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Critical Essay on the Notice of the Price Adjustment of Generic Drugs (제네릭 의약품 약가 조정 고시에 대한 비판적 고찰)

  • Park, Jeong Yeon
    • The Korean Society of Law and Medicine
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    • v.22 no.1
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    • pp.91-124
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    • 2021
  • In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

Clinical Result of a Staged Reimplantation of Fungus Related Periprosthetic Joint Infection after Total Knee Arthroplasty (슬관절 전치환술 후 인공관절 주위 진균 감염의 임상적 결과)

  • Kim, Hyung Joo;Bae, Ki Cheor;Min, Kyung Keun;Choi, Hyeong Uk
    • Journal of the Korean Orthopaedic Association
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    • v.54 no.1
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    • pp.52-58
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    • 2019
  • Purpose: Fungal periprosthetic joint infection (PJI) is a rare but devastating complication following total knee arthroplasty (TKA). On the other hand, a standardized procedure regarding an accurate treatment of this serious complication of knee arthroplasty is lacking. The clinical progress of staged reimplantation in patients who had fungus-related PJI after TKA was reviewed retrospectively. Materials and Methods: Ten patients who had a fungal related PJI after TKA between 2006 and 2017 using staged reimplantation surgery were reviewed. These patients were compared with 119 patients who had a PJI in the same period. The failure rate of infection control, intravenous antimicrobial using the period, and the clinical results were evaluated by comparing the range of motion and Korean knee score (KKS) between pre-staged reimplantation and the last follow-up. Results: In the fungal infection group, 7 out of 10 cases (70.0%) had failed in infection control using staged reimplantation and in the non-fungal group, 7 out of 119 cases (5.9%) had failed (p=0.04). In the non-fungal group, the mean duration of antibiotics was 6.2 weeks. In the fungus group, the mean duration of antibiotics was 15.3 weeks, which was 9.1 weeks longer (p<0.001). The range of motion of the knee was increased in the two groups (p=0.265). At the last follow-up, the KKS was 71.01 points in the non-fungal group and 61.3 points in the fungal group (p=0.012). Erythrocyte sedimentation rate and C-reactive protein (CRP) decreased in the two groups, but the CRP was significantly different in the two groups (p=0.007). Conclusion: The treatment of fungus-related PJIs using staged reimplantation showed uneven clinical progress and unsatisfactory clinical improvements compared to non-fungal PJI. Therefore, it is necessary to consider the use of an antifungal mixed cement spacer at resection arthroplasty and oral antifungal agent after reimplantation.

Suggestions on Expanding Admission Number of Medical School (의과대학 정원 확대에 대한 제언)

  • Eun-Cheol Park
    • Health Policy and Management
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    • v.34 no.2
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    • pp.120-128
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    • 2024
  • From February to now 2024, there continues to be controversy over the expansion of admission number to medical school. Some of the controversy arises from a mix of present and future time points. In the present time point, the controversy over whether physicians are some shortages or not has various aspects. Some aspects are presented as evidence of the physician shortage and others as non-shortage. Also, the presenting evidence of shortage is being disputed, and so is the evidence of the contrary. This controversy over whether there is a shortage or not in the present time point makes it difficult to reach a consensus. In 10 years, the shortage of doctors will increase due to the rapid increase in the elderly population, so the admission number of medical schools will need to be increased. However, the increase must be such that there is minimal deterioration in the quality of medical education. More admission numbers should be allocated to medical schools with a high quality of medical education. This study suggests that large-scale medical schools increase the admission number by 20%-30%, and small-scale medical schools increase the admission number by 40%-50%, if so, the total increasing number is 760 to 1,066. If the 2,000-person increase is enforced, the quality of medical education must be carefully evaluated and the results should be reflected in adjusting the admission number of medical schools. In 20 years later, the admission number of medical schools will have to be reduced. This is because the physician supply is changing to a linear function and the physician demand (medical care demand) is changing to a quadratic function. Even if the current number is maintained, there will be an excess of doctors from 2048, so the medical school admission number must be reduced and its size will be reduced to about 2,000, a 30% reduction from the current number. Because the same reduction rate for all medical schools will result in many small-scale medical schools, the M&A (mergers and acquisitions) strategy should be considered with 40 medical schools and 12 Korean medical schools. In Korea, the main contributor to estimating physician demand is the change in population structure. Due to the rapid decrease in the total fertility rate, future population projections are uncertain. The recent rapid increase in healthcare utilization should be reexamined in the forecasting of physician demand. Since the various factors that affect the estimate of doctor supply and demand are unclear, the estimate of physician supply and demand must be continuously conducted every five years, and the Health Care Workforce Committee must be established and operated. The effects of increasing the admission number of medical schools should be evaluated and adjusted annually.

