米非司酮联合米索前列醇用于终止妊娠8至16周的有效性和安全性

[Efficacy and safety of mifepristone combined with misoprostol for termination of pregnancy between 8 and 16 weeks of gestation].

作者信息

Qian Jinfeng, Jing Xiaoping, Wu Shuying, Zheng Shurong, Li Yi, Ren Mulan, Di Wen, Shen Huan, Dong Baihua, Chang Qing, Shi Huirong, Yao Chen, Song Wei, Huang Zirong

机构信息

Department of Family Planning, Obstetrics and Gynecology Hospital, Fudan University, Shanghai 200011, China.

Email:

出版信息

Zhonghua Fu Chan Ke Za Zhi. 2015 Jul;50(7):505-9.

PMID:26311640

Abstract

OBJECTIVE

To assess the efficacy and safety of mifepristone combined with oral or vaginal misoprostol for termination of pregnancy between 8 and 16 weeks of gestation.

METHODS

This was a randomized, multi-center, open clinical trial. A total of 625 women at 8-16 weeks of gestation were randomized to receive 200 mg oral mifepristone followed by either oral misoprostol 400 µg every 3 hours or vaginal misoprostol 400 µg every 6 hours for a maximum of 4 doses 36-48 hours later. There were 417 women in oral group with 198 at 8-9 weeks and 219 at 10-16 weeks, while 208 women in vaginal group with 99 at 8-9 weeks and 109 at 10-16 weeks. The outcome measures were the success abortion rate, induction to abortion interval, the amount of bleeding, reoccurrence of menstruation and adverse events.

RESULTS

Abortion rate was significantly higher in vaginal group [98.1% (202/206)] than that in oral group [94.0% (390/415), P = 0.023]; concerning termination of pregnancy at 8-9 weeks and 10-16 weeks respectively, there were no significant differences between oral and vaginal groups (P = 0.156, P = 0.073). The induction to abortion interval was no significant difference in oral and vaginal group in different gestational weeks (P = 0.238, P = 0.273). The average induction to abortion interval was (4.1 ± 6.6) hours and (6.0 ± 4.5) hours respectively in terminating 8-9 weeks and 10-16 weeks of gestation. Concerning the amount of bleeding within 2 hours of placenta expulsion, there was significant difference between oral group [(63 ± 46) ml] and vaginal group [(55 ± 45) ml] in terminating 8-9 weeks of gestation (P = 0.047), while there was no significant difference between groups in terminating 10-16 weeks of gestation [oral group (76 ± 52) ml versus vaginal group (76 ± 61) ml, P = 0.507]. The reoccurrence of menstruation was about 37 days in both oral and vaginal groups. Two cases of incomplete abortion were serious adverse events (SAE) relating to treatment. The common adverse events (AE) of nausea and vomiting were significantly higher in oral group [57.2% (239/417), 36.3% (151/417)] than those in vaginal group [45.4% (94/208), 26.1% (54/208); P = 0.005, 0.011].

CONCLUSION

Oral or vaginal misoprostol combined with mifepristone, is effective and safe for termination of pregnancy between 8 and 16 weeks of gestation.

摘要

目的

评估米非司酮联合口服或阴道用米索前列醇终止8至16周妊娠的有效性和安全性。

方法

这是一项随机、多中心、开放的临床试验。共有625例妊娠8至16周的妇女被随机分为两组，一组先口服200mg米非司酮，随后每3小时口服400μg米索前列醇，另一组先口服200mg米非司酮，随后每6小时阴道用400μg米索前列醇，最多用药4剂，36至48小时后观察。口服组有417例妇女，其中198例妊娠8至9周，219例妊娠10至16周；阴道组有208例妇女，其中99例妊娠8至9周，109例妊娠10至16周。观察指标包括流产成功率、引产至流产间隔时间、出血量、月经恢复情况及不良事件。

结果

阴道组流产率[98.1%（202/206）]显著高于口服组[94.0%（390/415），P = 0.023]；分别针对8至9周和10至16周的妊娠终止情况，口服组与阴道组之间无显著差异（P = 0.156，P = 0.073）。不同孕周时，口服组和阴道组的引产至流产间隔时间无显著差异（P = 0.238，P = 0.273）。在终止8至9周妊娠时，胎盘娩出后2小时内的出血量，口服组[（63±46）ml]与阴道组[（55±45）ml]有显著差异（P = 0.047），而在终止10至16周妊娠时，两组间无显著差异[口服组（76±52）ml，阴道组（76±61）ml，P = 0.507]。口服组和阴道组月经恢复时间均约为37天。有2例不全流产属于与治疗相关的严重不良事件。口服组恶心、呕吐等常见不良事件发生率[57.2%（239/417），36.3%（151/417）]显著高于阴道组[45.4%（94/208），26.1%（54/208）；P = 0.005，0.011]。