PURPOSE: To evaluate the efficacy and safety of BOTULAX® in subjects with essential blepharospasm.METHODS: In this study, a total of 250 subjects with essential blepharospasm were enrolled at 15 investigational sites and a total of 220 subjects completed the study. The efficacy and safety were evaluated at weeks 4 and 16 after treatment compared with baseline. In total, 240 subjects were enrolled, treated with the investigational product, and evaluable for the primary efficacy assessment at week 4 after treatment; these subjects were included in the intention-to-treat (ITT) population. With the ITT set as the main efficacy set, efficacy assessment included Jankovic rating scale (JRS), functional disability score, investigator evaluation of global response and quality of life. Safety assessment including the incidence of adverse events was also performed.RESULTS: In terms of the primary efficacy endpoint (i.e., change in JRS total score at week 4 after treatment from baseline [ITT set]), mean change indicated a statistically significant reduction (p < 0.0001) and demonstrated the non-inferiority of the test drug to similar drugs. In terms of the secondary efficacy endpoints, mean change in JRS total score at week 16 after treatment and mean change in functional disability score at weeks 4 and 16 after treatment both exhibited a statistically significant reduction compared with baseline (p < 0.0001 for all). Among the 249 subjects treated with the investigational product in this study, 44 (17.67%) experienced 76 treatment emergent adverse events but no serious adverse events were observed.CONCLUSIONS: Based on the study results, BOTULAX® is considered to be an effective and safe treatment for essential blepharospasm.

Purpose: Acute respiratory distress syndrome (ARDS) is characterized by its acute onset of symptoms such as bilateral pulmonary infiltrates, severe hypoxemia, and pulmonary edema. Many patients with ARDS survive in the acute phase, but then die from significant lung fibrosis. Methods: The effect of combination therapy with polydeoxyribonucleotide (PDRN) and pirfenidone on ARDS was investigated using human lung epithelial A549 cells. ARDS environment was induced by treatment with lipopolysaccharide and transforming growth factor (TGF)-β. Enzyme-linked immunoassay for connective tissue growth factor (CTGF) and hydroxyproline were conducted. Western blot for collagen type I, fibroblast growth factor (FGF), tumor necrosis factor (TNF)-α, and interleukin (IL)-6 was performed. Results: In this study, 8-μg/mL PDRN enhanced cell viability. Combination therapy with PDRN and pirfenidone and pirfenidone monotherapy suppressed expressions of CTGF and hydroxyproline and inhibited expressions of collagen type I and FGF. Combination therapy with PDRN and pirfenidone and PDRN monotherapy suppressed expression of TNF-α and IL-1β. Conclusions The combination therapy with PDRN and pirfenidone exerted stronger therapeutic effect against lipopolysaccharide and TGF-β-induced ARDS environment compared to the PDRN monotherapy or pirfenidone monotherapy. The excellent therapeutic effect of combination therapy with PDRN and pirfenidone on ARDS was shown by promoting the rapid anti-inflammatory effect and inhibiting the fibrotic processes.

BACKGROUND: Hepatitis B virus (HBV) infection leads to hepatic and extrahepatic manifestations including chronic kidney disease (CKD). However, the association between HBV and CKD is not clear. This study investigated the association between chronic HBV infection and CKD in a nationwide multicenter study. METHODS: A total of 265,086 subjects who underwent health-check examinations in 33 hospitals from January 2015 to December 2015 were enrolled. HBV surface antigen (HBsAg) positive cases (n = 10,048), and age- and gender-matched HBsAg negative controls (n = 40,192) were identified. CKD was defined as a glomerular filtration rate (GFR) < 60 mL/min/1.73 m² or proteinuria as at least grade 2+ of urine protein. RESULTS: HBsAg positive cases showed a significantly higher prevalence of GFR < 60 mL/min/1.73 m² (3.3%), and proteinuria (18.9%) than that of the controls (2.6%, P < 0.001, and 14.1%, P < 0.001, respectively). In the multivariate analysis, HBsAg positivity was an independent factor associated with GFR < 60 mL/min/1.73 m² along with age, blood levels of albumin, bilirubin, anemia, and hemoglobin A1c (HbA1c). Likewise, HBsAg positivity was an independent factor for proteinuria along with age, male, blood levels of bilirubin, protein, albumin, and HbA1c. A subgroup analysis showed that HBsAg positive men but not women had a significantly increased risk for GFR < 60 mL/min/1.73 m². CONCLUSION: Chronic HBV infection was significantly associated with a GFR < 60 mL/min/1.73 m² and proteinuria (≥ 2+). Therefore, clinical concern about CKD in chronic HBV infected patients, especially in male, is warranted.
Anemia ; Antigens, Surface ; Bilirubin ; Case-Control Studies* ; Female ; Glomerular Filtration Rate ; Hepatitis B Surface Antigens ; Hepatitis B virus ; Hepatitis B, Chronic* ; Hepatitis, Chronic* ; Humans ; Male ; Multivariate Analysis ; Prevalence ; Proteinuria ; Renal Insufficiency, Chronic*

