首页 > 最新文献

Медицинская этика最新文献

英文 中文
Connecting links of history. Yaroslavl and Sergey Spasokukotsky 连接历史的纽带雅罗斯拉夫尔和谢尔盖-斯帕索库茨基
Pub Date : 2024-03-01 DOI: 10.24075/medet.2024.004
NT Eregina
Biography of Sergey Spasokukotsky, the outstanding Russian surgeon, is closely related to the Yaroslavl Territory. He spent his childhood in the Danilovsky region, coming from a large and friendly family of a zemstvo doctor. In 1880–1888, he studied at the Men’s Gymnasium after his family had moved to Yaroslavl. The building now belongs to the Yaroslavl State Medical University where a representative of his scientific school, Professor Busalov AA, worked decades later. Life and activity of Sergey Spasokukotsky represent a bright example of unselfish service to medicine. Being a graduate of the Emperor’s Moscow University, he had a chance to continue his medical career in Moscow but went to the province where he worked as a zemstvo doctor for many years, actively implementing advance achievements of medicine into abdominal surgery, neurosurgery, pulmonary surgery, creating novel and modifying available surgeries. S. Spasokukotsky and his student developed an affordable and effective method of preparing a surgeon’s hands for a surgery with 0.5% ammonia solution (method by Spasokukotsky and Kochergyn). The scientific and practical activities of Sergey Spasokukotsky resulted in the development of a large scientific school with an ultimate scientific social responsibility, originality, great depth and boldness while solving the issues of surgical pathology.
俄罗斯杰出外科医生谢尔盖-斯帕索库茨基的生平与雅罗斯拉夫尔边疆区密切相关。他的童年是在丹尼洛夫斯基地区度过的,出身于一个和蔼可亲的医生大家庭。1880-1888 年,他举家迁往雅罗斯拉夫尔后在男子体育馆学习。这座建筑现在属于雅罗斯拉夫尔国立医科大学,几十年后,他的科学流派代表布萨罗夫-AA教授曾在这里工作。谢尔盖-斯帕索库茨基的生活和活动是为医学无私奉献的光辉典范。谢尔盖-斯帕索库茨基毕业于莫斯科帝国大学,本有机会在莫斯科继续他的医学生涯,但他还是去了外省,在那里担任了多年的zemstvo医生,积极将医学的先进成果应用于腹部外科、神经外科、肺部外科,创造了新的手术方法并对现有的手术方法进行了修改。谢尔盖-斯帕索库茨基和他的学生发明了一种既经济又有效的方法,用 0.5% 的氨溶液(斯帕索库茨基和科切尔金的方法)为外科医生的双手做好手术前的准备。谢尔盖-斯帕索库茨基的科学实践活动导致了一个大型科学流派的发展,该流派在解决外科病理学问题时具有终极的科学社会责任感、独创性、巨大的深度和胆识。
{"title":"Connecting links of history. Yaroslavl and Sergey Spasokukotsky","authors":"NT Eregina","doi":"10.24075/medet.2024.004","DOIUrl":"https://doi.org/10.24075/medet.2024.004","url":null,"abstract":"Biography of Sergey Spasokukotsky, the outstanding Russian surgeon, is closely related to the Yaroslavl Territory. He spent his childhood in the Danilovsky region, coming from a large and friendly family of a zemstvo doctor. In 1880–1888, he studied at the Men’s Gymnasium after his family had moved to Yaroslavl. The building now belongs to the Yaroslavl State Medical University where a representative of his scientific school, Professor Busalov AA, worked decades later. Life and activity of Sergey Spasokukotsky represent a bright example of unselfish service to medicine. Being a graduate of the Emperor’s Moscow University, he had a chance to continue his medical career in Moscow but went to the province where he worked as a zemstvo doctor for many years, actively implementing advance achievements of medicine into abdominal surgery, neurosurgery, pulmonary surgery, creating novel and modifying available surgeries. S. Spasokukotsky and his student developed an affordable and effective method of preparing a surgeon’s hands for a surgery with 0.5% ammonia solution (method by Spasokukotsky and Kochergyn). The scientific and practical activities of Sergey Spasokukotsky resulted in the development of a large scientific school with an ultimate scientific social responsibility, originality, great depth and boldness while solving the issues of surgical pathology.","PeriodicalId":507498,"journal":{"name":"Медицинская этика","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140401929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bioethical approach to estimation of pharmacoepidemiological and pharmacoeconomic aspects of psoriasis treatment 从生物伦理角度估算银屑病治疗的药物流行病学和药物经济学问题
Pub Date : 2024-03-01 DOI: 10.24075/medet.2024.001
EI Samarina, EG Lileeva, JV Rybachkova
Bioethical approach to determine the feasibility of using medicines involves systemic analysis of pharmacoepidemiological and pharmacoeconomic aspects of treatment, especially while treating the most common and chronic diseases. Psoriasis is the most common disease of the skin and subcutaneous tissue, accounting for 15% of cases. The rate of psoriatic complications constitutes 6–42%. Skin lesions, psoriatic arthritis, cardiovascular diseases, metabolic syndrome, inflammatory intestinal diseases, mental disorders and malignant lesions produce a great effect on health, duration and quality of life, and result in early loss of labor capacity and disability of patients. So, it is important to study effectiveness and safety of systemic medicines in patients with severe and moderate-to-severe disease and perform subsequent analysis of possible use and comparison of the effectiveness of various combinations. Most affordable but ineffective medicines commonly cause real growth of further expenses on treatment, and postpone administration of more effective, though much more expensive medicines. Economic aspects of rational use of healthcare resources are becoming increasingly important whereas pharmacoeconomic values are crucial while selecting a treatment strategy.
确定药物使用可行性的生物伦理方法包括对治疗的药物流行病学和药物经济学方面进行系统分析,尤其是在治疗最常见的慢性疾病时。银屑病是皮肤和皮下组织最常见的疾病,占病例总数的 15%。银屑病并发症的发生率为 6-42%。皮损、银屑病关节炎、心血管疾病、代谢综合征、炎症性肠道疾病、精神障碍和恶性病变对患者的健康、寿命和生活质量产生巨大影响,并导致患者早期丧失劳动能力和残疾。因此,必须研究重症和中重度疾病患者使用全身用药的有效性和安全性,并对可能使用的药物进行后续分析,比较各种联合用药的效果。大多数价格低廉但疗效不佳的药物通常会导致进一步治疗费用的实际增长,并推迟使用更有效但价格昂贵得多的药物。合理使用医疗资源的经济因素正变得越来越重要,而药物经济学价值则是选择治疗策略的关键。
{"title":"Bioethical approach to estimation of pharmacoepidemiological and pharmacoeconomic aspects of psoriasis treatment","authors":"EI Samarina, EG Lileeva, JV Rybachkova","doi":"10.24075/medet.2024.001","DOIUrl":"https://doi.org/10.24075/medet.2024.001","url":null,"abstract":"Bioethical approach to determine the feasibility of using medicines involves systemic analysis of pharmacoepidemiological and pharmacoeconomic aspects of treatment, especially while treating the most common and chronic diseases. Psoriasis is the most common disease of the skin and subcutaneous tissue, accounting for 15% of cases. The rate of psoriatic complications constitutes 6–42%. Skin lesions, psoriatic arthritis, cardiovascular diseases, metabolic syndrome, inflammatory intestinal diseases, mental disorders and malignant lesions produce a great effect on health, duration and quality of life, and result in early loss of labor capacity and disability of patients. So, it is important to study effectiveness and safety of systemic medicines in patients with severe and moderate-to-severe disease and perform subsequent analysis of possible use and comparison of the effectiveness of various combinations. Most affordable but ineffective medicines commonly cause real growth of further expenses on treatment, and postpone administration of more effective, though much more expensive medicines. Economic aspects of rational use of healthcare resources are becoming increasingly important whereas pharmacoeconomic values are crucial while selecting a treatment strategy.","PeriodicalId":507498,"journal":{"name":"Медицинская этика","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140269288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
School of research ethics. Axiology of bioethics and challenges of technological development 研究伦理学院。生物伦理公理与技术发展的挑战
Pub Date : 2024-03-01 DOI: 10.24075/medet.2023.035
DE Firsov
Intensive development of modern science expands the scope of bioethical issues. Debates on ethical aspects of bioinformatics, neurotechnology, genetics, bioeconomics, ethics of preclinical and clinical trials are actively developing. Axiology of bioethics is of particular relevance. It is the structure of valuable categories that determines the priorities of ‘human science’ development taking into account the historical experience of interaction between a person and community, and criteria of civilized changes in the actual and perspective (prognostic) sense. Development of bioethical axiology is influenced by the challenges of technological development of the current decade, the issues that objectively demand a reaction on the part of the state and society. One of the main tasks of modern bioethics is to develop bioethical thinking, and grounds for using bioethical axiology in the scientific process. Health axiology, which represents a fixed conscious attitude to the issues of health developed during the academic process to be subsequently used during a labor process, is practical expression of bioethical thinking. Bioethical dialogue is essential as it urges young perspective specialists to examine novel bioethical scientific issues and achieve technological country-specific goals. Focus on young scientist’s potential totally corresponds to the cross-cutting goal of axiological, prognostic and educational tasks of bioethics. Bioethical thinking is developed based on the experience of the school of ethics of scientific research, which is an educational project intended for young Russian researchers.
