1.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).
2.Clinical Features and Awareness of Hand Eczema in Korea.
Jae Beom PARK ; Seung Ho LEE ; Kea Jeung KIM ; Ga Young LEE ; Jun Mo YANG ; Do Won KIM ; Seok Jong LEE ; Cheol Heon LEE ; Eun Joo PARK ; Kyu Han KIM ; Hee Chul EUN ; Sung Eun CHANG ; Kee Chan MOON ; Seong Hyun KIM ; Seong Jin KIM ; Byung Soo KIM ; Jun Young LEE ; Hyung Ok KIM ; Hoon KANG ; Min Geol LEE ; Soo Chan KIM ; Young Suck RO ; Joo Yeon KO ; Mi Youn PARK ; Myung Hwa KIM ; Jeong Hyun SHIN ; Hae Young CHOI ; Chang Kwun HONG ; Sung Yul LEE ; Hana BAK ; Sang Wook SON ; Ai Young LEE
Annals of Dermatology 2016;28(3):335-343
BACKGROUND: Hand eczema is one of the most common skin disorders and negatively affects quality of life. However, a large-scale multicenter study investigating the clinical features of patients with hand eczema has not yet been conducted in Korea. OBJECTIVE: To identify the prevalence of various hand diseases, which is defined as all cutaneous disease occurring in hands, and to investigate the clinical features of patients with hand eczema and the awareness about hand eczema in the general population and to compare the prevalence of hand eczema between health care providers and non-health care providers. METHODS: To estimate the prevalence of hand diseases, we analyzed the medical records of patients from 24 medical centers. Patients were assessed by online and offline questionnaires. A 1,000 from general population and 913 hand eczema patients answered the questionnaire, for a total of 1,913 subjects. RESULTS: The most common hand disease was irritant contact dermatitis. In an online survey, the lifetime prevalence of hand eczema was 31.2%. Hand eczema was more likely to occur in females (66.0%) and younger (20~39 years, 53.9%). Health care providers and housewives were the occupations most frequently associated with hand eczema. Winter (33.6%) was the most common season which people experienced aggravation. The 63.0% and 67.0% answered that hand eczema hinders their personal relationship and negatively affects daily living activities, respectively. CONCLUSION: Hand eczema is a very common disease and hinders the quality of life. The appropriate identification of hand eczema is necessary to implement effective and efficient treatment.
Activities of Daily Living
;
Dermatitis, Contact
;
Eczema*
;
Female
;
Hand*
;
Health Personnel
;
Humans
;
Korea*
;
Medical Records
;
Occupations
;
Prevalence
;
Quality of Life
;
Seasons
;
Skin
;
Surveys and Questionnaires
3.A Clinical and Epidemiological Study of Scabies in Korea: A Multicenter Prospective Study.
Song Youn PARK ; Joo Young ROH ; Jun Young LEE ; Do Won KIM ; Tae Jin YOON ; Woo Young SIM ; Kyu Suk LEE ; Young Chul KYE ; Ai Young LEE ; Moon Bum KIM ; Soyun CHO ; Kee Chan MOON ; Jun Mo YANG ; Eun So LEE ; Won Soo LEE ; Min Geol LEE ; Seok Don PARK ; Young Ho WON ; Bong Seok SHIN ; Chang Kwun HONG ; Jeunghoon LEE ; Tae Young YOON ; Kwang Joong KIM ; Young Suck RO ; Ki Ho KIM ; Hee Chul EUN
Korean Journal of Dermatology 2014;52(7):457-464
BACKGROUND: Scabies is an old and common contagious skin disease. The incidence of scabies has decreased through the economic growth of Korea. However, recent outbreaks in medical facilities have created a suspicion that the infection of scabies is an emerging public health problem. OBJECTIVE: We evaluated the epidemiological and clinical aspects of patients diagnosed with scabies in Korea. This prospective study follows the retrospective study already performed by the same authors in 2011. METHODS: A multicenter, prospective study of scabies was performed at 25 hospitals in Korea. We included 914 patients who were diagnosed with scabies. Microscopic examination revealed scabies mites or eggs, or clinical improvement after treatment. Patients were asked to provide information on scabies, especially regarding the contact source, and the physicians examined them. RESULTS: Of the participants, 432 patients were men and 482 were women. Patients aged younger than 10 years and 60~69 years were the most common groups. Scabies more commonly affected patients during the fall and winter. Of the patients, 68.0% were thought to be infected at their homes, followed by nursing homes or hospitals (25.7%), and 31.6% through contact with other patients or, occasionally, staff members, including caregivers. CONCLUSION: We confirmed that scabies is an emerging threat in institutions, especially medical facilities. In addition, we suggest that public and in-hospital education is essential to minimize the problems associated with scabies.
