Purpose: DA-8010 is a novel muscarinic M3 receptor antagonist with significant selectivity for bladder over salivary gland in preclinical studies. We evaluated the clinical efficacy and safety of DA-8010 in overactive bladder (OAB) patients. Methods: This phase 2, randomized, double-blind, parallel-group, active reference- and placebo-controlled trial was conducted at 12 centers in South Korea (NCT03566134). Patients aged ≥19 years with OAB symptoms for ≥3 months were enrolled. Three hundred six patients (30.07% male) were randomized to 12 weeks of treatment among 4 groups; 2 experimental groups (DA-8010 2.5 or 5 mg), an active reference group (solifenacin 5 mg), and a placebo group. The change from the baseline of (=∆) 24-hour frequency at 12 weeks (primary endpoint), episodes of urgency, overall/urgency urinary incontinence, average/ maximum voided volume, nocturia, and patients’ subjective responses were analyzed. Results: In the full analysis set, the mean (standard deviation) [median] values for ∆ 24-hour frequency at 12 weeks were -1.01 (2.44) [-1.33] for placebo, -1.22 (2.05) [-1.33] for DA-8010 2.5 mg, and -1.67 (2.25) [-1.67] for DA-8010 5 mg; DA-8010 5 mg showed a significant decrease compared with placebo (P=0.0413). At 4 and 8 weeks, both DA-8010 2.5 mg (P=0.0391 at 4 weeks, P=0.0335 at 8 weeks) and DA-8010 5 mg (P=0.0001 at 4 weeks, P=0.0210 at 8 weeks) showed significant decrease in ∆ 24-hour frequency compared with placebo. DA-8010 5 mg achieved a significant decrease in ∆ number of urgency episodes, compared with placebo at 4 (P=0.0278) and 8 (P=0.0092) weeks. Adverse drug reactions (ADRs) were observed in 3.95% of placebo, 6.67% of DA-8010 2.5 mg, 18.42% of DA-8010 5 mg, and 17.33% of solifenacin 5 mg groups. No serious ADRs were observed in any patient. Conclusions Both DA-8010 2.5 mg and 5 mg showed therapeutic efficacy for OAB without serious ADRs. Therefore, both dosages of DA-8010 can advance to a subsequent large-scale phase 3 trial.

PURPOSE: We aimed to investigate the epidemiological characteristics of Staphylococcus aureus bacteremia in Korean children. METHODS: We retrospectively collected and analyzed data from the medical records of the patients with S. aureus bacteremia ≤18 years of age in Gil Medical Center from 2002 to 2016. RESULTS: A total of 212 SAB cases were detected. The annual incidence of SAB from 2002 to 2016 ranged from 0.77 to 1.95 per 1,000 patients hospitalized. The neonate group (<28 days of age) and the pediatric group (28–18 years of age) were 51.4% (n=109) and 48.6% (n=103), respectively. According to the origin of infection, there were 93 cases (43.9%) of community-associated (CA)-SAB and 119 cases (56.1%) of healthcare-associated (HA)-SAB. The rates of HA-SAB among the neonate group and among the pediatric group were 64.2% and 47.6%, respectively (P=0.015). There was no difference in complications between CA-SAB and HA-SAB, but mortality was higher in HA-SAB. The proportion of methicillin-resistance S. aureus (MRSA) was the highest in neonates (88.1%), decreased with age, and was 36.4%–37.5% among children aged ≥5 years. The MRSA proportion was 72.2%, showing no consistent trend over the period. CONCLUSIONS: The annual incidence of SAB and the proportion of MRSA in SAB remained constant in the recent 15 years in children. Judicious decision of antimicrobial agents for treatment considering the patient's age and the origin of infection is necessary.
Anti-Infective Agents ; Bacteremia ; Child ; Epidemiology ; Humans ; Incidence ; Infant ; Infant, Newborn ; Medical Records ; Methicillin-Resistant Staphylococcus aureus ; Mortality ; Retrospective Studies ; Staphylococcus aureus ; Staphylococcus

