2015 ACR/EULAR痛风分类标准与既往标准诊断价值的比较研究

Performance of the 2015 ACR/EULAR classification criteria compared with other classification criteria for diagnosis of gout in Chinese patients

目的:对比2015年美国风湿病学会(American College of Rheumatology,ACR)及欧洲抗风湿病联盟(European League Against Rheumatism,EULAR)发布的新的痛风分类标准和既往临床常用痛风分类标准在中国患者中的诊断价值,并对比其在不同病程患者中的诊断意义。方法:收集2012年2月至2016年2月因足踝关节炎(除外多关节炎或合并腰痛患者)于北京大学第一医院风湿免疫科就诊疑诊痛风患者的临床资料。排除标准:已行关节腔/软组织结节穿刺明确诊断痛风或焦磷酸盐沉积症的患者,既往已明确诊断为类风湿关节炎、脊柱关节炎、骨关节炎等疾病的患者。所有患者经随访1年、经2名有经验的临床医生最终诊断定义为痛风的判定标准:关节疼痛或肿痛症状自首次发作病程未超过2年者定义为早期痛风,病程2年以上者定义为长病程痛风。2015年ACR/EULAR痛风分类标准又被分为两种情况,一种仅包括临床指标,不包括影像学检查,在此简称"标准临床版(临床参数)";另一种则包括所有临床以及滑液检验、单尿酸盐(monosodium urate,MSU)检验、影像学指标,在此简称"标准完整版(含影像学、MSU检测)"。结果:共284例患者入组,219例诊断为痛风,65例最终诊断为非痛风导致的关节炎。2015年标准完整版(含影像学、MSU检测)的敏感性和特异性分别为88.13%和95.38%。2015年标准完整版(含影像学、MSU检测)、2015年标准临床版(临床参数)、2010年荷兰标准、1977年美国风湿病协会(American Rheumatism Association,ARA)分类标准的曲线下面积(area under the curve,AUC)分别为0.982、0.983、0.963、0.928;在94例早期痛风患者中,各标准的AUC分别为0.973、0.968、0.916、0.910;在长病程痛风患者中,各标准的AUC分别为0.987、0.991、0.982、0.936。以1977年ARA分类标准为参考标准,在病程≤2年的痛风患者中,2015年标准完整版(含影像学、MSU检测)、2015年标准临床版(临床参数)、2010年荷兰标准诊断敏感性的比值比(odd ratio,OR)分别为1.562(1.003~2.435)、1.500(1.001~2.346)和1.812(1.177~2.791),在长病程痛风患者中,OR值分别为1.702(1.300~2.229)、1.607(1.224~2.110)、1.821(1.396~2.377)。结论:在中国人群中,2015年ACR/EULAR痛风分类标准对不同病程痛风患者的诊断均优于1977年ARA分类标准,具有较高的敏感性和特异性,因此在临床上值得推广。

Objective： To evaluate the ability of 2015 American College of Rheumatology/European League Against Rheumatism（ ACR/EULAR） classification criteria to diagnose gout compared with the widely used 1977 American Rheumatism Association（ ARA） criteria and other criteria in clinical practice in Chinese patients,and to compare the sensitivity and specificity of different classification criteria for gout in early and established diseases. Methods： The patients who had ankle arthritis and visited the Department of Rheumatology and Clinical Immunology,Peking University First Hospital between February2012 and February 2016 were screened. The patients who had been already diagnosed with gout or pyrophosphate deposition disease through arthrocentesis or tissue aspiration and those who had been diagnosed with rheumatoid arthritis,spondyloarthritis,and osteoarthritis were excluded. The patients were diagnosed by two experienced rheumatologists and all of them were followed up for at least one year. Early disease was defined as symptom onset of no more than 2 years; established disease was defined as symptom duration of more than 2 years. The 2015 ACR classification criteria were divided into clinical form with clinical parameters included and complete form with not only clinical parameters but also synovial fluids tests,imaging findings and monosodium urate（ MSU） included. The two forms above were short for ＂clinical form（ incorporating clinical parameters） ＂and ＂complete form（ incorporating imaging and MSU data） ＂respectively. Results： In this study,284 patients suffering from ankle arthritis were included in the study,219 of them were classified as gout and 65 of them had alternative diagnoses. The sensitivity and specificity of 2015 ACR complete form（ incorporating imaging and MSU data） for diagnosing gout were 88. 13% and 95. 38%,respectively. The area under the curves（ AUC） of 2015 ACR ＂complete form（ incorporating imaging and MSU data） ＂,2015 ACR ＂clinical form（ incorporating clinical parameters） ＂,2010 Netherlands criteria and 1977 ARA criteria were 0. 982,0. 983,0. 963,and 0. 928,respectively. For the 94 early gout patients,the AUC of the above criteria were 0. 973,0. 968,0. 916,and 0. 910,respectively. For the established gout patients,the AUC were 0. 987,0. 991,0. 982,and0. 936,respectively. For the patients with disease duration within two years,the odd ratio（ OR） for sensitivity of 2015 ACR ＂complete form（ incorporating imaging and MSU data） ＂,2015 ACR ＂clinical form（ incorporating clinical parameters） ＂,2010 Netherlands criteria and 1977 ARA criteria were 1. 562（ 1. 003-2. 435）,1. 500（ 1. 001-2. 346）,and 1. 812（ 1. 177-2. 791）,nevertheless,for the patients with established gout,the OR were 1. 702（ 1. 300-2. 229）,1. 607（ 1. 224-2. 110）,and 1. 821（ 1. 396-2. 377）,respectively. Conclusion： The 2015 ACR/EULAR criteria are more accurate in gout diagnosis compared with the 1977 ARA criteria by elevating the sensitivity and specificity,in respective of the disease duration. The 2015 ACR/EULAR criteria may serve as new diagnostic tools in daily clinical practice in Chinese patients.