1.Safety and efficacy of HK-660S in patients with primary sclerosing cholangitis: A randomized double-blind phase 2a trial
Woo Hyun PAIK ; Joo Kyung PARK ; Moon Jae CHUNG ; Gunn HUH ; Ce Hwan PARK ; Sang Hyub LEE ; Heon Se JEONG ; Hee Jin KIM ; Do Hyun PARK
Clinical and Molecular Hepatology 2025;31(1):119-130
Background/Aims:
A clinical unmet need persists for medications capable of modulating the progression of primary sclerosing cholangitis (PSC). This study aimed to assess the clinical feasibility of HK-660S (beta-lapachone) in PSC.
Methods:
In this multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial, participants were assigned in a 2:1 ratio to receive either 100 mg of HK-660S or a placebo twice daily for 12 weeks. The primary outcomes were the reduction in serum alkaline phosphatase (ALP) levels and the percentage of participants showing improvements in PSC severity, as determined by magnetic resonance cholangiopancreatography with the Anali score. Secondary endpoints included changes in liver stiffness and adverse events.
Results:
The analysis included 21 patients, 15 receiving HK-660S, and six receiving a placebo. Improvements in the Anali score were observed in 13.3% of the HK-660S group, with no improvements in the placebo group. HK-660S treatment resulted in a 15.2% reduction in mean ALP levels, compared to a 6.6% reduction in the placebo group. A stratified ad-hoc analysis based on baseline ALP levels showed a statistically significant response in the HK-660S group among those with ALP levels greater than twice the upper limit of normal, with a 50% responder rate (p=0.05). Additionally, 26.7% of the HK-660S group showed improvements in the enhanced liver fibrosis score, with no improvements in the placebo group. HK-660S was generally well tolerated.
Conclusions
HK-660S is well tolerated among patients with PSC and may improve bile duct strictures, decrease serum ALP levels, and reduce liver fibrosis (cris.nih.go.kr, Number KCT0006590).
2.Comparison between Suture-Button Technique with Syndesmotic Repair and Screw Fixation Technique for Complete Ankle Syndesmotic Injury: Biomechanical Cadaveric Study
Hong Seop LEE ; Sung Hwan KIM ; Ki Won YOUNG ; Woo Jong KIM ; Dong-Il CHEON ; Sung Hun WON ; Sang Heon LEE ; Seung Jin CHOI ; Young Koo LEE
Clinics in Orthopedic Surgery 2025;17(2):324-330
Background:
The tibiofibular syndesmosis is essential for preserving the stability of the ankle. Acute syndesmotic injuries with evident or latent instability usually warrant surgical interventions. This cadaveric study examines and compares biomechanical characteristics between the following treatments for syndesmosis injuries: suture-button fixation plus syndesmotic repair and screw fixation.
Methods:
The lower extremities of 10 cadavers disarticulated at the knee joints were used, yielding 20 feet. Ten feet underwent surgery using the suture-button fixation with syndesmotic repair, while the remaining 10 feet underwent surgery using screw fixation. Before surgical treatment of syndesmosis injuries, each cadaveric lower limb underwent preliminary physiological cyclic loading, which was followed by a series of postfixation cyclic loading tests after the surgical procedure.
Results:
Our principal finding is that suture-button fixation with syndesmotic repair provided torsional strength comparable to that of screw fixation. The mean failure torque did not differ between the 2 groups, but the rotational stiffness was significantly lower in the suture-button fixation/augmentation group.
Conclusions
Suture-button fixation/augmentation facilitates flexible (physiological) syndesmosis movement and may be a useful alternative treatment for ankle syndesmosis injury.
3.Reproducibility of Plasma Biomarker Measurements Across Laboratories:Insights Into ptau217, GFAP, and NfL
Heekyoung KANG ; Sook-Young WOO ; Daeun SHIN ; Sohyun YIM ; Eun Hye LEE ; Hyunchul RYU ; Bora CHU ; Henrik ZETTERBERG ; Kaj BLENNOW ; Jihwan YUN ; Duk L NA ; Hee Jin KIM ; Hyemin JANG ; Jun Pyo KIM ;
Dementia and Neurocognitive Disorders 2025;24(2):91-101
Background:
and Purpose: Plasma biomarkers, including phosphorylated tau (ptau217), glial fibrillary acidic protein (GFAP), and neurofilament light chain (NfL), are promising tools for detecting Alzheimer’s disease (AD) pathology. However, cross-laboratory reproducibility remains a challenge, even when using identical analytical platforms such as single-molecule array (Simoa). This study aimed to compare plasma biomarker measurements (ptau217, GFAP, and NfL) between 2 laboratories, the University of Gothenburg (UGOT) and DNAlink, and evaluate their associations with amyloid positron emission tomography (PET) imaging.
Methods:
Plasma biomarkers were measured using Simoa platforms at both laboratories:the UGOT and DNAlink Incorporation. Diagnostic performance for predicting amyloid PET positivity, cross-laboratory agreement, and the impact of normalization techniques were assessed. Bland-Altman plots and correlation analyses were employed to evaluate agreement and variability.
Results:
Plasma ptau217 concentrations exhibited strong correlations with amyloid PET global centiloid values, with comparable diagnostic performance between laboratories (area under the curve=0.94 for UGOT and 0.95 for DNAlink). Cross-laboratory agreement for ptau217 was excellent (r=0.96), improving further after natural log transformation. GFAP and NfL also demonstrated moderate to strong correlations (r=0.86 for GFAP and r=0.99 for NfL), with normalization reducing variability.
Conclusions
Plasma biomarker measurements were consistent across laboratories using identical Simoa platforms, with strong diagnostic performance and improved agreement after normalization. These findings support the scalability of plasma biomarkers for multicenter studies and underscore their potential for standardized applications in AD research and clinical practice.
4.Clinical Practice Guidelines for Dementia: Recommendations for Cholinesterase Inhibitors and Memantine
Yeshin KIM ; Dong Woo KANG ; Geon Ha KIM ; Ko Woon KIM ; Hee-Jin KIM ; Seunghee NA ; Kee Hyung PARK ; Young Ho PARK ; Gihwan BYEON ; Jeewon SUH ; Joon Hyun SHIN ; YongSoo SHIM ; YoungSoon YANG ; Yoo Hyun UM ; Seong-il OH ; Sheng-Min WANG ; Bora YOON ; Sun Min LEE ; Juyoun LEE ; Jin San LEE ; Jae-Sung LIM ; Young Hee JUNG ; Juhee CHIN ; Hyemin JANG ; Miyoung CHOI ; Yun Jeong HONG ; Hak Young RHEE ; Jae-Won JANG ;
Dementia and Neurocognitive Disorders 2025;24(1):1-23
Background:
and Purpose: This clinical practice guideline provides evidence-based recommendations for treatment of dementia, focusing on cholinesterase inhibitors and N-methyl-D-aspartate (NMDA) receptor antagonists for Alzheimer’s disease (AD) and other types of dementia.
Methods:
Using the Population, Intervention, Comparison, Outcomes (PICO) framework, we developed key clinical questions and conducted systematic literature reviews. A multidisciplinary panel of experts, organized by the Korean Dementia Association, evaluated randomized controlled trials and observational studies. Recommendations were graded for evidence quality and strength using Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology.
Results:
Three main recommendations are presented: (1) For AD, cholinesterase inhibitors (donepezil, rivastigmine, galantamine) are strongly recommended for improving cognition and daily function based on moderate evidence; (2) Cholinesterase inhibitors are conditionally recommended for vascular dementia and Parkinson’s disease dementia, with a strong recommendation for Lewy body dementia; (3) For moderate to severe AD, NMDA receptor antagonist (memantine) is strongly recommended, demonstrating significant cognitive and functional improvements. Both drug classes showed favorable safety profiles with manageable side effects.
Conclusions
This guideline offers standardized, evidence-based pharmacologic recommendations for dementia management, with specific guidance on cholinesterase inhibitors and NMDA receptor antagonists. It aims to support clinical decision-making and improve patient outcomes in dementia care. Further updates will address emerging treatments, including amyloid-targeting therapies, to reflect advances in dementia management.
5.Study Protocol of Expanded Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Microcarcinoma (MAeSTro-EXP)
Jae Hoon MOON ; Eun Kyung LEE ; Wonjae CHA ; Young Jun CHAI ; Sun Wook CHO ; June Young CHOI ; Sung Yong CHOI ; A Jung CHU ; Eun-Jae CHUNG ; Yul HWANGBO ; Woo-Jin JEONG ; Yuh-Seog JUNG ; Kyungsik KIM ; Min Joo KIM ; Su-jin KIM ; Woochul KIM ; Yoo Hyung KIM ; Chang Yoon LEE ; Ji Ye LEE ; Kyu Eun LEE ; Young Ki LEE ; Hunjong LIM ; Do Joon PARK ; Sue K. PARK ; Chang Hwan RYU ; Junsun RYU ; Jungirl SEOK ; Young Shin SONG ; Ka Hee YI ; Hyeong Won YU ; Eleanor WHITE ; Katerina MASTROCOSTAS ; Roderick J. CLIFTON-BLIGH ; Anthony GLOVER ; Matti L. GILD ; Ji-hoon KIM ; Young Joo PARK
Endocrinology and Metabolism 2025;40(2):236-246
Background:
Active surveillance (AS) has emerged as a viable management strategy for low-risk papillary thyroid microcarcinoma (PTMC), following pioneering trials at Kuma Hospital and the Cancer Institute Hospital in Japan. Numerous prospective cohort studies have since validated AS as a management option for low-risk PTMC, leading to its inclusion in thyroid cancer guidelines across various countries. From 2016 to 2020, the Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Microcarcinoma (MAeSTro) enrolled 1,177 patients, providing comprehensive data on PTMC progression, sonographic predictors of progression, quality of life, surgical outcomes, and cost-effectiveness when comparing AS to immediate surgery. The second phase of MAeSTro (MAeSTro-EXP) expands AS to low-risk papillary thyroid carcinoma (PTC) tumors larger than 1 cm, driven by the hypothesis that overall risk assessment outweighs absolute tumor size in surgical decision-making.
