• Title/Summary/Keyword: Drug safety assessment

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Review of Allowable Condition of the Discretionary not Covered Service (임의비급여 허용요건에 관한 검토)

  • Park, Tae-Shin
    • The Korean Society of Law and Medicine
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    • v.13 no.2
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    • pp.11-38
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    • 2012
  • The Supreme Court stand in the position in specific lawsuit that it doesn't allow the discretionary not covered service, but recently in revocation suit of fine disposal that is imposed on medical fee of leukemia patient, it altered the existing adjudgement and admitted the discretionary not covered service exceptionally. It put forward the allowable condition roughly in that case. According as this alteration, it has become more important to embody the allowance conditions of exceptions. The Supreme Court presented three things, which are procedural condition, medical condition and subscriber's agreement. Concerning procedural condition, several present conciliation procedures are as follows: medical care benefit arret request, relative value conciliation etc, prior request on anti-cancer drug among chemicals which exceed acceptance criteria, request of non benefit object on common drugs. To be granted the existence of those system, there should be no obstacle to use that. Even if it were so, we should take circumstances into consideration; individual situation is unescapable concerning substance and urgency of the discretionary not covered service, process of the procedure, time required etc. Regarding medical condition, safety and effectiveness will be verified through evaluation procedures of new medical skill. About the necessity, the Supreme Court made clear through a sentence that it allow the discretionary not covered service, in case that needs to treat a patient out of the standard of medical benefit. Strict interpretation is right and it answer the purpose of the sentence that the supreme court permit the discretionary not covered service, exceptionally. We need to differentiate medical necessity and medical validity. Subscriber's agreement should holds true if it entails full explanation, and if it is preliminary, explicit and individual. On this account, it should be difficult to admit that someone agree effectively when he call for the affirmation that he is recipient of medical care. Reasonable expense needs to be a part of review whether the agreement is valid. Meanwhile If we adjust system of medical expense and eventually reorganize a fee for consultation payment system (Fee-for-service controlled by item to DRG (Diagnosis Related Groups)), controversial area of the discretionary not covered service will be decreased and that will guarantee the discretion of the doctor.

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Dietary Behaviors and Total Sugar Intake from Snacks of Female College Students according to Sweet Taste Perception (여대생의 단맛 인지도에 따른 식행동 및 간식류를 통한 당류 섭취량 평가)

  • Kim, Mi-Hyun;Bae, Yun-Jung;Yeon, Jee-Young
    • The Korean Journal of Food And Nutrition
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    • v.29 no.2
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    • pp.267-274
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    • 2016
  • Increasing sugar intake of population has become a nutritional issue in Korea. Sweet taste perception may be related to behaviors such as eating sweet food including high sugars and total sugar intake. This study aimed to evaluate objective and subjective sweet taste perception and the association among objective sweet taste perception, dietary behaviors related to eating sweet snack food including high sugar, and total sugar intake from the snacks. Participants were 261 healthy female college students (mean age: $21.0{\pm}1.6years$), who were divided into three subgroups based on oral sweet taste evaluation using a sweet taste assessment tool provided by Ministry of Food and Drug Safety: sweet-seeker group (n=139), medium sweet-seeker group (n=54), and unsweet-seeker group (n=68). There was no significant difference in weight and body mass index (BMI) among the three groups; however, the sweet-seeker group had significantly higher sweet taste preference than that of the other groups. Though more people in the sweet-seeker group thought they tended to eat sweet foods than the medium sweet-seeker and unsweet-seeker groups, over half of the sweet-seekers did not think they tended to eat sweet foods. The sweet-seeker group was more likely to eat sweet snacks such as breads, chocolate products, sugar-sweetened milk, and so on than the unsweet-seeker group. Total sugar intake from the selected sweet snacks was 44.4 g for the sweet-seeker group, 34.4 g for the medium sweet-seeker group, and 28.0 g for the unsweet-seeker group with a significant difference. These results indicated the absence of relationship between objective sweet taste perception and the obesity index; however, significant associations were detected among objective sweet taste perception, eating sweet snacks and total sugar intake from the snacks. We also found high disagreement between objective and subjective sweet taste perception of the subjects. The present study provided the novel insight that measuring objective sweet taste perception may be useful for assessing the risk of high sugar consumption and undesirable dietary behaviors.

