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Update of systemic treatments in severe/recalcitrant atopic dermatitis: Consensus document of the KAAACI working group on atopic dermatitis (난치 아토피피부염 전신 치료에 관한 전문가 의견서 업데이트)

  • Myongsoon Sung;Young-Il Koh;Mi-Ae Kim;Hyunjung Kim;Jung Im Na;Dong-Ho Nahm;Taek Ki Min;Yang Park;Dong Hun Lee;Mi-Hee Lee;So-Yeon Lee;Youngsoo Lee;Chong Hyun Won;Hye Yung Yum;Mira Choi;Eung Ho Choi;Woo Kyung Kim;KAAACI Work Group Report on the Treatment of Severe/Recalcitrant Atopic Dermatitis
    • Allergy, Asthma & Respiratory Disease
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    • v.12 no.2
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    • pp.58-71
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    • 2024
  • Atopic dermatitis (AD) is the most prevalent inflammatory skin condition, with approximately 80% of cases originating in childhood and some emerging in adulthood. In South Korea, the estimated prevalence of AD ranges between 10% and 20% in children and 1% and 3% in adults. Severe/recalcitrant AD manifests as a chronic, relapsing skin disorder, persisting with uncontrolled symptoms even after topical steroid treatment. Corticosteroids and systemic immunosuppression, conventionally the standard care for difficult-to-treat diseases, cause numerous undesirable side effects. When AD persists despite topical steroid application, systemic therapies like cyclosporine or systemic steroids become the second treatment strategy. The desire for targeted treatments, along with an enhanced understanding of AD's pathophysiology, has spurred novel therapeutic development. Recent advances introduce novel systemic options, such as biological agents and small-molecule therapy, tailored to treat severe or recalcitrant AD. Notably, dupilumab, a monoclonal antibody inhibiting interleukin 4 and 13, marked a transformative breakthrough upon gaining approval from the U.S. Food and Drug Administration (FDA) in 2017, leading to a paradigm shift in the systemic treatment of AD. Furthermore, both dupilumab and Janus kinase inhibitors, including baricitinib, abrocitinib, and tofacitinib, now approved by the Korean FDA, have established their applicability in clinical practice. These innovative therapeutic agents have demonstrated favorable clinical outcomes, effectively addressing moderate to severe AD with fewer side reactions than those associated with previous systemic immunosuppressants. This review summarizes the latest advancements and evidence regarding systemic treatments for AD, including newly approved drugs in Korea.

The Association of CHADS-P2A2RC Risk Score With Clinical Outcomes in Patients Taking P2Y12 Inhibitor Monotherapy After 3 Months of Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention

  • Pil Sang Song;Seok-Woo Seong;Ji-Yeon Kim;Soo Yeon An;Mi Joo Kim;Kye Taek Ahn;Seon-Ah Jin;Jin-Ok Jeong;Jeong Hoon Yang;Joo-Yong Hahn;Hyeon-Cheol Gwon;Woo Jin Jang;Hyuck Jun Yoon;Jang-Whan Bae;Woong Gil Choi;Young Bin Song
    • Korean Circulation Journal
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    • v.54 no.4
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    • pp.189-200
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    • 2024
  • Background and Objectives: Concerns remain that early aspirin cessation may be associated with potential harm in subsets at high risk of ischemic events. This study aimed to assess the effects of P2Y12 inhibitor monotherapy after 3-month dual antiplatelet therapy (DAPT) vs. prolonged DAPT (12-month or longer) based on the ischemic risk stratification, the CHADS-P2A2RC, after percutaneous coronary intervention (PCI). Methods: This was a sub-study of the SMART-CHOICE trial. The effect of the randomized antiplatelet strategies was assessed across 3 CHADS-P2A2RC risk score categories. The primary outcome was a major adverse cardiac and cerebral event (MACCE), a composite of all-cause death, myocardial infarction, or stroke. Results: Up to 3 years, the high CHADS-P2A2RC risk score group had the highest incidence of MACCE (105 [12.1%], adjusted hazard ratio [HR], 2.927; 95% confidence interval [CI], 1.358-6.309; p=0.006) followed by moderate-risk (40 [1.4%], adjusted HR, 1.786; 95% CI, 0.868-3.674; p=0.115) and low-risk (9 [0.5%], reference). In secondary analyses, P2Y12 inhibitor monotherapy reduced the Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding without increasing the risk of MACCE as compared with prolonged DAPT across the 3 CHADS-P2A2RC risk strata without significant interaction term (interaction p for MACCE=0.705 and interaction p for BARC types 2, 3, or 5 bleeding=0.055). Conclusions: The CHADS-P2A2RC risk score is valuable in discriminating high-ischemic-risk patients. Even in such patients with a high risk of ischemic events, P2Y12 inhibitor monotherapy was associated with a lower incidence of bleeding without increased risk of ischemic events compared with prolonged DAPT.

