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Protocol for the Development of a Core Outcome Set for Inherited Ichthyosis. 制定遗传性鱼鳞病(COSII)核心结局集的方案。
IF 2.7 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-01-01 Epub Date: 2025-04-29 DOI: 10.1159/000546035
Vanya Rossel, S Vanya J Rossel, Jason Shourick, Maria C Bolling, Anna M G Pasmooij, Karin Veldman, Jamie J Kirkham, Juliette Mazereeuw-Hautier, Antoni H Gostyński

Introduction: Inherited ichthyosis comprises a group of rare keratinization disorders caused by abnormal epidermal barrier function. Ichthyosis is yet incurable and current treatments mainly focus on alleviating symptoms such as scaling, erythema and pruritus. Recent developments show promising results for interventions based on the immune-phenotype like biologicals or pathogenesis-based therapies such as gene therapy. However, the lack of uniform reporting and variety of treatment outcomes may complicate performing and comparing efficacy studies. The core outcome set for inherited ichthyosis (COSII) aims to develop a core outcome set (COS), i.e., the minimum of outcomes that should be measured and reported in observational and interventional studies, including a minimum set of baseline characteristics. Methods: The COSII project will follow the guidelines from the Core Outcome Measures in Effectiveness Trials (COMET) initiative, including the Core Outcome Set-Standards for Development (COS-STAD) recommendations and the Core Outcome Set Standardised Protocol (COS-STAP) checklist. The COS development methodology, including this protocol, follows the guidance of the CHORD COUSIN Collaboration 'C3'. The first stage of this project involves identifying a possible list of outcomes through performing a scoping literature review and conducting interviews with patient(s) (representatives). This list will be presented to five different stakeholder groups: healthcare professionals, researchers, patient(s) (representatives), industry representatives, and regulators. All stakeholders will rate the importance of each outcome in a three-round eDelphi survey. Ultimately, a virtual consensus meeting will be convened to finalize the COS. Ethical approval was obtained prior to the start of this project from the Medical Ethics Committee Board at Maastricht University Medical Centre (METC 2022-3192). Informed consent will be asked prior to enrolment in the eDelphi. This study is registered with the COMET. The results will be distributed via a peer-reviewed journal, communicated to all relevant parties and showcased at national and international conferences. Conclusion: This will be the first COS for inherited ichthyosis research in accordance with the Core Outcome Measures in Effectiveness Trials initiative. The development of a COS aims to improve the consistency of reporting and the heterogeneity of outcomes in ichthyosis research.

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遗传性鱼鳞病是由表皮屏障功能异常引起的一组罕见的角化疾病。鱼鳞病是无法治愈的,目前的治疗主要集中在减轻症状,如鳞屑,红斑和瘙痒。最近的发展表明,基于免疫表型的干预措施(如生物制剂)或基于致病机制的治疗(如基因治疗)都有希望取得成果。然而,缺乏统一的报告和治疗结果的多样性可能会使疗效研究的实施和比较复杂化。遗传性鱼鳞病(COSII)的核心结果集旨在制定一个核心结果集(COS),即在有效性研究中应测量和报告的最小结果集,包括一组最小基线特征。方法COSII项目将遵循有效性试验核心结果测量(COMET)倡议的指导方针,包括发展核心结果集标准(COS-STAD)建议和核心结果集标准化方案(COS-STAP)清单。COS开发方法,包括本协议,遵循CHORD COUSIN协作“C3”的指导。该项目的第一阶段包括通过进行范围文献综述和与患者(代表)进行访谈来确定可能的结果列表。这份清单将提交给五个不同的利益相关者群体:医疗保健专业人员、研究人员、患者代表、行业代表和监管机构。所有利益相关者将在三轮eDelphi调查中评估每个结果的重要性。最后,将召开一次虚拟协商一致会议,以最后确定COS。在该项目开始之前,已获得马斯特里赫特大学医学中心医学伦理委员会委员会(METC 2022-3192)的伦理批准。在参加eDelphi之前,将征求知情同意。这项研究已在彗星注册。研究结果将通过同行评议的期刊发布,传达给所有相关方,并在国内和国际会议上展示。根据有效性试验的核心结局指标,这将是遗传性鱼鳞病研究的第一个COS。COS的发展旨在提高鱼鳞病研究报告的一致性和结果的异质性。
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引用次数: 0
Value of Diagnosis and Management for Skin Lesions by Integration of High-Frequency Ultrasound in Daily Practices: A Prospective Study. 高频超声在日常实践中诊断和治疗皮肤病变的价值:一项前瞻性研究。
IF 2.7 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-01-01 Epub Date: 2025-06-12 DOI: 10.1159/000546224
An-Qi Zhu, Xue-Wen Chen, Wei-Chen Xu, Yin-Cheng Gao, Jia Liu, Ruo-Yi Lin, Yu-Jing Zhao, Hui-Jun Fu, Hui-Xiong Xu, Li-Ping Sun, Qiao Wang, Le-Hang Guo

Introduction: The aim of this study was to identify whether high-frequency ultrasound (HFUS) could correct the misdiagnosis, confirm equivocal skin lesions, and improve the management after clinical examination.

