Therapie最新文献

{"title":"Characteristics of patients who are initiated on long-acting buprenorphine (Buvidal®) in France: A retrospective cross-sectional study.","authors":"Alice Deschenau, Benoit Trojak, Georges Brousse, Lisa Blecha, Julien Azuar, Mathieu Chappuy, Benjamin Touchon, Margaux Kosim, Benjamin Rolland","doi":"10.1016/j.therap.2024.09.003","DOIUrl":"https://doi.org/10.1016/j.therap.2024.09.003","url":null,"abstract":"<p><strong>Aim: </strong>The long-acting buprenorphine Buvidal® is a recent type of opioid agonist treatment (OAT) used for opioid use disorder (OUD). It was initially suggested to preferentially use Buvidal® for specific OUD populations, including people in prison, or patients in recovery and on sublingual buprenorphine. We conducted a national study to examine whether the profile of patients treated with Buvidal® in France matched these initial recommendations.</p><p><strong>Methods: </strong>A retrospective cross-sectional study was conducted in 13 national addiction centers (outside prison), using the individual medical records of patients initiated on Buvidal®. Baseline characteristics were collected and described, including sociodemographic features, comorbid medical conditions, concurrent substance use and prescription drug misuse, and OAT features before Buvidal® initiation, respectively.</p><p><strong>Results: </strong>In total 101 patients (72.3% males, mean age 43.9±11.3years) were identified, which corresponded to one sixth of all patients treated with Buvidal® in France at the time of the study. Of them, 36 (36.4%) of them were professionally active, 35 (35.4%) were durably inactive, and the rest in an intermediary situation. Furthermore, 90 (90.0%) patients had at least one medical comorbidity (all types), and 83 (83.0%) at least one psychiatric comorbidity. Most frequent non-psychiatric comorbidities were chronic pain (n=20, 20.0%) and chronic viral infection (n=16, 17.8%). Current use of psychoactive substances included cocaine and crack (n=43, 42.6%), heroin (n=19, 18.8%), but also misuse of prescription drugs (n=20, 20%), mainly opioid analgesics. Moreover, 99 (98.0%) patients had an OAT before Buvidal® initiation, including 7 (8.1%) patients on methadone.</p><p><strong>Conclusion: </strong>The profile of patients initiated on Buvidal® in France was extremely similar to that of patients treated for OUD in France, either in terms of social or clinical features. While initial recommendations essentially underlined the interest of Buvidal® for some niche populations, the on-the-ground practice reveals a more widespread use, including for unrecovered patients, or patients treated with methadone.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508624","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":"Ischemic cardiopathy induced by capecitabine in gastric cancer: The role of dihydropyrimidine dehydrogenase metabolites.","authors":"Joaquim Verdaguer, Laurent Chouchana, Marion Robert, Sandrine Bergeron, François Montastruc, Romain Barus","doi":"10.1016/j.therap.2024.09.001","DOIUrl":"https://doi.org/10.1016/j.therap.2024.09.001","url":null,"abstract":"<p><strong>Objectives: </strong>Fluoropyrimidine-based therapies, 5-fluorouracil (5-FU) and its oral prodrugs, capecitabine and tegafur/oteracil/gimeracil (S-1), are pivotal drugs to treat gastric cancer. Fluoropyrimidines are associated with cardiotoxicity including ischemic cardiopathy. The mechanisms of ischemic cardiopathy are considered to be multifactorial, potentially involving metabolites of 5-FU generated by the dihydropyrimidine dehydrogenase (DPD). By using Vigibase®, the World Health Organization pharmacovigilance database, we aimed to investigate the implication of the 5-FU metabolites induced by DPD in the occurrence of ischemic cardiopathy in patients with gastric cancer using capecitabine.</p><p><strong>Methods: </strong>In Vigibase®, we included serious reports of ischemic cardiopathy with capecitabine and S-1 from January 1st, 2013, to September 16th, 2023. Among patients with gastric cancer, we calculated the reporting odds ratio (ROR) of ischemic cardiopathy to compare capecitabine (a prodrug without DPD antagonist) with S-1 (a prodrug associated with a DPD antagonist). The ROR was also calculated regardless of the drug indication. An ancillary analysis based on the French pharmacovigilance database was also performed. We evaluated the ROR of serious cardiac disorders induced by 5-FU intravenous infusion according to the DPD status (no deficiency versus complete or partial deficiency).</p><p><strong>Results: </strong>In gastric cancer, 1843 reports (including 23 ischemic cardiopathy) for capecitabine and 2225 reports (including 17 ischemic cardiopathy) for S-1 were included. Median time-to-onset was 7 (3-26) days for capecitabine and 22 (13.25-30) days for S-1. Capecitabine was associated with an increased ROR of ischemic cardiopathy compared with S-1 in gastric cancer (ROR=1.6; [95% CI=1.5-1.8]) and regardless of the indication (7.3; [95% CI=6.6-8.0]). In the ancillary analysis, among 5-FU users, the lack of DPD deficiency increased the ROR for cardiac disorders (2.1; [95% CI=1.9-2.3]) compared to the DPD deficiency.