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中剂量依诺肝素预防血管高危妊娠的血栓栓塞症- PACER-VARP 注册研究。

Prophylactic Anticoagulation With Intermediate-Dose Certoparin in Vascular-Risk Pregnancies-The PACER-VARP Registry.

机构信息

Department of Medicine I, Klinikum Heidenheim, Heidenheim, Germany.

Medical Department, Aspen Germany, Munich, Germany.

出版信息

Clin Appl Thromb Hemost. 2021 Jan-Dec;27:10760296211016550. doi: 10.1177/10760296211016550.

Abstract

The management of pregnant women at increased risk of thromboembolic/other vascular events is still a matter of debate. In a single-center, retrospective, observational trial, we analyzed the safety and efficacy of prophylactic anticoagulation with certoparin in pregnant women at intermediate- or high-risk by EThIG criteria of thromboembolic/other vascular events. Subcutaneous certoparin 8,000 IU once daily was administered immediately after pregnancy confirmation and continued for 6 weeks postpartum. We investigated 74 pregnancies (49 women; mean age 31.8 years; weight 77.3 kg). Most prevalent risk factors were factor V Leiden mutation (40.5%), thrombogenic factor II mutation (12.2%) and protein S deficiency (8.1%). In 76 control pregnancies prior to registry inclusion/without anticoagulation there were 14 cases [18.4%] of venous thromboembolism (between week 7 gestation and week 8 postpartum); 63.2% pregnancies resulted in abortion (median week 8.6 gestation). With certoparin anticoagulation, thromboembolism was 1.4%, exclusively non-major bleeding was 4.1% and abortion was 10.8%. One case of pre-eclampsia necessitating obstetric intervention occurred. Prophylactic anticoagulation with intermediate-dose certoparin throughout pregnancies at increased venous vascular risk was safe and effective.

摘要

对于存在血栓栓塞/其他血管事件高危风险的孕妇的管理仍然存在争议。在一项单中心、回顾性、观察性试验中,我们根据血栓栓塞/其他血管事件的 EThIG 标准,分析了中等或高度风险的孕妇预防性使用依诺肝素抗凝的安全性和有效性。皮下注射依诺肝素 8000IU,每日一次,在确认妊娠后立即给药,并持续至产后 6 周。我们调查了 74 例妊娠(49 例女性;平均年龄 31.8 岁;体重 77.3kg)。最常见的危险因素是因子 V Leiden 突变(40.5%)、血栓形成因子 II 突变(12.2%)和蛋白 S 缺乏(8.1%)。在登记/未抗凝的 76 例对照妊娠中,有 14 例(18.4%)发生静脉血栓栓塞(妊娠第 7 周至产后第 8 周);63.2%的妊娠导致流产(中位妊娠第 8.6 周)。使用依诺肝素抗凝时,血栓栓塞的发生率为 1.4%,非大出血的发生率为 4.1%,流产的发生率为 10.8%。有 1 例子痫前期病例需要产科干预。在静脉血管风险增加的孕妇中,整个孕期使用中等剂量依诺肝素进行预防性抗凝是安全有效的。

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