1.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
2.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
3.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
4.Guidelines for the Laboratory Diagnosis of Monkeypox in Korea
Ki Ho HONG ; Gab Jung KIM ; Kyoung Ho ROH ; Hyukmin LEE ; Ok Kyu PARK ; Taek Soo KIM ; Jae-Seok KIM ; Jaehyeon LEE ; Moon-Woo SEONG ; So Yeon KIM ; Jae-Sun PARK ; Younhee PARK ; Hee Jae HUH ; Namhee RYOO ; Hyun Soo KIM ; Heungsup SUNG ; Cheon Kwon YOO ;
Annals of Laboratory Medicine 2023;43(2):137-144
While the coronavirus disease 2019 pandemic is ongoing, monkeypox has been rapidly spreading in non-endemic countries since May 2022. Accurate and rapid laboratory tests are essential for identifying and controlling monkeypox. Korean Society for Laboratory Medicine and the Korea Disease Prevention and Control Agency have proposed guidelines for diagnosing monkeypox in clinical laboratories in Korea. These guidelines cover the type of tests, selection of specimens, collection of specimens, diagnostic methods, interpretation of test results, and biosafety. Molecular tests are recommended as confirmatory tests. Skin lesion specimens are recommended for testing in the symptomatic stage, and the collection of both blood and oropharyngeal swabs is recommended in the presymptomatic or prodromal stage.
5.Learning curve for single-port robot-assisted rectal cancer surgery
Moon Suk CHOI ; Seong Hyeon YUN ; Chang Kyu OH ; Jung Kyong SHIN ; Yoon Ah PARK ; Jung Wook HUH ; Yong Beom CHO ; Hee Cheol KIM ; Woo Yong LEE
Annals of Surgical Treatment and Research 2022;102(3):159-166
Purpose:
We analyzed the learning curve of single-port robotic (SPR)-assisted rectal cancer surgery.
Methods:
Fifty-seven consecutive SPR-assisted rectal cancer surgery cases performed by the same surgeon were considered in surgical interventions for rectal cancer. Total operation time (OT), docking time (DT), and surgeon console time (SCT) measured during surgery were used to parametrize the learning curve. The parameters representing the learning curve were evaluated using the cumulative sum (CUSUM).
Results:
The mean value of total OT was 241.8 ± 91.7 minutes, the mean value of DT was 20.6 ± 19.1 minutes, and the mean value of SCT was 135.9 ± 66.7 minutes. The learning curve was divided into phase 1 (initial 16 cases), phase 2 (second 16 cases), and phase 3 (subsequent 25 cases). The peak on the CUSUM graph occurred in the 21st case. The longest OT among phases was in phase 2. Complications were most frequent in phase 2. However, complications of Clavien-Dindo (CD) grade IIIb were most frequent in phase 3 with 2 patients. The most common complications were fluid collection and urinary retention (7 patients each). Complications of CD grade IIIb required one stomal revision due to stoma obstruction and one irrigation and loop ileostomy due to anastomosis leakage.
Conclusion
Improvement in surgical performance of SPR assisted rectal cancer operation was achieved after 21 cases.The three phases identified in the cumulative sum analysis showed a significant decrease in operative time after the middle stage of the learning curve without an increase in the complication rate.
6.Delayed Lesions on Diffusion-Weighted Imaging in Initially Lesion-Negative Stroke Patients
Kitae KIM ; Beom Joon KIM ; Jaewon HUH ; Seong Kyu YANG ; Mi Hwa YANG ; Moon-Ku HAN ; Cheolkyu JUNG ; Byung Se CHOI ; Jae Hyoung KIM ; Hee-Joon BAE
Journal of Stroke 2021;23(1):69-81
Background:
and Purpose Lesions on diffusion-weighted imaging (DWI) occasionally appear on follow-up magnetic resonance imaging (MRI) among initially DWI-negative but clinically suspicious stroke patients. We established the prevalence of positive conversion in DWI-negative stroke and determined the clinical factors associated with it.
