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本研究为一项由十个单位参加的多中心临床试验，随机比较了三种用药方案：１．米非司酮２５ｍｇＱ１２ｈ×５＋ＰＧ０５１ｍｇ阴道塞药（组Ⅰ），２．米非司酮，同前十米索６００μｇ（组Ⅱ），３．米非司酮２００ｍｇ＋米索６００μｇ（组Ⅲ）终止早孕的安全性、有效性和可接受性。结果显示完全流产率为９４．２２％（９１３／９６９），其中组Ⅲ为９１．５０％，明显低于组Ⅰ（９５．２２％）和组Ⅰ（９６．１２％）（Ｐ＝０．０２５）；失败率为１．６５％（１６／９６９），其中组Ⅲ为３．５２％，显著高于组Ⅰ（１．３７％）、组Ⅱ（０％）（Ｐ＝０．００１）；不完全流产率为２．８９％（２８／９６９），失访（结局不明）率为１．２４％（１２／９６９），三组间均无明显差异（Ｐ＞０．０５）；自应用ＰＧ至孕囊排出时间，三组分别为３．０６±１．６５，２．８１±２．７５，３．２１±１．６１ｈ（Ｘ±ＳＤ），组Ⅱ稍短于其他两组，其差异有统计学意义（Ｐ＜０．０５）；阴道出血持续时间和转经时间无明显组间差异（Ｐ＞０．０５）。９０％以上的对象均对药物流产方法表示满意。结果提示米索配伍米非司酮的安全性、有效性和可接受性令人满意；米非司酮低剂量多次给药与米索有较好的协同作用。
This study, a multicentre clinical trial involving 10 units, randomly compared three medication regimens: 1. Mifepristone 25mgQ12h × 5 + PG051mg vaginal plug drug (group Ⅰ), 2. Mifepristone, with the first ten meters cable 600μg (group Ⅱ), 3. Mifepristone 200mg + Misoprostol 600μg (Group Ⅲ) Termination of early pregnancy safety, efficacy and acceptability. The results showed that the rate of complete abortion was 94.22% (913/969), in which group Ⅲ was 91.50%, which was significantly lower than that of group Ⅰ (95.22%) and group Ⅰ (96.12%) (P = 0. 025). The failure rate was 1.65% (16/969), in which group Ⅲ was 3.52%, significantly higher than group Ⅰ (1.37%) and group Ⅱ (0%) (P = 0.001) ; The rate of incomplete abortion was 2.89% (28/969), and the rate of lost follow-up (unknown outcome) was 1.24% (12/969). There was no significant difference between the three groups (P> 0.05) The time from application of PG to gestational sac was 3.06 ± 1.65,2.81 ± 2.75,3.21 ± 1.61h (X ± SD) in the three groups, slightly shorter in group Ⅱ than in the other two groups, The difference was statistically significant (P <0.05). There was no significant difference between the duration of vaginal bleeding and the transit time (P> 0.05). Over 90% of the subjects are satisfied with the medical abortion method. The results suggest that the compatibility of mifepristone with mifepristone is satisfactory. The efficacy and acceptability of mifepristone are satisfactory. Multiple doses of mifepristone combined with misoprostol have good synergistic effects.