• The Journal of Korean Society for Radiation Therapy
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• v.28 no.1
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• pp.7-16
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• 2016

Purpose : This study aimed to compare and evaluate between the efficiency of two respective devices, 3D-bolus and step-bolus when the devices were used for the treatment of patients whose chest walls were required to undergo the electron beam therapy after the surgical procedure of modified radical mastectomy, MRM. Materials and Methods : The treatment plan of reverse hockey stick method, using the photon beam and electron beam, had been set for six breast cancer patients and these 6 breast cancer patients were selected to be the subjects for this study. The prescribed dose of electron beam for anterior chest wall was set to be 180 cGy per treatment and both the 3D-bolus, produced using 3D printer(CubeX, 3D systems, USA) and the self-made conventional step-bolus were used respectively. The surface dose under 3D-bolus and step-bolus was measured at 5 measurement spots of iso-center, lateral, medial, superior and inferior point, using GAFCHROMIC EBT3 film (International specialty products, USA) and the measured value of dose at 5 spots was compared and analyzed. Also the respective treatment plan was devised, considering the adoption of 3D-bolus and stepbolus and the separate treatment results were compared to each other. Results : The average surface dose was 179.17 cGy when the device of 3D-bolus was adopted and 172.02 cGy when step-bolus was adopted. The average error rate against the prescribed dose of 180 cGy was -(minus) 0.47% when the device of 3D-bolus was adopted and it was -(minus) 4.43% when step-bolus was adopted. It was turned out that the maximum error rate at the point of iso-center was 2.69%, in case of 3D-bolus adoption and it was 5,54% in case of step-bolus adoption. The maximum discrepancy in terms of treatment accuracy was revealed to be about 6% when step-bolus was adopted and to be about 3% when 3D-bolus was adopted. The difference in average target dose on chest wall between 3D-bolus treatment plan and step-bolus treatment plan was shown to be insignificant as the difference was only 0.3%. However, to mention the average prescribed dose for the part of lung and heart, that of 3D-bolus was decreased by 11% for lung and by 8% for heart, compared to that of step-bolus. Conclusion : It was confirmed through this research that the dose uniformity could be improved better through the device of 3D-bolus than through the device of step-bolus, as the device of 3D-bolus, produced in consideration of the contact condition of skin surface of chest wall, could be attached to patients' skin more nicely and the thickness of chest wall can be guaranteed more accurately by the device of 3D-bolus. It is considered that 3D-bolus device can be highly appreciated clinically because 3D-bolus reduces the dose on the adjacent organs and make the normal tissues protected, while that gives no reduction of dose on chest wall.

• Tuberculosis and Respiratory Diseases
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• v.44 no.4
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• pp.742-755
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• 1997

Background : Endobronchial tuberculosis(ET) is still relatively common disease in Korea. We intended to evaluate the length of endobronchial lesion, peribronchial thickness, luminal irregularity and associated mediastinal lymph node enlargement with Chest CT to get information for such aggressive treatment as electrocautery, laser therapy and so on of bronchial stricture in ET, and also to compare the change of Chest CT finding with that of bronchoscopic finding after one month of anti-tuberculosis treatment. Method : We performed CT in 26 patients who were diagnosed as ET by bronchoscopy at Boramae Hospital from November 1991 to March 1996. After classifying ET into seven subtypes according to bronchoscopic finding, we analyzed the CT finding of each subtype. And we followed up the bronchoscopy, CT, and PIT after one month of anti-tuberculosis treatment, and compared the change of CT findings with those of bronchoscopic findings in nine patients. Results : Age of the patients was from 17 to 73 years old, and the ratio of male to female was 1 : 25 with absolute female predominance. The site(s) of bronchial involvement by tuberculosis is one in 14 cases, two in nine cases and three in one case, respectively, and the left main bronchus was the most frequently involved site (13 cases for multiple involvements and 7 cases for single involvement among 26 cases). The length of bronchial involvement by tuberculosis which was measured by CT was from 10 to 55 mm, and there was a tendency that the length of involved lesion in fibrostenotic type was shorter than that of actively caseating type. Bronchial stricture on CT was noticed in 25 (96%) cases and the range of severity was from total occlusion to near-normal and also showed wide variation even though the subtype of ET was same. The increase of peribronchial thickness which was measured by CT, was noticed in 21 cases (91%) among 23 cases (in which the measurement was possible), and there was no improvement of peribronchial thickness in those cases which showed little improvement in bronchial stricture despite anti-tuberculosis treatment. There was no difference in the luminal irregularity of involved bronchi on CT in relation to bronchoscopic subtypes. The mediastinal lymph node enlargement, defined as the diameter of lymph node was larger than 1cm on CT, was detected in 20 cases (77%), and right side was more frequently involved (L : R = 1 : 5.2). The CT finding usually showed extrinsic bronchial compression but showed direct invasion in two cases which were bronchoscopically classified as tumorous type. When follow-up bronchoscopy and CT was performed after one month of anti-tuberculosis treatment in nine patients, CT showed significant improvement in peribronchial thickness and mediastinal lymph node enlargement. Bronchial stricture was also improved in 6 cases but aggravated in 3 cases despite anti-tuberculosis therapy. In two cases which were classified as fibrostenotic type by bronchoscopy, CT showed significant improvement in bronchial stricture, interestingly. Conclusion : We concluded that the role of Chest CT was complimentary to bronchoscopy in ET, since CT was useful in evaluating the length of bronchial involvement, peribronchial thickness, and mediastinal lymph node enlargement.

