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.Early Prediction of Mortality for Septic Patients Visiting Emergency Room Based on Explainable Machine Learning: A Real-World Multicenter Study
Sang Won PARK ; Na Young YEO ; Seonguk KANG ; Taejun HA ; Tae-Hoon KIM ; DooHee LEE ; Dowon KIM ; Seheon CHOI ; Minkyu KIM ; DongHoon LEE ; DoHyeon KIM ; Woo Jin KIM ; Seung-Joon LEE ; Yeon-Jeong HEO ; Da Hye MOON ; Seon-Sook HAN ; Yoon KIM ; Hyun-Soo CHOI ; Dong Kyu OH ; Su Yeon LEE ; MiHyeon PARK ; Chae-Man LIM ; Jeongwon HEO ; On behalf of the Korean Sepsis Alliance (KSA) Investigators
Journal of Korean Medical Science 2024;39(5):e53-
Background:
Worldwide, sepsis is the leading cause of death in hospitals. If mortality rates in patients with sepsis can be predicted early, medical resources can be allocated efficiently. We constructed machine learning (ML) models to predict the mortality of patients with sepsis in a hospital emergency department.
Methods:
This study prospectively collected nationwide data from an ongoing multicenter cohort of patients with sepsis identified in the emergency department. Patients were enrolled from 19 hospitals between September 2019 and December 2020. For acquired data from 3,657 survivors and 1,455 deaths, six ML models (logistic regression, support vector machine, random forest, extreme gradient boosting [XGBoost], light gradient boosting machine, and categorical boosting [CatBoost]) were constructed using fivefold cross-validation to predict mortality. Through these models, 44 clinical variables measured on the day of admission were compared with six sequential organ failure assessment (SOFA) components (PaO 2 /FIO 2 [PF], platelets (PLT), bilirubin, cardiovascular, Glasgow Coma Scale score, and creatinine).The confidence interval (CI) was obtained by performing 10,000 repeated measurements via random sampling of the test dataset. All results were explained and interpreted using Shapley’s additive explanations (SHAP).
Results:
Of the 5,112 participants, CatBoost exhibited the highest area under the curve (AUC) of 0.800 (95% CI, 0.756–0.840) using clinical variables. Using the SOFA components for the same patient, XGBoost exhibited the highest AUC of 0.678 (95% CI, 0.626–0.730). As interpreted by SHAP, albumin, lactate, blood urea nitrogen, and international normalization ratio were determined to significantly affect the results. Additionally, PF and PLTs in the SOFA component significantly influenced the prediction results.
Conclusion
Newly established ML-based models achieved good prediction of mortality in patients with sepsis. Using several clinical variables acquired at the baseline can provide more accurate results for early predictions than using SOFA components. Additionally, the impact of each variable was identified.
3.Real-World Study of Osimertinib in Korean Patients with Epidermal Growth Factor Receptor T790M Mutation–Positive Non–Small Cell Lung Cancer
Jang Ho LEE ; Eun Young KIM ; Cheol-Kyu PARK ; Shin Yup LEE ; Min ki LEE ; Seong-Hoon YOON ; Jeong Eun LEE ; Sang Hoon LEE ; Seung Joon KIM ; Sung Yong LEE ; Jun Hyeok LIM ; Tae-Won JANG ; Seung Hun JANG ; Kye Young LEE ; Seung Hyeun LEE ; Sei Hoon YANG ; Dong Won PARK ; Chan Kwon PARK ; Hye Seon KANG ; Chang Dong YEO ; Chang-Min CHOI ; Jae Cheol LEE
Cancer Research and Treatment 2023;55(1):112-122
Purpose:
Although osimertinib is the standard-of-care treatment of epidermal growth factor receptor (EGFR) T790M mutation–positive non–small cell lung cancer, real-world evidence on the efficacy of osimertinib is not enough to reflect the complexity of the entire course of treatment. Herein, we report on the use of osimertinib in patients with EGFR T790M mutation–positive non–small cell lung cancer who had previously received EGFR tyrosine kinase inhibitor (TKI) treatment in Korea.
