• 제목/요약/키워드: The medicine approval

검색결과 220건 처리시간 0.024초

원발성(原發性) 월경곤난증(月經困難症)과 어혈(瘀血)의 상관성 연구 (A study on the Correlation between Primary dysmenorrhea and Blood stasis)

  • 윤영진;조정훈;장준복;이진무;이창훈;이경섭
    • 대한한방부인과학회지
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    • 제22권1호
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    • pp.148-160
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    • 2009
  • Purpose: We intended to observe the correlations between Primary dysmenorrhea severity and Questionnaires for Blood Stasis Pattern. Methods: After initial approval by Kyung-Hee University Oriental Medical Hospital Institutional Review Board of Clinical Trials, volunteers for the clinical trial were recruited. We selected the 52 primary dysmenorrhea patients by the screening tests (clinical examination and inquiry). The severity of dysmenorrhea was evaluated by VAS (Visual Analog Scale), VRS (Verbal Rating Scale) & MVRS (Multidimensional Verbal Rating Scale). The severity of Blood Stasis was evaluated by Questionnaires for Blood Stasis Pattern. For statistics, we used Spearman's rho correlations, SPSS 13.0 for windows. Results: In case of VAS, though two items (眼瞼下靑紫, 便黑) of Questionnaires for Blood Stasis Pattern were correlated, total score & discriminant function score of Questionnaires for Blood Stasis Pattern were not correlated. In case of VRS, though two items (小腹痛, 夜間痛) of Questionnaires for Blood Stasis Pattern were correlated, total score & discriminant function score of Questionnaires for Blood Stasis Pattern were not correlated. In case of MVRS, though one items (久痺症) of Questionnaires for Blood Stasis Pattern were correlated, total score & discriminant function score of Questionnaires for Blood Stasis Pattern were not correlated. Conclusion: Though the results showed partial correlation of Primary dysmenorrhea severity and Questionnaires for Blood Stasis Pattern, we need further study after improvement and complementation of Questionnaires for Blood Stasis Pattern.

The Fok1 Vitamin D Receptor Gene Polymorphism and 25(OH) D Serum Levels and Prostate Cancer among Jordanian Men

  • Atoum, Manar Fayiz;AlKateeb, Dena;Mahmoud, Sameer Ahmed AlHaj
    • Asian Pacific Journal of Cancer Prevention
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    • 제16권6호
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    • pp.2227-2230
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    • 2015
  • Background: Prostate cancer (PCa) is one of the most commonly diagnosed neoplasms and the second leading cause of cancer death in men in the Western world. Vitamin D (1,25dihydroxy vitamin D) is linked to many biological processes that influence oncogenesis but data on relations between its genetic variants and cancer risk have been inconsistent. The aim of this study was to determine associations between a vitamin D genetic polymorphism and 25-hydroxyvitamin D [25(OH)D] levels and prostate cancer. Materials and Methods: Genomic DNA was extracted from 124 Jordanian prostate cancer patients and 100 healthy volunteers. Ethical approval was granted from the ethical committee at Hashemite University and written consent was given by all patients. PCR was used to amplify the vitamin D receptor Fok1 polymorphism fragment. 25(OH)D serum levels were measured by competitive immunoassay. Results: All genotypes were in Hardy-Weinberg equilibrium. Genotype frequency for Fok1 genotypes FF, Ff and ff was 30.7%, 61.3% and 8.06%, for prostate cancer patients, while frequencies for the control group was 28.0%, 66.0% and 6.0%, respectively, with no significant differences. Vitamin D serum level was significantly lower in prostate cancer patients (mean 7.7 ng/ml) compared to the control group (21.8 ng/ml). No significant association was noted between 25(OH)D and VDR Fok1 gene polymorphism among Jordanians overall, but significant associations were evident among prostate cancer patients (FF, Ff and ff : 25(OH)D levels of 6.2, 8.2 and 9.9) and controls (19.0, 22.5 and 26.3, respectively). An inverse association was noted between 25(OH)D serum level less than 10ng/ml and prostate cancer risk (OR 35.5 and 95% CI 14.3- 88.0). Conclusions: There is strong inverse association between 25(OH)D serum level less than 10ng/ml level and prostate cancer risk.

