Benralizumab efficacy and safety in severe asthma: A randomized trial in Asia.

BACKGROUND: Benralizumab is indicated as add-on therapy in patients with uncontrolled, severe eosinophilic asthma; it has not yet been evaluated in a large Asian population with asthma in a clinical trial. OBJECTIVE: To evaluate the efficacy and safety of benralizumab in patients with severe asthma in Asia. METHODS: MIRACLE (NCT03186209) was a randomized, Phase 3 study in China, South Korea, and the Philippines. Patients aged 12-75 years with severe asthma receiving medium-to-high-dose inhaled corticosteroid/long-acting ß2-agonists, stratified (2:1) by baseline blood eosinophil count (bEOS) (≥300/µL; <300/µL), were randomized (1:1) to benralizumab 30 mg or placebo. Endpoints included annual asthma exacerbation rate (AAER; primary endpoint), change from baseline at Week 48 in pre-bronchodilator (BD) forced expiratory volume in 1 second (pre-BD FEV1) and total asthma symptom score (TASS). Safety was evaluated ≤ Week 56. RESULTS: Of 695 patients randomized, 473 had baseline bEOS ≥300/µL (benralizumab n = 236; placebo n = 237). In this population, benralizumab significantly reduced AAER by 74% (rate ratio 0.26 [95% CI 0.19, 0.36], p < 0.0001) and significantly improved pre-BD FEV1 (least squares difference [LSD] 0.25 L [95% CI 0.17, 0.34], p < 0.0001) and TASS (LSD -0.25 [-0.45, -0.05], p = 0.0126) versus placebo. In patients with baseline bEOS <300/µL, there were numerical improvements in AAER, pre-BD FEV1, and TASS with benralizumab versus placebo. The frequency of adverse events was similar for benralizumab (76%) and placebo (80%) in the overall population. CONCLUSIONS: MIRACLE data reinforces the efficacy and safety of benralizumab for severe eosinophilic asthma in an Asian population, consistent with the global Phase 3 results.

Safety and efficacy of large-bore uncovered stents for treating malignant superior vena cava syndrome.

PURPOSE: To investigate the safety and efficacy of large-bore uncovered stents for treating malignant superior vena cava syndrome. METHODS: This retrospective study included 115 patients (89 men, 26 women; mean age 63.2 years; range 21-83 years) who underwent endovascular large-bore (≥18 mm in diameter) uncovered stent placement between August 2015 and July 2022. One patient was lost to follow-up. Therefore, 114 patients were available for follow-up. RESULTS: Stent placement was technically successful in all 115 patients. Minor procedure-related complications occurred in nine (7.8 %) patients. One hundred eight (93.9 %) patients experienced complete or marked symptomatic relief (Kishi score ≤ 2) at a mean of 3 days after procedure. The cumulative stent patency rates were 98.2 %, 95 %, 93.7 %, 91.5 %, 83.5 %, and 83.5 % at 1, 3, 6, 12, 18, and 24 months, respectively. Stent occlusion occurred in ten (8.8 %) of 114 patients at a mean of 215 days (range 1-732 days) due to thrombosis (n = 7) and tumor ingrowth (n = 3). Stent occlusion did not occur in 21 patients who underwent subsequent central venous catheter insertion. The median patient survival time was 159 days (95 % confidence interval 102-216 days). Univariate and multivariate Cox regression analysis revealed adjuvant anticancer treatment (p = 0.001) and tumor response (p < 0.001) as independent predictors of patient survival. CONCLUSIONS: Endovascular placement of large-bore uncovered stents was a safe and effective treatment for malignant superior vena cava syndrome. Large-bore stent placement can effectively prevent stent occlusion by tumor ingrowth in most cases, and it can provide a sufficient diameter for subsequent insertion of central venous catheters.

Aggregation-induced emission carbon dots as Al3+-mediated nanoaggregate probe for rapid and selective detection of tetracycline.

