• Title/Summary/Keyword: assessment of safety

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A Comparison of Tiotropium 18㎍, Once Daily and Ipratropium 40㎍, 4 Times Daily in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults with Chronic Obstructive Pulmonary Disease (만성폐쇄성폐질환 환자에서 Tiotropium 1일 1회, 1회 18㎍ 요법과 Ipratropium 1일 4회, 1회 40㎍ 요법의 치료효과 및 안전성 비교)

  • Kim, Seung Joon;Kim, Myung Sook;Lee, Sang Haak;Kim, Young Kyoon;Moon, Hwa Sik;Park, Sung Hak;Lee, Sang Yeub;In, Kwang Ho;Lee, Chang Youl;Kim, Young Sam;Kim, Hyung Jung;Ahn, Chul Min;Kim, Sung Kyu;Kim, Kyung Rok;Cha, Seung Ick;Jung, Tae Hoon;Kim, Mi Ok;Park, Sung Soo;Choi, Cheon Woong;Yoo, Jee Hong;Kang, Hong Mo;Koh, Won Jung;Ham, Hyoung Suk;Kang, Eun Hae;Kwon, O Jung;Lee, Yang Deok;Lee, Heung Bum;Lee, Yong Chul;Rhee, Yang Keun;Shin, Won Hyuk;Kwon, Sung Yeon;Kim, Woo Jin;Yoo, Chul Gyu;Kim, Young Whan;Shim, Young Soo;Han, Sung Koo;Park, Hye Kyung;Kim, Yun Seong;Lee, Min Ki;Park, Soon Kew;Kim, Mi Hye;Lee, Won Yeon;Yong, Suk Joong;Shin, Kye Chul;Choi, Byoung Whui;Oh, Yeon Mok;Lim, Chae Man;Lee, Sang Do;Kim, Woo Sung;Kim, Dong Soon;Jung, Sung Soo;Kim, Ju Ock;Ko, Young Chun
    • Tuberculosis and Respiratory Diseases
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    • v.58 no.5
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    • pp.498-506
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    • 2005
  • Background : This study compared the bronchodilator efficacy and safety of tiotropium inhalation capsules ($18{\mu}g$ once daily) with a ipratropium metered dose inhaler (2 puffs of $20{\mu}g$ q.i.d.) in patients with chronic obstructive pulmonary disease (COPD). Method : After the initial screening assessment and a two-week run-in period, patients received either tiotropium $18{\mu}g$ once daily or ipratropium $40{\mu}g$ four times daily over a period of 4 weeks in a double blind, double dummy, parallel group study. The outcome measures were the lung function, the daily records of the peak expiratory flow rate (PEFR), the patients' questionnaire, and the use of concomitant salbutamol. The forced expiratory volume in one second ($FEV_1$) and the forced vital capacity (FVC) were measured 5 minutes before inhalation, and 0.5, 1, 2 and 3 hours after inhaling the study drug on days 0, 14 and 28. Result : In 16 centers, 134 patients with a mean (SD) age of 66 (7) years and a predicted $FEV_1$ of 42 (12)% were analyzed. The trough $FEV_1$ response was significantly higher in the tiotropium group than in the ipratropium group after a four-week treatment period. The weekly mean morning PEFR of the tiotropium group was consistently higher than that of the ipratropium group during the 4-week treatment period with differences ranging from 12.52 to 13.88 l/min, which were statistically significant. Tiotropium was well tolerated by the COPD patients during the 4-week treatment period and had a similar safety profile to ipratropium. Conclusion : This study shows that tiotropium administrated once daily has a superior bronchodilator effect with a similar safety profile in treating COPD patients compared with ipratropium, inhaled four times daily.