Evaluation of BCL6 and MUM1 Expression in Patients with Diffuse Large B cell Lymphoma and their Correlations with Staging and Prognosis in Iran

  • Rahimi, Hossein;Jafarian, Amirhossein;Samadi, Alireza;Meamar, Bahram;Rahmani, Shaghayegh
    • Asian Pacific Journal of Cancer Prevention
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    • 제16권1호
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    • pp.83-86
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    • 2015
  • Background: Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkins lymphoma (NHL), accounting for approximately 25% of NHL cases. The aim of this study was to evaluate the association between the BCL6 and MUM1 gene expression and patient prognosis and stage. Materials and Methods: After ethical approval, in a cross-sectional study, tissue samples of 80 patients with diffuse large B-cell lymphoma were analyzed for BCL6 and MUM1 gene expression. Immunohistochemical staining was performed with division into categories of 0-5%, 5-25%, 26-50%, 51-75% and more than 75%. Other clinical and histological information such as lymph node involvement, T-stage, B symptoms and patient outcome were also recorded. Data were analyzed with SPSS version 16 and a P-value less than 0.05 was considered significant. Results: The patient mean age was $46.9{\pm}10.5$ years ($47.6{\pm}10.7$ and $46.1{\pm}9.6$ for males and females, respectively). A significant association was seen between lymphoma stage and BCL6 (p=0.045) but not MUM1 expression (p=0.09). However, the latter was associated with mortality (p=0.006) as was also the BCL6 level (p=0.006). Conclusions: : Overexpression of MUM1 and BCL6 is associated with poor prognosis in patients with diffuse large B-cell lymphoma.

개에서 Malassezia 피부염에 대한 itraconazole 치료 18례 (Efficacy of itraconazole in 18 cases of Malassezia dermatitis in dogs)

  • 정아영;허우필;정효훈;엄기동;이근우;오태호
    • 한국임상수의학회지
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    • 제22권2호
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    • pp.90-93
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    • 2005
  • Malassezia 피부염으로 진단된 18두의 개를 대상으로 Itraconazole 5mg/kg을 1일 2회 경구 투여하여 치료효과를 알아보았다 치료반응을 보인 환자는 $88\%$이었으며 소양감과 피부병면은 치료후 1주일에 확연히 개선되었다. 치료대상견의 품종은 Haltese$(22\%)$, Cocker Sptuiel$(17\%)$, Pekingese$(11\%)$, Vizsla$(11\%)$이었다. 피부증상으로는 가피$(31\%)$, 탈모$(25\%)$, 색소침착$(25\%)$, 인설$(19\%)$, 발적$(13\%)$, 태선화$(11\%)$, 농포$(11\%)$ 귀부종$(11\%)$, 구진$(5\%)$의 순으로 냐타났다. 병변발생부위는 이도$(41\%)$, 액와부$(18\%)$, 서혜부$(15\%)$, 회음부$(12\%)$, 복측경부$(9\%)$, 지간부$(1\%)$, 총구부$(1\%)$ 이었다. 세포학적 검사시$61\%$의 환견에서 구균이 동시에 검출되었다. Itraconazole에 대한 임상반응은 $89\%$가 치료반응을 보였고 (2두)$11\%$는 치료반응을 보이지 않았다 치료반응을 보인 환자 중 5두는 재발되었고 1두는 갑상선 기능저하증이었으며 나머지 4두는 재발의 원인을 확인할 수 없었다. 1두에서 투여 후 28일에 식욕결집, 침울의 증상이 발현되어 투약을 중지하였다. 따라서itraconazole을 5mg/kg을 1일 2회 경구투여는 Malassezia 피부염에 효과적인 치료로 사료된다

의약품 임상시험에서 피험자 보호 (A Study on the Protection of Trial Subjects in Clinical Trials of Investigational New Drug)

  • 위계찬
    • 의료법학
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    • 제13권2호
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    • pp.79-113
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    • 2012
  • This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.

