1.Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 study
Jie-Hyun KIM ; Hwoon-Yong JUNG ; In Kyung YOO ; Seon-Young PARK ; Jae Gyu KIM ; Jae Kyu SUNG ; Jin Seok JANG ; Gab Jin CHEON ; Kyoung Oh KIM ; Tae Oh KIM ; Soo Teik LEE ; Kwang Bum CHO ; Hoon Jai CHUN ; Jong-Jae PARK ; Moo In PARK ; Jae-Young JANG ; Seong Woo JEON ; Jin Woong CHO ; Dae Hwan KANG ; Gwang Ha KIM ; Jae J. KIM ; Sang Gyun KIM ; Nayoung KIM ; Yong Chan LEE ; Su Jin HONG ; Hyun-Soo KIM ; Sora LEE ; Sang Woo LEE
Gut and Liver 2024;18(1):70-76
Background/Aims:
H2 receptor antagonists (H2RA) have been used to treat gastritis by inhibiting gastric acid. Proton pump inhibitors (PPIs) are more potent acid suppressants than H2RA.However, the efficacy and safety of low-dose PPI for treating gastritis remain unclear. The aim was to investigate the efficacy and safety of low-dose PPI for treating gastritis.
Methods:
A double-blind, noninferiority, multicenter, phase 3 clinical trial randomly assigned 476 patients with endoscopic erosive gastritis to a group using esomeprazole 10 mg (DW1903) daily and a group using famotidine 20 mg (DW1903R1) daily for 2 weeks. The full-analysis set included 319 patients (DW1903, n=159; DW1903R1, n=160) and the per-protocol set included 298 patients (DW1903, n=147; DW1903R1, n=151). The primary endpoint (erosion improvement rate) and secondary endpoint (erosion and edema cure rates, improvement rates of hemorrhage, erythema, and symptoms) were assessed after the treatment. Adverse events were compared.
Results:
According to the full-analysis set, the erosion improvement rates in the DW1903 and DW1903R1 groups were 59.8% and 58.8%, respectively. According to the per-protocol analysis, the erosion improvement rates in the DW1903 and DW1903R1 groups were 61.9% and 59.6%, respectively. Secondary endpoints were not significantly different between two groups except that the hemorrhagic improvement rate was higher in DW1903 with statistical tendency. The number of adverse events were not statistically different.
Conclusions
DW1903 of a low-dose PPI was not inferior to DW1903R1 of H2RA. Thus, lowdose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756).
2.Transradial Versus Transfemoral Access for Bifurcation Percutaneous Coronary Intervention Using SecondGeneration Drug-Eluting Stent
Jung-Hee LEE ; Young Jin YOUN ; Ho Sung JEON ; Jun-Won LEE ; Sung Gyun AHN ; Junghan YOON ; Hyeon-Cheol GWON ; Young Bin SONG ; Ki Hong CHOI ; Hyo-Soo KIM ; Woo Jung CHUN ; Seung-Ho HUR ; Chang-Wook NAM ; Yun-Kyeong CHO ; Seung Hwan HAN ; Seung-Woon RHA ; In-Ho CHAE ; Jin-Ok JEONG ; Jung Ho HEO ; Do-Sun LIM ; Jong-Seon PARK ; Myeong-Ki HONG ; Joon-Hyung DOH ; Kwang Soo CHA ; Doo-Il KIM ; Sang Yeub LEE ; Kiyuk CHANG ; Byung-Hee HWANG ; So-Yeon CHOI ; Myung Ho JEONG ; Hyun-Jong LEE
Journal of Korean Medical Science 2024;39(10):e111-
Background:
The benefits of transradial access (TRA) over transfemoral access (TFA) for bifurcation percutaneous coronary intervention (PCI) are uncertain because of the limited availability of device selection. This study aimed to compare the procedural differences and the in-hospital and long-term outcomes of TRA and TFA for bifurcation PCI using secondgeneration drug-eluting stents (DESs).
