Arch Gynecol Obstet. 2012 Apr;285(4):1055-8. doi: 10.1007/s00404-011-2110-8. Epub 2011 Oct 19.
To evaluate the efficacy and safety of mifepristone and buccal misoprostol versus buccal misoprostol alone in medical abortion of ≤56 days.
One hundred pregnant women having gestational age ≤56 days were randomized to group A and group B. In group A, patients received 200 mg mifepristone on day 1, followed by buccal misoprostol 800 µg on day 2, and in group B patients received 800 µg buccal misoprostol only on day 1.
Complete abortion was the principal outcome measure. Secondary outcome measures were side-effects and acceptability.
Forty-six (92%) patients in group A and 37 (74%) patients in group B aborted successfully (p value 0.017). Four (8%) patients in group A and eight (16%) patients in group B had incomplete abortion with retained products of conception. In group B, three (6%) patients had missed abortion and two (4%) patients had continued pregnancy whereas none of the patients in group A had missed abortion or continued pregnancy. The overall method acceptance was 100% whereas the overall route acceptance was 83%.
Misoprostol-alone regimen is a low-cost regimen as compared to mifepristone/misoprostol regimen. Though the efficacy of mifepristone followed by buccal misoprostol is better, buccal misoprostol alone can be used for termination of pregnancy in patients where mifepristone is either unavailable or contraindicated.
评估米非司酮联合口腔米索前列醇与单纯口腔米索前列醇用于≤56 天药物流产的疗效和安全性。
将 100 名妊娠≤56 天的孕妇随机分为 A 组和 B 组。A 组患者第 1 天口服米非司酮 200mg,第 2 天口服口腔米索前列醇 800μg;B 组患者第 1 天仅口服口腔米索前列醇 800μg。
完全流产是主要观察指标。次要观察指标为副作用和可接受性。
A 组 46 例(92%)和 B 组 37 例(74%)患者流产成功(p 值 0.017)。A 组有 4 例(8%)和 B 组有 8 例(16%)患者发生不完全流产伴妊娠组织残留。B 组有 3 例(6%)患者发生稽留流产和 2 例(4%)患者继续妊娠,而 A 组无患者发生稽留流产或继续妊娠。总的方法接受率为 100%,总的途径接受率为 83%。
与米非司酮/米索前列醇方案相比,米索前列醇单独方案的成本更低。虽然米非司酮序贯口腔米索前列醇的疗效更好,但在米非司酮不可用或禁忌的情况下,也可以单独使用口腔米索前列醇终止妊娠。