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.Feedback Survey of the Effect, Burden, and Cost of the National Endoscopic Quality Assessment Program during the Past 5 Years in Korea.
Yu Kyung CHO ; Jeong Seop MOON ; Dong Su HAN ; Yong Chan LEE ; Yeol KIM ; Bo Young PARK ; Il Kwun CHUNG ; Jin Oh KIM ; Jong Pil IM ; Jae Myung CHA ; Hyun Gun KIM ; Sang Kil LEE ; Hang Lak LEE ; Jae Young JANG ; Eun Sun KIM ; Yunho JUNG ; Chang Mo MOON
Clinical Endoscopy 2016;49(6):542-547
BACKGROUND/AIMS: In Korea, the nationwide gastric cancer screening program recommends biennial screening for individuals aged 40 years or older by way of either an upper gastrointestinal series or endoscopy. The national endoscopic quality assessment (QA) program began recommending endoscopy in medical institutions in 2009. We aimed to assess the effect, burden, and cost of the QA program from the viewpoint of medical institutions. METHODS: We surveyed the staff of institutional endoscopic units via e-mail. RESULTS: Staff members from 67 institutions replied. Most doctors were endoscopic specialists. They responded as to whether the QA program raised awareness for endoscopic quality (93%) or improved endoscopic practice (40%). The percentages of responders who reported improvements in the diagnosis of gastric cancer, the qualifications of endoscopists, the quality of facilities and equipment, endoscopic procedure, and endoscopic reprocessing were 69%, 60%, 66%, 82%, and 75%, respectively. Regarding reprocessing, many staff members reported that they had bought new automated endoscopic preprocessors (3%), used more disinfectants (34%), washed endoscopes longer (28%), reduced the number of endoscopies performed to adhere to reprocessing guidelines (9%), and created their own quality education programs (59%). Many responders said they felt that QA was associated with some degree of burden (48%), especially financial burden caused by purchasing new equipment. Reasonable quality standards (45%) and incentives (38%) were considered important to the success of the QA program. CONCLUSIONS: Endoscopic quality has improved after 5 years of the mandatory endoscopic QA program.
Diagnosis
;
Disinfectants
;
Education
;
Electronic Mail
;
Endoscopes
;
Endoscopy
;
Korea*
;
Mass Screening
;
Motivation
;
Specialization
;
Stomach Neoplasms
3.Finasteride Induced Cerebral Venous Thrombosis.
Dong Wan KANG ; Han Gil JEONG ; Hang Rai KIM ; Chan Young PARK ; Jung Min PYUN ; Do Yeon KIM ; Seung Hoon LEE
Journal of the Korean Neurological Association 2015;33(3):238-240
No abstract available.
Finasteride*
;
Risk Factors
;
Venous Thrombosis*
4.Prevalence of Gastric Subepithelial Tumors in Korea: A Single Center Experience.
Jung Hoon LEE ; Hang Lak LEE ; Yong Woo AHN ; Kang Nyeong LEE ; Dae Won JUN ; Oh Young LEE ; Dong Soo HAN ; Byung Chul YOON ; Ho Soon CHOI
The Korean Journal of Gastroenterology 2015;66(5):274-276
BACKGROUND/AIMS: The incidental finding of gastrointestinal subepithelial tumors (SETs) is increasing with national cancer screening endoscopy. In a Swedish population, screening endoscopy found a prevalence of SETs of 0.36%. However, the prevalence of gastric SETs in Korean patients has not been described. Therefore, this study evaluated the prevalence of SETs of the stomach in a Korean patient population. METHODS: We reviewed endoscopic reports of 11,712 subjects who underwent screening esophagogastroduodenoscopy (EGD) at Hanyang University Hospital between July 2012 and June 2013. RESULTS: Among 11,712 patients, 194 (1.7%) had SET of the stomach. Of these, 71 (prevalence, 0.6%) were male and 123 (prevalence, 1.1%) were female. When grouped by age, the prevalence of SET was as follows: 1.0% for patients in their twenties, 6.2% for those in their thirties, 19.1% for those in their forties, 33.0% for those in their fifties, 30.4% for those in their sixties, and 10.3% for those over 70 years of age. CONCLUSIONS: The overall prevalence of gastric SET among healthy examinees was 1.7%. The prevalence of gastric SET increased with age and was higher in female.
Adult
;
Age Factors
;
Aged
;
Asian Continental Ancestry Group
;
Early Detection of Cancer
;
Endoscopy, Digestive System
;
Female
;
Humans
;
Male
;
Middle Aged
;
Neoplasms, Glandular and Epithelial/diagnosis/*epidemiology
;
Prevalence
;
Republic of Korea/epidemiology
;
Retrospective Studies
;
Risk Factors
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Sex Factors
;
Stomach Neoplasms/diagnosis/*epidemiology
5.Ginkgo biloba extract (GbE) enhances the anti-atherogenic effect of cilostazol by inhibiting ROS generation.
In Hyuk JUNG ; You Han LEE ; Ji Young YOO ; Se Jin JEONG ; Seong Keun SONN ; Jong Gil PARK ; Keun Ho RYU ; Bong Yong LEE ; Hye Young HAN ; So Young LEE ; Dae Yong KIM ; Hang LEE ; Goo Taeg OH
Experimental & Molecular Medicine 2012;44(5):311-318
In this study, the synergistic effect of 6-[4-(1-cyclohexyl-1H-tetrazol-5-yl) butoxy]-3,4-dihydro-2(1H)-quinolinone (cilostazol) and Ginkgo biloba extract (GbE) was examined in apolipoprotein E (ApoE) null mice. Co-treatment with GbE and cilostazol synergistically decreased reactive oxygen species (ROS) production in ApoE null mice fed a high-fat diet. Co-treatment resulted in a significantly decreased atherosclerotic lesion area compared to untreated ApoE mice. The inflammatory cytokines and adhesion molecules such as monocyte chemoattractant-1 (MCP-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), and VCAM-1 which can initiate atherosclerosis were significantly reduced by the co-treatment of cilostazol with GbE. Further, the infiltration of macrophages into the intima was decreased by co-treatment. These results suggest that co-treatment of GbE with cilostazol has a more potent anti-atherosclerotic effect than treatment with cilostazol alone in hyperlipidemic ApoE null mice and could be a valuable therapeutic strategy for the treatment of atherosclerosis.
Animals
;
Apolipoproteins E/genetics/physiology
;
Atherosclerosis/*drug therapy
;
Cytokines/metabolism
;
Disease Models, Animal
;
Drug Synergism
;
Ginkgo biloba/*chemistry
;
Humans
;
Macrophages/cytology/drug effects
;
Male
;
Mice
;
Mice, Nude
;
Plant Extracts/*administration & dosage/chemistry
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Reactive Oxygen Species/*metabolism
;
Tetrazoles/*administration & dosage
6.An Objective Assessment Scale for "Come-to-Sit" Using a Specifically Designed Jacket in Stroke Patients.
Jun Ho LEE ; Han Young JUNG ; Jae Woo LEE ; Kyung Lim JOA ; Jae Hong KIM ; Myung Jong KIM ; Do Hang HUR ; Eun Ju JANG ; Myeong Ok KIM
Annals of Rehabilitation Medicine 2012;36(1):8-15
OBJECTIVE: To compare an objective assessment scale for "come-to-sit" in stroke patients with the previously established subjective assessment scales of "performance-based assessment" and the "ability for basic movement scale". METHOD: A specifically designed jacket was used to determine the objective degree of assistance needed for patients to perform the task. While patients were sitting up, the investigator evaluated the amount of assistance needed in a fully dependent state (A) and with maximal effort (B). Using this measure, we obtained an objective scale, {(A-B)/A} x100. In addition, patients were tested in two starting positions: hemiplegic-side lying and sound-side lying. We then compared the objective scale with subjective scales and other parameters related to functional outcomes. RESULTS: For both starting positions, the objective assessment scale showed high correlation with the previously established subjective scales (p<0.01). Only the hemiplegic-side lying-to-sit objective scale showed a significant correlation with the parameters used to assess functional outcomes (p<0.05). In terms of Brunnstrom stages, only the leg stage showed a significant correlation with the objective "come-to-sit" scale (p<0.01). CONCLUSION: The objective scale was comparable to established subjective assessment scales when used by an expert. The hemiplegic-side lying-to-sit maneuver had a high correlation with patient's functional recovery. Specifically, balance and lower extremity function appear to be important factors in the "come-to-sit" activity.
