1.Efficacy and Safety of Metformin and Atorvastatin Combination Therapy vs. Monotherapy with Either Drug in Type 2 Diabetes Mellitus and Dyslipidemia Patients (ATOMIC): Double-Blinded Randomized Controlled Trial
Jie-Eun LEE ; Seung Hee YU ; Sung Rae KIM ; Kyu Jeung AHN ; Kee-Ho SONG ; In-Kyu LEE ; Ho-Sang SHON ; In Joo KIM ; Soo LIM ; Doo-Man KIM ; Choon Hee CHUNG ; Won-Young LEE ; Soon Hee LEE ; Dong Joon KIM ; Sung-Rae CHO ; Chang Hee JUNG ; Hyun Jeong JEON ; Seung-Hwan LEE ; Keun-Young PARK ; Sang Youl RHEE ; Sin Gon KIM ; Seok O PARK ; Dae Jung KIM ; Byung Joon KIM ; Sang Ah LEE ; Yong-Hyun KIM ; Kyung-Soo KIM ; Ji A SEO ; Il Seong NAM-GOONG ; Chang Won LEE ; Duk Kyu KIM ; Sang Wook KIM ; Chung Gu CHO ; Jung Han KIM ; Yeo-Joo KIM ; Jae-Myung YOO ; Kyung Wan MIN ; Moon-Kyu LEE
Diabetes & Metabolism Journal 2024;48(4):730-739
Background:
It is well known that a large number of patients with diabetes also have dyslipidemia, which significantly increases the risk of cardiovascular disease (CVD). This study aimed to evaluate the efficacy and safety of combination drugs consisting of metformin and atorvastatin, widely used as therapeutic agents for diabetes and dyslipidemia.
Methods:
This randomized, double-blind, placebo-controlled, parallel-group and phase III multicenter study included adults with glycosylated hemoglobin (HbA1c) levels >7.0% and <10.0%, low-density lipoprotein cholesterol (LDL-C) >100 and <250 mg/dL. One hundred eighty-five eligible subjects were randomized to the combination group (metformin+atorvastatin), metformin group (metformin+atorvastatin placebo), and atorvastatin group (atorvastatin+metformin placebo). The primary efficacy endpoints were the percent changes in HbA1c and LDL-C levels from baseline at the end of the treatment.
Results:
After 16 weeks of treatment compared to baseline, HbA1c showed a significant difference of 0.94% compared to the atorvastatin group in the combination group (0.35% vs. −0.58%, respectively; P<0.0001), whereas the proportion of patients with increased HbA1c was also 62% and 15%, respectively, showing a significant difference (P<0.001). The combination group also showed a significant decrease in LDL-C levels compared to the metformin group (−55.20% vs. −7.69%, P<0.001) without previously unknown adverse drug events.
Conclusion
The addition of atorvastatin to metformin improved HbA1c and LDL-C levels to a significant extent compared to metformin or atorvastatin alone in diabetes and dyslipidemia patients. This study also suggested metformin’s preventive effect on the glucose-elevating potential of atorvastatin in patients with type 2 diabetes mellitus and dyslipidemia, insufficiently controlled with exercise and diet. Metformin and atorvastatin combination might be an effective treatment in reducing the CVD risk in patients with both diabetes and dyslipidemia because of its lowering effect on LDL-C and glucose.
2.A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation
Guk Jin LEE ; Hyunho KIM ; Sung Shim CHO ; Hyung Soon PARK ; Ho Jung AN ; In Sook WOO ; Jae Ho BYUN ; Ji Hyung HONG ; Yoon Ho KO ; Der Sheng SUN ; Hye Sung WON ; Jong Youl JIN ; Ji Chan PARK ; In-Ho KIM ; Sang Young ROH ; Byoung Yong SHIM
Journal of Gastric Cancer 2023;23(2):315-327
Purpose:
Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy.
Materials and Methods:
Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level.