Methods:
Based on data from the Coronary Bifurcation Stenting Registry III, a retrospective registry of 2,648 patients undergoing bifurcation PCI with second-generation DES from 21 centers in South Korea, patients were categorized into the TRA group (n = 1,507) or the TFA group (n = 1,141). After propensity score matching (PSM), procedural differences, in-hospital outcomes, and device-oriented composite outcomes (DOCOs; a composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) were compared between the two groups (772 matched patients each group).
Results:
Despite well-balanced baseline clinical and lesion characteristics after PSM, the use of the two-stent strategy (14.2% vs. 23.7%, P = 0.001) and the incidence of in-hospital adverse outcomes, primarily driven by access site complications (2.2% vs. 4.4%, P = 0.015), were significantly lower in the TRA group than in the TFA group. At the 5-year follow-up, the incidence of DOCOs was similar between the groups (6.3% vs. 7.1%, P = 0.639).
Conclusion
The findings suggested that TRA may be safer than TFA for bifurcation PCI using second-generation DESs. Despite differences in treatment strategy, TRA was associated with similar long-term clinical outcomes as those of TFA. Therefore, TRA might be the preferred access for bifurcation PCI using second-generation DES.
3.Postoperative Prognostic Predictors of Bile Duct Cancers: Clinical Analysis and Immunoassays of Tissue Microarrays
Hwe Hoon CHUNG ; Seung Hee SEO ; Hyemin KIM ; Yuil KIM ; Dong Wuk KIM ; Kwang Hyuck LEE ; Kyu Taek LEE ; Jin Seok HEO ; In Woong HAN ; Seon Mee PARK ; Kee-Taek JANG ; Jong Kyun LEE ; Joo Kyung PARK
Gut and Liver 2023;17(1):159-169
Background/Aims:
Cholangiocarcinoma frequently recurs even after curative resection. Expression levels of proteins such as epidermal growth factor receptor (EGFR), Snail, epithelial cadherin (E-cadherin), and interleukin-6 (IL-6) examined by immunohistochemistry have been studied as potential prognostic factors for cholangiocarcinoma. The aim of this study was to investigate significant factors affecting the prognosis of resectable cholangiocarcinoma.
Methods:
Ninety-one patients who underwent surgical resection at Samsung Medical Center for cholangiocarcinoma from 1995 to 2013 were included in this study. Expression levels of Ecadherin, Snail, IL-6, membranous EGFR, and cytoplasmic EGFR were analyzed by immunohistochemistry using tissue microarray blocks made from surgical specimens.
Results:
Patients with high levels of membranous EGFR in tissue microarrays had significantly shorter overall survival (OS) and disease-free survival (DFS): high membranous EGFR (score 0–2) 38.0 months versus low membranous EGFR (score 3) 14.4 months (p=0.008) and high membranous EGFR (score 0–2) 23.2 months versus low membranous EGFR (score 3) 6.1 months (p=0.004), respectively. On the other hand, E-cadherin, Snail, cytoplasmic EGFR, and IL-6 did not show significant association with OS or DFS. Patients with distant metastasis had significantly higher IL-6 levels than those with locoregional recurrence (p=0.01).
Conclusions
This study showed that overexpression of membranous EGFR was significantly associated with shorter OS and DFS in surgically resected bile duct cancer patients. In addition, higher IL-6 expression was a predictive marker for recurrence in cholangiocarcinoma patients with distant organ metastasis after surgical resection.
