Table_1_Diagnostic accuracy of the European League against rheumatism/American College of Rheumatology-2019 versus the Systemic Lupus International Collaborating Clinics-2012 versus the ACR-1997 classification criteria in adult systemic lupus erythematosus: A systematic review and meta-analysis.docx

AimTo evaluate the diagnostic performance of the American College of Rheumatology (ACR)-1997, the Systemic Lupus International Collaborating Clinics (SLICC)-2012, and the European League against Rheumatism (EULAR)/ACR-2019 classification criteria in adult patients with systemic lupus erythematosus (SLE).
MethodsPubMed, Embase, Web of Science and Cochrane Library databases were searched for literature comparing the three classification criteria of ACR-1997, SLICC-2012 and EULAR/ACR-2019, which took clinical diagnosis as reference. Meta-analysis was used to evaluate and compare the sensitivity, specificity and diagnostic odds ratio of ACR-1997, SLICC-2012 and EULAR/ACR-2019. To assess the early diagnosis capability of the classification criteria, subgroups of patients with disease duration < 3 years and < 1 year were selected for comparison of sensitivity and specificity based on the inclusion of the original study. The sensitivity and specificity of each item in three sets of classification criteria were evaluated. In addition, the clinical and immunological characteristics of patients who did not meet the three classification criteria were compared.
ResultsNine original studies were included in the analysis, including 6404 SLE patients and 3996 controls. Results showed that the diagnostic odds ratios (95% confidence interval) of the SLICC-2012 [136.35 (114.94, 161.75)] and EULAR/ACR-2019 [187.47 (158.00, 222.42)] were higher than those of the ACR-1997 [67.53 (58.75, 77.63)]. Compared with ACR-1997[(0.86 (0.82, 0.89)], SLICC-2012[(0.96 (0.93, 0.97)] and EULAR/ACR-2019[(0.95 (0.92, 0.97)] had higher sensitivity. The specificity of the three classification criteria was similar: ACR-1997, SLICC-2012, and EULAR/ACR-2019 were 0.93 (0.89, 0.95), 0.86 (0.79, 0.91), and 0.91 (0.85, 0.95), respectively. The sensitivity of SLICC-2012 and EULAR/ACR-2019 were higher than that of ACR-1997 in early-course subgroups. Patients who did not meet ACR-1997 had more hypocomplementemia, patients who did not meet SLICC-2012 had more cutaneous lupus and photosensitivity, and patients who did not meet EULAR/ACR-2019 had more cutaneous lupus and leucopenia.
ConclusionsSLICC-2012 and EULAR/ACR-2019 have better diagnostic ability than the ACR-1997, and the sensitivity of the former two criteria is also higher than that of the latter; Moreover, the SLICC-2012 and EULAR/ACR-2019 for patients in the early stages of disease performed equally excellent.

研究目的：本研究旨在评估美国风湿病学会（American College of Rheumatology, ACR）1997年标准、系统性狼疮国际合作诊所（Systemic Lupus International Collaborating Clinics, SLICC）2012年标准以及欧洲抗风湿病联盟/美国风湿病学会（European League against Rheumatism, EULAR/ACR）2019年标准对成人系统性红斑狼疮（systemic lupus erythematosus, SLE）患者的诊断效能。
研究方法：检索PubMed、Embase、Web of Science及Cochrane Library数据库，筛选以临床诊断为金标准、比较ACR-1997、SLICC-2012及EULAR/ACR-2019三种分类标准的相关文献。采用Meta分析方法评估并比较三种标准的敏感度、特异度及诊断比值比。为评估分类标准的早期诊断能力，依据原始研究的纳入标准，选取病程<3年及<1年的患者亚组进行敏感度与特异度的对比分析。同时评估三种分类标准各条目的诊断效能，并对未满足三种分类标准的患者的临床及免疫学特征进行比较。
研究结果：本研究共纳入9项原始研究，涉及6404例SLE患者及3996例对照人群。结果显示，SLICC-2012[136.35（95%置信区间：114.94, 161.75）]与EULAR/ACR-2019[187.47（95%置信区间：158.00, 222.42）]的诊断比值比均高于ACR-1997[67.53（95%置信区间：58.75, 77.63）]。与ACR-1997[0.86（95%置信区间：0.82, 0.89）]相比，SLICC-2012[0.96（95%置信区间：0.93, 0.97）]与EULAR/ACR-2019[0.95（95%置信区间：0.92, 0.97）]的敏感度更高。三种分类标准的特异度较为接近：ACR-1997、SLICC-2012及EULAR/ACR-2019的特异度分别为0.93（95%置信区间：0.89, 0.95）、0.86（95%置信区间：0.79, 0.91）及0.91（95%置信区间：0.85, 0.95）。在早期病程亚组中，SLICC-2012与EULAR/ACR-2019的敏感度均高于ACR-1997。未满足ACR-1997标准的患者更易出现低补体血症；未满足SLICC-2012标准的患者更多表现为皮肤狼疮及光敏感；未满足EULAR/ACR-2019标准的患者则更多出现皮肤狼疮及白细胞减少症。
研究结论：SLICC-2012与EULAR/ACR-2019的诊断效能优于ACR-1997，且前两者的敏感度亦高于后者；此外，二者对于早期病程患者的诊断表现同样优异。