Results:
Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250–0.890; P=0.020).
Conclusions
After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.
3.Effect of shared decision-making education on physicians’ perceptions and practices of end-of-life care in Korea
Byung Chul YU ; Miyeun HAN ; Gang-Jee KO ; Jae Won YANG ; Soon Hyo KWON ; Sungjin CHUNG ; Yu Ah HONG ; Young Youl HYUN ; Jang-Hee CHO ; Kyung Don YOO ; Eunjin BAE ; Woo Yeong PARK ; In O SUN ; Dongryul KIM ; Hyunsuk KIM ; Won Min HWANG ; Sang Heon SONG ; Sung Joon SHIN
Kidney Research and Clinical Practice 2022;41(2):242-252
Evidence of the ethical appropriateness and clinical benefits of shared decision-making (SDM) are accumulating. This study aimed to not only identify physicians’ perspectives on SDM, and practices related to end-of-life care in particular, but also to gauge the effect of SDM education on physicians in Korea. Methods: A 14-item questionnaire survey using a modified Delphi process was delivered to nephrologists and internal medicine trainees at 17 university hospitals. Results: A total of 309 physicians completed the survey. Although respondents reported that 69.9% of their practical decisions were made using SDM, 59.9% reported that it is not being applied appropriately. Only 12.3% of respondents had received education on SDM as part of their training. The main obstacles to appropriate SDM were identified as lack of time (46.0%), educational materials and tools (29.4%), and education on SDM (24.3%). Although only a few respondents had received training on SDM, the proportion of those who thought they were using SDM appropriately in actual practice was high; the proportion of those who chose lack of time and education as factors that hindered the proper application of SDM was low. Conclusion: The majority of respondents believed that SDM was not being implemented properly in Korea, despite its use in actual practice. To improve the effectiveness of SDM in the Korean medical system, appropriate training programs and supplemental policies that guarantee sufficient application time are required.
4.Clinical Guidance for Point-of-Care Ultrasound in the Emergency and Critical Care Areas after Implementing Insurance Coverage in Korea
Wook Jin CHOI ; Young Rock HA ; Je Hyeok OH ; Young Soon CHO ; Won Woong LEE ; You Dong SOHN ; Gyu Chong CHO ; Chan Young KOH ; Han Ho DO ; Won Joon JEONG ; Seung Mok RYOO ; Jae Hyun KWON ; Hyung Min KIM ; Su Jin KIM ; Chan Yong PARK ; Jin Hee LEE ; Jae Hoon LEE ; Dong Hyun LEE ; Sin Youl PARK ; Bo Seung KANG
Journal of Korean Medical Science 2020;35(7):54-
Point-of-care ultrasound (POCUS) is a useful tool that is widely used in the emergency and intensive care areas. In Korea, insurance coverage of ultrasound examination has been gradually expanding in accordance with measures to enhance Korean National Insurance Coverage since 2017 to 2021, and which will continue until 2021. Full coverage of health insurance for POCUS in the emergency and critical care areas was implemented in July 2019. The National Health Insurance Act classified POCUS as a single or multiple-targeted ultrasound examination (STU vs. MTU). STU scans are conducted of one organ at a time, while MTU includes scanning of multiple organs simultaneously to determine each clinical situation. POCUS can be performed even if a diagnostic ultrasound examination is conducted, based on the physician's decision. However, the Health Insurance Review and Assessment Service plans to monitor the prescription status of whether the POCUS and diagnostic ultrasound examinations are prescribed simultaneously and repeatedly. Additionally, MTU is allowed only in cases of trauma, cardiac arrest, shock, chest pain, and dyspnea and should be performed by a qualified physician. Although physicians should scan all parts of the chest, heart, and abdomen when they prescribe MTU, they are not required to record all findings in the medical record. Therefore, appropriate prescription, application, and recording of POCUS are needed to enhance the quality of patient care and avoid unnecessary cut of medical budget spending. The present article provides background and clinical guidance for POCUS based on the implementation of full health insurance coverage for POCUS that began in July 2019 in Korea.
