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Review: Special Issue: Real-world evidence on the use of GLP1 receptor agonists: Emerging concepts in obesity management: focus on glucagon receptor agonist combinations. 回顾:特刊:GLP1受体激动剂使用的真实证据:肥胖管理中的新兴概念:关注胰高血糖素受体激动剂组合。
IF 2.8 Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2025-07-24 eCollection Date: 2025-01-01 DOI: 10.7573/dic.2025-4-8
Sarah L Anderson

The global rise in obesity and its associated health risks has driven the need for more effective pharmacological treatments. Glucagon receptor (GCGR)-based multi-agonist drugs are emerging as promising treatments for obesity, with several in advanced stages of clinical development. Agents like mazdutide, pemvidutide, survodutide and retatrutide have demonstrated the ability to trigger significant weight loss in earlier phase trials, often surpassing the amount of weight loss obtained with existing therapies. Their potential to address obesity-related comorbidities, including type 2 diabetes mellitus and cardiovascular disease, positions them as important additions to future obesity treatment guidelines. As these GCGR-based multi-agonists advance through clinical trials, their impact on obesity management may be substantial, particularly for patients who have not achieved success with current medications or lifestyle interventions. Some are also being evaluated for cardiovascular outcomes, highlighting their relevance in populations at high risk with overweight and obesity. Key considerations as these drugs move forward in development to eventual approval include cost, access and long-term safety. This article is part of the Real-world evidence on the use of GLP1 receptor agonists Special Issue: https://www.drugsincontext.com/special_issues/real-world-evidence-on-the-use-of-glp1-receptor-agonists.

全球肥胖人数的增加及其相关的健康风险促使人们需要更有效的药物治疗。基于胰高血糖素受体(GCGR)的多重激动剂药物正在成为治疗肥胖的有希望的药物,其中一些已处于临床开发的后期阶段。在早期试验中,马都肽、培维肽、利托鲁肽等药物已被证明有能力引发显著的体重减轻,通常超过现有疗法获得的体重减轻量。它们有可能解决肥胖相关的合并症,包括2型糖尿病和心血管疾病,使它们成为未来肥胖治疗指南的重要补充。随着这些基于gcgr的多重激动剂通过临床试验取得进展,它们对肥胖管理的影响可能是巨大的,特别是对那些目前药物或生活方式干预未取得成功的患者。还对其中一些进行了心血管结果评估,强调了它们在超重和肥胖高危人群中的相关性。这些药物从开发到最终批准的关键考虑因素包括成本、可及性和长期安全性。这篇文章是关于GLP1受体激动剂使用的真实证据的一部分特刊:https://www.drugsincontext.com/special_issues/real-world-evidence-on-the-use-of-glp1-receptor-agonists。
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引用次数: 0
Simulated client study on the dispensing practices for narcotic and psychotropic medications in community drug outlets in Ethiopia. 埃塞俄比亚社区药品销售点麻醉药品和精神药物配药实践的模拟客户研究。
Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2025-07-16 eCollection Date: 2025-01-01 DOI: 10.7573/dic.2025-2-1
Tirsit Ketsela Zeleke, Minichil Chanie Worku, Bantayehu Addis Tegegne, Fasil Bayafers Tamene, Gebremariam Wulie Geremew, Samuel Agegnew Wondm, Aschalew Mulatu Tefera, Ayelign Eshete Fitgu, Tekletsadik Tekleslassie Alemayehu, Muluken Adela Alemu, Rahel Belete Abebe, Kale Gubae, Abraham Teym

Background: Dispensing prescription-only medications without a valid prescription poses significant public health risks, including inappropriate drug use, adverse drug reactions and medication dependence. Narcotics and psychotropic drugs are particularly vulnerable to misuse. Despite this, limited data exist on the dispensing practices of these medications at community drug retail outlets in Ethiopia. This study aimed to assess the extent and factors of non-prescription dispensing of narcotic and psychotropic medications at community drug retail outlets in Ethiopia.

Methods: An observational cross-sectional study was conducted using the simulated client method from June 1, 2023, to September 30, 2023, in Debre Markos town, Ethiopia. Three trained volunteer pharmacy professionals acted as simulated clients. A validated simulated client approach was used to request medications through three different scenarios: symptom-based (depression), direct request by name and request by presenting a medication package.