Worldwide abuse of tetracycline (TC) seriously threatens environmental safety and human health. Metal-TC complexes formed by residual TC in the environment can also contribute to the spread of antibiotic resistance. Therefore, monitoring of TC residues is still required. Here, we report novel aggregation-induced emission carbon dots (AIE-Cdots) as nanoaggregate probes for the rapid and selective detection of TC residue. Riboflavin precursors with rotational functional groups led to the development of AIE-Cdots. The aggregation of AIE-Cdots was induced selectively for Al3+, amplifying the fluorescence signals owing to the restricted rotation of the side chains on the AIE-Cdot surface. The fluorescence signal of such Al3+-mediated nanoaggregates (Al3+-NAs) was further triggered by the structural fixation of TC at the Al3+ active sites, suggesting the formation of TC-coordinated Al3+-NAs. A linear correlation was observed in the TC concentration range of 0-10 µM with a detection limit of 42 nM. In addition, the strong Al3+ binding affinity of AIE-Cdots produced similar NAs and enhanced fluorescence signals in Al3+-TC mixtures. These AIE-Cdots-based nanoplatforms have a rapid response, good selectivity, and reliable accuracy for detecting TC or aluminum complexes, meeting the requirements for hazardous substance monitoring and removal in environmental applications.

Seasonal dynamics response mechanism of benthic microbial community to artificial reef habitats.

Artificial reefs (ARs) have been globally deployed to enhance and restore coastal resource and ecosystems. Microorganisms play an essential role in marine ecosystems, while the knowledge regarding the impact of ARs on microecology is still limited, particularly data concerning the response of benthic microbial community to AR habitats. In this study, the seasonal dynamics of benthic microbial community in AR and adjacent non-artificial reef (NAR) areas surrounding Xiaoshi Island were investigated with high-throughput sequencing technology. The results revealed that the diversity and structure of microbial community between AR and NAR both displayed pronounced seasonal dynamics. There was a greater influence of season factors on microbial communities than that of habitat type. The microbial communities in AR and NAR habitats were characterized by a limited number of abundant taxa (ranging from 5 to 12 ASVs) with high relative abundance (8.35-25.53%) and numerous rare taxa (from 5994 to 12412 ASVs) with low relative abundance (11.91%-24.91%). Proteobacteria, Bacteroidota and Desulfobacterota were the common predominant phyla, with the relative abundances ranging from 50.94% to 76.76%. A total of 52 biomarkers were discovered, with 15, 4, 6, and 27 biomarkers identified in spring, summer, autumn and winter, respectively. Co-occurrence network analysis indicated that AR displayed a more complex interaction pattern and higher susceptibility to external disturbances. Furthermore, the neutral model and ßNTI analyses revealed that the assembly of microbial communities in both AR and NAR is significantly influenced by stochastic processes. This study could provide valuable insights into the impact of ARs construction on the benthic ecosystems and would greatly facilitate the development and implementation of the future AR projects.

The αC-ß4 loop controls the allosteric cooperativity between nucleotide and substrate in the catalytic subunit of protein kinase A.

Allosteric cooperativity between ATP and substrates is a prominent characteristic of the cAMP-dependent catalytic (C) subunit of protein kinase A (PKA). Not only this long-range synergistic action is involved in substrate recognition and fidelity, but it is likely to regulate PKA association with regulatory subunits and other binding partners. To date, a complete understanding of the molecular determinants for this intramolecular mechanism is still lacking. Here, we used an integrated NMR-restrained molecular dynamics simulations and a Markov Model to characterize the free energy landscape and conformational transitions of the catalytic subunit of protein kinase A (PKA-C). We found that the apo-enzyme populates a broad free energy basin featuring a conformational ensemble of the active state of PKA-C (ground state) and other basins with lower populations (excited states). The first excited state corresponds to a previously characterized inactive state of PKA-C with the αC helix swinging outward. The second excited state displays a disrupted hydrophobic packing around the regulatory (R) spine, with a flipped configuration of the F100 and F102 residues at the tip of the αC-ß4 loop. To experimentally validate the second excited state, we mutated F100 into alanine and used NMR spectroscopy to characterize the binding thermodynamics and structural response of ATP and a prototypical peptide substrate. While the activity of PKA-CF100A toward a prototypical peptide substrate is unaltered and the enzyme retains its affinity for ATP and substrate, this mutation rearranges the αC-ß4 loop conformation interrupting the allosteric coupling between nucleotide and substrate. The highly conserved αC-ß4 loop emerges as a pivotal element able to modulate the synergistic binding between nucleotide and substrate and may affect PKA signalosome. These results may explain how insertion mutations within this motif affect drug sensitivity in other homologous kinases.

