Therapie最新文献

{"title":"Certification ISO 9001 : 2015 de l’ensemble des activités de recherche d’un centre hospitalier universitaire","authors":"Lina Mustapha ,&nbsp;Christine Lebel ,&nbsp;Sophie Boddaert ,&nbsp;Sandrine Castelain ,&nbsp;Gilles Duverlie ,&nbsp;Olivier Ganry ,&nbsp;Yves-Édouard Herpe ,&nbsp;Ségolène Lebreton ,&nbsp;Jean-Pierre Marolleau ,&nbsp;Henri Sevestre ,&nbsp;Sandrine Soriot-Thomas ,&nbsp;Riad Tebbakha ,&nbsp;Thierry Yzet ,&nbsp;Aude Sautier ,&nbsp;Jean-Luc Schmit","doi":"10.1016/j.therap.2022.12.008","DOIUrl":"https://doi.org/10.1016/j.therap.2022.12.008","url":null,"abstract":"<div><h3>Introduction</h3><p>En France, le nombre d’établissements hospitaliers impliqués dans la recherche clinique et engagés dans une démarche qualité est en augmentation. L’objectif de telles démarches est d’assurer la sécurité des patients impliqués dans les projets de recherche en améliorant la qualité.</p></div><div><h3>Objectif</h3><p>Le CHU d’Amiens a fait le choix de certifier selon le référentiel ISO 9001 : 2015 toutes ses activités de recherche clinique dans un même périmètre.</p></div><div><h3>Méthodes</h3><p>Une planification des actions a été établie et un responsable du <em>management</em> de la qualité a été nommé afin de piloter cette démarche.</p></div><div><h3>Résultats</h3><p>Les activités des cinq services de notre CHU certifiées conjointement en décembre 2019 sont : les activités de promotion interne et externe, la méthodologie et la surveillance des projets de recherche clinique de la Direction de la recherche clinique et de l’innovation (DRCI) ; l’aide à l’investigation des projets de recherche clinique du Centre de recherche clinique (CRC) ; la gestion du circuit des unités thérapeutiques impliquées dans la recherche clinique (à l’exclusion de la fabrication des médicaments) de l’Unité des essais cliniques (UEC) de la pharmacie à usage intérieur ; la conservation et la mise à disposition de ressources biologiques (tissus et fluides) à des fins de recherche en cancérologie de la Tumorothèque de Picardie ; la collecte, la réception, la préparation, le contrôle qualité, la conservation et la mise à disposition de ressources biologiques à des fins de recherche et dans le cadre d’activités légales et règlementaires et la prestation de stockage sécurisé du Centre de ressources biologiques déjà certifié ISO 9001 depuis 2004 et NF S96-900 : 2011 depuis 2009.</p></div><div><h3>Conclusions</h3><p>Le choix d’une démarche qualité commune a permis de réunir plus de 70 personnes de 5 services impliqués dans les projets de recherche clinique au sein d’un même certificat dans un objectif d’amélioration continue.</p></div><div><h3>Introduction</h3><p>In France, the number of hospitals involved in clinical research and committed to a quality approach is increasing. The objective of such approaches is to ensure the safety of patients involved in research projects by improving quality.</p></div><div><h3>Objective</h3><p>The University Hospital of Amiens has chosen to certify all its clinical research activities in the same scope according to the ISO 9001: 2015 standard.</p></div><div><h3>Methods</h3><p>Action planning has been established and a head of quality management has been appointed to oversee this process.</p></div><div><h3>Results</h3><p>The activities in the five departments of our university hospital jointly certified in December 2019, are: activities related to internal and external sponsors, as well as methodology and monitoring of clinical research projects conducted in the Clinical Research and Innovation Department (CRID); h","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90003360","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":"Follow-up of patients hospitalized for cocaine detoxification. Inpatient cocaine detoxification","authors":"Sophie Roy ,&nbsp;Céline Eiden ,&nbsp;Erika Nogue ,&nbsp;Marie-Christine Picot ,&nbsp;Hélène Donnadieu-Rigole ,&nbsp;Hélène Peyrière","doi":"10.1016/j.therap.2022.11.008","DOIUrl":"10.1016/j.therap.2022.11.008","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10346091","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":"Secukinumab-induced vitiligo: A new case report and review of the literature","authors":"Sana Bouzid ,&nbsp;Houda Hammami-Ghorbel ,&nbsp;Amal Chamli ,&nbsp;Imen Aounti ,&nbsp;Wiem Daly ,&nbsp;Samir Kochbati ,&nbsp;Samy Fenniche ,&nbsp;Anissa Zaouak","doi":"10.1016/j.therap.2022.12.004","DOIUrl":"10.1016/j.therap.2022.12.004","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10432001","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":"A case of acute psychosis triggered by anabolic steroid abuse (trenbolone)","authors":"Cyrine Bey ,&nbsp;Wafa Abdelghaffar ,&nbsp;Taieb Ach ,&nbsp;Nadia Haloui ,&nbsp;Mariem Inès Bouzid ,&nbsp;Rym Rafrafi","doi":"10.1016/j.therap.2023.04.001","DOIUrl":"10.1016/j.therap.2023.04.