Triple Therapy-Based on Tegoprazan,a New Potassium-Competitive Acid Blocker,for First-Line Treatment of Helicobacter pylori Infection: A Randomized,Double-Blind,Phase III,Clinical Trial

Background/AimsWe examined the efficacy and safety of tegoprazan as a part of first-line triple therapy for Helicobacter pylori eradication.MethodsA randomized, double-blind, controlled, multicenter study was performed to evaluate whether tegoprazan (50 mg)-based triple therapy (TPZ) was noninferior to lansoprazole (30 mg)-based triple therapy (LPZ) (with amoxicillin 1 g and clarithromycin 500 mg; all administered twice daily for 7 days) for treating H. pylori. The primary endpoint was the H. pylori eradication rate. Subgroup analyses were performed according to the cytochrome P450 (CYP) 2C19 genotype, the minimum inhibitory concentration (MIC) of amoxicillin and clarithromycin, and underlying gastric diseases.ResultsIn total, 350 H. pylori-positive patients were randomly allocated to the TPZ or LPZ group. The H. pylori eradication rates in the TPZ and LPZ groups were 62.86% (110/175) and 60.57% (106/175) in an intention-to-treat analysis and 69.33% (104/150) and 67.33% (101/150) in a per-protocol analysis (non-inferiority test, p=0.009 and p=0.013), respectively. Subgroup analyses according to MICs or CYP2C19 did not show remarkable differences in eradication rate. Both first-line triple therapies were well-tolerated with no notable differences.ConclusionsTPZ is as effective as proton pump inhibitor-based triple therapy and is as safe as first-line H. pylori eradication therapy but does not overcome the clarithromycin resistance of H. pylori in Korea (ClinicalTrials.gov identifier {"type":"clinical-trial","attrs":{"text":"NCT03317223","term_id":"NCT03317223"}}NCT03317223).     

Utility of Direct Peroral Cholangioscopy Using a Multibending Ultraslim Endoscope for Difficult Common Bile Duct Stones

Background/AimsTreatment options for difficult bile duct stones are limited. Direct peroral cholangioscopy (POC)-guided lithotripsy may be an option. A newly developed multibending (MB) ultraslim endoscope has several structural features optimized for direct POC. We evaluated the utility of direct POC using an MB ultraslim endoscope for lithotripsy in patients with difficult bile duct stones.MethodsTwenty patients with difficult bile duct stones, in whom stone removal using conventional endoscopic methods, including mechanical lithotripsy, had failed were enrolled from March 2018 to August 2019. Direct POC-guided lithotripsy was performed by electrohydraulic lithotripsy or laser lithotripsy. The primary outcome was complete ductal clearance, defined as the retrieval of all bile duct stones after lithotripsy confirmed by balloon-occluded cholangiography and/or direct POC.ResultsThe technical success rate of direct POC was 100% (20/20), and the free-hand insertion rate was 95% (19/20). Direct POC-guided lithotripsy, attempted by electrohydraulic lithotripsy in nine patients (45%) and laser lithotripsy in 11 patients (55%), was successful in 95% (19/20) of the patients. Complete ductal clearance after direct POC-guided lithotripsy was achieved in 95% (19/20) of patients. Patients required a median of 2 (range, 1–3) endoscopic retrograde cholangiopancreatography sessions for complete stone removal. Adverse event was observed in one patient (5%) with hemobilia and was treated conservatively.ConclusionsDirect POC using an MB ultraslim endoscope was safe and effective for lithotripsy in patients with difficult bile duct stones.     

Association between metabolic syndrome and left ventricular geometric change including diastolic dysfunction

