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低分子量肝素治疗反复体外受精-胚胎移植失败及血栓形成倾向:一项前瞻性随机安慰剂对照试验。

Low-molecular-weight heparin in the treatment of recurrent IVF-ET failure and thrombophilia: a prospective randomized placebo-controlled trial.

作者信息

Qublan H, Amarin Z, Dabbas M, Farraj A-E, Beni-Merei Z, Al-Akash H, Bdoor A-N, Nawasreh M, Malkawi S, Diab F, Al-Ahmad N, Balawneh M, Abu-Salim A

机构信息

Infertility & IVF Center, King Hussein Medical Center, Amman, Jordan.

出版信息

Hum Fertil (Camb). 2008 Dec;11(4):246-53. doi: 10.1080/14647270801995431.

Abstract

INTRODUCTION

Recently, thrombophilia (acquired and inherited) has been implicated in recurrent IVF-ET failure. The objective of this study was to determine the effect and safety of thromboprophylaxis using low-molecular-weight heparin (LMWH) in women with recurrent in vitro fertilization (IVF)-embryo transfer (ET) failure and thrombophilia.

METHODS

Eighty-three women with history of three or more previous IVF failures and who had at least one thrombophilic defect were eligible for this study. Patients were randomly allocated into two groups: Group A (n = 42) received enoxaparin 40 mg/day, and group B (n = 41) received placebo (NaCl 0.9%). Both treatments started on the day of ET and continued until delivery or foetal demise was diagnosed. The primary outcomes were the implantation, pregnancy and live birth rates.

RESULTS

Patients who received LMWH for thromboprophylaxis had a significant increase in the implantation and pregnancy rates compared with the placebo group (20.9% vs. 6.1% and 31% vs. 9.6%, respectively; p < 0.001 and p < 0.05, respectively). A significant increase in the live birth rate was observed in the heparin-treated group compared with placebo (23.8% vs. 2.8%, respectively; p < 0.05). The abortion rate was significantly higher in the placebo-treated group compared to the heparin-treated group (p < 0.05). The frequency of treatment complications did not differ between the two study groups.

CONCLUSIONS

LMWH is a safe and effective thromboprophylactic treatment for women with thrombophilia and recurrent IVF-ET failures. The implantation rate, pregnancy and live birth rates are significantly increased with such treatment.

摘要

引言

最近,血栓形成倾向(获得性和遗传性)被认为与反复体外受精-胚胎移植(IVF-ET)失败有关。本研究的目的是确定使用低分子量肝素(LMWH)进行血栓预防对反复体外受精(IVF)-胚胎移植(ET)失败且有血栓形成倾向的女性的疗效和安全性。

方法

83名有三次或更多次既往IVF失败史且至少有一项血栓形成倾向缺陷的女性符合本研究条件。患者被随机分为两组:A组(n = 42)接受依诺肝素40 mg/天,B组(n = 41)接受安慰剂(0.9%氯化钠)。两种治疗均在ET当天开始,并持续至诊断出分娩或胎儿死亡。主要结局指标为着床率、妊娠率和活产率。

结果

与安慰剂组相比,接受LMWH进行血栓预防的患者着床率和妊娠率显著提高(分别为20.9%对6.1%和31%对9.6%;p分别<0.001和p<0.05)。与安慰剂相比,肝素治疗组的活产率显著提高(分别为23.8%对2.8%;p<0.05)。安慰剂治疗组的流产率显著高于肝素治疗组(p<0.05)。两个研究组之间治疗并发症的发生率没有差异。

结论

LMWH是一种对有血栓形成倾向且反复IVF-ET失败的女性安全有效的血栓预防治疗方法。这种治疗可显著提高着床率、妊娠率和活产率。

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