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Medical devices for professional use: What assessment, what funding? 专业医疗设备:什么评估,什么资助?
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-12-14 DOI: 10.1016/j.therap.2025.10.006
Valéry-Pierre Riche, Laure de Place, Xavier Armoiry, Dorothée Camus, Cécile Charle-Maachi, Mikael Deslandes, Christian Espagno, Jerome Fabiano, Line Farah, Mathieu Grajoszex, Erin Johns, Anne Josseran, Adrien Michaud, Louis Potel, Peggy Rematier, Thomas Riquier, Vincent Vercamer, Lou Verrier, Eric Vicaut, Isabelle Durand-Zaleski

Medical devices for professional use professional use medical device (DMUPs) are playing an increasingly important role in healthcare systems, driven by the rise of digital technologies. They encompass a wide range of equipment, from robotic surgery to diagnostic software solutions. There is no specific definition for DMUP, which complicates their integration into financing channels. Since years 2010s, two main dynamics have accelerated their spread: on the one hand, technological innovation (robotics, artificial intelligence, remote monitoring, connected objects) improving precision, efficiency, and quality of care; on the other hand, growing pressure on healthcare systems linked to an aging population and medical demographics. In France and Europe, regulatory authorities recognize their potential, while highlighting the difficulties of integrating them into traditional reimbursement frameworks. The French model, centered on the list of reimbursable products and services (LPPR), is ill-suited to DMUPs, particularly heavy equipment and digital medical devices. These are financed through grants or integrated into hospital rates, without any real systematic evaluation. European Regulation (EU) 2017/745 has strengthened clinical requirements, while experiments such as ETAPES have paved the way for innovative financing. Nevertheless, the evaluation of DMUPs remains hampered by the difficulty of demonstrating their clinical value and the insufficient consideration of their organizational impact. In response to these challenges, new approaches are emerging value-based models, broadening evaluation criteria to include organizational gains, and increased use of real-world data. In this context, the Giens 2025 Workshops devoted a round table to the evaluation and financing of DMUPs, in order to propose recommendations tailored to the needs of healthcare, the health system, and manufacturers.

在数字技术兴起的推动下,专业医疗设备(DMUPs)在医疗保健系统中发挥着越来越重要的作用。它们涵盖了范围广泛的设备,从机器人手术到诊断软件解决方案。DMUP没有具体的定义,这使得它们融入融资渠道变得复杂。自2010年以来,两大动力加速了它们的传播:一方面,技术创新(机器人、人工智能、远程监控、物联网)提高了护理的精度、效率和质量;另一方面,与人口老龄化和医疗人口统计有关的医疗保健系统压力越来越大。在法国和欧洲,管理当局认识到它们的潜力,同时强调将它们纳入传统报销框架的困难。法国模式以可报销产品和服务清单(LPPR)为中心,不适合dmup,特别是重型设备和数字医疗设备。这些费用通过赠款或纳入医院费率,没有任何真正的系统评估。欧洲法规(EU) 2017/745加强了临床要求,而ETAPES等实验为创新融资铺平了道路。然而,DMUPs的评估仍然受到展示其临床价值的困难和对其组织影响考虑不足的阻碍。为了应对这些挑战,新的方法正在出现基于价值的模型,扩大评估标准以包括组织收益,并增加对真实世界数据的使用。在此背景下,Giens 2025研讨会专门举行了一次圆桌会议,讨论DMUPs的评估和融资问题,以便根据医疗保健、卫生系统和制造商的需求提出建议。
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引用次数: 0
Accélérer les recrutements dans les essais cliniques : un défi stratégique. 加快临床试验的招募:一个战略挑战。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-12-13 DOI: 10.1016/j.therap.2025.11.009
Dominique Deplanque, Ariane Galaup, Christine Trillou, Philippe Barthélemy, Arnaud Bayle, Lionel Da Cruz, Erik Domain, Michael Duruisseaux, Cécile Fouret, Laetitia Gambotti, Cécile Girault, Damien Gonthier, Aurélie Guérin, Antoine Hommais, Jean-Sébastien Hulot, Dorothée Ko, Marie Lang, Vincent Laugel, Bruno Laviolle, Christophe Le Tourneau, Julie Oheix, Tabassome Simon, Jérémy Skryspski
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引用次数: 0
[Edible cannabis: Safe food? About a series of 5 cases]. 食用大麻:安全食品?共5例]。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-29 DOI: 10.1016/j.therap.2025.11.007
Sandra Thorigné, Véronique Ferey, Elodie Saussereau, Sabrina Cherki, Reynald Le Boisselier
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引用次数: 0
Chemsex, drugs and consequences: A short review. 化学,药物和后果:一个简短的回顾。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-25 DOI: 10.1016/j.therap.2025.11.006
Diane Le Bouëdec, Romain Pelletier, François Bénézit, Raphaël Pangui, Isabelle Morel, Thomas Gicquel