Why Is the Rate of Poor Subjective Health Notably High in South Korea? The Importance of Managing Healthcare Needs (한국인은 왜 주관적 건강상태가 매우 나쁠까? 의료필요 관리의 중요성)

  • Woojin Chung
    • Health Policy and Management
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    • v.34 no.3
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    • pp.334-346
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    • 2024
  • Background: Research on the link between subjective health and unmet healthcare needs is limited. This study examines whether experiences of subjective healthcare needs and unmet needs are related to subjective health in South Korea, where the rate of poor subjective health is notably high. Methods: This analysis utilized data from the Korea Health Panel (2014-2018), incorporating 68,930 observations from 16,535 adults aged 19 or older. The dependent variable, subjective health, was dichotomized into poor (bad or very bad) and non-poor (fair, good, or very good) categories. The primary variables of interest were the experiences of subjective healthcare needs and unmet needs, while control variables included 14 socio-demographic, health, and functional characteristics. The study employed population proportion analysis and multivariable two-level binary logistic regression analysis for each gender, accounting for the complex sampling design. Results: In 2018, the rate of reporting poor health was 8.7% (95% confidence interval [CI], 8.0%-9.5%) for men and 14.7% (95% CI, 13.8%-15.6%) for women. For both genders, compared to individuals whose healthcare needs were met, those without healthcare needs were less likely to report poor subjective health (adjusted odds ratio [AOR], 0.58; 95% CI, 0.39-0.86 for men; AOR, 0.59; 95% CI, 0.37-0.93 for women). Conversely, individuals whose healthcare needs were not met were more likely to report poor subjective health (AOR, 2.31; 95% CI, 2.01-2.65 for men; AOR, 2.19; 95% CI, 1.98-2.43 for women). A policy simulation indicated that reducing the experience of subjective healthcare needs would be approximately 5 times more effective in reducing poor subjective health than a policy focused on reducing the experience of unmet needs. Conclusion: South Korea must make significant efforts to reduce the deterioration of subjective health and promote appropriate healthcare utilization. To achieve this, a set of policies is recommended to address subjective healthcare needs. These policies should include (1) prompting individuals to proactively manage their own health, (2) providing primary healthcare similar to that in advanced countries, (3) ensuring the healthcare delivery system operates effectively, (4) decentralizing the healthcare management system, and (5) reducing the likelihood of people being misled into thinking they have a healthcare need.

Mitral Valvuloplasty using New Mitral Strip (Mitracon^{(R)}$) (새로운 Strip (Mitracon^{(R)}$)을 이용한 승모판막 성형술)

