1.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.
2.Long-Term Clinical Outcomes of Endoscopic Submucosal Dissection in Patients with Early Gastric Cancer: A Prospective Multicenter Cohort Study.
Sang Gyun KIM ; Chan Mi PARK ; Na Rae LEE ; Jiyoung KIM ; Da Hyun LYU ; Seung Hee PARK ; Il Ju CHOI ; Wan Sik LEE ; Seun Ja PARK ; Jae Jun KIM ; Ji Hyun KIM ; Chul Hyun LIM ; Joo Young CHO ; Gwang Ha KIM ; Yong Chan LEE ; Hwoon Yong JUNG ; Jun Haeng LEE ; Hoon Jai CHUN ; Sang Yong SEOL
Gut and Liver 2018;12(4):402-410
BACKGROUND/AIMS: Endoscopic submucosal dissection (ESD) has been regarded as a curative treatment for early gastric cancer (EGC) in indicated cases. The aim of this study was to evaluate the nationwide long-term clinical outcomes of ESD for EGC in Korea. METHODS: A prospective multicenter cohort study was performed to evaluate the long-term efficacy of ESD for EGC within pre-defined indications at 12 institutes in Korea. The cases that met the expanded criteria upon pathological review after ESD were followed for 5 years. The primary outcome was 5-year disease specific free survival. RESULTS: Six hundred ninety-seven patients with 722 EGCs treated with ESD were prospectively enrolled and followed for 5 years. Complete resection was achieved in 81.3% of the cases, and curative resection was achieved in 86.1%. During the 5-year follow-up, the overall survival rate was 96.6%, and the disease specific free survival rate was 90.6%. Local recurrence developed in 0.9%, and metachronous tumor development occurred in 7.8%; both conditions were treated by endoscopic or surgical treatment. Distant metastasis developed in 0.5% during follow-up. CONCLUSIONS: ESD showed excellent long-term clinical outcomes and can be accepted as a curative treatment for patients with EGC who meet the expanded criteria in final pathology studies.
Academies and Institutes
;
Cohort Studies*
;
Follow-Up Studies
;
Humans
;
Korea
;
Neoplasm Metastasis
;
Pathology
;
Prospective Studies*
;
Recurrence
;
Stomach Neoplasms*
;
Survival Rate
3.Effectiveness and Safety of Biolimus A9™-Eluting stEnt in Patients with AcUTe Coronary sYndrome; A Multicenter, Observational Study (BEAUTY Study)
Keun Ho PARK ; Myung Ho JEONG ; Young Joon HONG ; Youngkeun AHN ; Hyun Kuk KIM ; Young Yub KOH ; Doo Il KIM ; Sang Wook KIM ; Weon KIM ; Seung Woon RHA ; Jay Young RHEW ; Jong Seon PARK ; Hun Sik PARK ; Jang Ho BAE ; Jang Whan BAE ; Seok Kyu OH ; Sung Yun LEE ; Seung Wook LEE ; Jae Hwan LEE ; Sang Yeob LIM ; Jang Hyun CHO ; Kwang Soo CHA ; Jai Keon CHAE ; Seung Ho HUR ; Sun Ho HWANG ; Jin Yong HWANG
Yonsei Medical Journal 2018;59(1):72-79
PURPOSE: This study sought to determine the 1-year clinical effectiveness and safety of a biodegradable, polymer-containing Biolimus A9™-eluting stent (BES) in Korean patients with acute coronary syndrome (ACS). MATERIALS AND METHODS: A total of 1000 ACS patients with 1251 lesions who underwent implantation of BESs at 22 centers in Korea were enrolled between May 2011 and July 2013. We assessed major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinical-driven target vessel revascularization at 12 months. RESULTS: Patient mean age was 62.6±11.4 years. 72.8% of the patients were male, 28.5% had diabetes, 32.8% had multi-vessel disease (MVD), and 47.9% presented with acute MI (AMI). The mean global registry of acute coronary events risk score of all patients was 103.0±27.6. The number of stents per patient was 1.3±0.6. The incidences of MACE and definite stent thrombosis at 12 months were 3.9% and 0.2%, respectively. On multivariate Cox-regression analysis, age ≥65 years was identified as an independent predictors of 1-year MACE (hazard ratio=2.474; 95% confidence interval=1.202−5.091). Subgroup analyses revealed no significant differences in the incidence of MACE between patients with and without diabetes (4.3% vs. 3.7%, p=0.667), between those who presented with and without AMI (4.4% vs. 3.4%, p=0.403), and between those with and without MVD (4.6% vs. 3.5%, p=0.387). CONCLUSION: Our study demonstrated excellent 1-year clinical outcomes of BES implantation in patients at low-risk for ACS.
