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.Relationship between 15-hydroxyprostaglandin dehydrogenase and gastric adenocarcinoma.
Jae Hyun KANG ; Sang Hyun KANG ; Sang Hyuk SEO ; Jae Ho SHIN ; Min Sung AN ; Tae Kwun HA ; Ki Beom BAE ; Tae Hyun KIM ; Chang Soo CHOI ; Sang Hoon OH ; Mi Seon KANG ; Kwang Hee KIM
Annals of Surgical Treatment and Research 2014;86(6):302-308
PURPOSE: Prostaglandin E2 (PGE2) is a contributory carcinogen in gastric adenocarcinoma. 15-Hydroxyprostaglandin dehydrogenase (15-PGDH) catabolizes PGE2 by oxidizing its 15(s)-hydroxy group. The aim of this study was to investigate the expression of 15-PGDH in gastric adenocarcinoma tissue and the relationship between 15-PGDH expression and clinicopathologic features of gastric adenocarcinoma. METHODS: Ninety-nine patients who underwent surgical resection for gastric adenocarcinoma between January 2007 and December 2007 were enrolled and evaluated retrospectively. RESULTS: In 62 patients (62.6%), 15-PGDH expression was lower in gastric adenocarcinoma tissue than in nonneoplastic tissue. Regarding the relationship between 15-PGDH expression and clinicopathological features, 15-PGDH expression was significantly lower in tissues with poor differentiation (P = 0.002), advanced T stage (P = 0.0319), a higher number of lymph node metastases (P = 0.045), lymphatic invasion (P = 0.031), and vascular invasion (P = 0.036). CONCLUSION: 15-PGDH expression was associated with a subset of clinicopathologic features such as differentiation grade, T stage, lymphatic invasion, and vascular invasion.
Adenocarcinoma*
;
Dinoprostone
;
Humans
;
Lymph Nodes
;
Neoplasm Metastasis
;
Oxidoreductases*
;
Retrospective Studies
;
Stomach Neoplasms
3.Association Between a Close Distal Resection Margin and Recurrence After a Sphincter-Saving Resection for T3 Mid- or Low-Rectal Cancer Without Radiotherapy.
Jae Woong HAN ; Min Jae LEE ; Ha Kyung PARK ; Jae Ho SHIN ; Min Sung AN ; Tae Kwun HA ; Kwang Hee KIM ; Ki Beom BAE ; Tae Hyun KIM ; Chang Soo CHOI ; Sang Hoon OH ; Min Kyung OH ; Mi Seon KANG ; Kwan Hee HONG
Annals of Coloproctology 2013;29(6):231-237
PURPOSE: To maintain the patient's quality of life, surgeons strive to preserve the sphincter during rectal cancer surgery. This study evaluated the oncologic safety of a sphincter-saving resection with a distal resection margin (DRM) <1 cm without radiotherapy in T3, mid- or low-rectal cancer. METHODS: This retrospective study enrolled 327 patients who underwent a sphincter-saving resection for proven T3 rectal cancer located <10 cm from the anal verge and without radiotherapy between January 1995 and December 2011. The oncologic outcomes included the 5-year cancer-specific survival, the local recurrence, and the systemic recurrence rates. RESULTS: In groups A (DRM < or =1 cm) and B (DRM >1 cm), the 5-year cancer-specific survival rates were 81.57% and 80.03% (P = 0.8543), the 5-year local recurrence rates were 6.69% and 9.52% (P = 0.3981), and the 5-year systemic recurrence rates were 19.46% and 23.11% (P = 0.5750), respectively. CONCLUSION: This study showed that the close DRM itself should not be a contraindication for a sphincter-saving resection for T3 mid- or low-rectal cancer without radiotherapy. However, a prospective randomized controlled trial including the effect of adjuvant therapy will be needed.
Humans
;
Quality of Life
;
Radiotherapy*
;
Rectal Neoplasms
;
Recurrence*
;
Retrospective Studies
;
Survival Rate
4.Prognostic Significance of the Decreased Rate of Perioperative Serum Carcinoembryonic Antigen Level in the Patients With Colon Cancer After a Curative Resection.
