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Usefulness of thiopurines therapeutic drug monitoring in patients with inflammatory bowel disease 硫嘌呤类治疗药物监测在炎症性肠病患者中的有效性。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-01 Epub Date: 2025-03-24 DOI: 10.1016/j.therap.2025.03.001
Zohra Chadli , Ibtissem Hannachi , Nadia Ben Fredj , Hichem Loghmari , Haifa Ben Romdhane , Ahlem Slama , Amel Chaabane , Leila Safer , Karim Aouam

Introduction

Thiopurine drugs, the most commonly prescribed immunosuppressive agents used in the treatment of inflammatory bowel disease (IBD), are characterized by a narrow therapeutic window, which makes therapeutic drug monitoring (TDM) of thiopurine metabolites recommended. 6-thioguanine nucleotides (6-TGN) are considered the most active metabolites of the thiopurines and they are responsible for therapeutic efficacy and correlate with myelotoxicity. This present study aims to assess the usefulness of 6-TGN monitoring in Tunisian patients with IBD.

Patients and methods

We performed a retrospective study including patients with IBD treated by azathioprine and underwent a TDM of 6-TGN between May 2018 and December 2023. Samples of venous blood were collected at 2 hours after medication intake. Concentrations values were determined, at the steady-state, using a technique of High-performance liquid chromatography (HPLC). Correlations between the 6-TGN concentrations and hematological parameters were assessed by Pearson's correlation coefficient.

Results

A total of 140 patients were included (65 men/75 women). The average concentration was 386.2 ± 258.9 pmol/8 × 108 RBCs. After an initial dose, only 49% of the patients had 6-TGN concentrations in the target range. The multiple TDM after AZA dose adjustment has shown improvement of the probability of obtaining 6-TGN concentration in the target range (69%). In our study, we demonstrated that 6-TGN concentrations were inversely correlated with hemoglobin levels, white cell, and neutrophil counts.

Conclusion

We have shown the usefulness of AZA TDM by determining the 6-TGN metabolite concentrations in Tunisian patients. However, this approach remains insufficient to optimize the treatment by azathioprine. Other approaches, such as genotyping patients for TPMT and NUD15 and adjusting AZA doses based on population pharmacokinetic models, appear to be essential for optimizing AZA therapy.
简介:硫嘌呤类药物是治疗炎症性肠病(IBD)最常用的免疫抑制剂,其特点是治疗窗口较窄,因此推荐对硫嘌呤代谢物进行治疗药物监测(TDM)。6-硫鸟嘌呤核苷酸(6-TGN)被认为是硫嘌呤最活跃的代谢物,它们负责治疗效果并与骨髓毒性相关。本研究旨在评估6-TGN监测在突尼斯IBD患者中的有用性。患者和方法:我们进行了一项回顾性研究,纳入了2018年5月至2023年12月期间接受硫唑嘌呤治疗且TDM为6-TGN的IBD患者。服药后2小时采集静脉血。在稳定状态下,使用高效液相色谱(HPLC)技术测定浓度值。采用Pearson相关系数评价6-TGN浓度与血液学参数的相关性。结果:共纳入140例患者(男65例,女75例)。平均浓度为386.2±258.9pmol/8×108。在初始剂量后,只有49%的患者的6-TGN浓度在目标范围内。调整AZA剂量后的多次TDM获得目标范围内6-TGN浓度的概率提高(69%)。在我们的研究中,我们证明了6-TGN浓度与血红蛋白水平、白细胞和中性粒细胞计数呈负相关。结论:我们通过测定突尼斯患者的6-TGN代谢物浓度,证明了AZA TDM的有效性。然而,这种方法尚不足以优化硫唑嘌呤的治疗效果。其他方法,如对患者进行TPMT和NUD15基因分型,以及根据群体药代动力学模型调整AZA剂量,似乎对优化AZA治疗至关重要。
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引用次数: 0
Drugs and patient's dissatisfaction reporting: From a disproportionality pharmacovigilance analysis to social pharmacology 药物与患者不满报告:从不均衡药物警戒分析到社会药理学。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-01 Epub Date: 2025-05-01 DOI: 10.1016/j.therap.2025.04.005
Jean-Louis Montastruc

Introduction

Patient satisfaction is a key element in medical practice. Few studies have investigated patient satisfaction or dissatisfaction with their drug treatment.

