1.Efficacy and Safety of DWJ1252 Compared With Gasmotin in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study
Jin Hwa PARK ; Kang Nyeong LEE ; Oh Young LEE ; Myung-Gyu CHOI ; Hyunsoo CHUNG ; Suck-Chei CHOI ; Nayoung KIM ; Hyojin PARK ; In-Kyung SUNG ; Chong Il SOHN ; Sam Ryong JEE ; Jae Young JANG ; Poong-Lyul RHEE ; Moo In PARK ; Joong Goo KWON ; Kyung Sik PARK ; Kwang Jae LEE ; Joon Seong LEE
Journal of Neurogastroenterology and Motility 2021;27(1):87-96
Background/Aims:
Prokinetics such as mosapride citrate CR (conventional-release; Gasmotin) are commonly used in functional dyspepsia (FD). This study aims to evaluate the efficacy and safety of once-a-day mosapride citrate SR (DWJ1252), a sustained-release formulation of mosapride citrate, compared with mosapride citrate CR 3 times a day, in patients with FD.
Methods:
In this multicenter, randomized, double-blind, active-controlled, non-inferiority study, 119 patients with FD (by the Rome III criteria, 60 for mosapride citrate SR and 59 for mosapride citrate CR) were randomly allocated to mosapride citrate SR once daily or mosapride citrate CR thrice daily for 4 weeks in 16 medical institutions. Primary end point was the change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale after 4-week treatment. Secondary end points and safety profiles were also analyzed.
Results:
The study included 51 and 49 subjects in the mosapride citrate SR and mosapride citrate CR groups, respectively. GIS scores at week 4 were significantly reduced in both groups (mean ± SD: − 10.04 ± 4.45 and − 10.86 ± 5.53 in the mosapride citrate SR and mosapride citrate CR groups, respectively; P < 0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, − 1.17, 2.81; P = 0.643). Changes in GIS at weeks 2 and 4 and quality of life at week 4, and the improvement rates of global assessments at weeks 2 and 4, did not differ between the groups. Adverse events were similar in the 2 groups, and there were no serious adverse events.
Conclusion
In patients with FD, mosapride citrate SR once daily is as effective as mosapride citrate CR thrice daily, with a similar safety profile.
2.Robotic Cholecystectomy Using the Newly Developed Korean Robotic Surgical System, Revo-i: A Preclinical Experiment in a Porcine Model.
Chang Moo KANG ; Jae Uk CHONG ; Jin Hong LIM ; Dong Won PARK ; Sung Jun PARK ; Suhyeon GIM ; Hye Jin YE ; Se Hoon KIM ; Woo Jung LEE
Yonsei Medical Journal 2017;58(5):1075-1077
One Korean company recently successfully produced a robotic surgical system prototype called Revo-i (MSR-5000). We, therefore, conducted a preclinical study for robotic cholecystectomy using Revo-i, and this is a report of the first case of robotic cholecystectomy performed using the Revo-i system in a preclinical porcine model. Revo-i consists of a surgeon console (MSRC-5000), operation cart (MSRO-5000) and vision cart (MSRV-5000), and a 40 kg-healthy female porcine was prepared for robotic cholecystectomy with general anesthesia. The primary end point was the safe completion of these procedures using Revo-i: The total operation time was 88 minutes. The dissection time was defined as the time from the initial dissection of the Calot area to the time to complete gallbladder detachment from the liver bed: The dissection time required 14 minutes. The surgical console time was 45 minutes. There was no gallbladder perforation or significant bleeding noted during the procedure. The porcine survived for two weeks postoperatively without any complications. Like the da Vinci surgical system, the Revo-i provides a three-dimensional operative view and allows for angulated instrument motion (forceps, needle-holders, clip-appliers, scissors, bipolar energy, and hook monopolar energy), facilitating an effective laparoscopic procedure. Our experience suggests that robotic cholecystectomy can be safely completed in a porcine model using Revo-i.
Anesthesia, General
;
Cholecystectomy*
;
Device Approval
;
Female
;
Gallbladder
;
Hemorrhage
;
Humans
;
Liver
;
Robotic Surgical Procedures
3.Efficacy and Safety of Tiropramide in the Treatment of Patients With Irritable Bowel Syndrome: A Multicenter, Randomized, Double-blind, Non-inferiority Trial, Compared With Octylonium.
