Department of Internal Medicine, Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan.
Rheumatology (Oxford). 2011 Jul;50(7):1268-74. doi: 10.1093/rheumatology/keq442. Epub 2011 Feb 3.
To validate the sensitivity and specificity of the 2010 RA classification criteria.
A total of 313 undiagnosed subjects, who first visited Keio University Hospital with joint symptoms, including arthralgia, joint swelling and morning stiffness, without any previous treatment except for NSAIDs, were included in the present study. A clinical diagnosis of RA was made by rheumatologists, and the gold standard diagnosis of RA was defined as an indication for instituting DMARDs for RA.
Seventy-six subjects were diagnosed as gold standard RA. Among these, 8 did not have any swollen joints, 50 were classified as definite RA under the 2010 criteria and the other 18 as not having RA. Eighty-two subjects were eligible for the 2010 criteria, and the sensitivity and specificity under the 2010 criteria were 73.5 and 71.4%, respectively, compared with 47.1 and 92.9% under the 1987 criteria. But the sensitivity of the 2010 criteria decreased to 15.8% when both RF and anti-CCP were negative. According to the result of a receiver-operated characteristic (ROC) curve of the scoring system, if swollen joints and differential diagnosis are not accurately detected, it would be better to use a score of 5 as the cut-off level to detect RA.
The 2010 classification criteria have a high sensitivity and have been verified to be useful for distinguishing RA at an early stage.
验证 2010 年 RA 分类标准的灵敏度和特异性。
本研究共纳入 313 例未经诊断的患者,这些患者首次因关节痛、关节肿胀和晨僵等关节症状就诊于庆应义塾大学医院,且除 NSAIDs 外无任何既往治疗。RA 由风湿病学家进行临床诊断,RA 的金标准诊断定义为需要开始使用 DMARDs 治疗的情况。
76 例患者被诊断为金标准 RA。其中,8 例患者无任何肿胀关节,50 例患者根据 2010 年标准被分类为明确 RA,18 例患者被分类为无 RA。82 例患者符合 2010 年标准,2010 年标准的灵敏度和特异性分别为 73.5%和 71.4%,而 1987 年标准的灵敏度和特异性分别为 47.1%和 92.9%。但当 RF 和抗-CCP 均为阴性时,2010 年标准的灵敏度降至 15.8%。根据评分系统的受试者工作特征(ROC)曲线结果,如果肿胀关节和鉴别诊断不能准确检测,使用 5 分作为截断值来检测 RA 可能更好。
2010 年分类标准具有较高的灵敏度,已被验证可用于早期鉴别 RA。