• 제목/요약/키워드: screening assessment

검색결과 617건 처리시간 0.031초

환경위해성 평가를 고려한 GM작물의 개발 전략 (I) (Strategies for the development of GM crops in accordance with the environmental risk assessment (I))

  • 이신우
    • Journal of Plant Biotechnology
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    • 제38권2호
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    • pp.125-129
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    • 2011
  • GM작물의 상용화를 위하여서는 반드시 환경위해성평가를 거쳐야 한다. 불행하게도 초기 event가 개발되고 기본적인 검토가 완료된 GM작물에 대하여 환경위해성평가를 수행하기 위하여서는 약 7백만에서 1,500만불의 경비가 소요되며 기간 또한 수년이 필요하다. 따라서 저자는 사용화를 위한 GM작물의 개발을 위한 프로젝트에 관여하는 개발자는 실험실 또는 온실단계의 아주 초기단계에서부터 환경위해성평가기준을 충분히 숙지하여야 한다고 제안한다. 기존의 많은 리뷰논몬에서 이미 지적된 것 과 같이 GM작물의 상용화과제에서 가장 큰 걸림돌(죽음의 계곡)은 초기 사상 (event)의 선발과정이며, 대부분이 이 단계에서 충분한 자료를 제시할 수 없어서 포기한다는 사실을 간과하여서는 안 될 것이다. 특히 지극히 기본적인 분자생물학 특성에 관한 자료들로서 예를 들어 도입유전자의 copy 수, 숙주의 게놈내 도입위치, 도입유전자의 주변 염기서열, 유전자 재배열과 도입유전자로 인한 숙주 내 기존유전자의 knock out 현상의 여부 등에 관한 충분한 자료를 제시하지 못하는 경우가 많으며 이는 GM 작물의 개발 초기단계에서부터 철저하게 검증이 이루어져야 하는 항목들이다. 국내의 경우, 농촌진흥청은 2011년부터 2020년까지 10년간 "차세대바이오그린 21 사업"을 발족하여 추진 중에 있으며 특히 국내용뿐만 아니라 중국의 사막화 지역 등 불량환경에 재배가 가능한 GM작물 등 해외로 수출을 위한 global GM작물의 개발을 위한 전략을 수립하여 추진 중에 있다. 따라서 저자는 환경위해성평가기준에 부합되는 초기 event의 선발 과정에 역점을 두어 사전에 분자생물학적 특성에 관한 RA기준을 고려하여 자체평가시스템을 도입하도록 제안 한다.

New in vitro multiple cardiac ion channel screening system for preclinical Torsades de Pointes risk prediction under the Comprehensive in vitro Proarrhythmia Assay concepta

  • Jin Ryeol An;Seo-Yeong Mun;In Kyo Jung;Kwan Soo Kim;Chan Hyeok Kwon;Sun Ok Choi;Won Sun Park
    • The Korean Journal of Physiology and Pharmacology
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    • 제27권3호
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    • pp.267-275
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    • 2023
  • Cardiotoxicity, particularly drug-induced Torsades de Pointes (TdP), is a concern in drug safety assessment. The recent establishment of human induced pluripotent stem cell-derived cardiomyocytes (human iPSC-CMs) has become an attractive human-based platform for predicting cardiotoxicity. Moreover, electrophysiological assessment of multiple cardiac ion channel blocks is emerging as an important parameter to recapitulate proarrhythmic cardiotoxicity. Therefore, we aimed to establish a novel in vitro multiple cardiac ion channel screening-based method using human iPSC-CMs to predict the drug-induced arrhythmogenic risk. To explain the cellular mechanisms underlying the cardiotoxicity of three representative TdP high- (sotalol), intermediate- (chlorpromazine), and low-risk (mexiletine) drugs, and their effects on the cardiac action potential (AP) waveform and voltage-gated ion channels were explored using human iPSC-CMs. In a proof-of-principle experiment, we investigated the effects of cardioactive channel inhibitors on the electrophysiological profile of human iPSC-CMs before evaluating the cardiotoxicity of these drugs. In human iPSC-CMs, sotalol prolonged the AP duration and reduced the total amplitude (TA) via selective inhibition of IKr and INa currents, which are associated with an increased risk of ventricular tachycardia TdP. In contrast, chlorpromazine did not affect the TA; however, it slightly increased AP duration via balanced inhibition of IKr and ICa currents. Moreover, mexiletine did not affect the TA, yet slightly reduced the AP duration via dominant inhibition of ICa currents, which are associated with a decreased risk of ventricular tachycardia TdP. Based on these results, we suggest that human iPSC-CMs can be extended to other preclinical protocols and can supplement drug safety assessments.

