1.Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
Nam Hoon KIM ; Juneyoung LEE ; Suk CHON ; Jae Myung YU ; In-Kyung JEONG ; Soo LIM ; Won Jun KIM ; Keeho SONG ; Ho Chan CHO ; Hea Min YU ; Kyoung-Ah KIM ; Sang Soo KIM ; Soon Hee LEE ; Chong Hwa KIM ; Soo Heon KWAK ; Yong‐ho LEE ; Choon Hee CHUNG ; Sihoon LEE ; Heung Yong JIN ; Jae Hyuk LEE ; Gwanpyo KOH ; Sang-Yong KIM ; Jaetaek KIM ; Ju Hee LEE ; Tae Nyun KIM ; Hyun Jeong JEON ; Ji Hyun LEE ; Jae-Han JEON ; Hye Jin YOO ; Hee Kyung KIM ; Hyeong-Kyu PARK ; Il Seong NAM-GOONG ; Seongbin HONG ; Chul Woo AHN ; Ji Hee YU ; Jong Heon PARK ; Keun-Gyu PARK ; Chan Ho PARK ; Kyong Hye JOUNG ; Ohk-Hyun RYU ; Keun Yong PARK ; Eun-Gyoung HONG ; Bong-Soo CHA ; Kyu Chang WON ; Yoon-Sok CHUNG ; Sin Gon KIM
Endocrinology and Metabolism 2024;39(5):722-731
Background:
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods:
This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion
This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
2.Clinical Experience of Allogeneic Hematopoietic Stem Cell Transplantation in Elderly Patients Aged 60 Years and Older in South Korea
Young Sok JI ; Jae-Sook AHN ; Jina YUN ; Geum Ha JANG ; Sung Hee LIM ; Se Hyung KIM ; Chan Kyu KIM ; Jong Ho WON ; Seong Kyu PARK
Yonsei Medical Journal 2023;64(2):123-132
Purpose:
The purpose of this study is to share our outcomes and experiences on allogeneic hematopoietic stem cell transplantation (HSCT) in elderly patients aged 60 years and older with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) in South Korea, and to compare them with other studies.
Materials and Methods:
We analyzed the clinical outcomes of 116 patients with AML or MDS aged 60 years and older who underwent allogeneic HSCT. We also analyzed which pretreatment factors affect the overall survival (OS) after allogeneic HSCT.
Results:
Neutrophil and platelet engraftment were achieved at median day +11 [interquartile range (IQR) 10–15] and +14 (IQR 11–19), respectively. A complete donor chimerism was confirmed in 65 (56.0%) patients at 3 weeks and in 63 (54.3%) patients at 3 months after HSCT. The estimated incidence of grade II–IV acute graft-versus-host disease (GVHD) at day 100 was 13.7%. The estimated incidence of chronic GVHD at 2 years was 38.8%. Within a median follow-up of 14 months after HSCT, OS was 64% at 1 year and 55% at 2 years, and non-relapse mortality (NRM) was 20% at 1 year and 28% at 2 years. Multivariate analysis revealed that male sex and Hematopoietic Cell Transplantation-Specific Comorbidity Index ≥3 were associated with poor OS.
Conclusion
This study showed that allogeneic HSCT in elderly adults aged 60 and older can be performed with successful engraftment and acceptable NRM and OS are expected given the generally known survival of patients with higher risk MDS and poor risk AML.
3.Effects of Omicron Infection and Changes in Serum Antibody Response to Wild-Type, Delta, and Omicron After a Booster Dose With BNT163b2 Vaccine in Korean Healthcare Workers
Sung Hee LIM ; Han Jo KIM ; Se Hyung KIM ; Seong Hyeok CHOI ; Bora KIM ; Ji Youn KIM ; Young Sok JI ; Tark KIM ; Eun Ju CHOO ; Jung Chan JUNG ; Ji Eun MOON ; Chan Kyu KIM ; Seong Kyu PARK ; Jina YUN
Journal of Korean Medical Science 2023;38(13):e103-
Background:
Although the primary vaccine coverage rate for coronavirus disease 2019 (COVID-19) in South Korea has exceeded 80%, the coronavirus continues to spread, with reports of a rapid decline in vaccine effectiveness. South Korea is administering booster shots despite concerns about the effectiveness of the existing vaccine.
