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Translation of the REMEDI[e]S (Review of potentially inappropriate MEDIcation pr[e]scribing in Seniors) explicit criteria into seminatural language for use in prescription support systems: A multidisciplinary consensus 将 REMEDI[e]S(审查老年人潜在的不当医疗行为)的明确标准翻译成半自然语言,用于处方支持系统:多学科共识。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-07-01 DOI: 10.1016/j.therap.2024.09.002
Romane Freppel , Anaïs Barbier , Mathilde Dambrine , Laurine Robert , Chloé Rousselière , Estel Cuneo , Pascal Odou , Sophie Gautier , Jean-Baptiste Beuscart , Marie-Laure Laroche , Bertrand Décaudin

Background

By recovering data in an ordered manner and at the right time, clinical decision support systems (CDSSs) are designed to help healthcare professionals make decisions that improve patient care.

Objectives

The aim of the present study was to translate the REMEDI[e]s tool's explicit criteria, France's first reference list of potentially inappropriate drugs for the elderly, into seminatural language, in order to implement these criteria as alert rules and then enable their computer coding in a CDSS.

Methods

This work was carried out at Lille University Hospital by a team of clinical pharmacists with expertise in the use of pharmaceutical decision support systems, in collaboration with the authors of the REMEDI[e]s tool. A total of 3 multi-professional consensus meetings were required to discuss the construction of each rule in seminatural language and the coding choices.

Results

All REMEDIES criteria (n = 104) were translated into seminatural language. This study is the first to have translated the 104 REMEDI[e]s explicit criteria into seminatural language.

Conclusions

One of the study's strengths relates to the close collaboration between the authors of the REMEDI[e]s tool and experts in CDSS programming rules; this ensured the exactitude of the seminatural language translations and limited (mis)interpretations.
背景:临床决策支持系统(CDSS)以有序的方式在适当的时间恢复数据,旨在帮助医疗保健专业人员做出改善患者护理的决策:本研究的目的是将REMEDI[e]s工具的明确标准--法国第一份老年人潜在不适当药物参考清单--翻译成半自然语言,以便将这些标准作为警报规则实施,然后将其编码到CDSS中:这项工作由里尔大学医院的一个临床药剂师团队与 REMEDI[e]s 工具的作者合作完成,该团队拥有使用药物决策支持系统的专业知识。共召开了 3 次多专业共识会议,讨论如何用半自然语言构建每条规则以及编码选择:所有 REMEDIES 标准(n=104)均已翻译成半自然语言。本研究是首次将104条REMEDI[e]s明确标准翻译成半自然语言:本研究的优势之一在于 REMEDI[e]s 工具的作者与 CDSS 编程规则专家之间的密切合作;这确保了半自然语言翻译的准确性和有限的(错误)解释。
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引用次数: 0
Impact délétère d’un anti-inflammatoire non stéroïdien pris pour fièvre ou douleur aiguë en cas d’infection streptococcique [在链球菌感染的情况下,用于发烧或急性疼痛的非甾体抗炎药的有害影响]。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-07-01 DOI: 10.1016/j.therap.2025.02.012
Annie-Pierre Jonville-Bera , Joëlle Micallef
Depuis plusieurs années, les centres régionaux de pharmacovigilance alertent sur le risque d’aggravation des infections bactériennes cutanées ou pulmonaires à streptocoques pyogènes ou à pneumocoques, après la prise d’anti-inflammatoires non stéroïdiens (AINS), notamment l’ibuprofène. Une nouvelle expertise présentée à l’Agence du médicament en 2024 a colligé en 4,5 ans, 216 cas d’infections bactériennes graves (162 avec ibuprofène, 54 avec kétoprofène) après la prise d’AINS pour fièvre ou douleur aiguë, soit environ 21 % des effets indésirables graves avec l’ibuprofène (8 % pour le kétoprofène). Les infections streptococciques étaient majoritaires pour l’ibuprofène (62 % des cas d’infection bactérienne graves ; 44 % pour le kétoprofène). Ces infections streptococciques étaient invasives (97 %), à type de sepsis sévère/choc toxinique, de pleuropneumopathie, de méningite/méningoencéphalite et de dermohypodermite nécrosante. Les études de pharmaco-épidémiologie suggèrent toute une association entre l’exposition à un AINS et une augmentation du risque de complications pleuropulmonaires avec une estimation du risque compris entre 1,8 et 8. Plusieurs données mécanistiques sont également en faveur d’un effet délétère spécifique sur la gravité des infections invasives streptococciques, par un effet propre, intrinsèque des AINS sur l’amplification de la diffusion des streptocoques (via la vimentine). Des études expérimentales, chez l’animal, démontrent également ce risque, même quand l’AINS est associé à un antibiotique. En conclusion, en présence d’une infection streptococcique, qu’elle soit diagnostiquée ou non, la prise d’un AINS pour fièvre ou douleur aiguë, même sur une courte durée, et même associée à un antibiotique est une pratique à risque. Elle favorise l’évolution vers une infection streptococcique plus grave, non seulement en retardant la prise en charge de l’infection, mais surtout en favorisant la dissémination du streptocoque. Dans la mesure où les infections invasives à Streptococcus pyogenes sont un réel problème de santé publique, tout facteur de risque potentiel d’aggravation doit être pris en compte.
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, ple
几年来,区域药物警戒中心一直在警告服用非甾体抗炎药(NSAIDs),特别是布洛芬后,由化脓性链球菌或肺炎球菌引起的细菌性皮肤或肺部感染恶化的风险。2024年提交给法国药品管理局的一份新报告记录了216例严重细菌感染(162例使用布洛芬,54例使用酮洛芬),在使用非甾体抗炎药治疗发烧或急性疼痛的4.5年内。这约占布洛芬严重不良事件的21%(酮洛芬为8%)。链球菌感染在布洛芬中最常见(62%的严重细菌感染;44%服用酮洛芬)。这些链球菌感染是侵袭性的(97%),包括严重败血症/中毒性休克、胸膜肺炎、脑膜炎/脑膜脑炎和坏死性皮炎。药物流行病学研究均表明,非甾体抗炎药暴露与胸膜肺并发症风险增加之间存在关联,估计风险范围为1.8至8。一些机制数据也表明,通过非甾体抗炎药增强链球菌扩散(通过vimentin)的特定内在效应,对侵袭性链球菌感染的严重程度有特定的不利影响。动物实验研究也证明了这种风险,即使非甾体抗炎药与抗生素联合使用也是如此。总之,在链球菌感染的情况下,无论是否确诊,在发烧或急性疼痛时服用非甾体抗炎药,即使是很短的时间,甚至与抗生素有关,都是一种危险的做法。它不仅延误了感染的治疗,而且更重要的是促进了链球菌的传播,从而助长了更严重的链球菌感染的发展。由于侵袭性化脓性链球菌感染是一个真正的公共卫生问题,任何潜在的恶化风险因素都必须考虑在内。
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引用次数: 0
Impact d’une rupture de dronabinol sur une population de patients douloureux chroniques : étude observationnelle rétrospective [大麻酚缺乏对慢性疼痛患者人群的影响:一项回顾性观察研究]。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-07-01 DOI: 10.1016/j.therap.2024.12.010
Salomé Winckel, Laurie Ferret, Laure Dujardin, Amélie Boursier

