BACKGROUND: Lamivudine and abacavir sulfate are widely used nucleoside/tide reverse transcriptase inhibitors (NRTI) backbone agents, which are recommended in major international treatment guidelines. The fixed-dose combination of lamivudine and abacavir sulfate has been developed to contribute to low pill burden of antiretroviral therapy (ART) regimen and patient adherence. A mandatory post-marketing surveillance was conducted in Korea to monitor the safety of Kivexa (lamivudine 300 mg/abacavir 600 mg). MATERIALS AND METHODS: An open label, multi-center, non-interventional post-marketing surveillance was conducted to monitor the safety of Kivexa from July 2011 to July 2017 in 23 hospitals in Korea. Subjects over 12 years old taking Kivexa per prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events during the study period. Secondary outcomes included the occurrence of adverse drug reaction, the occurrence of serious adverse events and the effectiveness of Kivexa. RESULTS: A total of 600 patients from 23 hospitals were enrolled within the 6 years of study. The total observation period was 1,004 person-years. Three hundred and ten patients reported 674 adverse events. The incidence of upper respiratory infection (65 cases, 10.9%) was the highest, followed by diarrhea (20 cases, 3.3%), and nausea (18 cases, 3.0%). 109 subjects reported 71 events of adverse drug reactions, and the most common reaction was nausea in 2.33% of the subjects. Thirty-one subjects reported serious adverse events, none of them were considered drug related. From the total of 600 subjects, excluding 48 subjects who were ‘effectiveness unassessable’ by investigators, 552 patients were eligible for the subjective effectiveness analysis. 459 (83.2%) were evaluated as ‘improved’. Proportion of subjects whose human immunodeficiency virus-RNA is <50 copies/ml was 61.2% (309/505) at the beginning of observation and increased to 91.9% (464/505) at the end of study period. CONCLUSIONS The post-marketing surveillance showed the safety of Kivexa in HIV-1 patients in Korea. Ischemic cardiovascular events and hypersensitivity associated with Kivexa were few. There was no significant new safety information. This data may be helpful in implementing Kivexa and lamivudine/abacavir sulfate containing drugs in Korea.

PURPOSE: Pentraxin 3 (PTX3) has been suggested to be a prognostic marker of mortality in severe sepsis. Currently, there are limited data on biomarkers including PTX3 that can be used to predict mortality in severe sepsis patients who have undergone successful initial resuscitation through early goal-directed therapy (EGDT). MATERIALS AND METHODS: A prospective cohort study was conducted among 83 severe sepsis patients with fulfillment of all EGDT components and the achievement of final goal. Plasma PTX3 levels were measured by sandwich ELISA on hospital day (HD) 0, 3, and 7. The data for procalcitonin, C-reactive protein and delta neutrophil index were collected by electric medical record. The primary outcome was 28-day all-cause mortality. RESULTS: 28-day all-cause mortality was 19.3% and the median (interquartile range) APHCH II score of total patients was 16 (13–19). The non-survivors (n=16) had significantly higher PTX3 level at HD 0 [201.4 (56.9–268.6) ng/mL vs. 36.5 (13.7–145.3) ng/mL, p=0.008]. PTX3 had largest AUC(ROC) value for the prediction of mortality among PTX3, procalcitonin, delta neutrophil index, CRP and APACHE II/SOFA sore at HD 0 [0.819, 95% confidence interval (CI) 0.677–0.961, p=0.008]. The most valid cut-off level of PTX3 at HD 0 was 140.28 ng/mL (sensitivity 66.7%, specificity 73.8%). The PTX3 and procalcitonin at HD 0 showed strong correlation (r=0.675, p<0.001). However, PTX3 at HD 0 was the only independent predictive marker in Cox's proportional hazards model (≥140 ng/mL; hazard rate 7.16, 95% CI 2.46–15.85, p=0.001). CONCLUSION: PTX3 at HD 0 could be a powerful predictive biomarker of 28-day all-cause mortality in severe septic patients who have undergone successful EGDT.
APACHE ; Biomarkers ; C-Reactive Protein ; Cohort Studies ; Enzyme-Linked Immunosorbent Assay ; Humans ; Medical Records ; Mortality* ; Neutrophils ; Plasma ; Proportional Hazards Models ; Prospective Studies ; Resuscitation ; Sensitivity and Specificity ; Sepsis