Materials and Methods:
Patients with confirmed EGFR T790M after disease progression of prior EGFR-TKI were enrolled and administered osimertinib 80 mg daily. The primary effectiveness outcome was progression-free survival, with time-to-treatment discontinuation, treatment and adverse effects leading to treatment discontinuation, and overall survival being the secondary endpoints.
Results:
A total of 558 individuals were enrolled, and 55.2% had investigator-assessed responses. The median progression-free survival was 14.2 months (95% confidence interval [CI], 13.0 to 16.4), and the median time-to-treatment discontinuation was 15.0 months (95% CI, 14.1 to 15.9). The median overall survival was 36.7 months (95% CI, 30.9 to not reached). The benefit with osimertinib was consistent regardless of the age, sex, smoking history, and primary EGFR mutation subtype. However, hepatic metastases at the time of diagnosis, the presence of plasma EGFR T790M, and the shorter duration of prior EGFR-TKI treatment were poor predictors of osimertinib treatment. Ten patients (1.8%), including three with pneumonitis, had to discontinue osimertinib due to severe adverse effects.
Conclusion
Osimertinib demonstrated its clinical effectiveness and survival benefit for EGFR T790M mutation–positive in Korean patients with no new safety signals.
4.Awareness and Use of Complementary and Alternative Medicine in Korean Lung Cancer Patients
Joon Young CHOI ; Wonjun JI ; Chang-Min CHOI ; Chaeuk CHUNG ; Jae Myoung NOH ; Cheol-Kyu PARK ; In-Jae OH ; Hong In YOON ; Hyeong Ryul KIM ; Ho Young KIM ; Chang Dong YEO ; Seung Hun JANG ;
Tuberculosis and Respiratory Diseases 2021;84(2):105-114
Background:
Complementary and alternative medicine (CAM) has been used frequently, and its use continues to increase in lung cancer patients, despite insufficient scientific of its efficacy. To investigate this situation, we analyzed the current awareness and use of CAM in Korean lung-cancer patients. Methods: This prospective survey–based study was performed at seven medical centers in South Korea between August and October 2019. The survey assessed general patient characteristics and the awareness and use of CAM. We analyzed differences in the clinical parameters of patients aware and not aware of CAM and of CAM non-users and users.
Results:
Of the 434 patients included in this study, 68.8% responded that they were aware of CAM and 30.9% said they had experienced it. In univariate analysis, the patients aware of CAM were younger with poor performance status, had advanced-stage lung cancer, received more systemic therapy, and received concurrent chemoradiation therapy (CCRT). By multiple logistic regression, younger age, poor performance status, advanced stage, and prior CCRT were identified as independent risk factors for CAM awareness. There were no significant differences in the general characteristics and cancer-associated clinical parameters of CAM non-users and users.
Conclusion
Specific clinical parameters were associated with patients’ awareness of CAM, although there were no significantly different characteristics between CAM users and non-users.
5.Strategy for salvaging infected breast implants: lessons from the recovery of seven consecutive patients
Hyeonjung YEO ; Dongkyu LEE ; Jin Soo KIM ; Pil Seon EO ; Dong Kyu KIM ; Joon Seok LEE ; Ki Tae KWON ; Jeeyeon LEE ; Ho Yong PARK ; Jung Dug YANG
Archives of Plastic Surgery 2021;48(2):165-174
Background:
In recent years, implant-based breast reconstruction has been performed because of its simplicity, short operation time, and rapid recovery of patients. Several studies have reported treatment methods for implant surgery-related infection, which is a serious complication. The aim of this study was to introduce our strategy for salvaging infected implants and to evaluate its effectiveness.
Methods:
The authors performed a retrospective study of 145 cases from 132 patients who underwent implant-based breast reconstruction from January 2012 to December 2018. Empirical antibiotics were immediately administered to patients with suspected infections. The patients then underwent salvage treatment including appropriate antibiotics, ultrasonography-guided aspiration, debridement, antibiotic lavage, and implant exchange through a multidisciplinary approach. Patient demographics, operative data, duration until drain removal, adjuvant treatment, and complications were analyzed.
Results:
The total infection rate was 5.5% (8/145). A longer indwelling catheter period and adjuvant treatment were significantly associated with infection. The salvage treatment showed a success rate of 87.5% (7/8). Seven patients who received early aggressive salvage treatment recovered from infection. One patient with methicillin-resistant Staphylococcus aureus, who received salvage treatment 11 days after symptom onset, did not respond to drainage and antibiotic treatment. That patient subsequently underwent explantation.
