Therapie最新文献

{"title":"The enhanced national pharmacovigilance system implemented for COVID-19 vaccines in France: A 2-year experience report","authors":"Samuel Crommelynck ,&nbsp;Aurélie Grandvuillemin ,&nbsp;Claire Ferard ,&nbsp;Céline Mounier ,&nbsp;Nathalie Gault ,&nbsp;Evelyne Pierron ,&nbsp;Baptiste Jacquot ,&nbsp;Tiphaine Vaillant ,&nbsp;Isabelle Parent du Chatelet ,&nbsp;Alexis Jacquet ,&nbsp;Francesco Salvo ,&nbsp;Martine Alt ,&nbsp;Haleh Bagheri ,&nbsp;Joëlle Micallef ,&nbsp;Antoine Pariente ,&nbsp;Sophie Gautier ,&nbsp;Marie-Blanche Valnet-Rabier ,&nbsp;Marina Atzenhoffer ,&nbsp;Marion Lepelley ,&nbsp;Judith Cottin ,&nbsp;Mehdi Benkebil","doi":"10.1016/j.therap.2024.11.002","DOIUrl":"10.1016/j.therap.2024.11.002","url":null,"abstract":"<div><div>In March 2020, World Health Organization recognized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emergence as a public health emergency of international concern. One of the major preventative measures developed against coronavirus disease 2019 (COVID-19) was vaccines. To monitor their use and safety of vaccines from the first utilization in humans during clinical development phases to implementation for the general population, an enhanced national pharmacovigilance system was enabled by the French National Agency for Medicines and Health Products Safety in collaboration with the 30 Regional Pharmacovigilance Centres. Here, we review the significant outcomes from a 2-year collaboration experience between the French National Agency for Medicines and Health Products Safety, the 30 Regional Pharmacovigilance Centres, disease-related experts and the pharmacovigilance and risk assessment committee at the European medicine agency. In France, until January 2023, over 155 million doses of COVID-19 vaccines were administrated, and 190,000 adverse events following immunizations (25% classified as serious) were analysed. Altogether 53 potential safety signals were reported to the Pharmacovigilance and Risk Assessment Committee at the European Medicine Agency by the French National Agency for Medicines and Health Products Safety: 13 were confirmed, 24 are still under investigation and 16 were not confirmed. The enhanced national PV system contributed actively better to define the safety profile of the newly developed vaccines, and the French National Agency for Medicines and Health Products Safety continues to monitor the benefit and risks of the COVID-19 vaccines.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 429-437"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786791","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}

{"title":"Pharmacodynamic interaction between ginger and antiplatelet drugs: A case report","authors":"Layal El Aridi ,&nbsp;Hélène Jantzem ,&nbsp;Corinne Guihard ,&nbsp;Myriam Marteil ,&nbsp;Greta Gourier","doi":"10.1016/j.therap.2025.02.004","DOIUrl":"10.1016/j.therap.2025.02.004","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 499-502"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531815","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}

{"title":"Photodistributed cutaneous vasculitis: An uncommon side effect for topical ketoprofen","authors":"Nadia Fetoui Ghariani ,&nbsp;Nour el Imene Ouni ,&nbsp;Sawssen Layouni ,&nbsp;Marwa Thabouti ,&nbsp;Haifa Mkhinini ,&nbsp;Maha Lahouel ,&nbsp;Badreddine Sriha ,&nbsp;Ben Salem C. ,&nbsp;Najet Ghariani ,&nbsp;Mohamed Denguezli","doi":"10.1016/j.therap.2025.01.003","DOIUrl":"10.1016/j.therap.2025.01.003","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 494-496"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143410854","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}