Results: A total of 109 requests were made by the simulated clients at 38 community drug retail outlets during three rounds of observations. The rates of non-prescription dispensing were 28.9% for depression simulation, 60.5% for direct name requests and 81.6% for package-based requests. A total of nine types of narcotic and psychotropic medications were dispensed without prescription, the most common of which were amitriptyline, followed by tramadol, carbamazepine, pethidine and haloperidol.

Conclusion: This study revealed a high prevalence of non-prescription dispensing of narcotic and psychotropic medications, particularly in response to assertive client requests. Urgent regulatory measures are needed to ensure adherence to prescription-only policies, especially for frequently dispensed drugs such as amitriptyline, tramadol and chlorpromazine.

背景:在没有有效处方的情况下分发仅凭处方的药物会造成重大的公共卫生风险,包括不适当的药物使用、药物不良反应和药物依赖。麻醉药品和精神药物特别容易被滥用。尽管如此,关于埃塞俄比亚社区药品零售网点这些药物配药做法的数据有限。本研究旨在评估埃塞俄比亚社区药品零售网点非处方发放麻醉药品和精神药品的程度和影响因素。方法:于2023年6月1日至2023年9月30日在埃塞俄比亚Debre Markos镇采用模拟客户方法进行观察性横断面研究。三名训练有素的志愿药学专业人员扮演模拟客户。一种经过验证的模拟客户方法通过三种不同的场景来请求药物:基于症状(抑郁症)、直接通过姓名请求和通过提供药物包请求。结果:在三轮观察中,38个社区药品零售网点的模拟客户共提出109次要求。抑郁症模拟的非处方配药率为28.9%,直接名称请求为60.5%,基于包装的请求为81.6%。无处方发放麻醉药品和精神药品共9种,以阿米替林最多,其次为曲马多、卡马西平、哌替啶和氟哌啶醇。结论:本研究揭示了麻醉药品和精神药物的非处方配药的高患病率,特别是在回应坚定的客户要求。需要采取紧急管理措施,以确保遵守仅限处方的政策,特别是对于阿米替林、曲马多和氯丙嗪等经常配发的药物。
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引用次数: 0
Evaluating the efficacy of curcumin plus serratiopeptidase formulation in inflammatory acne: a quasi-experimental study. 评价姜黄素加锯齿肽酶制剂治疗炎症性痤疮的疗效:一项准实验研究。
Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2025-07-09 eCollection Date: 2025-01-01 DOI: 10.7573/dic.2025-4-2
Shakila Junaid, Kiran Naz Khan, Farina Zameer, Muhammad Mudassir, Sadaf Bukhari, Neeta Maheshwary, Muhammad Athar Khan

Background: Acne vulgaris is one of the most common dermatological illnesses affecting people worldwide. In Pakistan, approximately 9.4% of the population and between 5% and 16% of young adults are affected by acne vulgaris. Conventional therapies (topical benzoyl peroxide, retinoids, antibiotics and oral isotretinoin) are effective but limited by antibiotic resistance and side effects. Curcumin (a natural anti-inflammatory/antimicrobial from turmeric) and serratiopeptidase (a proteolytic enzyme with anti-inflammatory, anti-oedematous and antibiofilm properties) each show promise in acne treatment. This article evaluates the efficacy of a combined oral curcumin plus serratiopeptidase formulation as an adjunct to inflammatory acne therapy.

Methods: Fifty individuals with mild-to-moderate symptoms of inflammatory acne participated in this quasi-experimental study. They were allocated to standard therapy alone (topical regimen: benzoyl peroxide 5% and adapalene 0.1% gel; oral doxycycline 100 mg once daily) or standard therapy plus a daily curcumin (500 mg) + serratiopeptidase (10 mg) supplement (adjunctive therapy). Acne severity was assessed using a visual analogue scale (VAS) and lesion improvement scale at baseline, 1 week and 2 weeks of treatment. Data were analysed with parametric tests after normalization (log transformation), with significance set at p<0.05.

Results: Baseline characteristics were similar between groups (mean age: 23 years; 66% female). Both groups showed significant improvement in mean VAS (from 7.5 at baseline to 3.1 at 2 weeks; p<0.001). The adjunctive therapy group achieved a markedly higher complete/near-complete improvement rate by week 2 (84% versus 28%; p<0.001). No serious adverse events occurred.

