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  • 文章类型: Journal Article
    目的:“头皮瘙痒对西班牙皮肤科会诊的影响:SCALP-PR试验”的启动是为了解决皮肤科头皮瘙痒这一常见但经常检查不充分的问题。这种情况导致无法控制的刮擦冲动,影响患者的生活质量,并可能导致头皮损伤。本研究旨在探讨患病率,患者简介,潜在的条件,以及在西班牙治疗头皮瘙痒的方法,并评估安全性和有效性,以及非药物治疗的耐受性。
    方法:从2021年到2022年,75名皮肤科医生在一项关于头皮瘙痒的研究中招募了359名患者,Bellvitge大学医院研究伦理委员会批准,巴塞罗那,西班牙。这项基于证据的研究将荟萃分析与观察性研究技术相结合,专注于现实世界的证据,以检查治疗对生活质量(QoL)的影响。利用皮肤病生活质量指数(DLQI)进行QoL评估,该研究评估了该外用产品在15天内的有效性.通过eCRF进行数据收集,并用统计学方法进行分析,以提供对头皮瘙痒管理的可靠见解。
    结果:发现西班牙头皮瘙痒的患病率为6.9%,主要在平均年龄为52.5岁的女性中。确定的主要原因是脂溢性皮炎和病因不明或敏感头皮瘙痒。压力被认为是一个关键因素,皮质类固醇和卫生措施是常见的治疗方法。在15天后,局部产品在超过90%的患者中显示出瘙痒和抓挠的显著减少。皮肤病生活质量也有所改善,87.1%的患者显示DLQI评分增强。该产品因其化妆品特性而广受好评,具有很高的纹理评级,易于应用,和香味。
    结论:所研究的外用产品是安全的,有效,和美观的治疗,改善大多数患者的各种病因的头皮瘙痒。结果强调了皮肤科对患者中心治疗的需求,为临床实践和未来研究提供重要见解。
    OBJECTIVE: The \"Impact of scalp pruritus in dermatological consultations in Spain: The SCALP-PR trial\" was initiated to address the common yet often insufficiently examined issue of scalp pruritus in dermatology. This condition leads to an uncontrollable urge to scratch, affecting the patients\' quality of life and potentially causing scalp damage. This study aimed to explore the prevalence, patient profile, underlying conditios, and therapeutic approaches for scalp pruritus in Spain, and to assess the safety and efficacy profile, as well as the tolerability of a non-pharmacologic treatment.
    METHODS: From 2021 through 2022, 75 dermatologists enrolled a total of 359 patients in a study on scalp pruritus, approved by the Bellvitge University Hospital Research Ethics Committee, Barcelona, Spain. This evidence-based research combined a meta-analysis with observational study techniques focused on real-world evidence to examine the therapeutic impact on quality of life (QoL). Utilizing the Dermatology Life Quality Index (DLQI) for QoL assessments, the study evaluated the effectiveness of the topical product over 15 days. Data collection was conducted via an eCRF and analyzed with statistical methods to provide reliable insights into the management of scalp pruritus.
    RESULTS: The prevalence of scalp pruritus in Spain was found to be 6.9%, predominantly among women with a mean age of 52.5 years. The leading causes identified were seborrheic dermatitis and pruritus of undetermined etiology or sensitive scalp. Stress was noted as a key factor, with corticosteroids and hygienic measures being common therapies. The topical product demonstrated significant reductions in pruritus and scratching in more than 90% of patients after 15 days. Improvements were also seen in dermatological quality of life, with 87.1% of patients showing enhancements in DLQI scores. The product was well-received thanksto its cosmetic properties, with high ratings in texture, ease of application, and fragrance.
    CONCLUSIONS: The topical product studied is a safe, effective, and cosmetically appealing treatment, improving scalp pruritus in various etiologies for most patients. The results highlight the need for patient-center treatments in dermatology, providing important insights for clinical practice and future research.
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  • 文章类型: Observational Study
    背景:化脓性汗腺炎(HS)是一种引起病变的慢性皮肤病,其中发现高水平的白介素(IL)-23和辅助性T细胞17。阿达木单抗仍然是唯一被批准的治疗方法。Guselkumab,一种针对细胞外IL-23的p19蛋白亚基的抗体被批准用于治疗中重度银屑病,但关于其治疗HS疗效的证据有限.
