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.

OBJECTIVE: To compare the long-term effect and safety of an epidural steroid injection in spinal stenosis patients, with or without local anesthetics. METHODS: Twenty-nine patients diagnosed with spinal stenosis were included and randomly divided into two groups. Translaminar epidural and selective nerve root spinal injection procedures were performed using steroids mixed with local anesthetics or normal saline. The effects of spinal injection procedures were measured with visual analogue scale (VAS) and functional rate index (FRI). These measurements were performed before injection, at 1 month after injection and at 3 months after injection. The occurrence of side effects was investigated each time. RESULTS: The VAS and FRI scores were significantly reduced in both the local anesthetics group and normal saline group at 1 and 3 months after the injection. However, there was no significant difference in VAS and FRI score reduction between the two groups each time. Side effects are not noted in both groups. CONCLUSION: The spinal injection procedures using steroids mixed either with local anesthetics or normal saline have an effect in reducing pain and improving functional activities. However, there was no significant difference between the two groups in relation to side effects and the long-term effects of pain and function.
Anesthetics ; Anesthetics, Local* ; Humans ; Injections, Epidural ; Injections, Spinal ; Spinal Stenosis* ; Steroids

The hematologic manifestations of human immunodeficiency virus (HIV) infection and acquired immune deficiency syndrome (AIDS) are common and may cause symptoms that are life threatening and impair the quality of life in these patients1). The most important of these manifestations is cytopenia. Among cytopenias, thrombocytopenia is caused by immune-mediated destruction of platelets, in addition to inadequate platelet production2). Thrombocytopenia has been reported in 5~15% of HIV-seropositive patients3). Profound thrombocytopenia (< 20,000/mm3) is rare (occurs in only 1.5% of cases) and presents only during advanced AIDS. With the exception of thrombocytopenia associated with advanced AIDS, severe thrombocytopenia in AIDS patients is extremely rare3). There are only a few reports of AIDS patients who first presented with severe thrombocytopenia. Here we report the case study of an AIDS patient who first presented with severe thrombocytopenia, mild abdominal distension, and edema in both lower legs. A brief review of the relevant literature is also presented.
Acquired Immunodeficiency Syndrome ; Blood Platelets ; Edema ; HIV ; Humans ; Leg ; Quality of Life ; Thrombocytopenia

The hematologic manifestations of human immunodeficiency virus (HIV) infection and acquired immune deficiency syndrome (AIDS) are common and may cause symptoms that are life threatening and impair the quality of life in these patients1). The most important of these manifestations is cytopenia. Among cytopenias, thrombocytopenia is caused by immune-mediated destruction of platelets, in addition to inadequate platelet production2). Thrombocytopenia has been reported in 5~15% of HIV-seropositive patients3). Profound thrombocytopenia (< 20,000/mm3) is rare (occurs in only 1.5% of cases) and presents only during advanced AIDS. With the exception of thrombocytopenia associated with advanced AIDS, severe thrombocytopenia in AIDS patients is extremely rare3). There are only a few reports of AIDS patients who first presented with severe thrombocytopenia. Here we report the case study of an AIDS patient who first presented with severe thrombocytopenia, mild abdominal distension, and edema in both lower legs. A brief review of the relevant literature is also presented.
Acquired Immunodeficiency Syndrome ; Blood Platelets ; Edema ; HIV ; Humans ; Leg ; Quality of Life ; Thrombocytopenia

PURPOSE: To evaluate the effectiveness and safety of fentanyl-TTS in the management of radiotherapy induced acute pain and cancer pain treated with radiotherapy. MATERIALS AND METHODS: Our study was open labelled prospective phase IV multi-center study. the study population included patients with more 4 numeric rating scale(NRS) score pain although managed with other analgesics or more than 6 NRS score pain without analgesics. Patients divided into two groups; patients with radiotherapy induced pain (Group A) and patients with cancer pain treated with radiotherapy (Group B). All patients received 25 ug/hr of fentanyl transdermal patch. Primary end point was pain relief; second end points were change in patient quality of life, a degree of satisfaction for patients and clinician, side effects. RESULTS: Between March 2005 and June 2005, 312 patients from 26 participating institutes were registered, but 249 patients completed this study. Total number of patients in each group was 185 in Group A, 64 in Group B. Mean age was 60 years and male to female ratio was 76:24. Severe pain NRS score at 2 weeks after the application of fentanyl was decreased from 7.03 to 4.01, p=0.003. There was a significant improvement in insomnia, social functioning, and quality of life. A degree of satisfaction for patients and clinician was very high. The most common reasons of patients' satisfactions was good pain control. Ninety six patients reported side effect. Nausea was the most common side effect. There was no serious side effect. CONCLUSION: Fentanyl-TTS was effective in both relieving pain with good tolerability and improving the quality of life for patients with radiotherapy induced acute pain and cancer pain treated with radiotherapy. The satisfaction of the patients and doctors was good. There was no major side effect.
Academies and Institutes ; Acute Pain ; Analgesics ; Female ; Fentanyl* ; Humans ; Male ; Nausea ; Prospective Studies ; Quality of Life ; Radiotherapy* ; Sleep Initiation and Maintenance Disorders ; Transdermal Patch*

