• Title/Summary/Keyword: 전임상연구

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Blood Biomarkers for Alzheimer's Dementia Diagnosis (알츠하이머성 치매에서 혈액 진단을 위한 바이오마커)

  • Chang-Eun, Park
    • Korean Journal of Clinical Laboratory Science
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    • v.54 no.4
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    • pp.249-255
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    • 2022
  • Alzheimer's disease (AD) represents a major public health concern and has been identified as a research priority. Clinical research evidence supports that the core cerebrospinal fluid (CSF) biomarkers for AD, including amyloid-β (Aβ42), total tau (T-tau), and phosphorylated tau (P-tau), reflect key elements of AD pathophysiology. Nevertheless, advances in the clinical identification of new indicators will be critical not only for the discovery of sensitive, specific, and reliable biomarkers of preclinical AD pathology, but also for the development of tests that facilitate the early detection and differential diagnosis of dementia and disease progression monitoring. The early detection of AD in its presymptomatic stages would represent a great opportunity for earlier therapeutic intervention. The chance of successful treatment would be increased since interventions would be performed before extensive synaptic damage and neuronal loss would have occurred. In this study, the importance of developing an early diagnostic method using cognitive decline biomarkers that can discriminate between normal, mild cognitive impairment (MCI), and AD preclinical stages has been emphasized.

항균제 임상시험 Guideline

  • 우준희
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 1994.11a
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    • pp.27-30
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    • 1994
  • 잠재적으로 항감염 약제로 사용될 가능성이 있는 약제들의 초기 연구과정에서 주된 관심사는 이들이 미생물(세균, 바이러스, 기타 기생충)에 대한 작용들이 있는가 하는 점이다. 이러한 작용들이 실험적으로 충분히 연구가 된 후에야 실험동물에서 그 효과를 연구한다. 항 바이러스 제제의 경우에는 세포배양을 통한 연구가 그 약제의 독성과 효용성을 나타내는데 필수적인 것이 된다. 여러 종류의 동물을 이용한 생체실험에서 약제의 일반적인 흡수와 배설, 분포 등에 관한 정보와 약제 자체와 동물 내에서의 대사적 변화에 대한 정보가 제공된다. 여러 가지 미생물로 감염을 시킨 적합한 동물과 여러 가지 용량으로 치료하는 실험을 통하여 약제의 항 감염 능력이 알려지게 된다. 동물에서의 생체실험과 실험관내에서 실험을 하고 나서야 사람에서의 연구가 이루어지게 된다. 소위 전임상시험에서 대표적 병원성 미생물에 대한 생물학적효과, 약리학적 효과와 독성 그리고 동물실험모델에서의 가능한 효과가 결정된 후에 임상시험에 들어가기 마련이다. 항균제의 임상시험에는 각각의 감염질환에 대한 진단 및 치료기준을 반영하는 것이 기본이다. 새로운 항균제의 임상시험에서는 안전성과 효과가 반드시 밝혀져야 한다. 1상에서는 인체에서의 약리효과, 안전성이 주목적이며, 2상과 3상은 겹쳐지는 점도 있으나 하나 또는 그 이상의 적응증에 대한 항균제의 효과와 단기간의 부작용은 2상에서 관찰하여야하며, 다수의 환자에서 제안된 적응질환의 무작위임상시험과 다수에서의 안전성도 3상에서 관찰하여야 한다. 4상에서는 이상에서의 자료로 시판된 후에도 계속해서 감시하는 것으로 지속적으로 안전성을 관찰하는 것이다. 이러한 기본사항외에도 소아, 임산부, 고령자등에서의 임상시험도 넓은 의미에서 포함되어야 할 것이며 또한 질적인 면에서 조절하는 Quality Assurance도 중요하다.양상은 세 용량군 간 차이가 없었으나, 시험기에서 발열의 발현율이 낮았으며, 발열일 수와 항생제 사용일 수가 짧았다. 결론: 골수억제 조절 효과는 용량에 따른 혈액소견에 미치는 영향, 부작용, 감염의 빈도, 감염발생에 따른 항생제 사용기간 등을 고려하여 그 임상 유효성 평가시, 제 3상 시험에 사용할 권장량 (recommended dose) 은 250 ug/$m^2$/d $\times$ 10d 으로 관찰되었다.5주에 부검한 랫드의 간에서 c-myc 종양단백의 발현은 모든 처리군들이 대조군에 비하여 높게 발현되는. 것이 관찰되었으나 시험개시후 26주에 부검한 랫드의 간에서 c-myc 종양단백의 발현은 대조군에 비하여 차이가 거의 없었다. 따라서 랫드에서 화학적으로 유도한 간암발생 과정에서 NK 세포활성이 현저하게 억제되는 것으로 생각되며, c-myc 종양단백의 발현은 시험개시후 15주에 그 발현이 확실한 것으로 사료되어 진다.에 영향을 주는 성분이 있음을 제시하였다.1과 항우울약들의 항혈소판작용은 PKC-기질인 41-43 kD와 20 kD의 인산화를 억제함에 기인되는 것으로 사료된다.다. 것으로 사료된다.다.바와 같이 MCl에서 작은 Dv 값을 갖는데, 이것은 CdCl$_{4}$$^{2-}$ 착이온을 형성하거나 ZnCl$_{4}$$^{2-}$ , ZnCl$_{3}$$^{-}$같은 이온과 MgCl$^{+}$, MgCl$_{2}$같은 이온종을 형성하기 때문인것 같다. 한편 어떠한 용리액에서던지 NH$_{4}$$^{+}$의 경우 Dv값이 제일 작았다. 바. 본 연구의 목적중의 하나인 인체유

