Therapie最新文献

{"title":"Drug-induced fluorosis: A study based on the national and international pharmacovigilance databases.","authors":"Myriam Mellou, Bénédicte Lelièvre, Delphine Bourneau-Martin, Christine Le Beller, Véronique Pizzoglio, Gwenaelle Veyrac, Joelle Michot, François Parant, Marie Briet","doi":"10.1016/j.therap.2025.06.006","DOIUrl":"https://doi.org/10.1016/j.therap.2025.06.006","url":null,"abstract":"<p><strong>Objectives: </strong>Despite the widespread use of fluorinated medicines - with approximately 20% of the drugs marketed in 2020 containing fluoride compounds - the association between these medications and fluorosis remains under-recognized. This study aimed to identify medications most likely to induce fluorosis in real-world clinical settings using pharmacovigilance databases.</p><p><strong>Methods: </strong>A descriptive and disproportionality study was conducted using French national (FPVB) and international pharmacovigilance databases (VigiBase®). Cases of fluorosis were extracted from Vigibase® up to July 8, 2024, using the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms \"fluorosis\", \"fluoride increased\" and \"fluorosis dental\". French cases were subsequently extracted from the FPVB. Disproportionality signals were evaluated by calculating the reporting odds ratio (ROR) and corresponding 95% confidence interval (CI).</p><p><strong>Results: </strong>A total of 72 cases of suspected drug-induced fluorosis were identified in VigiBase®. The most frequently reported adverse effects were musculoskeletal disorders (n=39, 54.2%), dental disorders (n=11, 15.3%), and eyes and visual disorders (n=8, 11.1%). Two-third of the cases (n=52) were classified as serious. In 40% of cases (n=29), the outcome was favorable. Voriconazole, sodium fluoride, fluconazole and ciprofloxacin were identified as single suspects. Disproportionality signals were detected for sodium fluoride (ROR=2305.7; 95% CI [1143.9; 4647.3]), voriconazole (ROR=1415.4; 95% CI [891.5; 2247.3]), fluconazole (ROR=110.4; 95% CI [52.9; 230.3]), fludarabine (ROR=87.3; 95% CI [31.8; 239.3]) and ciprofloxacin (ROR=7.1; 95% CI [2.2; 22.4]). The 16 cases from the FPVB provided more detailed information, including the clinical context - mainly hematological malignancies (37.5%) and organ transplants (12.5%) - the median time to onset (361 days), mean plasma fluoride concentration (1.33mg/L; range 0.006-7.2mg/L), and results imaging explorations.</p><p><strong>Conclusion: </strong>This study highlights pharmacovigilance signals suggesting a potential association between fluorosis and certain fluorinated compounds, particularly sodium fluoride, voriconazole, fluconazole, fludarabine and ciprofloxacin. Among these, only sodium fluoride and voriconazole include fluorosis in the summary of product characteristics. Clinicians should remain vigilant regarding this potential adverse drug reaction, especially with long-term use of these medications.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144675648","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":"Pharmaceutical consultation as a harm reduction intervention in chemsex?","authors":"Stanislas Maisonnneuve, Chadi Abbara, Marina Babin, Marie Briet, Guillaume Drevin","doi":"10.1016/j.therap.2025.06.007","DOIUrl":"https://doi.org/10.1016/j.therap.2025.06.007","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144660311","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}

{"title":"[Early non-compliance with oral anticancer drugs, a clinical pharmacy as key issue in onco-senology].","authors":"Fanny Leenhardt, Pauline Ares, Alma Nicolai, Cécile Corbinais, Marie Viala, Véronique d'Hondt, François Jouvet, Frédéric Pinguet","doi":"10.1016/j.therap.2025.06.001","DOIUrl":"10.1016/j.therap.2025.06.001","url":null,"abstract":"<p><strong>Introduction: </strong>The assessment of adherence is necessary to ensure therapeutic compliance, particularly with oral anti-cancer drugs (OACs). Already easily implemented, the nationally validated GIRERD questionnaire seems incomplete for assessing adherence. We set out to study and characterize adherence in a cohort of patients treated with OACs, using 2 questionnaires.</p><p><strong>Material and methods: </strong>The evaluation was carried out in patients treated with OAC using the GIRERD questionnaire, composed of 6 items, and an institutional questionnaire consisting of 7 items; with a common gradation based on that of the GIRERD score. These questionnaires were submitted within the first 3 months of ribociclib (OAC) initiation, in women with metastatic hormone-dependent breast cancer.</p><p><strong>Results: </strong>Of the 50 evaluable patients, around 60% had a score above 0 (poorly observant [PO]+unobservant [UO]) according to the 2 questionnaires during this study. UO patients represent 6% according to the GIRERD score and 16% according to the institutional score. The main causes of non-adherence were late dosing (21/50) and forgetting to take the ACO when travelling (13/50). Fifty-four percent of patients who had an aid to help them take their ACO (pillbox, etc.) proved to be unobservant.