Song Li-Ping, Tang Shi-Yan, Li Cui-Lan, Zhou Lee-Jaden-Gil-Yu-Kang, Mo Xue-Tang
Key Laboratory for Major Obstetric Diseases of Guangdong Province, Key Laboratory for Reproduction and Genetics of Guangdong Higher-Education Institutes, Guangzhou Institute of Obstetrics and Gynecology, Third Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.
Grade 10, Walt Whitman High School, Bethesda, Maryland, USA.
J Obstet Gynaecol Res. 2018 Sep;44(9):1705-1711. doi: 10.1111/jog.13716. Epub 2018 Jul 5.
The aim of the present study was to investigate the safety and efficacy of low-dose mifepristone combined with self-administered misoprostol for termination of early pregnancy.
A total of 533 women seeking medical abortion in early pregnancy (≤49 days since the last menstrual period) were divided randomly into hospital- (H-Mis, 250) and self- (S-Mis, 283) administered misoprostol groups. Women in two groups took 100 mg of oral mifepristone in hospital followed by 200 μg of sublingual misoprostol 24 h later in hospital or home. The primary outcome parameter was complete abortion without surgical intervention. Secondary outcomes were uterine bleeding, return of regular menses, side effects and patient acceptability.
High rates of complete abortion were observed for both the H-Mis group (243/250; 94.8%) and the S-Mis group (266/283; 94.0%). No significant differences in outcomes (complete abortion/failure rates) or side effects were observed between the two groups. General satisfaction rates were similar for the two groups (H-Mis, 231/250, 92.4%; S-Mis, 263/283, 92.9%; P > 0.05). Higher convenience of administration (H-Mis, 211/250, 84.4%; S-Mis, 270/283, 95.4%; P < 0.05) and privacy protection (H-Mis, 214/250, 85.6%; S-Mis, 267/283, 94.3%; P < 0.05) satisfaction rates were obtained for the S-Mis group than for the H-Mis group.
Self-administered sublingual misoprostol is as safe and effective as hospital-administered misoprostol following low-dose mifepristone to terminate early pregnancy (≤49 days of amenorrhoea) with fewer side effects.
本研究旨在探讨低剂量米非司酮联合自行服用米索前列醇终止早期妊娠的安全性和有效性。
共有533名早期妊娠(自末次月经起≤49天)寻求药物流产的女性被随机分为医院给药米索前列醇组(H-Mis,250例)和自行给药米索前列醇组(S-Mis,283例)。两组女性均在医院口服100mg米非司酮,24小时后在医院或家中舌下含服200μg米索前列醇。主要结局参数为无需手术干预的完全流产。次要结局包括子宫出血、月经恢复、副作用及患者可接受性。
H-Mis组(243/250;94.8%)和S-Mis组(266/283;94.0%)的完全流产率均较高。两组在结局(完全流产/失败率)或副作用方面未观察到显著差异。两组的总体满意率相似(H-Mis组,231/250,92.4%;S-Mis组,263/283,92.9%;P>0.05)。S-Mis组在给药便利性(H-Mis组,211/250,84.4%;S-Mis组,270/283,95.4%;P<0.05)和隐私保护(H-Mis组,214/250,85.6%;S-Mis组,267/283,94.3%;P<0.05)方面的满意率高于H-Mis组。
低剂量米非司酮后自行舌下含服米索前列醇在终止早期妊娠(闭经≤49天)方面与医院给药米索前列醇一样安全有效,且副作用更少。