Efficacy and safety of once daily low molecular weight heparin (tinzaparin sodium) in high risk pregnancy
Efficacy and safety of once daily low molecular weight heparin (tinzaparin sodium) in high risk pregnancy
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DOI：
10.1097/mbc.0b013e32830b14ef
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发表时间：
2008-10-01
影响因子：
1.1
通讯作者：
O'Donnell, James
中科院分区：
文献类型：
--
作者：
Ainle, Fionnuala Ni;Wong, Audris;O'Donnell, James
低分子量肝素（LMWH）被广泛认为是预防和治疗妊娠期静脉血栓栓塞症的首选抗凝治疗。然而，先前的研究表明，LMWH的药代动力学特征随妊娠期的增加而显著变化。因此，目前尚不清楚推荐用于非妊娠个体的LMWH方案是否可以安全地外推至妊娠女性。本研究的目的是评估妊娠期间每日一次给予汀扎肝素钠（Innohep）的安全性和有效性。一项系统性回顾性审查确定了一个包含37例高危妊娠的队列，这些妊娠均使用汀扎肝素175 IU/kg每日一次进行管理。在26例病例中，首次妊娠并发急性静脉血栓栓塞（17例深静脉血栓形成和9例肺栓塞）。对于每个人，病例记录进行了检查，并使用预先确定的调查问卷提取数据。在使用每日一次LMWH给药管理的妊娠队列中，未发现复发性静脉血栓栓塞。然而，观察到两个不寻常的血栓性并发症，包括一个病人的顶叶梗死，和产后脑静脉血栓形成在另一个。每日一次的汀扎肝素耐受性良好，没有肝素诱导的血小板减少症、症状性骨质疏松症或胎儿畸形的病例。在45%的检查病例中，根据抗-XA峰值水平调整了汀扎肝素剂量。目前的研究是最大的研究，已检查的临床疗效，每天一次的低分子肝素用于孕妇在高风险的静脉血栓栓塞。我们的数据支持产前使用175 IU/kg剂量的汀扎肝素的安全性和有效性。为了确定这种每日一次的治疗方案是否能提供与妊娠期间每日两次的LMWH治疗方案相当（甚至更高）的血栓预防作用，需要进行高效力的直接比较研究。血液凝固纤维蛋白溶解19：689-692（C）2008 Wolters Kluwer Health|利平科特威廉姆斯&威尔金斯。
Low molecular weight heparin (LMWH) is widely regarded as the anticoagulant treatment of choice for the prevention and treatment of venous thromboembolism during pregnancy. However, previous studies have demonstrated that the pharmacokinetic profiles of LMWH vary significantly with increasing gestation. Consequently, it remains unclear whether LMWH regimens recommended for use in nonpregnant individuals can be safely extrapolated to pregnant women. The aims of this study were to assess the safety and the efficacy of tinzaparin sodium (Innohep) administered only once daily during pregnancy. A systematic retrospective review identified a cohort of 37 high-risk pregnancies which had been managed using tinzaparin 175 IU/kg once daily. In 26 cases, the index pregnancy had been complicated by development of an acute venous thromboembolism (17 deep vein thrombosis and nine pulmonary embolism). For each individual, case notes were examined and data extracted using a predetermined questionnaire. No episodes of recurrent venous thromboembolism were identified amongst this cohort of pregnancies managed using once daily LMWH administration. However, two unusual thrombotic complications were observed, including a parietal infarct in one patient, and a postpartum cerebral venous thrombosis in another. Once daily tinzaparin was well tolerated, with no cases of heparin-induced thrombocytopaenia, symptomatic osteoporosis, or foetal malformations. Tinzaparin dose modification based upon peak anti-Xa levels occurred in 45% of the cases examined. The present study is the largest study to have examined the clinical efficacy of once daily LMWH for use in pregnant women at high risk of venous thromboembolism. Our data support the safety and efficacy of antenatal tinzaparin at a dose of 175 IU/kg. In order to determine whether this once daily regimen provides equivalent (or indeed greater) thromboprophylaxis to twice daily LMWH regimens during pregnancy will require highly powered direct comparative studies. Blood Coagul Fibrinolysis 19:689-692 (C) 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins.