1.Phase III Clinical Trial of Revaprazan (Revanex(R)) for Gastric Ulcer.
Rin CHANG ; In Sik CHUNG ; Soo Heon PARK ; Sung Kook KIM ; Seok Reyol CHOI ; Geun Am SONG ; Ki Baik HAHM ; Yong Chan LEE ; Hyun Soo KIM ; Tae Nyeun KIM ; Suck Chei CHOI ; Sang Yong SEOL ; Jong Sun REW ; Dong Joon KIM ; Jin LEE ; Ho Soon CHOI ; Jung Eun LEE ; Geun Seog SONG ; Byoung Seok MOON ; Sang Aun JOO
Korean Journal of Gastrointestinal Endoscopy 2007;34(6):312-319
BACKGROUND/AIMS: This randomized, double-blind, phase III, multicenter trial was carried out to compare the efficacy and safety of revaprazan, a novel acid pump antagonist, with that of omeprazole in patients with more than one of gastric ulcers. METHODS: Two hundred and ninety two subjects were randomized to 4~8 weeks of treatment with either revaprazan 200 mg or omeprazole 20 mg. The primary efficacy parameter was the cumulative healing rate determined by endoscopy after 4 and 8 weeks of treatment, and the secondary efficacy parameter was an improvement rate of pain. RESULTS: The intention-to-treat analysis revealed revaprazan and omeprazole to have similar cumulative healing rates (93.0% and 89.6%, respectively; p=0.3038). The per-protocol analysis revealed revaprazan and omeprazole to also have similar cumulative healing rates (99.1% and 100%, respectively; p= 0.3229). In both analyses, there were no significant differences in an improvement rate of pain between the two groups. Both drugs were well tolerated. CONCLUSIONS: Revaprazan has similar efficacy to omeprazole in the treatment of patients with gastric ulcer with a once a day application of revaprazan 200 mg or omeprazole 20 mg over a 4 to 8-week period. In terms of safety, revaprazan was well tolerated.
Endoscopy
;
Humans
;
Omeprazole
;
Stomach Ulcer*
2.Phase III Clinical Trial of Revaprazan (Revanex(R)) for Gastritis.
Myung Gyu CHOI ; Soo Heon PARK ; Sung Kook KIM ; Rin CHANG ; Seok Reyol CHOI ; Geun Am SONG ; Ki Baik HAHM ; Yong Chan LEE ; Hyun Soo KIM ; Tae Nyeun KIM ; Suck Chei CHOI ; Sang Yong SEOL ; Jong Sun REW ; Dong Joon KIM ; Jin LEE ; Ho Soon CHOI ; Ju Yeon JEONG ; Geun Seog SONG ; Byoung Seok MOON ; Sang Aun JOO
Korean Journal of Gastrointestinal Endoscopy 2006;33(4):212-219
BACKGROUND/AIMS: We performed a randomized, double-blind, phase III, multicenter trial to assess the comparative efficacy and safety of revaprazan, which is a novel acid pump antagonist in comparison with ranitidine for treating patients suffering with acute gastritis and acute aggravation of chronic gastritis. METHODS: Five hundred and twelve subjects were randomized to 2 weeks of treatment with either revaprazan 200 mg q.d. or ranitidine 150 mg b.i.d. The primary efficacy parameter was the estimated improvement rate according to endoscopy, and the secondary efficacy parameter was the improvement rate for the subjects' symptoms. RESULTS: The estimated improvement rates at 2 weeks (intention-to-treat analysis) were 79.9% with revaprazan and 60.5% with ranitidine; a significant difference was found between the two groups (p<0.0001). On the per-protocol analysis, the estimated improvement rates for revaprazan and ranitidine were 79.4% and 60.2%, respectively. There was a significant difference in the estimated improvement rates between the two groups (p<0.0001). On both analyses, there were no significant differences between the two groups for the improvement rates of the subjects' symptoms. Both drugs were well tolerated. CONCLUSIONS: The efficacy of revaprazan was higher than that of ranitidine for the estimated improvement rate according to endoscopy and also for the symptomatological improvement rate, and revaprazan was well tolerated by the subjects suffering with gastritis.
Endoscopy
;
Gastritis*
;
Humans
;
Ranitidine
3.Revaprazan (Revanex(R)), a Novel Acid Pump Antagonist, for Duodenal Ulcer: Results of a Double-Blind, Randomized, Parallel, Multi-Center Phase III Clinical Trial.
