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Retinal vascular occlusion after COVID-19 vaccination: Analysis of the French pharmacovigilance database 接种 COVID-19 疫苗后视网膜血管闭塞:法国药物警戒数据库分析。
IF 2.2 4区 医学
Therapie Pub Date : 2025-05-01 DOI: 10.1016/j.therap.2024.08.002
Mathilde Beurrier , Jean-Bapiste Conart , Marie Lauren Antoine , Anthony Facile , Haleh Bagheri , Valérie Gras-Champel , Nadine Petitpain
{"title":"Retinal vascular occlusion after COVID-19 vaccination: Analysis of the French pharmacovigilance database","authors":"Mathilde Beurrier ,&nbsp;Jean-Bapiste Conart ,&nbsp;Marie Lauren Antoine ,&nbsp;Anthony Facile ,&nbsp;Haleh Bagheri ,&nbsp;Valérie Gras-Champel ,&nbsp;Nadine Petitpain","doi":"10.1016/j.therap.2024.08.002","DOIUrl":"10.1016/j.therap.2024.08.002","url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 295-303"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","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}
引用次数: 0
Évaluation des dépenses du circuit des produits de santé dans le cadre d’études institutionnelles – Étude de cas au CHU de Toulouse 作为机构研究一部分的医疗产品巡回支出评估--图卢兹大学医院案例研究
IF 2.2 4区 医学
Therapie Pub Date : 2025-05-01 DOI: 10.1016/j.therap.2024.06.001
Marie Delon, Pierjan Fourniols, Anabel Saint-Pastou, Geoffrey Bourcier, Audrey Tranier, Laetitia Caturla, Camille Jurado
{"title":"Évaluation des dépenses du circuit des produits de santé dans le cadre d’études institutionnelles – Étude de cas au CHU de Toulouse","authors":"Marie Delon,&nbsp;Pierjan Fourniols,&nbsp;Anabel Saint-Pastou,&nbsp;Geoffrey Bourcier,&nbsp;Audrey Tranier,&nbsp;Laetitia Caturla,&nbsp;Camille Jurado","doi":"10.1016/j.therap.2024.06.001","DOIUrl":"10.1016/j.therap.2024.06.001","url":null,"abstract":"&lt;div&gt;&lt;div&gt;La recherche clinique institutionnelle est essentielle mais confrontée à des défis budgétaires imprévus notamment quand elle est centrée sur les produits de santé. Cette étude rétrospective analyse les devis et coûts réels de 13 études gérées par la pharmacie coordinatrice des essais cliniques du CHU de Toulouse. Elle vise à évaluer la précision des devis, identifier les événements impactant les essais cliniques et rechercher des variables d’ajustements budgétaires. Les résultats montrent que seulement deux des 13 études respectent leur devis initial, la plupart dépassant les marges prévues. Les coûts varient par secteur, avec des dépenses dépassant souvent le budget initial pour les envois et les conditionnements, tandis que les coûts liés à la distribution sont plus précis. Plusieurs facteurs influencent les coûts, notamment la durée de l’étude, la localisation des centres, le nombre d’inclusions, la stabilité du produit et les modifications du protocole. L’augmentation de la durée de l’étude entraîne des dépenses accrues dans tous les secteurs, tandis que la diminution du nombre d’inclusions tend à respecter le budget initial. En conclusion, la gestion budgétaire des essais cliniques est complexe en raison de nombreuses variables influentes. Une planification rigoureuse et la prise en compte des particularités de chaque étude sont essentielles pour des devis plus précis et le respect des budgets. Cette étude contribue à mieux comprendre les défis financiers des promoteurs institutionnels d’essais cliniques et à améliorer les méthodes de budgétisation pour les futures études cliniques.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;div&gt;Clinical research faces complex and unpredictable budgetary challenges, despite its central role in the development of healthcare products. This retrospective study examines the estimated and actual costs of 13 trials managed by the Clinical Trials Coordinating Pharmacy at the University Hospital of Toulouse. It aims to assess the accuracy of estimates, identify trial-influencing events and identify budget adjustment variables. The results show that only two of the 13 studies stay within their initial estimates, with most exceeding their projected margins. Costs vary by area, with shipping and packaging in particular exceeding the initial budget, while distribution costs are more