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Career commitment and professional satisfaction among Romanian pharmacy graduates: a nationwide cross-sectional survey. 罗马尼亚药学毕业生的职业承诺和专业满意度:一项全国性的横断面调查。
IF 4.3 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-03-05 eCollection Date: 2026-01-01 DOI: 10.3389/jpps.2026.15679
Marius Călin Cherecheş, Aura Rusu

Introduction: Professional satisfaction is a key determinant of career commitment and workforce sustainability and retention in the pharmacy sector. The study examines professional satisfaction among Romanian pharmacy graduates by analysing hygiene factors, intrinsic motivators, and perceptions of pay equity, assessing sector-based differences and exploring associations between these dimensions and long-term career commitment.

Methods: A cross-sectional survey was conducted among 473 pharmacy graduates (2009-2023). Professional satisfaction was evaluated using 13 structured items from a questionnaire that covered hygiene factors, intrinsic motivators, and perceptions of pay equity. Reliability was assessed with Cronbach's α. Descriptive statistics, ANOVA, and chi-square tests were applied.

Results: The Hygiene Index (α = 0.67; M = 3.28, SD = 0.76) and Motivators Index (α = 0.80; M = 3.22, SD = 0.86) reflected moderate satisfaction. The Pay-Equity Index showed very low scores (α = 0.77; M = 1.86, SD = 0.70). Salary satisfaction (M = 2.22, SD = 1.23) and expectations for future salary increases (M = 2.21, SD = 1.06) were rated as the lowest. Over 80% perceived their income as "much lower" than that of physicians or dentists. Only 7% stated they would "definitely" choose pharmacy again, while 46% responded "definitely not," and over 70% expressed some degree of non-recommitment. Community pharmacists consistently reported lower satisfaction across indices compared to peers in industry or education.

Conclusion: Romanian pharmacists report moderate satisfaction with work conditions and collegiality, but widespread dissatisfaction with pay equity and career opportunities. Alarmingly, almost three-quarters of pharmacists said they would not choose pharmacy again, indicating a lack of professional commitment. The results raise substantial concerns about professional commitment and suggest a risk to the long-term sustainability of the Romanian pharmacy workforce. Urgent policy interventions are needed to address salary disparities, improve recognition, and expand career development pathways to retain qualified professionals and ensure the resilience of pharmaceutical services.

简介:职业满意度是职业承诺、劳动力可持续性和保留的关键决定因素。该研究通过分析卫生因素、内在激励因素和对薪酬公平的看法,评估行业差异,并探讨这些因素与长期职业承诺之间的关系,来调查罗马尼亚药学毕业生的职业满意度。方法:对2009-2023年药学专业毕业生473人进行横断面调查。职业满意度是用问卷中的13个结构化项目来评估的,这些项目包括卫生因素、内在激励因素和对薪酬公平的看法。采用Cronbach’s α评价信度。采用描述性统计、方差分析和卡方检验。结果:卫生指标(α = 0.67, M = 3.28, SD = 0.76)和激励指标(α = 0.80, M = 3.22, SD = 0.86)为中等满意度。薪酬公平指数得分极低(α = 0.77, M = 1.86, SD = 0.70)。薪酬满意度(M = 2.22, SD = 1.23)和对未来加薪的预期(M = 2.21, SD = 1.06)被评为最低。超过80%的人认为他们的收入比医生或牙医“低得多”。只有7%的人表示他们“肯定”会再次选择药店,而46%的人回答“绝对不会”,超过70%的人表示一定程度上不会再选择药店。社区药剂师一致报告满意度较低的指数相比,同行在工业或教育。结论:罗马尼亚药剂师对工作条件和同事关系的满意度中等,但对薪酬公平和职业机会的普遍不满。令人担忧的是,近四分之三的药剂师表示他们不会再选择药学,这表明他们缺乏职业承诺。结果引起了对专业承诺的实质性关注,并建议对罗马尼亚药房劳动力的长期可持续性存在风险。需要采取紧急政策干预措施,解决薪酬差距问题,提高认可度,扩大职业发展途径,以留住合格的专业人员,并确保制药服务的复原力。
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引用次数: 0
Rethinking asthma therapy, part 1: transdermal delivery of β2-agonists. 反思哮喘治疗,第一部分:β2激动剂的经皮递送。
IF 4.3 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-03-04 eCollection Date: 2026-01-01 DOI: 10.3389/jpps.2026.15713
Joseph Correa, Nicole K Brogden

