Department of Medicine, Division of Rheumatology, University Medical Cluster, National University Health System, Yong Loo Lin School of Medicine, Singapore.
Rheumatology (Oxford). 2010 Feb;49(2):281-8. doi: 10.1093/rheumatology/kep373. Epub 2009 Dec 4.
The combination of heparin and aspirin was regarded as the 'standard therapy' for patients with recurrent pregnancy loss (RPL) and positive aPL antibodies to enhance live births, but it largely stems from expert opinion. We performed a meta-analysis of randomized controlled trials (RCTs) to assess whether this combination works better than aspirin alone.
RCTs testing the efficacy of a combination of heparin and aspirin vs aspirin alone in patients with RPL and positive aPL antibodies were identified in electronic databases. Random effect meta-analysis was employed to pool relative risks (RRs) (with 95% CI) of live births as the primary outcome. RRs of obstetrical complications and standardized mean difference of birth weight were the secondary outcomes. Mixed-effects meta-regression was performed to identify factors associated with live births.
Data from five trials involving 334 patients were analysed. The overall live birth rates were 74.27 and 55.83% in the combination and aspirin alone groups, respectively. Patients who received heparin and aspirin had significantly higher live birth rate (RR 1.301; 95% CI 1.040, 1.629) than aspirin alone, with the number needed to achieve one live birth being 5.6. No significant differences in pre-eclampsia, preterm labour and birth weight were found between both the groups. Meta-regression using age at randomization, previous history of live births and episodes of miscarriages as covariates failed to predict the RR of live birth.
The combination of heparin and aspirin is superior to aspirin alone in achieving more live births in patients with positive aPL antibodies and RPL.
肝素和阿司匹林的联合应用被视为复发性妊娠丢失（RPL）和抗磷脂抗体阳性患者的“标准治疗”，以提高活产率，但主要源于专家意见。我们对随机对照试验（RCT）进行了荟萃分析，以评估这种联合治疗是否优于单独使用阿司匹林。
在电子数据库中确定了评估肝素和阿司匹林联合治疗与单独使用阿司匹林治疗 RPL 和抗磷脂抗体阳性患者疗效的 RCT。采用随机效应荟萃分析汇总活产率（主要结局）的相对风险（RR）（95%置信区间）。产科并发症的 RR 和出生体重的标准化均数差为次要结局。采用混合效应荟萃回归分析确定与活产相关的因素。
对 5 项涉及 334 例患者的试验进行了数据分析。联合治疗组和单独使用阿司匹林组的总体活产率分别为 74.27%和 55.83%。接受肝素和阿司匹林治疗的患者活产率显著更高（RR 1.301；95%CI 1.040，1.629），需要治疗的人数为 5.6。两组间子痫前期、早产和出生体重无显著差异。使用随机分组时的年龄、既往活产史和流产史作为协变量进行荟萃回归，未能预测活产率的 RR。
在抗磷脂抗体阳性和 RPL 患者中，肝素和阿司匹林联合应用优于单独使用阿司匹林，可提高活产率。
