• Journal of The Korean Society of Inherited Metabolic disease
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• v.16 no.1
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• pp.18-23
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• 2016

Objective: Newborn screening leads to improved treatment and disease outcomes, but false-positive newborn screening results may impact include parental stress and anxiety, perception of child as unhealthy, parent-child relationship dysfunction, and increased infant hospitalizations. The purpose of this study was to investigate of the false positive rates and the causative factors of false positive results in Tandem Mass Spectrometry (TMS) in single center. Methods: Records were reviewed for all 18,872 subjects who were born in Cheill General Hospital, during January 1st, 2012 to December 31st, 2014. 17,292 neonates (91.62%) were tested for tandem mass screening almost in 2-5th day of life. Newborn babies whose first results were abnormal had been tested repeatedly by same methods in 7-14 day. If the results were abnormal again, further evaluation was performed. TMS analysis included data for the 43 disorders screened for using TMS broken down into three categories: fatty acid oxidation disorders, organic acidurias, and aminoacidopathies. The impact of several factors on increased false positive rates was analyzed using a multivariate analysis: time from birth to sample collection, birth weight, birth height, BMI, gender, gestational age, delivery type. Results: Males of the subjects were 8942 (51.7%), female 8350 (48.3%), the mean gestational age was $38.6{\pm}1.7$ weeks, the average birth weight $3,155.6{\pm}502.4g$, the average birth height $49.1{\pm}2.9cm$, and the average BMI $13.0{\pm}3.8(kg/m^2)$. Vaginal delivery cases were 9713 (56.2%), caesarean section 7,579 (43.8%). The average date of the inspection was $2.8{\pm}1.1$ days. 224 cases were identified as TMS positive. All the subjects were false positive (222/17,292, 1.30%) except 2 cases (1 male; benign phenylketonuria and 1 female; Short chain acyl-CoA dehydrogenase deficiency). The false positive rates were 0.61% in fatty acid oxidation disorders, 0.25% in organic acidurias, and 0.45% in aminoacidopathies. In our study, the date of inspection got late, the false positive rates got higher. Because almost the cases of late test date were in treatment in neonatal intensive care unit so their test date was affected by their medical conditions. False positive rate was higher in extreme immaturity${\leq}27$ weeks than newborns of gestational age >27 weeks [OR=6.957 (CI=1.273-38.008), p<0.025] and extremely low birth weight<1,000 g than newborns of birthweight ${\geq}1,000g$ [OR=5.616 (CI=1.134-27.820), p<0.035]. Conclusion: False positive rate of TMS was 1.30% in Cheil General Hospital. Lower gestational age and birth weight impacted on increased false positive rates. Better understanding of factors that influence the reporting of screening tests, and the ability to modify these important factors, may improve the screening process and reduce the need for retesting. of screening tests, and the ability to modify these important factors, may improve the screening process and reduce the need for retesting.

• The Korean Journal of Nuclear Medicine Technology
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• v.16 no.2
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• pp.149-155
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• 2012

Purpose : Serum insulin levels are useful indicator which of reflecting the function of insulin secretion in pancreatic ${\beta}$ cell and diagnosis of diabetes, differentiating the cause of impaired glucose tolerance. Insulin measurement kits have shown some differences in many ways such as test methods as well as quality control. The purpose of this study was to evaluate the diagnostic performance of seven manufacturing companies commercial kits. Materials and Methods : The values of insulin measured by three manufacturing companies (Biosource, Siemens, TFB) with 59 samples in August 2009 were compared with those measured by four manufacturing companies (Immunotech, Izotope, BNIBT, Cisbio) with 68 samples in December 2011. We evaluated precision, recovery rate, dilution test and correlation of serum insulin measurement using seven manufacturing company kits. Statistical program SPSS 12.0 was used for the verification of results. Results : The coefficients variation of the precision on all seven different kits were showed within 5.0%. Recovery rate of Biosource, Siemens, TFB kits on three different levels showed 94.2~103.7%, 99.0~104.6%, 99.7~107.6% respectively. Immunotech, Izotope, BNIBT, Cisbio were 93.5~99.1%, 91.4~99.1%, 99.2~131.0%, 84.8~102.3% respectively. There was strong correlation between the measurement of insulin by Biosource kit and that by two commercial kits, Siemens (R2=0.96), TFB (R2=0.99). There was good correlation between the measurement of insulin by TFB kit and that by three commercial kits, Immunotech (R2=0.97), Izotope (R2=0.96), Cisbio (R2=0.97). In the dilution test performed with more than 200 ${\mu}IU/ml$ high concentration samples, samples with diabetes correctly was measured in all seven manufacturing kits. However, as measured with insulinoma samples TFB, Siemens, Izotope, Cisbio kits were correctly measured, but Biosource and Immunotech kits were measured 47.4 ${\mu}IU/ml$, 72.3 ${\mu}IU/ml$, respectively. Conclusion : Serum Insulin radioimmunoassay kits were showed excellent precision, correlation and good recovery rate. However, some kits were not measured correctly in the high concentration insulin values. when selecting a kit should be considered many factors that cost effectiveness, compatible for automation equipment, high performance kit, the environment for each laboratory such as reaction time and reporting time.

