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Insulin-Related Consumables Should not be Ignored While Pooling Insulin Purchases: Experience From China 胰岛素相关耗材在集中采购时不可忽视:来自中国的经验
IF 3.3 Pub Date : 2025-12-15 DOI: 10.1002/hcs2.70046
Jingya Zhang, Haoran Li, Ning Zhang, Ying Mao, Bin Zhu

A series of measures to implement national volume-based procurement (NVBP) and follow-on NVBP in China have significantly reduced insulin prices and increased patient affordability. However, NVBP may lead to a higher burden of insulin-related consumables (such as injection pens and needles), which might discourage patients from using insulin in the pooled list and increase the risk of needle reuse. This article emphasizes that it is essential NVBP be implemented for both drugs and consumables, which will contribute to the achievement of universal insulin access.

中国实施国家批量采购(NVBP)和后续NVBP的一系列措施显著降低了胰岛素价格,提高了患者的负担能力。然而,NVBP可能会导致胰岛素相关耗材(如注射笔和针头)的负担增加,这可能会使患者不愿在汇总清单中使用胰岛素,并增加针头重复使用的风险。本文强调在药品和消耗品中实施NVBP是必要的,这将有助于实现普遍胰岛素可及性。
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引用次数: 0
Development on the Proficiency of Diagnosis and Clinical Care for Rare Diseases in Young Physicians in China 中国青年医师罕见病诊断和临床护理水平的发展。
IF 3.3 Pub Date : 2025-12-13 DOI: 10.1002/hcs2.70042
Ge Wu, Yongzhang Miao, Siyuan Fan, Wanru Duan, Junyan Qian, Dawei Wu, Eray Yihui Zhou, Zhongli Xu, Jing Xie, Mengchun Gong, Shuyang Zhang

Background

As medical advancements continue and public health levels rise, increasing attention is being paid to the diagnosis and treatment of rare diseases. Given its large population, China's efforts in enhancing overall clinical abilities for rare disease diagnosis and treatment are crucial. However, young physicians still face significant challenges in their professional capabilities in this field.

Methods

Based on interviews with young physicians and medical education experts from rare disease diagnosis and research institutions, this study explored systematic approaches to cultivating and enhancing the expertise of young Chinese physicians in rare disease diagnosis and treatment, along with the necessary support systems.

Results

By thematic analysis, we identified six effective training models: (1) mentorship teaching, (2) specialized training systems, (3) integration of rare disease knowledge into standard curricula, (4) continuous education and career path planning, (5) application of information technology, and (6) institution-supported international collaboration. We also discussed critical implementation challenges such as resource intensity and interdisciplinary friction.

Conclusion

Based on these findings, we proposed a series of targeted strategies and recommendations. This study provided valuable experiences for young physicians in clinical and research institutions nationwide, thereby improving the overall level of rare disease diagnosis and treatment.