Methods:
This retrospective, observational, single-center study included 5,271 patients hospitalized due to stroke/transient ischemic attack (TIA) in a single university hospital during 2010 to 2017. Patients without initial DWI lesions underwent follow-up DWI imaging as a routine practice. Adjusted hazard ratios (aHRs) for recurrent stroke risk according to positive conversion were determined using Cox proportional hazard regression. Adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for positive conversion among initially DWI-negative patients were estimated.
Results:
In total, 694 (13.2%) patients (mean±standard deviation age, 62.9±13.7 years; male, 404 [58.2%]) were initially DWI-negative. Among them, 22.5% had positive-conversion on follow-up DWI. Positive conversion was associated with a higher risk of recurrent stroke (aHR, 3.12; 95% CI, 1.56 to 6.26). Early neurologic deterioration (aOR, 15.1; 95% CI, 5.71 to 47.66), atrial fibrillation (aOR, 6.17; 95% CI, 3.23 to 12.01), smoking (aOR, 3.76; 95% CI, 2.19 to 6.63), pre-stroke dependency (aOR, 1.62; 95% CI, 1.15 to 2.27), objective hemiparesis (aOR, 4.39; 95% CI, 1.90 to 10.32), longer symptom duration (aOR, 2.17; 95% CI, 1.57 to 3.08), high cholesterol (aOR, 4.70; 95% CI, 1.78 to 12.77), National Institutes of Health Stroke Scale score (aOR, 1.44; 95% CI, 1.08 to 1.91), and high systolic blood pressure (aOR, 1.01; 95% CI, 1.00 to 1.02) were associated with a higher incidence of lesions with delayed appearance. Regarding the location of lesions on follow-up DWI, 34.6% and 21.2% were in the cortex and brainstem, respectively.
Conclusions
In DWI-negative stroke/TIA, positive conversion is associated with a higher risk of recurrent stroke. DWI-negative stroke with factors related to positive conversion may require follow-up MRI for a definitive diagnosis.
7.Long-term Oncologic Outcome of Postoperative Complications After Colorectal Cancer Surgery
Chang Kyu OH ; Jung Wook HUH ; You Jin LEE ; Moon Suk CHOI ; Dae Hee PYO ; Sung Chul LEE ; Seong Mun PARK ; Jung Kyong SHIN ; Yoon Ah PARK ; Yong Beom CHO ; Seong Hyeon YUN ; Hee Cheol KIM ; Woo Yong LEE
Annals of Coloproctology 2020;36(4):273-280
Purpose:
The impact of postoperative complications on long-term oncologic outcome after radical colorectal cancer surgery is controversial. The aim of this study was to examine the risk factors and oncologic outcomes of surgery-related postoperative complication groups.
Methods:
From January 2010 to December 2010, 310 patients experienced surgery-related postoperative complications after radical colorectal cancer surgery. These stage I–III patients were classified into 2 subgroups, minor (grades I, II) and major (grades III, IV) complication groups, according to extended Clavien-Dindo classification system criteria. Clinicopathologic differences between the 2 groups were analyzed to identify risk factors for major complications. The diseasefree survival rates of surgery-related postoperative complication groups were also compared.
Results:
Minor and major complication groups were stratified with 194 patients (62.6%) and 116 patients (37.4%), respectively. The risk factors influencing the major complication group were pathologic N category and operative method. The prognostic factors associated with disease-free survival were preoperative perforation, perineural invasion, tumor budding, and receiving neoadjuvant therapy. With a median follow-up period of 72.2 months, the 5-year disease-free survival rates were 84.4% in the minor group and 78.5% in the major group, but there was no statistical significance between the minor and major groups (P = 0.392).
Conclusion
Advanced cancer and open surgery were identified as risk factors for increased surgery-related major complications after radical colorectal cancer surgery. However, severity of postoperative complications did not affect disease-free survival from colorectal cancer.
