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.

BACKGROUND/AIMS: The effect of proton pump inhibitors (PPI) in Asian functional dyspepsia (FD) patients has not been well established as in Western countries. DA-9701, a novel prokinetic agent, stimulates gastric emptying and modulates visceral hypersensitivity in vivo and in human studies. This study was conducted to compare the efficacy of DA-9701 with a conventional PPI in mono or combination therapy in patients with FD. METHODS: In this double-blind, randomized, non-inferiority trial, 389 patients diagnosed with FD using Rome III criteria were allocated among 3 groups: 30-mg DA-9701 t.i.d (means 3 times a day), 40-mg pantoprazole, and 30-mg DA-9701 t.i.d + 40-mg pantoprazole. The primary efficacy end-point was a global assessment of the patient binary response or response on a 5-Likert scale after 4 weeks. RESULTS: The global symptomatic improvement was 60.5% in the DA-9701 group, 65.6% in the pantoprazole group, and 63.5% in the DA-9701 + pantoprazole group using a 5-Likert scale at week 4 with no significant difference among 3 groups (P = 0.685). Symptom improvement measured by binary outcome was significantly achieved in each of the 3 groups, but not different among groups. Patients in all treatment groups reported significant improvement in the response rate and symptoms according to FD subtypes and dyspepsia-related quality of life (P < 0.001), but there were no significant differences among the 3 groups. CONCLUSIONS: DA-9701 improves global and individual symptoms and increases dyspepsia-specific quality of life in patients with FD. The efficacy of DA-9701 monotherapy is comparable with pantoprazole and there is no additive effect with combination of DA-9701 and pantoprazole in patients with FD.
Asian Continental Ancestry Group ; Dyspepsia* ; Gastric Emptying ; Humans ; Hypersensitivity ; Proton Pump Inhibitors ; Quality of Life

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

In most cases of amyotrophic lateral sclerosis (ALS), respiratory muscle involvement is a late complication. Only 2.7% of ALS patients presenting with their first clinical symptoms in the extremities also experience respiratory symptoms. We report a case of an 81-year-old man with ALS, diagnosed by an unexplained failure to wean from mechanical ventilation. The patient was presented with acute respiratory failure, tachypnea and respiratory acidosis. Computed tomography of the chest showed large amounts of sputum in the trachea. An endotracheal tube was inserted, and the patient was placed on volume-controlled ventilation. However, in the course of recovery, he could not be weaned from mechanical ventilation, despite the absence of cardiopulmonary impairment. Having considered other causes of respiratory failure, wediagnosed ALS after a physical and neurologic examination and electrodiagnostic testing.
Acidosis, Respiratory ; Aged, 80 and over ; Amyotrophic Lateral Sclerosis ; Extremities ; Humans ; Neurologic Examination ; Respiration, Artificial ; Respiratory Insufficiency ; Respiratory Muscles ; Sputum ; Tachypnea ; Thorax ; Trachea ; Ventilation

BACKGROUND: Since 2001, the Ministry of Health and Welfare in Korea has designated muscular dystrophy (MD) to be a rare and intractable disease, and has ensured that patients with this condition obtain support from the National Health Insurance Corporation for their medical expenditure. However, the health-related and socioeconomic status of Korean patients with MD has yet to be established. METHODS: We selected 441 patients with MD who received medical services at 17 neuromuscular centers during 2005. The medical records of selected patients were analyzed, and the subtype of MD was classified by its clinical course and diagnostic tests. A total of 95 patients or their family members participated in this health-related and socioeconomic status survey. RESULTS: Medical record analysis showed similar clinical and diagnostic characteristic data to those published previously in other countries: male predominance, being young at onset, and muscular weakness of the extremities as a predominant symptom in most patients. The diagnostic tests for MD were based on laboratory and electrophysiological studies. The most frequent form of MD among our cohort was Duchenne/Becker muscular dystrophy (42%). Our survey revealed the effect of the patients' profound disability on their activities of daily living. One-half of the patients were dissatisfied with the medical expenditure support service that was made available to them, and most patients suffered from a financial burden. The most important medical services to be developed in the future are expansion of the public health service or development of a rehabilitation hospital. CONCLUSIONS: This is the first multicenter-based epidemiologic study on the health-related and socioeconomic status of patients with MD in Korea. The findings indicate that medical coverage and public health service are currently inadequate and hence should be expanded in the future.
Activities of Daily Living ; Cohort Studies ; Diagnostic Tests, Routine ; Epidemiologic Studies ; Extremities ; Health Expenditures ; Humans ; Korea ; Male ; Medical Records ; Morphinans ; Muscle Weakness ; Muscular Dystrophies ; National Health Programs ; Social Class ; United States Public Health Service