Conclusions
In implant-based breast reconstruction, prevention of infection is of the utmost importance. However, if an infection is suspected, proactive empirical antibiotic therapy and collaboration with the necessary departments are required. Through a multidisciplinary approach and proactive early management, swift and appropriate salvage should be performed.
6.Bilateral Stress Fracture of Femur Neck, Fatigue Type of Non-Athlete Young Adult
Yeo Joon YUN ; Yong Jae NA ; Ji Won JUNG ; Kyu Hoon LEE
Clinical Pain 2019;18(2):126-129
Bilateral femoral neck stress fractures have been rarely reported. When diagnosed, they are usually limited to athletes or military personnel. A 35-year-old man, previously healthy, visited the emergency department for right inguinal pain. On physical examination, no external wound, tenderness or limitation of motion were found in either lower extremity. Plain radiography showed normal findings but an magnetic resonance image showed a linear fracture in the femoral neck. In this case, bilateral femoral neck stress fractures were found in a young non-athlete adult with no prior medical history of related injuries. Surgery is generally not performed for stress fractures but considering the patient's early mobilization and the need for quick reintegration into society, surgery was done in this case.
Adult
;
Athletes
;
Early Ambulation
;
Emergency Service, Hospital
;
Fatigue
;
Femur Neck
;
Femur
;
Fractures, Stress
;
Humans
;
Lower Extremity
;
Military Personnel
;
Physical Examination
;
Radiography
;
Wounds and Injuries
;
Young Adult
7.Quality of information on the Internet for Korean patients with inflammatory bowel disease
Jun Sik YOON ; Sang Jik LEE ; Eun Soo KIM ; Sung Kook KIM ; Min Kyu JUNG ; Hyun Seok LEE ; Yong Hwan KWON ; Su Youn NAM ; Seong Woo JEON ; Sun JIN ; Joon Seop LEE ; Seong Jae YEO
The Korean Journal of Internal Medicine 2019;34(6):1215-1222
BACKGROUND/AIMS:
The Internet is the main resource for health-related information. The incidence of inflammatory bowel disease (IBD) is rapidly increasing in Asian countries. However, the quality of websites for IBD available in this region has not been evaluated. We aimed to evaluate the quality of the information on IBD obtained from Korean websites.
METHODS:
Using the terms “Crohn’s disease†or “ulcerative colitis,†websites were selected from those obtained with the three most renowned search engines in Korea; 60 websites from the results of each engine were chosen. The websites were classified into institutional, commercial, charitable, supportive, or alternative medicine types according to the characteristics of each site. The websites were evaluated regarding content quality using the validated DISCERN instrument and the Journal of the American Medical Association benchmarks.
RESULTS:
The median score of all the websites according to the DISCERN instrument was 32 (interquartile range, 25 to 47) out of 80, indicating an insufficient overall quality of information. The alternative medicine sites scored the lowest, whereas the institutional sites scored the highest (p < 0.05). The quality of information was significantly different among the search engines (p = 0.028). The rank of appearance in the Google search result did not correlate with the quality level of the information.
CONCLUSIONS
The quality of information on the Internet regarding IBD varied according to the website type and search engine. Accreditation and quality assurance systems should be implemented for websites to ensure that the public and patients obtain accurate information on IBD.
8.Study Protocol of Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Microcarcinoma (MAeSTro).