现代科学的迅猛发展扩大了生物伦理问题的范围。有关生物信息学、神经技术、遗传学、生物经济学、临床前和临床试验伦理方面的辩论正在积极展开。生物伦理公理学具有特殊的现实意义。它是有价值的范畴结构,决定了 "人类科学 "发展的优先次序,同时考虑到人与社会互动的历史经验,以及实际和前景(预后)意义上的文明变化标准。生物伦理公理的发展受到当前十年技术发展挑战的影响,这些问题客观上要求国家和社会做出反应。现代生物伦理学的主要任务之一是发展生物伦理学思想,以及在科学进程中使用生物伦理学公理的依据。健康公理是在学术过程中形成的对健康问题的一种固定的有意识的态度,随后将在劳动过程中使用,它是生物伦理思想的具体体现。生物伦理对话是至关重要的,因为它促使年轻的透视专家研究新的生物伦理科学问 题,实现国家的技术目标。关注青年科学家的潜力完全符合生物伦理学的公理、预测和教育任务的横向目标。生物伦理思想是在科学研究伦理学校的经验基础上发展起来的,该学校是一个针对俄罗斯青年研究人员的教育项目。
{"title":"School of research ethics. Axiology of bioethics and challenges of technological development","authors":"DE Firsov","doi":"10.24075/medet.2023.035","DOIUrl":"https://doi.org/10.24075/medet.2023.035","url":null,"abstract":"Intensive development of modern science expands the scope of bioethical issues. Debates on ethical aspects of bioinformatics, neurotechnology, genetics, bioeconomics, ethics of preclinical and clinical trials are actively developing. Axiology of bioethics is of particular relevance. It is the structure of valuable categories that determines the priorities of ‘human science’ development taking into account the historical experience of interaction between a person and community, and criteria of civilized changes in the actual and perspective (prognostic) sense. Development of bioethical axiology is influenced by the challenges of technological development of the current decade, the issues that objectively demand a reaction on the part of the state and society. One of the main tasks of modern bioethics is to develop bioethical thinking, and grounds for using bioethical axiology in the scientific process. Health axiology, which represents a fixed conscious attitude to the issues of health developed during the academic process to be subsequently used during a labor process, is practical expression of bioethical thinking. Bioethical dialogue is essential as it urges young perspective specialists to examine novel bioethical scientific issues and achieve technological country-specific goals. Focus on young scientist’s potential totally corresponds to the cross-cutting goal of axiological, prognostic and educational tasks of bioethics. Bioethical thinking is developed based on the experience of the school of ethics of scientific research, which is an educational project intended for young Russian researchers.","PeriodicalId":507498,"journal":{"name":"Медицинская этика","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140277469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ethical aspects, safety issues of cardiac surgery and prediction of adverse events 心脏手术的伦理问题、安全问题和不良事件预测
Pub Date : 2024-02-01 DOI: 10.24075/medet.2023.034
MV Shereshneva, MV Ilyin
In cardiac surgery, patient’s awareness and consent to surgery are problematic as due to the lack of previous medical background a patient can’t understand the processes occurring in the body and effects of exposure on them. Thus, provision of sufficient information by a doctor is a part of safe surgical strategy. An open randomized prospective trial involving 89 patients with stable coronary artery disease (CAD) was conducted. High rate of blood oxidation is believed to be an independent predictor of cognitive dysfunction development during the early postoperative period of coronary artery bypass grafting (CABG). Determination of blood oxidation rate is a tool of risk management during cardiac surgery starting from the stage of preoperative preparation, which is optimal to implement a safe strategy, including psychological and drug-induced support of the patient aimed at prevention of cognitive disturbances.