A common variant rs2054564 in ADAMST17 is associated with susceptibility to lumbar spondylosis.

The molecular pathophysiology underlying lumbar spondylosis development remains unclear. To identify genetic factors associated with lumbar spondylosis, we conducted a genome-wide association study using 83 severe lumbar spondylosis cases and 182 healthy controls and identified 65 candidate disease-associated single nucleotide polymorphisms (SNPs). Replication analysis in 510 case and 911 control subjects from five independent Japanese cohorts identified rs2054564, located in intron 7 of ADAMTS17, as a disease-associated SNP with a genome-wide significance threshold (P = 1.17 × 10-11, odds ratio = 1.92). This association was significant even after adjustment of age, sex, and body mass index (P = 7.52 × 10-11). A replication study in a Korean cohort, including 123 case and 319 control subjects, also verified the significant association of this SNP with severe lumbar spondylosis. Immunohistochemistry revealed that fibrillin-1 (FBN1) and ADAMTS17 were co-expressed in the annulus fibrosus of intervertebral discs (IVDs). ADAMTS17 overexpression in MG63 cells promoted extracellular microfibrils biogenesis, suggesting the potential role of ADAMTS17 in IVD function through interaction with fibrillin fibers. Finally, we provided evidence of FBN1 involvement in IVD function by showing that lumbar IVDs in patients with Marfan syndrome, caused by heterozygous FBN1 gene mutation, were significantly more degenerated. We identified a common SNP variant, located in ADAMTS17, associated with susceptibility to lumbar spondylosis and demonstrated the potential role of the ADAMTS17-fibrillin network in IVDs in lumbar spondylosis development.

A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease

Background/Aims@#Efficacy of proton pump inhibitors is limited in patients with nonerosive reflux disease (NERD). The aim of this study was to comparatively evaluate the efficacy and safety of esomeprazole with sodium bicarbonate and esomeprazole alone. @*Methods@#This was a multicenter, randomized, double-blind, active-controlled, noninferiority comparative study. A total of 379 patients with NERD were randomly allocated to receive either EsoduoⓇ/sup> (esomeprazole 20 mg with sodium bicarbonate 800 mg) or NexiumⓇ/sup> (esomeprazole 20 mg) once daily for 4 weeks from January 2019 to December 2019. The patients had a history of heartburn for at least 2 days in the week before randomization as well as in the last 3 months and no esophageal mucosal breaks on endoscopy. The primary endpoint was a complete cure of heartburn at week 4. The secondary and exploratory endpoints as well as the safety profiles were compared in the groups at weeks 2 and 4. @*Results@#A total of 355 patients completed the study (180 in the EsoduoⓇ/sup> group and 175 in the NexiumⓇ/sup> group). The proportions of patients without heartburn in the entire 4th week of treatment were not different between the two groups (33.33% in the EsoduoⓇ/sup> group and 35% in the NexiumⓇ/sup> group, p=0.737). There were no significant differences in most of the secondary and exploratory endpoints as well as the safety profiles. @*Conclusions@#EsoduoⓇ/sup> is as effective and safe as NexiumⓇ/sup> for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).