PURPOSE: The objective of this study was to evaluate the risk factors associated with agricultural machinery-related injuries, and to develop strategies to control and prevent such injuries. METHODS: The medical records of 148 patients who visited the emergency department of Chosun University Hospital with a history of agricultural machinery-related injuries from January 2005 to December 2006 were examined. Injury rates were categorized by age, sex, underlying disease, place and time of injury, mechanism of accident, kind of machine and final diagnosis, Injury severity was calculated by using TRISS method and compared. RESULTS: 148 cases of agricultural machinery-related injuries were identified. Most cases involved men(85.1%) and occurred between 4 p.m. and 8 p.m., with seasonal peaks in autumn and spring. The largest number of cases involved men in their sixties(33.2%) with a mean age of 57.5. Significant risk factors for injury were age over fifty, transferred patient, accident on main road , and patients of passenger seat or trunk when the accident occurred. Extremities were more vulnerable than other body areas, and injuries of the abdomen, head, and neck had higher fatality and mortality rate. The overall mortality rate was 12.8%. CONCLUSIONS: Agricultural machinery-related injuries have a high case fatality rate. Physicians must be able to make rapid, accurate assessments of the injured farmer, taking into account environmental factors that may cause additional problems, and active care of the injured farmer must be initiated at the rural hospital in order for optimal recovery to take place. There will be a need to develop strategies for prevention of these injuries and for educational programs.
Abdomen ; Agriculture ; Diagnosis ; Emergency Service, Hospital ; Extremities ; Head ; Hospitals, Rural ; Humans ; Male ; Medical Records ; Mortality ; Neck ; Risk Factors* ; Seasons

A 36-year-old female who initially presented with a small erythematous and swollen abscess on her left anterior tibial area was found out to have a cutaneous Mycobacterium abscessus infection. She was first treated with incision and drainage, dressing, and antibiotics. The lesion began to be aggravated and dispersed. Neither aerobic nor anaerobic bacteria was grown on blood agar plate. After a few weeks, Mycobacterium grew on Ogawa media after 6 days, and was identified as M. abscessus by PCR-restriction fragment length polymorphism. She was then treated with clarithromycin, levofloxacin, and amikacin, and the skin lesion was resolved without further recurrence.
Abscess ; Adult ; Agar ; Amikacin ; Anti-Bacterial Agents ; Bacteria, Anaerobic ; Bandages ; Clarithromycin ; Drainage ; Female ; Humans ; Levofloxacin ; Mycobacterium* ; Recurrence ; Skin* ; Soft Tissue Infections*

PURPOSE: The aim of this study was to develop recombinant human Bone Morphogenetic Protein-7 (BMP7)-stable cells and recombinant human BMP7 adenoviruses (AdBMP7) for osteoinduction and osteoregeneration in musculoskeletal diseases. MATERIALS AND METHODS: The human BMP7 cDNA was amplified from a human osteosarcoma cell line, U2OS using a reverse transcription-polymerase chain reaction and cloned into a eukaryotic expression vector. The BMP7-stable HEK293 cells (HEK293/BMP7) were prepared by transfecting the recombinant BMP7 plasmid vector. The recombinant human BMP7 adenovirus (AdBMP7) was constructed using the AdEasy vector system. The BMP7 expression levels in HEK293/BMP7 and AdBMP7 were measured by activity staining for alkaline phosphatase in mouse C2C12 promyoblast cells. The BMP7-stable HEK293 cells, AdBMP7 itself, or AdBMP7-transduced human fibroblasts were injected into the subcutaneous tissues and the calf muscles of immunocompromised mice. The amount of ectopic bone formation was evaluated by radiographic and histological analyses. RESULTS: Ectopic bone formation was observed after injecting the BMP7-stable HEK293 cells with either the AdBMP7 itself or AdBMP7-transduced human fibroblasts into the subcutaneous tissues and calf muscles of immunocompromised mice. CONCLUSION: These results showed that HEK293/BMP7 cells and AdBMP7 have a significant potential for bone formation and the regeneration of various bone diseases.
Adenoviridae ; Alkaline Phosphatase ; Animals ; Bone Diseases ; Cell Line ; Clone Cells ; DNA, Complementary ; Fibroblasts ; Genetic Therapy ; HEK293 Cells ; Humans ; Mice ; Muscles ; Musculoskeletal Diseases ; Osteogenesis ; Osteosarcoma ; Plasmids ; Regeneration ; Subcutaneous Tissue

