Fox Michelle C, Creinin Mitchell D, Harwood Bryna
Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine and Magee-Womens Research Institute, Pittsburgh, PA, USA.
Contraception. 2002 Oct;66(4):225-9. doi: 10.1016/s0010-7824(02)00358-x.
In a previous study of 40 women up to 49 days' gestation, our research center demonstrated that mifepristone 200 mg followed on the same day by misoprostol 800 microg vaginally produced abortion at rates similar to standard regimens which administer the two drugs 24 or 48 h apart. We performed this study to evaluate the same regimen in women with pregnancies at 50 to 63 days' gestation. Forty women from 50 to 56 days' gestation (Group 1) and 40 women from 57 to 63 days' gestation (Group 2) inserted misoprostol vaginally 6 to 8 h after taking mifepristone. Participants were instructed to return 24 +/- 1 h after using misoprostol for an evaluation that included transvaginal ultrasonography. Subjects who had not aborted received a second dose of misoprostol to administer 48 h after the mifepristone. All participants were to return 2 weeks later. Ultrasound examinations were performed in those who required a second dose of misoprostol to confirm the abortion was successful. At 24 h after receiving misoprostol, 37/40 (93%, 95% CI 80, 98%) and 36/40 (90%, 95% CI 76, 97%) women from Groups 1 and 2, respectively, had expelled the pregnancy. By follow-up 2 weeks after taking mifepristone, all 40 women in Group 1 (100%, 95% CI 91,100%) and 39/40 women in Group 2 (98%, 95% CI 87,100%) had complete abortions. One woman in the latter group who aborted within the first 24 h had an incomplete abortion treated by suction curettage. This pilot study suggests that mifepristone 200 mg, followed on the same day by misoprostol 800 microg vaginally, effects abortion in women 50 to 63 days' gestation at rates comparable to regimens using longer dosing intervals between medications. Though this regimen is promising, larger randomized trials comparing it to standard regimens are needed before widespread use.
在之前一项针对40名妊娠49天及以内女性的研究中,我们的研究中心表明,200毫克米非司酮与800微克米索前列醇于同一天经阴道给药的流产率,与两种药物间隔24或48小时给药的标准方案相似。我们开展此项研究以评估同一方案在妊娠50至63天女性中的效果。40名妊娠50至56天的女性(第1组)和40名妊娠57至63天的女性(第2组)在服用米非司酮6至8小时后经阴道插入米索前列醇。受试者在使用米索前列醇后24±1小时被要求返回进行评估,评估内容包括经阴道超声检查。未流产的受试者在服用米非司酮48小时后接受第二剂米索前列醇。所有受试者在两周后返回。对那些需要第二剂米索前列醇的受试者进行超声检查,以确认流产是否成功。在接受米索前列醇24小时后,第1组的37/40名(93%,95%可信区间80, 98%)女性和第2组的36/40名(90%,95%可信区间76, 97%)女性排出了妊娠物。在服用米非司酮两周后的随访中,第1组的所有40名女性(100%,95%可信区间91, 100%)和第2组的39/40名女性(98%,95%可信区间87, 100%)均完全流产。后一组中一名在最初24小时内流产的女性出现不全流产,通过吸刮术治疗。这项初步研究表明,200毫克米非司酮与800微克米索前列醇于同一天经阴道给药,在妊娠50至63天的女性中引起流产的比率,与药物给药间隔更长的方案相当。尽管该方案前景良好,但在广泛应用之前,需要进行更大规模的随机试验将其与标准方案进行比较。