米索前列醇和PG05配伍米非司酮终止早孕的临床多中心随机比较试验

A Multi-centre Randomized Comparative Trial on Misoprostol and PG05 with Pretreated Mifepristone for Termination of Early Pregnancy

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 multi-centre randomized clinical trial was conducted to compare safety,efficacy and acceptability of the following regimens for termination of early pregnancy: mifepristone 25mg Q12h for 5 doses plus suppository PG05(dl-methyl PGF2a-methyl ester,1mg) (GroupⅠ) or plus AGE1 analogue misoprostol 600μg (GroupⅡ),and mifepristone 200mg in one single dose plus misoprostol 600μg (Group Ⅲ ). The total complete abortion rate was 94.22% (913/969), it was significantly lower in Group Ⅲ (91.50%) than in Group Ⅰ (95.22%) and Group Ⅱ (96. 12% ) (p= 0. 025). The failure rate was 1. 65% (16/969) in three groups, among which it was statisticaly higher in Group'Ⅲ (3.52%) as compared with those in Group Ⅰ (1.37%) and Group Ⅱ (0) (P-0.001). The percentages of incomplete abortion and the subjects lost to follow-up were 2.89% (28/969) and 1.24% (12/969) respectively, both, however, were similar in the three groups (P>0.05) .Whereas the time from the PG intake to the expulsion of gestational sac was significantly shorter in Group Ⅱ (2. 81±12.75h) than in Group Ⅰ (3. 06±1.65h) and Group'Ⅲ (3. 21± 1. 61h) (X± SD) (P<0. 05) . There were no differences in duration of vaginal bleeding and time to first mense in three groups.Overall,more than 90% of subjects were satisfied with the methods for induced:abortion.Thus,the results indicated that, first, in terms of safety, effieaey and acceptability,misoprostol combined with mifepristone for termination of early pregnancy was satisfactory as eompared with PG05; second, mifepristone administered in multiPle low doses presented better abortifacient effect than that in one single dose when combined with the same dose of misoprostol.