Mifepristone in Combination with Misoprostol vs. Low Dose Mifepristone Alone in Emergency Contraception: a Multi-center Double-blind Randomized Clinical Trial

查看全文 作　　者：Xue zhe WU, Jing yu SHAO, Cui qin CHEN, Yi YANG Yun yu FA, Jian hua LIU, Xiao ai LIU, Yan ru LIU Shanghai Cooperative Research Group for Emergency Contraception 出　　处：《Journal of Reproduction and Contraception》索引2002年第13卷第3期,共7页 摘　　要：To compare the effectiveness and side effects of various low dose of Mifepristone in combination with Misoprostol and low doses Mifepristone alone in emergency contraception Materials & Methods This is a multi center double blind randomized controlled clinical trial. A total of 899 healthy women were allocated into this study and were randomly divided into 3 groups. They were orally administrated with different emergency contraceptives with 120 h after unprotected intercourse. Group I (n=300) was given 25 mg Mifepristone plus 0.2 mg Misoprostol after 24 h. Group II (n=299) was given 10 mg Mifepristone plus 0.2 mg Misoprostol after 24 h. Group III (n=300) was administrated with 10 mg Mifepristone alone. The effective rates in different groups were calculated with Dixon method. Results Altogether 11 pregnancies occurred, among which 2 cases were in Group I, 2 cases in Group II, and 7 cases were in Group III. After correction with method failure, there was only one case in Group I, 0 case in Group II, and 5 cases in Group III. The contraceptive effectiveness in these groups was 95.5%, 100% and 76.9% respectively. The pregnancy rate was significantly lower in Group I and Group II than that of Group III (P<0.01). The side effects were slight and tolerable, and there was no significant difference between different groups (P>0.05). Conclusion Use of low dose Mifepristone (25 mg or 10 mg) in combination with 0.2 mg Misoprostol was an effective, low side effects and safe treatment regimen for emergency contraception. 关 键 词：米非司酮 化合物 米索前列醇vs 低剂量 紧急避孕法 多中心双盲随机临床试验 怀孕