• Title/Summary/Keyword: 약물 안전성

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Effects of Cordyceps militaris supplementation on the immune response and upper respiratory infection in healthy adults: a randomized, double-blind, placebo-controlled study (건강한 성인을 대상으로 면역증강 및 상기도 감염 예방에 대한 동충하초주정추출물의 유효성 평가 : 이중맹검 플라세보 대조 연구)

  • Jung, Su Jin;Hwang, Ji Hyun;Oh, Mi Ra;Chae, Soo Wan
    • Journal of Nutrition and Health
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    • v.52 no.3
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    • pp.258-267
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    • 2019
  • Purpose: Upper respiratory tract infections are major causes of the common cold throughout the world. Cordyceps militaris (C. militaris) is a well-known functional food for its anti-fatigue and immunomodulating activities. On the other hand, there are no reports on the protective effect against upper respiratory tract infections (URI). This study was a 12 week randomized, double-blind, and placebo-controlled trial in healthy volunteers. Methods: A total of 100 subjects 20 ~ 70 years of age with a history of at least two colds in the year were enrolled in the study. The participants were required to record any adverse events and rate any cold-related incidents in a diary during the investigation period. The efficacy end point was the symptoms and incidence of URI, and changes in cytokines, IgA and natural killer (NK) cell activity. Results: The Cordyceps militaris group over 12 weeks showed no significant impact on the incidence and symptomatology of URI compared to the placebo group. On the other hand, the experimental group showed significantly higher NK cell activity (p = 0.047) and IgA level (p = 0.035) compared to the placebo group. The NK-cell activity and IgA level were increased significantly by Cordyceps militaris over 12 weeks. Conclusion: The results suggest the possible beneficial immunomodulating effects, but the protective effects on URI could not be demonstrated under these conditions. Additional research will be needed to determine the efficacy and mechanisms of Cordyceps militaris function.

Safety and Feasibility of Thallium-201 Myocardial SPECT with Intravenous Infusion of Disodium Adenosine Triphosphate (ATP) in the Diagnosis of Coronary Artery disease (관상동맥 질환 진단에서 ATP부하 T1-201 심근 관류 SPECT의 안전성과 유용성)

  • Pai, Moon-Sun;Park, Chan-H.;Yoon, Seok-Nam;Kim, Won;Kim, Han-Soo
    • The Korean Journal of Nuclear Medicine
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    • v.32 no.3
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    • pp.250-258
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    • 1998
  • Purpose: ATP (adenosine triphosphate) is a potent coronary vasodilator with a rapid onset of action and a very short half-life. Myocardial perfusion scintigraphy with intravenous ATP has not yet been sufficiently proven in the diagnosis, follow-up, and risk stratification of coronary artery disease. The purpose of this study was to evaluate the safety, feasibility and diagnostic accuracy of pharmacologic stress thallium-201 myocardial SPECT using an intra-venous ATP infusion in patients with suspected coronary artery disease. Materials and Methods: Thallium-201 myocardial SPECT in 319 patients with suspected coronary artery disease were performed after the infusion of ATP (0.08 mg/kg/min for 6 min). The adverse effects were carefully monitored. Coronary angiography was also performed within 3 weeks. Results: Although 76.5% of the patients had some adverse effects, they were transient, mild, and well tolerated. In all patients, the ATP infusion protocol was completed and only 2 patients required aminophylline. The adverse effects were dyspnea in 63%, headache in 31%, flushing in 21%, chest pain in 14% and abdominal discomfort in 5% of the patients. The sensitivity and specificity were 80% and 90% respectively. Conclusion: Thallium-201 myocardial SPECT after 6 min-infusion of ATP at a rate of 0.08 mg/kg/min is safe and has a diagnostic value in detecting coronary artery disease.

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Analysis of Safety Education Contents of 『Field of home life』 in Technology·Home Economics Textbook developed by the revised curriculum in 2009 (2009 개정 기술·가정 교과서 『가정생활영역』의 안전교육 내용 분석)