Conclusion: Curcumin plus serratiopeptidase, as an adjunct to standard therapy significantly, accelerated the resolution of inflammatory acne lesions within 2 weeks, with excellent tolerability. This novel combination targets inflammatory pathways and could reduce reliance on prolonged antibiotics. Larger, longer-term studies are recommended to confirm these findings and evaluate effects on relapse and scarring.

背景:寻常痤疮是世界范围内最常见的皮肤病之一。在巴基斯坦,大约9.4%的人口和5%至16%的年轻人患有寻常性痤疮。常规疗法(外用过氧化苯甲酰、类维生素a、抗生素和口服异维甲酸)是有效的,但受抗生素耐药性和副作用的限制。姜黄素(一种来自姜黄的天然抗炎/抗菌物质)和serratiopeptidase(一种具有抗炎、抗水肿和抗生物膜特性的蛋白水解酶)在治疗痤疮方面都有希望。这篇文章评估了联合口服姜黄素加锯齿肽酶制剂作为辅助炎性痤疮治疗的疗效。方法:50例轻度至中度炎症性痤疮患者参加准实验研究。他们被分配到单独的标准治疗(局部治疗方案:过氧化苯甲酰5%和阿达帕林0.1%凝胶;口服强力霉素100毫克,每日一次)或标准治疗加每日姜黄素(500毫克)+血清肽酶(10毫克)补充(辅助治疗)。在基线、治疗1周和治疗2周时,采用视觉模拟量表(VAS)和病变改善量表评估痤疮严重程度。经归一化(对数变换)后,对数据进行参数检验分析,结果具有显著性集:组间基线特征相似(平均年龄:23岁;66%的女性)。两组的平均VAS均有显著改善(从基线时的7.5提高到2周时的3.1;pversus 28%;结论:姜黄素加serratioptidase作为标准治疗的辅助治疗,可在2周内显著加速炎性痤疮病变的消退,且耐受性极好。这种新的组合针对炎症途径,可以减少对长期抗生素的依赖。建议进行更大规模、更长期的研究,以证实这些发现,并评估对复发和瘢痕形成的影响。
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引用次数: 0
Prevention of epiretinal membrane traction progression with topical indomethacin treatment: a case report and mini literature review. 局部吲哚美辛治疗预防视网膜前膜牵拉进展:1例报告及文献复习。
Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2025-06-26 eCollection Date: 2025-01-01 DOI: 10.7573/dic.2025-2-4
Amedeo Lucente, Andrea Taloni, Federico Fava, Giuseppe Giannaccare

This case report explores the potential of 0.5% indomethacin eye drops (Indo0.5) in preventing the progression of epiretinal membrane traction. A 72-year-old patient with progressive vitreomacular traction was treated with Indo0.5, leading to a significant decrease in intraretinal cyst within 8 months, complete resorption after 16 months and full restoration of the retinal profile after 22 months. A mini literature review highlights the anti-inflammatory effects of indomethacin for various conditions affecting the anterior segment and suggests that the 0.5% concentration may also be effective in managing retinal inflammation. Indo0.5 could be a non-invasive option for slowing epiretinal membrane traction progression, supporting further research to optimize treatment strategies.

本病例报告探讨0.5%吲哚美辛滴眼液(Indo0.5)预防视网膜前膜牵拉进展的潜力。一例72岁的进行性玻璃体黄斑牵引患者采用Indo0.5治疗,8个月内视网膜内囊肿明显减少,16个月后完全吸收,22个月后视网膜轮廓完全恢复。一项小型文献综述强调了吲哚美辛对影响前段的各种疾病的抗炎作用,并表明0.5%浓度的吲哚美辛也可能有效地治疗视网膜炎症。Indo0.5可能是减缓视网膜前膜牵引进展的非侵入性选择,支持进一步研究以优化治疗策略。
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引用次数: 0
Long sustained response during second-line pembrolizumab plus lenvatinib in a patient with recurrent endometrial carcinoma: a case report. 复发性子宫内膜癌患者的二线派姆单抗加lenvatinib的长期持续反应:1例报告。
Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2025-06-24 eCollection Date: 2025-01-01 DOI: 10.7573/dic.2025-4-3
Laura Fabbri, Linda Galvani, Claudio Zamagni