Tae Doo JUNG ; Jong Han YOO ; Min Jae LEE ; Ha Kyung PARK ; Jae Ho SHIN ; Min Sung AN ; Tae Kwun HA ; Kwang Hee KIM ; Ki Beom BAE ; Tae Hyeon KIM ; Chang Soo CHOI ; Min Kyung OH ; Kwan Hee HONG
Annals of Coloproctology 2013;29(3):115-122
PURPOSE: The serum level of carcinoembryonic antigen (CEA) is a clinical prognostic factor in the follow-up evaluation of patients with colon cancer. We aimed to evaluate the prognostic significance of the rate of decrease of the perioperative serum CEA level in patients with colon cancer after a curative resection. METHODS: A total of 605 patients who underwent a curative resection for colon cancer between January 2000 and December 2007 were enrolled retrospectively. The rate of decrease was calculated using the following equation: ([preoperative CEA - postoperative CEA]/[preoperative CEA] x100). RESULTS: In the group with a preoperative serum CEA level of >5 ng/mL, the normalized group with a postoperative serum CEA level of < or =5 ng/mL showed a better overall survival (OS) rate and disease-free survival (DFS) rate than those of the non-normalized group (P < or = 0.0001). The "cutoff values" of the rate of decrease in the perioperative serum CEA that determined the OS and the DFS were 48.9% and 50.8%, respectively. In the multivariate analysis of preoperative serum CEA levels >5 ng/mL, the prognostic factors for the OS and the DFS were the cutoff value (P < 0.0001) and the pN stage (P < 0.0001). CONCLUSION: A rate of decrease of more than 50% in the perioperative serum CEA level, as well as the normalization of the postoperative serum CEA level, may be useful factors for determining a prognosis for colon cancer patients with high preoperative CEA levels.
Carcinoembryonic Antigen
;
Colon
;
Colonic Neoplasms
;
Disease-Free Survival
;
Follow-Up Studies
;
Humans
;
Multivariate Analysis
;
Prognosis
;
Retrospective Studies
5.Prognostic Significance of the Decreased Rate of Perioperative Serum Carcinoembryonic Antigen Level in the Patients With Colon Cancer After a Curative Resection.
Tae Doo JUNG ; Jong Han YOO ; Min Jae LEE ; Ha Kyung PARK ; Jae Ho SHIN ; Min Sung AN ; Tae Kwun HA ; Kwang Hee KIM ; Ki Beom BAE ; Tae Hyeon KIM ; Chang Soo CHOI ; Min Kyung OH ; Kwan Hee HONG
Annals of Coloproctology 2013;29(3):115-122
PURPOSE: The serum level of carcinoembryonic antigen (CEA) is a clinical prognostic factor in the follow-up evaluation of patients with colon cancer. We aimed to evaluate the prognostic significance of the rate of decrease of the perioperative serum CEA level in patients with colon cancer after a curative resection. METHODS: A total of 605 patients who underwent a curative resection for colon cancer between January 2000 and December 2007 were enrolled retrospectively. The rate of decrease was calculated using the following equation: ([preoperative CEA - postoperative CEA]/[preoperative CEA] x100). RESULTS: In the group with a preoperative serum CEA level of >5 ng/mL, the normalized group with a postoperative serum CEA level of < or =5 ng/mL showed a better overall survival (OS) rate and disease-free survival (DFS) rate than those of the non-normalized group (P < or = 0.0001). The "cutoff values" of the rate of decrease in the perioperative serum CEA that determined the OS and the DFS were 48.9% and 50.8%, respectively. In the multivariate analysis of preoperative serum CEA levels >5 ng/mL, the prognostic factors for the OS and the DFS were the cutoff value (P < 0.0001) and the pN stage (P < 0.0001). CONCLUSION: A rate of decrease of more than 50% in the perioperative serum CEA level, as well as the normalization of the postoperative serum CEA level, may be useful factors for determining a prognosis for colon cancer patients with high preoperative CEA levels.
Carcinoembryonic Antigen
;
Colon
;
Colonic Neoplasms
;
Disease-Free Survival
;
Follow-Up Studies
;
Humans
;
Multivariate Analysis
;
Prognosis
;
Retrospective Studies
6.Analysis of Clinical Outcome and Complications After Microsurgical Clipping of Unruptured Paraclinoid Aneurysms.
Sun Kyu OH ; In Seok JANG ; Jae Sung AHN ; Do Hoon KWON ; Byung Duk KWUN
Korean Journal of Cerebrovascular Surgery 2010;12(3):202-205
OBJECTIVE: The study reports the clinical outcomes and complication rates of microsurgical clipping of unruptured paraclinoid aneurysms. METHODS: From July 1997 to December 2008, 61 patients underwent microsurgical clipping for 61 unruptured paraclinoid aneurysms in our institute. Entire medical records, radiographic data, and operation records were reviewed retrospectively. RESULTS: After the microsurgical clipping, complete obstruction was achieved in 56 patients (91.8%). Visual disturbance (nine cases, 14.8%) was the most frequent complication. Overall, 59 patients (96.7%) had a good long-term outcome (Glasgow outcome scale score of 4-5 3 months post-operatively). CONCLUSION: For patients with paraclinoid aneurysms, satisfactory outcomes can be achieved by microneurosurgical management. These results will be useful when considering treatment of an unruptured paraclinoid aneurysm.
