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中国循证儿科杂志

中国循证儿科杂志 ›› 2025, Vol. 20 ›› Issue (1): 27-35.DOI: 10.3969/j.issn.1673-5501.2025.01.004

• 论著 • 上一篇    下一篇

系统性红斑狼疮分类标准在成人和儿童队列中诊断准确性研究的Meta分析

鲁璇,沈田,张育迪,李永珍,曹艳,帅兰军,李晓燕,王英,吴小川   

  1. 中南大学湘雅二医院儿科 长沙，410011


  • 收稿日期:2024-12-20 修回日期:2025-02-25 出版日期:2025-02-25 发布日期:2025-02-25
  • 通讯作者: 吴小川

A meta-analysis of the diagnostic accuracy of systemic lupus erythematosus classification criteria in adult and pediatric cohorts

LU Xuan, SHEN Tian, ZHANG Yudi,LI Yongzhen, CAO Yan,SHUAI Lanjun,  LI Xiaoyan, WANG Ying, WU Xiaochuan   

  1. Department of Pediatrics, Second Xiangya Hospital, Central South University, Changsha 410011, China
  • Received:2024-12-20 Revised:2025-02-25 Online:2025-02-25 Published:2025-02-25
  • Contact: WU Xiaochuan

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摘要： 背景：系统性红斑狼疮（SLE）的1997年美国风湿病学会（ACR）标准（简称1997-ACR）、2012年SLE临床国际协作组（SLICC）标准（简称2012-SLICC）和2019年欧洲抗风湿病联盟/美国风湿病学会（EULAR/ACR）标准（简称2019-EULAR/ACR）被广泛用于成人和儿童SLE诊断，但其最初的制定仅基于成人队列，在儿童SLE中的诊断价值尚需进一步验证。 目的： 评估3个标准在成人及儿童SLE中的诊断效能。 设计：Meta分析。 方法：：检索 PubMed、EMBASE、Cochrane 图书馆、中国知网、万方数据库和中国生物医学数据库，根据预先制定的纳入排除标准筛选文献，对比3个标准的敏感度、特异度及受试者工作特征曲线下面积（AUC）并分析异质性来源，采用GRADE证据等级评价。 主要结局指标：3个标准诊断儿童SLE的诊断效能。 结果：本文纳入36项研究中，成人SLE 22项、儿童SLE 13项、成人和儿童SLE 1项。1997-ACR应用在成人SLE 和儿童SLE分别为23项和13项，2012-SLICC应用在成人SLE 和儿童SLE分别为22项和13项，2019-EULAR/ACR应用在成人SLE 和儿童SLE分别为17项和10项。除2012-SLICC成人SLE和儿童SLE特异度和AUC，在3个标准诊断准确性和AUC结果：差异均无统计学意义。儿童SLE:1997-ACR每10万人中，真阳SLE 5（4~5）人，假阳SLE 1（1~2）人；2012-SLICC及 2019-EULAR/ACR每10万人中，真阳SLE 6（6~6）人，假阳SLE 0（0~0）人；成人SLE基于3个标准的Meta分析依据GRADE对证据体评价降2级，为低质量证据，儿童SLE基于3个标准的Meta分析依据GRADE对证据体评价局限性降1级，为中等质量证据。 结论：在儿童和成人SLE中，相较1997-ACR，2012-SLICC和2019-EULAR/ACR诊断效能更优且诊断效能相同；儿童人SLE中2012-SLICC和2019-EULAR/ACR误诊率为0。

关键词: 系统性红斑狼疮, 分类标准, 儿童, 诊断价值, 敏感性, 特异性, Meta分析

Abstract: Background：The 1997 American College of Rheumatology (ACR) criteria, the 2012 Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria, and the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria are widely used for diagnosing systemic lupus erythematosus (SLE) in both adults and children. However, these criteria were initially developed based on adult cohorts, and their diagnostic value in pediatric SLE requires further validation. Objective：To evaluate the diagnostic accuracy of the three classification criteria in adult and pediatric SLE. Design：Meta-analysis. Methods：A literature search was conducted in PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang, and China Biomedical Database. Studies were selected according to predefined inclusion and exclusion criteria. Sensitivity, specificity, and the area under the curve (AUC) of the three classification criteria were compared. Heterogeneity sources were analyzed. GRADE approach was used to evaluate the certainty of evidence. Main outcome measures：Sensitivity and specificity of SLE classification criteria in pediatric cohorts. Results：Thirty-six studies were included, with 22 on adult SLE, 13 on pediatric SLE, and 1 on both. The 1997 ACR criteria were applied in 23 adult and 13 pediatric studies, the 2012 SLICC criteria in 22 adult and 13 pediatric studies, and the 2019 EULAR/ACR criteria in 17 adult and 10 pediatric studies. Except for sensitivity and AUC for the 2012 SLICC criteria, there were no statistically significant differences in diagnostic accuracy and AUCResults： between the three criteria in both adult and pediatric SLE. For pediatric SLE, the 1997 ACR criteria showed 5 true positives (4-5) and 1 false positive (1-2) per 100,000 people, while the 2012 SLICC and 2019 EULAR/ACR criteria showed 6 true positives (6-6) and 0 false positives (0-0) per 100,000 people. Based on the GRADE evaluation, the evidence body was rated as low quality by downgrading two levels in the meta-analysis for adult SLE using the three criteria while the GRADE result was moderate quality by downgrading 1 level in the meta-analysis for pediatric SLE. Conclusion：In both pediatric and adult SLE, the 2012 SLICC and 2019 EULAR/ACR criteria demonstrated superior diagnostic performance compared to the 1997 ACR criteria, with similar diagnostic accuracy. The misdiagnosis rate of the 2012-SLICC and 2019-EULAR/ACR classification criteria in pediatric SLE is zero.

Key words: Systemic lupus erythematosus, Classification criteria, Children, Diagnostic value, Sensitivity, Specificity, Meta-analysis