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[CHALLENGE accepted! Exercise in oncology: from "Supportive Care" to "Effective Treatment"]. (接受挑战!肿瘤学中的运动:从“支持性护理”到“有效治疗”。
Q3 Medicine Pub Date : 2026-01-01 DOI: 10.1701/4631.46401
Aureliano Stingi, Giuseppe Aprile, Sara Aspromonte, Alice Avancini, Francesco Bettariga, Luigia Carapezza, Sara Compagni, Raffaele Giusti, Sara Pilotto, Marta Schirripa, Fotios Loupakis

Modern oncology faces the need to integrate high-level evidence, non-pharmacological interventions into care pathways. Among these, structured physical exercise is shifting from a simple "virtuous recommendation" to a treatment that concretely influences clinical outcomes. The phase III CHALLENGE trial, conducted on 889 patients with stage II-III colon cancer, demonstrated a 6.4% absolute increase in 5-year disease-free survival (DFS) (HR 0.72) and a 37% reduction in overall mortality (HR 0.63). Observational evidence further confirms benefits in breast, prostate, and lung cancers. This review summarizes the literature, analyzes barriers and implementation strategies (tele-exercise, dedicated professionals, hub-and-spoke models), and assesses psychological and economic impacts.

现代肿瘤学面临着将高水平证据、非药物干预纳入护理途径的需要。其中,有组织的体育锻炼正从一种简单的“良性推荐”转变为一种具体影响临床结果的治疗方法。在889例II-III期结肠癌患者中进行的III期CHALLENGE试验显示,5年无病生存期(DFS)绝对增加6.4% (HR 0.72),总死亡率降低37% (HR 0.63)。观察性证据进一步证实了对乳腺癌、前列腺癌和肺癌的益处。这篇综述总结了文献,分析了障碍和实施策略(远程训练,专门的专业人员,中心和辐模型),并评估了心理和经济影响。
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引用次数: 0
[Brexu-cel cell therapy and subsequent allogeneic hematopoietic stem cell transplantation in the treatment of late-relapse B-cell acute lymphoblastic leukemia]. [brexus细胞疗法和随后的异基因造血干细胞移植治疗晚期复发的b细胞急性淋巴细胞白血病]
Q3 Medicine Pub Date : 2026-01-01 DOI: 10.1701/4631.46412
Lucia Brunello

Here we report the case of a 39 years old patient who experienced a hematological relapse of B-cell acute lymphoblastic leukemia 23 months after completion of maintenance therapy. Relapse occurred two days after brexu-cel approval for reimbursement within the Italian National Health System. This favourable timing enabled the prompt apheresis for brexu-cel manufacturing, bridge therapy with inotuzumab ozogamicin and subsequently brexu-cel infusion. The patient achieved a complete molecular remission and thereafter performed an allogeneic stem cell transplantation. Currently, at 19 and 15 months after brexu-cel infusion and transplant, respectively, the patient presents sustained MRD negative remission with no graft-versus-host-disease evidence and a good quality of life.

在此,我们报告一例39岁的患者,在完成维持治疗23个月后b细胞急性淋巴细胞白血病血液学复发。复发发生在意大利国家卫生系统批准报销后两天。这一有利的时机使得brexus细胞制造的及时分离、用inotuzumab ozogamicin进行桥接治疗和随后的brexus细胞输注成为可能。患者达到了完全的分子缓解,此后进行了异体干细胞移植。目前,分别在brexus - cell输注和移植后19和15个月,患者出现持续的MRD阴性缓解,无移植物抗宿主病证据,生活质量良好。
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引用次数: 0
[CAR-T therapy in relapsed or refractory B-cell acute lymphoblastic leukemia: a new treatment paradigm]. CAR-T治疗复发或难治性b细胞急性淋巴细胞白血病:一种新的治疗模式。
Q3 Medicine Pub Date : 2026-01-01 DOI: 10.1701/4631.46414
Giovanni Grillo, Anna Mochi

The therapy of patients with acute lymphoblastic leukemia (ALL) in the latter has achieved significant progress by increasing the complete remission (CR) rate, re-binding allogeneic transplantation to patients with high-risk disease and/or not in MRD-negative CR. The flip side of these successes is the more difficult management for patients who are refractory to modern treatment regimens or who relapse. Historically, it was necessary to aim for a CR and consolidate the result with allogeneic transplantation, an option available only to young and fit patients. Introduction of CAR therapy T seems to undermine this dogma by allowing to offer a lasting therapeutic perspective even for elderly patients who do not obtain a clinical response with second line therapy.

