European multicentre study to define disease activity criteria for systemic sclerosis.: II.: Identification of disease activity variables and development of preliminary activity indexes
European multicentre study to define disease activity criteria for systemic sclerosis.: II.: Identification of disease activity variables and development of preliminary activity indexes
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DOI：
10.1136/ard.60.6.592
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发表时间：
2001-06-01
影响因子：
27.4
通讯作者：
Vlachoyiannopoulos, PJ
中科院分区：
文献类型：
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作者：
Valentini, G;Della Rossa, A;Vlachoyiannopoulos, PJ
系统性硬化症（SSc），是有效的，可靠的，易于使用的疾病活动的标准，从19个欧洲中心的研究人员完成了一个标准化的临床图表连续SSc患者的数量。三名方案管理成员盲法评价每张图表，并在0-10的半定量量表上分配疾病活动评分。此外，其中两个对疾病活动性（“非活动性至中度活动性”或“活动性至非常活动性”疾病）进行了盲态定性评价。这两种评价都被认为是可靠的。最终的疾病活动性评分和疾病活动性的定性评价是通过对每例患者的共识达成的;前者代表了后续分析的金标准。图表中的各个项目之间的相关性和这个金标准进行了analysed.Results-A共290例SSc患者（117弥漫性SSc（dSSc）和173有限SSc（lSSc））参加了这项研究。的项目使用在多元回归上发现与金标准相关的Δ因子（即，根据患者报告的恶化）来构建疾病活动性的三个单独的10点指数：（4.0），Delta -皮肤（3.0），三角血管（2.0）和Delta -关节/肌肉（1.0）dSSc患者;（B）三角形皮肤（2.5），红细胞沉降率（ESR）>30 mm/1st h（2.5），Delta -心肺（1.5），Delta -血管（1.0）、关节炎（1.0），低补体血症（1.0）和硬肿症（0.5）为lSSc;（c）Delta -心肺（2.0），Delta -皮肤（2.0），ESR >30 mm/1st h（1.5），皮肤总评分>20（1.0），低补体血症（1.0），硬肿症（0.5），手指坏死（0.5），三角血管（0.5），关节炎（0.5），TLCO
Objective-To develop criteria for disease activity in systemic sclerosis (SSc) that are valid, reliable, and easy to use.Methods-Investigators from 19 European centres completed a standardised clinical chart for a consecutive number of patients with SSc. Three protocol management members blindly evaluated each chart and assigned a disease activity score on a semiquantitative scale of 0-10. Two of them, in addition, gave a blinded, qualitative evaluation of disease activity ("inactive to moderately active" or "active to very active" disease). Both these evaluations were found to be reliable. A final disease activity score and qualitative evaluation of disease activity were arrived at by consensus for each patient; the former represented the gold standard for subsequent analyses. The correlations between individual items in the chart and this gold standard were then analysed.Results-A total of 290 patients with SSc (117 with diffuse SSc (dSSc) and 173 with limited SSc (lSSc)) were enrolled in the study. The items (including Delta -factors-that is, worsening according to the patient report) that were found to correlate with the gold standard on multiple regression were used to construct three separate 10-point indices of disease activity: (a) Delta -cardiopulmonary (4.0), Delta -skin (3.0), Delta -vascular (2.0), and Delta -articular/muscular (1.0) for patients with dSSc; (b) Delta -skin (2.5), erythrocyte sedimentation rate (ESR) >30 mm/1st h (2.5), Delta -cardiopulmonary (1.5), Delta -vascular (1.0), arthritis (1.0), hypocomplementaemia (1.0), and scleredema (0.5) for lSSc; (c) Delta -cardiopulmonary (2.0), Delta -skin (2.0), ESR >30 mm/1st h (1.5), total skin score >20 (1.0), hypocomplementaemia (1.0), scleredema (0.5), digital necrosis (0.5), Delta -vascular (0.5), arthritis (0.5), TLCO