Abdomen
;
Budgets
;
Chest Pain
;
Critical Care
;
Dyspnea
;
Emergencies
;
Heart
;
Heart Arrest
;
Insurance Coverage
;
Insurance
;
Insurance, Health
;
Korea
;
Medical Records
;
National Health Programs
;
Patient Care
;
Point-of-Care Systems
;
Prescriptions
;
Shock
;
Thorax
;
Ultrasonography
5.Pathological, immunohistochemical, and bacteriological findings in dogs infected with Brucella canis
Ji-Youl JUNG ; Soon-Seek YOON ; Seunghee LEE ; Jung-Won PARK ; JinJu LEE ; Moon HER ; ByungJae SO ; Jae-Hoon KIM
Korean Journal of Veterinary Research 2020;60(1):9-14
This study describes pathological, immunohistochemical, and bacteriological findings in adult dogs and fetuses naturally infected with Brucella (B) canis. A total of 42 dogs including 40 dogs and 2 aborted fetuses were examined. The most common gross lesions in infected dogs were swelling of lymph nodes and spleen. The testes showed marked swelling with multifocal to diffuse reddish discoloration. The most significant histopathological lesions were observed in the placenta. Placental trophoblasts were markedly hypertrophied due to the accumulation of intra-cellular gram-negative bacteria. Lymphocytic inflammation of varying severity was observed in the reproductive organs such as male testis, epididymis, and prostate gland and female uterus. Strong immunolabelling was observed in the cytoplasm of most trophoblasts in the placental tissues using immunohistochemistry. However, immunohistochemical staining did not demonstrate any organisms in other organs of dogs and fetuses. B. canis isolates were most frequently obtained from the whole blood (82.5%) and superficial inguinal lymph node (77.5%) in both sexes. In addition, the isolation rate was higher in male genital organs than in those of females. Hence, management of male dogs is most important because infected dogs can play a role as carriers.
6.Clinical Guidance for Point-of-Care Ultrasound in the Emergency and Critical Care Areas after Implementing Insurance Coverage in Korea
Wook Jin CHOI ; Young Rock HA ; Je Hyeok OH ; Young Soon CHO ; Won Woong LEE ; You Dong SOHN ; Gyu Chong CHO ; Chan Young KOH ; Han Ho DO ; Won Joon JEONG ; Seung Mok RYOO ; Jae Hyun KWON ; Hyung Min KIM ; Su Jin KIM ; Chan Yong PARK ; Jin Hee LEE ; Jae Hoon LEE ; Dong Hyun LEE ; Sin Youl PARK ; Bo Seung KANG
Journal of Korean Medical Science 2020;35(7):e54-
Point-of-care ultrasound (POCUS) is a useful tool that is widely used in the emergency and intensive care areas. In Korea, insurance coverage of ultrasound examination has been gradually expanding in accordance with measures to enhance Korean National Insurance Coverage since 2017 to 2021, and which will continue until 2021. Full coverage of health insurance for POCUS in the emergency and critical care areas was implemented in July 2019. The National Health Insurance Act classified POCUS as a single or multiple-targeted ultrasound examination (STU vs. MTU). STU scans are conducted of one organ at a time, while MTU includes scanning of multiple organs simultaneously to determine each clinical situation. POCUS can be performed even if a diagnostic ultrasound examination is conducted, based on the physician's decision. However, the Health Insurance Review and Assessment Service plans to monitor the prescription status of whether the POCUS and diagnostic ultrasound examinations are prescribed simultaneously and repeatedly. Additionally, MTU is allowed only in cases of trauma, cardiac arrest, shock, chest pain, and dyspnea and should be performed by a qualified physician. Although physicians should scan all parts of the chest, heart, and abdomen when they prescribe MTU, they are not required to record all findings in the medical record. Therefore, appropriate prescription, application, and recording of POCUS are needed to enhance the quality of patient care and avoid unnecessary cut of medical budget spending. The present article provides background and clinical guidance for POCUS based on the implementation of full health insurance coverage for POCUS that began in July 2019 in Korea.
