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 Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease
Su Hyun PARK ; Kang Nyeong LEE ; Oh Young LEE ; Myung Gyu CHOI ; Jie-Hyun KIM ; In-Kyung SUNG ; Jae Young JANG ; Kyung Sik PARK ; Hoon Jai CHUN ; Eun Young KIM ; Jun Kyu LEE ; Jin Seok JANG ; Gwang Ha KIM ; Su Jin HONG ; Yong Chan LEE ; Suck-Chei CHOI ; Hyun Soo KIM ; Tae Oh KIM ; Gwang Ho BAIK ; Yong Cheol JEON
Gut and Liver 2023;17(2):226-233
Background/Aims:
Efficacy of proton pump inhibitors is limited in patients with nonerosive reflux disease (NERD). The aim of this study was to comparatively evaluate the efficacy and safety of esomeprazole with sodium bicarbonate and esomeprazole alone.
Methods:
This was a multicenter, randomized, double-blind, active-controlled, noninferiority comparative study. A total of 379 patients with NERD were randomly allocated to receive either EsoduoⓇ/sup> (esomeprazole 20 mg with sodium bicarbonate 800 mg) or NexiumⓇ/sup> (esomeprazole 20 mg) once daily for 4 weeks from January 2019 to December 2019. The patients had a history of heartburn for at least 2 days in the week before randomization as well as in the last 3 months and no esophageal mucosal breaks on endoscopy. The primary endpoint was a complete cure of heartburn at week 4. The secondary and exploratory endpoints as well as the safety profiles were compared in the groups at weeks 2 and 4.
Results:
A total of 355 patients completed the study (180 in the EsoduoⓇ/sup> group and 175 in the NexiumⓇ/sup> group). The proportions of patients without heartburn in the entire 4th week of treatment were not different between the two groups (33.33% in the EsoduoⓇ/sup> group and 35% in the NexiumⓇ/sup> group, p=0.737). There were no significant differences in most of the secondary and exploratory endpoints as well as the safety profiles.
Conclusions
EsoduoⓇ/sup> is as effective and safe as NexiumⓇ/sup> for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).
3.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
4.Long-term Outcomes of Undifferentiated-Type Early Gastric Cancer with Positive Horizontal Margins after Endoscopic Resection
Hyo-Joon YANG ; Wan-Sik LEE ; Bong Eun LEE ; Ji Yong AHN ; Jae-Young JANG ; Joo Hyun LIM ; Su Youn NAM ; Jie-Hyun KIM ; Byung-Hoon MIN ; Moon Kyung JOO ; Jae Myung PARK ; Woon Geon SHIN ; Hang Lak LEE ; Tae-Geun GWEON ; Moo In PARK ; Jeongmin CHOI ; Chung Hyun TAE ; Young-Il KIM ; Il Ju CHOI
Gut and Liver 2021;15(5):723-731
Background/Aims:
This study examined the long-term outcomes of undifferentiated-type early gastric cancer (UD EGC) with positive horizontal margins (HMs) after endoscopic resection (ER) and compared them between additional surgery and nonsurgical management.
Methods:
From 2005 to 2015, a total of 1,124 patients with UD EGC underwent ER at 18 tertiary hospitals in Korea. Of them, 92 patients with positive HMs as the only noncurative factor (n=25) or with both positive HMs and tumor size >2 cm (n=67) were included. These patients underwent additional surgery (n=40), underwent additional endoscopic treatment (n=6), or were followed up without further treatment (n=46).
Results:
No lymph node (LN) metastasis was found in patients who underwent additional surgery. During a median follow-up of 57.7 months (interquartile range, 27.6 to 68.8 months), no LN or distant metastases or gastric cancer-related deaths occurred in the overall cohort. At baseline, the residual cancer rate was 57.8% (26/45) after additional surgery or ER. The 5-year local recurrence rate was 33.6% among patients who were followed up without additional treatment. The 5-year overall survival rates were 95.0% and 87.8% after additional surgery and nonsurgical management (endoscopic treatment or close follow-up), respectively (log-rank p=0.224). In the multivariate Cox regression analysis, nonsurgical management was not associated with an increased risk of mortality.
Conclusions
UD EGC with positive HMs after ER may have favorable long-term outcomes and a very low risk of LN metastasis. Nonsurgical management may be suggested as an alternative, particularly for patients with old age or chronic illness.