4.Erratum: Correction of Affiliations in the Article “Establishment of a Nationwide Korean Imaging Cohort of Coronavirus Disease 2019”
Soon Ho YOON ; Soo-Youn HAM ; Bo Da NAM ; Kum Ju CHAE ; Dabee LEE ; Jin Young YOO ; So Hyeon BAK ; Jin Young KIM ; Jin Hwan KIM ; Ki Beom KIM ; Jung Im JUNG ; Jae-Kwang LIM ; Jong Eun LEE ; Myung Jin CHUNG ; Young Kyung LEE ; Young Seon KIM ; Ji Eun JO ; Sang Min LEE ; Woocheol KWON ; Chang Min PARK ; Yun-Hyeon KIM ; Yeon Joo JEONG
Journal of Korean Medical Science 2023;38(34):e298-
5.On-demand Versus Continuous Maintenance Treatment With a Proton Pump Inhibitor for Mild Gastroesophageal Reflux Disease: A Prospective Randomized Multicenter Study
Da Hyun JUNG ; Young Hoon YOUN ; Hye-Kyung JUNG ; Seung Young KIM ; Cheal Wung HUH ; Cheol Min SHIN ; Jung-Hwan OH ; Kyu Chan HUH ; Moo In PARK ; Suck Chei CHOI ; Ki Bae KIM ; Seon-Young PARK ; Joong Goo KWON ; Yu Kyung CHO ; Jung Ho PARK ; Jeong Eun SHIN ; Eun Jeong GONG ; Jae Hak KIM ; Su Jin HONG ; Hyun Jin KIM ; Sam Ryong JEE ; Ju Yup LEE ; Kee Wook JUNG ; Hee Man KIM ; Kwang Jae LEE
Journal of Neurogastroenterology and Motility 2023;29(4):460-469
Background/Aims:
It remains unclear which maintenance treatment modality is most appropriate for mild gastroesophageal reflux disease (GERD).We aimed to compare on-demand treatment with continuous treatment using a proton pump inhibitor (PPI) in the maintenance treatment for patients with non-erosive GERD or mild erosive esophagitis.
Methods:
Patients whose GERD symptoms improved after 4 weeks of standard dose PPI treatment were prospectively enrolled at 25 hospitals.Subsequently, the enrolled patients were randomly assigned to either an on-demand or a continuous maintenance treatment group, and followed in an 8-week interval for up to 24 weeks.
Results:
A total of 304 patients were randomized to maintenance treatment (continuous, n = 151 vs on-demand, n = 153). The primary outcome, the overall proportion of unwillingness to continue the assigned maintenance treatment modality, failed to confirm the noninferiority of on-demand treatment (45.9%) compared to continuous treatment (36.1%). Compared with the on-demand group, the GERD symptom and health-related quality of life scores significantly more improved and the overall satisfaction score was significantly higher in the continuous treatment group, particularly at week 8 and week 16 of maintenance treatment. Work impairment scores were not different in the 2 groups, but the prescription cost was less in the on-demand group. Serum gastrin levels significantly elevated in the continuous treatment group, but not in the on-demand group.
Conclusions
Continuous treatment seems to be more appropriate for the initial maintenance treatment of non-erosive GERD or mild erosive esophagitis than on-demand treatment. Stepping down to on-demand treatment needs to be considered after a sufficient period of continuous treatment.
6.The current status and outcomes of in-hospital P2Y12 receptor inhibitor switching in Korean patients with acute myocardial infarction
Keun-Ho PARK ; Myung Ho JEONG ; Hyun Kuk KIM ; Young-Jae KI ; Sung Soo KIM ; Youngkeun AHN ; Hyun Yi KOOK ; Hyo-Soo KIM ; Hyeon Cheol GWON ; Ki Bae SEUNG ; Seung Woon RHA ; Shung Chull CHAE ; Chong Jin KIM ; Kwang Soo CHA ; Jong Seon PARK ; Jung Han YOON ; Jei Keon CHAE ; Seung Jae JOO ; Dong-Joo CHOI ; Seung Ho HUR ; In Whan SEONG ; Myeong Chan CHO ; Doo Il KIM ; Seok Kyu OH ; Tae Hoon AHN ; Jin Yong HWANG ;
The Korean Journal of Internal Medicine 2022;37(2):350-365
Background/Aims:
While switching strategies of P2Y12 receptor inhibitors (RIs) have sometimes been used in acute myocardial infarction (AMI) patients, the current status of in-hospital P2Y12RI switching remains unknown.