accurately estimated. Several factors influence costs, including study duration, centre locations, number of enrolments, product stability and protocol amendments. Extending the study duration leads to increased costs in all areas, while reducing the number of inclusions tends to be in line with the original budget. In conclusion, budget management in clinical trials is complex due to numerous influencing variables. Careful planning and consideration of the specifics of each trial are crucial for more accurate estimates and budget adherence. This study enhances the understanding of the financial challenges faced by institutional sponsors of clinical trials ","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 259-269"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141407332","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
Voxelotor-induced pulmonary embolism Voxelotor 引起的肺栓塞。
IF 2.2 4区 医学
Therapie Pub Date : 2025-05-01 DOI: 10.1016/j.therap.2024.10.050
Pauline Schiro , Romain Barus , Laurent Chouchana , Rayane Sari , Pierre Cougoul , François Montastruc , Haleh Bagheri
{"title":"Voxelotor-induced pulmonary embolism","authors":"Pauline Schiro ,&nbsp;Romain Barus ,&nbsp;Laurent Chouchana ,&nbsp;Rayane Sari ,&nbsp;Pierre Cougoul ,&nbsp;François Montastruc ,&nbsp;Haleh Bagheri","doi":"10.1016/j.therap.2024.10.050","DOIUrl":"10.1016/j.therap.2024.10.050","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 343-346"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142558864","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
Oxybutynin induced blindness in a child: Case report 奥施布宁致儿童失明1例。
IF 2.2 4区 医学
Therapie Pub Date : 2025-05-01 DOI: 10.1016/j.therap.2024.11.003
Mouna Daldoul , Ahmed Zaiem , Yasmine Salem Mahjoubi , Ons Charfi , Ghozlane Lakhoua , Sarrah Kastalli , Riadh Daghfous , Imen Aouinti , Sihem El Aidli
{"title":"Oxybutynin induced blindness in a child: Case report","authors":"Mouna Daldoul ,&nbsp;Ahmed Zaiem ,&nbsp;Yasmine Salem Mahjoubi ,&nbsp;Ons Charfi ,&nbsp;Ghozlane Lakhoua ,&nbsp;Sarrah Kastalli ,&nbsp;Riadh Daghfous ,&nbsp;Imen Aouinti ,&nbsp;Sihem El Aidli","doi":"10.1016/j.therap.2024.11.003","DOIUrl":"10.1016/j.therap.2024.11.003","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 346-348"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814233","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
Concilier régulation du médicament et démocratie sanitaire : rôle des conseillers patient ou professionnel de santé à l’ANSM [平衡药品监管与健康民主:病人和医疗保健专业顾问在 ANSM 中的作用]。
IF 2.2 4区 医学
Therapie Pub Date : 2025-05-01 DOI: 10.1016/j.therap.2024.06.002
Patrick Maison , Trystan Bacon , Pascale Daynes , Christophe Decoene , Roseline Mazet , Thierry Vial , Stéphane Vignot , Laetitia Belgodère , Wahiba Oualikene-Gonin , Christelle Ratignier-Carbonneil
{"title":"Concilier régulation du médicament et démocratie sanitaire : rôle des conseillers patient ou professionnel de santé à l’ANSM","authors":"Patrick Maison ,&nbsp;Trystan Bacon ,&nbsp;Pascale Daynes ,&nbsp;Christophe Decoene ,&nbsp;Roseline Mazet ,&nbsp;Thierry Vial ,&nbsp;Stéphane Vignot ,&nbsp;Laetitia Belgodère ,&nbsp;Wahiba Oualikene-Gonin ,&nbsp;Christelle Ratignier-Carbonneil","doi":"10.1016/j.therap.2024.06.002","DOIUrl":"10.1016/j.therap.2024.06.002","url":null,"abstract":"&lt;div&gt;&lt;div&gt;L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) est une agence réglementaire et de santé publique. Ses actions de régulation, de police sanitaire et de protection de la santé publique imposent une parfaite adéquation avec le terrain et les différents acteurs concernés par l’utilisation des produits de santé. Depuis 2019, l’ANSM a adapté son organisation afin de promouvoir et améliorer ses interactions dans le cadre de sa politique d’ouverture à la société civile. Afin d’accompagner cette ambitieuse mutation et soutenir ses agents, l’Agence a recruté des conseillers reflétant les principaux profils d’utilisateurs de produits de santé : médecins, pharmaciens et patients. En collège ou individuellement, ils apportent un regard du « terrain » à chaque étape des processus