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.A study on the characteristics of elderly patients with respiratory symptoms who visited the emergency department
Jinwoo HONG ; Hui Jai LEE ; Jongwhan SHIN ; Kyoung Min YOU
Journal of the Korean Society of Emergency Medicine 2024;35(2):109-123
Objective:
With the increase in the elderly population worldwide, there has been a corresponding increase in the proportion of elderly patients who visit the emergency department (ED). Therefore, research on the elderly not only aids in the treatment of diseases but also assists in the efficient utilization of limited medical resources. Respiratory symptoms are one of the most common and sometimes life-threatening symptoms in elderly patients. Knowing the factors that can predict the prognosis in advance can help with rapid diagnosis and immediate treatment.
Methods:
A retrospective study was conducted from September 2019 to March 2020 at an ED in an urban area. Patients with respiratory symptoms who were treated in the critical care area of the ED were reviewed. The ED clinical data were compared with the outcomes in the ED.
Results:
A total of 750 patients were screened, of which 703 were elderly patients. Many clinical factors showed variations between the elderly and non-elderly patients. Oxygen volume, elevated lactate level, elevated troponin level, hypocalcemia, and hypothermia were related with ED death or ICU admission among the elderly.
Conclusion
We identified several clinical factors with respect to elderly ED patients with respiratory symptoms that were related to the clinical outcomes and can be used for decision-making and prediction of poor outcomes.
3.Clinical significance of hemoglobin decrease in emergency department elderly hip fracture patients
Hyemin PARK ; Hui Jai LEE ; Soong Joon LEE ; Jongwhan SHIN ; Kyoung Min YOU
Journal of the Korean Society of Emergency Medicine 2023;34(3):276-285
Objective:
Decreases in the hemoglobin level compared to the pre-injury lab results are often observed in patients with elderly hip fractures visiting the emergency department (ED). This decrease could be the outcome of the fracture itself or a complication caused by comorbidities. This study examined whether significant hemoglobin decreases, as detected in the ED, are related to other-than-hip-fracture bleeding focus or clinical outcomes.
Methods:
The electronic medical records were reviewed retrospectively at a single university ED from January 2012 to March 2019. ED diagnoses of hip fractures were screened and enrolled if the patient was 60 years or older and had hemoglobin levels recorded within the previous 6 months. A significant decrease in the hemoglobin level is defined as more than 2 g/dL.
Results:
Three hundred patients were enrolled in this study. Significant hemoglobin decreases were apparent in 43 patients (14.3%). Only four patients (1.3%) had an other-than-hip-fracture bleeding focus. One of those had a significant hemoglobin decrease. In a “significant decrease” versus “non-significant decrease” intergroup comparison, length of hospital stays (median and interquartile range: 17.0 [15.0-21.5] vs. 17.0 [12.0-21.0], P=0.55), survival discharge (4.7% vs. 2.3%, P=0.72), and other-than-hip-fracture bleeding focus (2.3% vs. 1.2%, P>0.99) did not differ significantly.
Conclusion
A decrease in hemoglobin level is common among elderly hip fracture patients. On the other hand, the incidence of other-than-hip-fracture bleeding focus was rare and unrelated to a decrease in significant hemoglobin levels. Similarly, neither the hospital length of stay nor survival discharge was unrelated to the hemoglobin level decrease.
4.Efficacy and safety of intragastric balloon for obesity in Korea
Kwang Gyun LEE ; Seung-Joo NAM ; Hyuk Soon CHOI ; Hang Lak LEE ; Jai Hoon YOON ; Chan Hyuk PARK ; Kyoung Oh KIM ; Do Hoon KIM ; Jung-Wook KIM ; Won SOHN ; Sung Hoon JUNG ;
Clinical Endoscopy 2023;56(3):333-339
Background/Aims:
Intragastric balloon (IGB) is the only available endoscopic bariatric and metabolic therapy in Korea. End-ball (Endalis) has the longest history of clinical use among the IGBs available in Korea. However, little clinical data on this system have been reported. In this study, we aimed to evaluate the efficacy and safety of End-ball in Korea.
