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Results of a social support programme to provide treatment and improve health related quality of life in refugees and homeless people 为难民和无家可归者提供治疗和改善与健康有关的生活质量的社会支持计划的成果
Pub Date : 2024-05-27 DOI: 10.1002/jvc2.439
Adel Sammain, Marco Borghi, Aldo Morrone

Background

Currently, European and especially Italian healthcare systems are being challenged with providing medical care to an increasing number of refugees but also to the homeless living on the streets, in reception facilities or cohabitation. In 2022, over 200,000 irregular arrivals of migrants to Europe were recorded, coming from mainly African and also Asian countries and frequently via Mediterranean migration routes.

Objectives

This study aims to report the results of a social support programme to provide treatment and improve health-related quality of life (HrQoL) in refugees and homeless people.

Methods

Observational study during the year 2022, including patients with an immigration background visiting the Clinica dell'Istituto di S. Maria e S. Gallicano di Roma, Italy (IRCCS), or being homeless during this observational study.

Results

We have seen 210 patients. In 177 cases (84.3%), a definitive diagnosis is known. Most frequent skin conditions were infectious, allergic or due to secondary inflammation. We also saw rare cutaneous conditions like Madelung disease or Darier disease.

Conclusions

We provided dermatological consultation and treatment to this very vulnerable population, and our experience shows that this social support programme to enable access to dermatological consultation for the poor was able to improve not only the clinical condition but also the HrQoL 4 weeks after consultation and beginning of treatment.

背景 目前,欧洲,尤其是意大利的医疗系统正面临着向越来越多的难民以及流落街头、住在收容所或同居的无家可归者提供医疗服务的挑战。根据记录,2022 年有超过 20 万名非正常移民抵达欧洲,他们主要来自非洲和亚洲国家,经常经由地中海移民路线。 本研究旨在报告一项社会支持计划的成果,该计划旨在为难民和无家可归者提供治疗并改善他们与健康相关的生活质量(HrQoL)。 方法 在2022年期间进行观察研究,包括在意大利罗马圣玛丽亚和圣加里卡诺研究所诊所(IRCCS)就诊的有移民背景的患者,或在观察研究期间无家可归的患者。 结果 我们共接诊了 210 名患者。其中 177 例(84.3%)已确诊。最常见的皮肤病是感染性、过敏性或继发性炎症。我们还发现了马德龙病或达里尔病等罕见的皮肤病。 结论 我们为这一非常弱势的人群提供了皮肤病咨询和治疗,我们的经验表明,这项为穷人提供皮肤病咨询的社会支持计划不仅能够改善临床状况,还能在咨询和开始治疗 4 周后改善 HrQoL。
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引用次数: 0
Dermoscopic clues of dermatitis cruris pustulosa et atrophicans: A distinct folliculitis in dark skin phototypes 脓疱性皮炎和萎缩性皮炎的皮肤镜线索:深色皮肤光型中的一种独特毛囊炎
Pub Date : 2024-05-26 DOI: 10.1002/jvc2.467
Nkechi Anne Enechukwu MBBS, FMCP (Derm), Gabriel Olabiyi Ogun MBBS, FMCP (Pathology)

Dermatitis cruris pustulosa et atrophicans (DCPA) is a chronic folliculitis prevalent in tropical regions, marked by intensely pruritic recurring follicular pustules with cutaneous oedema, subsequently followed by alopecia, and atrophy of the affected areas. It predominantly affects the shin, exhibits frequent relapses and often displays a limited response to therapy. Despite being described initially as the “Nigerian shin disease,” it has been reported from various continents.1-3

Dermoscopy, an evolving diagnostic tool in the dark skin, has demonstrated high diagnostic utility in various forms of folliculitis; however, its application in DCPA remains unexplored, creating a gap in the literature.4 Given that several other forms of folliculitis prevalent in the tropics mimic DCPA, elucidating the distinctive dermoscopic features of DCPA is essential to enhance diagnostic accuracy and differentiate it from mimics.4 We report a case of DCPA in the dark skin highlighting its dermoscopic features.

A 21-year-old female of African descent presented with a 6-year history of recurrent intensely pruritic right shin rashes. They started as papules and vesicles which became scaly, and occasionally, painful. She had atopic dermatitis and a notable habit of using petrolatum-based emollients for dry scaly skin. Examination revealed shiny right shin with sharply demarcated hyperpigmented areas harbouring multiple papules, vesicles, a few pustules. There was evident alopecia over these areas (Figure 1a).

Dermoscopy demonstrated an accentuated honeycomb pigment pattern, absent skin furrows, perifollicular pustules with coarse hairs emerging from their centres, absent pin point white dots (eccrine duct openings), substantial hair follicle depletion, perifollicular red areas, and areas exhibiting erosions. (Figure 1b–d). Posttreatment showed clearance of pustules and erythema. (Figure 1e,f).

Histopathology (40×) (Figure 2a,b) show mainly intense lymphocytic and few plasma cell infiltration around the hair follicles and other adnexial structures. The lymphoplamacytic infiltration extends from the supercial to deep dermis. There is associated perifollicular fibrosis. A diagnosis of DCPA was made.

She was treated with Co-trimoxazole and advised to avoid occlusive skin care products. Two months later, the lesion had improved with symptom resolution. (Figure 1e,f)

DCPA is uniquely localised to the shin, with rare occurrences on the forearms, trunk, and pubic area, exhibiting a preference for areas with terminal hairs.1-3 Recurrent symmetric follicular pustules at the initial phase eventually progress to alopecia and atrophy of the affected area. Although characteristic, diagnosis can be challenging due to its rarity and resemblance to folliculitis of other aetiologies.

Dermoscopy, is potentially valuable for differentiating DCPA fro

脓疱性皮炎和萎缩性皮炎(DCPA)是一种流行于热带地区的慢性毛囊炎,表现为剧烈瘙痒的复发性毛囊性脓疱,伴有皮肤水肿,随后出现脱发和患处萎缩。该病主要影响胫部,经常复发,对治疗的反应有限。1-3 皮肤镜检查是一种不断发展的深色皮肤诊断工具,已在各种形式的毛囊炎中显示出很高的诊断效用;然而,它在 DCPA 中的应用仍未得到探索,造成了文献空白。4 我们报告了一例深色皮肤毛囊炎病例,强调了其皮肤镜下的特征。一名 21 岁的非洲裔女性在 6 年的病史中反复出现强烈的瘙痒性右胫皮疹。这些皮疹最初为丘疹和水泡,后来变成鳞屑,偶尔还会疼痛。她患有特应性皮炎,并有使用凡士林类润肤剂治疗干燥鳞屑皮肤的显著习惯。检查结果显示,她的右小腿发亮,色素沉着区域明显分界,有多个丘疹、水泡和一些脓疱。皮肤镜检查显示:蜂窝状色素沉着,无皮肤沟纹,毛囊周围有脓疱,脓疱中心有粗毛,无针尖状白点(肾上腺皮质导管开口),毛囊大量耗竭,毛囊周围有红色区域和糜烂区域(图 1b-d)。(图 1b-d)。治疗后脓疱和红斑消失。(组织病理学(40×)(图 2a、b)显示,毛囊和其他附属结构周围主要有密集的淋巴细胞和少量浆细胞浸润。淋巴细胞浸润从真皮上层延伸到真皮深层。毛囊周围伴有纤维化。她接受了共三唑治疗,并被建议避免使用闭塞性护肤品。两个月后,皮损有所改善,症状缓解。(图 1e,f)DCPA 唯一的发病部位是胫部,前臂、躯干和阴部也有罕见病例,而且偏爱有末端毛发的部位。皮肤镜检查对区分 DCPA 和其他形式的毛囊炎很有价值。4 毛囊周围脓疱提示毛囊炎,而伴有毛发内生则提示假性毛囊炎。悬钩子征和浆液性小束表示痂皮性毛囊炎。真菌性毛囊炎表现为毛发断裂、之字形、摩尔斯密码和开瓶器状。中央有圆形脓疱,周围有稀疏的点状血管,虽然诊断不太准确,但这表明是细菌性毛囊炎。脱毛尾(从毛囊开口处突出的乳白色或白色胶状毛囊栓)和圆形乳白色或白色栓,周围有红晕,表明是脱毛性毛囊炎。毛囊炎通常表现为毛发丛。4 具体来说,毛囊和毛囊开口处脱落以及毛发铸型的出现(如我们患者所见)更能说明是脱毛性毛囊炎、5 在我们的患者身上看到的夸大或不连续的蜜梳状色素沉着和正常皮肤皱褶的消失是非特异性的发现,可能会在其他深色皮肤的慢性炎症中观察到。6 尽管 DCPA 很罕见,但仍需要进一步的研究,涉及更多的 DCPA 病例样本,以调查这些特征在区分 DCPA 和其他形式的毛囊炎方面的可靠性。Nkechi Anne Enechukwu参与了构思、方法论、撰写-初稿准备、撰写-审阅和编辑以及可视化等工作。Gabriel Olabiyi Ogun参与了构思、撰写-原稿准备、撰写-审阅和编辑、监督、调查和可视化等工作。本手稿中的患者书面知情同意参与研究,并同意将其去标识化、匿名化、汇总的数据及其病例细节(包括照片)用于发表。伦理批准:不适用。
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引用次数: 0
Skin manifestations and human immunodeficiency virus infection in the Tigray region, Ethiopia: Implications for clinical management and epidemiologic surveillance 埃塞俄比亚提格雷地区的皮肤表现和人体免疫缺陷病毒感染:对临床管理和流行病学监测的影响
Pub Date : 2024-05-24 DOI: 10.1002/jvc2.430
Aldo Morrone, Elva Abril, Ilaria Cavallo, Francesca Sivori, Isabella Sperduti, Viviana Lora, Giovanna D'Agosto, Elisabetta Trento, Martina Pontone, Arianna Mastrofrancesco, Abraham Getachew Kelbore, Frehiwot Daba Gutema, Adel Sammain, Ottavio Latini, Enea Gino Di Domenico, Fulvia Pimpinelli

Background

Patients with human immunodeficiency virus (HIV) infection may present a large variety of skin manifestations, often associated with significant morbidity. In turn, dermatological diseases may represent an early sign of HIV infection, particularly in resource-limited settings.

Objectives

This study aimed to assess the spectrum of dermatological diseases and their potential value as clinical proxies for the early detection and management of HIV in a rural region of Ethiopia.

Methods

The study was performed on a population of 67,161 patients with skin diseases attending the Italian Dermatological Center in Mekele, Tigray region, Ethiopia. HIV infection was diagnosed in 1892 individuals (1065 female), all naïve to antiretroviral therapy.