감각활동기반 인지재활 그룹 프로그램이 시설거주 치매노인의 인지기능과 우울 및 삶의 질에 미치는 효과 (Effect of Sensory Activity-Based Cognitive Rehabilitation Group Program on Cognitive Function, Depression and Quality of Life of Dementia Patients Living in a Facility)

  • 이혜식;양민아;김정란
    • 재활치료과학
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    • 제12권3호
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    • pp.79-88
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    • 2023
  • 목적 : 본 연구는 감각활동기반 인지재활 그룹 프로그램이 시설거주 치매노인의 인지기능과 우울감, 삶의 질에 미치는 영향에 대해 알아보고자 실시하였다. 연구방법 : 강원도 H군에 위치한 노인 요양시설에 거주하는 65세 이상 치매노인 8명을 대상으로 감각기반 인지재활 그룹 프로그램 총 20회기(사전/사후평가 포함)를 실시하였다. 대상자들의 인지기능, 우울수준과 삶의 질 수준을 프로그램 전과 후에 측정하였다. 결과 : 인지기능 평가에 사용한 한국어판 간이 정신상태 검사(Mini-Mental State Examination-Dementia Screening)의 평균점수는 증가하였지만 통계적으로 유의미한 차이는 없었다. 주관적 기억감퇴 설문지(Subjective Memory Complaints Questionnaire) 결과 통계적으로 유의한 향상이 있었다(p < .05). 우울정도 변화를 확인하기 위해 측정한 한국형 단축형 노인우울 척도(Short Geriatric Depression Scale, SGDS-K)의 사후평가 평균점수는 사전평가보다 향상을 보였으나 통계적으로 유의미한 차이는 없었다. 마지막으로 삶의 질의 변화를 확인하기 위해 측정한 세계보건기구 삶의 질 간편형 척도(World Health Organization Quality of Life assessment instrument-Brief) 결과에서 통계적으로 유의미한 향상이 있었다(p < .001). 결론 : 본 연구 결과를 통해서 시설에 거주하는 치매노인을 위한 감각활동기반 인지재활 그룹 프로그램 개발의 필요성과 유용성을 제시하는 데 기초적 근거를 마련할 수 있을 것이다.

가습기살균제 피해자의 아픔을 줄일 수 있었다 (It Was Possible to Reduce the Pain of the Victims of Humidifier Disinfectant)

  • 김판기;최윤형;박영철;박태현;임종한
    • 한국환경보건학회지
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    • 제48권1호
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    • pp.1-8
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    • 2022
  • Objectives: The purpose of this study is to reveal the circumstances under which the cases of harm to health caused by humidifier disinfectant were neglected and show the points where the number of victims and the degree of damage could have been reduced. In addition, it attempts to describe how damage management proceeded immediately after the incident and actually exacerbated the damage. Finally, it explores the unfortunate aspects of the recent trial. By doing so, it attempts to take this as an opportunity to consider whether a tragic event such as the humidifier disinfectant incident could occur in the future. Methods: This study collected and analyzed data on chemical material characteristics related to humidifier disinfectants, data on health effect characteristics, data on related laws and regulations from the Ministry of Environment, data related to the damage investigation by the Korea Environmental Industry and Technology Institute, and current contents. Results: The lack of related systems and laws is the area where the greatest responsibility for the cause of the humidifier disinfectant disaster falls, so it is difficult for the government to escape this responsibility. Establishing a dedicated department to identify the prevalence of certain diseases within the functions of the Health Insurance Review and Assessment Service to monitor health can greatly contribute to the prevention and management of diseases through early detection and management of group outbreaks caused by harmful factors. Humidifier disinfectant damage relief should have been expanded earlier beyond HDLI (humidifier disinfectant lung injury) to include non-specific diseases such as asthma, pneumonia, and interstitial pneumonia. The scope of relief benefits should have also been expanded earlier to include the payment of disability benefits. Fortunately, with the 2020 revision of the Special Act, the conditions for estimating causal relations were eased and individual screening systems such as health impact assessment were reorganized along with the introduction of a rapid screening system. Conclusions: The management system for chemical substances in a country is clearly of paramount importance, and the ministry in charge must have a response system in case of damage to health effects. Administration that looks at the victims' situation from their point of view is needed, and technical countermeasures are required to quickly recognize the prevalence of certain diseases.

