Therapie最新文献

{"title":"Behavioral tics following sublingual allergen immunotherapy (OSIRIS): A case report.","authors":"Ludivine Traverso, Marie Mittaine, Haleh Bagheri","doi":"10.1016/j.therap.2026.08.002","DOIUrl":"https://doi.org/10.1016/j.therap.2026.08.002","url":null,"abstract":"<p><p>We report the case of a 14-year-old boy who developed motor and vocal tics following sublingual immunotherapy with OSIRIS Acariens mix for allergic rhinitis. The tics resolved upon temporary discontinuation and reappeared upon rechallenge. To our knowledge, this is the first report of such an adverse event associated with this allergen extract. We discuss the potential link between allergic diseases, immunotherapy, and tic disorders, highlighting the need for careful monitoring of unexpected adverse events.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149196729","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":"[When the vaccine triggers pustulosis: A case of post-vaccination pustulosis following administration of an inactivated COVID-19 vaccine].","authors":"Zakia Douhi, Saâdia Boughaleb, Badreddine Moukafih, Meriem Soughi, Sara Elloudi, Hanane Baybay, Fatima Zohra Mernissi","doi":"10.1016/j.therap.2026.09.043","DOIUrl":"https://doi.org/10.1016/j.therap.2026.09.043","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149148787","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":"Distinct pattern of reported adverse event with SGLT2 inhibitors in heart failure: A pharmacovigilance study using VigiBase data.","authors":"Omar Chebbo, François Roubille, Jean-Luc Faillie, Nicolas Chapet, Pascale Palassin","doi":"10.1016/j.therap.2026.07.007","DOIUrl":"https://doi.org/10.1016/j.therap.2026.07.007","url":null,"abstract":"<p><strong>Background and aims: </strong>Sodium-glucose cotransporter 2 inhibitors (SGLT-2i), developed for type 2 diabetes mellitus (T2DM), have been approved in symptomatic heart failure (HF). Comparison of their safety profiles between T2DM and HF remain scarce. Using international pharmacovigilance data, reported adverse events (AEs) with SGLT-2i were compared between T2DM and HF indications.</p><p><strong>Methods: </strong>Individual case safety reports (ICSRs) involving dapagliflozin or empagliflozin, both approved for T2DM and HF, were collected from the World Health Organization's pharmacovigilance database up to September 30, 2024. Five AEs of interest were specifically investigated including ketoacidosis, genitourinary infection, Fournier's gangrene, amputation and kidney failure. Reporting odds ratio (ROR) and 95% confidence interval (CI) were calculated to compare reported AEs between T2DM and HF indication.</p><p><strong>Results: </strong>Of the 47,804 ICSRs selected, only 10.0% involved HF patients. Serious AEs accounted for 41.0% of cases in T2DM patients and 44.2% in HF patients. As expected, ketoacidosis (14.6% vs 4.1%), Fournier's gangrene (2.3% vs 1.8%), and amputation (0.5% vs 0.3%) were significantly more reported in T2DM and kidney failure was more reported in HF (6.1% vs 3.8% in T2DM). The differences were illustrated by significant ROR. However, no difference was evidenced for genitourinary tract infections between the two indications. Median time to onset of AEs was shorter in HF (111.5 days±198.7 vs 264.9±664.9 in T2DM, p<0.001) and AEs leading to death were more frequently reported in this subgroup.</p><p><strong>Conclusion: </strong>SGLT2 inhibitor safety profiles differ across indications, shaped in part by patient characteristics. In heart failure, the reporting of unexpected serious events, such as ketoacidosis, and a higher proportion of fatal outcomes sharply reinforces the need for intensified safety surveillance.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149002535","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":"[Buprenorphine and pain management: Clinical insights and practical landmarks].","authors":"Julien Cabe, Mathieu Chappuy, Christian Duale, Célian Bertin","doi":"10.1016/j.therap.2026.07.006","DOIUrl":"https://doi.org/10.1016/j.therap.2026.07.006","url":null,"abstract":"<p><p>Buprenorphine therapy is widely used in the treatment of opioid use disorder, and the use of its long-acting formulations is increasing. This raises concerns among healthcare professionals when analgesic management becomes necessary, due to its pharmacological properties. This article provides a synthesis of current pharmacological evidence and its implications for the management of acute and chronic pain, whether planned or unplanned. Practical landmarks are proposed according to the type of pain, the formulation used (buccal or subcutaneous), and the clinical context. Available data support the continuation of buprenorphine in most situations, including surgical settings, and suggest that a rational use of multimodal analgesia enables safe and effective pain management. Discontinuation of buprenorphine, long recommended to allow conventional analgesia with full opioid agonists, now appears to be a minority option, reserved for exceptional and anticipated cases. The management of patients receiving buprenorphine should not be viewed as a constraint, but rather as a pharmacological adaptation scenario grounded in well-established principles.