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.Is End Stage Renal Disease a Poor Prognosis Factor of Ischemic Colitis?.
Sung Eun AHN ; Hang Lak LEE ; Seung Chul CHO ; Jai Hoon YOON ; Oh Young LEE ; Byung Chul YOON ; Ho Soon CHOI ; Joon Soo HAHM ; Min Ho LEE ; Dong Hoo LEE
The Korean Journal of Gastroenterology 2009;53(4):235-238
BACKGROUND/AIMS: In general, ischemic colitis has a very good prognosis. However, there are a lot of controversies in relation to the prognostic factors. The aim of this study was to evaluate risk factors of severe ischemic colitis. METHODS: A retrospective study was undertaken of patients with ischemic colitis hospitalized at the Hanyang University Hospital during the interval 2004-2006. Patients were divided into two groups: those with mild course and those with severe course which led to operation, systemic inflammatory response syndrome, or death. RESULTS: A total of 41 cases (M/F=13/28, mean age=63.8 years) of biopsy proven ischemic colitis were included, of which 31 (75.6%) had a mild course and 10 (24.4%) a severe course. Coexisting medical diseases of patients were hypertension (n=24), diabetes (n=14), end-stage renal disease (n=11), cardiovascular disease (n=5), and malignancy (n=5). Male (p=0.049), alcoholics (p=0.025), end-stage renal disease (p=0.013), LDH (p=0.002), CRP (p=0.014), and peritoneal irritation sign (p=0.001) were the significant risk factors of severe ischemic colitis in univariate analysis. In multivariate logistic regression analysis, end-stage renal disease (p=0.026) was the only significant risk factor of severe ischemic colitis. CONCLUSIONS: Careful attention must be paid to end-stage renal disease patients having ischemic colitis.
Aged
;
Colitis, Ischemic/diagnosis/*etiology
;
Female
;
Humans
;
Kidney Failure, Chronic/*complications/diagnosis
;
Logistic Models
;
Male
;
Middle Aged
;
Multivariate Analysis
;
Predictive Value of Tests
;
Prognosis
;
Retrospective Studies
;
Risk Factors
;
Severity of Illness Index
3.Assessment of Autonomic Response before and after Total Spinal Anesthesia in Rats: Power Spectral Analysis.
Gyu Sam HWANG ; In Young HUH ; Su Jin KANG ; Mi Ok YOUN ; Won Jung SHIN ; Byung Moon CHOI ; Su Keoung LEE ; Seong Sik KANG ; Jeong Lak LEE ; Sung Kang CHO
Korean Journal of Anesthesiology 2005;48(2):182-189
BACKGROUND: Total spinal anesthesia (TSA) after injections of local anesthetics into the intrathecal space during epidural anesthesia is not rare. TSA anesthetizes cranial nerves and peripheral nerves, causes specific circulatory disturbances related to autonomic imbalance. Spectral analysis of heart rate variability (HRV) and blood pressure variability (BPV) provide a dynamic assessment of sympathetic and parasympathetic tone. Cross-spectral analysis has been used to emphasize this dynamic baroreflex control of HR as a frequency-dependent phenomenon and allows an assessment of baroreflex function. To examine the effects of TSA on the autonomic nervous system, we used spectral and cross-spectral analytic METHODS. METHODS: We investigated 14 rats before and after TSA. Power spectral densities of blood pressure (BP) and heart rate (HR) were estimated by fast Fourier transform. To evaluate the effect of TSA on baroreflex function, the cross spectral gain, phase, and coherence between beat-to-beat BP and HR signals were calculated by using transfer function analysis. RESULTS: With the onset of TSA, BP and HR significantly decreased. TSA significantly decreased the low frequency (LF) and high frequency (HF) components of HRV and BPV. Baroreflex sensitivity (BRS) obtained from transfer function gain between these variables was significantly decreased. CONCLUSIONS: TSA reduces the LF and HF components of HRV and BPV. These suggest that TSA in rats decreases both parasympathetic and sympathetic drive. Moreover, the decrease in BRS suggests impairment of cardiac baroreflex buffering function during TSA.
