狼疮抗凝物是抗磷脂抗体阳性患者不良妊娠结局的主要预测因子：PROMISSE 研究结果的验证。
Lupus anticoagulant is the main predictor of adverse pregnancy outcomes in aPL-positive patients: validation of PROMISSE study results.
机构信息
Department of Medicine, Hospital for Special Surgery, New York City, New York, USA; Internal Medicine Department, University of Lille, UFR Médecine, Lille, France.
University of Toronto and LifeQuest Centre for Reproductive Medicine , Toronto , Canada.
出版信息
Lupus Sci Med. 2016 Jan 12;3(1):e000131. doi: 10.1136/lupus-2015-000131. eCollection 2016.
OBJECTIVE
We previously reported that lupus anticoagulant (LAC) is the main predictor of poor pregnancy outcome in antiphospholipid antibody (aPL)-positive patients. We sought to confirm this finding in an independent group of patients who were subsequently recruited into the PROMISSE study.
METHODS
The PROMISSE study is a multicentre, prospective, observational study of pregnancy outcomes in women with aPL and/or systemic lupus erythematosus (SLE) that enrolled patients from 2003 to 2015. All consecutive, aPL-positive patients from the PROMISSE study who completed their pregnancy between April 2011 and January 2015 (after the previous PROMISSE report) are included in the current report. Patients were followed monthly until delivery, and aPL was tested at first, second and third trimesters of pregnancy and at 12 weeks post partum. Adverse pregnancy outcomes (APOs) were defined as fetal death after 12 weeks of gestation, neonatal death, delivery prior to 36 weeks of gestation due to pre-eclampsia or placental insufficiency or small-for-gestational age (birth weight <5th percentile).
RESULTS
Forty-four aPL-positive patients are included in this paper. Thirteen patients had APOs, which occurred in 80% of cases during the second trimester of pregnancy. LAC was present in 69% of patients with APOs compared with 27% of patients without APOs (p=0.01). No association was found between anticardiolipin antibodies (aCL) or anti-β2 glycoprotein I antibodies (aβ2GPI) IgG or IgM positivity and APOs. Definite antiphospholipid syndrome (history of thrombosis and/or pregnancy morbidity and aPL) was found in 92% of patients with any APOs compared with 45% of patients without APOs (p=0.004). Conversely, the frequency of SLE was not statistically different between those with and without APOs (30% vs 39%).
CONCLUSIONS
Our findings, in an independent group of aPL-positive patients from the PROMISSE study, confirm that LAC, but not aCL and aβ2GPI, is predictive of poor pregnancy outcomes after 12 weeks of pregnancy.
TRIAL REGISTRATION NUMBER
NCT00198068.
目的
我们之前报道过狼疮抗凝物（LAC）是抗磷脂抗体（aPL）阳性患者不良妊娠结局的主要预测因素。我们试图在随后被纳入 PROMISSE 研究的一组独立患者中证实这一发现。
方法
PROMISSE 研究是一项针对抗磷脂抗体和/或系统性红斑狼疮（SLE）患者妊娠结局的多中心、前瞻性、观察性研究，该研究于 2003 年至 2015 年期间招募患者。所有来自 PROMISSE 研究的连续抗磷脂抗体阳性患者，在 2011 年 4 月至 2015 年 1 月期间完成妊娠（在之前的 PROMISSE 报告之后），都包含在本报告中。患者在妊娠期间每月随访至分娩，在妊娠第 1、2 和 3 个月以及产后 12 周检测 aPL。不良妊娠结局（APO）定义为妊娠 12 周后胎儿死亡、新生儿死亡、因子痫前期或胎盘功能不全或小于胎龄儿（出生体重 <第 5 百分位数）而在 36 周前分娩。
结果
本研究共纳入 44 例抗磷脂抗体阳性患者。13 例患者发生 APO，其中 80%发生在妊娠中期。发生 APO 的患者中 LAC 阳性率为 69%，而无 APO 的患者为 27%（p=0.01）。抗心磷脂抗体（aCL）或抗β2 糖蛋白 I 抗体（aβ2GPI）IgG 或 IgM 阳性与 APO 之间无相关性。任何 APO 患者的明确抗磷脂综合征（血栓形成和/或妊娠并发症病史和 aPL）发生率为 92%，而无 APO 患者为 45%（p=0.004）。相反，有和无 APO 患者的 SLE 发生率无统计学差异（30%比 39%）。
结论
在 PROMISSE 研究的一组独立抗磷脂抗体阳性患者中，我们的研究结果证实，LAC 而不是 aCL 和 aβ2GPI 可预测妊娠 12 周后不良妊娠结局。
试验注册
NCT00198068。
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