8.Clinical comparison of low-volume agents (oral sulfate solution and sodium picosulfate with magnesium citrate) for bowel preparation: the EASE study
Jeeyeon KIM ; Hyun Gun KIM ; Kyeong Ok KIM ; Hyung Wook KIM ; Jongha PARK ; Jeong Sik BYEON ; Sung Wook HWANG ; Hyun Deok SHIN ; Jeong Eun SHIN ; Hyo Joon YANG ; Hyun Seok LEE ; Yunho JUNG ; Young Seok CHO ; Young Eun JOO ; Dae Seong MYUNG ; Kyu Chan HUH ; Eu Mi AHN
Intestinal Research 2019;17(3):413-418
BACKGROUND/AIMS: This study compared the efficacy, compliance, and safety of bowel preparation between sodium picosulfate with magnesium citrate (SPMC) and oral sulfate solution (OSS). METHODS: A prospective randomized multicenter study was performed. Split preparation methods were performed in both groups; the SPMC group, 2 sachets on the day before, and 1 sachet on the day of the procedure, the OSS group, half of the OSS with 1 L of water on both the day before and the day of the procedure. The adenoma detection rate (ADR), adequacy of bowel preparation using the Boston Bowel Preparation Scale (BBPS) score, patient satisfaction on a visual analog scale (VAS), and safety were compared between the 2 groups. RESULTS: This study analyzed 229 patients (121 in the SPMC group and 108 in the OSS group). ADR showed no differences between 2 groups (51.7% vs. 41.7%, P>0.05). The mean total BBPS score (7.95 vs. 8.11, P>0.05) and adequate bowel preparation rate (94.9% vs. 96.3%, P>0.05) were similar between the 2 groups. The mean VAS score for taste (7.62 vs. 6.87, P=0.006) was significantly higher in the SPMC group than in the OSS group. There were no significant differences in any other safety variables between the 2 groups except nausea symptom (36.1% vs. 20.3%, P=0.008). CONCLUSIONS: Bowel preparation for colonoscopy using low volume OSS and SPMC yielded similar ADRs and levels of efficacy. SPMC had higher levels of satisfaction for taste and feeling than did OSS.
Adenoma
;
Citric Acid
;
Colonoscopy
;
Compliance
;
Humans
;
Magnesium
;
Nausea
;
Patient Satisfaction
;
Prospective Studies
;
Sodium
;
Visual Analog Scale
;
Water
9.Efficacy of DA-9701 (Motilitone) in Functional Dyspepsia Compared to Pantoprazole: A Multicenter, Randomized, Double-blind, Non-inferiority Study.
Hye Kyung JUNG ; Kwang Jae LEE ; Myung Gyu CHOI ; Hyojin PARK ; Joon Seong LEE ; Poong Lyul RHEE ; Nayoung KIM ; Kyung Sik PARK ; Suck Chei CHOI ; Oh Young LEE ; Kyu Chan HUH ; Geun Am SONG ; Su Jin HONG ; Chong Il SOHN ; Hwoon Yong JUNG ; Yong Chan LEE ; Jong Sun REW ; Sam Ryong JEE ; Joong Goo KWON
Journal of Neurogastroenterology and Motility 2016;22(2):254-263
BACKGROUND/AIMS: The effect of proton pump inhibitors (PPI) in Asian functional dyspepsia (FD) patients has not been well established as in Western countries. DA-9701, a novel prokinetic agent, stimulates gastric emptying and modulates visceral hypersensitivity in vivo and in human studies. This study was conducted to compare the efficacy of DA-9701 with a conventional PPI in mono or combination therapy in patients with FD. METHODS: In this double-blind, randomized, non-inferiority trial, 389 patients diagnosed with FD using Rome III criteria were allocated among 3 groups: 30-mg DA-9701 t.i.d (means 3 times a day), 40-mg pantoprazole, and 30-mg DA-9701 t.i.d + 40-mg pantoprazole. The primary efficacy end-point was a global assessment of the patient binary response or response on a 5-Likert scale after 4 weeks. RESULTS: The global symptomatic improvement was 60.5% in the DA-9701 group, 65.6% in the pantoprazole group, and 63.5% in the DA-9701 + pantoprazole group using a 5-Likert scale at week 4 with no significant difference among 3 groups (P = 0.685). Symptom improvement measured by binary outcome was significantly achieved in each of the 3 groups, but not different among groups. Patients in all treatment groups reported significant improvement in the response rate and symptoms according to FD subtypes and dyspepsia-related quality of life (P < 0.001), but there were no significant differences among the 3 groups. CONCLUSIONS: DA-9701 improves global and individual symptoms and increases dyspepsia-specific quality of life in patients with FD. The efficacy of DA-9701 monotherapy is comparable with pantoprazole and there is no additive effect with combination of DA-9701 and pantoprazole in patients with FD.
