• 한국가금학회:학술대회논문집
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• 한국가금학회 2003년도 국제 심포지움
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• pp.37-54
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• 2003

포유동물과 마찬가지로 암탉은 태어날 병아리에게 계란을 통해서 면역항체를 이행시켜 해로운 병원균의 침입으로부터 병아리를 보호해준다 . 즉 어미 닭의 혈청으로부터 특정항체가 난황에 이행되고 이 면역항체를 IgY 라고 부르며 이것이 발육중인 태아와 갓 부화한 병아리의 면역항체가 되는 것이다. 상대적으로 면역능력이 낮은 갓 부화한 병아리는 병원균에 대한 방어능력을 계란을 통해 어미로부터 받은 항체를 통해 얻는다. 그 결과, 난황 내에는 많은 양의 IgY를 보유하게 되고 이 면역물질이 있으므로 말미암아 계란 내에 들어와 있는 병원균이냐 외부에서 들어오려는 병원균을 무력화시켜 아무 탈없이 병아리가 부화하게 된다 . 이처럼 산란계에 각종 병원균을 접종함으로서 면역항체 IgY 가 많이 들어 있는 계란을 생산할 수 있다. 난황 1 개에는 136~340 mg 의 IgY 가 들어있고 이는 난황 $m\ell$ 당 8~20 mg의 IgY 가 함유되어 있는 셈이다. 그리고 산란계 한 마리로부터 일년에 30 g 이상의 IgY 를 얻을 수 있다. 산란계에 항원을 접종하여 난황으로부터 IgY 를 수확하면 IgY g 당 10＄ 도 안 되는 낮은 비용으로 항체를 얻을 수 있게 된다. 이에 비하여 포유동물의 경우 19 의 IgG 를 얻는데 20,000＄가 소요된다. 이와 같은 IgY 제조기술을 의학, 공중 보건, 수의학, 식품안전과 같은 분야에 응용을 함으로써 잠재력이 높은 새로운 시장을 여는 장이 될 것이다. IgY 기술을 더욱 폭넓게 활용할 수 있는 분야들로는 생물제제나 의학진단기구, 생리적 기능성 물질이나 기능성식품의 개발, 질병예방을 위한 경구투여제 그리고 질병감염을 막는 특정 병원균성 항미생물 제제와 같은 것들을 들 수 있다. 이 논문에서 우리가 강조하고자 하는 것은 IgY 가 함유된 계란을 생산하고 섭취하였을 때 특정항체들의 결합을 통해 병원성 미생물의 성장이나 군체를 형성하는 것을 무력화시켜 결과적으로 병원균을 감소시키거나 억제시킨다는 점이다. 오늘날 약물에 내성을 지닌 박테리아의 출현으로 질병감염을 막는데 항생제의 사용효과가 점차 감소하고 있기 때문에 이러한 항생제를 대체할 수 있는 방안으로 계란항체를 이용할 수 있다.

• Journal of Plant Biotechnology
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• 제42권3호
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• pp.257-264
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• 2015

본 연구에서는 식물조직배양기법을 통해 생산된 부정근과 이들의 표준 한약자원 약용부위에서 추출된 전세포추출물의 FT-IR스펙트럼 분석을 통해 대사체 수준에서의 동등성을 비교 분석함으로써 보다 안전하고, 균일한 한약자원 약용부위의 대체 공급수단을 개발하고자 하였다. 이를 위해 대표적인 한약자원 품목인 백수오(Cynanchum wilfordii), 백출(Atractylodes japonica), 하수오(Polygonum multiflorum), 그리고 황기(Astragalus membranaceus) 등 4 종류 약용식물의 표준 한약자원 약용부위와 기내에서 생산된 이들의 부정근들을 FT-IR 분석에 사용하였다. FT-IR 스펙트럼 데이터의 PCA (principal component analysis)와 PLS-DA (partial least square discriminant analysis) 분석결과 백수오와 황기의 표준 약용부위 시료들 사이에서 전체 대사체 패턴이 매우 유사함을 알 수 있었다. 특히 이들 한약자원 품목들의 경우 기내생산 부정근 시료들과도 전체 대사체 패턴이 매우 유사함을 알 수 있었다. 본 결과로 미루어볼 때 백수와 황기의 경우 기내에서 대량생산된 부정근이 이들 한약자원 품목의 약용부위에 대한 새로운 공급수단으로 활용이 가능함을 보여주는 결과라 사료된다. 그러나 백출과 하수오의 부정근 시료들의 경우 전체 대사체 패턴이 이들의 표준 약용부위 시료들과 차이를 보였다. 또한 본 연구를 통하여 다양한 한약자원 품목들의 약용부위 시료들로부터 빠르고 간편하게 전체 대사체 수준에서 유사도 비교가 가능함을 알 수 있었다. 따라서 본 연구에서 확립된 FT-IR 스펙트럼기반 다변량통계분석 기술은 다양한 한약자원 약용부위 시료들의 대사체 수준 동등성을 식별하는 수단으로 활용이 가능할 것으로 기대된다. 더 나아가 본 기술이 한약자원품목들의 성분 표준화에 크게 기여할 수 있을 것으로 사료된다.