In Sik CHUNG ; Myung Gyu CHOI ; Soo Heon PARK ; Sung Kook KIM ; Rhyn CHANG ; Jin Hai HYUN ; Sang Young HAN ; Geun Am SONG ; Chan Sup SHIM ; Ki Baik HAHM ; Hyun Soo KIM ; Tae Nyeun KIM ; Suck Chei CHOI ; Sang Yong SEOL ; Jong Sun REW ; Dong Joon KIM ; Jin LEE ; Ho Soon CHOI ; Geun Seog SONG ; Byoung Seok MOON ; Sang Aun JOO
Korean Journal of Gastrointestinal Endoscopy 2005;31(1):17-24
BACKGROUND/AIMS: To assess the comparative efficacy and safety of revaprazan, a novel acid pump antagonist, versus omeprazole in patients with duodenal ulcer, we performed a randomized, double-blind, phase III, multicenter trial. METHODS: Two hundred and twenty eight patients were randomized to 4 weeks of treatment with either revaprazan 200 mg or omeprazole 20 mg once daily. Primary efficacy parameter was complete ulcer healing by endoscopy, and secondary parameter was the improvement in the severity of daytime and nighttime pain. RESULTS: Healing rates at 4 weeks (intention-to-treat analysis) were 91.7% with revaprazan 200 mg and 91.3% with omeprazole 20 mg; there were no significant differences between two groups (p=0.9228). In per-protocol analysis, healing rates of revaprazan 200 mg and omeprazole 20 mg were 94.4% and 92.3%, respectively. There was no significant difference in healing rate between two groups (p=0.5666). There was no significant difference between two groups in improvement rates of daytime and nighttime pain. Both drugs were well tolerated. CONCLUSIONS: Revaprazan 200 mg was equivalent to omeprazole 20 mg for both ulcer healing and symptom relief, and was well tolerated in patients with duodenal ulcer.
Duodenal Ulcer*
;
Endoscopy
;
Humans
;
Omeprazole
;
Ulcer
4.A Case of Ascites by Pseudomembranous Colitis, Initially Diagnosed Malignant Asites.
Chang Uck KIM ; Jin Won CHO ; Jin Young SONG ; Do Kyun JIN ; Su Jin HONG ; Sea Hyub KAE ; Jin LEE ; Sang Aun JOO
Korean Journal of Gastrointestinal Endoscopy 2001;22(4):225-228
Pseudomembranous colitis (PMC) is mostly related with the antibiotics and it presents with diarrhea, abdominal pain, fever, hypoalbuminemia and hypovolemia. In the clinical course of pseudomembranous colitis (PMC), ascites is a rare presentation, and high elevation of carcinoembryonic antigen (CEA) associated with PMC is also a very rare presentation. We experienced a case taken cephalosporin group antibiotics for six weeks and presented with fever, abdominal pain, severe diarrhea, and massive ascites. During evaluation, we found low serum-ascites albumin gradient and high level of CEA in both ascites and plasma. With the impression of hidden malignancy, the special studies were done, but PMC was only found without malignancy. After vancomycin therapy, all symptoms were relieved and CEA level declined.
Abdominal Pain
;
Anti-Bacterial Agents
;
Ascites*
;
Carcinoembryonic Antigen
;
Diarrhea
;
Enterocolitis, Pseudomembranous*
;
Fever
;
Hypoalbuminemia
;
Hypovolemia
;
Plasma
;
Vancomycin
5.The LDH to AST ratio as an indicator of pancreatic necrosis in acute biliary and alcoholic pancreatitis.
Jung Han KIM ; Chang Uck KIM ; Hyun Joo JANG ; Won Jong BAHK ; Jin Cheol PARK ; Seung Sick KANG ; Sea Hyub KAE ; Jin LEE ; Yong Bum KIM ; Sang Aun JOO
Korean Journal of Medicine 2000;58(2):161-169
BACKGROUND: Lactate dehydrogenase (LDH) has been reported to be a sensitive indicator of pancreatic necrosis (PN), and some studies suggested that an elevation of the ratio of LDH to AST (LDH/AST ratio) woud be more accurate indicator of PN in acute biliary pncreatitis (BP). However, there were no studies in alcoholic pancreatitis (AP). The aim of this study was to assess the clinical usefulness of LDH/AST ratio in alcoholic pancreatitis (AP) as a indicator of PN. METHODS: On the basis of CT scan findings, the patients were categorized into two groups as having PN or non-PN. The plasma levels of the LDH, AST and LDH/AST ratio over two weeks postadmission period were evaluated and compared with in two groups of patients with BP (consiting of 12 PN and 34 non-PN patients), and with AP (consisting of 14 PN and 38 non-PN patients). RESULTS: In acute BP, on post-admission days 1 and 2, the LDH/AST ratio were low in both groups without significant difference. In the group with PN, thereafter, the LDH/AST ratio increased gradually, reached peak values at the 7th days and decreased. In the non-PN patients, the LDH/AST ratio increased gradually, but remained below the control range. The LDH/AST ratios were significantly higher from post-admission day 3 in the group with PN than in the non-PN group. In acute AP, the LDH levels were significantly higher over two weeks from admission day in the PN patients. The LDH/AST ratios were remained within or below the control range in both groups, though with statistically significnat difference. CONCLUSION: The LDH/AST ratio could be used as an indicator of PN in acute BP. In acute AP, however, LDH was a more useful indicator from the early stage in the course.
