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目的评价采用抗凝剂(如阿司匹林和肝素)治疗有两次自然流产史或一次近期不明原因(非遗传性血栓形成倾向)宫内胎死妇女的有效性和安全性.方法我们检索了Cochrane妊娠和分娩组临床试验注册库(2004年3月),Cochrane临床对照试验中心注册库(Cochrane图书馆2004年第1期), MEDLINE(1966.1～2004.3)及EMBASE(1980～2004.3). 我们查阅了所有检索到研究的参考文献以避免漏检.纳入对有两次自然流产史或一次近期不明原因(非遗传性血栓形成倾向)宫内胎死妇女,评估抗凝制剂治疗提高活产率效果的随机或半随机临床对照试验.干预措施包括用于预防流产的阿司匹林、未分馏肝素及低分子肝素,与安慰剂比较或互相比较.由两名作者进行文献质量评价和数据提取,数据录入RevMan并交叉核对.结果共纳入两个试验(242例患者)并均对符合评价纳入标准的妇女亚组进行了数据提取.1个试验中,54例抗心肌磷脂抗体阴性的复发性自然流产妊娠妇女随机分入低剂量阿司匹林治疗组和安慰剂组,两组活产率相似[RR=1.00, 95%CI (0.78,1.29)].另一个试验中,一个之前曾有孕20周后流产史的血栓缺陷妇女亚组共20例,随机分入依诺肝素组和阿司匹林组.与低剂量阿司匹林治疗比较,依诺肝素治疗能提高活产率[RR=10.00, 95%CI (1.56,64.20)].结论现有关于使用阿司匹林和肝素治疗该类妇女流产的有效性和安全性证据不足,现有条件下不推荐使用抗凝剂治疗.急需进行大样本安慰剂对照的随机试验.“,”Objective To evaluate the efficacy and safety of anticoagulant agents, such as aspirin and heparin, in women with a history of at least two spontaneous miscarriages or one later intrauterine fetal death without apparent causes other than inherited thrombophilias. Methods We searched the Cochrane Pregnancy and Childbirth Group trials register (March 2004), the Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2004), MEDLINE (January 1966 to March 2004), and EMBASE (1980 to March 2004). We scanned bibliographies of all located articles for any unidentified articles. Randomised and quasi-randomised controlled trials that assessed the effect of anticoagulant treatment on the live-birth rate in women with a history of at least two spontaneous miscarriages or one later intrauterine fetal death without apparent causes other than inherited thrombophilias were eligible. Interventions included aspirin, unfractionated heparin, and low molecular weight heparin for the prevention of birth loss. One treatment could be compared with another or with placebo. Two authors assessed the trials for inclusion in the review and extracted the data. Data were entered into the Review Manager software and double checked. Results Two studies (242 participants) were included in the review and for both of them data were extracted for the subgroups of women fulfiling the inclusion criteria of the review. In one study, 54 pregnant women with recurrent spontaneous abortion without detectable anticardiolipin antibodies were randomised to low-dose aspirin or placebo. Similar live-birth rates were observed with aspirin and placebo [relative risk (RR) 1.00, 95% confidence interval (CI) 0.78 to 1.29]. In another study, a subgroup of 20 women who had had a previous fetal loss after the 20th week and had a thrombophilic defect were randomised to enoxaparin or aspirin. Enoxaparin treatment resulted in an increased live-birth rate, as compared to low-dose aspirin, RR 10.00, 95% CI 1.56 to 64.20). Conclusions The evidence on the efficacy and safety of thromboprophylaxis with aspirin and heparin in women with a history of at least two spontaneous miscarriages or one later intrauterine fetal death without apparent causes other than inherited thrombophilias is too limited to recommend the use of anticoagulants in this setting. Large, randomised, placebo-controlled trials are urgently needed.