Low Molecular Weight Heparin and Aspirin for Recurrent Pregnancy Loss: Results from the Randomized, Controlled HepASA Trial
Low Molecular Weight Heparin and Aspirin for Recurrent Pregnancy Loss: Results from the Randomized, Controlled HepASA Trial
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DOI：
10.3899/jrheum.080763
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发表时间：
2009-02-01
影响因子：
3.9
通讯作者：
Gent, Michael
中科院分区：
文献类型：
--
作者：
Laskin, Carl. A.;Spitzer, Karen A.;Gent, Michael
Objective.比较复发性妊娠丢失（RPL）和自身抗体或凝血功能异常的妇女，用低分子量肝素加阿司匹林（LMWH/阿萨）或阿萨单药治疗的活产率，并将我们的结果与其他具有类似队列的随机临床试验（RCT）进行比较。HepASA试验是一项随机对照试验，包括具有RPL病史和至少以下1种情况的患者：抗磷脂抗体（aPL）、遗传性血栓形成倾向或抗核抗体。根据aPL状态和早期与晚期妊娠丢失史对治疗组进行分层。患者接受LMWH/阿萨或阿萨单药治疗。主要结局是活产;次要结局包括不良事件和脊柱和股骨颈骨丢失。回顾过去20年的文献，以确定可比的RCT。在4年的时间里，对859名患有RPL的女性进行了筛查：88名（10.2%）符合入选标准，怀孕并随机接受LMWH/阿萨或阿萨单药治疗。aPL在两组中各有42例（47.7%）。4年后，当中期分析显示两组的活产故事没有差异，且仅阿萨组的妊娠丢失率低于预期时，试验停止。在LMWH/阿萨组中，35/45（77.8%）例活产，而仅阿萨组为34/43（79.1%）例（p = 0.71）。既往流产次数和aPL状态均与妊娠结局无关。两组均无妊娠相关血栓形成病例。腰椎（p = 0.57）或股骨颈（p = 0.15）BMD的平均变化在治疗组间无差异。自2000年以来，对aPL阳性的RPL和类似纳入标准的妇女进行的RCT报告，LMWH或ASA的平均活产率为75%。对于该人群，与ASA单药治疗相比，LMWH/阿萨并未增加获益。不考虑治疗方案、既往流产次数或aPL阳性，我们的RPL队列中几乎80%的女性有：成功的妊娠结局。这些发现有助于越来越多的文献质疑包括LMWH/阿萨在内的新兴护理标准。（2009年2月1日首次发布; J Rheumol 2009;36：279-87; doi：10.3899/jrheum.080763）
Objective. To compare live birth rates in women with recurrent pregnancy loss (RPL) and either autoantibodies or a coagulation abnormality, treated with low molecular weight heparin plus aspirin (LMWH/ASA) or ASA alone, and to place our results in context with other randomized clinical trials (RCT) with similar cohorts.Methods. The HepASA Trial was an RCT including patients with a history of RPL and at least 1 of the following: antiphospholipid antibody (aPL), an inherited thrombophilia, or antinuclear antibody. Treatment groups were stratified by aPL status and history of early versus late pregnancy losses. Patients received either LMWH/ASA or ASA alone. The primary outcome was live birth; secondary outcomes included adverse events and bone loss at the spine and femoral neck. Literature over the past 20 years was reviewed to identify comparable RCT.Results. Over 4 years, 859 women with RPL were screened: 88 (10.2%) fulfilled inclusion criteria, became pregnant and were randomized to receive either LMWH/ASA or ASA alone. aPL were present in 42 (47.7%) patients ill each group. The trial was stopped after 4 years when an interim analysis showed no difference in live birth Tales in the 2 groups, and a lower rate of pregnancy loss in the ASA only group than expected, In the LMWH/ASA group, 35/45 (77.8%) had a live birth versus 34/43 (79.1%) in the ASA only group (p = 0.71). Neither number of prior losses nor aPL status was correlated with pregnancy outcome. There were no cases of pregnancy related thrombosis in either group. Mean change in BMD did not differ by treatment group at either the lumbar spine (p = 0.57) or femoral neck (p = 0.15). RCT since 2000 for aPL positive women with RPL and similar inclusion criteria report a mean live birth rate of 75% with either LMWH or ASA.Conclusion. LMWH/ASA did not confer incremental benefit compared to ASA alone for this population. Regardless of treatment regimen, number of prior losses, or aPL positivity, almost 80% of women in our RPL cohort had :a successful pregnancy outcome. These findings contribute to a growing body of literature that contests the emerging standard of care comprising LMWH/ASA for this population. (First Release Feb 1 2009; J Rheumatol 2009;36:279-87; doi: 10.3899/jrheum.080763)