背景:随着医学的不断进步和公共卫生水平的提高,人们越来越重视罕见病的诊断和治疗。鉴于人口众多,中国在提高罕见病诊断和治疗的整体临床能力方面的努力至关重要。然而,年轻医生在这一领域的专业能力方面仍然面临着重大挑战。方法:通过对来自罕见病诊断和研究机构的年轻医生和医学教育专家的访谈,探讨培养和提高中国年轻医生在罕见病诊断和治疗方面的专业知识的系统方法,以及必要的支持系统。结果:通过专题分析,我们确定了六种有效的培训模式:(1)导师制教学,(2)专业培训体系,(3)将罕见病知识纳入标准课程,(4)继续教育和职业道路规划,(5)信息技术应用,(6)机构支持的国际合作。我们还讨论了关键的实施挑战,如资源强度和跨学科摩擦。结论:基于这些发现,我们提出了一系列有针对性的策略和建议。本研究为全国临床和科研机构的年轻医师提供了宝贵的经验,从而提高了罕见病诊治的整体水平。
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引用次数: 0
Language Barriers in the Federal Republic of Somalia's Healthcare: Addressing Inclusivity for Minority Dialects 索马里联邦共和国医疗保健中的语言障碍:解决少数民族方言的包容性问题。
IF 3.3 Pub Date : 2025-12-07 DOI: 10.1002/hcs2.70043
Najib Isse Dirie, Mohamed Mustaf Ahmed
<p>The Federal Republic of Somalia, often perceived as linguistically homogeneous, is home to a rich tapestry of dialects and minority languages that reflect its diverse cultural heritage. While Somali is the official medium of communication, it is divided into two major dialects: Maxaa Tiri (spoken by approximately 60% of the population) and Maay (spoken by approximately 20% of the population) [<span>1</span>]. Minority languages such as Bravanese (also known as Chimwiini or Chimbalazi), Mushunguli, Benadiri Somali, and Kibajuni are spoken by smaller communities, particularly in the southern and coastal regions [<span>1</span>]. Despite the demographic linguistic diversity shown in Table 1, Maxaa Tiri holds institutional dominance, functioning as the primary dialect in healthcare delivery, official communication, and in documentation [<span>2</span>]. This dominance marginalizes Maay speakers and other minority languages, limiting their access to healthcare information and services [<span>2</span>]. Effective communication between healthcare providers and patients is essential for informed consent, accurate diagnosis, appropriate treatment, and patient safety [<span>3</span>]. However, language barriers prevent many minority‑language speakers from accessing these critical aspects of care.</p><p>Health campaigns and medical documentation are predominantly conducted in Maxaa Tiri, leaving minority language speakers unable to fully understand vital health information [<span>2, 4</span>]. Rural areas in the Federal Republic of Somalia are particularly vulnerable to the consequences of this linguistic exclusion. These regions often lack sufficient healthcare infrastructure and are home to many speakers of Maay and other minority dialects [<span>2, 4</span>]. In such areas, healthcare workers may not speak local dialects, leading to frequent miscommunication. Moreover, health information, whether disseminated via campaigns, posters, or mobile platforms, is almost exclusively provided in Maxaa Tiri. This renders it inaccessible to large rural populations in developing countries. Consequently, residents of these regions are less likely to engage with health services, contributing to lower vaccination rates, delays in seeking care and poorer health outcomes.</p><p>This disconnection likely contributes to poorer health outcomes in minority communities. Although specific statistical data quantifying these outcomes are currently unavailable for the Federal Republic of Somalia, studies from similar low-resource settings have consistently demonstrated that language barriers lead to decreased healthcare utilization, reduced adherence to medical instructions, and increased patient safety risk [<span>5, 6</span>]. This commentary analyzes the linguistic barriers faced by minority language speakers in accessing healthcare in the Federal Republic of Somalia. It explores solutions through inclusive policies, digital health platforms and global best practices. By ad
索马里联邦共和国在语言上通常被认为是同质的,但它拥有丰富多彩的方言和少数民族语言,反映了其多样化的文化遗产。虽然索马里语是官方交流媒介,但它分为两种主要方言:Maxaa Tiri(约60%的人口使用)和Maay(约20%的人口使用)[1]。少数民族语言,如布拉瓦尼斯语(也被称为Chimwiini或Chimbalazi)、Mushunguli语、Benadiri索马里语和Kibajuni语,被较小的社区使用,特别是在南部和沿海地区。尽管表1显示了人口统计学语言的多样性,但Maxaa Tiri语在制度上占据主导地位,在医疗保健服务、官方沟通和文件编制中发挥主要方言的作用。这种优势使说马来语和其他少数民族语言的人边缘化,限制了他们获得医疗保健信息和服务的机会。医疗保健提供者和患者之间的有效沟通对于知情同意、准确诊断、适当治疗和患者安全至关重要。然而,语言障碍阻碍了许多少数民族语言使用者获得这些关键方面的护理。保健运动和医疗文件主要在Maxaa Tiri进行,使少数民族语言使用者无法完全理解重要的健康信息[2,4]。索马里联邦共和国的农村地区特别容易受到这种语言排斥的影响。这些地区往往缺乏足够的医疗基础设施,并且是许多说马来语和其他少数民族方言的人的家园[2,4]。在这些地区,医护人员可能不会说当地方言,导致频繁的沟通不端。此外,无论是通过运动、海报还是移动平台传播的卫生信息,几乎都只在Maxaa Tiri提供。这使得发展中国家的大量农村人口无法获得它。因此,这些地区的居民不太可能参与卫生服务,从而导致疫苗接种率较低、求医延误和健康结果较差。这种脱节可能会导致少数族裔社区的健康状况较差。虽然索马里联邦共和国目前没有量化这些结果的具体统计数据,但来自类似资源匮乏环境的研究一致表明,语言障碍导致医疗保健利用率下降,对医疗指示的依从性降低,并增加了患者安全风险[5,6]。本评论分析了少数民族语言使用者在索马里联邦共和国获得医疗保健服务时面临的语言障碍。它通过包容性政策、数字卫生平台和全球最佳做法探索解决方案。通过应对这些挑战,索马里联邦共和国可以更接近于为所有公民实现公平的医疗保健,并实现全民健康覆盖的目标。为了更好地了解这些挑战的性质,必须首先检查索马里联邦共和国复杂的语言环境及其与机构保健做法的相互作用。如表1所示,索马里联邦共和国展现了丰富多彩的语言多样性,各地区都有方言,如Maxaa Tiri、Maay和各种少数民族语言。然而,医疗机构在其官方实践中主要支持Maxaa Tiri。这种语言的排他性使得少数民族语言使用者很难与医疗服务提供者沟通或理解医疗建议。少数民族语言的分布,特别是在南部和沿海地区,突出了在不同语言地区提供公平医疗保健的复杂性。来自这些社区的患者往往由于害怕沟通不畅或虐待而避免寻求治疗。这种排斥导致边缘群体的健康结果更差,并扩大了索马里联邦共和国医疗保健系统内的不公平现象。语言障碍严重阻碍了索马里联邦共和国医疗保健系统治疗期间的知情同意程序和有效沟通。知情同意要求患者在给予批准之前充分了解医疗程序的性质、风险和益处。然而,大多数同意表格都是用Maxaa Tiri语言编写的,这使得少数民族语言使用者无法完全理解其中的内容。这种缺乏理解破坏了自主等伦理原则,并使患者和提供者都面临潜在风险。例如,由于语言障碍,患者可能在不了解潜在并发症或替代治疗的情况下,在不知情的情况下同意手术。 正如联合国所强调的那样,2024年索马里联邦共和国全民健康覆盖日强调了解决这些障碍的重要性。该活动强调需要有包容性的医疗保健系统,以满足不同语言社区的需求。利用戏剧和视觉意象等创新方法已被证明是提高识字或语言能力有限的人群对健康问题认识的有效工具[b]。这些方法可以通过以可获取和引人入胜的方式传递重要的卫生信息来弥合沟通差距。沟通方面的挑战超出了同意书的范围,还涉及到治疗过程中的互动。不能有效描述症状或不能理解医生指示的患者有被误诊或护理不当的风险。这些问题在紧急情况下尤其严重,因为及时沟通至关重要。为了应对这些挑战,必须在医疗机构雇用训练有素的口译员或双语工作人员。视觉辅助工具或图片同意书也可以帮助识字率低的人群更有效地理解关键信息。数字保健平台已成为索马里联邦共和国,特别是物质基础设施有限的地区应对保健挑战的有希望的工具。Baano和SomDoctor等平台引入了远程医疗服务,允许患者远程咨询提供者[13,14]。然而,这些平台主要迎合说马萨提里语的人,不包括那些用马来语或其他少数民族语言交流的人。尽管远程保健平台扩大了农村地区获得医疗咨询的机会,但缺乏多语言支持限制了其包容性。通过短信或录音传播的保健信息通常只以Maxaa Tiri语提供,使少数民族语言使用者无法充分受益于这些服务[10]。尽管存在这些限制,数字健康平台为弥合语言差距提供了重要机会。将多语言支持工具纳入现有远程保健系统可确保更广泛的可及性。人工智能驱动的翻译技术可以促进不同语言的患者和提供者之间的实时交流b[15]。通过允许用户与使用口语而不是书面文本的平台进行交互,基于语音的界面可以进一步提高低识字率人群的可访问性。通过将这些创新融入数字卫生平台,索马里联邦共和国可以创建更具包容性的系统,满足所有语言群体的需求,同时在全国范围内扩大获得高质量医疗服务的机会。为有效弥合语言差异,索马里联邦共和国可以采用创新解决方案,包括与多语言聊天机器人和数字口译培训平台相结合的移动保健应用程序。这些数字创新有助于根据少数民族社区的特定语言需求定制医疗保健服务,增强包容性和可及性。索马里联邦共和国的《临时宪法》承认马萨提里语和马埃语都是官方方言,但在医疗保健等关键部门缺乏强制性的语言包容性框架。这一政策差距对少数民族语言使用者的影响尤为严重,他们在获得主要为说Maxaa Tiri语的人设计的服务时面临系统性障碍[1,2,4]。一些国家提供了可转移的经验。南非国家卫生部语言政策(2023年)要求每个设施使用所有11种官方语言和南非手语进行交流,建立了合规问责机制。坦桑尼亚2024年社区卫生工作者课程包括基本口译和手语的强制性培训,将语言支持扩展到护理第一线。印度的Tele-MANAS全国心理健康求助热线于2022年开通,目前每天已经用20种印度语言处理了数千个电话,这表明多语言远程医疗如何能够覆盖语言多样化的农村人口。尼泊尔的《国家卫生传播政策》要求,所有全国卫生信息在传播之前都要用多种当地语言编写,确保没有任何社区被排除在重要信息之外。这些例子表明索马里联邦共和国可以采用的成功战略;索马里联邦共和国必须制定一项与全民健康覆盖目标相一致的语言包容性国家政策。公共保健设施必须提供马萨提里语和马伊语两种语言的服务,并在必要时为少数民族语言提供额外支持。将同意书、医疗记录和公共卫生材料翻译成多种方言可确保更广泛的可访问性。 像加拿大这样的国家实施了联邦资助的翻译项目,支持多种语言,大大减少了与语言相关的医疗保健差距。同样,印度有效地利用多语言远程医疗服务和当地定制的移动保健应用程序,在语言多样化的农村地区扩大医疗保健服务。虽然没有关于索马里联邦共和国的具体比较数据,但这些例子表明索马里联邦共和国可以采用成功的战略。还应制定一项国家方案,培训能流利使用少数民