Impact of Surveillance Mammography Intervals Less Than One Year on Performance Measures in Women With a Personal History of Breast Cancer

  • Janie M. Lee;Laura E. Ichikawa;Karen J. Wernli;Erin J. A. Bowles;Jennifer M. Specht;Karla Kerlikowske;Diana L. Miglioretti;Kathryn P. Lowry;Anna N. A. Tosteson;Natasha K. Stout;Nehmat Houssami;Tracy Onega;Diana S. M. Buist
    • Korean Journal of Radiology
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    • 제24권8호
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    • pp.729-738
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    • 2023
  • Objective: When multiple surveillance mammograms are performed within an annual interval, the current guidance for oneyear follow-up to determine breast cancer status results in shared follow-up periods in which a single breast cancer diagnosis can be attributed to multiple preceding examinations, posing a challenge for standardized performance assessment. We assessed the impact of using follow-up periods that eliminate the artifactual inflation of second breast cancer diagnoses. Materials and Methods: We evaluated surveillance mammograms from 2007-2016 in women with treated breast cancer linked with tumor registry and pathology outcomes. Second breast cancers included ductal carcinoma in situ or invasive breast cancer diagnosed during one-year follow-up. The cancer detection rate, interval cancer rate, sensitivity, and specificity were compared using different follow-up periods: standard one-year follow-up per the American College of Radiology versus follow-up that was shortened at the next surveillance mammogram if less than one year (truncated follow-up). Performance measures were calculated overall and by indication (screening, evaluation for breast problem, and short interval follow-up). Results: Of 117971 surveillance mammograms, 20% (n = 23533) were followed by another surveillance mammogram within one year. Standard follow-up identified 1597 mammograms that were associated with second breast cancers. With truncated follow-up, the breast cancer status of 179 mammograms (11.2%) was revised, resulting in 1418 mammograms associated with unique second breast cancers. The interval cancer rate decreased with truncated versus standard follow-up (3.6 versus 4.9 per 1000 mammograms, respectively), with a difference (95% confidence interval [CI]) of -1.3 (-1.6, -1.1). The overall sensitivity increased to 70.4% from 63.7%, for the truncated versus standard follow-up, with a difference (95% CI) of 6.6% (5.6%, 7.7%). The specificity remained stable at 98.1%. Conclusion: Truncated follow-up, if less than one year to the next surveillance mammogram, enabled second breast cancers to be associated with a single preceding mammogram and resulted in more accurate estimates of diagnostic performance for national benchmarks.

선별 검사를 위한 탁상용 폐활량기 (HI-801)의 임상적 유용성에 관한 고찰 (Clinical Value of a Desktop Spirometer (HI-801) for Spirometry Screening)

  • 최혜숙;최천웅;박명재;강홍모;유지홍
    • Tuberculosis and Respiratory Diseases
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    • 제62권4호
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    • pp.276-283
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    • 2007
  • 연구배경: 폐활량 검사는 간단하고 저렴한 폐질환의 선별 검사방법으로 흡연자나 호흡기 증상이 있는 환자에게 폐질환의 조기 발견을 위한 선별검사로 권고되고 있으며, 이에 따라 간단하고 저렴한 탁상용 폐활량 기기들이 공급되고 있다. 본 연구의 목적은 환기장애 소견을 보인 환자를 대상으로 탁상용 폐활량기와 병원 폐기능 검사실의 폐활량기의 폐활량 측정값을 비교 분석하여 그 일치도를 알아보고 이를 통해 탁상용 폐활량기의 임상환경에서의 정확성과 두 기기간의 임상적 상호 대체 허용성을 알아보고자 하였다. 방법: 2006년 4월부터 2006년 9월까지 경희의료원 건강검진 센터에서 HI-801기로 폐활량검사를 시행한 사람들 중 환기장애 소견을 보인 환자를 대상으로 폐기능 검사실에서 Vmax spectra 22d 폐활량기로 재검사를 시행하였다. 결과: 총 109명의 환자가 참여하였으며, 이 중 남자가 70명(64.2%)이었다. HI-801 기와 Vmax spectra 22d기로 측정한 폐활량 값들은 각각 FVC($3.03{\pm}0.62$ vs. $3.38{\pm}0.67L$), $FEV_1$($2.44{\pm}0.57$ vs. $2.61{\pm}0.58L$), PEFR($5.83{\pm}2.01$ vs. $7.70{\pm}2.11L/s$), FET($5.12{\pm}1.71$ vs. $6.68{\pm}1.11sec$), $FEF_{25%-75%}$($2.61{\pm}1.09$ vs. $2.48{\pm}1.08L/s$)였다. 두 기기간의 FVC, $FEV_1$, PEFR, $FEF_{25%-75%}$ 측정값의 상관 계수는 각각 r= 0.93, 0.94, 0.81, 0.84였으며, FVC, $FEV_1$은 Bland and Altman plot에서 95% 신뢰구간의 일치도 제한에서 각각 4%, 5% 만이 ${\pm}1.96SD$ 밖에 위치하였다. 결론: 탁상용 폐활량기인 HI-801 기는 병원 폐기능 검사실 Vmax spectra 22d 기와의 비교에서 높은 상관관계와 좋은 일치도를 보여, 탁상용 HI-801 기의 정확성을 알 수 있었으며, HI-801로 측정한 FVC, $FEV_1$ 값은 Vmax spectra 22d 기의 측정값을 임상적으로 대체할 수 있음을 보여주었다.