Objectif

Une rupture d’approvisionnement en dronabinol a eu lieu entre décembre 2023 et février 2024 imposant aux patients douloureux chroniques d’interrompre ce traitement. Nous avons évalué l’impact de cette pénurie sur les patients de notre établissement.

Méthodes

Une étude observationnelle rétrospective a été menée auprès des patients traités par dronabinol. Les données recueillies comprenaient des données sociodémographiques, pharmacologiques et cliniques. L’intensité et la description de la douleur, l’intensité des autres dimensions de la douleur (humeur, relation aux autres…) et la qualité du sommeil ont été recueillis avant la rupture (posologie de dronabinol équilibrée, M0) et à la fin de la rupture (dronabinol arrêté depuis plusieurs semaines, M3). Le ressenti du patient de l’évolution de son état de santé a été recueilli à la fin de la rupture.

Résultats

Une dégradation de leur état de santé a été rapportée par 86 % des patients après 3 mois de rupture. L’intensité de la douleur et son interférence avec la vie quotidienne des patients a augmenté de façon significative. Le sommeil des patients s’est significativement dégradé. Le nombre de patients avec des douleurs permanentes a été multiplié par 5 (n = 2 à M0 et n = 10 à M3). Le nombre de patients avec plus de 20 crises douloureuses par 24 heures a été multiplié par 2 (n = 2 à M0 et n = 4 à M3).

Conclusion

Bien que les données concernant l’efficacité du dronabinol soient aujourd’hui limitées, cette rupture d’approvisionnement a eu des conséquences cliniques négatives chez nos patients. Les pénuries de médicaments se multipliant ces dernières années, la commercialisation de nouvelles spécialités et donc la présence d’alternatives thérapeutiques pourrait permettre chez ces patients douloureux chroniques réfractaires, de diminuer l’impact clinique d’une éventuelle nouvelle rupture de dronabinol.

Objective

A supply shortage of dronabinol occurred between December 2023 and February 2024, forcing chronic pain patients to discontinue this treatment. We assessed the impact of this shortage on patients in our hospital.