Chemsex refers to the intentional use of psychoactive substances to enhance sexual expériences. It often involves prolonged sexual sessions, multiple partners, and the use of drugs such as GHB, synthetic cathinones, and erectile dysfunction medications. Prevalence estimates vary widely across studies, ranging from 9 to 21% in Europe, reflecting heterogeneity in definitions and populations studied. This practice can be associated to serious health risks, including substance addiction, psychiatric disorders, and increased rates of sexually transmitted infections (STIs), notably HIV and hepatitis C. Intravenous drug use during sex ("slamming") carries particularly high risks. Despite its initial emergence in men who have sex with men (MSM) communities, chemsex is also reported among heterosexual and transgender populations. Effective responses require non-judgmental, multidisciplinary support, combining harm reduction, mental health care, and STI prevention. Healthcare professionals must be trained to recognize and address chemsex-related issues. Further research is needed to better define the phenomenon and inform public health strategies. This article provides a brief review of the characteristics, epidemiology, and potential addictive, infectious, and psychological consequences of chemsex.

化学性爱指的是故意使用精神活性物质来增强性体验。它通常包括长时间的性行为,多个伴侣,以及使用药物,如GHB,合成卡西酮和勃起功能障碍药物。不同研究的患病率估计值差异很大,在欧洲从9%到21%不等,反映了定义和研究人群的异质性。这种做法可能与严重的健康风险有关,包括药物成瘾、精神障碍和性传播感染(性病),特别是艾滋病毒和丙型肝炎的发病率增加,特别是在性行为期间静脉注射毒品(“砰”)的风险特别高。尽管它最初出现在男男性行为(MSM)群体中,但据报道,在异性恋和变性人群中也有化学性行为。有效的应对需要非评判性的多学科支持,结合减少伤害、精神卫生保健和性传播感染预防。医疗保健专业人员必须接受培训,以识别和解决与化学品有关的问题。需要进一步研究以更好地定义这一现象并为公共卫生战略提供信息。本文简要回顾了化学性的特点、流行病学以及潜在的成瘾性、传染性和心理后果。
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引用次数: 0
Are there gender differences in adverse drug reactions to levodopa? A real-world safety comparison in the global pharmacovigilance database. 左旋多巴的不良反应是否存在性别差异?全球药物警戒数据库中真实世界的安全性比较。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-20 DOI: 10.1016/j.therap.2025.11.004
Jean-Louis Montastruc

Background: Gender differences were reported in Parkinson's disease as well as in drug effects in general.

Objective: The study was performed to investigate putative gender differences in levodopa-related adverse drug reactions (ADRs).

Methods: Using Vigibase®, the global pharmacovigilance database, all ADRs reports with levodopa between 01/01/2000 and 31/12/2024 in adults were included. The main levodopa (motor and non-motor) ADRs were compared between women and men. Results are presented as reporting odds ratios (ROR) with their 95% confidence interval.

Results: Among 2887 ADRs with levodopa, the reporting risk in women was significantly higher for dyskinesia (ROR=1.31 [1.00-1.71]), dystonia (1.41 [1.03-1.93]), nausea-vomiting (2.08 [1.45-2.99]), and significantly lower for hypersexuality (0.10 [0.02-0.42]), dopamine dysregulation syndrome (0.32 [0.14-0.73]) pathological gambling (0.33 [0.14-0.76]) and all ADRs in general (0.48 [0.45-0.52]), with no difference for other ADRs.

Conclusion: This study shows gender-related differences for not only motor (dyskinesia, dystonia) but also non-motor levodopa ADRs.