BackgroundWe investigated the association between individual components of metabolic syndrome (MetS) and left ventricular (LV) geometric changes, including diastolic dysfunction, in a large cohort of healthy individuals.MethodsOverall, 148 461 adults who underwent echocardiography during a health‐screening program were enrolled. Geographic characteristics on echocardiography and several markers of LV relaxation function were identified according to individual MetS components. Univariate linear regression analysis and a multivariate regression model adjusted for factors known to influence LV relaxation function were conducted.ResultsThe prevalence of LV diastolic dysfunction (LVDD) was higher in the MetS group than in the non‐MetS group (0.56% vs. 0.27%, p < .001). In univariate and multivariate analyses, E/A ratio, e′ velocity, and left atrial volume index were significantly associated with each component of MetS and covariates (all p ≤ .001). In the age‐ and sex‐adjusted model, MetS was significantly associated with LVDD (odds ratio [95% confidence interval], 1.350 [1.103, 1.652]). However, subjects with more MetS components did not have a significantly higher risk of LVDD. As the analysis was stratified by sex, the multivariate regression model showed that MetS was significantly associated with LVDD only in men (1.3 [1.00, 1.68]) with higher risk in more MetS component (p for trend < .001). In particular, triglyceride (TG) and waist circumference (WC) among MetS components were significantly associated with LVDD in men.ConclusionsMetS was associated with the risk of LVDD, especially in men, with a dose‐dependent association between an increasing number of components of MetS and LVDD. TG and WC were independent risk factors for LVDD in men.     

Prevalence and comorbidities of bronchiolitis in adults: A population-based study in South Korea

Bronchiolitis generally refers to inflammation and/or fibrosis of the non-cartilaginous small airways located approximately from the 8th airway generation down to the terminal and respiratory bronchioles. In contrast to young children, the frequency of small airway infection in adult bronchiolitis appears less frequent and a number of other pathophysiological conditions have been implicated in adult bronchiolitis. However, little information is available on the exact medical burden of bronchiolitis such as its prevalence and comorbidities in the adult population. The aim of this study is to elucidate the prevalence and comorbidities of bronchiolitis. We used the Korea National Health Insurance Service-National Sample Cohort, which provides data for 1,000,000 individuals out of the entire population by 2% stratified random sampling according to age, sex, residential area, and level of household income. We defined the cause of bronchiolitis other than acute infection as a patient with diagnostic code J448 or J684 and over 20 years of age who visited a clinic or hospital in South Korea. Then, 1:1 propensity score matching was performed to define a non-bronchiolitis (control) group to compare the comorbidities and mortality in the 2 groups. The overall prevalence of bronchiolitis was 688 cases/1,000,000 population during the study period (95% confidence interval, 625–751). The most common comorbid clinical condition in adults with bronchiolitis was rhinitis (52.3%), followed by bronchial asthma (52.23%), hypertension (43.69%), gastroesophageal reflux disease (30.56%), sinusitis (28.72%), diabetes (22.77%), and osteoporosis (17.85%). Other common bronchiolitis-associated comorbidities were cerebrovascular disease (16.86%), angina (14.37%), peripheral vascular disease (13.42%), congestive heart failure (11.9%), and malignancy in any organ (10.6%). Healthcare costs for bronchiolitis increased steeply during the same period. Malignancy in any organ was the leading cause of mortality in the patient group, followed by bronchiolitis itself. Further larger prospective multiethnic cohort studies should be carried out in the near future.     

Immunogenicity and Reactogenicity of Ad26.COV2.S in Korean Adults: A Prospective Cohort Study

BackgroundAs the coronavirus disease 2019 (COVID-19) pandemic continues, there are concerns regarding waning immunity and the emergence of viral variants. The immunogenicity of Ad26.COV2.S against wild-type (WT) and variants of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) needs to be evaluated.MethodThis prospective cohort study was conducted between June 2021 and January 2022 at two university hospitals in South Korea. Healthy adults who were scheduled to be vaccinated with Ad26.COV2.S were enrolled in this study. The main outcomes included anti-spike (S) IgG antibody and neutralizing antibody responses, S-specific T-cell responses (interferon-γ enzyme-linked immunospot assay), solicited adverse events (AEs), and serious AEs.ResultsFifty participants aged ≥ 19 years were included in the study. Geometric mean titers (GMTs) of anti-S IgG were 0.4 U/mL at baseline, 5.2 ± 3.0 U/mL at 3–4 weeks, 55.7 ± 2.4 U/mL at 5–8 weeks, and 81.3 ± 2.5 U/mL at 10–12 weeks after vaccination. GMTs of 50% neutralizing dilution (ND50) against WT SARS-CoV-2 were 164.6 ± 4.6 at 3-4 weeks, 313.9 ± 3.6 at 5–8 weeks, and 124.4 ± 2.6 at 10–12 weeks after vaccination. As for the S-specific T-cell responses, the median number of spot-forming units/10⁶ peripheral blood mononuclear cell was 25.0 (5.0–29.2) at baseline, 60.0 (23.3–178.3) at 5-8 weeks, and 35.0 (13.3–71.7) at 10–12 weeks after vaccination. Compared to WT SARS-CoV-2, ND50 against Delta and Omicron variants was attenuated by 3.6-fold and 8.2-fold, respectively. The most frequent AE was injection site pain (82%), followed by myalgia (80%), fatigue (70%), and fever (50%). Most AEs were grade 1–2, and resolved within two days.ConclusionSingle-dose Ad26.COV2.S was safe and immunogenic. NAb titer and S-specific T-cell immunity peak at 5–8 weeks and rather decrease at 10–12 weeks after vaccination. Cross-reactive neutralizing activity against the Omicron variant was negligible.     