5.Long-term Outcomes of Undifferentiated-Type Early Gastric Cancer with Positive Horizontal Margins after Endoscopic Resection
Hyo-Joon YANG ; Wan-Sik LEE ; Bong Eun LEE ; Ji Yong AHN ; Jae-Young JANG ; Joo Hyun LIM ; Su Youn NAM ; Jie-Hyun KIM ; Byung-Hoon MIN ; Moon Kyung JOO ; Jae Myung PARK ; Woon Geon SHIN ; Hang Lak LEE ; Tae-Geun GWEON ; Moo In PARK ; Jeongmin CHOI ; Chung Hyun TAE ; Young-Il KIM ; Il Ju CHOI
Gut and Liver 2021;15(5):723-731
Background/Aims:
This study examined the long-term outcomes of undifferentiated-type early gastric cancer (UD EGC) with positive horizontal margins (HMs) after endoscopic resection (ER) and compared them between additional surgery and nonsurgical management.
Methods:
From 2005 to 2015, a total of 1,124 patients with UD EGC underwent ER at 18 tertiary hospitals in Korea. Of them, 92 patients with positive HMs as the only noncurative factor (n=25) or with both positive HMs and tumor size >2 cm (n=67) were included. These patients underwent additional surgery (n=40), underwent additional endoscopic treatment (n=6), or were followed up without further treatment (n=46).
Results:
No lymph node (LN) metastasis was found in patients who underwent additional surgery. During a median follow-up of 57.7 months (interquartile range, 27.6 to 68.8 months), no LN or distant metastases or gastric cancer-related deaths occurred in the overall cohort. At baseline, the residual cancer rate was 57.8% (26/45) after additional surgery or ER. The 5-year local recurrence rate was 33.6% among patients who were followed up without additional treatment. The 5-year overall survival rates were 95.0% and 87.8% after additional surgery and nonsurgical management (endoscopic treatment or close follow-up), respectively (log-rank p=0.224). In the multivariate Cox regression analysis, nonsurgical management was not associated with an increased risk of mortality.
Conclusions
UD EGC with positive HMs after ER may have favorable long-term outcomes and a very low risk of LN metastasis. Nonsurgical management may be suggested as an alternative, particularly for patients with old age or chronic illness.
6.Multidisciplinary and Multisociety Practice Guideline on Reprocessing Flexible Gastrointestinal Endoscopes and Endoscopic Accessories
Dae Young CHEUNG ; Byung Ik JANG ; Sang Wook KIM ; Jie-Hyun KIM ; Hyung Keun KIM ; Jeong Eun SHIN ; Won Jae YOON ; Yong Kang LEE ; Kwang Hyun CHUNG ; Soo-Jeong CHO ; Hyun Phil SHIN ; Sun Young CHO ; Woon Geon SHIN ; Kee Don CHOI ; Byung-Wook KIM ; Joong Goo KWON ; Hee Chan YANG ; Tae-Geun GWEON ; Hyun Gun KIM ; Dong-Won AHN ; Kwang Bum CHO ; Sun Hee KIM ; Kyong Hwa HWANG ; Hee Hyuk IM
Clinical Endoscopy 2020;53(3):276-285
The area of endoscopic application has been continuously expanded since its introduction in the last century and the frequency of its use also increased stiffly in the last decades. Because gastrointestinal endoscopy is naturally exposed to diseased internal organs and contact with pathogenic materials, endoscopy mediated infection or disease transmission becomes a major concern in this field. Gastrointestinal endoscopy is not for single use and the proper reprocessing process is a critical factor for safe and reliable endoscopy procedures. What needed in these circumstances is a practical guideline for reprocessing the endoscope and its accessories which is feasible in the real clinical field to guarantee acceptable prevention of pathogen transmission. This guideline contains principles and instructions of the reprocessing procedure according to the step by step. And it newly includes general information and updated knowledge about endoscopy-mediated infection and disinfection. Multiple societies and working groups participated to revise; Korean Association for the Study of the Liver, the Korean Society of Infectious Diseases, Korean College of Helicobacter and Upper Gastrointestinal Research, the Korean Society of Gastroenterology, Korean Society of Gastrointestinal Cancer, Korean Association for the Study of Intestinal Diseases, Korean Pancreatobiliary Association, the Korean Society of Gastrointestinal Endoscopy Nurses and Associates and Korean Society of Gastrointestinal Endoscopy. Through this cooperation, we enhanced communication and established a better concordance. We still need more researches in this field and fill up the unproven area. And our guidelines will be renewed accordingly.
7.Validity and Reliability of the Korean Version of the Hyperthyroidism Symptom Scale.
