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背景孕前服用低剂量阿司匹林或许对妊娠结果起正性作用,但临床尚未对此做出充分的评价。本研究对低剂量阿司匹林能否提高有1~2次流产史妇女的活产率进行了调查。方法采用多中心、随机区组、双盲、安慰剂对照研究,将美国4个医疗中心18~40岁有妊娠意向的妇女纳入研究。入选标准:最初分组,受试者仅限于近1年内曾有过妊娠<20周流产1次的妇女;扩展分组,扩展至有1~2次流产史的妇女;对孕周及流产时间无限制。受试女性以1∶1的比例按照中心及入选标准进行随机区组化设计。将孕前每日服用低剂量阿司匹林(81 mg/d)+叶酸组与安慰剂+叶酸组进行对照,共治疗6个月经周期;对已妊娠妇女,治疗持续至妊娠36周。受试者、试验人员和调查者对所设计的治疗一无所知。主要结果为活产率,并对其进行治疗意向分析。结果 2007-06-15至2011-07-15,共纳入1 228例妇女,其中1 078例完成了调查,并被纳入分析(低剂量阿司匹林组535例、安慰剂组543例);低剂量阿司匹林组中有309例(58%)活产儿,安慰剂组有268例(53%)活产儿〔P=0.0984,活产率绝对差异=5.09%,95%CI(-0.84,11.02)〕。低剂量阿司匹林组中有68例(13%)发生流产,安慰剂组为65例(12%)(P=0.7812)。按照最初分组,低剂量阿司匹林组242例妇女中有151例(62%)活产儿,安慰剂组250例妇女中有133例(53%)〔P=0.0446,活产率的绝对差异=9.20%,95%CI(0.51,17.89)〕。按照扩展分组,低剂量阿司匹林组293例妇女中有158例(54%)活产儿,安慰剂组293例妇女中有153例(52%)活产儿〔P=0.7406,活产率的绝对差异=1.71%,95%CI(-6.37,9.79)〕。两组主要不良反应事件发生率相似。低剂量阿司匹林与阴道出血增加相关,但与流产无关。结论有1~2次流产史的妇女孕前服用低剂量阿司匹林与活产或流产无相关性。但近1年内有妊娠<20周流产史妇女的活产率较高。不推荐使用低剂量阿司匹林来预防流产。
Background Low doses of aspirin given before pregnancy may have a positive effect on pregnancy outcomes, but this has not been adequately evaluated clinically. This study investigated whether low-dose aspirin can increase the live birth rates of women who have had 1 to 2 abortions. METHODS: A multicenter, randomized, double-blind, placebo-controlled study was included in a study of pregnant women aged 18-40 who were pregnant at four medical centers in the United States. Inclusion criteria: Initial grouping, subjects were limited to women who had had a 1-year pregnancy <20 weeks of abortion in nearly a year; women who were expanded to groups of 1 to 2 miscarriage history; and no restrictions on gestational age and abortion time . The subjects were randomized to receive a 1: 1 ratio of center and inclusion criteria. A low dose of aspirin (81 mg / d) plus folic acid was administered daily to pregnant women prior to pregnancy for a total of 6 menstrual cycles compared with placebo plus folic acid. Pregnancy was continued in pregnant women up to 36 weeks of gestation. Subjects, testers and investigators knew nothing about the treatment they designed. The main result is live birth rate, and analysis of its intention to treat. Results A total of 1 228 women were enrolled from 2007-06-15 to 2011-07-15, of whom 1,078 were completed and included in the analysis (535 in the low-dose aspirin group and 543 in the placebo group); low-dose aspirin There were 309 (58%) live births in the group and 268 (53%) live births in the placebo group (P = 0.0984, absolute difference in live birth rate = 5.09%, 95% CI, -0.84, 11.02). 68 (13%) miscarriage occurred in the low-dose aspirin group compared with 65 (12%) in the placebo group (P = 0.7812). In the initial subgroup, 151 (62%) of the 242 women in the low-dose aspirin group were alive and 133 (53%) in the placebo group of 250 women [P = 0.0446, absolute difference in live birth rate = 9.20% , 95% CI (0.51, 17.89)]. In the expanded subgroup, 158 (54%) of the 293 women in the low-dose aspirin group were alive and 153 (52%) of the 293 women in the placebo group [P = 0.7406, absolute difference in live birth rate = 1.71%, 95% CI (-6.37, 9.79)]. The incidence of major adverse events in both groups was similar. Low-dose aspirin is associated with increased vaginal bleeding, but not abortion. Conclusion There was no correlation between low-dose aspirin and live birth or miscarriage in women who had 1 or 2 abortion history before pregnancy. However, in the past year, women with a history of miscarriage <20 weeks have a high live birth rate. Low-dose aspirin is not recommended to prevent miscarriage.