• 의료법학
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• 제21권1호
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• pp.223-259
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• 2020

COVID-19가 순식간에 세계적으로 퍼져나가면서 이 바이러스에 대한 치료제 및 백신에 대한 연구 개발 이슈가 뜨겁다. 그 중에서도 렘데시비르(Remdesivir)가 가장 먼저 눈에 띄는 치료효과를 나타내며 본격적인 임상시험에 돌입하였고, 각 국가들은 긴급 승인을 통해 해당 의약품의 사용을 허가하고 있다. 그런데 렘데시비르의 개발사인 주식회사 길리어드는 렘데시비르를 희귀의약품으로 품목허가 신청하여 시민단체들로부터 많은 질타를 받았다. 그 이유는 희귀의약품으로 신약이 품목허가를 취득하는 경우 7년의 독점적 지위를 부여받을 수 있기 때문이다. 희귀의약품에게 장기간 동안 독점적 지위를 부여하는 것은 희귀질환으로 고생하는 환자들에게 치료기회를 부여하기 위해 제약회사에게 개발 동기를 부여하는 정책적 취지로부터 나온 것으로, 감염병 치료제에 적용하기에는 적절하지 않았기 때문이다. 본 논문은 이러한 정책적 의도를 바탕으로 의약품에 독점적 지위를 부여하고 있는 법령에 대하여 미국, 유럽, 일본을 상대로 비교법적 고찰을 통해 국내 제도의 문제점 및 개선 방향에 대해 살펴보는 내용을 담고 있다. 국내 제도는 독점적 지위 부여 방식에 있어 법령에 명시적인 조항을 두고 있지 않고, 재심사제도를 활용하여 우회적으로 독점적 지위를 부여하고 있다는 근본적인 문제를 갖고 있다. 이와 더불어 희귀의약품의 경우 「희귀질환관리법」과 「의약품의 품목허가·신고 심사 규정」에서 중복적으로 재심사기간을 규정하고 있다는 점, 상대적으로 독점기간을 길게 부여하고 있음에도 불구하고 사정변경 발생 시 독점적 지위를 회수할 수 있는 견제 조항이 존재하지 않는다는 점 등이 보완되어야 할 부분으로 보인다. 생물의약품의 경우에는 국내에는 우회적으로라도 의약품의 독점적 지위를 부여할 수 있는 규정이 존재하지 않는다. 생물의약품의 경우 특허를 받기 어렵다는 점에서, 독점권을 부여하는 것이 의약품 개발을 유도하는 큰 동기가 될 수 있음에도 이러한 조항이 없다는 점은 국내 법제의 아쉬운 점이라 볼 수 있다. 미국의 경우 최초의 동등생물의약품에도 1년의 독점기간을 부여한다는 점에 비추어 볼 때, 국내 법제는 생물의약품에 독점적 지위를 부여하는 것에 대하여 상당히 엄격하게 제한하고 있다고 해석된다. 이는 추후 국내 제약사의 생물의약품 개발 의지를 저하시킬 수 있다는 점에서, 또한 국제 규제의 조화를 맞출 필요가 있다는 점에서 국내 제도의 개선의 필요성이 인정된다 할 것이다. COVID-19의 발현을 기회로 삼아, 의약품에 독점권을 부여하고 있는 국내 제도가 가지고 있는 문제점에 대하여 다시 한 번 살펴보고, 통일된 법적 근거를 마련할 수 있도록 관련 법제에 대한 전반적인 개정이 이루어 질 것을 기대해보는 바이다.

• 한국보건간호학회지
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• 제37권2호
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• pp.247-260
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• 2023

Purpose: The purpose of this study was to gain an in-depth understanding of the characteristics and competencies of practice experienced by public health center nurses(PHNs) during the early response phase of the coronavirus disease 2019(COVID-19) pandemic. Methods: PHNs were recruited from public health centers(PHC) in ten cities in Korea, using purposive sampling. They participated in semi-structured, in-depth interviews from December 21, 2020, to February 18, 2021. The interviews were transcribed verbatim and analyzed using qualitative content analysis. Results: Three themes and nine categories were drawn from the findings. The three themes that emerged from the data analysis were as follows: 'Handling expanding work scope and overwhelming workload beyond prepared competencies, willing to go anywhere.', 'Performing tasks of cooperation and communication required in the disaster management administrative system.', 'Demonstrated proficiency in clinical nursing practices, but recognized the need for further development of leadership and administrative capabilities.' Conclusions: The experiences of the subjects' have implications for the development of content for community nursing education that cultivates basic competencies to respond to real pandemic situations during undergraduate education. It is proposed that it would be necessary to establish a support system for developing specialized competencies in public health nursing.