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148956511","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":"Epidemiology and risk factors of severe cutaneous drug reactions and evaluation through available databases.","authors":"Thomas Bettuzzi, Bénédicte Lebrun-Vignes","doi":"10.1016/j.therap.2026.08.001","DOIUrl":"https://doi.org/10.1016/j.therap.2026.08.001","url":null,"abstract":"<p><p>Severe cutaneous adverse drug reactions (SCARs), comprising mainly Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, generalized bullous fixed drug eruption (GBFDE), are rare adverse reactions to drugs, hampered by a significant morbidity and mortality. Due to their unpredictable nature, they completely disrupt the benefit-risk balance of drug prescription. Nonetheless, a partial predictability is emerging. Firstly, all drugs do not carry the same risk for SCARs. Drugs carrying the higher risk are allopurinol, carbamazepine, lamotrigine, iodinated contrast media, and antibiotics, particularly sulfonamides and aminopenicillins. In addition, main risk factors comprise genetic polymorphisms of the HLA system and increased drug dosage. A targeted HLA genetic screening together with drug avoidance in case of high risk allowed to reduce the incidence of SCARs associated with carbamazepine and allopurinol. Similarly, a progressive titration of lamotrigine dose allowed to reduce the incidence of SCARs associated with lamotrigine. Pharmacovigilance databases allow the quick identification of culprit drugs, together with the implementation of whistle-blowing policies. Nonetheless, they present with quantitative and qualitative limitations and their own particular biases. Pharmacoepidemiologic databases allow the computation of SCAR incidences and confirm previously identified associations between drugs and SCARs. They may also allow help to identify the main clinical risk factors, e.g., chronic renal disease and Asian ethnicity for allopurinol. Nonetheless, they are limited by measure bias and lack of clinical and biological data. Ultimately, clinical and pharmacogenomic databases allow the identification of more precise risk factors, comprising precise genetic polymorphisms, drug dosage and impaired metabolism. The combination of all allows to establish a personalized risk stratification across SCARs subtypes and drug prescriptions. Ultimately, this allows the establishment of prescribing policies and the decrease of SCARs incidence.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148851582","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":"Occurrence of Gitelman-like syndrome in a patient on thiazide and proton pump inhibitor.","authors":"Nathaniel Angel, Christian Hulo, Tara Fauquex-Bopp, Kuntheavy Ing Lorenzini, Jacques Serratrice, Matteo Coen","doi":"10.1016/j.therap.2026.07.005","DOIUrl":"https://doi.org/10.1016/j.therap.2026.07.005","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148851613","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":"Characteristics of patients with opioid/benzodiazepine use disorder in a specialized consultation unit for prescription drug addiction: A cross-sectional study.","authors":"Ismahane Merah, Julia de Ternay, Anjesa Veseli, Wafae Chinoune, Delphine Ragonnet, Montassar Taj, Imane Salihi, Mathieu Chappuy, Benjamin Rolland","doi":"10.1016/j.therap.2026.07.004","DOIUrl":"https://doi.org/10.1016/j.therap.2026.07.004","url":null,"abstract":"<p><strong>Background: </strong>The \"Centre Ressource Lyonnais des Addictions Médicamenteuses\" (CERLAM), i.e., Lyon Resource Center for Prescription Drug Addiction, is a specialized addiction unit for all types of prescription drug use disorders. Using the structured initial assessment of the center, the specific profile of patients with prescription opioid (OUD) or benzodiazepine use disorder (BUD) was explored.</p><p><strong>Methods: </strong>The structured initial CERLAM assessment includes age, gender, international standardized classification of education (ISCED), DSM-5 criteria for OUD or BUD, Hospital Anxiety and Depression Scale (HADS), World Health Organization Quality of Life - 26-item version (WHOQOL-BREF), and Pittsburgh Sleep Quality Inventory (PSQI), respectively. Two multivariable logistic regression models explored the profile of OUD (vs. non-OUD) patients and BUD (vs. non-BUD patients), providing adjusted odds ratios and their 95% confidence intervals (aOR[95%CI]).</p><p><strong>Results: </strong>One hundred and eighty-four patients were included (54.9% females; mean age 44.7±13.4 years), among whom 107 (58.2%) had an OUD, and 86 (46.7%) a BUD. When compared with non-OUD patients, those with prescription OUD were more frequently females (aOR=1.97 [1.04-3.73]), had a lower ISCED (aOR=0.55 [0.42-0.72]), and a lower physical WHOQOL-BREF score (aOR=0.93 [0.88-0.99]). By contrast, when compared with non-BUD patients, those with BUD had a greater ISCED (aOR=2.04 [1.54-2.72]), reduced psychological (aOR=0.93 [0.87-0.99]) and social (aOR=0.86 [0.76-0.96]) WHOQOL-BREF scores, greater HAD depression (aOR=1.10 [1.03-1.18]) and PSQI (aOR=1.13 [1.04-1.23]) scores, respectively.</p><p><strong>Conclusion: </strong>In patients with prescription drug use disorders, those with BUD and those with OUD exhibit specific sociodemographic and psychological features, that need to be identified and treated independently.