Asthma and allergies are closely related conditions affecting millions of people around the world. Current treatment options cover many classes of drugs for both acute and ongoing conditions. β2-agonists, leukotriene modifiers, and corticosteroids represent some of the common types of drugs utilized in asthma management. These medications are often delivered via inhalation, oral, or parenteral methods, but each of these modalities faces challenges due to improper technique with inhalers, lessened oral bioavailability due to first-pass metabolism, and reduced compliance of injectable medicines. Transdermal drug delivery may offer a beneficial route of administration that overcomes these barriers as a painless, self-administered form that bypasses first-pass metabolism and can reduce dosing frequency with longer drug release profiles and reduced fluctuations in plasma drug levels. In this two-part mini-review series we will summarize the current literature on transdermal systems for asthma and allergy therapy. Here in Part 1, we cover β2-agonists and discuss the potential of transdermal systems for these drugs. While the body of work with transdermal β2-agonists for asthma treatment is limited, there is still evidence that transdermal systems for asthma has potential to greatly shift the field of asthma therapeutics.

哮喘和过敏是密切相关的疾病,影响着全世界数百万人。目前的治疗方案涵盖了许多类别的药物,用于急性和持续性疾病。β2激动剂、白三烯调节剂和皮质类固醇是哮喘治疗中常用的几种药物。这些药物通常通过吸入、口服或肠外方法给药,但由于吸入器技术不当,由于首次代谢导致口服生物利用度降低,以及注射药物的依从性降低,每种方式都面临挑战。经皮给药可能是一种有益的给药途径,可以克服这些障碍,作为一种无痛、自我给药的形式,绕过第一次代谢,可以减少给药频率,延长药物释放谱,减少血浆药物水平的波动。在这个由两部分组成的迷你回顾系列中,我们将总结目前关于透皮系统治疗哮喘和过敏的文献。在第1部分中,我们将介绍β2激动剂,并讨论这些药物在透皮系统中的潜力。虽然经皮β2激动剂治疗哮喘的研究有限,但仍有证据表明,经皮系统治疗哮喘有可能极大地改变哮喘治疗领域。
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引用次数: 0
Rethinking asthma therapy, part 2: transdermal strategies for adjunct asthma and allergy treatments. 反思哮喘治疗,第2部分:辅助哮喘和过敏治疗的透皮策略。
IF 4.3 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-03-04 eCollection Date: 2026-01-01 DOI: 10.3389/jpps.2026.15714
Joseph Correa, Nicole K Brogden

Asthma and allergies affect millions of people globally. Avoiding triggers and allergens is a basic management technique for all asthma subtypes (>80% of asthma patients also suffer from allergies), and pharmacological treatment is the cornerstone for acute exacerbations and ongoing maintenance. Typical treatment options for asthma include inhaled, oral, or injectable dosage forms. However, transdermal drug delivery has great potential to provide an alternative route of administration of necessary asthma and allergy therapies that have traditionally been given in other dosage forms. In Part 1 of this two-part series, we discussed the work done towards incorporating short- and long-acting β2-agonists into transdermal drug delivery systems. Here in part 2, we describe the current literature for transdermal applications of leukotriene antagonists, theophylline, and other adjunct medications that do not fall into one specific drug class. A brief overview of biologics, particularly monoclonal antibodies, and the role in asthma is also included, including some context of transdermal mAb delivery for disease states beyond asthma. Because of the relatedness of asthma and allergies, transdermal applications for allergen immunotherapy is also discussed.

哮喘和过敏影响着全球数百万人。避免诱因和过敏原是所有哮喘亚型的基本管理技术(bbbb80 %的哮喘患者也患有过敏症),药物治疗是急性加重和持续维持的基础。哮喘的典型治疗方案包括吸入、口服或注射剂型。然而,经皮给药具有很大的潜力,为传统上以其他剂型给予必要的哮喘和过敏治疗提供了另一种给药途径。在这个由两部分组成的系列文章的第1部分中,我们讨论了将短效和长效β2激动剂纳入透皮给药系统的工作。在第2部分中,我们描述了目前关于白三烯拮抗剂、茶碱和其他不属于特定药物类别的辅助药物的经皮应用的文献。简要概述了生物制剂,特别是单克隆抗体,以及在哮喘中的作用,包括一些针对哮喘以外疾病状态的经皮单抗递送的背景。由于哮喘和过敏的相关性,过敏原免疫治疗的透皮应用也被讨论。
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引用次数: 0
Editorial: Volume 2: real world evidence (RWE): paths to enhancing patient access to new medications. 编辑:第2卷:真实世界证据(RWE):促进患者获得新药的途径。
IF 4.3 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-03-04 eCollection Date: 2026-01-01 DOI: 10.3389/jpps.2026.16236
Allison Wills, Catherine Y Lau
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引用次数: 0
Corrigendum: Optimized Ginkgo biloba extract EGb 761®: boosted therapeutic benefits with minimized CYP enzyme interference. 勘误:优化银杏叶提取物EGb 761®:提高治疗效益与最小化CYP酶干扰。
IF 4.3 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-02-17 eCollection Date: 2026-01-01 DOI: 10.3389/jpps.2026.15563
Sunbeom Kwon, Suji Jeong, Seulah Lee