背景:性别差异在帕金森氏病以及一般的药物效应中都有报道。目的:探讨左旋多巴相关药物不良反应(adr)的性别差异。方法:使用全球药物警戒数据库Vigibase®,纳入2000年1月1日至2024年12月31日成人左旋多巴的所有不良反应报告。比较男女左旋多巴主要不良反应(运动性和非运动性)。结果以报告优势比(ROR)表示,其95%置信区间。结果:在2887例左旋多巴不良反应中,女性运动障碍(ROR=1.31[1.00-1.71])、肌张力障碍(ROR= 1.41[1.03-1.93])、恶心呕吐(ROR= 2.08[1.45-2.99])的报告风险显著高于女性,性欲亢进(ROR= 0.10[0.02-0.42])、多巴胺失调综合征(ROR= 0.32[0.14-0.73])、病理性赌博(ROR= 0.33[0.14-0.76])和所有不良反应(ROR= 0.48[0.45-0.52])的报告风险显著低于女性,其他不良反应的报告风险无差异。结论:本研究不仅显示了运动障碍(运动障碍、肌张力障碍)和非运动左旋多巴不良反应的性别差异。
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引用次数: 0
Cerebral air embolism induced by polidocanol foam sclerotherapy in chronic venous disease: A case report. 多元醇泡沫硬化治疗慢性静脉疾病致脑空气栓塞1例。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-20 DOI: 10.1016/j.therap.2025.11.005
Gwendal Dubois, Charles Khouri, Christophe Seinturier, Sophie Blaise
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引用次数: 0
Hydroxyurea-induced severe interstitial pneumonitis: A case report. 羟基脲所致严重间质性肺炎1例。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-20 DOI: 10.1016/j.therap.2025.11.003
Omar Masrour, Roya Nili Asgari, Anne Charpentier, Olivier Sanchez, Jean Pastre
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引用次数: 0
Mixtures and dilutions of commercial solutions for oral drops: What happens in these cocktails? 商业口服滴剂溶液的混合物和稀释剂:在这些鸡尾酒中发生了什么?
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-17 DOI: 10.1016/j.therap.2025.11.002
Caroline Castera-Ducros, Romain Paoli-Lombardo, Ikram Zaddam, Cyril Fersing, Charleric Bornet, Patrice Vanelle, Pascal Rathelot, Christophe Curti

Background: Physicochemical incompatibilities of parenteral drugs are frequently studied and reported, but are rarely documented for liquid oral drugs. However, in clinical practices, nurses may perform mixtures of several liquid oral formulations. Although such practices are not recommended, there is a lack of scientific evidence to support this statement.

Objective: We aimed to study potential incompatibilities of the most dispensed commercial liquid oral formulations in a psychiatric ward.

Methods: First, a bibliographic analysis was performed. Then, 1:1 mixtures of one commercial liquid specialty and tap water and 1:1:1 mixtures of two commercial formulations and water were realized and controlled both visually and analytically. When a precipitate was formed, the mixture was considered incompatible.

Results: A table of oral liquid drug incompatibilities was compiled, and the need for pharmaceutical expertise on this subject was discussed.

Conclusion: This work is the first report of oral liquid drugs' physicochemical incompatibilities and can lead to an improvement in clinical practices.