Methods: In this study, a total of 574 skin lesions from 552 patients were prospectively enrolled. The specific diagnosis and management decisions (treatment/excision, observation) determined by HFUS after clinical examination were recorded during the clinical practice. The area under the receiver operating characteristic curve, accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and the number needed to excise (NNE) before and after HFUS were also evaluated. The pathological results were conducted as golden standards to compare the performance.

Results: Among the 574 skin lesions, 290 (50.5%) were malignancies and 284 (49.5%) were benign. The diagnostic accuracy was improved from 77.5% to 90.8% after the HFUS examination. There were 44 lesions wrongfully diagnosed by the initial clinical diagnosis, whereas 28 of 44 (63.6%) lesions were correctly identified by HFUS examination. Of 85 lesions categorized as equivocal skin lesions by clinical examination, 65 (76.5%) were diagnosed correctly after HFUS. Lesion management changed in 72 of 574 (12.5%) after HFUS. Among these lesions, HFUS saved 22 unnecessary excisions and prompted the treatment of 30 malignancies that would be observed based on clinical examination alone. Additionally, the NNE was reduced by 15.4% (NNE, 0.828) after HFUS and 4.6% (NNE, 0.933) before HFUS.

Conclusions: HFUS could be a valuable tool in diagnosing equivocal skin lesions, identifying skin cancers missed by clinical examination, and reducing unnecessary excision of benign lesions while improving NNE.

