Purpose: We investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials. Materials and Methods: Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg/0.6 mL [3.6 mg G-CSF equivalent]) compared to pegfilgrastim (6 mg based on G-CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel/cyclophosphamide. The primary objective was to demonstrate non-inferiority of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN) in cycle 1, in Korean and Asian subpopulations. Results: Among a total of 643 patients randomized to eflapegrastim (n=314) or pegfilgrastim (n=329), 54 Asians (29 to eflapegrastim and 25 to pegfilgrastim) including 28 Koreans (14 to both eflapegrastim and pegfilgrastim) were enrolled. The primary endpoint, DSN in cycle 1 in the eflapegrastim arm was non-inferior to the pegfilgrastim arm in Koreans and Asians. The DSN difference between the eflapegrastim and pegfilgrastim arms was consistent across populations: –0.120 days (95% confidence interval [CI], –0.227 to –0.016), –0.288 (95% CI, –0.714 to 0.143), and –0.267 (95% CI, –0.697 to 0.110) for pooled population, Koreans and Asians, respectively. There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations. Conclusion This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population.

BACKGROUND: We examined the association between salivary mitochondrial DNA (mtDNA) copy number and chronic fatigue combined with depression and insomnia. METHODS: This cross-sectional study included 58 healthy adults with moderate to severe fatigue (Brief Fatigue Inventory [BFI] ≥4) for longer than 6 months. Subjects were classified as those without combined symptoms, with either depression (Beck Depression Inventory [BDI] ≥13) or insomnia (Pittsburgh Sleep Quality Index [PSQI] ≥5), or with both depression and insomnia. Salivary mtDNA copy number was measured by real-time quantitative polymerase chain reaction. The association was evaluated using a general linear model. RESULTS: About 76% of participants had either depression or insomnia as additional symptoms. These subjects were predominately female, drank more alcohol, and exercised less than those without combined symptoms (P<0.05). The group with both depression and insomnia exhibited significantly higher BFI and lower mtDNA copy number than those without combined symptoms (P<0.05). After adjusting for confounding factors, significant negative associations between mtDNA copy number and usual fatigue were found in the group without combined symptoms, whereas the negative associations in the group with combined symptoms were attenuated. BDI and PSQI were not associated with mtDNA copy number. CONCLUSION: Chronic fatigue is negatively associated with salivary mtDNA copy number. Salivary mtDNA copy number may be a biological marker of fatigue with or without combined symptoms, indicating that a separate approach is necessary.
Adult* ; Biomarkers ; Cross-Sectional Studies ; Depression ; Depressive Disorder ; DNA, Mitochondrial* ; Fatigue* ; Female ; Humans ; Linear Models ; Mental Fatigue ; Polymerase Chain Reaction ; Sleep Initiation and Maintenance Disorders ; Sleep Wake Disorders

BACKGROUND/AIMS: Peritoneal micrometastasis is known to play an important role in the recurrence of gastric cancer. However, its effects remain equivocal. Herein, we examine the messenger RNA (mRNA) as tumor markers, carcinoembryonic antigen (CEA), and cytokeratin 20 (CK20), in peritoneal washing fluid. Moreover, we evaluate whether these results could predict the recurrence of gastric cancer following curative resection. METHODS: We prospectively enrolled 132 patients with gastric cancers, who had received an operation, between January 2010 and January 2013. The peritoneal lavage fluid was collected at the operation field and semi-quantitative PCR was performed using the primers for CEA and CK20. We excluded patients with stage IA (n=28) early gastric cancer, positive cytologic examination of peritoneal washings (n=7), and those who were lost during follow up (n=18). RESULTS: A total of 79 patients with gastric cancers were enrolled, and the mean follow-up period was 39.95±19.25 months (range, 5-72 months). According to the multivariate analysis, T4 stage at the initial diagnosis was significantly associated with recurrence. All cases of recurrence were CEA positive and 6 cases were CK20 positive. The positive and negative predictive values of CEA were 32.0% and 100%, respectively, whereas those of CK20 were 37.5% and 71.4%, respectively. Disease free survival of CK20-negative cases was 36.17±20.28 months and that of CK20-positive cases was 32.06±22.95 months (p=0.39). CONCLUSIONS: It is unlikely that the real time polymerase chain reaction results of mRNA for CEA and CK20 in peritoneal washing fluid can predict recurrence. However, negative results can convince surgeons to perform curative R0 resection.
Biomarkers, Tumor ; Carcinoembryonic Antigen* ; Diagnosis ; Disease-Free Survival ; Follow-Up Studies ; Humans ; Keratin-20* ; Keratins* ; Multivariate Analysis ; Neoplasm Micrometastasis ; Peritoneal Lavage ; Polymerase Chain Reaction ; Prospective Studies ; Real-Time Polymerase Chain Reaction ; Recurrence ; RNA, Messenger* ; Stomach Neoplasms* ; Surgeons