Postmortem Changes of the Protein and Amino Acid Composition of Muscles in the Partially Frozen Prawn, Pandalus japonica (보리새우육의 부분동결저장중 단백질 및 아미노산의 조성변화)

  • PYEUN Jae-Hyeung;CHOI Young-Joon;KIM Jeung-Han;CHO Kweon-Ock
    • Korean Journal of Fisheries and Aquatic Sciences
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    • v.17 no.4
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    • pp.280-290
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    • 1984
  • An extensive study has been made on the relationship between the freshness and the compositions of the muscle protein of prawn, Pandalus japonica during the storage under partially frozen condition. The variations of the subunit distribution for sarcoplasmic protein and myofibrillar protein extracted from the samples by changes of freshness were discussed by sodium dodecylsulfate-poly-acrylamide gel (SDS-PAG) electrophoresis. On the other hand, the denaturation constant ($K_D$) of the myofibrillar protein extracted from the prawn stored at $-3^{\circ}C\;and\;-20^{\circ}C$ were successively compared. The prawn muscle contained about $18\%$ of protein with the composition of $32\%$ in sarcoplasmic protein, $56\%$ in myofibrillar protein, $10\%$ in residual intracellular protein and $2\%$ in stroma. The indices for estimating freshness of the muscle were approached to the early stage of putrefaction on the 26th day of the storage with $25.29mg\%$ of total volatile basic nitrogen, $31.36\%$ of K-value and 8.83 of pH. The content of the myofibrillar protein was remarkably decreased with the time during the storage while that of residual intracellular protein was increased. The $K_D$ values of the myofibrillar protein were $9.03{\times}10^{-6}sec^{-1}\;at\;-3^{\circ}C\;and\;4.42{\times}10^{-6}sec^{-1}\;at\;-20^{\circ}C$. The results of the analysis of SDS-PAG electrophoretograms indicated that the sarcoplasmic protein and the myofibrillar protein were composed of 12 subunits and 17 subunits in the muscle of instantaneously killed prawn ana were changed into 8 subunits and 22 subunits in the muscle stored for 26 days, respectively. It is noticeable that 30,000, 41,000, 107,000, 136,000, 170,000 173,000, 185,000, and 198,000 daltons of the newly appeared 8 subunits were found in the myofibrillar protein from the prawn muscle stored for 26 days. The amino acid composition of the muscle protein showed that the most of amino acids were slightly decreased with the days of the storage. With respect to the free amino acid composition of the muscle of instantaneously killed prawn, glycine, proline, arginine, alanine and taurine comprised $93\%$ of the total free amino acids. Taurine, valine, leucine, phenylalanine, serine, lysine, methionine, isoleucine and histidine were increased during the storage period but exceptionally proline was decreased.