目的:探讨高频超声(HFUS)在临床检查后是否能纠正误诊,确认模棱性皮损,改善处理。方法:在这项研究中,来自552例患者的574个皮肤病变被前瞻性纳入。在临床实践中记录临床检查后HFUS确定的具体诊断和管理决策(治疗/切除、观察)。并对患者工作特征曲线下面积(AUC)、准确性、敏感性、特异性、阳性预测值(PPV)、阴性预测值(NPV)、HFUS前后需要切除的数量(NNE)进行评价。以病理结果为金标准进行比较。结果:574例皮损中,恶性290例(50.5%),良性284例(49.5%)。HFUS检查后的诊断准确率由77.5%提高到90.8%。临床初诊误诊44例,HFUS检查正确诊断28例(63.6%)。85例临床诊断为模棱两可的皮肤病变,65例(76.5%)经HFUS诊断正确。574例患者中72例(12.5%)在HFUS后病变处理发生改变。在这些病变中,HFUS避免了22例不必要的切除,并促进了30例仅凭临床检查就可观察到的恶性肿瘤的治疗。此外,高负荷治疗后NNE减少15.4% (NNE, 0.828),高负荷治疗前NNE减少4.6% (NNE, 0.933)。结论:HFUS可作为一种有价值的工具,用于诊断模棱两可的皮肤病变,识别临床检查遗漏的皮肤癌,减少不必要的良性病变切除,同时改善NNE。
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引用次数: 0
Artificial Intelligence-Driven Skin Aging Simulation as a Novel Skin Cancer Prevention. 人工智能驱动的皮肤老化模拟是一种新型皮肤癌预防方法。
IF 3 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-01-01 Epub Date: 2024-10-14 DOI: 10.1159/000541943
Lorena Gantenbein, Sara Elisa Cerminara, Julia-Tatjana Maul, Alexander A Navarini, Lara Valeska Maul
<p><strong>Introduction: </strong>Skin cancer, a prevalent cancer type among fair-skinned patients globally, poses a relevant public health concern due to rising incidence rates. Ultraviolet (UV) radiation poses a major risk factor for skin cancer. However, intentional tanning associated with sunburns remains a common practice, notably among female adults. Appropriate prevention campaigns targeting children and adolescents are needed to improve sun protection behavior particularly in these age groups. The aim of our study was to investigate if an AI-based simulation of facial skin aging can enhance sun protection behavior in female adults.</p><p><strong>Methods: </strong>In this single-center, prospective, observational pilot study at Department of Dermatology at the University Hospital of Basel, we took photographs of healthy young females' faces with a VISIA-CR camera (Version 8.2; Canfield Scientific Inc., Parsippany, NJ, USA) between February and March 2021. Digital images were performed in three angles (straight, left 45°, and right 45°). All participants received an AI-based simulation of their facial skin with continuous aging to 80 years. A newly created anonymous questionnaire capturing participants' sociodemographic data and also tanning and sun protection behavior was completed in pre- and post-aging simulation. To observe long-term effects, a 2-year follow-up was conducted between March and April 2023.</p><p><strong>Results: </strong>The 60 participants (mean age 23.6 ± 2.5 years) evaluated the importance of sun protection significantly higher after skin aging simulation with VISIA-CR camera (p < 0.0001; 95% CI: 8.2-8.8). Post-intervention, 91.7% (55/60) of the females were motivated to reduce UV exposure and to intensify UV protection in the future since the individual UV-dependent risk was perceived significantly higher (p < 0.001; 95% CI: 5.9-6.7). At 2-year follow-up, 96% (24/25) indicated persistent effort reducing UV exposure. The preference for SPF 50+ sunscreen increased to 46.7% (28/65) directly after the skin aging simulation and continued to rise up to 60.0% (15/25) after 2 years.</p><p><strong>Conclusions: </strong>Our data emphasize the potential of AI-assisted photoaging interventions to enhance motivation for UV protection in the short and the long term. We encourage that different age and gender groups are addressed in a personalized, generation-specific manner with the appropriate media and by considering the Hawthorne effect. Campaigns with visual AI support can improve the intent of cancer-preventative behavior.</p><p><strong>Introduction: </strong>Skin cancer, a prevalent cancer type among fair-skinned patients globally, poses a relevant public health concern due to rising incidence rates. Ultraviolet (UV) radiation poses a major risk factor for skin cancer. However, intentional tanning associated with sunburns remains a common practice, notably among female adults. Appropriate prevention campaigns targeting childr
导言:皮肤癌是全球皮肤白皙的患者中常见的癌症类型,由于发病率不断上升,已成为一个相关的公共卫生问题。紫外线(UV)辐射是皮肤癌的主要风险因素。然而,与晒伤相关的故意晒黑仍是一种常见的做法,尤其是在成年女性中。 需要针对儿童和青少年开展适当的预防活动,以改善他们的防晒行为,尤其是在这些年龄组中。我们的研究旨在探讨基于人工智能的面部皮肤老化模拟是否能提高成年女性的防晒行为:在巴塞尔大学医院皮肤科进行的这项单中心前瞻性观察试点研究中,我们在 2021 年 2 月至 3 月期间使用 VISIA-CR 相机(Canfield Scientific Inc.数字图像从三个角度(直线、左 45°、右 45°)进行拍摄。所有参与者都接受了基于人工智能的面部皮肤模拟,并持续衰老至 80 岁。在模拟老化前后,参与者填写了一份新制作的匿名问卷,其中包括社会人口学数据以及日晒和防晒行为。为了观察长期效果,在 2023 年 3 月至 4 月期间进行了为期 2 年的跟踪调查:60名参与者(平均年龄为23.6±2.5岁)在使用VISIA-CR相机模拟皮肤老化后,对防晒重要性的评价明显提高(p<0.0001; 95%-CI:8.2-8.8)。干预后,91.7%(55/60)的女性有动力减少紫外线照射,并在未来加强紫外线防护,因为她们认为个人紫外线依赖风险明显增加(p<0.001; 95%-CI:5.9-6.7)。在两年的随访中,96%(24/25)的受访者表示将继续努力减少紫外线照射。皮肤老化模拟后,SPF50+防晒霜的偏好直接上升到46.7%(28/65),两年后继续上升到60.0%(15/25):我们鼓励针对不同年龄和性别的群体,通过适当的媒体和考虑霍桑效应,采取个性化的、针对特定世代的方式。有视觉人工智能支持的宣传活动可以提高防癌行为的积极性。
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引用次数: 0
Erratum. 勘误表。
IF 2.7 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-01-01 Epub Date: 2025-06-06 DOI: 10.1159/000545632
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引用次数: 0
X-Ray Therapy of Skin Cancer at Critical Facial Sites: Results of a Tertiary Referral Center. 关键面部部位皮肤癌的x射线治疗:三级转诊中心的结果。
IF 2.7 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-01-01 Epub Date: 2025-08-26 DOI: 10.1159/000548154
Sophie Tschopp, Amélie Ciernik, Reinhard Dummer, Laurence Imhof

Background: Therapeutic management of skin cancer (SC) in the "H-area" of the face is challenging due to the demands of function, cosmesis, and efficacy.

