• Title/Summary/Keyword: Clinical Circumstances

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Correlation of SUV According to the Body Weight and Body Surface Area in PET/CT Imaging (PET/CT 검사 시 체중과 체표면적에 따른 SUV의 상관관계)

  • Park, Ju-Seon;Do, Yong-Ho;Kim, Jung-Soo;Lee, Hong-Jae;Kim, Jin-Eui
    • The Korean Journal of Nuclear Medicine Technology
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    • v.17 no.2
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    • pp.44-47
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    • 2013
  • Purpose: There are several methods of measuring SUV in PET/CT imaging including $SUV_{bw}$ which uses the body weight, $SUV_{bsa}$ which that uses body surface area and $SUV_{lbm}$ which uses lean body mass. Currently, Seoul National University Hospital uses $SUV_{bw}$ method which minimizes the variability. In this study, we compared and analyzed the correlation between $SUV_{bw}$ and $SUV_{bsa}$ according to patients' body mass index. Materials and Methods: Using Biograph mCT40 (Siemens, Germany), we conducted $^{18}F-FDG$ PET/CT imaging on 70 patients (41 males, 29 females; ages $58.04{\pm}12.44$). We classified the patients as underweight (BMI<20), normal weight (20$${\leq_-}$$BMI<25), overweight (25$${\leq_-}$$BMI<30), obese (30$${\leq_-}$$BMI<35) and severely obese (35$${\leq_-}$$BMI) according to the patient's sex, age and BIM. Then, bone, liver and lungs were set as ROI for calculation of maximum values of $SUV_{bw}$ and $SUV_{bsa}$, through Syngo.via VA11A analysis program. Results: Comparing the five groups divided according to the BMI by the standard differences between $SUV_{bw}$ to $SUV_{bsa}$, $SUV_{max}$ was measured to be $0.66{\pm}0.15$, $0.78{\pm}0.35$, $0.77{\pm}0.21$, $1.00{\pm}0.44$, $1.53{\pm}0.38$ for bones in underweight, normal weight, overweight, obese and severely obese groups, respectively. For liver, values of $SUV_{max}$ were $1.64{\pm}0.16$, $2.06{\pm}0.34$, $2.19{\pm}0.21$, $2.52{\pm}0.21$ and $2.74{\pm}0.40$ in the same order. And for lung, values of $SUV_{max}$ were $0.69{\pm}0.33$, $0.54{\pm}0.17$, $0.62{\pm}0.23$, $0.83{\pm0.29}$, $1.03{\pm}0.30$. Conclusion: By comparing and analyzing the differences between $SUV_{bw}$ and $SUV_{bsa}$ in this study, it was found that the differences between $SUV_{bw}$ and $SUV_{bsa}$ increased as patient's BMI increased. Thus, there is room for error in the values of SUV depending on the methods of calculations, and appropriate methods must be applied according to the circumstances in clinical settings.

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The Study of Comparative Legal Review According to Data Exclusivity of Pharmaceutical Marketing Authorization - In preparation for the development of drugs and vaccine of COVID-19 - (의약품 자료독점권(Data Exclusivity)에 대한 비교법적 고찰 - COVID-19 치료제 및 백신 개발을 대비하여 -)

  • Park, Jeehye
    • The Korean Society of Law and Medicine
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    • v.21 no.1
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    • pp.223-259
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    • 2020
  • With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

A study on improvement of misdiagnosis rate in aortic regurgitation disease by physically correcting EF in 2D echo cardiography (대동맥판 역류질환 진단시 이면성심초음파 박출계수의 보정을 통한 오진율 개선에 관한 연구)