BACKGROUND: Abacavir is a widely-used nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) infection. Mandatory postmarketing surveillance was conducted in Korea to monitor the safety and evaluate the effectiveness of Ziagen® (abacavir sulfate 300 mg; ViiV Healthcare, Middlesex, UK). MATERIALS AND METHODS: An open-label, multi-center, non-interventional postmarketing surveillance study was conducted from June 2010 to June 2016 to monitor the safety and effectiveness of Ziagen across 12 hospitals in Korea. Subjects older than 18 years taking Ziagen according to prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events after Ziagen administration. Secondary outcomes included the occurrence of adverse drug reactions, occurrence of serious adverse events, and effectiveness of Ziagen administration. RESULTS: A total of 669 patients were enrolled in this study, with a total observation period of 1047.8 person-years. Of these, 90.7% of patients were male. The mean age of patients was 45.8±11.9 years. One-hundred ninety-six (29.3%) patients reported 315 adverse events, and four patients reported seven serious adverse events, without any fatal events. There was one potential case of an abacavir hypersensitivity reaction. Among the 97 adverse drug reactions that were reported from 75 patients, the most frequent adverse drug reactions included diarrhea (12 events), dyspepsia (10 events), and rash (9 events). No ischemic heart disease was observed. In the effectiveness analysis, 91% of patients achieved HIV-1 RNA under 50 copies/mL after 24 months of observation with abacavir administration. CONCLUSION: Our data showed the safety and effectiveness of Ziagen in a real-world setting. During the study period, Ziagen was well-tolerated, with one incident of a clinically suspected abacavir hypersensitivity reaction. The postmarketing surveillance of Ziagen did not highlight any new safety information. These data may be helpful in understanding abacavir and the HIV treatment practices in Korea.
Delivery of Health Care ; Diarrhea ; Drug-Related Side Effects and Adverse Reactions ; Dyspepsia ; Exanthema ; HIV ; HIV-1 ; Humans ; Hypersensitivity ; Korea ; Male ; Myocardial Ischemia ; Pharmacoepidemiology ; RNA ; RNA-Directed DNA Polymerase

BACKGROUND: Catheter-related exit site infection is a major risk factor for the development of peritonitis and can contribute to failure of treatment maintenance in peritoneal dialysis (PD) patients. Although povidone-iodine can be used for exit site care, the irritation induced by the local application of povidone-iodine could lead to secondary infection. Therefore, we evaluated the clinical effectiveness of normal saline compared with povidone-iodine as a method of exit site care in chronic PD patients. METHODS: In all, 126 patients undergoing PD treatment for>46 months between January 2006 and December 2009 were enrolled. Data were retrospectively analyzed for the incidence of exit site infection and peritonitis for 2 years prior to and after December 2007. In addition, we identified the incidences of catheter- related infections during follow-ups from January 2010 to December 2013. RESULTS: The participants' mean age was 58.87+/-12.9 years. The incidences of exit site infection and peritonitis were one episode per 64.6 patients-months and one episode per 40.4 patients-months in the povidone-iodine group, respectively, whereas these were one episode per 57.5 patients-months and one episode per 45.6 patients-months in the normal saline group, respectively. Whereas Gram-positive bacteria most frequently caused catheter-related infections in both groups, culture-negative infections were dominant in the normal saline group. CONCLUSION: Exit site care using normal saline did not increase the incidence of exit site infection and peritonitis. Therefore, normal saline may be an alternative treatment for exit site care in patients receiving PD.
Catheter-Related Infections ; Coinfection ; Follow-Up Studies ; Gram-Positive Bacteria ; Humans ; Incidence* ; Peritoneal Dialysis* ; Peritonitis* ; Povidone-Iodine* ; Retrospective Studies ; Risk Factors

BACKGROUND: Surgical site infection (SSI) is a potentially morbid and costly complication of surgery. While gastrointestinal surgery is relatively common in Korea, few studies have evaluated SSI in the context of gastric surgery. Thus, we performed a prospective cohort study to determine the incidence and risk factors of SSI in Korean patients undergoing gastric surgery. MATERIALS AND METHODS: A prospective cohort study of 2,091 patients who underwent gastric surgery was performed in 10 hospitals with more than 500 beds (nine tertiary hospitals and one secondary hospital). Patients were recruited from an SSI surveillance program between June 1, 2010, and August 31, 2011 and followed up for 1 month after the operation. The criteria used to define SSI and a patient's risk index category were established according to the Centers for Disease Control and Prevention and the National Nosocomial Infection Surveillance System. We collected demographic data and potential perioperative risk factors including type and duration of the operation and physical status score in patients who developed SSIs based on a previous study protocol. RESULTS: A total of 71 SSIs (3.3%) were identified, with hospital rates varying from 0.0 - 15.7%. The results of multivariate analyses indicated that prolonged operation time (P = 0.002), use of a razor for preoperative hair removal (P = 0.010), and absence of laminar flow in the operating room (P = 0.024) were independent risk factors for SSI after gastric surgery. CONCLUSIONS: Longer operation times, razor use, and absence of laminar flow in operating rooms were independently associated with significant increased SSI risk after gastric surgery.
Centers for Disease Control and Prevention (U.S.) ; Cohort Studies* ; Cross Infection ; Hair Removal ; Humans ; Incidence* ; Korea ; Multivariate Analysis ; Operating Rooms ; Prospective Studies* ; Risk Factors* ; Tertiary Care Centers