Jae Hoon MOON ; Ji hoon KIM ; Eun Kyung LEE ; Kyu Eun LEE ; Sung Hye KONG ; Yeo Koon KIM ; Woo jin JUNG ; Chang Yoon LEE ; Roh Eul YOO ; Yul HWANGBO ; Young Shin SONG ; Min Joo KIM ; Sun Wook CHO ; Su jin KIM ; Eun Jae JUNG ; June Young CHOI ; Chang Hwan RYU ; You Jin LEE ; Jeong Hun HAH ; Yuh Seog JUNG ; Junsun RYU ; Yunji HWANG ; Sue K PARK ; Ho Kyung SUNG ; Ka Hee YI ; Do Joon PARK ; Young Joo PARK
Endocrinology and Metabolism 2018;33(2):278-286
BACKGROUND: The ongoing Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Microcarcinoma (MAeSTro) aims to observe the natural course of papillary thyroid microcarcinoma (PTMC), develop a protocol for active surveillance (AS), and compare the long-term prognosis, quality of life, and medical costs between the AS and immediate surgery groups. METHODS: This multicenter prospective cohort study of PTMC started in June 2016. The inclusion criteria were suspicious of malignancy or malignancy based on fine needle aspiration or core needle biopsy, age of ≥18 years, and a maximum diameter of ≤1 cm. If there was no major organ involvement, no lymph node/distant metastasis, and no variants with poor prognosis, the patients were explained of the pros and cons of immediate surgery and AS before selecting AS or immediate surgery. Follow-up visits (physical examination, ultrasonography, thyroid function, and questionnaires) are scheduled every 6 months during the first 2 years, and then every 1 year thereafter. Progression was defined as a maximum diameter increase of ≥3, ≥2 mm in two dimensions, suspected organ involvement, or lymph node/distant metastasis. RESULTS: Among 439 enrolled patients, 290 patients (66.1%) chose AS and 149 patients (33.9%) chose immediate surgery. The median follow-up was 6.7 months (range, 0.2 to 11.9). The immediate surgery group had a larger maximum tumor diameter, compared to the AS group (7.1±1.9 mm vs. 6.6±2.0 mm, respectively; P=0.014). CONCLUSION: The results will be useful for developing an appropriate PTMC treatment policy based on its natural course and risk factors for progression.
Biopsy, Fine-Needle
;
Biopsy, Large-Core Needle
;
Cohort Studies*
;
Follow-Up Studies
;
Humans
;
Neoplasm Metastasis
;
Prognosis
;
Prospective Studies*
;
Quality of Life
;
Risk Factors
;
Thyroid Gland*
;
Thyroid Neoplasms
;
Ultrasonography
9.Corrigendum: Study Protocol of Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Microcarcinoma (MAeSTro).
Jae Hoon MOON ; Ji Hoon KIM ; Eun Kyung LEE ; Kyu Eun LEE ; Sung Hye KONG ; Yeo Koon KIM ; Woo Jin JEONG ; Chang Yoon LEE ; Roh Eul YOO ; Yul HWANGBO ; Young Shin SONG ; Min Joo KIM ; Sun Wook CHO ; Su Jin KIM ; Eun Jae CHUNG ; June Young CHOI ; Chang Hwan RYU ; You Jin LEE ; Jeong Hun HAH ; Yuh Seog JUNG ; Junsun RYU ; Yunji HWANG ; Sue K PARK ; Ho Kyung SUNG ; Ka Hee YI ; Do Joon PARK ; Young Joo PARK
Endocrinology and Metabolism 2018;33(3):427-427
No abstract available.
10.Measurement of Angle Kappa Using Ultrasound Biomicroscopy and Corneal Topography.
Joon Hyung YEO ; Nam Ju MOON ; Jeong Kyu LEE
Korean Journal of Ophthalmology 2017;31(3):257-262
PURPOSE: To introduce a new convenient and accurate method to measure the angle kappa using ultrasound biomicroscopy (UBM) and corneal topography. METHODS: Data from 42 eyes (13 males and 29 females) were analyzed in this study. The angle kappa was measured using Orbscan II and calculated with UBM and corneal topography. The angle kappa of the dominant eye was compared with measurements by Orbscan II. RESULTS: The mean patient age was 36.4 ± 13.8 years. The average angle kappa measured by Orbscan II was 3.98°± 1.12°, while the average angle kappa calculated with UBM and corneal topography was 3.19°± 1.15°. The difference in angle kappa measured by the two methods was statistically significant (p < 0.001). The two methods showed good reliability (intraclass correlation coefficient, 0.671; p < 0.001). Bland-Altman plots were used to demonstrate the agreement between the two methods. CONCLUSIONS: We designed a new method using UBM and corneal topography to calculate the angle kappa. This method is convenient to use and allows for measurement of the angle kappa without an expensive device.
Corneal Topography*
;
Humans
;
Male
;
Methods
;
Microscopy, Acoustic*
;
Ultrasonography*

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