• 제목/요약/키워드: Treatment principles

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Application of Molecular Diagnostics Technology in the Development of a Companion Diagnostics for Malignant Solid Tumors (악성 고형암의 항암제 동반진단 기술에서 분자진단기술의 적용)

  • Kim, Jin-Hee
    • The Journal of the Korea Contents Association
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    • v.19 no.3
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    • pp.365-374
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    • 2019
  • Unlike benign tumors, malignant tumors are capable of metastasis, easy to relapse, poor survival, and low quality of life. In Korea, here is a tendency to treat the tumors collectively according to the General Principles of Cancer Chemotherapy(GPCC) of the Health Insurance Review & Assessment Service (HIRA). But recently, companion diagnostics(CDx) is recommended rather than unilateral medication because biomarker-based molecular diagnostics is possible to predict the drug response of patients before drug treatment. Not only domestic but also overseas Food and Drug Administratio (FDA) recommends the development of the CDx system at the stage of drug development to ensure the responsiveness and safety of medicines. In this study, I focused on the necessity of CDx development direction as well as CDx development status through literature review. Furthermore I also discussed CDx types according to the molecular diagnostic technology such as immunohistochemistry (IHC), polymerase chain reaction (PCR), in situ hybridization (ISH), and next-generation sequencing (NGS) not only in the approved CDx but also in the developing one by US FDA. And I suggested the technology issue of CDx development process such as a selection of molecular diagnostics at the time of release, a clear understanding of the CDx mechanism, and a convergence of drug with CDx development. The necessity of social insurance system also was proposed for CDx development.

Susceptibility-Weighted Imaging as a Distinctive Imaging Technique for Providing Complementary Information for Precise Diagnosis of Neurologic Disorder (신경계 질환에 관한 정확한 진단을 위해 다양한 보완 정보를 제공하는 독특한 영상 기법으로서의 자기화율 강조 영상)

  • Byeong-Uk Jeon;In Kyu Yu;Tae Kun Kim;Ha Youn Kim;Seungbae Hwang
    • Journal of the Korean Society of Radiology
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    • v.82 no.1
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    • pp.99-115
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    • 2021
  • Various sequences have been developed for MRI to aid in the radiologic diagnosis. Among the various MR sequences, susceptibility-weighted imaging (SWI) is a high-spatial-resolution, three-dimensional gradient-echo MR sequence, which is very sensitive in detecting deoxyhemoglobin, ferritin, hemosiderin, and bone minerals through local magnetic field distortion. In this regard, SWI has been used for the diagnosis and treatment of various neurologic disorders, and the improved image quality has enabled to acquire more useful information for radiologists. Here, we explain the principle of various signals on SWI arising in neurological disorders and provide a retrospective review of many cases of clinically or pathologically proven disease or components with distinctive imaging features of various neurological diseases. Additionally, we outline a short and condensed overview of principles of SWI in relation to neurological disorders and describe various cases with characteristic imaging features on SWI. There are many different types diseases involving the brain parenchyma, and they have distinct SWI features. SWI is an effective imaging tool that provides complementary information for the diagnosis of various diseases.

Retrospect and Prospect of Medical Law 20th Anniversary (Medical Criminal Law) (의료법학 20주년 회고와 전망(의료형법 분야))