OBJECTIVE: To evaluate the magnetic resonance (MR) imaging features that have a statistically significant association with the need for a tracheostomy in patients with cervical spinal cord injury (SCI) during the acute stage of injury.METHODS: This study retrospectively reviewed the clinical data of 130 patients with cervical SCI. We analyzed the factors believed to increase the risk of requiring a tracheostomy, including the severity of SCI, the level of injury as determined by radiological assessment, three quantitative MR imaging parameters, and eleven qualitative MR imaging parameters.RESULTS: Significant differences between the non-tracheostomy and tracheostomy groups were determined by the following five factors on multivariate analysis : complete SCI (p=0.007), the radiological level of C5 and above (p=0.038), maximum canal compromise (MCC) (p=0.010), lesion length (p=0.022), and osteophyte formation (p=0.015). For the MCC, the cut-off value was 46%, and the risk of requiring a tracheostomy was three times higher at an interval between 50–60% and ten times higher between 60–70%. For lesion length, the cut-off value was 20 mm, and the risk of requiring a tracheostomy was two times higher at an interval between 20–30 mm and fourteen times higher between 40–50 mm.CONCLUSION: The American Spinal Injury Association grade A, a radiological injury level of C5 and above, an MCC ≥50%, a lesion length ≥20 mm, and osteophyte formation at the level of injury were considered to be predictive values for requiring tracheostomy intervention in patients with cervical SCI.
Cervical Cord ; Humans ; Magnetic Resonance Imaging ; Multivariate Analysis ; Osteophyte ; Retrospective Studies ; Spinal Cord ; Spinal Injuries ; Spine ; Tracheostomy

PURPOSE: This study assessed the feasibility of near-infrared (NIR) imaging with indocyanine green (ICG) in investigating the completeness of laparoscopic lymph node (LN) dissection for gastric cancer. MATERIALS AND METHODS: Patients scheduled for laparoscopic gastrectomy for treating gastric cancer were enrolled in the study. After intraoperative submucosal ICG injection (0.05 mg/mL), LN dissection was performed under conventional laparoscopic light. After dissection, the LN stations of interest were examined under the NIR mode to locate any extra ICG-stained (E) tissues, which were excised and sent for pathologic confirmation. This technique was tested in 2 steps: infra-pyloric LN dissection (step 1) and review of all stations after proper radical node dissection (step 2). RESULTS: In step 1, 15 patients who underwent laparoscopic pylorus-preserving gastrectomy (LPPG) and 15 patients who underwent laparoscopic distal gastrectomy (LDG) were examined. Seven and 2 E-tissues were obtained during LPPG and LDG, respectively. From the retrieved E-tissues, 1 and 0 tissue obtained during LPPG and LDG, respectively, was confirmed as LN. In step 2, 20 patients were enrolled (13 D1+ dissection and 7 D2 dissection). Six E-tissues were retrieved from 5 patients, and 1 tissue was confirmed as LN in the pathologic review. Overall, 15 E-tissues were detected and removed, and 2 tissues were confirmed as LNs in the pathologic review. Both nodes were from LN station #6, with 1 case each in the LDG and LPPG groups. CONCLUSIONS: NIR imaging may provide additional node detection during laparoscopic LN dissection for gastric cancer, especially in the infra-pyloric area.
Diagnostic Imaging ; Gastrectomy* ; Humans ; Indocyanine Green* ; Lymph Node Excision* ; Lymph Nodes* ; Stomach Neoplasms*

BACKGROUND/OBJECTIVES: Recent studies showed vitamin D deficiency is linked to chronic diseases in addition to skeletal metabolism which could threaten the elderly. We analyzed health conditions and socio-demographic factors associated with vitamin D deficiency in community dwelling people aged 65 years and older. SUBJECTS/METHOD: Data from the Korea National Health and Nutrition Examination Survey (KNHANES) 2010 to 2012 were obtained. A total of 2,687 subjects aged 65 years and older were participated. The cutoff value of the Vitamin D deficiency was considered as serum 25-hydroxyvitamin D [25(OH)D] ≤ 20 ng/mL (50 nmol/L). RESULTS: The overall prevalence rate of vitamin D deficiency in the elderly was 62.1%. The factors such as female, obesity, metabolic syndrome, current smoker, and skipping breakfast were positively associated with vitamin D deficiency, but high intensity of physical activity and more than 9 hours of sleep duration were negatively associated with vitamin D deficiency (all P < 0.05). CONCLUSIONS: It is important that health professions know that the factors proved in this study are connected to vitamin D deficiency thus provide information and intervention strategies of vitamin D deficiency to old aged people.
Aged* ; Aging ; Breakfast ; Chronic Disease ; Female ; Health Occupations ; Humans ; Independent Living* ; Korea* ; Metabolism ; Motor Activity ; Nutrition Surveys ; Obesity ; Prevalence ; Risk Factors ; Vitamin D Deficiency* ; Vitamin D* ; Vitamins*

