Bazedoxifene, used as bazedoxifene acetate, is a selective estrogen receptor modulator that selectively affects the uterus, breast tissue, bone metabolism, and lipid metabolism by antagonizing or enhancing estrogens in the estrogen receptor in the tissue. This study was conducted as an open, randomized, two-period, two-treatment, crossover design to compare the pharmacokinetic (PK) characteristics and tolerability of two bazedoxifene tablets when administered to 50 healthy Korean male volunteers. Enrolled subjects were randomly allocated to 2 sequences of a single oral administration of a test drug and a reference drug, or vice versa with a 14-day washout period between the two doses. Serial blood samples were collected over 96 h for PK analysis. Plasma concentration of bazedoxifene was assayed using liquid chromatography-tandem spectrometry mass. Forty-five participants completed the study with no clinically relevant safety issues. The peak concentrations (Cmax, mean ± strandard deviation) of reference drug and test drug were 3.191 ± 1.080 and 3.231 ± 1.346 ng/mL, respectively, and the areas under the plasma concentration‐time curve from 0 to the last measurable concentration (AUClast) were 44.697 ± 21.168 ng∙h/mL and 45.902 ± 23.130 ng∙h/mL, respectively. The geometric mean ratios of test drug to reference drug and their 90% confidence intervals for Cmax and AUClast were 0.9913 (0.8828–1.1132) and 1.0106 (0.9345–1.0929), respectively. The incidence of adverse events between the two formulations was similar. The present study showed that PK and tolerability of two bazedoxifene tablet formulations were comparable when administered to healthy Korean male volunteers.

PURPOSE: The aim of this study was to compare asparaginase-related toxicities in two asparaginase preparations, namely native Escherichia coli L-asparaginase (L-ASP) and pegylated asparaginase (PEG-ASP) in combination with ifosfamide, methotrexate, etoposide, and prednisolone (IMEP) in natural killer (NK)/T-cell lymphoma (NTCL). MATERIALS AND METHODS: A total of 41 NTCL patients who received IMEP plus native E. coli L-ASP or PEG-ASP at Seoul National University Hospital were included in this study between January 2013 and March 2016. IMEP/ASP treatment consisted of ifosfamide, methotrexate, etoposide, plus native E. coli L-ASP (6,000 IU/m2 on days 1, 3, 5, 7, 9, and 11) or PEG-ASP (2,500 IU/m2 on day 1) every 3 weeks. ASP-related toxicities, toxicity patterns, length of hospital stay, and clinical outcomes were compared between the different treatment groups. RESULTS: The frequency of ASP-related toxicities was similar between the IMEP plus native E. coli L-ASP group and the PEG-ASP group apart from hypofibrinogenemia (native E. coli L-ASP vs. PEG-ASP group, 86.4% vs. 36.8%; p=0.001). Although post-treatment transaminase and albumin levels were significantly high and low, respectively, hepatotoxicity gradients before and after treatment did not differ significantly between the groups. Since PEG-ASP was given at an outpatient clinic in some patients, length of hospital stay was significantly shorter in the IMEP plus PEG-ASP group (median, 4.0 vs. 6.0 days; p=0.002). A favorable tendency of clinical outcomes was observed in NTCL patients treated with IMEP plus PEG-ASP (complete remission rate, 73.7% vs. 45.5%; p=0.067). CONCLUSION: IMEP plus PEG-ASP showed similar ASP-related toxicities, shorter length of hospital stay, and a trend towards improved clinical outcomes compared with IMEP plus native E. coli L-ASP in NTCL.
Ambulatory Care Facilities ; Asparaginase* ; Escherichia coli* ; Escherichia* ; Etoposide* ; Humans ; Ifosfamide* ; Length of Stay ; Lymphoma* ; Methotrexate* ; Prednisolone* ; Seoul