Inhibin-A를 추가한 Quad Test의 한국인 산모의 임신주수별 Median치에 대한 평가 (Evaluation of Gestational Age Median Value by Use of the Quad Test with Dimeric Inhibin A for Korea Pregnant Women)

  • 유자영;최삼규;조영숙;황도영
    • 대한임상검사과학회지
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    • 제37권1호
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    • pp.56-60
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    • 2005
  • Human chorionic gonadotrophin (hCG) and unconjugated estriol (uE3) were added to AFP to make what is commonly known as the Triple test. The Triple test combines results from these three tests and has been a standard screening procedure for several years. Recent studies have demonstrated the usefulness of adding inhibin-A to Down's syndrome risk assessment. The Quad test adds dimeric Inhibin-A (DIA) to the three other markers and uses the same computer program to calculate risk factors. Testing was performed between 14 and 21 weeks of gestation. Sample size were 648 samples and period of study was from 1, July, 2004 to 30, September, 2004. Used analytical methods for AFP, hCG and uE3 were radioimmunoassay (RIA) and dimeric inhibin A was enzyme-linked immunosorbent assay (ELISA). Adding dimeric inhibin-A as a fourth marker to the standard triple test increases the detection rate from 62 % to 75 % with a false-positive rate of 5%. The DIA based Quad test has been shown to be the most effective second trimester screening test for Down's syndrome suitable for routine use. Increased DIA values are observed during normal pregnancy where a bimodal pattern response is seen. Values increase during the first trimester, decline after 14 weeks, and re-ascend between 17-25 weeks. Values for DIA may be additionally elevated during a Down's syndrome pregnancy. Dimeric inhibin A is a glycoprotein hormone made by the ovary and placenta. DIA levels are twice as high in Down's syndrome pregnancies. AFP, hCG, and uE3 levels vary with gestational age, and incorrect gestational dating will influence results. DIA levels do not vary substantially with gestational age, resulting in greater screening accuracy. Although the Quad test is an improvement over the Triple test, it is important to underscore the fact that a positive test on both should be done. Most women who initially screen positive will be found to be carrying normal babies when amniocentesis and definitive diagnostic chromosome analysis are done.

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Array comparative genomic hybridization screening in IVF significantly reduces number of embryos available for cryopreservation

  • Liu, Jiaen;Sills, E. Scott;Yang, Zhihong;Salem, Shala A.;Rahil, Tayyab;Collins, Gary S.;Liu, Xiaohong;Salem, Rifaat D.
    • Clinical and Experimental Reproductive Medicine
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    • 제39권2호
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    • pp.52-57
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    • 2012
  • Objective: During IVF, non-transferred embryos are usually selected for cryopreservation on the basis of morphological criteria. This investigation evaluated an application for array comparative genomic hybridization (aCGH) in assessment of surplus embryos prior to cryopreservation. Methods: First-time IVF patients undergoing elective single embryo transfer and having at least one extra non-transferred embryo suitable for cryopreservation were offered enrollment in the study. Patients were randomized into two groups: Patients in group A (n=55) had embryos assessed first by morphology and then by aCGH, performed on cells obtained from trophectoderm biopsy on post-fertilization d5. Only euploid embryos were designated for cryopreservation. Patients in group B (n=48) had embryos assessed by morphology alone, with only good morphology embryos considered suitable for cryopreservation. Results: Among biopsied embryos in group A (n=425), euploidy was confirmed in 226 (53.1%). After fresh single embryo transfer, 64 (28.3%) surplus euploid embryos were cryopreserved for 51 patients (92.7%). In group B, 389 good morphology blastocysts were identified and a single top quality blastocyst was selected for fresh transfer. All group B patients (48/48) had at least one blastocyst remaining for cryopreservation. A total of 157 (40.4%) blastocysts were frozen in this group, a significantly larger proportion than was cryopreserved in group A (p=0.017, by chi-squared analysis). Conclusion: While aCGH and subsequent frozen embryo transfer are currently used to screen embryos, this is the first investigation to quantify the impact of aCGH specifically on embryo cryopreservation. Incorporation of aCGH screening significantly reduced the total number of cryopreserved blastocysts compared to when suitability for freezing was determined by morphology only. IVF patients should be counseled that the benefits of aCGH screening will likely come at the cost of sharply limiting the number of surplus embryos available for cryopreservation.

