Li Linhui, Chen Jian, Feng Jing, Zhao Hong, Liu Xiaojuan, Jiang Yongmei
Department of Laboratory Medicine, West China Second University Hospital, Sichuan University, Chengdu, China.
Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Sichuan University, Chengdu, China.
Front Immunol. 2025 Apr 23;16:1541165. doi: 10.3389/fimmu.2025.1541165. eCollection 2025.
Anti-β2 glycoprotein I domain 1 (anti-β2GPI-D1) antibodies have shown promise as diagnostic and prognostic markers for antiphospholipid syndrome (APS), but their clinical significance remains uncertain. This systematic review and meta-analysis evaluated the diagnostic accuracy of anti-β2GPI-D1 for APS and its association with thrombotic risk. A comprehensive search was conducted across PubMed, Web of Science, and Embase up to July 18, 2024. Eighteen studies (2,060 APS patients and 3,013 controls) were included in the diagnostic analysis, revealing a pooled sensitivity of 52% (95% CI 46%-58%) and specificity of 95% (95% CI 88%-98%). Anti-β2GPI-D1 demonstrated strong diagnostic value in distinguishing APS from other autoimmune diseases and healthy individuals, though its utility in differentiating APS from aPL carriers was limited. Additionally, five prospective cohort studies (210 APS patients, 430 aPL carriers, and 42 SLE patients) showed that anti-β2GPI-D1 was associated with an increased risk of thrombosis (pooled RR 1.75, 95% CI 1.07-2.87). Our findings suggest that anti-β2GPI-D1 offers high specificity and moderate sensitivity for APS diagnosis and may serve as a predictor of thrombosis.
抗β2糖蛋白I结构域1（抗β2GPI-D1）抗体已显示出作为抗磷脂综合征（APS）诊断和预后标志物的潜力，但其临床意义仍不明确。本系统评价和荟萃分析评估了抗β2GPI-D1对APS的诊断准确性及其与血栓形成风险的关联。截至2024年7月18日，在PubMed、科学网和Embase上进行了全面检索。诊断分析纳入了18项研究（2060例APS患者和3013例对照），汇总敏感性为52%（95%CI 46%-58%），特异性为95%（95%CI 88%-98%）。抗β2GPI-D1在区分APS与其他自身免疫性疾病和健康个体方面具有较强的诊断价值，但其在区分APS与抗磷脂抗体（aPL）携带者方面的效用有限。此外，五项前瞻性队列研究（210例APS患者、430例aPL携带者和42例系统性红斑狼疮患者）表明，抗β2GPI-D1与血栓形成风险增加相关（汇总RR 1.75，95%CI 1.07-2.87）。我们的研究结果表明，抗β2GPI-D1对APS诊断具有高特异性和中等敏感性，可能作为血栓形成的预测指标。