Methods:
This protocol aims to address whether limiting AS to tumors smaller than 1 cm may result in unnecessary surgeries for low-risk PTCs detected during their rapid initial growth phase. By expanding the AS criteria to include tumors up to 1.5 cm, while simultaneously refining and standardizing the criteria for risk assessment and disease progression, we aim to minimize overtreatment and maintain rigorous monitoring to improve patient outcomes.
Conclusion
This study will contribute to optimizing AS guidelines and enhance our understanding of the natural course and appropriate management of low-risk PTCs. Additionally, MAeSTro-EXP involves a multinational collaboration between South Korea and Australia. This cross-country study aims to identify cultural and racial differences in the management of low-risk PTC, thereby enriching the global understanding of AS practices and their applicability across diverse populations.
6.Korean Registry on the Current Management of Helicobacter pylori (K-Hp-Reg): Interim Analysis of Adherence to the Revised Evidence-Based Guidelines for First-Line Treatment
Hyo-Joon YANG ; Joon Sung KIM ; Ji Yong AHN ; Ok-Jae LEE ; Gwang Ha KIM ; Chang Seok BANG ; Moo In PARK ; Jae Yong PARK ; Sun Moon KIM ; Su Jin HONG ; Joon Hyun CHO ; Shin Hee KIM ; Hyun Joo SONG ; Jin Woong CHO ; Sam Ryong JEE ; Hyun LIM ; Yong Hwan KWON ; Ju Yup LEE ; Seong Woo JEON ; Seon-Young PARK ; Younghee CHOE ; Moon Kyung JOO ; Dae-Hyun KIM ; Jae Myung PARK ; Beom Jin KIM ; Jong Yeul LEE ; Tae Hoon OH ; Jae Gyu KIM ;
Gut and Liver 2025;19(3):364-375
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 firstline 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.
7.The Incidence of Occult Malignancy in Contralateral Risk Reducing Mastectomy Among Affected Breast Cancer Gene Mutation Carriers in South Korea
Cho Eun LEE ; Dong Seung SHIN ; Ki Jo KIM ; Seok Jin NAM ; Seok Won KIM ; Jonghan YU ; Byung Joo CHAE ; Se Kyung LEE ; Jai Min RYU ; Goo-Hyun MUN ; Jai-Kyong PYON ; Byung-Joon JEON ; Kyongje WOO ; Jeong Eon LEE
Journal of Breast Cancer 2025;28(1):1-10
Purpose:
Breast cancer gene (BRCA) mutation is a well-known risk factor for breast cancer, and clinical interest in prophylactic mastectomy has increased in recent years.We investigated patients who were BRCA mutation carriers and underwent contralateral risk-reducing mastectomy (RRM), focusing on the incidence of occult malignancy after contralateral RRM.
Methods:
Prospectively collected data of patients with breast cancer treated at a single institution were retrospectively reviewed. Patients who underwent RRM with BRCA mutation who underwent RRM between January 2010 and November 2023 were included in this study.Among patients who underwent contralateral RRM, those with a primary cancer diagnosis were included, and those with occult malignancy on the contralateral RRM side were reviewed additionally. The demographics and pathologies of both primary breast cancer and occult malignancies were evaluated.
Results:
In our institution, 925 patients were identified as BRCA mutation carriers, and 320 patients underwent contralateral RRM along with primary breast cancer surgery. BRCA2 mutation occurred more frequently (54.8%) in the overall BRCA mutation cohort. Furthermore, we reviewed 320 patients diagnosed with breast cancer and detected as BRCA mutation carriers who underwent contralateral RRM; high proportion of them were BRCA1 mutation carriers.Interestingly, we found a low incidence of only seven patients (2.2%) with occult malignancy on contralateral RRM side, which is different from that reported in other nations.
Conclusion
The incidence of occult malignancy in the contralateral breast of breast cancer patients with breast cancer with BRCA mutation is significantly low, and may be influenced by several factors. Increased utilization of screening and advancements in diagnostic technologies in South Korea have reduced the chance of occult malignancy in RRM, and a variety of pathologic examination methods may affect the rate of incidence.