OBJECTIVE: The complexity of the treatment for bipolar disorder is often caused by the presence of side effects of various psychiatric medications. In particular, weight gain and metabolic syndrome are currently major concerns in the medication for bipolar disorders. Therefore, we undertook a survey of expert opinion to help make clinical decisions in these special situations. METHODS: A written survey which asked about treatment strategies in the safety and tolerability was prepared; 1) weight gain, 2) antipsychotic related hyperprolactinemia, 3) lamotrigine related skin rash, 4) treatment non-adherence, and 5) genetic counselling. Treatment options were scored using a 9-point scale for rating appropriateness of clinical decisions in some issues. In other issues, experts were asked to choose to determine the ranking of preferences on the list. Sixty-four experts of the review committee completed the survey. We classified the expert opinions about preferences by chi2 test. RESULTS: Experts preferred behavioral and diet modification for weight gain, switching to prolactin-sparing-antipsychotics for antipsychotic-induced hyperprolactinemia, reducing dose of lamotrigene for its related benign skin rash, and prescribing once a day for treatment adherence. CONCLUSION: With the limitation of expert opinion, authors hope that the results of this study provide valuable information to make clinical decision about the treatment of bipolar disorder in the complicated situations.
Advisory Committees ; Bipolar Disorder* ; Exanthema ; Expert Testimony ; Food Habits ; Hope ; Hyperprolactinemia ; Weight Gain

BACKGROUND: Cardiovascular disease is the main cause of mortality in dialysis patients. Carotid intima-media thickness (CIMT) is used as a surrogate marker of early atherosclerosis. Atherosclerosis can cause vascular access failure.The purpose of this study was to define the clinical features of atherosclerosis in hemodialysis patients based on CIMT and to define the relationship between CIMT and access failure. METHODS: In this cross-sectional study, the CIMT of 60 patients on hemodialysis was examined using B-mode Doppler ultrasonography between May 2012 and November 2012. Carotid atherosclerosis was defined as a CIMT> or =0.9 mm or the incidence of atherosclerotic plaques. RESULTS: The patients' mean age was 54.5+/-10.6 years, and 60% of the patients were male. The CIMT was 0.81+/-0.47 mm (range, 0.35-2.50 mm).The group with atherosclerosis was characterized by older age compared with those without atherosclerosis. Patients with atherosclerosis showed much shorter durations of access patency than their counterparts in the nonatherosclerosis group (hazard ratio, 2.822; 95% confidence interval, 1.113-7.156; P=0.029). Moreover, being overweight was associated with a 2.47-fold (95% confidence interval,1.101-5.548) increased primary access failure. CONCLUSION: This study shows that atherosclerosis is associated with older age. Patients who are overweight and have atherosclerosis may have shortened access patency.
Atherosclerosis* ; Biomarkers ; Cardiovascular Diseases ; Carotid Artery Diseases ; Carotid Intima-Media Thickness ; Cross-Sectional Studies ; Dialysis ; Humans ; Incidence ; Male ; Mortality ; Overweight ; Plaque, Atherosclerotic ; Renal Dialysis* ; Ultrasonography, Doppler

Duchenne muscular dystrophy is a hereditary disorder characterized by progressive muscle weakness and contracture, and special care during anesthesia is needed in these patients. Because inhalational anesthetics and succinylcholine can cause fatal results, intravenous anesthetics are commonly used. However, monitorings for the pediatric population are not otherwise specified. We report our experience of a 6 year-old boy that underwent muscle biopsy suspicious of muscle dystrophy under general anesthesia. The patient received midazolam, fentanyl, propofol and a small dose of rocuronium. He was monitored with bispectral index (BIS), acceleromyography (TOF). At the end of surgery, recovery of TOF ratio to 90% was evaluated, followed by injection of pyridostigmine and glycopyrrolate. When reversal of neuromuscular block was confirmed quantitatively and clinically, the patient was extubated and he experienced no complication.
Androstanols ; Anesthesia ; Anesthesia, General ; Anesthetics ; Anesthetics, Intravenous ; Biopsy ; Contracture ; Fentanyl ; Glycopyrrolate ; Humans ; Midazolam ; Muscle Weakness ; Muscles ; Muscular Dystrophies ; Muscular Dystrophy, Duchenne ; Neuromuscular Blockade ; Organothiophosphorus Compounds ; Propofol ; Pyridostigmine Bromide ; Succinylcholine

PURPOSE: Patients with chronic kidney disease are predisposed to having a stroke. However, there are few data regarding the risk factors of stroke for the mortality and outcome in patients with chronic renal failure on dialysis. This retrospective study was conducted to evaluate the risk factors of stroke and its outcome in patients on dialysis at our hospital. METHODS: We retrospectively analyzed the data of dialysis patients who developed strokes from March 2001 to March 2009. The stroke was diagnosed on the history, physical examination and computed axial tomography or magnetic resonance imaging of the brain. The types of stroke were divided into ischemic or hemorrhagic stroke. RESULTS: The 120 patients were included in this study. Cerebral ischemia was 80 cases (66.7%) and cerebral hemorrhage was 39 cases (32.5%). One case had cerebral ischemia and hemorrhage simultaneously. Stroke occurred most frequently within 1 year after starting dialysis. Patients with cerebral infarction were older than patients with cerebral hemorrhage. Diabetes mellitus (DM) was more frequent in patient with cerebral infarction. Univariate and multivariate Cox analysis showed old age, hypertension and poor mental status are risk factors of mortality. Diuretics use reduced the mortality. CONCLUSION: The incidence of ischemic stroke is twice the higher than that of hemorrhagic stroke in the dialysis population. The risk factors of mortality were old age, hypertension, poor mental status and no diuretic use.
Brain ; Brain Ischemia ; Cerebral Hemorrhage ; Cerebral Infarction ; Diabetes Mellitus ; Dialysis ; Diuretics ; Hemorrhage ; Humans ; Hypertension ; Incidence ; Kidney Failure, Chronic ; Magnetic Resonance Imaging ; Physical Examination ; Renal Insufficiency, Chronic ; Retrospective Studies ; Risk Factors ; Stroke