Results

Infectious skin diseases were present in 57.2% of the total HIV population. Among the infectious skin manifestations, dermatophytosis (20.5%), impetigo (5.9%), candidiasis (4.7%) and molluscum contagiosum (4.7%) were significantly more represented in patients with HIV infection (p < 0.001). Regarding the noninfectious manifestations, pruritus and atrophy of the papillae on the tongue were significantly associated with HIV (p < 0.001). Notably, females had a significantly higher incidence of dermatophytosis and seborrheic dermatitis as compared to their male counterparts (p < 0.001), whereas scabies, psoriasis and leishmaniasis were significantly more frequent in males (p < 0.001).

Conclusions

Skin manifestations are common in HIV patients, often reflecting compromised immune status. In addition, Dermatophytosis and pruritus were the most frequently reported manifestations of HIV, thus representing useful clinical proxies to raise the suspicion of an underlying HIV infection. Besides, gender differences in skin manifestations should also be considered in the clinical evaluation.

背景 人类免疫缺陷病毒(HIV)感染患者可能会出现各种各样的皮肤表现,通常与严重的发病率有关。反过来,皮肤病可能是 HIV 感染的早期征兆,尤其是在资源有限的环境中。 目的 本研究旨在评估皮肤病的范围及其作为埃塞俄比亚农村地区 HIV 早期检测和管理的临床代用指标的潜在价值。 方法 研究对象是在埃塞俄比亚提格雷地区 Mekele 的意大利皮肤病中心就诊的 67161 名皮肤病患者。其中 1892 人(1065 名女性)被确诊感染了艾滋病毒,他们都是抗逆转录病毒疗法的新患者。 结果 57.2% 的艾滋病毒感染者患有传染性皮肤病。在感染性皮肤病中,皮癣(20.5%)、脓疱疮(5.9%)、念珠菌病(4.7%)和传染性软疣(4.7%)在艾滋病病毒感染者中的比例明显更高(p < 0.001)。在非感染性表现方面,瘙痒和舌乳头萎缩与艾滋病病毒感染明显相关(p <0.001)。值得注意的是,女性皮肤癣菌病和脂溢性皮炎的发病率明显高于男性(p <0.001),而疥疮、牛皮癣和利什曼病的发病率则明显高于男性(p <0.001)。 结论 皮肤表现在艾滋病毒感染者中很常见,通常反映出免疫状态受到损害。此外,皮肤癣菌病和瘙痒症是最常报告的艾滋病病毒感染表现,因此是怀疑潜在艾滋病病毒感染的有用临床代用指标。此外,在临床评估中还应考虑皮肤表现的性别差异。
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引用次数: 0
The Horn Flap outcome in the nasal tip defect: Evaluation of postoperative scarring through patient and observer scar assessment scale score 角皮瓣治疗鼻尖缺损的效果:通过患者和观察者疤痕评估量表评分评估术后疤痕
Pub Date : 2024-05-22 DOI: 10.1002/jvc2.466
Michele Lanzetti, Fabrizio Rocco Mancuso, Luca Mariano, Filippo Toaiari, Andrea Marino, Camilla Salvini, Giulia Mariotti, Emanuele Maria Cipollini
<p>The closure of nasal defects after oncological excision poses a great challenge, mainly because, as in this site skin is thin and rich of sebaceous glands, local flaps tend to shrink, resulting in unaesthetic trapdoor scarring.<span><sup>1, 2</sup></span> Besides grafts collected from other regions of the head do not effectively resemble skin colour and texture of this specific recipient site. The Horn Flap represents a reliable and versatile flap for reconstruction of the lateral nasal tip<span><sup>3</sup></span> and supratip. Based on a myocutaneous island flap, designed in triangular fashion reminding a rhino horn, it is achieved following a bilevel dissection (Figure 1): from one side to the depth of adipose tissue above the muscle transversalis, while on the opposite side to the depth of nasal cartilage through the muscle. The muscular pedicle, obtained through the two level undermining, provides the flap with great mobility and ensures adequate blood supply, owing to the angular artery and network of vascular anastomosis with the dorsonasal artery. To assess Horn Flap<span><sup>4</sup></span> technique effectiveness in reparation of surgical breach and its cosmetic outcomes, we collected five patients affected by basal cell carcinomas (BCC) of the nasal tip region, mean age 66.2 (SD ± 10.3), who underwent surgical reconstruction through Horn Flap in the Dermatology Surgery Department of Florence, Italy, between January 2022 and December 2022. Mean size of the defect after radicalization measured 17 mm (SD ± 0.3 mm) and all patients were treated in single stage procedure, followed by antibiotic prophylaxis. At 48 h visit flaps were vital and healed with no postoperative complications. After 1 year we performed a follow up visit aimed to scarring evaluation through the <i>Patient and Observer Scar Assessment Scale</i> (POSAS). Although it was originally developed by Draaijers<span><sup>5</sup></span> for burn scars, POSAS has shown high consistency and feasibility even when applied to postsurgical outcomes.<span><sup>6, 7</sup></span> It stands as a multidimensional tool of evaluation, entailing both observer and patient's evaluation.<span><sup>8, 9</sup></span> Every item is evaluated through a 1–10 points scale, where 1 conveys the most optimal result and 10 the worst imaginable. According to that, we submitted POSAS to our patients and to three independent dermosurgeons. The scores collected among clinicians exhibited good rates of coherency: items <i>vascularity, pigmentation, relief</i> and <i>pliability</i> achieved score 1/10 in all five cases, while item <i>thickness</i> received an average score 2.2/10, showing the three doctors shared mild concern about scar roughness. Coherently with healthcarers' point of view, the five patients delivered minimal scores (average 1.1/10) regarding <i>pain, itch, colour</i> and <i>stiffness</i>. Patients expressed slight disappointment regarding item <i>thickness</i> with average score of 1.8/10
Giulia Mariotti:为患者治疗和随访、照片采集、构思和修改做出贡献;主刀医生。埃马努埃莱-玛丽亚-西波利尼(Emanuele Maria Cipollini):作者声明无利益冲突。本手稿中的患者已书面知情同意参与研究,并同意将其去标识化、匿名化的数据和病例细节(包括照片)用于发表。伦理审批不适用。
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引用次数: 0
Occupational skin cancer screening: Results of a cross-sectional study at the city drainage company Munich 职业性皮肤癌筛查:慕尼黑城市排水公司横断面研究结果
Pub Date : 2024-05-21 DOI: 10.1002/jvc2.463
K. E. Mayer, M. Schreier, C. Gross, S. Wasserer, K. Kranen, P. Wustrow, T. Biedermann, A. Zink, O.-D. Persa

Background

Since skin cancer incidence and prevalence are rising steadily, the prevention of skin cancer has gained importance. People with high sun exposure at work are at special risk, and prevention measures by the employer may lower the risk, especially for keratinocyte carcinoma.

Objectives

The aim of the study was to evaluate the results of a large-scale skin cancer screening campaign at the city drainage company Munich where the cohort consisted mainly of outdoor workers.

Methods

In 2023, a skin cancer screening campaign was conducted at the city drainage company Munich. Sun exposure and protection measures of each participant were assessed using a questionnaire. Dermatologists identified clinical signs for sun damage and skin cancer by whole-body skin examination.

Results

A total of 290 participants (72.8% male; mean age 43.7 ± 11.5 years) were enroled. 36.6% showed clinical signs of sun damage correlating with male gender, higher age, and more hours spent outdoors per day. Clinical examination revealed a suspect finding of skin cancer, a preliminary stage, or a lesion requiring clinical control to avoid skin cancer development in 19.3% of participants. Participants with atypical melanocytic lesions were mostly female and showed a high skin cancer awareness. This was concluded from the fewer signs of sun damage, a higher percentage of previous screening participation, and more regular self-examination.

Conclusions

Whole-body examination for skin cancer screening at work is a valuable tool to encourage participation in this preventive measure. It may help identify people at risk either by clinical signs for sun damage or risk exposure which can be assessed with a simple questionnaire. Based on this result, the screening interval may be adopted individually.

由于皮肤癌的发病率和患病率持续上升,预防皮肤癌已变得越来越重要。该研究的目的是评估慕尼黑城市排水公司大规模皮肤癌筛查活动的结果,该公司的人群主要由户外工作者组成。2023 年,慕尼黑城市排水公司开展了一次皮肤癌筛查活动。2023 年,慕尼黑城市排水公司开展了一次皮肤癌筛查活动,通过问卷调查对每位参与者的日晒情况和防护措施进行了评估。共有 290 名参与者(72.8% 为男性;平均年龄为 43.7 ± 11.5 岁)参加了此次活动。36.6%的人有晒伤的临床表现,这与男性性别、年龄较大和每天户外活动时间较长有关。临床检查发现,19.3%的参与者有疑似皮肤癌、初期皮肤癌或需要临床控制以避免发展为皮肤癌的病变。患有非典型黑色素细胞病变的参与者多为女性,且对皮肤癌的认识程度较高。工作场所皮肤癌筛查的全身检查是鼓励参与这一预防措施的重要工具。工作场所皮肤癌筛查的全身检查是一项非常有价值的工具,可以鼓励人们参与这项预防措施。它可以通过日晒损伤的临床表现或风险暴露来帮助识别高危人群,而风险暴露可以通过简单的问卷进行评估。在此基础上,可根据个人情况确定筛查间隔时间。
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引用次数: 0
Effectiveness of secukinumab for overlapping hidradenitis suppurativa and ankylosing spondylitis 赛库单抗对重叠性化脓性扁桃体炎和强直性脊柱炎的疗效
Pub Date : 2024-05-20 DOI: 10.1002/jvc2.458
Mariam AlAfeefi, Meera Aladawi

Hidradenitis suppurativa is a chronic inflammatory disease of the hair follicle that affects the axillary and gluteal regions. Hidradenitis can coincide with other inflammatory diseases, such as ankylosing spondylitis. We present a patient suffering from an overlap of both conditions, who had a rapid improvement with secukinumab.

化脓性扁平湿疹是一种慢性毛囊炎,好发于腋窝和臀部。化脓性扁平湿疹可能与其他炎症并发,如强直性脊柱炎。我们为您介绍一位同时患有这两种疾病的患者,她在使用secukinumab后病情迅速好转。
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引用次数: 0
Determining meaningful thresholds for evaluating treatment efficacy in patients with alopecia areata 确定有意义的阈值,以评估斑秃患者的治疗效果
Pub Date : 2024-05-20 DOI: 10.1002/jvc2.441
Ernest H. Law, Nicole J. Williams, Dane Korver, Randall H. Bender, Debanjali Mitra, Gregor Schaefer, Lauren M. Nelson

Background

The Severity of Alopecia Tool (SALT) is a clinician-reported outcome measure of scalp hair loss in alopecia areata (AA).

Objectives

To characterise the magnitudes of change in SALT scores corresponding to meaningful treatment benefits from the patient's perspective.

