Gynuity Health Projects, New York 10012, USA.
Int J Gynaecol Obstet. 2012 Aug;118(2):166-71. doi: 10.1016/j.ijgo.2012.03.039. Epub 2012 Jun 8.
To assess the potential advantages of combined mifepristone-misoprostol versus misoprostol-only for early medical abortion.
A double-blind randomized placebo controlled study was conducted that enrolled 441 pregnant women (<63 days since last menstrual period) at 2 hospitals in Tunisia and Vietnam. The mifepristone-misoprostol group (n=220) received 200mg of mifepristone on day 1 and 800 μg buccal misoprostol followed by placebo 3 hours later on day 2. The misoprostol-only group (n=221) received placebo on day 1 and 1600 μg of misoprostol (2 doses of 800 μg, given 3 hours apart) on day 2. All medications were self-administered at home with follow-up 1 week later. The primary outcome was complete uterine evacuation without surgical intervention.
Successful uterine evacuation occurred for 78.0% (n=170) of women with misoprostol only versus 92.9% (n=195) of women with mifepristone-misoprostol (relative risk 0.84, 95% CI, 0.78-0.91; P<0.001). Ongoing pregnancy occurred for 13.8% (n=30) of women given misoprostol-only and 1.4% (n=3) of women given mifepristone-misoprostol (relative risk 9.63, 95% CI 2.98-31.09; P<0.001).
Mifepristone plus misoprostol is significantly more effective than misoprostol-only for early medical abortion.
评估米非司酮-米索前列醇联合用药与单纯米索前列醇用于早孕药物流产的潜在优势。
在突尼斯和越南的 2 家医院进行了一项双盲随机安慰剂对照研究，共纳入 441 名怀孕时间<63 天的孕妇。米非司酮-米索前列醇组（n=220）于第 1 天服用 200mg 米非司酮，第 2 天 800μg 米索前列醇经口腔给药，随后给予安慰剂，3 小时后再次给药；米索前列醇单药组（n=221）于第 1 天给予安慰剂，第 2 天给予 1600μg 米索前列醇（2 次剂量，每次 800μg，间隔 3 小时）。所有药物均在家中自行服用，1 周后进行随访。主要结局为无需手术干预即完全排空子宫。
单纯米索前列醇组完全排空子宫的成功率为 78.0%（n=170），米非司酮-米索前列醇组为 92.9%（n=195）（相对风险 0.84，95%CI，0.78-0.91；P<0.001）。单纯米索前列醇组持续妊娠的发生率为 13.8%（n=30），米非司酮-米索前列醇组为 1.4%（n=3）（相对风险 9.63，95%CI 2.98-31.09；P<0.001）。
米非司酮联合米索前列醇用于早孕药物流产的效果明显优于单纯米索前列醇。
