사상체질 임상 연구자들의 임상연구에 관한 인식도 조사

유종향,장은수,이혜정,김윤영,김호석,이시우,Yoo, Jong-Hyang,Jang, Eun-Su,Lee, Hae-Jung,Kim, Yun-Young,Kim, Ho-Seok,Lee, Si-Woo 사상체질의학회 2008 사상체질의학회지 Vol.20 No.3

1. Introduction This study aims to survey knowledge and attitude of Sasang constitution investigators on the Sasang constitution clinical study. 2. Methods We have made up list of 24 Sasang constitution investigators who have conducted Sasang constitution clinical study before. The study has been surveyed for 20 investigators who has been experiencing clinical study bye-mail or interview. 3. Results 1) The recognition degree on clinical study for sasang constitutional investigators was relatively lower than that for non-oriental investigators. 2) Most investigators have difficulty in designing a Protocol and they thought Protocol is most important in clinical study. 3) The investigators has stressed the need of diagnosis guideline on Sasang Constitution in performing clinical study. 4. Conclusions Special course of clinical study for sasang constitutional investigators should be prepared to activate Sasang constitution clinical study. This course may set up the guideline of sasang constitution clinical study and designing protocol. Also it is urgent to develop constitution diagnosis guideline for clinical study.

동의신경정신과학회지에 게재된 임상연구논문 동향분석 -2001년부터 2010년까지-

허은정 ( Eun Jung Heo ),전원경 ( Won Kyung Jeon ),김우영 ( Wu Young Kim ),한창현 ( Chang Hyun Han ) 대한한방신경정신과학회 2011 동의신경정신과학회지 Vol.22 No.3

Objectives: This study was aimed to review the trend of clinical studies in Journal of Oriental Neuropsychiatry since 2001 to 2010. Methods: We collected 260 clinical studies and analyzed them for publish year, sorts of disease or symptoms, pattern identification diagnosis, and classification of clinical studies. Among them, we selected 46 clinical experimental studies and these studies were further analyzed for publish year, research institution, sort of disease or symptoms, sorts of treatments, number of subject, and pattern identification diagnosis. Results: The number of clinical studies in Journal of Oriental Neuropsychiatry have increased since the year of 2001. There were 62 kinds of diseases and symptoms and Hwa-Byung had the highest number of studies followed by depression, headache, insomnia and so on. The clinical experimental studies, which took up 17% of the clinical studies, have increased since 2001 and was varied with year. There were 13 reserch institutions for clinical experimental studies and they studied about stress, dementia, Hwa-Byung, and so on. Most of studies researched treatment about acupuncture, herb medicine, and meditation treatment for persons under 144. There are only 22% of studies using pattern identification diagnosis. Conclusions: For the development of oriental medicine for psychiatric disease, we need more qualifying clinical studies like RCT. We hope more researchers for psychiatry disease of oriental medicine will be interested in the publication of clinical studies and this will serve to produce advance of oriental medicine as evidence based medecine.

Overview of clinical study designs

Kim Seonwoo 대한응급의학회 2024 Clinical and Experimental Emergency Medicine Vol.11 No.1

The goal of a clinical study is to determine the factors associated with a disease and to assess the efficacy and safety of an investigational drug, procedure, or device. Since clinical study designs vary due to unique requirements of individual studies, the aims of this report are to educate researchers on the different types of studies and to assist researchers in choosing the optimal study type to fulfill their individual requirements. Clinical studies are classified into the two main types, observational studies and clinical trials, depending on the presence or absence of an intervention. Observational studies include case-control studies, cohort studies, and cross-sectional studies. Case-control and cohort studies may be prospective or retrospective, and case-control studies may be nested or not. Clinical trials may be pragmatic and may be controlled or noncontrolled; randomized or nonrandomized; open label or blinded; and parallel, crossover, or factorial. These observational and clinical trial designs are reviewed. Each type of clinical study has advantages and disadvantages. Therefore, researchers must consider these in choosing the design best suited for achieving their study objectives.