Development of the Monte Carlo Simulation Radiation Dose Assessment Procedure for NORM added Consumer Adhere·Non-Adhere Product based on ICRP 103 (ICRP 103 권고기반의 밀착형·비밀착형 가공제품 사용으로 인한 몬테칼로 전산모사 피폭선량 평가체계 개발)

  • Go, Ho-Jung;Noh, Siwan;Lee, Jae-Ho;Yeom, Yeon-Soo;Lee, Jai-Ki
    • Journal of Radiation Protection and Research
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    • v.40 no.3
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    • pp.124-131
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    • 2015
  • Radiation exposure to humans can be caused by the gamma rays emitted from natural radioactive elements(such as uranium, thorium and potassium and any of their decay products) of Naturally Occurring Radioactive Materials(NORM) or Technologically Enhanced Naturally Occurring Radioactive Materials(TENORM) added consumer products. In this study, assume that activity of radioactive elements is $^{238}U$, $^{235}U$, $^{232}Th$ $1Bq{\cdot}g^{-1}$, $^{40}K$ $10Bq{\cdot}g^{-1}$ and the gamma rays emitted from these natural radioactive elements radioactive equilibrium state. In this study, reflected End-User circumstances and evaluated annual exposure dose for products based on ICRP reference voxel phantoms and ICRP Recommendation 103 using the Monte Carlo Method. The consumer products classified according to the adhere to the skin(bracelet, necklace, belt-wrist, belt-ankle, belt-knee, moxa stone) or not(gypsum board, anion wallpaper, anion paint), and Geometric Modeling was reflected in Republic of Korea "Residential Living Trend-distributions and Design Guidelines For Common Types of Household.", was designed the Room model($3m{\times}4m{\times}2.8m$, a closed room, conservatively) and the ICRP reference phantom's 3D segmentation and modeling. The end-user's usage time assume that "Development and Application of Korean Exposure Factors." or conservatively 24 hours; in case of unknown. In this study, the results of the effective dose were 0.00003 ~ 0.47636 mSv per year and were confirmed the meaning of necessary for geometric modeling to ICRP reference phantoms through the equivalent dose rate of belt products.

Environmental Characteristics of Seawater and Sediment in Mariculture Management Area in Ongjin-gun, Korea (옹진군 어장관리해역의 수질 및 퇴적물 환경 특성)

  • Kim, Sun-Young;Kim, Hyung-Chul;Lee, Won-Chan;Hwang, Dong-Woon;Hong, Sok-Jin;Kim, Jeong-Bae;Cho, Yoon-Sik;Kim, Chung-Sook
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.19 no.6
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    • pp.570-581
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    • 2013
  • To improve productivity of aquaculture animals with management of culturing grounds, survey of mariculture management area in Ongjin-gun about water quality and sedimentary environment had been conducted on June, August and November in 2011. Water temperature in surface and bottom waters ranged from 9.49 to $24.14^{\circ}C$. Salinity and dissolved oxygen concentrations were in the range of 23.19~31.49 and 5.48~9.36 mg/L, respectively, depending on the variation of water temperature. The average concentration of COD was 1.57 mg/L and the concentrations of DIN and DIP showed entirely low level. As the result of grain size analysis, sand(56.66 %) and silt(34.60 %) were predominated. The Mz of sediment showed a variation of 2.59 to $6.62{\O}$ and sorting appeared to be poorly sorted. The concentrations of COD and IL in surface sediment ranged from 1.00 to $11.03mg/g{\cdot}dry$ and 0.72 to 5.29 %, respectively, which showed relatively good positive correlations. On the environmental assessment of trace metals in surface sediment, geoaccumulation index ($I_{geo}$) class indicated that sediments were not contaminated by most of metallic elements except Cr and As. Our result implies that this study area showed good water quality and sediments were not polluted by organic matters and metallic elements.

The Budget of Nutrients in the Estuaries Near Mokpo Harbor (목포항 주변 하구역의 영양염 수지)