Method

Using the World Health Organization (WHO) global pharmacovigilance database, we investigated, through disproportionality analyses, potential associations between exposure to drugs and “patient dissatisfaction with treatment” reports. All reports of “patient dissatisfaction with treatment” in adults until 31/12/2024 were included.

Results/discussion

Results are expressed as reporting odds ratio (ROR). Among 506 reports, three quarters came from consumers, involving mainly women aged between 45 and 64. The main coreported term was drug inefficacy (before adverse drug reactions). The first anatomical therapeutic chemical (ATC) group was dermatological drugs (25.5%) followed by alimentary tract and metabolism (24.3%), nervous system (22.5%) drugs. A significant association was found with 22 drugs with the highest ROR values for plecanatide, efinaconazole and avatrombopag.

Conclusion

Despite its mandatory limitations (underreporting, selective reporting…), this study shows that pharmacovigilance data could help to understand some aspects of social pharmacology, here, patient dissatisfaction with their drug treatment.
患者满意度是医疗实践的关键因素。很少有研究调查患者对药物治疗的满意度或不满意度。方法:利用世界卫生组织(WHO)全球药物警戒数据库,通过歧化分析,调查药物暴露与“患者对治疗不满意”报告之间的潜在关联。截至2024年12月31日,所有成人“患者对治疗不满意”的报告均被纳入。结果/讨论:结果以报告优势比(ROR)表示。在506份报告中,四分之三来自消费者,主要涉及年龄在45至64岁之间的女性。共同报告的主要术语为药物无效(药物不良反应前)。解剖治疗化学(ATC)组以皮肤类药物为主(25.5%),其次为消化道及代谢类药物(24.3%)、神经系统类药物(22.5%)。发现与22种药物有显著相关性,其中普莱那肽、艾非那康唑和阿瓦龙帕格的ROR值最高。结论:尽管存在强制性限制(少报、选择性报告等),但本研究表明,药物警戒数据可以帮助了解社会药理学的某些方面,例如患者对药物治疗的不满。
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引用次数: 0
Patients under treatment for sarcoidosis reported adherence issues and would welcome personalized pharmaceutical care: Results from survey online 接受结节病治疗的患者报告了依从性问题,并欢迎个性化的药物护理:来自在线调查的结果。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-01 Epub Date: 2025-05-14 DOI: 10.1016/j.therap.2025.05.001
Cléa Dubrou , Dorian Protzenko , Aurélie S. Leroyer , Raphael Cauchois , Gilles Kaplanski , Guillaume Hache
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.
结节病是一种以显著的健康差异为特征的免疫炎性疾病。大约50%的结节病患者需要长期甚至终身治疗来阻止疾病的发展。最近的指南,主要针对肺结节病,已经提出。尽管如此,关于结节病药物依从性的报道很少,药物治疗很少纳入以患者为中心的治疗策略。在我们的研究中,我们通过社交媒体进行了一项调查(n=157),发现79%的参与者根据Girerd评分轻微或根本没有坚持他们的药物治疗方案。本项目的主要目的是查明影响结节病患者不依从性的因素。我们发现使用皮质类固醇或保留皮质类固醇的药物治疗,再加上年龄和肺定位等因素,与较差的依从性结果有关。此外,依从性差的患者表示愿意接受个性化的药物治疗。
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引用次数: 0
Clinical consequences of varenicline shortage: A study on the French national pharmacovigilance database 伐尼克兰短缺的临床后果:法国国家药物警戒数据库的研究。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-01 Epub Date: 2025-03-05 DOI: 10.1016/j.therap.2025.02.009
Amélie Lepert , Delphine Bourneau-Martin , Bénédicte Lebrun-Vignes , Alexandra Gentil , Pierre Brunel , Ivan Berlin , Marie Briet

Objectives

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.

Methods

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.

Results

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.

