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.Allergen sensitization trajectories in children with respiratory and allergic diseases
So Won JO ; Soyoung JEON ; Hye Sun LEE ; Ha Min KIM ; Yoon Young NO ; Mi Reu PARK ; Jae Hwa JUNG ; Soo Yeon KIM ; Jong Duck KIM ; Min Jung KIM ; Yong Ju LEE ; Kyung Won KIM ; Myung Hyun SOHN ; Yoon Hee KIM
Allergy, Asthma & Respiratory Disease 2023;11(1):34-42
Purpose:
There is a lack of a report about the trajectories of allergen sensitization, although it is important to understand the change of allergen sensitization to manage allergic disease. This study aimed to analyze the change and trajectories of allergen sensitization in children with respiratory and allergic diseases.
Methods:
From 2006 to 2020, children with respiratory and allergic diseases or screened for allergic sensitization were evaluated. We visualized the alterations and the trajectories of allergen sensitization using stacked area graphs, box plots, and Sankey diagrams.
Results:
A total of 2,804 subjects were included, and allergic rhino-conjunctivitis was diagnosed in 1,931 children (68.9%). The mean age for the first test was 4.1 years, and that for the second test was 6.5 years. Children sensitized to class 1 food allergen before age 5 showed sensitizations more for other allergens and at a younger age after age 5 than children who were not. The atopic tendency continued once it had been obtained before the early school age in the persistence or the new development of sensitization.
Conclusion
Allergen sensitization has changed over time and has shown different patterns according to age. Its trajectory has taken a wide variety of courses in children with respiratory and allergic diseases until the early school age. These changes reflect the allergic diseases and socio-environmental characteristics of children and adolescents.
3.Effect of Home-based Self-administered Transcranial Direct Stimulation in Patients with Mild to Moderate Major Depressive Disorder: A Single-arm, Multicentral Trial
Jihoon OH ; Sekye JEON ; Tae Hyon HA ; Woojae MYUNG ; Seung-Hwan LEE ; Young-Hoon KO ; Do Hoon KIM ; Hwa-Young LEE ; Jeong-Ho CHAE
Clinical Psychopharmacology and Neuroscience 2023;21(2):271-278
Objective:
Although the effects and safety of transcranial direct current stimulation (tDCS) treatment in depressive patients are largely investigated, whether the self-administration of tDCS treatment at patient’s home is comparable to clinic-based treatment is still unknown.
Methods:
In this single-arm, multi-center clinical trial, 61 patients with mild to moderate major depressive disorder were enrolled. tDCS treatment was delivered at the patient’s home once a day, 5 to 7 times a week for 6 weeks, and each session lasted for 30 minutes. The primary outcome was a total Beck-Depression Inventory-II score, and no concurrent antidepressants were used.
Results:
The remission rates in both Full-Analysis (FA) (n = 61) and Per-Protocol (PP) (n = 43) groups were statistically significant (FA: 57.4% [0.44−0.70], PP: 62.8% [0.47−0.77]; percent [95% confidence interval]). The degree of depression-related symptoms was also significantly improved in 2, 4, and 6 weeks after the treatment when compared with baseline. There was no significant association between treatment compliance and remission rate in both FA and PP groups.
Conclusion
These results suggest that acute treatment of patient-administered tDCS might be effective in improving the subjective feeling of depressive symptoms in mild to moderate major depressive disorder patients.
4.Lenalidomide for anemia correction in lower-risk del(5q) myelodysplastic syndrome patients of Asian ethnicity
Junshik HONG ; Yoo Jin LEE ; Sung Hwa BAE ; Jun Ho YI ; Sungwoo PARK ; Myung Hee CHANG ; Young Hoon PARK ; Shin Young HYUN ; Joo-Seop CHUNG ; Ji Eun JANG ; Joo Young JUNG ; So-Yeon JEON ; Seo-Young SONG ; Hawk KIM ; Dae Sik KIM ; Sung-Hyun KIM ; Min Kyoung KIM ; Sang Hoon HAN ; Seonyang PARK ; Yoo-Jin KIM ; Je-Hwan LEE ;
Blood Research 2021;56(2):102-108
Background:
To estimate real-world outcomes in East Asian populations, we conducted a nationwide retrospective analysis of the efficacy and safety of lenalidomide for del(5q) myelodysplastic syndrome (MDS) patients with transfusion-dependent anemia in Korea.
Methods:
Patients aged ≥19 years who had received lenalidomide for the treatment of lower-risk, red blood cell (RBC) transfusion-dependent del(5q) MDS were selected. A filled case report form (CRF) with information from electronic medical records was requested from members of the acute myeloid leukemia (AML)/MDS Working Party of the Korean Society of Hematology. All the CRFs were gathered and analyzed.