7.Korea HIV/AIDS Cohort Study: study design and baseline characteristics.
Bo Youl CHOI ; Jun Yong CHOI ; Sang Hoon HAN ; Sang Il KIM ; Mee Kyung KEE ; Min Ja KIM ; Shin Woo KIM ; Sung Soon KIM ; Yu Mi KIM ; Nam Su KU ; Jin Soo LEE ; Joo Shil LEE ; Yunsu CHOI ; Kyong Sil PARK ; Joon Young SONG ; Jun Hee WOO ; Moon Won KANG ; June KIM
Epidemiology and Health 2018;40(1):e2018023-
The number of persons infected by HIV/AIDS has consistently increased in Korea since the first case of HIV/AIDS infection in 1985 and reached 15,208 by 2016. About 1,100 new patients with HIV/ AIDS infections have emerged every year since 2013. In Korea, the Korea HIV/AIDS Cohort Study was established for the evidenced-based prevention, treatment, and effective management of patients infected with human immunodeficiency virus (HIV) in December 2006. This study monitored 1,438 patients, who accounted for about 10% of all patients with HIV/AIDS in Korea, for 10 years with the following aims: (1) to develop an administrative system for the establishment of a HIV/AIDS cohort-based study; (2) to standardize methodologies and the case report forms; and (3) to standardize multi-cohort data and develop a data cleaning method. This study aims to monitor at least 1,000 patients (excluding those for whom investigation had been completed) per year (estimated number of patients who can be monitored by January 2018: 939). By December 2016, the sex distribution was 93.3% for men, and 6.7% for women (gender ratio, 13.9:1.0), and 98.9% of all participants were Korean. More than 50.0% of the participants were confirmed as HIV positive after 2006. This study reports competitive, long-term research that aimed to develop policies for the prevention of chronic infectious diseases for patients with HIV. The data collected over the last decade will be used to develop indices for HIV treatment and health promotion.
Cohort Studies*
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Communicable Diseases
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Female
;
Health Promotion
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HIV
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Humans
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Korea*
;
Male
;
Methods
;
Sex Distribution
;
Sexually Transmitted Diseases
8.Asymptomatic Middle East Respiratory Syndrome coronavirus infection using a serologic survey in Korea.
Yeong Jun SONG ; Jeong Sun YANG ; Hee Jung YOON ; Hae Sung NAM ; Soon Young LEE ; Hae Kwan CHEONG ; Woo Jung PARK ; Sung Han PARK ; Bo Youl CHOI ; Sung Soon KIM ; Moran KI
Epidemiology and Health 2018;40(1):e2018014-
OBJECTIVES: The rates of asymptomatic infection with Middle East Respiratory Syndrome (MERS) coronavirus vary. A serologic study was conducted to determine the asymptomatic MERS infection rate in healthcare workers and non-healthcare workers by exposure status. METHODS: Study participants were selected from contacts of MERS patients based on a priority system in 4 regions strongly affected by the 2015 MERS outbreak. A sero-epidemiological survey was performed in 1,610 contacts (average duration from exposure to test, 4.8 months), and the collected sera were tested using an enzyme-linked immunespecific assay (ELISA), immunofluorescence assay (IFA), and plaque reduction neutralization antibody test (PRNT). Among the 1,610 contacts, there were 7 ELISA-positive cases, of which 1 exhibited positive IFA and PRNT results. RESULTS: The asymptomatic infection rate was 0.060% (95% confidence interval, 0.002 to 0.346). The asymptomatic MERS case was a patient who had been hospitalized with patient zero on the same floor of the hospital at the same time. The case was quarantined at home for 2 weeks after discharge, and had underlying diseases, including hypertension, angina, and degenerative arthritis. CONCLUSIONS: The asymptomatic infection was acquired via healthcare-associated transmission. Thus, it is necessary to extend serologic studies to include inpatient contacts who have no symptoms.