  • Choi, Kwan-Woo;Son, Soon-Yong
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.13 no.5
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    • pp.2142-2147
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    • 2012
  • This study is aimed at decreasing wrong diagnosis with corrected EF(Ejection Fraction) of 2D echo cardiography by analysing the physical time-resolution difference between Cine MRI and 2D echo cardiography and applying the corrected EF in 2D echocardiography. From February 2010 to December 2011, among the 110 patients who had undergone both 2D echo cardiography and cine MRI only 37 patient were selected suffering aortic valve regurgitation. ED, ES and SV were measured and EF was calculated in each system while normal ranges of Cine MRI and 2D echocardiography were compared to evauate misdiagnosis rate. The correlation of physical time resolution between 2D echocardiography and MRI was evaluated and the differences were corrected with linear regression coefficient which is derived from linear regression analysis. Blandt-Altman plot was used to evaluate the reliability of corrected 2D echo cardiography EF and compare the error among measured values. The values were compared with MRI normal range and misdiagnosis rate was measured again. As a result, misdiagnosis rates of physical time resolution were measured to be 32.4%(12people) before the correction of EF and 18.9%(7people) after the correction. Also, EF confirmed in Blandt-Altman plot were almost the same with MRI EF. In conclusion, when diagnosing aortic regurgitation disease, simply using 2D echocardiography can easily raise the misdiagnosis rates, therefore considering the MRI machine's physical merits, correcting the time resolution difference is important by calculating time resolution wrong diagnosis would decrease and it is considered to be useful in clinical circumstances.

Change in the Korean Fertility Control Policy and its Effect (출산력 억제정책의 영향과 변천에 관한 고찰)

  • Hong, Moon-Sik
    • Korea journal of population studies
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    • v.21 no.2
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    • pp.182-227
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    • 1998
  • Korean government decided to adopt an explicit population control policy in 1961 and from the following year the establishment and operation of the national family planning programme was included in each of the Five-Year Economic Development Plans that began in 1962. This policy was pursued in the understanding that without proper population control measures korea could not be able to achieve economic development. Korean national family planning programme is characterized by contraceptive target system through public health network with distribution of free contraceptives by family planning field workers and clinical contraceptive services such as IUD, vasectomy and tubaligation at designated clinics by the government. In addition, IE&C activities by the Planned Parenthood Federation of Korea and programme evaluation and research by the Korea Institute for Health and Social Affairs contributed to the development of the government programme. Between 1960 and mid 1980s the nation's total fertility rate was reduced from 6.0 to population replacement level of 2.1 and thereafter it has been maintained at 1.6 to 1.7 of below replacement level. With a short period of less than three decades fertility transition was completed in Korea. It is estimated that if the current level of below replacement fertility continues, the population in Korea stabilize at around 52.78 million people by the year 2028, and it will begin to decrease thereafter. Under this circumstances, the government adopted new directions and strategies of the population policy in June 1996, focused primarily on population quality and social welfare than on demographic arenas. In spite of over 80 percent of high contraceptive prevalence among married women, high incidence of induced abortions is maintained. Moreover, the prevalence of sex selective induced abortions using procedures to determine the sex of the fetus has resulted in an imbalance in the sex ratio at birth. In order to overcome those problems associated with reproductive health new policy for population quality control and health promotion programme should be highly strengthened in the future.

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A Study on Differences of Opinions on Home Health Care Program among Physicians, Nurses, Non-medical personnel, and Patients. (가정간호 사업에 대한 의사, 간호사, 진료관련부서 직원 및 환자의 인식 비교)

