Nuutila M, Kajanoja P
Departments I and II of Obstetrics and Gynecology, Helsinki University Central Hospital, Finland.
Acta Obstet Gynecol Scand. 1996 Feb;75(2):135-8. doi: 10.3109/00016349609033305.
Although there are many comparative studies concerning the local administration of prostaglandin E2 gel for cervical ripening and labor induction, the safety, efficacy and the appropriate route and dose of the gel are still debated.
One hundred and ten women with high-risk pregnancy and unripe cervix received prostaglandin E2 gel 1 mg intravaginally (n=35), 2 mg intravaginally (n=36) and 0.5 mg intracervically (n=39), maximally three times at 6-hour intervals for cervical ripening prior to labor induction. The safety, efficacy and optimal dose were assessed.
The 2 mg intravaginal gel and the 0.5 mg intracervical gel were equally effective and more effective than the 1 mg intravaginal gel in labor characteristics such as ripening time and cesarean section rate, but not in labor time. However, the failure rate (labor could not be induced) was highest in the intracervical group (10.3%) compared to the intravaginal groups (2.9% and 2.8%), although the differences were not statistically significant. In the two intravaginal groups three and five patients received the third gel application and one patient in both groups could not be induced. In the intracervical group the ripening of the cervix failed in all patients, who received the third gel. The neonatal outcome was uneventful in all groups. There were two cases of uterine hypertonus associated with fetal bradycardia, one in the intracervical and one in the 2 mg intravaginal group. Thus careful fetal monitoring is necessary. Furthermore, the vaginal route has the advantage of an easier technique of administration and obviously lower risk for inadvertent extraamnial instillation.
We recommend the use of multiple applications of 2 mg intravaginal prostaglandin E2 gel as a safe, effective and easy method for preinduction cervical ripening in high-risk pregnancies. More than three gel applications hardly increase the efficacy.
尽管有许多关于局部应用前列腺素E2凝胶进行宫颈成熟和引产的比较研究，但该凝胶的安全性、有效性以及合适的给药途径和剂量仍存在争议。
110例高危妊娠且宫颈未成熟的女性接受了前列腺素E2凝胶引产，其中35例经阴道给予1mg凝胶，36例经阴道给予2mg凝胶，39例经宫颈给予0.5mg凝胶，最大给药次数为3次，间隔6小时，用于引产前行宫颈成熟。评估了安全性、有效性和最佳剂量。
2mg经阴道凝胶和0.5mg经宫颈凝胶在宫颈成熟时间和剖宫产率等分娩特征方面同样有效且比1mg经阴道凝胶更有效，但在产程时间方面并非如此。然而，经宫颈组的失败率（无法引产）最高（10.3%），高于经阴道组（2.9%和2.8%），尽管差异无统计学意义。在两个经阴道组中，分别有3例和5例患者接受了第三次凝胶给药，两组各有1例患者无法引产。在经宫颈组中，所有接受第三次凝胶给药的患者宫颈成熟均失败。所有组的新生儿结局均良好。有2例子宫过度收缩伴胎儿心动过缓，1例在经宫颈组，1例在2mg经阴道组。因此，需要仔细监测胎儿。此外，经阴道途径具有给药技术更简便且意外羊膜外滴注风险明显更低的优势。
我们推荐多次应用2mg经阴道前列腺素E2凝胶作为高危妊娠引产前行宫颈成熟的一种安全、有效且简便的方法。超过三次应用凝胶几乎不会增加疗效。
