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皮肤病生活质量指数在银屑病生物制剂临床试验中的应用。

Application of the dermatology life quality index in clinical trials of biologics for psoriasis.

机构信息

Department of Dermatology and Wound Healing, Institute of Immunity and Infection, Cardiff University School of Medicine, Heath Park, Cardiff, CF14 4XN, UK.

出版信息

Chin J Integr Med. 2012 Mar;18(3):179-85. doi: 10.1007/s11655-012-1007-0. Epub 2012 Apr 2.

Abstract

The significance of patient-reported outcomes (PROs) is increasingly being acknowledged and quality of life (QOL) has become an integral element of the assessment of overall burden of disease. Psoriasis has been known for its major impact on patients' QOL and various generic, dermatology-specific and psoriasis-specific self-administered psychometric instruments have been used over the years to assess the QOL of psoriasis patients. However, the Dermatology Life Quality Index (DLQI) is the most widely used QOL measure among these measures in psoriasis-related clinical trials. A number of topical and systemic treatments have been used in the management of psoriasis and lately biologics have emerged as a new and promising treatment modality for difficult-to-treat psoriasis. The evidence on the efficacy of these agents has been growing dramatically with QOL being used as one of the primary outcome measures in many clinical trials. The aim of this paper is to give an overview of the use of the DLQI as an outcome measure for assessing the QOL impact of biologics on psoriasis patients. Furthermore, the efficacy of five commonly used biologics has been compared in terms of their ability to improve the QOL assessed by the DLQI. This review has revealed that there is a variation in the efficacy of various biologics in terms of QOL improvement with the mean reduction in the DLQI scores being highest for ustekinumab 90 mg (mean DLQI score reduction=9.5), followed by infliximab (8.5), etanercept 50 mg, twice a week (7.7), adalimumab (6.3), and alefacept (4.0).

摘要

患者报告结局(PROs)的重要性日益得到认可,生活质量(QOL)已成为评估疾病总体负担的一个组成部分。银屑病对患者的 QOL 有重大影响,多年来,各种通用的、皮肤科特有的和银屑病特有的自我管理心理计量学工具已被用于评估银屑病患者的 QOL。然而,在这些与银屑病相关的临床试验中,皮肤病生活质量指数(DLQI)是使用最广泛的 QOL 测量方法。许多局部和系统治疗方法已被用于银屑病的治疗,最近生物制剂作为一种新的、有前途的治疗方法出现,为难治性银屑病提供了新的治疗选择。这些药物的疗效证据呈显著增长趋势,QOL 已成为许多临床试验中的主要终点之一。本文旨在概述 DLQI 作为一种评估生物制剂对银屑病患者 QOL 影响的结局测量方法的应用。此外,还比较了五种常用生物制剂在改善 DLQI 评估的 QOL 方面的疗效。这项综述表明,在 QOL 改善方面,各种生物制剂的疗效存在差异,其中乌司奴单抗 90mg 的平均 DLQI 评分降低幅度最大(平均 DLQI 评分降低 9.5),其次是英夫利昔单抗(8.5)、依那西普 50mg,每周两次(7.7)、阿达木单抗(6.3)和阿法赛普(4.0)。

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