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The Market Segmentation of Coffee Shops and the Difference Analysis of Consumer Behavior: A Case based on Caffe Bene (커피전문점의 시장세분화와 소비자행동 차이 분석 : 카페베네 사례를 중심으로)

  • Yu, Jong-Pil;Yoon, Nam-Soo
    • Journal of Distribution Science
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    • v.9 no.4
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    • pp.5-13
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    • 2011
  • This study provides analysis of the effectiveness of domestic marketing strategies of the Korean coffee shop "Caffe Bene". It bases its evaluation on statistical outputs of 'choice attributes,' "market segmentation," demographic characteristics," and "satisfaction differences." The results are summarized in four points. First, five choice attributes were extracted from factor analysis: price, atmosphere, comfort, taste, and location; these are related to coffee shop selection behavior. Based on these five factors, cluster analysis was conducted, with statistical results classifying customers into three major groups: atmosphere oriented; comfort oriented; and taste oriented. Second, discriminant analysis tested cluster analysis and showed two discriminant functions: location and atmosphere. Third, cross-tabulation analysis based on demographic characteristics showed distinctive demographic characteristics within the three groups. Atmosphere oriented group, early-20s, as women of all ages was found to be 'walking down the street 'and 'through acquaintances' in many cases, as the cognitive path, and mostly found the store through 'outdoor advertising', and 'introduction'. Comfort oriented group was mainly women who are students in their early twenties or professionals, and appeared as a group to be very loyal because of high recommendation to other customers compared to other groups. Taste oriented group, unlike the other group, was mainly late-20s' college graduates, and was confirmed, as low loyalty, with lower recommendation activity. Fourth, to analyze satisfaction differences, one-way ANOVA was conducted. It shows that groups which show high satisfaction in the five main factors also show high menu satisfaction and high overall satisfaction. This results show that segmented marketing strategies are necessary because customers are considering price, atmosphere, comfort, taste, location when they choose coffee shop and demographics show different attributes based on segmented groups. For example, atmosphere oriented group is satisfied with shop interior and comfort while dissatisfied with price because most of the customers in this group are early 20s and do not have great financial capability. Thus, price discounting marketing strategies based on individual situations through CRM system is critical. Comfort oriented group shows high satisfaction level about location and shop comfort. Also, in this group, there are many early 20s female customers, students, and self-employed people. This group customers show high word of mouth tendency, hence providing positive brand image to the customers would be important. In case of taste oriented group, while the scores of taste and location are high, word of mouth score is low. This group is mainly composed of educated and professional many late 20s customers, therefore, menu differentiation, increasing quality of coffee taste and price discrimination is critical to increase customers' satisfaction. However, it is hard to generalize the results of study to other coffee shop brand, because this study have researched only one domestic coffee shop, Caffe Bene. Thus if future study expand the scope of locations, brands, and occupations, the results of the study would provide more generalizable results. Finally, research of customer satisfactions of menu, trust, loyalty, and switching cost would be critical in the future study.

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A Therapeutic Effect of Ozonated Oil on Bovine Mastitis (젖소 유방염에 대한 Ozonated oil의 치료효과)

  • Jo Sung-Nam;Liu Jianzhu;Lee Sang-Eun;Hong Min-Sung;Kim Duck-Hwan;Kim Myung-Cheol;Cho Sung-Whan;Jun Moo-Hyung
    • Journal of Veterinary Clinics
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    • v.22 no.4
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    • pp.318-321
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    • 2005
  • Forty- nine quarters from 24 lactating cows with chronic mastitis were selected. The cows were raised on dairy farms in Gongju, Jochiwon and Yeongi in Chungnam province, and Iksan in Jeonbuk province, Korea. The 49 quarters with bovine mastitis were divided into control (7 quarters) and experimental (42 quarters) groups. The experimental quarters were assigned to experimental group A (10 quarters, somatic cell count: $50-100\times10^4/ml)$, experimental group B (14 quarters, somatic cells count: $100-300{\times}10^4/ml)$, and experimental group C (18 quarters, somatic cells count: $>300\times10^4/ml$), according to the number of the somatic cells in their milk. The quarters of control group were treated with norfloxacin ointment (10 g/tube) based on the result of sensitivity, twice a day for 3 days. The quarters or experimental groups were infused 10ml or ozonated oils twice a day for 3 days. After treatment, the milk of the control group contained non-significantly lower numbers of somatic cells and bacteria on day 7, compared with pretreatment levels. Experimental groups A, B and C had lower somatic and bacterial cells in their milk on day 7, compared with pretreatment levels. Experimental group B and C had significantly lower numbers of somatic cells in their milk ell day 7 than before treatment (p<0.01). However, no significant difference in somatic cell numbers was detected between the control alld experimental groups. It was concluded that ozone therapy with ozonated oil applied on bovine mastitis might be effective.