  • Ha, Tae Hoon
    • The Korean Society of Law and Medicine
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    • v.20 no.3
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    • pp.47-79
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    • 2019
  • The Korean Society of Law and Medicine has faithfully played the role of professional academic organizations last 20 years in terms of academic activities, accumulated achievements, diversity, professionalism, and influence on academic circles. The Korean Society of Law and Medicine and the Journal of Medical Law serve as a platform for academic information and exchange of opinions on medical law. Medical law began in the midst of increasing conflicts and disputes caused by medical malpractice and the enactment and legal coercion of medical care as pressure on medical workers. It tried to find a way to coexist with each other through the encounter and convergence of medicine and law. Medical criminal law extends from traditional crimes in the realm of life and body protection to bioethics violations caused by the development of biomedical technology, corruption and economic crime in the medical field. Medical law has evolved into a comprehensive legal area dealing with legal issues raised in medical treatment, healthcare, bioethics, and life sciences technology. On the legal side, medical law is not independent legal areas. It is overlapping with traditional law areas such as civil law, administrative law, criminal law, social law, civil and criminal procedure law. However, it is now established as a convergence study in medicine, bioethics, life science, as well as in various fields of law. It has become an area where collaboration is needed with the field of law, medicine, ethics, sociology and economics. Medical criminal law has undergone a dynamic development over the last two decades. The development of medicine and medical technology provides new and innovative methods of diagnosis and treatment. The achievements and risks of revolutionary developments in biotechnology, genetic engineering and medicine coexist. While there is a dazzling achievement that mankind has hoped for: combating disease and improving health, it also creates unwanted side effects and risks to humans. There is a need to reconsider ethical and legal principles. The discovery and development of patient identity and autonomy has changed the medical doctor-patient relationship. Furthermore, it was complicated by the triangle relationship of patients, medical doctors and insurance. Legal matters are also complicated. This is why the necessity of legislation is emerging. Criminal punishment provisions are also required. The Medical Law and Biomedical Law are systematically and coherently deformed as mosaic-based legislation that takes place whenever there are social issues, citizens' needs, and medical organizations' interests, rather than sufficient enactment and revision procedures. It needs a complete overhaul, and this is possible through interdisciplinary collaboration which is the strength of The Korean Society of Law and Medicine.

Prevalence of Intimal Defect in the Patients urith Surgically Treated Acute Type A Intramural Hematoma of the Aorta (외과적으로 치료한 급성 A형 대동맥벽내 혈종 환자에서 대동맥 내막 결손의 존재 빈도)

  • Park, Kay-Hyun
    • Journal of Chest Surgery
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    • v.40 no.11
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    • pp.733-744
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    • 2007
  • Background: There is a controversy regarding the pathogenesis and management principle of an acute intramural hematoma (IMH) of the aorta, Recent studies have reported intimal defects in many patients diagnosed with IMH, and suggested that intimal defects play important roles in the pathogenesis, progression of the pathology, and prognosis. Material and Method: This study reviewed the preoperative and postoperative computed tomography (CT) scan images of 36 patients who underwent surgical treatment for Stanford type A acute IMH of the aorta. The surgical findings were also reviewed retrospectively from the medical records. Result: In 15 patients (41.7%), the findings suggestive of the intimal defects were found in the preoperative CT. During the operation, 20 patients (72.2%) were found to have small intimal defects in the ascending aorta or the arch, of which 13 patients (50.5%) did not have the CT findings suggestive of intimal defects. In 17 patients, the intimal defects were located in the aortic arch or distal ascending aorta, where a gross examination would have been impossible without total circulatory arrest. In all patients, the intimal defects identified were included in the resected aortic segment, or locally closed. Follow-up CT at 4 months or longer after surgery showed that the IMH in the descending aorta had disappeared or was markedly improved. Conclusion: Most patients undergoing surgical treatment for acute type A IMH had intimal defects. This suggests that a large proportion of IMH might have a similar pathogenic mechanism as classic dissection. Consequently, it is believed that those two entities of acute aortic syndrome should be treat-ed using the same principles.

Lecompte Procedure in Complex Congenital Heart Diseases (선천성 복잡 심기형에서의 Lecompte 술식의 유용성 및 임상적용에 관한 연구)