• The Korean Journal of Nuclear Medicine Technology
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• v.14 no.1
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• pp.143-146
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• 2010

Purpose: Insulin is involved in carbohydrate metabolism and also it's very important because it increases storage of glycogen, synthesis of fatty acids, absorption of amino acid, synthesis of protein. Insulin is clinically useful when we evaluate fasting patients in hypoglycemia, classify and predict diabetes, assess the activity of ${\beta}$-cell, research insulin resistance. We are going to increase usability of insulin assay by establishing normal reference value according to statistical analysis. Material & Method: We selected 6,648 patients who visited asan health medical center from May to August in 2008. We set exclusion criteria as family of diabetes, diabetes medication, the past history of blood glucose rise, more than 100 mg/dL in normal fasting blood glucose, outside the scope of BMI 18.5~22.9 $kg/m^2$, and more than HbA1c 6.5%. We determine whether the subgroup is portioned as sex and age or not and establish normal reference value by conducting statistical analysis as Bayesian's method and Hoffman's method. Result: Portioning of subgroup as sex and age is not needed. By statistical analysis of Bayesian method, results 1.5-11.0 uIU/mL. By statistical analysis of Hoffman method, results 1.8~12.8 uIU/mL. Conclusion: We established 1.8~12.8 uIU/mL as Insulin normal reference value by Hoffman method. This is a similar value with reporting reference value 1.7~11.8 uIU/mL in kit. This will enhance the usability of insulin assay by establishing normal reference value.

• The Sea:JOURNAL OF THE KOREAN SOCIETY OF OCEANOGRAPHY
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• v.16 no.3
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• pp.147-154
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• 2011

Decision making in Environmental Impact Assessment (EIA) and Consultation on the Coastal Area Utilization (CCAU) is footing on the survey reports, thus requires concrete and accurate information on the natural habitats. In spite of the importance of reporting the ecological quality and status of habitats, the accumulated knowledge and recent techniques in ecology such as the use of investigated cases and indicators/indices have not been utilized in evaluation processes. Even the EIA report does not contain sufficient information required in a decision making process for conservation and development. In addition, for CCAU, sampling efforts were so limited that only two or a few stations were set in most study cases. This hampers transferring key ecological information to both specialist review and decision making processes. Hence, setting the effective number of sampling stations can be said as a prior step for better assessment. We introduced a few statistical techniques to determine the number of sampling stations in macrobenthos surveys. However, the application of the techniques requires a preliminary study that cannot be performed under the current assessment frame. An analysis of the spatial configuration of sampling stations from 19 previous studies was carried out as an alternative approach, based on the assumption that those configurations reported in scientific journal contribute to successful understanding of the ecological phenomena. The distance between stations and number of sampling stations in a $4{\times}4$ km unit area were calculated, and the medians of each parameter were 2.3 km, and 3, respectively. For each study, approximated survey area (ASA, $km^2$) was obtained by using the number of sampling stations in a unit area (NSSU) and total number of sampling stations (TNSS). To predict either appropriate ASA or NSSU/TNSS, we found and suggested statistically significant functional relationship among ASA, survey purpose and NSSU. This empirical approach will contribute to increasing sampling effort in a field survey and communicating with reasonable data and information in EIA and CCAU.