Objective: To evaluate the efficacy and safety of superficial radiotherapy (RT) for SC in the "H-area" of the face and to identify predictors of recurrence.

Methods: Retrospective analysis of patients with SC in the "H-area" of the face treated with superficial RT at the University Hospital of Zurich, Switzerland, between 2010 and 2021. The study included cases of basal cell carcinoma (BCC), squamous cell carcinoma (SCC), in situ SCC (isSCC), lentigo maligna melanoma (LMM), lentigo maligna (LM), and primary cutaneous T/B-cell lymphoma.

Results: We identified 546 lesions in 382 patients. Estimated relapse rates at 5 years were lowest for SCC (3.2%), isSCC (1.9%), and BCC (9.7%), while LMM and LM showed estimated relapse rates of 28.9% and 35.0%, respectively. Significant predictive factors for overall recurrence were increased Common Terminology Criteria for Adverse Events (CTCAE) grades with a hazard ratio (HR) of 1.9 (1.1-3.4) and the treatment of secondary lesions with an HR of 2.6 (1.4-5.1).

Conclusion: RT is a valuable treatment option for malignant skin tumors, especially non-melanoma SC, in high-risk areas, including the facial "H-area," providing favorable results with minimal side effects.

背景:面部“h区”皮肤癌(SC)的治疗管理由于功能、美容和疗效的要求而具有挑战性。目的:评价浅表放射治疗面部“h区”皮肤癌的疗效和安全性,并探讨其复发的预测因素。方法:回顾性分析2010年至2021年在瑞士苏黎世大学医院接受浅表RT治疗的面部“h区”SC患者。该研究包括基底细胞癌(BCC)、鳞状细胞癌(SCC)和原位SCC (isSCC)、恶性小痣黑色素瘤(LMM)、恶性小痣瘤(LM)和原发性皮肤T/ b细胞淋巴瘤(pcTCL和pcBCL)。结果:我们在382例患者中发现了550个病变。估计5年复发率最低的是SCC(3.2%)、isSCC(1.9%)和BCC(9.7%),而LMM和LM的复发率分别为28.9%和35.0%。总体复发的重要预测因素是不良事件通用术语标准(CTCAE)等级的增加,危险比(HR)为1.9(1.1-3.4),继发性病变的治疗风险比为2.6(1.4-5.1)。结论:在包括面部“h区”在内的高危区域,RT是恶性皮肤肿瘤,特别是NMSC的一种有价值的治疗选择,具有良好的效果和最小的副作用。
{"title":"X-Ray Therapy of Skin Cancer at Critical Facial Sites: Results of a Tertiary Referral Center.","authors":"Sophie Tschopp, Amélie Ciernik, Reinhard Dummer, Laurence Imhof","doi":"10.1159/000548154","DOIUrl":"10.1159/000548154","url":null,"abstract":"<p><strong>Background: </strong>Therapeutic management of skin cancer (SC) in the \"H-area\" of the face is challenging due to the demands of function, cosmesis, and efficacy.</p><p><strong>Objective: </strong>To evaluate the efficacy and safety of superficial radiotherapy (RT) for SC in the \"H-area\" of the face and to identify predictors of recurrence.</p><p><strong>Methods: </strong>Retrospective analysis of patients with SC in the \"H-area\" of the face treated with superficial RT at the University Hospital of Zurich, Switzerland, between 2010 and 2021. The study included cases of basal cell carcinoma (BCC), squamous cell carcinoma (SCC), in situ SCC (isSCC), lentigo maligna melanoma (LMM), lentigo maligna (LM), and primary cutaneous T/B-cell lymphoma.</p><p><strong>Results: </strong>We identified 546 lesions in 382 patients. Estimated relapse rates at 5 years were lowest for SCC (3.2%), isSCC (1.9%), and BCC (9.7%), while LMM and LM showed estimated relapse rates of 28.9% and 35.0%, respectively. Significant predictive factors for overall recurrence were increased Common Terminology Criteria for Adverse Events (CTCAE) grades with a hazard ratio (HR) of 1.9 (1.1-3.4) and the treatment of secondary lesions with an HR of 2.6 (1.4-5.1).</p><p><strong>Conclusion: </strong>RT is a valuable treatment option for malignant skin tumors, especially non-melanoma SC, in high-risk areas, including the facial \"H-area,\" providing favorable results with minimal side effects.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":" ","pages":"499-510"},"PeriodicalIF":2.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12688331/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946327","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Importance of Reader Studies in Dermatology. 皮肤病学读者研究的重要性。
IF 2.7 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-01-01 Epub Date: 2025-08-27 DOI: 10.1159/000548165
Frank Zelun Jing, Alexander Meves
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引用次数: 0
Lebrikizumab Improved Itch Symptoms and Reduced Itch Interference on Sleep over 52 Weeks in Patients with Moderate-to-Severe Atopic Dermatitis in Two Phase 3 Trials. 在两项3期试验中,Lebrikizumab改善了中度至重度特应性皮炎患者52周的瘙痒症状并减少了瘙痒对睡眠的干扰。
IF 2.7 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-01-01 Epub Date: 2025-07-02 DOI: 10.1159/000547142
Gil Yosipovitch, Peter A Lio, David Rosmarin, Franz J Legat, Esther Serra-Baldrich, Jose-Manuel Carrascosa, Laia Bardolet, Heidi Crane, Marta Casillas, Evangeline Pierce, Jinglin Zhong, Hany ElMaraghy, Sonja Ständer

