地诺前列酮栓促宫颈成熟疗效与安全性的随机对照试验

Efficacy and safety of dinoprostone suppositories in treatment for promoting cervical ripening：a randomized controlled trial

目的 探讨地诺前列酮栓促宫颈成熟的疗效与安全性. 方法 研究设计为随机对照试验.采用信封抽签法,将2011年9月至2013年9月在中国医科大学盛京医院住院、宫颈条件不成熟的足月妊娠妇女随机分为地诺前列酮栓组（地诺前列酮栓1枚置阴道后穹窿处,12 h后取出）和缩宫素组（缩宫素2.5U入0.9％氯化钠注射液500 ml缓慢静脉滴注）.疗效评价指标措施为用药前及用药后6、12 h的Bishop评分、第一、二、三产程和总产程时间以及阴道分娩率.安全性评价指标为孕妇不良反应、胎儿窘迫和新生儿窒息发生率. 结果 地诺前列酮栓组用药后6、12 h Bishop评分[（6.5±0.8）、（8.3±0.9）分]均高于用药前[（4.2±0.6）分]及缩宫素组[（4.2±0.6）、（4.5±0.3）分],差异均有统计学意义（均P ＜0.05）.地诺前列酮栓组促宫颈成熟的总有效率[85.0％ （221/260）]高于缩宫素组[23.1％ （60/260）],差异有统计学意义（P=0.01）.地诺前列酮栓组第一、二产程和总产程时间均短于缩宫素组,差异均有统计学意义（均P＜0.05）.地诺前列酮栓组阴道分娩率[90.8％（236/260）]高于缩宫素组[46.9％（122/260）],差异有统计学意义（P=0.01）.地诺前列酮栓组孕妇不良反应、胎儿窘迫和新生儿窒息发生率分别为7.0％（18/260）、4.7％（12/256）和3.9％（10/256）;缩宫素组分别为6.2％（16/260）、4.8％ （14/253）、4.3％（11/253）;组间比较差异均无统计学意义（均P ＞0.05）. 结论 地诺前列酮栓促宫颈成熟的作用优于缩宫素,有良好的安全性.

Objective To investigate the efficacy and safety of dinoprostone suppositories in treatment for promoting cervical ripening.Methods A randomized controlled clinical trial was conducted.The full-term pregnant women whose cervical conditions were not ripe in Shengjing Hospital of China Medical University from September 2011 to September 2013 were randomly divided into the dinoprostone suppositories group （one dinoprostone suppository was placed in the posterior vaginal fornix and removed 12 hours later） and the oxytocin group （an intravenous infusion of 2.5 U oxytocin in 0.9% sodium chloride solution for injection 500 ml was infused slowly） by envelope sortition method.The efficacy was evaluated by Bishop score before and 6 and 12 hours after drug administration,the first,second,and third stage labor and total labor time,and the rate of vaginal delivery.Safety evaluation index included the incidence of drug adverse reaction in the pregnant women,fetal distress,and neonatal asphyxia.Results The Bishop scores 6 and 12 hours after drug administration in the dinoprostone suppositories group[（6.5 ± 0.8） and （8.3 ± 0.9）] were higher than the Bishop scores before drug administration in the dinoprostone suppositories group （4.2 ± 0.6） and the Bishop scores 6 and 12 hours after giving the drug in the oxytocin group [（4.2 ±0.6） and （4.5 ± 0.3）],the differences were statistically significant （all P 〈 0.05）.The total effective rate to promote cervical ripening in the dinoprostone suppositories group [85.0% （221/260）] was significantly higher than that in the oxytocin group [23.1% （60/260）] （P =0.01）.The first and second stage labor and total labor time in the dinoprostone suppositories group were significantly shorter than that in the oxytocin group （all P 〈 0.05）.The rate of vaginal delivery in the dinoprostone suppositories group [90.8% （236/ 260）] was significantly higher than that in the oxytocin group [46.9% （122/260）] （P =0.01）.The incidence of drug adverse reaction in the pregnant women,fetal distress,and neonatal asphyxia were respectively 7.0% （18/260）,4.7% （12/256）,and 3.9% （10/256） in the dinoprostone suppositories group and were respectively 6.2% （16/260）,4.8% （14/253）,and 4.3% （11/253） in the oxytocin group,there were no statistically significant differences between the two groups （all P 〉 0.05）.Conclusion The efficacy of dinoprostone suppositories for promoting cervical ripening was better than oxytocin and dinoprostone suppository showed a good safety profile.