米索前列醇与依沙吖啶配伍用于中孕引产的多中心临床研究

A multicenter randomized controlled clinical trial of combined misoprostol and ethacridine in induction labor of middle-trimester pregnancy

目的 探索并验证一种安全有效、简便易行、能够明显缩短中期妊娠引产时间的新方法。方法 在 4家医疗单位中 ,选择 14～ 2 2孕周需要引产的健康妊娠妇女共 12 2例 ,随机分成 2组。研究组共 64例 ,先按常规行羊膜腔穿刺注入依沙吖啶 10 0mg ,术毕即于阴道后穹窿处放置米索前列醇 2片 (0 .4mg/片 ) ;对照组共5 8例 ,以甲硝唑片 2片 (0 .4g/片 )取代米索前列醇片。结果 研究组单次引产成功率 (96.9% )高于对照组 (82 .8% ) ,差异有显著性 (P <0 .0 1) ;研究组胎儿排出时间为 (2 8.8± 17.2 )h ,短于对照组的 (5 0 .2± 10 .9)h ,差异有显著性 (P <0 .0 0 1) ;与对照组相比 ,研究组产后出血较少 ,胎盘排出、宫内组织残留以及产后恢复等均未受明显影响 ,无一例出现强直性宫缩 ,也不增加各种并发症和不良反应的发生率。结论 米索前列醇配伍依沙吖啶引产法明显提高单次引产的成功率 ,大大缩短引产所需的时间。只要严格掌握适应证 ,这是一种安全、高效、廉价。

Objective To probe and verify a new safe, effective, simple and easy induction method for middle trimester pregnancy with significantly shorter induction time. Methods 122 induction desiring cases with gestational week of 14.0～22.0 were randomly divided into two groups. Ethacridine 100 mg was injected routinely into the amnionic cavity and two tablets of misoprostol (0.4 mg for the study group of 64 cases) or metronidazole (0.4 g for the control group of 58 cases) were placed into the vagina just after the injection. Results The successful rates of single induction and fetal delivery time were 96.9% versus 82.8% ( P <0.01) and (28.8±17.2) hours versus (50.2± 10.9) hours ( P <0.001) respectively in the study and control group. The amount of postpartum hemorrhage was lesser in the study group.There were no significant differences between the two groups in placenta delivery time, the amount of intrauterine tissue remnant, post induction recovery and the incidence of side reactions or effects. No obvious complications occurred such as tetanus uterine contraction and so on. Conclusion The induction method of combined misoprostol and ethacridine can dramatically increase the successful rate of single induction and reduce induction time. It is a safe, reliable and high effective induction method for properly selected cases.