PURPOSE: Croup, a common childhood respiratory illness with various severities, has many unanswered questions. Laryngotracheobronchopneumonitis (LTBP) is a disease entity considered to be an extension of croup to the lower respiratory tract. The object of this study was to compare epidemiology, clinical characteristics, and viral etiologic spectrum between croup and LTBP. METHODS: Patients hospitalized with croup at Gachon University Gil Hospital from January 2010 to April 2016 were recruited. LTBP was defined as pneumonia confirmed on radiographs of patients with croup. Clinical findings and demographic data were reviewed of patients whose nasopharyngeal swabs were done for viral analysis. RESULTS: A total of 371 patients with only croup and 63 patients with LTBP were included. Croup was found to be significantly associated with parainfluenza virus type 1 (P=0.006). LTBP was related to parainfluenza virus type 3, respiratory syncytial virus, and human bocavirus (P=0.001, P=0.030, and P=0.019, respectively). The duration of fever was longer in patients with LTBP than in those with croup (3.87±1.85 days vs. 2.86±1.80 days, P<0.001). CONCLUSION: Specific etiologic viruses might be associated with the progression from croup to LTBP. Pronged fever is also associated with progression from croup to LTBP.
Child* ; Croup* ; Epidemiology ; Fever ; Human bocavirus ; Humans ; Parainfluenza Virus 1, Human ; Parainfluenza Virus 3, Human ; Pneumonia ; Respiratory Syncytial Viruses ; Respiratory System

OBJECTIVE: Magnetic resonance imaging (MRI) grading systems using sagittal images are useful for evaluation of lumbar foraminal stenosis. We evaluated whether such a grading system is useful as a diagnostic tool for surgery. METHODS: Between July 2014 and June 2015, 99 consecutive patients underwent unilateral lumbar foraminotomy for lumbar foraminal stenosis. Surgically confirmed foraminal stenosis and the contralateral, asymptomatic neuroforamen were assessed based on a 4-point MRI grading system. Two experienced researchers independently evaluated the MR sagittal images. Interobserver agreement and intraobserver agreement were analyzed using κ statistics. RESULTS: The mean age of patients (54 women, 45 men) was 62.5 years. A total of 101 levels (202 neuroforamens) were evaluated. MRI grades for operated neuroforamens were as follows: Grade 0 in 0.99%, Grade 1 in 5.28%, Grade 2 in 14.85%, and Grade 3 in 78.88%. Interobserver agreement was moderate for operated neuroforamens (κ=0.511) and good for asymptomatic neuroforamens (κ=0.696). Intraobserver agreement by reader 1 for operated neuroforamens was good (κ=0.776) and that for asymptomatic neuroforamens was very good (κ=0.831). In terms of lumbar level, interobserver agreement for L5–S1 (κ=0.313, fair) was relatively lower than the other level (κ=0.804, very good). CONCLUSION: MRI grading system for lumbar foraminal stenosis is thought to be useful as a diagnostic tool for surgery in the lumbar spine; however, it is less reliable for symptomatic L5–S1 foraminal stenosis than for other levels. Thus, various clinical factors as well as the MRI grading system are required for surgical decision-making.
Constriction, Pathologic* ; Female ; Foraminotomy ; Humans ; Lumbar Vertebrae ; Magnetic Resonance Imaging* ; Spinal Stenosis ; Spine