BACKGROUND/AIMS: Several studies suggest that pyogenic liver abscess (PLA) is associated with colon neoplasm. A colonoscopic exam for cryptogenic PLA might detect a hidden colon neoplasm, through which intestinal flora can be transmitted into the liver. However, there are no prospectively enrolled cross-sectional data for colonic neoplasm in cryptogenic PLA. METHODS: Patients with PLA were prospectively enrolled from two university hospitals. Among them, all the patients with cryptogenic PLA were recommended for colonoscopic exam to check for colonic neoplasm. RESULTS: One hundred eighty-three patients with PLA were enrolled in the study for 22 months. One hundred and one (55.2%) patients did not have a definite cause of liver abscess at initial evaluation. The median diameter of the largest lesion was 5.7 cm (1.0-14.0 cm), and 74.3% of the patients were treated by percutaneous abscess drainage. Ninety-one percent of the patients who had an identified pathogen yielded Klebsiella. Sixty-two patients underwent colonoscopic exams, and no one had a colonic cancer, one had an adenomatous polyp with high grade dysplasia (1.6%), and 27 had adenomatous polyps with low grade dysplasia (43.5%; 41.0% in male and 43.5% in female). Of fifty patients who underwent an esophagogastroduodeno-scopic exam, nine had gastric ulcers, one had an esophageal ulcer, and one had hemorrhagic gastritis. CONCLUSIONS: The prevalence of colonic neoplasm among the patients with cryptogenic PLA was not as high as that in previous studies. Further well-designed, large-scale studies are required to assess the association of the colon neoplasm and cryptogenic PLA.
Abscess ; Adenomatous Polyps ; Colon* ; Colonic Neoplasms* ; Cross-Sectional Studies* ; Drainage ; Gastritis ; Gastrointestinal Microbiome ; Hospitals, University ; Humans ; Klebsiella ; Liver ; Liver Abscess ; Liver Abscess, Pyogenic* ; Male ; Prevalence* ; Prospective Studies* ; Stomach Ulcer ; Ulcer

BACKGROUND/OBJECTIVES: Despite the importance of a low-iodine diet (LID) for thyroid cancer patients preparing for radioactive iodine (RAI) therapy, few studies have evaluated dietary intake during LID. This study evaluated the amount of dietary iodine intake and its major food sources during a typical diet and during LID periods for thyroid cancer patients preparing for RAI therapy, and examined how the type of nutrition education of LID affects iodine intake. SUBJECTS/METHODS: A total of 92 differentiated thyroid cancer patients with total thyroidectomy were enrolled from Seoul National University Hospital. All subjects completed three days of dietary records during usual and low-iodine diets before 131I administration. RESULTS: The median iodine intake was 290 µg/day on the usual diet and 63.2 µg/day on the LID. The major food groups during the usual diet were seaweed, salted vegetables, fish, milk, and dairy products and the consumption of these foods decreased significantly during LID. The mean energy intake on the LID was 1,325 kcal, which was 446 kcal lower than on the usual diet (1,771 kcal). By avoiding iodine, the intake of most other nutrients, including sodium, was significantly reduced during LID (P < 0.005). Regarding nutritional education, intensive education was more effective than a simple education at reducing iodine intake. CONCLUSION: Iodine intake for thyroid cancer patients was significantly reduced during LID and was within the recommended amount. However, the intake of most other nutrients and calories was also reduced. Future studies are needed to develop a practical dietary protocol for a LID in Korean patients.
Dairy Products ; Diet Records ; Diet* ; Education ; Energy Intake ; Humans ; Iodine* ; Milk ; Seaweed ; Seoul ; Sodium ; Thyroid Gland* ; Thyroid Neoplasms* ; Thyroidectomy ; Vegetables

Lung cancer in never-smokers ranks as the seventh most common cause of cancer death worldwide, and the incidence of lung cancer in non-smoking Korean women appears to be steadily increasing. To identify the effect of genetic polymorphisms on lung cancer risk in non-smoking Korean women, we conducted a genome-wide association study of Korean female non-smokers with lung cancer. We analyzed 440,794 genotype data of 285 cases and 1,455 controls, and nineteen SNPs were associated with lung cancer development (P < 0.001). For external validation, nineteen SNPs were replicated in another sample set composed of 293 cases and 495 controls, and only rs10187911 on 2p16.3 was significantly associated with lung cancer development (dominant model, OR of TG or GG, 1.58, P = 0.025). We confirmed this SNP again in another replication set composed of 546 cases and 744 controls (recessive model, OR of GG, 1.32, P = 0.027). OR and P value in combined set were 1.37 and < 0.001 in additive model, 1.51 and < 0.001 in dominant model, and 1.54 and < 0.001 in recessive model. The effect of this SNP was found to be consistent only in adenocarcinoma patients (1.36 and < 0.001 in additive model, 1.49 and < 0.001 in dominant model, and 1.54 and < 0.001 in recessive model). Furthermore, after imputation with HapMap data, we found regional significance near rs10187911, and five SNPs showed P value less than that of rs10187911 (rs12478012, rs4377361, rs13005521, rs12475464, and rs7564130). Therefore, we concluded that a region on chromosome 2 is significantly associated with lung cancer risk in Korean non-smoking women.
Adenocarcinoma/*genetics/pathology ; Adult ; Aged ; Asian Continental Ancestry Group/*genetics ; Cell Adhesion Molecules, Neuronal/*genetics ; Chromosomes, Human, Pair 2 ; Female ; *Genome-Wide Association Study ; Genotype ; Humans ; Logistic Models ; Lung Neoplasms/*genetics/pathology ; Models, Genetic ; Nerve Tissue Proteins/*genetics ; Odds Ratio ; Polymorphism, Single Nucleotide ; Republic of Korea

