• Biomolecules & Therapeutics
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• v.6 no.4
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• pp.423-428
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• 1998

Aceclofenac is an orally effective non-steroidal anti-inflammatory agent of the phenylacetic acid derivative. Bioequivalence study of two aceclofenac preparations, the test drug (Senafe $n_{R}$: Daewon Phar-maceutical Company) and the reference drug (Airta $l_{R}$: Daewoong Pharmaceutical Company), was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers, 24$\pm$4 years old and 63.9$\pm$6.9 kg of body weight in average, were divided randomly into two groups and administered the drug orally at the dose of 100 mg as aceclofenac in a 2$\times$2 crossover study. Plasma concentrations of aceclofenac were monitored by HPLC method for 12 hr after administration. AU $Co_{-12h}$ (area under the plasma concentration-time curve from initial to 12 hr) was calculated by the linear trapezoidal method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{msx}$) were compiled directly from the plasma drug concentration-time data. Student's t-test indicated no significant differences between the formulations in these parameters. Analysis of variance (ANOVA) revealed that there are no differences in AU $Co_{12h}$, $C_{max}$ and $T_{max}$ between the formulations. The apparent differences between the formulations were far less than 20% (e.g., 0.25, 0.01 and 7.32 for AU $Co_{-12h}$, $C_{max}$. and $T_{max}$, respectively). Minimum detectable differences (%) between the formulations at $\alpha$=0.05 and 1-$\beta$=0.8 were less than 20% (e.g., 14.65, 12.47 and 15.46 for AU $Co_{-l2h}$, $C_{max}$ and $T_{max}$, respectively). The 90% confidence intervals for these parameters were also within $\pm$ 20% (e.g.,-10.19~10.68, -8.87~8.89 and -3.69~ 18.33 for AU $Co_{-12h}$, $C_{msx}$ and $T_{max}$, respectively). These results satisfy the bioequivalence criteria of KFDA guidelines, indicating that two formulations of aceclofenac are bioequivalent.quivalent.ivalent.ent.t.ent.

• Korean Journal of Clinical Pharmacy
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• v.16 no.1
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• pp.34-39
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• 2006

Fexofenadine, one of selective histamine $H_1$ receptor antagonists, has been used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The bioequivalence of two fexofenadine hydrochloride preparations, containing 120 mg fexofenadine hydrochloride, was evaluated according to the guidelines of Korea Food & Drug Administration(KFDA). The test product was Hanmi Fexofenadine Hydrochloride Tablet $120mg^{(R)}$ made by Hanmi Pharm. Co. and the reference product was Allegra Tablet $120mg^{(R)}$ made by Handok Parmaceuticals Co.. Twenty healthy male subjects were randomly divided into two groups and a $2{\times}2$ cross-over study was employed. After one tablet was orally administered, blood was taken at predetermined time intervals and the concentration of fexofenadine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t\;and\;C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t\;and\;C_{max}$ were log $0.844{\sim}log$ 1.149 and log $0.833{\sim}log$ 1.109, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Fexofenadine Hydrochloride Tablet 120 mg is bioequivalent to Allegra Tablet 120 mg.

• Research in Community and Public Health Nursing
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• v.26 no.3
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• pp.260-267
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• 2015

Purpose: This study aimed to examine the effectiveness of the workshop on the nurses' knowledge about urinary incontinence (UI) self-management, attitudes toward UI, and self-efficacy to plan and implement a UI self-help group program for their clients. Methods: A one-group pretest and posttest design was used to examine changes in knowledge, attitudes, and self-efficacy following a one-day training workshop. Twenty-seven community health nurses completed a questionnaire before and after the workshop. Before participating in the workshop, the participants were required to take a UI online continuing education program developed by the researchers. During the workshop, the participants took four sessions which consisted of an introduction of a self-help group program, demonstration of a 5-week UI self-management program contents, pelvic floor muscle training and biofeedback practice, and group discussions to plan the implementation in their workplaces. Results: A significant improvement in knowledge of and attitudes toward UI were found (t=3.53, p=.002; t=2.83, p=.009, respectively) after the workshop. Participants also demonstrated improvement in their self-efficacy to plan and operate a UI self-help group program (Z=-2.64, p=.008). Conclusion: The one-day workshop for community health nurses is a feasible strategy to increase their abilities and confidence in operating a UI self-help group program.

• Archives of Craniofacial Surgery
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• v.21 no.5
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• pp.294-300
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• 2020