Methods:
Overall, 8,476 AMI patients who underwent successful revascularization from Korea Acute Myocardial Infarction Registry-National Institute of Health (KAMIR-NIH) were divided according to in-hospital P2Y12RI strategies, and net adverse cardiovascular events (NACEs), defined as a composite of cardiac death, non-fatal myocardial infarction (MI), stroke, or thrombolysis in myocardial infarction (TIMI) major bleeding during hospitalization were compared.
Results:
Patients with in-hospital P2Y12RI switching accounted for 16.5%, of which 867 patients were switched from clopidogrel to potent P2Y12RI (C-P) and 532 patients from potent P2Y12RI to clopidogrel (P-C). There were no differences in NACEs among the unchanged clopidogrel, the unchanged potent P2Y12RIs, and the P2Y12RI switching groups. However, compared to the unchanged clopidogrel group, the C-P group had a higher incidence of non-fatal MI, and the P-C group had a higher incidence of TIMI major bleeding. In clinical events of in-hospital P2Y12RI switching, 90.9% of non-fatal MI occurred during pre-switching clopidogrel administration, 60.7% of TIMI major bleeding was related to pre-switching P2Y12RIs, and 71.4% of TIMI major bleeding was related to potent P2Y12RIs. Only 21.6% of the P2Y12RI switching group switched to P2Y12RIs after a loading dose (LD); however, there were no differences in clinical events between patients with and without LD.
Conclusions
In-hospital P2Y12RI switching occurred occasionally, but had relatively similar clinical outcomes compared to unchanged P2Y12RIs in Korean AMI patients. Non-fatal MI and bleeding appeared to be mainly related to pre-switching P2Y12RIs.
7.2020 Korean Emergency Physician Survey
Seon Koo KIM ; 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 ; Hyung Min LEE ; Soon Joo WANG
Journal of the Korean Society of Emergency Medicine 2022;33(4):1-10
Objective:
This study was carried out to establish a basis for understanding and correcting the problems of the emergency physicians (EP) in Korea by examining the current status through the 2020 emergency physician survey conducted by the Korean Society of Emergency Medicine (KSEM).
Methods:
An online survey was conducted from January 15 to February 26, 2021, through a website and mobile application. The final questionnaire was classified into three types based on the clinical work in the emergency department (ED), current position, and the year of board certification. The contents of the questionnaire were organized into eight themes, and a subcommittee was put in charge of each.
Results:
Of the 400 emergency medical institutions surveyed, 295 hospitals (74.2%) had board-certified EPs, and 1,453 EPs (72.5%) out of 2,000 were working in the ED. Of these, on average, 7.2 EPs worked together, and they worked 11.6 days/153.1 hours per month and did night shifts 5.9 days per month. 30.7% showed excessive sleepiness during the day, and only 9.6% said that they could adhere to mealtimes. 27.1% responded that they suffered from depression. The level of satisfaction was 3.2 points, and 43.0% responded that they would choose emergency medicine (EM) again as their major. The most important factor in choosing EM was the availability of adequate free time. Their responses indicated that the retirement age was 59.7 years, and the upper age limit for the night shift was 54.3 years.
Conclusion
Though there have been improvements since the first survey in 2010, there was no notable increase in EP satisfaction. Therefore, appropriate future policies should be formulated and implemented based on these survey results.