  • Kang, Seong-Sik;Kim, Sang-Pil;Song, Meong-Gum
    • Journal of Chest Surgery
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    • v.41 no.3
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    • pp.320-328
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    • 2008
  • Background: Numerous surgical devices for mitral repair have been used in the past with good results. In this study we describe a simple annuloplasty technique with using a new device ($Mitracon^{(R)}$). The aim of this study was to assess its efficacy and surgical results with using $Mitracon^{(R)}$. Material and Method: From May 2003 to October 2005, 46 patients (21 women and 25 men (mean age of $51.4{\pm}17.8$ years) with mitral regurgitation from various causes were treated with either the $Mitracon^{(R)}$ (the $Mitracon^{(R)}$ group) or the Capentier Edward rigid ring (the CE group). The median follow-up duration was 18.9 months. Result: The mean grade of mitral regurgitation before and immediately after surgery in the $Mitracon^{(R)}$ group and the CE group decreased from $3.2{\pm}0.8$ to $0.6{\pm}0.7$ and $3.4{\pm}0.7$ to $0.3{\pm}0.5$, respectively. There were no significant changes in the ejection fraction either between the two groups or before and immediately after surgery. No deaths were seen in either group. Early postoperative echocardiography of all 46 patients showed only trivial mitral regurgitation or none at all. Echocardiography at a median of 18.9 months also showed no progression in mitral regurgitation. The mean grade of mitral regurgitation in the $Mitracon^{(R)}$ group at this time point decreased from $3.2{\pm}0.8$ to $0.8{\pm}0.7$ (p<0.05). The CE group also showed a similar degree of decrease from $3.4{\pm}0.7$ to $0.3{\pm}0.6$ (p<0.05). The mitral valve area in the $Mitracon^{(R)}$ group at 1 year follow-up was $3.3{\pm}0.9cm^2$. The mitral valve area in the CE group was $2.7{\pm}0.6cm^2$. The mean mitral pressure gradient in the $Mitracon^{(R)}$ group at 1 year follow-up was $3.1{\pm}1.3$ mmHg. The mean pressure gradient in the CE group was $4.5{\pm}2.1$ mmHg, although any statistical significant difference for this between the groups was not reached. Conclusion: The present study showed the described technique to be safe and effective in the intermediate term. Because long term results are unavailable, a more extensive prospective randomized multicenter trial may be warranted to determine whether this procedure should be generally applied for repair of mitral valve disease.

Evaluation of the Neural Fiber Tractography Associated with Aging in the Normal Corpus Callosum Using the Diffusion Tensor Imaging (DTI) (확산텐서영상(Diffusion Tensor Imaging)을 이용한 정상 뇌량에서의 연령대별 신경섬유로의 변화)

  • Im, In-Chul;Goo, Eun-Hoe;Lee, Jae-Seung
    • Journal of the Korean Society of Radiology
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    • v.5 no.4
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    • pp.189-194
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    • 2011
  • This study used magnetic resonance diffusion tensor imaging (DTI) to quantitatively analyze the neural fiber tractography according to the age of normal corpus callosum and to evaluate of usefulness. The research was intended for the applicants of 60 persons that was in a good state of health with not brain or other disease. The test parameters were TR: 6650 ms, TE: 66 ms, FA: $90^{\circ}$, NEX: 2, thickness: 2 mm, no gap, FOV: 220 mm, b-value: $800s/mm^2$, sense factor: 2, acquisition matrix size: $2{\times}2{\times}2mm^3$, and the test time was 3 minutes 46 seconds. The evaluation method was constructed the color-cored FA map include to the skull vertex from the skull base in scan range. We set up the five ROI of corpus callosum of genu, anterior-mid body, posterior-mid body, isthmus, and splenium, tracking, respectively, and to quantitatively measured the length of neural fiber. As a result, the length of neural fiber, for the corpus callosum of genu was 20's: $61.8{\pm}6.8$, 30's: $63.9{\pm}3.8$, 40's: $65.5{\pm}6.4$, 50's: $57.8{\pm}6.0$, 60's: $58.9{\pm}4.5$, more than 70's: $54.1{\pm}8.1mm$, for the anterior-mid body was 20's: $54.8{\pm}8.8$, 30's: $58.5{\pm}7.9$, 40's: $54.8{\pm}7.8$, 50's: $56.1{\pm}10.2$, 60's: $48.5{\pm}6.2$, more than 70's: $48.6{\pm}8.3mm$, for the posterior-mid body was 20's: $72.7{\pm}9.1$, 30's: $61.6{\pm}9.1$, 40's: $60.9{\pm}10.5$, 50's: $61.4{\pm}11.7$, 60's: $54.9{\pm}10.0$, more than 70's: $53.1{\pm}10.5mm$, for the isthmus was 20's: $71.5{\pm}17.4$, 30's: $74.1{\pm}14.9$, 40's: $73.6{\pm}14.2$, 50's: $66.3{\pm}12.9$, 60's: $56.5{\pm}11.2$, more than 70's: $56.8{\pm}11.3mm$, and for the splenium was 20's: $82.6{\pm}6.8$, 30's: $86.9{\pm}6.4$, 40's: $83.1{\pm}7.1$, 50's: $81.5{\pm}7.4$, 60's: $78.6{\pm}6.0$, more than 70's: $80.55{\pm}8.6mm$. The length of neural fiber for normal corpus callosum were statistically significant in the genu(P=0.001), posterior-mid body(P=0.009), and istumus(P=0.012) of corpus callosum. In order of age, the length of neural fiber increased from 30s to 40s, as one grows older tended to decrease. For this reason, the nerve cells of brain could be confirmed through the neural fiber tractography to progress actively in middle age.