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9352472","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":"Autoimmune hepatitis following mRNA COVID-19 vaccine","authors":"Ahmed Zaiem ,&nbsp;Khouloud Ferchichi ,&nbsp;Ghozlane Lakhoua ,&nbsp;Widd Kaabi ,&nbsp;Imen Aouinti ,&nbsp;Sana Rebii Debbiche ,&nbsp;Sarrah Kastalli ,&nbsp;Lamia Kallel ,&nbsp;Ons Charfi ,&nbsp;Sihem El Aidli","doi":"10.1016/j.therap.2022.12.014","DOIUrl":"10.1016/j.therap.2022.12.014","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10231459","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":"Réalisation d’études pharmacoépidémiologiques à partir du système national des données de santé (SNDS) : application des recommandations dans la pratique","authors":"Sibylle de Germay ,&nbsp;Cécile Conte ,&nbsp;Joëlle Micallef ,&nbsp;Emilie Bouquet ,&nbsp;Laurent Chouchana ,&nbsp;Margaux Lafaurie ,&nbsp;Antoine Pariente ,&nbsp;au nom du groupe de pharmaco-épidémiologie de la Société Française de Pharmacologie et de Thérapeutique (SFPT)","doi":"10.1016/j.therap.2023.01.010","DOIUrl":"https://doi.org/10.1016/j.therap.2023.01.010","url":null,"abstract":"<div><p>The French health insurance data warehouse named SNDS is one of the largest medico-administrative in the world allowing for powerful pharmacoepidemiological studies, based on real-life data collected prospectively. In addition to the absolute necessity of a strong pharmacological rationale, recommendations have been thought to improve the quality of pharmacoepidemiological studies. These guidelines emphasize the importance of an accurate definition of the study population, outcome and exposure, especially for studies performed on medico-administrative databases. Compliance with certain guidelines, particularly those concerning the identification of a specific population or an outcome and the definition of risk periods or exposure periods, may be difficult when performing studies on the SNDS because of its structure and the nature of the data recorded. The objective of this article is to provide advice for the conduct of pharmacoepidemiological studies according to the recommendationswhen using the SNDS, given its specificities. The performing of reliable studies from this rich but complex data warehouse requires the expertise of researchers with deep knowledge both in the SNDS and in pharmacological reasoning.</p></div><div><p>Le système national des données de santé (SNDS) est l’un des plus grands entrepôts de données médico-administratives au monde, permettant la réalisation d’études pharmaco-épidémiologiques puissantes, basées sur des données de vie réelle recueillies de manière prospective. En plus de l’importance d’un rationnel pharmacologique fort dans la réalisation de toutes études pharmacoépidémiologiques, des recommandations ont été élaborées afin d’améliorer la qualité de ces études. Ces recommandations soulignent l’importance d’une définition précise de la population étudiée, de l’évènement et de l’exposition, lors de la réalisation d’études sur les bases de données médico-adminsitratives. Le respect de certaines recommandations, notamment celles concernant l’identification d’une population ou d’un évènement spécifique ou celles sur la définition des périodes d’exposition ou des périodes à risque, peut être difficile lors de la réalisation d’études sur le SNDS en raison de sa structure et de la nature des données enregistrées. L’objectif de cet article est d’aider à l’application de ces recommandations lors de la réalisation d’études pharmacoépidémiologiques sur le SNDS en prenant en compte ses spécificités. La réalisation d’études robustes à partir de cette source de données riche mais complexe implique de combiner l’expertise de chercheurs ayant une connaissance approfondie à la fois de la structuration du SNDS et du raisonnement pharmacologique.