Background: Mandibular fractures are one of the most common types of facial fractures, the treatment of which can be delayed due to the severity of the trauma resulting in an increase of complications; thus, early evaluation of trauma severity at the time of visit is important. In South Korea, trauma patients are triaged and intensively treated in designated regional trauma centers. This study aimed to analyze the relationship between trauma severity and mandibular fracture patterns. Methods: A medical records review was performed on patients who visited the regional trauma center at our hospital for mandibular fracture between 2009 and 2018. Epidemiologic data and mandibular fracture patterns were analyzed and compared with the conventional facial injury severity scale (FISS). Results: Among 73 patients, 51 were classified as non-severe trauma patients and 22 as severe trauma patients. A higher trauma severity was associated with older age (odds ratio [OR], 1.164; 95% confidence interval [CI], 1.057-1.404) and lower risk was associated with fractures located in the angle (OR, 0.001; 95% CI, 0-0.022), condylar process (OR, 0.001; 95% CI, 0-0.28), and coronoid process (OR, 0.004; 95% CI, 0-0.985). The risk was lower when the injury mechanism was a pedestrian traffic accident (OR, 0.004; 95% CI, 0-0.417) or fall (OR, 0.004; 95% CI, 0-0.663) compared with an in-car traffic accident. Higher FISS (OR, 1.503; 95% CI, 1.155-2.049) was associated with a higher trauma severity. The proposed model was found to predict the trauma severity better than the model using FISS (p< 0.001). Conclusion: Age, location of mandibular fractures, and injury mechanism showed significant relationships with the trauma severity. Epidemiologic data and patterns of mandibular fractures could predict the trauma severity better than FISS.

• Journal of Environmental Health Sciences
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• v.32 no.5 s.92
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• pp.424-430
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• 2006

Since 1985, the Gangwon Institute of Health and Environment(GIHE) and Ministry of Environment have collected rivers and streams water quality data in an ambient surface water monitering program. This study was prepared to propose an achievement of water quality of rivers subject to management by area according to an created level while establishing a water quality level applicable to the Gangwon area. As a result of evaluating correlativity on the BOD-based water quality data, BOD versus TP, and TP versus SS demonstrated significance at a confidence level of 95%. Evaluating correlativity on $10{\sim}90$ percentile values of analyzed data, a coefficient of determination, $r^{2}$ of BOD versus TP, and TP versus SS were 0.625, 0.286 respectively. Grading the results by evaluation method, the representative values of TP were 0.030 mg/l for I level, 0.100 mg/l for II level, 0.200 mg/l for Ill level, 0.300 mg/l for IV level, and 0.350 mg/l for V level, and those of SS were indicated 4.0 mg/l for I level, 15.0 mg/l for II level, 30.0 mg/l for III level, 45.0 mg/l for IV level, and 60.0 mg/l for V level. As for the limiting factor allowing the water quality standard exceeded, BOD posted 61% as the factor was found in 11 places, TP 28%, and SS 33%.

• The Journal of Korean Academic Society of Nursing Education
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• v.23 no.3
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• pp.279-289
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• 2017

Purpose: The purpose of this study is to investigate the learning experience, self-directed learning ability and self-efficacy of Japanese nursing students undergoing portfolio-based clinical practicums. Methods: The self-directed learning ability and self-efficacy of nursing students were examined using two scales. And using a text-mining approach, we constructed correspondence analysis followed by cluster analysis of open-ended responses forms. Results: The mean score of the self-directed learning ability was $60.89{\pm}5.28$ and the generalized self-efficacy was $68.37{\pm}11.56$. Moreover, the scores in the self-directed learning ability were positively correlated with scores in the generalized self-efficacy. In correspondence analysis, the distribution of extracted words showed that record was located on the negative side of the third quadrant, to the first principal component and that patient was located on the positive side of the first quadrant, contributing greatly to the second principal component. Conclusion: The results of this study contribute to approaching to "confidence, pride, stability," "growth and intention to development'' offers a key in developing self-directed learning ability. Students record what they see and learn the importance of visualizing it in learning portfolios. "Expression in detail of the learned contents" and "concerning to which objective evaluation is suggested" are important to the students.

• Asian Pacific Journal of Cancer Prevention
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• v.16 no.14
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• pp.5755-5762
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• 2015

Background: Short-course preoperative radiation (SCRT) with delayed surgery was found to increase pathologic complete response (pCR) rates in several trials. However, there was no clear answer on whether SCRT or long-course chemo-radiotherapy (LCRT) is more effective. Therefore we conducted this meta-analysis to evaluate the safety and efficacy of SCRT versus LCRT, both with delayed surgery, for treatment of rectal cancer. Materials and Methods: The literature was searched from PubMed, EMBASE, Web of Science, Cochrane Library and clinicaltrials.gov up to November, 2014. Quality of the randomized controlled trials (RCTs) was evaluated according to the Cochrane's risk of bias tool of RCT. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to rate the level of evidence. Review Manager 5.3 was employed for statistical analysis. Pooled risk ratios (RRs) and 95% confidence intervals (CIs) were calculated. Results: Three RCTs, with a total of 357 rectal cancer patients, were included in this systematic review. Metaanalysis results demonstrated there were no significantly differences in sphincter preservation rate, local recurrence rate, grade 3~4 acute toxicity, R0 resection rate and downstaging rate. Compared with SCRT, LCRT was associated with significant increase in the pCR rate [RR=0.49, 95%CI (0.31, 0.78), P=0.003]. Conclusions: In terms of sphincter preservation rate, local recurrence rate, grade 3~4 acute toxicity, R0 resection rate and downstaging rate, SCRT with delayed surgery is as effective as LCRT with delayed surgery for management of rectal cancer. LCRT significantly increased pCR rate compared with SCRT. Due to risk of bias and imprecision, further multi-center large sample RCTs were needed to confirm this conclusion.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.2
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• pp.1023-1029
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• 2014