Methods

Anchor-based methods for the estimation of meaningful within-patient change thresholds were applied to pooled data from a randomised, double-blind trial of ritlecitinib. Anchors included a patient-reported measure of change in AA severity, the Patient Global Impression of Change (PGI-C) and three items comprising the Patient Satisfaction with Hair Growth (P-Sat) questionnaire. After reviewing Pearson correlations between change-from-baseline SALT scores and each anchor to confirm adequate association, potential thresholds were computed as mean change-from-baseline SALT scores among patients who reported moderate improvement on the PGI-C and/or moderate satisfaction on each of three P-Sat items at week 24.

Results

Six hundred and fifty participants (86% adults, 14% adolescents) had mean (standard deviation) SALT scores of 90.6 (14.3) at baseline, suggesting a sample with primarily severe AA. Correlations between SALT change-from-baseline scores and the patient-reported items supported their use as anchors. Estimates based on patients reporting moderate improvement in AA (n = 102) on the PGI-C and those reporting moderate satisfaction on the P-Sat item related to the amount of hair growth at week 24 (n = 122) were −42.2 (26.1) and −43.1 (26.8), respectively. Supportive estimates based on the remaining P-Sat items were similar in magnitude.

Conclusions

Among patients with severe AA, SALT change-from-baseline scores of 42 or 43 represent meaningful improvements. While the achievement of low SALT scores of ≤10–≤20 have been used to characterise efficacy in clinical trials, the amount of change required to meet this endpoint far exceeds the estimates in this study. The treatment goals of individual patients must be considered when evaluating benefit in both clinical trials and clinical practice.

