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Bioequivalence of Bucilin Tablet to Rimatil Tablet (Bucillamine 100 mg) (리마틸 정(부시라민 100 mg)에 대한 부시린 정의 생물학적 동등성)

  • Cho, Hea-Young;Lee, Moon-Seok;Oh, In-Joon;Kim, Dong-Hyun;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.31 no.2
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    • pp.125-130
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    • 2001
  • Bucillamine is a novel cysteine derivative with two free intramolecular sulfhydryl groups, and has a preventive and therapeutic effect on adjuvant arthritis, suggesting its antirheumatic action. With respect to the effect on the immune system, bucillamine-exerted such immunoregulating actions are to nomalize an excessive reduction or acceleration in immune reaction. It is useful not only in patients with early stage of rheumatoid arthritis (RA) but also in those with active RA retained for more than 10 years. The purpose of the present study was to evaluate the bioequivalence of two bucillamine tablets, $Rimatil^{TM}$ (Chong Kun Dang Pharmaceutical Co., Ltd.) and $Bucilin^{TM}$ (Kuhn Il Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, $23.67{\pm}2.09$ years in age and $65.03{\pm}6.73\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After three tablets containing 100 mg of bucillamine per tablet were orally administered, blood was taken at predetermined time intervals and the concentrations of bucillamine in serum were determined using GC/MS with mass selective detector. Pharmacokinetic parameters such as $AUC_t$, $C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t$, $C_{max}\;and\;T_{max}$ between two tablets were -0.29%, -3.20% and 8.22%, respectively, when calculated against the $Rimatil^{TM}$ tablet. The powers $(1-{\beta})$ for $AUC_t\;and\;C_{max}$ were 84.31 % and 91.16%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.10$ and $1-{\beta}=0.8$ were less than 20% (e.g., 18.58% and 16.51% for $AUC_t\;and\;C_{max}$, respectively). The 90% confidence intervals were within ${\pm}20%$ (e.g.,$-12.77{\sim}12.20$ for $AUC_t$ and $-14.30{\sim}7.90$ for $C_{max}$). Two parameters met the criteria of KFDA for bioequivalence, indicating that $Bucilin^{TM}$ tablet is bioequivalent to $Rimatil^{TM}$ tablet.

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Container BIC-code region extraction and recognition method using multiple thresholding (다중 이진화를 이용한 컨테이너 BIC 부호 영역 추출 및 인식 방법)

  • Song, Jae-wook;Jung, Na-ra;Kang, Hyun-soo
    • Journal of the Korea Institute of Information and Communication Engineering
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    • v.19 no.6
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    • pp.1462-1470
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    • 2015
  • The container BIC-code is a transport protocol for convenience in international shipping and combined transport environment. It is an identification code of a marine transport container which displays a wide variety of information including country's code. Recently, transportation through aircrafts and ships continues to rise. Thus fast and accurate processes are required in the ports to manage transportation. Accordingly, in this paper, we propose a BIC-code region extraction and recognition method using multiple thresholds. In the code recognition, applying a fixed threshold is not reasonable due to a variety of illumination conditions caused by change of weather, lightening, camera position, color of the container and so on. Thus, the proposed method selects the best recognition result at the final stage after applying multiple thresholds to recognition. For each threshold, we performs binarization, labeling, BIC-code pattern decision (horizontal or vertical pattern) by morphological close operation, and character separation from the BIC-code. Then, each characters is recognized by template matching. Finally we measure recognition confidence scores for all the thresholds and choose the best one. Experimental results show that the proposed method yields accurate recognition for the container BIC-code with robustness to illumination change.