PURPOSE: Infantile constipation is one of the most common problems in pediatric gastrointestinal outpatient clinic. We planed to show the clinical feature of infantile constipation and explore the possible relationship between diets and symptoms of constipation. METHODS: We analyzed the medical records and telephone questionnaire about infants under 2 years of age with constipation, who visited outpatient clinic of Department of Pediatrics, Ilsan Paik Hospital during the time from March 2002 to February 2005. Data including the symptoms and signs of constipation, diet history, and past-medical history were analyzed. RESULTS: Total 96 infants, 40 male and 56 female, were enrolled in this study. The mean age was 9 months. Twenty-three infants were exclusively breast milk fed (BMF), 20 infants were cow's milk fed (CMF) and 53 infants had a history of mixed feeding with cow's milk and breast milk (MMF). Patients showed painful defecation (95.8%), abdominal distension (53.1%), palpable rectal stool (35.1%), hard stool (30.2%), blood-tinged stool (29.2%) and anal fissure (16.7%). Patients with exclusive cow milk feeding had prominent clinical features, such as anal fissure (p=0.03), hematochezia (p=0.04) and palpable rectal stool (p=0.025). Patients who had a history of larger intake of liquid food had a tendency to get anal skin tag (p<0.05). CONCLUSION: Exclusive breast milk feeding seemed important to avoid constipation with clinical significance. To educate caregivers in appropriate way of the weaning food may help the infants with constipation.
Ambulatory Care Facilities ; Breast Feeding ; Caregivers ; Constipation* ; Defecation ; Diet ; Female ; Fissure in Ano ; Gastrointestinal Hemorrhage ; Humans ; Infant ; Male ; Medical Records ; Milk ; Milk, Human ; Pediatrics ; Surveys and Questionnaires ; Skin ; Telephone ; Weaning

BACKGROUND: Hypoxia-inducible factor-1alpha (HIF-1alpha) is an intrinsic marker of tumor hypoxia, and this is associated with reduced radiosensitivity. Furthermore, HIF-1alpha can increase a tumor's aggressiveness by promoting neoangiogenesis, cell proliferation and survival, and invasion. METHODS: The expression of HIF-1alpha was was investigated by performing immunohistochemistry on the cervical tissue specimens obtained from 57 patients who had received radiotherapy combined with or without chemotherapy for stages I-III cervical squamous cell carcinoma. The staining results were compared with anemia, the stage, the radiotherapy response and patient survival by univariate and multivariate analysis. RESULTS: In 57 patients, the expression of HIF-1alpha was seen in the tissue specimens of 46 patients (81.7%). Among them, 25 (54.3%), 14 (30.4%), and 7 (15.2%) of the patients' tissue specimens showed weak, moderate and strong expressions, respectively. Six patients had a partial response after radiotherapy. Twelve patients (21.1%) died of cervical cancer. The increased expression of HIF-1alpha was significantly associated (p<0.05) with the disease stage and anemia. There were significant positive correlations between the increased expression of HIF-1alpha and the poor response after radiotherapy and the patients' survival. CONCLUSIONS: The present result suggests that the overexpression of HIF-1alpha in the uterine cervix could be used as a prognostic indicator for the patients treated with radiotherapy.
Anemia ; Anoxia* ; Carcinoma, Squamous Cell* ; Cell Proliferation ; Cervix Uteri* ; Drug Therapy ; Female ; Humans ; Hypoxia-Inducible Factor 1 ; Immunohistochemistry ; Multivariate Analysis ; Radiation Tolerance ; Radiotherapy* ; Uterine Cervical Neoplasms

