Giacalone P L, Targosz V, Laffargue F, Boog G, Faure J M
Department of Obstetrics and Gynecology, Hôpital Arnaud de Villeneuve, Montpellier, France.
Obstet Gynecol. 1998 Oct;92(4 Pt 1):487-92. doi: 10.1016/s0029-7844(98)00225-7.
To determine the efficacy and safety of mifepristone for cervical ripening in post-term pregnancies.
Women with post-term pregnancies and Bishop scores less than 6 were assigned randomly to mifepristone (41 patients) or placebo (42 patients). Mifepristone was given orally in a dose of 400 mg. Efficacy was assessed by change in the Bishop score within 48 hours after treatment; a score of 6 or greater was considered a "strict" success. An "extended" success rate was defined, including all patients with scores of at least 6 or those who delivered within 48 hours of treatment. Antenatal safety was assessed by fetal heart rate testing before and throughout labor. Neonatal safety was assessed by Apgar score, arterial or venous pH of cord blood, and blood glucose level during the first 48 hours. Analysis used Student t test for continuous variables, Kruskal-Wallis test for ordinal data, and chi2 for categoric variables.
Strict success was achieved in 10 of 18 mifepristone patients (55%) evaluated for Bishop score on day 2 versus 8 of 29 placebo patients (27.5%) (P=.004). Extended success was achieved in 33 mifepristone patients (80.5%) and 21 placebo patients (50.0%) (P=.004). There were no statistical differences with regard to number of cesareans or fetal and neonatal safety.
Mifepristone proved effective for cervical ripening and reduced the time to delivery compared with placebo, but it did not improve the rate of cesarean. Our study did not include enough pregnancies to reach conclusions about fetal or neonatal safety.
确定米非司酮用于过期妊娠促宫颈成熟的有效性和安全性。
将过期妊娠且 Bishop 评分小于 6 的妇女随机分为米非司酮组（41 例）和安慰剂组（42 例）。米非司酮口服剂量为 400 mg。通过治疗后 48 小时内 Bishop 评分的变化评估有效性；评分达到 6 分或更高被视为“严格”成功。定义了“扩展”成功率，包括所有评分至少为 6 分或在治疗后 48 小时内分娩的患者。通过分娩前及分娩过程中的胎心监测评估产前安全性。通过 Apgar 评分、脐血动脉或静脉血 pH 值以及出生后 48 小时内的血糖水平评估新生儿安全性。连续变量分析采用 Student t 检验，有序数据采用 Kruskal-Wallis 检验，分类变量采用 chi2 检验。
在第 2 天评估 Bishop 评分的 18 例米非司酮组患者中，10 例（55%）取得严格成功，而 29 例安慰剂组患者中为 8 例（27.5%）（P = 0.004）。米非司酮组 33 例（80.5%）和安慰剂组 21 例（50.0%）取得扩展成功（P = 0.004）。剖宫产数量以及胎儿和新生儿安全性方面无统计学差异。
与安慰剂相比，米非司酮在促宫颈成熟方面有效，并缩短了分娩时间，但未提高剖宫产率。我们的研究纳入的妊娠病例数不足以得出关于胎儿或新生儿安全性的结论。