  • Kim, Yong-Jin;Kim, Kyung-Hwan;Lee, Suk-Jae;Song, Hyun;Oh, Sam-Se;Lee, Jeong-Ryul;Rho, Joon-Ryang;Suh, Kyung-Phill
    • Journal of Chest Surgery
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    • v.31 no.7
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    • pp.660-667
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    • 1998
  • Background: This study is to evaluate the effectiveness and application of Lecompte procedure as a treatment for various complex cardiac anomalies with pulmonary outflow tract obstruction. Methods: Between July 1988 and December 1997, 44 patients underwent Lecompte procedure in Seoul National University Children's Hospital. The male to female ratio was 24 to 20 and the mean age was 29.2 months(range, 3 to 83). Of these patients, 28(63.6%) had transposition of great arteries with ventricular septal defect and pulmonary stenosis(or pulmonary atresia), 14(31.8%) had double outlet right ventricle with pulmonary stenosis(or pulmonary atresia), and so on. The principles of the technique are 1) extension of the ventricular septal defect or conal resection, 2) construction of a intracardiac tunnel connecting the left ventricle to the aorta, and 3) direct connection, without a prosthetic conduit, of the pulmonary trunk to the right ventricle. Results: There were 3 in-hospital deaths and their causes were sustained hypoxia, myocardial failure, and sepsis, respectively. There was 1 late death due to sepsis. Reoperations were performed in 6 patients who had pulmonary outflow tract obstructions(4 cases), residual muscular ventricular septal defect(1 case), and recurrent septic vegetation(1 case). The cumulative survival rates by the Kaplan-Meier method were 92.7%, 92.7%, and 92.7% at 1, 2, and over 4 years. The reoperation free survival rates were 92.7%, 92.7%, and 70.2% at 1, 3, and over 5 years. Among the risk factors for the operative death, aortic cross clamping time had statistical significance(p<0.05) and all the risk factors for the recurrent pulmonary stenosis such as age, pulmonary artery index, and materials used for the pulmonary outflow tract reconstruction had no statistical significance(p>0.05). Conclusions: Our review suggests that Lecompte procedure is an effective treatment modality for various complex cardiac anomalies with pulmonary outflow tract obstruction. Repair in early age is possible and the rates of mortality and morbidity are also acceptable.

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An Analysis of Swimming Injuries and Their Rehabilitation (근육 골격계의 질환 및 재활분석(수영선수를 중심으로))

  • Kim, Kwi-Baek;Ji, Jin-Gu;Kwak, Yi-Sub
    • Journal of Life Science
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    • v.32 no.4
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    • pp.325-330
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    • 2022
  • While swimming is a very popular competitive sports activity, swimming injuries are unique due to the repetitive nature of the swimming stroke and demanding training programs that can result in upper limb overuse. Therefore, the primary objective of this review was to analyze swimmers' injury areas, injury types by stroke type, and swimming rehabilitation, as well as to discuss safety management for improving swimming performance. In this study, the injuries incurred in swimming events were discussed in the order of upper limb injuries (neck, shoulder, arm, and wrist), lower limb injuries (knee and ankle), and waist injuries. An analysis by stroke type found that shoulder injuries occurred most often with freestyle, backstroke, and butterfly strokes, followed by rotator cuff injury, impingement syndrome, and SLAP (superior labral tear from anterior to posterior) lesions. Knee injuries were associated with the breaststroke, whereas spinal cord injuries occurred with the breaststroke and butterfly stroke. Finally, back injuries were associated with the butterfly stroke. During the freestyle stroke, the shoulder undergoes repetitive overhead movement; hence, shoulder and musculoskeletal pain are the most common and well-documented complaints of swimmers. For safety management, coaches and instructors must ensure that athletes do sufficient warm-up and cool-down exercises to avoid injuries. In case of an injury, they should be familiar with first aid measures so that secondary damage can be prevented with its quick application. In addition, coaches and instructors need to be trained in injury prevention and treatment so that they can provide appropriate rehabilitation treatment for athletes. Although swimming-related injuries cannot be completely eliminated, to reduce them to a minimum, leaders need the knowledge to apply scientific and systematic training principles and methods individualized for each athlete.

The recent essay of Bijeung - Study of III- (비증(痺證)에 대(對)한 최근(最近)의 제가학설(諸家學說) 연구(硏究) - 《비증전집(痺證專輯)》 에 대(對)한 연구(硏究) III -)