Busulfan, Melphalan, and Etoposide (BuME) Showed an Equivalent Effect to Busulfan, Cyclophosphamide, and Etoposide (BuCE) as Conditioning Therapy for Autologous Stem Cell Transplantation in Patients with Relapsed or High-Risk Non-Hodgkin’s Lymphoma: A Multicenter Randomized Phase II Study bythe Consortium for Improving Survival of Lymphoma (CISL) / Journal of the Korean Cancer Association, 대한암학회지

Purpose@#High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) is the standard management for relapsed or high-risk non-Hodgkin’s lymphoma (NHL). We reported the busulfan, melphalan, and etoposide (BuME) conditioning regimen was effective in patients with relapsed or high-risk NHL. Moreover, the busulfan, cyclophosphamide, and etoposide (BuCE) conditioning regimen has been used widely in ASCT for NHL. Therefore, based on these encouraging results, this randomized phase II multicenter trial compared the outcomes of BuME and BuCE as conditioning therapies for ASCT in patients with NHL. @*Materials and Methods@#Patients were randomly assigned to receive either BuME (n=36) or BuCE (n=39). The BuME regimen was comprised of busulfan (3.2 mg/kg/day, intravenously) administered on days –7, –6, and –5, etoposide (400 mg/m2 intravenously) on days –5 and –4, and melphalan (50 mg/m2/day intravenously) on days –3 and –2. The BuCE regimen was comprised of busulfan (3.2 mg/kg/day intravenously) on days –7, –6, and –5, etoposide (400 mg/m2/day intravenously) on days –5 and –4, and cyclophosphamide (50 mg/kg/day intravenously) on days –3 and –2. The primary endpoint was 2-year progression-free survival (PFS). @*Results@#Seventy-five patients were enrolled. Eleven patients (30.5%) in the BuME group and 13 patients (33.3%) in the BuCE group had disease progression or died. The 2-year PFS rate was 65.4% in the BuME group and 60.6% in the BuCE group (p=0.746). There were no non-relapse mortalities within 100 days after transplantation. @*Conclusion@#There were no significant differences in PFS between the two groups. Therefore, busulfan-based conditioning regimens, BuME and BuCE, may be important treatment substitutes for the BCNU-containing regimens.

Comparison of the prevalence and histology between primary benign bladder tumors and recurrent benign lesions after transurethral resection of malignant bladder tumors / 고신대학교의과대학학술지

Background@#Benign bladder tumors are rare disease entities, and insufficient studies have assessed their epidemiological characteristics. The authors investigated the prevalence of benign bladder tumors by retrospectively investigating pathology reports of transurethral resection of bladder tumor (TURBT) procedures over the past 20 years. @*Methods@#We analyzed 1,674 pathology reports of TURBT conducted in 1,160 patients from January 1, 2000, to April 30, 2022. The prevalence of benign tumors and histological classification according to the presence of primary (group 1) and recurrent (group 2) bladder lesions were retrospectively investigated. @*Results@#The mean age of patients was 65.2±11.5 years, and 1,284 cases (79.1%) were in men. Benign bladder tumors comprised 278 cases (248 patients) accounting for about 17.1% of the total TURBT cases (278/1,624). Furthermore, 184 patients (16.0%, 184/1,147) belonged to group 1 and 78 patients (27.4%, 78/285) belonged to group 2. Among all benign lesions that underwent TURBT, cystitis was the most common (41.0%, 114/278), and this rate was higher in group 2 (64/184 [34.8%] vs. 50/94 [53.2%], p<0.001). The prevalence of non-neoplastic lesions was higher in group 1 (44/184 [23.9] vs. 11/94 [11.7%], p<0.001). There was no difference in the prevalence of noninvasive urothelial neoplasms between the two groups (22/184 [12.0%] vs. 8/94 [8.5%], p=0.86). @*Conclusions@#The probability of benign lesions in TURBT was 17.1%, among which cystitis was the most common. When TURBT was performed for recurrent lesions, the frequency of benign tumors was higher than that of primary benign bladder tumors.

Preclinical Evaluation of an Everolimus-Eluting Bioresorbable Vascular Scaffold Via a Long-Term Rabbit Iliac Artery Model