Kang Nyeong LEE ; Oh Young LEE ; Myung Gyu CHOI ; Chong Il SOHN ; Kyu Chan HUH ; Kyung Sik PARK ; Joong Goo KWON ; Nayoung KIM ; Poong Lyul RHEE ; Seung Jae MYUNG ; Joon Seong LEE ; Kwang Jae LEE ; Hyojin PARK ; Yong Chan LEE ; Suck Chei CHOI ; Hye Kyung JUNG ; Sam Ryong JEE ; Chang Hwan CHOI ; Gwang Ha KIM ; Moo In PARK ; In Kyung SUNG
Journal of Neurogastroenterology and Motility 2014;20(1):113-121
BACKGROUND/AIMS: Antispasmodics such as octylonium are widely used to manage irritable bowel syndrome (IBS) symptoms. However, the efficacy and safety of another antispasmodic, tiropramide, remain uncertain. We aimed to evaluate the efficacy and safety of tiropramide compared with octylonium in patients with IBS. METHODS: In this multicenter, randomized, non-inferiority trial, 287 patients with IBS (143 receiving tiropramide and 144 octylonium) were randomly allocated to either tiropramide 100 mg or octylonium 20 mg t.i.d (means 3 times a day) for 4 weeks. Primary endpoint was the mean change of abdominal pain from baseline assessed by visual analogue scales (VAS) score after 4 weeks of treatment. Secondary endpoints were the changes in abdominal pain from baseline at week 2 and in abdominal discomfort at weeks 2 and 4, using VAS scores, patient-reported symptom improvement including stool frequency and consistency, using symptom diaries, IBS-quality of life (IBS-QoL), and depression and anxiety, at week 4. RESULTS: The VAS scores of abdominal pain at week 4, were significantly decreased in both tiropramide and octylonium groups, but the change from baseline did not differ between the 2 groups (difference,-0.26 mm; 95% CI,-4.33-3.82; P = 0.901). Abdominal pain and discomfort assessed using VAS scores, diaries, and IBS-QoL were also improved by both treatments, and the changes from baseline did not differ. The incidence of adverse events was similar in the 2 groups, and no severe adverse events involving either drug were observed. CONCLUSIONS: Tiropramide is as effective as octylonium in managing abdominal pain in IBS, with a similar safety profile.
Abdominal Pain
;
Anxiety
;
Depression
;
Humans
;
Incidence
;
Irritable Bowel Syndrome*
;
Parasympatholytics
;
Weights and Measures
4.Prevalence of Primary Immunodeficiency in Korea.
Jung Woo RHIM ; Kyung Hyo KIM ; Dong Soo KIM ; Bong Seong KIM ; Jung Soo KIM ; Chang Hwi KIM ; Hwang Min KIM ; Hee Ju PARK ; Ki Soo PAI ; Byong Kwan SON ; Kyung Sue SHIN ; Moo Young OH ; Young Jong WOO ; Young YOO ; Kun Soo LEE ; Kyung Yil LEE ; Chong Guk LEE ; Joon Sung LEE ; Eun Hee CHUNG ; Eun Hwa CHOI ; Youn Soo HAHN ; Hyun Young PARK ; Joong Gon KIM
Journal of Korean Medical Science 2012;27(7):788-793
This study represents the first epidemiological study based on the national registry of primary immunodeficiencies (PID) in Korea. Patient data were collected from 23 major hospitals. A total of 152 patients with PID (under 19 yr of age), who were observed from 2001 to 2005, have been entered in this registry. The period prevalence of PID in Korea in 2005 is 11.25 per million children. The following frequencies were found: antibody deficiencies, 53.3% (n = 81), phagocytic disorders, 28.9% (n = 44); combined immunodeficiencies, 13.2% (n = 20); and T cell deficiencies, 4.6% (n = 7). Congenital agammaglobulinemia (n = 21) and selective IgA deficiency (n = 21) were the most frequently reported antibody deficiency. Other reported deficiencies were common variable immunodeficiencies (n = 16), X-linked agammaglobulinemia (n = 15), IgG subclass deficiency (n = 4). Phagocytic disorder was mostly chronic granulomatous disease. A small number of patients with Wiskott-Aldrich syndrome, hyper-IgE syndrome, and severe combined immunodeficiency were also registered. Overall, the most common first manifestation was pneumonia. This study provides data that permit a more accurate estimation PID patients in Korea.