• The Korean Journal of Nuclear Medicine Technology
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• v.16 no.1
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• pp.80-85
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• 2012

Purpose: The whole body bone scan is an examination that visualizing physiological change of bones and using bone-congenial radiopharmaceutical. The patients are intravenous injected radiopharmaceutical which labeled with radioactive isotope ($^{99m}Tc$) emitting 140 keV gammarays and scanned after injection. The 3 principles of radiation protection from external exposureare time, distance and shielding. On the 3 principles of radiation protection basis, radiopharmaceutical might just as well be injected rapidly for reducing radiation because it might be the unopened radiation source. However the radiopharmaceuticals are injected into patient directly and there is a limitation of distance control. This study confirmed the change of radiation exposure as change of distance from radiopharmaceutical and observed the change of radiation exposure afte rsetting a shelter for help to control radio-technician's exposure. Materials & methods: For calculate the average of injection time, the trained injector measured the injection time for 50 times and calculated the average (2 minutes). We made a source as filled the 99mTc-HDP 925 MBq 0.2 mL in a 1 mL syringe and measured the radiation exposure from 50 cm,100 cm,150 cm and 200 cm by using Geiger-Mueller counter (FH-40, Thermo Scientific, USA). Then we settled a lead shielding (lead equivalent 6 mm) from the source 25 cm distance and measured the radiation exposure from 50 cm distance. For verify the reproducibility, the measurement was done among 20 times. The correlation between before and after shielding was verified by using SPSS (ver. 18) as paired t-test. Results: The radiation doses according to distance during 2 minutes from the source without shielding were $1.986{\pm}0.052{\mu}$ Sv in 50 cm, $0.515{\pm}0.022{\mu}$ Sv in 100 cm, $0.251{\pm}0.012{\mu}$ Sv in 150 cm, $0.148{\pm}0.006{\mu}$ Sv in 200 cm. After setting the shielding, the radiation dose was $0.035{\pm}0.003{\mu}$ Sv. Therefore, there was a statistical significant difference between the radiation doses with shielding and without shielding ($p$<0.001). Conclusion: Because the great importance of whole body bone scan in the nuclear medicine, we should make an effort to reduce radiation exposure during radiopharmaceutical injections by referring the principles of radiation protection from external exposure. However there is a limitation of distance for direct injection and time for patients having attenuated tubules. We confirmed the reduction of radiation exposure by increasing distance. In case of setting shield from source 25 cm away, we confirmed reducing of radiation exposure. Therefore it would be better for reducing of radiation exposure to using shield during radiopharmaceutical injection.