BACKGROUND@#Biodegradable poly (l-lactic acid) (PLLA), a bio safe polymer with a large elastic modulus, is widely used in biodegradable medical devices. However, because of its poor mechanical properties, a PLLA strut must be made twice as thick as a metal strut for adequate blood vessel support. Therefore, the mechanical properties of a drug-eluting metal-based stents (MBS) and a bioresorbable vascular scaffolds (BVS) were evaluated and their safety and efficacy were examined via a long-term rabbit iliac artery model. @*METHODS@#The surface morphologies of the MBSs and BVSs were investigated via optical and scanning electron microscopy. An everolimus-eluting (EE) BVS or an EE-MBS was implanted into rabbit iliac arteries at a 1.1:1 stent-toartery ratio. Twelve months afterward, stented iliac arteries from each group were analyzed via X-ray angiography, optical coherence tomography (OCT), and histopathologic evaluation. @*RESULTS@#Surface morphology analysis of the EE coating on the MBS confirmed that it was uniform and very thin (4.7 lm). Comparison of the mechanical properties of the EE-MBS and EE-BVS showed that the latter outperformed the former in all aspects (radial force (2.75 vs. 0.162 N/mm), foreshortening (0.24% vs. 1.9%), flexibility (0.52 vs. 0.19 N), and recoil (3.2% vs. 6.3%). At all time points, the percent area restenosis was increased in the EE-BVS group compared to the EE-MBS group. The OCT and histopathological analyses indicate no significant changes in strut thickness. @*CONCLUSION@#BVSs with thinner struts and shorter resorption times should be developed. A comparable long-term safety/efficacy evaluation after complete absorption of BVSs should be conducted.

Gastric Mucosa-associated Lymphoid Tissue Lymphoma Mimicking Signet Ring Cell Carcinoma

Gastric mucosa-associated lymphoid tissue (MALT) lymphoma is the most common type of extranodal non-Hodgkin lymphoma. Endoscopic findings are nonspecific and variable; therefore, differentiation of this malignancy from early gastric cancer is challenging during endoscopy. Although an endoscopic biopsy is the gold standard for diagnosis, a biopsy may not conclusively establish the diagnosis in all cases. Diagnostic confirmation requires interpretation of the biopsy specimen findings by an experienced histopathologist, and an additional immunoglobulin heavy chain (IgH) rearrangement test may aid with accurate diagnosis. We present a case of gastric MALT lymphoma that histopathologically mimicked signet ring cell carcinoma (SRCC) on evaluation of repeat endoscopic biopsies. Following endoscopic submucosal dissection (ESD), we confirmed the final diagnosis of gastric MALT lymphoma based on histopathological findings of prominent lymphoid infiltrates accompanied by lymphoepithelial lesions and results of the monoclonal IgH rearrangement test. Notably, a few carcinoma-like signet ring cells (SRCs) in the specimen were attributed to a reactive change. Clinicians should be mindful of possible SRCs in gastric MALT lymphoma specimens to avoid misdiagnosis of SRCC in patients with gastric MALT lymphoma. Confirmatory ESD may be useful for accurate diagnosis and appropriate management of such lesions.

Clinical Application of the Kyoto Classification of Gastritis

Recent advances in endoscopic technology, including high-definition and image-enhanced endoscopy such as narrow-band imaging have facilitated close observation and detailed imaging of the gastric mucosa. Currently, endoscopy is performed in Korea primarily for evaluation of premalignant conditions and gastric cancer detection. Recent research has established the Kyoto classification of gastritis, a novel grading system for endoscopic gastritis, which enables prediction of Helicobacter pylori (H. pylori) infection. The Kyoto classification score is calculated based on the sum of scores for five main items (of 19 endoscopic findings indicative of H. pylori infection) such as atrophy, intestinal metaplasia, enlarged gastric folds, nodularity, and diffuse redness with/without regular arrangement of collecting venules (RAC). Of these five endoscopic findings, atrophy, intestinal metaplasia, enlarged gastric folds, and nodularity are associated with an increased risk and RAC with a decreased risk of gastric cancer. Previous studies have reported that a Kyoto classification score ≥2 indicates current or past H. pylori infection. An increase in the Kyoto classification score is associated with a high risk of gastric cancer; specifically, a Kyoto classification score ≥4 indicates a high risk of gastric cancer. However, H. pylori eradication is followed by disappearance of enlarged gastric folds, nodularity, and diffuse redness; therefore, this grading system cannot accurately reflect the gastric cancer risk in patients with previous H. pylori infection. Limited studies have discussed the Kyoto classification of gastritis in Korea. Therefore, further large-scale multicenter studies are warranted for validation of the Kyoto classification to predict H. pylori infection and gastric cancer risk.

