Pattison N S, Chamley L W, Birdsall M, Zanderigo A M, Liddell H S, McDougall J
Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.
Am J Obstet Gynecol. 2000 Oct;183(4):1008-12. doi: 10.1067/mob.2000.106754.
This pilot investigation was undertaken to assess the efficacy of low-dose aspirin therapy for the treatment of women with antiphospholipid antibodies when recurrent miscarriage is the only sequela.
A double-blind, randomized, placebo-controlled trial was conducted in the setting of the recurrent miscarriage clinic of a tertiary referral obstetric hospital. The participants were 50 women with a history of recurrent miscarriages (>/=3) and antiphospholipid antibodies. Women with systemic lupus erythematosus or a history of thrombosis were excluded. Women were recruited after full investigative screening at the recurrent miscarriage clinic. Women with >/=3 fetal losses and persistently positive results for antiphospholipid antibodies were randomly allocated to receive either aspirin (75 mg daily) or placebo. Investigators, clinicians, and patients were blinded to the treatment. Rates of live births, antenatal complications, and delivery and neonatal outcomes were recorded prospectively. Data were compared by chi(2) analysis with Yates' correction, the Fisher exact test, or the Student t test as appropriate.
There were 10 exclusions after random assignment because of inappropriate inclusion. Eighty-five percent of the placebo (17/20) group and 80% of the aspirin-treated group (16/20) were delivered of live infants. This difference was not significant. There were no significant differences in antenatal complications or neonatal morbidity between the groups.
This preliminary study suggests that low-dose aspirin has no additional benefit when added to supportive care for women for whom recurrent early fetal loss is the only sequela of the antiphospholipid syndrome. This live birth rate with supportive care alone exceeds the published live birth rates for women with antiphospholipid antibody-mediated recurrent fetal loss who were treated with heparin or corticosteroids. This trial, like all other trials in this field, is small, but its results bring into question the need for pharmacologic intervention for women with antiphospholipid syndrome for whom recurrent fetal loss is the only sequela. Our results highlight the need for a large randomized controlled trial to identify the optimal treatment for this group of women and justify the inclusion of a placebo arm in any such trial.
本初步研究旨在评估低剂量阿司匹林疗法对仅以复发性流产为唯一后遗症的抗磷脂抗体女性患者的治疗效果。
在一家三级转诊产科医院的复发性流产诊所进行了一项双盲、随机、安慰剂对照试验。参与者为50名有复发性流产史（≥3次）且存在抗磷脂抗体的女性。排除患有系统性红斑狼疮或有血栓形成史的女性。在复发性流产诊所进行全面检查筛选后招募女性。有≥3次胎儿丢失且抗磷脂抗体持续呈阳性的女性被随机分配接受阿司匹林（每日75毫克）或安慰剂治疗。研究人员、临床医生和患者均对治疗不知情。前瞻性记录活产率、产前并发症以及分娩和新生儿结局。数据根据情况采用经Yates校正的卡方分析、Fisher精确检验或Student t检验进行比较。
随机分组后有10例因纳入不当被排除。安慰剂组（17/20）中有85%以及阿司匹林治疗组（16/20）中有80%分娩出活婴。这一差异不显著。两组之间在产前并发症或新生儿发病率方面无显著差异。
这项初步研究表明，对于复发性早期胎儿丢失是抗磷脂综合征唯一后遗症的女性，在给予支持性护理的基础上加用低剂量阿司匹林并无额外益处。仅通过支持性护理的活产率超过了已发表的接受肝素或皮质类固醇治疗的抗磷脂抗体介导的复发性胎儿丢失女性的活产率。与该领域的所有其他试验一样，本试验规模较小，但其结果让人质疑对于复发性胎儿丢失是唯一后遗症的抗磷脂综合征女性进行药物干预的必要性。我们的结果凸显了开展一项大型随机对照试验以确定该组女性最佳治疗方法的必要性，并证明在任何此类试验中纳入安慰剂组的合理性。