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전략환경평가를 통한 환경영향평가제도 개선에 대한 인식도 조사 연구 (A Study of Perception on Improvement of Environmental Impact Assessment using Strategic Environmental Assessment)

  • 김임순;김윤신;문정숙;한상욱;손부순
    • 환경영향평가
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    • 제13권3호
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    • pp.125-135
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    • 2004
  • Environmental Impact Assessment(EIA) in Korea has been used to improve environmental conservation and decision-making. Since environmental impact statement(EIS) was introduced in 1981 with the promulgation of the Environmental Preservation Act in 1977, which replaced the Pollution Control Act legislated in 1963. With a rapid growth of environmental perception as well as the diversification of development activities, however, it has recently bring about a strong demand for a new assessment process related to the strategic level of policies, plan, programs. Method of this study includes analyses of the situation of local EIA and its problematic issues through survey and analysis of information and data, analysis of the level of environmental awareness of professionals and case studies including analysis of foreign strategic environmental assessment. Accordingly, I have elicited a concept of SEA. In addition, I have studied on costs of environmental assessment, and efficiency of internalization of HIA. The survey was carried between September and November 2003, and 177 professionals were asks to complete a questionnaire. As a result of questionnaire survey of environmental pundits, it revealed that 83.8% of participants were in favor of introduction of strategic assessment. This result demonstrated more or less higher approval rate than those of awareness survey done by the Ministry of Environment, i.e. 86.0% ayes, and 14.0% nays. 22.8% of participants agreed to the opinion; "For introduction of this system, earlier is better," 50% reported having an opinion such as, "Will introduce this system in an earliest possible time after correcting problems," 26.3% reported having an opinion such as, "Let's decide the time for introduction of this system after correcting problems first,' and 0.9% reported having an opinion, "it's too early to introduce this system." Specifically, the ratio of ayes on introduction of the system marked 72.8%, and it revealed that a majority of respondents have an opinion such as, "Will introduce this system in an earliest possible time after correcting problems." As means of solutions for the problem regarding the limits of applications that existed in SEA System, factors, such as collecting a wide variety of opinions, securing experts, and faithful implementation, etc. were reported important, and in addition to these factors, respondents revealed having opinions such as, consistent research and development, reflection of public interest, establishment of professional organization, enforcement of after-management service, expanding investments in large, systemizing reference materials, and encouraging public participation, etc. To improve problems involving with present EIA system, it has been identified through this study that SEA is efficient and useful. In order to have SEA introduced successfully, it has been cleared that internalization of effectiveness of environmental cost together with HIA must be accomplished.

입원환자가 인지하는 간호요구도와 간호만족도의 관계에 영향을 미치는 간호사 의사소통 매개효과 (The Mediating Effect of Nurse's Communication on the Relationship between Nursing Needs and Nursing Satisfaction in hospital patients.)

