Denoual-Ziad C, Hors Y, Delande I, Lezin B, Herlicoviez M, Dreyfus M
Service Gynécologie-Obstétrique et Médecine de la Reproduction, CHU, Caen.
J Gynecol Obstet Biol Reprod (Paris). 2005 Feb;34(1 Pt 1):62-8. doi: 10.1016/s0368-2315(05)82672-9.
To compare efficiency for slow release vaginal insert and vaginal gel in current practice.
This retrospective historical study included 171 women: 85 with vaginal insert (Propess, Ferring) and 86 with vaginal gel (Prostine 2mg, Pharmacia). Inclusion criterion were Bishop score 5, singleton pregnancy, vertex presentation, unruptured membranes, and patients with only one prior cesarean delivery were not excluded. Indications for cervical ripening were post-term pregnancy, maternal or fetal pathologies, convenience. The outcomes were vaginal delivery within 12 and 24 hours, cesarean section rate, mean time to delivery, uterine hyperstimulation rate and cost. The statistical analysis was done with Pearson chi2, Student test exact Fisher and U Mann-Whitney tests.
Comparing vaginal insert to vaginal gel, no significant differences appeared for vaginal delivery by 24 hours (53% versus 58%), cesarean section (17.6% versus 19.7%) and mean time to delivery (23.8h versus 22.4h). Labor induction rate within the primipara subgroup was significantly reduced with vaginal gel (39% versus 63.6%; p=0.03) but the rate and time of vaginal delivery were similar. In the same population, the rate of uterine hyperstimulation was higher (9.8% versus 0%; p=0.05) with vaginal gel. Cost of treatment was lowered with vaginal insert.
The dinoprostone vaginal insert for cervical ripening seems to have the same efficiency as vaginal 2mg gel. The cost of treatment appears to be lower, probably because only a single dose is necessary. Use of prostaglandine gel after vaginal insert is not accepted as a gold standard for cervical ripening though our conclusions only concern this retrospective study.
比较当前临床实践中缓释阴道栓剂和阴道凝胶的有效性。
这项回顾性历史研究纳入了171名女性:85名使用阴道栓剂(普贝生,辉凌制药),86名使用阴道凝胶(普罗斯汀2mg,辉瑞制药)。纳入标准为 Bishop 评分5分、单胎妊娠、头先露、胎膜未破,且既往仅行一次剖宫产的患者不被排除。宫颈成熟的指征为过期妊娠、母体或胎儿疾病、便利性。观察指标为12小时和24小时内阴道分娩情况、剖宫产率、平均分娩时间、子宫过度刺激率及费用。采用Pearson卡方检验、Student检验、确切概率法Fisher检验和U Mann-Whitney检验进行统计学分析。
比较阴道栓剂和阴道凝胶,24小时内阴道分娩(53%对58%)、剖宫产(17.6%对19.7%)及平均分娩时间(23.8小时对22.4小时)均无显著差异。初产妇亚组中,阴道凝胶的引产率显著降低(39%对63.6%;p = 0.03),但阴道分娩率和时间相似。在同一人群中,阴道凝胶的子宫过度刺激率更高(9.8%对0%;p = 0.05)。阴道栓剂的治疗费用更低。
用于宫颈成熟的地诺前列酮阴道栓剂似乎与2mg阴道凝胶具有相同的有效性。治疗费用似乎更低,可能是因为只需一剂。尽管我们的结论仅涉及这项回顾性研究,但阴道栓剂后使用前列腺素凝胶并非宫颈成熟的金标准。