{"title":"Translation of the REMEDI[e]S (Review of potentially inappropriate MEDIcation pr[e]scribing in Seniors) explicit criteria into seminatural language for use in prescription support systems: A multidisciplinary consensus","authors":"Romane Freppel ,&nbsp;Anaïs Barbier ,&nbsp;Mathilde Dambrine ,&nbsp;Laurine Robert ,&nbsp;Chloé Rousselière ,&nbsp;Estel Cuneo ,&nbsp;Pascal Odou ,&nbsp;Sophie Gautier ,&nbsp;Jean-Baptiste Beuscart ,&nbsp;Marie-Laure Laroche ,&nbsp;Bertrand Décaudin","doi":"10.1016/j.therap.2024.09.002","DOIUrl":"10.1016/j.therap.2024.09.002","url":null,"abstract":"<div><h3>Background</h3><div>By recovering data in an ordered manner and at the right time, clinical decision support systems (CDSSs) are designed to help healthcare professionals make decisions that improve patient care.</div></div><div><h3>Objectives</h3><div>The aim of the present study was to translate the REMEDI[e]s tool's explicit criteria, France's first reference list of potentially inappropriate drugs for the elderly, into seminatural language, in order to implement these criteria as alert rules and then enable their computer coding in a CDSS.</div></div><div><h3>Methods</h3><div>This work was carried out at Lille University Hospital by a team of clinical pharmacists with expertise in the use of pharmaceutical decision support systems, in collaboration with the authors of the REMEDI[e]s tool. A total of 3 multi-professional consensus meetings were required to discuss the construction of each rule in seminatural language and the coding choices.</div></div><div><h3>Results</h3><div>All REMEDIES criteria (<em>n</em> <!-->=<!--> <!-->104) were translated into seminatural language. This study is the first to have translated the 104 REMEDI[e]s explicit criteria into seminatural language.</div></div><div><h3>Conclusions</h3><div>One of the study's strengths relates to the close collaboration between the authors of the REMEDI[e]s tool and experts in CDSS programming rules; this ensured the exactitude of the seminatural language translations and limited (mis)interpretations.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 477-493"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508626","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}

{"title":"Impact délétère d’un anti-inflammatoire non stéroïdien pris pour fièvre ou douleur aiguë en cas d’infection streptococcique","authors":"Annie-Pierre Jonville-Bera ,&nbsp;Joëlle Micallef","doi":"10.1016/j.therap.2025.02.012","DOIUrl":"10.1016/j.therap.2025.02.012","url":null,"abstract":"<div><div>Depuis plusieurs années, les centres régionaux de pharmacovigilance alertent sur le risque d’aggravation des infections bactériennes cutanées ou pulmonaires à streptocoques pyogènes ou à pneumocoques, après la prise d’anti-inflammatoires non stéroïdiens (AINS), notamment l’ibuprofène. Une nouvelle expertise présentée à l’Agence du médicament en 2024 a colligé en 4,5 ans, 216 cas d’infections bactériennes graves (162 avec ibuprofène, 54 avec kétoprofène) après la prise d’AINS pour fièvre ou douleur aiguë, soit environ 21 % des effets indésirables graves avec l’ibuprofène (8 % pour le kétoprofène). Les infections streptococciques étaient majoritaires pour l’ibuprofène (62 % des cas d’infection bactérienne graves ; 44 % pour le kétoprofène). Ces infections streptococciques étaient invasives (97 %), à type de sepsis sévère/choc toxinique, de pleuropneumopathie, de méningite/méningoencéphalite et de dermohypodermite nécrosante. Les études de pharmaco-épidémiologie suggèrent toute une association entre l’exposition à un AINS et une augmentation du risque de complications pleuropulmonaires avec une estimation du risque compris entre 1,8 et 8. Plusieurs données mécanistiques sont également en faveur d’un effet délétère spécifique sur la gravité des infections invasives streptococciques, par un effet propre, intrinsèque des AINS sur l’amplification de la diffusion des streptocoques (via la vimentine). Des études expérimentales, chez l’animal, démontrent également ce risque, même quand l’AINS est associé à un antibiotique. En conclusion, en présence d’une infection streptococcique, qu’elle soit diagnostiquée ou non, la prise d’un AINS pour fièvre ou douleur aiguë, même sur une courte durée, et même associée à un antibiotique est une pratique à risque. Elle favorise l’évolution vers une infection streptococcique plus grave, non seulement en retardant la prise en charge de l’infection, mais surtout en favorisant la dissémination du streptocoque. Dans la mesure où les infections invasives à <em>Streptococcus pyogenes</em> sont un réel problème de santé publique, tout facteur de risque potentiel d’aggravation doit être pris en compte.</div></div><div><div>For several years, regional pharmacovigilance centers have been warning about the risk of worsening bacterial skin or lung infections caused by <em>Streptococcus pyogenes</em> or <em>Pneumococcus</em> after taking non-steroidal anti-inflammatory drugs (NSAIDs), particularly ibuprofen. A new report submitted to the French Medicines Agency in 2024 documented 216 cases of serious bacterial infections (162 with ibuprofen, 54 with ketoprofen) over 4.5 years following the use of NSAIDs for fever or acute pain. This represents about 21% of serious adverse events with ibuprofen (8% with ketoprofen). Streptococcal infections were most common with ibuprofen (62% of serious bacterial infections; 44% with ketoprofen). These streptococcal infections were invasive (97%) and included severe sepsis/toxic shock, ple","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 424-428"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143670947","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}