Discussion

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.
目的:伐尼克兰是一种被列入世界卫生组织(世卫组织)基本药物标准清单的戒烟疗法。2021年5月,在伐尼克兰片剂中检测到致癌物质n -亚硝基-伐尼克兰,其含量超过了欧洲药品管理局(EMA)确定的限量,导致批次被召回,并造成该药短缺。本研究的目的是利用药物警戒数据来评估伐尼克兰短缺的临床后果。方法:从法国药物警戒数据库中提取数据,使用以下术语:“varenicline(酒石酸盐)”、“varenicline”和“varenicline的酒石酸盐”作为2021年4月4日至2023年3月17日的疑似、相互作用或伴随用药。每个病例都由药物警戒专家审查,以选择仅涉及伐尼克兰短缺的病例。结果:32例纳入病例中,报告的不良反应为:吸烟复发(n=21),戒烟失败(n=7),烟草戒断综合征(n=2)。大多数患者表现出高度的烟草依赖。在使用伐尼克兰之前,这些吸烟者平均每天吸烟20支。他们在服用伐仑克林时没有吸烟。在短缺之后,所有接受尼古丁替代疗法(NRT)的患者每天的香烟消费量增加到10支,而不使用NRT的患者则增加到20支。讨论:在varenicline短缺的背景下,药物警戒数据证实了重度烟瘾患者吸烟复发和/或戒烟失败的风险。鉴于吸烟暴露在呼吸道、癌症和心血管风险中的作用,确保这种药物的可得性至关重要。解决办法,例如进口通过杂质定量检测的其他品牌生产的替代品,可以防止这种情况下的风险。
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引用次数: 0
Perceptions of contribution of the placebo effects to drug efficacy in community pharmacy practice: A cross-sectional survey 在社区药房实践中,安慰剂效应对药物疗效的贡献:一项横断面调查。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-01 Epub Date: 2025-03-18 DOI: 10.1016/j.therap.2025.02.015
Joey Fournier , Leo Druart , Marie Allier , Matthieu Roustit

Introduction

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.

Material and methods

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.

Results

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.

Conclusion

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.
前言:安慰剂效应是临床实践中一个有充分证据的现象,它仍然是复杂和多方面的。虽然各种医疗保健专业人员对安慰剂效应的看法进行了评估,但药剂师——治疗效果和有效性方面公认的专家——还没有被专门研究过。本横断面研究旨在评估在法国、瑞士和比利时的社区药房工作的卫生保健专业人员关于安慰剂效应的知识和看法。材料与方法:于2023年9 - 12月对药师、药学技术人员和社区药学专业学生进行问卷调查。问卷采用数字量表(0-10)来评估对安慰剂效应、潜在机制、影响因素和人口学细节的了解。结果:共收集了377份回复,主要来自法国执业的女药剂师。受访者对安慰剂效应有很强的理论理解(n=302;80%)。在12个影响安慰剂效应的环境因素中,评价最高的三个是与患者相关的:患者的期望和偏好,过去的经历,以及对自己病情的信念或陈述。对安慰剂效果的认知因药物类型的不同而有显著差异,证明有效的治疗方法的中位数得分为1[0-3],没有证明有效的常规药物的中位数得分为3[1-5],补充和替代药物(CAM)的中位数得分为6[4-9]。这表明,与安慰剂相关的疗效被认为与药物类型(例如,CAM与传统药物)更多地相关,而不是存在或不存在已证实的疗效。结论:药师对安慰剂效应有扎实的理论把握,但似乎安慰剂相关疗效与药物类型的关系比疗效证据的关系更强。这些发现强调需要提高以药物为基础的医疗保健专业人员对治疗效果的认识,以改善临床实践和患者护理。
{"title":"Perceptions of contribution of the placebo effects to drug efficacy in community pharmacy practice: A cross-sectional survey","authors":"Joey Fournier ,&nbsp;Leo Druart ,&nbsp;Marie Allier ,&nbsp;Matthieu Roustit","doi":"10.1016/j.therap.2025.02.015","DOIUrl":"10.1016/j.therap.2025.02.015","url":null,"abstract":"<div><h3>Introduction</h3><div>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.</div></div><div><h3>Material and methods</h3><div>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.</div></div><div><h3>Results</h3><div>A total of 377 responses were collected, primarily from female pharmacists practicing in France. Respondents demonstrated a strong theoretical understanding of placebo effects (<em>n</em> <!-->=<!--> <!-->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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"80 6","pages":"Pages 689-695"},"PeriodicalIF":1.8,"publicationDate":"2025-11-01","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}
引用次数: 0
Corrigendum to “Thrombotic events after AstraZeneca vaccine: What if it was related to dysfunctional immune response?” Therapie 2021;76:367-9. “阿斯利康疫苗后的血栓事件:如果它与功能失调的免疫反应有关怎么办?”Therapie 2021; 76:367-9。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-01 Epub Date: 2025-10-22 DOI: 10.1016/j.therap.2025.09.005
Eric Billy , Franck Clarot , Corinne Depagne , Stéphane Korsia-Meffre , Michaël Rochoy , Florian Zores
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引用次数: 0
[REB methodology application on topical and oral NSAIDS' therapeutic benefit evaluation on acute pain related to musculoskeletal injuries]. [REB方法学在局部和口服非甾体抗炎药治疗肌肉骨骼损伤相关急性疼痛疗效评价中的应用]。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-30 DOI: 10.1016/j.therap.2025.10.005
François Lacour, Nicolas Criscito, Rémy Boussageon