Acute Coronary Syndrome/drug therapy
;
Aged
;
Drug-Eluting Stents/adverse effects
;
Female
;
Humans
;
Incidence
;
Kaplan-Meier Estimate
;
Male
;
Middle Aged
;
Multivariate Analysis
;
Proportional Hazards Models
;
Republic of Korea
;
Sirolimus/adverse effects
;
Sirolimus/analogs & derivatives
;
Sirolimus/therapeutic use
;
Time Factors
;
Treatment Outcome
4.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
5.Quality of Life after Endoscopic Submucosal Dissection for Early Gastric Cancer: A Prospective Multicenter Cohort Study.
Sang Gyun KIM ; Seon Mi JI ; Na Rae LEE ; Seung Hee PARK ; Ji Hye YOU ; Il Ju CHOI ; Wan Sik LEE ; Seun Ja PARK ; Jun Haeng LEE ; Sang Yong SEOL ; Ji Hyun KIM ; Chul Hyun LIM ; Joo Young CHO ; Gwang Ha KIM ; Hoon Jai CHUN ; Yong Chan LEE ; Hwoon Yong JUNG ; Jae J KIM
Gut and Liver 2017;11(1):87-92
BACKGROUND/AIMS: Endoscopic submucosal dissection (ESD) has been an established treatment for indicated early gastric cancer (EGC) without deterioration of quality of life (QOL) compared with surgical resection. The aim of this study was to evaluate long-term QOL in patients undergoing ESD for EGC. METHODS: Patients scheduled to undergo curative ESD for EGC were prospectively enrolled from 12 institutions between May 2010 and December 2011. Assessments of QOL with Korean versions of the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaire-core (QLQ-C30) and a gastric cancer-specific questionnaire (STO22) were performed at baseline and at 7 days, 3 months, and 6 months after ESD. RESULTS: A total of 666 subjects were assessed for QLQ-C30 and QLQ-STO22. The mean QLQ-C30 score was 69.5 at baseline, 68.8 at 7 days, 73.1 at 3 months, and 73.2 at 6 months. The global health status on the EORTC QLQ-C30 was significantly improved after 3 and 6 months (p=0.0003 and p<0.0001, respectively). The QLQ-C30 and STO22 scores were not significantly different, or they only slightly deteriorated between before and immediately after ESD, but they were significantly improved after 3 and 6 months (p<0.05). CONCLUSIONS: QOL did not deteriorate immediately after ESD, and it improved more significantly at up to 6 months in patients who underwent curative ESD for EGC without significant complications.
Cohort Studies*
;
Global Health
;
Humans
;
Prospective Studies*
;
Quality of Life*
;
Stomach Neoplasms*
6.Short-Term Outcomes of Endoscopic Submucosal Dissection in Patients with Early Gastric Cancer: A Prospective Multicenter Cohort Study.