Anesthesia, Epidural
;
Anesthesia, Spinal*
;
Anesthetics, Local
;
Animals
;
Autonomic Nervous System
;
Baroreflex
;
Blood Pressure
;
Cranial Nerves
;
Fourier Analysis
;
Heart Rate
;
Peripheral Nerves
;
Rats*
4.Effects of Respiratory Rate on Cardiovascular Variability under General Anesthesia with Mechanical Ventilation.
In Young HUH ; Sung Kang CHO ; Sang Ho SHIN ; Su Jin KANG ; Mee Ok YOUN ; Jeong Lak LEE ; Gyu Sam HWANG
Korean Journal of Anesthesiology 2005;48(5):503-508
BACKGROUND: Although heart rate variability (HRV) and blood pressure variability (BPV) arise from many different influences, probably the most consistent external modulator is respiration. At rest, the heart rate increases on inspiration and decreases on expiration, a phenomenon called respiratory sinus arrhythmia (RSA). Spectral analysis of heart rate offers good and reproducible estimate of RSA and BPV. Many studies have been conducted on the effects of respiration on HRV and BPV during awake subject breathing spontaneously. However, little is known as to whether respiratory rate modulates HRV and BPV during general anesthesia with mechanical ventilation. Here, we studied effects of respiratory rate on HRV and BPV during general anesthesia. METHODS: We studied 40 patients undergoing general anesthesia with mechanical ventilation. Maintaining anesthesia with isoflurane, we recorded R-R interval and systolic blood pressure at respiratory rate of 15, 10 and 6 breaths/minute. Data was analyzed by the power spectral analyses of HRV and BPV, which were divided into low frequency (LF) and high frequency (HF) band. RESULTS: Respiratory rate did not affect RR interval, systolic blood pressure, and total spectral power HRV and BPV. Compared with its value at 15 breaths/minute, HF-HRV was significantly increased at 6 breaths/minute. HF-and LF-BPV at 6 breaths/minute were significantly increased versus 15 breaths/minute. CONCLUSIONS: Respiratory rate modulates HRV and BPV during general anesthesia with mechanical ventilation. We suggest that respiratory rate should be considered and controlled in studies of cardiovascular variability during general anesthesia.
Anesthesia
;
Anesthesia, General*
;
Arrhythmia, Sinus
;
Blood Pressure
;
Heart Rate
;
Humans
;
Isoflurane
;
Respiration
;
Respiration, Artificial*
;
Respiratory Rate*
5.The Endoscopic Findings and Clinical Characteristics of Gastrointestinal Amyloidosis.
Won MOON ; Oh Young LEE ; Yun Ju CHO ; Sun Young YANG ; Ho Yong PARK ; Sung Hee HAN ; Hang Lak LEE ; Byoeng Chul YOON ; Ho Soon CHOI ; Joon Soo HAHM ; Min Ho LEE ; Dong Hoo LEE ; Choon Suhk KEE
Korean Journal of Gastrointestinal Endoscopy 2005;31(4):216-220
BACKGROUND/AIMS: Gastrointestinal involvement is common in systemic amyloidosis. However, there have not been reports of any specific endoscopic findings which indicate amyloidosis in the gastrointestinal tracts in Korea. We aimed to find out the endoscopic findings and clinical characteristics of gastrointestinal amyloidosis. METHODS: We analyzed seventeen histologic proven amyloidosis cases that all performed the endoscopy in Hanyang Medical Cencer. RESULTS: The main findings of gastroscopy were multiple erosions (5 cases), ulcer (3 cases), nodularities and hyperemic mucosa (1 case). Colonoscopic findings were hyperemic mucosa (8 cases), nodularities (3 cases), hemorrhagic spots (3 cases) and ulcers (3 cases). CONCLUSIONS: When a patient undergoing chronic inflammatory diseases has various abdominal symptoms, endoscopic biopsy should be done in every case because grossly normal looking mucosa dose not preclude the histologic evidence of amyloidosis.
Amyloidosis*
;
Biopsy
;
Endoscopy
;
Gastrointestinal Tract
;
Gastroscopy
;
Humans
;
Korea
;
Mucous Membrane
;
Ulcer
6.Clinical Manifestation and Associated Cardiac Anomalies of Dextrocardia.