• 농촌의학ㆍ지역보건
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• 제1권1호
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• pp.5-9
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• 1976

The categories of national health problems may be mainly divided into health promotion, problems of diseases, and population-economic problems which are indirectly related to health. Of them, the problems of diseases will be exclusively dealt with this speech. Rurality and Disease Problems There are many differences between rural and urban areas. In general, indicators of rurality are small size of towns, dispersion of the population, remoteness from urban centers, inadequacy of public transportation, poor communication, inadequate sanitation, poor housing, poverty, little education lack of health personnels and facilities, and in-accessibility to health services. The influence of such conditions creates, directly or indirectly, many problems of diseases in the rural areas. Those art the occurrence of preventable diseases, deterioration and prolongation of illness due to loss of chance to get early treatment, decreased or prolonged labour force loss, unnecessary death, doubling of medical cost, and economic loss. Some Considerations of Innovative Approach The followings art some considerations of innovative approaches to the problems of diseases in the rural Korea. 1. It would be essential goal of the innovative approaches that the damage and economic loss due to diseases will be maintained to minimum level by minimizing the absolute amount of the diseases, and by moderating the fee for medical cares. The goal of the minimization of the disease amount may be achieved by preventive services and early treatment, and the goal of moderating the medical fee may be achieved by lowering the prime cost and by adjusting the medical fees to reasonable level. 2. Community health service or community medicine will be adopted as a innovative means to disease problems. In this case, a community is defined as an unit area where supply and utilization of primary service activities can be accomplished within a day. The essential nature o the community health service should be such activities as health promotion, preventive measures, medical care, and rehabilitation performing efficiently through the organized efforts of the residents in a community. Each service activity should cover all members of the residents in a community in its plan and performance. The cooperation of the community peoples in one of the essential elements for success of the service program, The motivations of their cooperative mood may be activated through several ways: when the participation of the residents in service program of especially the direct participation of organized cooperation of the area leaders art achieved through a means of health education: when the residents get actual experience of having received the benefit of good quality services; and when the health personnels being armed with an idealism that they art working in the areas to help health problems of the residents, maintain good human relationships with them. For the success of a community health service program, a personnel who is in charge of leadership and has an able, a sincere and a steady characters seems to be required in a community. The government should lead and support the community health service programs of the nation under the basis of results appeared in the demonstrative programs so as to be carried out the programs efficiently. Moss of the health problems may be treated properly in the community levels through suitable community health service programs but there might be some problems which art beyond their abilities to be dealt with. To solve such problems each community health service program should be under the referral systems which are connected with health centers, hospitals, and so forth. 3. An approach should be intensively groped to have a physician in each community. The shortage of physicians in rural areas is world-wide problem and so is the Korean situation. In the past the government has initiated a system of area-limited physician, coercion, and a small scale of scholarship program with unsatisfactory results. But there might be ways of achieving the goal by intervice, broadened, and continuous approaches. There will be several ways of approach to motivate the physicians to be settled in a rural community. They are, for examples, to expos the students to the community health service programs during training, to be run community health service programs by every health or medical schools and other main medical facilities, communication activities and advertisement, desire of community peoples to invite a physician, scholarship program, payment of satisfactory level, fulfilment of military obligation in case of a future draft, economic growth and development of rural communities, sufficiency of health and medical facilities, provision of proper medical care system, coercion, and so forth. And, hopefully, more useful reference data on the motivations may be available when a survey be conducted to the physicians who are presently engaging in the rural community levels. 4. In communities where the availability of a physician is difficult, a trial to use physician extenders, under certain conditions, may be considered. The reason is that it would be beneficial for the health of the residents to give them the remedies of primary medical care through the extenders rather than to leave their medical problems out of management. The followings are the conditions to be considered when the physician extenders are used: their positions will be prescribed as a temporary one instead of permanent one so as to allow easy replacement of the position with a physician applicant; the extender will be under periodic direction and supervision of a physician, and also referral channel will be provided: legal constraints will be placed upon the extenders primary care practice, and the physician extenders will used only under the public medical care system. 5. For the balanced health care delivery, a greater investment to the rural areas is needed to compensate weak points of a rurality. The characteristics of a rurality has been already mentioned. The objective of balanced service for rural communities to level up that of urban areas will be hard to achieve without greater efforts and supports. For example, rural communities need mobile powers more than urban areas, communication network is extremely necessary at health delivery facilities in rural areas as well as the need of urban areas, health and medical facilities in rural areas should be provided more substantially than those of urban areas to minimize, in a sense, the amount of patient consultation and request of laboratory specimens through referral system of which procedures are more troublesome in rural areas, and more intensive control measures against communicable diseases are needed in rural areas where greater numbers of cases are occurred under the poor sanitary conditions.

• The Korean Journal of Physiology
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• 제20권1호
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• pp.53-63
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• 1986

과산화수소$(H_2O_2)$가 급성 일산화탄소(CO)중독의 회복에 미치는 영향을 알아보기 위하여 가토를 1% Corktm에 30분간 노출시킨후 자연회복군, 100%산소 흡입군 및 $H_2O_2$관장군(10ml/kg의 0.5% $H_2O_2$용액을 2ml내외의 사람혈액과 함께 관장)으로 나누어, 회복기 15,30,60 및 90분에 동맥혈의 $pH,\;PCO_2,\;CO_2$ 및 HbCO 포화도를 측정하여 다음과 같은 결론을 얻었다. pH는 급성 CO중독시 3개군 모두에서 감소하였고, 회복기에는 서서히 증가하여 자연회복군과 100%산소 흡입군은 회복기 90분에 거의 회복되나, $H_2O_2$관장군에서는 pH의 회복이 다른군보다 늦었다. $PaCO_2$는 급성 Co중독시 3개군 모두에서 감소하였고, 회복기에는 서서히 증가하였으나, 자연회복군의 $PaCO_2$는 회복기 90분에 거의 회복하는데 반하여 100%산소흡입군과 $H_2O_2$관장군의 $PaCO_2$는 회복이 늦었고 회복기 90분에도 완전히 회복되지 못하였다. $PaO_2$는 급성 Co중독시 약간 감소하였다가 회복기에는 회복기 15분부터 급격히 증가하였고 회복기 90분까지 대조치보다 높은 $PaO_2$를 유지하였다. 회복기동안 $H_2O_2$관장군의 $PaO_2$는 $102{\sim}107mmhg$로 자연회복군보다 약 10 mmhg 높은 수준을 보였다. HbCO 포화도는 급성 CO중독시 $54{\sim}72%$까지 증가하였다. 회복기에는 $H_2O_2$관장군의 HbCO 포화도의 회복이 자연회복군이나 100%산소 흡입군보다 빨랐으며, 100%산소 흡입군은 회복기 30분에서 60분사이에 자연회복군보다 더 빠른 회복을 보였다. 이상의 결과에서 0.5% $H_2O_2$관장은 CO중독시 혈액의 산소분압을 어느정도 증가시킬 뿐 아니라 혈색소와 결합된 CO의 해리를 촉진시켜, 단독요법 또는 산소요법과 병행하여 사용할 때 급성CO중독에 효과적인 치료법이 될 수 있을 것으로 사료된다.