The purpose of this study was to investigate salinity and sodium content in foods served at industry foodservice operations in selected workplaces in Daegu. The researcher collected 1,142 food items categorized into 22 menu item groups from lunch samples served at 100 industry foodservice operations and measured the salinity of the food items, and calculated sodium and salt contents from the salinity. In terms of salt content of one meal at each workplace, 46% of the meals were 3-<5 g, and only 3.0% of them were 1.7 g or less, which is one third of the daily target intake (5 g) presented by the Dietary Reference Intakes for Koreans. In terms of sodium content, 35.3% of the meals were 1,000-< 1,500 mg (most), and only 2.5% of them were 667 mg or less, which is, again, one third of the daily target intake. As to the salinity of each menu item group, side dishes such as sauces, kimchi, seasoned vegetables, hard-boiled foods, and stir-fried foods were significantly higher, but the sodium content was not higher, because their quantity per serving was small. The salinity of foods with liquid such as stews, noodles, soups, and broths was relatively lower, but the sodium content was higher, because their quantity per serving was large. This indicates that an education program should be developed for foodservice workers who prepare food for the workplace regarding the development and promotion of various menus for reducing sodium content, in order to reduce sodium content in meals served by food service in the workplace.
Food Services ; Lunch ; Meals ; Salinity ; Seasons ; Sodium ; Vegetables

Bisphenol A (BPA) has been reported to possess hepatic toxicity. We investigated the hypothesis that BPA, below the no observed adverse effect level (NOAEL), can induce hepatic damage and mitochondrial dysfunction by increasing oxidative stress in the liver. Two doses of BPA, 0.05 and 1.2 mg/kg body weight/day, were administered intraperitoneally for 5 days to mice. Both treatments impaired the structure of the hepatic mitochondria, although oxygen consumption rate and expression of the respiratory complex decreased only at the higher dose. The hepatic levels of malondialdehyde (MDA), a naturally occurring product of lipid peroxidation, increased, while the expression of glutathione peroxidase 3 (GPx3) decreased, after BPA treatment. The expression levels of proinflammatory cytokines such as interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) also increased. In HepG2 cells, 10 or 100 nM of BPA also decreased the oxygen consumption rate, ATP production, and the mitochondrial membrane potential. In conclusion, doses of BPA below the NOAEL induce mitochondrial dysfunction in the liver, and this is associated with an increase in oxidative stress and inflammation.
Adenosine Triphosphate/metabolism ; Animals ; Glutathione Peroxidase/metabolism ; Hep G2 Cells ; Humans ; Inflammation/chemically induced/metabolism/pathology ; Injections, Intraperitoneal ; Interleukin-6/metabolism ; Lipid Peroxidation/drug effects ; Liver/*drug effects/metabolism/pathology ; Male ; Malondialdehyde/metabolism ; Membrane Potential, Mitochondrial/drug effects ; Mice ; Mice, Inbred C57BL ; Mitochondria/drug effects/*metabolism ; Oxidative Stress/drug effects ; Oxygen Consumption/drug effects ; Phenols/*toxicity ; Tumor Necrosis Factor-alpha/metabolism

Trace mineral studies involving metal ion chelators have been conducted in investigating the response of gene and protein expressions of certain cell lines but a few had really focused on how these metal ion chelators could affect the availability of important trace minerals such as Zn, Mn, Fe and Cu. The aim of the present study was to investigate the availability of Zn for the treatment of MC3T3-E1 osteoblast-like cells and the availability of some trace minerals in the cell culture media components after using chelexing resin in the FBS and the addition of N,N,N',N'-tetrakis-(2-pyridylmethyl)ethylenediamine (TPEN, membrane-permeable chelator) and diethylenetriaminepentaacetic acid (DTPA, membrane-impermeable chelator) in the treatment medium. Components for the preparation of cell culture medium and Zn-treated medium have been tested for Zn, Mn, Fe and Cu contents by atomic absorption spectrophotometer or inductively coupled plasma spectrophotometer. Also, the expression of bone-related genes (ALP, Runx2, PTH-R, ProCOL I, OPN and OC) was measured on the cellular Zn depletion such as chelexing or TPEN treatment. Results have shown that using the chelexing resin in FBS would significantly decrease the available Zn (p<0.05) (39.4 +/- 1.5 micrometer vs 0.61 +/- 10.15 micrometer) and Mn (p<0.05) (0.74 +/- 0.01 micrometer vs 0.12 +/- 0.04 micrometer). However, levels of Fe and Cu in FBS were not changed by chelexing FBS. The use of TPEN and DTPA as Zn-chelators did not show significant difference on the final concentration of Zn in the treatment medium (0, 3, 6, 9, 12 micrometer) except for in the addition of higher 15 micrometer ZnCl2 which showed a significant increase of Zn level in DTPA-chelated treatment medium. Results have shown that both chelators gave the same pattern for the expression of the five bone-related genes between Zn- and Zn+, and TPEN-treated experiments, compared to chelex-treated experiment, showed lower bone-related gene expression, which may imply that TPEN would be a stronger chelator than chelex resin. This study showed that TPEN would be a stronger chelator compared to DTPA or chelex resin and TPEN and chelex resin exerted cellular zinc depletion to be enough for cell study for Zn depletion.
Absorption ; Cell Culture Techniques ; Cell Line ; Chelating Agents* ; Gene Expression ; Minerals ; Osteoblasts* ; Pentetic Acid* ; Plasma ; Zinc