    目的:评估guselkumab在临床实践条件下治疗中重度HS的有效性和安全性。
    方法:在西班牙13家医院进行了一项多中心回顾性观察性研究,包括在同情使用计划(2020年3月至2022年3月)内接受guselkumab治疗的成年HS患者。数据涉及治疗开始时的患者人口统计学和临床特征(基线),患者报告的结果(疼痛数字评定量表[NPRS]和皮肤病生活质量指数[DLQI]),医师评分(国际化脓性汗腺炎严重程度评分系统[IHS4],记录基线和治疗16、24和48周的HS身体总体评分[HS-PGA]和化脓性汗腺炎临床反应[HiSCR])。
    结果:共纳入69例患者。大多数(84.10%)患有严重的HS(HurleyIII),并且已被诊断超过十年(58.80%)。患者接受过多种非生物(平均3.56)或生物(平均1.78)治疗,在接受生物制剂治疗的患者中,近90%曾接受过阿达木单抗治疗.IHS4、HS-PGA、NPRS,从基线到guselkumab治疗48周观察到DLQI评分(均p<0.01)。在16周和24周时,58.33%和56.52%的患者实现了HiSCR,分别。总的来说,16名患者停止治疗,主要是由于无效(n=7)或功效丧失(n=3)。未观察到严重不良事件。
    结论:我们的结果表明,guselkumab可能是对其他生物制剂无反应的严重HS患者的安全有效的治疗选择。
    BACKGROUND: Hidradenitis suppurativa (HS) is a chronic skin condition causing lesions in which high levels of interleukin (IL)-23 and T-helper17 cells are found. Adalimumab remains the only approved treatment. Guselkumab, an antibody targeting the p19 protein subunit of extracellular IL-23, is approved for the treatment of moderate-severe psoriasis, but evidence on its efficacy in treating HS is limited.
    OBJECTIVE: To assess the effectiveness and safety of guselkumab in treating moderate-severe HS under clinical practice conditions.
    METHODS: A multicentre retrospective observational study was carried out in 13 Spanish hospitals including adult HS patients treated with guselkumab within a compassionate use programme (March 2020-March 2022). Data referred to patient demographic and clinical characteristics at treatment initiation (baseline), patient-reported outcomes (Numerical Pain Rating Scale [NPRS] and Dermatology Life Quality Index [DLQI]), physician scores (International Hidradenitis Suppurativa Severity Score System [IHS4], HS Physical Global Score [HS-PGA] and Hidradenitis Suppurativa Clinical Response [HiSCR]) were recorded at baseline and at 16, 24, and 48weeks of treatment.
    RESULTS: A total of 69 patients were included. Most (84.10%) had severe HS (HurleyIII) and had been diagnosed for over ten years (58.80%). The patients had been subjected to multiple non-biological (mean: 3.56) or biological (mean: 1.78) therapies, and almost 90% of those treated with biologics had received adalimumab. A significant decrease in IHS4, HS-PGA, NPRS, and DLQI scores was observed from baseline to 48weeks of guselkumab treatment (all P<.01). HiSCR was achieved in 58.33% and 56.52% of the patients at 16 and 24weeks, respectively. Overall, 16 patients discontinued treatment, mostly due to inefficacy (n=7) or loss of efficacy (n=3). No serious adverse events were observed.
    CONCLUSIONS: Our results indicate that guselkumab may be a safe and effective therapeutic alternative for patients with severe HS that fail to respond to other biologics.
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  • 文章类型: Observational Study
    背景:化脓性汗腺炎(HS)是一种引起病变的慢性皮肤病,其中发现高水平的白介素(IL)-23和辅助性T细胞17。阿达木单抗仍然是唯一被批准的治疗方法。Guselkumab,一种针对细胞外IL-23的p19蛋白亚基的抗体被批准用于治疗中重度银屑病,但关于其治疗HS疗效的证据有限.