Results:
A total of 31 patients were included in this study. Of 28 evaluable patients, 19 (67.9%) achieved RBC transfusion independence (RBC-TI). Female sex and the development of thrombocytopenia during treatment were associated with achieving RBC-TI. The most common non-hematologic toxicities were pruritus, fatigue, and rashes. All non-hematologic toxicities of grades ≥3 were limited to rash (12.9%) and pruritus (6.5%). Dose reduction was required in 15 of the 19 responders (78.9%). The most common final stable dosing schedule for the responders was 5 mg once every other day (31.6%).
Conclusion
Lenalidomide efficacy and tolerability were similar in the Asian del(5q) MDS patients and western patients. Dose reduction during treatment was common, but it was not associated with inferior outcomes.
5.Lenalidomide for anemia correction in lower-risk del(5q) myelodysplastic syndrome patients of Asian ethnicity
Junshik HONG ; Yoo Jin LEE ; Sung Hwa BAE ; Jun Ho YI ; Sungwoo PARK ; Myung Hee CHANG ; Young Hoon PARK ; Shin Young HYUN ; Joo-Seop CHUNG ; Ji Eun JANG ; Joo Young JUNG ; So-Yeon JEON ; Seo-Young SONG ; Hawk KIM ; Dae Sik KIM ; Sung-Hyun KIM ; Min Kyoung KIM ; Sang Hoon HAN ; Seonyang PARK ; Yoo-Jin KIM ; Je-Hwan LEE ;
Blood Research 2021;56(2):102-108
Background:
To estimate real-world outcomes in East Asian populations, we conducted a nationwide retrospective analysis of the efficacy and safety of lenalidomide for del(5q) myelodysplastic syndrome (MDS) patients with transfusion-dependent anemia in Korea.
Methods:
Patients aged ≥19 years who had received lenalidomide for the treatment of lower-risk, red blood cell (RBC) transfusion-dependent del(5q) MDS were selected. A filled case report form (CRF) with information from electronic medical records was requested from members of the acute myeloid leukemia (AML)/MDS Working Party of the Korean Society of Hematology. All the CRFs were gathered and analyzed.
Results:
A total of 31 patients were included in this study. Of 28 evaluable patients, 19 (67.9%) achieved RBC transfusion independence (RBC-TI). Female sex and the development of thrombocytopenia during treatment were associated with achieving RBC-TI. The most common non-hematologic toxicities were pruritus, fatigue, and rashes. All non-hematologic toxicities of grades ≥3 were limited to rash (12.9%) and pruritus (6.5%). Dose reduction was required in 15 of the 19 responders (78.9%). The most common final stable dosing schedule for the responders was 5 mg once every other day (31.6%).
Conclusion
Lenalidomide efficacy and tolerability were similar in the Asian del(5q) MDS patients and western patients. Dose reduction during treatment was common, but it was not associated with inferior outcomes.
6.The effect of probiotics supplementation in postoperative cancer patients: a prospective pilot study
Hyeji KWON ; Song Hwa CHAE ; Hyo Jin JUNG ; Hyeon Min SHIN ; O-Hyun BAN ; Jungwoo YANG ; Jung Ha KIM ; Ji Eun JEONG ; Hae Myung JEON ; Yong Won KANG ; Chan Kum PARK ; Daeyoun DAVID WON ; Jong Kyun LEE
Annals of Surgical Treatment and Research 2021;101(5):281-290
Purpose:
Microbiota manipulation through selected probiotics may be a promising tool to prevent cancer development as well as onset, to improve clinical efficacy for cancer treatments. The purpose of this study was to evaluate change in microbiota composition after-probiotics supplementation and assessed the efficacy of probiotics in improving quality of life (QOL) in postoperative cancer patients.
Methods:
Stool samples were collected from 30 cancer patients from February to October 2020 before (group I) and after (group II) 8 weeks of probiotics supplementation. We performed 16S ribosomal RNA gene sequencing to evaluate differences in gut microbiota between groups by comparing gut microbiota diversity, overall composition, and taxonomic signature abundance. The health-related QOL was evaluated through the EORTC Quality of life Questionnaire Core 30 questionnaire.
Results:
Statistically significant differences were noted in group II; increase of Shannon and Simpson index (P = 0.004 and P = 0.001), decrease of Bacteroidetes and Fusobacteria at the phylum level (P = 0.032 and P = 0.014, retrospectively), increased of beneficial bacteria such as Weissella (0.096% vs. 0.361%, P < 0.004), Lactococcus (0.023% vs. 0.16%, P < 0.001), and Catenibacterium (0.0% vs. 0.005%, P < 0.042) at the genus level. There was a significant improvement in sleep disturbance (P = 0.039) in group II.
