TherapiePub Date : 2024-07-01DOI: 10.1016/j.therap.2023.10.002
{"title":"Green tea and nadolol interaction: A risk of therapeutic inefficiency, a case report and extensive review","authors":"","doi":"10.1016/j.therap.2023.10.002","DOIUrl":"10.1016/j.therap.2023.10.002","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89719610","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}
TherapiePub Date : 2024-07-01DOI: 10.1016/j.therap.2023.10.001
{"title":"Apport des tests cutanés dans le cas d’un exanthème flexural et symétrique induit par la pristinamycine","authors":"","doi":"10.1016/j.therap.2023.10.001","DOIUrl":"10.1016/j.therap.2023.10.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135661106","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}
TherapiePub Date : 2024-07-01DOI: 10.1016/j.therap.2023.10.003
{"title":"Élaboration d’une activité éducative ciblée en addictologie : de la conception à l’utilisation dans les structures spécialisées de la région Normandie","authors":"","doi":"10.1016/j.therap.2023.10.003","DOIUrl":"10.1016/j.therap.2023.10.003","url":null,"abstract":"<div><h3>Objectif</h3><p>La réduction des risques et des dommages est un enjeu de santé publique et permet de considérer l’addiction comme une pathologie chronique dans laquelle les patients ont l’opportunité de devenir acteurs de leur prise en charge, philosophie de soins partagée avec l’éducation thérapeutique. Dans ce contexte, notre objectif est de développer un outil adapté aux populations de patients/usagers accueillies en structures spécialisées, répondant aux critères d’une activité éducative ciblée, pour leur permettre une meilleure compréhension et gestion de leur addiction aux opiacés au quotidien.</p></div><div><h3>Méthode</h3><p>Dans un cadre pluriprofessionnel, associant pharmaciens, médecins et infirmiers, une phase exploratoire a été conduite afin de cerner la thématique, le public cible et le format de l’outil. Puis, l’outil a été construit et validé avec l’ambition de répondre pédagogiquement aux problématiques rencontrées quotidiennement par les patients/usagers.</p></div><div><h3>Résultats</h3><p>L’outil pédagogique, dénommé « Le QUIZZ à moindre risque », comporte 51 questions catégorisées en 2 parties structurées sur la réduction des risques liés à la consommation des opiacés et aux médicaments de substitution. Centré sur les problématiques des patients/usagers, il permet de les accompagner vers une plus grande autonomie en santé et une meilleure qualité de vie, avec et malgré la maladie. Le format proposé en fait un outil librement consultable par les patients/usagers selon leurs pratiques et leurs besoins ; il peut également être utilisé dans des ateliers collectifs menés avec les soignants.</p></div><div><h3>Conclusion</h3><p>L’outil développé vise à (i) permettre aux consommateurs d’opiacés d’acquérir des compétences pour mieux gérer leur consommation et les risques encourus et (ii) renforcer la communication entre patients/usagers et soignants en leur offrant l’opportunité d’être acteurs de leur soin. L’outil est actuellement testé et évalué dans de nombreuses villes normandes et son optimisation permettra une amélioration dans la prise en soins à la hauteur des enjeux et des besoins.</p></div><div><h3>Objective</h3><p>Risk and damage reduction is a public health issue and allows to consider addiction as a chronic pathology in which patients have the opportunity to become actors of their own care, a philosophy shared with Therapeutic Education. In this context, our objective is to develop a tool adapted to the populations of patients/users in specialized structures, meeting the criteria of a Targeted Educational Activity, to allow them a better understanding and management of their addiction to opiates on a daily basis.</p></div><div><h3>Method</h3><p>In a multi-professional setting, involving pharmacists, doctors and nurses, an exploratory phase was conducted in order to identify the theme, the target population and the tool format. Then, the tool was built and validated with the ambition of responding pedagogically to ","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136152890","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":"[Balancing drug regulation and health democracy: The role of patient and healthcare professional advisors at the ANSM].","authors":"Patrick Maison, Trystan Bacon, Pascale Daynes, Christophe Decoene, Roseline Mazet, Thierry Vial, Stéphane Vignot, Laetitia Belgodère, Wahiba Oualikene-Gonin, Christelle Ratignier-Carbonneil","doi":"10.1016/j.therap.2024.06.002","DOIUrl":"https://doi.org/10.1016/j.therap.2024.06.002","url":null,"abstract":"<p><p>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. They are particularly involved when the analysis requires expertise that goes beyond the technical, scientific or regulatory aspects. They