Caregivers
;
Disease Outbreaks
;
Economic Development
;
Education
;
Eggs
;
Epidemiologic Studies*
;
Epidemiology
;
Female
;
Humans
;
Incidence
;
Korea
;
Male
;
Mites
;
Nursing Homes
;
Ovum
;
Prospective Studies*
;
Public Health
;
Scabies*
;
Skin Diseases
4.Epidemiological and Clinical Study of Scabies in Korea: Multicenter Retrospective Study.
Song Youn PARK ; Jong Soo HONG ; Joo Young ROH ; Jun Young LEE ; Do Won KIM ; Tae Jin YOON ; Woo Young SIM ; Kyu Suk LEE ; Young Chul KYE ; Ai Young LEE ; Moon Bum KIM ; Soyun CHO ; Kee Chan MOON ; Jun Mo YANG ; Eun So LEE ; Won Soo LEE ; Min Geol LEE ; Seok Don PARK ; Young Ho WON ; Bong Seok SHIN ; Chang Kwun HONG ; Jeunghoon LEE ; Tae Young YOON ; Kwang Joong KIM ; Young Suck RO ; Ki Ho KIM ; Hee Chul EUN
Korean Journal of Dermatology 2013;51(9):678-684
BACKGROUND: Scabies is one of the common skin diseases observed in developing countries. The incidence of scabies has decreased dramatically since the late 1980s in Korea. However, recent outbreaks in nursing homes or hospitals have been raising public health concerns. OBJECTIVE: We intended to evaluate the epidemiological and clinical aspects of patients diagnosed with scabies in Korea. In particular, we tried to investigate the changing trend of contact sources in our society. METHODS: A multi-center cross sectional study was performed at 25 hospitals in Korea. We included 1,539 patients who were diagnosed with scabies. These patients showed scabies mites or eggs under microscopic examination, or clinical improvement after treatment. Their medical records with information of contact sources were reviewed. RESULTS: Six hundred and ninety-three patients were males and 826 were females. Patients' age from 70 to 79 was the most common followed by patients below 10 years of age. More patients were found in the fall and winter months. 66.7% of patients were thought to be infected at their homes which were situated next to nursing homes or hospitals (23.1%). Place of infection could not be verified in 39.3% of patients. 25.8% of patients were suggested to be infected through contact with medical staff or patients from hospitals or nursing homes. CONCLUSION: We confirmed that the contact sources of scabies are changing in our society; nursing homes and hospitals are emerging sources of infection. The majority of patients are old or very young who are vulnerable to many diseases. Therefore, dermatologists should pay attention to new contact sources and appropriate care of patients.
Developing Countries
;
Disease Outbreaks
;
Eggs
;
Female
;
Humans
;
Hypogonadism
;
Incidence
;
Korea
;
Male
;
Medical Records
;
Medical Staff
;
Mites
;
Mitochondrial Diseases
;
Nursing Homes
;
Ophthalmoplegia
;
Ovum
;
Public Health
;
Retrospective Studies
;
Scabies
;
Skin Diseases
5.Efficacy and safety of entecavir plus carnitine complex (GODEX(R)) compared to entecavir monotherapy in patient with ALT elevated chronic hepatitis B: randomized, multicenter open-label trials. The GOAL study.