[This corrects the article DOI: 10.3389/jpps.2025.14614.].

[这更正了文章DOI: 10.3389/jpps.2025.14614.]。
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引用次数: 0
The effect of cryoprotectant and storage conditions on the aggregation of poly(ethylene glycol)-poly(α-benzyl carboxylate-ε-caprolactone) nanoparticles. 研究了低温保护剂和贮存条件对聚乙二醇-聚α-羧酸苄酯-ε-己内酯纳米粒子聚集的影响。
IF 4.3 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-02-13 eCollection Date: 2026-01-01 DOI: 10.3389/jpps.2026.15721
Nasim Sarrami, Soheyla Honary, Mohammad Reza Vakili, Afsaneh Lavasanifar

Introduction: The preparation of nanoparticles (NPs) in aqueous media leads to thermodynamic instability and aggregation during storage. The objective of this study was to identify an optimum condition for the storage of poly(ethylene glycol)-poly(α-benzyl carboxylate-ε-caprolactone) (PEG-PBCL) NPs with minimum to no NP aggregation.

Methods: Nanoparticles were prepared from PEG-PBCL of varied PBCL degrees of polymerization. Prepared NPs were either subjected to freeze-thaw or lyophilization with the addition of sugars or polyethylene glycols (PEGs) of varying molecular weight. The average diameter and polydispersity of NPs before and after freeze-thaw or lyophilization/reconstitution in water was assessed by dynamic light scattering and transmission electron microscopy (TEM). Differential Scanning Calorimetry (DSC) was used to compare the thermal behaviour of NPs before and after selected storage conditions.

Results: Irrespective of the DP of PBCL, minimum size growth in the freeze-drying method was achieved when PEG3350 and methoxy-PEG 5000 were used as cryoprotectant at a w/w ratio of 4:1 to PEG-PBCL. Under this condition, NP size increased about 2-fold after reconstitution. In the freeze-thaw method, both sucrose and PEGs of different molecular weights, protected the PEG-PBCL NPs of different PBCL length from significant size growth where average particle size growth was not more than 1.20 folds.

Conclusion: Our findings suggest that freeze-thawing of PEG-PBCL NP using sucrose or PEG can prevent the NP aggregation and is the best method for PEG-PBCL NP storage.

纳米粒子(NPs)在水介质中的制备导致了热力学不稳定性和储存过程中的聚集。本研究的目的是确定聚(乙二醇)-聚(α-苄基羧酸酯-ε-己内酯)(PEG-PBCL) NP的最佳储存条件,以达到最小或无NP聚集的目的。方法:采用不同聚合度的聚乙二醇-聚氯PBCL制备纳米颗粒。制备的NPs在加入不同分子量的糖或聚乙二醇(peg)的情况下进行冻融或冻干。通过动态光散射和透射电子显微镜(TEM)观察NPs在冻融或冻干/重构前后的平均直径和多分散性。采用差示扫描量热法(DSC)比较了NPs在选定的储存条件前后的热行为。结果:无论PBCL的DP如何,当PEG3350和甲氧基- peg 5000与PEG-PBCL以4:1的w/w比作为冷冻保护剂时,冷冻干燥法的尺寸增长最小。在此条件下,重构后的NP大小增加了约2倍。在冻融法中,蔗糖和不同分子量的peg都能保护不同PBCL长度的PEG-PBCL NPs不出现明显的粒径增长,平均粒径增长不超过1.20倍。结论:用蔗糖或聚乙二醇冷冻解冻PEG- pbcl NP可防止NP聚集,是保存PEG- pbcl NP的最佳方法。
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引用次数: 0
Targeted therapy and biomarker-guided applications of ecofriendly silver nanoparticles in precision oncology. 生态友好银纳米颗粒在精准肿瘤学中的靶向治疗和生物标志物引导应用。
IF 4.3 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-13 eCollection Date: 2025-01-01 DOI: 10.3389/jpps.2025.15403
Haider Hamzah

