米非司酮联合米索前列醇片应用于瘢痕子宫中期妊娠引产的开放性、阳性药物随机对照临床试验

An open, randomized, positive-drug controlled trial of Mifepristone and Misoprostol Tablets in the treatment of induced labor in the second trimester of pregnancy of scarred uterus

目的 探讨米非司酮联合米索前列醇片用于16 ～ 24周瘢痕子宫中期妊娠引产的疗效.方法 根据入选、排除标准,入选140例16～24周的瘢痕子宫的妊娠妇女,孕妇自愿选择终止妊娠,随机分为两组,治疗组70例,给予米非司酮联合米索前列醇终止妊娠,对照组A 70例,则应用非司酮联合羊膜腔内注射利凡诺针终止妊娠.选取同期子宫孕16～24周的非瘢痕子宫病例70例,采用米非司酮联合米索前列醇片终止妊娠,作为对照组B.评价三组引产成功率、引产后出血量、产程时间、术前紧张、不完全流产率等.结果 治疗组引产时间（宫缩时间、胎儿娩出时间、总产程）均显著低于对照组A,完全引产率则明显高于对照组A（51.4％比27.1％,x2=8.655,P=0.003）,差异有高度统计学意义（P＜0.01）.引产过程中治疗组紧张发生率（48.5％比95.7％,x2=38.7,P=0.000）、中重度疼痛率（61.4％比91.4％,x2=17.48,P=0.000）均明显低于对照组A.引产过程,胎盘残留发生率治疗组可能更低（18.5％比41.4％,x2=8.707,P=0.003）.治疗组与对照组B比较显示,在引产时间、完全引产率、并发症发生率差异均无统计学意义（P＞0.05）.结论 相比于米非司酮联合利凡诺,联合米索前列醇片引产产程时间更短,孕妇紧张发生率、引产并发症更少,对医务人员技术要求更低.

Objective To study the clinical effect of Mifepristone and Misoprostol Tablets in treatment of 16-24 weeks of induced labor in the second trimester of pregnancy of scarred uterus.Methods The multiple center,randomized controlled was conducted.140 patients were randomly divided into two groups,70 cases of the treatment group were treated with Mifepristone and Misoprostol and 70 cases of the control group A were treated with Mifepristone and Rivanol,70 cases of 16-24 weeks pregnant women without scarred uterus at the same time were chosen,and treated with Mifepristone and Misoprostol Tablets to terminate opregnancy,whom were as control group B.The success rate of induced labor,bleeding after induced labor,birth course,preoperative nervous,incomplete abortion rate of the three groups were assessed.Results Induced labor time （contractions time,fetal childbirth time,total stage of labor） of treatment group were lower than the control group A （P 〈 0.01）.Complete induced labor rate of treatment group were superior to the control group A （51.4% vs 27.1%,x-2=8.655,P =0.003）.Incidence of tension （48.5% vs 95.7%,x2=38.7,P =0.000） and rate of moderately severe pain （61.4% vs 91.4%,x2=17.48,P =0.000） of treatment group were lower than the control group A,and the placenta rate were lower in Misoprostol group （18.5% vs 41.4%,x2=8.707,P =0.003）.There were no significant differences of induced labor time,complete induced labor rate,incidence rate of complications between treatment group and control group B （P 〉 0.05）.Conclusion Misoprostol has shorter induced labor time,lower placenta rate,incidence of tension,and the requirement for medical staff is lower,when comparing with Rivanol.