OBJECTIVE: The objectives of this study were to analyze efficacy of immature and mature mouse oocytes after vitrification and warming by applying various combinations of cryoprotectants (CPAs) and/or super-rapid cooling using slush nitrogen (SN2). METHODS: Four-week old ICR female mice were superovulated for GV- and MII-stage oocytes. Experimental groups were divided into two groups. Ethylene glycol (EG) only group: pre-equilibrated with 1.5 M EG for 2.5 minutes and then equilibrated with 5.5 M EG and 1.0 M sucrose for 20 seconds. EG+dimethylsulfoxide (DMSO) group: pre-equilibrated with 1.3 M EG+1.1 M DMSO for 2.5 minutes and equilibrated with 2.7 M EG+2.1 M DMSO+0.5 M sucrose for 20 seconds. The oocytes were loaded onto grids and plunged into SN2 or liquid nitrogen (LN2). Stored oocytes were warmed by a five-step method, and then their survival, maturation, cleavage, and developmental rates were observed. RESULTS: The EG only and EG+DMSO groups showed no significant difference in survival of immature oocytes vitrified after warming. However, maturation and cleavage rates after conventional insemination were greater in the EG only group than in the EG+DMSO group. In mature oocytes, survival, cleavage, and blastocyst formation rates after warming showed no significant difference when EG only or EG+DMSO was applied. Furthermore, cleavage and blastocyst formation rates of MII oocytes vitrified using SN2 were increased in both the EG only and EG+DMSO groups. CONCLUSION: A combination of CPAs in oocyte cryopreservation could be formulated according to the oocyte stage. In addition, SN2 may improve the efficiency of vitrification by reducing cryoinjury.
Animals ; Blastocyst ; Cryopreservation ; Cryoprotective Agents ; Dimethyl Sulfoxide ; Ethylene Glycol ; Ethylenes ; Female ; Humans ; Insemination ; Mice ; Mice, Inbred ICR ; Nitrogen ; Oocytes ; Sucrose ; Vitrification

Fibrous hamartoma of infancy is a rare benign lesion that presents as a solitary, painless, flesh-colored, subcutaneous mass. Most of these lesions occur in the axillary region, the upper arm, the upper trunk, the inguinal area and the external genital area. The lesion histologically consists of three different components in varying proportions: well-defined fibrous trabeculae, primitive mesenchyme and, mature adipose tissue. Overlying skin changes are uncommon, including alternations in pigmentation, eccrine gland hyperplasia and increased hair. To the best of our knowledge, only 6 cases of fibrous hamartoma of infancy with hypertrichosis have been reported. In these six cases, the lesions were located on the buttocks and back, which were non-predilection sites. We report the first case of fibrous hamartoma of infancy with hypertrichosis on the axilla, which is known as a predilection site.
Adipose Tissue ; Arm ; Axilla ; Buttocks ; Eccrine Glands ; Hair ; Hamartoma ; Hyperplasia ; Hypertrichosis ; Mesoderm ; Pigmentation ; Skin