PURPOSE: The HER2 gene encodes a 185-kd transmembrane glycoprotein receptor (p185(HER2)) that has partial homology with the epidermal growth factor receptor (EGFR) and shares intrinsic tyrosine kinase activity. The HER2 gene has been found to be amplified in various human cancers and to be associated with poor prognosis. The authors investigated the correlation between clinicopathologic factors and the overexpression of the p185(HER2) in Korean gastric adenocarcinoma patients, and determined whether the antiproliferative effects of anti- p185(HER2) antibody can also be observed on gastric cancer cell lines that overexpress this growth factor receptor. MATERIALS AND METHODS: We evaluated the relationship between p185(HER2) overexpression and clinicopathological features in 94 (M: F=52: 42) gastric adenocarcinoma patients (median age 59 years). Protein expression was analysed by immunohistochemical staining in paraffin embedded tissues with monoclonal antibody for p185(HER2). To explore the role of humanized anti-p185(HER2) monoclonal antibody trastuzumab (Herceptin ) in vitro, the growth curve of Korean gastric cancer cells that overexpress the p185(HER2) protein was studied and a cell cycle analysis was performed. RESULTS: p185(HER2) overexpression correlates positively with lymph node metastasis (p=0.002), distant metastasis (p=0.01), AJCC classification (p=0.01), higher relapse rate p=0.001), and a tendential association with the pT stage (p=0.054). p185(HER2) overexpression was found to be more frequent in advanced gastric cancer than early gastric cancer (54.1% vs 24.2%, p=0.008). Patients with overexpression of p185(HER2) were found to have significantly lower relapse-free (p=0.003) and overall survival (p= 0.0004) than patients without overexpression. Among several Korean gastric cancer cell lines, SNU-1, SNU-5, and SNU-620 overexpress p185(HER2). Trastuzumab inhibited the proliferation of p185(HER2) overexpressed Korean gastric cancer cell line by 21% with down-regulation of p185(HER2) protein expression. DNA fluorescence flow cytometry of propidium iodide-stained nuclei showed a reduction in the fraction of the S phase following treatment with trastuzumab. CONCLUSIONS: Taken together, our observations suggest the potential prognostic significance of p185(HER2) overexpression in Korean gastric adenocarcinoma patients and point to the need for further research on this mechanism. This suggests the possible use of p185(HER2) as a therapeutic target in gastric cancer.
Adenocarcinoma ; Cell Cycle ; Cell Line* ; Classification ; DNA ; Down-Regulation ; Flow Cytometry ; Fluorescence ; Genes, erbB-2 ; Glycoproteins ; Humans ; Lymph Nodes ; Neoplasm Metastasis ; Paraffin ; Prognosis ; Propidium ; Protein-Tyrosine Kinases ; Receptor, Epidermal Growth Factor ; Recurrence ; S Phase ; Stomach Neoplasms ; Trastuzumab

PURPOSE: Brain metastasis is estimated to occur in 20~40% of solid tumor patients and the most common primary tumor is lung cancer. Even though the prognosis of brain metastasis is grave and the 1-year survival rate is only 15%, symptom palliations are made with whole brain radiation therapy. We retrospectively evaluated the clinical features and prognostic factors of lung cancer with brain metastasis. MATERIALS AND METHODS: From January 1987 to October 1999, 50 lung cancer patients with brain metastasis underwent whole brain radiation therapy. We reviewed the improvement in neurologic symptoms and survival according to the following parameters; performance status, histological type, presence of brain metastasis at the initial diagnosis of lung cancer, presence of extracranial metastasis, multiplicity of brain lesion, presence of primary lung symptom and treatment modalities. RESULTS: The most frequent symptom with brain metastasis was a headache (50%). Palliation of the headache and other symptoms was achieved in 81% of the patients. Median overall survival after brain metastasis was 21 weeks and the 1 year survival rate was 15%. Patients without extracranial metastasis had a longer median survival than those with, 38 weeks versus 15 weeks, respectively (p=0.01). CONCLUSION: In lung cancer with brain metastasis, neurologic symptoms can be palliated with whole brain radiation therapy, and in this study among such patients, absence of extracranial metastasis can be a good prognostic factor.
Brain* ; Diagnosis ; Headache ; Humans ; Lung Neoplasms* ; Lung* ; Neoplasm Metastasis* ; Neurologic Manifestations ; Prognosis* ; Retrospective Studies ; Survival Rate

PURPOSE: To evaluate the US and CT findings of abdominal wall endometrioma. MATERIALS AND METHODS: We respectively reviewed nine patients with abdominal wall masses diagnosed as endometrioma during a recent three-year period. Both US and CT scans were performed in six cases, only ultrasound in one, and only CT scans in two. The location, size, shape, margin, internal echo or density, enhancement patterns, and relation to adjacent masses, as seen on US and CT images, were reviewed. RESULTS: All patients had a previous history of deliveries by caesarian section. All masses were 2-4.5cm in size ; five were located in subcutaneous layers and four in musclel ayers. In all cases, sonographic findings were low echoic masses with irregular margins(7/7). Internal echotextures were inhomogeneous in five cases and homogeneous in two. On CT, masses in subcutaneous layers(5/8)showed spiculated margins and linear enhancement of the rectus muscle fascia. In cases of lesion located in muscle(3/8), slight thickening of the rectus muscle was visible on precontrast CT scans, but on postcontrast CT scans, well-defined enhancing masses, separate from the rectus muscle were seen. CONCLUSION: When patients with a previous history of caesarian section present palpable abdominal wall masses, with cyclic pain, sonographic findings of a low echoic mass separated from the internal organs, and CT findings of a strongly enhanced mass are useful for the diagnosis of endometrioma.
Abdominal Wall* ; Diagnosis ; Endometriosis* ; Fascia ; Female ; Humans ; Tomography, X-Ray Computed ; Ultrasonography*