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148841276","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":"Anhedonia and neuropsychotropics: A pharmacovigilance-pharmacodynamic study.","authors":"Jean-Louis Montastruc","doi":"10.1016/j.therap.2026.07.003","DOIUrl":"https://doi.org/10.1016/j.therap.2026.07.003","url":null,"abstract":"<p><strong>Purpose: </strong>Anhedonia is defined as inability to experience pleasure or enjoyment from activities normally pleasurable. Role of drugs in occurrence of anhedonia is little known. The study was performed to investigate, first associations between anhedonia and exposure to neuropsychotropics and, second potential pharmacodynamic mechanisms of this adverse drug reaction.</p><p><strong>Methods: </strong>The first part of the study used individual case safety reports (ICSRs) in adults registered in the global pharmacovigilance database, Vigibase®, between 01/01/2000 and 31/12/2024 with neuropsychotropics. Results are shown as reporting odds ratios (ROR) with their 95%CI. Second, we performed a pharmacovigilance-pharmacodynamic study using linear regression analyses to explore the association between anhedonia with antidepressants and binding affinities for their monoamine transporters.</p><p><strong>Results: </strong>Among 24,913,179 ICSRs, 1123 reported anhedonia with neuropsychotropics, mainly in females (52.5%) and between 18-44 years (55.6%). Significant associations were found with psycholeptics [ROR=1.23 (1.14-1.33), including second generation of antipsychotics and anxiolytics], psychoanaleptics [ROR=1.66 (1.52-1.82), including serotonin reuptake inhibitors and venlafaxine but not other antidepressants] and some other drugs like naltrexone, varenicline, duloxetine, clonazepam or oxycodone. No association was found for anesthetics, other analgesics, other antiepileptics, hypnotics/sedatives, or antiparkinsonians. Direct drug comparisons found significant ROR values for psychoanaleptics versus psycholeptics [1.35 (1.20-1.51)], for antidepressants versus antipsychotics [2.63 (2.24-3.09)] and for antidepressants versus anxiolytics [1.27 (1.11-1.45)]. No significant association was found between monoamine pKi values and occurrence of anhedonia with antidepressants.</p><p><strong>Conclusion: </strong>Among neuropsychotropics, serotonin reuptake inhibitors, benzodiazepine anxiolytics and antipsychotics are associated with anhedonia reports. We were unable to find any correlation between anhedonia reports with antidepressants and their direct effects on monoamine transporters.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148798295","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":"Acute pancreatitis followed by leukocytoclastic vasculitis induced by tirzepatide: A first case report with this new medication.","authors":"Fatma Zgolli, Wiem Daly, Imen Aouinti, Israa Dahmani, Hela Haouet, Hatem Kooli, Sarrah Kastalli, Sihem El Aidli","doi":"10.1016/j.therap.2026.06.003","DOIUrl":"https://doi.org/10.1016/j.therap.2026.06.003","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148841327","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":"[Five years of ISO 9001 certification in pharmacotoxicology: Experience feedback and implementation modalities in vigilance structures].","authors":"Sabrina Pierre, Behrouz Kassai-Koupai, Marine Auffret, Alexandra Pereira, Guillaume Grenet, Blandine Bertin, Véronique Pizzoglio-Billaudaz","doi":"10.1016/j.therap.2026.07.002","DOIUrl":"https://doi.org/10.1016/j.therap.2026.07.002","url":null,"abstract":"<p><strong>Objective: </strong>To describe the implementation, certification and five-year experience of an ISO9001:2015-compliant quality management system (QMS) within a university hospital Department of Pharmacotoxicology encompassing pharmacovigilance, addictovigilance, toxicovigilance and telephone-based emergency response activities, and to analyse the benefits and limitations of this approach.</p><p><strong>Methods: </strong>The QMS was deployed from 2018 using a structured approach integrating context and stakeholder analysis, process mapping, documentation system formalisation, non-conformity management, internal and external audits, process and management reviews, and monitoring of quality indicators.</p><p><strong>Results: </strong>Initial ISO9001:2015 certification was obtained in January 2021, followed by two surveillance audits and recertification in February 2024. Over five years, 111 non-conformities were reported by 23 staff members, generating 214 improvement actions, of which 156 (73%) were completed. QMS implementation was accompanied by the deployment of structuring tools, including a dedicated operational software solution, and enabled continuity of activity during a major health crisis. Satisfaction surveys showed high levels of satisfaction among service users (clarity of information: 99.2%; quality of medical advice: 97.6%; response times: 95.1%) and regulatory authorities. No major risks were identified during audits.</p><p><strong>Conclusion: </strong>Implementing an ISO9001:2015-based QMS in a Pharmacotoxicology ward is both feasible and beneficial. It supports a robust and agile organisational framework, strengthens regulatory compliance, traceability and constitutes a key driver for institutional dialogue. This experience provides a transferable model for other vigilance structures.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148881396","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}