Alcoholics*
;
Humans
;
L-Lactate Dehydrogenase
;
Necrosis*
;
Pancreatitis, Alcoholic*
;
Plasma
;
Tomography, X-Ray Computed
6.A Case of Gastric Adenocarcinoma Appearing as Skin Metastasis.
Sea Hyub KAE ; Sang Aun JOO ; Jin LEE ; Sang Taek KWAK ; Seung Sik KANG ; Hyun Joo CHANG ; Won Jong PARK ; Jung Han KIM
Korean Journal of Gastrointestinal Endoscopy 1999;19(4):618-624
The skin is an uncommon site of distant metastasis from any internal malignancy, and the incidence of metastatic skin lesions as the first symptom of disease is only 0.8% in patients with all systemic malignancies. Furthermore, cutaneous metastasis from adenocarcinoma of the stomach has been found to be extremely rare. A 35-year-old female patient was admitted due to multiple cutaneous nodules in her chest, abdomen, and back. A gastroendoscopic examination and biopsy was made according to the results of skin pathologic findings. Stomach and skin biopsy results revealed a signet ring cell type of adenocarcinoma. A case of gastric adenocarcinoma in which metastatic skin nodules appeared as the first sign of disease, is here in reported with a review of related literature.
Abdomen
;
Adenocarcinoma*
;
Adult
;
Biopsy
;
Female
;
Humans
;
Incidence
;
Neoplasm Metastasis*
;
Skin*
;
Stomach
;
Stomach Neoplasms
;
Thorax
7.A Case of Choledochocolonic Fistula Combined with Absence of Gallbladder.
Jin LEE ; Sang Taek KWAK ; Yoo Sun CHUNG ; Seung Sik KANG ; Sun Hwa JUNG ; Hae Seang YIM ; Hyun Joo CHANG ; Sae Hyub KAE ; Sang Aun JOO ; Bong Hwa LEE
Korean Journal of Gastrointestinal Endoscopy 1999;19(3):481-485
The enterobiliary fistulas are mostly spontaneous and are caused by biliary disease associated with calculi. Review of many series shows that the most common variety of enterobiliary fistulas is a cholecystoduodenal fistula followed by cholecystocolic, cholecystogastric and choledochoduodenal fistula in that order. But very few cases of choledochocolonic fistulae have been reported. We report a case of choledocholithiasis combined with the absence of gallbladder leading to a choledochocolonic fistula, which was confirmed by endoscopic retrograde cholangiography and abdominal exploration in a 63- year-old male patient with complaint of right upper abdominal pain.
Abdominal Pain
;
Calculi
;
Cholangiography
;
Choledocholithiasis
;
Fistula*
;
Gallbladder*
;
Humans
;
Intestinal Fistula
;
Male
8.Clinical Significance of Low Junction of the Cystic Duct.
Sea Hyub KAE ; Sang Aun JOO ; Jin LEE ; Seung Sik KANG ; Seong Jin KIM ; Won Jong PARK ; Jung Han KIM ; Chang Uck KIM
Korean Journal of Gastrointestinal Endoscopy 1999;19(5):747-755
BACKGROUND AND AIMS: Recently, similar to the anomalous union of the pancreatobiliary duct (AUPBD), a low junction of the cystic duct (LJCD) was reported to be associated with the carcinogenesis of the gall bladder (GB) and other pancreatobiliary diseases. This study was designed to evaluate the clinical significance of the LJCD. METHODS: In this study all cases were performed ERCP. Three hundred and twenty two cases were selected due to their clear identification of the union area between the bile duct and the pancreatic duct, inserted area of the cystic duct, and the duodenal opening of the bile duct. The LJCD was defined that the cystic duct joins the distal bile duct between the upper margin of the pancreas and the duodenal opening of the bile duct. AUPBD was defined as a common channel greater than 15 mm in length. The clinical data was divided into four groups-normal biliary anatomy (Group 1), AUPBD (Group 2), LJCD (Group 3), and combined with AUPBD and LJCD (Group 4), and then analyzed. RESULTS: The mean age of the subjects was 56.6 with 183 male and 139 female cases. Among 322 cases, there were 7.1% (23 of 322) of AUPBD, 11.2% (36 of 322) of LJCD and 0.6% (2 of 322) of combined with AUPBD and LJCD. The clinical symptoms and the laboratory findings of the subjects were no statistical significance among the groups. The incidence of CBD stones was 27.3% (88 of 322) of the patients; 25.3% (66 of 261) of Group 1, 21.7% (5 of 23) of Group 2, 47.2% (17 of 36) of Group 3, and were significantly higher in Group 3 than Group 1 & Group 3 (p=0.038). However, the incidence of GB stones and cystic duct stones was no statistical significance among the groups. Malignant diseases of the biliary trees were 9.65% (31 of 322) of the patients; 6.8% (18 of 261) of Group 1, 26% (6 of 23) of Group 2, 13.8% (5 of 36) of Group 3, and were closely correlated with AUPBD (p<0.001) and LJCD (p=0.017). CONCLUSIONS: LJCD is relatively common in patients undergoing ERCP and closely correlated with the CBD stones and the malignacies of the biliary system. However its role in these condition is uncertain and needs to be further investigated.