Adolescent
;
Agammaglobulinemia/congenital/epidemiology
;
Age Distribution
;
Child
;
Child, Preschool
;
Common Variable Immunodeficiency/epidemiology
;
Female
;
Genetic Diseases, X-Linked/epidemiology
;
Humans
;
IgA Deficiency/epidemiology
;
IgG Deficiency/epidemiology
;
Immunologic Deficiency Syndromes/*epidemiology
;
Infant
;
Infant, Newborn
;
Job's Syndrome/epidemiology
;
Male
;
Prevalence
;
Questionnaires
;
Registries
;
Republic of Korea/epidemiology
;
Severe Combined Immunodeficiency/epidemiology
;
Sex Distribution
;
Wiskott-Aldrich Syndrome/epidemiology
;
Young Adult
5.Guidelines for the Treatment of Constipation.
Moo In PARK ; Jeong Eun SHIN ; Seung Jae MYUNG ; Kyu Chan HUH ; Chang Hwan CHOI ; Sung Ae JUNG ; Suck Chei CHOI ; Chong Il SOHN ; Myung Gyu CHOI
The Korean Journal of Gastroenterology 2011;57(2):100-114
While constipation is a common symptom in Korea, there are no existing treatment guidelines. Although constipation may occur as a result of organic cause, there is no obstructive mucosal or structural cause in the vast majority of patients with constipation. The present paper deals with only the management of functional constipation: lifestyle changes; bulking agents and stool softeners; osmotic agents; stimulant laxatives; prokinetics; biofeedback and surgical treatments. Exercise and dietary fiber are helpful in some patients with constipation. Laxatives including bulking agents, stool softeners, osmotic agents, and stimulant laxatives have been found to be more effective than placebo at relieving symptoms of constipation. New enterokinetic agents that affect peristalsis through selective interaction with 5-hydroxytryptamine-4 receptors can be effective in patients with constipation who cannot get adequate relief from current laxatives. Biofeedback can relieve symptoms in selected patients with pelvic floor dyssynergia. Surgical treatments can be helpful in some patients with refractory constipation.
Biofeedback, Psychology
;
Cathartics/therapeutic use
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Constipation/surgery/*therapy
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Dietary Fiber/therapeutic use
;
Electric Stimulation Therapy
;
Exercise Therapy
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Health Behavior
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Humans
;
Laxatives/therapeutic use
;
Serotonin 5-HT4 Receptor Antagonists/therapeutic use
;
Surface-Active Agents/therapeutic use
6.The evaluation of the correlation between histomorphometric analysis and micro-computed tomography analysis in AdBMP-2 induced bone regeneration in rat calvarial defects.
Shin Young PARK ; Kyoung Hwa KIM ; Ki Tae KOO ; Kang Woon LEE ; Yong Moo LEE ; Chong Pyoung CHUNG ; Yang Jo SEOL
Journal of Periodontal & Implant Science 2011;41(5):218-226
PURPOSE: Micro-computed tomography (micro-CT) has been widely used in the evaluation of regenerated bone tissue but the reliability of micro-CT has not yet been established. This study evaluated the correlation between histomorphometric analysis and micro-CT analysis in performing new bone formation measurement. METHODS: Critical-size calvarial defects were created using a 8 mm trephine bur in a total of 24 Sprague-Dawley rats, and collagen gel mixed with autogenous rat bone marrow stromal cells (BMSCs) or autogenous rat BMSCs transduced by adenovirus containing bone morphogenic protein-2 (BMP-2) genes was loaded into the defect site. In the control group, collagen gel alone was loaded into the defect. After 2 and 4 weeks, the animals were euthanized and calvaria containing defects were harvested. Micro-CT analysis and histomorphometric analysis of each sample were accomplished and the statistical evaluation about the correlation between both analyses was performed. RESULTS: New bone formation of the BMP-2 group was greater than that of the other groups at 2 and 4 weeks in both histomorphometric analysis and micro-CT analysis (P=0.026, P=0.034). Histomorphometric analysis of representative sections showed similar results to histomorphometric analysis with a mean value of 3 sections. Measurement of new bone formation was highly correlated between histomorphometric analysis and micro-CT analysis, especially at the low lower threshold level at 2 weeks (adjusted r2=0.907, P<0.001). New bone formation of the BMP-2 group analyzed by micro-CT tended to decline sharply with an increasing lower threshold level, and it was statistically significant (P<0.001). CONCLUSIONS: Both histomorphometric analysis and micro-CT analysis were valid methods for measurement of the new bone in rat calvarial defects and the ability to detect the new bone in micro-CT analysis was highly influenced by the threshold level in the BMP-2 group at early stage.
Adenoviridae
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Animals
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Bone and Bones
;
Bone Regeneration
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Collagen
;
Genetic Therapy
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Mesenchymal Stromal Cells
;
Osteogenesis
;
Rats
;
Rats, Sprague-Dawley
;
Skull
;
X-Ray Microtomography
7.Socket preservation using deproteinized horse-derived bone mineral.