</p><p><strong>Discussion: </strong>More than half of patients had at least one non-adherence event in the first 3 months of OAC, indicating a need to secure the initiation of these treatments. Compliance must be assessed using appropriate tools. Finally, the institutional score intercepts more outright non-compliance, whereas the GIRERD score would underestimate non-compliance in our cohort.</p><p><strong>Conclusion: </strong>More than half the patients in our cohort appear to be poorly compliant at an early stage, whatever the assessment score. This assessment of compliance constitutes a feasibility study for the use of our questionnaire in routine clinical monitoring of patients receiving an OAC.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144340397","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 venous occlusion in drug-induced lupus.","authors":"Adrien Blanc, Charles Khouri, Laurence Bouillet, Christophe Chiquet","doi":"10.1016/j.therap.2025.05.003","DOIUrl":"https://doi.org/10.1016/j.therap.2025.05.003","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144294965","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":"[The French IRB Study: Qualification of research by ethics committees].","authors":"Charles-Hervé Vacheron, Arnaud Friggeri, Maxime Lambert, Laura Shoonjans, Philippe Amiel","doi":"10.1016/j.therap.2025.05.002","DOIUrl":"https://doi.org/10.1016/j.therap.2025.05.002","url":null,"abstract":"<p><strong>Objectives: </strong>In France, the \"Research investigations involving human subjects\" (RIPH), defined in the Public Health Code, are reviewed by \"committees for the protection of persons\" (CPP) established by law. Other research studies in health are evaluated conducted by \"research ethics committees\" (CER) that can be established by research institutions (institutes, hospitals, universities, etc.) without a defined legal framework. The qualification of the research as RIPH or \"non-RIPH\" (RNIPH) determines the evaluation pathway - mandatory legal or extra-legal. Our objective was to describe the performance of CERs and CPPs in qualifying research projects as RIPH or RNIPH, the qualification standard used being the \"Guide to the qualification of health research\", an Inserm reference published in 2021.</p><p><strong>Methods: </strong>Since the list of CPPs was already known, universities, university hospitals, and learned societies in medical specialties were contacted to find out if they housed a CER. Between 29/01/2024 and 29/02/2024, all documented CPPs and CERs were asked to participate in the study. If accepted, an email was sent to members with an online questionnaire proposing four cases to be qualified, either RIPH or non-RIPH. The cases were taken from the examples provided by the Inserm guide, which also served as a reference for assessing the responses. The analysis of the responses was carried out individually and at the level of each participating committee.</p><p><strong>Results: </strong>Thirty-five (35) centers, out of the 110 contacted, participated, producing 175 individual responses collected. The number of members per committee was 18 [12-23]. The response rate per committee was 27% [14-47]. Regarding the members' responses, the qualification was consistent with that of the Inserm guide in 79% (138), 62% (108), 66% (116), and 61% (106) of cases. At the committee level, a wide disparity between the different centers was documented, without notable differences between CER and CPP.</p><p><strong>Conclusion: </strong>A significant heterogeneity in the qualification of research was noted between the different committees, unrelated to the type of structure (CER or CPP). Information and training systems, aimed at all types of committees, should be encouraged to standardize the research qualification step.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144187995","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":"Patients under treatment for sarcoidosis reported adherence issues and would welcome personalized pharmaceutical care: Results from survey online.","authors":"Cléa Dubrou, Dorian Protzenko, Aurélie S Leroyer, Raphael Cauchois, Gilles Kaplanski, Guillaume Hache","doi":"10.1016/j.therap.2025.05.001","DOIUrl":"https://doi.org/10.1016/j.therap.2025.05.001","url":null,"abstract":"<p><p>Sarcoidosis is an immune-inflammatory condition marked by significant health disparities. Around 50% of individuals diagnosed with sarcoidosis need long-term or even lifelong treatment to halt the progression of the disease. Recent guidelines, primarily targeting pulmonary sarcoidosis, have been proposed. Despite this, reports on medication adherence in sarcoidosis are scarce, and pharmaceutical care is rarely incorporated into patient-centered treatment strategies. In our study, we conducted a survey through social media (n=157) and discovered that 79% of participants were either slightly or not at all adherent to their medication regimen, according to the Girerd score. The primary goal of this project is to pinpoint the factors influencing non-adherence among sarcoidosis patients. We identified that treatment involving corticosteroids or corticosteroid-sparing drugs, coupled with factors like age and pulmonary localization, are linked to poorer adherence outcomes. Moreover, patients demonstrating poor adherence showed a readiness to engage in personalized pharmaceutical care.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144133244","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}