  • Kim, Nam Eun
    • Journal of Korean Home Economics Education Association
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    • v.29 no.2
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    • pp.23-39
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    • 2017
  • The Purpose of this study is to present the basic data for selecting and improving the safety education contents which help practically middle school students through analysis of contents of safety education in 'field of home life' of 2009 revised middle school textbooks. The subjects of analysis are 12 types of middle school textbooks: in total 24 books written by 12 publishers in terms of the revised curriculum in 2009. The analysis criteria is developed by the researcher referring to preceding studies regarding safety education based on the seventh safety education standard presented by the Ministry of Education (2015). With such analysis criteria, all words related to the contents of the safety education of analysis criteria were extracted from each textbook, such as words directly mentioned as 'safety', words mean as 'psychological safety' and 'happy life', words related to 'attention', 'note', 'stability' etc. Under the analytic frame of safety education contents according to a home economics textbook, content analysis method was used for producing the frequency and percent of those words. The textbook analysis shows that the number of pages regarding safety education is 336.3 pages, as 9.8% in total 3,412 pages of 12 types of technology and home economics textbooks. As following the analysis of each textbook volume of the proportion in the contents related to safety education, 224.9 pages are on the first volume and 111.9 pages are on the second volume. As grades increase from year one to year three, the proportion of safety education in home economics textbooks is decreased. The highest number of safety education contents unit is 'Self-management of youth' which includes three parts of safety education. In the case of a unit for emphasizing practice, experience and practical exercise such as 'Life of youth' and 'Practice of eco-living', safety education content in the area of 'life safety' are mostly contained. Safety accidents related to the most student experienced, Household accidents (1.4%) and experiment or practice accidents (0.3%) are presented in a low figure. The contents of universal housing and school violence are duplicated on first and second volume of text. The most presented safety education content in the 12 types of textbooks are proper sexual attitude, dietary problems, family conflict and food choice. The least common contents are dangerous drugs, family welfare, internet addiction and industrial accident compensation insurance. As this study is to analyze 12 textbooks developed in 2009 revision curriculum, it is necessary to compare it with the textbook written by the revised curriculum in 2015 and to clarify the contents system of safety education and to avoid duplication of contents. In addition, it is necessary to develop and distribute a safety education program that can support textbooks.

NEW ANTIDEPRESSANTS IN CHILD AND ADOLESCENT PSYCHIATRY (소아청소년정신과영역의 새로운 항우울제)

  • Lee, Soo-Jung
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.14 no.1
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    • pp.12-25
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    • 2003
  • Objectives:As increasing number of new antidepressants have been being introduced in clinical practice, pharmacological understanding has been broadened. These changes mandate new information and theories to be incorporated into the treatment process of children with depressive disorders. In light of newly coming knowledge, this review intended to recapitulate the characteristics of new antidepressants and to consider the pivotal issues to develope guidelines for the treatment of depression in childhood and adolescence. Methods:Searching the Pub-Med online database for the articles with the key words of 'new', 'antidepressants' and 'children' ninety-seven headings of review articles were obtained. The author selected the articles of pertinent subjects in terms of either treatment guideline or psychopharmacology of new antidepressants. When required, articles about the clinical effectiveness of individual antidepressants were separatedly searched. In addition, the safety information of new antidepressants was acquired by browsing the official sites of the United States Food and Drugs Administration and Department of Health and Human Services. Results:1) For the clinical course, treatment phase, and treatment outcome, the reviews or treatment guidelines adopted the information from adult treatment guidelines. 2) Systematic and critical reviews unambiguously concluded that selective serotonin reuptake inhibitors(SSRIs) excelled tricyclic antidepressants( TCAs) for both efficacy and side effect profiles, and were recommend for the first-line choice for the treatment of children with depressive disorders. 3) New antidepressants generally lacked treatment experiences and randomized controlled clinical trials. 4) SSRIs and other new antidepressants, when used together, might result in pharmacokinetic and/or pharmacodynamic drug-to-drug interaction. 5) The difference of the clinical effectiveness of antidepressants between children and adults should be addressed from developmental aspects, which required further evidence. Conclusion:Treatment guidelines for the pharmacological treatment of childhood and adolescence depression could be constructed on the basis of clinical trial findings and practical experiences. Treatment guidelines are to best serve as the frame of reference for a clinician to make reasonable decisions for a particular therapeutic situation. In order to fulfill this role, guidelines should be updated as soon as new research data become available.

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Evaluation of the Bioequivalence of Two Brands of Naltrexone 50 mg Tablet in Healthy Volunteers