Jang Yeol PARK ; Ki Tae KOO ; Tae Il KIM ; Yang Jo SEOL ; Yong Moo LEE ; Young KU ; In Chul RHYU ; Chong Pyoung CHUNG
Journal of Periodontal & Implant Science 2010;40(5):227-231
PURPOSE: The healing process following tooth extraction apparently results in a pronounced resorption of the alveolar ridge. As a result, the width of alveolar ridge is reduced and severe alveolar bone resorption occurs. The purpose of this experiment is to clinically and histologically evaluate the results of using horse-derived bone mineral for socket preservation. METHODS: The study comprised 4 patients who were scheduled for extraction as a consequence of severe chronic periodontitis or apical lesion. The extraction was followed by socket preservation using horse-derived bone minerals. Clinical parameters included buccal-palatal width, mid-buccal crest height, and mid-palatal crest height. A histologic examination was conducted. RESULTS: The surgical sites healed uneventfully. The mean ridge width was 7.75 +/- 2.75 mm at baseline and 7.00 +/- 2.45 mm at 6 months. The ridge width exhibited no significant difference between baseline and 6 months. The mean buccal crest height at baseline was 7.5 +/- 5.20 mm, and at 6 months, 3.50 +/- 0.58 mm. The mean palatal crest height at baseline was 7.75 +/- 3.10 mm, and at 6 months, 5.00 +/- 0.82 mm. There were no significant differences between baseline and 6 months regarding buccal and palatal crest heights. The amount of newly formed bone was 9.88 +/- 2.90%, the amount of graft particles was 42.62 +/- 6.57%, and the amount of soft tissue was 47.50 +/- 9.28%. CONCLUSIONS: Socket preservation using horse-derived bone mineral can effectively maintain ridge dimensions following tooth extraction and can promote new bone formation through osteoconductive activities.
Alveolar Process
;
Bone Resorption
;
Bone Substitutes
;
Chronic Periodontitis
;
Humans
;
Minerals
;
Osteogenesis
;
Tooth Extraction
;
Tooth Socket
;
Transplants
8.Biological effects of a porcine-derived collagen membrane on intrabony defects.
Chang Kyun LEE ; Ki Tae KOO ; Tae Il KIM ; Yang Jo SEOL ; Yong Moo LEE ; In Chul RHYU ; Young KU ; Chong Pyoung CHUNG ; Yoon Jeong PARK ; Jue Yeon LEE
Journal of Periodontal & Implant Science 2010;40(5):232-238
PURPOSE: To prolong the degradation time of collagen membranes, various cross-linking techniques have been developed. For cross-linking, chemicals such as formaldehyde and glutaraldehyde are added to collagen membranes, but these chemicals could adversely affect surrounding tissues. The aim of this study is to evaluate the ability of porous non-chemical cross-linking porcine-derived collagen nanofibrous membrane to enhance bone and associated tissue regeneration in one-wall intrabony defects in beagle dogs. METHODS: The second and third mandibular premolars and the first molars of 2 adult beagles were extracted bilaterally and the extraction sites were allowed to heal for 10 weeks. One-wall intrabony defects were prepared bilaterally on the mesial and distal side of the fourth mandibular premolars. Among eight defects, four defects were not covered with membrane as controls and the other four defects were covered with membrane as the experimental group. The animals were sacrificed 10 weeks after surgery. RESULTS: Wound healing was generally uneventful. For all parameters evaluating bone regeneration, the experimental group showed significantly superior results compared to the control. In new bone height (NBh), the experimental group exhibited a greater mean value than the control (3.04 +/- 0.23 mm/1.57 +/- 0.59, P = 0.003). Also, in new bone area (NBa) and new bone volume (NBv), the experimental group showed superior results compared to the control (NBa, 34.48 +/- 10.21% vs. 5.09 +/- 5.76%, P = 0.014; and NBv, 28.04 +/- 12.96 vs. 1.55 +/- 0.57, P = 0.041). On the other hand, for parameters evaluating periodontal tissue regeneration, including junctional epithelium migration and new cementum height, there were no statistically significant differences between two groups. CONCLUSIONS: Within the limitations of this study, this collagen membrane enhanced bone regeneration at one-wall intrabony defects. On the other hand, no influence of this membrane on periodontal tissue regeneration could be ascertained in this study.
