Department of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Department of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
J Autoimmun. 2024 Jun;146:103237. doi: 10.1016/j.jaut.2024.103237. Epub 2024 May 14.
To evaluate the effectiveness of the 2023 ACR/EULAR criteria for antiphospholipid syndrome (APS) in a Chinese cohort, and compare them with the Sapporo and revised Sapporo criteria.
A cohort comprising 436 patients diagnosed with APS and 514 control subjects was enrolled, including 83 with seronegative APS and 86 classified as antiphospholipid antibody (aPL) carriers. We assessed IgG and IgM anticardiolipin antibodies (aCL) and anti-β2-glycoprotein I (aβ2GPI) antibodies using ELISA, along with a systematic collection of lupus anticoagulant data. Subsequently, we compared the sensitivity and specificity across the three classification criteria.
The 2023 ACR/EULAR criteria exhibited improved specificity at 98 %, surpassing the revised Sapporo (90 %) and original Sapporo (91 %) criteria. However, this came with decreased sensitivity at 82 %, in contrast to higher sensitivities in the revised Sapporo (98 %) and Sapporo (91 %) criteria. Examining individual components sheds light on the scoring system's rationale within the new criteria. The inclusion of microvascular thrombosis, cardiac valve disease, and thrombocytopenia improved the identification of nine patients previously classified as "probable APS". Insufficient scoring in 78 previously diagnosed APS individuals was linked to traditional risk factor evaluations for thrombotic events, the emphasis on determining whether obstetric events are linked to severe preeclampsia (PEC) or placental insufficiency (PI), and the lower scores assigned to IgM aCL and/or aβ2GPI antibody. Seronegative APS remained a challenge, as non-criteria aPL and other methods were not included.
The new criteria presented notable advancements in specificity. This study provides detailed insights into the strengths and possible challenges of the 2023 ACR/EULAR criteria, enhancing our understanding of their impact on clinical practice.
评估 2023 年 ACR/EULAR 抗磷脂综合征（APS）标准在中国人群中的有效性，并将其与 Sapporo 和修订后的 Sapporo 标准进行比较。
本研究纳入了 436 例 APS 患者和 514 例对照者，其中包括 83 例血清阴性 APS 患者和 86 例抗磷脂抗体（aPL）携带者。我们使用 ELISA 检测 IgG 和 IgM 抗心磷脂抗体（aCL）和抗-β2-糖蛋白 I（aβ2GPI）抗体，并系统收集狼疮抗凝物数据。随后，我们比较了三种分类标准的敏感性和特异性。
2023 年 ACR/EULAR 标准的特异性为 98%，优于修订后的 Sapporo（90%）和原始 Sapporo（91%）标准。然而，敏感性降低至 82%，而修订后的 Sapporo（98%）和 Sapporo（91%）标准的敏感性更高。检查单个组成部分揭示了新标准中评分系统的原理。微血管血栓形成、心脏瓣膜疾病和血小板减少症的纳入提高了 9 例以前被归类为“可能的 APS”患者的识别率。78 例以前诊断为 APS 的患者评分不足与血栓事件的传统危险因素评估、强调确定产科事件是否与严重子痫前期（PEC）或胎盘功能不全（PI）相关，以及 IgM aCL 和/或 aβ2GPI 抗体的评分较低有关。血清阴性 APS 仍然是一个挑战，因为未纳入非标准 aPL 和其他方法。
新的标准在特异性方面有显著的进步。本研究详细介绍了 2023 年 ACR/EULAR 标准的优势和可能的挑战，增强了我们对其对临床实践影响的理解。