Sung Hoon KIM ; Seung A HONG ; Yoon Jung CHO ; Sang Lak LEE ; Tae Chan KWON
Journal of the Korean Pediatric Society 2002;45(5):622-628
PURPOSE: The purpose of this study is to ascertain the clinical manifestations and associated cardiac anomalies of dextrocardia. METHODS: Twenty-four pediatric patients, who were admitted to, or visited, Dongsan Medical Center Keimyung University and were diagnosed with dextrocardia between January 1996 and July 2001, were enrolled in this study. All patients received echocardiogram and abdominal ultrasonogram to identify structural cardiac anomalies and visceral position. RESULTS:Among 24 patients, 7 cases were situs solitus(29.2%), 10 cases(41.6%) were situs inversus and 7 cases(29.2%) were situs ambiguous. Most were diagnosed within a week of life(87.5%). They were most commonly cyanotic(45.8%), but eleven cases(45.8%) had no specific symptoms or signs. Nineteen cases(79.2%) had accompanied cardiac anomalies, and pulmonary stenosis or atresia were the most common among them. All the cases of situs solitus and ambiguous had associated cardiac anomalies, but half of the situs inversus had that. Eleven cases were dead by cardiac or extracardiac anomalies during follow up and the mortality rate was higher in situs solitus or ambiguous group than situs inversus group. CONCLUSION: Dextrocardia accompanies different cardiac and extracardiac anomalies. It's very important to diagnose dextrocardia and associated cardiac or extracardiac anomalies in the early stages of life to improve prognosis.
Dextrocardia*
;
Follow-Up Studies
;
Humans
;
Mortality
;
Prognosis
;
Pulmonary Valve Stenosis
;
Situs Inversus
;
Ultrasonography
7.Four Cases of Management of Congenital Coronary Arteriovenous Fistula.
Sook Jin LEE ; Sahng LEE ; Kyung Soo KIM ; Han Pyo CHO ; Dae Hee SHIN ; Sung Il CHOI ; Hang Lak LEE ; Jae Ung LEE ; Soon Gil KIM ; Jeong Hyun KIM ; Heon Kil LIM ; Bang Hun LEE ; Chung Kyun LEE
Korean Circulation Journal 2002;32(2):163-169
Four cases of congenital coronary arteriovenous fistula were diagnosed using coronary angiography. Three cases had fistula-related chest pain and the remaining case showed no symptoms but displayed electrocardiographic changes suggesting myocardial ischemia. As he was elderly and had a potential for future complications, we decided to close the fistulas of all cases. Three cases were closed with transcatheter coil embolization and one with surgical ligation due to a suspicious accompanying pericardial cyst. None of the patients demonstrated periprocedural or perioperative complications and all were relieved from symptoms during the 2 year follow-up period. We concluded that transcatheter coil embolization and surgical ligation are effective methods for use in the management of coronary arteriovenous fistula.
Aged
;
Arteriovenous Fistula*
;
Chest Pain
;
Coronary Angiography
;
Coronary Disease
;
Electrocardiography
;
Embolization, Therapeutic
;
Fistula
;
Follow-Up Studies
;
Humans
;
Ligation
;
Mediastinal Cyst
;
Myocardial Ischemia
8.A Neonatal Case of Symptomatic Congenital Cytomegalovirus Infection with Hearing Defect.
Sung Jun JANG ; Yoon Jung CHO ; Sang Lak LEE ; Joon Sik KIM ; Tae Chan KWON
Journal of the Korean Pediatric Society 2001;44(2):205-210
Cytomegalovirus(CMV) is one of the leading cause of intrauterine infections of man with an incidence ranging from 0.48% to 2.2% of all live births. Although the majority of CMV-infected newborns are clinically asymptomatic at birth, some will have signs of congenital infection : Intrauterine growth retardation, petechial or purpuric rash, microcephaly, anemia, thrombocytopenia, jaundice, hepatosplenomegaly and intracranial calcification. We experienced a case of symptomatic congenital CMV infection in a 1-day-old male who presented generalized petechiae, hepatosplenomegaly, anemia, thrombocytopenia. Urine PCR and viral culture for CMV were positive, and a brain CT revealed ventriculomegaly and periventricular calcification. And auditory evoked potential revealed left sensorineural hearing loss. He received ganciclovir treatment for 6 weeks, was discharged in good health, and continued conunder follow-up at the outpatient department.