Aneurysm
;
Humans
;
Medical Records
7.The Experience of the 1st Daegu-Gyeongbuk Multicenter Epilepsy Camp for Children and their Parents to improve the understanding of Epilepsy.
Sung Min CHO ; Soon Hak KWON ; Doo Kwun KIM ; Jun Sik KIM ; Jin Kyung KIM ; Han Koo MOON ; Woo Saeng PARK ; Ji Hyun YEO ; Hyun Hee OH ; Eun Ju LEE ; Jun Hwa LEE ; Bo Young KIM
Journal of the Korean Child Neurology Society 2006;14(2):303-309
PURPOSE:This study was undertaken to announce our experience of the 1st Daegu- Gyeongbuk Multicenter Epilepsy Camp for children and their parents to improve the understanding of epilepsy. METHODS:We held the camp on February 25th to 26th, 2006 at Gyeongju. 33 families with epileptic childlend joined the camp. At the end of the camp, we performed a survey with 37 questionnaires to obtain data concerning the parents' understanding of epilepsy and the satisfaction with the camp. Data was analyzed with SPSS 10.0 program using frequency analysis. RESULTS:Parents knew about epilepsy but for some degrel still wanted to get more information about epilepsy. Parents were satisfied with the educational programs but not with the recreation programs. CONCLUSION:This study suggests that more social approaches such as an epilepsy camp is needed to provide the families with more information fot the understanding about epilepsy.
Child*
;
Epilepsy*
;
Gyeongsangbuk-do
;
Humans
;
Parents*
;
Surveys and Questionnaires
;
Recreation
8.Buerger's Disease in Korea.
Jang Sang PARK ; Geun Eun KIM ; Seong Ki MIN ; Sun cheol PARK ; In Sung MOON ; Sung HEO ; Ho Chul PARK ; Won Hyun JO ; Hyung Tae KIM ; Do Kyun KIM ; Jong Kwon PARK ; Ki Hyuk PARK ; Jeong An LEE ; Joong Ki JUNG ; Sang Joon KIM ; Jong Won HA ; Young Wook KIM ; Dong Ik KIM ; Yong Sin KIM ; Seok Yul LEE ; Koing Bo KWUN ; Bo Yang SEO ; Tae Won KWON ; Hong Rae JO ; Byung Jun SO ; Hee Jae JUN ; Sang Yeong JUNG ; Oh Jeong KWON ; Hyun Chul KIM
Journal of the Korean Society for Vascular Surgery 2005;21(2):105-112
PURPOSE: Buerger's disease (Thromboangiitis obliterans, TAO) is characterized by non- atheromatous inflammatory disease, and segmental inflammatory thrombotic occlusions of the small & middle-sized arteries and veins of the upper or lower extremities. Any epidemiological study of Buerger's disease in Korea has not been carried out until now. This study was undertaken to investigate the incidence of Buerger's disease in Korea among the patients suffering with arterial disease. METHODS: We collected and analyzed the data on 11,128 patients who were admitted to or visited the participating 22 hospitals for chronic arterial diseases throughout the major region of the South Korea from January 1986 to December 2003. The clinical diagnostic inclusion criteria for Buerger's disease were the followings: (1) a history of smoking or tobacco abuse; (2) an age of onset less than 50 years; (3) infrapopliteal, segmental arterial occlusions with sparing of the proximal vasculature; (4) frequent distal upper extremity arterial involvement (Raynaud's syndrome or digital ulceration) or-superficial phlebitis; and (5) the absence of arteriosclerotic risk factors other than smoking. RESULTS: The incidence rate of Buerger's disease among the arterial disease (11,128 patients) was 93 patients (0.83%) when the strict criteria of Shionoya was applied. 699 male-patients (6.55%) and 30 female patients (4.12%) who met the less strict criteria (the extended clinical diagnostic criteria group) were also reviewed. The 4th and 5th decades were the most common ages with-249 patients (34.2%) and 222 patients (30.5%) respectively, being found at these ages. The mean age was 40.4+/-1.6 years (age range: 16~83 years) and this was similar in both the strict criteria group and the less strict criteria group. CONCLUSIONS: This study suggests there was a low incidence of Buerger's disease in Korea among the patients who visited the participating hospitals when the strict diagnostic criteria were used. The incidence was lower than expected even when the less strict criteria were used. The more accurate incidence of Buerger's disease among the general population can be obtained by performing careful prospective study that is participated in by not only vascular surgeons, but also the other medical specialists with utilizing the strict diagnostic criteria.