  • Kim, Y.S.;Lim, Y.S.;Chun, C.Y.;Lee, J.J.;Park, J.W.
    • The Korean Nurse
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    • v.29 no.2
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    • pp.48-65
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    • 1990
  • The government has adopted a policy to introduce Home Health Care Program, and has established a three stage plan to implement it. The three stage plan is : First, to amend Article 54 (Nurses for Different Types of Services) of the Regulations for Implementing the Law of Medical Services; Second, to tryout the new system through pilot projects established in public hospitals and clinics; and third, to implement at all hospitals and equivalent medical institutions. In accordance with the plan, the Regulation has been amend and it was promulgated on January 9,1990, thus establishing a legal ground for implementing the policy. Subsequently, however, the Medical Association raised its objection to the policy, causing a delay in moving into the second stage of the plan. Under these circumstances, a study was conducted by collecting and evaluating the opinions of physicians, nurses, non-medical personnel and patients on the need and expected result from the home health care for the purpose of help facilitating the implementation of the new system. As a result of this study, it was revealed that: 1. Except the physicians, absolute majority of all other three groups - nurses, non-medical personnel and patients -gave positive answers to all 11 items related to the need for establishing a program for Home Health Care. Among the physicians, the opinions on the need for the new services were different depending on their field of specialty, and those who have been treating long term patients were more positive in supporting the new system. 2. The respondents in all four groups held very positive view for the effectiveness and the expected result of the program. The composite total of scores for all of 17 items, however, re-veals that the physicians were least positive for the- effectiveness of the new system. The people in all four groups held high expectation on the system on the ground that: it will help continued medical care after the discharge from hospitals; that it will alleviate physical and economic burden of patient's family; that it will offer nursing services at home for the patients who are suffering from chronic disease, for those early discharge from hospital, or those who are without family members to look after the patients at home. 3. Opinions were different between patients( who will receive services) and nurses (who will provide services) on the types of services home visiting nurses should offer. The patients wanted "education on how to take care patients at home", "making arrangement to be admitted into hospital when need arises", "IV injection", "checking blood pressure", and "administering medications." On the other hand, nurses believed that they can offer all 16 types of services except "Controlling pain of patients", 4. For the question of "what types of patients are suitable for Home Health Care Program; " the physicians, the nurses and non-medical personnel all gave high score on the cases of "patients of chronic disease", "patients of old age", "terminal cases", and the "patients who require long-term stay in hospital". 5. On the question of who should control Home Health Care Program, only physicians proposed that it should be done through hospitals, while remaining three groups recommended that it should be done through public institutions such as public health center. 6. On the question of home health care fee, the respondents in all four groups believed that the most desireable way is to charge a fixed amount of visiting fee plus treatment service fee and cost of material. 7. In the case when the Home Health Care Program is to be operated through hospitals, it is recommended that a new section be created in the out-patient department for an exclusive handling of the services, instead of assigning it to an existing section. 8. For the qualification of the nurses for-home visiting, the majority of respondents recommended that they should be "registered nurses who have had clinical experiences and who have attended training courses for home health care". 9. On the question of if the program should be implemented; 74.0% of physicians, 87.5% of non-medical personnel, and 93.0% of nurses surveyed expressed positive support. 10. Among the respondents, 74.5% of -physicians, 81.3% of non-medical personnel and 90.9% of nurses said that they would refer patients' to home health care. 11. To the question addressed to patients if they would take advantage of home health care; 82.7% said they would if the fee is applicable to the Health Insurance, and 86.9% said they would follow advises of physicians in case they were decided for early discharge from hospitals. 12. While 93.5% of nurses surveyed had heard about the Home Health Care Program, only 38.6% of physicians surveyed, 50.9% of non-medical personnel, and 35.7% of patients surveyed had heard about the program. In view of above findings, the following measures are deemed prerequisite for an effective implementation of Home Health Care Program. 1. The fee for home health care to be included in the public health insurance. 2. Clearly define the types and scope of services to be offered in the Home Health Care Program. 3. Develop special programs for training nurses who will be assigned to the Home Health Care Program. 4. Train those nurses by consigning them at hospitals and educational institutions. 5. Government conducts publicity campaign toward the public and the hospitals so that the hospitals support the program and patients take advantage of them. 6. Systematic and effective publicity and educational programs for home heath care must be developed and exercises for the people of medical professions in hospitals as well as patients and their families. 7. Establish and operate pilot projects for home health care, to evaluate and refine their programs.

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Roles of the Insulin-like Growth Factor System in the Reproductive Function;Uterine Connection (Insulin-like Growth Factor Systems의 생식기능에서의 역할;자궁편)