Jie Eun LEE ; Dong Hwa LEE ; Tae Jung OH ; Kyoung Min KIM ; Sung Hee CHOI ; Soo LIM ; Young Joo PARK ; Do Joon PARK ; Hak Chul JANG ; Jae Hoon MOON
Endocrinology and Metabolism 2018;33(1):70-78
BACKGROUND: Thyrotoxicosis is a common disease resulting from an excess of thyroid hormones, which affects many organ systems. The clinical symptoms and signs are relatively nonspecific and can vary depending on age, sex, comorbidities, and the duration and cause of the disease. Several symptom rating scales have been developed in an attempt to assess these symptoms objectively and have been applied to diagnosis or to evaluation of the response to treatment. The aim of this study was to assess the reliability and validity of the Korean version of the hyperthyroidism symptom scale (K-HSS). METHODS: Twenty-eight thyrotoxic patients and 10 healthy subjects completed the K-HSS at baseline and after follow-up at Seoul National University Bundang Hospital. The correlation between K-HSS scores and thyroid function was analyzed. K-HSS scores were compared between baseline and follow-up in patient and control groups. Cronbach's α coefficient was calculated to demonstrate the internal consistency of K-HSS. RESULTS: The mean age of the participants was 34.7±9.8 years and 13 (34.2%) were men. K-HSS scores demonstrated a significant positive correlation with serum free thyroxine concentration and decreased significantly with improved thyroid function. K-HSS scores were highest in subclinically thyrotoxic subjects, lower in patients who were euthyroid after treatment, and lowest in the control group at follow-up, but these differences were not significant. Cronbach's α coefficient for the K-HSS was 0.86. CONCLUSION: The K-HSS is a reliable and valid instrument for evaluating symptoms of thyrotoxicosis in Korean patients.
Comorbidity
;
Diagnosis
;
Follow-Up Studies
;
Healthy Volunteers
;
Humans
;
Hyperthyroidism*
;
Male
;
Reproducibility of Results*
;
Seoul
;
Thyroid Gland
;
Thyroid Hormones
;
Thyrotoxicosis
;
Thyroxine
;
Weights and Measures
8.The Clinical Profile of Patients with Psoriasis in Korea: A Nationwide Cross-Sectional Study (EPI-PSODE).
Hae Jun SONG ; Chul Jong PARK ; Tae Yoon KIM ; Yong Beom CHOE ; Seok Jong LEE ; Nack In KIM ; Jae We CHO ; Jie Hyun JEON ; Min Soo JANG ; Jai Il YOUN ; Myung Hwa KIM ; Joonsoo PARK ; Ki Ho KIM ; Byung Soo KIM ; Sang Woong YOUN ; Joo Heung LEE ; Min Geol LEE ; Sung Ku AHN ; Young Ho WON ; Seok Kweon YUN ; Bong Seok SHIN ; Seong Jun SEO ; Ji Yeoun LEE ; Kwang Joong KIM ; Young Suck RO ; Youngdoe KIM ; Dae Young YU ; Jee Ho CHOI
Annals of Dermatology 2017;29(4):462-470
BACKGROUND: Psoriasis is an immune-mediated, chronic inflammatory disease affecting multiple aspects of patients' lives. Its epidemiology varies regionally; however, nationwide epidemiologic data on psoriasis depicting profile of Korean patients has not been available to date. OBJECTIVE: To understand nationwide epidemiologic characteristics and clinical features of adult patients with psoriasis visited university hospitals in Korea. METHODS: This multicenter, non-interventional, cross-sectional study recruited 1,278 adult patients with psoriasis across 25 centers in Korea in 2013. Various clinical data including PASI, BSA, DLQI, SF-36 and PASE were collected. RESULTS: A total of 1,260 patients completed the study (male:female=1.47:1). The mean age was 47.0 years with a distribution mostly in the 50s (24.9%). Early onset (<40 years) of psoriasis accounted for 53.9% of patients. The mean disease duration was 109.2 months; mean body mass index was 23.9 kg/m²; and 12.7% of patients had a family history of psoriasis. Plaque and guttate types of psoriasis accounted for 85.8% and 8.4%, respectively. Patients with PASI ≥10 accounted for 24.9%; patients with body surface area ≥10 were 45.9%. Patients with DLQI ≥6 accounted for 78.8%. Between PASI <10 and PASI ≥10 groups, significant difference was noted in age at diagnosis, disease duration, blood pressure, waist circumference of female, and treatment experiences with phototherapy, systemic agents, and biologics. CONCLUSION: This was the first nationwide epidemiologic study of patients with psoriasis in Korea and provides an overview of the epidemiologic characteristics and clinical profiles of this patient population.
Adult
;
Biological Products
;
Blood Pressure
;
Body Mass Index
;
Body Surface Area
;
Cross-Sectional Studies*
;
Diagnosis
;
Epidemiologic Studies
;
Epidemiology
;
Female
;
Hospitals, University
;
Humans
;
Korea*
;
Phototherapy
;
Psoriasis*
;
Waist Circumference
9.Effect of cell-penetrating peptide-conjugated estrogen-related receptor beta on the development of mouse embryos cultured in vitro.
