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        임상시험 시험대상자설명서의 가독성 평가

        최임순,용철순,이인향 한국임상약학회 2016 한국임상약학회지 Vol.26 No.1

        Background: Elements of informed consent including capacity, disclosure, understanding, voluntariness, and permission of the participant, are all crucial for clinical trials to be legally and ethically valid. During the informed consent process, the patient information leaflet is an important information source which prospective research subjects can utilize in their decision- making. In the adequate provision of information, KGCP guideline necessitate 20 specific items, as well as the use language that individuals can understand. This study measures the vocabulary level of patient information leaflets in an effort to provide an objective evaluation on the readability of such material. Methods: The word difficulty of 13 leaflets was quantitatively evaluated using Kim kwang Hae’s vocabulary grading framework, which was compared to the difficulty level of words found in the 6th grade Korean textbook. The quantitative outcomes were statistically analyzed using chi-squared tests and linear by linear association for ordinal data. Results: There was a statistically significant difference between the vocabulary level and frequency of words in leaflets and the 6th Korean textbook. The leaflets were on average 260 sentences and about roughly 15 pages long, including lay language (easier or equal to language used in primary school) of around 12% less; technical language of around 4.5% more. As the vocabulary grades increase, there was a distinct difference in vocabulary level between Korean textbook and each information leaflet (p < 0.001). Conclusion: Patient information leaflets may fail to provide appropriate information for self-determination by clinical trial subject through the difficulty level of its wording. Improvements in the degree of patients’ understanding and appropriate use of information leaflets are collaboratively equipped to strengthen patient’s autonomy and therefore guaranteeing participant’s rights.

      • 구리중독에 의한 생쥐간의 Acid-Phosphatase의 영양에 관한 연구

        최임순,유관희 연세대학교 자연과학연구소 1980 學術論文集 Vol.6 No.-

        구리가 생쥐간의 acid phosphatase의 활성과 간세포의 미세구조에 미치는 영향을 규명하기 위하여 CuSO_4를 농도별로 생쥐에 처리한 후 일정시간 후에 acid phosphatase의 활성도와 전자 현미경에 의한 미세구조의 변화에 대한 관찰결과 다음과 같은 결론을 얻었다. 1. Acid phosphatase의 활성도는 24시간까지는 대조군보다 감소하였으며 그후 72시간까지는 농도가 높을수록 증가하는 경향을 보였다. 2. 전자 현미경 관찰결과 모든 실험군에서 lysosome들의 출현이 뚜렷하였는데 10mg/kg body weight와 20mg/kg body weight 처리군에서는 대형의 lysosome들이 관찰되었다. 3. 20mg/kg body weight 처리군에서 미토큰드리아의 퇴행성인 변화가 관찰되었는데 종창된 미토큰드리아 내부에는 기질의 전자밀도가 낮아져 있었다. 4. 10mg/kg body weight와 20mg/kg body weight처리군에서 rough endoplasmic reticulum의 배열 양상이 대조군보다 상당히 불규칙함을 보였다. This investigation was conducted to determine the effects of acid phosphatase activity of mouse liver and of its microscopic ultrastructures. This was carried out by injecting CuSO_4 by density in variety into the mouse to study in a given time the degree of acid phosphatase activity, and changes taking place in the microscopic ultrastructures through electron microscopic method. Through this investigation, following conclusions were obtained: 1. The investigation showed a tendency that the degree of acid phosphatase activity decreased more than the control group up to 24 hours while it increased with increasing density then up to 72 hours. 2. As a result of electron microscopic observation, the emersion of lysosome was remarkable in all the groups of experiment and a large volume of lysosome was observed in the treatment group of 10mg/kg body weight and 20mg/kg body weight. 3. A degenerative change of mitochondria was observed in the treatment group of 20mg/kg body weight but in the internal part of mitochondria, the electron density of the stroma was lowered. 4. In the treatment group of 10mg/kg body weight and 20mg/kg body weight, the arrangement aspect of the rough endoplasmic reticulum was considerably more irregular than the control group.

      • 흰쥐 신피질 세포막과 소포체 막의 calcium 수송에 미치는 cadmium 및 metallothionein의 영향에 관한 연구

        최임순,김옥용,박용빈,Choe, Im-Sun,Kim, Ok-Yong,Park, Yong-Bin 한국통합생물학회 1993 동물학회지 Vol.36 No.4

        흰쥐의 신피질 세포막과 소포체 막을 분리하여 카드를 및 Metallothioneln(MT)을 투여하였을 때 세포막에 존재하는 Ca-ATPase에 미치는 영향을 측정하여 다음과 같은 결과를 얻었다. 전기영동상에서 분리된 MT가 분자량 12KD 정도의 위치에 band가 나타났으며, 분리한 각 세포의 막에 카드윰을 농도별로 처리하였을 때 고농도일수록 Ca-ATPase의 활성도가 감소하였으나, MT를 처리한 경우 신피질 세포막은 거의 대조군과 유사한 결과를 나타냈고, 소포체 막에 MT를 처리한 경우는 20mg/ml의 카드윰을 처리한 경우와 유사하였다. 이와같은 결과로 보아 카드윰은 세포막의 Ca-ATPase의 활성을 저하시켜 세포내 칼슘 항상성에 영향을 미치는 MT는 Ca-ATPase의 활성을 회복시켜 카드뮴에 의한 세포독성의 방어작용에 부분적으로 작용한 것으로 생각된다.