Physical Characteristic and In vitro Transdermal Delivery of PCL-b-PEG Micelles Containing Quercetin and Rutin (Quercetin과 Rutin을 함유하는 PCL-b-PEG 고분자 미셀의 특성 및 피부 흡수에 관한 In vitro 연구)

  • Lim, Gyu-Nam;Kim, Sun-Young;Kim, Min-Ji;Park, Soo-Nam
    • Polymer(Korea)
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    • v.36 no.4
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    • pp.420-426
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    • 2012
  • In this study, we prepared polymer micelles containing quercetin and rutin, known as antioxidants, using poly(${\varepsilon}$-caprolactone)-b-poly(ethylene glycol), and evaluated in vitro skin permeation of the active materials. Quercetin and rutin loaded micelles were characterized by DSC (differential scanning calorimetry), HPLC (high performance liquid chromatography) and DLS (dynamic light scattering) measurements. The particle size of the polymer micelles increased in a concentration dependent manner (0.5~2.0% PCL-b-PEG). The Zeta potential of quercetin and rutin loaded micelles remained constant. To evaluate the skin penetration of PCL-b-PEG micelles, Franz diffusion cell experiment was performed. The aqueous solutions of quercetin and rutin were used as the control groups. Quercetin and rutin loaded PCL-b-PEG micelles showed more efficient skin permeation than the control groups. Safety assessment (patch test) of quercetin and rutin loaded PCL-b-PEG micelles on skin was performed to test application possibility of the polymer micelles to cosmetics. Any adverse symptoms were not observed.

Fall Risk Assessment of the Elderly living in Nursing Home (노인요양시설 거주 노인의 낙상 위험요인 조사 연구)

  • Yang, Sun-Hee;Park, Young-Hae;Cho, Hae-Sook;Baek, Hee-Chong
    • Journal of Home Health Care Nursing
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    • v.12 no.2
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    • pp.1-15
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    • 2005
  • Purpose: This study was conducted to assess the fall risk factors. Method: The subjects were 87 persons who were older than 65 years living at 28 nursing home in Seoul and Gyunggi province. Subjects were interviewed using RAFS II for intrinsic factor and the environmental factor were assessed using a structured questionnaire from Oct. to Dec. in 2004. The data were analyzed by SPSS(ver. 12.0) programs, using descriptive statistics, $x^2$-test, and t-test. Result: The 37.9% of the subjects experienced the fall, and its average number is $1.94\pm1.75$. The Women's experience of the fall was higher than that of the men, but it was no significant difference with gender. There was no significant difference with the age and duration of living. The mean of the intrinsic risk factor was 13.38 in total score 39 points marks on the RAFS II scales. The intrinsic risk factor score of the fallen group 15.71 was significantly higher than the non-fallen group 12.10. The variables of recent fall experience(t=4.72, p=0.000) and urinary dysfunction(t=2.64, p=0.010) was significantly higher than the non-fallen group. The highest variable of the intrinsic factor was the age and the variables of drug intake, balance, chronic disease, recent fall experience, urinary dysfunction were followed in order. The mean of the environmental risk factor was 0.24 points. No significant differences were shown in environmental risk factor between the fallen and the non-fallen groups. To the fallen group, the place of entrance was the highest risky environmental factor. To see in area dimension, the floor surfaces was the highest risky environmental factor and equipment and illumination factor was the following risky elements in order. In the total score of environmental risk factors based on the ares, the fallen group was 0.26 and the non-fallen group was 0.24, but there were no significant differences between the groups. Conclusion: This results suggested that visual protection strategy, set up the safety device in the place of entrance and inner stairway, bathroom and nonskid mat in the nursing home would be contribute to the prevention of the fall for the elderly.

