医疗康养科技杂谈MedicalHealthTechTalks丨撒妮阳Sunny

撒妮阳Sunny丨사니양丨GreenBambooLeansRattan
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适时播报国内外医疗健康养生方面的讯息知识，日常生活懂点医，让思想走在时代前端，跟上科技发展的步伐，有助于个人健康管理和提高产业经济发展。 Timely broadcast of information and knowledge on medical and health care at home and abroad,Understand some medicine in daily life, let the mind walk in the forefront of the times, and keep up with the pace of scientific and technological development.It contributes to personal health management and improves the development of industrial economy.

Episodes

  1. No.4-细胞和基因治疗产品临床相关沟通交流技术指导原则（2023年）

    FEB 25

    No.4-细胞和基因治疗产品临床相关沟通交流技术指导原则（2023年）

    近年来，细胞和基因治疗技术取得了显著进展，全球范围内已有多款相关产品获批上市。此类治疗方法通过基因编辑和细胞修饰，提供了新的治疗策略，但其复杂性也带来了潜在的安全风险。为了确保临床试验的成功，申请人需在试验前与审查中心充分沟通，制定详尽的研发和风险管理计划。该播客将深入探讨细胞和基因治疗的前沿进展、临床应用及其面临的挑战，帮助听众了解这一领域的最新动态和未来前景。 00:02:00:上市许可申请前的沟通交流：数据充分支持与研究可行性 00:04:01:产品设计原理与治疗作用机制：创新基因治疗方法的探索与发展 00:06:04:优化适应症人群：关键确证性临床试验方案制定的重要性和科学性 00:08:07:细胞和基因治疗产品临床试验设计建议：以产品特点和科学制定为基础 00:10:16:关键确证性临床试验方案的设计与适用性：细胞和基因治疗产品的特殊性与挑战 00:12:50:临床试验前的产品安全性评估：分析非临床研究数据以及同类产品安全性风险 00:15:20:关键确证性试验前的沟通交流：确保入选受试者的一致性与疾病类型的共识 00:17:59:全面解读干细胞治疗：适应症、试验设计和基因修饰的关键因素 00:20:32:细胞治疗产品安全性评估：考虑疾病严重程度和临床试验设计的重要性 00:23:06:个体化免疫细胞治疗产品：临床试验设计与沟通交流重点关注的问题 00:25:42:细胞和基因治疗产品临床试验沟通交流申请必备要点 00:28:03:溶瘤病毒药物研发进展：基因改造与载体风险评估

    31 min
  2. No.3-体外基因修饰系统药学研究与评价技术 指导原则（试行）

    FEB 19

    No.3-体外基因修饰系统药学研究与评价技术 指导原则（试行）

    近年来，细胞治疗和基因编辑技术迅速发展，为治疗严重和难治性疾病带来了新的希望。基因修饰系统通过将外源基因导入细胞，改变基因表达或调节细胞特性，成为肿瘤治疗的前沿手段。慢病毒载体、电网逆转录病毒载体等常用于将基因导入T细胞，实现对肿瘤的靶向杀伤。随着技术不断进步，基因修饰系统的质量控制和安全性研究至关重要。本期播客将深入探讨这些前沿技术及其应用，了解基因治疗的最新进展。 00:02:04:基因修饰系统的设计合理性与工艺稳定性研究：药学研究的关键环节 00:05:12:基因修饰系统商业化工艺确证性临床试验前的变更控制与质量研究建议 00:10:23:研发者应关注基因修饰系统的设计与构建，以确保细胞产品的安全性和有效性。 00:15:34:GAMA逆转录病毒载体：基因修饰与改造方法的进展与展望 00:20:49:完整确认智力的核苷酸序列，避免抗性基因插入病毒载体基因组中 00:26:01:建议开展风险分析与研究：评估病毒载体包装过程中非载体DNA序列的风险。 00:31:13:病毒载体制备工艺研究与开发：关注病毒毒性和细胞培养条件的影响 00:36:28:病毒载体制备中的纯化工艺研究与质量标准制定 00:41:41:建议关注病毒载体类型及转导低度的适用性，以检测感染能力。 00:46:54:基因修饰系统质量标准与检测项目探讨：非病毒载体类的特异性与有效性分析 00:52:07:基因修饰系统制备过程中的关键原材料和工艺参数研究 00:57:20:质量标准的建立与分析：基因修饰系统中残留物质的评估与控制