Dae Won JUN ; Byung Ik KIM ; Yong Kyun CHO ; Hong Ju KIM ; Young Oh KWON ; Soo Young PARK ; Sang Young HAN ; Yang Hyun BAEK ; Yong Jin JUNG ; Hwi Young KIM ; Won KIM ; Jeong HEO ; Hyun Young WOO ; Seong Gyu HWANG ; Kyu Sung RIM ; Jong Young CHOI ; Si Hyun BAE ; Young Sang LEE ; Young Suck LIM ; Jae Youn CHEONG ; Sung Won CHO ; Byung Seok LEE ; Seok Hyun KIM ; Joo Hyun SOHN ; Tae Yeob KIM ; Yong Han PAIK ; Ja Kyung KIM ; Kwan Sik LEE
Clinical and Molecular Hepatology 2013;19(2):165-172
BACKGROUND/AIMS: Carnitine and vitamin complex (Godex(R)) is widely used in patients with chronic liver disease who show elevated liver enzyme in South Korea. The purpose of this study is to identify the efficacy and safety of carnitine from entecavir combination therapy in Alanine aminotransferase (ALT) elevated Chronic Hepatitis B (CHB) patients. METHODS: 130 treatment-naive patients with CHB were enrolled from 13 sites. The patients were randomly selected to the entecavir and the complex of entecavir and carnitine. The primary endpoint of the study is ALT normalization level after 12 months. RESULTS: Among the 130 patients, 119 patients completed the study treatment. The ALT normalization at 3 months was 58.9% for the monotherapy and 95.2% for the combination therapy (P<0.0001). ALT normalization rate at 12 months was 85.7% for the monotherapy and 100% for the combination group (P=0.0019). The rate of less than HBV DNA 300 copies/mL at 12 months was not statistically significant (P=0.5318) 75.9% for the monotherapy, 70.7% for the combination and it was. Quantification of HBsAg level was not different from the monotherapy to combination at 12 months. Changes of ELISPOT value to evaluate the INF-gamma secretion by HBsAg showed the increasing trend of combination therapy compare to mono-treatment. CONCLUSIONS: ALT normalization rate was higher in carnitine complex combination group than entecavir group in CHB. Combination group was faster than entecavir mono-treatment group on ALT normalization rate. HBV DNA normalization rate and the serum HBV-DNA level were not changed by carnitine complex treatment.
Adult
;
Alanine Transaminase/blood
;
Antiviral Agents/*therapeutic use
;
Carnitine/*therapeutic use
;
DNA, Viral/analysis
;
Drug Therapy, Combination
;
Enzyme-Linked Immunospot Assay
;
Female
;
Guanine/*analogs & derivatives/therapeutic use
;
Hepatitis B Surface Antigens/blood
;
Hepatitis B e Antigens/blood
;
Hepatitis B virus/genetics
;
Hepatitis B, Chronic/*drug therapy
;
Humans
;
Interferon-gamma/metabolism
;
Male
;
Middle Aged
;
Mitochondria/physiology
;
Treatment Outcome
;
Vitamin B Complex/*therapeutic use
6.A Case of Delayed Fatal Hemobilia after Radiofrequency Ablation of Hepatocellular Carcinoma.
Seung Kyu CHUNG ; Baek Gyu JUN ; Sae Hwan LEE ; Suck Ho LEE ; Il Kwun CHUNG ; Hong Soo KIM ; Sang Heum PARK ; Sun Joo KIM
Soonchunhyang Medical Science 2012;18(1):52-55
Radiofrequency ablation (RFA) has been accepted as a safe and effective treatment for unresectable hepatic tumors because of the advantages of a minimally invasive procedure and the local treatment effect. Although RFA can be performed safely in most patients, early and late complications related to mechanical or thermal damage may be observed at follow-up examination. Hemobilia is a very rare complication of RFA and most hemobilia is an immediate complication. However, delayed hemobilia is an even more rare complication after RFA and is known to be a fatal complication. We present a case of delayed fatal hemobilia after RFA for hepatocellular carcinoma.
Carcinoma, Hepatocellular
;
Follow-Up Studies
;
Hemobilia
;
Humans
7.TRUE Test in Patients with Contact Dermatitis: A Multicenter Study.