在心脏外科手术中,病人对手术的认识和同意是个问题,因为由于缺乏医学背景,病人无法理解体内发生的过程和暴露对他们的影响。因此,医生提供足够的信息是安全手术策略的一部分。一项开放式随机前瞻性试验涉及 89 名冠状动脉疾病(CAD)稳定期患者。高血液氧化率被认为是冠状动脉旁路移植术(CABG)术后早期出现认知功能障碍的独立预测因素。从术前准备阶段开始,血液氧化率的测定就是心脏手术风险管理的一个工具,它是实施安全策略的最佳选择,包括对患者进行心理和药物支持,以预防认知障碍。
{"title":"Ethical aspects, safety issues of cardiac surgery and prediction of adverse events","authors":"MV Shereshneva, MV Ilyin","doi":"10.24075/medet.2023.034","DOIUrl":"https://doi.org/10.24075/medet.2023.034","url":null,"abstract":"In cardiac surgery, patient’s awareness and consent to surgery are problematic as due to the lack of previous medical background a patient can’t understand the processes occurring in the body and effects of exposure on them. Thus, provision of sufficient information by a doctor is a part of safe surgical strategy. An open randomized prospective trial involving 89 patients with stable coronary artery disease (CAD) was conducted. High rate of blood oxidation is believed to be an independent predictor of cognitive dysfunction development during the early postoperative period of coronary artery bypass grafting (CABG). Determination of blood oxidation rate is a tool of risk management during cardiac surgery starting from the stage of preoperative preparation, which is optimal to implement a safe strategy, including psychological and drug-induced support of the patient aimed at prevention of cognitive disturbances.","PeriodicalId":507498,"journal":{"name":"Медицинская этика","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140466883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Analysis of requirements for confidentiality and exchange of digital health data 对数字健康数据保密和交换要求的分析
Pub Date : 2023-12-01 DOI: 10.24075/medet.2023.030
AK Alzubaidi
The article provides answers to immediate questions associated with the state regulation of confidentiality of information and exchange of data in the era of digital healthcare. The institute of medical confidentiality which originated in the ancient world is still evolving throughout the development of medical law. In the current era of global digitalization, however, the issues related to data confidentiality have become more relevant than ever. With all the modern technologies and digital health care platforms on the rise, new challenges associated with protection of these patients are emerging. To ensure the reliable protection of patient’s personal and medical information, doctors and medical institutions have to meet data security standards. It becomes vital to develop effective strategies and mechanisms to prevent unauthorized access and data leakage due to a larger volume of electronic medical records and digital data exchange. Strict rules and standards regulating collection, storage and transfer of medical data belong to a key aspect in this area. The Russian Federation is making great efforts to create the legislation which could protect the rights of patients and made medical establishments to follow the high standards of confidentiality, and to develop technical aids that provide data encryption and protection against hacker attacks.