Absorbable Implants
;
Adult
;
Animals
;
Bicuspid
;
Bone Regeneration
;
Collagen
;
Dental Cementum
;
Dogs
;
Epithelial Attachment
;
Formaldehyde
;
Glutaral
;
Guided Tissue Regeneration
;
Hand
;
Humans
;
Membranes
;
Molar
;
Regeneration
;
Wound Healing
9.Survey study of powered toothbrush with guiding device for oral hygiene improvement.
Yun Soo PARK ; Chul Woo LEE ; Byoung Do HAHM ; Ki Tae KOO ; Tae Il KIM ; Yang Jo SEOL ; Yong Moo LEE ; In Chul RHYU ; Young GU ; Chong Pyoung CHUNG
The Journal of the Korean Academy of Periodontology 2009;39(4):407-412
PURPOSE: This study was performed to evaluate the effect of powered toothbrush with a wireless remote display on the subjective and objective oral hygiene improvement. METHODS: One hundred and fifteen subjects in healthy or mild gingivitis status between the ages of 20 and 90 were recruited and reviewed for study inclusion criteria. At first visit, 115 pre-screened subjects filled in the questionnaire form which consisted of demographic factors, behavioral factors (smoking, alcohol consumption), toothbrushing habits (brushing time and frequency), self-reported oral health status, and self-satisfaction. Baseline clinical indices (Plaque index, Gingival index) were also recorded by a periodontist. Subjects were instructed how to use powered toothbrush with a wireless remote display, and were provided with it. Thirty days after first visit, 90 subjects returned for the second assessment by self-reported questionnaire form and professional clinical checkup. Statistical analysis was performed using paired t-test for the difference between baseline and second visit data. The relationship among variables was examined with chi-square test and Fisher's exact test. RESULTS: Significant differences were not found on self-reported satisfaction related with sex, smoking, alcohol consumption (P<0.05). Self-reported tooth brushing habit was improved in the aspect of brushing time and frequency. Significant differences were found on the self-reported oral health status, self-satisfaction, and clinical indices between the baseline and second visit data (P<0.01). Clinical indices were significantly reduced after using powered toothbrush with a wireless remote display (P<0.01). No adverse reactions were reported during the study period. CONCLUSIONS: Powered toothbrush with a wireless remote display successfully promoted oral hygiene from the subjective and objective viewpoint after 30 days of home usage.
Alcohol Drinking
;
Demography
;
Gingivitis
;
Oral Health
;
Oral Hygiene
;
Periodontal Index
;
Personal Satisfaction
;
Surveys and Questionnaires
;
Smoke
;
Smoking
;
Tooth
;
Toothbrushing
10.The influence of membrane exposure on post-extraction dimensional change following ridge preservation technique.
Hyun Wook NAM ; Yoon Jeong PARK ; Ki Tae KOO ; Tae Il KIM ; Yang Jo SEOL ; Yong Moo LEE ; Young GU ; In Chul RHYU ; Chong Pyoung CHUNG
The Journal of the Korean Academy of Periodontology 2009;39(3):367-373
PURPOSE: Following tooth extraction caused by severe periodontitis, alveolar ridge dimension lose their original volume. To reduce the alveolar ridge dimension, the ridge preservation technique has been introduced and tested in many clinical studies with membrane alone or membrane plus graft, achieving reduced ridge loss compared to extraction only. The aim of the present clinical study was to compare the post-extraction dimensional changes in the membrane exposure group to non-exposure group during healing period following ridge preservation technique. METHODS: Ridge preservation was performed in 44 extraction sites. After extraction, deproteinized bovine bone mineral coated with synthetic oligopeptide (Ossgen-X15(R)) or deproteinized bovine bone mineral (Bio-Oss(R)) was implanted into the socket. A collagen membrane (Bio-Gide(R)) was trimmed to cover the socket completely and applied to the entrance of the socket. Four clinical parameters were compared between baseline and 6 months. RESULTS: During healing period, membrane exposure was observed at 19 sites. At the re-entry, hard newly formed tissue were observed at the ridge preservation site. The grafted socket sites were well preserved in their volume dimension. In both groups, horizontal ridge width was reduced and vertical height was increased. There were not statistically significant differences in horizontal (-1.32 mm vs -1.00 mm) and vertical ridge change (2.24 mm vs 2.37 mm at buccal crest, 1.36 mm vs. 1.53 mm at lingual crest) between two groups. CONCLUSIONS: The ridge preservation approach after tooth extraction effectively prevented resorption of hard tissue ridge in spite of membrane exposure during healing period.
Alveolar Process
;
Bone Substitutes
;
Collagen
;
Membranes
;
Periodontitis
;
Tooth Extraction
;
Tooth Socket
;
Transplants

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