Yeon Ju HONG ; Hae Young CHOI ; Kea Jeung KIM ; Ga Young LEE ; Do Won KIM ; Seong Jin KIM ; Soo Chan KIM ; Young Suck RO ; Kee Chan MOON ; Mi Youn PARK ; Sang Wook SON ; Jeong Hyun SHIN ; Jun Mo YANG ; Hee Chul EUN ; Min Geol LEE ; Cheol Heon LEE ; Chang Kwun HONG
Korean Journal of Dermatology 2011;49(8):661-669
BACKGROUND: The TRUE test is a commercially available ready-to-apply patch test widely used in many countries, but no large-scale study is available on the TRUE test in Korea. OBJECTIVE: The purpose of this study was to analyze the type, frequency, and changes in the common contact allergens in Korea using the TRUE test. METHODS: From January 2009 to March 2010, TRUE tests were performed on patients with contact dermatitis at the Departments of Dermatology of 15 hospitals. The epidemiological findings of patients, and the results of the patch tests were analyzed. RESULTS: In total, 795 patch tested cases (246 males, 549 females) were compiled and analyzed. The oldest age distribution was the third decade in both males and females, and housewives and office-workers were the most common jobs, comprising 29.7% and 19.8% of the occupations, respectively. Overall, 65.1% of patients had at least one positive reaction, and the most common allergens were nickel sulfate (34.1%), thimerosal (12.6%), cobalt chloride (11.1%), and p-phenylenediamine (8.4%), in order of frequency. A univariate analysis of multiple variables including age, gender, occupation, and affected sites was conducted and a comparison with a previous multicenter study was also analyzed. CONCLUSION: These results provide the basis for use of the TRUE test in patients with contact dermatitis in Korea.
Age Distribution
;
Allergens
;
Cobalt
;
Dermatitis, Contact
;
Dermatology
;
Female
;
Humans
;
Korea
;
Male
;
Nickel
;
Occupations
;
Patch Tests
;
Phenylenediamines
;
Thimerosal
8.A Case of Primary Duodenal Cancer on Afferent Loop Presenting with Chronic Anemia and Recurrent Melena.
Baek Gyu JUN ; Tae Hoon LEE ; Hyun Wook CHO ; Sae Hwan LEE ; Suck Ho LEE ; Il Kwun CHUNG ; Hong Soo KIM ; Sang Heum PARK ; Sun Joo KIM ; Hyun Deuk CHO
Soonchunhyang Medical Science 2011;17(1):49-52
Obscure gastrointestinal bleeding accounts for approximately 5% of all gastrointestinal bleeding. Angioectasia of the small bowel is the most common form of obscure gastrointestinal bleeding, while small bowel tumors are the second. Among small bowel tumors, primary duodenal cancer is uncommon and represents 0.3% of gastrointestinal tumors. However, primary duodenal cancer at the duodenal stump following Billroth II gastrectomy for stomach cancer is extremely rare, and have not been reported yet in Korea. We report the first case of a 74-year-old man with chronic anemia and recurrent melena, which was diagnosed as a primary duodenal adenocarcinoma developed in afferent loop. The primary lesion was successfully accessed under cap-fitted endoscopy, however final diagnosis was delayed due to the unusual anatomical site.
Adenocarcinoma
;
Afferent Loop Syndrome
;
Aged
;
Anemia
;
Duodenal Neoplasms
;
Endoscopy
;
Gastrectomy
;
Gastroenterostomy
;
Hemorrhage
;
Humans
;
Korea
;
Melena
;
Stomach Neoplasms
9.A Single Institution's Experience of Ten Pediatric Patients with Endoscopic Retrograde Cholangiopancreatography.