脱发严重程度工具(SALT)是一种由临床医生报告的衡量斑秃(AA)患者头皮脱发情况的结果。从患者的角度来看,SALT评分的变化幅度与有意义的治疗获益相对应。基于锚点的方法用于估算有意义的患者内部变化阈值,该方法适用于瑞替西替尼随机双盲试验的汇总数据。锚点包括患者报告的AA严重程度变化测量指标--患者全球变化印象(PGI-C)和患者生发满意度(P-Sat)问卷中的三个项目。在审查了 SALT 基线分数变化与每个锚点之间的皮尔逊相关性以确认两者之间存在充分关联后,计算出了潜在的阈值,即在第 24 周时,PGI-C 和/或 P-Sat 三个项目中的每个项目均报告有中度改善的患者的 SALT 基线分数变化平均值。65 名参与者(86% 为成人,14% 为青少年)在基线时的 SALT 分数平均值(标准差)为 90.6(14.3),这表明样本中的 AA 主要为重度 AA。SALT 基线分数变化与患者报告项目之间的相关性支持将其用作锚点。根据患者在 PGI-C 中报告 AA 有中度改善(102 人),以及在第 24 周时在与毛发生长量相关的 P-Sat 项目中报告中度满意(122 人),估计值分别为 -42.2 (26.1) 和 -43.1 (26.8)。在重度 AA 患者中,SALT 与基线相比的变化分数达到 42 或 43 分即为有意义的改善。虽然在临床试验中,≤10-≤20 分的低 SALT 分数被用来描述疗效,但达到这一终点所需的变化量远远超过了本研究的估计值。在临床试验和临床实践中评估疗效时,都必须考虑患者的治疗目标。
{"title":"Determining meaningful thresholds for evaluating treatment efficacy in patients with alopecia areata","authors":"Ernest H. Law,&nbsp;Nicole J. Williams,&nbsp;Dane Korver,&nbsp;Randall H. Bender,&nbsp;Debanjali Mitra,&nbsp;Gregor Schaefer,&nbsp;Lauren M. Nelson","doi":"10.1002/jvc2.441","DOIUrl":"10.1002/jvc2.441","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The Severity of Alopecia Tool (SALT) is a clinician-reported outcome measure of scalp hair loss in alopecia areata (AA).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>To characterise the magnitudes of change in SALT scores corresponding to meaningful treatment benefits from the patient's perspective.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Anchor-based methods for the estimation of meaningful within-patient change thresholds were applied to pooled data from a randomised, double-blind trial of ritlecitinib. Anchors included a patient-reported measure of change in AA severity, the Patient Global Impression of Change (PGI-C) and three items comprising the Patient Satisfaction with Hair Growth (P-Sat) questionnaire. After reviewing Pearson correlations between change-from-baseline SALT scores and each anchor to confirm adequate association, potential thresholds were computed as mean change-from-baseline SALT scores among patients who reported moderate improvement on the PGI-C and/or moderate satisfaction on each of three P-Sat items at week 24.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Six hundred and fifty participants (86% adults, 14% adolescents) had mean (standard deviation) SALT scores of 90.6 (14.3) at baseline, suggesting a sample with primarily severe AA. Correlations between SALT change-from-baseline scores and the patient-reported items supported their use as anchors. Estimates based on patients reporting moderate improvement in AA (<i>n</i> = 102) on the PGI-C and those reporting moderate satisfaction on the P-Sat item related to the amount of hair growth at week 24 (<i>n</i> = 122) were −42.2 (26.1) and −43.1 (26.8), respectively. Supportive estimates based on the remaining P-Sat items were similar in magnitude.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Among patients with severe AA, SALT change-from-baseline scores of 42 or 43 represent meaningful improvements. While the achievement of low SALT scores of ≤10–≤20 have been used to characterise efficacy in clinical trials, the amount of change required to meet this endpoint far exceeds the estimates in this study. The treatment goals of individual patients must be considered when evaluating benefit in both clinical trials and clinical practice.</p>\u0000 </section>\u0000 </div>","PeriodicalId":94325,"journal":{"name":"JEADV clinical practice","volume":"3 4","pages":"1119-1131"},"PeriodicalIF":0.0,"publicationDate":"2024-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jvc2.441","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141120045","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}
引用次数: 0
Underreporting of sleep variables in psoriasis clinical trials 银屑病临床试验中睡眠变量的漏报问题
Pub Date : 2024-05-20 DOI: 10.1002/jvc2.464
Grace Xiong, Nicholas Hua, Ron Vender
<p>Dear Editor,</p><p>The successful management of psoriasis, a chronic skin condition characterised by red, scaly plaques, may depend on consistent, high-quality sleep.<span><sup>1</sup></span> Numerous studies indicate that individuals without healthy sleep routines may experience more severe psoriasis symptoms.<span><sup>2-4</sup></span> Although the exact mechanism between sleep and psoriasis has yet to be elucidated, epidermal immune dysregulation caused by disruptions in sleep patterns is thought to be involved.<span><sup>4</sup></span> Increased numbers of circulating proinflammatory molecules due to poor sleep, coupled with decreased skin healing, further aggravate symptoms.<span><sup>5, 6</sup></span> Furthermore, lack of sleep can heighten anxiety and stress, psychological factors known to cause psoriasis flare-ups.<span><sup>7, 8</sup></span> This necessitates the monitoring of study participants' sleep when developing psoriasis treatments, as both healthy and poor practices may modulate trial results.<span><sup>1, 3</sup></span></p><p>Literature also corroborates this need, as patients who consistently achieve sufficient sleep have lower levels of baseline inflammation, thereby complementing the anti-inflammatory effects of psoriasis medications.<span><sup>2, 3, 9</sup></span> We aim to investigate how sleep is incorporated into the design of recent psoriasis clinical trials and any reporting trends over the past 10 years.</p><p>We searched clinicaltrials.gov for phase 2 and 3 psoriasis clinical trials with start dates between 1 January 2013 and 15 November 2023 using filters: all sexes, all ages, interventional design, with results. Only English language studies were included, yielding 255 trials that were screened for sleep. Psoriatic arthritis was excluded. Twenty-three studies were then extracted by two independent reviewers (G. X. and N. H.) for intervention type, date completed, country, funding, sleep outcome measures, sleep-related results, sleep analysis and incorporation into the inclusion criteria.</p><p>Our results demonstrate that only 9% of psoriasis clinical trials in the past 10 years mentioned sleep, with just 7/23 reporting sleep as an actual study outcome. In these studies, one identified sleep as a primary outcome, and six collected sleep data secondary to measures such as the dermatology life quality index. Psoriasis subtypes included nail (1/23), plaque (9/23) and unspecified (13/23). 82.6% (19/23) of studies investigated systemic therapies, whereas 17.4% examined topicals. Interestingly, no studies for lifestyle interventions included sleep. Secukinumab was the most commonly examined systemic therapy in 36.8% (7/19) of studies. 14/23 studies in the second half of the study period mention sleep, potentially indicating an upwards trend. Only one study (NCT02070965), investigating betamethasone dipropionate cream, incorporated sleep by excluding participants who had abnormal sleep schedules or worked night shifts.
亲爱的编辑,银屑病是一种以红色鳞屑斑块为特征的慢性皮肤病,其成功治疗可能有赖于持续、高质量的睡眠。虽然睡眠与银屑病之间的确切机制尚未阐明,但人们认为睡眠模式紊乱导致的表皮免疫失调与此有 关。4 由于睡眠不足,循环中的促炎分子数量增加,加上皮肤愈合能力下降,会进一步加重症状、8 因此,在开发银屑病治疗方法时,有必要监测研究参与者的睡眠情况,因为健康和不良的睡眠习惯都可能影响试验结果、我们在 clinicaltrials.gov 上搜索了开始日期在 2013 年 1 月 1 日至 2023 年 11 月 15 日之间的 2 期和 3 期银屑病临床试验,筛选条件包括:所有性别、所有年龄、干预设计和结果。仅纳入英语研究,共筛选出 255 项睡眠试验。排除了银屑病关节炎。随后,两名独立审查员(G. X. 和 N. H.)对 23 项研究的干预类型、完成日期、国家、资金、睡眠结果测量、睡眠相关结果、睡眠分析以及纳入标准进行了提取。在这些研究中,有一项研究将睡眠作为主要研究结果,有六项研究在皮肤科生活质量指数等测量指标之外收集睡眠数据。牛皮癣亚型包括指甲型(1/23)、斑块型(9/23)和未指定型(13/23)。82.6%的研究(19/23)调查了系统疗法,而17.4%的研究调查了局部疗法。有趣的是,没有一项关于生活方式干预的研究包括睡眠。在36.8%(7/19)的研究中,塞库单抗是最常见的系统疗法。在研究的后半期,有 14/23 项研究提到了睡眠问题,这可能表明睡眠问题呈上升趋势。只有一项调查二丙酸倍他米松乳膏的研究(NCT02070965)通过排除睡眠时间不正常或上夜班的参与者,将睡眠纳入了研究范围。这一点值得注意,因为外用皮质类固醇试验中睡眠不足的受试者可能会偏离先天性继发性肾上腺功能不全的并发症发生率。临床试验可能只关注生理结果,而不是患者的整体健康,或者没有意识到睡眠与银屑病之间的重要联系。由于银屑病的系统性炎症效应,众所周知银屑病与睡眠障碍(如阻塞性睡眠呼吸暂停)有关。11 在纳入的 11/23 项研究中,睡眠呼吸暂停被有意作为不良事件进行研究,从而证实了这种相关性。2 因此,研究设计有必要明确纳入有效的睡眠质量评估,如埃普沃思嗜睡量表、雅典失眠量表或匹兹堡睡眠质量指数。12 总之,我们鼓励研究人员在设计临床试验时明确纳入睡眠质量评估,并将睡眠障碍作为银屑病的后果和潜在致病或加重因素进行探讨:构思;设计;提取;分析;解释;手稿撰写;通信。Nicholas Hua:构思;设计;提取;解释;手稿撰写。罗恩-文德构思;监督;编辑。所有作者都对这项工作及其智力内容做出了重要贡献。作者声明没有利益冲突。由于这项工作涉及对公开数据的二次分析,因此不需要进行伦理审查。
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引用次数: 0
Verrucous cutaneous lesions on the arm of unusual origin 不同寻常的手臂疣状皮肤病
Pub Date : 2024-05-17 DOI: 10.1002/jvc2.404
Luisa Unterluggauer, Philipp Tschandl, Nicole Harrison, Liliane Borik-Heil