The combination of the immune-checkpoint inhibitor pembrolizumab plus lenvatinib, an angiogenesis inhibitor targeting VEGFR/FGFR, has been approved as standard second-line treatment for patients with recurrent or metastatic endometrial cancer progressed to first-line platinum-based chemotherapy regardless of mismatch repair status and based on the results of the KEYNOTE-775 trial. This article reports on the case of a middle-aged woman with advanced microsatellite stable, p53-mutant endometrial cancer who achieved a meaningful and sustained partial response, with good tolerability, to second-line treatment with pembrolizumab plus lenvatinib. This favourable outcome was compared with efficacy and toxicity data available in the current literature. Pembrolizumab plus lenvatinib can significantly prolong progression-free survival, especially in patients with a negative prognostic molecular profile, who at most can benefit from combining different therapeutic strategies. The heterogeneous treatment-related adverse events landscape should not discourage therapy prescription because most adverse events are easily manageable following simple precautions. This article is part of the New treatment options for advanced endometrial carcinoma Special Issue: https://www.drugsincontext.com/special_issues/new-treatment-options-for-advanced-endometrial-carcinoma.

基于KEYNOTE-775试验的结果,免疫检查点抑制剂pembrolizumab联合lenvatinib(一种靶向VEGFR/FGFR的血管生成抑制剂)已被批准作为复发或转移性子宫内膜癌进展为一线铂基化疗的标准二线治疗,无论错配修复状态如何。本文报道了一名患有晚期微卫星稳定p53突变子宫内膜癌的中年妇女,她对派姆单抗加lenvatinib的二线治疗取得了有意义和持续的部分缓解,具有良好的耐受性。这一有利结果与目前文献中可用的疗效和毒性数据进行了比较。Pembrolizumab联合lenvatinib可以显著延长无进展生存期,特别是对于预后不良分子谱的患者,他们最多可以从不同的治疗策略中获益。异质性治疗相关的不良事件景观不应该阻碍治疗处方,因为大多数不良事件是很容易管理的简单的预防措施。这篇文章是晚期子宫内膜癌新治疗方案的一部分特刊:https://www.drugsincontext.com/special_issues/new-treatment-options-for-advanced-endometrial-carcinoma。
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引用次数: 0
Overcoming disease progression in advanced endometrial cancer: a clinical case of sequential therapies. 克服晚期子宫内膜癌的疾病进展:序贯治疗的临床病例。
Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2025-06-24 eCollection Date: 2025-01-01 DOI: 10.7573/dic.2025-4-5
Amedeo Cefaliello, Angela Grieco, Roberto Buonaiuto, Valeria Forestieri

Immunotherapy has revolutionized the treatment landscape for solid tumours. Here, we describe the case of a 69-year-old woman with advanced endometrial cancer (EC) who achieved prolonged disease control with immunotherapy. The patient was diagnosed with stage IIIC EC in February 2020 and was treated with carboplatin and paclitaxel, followed by radiotherapy. Relapses occurred in February 2021 (treated with doxorubicin and palliative radiotherapy) and July 2022 (treated with a carboplatin rechallenge). Pembrolizumab and lenvatinib were started in November 2022. Although the initial scan showed progressive disease, restaging 2 months later showed stable disease, which was maintained on pembrolizumab and lenvatinib until progression in October 2024. This article is part of the New treatment options for advanced endometrial carcinoma Special Issue: https://www.drugsincontext.com/special_issues/new-treatment-options-for-advanced-endometrial-carcinoma.

免疫疗法已经彻底改变了实体肿瘤的治疗前景。在这里,我们描述了一个69岁晚期子宫内膜癌(EC)妇女的病例,她通过免疫治疗获得了长期的疾病控制。该患者于2020年2月被诊断为IIIC期EC,并接受卡铂和紫杉醇治疗,随后进行放疗。复发发生在2021年2月(接受阿霉素和姑息性放疗治疗)和2022年7月(再次接受卡铂治疗)。派姆单抗和lenvatinib于2022年11月开始。虽然最初的扫描显示疾病进展,但2个月后重新扫描显示疾病稳定,并在派姆单抗和lenvatinib的治疗下维持,直到2024年10月病情进展。这篇文章是晚期子宫内膜癌新治疗方案的一部分特刊:https://www.drugsincontext.com/special_issues/new-treatment-options-for-advanced-endometrial-carcinoma。
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引用次数: 0
Advancing endometrial cancer treatment: exploring immunotherapy and tyrosine kinase inhibitors through clinical cases. 推进子宫内膜癌治疗:通过临床病例探索免疫疗法和酪氨酸激酶抑制剂。
Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2025-06-24 eCollection Date: 2025-01-01 DOI: 10.7573/dic.2025-4-4
Vanda Salutari

