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米非司酮(RU 486)与前列腺素类似物用于自愿终止妊娠。法国的一项大规模经验。

Voluntary interruption of pregnancy with mifepristone (RU 486) and a prostaglandin analogue. A large-scale French experience.

作者信息

Silvestre L, Dubois C, Renault M, Rezvani Y, Baulieu E E, Ulmann A

机构信息

Roussel-UCLAF, Paris, France.

出版信息

N Engl J Med. 1990 Mar 8;322(10):645-8. doi: 10.1056/NEJM199003083221001.

Abstract

In 2115 women seeking voluntary termination of pregnancy after 49 days of amenorrhea or less, we studied the effect of a single 600-mg dose of mifepristone (RU 486), followed 36 to 48 hours later by the administration of one of two prostaglandin analogues, either gemeprost (1 mg by vaginal suppository) or sulprostone (0.25, 0.375, or 0.5 mg by intramuscular injection). The women were monitored for four hours after prostaglandin administration. Efficacy was indicated by the complete expulsion of the conceptus without the need of an additional procedure. All other results were considered failures, and the pregnancy was then terminated by a surgical method. The overall efficacy rate was 96.0 percent (95 percent confidence interval, 95.0 to 96.8). The failures included persisting pregnancies (1.0 percent), incomplete expulsions (2.1 percent), and the need for hemostatic procedure (0.9 percent). The mean time to expulsion was significantly shorter when sulprostone was given in the high dose (4.5 hours) than when it was given in the two lower doses (13.1 and 19.3 hours) or when gemeprost was given (22.7 hours). The mean duration of uterine bleeding was 8.9 days (range, 1 to 35); one woman received a blood transfusion. Most women had transient abdominal pain after receiving prostaglandin, but there were few other side effects. We conclude that the administration of mifepristone followed by a small dose of a prostaglandin analogue is an effective and safe method for the early termination of pregnancy.

摘要

在2115名停经49天及以内寻求自愿终止妊娠的女性中,我们研究了单次服用600毫克米非司酮(RU 486)的效果,36至48小时后再给予两种前列腺素类似物之一,即吉美前列素(经阴道栓剂给予1毫克)或硫前列酮(经肌肉注射给予0.25毫克、0.375毫克或0.5毫克)。在给予前列腺素后对这些女性进行了4小时的监测。妊娠物完全排出且无需额外手术被视为有效。所有其他结果均视为失败,然后通过手术方法终止妊娠。总体有效率为96.0%(95%置信区间为95.0至96.8)。失败情况包括持续妊娠(1.0%)、排出不完全(2.1%)以及需要进行止血手术(0.9%)。硫前列酮高剂量给药时排出的平均时间(4.5小时)明显短于低剂量给药时(13.1小时和19.3小时)或给予吉美前列素时(22.7小时)。子宫出血的平均持续时间为8.9天(范围为1至35天);1名女性接受了输血。大多数女性在接受前列腺素后有短暂的腹痛,但其他副作用很少。我们得出结论,先服用米非司酮再给予小剂量前列腺素类似物是早期终止妊娠的一种有效且安全的方法。

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