Method

A retrospective observational study of patients treated with dronabinol was conducted. Collected data included socio-demographic, pharmacological and clinical data. Pain intensity and its interference, the intensity of other pain dimensions (mood, relationship with others, etc.) and quality of sleep were collected before discontinuation (dronabinol dosage balanced, M0) and at the end of discontinuation (dronabinol stopped for several weeks, M3). The patient's perception of his state of health evolution was collected at the end of the shortage.

Results

Health deterioration was repo
目的:在2023年12月至2024年2月期间,屈大麻酚的供应短缺,迫使慢性疼痛患者停止这种治疗。我们评估了这种短缺对我们医院病人的影响。方法:对屈大麻酚治疗的患者进行回顾性观察研究。收集的资料包括社会人口学、药理学和临床资料。收集停药前(屈大麻酚剂量平衡,M0)和停药结束时(屈大麻酚停药数周,M3)疼痛强度及其干扰、其他疼痛维度(情绪、与他人关系等)强度、睡眠质量。在短缺结束时收集患者对其健康状况演变的感知。结果:86%的患者在破裂3个月后出现健康状况恶化。疼痛强度及其对患者日常生活的干扰明显增加。患者睡眠明显恶化。永久性疼痛患者数量增加了5倍(M0时n=2, M3时n=10)。每24小时疼痛发作超过20次的患者数量增加2倍(M0时n=2, M3时n=4)。结论:虽然关于屈大麻酚有效性的数据目前有限,但这种供应中断已经对我们的患者产生了负面的临床后果。随着近年来药物短缺的成倍增加,新专业的市场营销和治疗替代方案的可用性可以帮助减少这些难治性慢性疼痛患者可能出现的新的屈大麻酚短缺的临床影响。
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引用次数: 0
[ISO 9001: 2015 certification of the clinical trial unit of a university hospital center]. [iso9001: 2015大学医院中心临床试验单元认证]。
IF 2.2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-06-26 DOI: 10.1016/j.therap.2025.06.004
Tristan Pillot, Anas Gahbiche, Xavier Duval, Vanessa Bloch, Aude Jacob