PURPOSE: This study was conducted to develop a nursing leadership program outcome evaluation system, required for accreditation of nursing education. METHODS: A methodological design was used. To ensure the theoretical validity of the evaluation system, learning objectives for nursing education programs and job descriptions for nurses in Korea were verified by analyzing the relationships in the five attributes of the nursing leadership concept. The nursing leadership program outcome evaluation system was developed based on the Kim & Park's developmental model (2008). RESULTS: The nursing leadership program outcome evaluation system was established, including implementation level, education curriculum, level of performance, evaluation method, rubrics, and Close-the-Loop. CONCLUSION: The developed evaluation system can be actively used in nursing education, and contribute to enhancing the leadership competencies of nursing students and graduate nurses.
Accreditation ; Curriculum ; Education ; Education, Nursing ; Humans ; Job Description ; Korea ; Leadership* ; Learning ; Methods ; Nursing* ; Students, Nursing

BACKGROUND: In Korea, the prevalence, complications, and mortality rate of diabetes are rapidly increasing. However, investigations on the actual condition of diabetes management are very limited due to lack of nation-wide research or multicenter study. Hence, we have minutely inquired the current status of diabetes management and achievement of glucose target goal in general hospital offering education program. That way, we are able to furnish data for policy making of diabetes education and draw up guideline which may allow us to reduce the morbidity and mortality of diabetes. METHODS: The subjects consisted of 2,610 patients with type 2 diabetes who visited the 13 general hospital in Seoul or Gyeonggi region from March 19 to May 29, 2013. General characteristics, associated diseases, complications, and management status were investigated. RESULTS: The mean age was 61.0+/-11.6 years, body mass index was 25.0+/-3.3 kg/m2, and family history of diabetes was 50.5%. The mean duration of diabetes was 10.7+/-7.9 years and 53% received education about diabetes. The prevalence of hypertension and dyslipidemia were 59.2% and 65.5%, respectively, and 18.3% of the subjects were accompanied by liver disease. Diabetic retinopathy appeared in 31.6%, nephropathy in 28.1%, and neuropathy in 19.9% of the subjects. The mean glycosylated hemoglobin (HbA1c) level was 7.3%+/-1.3% and the achieving rate based on Korean Diabetes Association guideline (HbA1c <6.5%) was 24.8%, blood pressure (130/80 mm Hg or less) was 49.4%, and low density lipoprotein cholesterol (<100 mg/dL) was 63.6%. The reaching rate to the target level in four parameters (blood glucose, blood pressure, lipids, and body weight) was 7.8%. CONCLUSION: The blood glucose control rate was lower than other parameters, and the implementation rate of diabetes education was only 53%. Thus more appropriate glucose control and systematic diabetes education are imperative.
Blood Glucose ; Blood Pressure ; Body Mass Index ; Cholesterol, LDL ; Diabetes Mellitus, Type 2* ; Diabetic Retinopathy ; Dyslipidemias ; Education ; Glucose ; Gyeonggi-do ; Hemoglobin A, Glycosylated ; Hospitals, General* ; Humans ; Hypertension ; Korea* ; Liver Diseases ; Mortality ; Policy Making ; Prevalence ; Seoul

PURPOSE: The purpose of this study was to provide a concept analysis of nursing leadership. METHODS: The concept analysis process of Walker and Avant (2011) was used. A review of the literature was conducted using several databases, including PubMed, CINAHL, Ovid-Medline, DBpia, and KISS. The databases were searched using the following terms 'nursing leadership', 'nursing' & 'leadership', and 'nurse & 'leadership', and for studies published from January 2000 to March 2015. Strict inclusion and exclusion criteria were applied. RESULTS: Analysis of these studies indicated nursing leadership attributes were individual growth, collaboration, nursing excellence, creative problem solving, and influence. The antecedents of nursing leadership were the individual maturity level, construction of mutual trust and confidential relationships, and a job requirement. The consequences were improvement in nursing productivity, development of a supportive work environment, and satisfaction with the nursing profession. CONCLUSION: The findings in this study provide a definite concept of nursing leadership. The findings also provide the theoretical evidence for the development of nursing leadership competencies in nursing students and professional nurses.
Cooperative Behavior ; Efficiency ; Humans ; Leadership* ; Nursing* ; Problem Solving ; Students, Nursing ; Walkers