• 대한치과기공학회지
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• 제22권1호
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• pp.179-198
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• 2000

Since dental prosthesis is made possible only when dental technicians give themselves to the study of knowledge and the acquisition of updated skills, continuing education is of great importance in that it makes up for the efforts of dental technicians. Accordingly, continuing education relates to a system designed to contribute to the enhancement of the talents of dental technicians and the dental health of the nation. Specialized knowledge and information may work as the best weapon to preserve their jbs. This is true of this modern society where no one can expecth to survive without acquiring knowledge and information constantly for work is getting more classified and more divirsifide. This paper is dedicated to take a look at the current condition of the continuing education of dental technicians and to come up with measure to make general evaluation and to improve continuing education. This research resorts to 609 questionnaires among 6433 copies save unfaithfully responded 34 copos with 6.431 dental technicians as the subjects enrolled in the Dental technician Association. The collected questionnaires consist of 365 dental technicians living in Seoul and of 244 ones, Which account for 11.8 percent of dental technicians enrolled in the association. Because dental technicians live more in local areas than Seoul, the generalization of this survey leaves something to be desired. I have come up with the following findings. 1. 6,431 dental technicians, or 36.3 percent of an total of 14,956 licensed dental technicians, were admitted as numbers of the Dental Tachnician Association as of October 31, 1999. In the '98 continuing education. 4,141 dental technicians among 4,711 dental technicians got relevant training, and in the '99 continuing education, 4,075 technicians, or 75.9 percent of 5,365 technicians got relevant training while 1,290 technicians or 24.2 percent, fail to get relevant training. 2. The survey has it that 38.1 percent of dental technicians are ignorant of the laws on continuing education, and that technicians staying in local communities(146 persons, or 61.6%) take more part in education than those living in the capital of Korea(159 persons, or 146%), and that the older they are, the more money they earn, the more carrer they have, the higher position they hold, the more part they take in education 3. According to the survey, those who have the experience of getting training more than three times account for 52 persons(16.8%) in Seoul and 47 persons(22.4%) in local districts(p<0.01). In terms of sanctions in relation to continuing education, 26 dental technicians(4.6%) say that they have ever gotten sanctions, and 533 dental technicians(95.4%) say that they haven't. And those who were absent from continuing education(72 technicians : 13.51%) didn't get any sanction. 4. In terms of the degree of understanding continuing education, local technicians(46.8% : 110 persons) have a higher understanding of continuing education than their countparts staying in Seoul(36.0% : 130). Continuing education is not the ultimate goal itself. It should be changed to motivate those who get education to be willing to take part in contunuing education, and to help dental technicians in a practical and specific way. And the branch societies should be developde to engage in more specialized and classified expert fields. Of course, the curriculum should be so selected that the conceptions of dental technicians may be reflected to the maximum extent, and the ultimate effores should be made to effect diversity in the ways of educational methods and to perfect the preparation of continuing education on the part of instructors. Regulations should be established in relation to continuing education with a veiew to enhancing the participation of continuing education and its effectiveness. The supervision of the Ministry of Health and Welfare is of great importance in this context. The regulation of continuing education is not administrative regulation, but the expression of national will to guarantee the medical service of the nation at highest level. Therefore, it is necessary that the Ministry of Health and Welfare should change their understanding of the needs for the continuing education of dental experts, and that the expertise of government employees in charge of continuing education should be expanded. It goes without saying that the government should suppory continuing education in a financial way so as to supply the person in charge of public welfare and control the quality of national medicine.

• 호스피스학술지
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• 제2권1호
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• pp.58-74
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• 2002