Effects of Wollastonite Fiber and Styrene–Butadiene Latex Polymer on the Long-Term Durability of Cement-Based Repair Materials

Concrete structures are constructed in various geographical environments and climates, and frequently fail to fulfill their original functions over time due to issues such as aging and damage. Research on concrete structure repair materials is being conducted to solve these problems. This study evaluated the durability of a repair material composed of ultra-rapid hardening cement, styrene–butadiene (SB) latex polymer, and wollastonite mineral fiber. The performance targets were as follows: compressive strength of 20 MPa at 1 day of age and 45 MPa at 28 days of age, chloride ion charge passed of less than 1000 Coulombs, carbonation depth of 20 mm or less, and resistance to repeated freezing and thawing (relative dynamic modulus of elasticity) of 80% or more. The ultra-rapid hardening cement:silica sand ratio of 1:1.5 was the experimental variable, and the unit weight of each material in the mix proportion was determined to satisfy the flow requirement of 200 ± 5 mm. This flow ensured sufficient fluidity for spraying, which is the most widely used method for applying repair material. Wollastonite mineral fiber and SB latex polymer were added at 3% and 5% of the unit weight of the binder, respectively. The mechanical property of the repair material was evaluated through compressive strength, and durability was evaluated through chloride ion penetration, alkali resistance, resistance to carbonation, water absorption, and repeated freezing and thawing tests. The compressive strength satisfied both target values, regardless of the addition of SB latex polymer and wollastonite mineral fiber. The chloride ion penetration test, which was used as an indicator of durability, showed that mixtures without SB latex and wollastonite mineral fiber were not satisfied the target charge passed of 1000 Coulombs, while mixtures with latex and mineral fiber reached the target value. Notably, the co-addition of latex and wollastonite fiber showed the highest resistance to chloride ion penetration, alkali ion, carbonation, repeated freezing and thawing, and the least absorption. The results confirmed that the durability of the repair material based on ultra-rapid hardening cement was most effectively improved by the co-addition of SB latex polymer and wollastonite mineral fiber.     

Efficiency and durability of hyaluronic acid of different particle sizes as an injectable material for VF augmentation

Conclusion: The results of the present investigation suggest that modification of HA could improve efficiency and durability in augmentation laryngoplasty. Objectives: Injection laryngoplasty (IL) is one of the most suitable options for treatment of glottic insufficiency, which is caused by vocal fold (VF) paralysis, atrophy, or scarring. Hyaluronic acid (HA) is a widely used material for VF injection. This study was intended to evaluate the durability and efficiency of HA of different particle sizes for VF augmentation. Methods: Three types of HA, Restylane®, monophasic low-viscosity, and unequal particle-sized middle-viscosity HA were injected into the left VF of three groups with eight rabbits each. Results: After 6 and 10 weeks, the injected site was evaluated endoscopically, histologically, radiologically, and functionally. None of the 24 rabbits showed any signs of respiratory distress. Computed tomography (CT) images and endoscopic evaluation revealed sufficient augmented volume of the injected VF in all treated groups 6 weeks after the injection. Histological data at week 10 showed that unequal particle-sized HA did not migrate from its original injection site, while other HAs migrated to the periphery of the arytenoid cartilage. Videokymographic analysis showed more favorable vibrations of unequal particle-sized HA injected VF mucosa 10 weeks post-injection, compared to the other treatment groups.