de décision. Ils peuvent participer à l’évaluation des signalements et demandes comme aux validations de rapports ou aux instances d’échanges avec les parties prenantes. Ils interviennent notamment lorsque l’analyse nécessite une expertise au-delà des aspects scientifiques ou réglementaires. Ils peuvent aider à prendre en compte certains aspects du soin et les difficultés de terrain. Les conseillers participent à la lisibilité et à l’adéquation entre l’expertise réglementaire et/ou scientifique et le vécu des utilisateurs. Au-delà de l’aspect scientifique et thérapeutique, le médicament est aussi un objet économique, social et politique. Ainsi, sa régulation est particulièrement concernée par le besoin de démocratie sanitaire dont les conseillers sont les facilitateurs. Celle-ci impose une participation active des professionnels de santé, des patients et plus largement de la société civile dans la prise de décision. Dans ce contexte, la prise en compte de la pluralité des points de vue dans la régulation des produits de santé est nécessaire mais complexe. Elle peut être facilitée par l’adaptation des organisations, comme l’intégration de conseillers.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;div&gt;The French National Agency for Health Products (ANSM) is a regulatory and public health agency. Its regulatory, health policing and public health protection activities require a perfect fit with the field and the various people involved in the use of health products. Since 2019, the ANSM has adapted its organisation, procedures and processes to encourage and improve interaction with its stakeholders, as part of its policy of openness towards civil society. To accompany this ambitious change and to support its staff, the Agency has recruited advisors corresponding to the main users of health products: prescribers (doctor's hospital and outpatient), pharmacists and patients. Working as a group or individually, they provide a “lived” user perspective on health products at each stage of the evaluation process. They may be involved in the assessment of dossiers, signals or applications received by the Agency, in the internal validation of reports or in discussions with stakeholders. ","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 311-317"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141545304","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
A biological pharmacology network to secure the risk of drug–drug interaction with nirmatrelvir/ritonavir 生物药理学网络确保尼马瑞韦/利托那韦的药物相互作用风险
IF 2.2 4区 医学
Therapie Pub Date : 2025-05-01 DOI: 10.1016/j.therap.2024.07.003
Florian Lemaitre , Lidvine Boland , Camille Tron , Matthieu Grégoire , Véronique Lelong-Boulouard , Peggy Gandia , Françoise Goirand , Nicolas Gambier , Christelle Boglione-Kerrien , Bénédicte Franck , Sébastien Lalanne , Arnaud Devresse , Sebastien Briol , Vincent Haufroid , Marie-Clémence Verdier , SFPT Therapeutic Drug Monitoring, Treatment Personalization group (STP-PT) of the French Society of Pharmacology, Therapeutics (SFPT)
{"title":"A biological pharmacology network to secure the risk of drug–drug interaction with nirmatrelvir/ritonavir","authors":"Florian Lemaitre ,&nbsp;Lidvine Boland ,&nbsp;Camille Tron ,&nbsp;Matthieu Grégoire ,&nbsp;Véronique Lelong-Boulouard ,&nbsp;Peggy Gandia ,&nbsp;Françoise Goirand ,&nbsp;Nicolas Gambier ,&nbsp;Christelle Boglione-Kerrien ,&nbsp;Bénédicte Franck ,&nbsp;Sébastien Lalanne ,&nbsp;Arnaud Devresse ,&nbsp;Sebastien Briol ,&nbsp;Vincent Haufroid ,&nbsp;Marie-Clémence Verdier ,&nbsp;SFPT Therapeutic Drug Monitoring, Treatment Personalization group (STP-PT) of the French Society of Pharmacology, Therapeutics (SFPT)","doi":"10.1016/j.therap.2024.07.003","DOIUrl":"10.1016/j.therap.2024.07.003","url":null,"abstract":"<div><div>Nirmatrelvir/ritonavir is a protease inhibitor antiviral drug indicated in the treatment of severe acute respiratory syndrome coronavirus-2 infections in high-risk patients for a severe disease. Unfortunately, ritonavir, used to boost nirmatrelvir pharmacokinetics, can also inhibit or induce the metabolism of other