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A Study on Development of Wrinkle Evaluation Software and Verification of Skin Wrinkle Improvement of Cog Suture (주름 평가 소프트웨어 개발과 Cog형 봉합사의 피부 주름 개선 검증에 관한 연구)

  • Jeong, Jin-Hyoung;Lee, Sang-Sik
    • The Journal of Korea Institute of Information, Electronics, and Communication Technology
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    • v.12 no.4
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    • pp.336-342
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    • 2019
  • With the entry of an aging society, the average life span of accreditation has been extended. Therefore, interest in the appearance of men and women in modern society has increased. It is the wrinkles of the face that can judge the most outwardly. People tend to have various kinds of treatments to have a clean, wrinkle-free and resilient healthy skin regardless of sex. There is a lot of practice of lifting procedures in one of the procedures. A suture using a melting thread is a method of lifting by squeezing it into the skin as a non-incision type centering on a region where the thread can be fixed in the skin by injecting it into the subcutaneous fat layer. To evaluate the lifting efficacy of Cog - type suture for the improvement of skin wrinkles, preclinical experiments were conducted. We developed a wrinkle evaluation program using Labview. Data from preclinical experiments were used at 8 weeks after suturing. The average wrinkle depth was 415.6 mm in the control group. At 8 weeks, the depth of wrinkles was deepened to 888.3mm due to the aging process of the control group. On the other hand, the depth of the wrinkles before surgery was 640.3 mm in the suture group. It was confirmed that the depth of wrinkles decreased to 566.5mm at 8th week after the suture operation.

Recent Interventional Procedures for Spinal Discogenic Pain for Life Care : Technical and Ethical Issues (라이프케어를 위한 추간판성 통증 치료의 최신중재기법 기술적 윤리적 문제들에 관하여)

  • Hong, Young-Ki
    • Journal of Korea Entertainment Industry Association
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    • v.13 no.4
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    • pp.311-320
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    • 2019
  • Discogenic pain which develops during the degenerative process of intervertebral disc is an intractable disease of musculoskeletal system. Unlike other diseases in modern medical science, it is not clinically confirmed through objective imaging and clinicopathologic index. Moreover, current technology has been facing difficulties finding fundamental treatment. This study examined through reviewing literature whether the therapeutic rationales of interventional procedures for the discogenic pain, such as nerve block, intradiscal electrothermal therapy and nucleoplasty, are valid and whether safety reviews such as preclinical tests are carried out faithfully during the technology development process. As a result, it is presumed that there is not yet an interventional treatment for discogenic pain, whose therapeutic rationale has been objectively verified. And there are some cases of interventional treatment that have not been adequately equipped with the preclinical test steps necessary to review the safety of the procedure during the technology development process. In conclusion, since there is still no interventional treatment for discogenic pain which has clear therapeutic rationale, it is necessary to recognize that a more careful approach is needed to judge whether the procedure is performed in clinical settings. And medical ethical issues may arise for some interventional treatment that are deemed to have been carried out without a thorough review of safety.

Non-Robotic, Endoscopic Hemi-Thyroidectomy via Retro-auricular Single-incision Approach : A Preclinical Feasibility Study in Cadavers (후이개 절개를 이용한 내시경 갑상선 절개술-전임상 사체연구)