• Research in Community and Public Health Nursing
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• v.5 no.1
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• pp.81-96
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• 1994

The primary purpose of this study was to identify factors affecting health promoting lifestyles of college students on the basis of Pender's Health Promotion Model. The subjects were 1,159 students of one university in Seoul. These data were collected by self reporting questionnaire from April 19 to May 3, 1993. This study examined health promoting lifestyles, cognitive-percep-tual factors: perceived health status, perceived importance of health, health locus of control, and health conception, and modifying factors: sex, grade, major, residence type, and attendance at a health care course. The instruments used in this study were Health Promoting Lifestyle Profile by Walker et al. (1987), Health Value Scale by Wallston et al. (1976), Health Locus of Control by Wallston et al. (1978), and Health Conception Scale by Laffrey(1986). The data were analyzed by Cronbach's $\alpha$, mean, standard deviation, percentage, t-test, ANOVA, Pearson's Correlation Coefficient, and Stepwise Multiple Regression with SPSS PC+ Program. The results were as follows : 1. The means of health promoting lifestyles revealed total 3.33, self actualization 3.74, health responsibility 2.72, exercise 2.80, nutrition 3.55, interpersonal surpport 3.76, and stress management 2.96. Interpersonal support showed the highest score and health responsibility showed the lowest score. 2. No significant differences between sex, grade, major, and residence type, and health promoting lifestyles Were founded(p>.05). Attendants at a health care course showed a significant higher score than nonattendants (p<.001). Male showed a significant higher score in exercise subscale, female showed significant higher scores in health responsibility, nutrition, interpersonal support, stress management subscales(p<.001), residence type showed a significant difference in nutrition subscale(p<.001). 3. No significant differences between perceived health status and sex, grade, major, residence type, and attendance at a health care course were founded(p>.05). Perceived importance of health showed no differences among sex, grade, major, and residence type(p>.05), showed only in attendance at a health care course (p<.001). Attendants at a health care course showed a significant higher score than nonattendants(p<.001). No significant differences between health conception and sex, grade, major, and residence type were founded (p>.05), only significant difference between health conception and attendance at a health care course was founded(p<.05). Nonattendants showed a significant higher score in clinical health conception, attendants showed a significant higher score in wellbeing health conception(p<.05). 4. A significant positive correlation between health promoting lifestyles and perceived health status was founded(r=.2415, p<.001). A significant positive correlation between health promoting lifestyles and perceived importance of health was founded (r=.1475, p<.001). The health promoting lifestyles revealed significant positive correlations in internal and powerful others locus of control (r=.3187, p<.001: r=.1475, p<.001), but revealed a significant negative correlation in chance locus of control(r=-.997, p<.001). A significant positive correlation between health promoting lifestyles and clinical health conception and wellbeing health conception were founded (r=.1241, p<.001 : r=.3047, p<.001). 5. Perceived health status was the highest factor predicting health promoting lifestyles of college students(R=.3415, $R^2=11.62$). Perceived health' status, perceived improtance of health, internal locus of control, wellbeing health conception, powerful others locus of control accounted for 28.19% in health promoting lifestyle patterns. In conclusion, college students who reported more helath promoting lifestyles evaluated their health positively, perceived importance of health highly, perceived their health as affected by theirselves, powerful others but not by chance or luck, and accepted health as high level wellness rather than merely the absence of illness. Those who attending at a health care course had healthier lifestyle patterns. And attendance at a health care course had significant. correlations in these cognitive-perceptual factors. Further studies are required to identify reasons of attending a health care course, and to compare health promoting lifestyles pre-post attending a course related to health care.

• Journal of Korean Home Economics Education Association
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• v.17 no.4 s.38
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• pp.101-115
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• 2005

The purpose of this research was to develop and applicate In based teaching$\cdot$learning process plan for Environmentally friendly Housing. The 3 main stages of process were used: analyses, planning & development, and application & evaluation. Three teaching subjects were selected to teach Environmentally friendly housing in the analysis stage. The webhard learning environment was consisted of contents and various materials such as digital video, PPT, group activity, discussion, individual and group reporting forms, and questions. The number of 101 high school students participated for the application stage during september 22-27, 2003. Most of all students evaluated very positively the various aspects of contents as well as LT cooperative learning methods md the web based learning environment. They strongly expressed to practice the practical ways of Environmentally friendly housing learned in the class in the future. The results imply that the contents and In teaching learning plan developed in this study seem to be adequate to be included in the regular text.