Bile Ducts
;
Biliary Tract
;
Carcinogenesis
;
Cholangiopancreatography, Endoscopic Retrograde
;
Cystic Duct*
;
Female
;
Humans
;
Incidence
;
Male
;
Pancreas
;
Pancreatic Ducts
;
Urinary Bladder
9.Immunogenicity and Safety of Recombinant Hepatitis B Vaccine(Engerix B).
Kyung Ja LEE ; Min Kee CHO ; Woong Ki CHANG ; Hae Sun YOON ; Jae Kook CHA ; Jeong Eun CHOI ; Chong Young PARK ; Sang Aun JOO ; Hee Jung KANG
Korean Journal of Infectious Diseases 1998;30(1):69-74
BACKGROUND: Several studies on the efficacy and safety of the hepatitis B vaccine have shown variable immunogenicity. In this study we reexamined the immunogenicity and safety of recombinant hepatitis B vaccine, Engerix B which have currently been administered to the children in Korea. METHODS: Serum samples were collected from 126 children and 111 adults who were immunized according to the 0, 1, 2-month and 0, 1, 6-month vaccination schedule. Anti-HBs antibody titers were measured by ELISA in sera obtained after each immunization, and compared by immunization schedules. RESULTS: In 62 children with 0, 1, 2-month immunization schedule seroconversion rate was 83.9% after 1st vaccination, 96.8% after 2nd, and 98.4% after 3rd. In 64 children with 0, 1, 6-month immunization schedule seroconversion rates was 78.1% after 1st vaccination, 87.5% after 2nd and 100% after 3rd. In 50 adults immunized with 0, 1, 2-month schedule seroconversionrates was 48.0% after 1st vaccination, 74.0% after 2nd and 90.0% after 3rd. In 61 adults immunized with 0, 1, 6-month schedule seroconversion rate was 44.3% after 1st vaccination, 65.6% after 2nd and 93.4% after 3rd. Seroconversion rate after 0, 1, 2- month vaccination schedule were 98.4% in children and 90.0% in adults. Seroconversion rate after 0, 1, 6-month schedule were 100% in children and 93.4% in adults. There were no significant local and systemic untoward reactions among vaccinees. CONCLUSION: The recombinant Engerix B is excellent in immunogenicity with 93.4% and 100% seroconversion rates in adults and children, respectively. There is no significant difference in seroconversion rate between two vaccination schedule. The vaccine is safe.
Adult
;
Appointments and Schedules
;
Child
;
Enzyme-Linked Immunosorbent Assay
;
Hepatitis B Vaccines
;
Hepatitis B*
;
Hepatitis*
;
Humans
;
Immunization
;
Immunization Schedule
;
Korea
;
Vaccination
10.A Case of a Papillary Cystic Neoplasm of the Pancreas, Communicated by Main Pancreatic Duct.
Woo Jung PARK ; Yoo Sun CHUNG ; Son Hwa JUNG ; Chang Jae RHIM ; Kwun Soo KIM ; Seung Sik KANG ; Sea Hyub KAE ; Jin LEE ; Sang Taek KWAK ; Sang Aun JOO
Korean Journal of Gastrointestinal Endoscopy 1998;18(3):432-437
Papillary cystic neoplasms of the pancreas are uncommon. They occurs almost entirely in young women. Generally, the lesion averages 10 cm 17 size and are usually located in the pancreatic tail, resulting in displacement of the pancreatic duct. A varialbe amount of hemorrhage and liquefaction necrosis occurs, resulting in pseudopapillae cysts. Resection of the tumor is usually associated with a excellent prognosis because of the lack of metastases and rare recurrences. In this report present a case of a papillary cystic neoplasm of the pancreas with a review of references. Unlike most, the neoplasm we discovered was small (about 1.5 x 1.5 cm), and, occured in the pancreatic head of eldcrly woman. Moreover it was communicated by the main pancreatic duct via a side branch.
Female
;
Head
;
Hemorrhage
;
Humans
;
Necrosis
;
Neoplasm Metastasis
;
Pancreas*
;
Pancreatic Ducts*
;
Prognosis
;
Recurrence
Result Analysis
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