急性淋巴细胞白血病(ALL)患者在后者的治疗已经取得了显著进展,通过增加完全缓解(CR)率,对高风险疾病和/或非mrd阴性CR的患者进行再结合异体移植,这些成功的另一面是对现代治疗方案难治性或复发的患者的管理更加困难。从历史上看,有必要以CR为目标,并通过同种异体移植巩固结果,这种选择仅适用于年轻和健康的患者。CAR - T疗法的引入似乎打破了这一教条,因为它甚至可以为那些在二线治疗中没有获得临床反应的老年患者提供持久的治疗前景。
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引用次数: 0
[Malignant Wound Assessment Tool-Clinical version: Italian translation and content and face validation for the assessment of malignant cutaneous wounds]. [恶性伤口评估工具-临床版:意大利语翻译及内容和面部验证恶性皮肤伤口评估。]
Q3 Medicine Pub Date : 2026-01-01 DOI: 10.1701/4631.46403
Gabriele Cremona, Fiorella Bersanetti, Francesca Costa, Maurizio Beretta, Martina Maserati, Patrizia Dorsi, Marina Bolzoni, Monica Muroni, Cinzia Merlini, Lorella Cappucciati, Marco Alfredo Arcidiacono, Gianluca Conte, Arianna Magon, Rosario Caruso, Matteo Altavilla, Luigi Cavanna

Introduction: Malignant fungating wounds (MFW) pose a significant clinical challenge, affecting patients' quality of life through debilitating symptoms such as pain, exudate, and odor. This study aimed to translate, adapt, and validate the Malignant Wound Assessment Tool-Clinical version (MWAT-C) to assess malignant fungating wounds in Italy.

Methods: The study followed a multi-phase methodological design, including a backward and forward translation process and evaluation of the Italian version by 18 healthcare experts. Face and content validity were assessed using a Likert scale to rate item relevance and clarity.

Results: The overall S-CVI value was 0.96, with I-CVI values ranging from 0.78 to 1.00. Experts considered items related to pain, odor, and exudate particularly relevant. Some items, such as patient perception of the wound, received lower ratings, highlighting challenges in self-assessment.

Conclusion: Adopting this tool could improve the quality of care, reduce variability in clinical practices, and facilitate a multidimensional approach. However, further studies are needed to evaluate the scale's inter-rater reliability and internal consistency.

恶性真菌性伤口(MFW)是一项重大的临床挑战,通过诸如疼痛、渗出和气味等衰弱症状影响患者的生活质量。本研究旨在翻译、改编和验证恶性伤口评估工具-临床版本(mwatt - c),以评估意大利的恶性真菌性伤口。方法:本研究采用多阶段方法学设计,包括向后和向前翻译过程,并由18名卫生保健专家对意大利语版本进行评估。使用李克特量表评估面部和内容效度,以评估项目的相关性和清晰度。结果:S-CVI值为0.96,I-CVI值为0.78 ~ 1.00。专家们认为与疼痛、气味和分泌物有关的项目尤其相关。一些项目,如患者对伤口的感知,得分较低,突出了自我评估的挑战。结论:采用该工具可以提高护理质量,减少临床实践的可变性,并促进多维方法。但量表的信度和内部一致性有待进一步研究。
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引用次数: 0
Dalla letteratura
2025 Dicembre.
从2025年12月起。
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1701/4619.46276
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引用次数: 0
“Il professore ebreo perseguitato due volte”. “犹太老师被迫害了两次。”
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1701/4619.46288
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引用次数: 0
Sotto la lente della valutazione d’impatto privacy: la ricerca clinica fra trasparenza e sfide regolatorie. 从影响评估的角度来看,隐私:透明度和监管挑战之间的临床研究。
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1701/4619.46279
Alessandra Piccolo, Veronica Franchina, Celeste Cagnazzo