A Gastric Magnetic Foreign Body Incidentally Detected Several Years after Ingestion / 대한소화기학회지

Foreign body ingestion is commonly seen in children. However, occasionally it may also be seen among adults and is often associated with intellectual disability, psychiatric disorders, and alcoholism. Ingestion of a magnetic foreign body may cause complications such as gastrointestinal tract perforation, wherein emergency endoscopic removal of the foreign body is generally required. Here, we report a rare case of a 59-year-old male with an intellectual disability and psychiatric disorder in whom metallic objects in the stomach cavity were accidentally discovered during abdominal CT. Esophagogastroduodenoscopy revealed several metallic objects attached to two magnets, which had been ingested several years before and had remained in the stomach cavity. The magnets and metallic objects were safely removed endoscopically using rat-tooth forceps without complications.

Endoscopic Resection for Gastric Adenocarcinoma of the Fundic Gland Type: A Case Series / 대한소화기학회지

The fundic gland type (GA-FG) of gastric adenocarcinoma is a rare variant of gastric cancer recently included in the 5th edition of the World Health Organization’s classification of digestive system tumors. Five patients with GA-FG underwent an endoscopic resection at our institution. None of the patients had a Helicobacter pylori infection. Four lesions were located in the upper third of the stomach, and one was in the lower third. Three lesions had a IIa shape, while two resembled a subepithelial tumor. An endoscopic submucosal dissection was performed in four patients and endoscopic mucosal resection in one. Tumor cells were composed of well-differentiated columnar cells mimicking fundic gland cells, and the median tumor size was 10 mm. Three lesions exhibited submucosal invasion. No lymphatic or venous invasion was observed. Tumor cells were positive for MUC6 in all five cases; one case was focally positive for MUC5AC. No recurrence was observed during a median follow-up period of 13 months. An endoscopic resection can be a safe treatment modality for GA-FG, considering its small size and low risk of recurrence or metastasis. (Korean J Gastroenterol 2023;81:259-264)

An Esophageal Leiomyoma with Cystic Degeneration Mimicking a Malignant Neoplasm / 이화의대지

Esophageal subepithelial tumors (SETs) are commonly encountered during screening endoscopy, and leiomyomas are the most common SET of the esophagus. Almost all patients with esophageal leiomyomas are asymptomatic; however, some present with dysphagia, depending on the size of the tumor and the extent to which it encroaches on the lumen. The typical endosonographic features of esophageal leiomyomas include well-demarcated, homogeneously hypoechoic lesions with echogenicity similar to that of the surrounding proper muscle layer, but without cystic changes. Histopathologically, esophageal leiomyomas do not undergo cystic or myxoid degeneration. This report presents a case involving a 65-year-old man with a symptomatic esophageal SET and endosonographic features indicative of malignant neoplasms, who was diagnosed with esophageal leiomyoma with cystic and myxoid degeneration following surgical resection.

Human Herpesvirus-8 Positive Multicentric Castleman’s Disease with Complete Response after Rituximab Monotherapy: A Case Report

Castleman’s disease is a rare non-neoplastic lymphoproliferative disorder of unknown origin. It is classified into unicentric or multicentric based on its anatomical distribution. Multicentric Castleman’s disease can be subdivided according to the presence of human herpesvirus-8 (HHV-8) infection. Castleman’s disease has a rare incidence, and HHV-8-positive multicentric Castleman’s disease is even rarer. There are several types of natural course for this disease, and the rapidly progressing type can lead to death within a few weeks, emphasizing the need for prompt diagnosis and treatment. We report a recent case from Korea, presenting with multiple lymphadenopathies, confirmed as HHV-8-positive multicentric Castleman’s disease through biopsy, and achieving complete response with rituximab monotherapy.