背景:肠外药物的物理化学不相容性经常被研究和报道,但很少有关于口服液体药物的文献记录。然而,在临床实践中,护士可能会使用几种液体口服配方的混合物。虽然不推荐这样的做法,但缺乏科学证据来支持这一说法。目的:我们旨在研究在精神科病房配药最多的商业口服液制剂的潜在不相容性。方法:首先进行文献分析。然后,实现了一种商品专用液体与自来水1:1的混合,以及两种商品配方与水1:1:1的混合,并进行了可视化和分析控制。当沉淀形成时,混合物被认为是不相容的。结果:编制了口服液药物不配伍表,并讨论了对这一课题的药学专业知识的需求。结论:本文首次报道了口服液类药物的理化不相容性,对临床应用具有一定的指导意义。
{"title":"Mixtures and dilutions of commercial solutions for oral drops: What happens in these cocktails?","authors":"Caroline Castera-Ducros, Romain Paoli-Lombardo, Ikram Zaddam, Cyril Fersing, Charleric Bornet, Patrice Vanelle, Pascal Rathelot, Christophe Curti","doi":"10.1016/j.therap.2025.11.002","DOIUrl":"https://doi.org/10.1016/j.therap.2025.11.002","url":null,"abstract":"<p><strong>Background: </strong>Physicochemical incompatibilities of parenteral drugs are frequently studied and reported, but are rarely documented for liquid oral drugs. However, in clinical practices, nurses may perform mixtures of several liquid oral formulations. Although such practices are not recommended, there is a lack of scientific evidence to support this statement.</p><p><strong>Objective: </strong>We aimed to study potential incompatibilities of the most dispensed commercial liquid oral formulations in a psychiatric ward.</p><p><strong>Methods: </strong>First, a bibliographic analysis was performed. Then, 1:1 mixtures of one commercial liquid specialty and tap water and 1:1:1 mixtures of two commercial formulations and water were realized and controlled both visually and analytically. When a precipitate was formed, the mixture was considered incompatible.</p><p><strong>Results: </strong>A table of oral liquid drug incompatibilities was compiled, and the need for pharmaceutical expertise on this subject was discussed.</p><p><strong>Conclusion: </strong>This work is the first report of oral liquid drugs' physicochemical incompatibilities and can lead to an improvement in clinical practices.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145669233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Intranasal abuse of buspirone: Cases serie. 丁螺环酮鼻内滥用:案例系列。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-07 DOI: 10.1016/j.therap.2025.11.001
Quentin Tourdot, Margot Lestienne, Paul Mathieu, Thomas Risdorfer De Issdentzi, Coralie Bourzeix, Laura Jaubert, Hélène Donnadieu, Céline Eiden, Hélène Peyrière
{"title":"Intranasal abuse of buspirone: Cases serie.","authors":"Quentin Tourdot, Margot Lestienne, Paul Mathieu, Thomas Risdorfer De Issdentzi, Coralie Bourzeix, Laura Jaubert, Hélène Donnadieu, Céline Eiden, Hélène Peyrière","doi":"10.1016/j.therap.2025.11.001","DOIUrl":"https://doi.org/10.1016/j.therap.2025.11.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145565499","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Livre blanc de la pharmacologie biologique 生物药理学白皮书
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-01 DOI: 10.1016/j.therap.2025.10.002
Florian Lemaitre , Caroline Monchaud , Matthieu Grégoire , Romain Guilhaumou , Françoise Goirand , groupe de travail « Suivi thérapeutique pharmacologique et personnalisation des traitements de la Société française de pharmacologie et de thérapeutique »
En 2024, le groupe de travail « Suivi thérapeutique pharmacologique et personnalisation des traitements de la Société française de pharmacologie et de thérapeutique » a élaboré un livre blanc dont l’objectif est de présenter l’état des lieux de la sous-discipline de la pharmacologie biologique, de décrire les compétences attendues pour exercer le métier de pharmacologue biologiste, de définir le périmètre de l’activité professionnelle, d’identifier les forces et les points d’amélioration actuels de la sous-discipline dans l’objectif final de proposer les évolutions du métier de pharmacologue biologiste. Ce document se compose de plusieurs parties : un préambule visant à rappeler le panorama de la pharmacologie biologique en France ; un état des lieux rappelant ce qu’est un pharmacologue biologiste, ses missions, les forces et faiblesses de la profession et les pré-requis en termes de formation ; un référentiel de compétences du pharmacologue biologiste et enfin les perspectives et nouvelles missions du pharmacologue biologiste. Ce document a pour vocation de servir de référentiel, d’aider à définir la profession de pharmacologue biologiste et de structurer la discipline afin de pouvoir la faire évoluer vers une profession d’interface entre biologie et clinique.
In 2024, the therapeutic drug monitoring and treatment personalization working group of the Société française de pharmacologie et de thérapeutique (French Society of Pharmacology and Therapeutics) drew up a white paper, the aim of which is to present the current state of the biological pharmacology discipline, describe the skills required to exercise the profession, define the scope of professional activity, identify the discipline's current strengths and areas for improvement, with the ultimate aim of proposing changes to the profession of biological pharmacologist. This document is divided into several parts: a preamble outlining the panorama of biological pharmacology in France; a review of the current situation, outlining what a pharmacological biologist is, his or her missions, the strengths and weaknesses of the profession, and the prerequisites in terms of training; a reference framework of competencies for the pharmacological biologist; and, finally, the prospects and new missions of the pharmacological biologist. The purpose of this document is to serve as a term of reference, to help define the profession of pharmacological biologist, and to structure the discipline so that it can evolve into a profession at the interface between biology and the clinic.
2024年,工作组后续«药理治疗及个体化治疗的法国社会药理学与治疗学»起草了一份白皮书,其目标是现状介绍生物药理学的挑战性,期望为从事职业技能描述药理学家、生物学家大院界定职业活动,确定该亚学科当前的优势和改进点,最终目标是提出生物药理学专业的发展。该文件由几个部分组成:序言部分旨在回顾法国生物药理学的概况;概述生物药理学家是什么,他的任务,这个职业的优势和劣势,以及培训的先决条件;生物药理学家技能的参考,以及生物药理学家的观点和新任务。本文件的目的是作为一个参考点,帮助定义生物药理学专业,并组织该学科,使其发展成为生物学和临床之间的接口专业。2024 In the治疗药物监测和治疗,personalization working group of the法国社会药理学与治疗学》(French Society of Pharmacology Therapeutics) drew up the aim of which is to a white paper,此证the current state of the生物学科Pharmacology),描述the skills to演习为他的职业、define the scope of professional活动,查明the discipline’s current集中优势区for improvement,最终目标是对生物药理学专业提出改变。本文分为几个部分:初步概述了法国生物药理学的概况;对当前情况的回顾,概述药理学生物学家是什么,他或她的任务,专业的优势和劣势,以及培训方面的先决条件;药理生物学家的职权参考框架;最后,药理学生物学家的前景和新任务。本文的目的是作为一个参考术语,帮助定义药理学生物学家的职业,并构建这一学科,使其能够在生物学和临床之间的接口上发展成一个专业。
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引用次数: 0
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Therapie
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