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Youth Risk Behavior Survey of Middle School Students in Daegu Metropolitan City (대구시 일부지역 중학생들의 건강관련 위험행동과 관련요인조사)

  • 이중정;이충원
    • Korean Journal of Health Education and Promotion
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    • v.19 no.3
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    • pp.51-72
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    • 2002
  • This research was conducted to understand and analyze the health-related behaviors of middle school students and get fundamental research data essential to provide efficient student guidance and public health service at school. The interview using Youth Risk Behavior Surveillance System(YRBSS). Translation and modification for Korean students of the YRBS. The Korean version of YRBS(Youth Risk Behavior Surveillance System) that translation and modification for Korean students of the YRBS developed by the Centers for Disease Control and Prevention(CDC)was used to assessment to health-related behaviors of youth. The interviewees were 1040 enrolled students at middle school in Daegu metropolitan city. YRBSS monitors six categories of priority health behaviors among youth and young adults behaviors that contribute to unintentional and intentional injuries; tobacco use; alcohol and other drug use, sexual behaviors that contribute to unintended pregnancy and sexually transmitted diseases(STDs)(including human immunodeficiency virus infection); unhealthy dietary behaviors; and physical activity. The result shows that over 30% of students rarely or never used safety belt and almost students were rarely or never wore a bicycle helmet. During the 12 months preceding the survey, 21.9% female students had felt so sad or hopeless almost every day for $\geq$ 2weeks in a row that they stopped doing some usually activities 20.5% of male middle school students have ever tried cigarette smoking. 26.2% of male students and 27.2% do female students had had over one drinks of alcohol during their lifetime(lifetime alcohol use). 47% of male students had had over one drinks of alcohol on $\geq$ 1 of the 30 days preceding the survey(current alcohol use). Over one half of female student were thought they were overweight. These results suggest that some risk behaviors be very prevalent in a korean middle school students and priority health-risk behaviors, which contribute to the leading cause of mortality and morbidity among youth and adult, often are establish during middle school age, extend into adulthood, are interrelated. Among both children and adults, the leading causes of death are closely linked to these behaviors. Among adults, chronic diseases such as cardiovascular disease, cancer, and diabetes are the national leading killers. Practicing healthy behaviors, such as eating low-fat, high-fruit-and-vegetable diets, getting regular physical activity, and refraining from tobacco use, would prevent many premature deaths. Because health-related behaviors are usually established in childhood, positive choices need to be promoted before damaging behaviors are initiated or become ingrained.

The Study of Correlation Between the Balance, Cognition and Activity of Daily Living in Stroke Patients (뇌졸중 환자의 균형, 인지, 일상생활 평가의 상관성 연구)

  • Kang, Bo-Ra;Jeong, Eun-Song;Kim, Jae-Hee;Ha, Yoo-Na
    • Journal of Korean Society of Neurocognitive Rehabilitation
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    • v.10 no.2
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    • pp.45-52
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    • 2018
  • The purpose of the present study was to determine correlations between the Berg Balance Scale (BBS), Montreal Cognitive Assessment-Korean (MoCA-K) and Modified Barthel Index (MBI) targeting stroke patients, and it seeks to analyze the influence among each factor to establish the fundamental research in evaluating the functional performance capability of stroke patients. The study was conducted between December 2017 and March 2018 and the target of the study was 34 stroke patients who are hospitalized and treated in Y rehabilitation hospital located in Goyang city. Following in criteria of how participants were selected. First, a person without the onset of 6months or more. Second, a person who can communicate and score over 20 points on MMSE-K. Third, a person without unilateral neglect. Fourth, a person without lower motor neuron lesion and orthopedic disease on the bilateral lower extremity. Fifth, a person without audiovisual problem and history of using drug or surgery that influence athletic function. sixth, patients who agreed on participating in the study. The evaluation was processed by measuring BBS, MoCA-K, and MBI with the occupational therapist and physical therapist. Also, one assistant was participated in measuring balanced ability for the safety reason. It was found that significantly correlates (p<.01) with BBS and MoCA-K (r=.459), BBS and MBI (r=.550), MoCA-K and MBI (r=.565). This study is meaningful that it provided the basis for the active use of BBS, MoCA-K and MBI as a clinical evaluation tool and its usefulness.

Residual Characteristics and Risk Assessments of Metalaxyl-M and Dinotefuran in Crown Daisy (Metalaxyl-M 및 dinotefuran 입제의 쑥갓 중 잔류 특성 및 위해성 평가)