• Journal of Korean Neurosurgical Society
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• 제66권5호
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• pp.573-581
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• 2023

Objective : Due to the implementation of vaccinations and the development of therapeutic agents, the coronavirus disease 2019 (COVID-19) pandemic that started at the end of 2019 has entered a new phase. As a result, neurosurgeons should reconsider the way they treat their patients. As the COVID-19 situation prolongs, the change in neurosurgical emergency patients according to the number of confirmed cases is no longer clear. Outpatient treatment by telephone was permitted according to government policy. In addition, visits to caregivers in the intensive care unit were limited. Methods : The electronic medical records of patients who had been treated over the phone for a month (during April 2020, while the hospital was closing) were reviewed. Meanwhile, according to the limited visits to the intensive care unit, a video meeting was held with the caregivers. After the video meeting, satisfaction was evaluated using a questionnaire. Results : During April 2020, 1021 patients received non-face-to-face care over the telephone. Among the patients, no critical medical problem occurred due to non-face-to-face care. From July 2021 to December 2021, 321 patients were admitted to the neurosurgical intensive care unit and 107 patients (33.3%) including their caregivers agreed to video visits. Twice a week, advance notice was given that access would be made through a mobile device and the nurse explained to caregivers how to use the mobile device. The time for the video meeting was approximately 20 minutes per patient. Based on the questionnaire, 81 respondents (75.7%) answered that they agreed, and 26 respondents (24.3%) answered that they strongly agreed that was easy to communicate through video meetings. Fifty-two (48.6%) agreed and 55 (51.4%) strongly agreed that they were easy to understand the doctor's explanation. For overall satisfaction with this video meeting, three respondents (2.8%) gave 4/5 points and 95 respondents (88.8%) gave 5/5 points, and nine (8.4%) gave 3/5 points. Their reason was that there was not enough time. Conclusion : In situations where patient visits are limited, video meetings through a mobile device can provide sufficient satisfaction to caregivers. Telemedicine will likely become common in the near future. Health care professionals should prepare and respond to these needs and changes. Therefore, establishing a system with institutional support is necessary.

• 농촌의학ㆍ지역보건
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• 제47권2호
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• pp.61-66
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• 2022

Objectives: In the epidemiology of communicable diseases, the term epidemic period, also referred to as "wave" is often used in the general and academic milieu. A wave refers to a natural pattern of increase in the number of sick individuals, a defined peak, and then a decline in the number of cases. It implies a pattern of peaks and valleys after a particular peak is taken. The idea of epidemic waves is a useful tool for predicting the course as well as helping to accurately describe an epidemic. However, in many domestic and foreign news as well as in various research results in Korea, most of the reports either had no standard, were inaccurate, had a questionable classification of the period of the epidemic, or the basis for classification of a given wave was not presented. Methods: The author reviewed and organized related literature with epidemic wave. The author made several suggestions of an epidemic wave as follows. Results: To start with, it should be based on the number of incident cases in consideration of the size of the outbreak, then the period from the bottom to the peak and then reaching the next bottom; also, the period over a certain scale based on the number of incident cases; and the period according to the change in the major infection type (mutation-dominant species). In addition, according to the period of change in the vaccination rate (formation of herd immunity), as well as the content and duration of the intervention, that is, classification according to the applied quarantine stage. Furthermore, the classification of epidemic periods by the time-dependent reproduction number or time-varying reproduction number (Rt), and lastly the application of mathematical methodology. Conclusions: Therefore, classifying the epidemic period into generally known and accepted time frames is considered to be a very important task for future research analysis and development of intervention strategies.

• 대한의용생체공학회:의공학회지
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• 제44권6호
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• pp.363-376
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.

• 한국자원식물학회:학술대회논문집
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• 한국자원식물학회 2021년도 춘계학술대회
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• pp.3-3
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• 2021

The ongoing global pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has not only influenced over 1.26 billion people but also caused 2.77 million deaths worldwide (as of March 28, 2021). The vaccination could be the most efficient strategy to prevent SARS-CoV-2 infection. However, the continuous emergence of novel variants such as VUI-202012/01 (United Kingdom) and 501.V2 (South Africa) raises huge concerns about the effectiveness of the vaccine designed to target the original virus strain. Since ancient times regardless of the East and West, the plants which refered in this presentation have been consumed not only as food but also as a natural medicine to treat diverse diseases including infectious diseases. Importantly, these plants contain secondary metabolites that display antiviral activity involved in the inhibition of viral adsorption, penetration, and replication. Also, plant-derived natural medicines are expected to have a wider range of efficacy and fewer side effects than synthetic medicine, discovering novel plant-based viral agents would be a promising strategy to fight against SARS-CoV-2.

