Development and validation of response criteria in rheumatoid arthritis: steps towards an international consensus on prognostic markers.
Development and validation of response criteria in rheumatoid arthritis: steps towards an international consensus on prognostic markers.
复制标题
类风湿关节炎反应标准的制定和验证：迈向预后标志物国际共识的步骤。
DOI：
--
复制
发表时间：
1996
期刊：
影响因子：
--
通讯作者：
L. van de Putte
中科院分区：
文献类型：
--
作者：
P. van Riel;A. van Gestel;L. van de Putte
类风湿性关节炎（RA）的病程是高度可变的，从轻度自限性到非常侵袭性的形式。为了跟踪和预测个体患者的病程，已经考虑了几种公认的和提出的预后标志物，包括疾病活动的标志物。然而，没有疾病活动性的个体标记物显示出令人满意的特异性和灵敏度。因此，需要结合几个变量的疾病活动指数。基于疾病活动性评分（DAS）的反应标准是在一项对227例近期发作的RA患者的开放性研究中制定的。缓解定义为较基线的显著变化和达到的疾病活动水平的组合。良好反应定义为DAS显著降低（> 1.2）和疾病活动水平低（≤ 2.4）。无应答定义为降低≤ 0.6，或降低> 0.6且≤ 1.2，达到DAS > 3.7。任何其他评分均视为中度缓解。这些反应标准被采纳为EULAR反应标准，并与WHO/ILAR和ACR反应标准一起在一项48周的双盲试验中进行了验证，该试验在60例患者中比较了羟氯喹和柳氮磺胺吡啶。根据放射学损伤（结构效度）和功能障碍（标准效度）评价反应;还评估了辨别能力。EULAR反应标准显示与X线进展和功能障碍显著相关，并区分柳氮磺胺吡啶和羟氯喹。ACR和WHO/ILAR反应标准表现较差，仅显示出良好的标准效度。几个小组正在研究早期RA的预后，并同意合作测试DAS和其他预后标志物，以便在关节损伤发生之前更好地识别严重的进行性RA。
The course of rheumatoid arthritis (RA) is highly variable, ranging from a mild self-limiting to a very aggressive form. To follow and predict the course of the disease in an individual patient, several recognized and proposed prognostic markers, including markers for disease activity, have been considered. However, no individual marker for disease activity has shown satisfactory specificity and sensitivity. Thus an index of disease activity combining several variables is needed. Response criteria based on the Disease Activity Score (DAS) were developed in an open study of 227 patients with RA of recent onset. Response was defined as a combination of a significant change from baseline and the level of disease activity attained. Good response was defined as a significant decrease in DAS (> 1.2) and a low level of disease activity ( < or = 2.4). Non-response was defined as a decrease < or = 0.6, or a decrease > 0.6 and < or = 1.2 with an attained DAS > 3.7. Any other scores were regarded as moderate responses. These response criteria were adopted as the EULAR response criteria and were validated, together with the WHO/ILAR and ACR response criteria, in a 48 week, double-blind trial comparing hydroxychloroquine and sulphasalazine in 60 patients. Response was evaluated against radiographic damage (construct validity) and functional disability (criterion validity); discriminating capacity was also assessed. EULAR response criteria showed significant association with X-ray progression and functional disability, and differentiated between sulphasalazine and hydroxychloroquine. ACR and WHO/ILAR response criteria performed less well, only showing good criterion validity. Several groups are working on the prognosis of early RA and have agreed to collaborate to test DAS and other prognostic markers to better recognize severe, progressive RA, before joint damage takes place.