  • Lee, So-Yoon;Sun, Dong Il;Ahn, Su Hyun;Lee, Il Hwan;Park, Young Hak
    • Korean Journal of Head & Neck Oncology
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    • v.30 no.1
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    • pp.10-14
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    • 2014
  • 목 적 CO2 가스 삽입 없이 내시경 보조 갑상선 절제술, 특히 액와 절개를 이용하는 경우의 대부분은 기구 사용을 용이하게 하기 위하여 흉부 또는 유륜에 절개를 넣어 시행하는 것이 대부분이다. 본 연구는 후이개 절개를 통하여 추가적 절개 없이 내시경을 이용한 갑상선 절제술 및 중심 임파선 절제술이 가능한지의 여부를 사체연구를 통하여 확인해 보고자 한다. 방 법 사체 이용 해부 및 수술 후이개 내시경 보조 갑상선 절제술이 가능한지의 확인은 수술 시야 및 접근성, 수술 완성도, 그리고 주요 구조물의 보존 여부인 3가지 항목으로 평가하였다. 결 과 수술 시야는 기구를 다루고 수술을 하기에 충분하였으며, 추가 절개 없이 수술을 완성할 수 있었다. 절제된 갑상선 조직의 피막은 손상되지 않았으며, 잔존 갑상선 조직이 없음을 수술 부위를 통하여 확인하여, 수술의 완성도 여부를 평가할 수 있었다. 모든 사체에서 되돌이 후두신경 및 상 또는 하부갑상선의 보존을 확인하였으며, 주변 구조물들의 손상이 없음을 확인하였다. 결 론 로봇이 아닌 후이개 절개를 이용한 내시경 보조 갑상선 절제술은 시행 가능한 접근법 및 수술방법이라 사료된다.

The Influence of the Sympathetic Nervous System on the Development and Progression of Cancer (교감신경계가 암의 발전과 진행에 미치는 영향)

  • Park, Shin-Hyung;Chi, Gyoo-Yong;Choi, Yung Hyun
    • Journal of Life Science
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    • v.28 no.1
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    • pp.116-129
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    • 2018
  • Living creatures possess long-conserved mechanisms to maintain homeostasis in response to various stresses. However, chronic and continuous exposure to stress can result in the excessive production of stress hormones, including catecholamines, which have harmful effects on health. Studies on the relationship between the sympathetic nervous system (SNS) and cancer have been conducted based on the traditional hypothesis that stress can promote cancer progression. Many preclinical and epidemiological studies have suggested that the regulation of ${\beta}$-adrenergic signaling, which mediates SNS activity, can suppress the progression of solid tumors. SNS activation has highly pleiotropic effects on tumor biology, as it stimulates oncogenes, survival pathways, the epithelial - mesenchymal transition, and invasion. Moreover, it inhibits DNA repair and programmed cell death and regulates the tumor microenvironment, including immune cells, endothelial cells, the extracellular matrix, mesenchymal cells, and adipocytes. Although targeted therapies on the molecular basis of tumor proliferation are currently receiving increased attention, they have clinical limitations, such as the compensatory activation of other signaling pathways, emergence of drug resistance, and various side effects, which raise the need for pleiotropic cancer regulation. This review summarizes the effects of the SNS on the development and progression of cancer and discusses the clinical perspectives of ${\beta}$-blockade as a novel therapeutic strategy for this disease.

Analysis of Studies on Pyeongwi-san to Establish the Fundament for Evidence Based Medicine (EBM 기반구축을 위한 평위산 전임상 연구 문헌 분석)

  • Kim, Jung-Hoon;Lee, Jun-Kyoung;Shin, Hyeun-Kyoo
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.24 no.5
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    • pp.770-778
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    • 2010
  • To establish the fundament for EBM of Traditional Korean Medicine, the papers on Pyeongwi-san (Pingwei-san) frequently used in medical institutions of Traditional Korean Medicine were analyzed through researching domestic and international papers. The papers were classified by the registration of domestic or international journals, the year of publishment, experimental fields and the kinds of studies on biological activities. Of total 518 papers on Pyeongwi-san (Pingwei-san), 32 volumes were selected according to selection creteria. 20 volumes were published in domestic journals, 11 in Chinese journal and 1 in Japanese journal. The papers on instrumental analyses reported the quantification of standard compounds of herbal medicines in Pyeongwi-san (Pingwei-san) using HPLC, GC-MS. The papers on biological activities of Pyeongwi-san (Pingwei-san) showed improvement of gastrointestinal activity and water-electrolyte metabolism, immune regulation, anti-oxidant, anti-inflammatory, analgesic, anti-convulsant activities, hypnotic duration, blood pressure regulation, hepatic protection, congestive heart failure, anti-cancer activities. Further studies including gastrointestinal activity need to be preceeded to establish the fundament for EBM of Pyeongwi-san (Pingwei-san).

Studies of antitumor activities for ara-CDP-DL-PTBA as a lead compound of anti-cancer agent.