Il Ju CHOI ; Na Rae LEE ; Sang Gyun KIM ; Wan Sik LEE ; Seun Ja PARK ; Jae J KIM ; Jun Haeng LEE ; Jin Won KWON ; Seung Hee PARK ; Ji Hye YOU ; Ji Hyun KIM ; Chul Hyun LIM ; Joo Young CHO ; Gwang Ha KIM ; Yong Chan LEE ; Hwoon Yong JUNG ; Ji Young KIM ; Hoon Jai CHUN ; Sang Yong SEOL
Gut and Liver 2016;10(5):739-748
BACKGROUND/AIMS: Endoscopic submucosal dissection (ESD) is an effective treatment for early gastric cancer (EGC) that has demonstrated a minimal risk of lymph node metastasis in retrospective studies. We sought to prospectively evaluate the short-term outcomes of ESD treatment in EGCs. METHODS: A prospective multicenter cohort study of neoplasms 3 cm or less in diameter at endoscopic size evaluation was performed in 12 Korean ESD study group-related university hospitals and the National Cancer Center. Resected specimens were evaluated by the central pathologic review board. RESULTS: A patient cohort (n=712) with a total of 737 EGCs was analyzed. The margin-freeen bloc resection rate was 97.3%, and curative resection of 640 lesions (86.8%) was achieved. Lower curative resection rates were associated with lesions 2 to 3 cm in size prior to ESD compared with lesions 2 cm or less in size (78.6% vs 88.1%, respectively, p=0.009). Significant factors associated with noncurative resection were moderately or poorly differentiated histological type, posterior wall tumor location, tumor size larger than 3 cm, ulceration, and submucosal invasion. Delayed bleeding occurred in 49 patients (6.9%), and 12 patients (1.7%) exhibited perforations. CONCLUSIONS: ESD is an effective treatment with a high curative resection rate for EGCs that meets relatively conservative pre-ESD indications. Long-term survival outcomes should be evaluated in follow-up studies.
Cohort Studies*
;
Endoscopy
;
Follow-Up Studies
;
Hemorrhage
;
Hospitals, University
;
Humans
;
Lymph Nodes
;
Neoplasm Metastasis
;
Prospective Studies*
;
Retrospective Studies
;
Stomach Neoplasms*
;
Ulcer
7.A Thief Caught in the Act: Free Floating Venous Thrombus in the Right Heart Associated With Pulmonary Embolism.
Seung Pyo LEE ; Hyung Kwan KIM ; Song Yi KIM ; Il Young OH ; Hyun Jai CHO ; Yong Jin KIM ; Dae Won SOHN
Korean Circulation Journal 2011;41(1):51-52
No abstract available.
Heart
;
Pulmonary Embolism
;
Thrombosis
8.Staghorn Stones Combined with Transitional Cell Carcinoma of the Renal Pelvis.
Min Gyun KIM ; Jai Hyun CHUNG ; In Sung HWANG ; C One CHO ; Yong Il PARK ; Ji Hyeong YU ; Luck Hee SUNG ; Jae Yong CHUNG ; Choong Hee NOH ; Hyun Jung KIM
Korean Journal of Urology 2009;50(10):1027-1031
Longstanding, unrecognized staghorn stones remain a major cause of morbidity in the form of pain, infection, and functional impairment of the affected kidney. Squamous cell carcinoma of the upper urinary tract is associated with stone disease and chronic infection, but the association with transitional cell carcinoma (TCC) has not been proven. We report a case of a 73-year-old man presenting with right flank pain with episodes of total gross hematuria for 1 year. An abdominopelvic computed tomography scan showed decreased parenchymal enhancement and staghorn stones in the right renal pelvis and multiple tiny calyceal stones with severe hydronephrosis. The patient underwent a simple nephrectomy. Histopathologic analysis revealed staghorn stones combined with high-grade papillary TCC of the renal pelvis. The tumor was extended into the peripelvic fat and renal parenchyme (pT3NoMo).
Aged
;
Carcinoma, Squamous Cell
;
Carcinoma, Transitional Cell
;
Flank Pain
;
Hematuria
;
Humans
;
Hydronephrosis
;
Kidney
;
Kidney Pelvis
;
Nephrectomy
;
Urinary Tract
9.A Survey on the Indication for Endoscopic Submucosal Dissection in Early Gastric Cancer.