Ning Jie YANG ; Dong Won SEOL ; Junghyun JO ; Hyun Mee JANG ; Sook Young YOON ; Dong Ryul LEE
Clinical and Experimental Reproductive Medicine 2014;41(1):1-8
OBJECTIVE: Estrogen related receptor beta (Esrrb) is a member of the orphan nuclear receptors and may regulate the expression of pluripotency-related genes, such as Oct4 and Nanog. Therefore, in the present study, we have developed a method for delivering exogenous ESRRB recombinant protein into embryos by using cell-penetrating peptide (CPP) conjugation and have analyzed their effect on embryonic development. METHODS: Mouse oocytes and embryos were obtained from superovulated mice. The expression of Oct4 mRNA and the cell number of inner cell mass (ICM) in the in vitro-derived and in vivo-derived blastocysts were first analyzed by real time-reverse transcription-polymerase chain reaction and differential staining. Then 8-cell embryos were cultured in KSOM media with or without 2 microg/mL CPP-ESRRB protein for 24 to 48 hours, followed by checking their integration into embryos during in vitro culture by Western blot and immunocytochemistry. RESULTS: Expression of Oct4 and the cell number of ICM were lower in the in vitro-derived blastocysts than in the in vivo-derived ones (p<0.05). In the blastocysts derived from the CPP-ESRRB-treated group, expression of Oct4 was greater than in the non-treated groups (p<0.05). Although no difference in embryonic development was observed between the treated and non-treated groups, the cell number of ICM was greater in the CPP-ESRRB-treated group. CONCLUSION: Treatment of CPP-ESRRB during cultivation could increase embryos' expression of Oct4 and the formation rate of the ICM in the blastocyst. Additionally, an exogenous delivery system of CPP-conjugated protein would be a useful tool for improving embryo culture systems.
Animals
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Blastocyst
;
Blotting, Western
;
Cell Count
;
Embryonic Development
;
Embryonic Structures*
;
Estrogens
;
Female
;
Immunohistochemistry
;
Mice*
;
Oocytes
;
Orphan Nuclear Receptors
;
Pregnancy
;
RNA, Messenger
10.The Relationship Between Gastric Myoelectric Activity and SCN5A Mutation Suggesting Sodium Channelopathy in Patients With Brugada Syndrome and Functional Dyspepsia: A Pilot Study.
Kyo Tae JUNG ; Hyojin PARK ; Jie Hyun KIM ; Dong Jik SHIN ; Bo Young JOUNG ; Moon Hyoung LEE ; Yang Soo JANG
Journal of Neurogastroenterology and Motility 2012;18(1):58-63
BACKGROUND/AIMS: SCN5A encodes the cardiac-specific NaV1.5 sodium channel, and Brugada syndrome is a cardiac conduction disorder associated with sodium channel alpha-subunit (SCN5A) mutation. The SCN5A-encoded NaV1.5 channel is also found on gastrointestinal smooth muscle and interstitial cells of Cajal. We investigated the relationship between functional dyspepsia (FD) and SCN5A mutation to evaluate sodium channelopathy in FD. METHODS: Patients with Brugada syndrome or FD were examined using upper endoscopy, electrogastrography (EGG), FD symptom questionnaire based on Rome III criteria and genetic testing for SCN5A mutation. Symptom scores of FD and EGG findings were analyzed according to SCN5A mutation. RESULTS: A total of 17 patients (4 Brugada syndrome and 13 FD) participated in the study. An SCN5A mutation was noted in 75.0% of the patients with Brugada syndrome and in 1 (7.7%) of the patients with FD. Of 4 patients with SCN5A mutation, 2 (50%) had FD. Postprandial tachygastria and bradygastria were noted in 2 (50%) and 1 (25%) of the patients with SCN5A mutation, respectively. The EGG findings were not significantly different between positive and negative mutation in 17 patients. CONCLUSIONS: Although we did not find statistically significant results, we suggest that it is meaningful to attempt to identify differences in symptoms and gastric myoelectric activity according to the presence of an SCN5A mutation by EGG analysis. The relationship between FD and sodium channelopathy should be elucidated in the future by a large-scale study.
Brugada Syndrome
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Channelopathies
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Dyspepsia
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Endoscopy
;
Gastrointestinal Diseases
;
Genetic Testing
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Humans
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Interstitial Cells of Cajal
;
Muscle, Smooth
;
Ovum
;
Pilot Projects
;
Surveys and Questionnaires
;
Rome
;
Sodium
;
Sodium Channels

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