2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus
2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus
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DOI：
10.1002/art.40930
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发表时间：
2019-09-01
影响因子：
13.3
通讯作者：
Johnson, Sindhu R.
中科院分区：
文献类型：
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作者：
Aringer, Martin;Costenbader, Karen;Johnson, Sindhu R.
目的在欧洲抗风湿病联盟（EULAR）和美国风湿病学会（ACR）的共同支持下，制定系统性红斑狼疮（SLE）的新分类标准。方法该国际倡议分为四个阶段。1)通过文献的系统回顾和元回归，以及通过国际德尔菲练习、早期患者队列和患者调查生成的标准，评估抗核抗体（ANA）作为进入标准。2)通过德尔菲和名义小组技术练习减少标准。3)基于标准绩效和多标准决策分析结果的标准定义和权重。4)在1,001受试者的新衍生队列中细化权重和阈值得分，并在1,270受试者的新验证队列中与先前标准进行比较验证。结果2019年EULAR/ACR SLE分类标准将至少一次ANA阳性作为强制性进入标准；然后是7个临床（体质、血液学、神经精神病学、粘膜皮肤、浆膜、肌肉骨骼、肾脏）和3个免疫（抗磷脂抗体、补体蛋白、sle特异性抗体）结构域的加权标准，加权范围从2到10。累积>= 10分。在验证队列中，新标准的敏感性为96.1%，特异性为93.4%，而ACR 1997标准的敏感性为82.8%，特异性为93.4%，系统性狼疮国际合作诊所2012标准的敏感性为96.7%，特异性为83.7%。结论该分类标准采用严谨的方法，具有良好的敏感性和特异性。使用ANA进入标准、分层聚类和加权标准反映了当前对SLE的思考，并为SLE研究提供了改进的基础。
Objective To develop new classification criteria for systemic lupus erythematosus (SLE) jointly supported by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). Methods This international initiative had four phases. 1) Evaluation of antinuclear antibody (ANA) as an entry criterion through systematic review and meta-regression of the literature and criteria generation through an international Delphi exercise, an early patient cohort, and a patient survey. 2) Criteria reduction by Delphi and nominal group technique exercises. 3) Criteria definition and weighting based on criterion performance and on results of a multi-criteria decision analysis. 4) Refinement of weights and threshold scores in a new derivation cohort of 1,001 subjects and validation compared with previous criteria in a new validation cohort of 1,270 subjects. Results The 2019 EULAR/ACR classification criteria for SLE include positive ANA at least once as obligatory entry criterion; followed by additive weighted criteria grouped in 7 clinical (constitutional, hematologic, neuropsychiatric, mucocutaneous, serosal, musculoskeletal, renal) and 3 immunologic (antiphospholipid antibodies, complement proteins, SLE-specific antibodies) domains, and weighted from 2 to 10. Patients accumulating >= 10 points are classified. In the validation cohort, the new criteria had a sensitivity of 96.1% and specificity of 93.4%, compared with 82.8% sensitivity and 93.4% specificity of the ACR 1997 and 96.7% sensitivity and 83.7% specificity of the Systemic Lupus International Collaborating Clinics 2012 criteria. Conclusion These new classification criteria were developed using rigorous methodology with multidisciplinary and international input, and have excellent sensitivity and specificity. Use of ANA entry criterion, hierarchically clustered, and weighted criteria reflects current thinking about SLE and provides an improved foundation for SLE research.