Introduction: Lebrikizumab significantly reduced itch and itch interference on sleep in patients with moderate-to-severe atopic dermatitis (AD) at week 16 in two phase 3 trials. We investigated itch reduction and the efficacy of improving itch interference on sleep in lebrikizumab-treated patients over 52 weeks.

Methods: At week 16 in ADvocate1 and ADvocate2, patients who met protocol-defined response criteria to lebrikizumab 250 mg every 2 weeks (Q2W) were re-randomized 2:2:1 to lebrikizumab Q2W, lebrikizumab 250 mg every 4 weeks (Q4W), or placebo Q2W to week 52; patients who did not achieve protocol-defined response continued open-label lebrikizumab Q2W. The Pruritus Numeric Rating Scale (NRS) evaluated the worst itch intensity over the previous 24 h in daily electronic diaries; the Sleep-Loss Scale measured the interference of itch on sleep over the last night. For week 16 responders, data after systemic rescue medication or discontinuation due to lack of efficacy were imputed with non-responder imputation; data after topical corticosteroid usage and discontinuation due to other reasons were set as missing; all missing data were imputed with multiple imputation. Descriptive statistics using observed data are reported for week 16 by non-responders.

Results: At week 52 among patients who met week-16 protocol-defined response criteria, 73.4% and 71.8% receiving lebrikizumab Q4W and Q2W, respectively, reported ≥3-point improvement in the Pruritus NRS. Mean percent improvement from baseline to week 52 in the Pruritus NRS was 59.9% and 59.6% with lebrikizumab Q4W and Q2W, respectively. For patients who did not achieve a week-16 protocol-defined response, 73.3% achieved ≥3-point improvement on the Pruritus NRS at week 52, with mean percent improvement from baseline to week 52 of 59.2%. At week 52 in responders, ≥1-point improvement in the Sleep-Loss Scale was achieved by 77.9% and 78.9% of patients receiving lebrikizumab Q4W and Q2W, respectively, with a mean percent improvement from baseline to week 52 of 64.4% and 65.9%. For week-16 non-responders, 86.1% of patients achieved ≥1-point improvement in the Sleep-Loss Scale at week 52, with a mean percent improvement of 74.9%.

Conclusion: These findings indicate that lebrikizumab is an effective AD treatment to reduce itch and improve sleep loss due to itch over the long term for both patients who did and did not meet protocol-defined response criteria at week 16.

