Therapie最新文献

{"title":"Reintroduction of cotrimoxazole in a Stevens-Johnson case with other antibacterial sulfonamide (sulfadiazine) among suspects.","authors":"Ilaria Matei, Valérie Beaulieu, Camille Ollivier, Bénédicte Lebrun-Vignes, Kamar Bel Hareth, Saskia Ingen-Housz-Oro, Haudrey Assier","doi":"10.1016/j.therap.2025.03.002","DOIUrl":"https://doi.org/10.1016/j.therap.2025.03.002","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143796262","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":"Perceptions of contribution of the placebo effects to drug efficacy in community pharmacy practice: A cross-sectional survey.","authors":"Joey Fournier, Leo Druart, Marie Allier, Matthieu Roustit","doi":"10.1016/j.therap.2025.02.015","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.015","url":null,"abstract":"<p><strong>Introduction: </strong>The placebo effect, a well-documented phenomenon in clinical practice, remains complex and multifaceted. While the perception of placebo effects has been assessed among various healthcare professionals, pharmacists - recognized experts in treatment effects and effectiveness - have not been specifically studied. This cross-sectional study aimed to evaluate the knowledge and perceptions of healthcare professionals working in community pharmacies in France, Switzerland, and Belgium regarding placebo effects.</p><p><strong>Material and methods: </strong>A self-administered questionnaire was distributed to pharmacists, pharmacy technicians, and community pharmacy students between September and December 2023. The questionnaire used numeric scales (0-10) to evaluate knowledge of placebo effects, underlying mechanisms, influencing factors, and demographic details.</p><p><strong>Results: </strong>A total of 377 responses were collected, primarily from female pharmacists practicing in France. Respondents demonstrated a strong theoretical understanding of placebo effects (n=302; 80%). Among 12 proposed contextual factors influencing placebo effects, the three most highly rated were patient-related: patient expectations and preferences, past experiences, and beliefs or representations about their condition. Perceptions of placebo effects varied significantly according to medication type, with median scores of 1 [0-3] for treatments with demonstrated efficacy, 3 [1-5] for conventional medicines without demonstrated efficacy, and 6 [4-9] for complementary and alternative medicines (CAM). This suggests that placebo-related efficacy is perceived as more associated with the type of medication (e.g., CAM vs. conventional medicines) rather than the presence or absence of demonstrated efficacy.</p><p><strong>Conclusion: </strong>Pharmacists showed a solid theoretical grasp of placebo effects but seem to associate placebo-related efficacy more strongly with medication type than evidence of efficacy. These findings highlight the need to raise awareness among pharmacy-based healthcare professionals about treatment efficacy to improve clinical practice and patient care.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143773398","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":"Unexpected haloperidol-induced yawning while neuroleptic switch, paradoxical reaction or dopaminergic supersensitivity? A case report.","authors":"Jacques Hamard, François Montastruc, Dalil Boulefaa, Julie Haybrard, Julien Li","doi":"10.1016/j.therap.2025.02.014","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.014","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143796310","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":"Cutaneous adverse drug reactions induced by anticonvulsants: Proposal for allergological work-up and contraindications.","authors":"Saskia Ingen-Housz-Oro, Paola Sanchez-Pena, Bénédicte Lebrun-Vignes, Kevin Bihan, Claire Bernier, Brigitte Milpied, Haudrey Assier","doi":"10.1016/j.therap.2025.02.013","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.013","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143721564","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":"Clinical consequences of varenicline shortage: A study on the French national pharmacovigilance database.","authors":"Amélie Lepert, Delphine Bourneau-Martin, Bénédicte Lebrun-Vignes, Alexandra Gentil, Pierre Brunel, Ivan Berlin, Marie Briet","doi":"10.1016/j.therap.2025.02.009","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.009","url":null,"abstract":"<p><strong>Objectives: </strong>Varenicline is a smoking cessation therapy included in the World Health Organization (WHO) model list of essential medicines. In May 2021, the presence of N-nitroso-varenicline, a carcinogenic agent, was detected in varenicline tablets above the limits determined by the European Medicine Agency (EMA), leading to batches being recalled and causing a shortage of this drug. The aim of this study was to use pharmacovigilance data to evaluate the clinical consequences of the shortage of varenicline.