Methods:
We performed a retrospective cohort study of patients who underwent IGB insertion (End-ball) from 2013 to 2019. Demographic and anthropometric data were collected. The efficacy and safety of IGB treatment were analyzed.
Results:
In total, 80 patients were included. Mean age was 33.7 years and 83.8% were female. Initial body mass index was 34.48±4.69 kg/m2. Body mass index reduction was 3.72±2.63 kg/m2 at the time of IGB removal. Percent of total body weight loss (%TBWL) was 10.76%±6.76%. Percentage excess body weight loss was 43.67%±27.59%. Most adverse events were minor, and 71.4% of participants showed nausea, vomiting, or abdominal pain.
Conclusions
IGB treatment showed good efficacy and safety profile in Korean patients with obesity. In terms of %TBWL and percentage excess body weight loss, the efficacy was similar to that in the Western population.
5.Clinical predictors of the positive brain magnetic resonance imaging finding in patients with acute altered mental status in the emergency department
Narae KIM ; Kyoung Min YOU ; Jonghwan SHIN ; Hui Jai LEE
Journal of the Korean Society of Emergency Medicine 2023;34(2):166-176
Objective:
This study aimed to determine the clinical factors associated with positive brain magnetic resonance imaging (MRI) findings in patients presenting to the emergency department (ED) with acute altered mental status (AMS).
Methods:
Patients with acute AMS who presented to the ED were retrospectively analyzed from September 2019 to March 2020. Non-traumatic patients with abnormal alert, verbal, pain, unresponsive (AVPU) scale scores and exhibiting acute change in mental status were included in the study. We evaluated the clinical characteristics of patients with acute AMS according to the results of their brain MRI. A multivariable logistic regression model was used to determine the clinical factors associated with positive brain MRI findings.
Results:
During the study period, 138 patients underwent brain MRI in the ED, with 36 (26.1%) positive results. A majority of patients with positive brain MRI findings had underlying malignancies, cerebrovascular disease, higher serum total bicarbonate (TCO2) levels, TCO2≥22 mmol/L, lower blood urea nitrogen levels, abnormal findings on brain computed tomography and abnormal findings on neurologic examination. In the multivariable analysis, serum TCO2≥22 mmol/L (odds ratio [OR], 2.12; 95% confidence interval [CI], 1.09-4.12) and the presence of cranial nerve abnormalities (OR, 3.88; 95% CI, 1.55-9.68) and extremity abnormalities (OR, 2.76; 95% CI, 1.11-6.88) were significantly associated with positive brain MRI results.
Conclusion
Serum TCO2 level and the presence of cranial nerve and extremity abnormalities in the neurologic examinations were significantly associated with positive brain MRI results in patients with acute AMS.
6.Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial
Yoon Jin CHOI ; Yong Chan LEE ; Jung Mogg KIM ; Jin Il KIM ; Jeong Seop MOON ; Yun Jeong LIM ; Gwang Ho BAIK ; Byoung Kwan SON ; Hang Lak LEE ; Kyoung Oh KIM ; Nayoung KIM ; Kwang Hyun KO ; Hye-Kyung JUNG ; Ki-Nam SHIM ; Hoon Jai CHUN ; Byung-Wook KIM ; Hyuk LEE ; Jie-Hyun KIM ; Hyunsoo CHUNG ; Sang Gyun KIM ; Jae Young JANG
Gut and Liver 2022;16(4):535-546
Background/Aims:
We examined the efficacy and safety of tegoprazan as a part of first-line triple therapy for Helicobacter pylori eradication.
Methods:
A randomized, double-blind, controlled, multicenter study was performed to evaluate whether tegoprazan (50 mg)-based triple therapy (TPZ) was noninferior to lansoprazole (30 mg)-based triple therapy (LPZ) (with amoxicillin 1 g and clarithromycin 500 mg; all administered twice daily for 7 days) for treating H. pylori. The primary endpoint was the H. pylori eradication rate. Subgroup analyses were performed according to the cytochrome P450 (CYP) 2C19 genotype, the minimum inhibitory concentration (MIC) of amoxicillin and clarithromycin, and underlying gastric diseases.