在两项3期临床试验中,Lebrikizumab在第16周显著减少了中度至重度特应性皮炎(AD)患者的瘙痒和瘙痒干扰睡眠。我们在lebrikizumab治疗患者的52周内研究了瘙痒减少和改善瘙痒干扰对睡眠的影响。方法:在ADvocate1和ADvocate2的第16周,符合方案定义的每2周250mg (Q2W)的lebrikizumab应答标准的患者以2:2:1的比例重新随机分配到lebrikizumab Q2W、lebrikizumab 250mg每4周(Q4W)或安慰剂Q2W至第52周;未达到方案定义反应的患者继续使用开放标签lebrikizumab Q2W。瘙痒数值评定量表(NRS)在每日电子日记中评估过去24小时内最严重的瘙痒强度;睡眠损失量表测量了瘙痒对睡眠的干扰。对于第16周有应答者,系统抢救用药或因缺乏疗效而停药后的数据用无应答归因法进行归因;局部使用皮质类固醇和因其他原因停药后的数据被设置为缺失;对缺失数据进行多次补全。使用观察数据的描述性统计报告了第16周无反应者。结果:在第52周,符合第16周方案定义的缓解标准的患者中,分别有73.4%和71.8%接受lebrikizumab Q4W和Q2W的患者报告瘙痒症NRS改善≥3点。从基线到第52周,lebrikizumab Q4W和Q2W在Pruritus NRS中的平均改善百分比分别为59.9%和59.6%。对于没有达到第16周方案定义的缓解的患者,73.3%在第52周时在瘙痒症NRS上获得了≥3点的改善,从基线到第52周的平均改善百分比为59.2%。在应答者的第52周,接受lebrikizumab Q4W和Q2W治疗的患者中,77.9%和78.9%分别达到了睡眠损失量表≥1点的改善,从基线到第52周的平均改善百分比分别为64.4%和65.9%。对于第16周无反应的患者,86.1%的患者在第52周时睡眠损失量表改善≥1分,平均改善百分比为74.9%。结论:这些研究结果表明,lebrikizumab是一种有效的AD治疗方法,无论是在第16周达到或未达到方案定义的反应标准的患者,都可以长期减少瘙痒和改善因瘙痒引起的睡眠损失。
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引用次数: 0
Cost-Effectiveness of Photodynamic Therapy and 5-Fluorouracil Cream versus Surgical Excision in Treatment of Bowen's Disease: A Trial-Based Economic Evaluation. 光动力疗法和5-氟尿嘧啶乳膏与手术切除治疗鲍温病的成本-效果:一项基于试验的经济评估
IF 2.7 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-01-01 Epub Date: 2025-09-11 DOI: 10.1159/000548431
Shima Ahmady, Charlotte A M van Riel, Nicole W J Kelleners-Smeets, Klara Mosterd, Brigitte A B Essers

Introduction: Given the increasing incidence of Bowen's disease, treatment leads to a substantial economic burden for healthcare services. There are several treatment options for Bowen's disease, of which surgical excision, 5-fluorouracil (5-FU) and methyl aminolevulinate photodynamic therapy (MAL-PDT) are the most commonly used. Recently, results from a randomized controlled non-inferiority trial showed that 5-FU was non-inferior to excision and was associated with a better cosmetic outcome. MAL-PDT was not shown to be non-inferior to excision. Although 5-FU and MAL-PDT were expected to be cheaper than excision, it remains to be determined whether the potential cost savings compensate for the loss of effectiveness. The aim of this study was to determine the most cost-effective treatment for Bowen's disease when comparing surgical excision, MAL-PDT, and 5% 5-FU cream from a healthcare perspective.

Methods: Data were collected alongside a randomized controlled trial with 250 patients in the Netherlands. Valuation of treatment costs was based on documented resource use and Dutch cost prices. A cost-effectiveness analysis was performed from a healthcare perspective. The primary outcome was the decremental cost-effectiveness ratio (DCER), expressed as the cost-savings per additional recurrence or residual Bowen's disease. Bootstrap analysis and sensitivity analysis were performed to address uncertainty. This trial is registered with ClinicalTrials.gov number, NCT03909646.

Results: At 12 months after treatment, the costs for 5-FU cream were significantly lower (EUR 311 [CI: -240 to -378]) and the costs for MAL-PDT were higher (EUR 3 [CI: -74 to 65]) compared to excision. 5-FU cream offers cost savings compared to excision, but is less effective although within the non-inferiority margin of 22%. Our results showed that 5-FU has the highest probability of being cost-effective at willingness to accept threshold values of EUR 2,500 and lower compared to MAL-PDT and surgical excision.

Conclusion: 5-FU cream is a cost-effective treatment at a threshold value of EUR 2,500 and lower when compared to surgical excision and MAL-PDT. Therefore, from a cost-effectiveness point of view, 5-FU is considered the first-choice treatment option for Bowen's disease.