文章回答了在数字医疗时代国家对信息保密和数据交换进行监管的相关迫切问题。起源于古代世界的医疗保密制度在整个医疗法的发展过程中仍在不断演变。然而,在当前全球数字化时代,与数据保密相关的问题比以往任何时候都更具现实意义。随着各种现代技术和数字医疗保健平台的兴起,与保护这些患者相关的新挑战也不断涌现。为了确保患者的个人信息和医疗信息得到可靠保护,医生和医疗机构必须达到数据安全标准。由于电子病历和数字数据交换量的增加,制定有效的策略和机制以防止未经授权的访问和数据泄漏变得至关重要。对医疗数据的收集、存储和传输进行严格监管的规则和标准是这一领域的一个关键方面。俄罗斯联邦正在努力制定立法,以保护患者的权利,使医疗机构遵守高保密标准,并开发技术辅助手段,提供数据加密和保护,防止黑客攻击。
{"title":"Analysis of requirements for confidentiality and exchange of digital health data","authors":"AK Alzubaidi","doi":"10.24075/medet.2023.030","DOIUrl":"https://doi.org/10.24075/medet.2023.030","url":null,"abstract":"The article provides answers to immediate questions associated with the state regulation of confidentiality of information and exchange of data in the era of digital healthcare. The institute of medical confidentiality which originated in the ancient world is still evolving throughout the development of medical law. In the current era of global digitalization, however, the issues related to data confidentiality have become more relevant than ever. With all the modern technologies and digital health care platforms on the rise, new challenges associated with protection of these patients are emerging. To ensure the reliable protection of patient’s personal and medical information, doctors and medical institutions have to meet data security standards. It becomes vital to develop effective strategies and mechanisms to prevent unauthorized access and data leakage due to a larger volume of electronic medical records and digital data exchange. Strict rules and standards regulating collection, storage and transfer of medical data belong to a key aspect in this area. The Russian Federation is making great efforts to create the legislation which could protect the rights of patients and made medical establishments to follow the high standards of confidentiality, and to develop technical aids that provide data encryption and protection against hacker attacks.","PeriodicalId":507498,"journal":{"name":"Медицинская этика","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139191030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Real-world data in legal framework of the Russian Federation 俄罗斯联邦法律框架中的真实世界数据
Pub Date : 2023-12-01 DOI: 10.24075/medet.2023.031
M. Borzova, VV Kalinichenko, A. Kolbin
The real-world data (RWD) constitute a modern trend in the healthcare system and in the structure of taking decisions. The trend is being actively developed in the Russian Federation. Ethical aspects of these trials and legal regulation of RWD are, however, still unresolved. In this paper, development of the legal field and national regulation of RWD in Russia is discussed during registration, assessment of healthcare technologies, management of patient registries, and development of clinical recommendations. It is shown that the acting regulatory field of the Russian Federation contains no bans on the use of RWD to support regulatory decisions. Nevertheless, the existing legal laws set limited opportunities for practical application and accounting of RWD by the competent authority. In conclusion, recommendations on further development of RWD legal field in Russia are provided.
真实世界数据(RWD)是医疗系统和决策结构的现代趋势。俄罗斯联邦正在积极发展这一趋势。然而,这些试验的伦理问题和真实世界数据的法律监管问题仍未得到解决。本文讨论了俄罗斯在注册、医疗保健技术评估、患者登记管理和临床建议制定等方面的法律领域发展和国家对 RWD 的监管。结果表明,俄罗斯联邦的行为监管领域没有禁止使用 RWD 支持监管决策。不过,现行法律为主管当局实际应用和核算 RWD 提供了有限的机会。最后,还就进一步发展俄罗斯的 RWD 法律领域提出了建议。
{"title":"Real-world data in legal framework of the Russian Federation","authors":"M. Borzova, VV Kalinichenko, A. Kolbin","doi":"10.24075/medet.2023.031","DOIUrl":"https://doi.org/10.24075/medet.2023.031","url":null,"abstract":"The real-world data (RWD) constitute a modern trend in the healthcare system and in the structure of taking decisions. The trend is being actively developed in the Russian Federation. Ethical aspects of these trials and legal regulation of RWD are, however, still unresolved. In this paper, development of the legal field and national regulation of RWD in Russia is discussed during registration, assessment of healthcare technologies, management of patient registries, and development of clinical recommendations. It is shown that the acting regulatory field of the Russian Federation contains no bans on the use of RWD to support regulatory decisions. Nevertheless, the existing legal laws set limited opportunities for practical application and accounting of RWD by the competent authority. In conclusion, recommendations on further development of RWD legal field in Russia are provided.","PeriodicalId":507498,"journal":{"name":"Медицинская этика","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139192242","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Medicinal product early access programs: experience of the BRICS group, European Union, and United States of America 医药产品早期获取计划:金砖五国集团、欧洲联盟和美利坚合众国的经验
Pub Date : 2023-11-01 DOI: 10.24075/medet.2023.029
VV Оmelyanovskiy, NP Rukavitsyna, P. Mukhortova, AA Kingshott, SI Zinadinov, AG Kharitonova, EI Minakova, LO Krekhtunova, VO Barysheva
Timely accessibility of effective and safe medicinal products is one of the main tasks of healthcare. The goal of the present review is to assess various approaches that provide an early access to medicinal products within the BRICS group (list of participants as of 01.10.2023), European Union and United States of America. The stage of the life cycle of medicinal products is closely associated with their further movement in the market, patient access rate, and partially with the issues of their financing and reimbursement, which directly influence their affordability for population. The article contains data about the specifics of expanded access to unregistered medicinal products used on a compassionate basis and presenting therapy under early access programs financed by pharmaceutical companies; it also describes approaches to accelerated registration and registration of medicinal products in case of limited clinical data. Experience of the reviewed countries in early access programs is described.