    目的:评估guselkumab在临床实践条件下治疗中重度HS的有效性和安全性。
    方法:在西班牙13家医院进行了一项多中心回顾性观察性研究,包括在同情使用计划(2020年3月至2022年3月)内接受guselkumab治疗的成年HS患者。数据涉及治疗开始时的患者人口统计学和临床特征(基线),患者报告的结果(疼痛数字评定量表[NPRS]和皮肤病生活质量指数[DLQI]),医师评分(国际化脓性汗腺炎严重程度评分系统[IHS4],记录基线和治疗16、24和48周的HS身体总体评分[HS-PGA]和化脓性汗腺炎临床反应[HiSCR])。
    结果:共纳入69例患者。大多数(84.10%)患有严重的HS(HurleyIII),并且已被诊断超过十年(58.80%)。患者接受过多种非生物(平均3.56)或生物(平均1.78)治疗,在接受生物制剂治疗的患者中,近90%曾接受过阿达木单抗治疗.IHS4、HS-PGA、NPRS,从基线到guselkumab治疗48周观察到DLQI评分(均p<0.01)。在16周和24周时,58.33%和56.52%的患者实现了HiSCR,分别。总的来说,16名患者停止治疗,主要是由于无效(n=7)或功效丧失(n=3)。未观察到严重不良事件。
    结论:我们的结果表明,guselkumab可能是对其他生物制剂无反应的严重HS患者的安全有效的治疗选择。
    BACKGROUND: Hidradenitis suppurativa (HS) is a chronic skin condition causing lesions in which high levels of interleukin (IL)-23 and T-helper 17 cells are found. Adalimumab remains the only approved treatment. Guselkumab, an antibody targeting the p19 protein subunit of extracellular IL-23, is approved for the treatment of moderate-severe psoriasis, but evidence on its efficacy in treating HS is limited.
    OBJECTIVE: To assess the effectiveness and safety of guselkumab in treating moderate-severe HS under clinical practice conditions.
    METHODS: A multicentre retrospective observational study was carried out in 13 Spanish Hospitals including adult HS patients treated with guselkumab within a compassionate use programme (March 2020-March 2022). Data referred to patient demographic and clinical characteristics at treatment initiation (baseline), patient-reported outcomes (Numerical Pain Rating Scale [NPRS] and Dermatology Life Quality Index [DLQI]), physician scores (International Hidradenitis Suppurativa Severity Score System [IHS4], HS Physical Global Score [HS-PGA] and Hidradenitis Suppurativa Clinical Response [HiSCR]) were recorded at baseline and at 16, 24, and 48 weeks of treatment.
    RESULTS: A total of 69 patients were included. Most (84.10%) had severe HS (Hurley III) and had been diagnosed for over ten years (58.80%). The patients had been subjected to multiple non-biological (mean 3.56) or biological (mean 1.78) therapies, and almost 90% of those treated with biologics had received adalimumab. A significant decrease in IHS4, HS-PGA, NPRS, and DLQI scores was observed from baseline to 48 weeks of guselkumab treatment (all p<0.01). HiSCR was achieved in 58.33% and 56.52% of the patients at 16 and 24 weeks, respectively. Overall, 16 patients discontinued treatment, mostly due to inefficacy (n=7) or loss of efficacy (n=3). No serious adverse events were observed.
    CONCLUSIONS: Our results indicate that guselkumab may be a safe and effective therapeutic alternative for patients with severe HS that fail to respond to other biologics.
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  • 文章类型: Observational Study
    To estimate prevalence of diabetes in outpatient care and to describe its epidemiological characteristics, comorbidities, and related vascular complications.
    Observational cross-sectional study which included all adults affiliated from a private insurance health plan on March 2019, at Hospital Italiano de Buenos Aires, from Argentina.
    The global prevalence of diabetes resulted in 8.5% with 95% CI 8.3-8.6 (12,832 out of a total of 150,725 affiliates). The age stratum with the highest prevalence was the group between 65 and 80 years old with 15.7% (95% CI 15.3-16.1). People with diabetes had a mean age of 70 years (SD 14), 52% were women, and the most frequently associated cardiovascular risk factors were: dyslipidaemia (88%), arterial hypertension (74%) and obesity (55%). In relation to metabolic control, 60% had at least one glycosylated hemoglobin measured in the last year, 70% of which were less than 7%. Almost 80% have LDL measured at least once in the last 2 years, 55% of them had an LDL value equal to or less than 100 mg/dl. The macrovascular complications present in order of frequency were: acute myocardial infarction (11%), cerebrovascular accident (8%) and peripheral vascular disease (4%); while the microvascular complications were found to be diabetic neuropathy (4%) and retinopathy (2%). 7% had diabetic foot, with less than 1% amputations.
    Diabetes represents a prevalent problem, even in elderly patients. This population continues to present a high cardiovascular risk, with little compliance with therapeutic goals.
    Estimar la prevalencia de diabetes en atención ambulatoria y describir sus características epidemiológicas, comorbilidades y complicaciones vasculares relacionadas.