Development and Validation of a Breast Cancer Risk Prediction Model for Thai Women: A Cross-Sectional Study

  • Anothaisintawee, Thunyarat;Teerawattananon, Yot;Wiratkapun, Cholatip;Srinakarin, Jiraporn;Woodtichartpreecha, Piyanoot;Hirunpat, Siriporn;Wongwaisayawan, Sansanee;Lertsithichai, Panuwat;Kasamesup, Vijj;Thakkinstian, Ammarin
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권16호
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    • pp.6811-6817
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    • 2014
  • Background: Breast cancer risk prediction models are widely used in clinical practice. They should be useful in identifying high risk women for screening in limited-resource countries. However, previous models showed poor performance in derived and validated settings. Therefore, we aimed to develop and validate a breast cancer risk prediction model for Thai women. Materials and Methods: This cross-sectional study consisted of derived and validation phases. Data collected at Ramathibodi and other two hospitals were used for deriving and externally validating models, respectively. Multiple logistic regression was applied to construct the model. Calibration and discrimination performances were assessed using the observed/expected ratio and concordance statistic (C-statistic), respectively. A bootstrap with 200 repetitions was applied for internal validation. Results: Age, menopausal status, body mass index, and use of oral contraceptives were significantly associated with breast cancer and were included in the model. Observed/expected ratio and C-statistic were 1.00 (95% CI: 0.82, 1.21) and 0.651 (95% CI: 0.595, 0.707), respectively. Internal validation showed good performance with a bias of 0.010 (95% CI: 0.002, 0.018) and C-statistic of 0.646(95% CI: 0.642, 0.650). The observed/expected ratio and C-statistic from external validation were 0.97 (95% CI: 0.68, 1.35) and 0.609 (95% CI: 0.511, 0.706), respectively. Risk scores were created and was stratified as low (0-0.86), low-intermediate (0.87-1.14), intermediate-high (1.15-1.52), and high-risk (1.53-3.40) groups. Conclusions: A Thai breast cancer risk prediction model was created with good calibration and fair discrimination performance. Risk stratification should aid to prioritize high risk women to receive an organized breast cancer screening program in Thailand and other limited-resource countries.

유력 렘수면 행동장애 환자 유병률과 임상 양상-오산시 역학 연구 (Prevalence and Clinical Features of Probable REM Sleep Behavior Disorder-An Epidemiological Study in Osan City)

  • 최영민;윤인영;김기웅;이상돈;주가원;박준혁
    • 수면정신생리
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    • 제18권1호
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    • pp.23-28
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    • 2011
  • 목 적: 렘수면 행동장애는 기존 역학 연구에서 큰 관심을 받지 못했다. 본 연구는 유력 렘수면 행동장애의 유병률과 임상 양상에 대해 살펴보고자 하였다. 방 법: 오산시에 거주중인 60세 이상 노인 14,050명 중 1,588명이 임의추출을 통해 표본 집단으로 선정되었고 이들을 대상으로 렘수면 행동장애 선별 설문지로 선별검사를 시행했다. 선별 설문지 점수가 5 이상인 집단은 수면의학 전문가가 직접 개별 면담평가를 시행했다. 결 과: 14,050명의 모집단 중 886명이 1차 선별평가를 마쳤다. 선별검사 설문지 점수가 5 이상인 145명 중 123명이 2차 진단평가를 받았다. 이중 11명이 유력 렘수면 행동장애로 진단되었고 유병률은 1.5%(95% CI=0.70-2.30%)로 나왔다. 우울과 인지기능 저하의 빈도가 유력 렘수면 행동장애 진단군에서 그렇지 않은 군에 비해 유의미하게 증가되었다. 결 론: 유력 렘수면 행동장애는 노년층에서 드물지 않은 질환이지만 이에 대한 인식은 부족한 실정이다. 유력 렘수면 행동장애의 평가와 치료에 대한 관심이 더욱 요구된다.