  • Baek, In-Hwan;Yun, Hwi-Yeol;Kang, Won-Ku;Kwon, Kwang-Il
    • Korean Journal of Clinical Pharmacy
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    • v.16 no.1
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    • pp.69-74
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    • 2006
  • 날트렉손은 ${\mu}-opioid$ 수용체에 특이적이고 선택적으로 길항작용을 나타내어 마약이나 마약성 진통제의 강한 의존성 치료에 쓰일 뿐만 아니라, 알코올 의존성 치료에도 쓰이는 약물이다. 본 연구는 날트렉손 제제인 레비아 정 (50 mg tablet, 제일약품) 을 대조약으로 하여 시험약인 명인 제약의 트락손 50 mg정의 생물학적 동등성 평가를 하기 위해 22명의 건강한 지원자를 모집하였다. 지원자를 두 군으로 나누어 1정씩 투여하였고 $2{\times}2$ 교차시험을 실시하였다. 날트렉손의 혈장 중의 농도를 정량하기 위하여 발리데이션된 LC/MS/MS를 사용하였다. 채혈 시간은 투약 전 및 투약 후 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12 시간에 걸쳐 시행하였다. 생물학적 동등성을 판정하기 위한 파라미터로 12시간까지의 혈장 중 농도 곡선 하 면적$(AUC_{12hr})$과 최고 혈중 농도 $(C_{max})$를 사용하였다. $AUC_{12hr}$의 평균은 $43.45ng{\cdot}hr/ml$ (시험약)과 $43.31ng{\cdot}hr/ml$ (대조약) 으로 관찰되었고, $C_{max}$의 경우 각각 12.01 ng/m1 (시험약)과 12.27 ng/ml (대조약)으로 관찰되었다. $AUC_{12hr}$의 경우 로그변환 한 평균치 차의 90%의 신뢰구간이 log0.95-log1.07이었고, $C_{max}$의 경우 log0.87-log1.14로 계산되어 두 항목 모두 log0.8-log1.25이어야 한다는 식품의약품 안전청과 FDA의 기준을 모두 만족시켰다. 이상의 결과를 종합하면 시험약 트락손 정 50mg 은 대조약 레비아 정 50 mg에 대하여 생물학적으로 동등한 것으로 판정되었다.

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The nutritional functions and physiological activities of rose hip (Rosa canina fruits): A systematic review (로즈힙의 영양학적 기능 및 생리활성에 대한 문헌적 고찰)

  • Jung, Tae-Hwan;Hwang, Hyo-Jeong;Shin, Kyung-Ok
    • Korean Journal of Food Science and Technology
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    • v.54 no.4
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    • pp.369-376
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    • 2022
  • This study was conducted to investigate the efficacy of rose hip utilization on various diseases. Rose hips are produced on a shrub native to Europe, and have been used for medicinal purposes and nutritional supplementation for centuries. It is rich in minerals, vitamins, and various functional compounds, including calcium, magnesium, phosphorus, potassium, selenium, vitamin B, vitamin C, and vitamin E, quercetin, catechin, β-carotene, β-sitosterol, polyphenol, flavonoid, taxifolin, ellagic acid, and salicylic acid. Extracts and powders of rose hips have been reported to contain antioxidant, free radical scavenging, and anti-inflammatory activity, and exert beneficial effects including amelioration of osteoarthritis, body fat reduction, anti-obesity activity, anti-bacterial activity, antidiabetic properties, and anti-cancer activity. Therefore, rose hips as a functional natural food may be considered effective for use in treating diseases including obesity, diabetes, osteoporosis, cardiovascular disease, and cancer.

Trophic Factors of Gastrointestinal Tract (위장관의 영양인자)

  • Kim, Yong Joo
    • Clinical and Experimental Pediatrics
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    • v.46 no.1
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    • pp.6-10
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    • 2003
  • 동물과 사람의 연구에서 위장관 영양 인자는 위장관 점막이 점막손상으로부터의 회복에 중요하고 출생 후 경구 영양에 적응할 수 있게 하는 데에 중요하다. 경구적으로든 전신적으로 투여된 성장 인자들은 위장관의 성장과 발달을 촉진시킨다. 신생아 혈중의 영양인자들이 장관 세포의 수용체를 통해 작용하여 위장관의 성장을 조율한다. 위장관 영양인자들은 체내에서 합성될 수도 있고 모유를 통해 공급된다. 사람에서 출생 후 위장관이 장관영양에 신속히 적응할 수 있도록 위장관 영양 인자들이 중요한 작용을 한다. 모유 내의 성장 인자들이 신생아 생존에 필수적인 것들은 않아도 모유를 먹은 영아들이 조제분유를 먹은 영아들에 비하여 급성 설사, 괴사성 장염, 크론씨 병과 같은 위장관 질환의 위험율이 낮다. 위장관 영양 인자들의 대부분이 시판 조제분유에는 존재하지 않고 주로 모유에 존재함을 앎으로써 모유의 장점을 설명하는 데에 적용할 수 있을 것이다. 그리고 위장관 영양인자는 위장관 점막 손상된 경우 치료 목적으로 사용될 수 있는 여지가 높다. 이러한 임상적 이용은 특히 미숙아, 수술 후의 영아 등에서 적용될 수 있다. 그러나 향후 더욱 연구되어야 할 항목들로는 작용기전, 경구 및 정맥 투여 방법에 의한 효과의 차이, 체내 성장 인자들과의 상호 작용, 외부적 투여가 체내 인자에 대한 영향, 위장관 이외의 타 기관에 대한 영향, 그리고 안전성과 약물 역동학적인 특성 등이다.