Methods:
Neutralizing antibody inhibition scores were evaluated in two cohorts after the booster dose. For the first cohort, neutralizing activity against the wild-type, delta, and omicron variants after the booster dose was evaluated. For the second cohort, we assessed the difference in neutralizing activity between the omicron infected and uninfected groups after booster vaccination. We also compared the effectiveness and adverse events (AEs) between homologous and heterologous booster doses for BNT162b2 or ChAdOx1 vaccines.
Results:
A total of 105 healthcare workers (HCWs) that were additionally vaccinated with BNT162b2 at Soonchunhyang University Bucheon Hospital were enrolled in this study.Significantly higher surrogate virus neutralization test (sVNT) inhibition (%) was observed for the wild-type and delta variants compared to sVNT (%) for the omicron after the booster dose (97%, 98% vs. 75%; P < 0.001). No significant difference in the neutralizing antibody inhibition score was found between variants in the BNT/BNT/BNT group (n = 48) and the ChA/ChA/BNT group (n = 57). Total AEs were not significantly different between the ChA/ ChA/BNT group (85.96%) and the BNT/BNT group (95.83%; P = 0.11). In the second cohort with 58 HCWs, markedly higher sVNT inhibition to omicron was observed in the omicroninfected group (95.13%) compared to the uninfected group (mean of 48.44%; P < 0.001) after four months of the booster dose. In 41 HCWs (39.0%) infected with the omicron variant, no difference in immunogenicity, AEs, or effectiveness between homogeneous and heterogeneous boosters was observed.
Conclusion
Booster vaccination with BNT162b2 was significantly less effective for the neutralizing antibody responses to omicron variant compared to the wild-type or delta variant in healthy population. Humoral immunogenicity was sustained significantly high after 4 months of booster vaccine in the infected population after booster vaccination.Further studies are needed to understand the characteristics of immunogenicity in these populations.
4.Is Treosulfan-Based Conditioning Attractive as a Reduced-Intensity Conditioning Regimen in Korea?
Se Hyung KIM ; Young Sok JI ; Jina YUN ; Seong Hyeok CHOI ; Sung Hee LIM ; Chan Kyu KIM ; Seong Kyu PARK
Journal of Korean Medical Science 2023;38(36):e281-
Background:
Allogeneic hematopoietic stem cell transplantation (HSCT) was not actively performed in elderly acute myeloid leukemia (AML) or myelodysplastic syndrome patients who are at a high-risk based on hematopoietic cell transplantation-specific comorbidity index (HCT-CI). The advent of reduced-intensity conditioning (RIC) regimens has made HSCT applicable in this population. However, the selection of appropriate conditioning is a major concern for the attending physician. The benefits of combination of treosulfan and fludarabine (Treo/Flu) have been confirmed through many clinical studies. Korean data on treosulfan-based conditioning regimen are scarce.
Methods:
A retrospective study was conducted to compare the clinical outcomes of allogeneic HSCT using RIC between 13 patients receiving Treo/Flu and 39 receiving busulfan/ fludarabine (Bu/Flu).
Results:
In terms of conditioning-related complications, the frequency of ≥ grade 2 nausea or vomiting was significantly lower and the duration of symptoms was shorter in the Treo/ Flu group than in the Bu/Flu group. The incidence of ≥ grade 2 mucositis tended to be lower in the Treo/Flu group. In the analysis of transplant outcomes, all events of acute graft versus host disease (GVHD) and ≥ grade 2 acute GVHD occurred more frequently in the Treo/ Flu group. The frequency of Epstein-Barr virus reactivation was significantly higher in the Treo/Flu group (53.8% vs. 23.1%, P = 0.037). Non-relapse mortality (NRM) at 12 months was higher in the Treo/Flu group (30.8% vs. 7.7%, P = 0.035). Significant prognostic factors included disease type, especially secondary AML, disease status and high-risk based on HCT-CI, ≥ grade 2 acute GVHD, and cases requiring ≥ 2 immunosuppressive drugs for treating acute GVHD. In the comparison of survival outcomes according to conditioning regimen, the Bu/Flu group seemed to show better results than the Treo/Flu group (60% vs.46.2%, P = 0.092 for overall survival; 56.4% vs. 38.5%, P = 0.193 for relapse-free survival). In additional analysis for only HCT-CI high-risk groups, there was no difference in transplant outcomes except that the Treo/Flu group tended to have a higher NRM within one year after transplantation. Survival outcomes of both groups were similar.