8.2020 Korean Emergency Physician Survey
Seon Koo KIM ; 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 CHO ; In Hwan YEO ; Ji Hun KANG ; Woo Jin JUNG ; Dae Sung LIM ; Eu Sun LEE ; Hyung Min LEE ; Soon Joo WANG
Journal of the Korean Society of Emergency Medicine 2022;33(5):520-520
9.Efficacy and safety of rapid intermittent bolus compared with slow continuous infusion in patients with severe hypernatremia (SALSA II trial): a study protocol for a randomized controlled trial
Ji Young RYU ; Songuk YOON ; Jeonghwan LEE ; Sumin BAEK ; You Hwan JO ; Kwang-Pil KO ; Jin-ah SIM ; Junhee HAN ; Sejoong KIM ; Seon Ha BAEK
Kidney Research and Clinical Practice 2022;41(4):508-520
Hypernatremia is a common electrolyte disorder in children and elderly people and has high short-term mortality. However, no high-quality studies have examined the correction rate of hypernatremia and the amount of fluid required for correction. Therefore, in this study, we will compare the efficacy and safety of rapid intermittent bolus (RIB) and slow continuous infusion (SCI) of electrolyte-free solution in hypernatremia treatment. Methods: This is a prospective, investigator-initiated, multicenter, open-label, randomized controlled study with two experimental groups. A total of 166 participants with severe hypernatremia will be enrolled and divided into two randomized groups; both the RIB and SCI groups will be managed with electrolyte-free water. We plan to infuse the same amount of fluid to both groups, for 1 hour in the RIB group and continuously in the SCI group. The primary outcome is a rapid decrease in serum sodium levels within 24 hours. The secondary outcomes will further compare the efficacy and safety of the two treatment protocols. Conclusion: This is the first randomized controlled trial to evaluate the efficacy and safety of RIB correction compared with SCI in adult patients with severe hypernatremia.
10.Laboratory information management system for COVID-19 non-clinical efficacy trial data
Suhyeon YOON ; Hyuna NOH ; Heejin JIN ; Sungyoung LEE ; Soyul HAN ; Sung-Hee KIM ; Jiseon KIM ; Jung Seon SEO ; Jeong Jin KIM ; In Ho PARK ; Jooyeon OH ; Joon-Yong BAE ; Gee Eun LEE ; Sun-Je WOO ; Sun-Min SEO ; Na-Won KIM ; Youn Woo LEE ; Hui Jeong JANG ; Seung-Min HONG ; Se-Hee AN ; Kwang-Soo LYOO ; Minjoo YEOM ; Hanbyeul LEE ; Bud JUNG ; Sun-Woo YOON ; Jung-Ah KANG ; Sang-Hyuk SEOK ; Yu Jin LEE ; Seo Yeon KIM ; Young Been KIM ; Ji-Yeon HWANG ; Dain ON ; Soo-Yeon LIM ; Sol Pin KIM ; Ji Yun JANG ; Ho LEE ; Kyoungmi KIM ; Hyo-Jung LEE ; Hong Bin KIM ; Jun Won PARK ; Dae Gwin JEONG ; Daesub SONG ; Kang-Seuk CHOI ; Ho-Young LEE ; Yang-Kyu CHOI ; Jung-ah CHOI ; Manki SONG ; Man-Seong PARK ; Jun-Young SEO ; Ki Taek NAM ; Jeon-Soo SHIN ; Sungho WON ; Jun-Won YUN ; Je Kyung SEONG
Laboratory Animal Research 2022;38(2):119-127
Background:
As the number of large-scale studies involving multiple organizations producing data has steadily increased, an integrated system for a common interoperable format is needed. In response to the coronavirus disease 2019 (COVID-19) pandemic, a number of global efforts are underway to develop vaccines and therapeutics. We are therefore observing an explosion in the proliferation of COVID-19 data, and interoperability is highly requested in multiple institutions participating simultaneously in COVID-19 pandemic research.
Results:
In this study, a laboratory information management system (LIMS) approach has been adopted to systemically manage various COVID-19 non-clinical trial data, including mortality, clinical signs, body weight, body temperature, organ weights, viral titer (viral replication and viral RNA), and multiorgan histopathology, from multiple institutions based on a web interface. The main aim of the implemented system is to integrate, standardize, and organize data collected from laboratories in multiple institutes for COVID-19 non-clinical efficacy testings. Six animal biosafety level 3 institutions proved the feasibility of our system. Substantial benefits were shown by maximizing collaborative high-quality non-clinical research.
Conclusions
This LIMS platform can be used for future outbreaks, leading to accelerated medical product development through the systematic management of extensive data from non-clinical animal studies.

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