Measures against Security Safety and Hallucinogenic Drug Crimes (환각성 약물범죄와 경호안전상의 대응방안)

  • Jeon, Kyung-Soo
    • Korean Security Journal
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    • no.2
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    • pp.211-226
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    • 1999
  • Troublesome problems are being caused by hallucinogenic drugs which come not only from illegal narcotics but also from unprohibited general drug-kinds such as cough-remedy agents of textromerupan, namely, Lamina, Rubi-king and the likes. Abuse and misuse of narcotics permeated into and threatens mental health of socially-known peoples, actor, actress, talents and businessmen as well. This study especially dealt with problems related with Mesampetamin, Rurajaepam, Texstrometropan and Karisofrodol which affects mental behaviour, and considered counter-measures through analysis and developed appropriate system of goods circulation for guidance to be complied by the medicine professionalists. The guidance sought here is recommended to the government ministries for further enforcement of crack-down of the drug crimes. Arquesa in method is recommend as a method of identifying behaviors and facial expressions of abusers and misusers of narcotics at the spot in place. This study is directed to curtailing hallucinogenic drugs use for absolute preventive security by detecting out black dealers of narcotics supplying to the abusers and misusers. There is a need of special education program to cut off the flow of narcotics or drugs crimes into official security force as well as private security personnel. This study introduced a priority and emphasis of real augmentation to theory and practice of the modern scientific security which can protect the mental health of the guarded persons as well especially in the light of security safety curriculum at the school.

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Current State and Applications of the Electronic Clinical Trial Process in Korea (국내 임상시험 전자화 현황과 적용방안)

  • Wang, Boram;Choi, Inyoung
    • The Journal of the Korea Contents Association
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    • v.13 no.4
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    • pp.281-289
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    • 2013
  • As the number of clinical trials conducted in Korea increases, the need of the Electronic Data Capture (EDC) system for effective clinical data management is also increased. Recently, the Korea Food and Drug Association published 'Guideline for the Electronic Clinical Trial Data Management and Processing' and it would be the foundation for establishing regulation of electronic clinical data management. In this research, we conducted the survey regarding adoption rate of EDC system in clinical trials in hospitals, Contract Research Organizations (CRO), and pharmaceutical companies. And the perceived importance and the ease of application for the Guideline were investigated. The adoption rates of EDC system was 77.6% but it mostly applied to less than five trials. Also EDC system was mostly used in phase I and phase II trials and the utilization rate of CRO was the highest. The perceived importance for the Guideline was high among all three organizations but, in case of the perceived ease of its application, CRO was the highest. Also, the perceived importance of the clinical data standard was high and the standard for data collection was mostly required. However, the comprehension for the global standard of the electronic data was relatively low, so that education is required. This result would be the foundation to increase the electronic clinical trials and develop proper regulation and principles for clinical data standards in Korea.

Fabrication and characterization of 3-D porous scaffold by polycaprolactone (폴리카프로락톤을 이용한 3차원 다공성 지지체 제조 및 특성 분석)

  • Kim, Jin-Tae;Bang, Jung Wan;Hyun, Chang-Yong;Choi, Hyo Jeong;Kim, Tae-Hyung
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.2
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    • pp.58-65
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    • 2016
  • This study was a preparatory experiment aimed the development of membrane scaffolds for tissue engineering. A PCL composite solution contained sodium chloride(NaCl). PCL porous membrane scaffolds were formed on a glass casting plate using a film applicator and immersed in distilled water to remove the NaCl reaching after drying. NaCl was used as a pore former for a 3 dimensional pore net-work. The dry condition parameters were $4^{\circ}C$, room temperature (RT) and $40^{\circ}C$ for each different temperatures in the drying experiment. SEM revealed the morphology of the pores in the membrane after drying and evaluated the in vitro cytotoxicity for basic bio-compatibility. The macro and micro pores existed together in the scaffold and showed a 3-dimensional pore net-working morphology at RT. The in vitro cytotoxicity test result was "grade 2" in accordance with the criterion for cytotoxicity by ISO 10993-5. The dry condition affected the formation of a 3 dimensional pore network and micro and macro pores. Therefore, these results are expected provide the basic process for the development of porous membrane scaffolds to control degradation and allow drug delivery.