OBJECTIVE: To investigate whether serum levels of high-density lipoprotein (HDL) and apolipoprotein A-1 (ApoA1), after the return of spontaneous circulation, can predict the neurologic outcome in patients with out-of-hospital cardiac arrest (OHCA). METHODS: This was a retrospective observational study conducted in a single tertiary hospital intensive care unit. All adult OHCA survivors with admission lipid profiles were enrolled from March 2013 to December 2015. Good neurologic outcome was defined as discharge cerebral performance categories 1 and 2. RESULTS: Among 59 patients enrolled, 13 (22.0%) had a good neurologic outcome. Serum levels of HDL (56.7 vs. 40 mg/dL) and ApoA1 (117 vs. 91.6 mg/dL) were significantly higher in patients with a good outcome. Areas under the HDL and ApoA1 receiver operating curves to predict good outcomes were 0.799 and 0.759, respectively. The proportion of good outcome was significantly higher in patients in higher tertiles of HDL and ApoA1 (test for trend, both P=0.003). HDL (P=0.018) was an independent predictor in the multivariate logistic regression model. CONCLUSION: Admission levels of HDL and ApoA1 are associated with neurologic outcome in patients with OHCA. Prognostic and potential therapeutic values of HDL and ApoA1 merit further evaluation in the post-cardiac arrest state, as in other systemic inflammatory conditions such as sepsis.
Adult ; Apolipoprotein A-I* ; Apolipoproteins* ; Cholesterol, HDL ; Heart Arrest ; Humans ; Intensive Care Units ; Lipoproteins* ; Logistic Models ; Observational Study ; Out-of-Hospital Cardiac Arrest* ; Prognosis ; Retrospective Studies ; Sepsis ; Survivors ; Tertiary Care Centers

OBJECTIVE: The aim of this study was to predict the relationship between the symptomatic disc herniation level and the osteophyte level or decreased disc height in patients with cervical disc herniation. METHODS: Between January 2011 and December 2012, 69 patients with an osteophyte of the cervical spine underwent surgery at a single center due to soft cervical disc herniation. Data including soft disc herniation level, osteophyte level in the posterior vertebral margin, Cobb's angle, and symptom duration were retrospectively assessed. The patients were divided into three groups according to the relationship between the degenerative change level and the level of reported symptoms. RESULTS: Among the 69 patients, 48 (69.6%) showed a match between osteophyte level and soft disc herniation level. Disc herniation occurred at the adjacent segment to degenerative osteophyte level in 12 patients (17.4%) and at both the adjacent and the osteophyte level in nine (13.0%). There was no significant difference in Cobb's angle or duration among the three groups. Osteophyte type was not significant. The mean disc height of the prominent degenerative change level group was lower than the adjacent segment level, but this was not significant. CONCLUSION: Soft cervical disc herniation usually occurs at the level an osteophyte forms. However, it may also occur at segments adjacent to that of the osteophyte level. Therefore, in patients with cervical disc herniation, although a prominent osteophyte alone may appear on plain radiography, we must suspect the presence of soft disc herniation at other levels.
Humans ; Intervertebral Disc ; Intervertebral Disc Degeneration ; Osteophyte ; Radiography ; Retrospective Studies ; Spinal Fusion ; Spine

PURPOSE: Mycoplasma pneumoniae (MP) infection is a major cause of respiratory infection in school-aged children. Extrapulmonary manifestations of MP infection are common, but liver involvement has been rarely reported. The aim of this study was to determine the clinical characteristics of MP-associated hepatitis. METHODS: This prospective study included 1,044 pediatric patients with MP infection diagnosed serologically with MP IgM at one medical center from January 2006 to December 2012. Eighty of these patients had elevated levels of serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT), each greater than 50 IU/L, without any other specific liver disorder and were compared with the 964 children without liver disorders. RESULTS: In total, 7.7% of patients with MP infection had a diagnosis of hepatitis, especially in fall and winter. The ratio of male to female patients was 1.7:1, and the mean age of the patients was 5 years and 5 months. The most common symptoms were cough, fever, and sputum. Anorexia was the most common gastrointestinal symptom, followed by nausea/vomiting, diarrhea, and abdominal pain. Mean levels of AST and ALT were 100.65 IU/L and 118.73 IU/L, respectively. Serum AST/ALT level was normalized within 7.5 days on average without complications. The mean duration of hospitalization (11.3 days) was longer for children with hepatitis than for those without hepatitis (P=0.034). CONCLUSION: MP-associated hepatitis is not uncommon and has a relatively good prognosis. Therefore, clinicians should be concerned about liver involvement in MP infection but avoid further unnecessary evaluation of hepatitis associated with MP.
Abdominal Pain ; Alanine Transaminase ; Anorexia ; Aspartate Aminotransferases ; Child* ; Cough ; Diagnosis ; Diarrhea ; Female ; Fever ; Hepatitis* ; Hospitalization ; Humans ; Immunoglobulin M ; Liver ; Macrolides ; Male ; Mycoplasma pneumoniae* ; Pneumonia, Mycoplasma* ; Prognosis ; Prospective Studies* ; Sputum