Conclusion
This study suggests that Treo/Flu conditioning may be an alternative to Bu/Flu regimen in elderly patients with high-risk who are not suitable for standard conditioning.
5.Analysis of factors influencing emergency physician’s choice of specialty again using machine learning method
Jee Young PARK ; Hyung Min LEE ; Kwang Hyun CHO ; In Byung KIM ; Mi Jin LEE ; Yoo Sang YOON ; Kyung Hye PARK ; Song Yi PARK ; Hong Jae KIM ; Dong Hoon KEY ; Beom Sok SEO ; Young Min JOO ; Chang Gun JEE ; Suk Jae CHOI ; In Hwan YEO ; Ji Hun KANG ; Woo Jin JUNG ; Dae Sung LIM ; Eu Sun LEE
Journal of the Korean Society of Emergency Medicine 2022;33(4):57-66
Objective:
Machine learning is emerging as a new alternative in various scientific fields and is potentially a new method of interpretation. Using the Light Gradient Boosting Machine (LightGBM), we analyzed the factors that influence the rechoice of emergency medicine responders. The survey is a cross-sectional study which provides an accurate understanding of a responder's current status. However, the results may vary depending on the composition, format, and question, and the relationship between the answers may be unclear.
Methods:
This study evaluated the modified 2020 Korean Emergency Physician Survey raw data. We applied the preferred model for random relationship check, random forest, support vector machine, and LightGBM models. The stacking ensemble model was used for the final decision process.
Results:
‘It is fun working in an emergency room’was the most selected response factor for re-choice, followed by ‘interesting major’. The physical burden of age and lack of identity had a negative impact, whereas burnout and emotional stress factors had a lesser effect. Anxiety caused by the coronavirus disease 2019 (COVID-19) is thought to have a significant impact on this decision making.
Conclusion
Establishing the identity of emergency medicine and being faithful to its fundamental mission is a way to increase the rate of re-choice. Decreasing the burden of workload modified according to age is recommended to establish career longevity. The method of machine learning presents us with a new possibility of checking the relevance of survey results quickly and easily.
6.What does it take to work healthy as an emergency physician?
Min Seok JANG ; Hyung Min LEE ; Kwang Hyun CHO ; In Byung KIM ; Mi Jin LEE ; Yoo Sang YOON ; Kyung Hye PARK ; Song Yi PARK ; Hong Jae KIM ; Dong Hoon KEY ; Beom Sok SEO ; Young Min JOO ; Chang Gun JEE ; Suk Jae CHOI ; In Hwan YEO ; Ji Hun KANG ; Woo Jin JUNG ; Dae Sung LIM ; Eu Sun LEE
Journal of the Korean Society of Emergency Medicine 2022;33(4):20-28
Objective:
Unlike the temporary nature of an emergency resident's job, the position of an emergency physician is one of a lifelong commitment requiring stability and persistence. However, it is hard to pursue a healthy lifestyle because of the 24 hours a day, 7 days a week (24/7) working schedule. The emergency room environment demands high physical and mental stamina, and hence the health problems of emergency physicians have a significant impact on the patient’s outcome. Our study was designed to analyze the emergency physician’s health status and influencing factors based on the data from the 2020 Korean Emergency Physician Survey.
Methods:
Based on the results of the survey, the factors affecting health were classified into several categories, such as personal character, working conditions, lifestyle, and emotional status. Statistical methods have been used to determine whether these factors can affect self-rated health.
Results:
The self-rated health worsened for emergency physicians in their 40s rather than in their 30s. However, drinking, smoking, and eating patterns had no effect on self-rated health. Also, the actual number of shifts was observed to bear no relationship with health. Sleeping, wellness, and mood affected self-rated health. Physicians who felt they were unhealthy, expected an early retirement because of the burden of night shifts.
