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比较两种地诺前列酮制剂用于足月引产时促宫颈成熟的效果。一项随机试验。

Comparing two dinoprostone agents for preinduction cervical ripening at term. A randomized trial.

作者信息

Wieland D, Friedman F

机构信息

Department of Obstetrics and Gynecology, Jacobi Medical Center, Bronx, NY 10461, USA.

出版信息

J Reprod Med. 1999 Aug;44(8):724-8.

Abstract

OBJECTIVE

To compare the safety, efficacy and cost of two methods of administering commercially available dinoprostone for preinduction cervical ripening at term.

STUDY DESIGN

Sixty-nine women admitted for labor induction were randomized to receive one of two commercially available agents for cervical ripening. Half the patients received a gel containing 0.5 mg of dinoprostone placed intracervically every four hours. The other half received a polymer insert containing 10 mg of dinoprostone intravaginally. After 12 hours of cervical ripening, oxytocin was given and amniotomy performed to induce labor.

RESULTS

Among 69 women randomized, 35 received the gel and 34 the polymer. No significant differences were noted between the two groups in starting characteristics or indication for induction. Both groups were similar with respect to change in Bishop score, start-to-delivery interval, amount of oxytocin required, mode of delivery and success of induction. A slightly higher rate of hyperstimulation was noted in the polymer group, although this did not lead to fetal or maternal morbidity. The average costs per patient for the two agents were similar.

CONCLUSION

The two dinoprostone agents are similar with respect to efficacy. The polymer group had slightly more complications but without adverse fetal or maternal outcomes. A larger, multicenter trial would be required to determine actual differences in the efficacy, safety and cost of these two agents.

摘要

目的

比较两种使用市售地诺前列酮进行足月引产术前宫颈成熟的方法的安全性、有效性和成本。

研究设计

69名因引产入院的女性被随机分配接受两种市售宫颈成熟药物中的一种。一半患者每4小时接受一次宫颈内放置含0.5毫克地诺前列酮的凝胶。另一半患者阴道内接受含10毫克地诺前列酮的聚合物栓剂。宫颈成熟12小时后,给予催产素并进行人工破膜以引产。

结果

在随机分组的69名女性中,35名接受凝胶,34名接受聚合物栓剂。两组在起始特征或引产指征方面无显著差异。两组在 Bishop 评分变化、开始至分娩间隔、所需催产素量、分娩方式和引产成功率方面相似。聚合物组中高刺激率略高,尽管这并未导致胎儿或母亲发病。两种药物的人均平均成本相似。

结论

两种地诺前列酮药物在有效性方面相似。聚合物组并发症略多,但未出现不良胎儿或母亲结局。需要进行更大规模的多中心试验来确定这两种药物在有效性、安全性和成本方面的实际差异。

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