A Case Study of Software Quality Improvement (소프트웨어의 품질개선을 위한 사례연구)

  • Jeong, Hyun-Seok;Hwang, In-Soo;Yang, Hae-Sool
    • The KIPS Transactions:PartD
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    • v.10D no.4
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    • pp.727-734
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    • 2003
  • Recently various quality assurance activities have been applied in software industry for the purpose of software qualify improvement, and the ultimate target of those activities are focused on removing defects from its developed applications. We declared "ZERO DEFECT 21" movement on March 1999 whose purpose is to deliver defect-free applications to the customer. In this paper we would like to introduce the followings $\circled1$ Approaching Methods, $\circled2$ Achievements of "ZERO DEFECT 21". After accomplishing first you of "ZERO DEFECT 21" movement which consist of Audits and Software inspections, we could get the following improvement . $\circled1$ due to conducting the "Audits," we could prevent 22 cases of customer claims, enhance 11.7% of design quality and improve 23.3% of deliverable reusability : $\circled2$ also, due to conducting the "Periodic Sampling inspection and Final inspection," we could enhance 123% of defect rate compared with early stage of development and 247% of defect rate compared with previous yew. Based on the survey results, we could conclude that "ZERO DEFECT 21 " movement provides confidence to project team members and reliability to our customers.ce to project team members and reliability to our customers.

Preliminary Evaluation of Clinical Utility of CYFRA 21-1, CA 72-4, NSE, CA19-9 and CEA in Stomach Cancer

  • Gwak, Hee Keun;Lee, Jai Hyuen;Park, Seok Gun
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.12
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    • pp.4933-4938
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    • 2014
  • Background: Although various tumor markers have been utilized in management of stomach cancer (SC), only a few reports have described relevance of examples such as CYFRA 21-1 and neuron-specific enolase (NSE). The purpose of this study was to evaluate the potential diagnostic performance of carcinoembryonic antigen (CEA), CA 19-9, CA72-4, CYFRA 21-1 and NSE in patients with SC. Materials and Methods: Ninety-six SC patients with pathologic confirmation between 2012 and 2013 were enrolled. Serum levels of five tumor markers were analyzed using a solid-phase immunoradiometric assay. Receiver operating characteristic (ROC) curves were plotted for the five tumor markers to investigate their diagnostic powers and adjusted cutoff values derived from analysis of ROC curves were evaluated to calculate the sensitivity of each for SC with recommended cutoff values. Results: Based on two different cutoff values (recommended and adjusted), CYFRA 21-1 (${\geq}2.0$ and 1.2 ng/ml) had a respective sensitivity of 50% and 78.1%, compared with 8.3% and 18.8% for CEA (${\geq}7.0$ and 3.9 ng/ml), 15.6% and 18.8% for CA 19-9 (${\geq}37$ and 26.7 ng/ml), 28.1% and 9.6% for CA 72-4 (${\geq}4.0$ and 13 ng/ml) and 7.3% and 7.3% for NSE (${\geq}14.7$ and 15.0 ng/ml) in the initial staging of primary SC. The area under the curve (AUC) for CYFRA 21-1, with a value of 0.978 (95% confidence interval, 0.964-0.991) was comparatively the highest. Univariate analysis revealed significant relationships between tumor marker level and lymph node involvement, metastasis and staging with CYFRA 21-1, CA 72-4 and NSE. Conclusions: CYFRA 21-1 was the most sensitive tumor marker and showed the most powerful diagnostic performance among the five SC tumor markers. NSE and CA 72-4 are significantly related to lymph node involvement, metastasis or stage. Further evaluations are warranted to clarify the clinical usefulness and prognostic prediction of these markers in SC.

Self-Efficacy and Self-Control Effects on Purchasing Intention of Annuity Savings Plans: Considering Financial Literacy (금융 유통산업에서의 자기효능감과 자기통제가 연금저축 가입의도와 가입행동에 미치는 영향: 금융이해력에 따른 차이분석)