  • Yang, Tae-Hoon;Oh, Min-Suk
    • Journal of Haehwa Medicine
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    • v.9 no.1
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    • pp.513-545
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    • 2000
  • I. Introduction Bi(痺) means blocking. It can reach at the joints or muscles or whole body and make pains. Numbness and movement disorders. BiJeung can be devided into SilBi and HeoBi. In SilBi there are PungHanSeupBi, YeolBi and WanBi. In HeoBi, there are GiHyeolHeoBi, EumHeoBi and YangHeoBi. The common principle for the treatment of BiJeung is devision of the chronic stage and the acute stage. In the acute stage, BiJeung is usually cured easily but in the chronic stage, it is difficult. In the terminal stage, BiJeung can reach at the internal organs. BiJeung is one kind of symptoms making muscles, bones and jonts feel pain, numbness or edema. For example it can be gout or SLE etc. Many famous doctors studied medical science by their fathers or teachers. So the history of medical science is long. So I studied ${\ll}Bijeungjujip{\gg}$. II. Final Decision 1. BanSuMun(斑秀文) thought that BiJeung can be cured by blocking of blood stream. So he insisted that the important thing to cure BiJeung is to improve the blood stream. He usually used DangGuiSaYeokTang(當歸四逆湯), DangGuiJakYakSanHapORyeongSan, DoHong-SaMulTang(桃紅四物湯), SaMyoSanHapHeuiDongTang and HwangGiGyeJiOMulTang. 2. JangGeonBu(張健夫) focused on soothing muscles and improving blood seam. So he used many herbs like WiRyeongSeon(威靈仙), GangHwal(羌活), DokHwal(獨活), WooSeul(牛膝), etc. Especially he pasted wastes of the boiled herbs. 3. OSeongNong(吳聖農) introduced four rules to treat arthritis. So he usually used SeoGak-SanGaGam(犀角散加減), BoYanHwanOTang(補陽還五湯), ODuTang(烏頭湯), HwangGiGyeJiOMulTang. 4. GongJiSin thought disk hernia as one kind of BiJeung. And he said that Pung can hurt upper limbs and Seup can hurt lower limbs. He used to use GyeJiJakYakJiMoTang(桂枝芍藥知母湯). 5. LoJiJeong(路志正) introduced four principles to treat BiJeung. He used BangPungTang(防風湯), DaeJinGuTang) for PungBi(風痺), OPaeTang(烏貝湯) for HanBi(寒痺), YukGunJaTang(六君子湯) for SeupBi(濕痺) and SaMyoTang(四妙湯), SeonBiTang(宣痺湯), BaekHoGaGyeTang(白虎加桂湯) for YeolBi(熱痺). 6. GangChunHwa(姜春華) discussed herbs. He said SaengJiHwang(生地黃) is effective for PungSeupBi and WiRyungSun(威靈仙) is effective for the joints pain. He usually used SipJeonDaeBoTang(十全大補湯), DangGuiDaeBoTang(當歸大補湯), YoukGunJaTang(六君子湯) and YukMiJiHwanTang(六味地黃湯). 