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抗磷脂抗体阳性患者的妊娠结局:来自抗磷脂抗体综合征临床研究和国际网络联盟(APS ACTION)临床数据库和存储库(“注册中心”)的前瞻性结果。

Pregnancy outcomes in antiphospholipid antibody positive patients: prospective results from the AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Networking (APS ACTION) Clinical Database and Repository ('Registry').

机构信息

Divison of Rheumatology, Hospital for Special Surgery, New York, New York, USA.

Medicine, Yeshiva University Albert Einstein College of Medicine, Bronx, New York, USA.

出版信息

Lupus Sci Med. 2022 Jun;9(1). doi: 10.1136/lupus-2021-000633.

Abstract

OBJECTIVES

To describe the outcomes of pregnancies in antiphospholipid antibody (aPL)-positive patients since the inception of the AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Networking Registry.

METHODS

We identified persistently aPL-positive patients recorded as 'pregnant' during prospective follow-up, and defined as a composite of: (1) Preterm live delivery (PTLD) at or before 37th week due to pre-eclampsia (PEC), eclampsia, small-for-gestational age (SGA) and/or placental insufficiency (PI); or (2) Otherwise unexplained fetal death after the 10th week of gestation. The primary objective was to describe the characteristics of patients with and without aPL-related composite outcomes based on their first observed pregnancies following registry recruitment.

RESULTS

Of the 55 first pregnancies observed after registry recruitment among nulliparous and multiparous participants, 15 (27%) resulted in early pregnancy loss <10 weeks gestation. Of the remaining 40 pregnancies: (1) 26 (65%) resulted in term live delivery (TLD), 4 (10%) in PTLD between 34.0 weeks and 36.6 weeks, 5 (12.5%) in PTLD before 34th week, and 5 (12.5%) in fetal death (two associated with genetic anomalies); and (2) The aPL-related composite outcome occurred in 9 (23%). One of 26 (4%) pregnancies with TLD, 3/4 (75%) with PTLD between 34.0 weeks and 36.6 weeks, and 3/5 (60%) with PTLD before 34th week were complicated with PEC, SGA and/or PI. Fifty of 55 (91%) pregnancies were in lupus anticoagulant positive subjects, as well as all pregnancies with aPL-related composite outcome.

CONCLUSION

In our multicentre, international, aPL-positive cohort, of 55 first pregnancies observed prospectively, 15 (27%) were complicated by early pregnancy loss. Of the remaining 40 pregnancies, composite pregnancy morbidity was observed in 9 (23%) pregnancies.

摘要

目的

描述自抗磷脂抗体(aPL)阳性患者抗磷脂综合征联盟临床试验和国际网络注册成立以来的妊娠结局。

方法

我们在前瞻性随访中确定了记录为“妊娠”的持续 aPL 阳性患者,并将其定义为以下两种情况的复合:(1)因先兆子痫(PEC)、子痫、胎儿小于胎龄(SGA)和/或胎盘功能不全(PI)而在 37 周前早产(PTLD);或(2)妊娠 10 周后不明原因的胎儿死亡。主要目的是根据注册后首次观察到的妊娠,描述有和无 aPL 相关复合结局的患者的特征。

结果

在招募登记后的 55 例初产妇和经产妇中,有 15 例(27%)妊娠早期流产<10 周。在剩余的 40 例妊娠中:(1)26 例(65%)足月活产(TLD),4 例(10%)在 34.0 周到 36.6 周之间发生早产(PTLD),5 例(12.5%)在 34 周前发生早产(PTLD),5 例(12.5%)发生胎儿死亡(其中 2 例与遗传异常有关);(2)aPL 相关复合结局发生在 9 例(23%)中。26 例 TLD 妊娠中,有 1 例(4%),4 例(75%)在 34.0 周到 36.6 周之间发生 PTLD,5 例(60%)在 34 周前发生 PTLD,合并 PEC、SGA 和/或 PI。55 例妊娠中有 50 例(91%)为狼疮抗凝物阳性,所有发生 aPL 相关复合结局的妊娠均为阳性。

结论

在我们的多中心、国际、aPL 阳性队列中,前瞻性观察到的 55 例初产妇中,有 15 例(27%)妊娠早期流产。在剩余的 40 例妊娠中,9 例(23%)发生复合妊娠并发症。

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