This paper constitutes a descriptive investigation and used a structured questionnaire to investigate nurses' and doctors' recognition of cancer patients. The subjects were extracted from the medical personnel working at the internal medicine, the surgery ward, the obstetrics and gynecology department, the pediatrics department, the cancer ward, and the emergency room of five general hospitals located in Seoul and Gyeonggi Province. The research lasted from August, 2001 to September 2001. Total 137 nurses and 65 doctors were included and made out the questionnaires directly distributed by the investigator. The study tool was also developed by the investigator and consisted of such items as the demographic and social characteristics, the medical personnel's recognition degree of cancer and cancer patients, their recognition of the management of cancer patients, and their participation in a hospice. The results were analyzed using the SPSS Window program in terms of technological statistics, ranks, t-test, and ANOVA. The reliability was represented in Cronbach' α=.75. The nurses' and doctors' recognition degree of cancer and cancer patients had an overall average of 3.86 at the 5 point-scale. The items that received an average of 4.0 or more included 'Medical personnel should explain about the cancer cure plans to the cancer patient and his or her family', 'A patient whose case has been diagnosed as a terminal cancer should be notified of it, 'If I were a cancer patient, I would want to get informed of it,' and 'Cancer shall be conquered whenever it is'. In the meantime, the items that received an average of 3.0 or less was 'My relationship with the cancer patient's family has gotten worse since I announced his or her impending death.' And according to the general characteristics and the difference test, the recognition degree of cancer and cancer patient was high among the subgroups of nurses, females, married persons, who were in their 30s, who had a family member that was a cancer patient, and who received a hospice education. The biggest number of the nurses and doctors saw 'a gradual approach over several days'(68.8%) as a method to tell a cancer patient about his or her cancer diagnosis or impending death. Those who usually tell tragic news were the physician in charge(62.8%), the family members or relatives(32.1%) and the clergymen(3.8%) in the order. The greatest number of them recommended a cancer patient's home as the place where he or she should face death because they thought 'it would stabilize his or her mentality'(91.9%) while a number of them recommended the hospital because they 'should give the psychological satisfaction to the patient'(40%) or 'should try their best until the last moment of the patient's death'(30%). A majority of the medical personnel regarded 'smoking or drinking' and 'diet' as the causes of cancer. The biggest symptom of a cancer patient was 'pain' and the pain management of a cancer patient was mostly impeded by the 'excessive fear of drug addiction, tolerance to drugs and side effects of drugs' by medical personnel, the patient, and his or her family. The most frequently adopted treatment plan of a terminal cancer patient was 'to do whatever the patient or his or her family wants' to resort to a hospice' and 'to continue active treatment efforts' in the order. The biggest reasons why a terminal cancer patient went to see a doctor were 'pain alleviation' 'control of symptoms other than pain(intravenous supply)' and 'incapability of the patient's family' in the order. Terminal cancer patients placed their major concern in 'spiritual(religious) matter' 'emotional matters' their family' 'existence' and 'physical matters' in the order. 113(58.5%) of the whole medical personnel answered they 'would recommend' an alternative treatment to a terminal cancer patient mostly because they assumed it would 'stabilize the patient's mentality.' Meanwhile, 80(41.5%) of them chose 'not to recommend it mostly due to the unverified effects and high cost of it(78.7%). A majority of them, I. e. 190(94.1%) subjects said they 'would recommend' a hospice to a terminal cancer patient mostly because they thought it would help the patient to 'mentally prepare'(66.6%) Only 17.3% of them, however, had received a hospice education, most of which was done through the hospital duty education(41.4%) and volunteer training(34.5%). The follows are results of this study: 1. The nurses and the doctors turned out to be still passive and experience confusion in dealing with a cancer patient despite their great sense of responsibility for him or her. 2.Nurses and Doctors realize the need of a hospice, but an extremely small number of them participate in a hospice education or performance. Thus, a whole recognition of a hospice should be changed, for which purpose a hospice education for nurses and doctors should be provided. 3.Terminal cancer patients preferred their home to a hospital as the place to face their impending death because they felt it would bring 'mental stability.' And most of nurses and doctors think it would be unnecessary for them to be hospitalized just for control of their symptoms. Accordingly a terminal cancer patient can be cared at home, and a home hospice care needs to be activated.

• 대한간호
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• 제36권1호
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• pp.59-76
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• 1997

The purposes of this study were to identify the contents and satisfaction level of the patients received home care service, and to compare the differences of the contents by the characteristics of the patients. Seventy eight patients received home care service from 1st Jan. to 30th Sept., 1996 were data-collected to analyze the contents and outcomes of home care service. Sixty-nine patients currently receiving home care service were participated to evaluate the satisfaction level of home care service. The data were analyzed using mean, standard deviation, $x^2$ test, and ANOVA by SPSS $PC^+$ program. The findings of this study were as follow : 1. The contents & outcomes of home care service 1) The mean age of the subjects was 64.4 years: 58% of them were female. Those who living in Seoul were 83% and the rest of the subjects was living in Kyung-Gi. 2) The subjects who had one diagnosis were 41%. Over 60% of them had the disease of neurologic & sensory system. 3) The mean number of visit was 6. Only one visit was 22%. The mean time of care was 79 minutes. Duration of visit from 31 minutes to 60 minutes were 47 %. The subjects who terminated the visit because of death were 67.3%. 62% of the persons who referred them to the home care service were nurses. 4) The pain after the service was more relieved than before. The amounts of intake, the degree of bed sore, edema & fracture after the service were more improved than before. Health status after the service was improved in general. 5) There were significant differences between initial and last conscious level in tracheostomy care & oxygen inhalation care. There was significant difference between initial and last degree of activity in blood sugar check. 6) There were significant differences on the number of visit in assessment of the status, evaluation & observation, vital sign check, skin care, injection, medication, bed sore care, colostomy care, relaxation therapy for pain relief, patient education, family care, exercise therapy, position change, supply of disinfected equipments and infection control. There were significant differences on visiting time in nasogastric tube care, drainage tube care and oxygen inhalation care. 2. The satisfaction level of home care service 1) 50% were male. Over 60 years of the subjects was 61 %. Those who living in Seoul were 82%. 2) The subjects who had one or two diagnosis were 32% respectively. 55% of the persons who referred them to the home care service were nurses. 3) Total level of satisfaction of home care service was very high. 4) The older the age, the higher the satisfaction level. The larger the number of visit, the higher the satisfaction level. 5) The subjects who were in cloudy state were higher level of satisfaction than in alert or coma state. The subjects whose activity were normal or who needed assistance were higher level of satisfaction than bedridden or immobilized subjects. These findings suggested that the patients had substantial need for posthospital care. They tended to be elderly and to have experienced the wide range of health problems associated with aging, chronicity, including limitations in activities, and other serious health problems. So, the nationwide home care systems beyond the limit of demonstration program by local association and the development of the effective financial system of home based health care are necessary for the clients who are in need of home care.