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引用次数: 0
The First Clinical Renal Xenotransplantation Study (EXPAND): Evaluating Safety, Function, and Zoonotic Risks 第一项临床异种肾移植研究(EXPAND):评估安全性、功能和人畜共患风险。
IF 3.3 Pub Date : 2025-12-04 DOI: 10.1002/hcs2.70044
Björn Nashan
<p>On November 3, 2025, United Therapeutics Corporation (Nasdaq: UTHR) announced the first clinical xenotransplantation within its EXPAND study, involving transplantation of the UKidney into a patient with end-stage renal disease (ESRD) at New York University (NYU) Langone Health. The UKidney is a genetically engineered porcine kidney incorporating 10 gene modifications—6 human gene insertions to enhance immunologic compatibility and 4 porcine gene knockouts to minimize rejection risk and control graft growth [<span>1</span>]. In the context of the first xenotransplantation studies, “EXPAND” refers to the US Food and Drug Administration (FDA) “expanded access” program, often colloquially known as compassionate use. This program provides a pathway for seriously ill patients who have no other treatment options to receive an investigational medical device, in this case, a genetically modified pig heart, outside of a traditional clinical trial.</p><p>This announcement arrived just in time, since the last recipient, a 67-year-old male recipient at Massachusetts General Hospital, underwent removal of a genetically modified porcine kidney 9 months post-transplant due to progressive graft dysfunction in October 2025. The patient survived 271 days, representing the longest reported survival following a pig-to-human kidney xenotransplantation. Previous recipients experienced early graft loss or rejection. The case demonstrates extended graft viability and provides valuable clinical insight into the long-term outcomes of renal xenotransplantation [<span>2</span>].</p><p>The EXPAND study (NCT06878560) is a multicenter, open-label, interventional clinical trial sponsored by United Therapeutics Corporation. The study represents the first regulated clinical xenotransplantation program evaluating the <i>UKidney</i>, a 10-gene–edited porcine kidney in patients with ESRD who are ineligible for or unlikely to receive a human donor kidney within 5 years. The first xenotransplantation under this protocol was successfully performed at NYU Langone Health on November 3, 2025 [<span>3, 4</span>].</p><p>The <i>UKidney</i> is derived from a genetically engineered pig designed to enhance immunological compatibility and control organ growth. The genome modification includes six human gene insertions (knock-ins) that promote immune tolerance, regulate coagulation, and protect against complement-mediated injury, as well as four porcine gene deletions (knockouts) that remove carbohydrate epitopes responsible for hyperacute rejection and prevent excessive graft growth (Table 1) [<span>5</span>].</p><p>The primary objective of EXPAND is to evaluate the safety, tolerability, and functional performance of the xenograft at 24 weeks post-transplantation. Primary endpoints include patient and graft survival, while secondary endpoints assess glomerular filtration rate, proteinuria, and the incidence of xenograft rejection, infection, or other adverse events. Long-term follow-up will mo
2025年11月3日,联合治疗公司(纳斯达克股票代码:UTHR)宣布其EXPAND研究中的首个临床异种移植,涉及将ukkidney移植到纽约大学Langone Health的终末期肾病(ESRD)患者体内。UKidney是一种基因工程猪肾脏,包含10个基因修饰- 6个人类基因插入以增强免疫相容性,4个猪基因敲除以减少排斥风险并控制移植物生长bb0。在第一次异种移植研究的背景下,“EXPAND”指的是美国食品和药物管理局(FDA)的“扩大使用”计划,通常俗称为同情使用。这个项目为那些没有其他治疗选择的重病患者提供了一条途径,让他们在传统的临床试验之外接受一种实验性医疗设备,在这种情况下,是一种转基因猪心脏。这一消息来得很及时,因为上一位受体是马萨诸塞州总医院(Massachusetts General Hospital)的一名67岁男性受体,他在移植后9个月因移植物功能障碍进行性恶化,于2025年10月接受了转基因猪肾移植手术。患者存活了271天,是猪-人异种肾移植后最长的存活记录。先前的受者经历了早期移植物丢失或排斥反应。该病例证明了移植物生存能力的延长,并为肾脏异种移植的长期结果提供了有价值的临床见解。EXPAND研究(NCT06878560)是一项多中心、开放标签、介入性临床试验,由联合治疗公司(United Therapeutics Corporation)赞助。该研究代表了第一个评估UKidney的规范临床异种移植项目,UKidney是一种10基因编辑的猪肾,用于不符合条件或不太可能在5年内接受人类供体肾脏的ESRD患者。该方案下的首例异种移植于2025年11月3日在NYU Langone Health成功完成[3,4]。UKidney来源于一种基因工程猪,旨在增强免疫相容性和控制器官生长。基因组修饰包括6个人类基因插入(敲入),促进免疫耐受,调节凝血,防止补体介导的损伤,以及4个猪基因缺失(敲除),去除负责超急性排斥反应和防止移植物过度生长的碳水化合物表位(表1)[5]。EXPAND的主要目的是评估移植后24周异种移植物的安全性、耐受性和功能表现。主要终点包括患者和移植物的生存,而次要终点评估肾小球滤过率、蛋白尿、异种移植物排斥反应、感染或其他不良事件的发生率。长期随访将监测移植物功能的持久性、免疫适应性和潜在的人畜共患风险(表2)。该试验为1/2/3期研究,初始队列为6名接受异种移植的美国中心,随后计划扩大到约50名参与者,等待有利的安全性审查。EXPAND的数据预计将为生物制剂许可申请(BLA)的监管策略提供信息,并为临床异种肾移植bbb的标准化安全性和有效性框架的发展做出贡献。由于主要的免疫障碍——即超急性和急性排斥反应——现在在很大程度上基于先前的经验得到控制,目前的研究工作已经转向评估移植物的功能表现,特别是肾小球功能。一个关键的挑战可能是蛋白尿,因为调节补体介导的免疫反应的治疗性单克隆抗体可以通过过滤而丢失,这是以前在非人灵长类动物(NHP)模型中观察到的现象[7]。另一个关键焦点是人畜共患病原体的潜在传播。虽然NHP研究尚未证实猪内源性逆转录病毒的传播,但猪巨细胞病毒(pCMV)仍然是异种移植bb0中一个特别关注的问题。虽然pCMV不被认为会感染人类或NHPs,但在cmv阳性供体猪的移植组织中,在强烈的受体免疫抑制下,病毒复制可以发生。在受感染的异种肾移植受者中检测到pCMV复制,并且通常与移植物细胞早期核营养不良有关,提示在早期移植物功能障碍和排斥反应中起作用。值得注意的是,第一位异种心脏移植受者死于与pCMV感染相关的并发症,因为不能排除pCMV阳性器官引发了人类免疫反应[9,10]。 猪和人的正常生理参数差异很大,其中一些差异对异种肾脏移植具有潜在的临床意义,现在将在临床研究中进行评估。虽然电解质如钠、钾和碳酸氢盐的差异很小,但血红蛋白、磷酸盐和白蛋白水平存在显著差异。猪的血红蛋白降低可能影响移植后的促红细胞生成素(EPO)调节,而血清磷酸盐升高可能通过改变甲状旁腺激素、维生素D和成纤维细胞生长因子23信号来破坏骨和矿物质代谢。当暴露于较高的人白蛋白水平时,猪体内白蛋白浓度降低可能影响肾小球滤过动力学。尽管治疗措施可以解决其中的一些差异,但猪肾素和人血管紧张素原之间缺乏相互作用是一个重要的生理障碍。NHP研究报告了低血容量、低血压和无组织学排斥反应的一过性肾功能障碍,可能是由于肾素-血管紧张素-醛固酮系统活性受损或肾脏对抗利尿激素的反应性改变。此外,移植后贫血可能是由于猪EPO对宿主红细胞生成的刺激不足造成的,这使得跨物种功能整合的挑战更加复杂。EXPAND研究预计将产生第一个关于基因工程肾脏异种移植物的可靠人类数据,确定其在人类受体中维持代谢和血流动力学稳定性的能力。它还将澄清未解决的问题,如蛋白质损失、pCMV激活、跨物种激素和肾脏调节。其结果可能会影响未来的免疫学方案、生物安全标准和伦理框架——将异种移植定位为解决全球器官短缺的潜在长期解决方案。此外,这项研究的最终目的是解决现代医学中最紧迫的挑战之一——全球缺乏供终末期器官衰竭患者使用的器官。虽然肾移植受益于透析等替代方案,但等待心脏、肝脏或肺移植的患者没有类似的维持生命的治疗方法。通过将异种移植从实验性、同情性使用干预措施推进到结构化的临床试验框架,EXPAND研究代表了跨多学科开发可持续、可扩展的移植器官来源的关键一步[10,12 -17]。此外,该试验通过建立伦理和科学管理的异种移植研究模型,有助于弥合临床前可行性和临床实施之间的差距。它通过专业共识、监管监督和标准化临床方案引入严格的监督,确保科学完整性和患者安全。同样重要的是,它将公众参与作为一个核心要素——承认社会的理解和接受将是使异种移植合法化的关键,在未来,异种移植是一种可行的、挽救生命的治疗选择[18-20]。Björn纳山:概念化,方法论,写作-审查和编辑,写作-原稿,验证。作者没有什么可报道的。作者没有什么可报道的。Björn纳山教授是卫生保健科学编辑委员会的成员。为了尽量减少偏倚,他被排除在所有与接受这篇文章发表相关的编辑决策之外。作者没有什么可报道的。
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引用次数: 0
Prevalence and Potential Risk Predictors of Undernutrition Among Under-Five Children in Island Areas of Bangladesh 孟加拉国岛屿地区五岁以下儿童营养不良的患病率和潜在风险预测因素。
IF 3.3 Pub Date : 2025-12-04 DOI: 10.1002/hcs2.70041
Md. Abdul Aziz, Mohammad Mozibul Haque, Afia Nawar, Kazi Nazira Sharmin, Md. Altaf Hossain, Suvanker Saha