• Journal of Microbiology and Biotechnology
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• 제30권7호
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• pp.962-966
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• 2020

Monitoring the mutation dynamics of human severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is critical in understanding its infectivity, virulence and pathogenicity for development of a vaccine. In an "age of mobility," the pandemic highlights the importance and vulnerability of regionalization and labor market interdependence in Southeast Asia. We intend to characterize the genetic variability of viral populations within the region to provide preliminary information for regional surveillance in the future. By analyzing 142 complete genomes from South East Asian (SEA) countries, we identified three central variants distinguished by nucleotide and amino acid changes.

• IMMUNE NETWORK
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• 제23권4호
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• pp.33.1-33.13
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• 2023

Vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been acknowledged as an effective mean of preventing infection and hospitalization. However, the emergence of highly transmissible SARS-CoV-2 variants of concern (VOCs) has led to substantial increase in infections among children and adolescents. Vaccine-induced immunity and longevity have not been well defined in this population. Therefore, we aimed to analyze humoral and cellular immune responses against ancestral and SARS-CoV-2 variants after two shots of the BNT162b2 vaccine in healthy adolescents. Although vaccination induced a robust increase of spike-specific binding Abs and neutralizing Abs against the ancestral and SARS-CoV-2 variants, the neutralizing activity against the Omicron variant was significantly low. On the contrary, vaccine-induced memory CD4⁺ T cells exhibited substantial responses against both ancestral and Omicron spike proteins. Notably, CD4⁺ T cell responses against both ancestral and Omicron strains were preserved at 3 months after two shots of the BNT162b2 vaccine without waning. Polyfunctionality of vaccine-induced memory T cells was also preserved in response to Omicron spike protein. The present findings characterize the protective immunity of vaccination for adolescents in the era of continuous emergence of variants/subvariants.

• Tuberculosis and Respiratory Diseases
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• 제85권4호
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• pp.313-319
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• 2022

Environmental exposure to air pollution is known to have adverse effects on various organs. Air pollution has greater effects on the pulmonary system as the lungs are directly exposed to contaminants in the air. Here, we review the associations of air pollution with the development, morbidity, and mortality of pulmonary diseases. Short-and long-term exposure to air pollution have been shown to increase mortality risk even at concentrations below the current national guidelines. Ambient air pollution has been shown to be associated with lung cancer. Particularly long-term exposure to particulate matter with a diameter <2.5 ㎛ (PM_2.5) has been reported to be associated with lung cancer even at low concentrations. In addition, exposure to air pollution has been shown to increase the incidence risk of chronic obstructive pulmonary disease (COPD) and has been correlated with exacerbation and mortality of COPD. Air pollution has also been linked to exacerbation, mortality, and development of asthma. Exposure to nitrogen dioxide (NO₂) has been demonstrated to be related to increased mortality in patients with idiopathic pulmonary fibrosis. Additionally, air pollution increases the incidence of infectious diseases, such as pneumonia, bronchitis, and tuberculosis. Furthermore, emerging evidence supports a link between air pollution and coronavirus disease 2019 transmission, susceptibility, severity and mortality. In conclusion, the stringency of air quality guidelines should be increased and further therapeutic trials are required in patients at high risk of adverse health effects of air pollution.

• Journal of information and communication convergence engineering
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• 제20권1호
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• pp.31-40
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• 2022

Coronary heart disease (CHD) is a comorbidity of COVID-19; therefore, routine early diagnosis is crucial. A large number of examination attributes in the context of diagnosing CHD is a distinct obstacle during the pandemic when the number of health service users is significant. The development of a precise machine learning model for diagnosis with a minimum number of examination attributes can allow examinations and healthcare actions to be undertaken quickly. This study proposes a CHD diagnosis model based on feature selection, data balancing, and ensemble-based classification methods. In the feature selection stage, a hybrid SVM-GA combined with fast correlation-based filter (FCBF) is used. The proposed system achieved an accuracy of 94.60% and area under the curve (AUC) of 97.5% when tested on the z-Alizadeh Sani dataset and used only 8 of 54 inspection attributes. In terms of performance, the proposed model can be placed in the very good category.