7. DongGeonHwa(董建華) said that the most important thing to treat BiJeung is how to use herbs. He usually used CheonO(川烏), MaHwang(麻黃) for HanBi, SeoGak(犀角) for YeolBi, BiHae) or JamSa(蠶沙) for SeupBi, SukJiHwang(熟地黃) or Vertebrae of Pigs for improving the function of kidney and liver, deer horn or DuChung(杜沖) for improving strength of body and HwangGi(黃?) or OGaPi(五加皮) for improving the function of heart. 8. YiSuSan(李壽山) devided BiJeung into two types(PungHanSeupBi, PungYeolSeupBi). And he used GyeJiJakYakJiMoTang(桂枝芍藥知母湯) for the treatment of gout. And he liked to use HwanGiGyeJiOMulTangHapSinGiHwan 枝五物湯合腎氣丸) for the treat ment of WanBi(頑痺). 9. AnDukHyeong(顔德馨) made YongMaJeongTongDan(龍馬定痛丹)-(MaJeonJa(馬錢子) 30g, JiJaChung 3g, JiRyong(地龍) 3g, JeonGal(全蝎) 3g, JuSa(朱砂) 0.3g) 10. JangBaekYou(張伯臾) devided BiJeung into YeolBi and HanBi. And he focused on improving blood stream. 11. JinMuO(陳茂梧) introduced anti-wind and dampness prescription(HoJangGeun(虎杖根) 15g, CheonChoGeun 15g, SangGiSaeng(桑寄生) 15g, JamSa(蠶絲) 15g, JeMaJeonJa(制馬錢子) 3g). 12. YiChongBo(李總甫) explained basic prescriptions to treat BiJeung. He used SinJeongChuBiEum(新定推痺陰) for HaengBi(行痺), SinJeongHwaBiSan(新定化痺散) for TongBi(痛痺), SinJeongGaeBiTang(新定開痺湯) for ChakBi(着痺), SinJeongCheongBiEum(新定淸痺飮) for SeupYeolBi(濕熱痺), SinRyeokTang(腎瀝湯) for PoBi(胞痺), ORyeongSan for BuBi(腑痺), OBiTang(五痺湯) for JangBi(臟痺), SinChakTang(腎着湯) for SingChakByeong(腎着病). 13. HwangJeonGeuk(黃傳克) used SaMu1SaDeungHapJe(四物四藤合制) for the treatment of a acute arthritis, PalJinHpPalDeungTang(八珍合八藤湯) or BuGyeJiHwangTangHapTaDeungTang(附桂地黃湯合四藤湯) for the chronic stage and ByeolGapJeungAekTongRakEum(鱉甲增液通絡飮) for EumHeo(陰虛) 14. GaYeo(柯與參) used HwalRakJiTongTang(活絡止痛湯) for shoulder ache, SoJongJinTongHwalRakTank(消腫鎭痛活絡湯) for YeolBi(熱痺), LiGwanJeolTang(利關節湯) for ChakBi(着痺), SinBiTang(腎痺湯) for SinBi(腎痺) and SamGyoBoSinHwan(三膠補腎丸) for back ache. 15. JangGilJin(蔣길塵) liked to use hot-character herbs and insects. And he used SeoGeunLipAnTang(舒筋立安湯) as basic prescription. 16. RyuJangGeol(留章杰) used GuMiGangHwalTang(九味羌活湯) and BangPungTang(防風湯) at the acute stage, ODuTang(烏頭湯) or GyeJiJakYakJiMoTang(桂枝芍藥知母湯) for HanBi of internal organs, YangHwaHaeEungTang(陽和解凝湯) for HanBi, DokHwalGiSaengTang(獨活寄生湯), EuiYiInTang(薏苡仁湯) for SeupBi, YukGunJaTang(六君子湯) for GiHeoBi(氣虛痺) and SeongYouTang(聖兪湯) for HyeolHeoBi(血虛痺). 17. YangYuHak(楊有鶴) liked to use SoGyeongHwalHyelTang(疏經活血湯) and he would rather use DoIn(桃仁), HongHwa(紅花), DangGui(當歸), CheonGung(川芎) than insects. 18. SaHongDo(史鴻濤) made RyuPungSeupTang(類風濕湯)-((HwangGi 200g, JinGu 20g, BangGi(防己) 15g, HongHwa(紅花) 15g, DoIn(桃仁) 15g, CheongPungDeung(靑風藤) 20g, JiRyong(地龍) 15g, GyeJi(桂枝) 15g, WoSeul(牛膝) 15g, CheonSanGap(穿山甲) 15g, BaekJi(白芷) 15g, BaekSeonPi(白鮮皮) 15g, GamCho(甘草) 15g).