Endometrial cancer (EC) is the most common gynaecological malignancy in developed countries, with advanced-stage disease posing significant therapeutic challenges. Standard treatments, including surgery, radiotherapy and chemotherapy, have limited efficacy in recurrent or metastatic cases, necessitating novel therapeutic approaches. Recent molecular classifications of EC have identified subtypes with distinct prognostic and therapeutic implications, particularly those with high immunogenicity. Immunotherapy, specifically immune-checkpoint inhibitors targeting PD-1/PD-L1, has transformed EC treatment. The combination of pembrolizumab, an anti-PD-1 monoclonal antibody, and lenvatinib, a tyrosine kinase inhibitor (TKI), has demonstrated superior efficacy over chemotherapy in the pivotal KEYNOTE-775 trial, significantly improving progression-free and overall survival in advanced EC. Additionally, dostarlimab has shown promise as a monotherapy for mismatch repair-deficient EC, expanding treatment options. This special series in Drugs in Context explores these advancements through clinical case studies, highlighting real-world applications of immunotherapy and TKIs. Cases illustrate treatment responses, challenges in managing toxicities and the evolving role of molecular profiling in personalizing therapy. As research progresses, integrating immunotherapy and TKIs into routine practice is expected to improve outcomes for patients with advanced EC, offering new hope in a previously limited therapeutic landscape. This article is part of the New treatment options for advanced endometrial carcinoma Special Issue: https://www.drugsincontext.com/special_issues/new-treatment-options-for-advanced-endometrial-carcinoma.

子宫内膜癌(EC)是发达国家最常见的妇科恶性肿瘤,晚期疾病带来了重大的治疗挑战。标准治疗,包括手术、放疗和化疗,对复发或转移病例的疗效有限,需要新的治疗方法。最近的EC分子分类已经确定了具有不同预后和治疗意义的亚型,特别是那些具有高免疫原性的亚型。免疫疗法,特别是针对PD-1/PD-L1的免疫检查点抑制剂,已经改变了EC的治疗。在关键的KEYNOTE-775试验中,pembrolizumab(一种抗pd -1单克隆抗体)和lenvatinib(一种酪氨酸激酶抑制剂(TKI))的联合治疗显示出优于化疗的疗效,显着提高了晚期EC的无进展和总生存期。此外,dostarlimumab已显示出作为错配修复缺陷EC的单药治疗的前景,扩大了治疗选择。本专题系列通过临床案例研究探讨了这些进展,重点介绍了免疫疗法和tki在现实世界中的应用。病例说明了治疗反应,管理毒性的挑战和分子谱在个性化治疗中的不断发展的作用。随着研究的进展,将免疫疗法和tki整合到常规实践中有望改善晚期EC患者的预后,为以前有限的治疗前景带来新的希望。这篇文章是晚期子宫内膜癌新治疗方案的一部分特刊:https://www.drugsincontext.com/special_issues/new-treatment-options-for-advanced-endometrial-carcinoma。
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引用次数: 0
Sustained disease control with pembrolizumab-lenvatinib in a patient with heavily pre-treated recurrent endometrial carcinoma: a case report. 派姆单抗-lenvatinib在重度预处理复发性子宫内膜癌患者中的持续疾病控制:1例报告。
Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2025-06-24 eCollection Date: 2025-01-01 DOI: 10.7573/dic.2025-4-6
Alessia Lancianese, Elena Maccaroni, Laura Zepponi, Riccardo Giampieri, Rossana Berardi

Advanced endometrial carcinoma (EC) is typically associated with poor prognosis. However, recent advances have revolutionized therapeutic strategies. In patients with microsatellite stable (MSS) advanced EC, pembrolizumab plus lenvatinib have significantly improved overall survival, progression-free survival and response rate compared to standard chemotherapy. We describe the case of a 63-year-old woman with advanced endometrioid adenocarcinoma exhibiting mismatch repair proficiency (pMMR) and MSS who started treatment with pembrolizumab and lenvatinib after failing multiple lines of therapy. The patient had a favourable response, with mild side effects, and continues to receive treatment. Our experience supports pembrolizumab plus lenvatinib as a promising therapeutic option for patients with advanced recurrent EC with pMMR/MSS. This article is part of the New treatment options for advanced endometrial carcinoma Special Issue: https://www.drugsincontext.com/special_issues/new-treatment-options-for-advanced-endometrial-carcinoma.