  • Kim, Yeong-Tae;Choi, Yoon-Seok;Cho, Yoon-Sik;Oh, Hyun-Taik;Jeon, Seung-Ryul;Choi, Yong Hyeon;Han, Hyoung-Kyun
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.22 no.6
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    • pp.708-722
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    • 2016
  • Land-Ocean Interactions in the Coastal Zone (LOICZ) models for nutrient budgets were used to estimate the seasonal capacity of the Youngsan Estuary and Youngam-Geumho Estuary to sink and/or supply nutrients such as dissolved inorganic phosphorus (DIP) and nitrogen (DIN) to provide an understanding of the behavior of the coupled biogeochemical cycles of phosphorus and nitrogen in the estuaries (Youngsan Estuary, Youngam-Geumho Estuary) near Mokpo Harbor. During non-stratified periods (May, September, and November, 2008), simple three-box models were applied in each sub-region of the system, while a two-layer box model was applied during on-site observation of stratification development (July, 2008). The resulting mass-balance calculation indicated that even after large discharges from artificial lakes (in May and July), DIP influxes due to a mixing exchange ($V_{X-3}$, or $V_{deep}$) were more than terrigenous loads, indicating the backward transportation of nutrients from a marine source. The model results also indicated that for nutrient loads (DIP and DIN fluxes) in September, an extreme congestion of nutrients occurred around the mouths (sub-region III of the model) of the estuaries, possibly due to an imbalance in physical circulations between the estuaries and offshore locations. In November, the Youngam-Geumho Estuary, into which freshwater was discharged from artificial lakes (Youngam and Geumho Lake), showed nutrient enrichment in the water column, but the Youngsan Estuary showed nutrient depletion. In conclusion, to efficiently control water quality in the estuaries near Mokpo Harbor, integrated environmental management programs should be implemented. I.e., the reduction of nutrient loads from land basins as well as the deposit of nutrient loads into adjacent coastal lines.

Monitoring of Hazardous Metals Migrated from Home-Cooking Utensils (홈베이킹 조리기구에서 용출되는 유해금속 실태조사)

  • Park, Sung-Hee;Kim, Myung-Gil;Son, Mi-Hui;Seo, Mi-Young;Jang, Mi-Kyung;Ku, Eun-Jung;Chae, Sun-Young;Park, Yong-Bae
    • Journal of Food Hygiene and Safety
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    • v.36 no.3
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    • pp.264-270
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    • 2021
  • In this study we investigated the elution level of lead (Pb), cadmium (Cd), arsenic (As), zinc (Zn), nickel (Ni), antimony (Sb), germanium (Ge), aluminum (Al) and hexavalent chromium (Cr6+) from 69 home-cooking utensils into a food stimulants. The results of migration testing according to the Korea standards and specifications for utensils, containers and packages showed values the allowable migrantion limits. Al was detected in all 7 utensil materials with the average concentration ranging from 0.002-5.989 mg/L. According to the migration conditions for (180℃, 30 min), the average concentration of Al in paper was 7.2 times higher than 25℃, 10 min (P<0.05). The results of migration testing at 180℃, 30 min were also below the allowable migrantion limits. When comparing with the provisional tolerable weekly intake (PTWI) of Al, the estimated weekly intakes (EWI) accounted for 0.000-0.045% for Al.

Investigation on Natural Radioactivity of Environmental Samples Near the Phosphate Rock Processing Facility (인광석 사용업체 주변 환경시료의 자연방사능 조사)

  • Lee, Gill-Jae;Koh, Sang-Mo;Chang, Byung-Uck;Kim, Tong-Kwon;Kim, Young-Ug
    • Economic and Environmental Geology
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    • v.44 no.1
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    • pp.37-48
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    • 2011
  • Some industrial minerals used in domestic industries such as monazite, apatite, bauxite, and ilmenite belong to NORM (Naturally Occurring Radioactive Materials) because they show a high radioactivity. Products, semi-products, wastes, and by-products which show higher radioactivity than NORM belong to TENORM (Technologically Enhanced Naturally Occurring Radioactive Materials). Apatite used for manufacturing phosphate fertilizer in Namhae Chemical company belongs to NORM, and its by-product, phospo-gypsum, belongs to TENORM. A geological investigation is needed for the future environmental impact assessment of the Namhae Chemical company's site. According to survey results of the Namhae Chemical company's site, soil mineral composition indicated the mixture of minerals derived from the country rock (quartz, feldspar, mica, $l4{\AA}$ mineral, kaolin and amphibole) and minerals from the gypsum open-air storage yard (gypsum and apatite). Soil samples showed average content of U 4.6 ppm and Th 10 ppm, which are similar to average crustal abundances. They also show average contents of $^{40}K$ 191-1,166 Bq/kg, $^{226}Ra$ 15.6-710 Bq/kg, and $^{232}Th$ 17.4-72.7 Bq/kg, which indicate moderate levels of radio nuclide. But $^{226}Ra$ anomaly in the gypsum open storage yard is clearly confirmed and $^{232}Th$ anomaly is also confirmed in the east road side of the factory and nearby mountain areas. Soil external hazard indices ranged 0.24-2.01 with the average 0.54. Although most external hazard indices were lower than 1, which means radiation hazard index to be negligible, 5 samples out of total 40 samples showed higher values than 1, and further detailed investigation is needed.