• Clinical and Experimental Pediatrics
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• v.48 no.2
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• pp.138-142
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• 2005

Purpose : The purpose of the present study was to access the prevalence of orthostatic dysregulation(OD) and the frequency of each category for major and minor criteria among elementary school students using the OD questionnaire. Methods : We carried out inquiry by questionnaire as to the frequency of OD among two elementary schools with 725 students, 10 to 12 years of age, residing in Gwangju, Korea. The questionnaire was made according to criteria proposed by the Japan OD Study Group. Results : Of the 725 students(male 390; female 335) questioned, the OD was found in 338 students (53.5 percent). Prevalence of OD in males(59.2 percent) was significantly higher than in females(46.8 percent)(P<0.05). Palpitation with slight exercise(95.9 percent) was the most frequent major symptom. Headaches(85.8 percent) were the most frequent minor symptom among cases of OD. Conclusion : The prevalence of OD in elementary school students in this study(53.5 percent) was higher than in other studies. Contrary to studies from other countries, the male to female ratio was reversed. Because the diagnostic criteria seem to be dependent on subjective reporting of the symptoms, a newer diagnostic system based on more objective findings should be established.

• Korean Journal of Psychosomatic Medicine
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• v.27 no.2
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• pp.147-154
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• 2019

Objectives : Cognitive dysfunction, including inattention, is often observed in patients with depression. Inattentive symptoms in patients with depression is similar to those among attention deficit/hyperactivity disorder (ADHD) patients. It is important to diagnose the two diseases accurately, because the treatment varies depending on the cause of inattention. This study aimed to investigate the coexistence rate of ADHD and the correlation between ADHD symptoms and depression in patients with depression. Methods : Participants in this study were 158 outpatients presenting with depression, who visited the psychiatric department from March 2015 to July 2018. Participants divided into a depression and a non-depression group according to the Korean version of the Center for Epidemiological Studies-Depression Scale (CES-D) score and were administered the following : a sociodemographic variables form (age, sex, academic background, occupation), the self-reporting test for adult ADHD (Adult Attention Deficit/Hyperactivity Disorder self-report scale-V 1.1; ASRS V1.1), and the Korean version of the Connors adult ADHD rating scale (K-CAARS). Descriptive statistical analysis, crossover analysis, t-tests, and Pearson's correlation coefficient were conducted on the data. Results : The coexistence rate of adult ADHD symptom was as high as 36.7% in patients with depression (p<0.001). In K-CAARS, the depression group (Inattention=1.80, Hyperactivity=1.92, Impulsivity=1.56, Self-concept=2.06) showed higher average scores on ADHD symptoms than the non-depressive group (Inattention=1.28, Hyperactivity=1.25, Impulsivity=1.09, Self-concept=1.42, p<0.001). Conclusions : This study confirmed that ADHD symptoms coexist in the depression group. When evaluating the symptoms of patients who complain of depression, it is suggested that they should be accurately diagnosed and appropriately treated with interest to the coexistence of ADHD symptoms and the possibility for ADHD diagnosis.

• The Korean Society of Law and Medicine
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• v.21 no.1
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• pp.223-259
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• 2020

With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

• Childhood Kidney Diseases
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• v.11 no.2
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• pp.178-184
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• 2007

Purpose : Since the first report by Mendoza in 1990, there have been several studies reporting that long-term intravenous methylprednisolone(MP) pulse therapy combined with cyclosporin A(CsA) or cyclophosphamide might be beneficial for the treatment of steroid resistant focal segmental glometulosclerosis(FSGS). We investigated the therapeutic effect of long-term MP pulse therapy without CsA or cyclophosphamide on steroid resistant FSGS. Methods : The medical records of the 10 steroid resistant FSGS patients who were treated with MP pulse therapy by the Mendoza protocol without CsA or cyclophosphamide in our hospital were retrospectively reviewed. Results : The median age at onset was 2.6 years(range 1.1-10.6 years) and the median age at the initiation of therapy was 5.7 years(range 1.8-20 years). The median duration of follow-up was 35 months(range 4-132 months). At the end of therapy, 5 patients achieved complete remission(50%) and 2 partial remission(20%), one of whom relapsed after the therapy. Three patients did not respond to the therapy, two of whom progressed to end-stage renal failure during the therapy eventually requiring kidney transplantation. Conclusion : Intravenous long-term MP pulse therapy without CsA or cyclophosphamide by the Mendoza protocol may be effective in a subset of patients with steroid-resistant FSGS.