OBJECTIVE: This study aimed to evaluate the clinical efficacy, safety, and tolerability of paliperidone extended release (ER) in patients with schizophrenia by switching previous antipsychotics to paliperidone ER. METHODS: An open-label, 24 weeks, prospective, non-comparative, multi-center study evaluated total 387 patients with schizophrenia requiring a switch in antipsychotic medication due to suboptimal efficacy, intolerability, and non-compliance. Patients were switched to flexible-dose trial of paliperidone ER (3-12 mg/day). Efficacy was measured by Krawiecka Scale, Clinical Global Impression-Schizophrenia-Severity (CGI-SCH-S), Clinical Global Impression-Schizophrenia-Improvement (CGI-SCH-I), sleep visual analog scale (VAS), and Personal and Social Performance Scale (PSP). Safety assessments included adverse events (AEs), evaluation of extrapyramidal symptoms (EPS) using the Drug Induced Extrapyramidal Symptoms Scale (DIEPSS), and laboratory tests. RESULTS: Data from a total of 321 subjects who took the paliperidone ER and had at least one follow-up assessment without a major protocol violation were analyzed. Switching to paliperidone ER led to a significant improvement in the Krawiecka, CGI-SCH-S, CGI-SCH-I, PSP, and DIEPSS scales. However, serum prolactin levels and metabolic parameters including body weight and waist circumference were significantly increased. Insomnia was the most common adverse event. CONCLUSION: This study suggested that patients with schizophrenia who showed insufficient response or intolerance to other previous antipsychotics can be switched to paliperidone ER, with efficacy, safety, and tolerability.
Antipsychotic Agents ; Body Weight ; Follow-Up Studies ; Humans ; Isoxazoles ; Prolactin ; Prospective Studies ; Pyrimidines ; Schizophrenia ; Sleep Initiation and Maintenance Disorders ; Waist Circumference ; Weights and Measures

Citrullinemia type I is an urea cycle defect caused by mutations in the argininosuccinate synthetase (ASS1) gene. We report a novel argininosuccinate synthetase gene mutation in a Korean family with type I citrullinemia. Metabolic evaluation revealed significant hyperammonemia. Amino acid/acylcarnitine screening using tandem mass spectrometry showed high level of citrulline. Plasma amino acid analysis showed high level of citrulline and the urine organic acid analysis showed makedly increased level of orotic acid. To confirm diagnosis of citrullinemia we did mutation analysis of the ASS1 gene. The patient was found to have mutations of c.689G>C (p.G230A) and c.892G>A (p.E298K), which were new types of argininosuccinate synthetase gene mutation have never been reported in Korea. We report a novel case of argininosuccinate synthetase 1 gene mutation and suggest that the gene study to the family members is necessary to carry out when a patient is diagnosed as citrullinemia.
Argininosuccinate Synthase ; Citrulline ; Citrullinemia ; Humans ; Hyperammonemia ; Korea ; Mass Screening ; Orotic Acid ; Plasma ; Tandem Mass Spectrometry ; Urea

Citrullinemia type I is an urea cycle defect caused by mutations in the argininosuccinate synthetase (ASS1) gene. We report a novel argininosuccinate synthetase gene mutation in a Korean family with type I citrullinemia. Metabolic evaluation revealed significant hyperammonemia. Amino acid/acylcarnitine screening using tandem mass spectrometry showed high level of citrulline. Plasma amino acid analysis showed high level of citrulline and the urine organic acid analysis showed makedly increased level of orotic acid. To confirm diagnosis of citrullinemia we did mutation analysis of the ASS1 gene. The patient was found to have mutations of c.689G>C (p.G230A) and c.892G>A (p.E298K), which were new types of argininosuccinate synthetase gene mutation have never been reported in Korea. We report a novel case of argininosuccinate synthetase 1 gene mutation and suggest that the gene study to the family members is necessary to carry out when a patient is diagnosed as citrullinemia.
Argininosuccinate Synthase ; Citrulline ; Citrullinemia ; Humans ; Hyperammonemia ; Korea ; Mass Screening ; Orotic Acid ; Plasma ; Tandem Mass Spectrometry ; Urea

