Osuga Yutaka, Shirasu Kazuhiro, Tsushima Ruriko, Ishitani Ken
Department of Obstetrics and Gynecology, Graduate School of Medicine The University of Tokyo Tokyo Japan.
Division of Review Board Management Kanagawa National Health Insurance Organization Kanagawa Japan.
Reprod Med Biol. 2023 Mar 31;22(1):e12512. doi: 10.1002/rmb2.12512. eCollection 2023 Jan-Dec.
To evaluate the short-term efficacy and safety of a combined mifepristone-misoprostol regimen in individuals seeking medical abortion at up to 63 days of gestational age.
This open-label, multicenter, prospective study evaluated the short-term efficacy and safety of medical abortion, with the primary outcome being the abortion success rate 24 h after misoprostol administration. The participants received 200 mg of mifepristone orally and 800 μg of misoprostol buccally in the hospital/clinic 36-48 h later. Bleeding and lower abdominal pain, which are the main symptoms associated with medical abortion, were recorded.
The abortion success rate was 93.3% (95% confidence interval [CI]: 87.3-97.1%) within 24 h of misoprostol administration, 63.3% (95% CI: 54.05-71.94%) within 4 h, and 90.0% (95% CI: 83.18-94.73%) within 8 h. The median time from misoprostol administration to a successful abortion was 3.93 h. Bleeding was most commonly observed 0-4 h prior to the confirmation of gestational sac (GS) expulsion. The most intense lower abdominal pain occurred 0-1 h before the confirmation of GS expulsion.
The combined regimen of mifepristone and buccal misoprostol for medical abortion showed short-term efficacy and a favorable safety profile.
评估米非司酮-米索前列醇联合方案用于妊娠龄达63天的寻求药物流产者的短期疗效和安全性。
这项开放标签、多中心、前瞻性研究评估了药物流产的短期疗效和安全性，主要结局为米索前列醇给药后24小时的流产成功率。参与者口服200毫克米非司酮，36至48小时后在医院/诊所口腔含服800微克米索前列醇。记录与药物流产相关的主要症状——出血和下腹痛。
米索前列醇给药后24小时内流产成功率为93.3%（95%置信区间[CI]：87.3-97.1%），4小时内为63.3%（95%CI：54.05-71.94%），8小时内为90.0%（95%CI：83.18-94.73%）。米索前列醇给药至流产成功的中位时间为3.93小时。出血最常见于妊娠囊（GS）排出确认前0-4小时。下腹部最剧烈疼痛发生在GS排出确认前0-1小时。
米非司酮与口腔含服米索前列醇联合用于药物流产的方案显示出短期疗效和良好的安全性。
