• 제목/요약/키워드: clinical guideline

검색결과 842건 처리시간 0.031초

마황윤폐탕(麻黃潤肺湯) 추출물의 수컷 SD Rats에서 경구 단회투여 독성 평가 (Single Dose Toxicity Test of Mahwangyounpae-tang Extract in Male SD Rats)

  • 조동희;박미연;최해윤;김종대;전귀옥
    • 대한한방내과학회지
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    • 제27권1호
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    • pp.102-113
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    • 2006
  • Objectives & Methods : To obtain the 50% lethal dose(LD50), approximated lethal dose(ALD) and approximated target organs of 'Mahwangyounpae-tang' for further study into such things as repeated dose toxicity, genotoxicity and reproductive toxicity, single dose toxicity was tested in male SD rats according to KFDA Guideline 1999-61[KFDA, 1999] at dosage levels of 2,000, 1,000, 500, 250 and 125 mg/kg/$10m{\ell}$. In this study, mortalities, clinical signs, body weight changes and body weight gains, gross findings and weight of principal organs were detected during and/or after 14 days of single dosing. Results & Conclusions : After 2 or 3 days of dosing, 1 or 2 animals in 2,000 mg/kg-dosing groups died. Excitation and leaping response were observed as test article-treatment related clinical signs. These abnormal signs were restricted to 2,000 and 1,000 mg/kg-dosing groups and survivors recovered to normal within 3 or 4 days after dosing. Significant decrease in body weight were observed in some periods of observation in 2,000 and 1,000 mg/kg-dosing group, from 1 days after dosing compared to those of vehicle control group. Significantly diminished body weight gains were observed in observation periods in 2,000 and 1,000 mg/kg-dosing group compared to those of vehicle control group. Hypertrophy and hemorrhage of heart and decoloration of kidney were observed as test article-treatment related gross findings. These abnormal findings were restricted to 2,000 and 1,000 mg/kg-dosing groups. A significant increase of absolute and relative heart and kidney weight were demonstrated in 2,000 mg/kg-dosing groups. The value for LD50 found in this study was 2,218.57 mg/kg. ALD in this study was 2,000 mg/kg, and the target organs are considered to be the heart and the kidney.

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심방세동 환자의 고주파 도자절제술 전.후의 항응고약물요법 사용실태 분석 (Evaluation of Peri-procedural Anticoagulation Drug Therapy undergoing Radiofrequency Ablation in Patients with Atrial Fibrillation)

  • 김수현;안성심;김순주;방준석;나현오
    • 한국임상약학회지
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    • 제20권2호
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    • pp.159-164
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    • 2010
  • Radiofrequency ablation (RA) is being used to manage atrial fibrillation (AF) with patients failed at the $1^{st}$-line anti-arrhythmic medications. Patients undergoing this procedure are at increased risk of thromboembolism after ablation, and anticoagulation management surrounding the ablation remains controversial. Although no conclusive recommendations can be made, published guidelines and data support therapeutic anticoagulation with warfarin. The purpose of this study was to analyze effectiveness of current therapy and to find factors fluctuate International Normalized Ratio (INR) values in patients undergone RA followed by anticoagulation service (ACS). Retrospective review was conducted utilizing database in a hospital. Among 110 patients under warfarin around ablation between January 2006 to September 2007, 54 patients were selected and allocated into 2 groups: Group A included 47 who discontinued warfarin after ablation, while 7 in B continued the medication. Information on demographics, amount and length of warfarin dosing, INR values and measuring frequencies, and the causing factors on INR fluctuation were abstracted. Differences were analyzed using chi-squared test, Fisher's Exact test, and unpaired Student t-test. Mean amount of warfarin before and after surgery was 4.0 mg, 4.1 mg in Group A and was 5.1 mg, 4.6 mg in Group B, respectively. Average duration of warfarin doing before ablation was 73.7 days in Group A, 129.9 days in B with no significant difference (p = 0.312). The duration time of warfarin on groups after ablation lasted several months. The number of checking INRs was 4.1 and 7.6, respectively. Inter-individual variability of INR fluctuations were $2.1{\pm}0.6$ in Group A and $2.2{\pm}0.7$ in B which were not significantly different (p = 0.062). 164 cases of decreased INR were: 'omission in taking medication, stressfulness and headache, 'increased intake of high vitamin K foods', 'lifestyle change of increased physical activities', and 'increase of food-intakes'. To the contrary, 36 cases of increased INR were: 'reduce of food-intake', 'use of non-prescription drugs', 'reduction in physical activities', and 'excessive restriction on food-intake', consecutively. In conclusion, the study validated therapeutic outcomes of RA patients who we treated with standard guideline and demonstrated 9 factors of INR fluctuations in the patient. A well-trained, pharmacist-monitored anticoagulation service could reduce the risk of adverse effects and prevent complications in patients with AF around RA operation.

