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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。
Objectives To evaluate the efficacy and safety of anticoagulants (such as aspirin and heparin) in the treatment of two spontaneous abortions or a recent intrauterine fetal death of unknown cause (non-genetic thrombophilia). METHODS We searched the Cochrane Pregnancy and Childbirth Group Clinical Trials Registry (March 2004), the Cochrane Central Register of Controlled Cochrane Library (Cochrane Library 2004 issue 1), MEDLINE (1966.1-2004.3) and EMBASE (1980-2004.3 ). We reviewed all the references that retrieved the study to avoid undetected. A randomized or quasi-randomized clinical trial evaluating the effect of anticoagulant therapy in improving live births was included in women with a history of two spontaneous abortions or a recent unexplained fetal (non-hereditary thrombophilia) fetal womb. Interventions included aspirin for preventing miscarriage, unfractionated heparin and LMWH, compared with placebo or compared with each other. Two authors evaluated the quality of the literature and extracted the data. The data were entered into RevMan and cross-checked. Results A total of two trials (242 patients) were included and data were extracted from subgroups of women who met the inclusion criteria for the evaluation. In one trial, 54 pregnant women with recurrent spontaneous abortion with anti-cardiolipin antibodies were randomized to low-dose aspirin and placebo, with similar rates of live birth (RR = 1.00, 95% CI · 78, 1.29)]. In another trial, 20 women with a previous thrombotic defect in a history of miscarriage after 20 weeks of gestation were randomly assigned to enoxaparin and aspirin groups. Compared with low-dose aspirin treatment, enoxaparin treatment increased live birth rate [RR = 10.0, 95% CI (1.56, 64.20)]. Conclusions There is insufficient evidence of the effectiveness and safety of aspirin and heparin in the treatment of abortions in these women and that anticoagulant therapy is not recommended under current conditions. A large randomized, placebo-controlled trial is urgently needed.