PURPOSE: To measure bending stiffness of rod in pedicle screw systems and identify the optimal rod for surgical correction of spinal deformities. MATERIALS AND METHODS: Bending stiffness of six different rods -7 mm stainless steel, 6 mm titanium alloy, 6.35 mm titanium, 5.5 mm titanium, 6 mm Shape Memory Alloy after martensite temperature, 7 mm Shape Memory Alloy after martensite temperature were measured by MTS 858 Bionix test system according to the ASTM standards. The specimen number was 8 for each rod. Young's modulus of elasticity was calculated from load-displacement data. RESULTS: Seven-mm stainless steel rod was stiffer than any other rods with bending stiffness of 143.7 +/- 3.8 N/mm, and also showed largest Young's modulus of elasticity of 135.1 +/- 3.0 GPa. Six-mm Shape Memory Alloy rod after martensite temperature was most flexible with bending stiffness of 58.1 +/- 2.8 N/mm, and showed smallest Young's modulus of elasticity of 68.0 +/-2.1 GPa. Seven-mm Shape Memory Alloy rod after martensite temperature was similar to the 6.35 mm titanium and 6 mm titanium alloy rod in bending stiffness and Young's modulus of elasticity. CONCLUSION: Seven-mm stainless steel rod was the stiffest rod tested, which is necessary to improve correction rate and maintain achieved correction. However, the rod selection should be individulized since stiffer rod might increase the chance of acute failure. Seven-mm Shape Memory Alloy could be more useful in deformity correction than 6 mm Shape Memory Alloy since it was not only similar to other rods in stiffness but also had shape memory function which would be necessary to establish the desired position of the spine.
Alloys ; Congenital Abnormalities ; Elastic Modulus ; Elasticity ; Memory ; Spine ; Stainless Steel ; Titanium

Primitive neuroectodermal tumors(PNETs) and medulloblastoma are common primary malignant brain tumors of childhood. Untreated patients are proven to be fatal, but the current treatment regimens may achieve 50% to 60% cures. However, the prognosis of each individual case can not be accurately determined, because exact prognostic factors have not been established. The aim of this study was to investigate whether various factors were correlated with clinical outcome, and to understand their roles in the oncogenesis. Twenty-five patients with medulloblastoma and nine patients with supratentorial PNETs were reviewed(mean follow-up periods: 25.6 months). We have investigated the prognostic value of p53 protein and other oncogene expression by immunohistochemistry and DNA analysis by flow cytometry on paraffin section of the specimen. We also studied the other prognostic factors such as clinical features, tumoral factors, and treatment modalities as well. The positive expressions of p53 protein, c-myc, and pan-ras were significantly high in these tumors. With DNA flow cytometry, 18 were aneuploid and 8 were diploid. There was no significant prognostic correlation between the immunoreactivity of p53, oncogene expression, and DNA ploidy. Only the stage of tumor(T, M stage; p=0.0002, 0.0418, respectively) and chemotherapy(p=0.0433) were correlated with their prognosis. We conclude that further special investigations should be added to justify the prognostic factors for these highly malignant tumors.
Aneuploidy ; Brain Neoplasms ; Carcinogenesis ; Diploidy ; DNA ; Flow Cytometry ; Follow-Up Studies ; Humans ; Immunohistochemistry ; Medulloblastoma* ; Neural Plate ; Neuroectodermal Tumors, Primitive* ; Oncogenes ; Paraffin ; Ploidies ; Prognosis*