目的 探讨检测24种抗磷脂抗体的抗体谱对诊断和鉴别诊断抗磷脂综合征(antiphospholipid syndrome, APS)病态妊娠的临床意义。方法 采用病例对照研究。收集2013年1月至2015年9月北京协和医院风湿免疫科确诊为APS并有不良孕史的28例患者,和2014年1月至2015年2月同院确诊的除外APS的有不良孕史的患者34例和同期健康体检者39名。用酶联免疫吸附试验(enzyme-linked immununosorbent assay, ELISA)检测待检者抗心磷脂抗体(anticardiolipin,CL)、抗β2糖蛋白1抗体(anti-β2-glycoprotein 1,aβ2GP1)、抗膜联蛋白A5抗体(anti-annexin-A5 antibodies,aAXN5)、抗凝血酶原抗体(anti-prothrombin antibodies,aPT)、抗磷脂酰丝氨酸抗体(anti-phosphatidylserine antibodies,aPS)、抗磷脂酰乙醇胺抗体(anti-phosphatidylethanolamine antibodies,aPE)、抗磷脂酰肌醇抗体(anti-phosphatidylinositol antibodies,aPI)、抗磷脂酰胆碱抗体(anti-phosphatidylcholine antibodies,aPC)、抗鞘磷脂抗体(anti-sphingomyelin antibodies,aSPH)和抗凝血酶原/丝氨酸复合物抗体(anti-phosphatidylserine-prothrombin complex antibodies,aPT/PS)水平,并用改良的稀释蝰毒时间法(Dilute Russell′s viper venom time,dRVVT)检测狼疮抗凝物(lupus anticoagulant,LA)水平。然后,用卡方检验(理论频数T<5时,采用Fisher精确检验)比较APS病态妊娠组、非APS病态妊娠组及健康对照组中24种抗磷脂抗体的阳性率;同时进行不同组间抗体浓度比较分析,并以APS临床诊断为金标准,用四格表统计抗磷脂抗体诊断APS的效能。结果 APS病态妊娠组的aCL-IgM、aβ2GP1-IgG、aβ2GP1-IgA、aPT/PS-IgG、aPT/PS-IgM、aPS-IgG、aPI-IgG及LA的阳性率显著高于非APS病态妊娠组(P值分别为<0.0001、0.015、0.037、<0.0001、0.030、0.018、<0.0001和<0.0001)。LA对鉴别诊断APS病态妊娠与非APS病态妊娠的敏感度最高(75%),其次为IgG aPT/PS(57.1%)和 IgM aCL(50%)。除aPT/PS-IgM鉴别诊断AP
Objective To evaluate the clinical significance of24antiphospholipid antibodies in pregnant women with antiphospholipid syndrome(APS).Methods Case-control study was carried out:28APS pregnant women,34non-APS pregnant women and39health controls were enrolled.Anti-cardiolipin(aCL),anti-β2-glycoprotein1(aβ2GP1),anti-annexin-A5anti-prothrombin antibodies(aPT),anti-phosphatidylserine antibodies aPS,anti-phosphatidyl ethanolamine antibodies(aPE),anti-phosphatidyl inositol antibodies(aPI),anti-phosphatidyl choline antibodies(aPC),anti-sphingomyelin antibodies(aSPH),antibodies(aAXN5),and anti-phosphatidylserine-prothrombin complex antibodies(aPT/PS)were detected by enzyme-linked immununosorbent assay(ELISA).Lupus anticoagulant(LA)was tested by Dilute Russell′s viper venom time(dRVVT).The prevalence of antiphospholipid antibodies in the three groups were compared(Chi-Square test or Fisher′s exact test).The antibody levels in different groups were compared using nonparametric Mann-Whitney U tests.The diagnostic efficacy of antiphospholipid antibodies was analyzed by cross table using clinical diagnosis of APS as gold standard.Results The prevalence of aCL-IgM,aβ2GP1-IgG,aβ2GP1-IgA,aPT/PS-IgG,aPT/PS-IgM,aPS-IgG,aPI-IgG,and LA were higher in APS pregnant women than those in non-APS pregnant women(P<0.0001,P<0.015,P<0.037,P<0.0001,P<0.030,P<0.018,P<0.0001,and P<0.001,respectively).For differentiating APS pregnant woman from non-APS pregnant woman,LA displayed the highest sensitivity(75%),followed by IgG aPT/PS(57.1%)and IgM aCL(50%).All the aPLs,except aPT/PS-IgM demonstrated a high specificity(>97.1%)in differentiating APS pregnant women from non-APS in pregnant women.Although there was no significantly differenct prevalence of aPLs between patients with thrombosis and without thrombosis,the median levels of aCL-IgM[19.3(43.2)MPL/ml vs8.3(17.7)MPL/ml],aPT/PS-IgG[71.4(78.2)U/ml vs16.7(31.5)U/ml],aPT/PS-IgM[95.0(127.7)U/ml vs15.3(15.1)U/ml],aPT-IgG[9.1(18.1)U/ml vs5.0(4.1)U/ml]and LA[1.70(0.29)vs1.21(0.41)]were signifi