Osman Inass, MacKenzie Fiona, Norrie John, Murray Heather M, Greer Ian A, Norman Jane E
Division of Developmental Medicine, University of Glasgow, Glasgow Royal Infirmary, United Kingdom.
Am J Obstet Gynecol. 2006 Apr;194(4):1012-21. doi: 10.1016/j.ajog.2005.10.812.
The purpose of this study was to compare the efficacy and safety profile of prostaglandin E2 with isosorbide mononitrate for cervical ripening before the induction of labor at term.
Primigravid women were assigned randomly to receive either 40 mg of isosorbide mononitrate or 2 mg of prostaglandin E2. Efficacy outcomes were the cervical ripening effect of each agent and the time from treatment initiation to delivery. Safety outcomes were the incidence and frequency of maternal side effects and events that would be potentially hazardous for mother and baby during outpatient cervical ripening.
Prostaglandin E2 was more effective than isosorbide mononitrate in inducing a change in modified Bishop score. Mean duration from treatment initiation to delivery was greater for isosorbide mononitrate than prostaglandin E2. There were no adverse events in the isosorbide mononitrate group that would contraindicate outpatient treatment. However, in the prostaglandin E2 group, 7% of the pregnancies had abnormal fetal heart rate patterns (P = .0002). Maternal satisfaction was significantly higher in the isosorbide mononitrate group.
Although isosorbide mononitrate was less effective, maternal satisfaction was significantly greater. The safety profile of each agent was such that it would be reasonable to give isosorbide mononitrate, but not prostaglandin E2, on an outpatient basis.
本研究旨在比较足月引产术前使用前列腺素E2与单硝酸异山梨酯进行宫颈成熟的疗效和安全性。
初产妇被随机分配接受40mg单硝酸异山梨酯或2mg前列腺素E2。疗效指标为每种药物的宫颈成熟效果以及从开始治疗到分娩的时间。安全性指标为产妇副作用的发生率和频率，以及门诊宫颈成熟期间对母婴有潜在危害的事件。
在诱导改良Bishop评分变化方面，前列腺素E2比单硝酸异山梨酯更有效。单硝酸异山梨酯从开始治疗到分娩的平均持续时间比前列腺素E2更长。单硝酸异山梨酯组没有出现禁止门诊治疗的不良事件。然而，在前列腺素E2组中，7%的妊娠出现了异常胎心率模式（P = 0.0002）。单硝酸异山梨酯组产妇满意度显著更高。
虽然单硝酸异山梨酯效果较差，但产妇满意度显著更高。每种药物的安全性表明，在门诊给予单硝酸异山梨酯是合理的，但不适合给予前列腺素E2。
