of iron deficiency anemia (IDA) (25.0% vs 0.0%, p=0.004). AIG patients with AITD were younger (50.9±12.0 years vs 58.0±11.5 years), were more likely to be females (p=0.023), and exhibited milder gastric body atrophy (p=0.009) than those without AITD.

Conclusions: AIG patients demonstrate age- and sex-related differences in clinical characteristics. Older patients are more likely to have intrinsic factor antibody positivity and pernicious anemia, while women are more prone to IDA. There is a high comorbidity rate between AITD and AIG, and patients with AITD-associated AIG are typically younger and tend to have milder gastric body atrophy.

Background/aims: GastroPanel tests include gastrin-17 (G-17) levels in addition to pepsinogen (PG) and Helicobacter pylori serology tests. The aim of this study was to identify significant test findings in patients with gastric neoplasms by comparing the findings of GastroPanel tests and conventional serum PG assays.

Methods: Consecutive individuals who underwent serological testing were included from May 2023 to August 2024. Foreigners and those with gastrectomy, renal insufficiency, previous H. pylori eradication, and recent acid suppressant use were excluded.

Results: Among the 1,101 participants, 122 were diagnosed with gastric neoplasms. High G-17 levels (odds ratio [OR], 1.030; 95% confidence interval [CI], 1.008 to 1.052), low I/II ratios determined by GastroPanel tests (OR, 0.834; 95% CI, 0.779 to 0.894), and low I/II ratios determined by HBI PG assays (OR, 0.584; 95% CI, 0.511 to 0.668) were significant variables for detecting gastric neoplasms. The cutoff values for low I/II ratios were <6.15 (GastroPanel test) and <3.005 (HBI assay), with no differences in diagnostic performance between the two tests (p=0.085). Although the I/II ratio alone was a significant independent variable for detecting early gastric cancers, advanced gastric cancers, adenomas, and neuroendocrine tumors, the G-17 level alone was significant only for adenomas and neuroendocrine tumors. The findings of the patients with gastrointestinal stromal tumors did not differ from those of the controls.

Conclusions: Blood test findings are useful for detecting gastric neoplasms, except for gastrointestinal stromal tumors. The addition of G-17 levels to PG tests is only beneficial for diagnosing gastric neoplasms associated with corpus atrophy, such as adenoma and neuroendocrine tumors (ClinicalTrials.gov identifier NCT05883345).

Metabolic dysfunction-associated steatotic liver disease (MASLD) has emerged as one of the most prevalent chronic liver diseases globally, and its pathogenesis is closely linked to the imbalance of intestinal microbiota and their metabolites. This article reviews the mechanisms through which intestinal microbiota influence the progression of MASLD via the gut-liver axis, elaborating on the complex roles of immune cell hyperactivation, impaired intestinal barrier function, and intestinal microbial metabolites such as short-chain fatty acids and bile acids. The imbalance of intestinal microbiota not only directly promotes the development of MASLD but also further exacerbates disease progression through abnormalities in their metabolites. Various novel therapeutic strategies are being actively developed on the basis of gut-liver axis theory, including probiotic/prebiotic/synbiotic treatment, fecal microbiota transplantation, and targeted drug therapy. These strategies aim to precisely regulate microbial homeostasis and improve glucose and lipid metabolism, thereby alleviating hepatic inflammation and fibrosis and optimizing the therapeutic outcomes of patients with MASLD. In the future, as research progresses, we will further uncover the interaction mechanisms between intestinal microbiota and MASLD and continuously explore more effective treatment methods, with the goal of improving the prognosis and quality of life for MASLD patients.

Background/aims: Findings on the impact of Helicobacter pylori eradication on metabolic parameters are inconsistent. This study aimed to evaluate the effects of H. pylori eradication on metabolic parameters and body composition, including body fat mass and skeletal muscle mass.

Methods: We retrospectively reviewed the data of asymptomatic patients who underwent health screenings, including bioelectrical impedance analysis, before and after H. pylori eradication between 2005 and 2021. After matching individuals based on key factors, we compared lipid profiles, metabolic parameters, and body composition between 823 patients from the eradicated group and 823 patients from the non-eradicated groups.