</p><p><strong>Methods: </strong>Data were extracted from the French PharmacoVigilance Database using the following terms: \"varenicline (tartrate of)\", \"varenicline\" and \"tartrate of varenicline\" as the suspected, interactive, or concomitant medication from 4 April 2021 to 17 March 2023. Each case was reviewed by a pharmacovigilance expert to select only cases that involved a varenicline shortage.</p><p><strong>Results: </strong>Among the 32 included cases, the reported adverse effects were: smoking relapse (n=21), tobacco cessation failure (n=7) and tobacco withdrawal syndrome (n=2). Most of the patients presented a high level of tobacco dependence. Before the introduction of varenicline, these smokers consumed a median of 20 cigarettes per day. They did not smoke while receiving varenicline. After the shortage, the daily cigarette consumption went up to 10 in all patients treated with nicotine replacement therapy (NRT) and up to 20 when NRT was not used.</p><p><strong>Discussion: </strong>In the context of a varenicline shortage, the pharmacovigilance data confirmed the risk of smoking relapse and/or cessation failure in patients with a strong addiction to cigarettes. Given the role of smoking exposure in respiratory, cancer and cardiovascular risk, it is vitally important that the availability of this medicine is ensured. Solutions, such as the importation of alternatives produced by other brands that pass the tests for impurity quantification, may prevent the risk in this context.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143721562","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":"[Pharmacovigilance notification by dental surgeons in France: A ten-year analysis of the French database].","authors":"Antonin Vagnet, Hélène Peyrouzet, Viktoryia Prontskus, Corinne Guihard, Lucie Vettoretti, Marie Blanche Valnet Rabier","doi":"10.1016/j.therap.2025.02.011","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.011","url":null,"abstract":"<p><strong>Introduction: </strong>Dentists, in their practice, bear responsibility for the benefits and the risks associated with the medications they prescribe. Their code of ethics grants them the freedom to prescribe while encouraging them to limit their interventions to what is strictly necessary for the quality and effectiveness of care. Furthermore, dentists also face ontological adverse effects resulting from medications they did not personally prescribe. A study based on the analysis of cases recorded over ten years in the national pharmacovigilance database (BNPV) is relevant for assessing the current state of pharmacovigilance reports submitted by dentists.</p><p><strong>Methods: </strong>We conducted a retrospective analysis of the cases recorded in the BNPV, reported by dentists between 01/01/2013 and 31/12/2023.</p><p><strong>Results: </strong>Over 10 years, 509 reports were recorded, representing 0.06% of all registered cases. These reports were divided into three main groups. Among the 509 declarations, 24.8% were cases associated with medications used in the field of dentistry, such as anti-inflammatory drugs, antibiotics, local anaesthetics, and local antiseptics. In total, 35.2% were cases of odontological adverse effects, such as jaw osteonecrosis, gingival hypertrophy, and oral ulcers. Finally, 28.3% of the cases involved reports of adverse effects related to coronavirus disease 2019 (COVID-19) vaccination, which began in late December 2020.</p><p><strong>Conclusion: </strong>The low rate of pharmacovigilance reports by dentists in France over the past ten years highlights an issue of underreporting of adverse effects in dental practice. Recent literature emphasizes the importance of pharmacovigilance reporting in the field of dentistry, particularly concerning odontological effects.