Conclusion
Gut microbiota in cancer patients can be manipulated by specific probiotic strains, result in an altered microbiota. Microbiota modulation by probiotics can be considered as part of a supplement that helps to increase gut microbiota diversity and improve QOL in cancer patients after surgery.
7.The KAAACI/KDA Evidence-Based Practice Guidelines for Chronic Spontaneous Urticaria in Korean Adults and Children: Part 1. Definition, Methodology and First-line Management
Woo-Jung SONG ; Mira CHOI ; Dong Hun LEE ; Jae-Woo KWON ; Gun-Woo KIM ; Myung Hwa KIM ; Mi-Ae KIM ; Min-Hye KIM ; Byung-Keun KIM ; Sujeong KIM ; Joung Soo KIM ; Jung Eun KIM ; Ju-Young KIM ; Joo-Hee KIM ; Hyun Jung KIM ; Hye One KIM ; Hyo-Bin KIM ; Joo Young ROH ; Kyung Hee PARK ; Kui Young PARK ; Han-Ki PARK ; Hyunsun PARK ; Jung Min BAE ; Ji Yeon BYUN ; Dae Jin SONG ; Young Min AHN ; Seung Eun LEE ; Young Bok LEE ; Joong Sun LEE ; Ji Hyun LEE ; Kyung-Hwan LIM ; Young-Min YE ; Yoon-Seok CHANG ; You Hoon JEON ; Jiehyun JEON ; Mihn-Sook JUE ; Sun Hee CHOI ; Jeong-Hee CHOI ; Gyu-Young HUR ; Young Min PARK ; Dae Hyun LIM ; Sang Woong YOUN
Allergy, Asthma & Immunology Research 2020;12(4):563-578
Chronic spontaneous urticaria (CSU) is defined as the occurrence of spontaneous wheals, angioedema, or both for >6 weeks in the absence of specific causes. It is a common condition associated with substantial disease burden both for affected individuals and societies in many countries, including Korea. CSU frequently persists for several years and requires high-intensity treatment; therefore, patients experience deteriorations in quality of life and medication-associated complications. During the last decade, there have been major advances in the pharmacological treatment of CSU and there is an outstanding need for evidence-based guidelines that reflect clinical practice in Korea. The guidelines reported here represent a joint initiative of the Korean Academy of Asthma, Allergy and Clinical Immunology and the Korean Dermatological Association, and aim to provide evidence-based guidance for the management of CSU in Korean adults and children. In Part 1, disease definition, guideline scope and development methodology as well as evidence-based recommendations on the use of antihistamines and corticosteroids are summarized.
8.The KAAACI/KDA Evidence-Based Practice Guidelines for Chronic Spontaneous Urticaria in Korean Adults and Children: Part 1. Definition, Methodology and First-line Management
Woo-Jung SONG ; Mira CHOI ; Dong Hun LEE ; Jae-Woo KWON ; Gun-Woo KIM ; Myung Hwa KIM ; Mi-Ae KIM ; Min-Hye KIM ; Byung-Keun KIM ; Sujeong KIM ; Joung Soo KIM ; Jung Eun KIM ; Ju-Young KIM ; Joo-Hee KIM ; Hyun Jung KIM ; Hye One KIM ; Hyo-Bin KIM ; Joo Young ROH ; Kyung Hee PARK ; Kui Young PARK ; Han-Ki PARK ; Hyunsun PARK ; Jung Min BAE ; Ji Yeon BYUN ; Dae Jin SONG ; Young Min AHN ; Seung Eun LEE ; Young Bok LEE ; Joong Sun LEE ; Ji Hyun LEE ; Kyung-Hwan LIM ; Young-Min YE ; Yoon-Seok CHANG ; You Hoon JEON ; Jiehyun JEON ; Mihn-Sook JUE ; Sun Hee CHOI ; Jeong-Hee CHOI ; Gyu-Young HUR ; Young Min PARK ; Dae Hyun LIM ; Sang Woong YOUN
Allergy, Asthma & Immunology Research 2020;12(4):563-578
Chronic spontaneous urticaria (CSU) is defined as the occurrence of spontaneous wheals, angioedema, or both for >6 weeks in the absence of specific causes. It is a common condition associated with substantial disease burden both for affected individuals and societies in many countries, including Korea. CSU frequently persists for several years and requires high-intensity treatment; therefore, patients experience deteriorations in quality of life and medication-associated complications. During the last decade, there have been major advances in the pharmacological treatment of CSU and there is an outstanding need for evidence-based guidelines that reflect clinical practice in Korea. The guidelines reported here represent a joint initiative of the Korean Academy of Asthma, Allergy and Clinical Immunology and the Korean Dermatological Association, and aim to provide evidence-based guidance for the management of CSU in Korean adults and children. In Part 1, disease definition, guideline scope and development methodology as well as evidence-based recommendations on the use of antihistamines and corticosteroids are summarized.
