二种单剂量RU486合并ONO802终止57～63天妊娠的随机双盲法比较研究

本研究共接纳停经５７～６３ｄ的健康早孕妇女１００例，按随机双盲法分为二组，分别口服ＲＵ４８６２００ｍｇ和６００ｍｇ，４８ｈ后加用阴道栓剂ＯＮＯ８０２１ｍｇ。完全流产率分别为９６．０％和９４．０％；两组各有上例继续妊娠，２００ｍｇ组有１例不全流产，而６００ｍｇ组有２例，两组间无明显差异。２００ｍｇ组一例不全流产者输血２００ｍｌ。用药后副反应都较轻微，无需特殊处理。两组阴道流血量、流血持续时间及转经天数相似。实验结果表明：６００ｍｇ及２００ｍｇ单剂量ＲＵ４８６合并１ｍｇＯＮＯ８０２对终止停经５７～６３ｄ的早孕是有效的；２００ｍｇ单剂量ＲＵ４８６可达到６００ｍｇ同样的效果。

A Double Blind Randomized Comparison of Two Single Doses of Mifepristone(RU486) Plus Gemeprost for Termination of Pregnancy with Amenorrhea between 57 and 63 Days

cases of healty pregnant women with amenorrhea between 57～63 days had been recruited for the clinical trial.The patients were allocated in 2 groups by way of double-blind randomization.Women received a single dose of either 200mg or 600mg mifepristone(RU486)plus 1 mg vaginal suppository of ONO 802 48 hours later.All subjects were asked to attend the hospital on each treatment day,and day 8,15,43 for follow-up visit.The complete abortion rates were 96.0% and 94.0% respectively.The 200 mg group had 1 case whereas 600mg group had 2 cases of incomplete abortion.One case in either group resulted in continuation of pregnancy.One case of incomplete abortion in 200 mg group was needed blood transfusion.There were no significant difference in efficacy between 2 groups.The side effects were minor, no special treatment was needed.The amount and duration of vaginal bleeding as well as time to first menses were similar in both groups.In conclusion,either a single dose 200 mg or 600 ma RU486 plus 1 mg vaginal suppository ONO 802 were effectively in termination of early pregnancy with amenorrhea between 57￣63 days.A lower dose(200mg)of RU486 was sufficient than currently recomended dose(600mg)for pregnancy termination.