PURPOSE: We studied to know the influence of respiratory virus and atopic characteristics on recurrence of virus-induced wheezing in children under 3 years of age. METHODS: Between March 2006 and February 2009, 340 children who were hospitalized with symptoms of sudden onset of dyspnea, cough and wheezing after symptoms of acute upper respiratory tract infection and detected specific respiratory viruses by multiplex RT-PCR were enrolled. The data were analyzed according to age (< or =6, 7-12, 13-24, and 25-36 months) as well as previous wheezing episodes (first or recurrent episode). Respiratory viruses and atopic characteristics were compared among individual groups. RESULTS: The 3 commonly identified viruses were RSV (62.4%), PIV (15.6%) and RV (11.8%). PIV and RV were significantly associated with recurrence, but RSV was not significantly associated with recurrence. Food sensitization, aeroallergen sensitization, elevation of total IgE, history of atopic dermatitis and history of parent asthma were significantly associated with the recurrent episode, but serum eosinophil and passive smoking were not significantly associated with the recurrent episode. CONCLUSION: These findings show that specific respiratory viruses can have different influence on recurrence and that atopy may be a risk factor for recurrence of wheezing, in children under 3 years of age with virus-induced wheezing.
Asthma ; Child ; Cough ; Dermatitis, Atopic ; Dyspnea ; Eosinophils ; Humans ; Immunoglobulin E ; Parents ; Recurrence ; Respiratory Sounds ; Respiratory Tract Infections ; Risk Factors ; Tobacco Smoke Pollution ; Viruses

BACKGROUND: Caspase-3 is a cysteine protease that plays a major role in the process of apoptotic cell death. The dysregulated expression of c-myc contributes to the tumorigenesis in a variety of human cancers. The aim of this study was to investigate the expressions of caspase-3 and c-myc and their significances as prognosis markers in patients with completely resected non-small cell lung cancer (NSCLC). MATERIAL AND METHOD: A total 130 consecutive patients who had undergone complete resection without pre-operative radio-therapy or chemotherapy between May 1996 and December 2003 for NSCLC were retrospectively reviewed. The median follow-up period of the patients was 50 months (range: 3~128 months). The expressions of caspase-3 and c-myc were immunohistochemically examined, and these were correlated with the clinico-pathologic data. RESULT: The prevalence of caspase-3 and c-myc expressions in the patients was 68% (88/130) and 59% (77/130), respectively. Significant association was found between the frequency of the expressions of caspase-3 and c-myc (p=0.025). The caspase-3 and c-myc expressions were not significantly associated with the prognosis in all the patients. However, according to stages, a positive caspase-3 expression was significantly correlated with a favorable prognosis for patients with stage IIIa disease (median survival period: 35 months vs. 10 months, p=0.021). Multivariate analysis showed the pathologic stage to be significantly correlated with a good prognosis in all the patients (p=0.024), and with a positive caspase-3 expression, well differentiated tumor and negative neuronal invasion in the patients with stage IIIa disease (p=0.005, p=0.003, p=0.004, respectively). CONCLUSION: Caspase-3 and c-myc were frequently expressed in NSCLC, suggesting its possible involvement in tumor development. The caspase-3 expression, as determined with performing immunohistochemical staining, may be a favorable prognostic indicator in patients with completely resected NSCLC of an advanced stage (IIIa).
Carcinoma, Non-Small-Cell Lung ; Caspase 3 ; Cell Death ; Cell Transformation, Neoplastic ; Cysteine Proteases ; Follow-Up Studies ; Humans ; Multivariate Analysis ; Neurons ; Prevalence ; Prognosis ; Retrospective Studies