미국 FDA 허가사례를 통해 본 결핵균 및 비결핵 항산균 체외진단용 시약의 성능평가 (Performance Evaluation of In Vitro Diagnostic Reagents for Mycobacterium tuberculosis and Non-tuberculous Mycobacteria by FDA Approval)

  • 김연;박선영;김정호;장연희;하선목;최연임;이혜영
    • 대한임상검사과학회지
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    • 제50권1호
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    • pp.20-28
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    • 2018
  • 결핵(TB)은 Mycobacterium tuberculosis (MTB) 복합체의 구성원에 의한 세균 감염 질병이다. 결핵은 전 세계 인구의 1/3이 감염된 것으로 알려져 있으며, 한국에서는 매년 약 4만 명의 새로운 결핵환자가 발생한다. 또한, 비결핵 항상균 감염이 증가하고 있는 추세이다. 전통적인 결핵 및 비결핵 항상균 진단방법은 세균 배양으로 3~4주 이상이 소요된다. 따라서, 신속하고 정확한 결핵균(TB) 및 비결핵 항상균(NTM) 진단법의 필요성이 요구되고 있다. 결핵균 및 비결핵 항상균을 구분하기 위하여, 전 세계적으로 다양한 진단 방법이 개발되고 있다. 특히, 결핵균과 비결핵 항상균을 신속하고 정확한 동정의 요구가 증가함에 따라, 정확하고 신속하게 진단하기 위한 체외 진단 방법이 개발 되고 있다. 그러나 현재 결핵과 비결핵 항상균에 대한 체외 진단 시약의 성능 평가는 부족한 실정이다. 최근 식약청은 결핵균 및 비결핵 항상균 체외 진단 시약에 대한 가이드 라인을 발표했다. 본 연구에서는, 미국 FDA에 승인을 받은 결핵균 및 비결핵 항산균에 대한 체외 진단 시약의 성능을 검토하였다. 이 검토는 결핵균 및 비결핵 항상균 체외 진단 시약 평가에 유용한 참고 자료가 될것으로 사료된다.

Spargue-Dawley 랫드를 이용한 구미강활탕의 급성독성 연구 (Acute Toxicity Study on Gumiganghwal-tang(Jiuweiqianghuo-tang) in Sprague-Dawley Rats)

  • 신인식;김정훈;하혜경;서창섭;이미영;이호영;이준경;이남헌;이진아;이설림;허정임;신현규
    • 대한한의학방제학회지
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    • 제18권1호
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    • pp.79-85
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    • 2010
  • Objectives : This study was conducted to evaluate the acute toxicity and safety of Gumiganghwal-tang (Jiuweiqianghou-tang) in Sprague-Dawley rats though the current regulatory guideline. Methods : The preliminary study showed that the single oral administration of Gumiganghwal-tang(Jiuweiqianghou-tang) did not induce any toxic effect at a dose level of 2000 mg/kg. Based on the results, 2000 mg/kg was selected as the limited dose. In this study, 10 rats of each sex were randomly assigned to two groups of 5 rats each and were administrated singly by gavage at dose levels of 0 and 2000 mg/kg. Mortalities, clinical signs, and body weight changes were monitored for the 15-day period following administration. At the end of observation period, all animals were sacrificed and complete gross postmortem examinations were performed. Results : Throughout the study period, no treatment-related deaths were observed. There were no adverse effects on clinical signs, body weight, and gross findings at all treatment groups. Conclusions : These results showed that the single oral adminstration of Gumiganghwal-tang(Jiuweiqianghou-tang) did not cause any toxic effect at the dose levels of 2000 mg/kg in rats. In conclusion, the $LD_{50}$ of Gumiganghwal-tang (Jiuweiqianghou-tang) was considered to be over 2000 mg/kg body for both sexes.