Anemia
;
Brain
;
Cytomegalovirus Infections*
;
Cytomegalovirus*
;
Evoked Potentials, Auditory
;
Exanthema
;
Fetal Growth Retardation
;
Follow-Up Studies
;
Ganciclovir
;
Hearing Loss
;
Hearing Loss, Sensorineural
;
Hearing*
;
Humans
;
Incidence
;
Infant, Newborn
;
Jaundice
;
Live Birth
;
Male
;
Microcephaly
;
Outpatients
;
Parturition
;
Polymerase Chain Reaction
;
Purpura
;
Thrombocytopenia
9.The Long Term Outcome of Percutaneous Endoscopic Discectomy.
Gi Hyune KIM ; Sung Lak LEE ; Jae Hoon CHO ; Dong Gee KANG ; Sang Chul KIM
Journal of Korean Neurosurgical Society 2001;30(2):150-155
Between January 1995 and May 1998, 177 patients with proven lumbar disc herniation were treated by microdiscectomy or by percutaneous endoscopic discectomy(PED). Among them, 43(24.2%) patients underwent PED and were followed for long term outcome. We included only those patients who were followed up more than 13 months. Three patients who did not improved immediately after PED and underwent microdiscectomy were excluded for this study. Of remaining 40 patients, there were 22 men and 18 women who ranged in age from 23 to 68 years (mean 38.1 years). The disc herniations were located at L1-2(1), L2-3(1), L3-4(1), L4-5(26) and L5-S1(11). Three patients were treated by biportal approach. The mean follow up period was 34.7 months(range 13-47 months). Overall, excellent and good results were achieved in 12(30%) and 19(47.5%) patients, and fair and poor results in 7(17.5%) and 2(5%) patients, respectively. Thirty-eight(95%) patients returned to their previous works and the mean duration was 5.7 months. Thirty-three(82.5%) patients answered that they would recommend this procedure to others. There was no complication except for one patient who suffered from discitis. The indication of PED is restricted to contained or small subligamentous lumbar disc herniation without stenosis, spondylolisthesis and sequestration. PED can be performed under local anesthesia and tissue trauma, risk of epidural scarring, hospitalization time and postoperative morbidity are minimal. The result of the present study justify the assumption that PED can be a surgical alternative for patients suitable for its indications.
Anesthesia, Local
;
Cicatrix
;
Constriction, Pathologic
;
Discitis
;
Diskectomy*
;
Female
;
Follow-Up Studies
;
Hospitalization
;
Humans
;
Male
;
Spondylolisthesis
10.Orbital Cavernous Lymphangioma with Intracranial Extension: Case Report.
Gi Hyune KIM ; Sung Lak LEE ; Jae Hoon CHO ; Dong Gee KANG ; Sang Chul KIM
Journal of Korean Neurosurgical Society 2001;30(1):105-109
Lymphangioma is a rare benign developmental vascular tumor that may be found in orbit, skull and elsewhere in head and neck. Few cases of extension of this benign but insidious tumor posteriorly out of the bony orbital cavity have been reported. The patient was 40-year-old man complaining of proptosis of right eye for one month. Physical examination revealed severe right exophthalmus, impairment of eyeball movement in all directions. Visual acuity was much impaired and he could percept only light with right eye. CT and MRI scans showed intraconal and extraconal involvement of ill-defined, heterogenous mass with extension of the tumor posteriorly beyond the orbital cavity involving right frontal and temporal lobe, skull and subcutaneous tissue. The tumor was subtotally removed via orbito-frontal approach without damaging vital neural and orbital component. Then, orbital roof reconstruction and cranioplasty were done with resin. Successful surgical removal of lymphangioma is very difficult due to its severe infiltration to surrounding tissue and tendency to bleed during debulking. We report a rare case of orbital cavernous lymphangioma with intracranial extension treated with surgical decompression, with review of literatures.
Adult
;
Decompression, Surgical
;
Exophthalmos
;
Head
;
Humans
;
Lymphangioma*
;
Magnetic Resonance Imaging
;
Neck
;
Orbit*
;
Physical Examination
;
Skull
;
Subcutaneous Tissue
;
Temporal Lobe
;
Visual Acuity

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