Conclusion
Emergency physicians in Korea have a low self-rated health status. Mental stress, exercise, and sleep had an impact on the status. Physicians who served long-term night shifts saw a deleterious effect on their sleep and mood, and this damage was cumulative. The career longevity of an emergency physician thus requires a reasonable night shift schedule and age-modified adjustments.
7.Analysis of emergency residents health status and affected factors by 2019 Korean Emergency Medicine Resident Survey (KEMRS)
Seung Ju HAN ; Hyung Min LEE ; Kwang Hyun CHO ; Beom Sok SEO ; Yoo Sang YOON ; Kyung Hye PARK ; Song Yi PARK ; Suk Jae CHOI ; Eu Sun LEE
Journal of the Korean Society of Emergency Medicine 2022;33(3):288-296
Objective:
Emergency medicine residents are expected to exhibit a poor health status due to excessive working hours and high stress. Because much of patient care depends on them, their health conditions will have a significant impact on patient outcomes. Our study was designed to analyze the health status of emergency medicine residents and the affecting factors using the 2019 Korean Emergency Medicine Residents Survey (KEMRS) results.
Methods:
The study evaluated the self-rated health-defined percentage of responders who thought they were in good health. Based on this response, the influencing factors were categorized statistically. These factors included personal characteristics, lifestyle (drinking, smoking, eating, sleeping, and exercise), and emotional stress.
Results:
Of a total of 384 respondents, 176 (46%) thought they were in good health. Participants who perceived themselves to be unhealthy included residents who were married, female, and those in the 3rd grade. Drinking and smoking were not perceived to affect health status, but regular exercise and proper eating patterns were seen to be positive influencing factors. Daytime sleepiness, depressive moods, and personal well-being were correlated with health status.
Conclusion
While personal characteristics and emotional problems cannot be changed easily, lifestyle changes can be made for better health. The health conditions of emergency residents have not been considered a matter of importance thus far. To overcome their health problems, responsible improvements in schedules and a program of long-term follow-ups need to be implemented, followed by training programs.
8.Analysis on the ratio of emergency department visits by elderly and non-elderly patients based on disease and particulate matter concentration in South Korea: a multicenter cross-sectional observational study
Geon Hee HAN ; Suyeon PARK ; Youngjoo LEE ; Hye Young JANG ; Young Shin CHO ; Heajin CHUNG ; Sang-Il KIM ; Beom Sok SEO ; Young Wha SOHN ; Joonbum PARK
Journal of the Korean Society of Emergency Medicine 2021;32(6):698-711
Objective:
Many previous studies have reported relationships between particulate matter < 10 μm (PM10) and asthma in emergency department (ED) settings, but few have examined its effect on cerebrovascular diseases. We evaluate the “Lag effect” between PM10 and asthma, chronic obstructive pulmonary disease (COPD), myocardial infarction (MI), and ischemic and hemorrhagic stroke among patients that visited an ED.
Methods:
This study was retrospectively conducted on 96,077 patients that visited one of the 137 EDs in Seoul, Incheon, and Gyeonggi Province in South Korea in 2017. Medical information and 10th revision International Classification of Disease codes were obtained from the National Emergency Department Information System and PM10 levels from AirKorea. We used Poisson regression analysis to evaluate the lag effects of PM10 on diseases of interest. “Lag day 0” was defined as the day when PM10 > 80 μg/m3, and the PM10 values on the 5 following days were recorded. To assess the cumulative effects of PM10, we calculated relative risk (RR) by analyzing the cumulative effects over 6 days (lag days 0 to 5).
Results:
Asthma, COPD, and ischemic stroke patients (< 65 years old) showed a positive correlation between PM10 (asthma on lag day 5: RR, 2.587; 95% confidence interval [CI], 2.001-3.344; COPD on lag day 4: RR, 3.727; 95% CI, 2.988-4.650; and ischemic stroke on lag day 4: RR, 1.573; 95% CI, 1.168-2.118). MI in those≥65 showed the highest RR on lag day 1 (RR, 1.471; 95% CI, 1.042-2.077). Hemorrhagic stroke was not found to be significantly correlated with PM10 in either age group.