Assessment of Both Standard and Isolated Vibrio parahaemolyticus on Efficacy of Commercial Sanitizers and Disinfectants (Vibrio parahaemolyticus 표준 및 식품분리 균주에 대한 살균소독제 유효성분별 감수성 평가)

  • Kim, Il-Jin;Kim, Yong-Su;Kim, Hyung-Il;Choi, Hyun-Chul;Jeon, Dea-Hoon;Lee, Young-Ja;Ha, Sang-Do
    • Journal of Food Hygiene and Safety
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    • v.22 no.2
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    • pp.127-131
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    • 2007
  • This study evaluated the bactericidal effect of 10 sanitizers and disinfectants such as ethanol (75 and 95%), iodine (15 and 25 ppm), chlorine (100 and 200 ppm), quaternary ammonium, acid, hydrogen peroxide, and peroxide acetic acid against V. parahaemolyticus. Ten strains of V. parahaemolyticus isolated from Korean foods and 4 strains of standard V. parahaemolyticus were compared for efficacies of various sanitizers and disinfectants by EN 1276 method based on quantitative suspension test. Ethanol (75 and 95%), 25 ppm of iodine, 100 ppm of quaternary ammonium, 145 ppm of hydrogen peroxide and acid showed more than $5log_{10}CFU/mL$ reduction in both clean and dirty conditions. Tests result of chlorine (100 ppm) showed more than $5log_{10}CFU/mL$ reduction in clean condition. Iodine (15 ppm) showed more than $5log_{10}CFU/mL$ reduction except 4 isolated and 1 standard V. parahaemolyticus in clean condition. iodine (15 ppm) also showed under $5log_{10}CFU/mL$ reduction $(0.93{\sim}3.73log_{10}CFU/mL)$ in dirty condition. Eleven hundred ppm of hydrogen peroxide was evaluated as weak sanitizer and disinfectant due to their $0.99{\sim}4.79log_{10}CFU/mL$ reduction on both clean and dirty conditions. Consequently, ethanol, iodine (25 ppm), chlorine (200 ppm), quaternary ammonium, acid and peroxide acetic acid were thought to be effective sanitizer and disinfectant against V. parahaemolyticus.

Microbial Contamination Levels in the Raw Materials of Home Meal Replacement Shabu-Shabu Meal Kit Distributed in Markets (가정간편식(Home Meal Replacement, HMR) 샤브샤브 밀키트의 원료별 미생물 오염도 분석)

  • Jeon, Eun Bi;Kim, Ji Yoon;Choi, Man-Seok;Choi, Seungho;Bang, Hyeon-Jo;Park, Shin Young
    • Journal of Food Hygiene and Safety
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    • v.35 no.4
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    • pp.375-381
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    • 2020
  • This study assessed the contamination levels of total aerobic bacteria, fungi, coliforms, Escherichia coli, Bacillus cereus, and Staphylococcus aureus and qualitative analysis of Salmonella spp. and Listeria monocytogens in six raw materials (beef, bean sprout, Chinese cabbage, king oyster mushroom, Korean cabbage, and sweet pumpkin) of home meal replacement (HMR) Shabu-Shabu meal kit distributed in markets. The total aerobic bacteria, fungi, and coliforms were detected as 3.98-6.50, 2.78-3.52, and 2.02-3.28 log CFU/g, respectively. Especially, beef was highly contaminated with total aerobic bacteria (6.50 log CFU/g) and coliforms (3.28 log CFU/g). Over 5 log CFU/g of total aerobic bacteria were also detected in bean sprout, Chinese cabbage, and sweet pumpkin. Less than < 2 log CFU/g of coliforms were detected in all vegetables. E. coli was not detected in any of the six samples (ND: < 1 log CFU/g). S. aureus was detected as 1.33-1.71 log CFU/g in most samples but it was not detected in beef and Korean cabbage. B. cereus was assessed as 1.15-2.01 log CFU/g in most samples but it was not detected in Korean cabbage. L. monocytogenes was qualitatively detected as 25-50% in most samples except for king oyster mushroom. Salmonella spp. were not qualitatively detected in any of the six samples. The microbial contamination levels determined in the current study may be potentially used as the basic data to execute microbial risk assessments of HMR foods such as Shabu-Shabu meal kit.