• Investigative Magnetic Resonance Imaging
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• 제9권1호
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• pp.9-15
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• 2005

목적 : 본 연구는 외부에서 고 농도$(30\%)$의 산소 공급이 공간 인지 능력에 어떠한 변화를 유발하는지 뇌기능 자기공명영상의 시계열 신호 분석을 통해 관찰하고자 한다. 대상 및 방법 : 비슷한 난이도의 공간 인지 과제 두 세트를 제작하기 위해 집단 검사를 실시하였다. 집단검사는 263명의 대학생을 대상으로 수행되었다. 그 결과 공간 인지 능력 측정을 위해 20 문항을 포함하는 두 개의 문제지를 제작하였다. 8명의 오른손잡이 남자 대학생(평균 23.5세)이 뇌기능 자기공명영상 실험의 피험자로 참여하였다. $21\%$와 $30\%$의 산소를 공급하면서 공간 인지 과제를 수행하는 두 번의 실험이 설계되었다. 각 실험은 네 개의 블록으로 구성되고, 각 블록은 통제 및 공간 과제로 구성되었다. 37 MRI 기기를 사용하여 single-shot EPI 방법으로 뇌기능 영상을 획득하였다. 감산법을 이용하여 공간 과제 수행 시 활성화되는 뇌 영역을 추출하였다. 활성화 영역의 시계열 신호 분석을 위해 대표적인 네 영역(소뇌, 후두엽, 두정엽, 전두엽)을 선정하였다. 결과 : 평균 정답률은 $21\%$와 $30\%$ 산소 농도에서 각각 $50.63{\pm}8.63$와 $62.50{\pm}9.64$ 이었고, 두 농도간의 통계적 유의차가 발생하였다 (p<0.05). $21\%$에 비해 $30\%$ 산소 농도에서 소뇌 후두엽, 두정엽, 전두엽 영역에서 신경 활성화의 면적이 증가하였다. 소뇌, 후두엽, 두정엽 영역의 신경 활성화 면적의 증가율은 약 $17\%$이었고, 전두엽은 약 $50\%$ 이었다. 특히, 공간 인지 처리와 가장 밀접한 관련이 있는 두정엽 영역에서는 신경 활성화 강도도 증가하였다. 좌 두정엽에서 신경 활성화 강도의 증가율은 약 $1.4\%$ 이었고, 우 두정엽은 약 $1.7\%$ 이었다. 결론 : 고농도의 산소가 과제수행에 필요한 산소 공급을 충분하게 하여 과제수행에 필요한 신경망을 보다 활성화시켰다. 그리고 그 결과로 과제 수행 능력도 증가시킨다는 결론을 도출할 수 있다.

• 기술혁신연구
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• 제28권4호
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• pp.1-26
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• 2020

전 세계적인 코로나19의 확산으로 인해, 진단시약 등과 같은 감염병 의료 및 의료기기 신제품이 비약적으로 개발·출시되고 있으며, 이의 빠른 수급을 위해 각 국가들은 수입규제를 완화하거나 신속한 인·허가를 위한 정책을 펼치고 있다(NIDS, 2020). 반면, 신종 감염병과 관련 없는 신개발 의료기기의 경우 오히려 시험검사 등 지연 및 취소되는 사례가 발생하고 있는 등 여전히 엄격한 인·허가규제를 통해 시장에 진출하고 있다. 이에 본 연구는 의료기기신제품이 시장에 진출하면서 마주하게 되는 정부소관법률에 특화하여 규제강도 영향요인을 도출하고 규제강도를 분석하여 규제대응 프레임워크를 제안하였다. 연구방법은 문헌연구, Failure Mode and Effects Analysis(FMEA)기법 적용, 전문가인터뷰(1차):아이디어수집, 전문가인터뷰(2차) : 타당성검증의 방법으로 진행하였으며, FMEA기법의 적용프로세스를 통해 우선 규제단계별 영향요인의 발생영향도와 규제사무 유형별 부담영향도를 곱하여 규제요인의 중요도를 구하고, 규제영향 심각도를 곱하는 방식으로 규제강도 정량화방법을 제시하였다. 시사점은 최근 해외 주요 국가들 및 우리나라 정부가 코로나19에 따른 신개발의료기기의 신속한 인·허가를 위한 특별규제정책 및 완화정책을 펼치며 적극적으로 대응하고 있는 시점에 본 연구에서 제안된 프레임워크를 통해 향후 기존 의료기기 신제품의 인·허가 정책 규제프로세스에도 보다 적극적이며 선제적인 대응이 될 수 있도록 규제의 개선방향과 규제대응 방안이 이루어지길 기대한다.

• 한국우주과학회:학술대회논문집(한국우주과학회보)
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• 한국우주과학회 1993년도 한국우주과학회보 제2권2호
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• pp.17-17
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• 1993