The National Survey of Acute Respiratory Distress Syndrome in Korea (급성호흡곤란증후군의 전국 실태조사 보고)

  • Scientific Subcommittee for National Survey of Acute Respiratory Distress Syndrome in Korean Academy of Tuberculosis and Respiratory Disease
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.1
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    • pp.25-43
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    • 1997
  • Introduction : The outcome and incidence of acute respiratory distress syndrome (ARDS) could be variable related to the varied definitions used for ARDS by researchers. The purpose of the national survey was to define the risk factors of ARDS and investigate the prognostic indicies related to mortality of ARDS in Korea according to the definition of ARDS determined by the American-European Concensus Conference on 1992 year. Methods : A Multicenter registry of 48 University or University-affliated hospital and 18 general hospital s equipped with more than 400 patient's beds conducted over 13 months of patients with acute respiratory distress syndrome using the same registry protocol. Results : 1. In the 12 months of the registry, 167 patients were enrolled at the 24 hospitals. 2. The mean age was 56.5 years (${\pm}17.2$ years) and there was a 1.9:1 ratio of males to females. 3. Sepsis was the most common risk factors (78.1%), followed by aspiration (16.6%), trauma (11.6%), and shock (8.5%). 4 The overall mortality rate was 71.9%. The mean duration was 11 days (${\pm}13.1$ days) from the diagnosis of ARDS to the death. Respiratory insufficiency appeared to be a major cause in 43.7% of the deaths followed by sepsis (36.1%), heart failure (7.6%) and hepatic failure (6.7%). 5. There were no significant differences in mortality based on sex or age. No significant difference in mortality in infectious versus noninfectious causes of ARDS was found. 6. There were significant differences in the pulse rate, platelet numbers, serum albumin and glucose levels, the amounts of 24 hour urine, arterial pH, $Pa0_2$, $PaCO_2$, $Sa0_2$, alveolar-arterial oxygen differences, $PaO_2/FIO_2$, and PEEP/$FI0_2$ between the survivors and the deaths on study days 1 through 6 of the first week after enrollment. 7. The survivors had significantly less organ failure and lower APACHE III scores at the time of diagnosis of ARDS (P<0.05). 8. The numbers of organ failure (odd ratio 1.95, 95% confidence intervals:1.05-3.61, P=0.03) and the score of APACHE III (odd ratio 1.59, 95% confidence interval:1.01-2.50, P=0.04) appeared to be independent risk factors of the mortality in the patients with ARDS. Conclusions : The mortality was 71.9% of total 167 patients in this investigation using the definition of American-European Consensus Conference on 1992 year, and the respiratory insufficiency was the leading cause of the death. In addition, the numbers of organ failure and the score of APACHE III at the time of diagnosis of ARDS appeared to be independent risk factors of the mortality in the patients with ARDS.