co-administered drugs substrates. This may lead to a subsequent risk of adverse drug reaction and lack of efficacy. In this study, we aimed at describing the expert advices provided by the biological pharmacology network of the SFPT (i.e., the therapeutic drug monitoring specialists working in the laboratories of the pharmacology departments in France/Belgium). From February to August 2022, we collected all specialized advices provided by the biological pharmacology network of the SFPT. Seven pharmacology departments actively participated in the study (Brussels Saint-Luc Hospital in Belgium, Caen, Dijon, Nantes, Nancy, Rennes and Toulouse in France). We collected the following data: patient's age, date of nirmatrelvir/ritonavir initiation, clinical department requiring the expert advice, patient's treatments, and advice provided. One hundred and six expert advice on 753 drugs were provided during the seven months of data collection. Two centers provided 83% of all the expert advice (around 8/month). Patients originated form a transplantation department in 65% of the cases. The most common request were for cardiac drugs (28%), immunosuppressive drugs (24%) and endocrine drugs (18%). The advice were distributed as follows: treatment continuation, treatment discontinuation during the antiviral course, dosage adjustment, and treatment switch in 59%, 28%, 11%, and 1.6% of the cases, respectively. Only 2 pieces of advice (0.3%) constituted treatment contra-indications. Drug monitoring was proposed in 10% of prescription lines. Expert advice provided by the biological pharmacology network of the SFPT allows securing the combination of nirmatrelvir/ritonavir with other concomitant drugs. Most of eligible patients to the antiviral drug can benefit from it despite the risk of drug–drug interaction.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 327-332"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141852462","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
Utilisation d’un système d’aide à la décision pharmaceutique dans la valorisation des séjours hospitaliers : évaluation à travers 3 exemples en collaboration avec le département de l’information médicale [在住院评估中使用医药决策支持系统:通过与医疗信息部门合作的 3 个实例进行评估]。
IF 2.2 4区 医学
Therapie Pub Date : 2025-05-01 DOI: 10.1016/j.therap.2024.07.004
Laurine Robert , Ali Laraba , Amélie Bruandet , Alexandra Royer , Pascal Odou , Bertrand Décaudin , Chloé Rousselière
{"title":"Utilisation d’un système d’aide à la décision pharmaceutique dans la valorisation des séjours hospitaliers : évaluation à travers 3 exemples en collaboration avec le département de l’information médicale","authors":"Laurine Robert ,&nbsp;Ali Laraba ,&nbsp;Amélie Bruandet ,&nbsp;Alexandra Royer ,&nbsp;Pascal Odou ,&nbsp;Bertrand Décaudin ,&nbsp;Chloé Rousselière","doi":"10.1016/j.therap.2024.07.004","DOIUrl":"10.1016/j.therap.2024.07.004","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;Les systèmes d’aide à la décision en pharmacie (SADP) permettent d’aider le pharmacien clinicien dans la prévention et la détection des événements indésirables médicamenteux. Le codage des séjours, par le département d’information médicale (DIM), nécessite une expertise car il conditionne les recettes des hôpitaux et les données épidémiologiques transmises via le programme de médicalisation des systèmes d’information. L’objectif était d’étudier l’intérêt et la faisabilité de l’utilisation d’un SADP, en collaboration avec le DIM, pour aider au codage des séjours hospitaliers.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Méthodes&lt;/h3&gt;&lt;div&gt;Sur 5 mois, trois règles ont été implémentées dans le SADP pour détecter la goutte, la maladie de Parkinson et les candidoses oropharyngées. Les alertes du SADP ont été analysées par un interne en pharmacie puis transmis au DIM, qui a analysé les séjours pour voir si le codage de la maladie correspondant à l’alerte était présent ou non. L’absence de codage a été évaluée et tracée, avec le changement de sévérité et la valorisation induite.