Introduction: Acute musculoskeletal injuries are a common reason for primary care consultations. Nonsteroidal anti-inflammatory drugs (NSAIDs) are currently used in this context. Recent meta-analyses (M-A) showed a better benefit--risk profile for topical NSAIDs and no superiority of oral NSAIDs over paracetamol alone or in combination in terms of pain relief. It seems appropriate to evaluate rigorously NSAIDs' benefit-risk balance to support more consistent recommendations and promote appropriate evidence-based use of this drug class in trauma care.

Objective: This study's objective is to assess the efficacy and benefit-risk balance of oral and topical NSAIDs in the management of acute pain related to acute musculoskeletal injuries.

Materials and methods: A systematic review was conducted using public databases Medline (PubMed), CENTRAL (Cochrane) and Embase. Controlled randomised trials (RCTs) evaluating oral and topical NSAIDs (diclofenac, ibuprofen, ketoprofen and naproxen) for the treatment of acute pain from minor soft tissue injuries were included. These RCTs are from 2020 meta-analysis by Busse et al. bibliographic references and from complementary research from January 2020 to December 2023. Primary outcome is short-term pain (from 30minutes to 7days). Secondary outcomes are pain at rest, pain on movement (preferably on day 3), and safety analysis for oral and topical forms. Risk of bias was assessed using the Risk of Bias version 2 (RoB2) tool. Meta-analyses were done with Review Manager (RevMan) software. Levels of evidence were evaluated using both the REB and GRADE methods.

Results: The REB analysis concluded to a "solid evidence" for topical diclofenac (based on 10 RCTs and 7 confirmatory studies), to an "evidence requiring confirmation" evidence for topical ibuprofen (2 RCTs) and topical ketoprofen (2 RCTs). REB evaluation also concluded to a lack of proof for naproxen and for oral NSAIDs. GRADE analysis showed a low quality of evidence for topical NSAIDs efficacy and a high quality of evidence for their safety. It showed a very low quality of evidence for oral NSAIDs efficacy and safety.

Conclusion: According to REB methodology, topical NSAIDs, unlike oral formulations, have demonstrated efficacy in managing acute pain related to musculoskeletal injuries. These results reinforce recent meta-analyses favoring topical NSAIDs and recommending to limit the use of oral NSAIDs due to a lack of proof in this indication. Finally, NSAIDs impact on tissue healing has not been objectively studied by RCTs in humans, so further research is warranted. The use of NSAIDs in trauma care may potentially evolve as new data and knowledge emerge.