Deception
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Humans
;
Leg
;
Lower Extremity
;
Research Personnel
;
Stroke
;
Weights and Measures
7.A Case of Warfarin-Induced Intramural Hematoma Diagnosed by Double-Balloon Enteroscopy.
Dong Hwi RIM ; Chang Soo EUN ; Shin Jae MOON ; Jung Ho BAE ; Tae Yeob KIM ; Hang Lak LEE ; Joo Hyun SOHN ; Yong Cheol JEON ; Dong Soo HAN
Intestinal Research 2011;9(2):162-165
Although bleeding is a major complication of oral anticoagulant therapy, warfarin-induced spontaneous intramural hematoma of the small bowel is a very rare complication. The clinical features of spontaneous intramural hematoma vary from mild abdominal pain to panperitonitis due to bowel perforation. Because spontaneous intramural hematoma can proceed to a life threatening situation, early diagnosis is of vital importance. Although there are a number of radiologic diagnostic tools available including abdominal ultrasonography and computed tomography, confirmation of the diagnosis through direct visualization of the involved bowel mucosa is very helpful. Direct confirmation of warfarin-induced spontaneous intramural hematoma of the small bowel is possible using double-balloon enteroscopy. We report a case of warfarin-induced spontaneous intramural hematoma with a review of the relevant literature.
Abdominal Pain
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Double-Balloon Enteroscopy
;
Early Diagnosis
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Hematoma
;
Hemorrhage
;
Mucous Membrane
8.A Case of Gastric Adenocarcinoma Arising from Ectopic Pancreas showing Gastric Outlet Obstruction.
Suk Hyun JUNG ; Hang Lak LEE ; Seung Sam PAIK ; Hulin HAN ; Tae Kyung HA ; Byeong Bae PARK ; Chang Ryeol CHOI ; Soon Young SONG
Korean Journal of Gastrointestinal Endoscopy 2011;42(6):373-377
An ectopic pancreas in the gastrointestinal tract is mostly found incidentally and its malignant transformation is extremely rare. We report herein a rare case of malignant transformation of ectopic pancreas in the stomach, associated with gastric outlet obstruction. A 69-year-old woman was admitted to our hospital, complaining of vomiting. Esophagogastroduodenoscopy revealed an encircling submucosal tumor-like lesion on the prepyloric antrum showing outlet obstruction. Abdominal CT showed an enhancing mass on the antrum and PET CT showed hypermetabolic wall thickening. So we performed a subtotal gastrectomy. Surgical specimens showed a moderately differentiated ductal adenocarcinoma, and the tumor cells were strongly positive for cytokeratin 7. The tumor was located close to the ectopic pancreas tissue. The tumor showed subserosal and omental invasion. There was one lymph node metastasis and no distant metastasis. The patient is being followed up in the outpatient department.
Adenocarcinoma
;
Aged
;
Carcinoma, Pancreatic Ductal
;
Endoscopy, Digestive System
;
Female
;
Gastrectomy
;
Gastric Outlet Obstruction
;
Gastrointestinal Tract
;
Humans
;
Keratin-7
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Lymph Nodes
;
Neoplasm Metastasis
;
Outpatients
;
Pancreas
;
Stomach
;
Stomach Neoplasms
;
Vomiting
9.Synchrotron Microangiography of the Rat Heart Using the Langendorff Model.