及时获得有效、安全的医药产品是医疗保健的主要任务之一。本综述的目的是评估金砖五国集团(截至 2023 年 10 月 1 日的参与国名单)、欧盟和美国提供早期获取医药产品的各种方法。医药产品生命周期的阶段与它们在市场上的进一步发展、患者使用率密切相关,部分与它们的融资和报销问题有关,这些问题直接影响着人们对它们的承受能力。这篇文章包含了有关扩大未注册医药产品的使用范围的具体数据,这些产品是在同情基础上使用的,并在制药公司资助的早期使用计划下进行治疗;文章还介绍了在临床数据有限的情况下加快医药产品注册和登记的方法。报告还介绍了受审查国家在早期使用计划方面的经验。
{"title":"Medicinal product early access programs: experience of the BRICS group, European Union, and United States of America","authors":"VV Оmelyanovskiy, NP Rukavitsyna, P. Mukhortova, AA Kingshott, SI Zinadinov, AG Kharitonova, EI Minakova, LO Krekhtunova, VO Barysheva","doi":"10.24075/medet.2023.029","DOIUrl":"https://doi.org/10.24075/medet.2023.029","url":null,"abstract":"Timely accessibility of effective and safe medicinal products is one of the main tasks of healthcare. The goal of the present review is to assess various approaches that provide an early access to medicinal products within the BRICS group (list of participants as of 01.10.2023), European Union and United States of America. The stage of the life cycle of medicinal products is closely associated with their further movement in the market, patient access rate, and partially with the issues of their financing and reimbursement, which directly influence their affordability for population. The article contains data about the specifics of expanded access to unregistered medicinal products used on a compassionate basis and presenting therapy under early access programs financed by pharmaceutical companies; it also describes approaches to accelerated registration and registration of medicinal products in case of limited clinical data. Experience of the reviewed countries in early access programs is described.","PeriodicalId":507498,"journal":{"name":"Медицинская этика","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139306062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Education, health, and mercy. Training sisters of mercy at the Yaroslavl Medical University 教育、健康和仁慈在雅罗斯拉夫尔医科大学培训怜悯修女
Pub Date : 2023-11-01 DOI: 10.24075/medet.2023.027
AL Khokholov, PS Zhbannikov, AYu Zarov, DE Firsov, AV Shkurankov, SV Makarov
In the modern world, traditions of social work are highly demanded both by the professional medical corporation and entire society. The experience of hospital volunteering is particularly relevant in relation to palliative patients. Volunteers involved in practical healthcare should have the corresponding level of qualification. The issue is solved by training and retraining of hospital volunteers and specialists of various levels at medical educational institutions. Junior medical nurses (sisters of mercy) have been trained at the Yaroslavl State Medical University since 2023. The specialized department of palliative medicine on the basis of Clinical Central Hospital of St. Alexy Metropolitan of Moscow of the Moscow Patriarchate of the Russian Orthodox Church was created at the Yaroslavl State Medical University. It is the interaction with state, social and confessional structures that allows to solve issues of practical implementation of the skills obtained by volunteers considering a wide range of community demands.