PURPOSE: This study examined the rate in which a diagnostic workup and treatment for osteoporosis are performed on patients with a hip fracture in Jeju Island, South Korea. MATERIALS AND METHODS: This study reviewed the medical records and radiographs of 174 patients (141 women and 33 men) older than 50 years and diagnosed with femoral neck or intertrochanteric fractures at 8 hospitals in Jeju Island during 2005. The mean age at the time of diagnosis was 78.3 years (range, 50-104 years). The number of patients examined with bone densitometry and treated for osteoporosis after the hip fracture was calculated. RESULTS: DXA was performed on 35 patients (20.1%) diagnosed with osteoporosis (T-score < -2.5). Of these 35 patients, 27 patients were treated for osteoporosis after a hip fracture. Among the 174 patients, only 27 patients (15.5%) had received medication for osteoporosis. CONCLUSION: The detection and treatment of osteoporosis are essential for reducing the incidence of another fracture after a hip fracture. However, a diagnostic study and the treatment for osteoporosis were performed only in a small portion of hip fracture patients.
Densitometry ; Diagnosis ; Female ; Femur Neck ; Hip Fractures* ; Hip* ; Humans ; Incidence ; Korea ; Medical Records ; Osteoporosis*

PURPOSE: Nebulizers are commonly used to treat children with asthma. Some pulmonary infections associated with contaminated nebulizer units have been reported. The aims of this study were to determine whether home nebulizers are repositories of bacteria and to ascertain how asthmatic patients use and maintain their nebulizers at home. METHODS: Fifty-five children with asthma aged 2 to 6 years were enrolled in this study. The parents were asked to bring their child's nebulizer units to regular follow-up visits. Bacterial samples which were obtained from the masks(or mouthpieces), nebulizer chambers and throat swabs were inoculated to blood agar, chocolate agar, and McConkey agar. Cultures were incubated at 5 percent CO2 incubator and observed after 24 hours. Parents completed a questionnaire regarding nebulizer usage and care in their child. RESULTS: Bacterial contamination was found in samples from 27(49.1%) of the 55 masks(or mouthpieces) and 24(43.6%) of the 55 chambers. The predominant microorganisms isolated were Acinetobacter baumannii, Bacillus subtilis, Klebsiella pneumoniae, Staphylococcus aureus, and Candida albicans. The questionnaire revealed that 40 parents cleaned the nebulizer units with tap water(and soap) and dried then, as they had received cleaning and drying instructions from a medical staff member. Seven organisms from nebulizer units were indistinguishable from the patient's throat isolates. CONCLUSION: We have demonstrated that home nebulizers in these asthmatic children were frequently contaminated with aerobic bacteria. Aerosolization might transmit these bacteria to their upper respiratory tracts. The education and training of home caregivers should include the principles of cleaning and maintenance of their child's nebulizer units.
Acinetobacter baumannii ; Agar ; Asthma ; Bacillus subtilis ; Bacteria ; Bacteria, Aerobic ; Cacao ; Candida albicans ; Caregivers ; Child* ; Education ; Follow-Up Studies ; Humans ; Incubators ; Inhalation ; Klebsiella pneumoniae ; Medical Staff ; Nebulizers and Vaporizers* ; Parents ; Pharynx ; Surveys and Questionnaires ; Respiratory System ; Staphylococcus aureus

OBJECTIVE: To evaluate the effects of etidronate disodium on bone and soft tissue, especially on bone mineral density, and mucosal changes of the aorta and esophagus. METHOD: Male Sprague-Dawley rats were randomly divided into 2 separate groups: one with etidronate disodium and one without etidronate disodium. Bone mineral density (BMD) in lumbar vertebrae, femur, and a simple X-ray of the whole body were obtained. The abdominal aorta and esophagus were assessed histopathologically in post treatment. RESULTS: In post treatment for 12 weeks, the extent of decrease in BMD of the group with etidronate disodium was less than that of the group without etidronate disodium (p<0.05). There was no evidence of aorta and heart valve calcification in the simple X-ray, nor was there intima-media thickening, atheroma formation and calcification in aorta and esophageal irritation findings in pathologic examinations in both groups. CONCLUSION: The results suggested that etidronate disodium had an inhibitory effect on bone mineral loss and had the esophageal tolerability and safety, but no difference in aorta calcification and antiarthrogenic effects, including aorta wall thickness in this study.
Aorta ; Aorta, Abdominal ; Bone Density ; Esophagus ; Etidronic Acid* ; Femur ; Heart Valves ; Humans ; Lumbar Vertebrae ; Male ; Plaque, Atherosclerotic ; Rats, Sprague-Dawley