Characteristics of Early Onset Dementia and Caring Experiences and Service Needs of Family Caregivers: A Mixed Methods Study / 정신간호학회지

Purpose@#The purpose of this mixed methods study was to explore the caring experiences of the family caregivers of patients with early-onset dementia, and identify the characteristics of early-onset dementia. @*Methods@#A qualitative study was conducted using Colaizzi‘s phenomenological method to explore the caring experiences and service needs of ten family caregivers. A quantitative study was carried out by secondary data analysis to compare the differences in disease characteristics and comorbidities between early and late-onset dementia. @*Results@#The experiences of the family caregivers of patients with early-onset dementia were ‘Learning about dementia’, ‘Away from everyday life’, ‘Facing dementia’, and ‘Barely managing’. The study also revealed that one out of five dementia patients had early-onset dementia. However, most dementia services are concentrated on late-onset dementia. Thus, the family and caregivers of early-onset dementia patients experience relatively inadequate services. @*Conclusion@#This study’s findings identified the characteristics of early-onset dementia, as well as the caring experiences and service needs of family caregivers from a more holistic perspective, and will contribute to the development of adequate nursing intervention programs and policies in the future.

Feasibility of Speech Testing Using Wireless Connection in Single-Sided Cochlear Implant Users

Background and Objectives@#The speech tests used to evaluate language performance in patients with bilateral deafness (BiD) and cochlear implant (CI) are problematic if applied to patients with single-sided deafness (SSD) because normal ear hearing should be excluded. Thus, we investigated the feasibility of using wireless connection to evaluate speech intelligibility of the CI ear in patients with SSD. @*Subjects and Methods@#Patients with BiD and SSD were administered the word recognition scores (WRS) and speech intelligibility tests using an iPadbased wireless connection and conventional methods. To exclude normal side hearing in patients with SSD, masking noise and “plugged and muffed” method were used in the WRS and speech intelligibility tests, respectively. @*Results@#In patients with BiD, the WRS and speech intelligibility tests results using wireless connection and conventional methods were similar. In patients with SSD, the WRS using masking noise in the normal hearing ear was similar to that of using wireless connection. However, 3 of 11 patients with SSD showed under-masked results if using the “plugged and muffed” method. @*Conclusions@#Speech intelligibility testing using wireless connection is a convenient and reliable method for evaluating CI performance in patients with SSD. The “plugged and muffed” method is not recommended for evaluating CI performance in patients with SSD.

Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis

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).

Hemostatic Effect and Mechanism of Epidermal Growth Factor-Hemostatic Powder after Endoscopic Submucosal Dissection in a Porcine Model

Background/Aims@#Among several methods used to prevent endoscopic submucosal dissection (ESD) bleeding, the recently developed hemostatic powder (HP) has few technical limitations and is relatively easy-to-use. This study aimed to analyze the hemostatic effects and mechanisms of two HPs using a porcine upper gastrointestinal hemorrhage model. @*Methods@#We evaluated HPs (Endospray and epidermal growth factor [EGF]-endospray) for adhesion, waterproofing ability, permeability, and absorption in vitro. ESD was performed to induce bleeding ulcers in the porcine stomachs. In a total of three pigs, three bleeding ulcers per animal were generated. Hemostasis and rebleeding were evaluated endoscopically. After 72 hours, the animals were sacrificed, and histologically analyzed. @*Results@#The water absorption of HPs was over 20 times the initial value within 30 minutes. The gelated HPs completely blocked water penetration into the applied site within 5 minutes and strongly adhered to the Petri-dish surface for up to 6 hours. The initial hemostasis rates within 5 minutes were 33.3%, 100.0%, and 66.7%, and the rebleeding rates at 6 to 72 hours after HP application were 33.3%, 16.7%, and 33.3% (control, Endospray, and EGF-endospray groups, respectively). Histological analysis revealed the thickness of the regenerated mucosa (522.1, 514.5, and 680.3 µm) and the submucosal layer (1,510.3, 2,848.2, and 3,062.3 µm) and the number of newly formed blood vessels (15.3, 17.9, and 20.5) in the control, Endospray, and EGFendospray groups, respectively. @*Conclusions@#The endoscopic HPs demonstrated the ability to elicit effective initial hemostasis and the histological ulcer-healing effect of EGF in an animal model of hemorrhagic gastric ulcers.