  • Song, Min-Ho;Yu, Ji-Woo;Kim, Jinchan;Lee, Kwanghun;Ko, Rakdo;Keum, Young-Soo;Lee, Jiho
    • Korean Journal of Environmental Agriculture
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    • v.41 no.2
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    • pp.108-114
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    • 2022
  • BACKGROUND: This study was performed to determine residual characteristics of soil-treated metalaxyl-M and dinotefuran in crown daisy and to evaluate the risks from intake of the residual pesticides in the crop. METHODS AND RESULTS: The pesticide granules were treated in soil on two levels, and the plants samples were collected 51 days after seeding. The analytes were extracted and partitioned using the QuEChERS extraction packet (MgSO4 4 g, NaCl 1 g). The quantitative methods for metalaxyl-M and dinotefuran were validated in linearity, accuracy, and precision. Risk assessments of the pesticides were performed using Korea national nutrition statistics 2019. CONCLUSION(S): The residual concentrations of metalaxyl-M in crown daisy were 0.09-0.10 mg/kg (for the treatment at 6 kg/10 a) and 0.17-0.19 mg/kg (12 kg/10 a), respectively. The residual concentrations of dinotefuran in the crop were 0.53-0.75 mg/kg (3 kg/10 a) and 1.17-1.26 mg/kg (6 kg/10 a). The amounts of pesticides were less than MRL (Maximum Residue Limits) according to the Korean MFDS (Ministry of Food and Drug Safety). The HI (Hazard Index) of metalaxyl-M and dinotefuran for consumers was 0.0075% and 0.2250%, respectively. For females in the age between 50-64, the major consumer group, the HIs of the pesticides were <3%. Considering the consumption of crown daisy, they are not considered to be of toxicological concern.

A Double-Blind Comparison of Paroxetine and Amitriptyline in the Treatment of Depression Accompanied by Alcoholism : Behavioral Side Effects during the First 2 Weeks of Treatment (주정중독에 동반된 우울증의 치료에서 Paroxetine과 Amitriptyline의 이중맹 비교 : 치료초기 2주 동안의 행동학적 부작용)

  • Yoon, Jin-Sang;Yoon, Bo-Hyun;Choi, Tae-Seok;Kim, Yong-Bum;Lee, Hyung-Yung
    • Korean Journal of Biological Psychiatry
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    • v.3 no.2
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    • pp.277-287
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    • 1996
  • Objective : It has been proposed that cognition and related aspects of mental functioning are decreased in depression as well as in alcoholism. The objective of the study was to compare behavioral side effects of paroxetine and amitriptyline in depressed patients accompanied by alcoholism. The focused comparisons were drug effects concerning psychomotor performance, cognitive function, sleep and daytime sleepiness during the first 2 weeks of treatment. Methods : After an alcohol detoxification period(3 weeks) and a washout period(1 week), a total of 20 male inpatients with alcohol use disorder (DSM-IV), who also had a major depressive episode(DSM-IV), were treated double-blind with paroxetine 20mg/day(n=10) or amitriptyline 25mg/day(n=10) for 2 weeks. All patients were required to have a scare of at least 18 respectively on bath the Hamilton Rating Scale far Depression(HAM-D) and Beck Depression Inventory(BDI) at pre-drug baseline. Patients randomized to paroxetine received active medication in the morning and placebo in the evening whereas those randomized to amitriptyline received active medication in the evening and placebo in the morning. All patients performed the various tasks in a test battery at baseline and at days 3, 7 and 14. The test battery included : critical flicker fusion threshold for sensory information processing capacity : choice reaction time for gross psychomotor performance : tracking accuracy and latency of response to peripheral stimulus as a measure of line sensorimotor co-ordination and divided attention : digit symbol substitution as a measure of sustained attention and concentration. To rate perceived sleep and daytime sleepiness, 10cm line Visual analogue scales were employed at baseline and at days 3, 7 and 14. The subjective rating scales were adapted far this study from Leeds sleep Evaluation Questionnaire and Epworth Sleepiness Scale. In addition a comprehensive side effect assessment, using the UKU side effect rating scale, was carried out at baseline and at days 7 and 14. The efficacy of treatment was evaluated using HAM-D, BDI and clinical global impression far severity and improvement at days 7 and 14. Results : The pattern of results indicated thai paroxetine improved performance an mast of the lest variables and also improved sleep with no effect on daytime sleepiness aver the study period. In contrast, amitriptyline produced disruption of performance on same tests and improved sleep with increased daytime sleepiness in particular at day 3. On the UKU side effect rating scale, mare side effects were registered an amitriptyline. The therapeutic efficacy was observed in favor of paroxetine early in day 7. Conclusion : These results demonstrated thai paroxetine in much better than amitriptyline for the treatment of depressed patients accompained by alcoholism at least in terms of behavioral safety and tolerability, furthermore the results may assist in explaining the therapeutic outcome of paroxetine. For example, and earlier onset of antidepressant action of paroxetine may be caused by early improved cognitive function or by contributing to good compliance with treatment.