    Corte transversal que incluyó la totalidad de adultos afiliados a la prepaga del Hospital Italiano de Buenos Aires en marzo de 2019, Argentina.
    La prevalencia global de diabetes resultó del 8.5% con intervalo de confianza del 95% (IC95%): 8.3-8.6 (12,832 de un total de 150,725 afiliados). El estrato etario con mayor prevalencia fue el grupo entre 65 y 80 años, con un 15.7% (IC95%: 15.3-16.1). Las personas con diabetes presentaban una media de edad de 70 años (desviación estándar: 14), el 52% eran mujeres, y los factores de riesgo cardiovasculares más frecuentemente asociados fueron: dislipidemia (88%), hipertensión arterial (74%) y obesidad (55%). En relación con el control metabólico, el 60% tenía al menos una hemoglobina glucosilada medida en el último año, siendo el 70% de estas menores al 7%. Casi el 80% tiene medido el colesterol vinculado a lipoproteínas de baja densidad (c-LDL) al menos una vez en los últimos dos años, de ellos el 55% presentaba un valor de c-LDL igual o menor a 100 mg/dl. Las complicaciones macrovasculares presentes en orden de frecuencia fueron: infarto agudo de miocardio (11%), accidente cerebrovascular (8%) y enfermedad vascular periférica (4%); mientras que las complicaciones microvasculares resultaron ser neuropatía diabética (4%) y retinopatía (2%). El 7% tuvo pie diabético, con menos del 1% de amputaciones.
    La diabetes representa un problema prevalente, incluso en pacientes ancianos. Esta población sigue presentando un elevado riesgo cardiovascular, con escaso cumplimiento de objetivos terapéuticos.
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  • 文章类型: Observational Study
    背景:由于治疗选择有限,耐碳青霉烯的革兰氏阴性菌(CRGN)是一种紧迫的公共卫生威胁,其迅速传播和高临床影响和死亡率。然而,尚未调查这些感染的负担和资源使用情况。本研究的目的是了解在实际临床实践条件下与CRGN感染的临床管理相关的资源的使用。
    方法:进行观察性回顾性图表回顾研究。有关患者人口统计的数据,我们从确诊为CRGN感染的ICU住院患者的临床图表中检索了与住院相关的临床管理和资源使用情况.根据患者数量和地理覆盖范围选择了三家参考西班牙医院。对临床管理和资源使用及其成本进行描述性分析,然后按资源类型计算总成本。
    结果:共有130名患者被纳入研究。患者人数较多(n=43;33%)在61至70岁之间。94(72%)患者为男性,115(88%)患有合并症。在ICU住院的CRGN感染患者中使用的资源的平均总费用为每位患者96,878欧元。这些总费用包括84,140欧元的总住院时间,11,021欧元的治疗(558欧元的抗生素;10,463欧元的其他治疗)和1717欧元的诊断测试费用。
    结论:CRGN感染导致医院资源的大量使用,在医院病房或ICU住院的时间是总费用的驱动因素。诊断测试和治疗,包括抗生素,代表资源使用和成本的最低部分(占总成本的13%)。
    Carbapenem-resistant Gram-negative bacteria (CRGN) are an urgent public health threat because of the limited treatment options, its rapid spreading and high clinical impact and mortality rates. However, the burden and the use of resources of these infections have not been investigated. The aim of the current study is to understand the use of resources associated to the clinical management of CRGN infections in real clinical practice conditions.
    An observational retrospective chart review study was performed. Data regarding patient demographics, clinical management and use of resources associated to hospitalization were retrieved from clinical charts of ICU inpatients with a confirmed CRGN infection. Three reference Spanish hospitals were selected according to their patient volume and geographical coverage. Descriptive analyses of the clinical management and the use of resources and its cost were performed and then total costs by type of resource were calculated.
    A total of 130 patients were included in the study. The higher number of patients (n=43; 33%) were between 61 and 70 years old. Ninety-four (72%) patients were male and 115 (88%) suffered from comorbidities. The mean total cost associated to the resources used in patients with CRGN infections hospitalized in ICU was 96,878€ per patient. These total costs included 84,140€ of total hospital stay, 11,021€ of treatments (558€ of antibiotics; 10,463€ of other treatments) and 1717€ costs of diagnostic tests.
    CRGN infection causes a high use of hospital resources, being the length of stay either in hospital wards or ICU the driver of the total costs. Diagnostic tests and treatments, including antibiotics, represent the lowest part of the use of resources and costs (13% of total costs).
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