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

目的:临床研究领域在法国的医疗机构中不断发展。然而,这种发展不应以牺牲研究质量或参与研究项目的患者的安全为代价。描述lariboisi医院- fernand Widal (unit pharmaceutique des essais cliniques de l'hôpital lariboisi - fernand Widal UPEC)药物临床试验单元根据ISO 9001: 2015标准进行质量持续改进的质量管理体系认证过程。方法:本认证项目由UPEC所属医科大学系发起,由一名质量保证官员领导,一名质量顾问支持,由UPEC团队成员执行。最初的审计提供了一份状态报告,计划进度表通过设定截止日期来组织整个过程。结果:通过识别与UPEC活动相关的内部和外部问题、利益相关方以及风险和机会,我们于2023年9月获得了本部门临床试验产品药品管理认证。此外,相关监控指标的制定允许对质量体系管理(QMS)的有效性进行评价。最后,基于初始审核报告结论的行动优先级使有效进展成为可能,从而在21个月内实现了符合ISO 9001: 2015标准的质量管理体系。结论:因此,获得认证代表了一种巨大的经验,是整个团队提供的大量工作的高潮,也是一种外部认可,有利于通过未来的合作伙伴关系发展这项活动。
{"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}
引用次数: 0
[Case report of a lethal voluntary drug intoxication with mirtazapine and venlafaxine complicated with a massive pharmacobezoar]. [一例米氮平和文拉法辛自发性药物中毒合并大量药物苯唑致死病例报告]。
IF 2.2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-06-25 DOI: 10.1016/j.therap.2025.06.005
Romain Batton, Fabien Lamoureux, Marion Beuzelin, Jean-Philippe Rigaud, Antoine Marchalot
{"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}
引用次数: 0
Preventing the risk of tuberculosis with teriflunomide: Is pre-treatment screening necessary? 用特立氟米特预防结核病风险:治疗前筛查有必要吗?
IF 2.2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-06-23 DOI: 10.1016/j.therap.2025.06.003
Marlène Damin-Pernik, Emilie Mayer, Anne Dautriche, Laure Mazzola, Marie-Noelle Beyens, Elisabeth Botelho-Nevers
{"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}
引用次数: 0
Rituximab-induced subcutaneous sarcoidosis in a patient with refractory pemphigus vulgaris. 难治性寻常型天疱疮患者的利妥昔单抗诱发皮下结节病1例。
IF 2.2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-06-19 DOI: 10.1016/j.therap.2025.06.002
Maha Lahouel, Yosr Yousfi, Amal Hamdi, Neila Fathallah, Sarra Saad, Badreddine Sriha, Najet Ghariani, Mohamed Denguezli
{"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}
引用次数: 0
Retinal venous occlusion in drug-induced lupus. 药物性狼疮的视网膜静脉阻塞。
IF 2.2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-05-21 DOI: 10.1016/j.therap.2025.05.003
Adrien Blanc, Charles Khouri, Laurence Bouillet, Christophe Chiquet
{"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}
引用次数: 0
COVACPREG, a French prospective cohort study of women vaccinated against COVID-19 during pregnancy COVACPREG 是一项法国前瞻性队列研究,研究对象是孕期接种 COVID-19 疫苗的妇女。
IF 2.2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-05-01 DOI: 10.1016/j.therap.2024.06.003
Isabelle Lacroix , Anthony Caillet , Laurane Delteil , Hadjer Ameur , Nassima Padelli , Caroline Hurault-Delarue , Judith Cottin
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.
这项队列研究的目的是描述法国接种冠状病毒病2019(COVID-19)疫苗的孕妇群体、她们的妊娠结局和新生儿的健康状况(畸形率、新生儿疾病等),并主动收集和分析一段时间内报告的不良反应。我们使用在线问卷进行了一项前瞻性研究。要求在怀孕期间接种疫苗并希望参与研究的妇女填写一份纳入问卷(怀孕日期和接种 COVID-19 疫苗的日期等)、一份在注射疫苗 1 个月后发出的关于接种疫苗后可能出现的不良反应(发病时间、不良反应类型等)的问卷,以及一份关于妊娠结局和婴儿健康状况的最终问卷。共有 938 名妇女被纳入了这项法国的首次研究。共有 132 名妇女报告在怀孕期间接种疫苗后至少出现过一次不良反应(14.1%),其中包括少数 "严重 "不良反应(5.3%)。在持续监测过程中未发现不良反应信号。在 938 名孕妇中,22.4% 在怀孕前三个月接种了 COVID-19,64.2% 在怀孕后三个月接种,33.4% 在怀孕后三个月接种(有些孕妇在不同的三个月接种了几次)。在 938 名妇女中,4.3% 患有妊娠高血压,13.9% 患有糖尿病;3.3% 患有胎儿宫内生长受限,7.8% 可能会早产。这些比率与在法国普通人群中观察到的比率相当。在活产婴儿中,早产率为 5.1%。我们报告的重大畸形发生率为 3.9%,与欧洲先天性畸形监测中心(EUROCAT)的报告相当,法国本土普通人群的重大畸形发生率为 3.5%。总之,我们的研究并未显示孕期接种 Covid-19 疫苗会产生任何特殊的安全信号。
{"title":"COVACPREG, a French prospective cohort study of women vaccinated against COVID-19 during pregnancy","authors":"Isabelle Lacroix ,&nbsp;Anthony Caillet ,&nbsp;Laurane Delteil ,&nbsp;Hadjer Ameur ,&nbsp;Nassima Padelli ,&nbsp;Caroline Hurault-Delarue ,&nbsp;Judith Cottin","doi":"10.1016/j.therap.2024.06.003","DOIUrl":"10.1016/j.therap.2024.06.003","url":null,"abstract":"<div><div><span><span>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 </span>health status<span><span> of their newborns (malformation rate, neonatal diseases, etc.), and to proactively collect and analyze reported </span>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 </span></span>vaccination<span> 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<span><span> and 13.9% diabetes; 3.3% had intrauterine growth restriction and 7.8% threatened </span>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.</span></span></div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 271-278"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","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}
引用次数: 0
Elexacaftor/tezacaftor/ivacaftor induced liver enzymes abnormalities in breastfed infants: A series of 3 cases 依来卡夫托/替扎卡夫托/依瓦卡夫托诱发母乳喂养婴儿肝酶异常:3例系列病例。
IF 2.2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-05-01 DOI: 10.1016/j.therap.2024.08.001
Sandrine Bergeron , Camille Audousset , Gurvan Bourdon , Charles Garabedian , Sophie Gautier
{"title":"Elexacaftor/tezacaftor/ivacaftor induced liver enzymes abnormalities in breastfed infants: A series of 3 cases","authors":"Sandrine Bergeron ,&nbsp;Camille Audousset ,&nbsp;Gurvan Bourdon ,&nbsp;Charles Garabedian ,&nbsp;Sophie Gautier","doi":"10.1016/j.therap.2024.08.001","DOIUrl":"10.1016/j.therap.2024.08.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 3","pages":"Pages 341-343"},"PeriodicalIF":2.2,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142296166","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
期刊
Therapie
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