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中华妇幼临床医学杂志(电子版) ›› 2013, Vol. 09 ›› Issue (04) : 507 -511. doi: 10.3877/cma.j.issn.1673-5250.2013.04.020

所属专题: 文献

论著

应用米非司酮不同间隔时间配合米索前列醇终止中期妊娠效果比较
郭继梅1, 吕玲1,*,*(), 宫玉环1   
  1. 1. 266002 山东青岛,青岛市第九人民医院妇产科
  • 收稿日期:2013-01-18 修回日期:2013-06-20 出版日期:2013-08-01
  • 通信作者: 吕玲

One- and Two-Day Dosing Intervals Between Mifepristone and Misoprostol in Second Trimester Medical Termination of Pregnancy

Ji-mei GUO1, Ling LYU1(), Yu-huan GONG1   

  1. 1. Department of Gynecology and Obstetrics, Qingdao Ninth People's Hospital, Qingdao 266002, Shandong Province, China
  • Received:2013-01-18 Revised:2013-06-20 Published:2013-08-01
  • Corresponding author: Ling LYU
  • About author:
    (Corresponding author: LYU Ling, Email: )
引用本文:

郭继梅, 吕玲, 宫玉环. 应用米非司酮不同间隔时间配合米索前列醇终止中期妊娠效果比较[J/OL]. 中华妇幼临床医学杂志(电子版), 2013, 09(04): 507-511.

Ji-mei GUO, Ling LYU, Yu-huan GONG. One- and Two-Day Dosing Intervals Between Mifepristone and Misoprostol in Second Trimester Medical Termination of Pregnancy[J/OL]. Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition), 2013, 09(04): 507-511.

目的

探讨应用米非司酮不同间隔时间配合米索前列醇于孕中期人工终止妊娠的效果。

方法

随机选择2009年5月至2011年7月于本院妇产科行孕中期人工终止妊娠术患者227例为研究对象,根据口服200 mg米非司酮1 d或2 d后再给予米索前列醇,按随机试验方法流程将其分为1 d组(n=120)和2 d组(n=107)(本研究遵循的程序符合本院人体试验委员会制定的伦理学标准,分组征得受试对象的知情同意,并与之签署临床研究知情同意书)。2组患者应用米非司酮200 mg后,分别于阴道后穹窿放置米索前列醇400 μg。比较两组患者的人工终止妊娠术时间、人工终止妊娠术后清宫率、不良反应及并发症;并考察患妊娠史与妊娠时间对终止妊娠的影响。

结果

2组人工终止妊娠术时间分别为8.5 h和7.2 h,诱导人工终止妊娠术的平均时间相差1 h以上,差异有统计学意义(P=0.038);2组手术清宫率分别为25%(30/115)和37%(40/112),2 d组手术清宫率高(P=0.044)。2组患者中,无阴道分娩史患者人工终止妊娠术时间分别为10.1 h和7.6 h(P=0.013);孕龄>16孕周患者人工终止妊娠术时间分别为10.8 h和7.2 h(P=0.024)。

结论

米非司酮间隔1 d和2 d的用药方案都适合孕中期人工终止妊娠术,但对无分娩史和孕龄>16孕周的患者可能用药间隔2 d效果更好。具体选用何种用药方案要根据临床需要决定。

Objective

To compare one- and two-day intervals in second trimester medical termination of pregnancy(TOP).

Methods

This open randomized trial included 227 women undergoing TOP between gestational weeks 13-24. Mifepristone(200 mg) was followed by misoprostol(400 μg) after one day [(17-28) h] or two days [(41-45) h], as 1 d group (n=120) and 2 d group (n=107). The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Qingdao Ninth People's Hospital. Two groups were compared abortion time, after curettage abortion rate, adverse reactions and complications; and examines the history of suffering from pregnancy and pregnancy influence of time on TOP.

Results

In intention-to-treat analysis, the median induction-to-abortion interval was 1 h longer in the 1 d group(8.5 h vs. 7.2 h, P=0.038), but in per-protocol analysis, the rate of surgical evacuation was higher in the 2 d group [25%(30/115) vs. 37%(40/112); 95% confidence interval 0.3-24.1, P=0.044]. A subgroup analysis showed that the median induction-to-abortion interval was 3 h longer in the 1 d group, amongst women without previous vaginal deliveries(10.1 h vs. 7.6 h, P=0.013) and when gestation exceeded 16 weeks(10.8 h vs. 7.2 h, P=0.024).

Conclusions

Both one- and two-day dosing intervals seem to be suitable for second trimester medical TOP, but women with no previous deliveries and those whose gestation exceeds 16 weeks may benefit from the longer interval. However, evaluated on the basis of surgical evacuation, the one-day interval could be supported as an option for second trimester medical TOP. Effective use of both one- and two-day dosing intervals is important when optimizing clinical service.

图1 随机试验研究流程图
Figure 1 The study flow chart of the randomized trial
表1 2009年5月至2011年7月227例患者中期引产情况
Table 1 The primary outcomes of 227 women underwent artificial abortion during second trimester between May 2009 and July 2011
图2 1 d组和2 d组人工终止妊娠术率
Figure 2 The cumulative rate of pregnanccy termination in 1 d group and 2 d group
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