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Application and Expansion of the Harm Principle to the Restrictions of Liberty in the COVID-19 Public Health Crisis: Focusing on the Revised Bill of the March 2020 「Infectious Disease Control and Prevention Act」 (코로나19 공중보건 위기 상황에서의 자유권 제한에 대한 '해악의 원리'의 적용과 확장 - 2020년 3월 개정 「감염병의 예방 및 관리에 관한 법률」을 중심으로 -)

  • You, Kihoon;Kim, Dokyun;Kim, Ock-Joo
    • The Korean Society of Law and Medicine
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    • v.21 no.2
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    • pp.105-162
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    • 2020
  • In the pandemic of infectious disease, restrictions of individual liberty have been justified in the name of public health and public interest. In March 2020, the National Assembly of the Republic of Korea passed the revised bill of the 「Infectious Disease Control and Prevention Act.」 The revised bill newly established the legal basis for forced testing and disclosure of the information of confirmed cases, and also raised the penalties for violation of self-isolation and treatment refusal. This paper examines whether and how these individual liberty limiting clauses be justified, and if so on what ethical and philosophical grounds. The authors propose the theories of the philosophy of law related to the justifiability of liberty-limiting measures by the state and conceptualized the dual-aspect of applying the liberty-limiting principle to the infected patient. In COVID-19 pandemic crisis, the infected person became the 'Patient as Victim and Vector (PVV)' that posits itself on the overlapping area of 'harm to self' and 'harm to others.' In order to apply the liberty-limiting principle proposed by Joel Feinberg to a pandemic with uncertainties, it is necessary to extend the harm principle from 'harm' to 'risk'. Under the crisis with many uncertainties like COVID-19 pandemic, this shift from 'harm' to 'risk' justifies the state's preemptive limitation on individual liberty based on the precautionary principle. This, at the same time, raises concerns of overcriminalization, i.e., too much limitation of individual liberty without sufficient grounds. In this article, we aim to propose principles regarding how to balance between the precautionary principle for preemptive restrictions of liberty and the concerns of overcriminalization. Public health crisis such as the COVID-19 pandemic requires a population approach where the 'population' rather than an 'individual' works as a unit of analysis. We propose the second expansion of the harm principle to be applied to 'population' in order to deal with the public interest and public health. The new concept 'risk to population,' derived from the two arguments stated above, should be introduced to explain the public health crisis like COVID-19 pandemic. We theorize 'the extended harm principle' to include the 'risk to population' as a third liberty-limiting principle following 'harm to others' and 'harm to self.' Lastly, we examine whether the restriction of liberty of the revised 「Infectious Disease Control and Prevention Act」 can be justified under the extended harm principle. First, we conclude that forced isolation of the infected patient could be justified in a pandemic situation by satisfying the 'risk to the population.' Secondly, the forced examination of COVID-19 does not violate the extended harm principle either, based on the high infectivity of asymptomatic infected people to others. Thirdly, however, the provision of forced treatment can not be justified, not only under the traditional harm principle but also under the extended harm principle. Therefore it is necessary to include additional clauses in the provision in order to justify the punishment of treatment refusal even in a pandemic.

Analysis of HBeAg and HBV DNA Detection in Hepatitis B Patients Treated with Antiviral Therapy (항 바이러스 치료중인 B형 간염환자에서 HBeAg 및 HBV DNA 검출에 관한 분석)

  • Cheon, Jun Hong;Chae, Hong Ju;Park, Mi Sun;Lim, Soo Yeon;Yoo, Seon Hee;Lee, Sun Ho
    • The Korean Journal of Nuclear Medicine Technology
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    • v.23 no.1
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    • pp.35-39
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    • 2019
  • Purpose Hepatitis B virus (hepatitis B virus, HBV) infection is a worldwide major public health problem and it is known as a major cause of chronic hepatitis, liver cirrhosis and liver cancer. And serologic tests of hepatitis B virus is essential for diagnosing and treating these diseases. In addition, with the development of molecular diagnostics, the detection of HBV DNA in serum diagnoses HBV infection and is recognized as an important indicator for the antiviral agent treatment response assessment. We performed HBeAg assay using Immunoradiometric assay (IRMA) and Chemiluminescent Microparticle Immunoassay (CMIA) in hepatitis B patients treated with antiviral agents. The detection rate of HBV DNA in serum was measured and compared by RT-PCR (Real Time - Polymerase Chain Reaction) method Materials and Methods HBeAg serum examination and HBV DNA quantification test were conducted on 270 hepatitis B patients undergoing anti-virus treatment after diagnosis of hepatitis B virus infection. Two serologic tests (IRMA, CMIA) with different detection principles were applied for the HBeAg serum test. Serum HBV DNA was quantitatively measured by real-time polymerase chain reaction (RT-PCR) using the Abbott m2000 System. Results The detection rate of HBeAg was 24.1% (65/270) for IRMA and 82.2% (222/270) for CMIA. Detection rate of serum HBV DNA by real-time RT-PCR is 29.3% (79/270). The measured amount of serum HBV DNA concentration is $4.8{\times}10^7{\pm}1.9{\times}10^8IU/mL$($mean{\pm}SD$). The minimum value is 16IU/mL, the maximum value is $1.0{\times}10^9IU/mL$, and the reference value for quantitative detection limit is 15IU/mL. The detection rates and concentrations of HBV DNA by group according to the results of HBeAg serological (IRMA, CMIA)tests were as follows. 1) Group I (IRMA negative, CMIA positive, N = 169), HBV DNA detection rate of 17.7% (30/169), $6.8{\times}10^5{\pm}1.9{\times}10^6IU/mL$ 2) Group II (IRMA positive, CMIA positive, N = 53), HBV DNA detection rate 62.3% (33/53), $1.1{\times}10^8{\pm}2.8{\times}10^8IU/mL$ 3) Group III (IRMA negative, CMIA negative, N = 36), HBV DNA detection rate 36.1% (13/36), $3.0{\times}10^5{\pm}1.1{\times}10^6IU/mL$ 4) Group IV(IRMA positive, CMIA negative, N = 12), HBV DNA detection rate 25% (3/12), $1.3{\times}10^3{\pm}1.1{\times}10^3IU/mL$ Conclusion HBeAg detection rate according to the serological test showed a large difference. This difference is considered for a number of reasons such as characteristics of the Ab used for assay kit and epitope, HBV of genotype. Detection rate and the concentration of the group-specific HBV DNA classified serologic results confirmed the high detection rate and the concentration in Group II (IRMA-positive, CMIA positive, N = 53).

