Spitz I M, Bardin C W, Benton L, Robbins A
Center for Biomedical Research, Population Council, New York, NY 10021, USA.
N Engl J Med. 1998 Apr 30;338(18):1241-7. doi: 10.1056/NEJM199804303381801.
Mifepristone and a prostaglandin have been used successfully to terminate pregnancy in Europe and China. We report the results of a large U.S. study of mifepristone and misoprostol in women with pregnancies of up to nine weeks' duration.
We administered 600 mg of mifepristone and then 400 microg of misoprostol two days later to 2121 women seeking termination of their pregnancies at 17 centers. The women were observed for four hours after the administration of misoprostol and returned on day 15 for final assessment.
Two thousand fifteen women completed the final assessment. Among them, pregnancy was terminated in 762 of the 827 women pregnant for < or =49 days (92 percent), 563 of the 678 women pregnant for 50 to 56 days (83 percent), and 395 of the 510 women pregnant for 57 to 63 days (77 percent) (P<0.001). Termination occurred within 4 hours after the administration of misoprostol in 49 percent of the women and within 24 hours in 75 percent. Failures, defined as cases requiring surgical intervention for medical reasons or because the patient requested it, the abortion was incomplete, or the pregnancy was ongoing, increased with increasing duration of pregnancy. The largest increase was in failures representing ongoing pregnancy, which increased from 1 percent in the < or =49-days group to 9 percent in the 57-to-63-days group (P<0.001). Abdominal pain, nausea, vomiting, diarrhea, and vaginal bleeding also increased with advancing gestational age. Two percent of the women in the < or =49-days group, as compared with 4 percent in each of the other two groups, were hospitalized, underwent surgical interventions, and received intravenous fluids (P=0.008).
This mifepristone-misoprostol regimen is effective in terminating pregnancies, especially in women with pregnancies of 49 days' duration or less.
米非司酮和一种前列腺素已在欧洲和中国成功用于终止妊娠。我们报告了一项针对美国大量怀孕9周及以内女性使用米非司酮和米索前列醇的研究结果。
我们在17个中心为2121名寻求终止妊娠的女性给予600毫克米非司酮，然后在两天后给予400微克米索前列醇。在给予米索前列醇后对这些女性观察4小时，并在第15天返回进行最终评估。
2015名女性完成了最终评估。其中，怀孕≤49天的827名女性中有762名终止了妊娠（92%），怀孕50至56天的678名女性中有563名（83%），怀孕57至63天的510名女性中有395名（77%）（P<0.001）。49%的女性在给予米索前列醇后4小时内终止妊娠，75%的女性在24小时内终止妊娠。失败定义为因医学原因或患者要求而需要手术干预、流产不完全或妊娠仍在继续的情况，其随着妊娠时间延长而增加。妊娠仍在继续导致的失败增加最为明显，从≤49天组的1%增加到57至63天组的9%（P<0.001）。腹痛、恶心、呕吐、腹泻和阴道出血也随着孕周增加而增加。≤49天组有2%的女性住院、接受了手术干预并接受了静脉输液，另外两组的这一比例均为4%（P=0.008）。
这种米非司酮-米索前列醇方案在终止妊娠方面有效，尤其是对于妊娠49天及以内的女性。