Middle-aged Women's Health Behavior and Its related Factors in Rural Area (농촌 중년여성의 건강행위와 관련요인)

  • Kim, Kwi-Jin;Park, Jae-Yong;Han, Chang-Hyun
    • Journal of agricultural medicine and community health
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    • v.26 no.1
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    • pp.81-103
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    • 2001
  • This study was conducted to identify the health behavior of middle-aged rural women and the factors that have an effect on them. For the purpose of the study, examinations were made from March 01, 2000 to March 31, 2000 with 468 women aged 40 to 64 out of 2,263 people whom four Primary Health Posts located in Yechon County, Kyongsangbuk-do Province, are in charge of. The results are summarized as follows. 17.5% of the subjects responded that the extent of their own interest in health were high. For the subjects having a chronic disease, a nuclear family, or an open family atmosphere, the extent appeared to be relatively higher, 15.4% responded that the extent of family's interest in their health was high. It was significantly high if the extent of education was high or if the family atmosphere was open. The subjects' average score of self-efficacy was 49.9 out of 68. The score significantly varied depending on religion, education, living together with a spouse or not, and the extent of the subjects' interest in health. The family pattern, family atmosphere, family's interest in the subjects' health were the variables that significantly influenced the self-efficacy. The average score of family function was 5.51 out of 10. The score significantly varies depending on age, education, occupation, financial status, the extent of the subjects' own interest in health, family atmosphere and family's interest in the subjects' health. In the practice of health behavior, the nonsmoking rate was 89.5%, the nondrinking rate 63.0%, the rate of exercising practice 6.6%, the rate of normal sleeping 75.6%, the rate of eating breakfast 91.7%, the rate of not eating between meals 18.2%, and the standard BMI 69.2%. In the frequency of health behavior, the subjects with the Breslow Index of 0-3, 4-5 and 6-7 accounted for 4.5%, 53.2%, and 42.3%, respectively. The average score of health behavior was 5.20 out of 7, in which significant variables were living together with a spouse or not, financial status, absence or presence of a chronic disease, and family atmosphere. In the multiple regression analysis with health behavior as a dependent variable, it was shown that living together with a spouse or not, financial status, and family atmosphere were the significantly substantial variables. The subjects were found to do health behavior well if they had not a spouse, a good financial status, or an open family atmosphere. They were also found to do health behavior well if the extent of self-efficacy was high or if the extent of family function was low, but these were not the significant variables. It is needed to develop a standard measuring tool fit for our environment and perform more studies in the future because the measuring tool used in this study was a tool developed in a foreign county. In promoting community health projects, it is required not to provide all community people with a uniform health program but to identify the health behavior of individuals and other variables such as living together with a spouse or not, financial status and family atmosphere before arranging for a proper health program.

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Chinese relationship between animation and best pole - Focused on the aesthetic principles of the Cultural Revolution period (중국 애니메이션과 모범극의 상관관계 연구 - 문화대혁명 시기의 미학 원칙을 중심으로)

