• Title/Summary/Keyword: Clinical guideline

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Informed Consent' in Public Health Activities: Based on the Universal Declaration on Bioethics and Human Rights, UNESCO (공중보건 활동에서의 '사전 동의' 문제 - 유네스코 <생명윤리 및 인권에 관한 선언>을 중심으로 -)

  • Meng, Kwang-Ho
    • Journal of Preventive Medicine and Public Health
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    • v.41 no.5
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    • pp.339-344
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    • 2008
  • Objectives : The objective of this paper is to discuss the importance of obtaining informed consent for conducting epidemiological studies and public health activities, based on the Report of the UNESCO's Working Group on Informed Consent. Methods : The Report of the UNESCO's Working Group on Informed Consent was reviewed and discussed in connection with the ethical considerations of public health activities and epidemiological research. Results : It was at the Nuremberg Trial for the German war criminals of the Second World War that the principle of 'consent' was first stated as a consequence of the medical abuses carried out during the War. As a result of the Trial, the Nuremberg Code came out in 1947. Since then, various international declarations or ethical principles on 'informed consent' have been developed and published. These ethical principles on 'informed consent' have mostly to do with the clinical research that involves human subjects, and not with epidemiological studies and public health activities. However, UNESCO recently issued a comprehensive Report on Informed Consent based on the Universal Declaration on Bioethics and Human Rights adopted in 2005, and this included detailed guidelines on informed consent in epidemiological studies and public health activities. Conclusions : Universal Declaration on Bioethics and Human Rights emphasizes the principle of autonomy to protect the human rights of the human subjects involved in any public health activities and epidemiological research. As a practical guideline, obtaining informed consent is strongly recommended.

Factors in Selection of Surgical Approaches for Lower Lumbar Burst Fractures (하부 요추 방출 골절의 수술방법 결정시 고려 요인들)

  • Jahng, Tae-Ahn;Kim, Jong-Moon
    • Journal of Korean Neurosurgical Society
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    • v.29 no.8
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    • pp.1055-1062
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    • 2000
  • Objectives : Burst fracture of the lower lumbar spine(L3-L5) is rare and has some different features compare to that of thoracolumbar junction. Lower lumbar spine is flexible segments located deeply, and has physiologic lordosis. All of these contribute to making surgical approach difficult. Generally, lower lumbar burst fracture is managed either anteriorly or posteriorly with various fixation and fusion methods. But there is no general guideline or consensus regarding the proper approach for such lesion. We have tried to find out the influencing factors for selecting the surgical approach through the analysis of lower lumbar burst fractures treated for last 4 years(1994.3-1998.3). Method : This study includes 15 patients(male : 10, female : 5, age range 20-59 years with mean age of 36.7 years, L3 : 8 cases, L4 : 5 cases, L5 : 2 cases). Patients were classified into anterior(AO) and posterior operated(PO) groups. We investigated clinical findings, injured column, operation methods, and changes in follow-up radiologic study (kyphotic angle) to determine the considerable factors in selecting the surgical approaches. Results : There were 5 AO and 10 PO patients. Anterior operation were performed with AIF with Kaneda or Z-plate and posterior operation were done with pedicle screw fixation with PLIF with cages or posterolateral fusion. Canal compression was 46.6% in AO and 38.8% in PO. The degree of kyphotic angle correction were 10.7 degree(AO) and 8.5 degree(PO), respectively. There was no statistical difference between anterior and posterior operation group. All patients showed good surgical outcome without complications. Conclusion : Anterior operation provided good in kyphotic angle correction and firm anterior strut graft, but it difficulty arose in accessing the lesions below L4 vertebra. While posterior approach showed less correction of kyphotic angle, it required less time and provided better results for accompanied adjacent lesion and pathology such as epidural hematoma. The level of injury, canal compression, biomechanics, multiplicity, and pathology are considered to be important factors in selection of the surgical approach.

