1 Key Laboratory for Reproduction and Genetics of Guangdong Higher-Education Institutes and Key Laboratory for Major Obstetric Diseases of Guangdong Province, The Third Affiliated Hospital, Guangzhou Institute of Obstetrics and Gynecology, Guangzhou Medical University, Guangzhou, People's Republic of China.
2 St Louis School, Hong Kong SAR, People's Republic of China.
Reprod Sci. 2017 May;24(5):731-737. doi: 10.1177/1933719116669055. Epub 2016 Sep 27.
The aim of this study was to investigate the efficacy, safety, and acceptability of low-dose mifepristone combined with self-administered misoprostol for ultra-early medical abortion. A total of 744 women with ultra-early pregnancy (amenorrhea ≤35 days) who fulfilled the inclusion criteria were enrolled in the study. Equal numbers of participants were allocated randomly to the hospital administration and self-administration groups. All participants took 75 mg mifepristone at the initial visit and 400 µg oral misoprostol 24 hours later in the hospital or by self-administration. The primary end point was complete abortion. Secondary end points were rates of unscheduled reattendance, time required for and cost of hospital observation and follow-up, vaginal bleeding, adverse effects, menstrual disturbance in the posttreatment period, and satisfaction rating. No differences in the rates of complete abortion, unscheduled reattendance, vaginal bleeding, adverse effects, or return of posttreatment menstruation were observed. The time required for (and costs of) hospital observation and follow-up per participant was 557.82 minutes (and US$40.12) in the hospital administration group and 18.46 minutes (and US$1.96) in the self-administration group (both P < .001). Satisfaction rates were similar in both groups, but the rates of "very satisfied" responses (87.60% vs 25.41%) and follow-up compliance (loss to follow-up, 0.45% vs 7.70%) were higher in the self-administration group (both P < .001). Low-dose mifepristone combined with self-administered misoprostol for ultra-early pregnancy termination was as effective and safe as hospital administration, with greater acceptability and lower cost to the women.
本研究旨在探讨小剂量米非司酮联合米索前列醇用于极早期药物流产的疗效、安全性和可接受性。共有 744 名符合纳入标准的极早期妊娠（闭经≤35 天）妇女参与了本研究。将参与者等分为医院管理组和自我管理组。所有参与者在初诊时均服用 75mg 米非司酮，24 小时后在医院或自行服用 400μg 口服米索前列醇。主要终点是完全流产。次要终点是未计划再次就诊率、医院观察和随访所需时间和费用、阴道出血、不良反应、治疗后月经紊乱以及满意度评分。完全流产率、未计划再次就诊率、阴道出血、不良反应或治疗后月经恢复无差异。医院管理组每名参与者的医院观察和随访所需时间（和费用）为 557.82 分钟（和 40.12 美元），自我管理组为 18.46 分钟（和 1.96 美元）（均 P <.001）。两组的满意度评分相似，但自我管理组的“非常满意”（87.60% 对 25.41%）和随访依从性（失访率，0.45% 对 7.70%）更高（均 P <.001）。小剂量米非司酮联合米索前列醇用于极早期妊娠终止与医院管理一样有效且安全，但更受患者欢迎且成本更低。