Background

Undernutrition poses a major threat for the growth and development of children in remote island regions of Bangladesh.

Methods

This study investigated the prevalence and risk predictors of undernutrition among children under five in the island regions of Bangladesh. A cross-sectional study was conducted in 13 unions across two islands, with a random sample of 549 children.

Results

Descriptive analyses showed that underweight (Z-score < −2), wasting (Z-score < −2), and stunting (Z-score < −2) were prevalent, with rates of 36.80%, 24.60%, and 47.20%, respectively. Significant predictors of underweight included a history of diarrhea (AOR = 2.24, p < 0.001), acute respiratory infection (ARI) (AOR = 1.84, p < 0.01), anemic caregivers (AOR = 1.52, p < 0.05), and belonging to day labor families (AOR = 0.29, p < 0.01). Childhood wasting was significantly associated with partial vaccination (AOR = 2.84, p < 0.001), large family size (AOR = 1.79, p < 0.05), higher birth order (AOR = 0.58, p < 0.05), diarrhea (AOR = 3.09, p < 0.001), anemic mothers (AOR = 1.89, p < 0.05), primary (AOR = 3.35, p < 0.05) and secondary (AOR = 4.11, p < 0.01) maternal education, and fathers working abroad (AOR = 0.42, p < 0.05) or as daily laborers (AOR = 0.17, p < 0.001). Stunting was more common among children with partial vaccination, diarrhea, and ARI, and less common among those with a history of fever or those from day laborer families.

Conclusion

Overall, undernutrition among children in the island areas of Bangladesh is influenced by multiple factors, necessitating a multisectoral approach to improve their nutritional status.

背景:营养不良对孟加拉国偏远岛屿地区儿童的生长发育构成重大威胁。方法:本研究调查了孟加拉国岛屿地区五岁以下儿童营养不良的患病率和风险预测因素。在两个岛屿的13个工会中进行了一项横断面研究,随机抽样了549名儿童。结果:描述性分析显示体重不足(Z-score Z-score Z-score pp pp pp pp pp p结论:总体而言,孟加拉国岛屿地区儿童营养不良受到多种因素的影响,需要采取多部门方法来改善他们的营养状况。
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引用次数: 0
Integrating Traditional Medicine to Improve the Care of Persistent Physical Symptom 结合传统医学改善顽固性躯体症状的护理。
IF 3.3 Pub Date : 2025-12-02 DOI: 10.1002/hcs2.70045
Huai-Yu Wang, Ji Wang, Qi Wang

Persistent physical symptom (PPS) is a common condition in sub-healthy population and patients with chronic disease, and significantly influences the quality of life. Many PPS cannot be explained by any known disease, and thereby are attributed to socio-psychological reasons and treated by psychological interventions, such as cognitive behavior treatment. However, it is not ideal to rationalize and manage the PPS lack of pathophysiological explanation relying on psychological approaches. The entrenched disease-centered biomedical mode limits the perception of PPS. Traditional medicine is a unique methodology of medicine independent from biomedical mode. Traditional Chinese medicine (TCM), achieved knowledge of health and disease from extensive observation and developed theoretical framework based on ancient mathematics using the principles of ancient naive materialism and dialectical materialism, has amassed extensive experience in symptom management. Particularly, the system of body constitution in TCM serves a reference model of evidence-based integration of traditional and modern medicine in healthcare, and offers a promising approach for managing PPS. Nine types of body constitution were identified and validated through a series of scientific research. Individuals with a specific type of body constitution tend to present a corresponding cluster of symptoms, physical signs, disease susceptibility and prognosis. Adjustment of unhealthy constitution helps the symptom control and disease management. Standardized protocol of body constitution classification was established as an industry standard, and that of body constitution adjustment was compiled as clinical guidelines for quality control. Taken together, such evidence-based integration of traditional medicine with modern medicine provides new avenues for managing PPS effectively.

持续性躯体症状(PPS)是亚健康人群和慢性疾病患者的常见病,对生活质量有重要影响。许多PPS不能用任何已知的疾病来解释,因此归因于社会心理原因,并通过心理干预,如认知行为治疗来治疗。然而,缺乏病理生理解释,依靠心理学方法来合理化和管理PPS是不理想的。根深蒂固的以疾病为中心的生物医学模式限制了PPS的认知。传统医学是一种独立于生物医学模式之外的独特的医学方法论。中医从广泛的观察中获得了对健康和疾病的认识,并运用古代朴素唯物主义和辩证唯物主义的原理,建立了以古代数学为基础的理论框架,积累了丰富的症状管理经验。特别是中医体质系统,为中医循证结合传统与现代医学的医疗保健提供了参考模式,为PPS的管理提供了一条有前景的途径。通过一系列的科学研究,确定并验证了九种体质类型。具有特定体质类型的个体往往会出现相应的症状、体征、疾病易感性和预后。调整不健康体质有助于症状控制和疾病管理。制定体质分类标准化方案作为行业标准,编制体质调整方案作为临床质量控制指南。总之,这种基于证据的传统医学与现代医学的结合为有效管理PPS提供了新的途径。
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引用次数: 0
Research on Cancer Prediction Based on Feature Optimization and Multimodal Fusion 基于特征优化和多模态融合的癌症预测研究。
IF 3.3 Pub Date : 2025-12-01 DOI: 10.1002/hcs2.70040
Jiawei Xu, Guodong Bao, Hansen Chen, Yifan Zhao, Mengqiang Yu, Jiqiang Shang, Yanxuan Luo, Hongbo Ge, Weiqi Hu, Wenhua Zhang, Xiangyi Zan, Zhixuan Yu, Minjie Ma, Xiong Cao, Menghao Guo, Chenxi Shi, Pengfei Cao, Lin Cheng

Background

Current lung cancer initial diagnosis relies on experienced doctors combining imaging and biological indicators, but uneven medical resource distribution in China leads to delayed early diagnosis, affecting prognosis. Existing methods struggle with large-scale screening, multitracking, and over-reliance on single-modality data, ignoring the potential of multisource complementary information. Key technical challenges—effective data collection, multimodal feature extraction/fusion, and AI model construction—limit clinical application. Thus, exploring AI, new sensors, and existing data for efficient, fast, accurate, and radiation-free preliminary diagnosis is crucial for timely treatment and improved outcomes.

Methods

This study collected hematological data, and used fiber-optic vibration sensors and audio sensors to capture heterogeneous signals of patients' lung respiration. Fiber-optic respiratory frequency, audio-respiratory rhythm, and hematological leukocyte-related features were extracted, optimized as multimodal inputs. The SCCA-LMF fusion method generated fusion samples, which were input into an improved stacking ensemble learning model (including SVM, XGBoost, etc.) for binary classification.

Results

The experiment included 360 actual samples (lung cancer: nonlung cancer = 3.6:1) with complete data of 55–65-year-old males and females. Predictive accuracy, sensitivity, specificity, and F1 score reached 97.70%, 95.75%, 99.64%, and 99.64%, respectively, outperforming existing independent LMF and TFN methods. This model effectively integrates respiratory vibration, audio signals, and routine blood tests. A multimodal feature grading fusion strategy was designed for 3D data analysis to comprehensively understand patient health and enhance prediction capabilities. All data and results are reproducible.

Conclusion

This study demonstrates the method's potential for lung cancer preliminary identification, bridging medicine and engineering to improve healthcare outcomes.

背景:目前肺癌的早期诊断依赖于经验丰富的医生结合影像学和生物学指标,但国内医疗资源分布不均导致早期诊断延迟,影响预后。现有的方法与大规模筛选、多重跟踪和过度依赖单模态数据作斗争,忽视了多源互补信息的潜力。关键技术挑战——有效的数据收集、多模态特征提取/融合和人工智能模型构建——限制了临床应用。因此,探索人工智能、新型传感器和现有数据,以实现高效、快速、准确和无辐射的初步诊断,对于及时治疗和改善预后至关重要。方法:收集血液学数据,采用光纤振动传感器和音频传感器采集患者肺呼吸的异质性信号。提取光纤呼吸频率、音频呼吸节律和血液学白细胞相关特征,并优化为多模态输入。SCCA-LMF融合方法生成融合样本,将融合样本输入改进的叠加集成学习模型(包括SVM、XGBoost等)进行二值分类。结果:实验纳入实际样本360例(肺癌:非肺癌= 3.6:1),数据完整,年龄55-65岁,男女均有。预测准确率、灵敏度、特异性和F1评分分别达到97.70%、95.75%、99.64%和99.64%,优于现有的独立LMF和TFN方法。该模型有效地集成了呼吸振动、音频信号和常规血液检测。设计了一种多模态特征分级融合策略,用于三维数据分析,全面了解患者健康状况,增强预测能力。所有数据和结果均可重复。结论:本研究证明了该方法在肺癌初步鉴定、衔接医学和工程以改善医疗保健结果方面的潜力。
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引用次数: 0
Goalie Phenomenon: Unveiling Hidden Health Conditions in Young Athletes 守门员现象:揭示年轻运动员隐藏的健康状况。
IF 3.3 Pub Date : 2025-11-11 DOI: 10.1002/hcs2.70039
Jaber H. Jaradat, Rawan Hamamreh, Abdulqadir J. Nashwan

Jaradat et al. (2025) first describe the goalie phenomenon in youth sports in which children with undiagnosed asthma gravitate toward less physically demanding positions, such as goalkeepers, to avoid exercise-induced respiratory symptoms like breathlessness, wheezing, or coughing. This compensatory behavior may inadvertently mask underlying health conditions, underscoring the importance of clinical vigilance and early diagnostic assessment in pediatric athletes

Jaradat等人(2025)首先描述了青少年体育运动中的守门员现象,在这种现象中,患有未确诊哮喘的儿童倾向于选择对体力要求较低的位置,如守门员,以避免运动引起的呼吸系统症状,如呼吸困难、喘息或咳嗽。这种代偿行为可能无意中掩盖了潜在的健康状况,强调临床警惕和儿科运动员早期诊断评估的重要性。
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引用次数: 0
“Walls Around Cells”—Food and Drug Administration's Recent Decoupling Policies Fragment Open Science and Undermine Global Health “细胞周围的墙”——美国食品和药物管理局最近的脱钩政策破坏了开放科学,损害了全球健康
IF 3.3 Pub Date : 2025-10-16 DOI: 10.1002/hcs2.70038
Liangbin Zhou, Ye Yuan

The recent decision of the US Food and Drug Administration (FDA) to halt new clinical trials involving the transfer of US patient cells for processing in designated countries, prominently including China, frames vital biomedical collaboration through an adversarial geopolitical lens. While data security and patient consent are paramount, this sweeping measure risks stifling innovation in critical fields like genetic engineering and cell therapy, disproportionately impacting patients with rare and complex diseases. The FDA's new policy overlooks China's established regulatory frameworks for biomedical ethics and data security, disregards the tangible benefits of past and present Sino-US scientific collaboration, and ultimately undermines the global fight against shared health challenges of the 21st century. Prioritizing open, transparent, and equitable international scientific cooperation, underpinned by robust mutual standards, is not merely preferable—it is essential for human health.

On June 18, 2025, the Food and Drug Administration (FDA) announced an immediate halt on new clinical trials exporting live cells from US citizens to China and other designated “hostile countries” for genetic engineering or processing before reinfusion [1]. Citing concerns over inadequate patient consent regarding international transfer and potential misuse of sensitive genetic data, this action leverages recent US data security rules and executive orders aimed at countering perceived foreign threats. While protecting patient rights and data is nonnegotiable, the FDA's approach, painting collaborative biomedical research with broad geopolitical suspicion, represents an alarming step towards scientific decoupling with profound negative consequences for global health progress.

Modern biomedical breakthroughs, particularly in complex fields like gene editing (e.g., CRISPR/Cas9 and base editing [2]), cell therapies (e.g., CAR-T [3] and stem cells), and new alternative methodologies (e.g., organoids and organs-on-chips [4-6]), are inherently global endeavors. Rare diseases, aggressive cancers, and novel infectious threats do not respect national borders. Tackling them requires pooling diverse patient populations, specialized expertise, advanced technological capabilities, and significant resources that no single nation possesses in abundance.

China has emerged as a major contributor in these fields during the past decade [7, 8]. Its significant investments in biotechnology infrastructure, large and genetically diverse patient populations, and growing cadre of highly skilled researchers offer invaluable assets. Numerous peer-reviewed studies published in leading journals, including The Lancet, The New England Journal of Medicine (NEJM), Nature, and Science, attest to the quality and impact of research emerging from Chinese universities or institutions [7-9]. Co

