PREVENTION OF FETAL GROWTH-RETARDATION WITH LOW-DOSE ASPIRIN - FINDINGS OF THE EPREDA TRIAL
PREVENTION OF FETAL GROWTH-RETARDATION WITH LOW-DOSE ASPIRIN - FINDINGS OF THE EPREDA TRIAL
复制标题
DOI：
10.1016/0140-6736(91)93124-r
复制
发表时间：
1991-06-15
期刊：
影响因子：
168.9
通讯作者：
PARIS, J
中科院分区：
文献类型：
--
作者：
UZAN, S;BEAUFILS, M;PARIS, J
小剂量阿司匹林预防胎儿生长迟缓的有效性在一项随机、安慰剂对照的双盲试验中进行了测试。第二个目的是找出双嘧达莫是否能提高阿司匹林的疗效。根据胎儿发育迟缓和/或胎儿死亡或胎盘早剥，在25个参与中心选出了闭经15-18周的323名妇女，至少有一次怀孕。他们被随机分配到安慰剂、150毫克/天的阿司匹林或150毫克/天的阿司匹林+225毫克/天的潘生丁，用于妊娠剩余时间。在试验的第一阶段，所有积极治疗的患者(n=156)与安慰剂组(n=73)进行比较。治疗组的平均出生体重显著高于安慰剂组(2751vs2526848g；差异225g[95%Cl129-321g]，p=0.029)，安慰剂组胎儿生长迟缓的发生率是安慰剂组的两倍(19[26%]vs20[13%]；p<；0.02)。安慰剂组死产发生率(4[5%]vs 2[1%])和胎盘早剥发生率(6[8%]vs 7[5%])也高于治疗组。阿司匹林治疗的益处在有两次或两次以上不良结果的患者中比只有一次结果差的患者更大。在第二个分析中，单用阿司匹林(n=127)与阿司匹林加潘生丁(n=119)相比，没有发现显著差异。服用阿司匹林的患者没有过量的母体或新生儿副作用。《柳叶刀》91；337：1427-31。
The efficacy of low-dose aspirin in preventing fetal growth retardation was tested in a randomised, placebo-controlled, double-blind trial. A secondary aim was to find out whether dipyridamole improves the efficacy of aspirin. 323 women at 15-18 weeks' amenorrhoea were selected at twenty-five participating centres on the basis of fetal growth retardation and/or fetal death or abruptio placentae in at least one previous pregnancy. They were randomly allocated to groups receiving placebo, 150 mg/day aspirin, or 150 mg/day aspirin plus 225 mg/day dipyridamole, for the remainder of the pregnancy. In the first phase of the trial all actively treated patients (n = 156) were compared with the placebo group (n = 73). Mean birthweight was significantly higher in the treated than in the placebo group (2751 [SD 670] vs 2526 [848] g; difference 225 g [95% Cl 129-321 g], p = 0.029) and the frequency of fetal growth retardation in the placebo group was twice that in the treated group (19 [26%] vs 20 [13%]; p < 0.02). The frequencies of stillbirth (4 [5%] vs 2 [1%]) and abruptio placentae (6 [8%] vs 7 [5%]) were also higher in the placebo than in the treated group. The benefits of aspirin treatment were greater in patients with two or more previous poor outcomes than in those with only one. In the second analysis, of aspirin only (n = 127) vs aspirin plus dipyridamole (n = 119), no significant differences were found. There was no excess of maternal or neonatal side-effects in the aspirin-treated patients. Lancet 1 991; 337: 1427-31.