  • Lee, Chul-Young
    • Clinical and Experimental Reproductive Medicine
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    • v.23 no.3
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    • pp.247-268
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    • 1996
  • It has been known for a long time that gonadotropins and steroid hormones play a pivotal role in a series of reproductive biological phenomena including the maturation of ovarian follicles and oocytes, ovulation and implantation, maintenance of pregnancy and fetal growth & development, parturition and mammary development and lactation. Recent investigations, however, have elucidated that in addition to these classic hormones, multiple growth factors also are involved in these phenomena. Most growth factors in reproductive organs mediate the actions of gonadotropins and steroid hormones or synergize with them in an autocrine/paracrine manner. The insulin-like growth factor(IGF) system, which is one of the most actively investigated areas lately in the reproductive organs, has been found to have important roles in a wide gamut of reproductive phenomena. In the present communication, published literature pertaining to the intrauterine IGF system will be reviewed preceded by general information of the IGF system. The IGF family comprises of IGF-I & IGF-II ligands, two types of IGF receptors and six classes of IGF-binding proteins(IGFBPs) that are known to date. IGF-I and IGF-II peptides, which are structurally homologous to proinsulin, possess the insulin-like activity including the stimulatory effect of glucose and amino acid transport. Besides, IGFs as mitogens stimulate cell division, and also play a role in cellular differentiation and functions in a variety of cell lines. IGFs are expressed mainly in the liver and messenchymal cells, and act on almost all types of tissues in an autocrine/paracrine as well as endocrine mode. There are two types of IGF receptors. Type I IGF receptors, which are tyrosine kinase receptors having high-affinity for IGF-I and IGF-II, mediate almost all the IGF actions that are described above. Type II IGF receptors or IGF-II/mannose-6-phosphate receptors have two distinct binding sites; the IGF-II binding site exhibits a high affinity only for IGF-II. The principal role of the type II IGF receptor is to destroy IGF-II by targeting the ligand to the lysosome. IGFs in biological fluids are mostly bound to IGFBP. IGFBPs, in general, are IGF storage/carrier proteins or modulators of IGF actions; however, as for distinct roles for individual IGFBPs, only limited information is available. IGFBPs inhibit IGF actions under most in vitro situations, seemingly because affinities of IGFBPs for IGFs are greater than those of IGF receptors. How IGF is released from IGFBP to reach IGF receptors is not known; however, various IGFBP protease activities that are present in blood and interstitial fluids are believed to play an important role in the process of IGF release from the IGFBP. According to latest reports, there is evidence that under certain in vitro circumstances, IGFBP-1, -3, -5 have their own biological activities independent of the IGF. This may add another dimension of complexity of the already complicated IGF system. Messenger ribonucleic acids and proteins of the IGF family members are expressed in the uterine tissue and conceptus of the primates, rodents and farm animals to play important roles in growth and development of the uterus and fetus. Expression of the uterine IGF system is regulated by gonadal hormones and local regulatory substances with temporal and spatial specificities. Locally expressed IGFs and IGFBPs act on the uterine tissue in an autocrine/paracrine manner, or are secreted into the uterine lumen to participate in conceptus growth and development. Conceptus also expresses the IGF system beginning from the peri-implantation period. When an IGF family member is expressed in the conceptus, however, is determined by the presence or absence of maternally inherited mRNAs, genetic programming of the conceptus itself and an interaction with the maternal tissue. The site of IGF action also follows temporal (physiological status) and spatial specificities. These facts that expression of the IGF system is temporally and spatially regulated support indirectly a hypothesis that IGFs play a role in conceptus growth and development. Uterine and conceptus-derived IGFs stimulate cell division and differentiation, glucose and amino acid transport, general protein synthesis and the biosynthesis of mammotropic hormones including placental lactogen and prolactin, and also play a role in steroidogenesis. The suggested role for IGFs in conceptus growth and development has been proven by the result of IGF-I, IGF-II or IGF receptor gene disruption(targeting) of murine embryos by the homologous recombination technique. Mice carrying a null mutation for IGF-I and/or IGF-II or type I IGF receptor undergo delayed prenatal and postnatal growth and development with 30-60% normal weights at birth. Moreover, mice lacking the type I IGF receptor or IGF-I plus IGF-II die soon after birth. Intrauterine IGFBPs generally are believed to sequester IGF ligands within the uterus or to play a role of negative regulators of IGF actions by inhibiting IGF binding to cognate receptors. However, when it is taken into account that IGFBP-1 is expressed and secreted in primate uteri in amounts assessedly far exceeding those of local IGFs and that IGFBP-1 is one of the major secretory proteins of the primate decidua, the possibility that this IGFBP may have its own biological activity independent of IGF cannot be excluded. Evidently, elucidating the exact role of each IGFBP is an essential step into understanding the whole IGF system. As such, further research in this area is awaited with a lot of anticipation and attention.

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