    1h 3m
  3. No.2-How to shape medical and elderly care model

    FEB 18

    No.2-How to shape medical and elderly care model

    Preface: The issue of aging population has attracted a lot of attention. The susceptibility, suddenness, and slow deterioration of "geriatric diseases" have become one of the main problems that plague the happy life of families. The aging problem has brought about the problem of insufficient allocation of social resources in healthcare and elderly care, as well as a significant mental and economic burden on children. How to effectively solve these problems and how the medical and elderly care model will develop has begun to enter people's vision and thinking, which has attracted great attention from relevant government departments. Business people from all walks of life have also transformed and invested in the innovation of the medical and elderly care model. The medical and elderly care model mainly refers to the combination of medical resources and elderly care resources to achieve the maximum utilization of social resources.1、 The Importance of Shaping the Future Medical and Elderly Care Model in China's Big Health IndustryFor the integration of medical care and elderly care, it is to provide specialized medical consultation and rehabilitation treatment services for the elderly on the basis of traditional elderly care models, in order to strengthen the protection of the health of the elderly. With the continuous development of our society, the aging population in China is gradually intensifying, which has also received high attention from the government. The government needs to continuously improve relevant laws and regulations, take the lead, and drive the entire society to participate in order to break through the "bottlenecks" in elderly care service work. Based on home care, relying on the community, and supplemented by medical institutions, we will fully improve the health management system and legal regulations that integrate medical care and elderly care, and meet the needs of social elderly care.The state regards the right to health as a fundamental human right and protects it. While solving the problem of people seeking medical treatment and medication, it also provides social welfare that guarantees the physical and mental health of the people. At present, big health is essentially a broad concept of health, which has evolved with the extension of people's health concepts. It revolves around people's clothing, food, housing, transportation, birth, aging, sickness, and death, focusing on various factors and misconceptions that affect health, and emphasizing and promoting self health management.The big health industry in China is gradually showing a vigorous development trend. According to relevant data, as of 2020, the market size of the big health industry brought by "Healthy China" is expected to reach about 1 billion yuan. Shaping the future medical and elderly care model under China's big health industry is conducive to improving the professional medical and rehabilitation services for the elderly, improving their daily mental life, enhancing the health quality of elderly and chronic disease patients, and reducing the pressure on social medical resources and government medical insurance funds, thereby enhancing social resource integration and family happiness.2、 Overview of medical and elderly care modeIn China, aging population, policy driven, industrial technology accumulation and people's demand for health are all key factors to promote the development of China's massive health industry. The integrated medical and elderly care model is based on the traditional elderly care model, providing specialized medical and rehabilitation services for the elderly. In the medical and elderly care model, "medical" refers to medical rehabilitation and healthcare services, including medical services, health checkups, health consultations, etc. "Elderly care" mostly refers to life care services, cultural activity organization, spiritual and psychological comfort, food and medicine health preservation, etc. for the elderly. The integration of medical care and elderly care is not simply a combination of medical treatment and elderly care. It is a new development model that integrates medical treatment, rehabilitation, health preservation, and health care, placing the health management of the elderly at the forefront, organically combining elderly care institutions and medical resources, and integrating life care and medical rehabilitation and health care for the elderly. To achieve deep integration and coordinated development of medical resources and elderly care resources, in order to better meet the medical and rehabilitation needs of the elderly, help them maintain physical and mental health, and effectively reduce the burden on families and society.3、 Analysis of the Shortcomings of the Medical and Elderly Care Model in China's Big Health IndustryThe integration of medical care and elderly care, as a new type of elderly