In the context of clinical research, the Data Protection Impact Assessment (DPIA), as required by Article 35 of the GDPR 2016/679, is an essential tool to ensure the compliant and responsible processing of personal data, particularly health and genetic data. The adoption of the DPIA addresses the need to safeguard the fundamental rights and freedoms of data subjects in high-risk scenarios, such as multicenter studies and the use of innovative technologies. This article analyzes the ethical, regulatory, and organizational value of the DPIA in clinical trials, highlighting operational challenges such as lack of resources, insufficient training, interpretative ambiguities, and weak integration with ethics committees. A multidisciplinary approach is proposed that sees the DPIA not merely as a regulatory obligation but as a strategic lever to enhance transparency and quality in research. In conclusion, the importance of clarifying roles and responsibilities is emphasized, while promoting a culture of data protection from the earliest stages.

根据GDPR 2016/679第35条的要求,在临床研究背景下,数据保护影响评估(DPIA)是确保合规和负责任处理个人数据,特别是健康和遗传数据的重要工具。DPIA的通过解决了在高风险情况下保护数据主体的基本权利和自由的需要,例如多中心研究和创新技术的使用。本文分析了临床试验中DPIA的伦理、监管和组织价值,强调了操作上的挑战,如缺乏资源、培训不足、解释含糊,以及与伦理委员会的整合不力。提出了一种多学科方法,认为DPIA不仅是一种监管义务,而且是提高研究透明度和质量的战略杠杆。最后,强调澄清角色和责任的重要性,同时从最初阶段就促进数据保护文化。
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引用次数: 0
[Tafamidis between real-world evidence and registration trials: towards a price renegotiation with a view to sustainability and appropriateness]. [Tafamidis在真实世界证据和注册试验之间:走向可持续性和适当性的价格重新谈判]
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1701/4619.46281
Tiziano Lupi, Fiorenzo Santoleri, Maurizio Belfiglio

Introduction: The evolving epidemiological landscape of transthyretin amyloid cardiomyopathy (ATTR-CM), particularly in its wild-type form, highlights a progressive increase in diagnoses. This trend calls for a critical reflection on the economic sustainability of tafamidis treatment, given the expanding eligible patient population and the lack of price renegotiation.

Methods: A retrospective study was conducted on patients treated at an Asl (2023-2025). Persistence and adherence to the treatment were evaluated. A linear regression model estimated future incidence and economic impact.

Results: Among 17 patients, persistence was 58.82%, adherence (>80%) 100%. Incidence rose from 15.2 to 35.73 cases/million (2018-2025). The 5-year cost per patient exceeded € 815,000. Based on the ATTR-ACT trial NNT (7.46), 2.3 deaths may be prevented, though this benefit may be overestimated.

Discussion: The rising incidence was not followed by a price revision. Use in older, frail patients and the absence of dynamic pricing agreements raise questions about cost-effectiveness and equitable access.