Analysis of the Relevance to Education for Sustainable Development and the Inquiry Tendency of 2015-Revised Middle School Home Economics Textbooks: Focusing on the 'Adolescence Consumption Life' Unit (2015 개정 중학교 가정 교과서 지속가능발전교육(ESD) 연관성 및 탐구 성향 분석: '청소년기의 소비생활' 단원을 중심으로)

  • Kim, Saetbyeol;Kim, Yeasle
    • Journal of Korean Home Economics Education Association
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    • v.32 no.3
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    • pp.161-177
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    • 2020
  • This research aims to identify the relevance of 'Adolescence consumption' units to ESD(Education for Sustainable Development), and to analyze the unit's inquiry tendency through the Romey analysis method. The assessment criteria in association with ESD developed in the previous literature were summarized and established to set up an analysis framework consisted of 11 key points including environmental perspective (natural resources, climate change/disaster prevention and mitigation, and sustainable rural and urban systems), economic perspective (corporate sustainability, market economy, and poverty gap mitigation), and socio-cultural perspective (human rights/peace/human protection, cultural diversity and understanding, health/safety, civic engagement, and management of nation). With this framework, the learning contents of 'adolescence consumption life' unit in twelve middle school Home Economics textbooks were analyzed including the texts, images/illustrations/tables/graphs, and activities. The analysis revealed that the core elements of the 'market economy' and 'management of nation' from the economic perspective were presented in three different formats: texts, images/illustrations/tables/graphs, and activities. However, relatively insufficient contents were presented in terms of health/safety, civic engagement, sustainable rural and urban systems, and corporate sustainability, and thus, development of textbooks dealing with various ESD contents is neededrecommended. Additionally, most textbooks' texts and images/illustrations/tables/graphs tend to be authoritative, while activities and assignments exhibited an inquiry tendency. It is advisable to incorporate a wider variety of ESD-related content in Home Economics classes and creatively employ inquiry-based learning activities for the development of pro-sustainable-development consumption values and behavioral tendencies among young students.

Assessment of Nutritional Components, Antioxidant Contents and Physiological Activity of Purple Corn Husk and Cob Extracts (자색옥수수 포엽과 속대 혼합 추출물의 영양성분, 항산화 활성 물질 함량분석 및 생리활성 평가)

  • Lee, Ki Yeon;Kim, Tae hee;Kim, Jai Eun;Park, A-Reum;Noh, Hee Sun;Kim, Si Chang;Ahn, Mun Seob;Kim, Hee Yeon
    • Journal of Food Hygiene and Safety
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    • v.33 no.6
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    • pp.500-509
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    • 2018
  • The objective of this study was to investigate the worth of extract husk and cobs of the Seakso 1 (EHCS) for the functional foods. We aimed to investigate the proximate composition, fatty acids, amino acids, antioxidant active substance contents, antioxidant activity, inhibitory activity of the ${\alpha}-amylase$ and ${\alpha}-glucosidase$. The proximate composition of the EHCS have represented 6.90% moisture, 7.31% crude ash, 0.52% crude fat and 7.07% crude protein. Among the 17 kinds of amino acids that were analyzed in thd EHCS, the glutamic acid was the highest, with 736.08 mg / 100 g. The fatty acids detected in the EHCS were palmitic acid oleic acid and linoleic acid. The proportion of the unsaturated fatty acids was 83.33%. We determined the contents of the antioxidant active substance by the total polyphenol and flavonoid. The total polyphenol and flavonoid contents were 99.87 mg/g and 25.02 mg/g, respectively. The antioxidative activity of the EHCS were determined using a DPPH and ABTS assay. In the antioxidative activity determination, the DPPH and ABTS radical scavenging activities were 95.62% ($1,000{\mu}g/mL$) and 92.00% ($10,000{\mu}g/mL$), respectively. The inhibitory activity of ${\alpha}-amylase$ and ${\alpha}-glucosidase$ (10 mg/mL) were 95.86% and 76.92%, respectively. These results suggest that the EHCS could be potentially used as a resource for the bioactive materials for health functional foods.