A mycotic aneurysm is a localized, irreversible arterial dilatation resulting from destruction of the vessel wall by infection. Pathogens causing mycotic aneurysms include Gram-positive and -negative bacteria, mycobacteria, and fungi. Klebsiella pneumoniae is a common pathogen causing urinary tract infections, nosocomial pneumonia, soft tissue infection, pyogenic liver abscesses, and endophthalmitis, while mycotic aneurysms caused by K. pneumoniae are rare. Recently, the number of cases of endogenous K. pneumoniae endophthalmitis associated with K. pneumoniae-induced pyogenic liver abscesses has increased in Southern Asia, but there have been no reports of K. pneumoniae mycotic aneurysms accompanied by endophthalmitis. Here, we report the case of a man who had a K. pneumoniae mycotic aneurysm accompanied by endophthalmitis and, ultimately, lost sight in both eyes. The early diagnosis of associated endophthalmitis requires a high index of suspicion by the physician.
Aneurysm, Infected ; Aorta ; Asia ; Bacteria ; Dilatation ; Early Diagnosis ; Endophthalmitis ; Eye ; Fungi ; Glycosaminoglycans ; Klebsiella ; Klebsiella pneumoniae ; Liver Abscess, Pyogenic ; Pneumonia ; Soft Tissue Infections ; Urinary Tract Infections

PURPOSE: The traditional belief that obesity is protective against osteoporosis has been questioned. Recent epidemiologic studies show that body fat itself may be a risk factor for osteoporosis and bone fractures. Accumulating evidence suggests that metabolic syndrome and the individual components of metabolic syndrome such as hypertension, increased triglycerides, and reduced high-density lipoprotein cholesterol are also risk factors for low bone mineral density. Using a cross sectional study design, we evaluated the associations between obesity or metabolic syndrome and bone mineral density (BMD) or vertebral fracture. MATERIALS AND METHODS: A total of 907 postmenopausal healthy female subjects, aged 60-79 years, were recruited from woman hospitals in Seoul, South Korea. BMD, vetebral fracture, bone markers, and body composition including body weight, body mass index (BMI), percentage body fat, and waist circumference were measured. RESULTS: After adjusting for age, smoking status, alcohol consumption, total calcium intake, and total energy intake, waist circumference was negatively related to BMD of all sites (lumbar BMD p = 0.037, all sites of femur BMD p < 0.001) whereas body weight was still positively related to BMD of all sites (p < 0.001). Percentage body fat and waist circumference were much higher in the fracture group than the non-fracture group (p = 0.0383, 0.082 respectively). Serum glucose levels were postively correlated to lumbar BMD (p = 0.016), femoral neck BMD (p = 0.0335), and femoral trochanter BMD (p = 0.0082). Serum high density lipoprotein cholesterol (HDLC) was positively related to femoral trochanter BMD (p = 0.0366) and was lower in the control group than the fracture group (p = 0.011). CONCLUSION: In contrast to the effect favorable body weight on bone mineral density, high percentage body fat and waist circumference are related to low BMD and a vertebral fracture. Some components of metabolic syndrome were related to BMD and a vertebral fracture.
Aged ; Blood Glucose/metabolism ; Body Composition ; Body Mass Index ; Body Weight ; *Bone Density ; Female ; Humans ; Middle Aged ; Obesity/*complications/diagnosis ; Overweight ; *Postmenopause ; Republic of Korea ; Risk Factors ; Spinal Fractures/*complications/diagnosis

A 74-year-old male patient receiving ventilatory support due to aspiration pneumonia developed bilateral pneumothorax, pneumopericardium, pneumomediastinum, pneumo-retroperitoneum, and subcutaneous emphysema, after manual ventilation while being transferred from the intensive care unit (ICU) to the operating room (OR). These complications were assumed to be secondary to inappropriate manual ventilation of the intubated patient. In addition, it is likely that the possible migration of an already marginally acceptable endotracheal tube (ETT) position during transport was the cause of these complications. Finally, aggravation of a latent pneumothorax might have contributed to these complications.
Aged ; Barotrauma ; Humans ; Intensive Care Units ; Male ; Mediastinal Emphysema ; Operating Rooms ; Pneumonia, Aspiration ; Pneumopericardium ; Pneumothorax ; Subcutaneous Emphysema ; Ventilation