Chang Kyun LEE ; Il Kwun CHUNG ; Joo Young CHO ; Jae J KIM ; Hoon Jai CHUN ; Hyun Yong JEONG ; Sang Young SEOL
Korean Journal of Gastrointestinal Endoscopy 2009;39(2):78-84
BACKGROUND/AIMS: Endoscopic submucosal dissection (ESD) has become a widely accepted method for treating early gastric cancer (EGC) in Korea. However, there is not an established guideline for indications of ESD. The objective of this study was to assess the current status and practice patterns regarding indications for ESD in Korea. METHODS: A 17-item questionnaire about indications for ESD in EGC was presented to the participants of the 2nd joint symposium of the Gastrointestinal Pathology Study Group of the Korean Society of pathologists. Keypad-based anonymous voting was carried out and the entire process was recorded. RESULTS: Endoscopic submucosal dissection for EGC fulfilling the classical indications was widely accepted as an effective therapeutic strategy comparable to surgery (114/115, agreement 99.5%). In our survey, Japanese extended criteria for ESD was still debated (70/111, 63.6%), but most respondents had performed ESD selectively in EGC corresponding to the extended criteria (105/109, 96.3%). They agreed that the current criteria for ESD would possibly require a revision considering various clinical indicators. CONCLUSIONS: Our survey shows that there is still no consensus about indications for ESD in EGC. Therefore, more clinical outcome data with a long-term follow-up are needed to establish evidence-based consensus and guidelines for ESD indications in Korea. (
Anonyms and Pseudonyms
;
Asian Continental Ancestry Group
;
Consensus
;
Surveys and Questionnaires
;
Follow-Up Studies
;
Humans
;
Joints
;
Korea
;
Politics
;
Stomach Neoplasms
10.Analytic Study of the Patients Registered at Seoul National University Hospital Acne Clinic.
Young Joon CHO ; Dong Hun LEE ; Eun Ju HWANG ; Jai Il YOUN ; Dae Hun SUH
Korean Journal of Dermatology 2006;44(7):798-804
BACKGROUND: Acne is a common skin disorder which affects both adolescents and adults. However, there have been few Korean epidemiological studies conducted. OBJECTIVE: The purpose of this study was to analyze the prevalence, demographic factors, clinical features and aggravating factors of acne. We also investigated the relationship of these factors. METHODS: Epidemiological and clinical data was obtained by interviewing 657 acne patients, newly enrolled at Seoul National University Hospital Acne Clinic between 1996 and 2004. RESULTS: Most patients were found to have facial acne, and the forehead and cheeks were the most common sites where acne first developed. Males tended to visit the hospital because of social problems compared to females. We identified some significant correlations with sex, age of onset, disease duration, first affected site, seborrhea, and family history. Acne lesions developed earlier and disease duration was longer in the group with a family history of acne or severe seborrhea. More than 80% of patients were found to have subjective symptoms, including pain and itching which were most frequent. The degree of seborrhea was higher and the aggravation after sun exposure was more frequent in the group where complete remission of acne had not been achieved. Aggravation of acne was most frequent in summer, followed by winter. CONCLUSION: We could investigate the epidemiological and clinical features of acne patients, including the age of onset, motive of treatment, subjective symptoms, plus outcome of treatment according to remission history of acne, as these factors have never been reported in the Korean literature before.
Acne Vulgaris*
;
Adolescent
;
Adult
;
Age of Onset
;
Cheek
;
Demography
;
Dermatitis, Seborrheic
;
Epidemiologic Studies
;
Epidemiology
;
Female
;
Forehead
;
Humans
;
Male
;
Prevalence
;
Pruritus
;
Seoul*
;
Skin
;
Social Problems
;
Solar System

Result Analysis
Print
Save
E-mail