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2007-2011 Characteristics of Plant Virus Infections on Crop Samples Submitted from Agricultural Places (2007-2011 우리나라 농업현장 임상진단 요청 작물의 바이러스 감염 특성)

  • Kim, Jeong-Soo;Lee, Su-Heon;Choi, Hong-Soo;Kim, Mi-Kyeong;Kwak, Hae-Ryun;Kim, Jeong-Sun;Nam, Moon;Cho, Jeom-Deog;Cho, In-Sook;Choi, Gug-Seoun
    • Research in Plant Disease
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    • v.18 no.4
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    • pp.277-289
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    • 2012
  • The total number of requests and associated specimens for the diagnosis of virus infection were 573 and 2,992, respectively, on crops from agricultural places of farmers, Agricultural extension services and so forth for 5 years from 2007. The total number of virus tests was 13,325. The number of species of viruses infected on the submitted crops was 21 in 2007, 15 in 2008, 23 in 2009, 21 in 2010 and 17 in 2011. The newly recorded viruses were Tobacco leaf curl virus (TbLCV) in 2007, Tomato yellow leaf curl virus (TYLCV) in 2008, Impatience necrotic spot virus (INSV) and Radish mosaic virus (RaMV) in 2009, and Beet western yellows virus (BWYV) in 2010. Forty virus species including Alfalfa mosaic virus were detected over 5 years. The ten most frequently detected virus species were Cucumber mosaic virus (CMV), Tomato spotted wilt virus (TSWV), Tomato leaf curl virus (TYLCV), Cucumber green mottle mosaic virus (CGMMV), Broad bean wilt virus 2 (BBWV2), Zucchini yellow mosaic virus (ZYMV), Melon necrotic spot virus (MNSV), Pepper mild mottle virus (PMMoV), Watermelon mosaic virus (WMV) and Pepper mottle virus (PepMoV). The types of crops submitted from agricultural places were 51 in total and the ten most frequently submitted crops were red pepper, tomato, paprika, watermelon, melon, rice, cucumber, corn, radish and gourd. The total request rate for the top 10 crops and top 20 crops was 81.6% and 94.2%, respectively. Eight pepper infecting virus species included CMV, and the average infection rate was 24.6% for CMV, 18.9% for PMMoV and 14.7% for TSWV. Seven kinds of double infection were detected in pepper including BBWV2+CMV at 14.7% on average, and four types of triple infection including BBWV2+CMV+PepMoV at 0.9% on average. Six virus species detected on tomato including TYLCV, and the average infection rate was 50.6% for TYLCV, 14.5% for TSWV and 10.9% for Tobacco leaf curl virus (TbLCV). The mixed infection of CMV+TSWV on tomato was 3.9% on average and of Tomato mosaic virus (ToMV)+TYLCV was 0.4% on average. Five viruses detected on watermelon included MNSV and the average infection rate was 37.0% for MNSV, 20.4% for CGMMV, 18.1% for ZYMV and 17.8% for WMV. The mixed infection rate on watermelon was CMV+MNSV and WMV+ZYMV having an average infection rate of 0.7% and 5.0%, respectively. The average infection rates on melon were 77.6% for MNSV, 5.6% for CMV and 3.3% for WMV. Mixed infections of CMV+MNSV occurred on melon with an average infection rate of 13.5%.

Exposure Assessments of Environmental Contaminants in Ansim Briquette Fuel Complex, Daegu(II) - Concentration distribution and exposure characteristics of TSP, PM10, PM2.5, and heavy metals - (대구 안심연료단지 환경오염물질 노출 평가(II) - TSP, PM10, PM2.5 및 중금속 농도분포 및 노출특성 -)