  • Jee, Yong-Hun;Lee, Chul-Kyu;Kang, Sung-Gu;Park, Woo-Yle;Lee, Hyung-Hoan;Hong, Chung-Il;Suh, Jung-Jin
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 1995.04a
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    • pp.85-85
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    • 1995
  • 전년도에 ara-C 유도체 중에서 ara-CDP-DL-PTBA가 각종 암세포주에 대한 뛰어난 항암작용이 보고된바 있으며, 이후 시료의 대량확보, Bulk Formulation 및 전임상등의 세가지 분야에 관해 연구를 수행하였다. Ara-CDP-DL-PTBA를 수용액에 현탁, 초음파분쇄후 NICOMP Analysis에 의하여 micellar solution의 입자도를 알아 본 결과 fresh prepared micelles은 11,1mm size가 88.63%이며 50,5mm가 11.37%로 나타나 평균 19,0mm가 되고, Reconstructed micells은 10.9mm size가 99.87%이며 356.1mm가 0.13%로 나타나 평균 11.0mm가 된다. Ara-C와 Ara-CDP-DL-PTBA의 대사작용을 알아본 결과, ara-C는 투여 1시간째 2,850 $\pm$ 450 pmol, 4시간째 450$\pm$190 pmol, 24시간째 30 pmol 이하로 ara-CTP의 혈중 농도가 급격히 감소하는 반면에 ara-CDP-DL-PTBA는 1시간째 650$\pm$120 pmol, 2시간째 1,800$\pm$500 pmol, 24시간째 300$\pm$90 pmol으로 ara-CTP의 혈중 농도가 서서히 감소하였다.

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The Pre-Clinical Experiments of the Compounding Antipyretic Analgesics (배합해열진통제(配合解熱鎭痛劑)의 전임상시험(前臨床試驗)에 관(關)한 연구(硏究))

  • Kim, Jae-Wan
    • Journal of Pharmaceutical Investigation
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    • v.10 no.1
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    • pp.4-12
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    • 1980
  • The studies of the compounding analgestic antipyretics were examined by the converted Koster's method (mice) and the converted Mac Donald's method (mice) induced on the three assumption crossover test. And the following results were found. 1. The same effect of the writhing inhibition in this compounding antipyretic dosage by it's oral administration is as follows. Aminopyrine 100mg/kg. (standard), aminopyrine 50mg/kg compounding with chlorpheniramine maleate 2mg/kg., compounding with diphenhydramine hydrochloride 8mg/kg., compounding with atropine sulfate 0.2mg/kg., or compounding with scopolamine hydrobromide 0.2mg/kg. And aspirin80mg/kg., Salicylamide 90mg/kg., sulpyrine 60mg/kg., or phenacetin 70mg/kg. compounding with the same dosage of the adjutants above. 2. The elevation-rate of the reaction threshold in this compounding antipyretic dosage by it's oral administration calculate as follows. When the elevation-rate (ER) of aminopyrine (100mg./kg.) is 1.00 (Standard), ER of aminopyrine (50mg./kg.) compounding with chlorpheniramine maleate (2mg./kg.) calculated 1.42, aspirin (80.mg./kg.) compounding with diphenhydramine hydrochloride (80mg./kg.) calculated 1.18, salicylamide (90mg./kg.) compounding with chlorpheniramine maleate (2mg./kg.) calculated 1.15, sulpyrine (60mg./kg.) compounding with chlorpheniramine maleate(2mg./kg.) calculated 1.28, and ER phenacetin (70mg./kg.) compounding with chlorpheniramine maleate (2mg./kg.) calculated 1.19.

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Selection for preclinical study candidate through analysis of frequently used medications presented in Donguibogam Stroke chapter (『동의보감(東醫寶鑑)』 풍문(風門) 처방 및 구성 약재의 인용 빈도 분석을 통한 전임상 연구 후보 약재 선별)

  • Lim, Chiyeon;Lim, Sehyun;Lee, Byoungho;Cho, Suin
    • Herbal Formula Science
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    • v.30 no.3
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    • pp.165-174
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    • 2022
  • Objectives: Donguibogam has helped progress of Eastern medicine across Asia and almost all of Korean medicine doctors still use the book as a classic reference. In this study, the prescriptions used in the treatment of stroke in Donguibogam are analyzed and the results are to be used for our subsequent studies. Methods: The frequency of use of prescriptions and the frequency of combination of medicines were analyzed from 89 prescriptions used in the Stroke chapter of Donguibogam, and it was intended to derive a combination prescription and a monosyllabic medicine that can be effectively used in the treatment of stroke for preclinical studies. Results: Ganghwalyupung-tang (羌活愈風湯) was the most mentioned prescription among 89 prescriptions, and Glycyrrhizae Radix et Rhizoma, among 165 species of medicines used in the 89 prescriptions, mixed in 55 prescriptions. However, considering the ratio of frequently used medicines, Sagunja-tang (四君子湯) was the highest in terms of composition ratio. Conclusions: Through this study, Glycyrrhizae Radix et Rhizoma and Sagunja-tang were selected as materials for our subsequent studies.