8.The effect of a calibrated interproximal brush on proximal plaque removal and periodontal health: a randomized controlled trial
Hye-Jin PARK ; In-Woo CHO ; Hyeon-Seong AHN ; Sung-Jo LEE ; Dae-Young KANG
Journal of Korean Academy of Oral Health 2025;49(1):3-11
Objectives:
To evaluate changes in probing depth, bleeding on probing, and three-dimensional plaque distribution after using an interdental brush for three months.
Methods:
This was a split-mouth design, examiner-blinded, randomized controlled trial. Fifteen patients were randomly assigned to use an interdental brush between their maxillary left or right 1st and 2nd premolar. They were instructed not to use an interdental brush on the opposite side for three months. Probing depth, bleeding on probing, bleeding on using an interdental brush, gingival recession, and plaque distribution were assessed at baseline and after three months.
Results:
After using an interdental brush for three months, 4.26±15.16% of plaque on interdental surfaces decreased. Bleeding on probing and bleeding on using an interdental brush also decreased by 16.67% and 40%, respectively. The size of interdental areas increased by 0.16 mm when using an interdental brush. There were no statistically significant changes in probing depth or gingival recession.
Conclusions
An interdental brush is an effective interdental cleaning aid that reduces interdental plaque and decreases inflammation of interdental soft tissues.
9.Factors Influencing the Mental Well-being of Shift Nurses
Journal of Korean Academy of Psychiatric and Mental Health Nursing 2025;34(1):54-63
Purpose:
The study aimed to provide essential baseline data for developing measures to enhance the mental well-being of shift-working nurses.
Methods:
The data were collected from September 11 to 30, 2024, among 151 shift-working nurses at hospitals nationwide. The collected data were analyzed using descriptive statistics, t-tests, ANOVA, Scheffé tests, Pearson's correlation, and hierarchical multiple regression analysis with IBM SPSS Statistics version 30.0.
Results:
A statistically significant correlation was identified between the primary variables of interest: quality of sleep, health-promoting behaviors, and mental well-being. The findings indicated that poor sleep quality (β=-.32, p<.001) and health-promoting behaviors (β=.55, p<.001) were significant factors affecting the mental well-being of shift-working nurses. The explanatory power of these variables was 56.0%.
Conclusion
This study findings confirmed that the quality of sleep and health-promoting behaviors are related to the mental well-being of shift-working nurses and simultaneously influence it. In other words, to promote the mental health of shift-working nurses, it is essential for nurse managers to focus on managing sleep quality and for an organizational culture that encourages health-promoting activities to be established.
10.Comparative Efficacy of High-Dose Rosuvastatin and Atorvastatin in Preventing Cystatin C-Oriented Contrast-Induced Nephropathy in Patients With Acute Myocardial Infarction: RACCOON-AMI Registry
Ji Hye KIM ; Hyunah KIM ; Seung-Hyuk CHOI ; Woo Jeong CHUN ; Joon Hyung DOH ; Jong-Young LEE ; Seung-Jae LEE ; Byung Jin KIM
Journal of Korean Medical Science 2025;40(14):e50-
Background:
Prevention of contrast-induced nephropathy (CIN) is crucial in acute myocardial infarction (AMI) patients undergoing coronary interventions. Previous studies suggest that high-dose statins may aid in CIN prevention, yet comparative studies among different statin types using cystatin C (cysC) as a biomarker for CIN are absent. This study evaluated the effectiveness of high-dose rosuvastatin versus atorvastatin in preventing cysC-based CIN (cysC-CIN) in AMI patients.
Methods:
This multicenter registry included 431 patients (rosuvastatin 20 mg: n = 231, atorvastatin 40 mg: n = 200). The primary endpoint was cysC-CIN incidence within 48 hours post contrast; the secondary endpoints were creatinine-based CIN (cr-CIN) incidence within 72 hours post contrast and post 30 days adverse events.
Results:
The incidences of cysC-CIN (12.1% vs. 7.5%, P = 0.103) and cr-CIN (6.2% vs. 3.5%, P = 0.103) were higher in the atorvastatin group without significant statistical differences.Multivariable regression analysis, which was adjusted for CIN risk factors and the variables with univariate association, showed no increased odds ratio (OR) (OR, 2.185; 95% confidence interval [CI], 0.899, 5.315; P = 0.085) for cysC-CIN in the atorvastatin group compared to the rosuvastatin group. However, statin-naïve atorvastatin subgroup had significantly increased odds of cysC-CIN compared to the rosuvastatin group (OR, 2.977; 95% CI, 1.057, 8.378; P = 0.039). At post 30 days renal, cardiovascular, and mortality event rates were both low and similar between the two groups.
Conclusion
No significant difference in cysC-CIN incidence was found between the highdose rosuvastatin and atorvastatin groups in AMI patients and cysC was more sensitive to the early detection of CIN than creatinine.

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