may also work with ANSM staff to explain certain processes and difficulties in the field. Advisors help to ensure that regulatory and/or scientific expertise is clear and consistent with user experience. In addition to their scientific and therapeutic aspects, medicines are also economic, social and political issues. Their regulation is therefore particularly affected by the need for health democracy. This requires the active participation of health professionals, patients and, more broadly, civil society in the decision-making process. Civil society is a space occupied by a wide range of actors who exert pressure from different ideological positions to influence the regulation of health products. In this context, taking into account a plurality of viewpoints in the regulation of health products is necessary and complex, but its operation can be facilitated by the collective efforts of the actors and the adaptation of organisations, such as the integration of advisors.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-06-22","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}
{"title":"COVACPREG, a French prospective cohort study of women vaccinated against COVID-19 during pregnancy.","authors":"Isabelle Lacroix, Anthony Caillet, Laurane Delteil, Hadjer Ameur, Nassima Padelli, Caroline Hurault-Delarue, Judith Cottin","doi":"10.1016/j.therap.2024.06.003","DOIUrl":"https://doi.org/10.1016/j.therap.2024.06.003","url":null,"abstract":"<p><p>The objective of this cohort study was to describe the French population of pregnant women vaccinated against coronavirus disease 2019 (COVID-19), their pregnancy outcomes and the health status of their newborns (malformation rate, neonatal diseases, etc.), and to proactively collect and analyze reported adverse reactions over time. We conducted a prospective study using an online questionnaire. Women vaccinated during pregnancy who wanted to participate were asked to complete an inclusion questionnaire (dates of pregnancy and vaccination COVID-19, etc.), a questionnaire on the potential occurrence of adverse reactions (time of onset, type of adverse reaction, etc.) of the vaccination, sent 1 month after the injection, and a final questionnaire on the outcome of the pregnancy and the health status of the child. A total of 938 women were prospectively included in this first French study. A total of 132 women reported having had at least 1 adverse reaction following vaccination during pregnancy (14.1%), including few 'serious' adverse reaction (5.3%). There were no signals of adverse reactions during continuous monitoring. Among the 938 pregnant women, 22.4% received the vaccination COVID-19 during the first trimester, 64.2% during the second and 33.4% during the third trimester (some women have had several injections in different trimesters). Among the 938 women, 4.3% developed gestational hypertension and 13.9% diabetes; 3.3% had intrauterine growth restriction and 7.8% threatened preterm delivery. These rates are comparable to those observed in the French general population. Among live births, the rate of preterm birth was 5.1%. We reported a prevalence of major malformations of 3.9%, which is comparable to that reported by European Surveillance of Congenital Anomalies (EUROCAT), with a rate of 3.5% of major malformations in the general population of mainland France. In conclusion, our study did not demonstrate any particular safety signals in the event of vaccination with a Covid-19 vaccine during pregnancy.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141601799","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":"What is the best source for searching drug with CIP codes in the French health reimbursement data system (SNDS) database?","authors":"Sylvain Couderc, Sabrina Crépin, Marc Labriffe, Caroline Monchaud, Hélène Roussel, Alexandre Garnier, Aurélie Prémaud, Claire Villeneuve, Clément Benoist, Jean-Baptiste Woillard, Pierre Marquet","doi":"10.1016/j.therap.2024.05.001","DOIUrl":"https://doi.org/10.1016/j.therap.2024.05.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.2,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141535349","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}
TherapiePub Date : 2024-06-05DOI: 10.1016/j.therap.2024.05.006
Louis Lebreton, Benjamin Hennart, Sarah Baklouti, Aurélien Trimouille, Jean-Christophe Boyer, Laurent Becquemont, Claire-Marie Dhaenens, Nicolas Picard
