米非司酮用于足月妊娠引产的安全性研究

The safety of induced labor with mifepristone for term pregnancy.

目的 探讨米非司酮用于足月妊娠引产对胎儿的安全性。方法 收集我院 1997年 3月至 8月、2 0 0 0年 4月至 2 0 0 2年 5月住院待产妇 2 0 0例 ,随机分为试验组 80例 ,对照 1组和 2组各 6 0例 ,试验组口服米非司酮 2 5mgbid× 3d ,对照组 1缩宫素 2 5U + 5 %GS 5 0 0ml静脉缓滴qd× 3d ,对照组 2不予任何药物 ,自然分娩。对受试者用药前后母血浆及脐血浆内皮素 (ET 1)水平作同步监测。产后对胎盘绒毛的显微及超微结构进行分析。结果 用药前试验组及对照组 1、2血浆ET 1(pg/mg)分别为 74 32± 18 6 2、72 79± 32 80、76 0 2± 2 8 5 7,P >0 0 5。用药后试验组与对照组 1、ET 1为 76 6 8± 2 5 4 4、79 82± 2 3 75 ,与用药前三组两两比较P >0 0 5。胎盘光镜观察 :三组绒毛、合体滋养细胞清晰完整 ,合体细胞结节、三级绒毛干及肌性小动脉计数P值均 >0 0 5。电镜观察 :试验组、对照组 2合体滋养细胞表面微绒毛丰富、清晰。胞浆内溶酶体、线粒体等重要细胞器形态正常 ,结构完整。细胞核核膜完整 ,未见核固缩及核碎裂。新生儿结局 :三组新生儿Apgar评分 >7。结论 米非司酮用于足月妊娠引产未引起绒毛血管内皮细胞及胎儿内皮细胞损伤 ,ET水平正常 ,新生儿结局良好 ,是一种可供选择的引产新药。

Objective To assess the safety of induced labor with mifepristone for term pregnancy. Methods 200 eligible subjects were randomly divided into study group,control group 1 and control group 2. Mifepristone(25mg,bid×3) was given in study group,Oxytocin(2.5U+5% GS 500 ml,iv gtt slowly,qd×3) was given in control group 1 and nothing in the control group 2. The endothelin 1(ET-1) levels of maternal blood in three groups were tested before mifepristone and oxytocin were given. And the ET-1 levels of study group and control group 1 were also tested at 24h after mifepristone and oxytocin were given. Besides,the ET-1 levels of cord blood in three groups were tested. The structure of the placental villus were analysed after labour. Results The ET-1 levels of maternal blood had no significant difference between the three groups before mifepristone and oxytocin were given,P>0.05. At 24h after mifepristone and oxytocin were given,the ET-1 levels of study group and control group 1 had no significanct difference,compared with ET-1 levels of three groups mentioned above. The ET-1 levels of cord blood had no significant difference between three groups,P>0.05. The numbers of the syncytial knot,the villus stem of gradeⅢ,and the minor artery were the same,P>0.05. The structure of the villus and the syncytial cells in three groups had no changes. The lysosome,mitochondrion,ribosome and others within the syncytial cells in study group and control group 2 were normal. The neonatal Apgar scores in three groups were>7. Conclusion Mifepristone is safe and has no side-effects for the induced labor of term pregnancy.