Characterization of food allergies in patients with atopic dermatitis

  • Kwon, Jaryoung;Kim, Jungyun;Cho, Sunheui;Noh, Geunwoong;Lee, Sang Sun
    • Nutrition Research and Practice
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    • 제7권2호
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    • pp.115-121
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    • 2013
  • We examined the characteristics of food allergy prevalence and suggested the basis of dietary guidelines for patients with food allergies and atopic dermatitis. A total of 2,417 patients were enrolled in this study. Each subject underwent a skin prick test as well as serum immunoglobulin E (IgE) measurement. A double-blind, placebo-controlled food challenge was conducted using milk, eggs, wheat, and soybeans, and an oral food challenge was performed using beef, pork, and chicken. Food allergy prevalence was found among 50.7% in patients with atopic dermatitis. Among patients with food allergies (n = 1,225), the prevalence of non-IgE-mediated food allergies, IgE-mediated food allergies, and mixed allergies was discovered in 94.9%, 2.2%, and 2.9% of the patients, respectively. Food allergy prevalence, according to food item, was as follows: eggs = 21.6%, milk = 20.9%, wheat = 11.8%, soybeans = 11.7%, chicken = 11.7%, pork = 8.9% and beef = 9.2%. The total number of reactions to different food items in each patient was also variable at 45.1%, 30.6%, 15.3%, 5.8%, 2.2%, and 1.0% for 1 to 6 reactions, respectively. The most commonly seen combination in patients with two food allergies was eggs and milk. The clinical severity of the reactions observed in the challenge test, in the order of most to least severe, were wheat, beef, soybeans, milk, pork, eggs, and chicken. The minimum and maximum onset times of food allergy reactions were 0.2-24 hrs for wheat, 0.5-48 hrs for beef, 1.0-24 hrs for soybeans, 0.7-24 hrs for milk, 3.0-24 hrs for pork, 0.01-72 hrs for eggs, and 3.0-72 hrs for chicken. In our study, we examined the characteristics of seven popular foods. It will be necessary, however, to study a broader range of foods for the establishment of a dietary guideline. Our results suggest that it may be helpful to identify food allergies in order to improve symptoms in patients with atopic dermatitis.

Introduction of Questionnaires for Quality of Life of Patients with Malignant Tumors of the Central Nervous System into Neurosurgical Practice in the Republic of Kazakhstan

  • Akshulakov, Serik;Aldiyarova, Nurgul;Ryskeldiyev, Nurzhan;Akhmetzhanova, Zauresh;Gaitova, Kamila;Auezova, Raushan;Doskaliyev, Aidos;Kerimbayev, Talgat
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권2호
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    • pp.873-876
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    • 2016
  • Background: Studies of quality of life (QoL) of oncological patients is carried out using questionnaires approved in many international clinical studies. The European Organization for Research and Treatment of Cancer EORTC QLQ-C30 (Quality of Life Questionnary-Core 30) and its special brain cancer module EORTC QLQ-BN20 are widely used in the world neurooncologic practice. They are available in more than 80 official versions of 30 languages of the world. Previously we used the official versions in Russian, which often causes difficulty in understanding for native Kazakh language speakers, who comprise more than 60% of our respondents. This was the reason for creating a version of Kazakh language. Therefore, in 2014 for the first time the process of adaptation of questionnaires to the Kazakh language was initiated. Materials and Methods: The translation process of questionnaires to Kazakh language was held in accordance with the requirements of the European Organization for Research and Treatment of Cancer EORTC on QoL and consisted of the following stages: preparation - translation - pilot testing - approval. The official permission of authors and "Guideline on translation" was obtained which was developed by the working group of the EORTC on QoL. The pilot testing of EORTC QLQ-C30 and QLQ-BN20 questionnaires was conducted on the basis of the Department of Central Nervous System Pathology of the "National Centre for Neurosurgery" in patients with malignant tumors of the central nervous system. Results: The official versions of the EORTC QLQ-C30 and QLQ-BN20 questionnaires in Kazakh language were introduced and adapted in practical neurosurgical operations in Kazakhstan. Conclusions: The approved versions of the questionnaires in Kazakh language are now available for mainstream use on the official website EORTC.com. The versions of these questionnaires can be used in domestic cohort studies and clinical practice in the Republic of Kazakhstan. The use of these tools for assessing QoL will help professionals in the planning of individual treatment strategies and selection of the necessary therapy.