• The Korean Journal of Nuclear Medicine Technology
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• v.16 no.1
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• pp.115-118
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• 2012

Purpose: The Levey-Jennings chart controlled measurement values that deviated from the tolerance value (mean ${\pm}2SD$ or ${\pm}3SD$). On the other hand, the upgraded Westgard Multi-Rules are actively recommended as a more efficient, specialized form of hospital certification in relation to Internal Quality Control. To apply Westgard Multi-Rules in quality control, credible quality control substance and target value are required. However, as physical examinations commonly use quality control substances provided within the test kit, there are many difficulties presented in the calculation of target value in relation to frequent changes in concentration value and insufficient credibility of quality control substance. This study attempts to improve the professionalism and credibility of quality control by applying Westgard Multi-Rules and calculating credible target value by using a commercialized quality control substance. Materials and Methods : This study used Immunoassay Plus Control Level 1, 2, 3 of Company B as the quality control substance of Total T3, which is the thyroid test implemented at the relevant hospital. Target value was established as the mean value of 295 cases collected for 1 month, excluding values that deviated from ${\pm}2SD$. The hospital quality control calculation program was used to enter target value. 12s, 22s, 13s, 2 of 32s, R4s, 41s, $10\bar{x}$, 7T of Westgard Multi-Rules were applied in the Total T3 experiment, which was conducted 194 times for 20 days in August. Based on the applied rules, this study classified data into random error and systemic error for analysis. Results: Quality control substances 1, 2, and 3 were each established as 84.2 ng/$dl$, 156.7 ng/$dl$, 242.4 ng/$dl$ for target values of Total T3, with the standard deviation established as 11.22 ng/$dl$, 14.52 ng/$dl$, 14.52 ng/$dl$ respectively. According to error type analysis achieved after applying Westgard Multi-Rules based on established target values, the following results were obtained for Random error, 12s was analyzed 48 times, 13s was analyzed 13 times, R4s was analyzed 6 times, for Systemic error, 22s was analyzed 10 times, 41s was analyzed 11 times, 2 of 32s was analyzed 17 times, $10\bar{x}$ was analyzed 10 times, and 7T was not applied. For uncontrollable Random error types, the entire experimental process was rechecked and greater emphasis was placed on re-testing. For controllable Systemic error types, this study searched the cause of error, recorded the relevant cause in the action form and reported the information to the Internal Quality Control committee if necessary. Conclusions : This study applied Westgard Multi-Rules by using commercialized substance as quality control substance and establishing target values. In result, precise analysis of Random error and Systemic error was achieved through the analysis of 12s, 22s, 13s, 2 of 32s, R4s, 41s, $10\bar{x}$, 7T rules. Furthermore, ideal quality control was achieved through analysis conducted on all data presented within the range of ${\pm}3SD$. In this regard, it can be said that the quality control method formed based on the systematic application of Westgard Multi-Rules is more effective than the Levey-Jennings chart and can maximize error detection.

• The Korean Journal of Nuclear Medicine Technology
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• v.14 no.2
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• pp.21-25
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• 2010

Purpose: For better PET imaging with accuracy the transmission scanning is inevitably required for attenuation correction. The attenuation is affected by condition of acquisition and patient position, consequently quantitative accuracy may be decreased in emission scan imaging. In this paper, the present study aims at providing the measurement for attenuation varying with the positions of the patient's arm in whole body PET/CT, further performing the comparative analysis over its SUV changes. Materials and Methods: NEMA 1994 PET phantom was filled with $^{18}F$-FDG and the concentration ratio of insert cylinder and background water fit to 4:1. Phantom images were acquired through emission scanning for 4min after conducting transmission scanning by using CT. In an attempt to acquire image at the state that the arm of the patient was positioned at the lower of ahead, image was acquired in away that two pieces of Teflon inserts were used additionally by fixing phantoms at both sides of phantom. The acquired imaged at a were reconstructed by applying the iterative reconstruction method (iteration: 2, subset: 28) as well as attenuation correction using the CT, and then VOI was drawn on each image plane so as to measure CT number and SUV and comparatively analyze axial uniformity (A.U=Standard deviation/Average SUV) of PET images. Results: It was found from the above phantom test that, when comparing two cases of whether Teflon insert was fixed or removed, the CT number of cylinder increased from -5.76 HU to 0 HU, while SUV decreased from 24.64 to 24.29 and A.U from 0.064 to 0.052. And the CT number of background water was identified to increase from -6.14 HU to -0.43 HU, whereas SUV decreased from 6.3 to 5.6 and A.U also decreased from 0.12 to 0.10. In addition, as for the patient image, CT number was verified to increase from 53.09 HU to 58.31 HU and SUV decreased from 24.96 to 21.81 when the patient's arm was positioned over the head rather than when it was lowered. Conclusion: When arms up protocol was applied, the SUV of phantom and patient image was decreased by 1.4% and 9.2% respectively. With the present study it was concluded that in case of PET/CT scanning against the whole body of a patient the position of patient's arm was not so much significant. Especially, the scanning under the condition that the arm is raised over to the head gives rise to more probability that the patient is likely to move due to long scanning time that causes the increase of uptake of $^{18}F$-FDG of brown fat at the shoulder part together with increased pain imposing to the shoulder and discomfort to a patient. As regarding consideration all of such factors, it could be rationally drawn that PET/CT scanning could be made with the arm of the subject lowered.