PURPOSE: To analyze the response, toxicity, patterns of failure and survival rate of patients with locally advanced non-small cell lung cancer who were treated with concurrent chemoradiotherapy with weekly paclitaxel. MATERIALS AND METHODS: Twenty-three patients with locally advanced non-small cell lung cancer patients who received radical chemoradiotherapy from October 1999 to September 2004 were included in this retrospective study. Patients received total 55.4~64.8 (median 64.8) Gy (daily 1.8 Gy per fraction, 5 days per weeks) over 7~8 weeks. 50 or 60 mg/m2 of paclitaxel was administered on day 1, 8, 15, 22, 29 and 36 of radiotherapy. Four weeks after the concurrent chemoradiotherapy, three cycles of consolidation chemotherapy consisted of paclitaxel 135 mg/m2 and cisplatin 75 mg/m2 was administered every 3 weeks. RESULTS: Of the 23 patients, 3 patients refused to receive the treatment during the concurrent chemoradiotherapy. One patient died of bacterial pneumonia during the concurrent chemoradiotherapy. Grade 2 radiation esophagitis was observed in 4 patients (17%). Sixteen patients received consolidation chemotherapy. During the consolidation chemotherapy, 8 patients (50%) experienced grade 3 or 4 neutropenia and one of those patients died of neutropenic sepsis. Overall response rate for 20 evaluable patients was 90% including 4 complete responses (20%) and 14 partial responses (70%). Among 18 responders, 9 had local failure, 3 had local and distant failure and 2 had distant failure only. Median progression-free survival time was 9.5 months and 2-year progression-free survival rate was 19%. Eleven patients received second-line or third-line chemotherapy after the treatment failure. The median overall survival time was 21 months. 2-year and 5-year survival rate were 43% and 33%, respectively. Age, performance status, tumor size were significant prognostic factors for progression-free survival. CONCLUSION: Concurrent chemoradiotherapy with weekly paclitaxel revealed high response rate and low toxicity rate. But local failure occurred frequently after the remission and large tumor size was a poor prognostic factor. Further investigations are needed to improve the local control.
Carcinoma, Non-Small-Cell Lung* ; Chemoradiotherapy* ; Cisplatin ; Consolidation Chemotherapy ; Disease-Free Survival ; Drug Therapy ; Esophagitis ; Humans ; Neutropenia ; Paclitaxel* ; Pneumonia, Bacterial ; Radiotherapy ; Retrospective Studies ; Sepsis ; Survival Rate ; Treatment Failure ; Treatment Outcome*

BACKGROUND: This study compared the bronchodilator efficacy and safety of tiotropium inhalation capsules (18microgram once daily) with a ipratropium metered dose inhaler (2 puffs of 20microgram q.i.d.) in patients with chronic obstructive pulmonary disease (COPD). METHOD: After the initial screening assessment and a two-week run-in period, patients received either tiotropium 18microgram once daily or ipratropium 40microgram four times daily over a period of 4 weeks in a double blind, double dummy, parallel group study. The outcome measures were the lung function, the daily records of the peak expiratory flow rate (PEFR), the patients' questionnaire, and the use of concomitant salbutamol. The forced expiratory volume in one second (FEV1) and the forced vital capacity (FVC) were measured 5 minutes before inhalation, and 0.5, 1, 2 and 3 hours after inhaling the study drug on days 0, 14 and 28. RESULT: In 16 centers, 134 patients with a mean (SD) age of 66 (7) years and a predicted FEV1 of 42 (12)% were analyzed. The trough FEV1 response was significantly higher in the tiotropium group than in the ipratropium group after a four-week treatment period. The weekly mean morning PEFR of the tiotropium group was consistently higher than that of the ipratropium group during the 4-week treatment period with differences ranging from 12.52 to 13.88 l/min, which were statistically significant. Tiotropium was well tolerated by the COPD patients during the 4-week treatment period and had a similar safety profile to ipratropium. CONCLUSION: This study shows that tiotropium administrated once daily has a superior bronchodilator effect with a similar safety profile in treating COPD patients compared with ipratropium, inhaled four times daily.
Adult* ; Albuterol ; Bronchodilator Agents ; Capsules ; Forced Expiratory Volume ; Humans ; Inhalation ; Ipratropium* ; Lung ; Mass Screening ; Metered Dose Inhalers ; Outcome Assessment (Health Care) ; Peak Expiratory Flow Rate ; Pulmonary Disease, Chronic Obstructive* ; Surveys and Questionnaires ; Vital Capacity ; Tiotropium Bromide