Conclusion
An increase in PM10 is associated with ED visits by patients<65 years old with asthma, COPD, or ischemic stroke, and with MI for those≥65 years.
9.Reference Ranges of Serum Insulin-Like Growth Factor-I and Insulin-Like Growth Factor Binding Protein-3: Results from a Multicenter Study in Healthy Korean Adults
In-Kyung JEONG ; Jong Kyu BYUN ; Junghyun NOH ; Sang Wan KIM ; Yoon-Sok CHUNG ; Tae Sun PARK ; Sung-Woon KIM
Endocrinology and Metabolism 2020;35(4):954-959
Insulin-like growth factor-I (IGF-I) plays a pivotal role in the diagnosis and treatment of growth hormone (GH) excess or deficiency. The GH study group of the Korean Endocrine Society aims to establish the Korean reference ranges of serum IGF-I and insulin-like growth factor binding protein-3 (IGFBP-3) and assess the relationship between IGF-I and IGFBP-3 and clinical parameters. Fasting serum was collected from healthy Korean adults at health promotion centers of five hospitals nationwide. Serum IGF-I and IGFBP-3 were measured via an immunoradiometric assay using a DSL kit (Diagnostic Systems Laboratories). Serum samples from 354 subjects (180 male, 174 female) were analyzed based on sex at 10-year intervals from 21 to 70 years. IGF-I levels were inversely correlated with age. After adjustment of age, the IGF-I/IGFBP-3 ratio was significantly negatively associated with blood pressure and free thyroxine and positively associated with weight, hemoglobin, creatinine, alanine transferase, fasting glucose, and thyroid stimulating hormone. Therefore, age- and sex-specific reference ranges of serum IGF-I and IGFBP-3 can be efficient in evaluating GH excess or deficiency in Korean population.
10.Robotic Versus Laparoscopic Surgery for Rectal Cancer after Preoperative Chemoradiotherapy: Case-Matched Study of Short-Term Outcomes.
Yong Sok KIM ; Min Jung KIM ; Sung Chan PARK ; Dae Kyung SOHN ; Dae Yong KIM ; Hee Jin CHANG ; Byung Ho NAM ; Jae Hwan OH
Cancer Research and Treatment 2016;48(1):225-231
PURPOSE: Robotic surgery is expected to have advantages over laparoscopic surgery; however, there are limited data regarding the feasibility of robotic surgery for rectal cancer after preoperative chemoradiotherapy (CRT). Therefore, we evaluated the short-term outcomes of robotic surgery for rectal cancer. MATERIALS AND METHODS: Thirty-three patients with cT3N0-2 rectal cancer after preoperative CRT who underwent robotic low anterior resection (R-LAR) between March 2010 and January 2012 were matched with 66 patients undergoing laparoscopic low anterior resection (L-LAR). Perioperative clinical outcomes and pathological data were compared between the two groups. RESULTS: Patient characteristics did not differ significantly different between groups. The mean operation time was 441 minutes (R-LAR) versus 277 minutes (L-LAR, p < 0.001). The open conversion rate was 6.1% in the R-LAR group and 0% in the L-LAR group (p=0.11). There were no significant differences in the time to flatus passage, length of hospital stay, and postoperative morbidity. In pathological review, the mean number of harvested lymph nodes was 22.3 in R-LAR and 21.6 in L-LAR (p=0.82). Involvement of circumferential resection margin was positive in 16.1% and 6.7%, respectively (p=0.42). Total mesorectal excision (TME) quality was complete in 97.0% in R-LAR and 91.0% in L-LAR (p=0.41). CONCLUSION: In our study, short-term outcomes of robotic surgery for rectal cancer after CRT were similar to those of laparoscopic surgery in respect to bowel function recovery, morbidity, and TME quality. Well-designed clinical trials are needed to evaluate the functional results and long-term outcomes of robotic surgery for rectal cancer.
Chemoradiotherapy*
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Flatulence
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Humans
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Laparoscopy*
;
Length of Stay
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Lymph Nodes
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Recovery of Function
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Rectal Neoplasms*

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