鉴于鲍文氏病的发病率越来越高,治疗导致医疗保健服务的巨大经济负担。鲍文氏病有几种治疗方法,其中手术切除、5-氟尿嘧啶和甲氨基乙酰丙酸光动力疗法(MAL-PDT)是最常用的。最近,一项随机对照非劣效性试验的结果表明,5-氟尿嘧啶不逊于手术切除,并且与更好的美容效果相关。MAL-PDT并没有表现出优于切除的效果。虽然预计5-氟尿嘧啶和MAL-PDT比切除更便宜,但潜在的成本节约是否能弥补有效性的损失仍有待确定。目的比较手术切除、MAL-PDT和5% 5-氟尿嘧啶乳膏治疗鲍文氏病,从医疗保健角度确定哪种治疗方法具有成本效益。方法收集荷兰250例患者的随机对照试验数据。处理费用的估价是根据记录的资源使用和荷兰成本价格。从保健角度进行了成本效益评估。主要结局是减少成本-效果比(DCER),表示为每增加一次复发或残余鲍文病的成本节约。采用Bootstrap分析和灵敏度分析来解决不确定性。该试验已注册ClinicalTrials.gov,注册号为NCT03909646。结果在治疗后12个月,与切除相比,5-氟尿嘧啶乳膏的费用明显较低(- 311欧元(CI: -240 - -378)), MAL-PDT的费用较高(3欧元(CI: -74- 65))。与切除相比,5-氟尿嘧啶乳膏节省了成本,但效果较差,尽管在22%的非劣效性范围内。我们的研究结果表明,与MAL-PDT和手术切除相比,5-氟尿嘧啶在愿意接受2500欧元或更低的阈值时具有最高的成本效益。5-氟尿嘧啶乳膏是一种具有成本效益的治疗方法,阈值为2500欧元,与手术切除和MAL-PDT相比更低。因此,从成本效益的角度来看,5-氟尿嘧啶被认为是鲍文病的首选治疗方案。
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引用次数: 0
Prevalence of Hidradenitis Suppurativa in Saudi Arabia. 沙特阿拉伯化脓性汗腺炎的流行情况。
IF 2.7 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-01-01 Epub Date: 2025-07-07 DOI: 10.1159/000538727
Yousef Binamer, Ola Samman, Anwar Aldabagh, Jwana Boushi, Dorra Bouazzi, Cecilia E Medianfar, Robin Christensen, Gregor B E Jemec

Introduction: Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition. The prevalence of HS is underreported worldwide; moreover, the epidemiological studies about HS in Saudi Arabia are scarce. Therefore, this study was performed to explore the prevalence in Saudi Arabia.

Methods: This study was a part of the Global Hidradenitis Suppurativa Atlas (GHiSA) initiative. This study was a single-center study in tertiary care center in Riyadh, Saudi Arabia. All relevant data were collected after obtaining a written informed consent, and data were analyzed accordingly. The study was conducted between March and May 2023. The participants were healthy adults accompanying a child or adult in internal medicine or pediatrics outpatient clinics. The diagnosis was done clinically by an expert physician.

Results: In total, 688 individuals were included; the estimated prevalence of HS is a minimum of 4.07% within the sample. The utilized questionnaire has a sensitivity of 100% and a specificity of 15%.

Conclusion: The high prevalence of HS in Saudi population necessitates more education to the community and health care providers for early diagnosis and management.

.

化脓性汗腺炎(HS)是一种慢性皮肤炎症。在世界范围内,HS的患病率报告不足;此外,沙特阿拉伯关于HS的流行病学研究很少。因此,本研究旨在探讨沙特阿拉伯的患病率。方法:本研究是全球化脓性汗腺炎地图集(GHiSA)计划的一部分。本研究是在沙特阿拉伯利雅得三级保健中心进行的单中心研究。在获得书面知情同意后收集所有相关数据,并对数据进行分析。这项研究是在2023年3月至5月期间进行的。参与者是在内科或儿科门诊陪同儿童或成人的健康成年人。这个诊断是由一位专家医生在临床上做出的。结果:共纳入688人;估计样本内HS的患病率至少为4.07%。所使用的问卷敏感度为100%,特异度为15%。结论:沙特人群中HS的高患病率需要加强对社区和卫生保健提供者的早期诊断和管理教育。
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引用次数: 0
Questionnaire-Based Global Prevalence of Hidradenitis Suppurativa: A Systematic Review and Meta-Analysis. 基于问卷调查的全球化脓性汗腺炎患病率:系统回顾和荟萃分析。
IF 2.7 3区 医学 Q2 DERMATOLOGY Pub Date : 2025-01-01 Epub Date: 2025-07-07 DOI: 10.1159/000537920
Jawad Ahmad Zahid, Mattias A S Henning, Dorra Bouazzi, Gregor B E Jemec

Background: Hidradenitis suppurativa (HS), a chronic inflammatory skin disease affecting intertriginous areas, presents a recurring and debilitating challenge. Even though recent efforts have been made to estimate the overall HS prevalence, variations in screening modalities and missing data from the Global South warrant further investigation. Understanding the HS prevalence is crucial for treatment approaches and pathogenesis. Thus, we aimed to estimate a global HS prevalence based on studies using homogeneous validated questions.