晚期子宫内膜癌(EC)通常伴有不良预后。然而,最近的进展已经彻底改变了治疗策略。在微卫星稳定(MSS)晚期EC患者中,与标准化疗相比,派姆单抗加lenvatinib显著提高了总生存期、无进展生存期和反应率。我们描述了一例63岁晚期子宫内膜样腺癌女性,表现出错配修复能力(pMMR)和MSS,她在多次治疗失败后开始使用派姆单抗和lenvatinib治疗。患者有良好的反应,副作用轻微,并继续接受治疗。我们的经验支持派姆单抗联合lenvatinib作为晚期复发性EC伴pMMR/MSS患者的一种有希望的治疗选择。这篇文章是晚期子宫内膜癌新治疗方案的一部分特刊:https://www.drugsincontext.com/special_issues/new-treatment-options-for-advanced-endometrial-carcinoma。
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引用次数: 0
Pseudoprogression and improvement of quality of life in a patient with advanced endometrial cancer treated with immunotherapy: a case report. 免疫疗法治疗晚期子宫内膜癌患者的假进展和生活质量的改善:一例报告。
Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2025-06-24 eCollection Date: 2025-01-01 DOI: 10.7573/dic.2025-4-7
Valentina Tuninetti, Roberta Danese, Amedeo Calvo, Marco Bellero, Lavinia Bianco, Valentina Ariu, Maria Grazia Ruo Redda, Paola Campisi, Alessandra Bianco, Giovanni De Rosa, Massimo Petracchini, Giorgio Valabrega

Until recently, treatment options for patients with recurrent or metastatic endometrial cancer (EC) were limited. First-line treatment is usually based on carboplatin and paclitaxel and there was no standard second-line therapy following platinum failure. However, the introduction of immunotherapy has expanded both first-line and later-line options for EC and made determination of mismatch repair status essential. We describe the case of a 56-year-old woman with deficient mismatch repair/microsatellite instability EC who did not respond to first-line treatment with carboplatin and paclitaxel but had a high response to subsequent immunotherapy with dostarlimab. There was initial pseudoprogression of one target lesion but marked improvement in quality of life. This article is part of the New treatment options for advanced endometrial carcinoma Special Issue: https://www.drugsincontext.com/special_issues/new-treatment-options-for-advanced-endometrial-carcinoma.

直到最近,复发或转移性子宫内膜癌(EC)患者的治疗选择是有限的。一线治疗通常基于卡铂和紫杉醇,在铂治疗失败后没有标准的二线治疗。然而,免疫疗法的引入扩大了EC的一线和后期治疗选择,并使错配修复状态的测定变得至关重要。我们描述了一名56岁的女性,患有缺陷错配修复/微卫星不稳定性EC,她对卡铂和紫杉醇的一线治疗没有反应,但对随后的多斯塔利单抗免疫治疗有很高的反应。最初有一个目标病变的假进展,但生活质量明显改善。这篇文章是晚期子宫内膜癌新治疗方案的一部分特刊:https://www.drugsincontext.com/special_issues/new-treatment-options-for-advanced-endometrial-carcinoma。
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引用次数: 0
Efficacy and safety of dupilumab in the treatment of moderate-to-severe atopic dermatitis: a real-life study. dupilumab治疗中重度特应性皮炎的有效性和安全性:一项现实研究
Q2 Pharmacology, Toxicology and Pharmaceutics Pub Date : 2025-06-19 eCollection Date: 2025-01-01 DOI: 10.7573/dic.2025-3-5
Mariele Morandin Lopes, Ana Paula Moschione Castro, Túlio Morandin Ferrisse, Jorge Kalil, Ariana Campos Yang, Fabio Morato Castro

Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease that occurs more frequently in children but can also manifest in adults. Approximately 15-20% of children are affected worldwide. Persistent AD may be present in approximately 50% of patients during childhood. Despite the pivotal studies, there are not enough real-life studies using dupilumab, especially in Latin American countries. This study was performed in Brazil and is essential for evaluating this population. The objective of the study was to understand the real-life efficacy and safety of using dupilumab in patients with moderate or severe AD.

Methods: Observational, descriptive study based on the biweekly evaluation of 100 patients using the immunobiological dupilumab in an infusion clinic for 16 consecutive weeks. Data collection was conducted from June 2020 to March 2022. To evaluate each sequential SCORing Atopic Dermatitis (SCORAD) value, a repeated measures analysis of variance was performed, with a value of p<0.0001.