• The Journal of Korean Society for Radiation Therapy
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• v.24 no.2
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• pp.123-135
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• 2012

Purpose: It is essential to minimize the movement of tumor due to respiratory movement at the time of respiration controlled radiotherapy of non-small cell lung cancer patient. Accordingly, this Study aims to evaluate the usefulness of restricted respiratory period by comparing and analyzing the treatment plans that apply free and restricted respiration period respectively. Materials and Methods: After having conducted training on 9 non-small cell lung cancer patients (tumor n=10) from April to December 2011 by using 'signal monitored-breathing (guided- breathing)' method for the 'free respiratory period' measured on the basis of the regular respiratory period of the patents and 'restricted respiratory period' that was intentionally reduced, total of 10 CT images for each of the respiration phases were acquired by carrying out 4D CT for treatment planning purpose by using RPM and 4-dimensional computed tomography simulator. Visual gross tumor volume (GTV) and internal target volume (ITV) that each of the observer 1 and observer 2 has set were measured and compared on the CT image of each respiratory interval. Moreover, the amplitude of movement of tumor was measured by measuring the center of mass (COM) at the phase of 0% which is the end-inspiration (EI) and at the phase of 50% which is the end-exhalation (EE). In addition, both observers established treatment plan that applied the 2 respiratory periods, and mean dose to normal lung (MDTNL) was compared and analyzed through dose-volume histogram (DVH). Moreover, normal tissue complication probability (NTCP) of the normal lung volume was compared by using dose-volume histogram analysis program (DVH analyzer v.1) and statistical analysis was performed in order to carry out quantitative evaluation of the measured data. Results: As the result of the analysis of the treatment plan that applied the 'restricted respiratory period' of the observer 1 and observer 2, there was reduction rate of 38.75% in the 3-dimensional direction movement of the tumor in comparison to the 'free respiratory period' in the case of the observer 1, while there reduction rate was 41.10% in the case of the observer 2. The results of measurement and comparison of the volumes, GTV and ITV, there was reduction rate of $14.96{\pm}9.44%$ for observer 1 and $19.86{\pm}10.62%$ for observer 2 in the case of GTV, while there was reduction rate of $8.91{\pm}5.91%$ for observer 1 and $15.52{\pm}9.01%$ for observer 2 in the case of ITV. The results of analysis and comparison of MDTNL and NTCP illustrated the reduction rate of MDTNL $3.98{\pm}5.62%$ for observer 1 and $7.62{\pm}10.29%$ for observer 2 in the case of MDTNL, while there was reduction rate of $21.70{\pm}28.27%$ for observer 1 and $37.83{\pm}49.93%$ for observer 2 in the case of NTCP. In addition, the results of analysis of correlation between the resultant values of the 2 observers, while there was significant difference between the observers for the 'free respiratory period', there was no significantly different reduction rates between the observers for 'restricted respiratory period. Conclusion: It was possible to verify the usefulness and appropriateness of 'restricted respiratory period' at the time of respiration controlled radiotherapy on non-small cell lung cancer patient as the treatment plan that applied 'restricted respiratory period' illustrated relative reduction in the evaluation factors in comparison to the 'free respiratory period.

