Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
BJOG. 2010 Sep;117(10):1186-96. doi: 10.1111/j.1471-0528.2010.02636.x. Epub 2010 Jun 18.
To compare 400 and 800 microg sublingual or vaginal misoprostol 24 hours after 200 mg mifepristone for noninferiority regarding efficacy in achieving complete abortion for pregnancy termination up to 63 days of gestation.
Placebo-controlled, randomised, noninferiority factorial trial, stratified by centre and length of gestation. Misoprostol 400 or 800 microg, administered either sublingually or vaginally, with follow up after 2 and 6 weeks.
Fifteen obstetrics/gynaecology departments in ten countries.
Pregnant women (n = 3005) up to 63 days of gestation requesting medical abortion.
Two-sided 95% CI for differences in failure of complete abortion and continuing pregnancy, with a 3% noninferiority margin, were calculated. Proportions of women with adverse effects were recorded.
Complete abortion without surgical intervention (main); continuing live pregnancies, induction-to-abortion interval, adverse effects, women's perceptions (secondary).
Efficacy outcomes analysed for 2962 women (98.6%): 90.5% had complete abortion after 400 microg misoprostol, 94.2% after 800 microg. Noninferiority of 400 microg misoprostol was not demonstrated for failure of complete abortion (difference: 3.7%; 95% CI 1.8-5.6%). The 400-microg dose showed higher risk of incomplete abortion (P < 0.01) and continuing pregnancy (P < 0.01) than 800 microg. Vaginal and sublingual routes had similar risks of failure to achieve complete abortion (P = 0.47, difference in sublingual minus vaginal -0.7%, 95% CI -2.6-1.2%). A similar pattern was observed for continuing pregnancies (P = 0.21). Fewer women reported adverse effects with vaginal than sublingual administration and with the 400-microg dose than the 800-microg dose. Of the women, 94% were satisfied or highly satisfied with the regimens, 53% preferred the sublingual route and 47% preferred the vaginal route.
A 400-microg dose of misoprostol should not replace the 800-microg dose when administered 24 hours after 200 mg mifepristone for inducing abortion in pregnancies up to 63 days. Sublingual and vaginal misoprostol have similar efficacy, but vaginal administration is associated with a lower frequency of adverse effects.
比较米非司酮 200mg 后 24 小时，舌下或阴道给予 400μg 或 800μg 米索前列醇在妊娠 63 天内终止妊娠的完全流产方面的非劣效性。
安慰剂对照、随机、非劣效性析因试验，按中心和妊娠时间分层。米索前列醇 400μg 或 800μg，分别舌下或阴道给药，2 周和 6 周后随访。
10 个国家的 15 个妇产科部门。
要求药物流产的妊娠（n=3005）至 63 天。
计算双侧 95%置信区间（CI）以比较完全流产失败和继续妊娠的差异，非劣效性边界为 3%。记录不良反应的妇女比例。
无手术干预的完全流产（主要）；继续活产、诱导至流产间隔、不良反应、妇女认知（次要）。
对 2962 名妇女（98.6%）进行了疗效分析：400μg 米索前列醇后 90.5%完全流产，800μg 后 94.2%。400μg 米索前列醇在完全流产失败方面未显示非劣效性（差异：3.7%；95%CI 1.8-5.6%）。400μg 剂量的不完全流产（P<0.01）和继续妊娠（P<0.01）的风险高于 800μg。阴道和舌下途径的完全流产失败风险相似（P=0.47，舌下减去阴道差异-0.7%，95%CI-2.6-1.2%）。继续妊娠也观察到类似模式（P=0.21）。与舌下给药和 800μg 剂量相比，阴道给药的不良反应报告较少。94%的妇女对方案满意或非常满意，53%的妇女更喜欢舌下途径，47%的妇女更喜欢阴道途径。
当在妊娠 63 天内使用米非司酮 200mg 后 24 小时诱导流产时，400μg 米索前列醇剂量不应替代 800μg 剂量。舌下和阴道给予米索前列醇具有相似的疗效，但阴道给药不良反应发生率较低。