  • Jung, Jong-Hyeon;Phee, Young-Gyu;Lee, Jun-Jung;Oh, In-Bo;Shon, Byung-Hyun;Lee, Hyung-Don;Yoon, Mi-Ra;Kim, Geun-Bae;Yu, Seung-do;Min, Young-Sun;Lee, Kwan;Lim, Hyun-Sul
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.25 no.3
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    • pp.380-391
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    • 2015
  • Objectives: The objective of this study is to assess airborne particulate matter pollution and its effect on health of residents living near Ansim Briquette Fuel Complex and its vicinities. Also, this study measured and analyzed the concentration of TSP, $PM_{10}$, $PM_{2.5}$, and heavy metals which influences on the environmental and respiratory disease in Ansim Briquette Fuel Complex, Daegu, Korea. Methods: In this study, we analyzed various environmental pollutants such as particulate matter and heavy metals from Ansim Briquette Fuel Complex that adversely affected local residents's health. In particular, we verified the concentration distribution and characteristics of exposure for TSP, $PM_{10}$, and $PM_{2.5}$ among particulate matters, and heavy metals(Cd, Cr, Cu, Mn, Ni, Pb, Fe, Zn, and Mg). In that regard, the official test method on air pollution in Korea for analysis of particulate matter and heavy metal in atmosphere were conducted. The large capacity air sampling method by the official test method on air pollution in Korea were applied for sampling of heavy metals in atmosphere. In addition, we evaluated the concentration of seasonal environmental pollutants for each point of residence in Ansim Briquette Fuel Complex and surrounding area. The sampling measured periods for air pollutants were from August 11, 2013 to February 21, 2014. Furthermore, we measured and analyzed the seasonal concentrations(summer, autumn and winter). Results: The average concentration for TSP, $PM_{10}$, and $PM_{2.5}$ by direct influence area at Ansim Briquette Fuel Complex were 1.7, 1.4 and 1.9 times higher than reference region. In analysis results of seasonal concentrations for particulate matter in four direct influence and reference area, concentration levels for winter were generally somewhat higher than concentrations for summer and autumn. The average concentrations for Cd, Cr, Mn, Ni, Pb, Fe, and Zn in direct influence area at Ansim Briquette Fuel Complex were $0.0008{\pm}0.0004{\mu}g/Sm^3$, $0.0141{\pm}0.0163{\mu}g/Sm^3$, $0.0248{\pm}0.0059{\mu}g/Sm^3$, $0.0026{\pm}0.0011{\mu}g/Sm^3$, $0.0272{\pm}0.0084{\mu}g/Sm^3$, $0.4855{\pm}0.1862{\mu}g/Sm^3$, and $0.3068{\pm}0.0631{\mu}g/Sm^3$, respectively. In particularly, the average concentrations for Cd, Cr, Mn, Ni, Pb, Fe, and Zn in direct influence area at Ansim Briquette Fuel Complex were 1.9, 3.6, 2.1, 1.9, 1.4, 2.6, and 1.2 times higher than reference area, respectively. The continuous monitoring and management were required for some heavy metals such as Cr and Ni. Moreover, the average concentration in winter for particulate matter in direct influence area at Ansim Briquette Fuel Complex were generally higher than concentrations in summer and autumn. Also, average concentrations for TSP, $PM_{10}$, and $PM_{2.5}$ were from 1.5 to 2.0 times, 1.2 to 1.8 times, and 1.1 to 2.3 times higher than reference area, respectively. In results for seasonal atmospheric environment, TSP, $PM_{10}$, $PM_{2.5}$, and heavy metal concentrations in direct influence area were higher than reference area. Especially, the concentrations in C station were a high level in comparison with other area. Conclusions: In the results, some particulate matters and heavy metals were relatively high concentration, in order to understand the environmental pollution level and health effect in surrounding area at Ansim Briquette Fuel Complex. The concentration of some heavy metals emitted from direct influence area at Ansim Briquette Fuel Complex were relatively higher than reference area. In particular, average concentration for heavy metals in this study were higher than average concentrations in air quality monitoring station for heavy metal for 7 years in Deagu metropolitan region. Especially, the residents near Ansim Briquette Fuel Complex may be exposed to the pollutants(TSP, $PM_{10}$, $PM_{2.5}$, and heavy metals, etc) emitted from the factories in Ansim Briquette Fuel Complex.