  • Lee, Yun-Bok;Lee, Phil-Soo;Hwang, Jae-Kwang
    • Journal of Distribution Science
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    • v.13 no.11
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    • pp.69-77
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    • 2015
  • Purpose - Economic status at an early stage of life after one's retirement is often determined by the long-term sacrifice of one's earlier consumption tendencies. In general, the first and foremost way to secure income after retirement is through annuity savings. People sign up for personal annuity savings in order to guarantee a stable economic life upon retirement, and such actions may be heavily influenced by self-efficacy. Confidence in current economic activity is a source of rational decision-making. Inability to achieve self-control can lead to reckless spending and the eventual hindering of proper investment for the future. This paper examines how self-efficacy and self-control affect the intention and action of enrolling in an annuity savings plan in relation to one's level of financial literacy. Research design, data, and methodology - To analyze the proposed model, this study investigates financial consumers over the age of 20. The data were collected from 511 respondents and analyzed with SPSS 21.0 and AMOS 21.0. First, for the one-dimensional test and to measure the convergent validity of each structure, we use the scale purification process. The results of the test and the confirmatory factor analysis ensure the focus of the validity of the single dimension for each structure. In addition, the validity of the measurement was guaranteed from the results of correlation analysis. Results - First, self-efficacy and self-control have positive effects on the purchasing intention of the personal annuity savings plan. Second, purchasing intention positively affects purchasing behavior. Lastly, self-control has a positive effect on purchasing intention among the low financial literacy group, whereas self-efficacy does not have this effect in the high financial literacy one. Conclusions - The time of product benefit is different with age. The younger group would be granted the savings after several decades once they enroll, whereas the older group would wait for a relatively shorter period of time. Therefore, further research should be conducted in order to verify such a difference. However, this study has value through its confirmation that the roles of self-efficacy and self-control play a part in leading to the enrollment in annuity savings plans and by verifying different effects based on levels of financial literacy. Such results suggest a number of implications in a real life setting. First, banks need to put greater emphasis on the stability of annuity savings in general. Second, customers with relatively low levels of financial literacy are able to control their finances through annuity savings, but find self-efficacy difficult due to a lack of financial understanding. Therefore, such customers should be approached from an invest-effectiveness comparison method. Third, customers with high financial literacy tend to put more value in rational economic decision-making and behavior than in self-efficacy. Therefore, such customers should be approached by promoting the reliability of annuity savings and the excellence of the specific bank's annuity savings plan in comparison to those of other financial institutions.

Transcatheter arterial chemoembolization and radiation therapy for treatment-na$\ddot{i}$ve patients with locally advanced hepatocellular carcinoma

  • Kim, Sang Won;Oh, Dongryul;Park, Hee Chul;Lim, Do Hoon;Shin, Sung Wook;Cho, Sung Ki;Gwak, Geum-Youn;Choi, Moon Seok;Paik, Yong Han;Paik, Seung Woon
    • Radiation Oncology Journal
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    • v.32 no.1
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    • pp.14-22
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    • 2014
  • Purpose: To evaluate the safety and efficacy of transcatheter arterial chemoembolization (TACE) followed by radiotherapy (RT) in treatment-na$\ddot{i}$ve patients with locally advanced hepatocellular carcinoma (HCC). Materials and Methods: Eligibility criteria were as follows: newly diagnosed with HCC, the Barcelona Clinic Liver Cancer stage C, Child-Pugh class A or B, and no prior treatment for HCC. Patients with extrahepatic spread were excluded. A total of 59 patients were retrospectively enrolled. All patients were treated with TACE followed by RT. The time interval between TACE and RT was 2 weeks as per protocol. A median RT dose was 47.25 $Gy_{10}$ as the biologically effective dose using the ${\alpha}/{\beta}$ = 10 (range, 39 to 65.25 $Gy_{10}$). Results: At 1 month, complete response was obtained in 3 patients (5%), partial response in 27 patients (46%), stable disease in 13 patients (22%), and progressive disease in 16 patients (27%). The actuarial one- and two-year OS rates were 60.1% and 47.2%, respectively. The median OS was 17 months (95% confidence interval, 5.6 to 28.4 months). The median time to progression was 4 months (range, 1 to 35 months). Grade 3 or greater liver enzyme elevation occurred in only two patients (3%) after RT. Grade 3 gastroduodenal toxicity developed in two patients (3%). Conclusion: The combination treatment of TACE followed by RT with two-week interval was safe and it showed favorable outcomes in treatment-na$\ddot{i}$ve patients with locally advanced HCC. A prospective randomized trial is needed to validate these results.