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143721561","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":"Evaluation of efficacy and tolerance of intravesical amphotericin B irrigation for the management of Candiduria.","authors":"Zahoua Kartit, Maud Hulin, Dominique Hettler, Antoine Huguenin, Morgane Bonnet, Yohan N'Guyen","doi":"10.1016/j.therap.2025.02.010","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.010","url":null,"abstract":"<p><strong>Introduction: </strong>Candiduria, is becoming increasingly common among hospitalized and immunocompromised patients. This infection poses a therapeutic challenge due to the rise in fluconazole resistance among Candida species. When fluconazole is unsuitable due to resistance or drug interactions, amphotericin B (AmB) is recommended. However, AmB's systemic use is limited by nephrotoxicity, which has led to interest in intravesical (bladder-administered) AmB.</p><p><strong>Methods: </strong>A retrospective study was conducted at Reims University Hospital on adult patients treated with intravesical AmB. Patient demographics, infection characteristics, and treatment details were extracted from medical records. Efficacy was determined by the absence of candiduria or rehospitalization, and renal safety was evaluated through serum creatinine and renal clearance before and after treatment. Adverse effects were graded by severity.</p><p><strong>Results: </strong>Sixteen patients were included (10 female patients (62.5%), mean age 69.8±15 years). Eight patients (50.0%) were admitted in urology department and diabetes mellitus was present in 9 patients (56.2%). Candida glabrata, resistant to fluconazole, was the most frequently isolated organism. Intravesical AmB was administered at a standard dose of 50mg diluted in 1 liter of sterile water, delivered over 24hours among almost all patients. Two patients were rehospitalized. Among patients with follow-up urine cultures, 66% (4 out of 6) achieved candiduria eradication. Two patients reported minor adverse effects, including mild catheter-related discomfort. No significant increase of serum creatinine level was observed after treatment.</p><p><strong>Discussion and conclusion: </strong>Intravesical AmB appear effective and safe for treating fluconazole-resistant candiduria, especially in high-risk, elderly patients. While promising, these findings are based on a small sample, highlighting the need for larger studies with prospective design to further elucidate the optimal management strategies for candiduria in vulnerable patients.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143744027","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":"[Deleterious impact of a non-steroidal anti-inflammatory taken for fever or acute pain in case of streptococcal infection].","authors":"Annie-Pierre Jonville-Bera, Joëlle Micallef","doi":"10.1016/j.therap.2025.02.012","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.012","url":null,"abstract":"<p><p>For several years, regional pharmacovigilance centers have been warning about the risk of worsening bacterial skin or lung infections caused by Streptococcus pyogenes or Pneumococcus after taking non-steroidal anti-inflammatory drugs (NSAIDs), particularly ibuprofen. A new report submitted to the French Medicines Agency in 2024 documented 216 cases of serious bacterial infections (162 with ibuprofen, 54 with ketoprofen) over 4.5 years following the use of NSAIDs for fever or acute pain. This represents about 21% of serious adverse events with ibuprofen (8% with ketoprofen). Streptococcal infections were most common with ibuprofen (62% of serious bacterial infections; 44% with ketoprofen). These streptococcal infections were invasive (97%) and included severe sepsis/toxic shock, pleuropneumopathy, meningitis/meningoencephalitis and necrotizing dermohypodermatitis. Pharmacoepidemiological studies all suggest an association between NSAID exposure and an increased risk of pleuropulmonary complications, with estimated risks ranging from 1.8 to 8. Several mechanistic data also suggest a specific adverse effect on the severity of invasive streptococcal infections through a specific intrinsic effect of NSAIDs on the enhancement of streptococcal diffusion (via vimentin). Experimental studies in animals have also demonstrated this risk, even when NSAIDs are combined with antibiotics. In conclusion, in the presence of a streptococcal infection, whether diagnosed or not, taking an NSAID for fever or acute pain, even for a short time and even in association with an antibiotic, is a risky practice. It encourages the development of a more serious streptococcal infection, not only by delaying management of the infection, but more importantly by promoting the dissemination of the streptococcus. As invasive S. pyogenes infections are a real public health problem, any potential risk factor for aggravation must be taken into account.