美国食品和药物管理局(FDA)最近决定停止涉及将美国患者细胞转移到指定国家(主要包括中国)进行处理的新临床试验,这一决定通过敌对的地缘政治视角构建了至关重要的生物医学合作。虽然数据安全和患者同意至关重要,但这一全面措施可能会扼杀基因工程和细胞治疗等关键领域的创新,对罕见和复杂疾病患者的影响尤为严重。FDA的新政策忽视了中国已建立的生物医学伦理和数据安全监管框架,无视过去和现在中美科学合作的切实利益,最终破坏了21世纪全球共同应对健康挑战的努力。优先考虑以强有力的相互标准为基础的公开、透明和公平的国际科学合作,这不仅是可取的,而且对人类健康至关重要。2025年6月18日,美国食品和药物管理局(FDA)宣布立即停止将美国公民的活细胞出口到中国和其他指定的“敌对国家”进行基因工程或处理的新临床试验。出于对国际转移患者不充分同意以及敏感基因数据可能被滥用的担忧,该行动利用了美国最近的数据安全规则和行政命令,旨在应对感知到的外国威胁。虽然保护患者权利和数据是不可协商的,但FDA的做法,将合作生物医学研究与广泛的地缘政治怀疑联系起来,代表了科学脱钩的一个令人震惊的步骤,对全球健康进步产生了深远的负面影响。现代生物医学的突破,特别是在复杂领域,如基因编辑(如CRISPR/Cas9和碱基编辑[2])、细胞治疗(如CAR-T[3]和干细胞)和新的替代方法(如类器官和芯片上器官[4-6]),本质上是全球性的努力。罕见疾病、侵袭性癌症和新型传染性威胁不分国界。解决这些问题需要汇集不同的患者群体、专业知识、先进的技术能力以及任何一个国家都无法拥有的大量资源。在过去十年中,中国已成为这些领域的主要贡献者[7,8]。它在生物技术基础设施、庞大且基因多样化的患者群体以及不断增长的高技能研究人员队伍方面的重大投资提供了宝贵的资产。《柳叶刀》、《新英格兰医学杂志》(NEJM)、《自然》和《科学》等领先期刊上发表的大量同行评议研究证明了中国大学或机构研究的质量和影响[7-9]。中美科学家之间的合作项目加速了药物发现,推进了对疾病机制的基本理解,并开发了有希望的治疗方法。停止对此类试验至关重要的生物样本和数据的流动,不仅会减慢美国的研究速度;它阻碍了全球对抗顽固性疾病的进展。FDA的行动含蓄地质疑了中国生物医学研究的伦理和安全标准。这种描述忽略了以下重要的发展。(1)监管框架不断完善:中国已经建立了完善的人类遗传资源和临床试验监管制度,而科研伦理的制度化和能力建设则持续了几十年。《生物安全法》和随后修订的《人类遗传资源管理条例》为监督提供了法律框架,包括对知情同意、数据隐私和数据保护的严格规定[10-14]。虽然实现是一个正在进行的过程,但框架是存在的,并且正在积极地执行。(2)遵守国际标准:在中国,领先的研究机构和医院严格执行国际伦理准则(如赫尔辛基宣言,CIOMS)。机构审查委员会(irb)或研究伦理委员会是有能力的。参与全球临床试验必须遵守国际良好临床规范(GCP)标准。(3)数据安全措施:对数据安全的担忧在全球范围内是合理的。然而,参与高级别国际合作的中国实验室通常采用先进的数据加密、安全存储解决方案和与西方机构相当的访问控制。在合作研究背景下,认为敏感数据本质上不太安全或更容易“被外国政府滥用”的说法需要具体证据,而不是笼统的地缘政治标签。 虽然FDA的政策是为了防范外国威胁,但它的明确禁止与中国的《个人信息保护法》和《生物安全法》形成鲜明对比,后者为国际数据交换建立了有条件的途径。PIPL(2021年生效)明确保护在中国境内处理的所有自然人数据(国内公民或外国人),这与欧盟相关法规基本一致,要求在明确同意的情况下进行合法、透明和必要的处理(第二章第13-14条)。至关重要的是,跨境传输需要:(1)通过中国网信办(CAC)对“重要”数据的安全评估;(二)经认可的机构认证;或者(3)与执行PIPL标准的海外接收者签订具有约束力的合同(第三章第38-40条)。中国个人信息保护法的根本立法目的不仅在于保护个人信息,而且在于促进个人信息的负责任使用,寻求保护与利用之间的最佳平衡。虽然严格,但这一框架允许在程序保障下进行转移,不像FDA的地缘政治否决权。《生物安全法(2024)》和《HGR条例》通过多层次审查进一步规范了基因数据,要求批准外国合作,但没有完全禁止它们[10-14]。因此,尽管美国政策制定者可能会援引中国的HGR限制作为对等理由,但区别在于它们的意图和机制。中国的法律通过明确的程序(如安全审查、合同)将风险管理准入写入法律,而FDA的政策是全面禁止,没有类似的合规或上诉途径。这种分歧凸显了一种实质性的不平衡:中国的框架虽然繁重,但能在相互监督下实现合作;FDA的做法建立了一个基于国籍的绝对障碍,而不是基于特定项目的风险。fda强调的主要问题是,在特定的美国豁免条款下,国际转移的患者同意不足,这表明美国在以前的框架下监管监督和企业透明度的失败,而不是中国研究伦理的内在缺陷。解决这个问题需要修正美国的同意程序并确保合作伙伴遵守,而不是切断与整个国家科学界的联系。美国食品药品监督管理局(FDA)的暂停,打着保护的幌子,带来了实质性的负面影响。首先,它会延迟病人的治疗。放慢或停止有希望的临床试验直接影响患者,特别是那些患有罕见疾病或晚期癌症的患者,他们几乎没有选择。中国的专业知识或独特的患者群体对于推进这些特定疗法至关重要。拒绝提供可能挽救美国人和全球公民生命的治疗。此外,这将扼杀创新。科学的进步有赖于思想、数据和技术的相互融合。将美国的研究与中国等重要创新中心隔离开来,阻碍了基因工程等快速发展领域所需的快速迭代和验证。它有可能创造出并行的、效率较低的科学生态系统。它还将阻碍美国中小型生物技术公司的经济增长,这些公司往往是新疗法的先驱,经常依赖国际合作伙伴进行具有成本效益的专门加工或获得特定患者群体。生物技术部门在全球伙伴关系中蓬勃发展。然而,FDA的这一行动造成了巨大的财务和运营负担,可能会推动海外创新或完全停止有前途的项目。更重要的是,这将导致信任的侵蚀。给合作伙伴贴上“敌对”的标签是基于国籍,而不是基于具体的、已证实的违规行为,这损害了科学合作所必需的相互尊重的基础。它助长了猜疑,破坏了几十年来富有成效的交流所建立起来的善意。最后但并非最不重要的一点是,它将在一定程度上导致全球领导力真空。退出国际合作将让出为新兴生物技术制定全球伦理和技术标准的领导地位。保护患者数据和确保道德严谨性是普遍的义务。然而,实现这些目标需要合作,而不是孤立。双方同意的、可核查的保障措施至关重要。美国、中国和其他领先的科学国家必须加强外交努力,为跨境生物医学研究建立明确、互惠的框架。这包括:(1)统一的同意标准:制定国际公认的模板,确保明确、全面的患者同意,涵盖数据和样本转移、存储和使用的所有方面。
{"title":"“Walls Around Cells”—Food and Drug Administration's Recent Decoupling Policies Fragment Open Science and Undermine Global Health","authors":"Liangbin Zhou,&nbsp;Ye Yuan","doi":"10.1002/hcs2.70038","DOIUrl":"https://doi.org/10.1002/hcs2.70038","url":null,"abstract":"<p>The recent decision of the US Food and Drug Administration (FDA) to halt new clinical trials involving the transfer of US patient cells for processing in designated countries, prominently including China, frames vital biomedical collaboration through an adversarial geopolitical lens. While data security and patient consent are paramount, this sweeping measure risks stifling innovation in critical fields like genetic engineering and cell therapy, disproportionately impacting patients with rare and complex diseases. The FDA's new policy overlooks China's established regulatory frameworks for biomedical ethics and data security, disregards the tangible benefits of past and present Sino-US scientific collaboration, and ultimately undermines the global fight against shared health challenges of the 21st century. Prioritizing open, transparent, and equitable international scientific cooperation, underpinned by robust mutual standards, is not merely preferable—it is essential for human health.</p><p>On June 18, 2025, the Food and Drug Administration (FDA) announced an immediate halt on new clinical trials exporting live cells from US citizens to China and other designated “hostile countries” for genetic engineering or processing before reinfusion [<span>1</span>]. Citing concerns over inadequate patient consent regarding international transfer and potential misuse of sensitive genetic data, this action leverages recent US data security rules and executive orders aimed at countering perceived foreign threats. While protecting patient rights and data is nonnegotiable, the FDA's approach, painting collaborative biomedical research with broad geopolitical suspicion, represents an alarming step towards scientific decoupling with profound negative consequences for global health progress.</p><p>Modern biomedical breakthroughs, particularly in complex fields like gene editing (e.g., CRISPR/Cas9 and base editing [<span>2</span>]), cell therapies (e.g., CAR-T [<span>3</span>] and stem cells), and new alternative methodologies (e.g., organoids and organs-on-chips [<span>4-6</span>]), are inherently global endeavors. Rare diseases, aggressive cancers, and novel infectious threats do not respect national borders. Tackling them requires pooling diverse patient populations, specialized expertise, advanced technological capabilities, and significant resources that no single nation possesses in abundance.</p><p>China has emerged as a major contributor in these fields during the past decade [<span>7, 8</span>]. Its significant investments in biotechnology infrastructure, large and genetically diverse patient populations, and growing cadre of highly skilled researchers offer invaluable assets. Numerous peer-reviewed studies published in leading journals, including <i>The Lancet</i>, The New England Journal of Medicine (NEJM), <i>Nature, and Science</i>, attest to the quality and impact of research emerging from Chinese universities or institutions [<span>7-9</span>]. Co","PeriodicalId":100601,"journal":{"name":"Health Care Science","volume":"4 5","pages":"355-358"},"PeriodicalIF":3.3,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/hcs2.70038","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145398961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Lung Xenotransplantation Advances in the Context of Clinical Pandora's Box—Positioned Amid Innovations in Heart, Kidney, and Liver Xenografts 在心脏、肾脏和肝脏异种移植创新的背景下,临床潘多拉盒子中的肺异种移植进展
IF 3.3 Pub Date : 2025-10-09 DOI: 10.1002/hcs2.70036
Björn Nashan