  • Kong, De Wei
    • Cartoon and Animation Studies
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    • s.39
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    • pp.215-231
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    • 2015
  • The Cultural Revolution in the history of Chinese animation hinder the development of the initial animation, and after a negative assessment instrument provided the cause is to become sluggish growth of the Chinese animation. So this time animation are things that are the subject of academic research studies or analysis has been depreciating almost uniformly without evaluation. However, of all the cultural and artistic creation it is developing in its own specific historical conditions and has the aesthetic results. This paper puts the primary purpose is to hold in consideration the aesthetic principles that led to cultural and artistic creativity and objective perspective the achievements the Chinese animation of the time period of the Cultural Revolution. Cultural Revolution is avoided to the previous period in accordance with the socialist ideology of Mao Ze-dong(毛澤東) sikindaneun highlight the culture of the proletariat and placed our goal to create a new class culture. Therefore, cultural and artistic creation of this period is often inconsistent with this part of our aesthetic principles generally accepted character has a non- elitist and anti properties. Best drama is a creative one hand as a model to implement the principles of aesthetics, art and culture Cultural Revolution period kkophimyeo reference for understanding the aesthetic principles that animated the Chinese Cultural Revolution period of orientation. This paper has San Tu Chu(三突出), Hong Guang Liang(紅光亮), and Gao Da Quan(高大全) at the time of the Cultural Revolution aesthetic principles are reflected in how the concrete work, the Cultural Revolution when the animation is how to accommodate these aesthetic principles and placed emphasis on comparative studies on best pole and correlation of the Cultural Revolution when the Chinese animation to ensure that adaptation in own way. First, after analyzing whether the aesthetic principles of focusing on the similarities of the best pole time of the Cultural Revolution and China, and how to implement animation in the works, these aesthetic principles according to the analysis of positive and negative influence on the creation of Chinese animation It was described as neutral. The detailed analysis and comparative study courses were trying to access in two significant aspects of the characters and scenes directing. In terms of character animation of the Cultural Revolution in China when a young boy or girl, emphasis should emphasize the health tinged with red lips and cheek blush to highlight the desired Gong Nong Bing(工農兵) shape as the main character and smooth texture and sophisticated highlights the glittering feeling to the touch, it was confirmed focused hayeoteum to implement the principle of 'Hong Guang Liang', highlighting the brilliant colors with a clean, bright colors. Highlighting a number of protagoniste compared to the antagonist in the animated scene of the Cultural Revolution a few times in terms of production and, among a number of protagoniste also emphasizes the outstanding hero figure, "yet three outstanding heroes heroic figures also emphasize the leading figures among the the director of the extrusion step-by-step approach "('San Tu Chu')was used. In addition, the hero figure is generally high and low angle by directing a large and perfect aesthetic appearance was to faithfully implement the principle of 'high-charged'('Gao Da Quan').

Development of Analytical Method for Detection of Fungicide Validamycin A Residues in Agricultural Products Using LC-MS/MS (LC-MS/MS를 이용한 농산물 중 살균제 Validamycin A의 시험법 개발)

  • Park, Ji-Su;Do, Jung-Ah;Lee, Han Sol;Park, Shin-min;Cho, Sung Min;Shin, Hye-Sun;Jang, Dong Eun;Cho, Myong-Shik;Jung, Yong-hyun;Lee, Kangbong
    • Journal of Food Hygiene and Safety
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    • v.34 no.1
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    • pp.22-29
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    • 2019
  • Validamycin A is an aminoglycoside fungicide produced by Streptomyces hygroscopicus that inhibits trehalase. The purpose of this study was to develop a method for detecting validamycin A in agricultural samples to establish MRL values for use in Korea. The validamycin A residues in samples were extracted using methanol/water (50/50, v/v) and purified with a hydrophilic-lipophilic balance (HLB) cartridges. The analyte was quantified and confirmed by liquid chromatograph-tandem mass spectrometer (LC-MS/MS) in positive ion mode using multiple reaction monitoring (MRM). Matrix-matched calibration curves were linear over the calibration ranges (0.005~0.5 ng) into a blank extract with $R^2$ > 0.99. The limits of detection and quantification were 0.005 and 0.01 mg/kg, respectively. For validation validamycin A, recovery studies were carried out three different concentration levels (LOQ, $LOQ{\times}10$, $LOQ{\times}50$, n = 5) with five replicates at each level. The average recovery range was from 72.5~118.3%, with relative standard deviation (RSD) less than 10.3%. All values were consistent with the criteria ranges requested in the Codex guidelines (CAC/GL 40-1993, 2003) and the NIFDS (National Institute of Food and Drug Safety) guideline (2016). Therefore, the proposed analytical method is accurate, effective and sensitive for validamycin A determination in agricultural commodities.