Jin Woo PARK ; Sang Heum PARK ; Tae Hoon LEE ; Yun Suk SHIM ; Soon Oh HWANG ; Sang Pil KIM ; Jun Young LEE ; Seo Whan LEE ; Chang Kwun LEE ; Do Hyun PARK ; Suck Ho LEE ; Il Kwun CHUNG ; Hong Soo KIM ; Sun Joo KIM
Korean Journal of Gastrointestinal Endoscopy 2010;41(3):140-146
BACKGROUND/AIMS: ERCP is being used increasingly as a diagnostic and therapeutic tool for children with pancreaticobiliary disorders. Differences between thirteen pediatric ERCPs and adult ERCPs were reviewed with respect to their indications, method of anesthesia, choice of endoscope and complications. METHODS: The medical records of 13 ERCPs for 10 children (age: 23 months to 14 years) done between 2005 and 2008 were reviewed retrospectively. RESULTS: ERCP was indicated for gallstone pancreatitis (6), choledocholithiasis (3), and unexplained pain (1). The method of anesthesia was intravenous sedation with a single agent or a combination of midazolam, propofol or ketamine. The quality of sedation was satisfactory in 10 cases and unsatisfactory in three cases. These 3 cases were less than 8 years old and sedated with a combination of midazolam and propofol. Selective biliary cannulation was successful in 92.3% (12/13) of attempts. Therapeutic ERCP included sphincterotomy (4), endoscopic papillary balloon dilatation (3), and both (5). Complications occurred in 7.7% of attempts (1/13; 1 duodenal perforation) which was successfully managed by surgery. CONCLUSIONS: Pediatric ERCP is a feasible and useful technique. Special caution is needed, however, because of differences with adult ERCP in terms of the effectiveness of intravenous sedation, complications, and size of the gastrointestinal tract.
Adult
;
Anesthesia
;
Catheterization
;
Child
;
Cholangiopancreatography, Endoscopic Retrograde
;
Choledocholithiasis
;
Dilatation
;
Endoscopes
;
Gallstones
;
Gastrointestinal Tract
;
Humans
;
Ketamine
;
Medical Records
;
Midazolam
;
Pancreatitis
;
Propofol
;
Retrospective Studies
10.Accelerated Hyperfractionated Radiotherapy for Locally Advanced Uterine Cervix Cancers.
Young Seok SEO ; Chul Koo CHO ; Seong Yul YOO ; Mi Sook KIM ; Kang Mo YANG ; Hyung Jun YOO ; Chul Won CHOI ; Kyung Hee LEE ; Eui Don LEE ; Sang Young RHU ; Suck Chul CHOI ; Moon Hong KIM ; Beob Jong KIM
The Journal of the Korean Society for Therapeutic Radiology and Oncology 2008;26(1):24-34
PURPOSE: To assess the efficacy of the use of accelerated hyperfractionated radiotherapy (AHRT) for locally advanced uterine cervix cancers. MATERIALS AND METHODS: Between May 2000 and September 2002, 179 patients were identified with FIGO stage IIB, IIIB, and IVA cancers. Of the 179 patients, 45 patients were treated with AHRT (AHRT group) and 134 patients were treated with conventional radiotherapy (CRT group), respectively. Patients undergoing the AHRT regimen received a dose of 30 Gy in 20 fractions (1.5 Gyx2 fractions/day) to the whole pelvis. Subsequently, with a midline block, we administered a parametrial boost with a dose of 20 Gy using 2 Gy fractions. Patients also received two courses of low-dose-rate brachytherapy, up to a total dose of 85~90 Gy to point A. In the CRT group of patients, the total dose to point A was 85~90 Gy. The overall treatment duration was a median of 37 and 66 days for patients that received AHRT and CRT, respectively. Statistical analysis was calculated by use of the Kaplan-Meier method, the log-rank test, and Chi-squared test. RESULTS: For patients that received cisplatin-based concurrent chemotherapy and radiotherapy, the local control rate at 5 years was 100% and 79.2% for the AHRT and CRT group of patients, respectively (p=0.028). The 5-year survival rate for patients with a stage IIB bulky tumor was 82.6% and 62.1% for the AHRT group and CRT group, respectively (p=0.040). There was no statistically significant difference for severe late toxicity between the two groups (p=0.561). CONCLUSION: In this study, we observed that treatment with AHRT with concurrent chemotherapy allows a significant advantage of local control and survival for locally advanced uterine cervix cancers.
Chemoradiotherapy

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