</p><p><strong>Conclusion: </strong>This work supports the role of toxic 5-FU metabolites generated by dihydropyrimidine dehydrogenase in the occurrence of ischemic cardiopathy among patients with gastric cancer using capecitabine.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142508625","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, Anaïs Barbier, Mathilde Dambrine, Laurine Robert, Chloé Rousselière, Estel Cuneo, Pascal Odou, Sophie Gautier, Jean-Baptiste Beuscart, Marie-Laure Laroche, Bertrand Décaudin","doi":"10.1016/j.therap.2024.09.002","DOIUrl":"https://doi.org/10.1016/j.therap.2024.09.002","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>All REMEDIES criteria (n=104) were translated into seminatural language. This study is the first to have translated the 104 REMEDI[e]s explicit criteria into seminatural language.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-10-05","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":"Elexacaftor/tezacaftor/ivacaftor induced liver enzymes abnormalities in breastfed infants: A series of 3 cases.","authors":"Sandrine Bergeron, Camille Audousset, Gurvan Bourdon, Charles Garabedian, Sophie Gautier","doi":"10.1016/j.therap.2024.08.001","DOIUrl":"https://doi.org/10.1016/j.therap.2024.08.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142296166","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":"Retinal vascular occlusion after COVID-19 vaccination: Analysis of the French pharmacovigilance database.","authors":"Mathilde Beurrier, Jean-Bapiste Conart, Marie Lauren Antoine, Anthony Facile, Haleh Bagheri, Valérie Gras-Champel, Nadine Petitpain","doi":"10.1016/j.therap.2024.08.002","DOIUrl":"https://doi.org/10.1016/j.therap.2024.08.002","url":null,"abstract":"<p><p>Retinal vein occlusions and central retinal artery occlusions have been reported with coronavirus disease 2019 (COVID-19) vaccines. We aim to provide a descriptive analysis of cases reported in France until mid-2023, and recorded in the French pharmacovigilance database. An independent ophthalmologist reviewed all cases. We analyzed 290 cases (228 retinal vein occlusions, 58 central retinal artery occlusions, and four combinations). Retinal vein occlusions occurred with mRNA vaccines (68.0%) and adenovirus-vectored vaccines (32%), with an 11-day median onset delay. Almost half of the patients had retinal vein occlusion risk factors, mainly hypertension, and five had a positive rechallenge. Considering the lower adenovirus-vectored vaccines exposure in France, their proportion of retinal vein occlusions appears high. Among the 58 central retinal artery occlusion cases, most occurred with mRNA vaccines in patients with retinal artery occlusion risk factors (mainly hypertension), with a 17-day median onset delay. In conclusion, there was a temporal association in almost half of cases, but few cases with positive rechallenge, and many cases were confounded by risk factors (e.g., cardiovascular disorders, diabetes), which are also COVID-19 risk factors. Therefore, the risk of retinal vascular occlusion does not challenge the benefit-risk ratio of the vaccination, especially for mRNA vaccines.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142296167","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":"Ipomoea species, glorious but dangerous plants: A case-series","authors":"","doi":"10.1016/j.therap.2024.01.005","DOIUrl":"10.1016/j.therap.2024.01.005","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 5","pages":"Pages 606-609"},"PeriodicalIF":2.2,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139884015","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":"Chirurgie bariatrique et médicaments : revue de la littérature et analyse des effets indésirables dans la banque nationale de pharmacovigilance","authors":"","doi":"10.1016/j.therap.2024.02.003","DOIUrl":"10.1016/j.therap.2024.02.003","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;La chirurgie bariatrique est le seul traitement de l’obésité sévère (IMC&lt;!--&gt; &lt;!--&gt;&gt;&lt;!--&gt; &lt;!--&gt;35&lt;!--&gt; &lt;!--&gt;kg/m&lt;sup&gt;2&lt;/sup&gt;) actuellement reconnu comme efficace à la fois sur la perte pondérale de façon tangible et durable et l’amélioration, voire la rémission des comorbidités liées à l’obésité, telles que le diabète de type 2, l’hypertension artérielle, et les complications cardiovasculaires. La chirurgie bariatrique, comme toute autre chirurgie du tractus digestif, peut avoir des retentissements sur l’absorption des nutriments mais également des médicaments. Les publications étudiant la prise en charge médicamenteuse des patients opérés concernent essentiellement des cas rapportés ou des études rétrospectives incluant un petit nombre de patients. On ne dispose pas de références officielles.