임상연구 특성요소가 IRB의 임상연구관리에 미치는 영향

지윤희,방준석,김영인,김경수,나현오 대한임상약리학회 2008 Translational and Clinical Pharmacology Vol.16 No.2

Background: The number of clinical trials which have been performed within Korea is increasing accompanied by the enlargement of the various responsibilities of each Institutional Review Board (IRB) in the way of providing adequate and on-time managerial involvements on the studies. Many confounding factors of each study can influence on the results with which delaying the final reports, or extending the review times associated with research-periods, or adjusting the alterations. Even though these factors were closely related to the results being managed by the IRBs, no in-depth research have been implemented to elucidate the correlations between these factors and the results necessitates IRBs’ managements. Methods: Study subjects were selected and analyzed retrospectively in a University hospital’s database. About 190 study projects which had been completed during 2005 to 2007 were retrieved and the characterized factors were classified into seven categories. Each category was analyzed and tested statistically by SAS program. Results: It is revealed that a large portion of the factors was subjected to the study profiles. The review-time showed extended tendency in the subjects which used medications (P=0.0174) required approval (P=0.0009) in phases ⅠⅡⅢ (P<0.0001) initiated by sponsors (P<0.0001) and with duration of 1 to 2 years (P=0.0442). Prior to submitting IRB, correction-times were multiplied specifically on the study subjects that used medications (P<0.0001) required approvals (P<0.0001), underwent phase ⅠⅡⅢ (P<0.0001) reviewed twice (P=0.0074) initiated by sponsors (P<0.0001) exceeded 2 years of period (P<0.0001) and required modifications before the submission (P=0.0001). Conclusion: Theclinical study projects characterize by ‘medication-used’, ‘sponsor-initiated’, ‘approval-required’, ‘duration period of 1 to 2 years’, and ‘under phase ⅠⅡ Ⅲ’ required thorough concerns and investigations from the beginning stage to reduce the time of review by the IRBs. Studies lasted more than 2 years entailed preparation of the sudden alterations to prevent the study duration. A new further study is necessary to analyze the frequency and the causes of the alterations in the study proposals. Background: The number of clinical trials which have been performed within Korea is increasing accompanied by the enlargement of the various responsibilities of each Institutional Review Board (IRB) in the way of providing adequate and on-time managerial involvements on the studies. Many confounding factors of each study can influence on the results with which delaying the final reports, or extending the review times associated with research-periods, or adjusting the alterations. Even though these factors were closely related to the results being managed by the IRBs, no in-depth research have been implemented to elucidate the correlations between these factors and the results necessitates IRBs’ managements. Methods: Study subjects were selected and analyzed retrospectively in a University hospital’s database. About 190 study projects which had been completed during 2005 to 2007 were retrieved and the characterized factors were classified into seven categories. Each category was analyzed and tested statistically by SAS program. Results: It is revealed that a large portion of the factors was subjected to the study profiles. The review-time showed extended tendency in the subjects which used medications (P=0.0174) required approval (P=0.0009) in phases ⅠⅡⅢ (P<0.0001) initiated by sponsors (P<0.0001) and with duration of 1 to 2 years (P=0.0442). Prior to submitting IRB, correction-times were multiplied specifically on the study subjects that used medications (P<0.0001) required approvals (P<0.0001), underwent phase ⅠⅡⅢ (P<0.0001) reviewed twice (P=0.0074) initiated by sponsors (P<0.0001) exceeded 2 years of period (P<0.0001) and required modifications before the submission (P=0.0001). Conclusion: Theclinical study projects characterize by ‘medication-used’, ‘sponsor-initiated’, ‘approval-required’, ‘duration period of 1 to 2 years’, and ‘under phase ⅠⅡ Ⅲ’ required thorough concerns and investigations from the beginning stage to reduce the time of review by the IRBs. Studies lasted more than 2 years entailed preparation of the sudden alterations to prevent the study duration. A new further study is necessary to analyze the frequency and the causes of the alterations in the study proposals.

류마토이드 관절염의 연구동향에 대한 소고(小考) -2004년 이후의 국내 학위논문 및 학회지 논문을 중심으로-

최용훈 ( Yong Hun Choi ),윤일지 ( Il Ji Yoon ) 한방재활의학과학회 2009 한방재활의학과학회지 Vol.19 No.2

Objectives: To research the trend of studies related to rheumatoid arthritis and to indicate the hereafter direction for its study in oriental medicine and its treatment. Methods: I reviewed 75 domestic oriental medical journals, and 50 medical journals about rheumatoid arthritis published after 2004, and comparative analysis was made. And these theses were classified by college, year, field of study, subject. Results: The following are the results of this study. 1. Classified by oriental medical college, Dae-jeon college published the most theses, followed by Dong-guk, Kyung-hee, Se-myung and Dong-shin college. Han-yang college published the most theses among college of medicine. 2. Classified by type of thesis, experimental theses(70 pieces, 94%) showed higher rate than that of clinical theses(4 pieces, 5%) in oriental medical studies. However, in medical studies, clinical theses(34 pieces, 68%) showed higher rate than that of experimental theses(15 pieces, 30%). 3. Analyzed by subject, the most dealt subject in oriental medicine was herb medication, followed by herbal acupuncture, single herb, electroacupuncture, sasang & gene, acupuncture & moxibustion, complex accordingly. The most dealt subject in medical clinical journals was standards of diagnosis & prognosis, followed by medication, gene analysis, pathogenesis, clinical pattern, operative treatment and complication accordingly. 4. In theses related to herb medication, most of the subject was to evaluate anti-inflammatory and immunoregulatory effects of herb medication with geopungseup, jibitong, hwalhyeolgeoer function. The tendency of experimental methods was focusing on understanding anti-inflammatory and immunoregulatory mechanisms through molecular biologic methods by analyzing cytokine and gene. 5. Most of theses related to herbal acupuncture were experimental studies verifying ant-inflammatory and immnoregulatory effects through methods observing change of cytokine and immunoregulatory factors. Regarding remedies for herbal acupuncture, Ulmus davidiana Planch was most preferred, followed by bee venom. 6. In theses related to single herb, Boik-yak was most prefered, followed by Geopungseup-yak and Hwalhyeolgeoer-yak. Regarding methods of research, there were tendency of shifting from methods verifying travail, anti-inflammatory and anti-pyretic effects through a test of behavior, morphometry, serology and temperature measurement of the rectum and the skin into verifying anti-inflammatory and immunoregulatory effects through observing inflammatory cytokine in the joint and cells of spleen. 7. In theses related to electroacupuncture, ST36 and adjuvant were most preferred as acupoints and induced factor. The tendency of experimental methods was turning from verifying mechanism of travail effect to analyzing inflammation and pain inducing factors. 8. Diverse medical clinical studies were published. Subjects such as diagnosis and prognosis, medication, gene analysis, clinical pattern, operational treatment, complication and pathogenesis were published. Especially, studies about standards of early diagnosis, and research on possible parallel medications with methotrexate were actively inquired. 9. Most of theses related to medical experimental studies was about mediators and receptors related to inflammatory induction and osteoclasia mechanism. Also, it was presented blockage of them can be effective on rheumatoid arthritis. Conclusions: The oriental medicine studies have merit in its diversity of treatment, but it clinical studies is lacking compared to experimental studies. Also, more diversity of subjects is necessary. Therefore, complementary measures are needed. Hereafter, oriental medicine research about rheumatoid arthritis needs more clinical research verifying the effectiveness and safety in clinical field. Also, we require oriental medical standard of diagnosis and researches on pathological generation which would make early checkup and prognosis possible.

최근 10년간 국내 뜸관련 연구에 대한 고찰

신정미,강미숙,송호섭 대한침구의학회 2009 대한침구의학회지 Vol.26 No.5

Objectives : This study is to research the trend of the Moxibustion-related studies and to establish the hereafter direction for the study on Moxibustion. Methods : We reviewed the domestic articles published last ten years(2000~2009). Results : We have searched 45 articles in 4 journals of Korean Acupuncture & Moxibusion, Korean Oriental Medicine, Korean Meridian & Acupoint, Korean Oriental Internal Medicine. 1. There were the most research done 2003, 2008. Both of them have 8 articles. In other years there were 2 or more articles. 2. The pattern of study was as follow: the clinical studies were 23, studies of phisical Characteristics and new moxibustion method were 9, the philological study were 5, the reviewed studies were 3, the experimental studies were 2 and the others were 5. The rate of clinical studies was increased. 3. In the clinical studies, the case-control study and non case-control study were more than case study. The disease after stroke were the most predominant. The rates of direct moxibustion and indirect moxibusion were similar. 4. After beginning 2000s, there were more studies of thermodynamic Characteristics. In the mid 2000s, there were more studies of new moxibustion method appearing. Conclusions : We need more studies about various kinds of diseases, side effect and aftereffects. There should be convenient and useful methods of moxibustion.

Pragmatic Clinical Studies: An Emerging Clinical Research Discipline for Improving Evidence-Based Practice of Cardiovascular Diseases in Asia

Dong Zhao,Chen Yao 대한심장학회 2022 Korean Circulation Journal Vol.52 No.6

Pragmatic clinical studies, an emerging clinical research discipline, include a wide range of studies that are largely embedded with routine clinical practice and aim to evaluate the comparative effectiveness and safety of different clinical intervention strategies. Increased availability and quality of electronic medical/health records drives the development of pragmatic clinical studies. In this review, we describe evolution of the conceptual framework of pragmatic clinical studies and share perspectives on the importance of pragmatic clinical studies in evidence-based practice for cardiovascular diseases, as a complement to conventional randomized controlled trials. We also highlight specific needs of pragmatic clinical studies in improving evidence-based practice for cardiovascular disease in Asian countries. The main challenges of pragmatic clinical studies are discussed briefly in this review.

해양문화콘텐츠 활용 사례 연구 : ‘제주해녀축제’를 중심으로

김은정 글로벌문화콘텐츠학회 2018 글로벌문화콘텐츠학회 학술대회 Vol.2018 No.1

2007년 10월, 제주의 가장 큰 축제인 탐라문화제의 부대행사로 시작한 ‘제주해녀축제’는 2010년부터 독립적으로 개최되어 올해로 11회를 맞이한다. 2016년 11월, 에티오피아에서 열린 제11차 유네스코 무형유산보호협약 정부간위원회에서 한국의 19번째 인류무형문화유산으로 ‘제주 해녀문화’ 등재가 최종 결정되었다. 인류무형문화유산은 공동체, 집단 및 개인들 문화유산의 관습, 재현, 표현, 지식과 기술뿐만 아니라 도구, 사물, 공예 및 공간 등 모두를 의미한다. ‘살아 있는 유산’으로서 ‘제주해녀문화’는 인류무형문화유산으로서는 물론 이를 활용한 콘텐츠로서도 매력적인 가치를 충분히 가지고 있다. ‘제주 해녀문화’는 해양문화에 속하고 ‘제주해녀축제’는 ‘제주 해녀문화’를 활용한 문화콘텐츠에 속한다. 이를 근거로 ‘제주해녀축제’를 해양문화콘텐츠 활용 사례로 보고 ‘제주해녀축제’가 지역적, 국내적인 축제에서 더 나아가 세계적인 메가 이벤트로 발전할 수 있는 활용방안에 대해 연구하였다.

비만에 대한 국내 한의학계의 최근 연구 동향 분석 - 2006년 이후 국내 학술지를 중심으로 -

박병윤,송윤경,임형호 한방비만학회 2010 한방비만학회지 Vol.10 No.2

Objectives Obesity is one of the most important health problem in modern society and constant studies are still in progress domestically without the effective treatment so far. The objective of this study is to analyze the recent trend of the studies about obesity in oriental medicine and to provide background for further studies. Methods All of the articles in the journal of 'Korean oriental association for study of obesity' were collected published after 2006. Search were conducted through 'http://oasis.kiom.re.kr' and the journal of 'the Korean academy of oriental rehabilitation medicine'(January 2006~October 2010) with the search word "obesity". Collected articles were classified into clinical study, experimental study, literary study, case report. Results Total 177 articles were analysed. The number of studies were increasing until 2008 and went down afterwards. According to the classification by the type of study, percentage of clinical study took 45.2%, experimental study took 31.6%, literary study took 14.7%, case report took 8.5%. Conclusion Domestic clinical studies and experimental studies are conducted more focused on the treatment and diagnosis of obesity. Future study on the obesity should be focused on the prevention in the aspect of public health and social cost.

다기관 전향적 임상연구를 위한 웹 데이터베이스 시스템

김혜림,최신영,유은미,박지숙 서울여자대학교 2010 정보기술논문지 Vol.8 No.-

Because many centers jointly select the subject, multi-center clinical study can promptly recruit various patient groups into the research, thus being advantageous in terms of generalization. However, prospective clinical study has difficulties in implementation, because it takes a lot of efforts to trace a large scale of subjects. The purpose of this study is to develop a web database system suitable for multi-center prospective clinical study. This study has presented three basic strategies-accurate data input, easy data tracing, and real-time data verification-to supplement the demerits of prospective clinical study. The developed system has been applied in the clinical study proceeded by the study group for Respiratory failure which is affiliated to The Korean Academy of Tuberculosis and Respiratory Diseases's Association for Research on Respiratory Failure and has been verified of its performance.