A Study on Anjoon-gut Music in Daejeon - Focused on Sir Shin Seok-bong's Antaek-gut Music- (대전의 앉은굿 음악 연구 - 신석봉 법사의 안택굿을 중심으로 -)

  • Park, Hye-jeong
    • Korean Journal of Heritage: History & Science
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    • v.38
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    • pp.5-42
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    • 2005
  • Based on a field investigation of intangible cultural asset # 2, author Sir Shin Seok-bong of Daejeon Metropolitan Cityinvestigated the music of Antaek-gut, which is the base and core of Anjoon-gut, and found the following musical features: A Jang-gu(drum) and Kkoaengkwari(gong) were used to recitethe Sutra(kyungmoon) of Anjoon-gut. The Jang-gu, located on the right side, played an accompaniment role with regular beats when the Sutra was recited. The Kkoaengkwari, located on the left side, played the role of covering the caesura of the Sutra passages, so it is played with various rhythmic variations in accordance with Kojang(鼓杖). This is one way of playing Korean national classical music that has temporary caesuras, depending on the rector's bre! ath or the contents of a Sutra during the Sutra chanting, with the Jang-gu covering the pause with its variation. In other words, when being played in concert, the instruments that play the main melody are at rest while another instrument takes its turn to play the main melody as a form of prolonged sound. The rhythmic cycles of the sutras of Antaek-gut recited with this instrumental accompaniment consist of five types; a) Woemarch-jangdan (a single beat) of 4 meter by 3 bit, b) Dumarch-jangdan (two beats) of 8 meter by 3 bit, c) Saemarch-jangdan (three beats) of 4 meter by 3 bit with a fast tempo, d) Mak-gojang, uniform beats with a standardized rhythm, and e) incomplete beats deviated from the regular beats. Sir Shin Seok-bong chanted Chang (唱), a traditional native song which he called 'Cheong (淸)' with a cycle of 'Dumarch-jangdan' throughout the places of Antaek-gut. Only 'Toesonggyung' a chant for the gate that was the last location of the Antaek, was chanted with a cycle of 'Woemarch-jan! gdan'. In addition, 'Saemarch-jangdan' and 'Mak-gojang' that had comparatively faster tempos than the former two jangdans, were played without a chant when a female shaman was dancing and catching her spirit-invoking wand. The 'Saemarch-jangdan', particularly, was played while dancing began at a relatively slow tempo, then proceeded at a violent tempo and then back again to the slow tempo. This shows one of the representative tempos of our music with a slow-fast-slow tempo. The organizational tones were 'mi-la-do'-re'', and its key tones of 'mi-la-do'' were performed with perfect fourth and minor third, which was the same as those of Menari-tori. However, it did not show a typical Sigimse, an ornamental tone, of Menari-tory, whose first tone, 'mi', is vibrated and its Sigimse is gliding down from the tone 're' to 'do'. That is because the regional tone-tori of Chungcheong-do have a relatively weaker musical expression than that of Gyeongsang-do. In addition, the rhythmic types in accordance with the words of a song for the Antaek-gut music had a comparatively faster tempo than the other sutras. Also, it was only with 'Toesonggyeong' that the tone 'la' continuously appeared throughout the melody and showed 'a syllabic rhythm', while other places consisted of either a 'syncopation' or 'melismatic' rhythm. Finally, according to a brief investigation of the tone organization in accordance with each sutra, the tone 'la' was given more weight. The tone procedure showed a mainly ascending 'la-do'' and the descending 'la-mi' with minor third and perfect fourth. Also, the overall tempo proceeded with M.M.♩.=116-184, while the tempo for the Gut proceeded with M.M.♩.=120-140, which was suitable for reciting a Sutra.