Shantikumar Usham, Bagga Rashmi, Kalra Jasvinder, Jain Vanita, Suri Vanita, Singh Anju, Choudhary Neelam
Department of Obstetrics and Gynaecology, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012 India.
J Obstet Gynaecol India. 2022 Aug;72(Suppl 1):26-35. doi: 10.1007/s13224-021-01521-x. Epub 2021 Jul 13.
Based upon the pharmacokinetics of mifepristone, we postulated that repeating a dose after its half-life period may potentiate its abortifacient effect.
We administered mifepristone (200 mg) on days one and two, and misoprostol on day three (200 or 400 μg, vaginally, six-hourly, upto three doses in 12 h) in 100 women (intervention group). We compared their outcome with that of another 100 women who received the one-dose mifepristone regimen (mifepristone on day one and misoprostol on day three) during the months immediately preceding the study period (historical controls).
The mean age, parity and gestation (18 weeks) were similar in the two groups. On day three (before initiating misoprostol), cervix admitted one finger in significantly more women in the intervention group (36 versus 8% in historical controls; = 0.001). All women aborted successfully in the two groups. The IAI of the intervention group was significantly shorter than the IAI of historical controls (10.45 vs 13.75 h; = 0.013), and the misoprostol requirement was also significantly lower (mean 434 vs 500 μg among historical controls, = 0.04).
Second-trimester medical abortion using two sequential doses of mifepristone followed by misoprostol reduced the IAI and misoprostol requirement without adding any extra days to the existing regimen. Further randomized studies can assess if the 'two-dose' mifepristone regimen is more efficient than the 'one-dose' regimen.
基于米非司酮的药代动力学,我们推测在其半衰期后重复给药可能会增强其堕胎效果。
我们在100名女性(干预组)中于第1天和第2天给予米非司酮(200毫克),并于第3天给予米索前列醇(200或400微克,经阴道给药,每6小时一次,12小时内最多3剂)。我们将她们的结果与另外100名在研究期前几个月接受单剂量米非司酮方案(第1天给予米非司酮,第3天给予米索前列醇)的女性(历史对照)的结果进行了比较。
两组的平均年龄、产次和孕周(18周)相似。在第3天(开始使用米索前列醇之前),干预组中宫颈可容纳一指的女性明显更多(36%对历史对照中的8%;P = 0.001)。两组所有女性均成功流产。干预组的流产诱导间隔(IAI)明显短于历史对照的IAI(10.45对13.75小时;P = 0.013),米索前列醇的需求量也明显更低(历史对照中平均为434微克对500微克,P = 0.04)。
在孕中期采用两剂序贯米非司酮后接米索前列醇进行药物流产,可缩短IAI并减少米索前列醇的需求量,且未在现有方案基础上增加额外天数。进一步的随机研究可评估“两剂”米非司酮方案是否比“单剂”方案更有效。