Background: Improving β-cell function can lead to remission in some patients with type 2 diabetes mellitus (T2DM). However, research on pharmacotherapy-induced remission in youth-onset T2DM remains scarce. Our study aimed to identify the clinical characteristics of pediatric patients who experience remission. Methods: We retrospectively reviewed 88 pediatric patients with T2DM followed for at least 1 year at Seoul National University Bundang Hospital between 2013 and 2023. Remission was defined as a glycosylated hemoglobin (HbA1c) level less than 6.5% for at least 3 months after ceasing glucose-lowering pharmacotherapy. Results: Among 88 patients (60 males, 68.2%) diagnosed at an average age of 14.4±2.1 years, 19 patients (21.6%) achieved remission after a median duration of 1.4 years. The remission group had a larger proportion of males (89.5% vs. 62.3%, P=0.024) and a lower urinary albumin-to-creatinine ratio (ACR) at diagnosis (P=0.011). They also showed lower HbA1c levels at 1 year and more significant changes in HbA1c and body mass index (all P<0.05). Higher urinary ACR levels correlated with a longer duration to achieve remission (hazard ratio, 0.928; P= 0.013). In three of the 19 remission patients (15.8%), recurrence occurred after a median of 1.5 years. Conclusion Among Korean youth with T2DM, 21.6% achieved remission after a median duration of 1.4 years.Those who experienced remission were predominantly male, had lower ACR at diagnosis, and had significant weight loss within the first year. Further investigation into the factors influencing remission and long-term outcomes is essential.

To ensure high-quality bioresources and standardize biobanks, there is an urgent need to develop and disseminate educational training programs in accordance with ISO 20387, which was developed in 2018. The standardization of biobank education programs is also required to train biobank experts. The subdivision of categories and levels of education is necessary for jobs such as operations manager (bank president), quality manager, practitioner, and administrator. Essential training includes programs tailored for beginner, intermediate, and advanced practitioners, along with customized training for operations managers. We reviewed and studied ways to develop an appropriate range of education and training opportunities for standard biobanking education and the training of experts based on KS J ISO 20387. We propose more systematic and professional biobanking training programs in accordance with ISO 20387, in addition to the certification programs of the National Biobank and the Korean Laboratory Accreditation System. We suggest various training programs appropriate to a student’s affiliation or work, such as university biobanking specialized education, short-term job training at unit biobanks, biobank research institute symposiums by the Korean Society of Pathologists, and education programs for biobankers and researchers. Through these various education programs, we expect that Korean biobanks will satisfy global standards, meet the needs of users and researchers, and contribute to the advancement of science.

Background: Epidermal growth factor receptor (EGFR) gene mutation testing is crucial for the administration of tyrosine kinase inhibitors to treat non–small cell lung cancer. In addition to traditional tissue-based tests, liquid biopsies using plasma are increasingly utilized, particularly for detecting T790M mutations. This study compared tissue- and plasma-based EGFR testing methods. Methods: A total of 248 patients were tested for EGFR mutations using tissue and plasma samples from 2018 to 2023 at Pusan National University Yangsan Hospital. Tissue tests were performed using PANAmutyper, and plasma tests were performed using the Cobas EGFR Mutation Test v2. Results: All 248 patients underwent tissue-based EGFR testing, and 245 (98.8%) showed positive results. Of the 408 plasma tests, 237 (58.1%) were positive. For the T790M mutation, tissue biopsies were performed 87 times in 69 patients, and 30 positive cases (38.6%) were detected. Plasma testing for the T790M mutation was conducted 333 times in 207 patients, yielding 62 positive results (18.6%). Of these, 57 (27.5%) were confirmed to have the mutation via plasma testing. Combined tissue and plasma tests for the T790M mutation were positive in nine patients (13.4%), while 17 (25.4%) were positive in tissue only and 12 (17.9%) in plasma only. This mutation was not detected in 28 patients (43.3%). Conclusions Although the tissue- and plasma-based tests showed a sensitivity of 37.3% and 32.8%, respectively, combined testing increased the detection rate to 56.7%. Thus, neither test demonstrated superiority, rather, they were complementary.