care, is gradually receiving market attention. However, there are still many shortcomings in the integration of medical care and elderly care. Firstly, there is a shortage of human resources required under the integrated medical and elderly care model, especially a shortage of high-quality specialized talents. The number of medical and social workers engaged in elderly medical care and rehabilitation in China is insufficient, and the cultural quality of practitioners is low, with high job mobility, which greatly restricts the formation and development of the integrated management model of medical care and elderly care. Secondly, the current guarantee system for the integration of medical care and elderly care in China is not perfect enough, lacking innovative and practical measures, and unable to develop service models based on the health characteristics and actual needs of elderly patients. There are huge loopholes in legal provisions regarding the attribution of responsibility and personal safety for elderly medical care and elderly care, and the medical insurance fund has not yet been directly connected with medical care institutions for settlement. Finally, the profit model of the medical and elderly care model is not clear enough, with low barriers to intellectual property and patent protection, and has not yet formed a direct, clear, standardized, and consensus commercial operation model.4、 Strategies for Shaping Future Medical and Elderly Care Models in China's Big Health IndustryAfter the implementation of the "13th Five Year Plan" proposal, Healthy China has officially upgraded to a "national strategy". In order to further promote the development of the big health industry, relying on the big health industry to achieve innovation in the medical and elderly care model, and further promote the improvement of the medical and elderly care model. Based on the actual development situation in China, we will conduct an in-depth analysis of the strategies for shaping the future medical and elderly care model in the context of China's big health industry, in order to help more families solve various problems caused by "geriatric diseases".（1） Medical Extended Care ModelWith the development of population aging in China, the number of disabled and semi disabled elderly people is increasing, and the number of disabled elderly people is increasing year by year. According to relevant data analysis and prediction, by 2020, there will be over 42 million disabled elderly people and over 29 million elderly people aged 80 and above in China. This huge number not only needs to solve the problem of elderly care, but also has a huge demand for medical and rehabilitation services. The extended care model from medical institutions is an extension and development of the grassroots elderly care field through the downstream sedimentation of medical and health institutions. By setting up elderly beds in hospitals, with medical institutions as the main body, elderly care institutions and health management centers are established. At the same time, specialized departments such as geriatrics, comprehensive medicine, and traditional Chinese medicine health care should be established within medical institutions to promote their transformation into comprehensive medical rehabilitation institutions that can provide integrated medical and elderly care services. Relatively speaking, this approach has a high market acceptance, but it puts significant operational pressure on medical institutions.（2） The model of adding doctors to the care systemThe development of the integrated medical and elderly care model is bound to drive new changes in the health industry and improve people's understanding of health management to a certain extent. It will change the traditional and simple approach of treating diseases and seeking medical treatment, and gradually shift towards the direction of preventive medicine and health care medicine. The model of combining elderly care with medical care mainly refers to the allocation of medical resources in large-scale elderly care institutions, which is currently the most common development model of medical and elderly care integration. The model of adding medical care to elderly care facilities involves setting up medical rooms, nursing stations, health cabins, intervention areas, or setting up specialized medical institutions such as geriatric hospitals, nursing hospitals, rehabilitation hospitals, etc. in nursing homes, parks, and day care centers to ensure that elderly patients who settle in nursing homes can enjoy the necessary medical services, in order to provide them with necessary medical care services in their elderly life. The development of the elderly care model can to some extent increase the health protection of elderly care projects, broaden the income channels of institutions, and effectively alleviate operational pressure. Therefore, the model of nourishing and adding medicine has been widely recognized and applied in the commercial market.（3） Medica