      • Testosterone과 dibutyryl cyclic AMP가 거세한 흰쥐 부정소의 $\beta$ -glucosidase와 몇가지 glycosidase 활성에 미치는 영향 및 부정소 상피세포의 여러 유형에 관한 연구

        최임순,정경순 한국통합생물학회 1989 동물학회지 Vol.32 No.3

        $\beta$-glucosidase, $\beta$-glucuronidase, N-acetyl-$\beta$-glucosaminidase의 성적 성숙과의 연관서을 조사하기 위하여 흰쥐의 복강내로 testosterone과 dibutryjry cyclic AMP 를 투여하여 위이 효소들의 활성도를 측정하였다. 그 결과 겨세한 실험군에서$\beta$-glucosidase와 N-acetyl-$\beta$-glucosaminidase이 활성도도 거세후 7일째에는 유의성있는 감소효과를 나타내었다. testosterone을 7일간 계속 투여한 경우에는 세 효소의 활성도가 모두 유의성있게 증가하였고 dbcAMP 투여군의 경우는 거세 14일째되는 실험군과 비슷하거나 감소하는 경향이 있었다. 미세구조를 관찰한 결과 부정소 상피세포의 유형은 크게 주세포와 기저세포로 나눌 수 있었으며 주세포는 일반적인 원주상피의 형태를 나타냈으며 소낭을 많이 포함하고 있는 narrow cell이 존재하였다. 특히 부정소미에는 다른 상피세포에 비해 전자밀도가 낮은 light cell이 존재했고 기저세포는 부정소 부위마다 비슷한 형태를 가지는 것으로 나타났으며 상피세포 사이에는 이동능력을 가진 halo cell이 존재했다. The activities of $\beta$-glucosidase, $\beta$-glucuronidase and N-acetyl-$\beta$-glucosaminidase were measured to investigate the relationships of them to sexual maturity. Peritoneal injections of testosterone and dibutyryl cAMP to rats were carried out. As a result, the activities of $\beta$-glucosidase and N-acetyl-$\beta$-glucosaminidase were significantly decreased from the third day and that of P -glucurondiase on the seventh day in the castrated groups. In addition, ihe activities of these three enzymes were significantly increased in the testosterone treated groups for 7 days. In case of dbcAMP injection, the activities of these three enzymes were similar to those of castrated groups or had a tendency to be decreased. On electron microscopic examination, principal cells, basal cells and narrow cells were observed in all regions of epididymis. Principal cells were general forms of columnar epithelial cells. Narrow cells had a number of small vesicles and light cells showed low electron density in comparison to other epithelial cells in cauda epididymis. Halo cells were migrating leucocytes btween epithelial cells.

      • 해조류(미역, 김)의 섭취가 흰쥐의 지질대사에 미치는 영향

        경선이,윤석권,최임순 同德女子大學校 1995 同大論叢 Vol.25 No.1

        The effect of laver and Undaria pinnatifida on lipid metabolism in the rats was studied. The young male rats were fed with different experimental diets containing 5% pectin, 5% cellulose, 5% laver, 10% laver, 5% Under ia pinnatifida, 10% Undaria pinnatifida and without fiber as control for 40 days. The contet of blood sugar, triglyceride and total cholesterol of liver and feces were investigated. The result obtained were summarized as follows ; 1. There was no significant difference in the food intake, body weight gain and feed effciency ratio by the supplementation of various fibers comparing to control group. 2. The liver weight was significantly higher in all fiber supplementation pectin and 10% laver compared with control treatment. The feces weight was significantly higher in all fiber supplemented groups than control. 3. The concentration of blood glucose and plasma triglyceride were unaffected by the addition of various fiber. 4. The contents of total lipid in plasma was markedly decreased in the pectin and 5% laver group than that of control. The total lipid concentration of liver in the 5% laver and 10% Undaria pinnatifida was significantly lower than that of control. On the other hand, total lipid contents of feces in all fiber group was significantly higher than control. 5. In fiber supplemented groups, total cholesterol concentration in plasma was depressed comparing to that of control. However, the contents of total cholesterol in liver was greatly lowered by 10% Undaria pinnatifida. In fiber supplemented group, significant higher lebel of total cholesterol concentration of feces was estimated. 6. Concentration of feces bile acid was significantly higher in the fiber groups except pection as acomparing to control group. 7. The blood pressure was depressed in pectin group and laver but showed increasing tendency in other groups.