PURPOSE: The aim of this study was to investigate the causes of stridor with respiratory distress and their clinical courses in children. METHODS: Children who were hospitalized in Samsung Medical Center due to stridor with respiratory distress without infectious causes were studied retrospectively. The causes of stridor, sex, age at onset, symptoms, combined diseases, treatment, and clinical courses were investigated. Fisher's exact test was used to assessing the association of risk factors with the severity of post-intubation subglottic stenosis. RESULTS: Of 75 cases, 15 (20 percent) were congenital and 60 (80 percent) were acquired. The prevalence in males was higher than in females. Common causes of congenital stridor were laryngomalacia, tracheomalacia, pulmonary artery sling and complete tracheal ring. Acquired stridor is usually due to subglottic stenosis secondary to endotracheal intubation. Risk factors such as frequency and duration of intubation, age at first intubation, birth weight and gestational age were not associated with the developement of post-intubation subglottic stenosis. (P> 0.05) More complicated surgical treatment was required according to the severity of subglottic stenosis. CONCLUSION: Congenital malformation of the airway requiring urgent surgical correction should be differentiated in children with stridor and respiratory distress. Post-intubation subglottic stenosis accounts for most cases of acquired stridor. Evaluation of it's severity, and careful airway care, is required in children with subglottic stenosis.
Airway Obstruction ; Birth Weight ; Child* ; Constriction, Pathologic ; Female ; Gestational Age ; Humans ; Infant* ; Intubation ; Intubation, Intratracheal ; Laryngomalacia ; Male ; Prevalence ; Pulmonary Artery ; Respiratory Sounds* ; Retrospective Studies ; Risk Factors ; Tracheomalacia

OBJECTIVES: To determine changes in the incidence and pattern of eclampsia in Il Sin Christian Hospital over a 46-year period. METHODS: Information was collected from medical records of the 1910 eclamptic patients among 233,613 deliveries in Il Sin Christian Hospital from Jan. 1 1953 to Dec. 31 1998. Incidence, presentation, and management of eclampsia were reviewed retrospectively, and maternal mortality rate and perinatal mortality rate were calculated. Statistical analysis was done by Chi-squared and Fisher's exact test through two by two tables looking at relative changes between each study period. RESULTS: The overall incidence of eclampsia was 81.8 per 10,000 deliveries. The incidence of eclampsia had increased from 137.3/10,000 in 1953-1962 to 278.4/10,000 in 1963-1972, but the rate had reduced to 6.5/10,000 in 1993-1998. There was a statistically significant fall in the rate of eclampsia every decade between 1973 and 1992, but there has been steady decrease in the last study period. Convulsion occurred antepartum in 54% of patients, intrapartum in 29% and postpartum in 17%. With the reduction in the proportion of antepartum eclampsia, there has been a relative increase in that of intrapartum and postpartum eclampsia. Maternal death occurred in 59 cases among eclampsia, and maternal mortality rate was 3.1%. Maternal mortality rate had significantly decresed from 11.1% in 1953-1962 to 3.8% in 1963-1972, and there has been no maternal death from eclampsia since 1986. Postpartum eclampsia had increased death risk compared with antepartum or intrapartum eclampsia. There were 280 cases of perinatal death and overall perinatal mortality rate was 144.1 per 1000 deliveries. There was a significant decrease in the rate from 243.2/1000 in 1953-1962 to 141.5/1000 in 1963-1972, but the rate has risen steadily since 1983. CONCLUSIONS: With the improvement in antenatal care and management of eclampsia, the incidence of eclampsia and its associated maternal mortality has decreased over the last 46 years. But eclampsia still remains a significant complication of pregnancy with high maternal and perinatal mortality.
Eclampsia* ; Female ; Humans ; Incidence ; Maternal Death ; Maternal Mortality ; Medical Records ; Perinatal Mortality ; Postpartum Period ; Pregnancy ; Retrospective Studies ; Seizures