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143670947","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":"Intravitreal vascular endothelial growth factor inhibitors and cardiovascular adverse drug reactions: Added value of the data of the French pharmacovigilance spontaneous reporting assessment.","authors":"Aurélie Bobet, Leila Chebane, Annie-Pierre Jonville-Bera, Marina Babin, Thomas Soeiro, Haleh Bagheri","doi":"10.1016/j.therap.2025.02.008","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.008","url":null,"abstract":"<p><strong>Aim: </strong>To describe cardiovascular adverse reactions reported after intravitreal injections of vascular endothelial growth factor inhibitors (I-VEGF) as registered in the French Pharmacovigilance Database (FPVDB).</p><p><strong>Methods: </strong>This retrospective study assessed spontaneous adverse drug reactions reported to the French pharmacovigilance system and registered in the FPVDB from April 2007 to June 2023. Eligible cases of thromboembolic events and arterial hypertension associated with three I-VEGFs (aflibercept, ranibizumab and bevacizumab) were selected.</p><p><strong>Results: </strong>A total of 127 cases were included (83 for ranibizumab, 37 for aflibercept, and 7 for bevacizumab), including 21 cases of arterial hypertension and 106 cases of thromboembolic events. The median onset time for thromboembolic events ranged from 1 to 119days following injection, and from 0 to 30days for arterial hypertension. The median number of injections ranged from 1 to 24 before the occurrence of an adverse drug reaction. In 23% of cases, no risk factor was found for the occurrence of a cardiovascular or thromboembolic adverse event. In two cases, a positive rechallenge was documented.</p><p><strong>Conclusion: </strong>The rational use of pharmacological data, some relevant spontaneous reports and some pharmacoepidemiological studies are a prompt to health professionals to take precautions in patients with risk factors requiring I-VEGF. However, European Summaries of Product Characteristics do not give a clear picture to healthcare professionals concerning the precautions to take for patients with risk factors.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143664491","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":"Vaccines and the risk of Guillain-Barré syndrome: A French pharmacovigilance analysis.","authors":"Marie Gligorov, Bénédicte Lebrun-Vignes, Kamel Masmoudi, Thierry Vial, Helga Junot, Valérie Pourcher, Sophie Demeret, Nicolas Weiss, Kevin Bihan","doi":"10.1016/j.therap.2025.02.007","DOIUrl":"https://doi.org/10.1016/j.therap.2025.02.007","url":null,"abstract":"<p><strong>Aims: </strong>Guillain-Barré syndrome (GBS) is a rare autoimmune-mediated disease that can occur in a post-vaccination context. During the vaccination surveillance program of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, reports of GBS as a possible adverse effect (AE) of SARS-CoV-2 vaccines have been reported. Our aim was to describe post-vaccine reports of GBS whatever the vaccine used.</p><p><strong>Methods: </strong>Data were obtained from the French pharmacovigilance database from inception (1 January 1985) to 1st March 2022. Reports were analyzed according to the French causality assessment method but only reports with a time to onset from the beginning of the treatment and the first symptoms occurrence of less than 4weeks were included in our analysis, in accordance to the chronological criteria of the Brighton criteria.</p><p><strong>Results: </strong>Three hundred and seventy-five (375) reports of GBS according to these selection criteria were retained for analysis. The data indicate a higher proportion of men (59%), with a median age of 54years and a median time-to-onset after vaccination of 12days. Around 45% of the reports were recorded with SARS-CoV-2 vaccines of which 68% involved post-mRNA vaccines and more precisely 56% post-tozinameran.</p><p><strong>Conclusion: </strong>This study suggests that Guillain-Barré syndrome may be a rare but potentially severe adverse event that can occur in the first few weeks after vaccination whatever its nature. Even if a vaccine was injected in the weeks preceding the first signs of GBS, it is essential to perform a complete etiological assessment (search for bacterial or viral infection, particularly Campylobacter jejuni, etc.) in order to rule out another cause before considering its role in the onset of GBS. Continued pharmacovigilance survey of marketed vaccines is necessary to update or even harmonize its SmPCs.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639828","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}