• Korean Journal of Agricultural Science
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• v.2 no.2
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• pp.357-373
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• 1975

This study was conducted to evaluate the winter active polycross progenies of 10 genotypes selected at the hot and dry climate of the Southern Oregon in their performance in the progeny test comparing with a high yielding variety, 'Fawn', and a winter active variety, 'TFM', as the control varieties at Daejon, Korea. Various plant and leaf characteristics, especially which related to photosynthesis, and forage production during the first summer after their establishment, were examined. The important conclusions of this study are summarized as follows: 1. The winter active genotypes and variety had less leaf fresh weight and dry weight per leaf than variety 'Fawn'. Variations among polycross progenies of genotypes for these characteristics were great. 2. The winter active genotypes and variety had less leaf area per leaf than variety 'Fawn'. Leaf area among polycross progenies of genotypes deviated greatly and poly cross progenies of 'genotype-16' had the same average leaf area as 'Fawn'. 3. Differences of specific leaf weight (S. L. W.) in the winter active genotypes and variety were not significant. Probably the genetic diversity for S. L. W were not big and were narrowed down already in this genetic population. It was suggested that the photosynthate production within the population might not be different and there might be differences in the photosynthate production-translocation balance. Further study for the diurnal change in S. L. W. within the population might be useful. 4. The winter active variety and genotypes had less leaf width than 'Fawn' does. Leaf width among polycross progenies of genotypes deviated significantly. 5. Differences among controls and polycross progeny group in the initial plant height were significant and variety 'Fawn' was taller than the winter active genotypes and variety. But the differences were not significant in the regrowth of plant height after the first forage harvest. On the contrary. the differences among polycross progenies of genotypes were not significant in the initial plant but the differences in their polycross progeny performance became obvious and great in the regrowth ability which is an improtent agronomic characteristics for forage crops produced in the pasture and for hay and silage. 6. Plant width of the winter active genotypes and variety was lesser than 'Fawn' variety. 7. Differences of tiller number became evident and variety 'Fawn' had higher tiller number than the winter active genotypes and variety after the first forage cutting. There, deviations among polycross progenies of genotypes were great for this characteristic. It was obvious that the genetic differences became more evident in the second measurement after the first cutting of forage probably because this characteristic were stimulated by defoliation in the cartain genotypes and variety. 8. The winter active genotypes and variety on the initial growth. the regrowth ability andtotal yield had lesser forage yield than variety 'Fawn'. Deviation of forage yield among polycross progenies of genotypes were great and gave basis for selection according to their polycross progeny performance improving the forage yield of these winter active tall fescue population during summer. 9. It was concluded that the winter active variety and genotypes in this study was poorer than variety 'Fawn' for the most of leaf and plant characteristics including forage yield. For these measurements, the variations among polycross progenies of genotypes were great. and plant breeding might able to improve further this winter active tall fescue through the polycross progeny testing method for the higher forage production during summer in Korea. 10. The result of the associations among various characteristics under study were quite agreeable with the results of the analysis of variance and woul be useful in the selection of desirable genotypes for the development of a new variety.

• The Korean Journal of Nuclear Medicine
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• v.38 no.3
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• pp.259-267
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• 2004