Cost Estimation of Case-Based Reasoning Using Hybrid Genetic Algorithm - Focusing on Local Search Method Using Correlation Analysis - (혼합형 유전자 알고리즘을 적용한 사례기반추론 공사비예측 - 상관분석을 이용한 지역탐색 기법을 중심으로 -)

  • Jung, Sangsun;Park, Moonseo;Lee, Hyun-Soo;Yoon, Inseok
    • Korean Journal of Construction Engineering and Management
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    • v.21 no.1
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    • pp.50-60
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    • 2020
  • Estimates of project costs in the early stages of a construction project have a significant impact on the operator's decision-making in important matters, such as the site's decision or the construction period. However, it is difficult to carry out the initial stage with confidence because information such as design books and specifications is not available. In previous studies, case-based reasoning was used to predict initial construction costs, and genetic algorithms were used to calculate the weight of the inquiry phase among them. However, some say that it is difficult to perform better than the current year because existing genetic algorithms are calculated in random numbers. To overcome these limitations, correlation numbers using correlation analysis rather than random numbers are reflected in the genetic algorithm by method of local search, and weights are calculated using a hybrid genetic algorithm that combines local search and genetic algorithms. A case-based reasoning model was developed using the weights calculated and validated with the data. As a result, it was found that the hybrid GA-CBR applied with local search performed better than the existing GA-CBR.

Body Mass Index as a Predictor of Acute Kidney Injury in Critically Ill Patients: A Retrospective Single-Center Study

  • Ju, Sunmi;Lee, Tae Won;Yoo, Jung-Wan;Lee, Seung Jun;Cho, Yu Ji;Jeong, Yi Yeong;Lee, Jong Deog;Kim, Ju-young;Lee, Gi Dong;Kim, Ho Cheol
    • Tuberculosis and Respiratory Diseases
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    • v.81 no.4
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    • pp.311-318
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    • 2018
  • Background: The aim of this study was to examine the influence of body mass index (BMI) on the development of acute kidney injury (AKI) in critically ill patients in intensive care unit (ICU). Methods: Data of patients admitted to medical ICU from December 2011 to May 2014 were retrospectively analyzed. Patients were classified into three groups according to their BMI: underweight (< $18.5kg/m^2$), normal ($18.5-24.9kg/m^2$), and overweight (${\geq}25kg/m^2$). The incidence of AKI was compared among these groups and factors associated with the development of AKI were analyzed. AKI was defined according to the Risk, Injury, Failure, Loss of kidney function, and End-stage (RIFLE) kidney disease criteria. Results: A total of 468 patients were analyzed. Their mean BMI was $21.5{\pm}3.9kg/m^2$, including 102 (21.8%) underweight, 286 (61.1%) normal-weight, and 80 (17.1%) overweight patients. Overall, AKI occurred in 82 (17.5%) patients. The overweight group had significantly (p<0.001) higher incidence of AKI (36.3%) than the underweight (9.8%) or normal group (15.0%). In addition, BMI was significantly higher in patients with AKI than that in those without AKI ($23.4{\pm}4.2$ vs. $21.1{\pm}3.7$, p<0.001). Multivariate analysis showed that BMI was significantly associated with the development of AKI (odds ratio, 1.893; 95% confidence interval, 1.224-2.927). Conclusion: BMI may be associated with the development of AKI in critically ill patients.

Prognostic Factors and Clinical Outcome in Parotid Gland Tumors: a Single Institution Experience from the Eastern Black Sea Region of Turkey

