足月妊娠引产用阴道前列腺素(前列腺素E2和前列腺素F2α)
Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term.
作者信息
Kelly A J, Kavanagh J, Thomas J
机构信息
Clinical Effectiveness Support Unit, Royal College of Obstetricians and Gynaecologists, 27 Sussex Place, Regent's Park, London, UK, NW1 4RG.
出版信息
Cochrane Database Syst Rev. 2001(2):CD003101. doi: 10.1002/14651858.CD003101.
BACKGROUND
Prostaglandins have been used for induction of labour since the 1960s. Initial work focused on prostaglandin F2a as prostaglandin E2 was considered unsuitable for a number of reasons. With the development of alternative routes of administration, comparisons were made between various formulations of vaginal prostaglandins. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology.
OBJECTIVES
To determine the effects of vaginal prostaglandins E2 and F2a for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment or other vaginal prostaglandins (except Misoprostol).
SEARCH STRATEGY
The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled trials register and bibliographies of relevant papers. Last searched: November 2000.
SELECTION CRITERIA
The criteria for inclusion included the following: (1) clinical trials comparing vaginal prostaglandins used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions.
DATA COLLECTION AND ANALYSIS
A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. The initial data extraction was done centrally, and incorporated into a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. The data was then extracted from the primary reviews into a series of secondary reviews, arranged by category of woman. To avoid duplication of data in the primary reviews, the labour induction methods were listed in a specific order, from one to 23. Each primary review included comparisons between one of the methods (from two to 23) with only those methods above it on the list.
MAIN RESULTS
In total, 94 studies were considered; 42 have been excluded and 52 included examining a total of 9402 women. Vaginal prostaglandin E2 compared with placebo or no treatment reduced the likelihood of vaginal delivery not being achieved within 24 hours (18% vs. 99%, RR 0.19, 95% CI 0.14,0.25), the caesarean section rates were not different between groups although the risk of uterine hyperstimulation with fetal heart rate changes was increased (4.6% vs. 0.51%, RR 4.14, 95% CI 1.93, 8.90). Comparison of vaginal prostaglandin F2a with placebo showed no increase in caesarean section rates but the cervical score was more likely to be improved (15% vs. 60%, RR 0.25, 95% CI 0.13,0.49), and the risk of oxytocin augmentation reduced (53.9% vs. 89.1%, RR 0.60, 95% CI 0.43,0.84) with the use of vaginal PGF2a. There were insufficient data to make meaningful conclusions for the comparison of vaginal PGE2 and PGF2a. PGE2 tablet, gel and pessary appear to be as efficacious as each other. Lower dose regimes, as defined in the review, appear as efficacious as higher dose regimes.
REVIEWER'S CONCLUSIONS: The primary aim of this review was to examine the efficacy of vaginal prostaglandin E2 and F2a. This is reflected by an increase in successful vaginal delivery rates in 24 hours, no increase in operative delivery rates and significant improvements in cervical favourability within 24-48 hours. Further research is needed to quantify the cost-analysis of induction of labour with vaginal prostaglandins, with special attention to different methods of administration.
背景
自20世纪60年代以来,前列腺素一直被用于引产。最初的研究重点是前列腺素F2α,因为前列腺素E2由于多种原因被认为不适用。随着给药途径的发展,人们对各种阴道用前列腺素制剂进行了比较。这是一系列使用标准化方法对宫颈成熟和引产方法进行的综述之一。
目的
比较阴道用前列腺素E2和F2α与安慰剂/未治疗或其他阴道用前列腺素(米索前列醇除外)用于孕晚期宫颈成熟或引产的效果。
检索策略
Cochrane妊娠与分娩组试验注册库、Cochrane对照试验注册库以及相关论文的参考文献。最近一次检索时间:2000年11月。
入选标准
入选标准如下:(1)临床试验,将用于孕晚期宫颈成熟或引产的阴道用前列腺素与安慰剂/未治疗或在预定义引产方法列表中位于其上方的其他方法进行比较;(2)随机分配至治疗组或对照组;(3)充分的分配隐藏;(4)违反分配管理但不足以实质性影响结论;(5)报告有临床意义的结局指标;(6)可根据随机分配进行分析的数据;(7)缺失数据不足以实质性影响结论。
数据收集与分析
已制定一种策略来处理与引产相关的大量且复杂的试验数据。这涉及两阶段的数据提取方法。初始数据提取在中心进行,并按照标准化方法纳入一系列按引产方法排列的主要综述中。然后将数据从主要综述中提取到一系列按女性类别排列的次要综述中。为避免在主要综述中数据重复,引产方法按特定顺序列出,从1到23。每项主要综述包括其中一种方法(从2到23)与列表中其上方的那些方法之间的比较。
主要结果
总共考虑了94项研究;排除了42项,纳入了52项,共涉及9402名女性。与安慰剂或未治疗相比,阴道用前列腺素E2降低了24小时内未实现阴道分娩的可能性(18%对99%,RR 0.19,95%CI 0.14,0.25),尽管伴有胎儿心率变化的子宫过度刺激风险增加(4.6%对0.51%,RR 4.14,95%CI 1.93,8.90),但两组剖宫产率无差异。阴道用前列腺素F2α与安慰剂比较显示剖宫产率未增加,但宫颈评分更有可能改善(15%对60%,RR 0.25,95%CI 0.13,0.49),并且使用阴道用PGF2α后催产素增加的风险降低(53.9%对89.1%,RR 0.60,95%CI 0.43,0.84)。对于阴道用PGE2和PGF2α的比较,数据不足无法得出有意义的结论。PGE2片剂、凝胶和阴道环似乎彼此效果相同。综述中定义的较低剂量方案似乎与较高剂量方案效果相同。
综述作者结论
本综述的主要目的是研究阴道用前列腺素E2和F2α的疗效。这体现在24小时内成功阴道分娩率增加、手术分娩率未增加以及24 - 48小时内宫颈成熟度显著改善。需要进一步研究来量化阴道用前列腺素引产的成本分析,特别关注不同的给药方法。