不同剂量米非司酮及合并双炔失碳酯用于紧急避孕的多中心随机临床研究  

A Randomized Multicentre Clinical Trial on Different Doses of Mifepristone Alone and in Combination with Anordrin as Emergency Contraception SANG Guowei*, SHAO Qingxiang*, ZHANG Lijia, et al.*

作　　者：桑国卫[1,2,3,4,5,6,7] 邵庆翔[1,2,3,4,5,6,7] 张莉嘉 张美云[1,2,3,4,5,6,7] 陈素芳[1,2,3,4,5,6,7] 宋思 杜明昆[1,2,3,4,5,6,7] 吴学浙 丁菊红[1,2,3,4,5,6,7] 翁梨驹[1,2,3,4,5,6,7] 

机构地区：[1]浙江省医学科学院 [2]首都医科大学附属北京朝阳医院 [3]四川省计划生育科学技术研究所 [4]上海市计划生育科学技术研究所 [5]上海医科大学妇产科医院 [6]上海市第一妇婴保健院 [7]江苏省计划生育科学技术研究所

出　　处：《中华妇产科杂志》1999年第6期331-334,共4页Chinese Journal of Obstetrics and Gynecology

摘　　要：目的了解在无保护性交后９６小时内应用不同剂量米非司酮及与双炔失碳配伍用于紧急避孕的效果及其副反应。方法将无保护性交后９６小时内的２４００例健康育龄妇女随机分为４组（每组６００例），分别予单次口服２５ｍｇ米非司酮、２５ｍｇ米非司酮加７．５ｍｇ双炔失碳酯、１０ｍｇ米非司酮加５ｍｇ双炔失碳酯及１０ｍｇ米非司酮。按Ｄｉｘｏｎ法推算避孕有效率。结果除２例接纳错误和１１例失访外，２３８７例妇女的总预期妊娠数为１７１．９例，实际妊娠３２例。４组的避孕有效率分别为８０．９％、８５．３％、９０．６％和６７．３％。１０ｍｇ米非司酮配伍５ｍｇ双炔失碳酯的避孕失败率０．７％，显著低于单次口服１０ｍｇ米非司酮者（２．２％）（Ｐ＜０．０５）。４组的诱导性出血发生率分别为９．２％、４．９％、３．４％和６．７％，配伍双炔失碳酯后诱导性出血发生率明显低于单次口服米非司酮者（Ｐ＜０．０１）。结论２５ｍｇ米非司酮或者１０ｍｇ米非司酮合并５ｍｇ双炔失碳酯为安全有效的紧急避孕方案。ObjectivesWT5BZTo investigate the effectiveness and sideeffects of different doses of mifepristone alone or in combination with anordrin given orally within 96 hours after unprotected intercourse as an emergency contraceptive. Methods 2 400 cases of healthy women were recruited and allocated randomly in 4 groups: single dose of 25 mg mifepristone, 25 mg mifepristone plus 7.5 mg anordrin, 10 mg mifepristone plus 5 mg anordrin and 10 mg mifepristone alone. The efficacy rates of contraception were estimated according to Dixon method. Results The total expected number of pregnancy was 171.9 for 2 387 subjects enrolled in the study. The number of observed pregnancies related to method failure was 32 cases. The contraceptive effectiveness rates for the above 4 groups were 80.9%, 85.3%, 90.6% and 67.3%, respectively. For the group received 10 mg mifepristone plus 5 mg anordrin, pregnancy rate was 0.7% which was significantly lower than that in 10 mg mifepristone alone group (2.2%, P<0.05). The incidences of withdrawal bleeding were 9.2%, 4.9%, 3.4% and 6.7% for the 4 group respectively. Two groups received mifepristone in combination with anordrin showed significant lower incidence of withdrawal bleeding than those in mifepristone alone groups. Conclusion Single oral administration of 25 mg mifepristone alone, and the combination of 10 mg mifepristone plus 5 mg anordrin were safe and effective treatment regimen for emergency contraception with no serious adverse reaction and disturbance on menstrual pattern.

关 键 词：米非司酮 避孕 双炔失碳酯 紧急避孕 

分 类 号：R169.41[医药卫生—公共卫生与预防医学] R979.21