Results:
In total, 350 H. pylori-positive patients were randomly allocated to the TPZ or LPZ group. The H. pylori eradication rates in the TPZ and LPZ groups were 62.86% (110/175) and 60.57% (106/175) in an intention-to-treat analysis and 69.33% (104/150) and 67.33% (101/150) in a per-protocol analysis (non-inferiority test, p=0.009 and p=0.013), respectively. Subgroup analyses according to MICs or CYP2C19 did not show remarkable differences in eradication rate. Both first-line triple therapies were well-tolerated with no notable differences.
Conclusions
TPZ is as effective as proton pump inhibitor-based triple therapy and is as safe as first-line H. pylori eradication therapy but does not overcome the clarithromycin resistance of H. pylori in Korea
7.Renal Infarction in Vascular Ehlers-Danlos Syndrome
Hea Ran LEE ; Si Chan KIM ; Eun Hye YANG ; Su Yun JUNG ; Jai Won CHANG ; Eun Kyoung LEE
Korean Journal of Medicine 2022;97(4):271-276
Renal infarction is a condition caused by sudden disturbance of renal arterial blood flow, which occurs frequently in cardioembolic disease, renal artery injury (trauma, Marfan syndrome, rarely Ehlers-Danlos syndrome), and in association with a hypercoagulable state. Ehlers-Danlos syndrome is a rare hereditary connective tissue disease characterized by skin fragility, hyperelasticity, hypermobility of small joints, and easy bruising. Among the subtypes, vascular Ehlers-Danlos syndrome is a very rare genetic disease caused by a mutation in the COL3A1 gene. As blood vessels are fragile due dysfunctional collagen synthesis, complications of bleeding due to arterial dissection or rupture are common in patients with this disease. Here, we report a case of vascular Ehlers-Danlos syndrome diagnosed based on a renal infarction caused by thrombus and renal artery injury; we also present a review of the relevant literature.
8.Factors in early hospital arrival following suspected acute stroke symptoms
Dong Hyeob HAN ; Jonghwan SHIN ; Jin Hee JUNG ; Kyoung Jun SONG ; Hui Jai LEE ; Kyoung Min YOU
Journal of the Korean Society of Emergency Medicine 2022;33(5):436-447
Objective:
We investigated the factors that affect the time from the onset of acute stroke symptoms to arrival at the emergency department (ED).
Methods:
Between July 2019 and February 2020, patients with acute stroke symptoms who visited a public hospital were evaluated by retrospective analysis using a prospective survey. The data for this study was gathered from baseline interviews with patients enrolled in stroke surveys. The primary outcome was time to arrival at the ED, evaluated as a binary variable with a value of 4.5 hours.
Results:
Overall, 205 patients were included in the final analysis. Among them, 47% (n=96) of patients with acute stroke symptoms arrived at the ED later than 4.5 hours from the time of onset of acute stroke symptoms. After multivariable logistic regression analyses, it was found that patients with higher National Institutes of Health Stroke Scale (NIHSS) scores, patients who did not live with their family members, and patients who were found by a passerby were associated with early ED arrival post onset of acute stroke symptoms. Among patients diagnosed with acute stroke, those with higher NIHSS scores or underlying malignant diseases were found to present earlier at the ED.
Conclusion
Approximately half of the patients (47%) with acute stroke symptoms presented to the ED within 4.5 hours. Higher NIHSS scores and the presence of underlying malignancy were identified as the key factors that were associated with an early presentation at the ED from the time of onset of acute stroke.