The wall shear stress in the vicinity of end-to end anastomoses under steady flow conditions was measured using a flush-mounted hot-film anemometer(FMHFA) probe. The experimental measurements were in good agreement with numerical results except in flow with low Reynolds numbers. The wall shear stress increased proximal to the anastomosis in flow from the Penrose tubing (simulating an artery) to the PTFE: graft. In flow from the PTFE graft to the Penrose tubing, low wall shear stress was observed distal to the anastomosis. Abnormal distributions of wall shear stress in the vicinity of the anastomosis, resulting from the compliance mismatch between the graft and the host artery, might be an important factor of ANFH formation and the graft failure. The present study suggests a correlation between regions of the low wall shear stress and the development of anastomotic neointimal fibrous hyperplasia(ANPH) in end-to-end anastomoses. 30523 T00401030523 ^x Air pressure decay(APD) rate and ultrafiltration rate(UFR) tests were performed on new and saline rinsed dialyzers as well as those roused in patients several times. C-DAK 4000 (Cordis Dow) and CF IS-11 (Baxter Travenol) reused dialyzers obtained from the dialysis clinic were used in the present study. The new dialyzers exhibited a relatively flat APD, whereas saline rinsed and reused dialyzers showed considerable amount of decay. C-DAH dialyzers had a larger APD(11.70${\pm}$1.32mmHg/min)compared to CF dialyzers(4.32${\pm}$0.55mmHg/min)(p<0.05). However, there was no observable difference in the UFR between the two dialyzers. Neither APD nor UFR showed any significant increase with an increasing number of reuses for up to more than 20reuses. A substantial number of failures observed in APD(larger than 20mmHe/min)on the reused dialyzers(2 out of 40 CP and S out 26 C-DAK) were attributed to the Possible damage on the fibers. The CF 15-11 HFDs which failed APD test did not show changes in the UFR compared to normal dialyzers indicating that APD is a more sensitive test than UFR test to evaluate the integrity of the fibers. 30527 T00401030527 ^x For quantitative measurement of reflected light from a clinical diagnostic strip, a prototype old reflectance photometer was designed. The strip loader and cassette were made to obtain more accurate reflectance parameters. The strip was illuminated at 45˚c through optical fiber and the intensity of reflected light was determined at rectanguLat angle using a photodiode. The kubelka-munk coefficient and reflection optical density were determined ar four different wavelengths(500,550,570 and 610nm) for blood glucose strip. For higher concentration than 300mg/41 about glucose, a saturation state of abforbance was observed at 500,550 and 570nm. The correlation between glucose concentration and parameters was the best at 610nm. 30535 T00401030535 ^x Radiation-induced fibrosarcoma tumors were grown on the flanks of C3H mice. The mice were divided into two groups. One group was injected with Photofrin II, intravenously (2.5mg/kg body weight). The other group received no Photofrin II. Mice from both groups were irradialed for approximately 15 minutes at 100,300, or 500 mW/cm2 with the argon (488nm/514.5 nm), dye(628nm) and gold vapor (pulsed 628 nm) laser light. A photosensitizer behaved as an added absorber. Under our experimental conditions, the presence of Photolfrin II increased surface temperature by at least 40% and the temperature rise due to 300 mW/cm2 irradiation exceeded values for hyperthermia. Light and temperature distributions with depth were estimated by a computer model. The model demonstrated the influence of wavelength on the thermal process and proved to be a valuable tool to investigate internal temperature rise. 30536 T00401030536 ^x We investigated the structural geometry of thirty-eight Korean femurs. The purpose of this study is to identify major geometrical differences between Korean femurs 3nd others that we believe belong to Caucasians so that we would be able to get insights into the femoral component design that fits Asians including Koreans. We utilized computerized tomography (CT) images of femurs extracted from cadavers. The CT images were transformed into bitmap data by using a film scanner, and then analyzed by using a commercially available software called Image v.1.0 and a Macintosh IIci computer.The resulting data were compared with already published data. The major results show that the geometry of the Korean femurs is significantly different from that of Caucasians: (1) the anteversion angle and the canal flare index are greater by the amount of approximately 8˚ and 0.5, respectively, (2) the shape of the isthmus cross section is more round, and (3) the distance between the teaser trochanter and the proximal border of the isthmus is shelter by about 15 mm. The results suggested that the femoral component suitable for Asians should be different from the currently-used components designed and manufactured mostly by European or American companies. 30537 T00401030537 ^x It is well known that nonlinear propagation characteristics of the wave in the tissue may give very useful information for the medical diagnoisis. In this paper, a new method to detect nonlinear propagation characteristics of the internal vibration in the tissue for the low frequency mechanical vibration by using bispectral analysis is proposed. In the method, low frequency vibration of f0( = 100Hz) is applied on the surface of the object, and the waveform of the internal vibration x (t) is measured from Doppler frequency modulation of silmultaneously transmitted probing ultrasonic waves. Then, the bispectra of the signal x (t) at the frequencies (f0, f0) and (f0, 2f0) are calculated to estimate the nonlinear propagation characteristics as their magnitude ratio, w here since bispectrum is free from the gaussian additive noise we can get the value with high S/N. Basic experimental system is constructed by using 3.0 MHz probing ultrasonic waves and the several experiments are carried out for some phantoms. Results show the superiority of the proposed method to the conventional method using power spectrum and also its usefulness for the tissue characterization. 30541 T00401030541 ^x This paper describes the implementation of a computerized radial pulse diagnosis by aids of a clinical expert. On this base, we composed of the radial pulse diagnosis system in korean traditional medicine. The system composed of a radial pulse wave detection system and a radial pulse diagnosis system. With a detection system, we detected Inyoung and Cheongu radial pulse wave and processed it. Then, we have got the characteristic parameters of radial pulse wave and also quantified that according to the method of Inyoung-Cheongu Comparison Radial Pulse Diagnosis. We defined the jugement standard of radial pulse diagnosis system and then we confirmed the possibility for realization of automatic radial pulse diagnosis in korean traditional medicine. 30545 T00401030545 ^x Microspheres are expected to be applied to biomedical areas such as solid-phase immunoassays, drug delivery systems, immunomagnetic cell separation. To synthesize microspheres for biomedical application, "two stage shot growth method" was developed. The uniformity ratio of synthesized microspheres was always smaller than 1.05. And the surface charge density (or the number of ionizable functional groups) of the microspheres synthesized by "two stage shot growth method" was 6~13 times higher than that of the microspheres synthesized by conventional seeded batch copolymerization. As a previous step for biomedical application, adsorption experiments of bovine albumin on microspheres were carried out under various conditions. The maximum adsorbed amount was obtained in the neighborhood of pH 4.5. Isoelectric point of bovine albumin is pH 5.0, so experimental result shows that it shifted to acid area. The adsorption isotherm was obtained, the plateau region was always reached at 2.Og/L (bulk concentration of bovine albumin).The effect of the kind and the amount of surface functional group was also examined. 