PURPOSE: When used in the second-line setting, single- agent chemotherapy has produced response rates of more than 10% or median survival times greater than 4 months. We studied the safety and efficacy of using second-line single docetaxel (75 mg/m2) for advanced NSCLC patients who were previously treated with platinum-based chemotherapy in Korea. MATERIALS AND METHODS: Thirty-three patients with advanced NSCLC received chemotherapy from May 2002 to January 2005. We retrospectively reviewed the charts of these patients. The patients received 75 mg/m2 of doxetaxel on day 1 and this was repeated at 3-week intervals. RESULTS: The median age was 63 years (range: 42~77 years); 16 patients had adenocarcinoma and 8 patients had squamous cell carcinoma. The median number of cycles was 4 (range: 1~7 cycles). Of the 33 patients, 6 patients had partial responses, 13 patients had stable disease and 14 patients had progressive disease. The response rate was 18.2%. The median overall survival was 11 months (range: 7~15 months), and the median progression free survival was 5 months (range: 3~7 months). The median response duration was 5 months (range: 4~9 months). A total of 137 cycles were evaluated for toxicity. We observed grade 3 or 4 neutropenia in 79 cycles (57.6%), grade 3 or 4 leukopenia in 46 cycles (33.6%), and grade 3 febrile neutropenia in 2 cycles (1.5%). The median nadir day was day 9 (range: day 5~19), and the median number of G-CSF injections was 2 (range: 0~6). The most common non-hematologic toxicities were myalgia/arthralgia and neurotoxicity, but any grade 3 or 4 non-hematologic toxicity was not observed. The major toxicity of this therapy was neutropenia. The absolute neutrophil count decreased relatively rapidly, but neutropenic fever or related infection was rare. There were no treatment-related deaths. CONCLUSION: These results revealed a satisfactory response rate (18.2%) with using docetaxel as the second- line chemotherapy for NSCLC. The second-line docetaxel was an active and well-tolerated regimen in patients with advanced NSCLC pretreated with platinum-based chemotherapy.
Adenocarcinoma ; Carcinoma, Non-Small-Cell Lung* ; Carcinoma, Squamous Cell ; Disease-Free Survival ; Drug Therapy* ; Febrile Neutropenia ; Fever ; Granulocyte Colony-Stimulating Factor ; Humans ; Korea ; Leukopenia ; Neutropenia ; Neutrophils ; Retrospective Studies

PURPOSE: Increasing experimental evidence indicates that abnormal expression of c-kit may be implicated in the pathogenesis of a variety of solid tumors. It has been reported that over 70% of small cell lung cancer (SCLC) contain the c-kit receptor. In the present study, a c-kit analysis has been extended to non-small cell lung cancer (NSCLC). The expressions of p53, vascular endothelial growth factor (VEGF) and cd34, in addition to c-kit, were evaluated to investigate the correlations between these proteins and to determine their potential relationships with the clinicopathological data. MATERIALS AND METHODS: Paraffin-embedded tumor sections, obtained from 147 patients with NSCLC, were immunohistochemically investigated using anti-c-kit, anti- p53, anti-VEGF and anti-cd34 antibodies. RESULTS: c-kit was expressed in 40 (27%) of the tumors examined: 27% of the adenocarcinomas, 27% of the squamous cell carcinomas and 29% of the undifferentiated carcinomas. p53 and VEG F immunoreactivities were present in 107 (73%) and 110 (75%) carcinomas, respectively. Anti-cd34 was negative in all samples. No associations were established among these proteins. The c-kit, however, showed a strong correlation with the T factor: T1 (n=11), 0%; T2 (n=49), 16% and T3 (n=87), 37% (p=.006). CONCLUSION: It is suggested that in NSCLC c-kit is expressed relatively frequently and may become a therapeutic target for the patients with inoperable or recurrent c-kit positive tumors. The alterations in p53 probably constitute an early event, whereas the activated c-kit may contribute to tumor progression.
Adenocarcinoma ; Antibodies ; Carcinoma ; Carcinoma, Non-Small-Cell Lung ; Carcinoma, Squamous Cell ; Humans ; Immunohistochemistry ; Lung Neoplasms* ; Lung* ; Proto-Oncogene Proteins c-kit ; Small Cell Lung Carcinoma ; Vascular Endothelial Growth Factor A

OBJECTIVE: The measurement of liver size can be used for the diagnosis of the fetal growth abnormality (FGR, macrosomia etc.). The purpose of this study was to evaluate a mathematical relationship between the fetal liver size(liver length or volume) and the gestational age in the normal pregnancies. Brief comparisons were also tried on the base of the degree of the correlation between liver length and its volume. METHODS: We collected 54 singleton pregnancies of 20 to 36weeks of gestation for measuring fetal liver length and 57 singleton pregnancies for measuring fetal liver volume. We used Combison 530 utrasonic machine(Kreztechnik AG, Zipf, Austria). RESULTS: There was significant correlation between liver size( length and volume) and gestation age. And the liver volume better correlated with gestational age than liver length(r=0.93 : r=0.78, p<0.0001, p<0.0001). CONCLUSION: Ultrasonic measurement of fetal liver size is a reliable indicator of fetal growth, especially liver volume. Therefore these data may have a potential value for the prediction of abnormal fetal growth(FGR, macrosomia).
Diagnosis ; Fetal Development ; Gestational Age* ; Liver* ; Pregnancy* ; Ultrasonics