Background: The purpose of our study was to elucidate the joint effects of combined smoking and alcohol intake on esophageal cancer mortality in Japanese men through a large cohort study with a 20-year follow-up period. Materials and Methods: The Japan Collaborative Cohort Study for Evaluation of Cancer Risk (JACC Study) was established in the late 1980s, including 46,395 men and 64,190 women aged 40 years and older and younger than 80. Follow-up of these participants was conducted until 2009. We used the Cox proportional hazards model to analyze data for 42,408 people excluding female participants, 411 people with histories of malignant neoplasms, and 3,576 with unclear smoking and drinking data. Results: The joint effects of age at start of smoking and amount of alcohol consumed per day were compared with non-smokers and non-drinkers or those consuming less than one unit of alcohol per day. The mortality risk was 9.33 (95% confidence interval, 2.55-34.2) for those who started smoking between ages 10 and 19 years and drinking at least three units of alcohol per day. Regarding the joint effects of cumulative amount of smoking and alcohol intake, the risk was high when both smoking and alcohol intake were above a certain level. Conclusions: In this Japanese cohort study, increased cancer mortality risks were observed, especially for people who both started smoking early and drank alcohol. Quitting smoking or not starting to smoke at any age and reducing alcohol consumption are important for preventing esophageal cancer in Japan.

• Journal of Korean Neurosurgical Society
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• v.51 no.1
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• pp.24-30
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• 2012

Objective : This study was conducted to assess the clinical significance of traumatic brain stem injury (TBSI) reflected on Glasgow Coma Score (GCS) and Glasgow Outcome Score (GOS) by various clinical variables. Methods : A total of 136 TBSI patients were selected out of 2695 head-injured patients. All initial computerized tomography and/or magnetic resonance imaging studies were retrospectively analyzed according to demographic- and injury variables which result in GCS and GOS. Results : In univariate analysis, mode of injury showed a significant effect on combined injury (p<0.001), as were the cases with skull fracture on radiologic finding (p<0.000). The GCS showed a various correlation with radiologic finding (p<0.000), mode of injury (p<0.002), but less favorably with impact site (p<0.052), age (p<0.054) and skull fracture (p<0.057), in order of statistical significances. However, only GOS showed a definite correlation to radiologic finding (p<0.000). In multivariate analysis, the individual variables to enhance an unfavorable effect on GCS were radiologic finding [odds ratio (OR) 7.327, 95% confidence interval (CI)], mode of injury (OR; 4.499, 95% CI) and age (OR; 3.141, 95% CI). Those which influence an unfavorable effect on GOS were radiologic finding (OR; 25.420, 95% CI) and age (OR; 2.674, 95% CI). Conclusion : In evaluation of TBSI on outcome, the variables such as radiological finding, mode of injury, and age were revealed as three important ones to have an unfavorable effect on early stage outcome expressed as GCS. However, mode of injury was shown not to have an unfavorable effect on late stage outcome as GOS. Among all unfavorable variables, radiological finding was confirmed as the only powerful prognostic variable both on GCS and GOS.

• Korean Journal of Biological Psychiatry
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• v.21 no.2
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• pp.74-80
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• 2014

Objectives More than half of the elders suffer from chronic sleep disturbances. Moreover, sleep disturbances are more prevalent in patients with depressive disorder than in community dwelling elderly. In this study, we aim to estimate the risk factors of poor sleep quality and its effect on quality of life in patients with late life depression. Methods This study included 159 depressive patients aged 65 years or older who completed Pittsburgh Sleep Quality Index (PSQI). A global PSQI score of 5 or greater indicates a poor sleeper. Structural diagnostic interviews were performed using the Korean version of Mini International Neuropsychiatric Interview (MINI). Depression was evaluated by the Korean form of Geriatric Depression Scale (KGDS). Global cognition was assessed by Mini-Mental State Examination in the Korean version of the Consortium to Establish a Registry for Alzheimer's Disease assessment packet. Quality of life was evaluated by the Korean version of Short-Form 36-Item Health Survey (SF-36). Results The frequencies of poor sleepers were 90.5% in major depressive disorder, 71.8% in minor depressive disorder, 47.1% in subsyndromal depressive disorder, and 73.0% in all types of depressive disorders. Multivariate logistic regression analysis indicated that female [odds ratio (OR) = 2.83, 95% confidence interval (CI) = 1.20-6.67] and higher KGDS score (OR = 1.13, 95% CI = 1.05-1.21) were risk factors of poor sleep quality in patients with late life depression. In the analysis of ANCOVA adjusted for age, gender, education and KGDS score, the mean scores of vitality mental health and mental component summary of SF-36 were lower in poor sleepers than in good sleepers. Conclusions Poor sleepers among patients with late life depression are very common and are associated with female and higher KGDS scores. Poor sleep quality causes a significant negative effect on mental health quality. So researchers and clinicians should be more vigilant in the evaluation and treatment of sleep disturbances in patients with late life depression.