Eco-friendly silver nanoparticles (eco-AgNPs) represent a promising convergence of green nanotechnology and precision medicine for cancer treatment. This minireview examines the therapeutic potential of silver nanoparticles (AgNPs) synthesized through eco-friendly methods using plant extracts and microorganisms. These eco-friendly AgNPs demonstrate enhanced biocompatibility and selective cytotoxicity against malignant cells. These nanoparticles target cancer through multiple mechanisms including reactive oxygen species generation, apoptosis induction, and cell cycle disruption. Selectivity is achieved through surface functionalization with targeting moieties such as antibodies and aptamers that recognize overexpressed tumor receptors. The integration of biomarker-guided design enables tumor-specific delivery by exploiting unique metabolic signatures and cellular markers characteristic of different cancer types. Furthermore, AgNP-based theranostic platforms offer simultaneous diagnostic imaging and therapeutic intervention, providing real-time assessment of treatment response and enabling personalized dosing strategies. However, clinical translation faces significant challenges including potential long-term toxicity, standardization of synthesis protocols, and regulatory approval pathways. Successful clinical implementation will require interdisciplinary collaboration to optimize nanoparticle design, establish safety profiles, and develop combination therapies that maximize therapeutic benefits while minimizing side effects. Eco-AgNPs thus offer a transformative approach to cancer treatment that combines environmental sustainability with precision targeting capabilities.

生态友好型纳米银(eco-AgNPs)代表了绿色纳米技术和精准医学在癌症治疗方面的一个有希望的融合。本文综述了利用植物提取物和微生物通过生态友好的方法合成的银纳米颗粒(AgNPs)的治疗潜力。这些生态友好型AgNPs表现出增强的生物相容性和对恶性细胞的选择性细胞毒性。这些纳米颗粒通过多种机制靶向癌症,包括活性氧的产生、细胞凋亡的诱导和细胞周期的破坏。选择性是通过靶向部分的表面功能化实现的,如识别过表达的肿瘤受体的抗体和适体。生物标志物引导设计的整合通过利用独特的代谢特征和不同癌症类型的细胞标记来实现肿瘤特异性递送。此外,基于agnp的治疗平台提供同步诊断成像和治疗干预,提供治疗反应的实时评估,并实现个性化的给药策略。然而,临床翻译面临着巨大的挑战,包括潜在的长期毒性、合成方案的标准化和监管审批途径。成功的临床应用需要跨学科的合作,以优化纳米颗粒的设计,建立安全性,并开发联合疗法,最大限度地提高治疗效益,同时最大限度地减少副作用。因此,Eco-AgNPs为癌症治疗提供了一种变革性的方法,将环境可持续性与精确靶向能力相结合。
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引用次数: 0
Real-world safety profile of roflumilast: a pharmacovigilance analysis using FDA adverse event reporting system and Canada vigilance database. 罗氟司特的真实安全概况:使用FDA不良事件报告系统和加拿大警戒数据库进行药物警戒分析。
IF 4.3 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-12 eCollection Date: 2025-01-01 DOI: 10.3389/jpps.2025.15678
Rui Xu, Hui Peng, Chang Shu, Maochang Liu, Ping Gao

Background: Roflumilast, a highly selective phosphodiesterase 4 inhibitor, is used to treat with chronic obstructive pulmonary disease and psoriasis. We aim to determine potential roflumilast-associated adverse events (AEs) and the differences in AE signals among diverse populations.

Methods: Roflumilast's AE reports between the first quarter of 2011 and the fourth quarter of 2024 were obtained from the FDA Adverse Event Reporting System (FAERS) and Canada Vigilance Adverse Reaction Database (CVARD). The signal strength was measured by four disproportionality analysis methods, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).

Results: In FAERS, population aged ≥65 years and oral medication users accounted for a predominant proportion in the reported cases. FDA-unlabeled respiratory, thoracic and mediastinal disorders was the only one signal categorized by system organ class met all four algorithms. Newly identified AEs such as dyspnea, condition aggravated, cough, and tachycardia could contribute valuable safety considerations for clinical practice. The analysis of the available time-to-onset data suggested that cases often occurred within the first 30 days post-treatment. These results were externally validated in CVARD, suggesting consistent findings. Notably, headache was more frequently reported among users of topical formulations and female patients, while suicidal ideation and weight loss were more commonly reported in male patients and oral medications, respectively.