{"title":"Impact d’une rupture de dronabinol sur une population de patients douloureux chroniques : étude observationnelle rétrospective","authors":"Salomé Winckel,&nbsp;Laurie Ferret,&nbsp;Laure Dujardin,&nbsp;Amélie Boursier","doi":"10.1016/j.therap.2024.12.010","DOIUrl":"10.1016/j.therap.2024.12.010","url":null,"abstract":"<div><h3>Objectif</h3><div>Une rupture d’approvisionnement en dronabinol a eu lieu entre décembre 2023 et février 2024 imposant aux patients douloureux chroniques d’interrompre ce traitement. Nous avons évalué l’impact de cette pénurie sur les patients de notre établissement.</div></div><div><h3>Méthodes</h3><div>Une étude observationnelle rétrospective a été menée auprès des patients traités par dronabinol. Les données recueillies comprenaient des données sociodémographiques, pharmacologiques et cliniques. L’intensité et la description de la douleur, l’intensité des autres dimensions de la douleur (humeur, relation aux autres…) et la qualité du sommeil ont été recueillis avant la rupture (posologie de dronabinol équilibrée, M0) et à la fin de la rupture (dronabinol arrêté depuis plusieurs semaines, M3). Le ressenti du patient de l’évolution de son état de santé a été recueilli à la fin de la rupture.</div></div><div><h3>Résultats</h3><div>Une dégradation de leur état de santé a été rapportée par 86 % des patients après 3 mois de rupture. L’intensité de la douleur et son interférence avec la vie quotidienne des patients a augmenté de façon significative. Le sommeil des patients s’est significativement dégradé. Le nombre de patients avec des douleurs permanentes a été multiplié par 5 (<em>n</em> <!-->=<!--> <!-->2 à M0 et <em>n</em> <!-->=<!--> <!-->10 à M3). Le nombre de patients avec plus de 20 crises douloureuses par 24<!--> <!-->heures a été multiplié par 2 (<em>n</em> <!-->=<!--> <!-->2 à M0 et <em>n</em> <!-->=<!--> <!-->4 à M3).</div></div><div><h3>Conclusion</h3><div>Bien que les données concernant l’efficacité du dronabinol soient aujourd’hui limitées, cette rupture d’approvisionnement a eu des conséquences cliniques négatives chez nos patients. Les pénuries de médicaments se multipliant ces dernières années, la commercialisation de nouvelles spécialités et donc la présence d’alternatives thérapeutiques pourrait permettre chez ces patients douloureux chroniques réfractaires, de diminuer l’impact clinique d’une éventuelle nouvelle rupture de dronabinol.</div></div><div><h3>Objective</h3><div>A supply shortage of dronabinol occurred between December 2023 and February 2024, forcing chronic pain patients to discontinue this treatment. We assessed the impact of this shortage on patients in our hospital.</div></div><div><h3>Method</h3><div>A retrospective observational study of patients treated with dronabinol was conducted. Collected data included socio-demographic, pharmacological and clinical data. Pain intensity and its interference, the intensity of other pain dimensions (mood, relationship with others, etc.) and quality of sleep were collected before discontinuation (dronabinol dosage balanced, M0) and at the end of discontinuation (dronabinol stopped for several weeks, M3). The patient's perception of his state of health evolution was collected at the end of the shortage.</div></div><div><h3>Results</h3><div>Health deterioration was repo","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 4","pages":"Pages 469-476"},"PeriodicalIF":1.8,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012200","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}

