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皮肌炎临床结局评估工具——皮肤疾病面积和严重程度指数(CDASI)的有效性和实用性:全面综述。

The validity and utility of the Cutaneous Disease Area and Severity Index (CDASI) as a clinical outcome instrument in dermatomyositis: A comprehensive review.

机构信息

Corporal Michael J. Crescenz VAMC, Philadelphia, PA; Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Suite 1-330A, 3400 Civic Center Boulevard, Philadelphia, PA 19104, USA.

Corporal Michael J. Crescenz VAMC, Philadelphia, PA; Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Suite 1-330A, 3400 Civic Center Boulevard, Philadelphia, PA 19104, USA.

出版信息

Semin Arthritis Rheum. 2020 Jun;50(3):458-462. doi: 10.1016/j.semarthrit.2020.01.002. Epub 2020 Jan 11.

DOI:10.1016/j.semarthrit.2020.01.002
PMID:32057402
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7434515/
Abstract

INTRODUCTION

Validated outcome measures are paramount in the assessment of disease progression and evaluation of new therapeutics in clinical trials. Dermatomyositis (DM) is an autoimmune disease that is frequently refractory to current therapies and warrants the development of new treatments. The Cutaneous Disease Area and Severity Index (CDASI) was developed in 2008 in response to a need for a reliable, validated measure of skin disease activity and damage for use in clinical trials and longitudinal monitoring of disease progression.

METHODS

The literature was searched for all studies validating and utilizing the CDASI between 2008 and October 2018 using searches in PubMed. Studies pertaining to validation of the CDASI, correlation with quality of life, use in the evaluation of current therapies and ongoing trials, as well as relationships to biomarkers were included in this review.

RESULTS

The CDASI was found to have intra- and inter-rater reliability, validity, reproducibility, sensitivity to clinical changes, and ease of use. It has been shown to correlate with quality of life as measured by the Skindex-29 outcome measure. The CDASI activity score has additionally been shown to correlate significantly with IFN-β, a key cytokine in DM pathogenesis.

CONCLUSION

The CDASI is a validated measure of dermatomyositis disease and has been shown to be an effective outcome instrument in clinical trials.

摘要

简介

在评估疾病进展和临床试验中评估新疗法时,经过验证的疗效指标至关重要。皮肌炎(DM)是一种自身免疫性疾病,目前的治疗方法常常效果不佳,因此需要开发新的治疗方法。皮肤疾病面积和严重程度指数(CDASI)于 2008 年开发,以满足在临床试验和疾病进展的纵向监测中使用可靠、经过验证的皮肤疾病活动和损伤衡量标准的需求。

方法

使用 PubMed 搜索,检索了 2008 年至 2018 年 10 月期间验证和使用 CDASI 的所有研究。本综述纳入了与 CDASI 验证、与生活质量的相关性、用于评估现有疗法和正在进行的试验、以及与生物标志物的关系相关的研究。

结果

CDASI 具有内部和外部评分者可靠性、有效性、可重复性、对临床变化的敏感性以及使用方便性。它已被证明与 Skindex-29 生活质量衡量标准相关。此外,CDASI 活动评分与 IFN-β显著相关,IFN-β 是 DM 发病机制中的关键细胞因子。

结论

CDASI 是一种经过验证的皮肌炎疾病衡量标准,已被证明是临床试验中的有效疗效指标。

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Evaluating important change in cutaneous disease activity as an efficacy measure for clinical trials in dermatomyositis.评估皮肌炎临床试验中皮肤疾病活动的重要变化作为疗效指标。
Br J Dermatol. 2020 Apr;182(4):949-954. doi: 10.1111/bjd.18223. Epub 2019 Sep 8.
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Examining cutaneous disease activity as an outcome measure for clinical trials in dermatomyositis.将皮肤疾病活动度作为皮肌炎临床试验的一项结局指标进行研究。
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Cutaneous dermatomyositis disease course followed over time using the Cutaneous Dermatomyositis Disease Area and Severity Index.根据皮肤肌炎疾病面积和严重程度指数,对皮肤肌炎疾病随时间推移的病程进行跟踪。
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