A 55-year-old woman from Afghanistan presented with multiple reddish lesions on the left forearm that appeared 8 weeks prior. Of note, after infiltration of a carpal tunnel syndrome 2 years ago, she had developed recurrent phlegmons on the left forearm. This had led to an ulcer which was covered by a split skin graft 1.5 years ago.

The clinical examination showed several livid-erythematous, partially hyperkeratotic plaques, measuring up to 3 cm, on the dorsal left forearm (Figure 1). These non-painful plaques presented with expression of pus on pressure. In addition, solitary erythematous papules on the skin graft as well as on normal skin of the left forearm could be observed. The rest of the skin was unremarkable. There was no palpable lymphadenopathy and no systemic symptoms like fever were reported. A skin biopsy was made (Figure 2a).

Tuberculosis verrucosa cutis

A skin biopsy showed a pseudoepitheliomatous hyperplasia with a dense dermal superficial lympho-histiocytic inflammatory infiltrate including multinucleated giant cells, suggesting an infectious cause (Figure 2a). Immunohistochemistry confirmed the abundance of CD68+ macrophages (Figure 2b). Acid-fast staining (Ziehl-Neelsen) and a broad-spectrum polymerase chain reaction from the tissue specimen were negative for fungal and bacterial species including Mycobacterium tuberculosis. However, the culture obtained from this skin tissue confirmed the presence of M. tuberculosis complex 6 weeks later. The computed tomography (CT) of the thorax showed pleural consolidations, compatible with former tuberculosis (TB), supported by a positive interferon gamma release assay (IGRA). Further organ involvement could be ruled out via CT and MRI. Sputum specimens were negative for M. tuberculosis. The patient's husband and daughter also had a positive IGRA, but there was no active TB in the patient's social environment.

The patient received a standard tuberculostatic therapy which consisted of an oral combination of rifampicin, ethambutol, pyrazinamide, and isoniazid for 2 months, followed by a treatment with rifampicin and isoniazid for 4 months. The lesions showed remission with just remaining post-inflammatory hyperpigmentation (Figure 3). The IGRA-positive relatives were treated with rifampicin for 4 months.

Extrapulmonary tuberculosis (TB) accounts for approximately 10%–15% of all TB cases and usually manifests as lymphadenitis, pleuritis, or osteoarticular TB.1, 2 Cutaneous forms of TB are very rare, comprising approximately 1%–2% of all TB cases.3 They can present as different clinical phenotypes, for example, ulcers, nodular lesions, abscesses, and verrucous lesions, depending on different factors such as the route of infection, immunity of the infected individual and previous sensitisation to M. tuberculosis.4