Asian Continental Ancestry Group
;
Dyspepsia*
;
Gastric Emptying
;
Humans
;
Hypersensitivity
;
Proton Pump Inhibitors
;
Quality of Life
10.Gastric lesions in patients with Crohn's disease in Korea: a multicenter study.
Hoonsub SO ; Byong Duk YE ; Young Soo PARK ; Jihun KIM ; Joo Sung KIM ; Won MOON ; Kang Moon LEE ; You Sun KIM ; Bora KEUM ; Seong Eun KIM ; Kyeong Ok KIM ; Eun Soo KIM ; Chang Kyun LEE ; Sung Pil HONG ; Jong Pil IM ; Ja Seol KOO ; Chang Hwan CHOI ; Jeong Eun SHIN ; Bo In LEE ; Kyu Chan HUH ; Young Ho KIM ; Hyun Soo KIM ; Young Sook PARK ; Dong Soo HAN
Intestinal Research 2016;14(1):60-68
BACKGROUND/AIMS: Gastric pathology and Helicobacter pylori (H. pylori) infection among Asian patients with Crohn's disease (CD) are still unclear. We evaluated gastric histologic features and frequency of H. pylori infection in Korean patients with CD. METHODS: Among 492 patients with CD receiving upper gastrointestinal (GI) endoscopic evaluation in 19 Korean hospitals, we evaluated the endoscopic findings and gastric histopathologic features of 47 patients for our study. Histopathologic classification was performed using gastric biopsy tissues, and H. pylori infection was determined using the rapid urease test and histology. RESULTS: There were 36 men (76.6%), and the median age of patients at the time of upper GI endoscopy was 23.8 years (range, 14.2-60.5). For CD phenotype, ileocolonic disease was observed in 38 patients (80.9%), and non-stricturing, non-penetrating disease in 31 patients (66.0%). Twenty-eight patients (59.6%) complained of upper GI symptoms. Erosive gastritis was the most common gross gastric feature (66.0%). Histopathologically, H. pylori-negative chronic active gastritis (38.3%) was the most frequent finding. H. pylori testing was positive in 11 patients (23.4%), and gastric noncaseating granulomata were detected in 4 patients (8.5%). Gastric noncaseating granuloma showed a statistically significant association with perianal abscess/fistula (P=0.0496). CONCLUSIONS: H. pylori-negative chronic active gastritis appears to be frequent among Korean patients with CD. The frequency of H. pylori infection was comparable with previous studies. An association with perianal complications suggests a prognostic value for gastric noncaseating granuloma in patients with CD.
Asian Continental Ancestry Group
;
Biopsy
;
Classification
;
Crohn Disease*
;
Endoscopy
;
Gastritis
;
Granuloma
;
Helicobacter pylori
;
Humans
;
Korea*
;
Male
;
Pathology
;
Phenotype
;
Stomach
;
Urease

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