Objectives: This study was performed to evaluate the utilization patterns of acid suppressants following the withdrawal of ranitidine in Korea. Methods: Health Insurance Review & Assessment Service (HIRA) data from January 2016 to May 2023 were utilized to assess the usage of histamine H2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs) for acid-related diseases. Drug utilization was calculated for each agent based on the defined daily dose (DDD). To evaluate changes in utilization following the ranitidine recall, an interrupted time series analysis was conducted using segmented linear regression and an autoregressive integrated moving average model. Results: Before the withdrawal of ranitidine, the DDD per 100 000 inhabitants per day was increasing by 6.9 (95% confidence interval [CI], 4.7 to 9.0) for H2RAs and by 19.3 (95% CI, 16.9 to 21.8) for PPIs each month. After the recall, H2RA utilization immediately declined by -1041.7 (95% CI, -1115.8 to -967.7), followed by a monthly increase of 6.6 (95% CI, 3.7 to 9.6) above the previous trend. PPI utilization temporarily surged by 235.2 (95% CI, 149.1 to 321.3), then displayed a monthly increase of 4.1 (95% CI, 0.7 to 7.6) on top of the pre-recall trend. Among PPIs, esomeprazole and rabeprazole demonstrated notable increases, representing the most commonly used acid suppressants in 2023. Conclusions PPI usage rose prominently following the withdrawal of ranitidine from the market. Considering the potential adverse effects of PPIs, further research is necessary to evaluate the public health implications of shifts in the utilization of acid suppressants.

Objective: CT-P13, a biosimilar of infliximab, is widely used for treating ankylosing spondylitis (AS). However, the formation of anti-drug antibodies (ADAs) can reduce its efficacy. This study aimed to identify risk factors associated with high ADA levels in AS patients treated with CT-P13. Methods: A prospective observational study enrolled patients with intravenous CT-P13. Clinical data and disease activity was assessed at baseline, 24 weeks, and 54 weeks after CT-P13 treatment. Blood concentrations of CT-P13 and ADAs were measured at 24 and 54 weeks, and their correlation was investigated. Patients were grouped by ADA levels at 54 weeks. Univariable and multivariable logistic regression identified factors associated with high ADA concentrations. Results: A total of 34 patients was enrolled. Significant decreases in Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores were observed relative to baseline after 24 weeks of CT-P13 therapy. Serum concentrations of CT-P13 and ADA levels increased following treatment. The median serum CT-P13 concentration was 17.6 [12.8, 22.7] µg/mL at 24 weeks and 23.5 [11.7, 34.2] µg/mL at 54 weeks. ADA levels were 6.7 [6.5, 9.1] AU/mL at 24 weeks and 11.4 [9.0, 28.4] AU/mL at 54 weeks. The serum concentrations of CT-P13 and ADA exhibited a negative correlation. In multivariable analysis, current smoking was associated with high ADA production at 54 weeks. Conclusion Smoking is identified as a significant risk factor for elevated ADAs in AS patients treated with CT-P13. The findings underscore the importance of smoking-cessation strategies in the management of AS patients.

Background and Objectives: Pediatric chronic rhinosinusitis (CRS) significantly affects children’s quality of life and learning abilities. This study aimed to evaluate the postoperative outcomes in pediatric patients who underwent functional endoscopic sinus surgery (FESS) for CRS. Methods: A retrospective review was conducted on pediatric patients who underwent FESS for CRS at 11 university hospitals. The inclusion criteria were patients under 20 years old with bilateral disease who were operated on between January 2005 and December 2021. The data collected included demographics, clinical history, blood tests, preoperative computed tomography, and preoperative and postoperative symptom control. The Kruskal-Wallis and Fisher exact tests were used to compare the quantitative and qualitative data, respectively. Results: In total, 213 patients were enrolled. The mean age was 13.4±3.0 years, and 145 (68.1%) were male. One hundred sixty-four patients (77.0%) had nasal polyps and 33 patients (15.5%) underwent revision FESS. The preoperative symptoms, in order of prevalence, included nasal obstruction (87.8%), rhinorrhea (71.8%), a sense of postnasal drip (58.2%), hyposmia (44.6%), cough (24.4%), and facial fullness (18.3%). These symptoms were significantly alleviated for up to 3 years after surgery (p<0.001). At the time of the last follow-up, 121 patients (56.8%) were controlled, 80 (37.6%) were partly controlled, and 12 (5.6%) were uncontrolled. Patients in the uncontrolled group had higher Lund-Mackay scores, longer follow-up durations, and more instances of revision surgery compared to those in the controlled and partly controlled groups. When age was categorized into three groups, those aged 16 years or older tended to have lower Lund-Mackay scores and better control. Conclusion FESS significantly improves both the postoperative symptoms and the long-term quality of life in pediatric CRS patients. Better symptom control is associated with older age and a lower disease burden.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a prevalent condition that significantly impacts quality of life and places a burden on healthcare systems. The advent of biologics targeting type 2 immune pathways offers new therapeutic options for severe and/or uncontrolled CRSwNP. Initially, biologic use was guided by the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) 2020 and the European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA) guidelines, despite limited data on clinical indications, response measures, and treatment duration. Since then, numerous studies and the EPOS/EUFOREA 2023 update have refined these guidelines. The update defines clinical indications for biologics based on type 2 inflammation markers by lowering the blood eosinophil threshold from 250 to 150 cells/μL. The response to biologics is now more simply categorized into three levels based on reductions in nasal polyp size, improvements in quality of life, and enhancement of smell. Treatment evaluation is recommended at 6 months with annual follow-up. Longer administration intervals, such as every four weeks, have also proven effective in well-controlled patients. Although specific guidelines for discontinuation or switching biologics remain lacking, clinical judgment is essential in determining when treatment should be stopped or adjusted. Additionally, regulatory updates support the use of biologics for CRSwNP, and novel agents such as tezepelumab (an anti-thymic stromal lymphopoietin monoclonal antibody) continue to show promise. Finally, in Korea, biologics for CRSwNP are not covered by national health insurance, leading to extended dosing intervals due to high costs. Despite this limitation, studies have shown that adjusted dosing can maintain subjective quality of life. Recent studies by Korean authors have also explored practical considerations such as dosing intervals and comparisons to surgery. Further research is needed to optimize treatment strategies, particularly regarding cost-effectiveness and prospective studies tailored to the Korean healthcare system.

