Gao J, Qiao G M, Wu Y M, Wu M E, Zheng S R, Han Z B, Fan H M, Yao G Z, Meng U, Dubois C
National Institute of Research for Family Planning, Beijing, People's Republic of China.
Contraception. 1988 Dec;38(6):675-83. doi: 10.1016/0010-7824(88)90049-2.
In a multicenter study taking place in four centers in Beijing (People's Republic of China), pregnancies up to 49 days of amenorrhea (DA) were interrupted with RU 486 (RU 38486, mifepristone, 600 mg orally once), followed 36-60 hours later by administration of dl-15-methyl-PGF 2 alpha-methyl ester (PG05, 1 mg vaginal suppository). One-hundred-and-sixty women were included in the study, three of whom being excluded from efficacy assessment because of non-compliance to the protocol. Complete pregnancy interruption without additional surgical procedure (success) was obtained in 136 women (86.6%, 95% confidence interval: 81.3-91.9%). The success rate was significantly (P = 0.013) higher for pregnancies below (91.3%), than for pregnancies above 42 days of amenorrhea (DA) (76.6%). The time elapsed between RU 486 intake and complete expulsion was 2.8 +/- 1.5 (sd) days (range: 1-12 days). Expulsion took place at the latest 4 days after RU 486 in 125 women (94.7%), and in 107 of these women, it occurred 3.1 +/- 1.7 (sd) hours after PG05 administration. Uterine bleeding occurred in all women after RU 486 intake whatever the outcome of treatment and lasted 11.5 +/- 4.8 (sd) days (range: 3-36 days). It was judged more or much more abundant than usual periods in 6.15% of the women. It led to a slight but significant decrease in hemoglobin as measured eight and 14 days after RU 486 intake. In five women, hemoglobin decreased by 4 g/dl or more, but no patient required a blood transfusion.(ABSTRACT TRUNCATED AT 250 WORDS)
在北京四个中心开展的一项多中心研究(中华人民共和国)中,停经49天(DA)以内的妊娠采用RU 486(RU 38486,米非司酮,口服600毫克一次)终止,36 - 60小时后给予dl-15-甲基-PGF 2α-甲酯(PG05,1毫克阴道栓剂)。160名女性纳入研究,其中3名因未遵守方案被排除在疗效评估之外。136名女性(86.6%,95%置信区间:81.3 - 91.9%)在未进行额外手术的情况下实现了完全终止妊娠(成功)。停经(DA)低于42天的妊娠成功率(91.3%)显著高于停经42天以上妊娠(76.6%)(P = 0.013)。从服用RU 486到完全排出的时间为2.8±1.5(标准差)天(范围:1 - 12天)。125名女性(94.7%)在服用RU 486后最晚4天排出,其中107名女性在给予PG05后3.1±1.7(标准差)小时排出。无论治疗结果如何,所有女性在服用RU 486后均出现子宫出血,持续11.5±4.8(标准差)天(范围:3 - 36天)。6.15%的女性出血被判定比平时月经量多或多得多。服用RU 486后8天和14天测量发现血红蛋白略有但显著下降。5名女性血红蛋白下降4 g/dl或更多,但无患者需要输血。(摘要截取自250字)