缩宫素单用与联用罂粟碱在初产妇导管促宫颈成熟后引产的随机对照试验
这项双盲随机对照试验纳入126例足月单胎头位、经Foley导管促宫颈成熟后引产的初产妇，在启动缩宫素时按1:1给予静脉罂粟碱80 mg或安慰剂。两组从缩宫素启动至活跃产程的中位时间无差异，但罂粟碱组剖宫产率更低（9.5% vs 22.2%），因引产失败或产程停滞的剖宫产更少，破膜至分娩时间更短，产后住院更短；新生儿结局两组相当。
要点
- 罂粟碱未缩短缩宫素启动至活跃产程的中位时间（6.7 vs 6.9小时，P=.881）。
- 罂粟碱组剖宫产率更低（9.5% vs 22.2%，RR 0.429，95%CI 0.209-0.881，P=.021）。
- 因引产失败或产程停滞的剖宫产更少（4.8% vs 19.0%，RR 0.250，95%CI 0.105-0.594，P=.002）。
核心结论
- 在Foley导管促宫颈成熟后的初产妇引产中，缩宫素联用罂粟碱未缩短至活跃产程的中位时间，但降低了剖宫产率（尤其因引产失败或产程停滞者），缩短了破膜至分娩时间和产后住院时间，并降低了破膜超过18小时的发生率，新生儿不良结局率相似。
研究设计与样本
- 双盲随机对照试验，126例足月单胎头位、经Foley导管促宫颈成熟后引产的初产妇，按1:1随机接受静脉罂粟碱80 mg或安慰剂，均于缩宫素启动时给药；按意向性治疗原则分析。
主要发现
- 从缩宫素启动至活跃产程（宫颈扩张≥6 cm伴规律宫缩）的中位时间两组无差异：6.7小时（IQR 4.3-21.8）vs 6.9小时（IQR 4.1-15.4），P=.881。
- 罂粟碱组剖宫产率9.5% vs 22.2%（RR 0.429，95%CI 0.209-0.881，P=.021）。
- 因引产失败或产程停滞的剖宫产率4.8% vs 19.0%（RR 0.250，95%CI 0.105-0.594，P=.002）。
- 罂粟碱组破膜至分娩时间更短（P=.04），破膜超过18小时的发生率更低，产后平均住院时间更短（P=.034）；新生儿结局两组相当。
关键数值与推荐
- 主要结局为缩宫素启动至活跃产程（宫颈扩张≥6 cm伴规律宫缩）的时间，两组中位数无统计学差异（P=.881）。
- 罂粟碱剂量为静脉80 mg，于缩宫素启动时给予，安慰剂对照。
- 剖宫产率及因引产失败或产程停滞的剖宫产率在罂粟碱组均显著降低（P=.021与P=.002）。
临床怎么用
- 对Foley导管促宫颈成熟后需缩宫素引产的足月单胎头位初产妇，可考虑在启动缩宫素时加用静脉罂粟碱80 mg，以降低剖宫产率、尤其因引产失败或产程停滞者，并可能缩短产后住院时间。
- 该干预不缩短至活跃产程的时间，用药决策应结合剖宫产风险与住院时长等综合评估。
- 用药后新生儿结局与安慰剂相当，仍需常规新生儿监护。
局限性
- 为单中心随机对照试验，样本量126例，结论外推需谨慎。
- 主要结局为阴性，剖宫产率等为次要结局，可能存在多重比较问题。
- 未报告罂粟碱的不良反应、母体血流动力学影响及 blinds 实施细节等信息。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
BACKGROUND: Labor induction in primiparous women following mechanical cervical ripening is frequently prolonged and associated with an increased risk of cesarean delivery. Papaverine, a smooth muscle relaxant, may enhance cervical compliance; however, its role when administered after catheter removal and at the initiation of oxytocin remains unclear. OBJECTIVE: To assess whether the addition of intravenous papaverine to oxytocin shortens the time to active labor in primiparous women undergoing induction after Foley catheter ripening. STUDY DESIGN: In this double-blind randomized controlled trial, 126 primiparous women at term with singleton cephalic pregnancies undergoing cervical ripening with a Foley catheter were randomized 1:1 to receive intravenous papaverine (80 mg) or placebo at oxytocin initiation. The primary outcome was the time from oxytocin initiation to active labor (≥6 cm cervical dilation with regular contractions). Secondary endpoints included measures of labor progression, delivery mode, maternal complications, the duration of hospital stay, and neonatal outcomes. All the analyses were performed under an intention-to-treat principle. RESULTS: The median time from oxytocin initiation to active labor did not differ between the papaverine and placebo groups (6.7 hours [interquartile range (IQR) 4.3-21.8] vs 6.9 hours [IQR 4.1-15.4]; P=.881). Cesarean delivery was less frequent in the papaverine group (9.5% vs 22.2%; relative risk 0.429, 95% confidence interval (CI) 0.209-0.881; P=.021), particularly for failed induction or nonprogressive labor (4.8% vs 19.0%; relative risk 0.250, 95% CI, 0.105-0.594; P=.002). Papaverine was also associated with a shorter duration of membrane rupture (P=.04), a lower rate of prolonged rupture of membranes (>18 hours) and a shorter mean postpartum hospital stay (P=.034). Neonatal outcomes were comparable between the groups. CONCLUSION: The median time to active labor was not shorter following papaverine administration compared to a placebo. However, the rate of cesarean delivery for failed induction or labor arrest was lower, the median hospital stay was shorter, and the rate of prolonged rupture of membranes was lower (>18 hours). Rates of adverse neonatal outcomes were similar.
引用
- Ganem N, Wolf MF, Diab R, et al. Oxytocin alone versus oxytocin plus papaverine for labor induction in primiparous women after catheter ripening: a randomized controlled trial. Am J Obstet Gynecol MFM. 2026. PMID: 42144074. doi:10.1016/j.ajogmf.2026.101995
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。