MacLennan A H, Green R C, Bryant-Greenwood G D, Greenwood F C, Seamark R F
Obstet Gynecol. 1981 Nov;58(5):601-4.
The first of a 2-part trial consisted of a double-blind randomized pilot study in which 4 groups of 10 patients near term received 1 of the following hormonal combinations in a vaginal gel 15 hours before surgical induction of labor: 1) prostaglandin F2 alpha (PGF2 alpha) and relaxin; 2) relaxin and estradiol; 3) estradiol and PGF2 alpha; and 4) relaxin, estradiol, and PGF2 alpha. In each group the mean cervical score improved after treatment; the relaxin/PGF2 alpha combination was associated with the greatest improvement in cervical score (4.8). The highest incidence of subsequent labor was also seen in the relaxin/PGF2 alpha group (40%). However, with the exception of the latter group, the clinical effects of these hormonal combinations were neither greater nor smaller than the previously published effects of these hormones used individually in similar circumstances. The second part of the study further explored the possibility of an additive effect of relaxin and PGF2 alpha in combination as suggested by the pilot study, and an additional 40 patients were given this combination. Analysis of these larger numbers showed no additive effect when these hormones were used in combination compared with when they were used individually. Thus, in the circumstances described, there is no clinical advantage to the concurrent administration of any combination of relaxin, PGF2 alpha and estradiol with regard to cervical ripening and/or the initiation of parturition.
这项分为两部分的试验的第一部分是一项双盲随机试点研究，其中4组各10名足月孕妇在引产手术前15小时接受以下激素组合之一的阴道凝胶给药：1）前列腺素F2α（PGF2α）和松弛素；2）松弛素和雌二醇；3）雌二醇和PGF2α；4）松弛素、雌二醇和PGF2α。每组治疗后宫颈评分均有改善；松弛素/PGF2α组合使宫颈评分改善最大（4.8）。松弛素/PGF2α组随后分娩的发生率也最高（40%）。然而，除了后一组外，这些激素组合的临床效果并不比之前在类似情况下单独使用这些激素所公布的效果更好或更差。该研究的第二部分进一步探讨了试点研究中所提示的松弛素和PGF2α联合使用的相加效应的可能性，另外40名患者接受了这种组合。对这些更多病例的分析表明，与单独使用这些激素相比，联合使用时没有相加效应。因此，在所述情况下，同时给予松弛素、PGF2α和雌二醇的任何组合在宫颈成熟和/或发动分娩方面没有临床优势。
