目的: 探讨抗磷脂酰丝氨酸/凝血酶原抗体及其IgG或IgM亚型是否与不明原因复发性流产相关。方法: 选择2021年1月至2023年8月在北京大学第三医院就诊的年龄18~40岁且检测过抗磷脂酰丝氨酸/凝血酶原抗体的283例至少一次不明原因流产患者的病例资料进行回顾性分析, 使用卡方检验和Logistic回归分析抗磷脂酰丝氨酸/凝血酶原抗体及其IgG或IgM亚型与不明原因复发性流产的相关性, 使用四格表法计算抗磷脂酰丝氨酸/凝血酶原抗体及其IgG或IgM亚型在不明原因复发性流产中的灵敏度、特异度、阳性预测值和阴性预测值。结果: 卡方检验表明, 复发性流产组抗磷脂酰丝氨酸/凝血酶原抗体及其IgM亚型阳性率高于非复发性流产组(P均＜0.05), 而抗PS/PT抗体IgG亚型阳性率在两组间的差异无统计学意义(P>0.05)。以抗心磷脂抗体、抗β₂糖蛋白抗体、狼疮抗凝物、抗核抗体以及年龄校正后, Logistic回归分析发现抗磷脂酰丝氨酸/凝血酶原抗体阳性与复发性流产相关(OR=2.084, 95%CI 1.045~4.155, P＜0.05), 抗磷脂酰丝氨酸/凝血酶原抗体IgM亚型与复发性流产相关(OR=2.368, 95%CI 1.187~4.722, P＜0.05)。抗磷脂酰丝氨酸/凝血酶原抗体诊断复发性流产的灵敏度为65.43%, 特异度为48.51%, 阳性预测值为33.76%, 阴性预测值为77.78%。在经典抗磷脂抗体阴性的复发性流产患者中, 抗磷脂酰丝氨酸/凝血酶原抗体的灵敏度为59.09%, 特异度为63.23%, 阳性预测值为40.63%, 阴性预测值为78.40%。抗磷脂酰丝氨酸/凝血酶原抗体IgM亚型诊断复发性流产的灵敏度为65.43%, 特异度为50.99%, 阳性预测值为34.87%, 阴性预测值为78.63%。结论: 抗磷脂酰丝氨酸/凝血酶原抗体及IgM亚型阳性与至少一次不明原因流产患者的复发性流产相关, 其在不明原因复发性流产诊断中是否有预测价值尚需要未来前瞻性研究确定。

Objective: To investigate whether anti-phosphatidylserine/prothrombin antibodies and its IgG or IgM subtypes were correlated with unexplained recurrent miscarriages. Methods: In our a single-center retrospective study, 283 patients with at least one unexplained miscarriage who visited the Third Hospital of Peking University between January 2021 and August 2023, aged between 18-40 years, and tested for anti-phosphatidylserine/prothrombin antibodies IgG or IgM subtypes, were included. The patients with either positive IgG or IgM anti-phosphatidylserine/prothrombin antibody were regarded as positive for anti-phosphatidylserine/prothrombin antibody. SPSS 26.0 software was used for statistical analysis. Chi-square test and Logistic regression analysis were used to study the correlation of anti-phosphatidylserine/prothrombin antibodies and its IgG or IgM subtypes with unexplained recurrent miscarriages. And the diagnostic sensitivity, specificity, the positive predictive value, the negative predictive value of anti-phosphatidylserine/prothrombin antibodies and its IgG or IgM subtypes in unexplained miscarriages was calculated with four-fold table. Results: Chi-square analysis showed that anti-phosphatidylserine/prothrombin antibodies and its IgM subtypes were correlated with recurrent miscarriages (both P < 0.05), while the IgG subtype was not correlated with recurrent miscarriages (P>0.05). After adjusting with anticardiolipin antibodies, anti-β₂ glycoprotein antibodies, lupus anticoagulants, antinuclear antibodies, and age by Logistic regression analysis, anti-phosphatidylserine/prothrombin antibodies were correlated with unexplained recurrent miscarriages (OR=2.084, 95%CI 1.045-4.155, P < 0.05), and anti-phosphatidylserine/prothrombin antibody IgM subtypes were correlated with unexplained recurrent miscarriages (OR=2.368, 95%CI 1.187-4.722, P < 0.05).The sensitivity of anti-phosphatidylserine/prothrombin antibody in recurrent miscarriage was 65.43%, the specificity was 48.51%, the positive predictive value was 33.76%, and the negative predictive value was 77.78%. In the patients with recurrent miscarriages with negative classical antiphospholipid antibodies, the sensitivity of anti-phosphatidylserine/prothrombin antibody was 59.09%, the specificity was 63.23%, the positive predictive value was 40.63%, and the negative predictive value was 78.40%. The sensitivity of the anti-phosphatidylserine/prothrombin antibody IgM subtype for the diagnosis of recurrent miscarriage was 65.43%, the specificity was 50.99%, the positive predictive value was 34.87%, and the negative predictive value was 78.63%. Conclusion: Anti-phosphatidylserine/prothrombin antibody and IgM subtype antibody are correlated with unexplained recurrent miscarriages in patients with at least one unexplained miscarriage. Whether positive anti-phosphatidylserine/prothrombin antibody or IgM subtype could predict future unexplained recurrent miscarriages warrants a prospective study.