신생아 패혈증의 다양한 선별검사들의 진단적 가치 (Diagnostic value of various screening tests in neonatal sepsis)

  • 제현곤;정영미;정수진
    • Clinical and Experimental Pediatrics
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    • 제49권11호
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    • pp.1167-1173
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    • 2006
  • 목 적 : 신생아 패혈증을 진단하기 위해 단독 그리고 복합적인 다양한 선별검사를 분석하기 위해 일신기독병원의 신생아집중치료실에서 2001년 4월 1일부터 2005년 12월 31일까지 68개월 동안 시행했다. 방 법 : 패혈증의 임상증상이 있는 100명의 신생아와 증상이 없는 정상 신생아를 대상으로 연구를 시행했다. 신생아 패혈증의 진단을 위해 CRP, 총 백혈구 수, 총 호중구 수, 미숙호중구/총호중구 비(I/T비), 혈소판 수, 호중구의 변성, 다형 핵 백혈구에 대한 GAC를 사용했다. 결 과 : CRP는 A군에서는 50례 중 40례에서(86%) 양성이었고 B군에서는 50례 중 37례에서(74%) 양성이었으며 특이도는 94%였다. 총 호중구 수는 민감도와 특이도가 각각 A군에서는 72%와 86%였고 B군에서는 62%와 86%로 단일 검사상 민감도가 두 번째로 높았다. A군에서 GAC와 혈소판 수에 대한 각각의 민감도는 74%와 64%였다. A군과 B군에 대해 검사를 개별적으로 시행했을 경우와 함께 시행했을 경우에 대한 민감도, 특이도, 그리고 예측도를 계산했다. 결 론 : CRP, 총 백혈구 수, 총 호중구 수, 혈소판 수, 호중구의 변성과 다형 핵 백혈구에 대한 GAC는 신생아 패혈증이 없는 배양 검사 상 음성인 경우를 알아내는데 높은 민감도를 나타냈다. 더욱이 3가지 검사를 함께 시행할 경우에 민감도가 증가했다.

산전우울 임부를 위한 인지행동치료 프로그램의 효과: 체계적 문헌고찰 및 메타분석 (Effect of Cognitive Behavioral Therapy (CBT) for Perinatal Depression: A Systematic Review and Meta-Analysis)

  • 신현희;신영희;김가은
    • 한국산학기술학회논문지
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    • 제17권11호
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    • pp.271-284
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    • 2016
  • 본 연구는 임부의 산전우울에 대한 인지행동치료 중재의 효과를 검증하기 위해 수행된 체계적 문헌고찰 및 메타분석 연구이다. 데이터베이스는 CINAHL, PubMed, EMBASE 및 Koreamed, 국회도서관, 한국학술정보(Korean studies Information Service System, KISS), 한국의학논문데이터베이스 등 국내외 domain을 활용하였다. 검색은 ((Perinatal OR Antenatal OR Antepartum OR Pregnant) AND Depression) AND Women AND (CBT OR (Cognitive behavioral AND (Therapy OR Treatment)))와 '산전우울', '임부', '인지행동치료' 등의 검색어로 2016년 5월까지 출판된 문헌을 검토하였다. 분석은 R을 이용한 임의효과모형을 적용하여 산전우울과 불안의 효과크기를 각각 산출하였으며, 효과크기의 이질성을 검증하기위해 메타 ANOVA를 활용하여 조절효과분석을 실시하였다. 그리고 funnel plot, Egger's regression test, fail-safe N, trim-and-fill 분석을 활용한 출간오류분석과 민감성 분석을 실시하여 전체 연구 결과의 타당성을 검증하였다. 연구결과 총 180편의 문헌이 검색되었으며, 선택배제기준에 따라 최종적으로는 clinical trials 16편을 분석하였다. 분석에 포함된 개별문헌은 Scottish Intercollegiate Guideline Network (SIGN)의 checklist를 통해 비뚤림 위험을 평가하였으며, 대체로 비뚤림 위험은 낮았다. 연구결과 본 연구에서 중재의 산전우울에 대한 효과크기는 Hedges' g=-0.55(95% CI: -0.76~-0.33)로 통계적으로 유의하게 낮았으며, 불안에 대한 효과크기는 Hedges' g=-0.20(95% CI: -0.48~-0.08)이었으나, 통계적으로 유의한 차이는 없었다. 문헌의 이질성, 출판오류의 위험성 등은 낮았다. 본 메타분석결과에 의하면 인지행동치료는 임신부의 산전우울 증세 완화에 보통 정도의 효과가 있음이 밝혀졌다.