Conclusion: This study confirmed established adverse reactions and identified novel AEs in real-world clinical practice by dual-database pharmacovigilance analysis. Clinicians should remain vigilant for AEs that differ by gender and route to enable early intervention and improve prognosis. The findings highlight personalized safety management, while underscoring the necessity of prospective studies to validate results and further characterize roflumilast's safety profile.

背景:罗氟司特是一种高选择性磷酸二酯酶4抑制剂,用于治疗慢性阻塞性肺疾病和牛皮癣。我们的目的是确定潜在的罗氟司特相关不良事件(AE)和AE信号在不同人群中的差异。方法:从FDA不良事件报告系统(FAERS)和加拿大警戒不良反应数据库(CVARD)中获取2011年第一季度至2024年第四季度罗氟司特的不良反应报告。采用报告优势比(ROR)、比例报告比(PRR)、贝叶斯置信传播神经网络(BCPNN)和多项目伽玛泊松收缩器(MGPS)四种歧化分析方法测量信号强度。结果:在FAERS报告病例中,年龄≥65岁的人群和口服药物使用者占主要比例。fda未标记的呼吸、胸部和纵隔疾病是唯一一个按系统器官类别分类的信号满足所有四种算法。新发现的不良事件,如呼吸困难、病情加重、咳嗽和心动过速,可以为临床实践提供有价值的安全考虑。对现有发病时间数据的分析表明,病例通常发生在治疗后的前30天内。这些结果在CVARD中得到了外部验证,表明结果一致。值得注意的是,头痛在外用制剂使用者和女性患者中更为常见,而自杀意念和体重减轻分别在男性患者和口服药物中更为常见。结论:本研究通过双数据库药物警戒分析,确认了现实世界临床实践中已知的不良反应,并发现了新的ae。临床医生应对不同性别和途径的不良反应保持警惕,以便早期干预和改善预后。研究结果强调了个性化的安全管理,同时强调了前瞻性研究的必要性,以验证结果并进一步表征罗氟司特的安全性。
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引用次数: 0
Enhancement of oral bioavailability of risedronate through xyloglucan rafts. 通过木聚糖筏提高利塞膦酸盐的口服生物利用度。
IF 4.3 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-07 eCollection Date: 2025-01-01 DOI: 10.3389/jpps.2025.15525
Nader I Namazi, Rawan Bafail, Abdulkareem Ali Alanezi, Afaf F Almuqati, Mohammed Salem Alshammari, Majed A Alghamdi

Bisphosphonates irritate the stomach and oesophagus and have a very limited absorption. The purpose of this study was to increase risedronate (RDN) oral bioavailability by causing a raft to form in the stomach. The creation of a raft prevents the irritation of the stomach and oesophagus caused by bisphosphonates. FTIR, TGA, and DSC were used to characterise the RDN, XLG, and the created formulation. In addition to a cell viability analysis utilising Caco-2 cells, the release of RDN was investigated in 0.1 N HCl, 0.5 N HCl, 1 N HCl, and simulated gastric fluid (SGF). For the pharmacokinetic investigation, the XR5 formulation and the Actonel® tablet were chosen as the test and reference formulations, respectively. Using a parallel design, twelve healthy albino rats were split into two groups, and blood samples were gathered for a whole day. RDN was distributed uniformly throughout the raft and demonstrated chemical stability by the FTIR. The formulation's thermal stability was demonstrated by the TGA and DSC. At 20 min, the SGF showed a 99.97% RDN release. When compared to the RDN suspension, the pharmacokinetics revealed better RDN values from the XLG raft. The RDN from the recently developed XR5 has a better bioavailability than the Actonel® tablet.

