Simultaneous administration of mifepristone and misoprostol for early termination of pregnancy: a randomized controlled trial
Simultaneous administration of mifepristone and misoprostol for early termination of pregnancy: a randomized controlled trial
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DOI：
10.1007/s00404-011-1881-2
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发表时间：
2011-03
影响因子：
2.6
通讯作者：
A. Goel;S. Mittal;B. Taneja;N. Singal;Shivani Attri
中科院分区：
文献类型：
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作者：
A. Goel;S. Mittal;B. Taneja;N. Singal;Shivani Attri
目的比较米索前列醇不同给药间隔的疗效（同时维斯维斯24小时），米非司酮后，方法将80例妊娠≤7周的单次宫内妊娠要求流产的符合条件的妇女随机分为两组，一组口服米非司酮200 mg，另一组同时阴道注射米索前列醇400 μg（给药后无出血的妇女在第一次给药后24小时给予第二次剂量的米索前列醇。所有患者均于第14天随访。主要结果指标是完全流产率。次要结局指标为引产-流产间隔、不良反应（尤其是出血）和治疗可接受率。治疗被认为是一个失败，如果手术干预是必要的任何indication.ResultsComplete流产达到38名妇女[95%; 95%置信区间（CI）88%，100%]在第1组和39名妇女（97.50%; 95%CI 93%，100%）在第2组（p= 0.56）。第1组中有2例患者需要第二剂米索前列醇，第2组中只有1例患者需要第二剂米索前列醇。第1组的引产-流产间隔为6.50 ± 1.48小时，第2组为5.95 ± 1.81小时（p= 0.13）。两组不良反应发生频率的差异无统计学意义（p= 0.18）。结论米非司酮配伍米索前列醇400 μg阴道给药是妊娠49 d以内药物流产的有效替代方案。
AimTo compare the efficacy of different intervals of misoprostol administration (simultaneously vis-à-vis 24 h), after mifepristone, in women undergoing medical termination of pregnancy up to gestation of 49 days.MethodsEighty eligible women with single intrauterine pregnancy of ≤7 weeks of gestation requesting abortion were randomized to receive either 200 mg of mifepristone orally and 400 μg of misoprostol vaginally simultaneously (Group 1) or at 24-h interval (Group 2).Women who had no bleeding after the drugs were offered a second dose of misoprostol 24 h after the first dose. All patients were followed up on day 14. Primary outcome measure was the complete abortion rate. Secondary outcome measures were the induction–abortion interval, adverse effects, especially bleeding, and treatment acceptability rate. Treatment was considered a failure if surgical intervention was needed for any indication.ResultsComplete abortion was achieved in 38 women [95%; 95% confidence interval (CI) 88%, 100%] in Group 1 and 39 women (97.50%; 95% CI 93%,100%) in Group 2 (p= 0.56). A second dose of misoprostol was needed in two patients in Group 1 and in only one patient in Group 2. The induction–abortion interval was 6.50 ± 1.48 h in Group 1 and 5.95 ± 1.81 h in Group 2 (p= 0.13). The difference in frequency of adverse effects in the two groups was statistically insignificant (p= 0.18). The treatment acceptability rate was 97.50% in Group 1 and 95% in Group 2 (p= 0.56).ConclusionSimultaneous administration of mifepristone and 400 μg vaginal misoprostol is an effective alternative to standard regimens for medical abortion up to 49 days of gestation.