Asymptomatic Infections
;
Coronavirus
;
Coronavirus Infections*
;
Cross Infection
;
Delivery of Health Care
;
Epidemiology
;
Fluorescent Antibody Technique
;
Humans
;
Hypertension
;
Inpatients
;
Korea*
;
Middle East Respiratory Syndrome Coronavirus*
;
Middle East*
;
Osteoarthritis
9.Prevalence state of canine brucellosis in South Korea during 2015 and 2016
Ji Youl JUNG ; Soon Seek YOON ; Seung Hee LEE ; Jung Won PARK ; Jin Ju LEE ; Moon HER ; ByungJae SO ; Jae Hoon KIM
Korean Journal of Veterinary Research 2018;58(3):125-129
We investigated the prevalence of canine brucellosis in companion and stray dogs between March 2015 and December 2016 and determined the disease characteristics based on the geographic distribution, sex and age of the dogs in South Korea. We conducted a large-scale survey using serological and bacteriological tests. Samples were collected from 2,394 dogs (1,825 companions and 569 strays). Thirty (1.3%) samples were positive for Brucella canis antibodies including 16 (0.9%) from companion dogs and 14 (2.5%) from stray dogs. Two (1.0%) of the 196 samples cultured from the stray dogs were positive. When compared with male dogs, the female companion and stray dogs had a significantly higher prevalence of brucellosis. Moreover, the prevalence of canine brucellosis was significantly higher in stray dogs older than 6 years and the prevalence of the disease in companion dogs was highest in Incheon (2.1%) and Jeolla (2.1%) provinces. Stray dogs from the Daejeon metropolitan area had the highest prevalence of brucellosis (7.9%). National control measures for canine brucellosis have not previously been implemented. Our findings suggest that appropriate screening tests and control measures are necessary to improve the health of dogs and to protect public health in Korea, particularly with the rapid growth of the companion animal industry.
10.Prevalence state of canine brucellosis in South Korea during 2015 and 2016
Ji Youl JUNG ; Soon Seek YOON ; Seung Hee LEE ; Jung Won PARK ; Jin Ju LEE ; Moon HER ; ByungJae SO ; Jae Hoon KIM
Korean Journal of Veterinary Research 2018;58(3):125-129
We investigated the prevalence of canine brucellosis in companion and stray dogs between March 2015 and December 2016 and determined the disease characteristics based on the geographic distribution, sex and age of the dogs in South Korea. We conducted a large-scale survey using serological and bacteriological tests. Samples were collected from 2,394 dogs (1,825 companions and 569 strays). Thirty (1.3%) samples were positive for Brucella canis antibodies including 16 (0.9%) from companion dogs and 14 (2.5%) from stray dogs. Two (1.0%) of the 196 samples cultured from the stray dogs were positive. When compared with male dogs, the female companion and stray dogs had a significantly higher prevalence of brucellosis. Moreover, the prevalence of canine brucellosis was significantly higher in stray dogs older than 6 years and the prevalence of the disease in companion dogs was highest in Incheon (2.1%) and Jeolla (2.1%) provinces. Stray dogs from the Daejeon metropolitan area had the highest prevalence of brucellosis (7.9%). National control measures for canine brucellosis have not previously been implemented. Our findings suggest that appropriate screening tests and control measures are necessary to improve the health of dogs and to protect public health in Korea, particularly with the rapid growth of the companion animal industry.
Animals
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Antibodies
;
Bacteriology
;
Brucella canis
;
Brucellosis
;
Dogs
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Female
;
Friends
;
Humans
;
Incheon
;
Korea
;
Male
;
Mass Screening
;
Pets
;
Prevalence
;
Public Health
;
Sex Distribution

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