急性肌肉骨骼损伤是初级保健咨询的常见原因。非甾体抗炎药(NSAIDs)目前在这种情况下使用。最近的荟萃分析(M-A)显示,局部使用非甾体抗炎药有更好的益处-风险状况,在缓解疼痛方面,口服非甾体抗炎药没有单独或联合使用扑热息痛的优势。严格评估非甾体抗炎药的获益-风险平衡似乎是合适的,以支持更一致的建议,并促进在创伤护理中适当使用这类药物。目的:本研究的目的是评估口服和外用非甾体抗炎药治疗急性肌肉骨骼损伤相关急性疼痛的疗效和收益-风险平衡。材料和方法:使用公共数据库Medline (PubMed)、CENTRAL (Cochrane)和Embase进行系统评价。纳入了评估口服和外用非甾体抗炎药(双氯芬酸、布洛芬、酮洛芬和萘普生)治疗轻微软组织损伤急性疼痛的对照随机试验(RCTs)。这些随机对照试验来自Busse等人的2020年元分析文献参考文献和2020年1月至2023年12月的补充研究。主要结局是短期疼痛(从30分钟到7天)。次要结果是静息时疼痛,运动时疼痛(最好在第3天),以及口服和局部剂型的安全性分析。使用风险偏倚版本2 (RoB2)工具评估偏倚风险。meta分析采用Review Manager (RevMan)软件进行。采用REB和GRADE两种方法评估证据水平。结果:REB分析得出双氯芬酸外用的“确凿证据”(基于10项随机对照试验和7项验证性研究),布洛芬外用(2项随机对照试验)和酮洛芬外用(2项随机对照试验)为“需要证实的证据”。REB评估也得出结论,萘普生和口服非甾体抗炎药缺乏证据。GRADE分析显示,局部使用非甾体抗炎药有效的证据质量较低,而安全性的证据质量较高。这表明口服非甾体抗炎药的有效性和安全性的证据质量很低。结论:根据REB方法,局部非甾体抗炎药,不像口服配方,已证明有效管理急性疼痛相关的肌肉骨骼损伤。这些结果加强了最近的荟萃分析,支持局部使用非甾体抗炎药,并建议限制口服非甾体抗炎药的使用,因为缺乏这种适应症的证据。最后,非甾体抗炎药对人体组织愈合的影响尚未通过随机对照试验客观研究,因此需要进一步研究。随着新数据和新知识的出现,非甾体抗炎药在创伤护理中的应用可能会不断发展。
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引用次数: 0
[Assessing the quality of evidence cited in French clinical practice guidelines for infectious diseases in primary care]. [评估法国初级保健传染病临床实践指南中引用的证据质量]。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-20 DOI: 10.1016/j.therap.2025.10.004
Eulalie Gillet-Lecourt, Kenza Akhamlich, Mikaël Bouchard, Mathilde François, Irène Supper, Rémy Boussageon

Objective: To assess the level of evidence supporting antibiotic therapy recommendations in primary care.

Method: After collecting the clinical practice guidelines (CPGs) listed on the Antibioclic® website (https://antibioclic.com), each recommendation regarding whether or not to prescribe antibiotics was evaluated based on whether it included a GRADE classification by the French National Authority for Health (HAS): A, B, C, or Expert Opinion (EO). The sources cited by the CPGs were reviewed. The recommendations and studies had to answer the question: "Should antibiotic therapy be prescribed in this situation?" The possible answers were "yes," "no," or "conditional yes," meaning delayed prescription. The primary outcome was the percentage of recommendations for which supporting studies were cited, in comparison to the stated GRADE.

Results: A total of 152 recommendations from 49 CPGs on antibiotic prescription were analyzed. In all, 71.7% did not mention a level of evidence, 3.3% were classified as GRADE A, and 9.2% as GRADE B. Upon reviewing the studies used to justify the recommendations, high-quality evidence was identified for only 7.9% of the recommendations, while 80.9% had no referenced studies.

Conclusion: Most French recommendations regarding antibiotic prescription in primary care do not provide the level of evidence supporting them.

目的:评估在初级保健中推荐抗生素治疗的证据水平。方法:收集Antibioclic®网站(https://antibioclic.com)上列出的临床实践指南(cpg)后,根据是否包含法国国家卫生管理局(HAS)的GRADE分类:a、B、C或专家意见(EO),对每项关于是否开具抗生素的建议进行评估。审查了CPGs引用的来源。这些建议和研究必须回答这样一个问题:“在这种情况下应该开抗生素治疗吗?”可能的答案是“是”、“否”或“有条件的是”,意思是延迟处方。主要结果是与所述GRADE相比,被引用的支持性研究的建议百分比。结果:分析了49家CPGs对抗生素处方的152条建议。总的来说,71.7%没有提到证据水平,3.3%被归类为a级,9.2%被归类为b级。在回顾用于证明建议的研究时,只有7.9%的建议被确定为高质量证据,而80.9%没有参考研究。结论:法国关于初级保健中抗生素处方的大多数建议没有提供支持它们的证据水平。
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引用次数: 0
Artificial intelligence for precision medicine. 精准医疗的人工智能。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-08 DOI: 10.1016/j.therap.2025.10.003
Marie-Elise Martel, Adan José-Garcia, Celine Vens, Maarten De Vos, Vincent Sobanski

Introduction: Precision medicine aims to tailor healthcare decisions and interventions to the unique biological and clinical characteristics of each patient. The recent convergence of artificial intelligence (AI) with advances in digital health, omics, and big data analytics has accelerated progress toward this goal. AI technologies - particularly machine learning, deep learning, natural language processing and generative large language models - enable the rapid and meaningful analysis of complex biomedical datasets, supporting more individualized care.

