Berkane Nadia, Verstraete Lieve, Uzan Serge, Boog Georges, Maria Bernard
Department of Gynecology-Obstetrics and Reproductive Medicine, Hôpital Tenon, Paris, France.
Am J Obstet Gynecol. 2005 Jan;192(1):114-20. doi: 10.1016/j.ajog.2004.05.084.
This study was undertaken to determine the efficacy of mifepristone for ripening the cervix and inducing labor in term pregnancies.
In a double-blind placebo-controlled dose-finding study, 346 women received 50, 100, 200, 400, or 600 mg of mifepristone or placebo. The main endpoint for efficacy was the number of patients in whom labor occurred between 12 and 45 and 54 hours after treatment or who had a Bishop score 6 or greater. Maternal and fetal tolerability was also studied.
No significant efficacy was observed whatever the dose of mifepristone. Mifepristone was well tolerated by the mother and fetus.
Mifepristone, at doses up to 600 mg, does not induce labor within 54 hours in patients with unfavourable cervical status.
本研究旨在确定米非司酮在足月妊娠中促宫颈成熟及引产的疗效。
在一项双盲、安慰剂对照的剂量探索性研究中，346名妇女接受了50、100、200、400或600毫克米非司酮或安慰剂。疗效的主要终点是治疗后12至45小时和54小时内分娩或Bishop评分达到6分或更高的患者数量。还研究了母体和胎儿的耐受性。
无论米非司酮剂量如何，均未观察到显著疗效。母亲和胎儿对米非司酮耐受性良好。
对于宫颈条件不佳的患者，剂量高达600毫克的米非司酮在54小时内不能引产。