  • 최운정;강지숙
    • 한국산학기술학회논문지
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    • 제19권4호
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    • pp.374-382
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    • 2018
  • 본 연구는 입원환자의 간호요구도와 간호만족도의 차이를 줄이고 간호만족도에 영향을 줄 수 있는 의사소통 유형을 파악하며, 간호요구도와 간호만족도의 관계에서 의사소통에 대한 매개효과를 확인하여 간호서비스 향상을 위한 기초자료로 활용하고자 시행되었다. 본 연구는 IRB 승인 후 대학병원 입원환자 180명을 대상으로 설문지를 통해 자료가 수집되었다. 자료수집 기간은 대상으로 2017년 4월부터 6월까지 이었고, SPSS 22.0 통계 프로그램을 통해 자료분석을 수행하였다. 연구결과 대상자가 인지하는 간호사 의사소통 유형은 $3.88{\pm}0.52$점이었고, 대상자가 인지하는 간호요구도 $3.93{\pm}0.55$점으로 간호만족도 $3.74{\pm}0.58$점에 비해 유의하게 높았다. 대상자의 간호요구도는 입원병실에 따라 간호사 의사소통과 간호만족도의 유의한 차이를 나타내었고, 간호사 의사소통와 간호요구도(r=.286, p<.001), 간호사 의사소통과 간호만족도(r=.524, p<.001), 간호요구도와 간호만족도(r=.488, p<.001)에서 유의한 정적인 관계를 나타내었다. 입원환자가 인지하는 간호요구도와 간호만족도의 관계에서 간호사 의사소통은 부분매개효과가 있었다(Sobel test Z=2.450, p=.014). 이상의 결과를 토대로 간호사를 위한 지속적인 의사소통 강화교육 프로그램개발과 입원병실의 사생활보호를 강화하고 환자와 간호사가 의사소통을 충분히 할 수 있도록 간호인력을 충분히 확보하려는 노력이 필요하다.

고해상도 조영증강 삼차원 회손기울기 회상 영상을 이용한 측면연수경색 환자의 두개내 척추동맥 및 뒤아래소뇌동맥 평가 (High-Resolution Contrast-Enhanced 3D-Spoiled Gradient-Recalled Imaging for Evaluation of Intracranial Vertebral Artery and Posterior Inferior Cerebellar Artery in Lateral Medullary Infarction)

  • 윤영노;안성준;서상현;박아영;정태섭
    • Investigative Magnetic Resonance Imaging
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    • 제18권1호
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    • pp.17-24
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    • 2014
  • 목적: 측면연수경색 환자의 두개내 척추동맥 및 뒤아래소뇌동맥 평가에 있어 고해상도 조영증강 삼차원 회손기울기에 코 회상영상의 역할 규명하고자 한다. 대상과 방법: 임상시험심사위원회에서 승인한 측면연수경색으로 확진된 25명의 환자를 대상으로 하였다. 모든 환자는 3T 자기공명 영상을 이용한 고해상도 조영증강 삼차원 회손기울기에코 회상영상과 조영증강 자기공명 혈관조영술을 받았다. 두 명의 영상의학과 의사는 환자의 임상정보와 확산강조영상 없이 두개내 척추동맥 및 뒤아래소뇌동맥에 있는 동맥병변을 평가하였다. 두개내 척추동맥과 뒤아래소뇌동맥의 병변 동반유무에 따라 임상정보와 측면연수경색의 넓이, 소뇌경색 동반여부를 비교하였다. 결과: 총 25명의 환자 중 22명의 환자가 고해상도 조영증강 삼차원 회손기울기에코 회상영상으로 두개내 척추동맥 및 뒤아래소뇌동맥에서 박리, 죽종, 혈전색전증을 보였다. 그러나 그 중 12개의 뒤아래소뇌동맥의 병변은 조영증강 자기공명 혈관조영술에서 보이지 않았다. 추가적인 소뇌경색은 두개내 척추동맥과 뒤아래소뇌동맥에 병변이 있을 경우 두개내 척추동맥에만 병변이 있는 경우보다 빈번하게 나타났다. 결론: 고해상도 조영증강 삼차원 회손기울기에코 회상영상은 측면연수경색 환자의 두개내 척추동맥 및 뒤아래소뇌동맥의 병변평가에 도움을 줄 수 있다.

