Gynuity Health Projects, 15 East 26th Street, Suite 801, New York, NY 10010, USA.
Contraception. 2013 Jan;87(1):26-37. doi: 10.1016/j.contraception.2012.06.011. Epub 2012 Aug 13.
The dose of mifepristone approved by most government agencies for medical abortion is 600 mg. Our aim was to summarize extant data on the effectiveness and safety of regimens using the widely recommended lower mifepristone dose, 200 mg, followed by misoprostol in early pregnancy and to explore potential correlates of abortion failure.
To identify eligible reports, we searched Medline, reviewed reference lists of published reports, and contacted experts to identify all prospective trials of any design of medical abortion using 200 mg mifepristone followed by misoprostol in women with viable pregnancies up to 63 days' gestation. Two authors independently extracted data from each study. We used logistic regression models to explore associations between 15 characteristics of the trial groups and, separately, the rates of medical abortion failure and of ongoing pregnancy.
We identified 87 trials that collectively included 120 groups of women treated with a regimen of interest. Of the 47,283 treated subjects in these groups, abortion outcome data were reported for 45,528 (96%). Treatment failure occurred in 2,192 (4.8%) of these evaluable subjects. Ongoing pregnancy was reported in 1.1% (499/45,150) of the evaluable subjects in the 117 trial groups reporting this outcome. The risk of medical abortion failure was higher among trial groups in which at least 25% of subjects had gestational age >8 weeks, the specified interval between mifepristone and misoprostol was less than 24 h, the total misoprostol dose was 400 mcg (rather than higher), or the misoprostol was administered by the oral route (rather than by vaginal, buccal, or sublingual routes). Across all trials, 119 evaluable subjects (0.3%) were hospitalized, and 45 (0.1%) received blood transfusions.
Early medical abortion with mifepristone 200 mg followed by misoprostol is highly effective and safe.
大多数政府机构批准的用于药物流产的米非司酮剂量为 600 毫克。我们的目的是总结现有数据，评估广泛推荐的较低剂量（200 毫克）米非司酮序贯米索前列醇在早孕中的有效性和安全性，并探讨流产失败的潜在相关因素。
为了确定合格的报告，我们检索了 Medline，查阅了已发表报告的参考文献，并联系了专家，以确定所有设计的前瞻性试验，这些试验均使用米非司酮 200 毫克序贯米索前列醇治疗孕龄不超过 63 天的有活力妊娠的女性。两位作者独立地从每项研究中提取数据。我们使用逻辑回归模型来探讨试验组 15 个特征与药物流产失败率和持续妊娠率之间的关系。
我们确定了 87 项试验，这些试验总共包括 120 组接受研究方案治疗的女性。在这些组中，47283 名接受治疗的受试者中，有 45528 名（96%）报告了流产结局数据。在这些可评估的受试者中，2192 名（4.8%）发生了治疗失败。在 117 个报告该结局的试验组中，有 1.1%（499/45150）可评估的受试者报告了持续妊娠。在至少 25%的受试者妊娠龄>8 周、米非司酮和米索前列醇之间的指定间隔小于 24 小时、总米索前列醇剂量为 400 mcg（而不是更高）或米索前列醇通过口服途径（而不是阴道、颊或舌下途径）给药的试验组中，药物流产失败的风险更高。在所有试验中，有 119 名可评估的受试者（0.3%）住院，45 名（0.1%）接受输血。
米非司酮 200 毫克序贯米索前列醇早期药物流产非常有效且安全。
