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.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.
3.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.
4.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.
5.Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, DoubleBlind, Active Control, Noninferiority, Multicenter, Phase 3 Study
Gwang Ha KIM ; Hang Lak LEE ; Moon Kyung JOO ; Hong Jun PARK ; Sung Woo JUNG ; Ok-Jae LEE ; Hyungkil KIM ; Hoon Jai CHUN ; Soo Teik LEE ; Ji Won KIM ; Han Ho JEON ; Il-Kwun CHUNG ; Hyun-Soo KIM ; Dong Ho LEE ; Kyoung-Oh KIM ; Yun Jeong LIM ; Seun-Ja PARK ; Soo-Jeong CHO ; Byung-Wook KIM ; Kwang Hyun KO ; Seong Woo JEON ; Jae Gyu KIM ; In-Kyung SUNG ; Tae Nyeun KIM ; Jae Kyu SUNG ; Jong-Jae PARK
Gut and Liver 2021;15(6):841-850
Background/Aims:
The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta Ⓡ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis.
Methods:
This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucosta Ⓡ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta Ⓡ , n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta Ⓡ , n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated.
Results:
According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was −4.01% (95% confidence interval [CI], –13.09% to 5.06%) in the ITT analysis and −4.44% (95% CI, –13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucosta Ⓡ -treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates.
Conclusions
The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucosta Ⓡ ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.
6.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.
7.An Optimization of AAV-82Q-Delivered Rat Model of Huntington’s Disease
Kyoung-Ha SO ; Jai Ho CHOI ; Jaisan ISLAM ; Elina KC ; Hyeong Cheol MOON ; So Yoon WON ; Hyong Kyu KIM ; Soochong KIM ; Sang-Hwan HYUN ; Young Seok PARK
Journal of Korean Neurosurgical Society 2020;63(5):579-589
Objective:
: No optimum genetic rat Huntington model both neuropathological using an adeno-associated virus (AAV-2) vector vector has been reported to date. We investigated whether direct infection of an AAV2 encoding a fragment of mutant huntingtin (AV2-82Q) into the rat striatum was useful for optimizing the Huntington rat model.
Methods:
: We prepared ten unilateral models by injecting AAV2-82Q into the right striatum, as well as ten bilateral models. In each group, five rats were assigned to either the 2×1012 genome copies (GC)/mL of AAV2-82Q (×1, low dose) or 2×1013 GC/mL of AAV2-82Q (×10, high dose) injection model. Ten unilateral and ten bilateral models injected with AAV-empty were also prepared as control groups. We performed cylinder and stepping tests 2, 4, 6, and 8 weeks after injection, tested EM48 positive mutant huntingtin aggregates.
Results:
: The high dose of unilateral and bilateral AAV2-82Q model showed a greater decrease in performance on the stepping and cylinder tests. We also observed more prominent EM48-positive mutant huntingtin aggregates in the medium spiny neurons of the high dose of AAV2-82Q injected group.
Conclusion
: Based on the results from the present study, high dose of AAV2-82Q is the optimum titer for establishing a Huntington rat model. Delivery of high dose of human AAV2-82Q resulted in the manifestation of Huntington behaviors and optimum expression of the huntingtin protein in vivo.
8.Anhedonia and Dysphoria Are Differentially Associated with the Risk of Dementia in the Cognitively Normal Elderly Individuals: A Prospective Cohort Study
Ju Ri LEE ; Seung Wan SUH ; Ji Won HAN ; Seonjeong BYUN ; Soon Jai KWON ; Kyoung Hwan LEE ; Kyung Phil KWAK ; Bong Jo KIM ; Shin Gyeom KIM ; Jeong Lan KIM ; Tae Hui KIM ; Seung Ho RYU ; Seok Woo MOON ; Joon Hyuk PARK ; Dong Woo LEE ; Jong Chul YOUN ; Dong Young LEE ; Seok Bum LEE ; Jung Jae LEE ; Jin Hyeong JHOO ; Ki Woong KIM
Psychiatry Investigation 2019;16(8):575-580
OBJECTIVE: We investigated the impact of depressed mood (dysphoria) and loss of interest or pleasure (anhedonia)on the risk of dementia in cognitively-normal elderly individuals. METHODS: This study included 2,685 cognitively-normal elderly individuals who completed the baseline and 4-year follow-up assessments of the Korean Longitudinal Study on Cognitive Aging and Dementia. We ascertained the presence of dysphoria and anhedonia using the Mini International Neuropsychiatric Inventory. We defined subjective cognitive decline as the presence of subjective cognitive complaints without objective cognitive impairments. We analyzed the association of dysphoria and anhedonia with the risk of cognitive disorders using multinomial logistic regression analysis adjusted for age, sex, education, Cumulative Illness Rating Scale score, Apolipoprotein E genotype, and neuropsychological test performance. RESULTS: During the 4-year follow-up period, anhedonia was associated with an approximately twofold higher risk of mild cognitive impairment (OR=2.09, 95% CI=1.20–3.64, p=0.008) and fivefold higher risk of dementia (OR=5.07, 95% CI=1.44–17.92, p=0.012) but was not associated with the risk of subjective cognitive decline. In contrast, dysphoria was associated with an approximately twofold higher risk of subjective cognitive decline (OR=2.06, 95% CI=1.33–3.19, p=0.001) and 1.7-fold higher risk of mild cognitive impairment (OR=1.75, 95% CI=1.00–3.05, p=0.048) but was not associated with the risk of dementia. CONCLUSION: Anhedonia, but not dysphoria, is a risk factor of dementia in cognitively-normal elderly individuals.