30575 T00401030575 ^x A medical image workstation was developed using multimedia technique. The system based on PC-486DX was designed to acquire medical images produced by medical imaging instruments and related audio information, that is, doctors' reporting results. Input information was processed and analyzed, then the results were presented in the form of graph and animation. All the informations of the system were hierarchically related with the image as the apex. Processing and analysis algorithms were implemented so that the diagnostic accuracy could be improved. The diagnosed information can be transferred for patient diagnosis through LAN(local area network). 30592 T00401030592 ^x In the conventional infrared imaging system, complex infrared lens systems are usually used for directing collimated narrow infrared beams into the high speed 2-dimensional optic scanner. In this paper, a simple reflective infrared optic system with a 2-dimensional optic scanner is proposed for the realization of medical infrared thermography system. It has been experimentally proven that the intfrared thermography system composed of the proposed optic system has the temperature resolution of 0.1˚c under the spatial resolution of lmrad, the image matrix size of 256 X 240, and tile imaging time of 4 seconds. 30593 T00401030593 ^x In this paper, MIIS (Medical Image Information System) has been designed and implemented using INGRES RDBMS, which is based on a client/server architecture. The implemented system allows users to register and retrieve patient information, medical images and diagnostic reports. It also provides the function to display these information on workstation windows simultaneously by using the designed menu-driven graphic user interface. The medical image compression/decompression techniques are implemented and integrated into the medical image database system for the efficient data storage and the fast access through the network. 30594 T00401030594 ^x In this paper, computerized BEAM was implemented for the space domain analysis of EEG. Trans-formation from temporal summation to two-dimensional mappings is formed by 4 nearest point inter-polaton method. Methods of representation of BEAM are two. One is dot density method which classify brain electrical potential 9 levels by dot density of gray levels and the other is colour method which classify brain electrical 12 levels by red-green colours. In this BEAM, instantaneous change and average energy distribution over any arbitrary time interval of brain electrical activity could be observed and analyzed easily. In the frequency domain, the distribution of energy spectrum of a special band can easily be distinguished normality and abnormality. 30608 T00401030608 ^x Laboratory information system (LIS) is a key tool to manage laboratory data in clinical pathology. Our department has developed an information system for routine hematology using down-sized computer system. We have used an IBM 486 compatible PC with 16MB main memory, 210 MB hard disk drive, 9 RS-232C port and 24 pin dot printer. The operating system and database management system were SCO UNIX and SCO foxbase, respectively. For program development, we used Xbase language provided by SCO foxbase. The C language was used for interface purpose. To make the system use friendly, pull-down menu was used. The system connected to our hospital information system via application program interface (API), so the information related to patient and request details is automatically transmitted to our computer. Our system interfaced with fwd complete blood count analyzers(Sysmex NE-8000 and Coulter STKS) for unidirectional data tansmission from analyzer to computer. The authors suggests that this system based on down-sized computer could provide a progressive approach to total LIS based on local area network, and the implemented system could serve as a model for other hospital's LIS for routine hematology. 30609 T00401030609 ^x To develop an artificial bone substitute that is gradually degraded and replaced by the regenerated natural bone, the authors designed a composite that is consisted of calcium phosphate and collagen. To use as the structural matrix of the composite, collagen was purified from human umbilical cord. The obtained collagen was treated by pepsin to remove telopeptides, and finally, the immune-free atelocollagen was produced: The cross linked atelocollagen was highly resistant to the collagenase induced collagenolysis. The cross linked collagen demonstrated an improved tensile strength. 30618 T00401030618 ^x This paper is a study on the design of adptive filter for QRS complex detection. We propose a simple adaptive algorithm to increase capability of noise cancelation in QRS complex detection with two stage adaptive filter. At the first stage, background noise is removed and at the next stage, only spectrum of QRS complex components is passed. Two adaptive filters can afford to keep track of the changes of both noise and QRS complex. Each adaptive filter consists of prediction error filter and FIR filter The impulse response of FIR filter uses coefficients of prediction error filter. The detection rates for 105 and 108 of MIT/BIH data base were 99.3% and 97.4% respectively. 30619 T00401030619 ^x To develop an artificial bone substitute that is gradually degraded and replaced by the regenerated natural bone, the authors designed and produced a composite that is consisted of calcium phosphate and collagen. Human umbilical cord origin pepsin treated type I atelocollagen was used as the structural matrix, by which sintered or non-sintered carbonate apatite was encapsulated to form an inorganic-organic composite. With cross linking atelocollagen by UV ray irradiation, the resistance to both compressive and tensile strength was increased. Collagen degradation by the collagenase induced collagenolysis was also decreased. 30620 T00401030620 ^x We have developed a monoleaflet polymer valve as an inexpensive and viable alternative, especially for short-term use in the ventricular assist device or total artificial heart. The frame and leaflet of the polymer valve were made from polyurethane, To evaluate the hemodynamic performance of the polymer valve a comparative study of flow dynamics past a polymer valve and a St. Jude Medical prosthetic valve under physiological pulsatile flow conditions in vitro was made. Comparisons between the valves were made on the transvalvular pressure drop, regurgitation volume and maximum valve opening area. The polymer valve showed smaller regurgitation volume and transvalvular pressure drop compared to the mechanical valve at higher heart rate. The results showed that the functional characteristics of the polymer valve compared favorably with those of the mechanical valve at higher heart rate. 30621 T00401030621 ^x Explosive evaporative removal process of biological tissue by absorption of a CW laser has been simulated by using gelatin and a multimode Nd:YAG laser. Because the point of maximun temperature of laser-irradiated gelatin exists below the surface due to surface cooling, evaporation at the boiling temperature is made explosively from below the surface. The important parameters of this process are the conduction loss to laser power absorption (defined as the conduction-to-laser power parameter, Nk), the convection heat transfer at the surface to conduction loss (defined as Bi), dimensionless extinction coefficient (defined as Br.), and dimensionless irradiation time (defined as Fo). Dependence of Fo on Nk and Bi has been observed by experiment, and the results have been compared with the numerical results obtained by solving a 2-dimensional conduction equation. Fo and explosion depth (from the surface to the point of maximun temperature) are increased when Nk and Bi are increased.To find out the minimum laser power for explosive evaporative removal process, steady state analysis has been also made. The limit of Nk to induce evaporative removal, which is proportional to the inverse of the laser power, has been obtained. 30622 T00401030622 ^x N1 and N2 gross neural action potentials were measured from the round window of the guinea pig cochlea at the onset of the acoustic stimuli. N1-N2 audiograms were made by means of regulating stimulant intensities in order to produce constant N1-N2 potentials as criteria for different input tone pip frequencies. The lowest threshold was measured with an input tone pip I5 dB SPL in intensity and 12 KHz in frequency when the animal was in normal physiological condition. The procedure of experimental measurements is explained in detail. This experimental approach is very useful for the investigation of the Cochlear function. Both noN1inear and active functions of the Cochlea can be monitored by N1-N2 audiograms. 30623 T00401030623 ^x In electrical impedance tomography(EIT), we use boundary current and voltage measurements toprovide the information about the cross-sectional distribution of electrical impedance or resistivity. One of the major problems in EIT has been the inaccessibility of internal voltage or current data in finding the internal impedance values. We propose a new image reconstruction method using internal current density data measured by NMR. We obtained a two-dimensional current density distribution within a phantom by processing the real and imaginary MR images from a 4.77 NMR machine. We implemented a resistivity mage reconstruction algorithm using the finite element method and sensitivity matrix. We presented computer simulation results of the mage reconstruction algorithm and furture direction of the research. 30624 T00401030624 ^x A new method of digital image analysis technique for discrimination of cancer cell was presented in this paper. The object image was the Thyroid eland cells image that was diagnosed as normal and abnormal (two types of abnormal: follicular neoplastic cell, and papillary neoplastic cell), respectively. By using the proposed region segmentation algorithm, the cells were segmented into nucleus. The 16 feature parameters were used to calculate the features of each nucleus. A9 a consequence of using dominant feature parameters method proposed in this paper, discrimination rate of 91.11% was obtained for Thyroid Gland cells. 30625 T00401030625 ^x An electrical stimulator was designed to induce locomotion for paraplegic patients caused by central nervous system injury. Optimal stimulus parameters, which can minimize muscle fatigue and can achieve effective muscle contraction were determined in slow and fast muscles in Sprague-Dawley rats. Stimulus patterns of our stimulator were designed to simulate electromyographic activity monitored during locomotion of normal subjects. Muscle types of the lower extremity were classified according to their mechanical property of contraction, which are slow muscle (msoleus m.) and fast muscle (medial gastrocneminus m., rectus femoris m., vastus lateralis m.). Optimal parameters of electrical stimulation for slow muscles were 20 Hz, 0.2 ms square pulse. For fast muscle, 40 Hz, 0.3 ms square pulse was optimal to produce repeated contraction. Higher stimulus intensity was required when synergistic muscles were stimulated simultaneously than when they were stimulated individually. Electrical stimulation for each muscle was designed to generate bipedal locomotion, so that individual muscles alternate contraction and relaxation to simulate stance and swing phases. Portable electrical stimulator with 16 channels built in microprocessor was constructed and applied to paraplegic patients due to lumbar cord injury. The electrical stimulator restored partially gait function in paraplegic patients. 30626 T00401030626 ^x Two-Dimensional modelling of the Cochlear biomechanics is presented in this paper. The Laplace partial differential equation which represents the fluid mechanics of the Cochlea has been transformed into two-dimensional electrical transmission line. The procedure of this transformation is explained in detail. The comparison between one and two dimensional models is also presented. This electrical modelling of the basilar membrane (BM) is clearly useful for the next approach to the further. Development of active elements which are essential in the producing of the sharp tuning of the BM. This paper shows that two-dimension model is qualitatively better than one-dimensional model both in amplitude and phase responses of the BM displacement. The present model is only for frequency response. However because the model is electrical, the two-dimensional transmission line model can be extended to time response without any difficult. 30627 T00401030627 ^x A method has been proposed for the fully automatic detection of left ventricular endocardial boundary in 2D short axis echocardiogram using geometric model. The procedure has the following three distinct stages. First, the initial center is estimated by the initial center estimation algorithm which is applied to decimated image. Second, the center estimation algorithm is applied to original image and then best-fit elliptic model estimation is processed. Third, best-fit boundary is detected by the cost function which is based on the best-fit elliptic model. The proposed method shows effective result without manual intervention by a human operator. 30628 T00401030628 ^x The intelligent trajectory control method that controls moving direction and average velocity for a prosthetic arm is proposed by pattern recognition and force estimations using EMG signals. Also, we propose the real time trajectory planning method which generates continuous accelleration paths using 3 stage linear filters to minimize the impact to human body induced by arm motions and to reduce the muscle fatigue. We use combination of MLP and fuzzy filter for pattern recognition to estimate the direction of a muscle and Hogan's method for the force estimation. EMG signals are acquired by using a amputation simulator and 2 dimensional joystick motion. The simulation results of proposed prosthetic arm control system using the EMf signals show that the arm is effectively followed the desired trajectory depended on estimated force and direction of muscle movements. 30638 T00401030638 ^x A new neural network architecture for the recognition of patterns from images is proposed, which is partially based on the results of physiological studies. The proposed network is composed of multi-layers and the nerve cells in each layer are connected by spatial filters which approximate receptive fields in optic nerve fields. In the proposed method, patterns recognition for complicated images is carried out using global features as well as local features such as lines and end-points. A new generating method of matched filers representing global features is proposed in this network. 30659 T00401030659 ^x An implementation scheme of the magnetic nerve stimulator using a switching mode power supply is proposed. By using a switching mode power supply rather than a conventional linear power supply for charging high voltage capacitors, the weight and size of the magnetic nerve stimulator can be considerably reduced. Maximum output voltage of the developed magnetic nerve stimulator using the switching mode power supply is 3,000 volts and switching time is about 100 msec. Experimental results or human nerve stimulations using the developed stimulator are presented. 30768 T00401030768 ^x In this paper, we describe the design methodology and specifications of the developed module-based bedside monitors for patient monitoring. The bedside monitor consists of a main unit and module cases with various parameter modules. The main unit includes a 12.1" TFT color LCD, a main CPU board, and peripherals such as a module controller, Ethernet LAN card, video card, rotate/push button controller, etc. The main unit can connect at maximum three module cases each of which can accommodate up to 7 parameter modules. They include the modules for electrocardiograph, respiration, invasive blood pressure, noninvasive blood pressure, temperature, and SpO2 with Plethysmograph.