双膦酸盐刺激胃和食道,吸收非常有限。本研究的目的是通过在胃中形成一个筏子来增加利塞膦酸盐(RDN)的口服生物利用度。筏子的形成可以防止双膦酸盐对胃和食道的刺激。FTIR, TGA和DSC用于表征RDN, XLG和所创建的配方。除了利用Caco-2细胞进行细胞活力分析外,还研究了RDN在0.1 N HCl、0.5 N HCl、1 N HCl和模拟胃液(SGF)中的释放情况。以XR5制剂和Actonel®片为试验制剂和参比制剂进行药代动力学研究。采用平行设计,将12只健康的白化病大鼠分为两组,采集了一整天的血液样本。RDN在筏体中分布均匀,FTIR显示其化学稳定性。通过热重分析(TGA)和差热分析(DSC)验证了该配方的热稳定性。在20分钟,SGF显示99.97%的RDN释放。与RDN悬液相比,药代动力学显示XLG筏的RDN值更好。最近开发的XR5的RDN具有比Actonel®片剂更好的生物利用度。
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引用次数: 0
Refined pharmacovigilance assessment of immune checkpoint inhibitors-related bullous pemphigoid: a multi-methodological approach utilizing FAERS database. 免疫检查点抑制剂相关大疱性类天疱疮的精细药物警戒评估:利用FAERS数据库的多方法方法。
IF 4.3 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-07 eCollection Date: 2025-01-01 DOI: 10.3389/jpps.2025.15597
Yan Wang, Liu-Yi-Yi Yang, Ya-Gang Zuo

Objectives: To evaluate the potential risk of bullous pemphigoid (BP) in patients treated with immune checkpoint inhibitors (ICIs) and to characterize ICI-related BP (irBP) using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods: The present study conducted a disproportionality analysis leveraging FAERS database, spanning the first quarter (Q1) of 2004-2025 Q1. To ensure robust signal detection, we employed a quadruple analytical approach incorporating: (1) reporting odds ratio (ROR), (2) proportional reporting ratio, (3) Bayesian confidence propagation neural network, and (4) multi-item gamma Poisson shrinker algorithms. These methodologies were systematically applied to assess the potential risk of BP in patients treated with ICIs. Furthermore, temporal characteristics of adverse event emergence were quantitatively assessed to delineate the time-to-onset patterns.

Results: There are 850 irBP cases identified, comprising reports associated with the following agents: nivolumab (n = 530), pembrolizumab (n = 180), ipilimumab (n = 44), atezolizumab (n = 40), cemiplimab (n = 24), durvalumab (n = 19), tislelizumab (n = 10), and avelumab (n = 3). Affected patients were predominantly males (67.8%) and over 60 years of age (70.1%). All eight ICIs showed positive disproportionality signals, with ROR values ranked descendingly as: cemiplimab > nivolumab > tislelizumab > pembrolizumab > ipilimumab > durvalumab > atezolizumab > avelumab. The median time of irBP onset was 165.2 (IQR: 56-410) days.

Conclusion: The study establishes a significant link between ICIs and BP. All ICIs increase BP risk. CTLA-4 inhibitors exhibited the most marked early risk concentration, highlighting the importance of early dermatologic evaluation after initiating CTLA-4 blockade.

目的:评估接受免疫检查点抑制剂(ICIs)治疗的患者发生大疱性类天疱疮(BP)的潜在风险,并利用美国食品和药物管理局不良事件报告系统(FAERS)数据库描述ICIs相关BP (irBP)的特征。方法:本研究利用FAERS数据库进行了歧化分析,时间跨度为2004-2025年第一季度。为了确保信号检测的鲁棒性,我们采用了四重分析方法,包括:(1)报告优势比(ROR),(2)比例报告比,(3)贝叶斯置信传播神经网络,(4)多项目伽玛泊松收缩算法。这些方法被系统地应用于评估接受ICIs治疗的患者发生BP的潜在风险。此外,对不良事件出现的时间特征进行了定量评估,以描述发病时间模式。结果:共发现850例irBP病例,包括与以下药物相关的报告:尼武单抗(n = 530)、派姆单抗(n = 180)、伊匹单抗(n = 44)、阿特唑单抗(n = 40)、塞米单抗(n = 24)、杜伐单抗(n = 19)、替利单抗(n = 10)和avelumab (n = 3)。患者以男性(67.8%)和60岁以上(70.1%)为主。所有8个ICIs均显示阳性的不均匀性信号,ROR值依次递减为:cemiplimab > nivolumab > tislelizumab > pembrolizumab > ipilimumab > durvalumab > atezolizumab > avelumab。irBP发病的中位时间为165.2 (IQR: 56-410)天。结论:本研究建立了ICIs与BP之间的重要联系。所有ici均增加BP风险。CTLA-4抑制剂表现出最显著的早期风险浓度,突出了启动CTLA-4阻断后早期皮肤病学评估的重要性。
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引用次数: 0
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