Papadakis E, Pouliakis A, Aktypi Α, Christoforidou A, Kotsi P, Αnagnostou G, Foifa A, Grouzi E
1Hemostasis Unit-Hematology Department Papageorgiou Hospital, Thessaloniki Ringroad 56403 Nea Efkarpia, Thessaloniki, Greece.
22nd Department of Pathology, National and Kapodistrian University of Athens, "ATTIKON" University Hospital, Rimini 1 Haidari, Athens, Greece.
Thromb J. 2019 Dec 4;17:23. doi: 10.1186/s12959-019-0213-9. eCollection 2019.
Use of LMWH in pregnancy is not only limited to VTE management, but it extends, to the management of vascular gestational complications and the optimization of IVF pregnancies despite the lack of concrete scientific evidence. In this context, we conducted the present study aiming to gain insights regarding the use of LMWH during pregnancy and puerperium. We recorded indication for use, diagnostic work-up as well as the safety and efficacy of the treatment, trying to elucidate the clinical practice in our country.
We analyzed data regarding 818 pregnant women received LMWH during 2010-2015.Our cohort had a median age of 33.9 years and a BMI of 23.6.There were 4 groups: those with a history of VTE [Group-A: 76], those with pregnancy complications [Group-B: 445], those undergoing IVF [Group-C: 132] and those carrying prothrombotic tendency (thrombophilia, family history of VTE, other) [Group-D: 165]. Mean duration of LMWH administration was 8.6 ± 1.5 months. Out of the total number, 440 received LMWH in fixed prophylactic dose, 272 in higher prophylactic-weight adjusted dose and 106 in therapeutic dose. Moreover, 152 women received in addition low-dose acetylsalicylic acid (ASA). 93.8% of pregnancies were single and 6.2% were multiple ones. Live births occurred in 98.7% of pregnancies.
Anticoagulation was efficacious and well tolerated. Seventeen VTE events were recorded; 7 of them antepartum and 10 postpartum. No major bleeding events were observed while 13 clinical relevant non-major bleeding events were recorded. Regarding gestational vascular complications, 28 IUGR events were recorded, as well as 48 cases of preterm labor of which 12 were concomitant with IUGR (25%). Six early pregnancy losses were recorded; there were 3 fetal deaths and 3 cases of pre-eclampsia/eclampsia.
LMWHs are used extensively during pregnancy and puerperium in Greece for VTE treatment and prophylaxis and for a variety of other indications as well. Although the drug has been shown to be both safe and efficacious, its use for some indications has no proven scientific evidence. In order to clearly define the role of LMWHs in pregnancy, beyond thromboprophylaxis, large prospective studies are required, which could be based on the conclusions of this study.
低分子肝素(LMWH)在孕期的应用不仅局限于静脉血栓栓塞症(VTE)的管理,还扩展到血管性妊娠并发症的管理以及体外受精(IVF)妊娠的优化,尽管缺乏确凿的科学证据。在此背景下,我们开展了本研究,旨在深入了解LMWH在孕期及产褥期的使用情况。我们记录了使用指征、诊断检查以及治疗的安全性和有效性,试图阐明我国的临床实践情况。
我们分析了2010年至2015年期间接受LMWH治疗的818名孕妇的数据。我们的队列中位年龄为33.9岁,体重指数(BMI)为23.6。分为4组:有VTE病史的患者[ A组:76例],有妊娠并发症的患者[ B组:445例],接受IVF治疗的患者[ C组:132例]以及有血栓形成倾向(血栓ophilia、VTE家族史、其他)的患者[ D组:165例]。LMWH的平均给药时间为8.6±1.5个月。在总数中,440例接受固定预防剂量的LMWH,272例接受更高预防剂量(根据体重调整),106例接受治疗剂量。此外,152名妇女还额外接受了低剂量乙酰水杨酸(ASA)治疗。93.8%的妊娠为单胎,6.2%为多胎。98.7%的妊娠实现了活产。
抗凝治疗有效且耐受性良好。记录到17例VTE事件;其中7例发生在产前,10例发生在产后。未观察到重大出血事件,但记录到13例临床相关的非重大出血事件。关于妊娠血管并发症,记录到28例胎儿生长受限(IUGR)事件,以及48例早产病例,其中12例伴有IUGR(25%)。记录到6例早期妊娠丢失;有3例胎儿死亡和3例先兆子痫/子痫病例。
在希腊,LMWH在孕期及产褥期被广泛用于VTE的治疗和预防以及多种其他指征。尽管该药物已被证明是安全有效的,但其在某些指征下的使用尚无经证实的科学证据。为了明确LMWH在孕期除血栓预防之外的作用,需要开展大型前瞻性研究,可基于本研究的结论进行。