The milestone reported by He et al.—demonstrating pig-to-human lung xenotransplantation in a brain-dead recipient—is a seminal moment in organ xenografting. It extends the horizons of xenotransplantation beyond the breakthroughs achieved in porcine heart and kidney grafts and aligns with the emergent clinical data on porcine liver applications [1].

Pioneering porcine heart transplants into terminal human recipients demonstrated that genetic engineering and immunosuppression could transiently forestall immune rejection [2, 3], though the patients finally did not survive for a number of reasons related to infection. Likewise, porcine kidney grafts functioned for several days post-transplant in brain-dead human models [4]. Out of the four clinical cases transplanted so far, only one is reported to still function [5].

Recent forays into porcine liver xenotransplantation mark a new frontier. At Anhui Medical University, surgeons successfully performed a heterotopic auxiliary transplant of a gene-edited pig liver into a living human liver cancer patient (2024) [6]; the graft produced bile and demonstrated function in vivo without acute rejection. Similarly, at Xijing Hospital, a genetically modified porcine liver was implanted into a brain-dead patient and maintained function for 10 days [7, 8]. These short-term successes, while preliminary, emphasize the growing momentum in xenotransplant research [9, 10].

He et al. used lungs from donors lacking α‑Gal, Neu5Gc, and Sda antigens, alongside human complement regulators like CD46 and CD55 [1]. These modifications mirror those used in liver and renal models and underscore the importance of extensive glyco-immunological tuning [10]. The Anhui auxiliary liver case similarly employed 10-gene-edited pigs with multiple human transgenes to temper immune activation [6].

Primary graft dysfunction (PGD) remains a leading challenge in lung transplantation due to the organ's delicate microvascular network. He et al. reported stable early lung function post-transplant, though longer-term studies remain necessary [1]. In the liver context, thrombocytopenia and coagulopathy are prominent, driven by porcine vWF and cross-species incompatibility. Strategies integrating human thrombomodulin and complement inhibitors have partially mitigated this in preclinical models, but effective durability remains elusive [10].

Anti-CD40 monoclonal antibody use in He et al.'s protocol aligns with emerging preferences for targeted costimulation blockade in xenografts. This contrasts with earlier reliance on anti-CD154, which was associated with thrombosis [11, 12]. These strategies echo liver xenograft protocols, which have begun using tacrolimus, steroids, and B-cell depletion with preliminary success and no acute rejection in the reporte

He等人报道的里程碑——在脑死亡受者身上展示了猪到人的肺异种移植——是器官异种移植的开创性时刻。它扩展了异种移植的视野,超越了在猪心脏和肾脏移植方面取得的突破,并与猪肝应用的新兴临床数据保持一致。猪心脏移植的先驱性表明,基因工程和免疫抑制可以暂时预防免疫排斥[2,3],尽管患者最终因感染相关的一些原因而无法存活。同样地,猪肾移植在脑死亡的人类模型中也能维持数天的功能。到目前为止,在4例临床移植病例中,只有1例报告仍具有bb0功能。最近对猪肝异种移植的尝试标志着一个新的前沿。在安徽医科大学,外科医生成功地将基因编辑的猪肝移植到活的人类肝癌患者体内(2024年)。移植物在体内产生胆汁并显示出功能,无急性排斥反应。同样,在西京医院,将转基因猪肝植入脑死亡患者体内,其功能维持了10天[7,8]。这些短期的成功,虽然是初步的,但强调了异种移植研究的增长势头[9,10]。他等人使用了缺乏α - Gal、Neu5Gc和Sda抗原的供体肺,以及人类补体调节因子如CD46和CD55[1]。这些修饰反映了肝脏和肾脏模型中使用的修饰,并强调了广泛的糖免疫调节[10]的重要性。安徽辅助肝病例同样使用带有多种人类转基因的10基因编辑猪来调节免疫激活[6]。原发性移植物功能障碍(PGD)仍然是肺移植的主要挑战,由于器官的微血管网络的微妙。他等人报道了移植后早期肺功能稳定,但仍需要长期研究。在肝脏方面,血小板减少和凝血功能障碍是突出的,由猪vWF和跨物种不相容驱动。在临床前模型中,整合人血栓调节素和补体抑制剂的策略部分缓解了这种情况,但有效的持久性仍然难以捉摸。在He等人的方案中使用抗cd40单克隆抗体与异种移植物中靶向共刺激阻断的新兴偏好相一致。这与早期对抗cd154的依赖形成对比,后者与血栓形成有关[11,12]。这些策略与异种肝移植方案相呼应,异种肝移植方案已经开始使用他克莫司、类固醇和b细胞消耗,在报道的中国辅助和全尺寸肝移植病例中取得了初步成功,没有出现急性排斥反应[6,7]。他等人在人类环境下的猪肺异种移植是一个深刻的突破,与肝脏、心脏和肾脏异种移植的平行进展产生共鸣[1- 3,5,6]。总的来说,这些发展证实了猪器官在临床移植中日益增长的合理性——尽管需要经过严格的、逐步的验证[8,14 -16]。通往临床应用的道路必须将免疫生物学、器官特异性挑战和伦理保障结合起来。尽管如此,临床应用打开的潘多拉盒子必须用科学审慎来调和。Björn纳山:概念化,方法论,写作-审查和编辑,写作-原稿,验证。作者没有什么可报道的。作者没有什么可报道的。Björn纳山教授是卫生保健科学编辑委员会的成员。为了尽量减少偏倚,他被排除在所有与接受这篇文章发表相关的编辑决策之外。
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引用次数: 0
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