Age of Onset
;
Arteries
;
Epidemiologic Studies
;
Female
;
Humans
;
Incidence
;
Korea*
;
Lower Extremity
;
Phlebitis
;
Risk Factors
;
Smoke
;
Smoking
;
Specialization
;
Thromboangiitis Obliterans*
;
Tobacco
;
Upper Extremity
;
Veins
9.Effects of Therapeutic Electrical Stimulation of Sensory Dermatome on Spasticity in Patients with Brain Lesion.
Yong Wook KIM ; Young Hee LEE ; Sung Hoon KIM ; Jeong Mee PARK ; Oh Yun KWUN
Journal of the Korean Academy of Rehabilitation Medicine 2003;27(1):27-32
OBJECTIVE: The purpose of this study was to investigate the immediate and delayed effects of electrical stimulation of sensory nerve pathway on spasticity in patients with brain lesions. METHOD: Sixteen stroke and traumatic brain injured subjects participated in this study. Electrical stimulation on the der matome of spastic muscles was applied for 30 minutes a day for 4 weeks. Spasticity was quantified through the use of a relaxation index obtained from pendulum test and a amplitude and latency from knee tendon reflex test. The measurements were performed 6 times in treatment period. The data were analyzed by repeated measures one way ANOVA. RESULTS: Relaxation index was significantly increased in treatment period (p<0.05). In each therapeutic stimulation session, relaxation index of post-stimulation was increased in comparison with that of pre-stimulation (p<0.01). The amplitude of post-stimulation was significantly decreased in comparison with pre-stimulation status in each measurement session (p<0.01). The latency of tendon reflex was not changed after stimulation. CONCLUSION: These results showed that the electrical stimulation was useful method to decrease spasticity in patients with brain lesions. Further studies are needed to explore the effects of functional improvement and the long-lasting carry over effects on spasticity in electrical stimulation.
Brain*
;
Electric Stimulation
;
Electric Stimulation Therapy*
;
Humans
;
Knee
;
Muscle Spasticity*
;
Muscles
;
Reflex, Stretch
;
Relaxation
;
Stroke
10.Barrier Techniques for Spinal Cord Protection from Thermal Injury in Polymethylmethacrylate Reconstruction of Vertebral Body:Experimental and Theoretical Analyses.
Choon Keun PARK ; Chul JI ; Jang Hoe HWANG ; Sung Oh KWUN ; Jae Hoon SUNG ; Seung Jin CHOI ; Sang Won LEE ; Sung Chan PARK ; Kyeung Suok CHO ; Chun Kun PARK ; Han Sen YUAN ; Joon Ki KANG
Journal of Korean Neurosurgical Society 2001;30(3):272-277
OBJECTIVES: Polymethylmethacrylate(PMMA) is often used to reconstruct the spine after total corpectomy, but the exothermic curing of liquid PMMA poses a risk of thermal injury to the spinal cord. The purposes of this study are to analyze the heat blocking effect of pre-polymerized PMMA sheet in the corpectomy model and to establish the minimal thickness of PMMA sheet to protect the spinal cord from the thermal injury during PMMA cementation of vertebral body. MATERIALS AND METHODS: An experimental fixture was fabricated with dimensions similar to those of a T12 corpectomy defect. Sixty milliliters of liquid PMMA were poured into the fixture, and temperature recordings were obtained at the center of the curing PMMA mass and on the undersurface(representing the spinal cord surface) of a pre-polymerized PMMA sheet of variable thickness(group 1:0mm, group 2:5mm, or group 3:8mm). Six replicates were tested for each barrier thickness group. RESULTS: Consistent temperatures(106.8+/-3.9degreesC) at center of the curing PMMA mass in eighteen experiments confirmed the reproducibility of the experimental fixture. Peak temperatures on the spinal cord surface were 47.3degreesC in group 2, and 43.3degreesC in group 3, compared with 60.0degreesC in group 1(p<0.00005). So pre-polymerized PMMA provided statistically significant protection from heat transfer. The difference of peak temperature between theoretical and experimental value was less than 1%, while the predicted time was within 35% of experimental values. The data from the theoretical model indicate that a 10mm barrier of PMMA should protect the spinal cord from temperatures greater than 39degreesC(the threshold for thermal injury in the spinal cord). CONCLUSION: These results suggest that pre-polymerized PMMA sheet of 10mm thickness may protect the spinal cord from the thermal injury during PMMA reconstruction of vertebral body.
Cementation
;
Hot Temperature
;
Models, Theoretical
;
Polymethyl Methacrylate*
;
Spinal Cord*
;
Spine

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