Digital therapeutics (DTx) are emerging as a transformative innovation in healthcare offering evidence-based digital interventions for the treatment, management, and prevention of various diseases and disorders. In Korea, DTx have gained significant attention as potential solutions to the increasing burden of chronic diseases and mental health conditions. However, the Korean DTx market faces several challenges that hinder its widespread adoption and integration into the national healthcare system. This study provides a comprehensive analysis of the current state of the DTx market in Korea, identifies the key challenges impeding its growth, and proposes strategies for overcoming these obstacles. This study utilized a literature review and market analysis approach to examine the latest research, industry reports, and regulatory documents related to DTx. The analysis focused on three primary areas: (1) the current regulatory landscape, (2) technological advancements and challenges, and (3) economic and commercial factors influencing DTx adoption in Korea. A comparative analysis of global regulatory practices was also conducted to identify best practices. The findings revealed that while Korea has made significant strides in supporting DTx development, the market remains in its early stages. The key challenges include underdeveloped regulatory frameworks, issues with data quality and security, and a lack of established reimbursement pathways. We recommend developing tailored regulatory frameworks for DTx, enhancing policy support for small and medium-sized enterprises involved in DTx development, and increasing investments in technological infrastructure. By addressing these challenges, Korea could position itself as a leader in the global DTx market, delivering innovative and effective treatments to enhance patient care and outcomes.

Background and Objectives: Among various emerging catheter-based treatments for severe tricuspid regurgitation (TR), the spacer device can reduce the regurgitation orifice without manipulating the valve leaflet. However, its clinical application has been hampered by traumatic anchoring to the myocardium and the coaxial alignment of the balloon resulting in insufficient TR reduction. This study aimed to evaluate the early-stage safety, technical feasibility, and preliminary efficacy of the novel atraumatic vertical spacer in patients with isolated severe TR. Methods: All procedures were guided by fluoroscopy and transthoracic echocardiography.The maximum device placement time with an inflated balloon was 24 hours. Changes in the amount of TR, right ventricular function, and patient hemodynamics were measured during balloon deployment. Results: A total of 7 patients (median age 74), underwent successful device implantation without procedure-related complications. During balloon inflation (median 25 minutes), there were no symptoms or signs indicative of TR intolerance. TR was reduced by 1 grade or greater in all patients, with 2 patients exhibiting a reduction of 3 grades, from torrential TR to a moderate degree. Mild TR after balloon inflation was achieved in 3 patients with baseline severe TR. The TR reduction observed during initial balloon deployment was sustained during the subsequent balloon maintenance period. Conclusions The Pivot-balloon procedure was safe, technically feasible, and effective in reducing TR in patients with severe TR. No periprocedural complications or adverse cardiovascular events were reported during device placement with TR reduction observed in all patients. However, longer-term follow-up is needed to confirm safety and treatment effect.