Purpose: NEMA NU2-2001 was proposed as a new standard for performance evaluation of whole body PET scanners. in this study, system performance of Siemens CTI ECAT EXACT 47 PET scanner including spatial resolution, sensitivity, scatter fraction, and count rate performance in 2D and 3D mode was evaluated using this new standard method. Methods: ECAT EXACT 47 is a BGO crystal based PET scanner and covers an axial field of view (FOV) of 16.2 cm. Retractable septa allow 2D and 3D data acquisition. All the PET data were acquired according to the NEMA NU2-2001 protocols (coincidence window: 12 ns, energy window: $250{\sim}650$ keV). For the spatial resolution measurement, F-18 point source was placed at the center of the axial FOV((a) x=0, and y=1, (b)x=0, and y=10, (c)x=70, and y=0cm) and a position one fourth of the axial FOV from the center ((a) x=0, and y=1, (b)x=0, and y=10, (c)x=10, and y=0cm). In this case, x and y are transaxial horizontal and vertical, and z is the scanner's axial direction. Images were reconstructed using FBP with ramp filter without any post processing. To measure the system sensitivity, NEMA sensitivity phantom filled with F-18 solution and surrounded by $1{\sim}5$ aluminum sleeves were scanned at the center of transaxial FOV and 10 cm offset from the center. Attenuation free values of sensitivity wire estimated by extrapolating data to the zero wall thickness. NEMA scatter phantom with length of 70 cm was filled with F-18 or C-11solution (2D: 2,900 MBq, 3D: 407 MBq), and coincidence count rates wire measured for 7 half-lives to obtain noise equivalent count rate (MECR) and scatter fraction. We confirmed that dead time loss of the last flame were below 1%. Scatter fraction was estimated by averaging the true to background (staffer+random) ratios of last 3 frames in which the fractions of random rate art negligibly small. Results: Axial and transverse resolutions at 1cm offset from the center were 0.62 and 0.66 cm (FBP in 2D and 3D), and 0.67 and 0.69 cm (FBP in 2D and 3D). Axial, transverse radial, and transverse tangential resolutions at 10cm offset from the center were 0.72 and 0.68 cm (FBP in 2D and 3D), 0.63 and 0.66 cm (FBP in 2D and 3D), and 0.72 and 0.66 cm (FBP in 2D and 3D). Sensitivity values were 708.6 (2D), 2931.3 (3D) counts/sec/MBq at the center and 728.7 (2D, 3398.2 (3D) counts/sec/MBq at 10 cm offset from the center. Scatter fractions were 0.19 (2D) and 0.49 (3D). Peak true count rate and NECR were 64.0 kcps at 40.1 kBq/mL and 49.6 kcps at 40.1 kBq/mL in 2D and 53.7 kcps at 4.76 kBq/mL and 26.4 kcps at 4.47 kBq/mL in 3D. Conclusion: Information about the performance of CTI ECAT EXACT 47 PET scanner reported in this study will be useful for the quantitative analysis of data and determination of optimal image acquisition protocols using this widely used scanner for clinical and research purposes.

• Korean Journal of Agricultural Science
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• v.9 no.1
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• pp.284-302
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• 1982

Development of protein resources as food has been a big issue especially in Southeast Asia region, and intake of protein is also insufficient in Korea. To cope with this shortage of protein resources and its improvement together with increased production of high nutritive animal protein, studies were carried out on feeding of Korean native goats. In the experiments were made absorption of carbohydrate and volatile fatty acid in miniature rumen, and absorption of amino acid in rumen as in vivo were conducted as part of studies on nutritional absorption in rumen. Those nutritional for improvement of feeding and management as described above are summarized as following. 1. According to the result of test on the nutritional absorption of native goat by means of miniature rumen method, absorption ratio of VFA measured at 0.5, 1 and 2 hours after injection of nutrition showed propionic acid 70-86%, acetic acid 74-87%, and lactic acid 76-89%. In the absorption of organic substances, ethyl alcohol of 0.5% showed 29-87% and lactic acid of 0.1M showed 12-27% of absorption ratio. 2. Result of absorption measurement in rumen from L-type free amino acid injection in the content of rumen vein showed lower rate at menthionine-free group compared to whole-egg amino acid injection in the content of rumen vein showed lower rate at methioine-free group compared to whole-egg amino acid group, and high absorption ratio was observed at methionine 3 times group and urea added group. Deficiency of methionine caused no change of the content in mucous membranes. 3. Absorption of amino acid in rumen muscular layer showed equal tendency as in the mucous membrane without exerting any influence of methionine deficiency. At the methionine3-times group, content of methionine and glutamine were increased by 14.7 and 4.4 times as compared to whole-egg amino acid group, an absorption ratio of glutamine, proline and valine were increased at urea added group. 4. In general, concentration of amino acid in rumen vein plasma was lower than in rumen mucous membrane and muscular layer. Absorption ratio of amino acid is decreased due to methionine deficiency, and tripling of methionine or urea adding caused increment of amino acid. Absorption pattern is thus varied depending on the composition of amino acid. 5. At the urea added group, content of ammonia-N, amino-N and urea were increased in rumen muscular layer. As the inside of goat's rumen was unable to clean thoroughly, investigation was made on remaining bacteria, however, variation of ammonia-N was affected by these bacterial content. 6. Variation in rumen structure by differential absorption of amino acid was observed by general microscope and fluorescent microscope. According to the result of observation in the methionine 3 times group, single cylinder epithelium of mucous membrane showed rather thin, and it was thick at urea added group though no significant differences existed among test groups in submucous membrane and muscular layer.

• Journal of Dairy Science and Biotechnology
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• v.34 no.2
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• pp.99-116
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• 2016

We herein performed animal safety assessment in accordance with Good Laboratory Practice (GLP) regulations with the aim of developing sialic acid from glycomacropeptide (hereafter referred to as "GMP") as an index ingredient and functional component in functional foods. GMP is a type of whey protein derived from milk and a safe food, with multiple functions, such as antiviral activity. A test substance was produced containing 7% (w/w) sialic acid and mostly-hydrolyzed whey protein (hereafter referred to as "7%-GNANA") by enzymatic treatment of substrate GMP. The maximum intake test dose level was selected based on 5,000 mg/kg/day dose set for male NOEL (no-observed-effect-level) and female NOAEL (no-observed-adverse-effect-level) determined by a dose-range finding (DRF) test (GLP Center of Catholic University of Daegu, Report No. 15-NREO-001) that was previously conducted with the same test substance. To evaluate the toxicity of a repeated oral dose of the test substance in connection with the previous DRF study, 1,250, 2,500, and 5,000 mg/kg of the substance were administered by a probe into the stomachs of 6-week-old SPF Sprague-Dawley male and female rats for 90 d. Each test group consisted of 10 male and 10 female rats. To determine the toxicity index, all parameters, such as observation of common signs; measurements of body weight and food consumption; ophthalmic examination; urinalysis, electrolyte, hematological, and serum biochemical examination; measurement of organ weights during autopsy; and visual and histopathological examinations were conducted according to GLP standards. After evaluating the results based on the test toxicity assessment criteria, it was determined that NOAEL of the test substance, 7%-GNANA, was 5,000 mg/kg/day, for both male and female rats. No animal death was noted in any of the test groups, including the control group, during the study period, and there was no significant difference associated with test substance, as compared with the control group, with respect to general symptoms, body weight changes, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemical examination, and electrolyte and blood coagulation tests during the administration period (P<0.05). As assessed by the effects of the test substance on organ weights, food consumption, autopsy, and histopathological safety, change in kidney weight as an indicator of male NOAEL revealed up to 20% kidney weight increase in the high-dose group (5,000 mg/kg/day) compared with the change in the control group. However, it was concluded that this effect of the test substance was minor. In the case of female rats, reduction of food consumption, increase of kidney weight, and decrease of thymus weight were observed in the high-dose group. The kidney weight increased by 10.2% (left) and 8.9% (right) in the high-dose group, with a slight dose-dependency compared with that of the control group. It was observed that the thymus weight decreased by 25.3% in the high-dose group, but it was a minor test substance-associated effect. During the autopsy, botryoid tumor was detected on the ribs of one subject in the high-dose group, but we concluded that the tumor has been caused by a naturally occurring (non-test) substance. Histopathological examination revealed lesions on the kidney, liver, spleen, and other organs in the low-dose test group. Since these lesions were considered a separate phenomenon, or naturally occurring and associated with aging, it was checked whether any target organ showed clear symptoms caused by the test substance. In conclusion, different concentrations of the test substance were fed to rats and, consequently, it was verified that only a minor effect was associated with the test substance in the high-dose (5,000 mg/kg/day) group of both male and female rats, without any other significant effects associated with the test substance. Therefore, it was concluded that NOAEL of 7%-GNANA (product name: Helicobactrol) with male and female rats as test animals was 5,000 mg/kg/day, and it thus was determined that the substance is safe for the ultimate use as an ingredient of health functional foods.