Dose Response Relationship in Local Radiotherapy for Hepatocellular Carcinoma (원발성 간암의 국소 방사선치료 시 선량반응 관계)

  • Park Hee Chul;Seong Jinsil;Han Kwang Hyub;Chon Chae Yoon;Moon Young Myoung;Song Jae Seok;Suh Chang Ok
    • Radiation Oncology Journal
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    • v.19 no.2
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    • pp.118-126
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    • 2001
  • Purpose : In this study, it was investigated whether dose response relation existed or not in local radiotherapy for primary hepatocellular carcinoma. Materials and Methods : From January 1992 to March 2000, 158 patients were included in present study. Exclusion criteria included the presence of extrahepatic metastasis, liver cirrhosis of Child's class C, tumors occupying more than two thirds of the entire liver, and performance status on the ECOG scale of more than 3. Radiotherapy was given to the field including tumor with generous margin using 6, 10-MV X-ray. Mean tumor dose was $48.2{\pm}7.9\;Gy$ in daily 1.8 Gy fractions. Tumor response was based on diagnostic radiologic examinations such as CT scan, MR imaging, hepatic artery angiography at $4\~8$ weeks following completion of treatment. Statistical analysis was done to investigate the existence of dose response relationship of local radiotherapy when it was applied to the treatment of primary hepatocellular carcinoma. Results : An objective response was observed in 106 of 158 patients, giving a response rate of $67.1\%$. Statistical analysis revealed that total dose was the most significant factor in relation to tumor response when local radiotherapy was applied to the treatment of primary hepatocellular carcinoma. Only $29.2\%$ showed objective response in patients treated with dose less than 40 Gy, while $68.6\%\;and\;77.1\%$ showed major response in patients with $40\~50\;Gy$ and more than 50 Gy, respectively. Child-Pugh classification was significant factor in the development of ascites, overt radiation induced liver disease and gastroenteritis. Radiation dose was an important factor for development of radiation induced gastroduodenal ulcer. Conclusion : Present study showed the existence of dose response relationship in local radiotherapy for primary hepatocellular carcinoma. Only radiotherapy dose was a significant factor to predict the objective response. Further study is required to predict the maximal tolerance dose in consideration of liver function and non-irradiated liver volume.

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A Prospective Randomized Comparative Clinical Trial Comparing the Efficacy between Ondansetron and Metoclopramide for Prevention of Nausea and Vomiting in Patients Undergoing Fractionated Radiotherapy to the Abdominal Region (복부 방사선치료를 받는 환자에서 발생하는 오심 및 구토에 대한 온단세트론과 메토클로프라미드의 효과 : 제 3상 전향적 무작위 비교임상시험)

  • Park Hee Chul;Suh Chang Ok;Seong Jinsil;Cho Jae Ho;Lim John Jihoon;Park Won;Song Jae Seok;Kim Gwi Eon
    • Radiation Oncology Journal
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    • v.19 no.2
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    • pp.127-135
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    • 2001
  • Purpose : This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy of ondansetron $(Zofran^{\circledR})$ 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg lid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Materials and Methods : Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tablets including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Results : Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was $52.9{\pm}11.2$ in group M, $46.5{\pm}9.5$ in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of weekly score for all three symptoms. Ondansetron $(Zofran^{\circledR})$ 8 mg bid dose and metoclopramide 5 mg lid dose were well tolerated without significant side effects. There were no clinically important changes In vital signs or clinical laboratory parameters with either drug. Conclusion : Concerning the fact that patients with younger age have higher emetogenic potential, there are possibilities that age difference between two treatment groups lowered the statistical power of analysis. There were significant difference favoring ondansetron group with respect to the severity of nausea, vomiting and loss of appetite. We concluded that ondansetron is more effective anti-emetic agents in the control of radiotherapy-induced nausea, vomiting, loss of appetite without significant toxicity, compared with commonly used drug, i.e., metoclopramide. However, there were patients suffering emesis despite the administration of ondansetron. The possible strategies to improve the prevention and the treatment of radiotherapy-induced emesis must be further studied.

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