      • 초기 계배의 뇌형성에 미치는 몇가지 요인에 관한 세포 생물학적 연구 (1) Serotonin의 영향

        최임순,주상옥,주충노,오억수,신길상 한국통합생물학회 1989 동물학회지 Vol.32 No.1

        Tryptophan 또는 serotonin을 계란에 투여하고 배양하였을 때의 초기 계배의 뇌형성에 미치는 영향을 관찰한 결과, 뇌의 신경세포는 핵막의 불규칙하고 핵응축현상이 심하며 염색질이 핵막에 응집되고 인도 분해되었으며 핵막이 팽출되어 생긴 수포가 형성되었다. 그리고 조면소포체와 골지체는 심하게 확장되어 있었고, 미토콘드리아는 팽윤화된 것이 많았으며 신경세관의 발달이 매우 미비하였다. 즉 이와 같은 현상은 특히 초기 1-2일간 배양 계배에서 극심하였다. Tryptophan 또는 serotonin을 투여한 후 18시간 배양한 배반엽의 간충 세포는 대조군에 비하여 세포질이 미숙하였고, 세포내 소기관이 크게 손상되어 있었으며 난황과립의 분해가 대조군에 비하여 지연되고 있음을 알 수 있었으며, 24-72시간 배양한 배반엽의 암대의 미세융모는 대조군에 비하여 현저하게 길이가 짧고 발달이 미비하였다. 또한 Tryptophan 또는 serotonin을 투여한 계배의 경우 배반엽의 크기, 투명대 및 배의 크기가 대조군에 비하여 작았으며, serotonin 처리군의 경우가 더욱 작았다. 또한 단백질 및 핵산 함량이 대조군에 비하여 훨씬 낮았고 tubulin 합성량도 크게 저하되었음이 확인되었다. 위와 같은 실험결과는 과량의 tryptophan 또는 serotonin이 난황과립 분해를 지연시켜 결과적으로 단백질 합성을 억제함으로서 tubulin합성이 저하되고, 이로 인하여 미세소관의 형성과 미세융모의 발달과 기능이 부진하여 형태형성에 이상을 초래하는 것으로 사료된다. The effect of tryptophan or serotonin on the early stage of chick brain development has been morphologically investigated using an electron microscope. The electron micrographs of neural plate cells of 1-day chick embryo treated with tryptophan or serotonin showed irregularity, evagination and disruption of nuclear membrane and nuclear chromatin condenstation, nucleolar margination and segregation. Hypertrophy of stalks, vesicles and vaculoes were seen and dilated and disrupted rough endoplasmic reticulum and underdeveloped neurotubules were also observed. In mesenchyme cells of tryptophan or serotonin administered 18 hr embryo, irregular nuclear membrane, swollen mitochondria, dilated rough endoplasmic reticulum and very large yolk granules were observed. Furthermore, DNA, RNA and protein contents of the embryos treated with typtophan or serotonin were considerably lower than those of control group. The amount of tubulin of the experimental groups was also greatly lower than that of control, suggesting that the impairment of microtubule formation occurred. Tryptophan or serotonin administration might depress the biosynthesis, of nucleic acid and protein including some enzymes tested. It seems that the serotonin formed from exogeneous tryptophan might inhibit the degradation of yolk granule by feedback regulation mechanism so as to impair microtububle and microvilli formation followed by a malformation of chick embryos.

      • KCI등재

        열충격 및 ${\alpha}$-amanitin과 cycloheximide의 처리를 통한 초기 계배의 체절 형성 기작에 대한 발생학적 연구

        최임순,박용빈,김옥용,Choe, Rim-Soon,Park, Yong-Bin,Kim, Ok-Yong 한국현미경학회 1991 Applied microscopy Vol.21 No.2

        In order to investigate the factors of the control mechanism of somitogenesis, early chick embryos (H-H stage $8{\sim}13$) were treated with heat shock, ${\alpha}$-amanitin and cycloheximide and morphological changes of somite were examined by light microscopy, transmission and scanning electron microscopy. In normal chick embryo, somites were formed from the somitomere which preexisted in segmental plate. Somites were wrapped with extracellular collagen fibrils and connected with neural tube, notochord and ectoderm. And then, somites were differentiated to sclerotome, dermatome and myotome by the interaction of nervous tissue. Abnormal somites were observed after formation of six or seven so mites in heat shock treated group. Amounts of collagen fibrils were obviously decreased in this group. In cycloheximide treated group, most so mites were smaller and neural tube formation was incomplete. Chromatins were condenced and formed several heterochromatins in the nucleus of somite cells. Lipid like cytoplasmic dense mass and lipid droplets were also observed. Segmentation of somites seemed to be normal progress in ${\alpha}$-amanitin treated group. Center of somite, however, hollowed in longitudinal sectioned samples. These results suggested that so mites were already existed in the segmental plate as the form of somitomere. Segmented somites were contacted with neural tube or notochord and the somites were tightly connected with each other by the extracellular collagen fibrils which were secreted from neuroepithelium and somite cells. Somites are thought to differentiate into sclerotome, dermatome and myotome by these interactions.

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