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Résultats&lt;/h3&gt;&lt;div&gt;Trois cent dix-neuf alertes issues du SADP ont été analysées et envoyées au DIM, représentant 211 séjours et 309 résumés standardisés de séjour (RSS) en MCO. Deux cent huit (67,3 %) RSS n’avaient pas le codage correspondant à l’alerte. Pour la majorité de ces RSS, hormis la précision du diagnostic, il n’y a pas eu d’impact sur la valorisation des séjours. Pour 4 RSS, l’ajout du code diagnostic a permis une valorisation du séjour et l’augmentation de la sévérité des groupements homogènes de malade. La revalorisation totale correspondant à cette modification était de 5416 €.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Discussion&lt;/h3&gt;&lt;div&gt;L’utilisation du SADP a aidé dans la précision du codage des diagnostics et la valorisation des séjours. Ce résultat est à pondérer face au temps investi pour l’analyse des alertes et des codages associés. Une amélioration de la détection des maladies et du traitement des données est nécessaire pour pouvoir être réalisable en pratique en considérant les plus de 227 600 RSS réalisés par an au sein de notre établissement.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;Pharmacy decision support systems (PDSS) help clinical pharmacists to prevent and detect adverse drug events. The coding of hospital stays by the department of medical information (DMI) requires expertise, as it determines hospital revenues and the epidemiological data transmitted via the French national hospital database. The aim was to study the interest and feasibility of using a PDSS, in collaboration with the DMI, to help with the coding of hospital stays.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;Over 5 months, three rules were implemented in the PDSS to detect gout, Parkinson's disease and oro-pharyngeal candidiasis. The PDSS alerts were analyzed by a pharmacy resident and then forwarded to the DMI, who analyzed the stays to see whether or not the coding for the diseas","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 319-326"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142081621","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
Ischemic cardiopathy induced by capecitabine in gastric cancer: The role of dihydropyrimidine dehydrogenase metabolites 胃癌患者卡培他滨诱发的缺血性心肌病:二氢嘧啶脱氢酶代谢物的作用。
IF 2.2 4区 医学
Therapie Pub Date : 2025-05-01 DOI: 10.1016/j.therap.2024.09.001
Joaquim Verdaguer , Laurent Chouchana , Marion Robert , Sandrine Bergeron , François Montastruc , Romain Barus
{"title":"Ischemic cardiopathy induced by capecitabine in gastric cancer: The role of dihydropyrimidine dehydrogenase metabolites","authors":"Joaquim Verdaguer ,&nbsp;Laurent Chouchana ,&nbsp;Marion Robert ,&nbsp;Sandrine Bergeron ,&nbsp;François Montastruc ,&nbsp;Romain Barus","doi":"10.1016/j.therap.2024.09.001","DOIUrl":"10.1016/j.therap.2024.09.001","url":null,"abstract":"<div><h3>Objectives</h3><div>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.</div></div><div><h3>Methods</h3><div>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).</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 305-309"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","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}
引用次数: 0
Polyintoxication with cenobamate, perampanel, and carbamazepine: A complex case report 多中毒与辛奥巴酸,perampanel和卡马西平:一个复杂的病例报告。
IF 2.2 4区 医学
Therapie Pub Date : 2025-05-01 DOI: 10.1016/j.therap.2024.12.001
Alexandre Destere , Alexandre O. Gérard , Diane Merino , Elliot Ewig , Fanny Rocher , Nouha Ben Othmann , Benjamin Hennart , Jean Dellamonica , Hervé Hyvernat , Milou-Daniel Drici
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引用次数: 0
Lactulose induced maculo-papular eruption with positive rechallenge: Unusual reaction to this medication 乳果糖诱导的斑疹丘疹阳性再挑战:对这种药物的不寻常反应。
IF 2.2 4区 医学
Therapie Pub Date : 2025-05-01 DOI: 10.1016/j.therap.2024.12.004
Imen Bouaziz , Rim Atheymen , Khadija Sellami , Rym Sahnoun , Kamilia Ksouda , Emna Bahloul , Hanen Affes , Serria Hammami , Hamida Turki , Khaled Zghal
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引用次数: 0
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