Legal Issues on the Collection and Utilization of Infectious Disease Data in the Infectious Disease Crisis (감염병 위기 상황에서 감염병 데이터의 수집 및 활용에 관한 법적 쟁점 -미국 감염병 데이터 수집 및 활용 절차를 참조 사례로 하여-)

  • Kim, Jae Sun
    • The Korean Society of Law and Medicine
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    • v.23 no.4
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    • pp.29-74
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    • 2022
  • As social disasters occur under the Disaster Management Act, which can damage the people's "life, body, and property" due to the rapid spread and spread of unexpected COVID-19 infectious diseases in 2020, information collected through inspection and reporting of infectious disease pathogens (Article 11), epidemiological investigation (Article 18), epidemiological investigation for vaccination (Article 29), artificial technology, and prevention policy Decision), (3) It was used as an important basis for decision-making in the context of an infectious disease crisis, such as promoting vaccination and understanding the current status of damage. In addition, medical policy decisions using infectious disease data contribute to quarantine policy decisions, information provision, drug development, and research technology development, and interest in the legal scope and limitations of using infectious disease data has increased worldwide. The use of infectious disease data can be classified for the purpose of spreading and blocking infectious diseases, prevention, management, and treatment of infectious diseases, and the use of information will be more widely made in the context of an infectious disease crisis. In particular, as the serious stage of the Disaster Management Act continues, the processing of personal identification information and sensitive information becomes an important issue. Information on "medical records, vaccination drugs, vaccination, underlying diseases, health rankings, long-term care recognition grades, pregnancy, etc." needs to be interpreted. In the case of "prevention, management, and treatment of infectious diseases", it is difficult to clearly define the concept of medical practicesThe types of actions are judged based on "legislative purposes, academic principles, expertise, and social norms," but the balance of legal interests should be based on the need for data use in quarantine policies and urgent judgment in public health crises. Specifically, the speed and degree of transmission of infectious diseases in a crisis, whether the purpose can be achieved without processing sensitive information, whether it unfairly violates the interests of third parties or information subjects, and the effectiveness of introducing quarantine policies through processing sensitive information can be used as major evaluation factors. On the other hand, the collection, provision, and use of infectious disease data for research purposes will be used through pseudonym processing under the Personal Information Protection Act, consent under the Bioethics Act and deliberation by the Institutional Bioethics Committee, and data provision deliberation committee. Therefore, the use of research purposes is recognized as long as procedural validity is secured as it is reviewed by the pseudonym processing and data review committee, the consent of the information subject, and the institutional bioethics review committee. However, the burden on research managers should be reduced by clarifying the pseudonymization or anonymization procedures, the introduction or consent procedures of the comprehensive consent system and the opt-out system should be clearly prepared, and the procedure for re-identifying or securing security that may arise from technological development should be clearly defined.