Effendi Muhammad Umer Naeem, Majid Hafsa, Moiz Bushra, Jafri Lena, Zehra Nawazish, Khan Aysha Habib
Section of Chemical Pathology, Department of Pathology and Laboratory Medicine, Aga Khan University, Karachi, Sindh, Pakistan.
Section of Hematology, Department of Pathology and Laboratory Medicine, Aga Khan University, Karachi, Sindh, Pakistan.
Int J Immunopathol Pharmacol. 2025 Jan-Dec;39:3946320251316724. doi: 10.1177/03946320251316724.
The objectives of this study were to determine the prevalence of anti-β2glycoprotein-1 antibodies (anti-β2GPI) in Pakistani patients clinically suspected to have antiphospholipid syndrome (APS) and assess their association with clinical manifestations.
The antiphospholipid syndrome (APS) is a complex disorder characterized by recurrent thrombotic and obstetric complications.
An analytical cross-sectional study was conducted at Aga Khan University Hospital from January to June 2022, after obtaining ethical approval (ERC ID: 2021-6404-19580). A total of 133 patients aged 18-60 years, clinically suspected of having APS based on the updated international consensus (Sydney) classification criteria, were recruited. Anti-β2GPI antibodies were tested using the same blood samples provided for aCL testing, with verbal consent. Demographic, clinical, and biochemical data were collected via a structured questionnaire, while information on lupus anticoagulant testing was retrospectively obtained from prior records.
The study included 120 females (90.2%) and 13 males (9.8%) with a mean age of 31.3 ± 8.8 years. Predominant clinical manifestations included unexplained miscarriages at >10 weeks of gestation ( = 77/120 female, 64.2%), while deep venous thrombosis (DVT) was a common non-obstetric clinical feature ( = 18/133, 13.5%). The median level of anti-β2GPI was 2.12 U/ml (1.34-7.04) and 7.5% ( = 10) were positive. Of the 10 positive patients, 2 displayed positive anti-β2GPI while concurrently testing negative for other aPL antibodies. A significant association was identified between the presence of anti-β2GPI and the occurrence of DVT and other venous thromboembolic events (VTE).
This study highlights the prevalence and diagnostic utility of anti-β2GPI in Pakistani patients suspected of APS, identifying cases missed by other aPL tests and showing significant associations with thrombotic manifestations like DVT and VTE. However, the cross-sectional design, lack of confirmatory testing, and absence of locally derived cut-offs limit causal inferences.
本研究的目的是确定临床怀疑患有抗磷脂综合征（APS）的巴基斯坦患者中抗β2糖蛋白-1抗体（抗β2GPI）的患病率，并评估其与临床表现的关联。
抗磷脂综合征（APS）是一种复杂的疾病，其特征为反复出现血栓形成和产科并发症。
在获得伦理批准（ERC编号：2021-6404-19580）后，于2022年1月至6月在阿迦汗大学医院进行了一项分析性横断面研究。共招募了133名年龄在18至60岁之间、根据最新国际共识（悉尼）分类标准临床怀疑患有APS的患者。在获得口头同意后，使用为检测抗心磷脂（aCL）而提供的相同血样检测抗β2GPI抗体。通过结构化问卷收集人口统计学、临床和生化数据，而狼疮抗凝物检测信息则从既往记录中回顾性获取。
该研究纳入了120名女性（90.2%）和13名男性（9.8%），平均年龄为31.3±8.8岁。主要临床表现包括妊娠10周以上原因不明的流产（120名女性中有77名，64.2%），而深静脉血栓形成（DVT）是常见的非产科临床特征（133名中有18名，13.5%）。抗β2GPI的中位数水平为2.12 U/ml（1.34 - 7.04），7.5%（10名）为阳性。在这10名阳性患者中，2名在检测其他抗磷脂抗体（aPL）时抗β2GPI呈阳性而其他抗体呈阴性。抗β2GPI的存在与DVT及其他静脉血栓栓塞事件（VTE）的发生之间存在显著关联。
本研究突出了抗β2GPI在疑似APS的巴基斯坦患者中的患病率及诊断效用，识别出其他aPL检测遗漏的病例，并显示出与DVT和VTE等血栓形成表现的显著关联。然而，横断面设计、缺乏确证性检测以及缺乏本地得出的临界值限制了因果推断。