  • Kandaz, Mustafa;Soydemir, Gulsen;Bahat, Zumrut;Canyilmaz, Emine;Yoney, Adnan
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.3
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    • pp.1169-1174
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    • 2016
  • Purpose: To review clinical characteristics, treatment outcomes and prognostic factors in patients with parotid gland tumors treated with surgery and postoperative radiotherapy. Materials and Methods: We retrospectively reviewed 69 patients with parotid gland tumors, with a median follow-up of 52 months (range, 2-228 months). and a median radiotherapy dose of 60Gy (range, 30-69 Gy). Results: There were 24 (35%) females and 45 (65%) males, at a ratio of 1/1.9. Median age at presentation was $58.9{\pm}17.2$ (range 13-88) years. The most common histology was adenoid cystic carcinoma (33%) and mucoepidermoid carcinoma (28%). The mean overall survival (OS) was $65.3{\pm}8$ (95% confidence interval [CI], 49.6-81.1) months and the median overall survival was $40.0{\pm}7$ (95% CI, 26.2-53.7) months. The -1, -3, -5 and -10 year OS rates were 78%, 52.4%, 35.3% and 19.6% respectively. The mean disease free survival (DFS) was $79.2{\pm}10$ (95% CI, 59.3-97.1) months and the median disease free survival was $38{\pm}13$ (95% CI, 7.05-88.7) months. The -1,-3,-5 and -10 year DFS rates were 71.9%, 50.1%, 43.7% and 30.1% respectively. On univariate analysis, the OS was significantly better with female sex (p<0.005), < 50 age (p<0.021), T stage (p<0.0001), absence of lymph node involvement (p<0.0001), lower tumor grade (p<0.0001), absence of lymphovascular invasion (p<0.002), absence of perineural invasion (p<0.0001), absence of extracapsuler extension (p<0.0001), surgical margin negativity (p<0.006), ${\leq}60Gy$ radiotherapy dose (p<0.0001) and absence of distant metastasis (p<0.027). Conclusions: Employing existing standards of postoperative radiotherapy is a possible treatment that was found to be mainly effective in patients with parotid gland carcinomas.

Human Epididymis Protein 4 Reference Intervals in a Multiethnic Asian Women Population

  • Mokhtar, N.M.;Thevarajah, M.;M.A., Noorazmi;M., Isahak
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.12
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    • pp.6391-6395
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    • 2012
  • Background: Ovarian cancer is ranked as the fifth most common cause of cancer death in women. In Malaysia, it is the fourth most common cancer in females. CA125 has been the tumor marker of choice in ovarian cancer but its diagnostic specificity in early stages is only 50%. Hence, there is a critical need to identify an alternative tumor marker that is capable of detecting detect ovarian cancer at an early stage. HE4 is a new tumor marker proposed for the early diagnosis of ovarian cancer and disease recurrence. Currently, none of the normal ranges of HE4 quoted in the literature are based on data for a multiethnic Asian population. Therefore, the aim of this study was to determine reference intervals for HE4 in an Asian population presenting in University Malaya Medical Centre, a tertiary reference hospital. Materials and Methods: 300 healthy women were recruited comprising 150 premenopausal and 150 postmenopausal women, aged from 20-76 years. All women were subjected to a pelvic ultrasonograph and were confirmed to be free from ovarian pathology on recruitment. Serum HE4 levels were determined by chemiluminescent microparticle immunoassay (CMIA, Abbott Architect). The reference intervals were determined following CLSI guidelines (C28-A2) using a non-parametric method. Results: The upper limits of the $95^{th}$ percentile reference interval (90%CI) for all the women collectively were 64.6 pmol/L, and 58.4 pmol/L for premenopausal) and 69.0 pmol/L for postmenopausal. The concentration of HE4 was noted to increase with age especially in women who were more than 50 years old. We also noted that our proposed reference limit was lower compared to the level given by manufacturer Abbott Architect HE4 kit insert (58.4 vs 70 pmol/L for premenopausal group and 69.0 vs 140 pmol/L in the postmenopausal group). The study also showed a significant difference in HE4 concentrations between ethnic groups (Malays and Indians). The levels of HE4 in Indians appeared higher than in Malays (p<0.05), while no significant differences were noted between the Malays and Chinese ethnic groups. Conclusions: More data are needed to establish a reference interval that will better represent the multiethnic Malaysian population. Probably a larger sampling size of equal representation of the Malay, Chinese, Indians as well as the other native ethnic communities will give us a greater confidence on whether genetics plays a role in reference interval determination.