{"title":"[ISO 9001: 2015 certification of the clinical trial unit of a university hospital center].","authors":"Tristan Pillot, Anas Gahbiche, Xavier Duval, Vanessa Bloch, Aude Jacob","doi":"10.1016/j.therap.2025.06.004","DOIUrl":"https://doi.org/10.1016/j.therap.2025.06.004","url":null,"abstract":"<p><strong>Objectives: </strong>The field of clinical research is continuously developing in healthcare institutions in France. However, this development should not come at the expense of the quality of studies or the safety of patients involved in research projects. Describe the certification process of the pharmaceutical clinical trials unit of Lariboisière hospital-Fernand Widal's (unité pharmaceutique des essais cliniques de l'hôpital Lariboisière-Fernand Widal UPEC) quality management system according to the ISO 9001: 2015 standard for the continuous improvement of quality.</p><p><strong>Methods: </strong>This certification project, initiated by the medical-university department to which UPEC belongs, was led by a quality assurance officer, supported by a quality consultant, and carried out by the members of the UPEC team. An initial audit provided a status report, and a planning schedule structured the entire process by setting deadlines.</p><p><strong>Results: </strong>Obtained in September 2023, the certification for the pharmaceutical management of investigational products in our sector was achieved by identifying internal and external issues, interested parties, and the risks and opportunities related to UPEC's activities. Additionally, the development of relevant monitoring indicators allows for the evaluation of the quality systems management's (QMS) effectiveness. Finally, the prioritization of actions based on the conclusions of the initial audit report enabled effective progress, resulting in a QMS compliant with the ISO 9001: 2015 standard within 21 months.</p><p><strong>Conclusions: </strong>Thus, obtaining the certification represents a tremendous experience, the culmination of the substantial work provided by the entire team, and an external recognition that is beneficial for the development of the activity through future partnerships.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144699626","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}

{"title":"[Case report of a lethal voluntary drug intoxication with mirtazapine and venlafaxine complicated with a massive pharmacobezoar].","authors":"Romain Batton, Fabien Lamoureux, Marion Beuzelin, Jean-Philippe Rigaud, Antoine Marchalot","doi":"10.1016/j.therap.2025.06.005","DOIUrl":"https://doi.org/10.1016/j.therap.2025.06.005","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144650623","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}

{"title":"Preventing the risk of tuberculosis with teriflunomide: Is pre-treatment screening necessary?","authors":"Marlène Damin-Pernik, Emilie Mayer, Anne Dautriche, Laure Mazzola, Marie-Noelle Beyens, Elisabeth Botelho-Nevers","doi":"10.1016/j.therap.2025.06.003","DOIUrl":"https://doi.org/10.1016/j.therap.2025.06.003","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144601698","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}

{"title":"Rituximab-induced subcutaneous sarcoidosis in a patient with refractory pemphigus vulgaris.","authors":"Maha Lahouel, Yosr Yousfi, Amal Hamdi, Neila Fathallah, Sarra Saad, Badreddine Sriha, Najet Ghariani, Mohamed Denguezli","doi":"10.1016/j.therap.2025.06.002","DOIUrl":"https://doi.org/10.1016/j.therap.2025.06.002","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144708878","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}