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首页> 外文期刊>AJRI: American Journal of Reproductive Immunology >Exploring the Role of Antithrombin Replacement for the Treatment of Preeclampsia: A Prospective Randomized Evaluation of the Safety and Efficacy of Recombinant Antithrombin in Very Preterm Preeclampsia (PRESERVE-1)
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Exploring the Role of Antithrombin Replacement for the Treatment of Preeclampsia: A Prospective Randomized Evaluation of the Safety and Efficacy of Recombinant Antithrombin in Very Preterm Preeclampsia (PRESERVE-1)

机译:探索抗凝血酶替代疗法在先兆子痫中的作用:前瞻性随机评估重组抗凝血酶在早产先兆子痫中的安全性和有效性(PRESERVE-1)

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摘要

Problem: Antithrombin (AT) replacement has been described in patients with hereditary AT deficiency undergoing delivery; however, the kinetics of AT replacement in preeclampsia is not adequately understood. Therefore, the Prospective Randomized Evaluation of the Safety and Efficacy of Recombinant Antithrombin in Very Preterm Preeclampsia (PRESERVE-1) study has been proposed. Methods: Sixty women aged ≥18 years at 24 0/7-28 0/7 weeks' gestation and with hypertension and proteinuria will be enrolled and randomly assigned to receive recombinant human AT or placebo until fetal and/or maternal indications cause cessation of expectant management or until 34 0/7 weeks' gestation. The primary endpoint is the increase in gestational age from randomization to delivery. Safety assessments and laboratory assays will also be performed. Results: PRESERVE-1 study enrollment will begin during the second half of 2013. Conclusion: The PRESERVE-1 study will provide further insight into the pharmacokinetic activity and safety of AT therapy in preeclampsia.
机译:问题:遗传性AT缺乏症患者在分娩时已描述了抗凝血酶(AT)替代治疗;然而,对子痫前期AT替代的动力学还没有充分了解。因此,已经提出了在非常早产子痫前期中对重组抗凝血酶的安全性和有效性进行前瞻性随机评估(PRESERVE-1)的研究。方法:招募60名年龄≥18岁,妊娠24 0 / 7-28 0/7周且患有高血压和蛋白尿的妇女,并随机分配接受重组人AT或安慰剂治疗,直到胎儿和/或母体适应症导致孕妇停止妊娠管理或直到34 0/7周妊娠。主要终点是从随机分组到分娩的胎龄增加。安全评估和实验室测定也将进行。结果:PRESERVE-1研究将于2013年下半年开始。结论:PRESERVE-1研究将为子痫前期AT疗法的药代动力学活性和安全性提供进一步的见识。

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