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"92059883","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":"Alprazolam misuse: Analysis of French Addictovigilance Network data from 2011 to 2020","authors":"Laurine Diaz ,&nbsp;Céline Eiden ,&nbsp;Emilie Jouanjus ,&nbsp;Elisabeth Frauger ,&nbsp;Nathalie Fouilhé ,&nbsp;Samira Djezzar ,&nbsp;Valérie Gibaja ,&nbsp;Alexandra Boucher ,&nbsp;Reynald Le Boisselier ,&nbsp;Frédéric Libert ,&nbsp;Anne-Sylvie Caous ,&nbsp;Emilie Monzon ,&nbsp;Marylène Guerlais ,&nbsp;Amélie Daveluy ,&nbsp;Bernard Fauconneau ,&nbsp;Hélène Peyrière","doi":"10.1016/j.therap.2023.02.002","DOIUrl":"10.1016/j.therap.2023.02.002","url":null,"abstract":"<div><h3>Objectives</h3><p>Alprazolam, a high-potency and short-acting anxiolytic benzodiazepine, is one of the most misused benzodiazepines in France. In the context of various reports on alprazolam misuse during the COVID-19 pandemic, the objective of this study was to assess alprazolam abuse potential by analyzing French addictovigilance and international data.</p></div><div><h3>Methods</h3><p>Data collected from 2011 to 2020 using the following epidemiological tools of the French Addictovigilance Network were analyzed: spontaneous reports (SRs), OPPIDUM (addiction care center data), OSIAP (falsified prescriptions), DRAMES (substance-related deaths), and chemical submission surveys. Moreover, the VigiBase™ database was analyzed to evaluate alprazolam abuse liability worldwide.</p></div><div><h3>Results</h3><p><span>During the study period, 675 SRs concerning alprazolam misuse were recorded (sex ratio: ̴1; median age: 39 years). The desired effects were intensification of the therapeutic anxiolytic effect, euphoric effect, and management of substance withdrawal. Alprazolam was the third and first benzodiazepine listed in OPPIDUM and OSIAP surveys. Analysis of the SR and OPPIDUM data showed a recent increase in the alprazolam-opioid combination. In DRAMES data, alprazolam was directly linked to 11 deaths (associated with opioids in 10/11). VigiBase™ data analysis highlighted that France was the third country with the most cases of alprazolam misuse. The disproportionality analysis showed that in France, alprazolam was associated with higher risk of misuse and dependence compared with other benzodiazepines: reporting odds ratio</span> <!-->=<!--> <!-->1.43, (95% CI: 1.04–1.95) and<!--> <!-->=<!--> <!-->1.97 (95% CI:1.50–2.59), respectively.</p></div><div><h3>Conclusions</h3><p>This study highlighted an increase in various signals of alprazolam abuse in France, and an increased use of the alprazolam-opioid combination that was also linked to most of the recorded alprazolam-linked deaths. These signals have been reported also in the international literature, and should be thoroughly investigated.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9113231","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":"Non-medical use of baclofen: A case series and review of the literature","authors":"Jean-Marc Pelerin ,&nbsp;Lisa Fristot ,&nbsp;Valérie Gibaja ,&nbsp;Bruno Revol ,&nbsp;Pierre Gillet ,&nbsp;Juliana Lima-Tournebize","doi":"10.1016/j.therap.2023.02.007","DOIUrl":"10.1016/j.therap.2023.02.007","url":null,"abstract":"<div><h3>Background</h3><p>Baclofen is widely used for spastic disorders and, most recently, for addictive disorders. The first signals of baclofen abuse occurred in the last decade. This study aims to assess the motives, diversion sources, and routes of administration associated with the non-medical use of baclofen and examine health problems related to the non-medical use of baclofen.</p></div><div><h3>Methods</h3><p>Spontaneous reports of baclofen abuse reported to the addictovigilance centre of East France were analysed. A literature search was conducted using PubMed®, Web of Sciences®, and Google Scholar® databases. Both investigations were performed in February 2021 without a time limit.</p></div><div><h3>Results</h3><p>Forty-six cases were analysed (33 from the literature review and 13 from the addictovigilance base). Baclofen's non-medical use mainly affected male subjects with addictive history, but issues of primary abuse in subjects without any substance abuse history were also observed. Euphoria search was the most common reason for misuse. The route of administration included oral, snorting, and sublingual use. Some cases involving illegal sources were also observed. Most patients misusing baclofen presented severe complications, mainly represented by neurological and respiratory disturbances. Physical and psychological dependence on baclofen was observed in three persons.</p></div><div><h3>Conclusions</h3><p>Although baclofen abuse remains relatively infrequent or (most likely) underestimated, this study helped confirm baclofen's intrinsic abuse potential and make visible the baclofen-abuse-related health visible harms. Careful consideration and benefit-risk analysis should be employed when prescribing baclofen, and emergency departments should be aware of baclofen dangers in abuse situations.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9123215","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":"Asymptomatic drug-induced peripheral blood eosinophilia: A retrospective study using the French national pharmacovigilance database","authors":"Clément Cholle ,&nbsp;Johanna Rousset ,&nbsp;Paola Sanchez-Pena ,&nbsp;Audrey Fresse ,&nbsp;Nathalie Vernier ,&nbsp;Hervé Devilliers ,&nbsp;Aurélie Grandvuillemin ,&nbsp;the French Network of Pharmacovigilance Centres","doi":"10.1016/j.therap.2022.12.011","DOIUrl":"10.1016/j.therap.2022.12.011","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10511674","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":"Overview of literature monitoring practice of clinical trials vigilance units in French institutional sponsors – A study from the REVISE working group","authors":"Astrid Prioul ,&nbsp;Dorine Fournier ,&nbsp;Cécile Lefeuvre ,&nbsp;Sophie Duranton ,&nbsp;Pascale Olivier ,&nbsp;Emeline Blanc ,&nbsp;Laure Peyro-Saint-Paul ,&nbsp;Sophie Ruault ,&nbsp;Aurélie Jamet ,&nbsp;Catherine Mouchel","doi":"10.1016/j.therap.2023.02.008","DOIUrl":"10.1016/j.therap.2023.02.008","url":null,"abstract":"<div><h3>Introduction</h3><p>The evaluation of clinical trial (CT) safety is the main task of CT vigilance units. In addition to the management of adverse events, the units must review the literature to identify information that may impact the benefit-risk assessment of studies. In this survey, we investigated the literature monitoring (LM) activity of French Institutional Vigilance Units (IVU) from the working group “REflexion sur la VIgilance et la SEcurite des essais cliniques” (REVISE).</p></div><div><h3>Material and methods</h3><p>We sent a questionnaire of 26 questions, divided into four themes, to the 60 IVU: (1) Presentation of the IVU and the LM activity; (2) Used sources, queries and criteria for selecting articles; (3) Valuation of the LM and (4) Practical organisation.</p></div><div><h3>Results</h3><p>Of the 27 IVU that responded to the questionnaire, 85% of them carried out LM. This was mainly provided by medical staff to improve general knowledge (83%), to detect Adverse Reactions (AR) not listed in the reference documents (70%) and to detect new safety information (61%). Due to lack of time, staff, available recommendations and sources, only 21% of IVU conducted LM for all CT. On average, units reported four sources: ANSM information (96%), PubMed database (83%), EMA alerts (57%) and the subscription to APM international (48%). The LM had an impact on the CT of 57% of the IVU such as changing the conditions of a study (39%) or suspending a study (22%).</p></div><div><h3>Discussion/Conclusion</h3><p>LM is an important but time-consuming activity with heterogeneous practices. According to the results of this survey, we proposed seven ways to improve this practice: (1) Target the highest risk CT; (2) Refine the PubMed queries; (3) Use other tools; (4) Create a decision flowchart for the selection of PubMed articles; (5) Improve training; (6) Value the activity and (7) Outsource the activity.</p></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9087395","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}