{"title":"[Pharmacogenetics of aminoglycoside ototoxicity: State of knowledge and practices - Recommendations of the Francophone Network of Pharmacogenetics (RNPGx)].","authors":"Louis Lebreton, Benjamin Hennart, Sarah Baklouti, Aurélien Trimouille, Jean-Christophe Boyer, Laurent Becquemont, Claire-Marie Dhaenens, Nicolas Picard","doi":"10.1016/j.therap.2024.05.006","DOIUrl":"https://doi.org/10.1016/j.therap.2024.05.006","url":null,"abstract":"<p><p>The administration of aminoglycosides can induce nephrotoxicity or ototoxicity, which can be monitored through pharmacological therapeutic drug monitoring. However, there are cases of genetic predisposition to ototoxicity related to the MT-RNR1 gene, which may occur from the first administrations. Pharmacogenetic analysis recommendations have recently been proposed by the Clinical Pharmacogenetics Implementation Consortium (CPIC). The Francophone Pharmacogenetics Network (RNPGx) provides a bibliographic synthesis of this genetic predisposition, as well as professional recommendations. The MT-RNR1 gene codes for mitochondrial 12S rRNA, which constitutes the small subunit of the mitochondrial ribosome. Three variants can be identified: the variants m.1555A>G and m.1494C>T of the MT-RNR1 gene have a 'high' level of evidence regarding the risk of ototoxicity. The variant m.1095T>C has a 'moderate' level of evidence. The search for these variants can be performed in the laboratory if the administration of aminoglycosides can be delayed after obtaining the result. However, if the treatment is urgent, there is currently no rapid test available in France (a 'point-of-care' test is authorized in Great Britain). RNPGx considers: (1) the search for the m.1555A>G, m.1494C>T variants as 'highly recommended' and the m.1095T>C variant as 'moderately recommended' before the administration of an aminoglycoside (if compatible with the medical context). It should be noted that the level of heteroplasmy detected does not modify the recommendation; (2) pharmacogenetic analysis is currently not feasible in situations of short-term aminoglycoside administration, in the absence of an available analytical solution (rapid test to be evaluated in France); (3) the retrospective analysis in case of aminoglycoside-induced ototoxicity is 'recommended'; (4) analysis of relatives is 'recommended'. Through this summary, RNPGx proposes an updated review of the MT-RNR1-aminoglycoside gene-drug pair to serve as a basis for adapting practices regarding pharmacogenetic analysis related to aminoglycoside treatment.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141321705","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}
TherapiePub Date : 2024-05-28DOI: 10.1016/j.therap.2024.05.004
Jean-Joseph Bendjilali-Sabiani, Céline Eiden, Margot Lestienne, Sabrina Cherki, David Gautre, Thomas Van den Broek, Olivier Mathieu, Hélène Peyrière
{"title":"Isotonitazene, a synthetic opioid from an emerging family: The nitazenes.","authors":"Jean-Joseph Bendjilali-Sabiani, Céline Eiden, Margot Lestienne, Sabrina Cherki, David Gautre, Thomas Van den Broek, Olivier Mathieu, Hélène Peyrière","doi":"10.1016/j.therap.2024.05.004","DOIUrl":"https://doi.org/10.1016/j.therap.2024.05.004","url":null,"abstract":"<p><p>From 2019, in the United States and Europe, the synthetic opioid market has diversified with the appearance of the 2-benzylbenzimidazole family, commonly named \"nitazenes\". In vitro studies show that these synthetic opioids have much higher affinities on μ-opioid receptors: 100 times more than morphine, and slightly higher than fentanyl for isotonitazene, increasing the risk of overdose. In south of France, isotonitazene (IZN) was identified for the first time in March 2023. In this context, there were 9 reports concerning the use of IZN in the south of France over a short period (March-April 2023), with identification of IZN in 4 cases and suspicion in others. They concerned 6 men and 3 women, with a mean age of 44.9±2 years. When available (2 cases), the product had been purchased from a dealer. IZN was identified on sample in 2 cases of overdose. Isotonitazene was also identified in biological samples in 2 cases: 1 case of overdose and coma requiring hospitalization with a favorable outcome (urinary analysis), and a death with post-mortem identification. This was the first identification of this product in France. The immediate broadcast of the alert limited the risks for users and made it possible to quickly inform regional and national health authorities. IZN is under intensive surveillance by the EMCDDA and classified as a narcotic in France since 2021. The analysis of the literature made it possible to identify cases of overdoses requiring very high doses of naloxone and deaths. The emergence of these synthetic opioids constitutes an important signal, due to their superior effects to heroin, their incomplete response to naloxone and the current difficulty in identifying them (devices for analyzing products in the reduction of risks, toxicology laboratories).</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":null,"pages":null},"PeriodicalIF":2.6,"publicationDate":"2024-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141284813","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}