Aged
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Anhedonia
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Apolipoproteins
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Cognition Disorders
;
Cognitive Aging
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Cohort Studies
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Dementia
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Depression
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Education
;
Follow-Up Studies
;
Genotype
;
Humans
;
Logistic Models
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Longitudinal Studies
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Mild Cognitive Impairment
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Neuropsychological Tests
;
Pleasure
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Prospective Studies
;
Risk Factors
9.Clinical Factors Associated with Obstructive Coronary Artery Disease in Patients with Out-of-Hospital Cardiac Arrest: Data from the Korean Cardiac Arrest Research Consortium (KoCARC) Registry
Jiesuck PARK ; Jonghwan SHIN ; Hack Lyoung KIM ; Kyoung Jun SONG ; Jin Hee JUNG ; Hui Jai LEE ; Kyoung Min YOU ; Woo Hyun LIM ; Jae Bin SEO ; Sang Hyun KIM ; Joo Hee ZO ; Myung A KIM ;
Journal of Korean Medical Science 2019;34(22):e159-
BACKGROUND: Although coronary artery disease (CAD) is a major cause of out-of-hospital cardiac arrest (OHCA), there has been no convinced data on the necessity of routine invasive coronary angiography (ICA) in OHCA. We investigated clinical factors associated with obstructive CAD in OHCA. METHODS: Data from 516 OHCA patients (mean age 58 years, 83% men) who underwent ICA after resuscitation was obtained from a nation-wide OHCA registry. Obstructive CAD was defined as the lesions with diameter stenosis ≥ 50% on ICA. Independent clinical predictors for obstructive CAD were evaluated using multiple logistic regression analysis, and their prediction performance was compared using area under the receiver operating characteristic curve with 10,000 repeated random permutations. RESULTS: Among study patients, 254 (49%) had obstructive CAD. Those with obstructive CAD were older (61 vs. 55 years, P < 0.001) and had higher prevalence of hypertension (54% vs. 36%, P < 0.001), diabetes mellitus (29% vs. 21%, P = 0.032), positive cardiac enzyme (84% vs. 74%, P = 0.010) and initial shockable rhythm (70% vs. 61%, P = 0.033). In multiple logistic regression analysis, old age (≥ 60 years) (odds ratio [OR], 2.01; 95% confidence interval [CI], 1.36–3.00; P = 0.001), hypertension (OR, 1.74; 95% CI, 1.18–2.57; P = 0.005), positive cardiac enzyme (OR, 1.72; 95% CI, 1.09–2.70; P = 0.019), and initial shockable rhythm (OR, 1.71; 95% CI, 1.16–2.54; P = 0.007) were associated with obstructive CAD. Prediction ability for obstructive CAD increased proportionally when these 4 factors were sequentially combined (P < 0.001). CONCLUSION: In patients with OHCA, those with old age, hypertension, positive cardiac enzyme and initial shockable rhythm were associated with obstructive CAD. Early ICA should be considered in these patients.
Constriction, Pathologic
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Coronary Angiography
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Coronary Artery Disease
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Coronary Vessels
;
Diabetes Mellitus
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Heart Arrest
;
Humans
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Hypertension
;
Logistic Models
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Out-of-Hospital Cardiac Arrest
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Prevalence
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Resuscitation
;
Risk Factors
;
ROC Curve
10.A Randomized Controlled Trial of Compression Rates during Cardiopulmonary Resuscitation.
Sung Oh HWANG ; Kyoung Chul CHA ; Kyuseok KIM ; You Hwan JO ; Sung Phil CHUNG ; Je Sung YOU ; Jonghwan SHIN ; Hui Jai LEE ; Yoo Seok PARK ; Seunghwan KIM ; Sang Cheon CHOI ; Eun Jung PARK ; Won Young KIM ; Dong Woo SEO ; Sungwoo MOON ; Gapsu HAN ; Han Sung CHOI ; Hyunggoo KANG ; Seung Min PARK ; Woon Yong KWON ; Eunhee CHOI
Journal of Korean Medical Science 2016;31(9):1491-1498
The objective of this study was to compare the efficacy of cardiopulmonary resuscitation (CPR) with 120 compressions per minute (CPM) to CPR with 100 CPM in patients with non-traumatic out-of-hospital cardiac arrest. We randomly assigned patients with non-traumatic out-of-hospital cardiac arrest into two groups upon arrival to the emergency department (ED). The patients received manual CPR either with 100 CPM (CPR-100 group) or 120 CPM (CPR-120 group). The primary outcome measure was sustained restoration of spontaneous circulation (ROSC). The secondary outcome measures were survival discharge from the hospital, one-month survival, and one-month survival with good functional status. Of 470 patients with cardiac arrest, 136 patients in the CPR-100 group and 156 patients in the CPR-120 group were included in the final analysis. A total of 69 patients (50.7%) in the CPR-100 group and 67 patients (42.9%) in the CPR-120 group had ROSC (absolute difference, 7.8% points; 95% confidence interval [CI], -3.7 to 19.2%; P = 0.183). The rates of survival discharge from the hospital, one-month survival, and one-month survival with good functional status were not different between the two groups (16.9% vs. 12.8%, P = 0.325; 12.5% vs. 6.4%, P = 0.073; 5.9% vs. 2.6%, P = 0.154, respectively). We did not find differences in the resuscitation outcomes between those who received CPR with 100 CPM and those with 120 CPM. However, a large trial is warranted, with adequate power to confirm a statistically non-significant trend toward superiority of CPR with 100 CPM. (Clinical Trial Registration Information: www.cris.nih.go.kr, cris.nih.go.kr number, KCT0000231)
Cardiopulmonary Resuscitation*
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Emergency Service, Hospital
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Heart Arrest
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Humans
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Out-of-Hospital Cardiac Arrest
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Outcome Assessment (Health Care)
;
Resuscitation

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