PURPOSE: The purpose of this study was to identify the major trends in research studies in the Journal of Korean Academy of Nursing Administration from 2010 to 2012. METHODS: A review using analysis criteria developed by researchers was done of 132 studies published between 2010 and 2012. Research design, participants, research domain, and keywords were analyzed from the Journal of Korean Nursing Administration. RESULTS: Job satisfaction, stress, organizational commitment, safety, turnover, nursing education, and performance were found to be major keywords. Of the research in the Journal, quantitative methods were used in 93.2% of studies. The major setting and participants were hospitals (58.2%) and nurses (65.5%) respectively. Prevalent analysis methods used were t-test, ANOVA, correlation, regression, chi-square, AMOS, and factor analysis. Major domains in the articles were: controlling, directing, staffing, nursing management education, and professionalism & legal principles. CONCLUSION: Through this study, the research trends in nursing administration were identified, but there is a need to include more of the following topics in future research: new concepts in nursing policy, enhanced deliberations of IRB, rationalization of the effects in sample size calculations, theoretical development of planning and organizing, and development of interventions for management support of the nursing management process.
Education ; Education, Nursing ; Ethics Committees, Research ; Job Satisfaction ; Methods ; Nursing Research ; Nursing* ; Rationalization ; Research Design ; Sample Size

BACKGROUND AND OBJECTIVES: The purpose of this study was to analyze clinical safety of PMR(Palatal Muscle Resection) in obstructive sleep apnea patients. MATERIALS AND METHODS: Fourteen Patients underwent only PMR were reviewed retrospectively. ESS(Epworth Sleepiness Scale) was analyzed after PMR surgery to assess surgical results. Visual Analogue Scale were reviewed to evaluate postoperative pain. Eustachian tube function test, voice analysis, and measurement of forced expiration power were done after two months of surgery. RESULTS: ESS were improved after PMR. There were little postoperative pain. There was no significant change is observed vowel sounds except /u/ nor postoperative nasalization in voice, Eustachian tube dysfunction and change of expiration power. CONCLUSION: PMR may be regarded clinically safe surgery in obstructive sleep apnea patient.
Eustachian Tube ; Humans ; Muscles ; Pain, Postoperative ; Palate ; Phonation ; Retrospective Studies ; Sleep Apnea Syndromes ; Sleep Apnea, Obstructive ; Voice

PURPOSE: In autumn 2009, the swine-origin influenza A (H1N1) virus spread throughout South Korea. The aims of this study were to determine the clinical characteristics of children infected by the 2009 H1N1 influenza A virus, and to compare the rapid antigen and real-time polymerase chain reaction (PCR) tests. METHODS: We conducted a retrospective review of patients > or =18 years of age who presented to Soonchunhyang University Hospital in Seoul with respiratory symptoms, including fever, between September 2009 and January 2010. A real-time PCR test was used to definitively diagnose 2009 H1N1 influenza A infection. Medical records of confirmed cases were reviewed for sex, age, and the time of infection. The decision to perform rapid antigen testing was not influenced by clinical conditions, but by individual factors such as economic conditions. Its sensitivity and specificity were evaluated compared to real-time PCR test results. RESULTS: In total, 934 patients tested positive for H1N1 by real-time PCR. The highest number of patients (48.9%) was diagnosed in November. Most patients (48.2%) were aged between 6 and 10 years. Compared with the H1N1 real-time PCR test results, the rapid antigen test showed 22% sensitivity and 83% specificity. Seventy-eight patients were hospitalized for H1N1 influenza A virus infection, and fever was the most common symptom (97.4%). CONCLUSION: For diagnosis of 2009 H1N1 influenza A virus infection, the rapid antigen test was inferior to the real-time PCR test in both sensitivity and specificity. This outcome suggests that the rapid antigen test is inappropriate for screening.
Aged ; Child ; Fever ; Humans ; Influenza A virus ; Influenza, Human ; Mass Screening ; Medical Records ; Pandemics ; Polymerase Chain Reaction ; Real-Time Polymerase Chain Reaction ; Republic of Korea ; Retrospective Studies ; Sensitivity and Specificity ; Viruses

Synovial fluid (SF) aspiration cytology is a useful diagnostic tool. For patients with gouty arthritis, the diagnosis is confirmed by the presence of monosodium uric acid (MSU) crystals in the SF, and these crystals are long, pointed ended and needle-shaped and they show strongly negative birefringence. Sometimes, it is difficult to diagnosis between gouty arthritis and other type of inflammatory arthritis. We experienced two unusual cases of gouty arthritis that we performed SF analysis for. The first patient was a 35 year old male who presented with relatively typical clinical symptoms with hyperuricemia, but the SF showed acute inflammatory cells without crystals on light microscopy. Only a few suspected crystals of MSU were identified on polarizing microscopy. The second patient was a 45 year old male who presented with atypical symptoms and pain and swelling of the left ankle and knee joint for 3 weeks. The uric acid level in the serum and urine was increased, but not over the normal limit. However, on light and polarizing microscopy, there were numerous MSU crystals in the SF. Conclusively, in some cases of gouty arthritis, the crystals are not identified on light microscopy or the uric acid level is not dramatically increased. So, the polarizing microscopy, the clinical information and the laboratory findings are all included in the work-up when evaluating the SF cytology of arthritis patients.
Animals ; Ankle ; Arthritis ; Arthritis, Gouty ; Birefringence ; Gout ; Humans ; Hyperuricemia ; Knee Joint ; Light ; Male ; Microscopy ; Synovial Fluid ; Uric Acid