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

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

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200mg米非司酮1d或2d后再给予米索前列醇,按随机试验方法流程将其分为1d组(n=120)和2d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200mg后,分别于阴道后穹窿放置米索前列醇400μg。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8.5h和7.2h,诱导人工终止妊娠术的平均时间相差1h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),2d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10.1h和7.6h(P=0.013);孕龄>16孕周患者人工终止妊娠术时间分别为10.8h和7.2h(P=0.024)。结论米非司酮间隔1d和2d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2d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） hi or two days [（41-45） hi, 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.