교원 성과급 제도에 대한 초등교사와 초등보건교사의 인식과 개선방안 (A Study on the Perception and Improvement Plans of Performance Based Pay System of Elementary School Teachers and Elementary School Health Teachers)

  • 여순영;김윤신;김현숙
    • 한국학교보건학회지
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    • 제24권2호
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    • pp.141-154
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    • 2011
  • Purpose: The purpose is to provide basic information for establishing improvements on performance-based pay's evaluation method of health teachers. Methods: For subjects, 200 teachers at public elementary schools and 200 health teachers at public elementary schools in Gyeonggi-do were conveniently sampled, and then surveyed through a questionnaire. The questionnaire was to recognize recognition of teachers working under the teacher's performance-based pay system, which was quoted in the questionnaire of Choi ji-hye (2005) and Lee mi-gyeong (2008). Inquiry for the recognition of teachers on evaluation of health teacher's performance-based pay system and improvements on the performance-based pay's evaluation method of health teachers were used after consultation with five incumbent health teachers and a review with the thesis director. Results: The performance-based pay's evaluation method of health teachers has the same method with general teachers in schools, so it is not fair to evaluate the performance of health teachers. The ways to improve the performance-based pay evaluation method of health teachers is as follows: first, the approval on improving 'the number of class hours' which is a detailed item of a teacher's performance evaluation criterion to 'the number of health lesson hours per week and the number of students visiting the school infirmary per week'; second, improving 'life guidance' into 'counseling results of medically-treated students, parents of students and personal hygiene guidance'; third, improving 'a teacher in charge' into 'awarding of points by being recognized as a health teacher in charge of all students and considering the economic situation of the region,; forth, improving 'difficulty of position' into 'the number of health-teacher's annual promotion task items and the treatment number of issuing and receiving of official documents', and improving the 'task difficulty' into 'importance and urgency of emergency patient management, risk level and urgency of infectious diseases and avoiding work in charge' appeared to be more than 90% respectively. Conclusion: The performance-based pay system of teachers being carried out every year should be executed by preparing fair evaluation criteria suitable for task properties and the role of health teachers with different evaluation criteria compared to general teachers.

미국 전문간호사(NP)의 역할과 교육과정에 관한 고찰 (Nurse Practitioner Roles and Curriculums in the United States)

  • 이선옥
    • 한국간호교육학회지
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    • 제5권1호
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    • pp.97-105
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    • 1999
  • Based on literature, status and role of the NP in America was reviewed. The process of developing NP program in America suggests us many things. In America, nurse practitioners have sustained a mutually beneficial status with their patients for over thirty years. Excel fence in academic education and clinical training will enable nurse practitioners to continue to provide quality health care. The magnitude changes in the health care system of the United States, the challange of providing real access of health care continues. Lack of access to adequate primary care was the driving force in the initial 1965 Federal Involvement in developing the NP role. In 1993 President Bill Clinton's health care reform initiative provided policy support for NPs as primary care providers. The Institute of Medicine explicitly recognized NPs as an integral part of the primary care team. In addition, several national reports recognized NPs as affordable, accessible, high-quality care providers. The recent passage of direct Medicare reimbursement for NPs reflected public policy statements coincided with and likely contributed to a growth spurt in the NP workforce. From 1965 to 1977 NP programs offered traditional primary care clinical tracks(adult, family, woman's health, and pediatrics) for relatively small clusters of students in a variety of institutional settings. From 1978 to 1990 these educational programs were incorporated into graduate schools of nursing. By 1990 the majority of NPs received educational preparation in master's-level nursing programs. A new emphases was placed on postmaster's NP programs designed for master's prepared clinical nurse specialists and nurse managers. he the health care system shifted hospital nursing resources toward community-based care, these master's -level nurses sought additional NP preparation. NP educational programs are defined as the educational structure in which one or more NP clinical tracks are offered. NP clinical tracks, in turn, offer curriculum and supervised clinical experiences that match standards in specific practice areas such as family(FNP), adult(AUP), geriatrics(GNP), pediatrics(PNP), women's health (WHNP), neonatal (NNP), and acute care(ACNP). There were indications that NP practice was expanding into new clinical areas as evidenced by new types of tracks, particularly in acute care and psychiatry. The increase in acute care NP students likely reflects the increased demand from hospitals and other acute care settings. In Korea, change of nurse's role into nurse practitioner's role may have many difficulties. The need of health consumer, policy support of government, approval of medical care team are all essential component. Every nursing personnel make effort to planning the new health care delivery system.

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