    14 min
  4. No.2-思考中国大健康产业如何塑造未来医养模式

    FEB 17

    No.2-思考中国大健康产业如何塑造未来医养模式

    医养结合模式的未来发展人口老龄化带来的医疗和养老问题日益突出。医养结合模式成为解决这一问题的重要手段，通过将医疗资源和养老资源相结合，为老年人提供专业的医疗和康复服务。医养结合模式不仅能提高老年人的生活质量，还能减轻家庭和社会的负担。然而，这一模式在实施过程中仍面临人力资源短缺、保障体系不完善等挑战。通过创新和技术手段，未来的医养模式有望更好地服务社会，成为大健康产业的重要组成部分。00:02:00:中国大健康产业发展趋势：医养结合模式的前景与挑战00:04:03:深入分析中国大健康产业发展医氧模式的策略00:06:07:医养结合：提升老年人生活品质的关键步骤00:08:11:居家社区养老加医疗网络模式：医养结合走进街道、社区家庭00:10:14:人口老龄化：大健康产业发展面临的挑战与机遇

    11 min

  5. FEB 17

    No.1-How to quickly eliminate lactic acid

    There are two substances in the human body that are harmful, one is lactic acid and the other is oxygen free radicals.During my research at the Provincial Academy of Sciences, I frequently came into contact with these two medical terms. Many years ago, I mainly engaged in the development of pacemakers, extracorporeal counterpulsors, catheters and stents for minimally invasive cardiac surgery, as well as television endoscopic surgical systems. So there is less awareness.Today we will first introduce lactic acid, which belongs to carboxylic acids. (AHA) contains hydroxyl groups and can release a proton from its carboxyl group in aqueous solution to produce lactic acid.The production of lactic acid cannot be avoided, as long as the human body is metabolized and exercising, lactic acid will be produced. Lactic acid is a waste generated by human movement.The chemical reaction process will be omitted. When the human body is not exercising, the lactate in the blood is maintained at 1-2 mmol/L, and when it is strongly exercised, it will rise to 20 mmol/L.This is because the energy of the body's tissues cannot be satisfied through aerobic respiration, or in other words, the tissues cannot process oxygen quickly enough, resulting in an increase in lactate concentration. In this case, pyruvate dehydrogenase cannot convert pyruvate into acetyl CoA in a timely manner, and pyruvate accumulates (acidic substance).In muscle cells with sufficient oxygen, lactate is directly used as fuel for the tricarboxylic acid cycle. Glucose can also be generated in the hepatic gluconeogenesis cycle.When it comes to fuel, there will be "combustion". We can explain the "combustion" of lactic acid in the human body by giving a familiar phenomenon. For example, natural gas combustion. The chemical formula of natural gas is CH4, which contains 4 hydrogens and 1 carbon that can be burned. Let's first take a look at the chemical formula of lactic acid: C3H6O3， There are still 3 carbons, 6 hydrogens, and 3 oxygens that can be burned. That is to say, lactic acid can really be "burned" by tissues in the human body.Just like carbon monoxide (CO), when it enters the bloodstream, it easily combines with hemoglobin to form carboxyhemoglobin, causing it to lose its ability and efficacy in carrying oxygen, leading to tissue suffocation and necrosis, and in severe cases, death. If CO is enriched with oxygen and "burned" to become carbon dioxide (CO2), all the thermal energy of CO can be burned off and discharged from the body.The same principle applies to the combustion of carbon, hydrogen, and oxygen in lactic acid. When the thermal energy of lactic acid is lost, it means it has been destroyed.At this point, everyone will understand:The fundamental premise is to reduce the production of lactic acid.The most cost-effective way to reduce lactate is to lie down and rest, keeping metabolism in the slowest state, with low oxygen consumption and relatively high blood oxygen saturation. The high cost is to use small oxygen cylinders to provide oxygen to muscle cells.2. The second is to enrich cells with oxygen as much as possible, helping to "burn" lactate in the body through oxygen enrichment, which is why we advocate for "oxygen enriched exercise".In addition to the above-mentioned oxygen therapy, hot compress, hot bath, massage, etc. can also be used. The principle is the same as above, which is to disperse lactic acid out of the body through heat.However, in the case of being infected with the virus, it is recommended to take fewer showers because at this time, people's physical condition is poor and they are prone to catching a cold, which can cause the condition to recur. But soaking feet in hot water can also have an effect.3. Another way is to drink more alkaline water, eat alkaline fruits, food, etc. When a person is in an alkaline state, they are relatively healthy.Generally, alkaline water contains calcium (water with calcium content>85mg/L). The interaction between calcium ions and lactic acid can generate higher levels of calcium lactate than lactic acid, which can be excreted from the urinary system. I have also been taking sodium bicarbonate tablets, alkaline water, and other medications to regulate and reduce uric acid, which are very effective.4. The final solution is to drink plenty of water, especially alkaline water with a pH value of 7 or above. Regardless of viral or bacterial infections, drinking plenty of water can accelerate the body's metabolism and eliminate lactic acid through the secretion system such as sweating, urination, and defecation. This is a common sense method.