9.Outcomes after liver transplantation in Korea: Incidence and risk factors from Korean transplantation registry
Jong Man KIM ; Deok Gie KIM ; Jihyun KIM ; Keunsung LEE ; Kwang-Woong LEE ; Je Ho RYU ; Bong-Wan KIM ; Dong Lak CHOI ; Young Kyoung YOU ; Dong-Sik KIM ; Yang Won NAH ; Koo Jeong KANG ; Jai Young CHO ; Geun HONG ; Hee Chul YU ; Ju Ik MOON ; Dongho CHOI ; Shin HWANG ; Myoung Soo KIM
Clinical and Molecular Hepatology 2021;27(3):451-462
Background/Aims:
To analyze the incidence and risk factors of outcomes after liver transplantation (LT) in the Korean population.
Methods:
This study analyzed data from the liver cohort of Korean Organ Transplantation Registry (KOTRY) who had LT between May 2014 and December 2017. Study measures included the incidence of post-LT outcomes in recipients of living donor LT (LDLT) and deceased donor LT (DDLT). Cox multivariate proportional hazards model was used to determine the potential risk factors predicting the outcomes.
Results:
A total of 2,563 adult recipients with LT (LDLT, n=1,956; DDLT, n=607) were included, with mean±standard deviation age of 53.9±8.9 years, and 72.2% were male. The post-LT outcomes observed in each LDLT and DDLT recipients were death (4.0% and 14.7%), graft loss (5.0% and 16.1%), rejection (7.0% and 12.0%), renal failure (2.7% and 13.8%), new onset of diabetes (12.5% and 15.4%), and hepatocellular carcinoma (HCC) recurrence (both 6.7%). In both LDLT and DDLT recipients, the most common post-LT complications were renal dysfunction (33.6% and 51.4%), infection (26.7% and 48.4%), and surgical complication (22.5% and 23.9%). Incidence of these outcomes were generally higher among recipients of DDLT than LDLT. Multivariate analysis indicated recipient age and DDLT as significant risk factors associated with death and graft loss. DDLT and ABO incompatible transplant were prognostic factors for rejection, and HCC beyond Milan criteria at pre-transplant was a strong predictor of HCC recurrence.
Conclusions
This study is a good indicator of the post-LT prognosis in the Korean population and suggests a significant burden of post-LT complications.
10.Dedicated Cold Snare vs. Traditional Snare for Polypectomy of Diminutive and Small Lesions in a Porcine Model: A Research Group for Endoscopic Instruments and Stents (REIS) Study
Han Hee LEE ; Bo-In LEE ; Jung-Wook KIM ; Hyun LIM ; Si Hyung LEE ; Jun-Hyung CHO ; Yunho JUNG ; Kyoung Oh KIM ; Chan Gyoo KIM ; Kee Myung LEE ; Jong-Jae PARK ; Myung-Gyu CHOI ; Hoon Jai CHUN ; Ho Gak KIM
Clinical Endoscopy 2021;54(3):390-396
Background/Aims:
The aim of this in vivo animal study was to evaluate the effectiveness and safety of dedicated cold snare (DCS) compared with those of traditional snare (TS) for cold snare polypectomy (CSP).
Methods:
A total of 36 diminutive (5 mm) and 36 small (9 mm) pseudolesions were made by electrocoagulation in the colons of mini-pigs.
Results:
For the diminutive lesions, there were no significant differences in technical success rate, procedure time, or complete resection rate between the DCS and TS groups; the rate of uneven resection margin in the DCS group was significantly lower than that of the TS group. For small lesions, technical success rate and complete resection rate were significantly higher in the DCS group than in the TS group (100% [18/18] vs. 55.6% [10/18], p=0.003; 94.4% [17/18] vs. 40% [4/10], p=0.006). In addition, the procedure duration was significantly shorter, and the rate of uneven resection margin was significantly lower in the DCS group (28.5 sec vs. 66.0 sec, p=0.006; 11.1% [2/18] vs. 100% [10/10], p<0.001). Two cases of perforation occurred in the DCS group. Multivariate analysis revealed that DCS use was independently associated with complete resection.
Conclusions
DCS is superior to TS in terms of technical success, complete resection, and reducing the duration of the procedure for CSP of small polyps.

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