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Assessment of the Level of Microbial Contamination in Jinmichae (시판 진미채의 미생물학적 오염도 평가)

  • Om, Ae-Son;Kim, Ji-Hee;Moon, Ji-Hea;Jang, Mi-Kyung;Lee, Hyun-Ju
    • Culinary science and hospitality research
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    • v.15 no.4
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    • pp.1-8
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    • 2009
  • The aim of this study is to investigate the microbial contamination assessment of raw Jinmichae to cook and to establish its control. Three kinds of Korean Jinmichae products(K1, K2, K3) and three kinds of imported Jinmichae products(Chile: F1, Peru: F2, Mexico: F3) were collected from markets and department stores in Seoul and Gyeonggi-do. The results were as follows; Aerobic mesophilic bacteria in raw Jinmichae(F2) was detected $7.20{\times}10^7$ CFU/g, which exceeded the acceptable standard level, $1.0{\times}10^6$ CFU/g. The rest of raw groups fell up to $1.0{\times}10^3{\sim}1.0{\times}10^4$ CFU/g. Aerobic mesophilic bacteria were detected in blanched and fried Jinmichae groups. Boiled Jinmichae group did not exceed the acceptable standard level of $1.0{\times}10^6$ CFU/g. However, all the fried groups exceeded the level. E. coli were detected in raw Jinmichae but it was able to be controlled by blanching. Unlike this, E. coli was not completely controlled by roasting for 20 seconds relative to 40, 60 seconds. S. aureus were effectively controlled by boiling, however, it was not controlled by roasting. After roasting Jinmichae for 60 seconds, S. aureus were detected in the half of all groups. In this study, Jinmichae were found to be favorable one of side dishes in school meal service. Jinmichae can be contaminated by microbial pathogens such as S. aureus, E. coli, etc. Therefore, further studies are needed to monitor microbial pathogens and to provide their control.

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Microbial Contamination Levels of Fresh Vegetables Distributed in Markets (유통 중인 신선 채소류의 미생물 오염도 평가)

  • Choi Jin-Won;Park Shin Young;Yeon Ji-Hye;Lee Min Jeong;Chung Duck Hwa;Lee Kyu-Ho;Kim Min-Gon;Lee Dong-Ha;Kim Keun-Sung;Ha Sang-Do
    • Journal of Food Hygiene and Safety
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    • v.20 no.1
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    • pp.43-47
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    • 2005
  • This study monitored and compared the contamination levels of total aerobic bacteria, coliforms, Escherichia coli, and L. monocytogenes of either lettuce, sesame leaf, or cucumber sampled from either 15 super markets(SM) or 21 traditional markets(TM) located in both Seoul and the southern part of Gyunggi. Contamination levels of total aerobic bacteria and coliforms in lettuce, sesame leaf, or cucumber from SM or TM were not (p>0.05) significantly different. The highest contamination levels of total aerobic bacteria were observed in lettuce and followed by sesame leaf and cucumber. The contamination levels of total aerobic bacteria in lettuce, sesame leafs, and cucumbers were $7.01{\pm}0.14\;log_{10}CFU/g(SM)$ and $7.10{\pm}0.11\;log_{10}CFU/g(TM)$, $6.69{\pm}0.20\;log_{10}CFU/g(SM)$ and $6.44{\pm}0.13\;log_{10}CFU/g(TM)$, and $5.37{\pm}0.25 \;log_{10}CFU/g(SM)$ and $5.27{\pm}0.19\;log_{10}CFU/g(TM)$, respectively. A similar pattern of contamination rank was observed with the coliforms in three vegetables as was observed with the total aerobic bacteria E. coli were not significantly (p>0.05) different between SM and TM and isolated over $30\%$ in lettuce and sesame leaf and below $10\%$ in cucumbers. L. monocytogenes were not detected in all three vegetables(ND: cucumber <3 CFU/g, lettuce and sesame leaf <10 CFU/g). The microbial contamination levels determined in the present study may be used as the primary data to execute microbial risk assessment of fresh vegetables.