三种不同剂量RU486合并ONO802终止早孕的临床研究

A Clinical Randomized Comparative Study of Early Pregnancy Termination with 3 Treatment Regimens of RU 486(Mifepristone)Combined with the Prostaglandin Analogue Gemeprost

本研究比较了不同剂量RU486合并ONO802用于终止早孕(停经天数≤56d)的临床有效性及其副反应。从1989年5月至1991年1月,我们共接纳了99例对象(分三组,每组33例)。各组对象分别服用200mg、400mg 或600mg 的RU486,在第三天早晨阴道给药ONO802 1mg。三组治疗结果相似,其完全流产率分别为94%、100%和100%,无明显统计学差异。在200mg 组有2例(6%)为不全流产并由于流血较多施行了刮宫术,其中1例输血200ml。三纽均来继续妊娠。除轻微腹痛外,三组均无明显副反应。ONO802阴道给药后,各组胚囊排出时间为3.5h、3.2h 和3.2h,其间亦无统计学差异。但终止妊娠后阴道流血时间200mg组明显短于400mg 组和600mg 组,分别为11.5d、14.0d 和16.1d,有显著差异(P<0.01)。本文提示RU486合并ONO802用于终止早孕时,200mg 的RU486就可能足够了。

The object of the study was to compare the clinical efficacy and side effects of there combinationregimens of the antiprogestin RU 486 and gemeprost(ONO 802)Intravaginally for termination ofearly pregnancy(amenorrhea up to 56 days).From May 1989 to Jan.1991,we had recruited 99volunteers.Woman received a single oral dose of RU 486 200mg or 600mg plus 1 mg gemeprostintravaginally in the morning of the third day of antiprogestin treatment.There were 33 cases in eachreimen(group).Treatment outcome in three groups was similar.The complete abortion rates were94%,100% and 100%,there was no significant differeces among 3 groups.There were 2 cases ofincomplete abortion(6%)in group 200 mg and these cases were carried out as emergency proceduresbecause of heavy bleedimg;among which one case was transfused 200 ml blood.No case ofcontinuimg pregnancy could be found.Three treatment regiment caused no significant side effectsexcept mild abdominal pain in which analgesics were not required and no significant differeces werefound.There was no differeces in time of expulsion of aminiotic sac after instertion of gemeprost andwere 3.5h,3.2h and 3.2h respectively.However,the duration of bleedimg after treatment ofpregnany was shorter significantly in group 200mg,11.5 days as compared with group 400mg,14.0 days and 600 mg,16.1 days.From above data,for early pregnancy termination with RU486and prostaglandin analogues gemeprost,200 mg single dose of RU486 may be sufficient.