Purpose of review: In this narrative review, we provide an accessible overview of the core principles of AI for healthcare professionals and explore its practical applications across the spectrum of precision medicine. Real-world examples highlight how AI is being used to enhance early diagnosis, guide treatment selection, support disease prevention, and even contribute directly to therapeutic interventions. Alongside these advances, we discuss critical limitations and challenges, including ethical considerations, algorithmic bias, data privacy concerns, environmental impact, and practical barriers to clinical implementation.

Conclusion: This review offers both an introduction to AI and a practical overview of how it is being used, and where its limitations lie, in precision medicine, with the goal of helping healthcare professionals understand these evolving tools and use them efficiently and responsibly in clinical practice.

导读:精准医学旨在根据每位患者独特的生物学和临床特征量身定制医疗保健决策和干预措施。最近,人工智能(AI)与数字健康、组学和大数据分析的进步相结合,加速了实现这一目标的进程。人工智能技术,特别是机器学习、深度学习、自然语言处理和生成式大型语言模型,能够对复杂的生物医学数据集进行快速和有意义的分析,从而支持更加个性化的护理。综述目的:在这篇叙述性综述中,我们为医疗保健专业人员提供了人工智能核心原则的可访问概述,并探索其在整个精准医学领域的实际应用。现实世界的例子突出了人工智能如何用于加强早期诊断,指导治疗选择,支持疾病预防,甚至直接促进治疗干预。除了这些进步,我们还讨论了关键的限制和挑战,包括伦理考虑、算法偏见、数据隐私问题、环境影响和临床实施的实际障碍。结论:本综述既介绍了人工智能,也概述了人工智能在精准医学中的应用情况及其局限性,目的是帮助医疗保健专业人员了解这些不断发展的工具,并在临床实践中高效、负责任地使用它们。
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引用次数: 0
Digital pharmacological twins: Bridging multi-scale modelling and artificial intelligence for precision medicine: The DIGPHAT consortium. 数字药理学双胞胎:连接多尺度建模和精确医学的人工智能:DIGPHAT联盟。
IF 1.8 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-09-26 DOI: 10.1016/j.therap.2025.09.006
Jean-Baptiste Woillard, Sébastien Benzekry, Julie Josse, Mélanie White-Koning, Etienne Chatelut, Emmanuelle Comets, Florian Lemaitre, Bénédicte Franck, Matthieu Gregoire, Françoise Stanke-Labesque, Sarah Zohar, Moreno Ursino, Christophe Battail

The advent of digital twins in pharmacology presents transformative potential for precision medicine, enabling personalized treatment optimization through dynamic computational simulations of drug interactions at molecular, cellular, and patient levels. These advanced virtual replicas of a patient's biological system are designed to predict individual therapeutic responses with high fidelity, thereby moving beyond the one-size-fits-all paradigm. This paper explores the concept of digital pharmacological twins, detailing how they can integrate heterogeneous data, including multi-omic, pharmacokinetic, pharmacodynamic, clinical, and environmental information, and employing a synergy of advanced mechanistic and machine learning models. Using illustrative examples from ongoing international initiatives, this work highlights the methodological frameworks necessary for developing and validating such comprehensive predictive tools. We underscore the critical importance of model interoperability, robust data integration strategies, and rigorous validation to ensure clinical utility. Ultimately, digital pharmacological twins promise to enhance therapeutic efficacy, minimize adverse drug reactions, and accelerate the translation of pharmacological science into tangible patient benefits.

数字双胞胎在药理学领域的出现为精准医疗提供了变革潜力,通过在分子、细胞和患者水平上对药物相互作用进行动态计算模拟,实现个性化治疗优化。这些先进的患者生物系统的虚拟复制品旨在以高保真度预测个体治疗反应,从而超越了一刀切的模式。本文探讨了数字药理学双胞胎的概念,详细介绍了它们如何整合异构数据,包括多组学、药代动力学、药效学、临床和环境信息,并采用先进的机制和机器学习模型的协同作用。通过使用正在进行的国际倡议的说明性例子,这项工作强调了开发和验证这种综合预测工具所必需的方法框架。我们强调了模型互操作性、稳健的数据集成策略和严格验证的重要性,以确保临床应用。最终,数字药理学双胞胎有望提高治疗效果,最大限度地减少药物不良反应,并加速将药理学科学转化为切实的患者利益。
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