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A Case Study of Chronic Anal Fissure Treated With Chijasi-tang and Counseling (8년 동안 진행된 만성치열(Chronic anal fissure) 환자에게 치자시탕과 상담요법을 사용하여 호전된 치험 1례)

  • Lee, Soong-in;Cho, Min-seok;Lee, Sung-jun;Jeong, Jong-kil
    • Herbal Formula Science
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    • v.23 no.1
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    • pp.161-169
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    • 2015
  • Objectives : This study is aimed to report the outcomes of the treatment of a patient with chronic anal fissure during a 8-year period. Methods : Basic patient’s data was analyzed as a CARE guideline. And related psychological state was measured with BAI, STAI-X-II test. Results : The treatment is based on Shanghanlun and the patient reported better outcomes. The main symptoms of the patient were chronic constipation, blood in the stool. The main clinical findings were that the patient’s symptoms got worse during the examination period because of the anxiety of the exam. And loss of appetite and digestive disorders are due to Jue-Yin-Bing(厥陰病) and the clue of bleeding can be found in article 375 in Shanghanlun. The main diagnoses was chronic anal fissure and main interventions were Chijasi-tang according to article 375 in Shanghanlun and counseling on anxiety. As a results bleeding has stopped after taking herbal medicine and constipation has been treated at the same time. After 6 months, the patient performed BAI, STAI-X-II test and scores got lowered indicating decreasing anxiety level. Conclusion : Chijasi-tang with counseling achieved valid positive results to the patient with chronic anal fissure.

A 14-Day Repeated Dose Toxicity of Epimedii Herba Aqueous Extract Administered by Oral Gavage in F344 Rats

  • Han, Hyoung-Yun;Yang, Young-Su;Kim, Soo Nam;Han, Su-Cheol;Han, Kang-Hyun;Lee, Jong-Hwa;Jeong, Ja Young;Roh, Hang-Sik;Seok, Ji Hyeon;Kim, Jeong-Ah;Min, Byung-Sun
    • Natural Product Sciences
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    • v.21 no.1
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    • pp.34-41
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    • 2015
  • The objective of this study is to characterize a toxicity of Epimedii Herba (EH) in F344 rats and to find a dose levels for the 13 weeks toxicity study. EH is well known as medicinal herb in many Asian countries for traditional medicines of antibacterial and antiviral effects, estrogenic and antiestrogenic effects, and for treatment of osteoporosis, hypotensives, fatigue, kidney disorders, and related complications. However, the indispensable and basic information of toxicological evaluation of EH extract is insufficient to support its safe use. Therefore, we conducted toxicological evaluation of this drug in compliance with OECD and MFDS guideline in this study. The extract of EH was administered orally to F344 rats at dose levels of 0, 500, 1000, 2000, 3500, and 5000 mg/kg/day for 2 weeks. Each group was composed of 5 male and female rats. In this study, there were no treatment of EH-related adverse changes in clinical observations, mortality, body weights, food consumption, urinalysis, gross finding at necropsy, and organ weight examination. Total red blood cell count, hematocrit, mean corpuscular hemoglobin concentration, total cholesterol, and phospholipid were decreased in males and females at 5000 mg/kg/day compared to the control animals. Mean corpuscular volume and reticulocyte counts were increased in males and females at 5000 mg/kg/day compared to control animals. Therefore, we recommend that dose level of 5000 mg/kg/day is a highest treatment group in 13-week EH extract exposure study for further toxicity assessment.

Single Dose Toxicity Test of Bojungikkeehapdaechilkitang water extract in Male and Female ICR Mice (보중익기합대칠기탕(補中益氣合大七氣湯) 추출물의 ICR마우스에서 경구 단회투여독성 평가)

  • Bae, Young-Chul;Choi, Bin-Hye;Kim, Dong-Woo;Hur, Jin-Il;Kim, Dae-Jun;Byun, Joon-Seok
    • The Journal of Internal Korean Medicine
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    • v.26 no.2
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    • pp.369-378
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    • 2005
  • An herbal water extract of Bojungikkeehapdaechilkitang(BDT) was prepared to test it for single-dose and repeated-dose toxicity, genotoxicity and reproductive toxicity, and to obtain a 50% lethal dose$(LD_{50})$, approximated lethal dose(ALD), and approximated target organs for BDT. The extract was tested on female and male ICR mice according to KFDA Guideline 1999-61 at doasge level of 2000, 1000, 500, 250 and 125mg/kg/10mL In this study, clinical signs, mortalities and gross findings of principal organs were observed for 14 days of single dosing, and afterwards in some cases. The ALD and $LD_{50}$ of BDT extract obtained in this study was>2000mg/kg for both male and female ICR mice. Also, any possible digestive toxicity of BDT extract was found to be above 1000mg/kg in both male and female ICR mice. The results of this study strongly suggest that BDT extract has no toxic effect at dosage level below 500mg/kg.

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Effect of Serum Media on Fibroblast Proliferation and Collagen Synthesis (배양 혈청이 섬유아세포의 증식 및 교원질합성에 미치는 영향)

  • Lee, Min Ah;Seo, Sung Ig;Han, Seung Kyu;Kim, Woo Kyung
    • Archives of Plastic Surgery
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    • v.32 no.4
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    • pp.529-532
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    • 2005
  • Expanding cells ex-vivo is very important in tissue-engineering. Culture medium is usually supplemented with fetal bovine serum(FBS) in most of the experiments. However, cells grown in bovine serum media may posses the possibilities of disseminating bovine diseases and/or stimulating the patient's immune reactions. To overcome these problems, autologous or homologous serum should be used instead of the FBS. The purpose of this study is to compare cell proliferation and collagen synthesis depending on the kind of sera mixed on media and to provide a guideline on applying established experimental data to clinical cases. Human dermal fibroblasts were obtained from four patients. Five thousand cells per well in 96-well plates were incubated DMEM/F-12 Nutrient with varying serum mixture; 10% autologous serum, 10% homologous serum, and 10% FBS. Five days after incubation fibroblast proliferation and collagen production were determined by MTT assay and CICP enzyme immunoassay. The mean cell number were; $3.95{\times}10^4/well$, $2.97{\times}10^4/well$ and $2.30{\times}10^4/well$, respectively. The average amounts of collagen synthesized were; 238.13 ng/ml, 204.88 ng/ml, and 163.88 ng/ml in each. These results show that the use of human serum mixture may contribute to, not only preventing disseminated infection of bovine diseases. but also increase cell proliferation and collagen synthesis without simulating the patient's immune reactions.

The Stress Concentration Caused by Pin-hole in Femur after Computer-navigated Total Knee Arthroplasty: A Finite Element Analysis (컴퓨터 네비게이션을 이용한 슬관절 전치환술에서 핀 홀에 의한 응력 집중: 유한요소해석)

  • Park, Hyung-Kyun;Kim, Yoon-Hyuk;Park, Won-Man;Kim, Kyung-Soo
    • Journal of Biomedical Engineering Research
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    • v.29 no.6
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    • pp.451-456
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    • 2008
  • Total knee arthroplasty(TKA) using computer-assisted navigation has been increased in order to improve the accuracy of femoral and tibial components implantation. Recently, a few clinical studies have reported on the femoral stress fracture after TKA using computer-assisted navigation. The purpose of this study is to investigate the stress concentration around the femoral pin-hole for different pin-hole diameter, the modes of pin penetration by finite element analysis to understand the effects of pin-hole parameters on femoral stress fracture risk. A three-dimensional finite element model of a male femur was reconstructed from 1 mm thick computed tomography(CT) images. The bone was rigidly fixed to a 25 mm above the distal end and 1500 N of axial compressive force and 12 Nm of axial torsion were applied at the femoral head. For all cases, transcortical pin penetration mode showed the highest stress fracture risk and unicortical pin penetration mode showed the lowest stress concentration. Pin-hole diameter increased the stress concentration, but pin number did not increase the stress dramatically. The results of this study provided a biomechanical guideline for pin-hole fracture risk of the computer navigated TKA.

Cost-effectiveness Analysis of Pharmacologic Treatment in Hypercholesterolemia (고콜레스테롤혈증 치료 약물들에 대한 비용-효과 분석)

  • 정경래;문옥륜
    • Health Policy and Management
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    • v.9 no.3
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    • pp.70-94
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    • 1999
  • This paper was performed for a cost-effectiveness analysis of pharmacologic treatment of hypercholesterolemia. Agents modeled were cholestyramine, gemfibrozil. bezafibrate, lovastatin, pravastatin, simvastatin. Pharmacologic effectiveness was estimated by regression from reported clinical trials. Pharmacologic effects were expressed as the percent change of blood cholesterol level. Cost estimates included patients' travel expenses and time loss as well as resource consumption in the health care sector. Bezafibrate was the most efficient agent for reducing total cholesterol levels, having an cost over 1 year of ₩31.400 per percent reduction in total cholesterol. Simvastatin (10mg/d) was also efficient(₩33,100 per percent reduction). Chole styramine(8g/d) was least efficient at ₩90,200. For low-density lipoprotein cholesterol. simvastatin(10mg/d) was most efficient, at ₩23,200 per percent reduction, followed by lovastatin(20mg/d) at ₩28,000. Gemfibrozil was least efficient at ₩77,800 per percent reduction. For high-density lipoprotein cholesterol. bezafibrate(400mg/d) was most efficient at ₩39,300 per percent increase of high-density lipoprotein cholesterol. Cholestyramine was least efficient at ₩514,700. Analyses combining low-density lipoprotein cholesterol and high-density cholesterol effects suggest that bezafibrate(600mg/d) and simvastatin (10mg/d) were most efficient for reducing cardiovascular risk. The cost-effectiveness analysis results show that both simvastatin and bezafibrate could be efficient treatment. Simvastatin provide more effective treatment at higher cost, whereas bezafibrate is more cost-effective, as it may be less effective, at lower cost. Therefore, clinicians should choose reasonable treatment according to the patient's needs This pharmacoeconimc analysis will provide a guideline for efficient pharmacologic treatment and also be reference data for pricing new drugs.

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Recommended immunization schedule for children and adolescents: the Korean Pediatric Society, 2013

  • Jo, Dae Sun;Kim, Jong-Hyun;Choi, Eun Hwa;Park, Su Eun;Kim, Yae-Jean;Kim, Yun Kyung;Lee, Jina;Eun, Byung Wook;Lee, Soo Young;Lee, Hyunju;Kim, Ki Hwan;Kim, Kyung-Hyo;Korean Pediatric Society, Committee on Infectious Diseases
    • Clinical and Experimental Pediatrics
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    • v.56 no.6
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    • pp.231-234
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    • 2013
  • This article contains the recommended immunization schedule by the Committee on Infectious Diseases of the Korean Pediatric Society, updated in March 2013, when Haemophilus influenzae type b vaccine is now included in the National Immunization Program in Korea. It also includes catch-up immunization schedule for children and adolescents who are behind the recommended schedule. These schedules are a minor revision of the corresponding parts of Immunization Guideline, 7th edition, of the Korean Pediatric Society, released in 2012. Pediatricians should be aware of these schedules to provide adequate immunization to Korean children and adolescents.

Evaluation of the Quality of the Case Reports in Journal of Korean Medicine from Year 2015 to 2020 : Using CARE Guidelines (CARE 지침에 따른 대한한의학회지의 증례 보고에 대한 질 평가 연구: 2015년~2020년 증례 보고를 중심으로)

  • Hwang, Ji Hye;Ku, Jaseung;Nam, Eun-Young
    • The Journal of Korean Medicine
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    • v.41 no.2
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    • pp.80-95
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    • 2020
  • Objectives: The purpose of this study is to assess the quality of the Journal of Korean medicine case reports. Methods: Case reports published in the Journal of Korean Medicine from January 2015 to March 2020 were selected by using Oriental Medicine Advanced Searching Integrated System (OASIS) and the journal search system of the Korean Medical Association (https://www.jkom.org). The quality of the case reports was assessed using the Consensus-based Clinical Case Reporting Guideline Development (CARE) guidelines. Results: 33 case reports were selected for the assessment. Based on the CARE guidelines, 61.54% of the case reports included necessary information, but the quality level was uneven. More than 60% of the reports were missing data regarding 'Discussion of the strengths and limitations in your approach to this case', 'Intervention adherence and tolerability', 'Timeline', 'Medical, family, and psychosocial history including relevant genetic information', 'Patient perspective or experience', 'Adverse and unanticipated events', 'Administration of intervention', and 'De-identified demographic information and other patient specific information'. In most reports of over 90%, data regarding 'Diagnostic challenges', 'Intervention adherence and tolerability', and 'Key word' were not included. Conclusions: Efforts are needed to improve the quality of case reports in the Journal of Korean Medicine, and it is necessary to develop appropriate guidelines for case reporting for the Journal of Korean Medicine. In addition, all articles submitted to the Journal of Korean Medicine are to be complied with submission instructions and CARE guidelines.