Tuberculosis verrucosa cutis (TVC) is a rare

一名来自阿富汗的 55 岁妇女在 8 周前出现左前臂多处淡红色病变。值得注意的是,2 年前腕管综合征浸润后,她的左前臂出现了反复发作的痰。临床检查显示,她的左前臂背侧有多处红斑,部分角化过度,面积达 3 厘米(图 1)。这些斑块无疼痛感,按压时有脓液流出。此外,在植皮处和左前臂正常皮肤上还能观察到单发的红斑丘疹。其余皮肤无异常。未触及淋巴结肿大,也未报告发热等全身症状。皮肤活检显示有假上皮瘤样增生,真皮浅层有密集的淋巴-组织细胞炎症浸润,包括多核巨细胞,提示病因是感染(图 2a)。免疫组化证实了大量的 CD68+ 巨噬细胞(图 2b)。组织标本的耐酸染色(Ziehl-Neelsen)和广谱聚合酶链反应结果显示,真菌和细菌(包括结核分枝杆菌)均呈阴性。然而,6 周后从该皮肤组织中提取的培养物证实了结核分枝杆菌复合体的存在。胸腔计算机断层扫描(CT)显示,胸膜有合并症,与以前的结核病(TB)相符,干扰素γ释放测定(IGRA)呈阳性。通过 CT 和核磁共振成像,可以排除其他器官受累的可能性。痰标本中结核杆菌呈阴性。患者接受了标准的抗结核治疗,包括口服利福平、乙胺丁醇、吡嗪酰胺和异烟肼联合治疗 2 个月,随后又接受了利福平和异烟肼治疗 4 个月。皮损缓解,仅残留炎症后色素沉着(图 3)。肺外结核病(TB)约占所有肺结核病例的 10%-15%,通常表现为淋巴结炎、胸膜炎或骨关节结核。3 它们可表现为不同的临床表型,如溃疡、结节性病变、脓肿和疣状病变,这取决于不同的因素,如感染途径、感染者的免疫力和以前对结核杆菌的敏感性。皮肤疣状结核病(Tuberculosis verrucosa cutis,TVC)是一种罕见(4.3%)的皮肤结核病,多发于免疫力良好的既往致敏者。在多脓疱型结核(即结核性软下疳、瘰疬性皮肤病、人工结核、急性粟粒性结核和转移性脓肿/结核性牙龈肿)中,很容易在组织中检测到结核杆菌,而在较少见的贫脓疱型结核(即:TVC、寻常狼疮)中,则很容易在组织中检测到结核杆菌、4 在全球北方国家,感染非常罕见,通常与特定职业有关,如屠夫、农民和病理学家,导致手部病变。7 在我们的病例中,左前臂上的慢性伤口被认为是病原体的侵入点。本病例说明,皮肤结核虽然是肺外结核的一种罕见形式,在全球北方国家更为罕见,但需要在异常溃疡的鉴别诊断中加以考虑。虽然 PCR 对皮肤结核病的总体敏感性为 73%,但在 TVC 等弱碱性结核病中,敏感性则降至 56%。8 因此,检测弱碱性分枝杆菌感染的诊断程序极具挑战性,必须包括组织样本的显微镜检查、PCR,尤其是培养,因为分枝杆菌的载量可能不同,而且可能低于 PCR 的检测阈值。所有三项检查都应在每位患者身上进行,如果最初结果为阴性,但仍怀疑是皮肤结核,则应重复检查:Luisa Unterluggauer、Liliane Borik-Heil、Philipp Tschandl 和 Nicole Harrison。起草手稿:Luisa Unterluggauer 和 Liliane Borik-Heil。对手稿中的重要思想内容进行严格修改:Liliane Borik-Heil、Philipp Tschandl 和 Nicole Harrison。
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引用次数: 0
Compatibility study of topical 0.25% hypericin (HyBryteTM) application in subjects with mycosis fungoides: Results of the HPN-CTCL-02 study 真菌病患者局部使用 0.25% 金霉素 (HyBryteTM) 的相容性研究:HPN-CTCL-02 研究结果
Pub Date : 2024-05-15 DOI: 10.1002/jvc2.442
Carolina V. Alexander-Savino, Adam Rumage, Christopher Pullion, Richard Straube, Christopher J. Schaber, Elaine S. Gilmore, Brian Poligone

Background

HyBryteTM is a photodynamic therapy of topical hypericin that has recently been shown to be safe and efficacious in early stage cutaneous T-cell lymphoma (CTCL). However, its efficacy, absorption, and effect on heart function parameters in patients who require greater HyBryteTM exposure is unknown.

Objectives

The primary objectives in this study were to assess hypericin blood levels using a validated detection method with a cut-off value of 0.05 ng/mL and to determine if topical HyBryteTM induces any electrocardiogram (EKG) changes during 8 weeks of treatment. A secondary endpoint of this study was to assess the effectiveness of HyBryteTM in this patient population as well as assessing a different additional light device than the one used in the Phase 3 HPN-CTCL-01/fluorescent light activated synthetic hypericin trial also entitled “A phase 3 multicenter randomised placebo-controlled study to determine the efficacy of topical hypericin and light irradiation for the treatment of cutaneous T-cell lymphoma”.

Methods

A confirmatory, prospective, open-label, single-centre, interventional study focused on stage IB and IIA mycosis fungoides with more than 10% of their body surface areas involved was performed.

Results

Hypericin concentration in K2EDTA whole blood samples collected before and after light activation at Weeks 4, 6 and 8 showed an average blood concentration of 0.13 ng/mL and achieved steady state by Week 4. EKGs were examined for clinical changes at each study visit, including changes in QT intervals and correction of heart rates. No significant clinical changes in EKGs were observed.

Conclusions

Hypericin does not appear to be significantly absorbed through the skin nor cause significant cardiac changes overall or prolong the QT interval when applied topically. A larger study is necessary to clearly define these results.

HyBryteTM是一种局部使用金丝桃素的光动力疗法,最近的研究表明它对早期皮肤T细胞淋巴瘤(CTCL)安全有效。本研究的主要目的是使用有效的检测方法(临界值为 0.05 纳克/毫升)评估金丝桃素的血药浓度,并确定外用 HyBryteTM 是否会在 8 周的治疗期间引起心电图(EKG)变化。这项研究的次要终点是评估 HyBryteTM 在这一患者群体中的疗效,以及评估与 HPN-CTCL-01/ 荧光激活合成金丝桃素三期试验中使用的光照装置不同的额外光照装置,该试验也名为 "确定局部金丝桃素和光照治疗皮肤 T 细胞淋巴瘤疗效的三期多中心随机安慰剂对照研究"。在第 4 周、第 6 周和第 8 周光照前后采集的 K2EDTA 全血样本中,金丝桃素的平均血药浓度为 0.13 纳克/毫升,并在第 4 周达到稳定状态。在每次研究考察时,都会检查心电图的临床变化,包括 QT 间期的变化和心率的校正。金丝桃素似乎不会被皮肤明显吸收,也不会引起明显的整体心脏变化或延长局部用药时的 QT 间期。要清楚地界定这些结果,还需要进行更大规模的研究。
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JEADV clinical practice
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