导论:转甲状腺素淀粉样心肌病(atr - cm)的流行病学发展趋势,特别是其野生型,突出了诊断的逐步增加。鉴于符合条件的患者人数不断扩大和缺乏价格重新谈判,这一趋势要求对他法底斯治疗的经济可持续性进行批判性反思。方法:回顾性研究在Asl治疗的患者(2023-2025)。评估治疗的持续性和依从性。线性回归模型估计了未来的发病率和经济影响。结果:17例患者中,坚持率为58.82%,依从性(>)为100%。2018-2025年,发病率从15.2例/万上升到35.73例/万。每位患者的5年成本超过81.5万欧元。根据atr - act试验NNT(7.46),可以预防2.3例死亡,尽管这一益处可能被高估。讨论:发病率的上升并没有伴随着价格的调整。在老年人和体弱患者中使用,以及缺乏动态定价协议,引发了有关成本效益和公平获取的问题。
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引用次数: 0
Progetto MetaMind – Ausl Toscana sud est: studio preliminare sull’utilizzo della tecnologia digitale nei percorsi psicoterapeutici. MetaMind - Ausl tuscany东南项目:在心理治疗路径中使用数字技术的初步研究。
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1701/4619.46286
Luca Pianigiani, Crescenza Mazzaraco, Giulia Centini, Valentina Bruchi, Gabriele Cercaci, Luca Canestri, Sandro Limaj, Giuliana Galli, Antonio D'Urso, Elena Capitani, Roberto Turillazzi, Federico Taddeini, Maria Giovanna D'Amato
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引用次数: 0
[Right to food and health in prisons: managing Ramadan for incarcerated individuals of Islamic faith]. [监狱中的食物和健康权:管理被监禁的伊斯兰教徒的斋月。]
Q3 Medicine Pub Date : 2025-12-01 DOI: 10.1701/4619.46278
Sandro Libianchi, Assunta Giordano, Giuseppe Scuderi, Emanuela Falconi, Ornella Vagnozzi, Anna Luisa Giustiniani, Sandra Milani, Francesca Benedetta Felici, Davide Marino

Health status and nutrition are fundamental determinants of overall well-being among incarcerated populations, who constitute a particularly vulnerable group. The prison environment functions as a microcosm where the rights to health and adequate food must be safeguarded without compromise, given that detainees rely entirely on institutional provisions for their care and nourishment. The cultural specificity of immigrant inmates introduces particular needs, including adherence to dietary requirements during Ramadan for individuals of Islamic faith. This raises significant health and nutritional considerations. Prolonged fasting can pose serious health risks, especially for individuals with underlying conditions such as diabetes mellitus, requiring the use of long-acting pharmacological formulations to ensure therapeutic continuity. Furthermore, the adequacy of food - considering its type, timing of administration, and ritual aspects - represents a central component of the rights to health and cultural diversity, as food carries symbolic meanings beyond mere sustenance. The State, responsible for safeguarding the rights and well-being of detainees, must ensure that nutritional provisions are both nutritionally appropriate and culturally respectful. Food is not only a primary necessity but also an element of identity and psychological well-being: inadequate or culturally insensitive meals can negatively affect psycho-physical health, potentially contributing to self-harm and, in severe cases, suicide, which is unfortunately on the rise within Italian prisons. Implementing a more attentive and inclusive food system can therefore improve detainees' health outcomes and promote greater emotional and social stability within correctional facilities.

健康状况和营养是被监禁人口总体福祉的根本决定因素,他们是特别脆弱的群体。监狱环境是一个缩影,在这里,被拘留者完全依赖机构提供的照料和营养,必须毫不妥协地保障健康权和适足食物权。移民囚犯的文化特殊性带来了特殊的需求,包括伊斯兰教徒在斋月期间遵守饮食要求。这引起了重大的健康和营养问题。长时间禁食可能会造成严重的健康风险,特别是对于患有糖尿病等潜在疾病的个体,需要使用长效药理制剂来确保治疗的连续性。此外,食物充足——考虑到食物的种类、管理时间和仪式方面——是健康权和文化多样性的一个核心组成部分,因为食物不仅具有维持生计的象征意义。负责保障被拘留者权利和福利的国家必须确保提供的营养既营养适当又尊重文化。食物不仅是基本必需品,而且是身份和心理健康的一个因素:不适当或文化上不敏感的饮食会对身心健康产生负面影响,可能导致自残,在严重的情况下,自杀,不幸的是,自杀在意大利监狱中呈上升趋势。因此,实施一个更加细心和包容的食物系统可以改善被拘留者的健康结果,并促进惩教设施内更大的情绪和社会稳定。
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引用次数: 0
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Recenti progressi in medicina
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