9.2019 Tabletop Exercise for Laboratory Diagnosis and Analyses of Unknown Disease Outbreaks by the Korea Centers for Disease Control and Prevention
Il-Hwan KIM ; Jun Hyeong JANG ; Su-Kyoung JO ; Jin Sun NO ; Seung-Hee SEO ; Jun-Young KIM ; Sang-Oun JUNG ; Jeong-Min KIM ; Sang-Eun LEE ; Hye-Kyung PARK ; Eun-Jin KIM ; Jun Ho JEON ; Myung-Min CHOI ; Bo yeong RYU ; Yoon Suk JANG ; Hwa mi KIM ; Jin LEE ; Seung-Hwan SHIN ; Hee Kyoung KIM ; Eun-Kyoung KIM ; Ye Eun PARK ; Cheon-Kwon YOO ; Sang-Won LEE ; Myung-Guk HAN ; Gi-Eun RHIE ; Byung Hak KANG
Osong Public Health and Research Perspectives 2020;11(5):280-285
Objectives:
The Korea Centers for Disease Control and Prevention has published “A Guideline for Unknown Disease Outbreaks (UDO).” The aim of this report was to introduce tabletop exercises (TTX) to prepare for UDO in the future.
Methods:
The UDO Laboratory Analyses Task Force in Korea Centers for Disease Control and Prevention in April 2018, assigned unknown diseases into 5 syndromes, designed an algorithm for diagnosis, and made a panel list for diagnosis by exclusion. Using the guidelines and laboratory analyses for UDO, TTX were introduced.
Results:
Since September 9th , 2018, the UDO Laboratory Analyses Task Force has been preparing TTX based on a scenario of an outbreak caused by a novel coronavirus. In December 2019, through TTX, individual missions, epidemiological investigations, sample treatments, diagnosis by exclusions, and next generation sequencing analysis were discussed, and a novel coronavirus was identified as the causal pathogen.
Conclusion
Guideline and laboratory analyses for UDO successfully applied in TTX. Conclusions drawn from TTX could be applied effectively in the analyses for the initial response to COVID-19, an ongoing epidemic of 2019 - 2020. Therefore, TTX should continuously be conducted for the response and preparation against UDO.
10.Effects of Appointing a Full-Time Neurointensivist to Run a Closed-Type Neurological Intensive Care Unit
Myung Ah KO ; Jung Hwa LEE ; Joong Goo KIM ; Suyeon JEONG ; Dong Wha KANG ; Chae Man LIM ; Sang Ahm LEE ; Kwang Kuk KIM ; Sang Beom JEON
Journal of Clinical Neurology 2019;15(3):360-368
BACKGROUND AND PURPOSE: To investigate whether appointing a full-time neurointensivist to manage a closed-type neurological intensive care unit (NRICU) improves the quality of critical care and patient outcomes. METHODS: This study included patients admitted to the NRICU at a university hospital in Seoul, Korea. Two time periods were defined according to the presence of a neurointensivist in the preexisting open-type NRICU: the before and after periods. Hospital medical records were queried and compared between these two time periods, as were the biannual satisfaction survey results for the families of patients. RESULTS: Of the 15,210 patients in the neurology department, 2,199 were admitted to the NRICU (n=995 and 1,204 during the before and after periods, respectively; p<0.001). The length of stay was shorter during the after than during the before period in both the NRICU (3 vs. 4 days; p<0.001) and the hospital overall (12.5 vs. 14.0 days; p<0.001). Neurological consultations (2,070 vs. 3,097; p<0.001) and intrahospital transfers from general intensive care units to the NRICU (21 vs. 40; p=0.111) increased from the before to after the period. The mean satisfaction scores of the families of the patients also increased, from 78.3 to 89.7. In a Cox proportional hazards model, appointing a neurointensivist did not result in a statistically significant change in 6-month mortality (hazard ratio, 0.82; 95% confidence interval, 0.652–1.031; p=0.089). CONCLUSIONS: Appointing a full-time neurointensivist to manage a closed-type NRICU had beneficial effects on quality indicators and patient outcomes.
Critical Care Outcomes
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Critical Care
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Humans
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Intensive Care Units
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Korea
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Length of Stay
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Medical Records
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Mortality
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Neurology
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Proportional Hazards Models
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Referral and Consultation
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Seoul

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