21세기 방사선종양학의 전망:최근의 진보와 한국에서의 발전 (Advances in Radiation Oncology in New Millennium in Korea)

  • 허승재;박찬일
    • Radiation Oncology Journal
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    • 제18권3호
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    • pp.167-176
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    • 2000
  • 최근의 방사선치료는 치료의 질을 향상시켜서 치료 후의 삶의 질을 높이는 것을 목표로 하고 있다. 국내에서도 방사선치료 환자와 치료 시설의 빠른 증가로 방사선종양학 분야는 많은 발전이 되고 있으며, 치료기술 또한 3-dimensional conformal radiotherapy의 보편화, liuac based stereotactlc radiosurgery의 활발한 적용과 luteuslty modulated radiation tferapy (IMRT)의 도입 준비 등 고난도의 치료 기술도입이 시도되고 있다. 저자는 최근 20년간 한국에서의 방사선 종양학의 발전을 조망하고 최근 발전되는 4차원적 방사선치료, IMRT의 현황, blologlcai conformailty치료의 개념, 항암제와 방사선치료의 병용에 대하여 살펴보고 최근 정보기술 혁명에 따른 인터넷과 방사선종양학 분야의 정보관리 시스템의 중요성 및 원격진료의 세계적 현황 등에 대해서 알아보고, 21 세기 한국에서의 방사선치료의 질을 올리기 위한 방법들을 제시하였다. 이들은 1) OA (qualify assurance) 향상, 2) 공동 프로토콜에 의한 3상 임상 연구의 필요성, 3) 특정 암에 대한 통일된 치료 프로토콜 또는 가 이드라인, 4) 전국적인 방사선종양학 관련 자료의 광역 data base구축과 중요 암에 대한 patterns of care study 등 시행의 필요성이다

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The preliminary study for three-dimensional alveolar bone morphologic characteristics for alveolar bone restoration

  • Cho, Hyun-Jae;Jeon, Jae-Yun;Ahn, Sung-Jin;Lee, Sung-Won;Chung, Joo-Ryun;Park, Chang-Joo;Hwang, Kyung-Gyun
    • Maxillofacial Plastic and Reconstructive Surgery
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    • 제41권
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    • pp.33.1-33.7
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    • 2019
  • Background: The concept of the ideal morphology for the alveolar bone form is an important element to reconstruct or restore the in maximizing esthetic profile and functional alveolar bone restoration. The purpose of this preliminary study is to evaluate the normal alveolar bone structure to provide the standard reference and guide template for use in diagnosing for implant placement, determining the correct amount of bone augmentation in actual clinical practice and producing prostheses based on three-dimensional imaging assessment of alveolar bone. Methods: This study was included 11 men and 11 women (average age, 22.6 and 24.5 years, respectively) selected from among 127 patients. The horizontal widths of alveolar bone of maxilla and mandible were measured at the crestal, mid-root, and root apex level on MDCT (multi-detector computed tomography) images reconstructed by medical imaging software. In addition, tooth dimensions of the central incisors, canines, second premolars, and first molars of maxilla and mandible, including the horizontal width of the interdental alveolar bone crest, were also measured and statistically analyzed. Results: The horizontal alveolar bone width of the palatal side of maxilla showed a distinct increment from the alveolar bone crest to the apical region in both anterior and posterior areas. The average widths of the maxillary alveolar ridge were as follows: central incisor, 7.43 mm; canine, 8.91 mm; second premolar, 9.57 mm; and first molar, 12.38 mm. The average widths of the mandibular alveolar ridge were as follows: central incisor, 6.21 mm; canine, 8.55 mm; second premolar, 8.45 mm; and first molar, 10.02 mm. In the buccal side, the alveolar bone width was not increased from the crest to the apical region. The horizontal alveolar bone width of an apical and mandibular border region was thinner than at the mid-root level. Conclusions: The results of the preliminary study are useful as a clinical guideline when determining dental implant diameter and position. And also, these measurements can also be useful during the production of prefabricated membranes and customized alveolar bone scaffolds.