Results: Blood pressure, erythrocyte sedimentation rate, and glycated hemoglobin values were significantly lower in the eradicated group than in the non-eradicated group. However, changes in body mass index (BMI), body fat mass, appendicular skeletal muscle mass (ASM), waist circumference, and lipid profiles were not significantly different between the two groups. In a subgroup analysis of individuals aged >45 years, blood pressure, erythrocyte sedimentation rate, and glycated hemoglobin changes were significantly lower in the eradicated group than in the non-eradicated group. BMI values were significantly higher in the eradicated group than in the non-eradicated group; however, no significant differences were observed between the two groups regarding changes in body weight, body fat mass, ASM, or waist circumference. Total cholesterol and low-density lipoprotein cholesterol levels were significantly lower in the eradicated group than in non-eradicated group.

Conclusions: H. pylori eradication significantly reduced blood pressure, glucose levels, and systemic inflammation and improved lipid profiles in patients aged >45 years. BMI, body fat mass, ASM, and waist circumference did not significantly differ between patients in the eradicated group and those in the non-eradicated group.

Inflammatory bowel disease (IBD) is characterized by chronic immune-mediated intestinal inflammation, presenting with a spectrum of metabolic disorders as well as intestinal and extraintestinal manifestations. Lifestyle factors, genetic predisposition, immune dysfunction, and gut bacteria composition contribute to the development of IBD. Several comorbidities, including cardiovascular diseases, thrombosis, and metabolic disorders, have been associated with IBD. Therefore, metabolic disorders, including nonalcoholic fatty liver disease, type 2 diabetes mellitus, and obesity have become the focus of attention in patients with IBD. Identifying and managing these conditions can significantly influence patient outcomes and enhance overall management. Therefore, this review aimed to elucidate the current understanding of relevant and emerging metabolic comorbidities and extraintestinal manifestations associated with IBD and their clinical significance.

Background/aims: Infliximab treatment failure in patients with inflammatory bowel disease may result from sub-optimal infliximab trough level. An understanding of pharmacokinetics (PKs) is important to maintain an optimal trough level. PK studies of the switch to subcutaneous (SC) infliximab from intravenous (IV) infliximab using real-world data are lacking. We aimed to develop a population PK model of IV and SC infliximab to predict individual infliximab exposure during maintenance therapy.

Methods: We used data from prospectively collected data on IV and SC infliximab concentrations in patients with inflammatory bowel disease receiving maintenance treatment from February 2020 to December 2022 at Samsung Medical Center. Population PK analysis was conducted by using a two-compartment model with first-order absorption and first-order elimination. Goodness-of-fit plots and visual predictive check were used to evaluate the PK model.

Results: A total of 2,132 samples from 181 patients (149 Crohn's disease and 32 ulcerative colitis) were analyzed. We developed an infliximab population PK model using body mass index, albumin, C-reactive protein level, and the anti-drug antibody level and validated its predictive performance.

Conclusions: It may be possible to predict the infliximab trough level of both IV and SC infliximab in patients with inflammatory bowel disease during maintenance treatment by using our model in real-world practice.

Background/aims: The Korean guidelines for Helicobacter pylori treatment were revised in 2020, however, the extent of adherence to these guidelines in clinical practice remains unclear. Herein, we initiated a prospective, nationwide, multicenter registry study in 2021 to evaluate the current management of H. pylori infection in Korea.

Methods: This interim report describes the adherence to the revised guidelines and their impact on first-line eradication rates. Data on patient demographics, diagnoses, treatments, and eradication outcomes were collected using a web-based electronic case report form.

Results: A total of 7,261 patients from 66 hospitals who received first-line treatment were analyzed. The modified intention-to-treat eradication rate for first-line treatment was 81.0%, with 80.4% of the prescriptions adhering to the revised guidelines. The most commonly prescribed regimen was the 14-day clarithromycin-based triple therapy (CTT; 42.0%), followed by tailored therapy (TT; 21.2%), 7-day CTT (14.1%), and 10-day concomitant therapy (CT; 10.1%). Time-trend analysis demonstrated significant increases in guideline adherence and the use of 10-day CT and TT, along with a decrease in the use of 7-day CTT (all p<0.001). Multivariate logistic regression analysis revealed that guideline adherence was significantly associated with first-line eradication success (odds ratio, 2.03; 95% confidence interval, 1.61 to 2.56; p<0.001).

Conclusions: The revised guidelines for the treatment of H. pylori infection have been increasingly adopted in routine clinical practice in Korea, which may have contributed to improved first-line eradication rates. Notably, the 14-day CTT, 10-day CT, and TT regimens are emerging as the preferred first-line treatment options among Korean physicians.