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Méthodes&lt;/h3&gt;&lt;div&gt;Nous avons réalisé une recherche des données de la littérature sur les conséquences de la chirurgie bariatrique au niveau de la biodisponibilité et/ou de l’effet du médicament. La base de données Medline® (PubMed) a été interrogée en utilisant les mots clés suivants : « &lt;em&gt;bariatric surgery&lt;/em&gt; », « &lt;em&gt;bioavailability&lt;/em&gt; », « &lt;em&gt;gastric bypass&lt;/em&gt; », et « &lt;em&gt;obesity&lt;/em&gt; ». Nous avons complété cette revue par une analyse des notifications d’effets indésirables (EIs) chez les patients en post-chirurgie bariatrique pour obésité enregistrées dans la banque nationale de pharmacovigilance (BNPV). Nous avons sélectionné tous les cas avec la mention chirurgie bariatrique et/ou gastrectomie comme « antécédent ». Après lecture des cas, nous avons exclu les cas où le patient a bénéficié d’une chirurgie pour une autre indication que l’obésité, où la voie d’administration était autre que la voie orale et les cas dont les EIs résultaient de surdosage volontaire, tentative de suicide, d’allergie, du passage au Lévothyrox® nouvelle formule, du méningiome sous progestatif, d’une inefficacité liée à une substitution par un générique et d’une erreur médicamenteuse.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;La recherche de la littérature a permis d’identifier essentiellement des publications type « &lt;em&gt;case report&lt;/em&gt; » sur l’impact de la chirurgie bariatrique sur les médicaments dits à « fenêtre thérapeutique étroite ». L’interrogation de la BNPV a permis d’identifier 66 cas informatifs sur un total de 565 cas sélectionnés (11 %). Néanmoins, les informations ne permettent pas souvent d’établir un lien évident entre la survenue de l’effet indésirable et l’influence de la chirurgie bariatrique.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion&lt;/h3&gt;&lt;div&gt;On note un manque d’informations officielles et/ou recommandations sur la prise des médicaments chez les sujets ayant subi une chirurgie bariatrique. En dehors de la sous-notification, les déclarations des effets indésirables restent peu informatives. Une sensibilisation des professionnels de santé et des patients sur la déclaration des effets indésirables chez cette pop","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 5","pages":"Pages 577-587"},"PeriodicalIF":2.2,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140065924","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":"Questionnaire about therapeutic drug monitoring (TDM) of psychotropics for a panel of French psychiatrists","authors":"","doi":"10.1016/j.therap.2024.01.004","DOIUrl":"10.1016/j.therap.2024.01.004","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 5","pages":"Pages 603-606"},"PeriodicalIF":2.2,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139736251","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":"Syndrome de Stevens-Johnson induit par la lymécycline chez un adolescent de 17 ans : cas clinique et revue de la littérature","authors":"","doi":"10.1016/j.therap.2024.04.004","DOIUrl":"10.1016/j.therap.2024.04.004","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 5","pages":"Pages 619-621"},"PeriodicalIF":2.2,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140755980","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":"Teaching pharmacovigilance to French medical students during the COVID-19 pandemic: Interest of distance learning clinical reasoning sessions","authors":"","doi":"10.1016/j.therap.2023.12.003","DOIUrl":"10.1016/j.therap.2023.12.003","url":null,"abstract":"<div><h3>Background</h3><div>Considering data from the literature in favor of active educational intervention to teach pharmacovigilance, we describe an innovative model of distance learning clinical reasoning sessions (CRS) of pharmacovigilance with 3rd year medical French students.</div></div><div><h3>Methods</h3><div>The three main objectives were to identify the elements necessary for the diagnosis of an adverse drug reaction, report an adverse drug reaction and perform drug causality assessment. The training was organized in 3 stages. First, students practiced clinical reasoning (CRS) by conducting fictive pharmacovigilance telehealth consultations. Second, students wrote a medical letter summarizing the telehealth consultation and analyzing the drug causality assessment. This letter was sent to the teacher for a graded evaluation. In the third stage was a debriefing course with all the students.</div></div><div><h3>Results</h3><div>Of the 293 third-year medical students enrolled in this course, 274 participated in the distance learning CRS. The evaluation received feedback from 195 students, with an average score of 8.85 out of 10. The qualitative evaluation had only positive feedback. The students appreciated the different format of the teaching, with the possibility to be active.</div></div><div><h3>Conclusion</h3><div>Through distance CRS of pharmacovigilance, medical students’ competences to identify and report adverse drug reactions were tested. The students experienced the pharmacovigilance skills necessary to detect adverse drug reactions in a manner directly relevant to patient care. The overall evaluation of the students is in favor of this type of method.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 5","pages":"Pages 553-558"},"PeriodicalIF":2.2,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139538881","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}