Woong Han KIM ; Se Hoon CHOI ; Jae Gun KWAK ; Dong Jin KIM ; Se Jin OH ; Dong Jung KIM ; Woo Sung JANG ; Jae Hang LEE ; Eun Suk CHOI ; Young Jun KIM
Korean Circulation Journal 2008;38(9):462-467
BACKGROUND AND OBJECTIVES: The ability to study microvessels of a beating heart in real time at the level of the capillary is essential for research. However, there are no proven methods currently available to achieve this. The conventional absorption-contrast agents have limitations for studying capillaries. Microangiography with using synchrotron phase-contrast X-ray technology and no contrast agent has recently been reported on. We tried to verify this previous report, and we wanted to visualize the microvessels of a rat heart using air as a contrast agent. MATERIALS AND METHODS: We made the Langendorff apparatus in a hutch of the Pohang Accelerator Laboratory. The images were obtained with a white beam and a monochromatic beam. The visual images were magnified using 3x and 20x optical microscope lenses, and the images were captured with a charge-coupled device camera. RESULTS: We could not duplicate the previously reported findings in which microvessels were visualized without the use of contrast agent. But with using air as a contrast agent, the microvasculature of rat hearts was clearly identified at a spatial resolution of 1.2 microm. Air being absorbed inside a capillary was also observed. Vessels under 10 microm diameter were unable to be visualized with using iodine as a contrast agent. CONCLUSION: Phase contrast imaging already allows spatial resolution of 1 microm, which is enough to inspect capillaries. We were able to obtain images of cardiac capillaries with using air as a contrast agent. Yet air has the fatal limitations in that it causes embolism and ischemia. A more suitable contrast agent or imaging method needs to be developed in order to study the microvessels of a beating heart.
Animals
;
Capillaries
;
Contrast Media
;
Embolism
;
Heart
;
Humans
;
Iodine
;
Ischemia
;
Microvessels
;
Rats
;
Synchrotrons
10.Clinical Outcomes of Lateral Internal Sphincterotomy for Patients with Chronic Anal Fissure.
Jung Soo PARK ; Jae Bum LEE ; Tae Sun KIM ; Hang Jun CHO ; Do Sun KIM ; Doo Han LEE
Journal of the Korean Society of Coloproctology 2007;23(5):292-296
PURPOSE: A lateral internal sphincterotomy (LIS) is a safe and effective surgical treatment that is the most commonly used one for patients with chronic anal fissure. However, reports on the recurrence rate and complications after LIS published in Korea are rare. The purpose of our study is to identify the types and rates of recurrence, the complications after LIS, and the differences in clinical outcomes between open and closed LIS. RESULTS: We used hospital records and telephone interviews to study retrospectively the rates of recurrence and complications of 898 patients who underwent a LIS for chronic anal fissure from July, 2003, to June 30, 2004. RESULTS: There were 292 male (mean age: 36.8 years, range: 16~84) and 606 female (mean age: 32.4 years, range: 1~68) patients. The preoperative mean maximum resting pressure in anal manommetry was 99.2 cmH2O in male patients and 97.7 cmH2O in female patients. Recurrence of fissure after LIS was present in five cases (0.6%). All underwent a LIS, on the same side of a previous LIS in four cases and on the opposite side in one case. Delayed healing of the fissure was present in six cases (0.7%). All of these patients were improved by conservative management. Complications of the LIS were thrombus formation, perianal abscess, fistula, and incontinence. Thrombus formation was present in eight cases (0.9%). Five patients underwent a thrombectomy and three patients were cured by conservative management. Perianal abscess or fistula was present in three patients (0.3%), who underwent incision and drainage or a simple fistulotomy. Incontinence was present in two cases (0.2%). One patient was lost to follow up, and the other patient was improved by conservative management. CONCLUSIONS: LIS is a safe and effective treatment for patients with chronic anal fissure, and recurrence and complications of LIS are rare.
Abscess
;
Drainage
;
Female
;
Fissure in Ano*
;
Fistula
;
Hospital Records
;
Humans
;
Interviews as Topic
;
Korea
;
Lost to Follow-Up
;
Male
;
Recurrence
;
Retrospective Studies
;
Thrombectomy
;
Thrombosis

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