Taylor S J, Peat J K, Armour C L
Department of Pharmacy, University of Sydney, NSW, Australia.
J Clin Pharm Ther. 1999 Aug;24(4):303-10. doi: 10.1046/j.1365-2710.1999.00229.x.
The purpose of this study was to investigate the effectiveness of prostaglandin E2 vaginal gel as used in practice, rather than its efficacy as assessed in randomised, controlled, clinical trials. This product is used to ripen the cervix prior to induction of labour, sometimes making unnecessary the use of the standard treatment for induction, artificial rupture of the membranes (ARM) plus oxytocin. In this study, effectiveness of the gel was assessed in terms of changes in mode of delivery, and in particular the risk of Caesarean section.
An historical control was used and the risk of Caesarean section for women induced in the 1990/91 (before the introduction of the gel) was compared with that for women induced in 1992/93 (after the introduction of the gel). Maternal characteristics which may have been different in the two groups and factors which might influence the risk of Caesarean section were controlled for statistically using logistic regression, thus reducing any bias towards one group.
After adjusting for the factors which had a significant effect on the process of labour from induction to birth, it was found that the risk of Caesarean section was not significantly lower in the 1992/93-time period, when the gel was in regular use, from that in the 2 years prior to its introduction (Odds ratio 1.09, CI95% 0.88, 1.36).
Following the introduction of PGE2 gel, no difference in effectiveness, as measured in terms of mode of delivery, was detected in this study of practice, which included patients with more complex obstetric problems.
本研究的目的是调查前列腺素E2阴道凝胶在实际应用中的有效性，而非在随机对照临床试验中评估的疗效。该产品用于在引产之前使宫颈成熟，有时可避免使用引产的标准治疗方法——人工破膜（ARM）加催产素。在本研究中，根据分娩方式的变化，特别是剖宫产风险，评估了该凝胶的有效性。
采用历史对照，将1990/91年（凝胶引入之前）引产的女性的剖宫产风险与1992/93年（凝胶引入之后）引产的女性的剖宫产风险进行比较。使用逻辑回归对两组中可能不同的产妇特征以及可能影响剖宫产风险的因素进行统计学控制，从而减少对一组的任何偏倚。
在对从引产到分娩过程中有显著影响的因素进行调整后，发现1992/93年（凝胶经常使用）剖宫产风险与引入前两年相比没有显著降低（优势比1.09，95%置信区间0.88，1.36）。
在本项纳入了有更复杂产科问题患者的实际应用研究中，引入PGE2凝胶后，在分娩方式方面未检测到有效性差异。
