早期类风湿关节炎分类标准的全国多中心临床验证  

Performance of the classification criteria for early rheumatoid arthritis in a multi-center cohort

作　　者：叶华[1] 苏茵[1] 李茹 赵金霞[2] 刘湘源[2] 梅轶芳[3] 张志毅[3] 郭嘉隆[4] 毕黎琦[4] 刘霞[5] 王国春[5] 刘金晶[6] 冷晓梅[6] 顾菲[7] 孙凌云[7] 邹庆华[8] 方勇飞[8] 姜泉[9] 粟占国[1] 

机构地区：[1]北京大学人民医院风湿免疫科,100044 [2]北京大学第三医院风湿免疫科 [3]哈尔滨医科大学第一医院风湿免疫科 [4]吉林大学中日联谊医院风湿免疫科 [5]中日友好医院风湿免疫科 [6]中国医学科学院 北京协和医院风湿免疫科 [7]南京大学医学院附属鼓楼医院风湿免疫科 [8]第三军医大学西南医院风湿免疫科 [9]中国中医科学院北京广安门医院风湿免疫科

出　　处：《中华风湿病学杂志》2014年第12期802-805,共4页Chinese Journal of Rheumatology

基　　金：国家科技支撑计划（2014BA107800）;“重大新药创制”科技重大专项（2012ZX09303019）

摘　　要：目的 多中心验证并比较早期RA （ERA）分类标准与1987年ACR和2010年ACR/EULAR分类标准在病程≤1年的ERA诊断中的敏感性和特异性.方法 按照国际通用的标准验证方法,入选病程≤1年,年龄＞18岁,至少有1个以上部位关节炎的患者,详细记录发病情况,包括关节肿胀部位、持续时间、对称性、晨僵时间、皮下结节以及伴随症状等,检测其血清中抗CCP抗体、RF、ESR以及CRP等指标,并记录关节影像学改变的特点,经2名风湿科专科医师进行临床诊断,未确诊的患者每3个,月随访1次,共随访1年.比较ERA标准和1987年ACR以及2010年ACR/EULAR标准在ERA分类诊断中的敏感性和特异性.组间比较采用X2检验,敏感性和特异性比较采用Mc Nemar检验,阳性预测值比较采用Score检验.结果 ①共入组患者271例,1年随访结束时确诊病例256例,其中RA 120例,非RA136例;未确诊病例15例.②ERA标准的敏感性（76.7％）略高于2010年标准（70.0％）,差异无统计学意义（P=0.115）;但2010年标准（70.0％）和ERA标准（76.7％）的敏感性均明显高于1987年标准（51.7％）,差异有统计学意义（χ^2=11.524,P＜0.01;χ^2=26.471,P＜0.01）.ERA标准、2010年标准和1987年标准的特异性相似,分别为83.8％、83.8％和86.8％.结论 ERA分类标准在ERA诊断中的敏感性稍高于2010年ACR/EULAR分类标准,明显高于1987年ACR分类标准;3个标准在ERA诊断中的特异性相当,但ERA标准更为简单实用,可用于ERA的临床诊断.Objective To evaluate the classification criteria for early rheumatoid arthritis （ERA） in a multi-center cohort,and compare the specificity and sensitivity among ERA criteria,1987 ACR criteria and 2010 ACR/EULAR criteria.Methods Patients who had arthritic complaints with disease duration no more than 1 year,and age more than 18 years were enrolled.The clinical and laboratory parameters were recorded.The patients were diagnosed by 2 experienced rheumatologists based on the clinical and laboratory features.Undiagnosed patients were followed up every 3 months till 1 year.Chi-square test was performed to compare among groups.Mc Nemar test was performed to compare the sensitivity and specifity.Score test were used to test the positive and negative predictive values.Results A total of 271 patients were enrolled in this study.By the end of one year follow-up,120 patients were diagnosed as RA,136 patients were diagnosed to be other diseases,and 15 patients remained unclassified.The sensitivity of ERA criteria （76.7%） was much higher than 1987 ACR criteria （51.7%）,there was significant difference （χ^2=1 1.524,P〈0.01; χ^2=26.471,P〈0.01）,and similar to 2010 ACR/EULAR criteria （70.0%）; while the specificity among the three criteria was similar.Conclusion The diagnostic value of the ERA criteria is better than 1987 ACR criteria,and it is more simple than 2010 ACR/EULAR criteria.The ERA criteria may be applicable to clinical practice for early RA diagnosis.

关 键 词：关节炎 类风湿 早期诊断 多中心研究 

分 类 号：R593.22[医药卫生—内科学]