米非司酮序贯米索前列醇或缩宫素用于中期妊娠流产：一项随机对照试验。

Mifepristone followed by misoprostol or oxytocin for second-trimester abortion: a randomized controlled trial.

机构信息

Departments of Obstetrics and Gynecology and Nursing Administration, the Hadassah Ein-Kerem Medical Centers, the Hebrew University Medical School, Jerusalem, Israel.

出版信息

Obstet Gynecol. 2013 Oct;122(4):815-820. doi: 10.1097/AOG.0b013e3182a2dcb7.

DOI:10.1097/AOG.0b013e3182a2dcb7

PMID:24084539

Abstract

OBJECTIVE

To compare two methods for induction of second-trimester abortion after priming the cervix with mifepristone.

METHODS

This was a randomized prospective trial carried out between January 2009 and February 2012. The participants were healthy women between 14 and 24 weeks of gestation with missed miscarriage or need for termination of pregnancy. All participants received oral 200 mg mifepristone and, after 36 hours, after randomization, were given either a high-concentration oxytocin drip (maximal dose of 150 milli-international units/min) for up to 36 hours or 800 micrograms misoprostol vaginally followed by 400 micrograms oral misoprostol every 3 hours with a maximum of four oral doses. If expulsion of the fetus was not achieved, another 200 mg mifepristone was administered and another course of misoprostol was delivered as described previously. The primary outcome measure was success expulsion of the fetus in 36 hours since starting on uterotonic agent. Secondary outcomes included time until expulsion of the fetus and rate of adverse outcomes.

RESULTS

Success rates in the mifepristone-misoprostol and mifepristone-oxytocin arms were 100% (70/70 patients) and 95.8% (69/72), respectively (relative risk 1.043, 95% confidence interval 0.99-1.10, P=.13). Time until fetal expulsion was shorter in the mifepristone-misoprostol arm (7.0 ± 4.9 hours compared with 11.3 ± 7.4 hours, P<.001). However, the rate of adverse effects in the misoprostol group was higher than in the oxytocin group. Factors associated with a shorter time until expulsion were missed miscarriage compared with therapeutic abortion, increased ultrasonographic gestational age, and increased parity.

CONCLUSION

The two regimens studied had comparable efficacy for induction of second-trimester abortion; however, the mifepristone-oxytocin regimen has a longer time until expulsion but with fewer side effects.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, www.clinicaltrials.gov, NCT00784797.

LEVEL OF EVIDENCE

: I.

摘要

目的

比较米非司酮预处理宫颈后两种方法用于诱导中期妊娠流产的效果。

方法

这是一项于 2009 年 1 月至 2012 年 2 月期间进行的随机前瞻性试验。参与者为孕 14-24 周、有过期流产或需要终止妊娠的健康女性。所有参与者均口服 200mg 米非司酮，36 小时后随机分组，一组给予高浓度催产素滴注（最大剂量 150 毫国际单位/分钟），持续 36 小时，另一组给予 800μg 米索前列醇阴道给药，然后每 3 小时给予 400μg 口服米索前列醇，最多 4 次口服剂量。如果未能排出胎儿，再给予 200mg 米非司酮，并给予上述米索前列醇。主要结局测量指标为开始使用缩宫剂后 36 小时内胎儿排出的成功率。次要结局包括排出胎儿的时间和不良结局的发生率。

结果

米非司酮-米索前列醇组和米非司酮-催产素组的成功率分别为 100%（70/70 例）和 95.8%（69/72 例）（相对风险 1.043，95%置信区间 0.99-1.10，P=.13）。米非司酮-米索前列醇组胎儿排出时间更短（7.0±4.9 小时比 11.3±7.4 小时，P<.001）。然而，米索前列醇组的不良反应发生率高于催产素组。与引产相比，过期流产、超声孕周增加和产次增加与排出时间缩短相关。