在现代社会,专业医疗机构和整个社会都对社会工作的传统有着很高的要求。医院志愿服务的经验与姑息治疗病人尤其相关。参与实际医疗工作的志愿者应具备相应的资格水平。这个问题可以通过在医疗教育机构对医院志愿者和各级专家进行培训和再培训来解决。雅罗斯拉夫尔国立医科大学自 2023 年起开始培训初级医疗护士(仁慈修女)。雅罗斯拉夫尔国立医科大学在俄罗斯东正教莫斯科牧首区莫斯科圣阿列克谢都主教临床中心医院的基础上成立了姑息医学专科系。正是通过与国家、社会和教派机构的互动,才得以解决志愿者在考虑到广泛的社区需求的情况下所获得的技能的实际应用问题。
{"title":"Education, health, and mercy. Training sisters of mercy at the Yaroslavl Medical University","authors":"AL Khokholov, PS Zhbannikov, AYu Zarov, DE Firsov, AV Shkurankov, SV Makarov","doi":"10.24075/medet.2023.027","DOIUrl":"https://doi.org/10.24075/medet.2023.027","url":null,"abstract":"In the modern world, traditions of social work are highly demanded both by the professional medical corporation and entire society. The experience of hospital volunteering is particularly relevant in relation to palliative patients. Volunteers involved in practical healthcare should have the corresponding level of qualification. The issue is solved by training and retraining of hospital volunteers and specialists of various levels at medical educational institutions. Junior medical nurses (sisters of mercy) have been trained at the Yaroslavl State Medical University since 2023. The specialized department of palliative medicine on the basis of Clinical Central Hospital of St. Alexy Metropolitan of Moscow of the Moscow Patriarchate of the Russian Orthodox Church was created at the Yaroslavl State Medical University. It is the interaction with state, social and confessional structures that allows to solve issues of practical implementation of the skills obtained by volunteers considering a wide range of community demands.","PeriodicalId":507498,"journal":{"name":"Медицинская этика","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139302612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
On justifiability of animal research (based on the article by Cameron Shelley entitled ‘Why test animals to treat humans? on the validity of animal models’) 关于动物研究的合理性(根据卡梅伦-雪莱(Cameron Shelley)题为 "为什么用动物实验来治疗人类?
Pub Date : 2023-11-01 DOI: 10.24075/medet.2023.026
HG Lugowska
The article sums up the pros and cons regarding the animal models selected and critically explored by Cameron Shelley in the article entitled ‘Why test animals to treat humans? On the validity of animal models’. Special attention is given to the adaptation of the topic-related English version of this discourse for a Russian-speaking reader. Arguments of supporters and opponents of animal models provided by C. Shelley are reviewed. The issue of the effective use of animals in biomedical research considering the validity criterion is being discussed. The connection between the validity and morality of an animal model suggested by C. Shelley is further elaborated. According to C. Shelley, out of three critical arguments for animal modeling, the pseudoscience argument and the disanalogy argument do not work, as the pressing issues they raise are interpreted by supporters in the wrong way. The predictive validity argument is not sufficient, as the doubts raised about the predictive power of animal models are either not supported or lack clear formulation. C. Shelley states that assessing the validity of an animal model is a complex task, which includes various approaches to determining the extent of model validity as appropriate, and defines the problem as an issue of determining the type of validity and its effect on the assessed morality of an animal model. According to the author, ethical issues come down to pragmatics of validity as a criterion capable of disorientating critics of animal modeling or at least reconciling them with the necessity and inevitability of animal experiments.
文章总结了卡梅隆-雪莱在题为《为什么用动物实验治疗人类?论动物模型的有效性 "一文中,卡梅伦-雪莱所选择和批判探讨的动物模型的利弊。文章特别注意为俄语读者改编了与主题相关的英文版论述。C. Shelley 提供的动物模型支持者和反对者的论点进行了评述。讨论了在生物医学研究中有效使用动物的有效性标准问题。C. Shelley 提出的动物模型的有效性与道德性之间的联系得到了进一步阐述。根据 C. Shelley 的观点,在动物模型的三个关键论据中,伪科学论据和二元对立论据不起作用,因为支持者以错误的方式解释了它们提出的紧迫问题。预测有效性论证不充分,因为对动物模型预测能力提出的质疑要么没有得到支持,要么缺乏清晰的表述。C. Shelley 指出,评估动物模型的有效性是一项复杂的任务,其中包括酌情确定模型有效性程度的各种方法,并将这一问题定义为确定有效性类型及其对动物模型所评估的道德性的影响问题。作者认为,伦理问题归根结底是有效性的实用性问题,有效性作为一种标准,能够使动物模型的批评者迷失方向,或至少使他们与动物实验的必要性和必然性相协调。
{"title":"On justifiability of animal research (based on the article by Cameron Shelley entitled ‘Why test animals to treat humans? on the validity of animal models’)","authors":"HG Lugowska","doi":"10.24075/medet.2023.026","DOIUrl":"https://doi.org/10.24075/medet.2023.026","url":null,"abstract":"The article sums up the pros and cons regarding the animal models selected and critically explored by Cameron Shelley in the article entitled ‘Why test animals to treat humans? On the validity of animal models’. Special attention is given to the adaptation of the topic-related English version of this discourse for a Russian-speaking reader. Arguments of supporters and opponents of animal models provided by C. Shelley are reviewed. The issue of the effective use of animals in biomedical research considering the validity criterion is being discussed. The connection between the validity and morality of an animal model suggested by C. Shelley is further elaborated. According to C. Shelley, out of three critical arguments for animal modeling, the pseudoscience argument and the disanalogy argument do not work, as the pressing issues they raise are interpreted by supporters in the wrong way. The predictive validity argument is not sufficient, as the doubts raised about the predictive power of animal models are either not supported or lack clear formulation. C. Shelley states that assessing the validity of an animal model is a complex task, which includes various approaches to determining the extent of model validity as appropriate, and defines the problem as an issue of determining the type of validity and its effect on the assessed morality of an animal model. According to the author, ethical issues come down to pragmatics of validity as a criterion capable of disorientating critics of animal modeling or at least reconciling them with the necessity and inevitability of animal experiments.","PeriodicalId":507498,"journal":{"name":"Медицинская этика","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139305217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Medical students in clinical training: ethical aspects 临床培训中的医学生:伦理问题
Pub Date : 2023-11-01 DOI: 10.24075/medet.2023.028
VA Deeva, EV Guseva, VS Demyanov, PA Isaeva, MA Polushkina, DM Ruck, AS Tihonova, TG Kim
The article is devoted to ethical aspects of bedside training. Education of future specialists in the clinical setting is important to acquire knowledge, skills, professional competencies and to form clinical thinking. Transfer of professional medical experience occurs simultaneous to the development of communication skills which are required to deal with patients, their relatives, colleagues and mentors. It is about comprehension of how the normal standards of medical deontology are implemented in real practice and how important the effective therapeutic alliance is while interacting with the patient. Though bedside training is a long-standing tradition of medical education, the origins of which are associated with the Ancient Greek Healing Practices, it is not always understood and supported by patients and their relatives, and requires students to get more familiar with ethical standards regulating similar education and their behavior within a medical group and institution.
这篇文章专门讨论了床边培训的伦理问题。在临床环境中对未来的专科医生进行教育对于获取知识、技能、专业能力和形成临床思维非常重要。在传授专业医疗经验的同时,还要培养与病人、病人亲属、同事和导师打交道所需的沟通技巧。这关系到如何在实际工作中执行正常的医学义务标准,以及在与病人互动时有效的治疗联盟有多么重要。虽然床旁培训是医学教育的一个悠久传统,其起源与古希腊的治疗实践有关,但并不总是能得到病人及其亲属的理解和支持,这就要求学生更加熟悉规范类似教育的道德标准以及他们在医疗团体和机构中的行为。
{"title":"Medical students in clinical training: ethical aspects","authors":"VA Deeva, EV Guseva, VS Demyanov, PA Isaeva, MA Polushkina, DM Ruck, AS Tihonova, TG Kim","doi":"10.24075/medet.2023.028","DOIUrl":"https://doi.org/10.24075/medet.2023.028","url":null,"abstract":"The article is devoted to ethical aspects of bedside training. Education of future specialists in the clinical setting is important to acquire knowledge, skills, professional competencies and to form clinical thinking. Transfer of professional medical experience occurs simultaneous to the development of communication skills which are required to deal with patients, their relatives, colleagues and mentors. It is about comprehension of how the normal standards of medical deontology are implemented in real practice and how important the effective therapeutic alliance is while interacting with the patient. Though bedside training is a long-standing tradition of medical education, the origins of which are associated with the Ancient Greek Healing Practices, it is not always understood and supported by patients and their relatives, and requires students to get more familiar with ethical standards regulating similar education and their behavior within a medical group and institution.","PeriodicalId":507498,"journal":{"name":"Медицинская этика","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139297238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Медицинская этика
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1