Methods: This systematic review was prospectively registered on PROSPERO and adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Searches in PubMed, Embase, and CINAHL were performed on August 9, 2023. Original reports assessing the HS prevalence in adults using the following two questions were included: "Do you have recurrent boils of the skin?" and "Have you for the past 6 months had 2 or more boils/abscesses in any of the below locations: in the axilla, in the groin, around your genitals, on the buttocks, several locations i.e., first the buttocks then the axilla, etc.?" A pooled prevalence with 95% confidence interval (CI) was calculated with a random-effects model.

Results: Eight studies qualified for inclusion, of which the prevalence estimate ranged from 0.7% to 6.4%. The meta-analysis encompassing 49,971 participants revealed a global HS prevalence of 2.5% (95% CI, 1.8-3.5%).

Conclusion: This meta-analysis suggests a global HS prevalence of 2.5% using a validated questionnaire. Due to heterogeneity and sparse data from the Global South, this estimate should be interpreted with caution.

.

背景:化脓性汗腺炎(HS)是一种影响三叶间区慢性炎症性皮肤病,是一种复发性和衰弱性的挑战。尽管最近已经做出了努力来估计HS的总体患病率,但筛查方式的差异和全球南方缺失的数据值得进一步调查。了解HS患病率对治疗方法和发病机制至关重要。因此,我们的目的是基于使用同质验证问题的研究来估计全球HS患病率。方法:本系统评价在PROSPERO上前瞻性注册,并遵循系统评价和荟萃分析(PRISMA)指南的首选报告项目。在PubMed, Embase和CINAHL中检索于2023年8月9日进行。使用以下两个问题评估成人HS患病率的原始报告包括:“您是否有复发性皮肤疖子?”和“您在过去6个月内是否在以下任何位置有2个或更多的疖子/脓肿:在腋窝,在腹股沟,在生殖器周围,在臀部,几个位置,即首先是臀部,然后是腋窝等?”采用随机效应模型计算具有95%置信区间(CI)的合并患病率。结果:8项研究符合纳入标准,其中患病率估计范围为0.7%至6.4%。纳入49,971名参与者的荟萃分析显示,全球HS患病率为2.5% (95% CI, 1.8-3.5%)。结论:本荟萃分析表明,使用有效的问卷调查,全球HS患病率为2.5%。由于全球南方的异质性和稀疏数据,应该谨慎解释这一估计。
{"title":"Questionnaire-Based Global Prevalence of Hidradenitis Suppurativa: A Systematic Review and Meta-Analysis.","authors":"Jawad Ahmad Zahid, Mattias A S Henning, Dorra Bouazzi, Gregor B E Jemec","doi":"10.1159/000537920","DOIUrl":"10.1159/000537920","url":null,"abstract":"<p><p><p>Background: Hidradenitis suppurativa (HS), a chronic inflammatory skin disease affecting intertriginous areas, presents a recurring and debilitating challenge. Even though recent efforts have been made to estimate the overall HS prevalence, variations in screening modalities and missing data from the Global South warrant further investigation. Understanding the HS prevalence is crucial for treatment approaches and pathogenesis. Thus, we aimed to estimate a global HS prevalence based on studies using homogeneous validated questions.</p><p><strong>Methods: </strong>This systematic review was prospectively registered on PROSPERO and adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Searches in PubMed, Embase, and CINAHL were performed on August 9, 2023. Original reports assessing the HS prevalence in adults using the following two questions were included: \"Do you have recurrent boils of the skin?\" and \"Have you for the past 6 months had 2 or more boils/abscesses in any of the below locations: in the axilla, in the groin, around your genitals, on the buttocks, several locations i.e., first the buttocks then the axilla, etc.?\" A pooled prevalence with 95% confidence interval (CI) was calculated with a random-effects model.</p><p><strong>Results: </strong>Eight studies qualified for inclusion, of which the prevalence estimate ranged from 0.7% to 6.4%. The meta-analysis encompassing 49,971 participants revealed a global HS prevalence of 2.5% (95% CI, 1.8-3.5%).</p><p><strong>Conclusion: </strong>This meta-analysis suggests a global HS prevalence of 2.5% using a validated questionnaire. Due to heterogeneity and sparse data from the Global South, this estimate should be interpreted with caution. </p>.</p>","PeriodicalId":11185,"journal":{"name":"Dermatology","volume":" ","pages":"149-158"},"PeriodicalIF":2.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12233976/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Dermatology
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