    5 min

  6. FEB 17

    No.1-如何快速排除乳酸？轻松告别乳酸积聚恢复活力指南

    如何快速排出乳酸。 人体中有两种物质是对人体有害的，一个是乳酸，另一个是氧自由基。 这两个医学名词，我在省科学院研究期间就经常接能触，多年前我主要从事心脏起搏器、体外反搏器、心脏微创手术用导管、支架、及电视内镜手术系统的研制。所以有少点认知。 我们今天这里先介绍乳酸，乳酸属于羧酸，（AHA）含有羟基，能在水溶液中其羧基中释放一个质子，而产生乳酸。 乳酸的产生是不能避免的，只要人体在新陈代谢，在运动就会产生乳酸。乳酸是人体运动而产生的废弃物。 其化学反应过程就省略不说了，人体在不运动时血液中乳酸维持在1～2mmol／L，当强烈运动时会上升到20mmol／L。 这是因为机体组织能量无法通过有氧呼吸而获得滿足，或者说，组织无法在足够快的情况下处理氧而致使乳酸浓度升高。这种情况下丙酮酸脱氢酶无法及时把丙酮酸转化为乙酰辅酶A，丙酮酸就会堆积（酸性物质）。 在氧气充足的肌肉细胞中，乳酸会被直接作为三羧酸循环的燃料。也可在肝脏糖异生的循环生成葡萄糖。 说到燃料就会有“燃烧”，我们可以举个大家熟悉的现象来解读乳酸在人体的“燃烧＂，举例天然气燃烧吧，天然气的化学式是CH4，有4个氢，1个碳可以燃烧，再先看下乳酸的化学式是：C3H6O3，即还有3个C，6个氢，3个氧可以燃烧。就是说，乳酸真的可以被人体内组织“燃烧”。 就如一氧化碳（CO），当其进入血液中后极容易与血红蛋白结合生成碳氧血红蛋白，使其丧失携带氧的能力和功效，使组织窒息坏死，严重的会致人死亡。如將CO被富氧“燃烧”后，变成二氧化碳（CO2），把CO的热能全烧掉就可以排出体外。 而换到乳酸中的碳、氢、氧热能燃掉一样道理，当乳酸的热能失去了，也就意味着被破灭了。 说到这里，大家会明白了： 1，根本的前提是减少乳酸的产生。 要减少乳酸的办法性价比最高的，就是躺下休息，让新陈代谢处于最缓慢状态，耗氧低，血氧饱和度相对高。而成本高的，就是使用小的氧气瓶吸氧，使肌肉细胞富氧。 2，第二个是尽可能让细胞富氧，通过富氧帮助把乳酸在体内的“燃烧＂，这就是我们为什么要提倡“富氧运动”。 除了上述吸氧外，还可以用热敷，洗热水澡，按摩等，其原理与上相同，就是通过热把乳酸逼散发出体外。 但是在中招阳了的病情下，建议还是少洗澡，因为这时候人的体质较差，容易着凉使病情反复。但可以用热水泡脚效果也可以的。 3，还有就是多喝碱性水，吃碱性水果，食物等，当人处于碱体质时相对是健康的。 一般碱性水都含钙（含钙元素>85mg/L的水），钙离子和乳酸作用，可以生成比乳酸更高的乳酸钙，可以在泌尿系统把乳酸排出体外。我本人也一直服用碳酸氢钠片、碱性水…等调理降低尿酸，很有效果。 4，最后一个办法就是多喝水，尤其是喝PH值7以上的碱性水，无论病毒，细菌感染，多喝水都可以加快人体的新陈代谢，通过发汗，排尿，大便等分泌系统把乳酸排出，这是常识性的办法。

    4 min
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适时播报国内外医疗健康养生方面的讯息知识，日常生活懂点医，让思想走在时代前端，跟上科技发展的步伐，有助于个人健康管理和提高产业经济发展。 Timely broadcast of information and knowledge on medical and health care at home and abroad,Understand some medicine in daily life, let the mind walk in the forefront of the times, and keep up with the pace of scientific and technological development.It contributes to personal health management and improves the development of industrial economy.

Information