Results: There was a significant decrease in SCORAD values from the second week of treatment. In 16 weeks, 80% of patients achieved SCORAD-50 and 37% achieved SCORAD-75. Regarding adverse effects, 22% of patients had conjunctivitis, 11% had facial erythema, 1% had herpes simplex and 1% had hypochromia at the application site. Regarding efficacy, the results showed a reduction in SCORAD value by 67.4% in 16 weeks, 72% of patients achieved SCORAD <25, that is, mild atopic dermatitis.

Conclusion: This study identified that dupilumab was effective in real life, even outside of the controlled environments of pivotal studies. Additionally, despite conjunctivitis being a common adverse event, no patient required treatment discontinuation.

背景:特应性皮炎(AD)是一种慢性炎症性皮肤病,常见于儿童,但也可在成人中表现出来。全世界约有15-20%的儿童受到影响。大约50%的患者在儿童期可能存在持续性AD。尽管有这些关键的研究,但使用dupilumab的现实研究还不够,特别是在拉丁美洲国家。这项研究是在巴西进行的,对评估这一人群至关重要。该研究的目的是了解在中度或重度AD患者中使用dupilumab的现实疗效和安全性。方法:观察性描述性研究,对100例连续16周在输注诊所使用免疫生物学杜匹单抗的患者进行双周评估。数据收集时间为2020年6月至2022年3月。为了评估每个顺序评分特应性皮炎(SCORAD)值,进行重复测量方差分析,结果:从治疗第二周开始,SCORAD值显着下降。16周后,80%的患者达到SCORAD-50, 37%达到SCORAD-75。在不良反应方面,22%的患者出现结膜炎,11%的患者出现面部红斑,1%的患者出现单纯疱疹,1%的患者出现涂抹部位的低色素。关于疗效,结果显示在16周内,SCORAD值降低了67.4%,72%的患者达到了SCORAD。结论:本研究确定了杜匹单抗在现实生活中是有效的,即使在关键研究的受控环境之外。此外,尽管结膜炎是一种常见的不良事件,但没有患者需要停止治疗。
{"title":"Efficacy and safety of dupilumab in the treatment of moderate-to-severe atopic dermatitis: a real-life study.","authors":"Mariele Morandin Lopes, Ana Paula Moschione Castro, Túlio Morandin Ferrisse, Jorge Kalil, Ariana Campos Yang, Fabio Morato Castro","doi":"10.7573/dic.2025-3-5","DOIUrl":"10.7573/dic.2025-3-5","url":null,"abstract":"<p><strong>Background: </strong>Atopic dermatitis (AD) is a chronic inflammatory skin disease that occurs more frequently in children but can also manifest in adults. Approximately 15-20% of children are affected worldwide. Persistent AD may be present in approximately 50% of patients during childhood. Despite the pivotal studies, there are not enough real-life studies using dupilumab, especially in Latin American countries. This study was performed in Brazil and is essential for evaluating this population. The objective of the study was to understand the real-life efficacy and safety of using dupilumab in patients with moderate or severe AD.</p><p><strong>Methods: </strong>Observational, descriptive study based on the biweekly evaluation of 100 patients using the immunobiological dupilumab in an infusion clinic for 16 consecutive weeks. Data collection was conducted from June 2020 to March 2022. To evaluate each sequential SCORing Atopic Dermatitis (SCORAD) value, a repeated measures analysis of variance was performed, with a value of <i>p</i><0.0001.</p><p><strong>Results: </strong>There was a significant decrease in SCORAD values from the second week of treatment. In 16 weeks, 80% of patients achieved SCORAD-50 and 37% achieved SCORAD-75. Regarding adverse effects, 22% of patients had conjunctivitis, 11% had facial erythema, 1% had herpes simplex and 1% had hypochromia at the application site. Regarding efficacy, the results showed a reduction in SCORAD value by 67.4% in 16 weeks, 72% of patients achieved SCORAD <25, that is, mild atopic dermatitis.</p><p><strong>Conclusion: </strong>This study identified that dupilumab was effective in real life, even outside of the controlled environments of pivotal studies. Additionally, despite conjunctivitis being a common adverse event, no patient required treatment discontinuation.</p>","PeriodicalId":11362,"journal":{"name":"Drugs in Context","volume":"14 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12201941/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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Drugs in Context
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